nct_id,nlm_download_date_description,study_first_submitted_date,results_first_submitted_date,disposition_first_submitted_date,last_update_submitted_date,study_first_submitted_qc_date,study_first_posted_date,study_first_posted_date_type,results_first_submitted_qc_date,results_first_posted_date,results_first_posted_date_type,disposition_first_submitted_qc_date,disposition_first_posted_date,disposition_first_posted_date_type,last_update_submitted_qc_date,last_update_posted_date,last_update_posted_date_type,start_month_year,start_date_type,start_date,verification_month_year,verification_date,completion_month_year,completion_date_type,completion_date,primary_completion_month_year,primary_completion_date_type,primary_completion_date,target_duration,study_type,acronym,baseline_population,brief_title,official_title,overall_status,last_known_status,phase,enrollment,enrollment_type,source,limitations_and_caveats,number_of_arms,number_of_groups,why_stopped,has_expanded_access,expanded_access_type_individual,expanded_access_type_intermediate,expanded_access_type_treatment,has_dmc,is_fda_regulated_drug,is_fda_regulated_device,is_unapproved_device,is_ppsd,is_us_export,biospec_retention,biospec_description,ipd_time_frame,ipd_access_criteria,ipd_url,plan_to_share_ipd,plan_to_share_ipd_description,created_at,updated_at,source_class,delayed_posting,expanded_access_nctid,expanded_access_status_for_nctid,fdaaa801_violation,baseline_type_units_analyzed,patient_registry,completion_year,labels
NCT01236547,,2010-11-05,2021-03-02,,2022-06-28,2010-11-05,2010-11-07,ESTIMATED,2021-04-16,2021-05-14,ACTUAL,,,,2022-06-28,2022-07-19,ACTUAL,2010-10-28,ACTUAL,2010-10-28,2022-05,2022-05-31,2022-05-20,ACTUAL,2022-05-20,2020-03-09,ACTUAL,2020-03-09,,INTERVENTIONAL,,Eligible participants,Intensity-Modulated Radiation Therapy and Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Anaplastic Thyroid Cancer,"A Randomized Phase II Study of Concurrent Intensity Modulated Radiation Therapy (IMRT), Paclitaxel and Pazopanib (NSC 737754)/Placebo, for the Treatment of Anaplastic Thyroid Cancer",COMPLETED,,PHASE2,123.0,ACTUAL,National Cancer Institute (NCI),"One run-in arm was originally planned; more run-in arms added due to amendments to the protocol regimen unrelated to toxicities. In addition, due to higher than projected rates of ineligibility and consent withdrawals, phase II final analysis was amended to be time-driven (3 years of potential follow-up for all eligible phase II participants) instead of event driven (71 deaths of eligible phase II participants), reducing power from 80% (one-sided alpha 0.15) to 77% (one-sided alpha 0.1379),",2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,NIH,,,,,,,2022,1.0
NCT03277586,,2017-09-01,,,2021-01-13,2017-09-06,2017-09-11,ACTUAL,,,,,,,2021-01-13,2021-01-15,ACTUAL,2018-05-29,ACTUAL,2018-05-29,2021-01,2021-01-31,2020-11-30,ACTUAL,2020-11-30,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,EPSD,,Effects of Probiotics on Symptoms of Depression,Effects of Probiotics on Symptoms of Depression,TERMINATED,,PHASE3,28.0,ACTUAL,Queen's University,,2.0,,COVID-19,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,OTHER,,,,,,,2020,0.0
NCT03757715,,2018-11-27,2022-03-20,,2022-08-12,2018-11-27,2018-11-29,ACTUAL,2022-08-12,2022-08-31,ACTUAL,,,,2022-08-12,2022-08-31,ACTUAL,2019-05-20,ACTUAL,2019-05-20,2022-08,2022-08-31,2021-04-12,ACTUAL,2021-04-12,2021-03-12,ACTUAL,2021-03-12,,INTERVENTIONAL,,,Regional Anesthesia to Reduce Opioid Use Following Functional Endoscopic Sinus Surgery,The Role of Regional Anesthesia to Reduce Opioid Requirements Following Functional Endoscopic Sinus Surgery (FESS),COMPLETED,,PHASE4,46.0,ACTUAL,University of Alabama at Birmingham,,2.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2021,1.0
NCT05272813,,2022-02-18,,,2024-07-16,2022-02-28,2022-03-09,ACTUAL,,,,,,,2024-07-16,2024-07-18,ACTUAL,2022-04-28,ACTUAL,2022-04-28,2024-07,2024-07-31,2023-11-28,ACTUAL,2023-11-28,2023-11-28,ACTUAL,2023-11-28,,INTERVENTIONAL,,,A Study to Investigate the Efficacy and Safety of MS-553 in CLL/SLL,A Phase I/II Study to Investigate the Efficacy and Safety of MS-553 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma,TERMINATED,,PHASE1/PHASE2,13.0,ACTUAL,"MingSight Pharmaceuticals, Inc",,4.0,,The study is terminated due to major protocol revisions.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,INDUSTRY,,,,,,,2023,0.0
NCT05260541,,2022-02-18,,,2022-11-28,2022-02-18,2022-03-02,ACTUAL,,,,,,,2022-11-28,2022-12-01,ACTUAL,2022-01-25,ACTUAL,2022-01-25,2022-11,2022-11-30,2022-09-23,ACTUAL,2022-09-23,2022-08-01,ACTUAL,2022-08-01,,INTERVENTIONAL,,,A Clinical Trial of PRAX-114 in Participants With Post-Traumatic Stress Disorder,"A Phase 2, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of PRAX-114 in Participants With Post-Traumatic Stress Disorder",TERMINATED,,PHASE2,11.0,ACTUAL,Praxis Precision Medicines,,3.0,,No longer developing for this indication,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,INDUSTRY,,,,,,,2022,0.0
NCT05556356,,2022-09-22,,,2024-10-01,2022-09-22,2022-09-27,ACTUAL,,,,,,,2024-10-01,2024-10-08,ACTUAL,2022-09-13,ACTUAL,2022-09-13,2024-10,2024-10-31,2024-05-06,ACTUAL,2024-05-06,2024-05-06,ACTUAL,2024-05-06,,INTERVENTIONAL,,,Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis,Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis,TERMINATED,,PHASE4,23.0,ACTUAL,Indiana Hand to Shoulder Center,,2.0,,Physician decision,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,OTHER,,,,,,,2024,0.0
NCT04888585,,2021-05-13,2024-08-19,2023-07-14,2024-09-30,2021-05-13,2021-05-17,ACTUAL,2024-09-30,2024-10-08,ACTUAL,,2024-10-08,ACTUAL,2024-09-30,2024-10-08,ACTUAL,2021-06-23,ACTUAL,2021-06-23,2024-09,2024-09-30,2023-08-04,ACTUAL,2023-08-04,2022-08-25,ACTUAL,2022-08-25,,INTERVENTIONAL,,"The Intent-to-treat (ITT) Population included all participants who were randomized and received at least 1 dose of study drug (N=472). The ITT Population was used for all efficacy analyses.~The Placebo group from Period 1 was re-randomized to either 150 mg or 340 mg for the Long-Term Extension Periods 1 and 2. For the other groups from Period 1 receiving ABBV-154, participants continued receiving ABBV-154 at the same dose and dosing regimen as in Period 1.",Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA),"A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)",TERMINATED,,PHASE2,473.0,ACTUAL,AbbVie,,5.0,,Business decision,f,,,,t,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,INDUSTRY,,,,,,,2023,0.0
NCT03086343,,2017-03-20,2020-05-08,,2024-07-17,2017-03-20,2017-03-22,ACTUAL,2020-05-28,2020-06-04,ACTUAL,,,,2024-07-17,2024-07-18,ACTUAL,2017-05-09,ACTUAL,2017-05-09,2024-07,2024-07-31,2023-06-06,ACTUAL,2023-06-06,2019-06-13,ACTUAL,2019-06-13,,INTERVENTIONAL,,Full Analysis Set: all randomized participants who received at least one dose of study drug during Period 1,A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs,"A Phase 3, Randomized, Active-Controlled, Double-Blind Study Comparing Upadacitinib (ABT-494) to Abatacept in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)",COMPLETED,,PHASE3,657.0,ACTUAL,AbbVie,,4.0,,,f,,,,t,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,INDUSTRY,,,,,,,2023,1.0
NCT04379492,,2020-05-05,,,2020-10-29,2020-05-06,2020-05-07,ACTUAL,,,,,,,2020-10-29,2020-10-30,ACTUAL,2020-05-05,ACTUAL,2020-05-05,2020-10,2020-10-31,2020-09-25,ACTUAL,2020-09-25,2020-09-25,ACTUAL,2020-09-25,,INTERVENTIONAL,,,A Study of Hydroxycholoroquine Compared to Placebo as Treatment for People With COVID-19,"Single-center, Phase II, Randomized Double-blind, Placebo-controlled Study of Hydroxychloroquine Compared to Placebo as Treatment for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection",WITHDRAWN,,PHASE2,0.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,2.0,,Emerging evidence does not support the use of HCQ for treatment or prevention of SARS -CoV2 infection. No pts have been enrolled.,f,,,,,t,f,,,,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,OTHER,,,,,,,2020,0.0
NCT04749433,,2021-01-29,,,2024-10-03,2021-02-08,2021-02-11,ACTUAL,,,,,,,2024-10-03,2024-10-08,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2024-10,2024-10-31,2023-03-30,ACTUAL,2023-03-30,2023-03-30,ACTUAL,2023-03-30,,INTERVENTIONAL,,,Study of [11C]CPPC to Assess the Safety and Tolerability in Patients With ALS,A Phase 1 Study to Assess the Safety and Tolerability of PET Imaging With [11C]CPPC [5-cyano-N-(4-(4-[11C]Methylpiperazin-1-yl)-2-(Piperidin-1-yl)Phenyl)Furan-2-carboxamide] Radioligand in Patients With Amyotrophic Lateral Sclerosis,TERMINATED,,PHASE1,4.0,ACTUAL,Johns Hopkins University,,2.0,,study stopped to enhance protocol and resume under different sponsor,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,OTHER,,,,,,,2023,0.0
NCT04924413,,2021-05-31,,,2024-07-02,2021-06-09,2021-06-14,ACTUAL,,,,,,,2024-07-02,2024-07-03,ACTUAL,2021-07-01,ACTUAL,2021-07-01,2024-07,2024-07-31,2024-07-02,ACTUAL,2024-07-02,2024-07-02,ACTUAL,2024-07-02,,INTERVENTIONAL,,,L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma,L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma,TERMINATED,,PHASE2,9.0,ACTUAL,Henan Cancer Hospital,,1.0,,Slow enrollment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,OTHER_GOV,,,,,,,2024,0.0
NCT00281658,,2006-01-23,2011-05-05,,2023-02-09,2006-01-24,2006-01-25,ESTIMATED,2011-05-05,2011-06-01,ESTIMATED,,,,2023-02-09,2023-02-10,ACTUAL,2006-01-02,ACTUAL,2006-01-02,2023-02,2023-02-28,2021-11-23,ACTUAL,2021-11-23,2010-06-18,ACTUAL,2010-06-18,,INTERVENTIONAL,,,Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2,"A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Study of Lapatinib (GW572016) in Combination With Paclitaxel Versus Paclitaxel Plus Placebo in Subjects With ErbB2 Amplified Metastatic Breast Cancer",COMPLETED,,PHASE3,444.0,ACTUAL,Novartis,The data collected for China patients after 01JUL2019 were excluded from analysis due to local regulations in China.,4.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,INDUSTRY,,,,,,,2021,1.0
NCT04984876,,2021-07-29,2024-05-22,,2024-09-13,2021-07-29,2021-08-02,ACTUAL,2024-09-13,2024-10-08,ACTUAL,,,,2024-09-13,2024-10-08,ACTUAL,2021-12-07,ACTUAL,2021-12-07,2024-09,2024-09-30,2023-11-27,ACTUAL,2023-11-27,2023-11-27,ACTUAL,2023-11-27,,INTERVENTIONAL,,,Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy,"A 52 Week, Multi-center, Randomized, Double-blind Placebo-controlled Study to Assess the Clinical Efficacy and Safety of Ligelizumab (QGE031) in Decreasing the Sensitivity to Peanuts in Patients With Peanut Allergy",TERMINATED,,PHASE3,211.0,ACTUAL,Novartis,,5.0,,Study terminated by sponsor,,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,INDUSTRY,,,,,,,2023,0.0
NCT05269121,,2022-02-25,,,2024-02-21,2022-02-25,2022-03-07,ACTUAL,,,,,,,2024-02-21,2024-02-22,ACTUAL,2022-09,ESTIMATED,2022-09-30,2024-02,2024-02-29,2024-11,ESTIMATED,2024-11-30,2023-11,ESTIMATED,2023-11-30,,INTERVENTIONAL,ACTIVE1,,Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections,"An Open-Label Multicenter Study to Evaluate the Safety and Efficacy of PhageBank™ Phage Therapy in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) for Patients With First Time Culture Proven Chronic Prosthetic Joint Infection",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Adaptive Phage Therapeutics, Inc.",,1.0,,Sponsor Decision,,,,,t,t,f,,,,,,,,,,,2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,INDUSTRY,,,,,,,2024,0.0
NCT02767921,,2016-05-06,,,2021-11-15,2016-05-06,2016-05-11,ESTIMATED,,,,,,,2021-11-15,2021-11-24,ACTUAL,2016-08-02,ACTUAL,2016-08-02,2021-11,2021-11-30,2021-11-15,ACTUAL,2021-11-15,2020-01-28,ACTUAL,2020-01-28,,INTERVENTIONAL,,,"sEphB4-HSA Before Surgery in Treating Patients With Bladder Cancer, Prostate Cancer, or Kidney Cancer",A Pilot Study of Neoadjuvant sEphB4-HSA in Patients With Genitourinary Cancers,TERMINATED,,PHASE1,2.0,ACTUAL,University of Southern California,,1.0,,Insufficient accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,OTHER,,,,,,,2021,0.0
NCT03772288,,2018-12-10,,,2023-02-06,2018-12-10,2018-12-11,ACTUAL,,,,,,,2023-02-06,2023-02-08,ACTUAL,2019-04-03,ACTUAL,2019-04-03,2023-02,2023-02-28,2021-11-17,ESTIMATED,2021-11-17,2021-11-10,ESTIMATED,2021-11-10,,INTERVENTIONAL,,,A Study of TAK-659 in Combination With NKTR-214 in Participants With Advanced Non-Hodgkin Lymphoma (NHL),A Phase 1b Study of TAK-659 in Combination With NKTR-214 in Patients With Advanced Non-Hodgkin Lymphoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,"Calithera Biosciences, Inc",,2.0,,Business Decision: No Safety or Efficacy Concerns,f,,,,f,t,f,,,,,,,,,YES,"Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,INDUSTRY,,,,,,,2021,0.0
NCT04886596,,2021-04-29,2023-04-10,,2024-09-20,2021-05-10,2021-05-14,ACTUAL,2023-07-14,2023-08-04,ACTUAL,,,,2024-09-20,2024-10-08,ACTUAL,2021-05-25,ACTUAL,2021-05-25,2024-09,2024-09-30,2024-05-31,ACTUAL,2024-05-31,2022-04-11,ACTUAL,2022-04-11,,INTERVENTIONAL,,,Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above,"A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above",COMPLETED,,PHASE3,26668.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,INDUSTRY,,,,,,,2024,1.0
NCT04172844,,2019-11-20,,,2024-05-31,2019-11-20,2019-11-21,ACTUAL,,,,,,,2024-05-31,2024-06-04,ACTUAL,2020-01-13,ACTUAL,2020-01-13,2024-05,2024-05-31,2022-02-27,ACTUAL,2022-02-27,2021-12-12,ACTUAL,2021-12-12,,INTERVENTIONAL,PAVE,,"Pevonedistat, Azacitidine (or Decitabine), and Venetoclax for the Treatment of Patients With Acute Myelogenous Leukemia","A Multisite Phase Ib Study of Pevonedistat, Azacitidine (or Decitabine), and Venetoclax (PAVE) for the Treatment of Patients With Acute Myelogenous Leukemia (AML)",TERMINATED,,PHASE1,16.0,ACTUAL,Medical College of Wisconsin,,2.0,,Takeda P3001 study didn't meet primary endpoint of improvement in event-free survival. There is no regulatory path forward for pevonedistat.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,OTHER,,,,,,,2022,0.0
NCT03677401,,2018-09-17,2020-10-06,,2021-05-18,2018-09-17,2018-09-19,ACTUAL,2020-10-06,2020-10-28,ACTUAL,,,,2021-05-18,2021-05-20,ACTUAL,2018-08-29,ACTUAL,2018-08-29,2021-05,2021-05-31,2020-02-06,ACTUAL,2020-02-06,2020-01-09,ACTUAL,2020-01-09,,INTERVENTIONAL,,,"Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis","A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus in Adults With Prurigo Nodularis",COMPLETED,,PHASE3,295.0,ACTUAL,Vyne Therapeutics Inc.,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,INDUSTRY,,,,,,,2020,1.0
NCT05457491,,2022-07-11,2023-01-05,,2024-09-24,2022-07-11,2022-07-14,ACTUAL,2024-09-24,2024-10-04,ACTUAL,,,,2024-09-24,2024-10-04,ACTUAL,2021-10-01,ACTUAL,2021-10-01,2024-09,2024-09-30,2022-07-07,ACTUAL,2022-07-07,2022-07-07,ACTUAL,2022-07-07,,INTERVENTIONAL,,,Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE),Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE),TERMINATED,,PHASE1,56.0,ACTUAL,Mayo Clinic,Study was terminated early per Principal Investigator,1.0,,Principal Investigator discretion,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,OTHER,,,,,,,2022,0.0
NCT02451943,,2015-05-20,2019-11-27,,2024-09-20,2015-05-20,2015-05-22,ESTIMATED,2019-11-27,2019-12-17,ACTUAL,,,,2024-09-20,2024-10-08,ACTUAL,2015-09-14,ACTUAL,2015-09-14,2024-09,2024-09-30,2024-06-27,ACTUAL,2024-06-27,2018-12-05,ACTUAL,2018-12-05,,INTERVENTIONAL,ANNOUNCE,All randomized participants.,A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma,"A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin Plus Olaratumab Versus Doxorubicin Plus Placebo in Patients With Advanced or Metastatic Soft Tissue Sarcoma",COMPLETED,,PHASE3,509.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,,,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,INDUSTRY,,,,,,,2024,1.0
NCT04672954,,2020-12-14,2023-07-31,,2023-07-31,2020-12-14,2020-12-17,ACTUAL,2023-07-31,2024-03-08,ACTUAL,,,,2023-07-31,2024-03-08,ACTUAL,2021-01-07,ACTUAL,2021-01-07,2023-07,2023-07-31,2021-07-01,ACTUAL,2021-07-01,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,,Treated set (TS): all subjects who were entered and treated with one dose of study drug (i.e. verum or placebo).,A Study in Healthy Men to Test How Different Doses of BI 474121 Are Taken up and How They Influence the Amount of a Molecular Messenger (cGMP) in the Spinal Fluid,Pharmacokinetics and Pharmacodynamic Effects of Different Single Oral Doses of BI 474121 in Healthy Male Subjects,COMPLETED,,PHASE1,24.0,ACTUAL,Boehringer Ingelheim,,5.0,,,f,,,,f,f,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,INDUSTRY,,,,,,,2021,1.0
NCT03797872,,2018-12-18,2021-02-15,,2021-05-07,2019-01-04,2019-01-09,ACTUAL,2021-05-07,2021-05-10,ACTUAL,,,,2021-05-07,2021-05-10,ACTUAL,2019-04-17,ACTUAL,2019-04-17,2020-03,2020-03-31,2020-07-16,ACTUAL,2020-07-16,2020-07-16,ACTUAL,2020-07-16,,INTERVENTIONAL,POISE,Only one participant was included,Psoriatic Oligoarthritis Intervention With Symptomatic thErapy,Clinical Effectiveness of Symptomatic Therapy Compared to Standard Step up Care for the Treatment of Low Impact Psoriatic Oligoarthritis: a 2 Arm Parallel Group Feasibility Study,COMPLETED,,PHASE4,1.0,ACTUAL,University of Oxford,Only 1 participants was eligible and participated in the trial during the recruitment period and this patient was lost to follow up after the baseline visit.,2.0,,,f,,,,t,f,f,,,f,,,,,,UNDECIDED,Undecided,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,OTHER,,,,,,,2020,0.0
NCT04605614,,2020-10-22,,,2022-06-07,2020-10-22,2020-10-28,ACTUAL,,,,,,,2022-06-07,2022-06-09,ACTUAL,2022-08-15,ESTIMATED,2022-08-15,2022-06,2022-06-30,2024-10-30,ESTIMATED,2024-10-30,2024-10-30,ESTIMATED,2024-10-30,,INTERVENTIONAL,,,64Cu-DOTA-pembrolizumab PET for the Study of PD1 Expression,A Phase I Study of 64Cu Pembrolizumab PET Imaging for In Vivo Expression of PD1,WITHDRAWN,,PHASE1,0.0,ACTUAL,City of Hope Medical Center,,1.0,,slow accruals,,,,,,t,f,,,f,,,,,,,,2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,OTHER,,,,,,,2024,0.0
NCT02323100,,2014-12-18,,,2022-03-04,2014-12-18,2014-12-23,ESTIMATED,,,,,,,2022-03-04,2022-03-21,ACTUAL,2018-12-02,ACTUAL,2018-12-02,2022-03,2022-03-31,2022-03-01,ACTUAL,2022-03-01,2022-03-01,ACTUAL,2022-03-01,,INTERVENTIONAL,GPBA,,Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis),"A Double Blind, Placebo Controlled, Dose Escalation Trial of Glycerol Phenylbutyrate Corrector Therapy for Cystic Fibrosis",TERMINATED,,PHASE1/PHASE2,13.0,ACTUAL,National Jewish Health,,3.0,,funding ended,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,OTHER,,,,,,,2022,0.0
NCT02589600,,2015-10-27,2023-06-16,,2023-09-15,2015-10-27,2015-10-28,ESTIMATED,2023-07-25,2023-08-16,ACTUAL,,,,2023-09-15,2023-09-26,ACTUAL,2016-01,ACTUAL,2016-01-31,2023-09,2023-09-30,2022-06-22,ACTUAL,2022-06-22,2022-06-22,ACTUAL,2022-06-22,,INTERVENTIONAL,ZEST II,Same as participant flow,Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II),ZEST II for Osteoporotic Fracture Prevention,COMPLETED,,PHASE4,310.0,ACTUAL,University of Pittsburgh,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,OTHER,,,,,,,2022,1.0
NCT03279289,,2017-08-03,,,2023-04-12,2017-09-08,2017-09-12,ACTUAL,,,,,,,2023-04-12,2023-04-13,ACTUAL,2017-10-25,ACTUAL,2017-10-25,2023-04,2023-04-30,2023-02-09,ACTUAL,2023-02-09,2023-02-09,ACTUAL,2023-02-09,,INTERVENTIONAL,AFEMA,,"Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Population With mCRC After Failure of an Oxaliplatin-based Regimen","Randomised, Multicentre, Phase II Pilot Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Population With Metastatic Colorectal Cancer (mCRC) After Failure of an Oxaliplatin-based Regimen",COMPLETED,,PHASE2,170.0,ACTUAL,Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD),,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,OTHER,,,,,,,2023,1.0
NCT02122913,,2014-04-16,,,2023-11-02,2014-04-24,2014-04-25,ESTIMATED,,,,,,,2023-11-02,2023-11-07,ACTUAL,2014-05-04,ACTUAL,2014-05-04,2023-11,2023-11-30,2021-04-09,ACTUAL,2021-04-09,2017-02-01,ACTUAL,2017-02-01,,INTERVENTIONAL,,,A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer,A Phase 1 Study of the Oral TRK Inhibitor Larotrectinib in Adult Patients With Solid Tumors,COMPLETED,,PHASE1,75.0,ACTUAL,Bayer,,7.0,,,t,,,,f,t,f,,,,,,,,,UNDECIDED,"Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,INDUSTRY,,NCT03025360,APPROVED_FOR_MARKETING,,,,2021,1.0
NCT03247244,,2017-07-25,,,2021-01-21,2017-08-08,2017-08-11,ACTUAL,,,,,,,2021-01-21,2021-01-25,ACTUAL,2018-01-15,ACTUAL,2018-01-15,2021-01,2021-01-31,2020-01-27,ACTUAL,2020-01-27,2019-06-06,ACTUAL,2019-06-06,,INTERVENTIONAL,,,Safety and Efficacy of Cannabis in Tourette Syndrome,"A Double-blind, Randomized, Placebo-controlled Crossover Pilot Trial of Medical Cannabis in Adults With Tourette Syndrome",TERMINATED,,PHASE2,15.0,ACTUAL,"University Health Network, Toronto",,4.0,,Recruitment/enrollment took too long,f,,,,f,f,f,,,f,,,,,,,,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,OTHER,,,,,,,2020,0.0
NCT03602560,,2018-07-18,2022-03-23,,2022-07-07,2018-07-18,2018-07-27,ACTUAL,2022-05-04,2022-05-31,ACTUAL,,,,2022-07-07,2022-08-02,ACTUAL,2018-10-01,ACTUAL,2018-10-01,2022-07,2022-07-31,2020-02-16,ACTUAL,2020-02-16,2020-02-16,ACTUAL,2020-02-16,,INTERVENTIONAL,,,ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA),"A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)",COMPLETED,,PHASE3,265.0,ACTUAL,Gilead Sciences,,3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,INDUSTRY,,,,,,,2020,1.0
NCT02971033,,2016-10-21,2022-04-06,,2022-05-10,2016-11-18,2016-11-22,ESTIMATED,2022-05-10,2022-06-06,ACTUAL,,,,2022-05-10,2022-06-06,ACTUAL,2018-04-16,ACTUAL,2018-04-16,2022-05,2022-05-31,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,,no patients were randomized to 40mg/day ezetimibe group,Ezetimibe as a Safe and Efficacious Treatment for Chronic Hepatitis C,Ezetimibe as a Safe and Efficacious Treatment for Chronic Hepatitis C,TERMINATED,,PHASE2,2.0,ACTUAL,VA Office of Research and Development,1. A major limitation is that the study was that it was interrupted by the CoVID-19 pandemic and then was terminated early leading to small numbers of subjects analyzed. It is not possible to derive conclusions comparing the single patients enrolled in arms 1 and 2.~2. The patient in arm 2 had study medication remaining at the first pill count indicating that EZE dosing was lower than 20mg/day during at least part of the treatment period.,3.0,,Study Funding ended,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,FED,,,,,,,2021,0.0
NCT03852433,,2019-02-21,2024-06-24,2023-03-24,2024-09-24,2019-02-21,2019-02-25,ACTUAL,2024-07-26,2024-07-29,ACTUAL,,2024-07-29,ACTUAL,2024-09-24,2024-10-08,ACTUAL,2019-05-31,ACTUAL,2019-05-31,2024-09,2024-09-30,2022-09-28,ACTUAL,2022-09-28,2022-04-05,ACTUAL,2022-04-05,,INTERVENTIONAL,,All Randomized Analysis Set included all participants who were enrolled (informed consent signed) and randomized in the study.,Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD),"A Multicenter, Open-label, Randomized Phase 2b Clinical Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Patients With Chronic Hepatitis Delta",COMPLETED,,PHASE2,175.0,ACTUAL,Gilead Sciences,,4.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,INDUSTRY,,,,,,,2022,1.0
NCT03005184,,2016-12-22,,,2018-01-09,2016-12-22,2016-12-29,ESTIMATED,,,,,,,2018-01-09,2018-01-11,ACTUAL,2017-09,ESTIMATED,2017-09-30,2018-01,2018-01-31,2020-01,ESTIMATED,2020-01-31,2020-01,ESTIMATED,2020-01-31,,INTERVENTIONAL,,,Mechanism(s) Underlying Cardiovascular Effects of ARB/NEP Inhibition - Aim 2,Mechanism(s) Underlying Cardiovascular Effects of ARB/NEP Inhibition - Aim 2,WITHDRAWN,,PHASE2,0.0,ACTUAL,Vanderbilt University Medical Center,,12.0,,Study is being redesigned and submitted as a new study.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,OTHER,,,,,,,2020,0.0
NCT03320876,,2017-10-20,,,2022-04-20,2017-10-20,2017-10-25,ACTUAL,,,,,,,2022-04-20,2022-04-21,ACTUAL,2017-07-26,ACTUAL,2017-07-26,2022-04,2022-04-30,2021-06-30,ACTUAL,2021-06-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,,,"An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.","A Multicenter, Open-label, Long-term Extension Safety and Efficacy Study of Filgotinib Treatment in Subjects With Moderately to Severely Active Psoriatic Arthritis.",TERMINATED,,PHASE2,122.0,ACTUAL,Galapagos NV,,1.0,,development program for filgotinib for participants with psoriatic arthritis has been stopped,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,INDUSTRY,,,,,,,2021,0.0
NCT05567952,,2022-10-03,2024-09-17,,2024-09-17,2022-10-03,2022-10-05,ACTUAL,2024-09-17,2024-10-08,ACTUAL,,,,2024-09-17,2024-10-08,ACTUAL,2022-10-19,ACTUAL,2022-10-19,2024-09,2024-09-30,2024-02-09,ACTUAL,2024-02-09,2023-09-27,ACTUAL,2023-09-27,,INTERVENTIONAL,,Full analysis set (FAS) included all participants randomly assigned to study intervention.,A Study to Learn About a Repeat 5-Day Treatment With the Study Medicines (Called Nirmatrelvir/Ritonavir) in People 12 Years Old or Older With Return of COVID-19 Symptoms and SARS-CoV-2 Positivity After Finishing Treatment With Nirmatrelvir/Ritonavir,"AN INTERVENTIONAL, EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE A REPEAT 5-DAY COURSE OF NIRMATRELVIR/RITONAVIR COMPARED TO PLACEBO/RITONAVIR IN PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH REBOUND OF COVID-19 SYMPTOMS AND RAPID ANTIGEN TEST POSITIVITY",COMPLETED,,PHASE2,436.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,INDUSTRY,,,,,,,2024,1.0
NCT05329623,,2022-03-29,,,2024-10-03,2022-04-07,2022-04-15,ACTUAL,,,,,,,2024-10-03,2024-10-08,ACTUAL,2022-05-03,ACTUAL,2022-05-03,2024-10,2024-10-31,2024-04-07,ACTUAL,2024-04-07,2024-04-07,ACTUAL,2024-04-07,,INTERVENTIONAL,,,A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants.,"A Phase 1, Open-label, Single-dose, Multi-center, Parallel Group Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Matched Healthy Control Participants.",TERMINATED,,PHASE1,33.0,ACTUAL,Novartis,,4.0,,Sponsor Decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,INDUSTRY,,,,,,,2024,0.0
NCT02403674,,2015-03-26,2018-02-08,,2024-09-30,2015-03-26,2015-03-31,ESTIMATED,2018-03-28,2018-04-30,ACTUAL,,,,2024-09-30,2024-10-08,ACTUAL,2015-06-05,ACTUAL,2015-06-05,2024-09,2024-09-30,2023-09-07,ACTUAL,2023-09-07,2017-03-20,ACTUAL,2017-03-20,,INTERVENTIONAL,DRIVE-AHEAD,The Baseline Analysis Population consists of all randomized participants who received ≥1 dose of study drug.,"Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021)","A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naïve HIV-1 Infected Subjects",COMPLETED,,PHASE3,734.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,,,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,INDUSTRY,,,,,,,2023,1.0
NCT03822416,,2019-01-28,2021-05-03,,2021-05-03,2019-01-28,2019-01-30,ACTUAL,2021-05-03,2021-05-25,ACTUAL,,,,2021-05-03,2021-05-25,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2021-05,2021-05-31,2020-05-04,ACTUAL,2020-05-04,2020-05-04,ACTUAL,2020-05-04,,INTERVENTIONAL,,,Treating Smokers With Mental Illness,Treating Tobacco Dependence in Smokers With Severe Mental Illness,COMPLETED,,PHASE2,38.0,ACTUAL,University of Minnesota,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,OTHER,,,,,,,2020,1.0
NCT04452006,,2020-06-26,,,2021-07-06,2020-06-26,2020-06-30,ACTUAL,,,,,,,2021-07-06,2021-07-09,ACTUAL,2020-07-20,ACTUAL,2020-07-20,2021-07,2021-07-31,2021-04-20,ACTUAL,2021-04-20,2021-04-20,ACTUAL,2021-04-20,,INTERVENTIONAL,,,"A Study in Healthy Subjects to Investigate the Safety and Tolerability of ACT- 541478 as Well as What ACT-541478 Does to the Body and the Way the Body Takes up, Distributes, and Gets Rid of ACT-541478","Single-center, Double-blind, Randomized, Placebo-controlled, Three-part, First-in-human, Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-541478 in Healthy Subjects",TERMINATED,,PHASE1,56.0,ACTUAL,Idorsia Pharmaceuticals Ltd.,,11.0,,"Based on interim analysis, the Sponsor decided to terminate the study prematurely.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,INDUSTRY,,,,,,,2021,0.0
NCT04927975,,2021-06-11,2024-08-27,2023-12-12,2024-09-30,2021-06-11,2021-06-16,ACTUAL,2024-09-30,2024-10-08,ACTUAL,,2024-10-08,ACTUAL,2024-09-30,2024-10-08,ACTUAL,2021-06-30,ACTUAL,2021-06-30,2024-09,2024-09-30,2023-08-29,ACTUAL,2023-08-29,2023-01-13,ACTUAL,2023-01-13,,INTERVENTIONAL,,"ITT Population in Period 1 (ITT_1): all randomized participants in Period 1, analyzed according to the treatment groups that they were randomized to.",Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Non-Segmental Vitiligo",COMPLETED,,PHASE2,185.0,ACTUAL,AbbVie,,5.0,,,f,,,,t,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,INDUSTRY,,,,,,,2023,1.0
NCT02335944,,2014-10-09,2023-01-10,,2023-05-24,2015-01-07,2015-01-12,ESTIMATED,2023-05-24,2023-06-18,ACTUAL,,,,2023-05-24,2023-06-18,ACTUAL,2015-01-13,ACTUAL,2015-01-13,2023-05,2023-05-31,2020-11-10,ACTUAL,2020-11-10,2020-11-10,ACTUAL,2020-11-10,,INTERVENTIONAL,,No participants were enrolled in Phase II-Group 5 arm due to early study termination.,Study of Safety and Efficacy of EGFR-TKI EGF816 in Combination With cMET Inhibitor INC280 in Adult Patients With EGFR Mutated Non Small Cell Lung Cancer.,"A Phase Ib/II, Multicenter, Open-label Study of EGF816 in Combination With INC280 in Adult Patients With EGFR Mutated Non-small Cell Lung Cancer.",TERMINATED,,PHASE1/PHASE2,177.0,ACTUAL,Novartis,,6.0,,Company decision,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,INDUSTRY,,,,,,,2020,0.0
NCT06102174,,2023-10-06,,,2024-10-03,2023-10-20,2023-10-26,ACTUAL,,,,,,,2024-10-03,2024-10-08,ACTUAL,2024-02-15,ACTUAL,2024-02-15,2024-10,2024-10-31,2024-09-03,ACTUAL,2024-09-03,2024-09-03,ACTUAL,2024-09-03,,INTERVENTIONAL,,,A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV,"AN INTERVENTIONAL, PHASE 1b, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, MULTI-CENTER, DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SISUNATOVIR IN PEDIATRIC PARTICIPANTS UP TO AGE 60 MONTHS WITH RESPIRATORY SYNCYTIAL VIRUS (RSV) LOWER RESPIRATORY TRACT INFECTION (LRTI)",TERMINATED,,PHASE1,10.0,ACTUAL,Pfizer,,2.0,,Study discontinued due to business reasons. There were no safety concerns in the decision to stop study and no changes to sponsor's assessment of the risk-benefit profile for participants who received sisunatovir in the study,f,,,,t,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,INDUSTRY,,,,,,,2024,0.0
NCT03361345,,2017-11-17,,,2023-05-12,2017-12-01,2017-12-04,ACTUAL,,,,,,,2023-05-12,2023-05-16,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2023-05,2023-05-31,2022-01-09,ACTUAL,2022-01-09,2022-01-09,ACTUAL,2022-01-09,,INTERVENTIONAL,,,Topical 5% Tranexamic Acid as a Treatment for Postinflammatory Hyperpigmentation Due to Acne Vulgaris,Topical 5% Tranexamic Acid as a Treatment for Postinflammatory Hyperpigmentation Due to Acne Vulgaris,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Wayne State University,,2.0,,Lack of recruitment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,OTHER,,,,,,,2022,0.0
NCT04816526,,2021-03-23,2024-06-27,,2024-09-30,2021-03-23,2021-03-25,ACTUAL,2024-09-30,2024-10-08,ACTUAL,,,,2024-09-30,2024-10-08,ACTUAL,2021-12-01,ACTUAL,2021-12-01,2024-09,2024-09-30,2022-11-03,ACTUAL,2022-11-03,2022-08-04,ACTUAL,2022-08-04,,INTERVENTIONAL,,,Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy,Phase 2 Study of Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy,TERMINATED,,PHASE2,13.0,ACTUAL,Cartesian Therapeutics,,1.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,,,2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,INDUSTRY,,,,,,,2022,0.0
NCT04830462,,2021-03-31,,,2023-05-15,2021-03-31,2021-04-05,ACTUAL,,,,,,,2023-05-15,2023-05-16,ACTUAL,2021-04-15,ACTUAL,2021-04-15,2023-05,2023-05-31,2023-05-01,ACTUAL,2023-05-01,2023-05-01,ACTUAL,2023-05-01,,INTERVENTIONAL,,,Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation,Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation,COMPLETED,,PHASE4,32.0,ACTUAL,Herlev and Gentofte Hospital,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,OTHER,,,,,,,2023,1.0
NCT04700787,,2021-01-06,,,2022-06-09,2021-01-06,2021-01-08,ACTUAL,,,,,,,2022-06-09,2022-06-13,ACTUAL,2021-04-30,ACTUAL,2021-04-30,2022-06,2022-06-30,2022-04-04,ACTUAL,2022-04-04,2022-03-25,ACTUAL,2022-03-25,,INTERVENTIONAL,,,"Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents","A Phase 1, Multi-Center, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Sulopenem and Sulopenem Etzadroxil + Probenecid in Adolescent Patients With Bacterial Infection",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Iterum Therapeutics, International Limited",,1.0,,Enrollment challenges and change in development plan necessitating a change in study design,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,INDUSTRY,,,,,,,2022,0.0
NCT02729714,,2016-01-26,2024-06-11,,2024-07-25,2016-04-05,2016-04-06,ESTIMATED,2024-07-25,2024-08-20,ACTUAL,,,,2024-07-25,2024-08-20,ACTUAL,2016-04,ACTUAL,2016-04-30,2024-07,2024-07-31,2022-04,ACTUAL,2022-04-30,2022-04,ACTUAL,2022-04-30,,INTERVENTIONAL,,,A Pilot Study of Suvorexant for Insomnia in Parkinson Disease,"A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Suvorexant for Insomnia in Parkinson Disease",COMPLETED,,PHASE4,21.0,ACTUAL,"Burdick, Daniel, M.D.","Designed as a pilot study, so recruitment goal was low and consequently the sample size is small, limiting interpretation of the significance of the differences between suvorexant and placebo.",2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,INDIV,,,,,,,2022,1.0
NCT05900648,,2023-05-31,,,2024-04-26,2023-05-31,2023-06-12,ACTUAL,,,,,,,2024-04-26,2024-04-29,ACTUAL,2023-05-17,ACTUAL,2023-05-17,2024-04,2024-04-30,2024-02-09,ACTUAL,2024-02-09,2024-02-09,ACTUAL,2024-02-09,,INTERVENTIONAL,,,Regorafenib and XmAb20717 in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy (RX-CROME),Regorafenib and XmAb20717 in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy (RX-CROME),WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,0 participant accrual,,,,,t,t,f,,,,,,,,,,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,OTHER,,,,,,,2024,0.0
NCT02464657,,2015-06-03,2021-06-08,,2021-09-09,2015-06-04,2015-06-08,ESTIMATED,2021-09-09,2021-10-07,ACTUAL,,,,2021-09-09,2021-10-07,ACTUAL,2015-07,ACTUAL,2015-07-31,2021-09,2021-09-30,2020-05-07,ACTUAL,2020-05-07,2020-05-07,ACTUAL,2020-05-07,,INTERVENTIONAL,,,"Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)","Phase I/II Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)",COMPLETED,,PHASE1/PHASE2,44.0,ACTUAL,M.D. Anderson Cancer Center,,3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,OTHER,,,,,,,2020,1.0
NCT03498391,,2018-03-12,,,2023-02-06,2018-04-06,2018-04-13,ACTUAL,,,,,,,2023-02-06,2023-02-08,ACTUAL,2018-07-30,ACTUAL,2018-07-30,2023-02,2023-02-28,2023-05,ESTIMATED,2023-05-31,2023-05,ESTIMATED,2023-05-31,,INTERVENTIONAL,MSI,,A Study of Human Multi-Sensory Integration,A Study of Human Multi-Sensory Integration: A Neurophysiologic Correlate of Conscious Perception,SUSPENDED,,PHASE2,40.0,ESTIMATED,University of Pennsylvania,,2.0,,Due to the impact of COVID-19,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,OTHER,,,,,,,2023,0.0
NCT03996369,,2019-06-21,2022-11-28,,2022-11-28,2019-06-21,2019-06-24,ACTUAL,2022-11-28,2022-12-21,ACTUAL,,,,2022-11-28,2022-12-21,ACTUAL,2020-09-15,ACTUAL,2020-09-15,2022-01,2022-01-31,2021-12-07,ACTUAL,2021-12-07,2021-12-07,ACTUAL,2021-12-07,,INTERVENTIONAL,ELEVATE UC 12,Full Analysis Set: All randomized participants who received at least 1 dose of study intervention.,Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis",COMPLETED,,PHASE3,354.0,ACTUAL,Arena Pharmaceuticals,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,INDUSTRY,,,,,,,2021,1.0
NCT04267276,,2020-02-11,2021-12-17,,2022-05-05,2020-02-11,2020-02-12,ACTUAL,2021-12-17,2022-02-23,ACTUAL,,,,2022-05-05,2022-06-01,ACTUAL,2020-02-18,ACTUAL,2020-02-18,2022-05,2022-05-31,2020-04-02,ACTUAL,2020-04-02,2020-04-02,ACTUAL,2020-04-02,,INTERVENTIONAL,,Treated set (TS): The treated set includes all participants who were entered and treated with one dose of trial drug. The treated set will be used for safety analyses.,A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body,"Investigation of Metabolism and Pharmacokinetics of BI 1265162 (C-14) After Intravenous Administration (Part 1) and Investigation of Metabolism and Pharmacokinetics of BI 1265162 (C-14) After Oral Administration (Part 2) in Healthy Male Subjects Following a Non-randomized, Open-label, Single-dose, Single Arm Per Trial Part Mass Balance Design",TERMINATED,,PHASE1,7.0,ACTUAL,Boehringer Ingelheim,"The study was interrupted due to COVID-19 crisis on 02-Apr-2020, after completion of Part 1. Further, the sponsor decided to discontinue the development of BI 1265162. Enrolment in Part 2 (oral administration of BI 1265162 (C-14)) did not take place. Decision to terminate trial was taken on 17-Dec-2020.",2.0,,"Due to the COVID-19 pandemic, the recruitment of new subjects was temporarily halted in March 2020. The study was permanently discontinued in December 2020.",f,,,,f,f,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: http://trials.boehringer-ingelheim.com/",2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,INDUSTRY,,,,,,,2020,0.0
NCT02700841,,2016-03-02,2024-01-29,,2024-03-08,2016-03-02,2016-03-07,ESTIMATED,2024-03-08,2024-03-12,ACTUAL,,,,2024-03-08,2024-03-12,ACTUAL,2020-01-09,ACTUAL,2020-01-09,2024-03,2024-03-31,2022-12-21,ACTUAL,2022-12-21,2022-12-21,ACTUAL,2022-12-21,,INTERVENTIONAL,,,Enhancing Anti--Tetanus Vaccine Response After Autologous Stem Cell Transplantation,A Phase II Study of Enhancing Anti-Tetanus Vaccine Response After Autologous Stem Cell Transplantation,TERMINATED,,PHASE2,8.0,ACTUAL,University of Nebraska,,2.0,,Study terminated prematurely due to poor recruitment.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,OTHER,,,,,,,2022,0.0
NCT02594111,,2015-10-30,2020-06-08,,2023-01-25,2015-10-30,2015-11-01,ESTIMATED,2020-06-26,2020-07-10,ACTUAL,,,,2023-01-25,2023-02-21,ACTUAL,2013-05-30,ACTUAL,2013-05-30,2023-01,2023-01-31,2021-12-31,ACTUAL,2021-12-31,2019-08-30,ACTUAL,2019-08-30,,INTERVENTIONAL,Colchicine-PCI,,Colchicine in Percutaneous Coronary Intervention,Anti-inflammatory Therapy During Percutaneous Coronary Intervention,COMPLETED,,PHASE4,714.0,ACTUAL,VA Office of Research and Development,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,FED,,,,,,,2021,1.0
NCT05512949,,2022-08-20,2023-11-30,2023-10-25,2024-10-03,2022-08-20,2022-08-23,ACTUAL,2024-01-08,2024-01-09,ACTUAL,,2024-01-09,ACTUAL,2024-10-03,2024-10-08,ACTUAL,2022-09-09,ACTUAL,2022-09-09,2022-08-23,2022-08-23,2023-10-19,ACTUAL,2023-10-19,2022-12-01,ACTUAL,2022-12-01,,INTERVENTIONAL,,,Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine,"A Phase 2 Randomized, Open-Label, Multisite Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Vaccine",COMPLETED,,PHASE2,229.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,3.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,NIH,,,,,,,2023,1.0
NCT03345797,,2017-10-10,,,2023-10-24,2017-11-14,2017-11-17,ACTUAL,,,,,,,2023-10-24,2023-10-26,ACTUAL,2018-03-01,ACTUAL,2018-03-01,2023-10,2023-10-31,2022-04-11,ACTUAL,2022-04-11,2020-04-11,ACTUAL,2020-04-11,,INTERVENTIONAL,,,Evaluation of Testosterone Nasal Gel in Hypogonadal Boys,"A Multicenter, Open Label, Variable Dose, Two Arm Pilot Paediatric Phase 1 PK Study to Evaluate Testosterone Nasal Gel (4.5% w/w) in Hypogonadal Boys",TERMINATED,,PHASE1,8.0,ACTUAL,Acerus Pharmaceuticals Corporation,,2.0,,Lack of patients and commercial reasons,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,INDUSTRY,,,,,,,2022,0.0
NCT04890353,,2021-05-11,,,2023-10-24,2021-05-17,2021-05-18,ACTUAL,,,,,,,2023-10-24,2023-10-25,ACTUAL,2021-12-01,ACTUAL,2021-12-01,2021-05,2021-05-31,2023-02-28,ACTUAL,2023-02-28,2023-02-08,ACTUAL,2023-02-08,,INTERVENTIONAL,,,Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke,Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke,TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,"Xuanwu Hospital, Beijing",,2.0,,The interim analysis of another associated study is not very effective,f,,,,,f,f,,,,,,,,,,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,OTHER,,,,,,,2023,0.0
NCT03990974,,2019-06-18,,,2020-03-23,2019-06-18,2019-06-19,ACTUAL,,,,,,,2020-03-23,2020-03-25,ACTUAL,2020-09,ESTIMATED,2020-09-30,2020-03,2020-03-31,2021-07,ESTIMATED,2021-07-31,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,HCC,,Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in HCC After Liver Resection,"Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in Hepatocellular Carcinoma After Liver Resection: A Multi-center, Randomized, Open-labelled Trial.",SUSPENDED,,PHASE3,458.0,ESTIMATED,Sun Yat-sen University,,2.0,,There were difficulties in implementation,f,,,,t,f,f,,,,,,,,,,,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,OTHER,,,,,,,2021,0.0
NCT02819518,,2016-06-28,2022-06-08,,2023-11-06,2016-06-28,2016-06-30,ESTIMATED,2022-06-08,2022-07-05,ACTUAL,,,,2023-11-06,2023-11-09,ACTUAL,2016-07-27,ACTUAL,2016-07-27,2023-11,2023-11-30,2023-10-30,ACTUAL,2023-10-30,2021-06-15,ACTUAL,2021-06-15,,INTERVENTIONAL,,,Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355),"A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355)",COMPLETED,,PHASE3,882.0,ACTUAL,Merck Sharp & Dohme LLC,,5.0,,,f,,,,t,,,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,INDUSTRY,,,,,,,2023,1.0
NCT02756663,,2016-04-12,,,2016-11-07,2016-04-26,2016-04-29,ESTIMATED,,,,,,,2016-11-07,2016-11-08,ESTIMATED,2016-12,,2016-12-31,2016-11,2016-11-30,2021-02,ESTIMATED,2021-02-28,2021-02,ESTIMATED,2021-02-28,,INTERVENTIONAL,PANORAMA-5,,Panobinostat in Combination With Carfilzomib and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma,"A Randomized, Triple-arm, Controlled, Open-label, Multicenter Phase II Study Assessing Two Different Doses of Panobinostat in Combination With Carfilzomib and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma",WITHDRAWN,,PHASE2,0.0,ACTUAL,Novartis,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,INDUSTRY,,,,,,,2021,0.0
NCT05506930,,2022-08-12,,,2024-10-03,2022-08-17,2022-08-18,ACTUAL,,,,,,,2024-10-03,2024-10-08,ACTUAL,2022-08-17,ACTUAL,2022-08-17,2024-10,2024-10-31,2024-05-10,ACTUAL,2024-05-10,2024-05-09,ACTUAL,2024-05-09,,INTERVENTIONAL,,,ITM vs QL for Pediatric Open Lower Abdominal Procedures,Intrathecal Morphine Versus Bilateral Quadratus Lumborum Blocks for Perioperative Analgesia in Pediatric Patients Undergoing Open Lower Abdominal Procedures: A Prospective Randomized Trial,TERMINATED,,PHASE4,14.0,ACTUAL,Medical University of South Carolina,,2.0,,The study was stopped early based on the anecdotal evidence from a surgeon who felt one group was experiencing more side effects than the other. Exposing pediatric patients who would be assigned to the inferior arm was difficult to justify ethically.,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,OTHER,,,,,,,2024,0.0
NCT04473950,,2020-06-12,,,2022-10-06,2020-07-13,2020-07-16,ACTUAL,,,,,,,2022-10-06,2022-10-10,ACTUAL,2020-01-08,ACTUAL,2020-01-08,2022-10,2022-10-31,2022-10-06,ACTUAL,2022-10-06,2022-10-06,ACTUAL,2022-10-06,,INTERVENTIONAL,,,The Effect of Chronic Pain on Delay Discounting in Methadone Patients,The Effect of Chronic Pain on Delay Discounting in Methadone Patients,TERMINATED,,PHASE1,29.0,ACTUAL,"University of California, San Francisco",,2.0,,The COVID-19 Pandemic prevented us from meeting target goals.,f,,,,f,t,f,,,f,,,Data will become available after publication of the main study results.,,,YES,"Data will be made available to the public through presentation at scientific meetings and research publications in peer-reviewed journals. I have routinely kept an open policy to share data with the scientific and medical community upon request, and this policy will be continued with the present project.",2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,OTHER,,,,,,,2022,0.0
NCT02334722,,2015-01-06,2021-10-05,,2021-12-14,2015-01-06,2015-01-08,ESTIMATED,2021-12-14,2021-12-15,ACTUAL,,,,2021-12-14,2021-12-15,ACTUAL,2015-08-05,ACTUAL,2015-08-05,2021-12,2021-12-31,2020-10-07,ACTUAL,2020-10-07,2020-10-07,ACTUAL,2020-10-07,,INTERVENTIONAL,,"Subjects were screened against eligibility criteria. Subjects with a history of seizures, depression or use of psychiatric medications, Beck-Depression Inventory score over 14, biopsy only or other factors were determined ineligible. Potential participants who may have been eligible also declined participation.",1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients,A Shortened Antiepileptic Drug (AED) Course in Surgical Brain Tumor Patients: A Randomized Trial,COMPLETED,,PHASE4,81.0,ACTUAL,University of Florida,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,OTHER,,,,,,,2020,1.0
NCT01891994,,2013-06-28,2018-11-14,,2023-04-03,2013-06-28,2013-07-03,ESTIMATED,2018-11-14,2018-12-04,ACTUAL,,,,2023-04-03,2023-04-25,ACTUAL,2013-06-28,,2013-06-28,2023-03,2023-03-31,2022-08-24,ACTUAL,2022-08-24,2017-10-16,ACTUAL,2017-10-16,,INTERVENTIONAL,,,Extended Dosing With Eltrombopag for Severe Aplastic Anemia,Extended Dosing With Eltrombopag in Refractory Severe Aplastic Anemia,COMPLETED,,PHASE2,40.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,NIH,,,,,,,2022,1.0
NCT03736785,,2018-11-02,2021-02-12,,2021-02-12,2018-11-08,2018-11-09,ACTUAL,2021-02-12,2021-03-08,ACTUAL,,,,2021-02-12,2021-03-08,ACTUAL,2018-11-15,ACTUAL,2018-11-15,2020-03,2020-03-31,2020-02-18,ACTUAL,2020-02-18,2020-02-18,ACTUAL,2020-02-18,,INTERVENTIONAL,,All randomized participants.,A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus,"A Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin",COMPLETED,,PHASE2,399.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,INDUSTRY,,,,,,,2020,1.0
NCT04430985,,2020-06-08,,,2021-10-19,2020-06-11,2020-06-16,ACTUAL,,,,,,,2021-10-19,2021-10-27,ACTUAL,2020-09-30,ACTUAL,2020-09-30,2021-10,2021-10-31,2021-09-06,ACTUAL,2021-09-06,2021-09-06,ACTUAL,2021-09-06,,INTERVENTIONAL,IMMUNOX,,FOLFOX + Immunotherapy With Intrahepatic Oxaliplatin for Patients With Metastatic Colorectal Cancer,FOLFOX + Immunotherapy With Intrahepatic Administration of Oxaliplatin for Patients With Multiple Non-resectable Liver Metastasis From Colorectal Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,Herlev Hospital,,1.0,,Problems identifying eligble patients,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,OTHER,,,,,,,2021,0.0
NCT04011033,,2019-07-03,2021-12-23,,2024-09-28,2019-07-05,2019-07-08,ACTUAL,2024-09-28,2024-10-08,ACTUAL,,,,2024-09-28,2024-10-08,ACTUAL,2018-03-01,ACTUAL,2018-03-01,2024-09,2024-09-30,2023-10-01,ACTUAL,2023-10-01,2020-03-01,ACTUAL,2020-03-01,,INTERVENTIONAL,,,Study of Adoptive Transfer of iNKT Cells Combined With TAE/TACE to Treat Unresectable HCC,Study of Adoptive Transfer of Invariant Natural Killer T Cells Combined With TAE/TACE to Treat Unresectable Hepatocellular Carcinoma (HCC): Phase II Clinical Trial,COMPLETED,,PHASE2,60.0,ACTUAL,Beijing YouAn Hospital,"One limitation of our study is that patients only received two cycles of TAE and the duration of iNKT therapy was only 3 months; thus, our study was not long enough to adequately assess OS. A second limitation was the small sample size, but our promising data prompts future studies in larger cohorts to more thoroughly delineate how iNKT cell therapy can be used in the context of TACE/TAE to improve therapeutic options for patients with unresectable HCC.",2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,OTHER,,,,,,,2023,1.0
NCT05133180,,2021-11-15,2024-03-07,,2024-05-10,2021-11-15,2021-11-24,ACTUAL,2024-05-10,2024-06-07,ACTUAL,,,,2024-05-10,2024-06-07,ACTUAL,2022-01-19,ACTUAL,2022-01-19,2024-05,2024-05-31,2022-12-19,ACTUAL,2022-12-19,2022-09-22,ACTUAL,2022-09-22,,INTERVENTIONAL,,The Full Analysis Set (FAS) population included all patients who were randomized and received at least one dose of the investigational product.,Safety and Efficacy Study on Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PROTEGO-1 Study),"A 4-week, Phase III, Multicenter, Double-masked, Vehicle-controlled Clinical Study to Evaluate Safety and Efficacy of Oxervate® (Cenegermin) 20 mcg/mL Ophthalmic Solution vs Vehicle in Severe Sjogren's Dry Eye Disease",COMPLETED,,PHASE3,104.0,ACTUAL,Dompé Farmaceutici S.p.A,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,INDUSTRY,,,,,,,2022,1.0
NCT04859517,,2021-04-21,2024-04-25,,2024-07-25,2021-04-23,2021-04-26,ACTUAL,2024-07-25,2024-08-20,ACTUAL,,,,2024-07-25,2024-08-20,ACTUAL,2021-04-27,ACTUAL,2021-04-27,2024-04,2024-04-30,2022-11-04,ACTUAL,2022-11-04,2022-11-04,ACTUAL,2022-11-04,,INTERVENTIONAL,EVADE,,Evaluation of ADG20 for the Prevention of COVID-19,"A Phase 2/3 Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Prevention of COVID-19 (EVADE)",TERMINATED,,PHASE2/PHASE3,2582.0,ACTUAL,"Invivyd, Inc.",,2.0,,"All primary efficacy data has been collected and analyzed. Based on the safety data gathered to date, it has been determined that continued participation by study subjects would not yield any additional beneficial safety information.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,INDUSTRY,,,,,,,2022,0.0
NCT03850795,,2019-02-20,,,2024-08-15,2019-02-21,2019-02-22,ACTUAL,,,,,,,2024-08-15,2024-08-19,ACTUAL,2021-03-15,ACTUAL,2021-03-15,2024-08,2024-08-31,2024-06-28,ACTUAL,2024-06-28,2024-06-28,ACTUAL,2024-06-28,,INTERVENTIONAL,,,HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC),"PROCADE: A Multinational Phase 3, Randomized, Double-Blind, Non-inferiority, Efficacy and Safety Study of Oral HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)",TERMINATED,,PHASE3,104.0,ACTUAL,"Hinova Pharmaceuticals USA, Inc.",,2.0,,Terminated by Sponsor for various factors including prolonged duration and enrollment challenges,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,INDUSTRY,,,,,,,2024,0.0
NCT03733444,,2018-11-05,2022-02-16,,2022-07-06,2018-11-05,2018-11-07,ACTUAL,2022-07-06,2022-07-29,ACTUAL,,,,2022-07-06,2022-07-29,ACTUAL,2018-11-05,ACTUAL,2018-11-05,2022-07,2022-07-31,2021-03-30,ACTUAL,2021-03-30,2021-03-30,ACTUAL,2021-03-30,,INTERVENTIONAL,ISABELA2,Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of investigation product (IP).,A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care,"A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis",TERMINATED,,PHASE3,781.0,ACTUAL,Galapagos NV,,3.0,,The benefit-risk profile no longer supports continuing the study,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,INDUSTRY,,,,,,,2021,0.0
NCT04239872,,2020-01-15,2022-03-09,,2023-01-09,2020-01-20,2020-01-27,ACTUAL,2022-06-16,2022-06-21,ACTUAL,,,,2023-01-09,2023-01-31,ACTUAL,2020-03-11,ACTUAL,2020-03-11,2023-01,2023-01-31,2021-04-05,ACTUAL,2021-04-05,2021-04-05,ACTUAL,2021-04-05,,INTERVENTIONAL,,,Fluoride Retention in the Mouth of Older Adults,Optimizing Fluoride Retention in the Mouth of Older Adults With Distinct Salivary Flow Rates,COMPLETED,,PHASE1,20.0,ACTUAL,University of Michigan,The amount of biofilm collected from participants at the different time points was not enough for all the analyses planned in a number of occasions. This accounts for the lack of data for the calcium concentration in the biofilm fluid.~This experiment was conducted during the COVID-19 pandemic.,2.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,OTHER,,,,,,,2021,1.0
NCT02895373,,2016-06-30,,,2022-01-25,2016-09-05,2016-09-09,ESTIMATED,,,,,,,2022-01-25,2022-02-09,ACTUAL,2016-07,ACTUAL,2016-07-31,2022-01,2022-01-31,2021-07,ACTUAL,2021-07-31,2021-05,ACTUAL,2021-05-31,,INTERVENTIONAL,ECMO_PGE1,,PGE1 as Additive Anticoagulant in ECMO-Therapy,"A Prospective Randomized, Double Blind Study on Safety and Efficacy of Alprostadil as Additional Anticoagulant in Patients With Veno- Venous Extracorporeal Membrane Oxygenation (ECMO)",TERMINATED,,PHASE2,50.0,ACTUAL,Medical University of Vienna,,2.0,,After completion of pilot study (n=50) no effect on primary outcome and limited feasibility of recruitment and study procedures,f,,,,f,,,,,,,,,,,NO,"Data will be published in a peer-reviewed journal, individual data will not be made publicly available except by a direct request to the PI (in an anonymized fashion)",2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,OTHER,,,,,,,2021,0.0
NCT04308785,,2020-03-12,,,2023-10-19,2020-03-12,2020-03-16,ACTUAL,,,,,,,2023-10-19,2023-10-23,ACTUAL,2021-12-01,ACTUAL,2021-12-01,2023-10,2023-10-31,2023-07-25,ACTUAL,2023-07-25,2023-07-25,ACTUAL,2023-07-25,,INTERVENTIONAL,,,A Study of Atezolizumab With or Without Tiragolumab Consolidation in Limited Stage Small Cell Lung Cancer,"A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase 2 Study to Investigate the Efficacy and Safety of Atezolizumab With or Without Tiragolumab as Consolidation Therapy in Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed After Chemoradiotherapy",TERMINATED,,PHASE2,24.0,ACTUAL,Hoffmann-La Roche,,2.0,,The sponsor's decision was based on the negative results of SKYSCRAPER-02.,f,,,,t,f,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 15:47:58.487765,2024-10-16 15:47:58.487765,INDUSTRY,,,,,,,2023,0.0
NCT04077398,,2019-08-30,,,2021-02-12,2019-09-03,2019-09-04,ACTUAL,,,,,,,2021-02-12,2021-02-16,ACTUAL,2020-01-22,ACTUAL,2020-01-22,2021-02,2021-02-28,2021-08-01,ESTIMATED,2021-08-01,2021-01-01,ESTIMATED,2021-01-01,,INTERVENTIONAL,,,Volume vs Concentration: Quadratus Lumborum Blocks With High Volume/Low Concentration or Low Volume/ High Concentration in Nephrectomies,"Volume Versus Concentration: a Prospective, Double Blind, Parallel Study to Compare the Clinical Effectiveness of Bilateral Quadratus Lumborum Blocks Using High Volume/Low Concentration or Low Volume/ High Concentration Local Anesthetic in Nephrectomies",WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Pittsburgh,,2.0,,"covid interrupted initial start, then trainees involved finished program and no one took it on",f,,,,t,t,f,,,f,,,,,,NO,there is no plan to share individual participant data.,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,OTHER,,,,,,,2021,0.0
NCT04870606,,2021-04-27,2023-08-14,,2023-12-11,2021-04-29,2021-05-03,ACTUAL,2023-12-11,2024-01-02,ACTUAL,,,,2023-12-11,2024-01-02,ACTUAL,2021-03-05,ACTUAL,2021-03-05,2023-12,2023-12-31,2022-04-06,ACTUAL,2022-04-06,2022-01-24,ACTUAL,2022-01-24,,INTERVENTIONAL,,,Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness,"A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Outpatients With Mild to Moderate COVID-19 Illness",COMPLETED,,PHASE3,733.0,ACTUAL,"Suzhou Kintor Pharmaceutical Inc,",,2.0,,,,,,,,t,f,,,,,,,,,NO,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,INDUSTRY,,,,,,,2022,1.0
NCT01415674,,2011-08-10,,,2022-02-01,2011-08-11,2011-08-12,ESTIMATED,,,,,,,2022-02-01,2022-02-02,ACTUAL,2012-01,,2012-01-31,2022-02,2022-02-28,2021-12,ACTUAL,2021-12-31,2021-12,ACTUAL,2021-12-31,,INTERVENTIONAL,PREDICTOR,,Research of Biomarkers of Activity and Efficacy of BIBW2992 in Untreated Non-metastatic HNSCC Patients,Multi-centric Randomized Phase II Study of Pre-operative Afatinib (BIBW2992) Aiming at Identifying Predictive and Pharmacodynamic Biomarkers of Biological Activity and Efficacy in Untreated Non-metastatic Head and Neck Squamous Cell Carcinoma Patients,COMPLETED,,PHASE2,61.0,ACTUAL,UNICANCER,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,OTHER,,,,,,,2021,1.0
NCT03881371,,2019-03-18,2022-06-09,,2024-03-14,2019-03-18,2019-03-19,ACTUAL,2024-03-14,2024-03-20,ACTUAL,,,,2024-03-14,2024-03-20,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2024-03,2024-03-31,2021-08-20,ACTUAL,2021-08-20,2021-08-20,ACTUAL,2021-08-20,,INTERVENTIONAL,,Safety population were included all patients who provided informed consent and received at least 1 dose or partial dose of study drug.,"A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa","A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa",COMPLETED,,PHASE3,307.0,ACTUAL,Zambon SpA,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,INDUSTRY,,,,,,,2021,1.0
NCT04362085,,2020-04-20,,,2021-10-22,2020-04-23,2020-04-24,ACTUAL,,,,,,,2021-10-22,2021-10-26,ACTUAL,2020-05-11,ACTUAL,2020-05-11,2021-10,2021-10-31,2021-10-14,ACTUAL,2021-10-14,2021-05-10,ACTUAL,2021-05-10,,INTERVENTIONAL,,,Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care,Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care as a Rapid Response to the COVID-19 Pandemic (RAPID COVID COAG),COMPLETED,,PHASE3,465.0,ACTUAL,Unity Health Toronto,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,OTHER,,,,,,,2021,0.0
NCT03729284,,2018-10-16,,,2019-10-02,2018-11-01,2018-11-02,ACTUAL,,,,,,,2019-10-02,2019-10-04,ACTUAL,2020-03-30,ESTIMATED,2020-03-30,2019-10,2019-10-31,2020-06-07,ESTIMATED,2020-06-07,2020-06-07,ESTIMATED,2020-06-07,,INTERVENTIONAL,,,A Study of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta,"A PHASE IV, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY TO DETERMINE THE BIOEQUIVALENCE OF DULOXETINE HYDROCHLORIDE HARD GELATINOUS CAPSULE WITH DELAYED RELEASE MICROGRANULES (60 MG; PFIZER S.R.L - ARGENTINA) COMPARED WITH CYMBALTA(REGISTERED) ( 60 MG; ELI LILLY DO BRASIL LTDA) IN HEALTHY MALE RESEARCH SUBJECTS UNDER FASTED CONDITIONS",WITHDRAWN,,PHASE4,0.0,ACTUAL,Pfizer,,2.0,,This study has been cancelled prior to FSFV due to business reasons,f,,,,f,f,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,INDUSTRY,,,,,,,2020,0.0
NCT01007994,,2009-11-04,2021-03-07,,2021-04-11,2009-11-04,2009-11-05,ESTIMATED,2021-04-11,2021-04-13,ACTUAL,,,,2021-04-11,2021-04-13,ACTUAL,2009-11,ACTUAL,2009-11-30,2021-04,2021-04-30,2020-08,ACTUAL,2020-08-31,2020-01,ACTUAL,2020-01-31,,INTERVENTIONAL,,,Reduction of Night-time Blood Pressure in Pediatric Renal Transplant Recipients,Reduction of Nocturnal Hypertension in Pediatric Renal Transplant Recipients,COMPLETED,,PHASE2/PHASE3,33.0,ACTUAL,Northwell Health,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,OTHER,,,,,,,2020,1.0
NCT05195762,,2021-12-13,,,2024-05-23,2022-01-04,2022-01-19,ACTUAL,,,,,,,2024-05-23,2024-05-28,ACTUAL,2023-06,ESTIMATED,2023-06-30,2024-05,2024-05-31,2024-12,ESTIMATED,2024-12-31,2024-06,ESTIMATED,2024-06-30,,INTERVENTIONAL,,,12-week Study of NFX-179 Gel in Subjects With Epidermal Nevi,"12-Week Clinical Study to Determine the Safety, Tolerability, and Clinical Effect of NFX-179 Gel in Subjects With Epidermal Nevi",WITHDRAWN,,PHASE2,0.0,ACTUAL,Stanford University,,1.0,,Sponsored declined to proceed,f,,,,f,t,f,,,,,,,,,NO,"We will only be sharing participant data with the sponsor, Nflection Therapeutics.",2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,OTHER,,,,,,,2024,0.0
NCT05644587,,2022-11-21,,,2024-08-18,2022-11-30,2022-12-09,ACTUAL,,,,,,,2024-08-18,2024-08-20,ACTUAL,2023-02-06,ACTUAL,2023-02-06,2024-08,2024-08-31,2023-11-30,ACTUAL,2023-11-30,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,,,Novel Induction to Buprenorphine/Naloxone,Novel Induction to Buprenorphine/Naloxone: A Quasi-Experimental Study With Comparison Group,TERMINATED,,PHASE4,33.0,ACTUAL,Bicycle Health,,2.0,,Low enrollment numbers,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,INDUSTRY,,,,,,,2023,0.0
NCT00804856,,2008-09-18,2022-04-06,,2022-12-02,2008-12-08,2008-12-09,ESTIMATED,2022-12-02,2023-10-03,ACTUAL,,,,2022-12-02,2023-10-03,ACTUAL,2008-11-27,ACTUAL,2008-11-27,2022-12,2022-12-31,2021-04-23,ACTUAL,2021-04-23,2012-03-09,ACTUAL,2012-03-09,,INTERVENTIONAL,,"Treated Set: All patients in Phase I who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason. For the Phase II part, the treated set (Phase II) was defined as all patients in Phase II who received at least a single dose of either Volasertib or LDAC.",Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia,"An Open Phase I/IIa Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Intravenous BI 6727 as Monotherapy or in Combination With Subcutaneous Cytarabine in Patients With Acute Myeloid Leukaemia",COMPLETED,,PHASE2,180.0,ACTUAL,Boehringer Ingelheim,,15.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,INDUSTRY,,,,,,,2021,1.0
NCT04028960,,2019-07-19,2021-03-03,,2021-04-26,2019-07-19,2019-07-23,ACTUAL,2021-04-26,2021-05-18,ACTUAL,,,,2021-04-26,2021-05-18,ACTUAL,2019-10-23,ACTUAL,2019-10-23,2020-05,2020-05-31,2020-04-08,ACTUAL,2020-04-08,2020-04-08,ACTUAL,2020-04-08,,INTERVENTIONAL,,"Four subjects were enrolled in the study. Two subjects started the study in the placebo arm and the other two started the study in the Humulin-R arm. During the study, each participant crossed over to the opposite arm of the study so that each subject participated in both arms of the study.",IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase,Intranasal Insulin: A Novel Therapy for Hypoglycemia Unawareness in Type 1 Diabetes,TERMINATED,,PHASE2,4.0,ACTUAL,HealthPartners Institute,The study team was unable to draw conclusions at this time regarding the cognitive testing performed due to abbreviated funding which led to a small number of subjects analyzed.,2.0,,Funding was rescinded,,,,,t,t,f,,,t,,,,,,,,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,OTHER,,,,,,,2020,0.0
NCT03697798,,2018-04-23,,,2021-01-07,2018-10-04,2018-10-05,ACTUAL,,,,,,,2021-01-07,2021-01-08,ACTUAL,2018-04-18,ACTUAL,2018-04-18,2021-01,2021-01-31,2020-01-14,ACTUAL,2020-01-14,2020-01-14,ACTUAL,2020-01-14,,INTERVENTIONAL,BERT,,A Study Exploring Whooping Cough Protection in Children and Adults,"Immunological Effects of an Acellular Pertussis Booster Vaccination in Children, Young Adults and Elderly With Different Immunisation Background. An International Study in Finland, the Netherlands and the United Kingdom",COMPLETED,,PHASE4,122.0,ACTUAL,University of Oxford,,4.0,,,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,OTHER,,,,,,,2020,1.0
NCT05569512,,2022-09-27,,,2024-08-15,2022-10-04,2022-10-06,ACTUAL,,,,,,,2024-08-15,2024-08-19,ACTUAL,2022-10-06,ACTUAL,2022-10-06,2024-08,2024-08-31,2023-12-06,ACTUAL,2023-12-06,2023-10-05,ACTUAL,2023-10-05,,INTERVENTIONAL,,,Uproleselan With Pre-Transplant Conditioning in Hematopoietic Stem Cell Transplantation for AML,A Phase 1/2 Trial of Uproleselan Combined With High Dose Busulfan Pre-Transplant Conditioning in Hematopoietic Stem Cell Transplantation for Patients With Chemotherapy Resistant Acute Myeloid Leukemia,TERMINATED,,PHASE1,1.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,On 7/26/24 the Sponsor-Investigator was notified GlycoMimetics was terminating contracting for NCT05569512 following company restructuring. This notification came ahead of the study meeting criteria to progress from Phase 1 to Phase 2.,f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,OTHER,,,,,,,2023,0.0
NCT04512430,,2020-08-07,,,2024-08-16,2020-08-12,2020-08-13,ACTUAL,,,,,,,2024-08-16,2024-08-20,ACTUAL,2020-12-02,ACTUAL,2020-12-02,2024-08,2024-08-31,2024-07-19,ACTUAL,2024-07-19,2024-07-19,ACTUAL,2024-07-19,,INTERVENTIONAL,,,Neo-DIANA: Neoadjuvant Treatment for EGFR Mutated Patients,A Phase II Trial of Neoadjuvant Treatment Carboplatin-Pemetrexed-Bevacizumab Plus Atezolizumab for the Treatment of Locally Advanced and Potentially Resectable NSCLC Patients With EGFR Mutations,TERMINATED,,PHASE2,4.0,ACTUAL,Fundación GECP,,1.0,,Low recruitment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,OTHER,,,,,,,2024,0.0
NCT03818581,,2019-01-24,2022-11-05,,2024-07-29,2019-01-24,2019-01-28,ACTUAL,2023-02-03,2023-03-02,ACTUAL,,,,2024-07-29,2024-08-20,ACTUAL,2019-03-15,ACTUAL,2019-03-15,2024-07,2024-07-31,2021-11-03,ACTUAL,2021-11-03,2021-11-03,ACTUAL,2021-11-03,,INTERVENTIONAL,,"Four participants in the placebo group dropped out before any baseline or follow-up data could be collected. An additional 4 participants in the treatment group dropped out, leaving only 20 participants with interpretable data.",Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes,Effect of Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes: A Randomized 3-month Clinical Trial Using a Sequential Parallel Comparison Design,COMPLETED,,PHASE4,108.0,ACTUAL,Massachusetts General Hospital,,4.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,OTHER,,,,,,,2021,1.0
NCT05251727,,2022-01-07,,,2024-08-14,2022-02-11,2022-02-23,ACTUAL,,,,,,,2024-08-14,2024-08-19,ACTUAL,2022-03-24,ACTUAL,2022-03-24,2024-08,2024-08-31,2024-06-05,ACTUAL,2024-06-05,2024-06-05,ACTUAL,2024-06-05,,INTERVENTIONAL,,,Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients,"Double-blind, Placebo-controlled, Randomized, Dose-escalating, Multi-center, Phase 1 Study to Assess the Safety and Tolerability of ART-123 With Leucovorin/5-fluorouracil/Oxaliplatin and Bevacizumab in Metastatic Colorectal Cancer Patients",TERMINATED,,PHASE1,77.0,ACTUAL,Veloxis Pharmaceuticals,,6.0,,Business Decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,INDUSTRY,,,,,,,2024,0.0
NCT03834012,,2019-02-06,,,2019-07-15,2019-02-06,2019-02-07,ACTUAL,,,,,,,2019-07-15,2019-07-17,ACTUAL,2019-02,ESTIMATED,2019-02-28,2019-07,2019-07-31,2020-04,ESTIMATED,2020-04-30,2019-11,ESTIMATED,2019-11-30,,INTERVENTIONAL,,,Beclomethasone Dipropionate HFA in Adult and Adolescent Subjects With Persistent Asthma,"A Randomized, Parallel Group, Placebo-controlled, Multicenter Phase 3 Study With a PK Sub-group Study With Beclomethasone HFA at 400 μg and 800 μg Daily Doses Compared to Placebo and QVAR in Persistent Asthma.",WITHDRAWN,,PHASE3,0.0,ACTUAL,Adamis Pharmaceuticals Corporation,,4.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,,,,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,INDUSTRY,,,,,,,2020,0.0
NCT04739358,,2021-01-25,,,2023-10-17,2021-02-01,2021-02-04,ACTUAL,,,,,,,2023-10-17,2023-10-18,ACTUAL,2022-05-25,ACTUAL,2022-05-25,2023-10,2023-10-31,2023-06-23,ACTUAL,2023-06-23,2023-06-23,ACTUAL,2023-06-23,,INTERVENTIONAL,,,CNS Dose Escalation/Expansion of Tepotinib in MET-driven NSCLC,A Phase 1/2 Open-Label Study To Determine a Central Nervous System (CNS) Dose and Schedule Of Tepotinib Alone Or In Combination With Other Relevant Tyrosine Kinase Inhibitors (TKIs) In Adult Participants With MET-Driven NSCLC,TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,"Criterium, Inc.",,2.0,,Study was terminated due to lack of lack of enrollment and difficult patient population.,,,,,t,t,f,,,,,,,,,,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,INDUSTRY,,,,,,,2023,0.0
NCT02545283,,2015-08-31,2021-04-22,,2021-12-28,2015-09-08,2015-09-09,ESTIMATED,2021-08-17,2021-09-14,ACTUAL,,,,2021-12-28,2022-01-11,ACTUAL,2015-12-30,ACTUAL,2015-12-30,2021-12,2021-12-31,2020-04-24,ACTUAL,2020-04-24,2020-04-24,ACTUAL,2020-04-24,,INTERVENTIONAL,MIRROS,,A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML),"A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Study of Idasanutlin, an MDM2 Antagonist, With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)",TERMINATED,,PHASE3,447.0,ACTUAL,Hoffmann-La Roche,,2.0,,The study was stopped for futility based on efficacy results at the interim analysis; no unexpected safety findings were observed.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,INDUSTRY,,,,,,,2020,0.0
NCT05395052,,2022-05-13,,,2023-09-19,2022-05-25,2022-05-27,ACTUAL,,,,,,,2023-09-19,2023-09-21,ACTUAL,2022-05-31,ACTUAL,2022-05-31,2023-09,2023-09-30,2023-08-11,ACTUAL,2023-08-11,2023-08-11,ACTUAL,2023-08-11,,INTERVENTIONAL,,,FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors,"A Phase I, Open-Label, Multicenter Study of FT536 as Monotherapy and in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,5.0,ACTUAL,Fate Therapeutics,,6.0,,This study was terminated by the Sponsor.,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,INDUSTRY,,,,,,,2023,0.0
NCT02782104,,2016-04-29,2023-12-29,,2024-02-16,2016-05-20,2016-05-25,ESTIMATED,2024-02-16,2024-02-20,ACTUAL,,,,2024-02-16,2024-02-20,ACTUAL,2016-06-09,ACTUAL,2016-06-09,2024-02,2024-02-29,2022-12-30,ACTUAL,2022-12-30,2022-12-30,ACTUAL,2022-12-30,,INTERVENTIONAL,SUSTAIN-3,,A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression,An Open-label Long-term Extension Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression,COMPLETED,,PHASE3,1148.0,ACTUAL,"Janssen Research & Development, LLC",,1.0,,,f,,,,t,,f,,,,,,,,,,,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,INDUSTRY,,,,,,,2022,0.0
NCT03850522,,2019-02-19,,,2022-04-08,2019-02-20,2019-02-21,ACTUAL,,,,,,,2022-04-08,2022-04-15,ACTUAL,2019-02-18,ACTUAL,2019-02-18,2022-04,2022-04-30,2021-03-10,ACTUAL,2021-03-10,2021-03-10,ACTUAL,2021-03-10,,INTERVENTIONAL,,,PD-L1 Peptide Vaccination in High Risk Smoldering Multiple Myeloma,Phase IIa Trial of PD-L1 Peptide Vaccination as Monotherapy in High Risk Smoldering Multiple Myeloma,TERMINATED,,PHASE2,6.0,ACTUAL,Herlev Hospital,,1.0,,Insufficient recruitment within planned enrolmentperiod.,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,OTHER,,,,,,,2021,0.0
NCT04442503,,2020-06-18,2023-04-11,,2023-11-27,2020-06-18,2020-06-22,ACTUAL,2023-06-21,2023-06-22,ACTUAL,,,,2023-11-27,2023-11-30,ACTUAL,2020-06-08,ACTUAL,2020-06-08,2023-11,2023-11-30,2022-04-12,ACTUAL,2022-04-12,2022-03-15,ACTUAL,2022-03-15,,INTERVENTIONAL,,Safety Set included all participants who were administered Investigational product (IP).,A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD),"A Randomized, Double-Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of SAGE-217 in the Treatment of Adults With Severe Postpartum Depression",COMPLETED,,PHASE3,200.0,ACTUAL,Biogen,,2.0,,,f,,,,f,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,INDUSTRY,,,,,,,2022,1.0
NCT03797612,,2019-01-06,,,2020-07-09,2019-01-06,2019-01-09,ACTUAL,,,,,,,2020-07-09,2020-07-13,ACTUAL,2021-01,ESTIMATED,2021-01-31,2020-07,2020-07-31,2022-02,ESTIMATED,2022-02-28,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,,,Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Knee Replacement in Patients With High PCS Scores,"A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Intrathecal Preoperative Administration of Brivoligide Injection in Patients With a Pain Catastrophizing Scale Score ≥16 Undergoing Unilateral Total Knee Arthroplasty",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Adynxx, Inc.",,2.0,,Study initiation delayed due to COVID 19,f,,,,f,t,f,,,,,,,,,NO,Individual participant data will not be made available to other researchers.,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,INDUSTRY,,,,,,,2022,0.0
NCT01860404,,2013-05-20,2024-01-29,,2024-04-17,2013-05-20,2013-05-22,ESTIMATED,2024-04-17,2024-05-14,ACTUAL,,,,2024-04-17,2024-05-14,ACTUAL,2014-01,ACTUAL,2014-01-31,2024-04,2024-04-30,2023-01,ACTUAL,2023-01-31,2023-01,ACTUAL,2023-01-31,,INTERVENTIONAL,HIT_HEADS,Includes all 42 patients randomized,BCAA Supplementation for Concussion,"Head Injury Treatment With Healthy and Advanced Dietary Supplements (HIT HEADS): A Randomized, Placebo-controlled, Double-blinded, Therapeutic Exploratory Clinical Trial of Branched Chain Amino Acids (BCAA's) in the Treatment of Concussion",COMPLETED,,PHASE2,42.0,ACTUAL,Children's Hospital of Philadelphia,"There are several key limitations to our study that necessitate a larger, more definitive trial. Due to a combination of initially more strict inclusion criteria, and the impact of the coronavirus pandemic, our sample size was smaller than anticipated. This, combined with poorer than expected follow-up, led us to have to use alternative statistical analytic methods. We were further limited by missing data. This also necessitated the alternative analytic approach / post-hoc analysis.",5.0,,,f,,,,f,,,,,,,,,,,,,2024-10-17 02:36:11.649977,2024-10-17 02:36:11.649977,OTHER,,,,,,,2023,1.0
NCT04810962,,2021-03-18,2023-06-15,,2023-07-12,2021-03-19,2021-03-23,ACTUAL,2023-06-15,2023-07-07,ACTUAL,,,,2023-07-12,2023-07-25,ACTUAL,2021-03-16,ACTUAL,2021-03-16,2023-07,2023-07-31,2022-07-06,ACTUAL,2022-07-06,2022-07-06,ACTUAL,2022-07-06,,INTERVENTIONAL,,Intent-to-Treat Population,Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study,"A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of APP13007 for the Treatment of Inflammation and Pain After Cataract Surgery, Including a Corneal Endothelial Cell Sub-study",COMPLETED,,PHASE3,370.0,ACTUAL,"Formosa Pharmaceuticals, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,INDUSTRY,,,,,,,2022,1.0
NCT03188185,,2017-06-09,2021-02-19,,2021-03-15,2017-06-14,2017-06-15,ACTUAL,2021-02-19,2021-03-15,ACTUAL,,,,2021-03-15,2021-04-08,ACTUAL,2017-06-12,ACTUAL,2017-06-12,2021-03,2021-03-31,2020-03-05,ACTUAL,2020-03-05,2020-02-26,ACTUAL,2020-02-26,,INTERVENTIONAL,,,A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD),A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder,COMPLETED,,PHASE3,278.0,ACTUAL,"Alkermes, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,INDUSTRY,,,,,,,2020,1.0
NCT03483103,,2018-03-23,2022-09-23,,2023-11-28,2018-03-23,2018-03-30,ACTUAL,2022-12-09,2022-12-29,ACTUAL,,,,2023-11-28,2023-12-20,ACTUAL,2018-07-27,ACTUAL,2018-07-27,2023-11,2023-11-30,2022-12-01,ACTUAL,2022-12-01,2021-09-24,ACTUAL,2021-09-24,,INTERVENTIONAL,,74 participants were leukapheresed.,Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006),A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL (017006),COMPLETED,,PHASE2,74.0,ACTUAL,"Juno Therapeutics, a Subsidiary of Celgene",,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,INDUSTRY,,,,,,,2022,1.0
NCT03535688,,2018-04-03,,,2024-07-11,2018-05-14,2018-05-24,ACTUAL,,,,,,,2024-07-11,2024-07-15,ACTUAL,2018-03-30,ACTUAL,2018-03-30,2024-07,2024-07-31,2024-02-07,ACTUAL,2024-02-07,2024-02-07,ACTUAL,2024-02-07,,INTERVENTIONAL,,,"D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain","D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain",TERMINATED,,PHASE2,203.0,ACTUAL,Northwestern University,,2.0,,Insufficient funding to complete the study,f,,,,t,t,f,,,,,,,,,,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,OTHER,,,,,,,2024,0.0
NCT04978779,,2021-07-15,,,2023-11-14,2021-07-20,2021-07-27,ACTUAL,,,,,,,2023-11-14,2023-11-18,ACTUAL,2021-12-16,ACTUAL,2021-12-16,2023-11,2023-11-30,2023-05-26,ACTUAL,2023-05-26,2023-05-26,ACTUAL,2023-05-26,,INTERVENTIONAL,,,A Study to Evaluate VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome,"An Open-label, Multicenter Phase 1/1b Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of VIP152 Monotherapy or Combination Therapy in Subjects With High-risk Chronic Lymphocytic Leukemia or Richter Syndrome",TERMINATED,,PHASE1,6.0,ACTUAL,"Vincerx Pharma, Inc.",,2.0,,Slow enrollment,f,,,,,t,f,,,,,,,,,,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,INDUSTRY,,,,,,,2023,0.0
NCT03317496,,2017-09-29,2022-05-26,,2023-08-04,2017-10-17,2017-10-23,ACTUAL,2022-05-26,2022-06-23,ACTUAL,,,,2023-08-04,2023-08-29,ACTUAL,2017-12-21,ACTUAL,2017-12-21,2023-08,2023-08-31,2022-12-20,ACTUAL,2022-12-20,2021-06-07,ACTUAL,2021-06-07,,INTERVENTIONAL,,,Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies,"A MULTICENTER, OPEN-LABEL, PHASE 1B/2 STUDY TO EVALUATE SAFETY AND EFFICACY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH CHEMOTHERAPY WITH OR WITHOUT OTHER ANTI-CANCER IMMUNOTHERAPIES AS FIRST-LINE TREATMENT IN PATIENTS WITH ADVANCED MALIGNANCIES",TERMINATED,,PHASE1/PHASE2,67.0,ACTUAL,Pfizer,The study was terminated since there was no need for further safety or efficacy data to be collected. The subjects having benefit from the investigational treatments have been moved to a continuation study NCT05059522,4.0,,The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the investigational treatments have been moved to a continuation study (NCT05059522).,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,INDUSTRY,,,,,,,2022,0.0
NCT04405102,,2020-05-26,,,2024-02-16,2020-05-26,2020-05-28,ACTUAL,,,,,,,2024-02-16,2024-02-20,ACTUAL,2020-09-16,ACTUAL,2020-09-16,2024-02,2024-02-29,2022-05-12,ACTUAL,2022-05-12,2022-03-14,ACTUAL,2022-03-14,,INTERVENTIONAL,COZI,,COVID-19 Ozanimod Intervention Study,A Randomized Trial on Efficacy and Safety of Ozanimod for the Treatment of COVID-19 Patients Requiring Oxygen Support - A Pilot Trial,TERMINATED,,PHASE2,43.0,ACTUAL,"Institut universitaire de cardiologie et de pneumologie de Québec, University Laval",,2.0,,"Screening was stopped by the Sponsor (43/48 participants enrolled), given the very low number of eligible patients (high vaccination rate and occurrence of the Omicron variant). The last patient randomized performed his follow-up visit.",f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,OTHER,,,,,,,2022,0.0
NCT04464460,,2020-07-08,,,2020-10-07,2020-07-08,2020-07-09,ACTUAL,,,,,,,2020-10-07,2020-10-08,ACTUAL,2020-09-25,ESTIMATED,2020-09-25,2020-10,2020-10-31,2020-10-30,ESTIMATED,2020-10-30,2020-10-30,ESTIMATED,2020-10-30,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Pharmacokinetics (PK), and Efficacy of TAK-671 for the Treatment of Coronavirus Disease (COVID) 2019 in Adults","A Randomized, Double-blind, Placebo-Controlled Multicenter Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of 2 Different Intravenous Doses of TAK-671 for the Treatment of Coronavirus Disease 2019 in Adults",WITHDRAWN,,PHASE1,0.0,ACTUAL,Takeda,,2.0,,Business Decision (no enrollment),f,,,,f,t,f,,,,,,,,,YES,"Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,INDUSTRY,,,,,,,2020,0.0
NCT05295589,,2022-03-23,,,2023-09-22,2022-03-23,2022-03-25,ACTUAL,,,,,,,2023-09-22,2023-09-26,ACTUAL,2022-06-30,ESTIMATED,2022-06-30,2023-09,2023-09-30,2023-03-17,ESTIMATED,2023-03-17,2023-03-17,ESTIMATED,2023-03-17,,INTERVENTIONAL,,,Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy,"A Randomized Phase II Trial Comparing the Combination of PI3K Inhibitor Copanlisib (BAY 80-6946) and PARP Inhibitor Olaparib (AZD2281) to Standard Chemotherapy in Patients With Recurrent Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Progressed Through Prior PARP Inhibitor Therapy",WITHDRAWN,,PHASE2,0.0,ACTUAL,National Cancer Institute (NCI),,2.0,,Drug supply issues,f,,,,f,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.",2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,NIH,,,,,,,2023,0.0
NCT04871113,,2021-04-28,2023-10-27,,2024-09-18,2021-04-28,2021-05-04,ACTUAL,2023-10-27,2023-11-18,ACTUAL,,,,2024-09-18,2024-10-15,ACTUAL,2021-06-22,ACTUAL,2021-06-22,2024-09,2024-09-30,2023-09-21,ACTUAL,2023-09-21,2022-10-27,ACTUAL,2022-10-27,,INTERVENTIONAL,,,"A Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A in Viremic Human Immunodeficiency Virus (HIV)-1 Infected Adults","A Phase 2a Multicentre, Randomized, Open-Label, Two-Part Adaptive Design Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A, an HIV-1 Specific Broadly Neutralizing Human Monoclonal Antibody in Antiretroviral-naïve HIV-1-Infected Adults",COMPLETED,,PHASE2,62.0,ACTUAL,ViiV Healthcare,,10.0,,,f,,,,f,t,f,,,,,,"Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.",https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf,YES,"GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf.",2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,INDUSTRY,,,,,,,2023,1.0
NCT03483753,,2018-02-05,,,2023-10-02,2018-03-29,2018-03-30,ACTUAL,,,,,,,2023-10-02,2023-10-05,ACTUAL,2019-01,ESTIMATED,2019-01-31,2023-10,2023-10-31,2023-10-02,ACTUAL,2023-10-02,2023-10-02,ACTUAL,2023-10-02,,INTERVENTIONAL,VANCSIII,,Vasopressin or Norepinephrine in Vasoplegic Shock After Non-cardiac Surgery,Vasopressin or Norepinephrine in Vasoplegic Shock After Non-cardiac Surgery: a Randomized and Controlled Trial,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,University of Sao Paulo,,2.0,,no funding for the study,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,OTHER,,,,,,,2023,0.0
NCT00002874,,1999-11-01,2017-06-06,,2022-05-23,2003-01-26,2003-01-27,ESTIMATED,2017-07-18,2017-08-18,ACTUAL,,,,2022-05-23,2022-06-15,ACTUAL,1998-02,,1998-02-28,2022-05,2022-05-31,2022-05-20,ACTUAL,2022-05-20,2015-08,ACTUAL,2015-08-31,,INTERVENTIONAL,,Eligible patients who have not withdrawn,Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy,A PHASE III TRIAL OF RADIATION THERAPY WITH OR WITHOUT CASODEX IN PATIENTS WITH PSA ELEVATION FOLLOWING RADICAL PROSTATECTOMY FOR pT3N0 CARCINOMA OF THE PROSTATE,COMPLETED,,PHASE3,840.0,ACTUAL,Radiation Therapy Oncology Group,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,NETWORK,,,,,,,2022,1.0
NCT02504203,,2015-07-20,,,2022-02-03,2015-07-20,2015-07-21,ESTIMATED,,,,,,,2022-02-03,2022-02-04,ACTUAL,2015-11,,2015-11-30,2022-02,2022-02-28,2021-06,ACTUAL,2021-06-30,2021-06,ACTUAL,2021-06-30,,INTERVENTIONAL,BCGR,,Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial,Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial,TERMINATED,,PHASE4,2332.0,ACTUAL,Bandim Health Project,,2.0,,Due to fewer than expected children enrolled and lower than expected overall mortality rate.,f,,,,t,,,,,,,,,,,,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,OTHER,,,,,,,2021,0.0
NCT04203056,,2019-12-16,2023-09-30,,2023-11-04,2019-12-16,2019-12-18,ACTUAL,2023-11-04,2023-11-28,ACTUAL,,,,2023-11-04,2023-11-28,ACTUAL,2019-12-16,ACTUAL,2019-12-16,2023-11,2023-11-30,2022-10-01,ACTUAL,2022-10-01,2022-10-01,ACTUAL,2022-10-01,,INTERVENTIONAL,APPRAISE,,Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode,Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode,TERMINATED,,PHASE4,15.0,ACTUAL,"University of California, Los Angeles",,2.0,,Withdraw of financial support by industry collaborator,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,OTHER,,,,,,,2022,0.0
NCT04470427,,2020-07-11,2023-12-21,,2024-03-19,2020-07-11,2020-07-14,ACTUAL,2024-03-19,2024-03-21,ACTUAL,,,,2024-03-19,2024-03-21,ACTUAL,2020-07-27,ACTUAL,2020-07-27,2024-03,2024-03-31,2022-12-29,ACTUAL,2022-12-29,2022-12-29,ACTUAL,2022-12-29,,INTERVENTIONAL,,All randomized participants who received at least 1 dose of treatment.,"A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19","A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older",COMPLETED,,PHASE3,30415.0,ACTUAL,"ModernaTX, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,INDUSTRY,,,,,,,2022,1.0
NCT03325439,,2017-10-25,2022-06-22,,2024-04-04,2017-10-25,2017-10-30,ACTUAL,2023-04-20,2024-01-16,ACTUAL,,,,2024-04-04,2024-04-08,ACTUAL,2019-05-07,ACTUAL,2019-05-07,2024-04,2024-04-30,2021-05-29,ACTUAL,2021-05-29,2020-09-03,ACTUAL,2020-09-03,,INTERVENTIONAL,,"Baseline Characteristics refer to the All Study Participants Screened Set which consisted of all study participants who had signed the Informed Consent form (ICF) and underwent the study inclusion and exclusion criteria of the current protocol. No eligible study participants were enrolled in the Confirmatory Cohorts. The study stopped prematurely due to enrolment challenges, the termination was not linked to any safety issues.","A Study to Test the Pharmacokinetics, Efficacy, and Safety of Brivaracetam in Newborns With Repeated Electroencephalographic Seizures","A Multicenter, Open-Label, Single-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Brivaracetam in Neonates With Repeated Electroencephalographic Seizures",TERMINATED,,PHASE3,9.0,ACTUAL,UCB Pharma,"No eligible study participants were enrolled in the Confirmatory Cohorts. The study stopped prematurely due to enrolment challenges, the termination was not linked to any safety issues.",1.0,,"Terminated (The study stopped prematurely due to enrolment challenges, the termination was not linked to any safety issues.)",f,,,,t,f,f,,,,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",https://vivli.org/,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,INDUSTRY,,,,,,,2021,0.0
NCT03018730,,2017-01-09,2022-06-02,,2023-09-11,2017-01-10,2017-01-12,ESTIMATED,2022-06-02,2022-06-29,ACTUAL,,,,2023-09-11,2023-09-13,ACTUAL,2017-05-17,ACTUAL,2017-05-17,2023-09,2023-09-30,2020-01-09,ACTUAL,2020-01-09,2019-12-17,ACTUAL,2019-12-17,,INTERVENTIONAL,,,Safety and Efficacy of PRX-102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa),An Open Label Study of the Safety and Efficacy of PRX-102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa),COMPLETED,,PHASE3,22.0,ACTUAL,Protalix,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,INDUSTRY,,,,,,,2020,1.0
NCT05413642,,2022-06-09,,,2024-02-12,2022-06-09,2022-06-10,ACTUAL,,,,,,,2024-02-12,2024-02-14,ACTUAL,2023-07-01,ACTUAL,2023-07-01,2024-02,2024-02-29,2024-02-06,ACTUAL,2024-02-06,2024-02-06,ACTUAL,2024-02-06,,INTERVENTIONAL,COVER-HOME,,COVID-19 Algorithm Treatment at Home,"Prevention of Hospitalization of Patients With Early COVID-19 by an Anti-inflammatory Drug-based Home-treatment Algorithm:a Three-months, Pragmatic, Cluster Randomized, Open-label, Blinded Endpoint (PROBE) Trial",WITHDRAWN,,PHASE3,0.0,ACTUAL,Mario Negri Institute for Pharmacological Research,,2.0,,"Due to changes in the monitoring rules for SARS-CoV-2 and the dramatic reduction in COVID-19 cases, it became extremely difficult to recruit the required number of patients provided by the study protocol to meet the study's primary objective.",f,,,,f,f,f,,,,,,,,,,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,OTHER,,,,,,,2024,0.0
NCT03558724,,2018-05-17,,,2024-04-14,2018-06-14,2018-06-15,ACTUAL,,,,,,,2024-04-14,2024-04-16,ACTUAL,2018-10-29,ACTUAL,2018-10-29,2024-04,2024-04-30,2022-10-11,ACTUAL,2022-10-11,2022-10-11,ACTUAL,2022-10-11,,INTERVENTIONAL,ORCA,,Fluorescence Endoscopy of Esophageal Carcinoma,Fluorescence Molecular Endoscopy of Locally Advanced Esophageal Carcinoma Using Bevacizumab-800CW to Evaluate Dose Response After Neoadjuvant Chemoradiotherapy: a Single-center Feasibility Study.,TERMINATED,,PHASE1,25.0,ACTUAL,University Medical Center Groningen,,3.0,,"Dose-escalation was finished, but no clear correlation between fluorescence and tumor grade was established",f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,OTHER,,,,,,,2022,0.0
NCT04289948,,2018-09-03,,,2020-02-26,2020-02-26,2020-02-28,ACTUAL,,,,,,,2020-02-26,2020-02-28,ACTUAL,2019-03-01,ESTIMATED,2019-03-01,2020-02,2020-02-29,2022-09-01,ESTIMATED,2022-09-01,2022-06-01,ESTIMATED,2022-06-01,,INTERVENTIONAL,PDFI,,Assessing the Efficacy of Anti-staphylococcal Phages in the Management of Infected Foot Ulcers in Diabetes,Assessing the Efficacy of Anti-staphylococcal Phages in the Management of Infected Foot Ulcers in Diabetes,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University Hospitals of Derby and Burton NHS Foundation Trust,,2.0,,Funding issues meant that development of the study was halted.,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,OTHER,,,,,,,2022,0.0
NCT04324840,,2020-03-25,,,2024-07-25,2020-03-25,2020-03-27,ACTUAL,,,,,,,2024-07-25,2024-07-26,ACTUAL,2020-07-10,ACTUAL,2020-07-10,2024-07,2024-07-31,2024-07-09,ACTUAL,2024-07-09,2024-07-09,ACTUAL,2024-07-09,,INTERVENTIONAL,,,A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma,"A Phase 1b, Open-label, Dose-Finding Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Subjects With Newly Diagnosed Glioblastoma",TERMINATED,,PHASE1,184.0,ACTUAL,Celgene,,3.0,,Business objectives have changed,f,,,,f,f,f,,,,,,See Plan Description,See Plan Description,https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,INDUSTRY,,,,,,,2024,0.0
NCT05229900,,2022-01-26,,,2023-12-22,2022-02-07,2022-02-08,ACTUAL,,,,,,,2023-12-22,2023-12-28,ACTUAL,2022-04-21,ACTUAL,2022-04-21,2023-12,2023-12-31,2023-12-13,ACTUAL,2023-12-13,2023-12-13,ACTUAL,2023-12-13,,INTERVENTIONAL,,,A Study of SGN-ALPV in Advanced Solid Tumors,A Phase 1 Study of SGN-ALPV in Advanced Solid Tumors,TERMINATED,,PHASE1,43.0,ACTUAL,Seagen Inc.,,1.0,,Study closed due to portfolio prioritization,f,,,,f,t,f,,,,,,,,,,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,INDUSTRY,,,,,,,2023,0.0
NCT03173963,,2017-05-27,,,2020-02-24,2017-06-01,2017-06-02,ACTUAL,,,,,,,2020-02-24,2020-02-25,ACTUAL,2017-05-27,ACTUAL,2017-05-27,2020-02,2020-02-29,2020-02-21,ACTUAL,2020-02-21,2020-02-21,ACTUAL,2020-02-21,,INTERVENTIONAL,,,Empaglifozin in Early Diabetic Kidney Disease,Empagliflozin in Early Diabetic Kidney Disease,WITHDRAWN,,PHASE3,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,"Original drug sponsor withdrew from study, replacement sponsor not obtained.",f,,,,,f,f,,,,,,,,,,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,NIH,,,,,,,2020,0.0
NCT03743194,,2018-10-31,2023-08-30,,2023-12-11,2018-11-13,2018-11-16,ACTUAL,2023-12-11,2023-12-29,ACTUAL,,,,2023-12-11,2023-12-29,ACTUAL,2021-12-14,ACTUAL,2021-12-14,2023-12,2023-12-31,2022-03-14,ACTUAL,2022-03-14,2022-02-28,ACTUAL,2022-02-28,,INTERVENTIONAL,,,Pectoralis and Serratus Muscle Blocks,Pectoralis and Serratus Muscle Blocks for Analgesia After Minimally Invasive Cardiac Procedures,COMPLETED,,PHASE4,210.0,ACTUAL,The Cleveland Clinic,,2.0,,,f,,,,f,t,f,,,f,,,,,,,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,OTHER,,,,,,,2022,1.0
NCT05201001,,2021-07-09,,,2023-09-07,2022-01-07,2022-01-21,ACTUAL,,,,,,,2023-09-07,2023-09-11,ACTUAL,2023-09-07,ACTUAL,2023-09-07,2022-04,2022-04-30,2023-09-07,ACTUAL,2023-09-07,2023-09-07,ACTUAL,2023-09-07,,INTERVENTIONAL,APX005M,,APX005M in Patients With Recurrent Ovarian Cancer,An Early Phase Randomized Trial of APX005M in BRCAwt Patients With Recurrent Ovarian Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,Nordic Society of Gynaecological Oncology - Clinical Trials Unit,,3.0,,"IMP provider company (Apexigen) is sold, thus both IMP and grant is terminated",f,,,,t,f,f,,,,,,,,,UNDECIDED,NSGO-CTU can be contacted,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,OTHER,,,,,,,2023,0.0
NCT04051801,,2019-07-19,,,2021-05-25,2019-08-07,2019-08-09,ACTUAL,,,,,,,2021-05-25,2021-05-28,ACTUAL,2021-05-25,ACTUAL,2021-05-25,2021-05,2021-05-31,2021-05-25,ACTUAL,2021-05-25,2021-05-25,ACTUAL,2021-05-25,,INTERVENTIONAL,,,Multiple Ascending Dose Putative Cognitive Enhancer VU319,Multiple Ascending Dose Phase I Study of the M1 Positive Allosteric Modulator VU0467319,WITHDRAWN,,PHASE1,0.0,ACTUAL,Vanderbilt University Medical Center,,6.0,,Further development has been outlicensed to Acadia Pharmaceuticals,,,,,t,t,f,,,,,,,,,,,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,OTHER,,,,,,,2021,0.0
NCT03010865,,2016-12-28,,,2019-01-15,2017-01-03,2017-01-05,ESTIMATED,,,,,,,2019-01-15,2019-01-17,ACTUAL,2017-06-01,ACTUAL,2017-06-01,2017-06,2017-06-30,2020-02,ESTIMATED,2020-02-29,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,Sodium Butyrate For Improving Cognitive Function In Schizophrenia,Sodium Butyrate As A Treatment For Improving Cognitive Function In Schizophrenia,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Shanghai Mental Health Center,,2.0,,sponsor withdrew the funds because the smell of sodium butyrate made blinding impossible,f,,,,f,f,f,,,,,,,,,UNDECIDED,"Stanley foundation requests: Based on the terms of your award, Stanley Medical Research Institute (SMRI) now requires submission of the individual patient data from all SMRI funded studies. In order to make the process as efficient as possible and provide a secure location for study data, National Institute of Mental Health (NIMH) is graciously allowing SMRI access to their National Database for Clinical Trials (NDCT) to collect and house data.",2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,OTHER,,,,,,,2020,0.0
NCT04760626,,2021-02-17,,2023-08-10,2024-08-06,2021-02-17,2021-02-18,ACTUAL,,,,,2023-08-15,ACTUAL,2024-08-06,2024-08-07,ACTUAL,2021-03-01,ACTUAL,2021-03-01,2024-08,2024-08-31,2022-08-29,ACTUAL,2022-08-29,2022-08-12,ACTUAL,2022-08-12,,INTERVENTIONAL,ONWARDS 5,,"A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before",Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting,COMPLETED,,PHASE3,1085.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-17 02:42:19.961335,2024-10-17 02:42:19.961335,INDUSTRY,,,,,,,2022,1.0
NCT03941483,,2019-05-06,2022-07-23,,2023-04-20,2019-05-06,2019-05-08,ACTUAL,2022-09-08,2022-10-04,ACTUAL,,,,2023-04-20,2023-04-24,ACTUAL,2019-11-01,ACTUAL,2019-11-01,2023-04,2023-04-30,2021-10-20,ACTUAL,2021-10-20,2021-07-26,ACTUAL,2021-07-26,,INTERVENTIONAL,,ASP1128 and Placebo: Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study treatment.~Observational Cohort: NC negative participants who were enrolled in the observational cohort.,Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury (AKI) Following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery,"A Phase 2 Proof of Concept, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury Following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery",COMPLETED,,PHASE2,351.0,ACTUAL,Astellas Pharma Inc,,3.0,,,f,,,,t,t,f,,,,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://clinicalstudydatarequest.com,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,INDUSTRY,,,,,,,2021,1.0
NCT03679884,,2018-09-19,2022-01-07,,2022-02-07,2018-09-20,2018-09-21,ACTUAL,2022-02-07,2022-03-02,ACTUAL,,,,2022-02-07,2022-03-02,ACTUAL,2018-10-09,ACTUAL,2018-10-09,2022-02,2022-02-28,2021-02-22,ACTUAL,2021-02-22,2021-02-22,ACTUAL,2021-02-22,,INTERVENTIONAL,,These are the participants included in the FAS. The discrepancy with previous table (Participant Flow) is due to 3 subjects on FAS (2 on daridorexant 25 mg and 1 on ex-placebo/ daridorexant 25 mg) not starting DB treatment.,Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep,"Multi-center, Double-blind, Parallel-group, Randomized, Placebo-controlled, Three Doses, 40-week Extension to Studies ID-078A301 and ID-078A302 to Assess the Long Term Safety and Tolerability of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder",COMPLETED,,PHASE3,804.0,ACTUAL,Idorsia Pharmaceuticals Ltd.,,5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,INDUSTRY,,,,,,,2021,1.0
NCT02478502,,2014-08-28,,,2024-02-01,2015-06-22,2015-06-23,ESTIMATED,,,,,,,2024-02-01,2024-02-02,ACTUAL,2015-06,,2015-06-30,2024-02,2024-02-29,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,Testis CAB: Cabazitaxel as Salvage Treatment for Cisplatin-resistant Germ Cell Cancer,Phase 2 Study Cabazitaxel as Salvage Treatment for Cisplatin-resistant Germ Cell,TERMINATED,,PHASE2,14.0,ACTUAL,"University Hospital, Akershus",,1.0,,Insufficient recruitment,f,,,,t,,,,,,,,,,,,,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,OTHER,,,,,,,2022,0.0
NCT04602000,,2020-10-18,2022-05-10,,2022-06-27,2020-10-23,2020-10-26,ACTUAL,2022-06-27,2022-07-20,ACTUAL,,,,2022-06-27,2022-07-20,ACTUAL,2020-10-05,ACTUAL,2020-10-05,2022-06,2022-06-30,2021-10-20,ACTUAL,2021-10-20,2021-05-21,ACTUAL,2021-05-21,,INTERVENTIONAL,,,A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 Infection,"A Phase 2/3, Randomized, Parallel-group, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of CT-P59 in Combination With Standard of Care in Outpatients With SARS-CoV-2 Infection",COMPLETED,,PHASE2/PHASE3,1642.0,ACTUAL,Celltrion,,5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,INDUSTRY,,,,,,,2021,1.0
NCT03298061,,2017-09-27,2024-02-14,,2024-02-14,2017-09-27,2017-09-29,ACTUAL,2024-02-14,2024-03-12,ACTUAL,,,,2024-02-14,2024-03-12,ACTUAL,2015-04-14,ACTUAL,2015-04-14,2024-02,2024-02-29,2023-02-16,ACTUAL,2023-02-16,2023-02-16,ACTUAL,2023-02-16,,INTERVENTIONAL,,,Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921,Mepolizumab Long-term Access Programme for Subjects Who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard-of-care Therapy),COMPLETED,,PHASE3,100.0,ACTUAL,GlaxoSmithKline,,1.0,,,t,,,,t,t,f,,,,,,,,,,,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,INDUSTRY,,NCT00244686,NO_LONGER_AVAILABLE,,,,2023,1.0
NCT06119529,,2023-11-01,,,2024-07-24,2023-11-01,2023-11-07,ACTUAL,,,,,,,2024-07-24,2024-07-25,ACTUAL,2023-11-01,ACTUAL,2023-11-01,2024-07,2024-07-31,2024-04-08,ACTUAL,2024-04-08,2024-04-08,ACTUAL,2024-04-08,,INTERVENTIONAL,,,A Study of LY3872386 in Healthy Participants and Participants With Atopic Dermatitis,"A Phase 1, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Single-Ascending Dose Study of LY3872386 in Healthy Participants, a Multiple-Ascending Dose Study of LY3872386 in Patients With Atopic Dermatitis, and an Open-Label Multiple-Dose Evaluation of the Safety and Tolerability of Prednisone in Healthy Participants.",TERMINATED,,PHASE1,18.0,ACTUAL,Eli Lilly and Company,,4.0,,"Based on emerging nonclinical data, the study was terminated.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,INDUSTRY,,,,,,,2024,0.0
NCT04433078,,2020-06-10,,,2021-04-13,2020-06-12,2020-06-16,ACTUAL,,,,,,,2021-04-13,2021-04-19,ACTUAL,2020-06-22,ACTUAL,2020-06-22,2021-04,2021-04-30,2021-04-13,ACTUAL,2021-04-13,2021-04-13,ACTUAL,2021-04-13,,INTERVENTIONAL,STORM,,RepurpoSing Old Drugs TO SuppRess a Modern Threat: COVID-19 STORM,RepurpoSing Old Drugs TO SuppRess a Modern Threat: The STORM Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,Temple University,,2.0,,No Participants Enrolled,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 18:03:23.937454,2024-10-15 18:03:23.937454,OTHER,,,,,,,2021,0.0
NCT04600323,,2020-10-19,,,2024-05-07,2020-10-19,2020-10-23,ACTUAL,,,,,,,2024-05-07,2024-05-08,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2024-05,2024-05-31,2023-08-30,ACTUAL,2023-08-30,2023-08-30,ACTUAL,2023-08-30,,INTERVENTIONAL,,,Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD,Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD,COMPLETED,,EARLY_PHASE1,34.0,ACTUAL,"University of Colorado, Denver",,2.0,,,f,,,,t,t,f,,,f,,,"At the conclusion of the study, data, which has been stripped of all personal identification information and coded with a number, will be made available to qualified individuals within the scientific community who apply for data use. The results and outcomes of this study will be made generally available by publication and journal articles submitted to PubMed Central in compliance with NIH access guidelines.",,,YES,,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,OTHER,,,,,,,2023,1.0
NCT03329001,,2017-10-23,2022-12-19,,2024-07-17,2017-10-30,2017-11-01,ACTUAL,2023-11-13,2024-04-26,ACTUAL,,,,2024-07-17,2024-07-25,ACTUAL,2017-12-04,ACTUAL,2017-12-04,2024-07,2024-07-31,2023-06-15,ACTUAL,2023-06-15,2021-12-30,ACTUAL,2021-12-30,,INTERVENTIONAL,,"Baseline characteristics were presented for Safety Population, all participants who received any amount of niraparib during the PK phase of study.",Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule,"An Open-Label, Randomized-Sequence, Multicenter, Single-Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Formulation Compared to Niraparib Capsule Formulation in Patients With Advanced Solid Tumors",COMPLETED,,PHASE1,236.0,ACTUAL,"Tesaro, Inc.",,6.0,,,,,,,f,t,f,,,,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf,YES,"GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf",2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,INDUSTRY,,,,,,,2023,1.0
NCT04167670,,2019-11-15,2022-03-09,,2022-03-09,2019-11-15,2019-11-19,ACTUAL,2022-03-09,2022-04-05,ACTUAL,,,,2022-03-09,2022-04-05,ACTUAL,2019-12-10,ACTUAL,2019-12-10,2022-03,2022-03-31,2021-03-18,ACTUAL,2021-03-18,2021-03-10,ACTUAL,2021-03-10,,INTERVENTIONAL,,Randomized Set - All participants randomly assigned to receive study drug regardless of whether or not they received a dose of study drug during the study.,Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection,A Phase 3 Randomized Multicenter Study to Evaluate the Efficacy and Safety of Open-Label Dual Therapy With Oral Vonoprazan 20 mg or Double-Blind Triple Therapy With Oral Vonoprazan 20 mg Compared to Double-Blind Triple Therapy With Oral Lansoprazole 30 mg Daily in Patients With Helicobacter Pylori Infection,COMPLETED,,PHASE3,1046.0,ACTUAL,"Phathom Pharmaceuticals, Inc.",,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,INDUSTRY,,,,,,,2021,1.0
NCT02960906,,2016-08-18,,,2021-04-22,2016-11-08,2016-11-10,ESTIMATED,,,,,,,2021-04-22,2021-04-26,ACTUAL,2017-05-31,ACTUAL,2017-05-31,2021-04,2021-04-30,2021-02-15,ACTUAL,2021-02-15,2021-02-15,ACTUAL,2021-02-15,,INTERVENTIONAL,BIONIKK,,A BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer,A Phase 2 BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer,COMPLETED,,PHASE2,200.0,ACTUAL,Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie,,8.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,OTHER,,,,,,,2021,1.0
NCT02489201,,2015-06-24,,,2023-06-13,2015-07-01,2015-07-02,ESTIMATED,,,,,,,2023-06-13,2023-06-15,ACTUAL,2015-07-21,ACTUAL,2015-07-21,2023-06,2023-06-30,2020-10-29,ACTUAL,2020-10-29,2020-10-29,ACTUAL,2020-10-29,,INTERVENTIONAL,,,A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer,A Phase 1B Study of Donafenib Monotherapy in Advanced Oesophageal Cancer Progressing After Chemotherapy,TERMINATED,,PHASE1/PHASE2,19.0,ACTUAL,"Suzhou Zelgen Biopharmaceuticals Co.,Ltd",,1.0,,Corporate policy adjustments,f,,,,f,f,f,,,,,,,,,,,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,INDUSTRY,,,,,,,2020,0.0
NCT05028361,,2021-08-30,2024-01-23,,2024-02-20,2021-08-30,2021-08-31,ACTUAL,2024-02-20,2024-03-19,ACTUAL,,,,2024-02-20,2024-03-19,ACTUAL,2021-10-04,ACTUAL,2021-10-04,2024-02,2024-02-29,2023-06-15,ACTUAL,2023-06-15,2023-03-03,ACTUAL,2023-03-03,,INTERVENTIONAL,,,Simultaneous mRNA COVID-19 and IIV4 Vaccination Study,"Safety of Simultaneous Versus Sequential Administration of mRNA COVID-19 Vaccines and Quadrivalent Inactivated Influenza (IIV4) in Adults, Adolescents and Children: A Randomized Observer Blinded Study",COMPLETED,,PHASE4,348.0,ACTUAL,Duke University,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 06:51:25.715979,2024-10-15 06:51:25.715979,OTHER,,,,,,,2023,1.0
NCT02930941,,2016-10-10,2021-08-24,,2021-11-03,2016-10-11,2016-10-12,ESTIMATED,2021-11-03,2021-11-30,ACTUAL,,,,2021-11-03,2021-11-30,ACTUAL,2016-02,,2016-02-29,2021-11,2021-11-30,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department,Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department,TERMINATED,,PHASE4,35.0,ACTUAL,"University of California, Davis",Coronavirus Disease 2019 (COVID-19) pandemic significantly impacted the ability to enroll patients; early termination leading to a small number of patients; single-center study;,2.0,,Terminate due to slow enrollment rate.,f,,,,t,t,,,,,,,,,,NO,,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,OTHER,,,,,,,2020,0.0
NCT03403517,,2018-01-05,2020-12-08,,2020-12-08,2018-01-11,2018-01-18,ACTUAL,2020-12-08,2021-01-05,ACTUAL,,,,2020-12-08,2021-01-05,ACTUAL,2017-12-11,ACTUAL,2017-12-11,2020-12,2020-12-31,2020-09-28,ACTUAL,2020-09-28,2020-08-28,ACTUAL,2020-08-28,,INTERVENTIONAL,STEREO,,Preoperative High Dose Steroids for Liver Resection- Effect on Complications in the Immediate Postoperative Period,"High Dose Steroids for Liver Resection - Effect on Complications and Endothelial Function in the Immediate Postoperative Phase - a Randomized, Doubleblind, Controlled Trial",COMPLETED,,PHASE4,174.0,ACTUAL,"Rigshospitalet, Denmark",,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,OTHER,,,,,,,2020,1.0
NCT02911467,,2016-09-19,,,2020-07-22,2016-09-20,2016-09-22,ESTIMATED,,,,,,,2020-07-22,2020-07-24,ACTUAL,2016-11-08,ACTUAL,2016-11-08,2020-07,2020-07-31,2020-07-20,ACTUAL,2020-07-20,2020-07-20,ACTUAL,2020-07-20,,INTERVENTIONAL,MR,,Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (HP) (13C) in Castration-Resistant Prostate Cancer,Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) as a Predictive Biomarker of Response to Androgen Signaling Inhibitors in Castration-Resistant Prostate Cancer,TERMINATED,,PHASE1,8.0,ACTUAL,"University of California, San Francisco",,1.0,,Low Accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,OTHER,,,,,,,2020,0.0
NCT04398134,,2020-05-18,2022-08-03,,2022-08-30,2020-05-18,2020-05-21,ACTUAL,2022-08-03,2022-08-26,ACTUAL,,,,2022-08-30,2022-09-15,ACTUAL,2020-08-28,ACTUAL,2020-08-28,2022-08,2022-08-31,2021-12-28,ACTUAL,2021-12-28,2021-10-14,ACTUAL,2021-10-14,,INTERVENTIONAL,,,A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection,"A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection",TERMINATED,,PHASE2,88.0,ACTUAL,Assembly Biosciences,"Study ABI-H2158-201 was terminated early due to alanine aminotransferase (ALT) elevations among study participants who received ABI-H2158 (and not among those who received PBO). Further details on these events are described in the results section below. In the absence of an alternative etiology for the ALT elevations, further clinical development of ABI-H2158 was terminated by the Sponsor.",2.0,,Study stopped due to a safety signal of drug-induced liver injury in subjects receiving 2158,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,INDUSTRY,,,,,,,2021,0.0
NCT04913675,,2021-05-27,2022-11-08,,2024-02-15,2021-06-02,2021-06-04,ACTUAL,2023-05-01,2023-05-26,ACTUAL,,,,2024-02-15,2024-03-07,ACTUAL,2021-06-10,ACTUAL,2021-06-10,2024-01,2024-01-31,2023-03-24,ACTUAL,2023-03-24,2022-07-19,ACTUAL,2022-07-19,,INTERVENTIONAL,,Baseline characteristics were reported for Safety Population for Main Study and Safety Sub-study.,Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.,"A Phase 3 Randomized, Multi-center, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Monoclonal Antibody VIR-7831 (Sotrovimab) Given Intramuscularly Versus Intravenously for the Treatment of Mild/Moderate Coronavirus Disease 2019 (COVID-19) in High-risk Non-hospitalized Patients; Safety Substudy Assessing the Safety and Tolerability of Single Ascending Dose Monoclonal Antibody VIR-7831",TERMINATED,,PHASE3,1065.0,ACTUAL,"Vir Biotechnology, Inc.","The pre-specified daily imputation resulted in overly high inflation in the estimated progression rates for missing data. To reduce this bias and to account for progression history, weekly imputation was used for final conclusions.",7.0,,The safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes,f,,,,t,t,f,,,,,,,,,,,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,INDUSTRY,,,,,,,2023,0.0
NCT03381833,,2017-12-12,,,2021-07-28,2017-12-20,2017-12-22,ACTUAL,,,,,,,2021-07-28,2021-07-29,ACTUAL,2017-11-30,ACTUAL,2017-11-30,2021-07,2021-07-31,2020-01-14,ACTUAL,2020-01-14,2019-12-03,ACTUAL,2019-12-03,,INTERVENTIONAL,,,A Study With LJPC-401 for the Treatment of Myocardial Iron Overload in Patients With Transfusion-Dependent Beta Thalassemia,"A Multi-Center, Randomized, Open-Label, Parallel-Group Study With LJPC-401 for the Treatment of Myocardial Iron Overload in Patients With Transfusion-Dependent Beta Thalassemia",TERMINATED,,PHASE2,84.0,ACTUAL,La Jolla Pharmaceutical Company,,2.0,,Terminated early for lack of efficacy as determined by interim endpoint analyses,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,INDUSTRY,,,,,,,2020,0.0
NCT05993143,,2023-08-08,,,2023-08-10,2023-08-10,2023-08-15,ACTUAL,,,,,,,2023-08-10,2023-08-15,ACTUAL,2021-01-18,ACTUAL,2021-01-18,2023-08,2023-08-31,2021-07-21,ACTUAL,2021-07-21,2021-07-21,ACTUAL,2021-07-21,,INTERVENTIONAL,,,Ivermectin to Prevent SARS-CoV-2 (COVID-19) Hospitalisation in Subjects Over 50,"A Multicentre, Phase III, Double-blind, Randomised, Parallel, Placebo-controlled Trial to Assess Efficacy and Safety of Early Administration of Ivermectin During 3 Consecutive Days to Prevent SARS CoV-2 (COVID-19) Hospitalisation in Adults Older Than 50 Years of Age",TERMINATED,,PHASE3,249.0,ACTUAL,Insud Pharma,,2.0,,"Study was stopped because no statistically significant difference was observed in the interim analysis. With high vaccine rates in those over 50 and an expected low incidence, it would not be feasible to complete recruitment within a short period.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,INDUSTRY,,,,,,,2021,0.0
NCT04487431,,2020-07-23,,,2023-01-24,2020-07-23,2020-07-27,ACTUAL,,,,,,,2023-01-24,2023-01-26,ACTUAL,2020-08-05,ACTUAL,2020-08-05,2023-01,2023-01-31,2021-02-11,ACTUAL,2021-02-11,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,,,A Trial to Learn How a New Liquid Form of BAY1817080 is Tolerated and Taken up by the Body of Healthy Male Participants (Part A). By Labeling BAY1817080 With a Radioactive Substance (Carbon 14) Researchers Want to Learn How the Study Drug is Processed and Excreted by the Body After Dosing (Part B),"Single-center, Open-label, Non-placebo-controlled, Single-dose Study in Healthy Male Participants to Determine the Pharmacokinetics of BAY 1817080 Oral Solution (Part A) and to Investigate the Pharmacokinetics, Metabolic Disposition and Mass Balance of [14C]BAY 1817080 Oral Solution (Part B)",COMPLETED,,PHASE1,14.0,ACTUAL,Bayer,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,There are no current plans to share data. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.,2024-10-15 18:03:23.937454,2024-10-15 18:03:23.937454,INDUSTRY,,,,,,,2021,1.0
NCT04115059,,2019-10-02,2022-04-01,,2023-09-12,2019-10-02,2019-10-03,ACTUAL,2023-09-12,2024-03-21,ACTUAL,,,,2023-09-12,2024-03-21,ACTUAL,2019-11-04,ACTUAL,2019-11-04,2023-09,2023-09-30,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Dasatinib In Waldenström Macroglobulinemia,Dasatinib in Patients With Waldenström Macroglobulinemia (WM) Progressing on Ibrutinib,TERMINATED,,PHASE1,3.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,Lack of efficacy,f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,OTHER,,,,,,,2021,0.0
NCT03852576,,2019-02-20,,,2022-11-17,2019-02-21,2019-02-25,ACTUAL,,,,,,,2022-11-17,2022-11-22,ACTUAL,2019-05-09,ACTUAL,2019-05-09,2022-11,2022-11-30,2020-11-18,ACTUAL,2020-11-18,2020-11-18,ACTUAL,2020-11-18,,INTERVENTIONAL,,,Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus,Phase 1B In-vivo Study of KSP/QRH Heptapeptide Dimer for Detection of Neoplasia in the Esophagus,TERMINATED,,PHASE1,38.0,ACTUAL,University of Michigan,,1.0,,Study had to be terminated for lack of dimer and inability to produce more at this time.,f,,,,t,t,f,,,,,,,,,YES,,2024-10-17 02:48:38.241354,2024-10-17 02:48:38.241354,OTHER,,,,,,,2020,0.0
NCT04601285,,2020-10-12,,,2023-07-04,2020-10-19,2020-10-23,ACTUAL,,,,,,,2023-07-04,2023-07-06,ACTUAL,2020-10-28,ACTUAL,2020-10-28,2023-07,2023-07-31,2023-06-14,ACTUAL,2023-06-14,2023-06-14,ACTUAL,2023-06-14,,INTERVENTIONAL,,,A Phase I Study of JS108 in Patients With Advanced Solid Tumors,"A Phase I, Open-label, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Recombinant Humanized Anti-Trop2 mAb-Tub196 Conjugate in Patients With Advanced Solid Tumors.",TERMINATED,,PHASE1,25.0,ACTUAL,"Shanghai Junshi Bioscience Co., Ltd.",,1.0,,Sponsor has adjusted study development plan and terminated this clinical study.,f,,,,,f,f,,,,,,,,,,,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,OTHER,,,,,,,2023,0.0
NCT02949934,,2016-10-26,2022-03-21,,2023-05-11,2016-10-27,2016-10-31,ESTIMATED,2022-03-21,2022-04-15,ACTUAL,,,,2023-05-11,2023-06-09,ACTUAL,2016-05-01,ACTUAL,2016-05-01,2023-05,2023-05-31,2021-04-13,ACTUAL,2021-04-13,2021-04-13,ACTUAL,2021-04-13,,INTERVENTIONAL,,Non-treatment-seeking individuals between the ages of 21 and 40 with DSM-5 diagnosed Alcohol Use Disorder.,"Effects of Cortical Dopamine Regulation on Drinking, Craving, and Cognitive Control",,COMPLETED,,PHASE2,90.0,ACTUAL,Medical University of South Carolina,,6.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,OTHER,,,,,,,2021,1.0
NCT04847921,,2021-04-13,,,2023-10-17,2021-04-13,2021-04-19,ACTUAL,,,,,,,2023-10-17,2023-10-19,ACTUAL,2021-04-30,ACTUAL,2021-04-30,2023-10,2023-10-31,2023-10-05,ACTUAL,2023-10-05,2023-10-05,ACTUAL,2023-10-05,,INTERVENTIONAL,SUDDEN-OUT,,Substance Use Disorder (SUD)-Associated Infections' Treatment With Dalbavancin ENabling OUtpatient Transition,Preliminary Evaluation of Dalbavancin's Efficacy in People Who Use Drugs With Severe Gram-positive Infections,TERMINATED,,PHASE2/PHASE3,11.0,ACTUAL,"University of Colorado, Denver",,1.0,,Delays in recruitment due to COVID-19 and higher than acceptable loss to followup.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,OTHER,,,,,,,2023,0.0
NCT03478878,,2018-03-21,2024-05-03,,2024-07-05,2018-03-24,2018-03-27,ACTUAL,2024-06-06,2024-07-03,ACTUAL,,,,2024-07-05,2024-07-30,ACTUAL,2018-05-14,ACTUAL,2018-05-14,2023-12,2023-12-31,2022-06-17,ACTUAL,2022-06-17,2022-06-17,ACTUAL,2022-06-17,,INTERVENTIONAL,,,Vitamin A Palmitate Supplementation in Patients With Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation,An Investigation of Vitamin A Palmitate Supplementation in Patients With Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation,COMPLETED,,EARLY_PHASE1,9.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,,f,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,NIH,,,,,,,2022,1.0
NCT03174522,,2017-05-31,,,2023-03-14,2017-06-01,2017-06-02,ACTUAL,,,,,,,2023-03-14,2023-03-16,ACTUAL,2017-04-25,ACTUAL,2017-04-25,2023-03,2023-03-31,2023-02-13,ACTUAL,2023-02-13,2023-02-13,ACTUAL,2023-02-13,,INTERVENTIONAL,,,The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM,"The Efficacy and Safety of Intra-arterial Administration of REX-001 to Treat Ischemic Ulcers in Subjects With Critical Limb Ischemia (CLI) Rutherford Category 5 and Diabetes Mellitus: A Pivotal, Placebo-controlled, Double-blind, Parallel-group, Adaptive Trial",TERMINATED,,PHASE3,49.0,ACTUAL,Ixaka Ltd,,2.0,,Independent Data Monitoring Committee recommendation to stop due to futility,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,INDUSTRY,,,,,,,2023,0.0
NCT03854227,,2019-02-15,,,2022-11-17,2019-02-22,2019-02-26,ACTUAL,,,,,,,2022-11-17,2022-11-22,ACTUAL,2019-03-14,ACTUAL,2019-03-14,2022-11,2022-11-30,2022-04-27,ACTUAL,2022-04-27,2022-04-27,ACTUAL,2022-04-27,,INTERVENTIONAL,,,A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors,"A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06939999 (PRMT5 INHIBITOR) IN PARTICIPANTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER, HEAD AND NECK SQUAMOUS CELL CARCINOMA, ESOPHAGEAL CANCER, ENDOMETRIAL CANCER, CERVICAL CANCER AND BLADDER CANCER",TERMINATED,,PHASE1,54.0,ACTUAL,Pfizer,,6.0,,The study has been terminated based on a strategic evaluation within the current Pfizer oncology portfolio. This decision is not due to any safety concerns or requests from any regulatory authorities.,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,INDUSTRY,,,,,,,2022,0.0
NCT03770455,,2018-10-05,2021-12-17,,2024-06-26,2018-12-07,2018-12-10,ACTUAL,2021-12-17,2022-01-18,ACTUAL,,,,2024-06-26,2024-07-09,ACTUAL,2019-01-25,ACTUAL,2019-01-25,2024-06,2024-06-30,2021-01-07,ACTUAL,2021-01-07,2020-12-17,ACTUAL,2020-12-17,,INTERVENTIONAL,,,Avelumab Plus 2nd-generation ADT in African American Subjects With mCRPC,PDL-1 Inhibition With Avelumab and Concurrent Second-generation ADT in African Americans With Castrate-resistant Metastatic Prostate Cancer,TERMINATED,,PHASE2,8.0,ACTUAL,Tulane University,"Study did not reach target number of participants needed to reach target power for statistically reliable results due to poor recruitment during Coronavirus Disease 2019 (COVID-19) pandemic and early termination of study.~Study closed early due to safety concerns regarding rapid clinical progression of several participants, therefore, the secondary outcome measures were not analyzed and no data was reported for those outcome measures, so they were deleted from the study record.",1.0,,Early signs of progression and learned experience that the assumed time period between psa progression and radiographic progression was shorter than expected,f,,,,f,t,f,,,,,,2022,To be determined pending publication,,YES,"all collected IPD, all IPD that underlie results in a publication",2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,OTHER,,,,,,,2021,0.0
NCT03624036,,2018-08-07,2022-02-14,,2023-10-31,2018-08-07,2018-08-09,ACTUAL,2022-05-06,2022-05-10,ACTUAL,,,,2023-10-31,2023-11-18,ACTUAL,2018-11-15,ACTUAL,2018-11-15,2023-10,2023-10-31,2022-11-18,ACTUAL,2022-11-18,2021-02-12,ACTUAL,2021-02-12,,INTERVENTIONAL,ZUMA-8,Safety Analysis Set included all participants who were treated with any dose of brexucabtagene autoleucel.,Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma,A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of KTE-X19 in Adult Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma,TERMINATED,,PHASE1,16.0,ACTUAL,Gilead Sciences,,5.0,,Development program terminated,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,INDUSTRY,,,,,,,2022,0.0
NCT04518410,,2020-08-17,2023-04-07,,2024-08-01,2020-08-18,2020-08-19,ACTUAL,2023-07-06,2023-07-27,ACTUAL,,,,2024-08-01,2024-08-02,ACTUAL,2020-08-19,ACTUAL,2020-08-19,2024-08,2024-08-31,2023-06-20,ACTUAL,2023-06-20,2022-04-07,ACTUAL,2022-04-07,,INTERVENTIONAL,,Total MITT Population=Randomized and Treated and included in analysis = All with Randomization Date - Randomized Not Treated-Randomized screen failed - Excluded from analysis - Dual enrollment = 4044 - 54 - 2 - 252 - 1~All participants were considered to be separately enrolled participants for subsequent phases of the study.~BRII arms included pooled participants from Phase 2/Phase 3 to complete a Phase 3 analysis.,ACTIV-2: A Study for Outpatients With COVID-19,Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID),COMPLETED,,PHASE2/PHASE3,4044.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,25.0,,,f,,,,t,t,f,,,,,,,NIAID OCICB requires a Data Use Agreement be signed by investigators seeking to obtain the PUD.,https://accessclinicaldata.niaid.nih.gov/study-viewer/clinical_trials,YES,"Individual patient level data are available from ACTIV-2 clinical trial in accessclinicaldata@NIAID, a NIAID cloud-based secure controlled access data platform that enables sharing of and access to data sets from clinical trials for basic and clinical research and requires a data access request and a signed data use agreement.",2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,NIH,,,,,,,2023,1.0
NCT03634150,,2018-06-20,,,2021-10-18,2018-08-14,2018-08-16,ACTUAL,,,,,,,2021-10-18,2021-10-26,ACTUAL,2018-09-06,ACTUAL,2018-09-06,2021-10,2021-10-31,2020-04-21,ACTUAL,2020-04-21,2020-04-21,ACTUAL,2020-04-21,,INTERVENTIONAL,,,"Safety and Efficacy of IV Nerofe™ Followed by Doxorubicin, In Metastatic Ovarian Cancer and Triple Negative Breast Cancer","A Phase 1b, Open-Label, Dose-Confirmation Study Evaluating the Safety, and Clinical Effects of Intravenously Administered Nerofe™ in Combination With Doxorubicin, In Subjects With Metastatic Ovarian Cancer and Triple Negative Breast Cancer",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Immune System Key Ltd,,1.0,,Patients were screened but not enrolled,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,INDUSTRY,,,,,,,2020,0.0
NCT03759184,,2018-11-28,2022-02-15,,2022-03-11,2018-11-28,2018-11-29,ACTUAL,2022-02-15,2022-03-10,ACTUAL,,,,2022-03-11,2022-03-22,ACTUAL,2019-07-11,ACTUAL,2019-07-11,2022-03,2022-03-31,2021-10-22,ACTUAL,2021-10-22,2019-12-15,ACTUAL,2019-12-15,,INTERVENTIONAL,,,Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocyte Leukemia,Phase 1 Trial of Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocyte Leukemia,TERMINATED,,PHASE1,1.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,The study was closed after \> 1 year of inactivity.,f,,,,f,t,f,,,,,,Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genome Data Sharing (GDS) plan for as long as database is active.,Clinical data will be made available via subscription to Biomedical Translational Research (BTRIS) and with the permission of the study principal investigator (PI).~Genomic data are made available via database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.,,YES,All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,NIH,,,,,,,2021,0.0
NCT02827968,,2016-06-29,,,2021-05-31,2016-07-06,2016-07-11,ESTIMATED,,,,,,,2021-05-31,2021-06-02,ACTUAL,2017-01-13,ACTUAL,2017-01-13,2021-03,2021-03-31,2020-12,ACTUAL,2020-12-31,2020-08,ACTUAL,2020-08-31,,INTERVENTIONAL,,,Phase 1 Study of Anti-PD-L1 Monoclonal Antibody KN035 to Treat Locally Advanced or Metastatic Solid Tumors,"A Phase I, Open Label, Dose Escalation Study of The Safety and Pharmacokinetics of Anti-PD-L1 Monoclonal Antibody KN035 Administered in Subcutaneous Injection as A Single Agent to Subjects With Locally Advanced or Metastatic Solid Tumors",COMPLETED,,PHASE1,28.0,ACTUAL,3D Medicines,,1.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,INDUSTRY,,,,,,,2020,1.0
NCT04441398,,2020-06-18,,,2022-10-26,2020-06-19,2020-06-22,ACTUAL,,,,,,,2022-10-26,2022-10-28,ACTUAL,2020-07,ESTIMATED,2020-07-31,2022-10,2022-10-31,2020-09,ESTIMATED,2020-09-30,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients,"Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg to Treat Ambulatory Adult Subjects Diagnosed With COVID-19 With Mild Symptoms Assisted in the Public Health System of the City of Mesquita",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Azidus Brasil,,2.0,,Sponsor's strategic decision,f,,,,f,f,f,,,,,,,,,NO,"It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.",2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,INDUSTRY,,,,,,,2020,0.0
NCT04925934,,2021-05-04,2024-06-07,2024-02-26,2024-07-21,2021-06-08,2021-06-14,ACTUAL,2024-07-21,2024-07-23,ACTUAL,,2024-07-23,ACTUAL,2024-07-21,2024-07-23,ACTUAL,2021-05-28,ACTUAL,2021-05-28,2024-07,2024-07-31,2023-06-09,ACTUAL,2023-06-09,2023-05-16,ACTUAL,2023-05-16,,INTERVENTIONAL,RECAST SLE,Full analysis set (FAS): included all randomized participants who received any dose of investigational product (IP). Participants were analyzed according to the treatment randomized.,Study of VIB7734 for the Treatment of Moderate to Severely Active SLE,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus",COMPLETED,,PHASE2,214.0,ACTUAL,Amgen,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,INDUSTRY,,,,,,,2023,1.0
NCT04269395,,2020-02-10,2023-05-27,,2023-09-15,2020-02-12,2020-02-13,ACTUAL,2023-09-15,2023-10-10,ACTUAL,,,,2023-09-15,2023-10-10,ACTUAL,2020-04-07,ACTUAL,2020-04-07,2023-09,2023-09-30,2021-09-01,ACTUAL,2021-09-01,2021-09-01,ACTUAL,2021-09-01,,INTERVENTIONAL,,Safety population consisted of all enrolled participants and was to be used for all efficacy and safety analyses.,A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study,"A Double-blind, Multicenter, Long-term Follow-up Study to Assess Recurrence of Actinic Keratosis in Subjects Treated With Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) or Vehicle Cream in the Treatment of Thin and Moderately Thick, Non-hyperkeratotic, Non-pigmented Actinic Keratosis of the Face and Scalp When Using Daylight Photodynamic Therapy (DL-PDT), for Subjects Achieving Complete Response of Treated Lesions at Final Visit in Study RD.06.SPR.112199",TERMINATED,,PHASE3,125.0,ACTUAL,Galderma R&D,"This LTFU study was terminated early by the Sponsor because in the main study RD.06.SPR.112199, the primary analysis did not show superiority of MAL 16.8% cream with DL-PDT over vehicle cream with DL-PDT in terms of participant complete response (CR), and the sponsor decided not to apply for marketing authorization for the MAL 16.8% cream in combination with DL-PDT.",2.0,,The study was terminated early as per Sponsor's decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,INDUSTRY,,,,,,,2021,0.0
NCT05730673,,2023-02-07,,,2023-02-15,2023-02-07,2023-02-16,ACTUAL,,,,,,,2023-02-15,2023-02-17,ACTUAL,2022-09-20,ESTIMATED,2022-09-20,2023-02,2023-02-28,2023-08-10,ESTIMATED,2023-08-10,2023-05-27,ESTIMATED,2023-05-27,,INTERVENTIONAL,,,"Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer","A Phase II Study of Leronlimab (PRO 140) in Combination With Regorafenib in Patients With CCR5+, Microsatellite Stable (MSS), Metastatic Colorectal Cancer (mCRC)",WITHDRAWN,,PHASE2,0.0,ACTUAL,"CytoDyn, Inc.",,1.0,,No participants enrolled,f,,,,t,t,f,,,,,,,,,,,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,INDUSTRY,,,,,,,2023,0.0
NCT04964388,,2021-07-07,2024-05-17,,2024-06-26,2021-07-07,2021-07-16,ACTUAL,2024-06-26,2024-07-24,ACTUAL,,,,2024-06-26,2024-07-24,ACTUAL,2021-11-09,ACTUAL,2021-11-09,2024-06,2024-06-30,2023-07-01,ACTUAL,2023-07-01,2023-05-01,ACTUAL,2023-05-01,,INTERVENTIONAL,,,Effect of GLP-1 Receptor Agonists on Trabecular Bone Score,Effect of GLP-1 Receptor Agonists on Trabecular Bone Score and Visceral Adiposity in Postmenopausal Women With Type 2 Diabetes Mellitus.,TERMINATED,,PHASE2,5.0,ACTUAL,University of Mississippi Medical Center,,2.0,,Not able to recruit participants,f,,,,f,t,f,,,f,,,,,,NO,No sharing,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,OTHER,,,,,,,2023,0.0
NCT03969420,,2019-05-29,2022-06-09,,2023-11-07,2019-05-29,2019-05-31,ACTUAL,2022-09-22,2022-10-19,ACTUAL,,,,2023-11-07,2023-11-09,ACTUAL,2020-01-15,ACTUAL,2020-01-15,2023-11,2023-11-30,2021-05-14,ACTUAL,2021-05-14,2021-04-22,ACTUAL,2021-04-22,,INTERVENTIONAL,,,Study of Alvocidib in Patients With Relapsed/Refractory AML Following Treatment With Venetoclax Combination Therapy,"A Phase 2, Open-label, Randomized, Two-stage Clinical Study of Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia Following Treatment With Venetoclax Combination Therapy",TERMINATED,,PHASE2,11.0,ACTUAL,"Sumitomo Pharma America, Inc.",,4.0,,"Business decision to terminate the development of alvocidib program on 17 November 2020. Patients permitted on treatment until April 22, 2021. The last end-of-treatment follow-up completed on May 14, 2021.",f,,,,f,t,f,,,,,,,,,,,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,INDUSTRY,,,,,,,2021,0.0
NCT03123588,,2017-04-17,2021-08-02,,2021-10-21,2017-04-19,2017-04-21,ACTUAL,2021-10-21,2021-11-19,ACTUAL,,,,2021-10-21,2021-11-19,ACTUAL,2017-11-14,ACTUAL,2017-11-14,2021-10,2021-10-31,2020-08-03,ACTUAL,2020-08-03,2020-08-03,ACTUAL,2020-08-03,,INTERVENTIONAL,,,Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272),"A Double-Blind, Double-Dummy Phase 2 Randomized Study to Evaluate the Efficacy and Safety of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)",TERMINATED,,PHASE2,12.0,ACTUAL,Incyte Corporation,,2.0,,Enrollment issues,t,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,INDUSTRY,,NCT03147742,APPROVED_FOR_MARKETING,,,,2020,0.0
NCT03235180,,2017-07-27,2021-10-15,,2021-10-15,2017-07-31,2017-08-01,ACTUAL,2021-10-15,2021-11-10,ACTUAL,,,,2021-10-15,2021-11-10,ACTUAL,2017-06-16,ACTUAL,2017-06-16,2021-10,2021-10-31,2021-10-12,ACTUAL,2021-10-12,2021-10-12,ACTUAL,2021-10-12,,INTERVENTIONAL,,,Ultrasound Evaluation of Crohn's Disease,Ultrasound Evaluation of Crohn's Disease,TERMINATED,,PHASE4,9.0,ACTUAL,Mayo Clinic,,1.0,,Unable to secure funding.,f,,,,f,f,t,,,f,,,,,,NO,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,OTHER,,,,,,,2021,0.0
NCT04740970,,2021-02-03,,,2021-04-29,2021-02-03,2021-02-05,ACTUAL,,,,,,,2021-04-29,2021-05-04,ACTUAL,2021-03-24,ESTIMATED,2021-03-24,2021-04,2021-04-30,2022-07-20,ESTIMATED,2022-07-20,2022-06-02,ESTIMATED,2022-06-02,,INTERVENTIONAL,,,A Study of JNJ-64304500 in Participants With Alopecia Areata,"A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-64304500 in Patients With Alopecia Areata",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,Sponsor Decision.,f,,,,t,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,INDUSTRY,,,,,,,2022,0.0
NCT04137887,,2019-10-11,2023-03-30,,2023-05-11,2019-10-22,2019-10-24,ACTUAL,2023-05-11,2023-06-08,ACTUAL,,,,2023-05-11,2023-06-08,ACTUAL,2019-11-04,ACTUAL,2019-11-04,2023-05,2023-05-31,2020-05-31,ACTUAL,2020-05-31,2020-05-31,ACTUAL,2020-05-31,,INTERVENTIONAL,,Analysis was performed on all vaccinated participants.,Study to Evaluate the Effectiveness of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Adults 65 Years of Age and Older,Relative Effectiveness of a High-Dose Quadrivalent Influenza Vaccine Versus a Standard-Dose Quadrivalent Influenza Vaccine in Subjects 65 Years of Age and Older,TERMINATED,,PHASE3,33096.0,ACTUAL,Sanofi,"COVID-19 severely impacted the study resulting in low influenza circulation and disruption of trial recruitment for subsequent seasons (no enrollment done for seasons 2020-21 \& 2021-22). Moreover, the events collected as primary outcomes could have been driven by COVID cases, diluting the effect of influenza vaccines on such events. The study was prematurely terminated.",2.0,,Enrollment terminated due to the COVID-19 pandemic,f,,,,t,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,INDUSTRY,,,,,,,2020,0.0
NCT04403282,,2020-05-21,,,2024-01-29,2020-05-26,2020-05-27,ACTUAL,,,,,,,2024-01-29,2024-01-31,ACTUAL,2020-09-27,ACTUAL,2020-09-27,2024-01,2024-01-31,2023-06-22,ACTUAL,2023-06-22,2023-06-22,ACTUAL,2023-06-22,,INTERVENTIONAL,,,Topical Eflornithine for Pseudofolliculitis Barbae: Randomized Controlled Trial,"Topical Eflornithine Hydrochloride for Pseudofolliculitis Barbae: A Randomized, Double-blinded, Placebo-controlled Trial",TERMINATED,,PHASE4,9.0,ACTUAL,Walter Reed National Military Medical Center,,2.0,,Vaniqa no longer manufactured,f,,,,f,t,f,,,t,,,,,,NO,"The PI will compile the names of the patients who are followed through week 16 in order to create the master subject list. Using the information stored on the master subject list (name, social security number, Medical Record Number), the research team will obtain data electronically from the patient medical records. Specifically, the lesion and hair counts on the face will be acquired. This will be recorded on the master data sheet. The master subject list will be password protected and only accessible to study personnel within the Walter Reed National Military Medical Center (WRNMMC) network. The master data sheet will be coded and available to the investigators and may be shared with research assistants or statisticians.",2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,FED,,,,,,,2023,0.0
NCT03988647,,2019-06-13,2021-07-07,,2021-08-05,2019-06-13,2019-06-17,ACTUAL,2021-08-05,2021-08-09,ACTUAL,,,,2021-08-05,2021-08-09,ACTUAL,2019-07-24,ACTUAL,2019-07-24,2021-08,2021-08-31,2021-01-20,ACTUAL,2021-01-20,2020-11-16,ACTUAL,2020-11-16,,INTERVENTIONAL,,,Palliative RT & Anti-PD-1/PD-L1 Checkpoint Blockade in Metastatic Merkel Cell Carcinoma,A Phase 2 Study of Palliative Radiation Therapy and Anti-PD-1/PD-L1 Checkpoint Blockade in Patients With Metastatic Merkel Cell Carcinoma,TERMINATED,,PHASE2,1.0,ACTUAL,Stanford University,,1.0,,Business decision,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,OTHER,,,,,,,2021,0.0
NCT02119000,,2014-01-26,,,2021-02-22,2014-04-17,2014-04-21,ESTIMATED,,,,,,,2021-02-22,2021-02-24,ACTUAL,2015-08,,2015-08-31,2021-02,2021-02-28,2020-01,ACTUAL,2020-01-31,2020-01,ACTUAL,2020-01-31,,INTERVENTIONAL,,,Comparison of Two Types of Bowel Preparation for Inpatient Colonoscopy,,TERMINATED,,PHASE4,82.0,ACTUAL,McGill University Health Centre/Research Institute of the McGill University Health Centre,,2.0,,Difficulty in recruitment,f,,,,f,,,,,,,,,,,,,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,OTHER,,,,,,,2020,0.0
NCT05084456,,2019-03-25,,,2021-10-18,2021-10-18,2021-10-19,ACTUAL,,,,,,,2021-10-18,2021-10-19,ACTUAL,2017-07,ESTIMATED,2017-07-31,2021-10,2021-10-31,2020-04,ESTIMATED,2020-04-30,2020-02,ESTIMATED,2020-02-29,,INTERVENTIONAL,,,Oral Docetaxel in Patients With Normal or Impaired Liver Function,Weekly Administration of (bi-)Daily Oral Docetaxel in Combination With Ritonavir in Patients With Normal or Impaired Liver Function,WITHDRAWN,,PHASE1,0.0,ACTUAL,Modra Pharmaceuticals,,3.0,,Pending further development,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 02:55:33.932217,2024-10-17 02:55:33.932217,INDUSTRY,,,,,,,2020,0.0
NCT03417401,,2017-11-20,,,2023-03-22,2018-01-24,2018-01-31,ACTUAL,,,,,,,2023-03-22,2023-03-23,ACTUAL,2018-10-16,ESTIMATED,2018-10-16,2023-03,2023-03-31,2021-12-10,ACTUAL,2021-12-10,2021-12-10,ACTUAL,2021-12-10,,INTERVENTIONAL,,,Surgical Stabilizer Assisted RVC With rtPA for CRVO,Phase Ib Study on Surgical Stabilizer Assisted Retinal Vein Cannulation (RVC) With tPA Infusion Confirmed by Intraoperative Angio-optical Coherence Tomography (Angio-OCT) for the Treatment of Central Retinal Vein Occlusion (CRVO).,WITHDRAWN,,PHASE1,0.0,ACTUAL,Universitaire Ziekenhuizen KU Leuven,,1.0,,organizationally not yet possible,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,OTHER,,,,,,,2021,0.0
NCT03854032,,2019-02-21,,,2024-07-25,2019-02-21,2019-02-26,ACTUAL,,,,,,,2024-07-25,2024-07-29,ACTUAL,2019-04-09,ACTUAL,2019-04-09,2024-07,2024-07-31,2024-06-12,ACTUAL,2024-06-12,2024-06-12,ACTUAL,2024-06-12,,INTERVENTIONAL,,,Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck,Window-of-Opportunity Trial of Nivolumab and BMS986205 in Patients With Squamous Cell Carcinoma of the Head and Neck (CA017-087),TERMINATED,,PHASE2,45.0,ACTUAL,Thomas Jefferson University,,2.0,,toxicity - per sponsor,f,,,,t,t,f,,,,,,,,,,,2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,OTHER,,,,,,,2024,0.0
NCT03780725,,2018-11-26,,,2021-11-03,2018-12-18,2018-12-19,ACTUAL,,,,,,,2021-11-03,2021-11-05,ACTUAL,2019-01-22,ACTUAL,2019-01-22,2021-11,2021-11-30,2020-12-08,ACTUAL,2020-12-08,2020-02-19,ACTUAL,2020-02-19,,INTERVENTIONAL,,,This Study Tests How BI 754111 is Distributed in Patients With Advanced Non-small Cell Lung Cancer or Patients With Head and Neck Cancer Who Are Treated With BI 754091,An Open Label Phase I PET Imaging Study to Investigate the Bio-distribution and Tumor Uptake of [89Zr]Zr-BI 754111 in Patients With Advanced Non-small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma Treated With BI 754111 in Combination With BI 754091,TERMINATED,,PHASE1,8.0,ACTUAL,Boehringer Ingelheim,,2.0,,Due to company decision.,f,,,,f,f,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,INDUSTRY,,,,,,,2020,0.0
NCT04328285,,2020-03-25,,,2023-02-28,2020-03-27,2020-03-31,ACTUAL,,,,,,,2023-02-28,2023-03-01,ACTUAL,2020-04-14,ACTUAL,2020-04-14,2023-02,2023-02-28,2022-03-30,ACTUAL,2022-03-30,2020-05-13,ACTUAL,2020-05-13,,INTERVENTIONAL,COVIDAXIS,,Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers,Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers : A Randomized Double-blind Placebo-controlled Clinical Trial,TERMINATED,,PHASE3,118.0,ACTUAL,Centre Hospitalier Universitaire de Saint Etienne,,2.0,,French authority's decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,OTHER,,,,,,,2022,0.0
NCT04488185,,2020-06-26,,,2023-03-28,2020-07-23,2020-07-27,ACTUAL,,,,,,,2023-03-28,2023-03-31,ACTUAL,2020-11-02,ACTUAL,2020-11-02,2023-03,2023-03-31,2021-03-24,ACTUAL,2021-03-24,2021-03-24,ACTUAL,2021-03-24,,INTERVENTIONAL,INTERCEPT,,An Efficacy Study of Secukinumab in Plaque Psoriasis Patients With Subclinical Psoriatic Arthritis as Measured by Musculoskeletal Ultrasound,"An Exploratory, Randomized, Double-blind, Parallel-group, Multicenter Study to Compare Secukinumab 300 mg With Placebo After 16 Weeks of Treatment in Adults With Moderate to Severe Plaque Psoriasis and Subclinical Enthesitis Measured by Musculoskeletal Ultrasound",WITHDRAWN,,PHASE4,0.0,ACTUAL,Novartis,,2.0,,low recruitment,f,,,,f,t,f,,,,,,,,,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,INDUSTRY,,,,,,,2021,0.0
NCT03345004,,2017-11-01,2021-11-23,,2022-04-11,2017-11-13,2017-11-17,ACTUAL,2022-04-11,2023-01-09,ACTUAL,,,,2022-04-11,2023-01-09,ACTUAL,2017-12-20,ACTUAL,2017-12-20,2022-04,2022-04-30,2021-04-27,ACTUAL,2021-04-27,2020-07-13,ACTUAL,2020-07-13,,INTERVENTIONAL,,,Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes,"A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd Therapy Administered Into Lymph Nodes Combined With Oral Vitamin D to Investigate the Impact on the Progression of Type 1 Diabetes",COMPLETED,,PHASE2,109.0,ACTUAL,Diamyd Medical AB,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,INDUSTRY,,,,,,,2021,1.0
NCT00061282,,2003-05-23,,,2022-12-07,2003-05-23,2003-05-26,ESTIMATED,,,,,,,2022-12-07,2022-12-09,ACTUAL,2002-09-30,ACTUAL,2002-09-30,2022-12,2022-12-31,2020-12-01,ACTUAL,2020-12-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,CAPTURE,,Clotrimazole Enemas for Pouchitis in Children and Adults,Clotrimazole Enemas for Pouchitis in Children and Adults,TERMINATED,,PHASE1/PHASE2,11.0,ACTUAL,Boston Children's Hospital,,3.0,,Funding Horizon,f,,,,t,,,,,,,,,,,,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,OTHER,,,,,,,2020,0.0
NCT04946318,,2021-06-23,,,2022-10-07,2021-06-23,2021-06-30,ACTUAL,,,,,,,2022-10-07,2022-10-10,ACTUAL,2021-09-08,ACTUAL,2021-09-08,2022-10,2022-10-31,2022-09-08,ACTUAL,2022-09-08,2022-09-08,ACTUAL,2022-09-08,,INTERVENTIONAL,,,Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma,"A 24-week, Multicenter, Randomized, Double-blind, Parallel-arm, Placebo-controlled Extension Study to Assess the Safety of CSJ117, When Added to Existing Standard of Care Asthma Therapy in Patients ≥18 Years of Age",TERMINATED,,PHASE2,136.0,ACTUAL,Novartis,,6.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,INDUSTRY,,,,,,,2022,0.0
NCT04915950,,2021-06-01,2023-08-30,,2023-12-01,2021-06-01,2021-06-07,ACTUAL,2023-12-01,2023-12-22,ACTUAL,,,,2023-12-01,2023-12-22,ACTUAL,2021-11-03,ACTUAL,2021-11-03,2023-12,2023-12-31,2022-09-02,ACTUAL,2022-09-02,2022-09-02,ACTUAL,2022-09-02,,INTERVENTIONAL,,"The full analysis set (FAS) included all randomized participants, irrespective of whether they received any study treatment.",A Study to Assess the Effect of Oral Temanogrel on Digital Blood Flow in Adult Participants With Raynaud's Phenomenon Secondary to Systemic Sclerosis,"A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Effect of Oral Temanogrel on Digital Blood Flow in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis",TERMINATED,,PHASE2,13.0,ACTUAL,Pfizer,This study was terminated early due to a business decision that was not due to any safety concerns. The number of participants was smaller than originally planned and only summary statistics were therefore generated for primary and secondary outcome measures.,6.0,,Business decision,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,INDUSTRY,,,,,,,2022,0.0
NCT04872101,,2021-04-29,,,2023-01-06,2021-04-29,2021-05-04,ACTUAL,,,,,,,2023-01-06,2023-01-09,ACTUAL,2021-05-25,ACTUAL,2021-05-25,2023-01,2023-01-31,2023-01-06,ACTUAL,2023-01-06,2022-12-27,ACTUAL,2022-12-27,,INTERVENTIONAL,DELTA 2,,Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2),A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 2),COMPLETED,,PHASE3,473.0,ACTUAL,LEO Pharma,,2.0,,,f,,,,f,f,f,,,,,,Data is available to request after results of the trial are available on leopharmatrials.com,Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.,http://leopharmatrials.com/for-professionals,YES,De-identified IPD can be made available to researchers in a closed environment for a specified period of time.,2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,INDUSTRY,,,,,,,2023,1.0
NCT03418480,,2017-11-15,,,2024-02-06,2018-01-31,2018-02-01,ACTUAL,,,,,,,2024-02-06,2024-02-07,ACTUAL,2017-04-11,ACTUAL,2017-04-11,2024-02,2024-02-29,2024-01-24,ACTUAL,2024-01-24,2023-11-01,ACTUAL,2023-11-01,,INTERVENTIONAL,HARE-40,,HARE-40: HPV Anti-CD40 RNA vaccinE,Therapeutic HPV Vaccine (BNT113) Trial in HPV16 Driven Carcinoma,COMPLETED,,PHASE1/PHASE2,32.0,ACTUAL,University of Southampton,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,OTHER,,,,,,,2024,0.0
NCT04776876,,2021-02-08,,,2021-09-23,2021-02-25,2021-03-02,ACTUAL,,,,,,,2021-09-23,2021-09-29,ACTUAL,2021-03-01,ESTIMATED,2021-03-01,2021-09,2021-09-30,2021-09-02,ACTUAL,2021-09-02,2021-09-02,ACTUAL,2021-09-02,,INTERVENTIONAL,,,Retifanlimab (INCMGA00012) and Telotristat Ethyl for the Treatment of Advanced Neuroendocrine Tumors and Carcinoid Syndrome,"A Phase II, Open-Label, Single-Arm Study of INCMGA00012 and Telotristat Ethyl in Patients With Advanced Neuroendocrine Tumors and Carcinoid Syndrome",WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,The study will not be opening. Support was withdrawn.,f,,,,t,t,f,,,,,,,,,,,2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,OTHER,,,,,,,2021,0.0
NCT04748588,,2021-02-08,,,2023-04-14,2021-02-08,2021-02-10,ACTUAL,,,,,,,2023-04-14,2023-04-19,ACTUAL,2021-02-12,ACTUAL,2021-02-12,2021-01,2021-01-31,2022-01-31,ACTUAL,2022-01-31,2022-01-31,ACTUAL,2022-01-31,,INTERVENTIONAL,CATCO-NOS,,Treatment of Nosocomial COVID-19,Canadian Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of Nosocomial Acquired COVID-19 Patients,TERMINATED,,PHASE4,46.0,ACTUAL,University of Calgary,,2.0,,Equipoise requirement no longer met.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,OTHER,,,,,,,2022,0.0
NCT03362593,,2017-11-22,,,2020-08-27,2017-12-04,2017-12-05,ACTUAL,,,,,,,2020-08-27,2020-08-31,ACTUAL,2017-12-04,ACTUAL,2017-12-04,2020-08,2020-08-31,2020-05-11,ACTUAL,2020-05-11,2020-05-11,ACTUAL,2020-05-11,,INTERVENTIONAL,,,"A 6-Part Study In Healthy Volunteers To Evaluate Safety, Tolerability and Uptake Of MEDI7219 in the Body When Given as Single and Multiple Doses","A Phase 1 Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI7219 in Healthy Subjects, Including Assessment of the Impact of Changes to the Oral Formulation and Determination of Intravenous Pharmacokinetics",TERMINATED,,PHASE1,186.0,ACTUAL,MedImmune LLC,,3.0,,The program is canceled due to company strategic reasons.,f,,,,f,f,f,,,,,,AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.,"When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ standards.,2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,INDUSTRY,,,,,,,2020,0.0
NCT03562507,,2018-06-08,2023-10-05,,2024-05-17,2018-06-08,2018-06-19,ACTUAL,2024-05-17,2024-05-20,ACTUAL,,,,2024-05-17,2024-05-20,ACTUAL,2019-04-11,ACTUAL,2019-04-11,2024-05,2024-05-31,2022-10-18,ACTUAL,2022-10-18,2022-10-18,ACTUAL,2022-10-18,,INTERVENTIONAL,ERICA,No patients were enrolled in the ESK984 and Nivolumab combo arm,Multi-center Trial of ESK981 in Combination With Nivolumab in Patients With Metastatic Renal Cell Carcinoma,ERICA: Phase 2 Multi-center Trial of ESK981 in Combination With Nivolumab in Patients With Metastatic Renal Cell Carcinoma,TERMINATED,,PHASE2,8.0,ACTUAL,University of Michigan Rogel Cancer Center,,2.0,,Lack of patient population,f,,,,,t,f,,,,,,,,,NO,,2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,OTHER,,,,,,,2022,0.0
NCT03580187,,2018-06-14,,,2022-09-21,2018-07-02,2018-07-09,ACTUAL,,,,,,,2022-09-21,2022-09-23,ACTUAL,2018-06-14,ACTUAL,2018-06-14,2022-09,2022-09-30,2020-04-15,ACTUAL,2020-04-15,2020-04-15,ACTUAL,2020-04-15,,INTERVENTIONAL,,,Nebulized Morphine in Chest Trauma Patients: A Prospective Study,Nebulized Morphine in Chest Trauma Patients: A Prospective Study,COMPLETED,,PHASE3,75.0,ACTUAL,"University Hospital, Mahdia",,1.0,,,f,,,,f,f,f,,,f,,,,,,UNDECIDED,,2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,OTHER,,,,,,,2020,1.0
NCT02582996,,2015-03-31,,,2019-04-09,2015-10-20,2015-10-21,ESTIMATED,,,,,,,2019-04-09,2019-04-10,ACTUAL,2020-04,ESTIMATED,2020-04-30,2019-04,2019-04-30,2021-06,ESTIMATED,2021-06-30,2021-04,ESTIMATED,2021-04-30,,INTERVENTIONAL,,,Cefalium® Compared to Tylenol® in the Treatment of Migraine Attacks,"National, Phase III, Multicenter, Randomized, Open, Parallel, to Evaluate the Efficacy, Safety and Superiority of Cefalium® Compared to the Tylenol® in the Treatment of Migraine Attacks",SUSPENDED,,PHASE3,336.0,ESTIMATED,Ache Laboratorios Farmaceuticos S.A.,,2.0,,Strategic reasons of the company,f,,,,f,f,f,,,,,,,,,,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,INDUSTRY,,,,,,,2021,0.0
NCT03554109,,2018-05-25,,,2022-03-28,2018-06-11,2018-06-12,ACTUAL,,,,,,,2022-03-28,2022-04-05,ACTUAL,2018-09,ESTIMATED,2018-09-30,2018-08,2018-08-31,2021-12,ESTIMATED,2021-12-31,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,TNBC,,QUILT-3.057: NANT Neoadjuvant Triple- Negative Breast Cancer (TNBC) Vaccine,An Open-Label Randomized Phase 2 Trial Of The NANT NEOADJUVANT Triple-Negative Breast Cancer (TNBC) VACCINE VS Standard-Of-Care For The Neoadjuvant Treatment Of Subjects With TNBC,WITHDRAWN,,PHASE2,0.0,ACTUAL,"ImmunityBio, Inc.",,2.0,,Trial not initiated,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,INDUSTRY,,,,,,,2021,0.0
NCT02077621,,2014-02-24,,,2023-11-23,2014-03-02,2014-03-04,ESTIMATED,,,,,,,2023-11-23,2023-11-27,ACTUAL,2014-02,ESTIMATED,2014-02-28,2023-11,2023-11-30,2020-12,ACTUAL,2020-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer,The Phase II Clinical Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,PhytoHealth Corporation,,2.0,,Study reevaluation,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,INDUSTRY,,,,,,,2020,0.0
NCT04565327,,2020-09-21,2023-10-18,,2023-10-18,2020-09-21,2020-09-25,ACTUAL,2023-10-18,2023-11-13,ACTUAL,,,,2023-10-18,2023-11-13,ACTUAL,2020-08-14,ACTUAL,2020-08-14,2023-10,2023-10-31,2022-11-01,ACTUAL,2022-11-01,2022-11-01,ACTUAL,2022-11-01,,INTERVENTIONAL,,No participants were assigned to Cohort A,Hyperpolarized 13C Pyruvate MRI for Treatment Response Assessment in Pancreatic Ductal Adenocarcinoma,Hyperpolarized 13C Pyruvate MRI for Treatment Response Assessment in Pancreatic Ductal Adenocarcinoma,TERMINATED,,PHASE2,7.0,ACTUAL,"University of California, San Francisco",Study closed earlier than expected due to slow accrual,2.0,,Slow accrual,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,OTHER,,,,,,,2022,0.0
NCT04604132,,2020-10-21,2023-11-21,,2024-03-06,2020-10-21,2020-10-27,ACTUAL,2024-03-06,2024-04-04,ACTUAL,,,,2024-03-06,2024-04-04,ACTUAL,2020-10-06,ACTUAL,2020-10-06,2024-03,2024-03-31,2022-11-21,ACTUAL,2022-11-21,2022-11-21,ACTUAL,2022-11-21,,INTERVENTIONAL,FIDES-03,,"Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma","A Phase 1b/2 Study of Derazantinib as Monotherapy and Combination Therapy With Paclitaxel, Ramucirumab or Atezolizumab in Patients With HER2-negative Gastric Adenocarcinoma Expressing FGFR2 Genetic Aberrations",TERMINATED,,PHASE1/PHASE2,47.0,ACTUAL,Basilea Pharmaceutica,,5.0,,Terminated prematurely for administrative reasons not related to patient safety.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,INDUSTRY,,,,,,,2022,0.0
NCT04691232,,2020-12-07,,,2023-10-16,2020-12-28,2020-12-31,ACTUAL,,,,,,,2023-10-16,2023-10-17,ACTUAL,2021-02-22,ACTUAL,2021-02-22,2022-01,2022-01-31,2023-05-22,ACTUAL,2023-05-22,2023-04-12,ACTUAL,2023-04-12,,INTERVENTIONAL,,,Autologous Ex Vivo Expanded Regulatory T Cells in Ulcerative Colitis,"Phase I, Open-label, Fast-track Dose-escalation Clinical Trial Exploring the Safety and the Tolerability of Autologous ex Vivo Expanded Regulatory T Cells in Adults With Ulcerative Colitis",COMPLETED,,PHASE1,11.0,ACTUAL,University of Erlangen-Nürnberg Medical School,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,OTHER,,,,,,,2023,1.0
NCT04444830,,2020-06-07,,,2022-07-27,2020-06-22,2020-06-24,ACTUAL,,,,,,,2022-07-27,2022-07-29,ACTUAL,2021-01,ESTIMATED,2021-01-31,2022-03,2022-03-31,2021-09-21,ACTUAL,2021-09-21,2021-09-21,ACTUAL,2021-09-21,,INTERVENTIONAL,,,Sprix for Postoperative Pain Control Following Gynecologic Surgery,Can Intranasal Ketorolac Tromethamine Prescribed Postoperatively After Major Female Pelvic Reconstructive Surgery Reduce Consumption of Prescribed Narcotics?,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Louisville,,2.0,,Study never opened to enrollment. Study never IRB approved.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,OTHER,,,,,,,2021,0.0
NCT04167462,,2019-11-15,2022-10-06,2022-03-07,2023-02-08,2019-11-15,2019-11-18,ACTUAL,2022-10-06,2022-11-02,ACTUAL,2022-03-07,2022-03-08,ACTUAL,2023-02-08,2023-03-08,ACTUAL,2019-11-25,ACTUAL,2019-11-25,2023-02,2023-02-28,2022-01-07,ACTUAL,2022-01-07,2021-03-08,ACTUAL,2021-03-08,,INTERVENTIONAL,POETYK-PSO-3,,"An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South Korea","A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis",COMPLETED,,PHASE3,220.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,INDUSTRY,,,,,,,2022,1.0
NCT03012581,,2017-01-02,,,2024-02-26,2017-01-04,2017-01-06,ESTIMATED,,,,,,,2024-02-26,2024-02-28,ACTUAL,2017-06-16,ACTUAL,2017-06-16,2024-02,2024-02-29,2023-11-11,ACTUAL,2023-11-11,2022-12-22,ACTUAL,2022-12-22,,INTERVENTIONAL,AcSé,,Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types,Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types,COMPLETED,,PHASE2,269.0,ACTUAL,UNICANCER,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,OTHER,,,,,,,2023,1.0
NCT02032784,,2014-01-08,,,2020-07-15,2014-01-08,2014-01-10,ESTIMATED,,,,,,,2020-07-15,2020-07-16,ACTUAL,2014-03,,2014-03-31,2020-07,2020-07-31,2020-07-06,ACTUAL,2020-07-06,2018-06-28,ACTUAL,2018-06-28,,INTERVENTIONAL,,,Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding,Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding,TERMINATED,,PHASE4,33.0,ACTUAL,AdventHealth,,2.0,,Difficult to enroll subjects,f,,,,t,,,,,,,,,,,NO,,2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,OTHER,,,,,,,2020,0.0
NCT05064800,,2021-09-01,2022-10-18,,2023-10-02,2021-09-22,2021-10-01,ACTUAL,2023-10-02,2024-03-29,ACTUAL,,,,2023-10-02,2024-03-29,ACTUAL,2021-09-21,ACTUAL,2021-09-21,2023-10,2023-10-31,2021-12-06,ACTUAL,2021-12-06,2021-12-06,ACTUAL,2021-12-06,,INTERVENTIONAL,,All participants who were enrolled in the study.,PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants,"A PHASE 1, OPEN-LABEL, 3-TREATMENT, 6-SEQUENCE, 3-PERIOD CROSSOVER STUDY TO ESTIMATE THE EFFECT OF PF-07321332/RITONAVIR AND RITONAVIR ON THE PHARMACOKINETICS OF DABIGATRAN IN HEALTHY PARTICIPANTS",COMPLETED,,PHASE1,24.0,ACTUAL,Pfizer,,3.0,,,,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,INDUSTRY,,,,,,,2021,1.0
NCT02047318,,2014-01-23,2021-03-29,,2021-11-17,2014-01-24,2014-01-28,ESTIMATED,2021-11-17,2021-11-19,ACTUAL,,,,2021-11-17,2021-11-19,ACTUAL,2013-12-20,ACTUAL,2013-12-20,2021-11,2021-11-30,2020-06-17,ACTUAL,2020-06-17,2020-06-17,ACTUAL,2020-06-17,,INTERVENTIONAL,IMAGINE,"After a short dose escalation period, participants received MRX 280 ug/kg/day, which consisted of most of their exposure within the study. As such, summaries are presented as a single arm, MRX.",An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS),"A Multicentre Extension Study to Evaluate the Long-Term Safety and Durability of the Therapeutic Effect of LUM001 Also Known as Maralixibat (MRX), an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome",COMPLETED,,PHASE2,19.0,ACTUAL,"Mirum Pharmaceuticals, Inc.",Limitations of the trial such as small numbers of subjects analyzed or technical problems leading to unreliable data.,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,INDUSTRY,,,,,,,2020,1.0
NCT05347147,,2022-04-20,2024-02-01,,2024-03-26,2022-04-20,2022-04-26,ACTUAL,2024-03-26,2024-04-24,ACTUAL,,,,2024-03-26,2024-04-24,ACTUAL,2022-11-18,ACTUAL,2022-11-18,2024-03,2024-03-31,2023-10-20,ACTUAL,2023-10-20,2023-09-18,ACTUAL,2023-09-18,,INTERVENTIONAL,IIH EVOLVE,,A Trial to Determine the Efficacy and Safety of Presendin in IIH,"A Phase III Randomised, Placebo-controlled, Double-blind, Multi-centre, Clinical Trial to Determine the Efficacy and Safety of Presendin in Idiopathic Intracranial Hypertension",TERMINATED,,PHASE3,14.0,ACTUAL,Invex Therapeutics Ltd.,"Due to the early termination of the study, planned analyses were not fully conducted but were restricted to the most relevant safety endpoints as per the abbreviated SAP v1. Outcome measure (efficacy) data are raw data from individual subjects, with minimal analysis; e.g., where an outcome measure specified change from baseline to Week 24, baseline and Week 24 values are presented. Efficacy data were not subject to the same verification as safety data and no efficacy conclusions should be drawn.",2.0,,"Following a strategic evaluation of its IIH EVOLVE Phase III clinical trial investigating Presendin™, the Invex Board has made the difficult decision that the continuation of the trial is not viable and therefore the trial has been terminated.",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,INDUSTRY,,,,,,,2023,0.0
NCT04839575,,2021-04-07,,,2024-08-01,2021-04-07,2021-04-09,ACTUAL,,,,,,,2024-08-01,2024-08-05,ACTUAL,2021-04-06,ACTUAL,2021-04-06,2023-07,2023-07-31,2022-12-19,ACTUAL,2022-12-19,2022-12-19,ACTUAL,2022-12-19,,INTERVENTIONAL,,,Study of Latiglutenase in T1D/CD Patients,"Prospective, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Type 1 Diabetes Patients With Celiac Disease While Undergoing Periodic Gluten Exposure",TERMINATED,,PHASE2,13.0,ACTUAL,Entero Therapeutics,,2.0,,Covid-19 interruptions and enrollment challenges,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,INDUSTRY,,,,,,,2022,0.0
NCT04575597,,2020-09-30,2023-04-26,,2023-06-05,2020-10-02,2020-10-05,ACTUAL,2023-06-05,2023-06-28,ACTUAL,,,,2023-06-05,2023-06-28,ACTUAL,2020-10-19,ACTUAL,2020-10-19,2023-05,2023-05-31,2022-05-05,ACTUAL,2022-05-05,2022-05-05,ACTUAL,2022-05-05,,INTERVENTIONAL,,,Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002),"A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults With COVID-19.",COMPLETED,,PHASE2/PHASE3,1735.0,ACTUAL,Merck Sharp & Dohme LLC,,6.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,INDUSTRY,,,,,,,2022,1.0
NCT04518995,,2020-08-16,2023-04-07,,2023-04-07,2020-08-16,2020-08-19,ACTUAL,2023-04-07,2023-05-03,ACTUAL,,,,2023-04-07,2023-05-03,ACTUAL,2020-11-23,ACTUAL,2020-11-23,2023-04,2023-04-30,2022-04-19,ACTUAL,2022-04-19,2022-04-19,ACTUAL,2022-04-19,,INTERVENTIONAL,THRIVE-AA1,All randomized participants included all participants who were randomized in the study.,Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1),"A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata (THRIVE-AA1)",COMPLETED,,PHASE3,706.0,ACTUAL,Concert Pharmaceuticals,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,INDUSTRY,,,,,,,2022,1.0
NCT04136444,,2019-10-21,2021-05-28,,2021-07-08,2019-10-21,2019-10-23,ACTUAL,2021-07-08,2021-07-28,ACTUAL,,,,2021-07-08,2021-07-28,ACTUAL,2019-10-28,ACTUAL,2019-10-28,2021-07,2021-07-31,2020-05-22,ACTUAL,2020-05-22,2020-05-22,ACTUAL,2020-05-22,,INTERVENTIONAL,,Baseline Characteristics refer to the Safety Set (SS) which consisted of all study participants who received at least 1 dose of the investigational medicinal product (IMP).,A Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal or Moderately Impaired Hepatic Function,"An Open-Label, Parallel-Group, Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal Hepatic Function or With Moderately Impaired Hepatic Function (Child-Pugh Class B)",TERMINATED,,PHASE1,12.0,ACTUAL,UCB Pharma,,2.0,,"Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures",f,,,,f,t,f,,,f,,,,,,NO,"Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.",2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,INDUSTRY,,,,,,,2020,0.0
NCT04976257,,2021-07-14,,,2023-04-05,2021-07-14,2021-07-26,ACTUAL,,,,,,,2023-04-05,2023-04-07,ACTUAL,2021-10-13,ACTUAL,2021-10-13,2023-04,2023-04-30,2023-03-22,ACTUAL,2023-03-22,2023-03-22,ACTUAL,2023-03-22,,INTERVENTIONAL,,,Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion,Pharmacokinetic Comparison of Selective Prostatic Arterial and Intravenous PSMA Radioligand Infusions in Treatment-Naïve Prostate Cancer Patients,COMPLETED,,EARLY_PHASE1,5.0,ACTUAL,"University of California, San Francisco",,1.0,,,,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,OTHER,,,,,,,2023,1.0
NCT04625972,,2020-11-10,2022-04-06,,2023-11-17,2020-11-10,2020-11-12,ACTUAL,2022-10-24,2022-10-25,ACTUAL,,,,2023-11-17,2023-11-21,ACTUAL,2020-12-02,ACTUAL,2020-12-02,2023-11,2023-11-30,2022-07-25,ACTUAL,2022-07-25,2021-04-07,ACTUAL,2021-04-07,,INTERVENTIONAL,STORM CHASER,Full Analysis Set,"Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults","A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Post-exposure Prophylaxis of COVID-19",COMPLETED,,PHASE3,1131.0,ACTUAL,AstraZeneca,Results are reported for the Primary analysis conducted during the study.,2.0,,,f,,,,t,t,f,,,t,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-17 03:02:07.507684,2024-10-17 03:02:07.507684,INDUSTRY,,,,,,,2022,1.0
NCT04705844,,2021-01-10,,,2022-03-02,2021-01-10,2021-01-12,ACTUAL,,,,,,,2022-03-02,2022-03-03,ACTUAL,2021-09,ESTIMATED,2021-09-30,2022-03,2022-03-31,2022-09,ESTIMATED,2022-09-30,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,COMBAAT,,Study of Adalimumab or Placebo in Patients With Mild to Moderate COVID-19 (COMBAAT),"Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Adalimumab (Humira) or Placebo in Patients With Mild-Moderate COVID-19",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Resilience Government Services, Inc.",,2.0,,study withdrawn prior to screening subjects,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,INDUSTRY,,,,,,,2022,0.0
NCT03355482,,2017-11-22,,,2024-02-16,2017-11-22,2017-11-28,ACTUAL,,,,,,,2024-02-16,2024-02-20,ACTUAL,2017-04-10,ACTUAL,2017-04-10,2024-02,2024-02-29,2022-12-16,ACTUAL,2022-12-16,2022-02-16,ACTUAL,2022-02-16,,INTERVENTIONAL,MEASURE,,MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE,MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE,TERMINATED,,PHASE2,9.0,ACTUAL,Oklahoma Medical Research Foundation,,2.0,,"poor recruitment, funding",,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,OTHER,,,,,,,2022,0.0
NCT03591770,,2018-07-09,,,2024-07-04,2018-07-09,2018-07-19,ACTUAL,,,,,,,2024-07-04,2024-07-08,ACTUAL,2019-07-31,ACTUAL,2019-07-31,2024-07,2024-07-31,2024-07-04,ACTUAL,2024-07-04,2024-07-04,ACTUAL,2024-07-04,,INTERVENTIONAL,,,Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib,The Immunogenicity and Safety of Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib,TERMINATED,,PHASE4,15.0,ACTUAL,Boston Medical Center,,4.0,,Unable to recruit adequate numbers of participants to answer the research question.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,OTHER,,,,,,,2024,0.0
NCT03859973,,2019-02-25,2023-10-30,2023-04-24,2023-10-30,2019-02-28,2019-03-01,ACTUAL,2023-10-30,2023-11-18,ACTUAL,,2023-04-25,ACTUAL,2023-10-30,2023-11-18,ACTUAL,2019-04-15,ACTUAL,2019-04-15,2023-10,2023-10-31,2022-11-04,ACTUAL,2022-11-04,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,,Treated Set (TS) includes all patients in randomized set (RS) who were treated with at least 1 dose of the trial regimen (including both trial drug and computerized cognitive training (CCT)).,This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia,"A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily With Adjunctive Computerized Cognitive Training Over 12 Week Treatment Period in Patients With Schizophrenia",COMPLETED,,PHASE2,200.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,f,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,INDUSTRY,,,,,,,2022,1.0
NCT04301310,,2020-03-06,,,2022-03-17,2020-03-06,2020-03-10,ACTUAL,,,,,,,2022-03-17,2022-03-31,ACTUAL,2020-03-09,ACTUAL,2020-03-09,2022-03,2022-03-31,2020-03-16,ACTUAL,2020-03-16,2020-03-16,ACTUAL,2020-03-16,,INTERVENTIONAL,,,Study to Evaluate the Effect of Rifampin on the Drug Levels in Blood and Safety of BMS-986235 in Healthy Participants,"A Phase 1, Open-label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety, and Tolerability of BMS-986235 in Healthy Participants",WITHDRAWN,,PHASE1,0.0,ACTUAL,Bristol-Myers Squibb,,1.0,,Business objectives have changed,f,,,,f,t,f,,,,,,,,,,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,INDUSTRY,,,,,,,2020,0.0
NCT04395950,,2020-05-15,,,2021-08-19,2020-05-19,2020-05-20,ACTUAL,,,,,,,2021-08-19,2021-08-25,ACTUAL,2020-12,ESTIMATED,2020-12-31,2021-08,2021-08-31,2021-08-19,ACTUAL,2021-08-19,2021-08-19,ACTUAL,2021-08-19,,INTERVENTIONAL,,,Effects of ACC Inhibitor on Lipid and Lipoprotein Metabolism,"A Phase 1B, Single-Blinded, Linear Two Period, Placebo-controlled Study to Evaluate the Effects of 10 mg/Day of PF-05221304, Liver Targeted Acetyl-CoA Carboxylase Inhibitor (ACCi) on Very Low Density Lipoprotein ApoB100 and TG Secretion",WITHDRAWN,,PHASE1,0.0,ACTUAL,Columbia University,,2.0,,Poor enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,OTHER,,,,,,,2021,0.0
NCT03259308,,2017-08-21,2021-03-26,,2021-03-26,2017-08-21,2017-08-23,ACTUAL,2021-03-26,2021-04-26,ACTUAL,,,,2021-03-26,2021-04-26,ACTUAL,2017-12-05,ACTUAL,2017-12-05,2021-03,2021-03-31,2020-10-06,ACTUAL,2020-10-06,2020-07-15,ACTUAL,2020-07-15,,INTERVENTIONAL,FIGARO UC 302,Safety set consisted of all participants who had received at least 1 dose of investigational product.,Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis,"A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 302)",TERMINATED,,PHASE3,279.0,ACTUAL,Takeda,The study was terminated as per the sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.,3.0,,Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.,f,,,,t,t,f,,,,,,,,,,,2024-10-17 03:08:40.171445,2024-10-17 03:08:40.171445,INDUSTRY,,,,,,,2020,0.0
NCT04987944,,2021-07-26,2024-02-02,,2024-02-02,2021-07-26,2021-08-03,ACTUAL,2024-02-02,2024-07-19,ACTUAL,,,,2024-02-02,2024-07-19,ACTUAL,2021-10-18,ACTUAL,2021-10-18,2024-02,2024-02-29,2023-04-04,ACTUAL,2023-04-04,2023-03-29,ACTUAL,2023-03-29,,INTERVENTIONAL,,Safety analysis set included all randomized participants who received at least 1 dose of study therapy.,Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma,"A Phase 1b, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Safety and Efficacy of Oral Zavegepant in Subjects With Mild Allergic Asthma",TERMINATED,,PHASE1,45.0,ACTUAL,Pfizer,,2.0,,Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.,f,,,,,f,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 06:57:07.762525,2024-10-15 06:57:07.762525,INDUSTRY,,,,,,,2023,0.0
NCT05161936,,2021-12-08,2024-02-11,,2024-05-20,2021-12-08,2021-12-17,ACTUAL,2024-05-20,2024-05-22,ACTUAL,,,,2024-05-20,2024-05-22,ACTUAL,2022-01-27,ACTUAL,2022-01-27,2024-04,2024-04-30,2022-11-01,ACTUAL,2022-11-01,2022-11-01,ACTUAL,2022-11-01,,INTERVENTIONAL,,No participants were enrolled or treated with Lumasiran Dose 2.,A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels,"A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Lumasiran in Patients With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels",TERMINATED,,PHASE2,2.0,ACTUAL,Alnylam Pharmaceuticals,,3.0,,Study terminated early due to low enrollment,f,,,,,t,f,,,,,,,,,NO,,2024-10-17 03:08:40.171445,2024-10-17 03:08:40.171445,INDUSTRY,,,,,,,2022,0.0
NCT04082676,,2019-09-01,,,2022-03-08,2019-09-06,2019-09-09,ACTUAL,,,,,,,2022-03-08,2022-03-22,ACTUAL,2019-11-30,ACTUAL,2019-11-30,2022-03,2022-03-31,2021-09-01,ACTUAL,2021-09-01,2021-09-01,ACTUAL,2021-09-01,,INTERVENTIONAL,,,Height Versus Height and Weight Based Spinal Bupivacaine on Maternal Haemodynamics for Elective Cesarean in Short Stature Patients,Effect of Height Versus Height and Weight Based Intrathecal Bupivacaine Dose on Maternal Haemodynamics for Elective Caesarean Section in Short Stature Patients: A Randomized Trial,COMPLETED,,PHASE4,112.0,ACTUAL,B.P. Koirala Institute of Health Sciences,,2.0,,,f,,,,f,f,f,,,,,,The final research data and study protocol will be shared with the journal accepting the article for publication. It will be available simultaneously after publication of the article.,The IPD link will be accessed from the link provided in the published manuscript. The IPD may also be available to other researchers by the investigators upon request.,https://data.mendeley.com/,YES,The final research data will be stored in Mendeley. The final data will be released and shared during the publication process of the manuscript.,2024-10-17 03:08:40.171445,2024-10-17 03:08:40.171445,OTHER,,,,,,,2021,1.0
NCT02974426,,2016-11-20,,,2024-06-10,2016-11-22,2016-11-28,ESTIMATED,,,,,,,2024-06-10,2024-06-12,ACTUAL,2016-11,,2016-11-30,2024-06,2024-06-30,2024-02,ACTUAL,2024-02-29,2024-02,ACTUAL,2024-02-29,,INTERVENTIONAL,,,To Evaluate the Optimal Timing of Postoperative Radiotherapy in Patients With IIIA(N2) Non-Small Cell Lung Cancer,Phase III Study to Evaluate the Optimal Timing of Postoperative Radiotherapy for High Risk of Locoregional Recurrence Patients With Completely Resected Stage IIIA(N2) Non-Small Cell Lung Cancer,TERMINATED,,PHASE3,132.0,ACTUAL,Shanghai Chest Hospital,,2.0,,"Enrollment was delayed and the number of eligible patients significantly declined with the use of neoadjuvant or adjuvant ICIs and TKIs therapies. Thus, this trial was closed due to insufficient accrual.",f,,,,t,,,,,,,,,,,NO,,2024-10-17 03:08:40.171445,2024-10-17 03:08:40.171445,OTHER,,,,,,,2024,0.0
NCT02923921,,2016-09-30,2020-08-14,,2020-09-24,2016-10-03,2016-10-05,ESTIMATED,2020-09-24,2020-10-19,ACTUAL,,,,2020-09-24,2020-10-19,ACTUAL,2017-03-01,ACTUAL,2017-03-01,2020-04-15,2020-04-15,2020-03-05,ACTUAL,2020-03-05,2019-09-09,ACTUAL,2019-09-09,,INTERVENTIONAL,Sequoia,All randomized participants.,Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer,Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Metastatic Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen,COMPLETED,,PHASE3,567.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://www.clinicalstudydatarequest.com,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,INDUSTRY,,,,,,,2020,1.0
NCT03342859,,2017-10-26,,,2021-01-05,2017-11-10,2017-11-17,ACTUAL,,,,,,,2021-01-05,2021-01-06,ACTUAL,2017-11-16,ACTUAL,2017-11-16,2021-01,2021-01-31,2020-01-13,ACTUAL,2020-01-13,2018-12-17,ACTUAL,2018-12-17,,INTERVENTIONAL,,,Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned,"An Open-label, Parallel Group, Multi-center Study to Investigate Pharmacodynamic Effects After Daily Administration of Vilaprisan or Ulipristal Acetate for 8-12 Weeks in Patients With Uterine Fibroids for Whom Surgery (Hysterectomy or Myomectomy) is Planned",TERMINATED,,PHASE1,10.0,ACTUAL,Bayer,,3.0,,Due to findings in the preclinical carcinogenicity studies for vilaprisan (BAY1002670),f,,,,f,f,f,,,,,,,,,,,2024-10-17 03:08:40.171445,2024-10-17 03:08:40.171445,INDUSTRY,,,,,,,2020,0.0
NCT03934307,,2019-04-29,,,2023-01-13,2019-04-29,2019-05-01,ACTUAL,,,,,,,2023-01-13,2023-01-17,ACTUAL,2019-05-01,ACTUAL,2019-05-01,2023-01,2023-01-31,2023-01-04,ACTUAL,2023-01-04,2022-04-20,ACTUAL,2022-04-20,,INTERVENTIONAL,,,A Study to Evaluate ALN-AGT01 in Patients With Hypertension,"A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Dose and Active Comparator-Controlled Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN-AGT01 in Patients With Hypertension",COMPLETED,,PHASE1,124.0,ACTUAL,Alnylam Pharmaceuticals,,7.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-17 03:08:40.171445,2024-10-17 03:08:40.171445,INDUSTRY,,,,,,,2023,1.0
NCT03336866,,2017-11-06,2021-10-20,,2022-02-11,2017-11-06,2017-11-08,ACTUAL,2022-02-11,2022-03-10,ACTUAL,,,,2022-02-11,2022-03-10,ACTUAL,2018-05-03,ACTUAL,2018-05-03,2022-01,2022-01-31,2021-03-09,ACTUAL,2021-03-09,2020-11-23,ACTUAL,2020-11-23,,INTERVENTIONAL,STAMPOUT,,Study of Antibody for Methamphetamine Outpatient Therapy,STAMPOUT: Study of Antibody for Methamphetamine Outpatient Therapy,COMPLETED,,PHASE1/PHASE2,77.0,ACTUAL,"InterveXion Therapeutics, LLC","All participants were dosed with methamphetamine on a weekly basis following treatment with IXT-m200 or placebo. Thus, safety of IXT-m200 alone cannot be distinguished from the expected adverse events resulting from the methamphetamine doses. Variability of the responses on the drug effects questionnaires was much higher than anticipated. This resulted in insufficient power to detect differences between treated and control groups.",2.0,,,f,,,,t,t,f,,,,,,These datasets will be available for distribution following submission to the FDA of the Clinical Study Report and publication. They will be available for 2 years after the initial publication.,These datasets and associated documentation will be made available on CD by the Sponsor to requestors under a data sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology and not distributing to third parties; and (3) a commitment to destroying or returning the data after analyses are completed. Requests should be sent to intervexion@gmail.com.,,YES,"Final datasets are expected to contain pharmacokinetic data on IXT-m200 and METH, subjective effects data, immunogenicity totals, and safety data. No individually identifiable private information will be distributed.",2024-10-17 03:08:40.171445,2024-10-17 03:08:40.171445,INDUSTRY,,,,,,,2021,1.0
NCT04374552,,2020-05-02,,,2020-10-29,2020-05-02,2020-05-05,ACTUAL,,,,,,,2020-10-29,2020-11-02,ACTUAL,2020-05-05,ESTIMATED,2020-05-05,2020-05,2020-05-31,2021-04,ESTIMATED,2021-04-30,2020-11,ESTIMATED,2020-11-30,,INTERVENTIONAL,ACT,,Asymptomatic COVID-19 Trial,RCT in Asymptomatic Volunteers With COVID-19 Comparing Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone vs Standard of Care Without Antibiotics,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Rutgers, The State University of New Jersey",,2.0,,The investigators have decided not to go forward with this protocol,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-17 03:08:40.171445,2024-10-17 03:08:40.171445,OTHER,,,,,,,2021,0.0
NCT01734928,,2012-11-23,2023-05-09,,2023-06-05,2012-11-27,2012-11-28,ESTIMATED,2023-06-05,2023-06-06,ACTUAL,,,,2023-06-05,2023-06-06,ACTUAL,2013-01-07,ACTUAL,2013-01-07,2023-05,2023-05-31,2022-05-13,ACTUAL,2022-05-13,2022-05-09,ACTUAL,2022-05-09,,INTERVENTIONAL,OPTIMISMM,,"Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma","A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma",COMPLETED,,PHASE3,559.0,ACTUAL,Celgene,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-17 03:08:40.171445,2024-10-17 03:08:40.171445,INDUSTRY,,,,,,,2022,1.0
NCT02427178,,2015-02-10,,,2022-07-28,2015-04-22,2015-04-27,ESTIMATED,,,,,,,2022-07-28,2022-08-01,ACTUAL,2015-03,ESTIMATED,2015-03-31,2022-07,2022-07-31,2023-06,ESTIMATED,2023-06-30,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,MASS,,MNGIE Allogeneic Hematopoietic Stem Cell Transplant Safety Study,MNGIE (Mitochondrial Neurogastrointestinal Encephalomyopathy) AHSCT (Allogeneic Hematopoietic Stem Cell Transplant) Safety Study,WITHDRAWN,,PHASE1,0.0,ACTUAL,Columbia University,,1.0,,Poor enrollment,f,,,,t,,,,,,,,,,,YES,"When applicable, we will submit a manuscript describing the results",2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,OTHER,,,,,,,2023,0.0
NCT04131192,,2019-10-10,,,2022-05-04,2019-10-16,2019-10-18,ACTUAL,,,,,,,2022-05-04,2022-05-06,ACTUAL,2019-11-11,ACTUAL,2019-11-11,2022-05,2022-05-31,2021-09-09,ACTUAL,2021-09-09,2021-09-09,ACTUAL,2021-09-09,,INTERVENTIONAL,,,Gemcitabine and Z650 in Treating Patients With Metastatic or Recurrent Pancreatic Cancer,"A Phase Ib, Multi-center, Open-label Study of Z650 and Gemcitabine in Advanced Pancreatic Cancer",TERMINATED,,PHASE1,13.0,ACTUAL,"Sunshine Lake Pharma Co., Ltd.",,1.0,,"Combined with the analysis of the existing data of the trial, there was no obvious advantage compared with the clinical standard treatments, and the clinical trial was decided to be terminated based on the benefit of the subjects.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 03:08:40.171445,2024-10-17 03:08:40.171445,INDUSTRY,,,,,,,2021,0.0
NCT04133922,,2019-10-15,,,2022-03-07,2019-10-17,2019-10-21,ACTUAL,,,,,,,2022-03-07,2022-03-22,ACTUAL,2019-10-14,ACTUAL,2019-10-14,2022-03,2022-03-31,2024-10,ESTIMATED,2024-10-31,2023-10,ESTIMATED,2023-10-31,,INTERVENTIONAL,KML001,,Effect of GLP-1 on Microvascular Insulin Responses in Type 1 Diabetes,Effect of GLP-1 on Microvascular Insulin Responses in Type 1 Diabetes,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Virginia,,3.0,,the study drug could not be obtained,f,,,,f,t,f,,,,,,,,,,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,OTHER,,,,,,,2024,0.0
NCT05665647,,2022-12-19,,,2023-02-19,2022-12-19,2022-12-27,ACTUAL,,,,,,,2023-02-19,2023-02-21,ACTUAL,2022-12-29,ACTUAL,2022-12-29,2023-01,2023-01-31,2023-02-14,ACTUAL,2023-02-14,2023-01-26,ACTUAL,2023-01-26,,INTERVENTIONAL,,,"Drug-Drug Interaction Study of Itraconazole, Rifampicin and Midazolam With SIM0417/Ritonavir in Healthy Participants","An Open Labe Study to Evaluate the Drug-Drug Interaction of Itraconazole, Rifampicin and Midazolam With SIM0417/Ritonavir in Healthy Adult Chinese Participants",COMPLETED,,PHASE1,36.0,ACTUAL,"Jiangsu Simcere Pharmaceutical Co., Ltd.",,3.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 03:08:40.171445,2024-10-17 03:08:40.171445,INDUSTRY,,,,,,,2023,1.0
NCT02965976,,2016-11-15,2023-01-23,,2023-01-23,2016-11-15,2016-11-17,ESTIMATED,2023-01-23,2023-02-16,ACTUAL,,,,2023-01-23,2023-02-16,ACTUAL,2016-12-30,ACTUAL,2016-12-30,2023-01,2023-01-31,2022-04-28,ACTUAL,2022-04-28,2022-01-28,ACTUAL,2022-01-28,,INTERVENTIONAL,,,Botulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer,"Double-Arm, Randomized Study of Botulinum Toxin Injection as a Pyloric Drainage Procedure for Minimally Invasive Esophagectomy (Phase II)",COMPLETED,,PHASE2,33.0,ACTUAL,Roswell Park Cancer Institute,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-17 03:08:40.171445,2024-10-17 03:08:40.171445,OTHER,,,,,,,2022,1.0
NCT04521946,,2020-08-18,,,2023-10-02,2020-08-18,2020-08-21,ACTUAL,,,,,,,2023-10-02,2023-10-04,ACTUAL,2021-01-14,ACTUAL,2021-01-14,2023-10,2023-10-31,2022-12-20,ACTUAL,2022-12-20,2022-12-20,ACTUAL,2022-12-20,,INTERVENTIONAL,,,Chemotherapy and Donor Stem Transplant for the Treatment of Patients With High Grade Brain Cancer,A Pilot Study of Allogeneic Hematopoietic Cell Transplantation for Patients With High Grade Central Nervous System Malignancies,WITHDRAWN,,PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,No participants enrolled.,,,,,t,t,f,,,,,,,,,,,2024-10-17 03:08:40.171445,2024-10-17 03:08:40.171445,OTHER,,,,,,,2022,0.0
NCT02931110,,2016-06-06,,,2020-12-08,2016-10-11,2016-10-12,ESTIMATED,,,,,,,2020-12-08,2020-12-10,ACTUAL,2017-01,ACTUAL,2017-01-31,2020-12,2020-12-31,2020-10,ACTUAL,2020-10-31,2020-10,ACTUAL,2020-10-31,,INTERVENTIONAL,,,Study of IV CBL0137 in Previously Treated Hematological Subjects,A Phase 1 Dose-Escalation and Cohort-Expansion Study of Intravenous CBL0137 in Subjects With Previously Treated Hematological Cancers,TERMINATED,,PHASE1,5.0,ACTUAL,Incuron,,1.0,,Business reasons,f,,,,f,,,,,,,,,,,NO,,2024-10-17 03:08:40.171445,2024-10-17 03:08:40.171445,INDUSTRY,,,,,,,2020,0.0
NCT04338997,,2020-04-03,,,2020-12-02,2020-04-07,2020-04-08,ACTUAL,,,,,,,2020-12-02,2020-12-04,ACTUAL,2020-10,ESTIMATED,2020-10-31,2020-09,2020-09-30,2020-12,ESTIMATED,2020-12-31,2020-11,ESTIMATED,2020-11-30,,INTERVENTIONAL,,,PK Study in Patients With Parkinson's Disease With IZD174,"An Open-label Phase 1b Study to Evaluate the Pharmacokinetics and Pharmacodynamics in Plasma and Cerebrospinal Fluid (CSF), Safety and Tolerability of Oral IZD174 in Patients With Parkinson's Disease",WITHDRAWN,,PHASE1,0.0,ACTUAL,Inflazome UK Ltd,,1.0,,Strategic decision by Sponsor,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 03:08:40.171445,2024-10-17 03:08:40.171445,INDUSTRY,,,,,,,2020,0.0
NCT03191201,,2017-05-17,,,2020-03-24,2017-06-15,2017-06-19,ACTUAL,,,,,,,2020-03-24,2020-03-26,ACTUAL,2017-06-21,ACTUAL,2017-06-21,2020-03,2020-03-31,2020-03-09,ACTUAL,2020-03-09,2020-03-09,ACTUAL,2020-03-09,,INTERVENTIONAL,DIAFER,,A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucose Homeostasis.,"A Double Blind Randomised Placebo-controlled Trial to Assess the Effect of a Single Administration of Ferric Carboxymaltose of 1000 mg Iron on Glucose Homeostasis, in Iron-deficient Non-anaemic Women of Childbearing Age.",TERMINATED,,PHASE4,32.0,ACTUAL,University of Lausanne,,2.0,,The reason for early termination is difficulties recruiting that caused a premature ending of financial resources ensuring protected time for research.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-17 03:08:40.171445,2024-10-17 03:08:40.171445,OTHER,,,,,,,2020,0.0
NCT04210245,,2019-12-16,,,2023-06-09,2019-12-20,2019-12-24,ACTUAL,,,,,,,2023-06-09,2023-06-13,ACTUAL,2020-03-23,ACTUAL,2020-03-23,2023-06,2023-06-30,2023-02-23,ACTUAL,2023-02-23,2023-01-04,ACTUAL,2023-01-04,,INTERVENTIONAL,,,Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4),"Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)",COMPLETED,,PHASE2,160.0,ACTUAL,"NGM Biopharmaceuticals, Inc",,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,INDUSTRY,,,,,,,2023,1.0
NCT01208051,,2010-09-22,2021-03-22,,2021-06-24,2010-09-22,2010-09-23,ESTIMATED,2021-06-24,2021-07-15,ACTUAL,,,,2021-06-24,2021-07-15,ACTUAL,2010-09-09,ACTUAL,2010-09-09,2021-06,2021-06-30,2020-02-01,ACTUAL,2020-02-01,2020-02-01,ACTUAL,2020-02-01,,INTERVENTIONAL,,,Cediranib Maleate With or Without Lenalidomide for the Treatment of Thyroid Cancer,Phase I/II Trial of Cediranib Alone or Cediranib and Lenalidomide in Iodine 131-Refractory Differentiated Thyroid Cancer,COMPLETED,,PHASE1/PHASE2,127.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,NIH,,,,,,,2020,1.0
NCT02295722,,2014-10-30,,,2024-07-04,2014-11-18,2014-11-20,ESTIMATED,,,,,,,2024-07-04,2024-07-08,ACTUAL,2015-04,,2015-04-30,2024-07,2024-07-31,2023-02,ACTUAL,2023-02-28,2023-02,ACTUAL,2023-02-28,,INTERVENTIONAL,GEMHDM2014,,GEMHDM2014 : Gem-HDM HDT and ASCT for Relapsed/ Refractory Lymphoma,Infusional Gemcitabine and High-dose Melphalan (HDM) Conditioning Prior to (ASCT) Autologous Stem Cell Transplantation for Patients With Relapsed/Refractory Lymphoma,TERMINATED,,PHASE1/PHASE2,100.0,ACTUAL,AHS Cancer Control Alberta,,1.0,,It did not show a significant benefit to justify completing the full target accrual.,f,,,,f,,,,,,,,,,,NO,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,OTHER,,,,,,,2023,0.0
NCT03331562,,2017-10-18,2021-11-09,,2022-12-01,2017-10-31,2017-11-06,ACTUAL,2022-12-01,2022-12-27,ACTUAL,,,,2022-12-01,2022-12-27,ACTUAL,2017-12-27,ACTUAL,2017-12-27,2022-12,2022-12-31,2020-07-10,ACTUAL,2020-07-10,2020-06-29,ACTUAL,2020-06-29,,INTERVENTIONAL,,,A SU2C Catalyst® Trial of a PD1 Inhibitor With or Without a Vitamin D Analog for the Maintenance of Pancreatic Cancer,A SU2C Catalyst ® Randomized Phase II Trial of the PD1 Inhibitor Pembrolizumab With or Without a Vitamin D Receptor Agonist Paricalcitol in Patients With Stage IV Pancreatic Cancer Who Have Been Placed in Best Possible Response,COMPLETED,,PHASE2,24.0,ACTUAL,Translational Genomics Research Institute,"Due to lack of grant funding, the other exploratory objectives to assess the changes in tumor and/or tissue texture on imaging, and to monitor and compare gut microbial communities in both arms, have not yet been able to be accomplished. The Investigators are looking for some way to fund the exploratory objectives in the future.",2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,OTHER,,,,,,,2020,1.0
NCT04243837,,2020-01-21,2024-01-30,2023-09-07,2024-03-26,2020-01-24,2020-01-28,ACTUAL,2024-03-26,2024-04-23,ACTUAL,,2024-04-23,ACTUAL,2024-03-26,2024-04-23,ACTUAL,2020-03-01,ACTUAL,2020-03-01,2022-04,2022-04-30,2022-09-09,ACTUAL,2022-09-09,2022-09-09,ACTUAL,2022-09-09,,INTERVENTIONAL,,,LYT-100 in Patients With BCRL,"A Phase 2a Double-Blind, Placebo-Controlled Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of Deupirfenidone (LYT-100) in Patients With Breast Cancer-Related Upper Limb Secondary Lymphoedema",TERMINATED,,PHASE2,50.0,ACTUAL,PureTech,,2.0,,"Primary objective/endpoint has been established, will not pursue development of the disease indication further",f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,INDUSTRY,,,,,,,2022,0.0
NCT03134638,,2017-04-19,,,2021-03-05,2017-04-25,2017-05-01,ACTUAL,,,,,,,2021-03-05,2021-03-09,ACTUAL,2017-05-12,ACTUAL,2017-05-12,2019-11,2019-11-30,2020-06-24,ACTUAL,2020-06-24,2020-05-15,ACTUAL,2020-05-15,,INTERVENTIONAL,,,A Study of SY-1365 in Adult Patients With Advanced Solid Tumors,"A Phase 1 Study of SY-1365, a Selective CDK7 Inhibitor, in Adult Patients With Advanced Solid Tumors",TERMINATED,,PHASE1,107.0,ACTUAL,Syros Pharmaceuticals,,6.0,,Business Decision,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,INDUSTRY,,,,,,,2020,0.0
NCT03434366,,2018-01-28,,,2022-04-05,2018-02-09,2018-02-15,ACTUAL,,,,,,,2022-04-05,2022-04-12,ACTUAL,2018-01-20,ACTUAL,2018-01-20,2022-04,2022-04-30,2023-12-30,ESTIMATED,2023-12-30,2023-12-30,ESTIMATED,2023-12-30,,INTERVENTIONAL,,,Intranasal Ketamine With Dexmedetomidine for the Treatment of Children With Autism Spectrum Disorder,Intranasal Ketamine With Dexmedetomidine for the Treatment of Children With Autism Spectrum Disorder,SUSPENDED,,PHASE2,50.0,ESTIMATED,Guangzhou Women and Children's Medical Center,,3.0,,The effects are not good,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,OTHER,,,,,,,2023,0.0
NCT03312907,,2017-10-13,2022-03-25,2020-12-01,2022-03-25,2017-10-13,2017-10-18,ACTUAL,2022-03-25,2022-04-25,ACTUAL,2020-12-01,2020-12-08,ACTUAL,2022-03-25,2022-04-25,ACTUAL,2018-03-01,ACTUAL,2018-03-01,2022-02,2022-02-28,2021-07-07,ACTUAL,2021-07-07,2020-05-29,ACTUAL,2020-05-29,,INTERVENTIONAL,,Baseline characteristics were presented for Intent-to-Treat Population.,A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE,"A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE)",COMPLETED,,PHASE3,292.0,ACTUAL,GlaxoSmithKline,,3.0,,,t,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,INDUSTRY,,NCT03125486,NO_LONGER_AVAILABLE,,,,2021,1.0
NCT04130802,,2019-10-16,2022-02-17,2021-01-13,2023-01-13,2019-10-16,2019-10-17,ACTUAL,2022-02-17,2022-03-15,ACTUAL,2021-01-13,2021-01-15,ACTUAL,2023-01-13,2023-01-17,ACTUAL,2019-09-27,ACTUAL,2019-09-27,2021-01,2021-01-31,2020-01-31,ACTUAL,2020-01-31,2020-01-31,ACTUAL,2020-01-31,,INTERVENTIONAL,SKYGGN,,OCS-01 in Treating Inflammation and Pain in Post-cataract Patients,"A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of Two Doses of OCS 01 Compared to Vehicle in the Treatment of Inflammation and Pain Following Cataract Surgery",COMPLETED,,PHASE2,153.0,ACTUAL,Oculis,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,INDUSTRY,,,,,,,2020,1.0
NCT02541903,,2015-08-24,2020-03-03,,2020-04-10,2015-09-03,2015-09-04,ESTIMATED,2020-04-10,2020-04-14,ACTUAL,,,,2020-04-10,2020-04-14,ACTUAL,2015-10,,2015-10-31,2020-04,2020-04-30,2020-04,ACTUAL,2020-04-30,2019-01-26,ACTUAL,2019-01-26,,INTERVENTIONAL,,1 patient expired after signing consent but before starting treatment,Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma,A Phase 2 Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma Following Systemic Therapy,TERMINATED,,PHASE2,8.0,ACTUAL,University of Alabama at Birmingham,This study was closed early due to poor enrollment.,1.0,,poor overall accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,OTHER,,,,,,,2020,0.0
NCT03083041,,2017-03-02,,,2023-02-02,2017-03-13,2017-03-17,ACTUAL,,,,,,,2023-02-02,2023-02-03,ACTUAL,2017-03-22,ACTUAL,2017-03-22,2022-06,2022-06-30,2022-05-20,ACTUAL,2022-05-20,2022-04-22,ACTUAL,2022-04-22,,INTERVENTIONAL,,,A Study of SHR-1210 in Combination With Apatinib in Advanced Non-Small Cell Lung Cancer(NSCLC),A Phase II Study of SHR-1210 in Combination With Apatinib in Advanced Non-Small Cell Lung,COMPLETED,,PHASE2,210.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,3.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,INDUSTRY,,,,,,,2022,1.0
NCT04381988,,2020-05-08,2021-10-25,,2021-10-25,2020-05-08,2020-05-11,ACTUAL,2021-10-25,2021-10-27,ACTUAL,,,,2021-10-25,2021-10-27,ACTUAL,2020-05-07,ACTUAL,2020-05-07,2021-04,2021-04-30,2021-04-21,ACTUAL,2021-04-21,2021-04-21,ACTUAL,2021-04-21,,INTERVENTIONAL,,The study was terminated before more participants were accrued.,A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy,A Phase II Randomized Double-Blind Placebo-Controlled Clinical Trial Of Hydroxychloroquine For Prophylaxis Against Covid-19 In Patients Receiving Radiotherapy (COVID),TERMINATED,,PHASE2,4.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,2.0,,The study was terminated based results of other studies and use of the new vaccine.,f,,,,,t,f,,,f,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,OTHER,,,,,,,2021,0.0
NCT01750281,,2012-12-12,2017-01-13,,2023-10-12,2012-12-13,2012-12-17,ESTIMATED,2017-06-21,2017-07-19,ACTUAL,,,,2023-10-12,2023-10-24,ACTUAL,2012-12-18,ACTUAL,2012-12-18,2023-10,2023-10-31,2022-10-31,ACTUAL,2022-10-31,2016-01-27,ACTUAL,2016-01-27,,INTERVENTIONAL,SELECT-2,,Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.,"A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, Compared With Placebo in Combination With Docetaxel, in Patients Receiving Second Line Treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)",COMPLETED,,PHASE2,212.0,ACTUAL,AstraZeneca,,3.0,,,f,,,,t,,,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,INDUSTRY,,,,,,,2022,1.0
NCT01873833,,2013-06-06,2022-11-11,,2023-09-12,2013-06-06,2013-06-10,ESTIMATED,2023-09-12,2023-10-05,ACTUAL,,,,2023-09-12,2023-10-05,ACTUAL,2013-07-29,ACTUAL,2013-07-29,2023-09,2023-09-30,2021-03-02,ACTUAL,2021-03-02,2021-03-02,ACTUAL,2021-03-02,,INTERVENTIONAL,,,"Capecitabine, Cyclophosphamide, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With HER2-Positive Metastatic Breast Cancer",Phase II Trial of Metronomic Capecitabine and Cyclophosphamide With Lapatinib and Trastuzumab in Patients With HER2 Positive Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-Based Regimen,TERMINATED,,PHASE2,10.0,ACTUAL,University of Southern California,,1.0,,Insufficient accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,OTHER,,,,,,,2021,0.0
NCT03478787,,2018-03-23,2021-06-21,,2021-06-21,2018-03-23,2018-03-27,ACTUAL,2021-06-21,2021-07-13,ACTUAL,,,,2021-06-21,2021-07-13,ACTUAL,2018-05-08,ACTUAL,2018-05-08,2021-06,2021-06-30,2020-07-08,ACTUAL,2020-07-08,2020-07-08,ACTUAL,2020-07-08,,INTERVENTIONAL,,,Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis,"A Multicenter, Randomized, Open Label, Efficacy Assessor-Blinded Study of Risankizumab Compared to Secukinumab for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy",COMPLETED,,PHASE3,327.0,ACTUAL,AbbVie,,2.0,,,f,,,,f,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,INDUSTRY,,,,,,,2020,1.0
NCT04220281,,2020-01-04,,,2020-02-12,2020-01-06,2020-01-07,ACTUAL,,,,,,,2020-02-12,2020-02-17,ACTUAL,2019-12-01,ACTUAL,2019-12-01,2020-02,2020-02-29,2020-02-12,ACTUAL,2020-02-12,2020-02-12,ACTUAL,2020-02-12,,INTERVENTIONAL,prop,,Comparison Between Two Drugs (Propofol and Nitroglycerin as a Hypotensive Agents During Endoscopic Sinus Surgery,Comparison of the Hypotensive Efficacy of Propofol Infusion Versus Nitroglycerin Infusion in Functional Endoscopic Sinus Surgery,TERMINATED,,PHASE1/PHASE2,40.0,ACTUAL,Ain Shams University,,2.0,,the number of patients needed for the study have been collected,f,,,,f,f,f,,,,,,,,,,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,OTHER,,,,,,,2020,0.0
NCT04251156,,2020-01-30,,,2023-06-26,2020-01-30,2020-01-31,ACTUAL,,,,,,,2023-06-26,2023-06-27,ACTUAL,2020-12-08,ACTUAL,2020-12-08,2023-06,2023-06-30,2022-09-18,ACTUAL,2022-09-18,2022-08-23,ACTUAL,2022-08-23,,INTERVENTIONAL,STEP 7,,Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity,Effect and Safety of Semaglutide 2.4 mg Once-weekly on Weight Management in Subjects With Overweight or Obesity,COMPLETED,,PHASE3,375.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,f,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,INDUSTRY,,,,,,,2022,1.0
NCT02623439,,2013-08-29,,,2022-07-20,2015-12-04,2015-12-07,ESTIMATED,,,,,,,2022-07-20,2022-07-21,ACTUAL,2012-07,,2012-07-31,2022-07,2022-07-31,2022-07,ESTIMATED,2022-07-31,2022-07,ESTIMATED,2022-07-31,,INTERVENTIONAL,,,A Study of Haploidentical Bone Marrow Transplant for Patients With Hematologic Malignancies,A Phase 2 Study of Nonmyeloablative Conditioning With Transplantation of Partially Human Leukocyte Antigen (HLA)-Mismatched Bone Marrow and Post-transplant Cyclophosphamide for Patients With Hematologic Malignancies,SUSPENDED,,PHASE2,20.0,ESTIMATED,"University of California, San Diego",,1.0,,On hold for toxicitiy,f,,,,t,,,,,,,,,,,,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,OTHER,,,,,,,2022,0.0
NCT04063904,,2019-08-13,,,2021-07-19,2019-08-20,2019-08-21,ACTUAL,,,,,,,2021-07-19,2021-07-23,ACTUAL,2019-10-16,ACTUAL,2019-10-16,2021-07,2021-07-31,2021-04-03,ACTUAL,2021-04-03,2020-04-03,ACTUAL,2020-04-03,,INTERVENTIONAL,,,Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia,Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia,TERMINATED,,PHASE4,16.0,ACTUAL,Gynuity Health Projects,,1.0,,"Difficulties with recruitment, COVID 19 pandemic",f,,,,t,f,f,,,f,,,,,,,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,OTHER,,,,,,,2021,0.0
NCT03548415,,2018-05-22,2022-10-21,2022-03-25,2022-10-21,2018-06-05,2018-06-07,ACTUAL,2022-10-21,2022-11-14,ACTUAL,2022-03-25,2022-03-29,ACTUAL,2022-10-21,2022-11-14,ACTUAL,2018-09-13,ACTUAL,2018-09-13,2022-10,2022-10-31,2021-04-02,ACTUAL,2021-04-02,2021-02-18,ACTUAL,2021-02-18,,INTERVENTIONAL,,The Safety Set included all participants who were randomized and received at least one dose of Study Drug.,"Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands","A Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 766720 (IONIS-GHR-LRx, an Antisense Inhibitor of the Growth Hormone Receptor) Administered Once Every 28 Days for 16 Weeks in Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (SRL)",COMPLETED,,PHASE2,43.0,ACTUAL,"Ionis Pharmaceuticals, Inc.","While no longer powered to assess the primary endpoint (% IGF- lowering at Day 141) in accordance with the protocol, the study did permit placebo-controlled evaluation of safety and efficacy.",5.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,INDUSTRY,,,,,,,2021,1.0
NCT03439514,,2018-02-01,2023-12-18,,2023-12-18,2018-02-13,2018-02-20,ACTUAL,2023-12-18,2024-01-09,ACTUAL,,,,2023-12-18,2024-01-09,ACTUAL,2018-04-17,ACTUAL,2018-04-17,2023-12,2023-12-31,2022-10-13,ACTUAL,2022-10-13,2022-10-13,ACTUAL,2022-10-13,,INTERVENTIONAL,REALM-DCM,The full analysis set (FAS) consisted of all randomized participants.,A Study of ARRY-371797 (PF-07265803) in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation,"A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 (PF-07265803) in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation (REALM-DCM)",TERMINATED,,PHASE3,77.0,ACTUAL,Pfizer,,2.0,,The Sponsor terminated the study due to futility. The decision to stop the study was not based on safety concerns.,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,INDUSTRY,,,,,,,2022,0.0
NCT03676725,,2018-09-17,2020-10-30,,2022-09-30,2018-09-17,2018-09-19,ACTUAL,2021-07-07,2021-07-14,ACTUAL,,,,2022-09-30,2022-10-06,ACTUAL,2019-08-14,ACTUAL,2019-08-14,2022-09,2022-09-30,2020-03-01,ACTUAL,2020-03-01,2020-03-01,ACTUAL,2020-03-01,,INTERVENTIONAL,,,Prevalence of Lidocaine Ineffectiveness in Adults With and Without ADHD,"Assessing the Frequency of Lidocaine Ineffectiveness in the General Population vs. Males With ADHD, and Females With ADHD, With or Without PMS",COMPLETED,,EARLY_PHASE1,90.0,ACTUAL,"PhenoSolve, LLC",,1.0,,,f,,,,f,t,f,,,t,,,9-12 months,Researchers,https://phenosolve.com,YES,"We plan to submit for publication descriptions of what was accomplished, and the evaluations as described in the study, including the incidence of lidocaine ineffectiveness in those with ADHD and in the general population.",2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,INDUSTRY,,,,,,,2020,1.0
NCT04359680,,2020-04-20,2024-05-24,,2024-06-18,2020-04-20,2020-04-24,ACTUAL,2024-06-18,2024-06-26,ACTUAL,,,,2024-06-18,2024-06-26,ACTUAL,2020-05-13,ACTUAL,2020-05-13,2024-06,2024-06-30,2021-04-07,ACTUAL,2021-04-07,2021-04-07,ACTUAL,2021-04-07,,INTERVENTIONAL,,Safety population consists of all subjects receiving at least one dose of study medication.,Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection,"A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection",COMPLETED,,PHASE3,1407.0,ACTUAL,Romark Laboratories L.C.,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,INDUSTRY,,,,,,,2021,1.0
NCT03358706,,2017-11-27,,,2024-06-20,2017-11-27,2017-12-02,ACTUAL,,,,,,,2024-06-20,2024-06-21,ACTUAL,2018-02-02,ACTUAL,2018-02-02,2024-06,2024-06-30,2024-10-01,ESTIMATED,2024-10-01,2024-10-01,ESTIMATED,2024-10-01,,INTERVENTIONAL,,,A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis,"A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis.",SUSPENDED,,PHASE1,57.0,ESTIMATED,"Janssen Research & Development, LLC",,2.0,,unavailability of probe substrates,f,,,,f,t,f,,,,,,,,,,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,INDUSTRY,,,,,,,2024,0.0
NCT03338959,,2017-11-07,2024-06-05,,2024-07-19,2017-11-07,2017-11-09,ACTUAL,2024-07-19,2024-07-23,ACTUAL,,,,2024-07-19,2024-07-23,ACTUAL,2018-03-28,ACTUAL,2018-03-28,2024-07,2024-07-31,2023-08-04,ACTUAL,2023-08-04,2023-06-08,ACTUAL,2023-06-08,,INTERVENTIONAL,,,Pembrolizumab and Radiation Therapy in Treating Patients With Intermediate or High-Grade Soft Tissue Sarcoma,"A Pilot Study of Pembrolizumab and Neoadjuvant Radiation for Large, High-Risk Soft Tissue Sarcomas",COMPLETED,,PHASE1/PHASE2,27.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,OTHER,,,,,,,2023,0.0
NCT03847090,,2019-02-18,,,2022-06-09,2019-02-19,2019-02-20,ACTUAL,,,,,,,2022-06-09,2022-06-10,ACTUAL,2019-08-26,ACTUAL,2019-08-26,2022-06,2022-06-30,2022-05-19,ACTUAL,2022-05-19,2022-05-19,ACTUAL,2022-05-19,,INTERVENTIONAL,URIROX-2,,Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria,"Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)",TERMINATED,,PHASE3,92.0,ACTUAL,Allena Pharmaceuticals,,2.0,,Interim Analysis -,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,INDUSTRY,,,,,,,2022,0.0
NCT03197935,,2017-06-21,2021-03-29,,2023-10-23,2017-06-21,2017-06-23,ACTUAL,2021-05-07,2021-06-02,ACTUAL,,,,2023-10-23,2023-10-26,ACTUAL,2017-07-24,ACTUAL,2017-07-24,2023-10,2023-10-31,2022-09-28,ACTUAL,2022-09-28,2020-04-03,ACTUAL,2020-04-03,,INTERVENTIONAL,IMpassion031,,A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer,A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer,COMPLETED,,PHASE3,333.0,ACTUAL,Hoffmann-La Roche,"This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of EFS, DFS and OS. The analyses of these secondary endpoints are descriptive in nature.",2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,INDUSTRY,,,,,,,2022,1.0
NCT03868566,,2019-03-06,,,2023-01-04,2019-03-06,2019-03-11,ACTUAL,,,,,,,2023-01-04,2023-01-06,ACTUAL,2017-08-04,ACTUAL,2017-08-04,2023-01,2023-01-31,2021-10-19,ACTUAL,2021-10-19,2021-09-22,ACTUAL,2021-09-22,,INTERVENTIONAL,,,"An Open-Label Study to Assess the Hepatic Protection Effect of SNP-612, in Patients With NAFLD","An Open-Label Study to Assess the Hepatic Protection Effect of a Food Supplement Product, SNP-612, in Patients With Non-alcoholic Fatty Liver Disease",TERMINATED,,PHASE2,90.0,ACTUAL,Sinew Pharma Inc.,,2.0,,recruitment difficulties due to Covid-19,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,INDUSTRY,,,,,,,2021,0.0
NCT04218565,,2019-12-08,,,2023-04-05,2020-01-02,2020-01-06,ACTUAL,,,,,,,2023-04-05,2023-04-07,ACTUAL,2020-02-15,ACTUAL,2020-02-15,2023-04,2023-04-30,2022-12-15,ACTUAL,2022-12-15,2022-12-15,ACTUAL,2022-12-15,,INTERVENTIONAL,,,Golimumab for the Treatment of Refractory Behcet's Uveitis,Efficacy and Safety of Golimumab in the Treatment of Refractory Uveitis in Patients With Behcet's Disease,TERMINATED,,PHASE2,1.0,ACTUAL,Peking Union Medical College Hospital,,1.0,,only one patient enrolled,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,OTHER,,,,,,,2022,0.0
NCT05053737,,2021-08-17,,,2024-06-21,2021-09-20,2021-09-22,ACTUAL,,,,,,,2024-06-21,2024-06-24,ACTUAL,2021-11-02,ACTUAL,2021-11-02,2024-06,2024-06-30,2024-11,ESTIMATED,2024-11-30,2023-11-24,ACTUAL,2023-11-24,,INTERVENTIONAL,,,Radiotherapy in Combination With Atezolizumab Prior to Surgical Resection for HPV Unrelated HNSCC,Phase I/II Trial of Radiotherapy in Combination With Atezolizumab Prior to Surgical Resection for HPV-unrelated Squamous Cell Carcinoma of the Head and Neck (HNSCC),SUSPENDED,,PHASE1,11.0,ACTUAL,"University of Colorado, Denver",,2.0,,Interim Analysis,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,OTHER,,,,,,,2024,0.0
NCT03978156,,2019-05-22,,,2021-01-21,2019-06-05,2019-06-06,ACTUAL,,,,,,,2021-01-21,2021-01-26,ACTUAL,2019-07-26,ACTUAL,2019-07-26,2021-01,2021-01-31,2021-01-01,ACTUAL,2021-01-01,2021-01-01,ACTUAL,2021-01-01,,INTERVENTIONAL,,,Dronabinol for Pain and Inflammation in Adults Living With Sickle Cell Disease,Dronabinol for Pain and Inflammation in Adults Living With Sickle Cell Disease,TERMINATED,,PHASE1,6.0,ACTUAL,Yale University,,2.0,,Covid-19. Relocation of trainee/investigator. Covid-19.,f,,,,t,t,f,,,t,,,,,,,,2024-10-17 03:15:13.372527,2024-10-17 03:15:13.372527,OTHER,,,,,,,2021,0.0
NCT03461861,,2018-02-26,2022-04-28,,2023-06-30,2018-03-05,2018-03-12,ACTUAL,2023-06-30,2023-07-03,ACTUAL,,,,2023-06-30,2023-07-03,ACTUAL,2019-04-11,ACTUAL,2019-04-11,2023-06,2023-06-30,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,,One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis,Network-Level Mechanisms for Preclinical Alzheimer's Disease Development,Network-Level Mechanisms for Preclinical Alzheimer's Disease Development,COMPLETED,,PHASE2,26.0,ACTUAL,Medical College of Wisconsin,"26 total patients were enrolled in the project, and 25 total patients were included in analysis. One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis.",2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,OTHER,,,,,,,2021,1.0
NCT05198362,,2022-01-05,,,2022-12-09,2022-01-05,2022-01-20,ACTUAL,,,,,,,2022-12-09,2022-12-13,ACTUAL,2021-12-28,ACTUAL,2021-12-28,2022-12,2022-12-31,2022-12-09,ACTUAL,2022-12-09,2022-12-09,ACTUAL,2022-12-09,,INTERVENTIONAL,PWS,,Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome,"A Phase 2b, Double-blind, Randomized, Placebo-controlled, Multi-center, 16-week Dose Finding, Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Prader-Willi Syndrome",WITHDRAWN,,PHASE2,0.0,ACTUAL,Saniona,,4.0,,Due to financial considerations Sponsor is unable to complete the trial and assess the planned objectives/endpoints. No subjects have been randomized to treatment in the clinical trial and the decision therefore has no safety concern for patients,f,,,,t,t,f,,,,,,Following completion of Tesomet clinical development,,,YES,The Sponsor will consider requests from qualified researchers for access to TM006 study materials,2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,INDUSTRY,,,,,,,2022,0.0
NCT04367935,,2020-04-26,,,2022-09-06,2020-04-26,2020-04-29,ACTUAL,,,,,,,2022-09-06,2022-09-07,ACTUAL,2021-01-01,ACTUAL,2021-01-01,2022-09,2022-09-30,2022-04-25,ACTUAL,2022-04-25,2022-04-25,ACTUAL,2022-04-25,,INTERVENTIONAL,,,Effect of Pentoxifylline on Endothelial Dysfunction in Patients With Acute Coronary Syndrome,Effect of Pentoxifylline on Endothelial Dysfunction in Patients With Acute Coronary Syndrome: A Pilot Study,COMPLETED,,PHASE2/PHASE3,43.0,ACTUAL,Ain Shams University,,2.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,OTHER,,,,,,,2022,0.0
NCT04027946,,2019-07-19,2023-05-24,,2024-03-25,2019-07-19,2019-07-22,ACTUAL,2023-06-28,2023-07-18,ACTUAL,,,,2024-03-25,2024-04-16,ACTUAL,2019-09-11,ACTUAL,2019-09-11,2024-03,2024-03-31,2023-12-22,ACTUAL,2023-12-22,2020-06-17,ACTUAL,2020-06-17,,INTERVENTIONAL,,"Although 3 participants were screen failures, data collected for all (6) participants enrolled is shown here.",LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC),A Phase II Study of LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC),TERMINATED,,PHASE2,6.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,Study was terminated due to slow accrual.,f,,,,f,t,f,,,,,,Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing Plan (GDS) plan for as long as database is active.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.,,YES,"All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).",2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,NIH,,,,,,,2023,0.0
NCT03156621,,2017-05-15,2021-04-23,2020-09-25,2021-06-07,2017-05-15,2017-05-17,ACTUAL,2021-06-07,2021-06-29,ACTUAL,2021-06-07,2021-06-29,ACTUAL,2021-06-07,2021-06-29,ACTUAL,2017-10-03,ACTUAL,2017-10-03,2021-06,2021-06-30,2020-02-13,ACTUAL,2020-02-13,2019-09-27,ACTUAL,2019-09-27,,INTERVENTIONAL,ODYSSEY HoFH,,Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH),"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Homozygous Familial Hypercholesterolemia",COMPLETED,,PHASE3,69.0,ACTUAL,Regeneron Pharmaceuticals,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,INDUSTRY,,,,,,,2020,1.0
NCT03389750,,2017-12-19,2023-05-25,,2023-08-11,2017-12-26,2018-01-04,ACTUAL,2023-08-11,2023-09-07,ACTUAL,,,,2023-08-11,2023-09-07,ACTUAL,2018-03-15,ACTUAL,2018-03-15,2023-08,2023-08-31,2023-06-28,ACTUAL,2023-06-28,2022-06-15,ACTUAL,2022-06-15,,INTERVENTIONAL,,Baseline demographics include all participants who were randomized/enrolled.,A Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists.,"A Randomized, Double-Blind, Placebo- and Active-Controlled, Crossover Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists in Physically Dependent Opioid Users With Moderate-to-Severe Opioid Use Disorder",COMPLETED,,PHASE2,16.0,ACTUAL,New York State Psychiatric Institute,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,OTHER,,,,,,,2023,1.0
NCT03019588,,2017-01-11,2022-06-21,,2022-06-21,2017-01-11,2017-01-12,ESTIMATED,2022-06-21,2023-03-30,ACTUAL,,,,2022-06-21,2023-03-30,ACTUAL,2017-02-16,ACTUAL,2017-02-16,2022-06,2022-06-30,2021-06-29,ACTUAL,2021-06-29,2021-06-29,ACTUAL,2021-06-29,,INTERVENTIONAL,,,Efficacy and Safety Study of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-line Therapy With Platinum and Fluoropyrimidine (MK-3475-063/KEYNOTE-063),"A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine",TERMINATED,,PHASE3,94.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,Business Reasons,f,,,,t,f,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,INDUSTRY,,,,,,,2021,0.0
NCT04091438,,2019-09-13,2022-11-17,,2022-11-17,2019-09-13,2019-09-16,ACTUAL,2022-11-17,2023-09-26,ACTUAL,,,,2022-11-17,2023-09-26,ACTUAL,2020-01-26,ACTUAL,2020-01-26,2022-11,2022-11-30,2020-11-23,ACTUAL,2020-11-23,2020-11-19,ACTUAL,2020-11-19,,INTERVENTIONAL,,The safety analysis set included all participants who were randomized and received at least 1 dose of the study drug.,A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia,"A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Crossover Study of a Single Intravenous Infusion Dose of TAK-925 in Patients With Idiopathic Hypersomnia",COMPLETED,,PHASE1,28.0,ACTUAL,Takeda,,2.0,,,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,INDUSTRY,,,,,,,2020,1.0
NCT03508453,,2018-04-16,,,2020-05-13,2018-04-16,2018-04-25,ACTUAL,,,,,,,2020-05-13,2020-05-15,ACTUAL,2019-08-15,ESTIMATED,2019-08-15,2020-05,2020-05-31,2021-12-15,ESTIMATED,2021-12-15,2021-05-15,ESTIMATED,2021-05-15,,INTERVENTIONAL,,,IC14 for Treatment of Amyotrophic Lateral Sclerosis,"A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study of IC14 for Treatment of Patients With Rapidly Progressive Motor Neuron Disease",WITHDRAWN,,PHASE2,0.0,ACTUAL,Implicit Bioscience,,2.0,,Study will not be conducted due to lack of funding,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,INDUSTRY,,,,,,,2021,0.0
NCT02545127,,2015-08-26,2023-11-02,,2024-01-15,2015-09-08,2015-09-09,ESTIMATED,2024-01-15,2024-02-07,ACTUAL,,,,2024-01-15,2024-02-07,ACTUAL,2021-05-28,ACTUAL,2021-05-28,2022-11,2022-11-30,2022-11-11,ACTUAL,2022-11-11,2022-11-11,ACTUAL,2022-11-11,,INTERVENTIONAL,MERMAID,,Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely,"A Randomized, Double-blind, Placebo-controlled, Multicenter Trial Exploring the Efficacy and Safety of Intra-nasal Administration of Merotocin in Increasing Milk Production in Maternal Subjects With Preterm Delivery and Inadequate Milk Production",TERMINATED,,PHASE2,4.0,ACTUAL,Ferring Pharmaceuticals,,2.0,,The trial was prematurely terminated. Termination was not because of safety concerns but due to slow recruitment.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,INDUSTRY,,,,,,,2022,0.0
NCT04679818,,2020-12-17,2024-03-01,,2024-06-18,2020-12-17,2020-12-22,ACTUAL,2024-06-18,2024-06-21,ACTUAL,,,,2024-06-18,2024-06-21,ACTUAL,2020-12-30,ACTUAL,2020-12-30,2024-05,2024-05-31,2023-01-10,ACTUAL,2023-01-10,2022-12-30,ACTUAL,2022-12-30,,INTERVENTIONAL,,,Postoperative Consequences of Intraoperative NOL Titration,Postoperative Consequences of Intraoperative NOL Titration,COMPLETED,,PHASE3,72.0,ACTUAL,The Cleveland Clinic,,2.0,,,f,,,,f,f,t,t,,,,,,,,,,2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,OTHER,,,,,,,2023,1.0
NCT04333654,,2020-04-01,,,2022-04-21,2020-04-02,2020-04-03,ACTUAL,,,,,,,2022-04-21,2022-04-25,ACTUAL,2020-04-12,ACTUAL,2020-04-12,2022-04,2022-04-30,2020-05-26,ACTUAL,2020-05-26,2020-05-26,ACTUAL,2020-05-26,,INTERVENTIONAL,,,Hydroxychloroquine in Outpatient Adults With COVID-19,"A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study of Hydroxychloroquine in Outpatient Adults With COVID-19",TERMINATED,,PHASE1,8.0,ACTUAL,Sanofi,,2.0,,Rate of enrollment too slow to allow completion in a reasonable timeframe,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,INDUSTRY,,,,,,,2020,0.0
NCT05007509,,2021-08-12,,,2023-02-28,2021-08-12,2021-08-16,ACTUAL,,,,,,,2023-02-28,2023-03-01,ACTUAL,2021-08-16,ACTUAL,2021-08-16,2023-02,2023-02-28,2022-09-30,ACTUAL,2022-09-30,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,,,Safety and Immunogenicity Study of Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Adult Healthy Volunteers (COVID-19),A Phase I/IIa Study to Evaluate Safety and Immunogenicity of Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Adult Healthy Volunteers,COMPLETED,,PHASE1/PHASE2,30.0,ACTUAL,"Laboratorios Hipra, S.A.",,2.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,To be decided,2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,INDUSTRY,,,,,,,2022,1.0
NCT04560309,,2020-09-07,2022-04-11,,2023-11-09,2020-09-17,2020-09-23,ACTUAL,2023-11-09,2023-11-13,ACTUAL,,,,2023-11-09,2023-11-13,ACTUAL,2021-01-01,ACTUAL,2021-01-01,2023-11,2023-11-30,2021-11-23,ACTUAL,2021-11-23,2021-10-30,ACTUAL,2021-10-30,,INTERVENTIONAL,,,Role of Glutamine as Myocardial Protector in Elective On-Pump CABG Surgery With Low EF,Role of Glutamine as Myocardial Protector in Elective On-Pump Coronary Artery Bypass Graft Surgery With Low Ejection Fraction,COMPLETED,,PHASE3,60.0,ACTUAL,National Cardiovascular Center Harapan Kita Hospital Indonesia,This study has some limitations. Limitations includes the sampling time of right atrial appendage tissue which was only at 5 minutes after CPB. Right atrial appendage tissue was used for apoptotic index assessment using TUNEL staining. Right atrial appendage tissue could not be sampled at 6 hours after CPB because sternal closure was performed prior to 6 hours.,2.0,,,f,,,,t,f,f,,,,,,Data will be made available after publication until 36 months following article publication,Researchers needs to state their aims of analyses and provide a methodologically sound proposal. Proposals should be directed to the corresponding author.,,YES,Individual deidentified participant data reported in this study will be made available on request after publication and ending 36 months following article publication. Researchers needs to state their aims of analyses and provide a methodologically sound proposal. Proposals should be directed to the corresponding author.,2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,OTHER,,,,,,,2021,1.0
NCT03364686,,2017-11-22,2022-03-01,,2022-03-29,2017-11-30,2017-12-06,ACTUAL,2022-03-29,2022-04-21,ACTUAL,,,,2022-03-29,2022-04-21,ACTUAL,2019-09-16,ACTUAL,2019-09-16,2022-03,2022-03-31,2021-06-29,ACTUAL,2021-06-29,2021-03-02,ACTUAL,2021-03-02,,INTERVENTIONAL,,,Transfusion of Biotin-Labeled Red Blood Cells,Transfusion of Biotin-Labeled Red Blood Cells for the Evaluation of Genetic Factors That Contribute to Donor Differences in Red Blood Cell Storage and Post-Transfusion Red Blood Cell Recovery,TERMINATED,,PHASE2,6.0,ACTUAL,University of Pittsburgh,The clinical trial was terminated early due to challenges with enrollment and lack of study coordinator support. Early termination leading to small numbers of subjects analyzed.,1.0,,Due to enrollment challenges related to COVID and lack of coordinator support,f,,,,t,t,f,,,,,,,,,,,2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,OTHER,,,,,,,2021,0.0
NCT04983498,,2021-07-20,,,2021-11-30,2021-07-20,2021-07-30,ACTUAL,,,,,,,2021-11-30,2021-12-15,ACTUAL,2021-09-01,ESTIMATED,2021-09-01,2021-11,2021-11-30,2022-01-01,ESTIMATED,2022-01-01,2021-12-01,ESTIMATED,2021-12-01,,INTERVENTIONAL,,,Enhanced Recovery Pathway for Endoscopy,Evaluation of an Enhanced Recovery Pathway for Endoscopy Patients Receiving Moderate Sedation,WITHDRAWN,,PHASE4,0.0,ACTUAL,Northwestern University,,2.0,,Investigator left organization before study initiated.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,OTHER,,,,,,,2022,0.0
NCT05431907,,2022-06-08,,,2024-04-15,2022-06-22,2022-06-24,ACTUAL,,,,,,,2024-04-15,2024-04-17,ACTUAL,2022-06-29,ACTUAL,2022-06-29,2024-04,2024-04-30,2024-03-14,ACTUAL,2024-03-14,2024-03-14,ACTUAL,2024-03-14,,INTERVENTIONAL,,,Phase 1/2 Study Evaluating Safety and Potential Efficacy of Allocetra-OTS Via Pressurized Intra-Peritoneal Aerosol Chemotherapy as Add-on to Standard of Care Chemotherapy for Treatment of Peritoneal Metastasis,Phase 1/2 Study Evaluating Safety and Potential Efficacy of Allocetra-OTS Via Pressurized Intra-Peritoneal Aerosol Chemotherapy as Add-on to Standard of Care Chemotherapy for Treatment of Peritoneal Metastasis,TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,Enlivex Therapeutics RDO Ltd.,,2.0,,Sponsor decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,INDUSTRY,,,,,,,2024,0.0
NCT04066244,,2019-08-21,,,2024-07-25,2019-08-21,2019-08-26,ACTUAL,,,,,,,2024-07-25,2024-07-26,ACTUAL,2019-12-30,ACTUAL,2019-12-30,2024-07,2024-07-31,2024-02-01,ACTUAL,2024-02-01,2024-02-01,ACTUAL,2024-02-01,,INTERVENTIONAL,,,Study of Safety and of the Mechanism of BLZ945 in ALS Patients,"An Open-label, Adaptive Design Study in Patients With Amyotrophic Lateral Sclerosis (ALS) to Characterize Safety, Tolerability and Brain Microglia Response, as Measured by TSPO Binding, Following Multiple Doses of BLZ945 Using Positron Emission Tomography (PET) With the Radioligand [11C]-PBR28",TERMINATED,,PHASE2,28.0,ACTUAL,Novartis,,8.0,,Study terminated after assessment of potential benefit-risk from available data,f,,,,f,t,f,,,,,,,,,UNDECIDED,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-17 03:21:36.842642,2024-10-17 03:21:36.842642,INDUSTRY,,,,,,,2024,0.0
NCT03931785,,2019-04-22,2021-02-19,,2021-02-19,2019-04-25,2019-04-30,ACTUAL,2021-02-19,2021-03-12,ACTUAL,,,,2021-02-19,2021-03-12,ACTUAL,2019-05-01,ACTUAL,2019-05-01,2021-02,2021-02-28,2020-03-11,ACTUAL,2020-03-11,2020-02-26,ACTUAL,2020-02-26,,INTERVENTIONAL,,Safety Population: all participants who received at least one dose of study drug,A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome,"A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Study of MD-7246 Administered Orally for 12 Weeks to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome",COMPLETED,,PHASE2,515.0,ACTUAL,"Ironwood Pharmaceuticals, Inc.",,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-17 03:27:53.016507,2024-10-17 03:27:53.016507,INDUSTRY,,,,,,,2020,1.0
NCT03400956,,2018-01-05,2021-03-24,2020-03-17,2022-06-29,2018-01-15,2018-01-17,ACTUAL,2021-04-28,2021-04-30,ACTUAL,2020-03-31,2020-04-06,ACTUAL,2022-06-29,2022-06-30,ACTUAL,2018-01-24,ACTUAL,2018-01-24,2022-06,2022-06-30,2021-06-30,ACTUAL,2021-06-30,2019-03-23,ACTUAL,2019-03-23,,INTERVENTIONAL,,"Participants in Full analysis set (FAS) was analyzed. The FAS consisted of all randomized subjects, excluding randomized subjects who did not start treatment Period 1 (never received study drug) due to the study being temporarily paused, including 96 participants.",Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4),"A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",TERMINATED,,PHASE3,103.0,ACTUAL,Bayer,"* The trial was terminated earlier than planned. It was sufficiently advanced to allow for meaningful analysis.~* In many subjects, follow up phase was longer than the planned one.~* Safety evaluations were not limited to the planned timepoints.",3.0,,"Due to a change in the development program, the study was closed prematurely.",f,,,,f,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,INDUSTRY,,,,,,,2021,0.0
NCT03862053,,2019-03-01,,,2020-10-07,2019-03-01,2019-03-05,ACTUAL,,,,,,,2020-10-07,2020-10-09,ACTUAL,2020-01-01,ESTIMATED,2020-01-01,2020-10,2020-10-31,2020-10-07,ESTIMATED,2020-10-07,2020-10-07,ACTUAL,2020-10-07,,INTERVENTIONAL,,,Manuka Eye Droops for Treatment of Allergy,A Phase 4 Study to Assess the Clinical Efficacy and Safety of Manuka Eye Drops for Treatment of Allergy,WITHDRAWN,,PHASE4,0.0,ACTUAL,Toyos Clinic,,2.0,,not enough time to complete trial;covid,f,,,,f,t,f,,,,,,,,,UNDECIDED,"If requested, data records without identifying patient information could be shared",2024-10-17 03:27:53.016507,2024-10-17 03:27:53.016507,OTHER,,,,,,,2020,0.0
NCT03956355,,2019-05-16,2022-06-21,2020-10-07,2022-09-16,2019-05-17,2019-05-20,ACTUAL,2022-09-16,2022-10-13,ACTUAL,2022-09-16,2022-10-13,ACTUAL,2022-09-16,2022-10-13,ACTUAL,2019-05-21,ACTUAL,2019-05-21,2022-09,2022-09-30,2020-05-26,ACTUAL,2020-05-26,2020-05-26,ACTUAL,2020-05-26,,INTERVENTIONAL,,,Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001),A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Plaque Psoriasis in Adults,COMPLETED,,PHASE3,510.0,ACTUAL,"Dermavant Sciences, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,INDUSTRY,,,,,,,2020,1.0
NCT04055389,,2019-08-07,,,2022-02-23,2019-08-12,2019-08-13,ACTUAL,,,,,,,2022-02-23,2022-03-10,ACTUAL,2021-01-01,ACTUAL,2021-01-01,2022-02,2022-02-28,2022-02-22,ACTUAL,2022-02-22,2022-02-22,ACTUAL,2022-02-22,,INTERVENTIONAL,PiVoT,,Preventing de Novo Portal Vein Thrombosis With Antithrombin-III in Patients With Cirrhosis,"Preventing de Novo Portal Vein Thrombosis With Antithrombin-III in Patients With Cirrhosis: A Randomized, Double-blinded, Placebo - Controlled Trial (PiVoT-AC Trial)",WITHDRAWN,,PHASE1,0.0,ACTUAL,Milton S. Hershey Medical Center,,2.0,,Challenges with recruitment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:27:53.016507,2024-10-17 03:27:53.016507,OTHER,,,,,,,2022,0.0
NCT03770403,,2018-11-16,2023-06-21,,2023-06-21,2018-12-07,2018-12-10,ACTUAL,2023-06-21,2023-07-14,ACTUAL,,,,2023-06-21,2023-07-14,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2023-06,2023-06-30,2022-06-30,ACTUAL,2022-06-30,2022-06-23,ACTUAL,2022-06-23,,INTERVENTIONAL,ADAPT+,The Safety Analysis set consisted of all participants who rolled over from ARGX-113-1704 and received \>=1 dose or part of a dose of efgartigimod in this study.,A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.,"A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness",COMPLETED,,PHASE3,151.0,ACTUAL,argenx,,1.0,,,t,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,INDUSTRY,,NCT04777734,APPROVED_FOR_MARKETING,,,,2022,1.0
NCT03381729,,2017-12-13,2022-05-18,,2023-04-20,2017-12-18,2017-12-22,ACTUAL,2022-05-18,2023-02-16,ACTUAL,,,,2023-04-20,2023-04-24,ACTUAL,2017-12-14,ACTUAL,2017-12-14,2023-04,2023-04-30,2021-11-18,ACTUAL,2021-11-18,2021-11-18,ACTUAL,2021-11-18,,INTERVENTIONAL,STRONG,Safety Analysis Set: All participants given an AVXS-101 intrathecal injection. Participants were analyzed according to actual dose received.,Study of Intrathecal Administration of Onasemnogene Abeparvovec-xioi for Spinal Muscular Atrophy,"Phase I, Open-Label, Dose Comparison Study of AVXS-101 for Sitting But Non-ambulatory Patients With Spinal Muscular Atrophy",TERMINATED,,PHASE1,32.0,ACTUAL,Novartis,"A comparison of the results from this study to the results from the natural history observational study (Pediatric Neuromuscular Clinical Research Network (PNCR), Finkel et al, 2014) are included in the Novartis Clinical Trial Results, as a historical control. These full results are available via this link: https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17933",3.0,,"Based upon overall strategic objectives within the broader intrathecal clinical development program, Novartis Gene Therapies decided to terminate the study early.",f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,INDUSTRY,,,,,,,2021,0.0
NCT04212065,,2019-12-19,,,2020-10-09,2019-12-24,2019-12-26,ACTUAL,,,,,,,2020-10-09,2020-10-14,ACTUAL,2020-02-21,ACTUAL,2020-02-21,2020-10,2020-10-31,2020-09-01,ACTUAL,2020-09-01,2020-09-01,ACTUAL,2020-09-01,,INTERVENTIONAL,,,Long Acting Subcutaneous vs Short Acting Sublingual Buprenorphine in Pregnant and Lactating Women,Long Acting Subcutaneous Compared to Short Acting Sublingual Buprenorphine Administration in Pregnant and Lactating Women,WITHDRAWN,,PHASE4,0.0,ACTUAL,Ohio State University,,2.0,,closed due to new safety concerns of subcutaneous buprenorphine in pregnant patients,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 03:27:53.016507,2024-10-17 03:27:53.016507,OTHER,,,,,,,2020,0.0
NCT03682393,,2018-09-18,,,2022-03-29,2018-09-21,2018-09-24,ACTUAL,,,,,,,2022-03-29,2022-04-07,ACTUAL,2020-01-01,ACTUAL,2020-01-01,2022-03,2022-03-31,2022-12-31,ESTIMATED,2022-12-31,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,MitralPOCS,,Post-operative Corticosteroid Treatment After Mitral Valve Surgery,Does Post-operative Corticosteroid Treatment Prevent New-onset Atrial Fibrillation After Mitral Valve Surgery?,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Kuopio University Hospital,,2.0,,the study never started,f,,,,f,f,f,,,f,,,,,,NO,IPD are not to be shared with other researchers.,2024-10-17 03:27:53.016507,2024-10-17 03:27:53.016507,OTHER,,,,,,,2022,0.0
NCT03782831,,2018-12-19,,,2019-04-30,2018-12-19,2018-12-20,ACTUAL,,,,,,,2019-04-30,2019-05-02,ACTUAL,2018-12-11,ACTUAL,2018-12-11,2018-12,2018-12-31,2020-06-01,ESTIMATED,2020-06-01,2019-12-01,ESTIMATED,2019-12-01,,INTERVENTIONAL,,,TACE Plus PD-1 Antibody vs TACE Alone for Unresectable HCC,Transarterial Chemoembolization Plus Programmed Cell Death Protein-1 Antibody Versus Transarterial Chemoembolization Alone for Unresectable Hepatocellular Carcinoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,Sun Yat-sen University,,2.0,,No participants enrolled,f,,,,t,f,f,,,,,,,,,,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,OTHER,,,,,,,2020,0.0
NCT01546753,,2012-03-01,2021-12-03,,2023-04-19,2012-03-06,2012-03-07,ESTIMATED,2023-04-19,2023-05-12,ACTUAL,,,,2023-04-19,2023-05-12,ACTUAL,2012-04-27,ACTUAL,2012-04-27,2023-04,2023-04-30,2020-07-02,ACTUAL,2020-07-02,2015-07-02,ACTUAL,2015-07-02,,INTERVENTIONAL,WOIT,,Walnut Oral Immunotherapy for Tree Nut Allergy,Walnut Oral Immunotherapy for Tree Nut Allergy,COMPLETED,,PHASE1/PHASE2,22.0,ACTUAL,University of Arkansas,Small sample size High screen failure rate High level of oropharyngeal symptoms Anxiety resulting in early termination Dosing fatigue with daily dosing Requirement for multiple food challenges in multi-tree nut assessment,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 18:03:23.937454,2024-10-15 18:03:23.937454,OTHER,,,,,,,2020,1.0
NCT04996004,,2021-08-02,,,2024-04-10,2021-08-02,2021-08-09,ACTUAL,,,,,,,2024-04-10,2024-04-11,ACTUAL,2021-06-22,ACTUAL,2021-06-22,2024-04,2024-04-30,2023-12-07,ACTUAL,2023-12-07,2023-12-07,ACTUAL,2023-12-07,,INTERVENTIONAL,TTI-621-03,,A Study to Learn About the Study Medicine (Called Ontorpacept or TTI-621) Given Alone and in Combination With Doxorubicin in People With Leiomyosarcoma,A Phase I/II Study of TTI-621 in Combination With Doxorubicin in Patients With Unresectable or Metastatic High-Grade Leiomyosarcoma,TERMINATED,,PHASE2,75.0,ACTUAL,Pfizer,,4.0,,Pfizer decided to terminate the study for administrative reasons. The termination was neither due to safety concerns nor a request from the regulatory authorities.,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,INDUSTRY,,,,,,,2023,0.0
NCT04652414,,2020-11-24,,,2023-02-06,2020-12-01,2020-12-03,ACTUAL,,,,,,,2023-02-06,2023-02-08,ACTUAL,2020-12-01,ACTUAL,2020-12-01,2023-02,2023-02-28,2022-07-30,ACTUAL,2022-07-30,2022-07-30,ACTUAL,2022-07-30,,INTERVENTIONAL,,,Corticosteroids in Community Acquired Pneumonia,Corticosteroid Treatment for Community-Acquired Pneumonia to Improve Long-term Cognition: A Pilot Randomized Controlled Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,Limited enrollment due to the COVID-19 pandemic. Sponsor withdrew funding.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,OTHER,,,,,,,2022,0.0
NCT04839562,,2021-04-06,2023-12-06,,2024-03-01,2021-04-08,2021-04-09,ACTUAL,2024-03-01,2024-03-04,ACTUAL,,,,2024-03-01,2024-03-04,ACTUAL,2021-08-06,ACTUAL,2021-08-06,2024-03,2024-03-31,2023-01-27,ACTUAL,2023-01-27,2023-01-27,ACTUAL,2023-01-27,,INTERVENTIONAL,,,A Controlled Study of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD) in Adults,Solriamfetol for ADHD in Adults: A Double-Blind Placebo Controlled Pilot Study,COMPLETED,,PHASE2/PHASE3,66.0,ACTUAL,Massachusetts General Hospital,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,OTHER,,,,,,,2023,1.0
NCT06177574,,2023-12-07,,,2023-12-18,2023-12-18,2023-12-20,ACTUAL,,,,,,,2023-12-18,2023-12-20,ACTUAL,2020-10-27,ACTUAL,2020-10-27,2023-12,2023-12-31,2023-10-30,ACTUAL,2023-10-30,2023-10-30,ACTUAL,2023-10-30,,INTERVENTIONAL,BIC-NOW,,Study of Bictegravir/Emtricitavine/Tenofovir Alafenamide in HIV-1 Infected naïve Patients Using Test and Treat Stategy Rapid-initiation Model of Care: BIC-NOW Clinical Trial (BIC-NOW),Study of Bictegravir/Emtricitavine/Tenofovir Alafenamide in HIV-1 Infected naïve Patients Using Test and Treat Stategy Rapid-initiation Model of Care: BIC-NOW Clinical Trial (BIC-NOW),COMPLETED,,PHASE4,208.0,ACTUAL,University Hospital Virgen de las Nieves,,1.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,OTHER,,,,,,,2023,1.0
NCT05338580,,2022-04-14,,,2024-04-11,2022-04-14,2022-04-21,ACTUAL,,,,,,,2024-04-11,2024-04-15,ACTUAL,2023-12-31,ACTUAL,2023-12-31,2024-04,2024-04-30,2023-12-31,ACTUAL,2023-12-31,2023-12-31,ACTUAL,2023-12-31,,INTERVENTIONAL,,,Clinical Trial of TJ271 Injection Combined With Pembrolizumab in the Treatment of Advanced Solid Tumors,"A Multi-center, Open-label Phase II Clinical Trial of TJ271 Injection in Combination With Pembrolizumab in Chinese Patients With Advanced Solid Tumors",WITHDRAWN,,PHASE2,0.0,ACTUAL,"TJ Biopharma Co., Ltd.",,1.0,,Company Development strategy adjustment,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-17 03:27:53.016507,2024-10-17 03:27:53.016507,INDUSTRY,,,,,,,2023,0.0
NCT03720392,,2018-10-24,2021-09-27,,2021-11-03,2018-10-24,2018-10-25,ACTUAL,2021-11-03,2021-12-01,ACTUAL,,,,2021-11-03,2021-12-01,ACTUAL,2019-01-15,ACTUAL,2019-01-15,2021-11,2021-11-30,2020-05-28,ACTUAL,2020-05-28,2020-05-28,ACTUAL,2020-05-28,,INTERVENTIONAL,,,Fecal Microbiota Transplantation (FMT) in Recipients After Allogeneic Hematopoietic Cell Transplantation (HCT),A Phase 2 Study of Fecal Microbiota Transplantation (FMT) in Recipients After Allogeneic Hematopoietic Cell Transplantation (HCT),TERMINATED,,PHASE2,8.0,ACTUAL,Massachusetts General Hospital,,2.0,,Terminated due to sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,OTHER,,,,,,,2020,0.0
NCT03985878,,2019-06-11,2023-07-25,,2023-07-25,2019-06-11,2019-06-14,ACTUAL,2023-07-25,2023-08-18,ACTUAL,,,,2023-07-25,2023-08-18,ACTUAL,2019-06-26,ACTUAL,2019-06-26,2023-07,2023-07-31,2022-08-31,ACTUAL,2022-08-31,2022-08-31,ACTUAL,2022-08-31,,INTERVENTIONAL,,Safety Set: all participants who received eteplirsen.,"A Study to Evaluate Safety, Tolerability, and Efficacy of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) Who Have Completed Study 4658-102 (NCT03218995)","An Open-Label Safety, Tolerability, and Efficacy Study of Eteplirsen in Patients With Duchenne Muscular Dystrophy Who Have Completed Study 4658-102",TERMINATED,,PHASE2,15.0,ACTUAL,"Sarepta Therapeutics, Inc.","In an effort to reduce clinical trial burden on participants while ensuring continued treatment if desired, pending commercial availability of eteplirsen, participants were either transitioned to a post-trial access program or another Sarepta study, or they declined further treatment.",1.0,,"Participants were either transitioned to a post-trial access program or another Sarepta study, or they declined further treatment. There are no safety concerns with Eteplirsen.",f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,INDUSTRY,,,,,,,2022,0.0
NCT03255330,,2017-08-15,,,2019-03-05,2017-08-18,2017-08-21,ACTUAL,,,,,,,2019-03-05,2019-03-07,ACTUAL,2017-10,ESTIMATED,2017-10-31,2019-03,2019-03-31,2020-08,ESTIMATED,2020-08-31,2020-02,ESTIMATED,2020-02-29,,INTERVENTIONAL,GabaNeuBol,,The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma,The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma,WITHDRAWN,,PHASE3,0.0,ACTUAL,Masaryk University,,2.0,,no participant enrolled,f,,,,f,f,f,,,,,,,,,,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,OTHER,,,,,,,2020,0.0
NCT04648241,,2020-11-09,2023-02-15,,2023-02-15,2020-11-23,2020-12-01,ACTUAL,2023-02-15,2023-11-22,ACTUAL,,,,2023-02-15,2023-11-22,ACTUAL,2021-01-18,ACTUAL,2021-01-18,2023-02,2023-02-28,2022-02-21,ACTUAL,2022-02-21,2022-02-21,ACTUAL,2022-02-21,,INTERVENTIONAL,,Safety analysis population included all enrolled participants who received at least 1 dose of the investigational product.,"Study to Evaluate the Immunogenicity, Safety, and Tolerability of a Tick-Borne Encephalitis (TBE) Vaccine in Healthy Japanese Participants 1 Year of Age and Older","A PHASE 3, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A TICK-BORNE ENCEPHALITIS VACCINE IN HEALTHY JAPANESE PARTICIPANTS 1 YEAR OF AGE AND OLDER",COMPLETED,,PHASE3,165.0,ACTUAL,Pfizer,,2.0,,,f,,,,f,f,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 03:27:53.016507,2024-10-17 03:27:53.016507,INDUSTRY,,,,,,,2022,1.0
NCT03412890,,2018-01-19,2023-11-13,2020-12-02,2024-04-15,2018-01-19,2018-01-29,ACTUAL,2024-04-15,2024-05-09,ACTUAL,,2024-05-09,ACTUAL,2024-04-15,2024-05-09,ACTUAL,2017-10-19,ACTUAL,2017-10-19,2024-04,2024-04-30,2021-01-13,ACTUAL,2021-01-13,2020-01-21,ACTUAL,2020-01-21,,INTERVENTIONAL,,Extension Safety Population: all enrolled participants who received any amount of open-label study drug in the open-label extension study.,LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids,"LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids",COMPLETED,,PHASE3,477.0,ACTUAL,Myovant Sciences GmbH,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:27:53.016507,2024-10-17 03:27:53.016507,INDUSTRY,,,,,,,2021,1.0
NCT04918797,,2021-05-18,,,2022-08-17,2021-06-02,2021-06-09,ACTUAL,,,,,,,2022-08-17,2022-08-18,ACTUAL,2021-05-26,ACTUAL,2021-05-26,2022-08,2022-08-31,2022-01-25,ACTUAL,2022-01-25,2021-08-15,ACTUAL,2021-08-15,,INTERVENTIONAL,COVAXIN-Peds,,COVAXIN in a Pediatric Cohort,"A Phase II/III, Open Label, Multicenter Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®) in Healthy Volunteers Ages ≤18 to ≥ 2 Years.",COMPLETED,,PHASE2/PHASE3,525.0,ACTUAL,Bharat Biotech International Limited,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 03:27:53.016507,2024-10-17 03:27:53.016507,INDUSTRY,,,,,,,2022,1.0
NCT02536183,,2015-08-13,,,2023-08-28,2015-08-27,2015-08-31,ESTIMATED,,,,,,,2023-08-28,2023-08-29,ACTUAL,2016-10,,2016-10-31,2023-08,2023-08-31,2022-10,ACTUAL,2022-10-31,2022-10,ACTUAL,2022-10-31,,INTERVENTIONAL,,,A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors,"A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin (LTLD, ThermoDox®) and Magnetic Resonance-Guided High Intensity Focused Ultrasound (MR-HIFU) for Relapsed or Refractory Solid Tumors in Children, Adolescents, and Young Adults",TERMINATED,,PHASE1,2.0,ACTUAL,Children's National Research Institute,,2.0,,low accrual,f,,,,t,,,,,,,,,,,,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,OTHER,,,,,,,2022,0.0
NCT04772742,,2021-02-23,,,2022-10-27,2021-02-23,2021-02-26,ACTUAL,,,,,,,2022-10-27,2022-10-31,ACTUAL,2021-02-17,ACTUAL,2021-02-17,2022-10,2022-10-31,2022-09-30,ACTUAL,2022-09-30,2022-05-23,ACTUAL,2022-05-23,,INTERVENTIONAL,Sunlight,,Eptinezumab in Adults With Migraine and Medication Overuse Headache,"Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine in Patients With a Dual Diagnosis of Migraine and Medication Overuse Headache",COMPLETED,,PHASE3,193.0,ACTUAL,H. Lundbeck A/S,,2.0,,,f,,,,t,f,f,,,,,,,,,YES,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,INDUSTRY,,,,,,,2022,1.0
NCT03513445,,2018-04-12,,,2022-08-16,2018-04-30,2018-05-01,ACTUAL,,,,,,,2022-08-16,2022-08-19,ACTUAL,2018-06-01,ESTIMATED,2018-06-01,2022-08,2022-08-31,2022-09,ESTIMATED,2022-09-30,2022-03,ESTIMATED,2022-03-31,,INTERVENTIONAL,,,Peri-Incisional Drug Injection in Lumbar Spine Surgery,Efficacy of Peri-Incisional Multimodal Drug Injection in Reducing Post-Operative Pain Following Lumbar Spine Surgery,WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Minnesota,,2.0,,No participants enrolled,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,OTHER,,,,,,,2022,0.0
NCT02933671,,2016-09-30,2022-06-29,2021-06-16,2022-06-29,2016-10-12,2016-10-14,ESTIMATED,2022-06-29,2022-07-19,ACTUAL,2021-06-16,2021-06-18,ACTUAL,2022-06-29,2022-07-19,ACTUAL,2017-08-01,ACTUAL,2017-08-01,2022-06,2022-06-30,2020-03-17,ACTUAL,2020-03-17,2020-03-16,ACTUAL,2020-03-16,,INTERVENTIONAL,,,Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty,Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty,TERMINATED,,PHASE4,11.0,ACTUAL,Duke University,,2.0,,Study halted prematurely and will not resume; participants are no longer being examined or receiving any intervention.,f,,,,f,t,f,,,f,,,,,,NO,Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,OTHER,,,,,,,2020,0.0
NCT06630572,,2018-01-18,,,2024-10-03,2024-10-03,2024-10-08,ACTUAL,,,,,,,2024-10-03,2024-10-08,ACTUAL,2021-04-03,ACTUAL,2021-04-03,2024-08,2024-08-31,2024-08-01,ACTUAL,2024-08-01,2022-04-03,ACTUAL,2022-04-03,,INTERVENTIONAL,,,Rifaximin in Cirrhosis: Effects on Endotoxin and Haemostatic Indexes,"Rifaximin Blunted Higher Levels of Endotoxin in Cirrhosis Patients: a Randomized, Double Blind, Short Term Interventional Trial",TERMINATED,,PHASE4,20.0,ACTUAL,University of Roma La Sapienza,,2.0,,Because drug is expired,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 17:01:34.860787,2024-10-15 17:01:34.860787,OTHER,,,,,,,2024,0.0
NCT03835728,,2019-02-05,2021-08-25,,2021-09-21,2019-02-07,2019-02-11,ACTUAL,2021-09-21,2021-10-19,ACTUAL,,,,2021-09-21,2021-10-19,ACTUAL,2019-01-22,ACTUAL,2019-01-22,2021-09,2021-09-30,2020-10-02,ACTUAL,2020-10-02,2020-10-02,ACTUAL,2020-10-02,,INTERVENTIONAL,,,Efficacy of Ocrelizumab in Autoimmune Encephalitis,Exploratory Study of Efficacy of Ocrelizumab in Autoimmune Encephalitis,TERMINATED,,PHASE2,3.0,ACTUAL,University of Texas Southwestern Medical Center,Early termination of trial due to inadequate recruitment. Small numbers of subjects prevents definitive analysis of results,2.0,,Failed to meet target enrollment and study was discontinued,f,,,,f,t,f,,,f,,,,,,YES,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,OTHER,,,,,,,2020,0.0
NCT03467152,,2018-03-09,2022-06-08,2021-04-07,2022-07-29,2018-03-09,2018-03-15,ACTUAL,2022-07-29,2022-08-01,ACTUAL,2022-07-29,2022-08-01,ACTUAL,2022-07-29,2022-08-01,ACTUAL,2018-05-04,ACTUAL,2018-05-04,2022-07,2022-07-31,2020-04-15,ACTUAL,2020-04-15,2020-04-15,ACTUAL,2020-04-15,,INTERVENTIONAL,,The safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post randomization safety assessment.,"Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies","A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies",COMPLETED,,PHASE2,326.0,ACTUAL,Eisai Inc.,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:02:29.301169,2024-10-15 07:02:29.301169,INDUSTRY,,,,,,,2020,1.0
NCT04422275,,2020-06-05,,,2021-02-25,2020-06-05,2020-06-09,ACTUAL,,,,,,,2021-02-25,2021-03-02,ACTUAL,2021-06-01,ESTIMATED,2021-06-01,2021-02,2021-02-28,2023-12-31,ESTIMATED,2023-12-31,2023-06-01,ESTIMATED,2023-06-01,,INTERVENTIONAL,Co-STAR,,Coronavirus Smell Therapy for Anosmia Recovery,Coronavirus Smell Therapy for Anosmia Recovery,WITHDRAWN,,PHASE2,0.0,ACTUAL,Washington University School of Medicine,,4.0,,Funding not received,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 07:07:42.976613,2024-10-15 07:07:42.976613,OTHER,,,,,,,2023,0.0
NCT03593473,,2018-06-05,2024-04-29,,2024-06-05,2018-07-09,2018-07-20,ACTUAL,2024-04-29,2024-05-24,ACTUAL,,,,2024-06-05,2024-06-27,ACTUAL,2019-02-07,ACTUAL,2019-02-07,2024-04,2024-04-30,2023-07-25,ACTUAL,2023-07-25,2023-07-25,ACTUAL,2023-07-25,,INTERVENTIONAL,,,Inhaled Oxytocin and HPA Axis Reactivity,The Psychobiology of Resilience in Mother-child Pairs: Inhaled Oxytocin and HPA Axis Reactivity,COMPLETED,,PHASE2,109.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,,f,,,,f,t,f,,,,,,"Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and executes a data use/sharing agreement with the University of North Carolina (UNC).","Individual level data sharing will be subject to local IRB approval, individual written informed consents, and national law",http://mmi.web.unc.edu,YES,Data will be shared according to the most recent NIH guidelines.,2024-10-15 07:07:42.976613,2024-10-15 07:07:42.976613,OTHER,,,,,,,2023,1.0
NCT05271279,,2022-02-23,,,2022-10-31,2022-03-04,2022-03-09,ACTUAL,,,,,,,2022-10-31,2022-11-02,ACTUAL,2021-12-24,ACTUAL,2021-12-24,2022-03,2022-03-31,2022-08-29,ACTUAL,2022-08-29,2022-08-29,ACTUAL,2022-08-29,,INTERVENTIONAL,,,A Study of OVV-01 Injection in Combination With IBR900 Cell Injection in Patients With Advanced Malignant Tumors,"A Single-Arm, Open-Label, Investigator-Initiated Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Oncolytic Virus Injection (OVV-01) in Combination With IBR900 Cell Injection in Patients With Advanced Malignant Tumors",TERMINATED,,EARLY_PHASE1,2.0,ACTUAL,Beijing Boren Hospital,,1.0,,Research and development strategy adjustment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 07:07:42.976613,2024-10-15 07:07:42.976613,OTHER,,,,,,,2022,0.0
NCT04566445,,2020-09-09,,,2024-07-03,2020-09-22,2020-09-28,ACTUAL,,,,,,,2024-07-03,2024-07-08,ACTUAL,2020-09-28,ACTUAL,2020-09-28,2024-07,2024-07-31,2024-06-10,ACTUAL,2024-06-10,2024-06-10,ACTUAL,2024-06-10,,INTERVENTIONAL,,,HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005,"HORIZON: A Phase II, Open-label, Outcomes-assessor Masked, Multicentre, Randomised, Controlled Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration",TERMINATED,,PHASE2,255.0,ACTUAL,Gyroscope Therapeutics Limited,,3.0,,The study was terminated due to the interim analysis demonstrating lack of treatment efficacy.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:07:42.976613,2024-10-15 07:07:42.976613,INDUSTRY,,,,,,,2024,0.0
NCT03584373,,2018-06-29,2023-10-16,,2023-11-27,2018-06-29,2018-07-12,ACTUAL,2023-11-27,2023-12-18,ACTUAL,,,,2023-11-27,2023-12-18,ACTUAL,2018-07-27,ACTUAL,2018-07-27,2023-10,2023-10-31,2022-03-23,ACTUAL,2022-03-23,2022-03-23,ACTUAL,2022-03-23,,INTERVENTIONAL,PO-NOA,,Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery.,Pain Outcomes of Non-opioid Analgesia After Ureteroscopy or Percutaneous Nephrolithotomy for Nephrolithiasis: a Prospective Randomized Controlled Trial.,COMPLETED,,PHASE3,119.0,ACTUAL,Montefiore Medical Center,,2.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 07:07:42.976613,2024-10-15 07:07:42.976613,OTHER,,,,,,,2022,1.0
NCT02692651,,2016-02-23,2022-02-23,,2022-03-24,2016-02-23,2016-02-26,ESTIMATED,2022-03-24,2022-03-25,ACTUAL,,,,2022-03-24,2022-03-25,ACTUAL,2017-05-01,ACTUAL,2017-05-01,2022-03,2022-03-31,2021-06-23,ACTUAL,2021-06-23,2021-05-23,ACTUAL,2021-05-23,,INTERVENTIONAL,,,A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections,A Comparison of Fidaxomicin and Oral Vancomycin for the Treatment of Clostridium Difficile Infection (CDI) in Hospitalized Patients Receiving Concomitant Antibiotics for the Treatment of Concurrent Systemic Infections,COMPLETED,,PHASE4,144.0,ACTUAL,University of Michigan,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 07:07:42.976613,2024-10-15 07:07:42.976613,OTHER,,,,,,,2021,1.0
NCT04726098,,2021-01-23,,,2021-10-19,2021-01-26,2021-01-27,ACTUAL,,,,,,,2021-10-19,2021-10-20,ACTUAL,2021-01-15,ACTUAL,2021-01-15,2021-10,2021-10-31,2021-08-31,ACTUAL,2021-08-31,2021-08-31,ACTUAL,2021-08-31,,INTERVENTIONAL,HIGHLOWDEXA,,Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19,Efficacy of Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19,COMPLETED,,PHASE4,198.0,ACTUAL,Hospital Clinico Universitario de Santiago,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 07:07:42.976613,2024-10-15 07:07:42.976613,OTHER,,,,,,,2021,1.0
NCT02642939,,2015-12-11,,,2020-10-15,2015-12-28,2015-12-30,ESTIMATED,,,,,,,2020-10-15,2020-10-19,ACTUAL,2015-12,ACTUAL,2015-12-31,2020-10,2020-10-31,2020-10-15,ACTUAL,2020-10-15,2020-10-15,ACTUAL,2020-10-15,,INTERVENTIONAL,,,Study of Oral Mifepristone as Salvage Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer,A Phase II Study of Treatment With Oral Mifepristone as Salvage Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Two or More Previous Chemotherapy Regimens,TERMINATED,,PHASE2,3.0,ACTUAL,"Check, Jerome H., M.D., Ph.D.",,1.0,,Lack of enrollment,f,,,,f,,,,,,,,1 year after completion of study,,,YES,See below,2024-10-15 07:07:42.976613,2024-10-15 07:07:42.976613,INDIV,,,,,,,2020,0.0
NCT03777176,,2018-12-13,2023-09-01,2021-09-02,2023-11-23,2018-12-13,2018-12-17,ACTUAL,2023-11-23,2023-12-13,ACTUAL,,2023-12-13,ACTUAL,2023-11-23,2023-12-13,ACTUAL,2019-02-07,ACTUAL,2019-02-07,2023-11,2023-11-30,2020-10-05,ACTUAL,2020-10-05,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,,,A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism,"A Two-Period, Open-label Trial Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children With Congenital Hyperinsulinism",COMPLETED,,PHASE3,32.0,ACTUAL,Zealand Pharma,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:27:53.016507,2024-10-17 03:27:53.016507,INDUSTRY,,,,,,,2020,1.0
NCT04998201,,2021-08-03,,2024-02-08,2024-04-16,2021-08-03,2021-08-10,ACTUAL,,,,,2024-02-12,ACTUAL,2024-04-16,2024-04-18,ACTUAL,2021-09-28,ACTUAL,2021-09-28,2024-04,2024-04-30,2023-08-14,ACTUAL,2023-08-14,2023-02-10,ACTUAL,2023-02-10,,INTERVENTIONAL,MUIR,,Study of ARO-APOC3 in Adults With Mixed Dyslipidemia,"A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults With Mixed Dyslipidemia",COMPLETED,,PHASE2,353.0,ACTUAL,Arrowhead Pharmaceuticals,,5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:07:42.976613,2024-10-15 07:07:42.976613,INDUSTRY,,,,,,,2023,1.0
NCT02359175,,2015-02-04,,,2023-06-26,2015-02-06,2015-02-09,ESTIMATED,,,,,,,2023-06-26,2023-06-27,ACTUAL,2015-02,ACTUAL,2015-02-28,2023-06,2023-06-30,2023-03-22,ACTUAL,2023-03-22,2019-01-24,ACTUAL,2019-01-24,,INTERVENTIONAL,SEAVATS,,Supplementary Epidural Analgesia in Video-Assisted Thoracic Surgery (VATS) - The SEAVATS Study,Supplementary Epidural Analgesia in Video-Assisted Thoracic Surgery (VATS) - The SEAVATS Study,COMPLETED,,PHASE4,161.0,ACTUAL,Odense University Hospital,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 07:07:42.976613,2024-10-15 07:07:42.976613,OTHER,,,,,,,2023,1.0
NCT02151604,,2014-05-21,2021-09-20,,2022-05-23,2014-05-29,2014-05-30,ESTIMATED,2022-05-23,2023-02-23,ACTUAL,,,,2022-05-23,2023-02-23,ACTUAL,2014-04-23,ACTUAL,2014-04-23,2021-09,2021-09-30,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,"Not all participants have had their baseline measurements taken due to a number of interim ethics approved study amendments and some logistic issues. But age, sex, CT and HPXMRI were acquired for all patients enrolled in the study.",Hyperpolarized Xenon Gas MR Imaging in NSCLC Radiotherapy,A Study to Determine Regional Lung Function in Patients With Non-small Cell Lung Cancer (NSCLC) Undergoing Radiotherapy Using Hyperpolarized Xenon Gas MR Imaging,COMPLETED,,PHASE2,22.0,ACTUAL,Oxford University Hospitals NHS Trust,3 patients were recruited prior a substantial amendment was put in place thus were excluded from the analysis due to different study objectives being in place at that time.~4 patients were not able to breath hold during the MRI scan and therefore good quality image scans of their lungs could not be obtained on those occasions. The scans were excluded from the analysis.,1.0,,,f,,,,f,f,,,,,,,,,,,,2024-10-17 03:27:53.016507,2024-10-17 03:27:53.016507,OTHER,,,,,,,2020,1.0
NCT04792970,,2021-03-08,2023-07-10,,2023-09-01,2021-03-08,2021-03-11,ACTUAL,2023-09-01,2023-09-28,ACTUAL,,,,2023-09-01,2023-09-28,ACTUAL,2021-03-18,ACTUAL,2021-03-18,2023-09,2023-09-30,2022-10-07,ACTUAL,2022-10-07,2022-10-07,ACTUAL,2022-10-07,,INTERVENTIONAL,,,Randomized Controlled Trial of Talc Instillation In Addition To Daily Drainage Through a Tunneled Pleural Catheter to Improve Rates of Outpatient Pleurodesis in Patients With Malignant Pleural Effusion,Randomized Controlled Trial of Talc Instillation In Addition To Daily Drainage Through a Tunneled Pleural Catheter to Improve Rates of Outpatient Pleurodesis in Patients With Malignant Pleural Effusion - The ASAP II Trial,TERMINATED,,PHASE4,4.0,ACTUAL,Duke University,,2.0,,Study enrollment not met,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 03:27:53.016507,2024-10-17 03:27:53.016507,OTHER,,,,,,,2022,0.0
NCT02927314,,2016-09-25,,,2020-03-16,2016-10-06,2016-10-07,ESTIMATED,,,,,,,2020-03-16,2020-03-17,ACTUAL,2017-11-27,ACTUAL,2017-11-27,2020-03,2020-03-31,2020-03-01,ACTUAL,2020-03-01,2020-03-01,ACTUAL,2020-03-01,,INTERVENTIONAL,,,A Study of the Efficacy and Safety of CF102 in the Treatment of Non-Alcoholic Fatty Liver Disease,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of the Efficacy and Safety of CF102 in the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH)",COMPLETED,,PHASE2,60.0,ACTUAL,Can-Fite BioPharma,,3.0,,,f,,,,,f,f,,,f,,,,,,,,2024-10-17 03:27:53.016507,2024-10-17 03:27:53.016507,INDUSTRY,,,,,,,2020,1.0
NCT03872011,,2019-03-04,,,2021-09-21,2019-03-09,2019-03-12,ACTUAL,,,,,,,2021-09-21,2021-09-23,ACTUAL,2019-02-19,ACTUAL,2019-02-19,2021-09,2021-09-30,2021-09-20,ACTUAL,2021-09-20,2021-09-20,ACTUAL,2021-09-20,,INTERVENTIONAL,,,"Vitamin C, Thiamine and Hydrocortisone for the Treatment of Septic Shock","Initiation of Vitamin C, Thiamine and Hydrocortisone Therapy for Septic Shock in Adults: A Randomized Clinical Trial",COMPLETED,,PHASE3,408.0,ACTUAL,Northern Jiangsu People's Hospital,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 07:07:42.976613,2024-10-15 07:07:42.976613,OTHER,,,,,,,2021,0.0
NCT03390101,,2017-12-28,2021-02-11,,2022-05-11,2017-12-28,2018-01-04,ACTUAL,2021-04-16,2021-05-11,ACTUAL,,,,2022-05-11,2022-06-01,ACTUAL,2017-12-26,ACTUAL,2017-12-26,2022-05,2022-05-31,2022-01-20,ACTUAL,2022-01-20,2018-07-30,ACTUAL,2018-07-30,,INTERVENTIONAL,BCD-085-7,All randomized subjects,"An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis","An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis",COMPLETED,,PHASE3,213.0,ACTUAL,Biocad,,3.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 07:07:42.976613,2024-10-15 07:07:42.976613,INDUSTRY,,,,,,,2022,1.0
NCT03822351,,2018-12-10,2024-07-01,,2024-10-04,2019-01-29,2019-01-30,ACTUAL,2024-10-04,2024-10-08,ACTUAL,,,,2024-10-04,2024-10-08,ACTUAL,2018-12-19,ACTUAL,2018-12-19,2024-10,2024-10-31,2023-07-18,ACTUAL,2023-07-18,2023-07-18,ACTUAL,2023-07-18,,INTERVENTIONAL,COAST,The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group,Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC,"A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab (MEDI4736) Alone or in Combination With Novel Agents in Subjects With Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer (COAST)",COMPLETED,,PHASE2,189.0,ACTUAL,MedImmune LLC,,3.0,,,,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,INDUSTRY,,,,,,,2023,1.0
NCT06489860,,2024-03-05,,,2024-10-01,2024-07-04,2024-07-08,ACTUAL,,,,,,,2024-10-01,2024-10-08,ACTUAL,2024-10-01,ESTIMATED,2024-10-01,2024-10,2024-10-31,2024-10-04,ESTIMATED,2024-10-04,2024-10-02,ESTIMATED,2024-10-02,,INTERVENTIONAL,SARS-CoV-2,,SARS-CoV-2 Safety Study for the Treatment of COVID-19,SARS-CoV-2 Safety Study for the Treatment of COVID-19,WITHDRAWN,,PHASE2,0.0,ACTUAL,"DHA Coffee Co., Ltd",,1.0,,"My record is not overseen by an IRB, I change the Overall Status to Withdrawn.",f,,,,t,f,f,,,,,,,,,NO,"20 -1 g Packets Net Weight 0.70 oz (20 g) Directions: For adults and for Children 1-12 years old. Indication: Treated the SARS-CoV-2 COVID-19 within 20 days Ingredient: Organic Rice 95% and Honey 5% Powder (whole) 1g. Mix one packet with 6.8 fl oz (200 ml) of hot water (220ºF/100ºC) about three minutes until dissolved.~Participants: Use 4 to 5 packets, use one pack each time after two hours. Use within two years from the manufacturing date. Humidification: \<5% Dosage Form: Powder form Dosage Strength: 1.0 G/ 1 Unit, use one pack of 1 g for each time Storage normal conditions in dry, cool and temperature from 15 °C to 32 °C Store in a dry environment (75% humidity).",2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,INDUSTRY,,,,,,,2024,0.0
NCT02781584,,2016-05-20,2022-01-04,,2022-03-07,2016-05-20,2016-05-24,ESTIMATED,2022-01-04,2022-02-02,ACTUAL,,,,2022-03-07,2022-03-16,ACTUAL,2016-06-13,ACTUAL,2016-06-13,2022-03,2022-03-31,2020-12-17,ACTUAL,2020-12-17,2020-12-17,ACTUAL,2020-12-17,,INTERVENTIONAL,,,"Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)","A Proof of Concept, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Regimens in Subjects With Nonalcoholic Steatohepatitis (NASH)",COMPLETED,,PHASE2,220.0,ACTUAL,Gilead Sciences,,13.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,INDUSTRY,,,,,,,2020,1.0
NCT04335201,,2020-03-31,,,2022-07-18,2020-04-02,2020-04-06,ACTUAL,,,,,,,2022-07-18,2022-07-19,ACTUAL,2020-05-20,ACTUAL,2020-05-20,2022-07,2022-07-31,2021-05-28,ACTUAL,2021-05-28,2021-04-07,ACTUAL,2021-04-07,,INTERVENTIONAL,DEFI-VID19,,Defibrotide in COVID-19 Pneumonia,Use of Defibrotide to Reduce Progression of Acute Respiratory Failure Rate in Patients With COVID-19 Pneumonia,COMPLETED,,PHASE2,50.0,ACTUAL,IRCCS San Raffaele,,1.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 07:07:42.976613,2024-10-15 07:07:42.976613,OTHER,,,,,,,2021,1.0
NCT05082155,,2021-10-02,,,2022-05-24,2021-10-14,2021-10-18,ACTUAL,,,,,,,2022-05-24,2022-05-31,ACTUAL,2022-01-01,ACTUAL,2022-01-01,2022-05,2022-05-31,2022-05-24,ACTUAL,2022-05-24,2022-05-24,ACTUAL,2022-05-24,,INTERVENTIONAL,,,Continuous Erector Spinae Plane Blocks to Treat Postoperative Pain After Open Gynecologic Procedures Via a Low Transverse (Pfannenstiel) Incision,"Continuous Erector Spinae Plane Blocks to Treat Postoperative Pain After Open Gynecologic Procedures Via a Low Transverse (Pfannenstiel) Incision: A Randomized, Triple-masked, Placebo-controlled, Split-body Clinical Trial",WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of California, San Diego",,2.0,,surgeons stopped doing procedures,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-17 03:27:53.016507,2024-10-17 03:27:53.016507,OTHER,,,,,,,2022,0.0
NCT03760666,,2018-11-27,2022-03-02,,2022-08-05,2018-11-29,2018-11-30,ACTUAL,2022-08-05,2022-08-08,ACTUAL,,,,2022-08-05,2022-08-08,ACTUAL,2018-12-20,ACTUAL,2018-12-20,2022-08,2022-08-31,2021-02-09,ACTUAL,2021-02-09,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,Data were reported and analyzed by cohort.,A Study of Brequinar in Subjects With Relapsed/Refractory Acute Myeloid Leukemia,"A Phase 1b/2a Open-label, Multi-center Study to Assess the Safety, Efficacy and Pharmacokinetics of Intrapatient Dose-adjusted Brequinar and Inhibition of Dihydroorotate Dehydrogenase (DHODH) in Adult Subjects With AML",TERMINATED,,PHASE1/PHASE2,17.0,ACTUAL,"Clear Creek Bio, Inc.","CCB-01 was a small, open-label study in patients who had exhausted all other therapy options for their relapsed/refractory acute myeloid leukemia (AML). The study was stopped early due to lack of efficacy and inability to recruit new patients during the COVID-19 pandemic.",1.0,,"No efficacy observed, COVID-19 caused sites to shut down",f,,,,f,t,f,,,,,,"Requests for data can be submitted at any time and if the below conditions are met data will be accessible for 12 months, with possible extensions considered.","Requests for data may be made by qualified researchers who plan to engage in rigorous, independent scientific research. Data will be provided following review and approval of a research proposal including a formal statistical analysis plan and execution of a Data Sharing Agreement.",,YES,"Clear Creek Bio is committed to responsible data sharing regarding the clinical trials we sponsor. Data that may be shared include access to anonymized participant and trial level data (analysis data sets), as well as other information (e.g., protocol) as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-17 03:27:53.016507,2024-10-17 03:27:53.016507,INDUSTRY,,,,,,,2021,0.0
NCT04565249,,2020-09-15,2022-09-22,,2022-10-27,2020-09-24,2020-09-25,ACTUAL,2022-10-27,2022-11-17,ACTUAL,,,,2022-10-27,2022-11-17,ACTUAL,2020-10-22,ACTUAL,2020-10-22,2020-09,2020-09-30,2021-08-02,ACTUAL,2021-08-02,2021-06-01,ACTUAL,2021-06-01,,INTERVENTIONAL,,Study was discontinued before completion of enrollment of Dose 1.,"Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19","A Randomized, Double-blind, Dose-ranging, Placebo Controlled, Phase 2a Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19 (INTEGRIS-ARDS)",TERMINATED,,PHASE2,6.0,ACTUAL,"Pliant Therapeutics, Inc.","The study was discontinued prior to completion of enrollment of Dose 1 due to the lack of participant availability following the introduction of COVID-19 vaccines as well as the increased and successful measures to contain the virus leading to a dramatic decrease in the number of severe and critical COVID-19 patients with ARDS. As a result, the study did not reach the target number of participants needed to achieve target power and statistically reliable results.",3.0,,Study halted and will not resume; participants are no longer being examined or receiving intervention,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,INDUSTRY,,,,,,,2021,0.0
NCT04119336,,2019-10-05,2023-06-26,,2023-08-16,2019-10-07,2019-10-08,ACTUAL,2023-08-16,2023-08-21,ACTUAL,,,,2023-08-16,2023-08-21,ACTUAL,2020-02-14,ACTUAL,2020-02-14,2023-08,2023-08-31,2022-03-30,ACTUAL,2022-03-30,2020-11-12,ACTUAL,2020-11-12,,INTERVENTIONAL,,,"Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Myeloma","A Phase II Study of Nivolumab in Combination With Ixazomib, Cyclophosphamide, and Dexamethasone in Relapsed and Refractory Multiple Myeloma",TERMINATED,,PHASE2,2.0,ACTUAL,Massachusetts General Hospital,,1.0,,Study closure initiated by industry funding sponsor for commercial reasons.,f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,MGH - Contact the Partners Innovations team at http://www.partners.org/innovation,http://www.partners.org/innovation,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-17 03:27:53.016507,2024-10-17 03:27:53.016507,OTHER,,,,,,,2022,0.0
NCT04090190,,2019-08-21,2022-08-01,,2022-10-21,2019-09-12,2019-09-16,ACTUAL,2022-09-21,2022-10-03,ACTUAL,,,,2022-10-21,2022-11-15,ACTUAL,2019-10-30,ACTUAL,2019-10-30,2022-10,2022-10-31,2021-10-31,ACTUAL,2021-10-31,2021-05-30,ACTUAL,2021-05-30,,INTERVENTIONAL,,,Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics,Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics,COMPLETED,,PHASE4,20.0,ACTUAL,Brigham and Women's Hospital,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,OTHER,,,,,,,2021,1.0
NCT03586544,,2018-07-02,2021-04-22,,2021-07-20,2018-07-02,2018-07-13,ACTUAL,2021-06-30,2021-07-21,ACTUAL,,,,2021-07-20,2021-07-22,ACTUAL,2018-09-18,ACTUAL,2018-09-18,2021-07,2021-07-31,2021-03-30,ACTUAL,2021-03-30,2020-03-30,ACTUAL,2020-03-30,,INTERVENTIONAL,,Baseline analysis is shown for all randomized participants including the two participants who did not complete the interval warm-up first arm.,Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity,Asthma and Childhood Obesity: Understanding Potential Mechanisms and Identifying Strategies to Improve Respiratory Symptoms,TERMINATED,,PHASE4,34.0,ACTUAL,"University of Nevada, Las Vegas",,2.0,,The study was halted prematurely due to COVID 19.,f,,,,f,t,f,,,f,,,,,,NO,There is no current plan to share individual participant data.,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,OTHER,,,,,,,2021,0.0
NCT04147416,,2019-10-30,,,2022-05-25,2019-10-30,2019-11-01,ACTUAL,,,,,,,2022-05-25,2022-05-27,ACTUAL,2019-11-22,ACTUAL,2019-11-22,2022-05,2022-05-31,2020-07-03,ACTUAL,2020-07-03,2020-05-31,ACTUAL,2020-05-31,,INTERVENTIONAL,,,A Study Evaluating the Efficacy and Safety of HSK3486 for Sedation,"A Multi-center, Open-label, Randomized, Propofol-controlled Study Evaluating the Efficacy and Safety of Intravenous Administration of HSK3486 Injectable Emulsion for Sedation in Intensive Care (ICU) Patients Undergoing Mechanical Ventilation",COMPLETED,,PHASE2,39.0,ACTUAL,"Haisco Pharmaceutical Group Co., Ltd.",,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,INDUSTRY,,,,,,,2020,1.0
NCT03425539,,2018-01-16,2024-07-03,2022-08-02,2024-08-06,2018-02-01,2018-02-07,ACTUAL,2024-08-06,2024-08-09,ACTUAL,,2024-08-09,ACTUAL,2024-08-06,2024-08-09,ACTUAL,2018-06-21,ACTUAL,2018-06-21,2024-08,2024-08-31,2021-09-02,ACTUAL,2021-09-02,2021-08-17,ACTUAL,2021-08-17,,INTERVENTIONAL,MODIFY,,Efficacy and Safety of Lucerastat Oral Monotherapy in Adult Subjects With Fabry Disease,"A Multicenter, dOuble-blind, ranDomized, Placebo-controlled, Parallel-group Study to Determine the effIcacy and Safety of Lucerastat Oral Monotherapy in Adult Subjects With FabrY Disease",COMPLETED,,PHASE3,118.0,ACTUAL,Idorsia Pharmaceuticals Ltd.,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,INDUSTRY,,,,,,,2021,1.0
NCT03302156,,2017-08-18,2023-05-10,,2023-08-08,2017-09-29,2017-10-04,ACTUAL,2023-07-19,2023-08-09,ACTUAL,,,,2023-08-08,2023-09-05,ACTUAL,2017-11-15,ACTUAL,2017-11-15,2023-07,2023-07-31,2020-01-20,ACTUAL,2020-01-20,2020-01-20,ACTUAL,2020-01-20,,INTERVENTIONAL,,"study terminated early, no participants enrolled in dosimetry group",PSMA PET and MRI in Gynecological Cancers,PSMA Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging in Gynecological Cancers,TERMINATED,,PHASE2,15.0,ACTUAL,"University of Wisconsin, Madison","Calculating accuracy, sensitivity and specificity relies on the IHC staining as the gold standard. IHC staining was not done because the study was terminated due to low recruitment and loss of funds. Because the IHC staining was not performed, there is no gold standard by which to perform accuracy, sensitivity and specificity analysis.",3.0,,Slow accrual following suspension per COVID-19,f,,,,t,t,f,,,,,,,,,,,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,OTHER,,,,,,,2020,0.0
NCT04142788,,2019-10-08,,,2023-01-17,2019-10-25,2019-10-29,ACTUAL,,,,,,,2023-01-17,2023-01-19,ACTUAL,2020-07-28,ACTUAL,2020-07-28,2023-01,2023-01-31,2022-12-20,ACTUAL,2022-12-20,2022-12-20,ACTUAL,2022-12-20,,INTERVENTIONAL,RELIEHF,,RELieving Increasing oEdema Due to Heart Failure,"A Phase IV, Registry-based, Randomised, Controlled, Open-label Trial Investigating the Potential for Patiromer-facilitated Use of Higher Doses of MRAs in Addition to Standard Care to Improve Congestion, Well-being, Morbidity and Mortality",TERMINATED,,PHASE4,4.0,ACTUAL,NHS Greater Glasgow and Clyde,,2.0,,"The study was stopped due to low recruitment, which the Steering Committee and funder agreed could not be rectified.",f,,,,t,f,f,,,,,,,,,,,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,OTHER,,,,,,,2022,0.0
NCT02744742,,2016-04-18,,,2022-01-30,2016-04-18,2016-04-20,ESTIMATED,,,,,,,2022-01-30,2022-02-14,ACTUAL,2016-04-18,ACTUAL,2016-04-18,2016-04,2016-04-30,2021-09-30,ACTUAL,2021-09-30,2019-09-30,ACTUAL,2019-09-30,,INTERVENTIONAL,,,"G-CSF+Decitabine+BUCY vs BUCY Conditioning Regimen for RAEB-1, REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT","Granulocyte Colony-stimulating Factor+Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Patients With RAEB-1, RAEB-2 and AML Secondary to MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation",COMPLETED,,PHASE2/PHASE3,202.0,ACTUAL,"Nanfang Hospital, Southern Medical University",,2.0,,,f,,,,t,,,,,,,,,,,YES,,2024-10-15 07:07:42.976613,2024-10-15 07:07:42.976613,OTHER,,,,,,,2021,1.0
NCT02374333,,2015-02-23,,,2021-09-22,2015-02-26,2015-02-27,ESTIMATED,,,,,,,2021-09-22,2021-09-23,ACTUAL,2014-03-25,ACTUAL,2014-03-25,2021-09,2021-09-30,2021-09-02,ACTUAL,2021-09-02,2021-09-02,ACTUAL,2021-09-02,,INTERVENTIONAL,,,Pilot Study of Redirected Autologous T Cells Engineered to Contain Humanized Anti-CD19 in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma Previously Treated With Cell Therapy,Pilot Study of Redirected Autologous T Cells Engineered to Contain Humanized Anti-CD19 Attached to TCRζ and 4-1BB Signaling Domains in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma Previously Treated With Cell Therapy,COMPLETED,,PHASE1,81.0,ACTUAL,University of Pennsylvania,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,OTHER,,,,,,,2021,1.0
NCT04950751,,2021-06-17,,,2021-09-02,2021-06-25,2021-07-06,ACTUAL,,,,,,,2021-09-02,2021-09-10,ACTUAL,2021-08,ESTIMATED,2021-08-31,2021-09,2021-09-30,2022-04,ESTIMATED,2022-04-30,2022-04,ESTIMATED,2022-04-30,,INTERVENTIONAL,,,Immunogenicity and Safety of Adjuvanted SCB-2020S Vaccines in Adults,"An Observer-blind, Randomized, Controlled, Phase 2 Study to Evaluate the Immunogenicity and Safety of Clover Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2020S) in Adults",WITHDRAWN,,PHASE2,0.0,ACTUAL,Clover Biopharmaceuticals AUS Pty Ltd,,5.0,,sponsor decided to withdrawn the study as development strategy has changed,f,,,,t,f,f,,,,,,,,,,,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,INDUSTRY,,,,,,,2022,0.0
NCT04866056,,2021-04-28,,,2022-11-28,2021-04-28,2021-04-29,ACTUAL,,,,,,,2022-11-28,2022-12-01,ACTUAL,2021-09-30,ACTUAL,2021-09-30,2022-11,2022-11-30,2022-06-10,ACTUAL,2022-06-10,2022-06-10,ACTUAL,2022-06-10,,INTERVENTIONAL,,,Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF.,A Multicentric Phase I/II Study of Jaktinib Hydrochloride Tablets in Combination With Azacitidine for Injection in Patients With Myelodysplastic Syndromes(MDS) With Myelofibrosis(MF) or MDS/Myeloproliferative Neoplasms With MF,TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,"Suzhou Zelgen Biopharmaceuticals Co.,Ltd",,1.0,,Corporate policy adjustments,f,,,,f,f,f,,,,,,,,,,,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,INDUSTRY,,,,,,,2022,0.0
NCT03636451,,2018-08-13,2022-09-27,,2023-03-28,2018-08-15,2018-08-17,ACTUAL,2023-03-28,2023-04-20,ACTUAL,,,,2023-03-28,2023-04-20,ACTUAL,2018-10-29,ACTUAL,2018-10-29,2023-03,2023-03-31,2022-09-27,ACTUAL,2022-09-27,2020-12-14,ACTUAL,2020-12-14,,INTERVENTIONAL,,,Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o,Assessing the Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage: a Randomized Controlled Trial,COMPLETED,,PHASE3,114.0,ACTUAL,"University of California, San Diego",Limitations of our study include a lack of variation in the clinical setting for which the dilation and aspiration procedures were performed (outpatient clinics at large academic centers) limiting the generalizability of the study to community care settings. The study was powered to evaluate only a 20-mm difference in pain control within each stratum of the cohort. Larger sample sizes in each stratum could potentially detect a more subtle effect on pain control.,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,OTHER,,,,,,,2022,0.0
NCT01107626,,2010-04-20,2020-12-21,,2023-06-20,2010-04-20,2010-04-21,ESTIMATED,2021-02-01,2021-02-23,ACTUAL,,,,2023-06-20,2023-07-07,ACTUAL,2010-10-25,ACTUAL,2010-10-25,2023-06,2023-06-30,2021-08-17,ACTUAL,2021-08-17,2019-01-31,ACTUAL,2019-01-31,,INTERVENTIONAL,,All registered patients,Bevacizumab or Pemetrexed Disodium Alone or In Combination After Induction Therapy in Treating Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer,"Randomized Phase III Study of Maintenance Therapy With Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC",COMPLETED,,PHASE3,1516.0,ACTUAL,Eastern Cooperative Oncology Group,,3.0,,,f,,,,t,t,f,,,f,,,,,,YES,Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,NETWORK,,,,,,,2021,1.0
NCT02004613,,2013-08-01,2020-12-18,,2021-03-12,2013-12-04,2013-12-09,ESTIMATED,2021-03-12,2021-04-06,ACTUAL,,,,2021-03-12,2021-04-06,ACTUAL,2013-06,ACTUAL,2013-06-30,2021-03,2021-03-31,2020-12-18,ACTUAL,2020-12-18,2018-12,ACTUAL,2018-12-31,,INTERVENTIONAL,Decade,,Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery,Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery,COMPLETED,,PHASE4,798.0,ACTUAL,The Cleveland Clinic,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,OTHER,,,,,,,2020,1.0
NCT04044664,,2019-07-09,2021-11-30,,2022-05-16,2019-08-01,2019-08-05,ACTUAL,2022-04-19,2022-05-13,ACTUAL,,,,2022-05-16,2022-05-17,ACTUAL,2019-01-25,ACTUAL,2019-01-25,2022-05,2022-05-31,2020-08-05,ACTUAL,2020-08-05,2020-08-05,ACTUAL,2020-08-05,,INTERVENTIONAL,,,Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder,A Study to Evaluate the Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder,COMPLETED,,PHASE2,160.0,ACTUAL,Aptinyx,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,INDUSTRY,,,,,,,2020,1.0
NCT03538054,,2018-01-19,2022-06-28,,2022-08-03,2018-05-15,2018-05-25,ACTUAL,2022-08-03,2022-08-26,ACTUAL,,,,2022-08-03,2022-08-26,ACTUAL,2018-06-26,ACTUAL,2018-06-26,2022-08,2022-08-31,2020-03-18,ACTUAL,2020-03-18,2020-03-18,ACTUAL,2020-03-18,,INTERVENTIONAL,,,Dextromethorphan in Fibromyalgia,Dextromethorphan in Fibromyalgia,COMPLETED,,PHASE2,27.0,ACTUAL,University of Alabama at Birmingham,"Medication was tested in a small number of fibromyalgia (FM) patients, limiting generalizability. Length of DXM treatment was only 10 weeks, so it is unclear if the results are durable. We used a single-blind design that could have led to experimenter bias. We relied only on self-reported pain rather than using objective pain assessments.",2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,OTHER,,,,,,,2020,1.0
NCT03568162,,2018-05-31,2022-06-02,,2022-07-26,2018-06-22,2018-06-26,ACTUAL,2022-06-02,2022-06-28,ACTUAL,,,,2022-07-26,2022-08-23,ACTUAL,2018-05-31,ACTUAL,2018-05-31,2022-07,2022-07-31,2021-08-03,ACTUAL,2021-08-03,2020-08-11,ACTUAL,2020-08-11,,INTERVENTIONAL,,Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment group assigned. Two participants randomized to ISB 830 300 mg q4w group discontinued study without receiving any study drug and were excluded from FAS.,Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis,"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of ISB 830 in Adult Subjects With Moderate to Severe Atopic Dermatitis.",COMPLETED,,PHASE2,462.0,ACTUAL,Ichnos Sciences SA,,6.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,INDUSTRY,,,,,,,2021,1.0
NCT03982199,,2019-06-10,2023-06-06,,2024-05-07,2019-06-10,2019-06-11,ACTUAL,2023-07-21,2023-07-24,ACTUAL,,,,2024-05-07,2024-05-16,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2024-05,2024-05-31,2023-05-26,ACTUAL,2023-05-26,2022-06-06,ACTUAL,2022-06-06,,INTERVENTIONAL,CYPRESS,"The Full Analysis Set (FAS) included all randomized participants with a documented vaccine administration, regardless of the occurrence of protocol deviations.",A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older,"A Randomized, Double-blind, Placebo-controlled Phase 2b Study to Assess the Efficacy, Immunogenicity and Safety of an Ad26.RSV.preF-based Regimen in the Prevention of RT PCR-confirmed RSV-mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older",TERMINATED,,PHASE2,5815.0,ACTUAL,Janssen Vaccines & Prevention B.V.,,2.0,,The study was terminated early by the sponsor due to strategic reprioritization reasons.,f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 17:08:29.332887,2024-10-15 17:08:29.332887,INDUSTRY,,,,,,,2023,0.0
NCT04570475,,2020-09-25,,,2024-05-13,2020-09-25,2020-09-30,ACTUAL,,,,,,,2024-05-13,2024-05-16,ACTUAL,2021-09-15,ACTUAL,2021-09-15,2024-05,2024-05-31,2024-05-13,ACTUAL,2024-05-13,2024-05-13,ACTUAL,2024-05-13,,INTERVENTIONAL,,,High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache,"High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache: a Randomized, Double-blind, Placebo Controlled Trial.",TERMINATED,,PHASE3,27.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,Low number met criteria to randomize.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,OTHER,,,,,,,2024,0.0
NCT03357224,,2017-11-23,,,2024-02-21,2017-11-28,2017-11-29,ACTUAL,,,,,,,2024-02-21,2024-02-22,ACTUAL,2018-09-24,ACTUAL,2018-09-24,2024-02,2024-02-29,2022-08-18,ACTUAL,2022-08-18,2021-03-11,ACTUAL,2021-03-11,,INTERVENTIONAL,PARCT,,PARCT: Trial of Atezolizumab in Relapsed/Refractory Cutaneous T Cell Lymphoma (CTCL),Phase II Trial of Atezolizumab (Anti-PD-L1) in the Treatment of Stage IIb-IV Mycosis Fungoides/Sezary Syndrome Patients Relapsed/Refractory After a Previous Systemic Treatment,TERMINATED,,PHASE2,26.0,ACTUAL,European Organisation for Research and Treatment of Cancer - EORTC,,1.0,,Following an urgent safety measure due to toxicity recruitment has been closed prematurely.,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,NETWORK,,,,,,,2022,0.0
NCT03518203,,2018-03-05,2023-05-30,,2023-09-20,2018-05-04,2018-05-08,ACTUAL,2023-09-20,2023-09-21,ACTUAL,,,,2023-09-20,2023-09-21,ACTUAL,2018-08-03,ACTUAL,2018-08-03,2023-08,2023-08-31,2022-06-01,ACTUAL,2022-06-01,2022-04-04,ACTUAL,2022-04-04,,INTERVENTIONAL,,,Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome -Associated Multiple Organ Dysfunction Syndrome in Hematopoietic Stem Cell Transplant Recipients,Early Intervention With Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome (TMA/aHUS)-Associated Multiple Organ Dysfunction Syndrome (MODS) in Hematopoietic Stem Cell Transplant (HCT) Recipients,COMPLETED,,PHASE2,23.0,ACTUAL,"Children's Hospital Medical Center, Cincinnati",,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,OTHER,,,,,,,2022,1.0
NCT02620865,,2015-12-01,2023-01-31,,2023-04-19,2015-12-01,2015-12-03,ESTIMATED,2023-04-19,2023-05-15,ACTUAL,,,,2023-04-19,2023-05-15,ACTUAL,2015-12,,2015-12-31,2023-04,2023-04-30,2021-06-21,ACTUAL,2021-06-21,2021-06-21,ACTUAL,2021-06-21,,INTERVENTIONAL,,,BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer,Phase Ib/II Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs) in Combination With Low Dose IL-2 and GM-CSF,COMPLETED,,PHASE1/PHASE2,2.0,ACTUAL,Barbara Ann Karmanos Cancer Institute,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,OTHER,,,,,,,2021,1.0
NCT04029038,,2019-07-19,,,2023-08-16,2019-07-19,2019-07-23,ACTUAL,,,,,,,2023-08-16,2023-08-21,ACTUAL,2019-05-15,ACTUAL,2019-05-15,2023-08,2023-08-31,2022-11-16,ACTUAL,2022-11-16,2022-11-16,ACTUAL,2022-11-16,,INTERVENTIONAL,,,"Modified Immune Cells (CD19-CD22 CAR T Cells) in Treating Patients With Recurrent or Refractory CD19 Positive, CD22 Positive Leukemia or Lymphoma",Phase I/II Study of Dual CD19-CD22 Chimeric Antigen Receptor (CAR) T Cells in Patients With Advanced CD19+ CD22+ Lymphoid Malignancies,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,0 participant accrual,,,,,f,t,f,,,,,,,,,,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,OTHER,,,,,,,2022,0.0
NCT03862170,,2018-06-28,,,2022-03-15,2019-03-01,2019-03-05,ACTUAL,,,,,,,2022-03-15,2022-03-17,ACTUAL,2015-02-10,ACTUAL,2015-02-10,2022-03,2022-03-31,2023-02,ESTIMATED,2023-02-28,2023-02,ESTIMATED,2023-02-28,,INTERVENTIONAL,BRP30,,Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer,Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer: a Phase III Randomized Trial,SUSPENDED,,PHASE3,255.0,ESTIMATED,CR-CSSS Champlain-Charles-Le Moyne,,3.0,,Covid-19 pandemic,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,OTHER,,,,,,,2023,0.0
NCT02265731,,2014-10-15,,,2021-07-29,2014-10-15,2014-10-16,ESTIMATED,,,,,,,2021-07-29,2021-08-02,ACTUAL,2014-09-22,ACTUAL,2014-09-22,2021-07,2021-07-31,2021-03-12,ACTUAL,2021-03-12,2021-03-12,ACTUAL,2021-03-12,,INTERVENTIONAL,,,Study Evaluating Venetoclax in Subjects With Hematological Malignancies,"A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Japanese Subjects With Hematological Malignancies",COMPLETED,,PHASE1/PHASE2,38.0,ACTUAL,AbbVie,,4.0,,,f,,,,t,f,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,INDUSTRY,,,,,,,2021,1.0
NCT03755440,,2018-11-22,,,2022-09-16,2018-11-26,2018-11-28,ACTUAL,,,,,,,2022-09-16,2022-09-21,ACTUAL,2018-12-01,ACTUAL,2018-12-01,2022-09,2022-09-30,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,PD-1 Antibody in EBV Positive Metastatic Gastric Cancer Patients.,Phase II Study of PD-1 Antibody SHR-1210 in EBV Positive Metastatic Gastric Cancer Patients.,COMPLETED,,PHASE2,6.0,ACTUAL,Sun Yat-sen University,,1.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,OTHER,,,,,,,2020,1.0
NCT04102449,,2019-09-23,,,2021-05-11,2019-09-23,2019-09-25,ACTUAL,,,,,,,2021-05-11,2021-05-13,ACTUAL,2020-07-01,ACTUAL,2020-07-01,2021-05,2021-05-31,2022-02,ESTIMATED,2022-02-28,2022-02,ESTIMATED,2022-02-28,,INTERVENTIONAL,PSA-ULTRA,,Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast,Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast,WITHDRAWN,,PHASE4,0.0,ACTUAL,Medical University of Graz,,1.0,,Funding stopped,f,,,,,t,f,,,t,,,,,,,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,OTHER,,,,,,,2022,0.0
NCT04088188,,2019-09-11,2024-03-08,,2024-05-03,2019-09-11,2019-09-12,ACTUAL,2024-04-08,2024-05-02,ACTUAL,,,,2024-05-03,2024-05-06,ACTUAL,2021-01-25,ACTUAL,2021-01-25,2024-04,2024-04-30,2023-12-01,ACTUAL,2023-12-01,2023-12-01,ACTUAL,2023-12-01,,INTERVENTIONAL,,Arms A and B are reported together to maintain patient deidentification and privacy.,Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma,"A Phase I, Multi-Center, Open Label, Dose De-Escalation and Expansion Study of Gemcitabine and Cisplatin With AG120 or Pemigatinib for Advanced Cholangiocarcinoma",TERMINATED,,PHASE1,8.0,ACTUAL,Academic and Community Cancer Research United,,2.0,,Low accrual,,,,,f,t,f,,,f,,,,,,,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,OTHER,,,,,,,2023,0.0
NCT05043987,,2021-08-30,,,2023-09-03,2021-09-09,2021-09-14,ACTUAL,,,,,,,2023-09-03,2023-09-07,ACTUAL,2022-11-16,ACTUAL,2022-11-16,2023-09,2023-09-30,2022-11-16,ACTUAL,2022-11-16,2022-11-16,ACTUAL,2022-11-16,,INTERVENTIONAL,,,"Dose Escalation and Expansion Study of CPO102, an Anti-claudin 18.2 ADC in Patients With Advanced Cancers","A Phase 1, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate Safety of CPO102, an Anti-claudin 18.2 Antibody-MMAE Drug Conjugate Administered Intravenously in Patients With Advanced Pancreatic and Gastric Cancers",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Conjupro Biotherapeutics, Inc.",,3.0,,New IND sponsor to initiate a separate study,f,,,,f,t,f,,,,,,,,,NO,Undecided,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,INDUSTRY,,,,,,,2022,0.0
NCT04258410,,2020-02-04,,,2022-10-05,2020-02-04,2020-02-06,ACTUAL,,,,,,,2022-10-05,2022-10-10,ACTUAL,2022-09,ESTIMATED,2022-09-30,2022-10,2022-10-31,2024-01,ESTIMATED,2024-01-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,QUICKENED,,Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency,Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency (QUICKENED) Feasibility Study in Older Women,WITHDRAWN,,PHASE4,0.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,Per PI: Never went to IRB Never recruited anyone Never resubmitted the score NIH application I am leaving the institution,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,OTHER,,,,,,,2024,0.0
NCT03686813,,2018-09-24,2022-10-28,,2022-10-28,2018-09-25,2018-09-27,ACTUAL,2022-10-28,2022-11-22,ACTUAL,,,,2022-10-28,2022-11-22,ACTUAL,2019-07-15,ACTUAL,2019-07-15,2022-10,2022-10-31,2021-10-29,ACTUAL,2021-10-29,2021-10-29,ACTUAL,2021-10-29,,INTERVENTIONAL,,,Sildenafil for Swimming-Induced Pulmonary Edema (SIPE) Prevention,Sildenafil for Prevention of Swimming-Induced Pulmonary Edema (SIPE),COMPLETED,,PHASE2,18.0,ACTUAL,Duke University,,2.0,,,f,,,,f,t,f,,,t,,,,,,UNDECIDED,Data will be published in the open literature,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,OTHER,,,,,,,2021,1.0
NCT04605588,,2020-10-26,2022-04-06,,2022-05-03,2020-10-26,2020-10-28,ACTUAL,2022-05-03,2022-05-05,ACTUAL,,,,2022-05-03,2022-05-05,ACTUAL,2020-12-02,ACTUAL,2020-12-02,2022-05,2022-05-31,2021-02-04,ACTUAL,2021-02-04,2021-01-17,ACTUAL,2021-01-17,,INTERVENTIONAL,TriACT,,A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19,"A Triple Combination Antiviral Coronavirus Therapy (TriACT) RCT Comparing Nitazoxanide, Ribavirin and Hydroxychloroquine vs. Placebo",TERMINATED,,PHASE2,7.0,ACTUAL,"Rutgers, The State University of New Jersey",,2.0,,Lack of participants willing to enroll,f,,,,t,t,f,,,,,,,,,,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,OTHER,,,,,,,2021,0.0
NCT05076656,,2021-09-15,,,2022-07-21,2021-09-29,2021-10-13,ACTUAL,,,,,,,2022-07-21,2022-07-22,ACTUAL,2019-06-10,ACTUAL,2019-06-10,2021-07,2021-07-31,2022-06-30,ACTUAL,2022-06-30,2020-10-17,ACTUAL,2020-10-17,,INTERVENTIONAL,EPI-MICROBIO,,Epigenetic and Microbiota Modifications,Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction,COMPLETED,,EARLY_PHASE1,22.0,ACTUAL,Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud,,3.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,OTHER,,,,,,,2022,1.0
NCT03386929,,2017-12-14,2023-10-20,,2023-11-29,2017-12-20,2017-12-29,ACTUAL,2023-11-29,2023-12-18,ACTUAL,,,,2023-11-29,2023-12-18,ACTUAL,2017-11-29,ACTUAL,2017-11-29,2023-11,2023-11-30,2022-12-29,ACTUAL,2022-12-29,2022-12-29,ACTUAL,2022-12-29,,INTERVENTIONAL,SPRING,,Survival Prolongation by Rationale Innovative Genomics,A Proof of Concept Study to Explore Safety and Efficacy of Tri-therapy Approach in Advanced/Metastatic NSCLC and Retrospectively Assess the Ability of Integrated Genomics and Transcriptomics to Match Patients to the Combination,TERMINATED,,PHASE1/PHASE2,15.0,ACTUAL,Worldwide Innovative Network Association,The trial was early terminated after the end of its Phase 1 due to lack of funding. As a result it was not possible to analyse the objectives of the study.,1.0,,The SPRING trial had to be early terminated at the end of the Phase 1 portion of the study due to the absence of funding necessary for the performance of the Phase 2.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,OTHER,,,,,,,2022,0.0
NCT02013037,,2013-12-11,2021-01-06,,2021-04-30,2013-12-11,2013-12-17,ESTIMATED,2021-04-30,2021-05-03,ACTUAL,,,,2021-04-30,2021-05-03,ACTUAL,2012-11,,2012-11-30,2021-04,2021-04-30,2020-04-30,ACTUAL,2020-04-30,2019-12-30,ACTUAL,2019-12-30,,INTERVENTIONAL,DUET,"The trial enrolled a total of 36 sensitized participants age ≥ 18 years with a panel reactive antibody (PRA) ≥70% at any time prior to study screening. Participants were included in the eculizumab treatment group if at least one DSA at MFI≥ 5000 was crossed but with negative prospective complement-dependent cytotoxicity (CDC) crossmatch. The eculizumab group consisted of 20 consecutive recipients transplanted between June 2, 2013 and July 31, 2018.",The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation,"The De-novo Use of Eculizumab Alongside Conventional Therapy in Presensitized Patients Receiving Cardiac Transplantation: An Open-Label, Investigator-Initiated Pilot Trial: [The DUET Cardiac Trial]",COMPLETED,,PHASE3,36.0,ACTUAL,Cedars-Sinai Medical Center,,1.0,,,f,,,,t,t,f,,,f,,,Data will be available following publication and ending 3 years following article publication.,Data will be available to investigators whose proposed used of the data has been approved by Cedars Sinai IRB.,,YES,Individual participant data that supports the results of the study after deidentification and in accordance with Cedars Sinai data sharing agreements.,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,OTHER,,,,,,,2020,1.0
NCT04346888,,2020-04-13,,,2023-03-06,2020-04-14,2020-04-15,ACTUAL,,,,,,,2023-03-06,2023-03-08,ACTUAL,2020-07-23,ACTUAL,2020-07-23,2023-03,2023-03-31,2021-08-24,ACTUAL,2021-08-24,2021-08-24,ACTUAL,2021-08-24,,INTERVENTIONAL,,,"A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacodynamic and Pharmacokinetic of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis",COMPLETED,,PHASE2,30.0,ACTUAL,Harbour BioMed (Guangzhou) Co. Ltd.,,3.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,INDUSTRY,,,,,,,2021,1.0
NCT03784963,,2018-12-03,2021-05-27,,2021-06-22,2018-12-19,2018-12-24,ACTUAL,2021-06-22,2021-07-13,ACTUAL,,,,2021-06-22,2021-07-13,ACTUAL,2019-01-23,ACTUAL,2019-01-23,2021-06,2021-06-30,2020-07-15,ACTUAL,2020-07-15,2020-07-15,ACTUAL,2020-07-15,,INTERVENTIONAL,,Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.,Efficacy of Omega-3 Fatty Acid Therapy in Preventing Gastrointestinal Bleeding in Patients With CF-LVAD,Open-Label Prospective Randomized Control Trial to Investigate the Efficacy of Omega-3 Fatty Acid Therapy in Preventing Gastrointestinal Bleeding in Patients With Continuous-Flow Left Ventricular Assist Device,TERMINATED,,PHASE1/PHASE2,35.0,ACTUAL,University of Chicago,Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.,4.0,,Low enrollment,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,OTHER,,,,,,,2020,0.0
NCT03055767,,2017-02-08,2023-06-02,,2023-09-22,2017-02-13,2017-02-16,ACTUAL,2023-09-22,2023-10-18,ACTUAL,,,,2023-09-22,2023-10-18,ACTUAL,2017-03-01,ACTUAL,2017-03-01,2023-09,2023-09-30,2020-04-20,ACTUAL,2020-04-20,2018-11-30,ACTUAL,2018-11-30,,INTERVENTIONAL,,"15 subjects randomized into the baseline, double-blind period (cross-over).",Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Study in the Pediatric Pain Population,Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Randomized Double Blinded Placebo Cross-over Study in the Pediatric Pain Population,COMPLETED,,PHASE2,17.0,ACTUAL,"University of California, Irvine","A lack of diversity in subject demographics and age. Didn't control for patients seeking alternative therapies during the study period, nor attempt to control concomitant medications.~Patients with comorbidities can have an impact on the treatment effect. PedMIDAS may not account for seasonal changes or patients with modified school schedules.~Continuation of baseline therapy is a confounding variable. Pain diary records required follow-up. Data collection relied in part on subject recall.",2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,OTHER,,,,,,,2020,1.0
NCT03518112,,2018-04-25,2022-05-17,,2022-11-03,2018-04-25,2018-05-08,ACTUAL,2022-11-03,2022-11-04,ACTUAL,,,,2022-11-03,2022-11-04,ACTUAL,2018-04-18,ACTUAL,2018-04-18,2022-11,2022-11-30,2021-05-27,ACTUAL,2021-05-27,2021-05-27,ACTUAL,2021-05-27,,INTERVENTIONAL,,,Low-Intensity Chemotherapy and Blinatumomab in Treating Patients With Philadelphia Chromosome Negative Relapsed or Refractory Acute Lymphoblastic Leukemia,Phase II Study of the Combination of Low-Intensity Chemotherapy and Blinatumomab in Patients With Philadelphia Chromosome Negative Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL),TERMINATED,,PHASE2,6.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Due to Competing Studies,f,,,,f,t,f,,,,,,,,,,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,OTHER,,,,,,,2021,0.0
NCT03265717,,2017-08-24,,,2020-07-06,2017-08-26,2017-08-29,ACTUAL,,,,,,,2020-07-06,2020-07-08,ACTUAL,2018-07-25,ACTUAL,2018-07-25,2020-07,2020-07-31,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,"DNA Plasmid Encoding a Modified Human Telomerase Reverse Transcriptase (hTERT), Invac-1 in Chronic Lymphocytic Leukemia",A Phase II Study of INVAC-1 as Treatment of Patients With High-risk Chronic Lymphocytic Leukemia,TERMINATED,,PHASE2,26.0,ACTUAL,Invectys,,2.0,,sponsor decision,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,INDUSTRY,,,,,,,2020,0.0
NCT03905109,,2019-04-03,,,2024-07-29,2019-04-04,2019-04-05,ACTUAL,,,,,,,2024-07-29,2024-07-31,ACTUAL,2022-09-19,ESTIMATED,2022-09-19,2024-07,2024-07-31,2022-09-19,ESTIMATED,2022-09-19,2022-09-19,ESTIMATED,2022-09-19,,INTERVENTIONAL,,,Phase 2b/3 Study of ABX464 in Moderate to Severe Active Crohn's Disease Patients,"Phase 2b/3, Randomized, Double Blind, Placebo Controlled Induction Phase Followed by a Maintenance Phase to Evaluate the Efficacy & Safety of ABX464 in Patients With Moderate to Severe Active Crohn's Disease & to Determine the Optimal Dose",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Abivax S.A.,,3.0,,Study design revised and to be found under new NCT06456593 ABX464-202,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 07:07:42.976613,2024-10-15 07:07:42.976613,INDUSTRY,,,,,,,2022,0.0
NCT05070104,,2021-09-17,,,2023-09-11,2021-09-27,2021-10-06,ACTUAL,,,,,,,2023-09-11,2023-09-13,ACTUAL,2023-03-30,ESTIMATED,2023-03-30,2023-09,2023-09-30,2024-11-01,ESTIMATED,2024-11-01,2024-03-01,ESTIMATED,2024-03-01,,INTERVENTIONAL,,,CPI-613 (Devimistat) in Combination With Modified FOLFIRINOX Plus Bevacizumab in Patients With Metastatic Colorectal Cancer,Phase I Study of the First-In-Class Agent CPI-613 (Devimistat) in Combination With Modified FOLFIRINOX Plus Bevacizumab in Patients With Metastatic Colorectal Cancer,WITHDRAWN,,PHASE1,0.0,ACTUAL,Cornerstone Pharmaceuticals,,1.0,,no funding,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,INDUSTRY,,,,,,,2024,0.0
NCT05452174,,2022-06-29,,,2024-04-22,2022-07-05,2022-07-11,ACTUAL,,,,,,,2024-04-22,2024-04-24,ACTUAL,2022-06-13,ACTUAL,2022-06-13,2024-04,2024-04-30,2023-10-29,ACTUAL,2023-10-29,2023-10-29,ACTUAL,2023-10-29,,INTERVENTIONAL,ESNAP,,Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP),Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP),TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,Northwestern University,,1.0,,transfer of PI to new organization,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:07:42.976613,2024-10-15 07:07:42.976613,OTHER,,,,,,,2023,0.0
NCT04860258,,2021-04-22,2022-04-20,,2022-04-20,2021-04-22,2021-04-26,ACTUAL,2022-04-20,2022-05-13,ACTUAL,,,,2022-04-20,2022-05-13,ACTUAL,2021-04-22,ACTUAL,2021-04-22,2022-04,2022-04-30,2021-09-21,ACTUAL,2021-09-21,2021-09-21,ACTUAL,2021-09-21,,INTERVENTIONAL,,The Safety Analysis Set (SAS) consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.,"COVID-19: A Study to Evaluate Safety, Reactogenicity and Immunogenicity of the SARS-CoV-2 mRNA Vaccine CVnCoV in Adults With Co-morbidities","COVID-19: A Phase 3 Multicenter Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Above With Co-morbidities",TERMINATED,,PHASE3,129.0,ACTUAL,CureVac,Participant recruitment was smaller than planned due to early recruitment halt. The Principal Investigators and CureVac decided to terminate the trial early following a change to the risk/benefit profile.,1.0,,The Principal Investigators and CureVac decided to terminate the trial early following a change to the risk/benefit profile.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,INDUSTRY,,,,,,,2021,0.0
NCT05356403,,2022-04-18,,,2024-05-06,2022-04-29,2022-05-02,ACTUAL,,,,,,,2024-05-06,2024-05-07,ACTUAL,2022-08-26,ACTUAL,2022-08-26,2024-05,2024-05-31,2024-02-26,ACTUAL,2024-02-26,2024-02-26,ACTUAL,2024-02-26,,INTERVENTIONAL,,,CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus,"A Multicenter, Randomized, Double-blind, Placebo-controlled 12-Week Study to Evaluate the Safety and Efficacy of Oral Difelikefalin in Advanced Chronic Kidney Disease Subjects With Moderate-to-Severe Pruritus With an up to 52-Week Long-term Extension",TERMINATED,,PHASE3,105.0,ACTUAL,"Cara Therapeutics, Inc.",,2.0,,Corporate decision to discontinue work in advanced chronic kidney disease,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,INDUSTRY,,,,,,,2024,0.0
NCT04511650,,2020-08-07,2022-09-19,,2023-06-06,2020-08-11,2020-08-13,ACTUAL,2023-06-06,2023-06-08,ACTUAL,,,,2023-06-06,2023-06-08,ACTUAL,2020-10-21,ACTUAL,2020-10-21,2023-06,2023-06-30,2021-02-26,ACTUAL,2021-02-26,2021-02-26,ACTUAL,2021-02-26,,INTERVENTIONAL,RESCUE,,Evaluation of the Safety and Efficacy of Razuprotafib in Hospitalized Subjects With Coronavirus Disease 2019,"Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Escalation and Proof-of-Concept Study to Evaluate the Safety and Efficacy of Razuprotafib in Hospitalized Subjects With Coronavirus Disease 2019",TERMINATED,,PHASE2,31.0,ACTUAL,"EyePoint Pharmaceuticals, Inc.",,3.0,,"After completion of Step 1 Part 1, the Sponsor discontinued the study based on challenges associated with recruiting and monitoring patients in the current pandemic environment.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,INDUSTRY,,,,,,,2021,0.0
NCT03861767,,2019-01-21,2024-03-06,2023-09-08,2024-05-24,2019-02-28,2019-03-04,ACTUAL,2024-05-24,2024-06-18,ACTUAL,,2024-06-18,ACTUAL,2024-05-24,2024-06-18,ACTUAL,2019-04-15,ACTUAL,2019-04-15,2024-05,2024-05-31,2022-09-23,ACTUAL,2022-09-23,2022-09-23,ACTUAL,2022-09-23,,INTERVENTIONAL,UPMCREMAP,None of the participants were randomized to the high-dose long course combination of drug dose and preoperative duration.,REMAP Trial for Optimizing Surgical Outcomes at UPMC,"Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Optimizing Surgical Outcomes at UPMC",TERMINATED,,PHASE3,302.0,ACTUAL,University of Pittsburgh,"Recruitment was terminated early and was limited by the COVID-19 pandemic, as such the study is underpowered and could not meet its set goals. No patients fell in the high dose long course group since no participants were randomized to that group",10.0,,Not enough enrollment due to the COVID19 pandemic.,f,,,,t,t,f,,,f,,,Relevant data may be available 1 year following publication,Data access is subject to a methodologically sound proposal and the necessary data sharing agreements.,,YES,"De-identified participant-level data underlying the results reported in journal articles, subject to appropriate security controls, may be available for sharing with other researchers.",2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,OTHER,,,,,,,2022,0.0
NCT03601507,,2018-07-17,2023-12-22,2023-05-08,2024-04-08,2018-07-17,2018-07-26,ACTUAL,2024-04-08,2024-04-17,ACTUAL,,2024-04-17,ACTUAL,2024-04-08,2024-04-17,ACTUAL,2019-03-11,ACTUAL,2019-03-11,2024-04,2024-04-30,2022-05-24,ACTUAL,2022-05-24,2022-05-24,ACTUAL,2022-05-24,,INTERVENTIONAL,,,Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer,"Biomarker Modulation by Alpelisib (BYL719) in Transorally Resectable, HPV-Associated HNSCC: A Phase II Window Trial",TERMINATED,,PHASE2,9.0,ACTUAL,University of Arizona,"This study stopped accrual early as the investigational product (IP) manufacturer, Novartis, terminated the study stopping provision of IP. 6 out of 20 subjects were accrued, 5 of which completed study. Due to early termination with few patients, only the counts of events have been calculated and no testing was done.",1.0,,Novartis has chosen to withdraw support for this trial,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,OTHER,,,,,,,2022,0.0
NCT02951117,,2016-10-28,,,2017-06-01,2016-10-28,2016-11-01,ESTIMATED,,,,,,,2017-06-01,2017-06-05,ACTUAL,2017-08-31,ESTIMATED,2017-08-31,2017-06,2017-06-30,2021-04-28,ESTIMATED,2021-04-28,2020-07-28,ESTIMATED,2020-07-28,,INTERVENTIONAL,,,A Study of Venetoclax and ABBV-838 Combination Therapy With Dexamethasone in Participants With Multiple Myeloma Whose Cancer Has Come Back or Had No Response to Recent Cancer Treatment,"A Phase 1b, Open Label, Multicenter, Dose Escalation Study of Venetoclax and ABBV-838 Combination Therapy With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma",WITHDRAWN,,PHASE1,0.0,ACTUAL,AbbVie,,2.0,,No participants enrolled,f,,,,f,t,f,,,,,,,,,,,2024-10-15 17:14:23.228277,2024-10-15 17:14:23.228277,INDUSTRY,,,,,,,2021,0.0
NCT03023904,,2017-01-10,,,2018-04-23,2017-01-13,2017-01-18,ESTIMATED,,,,,,,2018-04-23,2018-04-25,ACTUAL,2017-12-29,ACTUAL,2017-12-29,2018-04,2018-04-30,2020-07-30,ESTIMATED,2020-07-30,2019-07-30,ESTIMATED,2019-07-30,,INTERVENTIONAL,,,Nivolumab in Treating Patients With Stage IV or Recurrent Lung Cancer With High Mutation Loads,Nivolumab in Treating Patients With Stage IV or Recurrent Lung Cancer With High Mutation Loads,WITHDRAWN,,PHASE2,0.0,ACTUAL,Vanderbilt-Ingram Cancer Center,,1.0,,Research cancelled,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,OTHER,,,,,,,2020,0.0
NCT04582344,,2020-10-01,,,2024-05-23,2020-10-08,2020-10-09,ACTUAL,,,,,,,2024-05-23,2024-05-24,ACTUAL,2020-09-14,ACTUAL,2020-09-14,2022-08,2022-08-31,2022-07-27,ACTUAL,2022-07-27,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,,Clinical Trial For SARS-CoV-2 Vaccine (COVID-19),"Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial For Evaluation of Efficacy and Safety of SARS-CoV-2 Vaccine (Vero Cell), Inactivated",COMPLETED,,PHASE3,10214.0,ACTUAL,Health Institutes of Turkey,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,OTHER_GOV,,,,,,,2022,1.0
NCT04467515,,2020-06-10,,,2024-05-13,2020-07-07,2020-07-13,ACTUAL,,,,,,,2024-05-13,2024-05-16,ACTUAL,2021-09-14,ACTUAL,2021-09-14,2024-05,2024-05-31,2023-12-11,ACTUAL,2023-12-11,2023-12-11,ACTUAL,2023-12-11,,INTERVENTIONAL,,,"A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer","A Multi-Center Open Label Dose Escalation and Dose Expansion Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and GEJ Cancer",TERMINATED,,PHASE1/PHASE2,13.0,ACTUAL,Precirix,,1.0,,Per Strategic Sponsor decision,,,,,,t,f,,,,,,,,,,,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,INDUSTRY,,,,,,,2023,0.0
NCT03254394,,2017-08-09,2021-09-15,,2022-02-10,2017-08-15,2017-08-18,ACTUAL,2022-02-10,2022-03-09,ACTUAL,,,,2022-02-10,2022-03-09,ACTUAL,2017-09-15,ACTUAL,2017-09-15,2022-02,2022-02-28,2021-04-01,ACTUAL,2021-04-01,2020-09-28,ACTUAL,2020-09-28,,INTERVENTIONAL,,This includes only patients who are enrolled and randomized into 2 groups.,Lidocaine for Oxaliplatin-induced Neuropathy,Intravenous Lidocaine for Preventing Painful Oxaliplatin-induced Peripheral Neuropathy (OIPN),COMPLETED,,PHASE1/PHASE2,26.0,ACTUAL,Washington University School of Medicine,"Due to the COVID-19 pandemic, the study finished earlier than planned. The total number of patients enrolled was 26 instead of 30.",2.0,,,f,,,,t,t,f,,,f,,,6 months after publication,"IPD will be shared 6 months after publication of the results in a peer-reviewed journal, upon submission of a robust data analysis plan to the study investigators.",,YES,"IPD will be shared 6 months after publication of the results in a peer-reviewed journal, upon submission of a robust data analysis plan to the study investigators.",2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,OTHER,,,,,,,2021,1.0
NCT04162366,,2019-11-11,,,2022-11-22,2019-11-11,2019-11-14,ACTUAL,,,,,,,2022-11-22,2022-11-23,ACTUAL,2020-01,ESTIMATED,2020-01-31,2022-11,2022-11-30,2021-07-15,ESTIMATED,2021-07-15,2021-06-30,ESTIMATED,2021-06-30,,INTERVENTIONAL,INSPIRE-CKD,,A Research Study to Show Aprocitentan is Efficacious and Safe to Treat Patients With Uncontrolled Blood Pressure and Chronic Kidney Disease.,"Multi-center, Blinded, Randomized Study With Aprocitentan in Subjects With Uncontrolled Blood Pressure and Chronic Kidney Disease Stage 3 or 4.",WITHDRAWN,,PHASE3,0.0,ACTUAL,Idorsia Pharmaceuticals Ltd.,,3.0,,A business decision was made to not initiate this study,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,INDUSTRY,,,,,,,2021,0.0
NCT05218408,,2022-01-18,,,2023-02-15,2022-01-30,2022-02-01,ACTUAL,,,,,,,2023-02-15,2023-02-16,ACTUAL,2022-03-08,ACTUAL,2022-03-08,2023-02,2023-02-28,2024-05,ESTIMATED,2024-05-31,2024-02,ESTIMATED,2024-02-29,,INTERVENTIONAL,CYNK001GBM02,,CYNK-001 IV and IC in Combination With IL2 in Surgical Eligible Recurrent GBM With IDH-1 Wild Type,"A Phase I/IIa Open Label Multicenter, Non-Randomized, Trial to Assess the Safety and Efficacy of CYNK-001in Combination With Recombinant Human Interleukin-2 in Adults With Recurrent Resection Eligible IDH1 Wild-type Glioblastoma",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Celularity Incorporated,,2.0,,No enrolled subjects,f,,,,t,t,f,,,,,,,,,,,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,INDUSTRY,,,,,,,2024,0.0
NCT03395353,,2018-01-04,2021-05-03,,2021-05-25,2018-01-04,2018-01-10,ACTUAL,2021-05-25,2021-06-18,ACTUAL,,,,2021-05-25,2021-06-18,ACTUAL,2018-01-29,ACTUAL,2018-01-29,2021-05,2021-05-31,2020-07-04,ACTUAL,2020-07-04,2020-07-04,ACTUAL,2020-07-04,,INTERVENTIONAL,,All enrolled participants who received at least one dose of study drug. One participant received no dose of study drug and was not included in the analysis.,A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder,A Long-term Safety Study of Duloxetine Hydrochloride in the Treatment of Japanese Children and Adolescents With Depressive Disorder,TERMINATED,,PHASE3,151.0,ACTUAL,Shionogi Inc.,,1.0,,Business decision,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,INDUSTRY,,,,,,,2020,0.0
NCT03505099,,2018-04-13,2021-12-14,,2022-08-12,2018-04-13,2018-04-23,ACTUAL,2021-12-14,2022-01-11,ACTUAL,,,,2022-08-12,2022-09-07,ACTUAL,2018-04-02,ACTUAL,2018-04-02,2022-08,2022-08-31,2021-06-15,ACTUAL,2021-06-15,2021-06-15,ACTUAL,2021-06-15,,INTERVENTIONAL,SPR1NT,,Pre-Symptomatic Study of Intravenous Onasemnogene Abeparvovec-xioi in Spinal Muscular Atrophy (SMA) for Patients With Multiple Copies of SMN2,"A Global Study of a Single, One-Time Dose of AVXS-101 Delivered to Infants With Genetically Diagnosed and Pre-symptomatic Spinal Muscular Atrophy With Multiple Copies of SMN2",COMPLETED,,PHASE3,30.0,ACTUAL,Novartis,Link to the full study results: https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17902,1.0,,,f,,,,t,t,f,,,,,,,,https://www.clinicalstudydatarequest.com/,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.",2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,INDUSTRY,,,,,,,2021,1.0
NCT02460484,,2015-04-23,,,2022-03-16,2015-05-29,2015-06-02,ESTIMATED,,,,,,,2022-03-16,2022-03-18,ACTUAL,2015-04,,2015-04-30,2022-03,2022-03-31,2022-06,ESTIMATED,2022-06-30,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,Safety of Autologous Human Umbilical Cord Blood Treatment for Perinatal Arterial Ischemic Stroke,Safety of Autologous Human Umbilical Cord Blood Treatment for Perinatal,SUSPENDED,,PHASE1/PHASE2,10.0,ESTIMATED,AdventHealth,,1.0,,Restructuring Cell Lab,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,OTHER,,,,,,,2022,0.0
NCT02454205,,2015-05-22,,,2021-09-28,2015-05-26,2015-05-27,ESTIMATED,,,,,,,2021-09-28,2021-09-29,ACTUAL,2015-11-12,ACTUAL,2015-11-12,2021-09,2021-09-30,2021-08-30,ACTUAL,2021-08-30,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,NEXT,,An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis,Evaluating a New Treatment Regimen for Patients With Multidrug-resistant TB (MDR-TB) - a Prospective Open-label Randomised Controlled Trial,COMPLETED,,PHASE2/PHASE3,154.0,ACTUAL,University of Cape Town,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,OTHER,,,,,,,2021,1.0
NCT03635112,,2018-07-31,2022-12-30,,2023-02-14,2018-08-14,2018-08-17,ACTUAL,2023-02-14,2023-03-13,ACTUAL,,,,2023-02-14,2023-03-13,ACTUAL,2018-11-19,ACTUAL,2018-11-19,2023-02,2023-02-28,2021-12-30,ACTUAL,2021-12-30,2021-12-30,ACTUAL,2021-12-30,,INTERVENTIONAL,DIONE,Intent-to-Treat Analysis Set: Comprised all randomized participants who received at least one dose of study drug.,Efficacy and Safety of TD-1473 in Crohn's Disease,"A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo˗Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy With 2 Doses of TD-1473 in Subjects With Moderately-to-Severely Active Crohn's Disease",TERMINATED,,PHASE2,167.0,ACTUAL,Theravance Biopharma,The study was terminated by the sponsor on 16 November 2021 after a planned review by the Independent Data Monitoring Committee.,3.0,,The study was terminated by the sponsor on 16 November 2021 after a planned review by the Independent Data Monitoring Committee.,f,,,,t,t,f,,,,,,,,,NO,"Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.",2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,INDUSTRY,,,,,,,2021,0.0
NCT06026358,,2023-08-30,,,2024-05-29,2023-09-06,2023-09-07,ACTUAL,,,,,,,2024-05-29,2024-05-30,ACTUAL,2023-10,ESTIMATED,2023-10-31,2024-05,2024-05-31,2024-12,ESTIMATED,2024-12-31,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands,"Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands. An Internally Placebo Controlled, Partly Blinded Clinical Pilot Study",WITHDRAWN,,PHASE4,0.0,ACTUAL,Medical University of Graz,,2.0,,lack of ressources,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,OTHER,,,,,,,2024,0.0
NCT05104905,,2021-10-22,,,2022-05-05,2021-10-22,2021-11-03,ACTUAL,,,,,,,2022-05-05,2022-05-11,ACTUAL,2021-10-07,ACTUAL,2021-10-07,2022-05,2022-05-31,2022-01-28,ACTUAL,2022-01-28,2022-01-28,ACTUAL,2022-01-28,,INTERVENTIONAL,RENACOL,,"A Phase I/II Open Label Single Centre Trial to Assess the Safety, Tolerability and Efficacy of Single Dose Neoadjuvant Anti-CLEVER-1 Antibody Bexmarilimab in Localised Renal Cell and Colon Carcinoma","A Phase I/II Open Label Single Centre Trial to Assess the Safety, Tolerability and Efficacy of Single Dose Neoadjuvant Anti-CLEVER-1 Antibody Bexmarilimab in Localised Renal Cell and Colon Carcinoma (Macrophage Antibody To Inhibit Immune Suppression in RENAl Cell and COLon Carcinomas)",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Faron Pharmaceuticals Ltd,,8.0,,"Since no patients have been enrolled in RENACOL, and safety and tolerability data is rapidly accumulating in another ongoing study, sponsor considered that RENACOL study is no longer needed to assess the safety profile of bexmarilimab",f,,,,t,f,f,,,f,,,,,,,,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,INDUSTRY,,,,,,,2022,0.0
NCT03710564,,2018-10-16,2022-06-28,2021-10-12,2023-01-27,2018-10-16,2018-10-18,ACTUAL,2022-06-28,2022-07-22,ACTUAL,2021-10-12,2021-10-15,ACTUAL,2023-01-27,2023-01-30,ACTUAL,2018-10-30,ACTUAL,2018-10-30,2023-01,2023-01-31,2021-07-01,ACTUAL,2021-07-01,2020-12-21,ACTUAL,2020-12-21,,INTERVENTIONAL,MERLIN,,Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections,"A Multicenter, Randomized, Double-masked Phase 3a Study to Assess Safety and Efficacy of Brolucizumab 6 mg q4 Weeks Compared to Aflibercept 2 mg q4 Weeks in Patients With Neovascular Age-related Macular Degeneration (nAMD) With Persistent Retinal Fluid (MERLIN)",TERMINATED,,PHASE3,535.0,ACTUAL,Novartis,,2.0,,Sponsor Decision,f,,,,f,t,f,,,,,,,,https://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,INDUSTRY,,,,,,,2021,0.0
NCT05304663,,2022-02-24,,,2024-04-05,2022-03-30,2022-03-31,ACTUAL,,,,,,,2024-04-05,2024-04-08,ACTUAL,2022-06-01,ESTIMATED,2022-06-01,2024-04,2024-04-30,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,GLIOASTRA,,Safety and Efficacy of Different Administration Sequences of L19TNF With Lomustine in Glioblastoma at First Progression,A Study to Evaluate the Safety and Efficacy of Different Administration Sequences of L19TNF in Combination With Lomustine in Patients With Glioblastoma at First Progression,WITHDRAWN,,PHASE1,0.0,ACTUAL,Philogen S.p.A.,,2.0,,The Sponsor had no further plan for the study in object,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,INDUSTRY,,,,,,,2024,0.0
NCT05000450,,2021-08-04,,,2024-06-27,2021-08-04,2021-08-11,ACTUAL,,,,,,,2024-06-27,2024-06-28,ACTUAL,2021-06-06,ACTUAL,2021-06-06,2024-06,2024-06-30,2023-10-11,ACTUAL,2023-10-11,2023-10-11,ACTUAL,2023-10-11,,INTERVENTIONAL,,,Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma,"A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-647 and ALLO-605, an Anti- BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma",TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,Allogene Therapeutics,,1.0,,Terminated (Halted Prematurely),f,,,,,t,f,,,,,,,,,,,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,INDUSTRY,,,,,,,2023,0.0
NCT04310579,,2020-03-09,2022-10-12,,2024-05-14,2020-03-12,2020-03-17,ACTUAL,2024-05-14,2024-05-21,ACTUAL,,,,2024-05-14,2024-05-21,ACTUAL,2020-06-15,ACTUAL,2020-06-15,2023-11,2023-11-30,2021-05-25,ACTUAL,2021-05-25,2021-05-25,ACTUAL,2021-05-25,,INTERVENTIONAL,,,Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation,Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation,COMPLETED,,PHASE1,55.0,ACTUAL,Food and Drug Administration (FDA),,3.0,,,f,,,,f,t,f,,,f,,,,,,YES,"Plan is to make data from the study publicly available as part of a manuscript publication. In addition, the protocol and statistical analysis plan will be made available online at this site as well as any eventual publications.",2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,FED,,,,,,,2021,1.0
NCT02355535,,2015-01-30,,,2020-09-22,2015-02-03,2015-02-04,ESTIMATED,,,,,,,2020-09-22,2020-09-24,ACTUAL,2015-02,ACTUAL,2015-02-28,2020-09,2020-09-30,2020-05-18,ACTUAL,2020-05-18,2020-05-18,ACTUAL,2020-05-18,,INTERVENTIONAL,,,Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1,(STM-03) Phase I Study of Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1,COMPLETED,,PHASE1,48.0,ACTUAL,"Vanquish Oncology, Inc.",,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,INDUSTRY,,,,,,,2020,1.0
NCT03489265,,2018-03-09,,,2019-07-23,2018-04-03,2018-04-05,ACTUAL,,,,,,,2019-07-23,2019-07-25,ACTUAL,2019-04,ESTIMATED,2019-04-30,2019-07,2019-07-31,2020-03,ESTIMATED,2020-03-31,2019-09,ESTIMATED,2019-09-30,,INTERVENTIONAL,ELXDFI,,Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence,Treatment of Diarrhea-Associated Fecal Incontinence With Eluxadoline,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,Difficult to recruit severely affected patients with fecal incontinence,f,,,,t,t,f,,,f,,,9-36 months following publication of the study results.,"Requester must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IED), or Research Ethics Board (REB), and requester has executed an acceptable data use/sharing agreement with UNC.",https://irbis2.research.unc.edu/irb/,YES,"Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and executes a data use/sharing agreement with the University of North Carolina.",2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,OTHER,,,,,,,2020,0.0
NCT03437746,,2018-02-13,,,2022-09-13,2018-02-13,2018-02-19,ACTUAL,,,,,,,2022-09-13,2022-09-15,ACTUAL,2018-03-01,ACTUAL,2018-03-01,2022-09,2022-09-30,2021-11-24,ACTUAL,2021-11-24,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,CORTICOLON,,Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study,Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study,TERMINATED,,PHASE2,78.0,ACTUAL,Centre Hospitalier Universitaire Dijon,,,,insufficient rate of inclusion,f,,,,,f,f,,,,,,,,,,,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,OTHER,,,,,,,2021,0.0
NCT05159128,,2021-12-06,,,2022-02-04,2021-12-06,2021-12-15,ACTUAL,,,,,,,2022-02-04,2022-02-22,ACTUAL,2021-11-15,ACTUAL,2021-11-15,2022-02,2022-02-28,2022-04-02,ESTIMATED,2022-04-02,2022-04-02,ESTIMATED,2022-04-02,,INTERVENTIONAL,,,A Study of JNJ-75105186 in Healthy Japanese and Chinese Participants,"A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-75105186 in Healthy Japanese Participants and a Single Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-75105186 in Healthy Chinese Participants",WITHDRAWN,,PHASE1,0.0,ACTUAL,Janssen Pharmaceutical K.K.,,2.0,,Business Decision,f,,,,f,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,INDUSTRY,,,,,,,2022,0.0
NCT02049866,,2014-01-28,2021-03-30,,2022-11-15,2014-01-28,2014-01-30,ESTIMATED,2021-03-30,2021-04-21,ACTUAL,,,,2022-11-15,2022-12-12,ACTUAL,2014-11-19,ACTUAL,2014-11-19,2022-10,2022-10-31,2021-12-23,ACTUAL,2021-12-23,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,,Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP,Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With Idiopathic Osteoporosis (IOP),COMPLETED,,PHASE2,33.0,ACTUAL,Columbia University,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,OTHER,,,,,,,2021,1.0
NCT05451017,,2022-06-27,,,2024-07-11,2022-07-07,2022-07-11,ACTUAL,,,,,,,2024-07-11,2024-07-12,ACTUAL,2023-01-04,ACTUAL,2023-01-04,2024-07,2024-07-31,2023-06-28,ACTUAL,2023-06-28,2023-06-26,ACTUAL,2023-06-26,,INTERVENTIONAL,,,The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers,The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers,TERMINATED,,PHASE1,24.0,ACTUAL,Aelis Farma,,2.0,,"Study was initially paused due to a research hold of the institution. However, the study will not continue as the sample size of patients collected prior to the pause allowed for adequate data analysis of the study endpoints.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,INDUSTRY,,,,,,,2023,0.0
NCT03720990,,2018-10-24,2023-09-30,,2024-04-26,2018-10-24,2018-10-26,ACTUAL,2023-11-21,2023-12-13,ACTUAL,,,,2024-04-26,2024-04-30,ACTUAL,2021-03-27,ACTUAL,2021-03-27,2024-04,2024-04-30,2023-09-30,ACTUAL,2023-09-30,2022-08-30,ACTUAL,2022-08-30,,INTERVENTIONAL,,12,Smith-Lemli-Opitz Syndrome and Cholic Acid,Smith-Lemli-Opitz Syndrome: A Pilot Study of Cholic Acid Supplementation,COMPLETED,,PHASE1/PHASE2,12.0,ACTUAL,University of Nebraska,No limitations or caveats.,1.0,,,f,,,,t,t,f,,,t,,,Data will be available one year after completion of the study. Data will be available indefinitely.,Data will be made available to everyone.,,YES,"All data will be de-identified and submitted to the Database of Genotypes and Phenotypes (dbGAP), according to NIH regulations.",2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,OTHER,,,,,plasma,,2023,1.0
NCT03621761,,2018-08-03,2022-10-03,,2022-12-05,2018-08-03,2018-08-08,ACTUAL,2022-12-05,2022-12-27,ACTUAL,,,,2022-12-05,2022-12-27,ACTUAL,2018-11-15,ACTUAL,2018-11-15,2022-12,2022-12-31,2021-11-30,ACTUAL,2021-11-30,2021-08-24,ACTUAL,2021-08-24,,INTERVENTIONAL,COMBO-MS,,"Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue","A Randomized Controlled Trial of Telephone-delivered Cognitive Behavioral-therapy, Modafinil, and Combination Therapy of Both Interventions for Fatigue in Multiple Sclerosis",COMPLETED,,PHASE4,343.0,ACTUAL,University of Michigan,,3.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,OTHER,,,,,,,2021,1.0
NCT05163756,,2021-12-07,,,2021-12-07,2021-12-07,2021-12-20,ACTUAL,,,,,,,2021-12-07,2021-12-20,ACTUAL,2020-11-25,ACTUAL,2020-11-25,2021-12,2021-12-31,2021-05-10,ACTUAL,2021-05-10,2021-04-27,ACTUAL,2021-04-27,,INTERVENTIONAL,,,To Evaluate the Efficacy and Safety of DW1903 in Acute and Chronic Gastritis Patient,"A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1903 in Patients With Gastritis",COMPLETED,,PHASE3,332.0,ACTUAL,"Daewon Pharmaceutical Co., Ltd.",,2.0,,,f,,,,,f,f,,,,,,,,,NO,There is no plan for IPD.,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,INDUSTRY,,,,,,,2021,1.0
NCT05289830,,2022-03-11,,,2024-06-17,2022-03-11,2022-03-21,ACTUAL,,,,,,,2024-06-17,2024-06-18,ACTUAL,2022-08-05,ACTUAL,2022-08-05,2024-06,2024-06-30,2023-08-27,ACTUAL,2023-08-27,2023-08-27,ACTUAL,2023-08-27,,INTERVENTIONAL,,,Escitalopram to Placebo in Patients With Localized Pancreatic Cancer,"A Phase II, Randomized, Double-blind, Trial Comparing Escitalopram to Placebo in Patients With Localized Pancreatic Cancer",TERMINATED,,PHASE2,4.0,ACTUAL,Case Comprehensive Cancer Center,,2.0,,Slow accrual,f,,,,t,t,f,,,f,,,4 years to publication,,,YES,plan to publish the results,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,OTHER,,,,,,,2023,0.0
NCT02743611,,2016-04-11,2023-06-08,,2023-09-12,2016-04-18,2016-04-19,ESTIMATED,2023-09-12,2023-10-05,ACTUAL,,,,2023-09-12,2023-10-05,ACTUAL,2017-04-14,ACTUAL,2017-04-14,2023-06,2023-06-30,2020-07-19,ACTUAL,2020-07-19,2019-07-19,ACTUAL,2019-07-19,,INTERVENTIONAL,,,Safety & Activity of Controllable PRAME-TCR Therapy in Previously Treated AML/MDS or Metastatic Uveal Melanoma,"A Phase 1/2 Dose-Finding Study to Evaluate the Safety, Feasibility, and Activity of BPX-701, a Controllable PRAME T-Cell Receptor Therapy, in HLA-A2+ Subjects With AML, Previously Treated MDS, or Metastatic Uveal Melanoma",TERMINATED,,PHASE1/PHASE2,4.0,ACTUAL,Bellicum Pharmaceuticals,,4.0,,company decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,INDUSTRY,,,,,,,2020,0.0
NCT03635567,,2018-08-15,2023-09-20,,2024-06-12,2018-08-15,2018-08-17,ACTUAL,2023-09-20,2023-10-12,ACTUAL,,,,2024-06-12,2024-06-25,ACTUAL,2018-10-25,ACTUAL,2018-10-25,2024-06,2024-06-30,2024-06-04,ACTUAL,2024-06-04,2022-10-03,ACTUAL,2022-10-03,,INTERVENTIONAL,,,"Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)",COMPLETED,,PHASE3,617.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 17:20:59.799345,2024-10-15 17:20:59.799345,INDUSTRY,,,,,,,2024,1.0
NCT04411446,,2020-05-26,,,2021-07-28,2020-05-31,2020-06-02,ACTUAL,,,,,,,2021-07-28,2021-07-30,ACTUAL,2020-08-11,ACTUAL,2020-08-11,2021-03,2021-03-31,2021-07-28,ACTUAL,2021-07-28,2021-07-28,ACTUAL,2021-07-28,,INTERVENTIONAL,CARED,,Cholecalciferol to Improve the Outcomes of COVID-19 Patients,Randomized Controlled Trial of High Dose of Vitamin D as Compared With Placebo to Prevent Complications Among COVID-19 Patients,COMPLETED,,PHASE4,218.0,ACTUAL,Vitamin D Study Group,,2.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 17:27:29.412593,2024-10-15 17:27:29.412593,NETWORK,,,,,,,2021,0.0
NCT04304534,,2020-03-08,2023-02-19,,2023-04-03,2020-03-08,2020-03-11,ACTUAL,2023-04-03,2023-04-05,ACTUAL,,,,2023-04-03,2023-04-05,ACTUAL,2020-06-17,ACTUAL,2020-06-17,2023-04,2023-04-30,2022-02-21,ACTUAL,2022-02-21,2022-02-21,ACTUAL,2022-02-21,,INTERVENTIONAL,PACIFIC-AMI,FAS(Full data analysis),Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack,"Multicenter, Randomized, Placebo Controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate the Efficacy and Safety of BAY 2433334 in Patients Following an Acute Myocardial Infarction",COMPLETED,,PHASE2,1601.0,ACTUAL,Bayer,,4.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,"Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-15 17:27:29.412593,2024-10-15 17:27:29.412593,INDUSTRY,,,,,,,2022,1.0
NCT02962895,,2016-11-03,,2020-07-16,2022-01-20,2016-11-09,2016-11-15,ESTIMATED,,,,,,,2022-01-20,2022-01-24,ACTUAL,2017-06-27,ACTUAL,2017-06-27,2022-01,2022-01-31,2021-09-23,ACTUAL,2021-09-23,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS),Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS),COMPLETED,,PHASE2,192.0,ACTUAL,Novartis,,4.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 18:03:23.937454,2024-10-15 18:03:23.937454,INDUSTRY,,,,,,,2021,1.0
NCT02918968,,2016-09-27,2021-03-25,,2021-05-18,2016-09-27,2016-09-29,ESTIMATED,2021-05-18,2021-05-21,ACTUAL,,,,2021-05-18,2021-05-21,ACTUAL,2016-11-02,ACTUAL,2016-11-02,2021-05,2021-05-31,2020-03-27,ACTUAL,2020-03-27,2020-03-27,ACTUAL,2020-03-27,,INTERVENTIONAL,,Intent-to-Treat (ITT) population was defined as all participants randomized in this study.,Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer,A Randomized Phase IV Study Comparing Enzalutamide Versus Flutamide in Castration-resistant Prostate Cancer (CRPC) Patients Who Have Failed Combined Androgen Blockade Therapy With Bicalutamide Plus Androgen Deprivation Therapy (ADT),COMPLETED,,PHASE4,206.0,ACTUAL,Astellas Pharma Inc,,2.0,,,f,,,,f,t,f,,,t,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://www.clinicalstudydatarequest.com/,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-15 17:27:29.412593,2024-10-15 17:27:29.412593,INDUSTRY,,,,,,,2020,1.0
NCT02175212,,2014-06-23,2016-05-04,,2020-11-03,2014-06-25,2014-06-26,ESTIMATED,2016-09-16,2016-11-04,ESTIMATED,,,,2020-11-03,2020-11-20,ACTUAL,2005-11,,2005-11-30,2020-11,2020-11-30,2020-09-24,ACTUAL,2020-09-24,2014-06,ACTUAL,2014-06-30,,INTERVENTIONAL,AADLPC,,Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer,Phase III Multicenter Randomized Trial of Adjuvant Androgen Deprivation in Combination With Three-dimensional Conformal Radiotherapy Doses in High and Intermediate Risk Localized Prostate Cancer.,COMPLETED,,PHASE3,362.0,ACTUAL,Fundación de Investigación Biomédica - Hospital Universitario de La Princesa,* Relatively short follow-up and low number of events.~* The lack of patient-reported outcomes.~* Our decision to include vascular events other than strictly cardiac events (e.g. the presence of CVA or thromboembolic disease).,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 17:27:29.412593,2024-10-15 17:27:29.412593,OTHER,,,,,,,2020,1.0
NCT05054400,,2021-09-03,,,2023-08-30,2021-09-21,2021-09-23,ACTUAL,,,,,,,2023-08-30,2023-09-01,ACTUAL,2020-02-05,ACTUAL,2020-02-05,2023-08,2023-08-31,2023-08-29,ACTUAL,2023-08-29,2023-08-29,ACTUAL,2023-08-29,,INTERVENTIONAL,,,Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR,Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,0 participant accrual,f,,,,f,t,f,,,,,,,,,,,2024-10-15 17:27:29.412593,2024-10-15 17:27:29.412593,OTHER,,,,,,,2023,0.0
NCT05165849,,2021-12-06,,,2022-05-16,2021-12-16,2021-12-21,ACTUAL,,,,,,,2022-05-16,2022-05-20,ACTUAL,2022-04,ESTIMATED,2022-04-30,2022-05,2022-05-31,2022-05-11,ACTUAL,2022-05-11,2022-05-11,ACTUAL,2022-05-11,,INTERVENTIONAL,,,A Study of GFS101A in Combination With Toripalimab in Patients With Advanced Solid Tumors,"A Multicenter, Open-label, Phase I/Ⅱ Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFS101A in Combination With Toripalimab Treating Patients With Advanced Solid Tumors",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Genfleet Therapeutics (Shanghai) Inc.,,1.0,,sponsor decided to withdraw the study,f,,,,,f,f,,,,,,,,,,,2024-10-15 17:27:29.412593,2024-10-15 17:27:29.412593,INDUSTRY,,,,,,,2022,0.0
NCT03393117,,2017-12-26,,,2020-07-21,2018-01-05,2018-01-08,ACTUAL,,,,,,,2020-07-21,2020-07-22,ACTUAL,2018-03-30,ACTUAL,2018-03-30,2020-07,2020-07-31,2020-07-01,ESTIMATED,2020-07-01,2020-07-01,ESTIMATED,2020-07-01,,INTERVENTIONAL,,,Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction,"Prospective, Randomized, Blinded Comparison of Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Unilateral, Immediate Breast Reconstruction",WITHDRAWN,,PHASE2,0.0,ACTUAL,Case Comprehensive Cancer Center,,2.0,,No accrual,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 17:27:29.412593,2024-10-15 17:27:29.412593,OTHER,,,,,,,2020,0.0
NCT03994146,,2019-06-13,,,2023-08-18,2019-06-20,2019-06-21,ACTUAL,,,,,,,2023-08-18,2023-08-22,ACTUAL,2020-01-16,ACTUAL,2020-01-16,2023-08,2023-08-31,2023-08-18,ACTUAL,2023-08-18,2023-08-18,ACTUAL,2023-08-18,,INTERVENTIONAL,,,Remifentanil Tapering and Post-adenotonsillectomy Pain in Children,"Remifentanil Tapering and Post-adenotonsillectomy Pain in Children: a Randomised, Placebo Controlled, Double Blind Study",TERMINATED,,PHASE4,6.0,ACTUAL,"University Hospital, Akershus",,2.0,,Recruitment rate was not compatible with study completion,f,,,,t,f,f,,,f,,,The data will be available following completion of the study and analysis and publication by the investigating team.~There is no plan to time limit access to the data following this.,On request and following consultation with the Regional Ethics Committee and the Data Protection Officer at the host institution.,,YES,On request and following consultation with the Regional Ethics Committee and the Data Protection Officer at the host institution.,2024-10-15 17:27:29.412593,2024-10-15 17:27:29.412593,OTHER,,,,,,,2023,0.0
NCT03987451,,2019-06-12,2024-04-10,2022-04-19,2024-05-28,2019-06-12,2019-06-17,ACTUAL,2024-05-28,2024-05-29,ACTUAL,,2024-05-29,ACTUAL,2024-05-28,2024-05-29,ACTUAL,2019-06-18,ACTUAL,2019-06-18,2024-05,2024-05-31,2021-06-10,ACTUAL,2021-06-10,2021-04-22,ACTUAL,2021-04-22,,INTERVENTIONAL,,Full analysis set (FAS) included all randomized participants.,A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage,Investigation of Efficacy and Safety of Semaglutide s.c. Once-weekly Versus Placebo in Subjects With Non-alcoholic Steatohepatitis and Compensated Liver Cirrhosis,COMPLETED,,PHASE2,71.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 17:27:29.412593,2024-10-15 17:27:29.412593,INDUSTRY,,,,,,,2021,1.0
NCT02987543,,2016-11-15,2020-06-03,,2023-10-04,2016-12-06,2016-12-09,ESTIMATED,2020-09-18,2020-10-12,ACTUAL,,,,2023-10-04,2023-10-06,ACTUAL,2017-02-06,ACTUAL,2017-02-06,2023-09,2023-09-30,2023-02-15,ACTUAL,2023-02-15,2019-06-04,ACTUAL,2019-06-04,,INTERVENTIONAL,,,Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study),"A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound)",COMPLETED,,PHASE3,387.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 17:27:29.412593,2024-10-15 17:27:29.412593,INDUSTRY,,,,,,,2023,1.0
NCT03061474,,2017-02-13,2023-08-22,,2023-09-22,2017-02-17,2017-02-23,ACTUAL,2023-09-22,2023-10-17,ACTUAL,,,,2023-09-22,2023-10-17,ACTUAL,2017-07-12,ACTUAL,2017-07-12,2023-09,2023-09-30,2022-08-30,ACTUAL,2022-08-30,2022-08-30,ACTUAL,2022-08-30,,INTERVENTIONAL,NEAT,,Nicotinamide as an Early Alzheimer's Disease Treatment,"A Double-Blind-Randomized, Placebo-Controlled Adaptive Design Trial of Nicotinamide in Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease Dementia",COMPLETED,,PHASE2,46.0,ACTUAL,"University of California, Irvine",,2.0,,,,,,,t,t,f,,,,,,6 months after publication,"Data requestors must complete ADCS data and sample sharing request form. Upon approval, requestors must complete a data use agreement prior to accessing data.",https://www.adcs.org/data-sharing,YES,"Data sharing is integral to the ADCS's mission to develop and execute innovative clinical trials focused on interventions that may prevent, delay, or treat the expression of Alzheimer's disease and related dementias. The ADCS is committed to sharing resources and tools, including data, biospecimens, trial designs, outcome and analysis measures following NIH guidelines.~DATA Sharing: The ADCS Data and Sample Sharing Committee (DSSC) grants access to de-identified data to individuals who complete the request process and agree to the conditions in an ADCS/UCSD Data Us Agreement (DUA). After approval and receipt of the fully executed DUA, applicants are authorized to acquire data. Non-compliance with the DUA, including the requirement to provide requested updates will jeopardize further access to data.",2024-10-15 17:27:29.412593,2024-10-15 17:27:29.412593,OTHER,,,,,,,2022,1.0
NCT03121963,,2017-04-17,,,2021-06-17,2017-04-17,2017-04-20,ACTUAL,,,,,,,2021-06-17,2021-06-22,ACTUAL,2017-11-10,ACTUAL,2017-11-10,2021-06,2021-06-30,2021-11-06,ESTIMATED,2021-11-06,2020-11-06,ACTUAL,2020-11-06,,INTERVENTIONAL,,,Pain Management in Head and Neck Surgery Patients,Pain Management in Head and Neck Surgery Patients,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Alabama at Birmingham,,2.0,,"This protocol was difficult to enroll into, and changes to personnel have made it difficult to main this study. Data collection was not completed and therefore, no data analysis was performed. The PI has made the decision to close this study.",f,,,,f,t,f,,,f,,,,,,NO,There is no current plan to share individual participant data for this protocol.,2024-10-15 17:27:29.412593,2024-10-15 17:27:29.412593,OTHER,,,,,,,2021,0.0
NCT03038399,,2017-01-30,2021-04-28,,2021-04-28,2017-01-30,2017-01-31,ESTIMATED,2021-04-28,2021-05-20,ACTUAL,,,,2021-04-28,2021-05-20,ACTUAL,2017-02-02,ACTUAL,2017-02-02,2021-04,2021-04-30,2020-04-30,ACTUAL,2020-04-30,2020-04-30,ACTUAL,2020-04-30,,INTERVENTIONAL,,"Subjects entered this study in one of 4 dose level groups, but were allowed to escalate/de-escalate during the course of the study.",Long-term Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD),"A 24-month Phase II Open-label, Multicenter Long-term Extension Study to Assess the Long-Term Safety and Efficacy of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)",COMPLETED,,PHASE2,46.0,ACTUAL,"ReveraGen BioPharma, Inc.",,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 17:27:29.412593,2024-10-15 17:27:29.412593,INDUSTRY,,,,,,,2020,1.0
NCT03639324,,2018-08-08,,,2021-11-01,2018-08-16,2018-08-21,ACTUAL,,,,,,,2021-11-01,2021-11-09,ACTUAL,2020-10-02,ACTUAL,2020-10-02,2021-11,2021-11-30,2021-10-18,ACTUAL,2021-10-18,2021-10-18,ACTUAL,2021-10-18,,INTERVENTIONAL,RIVe-CLL/SLL,,"Rituximab, Idelalisib, and Venetoclax in Relapsed/Refractory CLL/SLL","Phase 1 Trial of Rituximab, Idelalisib, and Venetoclax in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (RIVe-CLL/SLL)",WITHDRAWN,,PHASE1,0.0,ACTUAL,Virginia Commonwealth University,,6.0,,Slow Accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:27:29.412593,2024-10-15 17:27:29.412593,OTHER,,,,,,,2021,0.0
NCT04484935,,2020-06-30,2023-08-29,,2023-10-25,2020-07-20,2020-07-24,ACTUAL,2023-10-25,2023-11-15,ACTUAL,,,,2023-10-25,2023-11-15,ACTUAL,2020-08-19,ACTUAL,2020-08-19,2023-10,2023-10-31,2023-02-17,ACTUAL,2023-02-17,2023-02-17,ACTUAL,2023-02-17,,INTERVENTIONAL,MUSIC,The As-treated population consisted of all participants who were enrolled and received any dose of nirsevimab.,"Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children","A Phase 2, Open-label, Uncontrolled, Single-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Occurrence of Antidrug Antibody for Nirsevimab in Immunocompromised Children ≤ 24 Months of Age",COMPLETED,,PHASE2,100.0,ACTUAL,AstraZeneca,,1.0,,,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AstraZeneca (AZ) disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AstraZeneca (AZ) are accepting requests for Individual Participant Data (IPD), but this does not mean all requests will be shared.",2024-10-15 18:03:23.937454,2024-10-15 18:03:23.937454,INDUSTRY,,,,,,,2023,1.0
NCT04746131,,2021-02-04,,,2022-09-22,2021-02-04,2021-02-09,ACTUAL,,,,,,,2022-09-22,2022-09-26,ACTUAL,2021-01-15,ACTUAL,2021-01-15,2022-04,2022-04-30,2024-04-11,ESTIMATED,2024-04-11,2024-04-11,ESTIMATED,2024-04-11,,INTERVENTIONAL,,,Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL),Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL),SUSPENDED,,PHASE1,90.0,ESTIMATED,ImmuneOnco Biopharmaceuticals (Shanghai) Inc.,,1.0,,"Due to the product development strategy change, without any safety concerns, we (the sponsor of the trial) have decided to request to place the IND (#151570) on inactive status.",f,,,,,t,f,,,,,,,,,,,2024-10-15 18:03:23.937454,2024-10-15 18:03:23.937454,OTHER,,,,,,,2024,0.0
NCT03068468,,2017-02-27,2020-09-03,,2020-11-25,2017-02-27,2017-03-01,ACTUAL,2020-11-25,2020-12-21,ACTUAL,,,,2020-11-25,2020-12-21,ACTUAL,2017-06-01,ACTUAL,2017-06-01,2020-11,2020-11-30,2020-02-07,ACTUAL,2020-02-07,2019-09-06,ACTUAL,2019-09-06,,INTERVENTIONAL,PASSPORT,Intent-to-treat (ITT) population included randomized participants who had received at least 1 dose of blinded study treatment (BIIB092 or Placebo).,Study of BIIB092 in Participants With Progressive Supranuclear Palsy,"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants With Progressive Supranuclear Palsy",TERMINATED,,PHASE2,490.0,ACTUAL,Biogen,Study got terminated as the primary endpoint was not met. PC period was completed at the time of termination. The study was not terminated due to a safety concern.,2.0,,251PP301(PASSPORT) primary endpoint was not met;Biogen decision to close the study early. There were no safety concerns with the PASSPORT study.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 17:33:07.36542,2024-10-15 17:33:07.36542,INDUSTRY,,,,,,,2020,0.0
NCT04731051,,2021-01-28,,,2023-04-05,2021-01-28,2021-01-29,ACTUAL,,,,,,,2023-04-05,2023-04-07,ACTUAL,2022-10,ESTIMATED,2022-10-31,2023-04,2023-04-30,2022-12,ESTIMATED,2022-12-31,2022-11,ESTIMATED,2022-11-30,,INTERVENTIONAL,,,The Potential Use of Inhaled Hydroxychloroquine for the Treatment of COVID-19 in Cancer Patients,"A Pilot, Randomized, Open-label Trial to Determine the Feasibility, Safety, Efficacy, and Pharmacokinetics of Nebulized HCQ01 for the Treatment of Patients With COVID-19 and Cancer",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,King Hussein Cancer Center,,2.0,,the study was terminated as no more COVID cases were treated at the center,f,,,,f,f,f,,,,,,,,,,,2024-10-15 17:33:07.36542,2024-10-15 17:33:07.36542,OTHER,,,,,,,2022,0.0
NCT04658849,,2020-10-27,,,2023-05-11,2020-12-07,2020-12-09,ACTUAL,,,,,,,2023-05-11,2023-05-15,ACTUAL,2020-12-02,ACTUAL,2020-12-02,2023-05,2023-05-31,2023-03-29,ACTUAL,2023-03-29,2023-03-29,ACTUAL,2023-03-29,,INTERVENTIONAL,,,Insulin Resistance Following ADT for Prostate CA,Insulin Resistance Following Androgen Deprivation Therapy in Men With Prostate Cancer,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,St. Louis University,,2.0,,End of grant funding,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 17:33:07.36542,2024-10-15 17:33:07.36542,OTHER,,,,,,,2023,0.0
NCT05629364,,2022-11-17,,,2024-01-09,2022-11-17,2022-11-29,ACTUAL,,,,,,,2024-01-09,2024-01-10,ACTUAL,2023-03-15,ACTUAL,2023-03-15,2024-01,2024-01-31,2024-01-09,ACTUAL,2024-01-09,2024-01-09,ACTUAL,2024-01-09,,INTERVENTIONAL,,,"A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune Disease","A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune Disease",TERMINATED,,PHASE2,4.0,ACTUAL,"Kiora Pharmaceuticals, Inc.",,3.0,,Study halted prematurely but potentially will resume,f,,,,f,f,f,,,,,,,,,,,2024-10-15 17:33:07.36542,2024-10-15 17:33:07.36542,INDUSTRY,,,,,,,2024,0.0
NCT04246619,,2020-01-24,,,2022-03-29,2020-01-28,2020-01-29,ACTUAL,,,,,,,2022-03-29,2022-04-07,ACTUAL,2019-11-12,ACTUAL,2019-11-12,2022-03,2022-03-31,2021-12-21,ACTUAL,2021-12-21,2021-12-21,ACTUAL,2021-12-21,,INTERVENTIONAL,BLOSSOM,,"Efficacy of Pregabalin and Duloxetine in Patients With PDPN: the Effect of Pain on Cognitive Function, Sleep and Quality of Life","Efficacy of Pregabalin and Duloxetine in Patients With Painful Diabetic Peripheral Neuropathy (PDPN): the Effect of Pain on Cognitive Function, Sleep and Quality of Life (BLOSSOM)",TERMINATED,,PHASE4,254.0,ACTUAL,KRKA,,2.0,,The statistical analysis will still provide relevant results with the same statistical power as initially planned.COVID-19 pandemic prolonged the recruiting period and consequently affected the costs of the clinical trial.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 17:33:07.36542,2024-10-15 17:33:07.36542,INDUSTRY,,,,,,,2021,0.0
NCT00995150,,2009-10-13,2023-10-31,2022-08-04,2024-07-22,2009-10-14,2009-10-15,ESTIMATED,2024-07-22,2024-08-14,ACTUAL,2022-08-04,2022-08-09,ACTUAL,2024-07-22,2024-08-14,ACTUAL,2009-11,ACTUAL,2009-11-30,2024-07,2024-07-31,2021-10-12,ACTUAL,2021-10-12,2021-10-12,ACTUAL,2021-10-12,,INTERVENTIONAL,,,"A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception","A Phase 3, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception",TERMINATED,,PHASE3,1910.0,ACTUAL,Medicines360,,3.0,,The data cutoff date of 05 April 2021 was chosen as it coincides with all subjects completing through Year 8 of use (intended duration of use for the product).,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:33:07.36542,2024-10-15 17:33:07.36542,OTHER,,,,,,,2021,0.0
NCT04347135,,2020-04-13,,,2024-05-08,2020-04-13,2020-04-15,ACTUAL,,,,,,,2024-05-08,2024-05-10,ACTUAL,2022-10-07,ACTUAL,2022-10-07,2024-04,2024-04-30,2024-04-30,ACTUAL,2024-04-30,2024-04-30,ACTUAL,2024-04-30,,INTERVENTIONAL,,,Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI,Pilot Study Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Mayo Clinic,,1.0,,No Enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 17:33:07.36542,2024-10-15 17:33:07.36542,OTHER,,,,,,,2024,0.0
NCT03795428,,2018-12-18,,,2022-02-04,2019-01-04,2019-01-07,ACTUAL,,,,,,,2022-02-04,2022-02-22,ACTUAL,2019-04-10,ACTUAL,2019-04-10,2022-02,2022-02-28,2022-01-11,ACTUAL,2022-01-11,2022-01-11,ACTUAL,2022-01-11,,INTERVENTIONAL,VIP Extend,,"Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) in PAH Subjects Following Completion of Study PB1046-PT-CL-0004","A Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) Subcutaneous Injections in Pulmonary Arterial Hypertension Subjects Following Completion of Study PB1046-PT-CL-0004",TERMINATED,,PHASE2,25.0,ACTUAL,PhaseBio Pharmaceuticals Inc.,,1.0,,Terminated: Study drug resupply delayed (Covid-19),f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:33:07.36542,2024-10-15 17:33:07.36542,INDUSTRY,,,,,,,2022,0.0
NCT05193318,,2021-12-14,2024-03-13,,2024-04-10,2021-12-30,2022-01-14,ACTUAL,2024-04-10,2024-05-06,ACTUAL,,,,2024-04-10,2024-05-06,ACTUAL,2022-01-13,ACTUAL,2022-01-13,2024-04,2024-04-30,2023-03-20,ACTUAL,2023-03-20,2023-03-20,ACTUAL,2023-03-20,,INTERVENTIONAL,KReDO,,KAP for Depression in Abstinent Opioid Users,Ketamine-assisted Psychotherapy for the Treatment of Persistent Depression in Abstinent Opioid Users,TERMINATED,,PHASE2,5.0,ACTUAL,Medical University of South Carolina,,1.0,,Primary Investigator leaving institution,f,,,,f,t,f,,,,,,,,,,,2024-10-15 17:33:07.36542,2024-10-15 17:33:07.36542,OTHER,,,,,,,2023,0.0
NCT03052361,,2017-02-07,,,2020-10-19,2017-02-09,2017-02-14,ACTUAL,,,,,,,2020-10-19,2020-10-22,ACTUAL,2017-07-15,ACTUAL,2017-07-15,2020-10,2020-10-31,2020-10-03,ACTUAL,2020-10-03,2020-09-03,ACTUAL,2020-09-03,,INTERVENTIONAL,,,Triage Administration of Ondansetron for Gastroenteritis in Children,Triage Administration of Ondansetron for Gastroenteritis in Children; a Randomized Controlled Trial,TERMINATED,,PHASE2/PHASE3,81.0,ACTUAL,St. Justine's Hospital,,2.0,,The recruitment was much slower than expected and the COVID pandemic added new barriers to recruitment.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 17:33:07.36542,2024-10-15 17:33:07.36542,OTHER,,,,,,,2020,0.0
NCT05136443,,2021-10-29,2024-07-23,,2024-07-23,2021-11-17,2021-11-29,ACTUAL,2024-07-23,2024-08-14,ACTUAL,,,,2024-07-23,2024-08-14,ACTUAL,2021-11-23,ACTUAL,2021-11-23,2023-09,2023-09-30,2023-09-05,ACTUAL,2023-09-05,2023-09-05,ACTUAL,2023-09-05,,INTERVENTIONAL,,,Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection,Prospective Analysis of Loteprednol Etabonate Ophthalmic Suspension 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty,COMPLETED,,PHASE4,70.0,ACTUAL,Price Vision Group,,1.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 17:33:07.36542,2024-10-15 17:33:07.36542,INDUSTRY,,,,,,,2023,1.0
NCT03398837,,2018-01-05,,,2021-03-25,2018-01-11,2018-01-16,ACTUAL,,,,,,,2021-03-25,2021-03-29,ACTUAL,2017-12-18,ACTUAL,2017-12-18,2021-03,2021-03-31,2020-12-21,ACTUAL,2020-12-21,2020-05-27,ACTUAL,2020-05-27,,INTERVENTIONAL,RESOLVE-1,,Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis",TERMINATED,,PHASE3,365.0,ACTUAL,Corbus Pharmaceuticals Inc.,,3.0,,Sponsor terminated open-label extension,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 17:33:07.36542,2024-10-15 17:33:07.36542,INDUSTRY,,,,,,,2020,0.0
NCT02002819,,2013-10-25,2021-10-04,,2022-04-22,2013-12-02,2013-12-06,ESTIMATED,2022-04-22,2022-05-16,ACTUAL,,,,2022-04-22,2022-05-16,ACTUAL,2014-10-16,ACTUAL,2014-10-16,2022-04,2022-04-30,2020-07-21,ACTUAL,2020-07-21,2020-07-21,ACTUAL,2020-07-21,,INTERVENTIONAL,LEV-AD,,Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability,Phase 2a Levetiracetam Trial for AD-Associated Network Hyperexcitability,COMPLETED,,PHASE2,34.0,ACTUAL,University of Minnesota,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 17:33:07.36542,2024-10-15 17:33:07.36542,OTHER,,,,,,,2020,1.0
NCT04572217,,2020-09-25,,,2022-05-19,2020-09-25,2020-10-01,ACTUAL,,,,,,,2022-05-19,2022-05-26,ACTUAL,2022-06,ESTIMATED,2022-06-30,2022-05,2022-05-31,2022-06,ESTIMATED,2022-06-30,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,MAABS Protocol,,Medications After Adolescent Bariatric Surgery,Medications After Adolescent Bariatric Surgery Protocol for Inadequate Weight Loss Following Sleeve Gastrectomy in Adolescents and Young Adults: A Pilot Feasibility Study,WITHDRAWN,,PHASE2,0.0,ACTUAL,Stanford University,,2.0,,No available funding,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 17:33:07.36542,2024-10-15 17:33:07.36542,OTHER,,,,,,,2022,0.0
NCT04361253,,2020-04-23,,,2021-08-09,2020-04-23,2020-04-24,ACTUAL,,,,,,,2021-08-09,2021-08-13,ACTUAL,2020-04-30,ACTUAL,2020-04-30,2021-08,2021-08-31,2021-06-30,ACTUAL,2021-06-30,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,(ESCAPE),,Evaluation of SARS-CoV-2 (COVID-19) Antibody-containing Plasma thErapy,"A Prospective, Randomized, Double-Masked, Placebo-Controlled Trial of High-Titer COVID-19 Convalescent Plasma (HT-CCP) for the Treatment of Hospitalized Patients With COVID-19 of Moderate Severity",TERMINATED,,PHASE3,45.0,ACTUAL,Brigham and Women's Hospital,,2.0,,Futility,f,,,,,t,f,,,f,,,Beginning 3 months after study publication. No end date.,Proposals should be submitted to rmkaufman@bwh.harvard.edu.,,YES,Deidentified data will be made available upon request to the principal investigator following the publication of the primary manuscript.,2024-10-15 17:33:07.36542,2024-10-15 17:33:07.36542,OTHER,,,,,,,2021,0.0
NCT04990219,,2021-07-29,,,2023-02-01,2021-07-29,2021-08-04,ACTUAL,,,,,,,2023-02-01,2023-02-03,ACTUAL,2021-09-27,ACTUAL,2021-09-27,2023-01,2023-01-31,2023-01-31,ACTUAL,2023-01-31,2023-01-19,ACTUAL,2023-01-19,,INTERVENTIONAL,,,A Study of Lu AG06466 for the Treatment of Spasticity in Participants With Multiple Sclerosis,"Interventional, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 1B Study Investigating the Effects of Lu AG06466 for the Treatment of Spasticity in Patients With Multiple Sclerosis",TERMINATED,,PHASE1,37.0,ACTUAL,H. Lundbeck A/S,,2.0,,The study was terminated for strategic reasons,f,,,,f,t,f,,,,,,,,,,,2024-10-15 17:33:07.36542,2024-10-15 17:33:07.36542,INDUSTRY,,,,,,,2023,0.0
NCT00487305,,2007-06-15,,,2024-08-13,2007-06-15,2007-06-18,ESTIMATED,,,,,,,2024-08-13,2024-08-15,ACTUAL,2007-06,ACTUAL,2007-06-30,2024-08,2024-08-31,2023-07-25,ACTUAL,2023-07-25,2023-07-25,ACTUAL,2023-07-25,,INTERVENTIONAL,,,Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma,A Phase I Trial of Vaccination With Lethally Irradiated Lymphoma Cells Admixed With Granulocyte-Macrophage Colony Stimulating Factor Secreting K562 Cells for the Treatment of Previously Untreated or Relapses Follicular Lymphoma,COMPLETED,,PHASE1,24.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,OTHER,,,,,,,2023,0.0
NCT02403323,,2015-03-26,,,2023-10-30,2015-03-26,2015-03-31,ESTIMATED,,,,,,,2023-10-30,2023-11-01,ACTUAL,2015-06-08,ACTUAL,2015-06-08,2023-10,2023-10-31,2023-10-09,ACTUAL,2023-10-09,2023-10-09,ACTUAL,2023-10-09,,INTERVENTIONAL,JUNIPER,,Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144,An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144,TERMINATED,,PHASE3,900.0,ESTIMATED,Hoffmann-La Roche,,2.0,,"The study was terminated due to program discontinuation, based on mixed efficacy results in the parent studies. There were no safety concerns.",f,,,,,,,,,,,,,,,,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,INDUSTRY,,,,,,,2023,0.0
NCT05664100,,2022-12-13,,,2023-04-25,2022-12-21,2022-12-23,ACTUAL,,,,,,,2023-04-25,2023-04-27,ACTUAL,2022-12-15,ACTUAL,2022-12-15,2023-04,2023-04-30,2023-04-12,ACTUAL,2023-04-12,2023-04-12,ACTUAL,2023-04-12,,INTERVENTIONAL,,,First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss,"A Phase 1b, Prospective, Randomized, Single-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety of FX-345 Administered as a Single Intratympanic Injection in Adults With Acquired Adult-Onset Sensorineural Hearing Loss",TERMINATED,,PHASE1,6.0,ACTUAL,Frequency Therapeutics,,4.0,,Business reasons,f,,,,f,t,f,,,,,,,,,,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,INDUSTRY,,,,,,,2023,0.0
NCT04465734,,2020-07-07,,,2022-05-01,2020-07-09,2020-07-10,ACTUAL,,,,,,,2022-05-01,2022-05-05,ACTUAL,2022-11-15,ESTIMATED,2022-11-15,2021-07,2021-07-31,2024-03-15,ESTIMATED,2024-03-15,2023-10-15,ESTIMATED,2023-10-15,,INTERVENTIONAL,,,A Clinical Study to Compare the Efficacy and Safety of HLX10 in Combination With HLX04 Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic HCC,"A Randomized, Open-Label, Controlled, Multicenter, Phase III Clinical Study to Compare the Efficacy and Safety of HLX10 (Anti-PD-1 Antibody) in Combination With HLX04 (Anti-VEGF Antibody) Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC)",WITHDRAWN,,PHASE3,0.0,ACTUAL,Shanghai Henlius Biotech,,2.0,,The trial used sorafenib as a control drug. It's not suitable now(after the A+T has been approved).The sponsor terminated the trial.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,INDUSTRY,,,,,,,2024,0.0
NCT03478956,,2018-03-26,2020-05-19,,2023-11-01,2018-03-26,2018-03-27,ACTUAL,2020-07-21,2020-08-05,ACTUAL,,,,2023-11-01,2023-12-01,ACTUAL,2018-03-27,ACTUAL,2018-03-27,2023-11,2023-11-30,2023-09-27,ACTUAL,2023-09-27,2019-12-02,ACTUAL,2019-12-02,,INTERVENTIONAL,FENNEL,,A Phase I Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease,"A Phase I, Open-Label, Randomized, Pharmacokinetic, Pharmacodynamic, And Safety Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients From 4 Years To Less Than 18 Years Of Age With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease",TERMINATED,,PHASE1,24.0,ACTUAL,Hoffmann-La Roche,,2.0,,"The study was terminated due to program discontinuation, based on mixed efficacy results in the adult ulcerative colitis and Crohn's disease studies. There were no safety concerns.",f,,,,f,t,f,,,,,,,,,,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,INDUSTRY,,,,,,,2023,0.0
NCT03743246,,2018-10-18,2024-07-22,,2024-07-22,2018-11-13,2018-11-16,ACTUAL,2024-07-22,2024-08-15,ACTUAL,,,,2024-07-22,2024-08-15,ACTUAL,2018-10-17,ACTUAL,2018-10-17,2024-07,2024-07-31,2024-01-26,ACTUAL,2024-01-26,2024-01-26,ACTUAL,2024-01-26,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL),"A Phase 1/2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL).",TERMINATED,,PHASE1/PHASE2,21.0,ACTUAL,Celgene,The study was terminated and hence participants were not enrolled in Phase 2 cohorts (r/r B-ALL; MRD+ B-ALL; r/r B-NHL).,1.0,,Absence of significant therapeutic benefit over existing therapies,f,,,,t,t,f,,,,,,,,,,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,INDUSTRY,,,,,,,2024,0.0
NCT03749590,,2018-11-12,,,2021-04-28,2018-11-20,2018-11-21,ACTUAL,,,,,,,2021-04-28,2021-05-03,ACTUAL,2012-08-27,ACTUAL,2012-08-27,2021-04,2021-04-30,2020-08-31,ACTUAL,2020-08-31,2020-07,ACTUAL,2020-07-31,,INTERVENTIONAL,MagPEP,,Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.,Prospective Randomized Controlled Phase III Trial to Investigate the Efficacy of Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.,TERMINATED,,PHASE3,327.0,ACTUAL,University Medicine Greifswald,,2.0,,The design of the MagPEP trial is no longer in compliance with the current state of science.,f,,,,,f,f,,,,,,,,,,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,OTHER,,,,,,,2020,0.0
NCT03417492,,2017-10-11,,,2022-09-16,2018-01-24,2018-01-31,ACTUAL,,,,,,,2022-09-16,2022-09-21,ACTUAL,2018-03-01,ACTUAL,2018-03-01,2022-09,2022-09-30,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,,Cerebrovascular Reactivity in American Football Players,Cerebrovascular Reactivity Assessed With Functional Near-infrared Spectroscopy and Magnetic Resonance Imaging as a Biomarker of Traumatic Microvascular Injury in American Football Players,TERMINATED,,PHASE1,7.0,ACTUAL,University of Pennsylvania,,1.0,,"Difficulty enrolling participants due to COVID emergency, and planned start of new study to address this question in a more rigorous fashion.",f,,,,f,t,f,,,f,,,,,,,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,OTHER,,,,,,,2022,0.0
NCT03582618,,2018-05-21,,,2023-01-06,2018-07-09,2018-07-11,ACTUAL,,,,,,,2023-01-06,2023-01-10,ACTUAL,2018-07-12,ACTUAL,2018-07-12,2023-01,2023-01-31,2022-12-30,ACTUAL,2022-12-30,2021-11-16,ACTUAL,2021-11-16,,INTERVENTIONAL,,,CVM-1118 and Sorafenib Combination in Subjects With Advanced Hepatocellular Carcinoma,"A Phase 2, Open-Label Study With Orally Administered CVM-1118 and Sorafenib in Subjects With Advanced Hepatocellular Carcinoma",TERMINATED,,PHASE2,12.0,ACTUAL,"TaiRx, Inc.",,1.0,,The study has been terminated due to slow enrollment,f,,,,f,t,f,,,,,,,,,,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,INDUSTRY,,,,,,,2022,0.0
NCT02263508,,2014-09-26,2022-03-08,,2022-11-10,2014-10-09,2014-10-13,ESTIMATED,2022-04-22,2022-05-16,ACTUAL,,,,2022-11-10,2022-11-14,ACTUAL,2014-12-08,ACTUAL,2014-12-08,2022-11,2022-11-30,2021-03-11,ACTUAL,2021-03-11,2021-03-11,ACTUAL,2021-03-11,,INTERVENTIONAL,MASTERKEY-265,All enrolled participants,Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma,"A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265)",TERMINATED,,PHASE3,713.0,ACTUAL,Amgen,,3.0,,,f,,,,t,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,INDUSTRY,,,,,,,2021,0.0
NCT03011645,,2017-01-04,,,2020-02-13,2017-01-04,2017-01-05,ESTIMATED,,,,,,,2020-02-13,2020-02-17,ACTUAL,2018-05-24,ACTUAL,2018-05-24,2020-02,2020-02-29,2020-01-28,ACTUAL,2020-01-28,2020-01-28,ACTUAL,2020-01-28,,INTERVENTIONAL,,,Gene-by-Stress Interactions in Intervention Studies Significance,Gene-by-Stress Interactions in Intervention Studies Significance,TERMINATED,,PHASE1,7.0,ACTUAL,Duke University,,3.0,,Lack of participants,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,OTHER,,,,,,,2020,0.0
NCT03663166,,2018-09-06,2022-10-21,,2023-02-14,2018-09-06,2018-09-10,ACTUAL,2023-02-14,2023-02-15,ACTUAL,,,,2023-02-14,2023-02-15,ACTUAL,2018-11-20,ACTUAL,2018-11-20,2023-02,2023-02-28,2021-10-22,ACTUAL,2021-10-22,2021-10-22,ACTUAL,2021-10-22,,INTERVENTIONAL,,,Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC),Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable NSCLC,TERMINATED,,PHASE1/PHASE2,19.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,2.0,,Increased SAE occurrence per PI,,,,,t,t,f,,,,,,,,,,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,OTHER,,,,,,,2021,0.0
NCT04201743,,2019-12-08,,,2020-09-30,2019-12-14,2019-12-17,ACTUAL,,,,,,,2020-09-30,2020-10-05,ACTUAL,2020-03-30,ACTUAL,2020-03-30,2020-09,2020-09-30,2021-12,ESTIMATED,2021-12-31,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee,"A Prospective, Double-Blinded, Randomized Controlled Trial of an Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee",WITHDRAWN,,PHASE4,0.0,ACTUAL,Illinois Center for Orthopaedic Research and Education,,2.0,,Resources limited secondary to COVID-19 pandemic.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,OTHER,,,,,,,2021,0.0
NCT04426695,,2020-06-08,2022-05-05,,2023-01-25,2020-06-10,2020-06-11,ACTUAL,2022-06-28,2022-07-25,ACTUAL,,,,2023-01-25,2023-01-27,ACTUAL,2020-06-10,ACTUAL,2020-06-10,2023-01,2023-01-31,2021-10-22,ACTUAL,2021-10-22,2021-05-07,ACTUAL,2021-05-07,,INTERVENTIONAL,,The full analysis set (FAS) included all randomized participants who received at least one dose (full or partial) of the study drug.,"Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19","A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients With COVID-19",COMPLETED,,PHASE1/PHASE2,2252.0,ACTUAL,Regeneron Pharmaceuticals,,4.0,,,f,,,,t,t,f,,,,,,"Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification","Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).",https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,INDUSTRY,,,,,,,2021,1.0
NCT05845359,,2022-10-26,,,2023-10-16,2023-04-25,2023-05-06,ACTUAL,,,,,,,2023-10-16,2023-10-18,ACTUAL,2023-09,ESTIMATED,2023-09-30,2023-10,2023-10-31,2024-02,ESTIMATED,2024-02-29,2024-02,ESTIMATED,2024-02-29,,INTERVENTIONAL,,,Intraoperative Methadone for Postoperative Pain Control,Randomized Control Study on the Effectiveness of Intraoperative Methadone on Postoperative Pain Control,WITHDRAWN,,PHASE4,0.0,ACTUAL,Montefiore Medical Center,,2.0,,IRB approval never received,f,,,,,t,f,,,t,,,,,,NO,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,OTHER,,,,,,,2024,0.0
NCT03983395,,2019-05-31,,,2021-05-19,2019-06-07,2019-06-12,ACTUAL,,,,,,,2021-05-19,2021-05-24,ACTUAL,2020-04-08,ACTUAL,2020-04-08,2021-05,2021-05-31,2020-07-24,ACTUAL,2020-07-24,2020-07-24,ACTUAL,2020-07-24,,INTERVENTIONAL,,,Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer,"A Phase 1/2, Open-Label, Dose-Escalation Study of ISB 1302 in Subjects With HER2-Positive Metastatic Breast Cancer",TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,Ichnos Sciences SA,,8.0,,"The study was terminated during Part 1 (dose escalation), and Part 2 (expansion) of the study was not initiated. This study was voluntarily terminated due to a business decision not to proceed with the ISB 1302 asset, and not due to any safety issue.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,INDUSTRY,,,,,,,2020,0.0
NCT03049449,,2017-02-09,2022-04-28,,2022-12-21,2017-02-09,2017-02-10,ACTUAL,2022-04-28,2022-05-25,ACTUAL,,,,2022-12-21,2023-01-18,ACTUAL,2017-03-17,ACTUAL,2017-03-17,2022-12,2022-12-31,2022-01-26,ACTUAL,2022-01-26,2022-01-26,ACTUAL,2022-01-26,,INTERVENTIONAL,,"2 participants who had baseline data collected and were enrolled but not treated, is reported here.",T Cells Expressing a Fully-Human Anti-CD30 Chimeric Antigen Receptor for Treating CD30-Expressing Lymphomas,Anti-CD30 CAR T Cells With Fully-human Binding Domains for Treating CD30-expressing Lymphomas Including Anaplastic Large Cell Lymphomas,COMPLETED,,PHASE1,26.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,,f,,,,f,t,f,,,,,,Data will be shared before publication. And at the time of publication or shortly thereafter.,"An National Institutes of Health (NIH)-funded or approved public repository - Clinical Trials.gov, Biomedical Translational Research Information System (BTRIS), and publication and/or presentations.",,YES,"We will share coded, linked data in an National Institutes of Health (NIH)-funded or approved public repository. Coded, linked data in Biomedical Translational Research Information System (BTRIS).",2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,NIH,,,,,,,2022,0.0
NCT04466904,,2020-07-01,,,2021-07-21,2020-07-07,2020-07-10,ACTUAL,,,,,,,2021-07-21,2021-07-23,ACTUAL,2020-09-12,ACTUAL,2020-09-12,2021-07,2021-07-31,2021-05-28,ACTUAL,2021-05-28,2021-05-28,ACTUAL,2021-05-28,,INTERVENTIONAL,,,Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM,A Multiple Dose Human Tolerability and Pharmacokinetic Study of IBI362 in Chinese Patients With Type 2 Diabetes Mellitus and Poor Glycemic Control,COMPLETED,,PHASE1/PHASE2,42.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,3.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,INDUSTRY,,,,,,,2021,1.0
NCT03700723,,2018-09-18,,,2021-01-06,2018-10-07,2018-10-09,ACTUAL,,,,,,,2021-01-06,2021-01-07,ACTUAL,2018-12-14,ACTUAL,2018-12-14,2021-01,2021-01-31,2020-04-15,ACTUAL,2020-04-15,2020-04-15,ACTUAL,2020-04-15,,INTERVENTIONAL,,,Comparison of the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy,"Multicenter, Single-Blinded, Randomized, Comparator-Controlled Noninferiority Trial to Compare the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy",TERMINATED,,PHASE2,4.0,ACTUAL,"Entegrion, Inc.",,2.0,,Convenience of Government Funding Sponsor,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,INDUSTRY,,,,,,,2020,0.0
NCT03273153,,2017-09-01,2020-04-14,,2022-08-24,2017-09-01,2017-09-06,ACTUAL,2020-05-27,2020-06-09,ACTUAL,,,,2022-08-24,2022-09-21,ACTUAL,2017-12-11,ACTUAL,2017-12-11,2022-08,2022-08-31,2021-02-19,ACTUAL,2021-02-19,2019-04-15,ACTUAL,2019-04-15,,INTERVENTIONAL,,,A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma,"A Phase III, Open-Label, Multicenter, Two Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma",TERMINATED,,PHASE3,446.0,ACTUAL,Hoffmann-La Roche,,2.0,,This study was terminated due to benefit/risk analysis.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,INDUSTRY,,,,,,,2021,0.0
NCT03185819,,2017-06-12,2024-03-24,,2024-03-24,2017-06-12,2017-06-14,ACTUAL,2024-03-24,2024-04-17,ACTUAL,,,,2024-03-24,2024-04-17,ACTUAL,2017-10-05,ACTUAL,2017-10-05,2024-03,2024-03-31,2023-03-31,ACTUAL,2023-03-31,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,,All baseline characteristics were analyzed on the safety analysis set which included all randomized participants who received at least one dose of DB study drug.,"Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide","A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Subjects Assessed to be at Imminent Risk for Suicide",COMPLETED,,PHASE2,147.0,ACTUAL,"Janssen Research & Development, LLC",,4.0,,,t,,,,t,t,f,,,,,,,,,,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,INDUSTRY,,NCT03829579,APPROVED_FOR_MARKETING,,,,2023,1.0
NCT03394027,,2018-01-05,2021-12-17,,2022-07-28,2018-01-06,2018-01-09,ACTUAL,2021-12-17,2022-01-12,ACTUAL,,,,2022-07-28,2022-08-23,ACTUAL,2018-01-17,ACTUAL,2018-01-17,2022-07,2022-07-31,2021-10-07,ACTUAL,2021-10-07,2021-03-18,ACTUAL,2021-03-18,,INTERVENTIONAL,,,ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma,A Phase 2 Study of ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma,COMPLETED,,PHASE2,30.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,,f,,,,f,t,f,,,,,,Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.,,YES,"All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to database of Genotypes and Phenotypes (dbGaP).",2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,NIH,,,,,,,2021,0.0
NCT03121586,,2017-04-13,,,2024-08-13,2017-04-17,2017-04-20,ACTUAL,,,,,,,2024-08-13,2024-08-15,ACTUAL,2017-01,ACTUAL,2017-01-31,2024-08,2024-08-31,2024-06,ACTUAL,2024-06-30,2024-06,ACTUAL,2024-06-30,,INTERVENTIONAL,,,Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia,"A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia",TERMINATED,,PHASE3,996.0,ACTUAL,ACADIA Pharmaceuticals Inc.,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,INDUSTRY,,,,,,,2024,0.0
NCT03008915,,2016-12-22,2020-11-30,2019-07-30,2021-01-28,2016-12-30,2017-01-04,ESTIMATED,2021-01-28,2021-02-17,ACTUAL,2020-01-30,2020-02-07,ACTUAL,2021-01-28,2021-02-17,ACTUAL,2017-01,ACTUAL,2017-01-31,2021-01,2021-01-31,2020-10,ACTUAL,2020-10-31,2018-07,ACTUAL,2018-07-31,,INTERVENTIONAL,,All participants,Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency,Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency,COMPLETED,,PHASE2,15.0,ACTUAL,Columbia University,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,OTHER,,,,,,,2020,1.0
NCT03097107,,2017-03-24,,,2023-02-03,2017-03-30,2017-03-31,ACTUAL,,,,,,,2023-02-03,2023-02-08,ACTUAL,2017-04-06,ACTUAL,2017-04-06,2023-02,2023-02-28,2024-01,ESTIMATED,2024-01-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Evaluate the Safety and Efficacy of Saroglitazar Mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL,"Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Arm, 12-week Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium 1, 2 and 4 mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL",SUSPENDED,,PHASE2,124.0,ESTIMATED,Zydus Therapeutics Inc.,,4.0,,Management decision to suspend the study due to recruitment issues,f,,,,t,t,f,,,,,,,,,NO,See above.,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,INDUSTRY,,,,,,,2024,0.0
NCT06216561,,2023-12-22,,,2024-08-16,2024-01-16,2024-01-22,ACTUAL,,,,,,,2024-08-16,2024-08-20,ACTUAL,2023-11-30,ACTUAL,2023-11-30,2024-08,2024-08-31,2024-06-24,ACTUAL,2024-06-24,2024-06-24,ACTUAL,2024-06-24,,INTERVENTIONAL,,,Intraperitoneal LSTA1 in CRS-HIPEC,A Phase I Trial of Intraperitoneal LSTA1 in Patients Undergoing Cytoreductive Surgery and HIPEC for Peritoneal Surface Malignancy,WITHDRAWN,,PHASE1,0.0,ACTUAL,"University of California, San Diego",,2.0,,closed early due to low (0) accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,OTHER,,,,,,,2024,0.0
NCT05901467,,2023-05-31,,,2024-05-31,2023-06-12,2023-06-13,ACTUAL,,,,,,,2024-05-31,2024-06-03,ACTUAL,2023-10-20,ACTUAL,2023-10-20,2024-05,2024-05-31,2024-05-29,ACTUAL,2024-05-29,2024-05-29,ACTUAL,2024-05-29,,INTERVENTIONAL,,,Recall by Genotype: Neuropeptide Stimulation,Recall by Genotype: Neuropeptide Stimulation,TERMINATED,,PHASE1,16.0,ACTUAL,Massachusetts General Hospital,,1.0,,The study team no longer has access to GnRH. The study has been altered to account for this change and is no longer a clinical trial.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,OTHER,,,,,,,2024,0.0
NCT05226533,,2022-02-04,,,2023-02-08,2022-02-04,2022-02-07,ACTUAL,,,,,,,2023-02-08,2023-02-10,ACTUAL,2022-03-31,ACTUAL,2022-03-31,2023-02,2023-02-28,2022-12-21,ACTUAL,2022-12-21,2022-12-16,ACTUAL,2022-12-16,,INTERVENTIONAL,,,Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.,"A Phase 2, Double Blind, Randomized, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of DWRX2003 in Combination With Remdesivir Following Intramuscular Administration in Moderate-Severe COVID-19 Patients",TERMINATED,,PHASE2,1.0,ACTUAL,Daewoong Pharmaceutical Co. LTD.,,3.0,,Study stopped due to difficulties in patient recruitment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,INDUSTRY,,,,,,,2022,0.0
NCT04437199,,2020-06-11,,,2024-02-07,2020-06-16,2020-06-18,ACTUAL,,,,,,,2024-02-07,2024-02-08,ACTUAL,2020-12-17,ACTUAL,2020-12-17,2024-02,2024-02-29,2022-02-07,ACTUAL,2022-02-07,2022-02-07,ACTUAL,2022-02-07,,INTERVENTIONAL,,,Tricaprilin Phase 2 Pilot Study in Migraine,"A 12-Week, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-SD-03 in Participants With Migraine",COMPLETED,,PHASE2,83.0,ACTUAL,Cerecin,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 15:54:15.550997,2024-10-16 15:54:15.550997,INDUSTRY,,,,,,,2022,1.0
NCT02028221,,2014-01-02,2021-02-17,2020-09-22,2023-06-02,2014-01-03,2014-01-07,ESTIMATED,2021-02-17,2021-03-12,ACTUAL,2020-09-28,2020-10-05,ACTUAL,2023-06-02,2023-06-27,ACTUAL,2014-03-07,ACTUAL,2014-03-07,2023-06,2023-06-30,2022-06-14,ACTUAL,2022-06-14,2018-11-30,ACTUAL,2018-11-30,,INTERVENTIONAL,,,Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk,Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk,COMPLETED,,PHASE2,151.0,ACTUAL,University of Arizona,,2.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 16:00:55.776746,2024-10-16 16:00:55.776746,OTHER,,,,,,,2022,1.0
NCT04270760,,2020-02-13,2023-08-01,2022-10-20,2023-08-24,2020-02-13,2020-02-17,ACTUAL,2023-08-01,2023-08-23,ACTUAL,2022-10-20,2022-10-24,ACTUAL,2023-08-24,2023-09-07,ACTUAL,2020-07-28,ACTUAL,2020-07-28,2023-08,2023-08-31,2022-11-08,ACTUAL,2022-11-08,2021-12-27,ACTUAL,2021-12-27,,INTERVENTIONAL,,Full Analysis Set (FAS): includes all randomized participants who received at least one dose of IP.,Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study,"A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Olpasiran (AMG 890) in Subjects With Elevated Lipoprotein(a)",COMPLETED,,PHASE2,281.0,ACTUAL,Amgen,,5.0,,,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,INDUSTRY,,,,,,,2022,1.0
NCT02685709,,2016-01-28,2021-09-29,,2022-03-24,2016-02-14,2016-02-19,ESTIMATED,2022-03-24,2022-04-22,ACTUAL,,,,2022-03-24,2022-04-22,ACTUAL,2016-02,ACTUAL,2016-02-29,2022-03,2022-03-31,2021-08,ACTUAL,2021-08-31,2020-10,ACTUAL,2020-10-31,,INTERVENTIONAL,MPOWERED,Acromegaly patients who previously tolerated and demonstrated a biochemical control on SRLs,Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly,"A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands",COMPLETED,,PHASE3,146.0,ACTUAL,"Chiasma, Inc.",,4.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,INDUSTRY,,,,,,,2021,1.0
NCT03488147,,2018-03-28,,,2020-11-20,2018-04-03,2018-04-04,ACTUAL,,,,,,,2020-11-20,2020-11-23,ACTUAL,2020-07,ESTIMATED,2020-07-31,2020-11,2020-11-30,2020-07-02,ACTUAL,2020-07-02,2020-07-02,ACTUAL,2020-07-02,,INTERVENTIONAL,,,"Whether Proton Pump Inhibitors, Administered Prior to or After Surgery, Can Reduce the Incidence and/or Severity of Difficulty Swallowing Foods and/or Liquids,Following Anterior Cervical Surgery","The Effect of Esomeprazole Magnesium on Incidence of Dysphagia Following Anterior Cervical Spine Surgery: A Prospective, Randomized, Double Blinded, Placebo-Controlled Study",WITHDRAWN,,PHASE2,0.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,3.0,,Change in Investigational Drug Service policies resulting in the need to change the operational design of the overall protocol.,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 16:00:55.776746,2024-10-16 16:00:55.776746,OTHER,,,,,,,2020,0.0
NCT02625974,,2015-12-07,2019-07-22,,2024-03-21,2015-12-07,2015-12-09,ESTIMATED,2019-10-10,2019-10-29,ACTUAL,,,,2024-03-21,2024-08-19,ACTUAL,2016-01-27,ACTUAL,2016-01-27,2024-03,2024-03-31,2021-08-10,ACTUAL,2021-08-10,2018-07-25,ACTUAL,2018-07-25,,INTERVENTIONAL,,,"A Study to Learn How Well Nifurtimox Works and How Safe it is in Children Aged 0 to 17 Years With Chagas' Disease, an Inflammatory, Infectious Disease Caused by the Parasite Trypanosoma Cruzi","Prospective, Historically Controlled Study to Evaluate the Efficacy and Safety of a New Pediatric Formulation of Nifurtimox in Children Aged 0 to 17 Years With Chagas' Disease",COMPLETED,,PHASE3,330.0,ACTUAL,Bayer,Abnormal findings on neurological examination by physical examination after Screening will be documented as AEs.,2.0,,,f,,,,t,,f,,,,,,,,,,,2024-10-16 16:00:55.776746,2024-10-16 16:00:55.776746,INDUSTRY,,,,,,,2021,1.0
NCT03615924,,2018-06-22,2021-02-05,,2021-03-15,2018-07-31,2018-08-06,ACTUAL,2021-03-15,2021-04-09,ACTUAL,,,,2021-03-15,2021-04-09,ACTUAL,2018-09-26,ACTUAL,2018-09-26,2021-03,2021-03-31,2020-08-13,ACTUAL,2020-08-13,2020-08-13,ACTUAL,2020-08-13,,INTERVENTIONAL,HESTIA3,The Full Analysis Set (FAS) included all randomized participants regardless of treatment received.,Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease,"A Randomised, Double-Blind, Parallel-Group, Multicentre, Phase III Study to Evaluate the Effect of Ticagrelor Versus Placebo in Reducing the Rate of Vaso-Occlusive Crises in Paediatric Patients With Sickle Cell Disease (HESTIA3)",TERMINATED,,PHASE3,193.0,ACTUAL,AstraZeneca,"AstraZeneca took the decision to terminate the study early, following a recommendation from the independent Data Monitoring Committee. This early termination was not considered to have had an impact on the robustness of the study results.",2.0,,Recommendation from an independent data monitoring committee (DMC) and accepted by AstraZeneca.,f,,,,t,t,f,,,f,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,INDUSTRY,,,,,,,2020,0.0
NCT02777580,,2016-05-13,2024-01-23,,2024-07-09,2016-05-17,2016-05-19,ESTIMATED,2024-07-09,2024-10-04,ACTUAL,,,,2024-07-09,2024-10-04,ACTUAL,2017-08-01,ACTUAL,2017-08-01,2024-07,2024-07-31,2023-09-30,ACTUAL,2023-09-30,2022-10-13,ACTUAL,2022-10-13,,INTERVENTIONAL,STREAM-2,,STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction,STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction,COMPLETED,,PHASE4,609.0,ACTUAL,KU Leuven,,2.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 16:00:55.776746,2024-10-16 16:00:55.776746,OTHER,,,,,,,2023,1.0
NCT04857138,,2021-04-22,,,2024-02-02,2021-04-22,2021-04-23,ACTUAL,,,,,,,2024-02-02,2024-02-05,ACTUAL,2021-05-18,ACTUAL,2021-05-18,2024-02,2024-02-29,2024-01-18,ACTUAL,2024-01-18,2024-01-18,ACTUAL,2024-01-18,,INTERVENTIONAL,,,"A Study to Evaluate Safety, Pharmacokinetics and Anti-Tumor Activity of RO7300490, as Single Agent or in Combination With Atezolizumab in Participants With Advanced Solid Tumors","An Open-Label, Multicenter, Dose-Escalation and Expansion, Phase I Study to Evaluate Safety, Pharmacokinetics, And Anti-Tumor Activity of RO7300490, A Fibroblast Activation Protein-α (FAP) Targeted CD40 Agonist, as Single Agent or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors",COMPLETED,,PHASE1,80.0,ACTUAL,Hoffmann-La Roche,,3.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 16:00:55.776746,2024-10-16 16:00:55.776746,INDUSTRY,,,,,,,2024,1.0
NCT02950558,,2016-10-04,2020-12-11,,2021-06-30,2016-10-27,2016-11-01,ESTIMATED,2021-06-30,2021-07-02,ACTUAL,,,,2021-06-30,2021-07-02,ACTUAL,2018-05-29,ACTUAL,2018-05-29,2021-06,2021-06-30,2020-06-19,ACTUAL,2020-06-19,2019-11-14,ACTUAL,2019-11-14,,INTERVENTIONAL,,,Anesthesia for Pain After Ankle Fracture Surgery,Pilot Study: Extended Regional Anesthesia to Prevent Chronic Pain After Ankle Fracture Surgery,COMPLETED,,PHASE4,14.0,ACTUAL,University of Cincinnati,"A problem encountered was that only 1 of the 6 subjects in the pump group received the full 5 days of treatment. The others discontinued using the pump early, primarily due to problems with catheter dislodgement/leakage. As specified in the statistical analysis plan, these subjects were all analyzed with intent-to-treat protocol and are included in the pump group data presented. Also, by chance, the distribution of males and females between the group was quite uneven.",2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,OTHER,,,,,,,2020,1.0
NCT04379713,,2020-05-06,2023-05-18,,2023-05-18,2020-05-06,2020-05-07,ACTUAL,2023-05-18,2023-06-13,ACTUAL,,,,2023-05-18,2023-06-13,ACTUAL,2020-05-21,ACTUAL,2020-05-21,2023-05,2023-05-31,2022-08-31,ACTUAL,2022-08-31,2022-08-31,ACTUAL,2022-08-31,,INTERVENTIONAL,,Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received any incorrect study vaccination during the study was excluded.,20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants,"A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS",COMPLETED,,PHASE3,1511.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,INDUSTRY,,,,,,,2022,0.0
NCT03103971,,2017-03-27,,,2024-04-08,2017-03-31,2017-04-07,ACTUAL,,,,,,,2024-04-08,2024-04-10,ACTUAL,2017-11-03,ACTUAL,2017-11-03,2024-04,2024-04-30,2024-03-23,ACTUAL,2024-03-23,2023-03-23,ACTUAL,2023-03-23,,INTERVENTIONAL,,,huJCAR014 CAR-T Cells in Treating Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia,"A Two-Stage Phase 1 Open-Label Study of huJCAR014, CD19-Targeted Chimeric Antigen Receptor (CAR)-Modified T Cells Bearing a Human Binding Domain, in Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Acute Lymphocytic Leukemia",TERMINATED,,PHASE1,55.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,Terminated due to slow enrollment and end of funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,OTHER,,,,,,,2024,0.0
NCT04428047,,2020-06-02,,,2022-03-28,2020-06-09,2020-06-11,ACTUAL,,,,,,,2022-03-28,2022-04-06,ACTUAL,2021-02-04,ACTUAL,2021-02-04,2022-03,2022-03-31,2022-01-07,ACTUAL,2022-01-07,2021-09-04,ACTUAL,2021-09-04,,INTERVENTIONAL,ICING,,Evaluation of Bintrafusp Alfa in Operable and Untreated Head and Neck Squamous Cell Carcinoma,"A Phase II Trial Assessing Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in a Pre-operative Setting for Resectable and Untreated Head and Neck Squamous Cell Carcinoma",TERMINATED,,PHASE2,7.0,ACTUAL,UNICANCER,,1.0,,Sponsor decision following information on cases of hyperprogression and early toxicities with bintrafusp alfa in other studies,f,,,,t,f,f,,,,,,,,,NO,Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,OTHER,,,,,,,2022,0.0
NCT02627963,,2015-12-09,2020-01-16,,2023-06-27,2015-12-10,2015-12-11,ESTIMATED,2020-02-10,2020-02-20,ACTUAL,,,,2023-06-27,2023-07-18,ACTUAL,2016-05-24,ACTUAL,2016-05-24,2023-06,2023-06-30,2021-06-21,ACTUAL,2021-06-21,2018-10-04,ACTUAL,2018-10-04,,INTERVENTIONAL,,,A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC),"A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma",COMPLETED,,PHASE3,350.0,ACTUAL,"AVEO Pharmaceuticals, Inc.",,2.0,,,f,,,,f,,,,,,,,,,,UNDECIDED,,2024-10-16 16:00:55.776746,2024-10-16 16:00:55.776746,INDUSTRY,,,,,,,2021,1.0
NCT02666742,,2016-01-25,2021-07-30,,2022-08-18,2016-01-25,2016-01-28,ESTIMATED,2021-08-30,2021-09-24,ACTUAL,,,,2022-08-18,2022-08-22,ACTUAL,2017-02-16,ACTUAL,2017-02-16,2021-08,2021-08-31,2021-04-30,ACTUAL,2021-04-30,2020-05-01,ACTUAL,2020-05-01,,INTERVENTIONAL,STROKE-VT,"Patients undergoing VT or PVC ablation are enrolled into the study. Baseline characteristics of patients including demographics, comorbidities, cardiac function etc were collected and analyzed",DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation,SafeTy and Efficacy of Direct Oral Anticoagulant Versus Aspirin for Reduction Of RisK of CErebrovascular Events in Patients Undergoing Ventricular Tachycardia Ablation (STROKE-VT),COMPLETED,,PHASE4,246.0,ACTUAL,Kansas City Heart Rhythm Institute,"Our results should be considered in light of several significant limitations. An important limitation was the lack of long-term follow-up and quality-of-life and neurocognitive function information. Another methodological limitation of the outcomes was that the ASA group did not get a loading dose, perhaps the delay in achieving the therapeutic effects in denovo ASA initiation could increase the risk of events.",2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,OTHER,,,,,,,2021,1.0
NCT02959658,,2016-11-08,,,2020-12-22,2016-11-08,2016-11-09,ESTIMATED,,,,,,,2020-12-22,2020-12-24,ACTUAL,2016-12,ACTUAL,2016-12-31,2020-12,2020-12-31,2020-12-09,ACTUAL,2020-12-09,2019-12-21,ACTUAL,2019-12-21,,INTERVENTIONAL,FUMAPMS,,Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis,Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis,COMPLETED,,PHASE2,54.0,ACTUAL,"Rigshospitalet, Denmark",,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,OTHER,,,,,,,2020,0.0
NCT05293106,,2022-03-14,2024-06-17,,2024-07-30,2022-03-14,2022-03-24,ACTUAL,2024-07-30,2024-08-20,ACTUAL,,,,2024-07-30,2024-08-20,ACTUAL,2022-07-05,ACTUAL,2022-07-05,2024-07,2024-07-31,2023-09-27,ACTUAL,2023-09-27,2023-09-17,ACTUAL,2023-09-17,,INTERVENTIONAL,PEDITREC,,Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial,Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial,TERMINATED,,PHASE4,9.0,ACTUAL,Weill Medical College of Cornell University,"Due to difficulty in recruiting and enrolling subjects, only descriptive statistics were used to describe the 9 enrolled subjects.",3.0,,Difficulty recruiting and enrolling subjects.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 16:00:55.776746,2024-10-16 16:00:55.776746,OTHER,,,,,,,2023,0.0
NCT04365400,,2020-04-24,2023-05-05,,2023-06-08,2020-04-24,2020-04-28,ACTUAL,2023-05-05,2023-06-01,ACTUAL,,,,2023-06-08,2023-06-12,ACTUAL,2020-10-13,ACTUAL,2020-10-13,2023-06,2023-06-30,2022-05-03,ACTUAL,2022-05-03,2022-05-03,ACTUAL,2022-05-03,,INTERVENTIONAL,TRIAGE,Safety Analysis Set: The SAS consists of all patients who received at least one dose of the study medication.,Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes,"A Randomised, Double-Blind, Placebo-Controlled, Dose Finding Phase IIb Study to Assess the Efficacy and Safety of Orally Administered Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes",TERMINATED,,PHASE2,233.0,ACTUAL,Afimmune,,3.0,,Trial prematurely terminated on 03 May 2022 due to the results from an interim analysis indicating a lack of efficacy in the study population.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:39:08.361117,2024-10-15 17:39:08.361117,INDUSTRY,,,,,,,2022,0.0
NCT04530747,,2020-08-25,2022-11-21,,2022-12-21,2020-08-25,2020-08-28,ACTUAL,2022-12-21,2023-01-19,ACTUAL,,,,2022-12-21,2023-01-19,ACTUAL,2021-01-28,ACTUAL,2021-01-28,2022-12,2022-12-31,2021-11-30,ACTUAL,2021-11-30,2021-11-30,ACTUAL,2021-11-30,,INTERVENTIONAL,MET-OSA,,Metabolic Effects of Metformin Therapy in Obstructive Sleep Apnea,Metabolic Effects of Metformin Therapy in Obstructive Sleep Apnea,TERMINATED,,PHASE1/PHASE2,16.0,ACTUAL,Pennington Biomedical Research Center,Early termination due to PAP recall.,2.0,,Recall of positive airway pressure (PAP) device.,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 18:03:23.937454,2024-10-15 18:03:23.937454,OTHER,,,,,,,2021,0.0
NCT01468311,,2011-11-05,2017-04-17,,2021-09-16,2011-11-05,2011-11-09,ESTIMATED,2017-04-17,2017-05-25,ACTUAL,,,,2021-09-16,2021-10-06,ACTUAL,2011-10-11,ACTUAL,2011-10-11,2021-09,2021-09-30,2020-10-22,ACTUAL,2020-10-22,2014-11-16,ACTUAL,2014-11-16,,INTERVENTIONAL,,,Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin's Lymphoma,Phase I/II Trial of Yttrium-90-labeled Daclizumab (Anti-CD25) Radioimmunotherapy With High-dose BEAM Chemotherapy and Autologous Hematopoietic Stem Cell Rescue in Recurrent and Refractory Hodgkin's Lymphoma,TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,Poor enrollment and ability to radioconjugate Daclizumab. Neither Center for Cancer Research (CCR) or Nuclear Medicine/Radiology wanted to do the facilities upgrade and hire personnel needed to radioconjugate the drug at the Clinical Center.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,NIH,,,,,,,2020,0.0
NCT03492138,,2018-03-22,,,2020-05-27,2018-04-02,2018-04-10,ACTUAL,,,,,,,2020-05-27,2020-05-29,ACTUAL,2018-03-26,ACTUAL,2018-03-26,2020-05,2020-05-31,2020-01-14,ACTUAL,2020-01-14,2020-01-14,ACTUAL,2020-01-14,,INTERVENTIONAL,,,"Ixazomib, ONC201, and Dexamethasone in Relapsed/Refractory Multiple Myeloma",A Phase I/II Study of the Addition of Ixazomib to ONC201 and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma,TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,1.0,,Low enrollment,f,,,,t,t,f,,,,,,,,,UNDECIDED,"Data and safety will be monitored using an internal Data and Safety Monitoring Plan (DSMP) led by the PI. Other members involved with the review will include sub-Investigators, the myeloma research program manager, and clinical research coordinators. All of these individuals have experience in the routine clinical care as well clinical research and monitoring of subjects with multiple myeloma. A statistician will also be involved with the review.",2024-10-16 16:00:55.776746,2024-10-16 16:00:55.776746,OTHER,,,,,,,2020,0.0
NCT04852978,,2021-04-19,2023-11-20,,2024-07-25,2021-04-19,2021-04-21,ACTUAL,2024-07-25,2024-08-20,ACTUAL,,,,2024-07-25,2024-08-20,ACTUAL,2021-04-29,ACTUAL,2021-04-29,2024-07,2024-07-31,2022-11-21,ACTUAL,2022-11-21,2022-11-21,ACTUAL,2022-11-21,,INTERVENTIONAL,,The safety analysis set (SAF) includes all randomized subjects who have been vaccinated with at least one dose or received any study drug,"COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers","A Phase 2 Randomized, Open-Label, Parallel Group Study to Assess the Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers",COMPLETED,,PHASE2,295.0,ACTUAL,Regeneron Pharmaceuticals,,12.0,,,t,,,,f,t,f,,,,,,"When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.",Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf,https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-16 16:00:55.776746,2024-10-16 16:00:55.776746,INDUSTRY,,NCT04617535,NO_LONGER_AVAILABLE,,,,2022,1.0
NCT03930732,,2019-04-26,2024-01-30,,2024-01-30,2019-04-26,2019-04-29,ACTUAL,2024-01-30,2024-02-28,ACTUAL,,,,2024-01-30,2024-02-28,ACTUAL,2019-04-15,ACTUAL,2019-04-15,2024-01,2024-01-31,2023-05-02,ACTUAL,2023-05-02,2023-02-08,ACTUAL,2023-02-08,,INTERVENTIONAL,BOREAS,The Randomized population consisted of any participant who was allocated to a randomized treatment regardless of whether the treatment kit was used.,"Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation","A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation",COMPLETED,,PHASE3,939.0,ACTUAL,Sanofi,,2.0,,,,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 16:00:55.776746,2024-10-16 16:00:55.776746,INDUSTRY,,,,,,,2023,1.0
NCT04994535,,2021-07-29,2024-06-12,,2024-07-24,2021-08-04,2021-08-06,ACTUAL,2024-07-24,2024-08-20,ACTUAL,,,,2024-07-24,2024-08-20,ACTUAL,2021-08-10,ACTUAL,2021-08-10,2024-07,2024-07-31,2023-06-14,ACTUAL,2023-06-14,2023-06-14,ACTUAL,2023-06-14,,INTERVENTIONAL,,"Baseline analyses were performed on the ITT population, consisting of all randomized participants.",A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence,"A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence",COMPLETED,,PHASE3,426.0,ACTUAL,AbbVie,,2.0,,,f,,,,f,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 16:00:55.776746,2024-10-16 16:00:55.776746,INDUSTRY,,,,,,,2023,1.0
NCT03531827,,2018-05-18,2022-05-02,,2022-06-16,2018-05-19,2018-05-22,ACTUAL,2022-06-16,2022-07-12,ACTUAL,,,,2022-06-16,2022-07-12,ACTUAL,2019-03-26,ACTUAL,2019-03-26,2022-06,2022-06-30,2021-06-01,ACTUAL,2021-06-01,2021-05-15,ACTUAL,2021-05-15,,INTERVENTIONAL,,,"Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment","A Single Arm Phase II Study Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in Patients With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment",TERMINATED,,PHASE2,4.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,Study was closed for toxicity.,f,,,,f,t,f,,,,,,Clinical data available during the study and indefinitely.,Clinical data will be made available via subscription to the Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).,,YES,All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.~All collected IPD will be shared with collaborators under the terms of collaborative agreements.,2024-10-16 16:00:55.776746,2024-10-16 16:00:55.776746,NIH,,,,,,,2021,0.0
NCT03499353,,2018-04-09,2021-08-20,,2021-10-11,2018-04-09,2018-04-17,ACTUAL,2021-10-11,2021-11-09,ACTUAL,,,,2021-10-11,2021-11-09,ACTUAL,2018-08-27,ACTUAL,2018-08-27,2021-10,2021-10-31,2020-09-23,ACTUAL,2020-09-23,2020-09-23,ACTUAL,2020-09-23,,INTERVENTIONAL,,Baseline analysis population included all participants who received any amount of talazoparib.,Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer,"A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER",TERMINATED,,PHASE2,61.0,ACTUAL,Pfizer,The study was prematurely terminated by the sponsor due to a change in clinical development strategy not related to safety or efficacy after all participants completed safety follow-up.,1.0,,This study was terminated based on Pfizer's change in clinical development strategy not related to safety and efficacy.,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 16:00:55.776746,2024-10-16 16:00:55.776746,INDUSTRY,,,,,,,2020,0.0
NCT05116774,,2021-11-02,,,2024-02-22,2021-11-02,2021-11-11,ACTUAL,,,,,,,2024-02-22,2024-02-23,ACTUAL,2021-12-06,ACTUAL,2021-12-06,2022-12,2022-12-31,2023-09-14,ACTUAL,2023-09-14,2023-09-14,ACTUAL,2023-09-14,,INTERVENTIONAL,REDEEM-1,,BCX9930 for Treatment of PNH in Subjects With Inadequate Response to C5 Inhibitor Therapy,"A Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of PNH in Subjects With Inadequate Response to C5 Inhibitor Therapy",TERMINATED,,PHASE2,12.0,ACTUAL,BioCryst Pharmaceuticals,,2.0,,Sponsor decision,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,INDUSTRY,,,,,,,2023,0.0
NCT03041311,,2017-02-01,2022-01-07,2019-07-18,2022-04-08,2017-02-01,2017-02-02,ESTIMATED,2022-04-08,2022-05-06,ACTUAL,2022-04-08,2022-05-06,ACTUAL,2022-04-08,2022-05-06,ACTUAL,2017-06-29,ACTUAL,2017-06-29,2022-04,2022-04-30,2020-10-29,ACTUAL,2020-10-29,2018-08-17,ACTUAL,2018-08-17,,INTERVENTIONAL,,,"Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC","Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib in Patients With Untreated Extensive-Stage Small Cell Lung Cancer (SCLC)",TERMINATED,,PHASE2,107.0,ACTUAL,"G1 Therapeutics, Inc.","Limitation of the trial is small numbers of subjects, since it is a Phase 2 clinical trial.~Small sample size may have reduced the ability to observe statistically significant treatment effects on secondary myelopreservation measures (i.e. occurrence of FN AEs, infections and antibiotics usage).",2.0,,Primary Analysis and survival follow up completed per protocol. Not stopped due to safety concerns.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,INDUSTRY,,,,,,,2020,0.0
NCT04946864,,2021-06-23,,,2024-08-16,2021-06-23,2021-07-01,ACTUAL,,,,,,,2024-08-16,2024-08-19,ACTUAL,2021-08-13,ACTUAL,2021-08-13,2024-08,2024-08-31,2024-10-01,ESTIMATED,2024-10-01,2024-08-12,ACTUAL,2024-08-12,,INTERVENTIONAL,,,"A Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination for Breast Cancer","A Phase Ib/II Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination With Systemic Anti-cancer Agents in Patients With ER Positive Breast Cancer or Advanced Solid Tumors.",SUSPENDED,,PHASE1/PHASE2,65.0,ESTIMATED,Ascentage Pharma Group Inc.,,2.0,,Company Decision,,,,,f,t,f,,,,,,,,,NO,,2024-10-16 16:00:55.776746,2024-10-16 16:00:55.776746,INDUSTRY,,,,,,,2024,0.0
NCT03865563,,2019-03-05,,,2020-01-22,2019-03-05,2019-03-07,ACTUAL,,,,,,,2020-01-22,2020-01-27,ACTUAL,2019-07,ESTIMATED,2019-07-31,2020-01,2020-01-31,2021-12,ESTIMATED,2021-12-31,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,Selective Transvenous Chemoembolization of Primary Pancreatic Tumors,Selective Transvenous Chemoembolization of Primary Pancreatic Tumors,WITHDRAWN,,PHASE1,0.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,We need to make significant adjustments to proposed drug and its delivery method,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 16:00:55.776746,2024-10-16 16:00:55.776746,OTHER,,,,,,,2021,0.0
NCT03849456,,2019-02-20,,2021-05-25,2022-08-31,2019-02-20,2019-02-21,ACTUAL,,,,2021-05-25,2021-05-27,ACTUAL,2022-08-31,2022-09-02,ACTUAL,2020-01-07,ACTUAL,2020-01-07,2022-08,2022-08-31,2020-05-26,ACTUAL,2020-05-26,2020-05-26,ACTUAL,2020-05-26,,INTERVENTIONAL,,,Safety and Tolerability of Cannabidivarin (CBDV) in Children and Young Adults With Autism Spectrum Disorder,Safety and Tolerability of GWP42006 in Children and Young Adults With Autism Spectrum Disorder,TERMINATED,,PHASE2,1.0,ACTUAL,Jazz Pharmaceuticals,,1.0,,Study terminated due to enrollment challenges during COVID-19 pandemic.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,INDUSTRY,,,,,,,2020,0.0
NCT05369390,,2022-05-04,,,2024-07-02,2022-05-10,2022-05-11,ACTUAL,,,,,,,2024-07-02,2024-07-03,ACTUAL,2022-05-11,ACTUAL,2022-05-11,2024-07,2024-07-31,2024-01-09,ACTUAL,2024-01-09,2024-01-09,ACTUAL,2024-01-09,,INTERVENTIONAL,,,A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity,"Safety, Tolerability and Pharmacokinetics of NNC0487-0111 in Participants With Overweight or Obesity",COMPLETED,,PHASE1,144.0,ACTUAL,Novo Nordisk A/S,,4.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,INDUSTRY,,,,,,,2024,1.0
NCT01990352,,2013-11-08,2023-10-02,,2023-11-02,2013-11-15,2013-11-21,ESTIMATED,2023-10-02,2023-10-26,ACTUAL,,,,2023-11-02,2023-11-21,ACTUAL,2013-11-05,ACTUAL,2013-11-05,2023-11,2023-11-30,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,Correlate BRCA1 Protein Expression With Response to DNA Damaging Chemotherapy,A Single Arm Phase II Trial to Assess Association of BRCA1 Protein Expression With Overall Response Rate in Patients With Metastatic Breast Cancer on Pegylated Liposomal Doxorubicin,TERMINATED,,PHASE2,24.0,ACTUAL,University of Arizona,"The trial was started with preliminary data on BRCA1 immunohistochemistry assay developed with a collaborator. The assay, in the trial, due to differences in the timeline on when the tumor tissue was collected, the variability in the tumor tissue processing, storage, and age of the samples, the assay did not work on the samples as projected. Subsequently, due to COVID-19 and the challenges with the assay performance, the collaborator discontinued further development of the assay.",1.0,,The PI determined that study specimens being obtained did not yield sufficient data to analyze the prespecified outcome measures and decided to terminate the study prior to meeting enrollment goals.,f,,,,t,,,,,,,,,,,,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,OTHER,,,,,,,2022,0.0
NCT03569007,,2018-06-14,,,2022-07-22,2018-06-14,2018-06-26,ACTUAL,,,,,,,2022-07-22,2022-07-26,ACTUAL,2019-05-29,ACTUAL,2019-05-29,2021-08,2021-08-31,2022-07-21,ACTUAL,2022-07-21,2022-07-21,ACTUAL,2022-07-21,,INTERVENTIONAL,,,Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms,"A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of Persistent Symptoms in Patients With Celiac Disease on a GFD",TERMINATED,,PHASE3,307.0,ACTUAL,"9 Meters Biopharma, Inc.",,3.0,,Trial terminated by Sponsor,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,INDUSTRY,,,,,,,2022,0.0
NCT04124510,,2019-09-30,,,2021-01-21,2019-10-10,2019-10-11,ACTUAL,,,,,,,2021-01-21,2021-01-25,ACTUAL,2019-11-26,ACTUAL,2019-11-26,2021-01,2021-01-31,2020-09-14,ACTUAL,2020-09-14,2020-09-14,ACTUAL,2020-09-14,,INTERVENTIONAL,SWIFT,,Efficacy and Safety of Flutiform K-haler in Patients With Uncontrolled Asthma Following Mid-dose ICS/LABA DPI Therapy,"An 12-week, Prospective, Interventional, Single-arm, Multi-centre, Phase III Study to Examine the Efficacy and Safety of Flutiform K-haler in Asthma Patients Who Are Not Adequately Controlled by Mid-doseICS/LABA DPI Treatment",TERMINATED,,PHASE3,20.0,ACTUAL,Mundipharma Korea Ltd,,1.0,,"The Contract of K-haler products had been terminated between Mundipharma and provider. Therefore, this clinical trial was terminated early.",f,,,,f,f,f,,,,,,,,,,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,INDUSTRY,,,,,,,2020,0.0
NCT04102111,,2019-09-23,2022-11-11,,2022-11-11,2019-09-23,2019-09-25,ACTUAL,2022-11-11,2022-12-09,ACTUAL,,,,2022-11-11,2022-12-09,ACTUAL,2019-09-23,ACTUAL,2019-09-23,2022-11,2022-11-30,2021-12-22,ACTUAL,2021-12-22,2021-11-17,ACTUAL,2021-11-17,,INTERVENTIONAL,PRISM,,A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease,"A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants With Moderately to Severely Active Crohn's Disease",TERMINATED,,PHASE2,48.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,"IAC completed review of futility analysis data \& determined that futility criteria were met. As a result, Janssen made decision to stop trial immediately.",f,,,,t,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,INDUSTRY,,,,,,,2021,0.0
NCT04432298,,2020-06-12,2022-04-27,,2022-07-14,2020-06-12,2020-06-16,ACTUAL,2022-07-14,2022-07-18,ACTUAL,,,,2022-07-14,2022-07-18,ACTUAL,2020-06-20,ACTUAL,2020-06-20,2022-06,2022-06-30,2021-03-22,ACTUAL,2021-03-22,2021-03-22,ACTUAL,2021-03-22,,INTERVENTIONAL,,ITT population: All randomized participants.,"Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease","Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of the Efficacy and Safety of Intravenous Pamrevlumab, a Monoclonal Antibody Against Connective Tissue Growth Factor (CTGF), in Hospitalized Patients With Acute COVID-19 Disease",TERMINATED,,PHASE2,22.0,ACTUAL,FibroGen,"Due to early termination of this study, formal analyses of the primary and secondary endpoints are not presented because the study's sample size is substantially underpowered for meaningful interpretation.",2.0,,The study was terminated by Sponsor due to low enrollment.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,INDUSTRY,,,,,,,2021,0.0
NCT03644550,,2018-08-22,2021-10-13,,2021-11-03,2018-08-22,2018-08-23,ACTUAL,2021-11-03,2021-12-02,ACTUAL,,,,2021-11-03,2021-12-02,ACTUAL,2018-12-04,ACTUAL,2018-12-04,2021-11,2021-11-30,2020-11-02,ACTUAL,2020-11-02,2020-08-05,ACTUAL,2020-08-05,,INTERVENTIONAL,,,Anti-Mesothelin Immunotoxin LMB-100 Followed by Pembrolizumab in Malignant Mesothelioma,Phase II Study of the Anti-Mesothelin Immunotoxin LMB-100 Followed by Pembrolizumab in Malignant Mesothelioma,TERMINATED,,PHASE2,18.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,"Due to the Food and Drug Administration's recent approval of Nivolumab plus Ipilimumab as first line treatment for Mesothelioma, the principal investigator decided to end the study early (prior to reaching enrollment goal).",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,NIH,,,,,,,2020,0.0
NCT02125461,,2014-04-25,2018-02-13,,2023-09-21,2014-04-25,2014-04-29,ESTIMATED,2019-01-28,2019-01-30,ACTUAL,,,,2023-09-21,2023-10-10,ACTUAL,2014-05-07,ACTUAL,2014-05-07,2023-09,2023-09-30,2023-08-24,ACTUAL,2023-08-24,2017-02-13,ACTUAL,2017-02-13,,INTERVENTIONAL,PACIFIC,Baseline analysis was based on the FAS consisting of all randomized patients.,A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer,"A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)",COMPLETED,,PHASE3,713.0,ACTUAL,AstraZeneca,Results of interim PFS analysis are considered as final PFS analysis; results of interim OS analysis are considered as final OS analysis. Patients were followed up for long-term survival until approximately 5 years after last patient enrolled.,2.0,,,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,INDUSTRY,,,,,,,2023,1.0
NCT02931539,,2016-09-29,2021-08-09,,2021-10-29,2016-10-10,2016-10-13,ESTIMATED,2021-09-22,2021-09-23,ACTUAL,,,,2021-10-29,2021-11-03,ACTUAL,2016-12-22,ACTUAL,2016-12-22,2021-09,2021-09-30,2020-08-17,ACTUAL,2020-08-17,2020-08-17,ACTUAL,2020-08-17,,INTERVENTIONAL,,"The randomized set consisted of all participants who had signed an informed consent and had begun some study procedures, and randomized to the study.","Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir","A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir",COMPLETED,,PHASE3,352.0,ACTUAL,Takeda,,2.0,,,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,INDUSTRY,,,,,,,2020,1.0
NCT02307500,,2014-11-25,,,2022-09-09,2014-12-03,2014-12-04,ESTIMATED,,,,,,,2022-09-09,2022-09-10,ACTUAL,2014-12,,2014-12-31,2022-09,2022-09-30,2020-08,ACTUAL,2020-08-31,2017-12,ACTUAL,2017-12-31,,INTERVENTIONAL,RESOUND,,Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy,An Open-label Phase II Study of Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy - RESOUND,COMPLETED,,PHASE2,82.0,ACTUAL,Istituto Clinico Humanitas,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,OTHER,,,,,,,2020,1.0
NCT03031730,,2017-01-25,,,2024-08-01,2017-01-25,2017-01-26,ESTIMATED,,,,,,,2024-08-01,2024-08-02,ACTUAL,2018-06-14,ACTUAL,2018-06-14,2024-07,2024-07-31,2024-07-24,ACTUAL,2024-07-24,2024-07-24,ACTUAL,2024-07-24,,INTERVENTIONAL,,,Testing the Addition of KRT-232 (AMG 232) to Usual Chemotherapy for Relapsed Multiple Myeloma,"A Phase 1 Dose-Escalation and Exploratory Dose Expansion Study of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomide, and Dexamethasone in Relapsed and/or Refractory Myeloma",TERMINATED,,PHASE1,35.0,ACTUAL,National Cancer Institute (NCI),,1.0,,Inadequate accrual rate,f,,,,f,t,f,,,,,,,,,,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,NIH,,,,,,,2024,0.0
NCT04593329,,2020-10-13,,,2023-09-05,2020-10-13,2020-10-20,ACTUAL,,,,,,,2023-09-05,2023-09-08,ACTUAL,2023-03,ESTIMATED,2023-03-31,2023-09,2023-09-30,2023-12,ESTIMATED,2023-12-31,2023-08,ESTIMATED,2023-08-31,,INTERVENTIONAL,,,Efficacy and Safety of Tiradentes Association in the Treatment of Acute Pain,"National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tiradentes Association in the Treatment of Acute Pain",WITHDRAWN,,PHASE2,0.0,ACTUAL,EMS,,3.0,,Strategy review,f,,,,t,f,f,,,,,,,,,,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,INDUSTRY,,,,,,,2023,0.0
NCT03306394,,2017-08-02,,,2024-07-24,2017-10-04,2017-10-11,ACTUAL,,,,,,,2024-07-24,2024-07-25,ACTUAL,2016-10-18,ACTUAL,2016-10-18,2024-07,2024-07-31,2020-11-30,ACTUAL,2020-11-30,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,PRECONNECT,,A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic).,An Open-label Early Access Phase IIIb Study of Trifluridine / Tipiracil (S 95005/TAS-102) in Patients With a Pretreated Metastatic Colorectal Cancer (PRECONNECT),COMPLETED,,PHASE3,907.0,ACTUAL,Servier,,1.0,,,f,,,,f,,f,,,t,,,After Marketing Authorisation in EEA or US if the study is used for the approval.,Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.,http://clinicaltrials.servier.com,YES,"Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.",2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,INDUSTRY,,,,,,,2020,1.0
NCT05417386,,2022-06-07,,,2024-06-21,2022-06-09,2022-06-14,ACTUAL,,,,,,,2024-06-21,2024-06-25,ACTUAL,2022-08-09,ACTUAL,2022-08-09,2024-06,2024-06-30,2023-07-10,ACTUAL,2023-07-10,2023-07-10,ACTUAL,2023-07-10,,INTERVENTIONAL,,,FOLFIRINOX + NIS793 in Pancreatic Cancer,A Phase IB Study FOLFIRINOX and NIS793 in Patients With Pancreatic Cancer,TERMINATED,,PHASE1,4.0,ACTUAL,Massachusetts General Hospital,,3.0,,NIS793 is no longer being developed,f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,Contact the Partners Innovations team at http://www.partners.org/innovation,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,OTHER,,,,,,,2023,0.0
NCT03318159,,2017-10-10,,,2024-04-16,2017-10-18,2017-10-23,ACTUAL,,,,,,,2024-04-16,2024-04-17,ACTUAL,2018-04-20,ACTUAL,2018-04-20,2024-04,2024-04-30,2023-07-15,ACTUAL,2023-07-15,2023-07-15,ACTUAL,2023-07-15,,INTERVENTIONAL,,,Posaconazole Prophylaxis During ATG Treatment for hMDS/AA Patients,"Open Label, Phase II Study Investigating the Efficacy of Posaconazole as Prophylaxis Antifungal Agent in Aplastic Anemia / Hypoplastic Myelodysplastic Syndrome Patients Undergoing Antithymocyte Globulin Treatment",COMPLETED,,PHASE2,20.0,ACTUAL,Seoul National University Hospital,,1.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,OTHER,,,,,,,2023,0.0
NCT03681093,,2018-09-20,2020-12-09,,2021-10-07,2018-09-20,2018-09-21,ACTUAL,2020-12-09,2021-01-05,ACTUAL,,,,2021-10-07,2021-10-11,ACTUAL,2019-03-26,ACTUAL,2019-03-26,2021-10,2021-10-31,2020-06-10,ACTUAL,2020-06-10,2020-05-29,ACTUAL,2020-05-29,,INTERVENTIONAL,THUNDER,,Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma,"A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Fevipiprant Once Daily Plus Standard-of-care (SoC) for Assessment of the Efficacy in Reduction of Nasal Polyp Size in Patients With Nasal Polyposis and Concomitant Asthma.",COMPLETED,,PHASE3,98.0,ACTUAL,Novartis,,3.0,,,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,INDUSTRY,,,,,,,2020,1.0
NCT03935815,,2019-02-26,,,2021-04-26,2019-05-01,2019-05-02,ACTUAL,,,,,,,2021-04-26,2021-04-28,ACTUAL,2019-05-01,ACTUAL,2019-05-01,2021-04,2021-04-30,2020-06-08,ACTUAL,2020-06-08,2020-06-06,ACTUAL,2020-06-06,,INTERVENTIONAL,,,Quadratus Lumborum Nerve Blocks for Myomectomies,Quadratus Lumborum Nerve Blocks in Laparoscopic Myomectomy Patients,TERMINATED,,PHASE1,26.0,ACTUAL,"University of California, Los Angeles",,2.0,,Closed prior to completion secondary to surgeon leaving UCLA,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,OTHER,,,,,,,2020,0.0
NCT03568071,,2018-05-31,,,2020-03-16,2018-06-13,2018-06-26,ACTUAL,,,,,,,2020-03-16,2020-03-18,ACTUAL,2018-04-26,ACTUAL,2018-04-26,2020-03,2020-03-31,2020-03-03,ACTUAL,2020-03-03,2020-03-03,ACTUAL,2020-03-03,,INTERVENTIONAL,IGUANA,,"A Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics (PK)/Pharmacodynamics (PD) of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis","A Phase II, Randomized, Double-blind, Placebo-controlled Repeated-dose Study to Evaluate the Efficacy, Safety, Tolerability,and PK/PD of Intravenously Administered MOR106 in Adult Subjects With Moderate to Severe Atopic Dermatitis",TERMINATED,,PHASE2,207.0,ACTUAL,Galapagos NV,,6.0,,MOR106 clinical development in atopic dermatitis was stopped for futility,f,,,,,f,f,,,,,,,,,,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,INDUSTRY,,,,,,,2020,0.0
NCT01196390,,2010-09-04,2021-03-01,,2023-08-16,2010-09-04,2010-09-08,ESTIMATED,2021-04-12,2021-05-04,ACTUAL,,,,2023-08-16,2023-09-07,ACTUAL,2011-02-14,ACTUAL,2011-02-14,2023-08,2023-08-31,2023-08-15,ACTUAL,2023-08-15,2019-12-23,ACTUAL,2019-12-23,,INTERVENTIONAL,,Eligible participants,"Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer",A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma,COMPLETED,,PHASE3,203.0,ACTUAL,National Cancer Institute (NCI),"Due to a considerable decrease in the overall rate of new disease-free survival events, the NRG Data Monitoring Committee (DMC) determined that the study would not reach the required 162 events in a reasonable amount of time. With power from the observed number of events calculated to be greater than 80%, the DMC recommended releasing the results for reporting.",2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,NIH,,,,,,,2023,1.0
NCT03721107,,2018-10-01,2021-09-06,,2021-12-22,2018-10-24,2018-10-26,ACTUAL,2021-12-22,2022-01-11,ACTUAL,,,,2021-12-22,2022-01-11,ACTUAL,2018-10-11,ACTUAL,2018-10-11,2021-12,2021-12-31,2020-05-13,ACTUAL,2020-05-13,2020-05-13,ACTUAL,2020-05-13,,INTERVENTIONAL,,Safety Analysis Set (SAF) included all participants randomized into the study who received at least one dose of Blautix or Placebo.,A Trial for New Treatment of Adult Participants With Irritable Bowel Syndrome,"A Phase II Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of Repeated Oral Doses of Blautix in Adult Subjects With Irritable Bowel Syndrome (IBS) Subtypes IBS-C and IBS-D",COMPLETED,,PHASE2,366.0,ACTUAL,4D pharma plc,,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,INDUSTRY,,,,,,,2020,1.0
NCT05479058,,2022-07-26,2024-09-09,,2024-09-09,2022-07-26,2022-07-29,ACTUAL,2024-09-09,2024-10-04,ACTUAL,,,,2024-09-09,2024-10-04,ACTUAL,2022-07-26,ACTUAL,2022-07-26,2024-09,2024-09-30,2023-10-09,ACTUAL,2023-10-09,2023-10-09,ACTUAL,2023-10-09,,INTERVENTIONAL,CAPYBARA,Safety Analysis Set included all randomized participants who were administered study drug at least once.,A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission,"A Randomized, Double-blind, Controlled, Multi-center Study to Evaluate the Efficacy and Safety of Dose De-escalation of Orally Administered Filgotinib in Subjects With Ulcerative Colitis in Clinical Remission",TERMINATED,,PHASE3,22.0,ACTUAL,Galapagos NV,"This study was terminated as the planned number of participants needed to ensure adequate precision in the estimations and to draw meaningful conclusions was unlikely to be met, questioning the scientific value and ethical grounds for study continuation.",2.0,,"the planned number of participants needed to ensure adequate precision in the estimations and to draw meaningful conclusions was unlikely to be met, questioning the scientific value and ethical grounds for study continuation",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,INDUSTRY,,,,,,,2023,0.0
NCT02766478,,2016-05-06,2022-07-18,,2022-09-07,2016-05-06,2016-05-09,ESTIMATED,2022-09-07,2022-09-27,ACTUAL,,,,2022-09-07,2022-09-27,ACTUAL,2017-10-16,ACTUAL,2017-10-16,2022-09,2022-09-30,2021-07-23,ACTUAL,2021-07-23,2021-07-23,ACTUAL,2021-07-23,,INTERVENTIONAL,GeniPro,,Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer,Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer,TERMINATED,,PHASE2,10.0,ACTUAL,Emory University,,2.0,,Enrollment and study activities were suspended due to COVID-19.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,OTHER,,,,,,,2021,0.0
NCT03031821,,2017-01-20,,,2024-10-03,2017-01-25,2017-01-26,ESTIMATED,,,,,,,2024-10-03,2024-10-04,ACTUAL,2018-07-12,ACTUAL,2018-07-12,2024-10,2024-10-31,2023-11-24,ACTUAL,2023-11-24,2023-11-24,ACTUAL,2023-11-24,,INTERVENTIONAL,PRIME,,Metformin in Patients Initiating ADT as Prevention and Intervention of Metabolic Syndrome,A Randomized Phase 3 Trial of Metformin in Patients Initiating Androgen Deprivation Therapy as Prevention and Intervention of Metabolic Syndrome: The Prime Study,TERMINATED,,PHASE3,168.0,ACTUAL,Canadian Urologic Oncology Group,,2.0,,Manufacturer discontinued the production of study drugs.,f,,,,t,f,f,,,,,,,,,,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,OTHER,,,,,,,2023,0.0
NCT04020718,,2019-07-12,2022-01-21,,2022-02-14,2019-07-12,2019-07-16,ACTUAL,2022-02-14,2022-03-10,ACTUAL,,,,2022-02-14,2022-03-10,ACTUAL,2020-01-31,ACTUAL,2020-01-31,2022-02,2022-02-28,2020-11-30,ACTUAL,2020-11-30,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,,,Engagement With an Adaptive Mobile Health Smoking Cessation Intervention,Engagement With an Adaptive Mobile Health Smoking Cessation Intervention,COMPLETED,,PHASE4,35.0,ACTUAL,Massachusetts General Hospital,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,OTHER,,,,,,,2020,1.0
NCT04456153,,2020-06-30,2021-11-10,,2021-12-12,2020-06-30,2020-07-02,ACTUAL,2021-12-12,2021-12-14,ACTUAL,,,,2021-12-12,2021-12-14,ACTUAL,2020-07-22,ACTUAL,2020-07-22,2021-12,2021-12-31,2021-01-31,ACTUAL,2021-01-31,2021-01-31,ACTUAL,2021-01-31,,INTERVENTIONAL,,,Atovaquone for Treatment of COVID-19,Atovaquone for Treatment of COVID-19,COMPLETED,,PHASE2,60.0,ACTUAL,University of Texas Southwestern Medical Center,This study was not powered for clinical endpoints.,2.0,,,f,,,,,t,f,,,t,,,,,,NO,There is no specified plan made.,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,OTHER,,,,,,,2021,1.0
NCT04401527,,2020-05-21,,,2020-09-11,2020-05-21,2020-05-26,ACTUAL,,,,,,,2020-09-11,2020-09-16,ACTUAL,2020-07-22,ACTUAL,2020-07-22,2020-09,2020-09-30,2020-08-15,ACTUAL,2020-08-15,2020-08-15,ACTUAL,2020-08-15,,INTERVENTIONAL,,,Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite,"Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Study",WITHDRAWN,,PHASE2,0.0,ACTUAL,Hope Pharmaceuticals,,2.0,,No recruitment,f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,INDUSTRY,,,,,,,2020,0.0
NCT03646188,,2018-08-22,2022-01-26,,2024-02-14,2018-08-22,2018-08-24,ACTUAL,2022-03-30,2022-08-17,ACTUAL,,,,2024-02-14,2024-03-12,ACTUAL,2020-06-10,ACTUAL,2020-06-10,2024-02,2024-02-29,2021-05-04,ACTUAL,2021-05-04,2021-03-01,ACTUAL,2021-03-01,,INTERVENTIONAL,,,Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC),"An Open-Label Dose Escalation Trial to Evaluate Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), Safety, and Tolerability of Microneedle Arrays Containing Doxorubicin (D-MNA) in Participants With Basal Cell Carcinoma (BCC)",TERMINATED,,PHASE1,13.0,ACTUAL,"SkinJect, Inc.",,5.0,,Application of arrays was inconsistent.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:34:12.557604,2024-10-17 03:34:12.557604,INDUSTRY,,,,,,,2021,0.0
NCT05447663,,2022-06-28,,,2024-05-01,2022-07-06,2022-07-07,ACTUAL,,,,,,,2024-05-01,2024-05-03,ACTUAL,2023-02-23,ACTUAL,2023-02-23,2024-05,2024-05-31,2023-10-26,ACTUAL,2023-10-26,2023-10-26,ACTUAL,2023-10-26,,INTERVENTIONAL,,,A Study of Siremadlin Alone and in Combination With Donor Lymphocyte Infusion in Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplant,"A Phase Ib/II, Open Label Study of Siremadlin Monotherapy and in Combination With Donor Lymphocyte Infusion as a Treatment for Patients With Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplantation Who Are in Complete Remission But at High Risk for Relapse.",TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,Novartis,,1.0,,Study has been stopped following to strategic decision from the Sponsor. Not based on any safety findings or safety concerns with siremadlin.,f,,,,f,t,f,,,,,,,,https://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,INDUSTRY,,,,,,,2023,0.0
NCT04768478,,2021-02-22,,,2022-01-18,2021-02-23,2021-02-24,ACTUAL,,,,,,,2022-01-18,2022-01-28,ACTUAL,2021-10-01,ESTIMATED,2021-10-01,2022-01,2022-01-31,2023-12-31,ESTIMATED,2023-12-31,2023-10-01,ESTIMATED,2023-10-01,,INTERVENTIONAL,,,CBD for Pain Reduction and Opioid Use After Ankle and Tibia Fracture ORIF,"The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Ankle and Tibia Fracture Open Reduction and Internal Fixation. A Double-Blind, Randomized Control Study",WITHDRAWN,,PHASE4,0.0,ACTUAL,NYU Langone Health,,2.0,,there was no funding to begin the study,f,,,,f,t,f,,,,,,Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.,"The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Philipp.Leucht@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.",,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.",2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,OTHER,,,,,,,2023,0.0
NCT04156100,,2019-09-18,,,2022-02-15,2019-11-05,2019-11-07,ACTUAL,,,,,,,2022-02-15,2022-03-03,ACTUAL,2019-12-10,ACTUAL,2019-12-10,2022-02,2022-02-28,2021-09-29,ACTUAL,2021-09-29,2021-04-08,ACTUAL,2021-04-08,,INTERVENTIONAL,,,A Study in Subjects With Advanced Solid Tumors,"A Phase 1 Study of AGEN1223, a Bispecific Fc-Engineered Antibody as a Single Agent and in Combination With Balstilimab, an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,19.0,ACTUAL,Agenus Inc.,,2.0,,Strategic business decision.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,INDUSTRY,,,,,,,2021,0.0
NCT05190419,,2021-12-30,2023-11-22,,2024-03-19,2021-12-30,2022-01-13,ACTUAL,2024-03-19,2024-04-16,ACTUAL,,,,2024-03-19,2024-04-16,ACTUAL,2021-12-30,ACTUAL,2021-12-30,2024-03,2024-03-31,2022-12-20,ACTUAL,2022-12-20,2022-11-24,ACTUAL,2022-11-24,,INTERVENTIONAL,IASOS,The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.,Study to Assess the Efficacy and Safety of Orismilast in Psoriasis,"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of Orismilast in Adults With Moderate-to-Severe Plaque-Type Psoriasis",COMPLETED,,PHASE2,202.0,ACTUAL,UNION therapeutics,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,INDUSTRY,,,,,,,2022,1.0
NCT04985656,,2021-07-29,,,2021-09-23,2021-07-29,2021-08-02,ACTUAL,,,,,,,2021-09-23,2021-09-29,ACTUAL,2021-10-01,ESTIMATED,2021-10-01,2021-09,2021-09-30,2024-11-08,ESTIMATED,2024-11-08,2024-01-08,ESTIMATED,2024-01-08,,INTERVENTIONAL,PEVOBINE,,A Study of Pevonedistat Combined With Decitabine and Cedazuridine in Adults With Higher-risk Myelodysplastic Syndromes,"A Phase 2, Open-Label Study of Intravenous Pevonedistat in Combination With Oral Decitabine and Cedazuridine in Adult Patients With Higher-Risk Myelodysplastic Syndromes",WITHDRAWN,,PHASE2,0.0,ACTUAL,Takeda,,1.0,,Sponsor Decision to Terminate Trial,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,INDUSTRY,,,,,,,2024,0.0
NCT03606213,,2018-07-02,2022-10-20,2022-03-21,2023-05-26,2018-07-27,2018-07-30,ACTUAL,2023-05-26,2023-05-31,ACTUAL,,2023-05-31,ACTUAL,2023-05-26,2023-05-31,ACTUAL,2018-08-01,ACTUAL,2018-08-01,2023-05,2023-05-31,2021-05-17,ACTUAL,2021-05-17,2021-05-17,ACTUAL,2021-05-17,,INTERVENTIONAL,,,Therapeutic Vaccination in Treated HIV Disease,"Safety, Immunogenicty and Anti-Reservoir Activity of an Electroporation-Administered HIV DNA Vaccine Encoding GAG, POL and ENV Proteins With IL-12 Plasmid in HIV-Infected Adults on Antriretroviral Therapy.",COMPLETED,,PHASE1/PHASE2,56.0,ACTUAL,"University of California, San Francisco",,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,OTHER,,,,,,,2021,1.0
NCT04999020,,2021-08-04,,,2024-09-09,2021-08-04,2021-08-10,ACTUAL,,,,,,,2024-09-09,2024-09-19,ACTUAL,2021-11-19,ACTUAL,2021-11-19,2024-09,2024-09-30,2024-05-08,ACTUAL,2024-05-08,2023-10-26,ACTUAL,2023-10-26,,INTERVENTIONAL,,,Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis,"A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Dermatomyositis",TERMINATED,,PHASE2/PHASE3,38.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,2.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,YES,"Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.",2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,INDUSTRY,,,,,,,2024,0.0
NCT04315961,,2020-03-18,2024-06-03,,2024-07-16,2020-03-19,2020-03-20,ACTUAL,2024-07-16,2024-08-09,ACTUAL,,,,2024-07-16,2024-08-09,ACTUAL,2020-09-18,ACTUAL,2020-09-18,2024-07,2024-07-31,2023-02-02,ACTUAL,2023-02-02,2023-02-02,ACTUAL,2023-02-02,,INTERVENTIONAL,,"The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.",Effects of Dietary Conditions on Drug Response,Effects of Dietary Conditions on Drug Response,TERMINATED,,PHASE1,1.0,ACTUAL,Johns Hopkins University,Early termination - Study was terminated due to COVID 19 lockdown and subsequent research restrictions.,2.0,,Unable to recruit participants.,f,,,,f,t,f,,,t,,,,,,NO,There is not currently a plan to make individual participant data available to other researchers.,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,OTHER,,,,,,,2023,0.0
NCT03954938,,2019-05-15,2022-04-27,,2024-04-25,2019-05-15,2019-05-17,ACTUAL,2024-04-25,2024-05-23,ACTUAL,,,,2024-04-25,2024-05-23,ACTUAL,2019-05-15,ACTUAL,2019-05-15,2024-04,2024-04-30,2021-12-03,ACTUAL,2021-12-03,2021-12-03,ACTUAL,2021-12-03,,INTERVENTIONAL,,Completing subjects,Behavioral Effects of Drugs (Inpatient): 38,Influence of Craving Manipulation on Cocaine Self-Administration,TERMINATED,,EARLY_PHASE1,5.0,ACTUAL,University of Kentucky,Early termination leading to small numbers of subjects analyzed; only completing subjects' data analyzed due to within subjects design.,3.0,,COVID-19,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,OTHER,,,,,,,2021,0.0
NCT03238157,,2017-07-31,,,2021-08-02,2017-07-31,2017-08-03,ACTUAL,,,,,,,2021-08-02,2021-08-04,ACTUAL,2022-02-01,ESTIMATED,2022-02-01,2021-08,2021-08-31,2022-09-01,ESTIMATED,2022-09-01,2022-09-01,ESTIMATED,2022-09-01,,INTERVENTIONAL,,,Steroids for Early Treatment of Radiation Retinopathy,Steroids for Early Treatment of Radiation Retinopathy,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,The Cleveland Clinic,,2.0,,Lack of funding,,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,OTHER,,,,,,,2022,0.0
NCT03898973,,2019-03-30,,,2023-11-17,2019-03-30,2019-04-02,ACTUAL,,,,,,,2023-11-17,2023-11-21,ACTUAL,2019-04-11,ACTUAL,2019-04-11,2022-05,2022-05-31,2023-11-17,ACTUAL,2023-11-17,2023-11-17,ACTUAL,2023-11-17,,INTERVENTIONAL,FLU-LN,,Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood,Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood,WITHDRAWN,,PHASE4,0.0,ACTUAL,Stanford University,,1.0,,Were not able to enroll participants,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,OTHER,,,,,,,2023,0.0
NCT03636269,,2018-08-03,2021-09-21,2021-03-26,2022-03-29,2018-08-15,2018-08-17,ACTUAL,2022-03-29,2022-04-26,ACTUAL,2022-03-29,2022-04-26,ACTUAL,2022-03-29,2022-04-26,ACTUAL,2018-07-17,ACTUAL,2018-07-17,2022-03,2022-03-31,2020-03-30,ACTUAL,2020-03-30,2020-03-30,ACTUAL,2020-03-30,,INTERVENTIONAL,KALM-2,,CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus,"A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus, With a 52-Week Open Label Extension",COMPLETED,,PHASE3,473.0,ACTUAL,"Cara Therapeutics, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,INDUSTRY,,,,,,,2020,1.0
NCT03471286,,2018-03-02,,,2021-08-20,2018-03-19,2018-03-20,ACTUAL,,,,,,,2021-08-20,2021-08-26,ACTUAL,2019-06-06,ACTUAL,2019-06-06,2021-08,2021-08-31,2021-07-30,ACTUAL,2021-07-30,2021-07-30,ACTUAL,2021-07-30,,INTERVENTIONAL,,,A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies,A Phase 1b Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies,TERMINATED,,PHASE1,2.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,Deprioritization of drug in this patient population,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,OTHER,,,,,,,2021,0.0
NCT04829214,,2021-03-29,2022-10-18,,2022-12-13,2021-03-31,2021-04-02,ACTUAL,2022-12-13,2023-01-06,ACTUAL,,,,2022-12-13,2023-01-06,ACTUAL,2021-03-22,ACTUAL,2021-03-22,2022-12,2022-12-31,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,,OTO-313 in Subjects With Unilateral Subjective Tinnitus,"A Randomized, Double-blind, Placebo-controlled Phase 2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Unilateral Subjective Tinnitus",COMPLETED,,PHASE2,153.0,ACTUAL,"Otonomy, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,INDUSTRY,,,,,,,2022,1.0
NCT04250363,,2020-01-29,2022-12-08,,2023-11-07,2020-01-29,2020-01-31,ACTUAL,2023-11-07,2024-05-01,ACTUAL,,,,2023-11-07,2024-05-01,ACTUAL,2020-02-17,ACTUAL,2020-02-17,2023-11,2023-11-30,2021-08-18,ACTUAL,2021-08-18,2021-08-18,ACTUAL,2021-08-18,,INTERVENTIONAL,,"Safety analysis population (SAF) included all intent to treat (ITT) participants, who have been inoculated using a Direct Intravenous Inoculation (DVI) of PfSPZ and who were administered one dose of study intervention (M5717 or placebo). ITT population included all participants, who were randomized to study intervention.",Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model,"A Phase Ib, Randomized, Double-Blind, Placebo Controlled, Sequential Study of Single Oral Doses of M5717 to Explore the Chemoprophylactic Activity of M5717 in a Controlled PISPZ Challenge Model in Healthy Participants",COMPLETED,,PHASE1,39.0,ACTUAL,"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany",,10.0,,,f,,,,f,f,f,,,,,,,,,NO,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21",2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,INDUSTRY,,,,,,,2021,1.0
NCT04898309,,2021-05-18,,,2022-01-21,2021-05-21,2021-05-24,ACTUAL,,,,,,,2022-01-21,2022-02-04,ACTUAL,2021-12-01,ESTIMATED,2021-12-01,2022-01,2022-01-31,2023-05-31,ESTIMATED,2023-05-31,2023-05-31,ESTIMATED,2023-05-31,,INTERVENTIONAL,,,Efficacy and Safety of GNR-038 vs Berinert® in Patients With Hereditary Angioedema,A Placebo-controlled Randomized Trial to Evaluate the Efficacy and Safety of GNR-038 in Comparison With Berinert® for Acute Attacks Relief in Patients With Hereditary Angioedema,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,AO GENERIUM,,6.0,,Company pipeline revision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,INDUSTRY,,,,,,,2023,0.0
NCT03387579,,2017-12-03,2022-04-07,,2024-06-14,2017-12-22,2018-01-02,ACTUAL,2022-08-04,2022-08-26,ACTUAL,,,,2024-06-14,2024-06-18,ACTUAL,2018-11-30,ACTUAL,2018-11-30,2024-06,2024-06-30,2024-03-19,ACTUAL,2024-03-19,2021-03-28,ACTUAL,2021-03-28,,INTERVENTIONAL,,,Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates,Comparison of Composite Lipid Emulsion Containing Fish Oil to Soy-based Lipid Reduction for Cholestasis Prevention in Neonates Requiring Abdominal Surgery,COMPLETED,,PHASE3,24.0,ACTUAL,Indiana University,,3.0,,,,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,OTHER,,,,,,,2024,1.0
NCT04652765,,2020-12-02,2022-11-03,,2023-10-05,2020-12-02,2020-12-03,ACTUAL,2023-10-05,2023-10-06,ACTUAL,,,,2023-10-05,2023-10-06,ACTUAL,2021-02-03,ACTUAL,2021-02-03,2023-10,2023-10-31,2021-09-15,ACTUAL,2021-09-15,2021-09-15,ACTUAL,2021-09-15,,INTERVENTIONAL,COMBO,,Camostat With Bicalutamide for COVID-19,COMBO Trial: Camostat With Bicalutamide for COVID-19,TERMINATED,,PHASE1,6.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,3.0,,PI Decision to close/stop the study due to no new accrual.,,,,,,t,f,,,,,,,,,NO,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,OTHER,,,,,,,2021,0.0
NCT03630224,,2018-08-10,,,2024-01-29,2018-08-10,2018-08-14,ACTUAL,,,,,,,2024-01-29,2024-01-31,ACTUAL,2019-06-24,ACTUAL,2019-06-24,2024-01,2024-01-31,2023-08-18,ACTUAL,2023-08-18,2023-08-18,ACTUAL,2023-08-18,,INTERVENTIONAL,ASTRAU,,Plasmalyte Versus Saline in Trauma Patients,Renal Effects of Fluid Resuscitation With Plasmalyte Viaflo Versus Saline in Trauma Patients (the ASTRAU Study),TERMINATED,,PHASE3,365.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,Premature termination due to futility following interim analysis,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,OTHER,,,,,,,2023,0.0
NCT04987281,,2021-06-26,,,2023-12-28,2021-07-22,2021-08-03,ACTUAL,,,,,,,2023-12-28,2024-01-03,ACTUAL,2022-01-26,ACTUAL,2022-01-26,2023-12,2023-12-31,2023-12-27,ACTUAL,2023-12-27,2023-12-27,ACTUAL,2023-12-27,,INTERVENTIONAL,,,"Robotic Bronchoscopy With Cone CT and Indocyanine Green to Aid Removal of Lung Lesions in Patients With Stage I Non-small Cell Lung Cancer or Lung Metastases, REPLACING Study",Resection of Pulmonary Lesions Aided by Robotic Bronchoscopy With Cone CT and INdocyanin Green (REPLACING) Study,WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,0 ACTUAL Enrollment must have Overall Recruitment,f,,,,t,f,t,,,,,,,,,,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,OTHER,,,,,,,2023,0.0
NCT03303066,,2017-10-02,,,2023-05-01,2017-10-02,2017-10-05,ACTUAL,,,,,,,2023-05-01,2023-05-03,ACTUAL,2018-06-06,ACTUAL,2018-06-06,2023-04,2023-04-30,2023-02-08,ACTUAL,2023-02-08,2023-01-11,ACTUAL,2023-01-11,,INTERVENTIONAL,,,Efficacy and Safety of FG-4592 for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome (MDS),A Phase 2/3 Trial of FG-4592 for Treatment of Anemia in Subjects With Lower Risk Myelodysplastic Syndrome,COMPLETED,,PHASE2/PHASE3,43.0,ACTUAL,FibroGen,,3.0,,,f,,,,t,f,f,,,f,,,,,,,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,INDUSTRY,,,,,,,2023,1.0
NCT04128319,,2019-09-27,2021-06-21,,2021-12-07,2019-10-14,2019-10-16,ACTUAL,2021-07-12,2021-08-04,ACTUAL,,,,2021-12-07,2021-12-16,ACTUAL,2019-11-21,ACTUAL,2019-11-21,2021-12,2021-12-31,2020-02-17,ACTUAL,2020-02-17,2020-02-17,ACTUAL,2020-02-17,,INTERVENTIONAL,1802,,T-Guard as Treatment for Steroid Refractory Acute GVHD (BMT CTN 1802),"An Open-Label, Single-Arm, Multicenter Study, of Combination Anti-CD3/CD7 Immunotoxin (T-Guard) for Steroid-Refractory Acute Graft-versus-Host Disease)",TERMINATED,,PHASE3,3.0,ACTUAL,Xenikos,"Due to the early trial closure and limited study population, only a subset of the protocol-specified planned analyses were performed.",1.0,,Initiated a new randomized trial per discussion with FDA,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,INDUSTRY,,,,,,,2020,0.0
NCT02901431,,2016-09-12,2020-12-07,,2021-01-14,2016-09-12,2016-09-15,ESTIMATED,2021-01-14,2021-02-08,ACTUAL,,,,2021-01-14,2021-02-08,ACTUAL,2016-11-21,ACTUAL,2016-11-21,2021-01,2021-01-31,2020-06-30,ACTUAL,2020-06-30,2020-04-15,ACTUAL,2020-04-15,,INTERVENTIONAL,,"PK Part \& Main Part reported separately. 7 patients (re-starters) are counted twice. PK review revealed age-adjusted doses of 4 \& 10 mg in 5-17 year olds weren't equivalent to target exposure. For Main Study Part, data was summarised by exposure ranges (tertiles) based on individual patients PK exposure at Week 12, estimated as average plasma concentration since treatment start. To allow clear analysis by exposure tertiles, patients with dose adjustment were excluded from analysis by tertiles.",A Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Participants With Autism Spectrum Disorder (ASD),"A Phase II Multi-Center, Randomized, Double-Blind, 24-Week, Parallel Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Children and Adolescents Age 5-17 With Autism Spectrum Disorder (ASD)",TERMINATED,,PHASE2,339.0,ACTUAL,Hoffmann-La Roche,"Study was terminated early, therefore, there was limited data collected in Open Label Extension part of the study.",3.0,,The 24-week analysis indicated no clinical or statistical benefit for the primary endpoint for the overall study population. No new safety concerns identified.,f,,,,,,,,,,,,,,,,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,INDUSTRY,,,,,,,2020,0.0
NCT03829514,,2019-01-25,2021-09-08,2021-02-17,2023-10-05,2019-02-01,2019-02-04,ACTUAL,2022-01-11,2022-02-08,ACTUAL,2022-01-11,2022-02-08,ACTUAL,2023-10-05,2023-10-24,ACTUAL,2019-02-04,ACTUAL,2019-02-04,2023-10,2023-10-31,2020-03-04,ACTUAL,2020-03-04,2020-03-04,ACTUAL,2020-03-04,,INTERVENTIONAL,,,Fenofibrate in Type 2 Diabetes,Fenofibrate in Type 2 Diabetes- Novel Biomarkers and Mechanisms,COMPLETED,,PHASE4,10.0,ACTUAL,Medical University of South Carolina,,1.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,OTHER,,,,,,,2020,1.0
NCT03236805,,2017-07-17,,,2022-12-20,2017-07-28,2017-08-02,ACTUAL,,,,,,,2022-12-20,2022-12-21,ACTUAL,2017-11-23,ACTUAL,2017-11-23,2022-12,2022-12-31,2022-11-26,ACTUAL,2022-11-26,2022-11-26,ACTUAL,2022-11-26,,INTERVENTIONAL,KETAMORPH,,Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia,Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia a Randomized Controlled Trial,TERMINATED,,PHASE3,285.0,ACTUAL,Nantes University Hospital,,2.0,,285 patients have recruited instead on 496 but we don't want to continue to prolonge the study. Analysis will be performed on the data we have.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,OTHER,,,,,,,2022,0.0
NCT05169710,,2021-12-13,2024-08-23,,2024-09-18,2021-12-13,2021-12-27,ACTUAL,2024-08-23,2024-09-19,ACTUAL,,,,2024-09-18,2024-10-03,ACTUAL,2021-12-21,ACTUAL,2021-12-21,2024-09,2024-09-30,2023-10-18,ACTUAL,2023-10-18,2023-10-18,ACTUAL,2023-10-18,,INTERVENTIONAL,,,A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.,"A Multi-region, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)",TERMINATED,,PHASE3,83.0,ACTUAL,"Sumitomo Pharma America, Inc.",,3.0,,Company decided not to move forward with further accrual.,f,,,,t,t,f,,,,,,IPD will be made available upon request within 12 months of posting the study results on ct.gov.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",,YES,IPD for this study may be made available upon request via the Vivli Center for Global Clinical Research Data Site,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,INDUSTRY,,,,,,,2023,0.0
NCT04353661,,2020-04-14,,,2023-07-31,2020-04-16,2020-04-20,ACTUAL,,,,,,,2023-07-31,2023-08-02,ACTUAL,2021-11-16,ACTUAL,2021-11-16,2023-07,2023-07-31,2023-06-29,ACTUAL,2023-06-29,2023-06-29,ACTUAL,2023-06-29,,INTERVENTIONAL,,,A Study Of ¹²⁹XE MRI To Assess Disease Progression In Patients With COPD Treated With Or Without Azithromycin And Standard-of-Care Medications,¹²⁹XE MRI Assessment Of Disease Progression In Patients With Chronic Obstructive Pulmonary Disease Treated With Standard-of-Care Medications With Or Without Daily Open-Label Azithromycin Treatment To Prevent Acute Exacerbation,TERMINATED,,PHASE2,12.0,ACTUAL,"Genentech, Inc.",,3.0,,The study was terminated by Sponsor due to patient recruitment challenges.,f,,,,f,t,f,,,,,,,,,,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,INDUSTRY,,,,,,,2023,0.0
NCT03715829,,2018-10-19,2022-01-10,,2022-03-01,2018-10-19,2018-10-23,ACTUAL,2022-03-01,2022-03-25,ACTUAL,,,,2022-03-01,2022-03-25,ACTUAL,2018-11-26,ACTUAL,2018-11-26,2022-03,2022-03-31,2021-02-05,ACTUAL,2021-02-05,2021-02-05,ACTUAL,2021-02-05,,INTERVENTIONAL,,Baseline analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication).,A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects,"A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 WITH A PARTIALLY BLINDED EXTENSION PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH ACTIVE NON-SEGMENTAL VITILIGO",COMPLETED,,PHASE2,366.0,ACTUAL,Pfizer,,12.0,,,f,,,,,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,INDUSTRY,,,,,,,2021,1.0
NCT04757857,,2021-02-08,,,2023-01-20,2021-02-16,2021-02-17,ACTUAL,,,,,,,2023-01-20,2023-01-25,ACTUAL,2020-09-29,ACTUAL,2020-09-29,2023-01,2023-01-31,2022-08-30,ACTUAL,2022-08-30,2022-08-08,ACTUAL,2022-08-08,,INTERVENTIONAL,CARE,,COVID-19 Antithrombotic Rivaroxaban Evaluation,"Randomized, Pragmatic, Open Controlled Multicentre Study, Evaluating the Use of Rivaroxaban in Mild or Moderate COVID-19 Patients",TERMINATED,,PHASE4,660.0,ACTUAL,Hospital Alemão Oswaldo Cruz,,2.0,,Sustained reduction in the number of new COVID-19 cases as well as lower than expected event rates,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 03:40:15.942627,2024-10-17 03:40:15.942627,OTHER,,,,,,,2022,0.0
NCT03605342,,2018-06-29,2024-04-09,,2024-08-15,2018-07-20,2018-07-30,ACTUAL,2024-08-15,2024-08-19,ACTUAL,,,,2024-08-15,2024-08-19,ACTUAL,2018-10-01,ACTUAL,2018-10-01,2024-08,2024-08-31,2023-04-14,ACTUAL,2023-04-14,2023-04-14,ACTUAL,2023-04-14,,INTERVENTIONAL,,,Optimal Treatment of Veterans With PTSD and Comorbid OUD,Optimal Treatment of Veterans With PTSD and Comorbid Opiate Use Disorder (OUD),TERMINATED,,PHASE2,38.0,ACTUAL,VA Office of Research and Development,,2.0,,Early termination,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,FED,,,,,,,2023,0.0
NCT03301415,,2017-09-28,2022-11-29,,2022-12-29,2017-09-28,2017-10-04,ACTUAL,2022-12-29,2023-01-26,ACTUAL,,,,2022-12-29,2023-01-26,ACTUAL,2019-08-21,ACTUAL,2019-08-21,2018-10,2018-10-31,2020-11-05,ACTUAL,2020-11-05,2020-11-05,ACTUAL,2020-11-05,,INTERVENTIONAL,,,Asymptomatic Congenital CMV Treatment,"A Phase II, Single Stage, Single-Arm Investigation of Oral Valganciclovir Therapy in Infants With Asymptomatic Congenital Cytomegalovirus Infection",TERMINATED,,PHASE2,7.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),The trial was stopped early due to low accrual with only 7 participants enrolled.,1.0,,Safety signal,f,,,,,t,f,,,f,,,,,,,,2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,NIH,,,,,,,2020,0.0
NCT02052219,,2014-01-29,,,2015-07-28,2014-01-30,2014-02-03,ESTIMATED,,,,,,,2015-07-28,2015-07-30,ESTIMATED,2014-10,,2014-10-31,2015-07,2015-07-31,2021-10,ESTIMATED,2021-10-31,2016-10,ESTIMATED,2016-10-31,,INTERVENTIONAL,,,BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy,"A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy",WITHDRAWN,,PHASE3,0.0,ACTUAL,Anthera Pharmaceuticals,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,INDUSTRY,,,,,,,2021,0.0
NCT05126329,,2021-11-03,,,2022-09-09,2021-11-15,2021-11-19,ACTUAL,,,,,,,2022-09-09,2022-09-14,ACTUAL,2021-11-15,ACTUAL,2021-11-15,2022-09,2022-09-30,2022-05-16,ACTUAL,2022-05-16,2022-05-16,ACTUAL,2022-05-16,,INTERVENTIONAL,,,Pharmacokinetics of Amcenestrant in Female Hepatic Impaired Participants as Compared to Participants With Normal Hepatic Function,"An Open-label Pharmacokinetic and Tolerability Study of Amcenestrant Given as a Single Dose in Female Participants With Mild and Moderate Hepatic Impairment, and in Matched Participants With Normal Hepatic Function",TERMINATED,,PHASE1,13.0,ACTUAL,Sanofi,,3.0,,"Sponsor decision to prematurely stop the study, not linked to any safety concern",f,,,,f,f,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,INDUSTRY,,,,,,,2022,0.0
NCT04281472,,2020-02-20,2024-05-08,,2024-07-26,2020-02-21,2020-02-24,ACTUAL,2024-07-26,2024-08-20,ACTUAL,,,,2024-07-26,2024-08-20,ACTUAL,2020-04-15,ACTUAL,2020-04-15,2024-07,2024-07-31,2023-05-11,ACTUAL,2023-05-11,2023-05-11,ACTUAL,2023-05-11,,INTERVENTIONAL,ADHERE,"A total of 322 participants received efgartigimod PH20 SC in Stage A, and 221 of the 322 participants were randomized in a 1:1 ratio to efgartigimod PH20 SC (N=111) or placebo (N=110) in Stage B. Therefore, the total number of participants was 322, not 543 which was automatically calculated.","A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)","A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)",COMPLETED,,PHASE2,322.0,ACTUAL,argenx,,2.0,,,,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,INDUSTRY,,,,,,,2023,1.0
NCT04065841,,2019-08-19,2023-10-26,,2024-06-17,2019-08-20,2019-08-22,ACTUAL,2023-12-07,2023-12-26,ACTUAL,,,,2024-06-17,2024-06-20,ACTUAL,2019-12-30,ACTUAL,2019-12-30,2024-06,2024-06-30,2022-10-27,ACTUAL,2022-10-27,2022-10-27,ACTUAL,2022-10-27,,INTERVENTIONAL,ELIVATE,Full Analysis Set (FAS): all participants to whom study treatment was assigned by randomization and were treated,"Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.","A Randomized, Double-blind, Parallel-group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Oral Tropifexor (LJN452) & Licogliflozin (LIK066) Combination Therapy and Each Monotherapy, Compared With Placebo for Treatment of Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis.(ELIVATE)",TERMINATED,,PHASE2,234.0,ACTUAL,Novartis,,4.0,,The sponsor made a business decision to stop development of the trial drugs. The decision to stop the trial early was not because of any safety concerns.,f,,,,t,t,f,,,,,,,,,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,INDUSTRY,,,,,,,2022,0.0
NCT02598999,,2015-11-04,,,2022-01-20,2015-11-05,2015-11-06,ESTIMATED,,,,,,,2022-01-20,2022-02-03,ACTUAL,2015-11,ACTUAL,2015-11-30,2022-01,2022-01-31,2021-12,ACTUAL,2021-12-31,2021-12,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients,"Randomized, Double Blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics After Single Ascending Doses or Multiple Ascending Doses of OSCN-, bLF or ALX-009 in Healthy Male and CF and Non-CF Bronchiectasis Patients",TERMINATED,,PHASE1,92.0,ACTUAL,Alaxia SAS,,4.0,,Financial issues,f,,,,f,,,,,,,,,,,,,2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,INDUSTRY,,,,,,,2021,0.0
NCT04349371,,2020-04-12,2022-02-11,,2024-07-19,2020-04-15,2020-04-16,ACTUAL,2024-07-19,2024-08-13,ACTUAL,,,,2024-07-19,2024-08-13,ACTUAL,2020-04-21,ACTUAL,2020-04-21,2024-07,2024-07-31,2021-02-11,ACTUAL,2021-02-11,2021-02-11,ACTUAL,2021-02-11,,INTERVENTIONAL,,The study was terminated before participants could be assigned to any Arm.,Saved From COVID-19 - Chloroquine (CQ) Prophylaxis for Health Care Workers at Risk for COVID,Chloroquine (CQ) Prophylaxis for Health Care Workers at Risk for COVID,TERMINATED,,PHASE2,8.0,ACTUAL,Columbia University,Study was stopped early due to poor enrollment. Data was not collected and therefore not analyzed.,2.0,,Low enrollment.,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,OTHER,,,,,,,2021,0.0
NCT02940223,,2016-10-19,2021-05-14,,2021-05-14,2016-10-19,2016-10-20,ESTIMATED,2021-05-14,2021-06-10,ACTUAL,,,,2021-05-14,2021-06-10,ACTUAL,2017-03-16,ACTUAL,2017-03-16,2021-05,2021-05-31,2020-11-24,ACTUAL,2020-11-24,2020-11-24,ACTUAL,2020-11-24,,INTERVENTIONAL,,A total of 2 participants were recruited before the study was aborted due to low accrual.,Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer,Effects of Fish Oil and Physical Activity on Fatigue in Patients With Advanced Cancer,TERMINATED,,PHASE2,2.0,ACTUAL,M.D. Anderson Cancer Center,,3.0,,PI is requesting termination (closure) of this study.,f,,,,f,t,f,,,f,,,,,,,,2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,OTHER,,,,,,,2020,0.0
NCT05081271,,2021-10-14,,,2022-11-16,2021-10-14,2021-10-18,ACTUAL,,,,,,,2022-11-16,2022-11-21,ACTUAL,2021-10-15,ACTUAL,2021-10-15,2022-11,2022-11-30,2022-05-30,ACTUAL,2022-05-30,2022-05-30,ACTUAL,2022-05-30,,INTERVENTIONAL,,,COVID-19 Booster Vaccination in Persons With Multiple Sclerosis,COVID-19 Booster Vaccination in Persons With Multiple Sclerosis,TERMINATED,,EARLY_PHASE1,10.0,ACTUAL,Griffin Hospital,,2.0,,Most potential participants had already received their booster vaccinations outside of the study,f,,,,f,t,f,,,,,,IPD will be shared upon request following publication of our findings.,The study PI will review and address requests for IPD.,,YES,De-identified requests for IPD that underlie results in a publication will be made available to other researchers upon requests sent to the study PI.,2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,OTHER,,,,,,,2022,0.0
NCT06085638,,2023-10-10,,,2024-03-06,2023-10-10,2023-10-17,ACTUAL,,,,,,,2024-03-06,2024-03-07,ACTUAL,2023-09-14,ACTUAL,2023-09-14,2024-03,2024-03-31,2023-10-20,ACTUAL,2023-10-20,2023-10-20,ACTUAL,2023-10-20,,INTERVENTIONAL,,,Phase I/II Study of SY-1425 (Tamibarotene) in Combination With Azacitidine and Venetoclax for Patients With Chronic Myelomonocytic Leukemia,Phase I/II Study of SY-1425 (Tamibarotene) in Combination With Azacitidine and Venetoclax for Patients With Chronic Myelomonocytic Leukemia,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,Zero participants accrued,,,,,t,t,f,,,,,,,,,,,2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,OTHER,,,,,,,2023,0.0
NCT02890368,,2016-08-26,,,2023-03-31,2016-08-31,2016-09-07,ESTIMATED,,,,,,,2023-03-31,2023-04-05,ACTUAL,2016-09,,2016-09-30,2023-03,2023-03-31,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,,Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides,A Phase 1 Dose Escalation Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Percutaneously-Accessible Solid Tumors and Mycosis Fungoides,TERMINATED,,PHASE1,56.0,ACTUAL,Pfizer,,7.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,INDUSTRY,,,,,,,2020,0.0
NCT03721965,,2018-10-25,2022-12-21,2021-02-17,2023-01-24,2018-10-25,2018-10-26,ACTUAL,2023-01-24,2023-02-21,ACTUAL,2023-01-24,2023-02-21,ACTUAL,2023-01-24,2023-02-21,ACTUAL,2019-12-31,ACTUAL,2019-12-31,2023-01,2023-01-31,2020-02-17,ACTUAL,2020-02-17,2020-02-17,ACTUAL,2020-02-17,,INTERVENTIONAL,,,Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects,"An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Pediatric Subjects",TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,Incyte Corporation,,1.0,,The study was terminated due to insufficient efficacy in a separate phase III study,t,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,INDUSTRY,,NCT03906318,NO_LONGER_AVAILABLE,,,,2020,0.0
NCT04493242,,2020-07-29,2023-02-13,,2024-02-09,2020-07-29,2020-07-30,ACTUAL,2023-04-10,2023-04-11,ACTUAL,,,,2024-02-09,2024-02-13,ACTUAL,2020-09-24,ACTUAL,2020-09-24,2024-02,2024-02-29,2021-05-22,ACTUAL,2021-05-22,2021-05-01,ACTUAL,2021-05-01,,INTERVENTIONAL,EXIT-COVID19,The Safety Analysis Set consisted of all participants who received any study drug.,Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS,Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS): A Phase II Clinical Trial,COMPLETED,,PHASE2,102.0,ACTUAL,"Direct Biologics, LLC",,3.0,,,t,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,INDUSTRY,,NCT04657458,AVAILABLE,,,,2021,1.0
NCT03283631,,2017-09-13,,,2021-04-01,2017-09-13,2017-09-14,ACTUAL,,,,,,,2021-04-01,2021-04-05,ACTUAL,2018-05-30,ACTUAL,2018-05-30,2021-04,2021-04-30,2020-06-30,ACTUAL,2020-06-30,2019-09-19,ACTUAL,2019-09-19,,INTERVENTIONAL,INTERCEPT,,Intracerebral EGFR-vIII CAR-T Cells for Recurrent GBM,INTERCEPT: INTracerebral EGFR-vIII Chimeric Antigen Receptor Gene-Modified T CElls for PaTients With Recurrent GBM,TERMINATED,,PHASE1,2.0,ACTUAL,Duke University,,1.0,,We are halting enrollment of this study.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,OTHER,,,,,,,2020,0.0
NCT04866069,,2021-04-26,,,2023-04-17,2021-04-26,2021-04-29,ACTUAL,,,,,,,2023-04-17,2023-04-18,ACTUAL,2021-04-25,ACTUAL,2021-04-25,2023-04,2023-04-30,2021-09-05,ACTUAL,2021-09-05,2021-09-05,ACTUAL,2021-09-05,,INTERVENTIONAL,COVID-19,,Study of a Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Adjuvanted Inactivated Vaccine in Healthy Adults,"Phase I Study Evaluating the Safety and Efficacy of the Protective Adjuvanted Inactivated Vaccine Developed Against SARS-CoV-2 in Healthy Participants, Administered as Two Injections Subcutaneously in Two Different Dosages.",TERMINATED,,PHASE1,50.0,ACTUAL,The Scientific and Technological Research Council of Turkey,,3.0,,"Although cellular responses to virus were satisfactory, neutralizing titres against virus were lower then expected levels",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,OTHER,,,,,,,2021,0.0
NCT04823052,,2021-03-24,,,2022-12-07,2021-03-26,2021-03-30,ACTUAL,,,,,,,2022-12-07,2022-12-08,ACTUAL,2022-05-25,ACTUAL,2022-05-25,2022-12,2022-12-31,2022-10-19,ACTUAL,2022-10-19,2022-10-19,ACTUAL,2022-10-19,,INTERVENTIONAL,IMPACT-FXS,,Investigation of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) in Male Fragile X Syndrome Patients Aged 13-40,"A Phase 2, Placebo-controlled, Adaptive Design Study to Explore the Safety and Efficacy of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) and Possible Other Treatments in Adolescent and Adult Males With Fragile X Syndrome (FXS)",WITHDRAWN,,PHASE2,0.0,ACTUAL,Healx Limited,,4.0,,Healx has experienced delays to the site activation of the study and this has had an adverse impact on the recruitment timeline which is delaying the progress of other projects in our FXS programme.,f,,,,t,t,f,,,,,,,,,,,2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,INDUSTRY,,,,,,,2022,0.0
NCT03345810,,2017-11-14,,,2023-06-13,2017-11-14,2017-11-17,ACTUAL,,,,,,,2023-06-13,2023-06-15,ACTUAL,2017-12-14,ACTUAL,2017-12-14,2023-06,2023-06-30,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,DURATION,,Durvalumab (MEDI4736) in Frail and Elder Patients With Metastatic NSCLC (DURATION),Durvalumab (MEDI4736) in Frail and Elder Patients With Metastatic NSCLC (DURATION),COMPLETED,,PHASE2,200.0,ACTUAL,AIO-Studien-gGmbH,,4.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,OTHER,,,,,,,2022,1.0
NCT02431663,,2015-04-03,,,2020-10-05,2015-04-27,2015-05-01,ESTIMATED,,,,,,,2020-10-05,2020-10-08,ACTUAL,2015-04,,2015-04-30,2020-10,2020-10-31,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,KETASER01,,Ketamine in Refractory Convulsive Status Epilepticus,"Efficacy of Ketamine in Refractory Convulsive Status Epilepticus in Children: a Multicenter, Randomized, Controlled, Open-label, No-profit, With Sequential Design Study.",TERMINATED,,PHASE3,57.0,ACTUAL,Meyer Children's Hospital IRCCS,,2.0,,Futility,f,,,,f,,,,,,,,,,,,,2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,OTHER,,,,,,,2020,0.0
NCT04415151,,2020-06-02,,2021-12-29,2022-08-26,2020-06-02,2020-06-04,ACTUAL,,,,2021-12-29,2022-01-03,ACTUAL,2022-08-26,2022-08-31,ACTUAL,2020-10-14,ACTUAL,2020-10-14,2022-08,2022-08-31,2021-02-28,ACTUAL,2021-02-28,2021-02-28,ACTUAL,2021-02-28,,INTERVENTIONAL,I-TOMIC,,Tofacitinib for Treatment of Moderate COVID-19,Investigation of Tofacitinib to Mitigate the Impact of COVID-19 (I-TOMIC) in Moderate SARS-CoV-2 (MODERATE I-TOMIC),TERMINATED,,PHASE2,24.0,ACTUAL,Yale University,,2.0,,Study terminated due to lack of enrollment reflecting the decrease in number of COVID infections. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,OTHER,,,,,,,2021,0.0
NCT01963832,,2013-10-11,,,2015-01-09,2013-10-15,2013-10-16,ESTIMATED,,,,,,,2015-01-09,2015-01-12,ESTIMATED,2016-11,,2016-11-30,2014-12,2014-12-31,2021-11,ESTIMATED,2021-11-30,2020-11,ESTIMATED,2020-11-30,,INTERVENTIONAL,,,RCT of a Neuroplasticity Agent and CI Therapy for Severe Arm Paresis After Stroke,RCT of a Neuroplasticity Agent and CI Therapy for Severe Arm Paresis After Stroke,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Alabama at Birmingham,,4.0,,not funded,f,,,,t,,,,,,,,,,,,,2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,OTHER,,,,,,,2021,0.0
NCT03959241,,2019-05-20,2023-09-18,,2024-04-02,2019-05-21,2019-05-22,ACTUAL,2024-01-10,2024-01-12,ACTUAL,,,,2024-04-02,2024-04-04,ACTUAL,2019-06-25,ACTUAL,2019-06-25,2024-04,2024-04-30,2022-09-19,ACTUAL,2022-09-19,2022-09-19,ACTUAL,2022-09-19,,INTERVENTIONAL,1703/1801,Baseline Analysis Population includes all randomized participants.,TAC/MTX vs. TAC/MMF/PTCY for Prevention of Graft-versus-Host Disease and Microbiome and Immune Reconstitution Study (BMT CTN 1703/1801),"A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 1703; Progress III); Companion Study: Microbiome and Immune Reconstitution in Cellular Therapies and Hematopoietic Stem Cell Transplantation (BMT CTN 1801; Mi-Immune)",COMPLETED,,PHASE3,431.0,ACTUAL,Medical College of Wisconsin,,2.0,,,f,,,,t,t,f,,,f,,,Within 6 months of official study closure at participating sites.,Available to the public,https://biolincc.nhlbi.nih.gov/home/,YES,"Results will be published in a manuscript and supporting information submitted to NIH BioLINCC (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc where indicated).",2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,OTHER,,,,,,,2022,1.0
NCT04798989,,2021-03-11,,2023-10-17,2024-08-13,2021-03-11,2021-03-16,ACTUAL,,,,,2023-10-23,ACTUAL,2024-08-13,2024-08-15,ACTUAL,2021-06-01,ACTUAL,2021-06-01,2024-08,2024-08-31,2022-11-28,ACTUAL,2022-11-28,2022-11-28,ACTUAL,2022-11-28,,INTERVENTIONAL,,,A Study of the Effects of CY6463 in Participants With Alzheimer's Disease With Vascular Pathology,"A Phase 2a Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CY6463 When Administered to Participants With Alzheimer's Disease and Vascular Pathology",TERMINATED,,PHASE2,12.0,ACTUAL,Tisento Therapeutics,,2.0,,Due to enrollment challenges,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,INDUSTRY,,,,,,,2022,0.0
NCT04642079,,2020-11-18,2023-04-04,,2024-01-17,2020-11-18,2020-11-24,ACTUAL,2023-04-04,2023-04-26,ACTUAL,,,,2024-01-17,2024-01-22,ACTUAL,2020-12-04,ACTUAL,2020-12-04,2024-01,2024-01-31,2022-04-06,ACTUAL,2022-04-06,2022-04-06,ACTUAL,2022-04-06,,INTERVENTIONAL,,Enrolled population included all participants who signed informed consent form (ICF).,Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age,"A PHASE 3, SINGLE-ARM TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHILDREN 15 MONTHS THROUGH 17 YEARS OF AGE",COMPLETED,,PHASE3,839.0,ACTUAL,Pfizer,,4.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,INDUSTRY,,,,,,,2022,1.0
NCT02955524,,2016-11-02,,,2018-04-18,2016-11-03,2016-11-04,ESTIMATED,,,,,,,2018-04-18,2018-04-20,ACTUAL,2018-03,ESTIMATED,2018-03-31,2018-04,2018-04-30,2020-12,ESTIMATED,2020-12-31,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,TOPIAC,,Topical Anesthesia and Intra-arterial Chemotherapy for Retinoblastoma,Topical Anesthesia to Decrease the Trigeminal-Cardiac Reflex During Intra-arterial Injection of Chemotherapy for Retinoblastoma in Children.,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Miami,,1.0,,I discontinued this study because I transferred to another institution.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,OTHER,,,,,,,2020,0.0
NCT01490580,,2011-12-08,2018-07-16,,2021-02-10,2011-12-09,2011-12-13,ESTIMATED,2019-08-08,2019-09-13,ACTUAL,,,,2021-02-10,2021-03-04,ACTUAL,2012-05,ACTUAL,2012-05-31,2021-02,2021-02-28,2020-04-15,ACTUAL,2020-04-15,2016-08,ACTUAL,2016-08-31,,INTERVENTIONAL,PRETTINEO,,Premedication Trial for Tracheal Intubation of the NEOnate,Double Blind Randomized Controlled Trial Comparing Atropine+Propofol Versus Atropine+Atracurium+Sufentanil as a Premedication Prior to Semi-urgent or Elective Endotracheal Intubation of Term and Preterm Newborns,COMPLETED,,PHASE2/PHASE3,173.0,ACTUAL,Centre Hospitalier Intercommunal Creteil,,2.0,,,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,OTHER,,,,,,,2020,1.0
NCT03072771,,2017-03-02,,,2023-11-27,2017-03-02,2017-03-07,ACTUAL,,,,,,,2023-11-27,2023-11-28,ACTUAL,2017-08-01,ACTUAL,2017-08-01,2023-11,2023-11-30,2023-10-30,ACTUAL,2023-10-30,2021-04-07,ACTUAL,2021-04-07,,INTERVENTIONAL,,,Blinatumomab Consolidation Post Autologous Stem Cell Transplantation in Patients With Diffuse Large B-Cell Lymphoma (DLBCL),A Pilot Trial of Blinatumomab Consolidation Post Autologous Stem Cell Transplantation in Patients With DLBCL,COMPLETED,,PHASE1,14.0,ACTUAL,Washington University School of Medicine,,1.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,OTHER,,,,,,,2023,1.0
NCT04504916,,2020-08-04,2024-06-06,,2024-07-19,2020-08-06,2020-08-07,ACTUAL,2024-07-19,2024-08-15,ACTUAL,,,,2024-07-19,2024-08-15,ACTUAL,2020-10-07,ACTUAL,2020-10-07,2024-07,2024-07-31,2023-06-12,ACTUAL,2023-06-12,2023-06-12,ACTUAL,2023-06-12,,INTERVENTIONAL,,,A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002),A Phase 2 Study of VLS-101 in Patients With Solid Tumors,TERMINATED,,PHASE2,102.0,ACTUAL,"VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)",Study terminated due to business reasons,1.0,,Business reasons,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd,2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,INDUSTRY,,,,,,,2023,0.0
NCT03829878,,2019-01-28,,,2021-04-05,2019-02-01,2019-02-04,ACTUAL,,,,,,,2021-04-05,2021-04-08,ACTUAL,2020-05,ESTIMATED,2020-05-31,2021-04,2021-04-30,2021-12,ESTIMATED,2021-12-31,2020-05,ESTIMATED,2020-05-31,,INTERVENTIONAL,SPROUT,,"Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Autism Spectrum Disorder and Associated GI Symptoms (SPROUT)",A Randomized Double-Blind Placebo Controlled Cross-Over Study of CP101 (Full-Spectrum Microbiota®) in Children With Autism Spectrum Disorder and Associated Gastrointestinal Symptoms,WITHDRAWN,,PHASE2,0.0,ACTUAL,Finch Research and Development LLC.,,2.0,,Study not started,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,INDUSTRY,,,,,,,2021,0.0
NCT04803123,,2021-03-15,,,2023-12-18,2021-03-15,2021-03-17,ACTUAL,,,,,,,2023-12-18,2023-12-21,ACTUAL,2021-06-21,ACTUAL,2021-06-21,2023-12,2023-12-31,2023-04-26,ACTUAL,2023-04-26,2023-04-03,ACTUAL,2023-04-03,,INTERVENTIONAL,,,Window Trial to Evaluate Molecular Response to PI3K Inhibition With Copanlisib in r/r Adult B-cell ALL,Window Trial to Evaluate Molecular Response to PI3K Inhibition With Copanlisib in Relapsed or Refractory Adult B-cell Acute Lymphoblastic Leukemia,TERMINATED,,EARLY_PHASE1,3.0,ACTUAL,Duke University,,1.0,,Sponsor halted clinical development of study drug,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,OTHER,,,,,,,2023,0.0
NCT02288377,,2014-09-23,2021-08-11,,2022-12-21,2014-11-10,2014-11-11,ESTIMATED,2021-09-07,2021-10-04,ACTUAL,,,,2022-12-21,2023-01-18,ACTUAL,2015-01,ACTUAL,2015-01-31,2022-12,2022-12-31,2020-01,ACTUAL,2020-01-31,2020-01,ACTUAL,2020-01-31,,INTERVENTIONAL,REMINET,"Baseline population is the Intent-to-treat population, all the patients randomized.",A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET),"A EUROPEAN, MULTICENTRE, PHASE II/III RANDOMISED DOUBLE-BLIND, PLACEBO CONTROLLED STUDY EVALUATING LANREOTIDE AS MAINTENANCE THERAPY IN PATIENTS WITH NON-RESECTABLE DUODENO-PANCREATIC NEUROENDOCRINE TUMOURS AFTER FIRST-LINE TREATMENT",TERMINATED,,PHASE2/PHASE3,53.0,ACTUAL,Federation Francophone de Cancerologie Digestive,,2.0,,Because of slow recruitment,f,,,,t,,,,,,,,,,,,,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,OTHER,,,,,,,2020,0.0
NCT03716570,,2018-10-22,,,2021-05-21,2018-10-22,2018-10-23,ACTUAL,,,,,,,2021-05-21,2021-05-25,ACTUAL,2019-03-12,ACTUAL,2019-03-12,2021-05,2021-05-31,2021-04-23,ACTUAL,2021-04-23,2021-04-23,ACTUAL,2021-04-23,,INTERVENTIONAL,,,"A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's Disease","A Multicenter, Blinded, Placebo-Controlled, Randomized, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Subjects With Parkinson's Disease",TERMINATED,,PHASE1,24.0,ACTUAL,Biogen,,4.0,,Affiliated study NCT03318523 did not meet its primary outcome measure of change from baseline measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and did not demonstrate efficacy on secondary outcome measures,f,,,,f,t,f,,,t,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,INDUSTRY,,,,,,,2021,0.0
NCT03963401,,2019-05-15,2021-06-18,2020-11-12,2021-08-02,2019-05-23,2019-05-24,ACTUAL,2021-08-02,2021-08-04,ACTUAL,2021-08-02,2021-08-04,ACTUAL,2021-08-02,2021-08-04,ACTUAL,2019-06-13,ACTUAL,2019-06-13,2021-08,2021-08-31,2021-01-15,ACTUAL,2021-01-15,2020-04-06,ACTUAL,2020-04-06,,INTERVENTIONAL,,Baseline analysis population included all participants who were randomized to the study and received at least one dose of the randomized study treatment.,A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis,"A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF PF-06700841 TO EVALUATE THE EFFICACY AT 16 WEEKS AND TO EVALUATE THE SAFETY AND EFFICACY UP TO 1 YEAR IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS",COMPLETED,,PHASE2,219.0,ACTUAL,Pfizer,,6.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,INDUSTRY,,,,,,,2021,1.0
NCT05297864,,2022-03-09,,,2024-03-22,2022-03-25,2022-03-28,ACTUAL,,,,,,,2024-03-22,2024-03-26,ACTUAL,2022-06-09,ACTUAL,2022-06-09,2024-03,2024-03-31,2024-02-06,ACTUAL,2024-02-06,2023-11-14,ACTUAL,2023-11-14,,INTERVENTIONAL,OU-SCC-PI-4G,,PARP Inhibition for Gliomas (PI-4G or π4g),Phase II Trial of Niraparib in Patients With Recurrent Glioma,TERMINATED,,PHASE2,15.0,ACTUAL,University of Oklahoma,,1.0,,Funder terminated funding.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,OTHER,,,,,,,2024,0.0
NCT03908944,,2019-03-29,,,2020-06-10,2019-04-07,2019-04-09,ACTUAL,,,,,,,2020-06-10,2020-06-12,ACTUAL,2019-01-02,ACTUAL,2019-01-02,2020-06,2020-06-30,2022-01-02,ESTIMATED,2022-01-02,2021-01-02,ESTIMATED,2021-01-02,,INTERVENTIONAL,,,Postoperative Pain and Headache After Craniotomy,Postoperative Pain and Headache After Craniotomy,WITHDRAWN,,PHASE2,0.0,ACTUAL,Loyola University,,2.0,,PI- Dr. Jellish passed away. The study was terminated with the IRB,f,,,,f,t,f,,,t,,,,,,NO,No plan to share individual Data.,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,OTHER,,,,,,,2022,0.0
NCT04584697,,2020-10-07,,,2021-02-09,2020-10-09,2020-10-14,ACTUAL,,,,,,,2021-02-09,2021-02-12,ACTUAL,2020-12,ESTIMATED,2020-12-31,2021-02,2021-02-28,2021-04,ESTIMATED,2021-04-30,2021-04,ESTIMATED,2021-04-30,,INTERVENTIONAL,,,"Study to Evaluate the Safety, Pharmacokinetics and Efficacy of STI-2020 (COVI-AMG™) in Outpatients With COVID-19","A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Outpatients With COVID-19 Who Are Asymptomatic or Have Mild Symptoms",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,2.0,,Different study will be conducted,f,,,,,t,f,,,f,,,,,,,,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,INDUSTRY,,,,,,,2021,0.0
NCT03935399,,2019-04-24,2021-02-12,,2021-03-09,2019-04-29,2019-05-02,ACTUAL,2021-03-09,2021-04-05,ACTUAL,,,,2021-03-09,2021-04-05,ACTUAL,2019-08-08,ACTUAL,2019-08-08,2021-03,2021-03-31,2020-04-30,ACTUAL,2020-04-30,2020-03-15,ACTUAL,2020-03-15,,INTERVENTIONAL,,,Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin,Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin,COMPLETED,,PHASE4,10.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,OTHER,,,,,,,2020,1.0
NCT02402842,,2014-11-27,,,2022-05-10,2015-03-25,2015-03-30,ESTIMATED,,,,,,,2022-05-10,2022-05-16,ACTUAL,2014-09,,2014-09-30,2022-05,2022-05-31,2020-06-30,ACTUAL,2020-06-30,2018-06,ACTUAL,2018-06-30,,INTERVENTIONAL,Epitopes-HPV02,,Clinical and Biological Interest of Taxanes in Advanced Squamous Cell Anal Carcinoma,"Assessment of the Clinical Value of a Docetaxel, Cisplatin and 5-fluorouracil (DCF) Strategy Adapted to Patients for the Management of Metastatic or Locally Advanced Anal Resistant Radiochemotherapy Squamous Cell Anal Carcinoma.",COMPLETED,,PHASE2,70.0,ACTUAL,Centre Hospitalier Universitaire de Besancon,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,OTHER,,,,,,,2020,1.0
NCT04010539,,2019-07-02,2024-05-01,,2024-05-01,2019-07-05,2019-07-08,ACTUAL,2024-05-01,2024-05-30,ACTUAL,,,,2024-05-01,2024-05-30,ACTUAL,2019-10-21,ACTUAL,2019-10-21,2024-04,2024-04-30,2023-10-10,ACTUAL,2023-10-10,2023-10-10,ACTUAL,2023-10-10,,INTERVENTIONAL,,,A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea,"A Phase III, Randomized, Multicenter, Open-Label Study in Adolescent and Adult Participants Comparing the Efficacy and Safety of Gepotidacin to Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae",COMPLETED,,PHASE3,628.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,f,t,f,,,,,,"Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://www.gsk.com/en-gb/innovation/trials/data-transparency/,YES,Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,INDUSTRY,,,,,,,2023,1.0
NCT05407766,,2022-05-09,,,2022-12-21,2022-06-02,2022-06-07,ACTUAL,,,,,,,2022-12-21,2022-12-23,ACTUAL,2022-08,ESTIMATED,2022-08-31,2022-12,2022-12-31,2024-08,ESTIMATED,2024-08-31,2024-04,ESTIMATED,2024-04-30,,INTERVENTIONAL,,,Mesenchymal Stem Cells (MSCs) for Perianal Fistula,A Phase I Safety Study of Allogeneic Bone Marrow Derived MSCs for Refractory Perianal Fistulizing Crohn's Disease,WITHDRAWN,,PHASE1,0.0,ACTUAL,"Ossium Health, Inc.",,3.0,,OSSM-001 will not be used in this clinical program.,f,,,,t,t,f,,,,,,,,,,,2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,INDUSTRY,,,,,,,2024,0.0
NCT03610100,,2016-09-27,,,2019-10-27,2018-07-25,2018-08-01,ACTUAL,,,,,,,2019-10-27,2019-10-29,ACTUAL,2015-12,,2015-12-31,2019-05,2019-05-31,2022-12,ESTIMATED,2022-12-31,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,ACELARATE,,Acelarin First Line Randomised Pancreatic Study,"A Phase III, Open Label, Multicentre Randomised Clinical Study Comparing Acelarin (NUC-1031) With Gemcitabine in Patients With Metastatic Pancreatic Carcinoma",SUSPENDED,,PHASE2/PHASE3,328.0,ESTIMATED,The Clatterbridge Cancer Centre NHS Foundation Trust,,2.0,,Suspended to recruitment following TSC review on efficacy and toxicities,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,OTHER,,,,,,,2022,0.0
NCT03993613,,2019-05-29,,,2022-08-11,2019-06-19,2019-06-20,ACTUAL,,,,,,,2022-08-11,2022-08-15,ACTUAL,2019-03-21,ACTUAL,2019-03-21,2022-08,2022-08-31,2022-03-31,ACTUAL,2022-03-31,2022-03-31,ACTUAL,2022-03-31,,INTERVENTIONAL,,,Apotransferrin in Patients With β-thalassemia,Efficacy and Safety of Human Apotransferrin in Patients With β-thalassemia Intermedia,TERMINATED,,PHASE2,10.0,ACTUAL,Prothya Biosolutions,,1.0,,no availability of IMP for this study,f,,,,f,f,f,,,,,,,,,,,2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,INDUSTRY,,,,,,,2022,0.0
NCT04353037,,2020-04-09,2021-07-22,,2021-10-15,2020-04-15,2020-04-20,ACTUAL,2021-10-15,2021-10-19,ACTUAL,,,,2021-10-15,2021-10-19,ACTUAL,2020-04-07,ACTUAL,2020-04-07,2021-10,2021-10-31,2020-07-11,ACTUAL,2020-07-11,2020-07-11,ACTUAL,2020-07-11,,INTERVENTIONAL,,All eligible randomized patients,PATCH 2&3:Prevention & Treatment of COVID-19 (Severe Acute Respiratory Syndrome Coronavirus 2) With Hydroxychloroquine,PATCH 2 & 3: (Prevention and Treatment of COVID-19 With Hydroxychloroquine) A Double-blind Placebo Controlled Randomized Trial of Hydroxychloroquine in the Prevention and Treatment of COVID-19,TERMINATED,,PHASE2,39.0,ACTUAL,UnitedHealth Group,"No healthcare workers had a positive Covid test during the study period so the outcome for missed shifts due a positive Covid result was not measured.~Due to low enrollment numbers, only a descriptive analysis was reported and we did not test any of the hypotheses described in the statistical analysis plan.",2.0,,As enrollment began external studies called into question the safety and efficacy of hydroxychloroquine as a treatment which resulted in controversy. The timing of the controversy significantly impacted our ability to enroll and retain participants.,f,,,,t,t,f,,,f,,,1 year,,,YES,Data will be collected and managed by Optumcare and UnitedHealth Group Research \& Development. Redacted/aggregate data will be shared with the University Of Penn using approved data sharing protocols.,2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,INDUSTRY,,,,,,,2020,0.0
NCT04507373,,2019-01-31,2023-01-23,,2023-01-23,2020-08-07,2020-08-11,ACTUAL,2023-01-23,2023-02-14,ACTUAL,,,,2023-01-23,2023-02-14,ACTUAL,2018-08-17,ACTUAL,2018-08-17,2023-01,2023-01-31,2021-12-20,ACTUAL,2021-12-20,2021-12-20,ACTUAL,2021-12-20,,INTERVENTIONAL,,The 3 participants who were consented/ enrolled were not assigned/ randomized to the interventions because no grant was obtained for the study to continue further and the study was terminated.,7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin Associated Adverse Muscle Events,7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin,TERMINATED,,PHASE4,3.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,No grant obtained. Enrolled participants were not assigned to the intervention and was study terminated,f,,,,,t,f,,,t,,,,,,,,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,OTHER,,,,,,,2021,0.0
NCT03312751,,2017-10-05,2023-09-11,,2024-03-05,2017-10-12,2017-10-18,ACTUAL,2024-03-05,2024-03-12,ACTUAL,,,,2024-03-05,2024-03-12,ACTUAL,2019-02-06,ACTUAL,2019-02-06,2024-03,2024-03-31,2022-09-14,ACTUAL,2022-09-14,2021-08-18,ACTUAL,2021-08-18,,INTERVENTIONAL,,,Study to Assess the Efficacy and Safety of Emapalumab in Primary Haemophagocytic Lymphohistiocytosis,"An Open-label, Single Arm, Multicenter Study to Broaden Access to Emapalumab, an Anti-Interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and to Assess Its Efficacy, Safety, Impact on Quality of Life, and Long-term Outcome in Pediatric Patients With Primary Hemophagocytic Lymphohistiocytosis",COMPLETED,,PHASE3,35.0,ACTUAL,Swedish Orphan Biovitrum,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,INDUSTRY,,,,,,,2022,1.0
NCT04402957,,2020-05-12,,,2023-12-17,2020-05-25,2020-05-27,ACTUAL,,,,,,,2023-12-17,2023-12-22,ACTUAL,2020-10-14,ACTUAL,2020-10-14,2023-12,2023-12-31,2022-06-02,ACTUAL,2022-06-02,2021-05-27,ACTUAL,2021-05-27,,INTERVENTIONAL,,,LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19),"Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of LSALT Peptide as Prevention of Acute Respiratory Distress Syndrome (ARDS) and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)",COMPLETED,,PHASE2,61.0,ACTUAL,Arch Biopartners Inc.,,2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 17:45:18.397777,2024-10-15 17:45:18.397777,INDUSTRY,,,,,,,2022,1.0
NCT02927067,,2016-09-29,2022-12-19,,2023-02-02,2016-10-05,2016-10-06,ESTIMATED,2023-02-02,2023-03-03,ACTUAL,,,,2023-02-02,2023-03-03,ACTUAL,2017-04-14,ACTUAL,2017-04-14,2023-02,2023-02-28,2022-07-01,ACTUAL,2022-07-01,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,,Randomized set included all participants in the enrolled set for whom a randomization number had been assigned.,A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants,"A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients",COMPLETED,,PHASE3,553.0,ACTUAL,Takeda,,2.0,,,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,INDUSTRY,,,,,,,2022,1.0
NCT04718103,,2021-01-18,,,2024-07-05,2021-01-18,2021-01-22,ACTUAL,,,,,,,2024-07-05,2024-07-08,ACTUAL,2021-02-04,ACTUAL,2021-02-04,2024-06,2024-06-30,2024-04-11,ACTUAL,2024-04-11,2024-04-11,ACTUAL,2024-04-11,,INTERVENTIONAL,SWIFT-2,,A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype,"A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype",COMPLETED,,PHASE3,397.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,INDUSTRY,,,,,,,2024,1.0
NCT02620904,,2015-12-01,2020-12-11,,2021-01-30,2015-12-02,2015-12-03,ESTIMATED,2021-01-30,2021-02-18,ACTUAL,,,,2021-01-30,2021-02-18,ACTUAL,2016-07-14,ACTUAL,2016-07-14,2021-01,2021-01-31,2020-01,ACTUAL,2020-01-31,2019-10,ACTUAL,2019-10-31,,INTERVENTIONAL,MIFD,,Mifepristone Induction for Fetal Demise,"Mifepristone Induction for Fetal Demise, a Randomized Control Trial",TERMINATED,,PHASE4,9.0,ACTUAL,Montefiore Medical Center,Due to difficulty with recruitment the study was unable to be completed in the projected time frame. Despite efforts to enhance recruitment and extending the study duration very few persons were enrolled. Due to the limited enrollment no conclusions can be ascertained about the impact of mifepristone on the induction of labor in this setting.,2.0,,"unable to recruit. Projected completion was 2018 however, enrollment and recruitment were difficult. The study was terminated due to inability to enroll.",f,,,,t,,,,,,,,,,,NO,,2024-10-16 05:34:40.88875,2024-10-16 05:34:40.88875,OTHER,,,,,,,2020,0.0
NCT03745820,,2018-11-15,2023-03-23,,2023-03-23,2018-11-15,2018-11-19,ACTUAL,2023-03-23,2023-04-18,ACTUAL,,,,2023-03-23,2023-04-18,ACTUAL,2018-11-15,ACTUAL,2018-11-15,2023-03,2023-03-31,2022-04-07,ACTUAL,2022-04-07,2022-03-23,ACTUAL,2022-03-23,,INTERVENTIONAL,TALLY,Intent-to-treat (ITT) population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo).,A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS),"A Phase 2, Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BIIB104 in Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)",COMPLETED,,PHASE2,195.0,ACTUAL,Biogen,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,INDUSTRY,,,,,,,2022,1.0
NCT04485065,,2020-07-21,,,2023-02-14,2020-07-21,2020-07-24,ACTUAL,,,,,,,2023-02-14,2023-02-16,ACTUAL,2020-09-30,ACTUAL,2020-09-30,2023-02,2023-02-28,2024-08-20,ESTIMATED,2024-08-20,2023-12-30,ESTIMATED,2023-12-30,,INTERVENTIONAL,,,Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS,A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome,SUSPENDED,,PHASE1,120.0,ESTIMATED,Innovent Biologics (Suzhou) Co. Ltd.,,1.0,,Suspended for changes in development strategy,f,,,,f,f,f,,,,,,,,,,,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,INDUSTRY,,,,,,,2024,0.0
NCT04551053,,2020-09-11,2024-07-15,,2024-08-21,2020-09-11,2020-09-16,ACTUAL,2024-08-21,2024-08-23,ACTUAL,,,,2024-08-21,2024-08-23,ACTUAL,2021-05-26,ACTUAL,2021-05-26,2024-08,2024-08-31,2024-08-21,ACTUAL,2024-08-21,2023-08-16,ACTUAL,2023-08-16,,INTERVENTIONAL,,,To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304),"A Randomized, Double-Blind, Placebo-Controlled Study of the PI3Kδ Inhibitor Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib",TERMINATED,,PHASE3,177.0,ACTUAL,Incyte Corporation,,2.0,,The study was terminated due to futility.,f,,,,t,t,f,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency,2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,INDUSTRY,,,,,,,2024,0.0
NCT04467151,,2020-07-09,,,2020-10-20,2020-07-09,2020-07-10,ACTUAL,,,,,,,2020-10-20,2020-10-22,ACTUAL,2020-10,ESTIMATED,2020-10-31,2020-10,2020-10-31,2021-12,ESTIMATED,2021-12-31,2021-10,ESTIMATED,2021-10-31,,INTERVENTIONAL,,,"Administration of Anti-SARS-CoV-2 Convalescent Plasma in Hospitalized, Non-ICU Patients With COVID-19","A Randomized, Double-blind, Placebo-controlled Trial of Anti-SARS-CoV-2 Plasma in Hospitalized Non-ICU Patients With COVID-19",WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Southern California,,2.0,,Did not obtain funding to proceed with study,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,OTHER,,,,,,,2021,0.0
NCT03218683,,2017-07-06,,,2022-09-22,2017-07-13,2017-07-14,ACTUAL,,,,,,,2022-09-22,2022-09-23,ACTUAL,2017-08-02,ACTUAL,2017-08-02,2022-09,2022-09-30,2021-10-08,ACTUAL,2021-10-08,2021-10-08,ACTUAL,2021-10-08,,INTERVENTIONAL,,,Study of AZD5991 Alone or in Combination With Venetoclax in Relapsed or Refractory Haematologic Malignancies.,"A Phase 1/1b/2a, 3-Part, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Doses of AZD5991 Monotherapy and in Combination With Venetoclax in Subjects With Relapsed or Refractory Haematologic Malignancies",TERMINATED,,PHASE1,70.0,ACTUAL,AstraZeneca,,3.0,,Sponsor Decision,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,INDUSTRY,,,,,,,2021,0.0
NCT05464836,,2022-07-07,,,2024-08-15,2022-07-14,2022-07-19,ACTUAL,,,,,,,2024-08-15,2024-08-19,ACTUAL,2023-04-06,ACTUAL,2023-04-06,2024-08,2024-08-31,2024-08-12,ACTUAL,2024-08-12,2024-08-12,ACTUAL,2024-08-12,,INTERVENTIONAL,,,Phase II Study to Evaluate Safety and Efficacy of CB-103 With Venetoclax in Adolescent and Young Adult Patients With Relapsed/Refractory T-ALL or T-LBL,A Phase II Study to Evaluate Safety and Efficacy of CB-103 in Combination With Venetoclax in Adolescent and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL),TERMINATED,,PHASE2,2.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,The sponsor requested termination due to internal reprioritization of resources.,,,,,t,t,f,,,,,,,,,,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,OTHER,,,,,,,2024,0.0
NCT05533411,,2022-09-06,2024-07-08,,2024-07-08,2022-09-06,2022-09-09,ACTUAL,2024-07-08,2024-10-04,ACTUAL,,,,2024-07-08,2024-10-04,ACTUAL,2022-09-14,ACTUAL,2022-09-14,2024-07,2024-07-31,2023-01-05,ACTUAL,2023-01-05,2023-01-05,ACTUAL,2023-01-05,,INTERVENTIONAL,,All randomized participants.,A Study of Donanemab (LY3002813) in Healthy Chinese Participants,"A Parallel-group Treatment, Phase 1, Participant- and Investigator-Blind, Randomized Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Dose of Donanemab Compared With Placebo in Healthy Chinese Participants",COMPLETED,,PHASE1,36.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,INDUSTRY,,,,,,,2023,1.0
NCT03516903,,2018-04-10,,,2021-01-07,2018-04-23,2018-05-07,ACTUAL,,,,,,,2021-01-07,2021-01-11,ACTUAL,2018-04-17,ACTUAL,2018-04-17,2021-01,2021-01-31,2020-12-17,ACTUAL,2020-12-17,2020-12-17,ACTUAL,2020-12-17,,INTERVENTIONAL,,,Effect of Methotrexate Carried by a Lipid Nanoemulsion on Left Ventricular Remodeling After STEMI,Effect of Methotrexate Carried by a Lipid Nanoemulsion on Left Ventricular Remodeling After ST-elevation Myocardial Infarction,TERMINATED,,PHASE2/PHASE3,35.0,ACTUAL,University of Sao Paulo,,2.0,,"Due to the COVID-19 pandemic. With a second wave just beginning, and considering that we are testing an immunosuppressant in patients with high risk for COVID-19 complications, we would not be able to re-start recruitment safely in the near future.",f,,,,t,f,f,,,f,,,,,,YES,IPD can be shared after reasonable request approved by the study coordination.,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,OTHER,,,,,,,2020,0.0
NCT04351061,,2020-04-15,,,2021-11-29,2020-04-15,2020-04-17,ACTUAL,,,,,,,2021-11-29,2021-12-14,ACTUAL,2020-05-07,ACTUAL,2020-05-07,2021-11,2021-11-30,2021-11-24,ACTUAL,2021-11-24,2021-11-24,ACTUAL,2021-11-24,,INTERVENTIONAL,,,Acetazolamide for the Prevention of Post Operative CSF Leak,Pilot Study of Acetazolamide to Prevent Post Operative Cerebrospinal Fluid (CSF) Leak in Patients Undergoing Endoscopic Skull Base Surgery,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Miami,,1.0,,No participants were identified per inclusion/exclusion criteria,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,OTHER,,,,,,,2021,0.0
NCT03729362,,2018-10-10,2023-05-04,2021-10-07,2023-08-25,2018-11-01,2018-11-02,ACTUAL,2023-08-25,2023-09-11,ACTUAL,,2023-09-11,ACTUAL,2023-08-25,2023-09-11,ACTUAL,2018-12-04,ACTUAL,2018-12-04,2023-06,2023-06-30,2021-01-15,ACTUAL,2021-01-15,2020-12-15,ACTUAL,2020-12-15,,INTERVENTIONAL,PROPEL,All randomized participants who received at least 1 dose of the study drug.,A Study Comparing ATB200/AT2221 With Alglucosidase Alfa/Placebo in Adult Subjects With Late-onset Pompe Disease,A Phase 3 Double-blind Randomized Study to Assess the Efficacy and Safety of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late-onset Pompe Disease Compared With Alglucosidase Alfa/Placebo,COMPLETED,,PHASE3,125.0,ACTUAL,Amicus Therapeutics,,2.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:13:04.868399,2024-10-15 07:13:04.868399,INDUSTRY,,,,,,,2021,1.0
NCT04738318,,2021-01-27,2023-12-12,,2023-12-12,2021-02-03,2021-02-04,ACTUAL,2023-12-12,2023-12-29,ACTUAL,,,,2023-12-12,2023-12-29,ACTUAL,2022-06-16,ACTUAL,2022-06-16,2023-12,2023-12-31,2023-03-10,ACTUAL,2023-03-10,2023-03-10,ACTUAL,2023-03-10,,INTERVENTIONAL,SAFE,There were no participants randomized to the control arm.,Steroid Administration for Articular Fractures of the Elbow (SAFE Trial),"Steroid Administration for Articular Fractures of the Elbow (SAFE Trial): A Randomized, Controlled Trial of Perioperative Glucocorticoids During Treatment of Intraarticular Elbow Fractures",TERMINATED,,PHASE4,3.0,ACTUAL,Vanderbilt University Medical Center,"The study was terminated early and converted to a non-interventional, observational study model. Of the 3 participants consented prior to termination, only 2 were randomized to a treatment arm and only 1 completed study procedures.",2.0,,Switched to observational study type.,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,OTHER,,,,,,,2023,0.0
NCT04856475,,2021-03-30,,,2022-02-28,2021-04-19,2021-04-23,ACTUAL,,,,,,,2022-02-28,2022-03-02,ACTUAL,2021-11-24,ACTUAL,2021-11-24,2021-06,2021-06-30,2021-11-24,ACTUAL,2021-11-24,2021-11-24,ACTUAL,2021-11-24,,INTERVENTIONAL,NeraBrain,,Evaluation of Neratinib for Treatment and Prevention of Subsequent CNS Event(s) in Patients With Brain Metastasis of Advanced HER2 Positive Breast Cancer,An Open Label Phase II Study to Evaluate Neratinib for Treatment and Prevention of Subsequent CNS Event(s) in Patients With Brain Metastasis of Advanced HER2 Positive Breast Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,Jules Bordet Institute,,3.0,,Termination of collaboration with PUMA,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,OTHER,,,,,,,2021,0.0
NCT05469802,,2022-07-20,,,2024-03-11,2022-07-20,2022-07-22,ACTUAL,,,,,,,2024-03-11,2024-03-13,ACTUAL,2024-01-02,ESTIMATED,2024-01-02,2024-03,2024-03-31,2024-07-05,ESTIMATED,2024-07-05,2024-07-05,ESTIMATED,2024-07-05,,INTERVENTIONAL,,,A Study of Purified Inactivated Zika Virus Vaccine (PIZV) in Healthy Adults,"A Randomized, Observer-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Immunogenicity of the Purified Inactivated Zika Virus Vaccine (PIZV) Administered on Days 1 and 29 in Healthy Participants Aged 18 to 49 Years in the US",WITHDRAWN,,PHASE2,0.0,ACTUAL,Takeda,,2.0,,"Business reason, change in Zika virus epidemiology",f,,,,t,t,f,,,f,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 17:51:08.617379,2024-10-15 17:51:08.617379,INDUSTRY,,,,,,,2024,0.0
NCT05363215,,2022-05-03,,,2023-04-20,2022-05-03,2022-05-05,ACTUAL,,,,,,,2023-04-20,2023-04-24,ACTUAL,2022-08-10,ACTUAL,2022-08-10,2023-04,2023-04-30,2023-04-12,ACTUAL,2023-04-12,2023-04-12,ACTUAL,2023-04-12,,INTERVENTIONAL,,,A Study to Assess S-217622 in Participants With Renal Impairment and Healthy Participants,"A Phase 1, Open-label, Parallel-group Study to Assess the Pharmacokinetics, Safety, and Tolerability of S-217622 in Participants With Mild, Moderate, and Severe Renal Impairment and Healthy Control Participants",COMPLETED,,PHASE1,32.0,ACTUAL,Shionogi Inc.,,4.0,,,,,,,,t,f,,,,,,,,,,,2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,INDUSTRY,,,,,,,2023,1.0
NCT03587363,,2018-07-04,,,2021-03-26,2018-07-04,2018-07-16,ACTUAL,,,,,,,2021-03-26,2021-04-01,ACTUAL,2018-12-06,ACTUAL,2018-12-06,2021-03,2021-03-31,2020-12-22,ACTUAL,2020-12-22,2020-12-22,ACTUAL,2020-12-22,,INTERVENTIONAL,,,A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib,"A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib",TERMINATED,,PHASE1,26.0,ACTUAL,"Janssen Research & Development, LLC",,4.0,,Mild/moderate hepatic impairment (HI) cohorts completed with no impact to erdafitinib exposure. Severe HI cohort enrollment stopped early.,f,,,,f,f,f,,,,,,,,,,,2024-10-15 17:51:08.617379,2024-10-15 17:51:08.617379,INDUSTRY,,,,,,,2020,0.0
NCT03905447,,2019-03-06,,,2021-07-15,2019-04-04,2019-04-05,ACTUAL,,,,,,,2021-07-15,2021-07-16,ACTUAL,2019-09-17,ACTUAL,2019-09-17,2020-06,2020-06-30,2020-06-01,ACTUAL,2020-06-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,,,The Effect of Early Treatment of PC945 on Aspergillus Fumigatus Lung Infection in Lung Transplant Patients.,"An Open-label, Pilot Study to Assess Safety, Tolerability, Pharmacokinetics and Effects of Inhaled PC945 in the Pre-emptive Treatment of Aspergillus Fumigatus Colonisation in Lung Transplant Recipients",TERMINATED,,PHASE2,2.0,ACTUAL,Pulmocide Ltd,,2.0,,The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.,f,,,,f,f,f,,,,,,,,,,,2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,INDUSTRY,,,,,,,2020,0.0
NCT03860935,,2019-02-27,2024-05-10,,2024-06-05,2019-02-28,2019-03-04,ACTUAL,2024-06-05,2024-06-27,ACTUAL,,,,2024-06-05,2024-06-27,ACTUAL,2019-03-19,ACTUAL,2019-03-19,2024-06,2024-06-30,2023-05-11,ACTUAL,2023-05-11,2023-05-11,ACTUAL,2023-05-11,,INTERVENTIONAL,ATTRibute-CM,Safety Population,Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects With Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTRibute-CM Trial)",COMPLETED,,PHASE3,632.0,ACTUAL,"Eidos Therapeutics, a BridgeBio company",,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,INDUSTRY,,,,,,,2023,1.0
NCT02029690,,2013-12-16,,,2020-09-24,2014-01-06,2014-01-08,ESTIMATED,,,,,,,2020-09-24,2020-09-25,ACTUAL,2014-04-23,ACTUAL,2014-04-23,2019-03,2019-03-31,2020-06,ACTUAL,2020-06-30,2018-08-15,ACTUAL,2018-08-15,,INTERVENTIONAL,TRAP,,Ph 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin,Phase 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ADIPemCis) (TRAP Study),TERMINATED,,PHASE1,85.0,ACTUAL,Polaris Group,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,INDUSTRY,,,,,,,2020,0.0
NCT04938635,,2021-06-16,,,2022-11-07,2021-06-16,2021-06-24,ACTUAL,,,,,,,2022-11-07,2022-11-10,ACTUAL,2021-09-20,ACTUAL,2021-09-20,2022-03,2022-03-31,2023-07,ESTIMATED,2023-07-31,2023-07,ESTIMATED,2023-07-31,,INTERVENTIONAL,,,Efficacy and Safety Study of Multiple Doses of VIT-2763 in Adults With Transfusion-dependent Beta-thalassemia,"A Phase 2b, Double-blind, Randomised, Placebo-controlled, Multicentre Study to Assess the Efficacy and Safety of VIT-2763 Multiple Doses in Adults With Transfusion-dependent Beta-thalassaemia",WITHDRAWN,,PHASE2,0.0,ACTUAL,Vifor Pharma,,4.0,,Strategic reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,INDUSTRY,,,,,,,2023,0.0
NCT02777372,,2016-04-19,2022-09-06,,2022-10-25,2016-05-16,2016-05-19,ESTIMATED,2022-10-25,2022-11-17,ACTUAL,,,,2022-10-25,2022-11-17,ACTUAL,2016-04-01,ACTUAL,2016-04-01,2022-10,2022-10-31,2021-12-01,ACTUAL,2021-12-01,2021-12-01,ACTUAL,2021-12-01,,INTERVENTIONAL,,,Stress & Premenstrual Symptoms Study,"Psychophysiology, Neurosteroids, and Stress in Premenstrual Dysphoric Disorder",COMPLETED,,PHASE4,84.0,ACTUAL,Johns Hopkins University,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,OTHER,,,,,,,2021,1.0
NCT04737330,,2020-11-20,,,2023-10-05,2021-02-02,2021-02-03,ACTUAL,,,,,,,2023-10-05,2023-10-06,ACTUAL,2021-11-29,ACTUAL,2021-11-29,2023-10,2023-10-31,2023-05-16,ACTUAL,2023-05-16,2023-05-16,ACTUAL,2023-05-16,,INTERVENTIONAL,ORBIT,,A Study of the Efficacy and Safety of Secukinumab 300 mg in Patients With Thyroid Eye Disease (TED),"A Two-year Multi-center Phase 3 Study to Investigate the Efficacy and Safety of Secukinumab in Adult Patients With Active, Moderate to Severe Thyroid Eye Disease (ORBIT), With a Randomized, Parallel-group, Double-blind, Placebo-controlled, 16-week Treatment Period, and a Follow-up/Retreatment Period",TERMINATED,,PHASE3,28.0,ACTUAL,Novartis,,2.0,,Analysis of blinded patient data showed a very low probability of the study meeting the primary efficacy endpoints. No safety concerns were identified,f,,,,f,f,f,,,,,,,,,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,INDUSTRY,,,,,,,2023,0.0
NCT04285580,,2020-02-24,2023-05-12,,2023-05-12,2020-02-24,2020-02-26,ACTUAL,2023-05-12,2023-06-08,ACTUAL,,,,2023-05-12,2023-06-08,ACTUAL,2020-06-11,ACTUAL,2020-06-11,2023-05,2023-05-31,2022-05-14,ACTUAL,2022-05-14,2022-05-14,ACTUAL,2022-05-14,,INTERVENTIONAL,,"All participants who have received study intervention (ie, Bimatoprost SR administration or LUMIGAN 0.01%) with at least 1 postbaseline IOP assessment.",A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension,An Evaluation of the 24-Hour Intraocular Pressure(IOP)-Lowering Effect of Bimatoprost Sustained-Release(SR) in Participants With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT),COMPLETED,,PHASE3,37.0,ACTUAL,AbbVie,,2.0,,,t,,,,f,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,INDUSTRY,,NCT05338606,AVAILABLE,,,,2022,1.0
NCT01113476,,2010-04-28,,,2022-08-31,2010-04-28,2010-04-30,ESTIMATED,,,,,,,2022-08-31,2022-09-02,ACTUAL,2010-04-27,ACTUAL,2010-04-27,2022-08,2022-08-31,2022-08-12,ACTUAL,2022-08-12,2022-08-12,ACTUAL,2022-08-12,,INTERVENTIONAL,,,"Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies","Phase I Study of Combination of Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies",COMPLETED,,PHASE1,176.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,OTHER,,,,,,,2022,1.0
NCT05034874,,2021-08-30,2024-08-30,,2024-09-24,2021-08-30,2021-09-05,ACTUAL,2024-09-24,2024-10-04,ACTUAL,,,,2024-09-24,2024-10-04,ACTUAL,2022-06-09,ACTUAL,2022-06-09,2024-05,2024-05-31,2023-11-07,ACTUAL,2023-11-07,2023-09-11,ACTUAL,2023-09-11,,INTERVENTIONAL,OUTLAST,,Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200,"A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200 in Treatment-Seeking Individuals With Methamphetamine Use Disorder",TERMINATED,,PHASE2,61.0,ACTUAL,"InterveXion Therapeutics, LLC",Early termination due to missing data leading to small numbers of participants analyzed. Participants did not submit drug tests as required.,2.0,,Interim analysis concluded planned study numbers combined with participant dropout rates were insufficient to meet primary endpoint.,f,,,,t,t,f,,,,,,These datasets will be available for distribution following submission to the FDA of the Clinical Study Report and publication. They will be available for 2 years after the initial publication.,These datasets and associated documentation will be made available on CD by the Sponsor to requestors under a data sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology and not distributing to third parties; and (3) a commitment to destroying or returning the data after analyses are completed. Requests should be sent to intervexion@gmail.com.,,YES,"Final datasets are expected to contain IXT-m200 concentrations and immunogenicity results, METH use frequencies, Treatment Effectiveness Assessment scores, and safety data over time. No individually identifiable private information will be distributed.",2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,INDUSTRY,,,,,,,2023,0.0
NCT04461600,,2020-06-29,2023-11-23,,2024-01-17,2020-07-02,2020-07-08,ACTUAL,2024-01-17,2024-02-12,ACTUAL,,,,2024-01-17,2024-02-12,ACTUAL,2020-08-14,ACTUAL,2020-08-14,2024-01,2024-01-31,2022-10-11,ACTUAL,2022-10-11,2022-03-23,ACTUAL,2022-03-23,,INTERVENTIONAL,TENACITY,,A Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer,"A Phase 2, Multi-center, Open-label, Single Arm Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer",TERMINATED,,PHASE2,18.0,ACTUAL,"Ayala Pharmaceuticals, Inc,",,1.0,,Sponsor's decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,INDUSTRY,,,,,,,2022,0.0
NCT06146374,,2023-11-22,,,2024-10-01,2023-11-22,2023-11-24,ACTUAL,,,,,,,2024-10-01,2024-10-03,ACTUAL,2024-04-09,ACTUAL,2024-04-09,2023-12-26,2023-12-26,2024-07-08,ACTUAL,2024-07-08,2024-07-08,ACTUAL,2024-07-08,,INTERVENTIONAL,,,Safety Study of SLV213 for the Treatment of COVID-19.,"A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose, Phase 1 Study of SLV213 in Healthy Volunteers",TERMINATED,,PHASE1,16.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,3.0,,DMID unanimously arrived at a recommendation to terminate the study after study met cohort halting criteria.,f,,,,,t,f,,,f,,,,,,,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,NIH,,,,,,,2024,0.0
NCT03887624,,2019-03-02,,,2022-05-15,2019-03-20,2019-03-25,ACTUAL,,,,,,,2022-05-15,2022-05-20,ACTUAL,2019-05-21,ACTUAL,2019-05-21,2022-05,2022-05-31,2021-04-01,ACTUAL,2021-04-01,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,,,Investigate the Clinical Responses of Ethosuximide in Patients With Treatment-Resistant Depression.,"A Randomized, Parallel-group，Placebo-controlled, Double-blind Clinical Trial to Evaluate the Efficacy and Safety of Ethosuximide in Chinese Patients With Treatment-Resistant Depression.",TERMINATED,,EARLY_PHASE1,16.0,ACTUAL,Zhejiang University,,2.0,,Participates could not stand the side effects,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 17:51:08.617379,2024-10-15 17:51:08.617379,OTHER,,,,,,,2021,0.0
NCT03608618,,2018-07-16,,,2021-08-30,2018-07-24,2018-08-01,ACTUAL,,,,,,,2021-08-30,2021-09-05,ACTUAL,2018-08-27,ACTUAL,2018-08-27,2021-08,2021-08-31,2021-08-24,ACTUAL,2021-08-24,2021-02-11,ACTUAL,2021-02-11,,INTERVENTIONAL,,,Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma,"A Phase 1 Study of Intraperitoneal MCY-M11 Therapy for Women With Platinum Resistant High Grade Serous Adenocarcinoma of the Ovary, Primary Peritoneum, or Fallopian Tube, or Subjects With Peritoneal Mesothelioma With Recurrence After Prior Chemotherapy",TERMINATED,,PHASE1,14.0,ACTUAL,"MaxCyte, Inc.",,4.0,,Sponsor shift in focus,,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-15 17:51:08.617379,2024-10-15 17:51:08.617379,INDUSTRY,,,,,,,2021,0.0
NCT01974479,,2013-10-20,,,2019-04-10,2013-10-27,2013-11-01,ESTIMATED,,,,,,,2019-04-10,2019-04-12,ACTUAL,2013-09,ACTUAL,2013-09-30,2019-04,2019-04-30,2020-02,ESTIMATED,2020-02-29,2017-02,ACTUAL,2017-02-28,,INTERVENTIONAL,,,Pilot Study of Redirected Haploidentical Natural Killer Cell Infusions for B-Lineage Acute Lymphoblastic Leukemia,Pilot Study of Redirected Haploidentical Natural Killer Cell Infusions for B-Lineage Acute Lymphoblastic Leukemia,SUSPENDED,,PHASE1,20.0,ESTIMATED,"National University Health System, Singapore",,1.0,,Suspended for an interim review of (CAR) CD19 research strategy for the treatment of CD19 positive ALL.,f,,,,f,,,,,,,,,,,,,2024-10-17 03:46:19.112028,2024-10-17 03:46:19.112028,OTHER,,,,,,,2020,0.0
NCT03053440,,2017-02-07,2023-03-29,,2023-05-17,2017-02-12,2017-02-15,ACTUAL,2023-05-17,2023-06-09,ACTUAL,,,,2023-05-17,2023-06-09,ACTUAL,2017-01-25,ACTUAL,2017-01-25,2023-05,2023-05-31,2022-06-21,ACTUAL,2022-06-21,2022-06-21,ACTUAL,2022-06-21,,INTERVENTIONAL,ASPEN,Intent to Treat (ITT) Analysis Set: Includes all randomized participants assigned to an arm.,A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM),"A Phase 3, Randomized, Open-Label, Multicenter Study Comparing the Efficacy and Safety of the Bruton's Tyrosine Kinase (BTK) Inhibitors BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM)",COMPLETED,,PHASE3,201.0,ACTUAL,BeiGene,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,,2024-10-15 17:51:08.617379,2024-10-15 17:51:08.617379,INDUSTRY,,,,,,,2022,1.0
NCT05315713,,2022-03-31,2024-07-16,,2024-09-24,2022-03-31,2022-04-07,ACTUAL,2024-09-24,2024-10-04,ACTUAL,,,,2024-09-24,2024-10-04,ACTUAL,2022-05-10,ACTUAL,2022-05-10,2024-09,2024-09-30,2023-07-19,ACTUAL,2023-07-19,2023-07-19,ACTUAL,2023-07-19,,INTERVENTIONAL,,,"An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Participants With B-Cell Non-Hodgkin Lymphoma","A Phase Ib/II Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma",TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,Hoffmann-La Roche,Early termination led to small numbers of participants for analysis.,2.0,,Study was terminated due to Sponsor decision.,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,INDUSTRY,,,,,,,2023,0.0
NCT03342300,,2017-11-08,,,2020-05-15,2017-11-09,2017-11-14,ACTUAL,,,,,,,2020-05-15,2020-05-19,ACTUAL,2017-11-06,ACTUAL,2017-11-06,2020-05,2020-05-31,2020-12-30,ESTIMATED,2020-12-30,2020-11-15,ESTIMATED,2020-11-15,,INTERVENTIONAL,PDVPSTS,,"Pegylated Liposomal Doxorubicin Versus Pirarubicin Plus Ifosfamide, Dacarbazine in Locally Advanced, Unresectable or Metastatic Soft-tissue Sarcoma","Comparing the Effectiveness and Toxicity for Locally Advanced, Unresectable or Metastatic Soft-tissue Sarcoma Patients Who Had Received Total Dose of Anthracycline Antibiotics More Than 300mg/m2 With Pegylated Liposomal Doxorubicin Versus Pirarubicin Plus Ifosfamide, Dacarbazine, a Multicentre, Open-label, Randomised Phase 2 Trial",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Peking University People's Hospital,,2.0,,No participants enrolled,f,,,,t,f,f,,,,,,,,,YES,,2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,OTHER,,,,,,,2020,0.0
NCT03036800,,2016-12-20,2023-02-27,,2024-03-04,2017-01-25,2017-01-30,ESTIMATED,2024-03-04,2024-08-13,ACTUAL,,,,2024-03-04,2024-08-13,ACTUAL,2017-11-28,ACTUAL,2017-11-28,2023-01,2023-01-31,2022-02-25,ACTUAL,2022-02-25,2021-02-28,ACTUAL,2021-02-28,,INTERVENTIONAL,STRIVE,,Saxenda in Obesity Services (STRIVE Study),EFFECTIVENESS AND COST OF INTEGRATING A PROTOCOL WITH USE OF LIRAGLUTIDE 3.0 MG INTO AN OBESITY SERVICE: (STRIVE Study),COMPLETED,,PHASE4,392.0,ACTUAL,University of Leicester,"Although the trial was not interrupted during COVID-19 we did issue an USM to the REC \& MHRA during the pandemic to explain that certain aspects of the trial would not be possible, however measures were put in place to ensure participant safety.",2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,OTHER,,,,,,,2022,1.0
NCT02431247,,2015-04-27,2018-08-15,2018-03-02,2022-09-27,2015-04-27,2015-04-30,ESTIMATED,2018-08-15,2018-09-14,ACTUAL,2018-03-02,2018-03-05,ACTUAL,2022-09-27,2022-09-28,ACTUAL,2015-07-06,ACTUAL,2015-07-06,2022-09,2022-09-30,2020-09-30,ACTUAL,2020-09-30,2017-03-02,ACTUAL,2017-03-02,,INTERVENTIONAL,,The intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.,A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects,"A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicistat Fixed Dose Combination Coadministered With Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 Infected Subjects",COMPLETED,,PHASE3,725.0,ACTUAL,Janssen Sciences Ireland UC,,2.0,,,f,,,,t,,f,,,,,,,,,,,2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,INDUSTRY,,,,,,,2020,1.0
NCT03222492,,2017-07-17,2024-03-11,,2024-04-22,2017-07-18,2017-07-19,ACTUAL,2024-04-22,2024-05-17,ACTUAL,,,,2024-04-22,2024-05-17,ACTUAL,2017-09-20,ACTUAL,2017-09-20,2024-04,2024-04-30,2023-04-10,ACTUAL,2023-04-10,2023-04-10,ACTUAL,2023-04-10,,INTERVENTIONAL,BRAVOS,"Randomized participants in each cohort were randomized 6:2 to Brentuximab Vedotin or placebo, respectively.",Brentuximab Vedotin for Systemic Sclerosis,"Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis BRAVOS: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study (ITN075AI)",COMPLETED,,PHASE1/PHASE2,17.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),Due to slow enrollment the study was stopped before fully enrolling cohort 2 (1.2 mg/kg) and before starting cohort 3 (1.8 mg/kg).,6.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,NIH,,,,,,,2023,1.0
NCT03059446,,2017-02-03,2022-01-04,,2022-01-04,2017-02-16,2017-02-23,ACTUAL,2022-01-04,2022-02-02,ACTUAL,,,,2022-01-04,2022-02-02,ACTUAL,2017-02-14,ACTUAL,2017-02-14,2021-09,2021-09-30,2021-01-05,ACTUAL,2021-01-05,2021-01-05,ACTUAL,2021-01-05,,INTERVENTIONAL,,Safety Population included all participants who received at least one dose of study drug.,Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis,Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NASH),TERMINATED,,PHASE2,167.0,ACTUAL,"Tobira Therapeutics, Inc.",,1.0,,This study was terminated early due to lack of efficacy based on the results of Part I of the AURORA study.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,INDUSTRY,,,,,,,2021,0.0
NCT04024384,,2019-07-01,,,2020-03-25,2019-07-16,2019-07-18,ACTUAL,,,,,,,2020-03-25,2020-03-27,ACTUAL,2019-07,ESTIMATED,2019-07-31,2019-07,2019-07-31,2024-07,ESTIMATED,2024-07-31,2024-07,ESTIMATED,2024-07-31,,INTERVENTIONAL,DARALLO,,Daratumumab as Maintenance After Peripheral Blood Stem Cell Transplantation From HLA-identical or Haploidentical Family Donor in the Treatment of Refractory or Relapsed Multiple Myeloma: a Phase 2 Trial,Daratumumab as Maintenance After Peripheral Blood Stem Cell Transplantation From HLA-identical or Haploidentical Family Donor in the Treatment of Refractory or Relapsed Multiple Myeloma: a Phase 2 Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,1.0,,Promotor decision,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,OTHER,,,,,,,2024,0.0
NCT05007678,,2021-07-16,,,2023-02-23,2021-08-12,2021-08-16,ACTUAL,,,,,,,2023-02-23,2023-02-27,ACTUAL,2020-09-16,ACTUAL,2020-09-16,2023-02,2023-02-28,2022-07-01,ACTUAL,2022-07-01,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,DEFEAT-COVID,,Targeting de Novo Pyrimidine Biosynthesis by Leflunomide for the Treatment of COVID-19 Virus Disease,Targeting de Novo Pyrimidine Biosynthesis by Leflunomide as a Novel Concept for the Treatment of Corona Virus Disease 2019 (COVID-19),COMPLETED,,PHASE3,178.0,ACTUAL,Ashford and St. Peter's Hospitals NHS Trust,,2.0,,,f,,,,t,f,f,,,,,,Within 2 years from publication of the main results,The anonymized data may be made available upon request following approval from the Trial Management Group and the Sponsor.,,YES,We plan to share the data supporting the results in a publication.,2024-10-15 17:51:08.617379,2024-10-15 17:51:08.617379,OTHER,,,,,,,2022,0.0
NCT01331018,,2011-03-16,,,2024-05-15,2011-04-06,2011-04-07,ESTIMATED,,,,,,,2024-05-15,2024-05-17,ACTUAL,2012-02-22,ACTUAL,2012-02-22,2024-05,2024-05-31,2024-02-15,ACTUAL,2024-02-15,2024-02-15,ACTUAL,2024-02-15,,INTERVENTIONAL,,,Gene Therapy for Fanconi Anemia,Gene Transfer for Patients With Fanconi Anemia Complementation Group A (FANCA),TERMINATED,,PHASE1,3.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,Study ended early due to end of funding.,f,,,,t,,,,,,,,,,,,,2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,OTHER,,,,,,,2024,0.0
NCT04552262,,2020-09-11,,,2022-08-22,2020-09-11,2020-09-17,ACTUAL,,,,,,,2022-08-22,2022-08-23,ACTUAL,2020-09-30,ACTUAL,2020-09-30,2022-08,2022-08-31,2021-05-05,ACTUAL,2021-05-05,2020-12-21,ACTUAL,2020-12-21,,INTERVENTIONAL,,,Study to Learn More About the Effect of a New Drug Called BAY2327949 on the Blood Flow Through Kidneys in Adult Participants With Moderate Chronic Kidney Disease,"A Randomized, 2-way Crossover, Placebo-controlled, Double-blind Study to Evaluate Effects of Single Oral Doses of BAY 2327949 on Renal Perfusion in Participants With Moderate Chronic Kidney Disease",TERMINATED,,PHASE1,7.0,ACTUAL,Bayer,,2.0,,Terminated,f,,,,f,f,f,,,,,,,,,UNDECIDED,"Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,INDUSTRY,,,,,,,2021,0.0
NCT03044795,,2017-02-02,,,2024-05-02,2017-02-02,2017-02-07,ESTIMATED,,,,,,,2024-05-02,2024-05-03,ACTUAL,2019-11,ESTIMATED,2019-11-30,2024-05,2024-05-31,2020-11,ESTIMATED,2020-11-30,2020-11,ESTIMATED,2020-11-30,,INTERVENTIONAL,REPAIR,,Response to PARP Inhibitor Predicted by the RAD51 Assay,Phase II Study With PARP Inhibitor Veliparib (ABT-888) in Patients With Increased Risk of Homologous Recombination Deficiency to Determine the Value of an (Ex-vivo) RAD51 Assay as a Biomarker,WITHDRAWN,,PHASE2,0.0,ACTUAL,University Medical Center Groningen,,2.0,,The study never started,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,OTHER,,,,,,,2020,0.0
NCT03329378,,2017-10-30,2023-07-07,,2023-08-18,2017-10-30,2017-11-06,ACTUAL,2023-08-18,2023-08-22,ACTUAL,,,,2023-08-18,2023-08-22,ACTUAL,2019-01-24,ACTUAL,2019-01-24,2023-08,2023-08-31,2021-03-07,ACTUAL,2021-03-07,2021-03-07,ACTUAL,2021-03-07,,INTERVENTIONAL,,,Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer,A Phase II Randomized Trial Evaluating Neoadjuvant Dose-Dense Doxorubicin/Cyclophosphamide Followed by Paclitaxel/Trastuzumab/Pertuzumab (AC THP) and Docetaxel/Carboplatin/Trastuzumab/Pertuzumab (TCHP) For Early Her2Neu Positive Breast Cancer,TERMINATED,,PHASE2,7.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,2.0,,"Data Safety Monitoring Board is in agreement with the study findings so far and the stopping rule has been met, which suspends the study treatment arms in March 2021.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2021,0.0
NCT04449029,,2020-06-23,2023-03-01,,2023-04-21,2020-06-23,2020-06-26,ACTUAL,2023-04-21,2023-05-16,ACTUAL,,,,2023-04-21,2023-05-16,ACTUAL,2020-07-27,ACTUAL,2020-07-27,2023-04,2023-04-30,2022-03-18,ACTUAL,2022-03-18,2022-03-18,ACTUAL,2022-03-18,,INTERVENTIONAL,B-Clear,,A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB),"Phase IIb Multi-Center, Randomised, Partial-Blind Parallel Cohort Study to Assess the Efficacy and Safety of Treatment With GSK3228836 in Participants With Chronic Hepatitis B Virus (B-Clear)",COMPLETED,,PHASE2,457.0,ACTUAL,GlaxoSmithKline,,8.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,INDUSTRY,,,,,,,2022,0.0
NCT04952519,,2021-06-28,,,2022-09-28,2021-07-02,2021-07-07,ACTUAL,,,,,,,2022-09-28,2022-09-30,ACTUAL,2021-03-30,ACTUAL,2021-03-30,2021-07,2021-07-31,2022-03-10,ACTUAL,2022-03-10,2022-03-10,ACTUAL,2022-03-10,,INTERVENTIONAL,TITAN,,Efficacy of Amantadine Treatment in COVID-19 Patients,Efficacy of Amantadine Treatment in COVID-19 Patients,TERMINATED,,PHASE3,193.0,ACTUAL,Noblewell,,2.0,,"The annual analysis did not show the efficacy of the investigational medicinal product in this application, therefore the study was not continued.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,INDUSTRY,,,,,,,2022,0.0
NCT04343768,,2020-04-08,,,2020-05-02,2020-04-09,2020-04-13,ACTUAL,,,,,,,2020-05-02,2020-05-05,ACTUAL,2020-04-09,ACTUAL,2020-04-09,2020-05,2020-05-31,2020-04-27,ACTUAL,2020-04-27,2020-04-27,ACTUAL,2020-04-27,,INTERVENTIONAL,COVIFERON,,"An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial","An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial",COMPLETED,,PHASE2,60.0,ACTUAL,Shahid Beheshti University of Medical Sciences,,3.0,,,f,,,,t,f,f,,,f,,,One year after the publication of the results in a journal.,Qualifying researchers who reach out to Dr. Seyed Sina Naghibi Irvani at sina.irvani@sbmu.ac.ir or sina.irvani@gmail.com and submit a proposal with a valuable research question.,,YES,"One year after the publication of the results in a journal, Qualifying researchers who reach out to Dr. Seyed Sina Naghibi Irvani at sina.irvani@sbmu.ac.ir or sina.irvani@gmail.com and submit a proposal with a valuable research question can have access to data and supporting information.",2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,OTHER,,,,,,,2020,1.0
NCT02927405,,2016-10-05,,,2021-05-20,2016-10-06,2016-10-07,ESTIMATED,,,,,,,2021-05-20,2021-05-25,ACTUAL,2020-03-04,ESTIMATED,2020-03-04,2021-05,2021-05-31,2020-03-31,ESTIMATED,2020-03-31,2020-03-31,ESTIMATED,2020-03-31,,INTERVENTIONAL,,,Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain,Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain,WITHDRAWN,,PHASE4,0.0,ACTUAL,State University of New York - Downstate Medical Center,,2.0,,"Did not get the study to take off, did not recruit any subjects, and then closed the study.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:18:45.824226,2024-10-15 07:18:45.824226,OTHER,,,,,,,2020,0.0
NCT04637009,,2020-11-15,,,2024-08-01,2020-11-15,2020-11-19,ACTUAL,,,,,,,2024-08-01,2024-08-02,ACTUAL,2020-12-21,ACTUAL,2020-12-21,2024-08,2024-08-31,2023-02-20,ACTUAL,2023-02-20,2023-02-20,ACTUAL,2023-02-20,,INTERVENTIONAL,,,A Study of TAS1553 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) and Other Myeloid Neoplasms,"A Phase 1 Study of Safety, Pharmacokinetics and Preliminary Activity of TAS1553 in Subjects With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) and Other Myeloid Neoplasms",TERMINATED,,PHASE1,20.0,ACTUAL,"Astex Pharmaceuticals, Inc.",,2.0,,termination due to portfolio prioritization,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2023,0.0
NCT01307605,,2011-03-01,,,2023-06-26,2011-03-02,2011-03-03,ESTIMATED,,,,,,,2023-06-26,2023-06-27,ACTUAL,2011-02-09,ACTUAL,2011-02-09,2023-06,2023-06-30,2023-01-25,ACTUAL,2023-01-25,2014-06-20,ACTUAL,2014-06-20,,INTERVENTIONAL,,,Rituximab With or Without Lenalidomide in Treating Patients With Previously Untreated Follicular Lymphoma,"Rituximab Plus Lenalidomide or Rituximab Monotherapy for Untreated Patients With Follicular Lymphoma in Need of Therapy. A Randomized, Open-Label, Multicenter Phase II Trial.",TERMINATED,,PHASE2,154.0,ACTUAL,Swiss Group for Clinical Cancer Research,,2.0,,It was decided by the trial team to stop the collection of follow up data in trial SAKK 35/10.,f,,,,t,,,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,OTHER,,,,,,,2023,0.0
NCT04132375,,2019-07-19,,,2023-07-18,2019-10-16,2019-10-18,ACTUAL,,,,,,,2023-07-18,2023-07-19,ACTUAL,2019-07-17,ACTUAL,2019-07-17,2022-03,2022-03-31,2022-07-19,ACTUAL,2022-07-19,2022-05-04,ACTUAL,2022-05-04,,INTERVENTIONAL,,,"Phase 2/3 Study to Evaluate PK, Safety & Efficacy of INM004 in STEC Positive Pediatric Patients for Prevention of HUS","A Double-blind, Placebo-controlled, Adaptive, Phase 2/3 Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of INM004 in Pediatric Patients With Shiga Toxin-positive Bloody Diarrhea for Prevention of Hemolytic Uremic Syndrome",TERMINATED,,PHASE2/PHASE3,11.0,ACTUAL,Inmunova S.A.,,5.0,,Due to COVID pandemia enrolment was stopped on 20March2020,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,OTHER,,,,,,,2022,0.0
NCT01548144,,2012-03-05,,,2021-09-03,2012-03-07,2012-03-08,ESTIMATED,,,,,,,2021-09-03,2021-09-13,ACTUAL,2012-04,ACTUAL,2012-04-30,2021-09,2021-09-30,2021-08-26,ACTUAL,2021-08-26,2021-08-26,ACTUAL,2021-08-26,,INTERVENTIONAL,,,Pazopanib or Pemetrexed and Crizotinib in Advanced Cancer,"A Two Steps Phase I Trial of Pazopanib or Pemetrexed in Combination With Crizotinib Followed by the Triplet, Crizotinib Plus Pazopanib Plus Pemetrexed in Patients With Advanced Malignancies",TERMINATED,,PHASE1,178.0,ACTUAL,M.D. Anderson Cancer Center,,4.0,,PI request,f,,,,f,t,f,,,,,,,,,,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,OTHER,,,,,,,2021,0.0
NCT03705273,,2018-10-09,2021-09-13,,2021-10-11,2018-10-10,2018-10-15,ACTUAL,2021-10-11,2021-11-08,ACTUAL,,,,2021-10-11,2021-11-08,ACTUAL,2018-10-23,ACTUAL,2018-10-23,2021-10,2021-10-31,2020-10-02,ACTUAL,2020-10-02,2020-10-02,ACTUAL,2020-10-02,,INTERVENTIONAL,,,Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup,Comparison of Dexamethasone Oral Preparations to Assess Palatability and Adverse Effects in Children With Asthma and Croup,TERMINATED,,PHASE4,40.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,Dr. Arnold assisted in designing and initiating study for a pharmacology PhD candidate. The candidate left the institution and study enrollment was terminated.,f,,,,f,t,f,,,f,,,,,,UNDECIDED,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,OTHER,,,,,,,2020,0.0
NCT05037188,,2021-09-07,,,2023-01-27,2021-09-07,2021-09-08,ACTUAL,,,,,,,2023-01-27,2023-01-30,ACTUAL,2021-08-10,ACTUAL,2021-08-10,2023-01,2023-01-31,2022-04-18,ACTUAL,2022-04-18,2022-04-18,ACTUAL,2022-04-18,,INTERVENTIONAL,COVER,,Clinical Study of the Safety and Immunogenicity of a Recombinant Viral Vector AAV5 (Adeno-Associated Virus Type 5 )-RBD (Receptor Binding Domain)-S Vaccine for the Prevention of Coronavirus Infection (COVID-19),"A Randomized, Double-blind, Placebo-controlled, Adaptive, Seamless Phase I / II Clinical Study of the Safety and Immunogenicity of a Recombinant Viral Vector AAV5-RBD-S Vaccine for the Prevention of Coronavirus Infection (COVID-19)",TERMINATED,,PHASE1/PHASE2,50.0,ACTUAL,Biocad,,6.0,,Sponsor's decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2022,0.0
NCT03843710,,2019-02-14,,,2023-03-30,2019-02-14,2019-02-18,ACTUAL,,,,,,,2023-03-30,2023-04-03,ACTUAL,2020-03,ESTIMATED,2020-03-31,2023-03,2023-03-31,2022-03,ESTIMATED,2022-03-31,2022-02,ESTIMATED,2022-02-28,,INTERVENTIONAL,REPAIR-ALS,,31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis (REPAIR-ALS),"A Phase 2, Pilot Open Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis",WITHDRAWN,,PHASE2,0.0,ACTUAL,Clene Nanomedicine,,4.0,,Study execution discontinued at this time.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2022,0.0
NCT03794960,,2019-01-03,,,2020-12-04,2019-01-03,2019-01-07,ACTUAL,,,,,,,2020-12-04,2020-12-08,ACTUAL,2019-12-14,ESTIMATED,2019-12-14,2020-12,2020-12-31,2023-12-14,ESTIMATED,2023-12-14,2021-12-14,ESTIMATED,2021-12-14,,INTERVENTIONAL,DAY,,Diabetes AutoimmunitY Withdrawn in Established Patients (DAY),"A Phase 2b Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of TOL-3021 in Patients With Established Type 1 Diabetes Mellitus",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Tolerion, Inc.",,2.0,,Modification to Clinical Development Plan,,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2023,0.0
NCT05286762,,2022-03-01,,,2024-08-13,2022-03-09,2022-03-18,ACTUAL,,,,,,,2024-08-13,2024-08-15,ACTUAL,2023-07-25,ACTUAL,2023-07-25,2024-01,2024-01-31,2024-01-24,ACTUAL,2024-01-24,2024-01-24,ACTUAL,2024-01-24,,INTERVENTIONAL,,,Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301,"A Phase 3, Double-blind, Randomized, Placebo-controlled, Multi-center, Fixed-dose, Parallel Group Efficacy and Safety in Pediatrics (6-17) With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)",TERMINATED,,PHASE3,103.0,ACTUAL,Cingulate Therapeutics,,4.0,,Continuation of the study is not required for NDA submission via the 505(b)(2) pathway,f,,,,f,t,f,,,,,,,,,NO,Overall study data as required by FDAAA801 will be shared upon completion of the study.,2024-10-15 17:51:08.617379,2024-10-15 17:51:08.617379,INDUSTRY,,,,,,,2024,0.0
NCT04005989,,2019-06-13,,,2022-09-20,2019-07-01,2019-07-02,ACTUAL,,,,,,,2022-09-20,2022-09-22,ACTUAL,2021-12-01,ESTIMATED,2021-12-01,2021-07,2021-07-31,2022-12-20,ESTIMATED,2022-12-20,2022-11-30,ESTIMATED,2022-11-30,,INTERVENTIONAL,ADMIRE,,Adipose Stromal Cells Injection in the Myocardium for Induction of Revascularization,Adipose Stromal Cells Injection in the Myocardium for Induction of Revascularization,WITHDRAWN,,PHASE3,0.0,ACTUAL,Hospital do Coracao,,4.0,,Due to logistic issues during COVID-19 pandemic,f,,,,,f,f,,,,,,,,,,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,OTHER,,,,,,,2022,0.0
NCT05394350,,2022-05-23,2024-08-19,,2024-09-25,2022-05-23,2022-05-27,ACTUAL,2024-09-25,2024-10-04,ACTUAL,,,,2024-09-25,2024-10-04,ACTUAL,2022-07-07,ACTUAL,2022-07-07,2024-09,2024-09-30,2023-09-07,ACTUAL,2023-09-07,2023-09-07,ACTUAL,2023-09-07,,INTERVENTIONAL,,,A Study of MK-1088 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-1088-002),A Phase 1/Phase 2 Study to Evaluate the Safety and Tolerability of MK-1088 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors,TERMINATED,,PHASE1/PHASE2,27.0,ACTUAL,Merck Sharp & Dohme LLC,"The decision to close study enrollment was based on review of data from the dose escalation phase and Sponsor prioritization. The decision to stop enrollment was not due to any safety concerns, and there were no safety signals observed during the study.",6.0,,Business Reasons,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,INDUSTRY,,,,,,,2023,0.0
NCT04218123,,2019-12-30,2024-03-28,,2024-06-27,2020-01-02,2020-01-06,ACTUAL,2024-06-20,2024-06-24,ACTUAL,,,,2024-06-27,2024-07-23,ACTUAL,2020-02-05,ACTUAL,2020-02-05,2024-06,2024-06-30,2023-09-14,ACTUAL,2023-09-14,2023-09-13,ACTUAL,2023-09-13,,INTERVENTIONAL,,,Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes,Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes,COMPLETED,,PHASE2/PHASE3,40.0,ACTUAL,Medical University of South Carolina,"This study was designed in 2019 with a power analysis that estimated a 20% placebo response in Meniere's Disease. This was a gross underestimation in hindsight. A systematic review with meta-analysis published in 2023 has illustrated that this effect is much stronger, closer to 50% in patients with Meniere's Disease, which may affect the ability to detect symptomatic differences between venlafaxine and placebo treatment periods, respectively.",2.0,,,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,OTHER,,,,,,,2023,1.0
NCT04418297,,2020-05-28,,,2023-02-28,2020-06-01,2020-06-05,ACTUAL,,,,,,,2023-02-28,2023-03-02,ACTUAL,2020-10-23,ACTUAL,2020-10-23,2022-08,2022-08-31,2022-11-22,ACTUAL,2022-11-22,2022-11-22,ACTUAL,2022-11-22,,INTERVENTIONAL,,,"A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy","A Randomized, Double-Blind, Placebo-Controlled, Sequential, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy",TERMINATED,,PHASE1,23.0,ACTUAL,Celltrion,,2.0,,The termination criteria of the protocol was met during dose escalation,f,,,,,t,f,,,,,,,,,,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,INDUSTRY,,,,,,,2022,0.0
NCT04965688,,2021-07-07,,,2024-10-01,2021-07-07,2021-07-16,ACTUAL,,,,,,,2024-10-01,2024-10-03,ACTUAL,2021-08-08,ACTUAL,2021-08-08,2024-10,2024-10-31,2024-03-13,ACTUAL,2024-03-13,2024-03-13,ACTUAL,2024-03-13,,INTERVENTIONAL,SPOCK,,Systems Biology Guided Therapy for Breast Cancer Positive for Oestrogen Receptor After Aromatase Inhibitor and CDK Inhibition,Systems Biology Guided Therapy for Breast Cancer Positive for Oestrogen Receptor After Aromatase Inhibitor and CDK Inhibition,TERMINATED,,PHASE2,2.0,ACTUAL,Inova Health Care Services,,,,Lack of enrollment to meet the primary and secondary study goals,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,OTHER,,,,,,,2024,0.0
NCT04719832,,2021-01-18,,,2024-07-17,2021-01-18,2021-01-22,ACTUAL,,,,,,,2024-07-17,2024-07-18,ACTUAL,2021-03-17,ACTUAL,2021-03-17,2024-07,2024-07-31,2023-11-21,ACTUAL,2023-11-21,2023-11-21,ACTUAL,2023-11-21,,INTERVENTIONAL,SWIFT-1,,Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype,"A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype",COMPLETED,,PHASE3,395.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2023,1.0
NCT03259165,,2017-08-19,2023-09-04,,2024-07-28,2017-08-19,2017-08-23,ACTUAL,2024-07-28,2024-08-20,ACTUAL,,,,2024-07-28,2024-08-20,ACTUAL,2017-12-14,ACTUAL,2017-12-14,2024-07,2024-07-31,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,N-FURIOUS,,Nitroglycerin vs. Furosemide Using Lung Ultrasound Pilot Trial,Nitroglycerin vs. Furosemide Using Lung Ultrasound Pilot Trial (N-FURIOUS),TERMINATED,,PHASE2,52.0,ACTUAL,Indiana University,"Due to the COVID-19 pandemic, enrollment was halted. The nature of the study was to enroll patients with AHF signs and symptoms. The principle symptom is shortness of breath, a common symptom during the peak of COVID-19. Further, employees were not allowed into the ED setting to enroll patients, when much less was known about COVID-19.",2.0,,"COVID-19 pandemic. Initially had planned to resume study, but ultimately decided to close.",f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,OTHER,,,,,,,2021,0.0
NCT04963270,,2021-07-07,,,2024-10-03,2021-07-07,2021-07-15,ACTUAL,,,,,,,2024-10-03,2024-10-04,ACTUAL,2021-10-19,ACTUAL,2021-10-19,2024-10,2024-10-31,2024-09-02,ACTUAL,2024-09-02,2024-01-29,ACTUAL,2024-01-29,,INTERVENTIONAL,,,"A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis","A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis",COMPLETED,,PHASE3,188.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,INDUSTRY,,,,,,,2024,0.0
NCT03338920,,2017-11-07,2023-06-13,,2023-07-03,2017-11-07,2017-11-09,ACTUAL,2023-07-03,2023-07-24,ACTUAL,,,,2023-07-03,2023-07-24,ACTUAL,2017-11-02,ACTUAL,2017-11-02,2023-06,2023-06-30,2022-04-11,ACTUAL,2022-04-11,2022-04-11,ACTUAL,2022-04-11,,INTERVENTIONAL,,,Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents,"A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of ONZETRA® Xsail® (Sumatriptan Nasal Powder) for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents",TERMINATED,,PHASE3,159.0,ACTUAL,Currax Pharmaceuticals,,2.0,,eDiary data collected not sufficient to utilize in the analysis of protocol endpoints,f,,,,,t,f,,,,,,,,,,,2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,INDUSTRY,,,,,,,2022,0.0
NCT04175509,,2019-11-21,2021-06-04,,2022-01-18,2019-11-22,2019-11-25,ACTUAL,2021-08-18,2021-08-19,ACTUAL,,,,2022-01-18,2022-01-20,ACTUAL,2019-12-23,ACTUAL,2019-12-23,2022-01,2022-01-31,2021-06-01,ACTUAL,2021-06-01,2021-06-01,ACTUAL,2021-06-01,,INTERVENTIONAL,,,Improving Post-Operative Pain and Recovery in Gynecologic Surgery,Improving Post-Operative Pain and Recovery in Gynecologic Surgery,COMPLETED,,PHASE4,40.0,ACTUAL,Aultman Health Foundation,"Due to the COVID-19 pandemic, many patients were prohibited to stay overnight in the hospital. Therefore, many patients were discharged home before 24 hours after surgery. This is primarily why the primary and secondary outcomes were analyzed at shorter time intervals (6 hours post-op and 12 hours-op) as well.",2.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,OTHER,,,,,,,2021,1.0
NCT04979793,,2021-06-16,,,2023-08-14,2021-07-16,2021-07-28,ACTUAL,,,,,,,2023-08-14,2023-08-16,ACTUAL,2021-07-28,ACTUAL,2021-07-28,2023-08,2023-08-31,2024-07-30,ESTIMATED,2024-07-30,2024-07-30,ESTIMATED,2024-07-30,,INTERVENTIONAL,,,Role of L-citrulline in Prevention of Pregnancy Associated Hypertension,Role of L-citrulline in Prevention of Pregnancy Associated Hypertension in Nulliparous Women,SUSPENDED,,PHASE1,338.0,ESTIMATED,"The University of Texas Medical Branch, Galveston",,2.0,,At the request of the PI,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,OTHER,,,,,,,2024,0.0
NCT04806945,,2021-03-17,,,2022-05-01,2021-03-17,2021-03-19,ACTUAL,,,,,,,2022-05-01,2022-05-05,ACTUAL,2022-09-30,ESTIMATED,2022-09-30,2021-03,2021-03-31,2024-10-30,ESTIMATED,2024-10-30,2024-02-15,ESTIMATED,2024-02-15,,INTERVENTIONAL,,,A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer,"A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of First-Line Treatment With HLX10 (Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection) + Chemotherapy (Carboplatin/Cisplatin and Paclitaxel) vs Chemotherapy (Carboplatin/Cisplatin and Paclitaxel)in Patients With Advanced Cervical Cancer",WITHDRAWN,,PHASE3,0.0,ACTUAL,Shanghai Henlius Biotech,,2.0,,The sponsor terminated the trial.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,INDUSTRY,,,,,,,2024,0.0
NCT04584307,,2020-10-06,,,2021-08-18,2020-10-06,2020-10-12,ACTUAL,,,,,,,2021-08-18,2021-08-23,ACTUAL,2021-04,ESTIMATED,2021-04-30,2021-08,2021-08-31,2024-12,ESTIMATED,2024-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,Immuno-POWER,,Phase II Study of Immunomaintenance Using POmalidomide With Elotuzumab afteR Second Autologous Transplant,Phase II Study of Immunomaintenance Using POmalidomide With Elotuzumab afteR Second Autologous Transplant (Immuno-POWER Trial): Big Ten Cancer Research Consortium BTCRC-MM19-428,WITHDRAWN,,PHASE2,0.0,ACTUAL,Big Ten Cancer Research Consortium,,1.0,,Funder pulled support/funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,OTHER,,,,,,,2024,0.0
NCT03176316,,2017-05-31,2024-04-01,,2024-06-27,2017-06-02,2017-06-05,ACTUAL,2024-06-27,2024-07-01,ACTUAL,,,,2024-06-27,2024-07-01,ACTUAL,2017-09-20,ACTUAL,2017-09-20,2024-06,2024-06-30,2020-02-20,ACTUAL,2020-02-20,2020-02-20,ACTUAL,2020-02-20,,INTERVENTIONAL,FusionIleus,,The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus,The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus,TERMINATED,,PHASE4,53.0,ACTUAL,Loyola University,,1.0,,The study was terminated by the Institutional Review Board.,f,,,,f,t,f,,,f,,,,,,NO,There are no plans to share individual participant data with other researchers,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2020,0.0
NCT04248153,,2020-01-28,2024-07-11,,2024-08-22,2020-01-28,2020-01-30,ACTUAL,2024-08-22,2024-08-23,ACTUAL,,,,2024-08-22,2024-08-23,ACTUAL,2019-10-14,ACTUAL,2019-10-14,2024-08,2024-08-31,2021-07-31,ACTUAL,2021-07-31,2020-02-19,ACTUAL,2020-02-19,,INTERVENTIONAL,,"The only participants enrolled in this study were 3 training cases. No other study participant was enrolled in the study; therefore, there are no results for Group A and Group B.",Optimal Timing of BR55 CEUS of the Ovaries,An Exploratory Study to Determine the Optimal Timing of BR55 Contrast Enhanced Ultrasound (CEUS) of the Ovaries in Pre-menopausal Women,TERMINATED,,PHASE2,3.0,ACTUAL,"Bracco Diagnostics, Inc",,2.0,,Sponsor decision; expiration of available study agent due to long recruitment timeline.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,INDUSTRY,,,,,,,2021,0.0
NCT04434378,,2020-06-12,,,2020-06-15,2020-06-15,2020-06-16,ACTUAL,,,,,,,2020-06-15,2020-06-16,ACTUAL,2017-11-16,ACTUAL,2017-11-16,2020-06,2020-06-30,2020-02-05,ACTUAL,2020-02-05,2020-02-05,ACTUAL,2020-02-05,,INTERVENTIONAL,,,Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair,The Use of Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair: A Randomized Double-Blind Placebo-Controlled Study,TERMINATED,,PHASE4,170.0,ACTUAL,"Jewish Hospital, Cincinnati, Ohio",,2.0,,Significant difference not reached on interim analysis,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,OTHER,,,,,,,2020,0.0
NCT03373669,,2017-12-04,,,2021-04-01,2017-12-08,2017-12-14,ACTUAL,,,,,,,2021-04-01,2021-04-05,ACTUAL,2017-11-16,ACTUAL,2017-11-16,2021-04,2021-04-30,2020-12-01,ACTUAL,2020-12-01,2019-10-16,ACTUAL,2019-10-16,,INTERVENTIONAL,,,Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine,Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine,COMPLETED,,PHASE4,120.0,ACTUAL,Johns Hopkins Bloomberg School of Public Health,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,OTHER,,,,,,,2020,1.0
NCT05437848,,2022-02-23,,,2023-11-03,2022-06-23,2022-06-29,ACTUAL,,,,,,,2023-11-03,2023-11-07,ACTUAL,2022-02-25,ACTUAL,2022-02-25,2023-11,2023-11-30,2022-12-12,ACTUAL,2022-12-12,2022-12-12,ACTUAL,2022-12-12,,INTERVENTIONAL,COTA China PK,,Chinese Multiple Dose Escalation (MDE) High Dose Study,"A Phase 1 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Cotadutide in Chinese Overweight/Obese Subjects With Type 2 Diabetes Mellitus",COMPLETED,,PHASE1,16.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,INDUSTRY,,,,,,,2022,0.0
NCT05645887,,2022-11-22,,,2024-07-30,2022-12-01,2022-12-12,ACTUAL,,,,,,,2024-07-30,2024-07-31,ACTUAL,2024-02,ESTIMATED,2024-02-29,2023-07,2023-07-31,2024-05-23,ACTUAL,2024-05-23,2024-05-23,ACTUAL,2024-05-23,,INTERVENTIONAL,ALBUMIM,,Human Albumin Treatment in Adult Septic Shock. A Study Evaluating Immune Response and Organ Failure.,Human Albumin Treatment in Adult Septic Shock. A Study Evaluating Immune Response and Organ Failure.,WITHDRAWN,,PHASE2,0.0,ACTUAL,Albimmune SL,,2.0,,Internal reorganisations and lack of funding by the sponsor,f,,,,t,f,f,,,,,,,,,,,2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,INDUSTRY,,,,,,,2024,0.0
NCT03208179,,2017-06-30,,,2022-06-22,2017-06-30,2017-07-05,ACTUAL,,,,,,,2022-06-22,2022-06-27,ACTUAL,2018-03-29,ACTUAL,2018-03-29,2022-06,2022-06-30,2020-03-15,ACTUAL,2020-03-15,2020-03-15,ACTUAL,2020-03-15,,INTERVENTIONAL,IMPROVE,,Improving PRegnancy Outcomes With Intermittent preVEntive Treatment in Africa,"IPTp With Dihydroartemisinin-piperaquine and Azithromycin for Malaria, Sexually Transmitted and Reproductive Tract Infections in Pregnancy in High Sulphadoxine-pyrimethamine Resistance Areas in Kenya, Malawi and Tanzania",COMPLETED,,PHASE3,4680.0,ACTUAL,Liverpool School of Tropical Medicine,,3.0,,,f,,,,t,f,f,,,,,,No later than 5 years after publication,Open access,,YES,"Individual, de-identified participant data will be made available for meta-analyses as soon as the data analysis is completed, with the understanding that results of the meta-analysis will not be published prior to the results of the individual trial without prior agreement of the investigators. No later than 5 years after the publication of the trial a fully de-identified data set will be available for sharing purposes",2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,OTHER,,,,,,,2020,0.0
NCT03315052,,2017-10-13,,,2019-09-19,2017-10-16,2017-10-19,ACTUAL,,,,,,,2019-09-19,2019-09-23,ACTUAL,2019-01,ESTIMATED,2019-01-31,2019-09,2019-09-30,2022-01,ESTIMATED,2022-01-31,2021-01,ESTIMATED,2021-01-31,,INTERVENTIONAL,BILT,,Budesonide for Immunosuppression After Liver Transplantation to Reduce Side Effects,Budesonide in Liver Transplantation,WITHDRAWN,,PHASE4,0.0,ACTUAL,Montefiore Medical Center,,2.0,,Delay in IRB approval,f,,,,t,t,f,,,t,,,,,,UNDECIDED,Annonymous IPD will be shared in the event that the study protocol is approved at other transplanting institutions who then collaborate in this study. IPD will include standard clinical and laboratory data monitored after liver transplantation,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,OTHER,,,,,,,2022,0.0
NCT02718300,,2016-03-21,2024-01-10,2022-01-12,2024-04-02,2016-03-23,2016-03-24,ESTIMATED,2024-04-02,2024-05-01,ACTUAL,,2024-05-01,ACTUAL,2024-04-02,2024-05-01,ACTUAL,2017-02-08,ACTUAL,2017-02-08,2024-04,2024-04-30,2022-04-29,ACTUAL,2022-04-29,2021-01-28,ACTUAL,2021-01-28,,INTERVENTIONAL,,"Due to early termination of the study, per the Statistical Analysis Plan, participants were combined into arms based on the dosage received regardless of what phase of the study they participated in.",A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis,"A Phase 2 Study of the Safety, Tolerability, and Efficacy of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis",TERMINATED,,PHASE2,74.0,ACTUAL,Incyte Corporation,,4.0,,A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.,t,,,,f,t,f,,,,,,,,,,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,NCT03147742,APPROVED_FOR_MARKETING,,,,2022,0.0
NCT04650854,,2020-11-05,,,2024-02-23,2020-11-24,2020-12-03,ACTUAL,,,,,,,2024-02-23,2024-02-26,ACTUAL,2021-02-03,ACTUAL,2021-02-03,2024-02,2024-02-29,2024-01-25,ACTUAL,2024-01-25,2024-01-25,ACTUAL,2024-01-25,,INTERVENTIONAL,,,A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis,An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis,COMPLETED,,PHASE3,165.0,ACTUAL,UCB Pharma,,2.0,,,f,,,,t,t,f,,,t,,,"Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",http://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2024,1.0
NCT02775903,,2016-05-16,2019-10-30,,2023-02-01,2016-05-16,2016-05-18,ESTIMATED,2020-04-22,2020-05-04,ACTUAL,,,,2023-02-01,2023-02-28,ACTUAL,2016-06-03,ACTUAL,2016-06-03,2023-02,2023-02-28,2021-12-27,ACTUAL,2021-12-27,2018-12-31,ACTUAL,2018-12-31,,INTERVENTIONAL,,All randomized participants (intent-to-treat population),An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML),"A Randomized, Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 Years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT)",COMPLETED,,PHASE2,213.0,ACTUAL,Celgene,"Protocol Amendment 03 was introduced on 05 Mar 2019. At the Investigator's discretion, participants meeting all the continuation criteria were eligible to enter the optional extension phase to continue to benefit from treatment with subcutaneous azacitidine and/or durvalumab. Participants started the extension phase at the time of their next regularly scheduled dosing cycle for study drug azacitidine or azacitidine and durvalumab.",2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2021,1.0
NCT04074837,,2019-08-27,,,2023-02-15,2019-08-28,2019-08-30,ACTUAL,,,,,,,2023-02-15,2023-02-17,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2020-05,2020-05-31,2021-08-15,ACTUAL,2021-08-15,2021-07-31,ACTUAL,2021-07-31,,INTERVENTIONAL,,,"Phase1a, Dose-escalation Study of NNI-362 in Healthy Aged Volunteers","Phase1a, Randomized Placebo-controlled, Single and Multiple Dose, Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNI-362 in Healthy Aged Volunteers 50 to 72 Years of Age",COMPLETED,,PHASE1,56.0,ACTUAL,"Neuronascent, Inc.",,6.0,,,f,,,,t,t,f,,,,,,,,,NO,This clinical trial will be available for peer-reviewed publication.,2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,INDUSTRY,,,,,,,2021,1.0
NCT02793128,,2016-05-29,2020-09-30,,2020-12-01,2016-06-07,2016-06-08,ESTIMATED,2020-10-28,2020-11-20,ACTUAL,,,,2020-12-01,2020-12-22,ACTUAL,2017-04-04,ACTUAL,2017-04-04,2020-12,2020-12-31,2020-03-05,ACTUAL,2020-03-05,2019-04-05,ACTUAL,2019-04-05,,INTERVENTIONAL,Olympus,,The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study,A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of UGN-101 on Ablation of Upper Urinary Tract Urothelial Carcinoma,COMPLETED,,PHASE3,71.0,ACTUAL,UroGen Pharma Ltd.,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2020,1.0
NCT04836494,,2021-03-29,,,2023-12-20,2021-04-05,2021-04-08,ACTUAL,,,,,,,2023-12-20,2023-12-21,ACTUAL,2021-03-25,ACTUAL,2021-03-25,2023-12,2023-12-31,2023-11-20,ACTUAL,2023-11-20,2023-11-20,ACTUAL,2023-11-20,,INTERVENTIONAL,,,"A First in Human, Dose Escalation Study to Evaluate the Safety and Tolerability of BBP-671 in Healthy Volunteers and Patients With Propionic Acidemia or Methylmalonic Acidemia","A First-in-human, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Escalation to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBP-671 in Healthy Subjects and In Patients With Propionic Acidemia or Methylmalonic Acidemia",TERMINATED,,PHASE1,79.0,ACTUAL,"CoA Therapeutics, Inc., a BridgeBio company",,6.0,,Slow recruitment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 16:07:06.331272,2024-10-16 16:07:06.331272,INDUSTRY,,,,,,,2023,0.0
NCT03671590,,2018-09-12,,,2024-07-18,2018-09-12,2018-09-14,ACTUAL,,,,,,,2024-07-18,2024-07-19,ACTUAL,2018-09-10,ACTUAL,2018-09-10,2024-07,2024-07-31,2024-05-21,ACTUAL,2024-05-21,2024-05-21,ACTUAL,2024-05-21,,INTERVENTIONAL,,,"Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies","A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies",TERMINATED,,PHASE1,172.0,ACTUAL,"TG Therapeutics, Inc.",,3.0,,Strategic/Business Decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2024,0.0
NCT04199598,,2019-12-12,,,2020-04-20,2019-12-12,2019-12-16,ACTUAL,,,,,,,2020-04-20,2020-04-21,ACTUAL,2020-01-28,ACTUAL,2020-01-28,2020-04,2020-04-30,2020-04-03,ACTUAL,2020-04-03,2020-04-03,ACTUAL,2020-04-03,,INTERVENTIONAL,,,Relative Bioavailability Study With Abediterol Administered Via Three Different Inhalation Devices in Healthy Volunteers.,"An Open-label, Single-center, Randomized, 4-period, Single Dose, Crossover Study to Assess the Relative Bioavailability of Abediterol Inhaled Via Two Different Nebulizers and Via Dry Powder Inhaler in Healthy Subjects.",TERMINATED,,PHASE1,25.0,ACTUAL,AstraZeneca,,4.0,,The decision to terminate has been taken by the Sponsor. The decision is not due to safety concerns but reflects business prioritizations of the company.,f,,,,f,f,f,,,f,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2020,0.0
NCT03800472,,2019-01-03,,,2020-03-18,2019-01-10,2019-01-11,ACTUAL,,,,,,,2020-03-18,2020-03-19,ACTUAL,2019-01-15,ACTUAL,2019-01-15,2020-03,2020-03-31,2020-03-10,ACTUAL,2020-03-10,2020-03-10,ACTUAL,2020-03-10,,INTERVENTIONAL,,,"A Study Investigating the Safety, Absorption and Elimination of GLPG3312, a New Drug in the Treatment of Inflammatory Diseases","A Phase I, Randomized, Double-blind, Placebo-controlled, Single-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Including the Effect of Food, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG3312, in Adult, Healthy Subjects",COMPLETED,,PHASE1,95.0,ACTUAL,Galapagos NV,,9.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2020,1.0
NCT04745832,,2021-02-04,2023-10-02,,2023-11-20,2021-02-04,2021-02-09,ACTUAL,2023-11-20,2023-12-13,ACTUAL,,,,2023-11-20,2023-12-13,ACTUAL,2021-08-13,ACTUAL,2021-08-13,2022-12,2022-12-31,2023-03-20,ACTUAL,2023-03-20,2023-03-20,ACTUAL,2023-03-20,,INTERVENTIONAL,,,Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL),"A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME- 401) in Combination With Rituximab Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non Hodgkin's Lymphoma (iNHL) - The COASTAL Study",TERMINATED,,PHASE3,82.0,ACTUAL,"MEI Pharma, Inc.",,2.0,,Discontinuation of zandelisib program,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,INDUSTRY,,,,,,,2023,0.0
NCT02846376,,2016-06-24,,,2024-02-16,2016-07-26,2016-07-27,ESTIMATED,,,,,,,2024-02-16,2024-02-20,ACTUAL,2019-03-08,ACTUAL,2019-03-08,2024-02,2024-02-29,2023-12-21,ACTUAL,2023-12-21,2023-12-21,ACTUAL,2023-12-21,,INTERVENTIONAL,CPIT-002,,Single Agent and Combined Inhibition After Allogeneic Stem Cell Transplant,Phase I Study of Single-agent and Combined Checkpoint Inhibition After Allogeneic Hematopoietic Stem Cell Transplantation in Patients at High Risk for Post-transplant Recurrence,TERMINATED,,PHASE1,8.0,ACTUAL,Hackensack Meridian Health,,3.0,,Lack of Enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,OTHER,,,,,,,2023,0.0
NCT02593045,,2015-10-29,,,2021-01-19,2015-10-29,2015-10-30,ESTIMATED,,,,,,,2021-01-19,2021-01-20,ACTUAL,2015-10,,2015-10-31,2019-02,2019-02-28,2020-04,ACTUAL,2020-04-30,2020-04,ACTUAL,2020-04-30,,INTERVENTIONAL,,,Study of IPH4102 in Patients With Relapsed/Refractory Cutaneous T-cell Lymphomas (CTCL),"Open Label, Multicenter Phase I Study of IPH4102, a Humanized Anti-KIR3DL2 Monoclonal Antibody, in Patients With Relapsed/Refractory Cutaneous T-cell Lymphomas (CTCL)",COMPLETED,,PHASE1,44.0,ACTUAL,Innate Pharma,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2020,1.0
NCT04854642,,2021-04-15,2021-11-05,,2023-12-21,2021-04-20,2021-04-22,ACTUAL,2021-11-05,2022-01-11,ACTUAL,,,,2023-12-21,2024-01-17,ACTUAL,2020-10-20,ACTUAL,2020-10-20,2023-12,2023-12-31,2020-12-09,ACTUAL,2020-12-09,2020-12-09,ACTUAL,2020-12-09,,INTERVENTIONAL,,"Enrolled set: all enrolled subjects. This analysis set was used for demographic, baseline and background characteristics",A Single Dose Study About the Influence of Food on the Oral Bioavailability of Ladarixin Capsule in Healthy Volunteers,"Influence of Food on the Oral Bioavailability of Ladarixin 200 mg Capsule in Healthy Volunteers of Both Sexes. A Single Dose (400 mg), Randomized, Open Label, Two-Way Crossover Study",COMPLETED,,PHASE1,36.0,ACTUAL,Dompé Farmaceutici S.p.A,Limitations and Caveats not specified.,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2020,1.0
NCT04950114,,2021-06-25,,,2022-11-10,2021-06-25,2021-07-06,ACTUAL,,,,,,,2022-11-10,2022-11-15,ACTUAL,2021-07-27,ACTUAL,2021-07-27,2022-11,2022-11-30,2022-11-02,ACTUAL,2022-11-02,2022-11-02,ACTUAL,2022-11-02,,INTERVENTIONAL,,,"An Open-Label, Long-term Study of GFB-887 in Patients With Glomerular Kidney Diseases","An Open-Label, Long-term Study of GFB-887 in Patients With Glomerular Kidney Diseases",TERMINATED,,PHASE2,31.0,ACTUAL,"Goldfinch Bio, Inc.",,1.0,,Business reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2022,0.0
NCT04470908,,2020-07-10,2023-03-10,,2023-03-10,2020-07-10,2020-07-14,ACTUAL,2023-03-10,2023-12-14,ACTUAL,,,,2023-03-10,2023-12-14,ACTUAL,2020-07-29,ACTUAL,2020-07-29,2023-03,2023-03-31,2020-11-10,ACTUAL,2020-11-10,2020-11-10,ACTUAL,2020-11-10,,INTERVENTIONAL,,,The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males,"A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effect of the Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Male Subjects",COMPLETED,,PHASE1,13.0,ACTUAL,BeiGene,,1.0,,,f,,,,f,t,f,,,,,,,,,YES,,2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,INDUSTRY,,,,,,,2020,1.0
NCT05708690,,2023-01-09,,,2023-01-31,2023-01-31,2023-02-01,ACTUAL,,,,,,,2023-01-31,2023-02-01,ACTUAL,2022-10-01,ACTUAL,2022-10-01,2023-01,2023-01-31,2023-01-06,ACTUAL,2023-01-06,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,Topical Effect of Tranexamic Acid in Postoperative Bleeding and Blood Products Transfusion After Cardiac Surgery,Topical Application Effect of Tranexamic Acid in Postoperative Bleeding and Blood Products Transfusion After Cardiac Surgery,COMPLETED,,PHASE4,132.0,ACTUAL,Indonesia University,,2.0,,,f,,,,f,f,f,,,,,,"January 6, 2022 for 2 (two) years",for peer-reviewing or for further analysis or when needed by authors of a systematic review/meta analysis of randomized controlled trials,,YES,"the study protocol, ethical clearance letter, the primary database of the study, as well as the study's analysis plan and the manuscript of the study will be made available on the permission by the grant provider and ethical committee",2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,OTHER,,,,,,,2023,1.0
NCT04080076,,2019-06-28,,,2022-09-20,2019-09-03,2019-09-06,ACTUAL,,,,,,,2022-09-20,2022-09-22,ACTUAL,2019-01-12,ACTUAL,2019-01-12,2022-09,2022-09-30,2024-09-06,ESTIMATED,2024-09-06,2024-09-06,ESTIMATED,2024-09-06,,INTERVENTIONAL,FACT,,Comparative and Efficacy Study of ACTHar Gel Alone or in Combination With Tacrolimus in Fibrillary Glomerulopathy,A Multicenter Comparative and Efficacy Study of ACTHar Gel Alone or in Combination With Tacrolimus in Fibrillary Glomerulopathy,WITHDRAWN,,PHASE4,0.0,ACTUAL,"NephroNet, Inc.",,2.0,,Study was updated and issued a new NCT number.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,OTHER,,,,,,,2024,0.0
NCT04231318,,2020-01-14,2023-06-15,,2023-07-20,2020-01-14,2020-01-18,ACTUAL,2023-07-20,2023-08-09,ACTUAL,,,,2023-07-20,2023-08-09,ACTUAL,2020-09-11,ACTUAL,2020-09-11,2023-06,2023-06-30,2022-05-16,ACTUAL,2022-05-16,2022-05-16,ACTUAL,2022-05-16,,INTERVENTIONAL,,,Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain,"A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal®) to Provide Symptomatic Relief of Osteoarthritis of the Knee",COMPLETED,,PHASE3,231.0,ACTUAL,"Anika Therapeutics, Inc.",There were no limitations or caveats associated with the conduct of this trial.,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2022,1.0
NCT03126812,,2016-12-19,,,2024-05-28,2017-04-19,2017-04-24,ACTUAL,,,,,,,2024-05-28,2024-05-29,ACTUAL,2017-11-01,ACTUAL,2017-11-01,2024-05,2024-05-31,2024-03-05,ACTUAL,2024-03-05,2023-06-01,ACTUAL,2023-06-01,,INTERVENTIONAL,,,Neo-adjuvant Pembrolizumab in Primary Stage IV Ovarian Cancer,"Feasibility Study of Neo-adjuvant Treatment With Carboplatin, Paclitaxel and Pembrolizumab in Primary Stage IV Serous Ovarian Cancer",COMPLETED,,PHASE1/PHASE2,33.0,ACTUAL,The Netherlands Cancer Institute,,1.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,to be determinated,2024-10-15 17:51:08.617379,2024-10-15 17:51:08.617379,OTHER,,,,,,,2024,1.0
NCT02876640,,2016-08-19,2024-03-07,2023-05-31,2024-05-22,2016-08-19,2016-08-24,ESTIMATED,2024-05-20,2024-05-22,ACTUAL,,2023-06-18,ACTUAL,2024-05-22,2024-06-18,ACTUAL,2018-03-16,ACTUAL,2018-03-16,2023-12,2023-12-31,2022-06-03,ACTUAL,2022-06-03,2022-06-03,ACTUAL,2022-06-03,,INTERVENTIONAL,,,Retinoid 9cUAB30 in Producing a Biologic Effect in Patients With Early Stage Breast Cancer,Phase Ib 9cUAB30 in Early Stage Breast Cancer to Evaluate Biologic Effect,TERMINATED,,PHASE1,27.0,ACTUAL,National Cancer Institute (NCI),,1.0,,Inadequate Accrual Rate,f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,NIH,,,,,,,2022,0.0
NCT04698850,,2021-01-05,,,2022-08-07,2021-01-05,2021-01-07,ACTUAL,,,,,,,2022-08-07,2022-08-10,ACTUAL,2021-01-04,ESTIMATED,2021-01-04,2022-08,2022-08-31,2023-06,ESTIMATED,2023-06-30,2023-01,ESTIMATED,2023-01-31,,INTERVENTIONAL,BEY-RAP,,Brolucizumab vs. Aflibercept for Retinal Angiomatous Proliferation,Brolucizumab vs. Aflibercept for Retinal Angiomatous Proliferation - Prospective Randomised Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,Faculty Hospital Kralovske Vinohrady,,2.0,,funding issues,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,OTHER_GOV,,,,,,,2023,0.0
NCT04352205,,2020-04-07,,,2024-06-28,2020-04-15,2020-04-20,ACTUAL,,,,,,,2024-06-28,2024-07-01,ACTUAL,2020-05-07,ACTUAL,2020-05-07,2024-06,2024-06-30,2024-01-19,ACTUAL,2024-01-19,2024-01-19,ACTUAL,2024-01-19,,INTERVENTIONAL,,,Daratumumab-Based Therapy for the Treatment of Newly Diagnosed Multiple Myeloma With Kidney Failure,A Phase 2 Evaluation of Daratumumab-Based Treatment in Newly Diagnosed Multiple Myeloma Patients With Renal Insufficiency,TERMINATED,,PHASE2,17.0,ACTUAL,Emory University,,1.0,,Slow accrual,f,,,,t,t,f,,,f,,,,,,NO,"Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.",2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,OTHER,,,,,,,2024,0.0
NCT04250311,,2020-01-29,,,2023-08-15,2020-01-29,2020-01-31,ACTUAL,,,,,,,2023-08-15,2023-08-18,ACTUAL,2019-12-12,ACTUAL,2019-12-12,2023-08,2023-08-31,2024-12,ESTIMATED,2024-12-31,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Clinical Trial of Efficacy and Safety of ММН-407 in the Treatment of Influenza in Outpatient Adults,"A Multicenter, Placebo-controlled, Double-blind, Randomized Clinical Trial in Parallel Groups to Evaluate the Efficacy and Safety of ММН-407 in the Treatment of Influenza in Outpatient Adults",SUSPENDED,,PHASE3,314.0,ESTIMATED,Materia Medica Holding,,2.0,,"Due to the end of the ARVI and influenza season, it was suspended until approximately October 01, 2023",f,,,,,f,f,,,,,,,,,,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2024,0.0
NCT02353143,,2015-01-14,2023-06-19,,2024-03-12,2015-01-28,2015-02-02,ESTIMATED,2024-03-12,2024-08-12,ACTUAL,,,,2024-03-12,2024-08-12,ACTUAL,2014-12,ACTUAL,2014-12-31,2024-03,2024-03-31,2021-04-09,ACTUAL,2021-04-09,2021-04-09,ACTUAL,2021-04-09,,INTERVENTIONAL,ARMY,,Study of MEN1112 Intravenous Infusion in Relapsed or Refractory Acute Myeloid Leukemia,"First in Man Study With MEN1112, a CD157 Targeted Monoclonal Antibody, in Relapsed or Refractory Acute Myeloid Leukemia.",TERMINATED,,PHASE1,71.0,ACTUAL,Menarini Group,Study terminated due to any clinical objective response observed in the patients' study population and under the study procedures implemented in the trial,1.0,,The Sponsor accepted the iDSMB recommendation to terminate the study due to evidence of unpredictable liver toxicity and meaningful target engagement not translating into any clinical objective response.,f,,,,t,,,,,,,,,,,,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2021,0.0
NCT04230720,,2020-01-14,,,2021-06-16,2020-01-14,2020-01-18,ACTUAL,,,,,,,2021-06-16,2021-06-22,ACTUAL,2021-04,ESTIMATED,2021-04-30,2021-06,2021-06-30,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Effect of Artificial Tears on Biometry,Impact of Lubrication With Artificial Tears on Biometry Measurements for Cataract Surgery,WITHDRAWN,,PHASE4,0.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,Stopped due to COVID-19.,f,,,,,f,f,,,f,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,OTHER,,,,,,,2021,0.0
NCT03718299,,2018-10-15,2022-10-31,,2023-01-27,2018-10-23,2018-10-24,ACTUAL,2023-01-27,2023-02-23,ACTUAL,,,,2023-01-27,2023-02-23,ACTUAL,2019-07-16,ACTUAL,2019-07-16,2022-08,2022-08-31,2021-11-05,ACTUAL,2021-11-05,2021-11-02,ACTUAL,2021-11-02,,INTERVENTIONAL,,,A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis,"An Open-Label, Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Moderate to Severe Plaque Psoriasis",COMPLETED,,PHASE4,55.0,ACTUAL,Sun Pharmaceutical Industries Limited,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2021,1.0
NCT03348462,,2017-10-30,,,2020-03-07,2017-11-17,2017-11-21,ACTUAL,,,,,,,2020-03-07,2020-03-10,ACTUAL,2017-11-30,ACTUAL,2017-11-30,2020-03,2020-03-31,2020-01-15,ACTUAL,2020-01-15,2019-12-30,ACTUAL,2019-12-30,,INTERVENTIONAL,,,Formulation and Clinical Evaluation of Ethosomal and Liposomal Preparations of Anthralin in Psoriasis,Formulation and Clinical Evaluation of Ethosomal and Liposomal Preparations of Anthralin in Psoriasis,COMPLETED,,PHASE4,20.0,ACTUAL,Assiut University,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,OTHER,,,,,,,2020,1.0
NCT03923478,,2019-04-15,,,2021-03-17,2019-04-17,2019-04-22,ACTUAL,,,,,,,2021-03-17,2021-03-19,ACTUAL,2019-06-24,ACTUAL,2019-06-24,2021-03,2021-03-31,2021-01-20,ACTUAL,2021-01-20,2021-01-20,ACTUAL,2021-01-20,,INTERVENTIONAL,,,ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis,"A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 1b Study to Evaluate the Safety, Efficacy and Mircobiological Response of Oral ABI-M201 in Subjects With Mildly-to-Moderately Active UC With Ongoing Mesalamine Treatment",TERMINATED,,PHASE1,15.0,ACTUAL,Assembly Biosciences,,2.0,,Sponsor Decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,INDUSTRY,,,,,,,2021,0.0
NCT02526329,,2015-08-14,,,2023-11-20,2015-08-14,2015-08-18,ESTIMATED,,,,,,,2023-11-20,2023-11-22,ACTUAL,2015-08-06,ACTUAL,2015-08-06,2023-11,2023-11-30,2023-06,ESTIMATED,2023-06-30,2022-11,ESTIMATED,2022-11-30,,INTERVENTIONAL,,,Donor Regulatory T Cells in Treating Patients With Visceral Acute Graft-versus-Host Disease After Stem Cell Transplant,A Phase 1 Single Center Safety and Feasibility Study of Primary T Regulatory Cell Therapy to Treat Visceral Acute Graft-versus-Host Disease Following Hematopoietic Cell Transplantation,WITHDRAWN,,PHASE1,0.0,ACTUAL,Stanford University,,1.0,,Logistics,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:24:10.527492,2024-10-15 07:24:10.527492,OTHER,,,,,,,2023,0.0
NCT03721679,,2018-10-01,,,2021-01-27,2018-10-24,2018-10-26,ACTUAL,,,,,,,2021-01-27,2021-02-01,ACTUAL,2018-09-25,ACTUAL,2018-09-25,2020-12,2020-12-31,2021-01-26,ACTUAL,2021-01-26,2021-01-26,ACTUAL,2021-01-26,,INTERVENTIONAL,,,Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1,Poly-ICLC (Hiltonol®) Plus Anti-PD1 or Anti-PD-L1 in Unresectable Solid Cancers An Adaptive Phase I/II Clinical Pilot Study,TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,"Oncovir, Inc.",,1.0,,Recruiting target patients is intermittent making it impracticable to enroll the required study sample. The administrative responsibilities have been met with extraordinary challenges. Current funding does not match the incurring costs.,,,,,,t,f,,,,,,,,,NO,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,INDUSTRY,,,,,,,2021,0.0
NCT03000127,,2016-12-17,,,2019-11-04,2016-12-17,2016-12-21,ESTIMATED,,,,,,,2019-11-04,2019-11-06,ACTUAL,2018-07-01,ESTIMATED,2018-07-01,2019-11,2019-11-30,2024-01-01,ESTIMATED,2024-01-01,2023-06-30,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,Testosterone for Fatigue in Men With MS,A Pilot Trial of Testosterone Treatment for Fatigue in Men With Multiple Sclerosis,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, Los Angeles",,1.0,,Lack of funding,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,OTHER,,,,,,,2024,0.0
NCT03738111,,2018-11-01,,,2019-09-23,2018-11-08,2018-11-13,ACTUAL,,,,,,,2019-09-23,2019-09-25,ACTUAL,2018-12,ESTIMATED,2018-12-31,2019-09,2019-09-30,2021-12,ESTIMATED,2021-12-31,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,,,Study of TG02 Citrate in Patients With Advanced Hepatocellular Carcinoma,A Phase 1 Dose-Escalation and Pharmacokinetic Study of TG02 Citrate in Patients With Advanced Hepatocellular Carcinoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,Lee's Pharmaceutical Limited,,1.0,,Sponsor's commercial decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 17:51:08.617379,2024-10-15 17:51:08.617379,INDUSTRY,,,,,,,2021,0.0
NCT04286529,,2020-02-25,2021-12-13,,2022-02-17,2020-02-26,2020-02-27,ACTUAL,2022-02-17,2022-04-18,ACTUAL,,,,2022-02-17,2022-04-18,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2022-02,2022-02-28,2021-05-28,ACTUAL,2021-05-28,2021-05-28,ACTUAL,2021-05-28,,INTERVENTIONAL,,,"Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons","Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons",TERMINATED,,PHASE1,17.0,ACTUAL,Mayo Clinic,,4.0,,Difficulty with study logistics due to COVID-19,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 17:51:08.617379,2024-10-15 17:51:08.617379,OTHER,,,,,,,2021,0.0
NCT03670030,,2018-09-12,2021-04-23,,2021-05-17,2018-09-12,2018-09-13,ACTUAL,2021-05-17,2021-06-10,ACTUAL,,,,2021-05-17,2021-06-10,ACTUAL,2018-11-05,ACTUAL,2018-11-05,2021-05,2021-05-31,2021-02-26,ACTUAL,2021-02-26,2021-01-01,ACTUAL,2021-01-01,,INTERVENTIONAL,,,"A Study to testABI-009 in Patients With Metastatic, Unresectable, Low or Intermediate Grade Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System","A Pilot Phase 2 Study of Albumin-bound Rapamycin Nanoparticles, ABI-009, in Patients With Metastatic, Unresectable, Low or Intermediate Grade Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System",TERMINATED,,PHASE2,5.0,ACTUAL,Ochsner Health System,Early termination leading to small numbers affecting usefulness interpreting results. Only 2 patients were eligible for analysis of primary outcome.,1.0,,Slow enrollment,f,,,,f,t,f,,,,,,,,,NO,Only aggregate data will be made publicly available in the form of poster presentations or journal articles.,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2021,0.0
NCT01553149,,2012-03-10,2021-08-11,,2024-06-06,2012-03-10,2012-03-14,ESTIMATED,2021-11-04,2021-11-30,ACTUAL,,,,2024-06-06,2024-07-03,ACTUAL,2012-07-05,ACTUAL,2012-07-05,2024-06,2024-06-30,2023-12-31,ACTUAL,2023-12-31,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,"Low-Dose or High-Dose Lenalidomide in Treating Younger Patients With Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma","A Phase II Randomized Trial of Lenalidomide (NSC # 703813) in Pediatric Patients With Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas",COMPLETED,,PHASE2,75.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,NIH,,,,,,,2023,1.0
NCT03546907,,2018-05-17,2022-09-23,2020-09-28,2022-10-28,2018-06-04,2018-06-06,ACTUAL,2022-10-28,2022-11-22,ACTUAL,2022-10-28,2022-11-22,ACTUAL,2022-10-28,2022-11-22,ACTUAL,2018-07-16,ACTUAL,2018-07-16,2022-10,2022-10-31,2020-02-21,ACTUAL,2020-02-21,2019-10-03,ACTUAL,2019-10-03,,INTERVENTIONAL,,Randomized population included any participant who had signed informed consent and had been allocated to a randomized treatment regardless of whether the treatment kit was used.,"Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of SAR440340 (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)","A Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of SAR440340, in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)",COMPLETED,,PHASE2,343.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 17:51:08.617379,2024-10-15 17:51:08.617379,INDUSTRY,,,,,,,2020,1.0
NCT03435640,,2018-02-06,2022-11-30,,2023-02-08,2018-02-09,2018-02-19,ACTUAL,2023-02-08,2023-03-08,ACTUAL,,,,2023-02-08,2023-03-08,ACTUAL,2018-03-15,ACTUAL,2018-03-15,2023-02,2023-02-28,2022-05-09,ACTUAL,2022-05-09,2022-05-09,ACTUAL,2022-05-09,,INTERVENTIONAL,REVEAL,,REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies,"A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-262 in Combination With Bempegaldesleukin (NKTR-214) With or Without Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumor Malignancies",TERMINATED,,PHASE1/PHASE2,64.0,ACTUAL,Nektar Therapeutics,,1.0,,Based on the overall results from the Phase 1 part of the study the sponsor decided to end the study. The decision was not due to safety reasons.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,INDUSTRY,,,,,,,2022,0.0
NCT04084678,,2019-09-06,,2023-10-19,2023-10-19,2019-09-06,2019-09-10,ACTUAL,,,,,2023-10-24,ACTUAL,2023-10-19,2023-10-24,ACTUAL,2021-01-20,ACTUAL,2021-01-20,2023-10,2023-10-31,2023-04-12,ACTUAL,2023-04-12,2023-04-12,ACTUAL,2023-04-12,,INTERVENTIONAL,CAPACITY,,A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH,"A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by CPET in Subjects With WHO Group 1 Pulmonary Hypertension Who Recently Initiated Therapy",TERMINATED,,PHASE3,10.0,ACTUAL,United Therapeutics,,2.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,INDUSTRY,,,,,,,2023,0.0
NCT05016284,,2021-08-17,,,2022-12-15,2021-08-17,2021-08-23,ACTUAL,,,,,,,2022-12-15,2022-12-19,ACTUAL,2022-11-24,ACTUAL,2022-11-24,2022-11,2022-11-30,2022-12-15,ACTUAL,2022-12-15,2022-12-15,ACTUAL,2022-12-15,,INTERVENTIONAL,,,Comparison of JW-100 and EUCRISA for the Treatment of Atopic Dermatitis,"A Double-blind, Superiority, and Randomized Controlled Trial to Evaluate the Efficacy of a Novel Cannabidiol Cream for Treatment of Atopic Dermatitis",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Applied Biology, Inc.",,2.0,,Lack of funding,f,,,,,f,f,,,,,,,,,NO,Data will not be shared,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,INDUSTRY,,,,,,,2022,0.0
NCT04392362,,2020-04-21,2021-05-06,,2021-06-03,2020-05-12,2020-05-18,ACTUAL,2021-06-03,2021-06-25,ACTUAL,,,,2021-06-03,2021-06-25,ACTUAL,2018-04-01,ACTUAL,2018-04-01,2021-06,2021-06-30,2020-12-16,ACTUAL,2020-12-16,2020-12-16,ACTUAL,2020-12-16,,INTERVENTIONAL,AHAvsSIM,,A Trial to Compare American Heart Association (AHA) and Simple (SIM)Method to Give Adenosine to Treat Supra-ventricular Tachycardia (SVT),A Randomised Controlled Trial of the Standard Versus a Simplified Adenosine Administration Method in the Treatment of Adult Patients With Supra- Ventricular Tachycardia (SVT),COMPLETED,,PHASE3,30.0,ACTUAL,University of Pretoria,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,OTHER,,,,,,,2020,1.0
NCT04793399,,2021-01-19,2022-11-17,,2024-03-13,2021-03-08,2021-03-11,ACTUAL,2024-03-06,2024-03-12,ACTUAL,,,,2024-03-13,2024-03-19,ACTUAL,2021-02-24,ACTUAL,2021-02-24,2024-02,2024-02-29,2021-09-24,ACTUAL,2021-09-24,2021-09-24,ACTUAL,2021-09-24,,INTERVENTIONAL,,,Safety and Efficacy Evaluation of Bosutinib Plus Atezolizumab in Newly Diagnosed Chronic Leukemia Adult Patients,"Multicenter, Open-label, Phase Ib/II Trial to Evaluate Safety and Efficacy for the Combination of Bosutinib Plus Atezolizumab in Newly Diagnosed Chronic Myeloid Leukemia Patients",TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,Fundacion Espanola para la Curacion de la Leucemia Mieloide Cronica,,1.0,,The study has been prematurely terminated due to the onset of 2 dose limiting toxicities in 2 patients.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2021,0.0
NCT02230527,,2014-08-26,2021-06-15,,2021-06-15,2014-08-28,2014-09-03,ESTIMATED,2021-06-15,2021-07-07,ACTUAL,,,,2021-06-15,2021-07-07,ACTUAL,2014-10,ACTUAL,2014-10-31,2021-06,2021-06-30,2020-05,ACTUAL,2020-05-31,2020-05,ACTUAL,2020-05-31,,INTERVENTIONAL,,,Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia,Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia,TERMINATED,,PHASE2/PHASE3,46.0,ACTUAL,The Cleveland Clinic,,2.0,,Lack of enrollment,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,OTHER,,,,,,,2020,0.0
NCT05038904,,2021-08-26,2023-08-29,,2023-09-27,2021-09-02,2021-09-09,ACTUAL,2023-09-27,2023-09-28,ACTUAL,,,,2023-09-27,2023-09-28,ACTUAL,2021-12-16,ACTUAL,2021-12-16,2023-09,2023-09-30,2022-12-31,ACTUAL,2022-12-31,2022-12-08,ACTUAL,2022-12-08,,INTERVENTIONAL,,,Preventing Anaphylaxis With Acalabrutinib,"Preventing Life-Threatening Allergic Reactions With Acalabrutinib, an FDA-Approved Bruton's Tyrosine Kinase Inhibitor",COMPLETED,,PHASE2,10.0,ACTUAL,Johns Hopkins University,"Limitations included a small patient population, the lack of fully blinded oral food challenges, and the lack of placebo treatment arm. Additionally, this trial did not investigate alternative durations or dosages of acalabrutinib; therefore, the minimum effective duration and dose are as yet undetermined.",1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,OTHER,,,,,,,2022,1.0
NCT03105219,,2017-04-03,,,2020-11-05,2017-04-03,2017-04-07,ACTUAL,,,,,,,2020-11-05,2020-11-09,ACTUAL,2017-07-01,ESTIMATED,2017-07-01,2020-11,2020-11-30,2021-05-30,ESTIMATED,2021-05-30,2021-05-30,ESTIMATED,2021-05-30,,INTERVENTIONAL,BENCH,,IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease,IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease,WITHDRAWN,,PHASE3,0.0,ACTUAL,"Nanjing First Hospital, Nanjing Medical University",,2.0,,Shortfall in funding,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 17:51:08.617379,2024-10-15 17:51:08.617379,OTHER,,,,,,,2021,0.0
NCT04459767,,2020-07-01,,,2020-12-18,2020-07-01,2020-07-07,ACTUAL,,,,,,,2020-12-18,2020-12-22,ACTUAL,2020-08-06,ACTUAL,2020-08-06,2020-12,2020-12-31,2020-12-15,ACTUAL,2020-12-15,2020-12-15,ACTUAL,2020-12-15,,INTERVENTIONAL,,,"Investigation Of Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Doses Of Vupanorsen In Japanese Healthy Adult Participants With Elevated Triglycerides","A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED, SINGLE ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-07285557 (VUPANORSEN) ADMINISTERED SUBCUTANEOUSLY IN JAPANESE HEALTHY ADULTS WITH ELEVATED TRIGLYCERIDES",COMPLETED,,PHASE1,12.0,ACTUAL,Pfizer,,3.0,,,f,,,,f,t,f,,,t,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,INDUSTRY,,,,,,,2020,1.0
NCT03684785,,2018-09-19,,,2022-03-30,2018-09-24,2018-09-26,ACTUAL,,,,,,,2022-03-30,2022-04-07,ACTUAL,2018-12-13,ACTUAL,2018-12-13,2022-03,2022-03-31,2022-03-30,ACTUAL,2022-03-30,2022-03-30,ACTUAL,2022-03-30,,INTERVENTIONAL,,,"Intratumoral Cavrotolimod Combined With Pembrolizumab or Cemiplimab in Patients With Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors","Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors: A Phase 1b/2 Study of Cavrotolimod Combined With Pembrolizumab or Cemiplimab",TERMINATED,,PHASE1/PHASE2,57.0,ACTUAL,"Exicure, Inc.",,7.0,,The study was canceled for administrative reasons.,f,,,,t,t,f,,,,,,Beginning 9 months and ending 36 months following article publication.,"Access will be considered to researchers who provide a methodologically sound proposal. Analysis must achieve the aims outlined in the approved proposal. Proposals should be directed to edegoma@exicuretx.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 36 months following article publication.",,YES,"Individual participant data that underlie the results reported in the article, after de-identification (text, tables, figures, and appendices) will be shared to researchers who provide a methodologically sound proposal and sign a data access agreement.",2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,INDUSTRY,,,,,,,2022,0.0
NCT05144334,,2021-11-09,,,2023-09-14,2021-11-22,2021-12-03,ACTUAL,,,,,,,2023-09-14,2023-09-18,ACTUAL,2022-01-24,ACTUAL,2022-01-24,2023-09,2023-09-30,2023-09-12,ACTUAL,2023-09-12,2023-09-12,ACTUAL,2023-09-12,,INTERVENTIONAL,,,A Study of BTX-1188 in Subjects With Advanced Malignancies,"An Open Label, Escalating Multiple Dose Study to Evaluate the Safety, Toxicity, Pharmacokinetics, and Preliminary Activity of BTX-1188 in Subjects With Advanced Malignancies",TERMINATED,,PHASE1,8.0,ACTUAL,"Biotheryx, Inc.",,7.0,,Business decision,,,,,t,t,f,,,,,,,,,,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,INDUSTRY,,,,,,,2023,0.0
NCT03783702,,2018-12-19,2021-07-16,,2021-08-07,2018-12-19,2018-12-21,ACTUAL,2021-08-07,2021-09-01,ACTUAL,,,,2021-08-07,2021-09-01,ACTUAL,2019-04-04,ACTUAL,2019-04-04,2021-08,2021-08-31,2020-12-30,ACTUAL,2020-12-30,2020-07-01,ACTUAL,2020-07-01,,INTERVENTIONAL,,,Pain Control Following Sinus Surgery,"Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery",COMPLETED,,PHASE4,118.0,ACTUAL,Stanford University,"The low levels of narcotic consumption observed may have precluded achieving significance in pain score comparisons across groups, as the pre-hoc power analysis predicted higher levels of opioid use~Selection bias: 1) patient willingness to participate in an opioid-related study could serve as a source of bias 2) loss to follow up~Lack of blinding and placebo were additional limitations",2.0,,,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,OTHER,,,,,,,2020,1.0
NCT03355664,,2017-11-01,2021-10-14,,2022-03-17,2017-11-21,2017-11-28,ACTUAL,2022-03-17,2022-07-15,ACTUAL,,,,2022-03-17,2022-07-15,ACTUAL,2018-03-19,ACTUAL,2018-03-19,2022-03,2022-03-31,2020-03-04,ACTUAL,2020-03-04,2020-03-04,ACTUAL,2020-03-04,,INTERVENTIONAL,TACT-CV,,Study to Compare the Triple ACT AL+AQ With the ACT AL in Cambodia and Vietnam,"A Multi-centre, Open-label Randomised Trial to Assess the Efficacy, Safety and Tolerability of the Triple ACT Artemether-lumefantrine+Amodiaquine (AL+AQ) Compared to the ACT Artemether-lumefantrine (AL) in Uncomplicated Falciparum Malaria in Cambodia and Vietnam",COMPLETED,,PHASE3,310.0,ACTUAL,University of Oxford,,2.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,OTHER,,,,,,,2020,1.0
NCT04198818,,2019-12-11,2024-03-25,,2024-07-17,2019-12-11,2019-12-13,ACTUAL,2024-07-17,2024-07-19,ACTUAL,,,,2024-07-17,2024-07-19,ACTUAL,2020-01-07,ACTUAL,2020-01-07,2024-07,2024-07-31,2023-03-31,ACTUAL,2023-03-31,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patient With Advanced Tumors","A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patients With Advanced Tumors",TERMINATED,,PHASE1/PHASE2,37.0,ACTUAL,"Haihe Biopharma Co., Ltd.",,1.0,,Sponsor business decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,INDUSTRY,,,,,,,2023,0.0
NCT04941443,,2021-06-15,2022-12-28,,2022-12-28,2021-06-24,2021-06-28,ACTUAL,2022-12-28,2023-01-23,ACTUAL,,,,2022-12-28,2023-01-23,ACTUAL,2021-10-04,ACTUAL,2021-10-04,2022-12,2022-12-31,2022-03-01,ACTUAL,2022-03-01,2022-03-01,ACTUAL,2022-03-01,,INTERVENTIONAL,,,Methadone and Medication Abortion,Methadone for Pain Relief in First Trimester Medication Abortion,TERMINATED,,PHASE4,4.0,ACTUAL,Boston Medical Center,"The study was halted prematurely as it was very difficult to recruit participants. Of the 4 consented participants, none provided the information needed for any of the outcome measures, so no results are available.",1.0,,Inability to recruit more participants.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,OTHER,,,,,,,2022,0.0
NCT03737240,,2018-11-08,2023-07-08,,2023-08-15,2018-11-08,2018-11-09,ACTUAL,2023-08-15,2023-09-08,ACTUAL,,,,2023-08-15,2023-09-08,ACTUAL,2019-01-15,ACTUAL,2019-01-15,2023-08,2023-08-31,2022-07-08,ACTUAL,2022-07-08,2022-07-08,ACTUAL,2022-07-08,,INTERVENTIONAL,,,IDegLira HIGH Trial,A Randomized Controlled Trial Comparing the Safety and Efficacy of IDegLira Versus Basal Bolus in Patients With Poorly Controlled Type 2 Diabetes,COMPLETED,,PHASE3,145.0,ACTUAL,Emory University,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 17:51:08.617379,2024-10-15 17:51:08.617379,OTHER,,,,,,,2022,0.0
NCT04213573,,2019-12-18,,,2020-03-24,2019-12-27,2019-12-30,ACTUAL,,,,,,,2020-03-24,2020-03-26,ACTUAL,2020-01-21,ACTUAL,2020-01-21,2020-03,2020-03-31,2020-12-20,ESTIMATED,2020-12-20,2020-10-20,ESTIMATED,2020-10-20,,INTERVENTIONAL,,,Efficacy of Silver Diamine Fluoride and Its Parental Perception,Parental Perception of Silver Diamine Fluoride Staining and Its Efficacy on Caries Arrestment in Comparison to Sodium Fluoride With Casein Phosphopeptide-amorphous Calcium Phosphate,SUSPENDED,,PHASE2/PHASE3,60.0,ESTIMATED,University of Baghdad,,2.0,,because of corona virus epidemic,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,OTHER,,,,,,,2020,0.0
NCT03652623,,2018-06-25,,,2024-03-29,2018-08-28,2018-08-29,ACTUAL,,,,,,,2024-03-29,2024-04-01,ACTUAL,2018-07-23,ACTUAL,2018-07-23,2024-03,2024-03-31,2023-11-30,ACTUAL,2023-11-30,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,,,"Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - PK Study","Transgender Youth and PrEP: PK, Safety, Uptake & Adherence",COMPLETED,,PHASE1/PHASE2,49.0,ACTUAL,Hektoen Institute for Medical Research,,1.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,OTHER,,,,,,,2023,1.0
NCT04707352,,2021-01-11,,,2023-07-11,2021-01-11,2021-01-13,ACTUAL,,,,,,,2023-07-11,2023-07-12,ACTUAL,2021-02-08,ACTUAL,2021-02-08,2023-02,2023-02-28,2023-03-26,ACTUAL,2023-03-26,2023-03-26,ACTUAL,2023-03-26,,INTERVENTIONAL,MODA,,Impact on Atrial Remodeling of Dapaglifozin in Patients With Heart Failure .,Impact on Atrial Remodeling of Dapaglifozin in Patients With Heart Failure .,COMPLETED,,PHASE3,162.0,ACTUAL,Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia,,1.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,OTHER,,,,,,,2023,1.0
NCT02255656,,2014-09-30,2021-06-30,,2022-03-21,2014-09-30,2014-10-02,ESTIMATED,2021-06-30,2021-07-23,ACTUAL,,,,2022-03-21,2022-03-28,ACTUAL,2015-01-07,ACTUAL,2015-01-07,2022-03,2022-03-31,2020-07-15,ACTUAL,2020-07-15,2020-07-15,ACTUAL,2020-07-15,,INTERVENTIONAL,TOPAZ,Analysis was performed on all enrolled participants.,Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409,A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409),COMPLETED,,PHASE4,1062.0,ACTUAL,Sanofi,,1.0,,,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,INDUSTRY,,,,,,,2020,1.0
NCT05012436,,2021-07-27,,,2022-06-28,2021-08-12,2021-08-19,ACTUAL,,,,,,,2022-06-28,2022-06-30,ACTUAL,2021-07-24,ACTUAL,2021-07-24,2022-06,2022-06-30,2022-05-10,ACTUAL,2022-05-10,2022-05-10,ACTUAL,2022-05-10,,INTERVENTIONAL,,,A Study to Evaluate the Pharmacokinetics and Safety of YHD1119 in Subjects With Renal Impairment and Healthy Subjects,A Study to Evaluate the Pharmacokinetics and Safety Following a Single Oral Dose of YHD1119 in Subjects With Renal Impairment and Healthy Subjects,COMPLETED,,PHASE1,16.0,ACTUAL,Yuhan Corporation,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,INDUSTRY,,,,,,,2022,1.0
NCT01977638,,2013-11-05,,,2022-10-17,2013-11-05,2013-11-07,ESTIMATED,,,,,,,2022-10-17,2022-10-18,ACTUAL,2014-02-14,ACTUAL,2014-02-14,2021-10,2021-10-31,2022-10-14,ACTUAL,2022-10-14,2019-10-08,ACTUAL,2019-10-08,,INTERVENTIONAL,,,Phase 1 Trial of CXD101 in Patients With Advanced Cancer,"Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CXD101 Given Orally (Twice Daily Dosing for 5 Consecutive Days in a 21-day Period) in Patients With Advanced Malignancies Expressing the Biomarker HR23B",COMPLETED,,PHASE1,51.0,ACTUAL,Oxford University Hospitals NHS Trust,,1.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-15 17:51:08.617379,2024-10-15 17:51:08.617379,OTHER,,,,,,,2022,1.0
NCT04571515,,2020-09-21,2022-04-07,,2022-07-12,2020-09-25,2020-10-01,ACTUAL,2022-07-12,2022-08-08,ACTUAL,,,,2022-07-12,2022-08-08,ACTUAL,2020-09-29,ACTUAL,2020-09-29,2022-07,2022-07-31,2020-12-22,ACTUAL,2020-12-22,2020-12-15,ACTUAL,2020-12-15,,INTERVENTIONAL,,Safety Analysis Set,Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain,"A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain",COMPLETED,,PHASE2,114.0,ACTUAL,Viatris Inc.,,5.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,INDUSTRY,,,,,,,2020,1.0
NCT04483687,,2020-07-20,,,2021-01-07,2020-07-20,2020-07-23,ACTUAL,,,,,,,2021-01-07,2021-01-11,ACTUAL,2020-12,ESTIMATED,2020-12-31,2021-01,2021-01-31,2024-09,ESTIMATED,2024-09-30,2023-01,ESTIMATED,2023-01-31,,INTERVENTIONAL,SEALION1-IR,,Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug Therapy,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug Therapy",WITHDRAWN,,PHASE3,0.0,ACTUAL,Gilead Sciences,,5.0,,Development program terminated,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,INDUSTRY,,,,,,,2024,0.0
NCT04641975,,2020-11-19,2023-12-07,,2024-08-21,2020-11-19,2020-11-24,ACTUAL,2023-12-07,2023-12-28,ACTUAL,,,,2024-08-21,2024-08-23,ACTUAL,2021-03-15,ACTUAL,2021-03-15,2024-08,2024-08-31,2023-07-24,ACTUAL,2023-07-24,2023-07-07,ACTUAL,2023-07-07,,INTERVENTIONAL,Dolphin,Safety Analysis Set (SAF) included all participants who received at least one dose of study drug.,A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB),"A Phase 3, Double-blind, Randomized, Multicenter, Parallel Group, Placebo-controlled Sequential Dose Titration Study to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Pediatric Subjects From 5 to < 18 Years of Age With Overactive Bladder",TERMINATED,,PHASE3,26.0,ACTUAL,Astellas Pharma Inc,,4.0,,Termination due to operational futility,f,,,,t,t,f,,,t,,,,,,NO,Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.,2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,INDUSTRY,,,,,,,2023,0.0
NCT02544880,,2015-09-04,,,2021-06-10,2015-09-04,2015-09-09,ESTIMATED,,,,,,,2021-06-10,2021-06-15,ACTUAL,2016-04-25,ACTUAL,2016-04-25,2021-06,2021-06-30,2021-06-08,ACTUAL,2021-06-08,2019-06-02,ACTUAL,2019-06-02,,INTERVENTIONAL,,,PDE5 Inhibition Via Tadalafil to Enhance Anti-Tumor Mucin 1 (MUC1) Vaccine Efficacy in Patients With HNSCC,"PDE5 Inhibition Via Tadalafil (Cialis®) to Enhance Anti-Tumor MUC1 Vaccine Efficacy in Patients With Resectable, and Recurrent or Second Primary Head and Neck Squamous Cell Carcinoma (HNSCC): A Phase I/II Clinical Trial",COMPLETED,,PHASE1,16.0,ACTUAL,University of Miami,,5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,OTHER,,,,,,,2021,1.0
NCT04008043,,2019-07-02,,,2019-11-11,2019-07-02,2019-07-05,ACTUAL,,,,,,,2019-11-11,2019-11-13,ACTUAL,2020-02,ESTIMATED,2020-02-29,2019-11,2019-11-30,2021-05,ESTIMATED,2021-05-31,2021-05,ESTIMATED,2021-05-31,,INTERVENTIONAL,,,Pilot Study: Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain,The Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain After Periodontal Surgery Among Patients at the Henry M. Goldman School of Dental Medicine Pilot Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,Boston University,,2.0,,Inadequate resources to start the study at this site.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 07:29:50.700509,2024-10-15 07:29:50.700509,OTHER,,,,,,,2021,0.0
NCT02721979,,2016-03-11,2021-02-04,,2023-02-06,2016-03-22,2016-03-29,ESTIMATED,2021-03-26,2021-03-29,ACTUAL,,,,2023-02-06,2023-02-09,ACTUAL,2017-11-02,ACTUAL,2017-11-02,2023-02,2023-02-28,2021-11-30,ACTUAL,2021-11-30,2020-02-12,ACTUAL,2020-02-12,,INTERVENTIONAL,,"There are 24 participants who signed the consent form, and only 23 progressed into the treatment phase. One patient was a screen fail.",Apalutamide in Treating Patients With Prostate Cancer Who Are in Active Surveillance,A Phase 2 Study of Apalutamide in Active Surveillance Patients,TERMINATED,,PHASE2,24.0,ACTUAL,University of Washington,"We acknowledge that the small sample size of this study is one of its primary limitations, which was further challenged by its premature termination.",1.0,,Terminated due to slow accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:35:53.059413,2024-10-15 07:35:53.059413,OTHER,,,,,,,2021,0.0
NCT05829187,,2023-01-09,,,2023-05-13,2023-04-12,2023-04-25,ACTUAL,,,,,,,2023-05-13,2023-05-16,ACTUAL,2022-11-01,ACTUAL,2022-11-01,2023-05,2023-05-31,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,MCHUPF,,Momordica Charantia and Dihydroartemisinin-piperaquined-primaquine for Uncomplicated Plasmodium Falciparum Malaria Patients in Southwest Sumba Regency,"Effectiveness of Momordica Charantia Extract Compared to the Standard Antimalarial Drug Combination Dihydroartemisinin Piperaquine-primaquine in Patients With Uncomplicated Falciparum Malaria, in Sumba Barat Daya District of Indonesia",COMPLETED,,PHASE2,36.0,ACTUAL,Pancasila University,,2.0,,,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 07:35:53.059413,2024-10-15 07:35:53.059413,OTHER,,,,,,,2022,1.0
NCT04025632,,2019-07-17,2022-03-03,,2022-07-26,2019-07-17,2019-07-19,ACTUAL,2022-04-21,2022-05-16,ACTUAL,,,,2022-07-26,2022-07-27,ACTUAL,2019-11-07,ACTUAL,2019-11-07,2022-07,2022-07-31,2021-06-14,ACTUAL,2021-06-14,2021-03-04,ACTUAL,2021-03-04,,INTERVENTIONAL,,Intent-to-Treat (ITT) Population included all randomized participants.,Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy,"A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy",TERMINATED,,PHASE2,27.0,ACTUAL,UCB Pharma,The study was terminated based on the primary efficacy endpoint analysis after the first data lock.,2.0,,The study was terminated based on the primary efficacy endpoint analysis after the first data lock.,f,,,,,t,f,,,,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",http://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,INDUSTRY,,,,,,,2021,0.0
NCT02581943,,2015-10-13,2023-11-21,,2024-01-03,2015-10-19,2015-10-21,ESTIMATED,2024-01-03,2024-01-05,ACTUAL,,,,2024-01-03,2024-01-05,ACTUAL,2016-06-17,ACTUAL,2016-06-17,2023-12,2023-12-31,2022-12-28,ACTUAL,2022-12-28,2022-11-19,ACTUAL,2022-11-19,,INTERVENTIONAL,,,Effect of Pembrolizumab With or Without Carboplatin and Paclitaxel on Immune Response in Patients With Recurrent or Stage IIIB-IV Non-small Cell Lung Cancer,Immune Response in Patients With Recurrent or Metastatic Non-small Cell Lung Cancer and Performance Status of 2 Treated With a Combination of Pembrolizumab and Low Dose Weekly Carboplatin/Paclitaxel,COMPLETED,,PHASE2,43.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 07:35:53.059413,2024-10-15 07:35:53.059413,OTHER,,,,,,,2022,1.0
NCT05567523,,2022-09-29,,,2022-10-09,2022-10-01,2022-10-05,ACTUAL,,,,,,,2022-10-09,2022-10-13,ACTUAL,2019-06-01,ACTUAL,2019-06-01,2022-10,2022-10-31,2022-03-30,ACTUAL,2022-03-30,2022-02-28,ACTUAL,2022-02-28,,INTERVENTIONAL,,,Safety Study of Dexmedetomidine in Elderly Under General Anesthesia,Effects of Dexmedetomidine at Different Doses on Hemodynamics and Recovery Quality in Elderly Patients Undergoing Hip Replacement Surgery Under General Anesthesia,COMPLETED,,PHASE4,200.0,ACTUAL,Zhenjiang First People's Hospital,,2.0,,,f,,,,,f,f,,,,,,Data are available after publication and up to one year after publication.,Send an email to dolinet@163.com,,YES,"all collected IPD, all IPD that underlie results in a publication",2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2022,1.0
NCT04561219,,2020-09-22,,,2021-07-15,2020-09-22,2020-09-23,ACTUAL,,,,,,,2021-07-15,2021-07-22,ACTUAL,2020-04-19,ACTUAL,2020-04-19,2021-07,2021-07-31,2020-10-02,ACTUAL,2020-10-02,2020-10-02,ACTUAL,2020-10-02,,INTERVENTIONAL,,,Nitazoxanide Therapy for Patients With COVID-19 Pneumonia,"Nitazoxanide for Moderate to Severe COVID-19 Pneumonia: a Multicenter, Randomized, Placebo-controlled, Double-Blind Clinical Trial",COMPLETED,,PHASE2,500.0,ACTUAL,Universidade Federal do Rio de Janeiro,,2.0,,,f,,,,t,f,f,,,,,,Available as soon as the editorial board of the journal accepting the manuscript requires.,Editorial board of the Journal accepting the manuscript.,,YES,"The investigators plan on sharing all IPD that underlie results in a publication for editorial board, with cautious of not sharing confidential data.",2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,OTHER,,,,,,,2020,0.0
NCT05152563,,2021-11-29,,,2023-03-02,2021-12-09,2021-12-10,ACTUAL,,,,,,,2023-03-02,2023-03-03,ACTUAL,2021-12,ESTIMATED,2021-12-31,2023-03,2023-03-31,2022-01-20,ACTUAL,2022-01-20,2022-01-20,ACTUAL,2022-01-20,,INTERVENTIONAL,ENIGMA-SC,,A Study to Assess Subcutaneous AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis,"A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of Subcutaneous AK002 in Subjects With Moderate to Severe Eosinophilic Gastritis and/or Eosinophilic Duodenitis",WITHDRAWN,,PHASE3,0.0,ACTUAL,Allakos Inc.,,4.0,,Company decision,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:35:53.059413,2024-10-15 07:35:53.059413,INDUSTRY,,,,,,,2022,0.0
NCT02341625,,2015-01-14,2022-04-11,,2022-07-21,2015-01-14,2015-01-19,ESTIMATED,2022-07-21,2022-08-18,ACTUAL,,,,2022-07-21,2022-08-18,ACTUAL,2015-06-19,ACTUAL,2015-06-19,2022-07,2022-07-31,2020-05-07,ACTUAL,2020-05-07,2019-02-25,ACTUAL,2019-02-25,,INTERVENTIONAL,,,A Study of BMS-986148 in Patients With Select Advanced Solid Tumors,"A Phase I/IIa Study of BMS-986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects With Select Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,126.0,ACTUAL,Bristol-Myers Squibb,,4.0,,Study terminated for business reasons not related to safety.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,INDUSTRY,,,,,,,2020,0.0
NCT04181255,,2019-11-26,,,2023-09-07,2019-11-26,2019-11-29,ACTUAL,,,,,,,2023-09-07,2023-09-13,ACTUAL,2020-02-25,ACTUAL,2020-02-25,2023-09,2023-09-30,2020-06-12,ACTUAL,2020-06-12,2020-06-12,ACTUAL,2020-06-12,,INTERVENTIONAL,,,Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy,The Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy Following Deep Hypothermic Circulatory Arrest During Cardiac Surgery,TERMINATED,,PHASE1,2.0,ACTUAL,University of Michigan,,2.0,,Investigator Retirement,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,OTHER,,,,,,,2020,0.0
NCT04149275,,2019-10-22,,,2021-02-18,2019-10-30,2019-11-04,ACTUAL,,,,,,,2021-02-18,2021-02-21,ACTUAL,2021-02,ESTIMATED,2021-02-28,2021-02,2021-02-28,2021-02,ESTIMATED,2021-02-28,2021-02,ESTIMATED,2021-02-28,,INTERVENTIONAL,,,Cabozantinib Plus Nivolumab and Ipilimumab in Women With Recurrent Gynecologic Carcinosarcoma,A Phase II Single Arm Study of Cabozantinib Plus Nivolumab and Ipilimumab in Women With Recurrent Gynecologic Carcinosarcoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Alabama at Birmingham,,1.0,,Funding withdrawn by sponsor,f,,,,t,t,f,,,,,,,,,NO,To Be Determined,2024-10-15 07:35:53.059413,2024-10-15 07:35:53.059413,OTHER,,,,,,,2021,0.0
NCT01378273,,2011-06-20,2020-07-02,,2020-08-14,2011-06-21,2011-06-22,ESTIMATED,2020-08-06,2020-08-17,ACTUAL,,,,2020-08-14,2020-08-26,ACTUAL,2013-12,,2013-12-31,2020-08,2020-08-31,2020-02-28,ACTUAL,2020-02-28,2019-02-28,ACTUAL,2019-02-28,,INTERVENTIONAL,PENUT,,Preterm Erythropoietin Neuroprotection Trial (PENUT Trial),Preterm Erythropoietin Neuroprotection Trial (PENUT Trial),COMPLETED,,PHASE3,941.0,ACTUAL,University of Washington,,2.0,,,f,,,,t,,,,,,,,December 2020,The data will be made available upon publication of all PENUT Trial related manuscripts to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.,https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Clinical-Research/Archived-Clinical-Research-Datasets,YES,"De-identified individual participant data will be made available through the NINDS Data Archive: https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Clinical-Research/Archived-Clinical-Research-Datasets. The data will be de-identified and a limited access data set will be available after December 2020 through a request form on that page. Data dictionaries, in addition to study protocol, the statistical analysis plan, and the informed consent form will be included. The data will be made available upon publication of all PENUT Trial related manuscripts to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.",2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,OTHER,,,,,,,2020,1.0
NCT05996445,,2023-06-23,,,2024-08-21,2023-08-10,2023-08-18,ACTUAL,,,,,,,2024-08-21,2024-08-23,ACTUAL,2023-07-28,ACTUAL,2023-07-28,2024-08,2024-08-31,2024-05-21,ACTUAL,2024-05-21,2024-05-21,ACTUAL,2024-05-21,,INTERVENTIONAL,,,A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors,"A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®662 in Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors",TERMINATED,,PHASE1,7.0,ACTUAL,"Xencor, Inc.",,2.0,,The Sponsor made a business decision to end the study.,f,,,,t,t,f,,,,,,,,,,,2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,INDUSTRY,,,,,,,2024,0.0
NCT04563559,,2020-09-21,,,2021-11-16,2020-09-21,2020-09-24,ACTUAL,,,,,,,2021-11-16,2021-11-17,ACTUAL,2020-11,ESTIMATED,2020-11-30,2021-11,2021-11-30,2021-11,ESTIMATED,2021-11-30,2021-11,ESTIMATED,2021-11-30,,INTERVENTIONAL,,,PREFERENTIAL Study,"Patient PReference, Efficacy, and SaFety of an Intracanalicular DExamenthasone InseRt comparEd to Topical PrednisoloNe in PatienTs UndergoIng SequentiAl PhacoemuLsification With Intraocular Lens Surgery OR Combined Phacoemulsification With IOL and a Minimally Invasive Glaucoma Surgery (MIGS)",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Duke University,,1.0,,PI decided not to open study,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,OTHER,,,,,,,2021,0.0
NCT02620761,,2015-10-27,2022-03-03,,2022-08-22,2015-11-30,2015-12-03,ESTIMATED,2022-08-22,2022-09-16,ACTUAL,,,,2022-08-22,2022-09-16,ACTUAL,2019-02-06,ACTUAL,2019-02-06,2022-08,2022-08-31,2020-01-31,ACTUAL,2020-01-31,2020-01-31,ACTUAL,2020-01-31,,INTERVENTIONAL,Fenaki,No analysis performed as only a single patient was enrolled,Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants,Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants,TERMINATED,,PHASE2/PHASE3,1.0,ACTUAL,Medical College of Wisconsin,,2.0,,Inability to recruit patients,f,,,,t,t,f,,,,,,,,,,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,OTHER,,,,,,,2020,0.0
NCT05123599,,2021-11-16,,,2024-07-17,2021-11-16,2021-11-17,ACTUAL,,,,,,,2024-07-17,2024-07-18,ACTUAL,2021-12-06,ACTUAL,2021-12-06,2024-07,2024-07-31,2024-06-26,ACTUAL,2024-06-26,2023-07-31,ACTUAL,2023-07-31,,INTERVENTIONAL,OSPREY,,"A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection","A Phase 1b, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Treatment With JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, HBeAg-negative Participants With Chronic Hepatitis B Virus Infection",COMPLETED,,PHASE1,24.0,ACTUAL,"Janssen Research & Development, LLC",,1.0,,,f,,,,f,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 07:35:53.059413,2024-10-15 07:35:53.059413,INDUSTRY,,,,,,,2024,1.0
NCT04297917,,2020-02-28,,,2022-07-22,2020-03-03,2020-03-06,ACTUAL,,,,,,,2022-07-22,2022-07-25,ACTUAL,2019-02-10,ACTUAL,2019-02-10,2022-03,2022-03-31,2022-05-26,ACTUAL,2022-05-26,2022-05-26,ACTUAL,2022-05-26,,INTERVENTIONAL,,,First in Human Study of ChAdOx1-HBV,"A Phase 1 Monotherapy Study to Evaluate the Safety, Tolerability & Immunogenicity of Vaccination With Candidate Chimpanzee Adenovirus-vectored HepB Virus Vaccine ChAdOx1 HBV in Healthy Participants & Participants With Chronic HepB Infection",COMPLETED,,PHASE1,47.0,ACTUAL,Barinthus Biotherapeutics,,6.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,INDUSTRY,,,,,,,2022,1.0
NCT02258815,,2013-08-07,,,2023-12-01,2014-10-02,2014-10-07,ESTIMATED,,,,,,,2023-12-01,2023-12-08,ACTUAL,2010-08,ACTUAL,2010-08-31,2023-12,2023-12-31,2022-12,ACTUAL,2022-12-31,2018-11,ACTUAL,2018-11-30,,INTERVENTIONAL,,,CH14.18 1021 Antibody and IL2 After Haplo SCT in Children With Relapsed Neuroblastoma,Phase II Feasability Study Using ch14.18/CHO Antibody and Subcutaneous Interleukin 2 After Haploidentical Stem Cell Transplantation in Children With Relapsed Neuroblastoma,COMPLETED,,PHASE2,35.0,ESTIMATED,University Children's Hospital Tuebingen,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,OTHER,,,,,,,2022,1.0
NCT04410874,,2020-05-27,,,2024-03-05,2020-05-27,2020-06-01,ACTUAL,,,,,,,2024-03-05,2024-03-07,ACTUAL,2020-11-16,ACTUAL,2020-11-16,2024-03,2024-03-31,2023-05-23,ACTUAL,2023-05-23,2023-05-23,ACTUAL,2023-05-23,,INTERVENTIONAL,MUSIC-01,,Imvamune Vaccine for the Treatment of Non-melanoma Skin Cancer,"MVA-BN Imvamune Smallpox Vaccine Virus for Treatment of Basal Cell Carcinoma, Squamous Cell Carcinomas",TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,McGill University Health Centre/Research Institute of the McGill University Health Centre,,1.0,,Inability to recruit patients/lack of funding,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2023,0.0
NCT03773302,,2018-12-10,2023-12-20,,2024-04-15,2018-12-10,2018-12-12,ACTUAL,2024-04-15,2024-05-08,ACTUAL,,,,2024-04-15,2024-05-08,ACTUAL,2019-12-27,ACTUAL,2019-12-27,2024-04,2024-04-30,2023-03-02,ACTUAL,2023-03-02,2023-03-02,ACTUAL,2023-03-02,,INTERVENTIONAL,,,Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations,"A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial",TERMINATED,,PHASE3,48.0,ACTUAL,"QED Therapeutics, Inc.",,2.0,,The sponsor has decided to close the study due to the discontinuation of infigratinib development in oncology within the sponsor's territory. The discontinuation of the study was not due to safety issues.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,INDUSTRY,,,,,,,2023,0.0
NCT04198363,,2019-12-12,2022-10-26,,2022-10-26,2019-12-12,2019-12-13,ACTUAL,2022-10-26,2023-09-07,ACTUAL,,,,2022-10-26,2023-09-07,ACTUAL,2020-04-30,ACTUAL,2020-04-30,2022-10,2022-10-31,2021-11-25,ACTUAL,2021-11-25,2021-11-01,ACTUAL,2021-11-01,,INTERVENTIONAL,,Full analysis set (FAS) included all randomized participants who received at least 1 dose of the study drug.,A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection,"A Randomized Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral TAK-438 20 mg Compared to Esomeprazole 20 mg Twice Daily in Subjects With Helicobacter Pylori Infection",COMPLETED,,PHASE3,510.0,ACTUAL,Takeda,,2.0,,,f,,,,f,f,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,INDUSTRY,,,,,,,2021,1.0
NCT04616027,,2020-10-29,2023-01-31,,2023-12-01,2020-10-29,2020-11-04,ACTUAL,2023-12-01,2024-05-10,ACTUAL,,,,2023-12-01,2024-05-10,ACTUAL,2021-01-13,ACTUAL,2021-01-13,2023-12,2023-12-31,2022-02-18,ACTUAL,2022-02-18,2022-02-18,ACTUAL,2022-02-18,,INTERVENTIONAL,,All enrolled participants who received at least one dose of study intervention.,STUDY OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT AND PARTICIPANTS WITHOUT RENAL IMPAIRMENT,"A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO EVALUATE THE PHARMACOKINETICS OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT RENAL IMPAIRMENT",COMPLETED,,PHASE1,42.0,ACTUAL,Pfizer,,5.0,,,,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 07:35:53.059413,2024-10-15 07:35:53.059413,INDUSTRY,,,,,,,2022,1.0
NCT05984784,,2023-07-25,,,2024-05-15,2023-08-02,2023-08-09,ACTUAL,,,,,,,2024-05-15,2024-05-16,ACTUAL,2023-08-09,ACTUAL,2023-08-09,2024-05,2024-05-31,2024-04-26,ACTUAL,2024-04-26,2024-04-26,ACTUAL,2024-04-26,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD)","A Phase1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis",TERMINATED,,PHASE1/PHASE2,13.0,ACTUAL,Inmagene LLC,,3.0,,Terminated because the sponsor believes that results from Cohort 1 will provide reliable information for further development decision. No safety concerns were noted.,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,INDUSTRY,,,,,,,2024,0.0
NCT04745663,,2021-02-05,,,2021-09-06,2021-02-05,2021-02-09,ACTUAL,,,,,,,2021-09-06,2021-09-14,ACTUAL,2021-02-08,ACTUAL,2021-02-08,2021-09,2021-09-30,2021-04-30,ACTUAL,2021-04-30,2021-04-30,ACTUAL,2021-04-30,,INTERVENTIONAL,,,Optimizing Preoperative Disinfection of Eyes,Optimizing Preoperative Disinfection of Eyes,TERMINATED,,PHASE4,150.0,ACTUAL,Norwegian University of Science and Technology,,2.0,,Not the expected 2/3 but only 1/3 of conjunctiva samples got bacterial growth. Lack of resources to keep the study going with more participants and over a considerably longer time than anticipated.,f,,,,f,f,f,,,,,,,,,,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,OTHER,,,,,,,2021,0.0
NCT03122301,,2017-04-18,2022-04-14,,2022-07-13,2017-04-19,2017-04-20,ACTUAL,2022-05-10,2022-06-03,ACTUAL,,,,2022-07-13,2022-08-09,ACTUAL,2017-06-01,ACTUAL,2017-06-01,2022-07,2022-07-31,2020-07-01,ACTUAL,2020-07-01,2020-07-01,ACTUAL,2020-07-01,,INTERVENTIONAL,,,Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer,Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer: A Pilot Randomized Sham-Controlled Trial,TERMINATED,,PHASE2,2.0,ACTUAL,Northwestern University,This study was terminated due to low enrollment,2.0,,Study stopped due to inadequate enrollment.,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 07:35:53.059413,2024-10-15 07:35:53.059413,OTHER,,,,,,,2020,0.0
NCT02856594,,2016-07-29,2023-02-21,,2023-02-21,2016-08-04,2016-08-05,ESTIMATED,2023-02-21,2023-03-20,ACTUAL,,,,2023-02-21,2023-03-20,ACTUAL,2017-03-06,ACTUAL,2017-03-06,2023-02,2023-02-28,2022-02-16,ACTUAL,2022-02-16,2022-02-11,ACTUAL,2022-02-11,,INTERVENTIONAL,MINDDS,,Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep,Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS): A Randomized Placebo-controlled Trial,COMPLETED,,PHASE2/PHASE3,469.0,ACTUAL,Massachusetts General Hospital,,2.0,,,f,,,,t,t,f,,,,,,Immediately,"De-identified data and a data dictionary will be made available upon reasonable request to researchers who provide a methodologically sound proposal and whose use of the data has been approved the study authors. Data will be made available immediately following publication, with no anticipated end date, to achieve the aims specified in the approved proposal. Proposals should be directed to oluwaseun.akeju@mgh.harvard.edu.",,YES,,2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,OTHER,,,,,,,2022,1.0
NCT03347708,,2017-11-01,,,2023-01-23,2017-11-15,2017-11-20,ACTUAL,,,,,,,2023-01-23,2023-01-25,ACTUAL,2018-02-26,ACTUAL,2018-02-26,2022-11,2022-11-30,2022-11-10,ACTUAL,2022-11-10,2022-02-01,ACTUAL,2022-02-01,,INTERVENTIONAL,,,"Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration","A Prospective, Randomized, Double-Blinded, Vehicle- and Placebo-Controlled, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of IDCT in Subjects With Single-Level, Symptomatic Lumbar Intervertebral Disc Degeneration",COMPLETED,,PHASE1,60.0,ACTUAL,"DiscGenics, Inc.",,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:35:53.059413,2024-10-15 07:35:53.059413,INDUSTRY,,,,,,,2022,1.0
NCT01600963,,2012-04-24,,,2015-11-30,2012-05-16,2012-05-17,ESTIMATED,,,,,,,2015-11-30,2015-12-02,ESTIMATED,2014-03,,2014-03-31,2015-11,2015-11-30,2022-11,ESTIMATED,2022-11-30,2016-07,ESTIMATED,2016-07-31,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis,"A Phase III Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Efficacy and Safety of TMC207 in Subjects With Sputum Smear-positive Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB)",WITHDRAWN,,PHASE3,0.0,ACTUAL,Janssen Infectious Diseases BVBA,,2.0,,PhIII program revised; TMC207-C210 cancelled,f,,,,t,,,,,,,,,,,,,2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,INDUSTRY,,,,,,,2022,0.0
NCT03701321,,2018-10-08,,,2023-09-22,2018-10-08,2018-10-10,ACTUAL,,,,,,,2023-09-22,2023-09-26,ACTUAL,2019-01-25,ESTIMATED,2019-01-25,2023-09,2023-09-30,2020-05-28,ESTIMATED,2020-05-28,2020-05-28,ESTIMATED,2020-05-28,,INTERVENTIONAL,,,"Daratumumab, Bortezomib, and Dexamethasone With or Without Venetoclax in Treating Patients With Relapsed or Refractory Multiple Myeloma","Phase 1/2 Study of Daratumumab, Bortezomib, Dexamethasone With or Without Venetoclax in Relapsed/Refractory Multiple Myeloma With Assessment for t(11;14) Status",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,National Cancer Institute (NCI),,3.0,,Drug supply issues,f,,,,t,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page",2024-10-15 07:35:53.059413,2024-10-15 07:35:53.059413,NIH,,,,,,,2020,0.0
NCT03823391,,2019-01-29,2021-06-29,2021-03-23,2021-06-29,2019-01-29,2019-01-30,ACTUAL,2021-06-29,2021-07-19,ACTUAL,2021-03-23,2021-03-26,ACTUAL,2021-06-29,2021-07-19,ACTUAL,2019-03-27,ACTUAL,2019-03-27,2021-06,2021-06-30,2020-08-26,ACTUAL,2020-08-26,2020-04-08,ACTUAL,2020-04-08,,INTERVENTIONAL,,The Full Analysis Set (FAS) includes all randomized participants who received at least 1 dose of the study drugs.,"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)","A Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects With Moderate to Severe Rheumatoid Arthritis",COMPLETED,,PHASE2,48.0,ACTUAL,AbbVie,,2.0,,,f,,,,t,t,f,,,t,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,INDUSTRY,,,,,,,2020,1.0
NCT02547922,,2015-08-31,2021-09-07,2020-09-14,2021-10-28,2015-09-10,2015-09-14,ESTIMATED,2021-10-28,2021-11-24,ACTUAL,2020-09-14,2020-09-16,ACTUAL,2021-10-28,2021-11-24,ACTUAL,2015-11-04,ACTUAL,2015-11-04,2021-10,2021-10-31,2021-01-18,ACTUAL,2021-01-18,2019-11-26,ACTUAL,2019-11-26,,INTERVENTIONAL,TULIP-LN1,The full analysis set included all subjects who received at least one dose of study treatment and were analyzed according to randomized treatment.,Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis,"A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Proliferative Lupus Nephritis",COMPLETED,,PHASE2,147.0,ACTUAL,AstraZeneca,,3.0,,,f,,,,t,t,f,,,,,,AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.,"When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,INDUSTRY,,,,,,,2021,1.0
NCT04424641,,2020-05-14,2022-10-16,,2023-07-24,2020-06-05,2020-06-11,ACTUAL,2023-01-05,2023-02-01,ACTUAL,,,,2023-07-24,2023-07-25,ACTUAL,2020-07-15,ACTUAL,2020-07-15,2023-07,2023-07-31,2021-10-29,ACTUAL,2021-10-29,2021-10-29,ACTUAL,2021-10-29,,INTERVENTIONAL,,Full analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the assigned dose level cohort.,A Study on the Safety of GEN1044 (DuoBody®-CD3x5T4) in Patients With Malignant Solid Tumors,"First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1044 in Subjects With Malignant Solid Tumors",TERMINATED,,PHASE1/PHASE2,48.0,ACTUAL,Genmab,"Upon review and evaluation of the overall safety profile and safety signals of GEN1044 during the dose-escalation part, the Safety Committee decided to stop further enrollment and the Sponsor decided to stop the compound development. Hence, the expansion part of the trial was never initiated, and while a majority of the pharmacokinetic (PK) samples from the dose-escalation part were quantified, the PK parameters were not calculated due to termination of the trial.",1.0,,Study was terminated due to MTD was reached,f,,,,t,t,f,,,,,,,,,,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,INDUSTRY,,,,,,,2021,0.0
NCT02807467,,2016-05-09,,,2023-06-05,2016-06-20,2016-06-21,ESTIMATED,,,,,,,2023-06-05,2023-06-06,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2023-06,2023-06-30,2023-02-11,ACTUAL,2023-02-11,2022-03-03,ACTUAL,2022-03-03,,INTERVENTIONAL,,,Influence of Dexmedetomidine or Propofol on ICU Delirium,Comparison of Propofol and Dexmedetomidine to Treat Hyperactive and Mixed ICU Delirium - the Basel ProDex Randomized Trial,TERMINATED,,PHASE4,37.0,ACTUAL,"University Hospital, Basel, Switzerland",,2.0,,insufficient recruitment over a long period,f,,,,t,f,f,,,,,,,,,NO,anonymized data will be analyzed and published,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,OTHER,,,,,,,2023,0.0
NCT04354727,,2020-04-17,,,2022-07-08,2020-04-17,2020-04-21,ACTUAL,,,,,,,2022-07-08,2022-07-12,ACTUAL,2020-12-15,ESTIMATED,2020-12-15,2022-07,2022-07-31,2023-06-15,ESTIMATED,2023-06-15,2022-12-15,ESTIMATED,2022-12-15,,INTERVENTIONAL,,,A Study of APG-1252 in Patients With Myelofibrosis Who Progressed After Initial Therapy,Phase Ib/II Study of APG-1252 in Patients With Myelofibrosis Who Progressed After Initial Therapy,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Ascentage Pharma Group Inc.,,2.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 07:35:53.059413,2024-10-15 07:35:53.059413,INDUSTRY,,,,,,,2023,0.0
NCT03802747,,2019-01-08,,,2019-10-04,2019-01-10,2019-01-14,ACTUAL,,,,,,,2019-10-04,2019-10-08,ACTUAL,2019-08,ESTIMATED,2019-08-31,2019-10,2019-10-31,2024-12,ESTIMATED,2024-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Immunotherapy Combined With Y-90 and SBRT for Colorectal Liver Metastases,Phase I Study of Dual Immune Checkpoint Blockade (Anti-PD-L1 (Durvalumab) (MEDI4736) and Anti-CTLA4 (Tremelimumab) Plus Yttrium-90 (Y-90) Radioembolization & Stereotactic Body Radiation Therapy (SBRT) in Refractory Metastatic MSS (Microsatellite Stable) Colorectal Cancer With Liver Metastases,WITHDRAWN,,PHASE1,0.0,ACTUAL,"University of Colorado, Denver",,2.0,,PI left the institution,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:35:53.059413,2024-10-15 07:35:53.059413,OTHER,,,,,,,2024,0.0
NCT04833855,,2021-04-05,2024-04-08,2023-08-25,2024-04-08,2021-04-05,2021-04-06,ACTUAL,2024-04-08,2024-05-01,ACTUAL,,2023-09-01,ACTUAL,2024-04-08,2024-05-01,ACTUAL,2021-04-15,ACTUAL,2021-04-15,2024-03,2024-03-31,2023-04-13,ACTUAL,2023-04-13,2022-12-20,ACTUAL,2022-12-20,,INTERVENTIONAL,INCEPTION,,Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria,"A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging, Phase 2b Study to Evaluate Efficacy and Safety of Tezepelumab for the Treatment of Chronic Spontaneous Urticaria",COMPLETED,,PHASE2,183.0,ACTUAL,Amgen,,7.0,,,,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,INDUSTRY,,,,,,,2023,1.0
NCT03690154,,2018-09-21,,,2023-10-12,2018-09-27,2018-10-01,ACTUAL,,,,,,,2023-10-12,2023-10-13,ACTUAL,2018-07-23,ACTUAL,2018-07-23,2022-07,2022-07-31,2022-02-11,ACTUAL,2022-02-11,2022-02-11,ACTUAL,2022-02-11,,INTERVENTIONAL,,,A Phase 1 Study to Evaluate FN-1501 Monotherapy in Patients With Advanced Solid Tumors and R/R AML,"A Phase 1, Multi-center, Open-label, Single-arm, Dose-escalation, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of FN-1501 Monotherapy in Patients With Advanced Solid Tumors or Relapsed/Refractory Acute Myeloid Leukemia (AML)",TERMINATED,,PHASE1,67.0,ACTUAL,Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.,,1.0,,Despite demonstrated safety and tolerability the trial was terminated early due to program re-prioritization in light of the competitive landscape.,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,INDUSTRY,,,,,,,2022,0.0
NCT03193437,,2017-06-19,2022-10-25,,2023-02-10,2017-06-19,2017-06-20,ACTUAL,2023-02-10,2023-02-16,ACTUAL,,,,2023-02-10,2023-02-16,ACTUAL,2018-04-03,ACTUAL,2018-04-03,2022-04,2022-04-30,2022-01-31,ACTUAL,2022-01-31,2020-07-27,ACTUAL,2020-07-27,,INTERVENTIONAL,SELECT,,Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy,"A Phase 2, Open-label Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumor (TET) Progressing After Primary Chemotherapy (SELECT)",TERMINATED,,PHASE2,8.0,ACTUAL,Georgetown University,,1.0,,Slow Accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,OTHER,,,,,,,2022,0.0
NCT03207334,,2017-06-26,,,2018-10-18,2017-06-30,2017-07-02,ACTUAL,,,,,,,2018-10-18,2018-10-22,ACTUAL,2018-11,ESTIMATED,2018-11-30,2018-10,2018-10-31,2022-01,ESTIMATED,2022-01-31,2021-01,ESTIMATED,2021-01-31,,INTERVENTIONAL,,,iCare4: Genomic Signatures With Midostaurin in Acute Myeloid Leukemia (UF-HEM-004),"A Phase II, Open-Label Clinical Efficacy Study Defining Genomic Signatures That Correlate With Midostaurin Response in Relapsed or Refractory Acute Myeloid Leukemia (AML)",WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Florida,,1.0,,Insufficient funding,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 07:35:53.059413,2024-10-15 07:35:53.059413,OTHER,,,,,,,2022,0.0
NCT04345666,,2020-04-09,,,2022-02-28,2020-04-13,2020-04-14,ACTUAL,,,,,,,2022-02-28,2022-03-15,ACTUAL,2021-08,ESTIMATED,2021-08-31,2022-02,2022-02-28,2023-01,ESTIMATED,2023-01-31,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,,,Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair,"A Randomized, Blinded Controlled Trial to Determine if Testosterone Can Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,"Orthopedic Institute, Sioux Falls, SD",,2.0,,Unable to obtain funding to complete the study,f,,,,f,t,f,,,,,,,,,NO,At this point there is no plan to share individual participant data with researcher external to this study,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2023,0.0
NCT04290858,,2020-02-27,,,2020-03-22,2020-02-28,2020-03-02,ACTUAL,,,,,,,2020-03-22,2020-03-24,ACTUAL,2020-03-01,ESTIMATED,2020-03-01,2020-03,2020-03-31,2022-02-01,ESTIMATED,2022-02-01,2021-03-01,ESTIMATED,2021-03-01,,INTERVENTIONAL,NoCovid,,Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID19 Infection,Nitric Oxide Gas Inhalation Therapy in Spontaneous Breathing Patients With Mild/Moderate COVID19 Infection: a Randomized Clinical Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,Xijing Hospital,,2.0,,New coordinating center has been defined (Massachusetts General Hospital),f,,,,t,f,f,,,,,,,,,,,2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,OTHER,,,,,,,2022,0.0
NCT03798080,,2019-01-07,,,2022-07-14,2019-01-07,2019-01-09,ACTUAL,,,,,,,2022-07-14,2022-07-19,ACTUAL,2019-02-19,ACTUAL,2019-02-19,2022-04,2022-04-30,2020-12-01,ACTUAL,2020-12-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,Lixilan-L-CN,,Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin,"A Randomized, 30-week, Active-controlled, Open-label, 2 Treatment-arm, Parallel Group, Multicenter Study Comparing Efficacy and Safety of iGlarLixi to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled on Basal Insulin With or Without Oral Antidiabetic Drug(s)",COMPLETED,,PHASE3,426.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,f,f,,,f,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,INDUSTRY,,,,,,,2020,1.0
NCT04217057,,2019-12-30,2024-01-31,,2024-01-31,2020-01-02,2020-01-03,ACTUAL,2024-01-31,2024-02-28,ACTUAL,,,,2024-01-31,2024-02-28,ACTUAL,2020-02-07,ACTUAL,2020-02-07,2024-01,2024-01-31,2023-02-07,ACTUAL,2023-02-07,2023-02-07,ACTUAL,2023-02-07,,INTERVENTIONAL,,,Imaging CCR2 Receptors With 64Cu-DOTA-ECL1i in Head and Neck Cancer,Imaging CCR2 Receptors With 64Cu-DOTA-ECL1i in Head and Neck Cancer,TERMINATED,,PHASE1,11.0,ACTUAL,Washington University School of Medicine,,1.0,,Insufficient funding/staff,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:51:48.280969,2024-10-17 03:51:48.280969,OTHER,,,,,,,2023,0.0
NCT05012787,,2021-08-18,,,2023-03-22,2021-08-18,2021-08-19,ACTUAL,,,,,,,2023-03-22,2023-03-24,ACTUAL,2021-11-12,ACTUAL,2021-11-12,2023-03,2023-03-31,2022-05-04,ACTUAL,2022-05-04,2022-03-30,ACTUAL,2022-03-30,,INTERVENTIONAL,COVID-19,,Safety and Immunogenicity of Adjuvanted SARS-CoV-2 (SCB-2019) Vaccine in Adults With Chronic Immune-Mediated Diseases,"A Double-Blind, Randomized, Controlled, Phase 3 Study to Evaluate the Safety and Immunogenicity of CpG 1018/Alum-adjuvanted SCB-2019 in Individuals Aged 18 and Above With Chronic Immune-Mediated Inflammatory Diseases",TERMINATED,,PHASE3,1.0,ACTUAL,Clover Biopharmaceuticals AUS Pty Ltd,,2.0,,The study was early terminated considering the inability to enroll the required study population.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 07:35:53.059413,2024-10-15 07:35:53.059413,INDUSTRY,,,,,,,2022,0.0
NCT03815292,,2018-11-11,2020-12-17,,2021-02-05,2019-01-23,2019-01-24,ACTUAL,2021-02-05,2021-02-23,ACTUAL,,,,2021-02-05,2021-02-23,ACTUAL,2018-10-19,ACTUAL,2018-10-19,2019-08,2019-08-31,2020-01-27,ACTUAL,2020-01-27,2020-01-27,ACTUAL,2020-01-27,,INTERVENTIONAL,,,Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Mild Cognitive Impairment in Early Recovery Stage After Ischemic Stroke,Multicenter Double-blind Placebo-controlled Randomized Parallel-group Clinical Study of Efficacy and Safety of MMH-MAP in the Treatment of Mild Cognitive Impairment in Subjects in Early Rehabilitation Period of Ischemic Stroke,COMPLETED,,PHASE3,276.0,ACTUAL,Materia Medica Holding,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,INDUSTRY,,,,,,,2020,1.0
NCT03430843,,2018-01-29,2023-11-10,2021-11-23,2023-12-12,2018-02-06,2018-02-13,ACTUAL,2023-12-12,2023-12-29,ACTUAL,,2023-12-29,ACTUAL,2023-12-12,2023-12-29,ACTUAL,2018-01-26,ACTUAL,2018-01-26,2023-12,2023-12-31,2022-12-28,ACTUAL,2022-12-28,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,,,A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma,"A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma",COMPLETED,,PHASE3,512.0,ACTUAL,BeiGene,"The impact on treatment was considered very limited due to the small number of patients remaining on treatment, the short COVID-19 restriction period (in Asia), and limited restrictions for healthcare visits (in Europe/North America).",2.0,,,,,,,t,t,f,,,,,,,,,YES,,2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,INDUSTRY,,,,,,,2022,1.0
NCT05700630,,2022-12-09,,,2024-02-23,2023-01-17,2023-01-26,ACTUAL,,,,,,,2024-02-23,2024-02-26,ACTUAL,2024-07-15,ESTIMATED,2024-07-15,2024-02,2024-02-29,2024-08-21,ESTIMATED,2024-08-21,2024-07-26,ESTIMATED,2024-07-26,,INTERVENTIONAL,,,Ph1 Study of FT538 Alone and With Vorinostat for Persistent Low-Level HIV Viremia,MT2022-06: Phase I Study of FT538 Monotherapy and in Combination With Vorinostat for the Treatment of Persistent Low-Level HIV Viremia,WITHDRAWN,,PHASE1,0.0,ACTUAL,"Masonic Cancer Center, University of Minnesota",,2.0,,Abandoned,,,,,t,t,f,,,,,,,,,NO,Research related samples will be managed using established protocols in the Schacker Laboratory.,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,OTHER,,,,,,,2024,0.0
NCT03116347,,2017-04-12,2022-01-14,,2022-04-13,2017-04-12,2017-04-17,ACTUAL,2022-04-13,2023-01-11,ACTUAL,,,,2022-04-13,2023-01-11,ACTUAL,2017-05-30,ACTUAL,2017-05-30,2022-04,2022-04-30,2021-01-15,ACTUAL,2021-01-15,2021-01-15,ACTUAL,2021-01-15,,INTERVENTIONAL,,Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia.,"Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects","Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects With Primary Immunodeficiency Diseases",COMPLETED,,PHASE4,42.0,ACTUAL,Takeda,,3.0,,,f,,,,f,f,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,INDUSTRY,,,,,,,2021,1.0
NCT03315182,,2017-10-10,,,2022-04-29,2017-10-16,2017-10-20,ACTUAL,,,,,,,2022-04-29,2022-05-05,ACTUAL,2017-10-16,ACTUAL,2017-10-16,2022-04,2022-04-30,2022-04-07,ACTUAL,2022-04-07,2022-04-07,ACTUAL,2022-04-07,,INTERVENTIONAL,MPSIIIB,,Gene Transfer Clinical Trial for Mucopolysaccharidosis (MPS) IIIB,Phase I/II Gene Transfer Clinical Trial of rAAV9.CMV.hNAGLU for Mucopolysaccharidosis (MPS) IIIB,TERMINATED,,PHASE1/PHASE2,11.0,ACTUAL,"Abeona Therapeutics, Inc",,3.0,,Abeona has decided to discontinue development activities for Product ABO-101 due to a lack of drug supply and for business reasons unrelated to the product safety profile and/or signs of efficacy,f,,,,t,t,f,,,,,,,,,NO,There is no plan to share data,2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,INDUSTRY,,,,,,,2022,0.0
NCT03231722,,2017-07-03,,,2023-01-04,2017-07-24,2017-07-27,ACTUAL,,,,,,,2023-01-04,2023-01-05,ACTUAL,2017-09-13,ACTUAL,2017-09-13,2023-01,2023-01-31,2022-06-24,ACTUAL,2022-06-24,2022-06-15,ACTUAL,2022-06-15,,INTERVENTIONAL,TRIPLETE,,First Line mFOLFOXIRI + PANITUMUMAB vs mFOLFOX + PANITUMUMAB IN RAS AND BRAF WT METASTATIC COLORECTAL CANCER PATIENTS,The TRIPLETE Study RANDOMIZED PHASE III STUDY OF TRIPLET mFOLFOXIRI PLUS PANITUMUMAB Versus mFOLFOX6 PLUS PANITUMUMAB AS INITIAL THERAPY FOR UNRESECTABLE RAS AND BRAF WILDTYPE METASTATIC COLORECTAL CANCER PATIENTS,COMPLETED,,PHASE3,435.0,ACTUAL,Gruppo Oncologico del Nord-Ovest,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,OTHER,,,,,,,2022,1.0
NCT04951492,,2021-06-28,,,2023-12-07,2021-06-28,2021-07-06,ACTUAL,,,,,,,2023-12-07,2023-12-14,ACTUAL,2022-11-09,ACTUAL,2022-11-09,2023-12,2023-12-31,2023-10-15,ACTUAL,2023-10-15,2023-10-15,ACTUAL,2023-10-15,,INTERVENTIONAL,,,Olaparib for the Treatment of Castration Resistant Prostate Adenocarcinoma,Olaparib in Prostate Cancer Patients With Evidence of Homologous Recombination Deficiency as Assessed Using an Integrated Genomic Signature,TERMINATED,,PHASE2,2.0,ACTUAL,University of Washington,,1.0,,Withdrawal of funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,OTHER,,,,,,,2023,0.0
NCT03219164,,2017-07-13,2022-03-02,2021-08-10,2022-05-26,2017-07-13,2017-07-17,ACTUAL,2022-04-22,2022-05-16,ACTUAL,2022-04-22,2022-05-16,ACTUAL,2022-05-26,2022-06-14,ACTUAL,2017-11-28,ACTUAL,2017-11-28,2022-05,2022-05-31,2021-09-23,ACTUAL,2021-09-23,2020-05-27,ACTUAL,2020-05-27,,INTERVENTIONAL,ALPINE 2,Safety Analysis Set included participants who were randomized and received at least one dose of study drug.,Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria,"Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects With Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas Aeruginosa (PA) Infection/Colonization",TERMINATED,,PHASE3,149.0,ACTUAL,Gilead Sciences,"The study was terminated early due to Coronavirus disease 2019 (COVID-19) pandemic. At the time of study termination, all evaluable participants completed the initial eradication period and provided data for the primary analysis.",2.0,,Study was terminated early by sponsor due to the challenges and risks introduced by Coronavirus disease 2019 (COVID-19) pandemic.,f,,,,t,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gileadclinicaltrials.com/transparency-policy/,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/",2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,INDUSTRY,,,,,,,2021,0.0
NCT04437953,,2020-06-17,,,2020-12-04,2020-06-17,2020-06-18,ACTUAL,,,,,,,2020-12-04,2020-12-08,ACTUAL,2020-05-27,ACTUAL,2020-05-27,2020-12,2020-12-31,2020-12-03,ACTUAL,2020-12-03,2020-12-03,ACTUAL,2020-12-03,,INTERVENTIONAL,,,Avatrombopag for Thrombocytopenia in People With Cancer,"Clinical Trial of Avatrombopag for Thrombocytopenia in Cancer, A Phase II Single Arm Study",WITHDRAWN,,PHASE2,0.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,Lack of accrual,,,,,,t,f,,,,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,OTHER,,,,,,,2020,0.0
NCT05195528,,2022-01-04,2023-11-17,,2023-12-13,2022-01-04,2022-01-19,ACTUAL,2023-12-13,2023-12-29,ACTUAL,,,,2023-12-13,2023-12-29,ACTUAL,2022-01-17,ACTUAL,2022-01-17,2023-12,2023-12-31,2023-05-17,ACTUAL,2023-05-17,2022-11-21,ACTUAL,2022-11-21,,INTERVENTIONAL,,"Data is presented for the Placebo-controlled treatment Period, ITT population.",A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo for Relief of Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD),"A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 and 20 mg Compared to Placebo for Relief of Heartburn in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD) After 4 Weeks and to Evaluate the Efficacy and Safety of Vonoprazan 10 and 20 mg for Relief of Heartburn in Subjects With NERD After 6 Months",COMPLETED,,PHASE3,776.0,ACTUAL,"Phathom Pharmaceuticals, Inc.",,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,INDUSTRY,,,,,,,2023,1.0
NCT04270019,,2020-02-12,,,2024-01-03,2020-02-12,2020-02-17,ACTUAL,,,,,,,2024-01-03,2024-01-05,ACTUAL,2020-06-26,ACTUAL,2020-06-26,2024-01,2024-01-31,2023-09-15,ACTUAL,2023-09-15,2023-09-15,ACTUAL,2023-09-15,,INTERVENTIONAL,,,Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration,The Use of Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration: A Randomized Controlled Trial,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Nova Scotia Health Authority,,2.0,,"lack of staff, REB closed the file due to expired renewal",f,,,,t,f,f,,,f,,,,,,NO,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2023,0.0
NCT04094077,,2019-09-16,,,2021-06-03,2019-09-17,2019-09-18,ACTUAL,,,,,,,2021-06-03,2021-06-08,ACTUAL,2020-01-17,ACTUAL,2020-01-17,2021-06,2021-06-30,2021-02-24,ACTUAL,2021-02-24,2021-02-24,ACTUAL,2021-02-24,,INTERVENTIONAL,NANOSTEREO,,Evaluating AGuIX® Nanoparticles in Combination With Stereotactic Radiation for Brain Metastases,A Phase II Study Evaluating AGuIX® Nanoparticles in Combination With Stereotactic Radiation for Oligo Brain Metastases.,TERMINATED,,PHASE2,1.0,ACTUAL,Centre Leon Berard,,1.0,,Study stopped after a negative result delivred by the CPP for a substancial modification of the protocol,f,,,,t,f,f,,,,,,,,,,,2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,OTHER,,,,,,,2021,0.0
NCT04163718,,2019-11-12,2023-02-23,,2023-03-23,2019-11-12,2019-11-15,ACTUAL,2023-03-23,2023-03-24,ACTUAL,,,,2023-03-23,2023-03-24,ACTUAL,2019-11-12,ACTUAL,2019-11-12,2023-03,2023-03-31,2022-10-19,ACTUAL,2022-10-19,2022-10-19,ACTUAL,2022-10-19,,INTERVENTIONAL,,,TGR-1202 (Umbralisib) in Treatment Naïve Patients With Chronic Lymphocytic Leukemia (CLL),"A Phase 2 Study to Assess the Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Parameters of Umbralisib in Treatment Naïve Patients With Chronic Lymphocytic Leukemia (CLL)",TERMINATED,,PHASE2,12.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,1.0,,Drug no longer available,,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,OTHER,,,,,,,2022,0.0
NCT04373460,,2020-04-30,2022-12-21,,2023-05-31,2020-04-30,2020-05-04,ACTUAL,2023-01-18,2023-01-31,ACTUAL,,,,2023-05-31,2023-06-02,ACTUAL,2020-06-03,ACTUAL,2020-06-03,2023-01,2023-01-31,2022-12-14,ACTUAL,2022-12-14,2022-01-14,ACTUAL,2022-01-14,,INTERVENTIONAL,CSSC-004,Includes participants who were randomized and received transfusion,Convalescent Plasma to Limit SARS-CoV-2 Associated Complications,Comparison of the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune) Plasma Among Outpatients With Symptomatic COVID-19,COMPLETED,,PHASE2,1225.0,ACTUAL,Johns Hopkins University,,2.0,,,,,,,t,t,f,,,,,,After publication of initial study manuscript,Public,,YES,"Anonymized individual participant data (IPD) collected in this study, including data dictionaries, will be made available to other researchers after the end of the study.",2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2022,1.0
NCT04485429,,2020-07-20,,,2021-08-04,2020-07-23,2020-07-24,ACTUAL,,,,,,,2021-08-04,2021-08-11,ACTUAL,2020-07-20,ACTUAL,2020-07-20,2021-08,2021-08-31,2022-12-31,ESTIMATED,2022-12-31,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia,"Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia: A Randomized, Controlled, 2x2 Factorial Study",WITHDRAWN,,PHASE3,0.0,ACTUAL,D'Or Institute for Research and Education,,4.0,,It was not possible to perform the study due to the availability and logistics of porcine heparin,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,OTHER,,,,,,,2022,0.0
NCT04403685,,2020-05-24,,,2020-08-22,2020-05-24,2020-05-27,ACTUAL,,,,,,,2020-08-22,2020-08-26,ACTUAL,2020-05-08,ACTUAL,2020-05-08,2020-08,2020-08-31,2020-07-21,ACTUAL,2020-07-21,2020-07-08,ACTUAL,2020-07-08,,INTERVENTIONAL,TOCIBRAS,,Safety and Efficacy of Tocilizumab in Moderate to Severe COVID-19 With Inflammatory Markers,Safety and Efficacy of Tocilizumab in Moderate to Severe COVID-19 and Increased Inflammatory Markers: a Phase III Randomized Clinical Trial (COVID-19 Coalition Brazil VI) (TOCIBRAS),TERMINATED,,PHASE3,129.0,ACTUAL,Beneficência Portuguesa de São Paulo,,2.0,,Safety,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2020,0.0
NCT03345550,,2017-11-12,2022-07-26,,2023-04-27,2017-11-15,2017-11-17,ACTUAL,2023-04-27,2023-05-23,ACTUAL,,,,2023-04-27,2023-05-23,ACTUAL,2017-09-12,ACTUAL,2017-09-12,2023-04,2023-04-30,2021-07-27,ACTUAL,2021-07-27,2021-07-27,ACTUAL,2021-07-27,,INTERVENTIONAL,OPTIMA,,OPTIMA-TBI Pilot Study,Pilot Study of Omega-3 Polyunsaturated Fatty Acid Treatment in Mild Acute TBI (OPTIMA-TBI Pilot),TERMINATED,,PHASE2,44.0,ACTUAL,University of Michigan,,2.0,,"Slow accrual of patients, lack of financial resources",f,,,,f,t,f,,,t,,,,,,,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2021,0.0
NCT03823378,,2019-01-08,2021-08-18,,2021-08-18,2019-01-29,2019-01-30,ACTUAL,2021-08-18,2021-09-16,ACTUAL,,,,2021-08-18,2021-09-16,ACTUAL,2019-05-13,ACTUAL,2019-05-13,2021-08,2021-08-31,2020-09-09,ACTUAL,2020-09-09,2020-09-09,ACTUAL,2020-09-09,,INTERVENTIONAL,,Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763,A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib,"A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial With ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599)",TERMINATED,,PHASE2,97.0,ACTUAL,AbbVie,,6.0,,Study M16-763 was terminated early as the benefit of each treatment arm from the feeder study (Study M16-063) did not provide appreciable evidence of differentiated clinical effect to warrant further long-term continuation.,f,,,,t,t,f,,,t,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,INDUSTRY,,,,,,,2020,0.0
NCT04059198,,2019-08-14,,,2020-07-20,2019-08-14,2019-08-16,ACTUAL,,,,,,,2020-07-20,2020-07-21,ACTUAL,2019-10-10,ACTUAL,2019-10-10,2020-07,2020-07-31,2020-04-02,ACTUAL,2020-04-02,2020-04-02,ACTUAL,2020-04-02,,INTERVENTIONAL,,,Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic Treatment Naive Subjects Infected With Hepatitis B Virus,"A Phase 2, Exploratory Study Evaluating the Safety and Antiviral Efficacy of Inarigivir Soproxil in Non-cirrhotic Treatment-Naive Subjects Infected With Chronic Hepatitis B Virus",TERMINATED,,PHASE2,5.0,ACTUAL,"F-star Therapeutics, Inc.",,3.0,,Evidence of liver injury in a separate Inarigavir study,f,,,,t,f,f,,,,,,,,,,,2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,INDUSTRY,,,,,,,2020,0.0
NCT04227756,,2020-01-07,,,2024-01-23,2020-01-09,2020-01-14,ACTUAL,,,,,,,2024-01-23,2024-01-24,ACTUAL,2020-05-19,ACTUAL,2020-05-19,2024-01,2024-01-31,2022-09-02,ACTUAL,2022-09-02,2022-09-02,ACTUAL,2022-09-02,,INTERVENTIONAL,LPM,,"Comparative Acute Effects of LSD, Psilocybin and Mescaline","Comparative Acute Effects of LSD, Psilocybin and Mescaline in a Random-Order Placebo-Controlled Cross-Over Study in Healthy Subjects",COMPLETED,,PHASE1,32.0,ACTUAL,"University Hospital, Basel, Switzerland",,4.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2022,0.0
NCT03093402,,2017-02-21,2022-07-28,,2022-10-27,2017-03-22,2017-03-28,ACTUAL,2022-10-27,2022-11-18,ACTUAL,,,,2022-10-27,2022-11-18,ACTUAL,2017-12-21,ACTUAL,2017-12-21,2022-10,2022-10-31,2021-07-28,ACTUAL,2021-07-28,2021-07-28,ACTUAL,2021-07-28,,INTERVENTIONAL,,The modified-intent-to-treat population includes all randomized participants who received at least one dose of study drug.,JBT-101 in Systemic Lupus Erythematosus (SLE),"A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus",COMPLETED,,PHASE2,109.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,4.0,,,f,,,,t,t,f,,,,,,After completion of the study.,Data is available to the public once Individual Participant-Level data is posted to ImmPort.,http://www.immport.org/,YES,"The plan is to share data in ImmPort \[https://immport.niaid.nih.gov/ \], a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts, upon completion of the study.",2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,NIH,,,,,,,2021,1.0
NCT02285179,,2014-10-21,,,2022-10-11,2014-11-04,2014-11-06,ESTIMATED,,,,,,,2022-10-11,2022-10-12,ACTUAL,2014-11,ACTUAL,2014-11-30,2022-10,2022-10-31,2022-05-01,ACTUAL,2022-05-01,2022-05-01,ACTUAL,2022-05-01,,INTERVENTIONAL,Poseidon,,Clinical Trial to Evaluate the Safety and Effectiveness of GDC-0032 When Given Alongside Tamoxifen,Phase I/Prospective Randomized Phase II Trial Of the Safety and Efficacy of Tamoxifen in Combination With GDC-0032 Compared With Tamoxifen alONe.,COMPLETED,,PHASE1/PHASE2,189.0,ACTUAL,The Netherlands Cancer Institute,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2022,1.0
NCT03739840,,2018-11-09,2021-09-24,,2022-12-19,2018-11-09,2018-11-14,ACTUAL,2021-09-24,2021-10-25,ACTUAL,,,,2022-12-19,2022-12-21,ACTUAL,2019-03-06,ACTUAL,2019-03-06,2022-12,2022-12-31,2020-09-28,ACTUAL,2020-09-28,2020-09-28,ACTUAL,2020-09-28,,INTERVENTIONAL,DUET,Baseline Characteristics refer to the Randomized Set (RS) consisted of all participants randomized into the study.,A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy",TERMINATED,,PHASE3,232.0,ACTUAL,UCB Pharma,,4.0,,"Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure",f,,,,t,t,f,,,,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",http://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,INDUSTRY,,,,,,,2020,0.0
NCT04811573,,2021-03-22,2022-08-12,,2022-08-12,2021-03-22,2021-03-23,ACTUAL,2022-08-12,2023-08-31,ACTUAL,,,,2022-08-12,2023-08-31,ACTUAL,2021-03-31,ACTUAL,2021-03-31,2022-08,2022-08-31,2021-08-18,ACTUAL,2021-08-18,2021-08-18,ACTUAL,2021-08-18,,INTERVENTIONAL,,Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.,A Study in Healthy People to Compare 3 Different Formulations of Apremilast Tablets Taken With or Without Food,"Bioequivalence of Three Different Tablet Formulations of 30 mg of Apremilast (EU-sourced Otezla® vs. US-sourced Otezla® vs. Japan-sourced Otezla®) Administered in Healthy Male and Female Subjects in the Fasted State as Well as (for EU-sourced Otezla® vs. US-sourced Otezla®) in the Fed State (an Open-label, Randomised, Single-dose, Five-period, Ten-sequence Crossover Study)",TERMINATED,,PHASE1,20.0,ACTUAL,Boehringer Ingelheim,This trial was prematurely discontinued due to sponsor decision. The planned recruitment amount was not reached. The planned statistical analyses of the pharmacokinetic parameters were not performed.,10.0,,due to company decision,f,,,,f,t,f,,,t,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,INDUSTRY,,,,,,,2021,0.0
NCT03950037,,2019-05-13,,,2022-04-04,2019-05-13,2019-05-15,ACTUAL,,,,,,,2022-04-04,2022-04-12,ACTUAL,2022-01-01,ESTIMATED,2022-01-01,2022-04,2022-04-30,2023-04,ESTIMATED,2023-04-30,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,,,SANCC: Clinical Trial Early Intervention,An Open-label Non-randomized Phase IIa Trial to Evaluate Safety of Early Intervention in Asymptomatic Subarachnoid Neurocysticercosis,WITHDRAWN,,PHASE2,0.0,ACTUAL,Oregon Health and Science University,,1.0,,Unable to complete due to SARS-CoV-2 pandemic,f,,,,t,f,f,,,,,,6 months after trial completion,Data access requests will be reviewed by the principal investigators. Requestors will be required to sign a Data Use Agreement.,,YES,Anonymized patient data for primary and secondary outcomes will be made available.,2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,OTHER,,,,,,,2023,0.0
NCT02495103,,2015-07-08,2021-01-12,,2021-01-12,2015-07-08,2015-07-13,ESTIMATED,2021-01-12,2021-01-26,ACTUAL,,,,2021-01-12,2021-01-26,ACTUAL,2015-08-26,ACTUAL,2015-08-26,2021-01,2021-01-31,2020-02-06,ACTUAL,2020-02-06,2020-02-06,ACTUAL,2020-02-06,,INTERVENTIONAL,,,Vandetanib in Combination With Metformin in People With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma,Phase I/II Trial of Vandetanib in Combination With Metformin in Subjects With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma,TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,Vandetanib is no longer available as Sanofi has decided not to provide additional drug. All subjects are off-study.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,NIH,,,,,,,2020,0.0
NCT04428775,,2020-06-03,,,2021-11-01,2020-06-10,2020-06-11,ACTUAL,,,,,,,2021-11-01,2021-11-08,ACTUAL,2020-09-08,ACTUAL,2020-09-08,2021-06,2021-06-30,2021-10-01,ACTUAL,2021-10-01,2021-10-01,ACTUAL,2021-10-01,,INTERVENTIONAL,,,A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease,"A Phase IIa, Randomized, Open-label, Multi-Center, Multi-Dose Study to Evaluate the Effects of ALZT-OP1a in Subjects With Mild-Moderate Stage Amyotrophic Lateral Sclerosis (ALS)",TERMINATED,,PHASE2,12.0,ACTUAL,"AZTherapies, Inc.",,2.0,,Low enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,INDUSTRY,,,,,,,2021,0.0
NCT04322214,,2019-12-10,,,2020-07-21,2020-03-25,2020-03-26,ACTUAL,,,,,,,2020-07-21,2020-07-22,ACTUAL,2020-01-30,ACTUAL,2020-01-30,2020-07,2020-07-31,2020-04-30,ACTUAL,2020-04-30,2020-03-30,ACTUAL,2020-03-30,,INTERVENTIONAL,GHB_Cobi,,Clinical Trial to Evaluate Pharmacological Interactions Between γ-hydroxybutyrate (GHB) and Cobicistat,Clinical Trial to Evaluate Pharmacological Interactions Between γ-hydroxybutyrate (GHB) and Cobicistat,COMPLETED,,PHASE1,12.0,ACTUAL,"Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia",,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,OTHER,,,,,,,2020,1.0
NCT03884465,,2019-03-04,,,2021-09-03,2019-03-18,2019-03-21,ACTUAL,,,,,,,2021-09-03,2021-09-13,ACTUAL,2019-11-11,ACTUAL,2019-11-11,2021-09,2021-09-30,2020-12-23,ACTUAL,2020-12-23,2020-12-23,ACTUAL,2020-12-23,,INTERVENTIONAL,,,Hemodynamic Evaluation of Dose-response and Safety of Dry Powder Inhalation of Treprostinil,"A Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects",TERMINATED,,PHASE2,15.0,ACTUAL,"Liquidia Technologies, Inc.",,1.0,,COVID,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,INDUSTRY,,,,,,,2020,0.0
NCT03481660,,2018-03-19,2022-05-17,,2024-02-27,2018-03-27,2018-03-29,ACTUAL,2023-04-04,2024-01-05,ACTUAL,,,,2024-02-27,2024-02-29,ACTUAL,2018-07-27,ACTUAL,2018-07-27,2024-02,2024-02-29,2021-06-08,ACTUAL,2021-06-08,2020-06-29,ACTUAL,2020-06-29,,INTERVENTIONAL,KITE,,A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema,"A Two-Year, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Diabetic Macular Edema",COMPLETED,,PHASE3,360.0,ACTUAL,Novartis,,2.0,,,f,,,,t,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,INDUSTRY,,,,,,,2021,1.0
NCT03024437,,2017-01-16,,,2022-10-29,2017-01-16,2017-01-18,ESTIMATED,,,,,,,2022-10-29,2022-11-01,ACTUAL,2017-06-29,ACTUAL,2017-06-29,2022-10,2022-10-31,2024-06-30,ESTIMATED,2024-06-30,2023-06-30,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,Atezolizumab in Combination With Entinostat and Bevacizumab in Patients With Advanced Renal Cell Carcinoma,"A Phase I/II Study to Evaluate the Safety, Pharmacodynamics and Efficacy of Atezolizumab in Combination With Entinostat and Bevacizumab in Patients With Advanced Renal Cell Carcinoma",SUSPENDED,,PHASE1/PHASE2,72.0,ESTIMATED,Indiana University,,3.0,,Major review underway,f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,OTHER,,,,,,,2024,0.0
NCT04726332,,2021-01-22,,,2024-05-13,2021-01-22,2021-01-27,ACTUAL,,,,,,,2024-05-13,2024-05-14,ACTUAL,2021-02-10,ACTUAL,2021-02-10,2024-05,2024-05-31,2024-05-02,ACTUAL,2024-05-02,2024-05-02,ACTUAL,2024-05-02,,INTERVENTIONAL,,,Study of XL102 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (QUARTZ-101),A Dose Escalation and Expansion Study of the Safety and Pharmacokinetics of XL102 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors,TERMINATED,,PHASE1,52.0,ACTUAL,Exelixis,,6.0,,Business reasons,f,,,,f,t,f,,,,,,,,,,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,INDUSTRY,,,,,,,2024,0.0
NCT03388814,,2017-12-19,,,2018-11-28,2017-12-29,2018-01-03,ACTUAL,,,,,,,2018-11-28,2018-11-30,ACTUAL,2018-11,ESTIMATED,2018-11-30,2018-11,2018-11-30,2020-06,ESTIMATED,2020-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,Speeding Recovery From Pain and Opioid Use,Speeding Recovery From Pain and Opioid Use After Mastectomy and Breast Reconstruction Surgery,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,Lack of Funding,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2020,0.0
NCT04167345,,2019-11-15,2022-01-07,,2022-01-07,2019-11-15,2019-11-18,ACTUAL,2022-01-07,2022-02-02,ACTUAL,,,,2022-01-07,2022-02-02,ACTUAL,2020-01-13,ACTUAL,2020-01-13,2022-01,2022-01-31,2020-11-14,ACTUAL,2020-11-14,2020-11-14,ACTUAL,2020-11-14,,INTERVENTIONAL,,,Evaluation of the Efficacy and Safety of VX-814 in Subjects With the PiZZ Genotype,"A Phase 2, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of VX-814 in PiZZ Subjects",TERMINATED,,PHASE2,48.0,ACTUAL,Vertex Pharmaceuticals Incorporated,"During the study, elevated liver enzymes (AST/ALT) were observed in several participants and analysis of available pharmacokinetics data indicated that VX-814 exposures achieved were low. Based on these data, Vertex concluded that it would not be feasible to safely reach targeted exposure levels with VX-814. Thus, the study was terminated early at the sponsor's discretion. Given the study was terminated early, the data are incomplete, and results should be interpreted with caution.",5.0,,at Sponsor's discretion,f,,,,,t,f,,,,,,,,,NO,Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,INDUSTRY,,,,,,,2020,0.0
NCT04806035,,2021-03-05,,,2024-07-29,2021-03-16,2021-03-19,ACTUAL,,,,,,,2024-07-29,2024-07-31,ACTUAL,2021-04-28,ACTUAL,2021-04-28,2024-07,2024-07-31,2024-06-12,ACTUAL,2024-06-12,2024-06-12,ACTUAL,2024-06-12,,INTERVENTIONAL,,,Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia,A Phase 1b Multi-cohort Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia,TERMINATED,,PHASE1,21.0,ACTUAL,"TG Therapeutics, Inc.",,3.0,,Strategic/Business Decision,f,,,,f,t,f,,,,,,,,,,,2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,INDUSTRY,,,,,,,2024,0.0
NCT05219864,,2022-01-21,,,2022-11-14,2022-01-21,2022-02-02,ACTUAL,,,,,,,2022-11-14,2022-11-17,ACTUAL,2023-01-31,ESTIMATED,2023-01-31,2022-11,2022-11-30,2024-09-22,ESTIMATED,2024-09-22,2024-04-25,ESTIMATED,2024-04-25,,INTERVENTIONAL,TRuE-CHE1,,Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1,"Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1 (TRuE-CHE1): A Phase 3, Double-Blind, Randomized, 16-Week, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Open-Label Extension Period in Adults With Chronic Hand Eczema",WITHDRAWN,,PHASE3,0.0,ACTUAL,Incyte Corporation,,2.0,,Business decision; no safety concerns.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,INDUSTRY,,,,,,,2024,0.0
NCT04344288,,2020-04-10,,,2020-10-23,2020-04-10,2020-04-14,ACTUAL,,,,,,,2020-10-23,2020-10-26,ACTUAL,2020-04-21,ACTUAL,2020-04-21,2020-10,2020-10-31,2020-08-18,ACTUAL,2020-08-18,2020-08-18,ACTUAL,2020-08-18,,INTERVENTIONAL,CORTI-Covid,,Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection,Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection,TERMINATED,,PHASE2,11.0,ACTUAL,Hospices Civils de Lyon,,2.0,,Competent Authority's decision,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,OTHER,,,,,,,2020,0.0
NCT04776044,,2021-02-26,,,2022-09-20,2021-02-26,2021-03-01,ACTUAL,,,,,,,2022-09-20,2022-09-22,ACTUAL,2021-04-12,ACTUAL,2021-04-12,2022-09,2022-09-30,2022-08-09,ACTUAL,2022-08-09,2022-06-06,ACTUAL,2022-06-06,,INTERVENTIONAL,RESPIRE,,Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients With COVID-19,"RESPIRE - A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients With COVID-19",TERMINATED,,PHASE2,133.0,ACTUAL,Atriva Therapeutics GmbH,,2.0,,general circumstances around COVID-19 and current availability of hospitalized patients,f,,,,t,f,f,,,,,,,,,,,2024-10-15 07:41:39.398824,2024-10-15 07:41:39.398824,INDUSTRY,,,,,,,2022,0.0
NCT04068610,,2019-08-01,2023-10-06,,2023-11-13,2019-08-23,2019-08-28,ACTUAL,2023-11-13,2023-11-15,ACTUAL,,,,2023-11-13,2023-11-15,ACTUAL,2019-09-13,ACTUAL,2019-09-13,2023-11,2023-11-30,2022-10-10,ACTUAL,2022-10-10,2022-10-10,ACTUAL,2022-10-10,,INTERVENTIONAL,,As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.,COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC,"A Phase Ib/II, Open-label, Multicenter Study of Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First-line Therapy in Metastatic Microsatellite-stable Colorectal Cancer (COLUMBIA-1)",TERMINATED,,PHASE1/PHASE2,61.0,ACTUAL,MedImmune LLC,"On 17 February 2022, the decision was made to terminate the clinical study because superior efficacy was not observed for the novel study drug combinations under investigation.",3.0,,"On 17 February 2022, the decision was made to terminate the clinical study because superior efficacy was not observed for the novel study drug combinations under investigation.",f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,INDUSTRY,,,,,,,2022,0.0
NCT04228783,,2020-01-10,2023-04-24,,2023-06-02,2020-01-10,2020-01-14,ACTUAL,2023-04-24,2023-05-17,ACTUAL,,,,2023-06-02,2023-06-05,ACTUAL,2020-02-18,ACTUAL,2020-02-18,2023-06,2023-06-30,2022-04-25,ACTUAL,2022-04-25,2022-04-25,ACTUAL,2022-04-25,,INTERVENTIONAL,,,A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants,"A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, Reactogenicity, and Consistency of a Heterologous 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN®-Filo in Adult Participants",COMPLETED,,PHASE3,974.0,ACTUAL,Janssen Vaccines & Prevention B.V.,,6.0,,,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,INDUSTRY,,,,,,,2022,1.0
NCT04671836,,2020-12-11,,,2022-05-23,2020-12-11,2020-12-17,ACTUAL,,,,,,,2022-05-23,2022-05-27,ACTUAL,2022-01,ESTIMATED,2022-01-31,2022-05,2022-05-31,2022-12,ESTIMATED,2022-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Lorazepam Effects on Neuroimaging Measures,Lorazepam Effects on Neuroimaging Measures: A Pilot Study,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Northwell Health,,2.0,,No longer interested in conducing study,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2022,0.0
NCT02787005,,2016-05-26,2023-02-23,,2023-02-23,2016-05-26,2016-06-01,ESTIMATED,2023-02-23,2023-03-24,ACTUAL,,,,2023-02-23,2023-03-24,ACTUAL,2016-07-01,ACTUAL,2016-07-01,2023-02,2023-02-28,2022-02-28,ACTUAL,2022-02-28,2022-02-28,ACTUAL,2022-02-28,,INTERVENTIONAL,,,Study of Pembrolizumab (MK-3475) in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)(MK-3475-199/KEYNOTE-199),Phase II Trial of Pembrolizumab (MK-3475) in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-199),COMPLETED,,PHASE2,388.0,ACTUAL,Merck Sharp & Dohme LLC,,5.0,,,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,INDUSTRY,,,,,,,2022,1.0
NCT05079789,,2021-10-02,,,2023-07-01,2021-10-02,2021-10-15,ACTUAL,,,,,,,2023-07-01,2023-07-05,ACTUAL,2020-06-08,ACTUAL,2020-06-08,2023-07,2023-07-31,2022-11-20,ACTUAL,2022-11-20,2022-11-05,ACTUAL,2022-11-05,,INTERVENTIONAL,AMILOR,,Amiloride in Nephrotic Syndrome,"Randomized, Controlled Interventional Trial to Investigate the Efficacy of Amiloride for the Treatment of Edema in Human Nephrotic Syndrome",TERMINATED,,PHASE3,20.0,ACTUAL,University Hospital Tuebingen,,2.0,,Low recruiting rate and decision to evaluate as pilot study,f,,,,f,f,f,,,,,,,,,,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2022,0.0
NCT04030000,,2019-04-05,,,2023-03-14,2019-07-19,2019-07-23,ACTUAL,,,,,,,2023-03-14,2023-03-17,ACTUAL,2020-05-20,ACTUAL,2020-05-20,2023-03,2023-03-31,2023-01-30,ACTUAL,2023-01-30,2022-08-30,ACTUAL,2022-08-30,,INTERVENTIONAL,,,Uterine Serous Carcinoma and Adjuvant Combined Intraperitoneal Chemotherapy and Radiation,A Pilot Phase II Trial of Intravenous Paclitaxel and Intraperitoneal Carboplatin/Taxol Followed by Radiation in Patients With Advanced Stage Uterine Serous Carcinoma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Northwell Health,,1.0,,could not enroll anyone due to staff changes,,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2023,0.0
NCT02663895,,2016-01-19,2021-05-13,,2021-06-08,2016-01-21,2016-01-26,ESTIMATED,2021-06-08,2021-06-10,ACTUAL,,,,2021-06-08,2021-06-10,ACTUAL,2016-10,,2016-10-31,2021-06,2021-06-30,2020-05-13,ACTUAL,2020-05-13,2020-05-13,ACTUAL,2020-05-13,,INTERVENTIONAL,,,Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis,A Pilot Study to Evaluate the Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis,COMPLETED,,PHASE2,12.0,ACTUAL,Stanford University,,1.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2020,0.0
NCT02914522,,2016-09-22,2021-03-23,,2021-03-23,2016-09-22,2016-09-26,ESTIMATED,2021-03-23,2021-04-21,ACTUAL,,,,2021-03-23,2021-04-21,ACTUAL,2016-11-14,ACTUAL,2016-11-14,2021-03,2021-03-31,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,SELECTION,Safety Analysis Set for the Induction Study (Cohorts A and B) included all participants who took at least 1 dose of study drug in the Induction Study.,Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis,"Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis",COMPLETED,,PHASE3,1351.0,ACTUAL,Gilead Sciences,,11.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,INDUSTRY,,,,,,,2020,1.0
NCT02667327,,2016-01-26,,,2020-05-27,2016-01-27,2016-01-28,ESTIMATED,,,,,,,2020-05-27,2020-05-29,ACTUAL,2018-11-21,ACTUAL,2018-11-21,2020-05,2020-05-31,2020-05-27,ACTUAL,2020-05-27,2020-05-27,ACTUAL,2020-05-27,,INTERVENTIONAL,,,A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer,"A Phase 3, Randomized, Double-blind, Parallel-group, Vehicle Controlled, Multicenter Study of the Efficacy and Safety of Granexin Gel in the Treatment of Diabetic Foot Ulcer (GAIT 1)",TERMINATED,,PHASE3,124.0,ACTUAL,"Xequel Bio, Inc.",,3.0,,Sponsor Decision (No safety or efficacy concerns),f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,OTHER,,,,,,,2020,0.0
NCT01711242,,2012-10-14,,,2022-04-29,2012-10-17,2012-10-22,ESTIMATED,,,,,,,2022-04-29,2022-05-05,ACTUAL,2012-01,ACTUAL,2012-01-31,2022-04,2022-04-30,2021-01,ACTUAL,2021-01-31,2020-01,ACTUAL,2020-01-31,,INTERVENTIONAL,,,Trial of Adjuvant XELOX Chemotherapy and Concurrent Capecitabine and Radiotherapy for Resected Gastric Carcinoma,Phase II Randomized Trial of Adjuvant XELOX Chemotherapy and XELOX With Concurrent Capecitabine and Radiotherapy for Gastric Adenocarcinoma With D2 Dissection,COMPLETED,,PHASE2,208.0,ACTUAL,Wenzhou Medical University,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2021,1.0
NCT04478825,,2020-07-16,,,2021-09-27,2020-07-16,2020-07-21,ACTUAL,,,,,,,2021-09-27,2021-10-01,ACTUAL,2021-06-01,ACTUAL,2021-06-01,2021-09,2021-09-30,2021-08-24,ACTUAL,2021-08-24,2021-08-04,ACTUAL,2021-08-04,,INTERVENTIONAL,,,Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis,"An Open Label, Proof of Mechanism Study to Explore the Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis",TERMINATED,,PHASE1,2.0,ACTUAL,"Bridge Biotherapeutics, Inc.",,1.0,,Internal Company Decision,f,,,,,t,f,,,f,,,,,,,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,INDUSTRY,,,,,,,2021,0.0
NCT03693170,,2018-09-17,2022-01-13,,2024-01-31,2018-10-01,2018-10-02,ACTUAL,2022-08-08,2022-08-30,ACTUAL,,,,2024-01-31,2024-02-02,ACTUAL,2019-01-17,ACTUAL,2019-01-17,2024-01,2024-01-31,2023-04-27,ACTUAL,2023-04-27,2020-06-29,ACTUAL,2020-06-29,,INTERVENTIONAL,ANCHOR-CRC,,"Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer","Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer",COMPLETED,,PHASE2,95.0,ACTUAL,Pierre Fabre Medicament,"The absence of a comparator arm should be noted as a limitation. In addition, the short duration of the follow-up at the data cut-off date does not allow a robust estimate of OS results.",1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,INDUSTRY,,,,,,,2023,1.0
NCT02393690,,2015-03-16,2021-07-13,,2024-06-27,2015-03-16,2015-03-19,ESTIMATED,2021-07-13,2021-08-03,ACTUAL,,,,2024-06-27,2024-07-26,ACTUAL,2015-05-04,ACTUAL,2015-05-04,2024-06,2024-06-30,2023-12-31,ACTUAL,2023-12-31,2020-07-17,ACTUAL,2020-07-17,,INTERVENTIONAL,,All patients registered to protocol treatment are included in this analysis.,Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer,Randomized Double-Blind Phase II Study of Radioactive Iodine (RAI) in Combination With Placebo or Selumetinib for the Treatment of RAI-Avid Recurrent/Metastatic Thyroid Cancers,COMPLETED,,PHASE2,60.0,ACTUAL,Academic and Community Cancer Research United,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,OTHER,,,,,,,2023,1.0
NCT04325503,,2020-03-24,2023-08-09,,2024-04-02,2020-03-25,2020-03-27,ACTUAL,2023-09-05,2023-09-28,ACTUAL,,,,2024-04-02,2024-04-04,ACTUAL,2021-02-08,ACTUAL,2021-02-08,2024-04,2024-04-30,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,RES,,Neurobiological Drivers of Mobility Resilience: The Dopaminergic System,Neurobiological Drivers of Mobility Resilience: The Dopaminergic System,COMPLETED,,PHASE1/PHASE2,14.0,ACTUAL,University of Michigan,,1.0,,,f,,,,f,t,f,,,f,,,,,,NO,Results will be provided in publications,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2022,1.0
NCT03024216,,2017-01-09,,,2021-05-24,2017-01-13,2017-01-18,ESTIMATED,,,,,,,2021-05-24,2021-05-26,ACTUAL,2017-02-06,ACTUAL,2017-02-06,2021-05,2021-05-31,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Clinical Study of Atezolizumab (Anti-PD-L1) and Sipuleucel-T in Patients With Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer,Phase Ib Study Assessing Different Sequencing Regimens of Atezolizumab (Anti-PD-L1) and Sipuleucel-T in Patients Who Have Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer,COMPLETED,,PHASE1,37.0,ACTUAL,University of Hawaii,,2.0,,,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 05:40:52.072224,2024-10-16 05:40:52.072224,OTHER,,,,,,,2020,1.0
NCT04348890,,2020-04-13,,,2020-09-25,2020-04-13,2020-04-16,ACTUAL,,,,,,,2020-09-25,2020-09-29,ACTUAL,2020-09-01,ESTIMATED,2020-09-01,2020-09,2020-09-30,2022-09-01,ESTIMATED,2022-09-01,2022-09-01,ESTIMATED,2022-09-01,,INTERVENTIONAL,,,Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis,"A Phase I/II Open-Label, Proof-of-Concept Study of Vamorolone in Children and Adolescents With Mild-Moderately Active Ulcerative Colitis",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"ReveraGen BioPharma, Inc.",,1.0,,Programmatic decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,INDUSTRY,,,,,,,2022,0.0
NCT02961218,,2016-10-20,2020-10-27,2019-10-28,2021-10-07,2016-11-08,2016-11-10,ESTIMATED,2020-11-23,2020-12-17,ACTUAL,2020-11-23,2020-12-17,ACTUAL,2021-10-07,2021-10-11,ACTUAL,2017-04-05,ACTUAL,2017-04-05,2021-10,2021-10-31,2020-04-27,ACTUAL,2020-04-27,2019-06-27,ACTUAL,2019-06-27,,INTERVENTIONAL,,,"Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia","A Multiple-dose, Subject- and Investigator-blinded, Placebo-controlled, Parallel Design Study to Assess the Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia",COMPLETED,,PHASE2,49.0,ACTUAL,Novartis,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,INDUSTRY,,,,,,,2020,1.0
NCT05293509,,2022-03-04,,,2023-09-18,2022-03-14,2022-03-24,ACTUAL,,,,,,,2023-09-18,2023-09-21,ACTUAL,2022-03-02,ACTUAL,2022-03-02,2023-09,2023-09-30,2023-09-18,ACTUAL,2023-09-18,2023-09-18,ACTUAL,2023-09-18,,INTERVENTIONAL,,,Pharmacologic Pretransplant Immunosuppression (PTIS) + Reduced Toxicity Conditioning (RTC) Allogeneic Stem Cell Transplantation in Inherited Hematologic Disorders,Pharmacologic Pretransplant Immunosuppression (PTIS) + Reduced Toxicity Conditioning (RTC) Allogeneic Stem Cell Transplantation in Inherited Hematologic Disorders,WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,0 accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,OTHER,,,,,,,2023,0.0
NCT03208231,,2017-06-30,2023-04-27,2021-01-31,2023-04-27,2017-06-30,2017-07-05,ACTUAL,2023-04-27,2023-05-24,ACTUAL,2021-01-31,2021-02-04,ACTUAL,2023-04-27,2023-05-24,ACTUAL,2018-08-06,ACTUAL,2018-08-06,2023-04,2023-04-30,2021-02-11,ACTUAL,2021-02-11,2020-06-16,ACTUAL,2020-06-16,,INTERVENTIONAL,,,Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in Infants With HIV Receiving Combination Antiretroviral Therapy,"Phase I/II Multisite, Randomized, Controlled Study of Monoclonal Antibody VRC01 With Combination Antiretroviral Therapy to Promote Clearance of HIV-1-Infected Cells in Infants",COMPLETED,,PHASE1/PHASE2,61.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),"Accrual into the study was terminated early due to the outbreak of coronavirus disease 2019 (COVID-19), with 60 evaluable infants out of the targeted 68.",2.0,,,f,,,,t,t,f,,,,,,Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.,* With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.~* For what types of analyses? To achieve aims in the proposal approved by the IMPAACT Network.~* By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT Data Request form at: https://www.impaactnetwork.org/studies/submit-research-proposal. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.,https://www.impaactnetwork.org/,YES,"Individual participant data that underlie results in the publication, after deidentification.",2024-10-16 05:46:10.498183,2024-10-16 05:46:10.498183,NIH,,,,,,,2021,1.0
NCT02133521,,2014-05-07,,,2023-12-05,2014-05-07,2014-05-08,ESTIMATED,,,,,,,2023-12-05,2023-12-12,ACTUAL,2014-11-11,ACTUAL,2014-11-11,2023-12,2023-12-31,2023-04-21,ACTUAL,2023-04-21,2023-02-21,ACTUAL,2023-02-21,,INTERVENTIONAL,ADDLIST,,DLBS1033 for Acute Ischemic Stroke Patients,Addition of DLBS1033 to Standard Therapy for Acute Ischemic Stroke Patients,TERMINATED,,PHASE2/PHASE3,80.0,ACTUAL,Dexa Medica Group,,2.0,,"Very low recruitment rate. The Study Sites classified as tertiary referral hospital. Therefore, patients being referred to the site are mostly those with comorbidities included in the exclusion criteria.",f,,,,t,,,,,,,,,,,,,2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,INDUSTRY,,,,,,,2023,0.0
NCT03439943,,2018-02-13,,,2023-06-19,2018-02-13,2018-02-20,ACTUAL,,,,,,,2023-06-19,2023-06-22,ACTUAL,2018-06-13,ACTUAL,2018-06-13,2023-06,2023-06-30,2021-04-15,ACTUAL,2021-04-15,2021-04-15,ACTUAL,2021-04-15,,INTERVENTIONAL,LixiPark,,Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease,"Multicenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's Disease",COMPLETED,,PHASE2,156.0,ACTUAL,"University Hospital, Toulouse",,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,OTHER,,,,,,,2021,1.0
NCT03759288,,2018-11-20,,,2023-11-20,2018-11-28,2018-11-29,ACTUAL,,,,,,,2023-11-20,2023-11-21,ACTUAL,2018-12-07,ACTUAL,2018-12-07,2023-10,2023-10-31,2023-10-18,ACTUAL,2023-10-18,2023-10-18,ACTUAL,2023-10-18,,INTERVENTIONAL,INTREPID,,An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease,"A 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID Lead-In)",TERMINATED,,PHASE2/PHASE3,89.0,ACTUAL,AstraZeneca,,6.0,,Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,INDUSTRY,,,,,,,2023,0.0
NCT05086744,,2021-09-28,,2024-06-03,2024-06-03,2021-10-08,2021-10-21,ACTUAL,,,,,2024-03-06,ACTUAL,2024-06-03,2024-06-07,ACTUAL,2021-12-21,ACTUAL,2021-12-21,2024-06,2024-06-30,2024-05-17,ACTUAL,2024-05-17,2023-09-20,ACTUAL,2023-09-20,,INTERVENTIONAL,,,"Basket Study to Assess Efficacy, Safety and PK of Iptacopan (LNP023) in Autoimmune Benign Hematological Disorders","An Open-label, Multi-center, Phase 2 Basket Study to Assess Efficacy, Safety and Pharmacokinetics of Iptacopan (LNP023) in Participants With Autoimmune Benign Hematological Disorders",TERMINATED,,PHASE2,19.0,ACTUAL,Novartis,,1.0,,Business decision,,,,,,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient level data and supporting clinical documents from applicable studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,INDUSTRY,,,,,,,2024,0.0
NCT03862716,,2019-02-25,,,2023-10-24,2019-03-01,2019-03-05,ACTUAL,,,,,,,2023-10-24,2023-10-25,ACTUAL,2019-04-23,ACTUAL,2019-04-23,2023-10,2023-10-31,2023-07-31,ACTUAL,2023-07-31,2022-06-15,ACTUAL,2022-06-15,,INTERVENTIONAL,REMITiDegLira,,Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira,Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira (REMIT IDegLira): A Randomized Controlled Trial,COMPLETED,,PHASE3,159.0,ACTUAL,Population Health Research Institute,,2.0,,,f,,,,f,f,f,,,f,,,,,,,,2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,OTHER,,,,,,,2023,1.0
NCT03705390,,2018-09-11,,,2021-10-04,2018-10-10,2018-10-15,ACTUAL,,,,,,,2021-10-04,2021-10-05,ACTUAL,2019-03-29,ACTUAL,2019-03-29,2021-10,2021-10-31,2021-07-28,ACTUAL,2021-07-28,2021-07-28,ACTUAL,2021-07-28,,INTERVENTIONAL,ALS,,A Safety and Tolerability Study of ILB in Patients With Amyothrophic Lateral Sclerosis (ALS),A Phase II Pilot Single-arm Safety and Tolerability Study of ILB in Patients With Motor Neurone Disease (MND)/ Amyotrophic Lateral Sclerosis (ALS),COMPLETED,,PHASE2,11.0,ACTUAL,University of Birmingham,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 05:46:10.498183,2024-10-16 05:46:10.498183,OTHER,,,,,,,2021,1.0
NCT02797119,,2016-05-17,,,2022-06-14,2016-06-10,2016-06-13,ESTIMATED,,,,,,,2022-06-14,2022-06-21,ACTUAL,2016-03-15,ACTUAL,2016-03-15,2022-06,2022-06-30,2021-04-15,ACTUAL,2021-04-15,2021-04-15,ACTUAL,2021-04-15,,INTERVENTIONAL,TRACES,,Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery,Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery: a Multicenter Randomized Double Blind Placebo Controlled Therapeutic and Pharmaco-biological Dose Ranging Study (TRACES) for Its Optimal Benefit/Risk,TERMINATED,,PHASE4,225.0,ACTUAL,"University Hospital, Lille",,4.0,,Study will be stopped due to the impossibility of reaching the objective of inclusions within a reasonable time frame and taking into account the recommendations of the international WOMAN study,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 05:46:10.498183,2024-10-16 05:46:10.498183,OTHER,,,,,,,2021,0.0
NCT04558281,,2020-09-13,2023-04-24,,2023-05-17,2020-09-21,2020-09-22,ACTUAL,2023-05-17,2023-06-12,ACTUAL,,,,2023-05-17,2023-06-12,ACTUAL,2021-05-23,ACTUAL,2021-05-23,2023-05,2023-05-31,2023-03-24,ACTUAL,2023-03-24,2022-03-26,ACTUAL,2022-03-26,,INTERVENTIONAL,,,Continuous Erector Spinae Plane Blocks for Rib Fractures,Continuous Erector Spinae Plane Blocks for Analgesia and Improving Incentive Spirometry Following Traumatic Rib Fractures,TERMINATED,,PHASE4,4.0,ACTUAL,"University of California, San Diego",,2.0,,Could only enroll 4 subjects in nearly 2 years,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,OTHER,,,,,,,2023,0.0
NCT03111069,,2017-04-06,,,2018-07-18,2017-04-11,2017-04-12,ACTUAL,,,,,,,2018-07-18,2018-07-20,ACTUAL,2018-08,ESTIMATED,2018-08-31,2018-07,2018-07-31,2021-08,ESTIMATED,2021-08-31,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,,,Study of Doxorubicin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Intraoperative Brachytherapy for Unresectable or Refractory Pelvic and Abdominal Rhabdomyosarcoma and Undifferentiated Sarcomas in Children,A Phase I Study of Doxorubicin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Intraoperative Brachytherapy for Unresectable or Refractory Pelvic and Abdominal Rhabdomyosarcoma and Undifferentiated Sarcomas in Children,WITHDRAWN,,PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,PI withdrew study,f,,,,f,t,f,,,,,,,,,,,2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,OTHER,,,,,,,2021,0.0
NCT04399837,,2020-05-20,2023-11-21,,2023-11-21,2020-05-20,2020-05-22,ACTUAL,2023-11-21,2023-12-14,ACTUAL,,,,2023-11-21,2023-12-14,ACTUAL,2020-06-04,ACTUAL,2020-06-04,2023-11,2023-11-30,2022-11-23,ACTUAL,2022-11-23,2022-11-23,ACTUAL,2022-11-23,,INTERVENTIONAL,,Randomized Set: This patient set includes all randomized patients.,A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis,"Effisayil™ 2: Multi-center, Randomized, Parallel Group, Double Blind, Placebo Controlled, Phase IIb Dose-finding Study to Evaluate Efficacy and Safety of BI 655130 (Spesolimab) Compared to Placebo in Preventing Generalized Pustular Psoriasis (GPP) Flares in Patients With History of GPP.",COMPLETED,,PHASE2,123.0,ACTUAL,Boehringer Ingelheim,,4.0,,,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,INDUSTRY,,,,,,,2022,1.0
NCT02620007,,2015-11-30,,,2023-08-21,2015-12-01,2015-12-02,ESTIMATED,,,,,,,2023-08-21,2023-08-23,ACTUAL,2015-12,,2015-12-31,2019-02,2019-02-28,2022-06,ACTUAL,2022-06-30,2021-08,ACTUAL,2021-08-31,,INTERVENTIONAL,TEOREM,,Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn Disease,Multicenter Double Blind Randomized Clinical Trial Assessing the Benefit of Adherent Invasive E. Coli Eradication in Adult Ileal and Ileo-colonic Crohn Disease,TERMINATED,,PHASE2,24.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,insufficient recruitment,f,,,,t,,,,,,,,,,,,,2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,OTHER,,,,,,,2022,0.0
NCT04680676,,2020-11-13,,,2021-11-04,2020-12-17,2020-12-23,ACTUAL,,,,,,,2021-11-04,2021-11-08,ACTUAL,2022-05-02,ESTIMATED,2022-05-02,2021-11,2021-11-30,2023-09-25,ESTIMATED,2023-09-25,2023-06-26,ESTIMATED,2023-06-26,,INTERVENTIONAL,,,A Study to Test Different Doses of BI 730357 and Find Out Whether They Reduce Symptoms in People With Active Psoriatic Arthritis,"A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging, Proof-of-concept Trial of BI 730357 Given for 12 Weeks in Patients With Active Psoriatic Arthritis",WITHDRAWN,,PHASE2,0.0,ACTUAL,Boehringer Ingelheim,,4.0,,Program discontinued,f,,,,t,t,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-15 07:47:28.439643,2024-10-15 07:47:28.439643,INDUSTRY,,,,,,,2023,0.0
NCT05129423,,2021-11-05,,,2022-11-16,2021-11-10,2021-11-22,ACTUAL,,,,,,,2022-11-16,2022-11-18,ACTUAL,2022-07-31,ESTIMATED,2022-07-31,2022-11,2022-11-30,2024-08-31,ESTIMATED,2024-08-31,2024-07-31,ESTIMATED,2024-07-31,,INTERVENTIONAL,,,A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria,"A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot and Dose-Ranging Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Genentech, Inc.",,8.0,,Development of MTPS9579A was terminated for strategic/business reasons.,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,INDUSTRY,,,,,,,2024,0.0
NCT03476044,,2018-03-18,,,2020-10-15,2018-03-18,2018-03-23,ACTUAL,,,,,,,2020-10-15,2020-10-19,ACTUAL,2018-06-01,ACTUAL,2018-06-01,2020-10,2020-10-31,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,,Effect of Selenium on Succinylcholine-Induced POM,Effect of Selenium on Succinylcholine-Induced Postoperative Myalgia After Adult Sinuscopic Procedures,COMPLETED,,PHASE2/PHASE3,80.0,ACTUAL,Assiut University,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 05:46:10.498183,2024-10-16 05:46:10.498183,OTHER,,,,,,,2020,1.0
NCT02772679,,2016-05-10,,,2021-10-15,2016-05-11,2016-05-13,ESTIMATED,,,,,,,2021-10-15,2021-10-19,ACTUAL,2016-08,,2016-08-31,2021-10,2021-10-31,2021-08-27,ACTUAL,2021-08-27,2021-08-27,ACTUAL,2021-08-27,,INTERVENTIONAL,TILT,,T1DM Immunotherapy Using Polyclonal Tregs + IL-2,A Phase 1 Trial of CD4+CD127lo/-CD25+ Polyclonal Treg Adoptive Immunotherapy With Interleukin-2 for the Treatment of Type 1 Diabetes,COMPLETED,,PHASE1,16.0,ACTUAL,"University of California, San Francisco",,1.0,,,f,,,,t,t,,,,,,,,,,NO,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,OTHER,,,,,,,2021,1.0
NCT03371355,,2017-11-27,2020-12-22,2020-11-19,2021-01-28,2017-12-11,2017-12-13,ACTUAL,2021-01-28,2021-02-01,ACTUAL,2021-01-28,2021-02-01,ACTUAL,2021-01-28,2021-02-01,ACTUAL,2017-12-21,ACTUAL,2017-12-21,2020-12,2020-12-31,2020-02-24,ACTUAL,2020-02-24,2019-11-21,ACTUAL,2019-11-21,,INTERVENTIONAL,,Full Analysis Set (FAS) population included all participants who were randomized and received at least 1 dose of study drug.,"Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease","A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study of ISIS 703802 (AKCEA-ANGPTL3-LRx) Administered Subcutaneously to Subjects With Hypertriglyceridemia, Type 2 Diabetes Mellitus (T2DM), and Nonalcoholic Fatty Liver Disease (NAFLD)",COMPLETED,,PHASE2,105.0,ACTUAL,Akcea Therapeutics,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 05:46:10.498183,2024-10-16 05:46:10.498183,INDUSTRY,,,,,,,2020,1.0
NCT04968379,,2020-11-02,,,2023-01-05,2021-07-08,2021-07-20,ACTUAL,,,,,,,2023-01-05,2023-01-06,ACTUAL,2022-07-21,ACTUAL,2022-07-21,2023-01,2023-01-31,2024-12-12,ESTIMATED,2024-12-12,2024-10-08,ESTIMATED,2024-10-08,,INTERVENTIONAL,,,"Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia","An Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Ferric Carboxymaltose (FCM) in Infants (0-1 Year) With Iron Deficiency Anemia",WITHDRAWN,,PHASE2,0.0,ACTUAL,"American Regent, Inc.",,2.0,,Difficult to recruit and enroll patients for this study in a reasonable amount of time.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,INDUSTRY,,,,,,,2024,0.0
NCT05136833,,2021-11-10,,,2022-07-12,2021-11-23,2021-11-29,ACTUAL,,,,,,,2022-07-12,2022-07-13,ACTUAL,2021-12-01,ACTUAL,2021-12-01,2022-07,2022-07-31,2022-12-31,ESTIMATED,2022-12-31,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,CONSTAN,,Evaluation of Efficacy and Safety of the Concomitant of RUTI® Immunotherapy With the Standard Treatment in TB Patients,A Phase IIb Study to Explore the Efficacy and Safety of the Concomitant Administration of RUTI® Immunotherapy With the Standard Treatment in Patients With TB,WITHDRAWN,,PHASE2,0.0,ACTUAL,Archivel Farma S.L.,,2.0,,Covid-19 pandemia,f,,,,,f,f,,,,,,,,,,,2024-10-16 05:46:10.498183,2024-10-16 05:46:10.498183,INDUSTRY,,,,,,,2022,0.0
NCT04953052,,2021-06-29,,,2022-07-26,2021-07-05,2021-07-07,ACTUAL,,,,,,,2022-07-26,2022-07-28,ACTUAL,2021-10-14,ESTIMATED,2021-10-14,2022-07,2022-07-31,2022-11-30,ESTIMATED,2022-11-30,2022-08-31,ESTIMATED,2022-08-31,,INTERVENTIONAL,IMPRESS COVID,,A Randomized Study to Investigate the Effect of Intravenous Imatinib on the Amount of Oxygen in the Lungs and Blood of Adults With COVID-19 Needing Mechanical Ventilation and Supportive Care.,"A Randomized, Double-blind, Multicentre 2-arm, Parallel-group, Placebo-controlled Study to Investigate the Efficacy and Safety of Intravenous Imatinib Mesylate in Reducing the Severity of Hypoxemic Respiratory Failure in Patients With Critical COVID-19 Receiving Standard of Care.",WITHDRAWN,,PHASE2,0.0,ACTUAL,Exvastat Ltd.,,2.0,,Number of moderate to severe ARDS patients hospitalised due to COVID19 diminishingly small. Not expected to recruit required minimum number of patients.,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,INDUSTRY,,,,,,,2022,0.0
NCT03469050,,2018-03-06,,,2021-10-13,2018-03-12,2018-03-19,ACTUAL,,,,,,,2021-10-13,2021-10-20,ACTUAL,2018-07-02,ACTUAL,2018-07-02,2021-07,2021-07-31,2020-12-22,ACTUAL,2020-12-22,2020-12-22,ACTUAL,2020-12-22,,INTERVENTIONAL,ROAD,,Rifaximin Delayed Release for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications.,"Rifaximin Delayed Release (400 mg Tablet) for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications. A Phase II, Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial",TERMINATED,,PHASE2/PHASE3,193.0,ACTUAL,Alfasigma S.p.A.,,3.0,,Sponsor's decision,f,,,,t,f,f,,,,,,,,,,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,INDUSTRY,,,,,,,2020,0.0
NCT03830866,,2018-12-04,2023-01-13,,2024-06-28,2019-02-04,2019-02-05,ACTUAL,2023-03-02,2023-03-06,ACTUAL,,,,2024-06-28,2024-07-26,ACTUAL,2019-02-15,ACTUAL,2019-02-15,2024-06,2024-06-30,2023-07-03,ACTUAL,2023-07-03,2022-01-20,ACTUAL,2022-01-20,,INTERVENTIONAL,CALLA,,Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA),"A Phase III, Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With and Following Chemoradiotherapy Compared to Chemoradiotherapy Alone for Treatment in Women With Locally Advanced Cervical Cancer",COMPLETED,,PHASE3,770.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,INDUSTRY,,,,,,,2023,1.0
NCT02853344,,2016-07-29,2022-02-01,,2023-03-17,2016-07-29,2016-08-02,ESTIMATED,2022-04-20,2022-05-11,ACTUAL,,,,2023-03-17,2023-04-11,ACTUAL,2016-09-30,ACTUAL,2016-09-30,2023-03,2023-03-31,2022-04-01,ACTUAL,2022-04-01,2021-02-05,ACTUAL,2021-02-05,,INTERVENTIONAL,,,Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427),"A Phase II Single-arm, Open-label Monotherapy Clinical Trial of Pembrolizumab (MK-3475) in Locally Advanced/Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-427)",COMPLETED,,PHASE2,275.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,INDUSTRY,,,,,,,2022,1.0
NCT04327310,,2020-03-24,,,2023-09-19,2020-03-30,2020-03-31,ACTUAL,,,,,,,2023-09-19,2023-09-21,ACTUAL,2023-03,ESTIMATED,2023-03-31,2023-01,2023-01-31,2024-03,ESTIMATED,2024-03-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Clinical Study of Meplazumab to Treat With Malaria,"A Phase 1, 3 Part, Randomized, Placebo Controlled, Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Single Intravenous Doses of Meplazumab and to Assess Its Antimalarial Activity Against Plasmodium Falciparum in a Malaria Challenge Model in Healthy Subjects",WITHDRAWN,,PHASE1,0.0,ACTUAL,Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd,,2.0,,The same drug has completed the phase I and II clinical trials for COVID-19,f,,,,,t,f,,,,,,,,,,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,INDUSTRY,,,,,,,2024,0.0
NCT03181893,,2017-06-05,2023-05-26,,2023-09-08,2017-06-07,2017-06-09,ACTUAL,2023-09-08,2023-09-14,ACTUAL,,,,2023-09-08,2023-09-14,ACTUAL,2018-01-23,ACTUAL,2018-01-23,2023-09,2023-09-30,2022-11-28,ACTUAL,2022-11-28,2022-05-27,ACTUAL,2022-05-27,,INTERVENTIONAL,,The safety analysis population included all participants who had received at least 1 dose of study drug or placebo.,A Study In Adults With Moderate To Severe Dermatomyositis,"A PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS",COMPLETED,,PHASE2,75.0,ACTUAL,Pfizer,,3.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,INDUSTRY,,,,,,,2022,1.0
NCT04534803,,2020-08-21,,,2021-06-23,2020-08-29,2020-09-01,ACTUAL,,,,,,,2021-06-23,2021-06-28,ACTUAL,2021-09,ESTIMATED,2021-09-30,2021-06,2021-06-30,2022-07,ESTIMATED,2022-07-31,2022-05,ESTIMATED,2022-05-31,,INTERVENTIONAL,,,BCG Against Covid-19 for Prevention and Amelioration of Severity Trial (BAC to the PAST),Bacillus Calmette-Guerin Against Covid-19 for Prevention and Amelioration of Severity Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,Harvard Medical School (HMS and HSDM),,2.0,,At this time it has been decided by the study team the the study will no longer take place in the United States.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,OTHER,,,,,,,2022,0.0
NCT04319731,,2020-03-22,,,2023-04-20,2020-03-22,2020-03-24,ACTUAL,,,,,,,2023-04-20,2023-04-24,ACTUAL,2020-03-20,ACTUAL,2020-03-20,2020-04,2020-04-30,2020-06-09,ACTUAL,2020-06-09,2020-06-09,ACTUAL,2020-06-09,,INTERVENTIONAL,,,A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure,A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure,COMPLETED,,EARLY_PHASE1,10.0,ACTUAL,University of Utah,,1.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,OTHER,,,,,,,2020,1.0
NCT03630367,,2018-08-04,,,2021-04-22,2018-08-10,2018-08-14,ACTUAL,,,,,,,2021-04-22,2021-04-23,ACTUAL,2018-10-03,ACTUAL,2018-10-03,2021-04,2021-04-30,2020-10,ESTIMATED,2020-10-31,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,Effects of L-Carnitine Supplementation on Respiratory Distress Syndrome,Effects of Adding L-Carnitine With Dexamethasone on Respiratory Distress Syndrome Development in Preterm Infants,WITHDRAWN,,PHASE4,0.0,ACTUAL,Assiut University,,2.0,,Unavailability of the medication,f,,,,f,f,f,,,,,,,,,,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,OTHER,,,,,,,2020,0.0
NCT05121402,,2021-11-05,,,2022-05-09,2021-11-14,2021-11-16,ACTUAL,,,,,,,2022-05-09,2022-05-13,ACTUAL,2022-12-30,ESTIMATED,2022-12-30,2022-05,2022-05-31,2023-12-30,ESTIMATED,2023-12-30,2023-07-01,ESTIMATED,2023-07-01,,INTERVENTIONAL,,,Safety and Efficacy Study of TLL018 in the Treatment of Ulcerative Colitis,"A Phase 2 Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of TLL018 for Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Hangzhou Highlightll Pharmaceutical Co., Ltd",,4.0,,Decisions made by senior management of the company,f,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-16 05:46:10.498183,2024-10-16 05:46:10.498183,INDUSTRY,,,,,,,2023,0.0
NCT03686514,,2018-09-25,2022-03-22,2022-01-24,2022-06-16,2018-09-25,2018-09-27,ACTUAL,2022-06-16,2022-07-13,ACTUAL,2022-06-16,2022-07-13,ACTUAL,2022-06-16,2022-07-13,ACTUAL,2018-10-22,ACTUAL,2018-10-22,2022-06,2022-06-30,2020-06-20,ACTUAL,2020-06-20,2020-06-20,ACTUAL,2020-06-20,,INTERVENTIONAL,FLU2,,"The Impact of Imprinting and Repeated Influenza Vaccination on Adaptive Immunity, Transcriptomics, and Metabolomics","The Impact of Imprinting and Repeated Influenza Vaccination on Adaptive Immunity, Transcriptomics, and Metabolomics",TERMINATED,,PHASE4,39.0,ACTUAL,Emory University,"Due to the COVID-19 pandemic, this study was terminated prior to beginning year 3 of the study.",2.0,,The study closed prior to completing year 3 of the study due to the COVID-19 pandemic.,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,OTHER,,,,,,,2020,0.0
NCT03960554,,2019-05-21,2024-07-01,,2024-07-23,2019-05-21,2019-05-23,ACTUAL,2024-07-23,2024-07-25,ACTUAL,,,,2024-07-23,2024-07-25,ACTUAL,2020-01-16,ACTUAL,2020-01-16,2024-07,2024-07-31,2021-12-02,ACTUAL,2021-12-02,2021-12-02,ACTUAL,2021-12-02,,INTERVENTIONAL,ProliaKTx,,The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients,"The Effects of 12-months of Denosumab on Bone Density, Quality and Strength in Prevalent Kidney Transplant Recipients",TERMINATED,,PHASE2,8.0,ACTUAL,Columbia University,"Due to the COVID-19 pandemic, this study was terminated early and no Outcome Measure data was collected from participants.",2.0,,Study lost funding,,,,,t,t,f,,,,,,,,,,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,OTHER,,,,,,,2021,0.0
NCT03956056,,2019-05-15,2023-05-01,,2024-06-20,2019-05-15,2019-05-20,ACTUAL,2023-05-26,2023-05-31,ACTUAL,,,,2024-06-20,2024-07-17,ACTUAL,2020-02-13,ACTUAL,2020-02-13,2024-06,2024-06-30,2023-07-06,ACTUAL,2023-07-06,2022-07-21,ACTUAL,2022-07-21,,INTERVENTIONAL,,,Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy,A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy,TERMINATED,,PHASE1,12.0,ACTUAL,Washington University School of Medicine,,1.0,,Insufficient funding/staff,,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,OTHER,,,,,,,2023,0.0
NCT03131453,,2017-04-05,2021-03-25,,2021-08-04,2017-04-24,2017-04-27,ACTUAL,2021-08-04,2021-08-05,ACTUAL,,,,2021-08-04,2021-08-05,ACTUAL,2017-08-03,ACTUAL,2017-08-03,2021-08,2021-08-31,2020-03-26,ACTUAL,2020-03-26,2020-03-26,ACTUAL,2020-03-26,,INTERVENTIONAL,GS2,One patient was misrandomized and not included in the CNP520 50mg arm,A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease,"A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (AD).",TERMINATED,,PHASE2/PHASE3,1145.0,ACTUAL,Novartis,The study was terminated due to safety issues.,3.0,,The study was terminated due to safety issues.,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,INDUSTRY,,,,,,,2020,0.0
NCT04824365,,2021-03-26,2022-08-25,,2022-10-05,2021-03-29,2021-04-01,ACTUAL,2022-08-25,2022-09-26,ACTUAL,,,,2022-10-05,2022-11-02,ACTUAL,2021-04-12,ACTUAL,2021-04-12,2022-10,2022-10-31,2022-08-12,ACTUAL,2022-08-12,2022-08-12,ACTUAL,2022-08-12,,INTERVENTIONAL,,,Sodium Pyruvate Nasal Spray Treatment of COVID-19 Infection,"Two Week Sub-chronic Double-blinded Placebo Controlled Trial Designed to Determine if Sodium Pyruvate Nasal Spray Will Reduce the Symptoms, Duration and Replication of COVID-19 Infection",COMPLETED,,PHASE2/PHASE3,30.0,ACTUAL,"Cellular Sciences, inc.","The number of patients enrolled in this trial was small, thus decreasing the power of the statistical analysis.",2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,INDUSTRY,,,,,,,2022,1.0
NCT05692908,,2023-01-11,,,2023-04-26,2023-01-11,2023-01-20,ACTUAL,,,,,,,2023-04-26,2023-04-28,ACTUAL,2023-09,ESTIMATED,2023-09-30,2023-04,2023-04-30,2024-11,ESTIMATED,2024-11-30,2024-09,ESTIMATED,2024-09-30,,INTERVENTIONAL,,,An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With AL Amyloidosis,"An Open-Label, Dose-Escalation Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Systemic AL Amyloidosis",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,1.0,,Sorrento Therapeutics filed for chapter 11 bankruptcy.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,INDUSTRY,,,,,,,2024,0.0
NCT05375760,,2022-05-16,,,2023-11-03,2022-05-16,2022-05-17,ACTUAL,,,,,,,2023-11-03,2023-11-07,ACTUAL,2022-06-09,ACTUAL,2022-06-09,2023-11,2023-11-30,2023-10-04,ACTUAL,2023-10-04,2023-10-04,ACTUAL,2023-10-04,,INTERVENTIONAL,ENDURE,,"A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19","A Phase II Randomized, Open-label, Multicenter, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, a Combination Product of Two Monoclonal Antibodies (Tixagevimab and Cilgavimab), for Pre-exposure Prophylaxis of COVID-19",TERMINATED,,PHASE2,251.0,ACTUAL,AstraZeneca,,2.0,,"Sponsor terminated after review of FDA's request to halt further dosing (30Mar2023) given that AZD7442 is not active against \>99% of the currently circulating SARS-CoV-2 variants in the USA, the benefit risk assessment may not be favorable",f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 05:46:10.498183,2024-10-16 05:46:10.498183,INDUSTRY,,,,,,,2023,0.0
NCT04732169,,2021-01-13,,,2021-07-13,2021-01-26,2021-02-01,ACTUAL,,,,,,,2021-07-13,2021-07-19,ACTUAL,2021-07-01,ACTUAL,2021-07-01,2021-07,2021-07-31,2021-07-09,ACTUAL,2021-07-09,2021-07-09,ACTUAL,2021-07-09,,INTERVENTIONAL,CBD,,Cannabidiol for Treatment Resistant Depression,Cannabidiol for Treatment Resistant Depression,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Alabama at Birmingham,,2.0,,"Investigator decided not to do study, due to insufficient funding.",f,,,,f,t,f,,,f,,,3 years,Will share with public,,YES,"Plan to share protocol, consent, SAP,and CRS. Do not plan to share IPD,",2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,OTHER,,,,,,,2021,0.0
NCT04171284,,2019-11-12,,,2024-02-07,2019-11-18,2019-11-20,ACTUAL,,,,,,,2024-02-07,2024-02-09,ACTUAL,2019-10-22,ACTUAL,2019-10-22,2024-02,2024-02-29,2023-02-23,ACTUAL,2023-02-23,2023-02-23,ACTUAL,2023-02-23,,INTERVENTIONAL,,,SCT-I10A or Placebo Plus Docetaxel With Previously Treated Squamous Cell Non-small Cell Lung Cancer,A Multicenter Randomized Double-blinded Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of SCT-I10A or Placebo Plus Docetaxel in Treating Advanced Squamous Non-small Cell Lung Cancer,TERMINATED,,PHASE3,188.0,ACTUAL,Sinocelltech Ltd.,,4.0,,"Strategy adjustments, independent of the safety and efficacy of the trial medication",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,INDUSTRY,,,,,,,2023,0.0
NCT04426201,,2020-06-09,,,2024-04-10,2020-06-09,2020-06-11,ACTUAL,,,,,,,2024-04-10,2024-04-11,ACTUAL,2020-12-20,ACTUAL,2020-12-20,2024-04,2024-04-30,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,ILIAD-7-US-O,,InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O ),"A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection. US Oncology Cohort",TERMINATED,,PHASE2,10.0,ACTUAL,Revimmune,,2.0,,POOR ACCRUAL,f,,,,t,t,f,,,,,,,,,NO,Publication,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,INDUSTRY,,,,,,,2022,0.0
NCT02949830,,2016-10-28,2022-11-05,,2024-03-11,2016-10-28,2016-10-31,ESTIMATED,2024-03-11,2024-03-12,ACTUAL,,,,2024-03-11,2024-03-12,ACTUAL,2016-10,ACTUAL,2016-10-31,2024-03,2024-03-31,2021-11-05,ACTUAL,2021-11-05,2021-11-05,ACTUAL,2021-11-05,,INTERVENTIONAL,,Safety Analysis Set (SAS): All patients who received any amount of study drug.,A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP),"A Multicenter, Open-label Extension Study to Evaluate the Long-term Safety and Clinical Activity of Subcutaneously Administered ALN-AS1 in Patients With Acute Intermittent Porphyria Who Have Completed a Previous Clinical Study With ALN-AS1",COMPLETED,,PHASE1/PHASE2,16.0,ACTUAL,Alnylam Pharmaceuticals,,1.0,,,f,,,,f,,,,,,,,,,,UNDECIDED,,2024-10-16 05:46:10.498183,2024-10-16 05:46:10.498183,INDUSTRY,,,,,,,2021,1.0
NCT03480867,,2018-03-21,,,2019-08-12,2018-03-21,2018-03-29,ACTUAL,,,,,,,2019-08-12,2019-08-14,ACTUAL,2017-03,ESTIMATED,2017-03-31,2019-08,2019-08-31,2023-11,ESTIMATED,2023-11-30,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,PARADIGMA,,Pre-operative RT and TMZ in Patients With Newly Diagnosed GBM Diagnosed Glioblastoma. A Phase I Study. (PARADIGMA),Pre-operative Radiation Therapy (RT) and Temozolomide (TMZ) in Patients With Newly Diagnosed Glioblastoma. A Phase I Study. (PARADIGMA),WITHDRAWN,,PHASE1,0.0,ACTUAL,McGill University Health Centre/Research Institute of the McGill University Health Centre,,1.0,,competing study was opened by the surgeon after this trial was opened,f,,,,t,f,f,,,f,,,,,,UNDECIDED,"Upon official request approved by the Research Ethics Board (REB), some data may be shared depending on what needs to be shared.",2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,OTHER,,,,,,,2023,0.0
NCT04727541,,2021-01-25,,,2022-05-17,2021-01-26,2021-01-27,ACTUAL,,,,,,,2022-05-17,2022-05-23,ACTUAL,2021-07-08,ACTUAL,2021-07-08,2022-05,2022-05-31,2022-01-05,ACTUAL,2022-01-05,2021-10-04,ACTUAL,2021-10-04,,INTERVENTIONAL,NEOBIL,,Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer,Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer,TERMINATED,,PHASE2,3.0,ACTUAL,AIO-Studien-gGmbH,,1.0,,"Based on results of another phase II study with bintrafusp alfa in combination with gemcitabine plus cisplatin, that was discontinued as it was unlikely to meet the primary endpoint of OS, the recruitment for this study was stopped prematurely.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 05:46:10.498183,2024-10-16 05:46:10.498183,OTHER,,,,,,,2022,0.0
NCT02109081,,2014-04-05,,,2021-12-06,2014-04-07,2014-04-09,ESTIMATED,,,,,,,2021-12-06,2021-12-21,ACTUAL,2014-04,ACTUAL,2014-04-30,2019-09,2019-09-30,2021-02,ACTUAL,2021-02-28,2021-02,ACTUAL,2021-02-28,,INTERVENTIONAL,,,Dexamethasone and Postoperative Delirium,Dexamethasone and Postoperative Delirium,TERMINATED,,PHASE4,200.0,ACTUAL,NorthShore University HealthSystem,,2.0,,Investigator left institution,f,,,,f,,,,,,,,,,,,,2024-10-16 05:46:10.498183,2024-10-16 05:46:10.498183,OTHER,,,,,,,2021,0.0
NCT04088448,,2019-09-11,,,2020-06-13,2019-09-11,2019-09-12,ACTUAL,,,,,,,2020-06-13,2020-06-16,ACTUAL,2017-01-01,ACTUAL,2017-01-01,2020-06,2020-06-30,2020-06-01,ACTUAL,2020-06-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,,,The Antidiabetic Metformin as a Novel Adjunct to Antidepressants in Major Depressive Disorder Patients,"The Antidiabetic Metformin as a Novel Adjunct to Antidepressants in Major Depressive Disorder Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial",COMPLETED,,PHASE1/PHASE2,80.0,ACTUAL,Sadat City University,,2.0,,,f,,,,t,f,f,,,,,,,,https://link.springer.com/article/10.1007/s13311-020-00878-7,YES,,2024-10-16 05:46:10.498183,2024-10-16 05:46:10.498183,OTHER,,,,,,,2020,1.0
NCT04684654,,2020-12-22,,,2023-08-22,2020-12-22,2020-12-24,ACTUAL,,,,,,,2023-08-22,2023-08-23,ACTUAL,2021-02-16,ACTUAL,2021-02-16,2023-08,2023-08-31,2023-07-25,ACTUAL,2023-07-25,2023-07-25,ACTUAL,2023-07-25,,INTERVENTIONAL,,,BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome,"A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Dose Study on the Safety, Pharmacokinetics, and Exploratory Pharmacodynamics of Subcutaneous and Intravenous BMS-986325 Administration in Healthy Participants and Participants With Primary Sjögren's Syndrome",TERMINATED,,PHASE1,118.0,ACTUAL,Bristol-Myers Squibb,,6.0,,Insufficient enrollment,f,,,,f,t,f,,,,,,,,,,,2024-10-16 05:46:10.498183,2024-10-16 05:46:10.498183,INDUSTRY,,,,,,,2023,0.0
NCT03527576,,2018-05-04,,,2022-07-19,2018-05-16,2018-05-17,ACTUAL,,,,,,,2022-07-19,2022-07-20,ACTUAL,2018-05-01,ACTUAL,2018-05-01,2022-07,2022-07-31,2022-04-01,ACTUAL,2022-04-01,2021-11-01,ACTUAL,2021-11-01,,INTERVENTIONAL,,,Block Duration After Spinal Block and iv Dexamethasone.,Block Duration After Spinal Block and iv Dexamethasone: a Randomized Controlled Double-blinded Trial,COMPLETED,,PHASE4,50.0,ACTUAL,Centre Hospitalier Universitaire Vaudois,,2.0,,,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-16 05:46:10.498183,2024-10-16 05:46:10.498183,OTHER,,,,,,,2022,0.0
NCT04576312,,2020-09-28,,,2021-08-20,2020-10-05,2020-10-06,ACTUAL,,,,,,,2021-08-20,2021-08-26,ACTUAL,2020-06-29,ACTUAL,2020-06-29,2021-08,2021-08-31,2020-12-04,ACTUAL,2020-12-04,2020-12-04,ACTUAL,2020-12-04,,INTERVENTIONAL,,,Safety of Ascending Doses of Niclosamide (UNI911 INHALATION) in Healthy Volunteers,"Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults With COVID-19",COMPLETED,,PHASE1,64.0,ACTUAL,UNION therapeutics,,8.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 05:46:10.498183,2024-10-16 05:46:10.498183,INDUSTRY,,,,,,,2020,1.0
NCT05128773,,2021-11-10,2023-03-31,,2023-06-15,2021-11-10,2021-11-22,ACTUAL,2023-06-15,2023-06-22,ACTUAL,,,,2023-06-15,2023-06-22,ACTUAL,2022-02-17,ACTUAL,2022-02-17,2023-06,2023-06-30,2022-10-13,ACTUAL,2022-10-13,2022-10-13,ACTUAL,2022-10-13,,INTERVENTIONAL,AMEERA-6,Analysis was performed on the randomized population.,"Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity","A Randomized, Multicenter, Double-blind, Phase 3 Study of Amcenestrant (SAR439859) Versus Tamoxifen for the Treatment of Patients With Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative or Positive, Stage IIB-III Breast Cancer Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity",TERMINATED,,PHASE3,3.0,ACTUAL,Sanofi,"Due to premature discontinuation and closure of study decided by the Sponsor, only safety data were summarized and reported, and no efficacy data was collected.",2.0,,"Sponsor decision to prematurely stop the study, not linked to any safety concern",f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,INDUSTRY,,,,,,,2022,0.0
NCT03977454,,2019-06-04,2022-08-26,2022-06-15,2022-08-26,2019-06-05,2019-06-06,ACTUAL,2022-08-26,2022-09-23,ACTUAL,2022-06-15,2022-06-21,ACTUAL,2022-08-26,2022-09-23,ACTUAL,2019-11-11,ACTUAL,2019-11-11,2022-08,2022-08-31,2021-06-19,ACTUAL,2021-06-19,2021-06-19,ACTUAL,2021-06-19,,INTERVENTIONAL,,Patients deemed immediate postoperative revision were not included in any of the analyses.,Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty,Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty: a Single Center Randomized Controlled Trail (RCT) Study,COMPLETED,,PHASE2,192.0,ACTUAL,Yale University,,2.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,OTHER,,,,,,,2021,1.0
NCT05324618,,2022-01-16,,,2023-07-21,2022-04-05,2022-04-12,ACTUAL,,,,,,,2023-07-21,2023-07-24,ACTUAL,2022-05-15,ACTUAL,2022-05-15,2022-01,2022-01-31,2023-04-30,ACTUAL,2023-04-30,2022-11-20,ACTUAL,2022-11-20,,INTERVENTIONAL,,,Tacrolimus Versus Hydrocortisone in Atopic Dermatitis,A Comparative Clinical Trial to Evaluate the Efficacy and Safety of Tacrolimus Versus Hydrocortisone in Treatment of Children With Atopic Dermatitis,COMPLETED,,PHASE4,200.0,ACTUAL,Ain Shams University,,2.0,,,f,,,,,f,f,,,f,,,,,,,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,OTHER,,,,,,,2023,1.0
NCT02808871,,2016-03-20,2022-04-13,,2022-07-20,2016-06-17,2016-06-22,ESTIMATED,2022-07-20,2022-08-16,ACTUAL,,,,2022-07-20,2022-08-16,ACTUAL,2017-04-07,ACTUAL,2017-04-07,2022-07,2022-07-31,2021-04-07,ACTUAL,2021-04-07,2021-04-07,ACTUAL,2021-04-07,,INTERVENTIONAL,,,Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1),"Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients With Rheumatoid Arthritis Interstitial Lung Disease (TRAIL1)",COMPLETED,,PHASE2,123.0,ACTUAL,Brigham and Women's Hospital,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,OTHER,,,,,,,2021,0.0
NCT05477186,,2022-07-27,,,2024-02-29,2022-07-27,2022-07-28,ACTUAL,,,,,,,2024-02-29,2024-03-01,ACTUAL,2022-08-12,ACTUAL,2022-08-12,2024-02,2024-02-29,2023-08-18,ACTUAL,2023-08-18,2023-08-18,ACTUAL,2023-08-18,,INTERVENTIONAL,,,Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old,"A Phase 1, Open-label, Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old",COMPLETED,,PHASE1,180.0,ACTUAL,GlaxoSmithKline,,7.0,,,f,,,,,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,INDUSTRY,,,,,,,2023,1.0
NCT02857218,,2016-08-02,,,2021-09-08,2016-08-02,2016-08-05,ESTIMATED,,,,,,,2021-09-08,2021-09-16,ACTUAL,2018-04-27,ACTUAL,2018-04-27,2021-09,2021-09-30,2021-08-19,ACTUAL,2021-08-19,2021-08-19,ACTUAL,2021-08-19,,INTERVENTIONAL,,,Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Stage IIB-IIIC Esophageal Cancer,A Pilot Study Using a Novel Imaging of Lymph Nodes in Patients With Locally Advanced Esophageal Cancer Using Ferumoxytol Enhanced MRI,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,OHSU Knight Cancer Institute,,1.0,,Inadequate enrollment,f,,,,t,t,f,,,,,,,,,,,2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,OTHER,,,,,,,2021,0.0
NCT04003610,,2019-06-28,2022-03-17,,2022-05-24,2019-06-28,2019-07-01,ACTUAL,2022-05-04,2022-05-25,ACTUAL,,,,2022-05-24,2022-05-26,ACTUAL,2020-05-14,ACTUAL,2020-05-14,2022-05,2022-05-31,2021-04-18,ACTUAL,2021-04-18,2021-04-18,ACTUAL,2021-04-18,,INTERVENTIONAL,,No participants were enrolled in the pemigatinib 13.5 mg treatment arm.,Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205),"A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Plus Pembrolizumab Versus Pemigatinib Alone Versus Standard of Care as First-Line Treatment for Metastatic or Unresectable Urothelial Carcinoma in Cisplatin-Ineligible Participants Whose Tumors Express FGFR3 Mutation or Rearrangement (FIGHT-205)",TERMINATED,,PHASE2,7.0,ACTUAL,Incyte Corporation,"The Sponsor made a decision unrelated to safety to halt study enrollment. Due to early termination of the study with only 7 participants, no analysis of efficacy endpoints was done.",3.0,,The reason this study was terminated was due to a business decision. There were no safety concerns that contributed to this decision.,f,,,,t,t,f,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency,2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,INDUSTRY,,,,,,,2021,0.0
NCT04214652,,2019-12-30,2024-01-09,2022-03-15,2024-01-31,2019-12-30,2020-01-02,ACTUAL,2024-01-31,2024-02-01,ACTUAL,2022-03-15,2022-03-16,ACTUAL,2024-01-31,2024-02-01,ACTUAL,2020-01-27,ACTUAL,2020-01-27,2024-01,2024-01-31,2021-03-18,ACTUAL,2021-03-18,2021-03-18,ACTUAL,2021-03-18,,INTERVENTIONAL,,,Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris,"A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris",COMPLETED,,PHASE3,180.0,ACTUAL,"Bausch Health Americas, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,INDUSTRY,,,,,,,2021,1.0
NCT03632642,,2018-07-22,,,2022-11-10,2018-08-12,2018-08-15,ACTUAL,,,,,,,2022-11-10,2022-11-16,ACTUAL,2019-07-01,ESTIMATED,2019-07-01,2018-08,2018-08-31,2020-07,ESTIMATED,2020-07-31,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,PANFLUTE,,Penicillin Against Flucloxacillin Treatment Evaluation,Pilot Randomised Controlled Trial of Penicillin Versus Flucloxacillin for Definitive Treatment of Invasive Penicillin Susceptible Staphylococcus Aureus,WITHDRAWN,,PHASE4,0.0,ACTUAL,The University of Queensland,,2.0,,Study never commenced,f,,,,f,f,f,,,f,,,,,,UNDECIDED,"As this study is a feasibility pilot study of a planned definitive RCT, it is likely that IPD will be made available to future potential collaborators on a definitive study in order to determine the feasibility, calculate an appropriate sample size and determine if any changes are required to the study protocol and SAP in particular.",2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,OTHER,,,,,,,2020,0.0
NCT02684487,,2016-02-09,,,2021-04-30,2016-02-12,2016-02-18,ESTIMATED,,,,,,,2021-04-30,2021-05-05,ACTUAL,2017-12,ESTIMATED,2017-12-31,2021-04,2021-04-30,2022-12,ESTIMATED,2022-12-31,2022-07,ESTIMATED,2022-07-31,,INTERVENTIONAL,ViDISS,,Vitamin D Status in Patients With Severe Sepsis,Vitamin D Status in Patients With Severe Sepsis: A Randomized Clinical Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,Massachusetts General Hospital,,2.0,,"PI left institution. Protocol not submitted to IRB, contract not executed, and study was not done.",f,,,,t,t,f,,,t,,,,,,YES,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,OTHER,,,,,,,2022,0.0
NCT05442775,,2022-06-16,2024-06-10,,2024-07-23,2022-06-30,2022-07-05,ACTUAL,2024-07-23,2024-08-13,ACTUAL,,,,2024-07-23,2024-08-13,ACTUAL,2022-08-04,ACTUAL,2022-08-04,2024-07,2024-07-31,2023-06-07,ACTUAL,2023-06-07,2023-06-07,ACTUAL,2023-06-07,,INTERVENTIONAL,,Full Analysis Set,"A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)","A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)",TERMINATED,,PHASE3,71.0,ACTUAL,Cytokinetics,"Based on interim analysis results of the Phase 3 parent trial CY 5031 which met the criteria for futility in participants with ALS, CY 5032 was prematurely terminated on 31 March 2023.",1.0,,The DMC recommended the trial be discontinued due to futility following a planned second interim analysis of the parent trial (CY 5031).,f,,,,f,t,f,,,,,,,,,,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,INDUSTRY,,,,,,,2023,0.0
NCT05082831,,2021-06-08,,,2023-01-17,2021-10-05,2021-10-19,ACTUAL,,,,,,,2023-01-17,2023-01-19,ACTUAL,2021-11-15,ACTUAL,2021-11-15,2023-01,2023-01-31,2023-01-16,ACTUAL,2023-01-16,2022-12-16,ACTUAL,2022-12-16,,INTERVENTIONAL,hECM;HST003,,Human ECM Implanted Within Microfracture Interstices & the Cartilage Defect in the Knee to Regenerate Hyaline Cartilage,"A Prospective, Multicenter, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of a Human Extracellular Matrix Implanted in the Bone Interstices & the Cartilage Defect Following Arthroscopic Microfracture Surgery in the Knee,in Comparison to Microfracture Surgery Alone",TERMINATED,,PHASE1,1.0,ACTUAL,Histogen,,2.0,,Difficulty in enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,INDUSTRY,,,,,,,2023,0.0
NCT03248843,,2017-08-07,,,2022-02-07,2017-08-11,2017-08-14,ACTUAL,,,,,,,2022-02-07,2022-02-08,ACTUAL,2017-09-15,ACTUAL,2017-09-15,2022-02,2022-02-28,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,,A Study of PD-L1 Antibody KN035 in Japanese Subjects With Locally Advanced or Metastatic Solid Tumors,"A Phase I, Open Label, Dose Escalation Study of The Safety and Pharmacokinetics of Anti-PD-L1 Monoclonal Antibody KN035 Administered in Subcutaneous Injection as A Single Agent to Japanese Subjects With Locally Advanced or Metastatic Solid Tumors",COMPLETED,,PHASE1,35.0,ACTUAL,3D Medicines,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 07:52:29.944768,2024-10-15 07:52:29.944768,INDUSTRY,,,,,,,2020,1.0
NCT04152382,,2019-11-04,,,2022-02-28,2019-11-04,2019-11-05,ACTUAL,,,,,,,2022-02-28,2022-03-15,ACTUAL,2019-11-20,ACTUAL,2019-11-20,2022-02,2022-02-28,2022-02-09,ACTUAL,2022-02-09,2022-02-09,ACTUAL,2022-02-09,,INTERVENTIONAL,,,A Safety Study of LY3462817 and LY3509754 in Participants With Psoriasis,"A Multiple-Dose, Randomized, Placebo-Controlled, Study of LY3462817 or LY3509754 in Patients With Psoriasis",TERMINATED,,PHASE1,30.0,ACTUAL,Eli Lilly and Company,,6.0,,Terminated due to liver findings,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,INDUSTRY,,,,,,,2022,0.0
NCT02180672,,2014-07-01,2020-12-01,,2021-11-02,2014-07-02,2014-07-03,ESTIMATED,2021-02-18,2021-03-10,ACTUAL,,,,2021-11-02,2021-11-10,ACTUAL,2014-09,,2014-09-30,2021-11,2021-11-30,2021-10-30,ACTUAL,2021-10-30,2019-12-30,ACTUAL,2019-12-30,,INTERVENTIONAL,SPARK,,Steroids for Pediatric Apnea Research in Kids,Utility of Nasal Steroids for Treatment of Childhood Obstructive Sleep Apnea,COMPLETED,,PHASE3,211.0,ACTUAL,Children's Hospital of Philadelphia,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2021,0.0
NCT05413330,,2022-06-07,,,2023-04-24,2022-06-07,2022-06-10,ACTUAL,,,,,,,2023-04-24,2023-04-26,ACTUAL,2020-09-12,ACTUAL,2020-09-12,2023-04,2023-04-30,2022-03-29,ACTUAL,2022-03-29,2022-01-05,ACTUAL,2022-01-05,,INTERVENTIONAL,,,Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes.,Combined Phacoemulsification Surgery and Intravitreal Triamcinolone Injection Versus Stand-alone Surgery in Patients With Type 2 Diabetes: A Randomized Controlled Trial,COMPLETED,,PHASE2/PHASE3,73.0,ACTUAL,Damascus University,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,OTHER,,,,,,,2022,1.0
NCT04704843,,2021-01-08,,,2022-01-20,2021-01-08,2021-01-12,ACTUAL,,,,,,,2022-01-20,2022-02-03,ACTUAL,2021-06-17,ACTUAL,2021-06-17,2022-01,2022-01-31,2021-09-13,ACTUAL,2021-09-13,2021-09-13,ACTUAL,2021-09-13,,INTERVENTIONAL,,,A Study of Guselkumab in Adult Participants With Celiac Disease,"A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Response of Guselkumab in Adult Participants With Celiac Disease",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,Study terminated. Sponsor decision.,f,,,,t,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,INDUSTRY,,,,,,,2021,0.0
NCT04843852,,2021-04-06,,,2022-07-19,2021-04-09,2021-04-14,ACTUAL,,,,,,,2022-07-19,2022-07-22,ACTUAL,2022-07,ESTIMATED,2022-07-31,2022-07,2022-07-31,2024-07,ESTIMATED,2024-07-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,BOOST-9,,TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B,Augmentation of Humoral Immunity Using Toll-Like Receptor (TLR) 9 Adjuvanted HBV Surface Antigen to Enhance Anti-HBSAg Response,WITHDRAWN,,PHASE1,0.0,ACTUAL,"University of Maryland, Baltimore",,2.0,,Study not implemented,f,,,,f,t,f,,,f,,,,,,UNDECIDED,,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,OTHER,,,,,,,2024,0.0
NCT02808650,,2016-06-15,2023-09-29,,2023-12-18,2016-06-21,2016-06-22,ESTIMATED,2023-12-18,2023-12-20,ACTUAL,,,,2023-12-18,2023-12-20,ACTUAL,2017-02-27,ACTUAL,2017-02-27,2023-12,2023-12-31,2021-03-31,ACTUAL,2021-03-31,2019-12-31,ACTUAL,2019-12-31,,INTERVENTIONAL,,,Prexasertib in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors,"A Phase 1 Study of LY2606368 (Prexasertib Mesylate Monohydrate) a CHK1/2 Inhibitor, in Pediatric Patients With Recurrent or Refractory Solid Tumors, Including CNS Tumors",COMPLETED,,PHASE1,30.0,ACTUAL,Children's Oncology Group,,1.0,,,,,,,f,t,f,,,,,,,,,,,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,NETWORK,,,,,,,2021,0.0
NCT04856891,,2021-04-20,2023-12-13,,2023-12-13,2021-04-20,2021-04-23,ACTUAL,2023-12-13,2024-01-02,ACTUAL,,,,2023-12-13,2024-01-02,ACTUAL,2021-05-20,ACTUAL,2021-05-20,2023-12,2023-12-31,2023-01-09,ACTUAL,2023-01-09,2022-06-14,ACTUAL,2022-06-14,,INTERVENTIONAL,EoDyssey,,A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis,"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Duodenitis Who Have an Inadequate Response With, Lost Response to, or Were Intolerant to Standard Therapies",COMPLETED,,PHASE3,94.0,ACTUAL,Allakos Inc.,,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,INDUSTRY,,,,,,,2023,1.0
NCT02673229,,2016-02-01,2021-05-10,,2024-07-08,2016-02-02,2016-02-03,ESTIMATED,2024-07-08,2024-07-10,ACTUAL,,,,2024-07-08,2024-07-10,ACTUAL,2013-09-30,ACTUAL,2013-09-30,2024-07,2024-07-31,2020-03-30,ACTUAL,2020-03-30,2018-12-27,ACTUAL,2018-12-27,,INTERVENTIONAL,,"This is descriptive statistics on the demographic information for each group, the bacitracin group and the santyl group.",Comparison of Collagenase With Antibiotic Ointment of Minor Partial Thickness Burns,Comparison of Collagenase Santyl Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns,TERMINATED,,PHASE4,20.0,ACTUAL,University of Kansas Medical Center,,2.0,,slow enrollment due to cost of medication and conflict of interest enrolling uninsured patients,f,,,,f,,,,,,,,,,,,,2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,OTHER,,,,,,,2020,0.0
NCT03416374,,2018-01-23,2022-05-25,,2022-08-31,2018-01-30,2018-01-31,ACTUAL,2022-07-27,2022-08-22,ACTUAL,,,,2022-08-31,2022-09-27,ACTUAL,2018-02-18,ACTUAL,2018-02-18,2022-05,2022-05-31,2021-05-28,ACTUAL,2021-05-28,2021-05-28,ACTUAL,2021-05-28,,INTERVENTIONAL,,Full Analysis Set (FAS): all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.,A Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy,"An Open-label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy",COMPLETED,,PHASE4,45.0,ACTUAL,Takeda,,1.0,,,f,,,,f,t,f,,,t,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,INDUSTRY,,,,,,,2021,1.0
NCT03660345,,2018-09-04,,,2021-11-20,2018-09-04,2018-09-06,ACTUAL,,,,,,,2021-11-20,2021-12-02,ACTUAL,2018-09-04,ACTUAL,2018-09-04,2021-11,2021-11-30,2021-05-04,ACTUAL,2021-05-04,2021-05-04,ACTUAL,2021-05-04,,INTERVENTIONAL,,,PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME,Pars Plana Vitrectomy With Internal Limiting Membrane Peeling Versus Intravitreal Ziv-Aflibercept for Treatment-Naïve Diabetic Macular Edema,COMPLETED,,PHASE3,11.0,ACTUAL,Rush Eye Associates,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,OTHER,,,,,,,2021,1.0
NCT03161093,,2017-05-18,2022-08-25,2020-09-08,2022-10-18,2017-05-18,2017-05-19,ACTUAL,2022-10-18,2022-11-14,ACTUAL,2022-10-18,2022-11-14,ACTUAL,2022-10-18,2022-11-14,ACTUAL,2017-08-17,ACTUAL,2017-08-17,2022-10,2022-10-31,2021-08-27,ACTUAL,2021-08-27,2019-09-09,ACTUAL,2019-09-09,,INTERVENTIONAL,FACT OA1,,A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip,"A Phase 3 Randomized, Double-blind, Multi-dose, Placebo and Naproxen-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip",COMPLETED,,PHASE3,3307.0,ACTUAL,Regeneron Pharmaceuticals,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,INDUSTRY,,,,,,,2021,1.0
NCT04907851,,2021-05-25,,,2024-03-06,2021-05-28,2021-06-01,ACTUAL,,,,,,,2024-03-06,2024-03-08,ACTUAL,2021-12-10,ACTUAL,2021-12-10,2024-03,2024-03-31,2023-11-30,ACTUAL,2023-11-30,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,KEYNOTE-E86,,A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2),"A Modular, Phase II, Open-Label, Multicentre Study to Assess the Preliminary Efficacy and Safety of RXC004, in Patients With Advanced Solid Tumours That Have Progressed Following Therapy With Current Standard of Care",COMPLETED,,PHASE2,45.0,ACTUAL,Redx Pharma Ltd,,3.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,INDUSTRY,,,,,,,2023,0.0
NCT02160782,,2014-06-09,2021-03-02,,2021-06-23,2014-06-09,2014-06-11,ESTIMATED,2021-06-23,2021-07-14,ACTUAL,,,,2021-06-23,2021-07-14,ACTUAL,2014-10-28,ACTUAL,2014-10-28,2021-06,2021-06-30,2020-05-28,ACTUAL,2020-05-28,2020-05-28,ACTUAL,2020-05-28,,INTERVENTIONAL,ICONIC,,Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS),"Long-Term, Open-Label Study With a Double-Blind, Placebo-Controlled, Randomized Drug Withdrawal Period of LUM001 (Maralixibat), an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Alagille Syndrome",COMPLETED,,PHASE2,31.0,ACTUAL,"Mirum Pharmaceuticals, Inc.",Limitations of the trial such as small numbers of subjects analyzed or technical problems leading to unreliable data.,2.0,,,t,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,INDUSTRY,,NCT04530994,APPROVED_FOR_MARKETING,,,,2020,1.0
NCT05933070,,2023-06-02,,,2024-07-17,2023-07-03,2023-07-06,ACTUAL,,,,,,,2024-07-17,2024-07-18,ACTUAL,2020-06-15,ACTUAL,2020-06-15,2024-07,2024-07-31,2024-04-26,ACTUAL,2024-04-26,2024-03-28,ACTUAL,2024-03-28,,INTERVENTIONAL,LAUREL,,A Phase I Open-Label Dose Escalation Study of Intravenous INKmune In Patients With MDS or AML,A Phase I Open-Label Dose Escalation Study Of Intravenous INKmune In Patients With Myelodysplastic Syndrome With Excess Blasts (MDS-EB-1/2 - MDS-CMML 1/2) Or Acute Myeloid Leukaemia (AML),TERMINATED,,PHASE1,2.0,ACTUAL,"Inmune Bio, Inc.",,1.0,,Slow/low Enrollment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,INDUSTRY,,,,,,,2024,0.0
NCT04780581,,2021-02-15,,,2022-06-10,2021-03-02,2021-03-03,ACTUAL,,,,,,,2022-06-10,2022-06-14,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2022-06,2022-06-30,2021-11-09,ACTUAL,2021-11-09,2021-11-09,ACTUAL,2021-11-09,,INTERVENTIONAL,,,Glucocorticoid Therapy in Coronavirus Disease COVID-19 Patients,MP3-pulses-COVID-19. Methylprednisolone Pulses Versus Dexamethasone According RECOVERY Protocol in Patients With Pneumonia Due to SARS-COV-2 Coronavirus Infection,TERMINATED,,PHASE4,127.0,ACTUAL,Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León,,2.0,,Impossibility of reaching the sample size established by protocol,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,OTHER,,,,,,,2021,0.0
NCT03198143,,2017-05-25,,,2020-01-23,2017-06-22,2017-06-26,ACTUAL,,,,,,,2020-01-23,2020-01-27,ACTUAL,2019-10,ESTIMATED,2019-10-31,2020-01,2020-01-31,2022-02,ESTIMATED,2022-02-28,2021-02,ESTIMATED,2021-02-28,,INTERVENTIONAL,,,Effect of Ghrelin on Decision-Making,Effect of Ghrelin on Nutritional and Financial Decision-Making,WITHDRAWN,,PHASE1,0.0,ACTUAL,Duke University,,4.0,,PI leaving institution,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,OTHER,,,,,,,2022,0.0
NCT04343651,,2020-03-31,2022-07-28,,2022-12-08,2020-04-09,2020-04-13,ACTUAL,2022-12-08,2023-01-04,ACTUAL,,,,2022-12-08,2023-01-04,ACTUAL,2020-04-01,ACTUAL,2020-04-01,2022-12,2022-12-31,2021-09-20,ACTUAL,2021-09-20,2020-07-21,ACTUAL,2020-07-21,,INTERVENTIONAL,,The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of leronlimab or placebo and is population used for the analysis of efficacy parameters or measurements.~The Safety Population includes all subjects who received at least one dose of leronlimab or placebo. This population was used for the analysis of safety parameters or measurements. There were 84 subjects in the MITT and Safety Population.,Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19,"A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19)",COMPLETED,,PHASE2,86.0,ACTUAL,"CytoDyn, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,INDUSTRY,,,,,,,2021,1.0
NCT03367871,,2017-12-05,2024-01-30,,2024-05-24,2017-12-05,2017-12-11,ACTUAL,2024-05-24,2024-06-18,ACTUAL,,,,2024-05-24,2024-06-18,ACTUAL,2018-09-06,ACTUAL,2018-09-06,2024-05,2024-05-31,2023-01-30,ACTUAL,2023-01-30,2023-01-30,ACTUAL,2023-01-30,,INTERVENTIONAL,,,"Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer","Phase II Single Arm Study of Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Recurrent, Persistent, or Metastatic Cervical Cancer",TERMINATED,,PHASE2,17.0,ACTUAL,University of Miami,,1.0,,Investigator left institution,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,OTHER,,,,,,,2023,0.0
NCT03048461,,2017-02-07,,,2021-12-22,2017-02-07,2017-02-09,ESTIMATED,,,,,,,2021-12-22,2021-12-23,ACTUAL,2019-06,ESTIMATED,2019-06-30,2021-12,2021-12-31,2020-12,ESTIMATED,2020-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,The Effect of Platelet-rich Plasma in Subjects With Androgenetic Alopecia,"A Randomized, Double-blind, Placebo-controlled Clinical Trial Investigating the Effect of Autologous Platelet-rich Plasma in Subjects With Androgenetic Alopecia.",WITHDRAWN,,PHASE2,0.0,ACTUAL,Northwestern University,,2.0,,Did not want to enroll and proceed with this study concept.,f,,,,f,f,t,,,,,,,,,,,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,OTHER,,,,,,,2020,0.0
NCT03109795,,2017-04-04,2024-06-29,,2024-06-29,2017-04-10,2017-04-12,ACTUAL,2024-06-29,2024-07-29,ACTUAL,,,,2024-06-29,2024-07-29,ACTUAL,2017-04-10,ACTUAL,2017-04-10,2024-06,2024-06-30,2023-06-30,ACTUAL,2023-06-30,2023-06-30,ACTUAL,2023-06-30,,INTERVENTIONAL,ATLAS,Study was terminated before any participants were randomized,Anxiety-mediated Impairments in Large Elastic Artery Function and the Autonomic Nervous System,Anxiety-mediated Impairments in Large Elastic Artery Function and the Autonomic Nervous System,TERMINATED,,PHASE4,35.0,ACTUAL,University of Iowa,Study was terminated before any participants were randomized because of lack of funding.,2.0,,Funding ended,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,OTHER,,,,,,,2023,0.0
NCT04531592,,2020-08-21,,,2021-10-27,2020-08-26,2020-08-28,ACTUAL,,,,,,,2021-10-27,2021-10-29,ACTUAL,2022-01,ESTIMATED,2022-01-31,2021-10,2021-10-31,2023-06,ESTIMATED,2023-06-30,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,Valproic Acid (VPA) for Acute Kidney Injury (AKI) in Liver Transplant Patients,Evaluation of Valproic Acid (VPA) as Adjunctive Therapy for Liver Transplant Patients With Moderate to Severe Hemorrhage at Risk of Ischemia Reperfusion (I/R) Injury,WITHDRAWN,,PHASE2,0.0,ACTUAL,Westat,,2.0,,Study terminated by the Sponsor,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,OTHER,,,,,,,2023,0.0
NCT05011396,,2021-08-11,,,2023-07-11,2021-08-11,2021-08-18,ACTUAL,,,,,,,2023-07-11,2023-07-13,ACTUAL,2021-08-30,ACTUAL,2021-08-30,2023-07,2023-07-31,2022-08-16,ACTUAL,2022-08-16,2022-08-16,ACTUAL,2022-08-16,,INTERVENTIONAL,Palisade-2,,PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2,"A US, Phase 3 Multicenter, Randomized, Double-blind, Placebo Controlled Trial of PH94B Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder (PaliSADe-2)",TERMINATED,,PHASE3,324.0,ACTUAL,"VistaGen Therapeutics, Inc.",,2.0,,Study stopped by the sponsor for business reasons and not due to any safety concerns with PH94B,f,,,,f,t,f,,,,,,,,,,,2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,INDUSTRY,,,,,,,2022,0.0
NCT03809897,,2018-11-21,,,2019-03-08,2019-01-17,2019-01-18,ACTUAL,,,,,,,2019-03-08,2019-03-12,ACTUAL,2019-01,ESTIMATED,2019-01-31,2019-01,2019-01-31,2020-04,ESTIMATED,2020-04-30,2020-04,ESTIMATED,2020-04-30,,INTERVENTIONAL,,,Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders,An Effectiveness and Safety Study of Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders,WITHDRAWN,,PHASE4,0.0,ACTUAL,Hospital Universitari Vall d'Hebron Research Institute,,2.0,,Budget not sufficient to cover the study scope proposed and recruitment rates expected to be no sufficient.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,OTHER,,,,,,,2020,0.0
NCT03452839,,2018-02-26,,,2022-12-23,2018-03-01,2018-03-02,ACTUAL,,,,,,,2022-12-23,2022-12-27,ACTUAL,2018-06-05,ACTUAL,2018-06-05,2022-12,2022-12-31,2022-12-01,ACTUAL,2022-12-01,2022-10-01,ACTUAL,2022-10-01,,INTERVENTIONAL,MERCY,,Bolus Versus Continuous Infusion of Meropenem,Continuous Infusion Versus Intermittent Administration of Meropenem in Critically Ill Patients: A Multicenter Randomized Double Blind Trial,COMPLETED,,PHASE4,607.0,ACTUAL,Università Vita-Salute San Raffaele,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,OTHER,,,,,,,2022,0.0
NCT02319369,,2014-12-15,2021-08-04,,2021-09-14,2014-12-17,2014-12-18,ESTIMATED,2021-09-14,2021-10-11,ACTUAL,,,,2021-09-14,2021-10-11,ACTUAL,2014-11-25,ACTUAL,2014-11-25,2021-09,2021-09-30,2020-08-21,ACTUAL,2020-08-21,2020-08-21,ACTUAL,2020-08-21,,INTERVENTIONAL,,Baseline demographics were assessed in the Enrolled Analysis Set.,"Safety, Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine (AZA) in Acute Myelogenous Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)","A Phase 1 Study of Milademetan (DS 3032b), an Oral MDM2 Inhibitor, In Dose Escalation as a Single Agent and In Dose Escalation/Expansion In Combination With 5 Azacitidine In Subjects With Acute Myelogenous Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)",TERMINATED,,PHASE1,74.0,ACTUAL,Daiichi Sankyo,,5.0,,This study was terminated based on a business decision by the Sponsor.,f,,,,f,t,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,INDUSTRY,,,,,,,2020,0.0
NCT03422627,,2018-01-16,2023-11-02,,2023-11-02,2018-01-30,2018-02-06,ACTUAL,2023-11-02,2023-11-22,ACTUAL,,,,2023-11-02,2023-11-22,ACTUAL,2018-04-27,ACTUAL,2018-04-27,2023-10,2023-10-31,2022-10-13,ACTUAL,2022-10-13,2022-10-13,ACTUAL,2022-10-13,,INTERVENTIONAL,,"Measured in the safety analysis set, which included all participants who received at least 1 dose of efavaleukin alfa.",Safety and Efficacy of Efavaleukin Alfa in Subjects With Steroid Refractory Chronic Graft Versus Host Disease,"A Phase 1b/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Efavaleukin Alfa in Adult Subjects With Steroid Refractory Chronic Graft Versus Host Disease",TERMINATED,,PHASE1/PHASE2,32.0,ACTUAL,Amgen,,2.0,,Sponsor Decision,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,INDUSTRY,,,,,,,2022,0.0
NCT04365257,,2020-04-24,2022-11-30,,2023-03-16,2020-04-24,2020-04-28,ACTUAL,2023-01-12,2023-01-31,ACTUAL,,,,2023-03-16,2023-04-10,ACTUAL,2020-05-13,ACTUAL,2020-05-13,2023-03,2023-03-31,2022-03-31,ACTUAL,2022-03-31,2022-03-31,ACTUAL,2022-03-31,,INTERVENTIONAL,PREVENT,,Prazosin to Prevent COVID-19 (PREVENT-COVID Trial),Alpha-1 Adrenergic Receptor Antagonism to Prevent COVID-19 Cytokine Storm Syndrome and Acute Respiratory Distress Syndrome: A Randomized Study Comparing the Efficacy of Prazosin vs. Standard of Care for SARS-CoV-2 Infection,TERMINATED,,PHASE2,5.0,ACTUAL,Johns Hopkins University,,2.0,,Lack of recruitment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,OTHER,,,,,,,2022,0.0
NCT03238742,,2017-07-29,,,2021-01-01,2017-08-02,2017-08-03,ACTUAL,,,,,,,2021-01-01,2021-01-05,ACTUAL,2017-10-20,ACTUAL,2017-10-20,2021-01,2021-01-31,2020-01-08,ACTUAL,2020-01-08,2019-07-28,ACTUAL,2019-07-28,,INTERVENTIONAL,,,The Efficacy of Xuebijing Injection on Sepsis,The Efficacy of Xuebijing Injection in Adult Patients With Sepsis,COMPLETED,,PHASE4,1817.0,ACTUAL,"Southeast University, China",,2.0,,,f,,,,t,f,f,,,,,,Study published,Supplyment,,YES,Mortality,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,OTHER,,,,,,,2020,1.0
NCT03303989,,2017-09-29,2021-06-29,,2022-03-14,2017-10-05,2017-10-06,ACTUAL,2021-10-13,2021-11-10,ACTUAL,,,,2022-03-14,2022-03-16,ACTUAL,2018-06-14,ACTUAL,2018-06-14,2022-03,2022-03-31,2021-03-31,ACTUAL,2021-03-31,2020-04-27,ACTUAL,2020-04-27,,INTERVENTIONAL,RECIPE,"35 participants were randomized. Three participants withdrew after randomization, but prior to first pegloticase infusion. Baseline characteristics are of the 32 participants (22 in MMF+Peg, 10 in PBO+Peg)",REduCing Immunogenicity to PegloticasE (RECIPE) Study,REduCing Immunogenicity to PegloticasE (RECIPE) Study,COMPLETED,,PHASE2,35.0,ACTUAL,University of Alabama at Birmingham,,2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 05:51:30.79745,2024-10-16 05:51:30.79745,OTHER,,,,,,,2021,1.0
NCT01238120,,2010-11-09,2020-12-21,,2021-04-13,2010-11-09,2010-11-10,ESTIMATED,2021-02-24,2021-03-17,ACTUAL,,,,2021-04-13,2021-05-05,ACTUAL,2010-11,,2010-11-30,2021-04,2021-04-30,2020-12,ACTUAL,2020-12-31,2019-12,ACTUAL,2019-12-31,,INTERVENTIONAL,,,The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients,A Phase II Study of the Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients Undergoing Chemotherapy,COMPLETED,,PHASE2,110.0,ACTUAL,University of Rochester,,4.0,,,f,,,,t,t,f,,,f,,,,,,NO,"Overall study results will be presented to participants, faculty and staff at the University of Rochester Medical Center. tudy results will be presented at professional meetings and published",2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,OTHER,,,,,,,2020,1.0
NCT05212025,,2022-01-06,,,2022-06-10,2022-01-23,2022-01-27,ACTUAL,,,,,,,2022-06-10,2022-06-14,ACTUAL,2022-06,ESTIMATED,2022-06-30,2022-06,2022-06-30,2023-12-31,ESTIMATED,2023-12-31,2023-06-01,ESTIMATED,2023-06-01,,INTERVENTIONAL,,,Adavosertib and Gemcitabine in Advanced Pancreatic,Phase 2 Single Arm Trial Testing Adavosertib and Gemcitabine in Platinum-Resistant Advanced Pancreatic Adenocarcinoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,manufacturer choice,f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,OTHER,,,,,,,2023,0.0
NCT05323110,,2022-04-05,,,2023-09-21,2022-04-05,2022-04-12,ACTUAL,,,,,,,2023-09-21,2023-09-22,ACTUAL,2022-04-14,ACTUAL,2022-04-14,2023-09,2023-09-30,2023-08-22,ACTUAL,2023-08-22,2023-08-22,ACTUAL,2023-08-22,,INTERVENTIONAL,,,Study of Intravenously Administered Anti-LIGHT Monoclonal Antibody CBS001 in Healthy Volunteers,"A Double-blind, Randomized, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Single- and Multiple-ascending Doses of Intravenously Administered Anti-LIGHT Monoclonal Antibody CBS001 in Healthy Volunteers",TERMINATED,,PHASE1,56.0,ACTUAL,Capella Bioscience Ltd,,11.0,,Portfolio reprioritization,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,INDUSTRY,,,,,,,2023,0.0
NCT03141073,,2017-04-28,,,2021-08-24,2017-05-02,2017-05-04,ACTUAL,,,,,,,2021-08-24,2021-08-26,ACTUAL,2017-10-15,ACTUAL,2017-10-15,2021-02,2021-02-28,2021-02-28,ACTUAL,2021-02-28,2021-02-28,ACTUAL,2021-02-28,,INTERVENTIONAL,,,Long-term Efficacy and Safety of HMS5552 add-on to Metformin in T2DM Subjects,"A 24-week Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HMS5552 add-on to Metformin With Additional 28-week Open-label Treatment to Evaluate the Safety in T2DM Subjects",COMPLETED,,PHASE3,767.0,ACTUAL,Hua Medicine Limited,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,INDUSTRY,,,,,,,2021,1.0
NCT05412706,,2022-05-25,,,2023-09-05,2022-06-07,2022-06-09,ACTUAL,,,,,,,2023-09-05,2023-09-08,ACTUAL,2023-09-04,ACTUAL,2023-09-04,2023-09,2023-09-30,2023-09-04,ACTUAL,2023-09-04,2023-09-04,ACTUAL,2023-09-04,,INTERVENTIONAL,Bohème,,Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy,Niraparib Maintenance Treatment in Metastatic Colorectal Cancer Patients With a Partial or Complete Response After Oxaliplatin-based Induction Therapy: Bohème Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,Ospedale Policlinico San Martino,,1.0,,The Principal Investigator has retired and has not been replaced has retired and a new one has not been identified Principal Investigator,f,,,,f,f,f,,,,,,,,,,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,OTHER,,,,,,,2023,0.0
NCT03968419,,2019-05-15,2023-06-12,2022-07-05,2024-06-17,2019-05-29,2019-05-30,ACTUAL,2023-06-12,2023-07-03,ACTUAL,2022-07-05,2022-07-06,ACTUAL,2024-06-17,2024-06-20,ACTUAL,2019-11-05,ACTUAL,2019-11-05,2024-06,2024-06-30,2022-08-15,ACTUAL,2022-08-15,2022-04-20,ACTUAL,2022-04-20,,INTERVENTIONAL,CANOPY-N,,This Study Will Evaluate the Effect of Canakinumab or Pembrolizumab Given as Monotherapy or in Combination as Neo-adjuvant Treatment for Subjects With Early Stages NSCLC.,"A Randomized, Open-label, Phase II Study of Canakinumab or Pembrolizumab as Monotherapy or in Combination as Neoadjuvant Therapy in Subjects With Resectable Non-small Cell Lung Cancer (CANOPY-N)",TERMINATED,,PHASE2,88.0,ACTUAL,Novartis,,3.0,,Study early terminated due to low enrollment compared to the anticipated figures.,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.",2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,INDUSTRY,,,,,,,2022,0.0
NCT02698189,,2016-02-29,2018-12-19,,2022-08-23,2016-02-29,2016-03-03,ESTIMATED,2019-07-16,2019-07-23,ACTUAL,,,,2022-08-23,2022-09-13,ACTUAL,2016-05-19,ACTUAL,2016-05-19,2022-08,2022-08-31,2021-09-09,ACTUAL,2021-09-09,2018-01-18,ACTUAL,2018-01-18,,INTERVENTIONAL,,All enrolled participants,A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Hematologic Malignancies (MK-8628-005),"A Phase IB Trial With MK-8628, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Subjects With Selected Hematologic Malignancies",TERMINATED,,PHASE1,9.0,ACTUAL,Merck Sharp & Dohme LLC,"Due to limited pharmacokinetics sampling for t1/2, caution must be exercised when interpreting the results of t1/2, CL/F, and AUC 0-∞ results.",2.0,,This study was terminated due to limited efficacy and not due to safety reasons,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,INDUSTRY,,,,,,,2021,0.0
NCT05284812,,2022-02-21,,,2023-11-22,2022-03-09,2022-03-17,ACTUAL,,,,,,,2023-11-22,2023-11-28,ACTUAL,2022-02-10,ACTUAL,2022-02-10,2023-11,2023-11-30,2024-12-31,ESTIMATED,2024-12-31,2024-06-30,ESTIMATED,2024-06-30,,INTERVENTIONAL,,,A Phase Ⅱ Clinical Trial of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02),"A Phase Ⅱ Study on the Safety, Tolerability and Immunogenicity of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried",SUSPENDED,,PHASE2,200.0,ESTIMATED,"Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.",,7.0,,It is planned to restart the clinical study after the completion of the clinical trial protocol modification.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,INDUSTRY,,,,,,,2024,0.0
NCT04203901,,2019-12-10,,,2023-09-28,2019-12-17,2019-12-18,ACTUAL,,,,,,,2023-09-28,2023-10-02,ACTUAL,2020-07-22,ACTUAL,2020-07-22,2023-09,2023-09-30,2023-09-28,ACTUAL,2023-09-28,2023-09-28,ACTUAL,2023-09-28,,INTERVENTIONAL,,,Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma,A Phase 2b Randomized Trial of Autologous Dendritic Cell Immunotherapy (CMN-001) Plus Standard Treatment of Advanced Renal Cell Carcinoma,TERMINATED,,PHASE2,16.0,ACTUAL,CoImmune,,2.0,,Strategic corporate decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,INDUSTRY,,,,,,,2023,0.0
NCT03870841,,2018-10-24,,,2021-07-15,2019-03-08,2019-03-12,ACTUAL,,,,,,,2021-07-15,2021-07-16,ACTUAL,2019-04-03,ACTUAL,2019-04-03,2021-07,2021-07-31,2020-06-01,ACTUAL,2020-06-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,,,The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis,"An Open-label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Inhaled PC945 in Adult Cystic Fibrosis (CF) Patients With Persistent Pulmonary Aspergillus Fumigatus Infection",TERMINATED,,PHASE2,4.0,ACTUAL,Pulmocide Ltd,,1.0,,The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.,f,,,,,f,f,,,,,,,,,,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,INDUSTRY,,,,,,,2020,0.0
NCT05158153,,2021-11-19,2023-04-18,,2023-04-18,2021-12-14,2021-12-15,ACTUAL,2023-04-18,2023-05-12,ACTUAL,,,,2023-04-18,2023-05-12,ACTUAL,2021-10-18,ACTUAL,2021-10-18,2023-04,2023-04-30,2022-04-19,ACTUAL,2022-04-19,2022-04-19,ACTUAL,2022-04-19,,INTERVENTIONAL,ORKID,,Outpatient Recovery From Acute Kidney Injury Requiring Dialysis,Outpatient Recovery From Acute Kidney Injury Requiring Dialysis,TERMINATED,,PHASE4,1.0,ACTUAL,"University of California, San Francisco",,1.0,,Inadequate recruitment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,OTHER,,,,,,,2022,0.0
NCT03501056,,2018-04-10,,,2020-10-13,2018-04-10,2018-04-18,ACTUAL,,,,,,,2020-10-13,2020-10-19,ACTUAL,2018-03-27,ACTUAL,2018-03-27,2020-05,2020-05-31,2020-07-27,ACTUAL,2020-07-27,2020-05-25,ACTUAL,2020-05-25,,INTERVENTIONAL,,,Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Lung Cancer,Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Lung Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Fuda Cancer Hospital, Guangzhou",,3.0,,No participants enrolled,f,,,,,f,f,,,,,,,,,,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,OTHER,,,,,,,2020,0.0
NCT04598542,,2020-10-06,,,2021-01-08,2020-10-16,2020-10-22,ACTUAL,,,,,,,2021-01-08,2021-01-12,ACTUAL,2020-10-13,ACTUAL,2020-10-13,2021-01,2021-01-31,2020-12-22,ACTUAL,2020-12-22,2020-12-22,ACTUAL,2020-12-22,,INTERVENTIONAL,,,Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers,"Open-Label, Parallel-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Corticosteroid Intra Articular Injection Given 7 Days Before or 7 Days After Lorecivivint Intra-articular Injection Into the Knee of Healthy Volunteers",COMPLETED,,PHASE1,40.0,ACTUAL,"Biosplice Therapeutics, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,INDUSTRY,,,,,,,2020,1.0
NCT03244059,,2017-08-03,2023-04-20,,2023-06-26,2017-08-07,2017-08-09,ACTUAL,2023-06-26,2023-07-18,ACTUAL,,,,2023-06-26,2023-07-18,ACTUAL,2018-08-09,ACTUAL,2018-08-09,2023-06,2023-06-30,2022-04-01,ACTUAL,2022-04-01,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,BOTEGA,,Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies,"Proof-of-concept Randomized, Double-blind, Phase IIa Study to Show Feasibility, Validate Assays and Approaches, and Explore Dosing and Safety of Belimumab in Pulmonary Emphysema Patients",COMPLETED,,PHASE2,17.0,ACTUAL,University of Alabama at Birmingham,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,OTHER,,,,,,,2022,1.0
NCT04472728,,2020-07-06,,,2023-05-12,2020-07-13,2020-07-15,ACTUAL,,,,,,,2023-05-12,2023-05-15,ACTUAL,2020-08-26,ACTUAL,2020-08-26,2022-04,2022-04-30,2022-09-30,ACTUAL,2022-09-30,2022-06-06,ACTUAL,2022-06-06,,INTERVENTIONAL,COVA,,Testing the Efficacy and Safety of BIO101 for the Prevention of Respiratory Deterioration in COVID-19 Patients,"Adaptive Design Phase 2 to 3, Randomized, Double-blind, to Evaluate Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BIO101 in the Prevention of the Respiratory Deterioration in Hospitalized COVID-19 Patients",TERMINATED,,PHASE2/PHASE3,238.0,ACTUAL,Biophytis,,2.0,,Lack of eligible patients due to lower number of Covid-19 cases in all involved sites.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,INDUSTRY,,,,,,,2022,0.0
NCT01244737,,2010-10-29,2024-02-05,,2024-06-15,2010-11-18,2010-11-19,ESTIMATED,2024-06-15,2024-07-11,ACTUAL,,,,2024-06-15,2024-07-11,ACTUAL,2010-10,ACTUAL,2010-10-31,2024-06,2024-06-30,2023-02-05,ACTUAL,2023-02-05,2023-02-05,ACTUAL,2023-02-05,,INTERVENTIONAL,,,FLT-PET Imaging of Brain Tumors in Children,Phase 2 Study of [18F]FLT for PET Imaging of Brain Tumors in Children,COMPLETED,,PHASE2,50.0,ACTUAL,Boston Children's Hospital,"Arm 3: Despite much recruitment effort, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment.",3.0,,,f,,,,f,t,f,,,,,,,,,NO,No current plans to share individual participant data,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,OTHER,,,,,,,2023,1.0
NCT04005170,,2019-06-26,,,2022-08-21,2019-06-30,2019-07-02,ACTUAL,,,,,,,2022-08-21,2022-08-23,ACTUAL,2019-06-25,ACTUAL,2019-06-25,2022-08,2022-08-31,2022-07-31,ACTUAL,2022-07-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Combination of Toripalimab and Chemoradiotherapy in Esophageal Cancer,A Phase II Trial of Combination of Toripalimab and Definitive Chemoradiotherapy in Esophageal Squamous Cell Carcinoma,COMPLETED,,PHASE2,42.0,ACTUAL,Sun Yat-sen University,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,OTHER,,,,,,,2022,1.0
NCT04452643,,2020-06-26,,,2020-10-29,2020-06-26,2020-06-30,ACTUAL,,,,,,,2020-10-29,2020-11-02,ACTUAL,2020-10,ESTIMATED,2020-10-31,2020-10,2020-10-31,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,Bacmune,,Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to COVID-19 Infection in Healthcare Personnel,"Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to SARS-CoV-2 Infection in Healthcare Personnel",WITHDRAWN,,PHASE3,0.0,ACTUAL,Inmunotek S.L.,,2.0,,Not authorized by Cofepris (Mexico Competent Regulatory Authority),f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,INDUSTRY,,,,,,,2021,0.0
NCT04026568,,2019-07-17,2022-07-28,,2022-10-12,2019-07-18,2019-07-19,ACTUAL,2022-08-22,2022-09-14,ACTUAL,,,,2022-10-12,2022-10-18,ACTUAL,2021-08-17,ACTUAL,2021-08-17,2022-10,2022-10-31,2022-07-18,ACTUAL,2022-07-18,2022-07-18,ACTUAL,2022-07-18,,INTERVENTIONAL,,Subject enrolled from Orthopaedic Trauma service for traumatic peripheral nerve injury.,A Single Dose Pharmaco-Diagnostic for Peripheral Nerve Continuity After Trauma,A Single Dose Pharmaco-Diagnostic for Peripheral Nerve Continuity After Trauma,TERMINATED,,PHASE2/PHASE3,1.0,ACTUAL,Milton S. Hershey Medical Center,The study was terminated early due to lack of funding and the investigator and IND holder leaving the institution.,2.0,,Study investigator left Institution,f,,,,t,t,f,,,,,,,,,NO,"The results include both subjective and objective measures. Subjective measures will not be hidden from patients given the nature of measurements. Active discussion of objective measures will wait until final follow up at 20 weeks. Patients can use their subjective assessments in their standard-of-care treatment decisions and with their doctors. Investigators will not inform other physicians except at the consent of patients. Objective test results will not be discussed with treating physicians until 20 weeks. If a patient wants further surgical exploration of an injured peripheral nerve based on subjective return of function (or lack) with members of the study team, a patient conference will be arranged with ethicist and DSMB (Data Safety Monitoring Board). The patient's decision in conjunction with the treating surgeon (not on study team to avoid any conflicts) is to be paramount. Unblinding will also be discussed then with the DSMB.",2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,OTHER,,,,,,,2022,0.0
NCT01770340,,2012-12-13,,,2021-02-18,2013-01-15,2013-01-17,ESTIMATED,,,,,,,2021-02-18,2021-02-21,ACTUAL,2011-01,,2011-01-31,2021-02,2021-02-28,2020-07-01,ACTUAL,2020-07-01,2017-04,ACTUAL,2017-04-30,,INTERVENTIONAL,,,Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial,Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial,TERMINATED,,PHASE4,30.0,ACTUAL,Kantonsspital Winterthur KSW,,2.0,,"Poor recruitment, Interim analysis: The rates of pts who reached primary and secondary endpoints were lower than expected.",f,,,,t,,,,,,,,,,,,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,OTHER,,,,,,,2020,0.0
NCT03951649,,2019-05-14,2023-10-17,,2023-11-30,2019-05-14,2019-05-15,ACTUAL,2023-11-30,2023-12-20,ACTUAL,,,,2023-11-30,2023-12-20,ACTUAL,2020-02-10,ACTUAL,2020-02-10,2023-11,2023-11-30,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine,Acute Headache Treatment in Pregnancy: Improvement in Pain Scores With Occipital Nerve Block vs PO Acetaminophen With Caffeine A Randomized Controlled Trial,COMPLETED,,PHASE4,62.0,ACTUAL,University of Alabama at Birmingham,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,OTHER,,,,,,,2022,1.0
NCT05674448,,2022-12-30,,,2023-10-06,2022-12-30,2023-01-06,ACTUAL,,,,,,,2023-10-06,2023-10-10,ACTUAL,2021-08-11,ACTUAL,2021-08-11,2022-12,2022-12-31,2023-01-04,ACTUAL,2023-01-04,2022-07-25,ACTUAL,2022-07-25,,INTERVENTIONAL,,,A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and Hepatitis D Co-infection,An Open-label Phase IIa Study to Evaluate the Antiviral Effect and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and D Co-infection,TERMINATED,,PHASE2,9.0,ACTUAL,Huahui Health,,2.0,,"During the study, the sponsor adjusted the overall clinical development strategy, decided to terminate the enrollment in advance after discussion with the lead investigator.",f,,,,,f,f,,,,,,,,,,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,INDUSTRY,,,,,,,2023,0.0
NCT02494570,,2015-07-08,2022-12-12,,2023-03-14,2015-07-09,2015-07-10,ESTIMATED,2023-03-14,2023-04-07,ACTUAL,,,,2023-03-14,2023-04-07,ACTUAL,2015-10,,2015-10-31,2023-03,2023-03-31,2022-04,ACTUAL,2022-04-30,2021-11,ACTUAL,2021-11-30,,INTERVENTIONAL,AMPECT,Safety Analysis Set: patients treated with nab-sirolimus (N = 34),A Phase 2 Study of Nab-sirolimus (ABI-009) in Patients With Advanced Malignant PEComa,A Phase 2 Multi-center Investigation of Efficacy of ABI-009 (Nab-sirolimus) in Patients With Advanced Malignant Perivascular Epithelioid Cell Tumors (PEComa),COMPLETED,,PHASE2,34.0,ACTUAL,"Aadi Bioscience, Inc.",,1.0,,,t,,,,t,t,f,,,,,,,,,,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,INDUSTRY,,NCT03817515,APPROVED_FOR_MARKETING,,,,2022,1.0
NCT03244358,,2017-07-23,,,2021-01-26,2017-08-08,2017-08-09,ACTUAL,,,,,,,2021-01-26,2021-01-29,ACTUAL,2017-03-01,ACTUAL,2017-03-01,2021-01,2021-01-31,2020-12-01,ACTUAL,2020-12-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,,,Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer,"Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer:A Single Arm,Single Center,Phase II Study",TERMINATED,,PHASE2,12.0,ACTUAL,Sun Yat-sen University,,1.0,,Difficulty accruing subjects the study accrual was closed,f,,,,,f,f,,,f,,,,,,NO,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,OTHER,,,,,,,2020,0.0
NCT05068284,,2021-09-27,2024-07-17,,2024-09-05,2021-09-27,2021-10-05,ACTUAL,2024-09-05,2024-10-03,ACTUAL,,,,2024-09-05,2024-10-03,ACTUAL,2022-01-31,ACTUAL,2022-01-31,2024-09,2024-09-30,2023-07-20,ACTUAL,2023-07-20,2023-07-20,ACTUAL,2023-07-20,,INTERVENTIONAL,AIM-CD,ITT1 population; all enrolled,A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's Disease,"A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Crohn's Disease (CD): AIM-CD",TERMINATED,,PHASE2,176.0,ACTUAL,AbbVie,AbbVie has decided to discontinue further subject enrollment in the M20-371 (ABBV-154) study. This decision is not based on a safety or an efficacy signal; rather this decision was made because of a change in AbbVie's development.,10.0,,Strategic considerations,f,,,,t,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,INDUSTRY,,,,,,,2023,0.0
NCT05574166,,2022-10-06,,,2022-10-06,2022-10-06,2022-10-10,ACTUAL,,,,,,,2022-10-06,2022-10-10,ACTUAL,2021-01-03,ACTUAL,2021-01-03,2022-10,2022-10-31,2021-10-29,ACTUAL,2021-10-29,2021-10-28,ACTUAL,2021-10-28,,INTERVENTIONAL,,,A Phase I Study to Evaluate Safety and Pharmacokinetics of Escalating Single Doses and Multiple Doses of SP-8356,"A Phase I Single-Centre, Randomised, Double-Blind, Placebo-Controlled Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses and Multiple Doses of SP-8356",TERMINATED,,PHASE1,31.0,ACTUAL,Shin Poong Pharmaceutical Co. Ltd.,,2.0,,"Only Part 1 was conducted but not Part 2. Due to the low exposures, definitive safety conclusions could not be made for the targeted exposure levels in the future.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,INDUSTRY,,,,,,,2021,0.0
NCT05064735,,2021-09-22,2024-07-20,,2024-07-20,2021-09-22,2021-10-01,ACTUAL,2024-07-20,2024-08-13,ACTUAL,,,,2024-07-20,2024-08-13,ACTUAL,2021-10-01,ACTUAL,2021-10-01,2024-07,2024-07-31,2023-09-08,ACTUAL,2023-09-08,2023-07-24,ACTUAL,2023-07-24,,INTERVENTIONAL,,Full analysis set (FAS) included all randomized participants according to the intention-to-treat principle.,Research Study Looking at How Well Semaglutide Works in People Suffering From Obesity and Knee Osteoarthritis,Effect of Subcutaneous Semaglutide 2.4 mg Once-weekly Compared to Placebo in Subjects With Obesity and Knee Osteoarthritis,COMPLETED,,PHASE3,407.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,INDUSTRY,,,,,,,2023,1.0
NCT01533727,,2012-02-12,,,2013-12-05,2012-02-14,2012-02-15,ESTIMATED,,,,,,,2013-12-05,2013-12-09,ESTIMATED,2011-08,,2011-08-31,2012-02,2012-02-29,2020-12,ESTIMATED,2020-12-31,2017-12,ESTIMATED,2017-12-31,,INTERVENTIONAL,,,CIK Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC),"A Phase 2,Open-label Study of Autologous Cytokine-Induced Killer Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer",WITHDRAWN,,PHASE2,0.0,ACTUAL,Sun Yat-sen University,,2.0,,"Few patients would like to participate ,since CIK cell transfusion was a new treatment and its efficacy was doubted.",f,,,,t,,,,,,,,,,,,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,OTHER,,,,,,,2020,0.0
NCT02811744,,2016-06-20,2023-03-17,,2024-01-10,2016-06-20,2016-06-23,ESTIMATED,2024-01-10,2024-01-11,ACTUAL,,,,2024-01-10,2024-01-11,ACTUAL,2017-01,ACTUAL,2017-01-31,2024-01,2024-01-31,2022-02-28,ACTUAL,2022-02-28,2022-02-28,ACTUAL,2022-02-28,,INTERVENTIONAL,,,11C-Acetate PET/CT Imaging As a Biomarker of Amyloid-Induced Neuroinflammation,11C-Acetate Position Emission Tomography/Computerized Tomography (PET/CT) Imaging As a Biomarker of Amyloid-Induced Neuroinflammation,TERMINATED,,PHASE2,11.0,ACTUAL,University of Pennsylvania,,2.0,,Funding issues.,f,,,,f,,,,,,,,,,,UNDECIDED,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,OTHER,,,,,,,2022,0.0
NCT04800315,,2021-03-12,2023-11-08,2023-07-14,2023-12-14,2021-03-12,2021-03-16,ACTUAL,2023-12-14,2024-01-03,ACTUAL,,2024-01-03,ACTUAL,2023-12-14,2024-01-03,ACTUAL,2021-05-14,ACTUAL,2021-05-14,2023-12,2023-12-31,2022-11-09,ACTUAL,2022-11-09,2022-07-20,ACTUAL,2022-07-20,,INTERVENTIONAL,,All Randomized,A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis,"A Phase 2, Multicenter, Global, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Cendakimab (CC-93538) in Adult Subjects With Moderate to Severe Atopic Dermatitis",COMPLETED,,PHASE2,221.0,ACTUAL,Celgene,,4.0,,,f,,,,t,t,f,,,,,,See Plan Description,See Plan Description,https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,INDUSTRY,,,,,,,2022,1.0
NCT04348461,,2020-04-10,,,2021-03-15,2020-04-14,2020-04-16,ACTUAL,,,,,,,2021-03-15,2021-03-17,ACTUAL,2020-05-06,ACTUAL,2020-05-06,2020-05,2020-05-31,2021-09-30,ESTIMATED,2021-09-30,2020-09-15,ACTUAL,2020-09-15,,INTERVENTIONAL,,,BAttLe Against COVID-19 Using MesenchYmal Stromal Cells,"Two-treatment,Randomized, Controlled, Multicenter Clinical Trial to Assess the Safety and Efficacy of Intravenous Administration of Expanded Allogeneic Adipose Tissue Adult Mesenchymal Stromal Cells in Critically Ill Patients COVID-19",SUSPENDED,,PHASE2,100.0,ESTIMATED,Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz,,2.0,,lack of financial support,f,,,,,f,f,,,,,,,,,,,2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,OTHER,,,,,,,2021,0.0
NCT04072575,,2019-08-16,2023-05-03,,2023-05-03,2019-08-27,2019-08-28,ACTUAL,2023-05-03,2023-05-31,ACTUAL,,,,2023-05-03,2023-05-31,ACTUAL,2019-09-19,ACTUAL,2019-09-19,2023-05,2023-05-31,2022-05-03,ACTUAL,2022-05-03,2022-05-03,ACTUAL,2022-05-03,,INTERVENTIONAL,,,A Study of Paliperidone Palmitate 6-Month Formulation,"Single-arm, Open-label Extension to a Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation",COMPLETED,,PHASE3,178.0,ACTUAL,"Janssen Research & Development, LLC",The sponsor identified that the study did not include a control arm reference group. The coronavirus disease-2019 (COVID-19) pandemic placed some restrictions on study face-to-face visits.,1.0,,,f,,,,f,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 07:57:44.002671,2024-10-15 07:57:44.002671,INDUSTRY,,,,,,,2022,1.0
NCT01926587,,2013-08-18,,,2021-06-15,2013-08-20,2013-08-21,ESTIMATED,,,,,,,2021-06-15,2021-06-16,ACTUAL,2013-08,,2013-08-31,2021-06,2021-06-30,2021-02-16,ACTUAL,2021-02-16,2020-12-08,ACTUAL,2020-12-08,,INTERVENTIONAL,,,Phase II Part 2 Expansion of Oral Rigosertib in Combination With Azacitidine,"A Phase I/II, Multi-center, Dose-escalating Study of the Tolerability, Pharmacokinetics, and Clinical Activity of the Combined Administration of Oral Rigosertib With Azacitidine in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia",COMPLETED,,PHASE1/PHASE2,45.0,ACTUAL,"Traws Pharma, Inc.",,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,INDUSTRY,,,,,,,2021,1.0
NCT05107427,,2021-10-08,,,2023-04-14,2021-10-25,2021-11-04,ACTUAL,,,,,,,2023-04-14,2023-04-18,ACTUAL,2022-03-01,ACTUAL,2022-03-01,2023-04,2023-04-30,2023-04,ESTIMATED,2023-04-30,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,AVENU,,Study of MRx0518 and Avelumab in Patients With Urothelial Carcinoma,A Phase 2 Switch Maintenance Study of MRx0518 and Avelumab in Patients With Unresectable Locally Advanced or Metastatic Urothelial Carcinoma Who Did Not Progress on First-Line Platinum-Containing Chemotherapy,WITHDRAWN,,PHASE2,0.0,ACTUAL,4D pharma plc,,1.0,,Sponsor unable to proceed,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,INDUSTRY,,,,,,,2023,0.0
NCT03715465,,2018-10-19,2022-10-31,,2022-10-31,2018-10-19,2018-10-23,ACTUAL,2022-10-31,2022-11-25,ACTUAL,,,,2022-10-31,2022-11-25,ACTUAL,2019-02-15,ACTUAL,2019-02-15,2022-10,2022-10-31,2021-11-05,ACTUAL,2021-11-05,2021-11-05,ACTUAL,2021-11-05,,INTERVENTIONAL,,,The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder,The Clinical Utility of DLMO in the Treatment of Delayed Sleep-Wake Phase Disorder: A Randomized Trial,COMPLETED,,PHASE3,44.0,ACTUAL,University of Michigan,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,OTHER,,,,,,,2021,1.0
NCT05572476,,2022-10-05,,,2024-06-04,2022-10-05,2022-10-07,ACTUAL,,,,,,,2024-06-04,2024-06-05,ACTUAL,2023-10,ESTIMATED,2023-10-31,2024-06,2024-06-30,2024-05-31,ACTUAL,2024-05-31,2024-05-31,ACTUAL,2024-05-31,,INTERVENTIONAL,LURBIMUNE,,Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer,Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,Institut Bergonié,,2.0,,"Recruitment difficulties, decline in the incidence of the studied pathology, active competitive clinical trials",f,,,,t,f,f,,,,,,,,,,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,OTHER,,,,,,,2024,0.0
NCT02724150,,2016-03-14,,,2018-07-07,2016-03-26,2016-03-31,ESTIMATED,,,,,,,2018-07-07,2018-07-10,ACTUAL,2017-12-01,ACTUAL,2017-12-01,2018-07,2018-07-31,2021-07,ESTIMATED,2021-07-31,2021-02,ESTIMATED,2021-02-28,,INTERVENTIONAL,,,Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding,Low Dose Against High Dose of Proton Pump Inhibitors in Treatment Acute Peptic Ulcer Bleeding,WITHDRAWN,,PHASE4,0.0,ACTUAL,Damascus Hospital,,2.0,,No participants enrolled,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,OTHER,,,,,,,2021,0.0
NCT04774250,,2021-02-23,,,2023-05-24,2021-02-25,2021-03-01,ACTUAL,,,,,,,2023-05-24,2023-05-26,ACTUAL,2021-11-10,ACTUAL,2021-11-10,2023-05,2023-05-31,2022-12-23,ACTUAL,2022-12-23,2022-12-23,ACTUAL,2022-12-23,,INTERVENTIONAL,PINIHL-AET,,Noise-Induced Hearing Loss-Acute Exposure Treatment (UA),Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment,TERMINATED,,PHASE2,38.0,ACTUAL,Washington University School of Medicine,,2.0,,Low accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:56:55.696496,2024-10-16 05:56:55.696496,OTHER,,,,,,,2022,0.0
NCT04794088,,2021-02-26,,,2023-01-19,2021-03-10,2021-03-11,ACTUAL,,,,,,,2023-01-19,2023-01-23,ACTUAL,2021-03-14,ACTUAL,2021-03-14,2023-01,2023-01-31,2022-04-07,ACTUAL,2022-04-07,2022-03-16,ACTUAL,2022-03-16,,INTERVENTIONAL,INVENT COVID,,Intravenous Imatinib in Mechanically Ventilated COVID-19 Patients,"A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of Intravenous Imatinib Mesylate (Impentri®) in Subjects With Acute Respiratory Distress Syndrome Induced by COVID-19",TERMINATED,,PHASE2,67.0,ACTUAL,"Amsterdam UMC, location VUmc",,2.0,,"Due to the decline of COVID-19 patients on Dutch ICUs. A sample size reestimation based on blinded study data of 66 patients was furthermore favorable, indicating sufficient power to detect a difference in primary endpoint between groups.",f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,OTHER,,,,,,,2022,0.0
NCT03566511,,2018-05-17,,,2023-06-02,2018-06-12,2018-06-25,ACTUAL,,,,,,,2023-06-02,2023-06-05,ACTUAL,2018-06-12,ACTUAL,2018-06-12,2023-06,2023-06-30,2024-08,ESTIMATED,2024-08-31,2024-08,ESTIMATED,2024-08-31,,INTERVENTIONAL,,,Use of Functional MRI to Assess Functional Hypothalamic Activation in Response to Diazoxide,Use of Functional MRI to Assess Functional Hypothalamic Activation in Response to Diazoxide,SUSPENDED,,PHASE2,24.0,ACTUAL,Albert Einstein College of Medicine,,4.0,,Temporarily paused while the MR center develops newer study techniques. We might resume; this is not a suspension of IRB approval.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,OTHER,,,,,,,2024,0.0
NCT02789878,,2016-05-25,,,2022-09-14,2016-06-02,2016-06-03,ESTIMATED,,,,,,,2022-09-14,2022-09-15,ACTUAL,2019-01-24,ACTUAL,2019-01-24,2022-09,2022-09-30,2022-08-01,ACTUAL,2022-08-01,2022-04-30,ACTUAL,2022-04-30,,INTERVENTIONAL,,,Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer,Phase II Study of Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for Patients With High-Risk Localized Prostate Cancer Prior to Radical Prostatectomy,COMPLETED,,PHASE2,64.0,ACTUAL,Instituto do Cancer do Estado de São Paulo,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,OTHER,,,,,,,2022,0.0
NCT03971071,,2019-05-23,2023-09-14,,2024-02-22,2019-05-31,2019-06-03,ACTUAL,2023-09-14,2023-10-13,ACTUAL,,,,2024-02-22,2024-03-20,ACTUAL,2019-10-07,ACTUAL,2019-10-07,2024-02,2024-02-29,2023-06-13,ACTUAL,2023-06-13,2022-12-01,ACTUAL,2022-12-01,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache,"A Phase 4, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Chronic Migraine and Medication Overuse Headache",COMPLETED,,PHASE4,620.0,ACTUAL,Amgen,,3.0,,,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,INDUSTRY,,,,,,,2023,1.0
NCT03098355,,2017-03-26,,,2024-03-14,2017-03-26,2017-03-31,ACTUAL,,,,,,,2024-03-14,2024-03-18,ACTUAL,2017-12-30,ACTUAL,2017-12-30,2022-09,2022-09-30,2023-12-31,ESTIMATED,2023-12-31,2022-12-15,ESTIMATED,2022-12-15,,INTERVENTIONAL,,,Interleukin-2 Following 4SCAR19/22 T Cells Targeting Refractory and/or Recurrent B Cell Malignancies,Anti-CD19/CD22 4th Generation CAR-T Cells (4SCAR19/22) Followed by Interleukin-2 Treating Pediatric Relapsed and Refractory B Cell Malignancies,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Zhujiang Hospital,,1.0,,The company did not offer the appropriate CART services.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,OTHER,,,,,,,2023,0.0
NCT04482712,,2020-07-21,,,2021-05-27,2020-07-21,2020-07-22,ACTUAL,,,,,,,2021-05-27,2021-06-01,ACTUAL,2021-04,ESTIMATED,2021-04-30,2021-05,2021-05-31,2023-01,ESTIMATED,2023-01-31,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,RAPA-CARDS,,Effects of mTOR Inhibition With Sirolimus (RAPA) in Patients With COVID-19 to Moderate the Progression of ARDS,Effects of mTOR Inhibition With Sirolimus (RAPA) in Patients With COVID-19 to Moderate the Progression of Acute Respiratory Distress Syndrome (RAPA-CARDS),WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,The University of Texas Health Science Center at San Antonio,,2.0,,"The study was never submitted to IRB or approved, due to feasibility issues",f,,,,t,t,f,,,,,,Data will become available at study completion at the time of journal publication.,,,YES,"All collected IPD, all IPD that underlie results in a publication will be shared.",2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,OTHER,,,,,,,2023,0.0
NCT04666675,,2020-12-08,,,2021-04-07,2020-12-08,2020-12-14,ACTUAL,,,,,,,2021-04-07,2021-04-08,ACTUAL,2020-12-24,ESTIMATED,2020-12-24,2021-04,2021-04-30,2021-03-23,ACTUAL,2021-03-23,2021-03-23,ACTUAL,2021-03-23,,INTERVENTIONAL,,,A Study of Oral Upadacitinib Tablets to Assess Change in Disease State in Participants Aged 12-75 Years With Moderate to Severe Atopic Dermatitis in Brazil,"A Phase 3b Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis in Brazil",WITHDRAWN,,PHASE3,0.0,ACTUAL,AbbVie,,4.0,,Strategic considerations,f,,,,t,t,f,,,t,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,INDUSTRY,,,,,,,2021,0.0
NCT04664959,,2020-12-10,,,2022-12-19,2020-12-10,2020-12-11,ACTUAL,,,,,,,2022-12-19,2022-12-20,ACTUAL,2020-11-26,ACTUAL,2020-11-26,2022-12,2022-12-31,2022-12-19,ACTUAL,2022-12-19,2022-06-20,ACTUAL,2022-06-20,,INTERVENTIONAL,,,A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis,"A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Between SB16 (Proposed Denosumab Biosimilar) and Prolia® in Postmenopausal Women With Osteoporosis",COMPLETED,,PHASE3,457.0,ACTUAL,"Samsung Bioepis Co., Ltd.",,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,INDUSTRY,,,,,,,2022,1.0
NCT04995094,,2021-07-19,,,2021-10-29,2021-08-02,2021-08-06,ACTUAL,,,,,,,2021-10-29,2021-11-05,ACTUAL,2021-08-15,ACTUAL,2021-08-15,2021-10,2021-10-31,2023-05-18,ESTIMATED,2023-05-18,2023-02-18,ESTIMATED,2023-02-18,,INTERVENTIONAL,,,"Study of Neoadjuvant Imprime PGG and Pembrolizumab for Stage III, Resectable Melanoma","A Phase II, Neoadjuvant, Randomized, Multicenter Study of Imprime PGG Plus Pembrolizumab in Subjects With Stage III, Resectable Melanoma",WITHDRAWN,,PHASE2,0.0,ACTUAL,"HiberCell, Inc.",,2.0,,"Enrollment challenges, study not feasible",f,,,,f,t,f,,,,,,,,,,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,INDUSTRY,,,,,,,2023,0.0
NCT04328480,,2020-03-30,,,2021-04-26,2020-03-30,2020-03-31,ACTUAL,,,,,,,2021-04-26,2021-04-27,ACTUAL,2020-04-17,ACTUAL,2020-04-17,2021-04,2021-04-30,2021-04-26,ACTUAL,2021-04-26,2021-04-25,ACTUAL,2021-04-25,,INTERVENTIONAL,COLCOVID,,The ECLA PHRI COLCOVID Trial. Effects of Colchicine on Moderate/High-risk Hospitalized COVID-19 Patients.,The ECLA PHRI COLCOVID Trial,COMPLETED,,PHASE3,1279.0,ACTUAL,Estudios Clínicos Latino América,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,OTHER,,,,,,,2021,0.0
NCT01891643,,2013-06-28,2021-06-02,,2021-06-29,2013-06-28,2013-07-03,ESTIMATED,2021-06-29,2021-07-01,ACTUAL,,,,2021-06-29,2021-07-01,ACTUAL,2013-09-30,ACTUAL,2013-09-30,2021-06,2021-06-30,2020-06-25,ACTUAL,2020-06-25,2020-06-25,ACTUAL,2020-06-25,,INTERVENTIONAL,,,PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy),"A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma",TERMINATED,,PHASE3,23.0,ACTUAL,Bristol-Myers Squibb,,2.0,,Insufficient enrollment,f,,,,f,,,,,,,,,,,,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,INDUSTRY,,,,,,,2020,0.0
NCT04269551,,2020-01-29,,,2022-04-25,2020-02-12,2020-02-17,ACTUAL,,,,,,,2022-04-25,2022-05-02,ACTUAL,2020-06-15,ACTUAL,2020-06-15,2022-04,2022-04-30,2022-01-06,ACTUAL,2022-01-06,2022-01-06,ACTUAL,2022-01-06,,INTERVENTIONAL,,,A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease,"A Multicenter, Phase 1b, Open Label, Nonrandomized, Single Dose Study Evaluating the Safety, Tolerability and Activity of BIVV020 in Adults With Cold Agglutinin Disease",COMPLETED,,PHASE1,12.0,ACTUAL,Sanofi,,1.0,,,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,INDUSTRY,,,,,,,2022,1.0
NCT03802227,,2018-11-15,2020-12-23,,2021-07-06,2019-01-10,2019-01-14,ACTUAL,2021-05-03,2021-05-27,ACTUAL,,,,2021-07-06,2021-07-08,ACTUAL,2018-10-22,ACTUAL,2018-10-22,2021-07,2021-07-31,2020-01-03,ACTUAL,2020-01-03,2019-12-17,ACTUAL,2019-12-17,,INTERVENTIONAL,,,"A Study Using fMRI Imaging to Evaluate the Effect of NKTR-181 on Brain Activity in Healthy, Non-physically Dependent Recreational Opioid Users.","A Phase 1 Double-Blind, Double-Dummy, Parallel-Group, Randomized, Positive Control Study Using fMRI to Evaluate the Effect of NKTR-181 on Brain Activity in Healthy, Non-physically Dependent Recreational Opioid Users",TERMINATED,,PHASE1,8.0,ACTUAL,Nektar Therapeutics,The study was originally planned for 24 patients. However enrollment was stopped due to the CDP being stopped at 8 and therefore limits the generalizability of this data.,2.0,,Sponsor Decision,f,,,,,t,f,,,,,,,,,,,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,INDUSTRY,,,,,,,2020,0.0
NCT03584009,,2018-06-25,2021-07-20,,2022-06-21,2018-07-10,2018-07-12,ACTUAL,2021-08-31,2021-09-27,ACTUAL,,,,2022-06-21,2022-06-28,ACTUAL,2018-09-06,ACTUAL,2018-09-06,2022-06,2022-06-30,2021-05-06,ACTUAL,2021-05-06,2020-08-05,ACTUAL,2020-08-05,,INTERVENTIONAL,Veronica,Intent-To-Treat (ITT) population included all randomized participants whether or not they were assigned to the arm where the study treatment was administered.,"A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy","A Phase II, Multicenter, Randomized Study To Compare The Efficacy Of Venetoclax Plus Fulvestrant Versus Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy",TERMINATED,,PHASE2,103.0,ACTUAL,Hoffmann-La Roche,"The study was terminated due to Sponsor's decision and there were no safety concerns. Primary and secondary efficacy endpoints have been updated to report 95% confidence interval (CI) for Clinical Benefit estimate and 95% CI for the Cox proportional hazards model for PFS, following reporting conventions.",2.0,,"Sponsor's decision, no safety concerns.",f,,,,,t,f,,,,,,,,,,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,INDUSTRY,,,,,,,2021,0.0
NCT04543409,,2020-08-18,2023-07-27,,2023-10-31,2020-09-04,2020-09-10,ACTUAL,2023-10-31,2023-11-18,ACTUAL,,,,2023-10-31,2023-11-18,ACTUAL,2020-09-22,ACTUAL,2020-09-22,2023-10,2023-10-31,2023-02-06,ACTUAL,2023-02-06,2022-09-19,ACTUAL,2022-09-19,,INTERVENTIONAL,MESSINA,All participants who were randomized and received any IP were included in the full analysis set.,A Study of Benralizumab in Patients With Eosinophilic Esophagitis,"A Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis",TERMINATED,,PHASE3,211.0,ACTUAL,AstraZeneca,,2.0,,"High-level results from the MESSINA Phase III trial showed that AstraZeneca's Fasenra (benralizumab) did not meet one of the two dual-primary endpoints. Given the lack of clear benefit in this patient population, study has been terminated.",f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,INDUSTRY,,,,,,,2023,0.0
NCT02562625,,2015-09-07,,,2020-04-07,2015-09-28,2015-09-29,ESTIMATED,,,,,,,2020-04-07,2020-04-09,ACTUAL,2016-02,ACTUAL,2016-02-29,2020-04,2020-04-30,2020-03,ACTUAL,2020-03-31,2020-03,ACTUAL,2020-03-31,,INTERVENTIONAL,PERM,,Trial of Pembrolizumab and Radiotherapy in Melanoma,Randomised Phase II Trial of Pembrolizumab and Radiotherapy in Melanoma,TERMINATED,,PHASE2,234.0,ESTIMATED,Royal Marsden NHS Foundation Trust,,2.0,,Slow Recruitment,f,,,,t,,,,,,,,,,,,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,OTHER,,,,,,,2020,0.0
NCT04378426,,2020-05-04,2022-11-02,,2023-03-01,2020-05-04,2020-05-07,ACTUAL,2023-03-01,2023-03-03,ACTUAL,,,,2023-03-01,2023-03-03,ACTUAL,2021-10-07,ACTUAL,2021-10-07,2023-03,2023-03-31,2022-08-31,ACTUAL,2022-08-31,2022-08-31,ACTUAL,2022-08-31,,INTERVENTIONAL,N2OP,Study discontinued due to unsufficient space due to backlog of clinical patients due to COVID,Nitrous Oxide for PTSD,Nitrous Oxide for Posttraumatic Stress Disorder (PTSD): A Phase IIa Trial,TERMINATED,,PHASE2,1.0,ACTUAL,VA Office of Research and Development,"The study was terminated in partnership with program officer given that the nitrous oxide administration space in the hospital (which had been used pre-pandemic) is longer available - it is being used exclusively for clinical care to keep up with the clinical backlog of cases due to the pandemic. This delay will continue for the foreseeable future. COVID-19 has had far-reaching impact on the feasibility of the study, which will not meet its recruitment goal in the foreseeable future.",2.0,,Use of VA hospital research space is indefinitely delayed due to prioritization of clinical cases delayed by COVID,f,,,,t,t,f,,,t,,,,,,NO,No data will be shared without approval of sponsor and IRB.,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,FED,,,,,,,2022,0.0
NCT02687269,,2016-02-10,,,2021-02-23,2016-02-16,2016-02-22,ESTIMATED,,,,,,,2021-02-23,2021-02-25,ACTUAL,2019-04-10,ESTIMATED,2019-04-10,2021-02,2021-02-28,2020-10,ESTIMATED,2020-10-31,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,Ranolazine a Potential New Therapeutic Application,Ranolazine Myocardial Protection in Complete Coronary Artery Bypass Grafting: A Randomized-controlled Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,Fondazione Policlinico Universitario Agostino Gemelli IRCCS,,2.0,,Inability to produce placebo tablets similar to the drug tested,f,,,,f,f,f,,,,,,,,,YES,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,OTHER,,,,,,,2020,0.0
NCT05490563,,2022-08-03,,,2024-04-22,2022-08-04,2022-08-05,ACTUAL,,,,,,,2024-04-22,2024-04-24,ACTUAL,2022-06-03,ACTUAL,2022-06-03,2024-04,2024-04-30,2023-11-24,ACTUAL,2023-11-24,2023-11-24,ACTUAL,2023-11-24,,INTERVENTIONAL,STRIDES,,STRIDES - a Clinical Research Study of an Investigational New Drug to Treat Spinocerebellar Ataxia,"A Double-blind, Randomized, Placebo Controlled, Trial to Assess Safety and Efficacy of SLS-005 (Trehalose Injection, 90.5 mg/mL for Intravenous Infusion) for the Treatment of Adults With Spinocerebellar Ataxia",TERMINATED,,PHASE2/PHASE3,23.0,ACTUAL,"Seelos Therapeutics, Inc.",,4.0,,"This was a business decision due to financial considerations, not based on data related to safety or therapeutic effects.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,INDUSTRY,,,,,,,2023,0.0
NCT04697056,,2020-12-23,2022-11-17,,2023-02-06,2021-01-04,2021-01-06,ACTUAL,2023-02-06,2023-03-02,ACTUAL,,,,2023-02-06,2023-03-02,ACTUAL,2021-01-25,ACTUAL,2021-01-25,2022-11,2022-11-30,2021-11-19,ACTUAL,2021-11-19,2021-11-19,ACTUAL,2021-11-19,,INTERVENTIONAL,,Intent-to-Treat (ITT) analysis set included all randomized participants.,A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Ichthyosis,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Subjects With Ichthyosis",TERMINATED,,PHASE2,5.0,ACTUAL,"AnaptysBio, Inc.","As a result of insufficient recruitment of participants, this study was terminated.",2.0,,Administrative Reason,f,,,,f,t,f,,,,,,,,,,,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,INDUSTRY,,,,,,,2021,0.0
NCT03232307,,2017-07-25,,,2019-08-20,2017-07-25,2017-07-27,ACTUAL,,,,,,,2019-08-20,2019-08-22,ACTUAL,2019-07-01,ESTIMATED,2019-07-01,2019-08,2019-08-31,2021-07-01,ESTIMATED,2021-07-01,2021-07-01,ESTIMATED,2021-07-01,,INTERVENTIONAL,,,Ibrutinib Plus Rituximab and Lenalidomide in Treating Elderly Participants With Newly Diagnosed Mantle Cell Lymphoma,A Phase II Study of Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed MCL,WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Sponsor does not wish to proceed,f,,,,t,t,f,,,,,,,,,,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,OTHER,,,,,,,2021,0.0
NCT04125719,,2019-10-11,,,2020-02-07,2019-10-11,2019-10-14,ACTUAL,,,,,,,2020-02-07,2020-02-11,ACTUAL,2020-06-01,ESTIMATED,2020-06-01,2020-02,2020-02-29,2024-10-01,ESTIMATED,2024-10-01,2024-10-01,ESTIMATED,2024-10-01,,INTERVENTIONAL,PPD1,,PVSRIPO in Combination With Nivolumab in Melanoma,A Phase IB Trial of PVSRIPO in Combination With Nivolumab in Patients With Recurrent PD-1 Refractory Melanoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,Duke University,,2.0,,resubmission planned,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2024,0.0
NCT04088032,,2019-09-10,,,2020-07-14,2019-09-11,2019-09-12,ACTUAL,,,,,,,2020-07-14,2020-07-16,ACTUAL,2019-10-01,ESTIMATED,2019-10-01,2020-07,2020-07-31,2020-12-31,ESTIMATED,2020-12-31,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,"Neoadjuvant Study of Abemaciclib, Durvalumab, and an Aromatase Inhibitor Early Stage Breast Cancer","A Pilot Neoadjuvant Clinical Trial of Combination Therapy With Abemaciclib, Durvalumab (MEDI4736), and an Aromatase Inhibitor in Locally Advanced Hormone Receptor Positive Breast Cancer",WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Stony Brook University,,1.0,,Per sponsor,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:03:23.937454,2024-10-15 18:03:23.937454,OTHER,,,,,,,2020,0.0
NCT03570697,,2018-06-18,2021-10-27,,2022-04-07,2018-06-18,2018-06-27,ACTUAL,2021-10-27,2021-11-24,ACTUAL,,,,2022-04-07,2022-05-03,ACTUAL,2018-11-19,ACTUAL,2018-11-19,2022-04,2022-04-30,2021-01-21,ACTUAL,2021-01-21,2020-12-18,ACTUAL,2020-12-18,,INTERVENTIONAL,,,Imaging of Coronary Plaques in Participants Treated With Evolocumab,High-Resolution Assessment of Coronary Plaques in a Global Evolocumab Randomized Study (HUYGENS),COMPLETED,,PHASE3,164.0,ACTUAL,Amgen,,2.0,,,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,INDUSTRY,,,,,,,2021,1.0
NCT00634231,,2008-03-05,,,2023-08-23,2008-03-05,2008-03-12,ESTIMATED,,,,,,,2023-08-23,2023-08-25,ACTUAL,2010-10,ACTUAL,2010-10-31,2023-08,2023-08-31,2021-06,ACTUAL,2021-06-30,2015-12,ACTUAL,2015-12-31,,INTERVENTIONAL,,,A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors,A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors,COMPLETED,,PHASE1,8.0,ACTUAL,"Candel Therapeutics, Inc.",,1.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,INDUSTRY,,,,,,,2021,1.0
NCT04460430,,2020-06-29,,,2022-10-24,2020-07-01,2020-07-07,ACTUAL,,,,,,,2022-10-24,2022-10-25,ACTUAL,2020-07-23,ACTUAL,2020-07-23,2022-10,2022-10-31,2021-11-29,ACTUAL,2021-11-29,2021-11-29,ACTUAL,2021-11-29,,INTERVENTIONAL,NEREA,,Targeting EGFR/ERBB2 With Neratinib in Hormone Receptor (HR)-Positive/HER2-negative HER2-enriched Advanced/Metastatic Breast Cancer,Targeting EGFR/ERBB2 With Neratinib in Hormone Receptor (HR)-Positive/HER2-negative HER2-enriched Advanced/Metastatic Breast Cancer,TERMINATED,,PHASE2,12.0,ACTUAL,SOLTI Breast Cancer Research Group,,1.0,,premature termination due to lack of funding,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,OTHER,,,,,,,2021,0.0
NCT03423355,,2017-12-18,,,2021-12-08,2018-01-31,2018-02-06,ACTUAL,,,,,,,2021-12-08,2021-12-15,ACTUAL,2021-09,ESTIMATED,2021-09-30,2021-07,2021-07-31,2023-12,ESTIMATED,2023-12-31,2023-03,ESTIMATED,2023-03-31,,INTERVENTIONAL,,,Dapagliflozin Effect on Erythropoiesis and Physical Fitness,"Dapagliflozin Effect on Erythropoiesis and Physical Fitness in Patients With Type 2 Diabetes - a Randomized, Partly Double-blinded, Controlled, Three Armed, Parallel Group, Exploratory Study",WITHDRAWN,,PHASE4,0.0,ACTUAL,University Hospital Tuebingen,,3.0,,change in sponsor,f,,,,f,f,f,,,t,,,,,,,,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,OTHER,,,,,,,2023,0.0
NCT02599402,,2015-11-05,2021-04-23,,2021-05-20,2015-11-05,2015-11-06,ESTIMATED,2021-05-20,2021-06-15,ACTUAL,,,,2021-05-20,2021-06-15,ACTUAL,2015-12-20,ACTUAL,2015-12-20,2021-05,2021-05-31,2020-02-10,ACTUAL,2020-02-10,2020-02-10,ACTUAL,2020-02-10,,INTERVENTIONAL,CheckMate 401,,Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma,Clinical Trial of Nivolumab (BMS-936558) Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Therapy of Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma CheckMate 401: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 401,COMPLETED,,PHASE3,533.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,INDUSTRY,,,,,,,2020,1.0
NCT02415257,,2015-01-26,,,2020-09-09,2015-04-08,2015-04-14,ESTIMATED,,,,,,,2020-09-09,2020-09-11,ACTUAL,2015-04,,2015-04-30,2020-09,2020-09-30,2020-09,ACTUAL,2020-09-30,2020-09,ACTUAL,2020-09-30,,INTERVENTIONAL,,,Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function,Gentamicin Treatment Prior to Vestibular Schwannoma Surgery in Patients With no Measurable Remaining Vestibular Function,WITHDRAWN,,PHASE4,0.0,ACTUAL,Lund University,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,OTHER,,,,,,,2020,0.0
NCT04128371,,2019-10-15,2023-09-28,,2024-03-21,2019-10-15,2019-10-16,ACTUAL,2024-03-21,2024-04-16,ACTUAL,,,,2024-03-21,2024-04-16,ACTUAL,2021-01-14,ACTUAL,2021-01-14,2022-11,2022-11-30,2022-10-31,ACTUAL,2022-10-31,2022-10-31,ACTUAL,2022-10-31,,INTERVENTIONAL,,,Mepolizumab in Episodic Angioedema With Eosinophilia,Pilot Study of Mepolizumab in Episodic Angioedema With Eosinophilia,TERMINATED,,PHASE2,5.0,ACTUAL,National Institutes of Health Clinical Center (CC),Study was closed due to futility,1.0,,Study was closed after the first five participants completed their participation due to lack of efficacy.,f,,,,,t,f,,,,,,,,,,,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,NIH,,,,,,,2022,0.0
NCT05191628,,2021-12-29,,,2023-04-28,2021-12-29,2022-01-13,ACTUAL,,,,,,,2023-04-28,2023-05-01,ACTUAL,2020-06-10,ACTUAL,2020-06-10,2023-04,2023-04-30,2022-10-10,ACTUAL,2022-10-10,2022-10-10,ACTUAL,2022-10-10,,INTERVENTIONAL,,,Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole,Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole,TERMINATED,,PHASE2,12.0,ACTUAL,TBF Genie Tissulaire,,1.0,,Low accrual rate,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,INDUSTRY,,,,,,,2022,0.0
NCT04357366,,2020-04-20,,,2023-07-12,2020-04-21,2020-04-22,ACTUAL,,,,,,,2023-07-12,2023-07-13,ACTUAL,2020-04-15,ACTUAL,2020-04-15,2023-07,2023-07-31,2022-04-15,ACTUAL,2022-04-15,2022-01-29,ACTUAL,2022-01-29,,INTERVENTIONAL,SAVE,,suPAR-guided Anakinra Treatment for Validation of the Risk and Management of Respiratory Failure by COVID-19 (SAVE),"suPAR-guided Anakinra Treatment for Validation of the Risk and Early Management of Severe Respiratory Failure by COVID-19: The SAVE Open-label, Non-randomized Single-arm Trial",COMPLETED,,PHASE2,1000.0,ACTUAL,Hellenic Institute for the Study of Sepsis,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,OTHER,,,,,,,2022,1.0
NCT04539873,,2020-08-29,,,2022-02-07,2020-09-04,2020-09-07,ACTUAL,,,,,,,2022-02-07,2022-02-23,ACTUAL,2021-04-30,ACTUAL,2021-04-30,2022-02,2022-02-28,2021-10-30,ACTUAL,2021-10-30,2021-10-30,ACTUAL,2021-10-30,,INTERVENTIONAL,(COLCOVID19),,Impact of Colchicine in Hospitalized Colombian Patients With COVID-19,Impact of Colchicine in Hospitalized Colombian Patients With COVID-19,TERMINATED,,PHASE3,128.0,ACTUAL,Fundación Universitaria de Ciencias de la Salud,,2.0,,non-inclusion of patients in the study effectively,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,OTHER,,,,,,,2021,0.0
NCT03495713,,2018-04-05,2023-06-07,,2023-12-21,2018-04-05,2018-04-12,ACTUAL,2023-06-07,2023-06-28,ACTUAL,,,,2023-12-21,2024-01-17,ACTUAL,2018-11-02,ACTUAL,2018-11-02,2023-12,2023-12-31,2022-04-20,ACTUAL,2022-04-20,2022-04-20,ACTUAL,2022-04-20,,INTERVENTIONAL,,,Lymphoma RadVax LYMPHOMA: A PHASE II TRIAL OF NIVOLUMAB + LOW DOSE RADIOTHERAPY FOR INCOMPLETE RESPONDERS,RadVax for Relapsed/Refractory Hodgkin's Lymphoma: A Phase II Trial of Nivolumab + Low Dose Radiotherapy for Incomplete Responders,TERMINATED,,PHASE2,7.0,ACTUAL,Abramson Cancer Center at Penn Medicine,,1.0,,Covid-19,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,OTHER,,,,,,,2022,0.0
NCT04287478,,2020-02-03,,,2023-03-01,2020-02-26,2020-02-27,ACTUAL,,,,,,,2023-03-01,2023-03-03,ACTUAL,2020-12-09,ACTUAL,2020-12-09,2023-03,2023-03-31,2023-02-28,ACTUAL,2023-02-28,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,,,Bacteriophage Therapy in Patients With Urinary Tract Infections,"A Phase I/II Study of Bacteriophage Therapy to Evaluate Safety, Tolerability, and Efficacy of Targeted Personalized Bacteriophage Treatments in Patients With Bacterial Infection of the Urinary Tract",TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,"Adaptive Phage Therapeutics, Inc.",,6.0,,Study terminated due to a change in development strategy.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 17:57:15.52547,2024-10-15 17:57:15.52547,INDUSTRY,,,,,,,2023,0.0
NCT05372809,,2022-05-06,,,2024-02-22,2022-05-09,2022-05-13,ACTUAL,,,,,,,2024-02-22,2024-02-26,ACTUAL,2022-04-28,ACTUAL,2022-04-28,2024-02,2024-02-29,2024-02-21,ACTUAL,2024-02-21,2024-02-21,ACTUAL,2024-02-21,,INTERVENTIONAL,COVER DFUs,,"Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® in the Treatment of Wagner 2 DFUs",Closure Obtained With Vascularized Epithelial Regeneration for DFUs With SkinTE®,TERMINATED,,PHASE3,42.0,ACTUAL,PolarityTE,,2.0,,Study terminated due to slow enrollment and change in strategy.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,INDUSTRY,,,,,,,2024,0.0
NCT03551522,,2018-05-09,2022-04-05,,2022-08-30,2018-06-07,2018-06-11,ACTUAL,2022-07-01,2022-07-05,ACTUAL,,,,2022-08-30,2022-09-15,ACTUAL,2018-04-30,ACTUAL,2018-04-30,2022-07,2022-07-31,2020-08-10,ACTUAL,2020-08-10,2019-05-08,ACTUAL,2019-05-08,,INTERVENTIONAL,,,A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH),"A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Followed by an Open-Label Extension Period to Evaluate the Activity of Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)",TERMINATED,,PHASE2,181.0,ACTUAL,Gilead Sciences,,4.0,,unexpected histological findings,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,INDUSTRY,,,,,,,2020,0.0
NCT04354428,,2020-04-16,2021-11-16,,2022-07-12,2020-04-16,2020-04-21,ACTUAL,2022-07-12,2022-08-08,ACTUAL,,,,2022-07-12,2022-08-08,ACTUAL,2020-04-16,ACTUAL,2020-04-16,2022-07,2022-07-31,2020-11-30,ACTUAL,2020-11-30,2020-11-03,ACTUAL,2020-11-03,,INTERVENTIONAL,,,Treatment for COVID-19 in High-Risk Adult Outpatients,Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults: An Adaptive Randomized Platform Trial,TERMINATED,,PHASE2/PHASE3,289.0,ACTUAL,University of Washington,Early termination of HCQ and HCQ/AZ arms as well as lopinavir-ritonavir arms leading to small numbers of participants analyzed.,5.0,,Low number of events contributing to primary outcome,f,,,,t,t,f,,,f,,,Within 3 months of publication of primary results.,De-identified data from the study will be made available in accordance with the funder's open access policy.,https://www.gatesfoundation.org/how-we-work/general-information/open-access-policy,YES,De-identified data from the study will be made available in accordance with the funder's open access policy.,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,OTHER,,,,,,,2020,0.0
NCT03637764,,2018-08-05,2023-05-10,,2023-07-06,2018-08-16,2018-08-20,ACTUAL,2023-05-10,2023-06-08,ACTUAL,,,,2023-07-06,2023-07-10,ACTUAL,2018-08-06,ACTUAL,2018-08-06,2023-05,2023-05-31,2022-05-11,ACTUAL,2022-05-11,2022-05-11,ACTUAL,2022-05-11,,INTERVENTIONAL,,"Analysis was performed on all-treated population that included all the participants who signed the study informed consent and received at least 1 dose of the study treatments, either isatuximab or atezolizumab.","Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies","A Phase 1/2 Open-label, Multi-center, Safety, Preliminary Efficacy and Pharmacokinetic (PK) Study of Isatuximab (SAR650984) in Combination With Atezolizumab or Isatuximab Alone in Patients With Advanced Malignancies",TERMINATED,,PHASE1/PHASE2,107.0,ACTUAL,Sanofi,"Study was stopped after performance of interim analysis for 4 cohorts (Cohort A \[HCC\], Cohort B \[SCCHN\], Cohort C \[EOC\] \& Cohort D-1 \[GBM\]) as the efficacy results observed in each cohort did not fulfill the pre-planned interim analysis criteria allowing the study to move to Phase 2 Stage 2 in these 4 cohorts.",4.0,,"Study was stopped after interim analysis for 4 cohorts (HCC, SCCHN, EOC, and GBM) indicated that the results did not fulfill the preplanned interim analysis criteria to move to Phase 2 stage 2 in all 4 cohorts.",f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,INDUSTRY,,,,,,,2022,0.0
NCT06091579,,2023-10-16,,,2023-10-16,2023-10-16,2023-10-19,ACTUAL,,,,,,,2023-10-16,2023-10-19,ACTUAL,2020-09-17,ACTUAL,2020-09-17,2023-10,2023-10-31,2021-01-12,ACTUAL,2021-01-12,2021-01-12,ACTUAL,2021-01-12,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder (TPIP) in Healthy Participants","A Phase 1, Randomized, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, And Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Healthy Volunteers",COMPLETED,,PHASE1,42.0,ACTUAL,Insmed Incorporated,,5.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,INDUSTRY,,,,,,,2021,1.0
NCT02913612,,2016-08-12,2022-10-20,2020-10-06,2024-03-10,2016-09-21,2016-09-26,ESTIMATED,2022-10-20,2022-11-15,ACTUAL,2020-10-06,2020-10-19,ACTUAL,2024-03-10,2024-03-12,ACTUAL,2017-05-05,ACTUAL,2017-05-05,2024-03,2024-03-31,2020-10-20,ACTUAL,2020-10-20,2020-10-20,ACTUAL,2020-10-20,,INTERVENTIONAL,TIM01,,"Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH)","Efficacy, Safety, and Pharmacokinetics of Timolol in Infants With Infantile Hemangioma (IH)",COMPLETED,,PHASE2,105.0,ACTUAL,Duke University,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,OTHER,,,,,,,2020,1.0
NCT04418219,,2020-03-16,,,2021-06-03,2020-06-03,2020-06-05,ACTUAL,,,,,,,2021-06-03,2021-06-07,ACTUAL,2020-12-21,ESTIMATED,2020-12-21,2021-06,2021-06-30,2024-01-01,ESTIMATED,2024-01-01,2023-01-01,ESTIMATED,2023-01-01,,INTERVENTIONAL,,,"Breast Cancer Vaccine in Combination With Pembrolizumab for Treatment of Persistent, Recurrent, or Metastatic Breast Cancer",A Phase I/II Study of the SV-BR-1-GM Regimen in HLA Matched Metastatic Breast Cancer Patients in Combination With Pembrolizumab,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Thomas Jefferson University,,1.0,,Funding Discontinued,f,,,,t,t,f,,,,,,,,,,,2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,OTHER,,,,,,,2024,0.0
NCT03029442,,2017-01-20,,,2024-03-13,2017-01-20,2017-01-24,ESTIMATED,,,,,,,2024-03-13,2024-03-15,ACTUAL,2017-04-01,ACTUAL,2017-04-01,2024-03,2024-03-31,2022-10-06,ACTUAL,2022-10-06,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury,The Efficacy of Denosumab to Prevent Bone Loss in Ambulatory and Non-ambulatory Motor-Incomplete Patients With Subacute Spinal Cord Injury,TERMINATED,,PHASE4,5.0,ACTUAL,James J. Peters Veterans Affairs Medical Center,,4.0,,Study ended early due to COVID-19,f,,,,t,t,f,,,,,,,,,NO,An IPD is not desired by the investigators and is not part of the regulatory guidelines at the participating institutions,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,FED,,,,,,,2022,0.0
NCT05623839,,2022-11-15,,,2023-07-01,2022-11-15,2022-11-21,ACTUAL,,,,,,,2023-07-01,2023-07-05,ACTUAL,2022-11-16,ACTUAL,2022-11-16,2023-07,2023-07-31,2023-06-27,ACTUAL,2023-06-27,2023-06-27,ACTUAL,2023-06-27,,INTERVENTIONAL,,,A Study of LY3305677 in Participants With Obesity Or Overweight,"A Multiple Dose Titration Study in Participants With Obesity or Overweight to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677",COMPLETED,,PHASE1,32.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 08:03:17.048761,2024-10-15 08:03:17.048761,INDUSTRY,,,,,,,2023,1.0
NCT05068856,,2021-09-15,,,2024-07-16,2021-09-25,2021-10-06,ACTUAL,,,,,,,2024-07-16,2024-07-18,ACTUAL,2021-12-28,ACTUAL,2021-12-28,2024-07,2024-07-31,2024-05-15,ACTUAL,2024-05-15,2024-05-15,ACTUAL,2024-05-15,,INTERVENTIONAL,,,A Study of HRS2543 in Patients With Advanced Tumors,"A Phase I, Multi-Center, Open Label, Dose Escalation/Expansion Study of HRS2543 in Patients With Advanced Tumors",TERMINATED,,PHASE1,10.0,ACTUAL,"Shanghai Hengrui Pharmaceutical Co., Ltd.",,1.0,,R\&d strategy adjustment,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,INDUSTRY,,,,,,,2024,0.0
NCT03537612,,2018-05-15,,,2023-11-20,2018-05-15,2018-05-25,ACTUAL,,,,,,,2023-11-20,2023-11-22,ACTUAL,2018-06-22,ACTUAL,2018-06-22,2023-11,2023-11-30,2022-04-05,ACTUAL,2022-04-05,2022-04-05,ACTUAL,2022-04-05,,INTERVENTIONAL,RCT,,Sensorial and Physiological Mechanism-based Assessments of Perioperative Pain,Sensorial and Physiological Mechanism-based Assessments of Perioperative Pain,TERMINATED,,PHASE3,15.0,ACTUAL,Shriners Hospitals for Children,,4.0,,Do to our inability to meet recruitment targets - Sponsor stopped funding. Looking for new sponsor and protocol modifications,f,,,,t,f,f,,,,,,,,,,,2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,OTHER,,,,,,,2022,0.0
NCT02595996,,2015-09-18,2021-09-24,,2021-09-24,2015-11-02,2015-11-04,ESTIMATED,2021-09-24,2021-10-22,ACTUAL,,,,2021-09-24,2021-10-22,ACTUAL,2017-06-07,ACTUAL,2017-06-07,2021-09,2021-09-30,2020-10-08,ACTUAL,2020-10-08,2020-10-08,ACTUAL,2020-10-08,,INTERVENTIONAL,,,Propranolol Dose Escalation in Lymphedema in Patients,An Intra-patient Dose Escalation Study of Propranolol in Patients With Lymphedema,TERMINATED,,PHASE2,1.0,ACTUAL,Columbia University,Study terminated due to lack of funding. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).,1.0,,Lack of funding,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,OTHER,,,,,,,2020,0.0
NCT03963973,,2019-05-23,,,2020-02-19,2019-05-24,2019-05-28,ACTUAL,,,,,,,2020-02-19,2020-02-20,ACTUAL,2019-05-16,ACTUAL,2019-05-16,2020-02,2020-02-29,2020-01-22,ACTUAL,2020-01-22,2020-01-22,ACTUAL,2020-01-22,,INTERVENTIONAL,,,A 28 Day Parallel Group Study to Assess the Effects of RDN-929,"A Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetic (PK) Profile of Multiple Oral Doses of RDN-929 in Healthy Older Adults",TERMINATED,,PHASE1,7.0,ACTUAL,"Alkermes, Inc.",,2.0,,Participants no longer receiving intervention,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,INDUSTRY,,,,,,,2020,0.0
NCT04441671,,2020-01-20,,,2021-04-21,2020-06-18,2020-06-22,ACTUAL,,,,,,,2021-04-21,2021-04-22,ACTUAL,2020-12-08,ACTUAL,2020-12-08,2021-04,2021-04-30,2021-04-01,ACTUAL,2021-04-01,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,,,Oral Pyrophosphate Absorption in PXE Disease,Oral Disodiumpyrophosphate (Na2H2PPi) Absorption in Pseudoxanthoma Elasticum (PXE),WITHDRAWN,,PHASE2,0.0,ACTUAL,Tampere University Hospital,,1.0,,Withdrawn,f,,,,f,f,f,,,,,,,,,NO,Only anonymized data can be shared,2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,OTHER,,,,,,,2021,0.0
NCT04432272,,2020-06-12,2021-11-12,,2022-03-07,2020-06-12,2020-06-16,ACTUAL,2021-11-12,2021-11-22,ACTUAL,,,,2022-03-07,2022-03-09,ACTUAL,2020-07-16,ACTUAL,2020-07-16,2022-03,2022-03-31,2020-11-28,ACTUAL,2020-11-28,2020-11-13,ACTUAL,2020-11-13,,INTERVENTIONAL,ABACCuS,,ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS),ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS),TERMINATED,,PHASE2,71.0,ACTUAL,William Beaumont Hospitals,"Early termination due to changes in the Emergency Use Authorization for plasma during COVID-19. All plasma was labeled either low titer or high titer. The protocol required untitered plasma be used, which resulted in inability to complete the study and early termination.",2.0,,"The EUA for CCP was updated by FDA, stipulating that only high titer units be used. This study required untitered units. The study became infeasible",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,OTHER,,,,,,,2020,0.0
NCT04447417,,2020-06-22,2022-06-14,,2022-07-19,2020-06-22,2020-06-25,ACTUAL,2022-07-19,2022-07-22,ACTUAL,,,,2022-07-19,2022-07-22,ACTUAL,2020-07-16,ACTUAL,2020-07-16,2022-07,2022-07-31,2021-06-17,ACTUAL,2021-06-17,2021-06-17,ACTUAL,2021-06-17,,INTERVENTIONAL,BALISTAD,Analysis was performed on safety population: all enrolled participants who actually received at least one dose of investigational medicinal product (IMP) or had at least one transepidermal water loss (TEWL)/skin tape stripping (STS) assessment and all healthy volunteers who had at least one TEWL/STS assessment performed.,Dupilumab Skin Barrier Function Study in Atopic Dermatitis,Open Label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier Function in Patients With Moderate to Severe Atopic Dermatitis,COMPLETED,,PHASE4,52.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.",2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,INDUSTRY,,,,,,,2021,1.0
NCT03347188,,2017-11-14,2021-02-22,,2022-12-09,2017-11-16,2017-11-20,ACTUAL,2021-03-25,2021-03-26,ACTUAL,,,,2022-12-09,2022-12-13,ACTUAL,2017-12-18,ACTUAL,2017-12-18,2022-12,2022-12-31,2020-06-03,ACTUAL,2020-06-03,2020-03-13,ACTUAL,2020-03-13,,INTERVENTIONAL,,Intent-to-treat (ITT) analysis set included all randomized participants.,A Study to Test if Fremanezumab Reduces Headache in Participants With Posttraumatic Headache (PTH),"A Phase 2, Multicenter, Randomized, Proof-of-Concept, Double-Blind, Placebo-Controlled, Parallel-Group Study, Including an Open-Label Period, Evaluating the Efficacy and Safety of 1 Subcutaneous Dose Regimen of Fremanezumab for the Treatment of Posttraumatic Headache (PTH)",COMPLETED,,PHASE2,87.0,ACTUAL,"Teva Branded Pharmaceutical Products R&D, Inc.",,2.0,,,t,,,,f,t,f,,,,,,,,,NO,,2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,INDUSTRY,,NCT03539393,AVAILABLE,,,,2020,1.0
NCT02770170,,2016-05-11,2021-06-18,,2021-06-18,2016-05-11,2016-05-12,ESTIMATED,2021-06-18,2021-07-12,ACTUAL,,,,2021-06-18,2021-07-12,ACTUAL,2016-05-16,ACTUAL,2016-05-16,2021-06,2021-06-30,2020-08-18,ACTUAL,2020-08-18,2020-06-23,ACTUAL,2020-06-23,,INTERVENTIONAL,,Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.,"Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis","A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Effect of BI 655064 Administered as Sub-cutaneous Injections, on Renal Response After One Year of Treatment, in Patients With Active Lupus Nephritis",COMPLETED,,PHASE2,121.0,ACTUAL,Boehringer Ingelheim,,4.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,INDUSTRY,,,,,,,2020,1.0
NCT04996056,,2021-08-03,,,2022-06-23,2021-08-03,2021-08-09,ACTUAL,,,,,,,2022-06-23,2022-06-29,ACTUAL,2021-09-03,ACTUAL,2021-09-03,2022-06,2022-06-30,2022-06-16,ACTUAL,2022-06-16,2022-06-16,ACTUAL,2022-06-16,,INTERVENTIONAL,,,"An Open-Label, Randomized Pilot Study Comparing the Safety of a Single Dose of TNX-1300 to Usual Care (UC) Alone for the Treatment of Signs and Symptoms of Acute Cocaine Intoxication in Male Emergency Department (ED) Subjects","An Open-Label, Randomized Pilot Study Comparing the Safety of a Single Dose of TNX-1300 to Usual Care (UC) Alone for the Treatment of Signs and Symptoms of Acute Cocaine Intoxication in Male Emergency Department (ED) Subjects",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Tonix Pharmaceuticals, Inc.",,2.0,,Not able to recruit qualified participants,f,,,,f,t,f,,,,,,,,,,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,INDUSTRY,,,,,,,2022,0.0
NCT02770807,,2016-05-02,2023-12-22,,2024-05-09,2016-05-10,2016-05-12,ESTIMATED,2024-04-15,2024-05-09,ACTUAL,,,,2024-05-09,2024-05-10,ACTUAL,2017-03-02,ACTUAL,2017-03-02,2024-05,2024-05-31,2021-05-13,ACTUAL,2021-05-13,2021-05-13,ACTUAL,2021-05-13,,INTERVENTIONAL,ATTeST,"Safety (SAF): all patients who received any amount of randomized treatment (also referred to as the ITT ) Full Analysis Set (FAS): All randomized pts who received at least 1 dose of study medication and had at least one post-baseline efficacy assessment of the primary efficacy variable (also referred to as mITT ) Per Protocol (PP): all pts enrolled fulfilled all Inclusion/Exclusion criteria, did not have any major protocol violations, and completed the Initial Treatment Period of the study",Intra-Erythrocyte Dexamethasone Sodium Phosphate in Ataxia Telangiectasia Patients,"Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Intra-Erythrocyte Dexamethasone Sodium Phosphate on Neurological Symptoms in Patients With Ataxia Telangiectasia",COMPLETED,,PHASE3,176.0,ACTUAL,Quince Therapeutics S.p.A.,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,INDUSTRY,,,,,,,2021,1.0
NCT03866200,,2019-03-05,2022-11-18,2021-11-16,2022-11-18,2019-03-05,2019-03-07,ACTUAL,2022-11-18,2022-12-09,ACTUAL,2021-11-16,2021-11-19,ACTUAL,2022-11-18,2022-12-09,ACTUAL,2019-06-29,ACTUAL,2019-06-29,2022-11,2022-11-30,2020-10-28,ACTUAL,2020-10-28,2020-10-28,ACTUAL,2020-10-28,,INTERVENTIONAL,,,Resveratrol Trial for Relief of Pain in Pseudoachondroplasia,Resveratrol Trial for Relief of Pain in Pseudoachondroplasia,TERMINATED,,PHASE2,6.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,Inability to recruit target number,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,OTHER,,,,,,,2020,0.0
NCT03271229,,2017-08-31,,,2019-12-22,2017-08-31,2017-09-05,ACTUAL,,,,,,,2019-12-22,2019-12-24,ACTUAL,2019-09,ESTIMATED,2019-09-30,2019-12,2019-12-31,2021-01,ESTIMATED,2021-01-31,2021-01,ESTIMATED,2021-01-31,,INTERVENTIONAL,,,Conventional Platelet-Rich Plasma Versus Concentrated Bone Marrow Stem Cell Injections for Osteoarthritis of the Knee,"A Randomized, Single-Blinded, Controlled Trial Comparing Conventional Platelet Rich Plasma (PRP) to Concentrated Bone Marrow Aspirate (BMAC) for Osteoarthritis of the Knee",WITHDRAWN,,PHASE2,0.0,ACTUAL,Mayo Clinic,,2.0,,Funding,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,OTHER,,,,,,,2021,0.0
NCT03917459,,2019-04-09,2022-05-19,,2024-02-27,2019-04-15,2019-04-17,ACTUAL,2023-04-18,2024-01-08,ACTUAL,,,,2024-02-27,2024-02-29,ACTUAL,2019-04-16,ACTUAL,2019-04-16,2024-02,2024-02-29,2021-05-25,ACTUAL,2021-05-25,2021-05-25,ACTUAL,2021-05-25,,INTERVENTIONAL,CONFIDENCE-HF,A total of 27 patients were included in the Full Analysis Set (FAS) and safety set.,COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure,"A Randomized, Double-blind, Active-controlled Study to Assess the Effect of Sacubitril/Valsartan Compared With Enalapril to Improve Erectile Function in Patients With Heart Failure With Reduced Ejection Fraction and Erectile Dysfunction",COMPLETED,,PHASE3,27.0,ACTUAL,Novartis,,2.0,,,f,,,,f,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,INDUSTRY,,,,,,,2021,1.0
NCT03124459,,2017-04-12,2021-03-11,,2022-09-13,2017-04-20,2017-04-21,ACTUAL,2021-07-08,2021-07-28,ACTUAL,,,,2022-09-13,2022-09-26,ACTUAL,2017-07-31,ACTUAL,2017-07-31,2022-09,2022-09-30,2020-03-11,ACTUAL,2020-03-11,2020-03-11,ACTUAL,2020-03-11,,INTERVENTIONAL,,"The Full Analysis Set includes all randomized patients who have received at least 1 dose of study drug (includes placebo). Additionally, the participants in the Open-Label portion of Part 2 are a sub-set of the participants that enrolled and then subsequently completed the double-blind placebo controlled portion of Part 2. The open-label baseline measures are captured separately.",Study of ACE-083 in Patients With Charcot-Marie-Tooth Disease,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ACE-083 in Patients With Charcot-Marie-Tooth Disease Types 1 and X",TERMINATED,,PHASE2,63.0,ACTUAL,"Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA",The study was terminated because the statistically significant increase in total muscle volume (TMV) failed to translate to statistically significant improvements in functional or disease-related quality of life secondary endpoints in the study.,5.0,,(Investigation of ACE-083 for use in patients with CMT is being discontinued as it did not achieve functional secondary endpoints in the A083-03 trial.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,INDUSTRY,,,,,,,2020,0.0
NCT03987750,,2019-06-12,,,2020-06-15,2019-06-14,2019-06-17,ACTUAL,,,,,,,2020-06-15,2020-06-17,ACTUAL,2019-10,ESTIMATED,2019-10-31,2019-06,2019-06-30,2021-05,ESTIMATED,2021-05-31,2021-04,ESTIMATED,2021-04-30,,INTERVENTIONAL,,,Safinamide for Levodopa-induced Dyskinesia (PD-LID),"A Phase 3, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of 2 Doses of Safinamide Compared to Placebo in the Treatment of LID in PD Patients With Motor Fluctuations",WITHDRAWN,,PHASE3,0.0,ACTUAL,Zambon SpA,,3.0,,drug development plan has been updated,,,,,f,t,f,,,,,,,,,,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,INDUSTRY,,,,,,,2021,0.0
NCT02378623,,2015-02-27,,,2018-11-15,2015-03-03,2015-03-04,ESTIMATED,,,,,,,2018-11-15,2018-11-16,ACTUAL,2015-05,,2015-05-31,2018-11,2018-11-30,2020-01,ESTIMATED,2020-01-31,2020-01,ESTIMATED,2020-01-31,,INTERVENTIONAL,PARADOX,,Patients With Patent Foramen Ovale and Endocardial Device Leads on Apixaban for Prevention of Paradoxical Emboli,"PARADOX Trial: A Prospective, Double-Blind, Randomized Controlled Trial in Patients With Patent Foramen Ovale and Endocardial Device Leads on Apixaban for Prevention of Paradoxical Emboli",WITHDRAWN,,PHASE2,0.0,ACTUAL,Mayo Clinic,,2.0,,Sponsor withdrew funding - May 2016,f,,,,t,,,,,,,,,,,,,2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,OTHER,,,,,,,2020,0.0
NCT03593213,,2018-07-10,2022-02-10,,2022-04-07,2018-07-10,2018-07-20,ACTUAL,2022-02-10,2022-03-08,ACTUAL,,,,2022-04-07,2022-04-11,ACTUAL,2018-07-30,ACTUAL,2018-07-30,2022-04,2022-04-30,2021-02-11,ACTUAL,2021-02-11,2021-02-11,ACTUAL,2021-02-11,,INTERVENTIONAL,,Double-blind Safety Population included all participants who took at least 1 dose of cariprazine during and double-blind treatment period.,"Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia","A Double-Blind, Placebo-Controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients With Schizophrenia",TERMINATED,,PHASE3,587.0,ACTUAL,AbbVie,,4.0,,FDA Released Allergan from this post marketing requirement,f,,,,f,t,f,,,,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 18:03:23.937454,2024-10-15 18:03:23.937454,INDUSTRY,,,,,,,2021,0.0
NCT03090412,,2017-03-20,2022-05-06,,2022-05-06,2017-03-20,2017-03-24,ACTUAL,2022-05-06,2022-06-02,ACTUAL,,,,2022-05-06,2022-06-02,ACTUAL,2018-03-07,ACTUAL,2018-03-07,2022-05,2022-05-31,2021-08-06,ACTUAL,2021-08-06,2021-08-01,ACTUAL,2021-08-01,,INTERVENTIONAL,,,Photodynamic Therapy With HPPH Compared to Standard of Care Surgery in Treating Patients With Oral Cavity Cancer,A Randomized Multicenter Phase II Study Using (2-1[Heyloxyethyl]-2-Devinylpyropheophorbide-a) (HPPH) With PDT Versus Standard of Care Surgery for Patients With T1/T2 N0 Squamous Cell Carcinoma of the Oral Cavity,TERMINATED,,PHASE2,2.0,ACTUAL,Roswell Park Cancer Institute,,2.0,,low accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,OTHER,,,,,,,2021,0.0
NCT04676412,,2020-12-15,2022-10-14,2022-03-17,2024-07-23,2020-12-15,2020-12-21,ACTUAL,2022-10-14,2022-11-09,ACTUAL,2022-03-17,2022-04-18,ACTUAL,2024-07-23,2024-08-01,ACTUAL,2019-10-23,ACTUAL,2019-10-23,2024-07,2024-07-31,2024-03-29,ACTUAL,2024-03-29,2021-05-19,ACTUAL,2021-05-19,,INTERVENTIONAL,LEAP-007,All Chinese participants who were randomized to the global study (NCT03829332) or to the extension portion.,Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) [MK-7902-007/E7080-G000-314/LEAP-007] - China Extension Study,"A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Nonsmall Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)",COMPLETED,,PHASE3,27.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,t,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,INDUSTRY,,,,,,,2024,1.0
NCT04425655,,2020-06-03,,,2022-09-19,2020-06-06,2020-06-11,ACTUAL,,,,,,,2022-09-19,2022-09-22,ACTUAL,2020-08-05,ACTUAL,2020-08-05,2022-09,2022-09-30,2022-07-01,ACTUAL,2022-07-01,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,,,Fludarabine in Combination With Daunorubicin and Cytarabine Liposome in Newly-diagnosed Acute Myeloid Leukemia.,A Phase II Trial of Fludarabine in Combination With Daunorubicin and Cytarabine Liposome for Adults With Newly-diagnosed Acute Myeloid Leukemia: University of California Hematologic Malignancies Consortium Protocol 1914,TERMINATED,,PHASE2,2.0,ACTUAL,"University of California, San Diego",,1.0,,Original investigator for the trial has left,f,,,,t,t,f,,,,,,,,,,,2024-10-16 06:02:25.862364,2024-10-16 06:02:25.862364,OTHER,,,,,,,2022,0.0
NCT04034615,,2019-07-24,,,2022-12-19,2019-07-24,2019-07-26,ACTUAL,,,,,,,2022-12-19,2022-12-21,ACTUAL,2021-05-20,ACTUAL,2021-05-20,2022-12,2022-12-31,2022-06-01,ESTIMATED,2022-06-01,2021-12-01,ESTIMATED,2021-12-01,,INTERVENTIONAL,,,The Long-term Effect of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars,"A Phase II, Randomized, Placebo-Controlled Study of the Long-term Efficacy of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars",WITHDRAWN,,PHASE2,0.0,ACTUAL,Maternal and Child Health Hospital of Foshan,,3.0,,The pandemic resulted in no enrollments。,f,,,,t,f,f,,,,,,,,,,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,OTHER,,,,,,,2022,0.0
NCT03906136,,2019-03-26,,,2023-07-06,2019-04-04,2019-04-08,ACTUAL,,,,,,,2023-07-06,2023-07-10,ACTUAL,2019-06-04,ACTUAL,2019-06-04,2023-07,2023-07-31,2022-09-22,ACTUAL,2022-09-22,2022-02-04,ACTUAL,2022-02-04,,INTERVENTIONAL,AScalate,,AScalate: Treat-to-target in Axial Spondyloarthritis,"A Randomized, Open Label Multicenter Trial to Investigate the Efficacy of a Treat-to-target (T2T) Treatment Strategy With Secukinumab (AIN457) as a First-line Biologic Compared to a Standard-of-care (SOC) Treatment Over 36 Weeks in Patients With Active Axial Spondyloarthritis (axSpA)",COMPLETED,,PHASE3,305.0,ACTUAL,Novartis,,2.0,,,f,,,,t,f,f,,,,,,,,,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,INDUSTRY,,,,,,,2022,0.0
NCT04561180,,2020-09-22,,,2023-07-26,2020-09-22,2020-09-23,ACTUAL,,,,,,,2023-07-26,2023-07-28,ACTUAL,2022-03-04,ACTUAL,2022-03-04,2023-07,2023-07-31,2023-05-01,ACTUAL,2023-05-01,2023-05-01,ACTUAL,2023-05-01,,INTERVENTIONAL,,,Study to Evaluate the Efficacy and Safety of EG-009A Compared to DEX in Patients With COVID-19 Pneumonia,"A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of EG-009A Compared to Dexamethasone in Patients With Moderate/Severe (Non-intubated, Non-mechanical Ventilation) COVID-19 Pneumonia",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Evergreen Therapeutics, Inc.",,3.0,,No patients COVID-19 morbidity decreased.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,INDUSTRY,,,,,,,2023,0.0
NCT03511664,,2018-04-13,2022-04-12,2021-12-01,2024-07-09,2018-04-26,2018-04-30,ACTUAL,2022-04-12,2022-05-09,ACTUAL,2021-12-06,2021-12-08,ACTUAL,2024-07-09,2024-07-18,ACTUAL,2018-05-29,ACTUAL,2018-05-29,2024-07,2024-07-31,2023-12-14,ACTUAL,2023-12-14,2021-01-27,ACTUAL,2021-01-27,,INTERVENTIONAL,VISION,,Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer,"VISION: An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)",COMPLETED,,PHASE3,831.0,ACTUAL,Endocyte,,2.0,,,t,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,INDUSTRY,,NCT04825652,NO_LONGER_AVAILABLE,,,,2023,1.0
NCT03027167,,2017-01-03,,,2017-05-10,2017-01-18,2017-01-23,ESTIMATED,,,,,,,2017-05-10,2017-05-12,ACTUAL,2017-01,,2017-01-31,2017-05,2017-05-31,2023-01,ESTIMATED,2023-01-31,2019-01,ESTIMATED,2019-01-31,,INTERVENTIONAL,PDAS,,Outcomes Study in Patients Receiving Aspirin With Mechanical Compression Devices Versus Aspirin Alone Following Knee and Hip Arthroplasty,Outcomes Study to Determine the Incidence of Symptomatic DVT/PE in Patients Receiving Aspirin With Mechanical Compression Devices Versus Aspirin Alone Following Knee and Hip Arthroplasty,WITHDRAWN,,PHASE4,0.0,ACTUAL,Washington University School of Medicine,,2.0,,,f,,,,f,,,,,,,,,,,UNDECIDED,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,OTHER,,,,,,,2023,0.0
NCT04269707,,2020-02-12,2021-11-02,,2022-03-17,2020-02-13,2020-02-17,ACTUAL,2022-03-17,2022-03-21,ACTUAL,,,,2022-03-17,2022-03-21,ACTUAL,2019-11-19,ACTUAL,2019-11-19,2022-03,2022-03-31,2021-01-29,ACTUAL,2021-01-29,2020-12-30,ACTUAL,2020-12-30,,INTERVENTIONAL,,,Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044,Evaluating the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and an Unsatisfactory Response to Oral Iron Under Study Protocol 1VIT17044,COMPLETED,,PHASE3,7.0,ACTUAL,"American Regent, Inc.",,1.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,INDUSTRY,,,,,,,2021,1.0
NCT04249713,,2020-01-29,,,2020-09-02,2020-01-29,2020-01-31,ACTUAL,,,,,,,2020-09-02,2020-09-04,ACTUAL,2020-02-03,ACTUAL,2020-02-03,2020-09,2020-09-30,2020-09,ESTIMATED,2020-09-30,2020-07,ESTIMATED,2020-07-31,,INTERVENTIONAL,,,An Alternative Dose Interval Study in Participants With Hidradenitis Suppurativa Receiving Brodalumab,An Alternative Dose Interval Study to Examine Safety and Identify Potential Biomarkers in Participants With Hidradenitis Suppurativa Receiving Brodalumab,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Rockefeller University,,1.0,,Biomarker Samples Not Collected,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 18:03:23.937454,2024-10-15 18:03:23.937454,OTHER,,,,,,,2020,0.0
NCT01649388,,2012-06-29,,,2023-02-28,2012-07-20,2012-07-25,ESTIMATED,,,,,,,2023-02-28,2023-03-02,ACTUAL,2012-10-15,ACTUAL,2012-10-15,2023-02,2023-02-28,2023-02-28,ACTUAL,2023-02-28,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,FREEDOM-2,,A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients,"A Single-arm, Multi-center, Exploratory Safety and Efficacy Study of FCR001 Cell-based Therapy to Induce Donor-specific Tolerance in Previously Transplanted Recipients of a Kidney From a Living Donor, and Safety in FCR001 Donors",WITHDRAWN,,PHASE2,0.0,ACTUAL,Talaris Therapeutics Inc.,,1.0,,study terminated by sponsor,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,INDUSTRY,,,,,,,2023,0.0
NCT04205435,,2019-12-18,,,2022-10-09,2019-12-18,2019-12-19,ACTUAL,,,,,,,2022-10-09,2022-10-13,ACTUAL,2021-11-01,ACTUAL,2021-11-01,2021-09,2021-09-30,2022-07-25,ACTUAL,2022-07-25,2022-06-01,ACTUAL,2022-06-01,,INTERVENTIONAL,,,β-globin Restored Autologous HSC in β-thalassemia Major Patients,a Safety and Efficacy Study of β-globin Restored Autologous Hematopoietic Stem Cells for β-thalassemia Major Patients With CVS-654 Mutation,TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,Bioray Laboratories,,1.0,,Sponsor decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,INDUSTRY,,,,,,,2022,0.0
NCT04242173,,2020-01-23,2022-05-27,,2022-11-02,2020-01-23,2020-01-27,ACTUAL,2022-06-22,2022-07-14,ACTUAL,,,,2022-11-02,2022-11-04,ACTUAL,2020-06-25,ACTUAL,2020-06-25,2022-11,2022-11-30,2022-05-26,ACTUAL,2022-05-26,2022-05-26,ACTUAL,2022-05-26,,INTERVENTIONAL,,Study terminated early due to lack of interest,Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCC,A Single Arm Phase II Study of Cemiplimab-rwlc in Immunocompromised Patients With Unresectable Locally Recurrent and/or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC),TERMINATED,,PHASE2,3.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,1.0,,Lack of Interest,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-15 08:08:58.904705,2024-10-15 08:08:58.904705,OTHER,,,,,,,2022,0.0
NCT04594811,,2020-10-14,,,2024-08-14,2020-10-14,2020-10-20,ACTUAL,,,,,,,2024-08-14,2024-08-16,ACTUAL,2021-01-21,ACTUAL,2021-01-21,2024-04,2024-04-30,2023-05-26,ACTUAL,2023-05-26,2023-05-26,ACTUAL,2023-05-26,,INTERVENTIONAL,,,"NT-I7 in Combination With Nivolumab in Advanced Gastric, Gastro-Esophageal Junction or Esophageal Adenocarcinoma","A Multicenter, Open-label, Phase 1 Dose Escalation ,Phase 2 Study of NT-I7 in Combination With Nivolumab in Subjects With Relapsed/Refractory Gastric or Gastro-Esophageal Junction or Esophageal Adenocarcinoma Who Progressed on or Intolerant to 2 or More Prior Lines of Systemic Therapy",TERMINATED,,PHASE1,10.0,ACTUAL,NeoImmuneTech,,2.0,,Company strategic decision,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,INDUSTRY,,,,,,,2023,0.0
NCT04558684,,2020-09-16,,,2023-12-31,2020-09-16,2020-09-22,ACTUAL,,,,,,,2023-12-31,2024-01-03,ACTUAL,2019-11-01,ACTUAL,2019-11-01,2023-12,2023-12-31,2023-12-30,ESTIMATED,2023-12-30,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,,,Radiotherapy With Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer,Short Course Radiotherapy With Total Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer,SUSPENDED,,PHASE1/PHASE2,30.0,ACTUAL,"Wuhan Union Hospital, China",,1.0,,Inadequate patient enrollment,f,,,,,f,f,,,,,,,,,,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,OTHER,,,,,,,2023,0.0
NCT02611960,,2015-11-19,2021-11-16,,2023-06-26,2015-11-19,2015-11-23,ESTIMATED,2021-11-16,2021-12-15,ACTUAL,,,,2023-06-26,2023-07-13,ACTUAL,2016-04-18,ACTUAL,2016-04-18,2023-06,2023-06-30,2022-09-30,ACTUAL,2022-09-30,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,,,Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122),"A Two-arm, Open-label, Randomized Phase III Study of Pembrolizumab (MK-3475) Monotherapy Versus Standard Chemotherapy in Platinum Pre-treated, Recurrent or Metastatic Nasopharyngeal Cancer (NPC) (Keynote-122)",COMPLETED,,PHASE3,233.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,INDUSTRY,,,,,,,2022,1.0
NCT04377945,,2020-05-04,,,2024-06-14,2020-05-04,2020-05-07,ACTUAL,,,,,,,2024-06-14,2024-06-17,ACTUAL,2021-04-28,ACTUAL,2021-04-28,2024-06,2024-06-30,2024-02-14,ACTUAL,2024-02-14,2024-02-14,ACTUAL,2024-02-14,,INTERVENTIONAL,SHINE,,Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components,"A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and Its Individual Components",TERMINATED,,PHASE2,41.0,ACTUAL,Bukwang Pharmaceutical,,8.0,,Business reasons,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,INDUSTRY,,,,,,,2024,0.0
NCT03145064,,2017-05-05,2021-08-31,,2021-10-11,2017-05-05,2017-05-09,ACTUAL,2021-10-11,2021-11-08,ACTUAL,,,,2021-10-11,2021-11-08,ACTUAL,2017-06-30,ACTUAL,2017-06-30,2021-10,2021-10-31,2020-09-03,ACTUAL,2020-09-03,2019-05-24,ACTUAL,2019-05-24,,INTERVENTIONAL,,,Study of BTK Inhibitor Zanubrutinib in Participants With Relapsed/Refractory Non-GCB Type Diffuse Large B Cell Lymphoma,"A Phase 2, Single Arm, Multicenter, Open-label Study of Bruton's Tyrosine Kinase (BTK) Inhibitor BGB-3111 in Subjects With Relapsed/Refractory Non-GCB Type Diffuse Large B Cell Lymphoma",COMPLETED,,PHASE2,41.0,ACTUAL,BeiGene,,1.0,,,f,,,,t,f,f,,,,,,,,,YES,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,INDUSTRY,,,,,,,2020,1.0
NCT03057509,,2017-02-03,,,2019-06-19,2017-02-15,2017-02-20,ACTUAL,,,,,,,2019-06-19,2019-06-21,ACTUAL,2018-11,ESTIMATED,2018-11-30,2019-06,2019-06-30,2021-09-30,ESTIMATED,2021-09-30,2019-10-31,ESTIMATED,2019-10-31,,INTERVENTIONAL,,,A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors,A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors,WITHDRAWN,,PHASE1,0.0,ACTUAL,Massachusetts General Hospital,,1.0,,Slow accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,OTHER,,,,,,,2021,0.0
NCT04052139,,2019-08-08,2022-09-09,,2022-10-14,2019-08-08,2019-08-09,ACTUAL,2022-10-14,2022-11-10,ACTUAL,,,,2022-10-14,2022-11-10,ACTUAL,2021-01-25,ACTUAL,2021-01-25,2022-10,2022-10-31,2021-12-15,ACTUAL,2021-12-15,2021-11-16,ACTUAL,2021-11-16,,INTERVENTIONAL,UH3,,St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin,Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems,COMPLETED,,PHASE2,45.0,ACTUAL,Boston Medical Center,,3.0,,,f,,,,t,f,f,,,,,,,,,YES,All data from the study will be placed into the URBAN ARCH repository.,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,OTHER,,,,,,,2021,1.0
NCT02966314,,2016-11-15,2021-08-31,2021-02-12,2022-10-10,2016-11-15,2016-11-17,ESTIMATED,2021-10-21,2021-11-22,ACTUAL,2021-10-21,2021-11-22,ACTUAL,2022-10-10,2022-11-01,ACTUAL,2017-03-30,ACTUAL,2017-03-30,2022-10,2022-10-31,2020-01-06,ACTUAL,2020-01-06,2020-01-06,ACTUAL,2020-01-06,,INTERVENTIONAL,,Two participants enrolled onto the study were screened but not randomized to an arm.,Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy,"A Phase IV, Randomized, Double-Blind, Placebo-Controlled Exploratory Study of Xolair (Omalizumab) for Treatment of Idiopathic Angioedema in Patients Who Remain Symptomatic Despite Current Therapy",COMPLETED,,PHASE4,12.0,ACTUAL,"University of Wisconsin, Madison",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,OTHER,,,,,,,2020,1.0
NCT05005910,,2020-12-12,,,2023-10-25,2021-08-06,2021-08-16,ACTUAL,,,,,,,2023-10-25,2023-10-27,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2023-10,2023-10-31,2022-12-01,ACTUAL,2022-12-01,2022-12-01,ACTUAL,2022-12-01,,INTERVENTIONAL,,,Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis,Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis,COMPLETED,,EARLY_PHASE1,194.0,ACTUAL,Mahidol University,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,OTHER,,,,,,,2022,1.0
NCT03949842,,2019-05-13,,,2020-04-21,2019-05-13,2019-05-14,ACTUAL,,,,,,,2020-04-21,2020-04-22,ACTUAL,2019-06-27,ACTUAL,2019-06-27,2020-04,2020-04-30,2022-11-30,ESTIMATED,2022-11-30,2022-11-30,ESTIMATED,2022-11-30,,INTERVENTIONAL,LEGEND,,Legend: TRELEGY Real World Chronic Obstructive Pulmonary Disease (COPD) Effectiveness Study,A Comparison of the Clinical Effectiveness of Inhaled Triple Therapy (Fluticasone Furoate / Umeclidinium Bromide / Vilanterol) in a Single Inhaler (TRELEGY™ ELLIPTA™) With Inhaled Non-ELLIPTA™ Multiple Inhaler Triple Therapies in COPD Patients in the US Within a Usual Care Setting in a Prospective Pre-Post Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,GlaxoSmithKline,,2.0,,The decision to end the study was based on a change in GSK strategy. No subjects were enrolled into the study.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,INDUSTRY,,,,,,,2022,0.0
NCT05296733,,2022-03-23,,,2024-08-13,2022-03-23,2022-03-25,ACTUAL,,,,,,,2024-08-13,2024-08-15,ACTUAL,2022-04-27,ACTUAL,2022-04-27,2024-08,2024-08-31,2023-12-29,ACTUAL,2023-12-29,2023-12-29,ACTUAL,2023-12-29,,INTERVENTIONAL,,,"A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906","A Non-randomised, Open-label, 2-part, Parallel-cohort Trial to Evaluate 1) Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of BI 456906 in Patients With Cirrhosis and Varying Degrees of Hepatic Impairment Relative to Healthy Subjects With and Without Overweight/Obesity and 2) Safety and Tolerability of Multiple Subcutaneous Doses of BI 456906 in Patients With Overweight/Obesity With Cirrhosis and Varying Degrees of Hepatic Impairment Relative to Patients With Overweight/Obesity Without Cirrhosis/Hepatic Impairment",COMPLETED,,PHASE1,82.0,ACTUAL,Boehringer Ingelheim,,7.0,,,f,,,,f,t,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).~For more details refer to:~https://www.mystudywindow.com/msw/datatransparency",2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,INDUSTRY,,,,,,,2023,1.0
NCT04449861,,2020-05-06,,,2023-07-21,2020-06-26,2020-06-29,ACTUAL,,,,,,,2023-07-21,2023-07-24,ACTUAL,2020-12-07,ACTUAL,2020-12-07,2023-07,2023-07-31,2023-03-30,ACTUAL,2023-03-30,2023-03-30,ACTUAL,2023-03-30,,INTERVENTIONAL,,,Durvalumab Plus Chemotherapy in ES-SCLC (Oriental),"An Open Label, Multicenter Study of First-Line Durvalumab Plus Platinum-Based Chemotherapy in Chinese Patients With Extensive Stage Small-Cell Lung Cancer (Oriental)",COMPLETED,,PHASE3,166.0,ACTUAL,AstraZeneca,,1.0,,,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,INDUSTRY,,,,,,,2023,1.0
NCT04398316,,2020-05-07,2022-09-06,,2023-12-26,2020-05-18,2020-05-21,ACTUAL,2023-12-26,2024-01-17,ACTUAL,,,,2023-12-26,2024-01-17,ACTUAL,2021-02-18,ACTUAL,2021-02-18,2023-12,2023-12-31,2021-06-30,ACTUAL,2021-06-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,HIDO-LIDO,,High Dose IV Lidocaine vs Hydromorphone for Abdominal Pain in the Emergency Department,"High Dose Intravenous Lidocaine vs Hydromorphone for Acute Abdominal Pain in the Emergency Department: A Randomized, Comparative Efficacy Trial",TERMINATED,,PHASE4,4.0,ACTUAL,Hennepin Healthcare Research Institute,No statistical analysis was done due to enrolling only 4 subjects before the trial was terminated.,2.0,,Administrative,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,OTHER,,,,,,,2021,0.0
NCT03242889,,2017-08-04,,,2023-04-13,2017-08-04,2017-08-08,ACTUAL,,,,,,,2023-04-13,2023-04-14,ACTUAL,2017-08-10,ACTUAL,2017-08-10,2023-04,2023-04-30,2023-02-10,ACTUAL,2023-02-10,2017-11-01,ACTUAL,2017-11-01,,INTERVENTIONAL,,,A Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Japanese Participants With Relapsed or Refractory Multiple Myeloma,A Phase 1 Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Japanese Participants With Relapsed or Refractory Multiple Myeloma,COMPLETED,,PHASE1,6.0,ACTUAL,Janssen Pharmaceutical K.K.,,1.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,INDUSTRY,,,,,,,2023,1.0
NCT03792503,,2019-01-02,,,2024-02-26,2019-01-02,2019-01-03,ACTUAL,,,,,,,2024-02-26,2024-02-28,ACTUAL,2019-02,ESTIMATED,2019-02-28,2024-02,2024-02-29,2022-02,ESTIMATED,2022-02-28,2020-02,ESTIMATED,2020-02-29,,INTERVENTIONAL,,,Pemetrexed Plus Apatinib Maintenance Treatment in Patients With Non-squamous Non-small Cell Lung Cancer Patients Who Have Not Progressed After 4 Cycles of Induction Chemotherapy of Pemetrexed in Combination With Platinum-based Regimen,"Pemetrexed Plus Apatinib Maintenance Treatment in Patients With Non-squamous Non-small Cell Lung Cancer Patients Who Have Not Progressed After 4 Cycles of Induction Chemotherapy of Pemetrexed in Combination With Platinum-based Regimen: A Prospective, Open, One-arm Clinical Study",WITHDRAWN,,PHASE4,0.0,ACTUAL,Xinqiao Hospital of Chongqing,,1.0,,abandon,f,,,,,f,f,,,,,,,,,,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,OTHER,,,,,,,2022,0.0
NCT04171765,,2019-11-19,2024-01-19,,2024-04-08,2019-11-19,2019-11-21,ACTUAL,2024-04-08,2024-04-16,ACTUAL,,,,2024-04-08,2024-04-16,ACTUAL,2020-09-30,ACTUAL,2020-09-30,2024-04,2024-04-30,2023-01-23,ACTUAL,2023-01-23,2023-01-23,ACTUAL,2023-01-23,,INTERVENTIONAL,BANFF,,"A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis","A Phase II, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Patients With Non-Alcoholic Steatohepatitis",TERMINATED,,PHASE2,46.0,ACTUAL,"Genentech, Inc.","Because the study was terminated early, the interpretation of its data is limited, and early dropout may confound the results.",4.0,,The study was terminated due to strategic business reasons.,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,INDUSTRY,,,,,,,2023,0.0
NCT02398656,,2015-03-20,,,2024-08-14,2015-03-24,2015-03-25,ESTIMATED,,,,,,,2024-08-14,2024-08-16,ACTUAL,2015-04-01,ACTUAL,2015-04-01,2024-08,2024-08-31,2024-04-10,ACTUAL,2024-04-10,2024-01-19,ACTUAL,2024-01-19,,INTERVENTIONAL,TEMPO-2,,A Randomized Controlled Trial of TNK-tPA Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion,"Multicentre, Prospective Randomized Open Label, Blinded-endpoint (PROBE) Controlled Trial of Thrombolysis With Low Dose Tenecteplase (TNK-tPA) Versus Standard of Care in Minor Ischemic Stroke With Proven Acute Symptomatic Occlusion",COMPLETED,,PHASE3,886.0,ACTUAL,University of Calgary,,2.0,,,f,,,,t,,,,,,,,,,,NO,Overall data will be shared once the trial has been closed and data analysed. No individual participant data will be available.,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,OTHER,,,,,,,2024,1.0
NCT03063203,,2017-02-20,2022-01-24,,2022-05-09,2017-02-20,2017-02-24,ACTUAL,2022-02-18,2022-03-18,ACTUAL,,,,2022-05-09,2022-06-02,ACTUAL,2017-07-14,ACTUAL,2017-07-14,2022-05,2022-05-31,2022-03-16,ACTUAL,2022-03-16,2021-02-13,ACTUAL,2021-02-13,,INTERVENTIONAL,,,Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia,"An Open Label, Multicenter, Phase II Trial Testing Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia",TERMINATED,,PHASE2,17.0,ACTUAL,Washington University School of Medicine,,1.0,,Futility,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,OTHER,,,,,,,2022,0.0
NCT03139370,,2017-04-26,,,2023-08-23,2017-05-02,2017-05-03,ACTUAL,,,,,,,2023-08-23,2023-08-25,ACTUAL,2017-12-27,ACTUAL,2017-12-27,2023-08,2023-08-31,2023-06-04,ACTUAL,2023-06-04,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,,,Safety and Efficacy of MAGE-A3/A6 T Cell Receptor Engineered T Cells (KITE-718) in HLA-DPB1*04:01 Positive Adults With Advanced Cancers,A Phase 1 Study Evaluating the Safety and Efficacy of MAGE-A3/A6 T Cell Receptor Engineered T Cells (KITE-718) in HLA-DPB1*04:01 Positive Subjects With Advanced Cancers,TERMINATED,,PHASE1,16.0,ACTUAL,Gilead Sciences,,1.0,,The study was terminated due to the sponsor's decision to discontinue the clinical trial.,f,,,,f,t,t,t,,,,,,,,NO,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,INDUSTRY,,,,,,,2023,0.0
NCT02714530,,2015-09-10,,,2021-03-25,2016-03-15,2016-03-21,ESTIMATED,,,,,,,2021-03-25,2021-03-30,ACTUAL,2014-04-01,ACTUAL,2014-04-01,2021-03,2021-03-31,2020-12-30,ACTUAL,2020-12-30,2020-12-30,ACTUAL,2020-12-30,,INTERVENTIONAL,ThoRaT,,Thoracal Radiotherapy and Tarceva,Concomitant Radiotherapy and Erlotinib in Advanced Lung Cancer,TERMINATED,,PHASE2,118.0,ACTUAL,Oslo University Hospital,,2.0,,Slow accrual,f,,,,t,,,,,,,,,,,YES,Publish results,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,OTHER,,,,,,,2020,0.0
NCT03633617,,2018-08-14,2022-09-04,,2023-06-02,2018-08-14,2018-08-16,ACTUAL,2022-12-06,2022-12-28,ACTUAL,,,,2023-06-02,2023-06-28,ACTUAL,2018-09-24,ACTUAL,2018-09-24,2023-06,2023-06-30,2022-06-07,ACTUAL,2022-06-07,2021-09-09,ACTUAL,2021-09-09,,INTERVENTIONAL,,Part A Full analysis set (FAS) includes all randomized participants in Part A; Part B FAS includes all randomized participants in Part B. Participants who participated in Part A were not eligible to participate in Part B.,Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE),"A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)",COMPLETED,,PHASE3,321.0,ACTUAL,Regeneron Pharmaceuticals,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,INDUSTRY,,,,,,,2022,1.0
NCT04718961,,2021-01-19,2023-11-30,,2024-07-11,2021-01-19,2021-01-22,ACTUAL,2024-07-11,2024-08-06,ACTUAL,,,,2024-07-11,2024-08-06,ACTUAL,2021-01-04,ACTUAL,2021-01-04,2024-07,2024-07-31,2022-12-07,ACTUAL,2022-12-07,2022-12-07,ACTUAL,2022-12-07,,INTERVENTIONAL,OHANA,Part 2 was early terminated due to lack of enrollment and the company's assessment of enrollment feasibility.,A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA),A Phase 2a/2b Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in Adult Women With Intrahepatic Cholestasis of Pregnancy and Elevated Serum Bile Acid Concentrations (OHANA).,TERMINATED,,PHASE2,4.0,ACTUAL,"Mirum Pharmaceuticals, Inc.",,4.0,,Due to company's assessment of enrollment feasibility.,f,,,,,t,f,,,,,,,,,,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,INDUSTRY,,,,,,,2022,0.0
NCT04562467,,2020-09-13,,,2024-03-31,2020-09-18,2020-09-24,ACTUAL,,,,,,,2024-03-31,2024-04-02,ACTUAL,2020-09-24,ACTUAL,2020-09-24,2024-03,2024-03-31,2023-05-25,ACTUAL,2023-05-25,2023-05-25,ACTUAL,2023-05-25,,INTERVENTIONAL,IPE-PREVENTION,,The Use of Icosapent Ethyl on Vascular Progenitor Cells in Individuals With Elevated Cardiovascular Risk,The Icosapent Ethyl and Prevention of Vascular Regenerative Cell Exhaustion Study,COMPLETED,,PHASE4,70.0,ACTUAL,Canadian Medical and Surgical Knowledge Translation Research Group,,2.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,OTHER,,,,,,,2023,1.0
NCT04001517,,2019-06-07,2021-06-29,,2023-06-10,2019-06-26,2019-06-28,ACTUAL,2021-10-28,2021-11-02,ACTUAL,,,,2023-06-10,2023-06-29,ACTUAL,2019-09-30,ACTUAL,2019-09-30,2023-06,2023-06-30,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,AscenD-LB,,Cognitive Effects of Oral p38 Alpha Kinase Inhibitor Neflamapimod in Dementia With Lewy Bodies,"A Double-Blind, Placebo-Controlled 16-Week Study of the Cognitive Effects of Oral p38 Alpha Kinase Inhibitor Neflamapimod in Dementia With Lewy Bodies (DLB)",COMPLETED,,PHASE2,91.0,ACTUAL,EIP Pharma Inc,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:03:23.937454,2024-10-15 18:03:23.937454,INDUSTRY,,,,,,,2020,1.0
NCT04831450,,2021-04-01,,,2022-08-01,2021-04-01,2021-04-05,ACTUAL,,,,,,,2022-08-01,2022-08-04,ACTUAL,2022-07,ESTIMATED,2022-07-31,2022-08,2022-08-31,2022-07-15,ACTUAL,2022-07-15,2022-07-15,ACTUAL,2022-07-15,,INTERVENTIONAL,,,Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC),Phase II Trial of Maintenance Cemiplimab-rwlc After Concurrent Chemoradiotherapy (CRT) in Intermediate and High-Risk Head and Neck Squamous Cell Carcinoma (HNSCC),WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Miami,,1.0,,Investigator Decision,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,OTHER,,,,,,,2022,0.0
NCT05292755,,2022-03-14,2023-01-09,,2023-03-29,2022-03-14,2022-03-23,ACTUAL,2023-03-29,2023-04-20,ACTUAL,,,,2023-03-29,2023-04-20,ACTUAL,2022-04-22,ACTUAL,2022-04-22,2023-03,2023-03-31,2022-07-01,ACTUAL,2022-07-01,2022-05-30,ACTUAL,2022-05-30,,INTERVENTIONAL,,,Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome,"Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome: a Randomized, Controlled, Double-Blind Study",COMPLETED,,PHASE4,80.0,ACTUAL,University of Florida,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,OTHER,,,,,,,2022,1.0
NCT03036904,,2017-01-27,,,2022-08-23,2017-01-27,2017-01-30,ESTIMATED,,,,,,,2022-08-23,2022-08-24,ACTUAL,2017-02-06,ACTUAL,2017-02-06,2022-08,2022-08-31,2021-11-11,ACTUAL,2021-11-11,2021-11-11,ACTUAL,2021-11-11,,INTERVENTIONAL,V+DA-EPOCH-R,,Study of Venetoclax Plus DA-EPOCH-R for the Treatment of Aggressive B-Cell Lymphomas,Phase I Study of Venetoclax Plus DA-EPOCH-R for the Treatment of Aggressive B-Cell Lymphomas,COMPLETED,,PHASE1,31.0,ACTUAL,Weill Medical College of Cornell University,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,OTHER,,,,,,,2021,1.0
NCT04761822,,2021-02-17,2023-04-13,,2023-11-30,2021-02-17,2021-02-21,ACTUAL,2023-05-22,2023-06-15,ACTUAL,,,,2023-11-30,2023-12-04,ACTUAL,2021-04-07,ACTUAL,2021-04-07,2023-11,2023-11-30,2022-04-27,ACTUAL,2022-04-27,2022-04-20,ACTUAL,2022-04-20,,INTERVENTIONAL,SARS,All participants who initiated study treatment.,COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations,Systemic Allergic Reactions to SARS-CoV-2 Vaccination,COMPLETED,,PHASE2,746.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,4.0,,,f,,,,t,t,f,,,,,,"After completion of the trial, within 24 months status post database lock.","Registration is available for the Immunology Database and Analysis Portal (ImmPort) at: https://www.immport.org/registration. Submit a rationale for the purpose of requesting study data access.~ImmPort is a long-term archive of clinical and mechanistic data, a National Institute of Allergy and Infectious Diseases Division of Allergy, Immunology and Transplantation (NIAID DAIT)-funded data repository. This archive is in support of the NIH mission to share data with the public. Data shared through ImmPort is provided by NIH-funded programs, other research organizations and individual scientists, ensuring these discoveries will be the foundation of future research.",https://www.immport.org/home,YES,Participant level data access and additional relevant materials will be made available upon completion of the trial.,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,NIH,,,,,,,2022,1.0
NCT04042480,,2019-07-31,,,2023-03-21,2019-07-31,2019-08-02,ACTUAL,,,,,,,2023-03-21,2023-03-23,ACTUAL,2019-09-03,ACTUAL,2019-09-03,2023-03,2023-03-31,2023-03-09,ACTUAL,2023-03-09,2023-03-09,ACTUAL,2023-03-09,,INTERVENTIONAL,,,A Study of SGN-CD228A in Advanced Solid Tumors,A Phase 1 Study of SGN-CD228A in Select Advanced Solid Tumors,TERMINATED,,PHASE1,88.0,ACTUAL,Seagen Inc.,,1.0,,Study closed due to portfolio prioritization,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,INDUSTRY,,,,,,,2023,0.0
NCT05593770,,2022-10-21,,,2024-03-06,2022-10-21,2022-10-25,ACTUAL,,,,,,,2024-03-06,2024-03-08,ACTUAL,2022-10-27,ACTUAL,2022-10-27,2024-03,2024-03-31,2024-02-01,ACTUAL,2024-02-01,2023-12-14,ACTUAL,2023-12-14,,INTERVENTIONAL,NECTAR,,International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response,"International Sites: CONNECTS Master Protocol for Clinical Trials Targeting Macro-, Micro-immuno-thrombosis, Vascular Hyperinflammation, and Hypercoagulability and Renin-angiotensin-aldosterone System (RAAS) in Hospitalized Patients With COVID-19 (ACTIV-4 Host Tissue)",TERMINATED,,PHASE2/PHASE3,28.0,ACTUAL,NEAT ID Foundation,,2.0,,"Following a meeting of the DSMB on 20th September 2023, the recommendation was made to the sponsor on 26th September 2023 that the Fostamatinib arm of the trial ceases enrolment and study medication is discontinued immediately.",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,OTHER,,,,,,,2024,0.0
NCT03492164,,2018-04-03,,,2024-06-11,2018-04-03,2018-04-10,ACTUAL,,,,,,,2024-06-11,2024-06-12,ACTUAL,2018-03-20,ACTUAL,2018-03-20,2024-06,2024-06-30,2024-06-11,ACTUAL,2024-06-11,2024-06-11,ACTUAL,2024-06-11,,INTERVENTIONAL,,,In Vivo PARP-1 Expression With 18F-FTT PET/CT in Pancreatic Cancer,Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Pancreatic Cancer,TERMINATED,,EARLY_PHASE1,6.0,ACTUAL,Abramson Cancer Center at Penn Medicine,,1.0,,Early analysis of images after 6 patients showed no activity of the radiotracer in this patient population.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,OTHER,,,,,,,2024,0.0
NCT05085002,,2021-09-07,,,2024-03-08,2021-10-06,2021-10-20,ACTUAL,,,,,,,2024-03-08,2024-03-12,ACTUAL,2021-12-21,ACTUAL,2021-12-21,2023-12,2023-12-31,2023-11-29,ACTUAL,2023-11-29,2023-11-29,ACTUAL,2023-11-29,,INTERVENTIONAL,,,A Study of Lerociclib in Participants With Advanced Breast Cancer,A Phase 2 Study to Evaluate the Safety and Efficacy of Lerociclib in Participants With Advanced Breast Cancer,TERMINATED,,PHASE2,100.0,ACTUAL,"EQRx International, Inc.",,1.0,,The study is being closed based on corporate changes at EQRx and is not related to any efficacy or safety issues with lerociclib.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,INDUSTRY,,,,,,,2023,0.0
NCT04700267,,2021-01-06,,,2021-10-14,2021-01-06,2021-01-07,ACTUAL,,,,,,,2021-10-14,2021-10-21,ACTUAL,2020-12-28,ACTUAL,2020-12-28,2021-10,2021-10-31,2021-10-06,ACTUAL,2021-10-06,2021-10-06,ACTUAL,2021-10-06,,INTERVENTIONAL,TAPINOMA,,A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus Erythematosus,"A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Systemic Lupus Erythematosus",TERMINATED,,PHASE1,11.0,ACTUAL,Galapagos NV,,2.0,,Study stopped on business grounds,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,INDUSTRY,,,,,,,2021,0.0
NCT03161132,,2017-05-17,,,2023-01-25,2017-05-17,2017-05-19,ACTUAL,,,,,,,2023-01-25,2023-01-27,ACTUAL,2017-12-13,ACTUAL,2017-12-13,2023-01,2023-01-31,2022-12-31,ACTUAL,2022-12-31,2020-02-07,ACTUAL,2020-02-07,,INTERVENTIONAL,ROLANDO,,"Resistant Ovarian Cancer, Olaparib and Liposomal Doxorubicin","Multicentric Single Arm Phase II Clinical Trial, to Evaluate Safety and Efficacy of the Combination of Olaparib and PLD for Platinum Resistant Ovarian Primary Peritoneal Carcinoma, and Fallopian Tube Cancer Patients.",COMPLETED,,PHASE2,32.0,ACTUAL,Grupo Español de Investigación en Cáncer de Ovario,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,OTHER,,,,,,,2022,1.0
NCT03926143,,2019-04-23,2023-04-28,,2023-07-14,2019-04-23,2019-04-24,ACTUAL,2023-07-14,2023-08-04,ACTUAL,,,,2023-07-14,2023-08-04,ACTUAL,2019-06-03,ACTUAL,2019-06-03,2023-07,2023-07-31,2022-05-18,ACTUAL,2022-05-18,2022-05-18,ACTUAL,2022-05-18,,INTERVENTIONAL,,,A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies,"An Open-label, Multicenter Rollover Study to Provide Continued Treatment With Anetumab Ravtansine for Participants With Solid Tumors Who Were Enrolled in Previous Bayer-sponsored Studies",TERMINATED,,PHASE2,9.0,ACTUAL,Bayer,"Due to the small sample size and heterogeneous population, survival distributions and the extent of long-term survival in the applicable populations cannot be reliably estimated from the study results.~Overall results were reported. Pooling was done because there is only a single patient treated with combination and no summary tables on a single patient.",1.0,,"Due to strategic company decisions, the development of anetumab ravtansine was stopped.",f,,,,f,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,INDUSTRY,,,,,,,2022,0.0
NCT04321343,,2020-03-23,2023-06-19,,2023-08-04,2020-03-23,2020-03-25,ACTUAL,2023-08-04,2023-08-29,ACTUAL,,,,2023-08-04,2023-08-29,ACTUAL,2020-09-01,ACTUAL,2020-09-01,2023-08,2023-08-31,2022-06-20,ACTUAL,2022-06-20,2022-06-08,ACTUAL,2022-06-08,,INTERVENTIONAL,,"Intent to treat set (ITTS), defined as all as-randomized patients who received at least one dose of study treatment",Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH),"A 36-week, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Efficacy and Safety of PXL065 Versus Placebo in Noncirrhotic Biopsy-proven NonAlcoholic SteatoHepatitis (NASH) Patients",COMPLETED,,PHASE2,117.0,ACTUAL,Poxel SA,"Limitations of this trial included a relatively small sample size and treatment duration. However, given a close relationship to the parent molecule, pioglitazone, the potential for unforeseen safety issues is low and the present results can be viewed as confirmatory with respect to efficacy.",4.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,INDUSTRY,,,,,,,2022,1.0
NCT05381350,,2022-05-18,,,2024-05-30,2022-05-18,2022-05-19,ACTUAL,,,,,,,2024-05-30,2024-05-31,ACTUAL,2022-06-01,ACTUAL,2022-06-01,2024-05,2024-05-31,2023-03-09,ACTUAL,2023-03-09,2022-09-26,ACTUAL,2022-09-26,,INTERVENTIONAL,,,"Immunogenicity and Safety of Booster Immunization of COVID-19 Vaccine (Vero Cell), Inactivated (Omicron Variant) in Healthy People Aged 18 Years and Above","A Randomized, Double-blind, Active-controlled Clinical Trial, as Well as an Immuno-bridging Clinical Trial by Parallel Testing Previous Serum After Primary Immunization, to Evaluate the Immunogenicity and Safety of Booster Immunization of COVID-19 Vaccine (Vero Cell), Inactivated (Omicron Variant) in Healthy People Aged 18 Years and Above",COMPLETED,,PHASE3,1750.0,ACTUAL,"Sinovac Biotech Co., Ltd",,9.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 06:08:51.115534,2024-10-16 06:08:51.115534,INDUSTRY,,,,,,,2023,1.0
NCT02337270,,2014-12-19,,,2021-10-25,2015-01-08,2015-01-13,ESTIMATED,,,,,,,2021-10-25,2021-11-01,ACTUAL,2017-09-05,ACTUAL,2017-09-05,2021-10,2021-10-31,2021-09-07,ACTUAL,2021-09-07,2021-09-07,ACTUAL,2021-09-07,,INTERVENTIONAL,,,Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol,"Phase 1, Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of an Adenovirus-based Tuberculosis Vaccine Administered by Aerosol",COMPLETED,,PHASE1,36.0,ACTUAL,McMaster University,,3.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,OTHER,,,,,,,2021,1.0
NCT04806503,,2021-03-16,2023-07-14,2023-05-01,2024-06-17,2021-03-16,2021-03-19,ACTUAL,2023-08-07,2023-08-30,ACTUAL,,2023-08-30,ACTUAL,2024-06-17,2024-06-20,ACTUAL,2021-06-30,ACTUAL,2021-06-30,2024-06,2024-06-30,2022-10-14,ACTUAL,2022-10-14,2022-07-27,ACTUAL,2022-07-27,,INTERVENTIONAL,READER,,A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.,"A Randomized, Placebo-controlled, Double-masked, Multi-center, Dose-ranging Study to Evaluate the Safety, and Efficacy of UNR844 in Subjects With Presbyopia",TERMINATED,,PHASE2,234.0,ACTUAL,Novartis,,5.0,,The study was discontinued by the Sponsor because it did not achieve the primary objective.,f,,,,f,t,f,,,,,,,,https://clinicalstudydatarequest.com/,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.",2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,INDUSTRY,,,,,,,2022,0.0
NCT03894046,,2019-03-27,2022-11-07,,2023-01-05,2019-03-27,2019-03-28,ACTUAL,2023-01-05,2023-02-01,ACTUAL,,,,2023-01-05,2023-02-01,ACTUAL,2019-09-05,ACTUAL,2019-09-05,2023-01,2023-01-31,2021-07-26,ACTUAL,2021-07-26,2021-07-26,ACTUAL,2021-07-26,,INTERVENTIONAL,ATTACK,Two (2) participants were transferred from Part A to part B. These participants were analyzed at each arm until/ from the time point of transfer. The number of participants is reported according to the initial Arm/group in which individual participant was assigned.,Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex,"A Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex",COMPLETED,,PHASE3,207.0,ACTUAL,Entasis Therapeutics,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,INDUSTRY,,,,,,,2021,1.0
NCT05034562,,2020-06-10,,,2024-03-05,2021-09-02,2021-09-05,ACTUAL,,,,,,,2024-03-05,2024-03-07,ACTUAL,2022-09-26,ACTUAL,2022-09-26,2024-03,2024-03-31,2022-09-26,ACTUAL,2022-09-26,2022-09-26,ACTUAL,2022-09-26,,INTERVENTIONAL,,,Gallium-68 PSMA-11 PET in Participants With Prostate Cancer,Gallium-68 PSMA-11 PET in Participants With Prostate Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Per PI no participants enrolled,,,,,t,t,f,,,,,,,,,,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,OTHER,,,,,,,2022,0.0
NCT04361825,,2020-04-12,,,2023-12-29,2020-04-22,2020-04-24,ACTUAL,,,,,,,2023-12-29,2024-01-03,ACTUAL,2020-06-17,ACTUAL,2020-06-17,2023-12,2023-12-31,2023-10-25,ACTUAL,2023-10-25,2023-10-25,ACTUAL,2023-10-25,,INTERVENTIONAL,SUKSES-N4,,Durvalumab(MEDI4736) and AZD6738 Combination Therapy in Relapsed Small Cell Lung Cancer Subjects,"Phase Ⅱ, Single-arm Study of Durvalumab(MEDI4736) and AZD6738 Combination Therapy in Relapsed Small Cell Lung Cancer Subjects [SUKSES-N4]",COMPLETED,,PHASE2,42.0,ACTUAL,Samsung Medical Center,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 08:14:39.389798,2024-10-15 08:14:39.389798,OTHER,,,,,,,2023,1.0
NCT03427814,,2018-02-05,2023-08-24,2021-09-10,2023-08-24,2018-02-08,2018-02-09,ACTUAL,2023-08-24,2023-09-21,ACTUAL,2021-09-10,2021-09-14,ACTUAL,2023-08-24,2023-09-21,ACTUAL,2018-07-03,ACTUAL,2018-07-03,2023-08,2023-08-31,2023-01-03,ACTUAL,2023-01-03,2020-06-18,ACTUAL,2020-06-18,,INTERVENTIONAL,,Intent to Treat (ITT) Analysis Set included all randomized participants who were assigned to a study drug (pamiparib or placebo),Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer,"A Phase 2, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy",COMPLETED,,PHASE2,136.0,ACTUAL,BeiGene,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,INDUSTRY,,,,,,,2023,1.0
NCT03848065,,2019-02-19,2022-12-09,,2024-05-28,2019-02-19,2019-02-20,ACTUAL,2022-12-09,2023-10-11,ACTUAL,,,,2024-05-28,2024-06-11,ACTUAL,2019-04-02,ACTUAL,2019-04-02,2024-05,2024-05-31,2020-06-24,ACTUAL,2020-06-24,2020-06-24,ACTUAL,2020-06-24,,INTERVENTIONAL,,,"Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028)","A Phase I, Double-Blind, Randomized, Multicenter Trial of the Safety,Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants",COMPLETED,,PHASE1,133.0,ACTUAL,Merck Sharp & Dohme LLC,,3.0,,,f,,,,f,f,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,INDUSTRY,,,,,,,2020,1.0
NCT04222985,,2020-01-07,,,2022-10-21,2020-01-07,2020-01-10,ACTUAL,,,,,,,2022-10-21,2022-10-25,ACTUAL,2020-02-18,ACTUAL,2020-02-18,2022-10,2022-10-31,2021-05-19,ACTUAL,2021-05-19,2021-05-19,ACTUAL,2021-05-19,,INTERVENTIONAL,HSV15,,Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2,Safety and Efficacy of 4 Investigational HSV 2 Vaccines Administered by Intramuscular Route in Adults With Recurrent Genital Herpes Caused by HSV 2,TERMINATED,,PHASE1,24.0,ACTUAL,Sanofi,,20.0,,business reasons-Phase 2/Part B not conducted. Study terminated after last patient enrolled in Phase 1/Part A,f,,,,f,t,f,,,f,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,INDUSTRY,,,,,,,2021,0.0
NCT04203498,,2019-12-17,2024-02-09,,2024-04-15,2019-12-17,2019-12-18,ACTUAL,2024-04-15,2024-05-08,ACTUAL,,,,2024-04-15,2024-05-08,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2024-04,2024-04-30,2023-02-28,ACTUAL,2023-02-28,2023-02-10,ACTUAL,2023-02-10,,INTERVENTIONAL,RELEASE MSS3,Baseline characteristics are reported from the Full Analysis Set defined as all patients from the Safety Analysis Set who signed the informed consent and are randomized by interactive response technology.,Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis,"A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients With Spasticity Due to Multiple Sclerosis",TERMINATED,,PHASE3,139.0,ACTUAL,Jazz Pharmaceuticals,Study enrollment was ended early and did not reach the planned number of participants.,2.0,,This study was terminated based on a business decision by the Sponsor.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,INDUSTRY,,,,,,,2023,0.0
NCT02214407,,2014-07-30,,,2021-11-17,2014-08-08,2014-08-12,ESTIMATED,,,,,,,2021-11-17,2021-11-19,ACTUAL,2014-10-14,ACTUAL,2014-10-14,2021-11,2021-11-30,2021-08-16,ACTUAL,2021-08-16,2021-07-05,ACTUAL,2021-07-05,,INTERVENTIONAL,GFM-DAC-CMML,,Randomized Phase III Study of Decitabine +/- Hydroxyurea (HY) Versus HY in Advanced Proliferative CMML,A Randomized Phase III Study of Decitabine (DAC) With or Without Hydroxyurea (HY) Versus HY in Patients With Advanced Proliferative Chronic Myelomonocytic Leukemia (CMML),COMPLETED,,PHASE3,170.0,ACTUAL,Groupe Francophone des Myelodysplasies,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,OTHER,,,,,,,2021,0.0
NCT02846545,,2016-07-22,2022-05-18,2020-05-19,2022-12-20,2016-07-22,2016-07-27,ESTIMATED,2022-07-08,2022-07-14,ACTUAL,2020-05-19,2020-05-21,ACTUAL,2022-12-20,2022-12-22,ACTUAL,2016-08-26,ACTUAL,2016-08-26,2022-12,2022-12-31,2021-01-05,ACTUAL,2021-01-05,2019-05-21,ACTUAL,2019-05-21,,INTERVENTIONAL,T1GER,,A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes,SIMPONI® to Arrest β-cell Loss in Type 1 Diabetes,COMPLETED,,PHASE2,84.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,INDUSTRY,,,,,,,2021,1.0
NCT02992964,,2016-12-02,,,2024-04-01,2016-12-12,2016-12-14,ESTIMATED,,,,,,,2024-04-01,2024-04-02,ACTUAL,2017-05-15,ACTUAL,2017-05-15,2024-04,2024-04-30,2023-11-20,ACTUAL,2023-11-20,2023-11-20,ACTUAL,2023-11-20,,INTERVENTIONAL,,,Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers,Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers,TERMINATED,,PHASE1/PHASE2,11.0,ACTUAL,The Hospital for Sick Children,,1.0,,Withdrawal of drug supply/funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,OTHER,,,,,,,2023,0.0
NCT02213042,,2014-08-07,2021-06-01,2021-05-03,2021-09-17,2014-08-07,2014-08-11,ESTIMATED,2021-08-20,2021-09-16,ACTUAL,2021-05-04,2021-05-07,ACTUAL,2021-09-17,2021-10-13,ACTUAL,2014-10-24,ACTUAL,2014-10-24,2021-09,2021-09-30,2020-06-04,ACTUAL,2020-06-04,2020-06-04,ACTUAL,2020-06-04,,INTERVENTIONAL,,"Full Analysis Set (FAS): Consisted of all subjects who were randomized to study Arm A or Arm B or assigned to study Arm C, irrespective of whether they actually received study treatment.",Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer,"An Open-Label, Phase II, Study to Evaluate Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer Receiving Treatment With Trastuzumab in Combination With Lapatinib or Chemotherapy (EGF117165)",TERMINATED,,PHASE2,42.0,ACTUAL,Novartis,,3.0,,Primary analysis was completed in 2018 and continued minimal data collection from the one participant active in the study was not expected to add meaningful knowledge to the understanding of lapatinib,f,,,,f,t,f,,,,,,,,http://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,INDUSTRY,,,,,,,2020,0.0
NCT02450539,,2015-05-19,2018-03-30,,2021-07-26,2015-05-19,2015-05-21,ESTIMATED,2018-05-25,2018-06-26,ACTUAL,,,,2021-07-26,2021-08-13,ACTUAL,2015-08-06,ACTUAL,2015-08-06,2021-07-15,2021-07-15,2020-07-29,ACTUAL,2020-07-29,2017-03-31,ACTUAL,2017-03-31,,INTERVENTIONAL,,All randomized participants.,A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer,A Randomized Phase 2 Study of Abemaciclib (LY2835219) Versus Docetaxel in Patients With Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy,COMPLETED,,PHASE2,159.0,ACTUAL,Eli Lilly and Company,,2.0,,,t,,,,f,,,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,INDUSTRY,,NCT03763604,AVAILABLE,,,,2020,1.0
NCT03856099,,2019-02-21,,,2022-08-15,2019-02-25,2019-02-27,ACTUAL,,,,,,,2022-08-15,2022-08-18,ACTUAL,2019-11-13,ACTUAL,2019-11-13,2022-08,2022-08-31,2022-07-15,ACTUAL,2022-07-15,2022-07-15,ACTUAL,2022-07-15,,INTERVENTIONAL,,,TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab,"A Multicenter, Open-Label, Phase Ⅱ Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients With Recurrent Glioblastoma Progressed on Bevacizumab Including Therapy",TERMINATED,,PHASE2,19.0,ACTUAL,PharmAbcine,,1.0,,Subject recruitment issues and follow-up study plans,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 18:03:23.937454,2024-10-15 18:03:23.937454,INDUSTRY,,,,,,,2022,0.0
NCT03468829,,2018-03-07,,,2019-03-08,2018-03-12,2018-03-19,ACTUAL,,,,,,,2019-03-08,2019-03-11,ACTUAL,2019-02,ESTIMATED,2019-02-28,2019-03,2019-03-31,2020-05,ESTIMATED,2020-05-31,2020-05,ESTIMATED,2020-05-31,,INTERVENTIONAL,,,Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection,"A Randomized, Double-blind, Multicenter Study to Evaluate the Efficacy and Safety of ALX 0171 Versus Placebo, in Addition to Standard of Care, in Adults Who Have Undergone Hematopoietic Stem Cell Transplantation and Present With a Respiratory Syncytial Virus Respiratory Tract Infection",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Ablynx, a Sanofi company",,3.0,,ALX-0171 development program was stopped,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,INDUSTRY,,,,,,,2020,0.0
NCT03296098,,2017-09-22,,,2019-10-07,2017-09-27,2017-09-28,ACTUAL,,,,,,,2019-10-07,2019-10-09,ACTUAL,2020-12,ESTIMATED,2020-12-31,2019-10,2019-10-31,2022-12,ESTIMATED,2022-12-31,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,CCN013B,,Study of the Safety and Efficacy of Ulipristal Acetate (UPA) Used Daily as a Contraceptive,"A Multi-center, Open-label, Non-comparative Study of the Safety and Contraceptive Efficacy of Continuous Daily Oral 10 mg of Ulipristal Acetate (UPA)",SUSPENDED,,PHASE2,300.0,ESTIMATED,Health Decisions,,1.0,,Awaiting FDA approval to continue,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,OTHER,,,,,,,2022,0.0
NCT02609828,,2015-10-26,2021-10-25,2021-06-03,2023-01-25,2015-11-17,2015-11-20,ESTIMATED,2022-12-21,2023-01-20,ACTUAL,2021-06-03,2021-06-11,ACTUAL,2023-01-25,2023-02-16,ACTUAL,2015-10-28,ACTUAL,2015-10-28,2023-01,2023-01-31,2021-06-25,ACTUAL,2021-06-25,2020-09-17,ACTUAL,2020-09-17,,INTERVENTIONAL,,"The safety analysis set included all participants treated with tanezumab or placebo SC, including participants who received tanezumab 10 mg prior to protocol amendment 3.",Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy,"A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB (PF-04383119) IN SUBJECTS WITH CANCER PAIN PREDOMINANTLY DUE TO BONE METASTASIS RECEIVING BACKGROUND OPIOID THERAPY",COMPLETED,,PHASE3,156.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,INDUSTRY,,,,,,,2021,1.0
NCT01897714,,2013-07-09,2020-06-29,,2020-10-22,2013-07-11,2013-07-12,ESTIMATED,2020-08-07,2020-08-24,ACTUAL,,,,2020-10-22,2020-10-23,ACTUAL,2013-07,ACTUAL,2013-07-31,2020-10,2020-10-31,2020-03,ACTUAL,2020-03-31,2017-12,ACTUAL,2017-12-31,,INTERVENTIONAL,,"The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.",Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients,An Open-Label Phase I/IIa Study of the Safety and Efficacy of Melphalan-flufenamide (Melflufen) and Dexamethasone Combination for Patients With Relapsed and/or Relapsed-Refractory Multiple Myeloma,TERMINATED,,PHASE1/PHASE2,75.0,ACTUAL,Oncopeptides AB,Study is terminated and long-term follow-up ended due to Sponsor decision.,6.0,,The study was terminated at median 46-48 months long term follow-up and mature overall survival follow-up data.,f,,,,t,,,,,,,,,,,,,2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,INDUSTRY,,,,,,,2020,0.0
NCT04516603,,2020-08-11,,,2020-10-13,2020-08-13,2020-08-18,ACTUAL,,,,,,,2020-10-13,2020-10-19,ACTUAL,2020-10-01,ESTIMATED,2020-10-01,2020-10,2020-10-31,2021-12-31,ESTIMATED,2021-12-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,Fampyr_2020,,Influence of Fampridine on Working Memory in Healthy Subjects,Randomized Placebo-controlled Phase II Cross-over Study on the Influence of Fampridine on Working Memory in Healthy Subjects,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Basel,,2.0,,Changement of study design. Restart spring 2021.,f,,,,f,f,f,,,,,,"IPD will be available after publication, study protocol (including statistical analysis plan) will be made available before start of the study.",All IPD (de-identified) that underlie results in a publication will be shared upon reasonable request for scientific purposes. A reasonable request consists of a short description of the scientific purpose. Requests will be reviewed by the team of the principle investigator.,,YES,All IPD (de-identified) that underlie results in a publication will be shared upon reasonable request.,2024-10-15 18:03:23.937454,2024-10-15 18:03:23.937454,OTHER,,,,,,,2021,0.0
NCT04607980,,2020-10-23,2023-11-23,2022-11-18,2023-11-23,2020-10-23,2020-10-29,ACTUAL,2023-11-23,2023-12-15,ACTUAL,2022-11-18,2022-11-22,ACTUAL,2023-11-23,2023-12-15,ACTUAL,2020-11-11,ACTUAL,2020-11-11,2023-11,2023-11-30,2022-06-03,ACTUAL,2022-06-03,2022-01-13,ACTUAL,2022-01-13,,INTERVENTIONAL,,Full Analysis Set (FAS): consisted of all randomized participants.,A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis,"A Phase 3, Multicenter, Randomized, Double-Blind Study Evaluating the Efficacy and Safety of ABP 654 Compared With Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis",COMPLETED,,PHASE3,563.0,ACTUAL,Amgen,"Due to non-convergence of the generalized linear model used for pre-specified analyses, ad hoc analyses were conducted for efficacy endpoints of PASI 75 response, PASI 100 response, and sPGA response.",2.0,,,,,,,t,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,INDUSTRY,,,,,,,2022,0.0
NCT02908451,,2016-09-06,,,2021-07-08,2016-09-16,2016-09-21,ESTIMATED,,,,,,,2021-07-08,2021-07-13,ACTUAL,2017-04-24,ACTUAL,2017-04-24,2020-07,2020-07-31,2021-02-28,ACTUAL,2021-02-28,2021-02-28,ACTUAL,2021-02-28,,INTERVENTIONAL,,,"A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer","A Phase I Dose Escalation Study, With Cohort Expansion, to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AbGn-107 Therapy in Patients With Chemo-refractory Locally Advanced, Recurrent, or Metastatic Gastric, Colorectal, Pancreatic or Biliary Cancer",TERMINATED,,PHASE1,39.0,ACTUAL,AbGenomics B.V Taiwan Branch,,1.0,,"COVID-19 pandemic has caused a huge operational difficulty for this ongoing clinical trial, as many hospitals have set limitations on onsite staff, patient visits, study related procedures and onsite monitoring visits.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,INDUSTRY,,,,,,,2021,0.0
NCT03529331,,2018-05-07,,,2019-04-19,2018-05-07,2018-05-18,ACTUAL,,,,,,,2019-04-19,2019-04-23,ACTUAL,2019-09-01,ESTIMATED,2019-09-01,2019-04,2019-04-30,2021-12-31,ESTIMATED,2021-12-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,"A Study Comparing Recurrent Use of MSIR, Percocet, and Vicodin at Discharge From the ED","A Study Comparing Recurrent Use of Morphine Sulfate Immediate Release, Oxycodone/Acetaminophen (Percocet), and Hydrocodone/Acetaminophen (Vicodin) at Discharge From the ED in Opioid-naïve Adult Patients With Moderate to Severe Pain.",WITHDRAWN,,PHASE4,0.0,ACTUAL,Maimonides Medical Center,,3.0,,The ED physicians no longer prescribe opioids at discharge; not feasible to conduct the study,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,OTHER,,,,,,,2021,0.0
NCT02477839,,2015-05-13,2021-05-27,,2021-06-30,2015-06-22,2015-06-23,ESTIMATED,2021-06-30,2021-07-01,ACTUAL,,,,2021-06-30,2021-07-01,ACTUAL,2015-06-05,ACTUAL,2015-06-05,2021-06,2021-06-30,2020-05-28,ACTUAL,2020-05-28,2020-05-28,ACTUAL,2020-05-28,,INTERVENTIONAL,,Baseline Characteristics refer to the Safety Set (SS) which consisted of all randomized study participants who took at least 1 dose of study medication.,Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures,"A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects With Epilepsy >=1 Month to <4 Years of Age With Partial-Onset Seizures",COMPLETED,,PHASE3,255.0,ACTUAL,UCB Pharma,,2.0,,,t,,,,t,,,,,,,,,,,,,2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,INDUSTRY,,NCT03559673,NO_LONGER_AVAILABLE,,,,2020,1.0
NCT03773562,,2018-11-27,2023-06-26,,2023-12-18,2018-12-10,2018-12-12,ACTUAL,2023-12-18,2024-01-09,ACTUAL,,,,2023-12-18,2024-01-09,ACTUAL,2019-03-25,ACTUAL,2019-03-25,2023-12,2023-12-31,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,,Imaging the Migraine Brain Pre- and Post-Erenumab,Imaging the Migraine Brain Pre- and Post-Erenumab: an MRI Study to Identify Functional and Structural Changes That Correlate With Patient Improvement,COMPLETED,,PHASE4,50.0,ACTUAL,Mayo Clinic,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2022,1.0
NCT05250856,,2022-02-11,,,2023-12-14,2022-02-11,2022-02-22,ACTUAL,,,,,,,2023-12-14,2023-12-20,ACTUAL,2022-03-14,ACTUAL,2022-03-14,2023-12,2023-12-31,2023-12-12,ACTUAL,2023-12-12,2023-12-12,ACTUAL,2023-12-12,,INTERVENTIONAL,,,CNP-201 in Subjects With Peanut Allergy,"A Phase 1b/2a Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of CNP-201 in Subjects Ages 16-55 With Peanut Allergy",TERMINATED,,PHASE1,15.0,ACTUAL,"COUR Pharmaceutical Development Company, Inc.",,5.0,,Lagging Enrollment and Administrative Reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,INDUSTRY,,,,,,,2023,0.0
NCT02856698,,2016-07-20,2021-05-14,,2022-05-20,2016-08-02,2016-08-05,ESTIMATED,2022-03-03,2022-05-19,ACTUAL,,,,2022-05-20,2022-06-09,ACTUAL,2017-04-08,ACTUAL,2017-04-08,2022-05,2022-05-31,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,MIMO,All quantitative and categorical variables were expressed as median (interquartile range) and n (%) and were compared using the Mann-Whitney U test and Fisher's exact test respectively.,MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial),"Study Design and Rationale of A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema: MIMO Trial",TERMINATED,,PHASE4,111.0,ACTUAL,Hospital Universitario de Canarias,"The main limitation of the study was that the study treatment, because it was a serious pathology, was sometimes administered in the ambulance, before admission to the hospital emergency room.~Another limitation has been the COVID-19 pandemic",2.0,,The study was stopped because of the adverse events,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,OTHER,,,,,,,2020,0.0
NCT04208997,,2019-12-19,2022-08-17,,2022-10-19,2019-12-20,2019-12-23,ACTUAL,2022-10-19,2022-11-14,ACTUAL,,,,2022-10-19,2022-11-14,ACTUAL,2019-12-19,ACTUAL,2019-12-19,2022-10,2022-10-31,2021-06-30,ACTUAL,2021-06-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,AFTER-VT,,Continuation of Antiarrhythmics Following Ventricular Tachycardia Catheter Ablation,Continuation of Antiarrhythmics Following caThEteR Ablation for Ventricular Tachycardia (AFTER-VT) Trial: A Pilot Randomized Clinical Trial,TERMINATED,,PHASE3,5.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,Study was terminated due to low accrual,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,OTHER,,,,,,,2021,0.0
NCT04573218,,2020-09-28,,,2022-04-05,2020-09-28,2020-10-05,ACTUAL,,,,,,,2022-04-05,2022-04-13,ACTUAL,2021-10-18,ACTUAL,2021-10-18,2022-04,2022-04-30,2021-12-20,ACTUAL,2021-12-20,2021-12-16,ACTUAL,2021-12-16,,INTERVENTIONAL,,,Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Subjects With Minor Hyperlipidaemia,Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Subjects With Minor Hyperlipidaemia (Phase 2 Clinical Trial Study),COMPLETED,,PHASE2,50.0,ACTUAL,National University of Malaysia,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,OTHER,,,,,,,2021,1.0
NCT04773600,,2021-02-24,2024-08-06,2023-09-12,2024-09-24,2021-02-24,2021-02-26,ACTUAL,2024-09-24,2024-10-04,ACTUAL,,2024-10-04,ACTUAL,2024-09-24,2024-10-04,ACTUAL,2021-02-24,ACTUAL,2021-02-24,2024-09,2024-09-30,2022-09-29,ACTUAL,2022-09-29,2022-09-29,ACTUAL,2022-09-29,,INTERVENTIONAL,,,Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II),"A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects With Atopic Dermatitis",COMPLETED,,PHASE3,683.0,ACTUAL,"Arcutis Biotherapeutics, Inc.",,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,INDUSTRY,,,,,,,2022,1.0
NCT05254808,,2022-02-14,,,2022-02-27,2022-02-14,2022-02-24,ACTUAL,,,,,,,2022-02-27,2022-03-15,ACTUAL,2021-09-06,ACTUAL,2021-09-06,2022-02,2022-02-28,2022-02-14,ACTUAL,2022-02-14,2022-02-14,ACTUAL,2022-02-14,,INTERVENTIONAL,EXFOCY,,EXtended Use of FOsfomycin for the Treatment of CYstitis in Primary Care,EXtended Use of FOsfomycin for the Treatment of CYstitis in Primary Care,TERMINATED,,PHASE3,13.0,ACTUAL,UMC Utrecht,,3.0,,"Insufficient participating sites, and insufficient participants from participating sites mainly due to COVID-19 workload. The number of necessary participants could not be reached within the anticipated timelines and the allocated budget.",f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,OTHER,,,,,,,2022,0.0
NCT03275792,,2017-08-29,,,2020-11-05,2017-09-05,2017-09-08,ACTUAL,,,,,,,2020-11-05,2020-11-09,ACTUAL,2020-05,ESTIMATED,2020-05-31,2019-09,2019-09-30,2021-04,ESTIMATED,2021-04-30,2021-04,ESTIMATED,2021-04-30,,INTERVENTIONAL,,,Shiga Toxin Producing Escherichia Coli (STEC) Volume Expansion,Inpatient Volume Expansion in Children With Shiga Toxin-Producing Escherichia Coli (STEC) Infection to Prevent Hemolytic Uremic Syndrome (HUS),WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Calgary,,2.0,,Funding not obtained.,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,OTHER,,,,,,,2021,0.0
NCT03449147,,2018-02-22,2021-08-09,,2021-08-09,2018-02-22,2018-02-28,ACTUAL,2021-08-09,2021-09-02,ACTUAL,,,,2021-08-09,2021-09-02,ACTUAL,2018-03-15,ACTUAL,2018-03-15,2021-08,2021-08-31,2020-10-30,ACTUAL,2020-10-30,2020-08-20,ACTUAL,2020-08-20,,INTERVENTIONAL,,,A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030),"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN030)",COMPLETED,,PHASE3,1317.0,ACTUAL,Merck Sharp & Dohme LLC,,3.0,,,,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,INDUSTRY,,,,,,,2020,1.0
NCT03532958,,2018-05-10,,,2022-09-14,2018-05-10,2018-05-22,ACTUAL,,,,,,,2022-09-14,2022-09-16,ACTUAL,2021-10,ESTIMATED,2021-10-31,2022-09,2022-09-30,2022-11,ESTIMATED,2022-11-30,2022-11,ESTIMATED,2022-11-30,,INTERVENTIONAL,,,Phase 2 Trial of BNZ-1 in Patients With Moderate to Severe Alopecia Areata,"A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of Intravenous BNZ-1 in Patients With Moderate to Severe Alopecia Areata",WITHDRAWN,,PHASE2,0.0,ACTUAL,Equillium,,3.0,,Transfer of study sponsor,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-15 08:20:22.562977,2024-10-15 08:20:22.562977,INDUSTRY,,,,,,,2022,0.0
NCT03990571,,2019-06-17,2024-03-05,,2024-07-31,2019-06-17,2019-06-19,ACTUAL,2024-07-31,2024-08-26,ACTUAL,,,,2024-07-31,2024-08-26,ACTUAL,2019-07-22,ACTUAL,2019-07-22,2024-07,2024-07-31,2023-03-20,ACTUAL,2023-03-20,2023-03-20,ACTUAL,2023-03-20,,INTERVENTIONAL,,"40 participants enrolled from July 2019 to June 2021 (6 were screen failures), 34 were treated and 6 of the 34 were evaluable for safety only and did not undergo the first re-staging imaging assessment",Axitinib and Avelumab in Treating Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma,A Phase 2 Clinical Trial of Axitinib and Avelumab in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma (ACC),COMPLETED,,PHASE2,40.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,,,,,f,t,f,,,,,,,,,,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2023,1.0
NCT03208127,,2017-07-03,2022-05-20,,2022-07-27,2017-07-03,2017-07-05,ACTUAL,2022-07-27,2022-07-28,ACTUAL,,,,2022-07-27,2022-07-28,ACTUAL,2017-11-21,ACTUAL,2017-11-21,2022-07,2022-07-31,2021-06-04,ACTUAL,2021-06-04,2021-06-04,ACTUAL,2021-06-04,,INTERVENTIONAL,,Baseline Analysis population is number of consented subjects initiating Direct Antiviral Treatment,DAA Treatment in Donor HCV-positive to Recipient HCV-negative Liver Transplant,Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Liver Transplant,TERMINATED,,PHASE4,33.0,ACTUAL,Massachusetts General Hospital,Protocol transitioned out of research to standard of care and was closed prior to completion and planned enrollment goal was not met. Review of data from enrolled patient was used for reporting purposes and data is primarily descriptive and not based on statistical analysis.,1.0,,"Protocol transitioned to standard of care, no funding available to continue support of research work or data analysis",f,,,,f,t,f,,,f,,,Anticipated that data from the study will become available within 6 months after the final patient completes the primary study endpoint (12 weeks post treatment),Data would only be shared with Institutional Review Board (IRB) approved collaborators.,,YES,Coded data is anticipated to be shared with potential collaborators.,2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,OTHER,,,,,,,2021,0.0
NCT03475680,,2018-03-09,,,2022-05-12,2018-03-16,2018-03-23,ACTUAL,,,,,,,2022-05-12,2022-05-17,ACTUAL,2018-08-08,ACTUAL,2018-08-08,2022-05,2022-05-31,2022-03-23,ACTUAL,2022-03-23,2021-08-26,ACTUAL,2021-08-26,,INTERVENTIONAL,COLONPREP,,Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery,Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (COLONPREP Study),TERMINATED,,PHASE3,193.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,4.0,,lack of inclusions,f,,,,f,f,f,,,,,,,,,NO,There is not a plan to make IPD available,2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,OTHER,,,,,,,2022,0.0
NCT03835871,,2019-02-07,,,2019-07-15,2019-02-07,2019-02-11,ACTUAL,,,,,,,2019-07-15,2019-07-17,ACTUAL,2019-02,ESTIMATED,2019-02-28,2019-07,2019-07-31,2020-05,ESTIMATED,2020-05-31,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,Beclomethasone Dipropionate HFA in Adult and Adolescent Subjects With Mild to Moderate Persistent Asthma,"A Randomized, Parallel Group, Multicenter, Double -Blind, Double-dummy, Placebo-controlled Phase 3 Study With Beclomethasone Dipropionate HFA at 100 μg, 200 μg and 400 μg Daily Doses Compared to Placebo in Mild or Moderate Persistent Asthma",WITHDRAWN,,PHASE3,0.0,ACTUAL,Adamis Pharmaceuticals Corporation,,4.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,INDUSTRY,,,,,,,2020,0.0
NCT03973333,,2019-05-23,,,2024-03-06,2019-05-31,2019-06-04,ACTUAL,,,,,,,2024-03-06,2024-03-07,ACTUAL,2019-05-17,ACTUAL,2019-05-17,2024-03,2024-03-31,2023-09-25,ACTUAL,2023-09-25,2023-09-25,ACTUAL,2023-09-25,,INTERVENTIONAL,,,Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab,A Phase 1/2 First-in-human Study of the Safety and Efficacy of IMC-C103C as Single Agent and in Combination With Atezolizumab in HLA-A*0201-positive Patients With Advanced MAGE-A4-positive Cancer,TERMINATED,,PHASE1/PHASE2,75.0,ACTUAL,Immunocore Ltd,,4.0,,The Sponsor terminated the study and there is no further enrollment. Endpoints will not be assessed for this trial.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,INDUSTRY,,,,,,,2023,0.0
NCT03602339,,2018-07-17,2021-03-08,,2021-05-20,2018-07-18,2018-07-26,ACTUAL,2021-04-02,2021-04-28,ACTUAL,,,,2021-05-20,2021-06-14,ACTUAL,2018-11-14,ACTUAL,2018-11-14,2021-05,2021-05-31,2020-05-26,ACTUAL,2020-05-26,2020-03-13,ACTUAL,2020-03-13,,INTERVENTIONAL,LEADER 75,,Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose,LowEr Administered Dose With highEr Relaxivity: Gadovist vs Dotarem (LEADER 75),COMPLETED,,PHASE4,157.0,ACTUAL,Bayer,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,INDUSTRY,,,,,,,2020,1.0
NCT04232449,,2020-01-14,,,2024-07-02,2020-01-14,2020-01-18,ACTUAL,,,,,,,2024-07-02,2024-07-03,ACTUAL,2020-11-06,ACTUAL,2020-11-06,2024-07,2024-07-31,2024-04-30,ACTUAL,2024-04-30,2024-04-30,ACTUAL,2024-04-30,,INTERVENTIONAL,OSPIC,,Oral Corticosteroids for Post-infectious Cough in Adults,Oral Corticosteroids for Post-infectious Cough in Adults: A Double-blind Randomised Placebo-controlled Trial in Swiss Family Practices (OSPIC Trial),TERMINATED,,PHASE3,32.0,ACTUAL,"University Hospital, Basel, Switzerland",,2.0,,too few patients were included,f,,,,f,f,f,,,,,,,,,,,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,OTHER,,,,,,,2024,0.0
NCT04252417,,2020-01-31,,,2020-05-11,2020-01-31,2020-02-05,ACTUAL,,,,,,,2020-05-11,2020-05-13,ACTUAL,2019-10-11,ACTUAL,2019-10-11,2020-01,2020-01-31,2020-03-17,ACTUAL,2020-03-17,2020-03-17,ACTUAL,2020-03-17,,INTERVENTIONAL,,,HI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Hepatic Impaired Patients and Healthy Subjects,"Open Label, Phase I Study to Assess and Compare the Pharmacokinetic Parameters After Single Oral Administration of MD1003 100 mg in Hepatic Impaired Patients and Healthy Subjects With Normal Hepatic Function",TERMINATED,,PHASE1,15.0,ACTUAL,MedDay Pharmaceuticals SA,,2.0,,Due to other Phase 3 trial failure to meet primary endpoint,f,,,,f,f,f,,,,,,,,,,,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,INDUSTRY,,,,,,,2020,0.0
NCT05085574,,2021-10-07,,,2023-10-05,2021-10-18,2021-10-20,ACTUAL,,,,,,,2023-10-05,2023-10-10,ACTUAL,2023-02-07,ACTUAL,2023-02-07,2023-10,2023-10-31,2023-02-07,ACTUAL,2023-02-07,2023-02-07,ACTUAL,2023-02-07,,INTERVENTIONAL,,,Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) in Hospitalized Patients With COVID-19 (Addendum 1),"A Phase 2 Randomized, Single-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of the Combination of Famotidine and Celecoxib as a Treatment in Moderate-to-severe Patients Hospitalized for COVID-19",WITHDRAWN,,PHASE2,0.0,ACTUAL,Leidos Life Sciences,,2.0,,"COVID environment, lack of site confidence to enroll subjects, sites not suited to study procedures, decline of potential inpatient subjects at site",f,,,,t,t,f,,,,,,,,,UNDECIDED,It is not yet known if there will be a plan to make individual participant data (IPD) available.,2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,INDUSTRY,,,,,,,2023,0.0
NCT02000934,,2013-11-18,,,2023-02-06,2013-11-26,2013-12-04,ESTIMATED,,,,,,,2023-02-06,2023-02-08,ACTUAL,2013-12-31,,2013-12-31,2023-02,2023-02-28,2021-06-29,ACTUAL,2021-06-29,2021-06-29,ACTUAL,2021-06-29,,INTERVENTIONAL,,,A Study of TAK-659 in Adult Participants With Advanced Solid Tumor and Lymphoma Malignancies,"An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-659 in Adult Patients With Advanced Solid Tumor and Lymphoma Malignancies",COMPLETED,,PHASE1,143.0,ACTUAL,"Calithera Biosciences, Inc",,9.0,,,f,,,,f,,,,,,,,,,,YES,"Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,INDUSTRY,,,,,,,2021,1.0
NCT05614453,,2022-11-03,,,2023-06-28,2022-11-09,2022-11-14,ACTUAL,,,,,,,2023-06-28,2023-06-29,ACTUAL,2023-06,ESTIMATED,2023-06-30,2023-06,2023-06-30,2023-06-28,ACTUAL,2023-06-28,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,ITTACC,,Tislelizumab in Combination With Sitravatinib for Recurrent/Metastatic Cervical Cancer After Platinum-Based Chemotherapy,A Phase II Trial of Tislelizumab in Combination With Sitravatinib for Recurrent/Metastatic Cervical Cancer After Platinum-Based Chemotherapy,WITHDRAWN,,PHASE2,0.0,ACTUAL,Australia New Zealand Gynaecological Oncology Group,,1.0,,BeiGene has withdrawn their support owing to sitravatinib supply concerns. Mirati is ceasing further development of sitravatinib owing to the negative results of the SAPPHIRE trial which used sitravatinib in 2nd line met NSCLC setting.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 16:13:18.027461,2024-10-16 16:13:18.027461,OTHER,,,,,,,2023,0.0
NCT02877134,,2016-08-19,2021-12-10,,2023-01-23,2016-08-19,2016-08-24,ESTIMATED,2022-01-27,2022-02-17,ACTUAL,,,,2023-01-23,2023-02-17,ACTUAL,2016-08-25,ACTUAL,2016-08-25,2023-01,2023-01-31,2022-01-24,ACTUAL,2022-01-24,2020-12-10,ACTUAL,2020-12-10,,INTERVENTIONAL,TRIDENT,,Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease,"A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease",COMPLETED,,PHASE2,388.0,ACTUAL,"Janssen Research & Development, LLC",,7.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,INDUSTRY,,,,,,,2022,0.0
NCT04484428,,2020-07-20,,2022-03-11,2022-03-11,2020-07-20,2020-07-23,ACTUAL,,,,,,,2022-03-11,2022-03-16,ACTUAL,2020-08-15,ACTUAL,2020-08-15,2022-03,2022-03-31,2021-03-19,ACTUAL,2021-03-19,2021-03-19,ACTUAL,2021-03-19,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle Soreness (DOMS) in the Lower Extremity,"A Phase II, Randomized, Double-blind, Active Comparator, Parallel Group Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle Soreness (DOMS) in the Lower Extremity",TERMINATED,,PHASE2,126.0,ACTUAL,"Kowa Research Institute, Inc.",,2.0,,Internal business decision,f,,,,f,t,f,,,,,,,,,,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,INDUSTRY,,,,,,,2021,0.0
NCT02978222,,2016-11-22,2022-08-22,,2022-11-21,2016-11-28,2016-11-30,ESTIMATED,2022-11-21,2022-12-15,ACTUAL,,,,2022-11-21,2022-12-15,ACTUAL,2017-07-20,ACTUAL,2017-07-20,2020-02,2020-02-29,2020-01-15,ACTUAL,2020-01-15,2020-01-15,ACTUAL,2020-01-15,,INTERVENTIONAL,,,Folate Receptor Alpha Peptide Vaccine With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer,"A Randomized Multicenter Phase II Trial to Evaluate the Safety, Efficacy and Immunogenicity of Vaccination With Folate Receptor Alpha Peptides With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer and a Response or Stable Disease to Platinum Therapy",TERMINATED,,PHASE2,120.0,ACTUAL,"Marker Therapeutics, Inc.","The trial was stopped due futility. Therefore, results are not for the complete study as designed.",2.0,,Futility analysis did not support continuation of the trial,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,INDUSTRY,,,,,,,2020,0.0
NCT04535362,,2020-08-24,2024-06-28,,2024-08-01,2020-08-31,2020-09-01,ACTUAL,2024-08-01,2024-08-26,ACTUAL,,,,2024-08-01,2024-08-26,ACTUAL,2021-06-28,ACTUAL,2021-06-28,2024-08,2024-08-31,2023-06-29,ACTUAL,2023-06-29,2023-06-29,ACTUAL,2023-06-29,,INTERVENTIONAL,,Participants randomized to one of two crossover arms.,Nicotine's Potential Abuse With Menthol,Impact of Menthol on the Abuse Potential of Nicotine,COMPLETED,,EARLY_PHASE1,16.0,ACTUAL,Yale University,,2.0,,,,,,,f,t,f,,,,,,,,,,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2023,1.0
NCT04467853,,2020-07-01,,,2023-08-11,2020-07-10,2020-07-13,ACTUAL,,,,,,,2023-08-11,2023-08-15,ACTUAL,2020-09-21,ACTUAL,2020-09-21,2023-08,2023-08-31,2023-07-17,ACTUAL,2023-07-17,2023-07-17,ACTUAL,2023-07-17,,INTERVENTIONAL,,,A Clinical Study to Evaluate CAR-T Cell-based Medicinal Product in the Treatment of Advanced Solid Tumors,"A Phase 1, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of LCAR-C18S, an CAR-T Cell Therapy Targeting Claudin18.2 in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1,34.0,ACTUAL,Shanghai East Hospital,,1.0,,Both the sponsors and collaborator are considering terminating the study,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2023,0.0
NCT03638011,,2018-07-09,2021-02-10,,2022-05-16,2018-08-16,2018-08-20,ACTUAL,2021-02-10,2021-03-03,ACTUAL,,,,2022-05-16,2022-06-07,ACTUAL,2018-09-25,ACTUAL,2018-09-25,2022-05,2022-05-31,2020-06-30,ACTUAL,2020-06-30,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,,A Comparison of the Post-C/S Analgesic Effects of Neuraxial Duramorph vs Bilateral TAP Block With Liposomal Bupivacaine,A Comparison of the Post-cesarean Section Analgesic Effects of Neuraxial Duramorph vs. Bilateral Transverse Abdominal Plane Block With Combined Bupivacaine/Liposomal Bupivacaine (Exparel),TERMINATED,,PHASE4,71.0,ACTUAL,Maimonides Medical Center,,2.0,,Standard of Care changed due to COVID-19 and thus had to stop the study.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,OTHER,,,,,,,2020,0.0
NCT02906332,,2016-05-26,2023-06-22,,2023-07-28,2016-09-14,2016-09-20,ESTIMATED,2023-07-28,2023-08-22,ACTUAL,,,,2023-07-28,2023-08-22,ACTUAL,2016-12-12,ACTUAL,2016-12-12,2023-07,2023-07-31,2022-05,ACTUAL,2022-05-31,2022-05,ACTUAL,2022-05-31,,INTERVENTIONAL,,,Pembrolizumab + Lenalidomide Post Autologous Stem Cell Transplant (ASCT) in High-risk Multiple Myeloma (MM),A Phase II Trial of the Anti -PD-1 Monoclonal Antibody Pembrolizumab (MK-3475) + Lenalidomide + Dexamethasone as Post Autologous Transplant Consolidation in Patients With High-risk Multiple Myeloma,TERMINATED,,PHASE2,12.0,ACTUAL,Hackensack Meridian Health,,1.0,,FDA Hold Due to Updated Risks,f,,,,t,,,,,,,,,,,NO,,2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,OTHER,,,,,,,2022,0.0
NCT01727401,,2012-11-08,,,2021-07-14,2012-11-12,2012-11-16,ESTIMATED,,,,,,,2021-07-14,2021-07-21,ACTUAL,2012-11,ACTUAL,2012-11-30,2021-07,2021-07-31,2021-07,ACTUAL,2021-07-31,2021-07,ACTUAL,2021-07-31,,INTERVENTIONAL,FAITH,,Thromboprophylaxis of Venous Thromboembolism in Acutely-ill Medical Inpatients With Thrombocytopenia,Thromboprophylaxis With Fondaparinux of Deep Vein Thrombosis and Pulmonary Embolism in the Acutely-ill Medical Inpatients With Thrombocytopenia,TERMINATED,,PHASE4,7.0,ACTUAL,G. d'Annunzio University,,1.0,,Slow recruitment rate,f,,,,t,,,,,,,,,,,,,2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,OTHER,,,,,,,2021,0.0
NCT03758443,,2018-11-19,2022-10-21,,2022-10-21,2018-11-27,2018-11-29,ACTUAL,2022-10-21,2022-11-15,ACTUAL,,,,2022-10-21,2022-11-15,ACTUAL,2019-03-11,ACTUAL,2019-03-11,2021-11,2021-11-30,2021-10-20,ACTUAL,2021-10-20,2021-10-20,ACTUAL,2021-10-20,,INTERVENTIONAL,RHEA,The Intent-to-treat population included all randomized participants.,Efficacy & Safety of TD-1473 in Ulcerative Colitis,"A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis",TERMINATED,,PHASE2/PHASE3,239.0,ACTUAL,Theravance Biopharma,"The study was terminated early due to a company decision based on interim analysis results in TD-1473-0157. Therefore, the Phase 3 dose-confirming Induction Study was not conducted and the Maintenance Study was prematurely terminated.",4.0,,Stopped early due to company decision. Company decision based on interim analysis results in TD-1473-0157.,f,,,,t,t,f,,,,,,,,,NO,"Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.",2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,INDUSTRY,,,,,,,2021,0.0
NCT04978493,,2021-07-26,,,2024-10-02,2021-07-26,2021-07-27,ACTUAL,,,,,,,2024-10-02,2024-10-03,ACTUAL,2021-10-04,ACTUAL,2021-10-04,2024-10,2024-10-31,2024-08-08,ACTUAL,2024-08-08,2024-07-08,ACTUAL,2024-07-08,,INTERVENTIONAL,,,A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease,"A Phase IIa, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BI 706321 Orally Administered for 12 Weeks in Patients With Crohn's Disease (CD) Receiving Ustekinumab Induction Treatment",TERMINATED,,PHASE2,49.0,ACTUAL,Boehringer Ingelheim,,2.0,,Company decision,f,,,,,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,INDUSTRY,,,,,,,2024,0.0
NCT02663908,,2016-01-22,2022-03-21,,2022-06-28,2016-01-22,2016-01-26,ESTIMATED,2022-06-28,2022-06-29,ACTUAL,,,,2022-06-28,2022-06-29,ACTUAL,2016-04-19,ACTUAL,2016-04-19,2022-05,2022-05-31,2021-03-29,ACTUAL,2021-03-29,2021-03-29,ACTUAL,2021-03-29,,INTERVENTIONAL,PRONOUNCE,The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.,A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease,"A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients With Prostate Cancer and Cardiovascular Disease Receiving Degarelix (Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist)",TERMINATED,,PHASE3,545.0,ACTUAL,Ferring Pharmaceuticals,"The trial was terminated prematurely due to a slower than anticipated recruitment rate and a lower than anticipated observed CV event rate. Approximately 900 patients were planned to be included, however, at the time of stopping screening and recruitment 216 patients had completed the trial, 292 were ongoing, and 37 were withdrawn. The Sponsor decision to stop the trial was not based on any safety concerns, any knowledge of the results, or influenced by issues imposed by the COVID-19 pandemic.",2.0,,"Recruitment rate; a lower than anticipated observed cardiovascular event rate. The Sponsor decision to stop the trial was not based on any safety concerns or any knowledge of the results, or influenced by issues imposed by the COVID-19 pandemic.",f,,,,t,,,,,,,,,,,,,2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,INDUSTRY,,,,,,,2021,0.0
NCT04322708,,2020-03-24,2023-12-13,,2023-12-13,2020-03-24,2020-03-26,ACTUAL,2023-12-13,2024-01-02,ACTUAL,,,,2023-12-13,2024-01-02,ACTUAL,2020-07-06,ACTUAL,2020-07-06,2023-12,2023-12-31,2022-01-18,ACTUAL,2022-01-18,2021-06-04,ACTUAL,2021-06-04,,INTERVENTIONAL,KRYPTOS,Modified Intention-to-treat,A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis,"A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab (AK002) in Adult and Adolescent Patients With Active Eosinophilic Esophagitis",COMPLETED,,PHASE2/PHASE3,277.0,ACTUAL,Allakos Inc.,,3.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,INDUSTRY,,,,,,,2022,1.0
NCT02282358,,2014-10-29,2023-11-02,,2024-03-07,2014-10-31,2014-11-04,ESTIMATED,2024-03-07,2024-03-08,ACTUAL,,,,2024-03-07,2024-03-08,ACTUAL,2014-10,ACTUAL,2014-10-31,2023-05,2023-05-31,2023-05-26,ACTUAL,2023-05-26,2023-05-26,ACTUAL,2023-05-26,,INTERVENTIONAL,,,Study of Mocetinostat in Selected Patients With Mutations of Acetyltransferase Genes in Relapsed and Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma,An Open-Label Phase II Study of Mocetinostat in Selected Patients With Mutations of Acetyltransferase Genes in Relapsed and Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma,TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,Lack of accrual,f,,,,,,,,,,,,,,,,,2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,OTHER,,,,,,,2023,0.0
NCT05318443,,2022-03-22,,,2023-12-24,2022-04-07,2022-04-08,ACTUAL,,,,,,,2023-12-24,2023-12-27,ACTUAL,2020-04-17,ACTUAL,2020-04-17,2023-09,2023-09-30,2023-01-12,ACTUAL,2023-01-12,2022-12-26,ACTUAL,2022-12-26,,INTERVENTIONAL,,,A Study Exploring Efficacy of SIBP04 in Subjects With Non-squamous Non-small Cell Lung Cancer,"A Randomized, Double-blind, Parallel-controlled Study Comparing the Efficacy and Safety of Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection (SIBP04) and Bevacizumab Injection (Avastin) in Combination With Paclitaxel and Carboplatin Respectively in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer.",COMPLETED,,PHASE3,512.0,ACTUAL,Shanghai Institute Of Biological Products,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,INDUSTRY,,,,,,,2023,1.0
NCT04035109,,2019-07-24,,,2022-06-07,2019-07-24,2019-07-29,ACTUAL,,,,,,,2022-06-07,2022-06-08,ACTUAL,2019-12-16,ACTUAL,2019-12-16,2022-06,2022-06-30,2023-10,ESTIMATED,2023-10-31,2022-10,ESTIMATED,2022-10-31,,INTERVENTIONAL,,,Anakinra as a Rescue Treatment for Allergic Inflammation,Anakinra as a Rescue Treatment for Nasal Allergen Challenge-induced Airway Inflammation,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,Study stopped due to COVID-19 pandemic.,f,,,,t,t,f,,,,,,9 to 36 months following publication,"Approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execution of a data use/sharing agreement with UNC.",,YES,"Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.",2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,OTHER,,,,,,,2023,0.0
NCT02957019,,2016-10-27,,,2023-10-06,2016-11-03,2016-11-06,ESTIMATED,,,,,,,2023-10-06,2023-10-10,ACTUAL,2013-07-31,ACTUAL,2013-07-31,2023-10,2023-10-31,2023-09-29,ACTUAL,2023-09-29,2023-09,ACTUAL,2023-09-30,,INTERVENTIONAL,,,A Phase I/II Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL),A Phase I/II Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL),TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,Philogen S.p.A.,,1.0,,Slow progression due to difficulties in finding eligible patients. Competitive clinical trials with innovative agents and new approved products leaddefinitive stop.,f,,,,t,,,,,,,,,,,,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,INDUSTRY,,,,,,,2023,0.0
NCT03308786,,2017-09-29,2021-11-29,,2022-09-01,2017-10-12,2017-10-13,ACTUAL,2022-09-01,2022-09-28,ACTUAL,,,,2022-09-01,2022-09-28,ACTUAL,2019-04-01,ACTUAL,2019-04-01,2022-09,2022-09-30,2020-08-20,ACTUAL,2020-08-20,2020-08-20,ACTUAL,2020-08-20,,INTERVENTIONAL,IL2,,HIV Reservoir Reduction With Interleukin-2,HIV Reservoir Reduction With Interleukin-2,TERMINATED,,PHASE2,9.0,ACTUAL,Case Western Reserve University,"On the basis of recommendation of the SMC, the study was terminated. Because of this, the primary objective could not be achieved and most of the secondary objectives could not be achieved.",1.0,,There were 3 instances of adverse events which were discussed with external safety monitoring committee and it was recommended that the study be terminated.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,OTHER,,,,,,,2020,0.0
NCT05934942,,2023-06-29,,,2024-02-19,2023-06-29,2023-07-07,ACTUAL,,,,,,,2024-02-19,2024-02-20,ACTUAL,2023-09-08,ACTUAL,2023-09-08,2024-02,2024-02-29,2024-02-08,ACTUAL,2024-02-08,2024-02-08,ACTUAL,2024-02-08,,INTERVENTIONAL,,,A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood,"An Open-label, Fixed-sequence Cross-over, Two-period, Phase I Trial to Evaluate the Effect of Multiple Doses of BI 1358894 on the Pharmacokinetics of a Combination of Ethinylestradiol and Drospirenone in Healthy Female Subjects",TERMINATED,,PHASE1,29.0,ACTUAL,Boehringer Ingelheim,,1.0,,Company decision,f,,,,f,f,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).~For more details refer to:~https://www.mystudywindow.com/msw/datatransparency",2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,INDUSTRY,,,,,,,2024,0.0
NCT02656914,,2016-01-12,,,2019-10-14,2016-01-13,2016-01-15,ESTIMATED,,,,,,,2019-10-14,2019-10-16,ACTUAL,2019-06,ESTIMATED,2019-06-30,2019-10,2019-10-31,2020-09,ESTIMATED,2020-09-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,Efficacy and Safety of Irlanda-2 Association on the Treatment of Common Cold,"Phase III, National, Multicenter, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy and Safety of Irlanda-2 Association on the Treatment of Common Cold",WITHDRAWN,,PHASE3,0.0,ACTUAL,EMS,,2.0,,Sponsor decision,f,,,,t,f,f,,,,,,,,,,,2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,INDUSTRY,,,,,,,2020,0.0
NCT03830281,,2019-02-04,2021-01-04,,2021-01-04,2019-02-04,2019-02-05,ACTUAL,2021-01-04,2021-01-22,ACTUAL,,,,2021-01-04,2021-01-22,ACTUAL,2019-02-14,ACTUAL,2019-02-14,2020-01,2020-01-31,2020-01-06,ACTUAL,2020-01-06,2020-01-06,ACTUAL,2020-01-06,,INTERVENTIONAL,PRONTO-Pump-2,All randomized participants.,A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy,"A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion",COMPLETED,,PHASE3,471.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,INDUSTRY,,,,,,,2020,1.0
NCT04195906,,2019-12-10,2023-11-15,,2024-01-25,2019-12-10,2019-12-12,ACTUAL,2024-01-25,2024-02-20,ACTUAL,,,,2024-01-25,2024-02-20,ACTUAL,2020-02-12,ACTUAL,2020-02-12,2023-12,2023-12-31,2022-10-24,ACTUAL,2022-10-24,2022-10-24,ACTUAL,2022-10-24,,INTERVENTIONAL,Calciphyx,"Modified Intent-to-treat Population (mITT): The modified mITT population was defined as all enrolled subjects who were randomized, received at least one dose of study drug, and had at least one post-randomization efficacy evaluation.~The mITT population was the primary analysis population for efficacy endpoints.",Phase 3 Study of SNF472 for Calciphylaxis,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SNF472 When Added to Background Care for the Treatment of Calciphylaxis",COMPLETED,,PHASE3,71.0,ACTUAL,Sanifit Therapeutics S. A.,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,OTHER,,,,,,,2022,1.0
NCT04267822,,2020-02-05,,,2023-05-04,2020-02-11,2020-02-13,ACTUAL,,,,,,,2023-05-04,2023-05-08,ACTUAL,2020-06-15,ESTIMATED,2020-06-15,2023-05,2023-05-31,2023-07-31,ESTIMATED,2023-07-31,2023-06-30,ESTIMATED,2023-06-30,,INTERVENTIONAL,REVIRAL2,,Study of RV521 in the Treatment of Adult Subjects Who Have Undergone HCT With an URTI With RSV,"Randomized, Double-blind, Placebo-controlled Trial of the Safety, Tolerability, and Efficacy of RV521 in the Treatment of Adult Subjects Who Have Undergone Hematopoietic Cell Transplantation (HCT) With a Documented Upper Respiratory Tract Infection (URTI) With Respiratory Syncytial Virus (RSV)",WITHDRAWN,,PHASE2,0.0,ACTUAL,Pfizer,,2.0,,No recruitment,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,INDUSTRY,,,,,,,2023,0.0
NCT04345107,,2020-04-09,,,2022-03-21,2020-04-10,2020-04-14,ACTUAL,,,,,,,2022-03-21,2022-04-01,ACTUAL,2020-05-01,ACTUAL,2020-05-01,2021-05,2021-05-31,2021-09-21,ACTUAL,2021-09-21,2021-04-29,ACTUAL,2021-04-29,,INTERVENTIONAL,,,Multiple Ascending Doses of SY-009 in Type 2 Diabetes Mellitus,"A Phase Ib Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SY-009 After Multiple Ascending Doses in Patients With Type 2 Diabetes Mellitus",COMPLETED,,PHASE1,50.0,ACTUAL,"Suzhou Yabao Pharmaceutical R&D Co., Ltd.",,7.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,INDUSTRY,,,,,,,2021,1.0
NCT00660673,,2008-04-15,2022-10-20,,2022-11-15,2008-04-15,2008-04-17,ESTIMATED,2022-11-15,2022-12-02,ACTUAL,,,,2022-11-15,2022-12-02,ACTUAL,2009-11-13,ACTUAL,2009-11-13,2022-11,2022-11-30,2021-11-30,ACTUAL,2021-11-30,2021-11-30,ACTUAL,2021-11-30,,INTERVENTIONAL,,,Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease,Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies,COMPLETED,,PHASE3,262.0,ACTUAL,AbbVie,,1.0,,,f,,,,f,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,INDUSTRY,,,,,,,2021,1.0
NCT03235986,,2017-07-26,,,2022-03-16,2017-07-31,2017-08-01,ACTUAL,,,,,,,2022-03-16,2022-03-31,ACTUAL,2017-08-28,ACTUAL,2017-08-28,2022-03,2022-03-31,2020-05-05,ACTUAL,2020-05-05,2020-05-05,ACTUAL,2020-05-05,,INTERVENTIONAL,,,"A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)","A Randomized, Open, Multinational, Multicentre,2-Part Study In Spontaneously Breathing Preterm Neonates With Mild To Moderate Respiratory Distress Syndrome (RDS) To Investigate The Safety, Tolerability And Efficacy Of Inhaled Nebulised Poractant Alfa (Porcine Surfactant, Curosurf®) In Comparison With Nasal Continuous Positive Airway Pressure (nCPAP) Alone",TERMINATED,,PHASE2,166.0,ACTUAL,Chiesi Farmaceutici S.p.A.,,2.0,,Change in the benefit-risk balance,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,INDUSTRY,,,,,,,2020,0.0
NCT03841448,,2019-02-13,2023-09-12,,2024-08-02,2019-02-13,2019-02-15,ACTUAL,2023-12-07,2023-12-08,ACTUAL,,,,2024-08-02,2024-08-09,ACTUAL,2019-09-30,ACTUAL,2019-09-30,2024-06,2024-06-30,2023-06-27,ACTUAL,2023-06-27,2022-03-17,ACTUAL,2022-03-17,,INTERVENTIONAL,,Safety Analysis Set included all participants who received any amount of study drug.,A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN),"A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients With IgA Nephropathy",TERMINATED,,PHASE2,31.0,ACTUAL,Alnylam Pharmaceuticals,,4.0,,Study was terminated early having identified clinically meaningful magnitude of proteinuria reduction due to cemdisiran (study goal). Participants completed DBT period\&were in OLE period. Sponsor had no concerns with safety\&integrity of participants.,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,INDUSTRY,,,,,,,2023,0.0
NCT05456165,,2022-07-08,,,2022-11-21,2022-07-08,2022-07-13,ACTUAL,,,,,,,2022-11-21,2022-11-25,ACTUAL,2022-05-19,ACTUAL,2022-05-19,2022-11,2022-11-30,2022-09-01,ACTUAL,2022-09-01,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,,,Study of an Individualized Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer,"A Randomized, Open-Label, Phase 2 Study of a Patient-Specific Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer With Minimal Residual Disease Following Surgical Resection and Standard Adjuvant Chemotherapy",TERMINATED,,PHASE2,1.0,ACTUAL,"Gritstone bio, Inc.",,2.0,,terminated due to reprioritization,f,,,,f,t,f,,,,,,,,,,,2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,INDUSTRY,,,,,,,2022,0.0
NCT04985136,,2021-07-15,,,2022-08-29,2021-07-26,2021-08-02,ACTUAL,,,,,,,2022-08-29,2022-09-01,ACTUAL,2021-09-26,ACTUAL,2021-09-26,2021-07,2021-07-31,2021-12-29,ACTUAL,2021-12-29,2021-12-29,ACTUAL,2021-12-29,,INTERVENTIONAL,,,A Study of Camrelizumab Combined With Rivoceranib Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC),"A Randomized, Open-Label, Controlled, International Multi-Center Phase III Clinical Study of Camrelizumab Combined With Rivoceranib (Apatinib) Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Hepatocellular Carcinoma (HCC) Who Have Been Treated With Immune Checkpoint Inhibitors (ICIs)",TERMINATED,,PHASE3,1.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,4.0,,Sponsor R \& D Strategy Adjustment,f,,,,,f,f,,,,,,,,,,,2024-10-15 18:03:23.937454,2024-10-15 18:03:23.937454,INDUSTRY,,,,,,,2021,0.0
NCT03439085,,2018-02-14,2023-07-27,,2024-06-13,2018-02-14,2018-02-20,ACTUAL,2024-06-13,2024-07-09,ACTUAL,,,,2024-06-13,2024-07-09,ACTUAL,2018-11-14,ACTUAL,2018-11-14,2024-05,2024-05-31,2022-09-20,ACTUAL,2022-09-20,2022-09-20,ACTUAL,2022-09-20,,INTERVENTIONAL,,,DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers,"A Phase 2, Open-Label Study to Evaluate Efficacy of Combination Treatment With MEDI0457 (INO-3112) and Durvalumab (MEDI4736) in Patients With Recurrent/Metastatic Human Papilloma Virus Associated Cancers",TERMINATED,,PHASE2,41.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Project delays,f,,,,f,t,f,,,,,,,,,,,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,OTHER,,,,,,,2022,0.0
NCT01160211,,2010-07-01,2019-01-03,,2022-06-10,2010-07-08,2010-07-12,ESTIMATED,2019-05-01,2019-07-15,ACTUAL,,,,2022-06-10,2022-06-30,ACTUAL,2011-05-05,ACTUAL,2011-05-05,2022-06,2022-06-30,2022-06-06,ACTUAL,2022-06-06,2016-03-11,ACTUAL,2016-03-11,,INTERVENTIONAL,,Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not treatment was administered. ITT was based on the treatment to which the subject was randomized and was the primary population for the analysis of efficacy data. Any subject who received a treatment randomization # was considered to have been randomized.,"A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer","A Phase III Trial to Compare the Safety and Efficacy of Lapatinib Plus Trastuzumab Plus an Aromatase Inhibitor (AI) vs. Trastuzumab Plus an AI vs. Lapatinib Plus an AI as 1st- or 2nd- Line Therapy in Postmenopausal Subjects With Hormone Receptor+, HER2-positive Metastatic Breast Cancer (MBC) Who Received Prior Trastuzumab and Endocrine Therapies",COMPLETED,,PHASE3,369.0,ACTUAL,Novartis,,3.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 08:26:05.224329,2024-10-15 08:26:05.224329,INDUSTRY,,,,,,,2022,1.0
NCT03267836,,2017-08-29,,,2023-06-13,2017-08-29,2017-08-30,ACTUAL,,,,,,,2023-06-13,2023-06-15,ACTUAL,2018-01-10,ACTUAL,2018-01-10,2023-06,2023-06-30,2023-04-06,ACTUAL,2023-04-06,2023-04-06,ACTUAL,2023-04-06,,INTERVENTIONAL,,,Neoadjuvant Avelumab and Hypofractionated Proton Radiation Therapy Followed by Surgery for Recurrent Radiation-refractory Meningioma,A Phase Ib Study of Neoadjuvant Avelumab and Hypofractionated Proton Radiation Therapy Followed by Surgery for Recurrent Radiation-refractory Meningioma,TERMINATED,,PHASE1,9.0,ACTUAL,Washington University School of Medicine,,1.0,,Study sponsor wanted to terminate enrollment.,f,,,,t,t,t,,,t,,,,,,NO,,2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,OTHER,,,,,,,2023,0.0
NCT02451111,,2015-05-19,,,2024-03-11,2015-05-20,2015-05-21,ESTIMATED,,,,,,,2024-03-11,2024-03-13,ACTUAL,2015-11-06,ACTUAL,2015-11-06,2024-03,2024-03-31,2023-07-15,ACTUAL,2023-07-15,2022-12-01,ACTUAL,2022-12-01,,INTERVENTIONAL,,,Rituximab With or Without Ibrutinib for Patients With Advanced Follicular Lymphoma,"Rituximab With or Without Ibrutinib for Untreated Patients With Advanced Follicular Lymphoma in Need of Therapy. A Randomized, Double-blinded, SAKK and NLG Collaborative Phase II Trial.",TERMINATED,,PHASE2,190.0,ACTUAL,Swiss Group for Clinical Cancer Research,,2.0,,"The premature termination is based on the decision by the SAKK board on November 14, 2020 due to the lack of further financial support for the follow up period.",f,,,,t,,,,,,,,,,,NO,,2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,OTHER,,,,,,,2023,0.0
NCT04015492,,2019-07-09,,,2020-12-17,2019-07-09,2019-07-11,ACTUAL,,,,,,,2020-12-17,2020-12-21,ACTUAL,2019-08-08,ACTUAL,2019-08-08,2020-12,2020-12-31,2020-01-29,ACTUAL,2020-01-29,2019-10-25,ACTUAL,2019-10-25,,INTERVENTIONAL,,,Study to Compare How the Body Distributes and Excretes the Drugs Jivi (BAY 94-9027) and Adynovi in Patients With Severe Hemophilia A (Bleeding Disorder Resulting From a Lack of Blood Clotting Factor VIII),"Single Dose, Open Label, Randomized, Cross-over Study in Participants With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94-9027 and Adynovi",COMPLETED,,PHASE1,18.0,ACTUAL,Bayer,,2.0,,,f,,,,f,t,f,,,t,,,,,,UNDECIDED,"Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,INDUSTRY,,,,,,,2020,1.0
NCT01557244,,2012-03-15,2020-10-23,,2021-01-12,2012-03-15,2012-03-19,ESTIMATED,2021-01-12,2021-02-02,ACTUAL,,,,2021-01-12,2021-02-02,ACTUAL,2012-07-02,ACTUAL,2012-07-02,2020-12,2020-12-31,2020-02-13,ACTUAL,2020-02-13,2019-11-07,ACTUAL,2019-11-07,,INTERVENTIONAL,,Analysis population included all randomized participants.,A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition,"A 24-WEEK RANDOMIZED, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FESOTERODINE IN SUBJECTS AGED 6 TO 17 YEARS WITH SYMPTOMS OF DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGICAL CONDITION (NEUROGENIC DETRUSOR OVERACTIVITY)",COMPLETED,,PHASE3,181.0,ACTUAL,Pfizer,,5.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,INDUSTRY,,,,,,,2020,1.0
NCT02876094,,2016-08-09,,,2020-10-13,2016-08-18,2016-08-23,ESTIMATED,,,,,,,2020-10-13,2020-10-19,ACTUAL,2019-01-29,ACTUAL,2019-01-29,2020-10,2020-10-31,2020-08-06,ACTUAL,2020-08-06,2020-08-06,ACTUAL,2020-08-06,,INTERVENTIONAL,SMA,,Effect of Low-Dose Celecoxib on SMN2 in Patients With Spinal Muscular Atrophy,"A Pilot, Open-Label, Dose Response Study Investigating the Effect of Low-Dose Celecoxib on SMN2 in Patients With Spinal Muscular Atrophy (SMA)",TERMINATED,,PHASE2,1.0,ACTUAL,Children's Hospital of Eastern Ontario,,1.0,,Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention,f,,,,t,f,f,,,,,,,,,YES,Results will be submitted for presentation at an international meeting and subsequently submitted for publication in a major international peer-reviewed medical journal.,2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,OTHER,,,,,,,2020,0.0
NCT03959553,,2019-05-08,,,2022-02-15,2019-05-21,2019-05-22,ACTUAL,,,,,,,2022-02-15,2022-03-03,ACTUAL,2019-09-01,ESTIMATED,2019-09-01,2019-05,2019-05-31,2022-02-28,ESTIMATED,2022-02-28,2021-08-31,ESTIMATED,2021-08-31,,INTERVENTIONAL,,,GV1001 Subcutaneous(SC) for the Treatment of Moderate Alzheimer's Disease (AD),"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Prospective, Phase IIa Clinical Trial to Evaluate the Safety and Efficacy of GV1001 Administered Subcutaneously for the Treatment of Moderate Alzheimer's Disease",WITHDRAWN,,PHASE2,0.0,ACTUAL,GemVax & Kael,,3.0,,The study was stopped due to protocol amendment and project name change.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,INDUSTRY,,,,,,,2022,0.0
NCT04425629,,2020-06-08,2023-01-20,,2023-12-20,2020-06-08,2020-06-11,ACTUAL,2023-12-20,2023-12-21,ACTUAL,,,,2023-12-20,2023-12-21,ACTUAL,2020-06-16,ACTUAL,2020-06-16,2023-12,2023-12-31,2022-06-09,ACTUAL,2022-06-09,2022-01-21,ACTUAL,2022-01-21,,INTERVENTIONAL,,,"Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19","A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients With COVID-19",TERMINATED,,PHASE3,10078.0,ACTUAL,Regeneron Pharmaceuticals,"Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis, as such endpoints related to nasal or saliva samples were not analyzed. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections",1.0,,Emerging SARS-CoV-2 variants impacting susceptibility to study drug,t,,,,t,t,f,,,,,,"Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification","Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).",https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-15 18:03:23.937454,2024-10-15 18:03:23.937454,INDUSTRY,,NCT04617535,NO_LONGER_AVAILABLE,,,,2022,0.0
NCT04056611,,2019-08-13,2023-02-01,,2023-03-22,2019-08-13,2019-08-14,ACTUAL,2023-03-22,2023-04-14,ACTUAL,,,,2023-03-22,2023-04-14,ACTUAL,2019-12-26,ACTUAL,2019-12-26,2023-03,2023-03-31,2022-02-04,ACTUAL,2022-02-04,2022-02-04,ACTUAL,2022-02-04,,INTERVENTIONAL,FREESIA,,Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV),"A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract",TERMINATED,,PHASE2,3.0,ACTUAL,Janssen Sciences Ireland UC,"As the study was terminated early due to low number of participants enrolled, some efficacy analyses were not performed as per change in the planned analysis. Hence, data were collected and analyzed for safety and selected efficacy parameters only.",2.0,,A strategic decision was made to discontinue the study. The decision was not based on a safety concern.,t,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,INDUSTRY,,NCT04221412,NO_LONGER_AVAILABLE,,,,2022,0.0
NCT03988023,,2019-06-13,2022-08-31,,2022-09-27,2019-06-13,2019-06-17,ACTUAL,2022-09-27,2022-10-05,ACTUAL,,,,2022-09-27,2022-10-05,ACTUAL,2019-06-24,ACTUAL,2019-06-24,2022-08,2022-08-31,2021-07-13,ACTUAL,2021-07-13,2021-07-13,ACTUAL,2021-07-13,,INTERVENTIONAL,,,Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee.,"A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults With Pain Due to Severe Osteoarthritis of the Knee.",TERMINATED,,PHASE3,1043.0,ACTUAL,Ampio Pharmaceuticals. Inc.,The AP-013 study was prematurely terminated by the sponsor after Data Safety Monitoring Board (DSMB) guidance.,2.0,,The AP-013 study was prematurely terminated by the sponsor after Data Safety Monitoring Board (DSMB) guidance.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,INDUSTRY,,,,,,,2021,0.0
NCT03629210,,2018-08-09,,,2019-11-11,2018-08-09,2018-08-14,ACTUAL,,,,,,,2019-11-11,2019-11-13,ACTUAL,2019-09,ESTIMATED,2019-09-30,2019-11,2019-11-30,2021-05,ESTIMATED,2021-05-31,2021-02,ESTIMATED,2021-02-28,,INTERVENTIONAL,COLLIDE,,Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema,Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema (COLLIDE),WITHDRAWN,,PHASE2,0.0,ACTUAL,North Toronto Eye Care Laser and Eye Specialists,,2.0,,Study funding discontinued,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,OTHER,,,,,,,2021,0.0
NCT04882072,,2021-05-10,,,2023-07-27,2021-05-10,2021-05-11,ACTUAL,,,,,,,2023-07-27,2023-08-01,ACTUAL,2021-09-15,ACTUAL,2021-09-15,2023-07,2023-07-31,2023-05-25,ACTUAL,2023-05-25,2023-05-25,ACTUAL,2023-05-25,,INTERVENTIONAL,,,A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK),"A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Participants With Takayasu Arteritis",TERMINATED,,PHASE3,14.0,ACTUAL,Janssen Pharmaceutical K.K.,,2.0,,Due to difficulties in enrollment and ongoing feasibility issues,f,,,,t,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,INDUSTRY,,,,,,,2023,0.0
NCT03090880,,2017-03-21,,,2022-11-14,2017-03-21,2017-03-27,ACTUAL,,,,,,,2022-11-14,2022-11-17,ACTUAL,2018-09-14,ACTUAL,2018-09-14,2021-12,2021-12-31,2021-08-18,ACTUAL,2021-08-18,2021-08-18,ACTUAL,2021-08-18,,INTERVENTIONAL,PROVE,,Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE),Long-term Prophylaxis of Venous Thromboembolism With Low-molecular-weight Heparin in Patients With Metastatic Lung Cancer,TERMINATED,,PHASE3,59.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,"The rate of inclusion is too low to hope to reach the target of 800 patients. 59 patients were included, and their data will not meet the research objectives.~The sponsor has decided to prematurely stop inclusions on January 13, 2022.",f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,OTHER,,,,,,,2021,0.0
NCT04185311,,2019-07-03,,,2023-08-11,2019-12-02,2019-12-04,ACTUAL,,,,,,,2023-08-11,2023-08-15,ACTUAL,2019-07-10,ACTUAL,2019-07-10,2023-08,2023-08-31,2023-05-17,ACTUAL,2023-05-17,2023-05-17,ACTUAL,2023-05-17,,INTERVENTIONAL,,,"Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted","A Phase 1 Study of Ipilumumab, Nivolumab and Talimogene Laherparepvec Preoperative Treatment of Localized Breast Cancer-deleted",TERMINATED,,PHASE1,6.0,ACTUAL,Jonsson Comprehensive Cancer Center,,1.0,,enrollment,,,,,t,t,f,,,t,,,,,,,,2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,OTHER,,,,,,,2023,0.0
NCT03001882,,2016-12-21,2023-02-02,,2024-04-22,2016-12-22,2016-12-23,ESTIMATED,2023-05-09,2023-06-06,ACTUAL,,,,2024-04-22,2024-05-20,ACTUAL,2017-03-29,ACTUAL,2017-03-29,2024-04,2024-04-30,2023-04-24,ACTUAL,2023-04-24,2022-02-17,ACTUAL,2022-02-17,,INTERVENTIONAL,CheckMate 592,,An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC),An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in Combination With Ipilimumab in Subjects With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC),COMPLETED,,PHASE2,230.0,ACTUAL,Bristol-Myers Squibb,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,INDUSTRY,,,,,,,2023,0.0
NCT04901676,,2021-05-24,,,2022-04-08,2021-05-24,2021-05-25,ACTUAL,,,,,,,2022-04-08,2022-04-15,ACTUAL,2021-09-09,ACTUAL,2021-09-09,2021-05,2021-05-31,2023-02,ESTIMATED,2023-02-28,2023-01,ESTIMATED,2023-01-31,,INTERVENTIONAL,,,Leronlimab in Moderately Ill Patients With COVID-19 Pneumonia,"A Phase 3, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Leronlimab in Combination With Standard of Care for Moderately Ill Patients With Coronavirus Disease 2019 (COVID-19) Pneumonia",SUSPENDED,,PHASE3,612.0,ESTIMATED,Hospital Israelita Albert Einstein,,2.0,,Pending DSMB evaluation,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,OTHER,,,,,,,2023,0.0
NCT05092646,,2021-10-08,,,2024-02-06,2021-10-21,2021-10-25,ACTUAL,,,,,,,2024-02-06,2024-02-08,ACTUAL,2021-12-01,ACTUAL,2021-12-01,2024-02,2024-02-29,2023-11-10,ACTUAL,2023-11-10,2023-11-10,ACTUAL,2023-11-10,,INTERVENTIONAL,Phoenix,,Evaluating Intra-articular Injection of Axolotl Ambient Compared to Saline in Subjects With Ankle Osteoarthritis,"A Double-blind, Multi-Center, Prospective, Randomized Placebo-controlled Pilot Study Evaluating Intra-articular Injection of Axolotl Ambient Compared to Saline in Subjects With Ankle Osteoarthritis",TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,Axolotl Biologix,,2.0,,Study stopped due to lack of enrollment,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,INDUSTRY,,,,,,,2023,0.0
NCT03861364,,2019-03-01,,,2020-06-16,2019-03-01,2019-03-04,ACTUAL,,,,,,,2020-06-16,2020-06-17,ACTUAL,2019-09-03,ACTUAL,2019-09-03,2020-06,2020-06-30,2020-05-31,ACTUAL,2020-05-31,2020-05-19,ACTUAL,2020-05-19,,INTERVENTIONAL,PH,,Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose.,"Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Low vs High Propofol Doses.",COMPLETED,,PHASE4,68.0,ACTUAL,Helse Fonna,,2.0,,,f,,,,f,f,f,,,f,,,"The data will be stored for 15 years after end of study, and may be shared during this time frame.",The data may be shared by contacting the Principal Investigator.,,YES,"LiDCO-csv raw data and processed data will be made public at the publishers site, and the supporting information by request to the Principal Investigator. Statistical Data Plan is included in Study Protocol.",2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,OTHER,,,,,,,2020,1.0
NCT03510715,,2018-04-18,2020-12-02,,2020-12-02,2018-04-18,2018-04-27,ACTUAL,2020-12-02,2020-12-29,ACTUAL,,,,2020-12-02,2020-12-29,ACTUAL,2018-08-31,ACTUAL,2018-08-31,2020-10,2020-10-31,2020-02-17,ACTUAL,2020-02-17,2020-02-17,ACTUAL,2020-02-17,,INTERVENTIONAL,,Analysis was performed on all enrolled participants.,An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia,An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia,COMPLETED,,PHASE3,18.0,ACTUAL,Sanofi,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,INDUSTRY,,,,,,,2020,1.0
NCT04354103,,2020-04-07,,,2024-01-19,2020-04-20,2020-04-21,ACTUAL,,,,,,,2024-01-19,2024-01-23,ACTUAL,2022-05-31,ACTUAL,2022-05-31,2023-11,2023-11-30,2024-01-19,ACTUAL,2024-01-19,2024-01-19,ACTUAL,2024-01-19,,INTERVENTIONAL,ATO-TS,,Atomoxetine in Patients With Tourette's Syndrome,A Pilot Study to Evaluate the Effects of Atomoxetine on Impulsivity in Patients With Tourette's Syndrome,TERMINATED,,PHASE2,5.0,ACTUAL,Poitiers University Hospital,,1.0,,experimental treatment (Atomoxetine) not available,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,OTHER,,,,,,,2024,0.0
NCT05127486,,2021-11-03,2024-05-22,,2024-06-17,2021-11-10,2021-11-19,ACTUAL,2024-05-22,2024-06-18,ACTUAL,,,,2024-06-17,2024-06-28,ACTUAL,2021-12-06,ACTUAL,2021-12-06,2024-06,2024-06-30,2023-05-23,ACTUAL,2023-05-23,2023-05-23,ACTUAL,2023-05-23,,INTERVENTIONAL,CHALLENGE-MIG,All randomized participants.,A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine,"A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Galcanezumab Versus Rimegepant in Adult Participants With Episodic Migraine",COMPLETED,,PHASE4,580.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,INDUSTRY,,,,,,,2023,1.0
NCT04525352,,2020-08-11,,,2022-07-11,2020-08-20,2020-08-25,ACTUAL,,,,,,,2022-07-11,2022-07-13,ACTUAL,2020-11-19,ACTUAL,2020-11-19,2022-07,2022-07-31,2021-05-21,ACTUAL,2021-05-21,2021-05-21,ACTUAL,2021-05-21,,INTERVENTIONAL,,,A Trial to Evaluate Safety and Efficacy of RP-L401-0120 in Subjects With Infantile Malignant Osteopetrosis,A Phase I Clinical Trial for Gene Therapy in Infantile Malignant Osteopetrosis (IMO) to Evaluate the Safety and Preliminary Efficacy of Autologous CD34+ Enriched Cells Transduced With a LV Vector Encoding the TCIRG1 Gene,TERMINATED,,PHASE1,1.0,ACTUAL,Rocket Pharmaceuticals Inc.,,1.0,,Study discontinued due to feasibility.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,INDUSTRY,,,,,,,2021,0.0
NCT02549170,,2015-09-11,2023-02-22,,2023-05-23,2015-09-11,2015-09-15,ESTIMATED,2023-05-23,2023-05-24,ACTUAL,,,,2023-05-23,2023-05-24,ACTUAL,2015-12-15,ACTUAL,2015-12-15,2023-05,2023-05-31,2022-02-23,ACTUAL,2022-02-23,2022-02-23,ACTUAL,2022-02-23,,INTERVENTIONAL,,Epoch 1 safety analysis set included all participants who received any study treatment.,A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP),"A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)",COMPLETED,,PHASE3,138.0,ACTUAL,Takeda,,5.0,,,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,INDUSTRY,,,,,,,2022,1.0
NCT03116113,,2017-03-29,2023-11-16,2021-11-17,2023-12-22,2017-04-13,2017-04-14,ACTUAL,2023-12-22,2024-01-18,ACTUAL,2021-11-17,2021-11-22,ACTUAL,2023-12-22,2024-01-18,ACTUAL,2017-03-08,ACTUAL,2017-03-08,2023-12,2023-12-31,2020-11-18,ACTUAL,2020-11-18,2020-11-18,ACTUAL,2020-11-18,,INTERVENTIONAL,XIRIUS,Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112).,A Clinical Trial of Retinal Gene Therapy for X-linked Retinitis Pigmentosa Using BIIB112,"A Dose Escalation (Phase 1), and Dose Expansion (Phase 2/3) Clinical Trial of Retinal Gene Therapy for X-linked Retinitis Pigmentosa Using an Adeno-Associated Viral Vector (AAV8) Encoding Retinitis Pigmentosa GTPase Regulator (RPGR)",COMPLETED,,PHASE1/PHASE2,50.0,ACTUAL,Biogen,,9.0,,,f,,,,t,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,INDUSTRY,,,,,,,2020,1.0
NCT06197217,,2024-01-08,,,2024-06-11,2024-01-08,2024-01-09,ACTUAL,,,,,,,2024-06-11,2024-06-12,ACTUAL,2023-06-14,ACTUAL,2023-06-14,2024-06,2024-06-30,2023-09-20,ACTUAL,2023-09-20,2023-08-21,ACTUAL,2023-08-21,,INTERVENTIONAL,,,Phase III Clinical Study Evaluating the Efficacy and Safety of WPV01 in Patients With Mild/Moderate COVID-19,"A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of WPV01 in Patients With Mild to Moderate COVID-19",COMPLETED,,PHASE3,1350.0,ACTUAL,"Westlake Pharmaceuticals (Hangzhou) Co., Ltd.",,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,INDUSTRY,,,,,,,2023,1.0
NCT04237649,,2020-01-17,,,2024-07-11,2020-01-17,2020-01-23,ACTUAL,,,,,,,2024-07-11,2024-07-12,ACTUAL,2020-02-20,ACTUAL,2020-02-20,2024-07,2024-07-31,2023-09-15,ACTUAL,2023-09-15,2023-09-15,ACTUAL,2023-09-15,,INTERVENTIONAL,,,"KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors","A Phase I/Ib, Open-label, Multi-center, Study of KAZ954 as a Single Agent and in Combination With Spartalizumab, NZV930 and NIR178 in Patients With Advanced Solid Tumors",TERMINATED,,EARLY_PHASE1,77.0,ACTUAL,Novartis,,4.0,,Business reasons,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,INDUSTRY,,,,,,,2023,0.0
NCT05076422,,2021-10-05,,,2023-03-13,2021-10-05,2021-10-13,ACTUAL,,,,,,,2023-03-13,2023-03-14,ACTUAL,2021-10-18,ACTUAL,2021-10-18,2023-03,2023-03-31,2023-03-03,ACTUAL,2023-03-03,2023-03-03,ACTUAL,2023-03-03,,INTERVENTIONAL,,,A Study to Test How Well Men Tolerate Different Doses of BI 3006337,"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 3006337 in Healthy Male Subjects (Single-blind, Partially Randomised Within Dose Groups, Placebo-controlled, Parallel (Sequential) Group Design)",COMPLETED,,PHASE1,80.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datatransparency",2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,INDUSTRY,,,,,,,2023,0.0
NCT03816488,,2019-01-18,,,2023-01-12,2019-01-23,2019-01-25,ACTUAL,,,,,,,2023-01-12,2023-01-13,ACTUAL,2023-12-01,ESTIMATED,2023-12-01,2023-01,2023-01-31,2024-12-01,ESTIMATED,2024-12-01,2024-06-01,ESTIMATED,2024-06-01,,INTERVENTIONAL,OPTIM(i)SING,,Oral Peri-operative TIming of Metformin (or) Salsalate to Improve Non-cardiac Surgery Glucose Control,Oral Peri-operative TIming of Metformin (or) Salsalate to Improve Non-cardiac Surgery Glucose Control - A Placebo-Controlled Internal Feasibility Trial,WITHDRAWN,,PHASE1,0.0,ACTUAL,McMaster University,,3.0,,Unable to source salsalate.,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,OTHER,,,,,,,2024,0.0
NCT05094050,,2021-10-20,,,2023-03-22,2021-10-20,2021-10-26,ACTUAL,,,,,,,2023-03-22,2023-03-24,ACTUAL,2022-01-18,ACTUAL,2022-01-18,2023-03,2023-03-31,2023-03-17,ACTUAL,2023-03-17,2023-03-17,ACTUAL,2023-03-17,,INTERVENTIONAL,,,Study to Assess How ABBV-951 is Absorbed When Administered at Different Subcutaneous Sites of Adult Participants With Parkinson's Disease,Parkinson's Disease: A Comparative Study of Levodopa and Carbidopa Bioavailability Following Foslevodopa/Foscarbidopa Infusion at Different Subcutaneous Sites in Parkinson's Disease Patients,COMPLETED,,PHASE1,16.0,ACTUAL,AbbVie,,4.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,INDUSTRY,,,,,,,2023,1.0
NCT04910165,,2021-05-25,2022-03-16,,2022-05-18,2021-05-28,2021-06-02,ACTUAL,2022-05-18,2022-05-20,ACTUAL,,,,2022-05-18,2022-05-20,ACTUAL,2020-06-01,ACTUAL,2020-06-01,2022-05,2022-05-31,2021-10-15,ACTUAL,2021-10-15,2021-09-15,ACTUAL,2021-09-15,,INTERVENTIONAL,,,Exparel Use in Adductor Canal Block After Total Knee Arthroplasty,Adductor Canal Blocks Using Exparel for Pain Control After Total Knee Arthroplasty,COMPLETED,,PHASE3,100.0,ACTUAL,"St. Luke's Hospital, Pennsylvania","Block efficacy is dependent on the performing anesthesiologist, with multiple performing anesthesiologists introducing variability that was not accounted for. The use of drains was surgeon specific rather than part of our study protocol. The state's online drug monitoring program reports narcotic prescriptions filled but not necessarily taken possibly pointing to a discrepancy. Finally, all patients were obtained from one demographic area, and all surgeries were only performed by two surgeons",2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2021,1.0
NCT03683667,,2018-09-21,,,2022-12-02,2018-09-21,2018-09-25,ACTUAL,,,,,,,2022-12-02,2022-12-05,ACTUAL,2018-09-23,ACTUAL,2018-09-23,2022-12,2022-12-31,2020-03-24,ACTUAL,2020-03-24,2020-03-19,ACTUAL,2020-03-19,,INTERVENTIONAL,JiVitA-6,,Protein Plus: Improving Infant Growth Through Diet and Enteric Health,"Efficacy of Supplemental Protein, Delivered Alone or in Combination With Treatment for Enteric Pathogens, to Prevent Growth Faltering in Bangladeshi Infants",COMPLETED,,PHASE2/PHASE3,5283.0,ACTUAL,Johns Hopkins Bloomberg School of Public Health,,8.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,OTHER,,,,,,,2020,1.0
NCT03853694,,2018-09-19,2022-04-04,,2022-07-15,2019-02-25,2019-02-26,ACTUAL,2022-07-15,2022-07-18,ACTUAL,,,,2022-07-15,2022-07-18,ACTUAL,2019-03-04,ACTUAL,2019-03-04,2022-07,2022-07-31,2020-01-16,ACTUAL,2020-01-16,2020-01-09,ACTUAL,2020-01-09,,INTERVENTIONAL,CHOICE,,Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section,"A Multicenter, Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of EXPAREL When Administered Via Infiltration Into the Transversus Abdominis Plane Versus Standard of Care in Subjects Undergoing Elective Cesarean Section (CHOICE)",COMPLETED,,PHASE4,167.0,ACTUAL,"Pacira Pharmaceuticals, Inc",,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,INDUSTRY,,,,,,,2020,1.0
NCT04512261,,2020-07-28,,,2022-06-28,2020-08-12,2020-08-13,ACTUAL,,,,,,,2022-06-28,2022-07-01,ACTUAL,2022-06-01,ESTIMATED,2022-06-01,2022-06,2022-06-30,2024-06-01,ESTIMATED,2024-06-01,2024-06-01,ESTIMATED,2024-06-01,,INTERVENTIONAL,TOPAZ,,TOPAZ: Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases,"TOPAZ: Single Arm, Open Label Phase 1b/2 Study of Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Cedars-Sinai Medical Center,,1.0,,Study withdrawn due to change in treatment landscape for HER2+ metastatic breast cancer.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 06:15:19.053453,2024-10-16 06:15:19.053453,OTHER,,,,,,,2024,0.0
NCT03460704,,2018-02-14,2023-12-11,,2023-12-11,2018-03-07,2018-03-09,ACTUAL,2023-12-11,2023-12-29,ACTUAL,,,,2023-12-11,2023-12-29,ACTUAL,2018-01-29,ACTUAL,2018-01-29,2023-12,2023-12-31,2022-03-15,ACTUAL,2022-03-15,2022-03-15,ACTUAL,2022-03-15,,INTERVENTIONAL,PROMIS-II,"The modified Intention-To-Treat (mITT) Population is the Full Analysis Set and comprised all subjects who provided informed consent, were randomised and received at least 1 dose or partial dose of the IMP.",Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium.,Efficacy and Safety of 12 Months of Therapy With Inhaled Colistimethate Sodium in Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With P. Aeruginosa,TERMINATED,,PHASE3,287.0,ACTUAL,Zambon SpA,,2.0,,The study was brought to an early close in March 2022 due to major ongoing recruitment issues primarily related to the COVID-19 pandemic and concerns regarding the continued randomization and exposure of subjects to placebo in the study.,f,,,,f,t,f,,,,,,,,,,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,INDUSTRY,,,,,,,2022,0.0
NCT02571530,,2015-09-16,,,2021-10-27,2015-10-07,2015-10-08,ESTIMATED,,,,,,,2021-10-27,2021-11-03,ACTUAL,2015-08,ACTUAL,2015-08-31,2021-10,2021-10-31,2021-06,ACTUAL,2021-06-30,2021-06,ACTUAL,2021-06-30,,INTERVENTIONAL,,,Super-selective Intra-arterial Cerebral Infusion of Trastuzumab for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer,Phase 1 Trial of Super-selective Intra-arterial Cerebral Infusion of Trastuzumab After Blood-Brain Barrier Disruption for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer,TERMINATED,,PHASE1,2.0,ACTUAL,Northwell Health,,1.0,,Low enrollment,f,,,,f,,,,,,,,,,,,,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,OTHER,,,,,,,2021,0.0
NCT04849273,,2021-04-12,,,2023-05-24,2021-04-16,2021-04-19,ACTUAL,,,,,,,2023-05-24,2023-05-26,ACTUAL,2021-07-28,ACTUAL,2021-07-28,2023-05,2023-05-31,2023-04-18,ACTUAL,2023-04-18,2023-04-18,ACTUAL,2023-04-18,,INTERVENTIONAL,,,"A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC","A Phase 1/2 Study of TPX-0131, A Novel Oral ALK Tyrosine Kinase Inhibitor in Subjects With ALK+ Advanced or Metastatic NSCLC",TERMINATED,,PHASE1,11.0,ACTUAL,"Turning Point Therapeutics, Inc.",,1.0,,Adverse change in the risk/benefit.,f,,,,t,t,f,,,,,,,,,,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,INDUSTRY,,,,,,,2023,0.0
NCT01120028,,2010-05-06,2019-06-10,,2020-03-23,2010-05-06,2010-05-10,ESTIMATED,2019-09-26,2019-10-01,ACTUAL,,,,2020-03-23,2020-04-02,ACTUAL,2010-09,ACTUAL,2010-09-30,2020-03,2020-03-31,2020-03,ACTUAL,2020-03-31,2014-02,ACTUAL,2014-02-28,,INTERVENTIONAL,3C,"Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab).~Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).","Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy","Open-label, Randomised Multicentre Study of CAMPATH-1H Versus Basiliximab Induction Treatment and Sirolimus Versus Tacrolimus Maintenance Treatment for the Preservation of Renal Function in Patients Receiving Kidney Transplants",COMPLETED,,PHASE2/PHASE3,852.0,ACTUAL,University of Oxford,,4.0,,,f,,,,t,,,,,,,,,See URL,https://www.ndph.ox.ac.uk/data-access,YES,Proposals for substudies must be approved by the Steering Committee. Procedure for accessing the data for this study are available on https://www.ndph.ox.ac.uk/data-access,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,OTHER,,,,,,,2020,1.0
NCT03181035,,2017-04-17,,,2024-08-09,2017-06-06,2017-06-08,ACTUAL,,,,,,,2024-08-09,2024-08-12,ACTUAL,2018-01-25,ACTUAL,2018-01-25,2024-07,2024-07-31,2024-12,ESTIMATED,2024-12-31,2024-09,ESTIMATED,2024-09-30,,INTERVENTIONAL,FAITH,,Correlation of FAZA PET Hypoxia Imaging To 3D Histology in Oral Tongue Cancer,Defining a Personalized Hypoxic Radiation Target Through Correlation of Functional F18-FAZA PET Imaging to Pimonidazole-stained 3D Whole-mounted Histological Specimen,SUSPENDED,,PHASE1/PHASE2,10.0,ESTIMATED,Sunnybrook Health Sciences Centre,,1.0,,Pause to enrolment due to COVID-19 pandemic and protocol amendment (change to equipment used),f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,OTHER,,,,,,,2024,0.0
NCT02580058,,2015-10-16,2019-09-09,,2023-06-20,2015-10-16,2015-10-20,ESTIMATED,2019-11-01,2019-11-19,ACTUAL,,,,2023-06-20,2023-07-10,ACTUAL,2015-12-21,ACTUAL,2015-12-21,2023-06,2023-06-30,2022-07-12,ACTUAL,2022-07-12,2018-09-19,ACTUAL,2018-09-19,,INTERVENTIONAL,,,A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200),"A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL DOXORUBICIN ALONE IN PATIENTS WITH PLATINUM-RESISTANT/REFRACTORY OVARIAN CANCER",COMPLETED,,PHASE3,566.0,ACTUAL,Pfizer,,3.0,,,f,,,,,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,INDUSTRY,,,,,,,2022,1.0
NCT02739035,,2016-03-31,2023-09-28,,2023-11-02,2016-04-13,2016-04-14,ESTIMATED,2023-11-02,2023-11-21,ACTUAL,,,,2023-11-02,2023-11-21,ACTUAL,2016-04,ACTUAL,2016-04-30,2023-11,2023-11-30,2022-12,ACTUAL,2022-12-31,2022-12,ACTUAL,2022-12-31,,INTERVENTIONAL,MUA,,MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty,Manipulation Under Anesthesia (MUA) to Treat Postoperative Stiffness After Total Knee Arthroplasty: A Multicenter Randomized Clinical Trial,COMPLETED,,PHASE4,130.0,ACTUAL,Mayo Clinic,"Participant dropout rates were higher than anticipated for in the initial enrollment calculations, and patient reported outcome surveys had low completion rates. As a result, the target of 90 power for results was not achieved for all study outcome metrics. Additional study is warranted regarding NSAID administration strategy for MUA patients in order to determine if NSAIDs can be useful in combatting the inflammatory cascade which is associated with arthrofibrosis and post TKA stiffness.",2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,OTHER,,,,,,,2022,1.0
NCT02607930,,2015-11-10,2018-05-02,,2022-02-07,2015-11-16,2015-11-18,ESTIMATED,2018-06-25,2018-07-23,ACTUAL,,,,2022-02-07,2022-03-02,ACTUAL,2015-11-13,ACTUAL,2015-11-13,2022-02,2022-02-28,2021-07-02,ACTUAL,2021-07-02,2017-05-09,ACTUAL,2017-05-09,,INTERVENTIONAL,,Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.,"Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults","A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naive Adults",COMPLETED,,PHASE3,631.0,ACTUAL,Gilead Sciences,,4.0,,,f,,,,t,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gileadclinicaltrials.com/transparency-policy/,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/",2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,INDUSTRY,,,,,,,2021,1.0
NCT03884959,,2019-03-03,,,2020-11-04,2019-03-19,2019-03-21,ACTUAL,,,,,,,2020-11-04,2020-11-06,ACTUAL,2018-07-12,ACTUAL,2018-07-12,2020-02,2020-02-29,2020-11-04,ACTUAL,2020-11-04,2020-11-04,ACTUAL,2020-11-04,,INTERVENTIONAL,,,A Safety and Efficacy Study of Infusions of HepaStem in Urea Cycle Disorders Pediatric Patients,"A Prospective, Open Label, Safety and Efficacy Study of Infusions of HepaStem in Urea Cycle Disorders Pediatric Patients",WITHDRAWN,,PHASE2,0.0,ACTUAL,"HLB Cell Co., Ltd.",,1.0,,Sponsor decided to stop enrollment,f,,,,f,f,f,,,,,,,,,,,2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,INDUSTRY,,,,,,,2020,0.0
NCT05461794,,2022-07-14,,,2024-03-01,2022-07-14,2022-07-18,ACTUAL,,,,,,,2024-03-01,2024-03-04,ACTUAL,2022-10-03,ACTUAL,2022-10-03,2023-11,2023-11-30,2024-02-26,ACTUAL,2024-02-26,2024-02-26,ACTUAL,2024-02-26,,INTERVENTIONAL,,,Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma,"A Phase 2, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Patients With Locally Advanced Unresectable or Metastatic Esophageal Squamous Cell Carcinoma That Progressed on or After Anti-PD-(L)1 Antibody Therapy",TERMINATED,,PHASE2,96.0,ACTUAL,BeiGene,,3.0,,Due to modification of company strategy.,f,,,,f,f,f,,,,,,,,,YES,,2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,INDUSTRY,,,,,,,2024,0.0
NCT04655586,,2020-12-02,2022-07-14,,2023-01-30,2020-12-03,2020-12-07,ACTUAL,2023-01-30,2023-02-21,ACTUAL,,,,2023-01-30,2023-02-21,ACTUAL,2020-12-10,ACTUAL,2020-12-10,2022-10,2022-10-31,2022-03-07,ACTUAL,2022-03-07,2021-12-06,ACTUAL,2021-12-06,,INTERVENTIONAL,ASPEN,The study was designed as a sequential Phase 2B/3 trial whereby both trial phases were nested in a common protocol. When the 2B top line results dictated substantial design changes for progression to Phase 3 the study was concluded as a Phase 2 trial.,"Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19","Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (ASPEN-COVID-19)",COMPLETED,,PHASE2/PHASE3,160.0,ACTUAL,"ARCA Biopharma, Inc.",,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,INDUSTRY,,,,,,,2022,1.0
NCT05095246,,2021-08-27,,,2023-08-09,2021-10-14,2021-10-27,ACTUAL,,,,,,,2023-08-09,2023-08-14,ACTUAL,2022-03-08,ACTUAL,2022-03-08,2023-08,2023-08-31,2024-10-30,ESTIMATED,2024-10-30,2024-07-01,ESTIMATED,2024-07-01,,INTERVENTIONAL,,,A Study of Inhaled KB407 for the Treatment of Cystic Fibrosis,"A Phase I Study of Inhaled KB407, a Replication-Incompetent, Non-Integrating Vector Expressing Human Cystic Fibrosis Transmembrane Conductance Regulator (CFTR), for the Treatment of Cystic Fibrosis",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Krystal Biotech, Inc.",,3.0,,"Pandemic, logistical, and recruitment challenges",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,INDUSTRY,,,,,,,2024,0.0
NCT05671653,,2022-12-19,,,2023-12-19,2023-01-03,2023-01-05,ACTUAL,,,,,,,2023-12-19,2023-12-26,ACTUAL,2023-01-19,ACTUAL,2023-01-19,2023-12,2023-12-31,2023-11-03,ACTUAL,2023-11-03,2023-11-03,ACTUAL,2023-11-03,,INTERVENTIONAL,,,"A Study to Evaluate the Effect of the Experimental GLP-1 Drug PF-07081532 on Blood Levels of Common Birth Control Pills, and Drugs Omeprazole and Midazolam, and Effect of GLP-1 Drug Semaglutide on Midazolam Blood Levels in Healthy Adults With Weight in the Obesity Range","A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE EFFECT OF TWO STEADY-STATE DOSE LEVELS OF PF-07081532 ON THE PHARMACOKINETICS OF SINGLE-DOSE MIDAZOLAM, OMEPRAZOLE AND AN ORAL CONTRACEPTIVE, AND THE EFFECT OF STEADY-STATE SEMAGLUTIDE ON THE PHARMACOKINETICS OF SINGLE-DOSE MIDAZOLAM, IN OBESE ADULT FEMALE PARTICIPANTS",TERMINATED,,PHASE1,32.0,ACTUAL,Pfizer,,2.0,,The decision to terminate clinical development of lotiglipron is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,INDUSTRY,,,,,,,2023,0.0
NCT03684044,,2018-09-24,2020-09-09,,2020-12-14,2018-09-24,2018-09-25,ACTUAL,2020-11-26,2020-11-30,ACTUAL,,,,2020-12-14,2021-01-06,ACTUAL,2019-01-08,ACTUAL,2019-01-08,2020-12,2020-12-31,2020-03-16,ACTUAL,2020-03-16,2020-03-16,ACTUAL,2020-03-16,,INTERVENTIONAL,,,Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza,"A Phase III, Randomized, Double-Blind Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination With Standard-of-Care Neuraminidase Inhibitor in Hospitalized Participants With Severe Influenza",COMPLETED,,PHASE3,363.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,INDUSTRY,,,,,,,2020,1.0
NCT05427630,,2022-06-17,,,2024-04-28,2022-06-17,2022-06-22,ACTUAL,,,,,,,2024-04-28,2024-04-30,ACTUAL,2023-02-15,ACTUAL,2023-02-15,2024-04,2024-04-30,2024-06-01,ESTIMATED,2024-06-01,2024-06-01,ESTIMATED,2024-06-01,,INTERVENTIONAL,,,Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment,"Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Pilot, Randomized, Double-blind, Placebo-controlled, Crossover, Dose-ranging Trial",SUSPENDED,,PHASE2,20.0,ESTIMATED,"University of California, San Diego",,4.0,,Inadequate funding,f,,,,t,t,f,,,,,,Beginning 1 year and ending 5 years after article publication,Researchers who provide a methodologically sound proposal. Proposals should be sent to nmschuster@health.ucsd.edu,,YES,Deidentified data will be shared in a manner TBD based on funding availability and journal requirements,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,OTHER,,,,,,,2024,0.0
NCT03882918,,2019-03-18,,,2022-01-20,2019-03-18,2019-03-20,ACTUAL,,,,,,,2022-01-20,2022-02-04,ACTUAL,2019-01-31,ACTUAL,2019-01-31,2022-01,2022-01-31,2021-06-30,ACTUAL,2021-06-30,2021-06-04,ACTUAL,2021-06-04,,INTERVENTIONAL,ELARA,,"An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals With Angelman Syndrome","An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals With Angelman Syndrome",TERMINATED,,PHASE3,125.0,ACTUAL,Ovid Therapeutics Inc.,,1.0,,Company decision,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,INDUSTRY,,,,,,,2021,0.0
NCT04767698,,2021-02-18,2023-02-07,,2023-02-07,2021-02-22,2021-02-23,ACTUAL,2023-02-07,2023-03-07,ACTUAL,,,,2023-02-07,2023-03-07,ACTUAL,2021-10-01,ACTUAL,2021-10-01,2023-02,2023-02-28,2022-05-10,ACTUAL,2022-05-10,2022-05-10,ACTUAL,2022-05-10,,INTERVENTIONAL,,No data was collected because the trial was prematurely terminated,Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple Sclerosis,Addition of Belimumab to B-cell Depletion to Produce Prolonged Remission of Relapsing-remitting Multiple Sclerosis Disease Activity,TERMINATED,,PHASE2,4.0,ACTUAL,Johns Hopkins University,Study was prematurely terminated and therefore there was no data collected nor analysis performed.,2.0,,The funding source decided to stop funding the study.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,OTHER,,,,,,,2022,0.0
NCT04373603,,2020-04-28,,,2022-07-21,2020-05-01,2020-05-04,ACTUAL,,,,,,,2022-07-21,2022-07-26,ACTUAL,2022-07,ESTIMATED,2022-07-31,2022-07,2022-07-31,2023-07,ESTIMATED,2023-07-31,2023-07,ESTIMATED,2023-07-31,,INTERVENTIONAL,,,Use of Tranexamic Acid in Facial Fillers,Randomized Controlled Trial Evaluating the Co-Administration of HA and TXA in Facial Filler,WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of Wisconsin, Madison",,2.0,,"Study closed prior to opening to enrollment, due to funding availability for study",f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,OTHER,,,,,,,2023,0.0
NCT04734873,,2021-01-29,2022-07-29,,2022-09-07,2021-01-29,2021-02-02,ACTUAL,2022-07-29,2022-08-23,ACTUAL,,,,2022-09-07,2022-09-21,ACTUAL,2021-02-25,ACTUAL,2021-02-25,2022-09,2022-09-30,2021-08-18,ACTUAL,2021-08-18,2021-08-18,ACTUAL,2021-08-18,,INTERVENTIONAL,,42 participants were randomized however only 40 received study treatment.,CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients,"Phase 3, Randomized, Placebo Controlled, Double-blind, Multicenter, Stratified Study of CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients",TERMINATED,,PHASE3,46.0,ACTUAL,"Corvus Pharmaceuticals, Inc.","The study was terminated due to enrollment difficulties and, as a result, some of the originally planned efficacy analyses could not be performed.",3.0,,Sponsor decision. Not related to safety issues.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,INDUSTRY,,,,,,,2021,0.0
NCT03198078,,2017-06-20,2023-11-29,,2023-11-29,2017-06-21,2017-06-23,ACTUAL,2023-11-29,2023-12-20,ACTUAL,,,,2023-11-29,2023-12-20,ACTUAL,2017-06-30,ACTUAL,2017-06-30,2023-11,2023-11-30,2023-04-03,ACTUAL,2023-04-03,2023-04-03,ACTUAL,2023-04-03,,INTERVENTIONAL,,Randomized sample included all participants who were randomized into the trial.,Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia,"A Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial to Evaluate the Efficacy of Brexpiprazole Monotherapy for the Treatment in Adolescents (13-17 Years Old) With Schizophrenia",COMPLETED,,PHASE3,316.0,ACTUAL,"Otsuka Pharmaceutical Development & Commercialization, Inc.",,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:31:48.724521,2024-10-15 08:31:48.724521,INDUSTRY,,,,,,,2023,1.0
NCT04035668,,2019-07-08,2022-11-21,2022-08-23,2023-01-27,2019-07-24,2019-07-29,ACTUAL,2022-11-21,2022-12-20,ACTUAL,2022-08-23,2022-08-26,ACTUAL,2023-01-27,2023-01-30,ACTUAL,2019-07-12,ACTUAL,2019-07-12,2023-01,2023-01-31,2021-11-23,ACTUAL,2021-11-23,2021-11-23,ACTUAL,2021-11-23,,INTERVENTIONAL,LOUiSSe,,A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome,"An Adaptive Phase 2 Randomized Double-blind, Placebo-controlled Multi-center Study to Evaluate the Safety and Efficacy of Multiple LOU064 Doses in Patients With Moderate to Severe Sjögren's Syndrome (LOUiSSe)",TERMINATED,,PHASE2,73.0,ACTUAL,Novartis,,3.0,,Sponsor's decision,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,INDUSTRY,,,,,,,2021,0.0
NCT03694197,,2018-09-06,2021-04-06,,2021-05-20,2018-10-01,2018-10-03,ACTUAL,2021-05-20,2021-06-15,ACTUAL,,,,2021-05-20,2021-06-15,ACTUAL,2018-09-28,ACTUAL,2018-09-28,2021-05,2021-05-31,2020-04-08,ACTUAL,2020-04-08,2020-04-08,ACTUAL,2020-04-08,,INTERVENTIONAL,,Demographic and other baseline characteristics were based on the data collected in R727-CL-1532 (NCT02957682). The baseline value was generally defined as the last available value before the first dose of double-blind study treatment in that study.,Long Term Safety Study of PRALUENT,Long Term Safety Study of PRALUENT in Patients With Heterozygous Familial Hypercholesterolemia or With Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk and Previously Enrolled in the Neurocognitive Function Trial,TERMINATED,,PHASE4,1389.0,ACTUAL,Regeneron Pharmaceuticals,,1.0,,The primary objective (to evaluate the long-term safety of Praluent) was adequately evaluated in other studies.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,INDUSTRY,,,,,,,2020,0.0
NCT04862416,,2021-04-26,,,2022-07-06,2021-04-26,2021-04-28,ACTUAL,,,,,,,2022-07-06,2022-07-07,ACTUAL,2021-05-17,ACTUAL,2021-05-17,2022-07,2022-07-31,2022-06-29,ACTUAL,2022-06-29,2022-06-29,ACTUAL,2022-06-29,,INTERVENTIONAL,STOP-TRANS,,Safety and Efficacy of R0.6C Vaccine,"Safety, Tolerability and Plasmodium Falciparum Transmission-reducing Activity of R0.6C Vaccine Adjuvanted With Alhydrogel Alone or Combined With Matrix-M in Healthy Malaria-naïve Adults in the Netherlands",COMPLETED,,PHASE1,32.0,ACTUAL,Radboud University Medical Center,,8.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,OTHER,,,,,,,2022,1.0
NCT03949673,,2019-04-05,2023-08-15,2021-08-24,2023-09-25,2019-05-11,2019-05-14,ACTUAL,2023-09-25,2023-10-17,ACTUAL,,2023-10-17,ACTUAL,2023-09-25,2023-10-17,ACTUAL,2019-04-08,ACTUAL,2019-04-08,2023-09,2023-09-30,2020-08-25,ACTUAL,2020-08-25,2020-08-25,ACTUAL,2020-08-25,,INTERVENTIONAL,,"Arthroplasty analysis set: All subjects who are enrolled in this study, have histological evaluation data and is based on the treatment received in their parent study (as treated).",Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip,Study to Evaluate Arthroplasty Specimens in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip,TERMINATED,,PHASE2,23.0,ACTUAL,Regeneron Pharmaceuticals,"The study was anticipated to close in Feb 2021, but ended prematurely on 25 Aug 2020 (date of global last arthroplasty surgery for last subject enrolled) due to lack of enrollment.",1.0,,Lack of enrollment,f,,,,f,t,f,,,,,,"Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.","Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, EMA, PMDA, etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).",https://vivli.org/,YES,All IPD that underlie publicly available results will be considered for sharing.,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,INDUSTRY,,,,,,,2020,0.0
NCT02534909,,2015-08-07,,,2023-01-24,2015-08-27,2015-08-28,ESTIMATED,,,,,,,2023-01-24,2023-01-26,ACTUAL,2015-09-09,ACTUAL,2015-09-09,2023-01,2023-01-31,2022-05-24,ACTUAL,2022-05-24,2022-05-24,ACTUAL,2022-05-24,,INTERVENTIONAL,,,"Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316 in Patients With Paroxysmal Nocturnal Hemoglobinuria","An Open-label Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316, an Anti-C5 Monoclonal Antibody in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)",COMPLETED,,PHASE2,10.0,ACTUAL,Novartis,,1.0,,,f,,,,f,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,INDUSTRY,,,,,,,2022,1.0
NCT03921073,,2019-04-15,2022-09-08,,2022-10-05,2019-04-16,2019-04-19,ACTUAL,2022-10-05,2022-11-01,ACTUAL,,,,2022-10-05,2022-11-01,ACTUAL,2019-08-20,ACTUAL,2019-08-20,2022-10,2022-10-31,2021-09-28,ACTUAL,2021-09-28,2021-09-28,ACTUAL,2021-09-28,,INTERVENTIONAL,,,Study of T-VEC in Locally Advanced Cutaneous Angiosarcoma,A Phase II Study of Talimogene Laherparepvec (T-VEC) in the Treatment of Locally Advanced Cutaneous Angiosarcoma,TERMINATED,,PHASE2,5.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,1.0,,Sponsor Terminated Funding,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,OTHER,,,,,,,2021,0.0
NCT03822715,,2019-01-25,,,2021-08-27,2019-01-28,2019-01-30,ACTUAL,,,,,,,2021-08-27,2021-09-01,ACTUAL,2019-03-21,ACTUAL,2019-03-21,2021-08,2021-08-31,2021-08-17,ACTUAL,2021-08-17,2021-08-17,ACTUAL,2021-08-17,,INTERVENTIONAL,NEOBREADS,,NEOBREADS: Neoadjuvant Breast Diet Study,IIT2018-25-MITA-NEOBREADS: Neoadjuvant Breast Diet Study,TERMINATED,,PHASE1,2.0,ACTUAL,Cedars-Sinai Medical Center,,1.0,,Low accrual,f,,,,f,f,f,,,,,,,,,,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2021,0.0
NCT02826681,,2016-06-30,2022-07-21,,2022-08-22,2016-07-05,2016-07-11,ESTIMATED,2022-08-22,2022-09-14,ACTUAL,,,,2022-08-22,2022-09-14,ACTUAL,2017-07-10,ACTUAL,2017-07-10,2022-08,2022-08-31,2022-07-01,ACTUAL,2022-07-01,2021-09-04,ACTUAL,2021-09-04,,INTERVENTIONAL,,,"Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia","Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in Restless Legs Syndrome Patients With Iron-deficiency Anemia",TERMINATED,,PHASE2,70.0,ACTUAL,"American Regent, Inc.",,2.0,,Lack of enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,INDUSTRY,,,,,,,2022,0.0
NCT04344548,,2020-04-10,,,2021-04-29,2020-04-10,2020-04-14,ACTUAL,,,,,,,2021-04-29,2021-05-05,ACTUAL,2020-03-30,ACTUAL,2020-03-30,2021-04,2021-04-30,2020-10-30,ACTUAL,2020-10-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,Adoptive Cell Transfer for the Immunotherapy of COVID-19 in Colombia,Phase I / II Clinical Study of Immunotherapy Based on Adoptive Cell Transfer as a Therapeutic Alternative for Patients With COVID-19 in Colombia,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Universidad Nacional de Colombia,,1.0,,The study did not get financed. Never get started.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,OTHER,,,,,,,2020,0.0
NCT03248128,,2017-08-09,2022-09-12,,2023-05-08,2017-08-09,2017-08-14,ACTUAL,2022-09-12,2022-10-12,ACTUAL,,,,2023-05-08,2023-05-09,ACTUAL,2017-10-20,ACTUAL,2017-10-20,2023-05,2023-05-31,2022-03-21,ACTUAL,2022-03-21,2022-03-21,ACTUAL,2022-03-21,,INTERVENTIONAL,,Baseline Characteristic data are reported for 902 participants who received at least 1 dose of study medication creating the ITT Population.,Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma,"A Randomised, Double-blind, Parallel Group, Multicentre, Stratified, Study Evaluating the Efficacy and Safety of Once Daily Fluticasone Furoate/Vilanterol Inhalation Powder Compared to Once Daily Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Participants Aged 5 to 17 Years Old (Inclusive) Currently Uncontrolled on Inhaled Corticosteroids",COMPLETED,,PHASE3,906.0,ACTUAL,GlaxoSmithKline,,4.0,,,f,,,,f,t,f,,,,,,IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,INDUSTRY,,,,,,,2022,1.0
NCT03572257,,2018-06-19,,,2020-04-06,2018-06-19,2018-06-28,ACTUAL,,,,,,,2020-04-06,2020-04-08,ACTUAL,2019-04-15,ACTUAL,2019-04-15,2020-04,2020-04-30,2020-03-02,ACTUAL,2020-03-02,2020-02-27,ACTUAL,2020-02-27,,INTERVENTIONAL,,,Quetiapine Treatment for Pediatric Delirium,"Prospective, Double-Blind, Randomized Controlled Trial of Quetiapine as a Treatment for Delirium in Critically Ill Children",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Medical College of Wisconsin,,2.0,,Closed due to inability to enroll,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,OTHER,,,,,,,2020,0.0
NCT04999488,,2021-07-13,,,2023-07-21,2021-08-03,2021-08-10,ACTUAL,,,,,,,2023-07-21,2023-07-24,ACTUAL,2023-12,ESTIMATED,2023-12-31,2023-07,2023-07-31,2024-12,ESTIMATED,2024-12-31,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,COQ10,,Impact of Orally Administered BPM31510 on Mitochondrial Energetics in Older Adults With Sarcopenia,Impact of Orally Administered BPM31510 on Mitochondrial Energetics in Older,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,AdventHealth Translational Research Institute,,2.0,,Drug manufacturing update. Study site will proceed with study in future.,,,,,f,t,f,,,,,,,,,,,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,OTHER,,,,,,,2024,0.0
NCT03818815,,2019-01-22,2020-07-01,,2020-08-11,2019-01-24,2019-01-28,ACTUAL,2020-07-28,2020-08-11,ACTUAL,,,,2020-08-11,2020-08-18,ACTUAL,2019-02-21,ACTUAL,2019-02-21,2020-08,2020-08-31,2020-03-26,ACTUAL,2020-03-26,2020-03-09,ACTUAL,2020-03-09,,INTERVENTIONAL,,,"A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months","A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months",COMPLETED,,PHASE2,103.0,ACTUAL,"Novus Therapeutics, Inc",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,INDUSTRY,,,,,,,2020,1.0
NCT03711318,,2018-10-16,2022-11-01,,2022-11-30,2018-10-16,2018-10-18,ACTUAL,2022-11-30,2022-12-22,ACTUAL,,,,2022-11-30,2022-12-22,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2022-11,2022-11-30,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,Participants who consented to and initiated study,Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals,Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals,TERMINATED,,PHASE3,8.0,ACTUAL,New York State Psychiatric Institute,,1.0,,continuing study was no longer feasible,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,OTHER,,,,,,,2021,0.0
NCT04305405,,2019-11-15,2023-04-06,,2023-05-16,2020-03-10,2020-03-12,ACTUAL,2023-05-16,2023-05-18,ACTUAL,,,,2023-05-16,2023-05-18,ACTUAL,2019-11-21,ACTUAL,2019-11-21,2023-05,2023-05-31,2022-09-12,ACTUAL,2022-09-12,2022-09-12,ACTUAL,2022-09-12,,INTERVENTIONAL,TATE,The Safety Analysis set consisted of all participants who received at least 1 dose of benralizumab.,PK/PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma,An Open-label Study to Evaluate the Pharmacokinetics and Pharmacodynamics and Long-term Safety of Benralizumab Administered Subcutaneously in Children With Severe Eosinophilic Asthma,COMPLETED,,PHASE3,30.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,INDUSTRY,,,,,,,2022,1.0
NCT05848843,,2023-04-28,,,2024-01-22,2023-04-28,2023-05-08,ACTUAL,,,,,,,2024-01-22,2024-01-23,ACTUAL,2023-04-25,ACTUAL,2023-04-25,2024-01,2024-01-31,2024-01-16,ACTUAL,2024-01-16,2024-01-16,ACTUAL,2024-01-16,,INTERVENTIONAL,,,A Phase I Study of Adagrasib and Durvalumab for Treatment of Advanced Non-small Cell Lung Cancers and Gastro-intestinal Cancers Harboring KRAS G12C Mutations,A Phase I Study of Adagrasib and Durvalumab for Treatment of Advanced Non-small Cell Lung Cancers and Gastro-intestinal Cancers Harboring KRAS G12C Mutations,WITHDRAWN,,PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,0 participant accrual,f,,,,t,t,f,,,f,,,,,,,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2024,0.0
NCT04650893,,2020-11-12,2023-12-13,,2024-08-20,2020-12-02,2020-12-03,ACTUAL,2024-08-20,2024-08-23,ACTUAL,,,,2024-08-20,2024-08-23,ACTUAL,2021-01-02,ACTUAL,2021-01-02,2024-08,2024-08-31,2023-12-08,ACTUAL,2023-12-08,2023-12-08,ACTUAL,2023-12-08,,INTERVENTIONAL,,Baseline was less than desired due to closure of study because follow-up was poor.,The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF,The Effect of Intravenous Non-steroidal Anti-inflammatory Drugs and Intravenous Corticosteroids on the Likelihood of Dysphagia and Dysphonia Following Anterior Cervical Discectomy and Fusion,TERMINATED,,PHASE3,33.0,ACTUAL,University of Nebraska,,3.0,,Poor compliance with data collection - too many intervals.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2023,0.0
NCT02962388,,2016-10-05,,,2021-06-28,2016-11-09,2016-11-11,ESTIMATED,,,,,,,2021-06-28,2021-06-29,ACTUAL,2017-01-03,ACTUAL,2017-01-03,2021-06,2021-06-30,2021-06-28,ACTUAL,2021-06-28,2021-06-28,ACTUAL,2021-06-28,,INTERVENTIONAL,,,The Ruxolitinib Versus Best Available Therapy Trial in Patients With High Risk ET in Second Line,"A Randomized, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Ruxolitinib Versus Best Available Therapy in Patients With High Risk Essential Thrombocythemia, Who Are Resistant or Intolerant to Hydroxyurea: A FIM Study",TERMINATED,,PHASE2/PHASE3,13.0,ACTUAL,French Innovative Leukemia Organisation,,2.0,,not enough recruitment,f,,,,t,,,,,,,,,,,YES,e crf,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,OTHER,,,,,,,2021,0.0
NCT04057365,,2019-08-13,2024-03-14,,2024-03-14,2019-08-13,2019-08-15,ACTUAL,2024-03-14,2024-04-10,ACTUAL,,,,2024-03-14,2024-04-10,ACTUAL,2019-10-07,ACTUAL,2019-10-07,2024-03,2024-03-31,2022-09-25,ACTUAL,2022-09-25,2022-09-25,ACTUAL,2022-09-25,,INTERVENTIONAL,,"Based on a Simon 2-stage design, this study did not meet response criteria to proceed beyond the safety run-in group.",Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC),A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC),TERMINATED,,PHASE2,15.0,ACTUAL,Massachusetts General Hospital,,2.0,,"Based on a Simon 2-stage design, this study did not meet response criteria to proceed to stage 2.",f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,MGH - Contact the Partners Innovations team at http://www.partners.org/innovation,http://www.partners.org/innovation,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,OTHER,,,,,,,2022,0.0
NCT04066088,,2019-08-21,,,2020-08-24,2019-08-21,2019-08-26,ACTUAL,,,,,,,2020-08-24,2020-08-26,ACTUAL,2019-12-01,ACTUAL,2019-12-01,2020-08,2020-08-31,2020-08-21,ACTUAL,2020-08-21,2020-08-21,ACTUAL,2020-08-21,,INTERVENTIONAL,,,Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome,Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome,WITHDRAWN,,PHASE4,0.0,ACTUAL,NYU Langone Health,,2.0,,PI departure from institution,,,,,f,t,f,,,,,,,,,,,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,OTHER,,,,,,,2020,0.0
NCT04871815,,2021-04-27,2021-09-27,,2022-03-07,2021-04-30,2021-05-04,ACTUAL,2021-10-05,2021-10-07,ACTUAL,,,,2022-03-07,2022-03-09,ACTUAL,2021-04-27,ACTUAL,2021-04-27,2022-03,2022-03-31,2022-03-07,ACTUAL,2022-03-07,2022-03-07,ACTUAL,2022-03-07,,INTERVENTIONAL,,,Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers.,Preliminary Examination of the Effects of Sodium Pyruvate Nasal Spray (N115) on Symptoms Associated With COVID19 Long Haulers.,COMPLETED,,PHASE2/PHASE3,22.0,ACTUAL,"Cellular Sciences, inc.",,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,INDUSTRY,,,,,,,2022,1.0
NCT02589340,,2015-10-23,,,2021-03-03,2015-10-26,2015-10-28,ESTIMATED,,,,,,,2021-03-03,2021-03-05,ACTUAL,2016-01,,2016-01-31,2021-03,2021-03-31,2021-02-23,ACTUAL,2021-02-23,2021-02-23,ACTUAL,2021-02-23,,INTERVENTIONAL,BUS-PD,,"Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia","Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia",TERMINATED,,PHASE1,6.0,ACTUAL,Oregon Health and Science University,,2.0,,Low enrollment,f,,,,f,,,,,,,,,,,,,2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,OTHER,,,,,,,2021,0.0
NCT04922957,,2021-06-09,,,2024-03-12,2021-06-09,2021-06-11,ACTUAL,,,,,,,2024-03-12,2024-03-13,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2022-08,2022-08-31,2024-03-11,ACTUAL,2024-03-11,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,,,"A Phase 2b Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study, Evaluating Efficacy and Safety of Allocetra-OTS in Patients With Severe or Critical COVID-19 With Associated Acute Respiratory Distress Syndrome (ARDS)","A Phase 2b Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study, Evaluating Efficacy and Safety of Allocetra-OTS in Patients With Severe or Critical COVID-19 With Associated Acute Respiratory Distress Syndrome (ARDS)",TERMINATED,,PHASE2,12.0,ACTUAL,Enlivex Therapeutics Ltd.,,2.0,,strategic reprioritization,f,,,,t,f,f,,,,,,,,,NO,Patient data will not contain any information which would make the patient identifiable. Data will be processes and shared using patient study number only.,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,INDUSTRY,,,,,,,2024,0.0
NCT04431453,,2020-06-08,2023-11-28,,2024-01-11,2020-06-11,2020-06-16,ACTUAL,2023-11-28,2023-12-22,ACTUAL,,,,2024-01-11,2024-02-06,ACTUAL,2020-07-21,ACTUAL,2020-07-21,2024-01,2024-01-31,2023-02-10,ACTUAL,2023-02-10,2023-02-10,ACTUAL,2023-02-10,,INTERVENTIONAL,CARAVAN,The Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.,Study of Remdesivir in Participants Below 18 Years Old With COVID-19,"A Phase 2/3 Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS-5734™) in Participants From Birth to < 18 Years of Age With COVID-19",COMPLETED,,PHASE2/PHASE3,59.0,ACTUAL,Gilead Sciences,,8.0,,,t,,,,t,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gileadclinicaltrials.com/transparency-policy#Commitment,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment",2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,INDUSTRY,,NCT04323761,APPROVED_FOR_MARKETING,,,,2023,1.0
NCT03855865,,2019-02-25,,,2019-07-17,2019-02-25,2019-02-27,ACTUAL,,,,,,,2019-07-17,2019-07-19,ACTUAL,2019-07-01,ESTIMATED,2019-07-01,2019-07,2019-07-31,2020-12-31,ESTIMATED,2020-12-31,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Study of Rapastinel as Monotherapy in Major Depressive Disorder (MDD),"A Randomized, Double-blind, Placebo- and Active- Controlled, Multicenter Study of Rapastinel as Monotherapy in Major Depressive Disorder",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Naurex, Inc, an affiliate of Allergan plc",,3.0,,Business decision to stop the program.,f,,,,,t,f,,,,,,After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.,"To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.",http://www.allerganclinicaltrials.com/,YES,"Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.",2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,INDUSTRY,,,,,,,2020,0.0
NCT04285268,,2020-02-24,,,2020-06-12,2020-02-24,2020-02-26,ACTUAL,,,,,,,2020-06-12,2020-06-16,ACTUAL,2020-05-06,ESTIMATED,2020-05-06,2020-06,2020-06-30,2024-09-30,ESTIMATED,2024-09-30,2024-09-30,ESTIMATED,2024-09-30,,INTERVENTIONAL,,,"Rituximab, Venetoclax, and Bortezomib for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma","A Phase 2 Study of Rituximab, Venetoclax (ABT 199) and Bortezomib in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Rutgers, The State University of New Jersey",,1.0,,funding available,,,,,t,t,f,,,t,,,,,,,,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,OTHER,,,,,,,2024,0.0
NCT03680560,,2018-09-14,,,2020-03-27,2018-09-19,2018-09-21,ACTUAL,,,,,,,2020-03-27,2020-03-31,ACTUAL,2019-03-13,ACTUAL,2019-03-13,2020-03,2020-03-31,2020-03-12,ACTUAL,2020-03-12,2020-03-12,ACTUAL,2020-03-12,,INTERVENTIONAL,,,Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers,"A Phase 1 Study of an Autologous ACTR T Cell Product in Combination With Trastuzumab, a Monoclonal Antibody, in Subjects With HER2-Positive Advanced Malignancies",TERMINATED,,PHASE1,6.0,ACTUAL,"Cogent Biosciences, Inc.",,1.0,,Business Reasons,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,INDUSTRY,,,,,,,2020,0.0
NCT03669133,,2018-09-05,2023-05-17,,2023-07-03,2018-09-11,2018-09-13,ACTUAL,2023-07-03,2023-07-25,ACTUAL,,,,2023-07-03,2023-07-25,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2023-07,2023-07-31,2021-03-08,ACTUAL,2021-03-08,2021-03-08,ACTUAL,2021-03-08,,INTERVENTIONAL,,Three people consented to enroll in this study; one participant screen failed and two completed the study,Vitamin E for NASH Treatment in HIV Infected Individuals,Vitamin E for NASH Treatment in HIV Infected Individuals,TERMINATED,,PHASE2,3.0,ACTUAL,Indiana University,,2.0,,lack of coordinator resources and lack of access to study resources during and due to the COVID pandemic,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,OTHER,,,,,,,2021,0.0
NCT03401749,,2018-01-10,2022-02-06,,2022-04-01,2018-01-16,2018-01-17,ACTUAL,2022-03-09,2022-04-04,ACTUAL,,,,2022-04-01,2022-05-02,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2022-04,2022-04-30,2020-12-01,ACTUAL,2020-12-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,,,Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients,Efficacy of Preadmission Theraworx Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients: A Randomized Controlled Trial,TERMINATED,,PHASE4,203.0,ACTUAL,University of Alabama at Birmingham,,3.0,,"Funding issues, poor recruiting and compliance of the patients.",f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,OTHER,,,,,,,2020,0.0
NCT03599362,,2018-07-10,2021-06-17,,2021-09-22,2018-07-23,2018-07-26,ACTUAL,2021-09-22,2021-10-19,ACTUAL,,,,2021-09-22,2021-10-19,ACTUAL,2018-07-31,ACTUAL,2018-07-31,2021-09,2021-09-30,2020-06-15,ACTUAL,2020-06-15,2020-06-15,ACTUAL,2020-06-15,,INTERVENTIONAL,,,"Study of Nivolumab, Cabiralizumab, and Stereotactic Body Radiotherapy (SBRT) for Locally Advanced Unresectable Pancreatic Cancer","Nivolumab, Cabiralizumab, and Stereotactic Body Radiotherapy (SBRT) for Locally Advanced Unresectable Pancreatic Cancer",TERMINATED,,PHASE2,7.0,ACTUAL,NYU Langone Health,,1.0,,PI departure from institution,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,OTHER,,,,,,,2020,0.0
NCT00549848,,2007-10-25,2021-08-23,,2022-07-26,2007-10-25,2007-10-26,ESTIMATED,2022-01-14,2022-02-10,ACTUAL,,,,2022-07-26,2022-08-23,ACTUAL,2007-10-29,ACTUAL,2007-10-29,2022-07,2022-07-31,2022-03-26,ACTUAL,2022-03-26,2020-09-26,ACTUAL,2020-09-26,,INTERVENTIONAL,,,Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia,Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia,COMPLETED,,PHASE3,600.0,ACTUAL,St. Jude Children's Research Hospital,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,OTHER,,,,,,,2022,1.0
NCT04386239,,2020-05-07,,,2023-02-01,2020-05-12,2020-05-13,ACTUAL,,,,,,,2023-02-01,2023-02-03,ACTUAL,2021-01-01,ACTUAL,2021-01-01,2023-02,2023-02-28,2023-01-01,ACTUAL,2023-01-01,2023-01-01,ACTUAL,2023-01-01,,INTERVENTIONAL,,,Study on the Use of Sarilumab in Patients With COVID-19 Infection,Pilot Study on the Use of Sarilumab in Patients With COVID-19 Infection,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,ASST Fatebenefratelli Sacco,,1.0,,Technical impasse from IRB,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2023,0.0
NCT01496118,,2011-12-15,2021-11-16,,2022-01-04,2011-12-20,2011-12-21,ESTIMATED,2022-01-04,2022-02-02,ACTUAL,,,,2022-01-04,2022-02-02,ACTUAL,2011-12,,2011-12-31,2022-01,2022-01-31,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,,"Participants with a Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 are included in this study. Performance status (PS) measures how well patients are able to perform their daily activities and care for themselves and has a scale of 0-5, where PS 0 being normal activity and PS 5 being dead.",Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma,Phase I/II Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma,COMPLETED,,PHASE1/PHASE2,80.0,ACTUAL,"SCRI Development Innovations, LLC",,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,OTHER,,,,,,,2020,1.0
NCT05996744,,2023-08-14,,,2024-03-22,2023-08-14,2023-08-18,ACTUAL,,,,,,,2024-03-22,2024-03-26,ACTUAL,2023-12-26,ACTUAL,2023-12-26,2024-03,2024-03-31,2024-02-23,ACTUAL,2024-02-23,2024-02-23,ACTUAL,2024-02-23,,INTERVENTIONAL,,,Study of Obeldesivir in Children and Adolescents With COVID-19,"A Phase 2/3 Single-Arm, Open-label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Obeldesivir in Pediatric Participants With COVID-19",TERMINATED,,PHASE2/PHASE3,3.0,ACTUAL,Gilead Sciences,,1.0,,Study was terminated by Sponsor and the decision was not due to any safety or efficacy reasons.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,INDUSTRY,,,,,,,2024,0.0
NCT03167619,,2017-05-23,2022-06-30,,2022-08-17,2017-05-24,2017-05-30,ACTUAL,2022-08-17,2022-09-13,ACTUAL,,,,2022-08-17,2022-09-13,ACTUAL,2018-10-04,ACTUAL,2018-10-04,2022-06,2022-06-30,2022-06-30,ACTUAL,2022-06-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,DORA,,Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA),Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer,COMPLETED,,PHASE2,45.0,ACTUAL,Duke University,,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,OTHER,,,,,,,2022,1.0
NCT05004077,,2021-08-02,2023-10-03,,2023-10-26,2021-08-12,2021-08-13,ACTUAL,2023-10-26,2023-11-18,ACTUAL,,,,2023-10-26,2023-11-18,ACTUAL,2021-11-02,ACTUAL,2021-11-02,2023-10,2023-10-31,2022-10-10,ACTUAL,2022-10-10,2022-10-10,ACTUAL,2022-10-10,,INTERVENTIONAL,RADICAL,,Repeated Amiodarone Dosing In Cardiac surgicaL Procedures,Repeated Amiodarone Dosing In Cardiac surgicaL Procedures,TERMINATED,,PHASE4,3.0,ACTUAL,University of Kentucky,,2.0,,limited enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,OTHER,,,,,,,2022,0.0
NCT04358549,,2020-04-16,2022-03-22,2021-09-30,2022-03-25,2020-04-21,2020-04-24,ACTUAL,2022-03-25,2022-03-29,ACTUAL,2022-03-25,2022-03-29,ACTUAL,2022-03-25,2022-03-29,ACTUAL,2020-04-17,ACTUAL,2020-04-17,2022-03,2022-03-31,2020-10-30,ACTUAL,2020-10-30,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,,Intent-to-Treat (ITT) population,Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19,"Open Label, Randomized, Controlled Phase 2 Proof-of-Concept Study of the Use of Favipiravir Compared to Standard of Care in Hospitalized Subjects With COVID-19",COMPLETED,,PHASE2,50.0,ACTUAL,"Fujifilm Pharmaceuticals U.S.A., Inc.",,2.0,,,,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,INDUSTRY,,,,,,,2020,1.0
NCT03618134,,2018-07-12,,,2023-11-15,2018-08-03,2018-08-07,ACTUAL,,,,,,,2023-11-15,2023-11-18,ACTUAL,2018-10-04,ACTUAL,2018-10-04,2023-11,2023-11-30,2023-06-30,ACTUAL,2023-06-30,2023-06-30,ACTUAL,2023-06-30,,INTERVENTIONAL,,,Stereotactic Body Radiation Therapy and Durvalumab With or Without Tremelimumab Before Surgery in Treating Participants With Human Papillomavirus Positive Oropharyngeal Squamous Cell Caner,Phase Ib/II Trial of Stereotactic Body Radiotherapy (SBRT) in Cominbation With Immunotherapy Prior to Transoral Robotic Surgery (TORS) for Human Papillomavirus Positive (HPV+) Squamous Cell Carcinoma of the Head and Neck (SCCHN),TERMINATED,,PHASE1/PHASE2,19.0,ACTUAL,Jonsson Comprehensive Cancer Center,,2.0,,slow accrual,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,OTHER,,,,,,,2023,0.0
NCT03641703,,2018-07-27,,,2023-07-18,2018-08-20,2018-08-22,ACTUAL,,,,,,,2023-07-18,2023-07-20,ACTUAL,2018-07-10,ACTUAL,2018-07-10,2023-07,2023-07-31,2023-05-24,ACTUAL,2023-05-24,2023-05-24,ACTUAL,2023-05-24,,INTERVENTIONAL,,,A Long-Term Follow-Up Study of Haemophilia B Patients Who Have Undergone Gene Therapy,"An Open-Label, Multicentre, Long-Term Follow-Up Study to Investigate the Safety and Durability of Response Following Dosing of a Novel Adeno-Associated Viral Vector (FLT180a) in Patients With Haemophilia B",TERMINATED,,PHASE1/PHASE2,10.0,ACTUAL,Freeline Therapeutics,,1.0,,Freeline has decided to pause development of FLT180a for business priorities,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,INDUSTRY,,,,,,,2023,0.0
NCT03333551,,2017-10-13,,,2023-05-08,2017-11-02,2017-11-07,ACTUAL,,,,,,,2023-05-08,2023-05-09,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2023-05,2023-05-31,2023-05-08,ACTUAL,2023-05-08,2023-05-08,ACTUAL,2023-05-08,,INTERVENTIONAL,,,Cardiac Uptake of 18F Florbetapir in Patients Undergoing Chemotherapy,A Pilot Study to Evaluate 18F Florbetapir Binding to Cardiac Amyloid in Patients Undergoing Chemotherapy,TERMINATED,,PHASE4,3.0,ACTUAL,Medical College of Wisconsin,,1.0,,slow recruitment.,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,OTHER,,,,,,,2023,0.0
NCT05532163,,2022-09-05,,,2024-06-20,2022-09-05,2022-09-08,ACTUAL,,,,,,,2024-06-20,2024-06-21,ACTUAL,2023-01-23,ACTUAL,2023-01-23,2024-06,2024-06-30,2023-10-09,ACTUAL,2023-10-09,2023-10-09,ACTUAL,2023-10-09,,INTERVENTIONAL,,,A Study to Investigate the Radiological Onset of Action After Treatment Initiation With Subcutaneous (SC) Natalizumab in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS),"A Prospective, Multicenter, Interventional, Open-Label, Single-arm Phase IV Study Over 24 Weeks to Investigate the Radiological Onset of Action After Treatment Initiation With Subcutaneous Natalizumab in Patients With Relapsing-Remitting Multiple Sclerosis (TYS-ON)",TERMINATED,,PHASE4,1.0,ACTUAL,Biogen,,1.0,,Sponsor's decision,f,,,,f,f,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,INDUSTRY,,,,,,,2023,0.0
NCT04840667,,2020-07-07,2023-12-15,,2024-06-14,2021-04-09,2021-04-12,ACTUAL,2024-06-14,2024-06-17,ACTUAL,,,,2024-06-14,2024-06-17,ACTUAL,2021-12-28,ACTUAL,2021-12-28,2024-06,2024-06-30,2022-12-16,ACTUAL,2022-12-16,2022-12-16,ACTUAL,2022-12-16,,INTERVENTIONAL,,"A total of 17 participants were screened and signed informed consent but none of the participants received any treatment due to screen failures. The study was terminated by the sponsor due to enrolment challenges and no participants were treated, therefore no data were evaluated and collected to be reported in this study.",A Study of Replagal in Treatment-naïve Adults With Fabry Disease,"A Phase 3, Open-label Study to Evaluate the Efficacy and Safety of REPLAGAL® in Treatment-naïve Subjects With Fabry Disease",TERMINATED,,PHASE3,17.0,ACTUAL,Takeda,"The study was terminated by the Sponsor due to enrolment challenges. No participants were evaluated, and no data were collected to be reported in this study.",1.0,,"Study closed due to enrolment challenges, not for any safety issues",f,,,,f,f,f,,,,,,,,,NO,"The study was terminated by the Sponsor due to enrolment challenges. No participants were evaluated, and no data were collected.",2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,INDUSTRY,,,,,,,2022,0.0
NCT04359329,,2020-04-21,,,2021-11-16,2020-04-22,2020-04-24,ACTUAL,,,,,,,2021-11-16,2021-11-26,ACTUAL,2020-04-20,ACTUAL,2020-04-20,2020-04,2020-04-30,2020-07-30,ACTUAL,2020-07-30,2020-07-30,ACTUAL,2020-07-30,,INTERVENTIONAL,,,Estrogen Patch for COVID-19 Symptoms,Phase II Clinical Trial of Estradiol to Reduce Severity of COVID19 Infection in COVID19+ and Presumptive COVID19+ Patients,TERMINATED,,PHASE2,2.0,ACTUAL,Stony Brook University,,2.0,,Poor accrual,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2020,0.0
NCT01554410,,2012-03-08,,,2022-02-16,2012-03-14,2012-03-15,ESTIMATED,,,,,,,2022-02-16,2022-02-17,ACTUAL,2010-08,,2010-08-31,2022-02,2022-02-28,2020-08-01,ACTUAL,2020-08-01,2019-07-16,ACTUAL,2019-07-16,,INTERVENTIONAL,,,Intensity Modulated Radiation Therapy With Cisplatin and Gemcitabine to Treat Locally Advanced Cervical Carcinoma,A Phase I Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin and Escalating Gemcitabine for Locally Advanced Cervical Carcinoma,COMPLETED,,PHASE1,35.0,ACTUAL,"University of California, San Diego",,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,OTHER,,,,,,,2020,1.0
NCT05392959,,2022-05-23,,,2024-04-24,2022-05-23,2022-05-26,ACTUAL,,,,,,,2024-04-24,2024-04-26,ACTUAL,2022-06-06,ACTUAL,2022-06-06,2024-04,2024-04-30,2023-07-17,ACTUAL,2023-07-17,2023-07-17,ACTUAL,2023-07-17,,INTERVENTIONAL,DAPAMICRO,,Effect of the Antidiabetic Drug Dapagliflozin on the Coronary Macrovascular and Microvascular Function in Type 2 Diabetic Patients,Effect of the Antidiabetic Drug DAPAgliflozin on the Coronary Macrovascular and MICROvascular Function in Type 2 Diabetic Patients,TERMINATED,,PHASE4,4.0,ACTUAL,Centre Hospitalier Universitaire Saint Pierre,,2.0,,recruitment too slow,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,OTHER,,,,,,,2023,0.0
NCT03946462,,2019-05-07,,,2021-11-18,2019-05-09,2019-05-10,ACTUAL,,,,,,,2021-11-18,2021-12-01,ACTUAL,2021-10,ESTIMATED,2021-10-31,2021-11,2021-11-30,2023-03,ESTIMATED,2023-03-31,2022-10,ESTIMATED,2022-10-31,,INTERVENTIONAL,,,Nitric Oxide During CPB to Reduce AKI in Neonates,A Prospective Randomized Controlled Trial of Supplemental Nitric Oxide During Cardiopulmonary Bypass to Reduce Acute Kidney Injury After Cardiac Surgery,WITHDRAWN,,PHASE1,0.0,ACTUAL,Baylor College of Medicine,,2.0,,This study could not be started because of some technical issues.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,OTHER,,,,,,,2023,0.0
NCT05761041,,2023-02-14,,,2023-07-18,2023-02-27,2023-03-09,ACTUAL,,,,,,,2023-07-18,2023-07-20,ACTUAL,2022-03-28,ACTUAL,2022-03-28,2023-07,2023-07-31,2023-04-15,ACTUAL,2023-04-15,2023-03-30,ACTUAL,2023-03-30,,INTERVENTIONAL,,,Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification in Arresting Early Childhood Caries,Effectiveness of Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification for Arresting Early Childhood Caries: A Randomized Clinical Trial,COMPLETED,,PHASE3,140.0,ACTUAL,Alexandria University,,2.0,,,f,,,,,t,f,,,t,,,,,,NO,,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,OTHER,,,,,,,2023,1.0
NCT04246554,,2020-01-24,2021-10-18,,2021-11-24,2020-01-28,2020-01-29,ACTUAL,2021-11-24,2021-12-21,ACTUAL,,,,2021-11-24,2021-12-21,ACTUAL,2019-05-21,ACTUAL,2019-05-21,2021-11,2021-11-30,2021-01-01,ACTUAL,2021-01-01,2020-10-09,ACTUAL,2020-10-09,,INTERVENTIONAL,,,Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery,Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery,COMPLETED,,PHASE3,49.0,ACTUAL,University Hospitals Cleveland Medical Center,"This is a single-institution study involving only five surgeons, so patient demographics and outcomes may not reflect a broader population. Neither surgeons nor patients were blinded with regards to medication use. Therefore, subjective pain scores may have been influenced by perceptions of greater pain control in patients who received ketorolac in addition to oxycodone-acetaminophen. The study may be underpowered with regards to functional outcome scores and medication side effects profiles.",2.0,,,f,,,,,t,f,,,t,,,,,,,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,OTHER,,,,,,,2021,1.0
NCT02248701,,2014-09-22,2023-08-29,2022-07-20,2023-09-27,2014-09-22,2014-09-25,ESTIMATED,2023-09-27,2023-09-29,ACTUAL,2022-07-20,2022-07-28,ACTUAL,2023-09-27,2023-09-29,ACTUAL,2017-04-27,ACTUAL,2017-04-27,2023-09,2023-09-30,2021-08-13,ACTUAL,2021-08-13,2021-08-13,ACTUAL,2021-08-13,,INTERVENTIONAL,,,Testosterone Plus Finasteride Treatment After Spinal Cord Injury,Higher-Than-Replacement Testosterone Plus Finasteride Treatment After SCI,TERMINATED,,PHASE2,33.0,ACTUAL,VA Office of Research and Development,This trial was terminated early due to enrollment and retention difficulties that persisted during the severe acute respiratory syndrome (SARS)-Cov19 pandemic. This resulted in a smaller number of subjects being enrolled and undergoing testing than was originally planned in our a priori analysis.,2.0,,Enrollment difficulties,f,,,,t,t,f,,,f,,,"Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research \& Development.","Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research \& Development.",,YES,"Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research \& Development.",2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,FED,,,,,,,2021,0.0
NCT04134143,,2019-10-18,,,2021-01-12,2019-10-18,2019-10-22,ACTUAL,,,,,,,2021-01-12,2021-01-14,ACTUAL,2019-11-07,ACTUAL,2019-11-07,2021-01,2021-01-31,2020-12-30,ACTUAL,2020-12-30,2020-11-25,ACTUAL,2020-11-25,,INTERVENTIONAL,,,Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers,"An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft- C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers",TERMINATED,,PHASE1,6.0,ACTUAL,Mallinckrodt,,3.0,,Business decision - not related to product quality or safety concerns,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,INDUSTRY,,,,,,,2020,0.0
NCT03602495,,2018-07-18,,,2021-11-29,2018-07-18,2018-07-26,ACTUAL,,,,,,,2021-11-29,2021-12-13,ACTUAL,2018-08-29,ACTUAL,2018-08-29,2021-11,2021-11-30,2021-07-15,ACTUAL,2021-07-15,2021-02-28,ACTUAL,2021-02-28,,INTERVENTIONAL,DTC,,A Phase 3 Study of Donafenib in Patients With Radioiodine-refractory Differentiated Thyroid Cancer,"A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Donafenib in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer",TERMINATED,,PHASE3,204.0,ACTUAL,"Suzhou Zelgen Biopharmaceuticals Co.,Ltd",,2.0,,"Based on IDMC's recommendations during the interim analysisthe trial has reached the goal of early termination of the trial. the sponsor communicating with CDE, CDE agreed to unblind the trial and submit a NDA.",f,,,,t,f,f,,,,,,,,,,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,INDUSTRY,,,,,,,2021,0.0
NCT03329508,,2017-10-30,2022-10-30,,2023-03-15,2017-10-30,2017-11-06,ACTUAL,2023-03-15,2023-03-21,ACTUAL,,,,2023-03-15,2023-03-21,ACTUAL,2018-01-19,ACTUAL,2018-01-19,2022-06,2022-06-30,2021-10-31,ACTUAL,2021-10-31,2021-08-23,ACTUAL,2021-08-23,,INTERVENTIONAL,,"The dispensing of the investigational product was based on a just-in-time shipping strategy per subject. Randomization was done at the end of the Screening period and before the Baseline Visit to allow for shipping of the kit to the site. Twenty-five (25) subjects were enrolled and randomized into treatment groups, but withdrew from study prior to first dose. They did not came to baseline visit , receive study drug nor did they receive a post-randomization evaluation.",A Phase 3 Study With P2B001 in Subjects With Early Parkinson's,"A Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.",COMPLETED,,PHASE3,544.0,ACTUAL,Pharma Two B Ltd.,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,INDUSTRY,,,,,,,2021,1.0
NCT03040024,,2017-01-31,2021-02-24,,2021-07-07,2017-01-31,2017-02-01,ESTIMATED,2021-02-24,2021-03-19,ACTUAL,,,,2021-07-07,2021-07-08,ACTUAL,2017-03-17,ACTUAL,2017-03-17,2021-07,2021-07-31,2020-04-24,ACTUAL,2020-04-24,2020-02-24,ACTUAL,2020-02-24,,INTERVENTIONAL,,,"Delirium Prevention With Ketamine in Ear, Nose, and Throat (ENT) Patients",A Randomized Placebo-controlled Pilot Study of Single-dose Intraoperative Ketamine for the Prevention of Delirium in Otolaryngeal Cancer Surgery Patients,TERMINATED,,PHASE4,71.0,ACTUAL,Emory University,,3.0,,Halted due to COVID 19; we believe we have adequate data for analysis,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,OTHER,,,,,,,2020,0.0
NCT05047770,,2021-09-15,2023-08-28,,2023-10-19,2021-09-15,2021-09-17,ACTUAL,2023-10-19,2023-11-13,ACTUAL,,,,2023-10-19,2023-11-13,ACTUAL,2021-10-07,ACTUAL,2021-10-07,2023-10,2023-10-31,2022-08-31,ACTUAL,2022-08-31,2022-08-29,ACTUAL,2022-08-29,,INTERVENTIONAL,,,A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine,"A Phase III, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Immune Response and Safety of Both Herpes Zoster Subunit Vaccine in Healthy Adults Aged 50 Years and Older AND the Influenza Virus Vaccine in Healthy Adults Aged 18 Years and Older When Administered Sequentially or Coadministered With mRNA-1273 Booster Vaccination",COMPLETED,,PHASE3,2013.0,ACTUAL,GlaxoSmithKline,,4.0,,,f,,,,f,t,f,,,f,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://www.gsk.com/en-gb/innovation/trials/data-transparency,YES,Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,INDUSTRY,,,,,,,2022,1.0
NCT04327401,,2020-03-26,,,2020-08-05,2020-03-27,2020-03-31,ACTUAL,,,,,,,2020-08-05,2020-08-07,ACTUAL,2020-04-13,ACTUAL,2020-04-13,2020-08,2020-08-31,2020-07-22,ACTUAL,2020-07-22,2020-07-22,ACTUAL,2020-07-22,,INTERVENTIONAL,CoDEX,,COVID-19-associated ARDS Treated With Dexamethasone: Alliance Covid-19 Brasil III,"COVID-19-associated ARDS Treated With DEXamethasone: an Open-label, Randomized, Controlled Trial: CoDEX (Alliance Covid-19 Brasil III)",TERMINATED,,PHASE3,299.0,ACTUAL,Hospital Sirio-Libanes,,2.0,,"The Data Monitoring Committee recommended to stop the trial based on the Recovery Trial results, which was accepted by the CoDEX Steering Committee.",f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,OTHER,,,,,,,2020,0.0
NCT03795012,,2019-01-04,,,2021-08-26,2019-01-04,2019-01-07,ACTUAL,,,,,,,2021-08-26,2021-08-31,ACTUAL,2019-04-30,ACTUAL,2019-04-30,2021-08,2021-08-31,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,,,Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients,"A Multicenter, Randomized, Phase II Trial Evaluating the Efficacy of Eribulin Monotherapy and Eribulin Plus Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients After Progression on Endocrine Therapy (REVERT)",TERMINATED,,PHASE2,22.0,ACTUAL,MedSIR,,2.0,,Slow recruitment rate,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 16:19:42.933009,2024-10-16 16:19:42.933009,OTHER,,,,,,,2021,0.0
NCT04101890,,2019-09-16,2021-10-06,,2021-11-18,2019-09-23,2019-09-24,ACTUAL,2021-11-18,2021-12-17,ACTUAL,,,,2021-11-18,2021-12-17,ACTUAL,2020-03-12,ACTUAL,2020-03-12,2021-11,2021-11-30,2021-01-02,ACTUAL,2021-01-02,2021-01-02,ACTUAL,2021-01-02,,INTERVENTIONAL,,,The Healthy Baby Bottoms Study,The Healthy Baby Bottoms Study: A Trial of Theraworx Foam Formulation for the Prevention and Treatment of Diaper Dermatitis,TERMINATED,,PHASE4,5.0,ACTUAL,Children's National Research Institute,,2.0,,Principal Investigator left the Institution and decision was made by funders to terminate the trial.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,OTHER,,,,,,,2021,0.0
NCT03383146,,2017-12-19,2021-10-05,,2021-11-19,2017-12-19,2017-12-26,ACTUAL,2021-11-19,2021-11-23,ACTUAL,,,,2021-11-19,2021-11-23,ACTUAL,2018-02-01,ACTUAL,2018-02-01,2021-11,2021-11-30,2020-11-05,ACTUAL,2020-11-05,2020-11-05,ACTUAL,2020-11-05,,INTERVENTIONAL,,Intent-to-treat (ITT) Population included all randomized participants.,A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04,"A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis",TERMINATED,,PHASE3,450.0,ACTUAL,Allergan,,2.0,,The Relamorelin program is being terminated solely based on a business decision.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,INDUSTRY,,,,,,,2020,0.0
NCT03712930,,2018-10-11,2021-08-02,,2021-10-20,2018-10-17,2018-10-19,ACTUAL,2021-10-20,2021-11-17,ACTUAL,,,,2021-10-20,2021-11-17,ACTUAL,2019-02-05,ACTUAL,2019-02-05,2021-10,2021-10-31,2020-09-02,ACTUAL,2020-09-02,2020-08-06,ACTUAL,2020-08-06,,INTERVENTIONAL,,,Treatment of Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Deficiency,"A Phase 2, Open-Label, Single-Arm Study of BGB-290 (BGB-290) for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Homologous Recombination Deficiency (HRD)",TERMINATED,,PHASE2,13.0,ACTUAL,BeiGene,,1.0,,Sponsor's decision to revisit the development approach for prostate cancer.,f,,,,,t,f,,,,,,,,,YES,,2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,INDUSTRY,,,,,,,2020,0.0
NCT03232112,,2017-07-20,,,2021-06-03,2017-07-24,2017-07-27,ACTUAL,,,,,,,2021-06-03,2021-06-04,ACTUAL,2017-08-07,ACTUAL,2017-08-07,2021-06,2021-06-30,2020-10-05,ACTUAL,2020-10-05,2020-03-15,ACTUAL,2020-03-15,,INTERVENTIONAL,EXALT,,Does Treatment With GLP-1 Reduce Alcohol Intake in Patients With Alcohol Dependence?,Does Glucagon-like Peptide (GLP-1) Receptor Agonist Stimulation Reduce Alcohol Intake in Patients With Alcohol Dependence?,COMPLETED,,PHASE2,152.0,ACTUAL,Psychiatric Centre Rigshospitalet,,2.0,,,f,,,,t,f,f,,,f,,,,,,YES,At the start and at the end of the study a blood sample (9ml) and a urine sample (7.2ml) will be stored in a biobank for future research. The patients will be asked to give a separate written consent. Using this biobank in the future will require a new approval from the Danish Data Protection Agency.,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,OTHER,,,,,,,2020,0.0
NCT03587129,,2018-07-03,,,2020-08-03,2018-07-03,2018-07-16,ACTUAL,,,,,,,2020-08-03,2020-08-05,ACTUAL,2018-07-10,ACTUAL,2018-07-10,2018-07,2018-07-31,2020-06-14,ACTUAL,2020-06-14,2020-06-14,ACTUAL,2020-06-14,,INTERVENTIONAL,,,Clinical Study of Apatinib in the Treatment of Platinum Resistant Recurrent Ovarian Cancer,Clinical Study of Apatinib in the Treatment of Platinum Resistant Recurrent Ovarian Cancer,TERMINATED,,PHASE2,1.0,ACTUAL,First Affiliated Hospital of Harbin Medical University,,1.0,,No patient enter this study.,f,,,,f,f,f,,,,,,,,,NO,The investigators have no other clinical trial about ovarian cancer,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,OTHER,,,,,,,2020,0.0
NCT04498273,,2020-08-03,2022-01-14,,2022-02-15,2020-08-03,2020-08-04,ACTUAL,2022-02-15,2022-02-17,ACTUAL,,,,2022-02-15,2022-02-17,ACTUAL,2020-09-07,ACTUAL,2020-09-07,2022-02,2022-02-28,2021-08-05,ACTUAL,2021-08-05,2021-08-05,ACTUAL,2021-08-05,,INTERVENTIONAL,,,COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80,COVID-19 Outpatient Thrombosis Prevention Trial A Multi-center Adaptive Randomized Placebo-controlled Platform Trial Evaluating the Efficacy and Safety of Anti-thrombotic Strategies in COVID Adults Not Requiring Hospitalization at Time of Diagnosis,TERMINATED,,PHASE3,657.0,ACTUAL,University of Pittsburgh,Early termination leads to a small number of subjects being analyzed.,4.0,,an event rate lower than anticipated,,,,,t,t,f,,,,,,,,,NO,,2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,OTHER,,,,,,,2021,0.0
NCT04968951,,2021-07-09,,,2024-02-22,2021-07-09,2021-07-20,ACTUAL,,,,,,,2024-02-22,2024-02-26,ACTUAL,2021-11-10,ACTUAL,2021-11-10,2024-02,2024-02-29,2022-08-22,ACTUAL,2022-08-22,2022-08-22,ACTUAL,2022-08-22,,INTERVENTIONAL,REFOCUS,,Refined Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis (UC),REFOCUS: Refined Fecal Microbiota Transplantation (FMT) Delivered by Oral Capsules for Induction of Remission in Mild to Moderate Ulcerative Colitis - a Phase I Study,TERMINATED,,EARLY_PHASE1,4.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,2.0,,insufficient funding,f,,,,t,t,f,,,,,,,,,NO,There is not a plan to make IPD available,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,OTHER,,,,,,,2022,0.0
NCT04173611,,2019-11-18,,,2021-04-30,2019-11-19,2019-11-22,ACTUAL,,,,,,,2021-04-30,2021-05-06,ACTUAL,2020-06-08,ACTUAL,2020-06-08,2021-04,2021-04-30,2020-12-07,ACTUAL,2020-12-07,2020-12-07,ACTUAL,2020-12-07,,INTERVENTIONAL,,,"Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of EXPAREL® Administered Via a Single Intrathecal Injection to Healthy Volunteers","Phase 1, Randomized, Double-Blind, Active and Placebo Controlled, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of EXPAREL® Administered Via a Single Intrathecal Injection to Healthy Volunteers.",TERMINATED,,PHASE1,20.0,ACTUAL,"Pacira Pharmaceuticals, Inc",,3.0,,Terminated for strategic and administrative reasons,f,,,,t,t,f,,,,,,,,,,,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,INDUSTRY,,,,,,,2020,0.0
NCT02662894,,2015-11-23,,,2021-02-23,2016-01-21,2016-01-26,ESTIMATED,,,,,,,2021-02-23,2021-02-24,ACTUAL,2019-10,ESTIMATED,2019-10-31,2021-02,2021-02-28,2020-12,ESTIMATED,2020-12-31,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.,Efficacy of Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.,WITHDRAWN,,PHASE3,0.0,ACTUAL,EMS,,4.0,,Sponsor decision,f,,,,f,f,f,,,,,,,,,,,2024-10-15 18:09:14.201958,2024-10-15 18:09:14.201958,INDUSTRY,,,,,,,2020,0.0
NCT03763175,,2018-11-30,2021-08-10,,2022-07-07,2018-11-30,2018-12-04,ACTUAL,2021-08-10,2021-09-05,ACTUAL,,,,2022-07-07,2022-07-13,ACTUAL,2018-12-24,ACTUAL,2018-12-24,2022-07,2022-07-31,2020-10-09,ACTUAL,2020-10-09,2020-10-09,ACTUAL,2020-10-09,,INTERVENTIONAL,,,Efficacy and Safety of SYN-010 in IBS-C,"Evaluation of the Efficacy and Safety of Single, Daily Oral Doses of SYN-010 Compared to Placebo in Adult Patients With Irritable Bowel Syndrome With Constipation (EASE-DO)",TERMINATED,,PHASE2,59.0,ACTUAL,Cedars-Sinai Medical Center,,3.0,,Interim Futility Analysis,,,,,t,t,f,,,,,,,,,,,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,OTHER,,,,,,,2020,0.0
NCT05178654,,2021-12-16,,,2022-01-20,2021-12-16,2022-01-05,ACTUAL,,,,,,,2022-01-20,2022-01-31,ACTUAL,2022-02-22,ESTIMATED,2022-02-22,2022-01,2022-01-31,2022-04-01,ESTIMATED,2022-04-01,2022-04-01,ESTIMATED,2022-04-01,,INTERVENTIONAL,,,"Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]PF-07321332 in Healthy Male Participants.","A PHASE 1, OPEN-LABEL, SINGLE-DOSE STUDY TO INVESTIGATE THE MASS BALANCE, METABOLISM AND EXCRETION OF [14C]PF-07321332 IN HEALTHY MALE PARTICIPANTS",WITHDRAWN,,PHASE1,0.0,ACTUAL,Pfizer,,1.0,,"Based on various healthy authorities feedback on PAXLOVID submission, this study is no longer required.",f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 03:57:19.412252,2024-10-17 03:57:19.412252,INDUSTRY,,,,,,,2022,0.0
NCT04814537,,2021-03-22,,,2022-08-02,2021-03-22,2021-03-24,ACTUAL,,,,,,,2022-08-02,2022-08-04,ACTUAL,2021-02-25,ACTUAL,2021-02-25,2022-08,2022-08-31,2022-03-23,ACTUAL,2022-03-23,2022-03-23,ACTUAL,2022-03-23,,INTERVENTIONAL,,,Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques,A Trial to Determine the Optimal Bupivacaine Dose for Initiation of Labor Epidural Pain Relief,COMPLETED,,PHASE4,100.0,ACTUAL,Brigham and Women's Hospital,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,OTHER,,,,,,,2022,1.0
NCT03789214,,2018-12-26,2022-05-18,,2022-07-12,2018-12-26,2018-12-28,ACTUAL,2022-07-12,2022-08-08,ACTUAL,,,,2022-07-12,2022-08-08,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2022-07,2022-07-31,2021-06-10,ACTUAL,2021-06-10,2021-06-10,ACTUAL,2021-06-10,,INTERVENTIONAL,,,Medical Management of Sleep Disturbance During Opioid Tapering,Medical Management of Sleep Disturbance During Opioid Tapering,COMPLETED,,PHASE2,90.0,ACTUAL,Johns Hopkins University,,3.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,OTHER,,,,,,,2021,1.0
NCT04085393,,2019-08-29,,,2020-09-28,2019-09-07,2019-09-11,ACTUAL,,,,,,,2020-09-28,2020-09-30,ACTUAL,2020-08-15,ACTUAL,2020-08-15,2020-09,2020-09-30,2022-12-01,ESTIMATED,2022-12-01,2020-08-15,ACTUAL,2020-08-15,,INTERVENTIONAL,,,Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Nausea and Vomiting,Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Breakthrough Nausea and Vomiting (CINV) in Patients Receiving Moderately or Highly Emetogenic Chemotherapy: A Phase II Clinical Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Alabama at Birmingham,,2.0,,sponsor withdrew study,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,OTHER,,,,,,,2022,0.0
NCT05439941,,2022-06-27,2023-07-14,,2023-08-14,2022-06-27,2022-06-30,ACTUAL,2023-08-14,2023-09-07,ACTUAL,,,,2023-08-14,2023-09-07,ACTUAL,2022-06-06,ACTUAL,2022-06-06,2023-08,2023-08-31,2023-06-07,ACTUAL,2023-06-07,2023-05-25,ACTUAL,2023-05-25,,INTERVENTIONAL,,,A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials,A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous Phase 2 And 3 EDP1815 Trials,TERMINATED,,PHASE2,287.0,ACTUAL,"Evelo Biosciences, Inc.",,3.0,,Parent Study (NCT05121480) did not meet the primary endpoint.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,INDUSTRY,,,,,,,2023,0.0
NCT03263091,,2017-08-22,2024-06-14,2024-02-28,2024-07-30,2017-08-23,2017-08-28,ACTUAL,2024-07-30,2024-08-01,ACTUAL,,2024-08-01,ACTUAL,2024-07-30,2024-08-01,ACTUAL,2018-01-29,ACTUAL,2018-01-29,2024-07,2024-07-31,2023-06-20,ACTUAL,2023-06-20,2023-03-09,ACTUAL,2023-03-09,,INTERVENTIONAL,,The safety analysis set included all participants who received at least 1 dose of study drug.,Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients With Lower Risk Myelodysplastic Syndrome (MDS) With Low Red Blood Cell (RBC) Transfusion Burden (LTB)",TERMINATED,,PHASE3,184.0,ACTUAL,FibroGen,"Study did not meet its primary efficacy endpoint; hence, the study was terminated early.",2.0,,Study did not meet its primary efficacy endpoint.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,INDUSTRY,,,,,,,2023,0.0
NCT04261036,,2020-02-06,,,2023-05-26,2020-02-06,2020-02-07,ACTUAL,,,,,,,2023-05-26,2023-05-30,ACTUAL,2019-07-20,ACTUAL,2019-07-20,2023-05,2023-05-31,2021-10-01,ESTIMATED,2021-10-01,2021-07-01,ESTIMATED,2021-07-01,,INTERVENTIONAL,,,Vitamin C for the Prevention of UTI in Women Who Undergo Elective Gynecological Surgeries,Vitamin C for the Prevention of Catheter-associated Urinary Tract Infections in Women Who Undergo Elective Gynecological Surgeries: a Study Protocol for a Randomized Double Blinded Controlled Trial.,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,American University of Beirut Medical Center,,2.0,,"Unfortunately, the economic crisis in Lebanon precluded utilization of available funding to recruit patients at the specified institution. No patients were recruited.",f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,OTHER,,,,,,,2021,0.0
NCT05584332,,2022-10-12,,,2023-07-20,2022-10-17,2022-10-18,ACTUAL,,,,,,,2023-07-20,2023-07-21,ACTUAL,2022-12-09,ACTUAL,2022-12-09,2022-10,2022-10-31,2023-03-23,ACTUAL,2023-03-23,2023-03-23,ACTUAL,2023-03-23,,INTERVENTIONAL,,,"A Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity, Safety of Quadrivalent HPV Recombinant Vaccine in Chinese Healthy Females","A Multicenter,Randomized, Placebo-Controlled, and Double-blind Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity and Safety of Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Aged 18-45 Years",TERMINATED,,PHASE3,3131.0,ACTUAL,"Shanghai Bovax Biotechnology Co., Ltd.",,2.0,,Strategic adjustment,f,,,,t,f,f,,,,,,,,,,,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,INDUSTRY,,,,,,,2023,0.0
NCT04045145,,2019-07-31,2024-06-20,2022-06-20,2024-07-17,2019-08-01,2019-08-05,ACTUAL,2024-07-17,2024-07-18,ACTUAL,,2024-07-18,ACTUAL,2024-07-17,2024-07-18,ACTUAL,2019-12-12,ACTUAL,2019-12-12,2024-07,2024-07-31,2021-07-02,ACTUAL,2021-07-02,2021-07-02,ACTUAL,2021-07-02,,INTERVENTIONAL,,All participants who received at least 1 dose of study drug.,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal Hyperplasia","A Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Pediatric Subjects With Congenital Adrenal Hyperplasia",COMPLETED,,PHASE2,8.0,ACTUAL,Neurocrine Biosciences,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,INDUSTRY,,,,,,,2021,1.0
NCT03163667,,2017-05-21,2022-07-18,2020-12-17,2022-08-19,2017-05-21,2017-05-23,ACTUAL,2022-08-19,2022-09-15,ACTUAL,2022-08-19,2022-09-15,ACTUAL,2022-08-19,2022-09-15,ACTUAL,2017-09-06,ACTUAL,2017-09-06,2022-08,2022-08-31,2020-06-01,ACTUAL,2020-06-01,2019-04-26,ACTUAL,2019-04-26,,INTERVENTIONAL,ENTRATA,,CB-839 With Everolimus vs. Placebo With Everolimus in Participants With Renal Cell Carcinoma (RCC),"A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination With Everolimus (CBE) vs. Placebo With Everolimus (PboE) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC)",COMPLETED,,PHASE2,69.0,ACTUAL,"Calithera Biosciences, Inc",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,INDUSTRY,,,,,,,2020,1.0
NCT02624856,,2015-12-01,,,2020-01-22,2015-12-04,2015-12-09,ESTIMATED,,,,,,,2020-01-22,2020-01-23,ACTUAL,2015-11,,2015-11-30,2016-08,2016-08-31,2020-01-01,ACTUAL,2020-01-01,2017-11,ESTIMATED,2017-11-30,,INTERVENTIONAL,,,Liposomal Bupivacaine Versus Standard Bupivacaine Plus Dexamethasone in Quadriceps Sparing Femoral Nerve Block and Wound Infiltration for Total Knee Arthroplasty,"Prospective, Randomized, Double-Blinded, Allocation Concealed Study Comparing the Efficacy of Liposomal Bupivacaine Over Standard Bupivacaine Plus Dexamethasone in Quadriceps Sparing Femoral Nerve Block and Wound Infiltration for Primary Total Knee Arthroplasty",WITHDRAWN,,PHASE4,0.0,ACTUAL,Albany Medical College,,2.0,,Lack of funding,f,,,,f,,,,,,,,,,,,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,OTHER,,,,,,,2020,0.0
NCT00134030,,2005-08-22,2022-11-21,,2023-05-10,2005-08-22,2005-08-24,ESTIMATED,2023-05-10,2023-06-07,ACTUAL,,,,2023-05-10,2023-06-07,ACTUAL,2005-11-14,ACTUAL,2005-11-14,2023-05,2023-05-31,2022-09-30,ACTUAL,2022-09-30,2015-01-31,ACTUAL,2015-01-31,,INTERVENTIONAL,EURAMOS-1,,"Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma",A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to Pre-operative Chemotherapy,COMPLETED,,PHASE3,1334.0,ACTUAL,Children's Oncology Group,"In the good response patients (randomised to MAP-GR or MAPifn), 128 of 357 MAPifn patients completed the planned protocol treatment. Among poor response patients (randomised to MAP-PR or MAPie), 42% of registered patients were not randomised. Further patients were registered to the trial and joined a treatment cohort for follow-up but declined to join the randomisation or were not eligible. The data for these non-randomised patients are not presented here.",4.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,NETWORK,,,,,,,2022,1.0
NCT04598321,,2020-10-16,2022-12-12,,2022-12-12,2020-10-16,2020-10-22,ACTUAL,2022-12-12,2023-10-12,ACTUAL,,,,2022-12-12,2023-10-12,ACTUAL,2021-03-29,ACTUAL,2021-03-29,2022-12,2022-12-31,2022-12-06,ACTUAL,2022-12-06,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,,,BrUOG 390: Neoadjuvant Treatment With Talazoparib,"BrUOG 390: Neoadjuvant Treatment With Talazoparib for Women With Newly Diagnosed, Advanced Ovarian Cancer Associated With a Mutation in BRCA1 or BRCA2 (mBRCA)",TERMINATED,,PHASE1,1.0,ACTUAL,Brown University,,1.0,,termination of research grant agreement,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,OTHER,,,,,,,2022,0.0
NCT04220892,,2019-11-26,,,2020-07-29,2020-01-06,2020-01-07,ACTUAL,,,,,,,2020-07-29,2020-07-31,ACTUAL,2020-07-08,ESTIMATED,2020-07-08,2020-07,2020-07-31,2020-07-08,ESTIMATED,2020-07-08,2020-07-08,ESTIMATED,2020-07-08,,INTERVENTIONAL,,,Pilot Study of Pembrolizumab Combined With Pemetrexed or Abemaciclib for High Grade Glioma,Pilot Study of Pembrolizumab Combined With Pemetrexed or Abemaciclib for the Treatment of Patients With High Grade Glioma,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Saint John's Cancer Institute,,2.0,,One of the study drugs will no longer be supplied by manufacturer and the pembrolizumab + abemaciclib study arm is removed due to toxicity seen in other trials.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 06:21:18.651917,2024-10-16 06:21:18.651917,OTHER,,,,,,,2020,0.0
NCT04804033,,2021-03-05,,,2024-08-22,2021-03-17,2021-03-18,ACTUAL,,,,,,,2024-08-22,2024-08-26,ACTUAL,2021-03-26,ACTUAL,2021-03-26,2024-08,2024-08-31,2024-03-21,ACTUAL,2024-03-21,2024-03-21,ACTUAL,2024-03-21,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention,"A Phase 2/3 Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention",TERMINATED,,PHASE2/PHASE3,538.0,ACTUAL,Pfizer,,4.0,,Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.,,,,,,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,INDUSTRY,,,,,,,2024,0.0
NCT03418805,,2018-01-08,,,2022-03-21,2018-01-25,2018-02-01,ACTUAL,,,,,,,2022-03-21,2022-04-01,ACTUAL,2017-12-11,ACTUAL,2017-12-11,2022-03,2022-03-31,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Controlled-Release Tablets 600 mg in Comparison to the Reference Standard Ibuprofen Tablets in Normal Healthy Volunteers,"A Randomized, 4-way Crossover Study to Evaluate the Food Effect and the Absorption Profile of Investigational Product of Ibuprofen Controlled-Release Tablets 600 mg in Comparison to the Reference Standard Ibuprofen Tablets 200 mg in Normal Healthy Volunteers",TERMINATED,,PHASE1,31.0,ACTUAL,"Overseas Pharmaceuticals, Ltd.",,4.0,,Sponsor's consideration of product development strategies,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,INDUSTRY,,,,,,,2020,0.0
NCT03025087,,2017-01-17,2024-05-15,,2024-07-24,2017-01-17,2017-01-19,ESTIMATED,2024-05-15,2024-06-12,ACTUAL,,,,2024-07-24,2024-08-20,ACTUAL,2017-06-19,ACTUAL,2017-06-19,2024-07,2024-07-31,2024-04-19,ACTUAL,2024-04-19,2023-05-22,ACTUAL,2023-05-22,,INTERVENTIONAL,,"Data not collected on eight participants. There was no enrollment in Phase 3, Phase 4, or Phase 5.",Hydroxychloroquine and Cognitive Function After Surgery,Hydroxychloroquine and Cognitive Function After Surgery,TERMINATED,,PHASE4,24.0,ACTUAL,Duke University,,5.0,,Showed no benefit,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,OTHER,,,,,,,2024,0.0
NCT04746339,,2021-02-08,,,2022-08-23,2021-02-08,2021-02-09,ACTUAL,,,,,,,2022-08-23,2022-08-25,ACTUAL,2021-03-04,ACTUAL,2021-03-04,2022-08,2022-08-31,2022-05-30,ACTUAL,2022-05-30,2022-05-13,ACTUAL,2022-05-13,,INTERVENTIONAL,APOLLO,,Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19,Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19 - the Apollo Trial,TERMINATED,,PHASE4,411.0,ACTUAL,Brazilian Clinical Research Institute,,2.0,,"Due to the decrease in COVID cases and in the recruitment rate, and DSMB orientation.",f,,,,t,f,f,,,,,,,,,YES,All data provided during study is anonymized to respect the privacy of patients who have participated in the trial in line with applicable regulations.,2024-10-15 08:37:49.127044,2024-10-15 08:37:49.127044,OTHER,,,,,,,2022,0.0
NCT05033561,,2021-08-19,2023-07-20,,2024-04-01,2021-08-31,2021-09-05,ACTUAL,2024-04-01,2024-08-23,ACTUAL,,,,2024-04-01,2024-08-23,ACTUAL,2021-12-16,ACTUAL,2021-12-16,2024-04,2024-04-30,2022-10-25,ACTUAL,2022-10-25,2022-05-24,ACTUAL,2022-05-24,,INTERVENTIONAL,,,Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants,A Phase III Open-label Randomized Controlled Study to Evaluate the Safety and Immunogenicity of nOPV2 at Different Intervals of Administration in Infants,COMPLETED,,PHASE3,905.0,ACTUAL,Fidec Corporation,,3.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,OTHER,,,,,,,2022,1.0
NCT02336074,,2014-10-23,2019-06-24,,2023-10-16,2015-01-07,2015-01-12,ESTIMATED,2019-08-22,2019-09-25,ACTUAL,,,,2023-10-16,2023-10-23,ACTUAL,2015-11-27,ACTUAL,2015-11-27,2023-10,2023-10-31,2023-03-31,ACTUAL,2023-03-31,2017-11-15,ACTUAL,2017-11-15,,INTERVENTIONAL,RIVER,,Research In Viral Eradication of HIV Reservoirs,Research In Viral Eradication of HIV Reservoirs,COMPLETED,,PHASE2,60.0,ACTUAL,Imperial College London,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,OTHER,,,,,,,2023,1.0
NCT01942135,,2013-09-10,2015-12-03,,2024-04-01,2013-09-10,2013-09-13,ESTIMATED,2016-04-15,2016-05-23,ESTIMATED,,,,2024-04-01,2024-04-04,ACTUAL,2013-09-26,ACTUAL,2013-09-26,2024-04,2024-04-30,2022-09-28,ACTUAL,2022-09-28,2014-12-05,ACTUAL,2014-12-05,,INTERVENTIONAL,,"The intent-to-treat (ITT) population or full analysis set included all participants who were randomized, with study intervention assignment designated according to initial randomization, regardless of whether participants received study intervention or received a different drug from that to which they were randomized.",Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3),"MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 TRIAL OF FULVESTRANT (FASLODEX (REGISTERED)). WITH OR WITHOUT PD-0332991 (PALBOCICLIB) +/- GOSERELIN IN WOMEN WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE THERAPY",COMPLETED,,PHASE3,521.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,INDUSTRY,,,,,,,2022,1.0
NCT03811574,,2019-01-18,2021-11-17,,2022-02-23,2019-01-18,2019-01-22,ACTUAL,2022-02-23,2022-03-22,ACTUAL,,,,2022-02-23,2022-03-22,ACTUAL,2019-01-21,ACTUAL,2019-01-21,2022-02,2022-02-28,2020-11-20,ACTUAL,2020-11-20,2020-11-20,ACTUAL,2020-11-20,,INTERVENTIONAL,STEP 6,Full analysis set (FAS) included all randomised participants.,STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity,Effect and Safety of Semaglutide Once-weekly in East Asian Subjects With Overweight or Obesity,COMPLETED,,PHASE3,401.0,ACTUAL,Novo Nordisk A/S,,4.0,,,f,,,,f,t,f,,,t,,,,,https://www.novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,INDUSTRY,,,,,,,2020,1.0
NCT04806529,,2021-03-17,,,2021-03-19,2021-03-17,2021-03-19,ACTUAL,,,,,,,2021-03-19,2021-03-23,ACTUAL,2020-12-15,ESTIMATED,2020-12-15,2021-03,2021-03-31,2022-04-09,ESTIMATED,2022-04-09,2020-12-15,ESTIMATED,2020-12-15,,INTERVENTIONAL,,,"An Efficacy, Immunogenicity and Safety Study Investigating an Adjuvanted SARS-CoV-2 Influenza Vaccine to Protect Against COVID-19 in Adults Over Aged 18 Years-old and Older","A Phase 2/3 Randomised, Observer-blind, Placebo-controlled, Multi-centre Study to Evaluate the Efficacy, Immunogenicity and Safety of the Adjuvanted SARS-CoV-2 Subunit Vaccine in Adults Aged 18 Years and Above",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Seqirus,,2.0,,Seqirus discontinued V451_07 Phase 2 start-up activities prior to enrolling subjects. Data from Phase 1 did not support further development. Further details are here: www.seqirus.com/news/update-on-the-university-of-queensland-covid-19-vaccine,f,,,,t,t,f,,,f,,,SEQIRUS discloses results from clinical studies within 12 months of last patient last visit (LPLV) unless otherwise mandated by local laws or regulations.,"Access: SEQIRUS considers requests from qualified scientific and medical researchers to disclose protocols, anonymized subject-level data and study-level data when there is medical, scientific and/or public health interest to ensure the safe use of a Seqirus product licensed on or after 1 January 2014 in the US and/or EU. This applies to Seqirus-sponsored interventional studies initiated after 27 September 2007 and ongoing as of 26 December 2007, that have been included as part of a US or EU submission package which received approval in US and EU on or after 1 January 2014 and have been accepted for publication",https://www.seqirus.us/partnering,YES,"SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release.~Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry \[EU CTR\])~Supporting Information:~* Study Protocol~* Statistical Analysis Plan (SAP)",2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,INDUSTRY,,,,,,,2022,0.0
NCT04720547,,2021-01-20,2022-03-08,,2023-12-04,2021-01-21,2021-01-22,ACTUAL,2022-04-02,2022-04-28,ACTUAL,,,,2023-12-04,2023-12-06,ACTUAL,2018-07-03,ACTUAL,2018-07-03,2023-12,2023-12-31,2020-02-29,ACTUAL,2020-02-29,2020-02-29,ACTUAL,2020-02-29,,INTERVENTIONAL,,,Sleep and Breathing in the General Population - Chemical Stimuli,"Sleep and Breathing in Health and Disease (Part 2A - Chemical Stimuli, Sleep and Breathing in the General Population)",COMPLETED,,PHASE4,14.0,ACTUAL,Wayne State University,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,OTHER,,,,,,,2020,1.0
NCT06018116,,2023-08-25,,,2024-02-13,2023-08-25,2023-08-30,ACTUAL,,,,,,,2024-02-13,2024-02-15,ACTUAL,2023-11-07,ACTUAL,2023-11-07,2024-02,2024-02-29,2024-02-12,ACTUAL,2024-02-12,2024-01-31,ACTUAL,2024-01-31,,INTERVENTIONAL,CANUCK-01,,A Canadian Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer.,"A Canadian Phase II, Placebo-controlled Randomized Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer.",WITHDRAWN,,PHASE2,0.0,ACTUAL,CHU de Quebec-Universite Laval,,2.0,,Results of EV302 study do not make it feasible to complete a study in second line avelumab immunotherapy. The new standard of care make this study not pertinent.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,OTHER,,,,,,,2024,0.0
NCT02525796,,2015-08-14,2023-03-01,,2023-04-28,2015-08-14,2015-08-17,ESTIMATED,2023-04-28,2023-05-03,ACTUAL,,,,2023-04-28,2023-05-03,ACTUAL,2016-01,ACTUAL,2016-01-31,2023-04,2023-04-30,2021-10-02,ACTUAL,2021-10-02,2021-10-01,ACTUAL,2021-10-01,,INTERVENTIONAL,,Patient with primary hyperparathyroidism,Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism,Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism,COMPLETED,,PHASE2/PHASE3,69.0,ACTUAL,Brigham and Women's Hospital,,3.0,,,f,,,,f,,,,,,,,,,,YES,IPD will be shared with interested investigators upon request 1 year after the study is completed. Investigators may request IPD by contacting the PI and proposing a data analysis plan,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,OTHER,,,,,,,2021,1.0
NCT02832531,,2016-01-07,,,2022-07-14,2016-07-11,2016-07-14,ESTIMATED,,,,,,,2022-07-14,2022-07-19,ACTUAL,2022-01,ESTIMATED,2022-01-31,2022-07,2022-07-31,2022-08,ESTIMATED,2022-08-31,2022-04,ESTIMATED,2022-04-30,,INTERVENTIONAL,INVICTUS-ASA,,"INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Superiority","INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies",WITHDRAWN,,PHASE3,0.0,ACTUAL,Population Health Research Institute,,2.0,,Focus on recruitment for non-inferiority trial,f,,,,t,f,f,,,,,,,,,NO,cumulative participant data only,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,OTHER,,,,,,,2022,0.0
NCT05248867,,2022-02-14,2024-03-11,,2024-04-29,2022-02-14,2022-02-21,ACTUAL,2024-04-29,2024-05-24,ACTUAL,,,,2024-04-29,2024-05-24,ACTUAL,2022-03-16,ACTUAL,2022-03-16,2024-04,2024-04-30,2023-03-17,ACTUAL,2023-03-17,2023-03-17,ACTUAL,2023-03-17,,INTERVENTIONAL,,"Intent to Treat Population: all randomized participants, analyzed according to the treatment groups to which they were randomized",A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines,"A Phase 3, Multicenter Study to Evaluate the Safety and Efficacy of AGN-151586 for the Treatment of Glabellar Lines",COMPLETED,,PHASE3,638.0,ACTUAL,AbbVie,,2.0,,,f,,,,f,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,INDUSTRY,,,,,,,2023,1.0
NCT04396340,,2020-05-15,,,2024-03-14,2020-05-15,2020-05-20,ACTUAL,,,,,,,2024-03-14,2024-03-15,ACTUAL,2020-05-11,ACTUAL,2020-05-11,2024-03,2024-03-31,2022-09-30,ACTUAL,2022-09-30,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,,,First-in-Human Study of XMT-1592 in Patients With Ovarian Cancer and NSCLC Likely to Express NaPi2b,"A Phase 1b, First-in-Human, Dose Escalation and Expansion Study of XMT-1592 In Patients With Solid Tumors Likely to Express NaPi2b",TERMINATED,,PHASE1,31.0,ACTUAL,Mersana Therapeutics,,2.0,,discontinued development program,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,INDUSTRY,,,,,,,2022,0.0
NCT03939364,,2019-04-18,,,2021-10-11,2019-05-03,2019-05-06,ACTUAL,,,,,,,2021-10-11,2021-10-19,ACTUAL,2022-01,ESTIMATED,2022-01-31,2021-10,2021-10-31,2023-05,ESTIMATED,2023-05-31,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,,,This Study is to Evaluate the Safety and Pharmacokinetics of SBS-101 in Patients With Oral Premalignant Lesions,"A Phase 1, Randomized, Double-blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of SBS-101 After Intraoral Application in Patients With Oral Premalignant Lesions (OPL)",WITHDRAWN,,PHASE1,0.0,ACTUAL,Skyline Biosciences,,4.0,,Delays due to manufacturing and the COVID-19 pandemic,f,,,,,t,f,,,,,,,,,,,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,INDUSTRY,,,,,,,2023,0.0
NCT04545385,,2020-08-24,2022-12-15,,2023-03-10,2020-09-03,2020-09-11,ACTUAL,2023-03-10,2023-03-13,ACTUAL,,,,2023-03-10,2023-03-13,ACTUAL,2020-10-07,ACTUAL,2020-10-07,2023-03,2023-03-31,2022-01-17,ACTUAL,2022-01-17,2022-01-17,ACTUAL,2022-01-17,,INTERVENTIONAL,,The intent-to-treat (ITT) analysis set included all randomized participants.,A Study to Test if TEV-48574 is Effective in Relieving Asthma,"A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Evaluate the Efficacy and Safety of TEV-48574 in Adults With T2-low/Non-T2 Severe Uncontrolled Asthma",TERMINATED,,PHASE2,65.0,ACTUAL,"Teva Branded Pharmaceutical Products R&D, Inc.",,2.0,,Met pre-specified criteria for futility at interim analysis,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.)",2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,INDUSTRY,,,,,,,2022,0.0
NCT04169698,,2019-11-18,,,2021-11-11,2019-11-18,2019-11-20,ACTUAL,,,,,,,2021-11-11,2021-11-12,ACTUAL,2019-10-17,ACTUAL,2019-10-17,2021-11,2021-11-30,2021-05-01,ACTUAL,2021-05-01,2021-05-01,ACTUAL,2021-05-01,,INTERVENTIONAL,,,Alendronate Versus Denosumab in Kidney Transplant Patients,Evaluation of the Efficacy and Tolerability of Alendronate Versus Denosumab in Kidney Transplant Patients With Reduced Bone Mineral Density,COMPLETED,,PHASE2/PHASE3,90.0,ACTUAL,Ain Shams University,,3.0,,,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,OTHER,,,,,,,2021,1.0
NCT03605589,,2018-07-20,,,2021-03-30,2018-07-27,2018-07-30,ACTUAL,,,,,,,2021-03-30,2021-04-01,ACTUAL,2018-09-27,ACTUAL,2018-09-27,2021-03,2021-03-31,2022-01,ESTIMATED,2022-01-31,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,,,Pembro + Blina Combination in Pediatric and Young Adult Patients With Relapsed/Refractory Acute Leukemia or Lymphoma,"A Pilot Study of Blinatumomab in Combination With a PD1 Inhibitor, Pembrolizumab, in Pediatric and Young Adult Patients With Relapsed/Refractory CD19 Positive B-cell Acute Leukemia or Lymphoma",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Children's Hospital Medical Center, Cincinnati",,1.0,,Lack of enrollment due to the availability of other novel salvage therapies for relapsed/refractory B-ALL.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,OTHER,,,,,,,2022,0.0
NCT03137537,,2017-04-19,2022-01-19,,2022-01-19,2017-04-28,2017-05-02,ACTUAL,2022-01-19,2022-02-10,ACTUAL,,,,2022-01-19,2022-02-10,ACTUAL,2018-02-27,ACTUAL,2018-02-27,2022-01,2022-01-31,2020-11-18,ACTUAL,2020-11-18,2020-11-18,ACTUAL,2020-11-18,,INTERVENTIONAL,,,Ivabradine in the Management of Cardiac Autonomic Dysfunction Associated With Thoracic Radiation Therapy.,Ivabradine in the Management of Cardiac Autonomic Dysfunction Associated With Thoracic Radiation Therapy.,TERMINATED,,PHASE2,23.0,ACTUAL,Dana-Farber Cancer Institute,,2.0,,Funding terminated,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,OTHER,,,,,,,2020,0.0
NCT04272645,,2020-02-13,,,2020-07-13,2020-02-13,2020-02-17,ACTUAL,,,,,,,2020-07-13,2020-07-15,ACTUAL,2020-10,ESTIMATED,2020-10-31,2020-07,2020-07-31,2022-10,ESTIMATED,2022-10-31,2022-10,ESTIMATED,2022-10-31,,INTERVENTIONAL,,,Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer,A Phase II Multi-Center Trial of Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Michigan Rogel Cancer Center,,3.0,,Coordinating site change,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,OTHER,,,,,,,2022,0.0
NCT05603143,,2022-10-31,,,2023-11-22,2022-10-31,2022-11-02,ACTUAL,,,,,,,2023-11-22,2023-11-28,ACTUAL,2022-11-05,ACTUAL,2022-11-05,2023-11,2023-11-30,2023-11-07,ACTUAL,2023-11-07,2023-11-07,ACTUAL,2023-11-07,,INTERVENTIONAL,BIRCH,,Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Participants With High-Risk for Disease Progression",TERMINATED,,PHASE3,468.0,ACTUAL,Gilead Sciences,,2.0,,The study was stopped early as it was determined there would not be a statistically significant treatment effect associated with the primary endpoint due to the low number of events.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,INDUSTRY,,,,,,,2023,0.0
NCT03582085,,2018-06-18,,,2022-04-05,2018-06-27,2018-07-10,ACTUAL,,,,,,,2022-04-05,2022-04-06,ACTUAL,2022-01-01,ESTIMATED,2022-01-01,2022-04,2022-04-30,2023-01-01,ESTIMATED,2023-01-01,2023-01-01,ESTIMATED,2023-01-01,,INTERVENTIONAL,,,Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia,Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia,WITHDRAWN,,PHASE2,0.0,ACTUAL,Massachusetts General Hospital,,2.0,,No funding at the current time.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,OTHER,,,,,,,2023,0.0
NCT05051449,,2021-09-10,,,2024-03-05,2021-09-10,2021-09-21,ACTUAL,,,,,,,2024-03-05,2024-03-07,ACTUAL,2022-04-04,ACTUAL,2022-04-04,2024-03,2024-03-31,2023-11-30,ACTUAL,2023-11-30,2023-11-17,ACTUAL,2023-11-17,,INTERVENTIONAL,,,Ketamine for OUD and Comorbid Depression (OUDCD),Increasing Retention in Methadone Maintenance Treatment: Feasibility and Preliminary Efficacy of Ketamine for the Treatment of Patients With OUD and Comorbid Depression (OUDCD),TERMINATED,,PHASE1,5.0,ACTUAL,"University of Maryland, Baltimore",,1.0,,Study funds were exhausted,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,OTHER,,,,,,,2023,0.0
NCT04236453,,2020-01-21,,,2020-07-03,2020-01-21,2020-01-22,ACTUAL,,,,,,,2020-07-03,2020-07-07,ACTUAL,2020-01-23,ACTUAL,2020-01-23,2020-07,2020-07-31,2020-04-10,ACTUAL,2020-04-10,2020-04-10,ACTUAL,2020-04-10,,INTERVENTIONAL,,,"A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents","A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Subjects to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Conditions",TERMINATED,,PHASE1,16.0,ACTUAL,"Janssen Pharmaceutica N.V., Belgium",,2.0,,COVID-19 pandemic impacted the BE assessment of the trial. The clinical team decided to terminate the trial in order to start a new pivotal BE trial,f,,,,f,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 06:27:05.049356,2024-10-16 06:27:05.049356,INDUSTRY,,,,,,,2020,0.0
NCT02846831,,2016-07-25,,,2020-06-08,2016-07-25,2016-07-27,ESTIMATED,,,,,,,2020-06-08,2020-06-11,ACTUAL,2019-01-24,ACTUAL,2019-01-24,2020-06,2020-06-30,2020-01-27,ACTUAL,2020-01-27,2020-01-27,ACTUAL,2020-01-27,,INTERVENTIONAL,,,Closed-loop Control of Glucose Levels (Artificial Pancreas) for 12 Days in Adults With Type 1 Diabetes,"An Open-label, Randomized, Two-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy and Sensor-augmented Pump Therapy in Regulating Glucose Levels for 12 Days in Free-living Outpatient Conditions in Patients With Type 1 Diabetes",COMPLETED,,PHASE2,36.0,ACTUAL,Institut de Recherches Cliniques de Montreal,,2.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,OTHER,,,,,,,2020,1.0
NCT03837860,,2019-02-05,,,2022-01-31,2019-02-08,2019-02-12,ACTUAL,,,,,,,2022-01-31,2022-02-15,ACTUAL,2019-04-01,ACTUAL,2019-04-01,2022-01,2022-01-31,2022-01-21,ACTUAL,2022-01-21,2021-03-23,ACTUAL,2021-03-23,,INTERVENTIONAL,,,Reducing the Abuse of Opioids in Drug Users,Reducing the Abuse Liability of Prescription Opioids in Recreational Drug Users: A Pilot Study,TERMINATED,,EARLY_PHASE1,3.0,ACTUAL,The University of Texas Health Science Center at San Antonio,,3.0,,PI leaving institution,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,OTHER,,,,,,,2022,0.0
NCT03312855,,2017-10-13,,,2020-04-17,2017-10-13,2017-10-18,ACTUAL,,,,,,,2020-04-17,2020-04-20,ACTUAL,2017-11-20,ACTUAL,2017-11-20,2020-04,2020-04-30,2020-03-26,ACTUAL,2020-03-26,2020-02-29,ACTUAL,2020-02-29,,INTERVENTIONAL,ISAR-PLASTER,,Intracoronary Stenting and Antithrombotic Regimen: Lesion Platelet Adhesion as Selective Target of Endovenous Revacept,"Revacept, a Novel Inhibitor of Platelet Adhesion in Patients With Stable Coronary Artery Disease Undergoing Elective Percutaneous Coronary Interventions: a Phase II, Multicentre, Randomised, Double-blind and Placebo-controlled Study",COMPLETED,,PHASE2,334.0,ACTUAL,Deutsches Herzzentrum Muenchen,,3.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 06:27:05.049356,2024-10-16 06:27:05.049356,OTHER,,,,,,,2020,0.0
NCT03068780,,2017-02-27,2023-04-07,,2023-07-03,2017-02-27,2017-03-03,ACTUAL,2023-06-12,2023-07-03,ACTUAL,,,,2023-07-03,2023-07-20,ACTUAL,2017-03-29,ACTUAL,2017-03-29,2023-07,2023-07-31,2022-05-27,ACTUAL,2022-05-27,2020-06-11,ACTUAL,2020-06-11,,INTERVENTIONAL,EASE,,Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa,"Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study With 24-month Open-label Follow-up of Oleogel-S10 in Patients With Inherited Epidermolysis Bullosa",COMPLETED,,PHASE3,223.0,ACTUAL,Amryt Pharma,,2.0,,,t,,,,t,t,f,,,,,,,,,NO,,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,INDUSTRY,,,,,,,2022,1.0
NCT03002506,,2016-12-21,2020-10-19,,2021-03-01,2016-12-21,2016-12-23,ESTIMATED,2021-03-01,2021-03-02,ACTUAL,,,,2021-03-01,2021-03-02,ACTUAL,2017-08-21,ACTUAL,2017-08-21,2021-03,2021-03-31,2020-06-30,ACTUAL,2020-06-30,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,,All participants who provided informed consent and received ceftolozane/tazobactam.,Pharmacokinetics of Ceftolozane/Tazobactam in Patients With Burns,Pharmacokinetics of Ceftolozane/Tazobactam in Patients With Burns,TERMINATED,,PHASE4,6.0,ACTUAL,Texas Tech University Health Sciences Center,Single-dose pharmacokinetic study. No clinical outcomes to evaluate efficacy. No safety data provided by this study beyond a single dose in this population.,1.0,,Much slower recruitment than anticipated,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 06:27:05.049356,2024-10-16 06:27:05.049356,OTHER,,,,,,,2020,0.0
NCT03979664,,2019-06-05,,,2021-03-29,2019-06-06,2019-06-07,ACTUAL,,,,,,,2021-03-29,2021-04-01,ACTUAL,2021-03,ESTIMATED,2021-03-31,2021-03,2021-03-31,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Iontophoresis in Psoriasis,Efficacy of Dexamethasone Iontophoresis in Psoriasis,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,FDA did not provide approval of the use of the drug for the study,f,,,,f,t,t,,,f,,,,,,NO,,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,OTHER,,,,,,,2021,0.0
NCT02911714,,2016-09-19,,,2024-06-18,2016-09-19,2016-09-22,ESTIMATED,,,,,,,2024-06-18,2024-06-21,ACTUAL,2018-02-21,ACTUAL,2018-02-21,2024-06,2024-06-30,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,,Contrast-Enhanced Ultrasound for Kidney Transplant,A Pilot Study to Develop Contrast-Enhanced Ultrasound for Kidney Transplant,TERMINATED,,PHASE1,20.0,ACTUAL,University of Utah,,2.0,,lack of funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,OTHER,,,,,,,2022,0.0
NCT02838030,,2016-05-26,,,2020-11-25,2016-07-15,2016-07-20,ESTIMATED,,,,,,,2020-11-25,2020-11-27,ACTUAL,2018-07-01,ACTUAL,2018-07-01,2020-11,2020-11-30,2021-08,ESTIMATED,2021-08-31,2021-07,ESTIMATED,2021-07-31,,INTERVENTIONAL,,,Efficacy of Aspirin and L-arginine in High Risk Preeclamptic,Efficacy of the Combination of Acetylsalicylic Acid and L-arginine to Prevent Preeclampsia in Pregnant High Risk,SUSPENDED,,PHASE2,82.0,ESTIMATED,University of Guadalajara,,2.0,,COVID-19 pandemic,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 06:27:05.049356,2024-10-16 06:27:05.049356,OTHER,,,,,,,2021,0.0
NCT03916068,,2019-04-04,,,2023-10-02,2019-04-12,2019-04-16,ACTUAL,,,,,,,2023-10-02,2023-10-04,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2023-10,2023-10-31,2023-10-02,ACTUAL,2023-10-02,2023-10-02,ACTUAL,2023-10-02,,INTERVENTIONAL,,,Acute Post-Radiation Hyperbaric Oxygen (HBO2) for Breast Cancer Patients Who Have Recently Completed Radiation Therapy,A Pilot Study Comparing Acute Post-Radiation Hyperbaric Oxygen (HBO2) Versus Trental and Vitamin E for Breast Cancer Patients Who Have Recently Completed Radiation Therapy as Part of Their Treatment Course,TERMINATED,,PHASE2,1.0,ACTUAL,Legacy Health System,,2.0,,Insufficient enrollment,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 06:27:05.049356,2024-10-16 06:27:05.049356,OTHER,,,,,,,2023,0.0
NCT04341610,,2020-04-07,,,2020-05-25,2020-04-09,2020-04-10,ACTUAL,,,,,,,2020-05-25,2020-05-27,ACTUAL,2020-04-20,ESTIMATED,2020-04-20,2020-05,2020-05-31,2021-04-30,ESTIMATED,2021-04-30,2021-01-30,ESTIMATED,2021-01-30,,INTERVENTIONAL,ASC COVID-19,,ASC Therapy for Patients With Severe Respiratory COVID-19,"Allogeneic Adipose Tissue Derived Mesenchymal Stromal Cell Therapy for Treating Patients With Severe Respiratory COVID-19. A Danish, Double-blind, Randomized Placebo-controlled Study",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Rigshospitalet, Denmark",,2.0,,Not approved by ethical committee,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 06:27:05.049356,2024-10-16 06:27:05.049356,OTHER,,,,,,,2021,0.0
NCT02977689,,2016-11-28,,,2017-12-18,2016-11-29,2016-11-30,ESTIMATED,,,,,,,2017-12-18,2017-12-20,ACTUAL,2018-04,ESTIMATED,2018-04-30,2017-12,2017-12-31,2020-04,ESTIMATED,2020-04-30,2020-04,ESTIMATED,2020-04-30,,INTERVENTIONAL,,,Trial of IDH305 in IDH1 Mutant Grade II or III Glioma,Phase 2 Study of IDH305 in Subjects With IDH1 Mutant Grade II or III Glioma That Has Progressed After Observation or Radiation Therapy,WITHDRAWN,,PHASE2,0.0,ACTUAL,NYU Langone Health,,1.0,,Novartis paused all study start-up activities due to safety evaluation of IDH305 compound.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,OTHER,,,,,,,2020,0.0
NCT00630032,,2008-03-05,2021-02-22,,2024-02-20,2008-03-05,2008-03-06,ESTIMATED,2021-02-22,2021-03-16,ACTUAL,,,,2024-02-20,2024-02-21,ACTUAL,2007-09,ACTUAL,2007-09-30,2024-02,2024-02-29,2020-09-03,ACTUAL,2020-09-03,2017-06,ACTUAL,2017-06-30,,INTERVENTIONAL,TavIx,,Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer,"Randomized, Open Label, Multicentric Phase III Evaluating the Benefit of a Sequential Regimen Associating FEC 100 and Ixabepilone in Adjuvant Treatment of Non Metastatic, Poor Prognosis Breast Cancer Defined as Triple-negative Tumor [HER2 Negative - ER Negative - PR Negative] or [HER2 Negative and PR Negative] Tumor; in Node Positive or Node Negative Patients.",COMPLETED,,PHASE3,762.0,ACTUAL,UNICANCER,,2.0,,,f,,,,t,,,,,,,,"Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.","The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.",,YES,"Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.",2024-10-16 06:27:05.049356,2024-10-16 06:27:05.049356,OTHER,,,,,,,2020,1.0
NCT03190239,,2017-05-12,,,2024-02-26,2017-06-15,2017-06-16,ACTUAL,,,,,,,2024-02-26,2024-02-28,ACTUAL,2017-07-15,ESTIMATED,2017-07-15,2024-02,2024-02-29,2020-07-30,ESTIMATED,2020-07-30,2020-07-30,ESTIMATED,2020-07-30,,INTERVENTIONAL,XQonc-007,,Efficacy and Safety of Maintenance Apatinib Combined With Pemetrexed in Advanced Non-squamous Non-small Cell Lung Cancer Patients,"Efficacy and Safety of Maintenance Apatinib Combined With Pemetrexed After First - Line Induction Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer: A Prospective, Open, Single Arm Clinical Study",WITHDRAWN,,PHASE2,0.0,ACTUAL,Xinqiao Hospital of Chongqing,,1.0,,abandon,f,,,,,f,f,,,,,,,,,,,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,OTHER,,,,,,,2020,0.0
NCT03740009,,2018-11-09,2022-03-14,,2022-04-19,2018-11-09,2018-11-14,ACTUAL,2022-04-19,2022-05-10,ACTUAL,,,,2022-04-19,2022-05-10,ACTUAL,2019-01-02,ACTUAL,2019-01-02,2022-03,2022-03-31,2021-05-17,ACTUAL,2021-05-17,2021-05-17,ACTUAL,2021-05-17,,INTERVENTIONAL,Duavee,,Effects of a Tissue Selective Estrogen Complex (TSEC) on Depression and the Neural Reward System in the Perimenopause,Effects of a Tissue Selective Estrogen Complex (TESC) on Depression and the Neural Reward System in the Perimenopause,COMPLETED,,PHASE4,20.0,ACTUAL,"University of North Carolina, Chapel Hill",,1.0,,,f,,,,,t,f,,,t,,,,,,NO,,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,OTHER,,,,,,,2021,1.0
NCT01875250,,2013-06-07,2020-08-13,,2020-09-14,2013-06-07,2013-06-11,ESTIMATED,2020-09-14,2020-09-16,ACTUAL,,,,2020-09-14,2020-09-16,ACTUAL,2013-07-22,ACTUAL,2013-07-22,2020-09,2020-09-30,2020-02-28,ACTUAL,2020-02-28,2019-09-01,ACTUAL,2019-09-01,,INTERVENTIONAL,,,Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer,A Phase II Trial of Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer,COMPLETED,,PHASE2,38.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,NIH,,,,,,,2020,1.0
NCT03701074,,2018-08-22,2021-04-18,,2021-04-18,2018-10-05,2018-10-09,ACTUAL,2021-04-18,2021-05-11,ACTUAL,,,,2021-04-18,2021-05-11,ACTUAL,2018-12-15,ACTUAL,2018-12-15,2021-04,2021-04-30,2020-12-02,ACTUAL,2020-12-02,2020-10-30,ACTUAL,2020-10-30,,INTERVENTIONAL,,"Overall only one infant was enrolled into the study. Hence, control arm had no patient enrolled",Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus,"Single Center, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus",TERMINATED,,PHASE2,1.0,ACTUAL,University of South Alabama,,2.0,,very slow enrollment. Only one patient enrolled. Termination by PI,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,OTHER,,,,,,,2020,0.0
NCT04478266,,2020-07-10,2023-06-13,,2023-11-15,2020-07-15,2020-07-20,ACTUAL,2023-06-13,2023-07-06,ACTUAL,,,,2023-11-15,2023-12-08,ACTUAL,2020-10-14,ACTUAL,2020-10-14,2023-11,2023-11-30,2023-05-26,ACTUAL,2023-05-26,2022-06-28,ACTUAL,2022-06-28,,INTERVENTIONAL,AMEERA-5,"Analysis was performed on safety population which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention, analyzed according to the treatment arm they actually received.",Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer,"A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease",TERMINATED,,PHASE3,1068.0,ACTUAL,Sanofi,The study was terminated based on the review by an independent data monitoring committee of the prespecified interim analysis of the Phase 3 AMEERA-5 efficacy data.,2.0,,The study was terminated based on the review by an independent data monitoring committee of the prespecified interim analysis of the Phase 3 AMEERA-5 efficacy data. No new safety signals were observed.,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,INDUSTRY,,,,,,,2023,0.0
NCT02758626,,2016-04-04,2022-02-23,,2023-01-23,2016-04-28,2016-05-02,ESTIMATED,2023-01-23,2023-02-16,ACTUAL,,,,2023-01-23,2023-02-16,ACTUAL,2016-11,,2016-11-30,2023-01,2023-01-31,2021-02-27,ACTUAL,2021-02-27,2021-02-27,ACTUAL,2021-02-27,,INTERVENTIONAL,,,Ataluren for Nonsense Mutation in CDKL5 and Dravet Syndrome,"A Phase 2 Randomized, Double-Masked Placebo-Controlled Crossover Safety and Tolerability Study of Ataluren for Drug Resistant Epilepsy in Patients With Nonsense Mutation CDKL5 or Dravet Syndrome",COMPLETED,,PHASE2,15.0,ACTUAL,NYU Langone Health,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,OTHER,,,,,,,2021,0.0
NCT03649711,,2018-08-21,2022-08-26,,2022-12-08,2018-08-21,2018-08-28,ACTUAL,2022-12-08,2022-12-29,ACTUAL,,,,2022-12-08,2022-12-29,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2022-08,2022-08-31,2021-09-02,ACTUAL,2021-09-02,2021-09-02,ACTUAL,2021-09-02,,INTERVENTIONAL,,,Chronic Kidney Disease (CKD) Platelet Study,A Mechanistic Study in Patients With Non-Dialysis Chronic Kidney Disease to Investigate Altered Platelet Response to Antiplatelet Therapy (CKD-Platelet Study),COMPLETED,,PHASE3,76.0,ACTUAL,University of Arkansas,,3.0,,,f,,,,f,t,f,,,f,,,2 years after study closure indefinitely,,,YES,De-identified data for all primary and secondary outcome measures will be uploaded on clinicaltrials.gov website.,2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,OTHER,,,,,,,2021,1.0
NCT03050814,,2017-02-10,2021-11-09,,2021-12-10,2017-02-10,2017-02-13,ACTUAL,2021-11-09,2021-12-09,ACTUAL,,,,2021-12-10,2021-12-20,ACTUAL,2017-04-05,ACTUAL,2017-04-05,2021-12,2021-12-31,2021-08-25,ACTUAL,2021-08-25,2021-08-25,ACTUAL,2021-08-25,,INTERVENTIONAL,,4 participants that were enrolled but not assigned to a treatment arm had baseline data collected and it is reported in this table. These participants were screen failures who were not treated.,Standard of Care Alone or in Combination With Ad-CEA Vaccine and Avelumab in People With Previously Untreated Metastatic Colorectal Cancer QUILT-2.004,A Randomized Phase II Trial of Standard of Care Alone or in Combination With Ad-CEA Vaccine and Avelumab in Patients With Previously Untreated Metastatic or Unresectable Colorectal Cancer,TERMINATED,,PHASE2,30.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,Terminated after an unplanned interim efficacy analysis.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,NIH,,,,,,,2021,0.0
NCT04515394,,2020-08-11,2022-09-12,,2022-11-30,2020-08-13,2020-08-17,ACTUAL,2022-11-30,2022-12-22,ACTUAL,,,,2022-11-30,2022-12-22,ACTUAL,2021-01-28,ACTUAL,2021-01-28,2022-11,2022-11-30,2022-03-31,ACTUAL,2022-03-31,2022-03-14,ACTUAL,2022-03-14,,INTERVENTIONAL,,,Study of Tepotinib Combined With Cetuximab in Participants With Left-Sided RAS/BRAF Wild Type Metastatic Colorectal Cancer (PERSPECTIVE),A Phase II Single-Arm Study to Investigate Tepotinib Combined With Cetuximab in RAS/BRAF Wild-Type Left-Sided mCRC Patients Having Acquired Resistance to Anti-EGFR Antibody Targeting Therapy Due to MET Amplification (PERSPECTIVE),TERMINATED,,PHASE2,3.0,ACTUAL,EMD Serono,,1.0,,The study was terminated early due to operational challenges identifying suitable participants for screening in the study.,f,,,,f,t,f,,,,,,Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union,Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.,http://bit.ly/IPD21,YES,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21",2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,INDUSTRY,,,,,,,2022,0.0
NCT04363866,,2020-04-24,,,2020-10-27,2020-04-24,2020-04-27,ACTUAL,,,,,,,2020-10-27,2020-10-29,ACTUAL,2020-08,ESTIMATED,2020-08-31,2020-10,2020-10-31,2021-09,ESTIMATED,2021-09-30,2021-03,ESTIMATED,2021-03-31,,INTERVENTIONAL,,,Assessing Hydroxychloroquine in Patients With SARS-CoV-2 (COVID-19),A Randomized-Control Pilot Study to Assess Hydroxychloroquine in Patients Infected With SARS-CoV-2 (COVID-19),WITHDRAWN,,PHASE2,0.0,ACTUAL,Oregon Health and Science University,,2.0,,discontinued in favor of more promising directions that may benefit patients,f,,,,t,t,f,,,f,,,Beginning 3 months and ending 5 years following article publication,Anyone who wishes to access the data for any purpose. Data may be obtained by contacting the corresponding author of the relevant publication,,YES,"Individual participant data that underlie the results reported in this article, after the identification",2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,OTHER,,,,,,,2021,0.0
NCT03977155,,2019-06-05,2021-05-05,,2021-06-03,2019-06-05,2019-06-06,ACTUAL,2021-06-03,2021-06-07,ACTUAL,,,,2021-06-03,2021-06-07,ACTUAL,2019-06-04,ACTUAL,2019-06-04,2021-06,2021-06-30,2020-05-06,ACTUAL,2020-05-06,2020-05-06,ACTUAL,2020-05-06,,INTERVENTIONAL,,,"Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)","A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)",COMPLETED,,PHASE2,133.0,ACTUAL,Boston Pharmaceuticals,,3.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,INDUSTRY,,,,,,,2020,1.0
NCT04561817,,2020-09-08,,,2020-10-02,2020-09-22,2020-09-24,ACTUAL,,,,,,,2020-10-02,2020-10-06,ACTUAL,2020-10-01,ESTIMATED,2020-10-01,2020-10,2020-10-31,2023-10-01,ESTIMATED,2023-10-01,2022-10-01,ESTIMATED,2022-10-01,,INTERVENTIONAL,,,To Evaluate the Safety and Efficacy of Ipatasertib (GDC-0068) in Combination With Paclitaxel in Platinum-resistant Recurrent Epithelial Ovarian Cancer,An Open Label Phase II Study to Evaluate the Safety and Efficacy of Ipatasertib (GDC-0068) in Combination With Paclitaxel in Platinum-resistant Recurrent Epithelial Ovarian Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,2.0,,Evolving data with Ipatasertib that changes the known risk / benefit background in pursuing future studies.,f,,,,t,t,f,,,,,,Beginning 3 months and ending 5 years following article publication.,Investigators whose proposed use of the data has been approved by an independent review committee (%8Dlearned intermediary%8E) identified for this purpose.To achieve aims in the approved proposal.information on Availability of data will be provided later,,YES,"All of the individual participant data collected during the trial, after deidentification.",2024-10-16 07:11:01.772078,2024-10-16 07:11:01.772078,OTHER,,,,,,,2023,0.0
NCT03877549,,2019-03-14,,,2023-09-22,2019-03-14,2019-03-15,ACTUAL,,,,,,,2023-09-22,2023-09-26,ACTUAL,2019-05-24,ACTUAL,2019-05-24,2023-09,2023-09-30,2022-06-15,ACTUAL,2022-06-15,2022-06-15,ACTUAL,2022-06-15,,INTERVENTIONAL,,,Dexamethasone Administered Via the Epidural Catheter as an Adjunct in Patients Undergoing Cesarean Delivery,Dexamethasone Administered Via the Epidural Catheter as an Adjunct in Patients Undergoing Cesarean Delivery,WITHDRAWN,,PHASE4,0.0,ACTUAL,Henry Ford Health System,,3.0,,PI left Henry Ford Health before completion.,f,,,,,t,f,,,t,,,,,,,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,OTHER,,,,,,,2022,0.0
NCT01889238,,2013-06-26,2018-07-26,2016-03-21,2024-02-07,2013-06-26,2013-06-28,ESTIMATED,2018-07-26,2018-08-22,ACTUAL,2016-03-21,2016-04-22,ESTIMATED,2024-02-07,2024-02-12,ACTUAL,2013-06-12,ACTUAL,2013-06-12,2024-02,2024-02-29,2024-01-10,ACTUAL,2024-01-10,2015-03-01,ACTUAL,2015-03-01,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all enrolled participants who had positive androgen receptor (AR+) breast cancer as assessed by central review and received at least 1 dose of study drug.,"Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer","A PHASE 2, SINGLE-ARM, OPEN-LABEL, MULTICENTER STUDY OF THE CLINICAL ACTIVITY AND SAFETY OF ENZALUTAMIDE IN PATIENTS WITH ADVANCED, ANDROGEN RECEPTOR-POSITIVE, TRIPLE-NEGATIVE BREAST CANCER",COMPLETED,,PHASE2,118.0,ACTUAL,Pfizer,"As per change in planned analysis, AR low population (all enrolled participants who had AR nuclear staining \> 0%, \< 10% assessed centrally) was not analyzed for efficacy and duration of response, time to response were not analyzed for any population",1.0,,,f,,,,,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,INDUSTRY,,,,,,,2024,1.0
NCT05199142,,2021-11-30,,,2022-04-14,2022-01-14,2022-01-20,ACTUAL,,,,,,,2022-04-14,2022-04-22,ACTUAL,2021-09-23,ACTUAL,2021-09-23,2022-04,2022-04-30,2022-03-11,ACTUAL,2022-03-11,2022-03-11,ACTUAL,2022-03-11,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline","A Phase 1b, Exploratory, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline",TERMINATED,,PHASE1,5.0,ACTUAL,Syndesi Therapeutics,,2.0,,Development plan changed,f,,,,f,f,f,,,,,,,,,,,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,INDUSTRY,,,,,,,2022,0.0
NCT04252586,,2020-01-30,2022-06-06,,2022-07-12,2020-01-30,2020-02-05,ACTUAL,2022-07-12,2022-08-08,ACTUAL,,,,2022-07-12,2022-08-08,ACTUAL,2020-02-28,ACTUAL,2020-02-28,2022-07,2022-07-31,2021-06-09,ACTUAL,2021-06-09,2021-06-09,ACTUAL,2021-06-09,,INTERVENTIONAL,,Baseline characteristics were assessed in the Safety Analysis Set which was defined as all participants who received at least one dose of GWP42003-P in the study.,"A Long-term Safety Study of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome","An Open-label Extension Trial to Investigate the Long-term Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome",TERMINATED,,PHASE3,21.0,ACTUAL,Jazz Pharmaceuticals,"This trial was terminated due to enrollment challenges and the COVID-19 pandemic. Due to early termination and participants withdrawal, the number of participants was small and the length of treatment was reduced.",1.0,,Study was terminated due to COVID-19 pandemic and recruitment challenges in the parent study (GWND18064 - NCT03848832).,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,INDUSTRY,,,,,,,2021,0.0
NCT03878953,,2019-03-15,,,2022-10-06,2019-03-15,2019-03-18,ACTUAL,,,,,,,2022-10-06,2022-10-10,ACTUAL,2022-08-31,ESTIMATED,2022-08-31,2022-10,2022-10-31,2023-05-31,ESTIMATED,2023-05-31,2023-05-31,ESTIMATED,2023-05-31,,INTERVENTIONAL,,,A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism,"A Phase 3, Open-label Clinical Study of rhPTH(1-84) Treatment in Japanese Subjects With Chronic Hypoparathyroidism",WITHDRAWN,,PHASE3,0.0,ACTUAL,Takeda,,1.0,,Business decision,f,,,,f,t,f,,,t,,,,,,NO,De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be reidentified (due to the limited number of study participants/study sites).,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,INDUSTRY,,,,,,,2023,0.0
NCT05344365,,2022-04-18,,,2024-03-19,2022-04-18,2022-04-25,ACTUAL,,,,,,,2024-03-19,2024-03-21,ACTUAL,2022-06,ESTIMATED,2022-06-30,2024-03,2024-03-31,2023-11,ESTIMATED,2023-11-30,2023-11,ESTIMATED,2023-11-30,,INTERVENTIONAL,,,A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis,"An Open-label, Sequential Cohorts, Flexible Dose Study to Evaluate the Tolerability, Safety and Pharmacokinetics of Iloperidone in Elderly Patients With Parkinson's Disease Psychosis (PDP)",WITHDRAWN,,PHASE2,0.0,ACTUAL,Vanda Pharmaceuticals,,2.0,,Study was terminated for business reasons; not due to safety or efficacy concerns.,f,,,,,t,f,,,,,,,,,,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,INDUSTRY,,,,,,,2023,0.0
NCT04362254,,2020-04-23,,,2023-02-08,2020-04-23,2020-04-24,ACTUAL,,,,,,,2023-02-08,2023-02-10,ACTUAL,2020-05-15,ACTUAL,2020-05-15,2023-02,2023-02-28,2022-09-23,ACTUAL,2022-09-23,2022-05-14,ACTUAL,2022-05-14,,INTERVENTIONAL,,,A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials,"An Open Label, Long Term Safety Trial of Spesolimab Treatment in Patients With Crohn's Disease Who Have Completed Previous Spesolimab Trials",TERMINATED,,PHASE2,12.0,ACTUAL,Boehringer Ingelheim,,1.0,,BI's decision to terminate the development of spesolimab in fistulising and fibrostenotic Crohn's disease.,f,,,,t,f,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,INDUSTRY,,,,,,,2022,0.0
NCT04333355,,2020-03-31,,,2021-02-08,2020-04-01,2020-04-03,ACTUAL,,,,,,,2021-02-08,2021-02-10,ACTUAL,2020-05-08,ACTUAL,2020-05-08,2021-02,2021-02-28,2020-08-20,ACTUAL,2020-08-20,2020-08-20,ACTUAL,2020-08-20,,INTERVENTIONAL,,,Safety in Convalescent Plasma Transfusion to COVID-19,Phase 1 Study to Evaluate the Safety of Convalescent Plasma as an Adjuvant Therapy in Patients With SARS-CoV-2 Infection,TERMINATED,,PHASE1,12.0,ACTUAL,Hospital San Jose Tec de Monterrey,,1.0,,Other clinical trails probed that the use of convalescent plasma for patients with COVID-19 is safe .,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,OTHER,,,,,,,2020,0.0
NCT04184882,,2019-12-02,,,2023-10-17,2019-12-02,2019-12-04,ACTUAL,,,,,,,2023-10-17,2023-10-18,ACTUAL,2021-02-24,ACTUAL,2021-02-24,2023-10,2023-10-31,2022-09-04,ACTUAL,2022-09-04,2022-09-04,ACTUAL,2022-09-04,,INTERVENTIONAL,,,"A Study to Assess the Safety, Tolerability and Preliminary Efficacy of ASP0367 (MA-0211) in Pediatric Male Participants With Duchenne Muscular Dystrophy (DMD)","A Randomized, Double Blind, Placebo-Controlled Phase 1b Study With Open-Label Extension to Assess the Safety, Tolerability and Preliminary Efficacy of ASP0367 (MA-0211) in Pediatric Male Patients With Duchenne Muscular Dystrophy (DMD)",TERMINATED,,PHASE1,8.0,ACTUAL,Astellas Pharma Inc,,2.0,,Operational Reasons,f,,,,t,t,f,,,,,,,,,NO,Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,INDUSTRY,,,,,,,2022,0.0
NCT04162899,,2019-10-15,2022-06-28,,2022-06-28,2019-11-11,2019-11-14,ACTUAL,2022-06-28,2023-05-09,ACTUAL,,,,2022-06-28,2023-05-09,ACTUAL,2019-11-06,ACTUAL,2019-11-06,2022-06,2022-06-30,2020-08-31,ACTUAL,2020-08-31,2020-08-21,ACTUAL,2020-08-21,,INTERVENTIONAL,,,A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis,"A Randomized, Double-Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Moderate to Severe Atopic Dermatitis",COMPLETED,,PHASE2,105.0,ACTUAL,Reistone Biopharma Company Limited,,3.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,INDUSTRY,,,,,,,2020,1.0
NCT04435782,,2020-06-15,2024-07-24,,2024-07-24,2020-06-15,2020-06-17,ACTUAL,2024-07-24,2024-08-20,ACTUAL,,,,2024-07-24,2024-08-20,ACTUAL,2021-07-07,ACTUAL,2021-07-07,2024-06,2024-06-30,2023-07-28,ACTUAL,2023-07-28,2023-07-28,ACTUAL,2023-07-28,,INTERVENTIONAL,RESTORE,,A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging,"A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging",TERMINATED,,PHASE4,9.0,ACTUAL,Actelion,,1.0,,The Sponsor decided to prematurely terminate the study due to the lower-than-expected recruitment rate.,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.",2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,INDUSTRY,,,,,,,2023,0.0
NCT02866916,,2016-08-08,,,2021-01-15,2016-08-10,2016-08-15,ESTIMATED,,,,,,,2021-01-15,2021-01-20,ACTUAL,2017-09,ESTIMATED,2017-09-30,2016-11,2016-11-30,2020-06,ESTIMATED,2020-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,PROSTIRNA,,Study of SXL01 in Patients With Metastatic Castration-Resistant Prostate Cancer (PROSTIRNA),Phase I Study of SXL01 in Patients With Metastatic Castration-Resistant Prostate Cancer,WITHDRAWN,,PHASE1,0.0,ACTUAL,Institut Claudius Regaud,,1.0,,Study cancelled,f,,,,t,f,f,,,,,,,,,,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,OTHER,,,,,,,2020,0.0
NCT04836806,,2021-04-06,,,2021-08-16,2021-04-06,2021-04-08,ACTUAL,,,,,,,2021-08-16,2021-08-20,ACTUAL,2021-08,ESTIMATED,2021-08-31,2021-08,2021-08-31,2022-07,ESTIMATED,2022-07-31,2022-07,ESTIMATED,2022-07-31,,INTERVENTIONAL,,,Cetirizine and Famotidine for COVID-19,"Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Cetirizine and Famotidine in Reducing the Duration of Symptoms in Patients With COVID-19: A Pilot Study",WITHDRAWN,,PHASE4,0.0,ACTUAL,Emory University,,2.0,,Study stopped due to issues with enrollment and lack of funding.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,OTHER,,,,,,,2022,0.0
NCT04841538,,2021-04-08,,,2022-04-22,2021-04-08,2021-04-12,ACTUAL,,,,,,,2022-04-22,2022-04-29,ACTUAL,2021-07,ESTIMATED,2021-07-31,2022-04,2022-04-30,2024-05,ESTIMATED,2024-05-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,A Study of ES101 (PD-L1x4-1BB Bispecific Antibody) in Patients With Advanced Malignant Thoracic Tumors,"An Open-label, Multicenter, Multicohort Phase 1b/2 Clinical Trial of ES101 in Patients With Advanced Malignant Thoracic Tumors",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Elpiscience Biopharma, Ltd.",,6.0,,Sponsor's clinical development strategy adjustment,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,INDUSTRY,,,,,,,2024,0.0
NCT03175978,,2017-05-25,2023-08-11,,2024-05-15,2017-05-31,2017-06-05,ACTUAL,2024-05-15,2024-05-21,ACTUAL,,,,2024-05-15,2024-05-21,ACTUAL,2018-02-21,ACTUAL,2018-02-21,2024-05,2024-05-31,2021-09-30,ACTUAL,2021-09-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,,,IGF-MTX Conjugate in the Treatment of Myelodysplastic Syndrome,"Pilot Study of IGF-Methotrexate Conjugate in the Treatment of Myelodysplastic Syndrome, CMML and Oligoblastic AML",TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,"IGF Oncology, LLC",,1.0,,Funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,INDUSTRY,,,,,,,2021,0.0
NCT04583423,,2020-10-05,2024-03-06,,2024-04-04,2020-10-09,2020-10-12,ACTUAL,2024-04-04,2024-04-29,ACTUAL,,,,2024-04-04,2024-04-29,ACTUAL,2020-11-11,ACTUAL,2020-11-11,2024-04,2024-04-30,2023-04-13,ACTUAL,2023-04-13,2023-04-13,ACTUAL,2023-04-13,,INTERVENTIONAL,,,A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001),"A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.",TERMINATED,,PHASE2,183.0,ACTUAL,Merck Sharp & Dohme LLC,,4.0,,Business reasons,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,INDUSTRY,,,,,,,2023,0.0
NCT04750239,,2021-02-06,2023-06-20,,2023-08-11,2021-02-06,2021-02-11,ACTUAL,2023-08-11,2023-08-14,ACTUAL,,,,2023-08-11,2023-08-14,ACTUAL,2021-08-17,ACTUAL,2021-08-17,2023-06,2023-06-30,2022-04-08,ACTUAL,2022-04-08,2022-04-08,ACTUAL,2022-04-08,,INTERVENTIONAL,,Safety Analysis Set,Safety and Clinical Activity of Nivatrotamab in Relapsed/Recurrent Metastatic Small-cell Lung Cancer,"Safety and Clinical Activity of Nivatrotamab, an Anti GD2×CD3 Bispecific Antibody, in Relapsed/Recurrent Metastatic Small-cell Lung Cancer An Open-label, Single-arm, Multicenter, Phase 1/2 Trial",TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,Y-mAbs Therapeutics,The study was terminated after 3 subjects due to a business strategy decision. At this point the maximum tolerated dose was not established. Only 3 subjects at dose level 1 (nivatrotamab 50 mcg) were enrolled.,1.0,,Study terminated due to business priorities,f,,,,t,t,f,,,,,,,,,,,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,INDUSTRY,,,,,,,2022,0.0
NCT04231643,,2020-01-08,,,2024-05-08,2020-01-13,2020-01-18,ACTUAL,,,,,,,2024-05-08,2024-05-10,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2024-05,2024-05-31,2023-11-28,ACTUAL,2023-11-28,2023-11-28,ACTUAL,2023-11-28,,INTERVENTIONAL,,,Effects of Cannabis on Cognition and Endocannabinoid Levels in Bipolar Disorder Patients and Healthy Volunteers,"A Randomized, Controlled Trial of Cannabis in Bipolar Disorder Patients and Healthy Volunteers Evaluating Cognition and Endocannabinoid Levels",TERMINATED,,EARLY_PHASE1,19.0,ACTUAL,"University of California, San Diego",,2.0,,Budgetary limitations prevented us from completing our planned sample size.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,OTHER,,,,,,,2023,0.0
NCT03567616,,2018-06-12,2021-06-09,,2021-06-09,2018-06-21,2018-06-26,ACTUAL,2021-06-09,2021-06-30,ACTUAL,,,,2021-06-09,2021-06-30,ACTUAL,2018-10-18,ACTUAL,2018-10-18,2021-06,2021-06-30,2020-06-18,ACTUAL,2020-06-18,2020-06-18,ACTUAL,2020-06-18,,INTERVENTIONAL,,Full Analysis Set: participants who received at least 1 dose of study drug,A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma,"A Phase 2, Open-Label, Multicenter, Dose-Escalation and Expansion Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma",TERMINATED,,PHASE2,8.0,ACTUAL,AbbVie,,3.0,,"Following results of the primary progression-free survival analysis from Study NCT02755597, company-sponsored MM studies were placed on partial clinical hold (PCH). Sponsor did not pursue release of the PCH for this study.",t,,,,f,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,INDUSTRY,,NCT03123029,AVAILABLE,,,,2020,0.0
NCT03575351,,2018-06-14,,,2023-11-13,2018-06-28,2018-07-02,ACTUAL,,,,,,,2023-11-13,2023-11-15,ACTUAL,2018-10-23,ACTUAL,2018-10-23,2023-11,2023-11-30,2023-10-23,ACTUAL,2023-10-23,2023-10-23,ACTUAL,2023-10-23,,INTERVENTIONAL,TRANSFORM,,"A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas","A Global Randomized Multicenter Phase 3 Trial of JCAR017 Compared to Standard of Care in Adult Subjects With High-risk, Second-line, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM).",COMPLETED,,PHASE3,184.0,ACTUAL,Celgene,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,INDUSTRY,,,,,,,2023,1.0
NCT04878211,,2021-05-03,2024-03-25,,2024-06-17,2021-05-06,2021-05-07,ACTUAL,2024-06-17,2024-06-20,ACTUAL,,,,2024-06-17,2024-06-20,ACTUAL,2021-06-10,ACTUAL,2021-06-10,2024-06,2024-06-30,2023-04-14,ACTUAL,2023-04-14,2023-04-14,ACTUAL,2023-04-14,,INTERVENTIONAL,,There were no participants enrolled in Cohort 3.,A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab,An Open-label Multicenter Study to Assess Response to COVID-19 Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously,TERMINATED,,PHASE4,24.0,ACTUAL,Novartis,,6.0,,Trial was terminated for business reasons. There has been no change in the benefit/risk profile of ofatumumab.,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.",2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,INDUSTRY,,,,,,,2023,0.0
NCT03340909,,2017-11-02,,,2022-07-28,2017-11-08,2017-11-14,ACTUAL,,,,,,,2022-07-28,2022-08-01,ACTUAL,2018-02-02,ACTUAL,2018-02-02,2022-07,2022-07-31,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,NorPEPS,,The Norwegian Prednisolone in Early Psychosis Study,The Norwegian Prednisolone in Early Psychosis Study - NorPEPS. The Role of Immune-modulating Strategies in the Treatment of Psychosis,TERMINATED,,PHASE2,12.0,ACTUAL,Haukeland University Hospital,,2.0,,Stopped because of COVID 19 pandemic,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,OTHER,,,,,,,2021,0.0
NCT02657343,,2016-01-13,2021-09-29,,2022-07-28,2016-01-13,2016-01-15,ESTIMATED,2022-05-10,2022-06-03,ACTUAL,,,,2022-07-28,2022-08-01,ACTUAL,2016-03-09,ACTUAL,2016-03-09,2022-07,2022-07-31,2022-06-30,ACTUAL,2022-06-30,2020-08-27,ACTUAL,2020-08-27,,INTERVENTIONAL,,never enrolled to cohort C,"An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.","An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.",COMPLETED,,PHASE1/PHASE2,25.0,ACTUAL,Dana-Farber Cancer Institute,,3.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,OTHER,,,,,,,2022,1.0
NCT03336580,,2017-10-23,,,2020-08-18,2017-11-03,2017-11-08,ACTUAL,,,,,,,2020-08-18,2020-08-20,ACTUAL,2018-04-05,ACTUAL,2018-04-05,2020-08,2020-08-31,2020-07-23,ACTUAL,2020-07-23,2020-07-23,ACTUAL,2020-07-23,,INTERVENTIONAL,,,A Study of PRX004 in Subjects With Amyloid Transthyretin (ATTR) Amyloidosis,"A Phase 1, Open-label, Dose Escalation Study of Intravenous PRX004 in Subjects With Amyloid Transthyretin (ATTR) Amyloidosis",TERMINATED,,PHASE1,21.0,ACTUAL,Prothena Biosciences Limited,,1.0,,Because of the impact of COVID-19 pandemic,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,INDUSTRY,,,,,,,2020,0.0
NCT04112199,,2019-09-30,,2024-05-06,2024-05-07,2019-09-30,2019-10-02,ACTUAL,,,,,2023-07-07,ACTUAL,2024-05-07,2024-05-08,ACTUAL,2021-06-17,ACTUAL,2021-06-17,2024-05,2024-05-31,2023-05-08,ACTUAL,2023-05-08,2023-05-08,ACTUAL,2023-05-08,,INTERVENTIONAL,,,A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites,"A Phase 2 Randomized, Dose-Titration, Open-Label Study Evaluating the Safety and Efficacy of BIV201 Compared to Standard of Care to Reduce Ascites and Complications in Cirrhotic Patients With Refractory Ascites",TERMINATED,,PHASE2,15.0,ACTUAL,BioVie Inc.,,2.0,,For reasons unrelated to safety or efficacy,f,,,,t,t,f,,,,,,,,,NO,De-identified individual participant data for primary and secondary end-points may be made available after NDA filing.,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,INDUSTRY,,,,,,,2023,0.0
NCT03988205,,2019-06-12,2022-04-17,,2022-07-17,2019-06-12,2019-06-17,ACTUAL,2022-07-17,2022-07-19,ACTUAL,,,,2022-07-17,2022-07-19,ACTUAL,2019-08-28,ACTUAL,2019-08-28,2022-07,2022-07-31,2022-04-01,ACTUAL,2022-04-01,2021-12-01,ACTUAL,2021-12-01,,INTERVENTIONAL,,,Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia,The Feasibility of Safely Managing Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia (AML) in an Outpatient Environment,TERMINATED,,PHASE4,3.0,ACTUAL,Medical College of Wisconsin,,1.0,,Low accrual,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,OTHER,,,,,,,2022,0.0
NCT04124367,,2019-10-10,,,2022-07-26,2019-10-10,2019-10-11,ACTUAL,,,,,,,2022-07-26,2022-07-28,ACTUAL,2021-06-25,ACTUAL,2021-06-25,2022-07,2022-07-31,2022-03-21,ACTUAL,2022-03-21,2022-03-21,ACTUAL,2022-03-21,,INTERVENTIONAL,IMPULSE,,IMPULSE - StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE,"IMPULSE StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE A Prospective, Multi-center, Randomized, Double-blind Study to Assess Efficacy and Safety of Neuroplastic Intervention by Cerebrolysin and atDCS on Motor Function Recovery in Subacute and Chronic Stroke Patients",TERMINATED,,PHASE2,4.0,ACTUAL,Ever Neuro Pharma GmbH,,2.0,,for strategic and pandemic reasons,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 06:27:05.049356,2024-10-16 06:27:05.049356,INDUSTRY,,,,,,,2022,0.0
NCT04792008,,2021-03-04,,,2023-12-03,2021-03-08,2021-03-10,ACTUAL,,,,,,,2023-12-03,2023-12-08,ACTUAL,2021-03-10,ACTUAL,2021-03-10,2023-03,2023-03-31,2023-08-31,ACTUAL,2023-08-31,2023-08-31,ACTUAL,2023-08-31,,INTERVENTIONAL,YAN,,YQ23 Study in Patients With Critical Limb Ischaemia,"A Randomised, Double-Blind, Phase 1b/2a, Placebo-Controlled, Single Dose Study to Evaluate Safety, Tolerability, and Efficacy of YQ23 in Adult Patients With Critical Limb Ischaemia",TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,New Beta Innovation Limited,,2.0,,Due to business decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,INDUSTRY,,,,,,,2023,0.0
NCT02759588,,2016-04-25,,,2023-01-03,2016-04-29,2016-05-03,ESTIMATED,,,,,,,2023-01-03,2023-01-05,ACTUAL,2016-05,,2016-05-31,2023-01,2023-01-31,2022-12-31,ACTUAL,2022-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer,Phase 1b & 2 Study With GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer (VIRO-15),COMPLETED,,PHASE1/PHASE2,46.0,ACTUAL,Genelux Corporation,,1.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,INDUSTRY,,,,,,,2022,1.0
NCT03095612,,2017-03-23,2023-12-21,,2024-06-12,2017-03-23,2017-03-29,ACTUAL,2024-06-12,2024-06-13,ACTUAL,,,,2024-06-12,2024-06-13,ACTUAL,2018-03-22,ACTUAL,2018-03-22,2024-06,2024-06-30,2023-03-03,ACTUAL,2023-03-03,2022-11-08,ACTUAL,2022-11-08,,INTERVENTIONAL,,"41 subjects were consented, but 1 screen failed and only 40 total were assigned to combination treatment cohort. 2nd dose level of 80 mg +docetaxel 75 mg/m2 was not tolerated and hence did not proceed to next dose of 100 mg+ docetaxel 75 mg/m2 as well. The study was halted prior to participants receiving any of the selinexor monotherapy. No data was collected or analyzed for the selinexor Monotherapy cohort.",Phase 1/2 Trial of Selinexor (KPT-330) With Docetaxel for Non-small Cell Lung Cancer (NSCLC),"An Investigator-sponsored, Phase 1/2 Trial of the Oral XPO1 Inhibitor Selinexor (KPT-330) Monotherapy and in Combination With Docetaxel for Previously Treated, Advanced KRAS Mutant Non-small Cell Lung Cancer (NSCLC)",TERMINATED,,PHASE1/PHASE2,41.0,ACTUAL,University of Texas Southwestern Medical Center,,1.0,,Funding Sponsor no longer supporting study,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,OTHER,,,,,,,2023,0.0
NCT04372082,,2020-04-30,,,2021-03-08,2020-04-30,2020-05-01,ACTUAL,,,,,,,2021-03-08,2021-03-11,ACTUAL,2020-05,ESTIMATED,2020-05-31,2020-04,2020-04-30,2023-05,ESTIMATED,2023-05-31,2023-05,ESTIMATED,2023-05-31,,INTERVENTIONAL,HYdILIC,,Hydroxychloroquine or Diltiazem-Niclosamide for the Treatment of COVID-19,"Efficacy of HYdroxychloroquine and DILtiazem-nIClosamide Combination for the Treatment of Non-severe Forms of SARS-CoV2 Infection in Patients With Co-morbidities: Multicenter, Randomized, Open-labeled Controlled Trial",WITHDRAWN,,PHASE3,0.0,ACTUAL,"University Hospital, Lille",,3.0,,evidence showed chloroquine is not effective against COVID-19,f,,,,t,f,f,,,,,,,,,,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,OTHER,,,,,,,2023,0.0
NCT03703336,,2018-10-09,2021-01-05,,2021-01-05,2018-10-09,2018-10-11,ACTUAL,2021-01-05,2021-01-25,ACTUAL,,,,2021-01-05,2021-01-25,ACTUAL,2019-03-16,ACTUAL,2019-03-16,2020-11,2020-11-30,2020-01-08,ACTUAL,2020-01-08,2020-01-08,ACTUAL,2020-01-08,,INTERVENTIONAL,,"Safety population, as treated",Phase III Study of Liquid Formulation of ROTAVIN,"A Phase III, Randomized, Partially Double- Blind, Active Control Study to Compare the Immunogenicity and Safety of a Liquid Formulation of ROTAVIN With the Currently Licensed Frozen Formulation of the Vaccine (ROTAVIN-M1), in Healthy Vietnamese Infants",COMPLETED,,PHASE3,825.0,ACTUAL,"Center for Research and Production of Vaccines and Biologicals, Vietnam",,2.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,OTHER_GOV,,,,,,,2020,1.0
NCT02539225,,2015-08-31,2018-08-23,,2022-02-23,2015-08-31,2015-09-02,ESTIMATED,2018-10-02,2019-02-15,ACTUAL,,,,2022-02-23,2022-03-08,ACTUAL,2015-10-05,ACTUAL,2015-10-05,2022-02,2022-02-28,2021-03-10,ACTUAL,2021-03-10,2017-10-25,ACTUAL,2017-10-25,,INTERVENTIONAL,,All randomized participants who received any quantity of study drug.,A Study of Ramucirumab in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma,"A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of S-1 and Oxaliplatin With or Without Ramucirumab as First-line Therapy Followed by Paclitaxel With Ramucirumab as Second-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma",COMPLETED,,PHASE2,191.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,,,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,INDUSTRY,,,,,,,2021,1.0
NCT04149379,,2019-10-29,,,2020-04-23,2019-10-30,2019-11-04,ACTUAL,,,,,,,2020-04-23,2020-04-27,ACTUAL,2020-04-20,ESTIMATED,2020-04-20,2020-04,2020-04-30,2021-12-20,ESTIMATED,2021-12-20,2021-08-31,ESTIMATED,2021-08-31,,INTERVENTIONAL,,,Hyperbaric Oxygen Therapy After Stroke - PILOT,Hyperbaric Oxygen Therapy After Cerebral Infarction - PILOT,WITHDRAWN,,PHASE2,0.0,ACTUAL,Norwegian Underwater Intervention (NUI),,1.0,,Because of the economic consequences of the COVID-19 pandemic 2020,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,INDUSTRY,,,,,,,2021,0.0
NCT04349098,,2020-04-14,2021-10-05,,2023-01-19,2020-04-14,2020-04-16,ACTUAL,2021-10-27,2021-11-01,ACTUAL,,,,2023-01-19,2023-01-20,ACTUAL,2020-04-17,ACTUAL,2020-04-17,2023-01,2023-01-31,2020-10-05,ACTUAL,2020-10-05,2020-10-05,ACTUAL,2020-10-05,,INTERVENTIONAL,Coronavirus,PV 1-6 population included participants randomized into the study under protocol versions 1-6.,Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection,A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients With Severe COVID-19 Infection,COMPLETED,,PHASE2,190.0,ACTUAL,Karyopharm Therapeutics Inc,,2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,INDUSTRY,,,,,,,2020,1.0
NCT04519567,,2020-08-17,,,2021-06-29,2020-08-17,2020-08-19,ACTUAL,,,,,,,2021-06-29,2021-06-30,ACTUAL,2020-07-31,ACTUAL,2020-07-31,2021-06,2021-06-30,2021-03-16,ACTUAL,2021-03-16,2021-03-16,ACTUAL,2021-03-16,,INTERVENTIONAL,,,Multiple Ascending Dose Study of CTI-1601 Versus Placebo in Subjects With Friedreich's Ataxia,"A Phase 1 Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CTI-1601 Versus Placebo in Subjects With Friedreich's Ataxia",COMPLETED,,PHASE1,27.0,ACTUAL,"Larimar Therapeutics, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,INDUSTRY,,,,,,,2021,1.0
NCT03844932,,2019-01-31,,,2021-05-04,2019-02-18,2019-02-19,ACTUAL,,,,,,,2021-05-04,2021-05-07,ACTUAL,2019-01-24,ACTUAL,2019-01-24,2021-05,2021-05-31,2021-04-14,ACTUAL,2021-04-14,2021-04-14,ACTUAL,2021-04-14,,INTERVENTIONAL,,,A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis,"A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis",TERMINATED,,PHASE2,235.0,ACTUAL,Sublimity Therapeutics Holdco Limited,,4.0,,The Sublimity Board of Directors carefully evaluated the IA data: the 9.6% treatment remission difference for 75mg BID vs placebo (due to an increase in placebo response rate) was determined not sufficient to continue to fund the study,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,INDUSTRY,,,,,,,2021,0.0
NCT04771780,,2021-02-16,,,2023-07-31,2021-02-22,2021-02-25,ACTUAL,,,,,,,2023-07-31,2023-08-02,ACTUAL,2021-03-15,ACTUAL,2021-03-15,2023-07,2023-07-31,2022-06-27,ACTUAL,2022-06-27,2022-06-27,ACTUAL,2022-06-27,,INTERVENTIONAL,,,Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis,"A Phase 3, Long-term, Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis",COMPLETED,,PHASE3,213.0,ACTUAL,"Kyowa Kirin Co., Ltd.",,1.0,,,f,,,,f,f,f,,,,,,,,,YES,"The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.",2024-10-15 18:15:15.515763,2024-10-15 18:15:15.515763,INDUSTRY,,,,,,,2022,1.0
NCT04502433,,2020-08-03,2023-03-16,,2023-05-31,2020-08-05,2020-08-06,ACTUAL,2023-05-31,2023-06-23,ACTUAL,,,,2023-05-31,2023-06-23,ACTUAL,2021-01-06,ACTUAL,2021-01-06,2023-05,2023-05-31,2022-03-17,ACTUAL,2022-03-17,2022-03-17,ACTUAL,2022-03-17,,INTERVENTIONAL,,Intention-to-Treat (ITT) population used for this parameter.,Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS),"Multicenter, Open-label, Randomised Trial to Assess the Efficacy and Tolerability of Poractant Alfa(Porcine Surfactant, Curosurf®) in Hospitalized Patients With SARS-COV-19 Acute Respiratory Distress Syndrome (ARDS)",TERMINATED,,PHASE2,22.0,ACTUAL,Chiesi Farmaceutici S.p.A.,"Once the impact of the Covid 19 pandemic significantly declined and intubated patients with acute respiratory distress syndrome (ARDS) outcome became rare, the Sponsor considered it unfeasible to maintain efforts to recruit further patients into the study. Thus, due to low recruitment, the study was terminated early for non-safety reasons.",2.0,,"The enrolment was extended. Nevertheless, despite the Sponsor's attempts, the infection status did not permit the identification of eligible patients for the study to complete it in a reasonable time.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,INDUSTRY,,,,,,,2022,0.0
NCT01930123,,2013-08-23,2022-08-09,2021-11-07,2022-08-09,2013-08-27,2013-08-28,ESTIMATED,2022-08-09,2022-08-31,ACTUAL,2022-01-13,2022-01-19,ACTUAL,2022-08-09,2022-08-31,ACTUAL,2013-10,,2013-10-31,2022-08,2022-08-31,2020-01,ACTUAL,2020-01-31,2020-01,ACTUAL,2020-01-31,,INTERVENTIONAL,,Participants who completed the study.,"Impact of Fructose on Metabolism, Energy Homeostasis and Magnetic Resonance Biomarkers in Nonalcoholic Fatty Liver Disease","Impact of Fructose on Metabolism, Energy Homeostasis and Magnetic Resonance (MR) Biomarkers in Nonalcoholic Fatty Liver Disease (NAFLD)",TERMINATED,,PHASE2,118.0,ACTUAL,Duke University,,2.0,,Insufficient enrollment.,f,,,,f,,,,,,,,,,,,,2024-10-15 08:43:11.341025,2024-10-15 08:43:11.341025,OTHER,,,,,,,2020,0.0
NCT04183335,,2019-11-27,2022-11-11,,2022-11-11,2019-12-02,2019-12-03,ACTUAL,2022-11-11,2022-12-12,ACTUAL,,,,2022-11-11,2022-12-12,ACTUAL,2019-12-12,ACTUAL,2019-12-12,2022-11,2022-11-30,2022-02-03,ACTUAL,2022-02-03,2021-11-12,ACTUAL,2021-11-12,,INTERVENTIONAL,,Analysis was performed on randomized population.,"Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME)","A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable",COMPLETED,,PHASE3,151.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,INDUSTRY,,,,,,,2022,1.0
NCT03047005,,2017-02-05,2022-11-30,,2024-02-01,2017-02-05,2017-02-08,ESTIMATED,2023-04-14,2023-05-06,ACTUAL,,,,2024-02-01,2024-02-02,ACTUAL,2017-08-28,ACTUAL,2017-08-28,2024-02,2024-02-29,2022-12-16,ACTUAL,2022-12-16,2021-12-16,ACTUAL,2021-12-16,,INTERVENTIONAL,,,Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy,Behavioral and Pharmacologic Treatment of Binge Eating and Obesity,COMPLETED,,PHASE2/PHASE3,68.0,ACTUAL,Yale University,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 06:27:05.049356,2024-10-16 06:27:05.049356,OTHER,,,,,,,2022,1.0
NCT03795350,,2018-12-18,,,2022-05-02,2019-01-04,2019-01-07,ACTUAL,,,,,,,2022-05-02,2022-05-06,ACTUAL,2019-01-14,ACTUAL,2019-01-14,2022-05,2022-05-31,2020-04-03,ACTUAL,2020-04-03,2020-04-03,ACTUAL,2020-04-03,,INTERVENTIONAL,STORM,,"Lung Deposition of TRIMBOW® pMDI in Healthy Volunteers, Asthmatic and COPD Patients","Open Label, Uncontrolled, Non-randomized, Single Dose, Scintigraphic Study to Investigate Lung Deposition of Inhaled 99mTc Radiolabelled TRIMBOW® pMDI in Healthy Volunteers, Asthmatic and COPD Patients",TERMINATED,,PHASE1,19.0,ACTUAL,Chiesi Farmaceutici S.p.A.,,1.0,,"In light of the cessation of non-essential clinical activities at CPU due to the COVID-19 pandemic, the sponsor has determined to terminate the study early.",f,,,,,f,f,,,,,,,,,NO,,2024-10-16 06:27:05.049356,2024-10-16 06:27:05.049356,INDUSTRY,,,,,,,2020,0.0
NCT04853329,,2021-03-02,,,2023-10-18,2021-04-19,2021-04-21,ACTUAL,,,,,,,2023-10-18,2023-10-23,ACTUAL,2021-12-13,ACTUAL,2021-12-13,2023-10,2023-10-31,2024-12,ESTIMATED,2024-12-31,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Dose Escalation and Expansion Study of CPO107 for Patients With Advanced CD20-positive Non-Hodgkins Lymphoma,"Phase 1/2, Multicenter, First-In-Human, Dose Escalation and Dose Expansion Study of CPO107 Administered Intravenously to Patients With Advanced CD20-positive Non-Hodgkins Lymphoma",SUSPENDED,,PHASE1/PHASE2,7.0,ACTUAL,"Conjupro Biotherapeutics, Inc.",,3.0,,Business reasons,f,,,,f,t,f,,,,,,,,,NO,Undecided,2024-10-16 06:27:05.049356,2024-10-16 06:27:05.049356,INDUSTRY,,,,,,,2024,0.0
NCT04178590,,2019-11-21,2020-03-29,,2020-07-09,2019-11-25,2019-11-26,ACTUAL,2020-05-28,2020-06-11,ACTUAL,,,,2020-07-09,2020-07-13,ACTUAL,2019-10-02,ACTUAL,2019-10-02,2020-07,2020-07-31,2020-07-09,ACTUAL,2020-07-09,2020-06-29,ACTUAL,2020-06-29,,INTERVENTIONAL,EIPRFITCP,32 participants,Effect of Injectable Platelet-Rich Fibrin (i-PRF) in Initial Treatment of Chronic Periodontitis,Effects of Application Injectable Platelet-Rich Fibrin (i-PRF) as Adjunct Therapy in the Initial Treatment of Periodontitis,COMPLETED,,PHASE4,32.0,ACTUAL,University of Belgrade,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 06:27:05.049356,2024-10-16 06:27:05.049356,OTHER,,,,,periodontal pocket,,2020,1.0
NCT05231603,,2022-01-27,,,2022-10-14,2022-02-08,2022-02-09,ACTUAL,,,,,,,2022-10-14,2022-10-18,ACTUAL,2022-02-16,ACTUAL,2022-02-16,2022-10,2022-10-31,2022-10-11,ACTUAL,2022-10-11,2022-05-31,ACTUAL,2022-05-31,,INTERVENTIONAL,I-CPEP,,Ivermectin for Post Exposure Prophylaxis of Covid-19,"Randomized, Double Blind, Placebo Controlled Clinical Trial of Ivermectin For Post Exposure Prophylaxis For COVID-19 Infection Among Close Contacts",TERMINATED,,PHASE3,50.0,ACTUAL,"Clinical Research Centre, Malaysia",,2.0,,Poor response,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 16:26:15.425916,2024-10-16 16:26:15.425916,OTHER,,,,,,,2022,0.0
NCT04366960,,2020-04-24,,,2021-06-07,2020-04-27,2020-04-29,ACTUAL,,,,,,,2021-06-07,2021-06-08,ACTUAL,2020-05-14,ACTUAL,2020-05-14,2021-06,2021-06-30,2021-05-25,ACTUAL,2021-05-25,2021-05-25,ACTUAL,2021-05-25,,INTERVENTIONAL,X-Covid 19,,Comparison of Two Doses of Enoxaparin for Thromboprophylaxis in Hospitalized COVID-19 Patients,Enoxaparin for Thromboprophylaxis in Hospitalized COVID-19 Patients: Comparison of 40 mg o.d. Versus 40 mg b.i.d. A Randomized Clinical Trial,COMPLETED,,PHASE3,189.0,ACTUAL,Niguarda Hospital,,2.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 16:32:11.32067,2024-10-16 16:32:11.32067,OTHER,,,,,,,2021,1.0
NCT02709655,,2016-03-11,2022-07-15,,2022-08-29,2016-03-15,2016-03-16,ESTIMATED,2022-08-29,2022-09-22,ACTUAL,,,,2022-08-29,2022-09-22,ACTUAL,2016-05-18,ACTUAL,2016-05-18,2022-08,2022-08-31,2022-01-21,ACTUAL,2022-01-21,2022-01-21,ACTUAL,2022-01-21,,INTERVENTIONAL,,All-patients-treated set Phase A (APTS_A) included all participants enrolled to the 4-week Single-blind period (Phase A) who received at least 1 dose of study drug.,Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD),"Interventional, Randomized, Double-blind, Placebo-controlled, Active-reference (Fluoxetine), Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years, With Major Depressive Disorder (MDD)",COMPLETED,,PHASE3,683.0,ACTUAL,H. Lundbeck A/S,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,INDUSTRY,,,,,,,2022,1.0
NCT03419403,,2018-01-26,2021-02-16,2020-08-26,2021-03-19,2018-01-26,2018-02-05,ACTUAL,2021-03-19,2021-04-14,ACTUAL,2021-03-19,2021-04-14,ACTUAL,2021-03-19,2021-04-14,ACTUAL,2018-07-30,ACTUAL,2018-07-30,2021-03,2021-03-31,2020-03-03,ACTUAL,2020-03-03,2019-09-05,ACTUAL,2019-09-05,,INTERVENTIONAL,,Safety population: All randomized participants who received at least 1 dose of depatuxizumab mafodotin,UNITE Study: Understanding New Interventions With GBM ThErapy,Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414),TERMINATED,,PHASE3,40.0,ACTUAL,AbbVie,,3.0,,The study was terminated because clinical development of depatuxizumab mafodotin in glioblastoma was stopped due to lack of survival benefit.,t,,,,f,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 16:32:11.32067,2024-10-16 16:32:11.32067,INDUSTRY,,NCT03123952,NO_LONGER_AVAILABLE,,,,2020,0.0
NCT04180969,,2019-11-24,,,2023-04-10,2019-11-25,2019-11-29,ACTUAL,,,,,,,2023-04-10,2023-04-13,ACTUAL,2023-04-10,ACTUAL,2023-04-10,2023-04,2023-04-30,2023-04-10,ACTUAL,2023-04-10,2023-04-10,ACTUAL,2023-04-10,,INTERVENTIONAL,TSM-1,,rTMS of Limbic Circuitry in Stress Modulation in Healthy Volunteers,Impact of Repetitive Transcranial Magnetic Stimulation (rTMS) of Limbic Brain Circuitry in Stress Modulation in a Healthy Population,WITHDRAWN,,PHASE2,0.0,ACTUAL,Wayne State University,,4.0,,Lack of funding,f,,,,t,f,f,,,,,,Materials will only become available after the study is completed and the first manuscript from this project is published.,Qualified investigators may apply in writing to Dr. Greenwald,,YES,Full sharing plan is being developed.,2024-10-16 16:32:11.32067,2024-10-16 16:32:11.32067,OTHER,,,,,,,2023,0.0
NCT03828539,,2019-02-01,2021-07-16,,2021-10-07,2019-02-01,2019-02-04,ACTUAL,2021-07-16,2021-08-09,ACTUAL,,,,2021-10-07,2021-10-11,ACTUAL,2019-02-22,ACTUAL,2019-02-22,2021-10,2021-10-31,2020-07-29,ACTUAL,2020-07-29,2020-07-29,ACTUAL,2020-07-29,,INTERVENTIONAL,HER-MES,Demographic variables and other baseline characteristics were summarized for each randomized treatment group and for all patients (total) using the Full Analysis set (FAS),Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine,"Head-to-head Study of Erenumab Against topiRamate-a Double-blind, Double Dummy Migraine Study to Assess Tolerability and Efficacy in a patiEnt -Centered Setting",COMPLETED,,PHASE4,777.0,ACTUAL,Novartis,,2.0,,,f,,,,f,t,f,,,t,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 16:32:11.32067,2024-10-16 16:32:11.32067,INDUSTRY,,,,,,,2020,1.0
NCT04692155,,2020-12-28,2023-06-30,,2023-09-27,2020-12-28,2020-12-31,ACTUAL,2023-09-27,2023-09-28,ACTUAL,,,,2023-09-27,2023-09-28,ACTUAL,2021-08-31,ACTUAL,2021-08-31,2023-09,2023-09-30,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,CHOP U2,,Clinical Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL),Phase Ib/II Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL),TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,University of Alabama at Birmingham,,1.0,,FDA hold,,,,,t,t,f,,,,,,,,,,,2024-10-16 16:32:11.32067,2024-10-16 16:32:11.32067,OTHER,,,,,,,2022,0.0
NCT04015557,,2019-05-28,,,2021-06-25,2019-07-09,2019-07-11,ACTUAL,,,,,,,2021-06-25,2021-06-30,ACTUAL,2022-02-11,ESTIMATED,2022-02-11,2021-06,2021-06-30,2022-12-01,ESTIMATED,2022-12-01,2022-06-30,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,Effect of Acetaminophen and N-Acetylcysteine on Liver Metabolism on Homocystinuria,"Functional Consequences and Therapeutic Intervention in Hampered Production of Cysteine, Glutathione and Taurine in Classical Homocystinuria",SUSPENDED,,PHASE1/PHASE2,10.0,ESTIMATED,Hospital de Clinicas de Porto Alegre,,2.0,,Study was interrupted due to COVID-19 pandemic,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 06:27:05.049356,2024-10-16 06:27:05.049356,OTHER,,,,,,,2022,0.0
NCT03113617,,2017-04-10,2023-04-18,,2023-11-18,2017-04-10,2017-04-13,ACTUAL,2023-05-22,2023-05-24,ACTUAL,,,,2023-11-18,2023-12-12,ACTUAL,2017-04-10,ACTUAL,2017-04-10,2023-11,2023-11-30,2021-12-19,ACTUAL,2021-12-19,2021-12-19,ACTUAL,2021-12-19,,INTERVENTIONAL,,,68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer,68Ga-RM2 PET/CT for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer,COMPLETED,,PHASE2,44.0,ACTUAL,Stanford University,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,OTHER,,,,,,,2021,1.0
NCT05447507,,2022-06-21,,,2022-11-22,2022-07-01,2022-07-07,ACTUAL,,,,,,,2022-11-22,2022-11-29,ACTUAL,2022-07-08,ACTUAL,2022-07-08,2022-11,2022-11-30,2022-10-26,ACTUAL,2022-10-26,2022-10-26,ACTUAL,2022-10-26,,INTERVENTIONAL,,,Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation,Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation During Regional Block,COMPLETED,,PHASE4,104.0,ACTUAL,Seoul National University Hospital,,2.0,,,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,OTHER,,,,,,,2022,1.0
NCT03385564,,2017-12-21,2022-05-12,,2022-06-21,2017-12-21,2017-12-28,ACTUAL,2022-06-21,2022-07-13,ACTUAL,,,,2022-06-21,2022-07-13,ACTUAL,2018-01-09,ACTUAL,2018-01-09,2022-06,2022-06-30,2021-07-27,ACTUAL,2021-07-27,2021-05-25,ACTUAL,2021-05-25,,INTERVENTIONAL,,Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.,An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis,An Exploratory Maintenance Trial Evaluating the Effect of BI 655064 in Lupus Nephritis Patients Who Have Achieved a Meaningful Response Either at the End of 1293.10 or After an Induction Treatment Outside of 1293.10,COMPLETED,,PHASE2,69.0,ACTUAL,Boehringer Ingelheim,,4.0,,,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.",2024-10-15 08:48:18.10378,2024-10-15 08:48:18.10378,INDUSTRY,,,,,,,2021,1.0
NCT03780543,,2018-12-15,2022-12-23,2022-03-22,2023-03-24,2018-12-17,2018-12-19,ACTUAL,2023-01-24,2023-02-17,ACTUAL,2023-01-24,2023-02-17,ACTUAL,2023-03-24,2023-04-19,ACTUAL,2018-12-20,ACTUAL,2018-12-20,2023-02,2023-02-28,2021-04-26,ACTUAL,2021-04-26,2021-04-26,ACTUAL,2021-04-26,,INTERVENTIONAL,,,A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients,"A Multi-center, Open-label, Long-term Extension Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients",TERMINATED,,PHASE2,92.0,ACTUAL,Assembly Biosciences,,3.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 08:48:18.10378,2024-10-15 08:48:18.10378,INDUSTRY,,,,,,,2021,0.0
NCT04510584,,2020-08-09,,,2023-06-02,2020-08-09,2020-08-12,ACTUAL,,,,,,,2023-06-02,2023-06-06,ACTUAL,2021-07-16,ACTUAL,2021-07-16,2023-06,2023-06-30,2023-02-22,ACTUAL,2023-02-22,2023-02-22,ACTUAL,2023-02-22,,INTERVENTIONAL,,,Maintenance Treatment With Bevacizumab and Atezolizumab for Ovarian Cancer,Halting Early Advancement of Residual Disease by Treatment With Bevacizumab and Atezolizumab in Ovarian Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University Health Network, Toronto",,1.0,,"19 patients screenfailed, stopping recruitment before first patient enrollment to analyze pilot results from screening samples.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 08:48:18.10378,2024-10-15 08:48:18.10378,OTHER,,,,,,,2023,0.0
NCT03138889,,2017-05-01,2022-12-07,,2023-03-08,2017-05-01,2017-05-03,ACTUAL,2023-02-10,2023-03-09,ACTUAL,,,,2023-03-08,2023-03-10,ACTUAL,2017-06-09,ACTUAL,2017-06-09,2023-03,2023-03-31,2022-08-24,ACTUAL,2022-08-24,2022-07-05,ACTUAL,2022-07-05,,INTERVENTIONAL,PROPEL,"* Safety population: all patients who received at least one dose (or partial dose) of study treatment~* Dose-limiting toxicity (DLT) Population: all patients who completed at least the DLT observation period or discontinued from the study treatment due to DLT~* Response evaluable population: subjects who received at least 1 dose (or partial dose) of study drug, had measurable disease (per RECIST 1.1) at baseline, and had at least one post-baseline assessment of tumor response.",Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors,"A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of Combined Bempegaldesleukin (NKTR-214) and Pembrolizumab With or Without Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors",TERMINATED,,PHASE1/PHASE2,162.0,ACTUAL,Nektar Therapeutics,,6.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,INDUSTRY,,,,,,,2022,0.0
NCT04876716,,2021-04-14,,,2024-05-06,2021-05-05,2021-05-06,ACTUAL,,,,,,,2024-05-06,2024-05-07,ACTUAL,2021-05-11,ACTUAL,2021-05-11,2024-05,2024-05-31,2024-05-01,ACTUAL,2024-05-01,2024-05-01,ACTUAL,2024-05-01,,INTERVENTIONAL,IA-DUET,,Azole-echinocandin Combination Therapy for Invasive Aspergillosis,Azole-echinocandin Combination Therapy for Invasive Aspergillosis A Randomized Pragmatic Superiority Trial,TERMINATED,,PHASE3,66.0,ACTUAL,Erasmus Medical Center,,2.0,,futility,f,,,,f,f,f,,,,,,,,,,,2024-10-16 16:32:11.32067,2024-10-16 16:32:11.32067,OTHER,,,,,,,2024,0.0
NCT04191278,,2019-11-27,,,2021-08-31,2019-12-06,2019-12-09,ACTUAL,,,,,,,2021-08-31,2021-09-05,ACTUAL,2021-11,ESTIMATED,2021-11-30,2020-09,2020-09-30,2022-07,ESTIMATED,2022-07-31,2022-07,ESTIMATED,2022-07-31,,INTERVENTIONAL,HIVSMART,,Mobile Health Interventions for Medication Adherence Among PLWH,Mobile Health Interventions for Varenicline Adherence Among HIV-positive Smokers,WITHDRAWN,,PHASE4,0.0,ACTUAL,Duke University,,3.0,,COVID prevented study initiation,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 07:11:01.772078,2024-10-16 07:11:01.772078,OTHER,,,,,,,2022,0.0
NCT02743221,,2016-02-24,2019-01-15,,2024-07-24,2016-04-14,2016-04-19,ESTIMATED,2019-03-25,2019-04-16,ACTUAL,,,,2024-07-24,2024-08-20,ACTUAL,2016-04-29,ACTUAL,2016-04-29,2024-07,2024-07-31,2020-09-01,ACTUAL,2020-09-01,2018-01-15,ACTUAL,2018-01-15,,INTERVENTIONAL,TASCO1,,A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy,"An Open-label, Randomised, Non-comparative Phase 2 Study Evaluating S 95005 (TAS-102) Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Metastatic COlorectal Cancer Who Are Non-eligible for Intensive Therapy (TASCO1 Study).",COMPLETED,,PHASE2,154.0,ACTUAL,Servier,,2.0,,,f,,,,t,,f,,,t,,,After Marketing Authorisation in EEA or US if the study is used for the approval.,Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.,http://clinicaltrials.servier.com,YES,"Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.",2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,INDUSTRY,,,,,,,2020,1.0
NCT05154890,,2021-08-20,,,2023-07-25,2021-11-30,2021-12-13,ACTUAL,,,,,,,2023-07-25,2023-07-27,ACTUAL,2021-05-13,ACTUAL,2021-05-13,2023-07,2023-07-31,2023-04-21,ACTUAL,2023-04-21,2023-04-21,ACTUAL,2023-04-21,,INTERVENTIONAL,,,A Multiple Ascending Dose Study of ACN00177 (Pegtarviliase) in Subjects With CBS Deficiency,"A Phase 1/2 Multiple Ascending-Dose Study in Subjects With Homocystinuria Due to Cystathionine β-Synthase (CBS) Deficiency to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of ACN00177",TERMINATED,,PHASE1/PHASE2,13.0,ACTUAL,Aeglea Biotherapeutics,,5.0,,Sponsor Decision,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 16:32:11.32067,2024-10-16 16:32:11.32067,INDUSTRY,,,,,,,2023,0.0
NCT03887650,,2019-03-21,2023-07-17,,2023-09-11,2019-03-21,2019-03-25,ACTUAL,2023-09-11,2023-09-15,ACTUAL,,,,2023-09-11,2023-09-15,ACTUAL,2019-03-11,ACTUAL,2019-03-11,2023-09,2023-09-30,2022-03-08,ACTUAL,2022-03-08,2022-01-11,ACTUAL,2022-01-11,,INTERVENTIONAL,,,LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs,LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs: A Randomized Controlled Trial of Injection at the Brachial Plexus,COMPLETED,,PHASE4,90.0,ACTUAL,Hartford Hospital,"Opioid consumption was subjected to patient recall and reporting bias. Patients were advised by surgery clinics to limit opioid intake postoperatively, which might indirectly limit opioid use and made it more difficult to show a difference. The study was double-blinded, the anesthesiologists who performed the block, were unblinded due to the difference in the physical appearance of the study drugs.",2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,OTHER,,,,,,,2022,1.0
NCT00729118,,2008-08-06,,,2020-05-14,2008-08-06,2008-08-07,ESTIMATED,,,,,,,2020-05-14,2020-05-18,ACTUAL,2008-09-26,ACTUAL,2008-09-26,2020-05,2020-05-31,2020-05-04,ACTUAL,2020-05-04,2019-12-26,ACTUAL,2019-12-26,,INTERVENTIONAL,,,Vorinostat and Lenalidomide After Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma,Vorinostat (SAHA) and Lenalidomide After Autologous Transplant for Patients With Multiple Myeloma,COMPLETED,,PHASE1,19.0,ACTUAL,Ohio State University Comprehensive Cancer Center,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 07:11:01.772078,2024-10-16 07:11:01.772078,OTHER,,,,,,,2020,1.0
NCT04377620,,2020-05-04,2021-11-17,,2022-01-14,2020-05-04,2020-05-06,ACTUAL,2022-01-14,2022-01-19,ACTUAL,,,,2022-01-14,2022-01-19,ACTUAL,2020-05-24,ACTUAL,2020-05-24,2022-01,2022-01-31,2021-02-26,ACTUAL,2021-02-26,2021-02-26,ACTUAL,2021-02-26,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all participants who were randomized to the study.,Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT),"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)",TERMINATED,,PHASE3,211.0,ACTUAL,Incyte Corporation,,3.0,,Study terminated by sponsor,t,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 08:48:18.10378,2024-10-15 08:48:18.10378,INDUSTRY,,NCT04355793,NO_LONGER_AVAILABLE,,,,2021,0.0
NCT02928224,,2016-08-16,2020-05-06,2019-12-19,2023-12-01,2016-10-06,2016-10-10,ESTIMATED,2020-06-19,2020-07-14,ACTUAL,2019-12-19,2019-12-20,ACTUAL,2023-12-01,2023-12-21,ACTUAL,2016-10-13,ACTUAL,2016-10-13,2023-12,2023-12-31,2022-11-10,ACTUAL,2022-11-10,2019-02-11,ACTUAL,2019-02-11,,INTERVENTIONAL,BEACON CRC,"The baseline analysis population consists of the Full Analysis Set (FAS). For participants in the CSLI, the FAS includes all participants who received at least 1 dose of study drug and had at least 1 post treatment assessment, which may include death. For the randomized Phase 3 portion of the study, the FAS consists of all randomized participants.",Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer,"A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer",COMPLETED,,PHASE3,702.0,ACTUAL,Pfizer,,3.0,,,f,,,,t,t,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,INDUSTRY,,,,,,,2022,1.0
NCT04435366,,2020-05-12,2023-11-01,2023-07-21,2024-02-20,2020-06-15,2020-06-17,ACTUAL,2023-12-07,2023-12-28,ACTUAL,,2023-12-28,ACTUAL,2024-02-20,2024-02-23,ACTUAL,2020-06-22,ACTUAL,2020-06-22,2023-11,2023-11-30,2023-08-22,ACTUAL,2023-08-22,2022-07-25,ACTUAL,2022-07-25,,INTERVENTIONAL,,,A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor),"A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration",COMPLETED,,PHASE3,448.0,ACTUAL,Astellas Pharma Inc,,2.0,,,,,,,t,t,f,,,,,,,,,,,2024-10-16 06:27:05.049356,2024-10-16 06:27:05.049356,INDUSTRY,,,,,,,2023,1.0
NCT04076761,,2019-08-22,,,2022-11-28,2019-08-30,2019-09-03,ACTUAL,,,,,,,2022-11-28,2022-12-01,ACTUAL,2019-12-11,ACTUAL,2019-12-11,2022-11,2022-11-30,2022-09-30,ACTUAL,2022-09-30,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,MOCHA,,Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma,"A Multi-Centre, Open-Label Phase 2 Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma (The MOCHA Trial)",TERMINATED,,PHASE2,8.0,ACTUAL,Sunnybrook Health Sciences Centre,,1.0,,Lack of Funding,f,,,,f,f,f,,,,,,,,,,,2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,OTHER,,,,,,,2022,0.0
NCT05018975,,2021-08-19,,,2021-11-17,2021-08-20,2021-08-24,ACTUAL,,,,,,,2021-11-17,2021-11-22,ACTUAL,2022-01,ESTIMATED,2022-01-31,2021-08,2021-08-31,2023-09-21,ESTIMATED,2023-09-21,2023-09-21,ESTIMATED,2023-09-21,,INTERVENTIONAL,IST,,Tazemetostat for the Treatment of Moderate to Severe COVID-19 Infection,Repurposing Tazemetostat for the Treatment of Acute Respiratory Distress Syndrome (ARDS) or Systemic Cytokine Release Syndrome (SCRS) in COVID-19 Patient,WITHDRAWN,,PHASE2,0.0,ACTUAL,Loma Linda University,,2.0,,FDA recommendation cited safety issues,f,,,,,t,f,,,t,,,,,,,,2024-10-15 08:48:18.10378,2024-10-15 08:48:18.10378,OTHER,,,,,,,2023,0.0
NCT03787147,,2018-12-05,,,2021-01-12,2018-12-21,2018-12-26,ACTUAL,,,,,,,2021-01-12,2021-01-14,ACTUAL,2020-11-30,ESTIMATED,2020-11-30,2021-01,2021-01-31,2020-12-01,ESTIMATED,2020-12-01,2020-12-01,ESTIMATED,2020-12-01,,INTERVENTIONAL,VR adult,,Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI),Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI),WITHDRAWN,,PHASE2,0.0,ACTUAL,Albert Einstein College of Medicine,,3.0,,Never started the study cause of the lack of funding,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,OTHER,,,,,,,2020,0.0
NCT03086369,,2017-03-13,2021-12-14,,2022-06-03,2017-03-20,2017-03-22,ACTUAL,2021-12-14,2022-01-11,ACTUAL,,,,2022-06-03,2022-06-28,ACTUAL,2017-06-22,ACTUAL,2017-06-22,2022-06,2022-06-30,2021-06-17,ACTUAL,2021-06-17,2021-01-05,ACTUAL,2021-01-05,,INTERVENTIONAL,,All participants in phase 1b/2.,A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer,"A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer",COMPLETED,,PHASE1/PHASE2,184.0,ACTUAL,Eli Lilly and Company,,5.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,INDUSTRY,,,,,,,2021,1.0
NCT05450549,,2022-07-05,,,2023-08-14,2022-07-05,2022-07-08,ACTUAL,,,,,,,2023-08-14,2023-08-16,ACTUAL,2022-07-14,ACTUAL,2022-07-14,2023-08,2023-08-31,2023-06-08,ACTUAL,2023-06-08,2023-06-08,ACTUAL,2023-06-08,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants","A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants",COMPLETED,,PHASE1,47.0,ACTUAL,Denali Therapeutics Inc.,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 16:32:11.32067,2024-10-16 16:32:11.32067,INDUSTRY,,,,,,,2023,0.0
NCT04954196,,2021-07-05,,,2023-03-10,2021-07-05,2021-07-08,ACTUAL,,,,,,,2023-03-10,2023-03-13,ACTUAL,2021-10-08,ESTIMATED,2021-10-08,2023-03,2023-03-31,2024-09-08,ESTIMATED,2024-09-08,2023-10-08,ESTIMATED,2023-10-08,,INTERVENTIONAL,AMLODIP,,Benefit of Amlodipine in HRT Cycle for Frozen Embryo Transfer in the Correction of Uterine Pulsatility Index,Benefit of Amlodipine in HRT Cycle (Hormone Replacement Therapy) for Frozen Embryo Transfer in the Correction of Uterine Pulsatility Index: Randomized Controlled Double-blind Trial.,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University Hospital, Montpellier",,2.0,,No participants enrolled,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,OTHER,,,,,,,2024,0.0
NCT03177252,,2017-05-08,,,2020-10-20,2017-06-01,2017-06-06,ACTUAL,,,,,,,2020-10-20,2020-10-22,ACTUAL,2020-10-01,ESTIMATED,2020-10-01,2020-10,2020-10-31,2021-09-30,ESTIMATED,2021-09-30,2021-09-30,ESTIMATED,2021-09-30,,INTERVENTIONAL,Scalp block,,Scalp Block: Hemodynamic Stability and Patient Comfort In Craniotomy Patients,Scalp Block: Hemodynamic Stability and Patient Comfort In Craniotomy Patients,WITHDRAWN,,PHASE1,0.0,ACTUAL,Washington University School of Medicine,,2.0,,Investigator decided not to go forward with the trial.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,OTHER,,,,,,,2021,0.0
NCT04535986,,2020-08-19,2023-08-30,,2023-11-07,2020-09-01,2020-09-02,ACTUAL,2023-11-07,2023-11-13,ACTUAL,,,,2023-11-07,2023-11-13,ACTUAL,2020-09-29,ACTUAL,2020-09-29,2023-11,2023-11-30,2022-12-02,ACTUAL,2022-12-02,2022-09-12,ACTUAL,2022-09-12,,INTERVENTIONAL,,All patients randomized set included all patients in the enrolled set who were randomized to study medication.,A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD,"A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine Over 24 Weeks (With a 48-week Safety Subset) in Subjects With Moderate to Severe COPD",COMPLETED,,PHASE3,763.0,ACTUAL,Verona Pharma plc,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 16:32:11.32067,2024-10-16 16:32:11.32067,INDUSTRY,,,,,,,2022,1.0
NCT04504708,,2020-07-25,,,2022-10-19,2020-08-05,2020-08-07,ACTUAL,,,,,,,2022-10-19,2022-10-21,ACTUAL,2021-02-17,ACTUAL,2021-02-17,2022-10,2022-10-31,2022-07-08,ACTUAL,2022-07-08,2022-07-08,ACTUAL,2022-07-08,,INTERVENTIONAL,,,Dose-Escalation and Dose-Expansion Study of ZX-101A in Patients With Relapsed/Resistant or Refractory Advanced Hematologic Malignancies,"A Phase 1/2a, Dose-Escalation and Dose-Expansion Study of ZX-101A in Patients With Relapsed/Resistant or Refractory Advanced Hematologic Malignancies",TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,"Hangzhou Zenshine Pharmaceuticals Co., Ltd.",,5.0,,Study terminated early due to business decision.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,INDUSTRY,,,,,,,2022,0.0
NCT00390793,,2006-10-18,,,2024-02-06,2006-10-19,2006-10-20,ESTIMATED,,,,,,,2024-02-06,2024-02-07,ACTUAL,2006-09-28,ACTUAL,2006-09-28,2024-01,2024-01-31,2024-02-02,ACTUAL,2024-02-02,2024-02-02,ACTUAL,2024-02-02,,INTERVENTIONAL,,,Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia.,Phase II Study of Combination of Hyper-CVAD and Dasatinib in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL),COMPLETED,,PHASE2,107.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,OTHER,,,,,,,2024,1.0
NCT00005044,,2000-04-06,2017-10-02,,2022-05-23,2003-01-26,2003-01-27,ESTIMATED,2017-10-02,2017-10-31,ACTUAL,,,,2022-05-23,2022-06-15,ACTUAL,2000-02,ACTUAL,2000-02-29,2022-05,2022-05-31,2022-05-20,ACTUAL,2022-05-20,2012-09,ACTUAL,2012-09-30,,INTERVENTIONAL,,Eligible patients with follow-up data,Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer,A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and Radiation Therapy (RT) in Intermediate-Risk Prostate Cancer,COMPLETED,,PHASE3,1579.0,ACTUAL,Radiation Therapy Oncology Group,The data monitoring committee decided in June 2012 after the first interim analysis that the trial should be reported early due to the low number of events.,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 08:48:18.10378,2024-10-15 08:48:18.10378,NETWORK,,,,,,,2022,1.0
NCT01964430,,2013-10-14,2019-12-17,,2023-06-13,2013-10-14,2013-10-17,ESTIMATED,2019-12-17,2020-01-06,ACTUAL,,,,2023-06-13,2023-06-28,ACTUAL,2014-03-28,ACTUAL,2014-03-28,2023-06,2023-06-30,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,apact,The Intent-to-treat (ITT) population consisted of all randomized participants regardless of whether the participant received any investigational product (IP) or had any efficacy assessments collected.,Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the Apact Study),"A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma",COMPLETED,,PHASE3,866.0,ACTUAL,Celgene,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 08:48:18.10378,2024-10-15 08:48:18.10378,INDUSTRY,,,,,,,2022,1.0
NCT02150967,,2014-05-12,2022-02-22,,2023-06-29,2014-05-27,2014-05-30,ESTIMATED,2022-06-22,2022-07-15,ACTUAL,,,,2023-06-29,2023-07-03,ACTUAL,2014-07-23,ACTUAL,2014-07-23,2023-06,2023-06-30,2022-02-07,ACTUAL,2022-02-07,2021-03-01,ACTUAL,2021-03-01,,INTERVENTIONAL,,"Full Analysis Set (FAS), defined as all subjects who had received at least 1 dose of infigratinib.","A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma","A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy",TERMINATED,,PHASE2,143.0,ACTUAL,"QED Therapeutics, Inc.",,1.0,,"The study was terminated early due to limited efficacy in Cohorts 2 and 3 (exploratory endpoints). Termination was not due to concerns about safety and had no impact on the primary efficacy analysis (ie, results reported for Cohort 1).",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,INDUSTRY,,,,,,,2022,0.0
NCT03513458,,2018-04-19,,,2021-05-12,2018-04-19,2018-05-01,ACTUAL,,,,,,,2021-05-12,2021-05-14,ACTUAL,2020-09,ESTIMATED,2020-09-30,2021-05,2021-05-31,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,LateAna,,Late Phase Administration Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation,Late Phase Administration Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,\[The risk of inhaled allergen challenge and anakinra treatment outweigh benefits to participants with allergic asthma due to the COVID-19 pandemic.,f,,,,t,t,f,,,,,,,,,NO,The investigators will not be sharing individual participant data (IPD) with other researchers.,2024-10-15 08:48:18.10378,2024-10-15 08:48:18.10378,OTHER,,,,,,,2021,0.0
NCT03889639,,2019-03-01,2022-12-07,2021-01-19,2023-03-07,2019-03-23,2019-03-26,ACTUAL,2023-03-07,2023-03-08,ACTUAL,,2023-03-08,ACTUAL,2023-03-07,2023-03-08,ACTUAL,2019-03-29,ACTUAL,2019-03-29,2023-03,2023-03-31,2020-01-02,ACTUAL,2020-01-02,2020-01-02,ACTUAL,2020-01-02,,INTERVENTIONAL,,"Baseline analysis was performed on randomized population that included any participant who had been allocated to a randomly assigned treatment, regardless of whether the treatment kit was used.",Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis,"A Phase 2b Dose-finding Study for SAR442168, a Bruton's Tyrosine Kinase Inhibitor, in Participants With Relapsing Multiple Sclerosis",COMPLETED,,PHASE2,130.0,ACTUAL,Sanofi,,8.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 16:32:11.32067,2024-10-16 16:32:11.32067,INDUSTRY,,,,,,,2020,1.0
NCT04329949,,2020-03-13,2023-09-07,,2023-10-26,2020-03-31,2020-04-01,ACTUAL,2023-10-26,2023-11-18,ACTUAL,,,,2023-10-26,2023-11-18,ACTUAL,2020-06-30,ACTUAL,2020-06-30,2023-10,2023-10-31,2022-03-25,ACTUAL,2022-03-25,2021-08-23,ACTUAL,2021-08-23,,INTERVENTIONAL,RELIANT,All enrolled patients,Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma,A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (RELIANT),TERMINATED,,PHASE3,43.0,ACTUAL,Corcept Therapeutics,"The independent data monitoring committee found no safety issues, however the observed response rate did not meet the predefined threshold for continuing the study. The study was terminated by the Sponsor.",1.0,,"The independent data monitoring committee found no safety issues, however the observed response rate did not meet the predefined threshold for continuing the study. The study was terminated by the Sponsor.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,INDUSTRY,,,,,,,2022,0.0
NCT06124924,,2023-11-03,,,2024-08-21,2023-11-03,2023-11-09,ACTUAL,,,,,,,2024-08-21,2024-08-23,ACTUAL,2024-04-01,ACTUAL,2024-04-01,2024-08,2024-08-31,2024-08-16,ACTUAL,2024-08-16,2024-08-16,ACTUAL,2024-08-16,,INTERVENTIONAL,,,SGLT2 Inhibitors After Acute Kidney Injury With Indications Pilot,SGLT2 Inhibitors After Acute Kidney Injury With Indications Pilot,TERMINATED,,EARLY_PHASE1,1.0,ACTUAL,University of Minnesota,,2.0,,Poor recruitment,f,,,,,t,f,,,f,,,,,,,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,OTHER,,,,,,,2024,0.0
NCT05849246,,2023-04-17,,,2024-08-18,2023-05-05,2023-05-08,ACTUAL,,,,,,,2024-08-18,2024-08-20,ACTUAL,2023-07-31,ACTUAL,2023-07-31,2024-08,2024-08-31,2023-12-22,ACTUAL,2023-12-22,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,,,The Study of Tusamitamab Ravtansine (IBI126) Combined With Sintilimab and Tusamitamab Ravtansine (IBI126) Combined With Sintilimab Plus Platinum-based Chemotherapy and Pemetrexed in Subjects With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC),"Open-label, Phase 2 Study of Tusamitamab Ravtansine (IBI126) Combined With Sintilimab and Tusamitamab Ravtansine (IBI126) Combined With Sintilimab Plus Platinum-based Chemotherapy and Pemetrexed in Subjects With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)",TERMINATED,,PHASE2,4.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,3.0,,"strategy terminates development, the decision is not due to any safety-related issues",f,,,,f,f,f,,,,,,,,,,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,INDUSTRY,,,,,,,2023,0.0
NCT03338010,,2017-11-07,2021-03-15,,2021-05-03,2017-11-07,2017-11-09,ACTUAL,2021-05-03,2021-05-25,ACTUAL,,,,2021-05-03,2021-05-25,ACTUAL,2018-03-22,ACTUAL,2018-03-22,2021-05,2021-05-31,2020-03-18,ACTUAL,2020-03-18,2020-03-18,ACTUAL,2020-03-18,,INTERVENTIONAL,,All randomized participants who received at least one dose of study drug.,A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 2 Diabetes Mellitus,"A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus® in Adult Chinese Patients With Type 2 Diabetes Mellitus",COMPLETED,,PHASE3,536.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 08:48:18.10378,2024-10-15 08:48:18.10378,INDUSTRY,,,,,,,2020,1.0
NCT03791060,,2018-12-21,2022-07-13,,2024-05-09,2018-12-31,2019-01-02,ACTUAL,2024-05-09,2024-05-17,ACTUAL,,,,2024-05-09,2024-05-17,ACTUAL,2019-04-03,ACTUAL,2019-04-03,2024-05,2024-05-31,2021-04-10,ACTUAL,2021-04-10,2021-01-17,ACTUAL,2021-01-17,,INTERVENTIONAL,,Patient characteristics and demographic data will be presented using descriptive statistics.,Secukinumab for NLD (Cosentyx) in Patients With Necrobiosis Lipoidica Diabeticorum (NLD),An Open-label Proof of Concept Study Regarding the Use of Secukinumab (Cosentyx) in Patients With Necrobiosis Lipoidica Diabeticorum (NLD),TERMINATED,,PHASE2,4.0,ACTUAL,Beth Israel Deaconess Medical Center,,1.0,,Study halted prematurely due COVID-19 pandemic and did not resume; participants are no longer being examined or receiving intervention.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,OTHER,,,,,,,2021,0.0
NCT05226390,,2022-01-31,,,2024-01-19,2022-02-04,2022-02-07,ACTUAL,,,,,,,2024-01-19,2024-01-23,ACTUAL,2022-02-24,ACTUAL,2022-02-24,2024-01,2024-01-31,2023-11-21,ACTUAL,2023-11-21,2023-11-21,ACTUAL,2023-11-21,,INTERVENTIONAL,,,"Safety, Reactogenicity and Immunogenicity of a Novel MVA-SARS-2-ST Vaccine Candidate","Safety, Reactogenicity and Immunogenicity of a Novel MVA-SARS-2-ST Vaccine Candidate Administered as Inhalation Boost in SARS-CoV-2 Immunized Adults - Phase I Study",TERMINATED,,PHASE1,23.0,ACTUAL,Hannover Medical School,,1.0,,cohort could not be recruited,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 16:32:11.32067,2024-10-16 16:32:11.32067,OTHER,,,,,,,2023,0.0
NCT04125810,,2019-08-30,,,2020-03-24,2019-10-11,2019-10-14,ACTUAL,,,,,,,2020-03-24,2020-03-25,ACTUAL,2019-09-02,ACTUAL,2019-09-02,2020-03,2020-03-31,2020-02-07,ACTUAL,2020-02-07,2020-02-07,ACTUAL,2020-02-07,,INTERVENTIONAL,,,A Study to Assess the Safety and Efficacy of Probiotic to Modulate Psychological Stress,"A Randomized, Triple-blind, Placebo-controlled, Parallel-groups Clinical Trial to Assess the Safety and Efficacy of Lactobacillus Paracasei (Lpc-37) to Modulate Psychological Stress",COMPLETED,,PHASE2,190.0,ACTUAL,Danisco,,2.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,INDUSTRY,,,,,,,2020,0.0
NCT04722809,,2021-01-20,,,2024-08-23,2021-01-20,2021-01-25,ACTUAL,,,,,,,2024-08-23,2024-08-26,ACTUAL,2022-05-25,ACTUAL,2022-05-25,2024-08,2024-08-31,2022-08-31,ACTUAL,2022-08-31,2022-08-31,ACTUAL,2022-08-31,,INTERVENTIONAL,Botox,,Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology,Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology,TERMINATED,,PHASE3,1.0,ACTUAL,Centre Hospitalier Universitaire Dijon,,1.0,,"Difficulties in recruiting patients, compounded by problems extracting data from the device used in the study.",f,,,,,f,f,,,,,,,,,,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,OTHER,,,,,,,2022,0.0
NCT04069936,,2019-08-16,,,2022-07-28,2019-08-23,2019-08-28,ACTUAL,,,,,,,2022-07-28,2022-08-02,ACTUAL,2019-10-15,ACTUAL,2019-10-15,2022-07,2022-07-31,2021-11-30,ACTUAL,2021-11-30,2021-10-28,ACTUAL,2021-10-28,,INTERVENTIONAL,,,Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC,"A Phase 2a, Open-Label, Multi-Center Study to Assess the Efficacy and Safety of Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Subjects With Locally Advanced and Unresectable or Metastatic NSCLC Previously Treated With Anti-PD-1",TERMINATED,,PHASE2,19.0,ACTUAL,WindMIL Therapeutics,,1.0,,Resourcing,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 16:32:11.32067,2024-10-16 16:32:11.32067,INDUSTRY,,,,,,,2021,0.0
NCT03928015,,2019-04-09,,,2022-07-27,2019-04-24,2019-04-25,ACTUAL,,,,,,,2022-07-27,2022-07-28,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2022-07,2022-07-31,2021-06-29,ACTUAL,2021-06-29,2021-06-29,ACTUAL,2021-06-29,,INTERVENTIONAL,,,Evaluation of Dronabinol For Acute Pain Following Traumatic Injury,A Single Centre Randomized Controlled Trial To Evaluate Dronabinol For Acute Pain Management In Adults With Traumatic Injury,WITHDRAWN,,PHASE2,0.0,ACTUAL,CommonSpirit Health,,2.0,,"This trial did not enroll subjects. After initial approval we procured an appropriate placebo. Before IRB the amendment was approved, the COVID-19 pandemic placed a hold on all non-essential research activity at the enrolling hospital.",f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,OTHER,,,,,,,2021,0.0
NCT03883893,,2019-03-19,,,2022-03-24,2019-03-19,2019-03-21,ACTUAL,,,,,,,2022-03-24,2022-04-05,ACTUAL,2021-12,ESTIMATED,2021-12-31,2022-03,2022-03-31,2023-04,ESTIMATED,2023-04-30,2022-10,ESTIMATED,2022-10-31,,INTERVENTIONAL,,,IV Acetaminophen and Post-Tonsillectomy Pain,Randomized Prospective Study Investigating the Analgesic Efficacy of Intravenous Acetaminophen in Reducing Post-Tonsillectomy Pain in Pediatric Patients,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Children's Hospital Medical Center, Cincinnati",,2.0,,Mentor for PI left institution. Study was not renewed.,f,,,,f,f,f,,,f,,,,,,,,2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,OTHER,,,,,,,2023,0.0
NCT03708536,,2018-10-13,,,2021-03-04,2018-10-16,2018-10-17,ACTUAL,,,,,,,2021-03-04,2021-03-08,ACTUAL,2018-11,ESTIMATED,2018-11-30,2018-10,2018-10-31,2022-11,ESTIMATED,2022-11-30,2021-11,ESTIMATED,2021-11-30,,INTERVENTIONAL,,,Bevacizumab Plus Capecitabin vs S-1 as Maintenance Treatment Following First-line Chemotherapy in the Patients With Advanced Colorectal Adenocarcinoma,Bevacizumab Plus Capecitabin vs S-1 as Maintenance Treatment Following First-line Chemotherapy in the Patients With Advanced Colorectal Adenocarcinoma. A Phase 3 Randomised Controlled Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,Fujian Cancer Hospital,,2.0,,There are no fund to support,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 16:32:11.32067,2024-10-16 16:32:11.32067,OTHER_GOV,,,,,,,2022,0.0
NCT04426357,,2020-06-08,,,2021-01-13,2020-06-08,2020-06-11,ACTUAL,,,,,,,2021-01-13,2021-01-15,ACTUAL,2020-07-03,ACTUAL,2020-07-03,2021-01,2021-01-31,2020-11-12,ACTUAL,2020-11-12,2020-11-12,ACTUAL,2020-11-12,,INTERVENTIONAL,,,A Study to Evaluate the Effect of Renal Impairment on JNJ-64417184 and Its Two Minor Metabolites JNJ-68294291 and JNJ-65201526 in Adult Participants,"A Single-dose, Open-label, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64417184 and Its Two Minor Metabolites JNJ-68294291 and JNJ-65201526 in Adult Participants",TERMINATED,,PHASE1,6.0,ACTUAL,"Janssen Pharmaceutica N.V., Belgium",,2.0,,company decision,f,,,,f,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,INDUSTRY,,,,,,,2020,0.0
NCT04332549,,2020-03-26,,,2020-05-28,2020-04-01,2020-04-02,ACTUAL,,,,,,,2020-05-28,2020-06-01,ACTUAL,2020-04-27,ESTIMATED,2020-04-27,2020-05,2020-05-31,2021-01-28,ESTIMATED,2021-01-28,2021-01-28,ESTIMATED,2021-01-28,,INTERVENTIONAL,,,To Assess the Bioavailability and Safety of Paclitaxel Injection Concentrate for Suspension in Subjects With Locally Recurrent or Metastatic Breast Cancer,"A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study of Paclitaxel Injection Concentrate for Suspension (PICS) in Subjects With Locally Recurrent or Metastatic Breast Cancer.",WITHDRAWN,,PHASE1,0.0,ACTUAL,Sun Pharma Advanced Research Company Limited,,2.0,,"After meeting with the FDA, SPARC concludes a BE study will not be required",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,INDUSTRY,,,,,,,2021,0.0
NCT05017103,,2021-08-17,,,2024-08-19,2021-08-19,2021-08-23,ACTUAL,,,,,,,2024-08-19,2024-08-21,ACTUAL,2021-07-13,ACTUAL,2021-07-13,2024-08,2024-08-31,2024-02-20,ACTUAL,2024-02-20,2024-02-20,ACTUAL,2024-02-20,,INTERVENTIONAL,,,"Sintilimab for the Treatment of Locally Advanced, Metastatic, Recurrent, or Unresectable Undifferentiated Pleomorphic Sarcoma, SiARa Cancer Study",A Phase II Clinical Trial Evaluating the Efficacy and Safety of Sintilimab for Advanced Rare Cancers (SiARa Cancer Study) - Undifferentiated Pleomorphic Sarcoma (SiARa-UPS),TERMINATED,,PHASE2,6.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,"All subjects have finished their final visits and follow-up,",,,,,t,t,f,,,,,,,,,,,2024-10-17 04:03:03.505017,2024-10-17 04:03:03.505017,OTHER,,,,,,,2024,0.0
NCT02404506,,2015-03-26,,,2021-09-27,2015-03-30,2015-03-31,ESTIMATED,,,,,,,2021-09-27,2021-09-29,ACTUAL,2015-08-17,ACTUAL,2015-08-17,2021-09,2021-09-30,2021-07-22,ACTUAL,2021-07-22,2020-12-30,ACTUAL,2020-12-30,,INTERVENTIONAL,,,Eribulin as 1st Line Treatment in Elderly Patients With Advanced Breast Cancer,Eribulin as 1st Line Treatment in Elderly Patients (≥ 70 Years) With Advanced Breast Cancer: a Multicenter Phase II Trial,TERMINATED,,PHASE2,78.0,ACTUAL,Swiss Group for Clinical Cancer Research,,1.0,,"The trial was prematurely terminated as of 22.07.2021 as per SAKK board decision board decision from 14th of November 2020. The trial was terminated after the primary endpoint was analyzed, which was the case end of December 2020.",f,,,,t,,,,,,,,,,,NO,,2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,OTHER,,,,,,,2021,0.0
NCT03755154,,2018-11-13,,,2024-10-14,2018-11-26,2018-11-27,ACTUAL,,,,,,,2024-10-14,2024-10-16,ESTIMATED,2019-07-17,ACTUAL,2019-07-17,2024-10,2024-10-31,2023-11-06,ACTUAL,2023-11-06,2023-11-06,ACTUAL,2023-11-06,,INTERVENTIONAL,,,"Study of a New Intravenous Drug, Called S65487, in Patients With Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia","Phase I, Open Label, Non-randomised, Non-comparative, Multi-center Study, Evaluating S65487, a Bcl-2 Inhibitor Intravenously Administered, in Patients With Relapsed or Refractory Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia",TERMINATED,,PHASE1,60.0,ACTUAL,Servier,,2.0,,The study was prematurely terminated on 14th March 2023 for strategic considerations due to the limited efficacy seen with this treatment in monotherapy. This decision was not based on any safety concerns.,f,,,,f,f,f,,,,,,After Marketing Authorisation in EEA or US if the study is used for the approval.,Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.,https://clinicaltrials.servier.com/,YES,"Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.",2024-10-17 04:21:56.486553,2024-10-17 04:21:56.486553,INDUSTRY,,,,,,,2023,0.0
NCT04984330,,2021-07-29,,,2022-11-11,2021-07-29,2021-07-30,ACTUAL,,,,,,,2022-11-11,2022-11-17,ACTUAL,2021-12,ESTIMATED,2021-12-31,2022-11,2022-11-30,2024-06,ESTIMATED,2024-06-30,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,STARR,,Selinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory Disease,Selinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory Disease,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Weill Medical College of Cornell University,,1.0,,Funding withdrawn,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:48:18.10378,2024-10-15 08:48:18.10378,OTHER,,,,,,,2024,0.0
NCT03722966,,2018-10-24,2024-01-10,,2024-01-10,2018-10-25,2018-10-29,ACTUAL,2024-01-10,2024-02-06,ACTUAL,,,,2024-01-10,2024-02-06,ACTUAL,2020-01-07,ACTUAL,2020-01-07,2024-01,2024-01-31,2022-02-07,ACTUAL,2022-02-07,2022-02-07,ACTUAL,2022-02-07,,INTERVENTIONAL,,,Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO),A Comparison of the Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy Versus Varenicline Alone for Smoking Cessation: a Pilot Study,TERMINATED,,PHASE2,34.0,ACTUAL,University of Oklahoma,The study was discontinued early due to the recall of varenicline.,4.0,,"Following the Chantix recall, Pfizer stopped providing medication for the study and and new study enrollments were discontinued.",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 08:48:18.10378,2024-10-15 08:48:18.10378,OTHER,,,,,,,2022,0.0
NCT02546999,,2015-09-09,,,2022-01-10,2015-09-09,2015-09-11,ESTIMATED,,,,,,,2022-01-10,2022-01-11,ACTUAL,2015-09,,2015-09-30,2022-01,2022-01-31,2021-10-15,ACTUAL,2021-10-15,2021-10-15,ACTUAL,2021-10-15,,INTERVENTIONAL,WE,,Does Botulinum Toxin A Make Walking Easier in Children With Cerebral Palsy?,Does Botulinum Toxin A Make Walking Easier in Children With Cerebral Palsy?,COMPLETED,,PHASE4,61.0,ACTUAL,St. Olavs Hospital,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,OTHER,,,,,,,2021,0.0
NCT04331899,,2020-03-27,2021-04-08,,2021-11-24,2020-04-01,2020-04-02,ACTUAL,2021-04-19,2021-04-22,ACTUAL,,,,2021-11-24,2021-11-30,ACTUAL,2020-04-25,ACTUAL,2020-04-25,2021-11,2021-11-30,2021-05-06,ACTUAL,2021-05-06,2020-08-14,ACTUAL,2020-08-14,,INTERVENTIONAL,COVID-Lambda,,Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19,"A Phase 2 Randomized, Single-Blind Study of a Single Dose of Peginterferon Lambda-1a (Lambda) Compared With Placebo in Outpatients With Mild COVID-19",COMPLETED,,PHASE2,120.0,ACTUAL,Stanford University,,2.0,,,f,,,,t,t,f,,,,,,The datasets generated and analyzed during the current study are permanently available in the Stanford Digital Repository,Full access,https://purl.stanford.edu/hc972ys6733,YES,Sharing of generated and analyzed datasets.,2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,OTHER,,,,,,,2021,1.0
NCT02899299,,2016-08-31,2021-03-24,,2024-04-24,2016-09-08,2016-09-14,ESTIMATED,2021-03-24,2021-04-14,ACTUAL,,,,2024-04-24,2024-05-21,ACTUAL,2016-11-29,ACTUAL,2016-11-29,2024-04,2024-04-30,2023-04-28,ACTUAL,2023-04-28,2020-03-25,ACTUAL,2020-03-25,,INTERVENTIONAL,CheckMate743,,Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients,"A Phase III, Randomized, Open Label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma",COMPLETED,,PHASE3,605.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,t,,,,t,,,,,,,,,,,,,2024-10-15 08:48:18.10378,2024-10-15 08:48:18.10378,INDUSTRY,,NCT02475382,NO_LONGER_AVAILABLE,,,,2023,1.0
NCT02200770,,2014-07-16,2019-10-24,,2021-11-03,2014-07-24,2014-07-25,ESTIMATED,2019-12-10,2019-12-26,ACTUAL,,,,2021-11-03,2021-12-03,ACTUAL,2015-04-01,ACTUAL,2015-04-01,2021-11,2021-11-30,2020-11-06,ACTUAL,2020-11-06,2018-10-26,ACTUAL,2018-10-26,,INTERVENTIONAL,,"The Intent-to-treat (ITT) population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment.",N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders,"A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.",COMPLETED,,PHASE2/PHASE3,231.0,ACTUAL,MedImmune LLC,"In the safety follow-up period (SFP), only 1 participant from 'Placebo/Inebilizumab' arm rolled over to SFP and no participant from 'Inebilizumab /Inebilizumab' arm rolled over to SFP. For EudraCT result posting, a study period with any one of the arm with zero participants started is not acceptable (EudraCT limitation). Therefore, not included SFP in 'Participant Flow' section to keep the data consistent across registry portals.",2.0,,,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared",2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,INDUSTRY,,,,,,,2020,1.0
NCT02446145,,2015-02-11,,,2024-03-27,2015-05-13,2015-05-18,ESTIMATED,,,,,,,2024-03-27,2024-03-29,ACTUAL,2015-05,,2015-05-31,2024-03,2024-03-31,2023-01-25,ACTUAL,2023-01-25,2020-12-26,ACTUAL,2020-12-26,,INTERVENTIONAL,DELTA,,A Randomized Placebo-controlled Phase 2 Study of Decitabine With or Without Eltrombopag in AML Patients,A Randomized Placebo-controlled Phase 2 Study of Decitabine With or Without Eltrombopag in AML Patients ≥65 Years of Age Not Eligible for Intensive Chemotherapy,TERMINATED,,PHASE2,132.0,ACTUAL,Technische Universität Dresden,,2.0,,"Due to COVID-19 pandemia, recruitment was insufficient to reach required sample size in an acceptable time line. Furthermore, new drugs have recently been licensed resulting in alternative treatment regimens with a better prognosis.",f,,,,t,,,,,,,,,,,,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,OTHER,,,,,,,2023,0.0
NCT04156204,,2019-11-01,,,2020-11-30,2019-11-05,2019-11-07,ACTUAL,,,,,,,2020-11-30,2020-12-02,ACTUAL,2019-11-20,ACTUAL,2019-11-20,2020-11,2020-11-30,2020-11-27,ACTUAL,2020-11-27,2020-11-27,ACTUAL,2020-11-27,,INTERVENTIONAL,,,Immunosuppressant Medication Dosed Daily After Kidney Transplant,Kidney Immunosuppression Dosed Daily Only (KIDDO) - A Pilot Study,TERMINATED,,EARLY_PHASE1,1.0,ACTUAL,"University of Colorado, Denver",,1.0,,Discontinuation of study due to site staffing and resources available to conduct the study,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,OTHER,,,,,,,2020,0.0
NCT04338074,,2020-04-06,2021-04-21,,2021-05-11,2020-04-06,2020-04-08,ACTUAL,2021-05-11,2021-05-13,ACTUAL,,,,2021-05-11,2021-05-13,ACTUAL,2020-06-01,ACTUAL,2020-06-01,2021-05,2021-05-31,2021-04-21,ACTUAL,2021-04-21,2021-04-21,ACTUAL,2021-04-21,,INTERVENTIONAL,TCOutpatient,,TXA and Corona Virus 2019 (COVID19) in Outpatients,Exploratory Studies of the Effect of Tranexamic Acid Treatment on the Progression of COVID19 in Outpatients,TERMINATED,,PHASE2,5.0,ACTUAL,University of Alabama at Birmingham,,2.0,,Lack of recruitment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:48:18.10378,2024-10-15 08:48:18.10378,OTHER,,,,,,,2021,0.0
NCT04430348,,2020-06-04,2023-08-16,,2023-08-16,2020-06-10,2020-06-12,ACTUAL,2023-08-16,2024-03-12,ACTUAL,,,,2023-08-16,2024-03-12,ACTUAL,2020-06-04,ACTUAL,2020-06-04,2023-08,2023-08-31,2023-06-15,ACTUAL,2023-06-15,2022-11-02,ACTUAL,2022-11-02,,INTERVENTIONAL,,,PTX-35 in Patients With Advanced Solid Tumors,"PTX35-001 A Phase I, First-in-Human, Dose-Escalation Study to Evaluate the Safety of the Monoclonal Antibody PTX-35 in Patients With Advanced Solid Tumors Refractory to Standard of Care",TERMINATED,,PHASE1,22.0,ACTUAL,Heat Biologics,,6.0,,Absence of immunological response,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,INDUSTRY,,,,,,,2023,0.0
NCT03375606,,2017-12-13,,,2021-06-02,2017-12-15,2017-12-18,ACTUAL,,,,,,,2021-06-02,2021-06-03,ACTUAL,2018-01-10,ACTUAL,2018-01-10,2021-06,2021-06-30,2020-06-22,ACTUAL,2020-06-22,2020-06-22,ACTUAL,2020-06-22,,INTERVENTIONAL,,,Assessing the Safety and Tolerability of CSL730 in Healthy Caucasian and Japanese Adults,"A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous CSL730 in Healthy Caucasian and Japanese Subjects",TERMINATED,,PHASE1,26.0,ACTUAL,CSL Behring,,2.0,,The Sponsor decided to terminate this study in favor of development of subcutaneous administration.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 08:48:18.10378,2024-10-15 08:48:18.10378,INDUSTRY,,,,,,,2020,0.0
NCT03719612,,2018-09-28,2020-12-11,,2021-01-07,2018-10-23,2018-10-25,ACTUAL,2020-12-11,2021-01-07,ACTUAL,,,,2021-01-07,2021-01-28,ACTUAL,2018-12-28,ACTUAL,2018-12-28,2019-11,2019-11-30,2020-01-09,ACTUAL,2020-01-09,2020-01-09,ACTUAL,2020-01-09,,INTERVENTIONAL,BENEFIT2,Baseline data are calculated based on Safety Population,DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY,"A Phase III, Open-Label, Multicenter Trial to Evaluate Ejection Fraction, End-Diastolic and End-Systolic Volumes, by Unenhanced and DEFINITY®-Enhanced 2D-Echo and Magnetic Resonance Imaging",COMPLETED,,PHASE3,160.0,ACTUAL,Lantheus Medical Imaging,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 08:48:18.10378,2024-10-15 08:48:18.10378,INDUSTRY,,,,,,,2020,1.0
NCT03610282,,2018-07-26,,,2020-02-19,2018-07-26,2018-08-01,ACTUAL,,,,,,,2020-02-19,2020-02-21,ACTUAL,2019-11,ESTIMATED,2019-11-30,2020-02,2020-02-29,2021-11,ESTIMATED,2021-11-30,2020-11,ESTIMATED,2020-11-30,,INTERVENTIONAL,,,EEG Study of IV Methylphenidate-Induced Emergence From Propofol Sedation,Electroencephalogram Study of Intravenous Methylphenidate-Induced Emergence From Propofol Sedation,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Massachusetts General Hospital,,2.0,,We have decided to withdraw the study prior to enrollment of the first participant in order to pursue other research studies.,,,,,f,t,f,,,,,,,,,,,2024-10-15 08:48:18.10378,2024-10-15 08:48:18.10378,OTHER,,,,,,,2021,0.0
NCT04142554,,2019-10-24,,,2020-11-02,2019-10-28,2019-10-29,ACTUAL,,,,,,,2020-11-02,2020-11-03,ACTUAL,2020-06-01,ESTIMATED,2020-06-01,2020-10,2020-10-31,2020-09-07,ACTUAL,2020-09-07,2020-09-07,ACTUAL,2020-09-07,,INTERVENTIONAL,LCCC1820,,Parsaclisib in Newly Diagnosed Stage I-IIIC Triple Negative or HER2+ Breast Cancer,Window of Opportunity Study of Parsaclisib in Subjects With Newly Diagnosed Stage I-IIIC Triple-Negative or HER2-Positive Breast Cancer,WITHDRAWN,,PHASE1,0.0,ACTUAL,UNC Lineberger Comprehensive Cancer Center,,1.0,,Funding withdrawn from funding source.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,OTHER,,,,,,,2020,0.0
NCT04364763,,2020-04-20,2023-01-30,,2023-03-28,2020-04-24,2020-04-28,ACTUAL,2023-03-28,2023-03-29,ACTUAL,,,,2023-03-28,2023-03-29,ACTUAL,2020-08-05,ACTUAL,2020-08-05,2023-03,2023-03-31,2021-09-30,ACTUAL,2021-09-30,2021-09-02,ACTUAL,2021-09-02,,INTERVENTIONAL,,,A Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study),"A Phase 2, Randomized, Placebo-Controlled Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study)",TERMINATED,,PHASE2,42.0,ACTUAL,"Renibus Therapeutics, Inc.",,2.0,,Enrollment feasibility,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 16:32:11.32067,2024-10-16 16:32:11.32067,INDUSTRY,,,,,,,2021,0.0
NCT03545243,,2018-04-24,,,2020-09-23,2018-05-22,2018-06-04,ACTUAL,,,,,,,2020-09-23,2020-09-28,ACTUAL,2018-04-23,ACTUAL,2018-04-23,2020-09,2020-09-30,2020-09-22,ACTUAL,2020-09-22,2020-03-08,ACTUAL,2020-03-08,,INTERVENTIONAL,,,PPI and Microbiome in Healthy Volunteers and Functional Dyspepsia,Effect of Proton Pump Inhibitors on the Duodenal Microbiome in Healthy Volunteers and Functional Dyspepsia Patients,COMPLETED,,PHASE4,79.0,ACTUAL,Universitaire Ziekenhuizen KU Leuven,,3.0,,,f,,,,f,f,f,,,f,,,,,,UNDECIDED,,2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,OTHER,,,,,,,2020,1.0
NCT03482011,,2018-03-23,2020-08-31,2020-03-06,2020-08-31,2018-03-23,2018-03-29,ACTUAL,2020-08-31,2020-09-25,ACTUAL,2020-03-06,2020-03-11,ACTUAL,2020-08-31,2020-09-25,ACTUAL,2018-04-24,ACTUAL,2018-04-24,2020-02-01,2020-02-01,2020-01-16,ACTUAL,2020-01-16,2019-03-21,ACTUAL,2019-03-21,,INTERVENTIONAL,OASIS-1,All randomized participants.,A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis,"A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Withdrawal Maintenance Dosing Period to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-1",COMPLETED,,PHASE3,530.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,INDUSTRY,,,,,,,2020,1.0
NCT03988842,,2019-05-24,2021-03-19,,2021-05-18,2019-06-13,2019-06-18,ACTUAL,2021-04-26,2021-05-18,ACTUAL,,,,2021-05-18,2021-06-11,ACTUAL,2019-07-25,ACTUAL,2019-07-25,2021-04,2021-04-30,2020-04-05,ACTUAL,2020-04-05,2020-04-05,ACTUAL,2020-04-05,,INTERVENTIONAL,SAFE-LYSE,The study was closed prematurely due to covid-19. Unblinding was not done and analysis was not performed.,Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pulmonary Embolism,Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pulmonary Embolism,TERMINATED,,PHASE4,4.0,ACTUAL,Cedars-Sinai Medical Center,Enrollment was held and study closed prematurely due to COVID-19 pandemic. We were otherwise hopeful to enroll and complete all assessments for this study.,2.0,,COVID-19 pandemic,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,OTHER,,,,,,,2020,0.0
NCT03829501,,2019-01-17,,,2024-10-14,2019-02-01,2019-02-04,ACTUAL,,,,,,,2024-10-14,2024-10-16,ESTIMATED,2019-01-28,ACTUAL,2019-01-28,2024-10,2024-10-31,2024-10-03,ACTUAL,2024-10-03,2024-10-03,ACTUAL,2024-10-03,,INTERVENTIONAL,,,Safety and Efficacy of KY1044 and Atezolizumab in Advanced Cancer,"A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of KY1044 As Single Agent and in Combination with Anti-PD-L1 (atezolizumab) in Adult Patients with Selected Advanced Malignancies",TERMINATED,,PHASE1/PHASE2,222.0,ACTUAL,Kymab Limited,,4.0,,Early discontinuation based on strategic sponsor decision not driven by any safety concerns.,f,,,,t,t,f,,,f,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at https://vivli.org",2024-10-17 04:21:56.486553,2024-10-17 04:21:56.486553,INDUSTRY,,,,,,,2024,0.0
NCT03361501,,2017-11-21,,,2020-08-10,2017-11-28,2017-12-05,ACTUAL,,,,,,,2020-08-10,2020-08-12,ACTUAL,2018-02-01,ACTUAL,2018-02-01,2020-08,2020-08-31,2020-01-09,ACTUAL,2020-01-09,2019-09-24,ACTUAL,2019-09-24,,INTERVENTIONAL,TRILOGY 2,,A Phase 3 STudy of CaPRe in LOwering Very hiGh TriglYcerides (TRILOGY 2),"A Phase 3, Multi-center, Multi-national, Placebo-controlled, Randomized, Double-blind 26 Week Study to Assess the Safety and Efficacy of CaPre® in Patients With Severe Hypertriglyceridemia",COMPLETED,,PHASE3,278.0,ACTUAL,Acasti Pharma Inc.,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,INDUSTRY,,,,,,,2020,1.0
NCT03271489,,2017-08-31,,,2024-07-17,2017-08-31,2017-09-05,ACTUAL,,,,,,,2024-07-17,2024-07-19,ACTUAL,2017-01-04,ACTUAL,2017-01-04,2024-07,2024-07-31,2024-06-28,ACTUAL,2024-06-28,2024-06-28,ACTUAL,2024-06-28,,INTERVENTIONAL,,,Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women,A Phase 3b Study to Evaluate the Long-Term Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women,COMPLETED,,PHASE3,478.0,ACTUAL,AbbVie,,2.0,,,f,,,,f,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.",2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,INDUSTRY,,,,,,,2024,1.0
NCT03217812,,2017-07-13,,,2024-04-24,2017-07-13,2017-07-14,ACTUAL,,,,,,,2024-04-24,2024-04-25,ACTUAL,2017-11-23,ACTUAL,2017-11-23,2024-04,2024-04-30,2024-03-08,ACTUAL,2024-03-08,2020-07-02,ACTUAL,2020-07-02,,INTERVENTIONAL,,,"A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region)","A Phase 3, Multicenter, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region)",COMPLETED,,PHASE3,220.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,INDUSTRY,,,,,,,2024,1.0
NCT02824575,,2016-06-28,,,2022-03-23,2016-07-01,2016-07-06,ESTIMATED,,,,,,,2022-03-23,2022-04-04,ACTUAL,2016-07,,2016-07-31,2022-03,2022-03-31,2021-12-27,ACTUAL,2021-12-27,2021-12-27,ACTUAL,2021-12-27,,INTERVENTIONAL,,,Rebastinib Plus Antitubulin Therapy With Paclitaxel or Eribulin in Metastatic Breast Cancer,Phase Ib Study of Rebastinib Plus Antitubulin Therapy With Paclitaxel or Eribulin in Patients With Metastatic Breast Cancer,TERMINATED,,PHASE1,28.0,ACTUAL,Montefiore Medical Center,,2.0,,"Unfortunately, Deciphera management decided to not move forward with the rebastinib program and are terminating early.",f,,,,t,,,,,,,,,,,NO,,2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,OTHER,,,,,,,2021,0.0
NCT05367661,,2022-04-05,,,2023-11-01,2022-05-05,2022-05-10,ACTUAL,,,,,,,2023-11-01,2023-11-03,ACTUAL,2022-04-08,ACTUAL,2022-04-08,2023-11,2023-11-30,2023-04-19,ACTUAL,2023-04-19,2023-04-19,ACTUAL,2023-04-19,,INTERVENTIONAL,,,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CHK-336 in Healthy Volunteers","A Phase 1, Single-Center, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CHK-336 in Healthy Volunteers",TERMINATED,,PHASE1,88.0,ACTUAL,"Chinook Therapeutics, Inc.",,4.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,INDUSTRY,,,,,,,2023,0.0
NCT04205539,,2019-12-17,,,2022-09-26,2019-12-18,2019-12-19,ACTUAL,,,,,,,2022-09-26,2022-09-28,ACTUAL,2021-12-10,ESTIMATED,2021-12-10,2022-09,2022-09-30,2023-12,ESTIMATED,2023-12-31,2022-12-10,ESTIMATED,2022-12-10,,INTERVENTIONAL,,,Lymphatic System Health in Alzheimer's Disease,Lymphatic System Health in Alzheimer's Disease,WITHDRAWN,,PHASE1,0.0,ACTUAL,Neurological Associates of West Los Angeles,,1.0,,Pending COVID-19 pandemic,f,,,,f,t,f,,,t,,,,,,NO,Data from this study will not be made publicly available due to ethical and privacy concerns. Anonymized data will be available upon reasonable request from any qualified investigator.,2024-10-16 16:32:11.32067,2024-10-16 16:32:11.32067,OTHER,,,,,,,2023,0.0
NCT04614636,,2020-10-29,,,2023-09-19,2020-11-03,2020-11-04,ACTUAL,,,,,,,2023-09-19,2023-09-21,ACTUAL,2020-10-17,ACTUAL,2020-10-17,2023-09,2023-09-30,2023-08-08,ACTUAL,2023-08-08,2023-07-13,ACTUAL,2023-07-13,,INTERVENTIONAL,,,FT538 in Subjects With Advanced Hematologic Malignancies,"A Phase I, Open-Label, Multicenter Study of FT538 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory Multiple Myeloma",TERMINATED,,PHASE1,42.0,ACTUAL,Fate Therapeutics,,3.0,,This study was terminated by the Sponsor.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,INDUSTRY,,,,,,,2023,0.0
NCT04452318,,2020-06-26,2022-09-29,,2023-04-20,2020-06-26,2020-06-30,ACTUAL,2023-04-20,2023-05-15,ACTUAL,,,,2023-04-20,2023-05-15,ACTUAL,2020-07-13,ACTUAL,2020-07-13,2023-04,2023-04-30,2021-10-04,ACTUAL,2021-10-04,2021-10-04,ACTUAL,2021-10-04,,INTERVENTIONAL,,,COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2",COMPLETED,,PHASE3,3303.0,ACTUAL,Regeneron Pharmaceuticals,,2.0,,,f,,,,t,t,f,,,,,,"Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.","Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency \[EMA\], Pharmaceuticals and Medical Devices Agency \[PMDA\], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).",https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,INDUSTRY,,,,,,,2021,1.0
NCT03572634,,2018-05-21,2020-11-19,,2023-11-07,2018-06-27,2018-06-28,ACTUAL,2021-01-12,2021-02-02,ACTUAL,,,,2023-11-07,2023-11-09,ACTUAL,2019-06-10,ACTUAL,2019-06-10,2023-11,2023-11-30,2020-01-21,ACTUAL,2020-01-21,2020-01-21,ACTUAL,2020-01-21,,INTERVENTIONAL,,,Phase 1/2 Study of TP-0903 (an Inhibitor of AXL Kinase) in Patients With Previously Treated CLL,"A Combined Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of TP-0903 in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)",TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,"Sumitomo Pharma America, Inc.",The study was stopped early (21 January 2020) due to low enrollment.,2.0,,"Given the extensive time projected to conclude the study hypothesis, it is no longer feasible to include this study of TP-0903.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,INDUSTRY,,,,,,,2020,0.0
NCT04247074,,2020-01-07,2023-05-23,2021-05-26,2023-08-09,2020-01-27,2020-01-29,ACTUAL,2023-08-09,2023-09-06,ACTUAL,,2023-09-06,ACTUAL,2023-08-09,2023-09-06,ACTUAL,2020-02-10,ACTUAL,2020-02-10,2023-06,2023-06-30,2021-02-26,ACTUAL,2021-02-26,2020-10-02,ACTUAL,2020-10-02,,INTERVENTIONAL,READY-3,,Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination",COMPLETED,,PHASE3,413.0,ACTUAL,Galderma R&D,,4.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,INDUSTRY,,,,,,,2021,1.0
NCT03943147,,2019-04-29,2022-09-16,2021-10-28,2022-09-16,2019-05-07,2019-05-09,ACTUAL,2022-09-16,2022-10-17,ACTUAL,2021-10-28,2021-11-02,ACTUAL,2022-09-16,2022-10-17,ACTUAL,2019-07-15,ACTUAL,2019-07-15,2022-09,2022-09-30,2021-09-17,ACTUAL,2021-09-17,2020-10-29,ACTUAL,2020-10-29,,INTERVENTIONAL,,Baseline analysis population for Open Label MMF includes all participants that did not meet randomization criteria in Part B. Open Label MMF + BMS-986165 includes the participant that met the randomization criteria in Part B.,An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis,"A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 With Background Treatment in Subjects With Lupus Nephritis",TERMINATED,,PHASE2,16.0,ACTUAL,Bristol-Myers Squibb,"Due to low enrollment, the Sponsor chose to terminate the study on 01-Jul-2021 and consequently there is limited data available from a single randomized participant. Due to lack of sufficient data, no formal statistical analyses of endpoints were conducted.",4.0,,Insufficient enrollment,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,INDUSTRY,,,,,,,2021,0.0
NCT04464629,,2020-07-06,,,2023-08-14,2020-07-08,2020-07-09,ACTUAL,,,,,,,2023-08-14,2023-08-16,ACTUAL,2020-07-14,ACTUAL,2020-07-14,2023-08,2023-08-31,2023-01-25,ACTUAL,2023-01-25,2023-01-25,ACTUAL,2023-01-25,,INTERVENTIONAL,,,Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment,"Assessing the Efficacy and Safety of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment",TERMINATED,,PHASE4,7.0,ACTUAL,Midwest Eye Institute,,2.0,,Poor enrollment,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,OTHER,,,,,,,2023,0.0
NCT05252520,,2022-02-16,,,2023-01-25,2022-02-16,2022-02-23,ACTUAL,,,,,,,2023-01-25,2023-01-27,ACTUAL,2023-05-01,ESTIMATED,2023-05-01,2023-01,2023-01-31,2023-11-20,ESTIMATED,2023-11-20,2023-11-20,ESTIMATED,2023-11-20,,INTERVENTIONAL,,,A Study of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants,"A Phase 1 Open-label Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants Following Subcutaneous Administration",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Janssen Research & Development, LLC",,1.0,,The development of bermekimab in Immunology is stopped,f,,,,f,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.",2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,INDUSTRY,,,,,,,2023,0.0
NCT01948297,,2013-08-26,,,2020-09-08,2013-09-18,2013-09-23,ESTIMATED,,,,,,,2020-09-08,2020-09-09,ACTUAL,2013-08,,2013-08-31,2020-09,2020-09-30,2020-06-26,ACTUAL,2020-06-26,2020-06-26,ACTUAL,2020-06-26,,INTERVENTIONAL,,,Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations,"A Phase I, Gene Alteration-based, Open Label, Multicenter Study of Oral Debio 1347 (CH5183284) in Patients With Advanced Solid Malignancies, Whose Tumours Have an Alteration of the FGFR 1, 2 or 3 Genes",TERMINATED,,PHASE1,77.0,ACTUAL,Debiopharm International SA,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,INDUSTRY,,,,,,,2020,0.0
NCT02967692,,2016-11-16,2023-06-26,2021-07-05,2024-10-10,2016-11-16,2016-11-18,ESTIMATED,2023-06-26,2023-07-24,ACTUAL,2021-07-05,2021-07-08,ACTUAL,2024-10-10,2024-10-15,ACTUAL,2017-02-17,ACTUAL,2017-02-17,2024-10,2024-10-31,2024-08-21,ACTUAL,2024-08-21,2020-08-11,ACTUAL,2020-08-11,,INTERVENTIONAL,COMBI-i,,"A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma","A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma",COMPLETED,,PHASE3,569.0,ACTUAL,Novartis,,4.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-17 04:21:56.486553,2024-10-17 04:21:56.486553,INDUSTRY,,,,,,,2024,1.0
NCT03262935,,2017-08-16,2023-06-30,,2023-09-28,2017-08-23,2017-08-25,ACTUAL,2023-09-28,2023-10-19,ACTUAL,,,,2023-09-28,2023-10-19,ACTUAL,2017-12-15,ACTUAL,2017-12-15,2023-06,2023-06-30,2022-06-30,ACTUAL,2022-06-30,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,TULIP,,SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer,"A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer",COMPLETED,,PHASE3,437.0,ACTUAL,Byondis B.V.,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,INDUSTRY,,,,,,,2022,1.0
NCT04545060,,2020-09-04,2022-09-06,,2022-10-12,2020-09-09,2020-09-10,ACTUAL,2022-10-12,2022-11-07,ACTUAL,,,,2022-10-12,2022-11-07,ACTUAL,2020-08-27,ACTUAL,2020-08-27,2022-10,2022-10-31,2021-09-02,ACTUAL,2021-09-02,2021-04-08,ACTUAL,2021-04-08,,INTERVENTIONAL,COMET-ICE,All participants who were randomly assigned to study intervention in the study ( irrespective of whether they have been dosed),VIR-7831 for the Early Treatment of COVID-19 in Outpatients,"A Phase II/III Randomized, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Monoclonal Antibody VIR-7831 for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Non-hospitalized Patients",COMPLETED,,PHASE2/PHASE3,1057.0,ACTUAL,"Vir Biotechnology, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,INDUSTRY,,,,,,,2021,1.0
NCT01996605,,2013-11-21,2023-08-07,,2023-08-31,2013-11-21,2013-11-27,ESTIMATED,2023-08-31,2023-09-14,ACTUAL,,,,2023-08-31,2023-09-14,ACTUAL,2014-01-02,,2014-01-02,2022-11,2022-11-30,2022-10-10,ACTUAL,2022-10-10,2022-10-10,ACTUAL,2022-10-10,,INTERVENTIONAL,,,Efficacy of Spinal Oxytocin in Healthy Volunteers,Efficacy of Intrathecal Oxytocin in Human Volunteers,TERMINATED,,PHASE2,20.0,ACTUAL,Wake Forest University Health Sciences,The study was powered for a sample size of 40 and was terminated early with a sample size of 20 due to slow recruitment and cessation of financial support.,3.0,,"Cessation of funding period prior to completion, due to slow recruitment during the pandemic",f,,,,t,t,f,,,,,,,,,,,2024-10-15 18:21:29.411215,2024-10-15 18:21:29.411215,OTHER,,,,,,,2022,0.0
NCT02722369,,2016-03-08,,,2021-03-16,2016-03-23,2016-03-30,ESTIMATED,,,,,,,2021-03-16,2021-03-18,ACTUAL,2017-03-14,ACTUAL,2017-03-14,2021-03,2021-03-31,2021-03-12,ACTUAL,2021-03-12,2021-03-12,ACTUAL,2021-03-12,,INTERVENTIONAL,,,STUDY 15 - Comparing Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC),"A Phase II, Multicentre, Randomised Trial Comparing Combination Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)",TERMINATED,,PHASE2,72.0,ACTUAL,"University College, London",,2.0,,"Low recruitment, lack of efficacy and increased adverse events in investigational arm.",f,,,,t,f,f,,,,,,,,,YES,"On receipt of a request the recipient will consider the proposal, ensure relevant Chief Investigator/Trial Management Group are consulted and, if necessary, Trial Steering Committee and/or Cancer Trials Centre (CTC) Senior Management Group. Any shared data will be in an anonymised format",2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,OTHER,,,,,,,2021,0.0
NCT04872608,,2021-04-29,,,2023-04-26,2021-04-30,2021-05-04,ACTUAL,,,,,,,2023-04-26,2023-04-28,ACTUAL,2021-09-09,ACTUAL,2021-09-09,2023-04,2023-04-30,2023-04-25,ACTUAL,2023-04-25,2023-04-25,ACTUAL,2023-04-25,,INTERVENTIONAL,,,"A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer","ctDNA-guided Adaptive Therapy Escalation in ER+ MBC: A Phase 1b Study With Letrozole, Palbociclib and Onapristone ER",WITHDRAWN,,PHASE1,0.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,The sponsor closed the study due to discontinuing their onapristone program,,,,,,t,f,,,f,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-16 16:32:11.32067,2024-10-16 16:32:11.32067,OTHER,,,,,,,2023,0.0
NCT02798523,,2016-06-10,2023-04-18,,2023-05-25,2016-06-10,2016-06-14,ESTIMATED,2023-05-25,2023-06-22,ACTUAL,,,,2023-05-25,2023-06-22,ACTUAL,2017-01-24,ACTUAL,2017-01-24,2022-11-14,2022-11-14,2022-11-14,ACTUAL,2022-11-14,2022-05-31,ACTUAL,2022-05-31,,INTERVENTIONAL,,,Genomic Responses of Human Immune and Non-Immune Cells to Glucocorticoids,Genomic Response of Human Immune and Non-Immune Cells to Glucocorticoids,COMPLETED,,PHASE1,33.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,NIH,,,,,,,2022,1.0
NCT04253223,,2020-01-28,,,2021-06-09,2020-01-31,2020-02-05,ACTUAL,,,,,,,2021-06-09,2021-06-11,ACTUAL,2020-04-07,ACTUAL,2020-04-07,2021-06,2021-06-30,2021-05-05,ACTUAL,2021-05-05,2021-05-05,ACTUAL,2021-05-05,,INTERVENTIONAL,,,A Study to Determine Safety and Efficacy of (REMD-477) in Controlling Hyperglycemia Due to Copanlisib,A Phase I/Ib Pilot Study to Determine the Safety and Efficacy of a Human Anti-glucagon Receptor Antibody (REMD-477) in Controlling Severe Hyperglycemia Due to Copanlisib in Patients With Relapsed or Refractory Lymphoma,TERMINATED,,PHASE1,1.0,ACTUAL,Duke University,,1.0,,poor accrual,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,OTHER,,,,,,,2021,0.0
NCT03896581,,2019-03-21,2024-09-19,2022-12-07,2024-09-19,2019-03-27,2019-04-01,ACTUAL,2024-09-19,2024-10-16,ESTIMATED,2022-12-07,2022-12-12,ACTUAL,2024-09-19,2024-10-16,ESTIMATED,2019-03-28,ACTUAL,2019-03-28,2024-09,2024-09-30,2022-02-14,ACTUAL,2022-02-14,2021-12-08,ACTUAL,2021-12-08,,INTERVENTIONAL,BE COMPLETE,Baseline Characteristics refer to Randomized Set which consisted of all enrolled participants who had been randomized.,A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis,"A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis",COMPLETED,,PHASE3,400.0,ACTUAL,UCB Pharma,,2.0,,,f,,,,t,t,f,,,f,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",http://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-17 04:21:56.486553,2024-10-17 04:21:56.486553,INDUSTRY,,,,,,,2022,1.0
NCT01847274,,2013-04-11,2018-10-18,,2023-05-31,2013-05-03,2013-05-06,ESTIMATED,2019-04-10,2019-05-01,ACTUAL,,,,2023-05-31,2023-06-02,ACTUAL,2013-06-21,ACTUAL,2013-06-21,2023-05,2023-05-31,2021-12-26,ACTUAL,2021-12-26,2016-04-22,ACTUAL,2016-04-22,,INTERVENTIONAL,,"The baseline analysis population was the intent-to-treat population, defined as all randomized participants with participants analyzed according to the study drug assigned via randomization",A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer,A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.,COMPLETED,,PHASE3,596.0,ACTUAL,"Tesaro, Inc.",,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,INDUSTRY,,,,,,,2021,1.0
NCT02393183,,2015-03-07,,,2023-09-26,2015-03-14,2015-03-19,ESTIMATED,,,,,,,2023-09-26,2023-09-28,ACTUAL,2019-07-15,ACTUAL,2019-07-15,2023-09,2023-09-30,2022-12-15,ESTIMATED,2022-12-15,2022-06-15,ESTIMATED,2022-06-15,,INTERVENTIONAL,,,The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease (TED),"The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease, a Placebo Controlled Randomized Clinical Trial",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Iran University of Medical Sciences,,3.0,,Do not access to the drug,f,,,,f,f,f,,,,,,,,,,,2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,OTHER,,,,,,,2022,0.0
NCT00001880,,2006-07-03,2021-09-13,,2021-11-08,1999-11-03,1999-11-04,ESTIMATED,2021-11-08,2021-11-10,ACTUAL,,,,2021-11-08,2021-11-10,ACTUAL,1999-03-12,ACTUAL,1999-03-12,2020-08,2020-08-31,2020-08-13,ACTUAL,2020-08-13,2008-08-14,ACTUAL,2008-08-14,,INTERVENTIONAL,,,Stem Cell Transplantation for Metastatic Solid Tumors,Exploratory Study of Non-Myeloablative Allogeneic Stem Cell Transplantation and Donor Lymphocyte Infusions for Metastatic Neoplasms Refractory to Standard Therapy,TERMINATED,,PHASE2,42.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,Study was closed early due to lack of accrual,f,,,,,t,f,,,,,,,,,,,2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,NIH,,,,,,,2020,0.0
NCT03035812,,2017-01-26,,,2020-07-13,2017-01-26,2017-01-30,ESTIMATED,,,,,,,2020-07-13,2020-07-14,ACTUAL,2017-02-01,ACTUAL,2017-02-01,2020-07,2020-07-31,2020-02-21,ACTUAL,2020-02-21,2020-02-21,ACTUAL,2020-02-21,,INTERVENTIONAL,AlcalUN,,Alkalinization by Urologists & Nephrologists,Prospective Evaluation of Oral Alkalinization by Urologists and Nephrologists: Evolution of the Extracellular Compartment,COMPLETED,,PHASE4,156.0,ACTUAL,Club des Jeunes Néphrologues,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,OTHER,,,,,,,2020,0.0
NCT04242329,,2020-01-23,,,2024-01-25,2020-01-23,2020-01-27,ACTUAL,,,,,,,2024-01-25,2024-01-26,ACTUAL,2021-03-11,ACTUAL,2021-03-11,2024-01,2024-01-31,2023-09-13,ACTUAL,2023-09-13,2023-09-03,ACTUAL,2023-09-03,,INTERVENTIONAL,SUMMIST,,Surgery of Melanoma Metastases After Systemic Therapy,Surgery of Melanoma Metastases After Systemic Therapy - the SUMMIST Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,Vastra Gotaland Region,,2.0,,"Not possible to recruit patients during COVID, and not possible to start enrolling after the pandemic.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,OTHER_GOV,,,,,,,2023,0.0
NCT04489628,,2020-07-24,,,2022-02-04,2020-07-24,2020-07-28,ACTUAL,,,,,,,2022-02-04,2022-02-07,ACTUAL,2020-08-01,ACTUAL,2020-08-01,2022-02,2022-02-28,2021-06-01,ACTUAL,2021-06-01,2021-06-01,ACTUAL,2021-06-01,,INTERVENTIONAL,,,Tele-health Enabled Clinical Trial for COVID-19,Tele-health Enabled Clinical Trial for COVID-19: Vitamin D as an Immunomodulator to Prevent Complications and Reduce Resource Utilization in Outpatients,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University Hospitals Cleveland Medical Center,,2.0,,Unable to overcome hurdles to study recruitment,f,,,,,t,t,,,,,,,,,NO,,2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,OTHER,,,,,,,2021,0.0
NCT04302896,,2020-03-06,,,2022-03-02,2020-03-06,2020-03-10,ACTUAL,,,,,,,2022-03-02,2022-03-03,ACTUAL,2020-08-31,ACTUAL,2020-08-31,2022-03,2022-03-31,2021-09-30,ACTUAL,2021-09-30,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,APTAMER,,Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs,"APT-POCT-01: An Open Label, Pharmacokinetic Study of Plasma/Urine/Salivary Drug Concentrations Over Fourteen Days Following Drug Intake Cessation, In HIV-Uninfected Healthy Volunteers Dosing to Steady-state to Further Development of Point of Care Diagnostic Testing",COMPLETED,,EARLY_PHASE1,30.0,ACTUAL,University of Pittsburgh,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,OTHER,,,,,,,2021,1.0
NCT03949530,,2019-05-06,,,2020-07-31,2019-05-13,2019-05-14,ACTUAL,,,,,,,2020-07-31,2020-08-04,ACTUAL,2019-04-16,ACTUAL,2019-04-16,2020-07,2020-07-31,2020-03-29,ACTUAL,2020-03-29,2020-03-29,ACTUAL,2020-03-29,,INTERVENTIONAL,,,A Study of Safety & Blood Levels of IDL-2965 in Healthy Subjects and Patients With a Special Type of Pulmonary Fibrosis,"IDL-2965 - A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis (IPF)",TERMINATED,,PHASE1,6.0,ACTUAL,"Indalo Therapeutics, Inc.",,2.0,,Due to development challenges associated with the SARS-CoV-2 pandemic and emerging nonclinical data,f,,,,f,f,f,,,f,,,,,,,,2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,INDUSTRY,,,,,,,2020,0.0
NCT04446000,,2020-06-22,,,2023-11-28,2020-06-22,2020-06-24,ACTUAL,,,,,,,2023-11-28,2023-11-29,ACTUAL,2020-09-23,ACTUAL,2020-09-23,2023-11,2023-11-30,2023-03-28,ACTUAL,2023-03-28,2023-03-28,ACTUAL,2023-03-28,,INTERVENTIONAL,,,"Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects","A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects",TERMINATED,,PHASE1,52.0,ACTUAL,CSL Behring,,11.0,,Lack of clinical viability,f,,,,f,f,f,,,,,,IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.,Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.~An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.~The requesting party must execute an appropriate data sharing agreement before IPD will be made available.,,YES,"CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.~Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.~If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.",2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,INDUSTRY,,,,,,,2023,0.0
NCT03192215,,2017-06-16,,,2023-06-06,2017-06-16,2017-06-20,ACTUAL,,,,,,,2023-06-06,2023-06-07,ACTUAL,2018-01-19,ACTUAL,2018-01-19,2023-06,2023-06-30,2023-04-17,ACTUAL,2023-04-17,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,ARCADIA,,AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke,AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke,TERMINATED,,PHASE3,1015.0,ACTUAL,Columbia University,,2.0,,The DSMB halted the trial prematurely due to futility without any safety concerns.,f,,,,t,t,f,,,f,,,As per NIH/NINDS requirements.,All items required by NIH/NINDS will be publicly shared.,,YES,"To share individual participant data (IPD) of baseline characteristics, follow up, outcomes, etc. based on NIH/NINDS requirements.",2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,OTHER,,,,,,,2023,0.0
NCT04956575,,2021-06-30,2023-09-25,,2023-10-25,2021-06-30,2021-07-09,ACTUAL,2023-10-25,2023-10-27,ACTUAL,,,,2023-10-25,2023-10-27,ACTUAL,2021-07-06,ACTUAL,2021-07-06,2023-10,2023-10-31,2022-09-27,ACTUAL,2022-09-27,2022-09-27,ACTUAL,2022-09-27,,INTERVENTIONAL,,Safety Set: All randomly assigned participants who received the investigational product.,A Study of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults,"A Phase 1/2, Randomized, Stratified, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults 18 Years and Older",COMPLETED,,PHASE1/PHASE2,885.0,ACTUAL,"ModernaTX, Inc.",,12.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,,,,,,2022,1.0
NCT04115293,,2019-10-02,2022-12-19,,2024-10-01,2019-10-02,2019-10-04,ACTUAL,2022-12-19,2023-01-17,ACTUAL,,,,2024-10-01,2024-10-15,ACTUAL,2019-09-17,ACTUAL,2019-09-17,2024-09,2024-09-30,2021-12-30,ACTUAL,2021-12-30,2021-12-30,ACTUAL,2021-12-30,,INTERVENTIONAL,RAISE,The modified Intention-to-Treat (mITT) population included all randomized participants who received at least 1 dose of study drug and had at least 1 post-dosing MG-ADL score.,"Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis","A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis",COMPLETED,,PHASE3,174.0,ACTUAL,UCB Pharma,,2.0,,,f,,,,,t,f,,,,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",http://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed;in this case and to protect participants, individual patient-level data would not be made available.",2024-10-17 04:21:56.486553,2024-10-17 04:21:56.486553,INDUSTRY,,,,,,,2021,1.0
NCT03408483,,2017-12-19,2020-05-21,,2021-05-24,2018-01-22,2018-01-24,ACTUAL,2020-08-18,2020-09-04,ACTUAL,,,,2021-05-24,2021-06-09,ACTUAL,2018-04-01,ACTUAL,2018-04-01,2021-05,2021-05-31,2020-08-22,ACTUAL,2020-08-22,2019-05-10,ACTUAL,2019-05-10,,INTERVENTIONAL,,Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the Quadratus Lumborum Block group for missing data due to early discharge.,Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty,Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty,COMPLETED,,PHASE2/PHASE3,80.0,ACTUAL,University of Alabama at Birmingham,,2.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,OTHER,,,,,,,2020,1.0
NCT03379051,,2017-12-14,,,2022-08-19,2017-12-14,2017-12-20,ACTUAL,,,,,,,2022-08-19,2022-08-22,ACTUAL,2018-03-27,ACTUAL,2018-03-27,2022-08,2022-08-31,2022-06-16,ACTUAL,2022-06-16,2022-05-26,ACTUAL,2022-05-26,,INTERVENTIONAL,,,Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL,Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL,TERMINATED,,PHASE1/PHASE2,78.0,ACTUAL,"TG Therapeutics, Inc.",,2.0,,Strategic/Business Decision,f,,,,f,t,f,,,,,,,,,,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,,,,,,2022,0.0
NCT03066115,,2017-02-22,,,2019-01-08,2017-02-23,2017-02-28,ACTUAL,,,,,,,2019-01-08,2019-01-10,ACTUAL,2020-12-01,ESTIMATED,2020-12-01,2019-01,2019-01-31,2021-12-01,ESTIMATED,2021-12-01,2021-12-01,ESTIMATED,2021-12-01,,INTERVENTIONAL,,,"Impact of NOS, COX, and ROS Inhibition on Cerebral Blood Flow Regulation","Contributions of Nitric Oxide Synthase, Cyclooxygenase, and Reactive Oxygen Species to Regional Cerebrovascular Control During Hypoxia and Hypercapnia",WITHDRAWN,,PHASE1,0.0,ACTUAL,"University of Wisconsin, Madison",,2.0,,"This study was never funded, never fully IRB approved, and thus never enrolled anyone.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,OTHER,,,,,,,2021,0.0
NCT05584137,,2022-10-14,,,2024-10-08,2022-10-14,2022-10-18,ACTUAL,,,,,,,2024-10-08,2024-10-15,ACTUAL,2023-06-15,ACTUAL,2023-06-15,2024-10,2024-10-31,2023-12-31,ACTUAL,2023-12-31,2023-12-31,ACTUAL,2023-12-31,,INTERVENTIONAL,,,"Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients with MCRC","A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) in Combination with Serplulimab in Patients with MCRC That Have Received 3 Prior Lines of Therapy",TERMINATED,,PHASE2,2.0,ACTUAL,Shanghai Henlius Biotech,,5.0,,"Due to poor clinical trial accrual, the study was terminated.",f,,,,t,f,f,,,f,,,,,,NO,,2024-10-17 04:21:56.486553,2024-10-17 04:21:56.486553,INDUSTRY,,,,,,,2023,0.0
NCT02122172,,2014-04-22,,,2024-05-28,2014-04-23,2014-04-24,ESTIMATED,,,,,,,2024-05-28,2024-05-29,ACTUAL,2017-09-13,ACTUAL,2017-09-13,2024-05,2024-05-31,2024-04-04,ACTUAL,2024-04-04,2024-04-04,ACTUAL,2024-04-04,,INTERVENTIONAL,,,Afatinib in Advanced Refractory Urothelial Cancer,Afatinib Dimaleate in Treating Patients With Advanced Refractory Urothelial Cancer,TERMINATED,,PHASE2,95.0,ACTUAL,University of Chicago,,1.0,,Unable to meet accrual goal after several years,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,OTHER,,,,,,,2024,0.0
NCT04616586,,2020-10-10,,,2021-04-15,2020-10-29,2020-11-05,ACTUAL,,,,,,,2021-04-15,2021-04-19,ACTUAL,2020-11-13,ACTUAL,2020-11-13,2021-01,2021-01-31,2021-04-01,ACTUAL,2021-04-01,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,SILVAR,,SILtuximab in Viral ARds (SILVAR) Study,A Study Comparing the Efficacy and Safety of Standard of Care With or Without Siltuximab in Selected Hospitalized Patients With Viral Acute Respiratory Distress Syndrome (SILVAR),TERMINATED,,PHASE3,555.0,ACTUAL,EusaPharma (UK) Limited,,2.0,,The REMAP-CAP and RECOVERY substudy results appear to support the survival benefit of tocilizumab in corticosteroid-treated or untreated patients with critically ill COVID-19-associated ARDS.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,INDUSTRY,,,,,,,2021,0.0
NCT03128411,,2017-03-28,2020-03-12,,2022-04-26,2017-04-20,2017-04-25,ACTUAL,2020-11-02,2020-11-24,ACTUAL,,,,2022-04-26,2022-05-19,ACTUAL,2017-05-15,ACTUAL,2017-05-15,2022-04,2022-04-30,2021-03-04,ACTUAL,2021-03-04,2019-03-12,ACTUAL,2019-03-12,,INTERVENTIONAL,,As-treated population included all enrolled participants who received at least 1 dose of study treatment.,Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia,"A PHASE 2, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE EFFICACY AND SAFETY OF BOSUTINIB MONOTHERAPY IN JAPANESE ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA",COMPLETED,,PHASE2,64.0,ACTUAL,Pfizer,,1.0,,,f,,,,f,f,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,INDUSTRY,,,,,,,2021,1.0
NCT04092582,,2019-09-13,2023-05-11,,2023-08-11,2019-09-13,2019-09-17,ACTUAL,2023-08-11,2023-08-14,ACTUAL,,,,2023-08-11,2023-08-14,ACTUAL,2019-10-31,ACTUAL,2019-10-31,2023-08,2023-08-31,2022-05-19,ACTUAL,2022-05-19,2022-05-19,ACTUAL,2022-05-19,,INTERVENTIONAL,,Modified Intent-to-Treat population (mITT) population included all randomized participants who received at least one dose of study treatment.,"A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller","A Phase IIa, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller",COMPLETED,,PHASE2,135.0,ACTUAL,"Genentech, Inc.","Enrollment was halted on 08 April 2020 in response to the emerging pandemic and concerns regarding data integrity (e.g., missed study doses and visits). The trial was restarted on 22 June 2020.",2.0,,,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)",2024-10-15 08:53:39.397995,2024-10-15 08:53:39.397995,INDUSTRY,,,,,,,2022,1.0
NCT03153111,,2017-03-30,2022-03-09,,2023-04-28,2017-05-12,2017-05-15,ACTUAL,2022-03-09,2022-04-04,ACTUAL,,,,2023-04-28,2023-05-03,ACTUAL,2017-07-11,ACTUAL,2017-07-11,2023-04,2023-04-30,2021-03-12,ACTUAL,2021-03-12,2021-03-12,ACTUAL,2021-03-12,,INTERVENTIONAL,SERENADE,Baseline analysis population includes full analysis set (FAS) which included participants randomized to double-blind study treatment.,A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease,"A Multi-center, Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease",COMPLETED,,PHASE2,143.0,ACTUAL,Actelion,Recruitment was stopped prematurely in December 2019 due to slow enrollment which resulted in an underpowered study and impacted the meaningful interpretation of the results.,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 07:11:01.772078,2024-10-16 07:11:01.772078,INDUSTRY,,,,,,,2021,1.0
NCT02332577,,2015-01-05,,,2023-05-05,2015-01-05,2015-01-07,ESTIMATED,,,,,,,2023-05-05,2023-05-08,ACTUAL,2015-04-30,ACTUAL,2015-04-30,2023-05,2023-05-31,2023-02-20,ACTUAL,2023-02-20,2023-02-20,ACTUAL,2023-02-20,,INTERVENTIONAL,,,Study to Compare the Efficacy of Pristinamycin (Pyostacine ®) Versus Amoxicillin in the Treatment of Acute Community Acquired Pneumonia,"A Multi-centre, Non-inferiority, Randomized, Double-blind, Phase IV Study Comparing Pristinamycin (2g x 2 Per Day for 2 Days Then 1g x 3 Per Day for 5 to 7 Days) to Amoxicillin (1g x 3 Per Day) for 7 to 9 Days in Adults With Acute Community Acquired Pneumonia With a PORT Score of II or III",TERMINATED,,PHASE4,161.0,ACTUAL,Sanofi,,2.0,,The sponsor stopped the study due to low recruitment with no safety concerns,f,,,,t,,,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,,,,,,2023,0.0
NCT04207710,,2019-12-19,2023-06-16,,2024-03-01,2019-12-19,2019-12-23,ACTUAL,2024-03-01,2024-03-04,ACTUAL,,,,2024-03-01,2024-03-04,ACTUAL,2021-01-26,ACTUAL,2021-01-26,2024-03,2024-03-31,2022-02-25,ACTUAL,2022-02-25,2022-02-25,ACTUAL,2022-02-25,,INTERVENTIONAL,,,Safety of Gebauer's Pain Ease and Gebauer's Ethyl Chloride,Study to Determine the Safety of Gebauer's Ethyl Chloride and Gebauer's Pain Ease Sprays When Used Following ChloraPrep for Invasive Procedures,COMPLETED,,PHASE4,72.0,ACTUAL,Henry Ford Health System,,4.0,,,f,,,,,t,f,,,t,,,,,,NO,,2024-10-16 06:32:44.547183,2024-10-16 06:32:44.547183,OTHER,,,,,,,2022,1.0
NCT04456608,,2020-06-29,,,2023-12-08,2020-06-29,2020-07-02,ACTUAL,,,,,,,2023-12-08,2023-12-15,ACTUAL,2016-08-01,ACTUAL,2016-08-01,2023-12,2023-12-31,2023-07-31,ACTUAL,2023-07-31,2023-07-31,ACTUAL,2023-07-31,,INTERVENTIONAL,,,Genetic and Dietary Predictors of Anti-platelet Response,"Program on Genetic and Dietary Predictors of Drug Response in Rural and AI/AN Populations, Project-3, SA-3, Anti-platelet Response",TERMINATED,,PHASE4,126.0,ACTUAL,University of Washington,,1.0,,"Funding ended before the study could be completed,",f,,,,f,t,f,,,t,,,,,,,,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,OTHER,,,,,,,2023,0.0
NCT03085394,,2017-03-19,,,2023-04-14,2017-03-20,2017-03-21,ACTUAL,,,,,,,2023-04-14,2023-04-19,ACTUAL,2017-09-01,ACTUAL,2017-09-01,2023-04,2023-04-30,2022-11-21,ACTUAL,2022-11-21,2022-11-21,ACTUAL,2022-11-21,,INTERVENTIONAL,PHORBBS,,Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery,Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery,TERMINATED,,PHASE3,152.0,ACTUAL,Sheba Medical Center,,2.0,,"Enrollment stopped, patients refuse to participate.",f,,,,f,f,f,,,f,,,,,,,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,OTHER_GOV,,,,,,,2022,0.0
NCT03950674,,2019-05-13,2020-05-07,,2024-05-13,2019-05-13,2019-05-15,ACTUAL,2020-06-09,2020-06-11,ACTUAL,,,,2024-05-13,2024-06-10,ACTUAL,2016-02-22,ACTUAL,2016-02-22,2024-05,2024-05-31,2023-06-22,ACTUAL,2023-06-22,2019-05-20,ACTUAL,2019-05-20,,INTERVENTIONAL,,The Baseline Analysis Population consisted of all randomized participants.,Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)-Japan Extension Study,"A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189)",COMPLETED,,PHASE3,40.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,,,,,,2023,1.0
NCT03797443,,2018-12-05,,,2019-05-30,2019-01-07,2019-01-09,ACTUAL,,,,,,,2019-05-30,2019-05-31,ACTUAL,2019-01-01,ACTUAL,2019-01-01,2019-05,2019-05-31,2022-12,ESTIMATED,2022-12-31,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,,,High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer,Phase IB/II Trial of High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Had No Prior Therapy for Their Metastatic Pancreatic Cancer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Piedmont Cancer Institute,,1.0,,Regulatory Review needed,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,OTHER,,,,,,,2022,0.0
NCT04800822,,2021-03-09,,,2024-10-14,2021-03-13,2021-03-16,ACTUAL,,,,,,,2024-10-14,2024-10-16,ESTIMATED,2021-03-17,ACTUAL,2021-03-17,2024-10,2024-10-31,2024-06-19,ACTUAL,2024-06-19,2024-06-19,ACTUAL,2024-06-19,,INTERVENTIONAL,,,PF-07284892 in Participants With Advanced Solid Tumors,"A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY EVIDENCE OF ANTI-TUMOR ACTIVITY OF PF-07284892 (ARRY-558) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS",TERMINATED,,PHASE1,53.0,ACTUAL,Pfizer,,9.0,,"The study was prematurely discontinued due to strategic reasons, not major safety concerns, futility, or requests from any regulatory authorities",f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 04:21:56.486553,2024-10-17 04:21:56.486553,INDUSTRY,,,,,,,2024,0.0
NCT02564796,,2015-09-29,2021-11-03,,2021-11-03,2015-09-30,2015-10-01,ESTIMATED,2021-11-03,2021-12-02,ACTUAL,,,,2021-11-03,2021-12-02,ACTUAL,2016-11,ACTUAL,2016-11-30,2021-11,2021-11-30,2020-06,ACTUAL,2020-06-30,2020-06,ACTUAL,2020-06-30,,INTERVENTIONAL,,,Erythropoietin to Prevent Unnecessary Transfusions In Patients With Cyanotic CHD - A Prospective Control Trial,Erythropoietin to Prevent Unnecessary Transfusions In Patients With Cyanotic Congenital Heart Disease - A Prospective Randomized Control Trial,TERMINATED,,PHASE2,4.0,ACTUAL,"University of California, San Diego",The principal investigator discussed the study's future with the sub-investigators on the study and came to the conclusion to terminate the study early due to low enrollment while also considering the financial costs to continue to run the study. It would be highly improbable to be able to enroll 54 more patients with the amount of funding left in the grant. No subjects were analyzed.,2.0,,COVID,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,OTHER,,,,,,,2020,0.0
NCT04330625,,2020-03-31,,,2022-11-04,2020-03-31,2020-04-01,ACTUAL,,,,,,,2022-11-04,2022-11-08,ACTUAL,2020-11-13,ACTUAL,2020-11-13,2022-11,2022-11-30,2021-05-05,ACTUAL,2021-05-05,2021-05-05,ACTUAL,2021-05-05,,INTERVENTIONAL,,,Glucagon Receptor Inhibition to Enable Breast Cancer Patients to Benefit From PI3K Inhibitor Therapy (REMD-477),A Pilot Study of Glucagon Receptor Inhibition to Enable Breast Cancer Patients to Benefit From PI3K Inhibitor Therapy (GRIP-IT PILOT),TERMINATED,,PHASE1,1.0,ACTUAL,Duke University,,1.0,,Lack of enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,OTHER,,,,,,,2021,0.0
NCT01784159,,2013-02-01,,,2023-07-12,2013-02-04,2013-02-05,ESTIMATED,,,,,,,2023-07-12,2023-07-13,ACTUAL,2019-03-27,ACTUAL,2019-03-27,2023-07,2023-07-31,2023-01-05,ACTUAL,2023-01-05,2022-12-15,ACTUAL,2022-12-15,,INTERVENTIONAL,ASP-SEPSIS,,ASpirin for Patients With SEPsis and SeptIc Shock,"Impact of Aspirin Use on the Severity of Organ Dysfunctions in Patients With Sepsis and Septic Shock: a Randomized, Double-blind, Placebo-controlled Trial - ASP-SEPSIS.",TERMINATED,,PHASE2,167.0,ACTUAL,Federal University of São Paulo,,2.0,,"Terminated: The study was stopped prematurely and will not be resumed due to the higher number of bleeding cases in the intervention group, as recomended by the Data Safety Monitoring Board on February 7, 2023.",f,,,,f,f,f,,,,,,,,,UNDECIDED,undecided,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,OTHER,,,,,,,2023,0.0
NCT03725852,,2018-06-08,2021-07-14,,2021-08-18,2018-10-29,2018-10-31,ACTUAL,2021-08-18,2021-09-14,ACTUAL,,,,2021-08-18,2021-09-14,ACTUAL,2018-09-27,ACTUAL,2018-09-27,2021-08,2021-08-31,2020-08-14,ACTUAL,2020-08-14,2020-07-21,ACTUAL,2020-07-21,,INTERVENTIONAL,PINTA,Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.,A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF),"A Phase II Randomized, Double-blind, Placebo-controlled, 26-week Study to Evaluate the Efficacy, Safety and Tolerability of GLPG1205 in Subjects With Idiopathic Pulmonary Fibrosis",COMPLETED,,PHASE2,68.0,ACTUAL,Galapagos NV,"The study was not powered to detect statistical significance and was limited by its small sample size, high variability of the primary endpoint (FVC), and a high rate of early treatment discontinuations.",2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,INDUSTRY,,,,,,,2020,1.0
NCT01667744,,2012-08-12,,,2022-12-07,2012-08-14,2012-08-17,ESTIMATED,,,,,,,2022-12-07,2022-12-09,ACTUAL,2016-01-01,ESTIMATED,2016-01-01,2022-12,2022-12-31,2021-02-16,ACTUAL,2021-02-16,2016-02-01,ESTIMATED,2016-02-01,,INTERVENTIONAL,,,Citalopram for Sx/Util in Acute Coronary Syndrome Patients,Citalopram for Sx/Util in Acute Coronary Syndrome Patients,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Henry Ford Health System,,2.0,,unfunded,f,,,,t,,,,,,,,,,,UNDECIDED,Study not funded.,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,OTHER,,,,,,,2021,0.0
NCT04900766,,2021-05-20,,,2024-03-05,2021-05-20,2021-05-25,ACTUAL,,,,,,,2024-03-05,2024-03-07,ACTUAL,2021-08-11,ACTUAL,2021-08-11,2024-02,2024-02-29,2023-02-03,ACTUAL,2023-02-03,2023-02-03,ACTUAL,2023-02-03,,INTERVENTIONAL,,,A Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Bone and Soft Tissue Sarcoma,"A Multicenter, Open-label, Phase Ib Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Bone and Soft Tissue Sarcoma Who Has Failed At Least One Prior Line of Therapy",TERMINATED,,PHASE1,31.0,ACTUAL,"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.",,1.0,,The sponsor has adjusted its R\&D strategy.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,,,,,,2023,0.0
NCT04154735,,2019-03-08,,,2019-11-06,2019-11-04,2019-11-06,ACTUAL,,,,,,,2019-11-06,2019-11-08,ACTUAL,2019-11,ESTIMATED,2019-11-30,2019-01,2019-01-31,2024-03,ESTIMATED,2024-03-31,2023-03,ESTIMATED,2023-03-31,,INTERVENTIONAL,ATTAC,,Autologous Transplant Targeted Against Crohn's,Autologous Hematopoietic Stem Cell Transplant for Crohn's Disease,WITHDRAWN,,PHASE2,0.0,ACTUAL,Northwestern University,,1.0,,Discontinued by Investigator,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,OTHER,,,,,,,2024,0.0
NCT03397186,,2018-01-05,,,2019-09-06,2018-01-05,2018-01-11,ACTUAL,,,,,,,2019-09-06,2019-09-10,ACTUAL,2018-06-19,ACTUAL,2018-06-19,2019-09,2019-09-30,2021-05-01,ESTIMATED,2021-05-01,2021-01-01,ESTIMATED,2021-01-01,,INTERVENTIONAL,,,Immune Changes Following Trabectedin in Patients With Metastatic or Unresectable Sarcoma,An Analysis of the Changes in the Sarcoma Tumor Immune Microenvironment Following Trabectedin,WITHDRAWN,,PHASE2,0.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,Administrative,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,OTHER,,,,,,,2021,0.0
NCT04002622,,2019-06-27,,,2021-01-21,2019-06-27,2019-06-28,ACTUAL,,,,,,,2021-01-21,2021-01-25,ACTUAL,2019-08-06,ACTUAL,2019-08-06,2021-01,2021-01-31,2021-01-21,ACTUAL,2021-01-21,2021-01-21,ACTUAL,2021-01-21,,INTERVENTIONAL,,,Study of TQB2450 Injection in Subjects With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma,"A Phase II, Multicenter, Open, Single-arm Study of TQB2450 Injection (PD-L1 Antibody) in Subjects With Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL)",TERMINATED,,PHASE2,1.0,ACTUAL,"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",,1.0,,The population of target indication is small and screening is difficult.,f,,,,,f,f,,,,,,,,,,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,,,,,,2021,0.0
NCT04512079,,2020-08-11,,,2023-03-15,2020-08-11,2020-08-13,ACTUAL,,,,,,,2023-03-15,2023-03-16,ACTUAL,2020-09-08,ACTUAL,2020-09-08,2023-03,2023-03-31,2022-12-30,ACTUAL,2022-12-30,2022-12-30,ACTUAL,2022-12-30,,INTERVENTIONAL,FREEDOM COVID,,FREEDOM COVID-19 Anticoagulation Strategy,FREEDOM COVID Anticoagulation Strategy Randomized Trial,COMPLETED,,PHASE4,3460.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,3.0,,,,,,,t,t,f,,,,,,Beginning 9 months and ending 36 months following article publication.,Investigators whose proposed use of the data has been approved by an independent review committee (learned intermediary) identified for this purpose. The type of analysis that will be conducted is for individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.,,YES,"Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).",2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,OTHER,,,,,,,2022,0.0
NCT05222269,,2022-01-05,,,2023-05-08,2022-02-02,2022-02-03,ACTUAL,,,,,,,2023-05-08,2023-05-10,ACTUAL,2022-10-05,ACTUAL,2022-10-05,2023-05,2023-05-31,2023-01-25,ACTUAL,2023-01-25,2023-01-25,ACTUAL,2023-01-25,,INTERVENTIONAL,,,[68Ga]Ga-PentixaFor PET Imaging in CNS Lymphoma Patients,"A Prospective, International, Multi-centre, Open-label, Single-arm Phase II Study Investigating the Predictive Value of [68Ga]Ga PentixaFor PET Imaging in Primary and Isolated Secondary CNS Lymphoma Patients",TERMINATED,,PHASE2,1.0,ACTUAL,Pentixapharm AG,,1.0,,"The study was early terminated due to low patient recruitment in already activated sites and difficult approval process in some of the anticipated countries. Thus, recruitment of the planned patient numbers in a reasonable time cannot be expected.",f,,,,f,f,f,,,,,,,,,,,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,INDUSTRY,,,,,,,2023,0.0
NCT03697239,,2018-09-21,,,2019-06-06,2018-10-03,2018-10-05,ACTUAL,,,,,,,2019-06-06,2019-06-11,ACTUAL,2019-06,ESTIMATED,2019-06-30,2019-06,2019-06-30,2022-12,ESTIMATED,2022-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer,Phase IB/II Trial of High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have No Prior Therapy for Their Metastatic Pancreatic Cancer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"University of California, San Diego",,1.0,,FDA indicated the same study could not be conducted under multiple INDs,,,,,,t,f,,,,,,,,,,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,OTHER,,,,,,,2022,0.0
NCT02785120,,2016-05-05,,,2024-01-04,2016-05-24,2016-05-27,ESTIMATED,,,,,,,2024-01-04,2024-01-05,ACTUAL,2017-03-01,ACTUAL,2017-03-01,2024-01,2024-01-31,2024-12,ESTIMATED,2024-12-31,2024-10,ESTIMATED,2024-10-31,,INTERVENTIONAL,TF0023,,A Study to Evaluate the Efficacy and Safety of TF0023 Spray on Subjects With Ischemic Strokes,"A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Study to Evaluate the Efficacy and Safety of TF0023 Spray Versus Placebo in Functional Improvement of Patients With Ischemic Strokes",SUSPENDED,,PHASE2,225.0,ESTIMATED,Techfields Inc,,3.0,,Suspended due to enrollment challenges and business operations.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,INDUSTRY,,,,,,,2024,0.0
NCT02515669,,2015-07-29,2019-02-07,,2020-10-13,2015-08-03,2015-08-05,ESTIMATED,2019-04-17,2019-05-08,ACTUAL,,,,2020-10-13,2020-11-04,ACTUAL,2015-12-02,ACTUAL,2015-12-02,2020-10,2020-10-31,2020-04-15,ACTUAL,2020-04-15,2018-02-08,ACTUAL,2018-02-08,,INTERVENTIONAL,,"Doses tested in this study were based upon achieving and maintaining moderate (\> 50% suppression), high (\> 85%), and near complete (\> 95%) suppression of serum free myostatin levels for Panels 1, 2, and 3 and Expansion Panel, respectively. Panel 3 was expanded after at least 2 weeks of dosing had been complete by at least 6 participants.","Study of an Investigational Drug, RO7239361 (BMS-986089), in Ambulatory Boys With DMD","A Multi-Site, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7239361 (BMS-986089) in Ambulatory Boys With Duchenne Muscular Dystrophy",TERMINATED,,PHASE1/PHASE2,43.0,ACTUAL,Hoffmann-La Roche,,2.0,,A pre-planned futility analysis indicated lack of efficacy in study NCT03039686 and led to discontinuation of both ongoing studies in DMD.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,INDUSTRY,,,,,,,2020,0.0
NCT04987294,,2021-07-26,,,2023-06-21,2021-07-26,2021-08-03,ACTUAL,,,,,,,2023-06-21,2023-06-23,ACTUAL,2022-09-02,ACTUAL,2022-09-02,2023-06,2023-06-30,2022-09-02,ACTUAL,2022-09-02,2022-09-02,ACTUAL,2022-09-02,,INTERVENTIONAL,,,"Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease","A Randomized, Double-Blind, Placebo-Controlled Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects With Gout and Mild to Moderate Chronic Kidney Disease",TERMINATED,,PHASE2,19.0,ACTUAL,Allena Pharmaceuticals,,2.0,,Company Financing,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,,,,,,2022,0.0
NCT03666143,,2018-08-21,2023-12-18,,2023-12-18,2018-09-09,2018-09-11,ACTUAL,2023-12-18,2024-06-17,ACTUAL,,,,2023-12-18,2024-06-17,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2023-12,2023-12-31,2023-01-05,ACTUAL,2023-01-05,2023-01-05,ACTUAL,2023-01-05,,INTERVENTIONAL,,,A Phase 1b Study to Assess Sitravatinib in Combination With Tislelizumab in Participants With Advanced Solid Tumors,"A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors",COMPLETED,,PHASE1,216.0,ACTUAL,BeiGene,,1.0,,,f,,,,t,t,f,,,t,,,,,,YES,,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,,,,,,2023,1.0
NCT04159493,,2019-10-22,,,2021-07-19,2019-11-08,2019-11-12,ACTUAL,,,,,,,2021-07-19,2021-07-23,ACTUAL,2021-06-05,ESTIMATED,2021-06-05,2021-07,2021-07-31,2023-05-15,ESTIMATED,2023-05-15,2023-02-28,ESTIMATED,2023-02-28,,INTERVENTIONAL,DOVE,,A Randomized Controlled Phase 2 Study to Determine Lowest Efficacious Dose of Ovestin in Vulvar and Vaginal Atrophy,"A Randomized, Double-blind, Placebo-Controlled, Dose De-escalation Phase 2 Study of Various Doses of Ovestin in the Treatment of Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women",WITHDRAWN,,PHASE2,0.0,ACTUAL,Aspen Global Incorporated,,2.0,,Project terminated IND withdrawn,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,,,,,,2023,0.0
NCT02576795,,2015-10-05,,,2024-08-05,2015-10-13,2015-10-15,ESTIMATED,,,,,,,2024-08-05,2024-08-06,ACTUAL,2015-09-28,ACTUAL,2015-09-28,2024-08,2024-08-31,2024-02-14,ACTUAL,2024-02-14,2024-02-14,ACTUAL,2024-02-14,,INTERVENTIONAL,,,Gene Therapy Study in Severe Haemophilia A Patients (270-201),"A Phase 1/2, Dose-Escalation, Safety, Tolerability and Efficacy Study of Valoctocogene Roxaparvovec, an Adenovirus-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Patients With Severe Haemophilia A",COMPLETED,,PHASE1/PHASE2,15.0,ACTUAL,BioMarin Pharmaceutical,,1.0,,,f,,,,,t,f,,,t,,,,,,,,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,INDUSTRY,,,,,,,2024,1.0
NCT04272034,,2020-02-13,,,2024-10-14,2020-02-13,2020-02-17,ACTUAL,,,,,,,2024-10-14,2024-10-16,ESTIMATED,2021-03-26,ACTUAL,2021-03-26,2024-10,2024-10-31,2024-08-16,ACTUAL,2024-08-16,2024-08-16,ACTUAL,2024-08-16,,INTERVENTIONAL,,,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors","A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Select Advanced Solid Tumors",TERMINATED,,PHASE1,105.0,ACTUAL,Incyte Corporation,,3.0,,A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.,f,,,,t,t,f,,,,,,,,,NO,Access to patient level data is not available for this study,2024-10-17 04:21:56.486553,2024-10-17 04:21:56.486553,INDUSTRY,,,,,,,2024,0.0
NCT02053246,,2014-01-24,2022-01-19,,2022-01-19,2014-01-30,2014-02-03,ESTIMATED,2022-01-19,2022-02-10,ACTUAL,,,,2022-01-19,2022-02-10,ACTUAL,2014-01,ACTUAL,2014-01-31,2022-01,2022-01-31,2021-03,ACTUAL,2021-03-31,2021-03,ACTUAL,2021-03-31,,INTERVENTIONAL,,,Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure,Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure,TERMINATED,,PHASE4,11.0,ACTUAL,University of Florida,Trial was stopped prior to completion because funding ended.,1.0,,Study funding ended before recruitment completed.,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,OTHER,,,,,,,2021,0.0
NCT03820258,,2019-01-14,2020-08-13,,2020-09-28,2019-01-25,2019-01-29,ACTUAL,2020-08-13,2020-08-31,ACTUAL,,,,2020-09-28,2020-10-23,ACTUAL,2019-01-28,ACTUAL,2019-01-28,2020-09,2020-09-30,2020-02-19,ACTUAL,2020-02-19,2019-12-04,ACTUAL,2019-12-04,,INTERVENTIONAL,,The Safety Analysis Set included participants who received at least 1 dose of study drug.,"Study to Investigate Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children With Chronic Hepatitis C Virus (HCV) Infection","A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed Dose Combination in Adolescents and Children With Chronic HCV Infection",TERMINATED,,PHASE2,21.0,ACTUAL,Gilead Sciences,,6.0,,SOF/VEL/VOX will not be evaluated in younger age groups.,f,,,,t,t,f,,,t,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy",2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,,,,,,2020,0.0
NCT03405714,,2018-01-12,2021-09-08,,2022-04-15,2018-01-12,2018-01-23,ACTUAL,2021-10-27,2021-11-26,ACTUAL,,,,2022-04-15,2022-05-11,ACTUAL,2018-06-01,ACTUAL,2018-06-01,2021-12,2021-12-31,2020-11-04,ACTUAL,2020-11-04,2020-11-04,ACTUAL,2020-11-04,,INTERVENTIONAL,,"Baseline Characteristics refer to SS-iv, which included study participants who received at least 1 dose of iv BRV.","A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy","A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month < 16 Years of Age With Epilepsy",COMPLETED,,PHASE2,50.0,ACTUAL,UCB Pharma,,1.0,,,t,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,NCT03532516,AVAILABLE,,,,2020,1.0
NCT03230097,,2017-07-24,2022-03-14,,2022-06-03,2017-07-24,2017-07-26,ACTUAL,2022-06-03,2022-06-29,ACTUAL,,,,2022-06-03,2022-06-29,ACTUAL,2017-09-29,ACTUAL,2017-09-29,2022-06,2022-06-30,2021-04-07,ACTUAL,2021-04-07,2021-03-17,ACTUAL,2021-03-17,,INTERVENTIONAL,,The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.,This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year,"A Phase II Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered BI 409306 During a 52-week Treatment Period as an Early Intervention in Patients With Attenuated Psychosis Syndrome.",TERMINATED,,PHASE2,50.0,ACTUAL,Boehringer Ingelheim,"The sponsor decided to prematurely stop enrollment. This decision was based on the unfortunate inability to meet expected enrolment goals, a situation made far worse by the impact of the COVID-19 pandemic.",2.0,,disruption due to COVID-19,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,INDUSTRY,,,,,,,2021,0.0
NCT05047523,,2021-09-09,2024-06-20,,2024-09-16,2021-09-09,2021-09-17,ACTUAL,2024-09-16,2024-10-15,ACTUAL,,,,2024-09-16,2024-10-15,ACTUAL,2021-09-13,ACTUAL,2021-09-13,2024-09,2024-09-30,2023-06-26,ACTUAL,2023-06-26,2023-06-26,ACTUAL,2023-06-26,,INTERVENTIONAL,,Full Analysis Set (FAS) included all participants who received at least 1 dose of ALXN1840 or SoC treatment.,Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease,"A Multicenter, Randomized, Controlled, Open-label, Rater-blinded Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease",TERMINATED,,PHASE3,40.0,ACTUAL,"Alexion Pharmaceuticals, Inc.","Due to early termination of the study, data for the efficacy endpoints were not collected.",2.0,,Sponsor decision to terminate the program,,,,,t,t,f,,,,,,,,,,,2024-10-17 04:21:56.486553,2024-10-17 04:21:56.486553,INDUSTRY,,,,,,,2023,0.0
NCT04746963,,2021-02-05,2024-01-29,,2024-03-20,2021-02-09,2021-02-10,ACTUAL,2024-03-20,2024-03-22,ACTUAL,,,,2024-03-20,2024-03-22,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2024-03,2024-03-31,2022-10-01,ACTUAL,2022-10-01,2022-10-01,ACTUAL,2022-10-01,,INTERVENTIONAL,SHASTA,,Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration,Phase 1/2a Study of the Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD),TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,"AsclepiX Therapeutics, Inc.",,3.0,,Adverse Events,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,INDUSTRY,,,,,,,2022,0.0
NCT02250651,,2014-09-23,2021-04-29,2019-08-20,2021-07-06,2014-09-25,2014-09-26,ESTIMATED,2021-07-06,2021-07-28,ACTUAL,2019-08-20,2019-08-28,ACTUAL,2021-07-06,2021-07-28,ACTUAL,2014-12-15,ACTUAL,2014-12-15,2021-06,2021-06-30,2020-07-22,ACTUAL,2020-07-22,2018-10-25,ACTUAL,2018-10-25,,INTERVENTIONAL,,Intent-to-treat (ITT) Population included all randomized participants.,Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension,The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension,COMPLETED,,PHASE3,528.0,ACTUAL,Allergan,,3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,,,,,,2020,1.0
NCT04243681,,2019-08-14,,,2020-10-20,2020-01-24,2020-01-28,ACTUAL,,,,,,,2020-10-20,2020-10-22,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2020-01,2020-01-31,2020-09-01,ACTUAL,2020-09-01,2020-08-01,ACTUAL,2020-08-01,,INTERVENTIONAL,,,Combination of Autologous MSC and HSC Infusion in Patients With Decompensated Cirrhosis,Combination of Autologous Mesenchymal and Hematopoietic Stem Cell Infusion in Patients With Decompensated Cirrhosis: A Pilot Study,COMPLETED,,PHASE4,5.0,ACTUAL,"Asian Institute of Gastroenterology, India",,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,OTHER,,,,,,,2020,1.0
NCT03658616,,2018-09-03,,,2023-04-27,2018-09-03,2018-09-05,ACTUAL,,,,,,,2023-04-27,2023-04-28,ACTUAL,2018-09-18,ACTUAL,2018-09-18,2023-04,2023-04-30,2022-02-02,ACTUAL,2022-02-02,2021-11-02,ACTUAL,2021-11-02,,INTERVENTIONAL,,,Assessment of Efficacy and Safety of Topical Administration of 1% Glycopyrronium Bromide (GPB) in Patients With Primary Axillary Hyperhidrosis and the Assessment of Long-term Efficacy and Safety of Topical Administration of 1% GPB Cream in Patients With Primary Axillary Hyperhidrosis.,"Combined Randomized, Double-blind, Dose-confirming Phase 3a Study in Parallel Design to Assess the Efficacy and Safety of Topical 4-week Treatment With 1% GPB Cream vs Placebo and Open-label Phase 3b Study to Assess Long-term Efficacy and Safety in Patients With Primary Axillary Hyperhidrosis Treated With 1% GPB Cream",COMPLETED,,PHASE3,518.0,ACTUAL,Dr. August Wolff GmbH & Co. KG Arzneimittel,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,,,,,,2022,1.0
NCT05456269,,2022-07-04,,,2023-09-29,2022-07-08,2022-07-13,ACTUAL,,,,,,,2023-09-29,2023-10-03,ACTUAL,2022-07-29,ACTUAL,2022-07-29,2023-09,2023-09-30,2023-08-31,ACTUAL,2023-08-31,2023-08-31,ACTUAL,2023-08-31,,INTERVENTIONAL,BISECT,,A Study of Bisantrene Combined With Cytarabine or With Decitabine for Adult Subjects With Extramedullary AML and MDS,An Open-label Two Strata Study of Bisantrene in Combination With Cytarabine Arabinoside or Bisantrene in Combination With Oral Decitabine/Cedazuridine for the Treatment of Acute Myeloid Leukemia Patients With Extramedullary Disease,WITHDRAWN,,PHASE1,0.0,ACTUAL,Race Oncology Ltd,,2.0,,commercial reason,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,INDUSTRY,,,,,,,2023,0.0
NCT03600818,,2018-07-17,2022-05-17,,2022-05-17,2018-07-17,2018-07-26,ACTUAL,2022-05-17,2022-06-10,ACTUAL,,,,2022-05-17,2022-06-10,ACTUAL,2018-10-09,ACTUAL,2018-10-09,2022-05,2022-05-31,2021-05-19,ACTUAL,2021-05-19,2021-05-19,ACTUAL,2021-05-19,,INTERVENTIONAL,,Analysis was performed on randomized population.,Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica,"A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica",TERMINATED,,PHASE3,118.0,ACTUAL,Sanofi,"Protracted recruitment timeline exacerbated by COVID-19 pandemic led to pre-mature termination of study, resulting in a change in the total expected number of participants and change in the statistical significance level.",2.0,,Protracted recruitment timeline exacerbated by COVID-19 pandemic,f,,,,f,t,f,,,,,,,,https://vivli.org,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,INDUSTRY,,,,,,,2021,0.0
NCT04563702,,2020-09-21,,,2024-06-20,2020-09-23,2020-09-24,ACTUAL,,,,,,,2024-06-20,2024-06-21,ACTUAL,2020-09-21,ACTUAL,2020-09-21,2022-09,2022-09-30,2021-10-10,ACTUAL,2021-10-10,2021-10-10,ACTUAL,2021-10-10,,INTERVENTIONAL,,,Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults and Boost (VXA-CoV2-1.1-S) at 1 Year Post Initial Vaccination in Subset of Subjects,"A Phase 1 Open-Label, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Vaccine (VXA-CoV2-1) Expressing a SARS-CoV-2 Antigen and dsRNA Adjuvant Administered Orally to Healthy Adult Volunteers VXA-CoV2-1.1-S Boost Substudy: Boost at 1 Year Post Initial Vaccination With an Adenoviral-Vector Based Vaccine VXA-CoV2-1.1-S Expressing a SARS-CoV-2 S Protein in a Subset of Subjects",COMPLETED,,PHASE1,35.0,ACTUAL,Vaxart,,2.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,A plan on how to share individual subject's outcomes will be defined within the next few months.,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,INDUSTRY,,,,,,,2021,1.0
NCT02419105,,2015-03-30,,,2020-06-16,2015-04-13,2015-04-17,ESTIMATED,,,,,,,2020-06-16,2020-06-18,ACTUAL,2015-09,,2015-09-30,2020-06,2020-06-30,2020-06,ACTUAL,2020-06-30,2020-05,ACTUAL,2020-05-31,,INTERVENTIONAL,T&D,,Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors,"Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors. Double Blind, 2x2 Factorial, Randomized Placebo--Controlled Clinical Trial",TERMINATED,,PHASE3,91.0,ACTUAL,University of Zurich,,4.0,,Delayed recruitment mainly due to a screening to inclusion rate much lower than expected. Due to the delayed recruitment IMP reached the end of its shelf life.,f,,,,f,,,,,,,,,,,,,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,OTHER,,,,,,,2020,0.0
NCT04782661,,2021-02-16,,,2021-12-14,2021-03-03,2021-03-04,ACTUAL,,,,,,,2021-12-14,2022-01-05,ACTUAL,2022-03-01,ESTIMATED,2022-03-01,2021-12,2021-12-31,2022-09-23,ESTIMATED,2022-09-23,2022-05-09,ESTIMATED,2022-05-09,,INTERVENTIONAL,,,A Study of JNJ-70075200 in Healthy Participants,"A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of JNJ-70075200 in Healthy Participants",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Janssen Research & Development, LLC",,3.0,,Program terminated prior to enrolling subjects,f,,,,f,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,INDUSTRY,,,,,,,2022,0.0
NCT04453371,,2020-06-26,,,2021-03-10,2020-06-30,2020-07-01,ACTUAL,,,,,,,2021-03-10,2021-03-12,ACTUAL,2020-10-15,ESTIMATED,2020-10-15,2021-03,2021-03-31,2021-02-15,ESTIMATED,2021-02-15,2021-01-15,ESTIMATED,2021-01-15,,INTERVENTIONAL,AtTAC,,Impact of Tissue Plasminogen Activator (tPA) Treatment for an Atypical Acute Respiratory Distress Syndrome (COVID-19),Tissue Plasminogen Activator (tPA) Treatment for an Atypical Acute Respiratory Distress Syndrome (Microvascular COVID-19 Lung Vessels Obstructive Thromboinflammatory Syndrome (MicroCLOTS): A Multicentral Randomized Trial (AtTAC-trial),WITHDRAWN,,PHASE3,0.0,ACTUAL,Negovsky Reanimatology Research Institute,,2.0,,Our local committee has denied the approval request,f,,,,t,f,f,,,,,,,,,,,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,OTHER_GOV,,,,,,,2021,0.0
NCT04525898,,2020-02-12,,,2021-12-06,2020-08-21,2020-08-25,ACTUAL,,,,,,,2021-12-06,2021-12-21,ACTUAL,2019-10-09,ACTUAL,2019-10-09,2020-08,2020-08-31,2021-02-01,ACTUAL,2021-02-01,2021-02-01,ACTUAL,2021-02-01,,INTERVENTIONAL,,,Intraoperative Methadone for Postoperative Pain Control After Thoracic Surgery,Intraoperative Methadone for Postoperative Pain Control After Thoracic Surgery,TERMINATED,,PHASE4,40.0,ACTUAL,NorthShore University HealthSystem,,2.0,,Investigator left institution,f,,,,f,t,f,,,f,,,,,,NO,Data not to be shared,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,OTHER,,,,,,,2021,0.0
NCT04573777,,2020-09-28,2022-11-14,,2023-02-16,2020-09-28,2020-10-05,ACTUAL,2023-02-16,2023-03-15,ACTUAL,,,,2023-02-16,2023-03-15,ACTUAL,2021-04-23,ACTUAL,2021-04-23,2023-02,2023-02-28,2021-12-16,ACTUAL,2021-12-16,2021-12-16,ACTUAL,2021-12-16,,INTERVENTIONAL,RISER,,Reducing Intracranial atheroSclErosis With Repatha,Reducing Intracranial atheroSclErosis With Repatha,TERMINATED,,PHASE4,10.0,ACTUAL,"University of California, Los Angeles",,1.0,,Funding Discontinued,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,OTHER,,,,,,,2021,0.0
NCT03476239,,2018-03-12,2020-07-14,,2023-02-05,2018-03-22,2018-03-26,ACTUAL,2020-08-25,2020-09-14,ACTUAL,,,,2023-02-05,2023-02-08,ACTUAL,2017-10-18,ACTUAL,2017-10-18,2023-02,2023-02-28,2021-04-08,ACTUAL,2021-04-08,2019-08-21,ACTUAL,2019-08-21,,INTERVENTIONAL,,Participants enrolled in the study who received at least 1 infusion of blinatumomab.,Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL),"An Open-label, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)",COMPLETED,,PHASE3,121.0,ACTUAL,Amgen,,1.0,,,f,,,,f,f,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,INDUSTRY,,,,,,,2021,1.0
NCT05116969,,2021-10-20,,,2022-02-02,2021-11-02,2021-11-11,ACTUAL,,,,,,,2022-02-02,2022-02-17,ACTUAL,2021-11-24,ESTIMATED,2021-11-24,2022-02,2022-02-28,2022-11-29,ESTIMATED,2022-11-29,2022-11-29,ESTIMATED,2022-11-29,,INTERVENTIONAL,,,A Phase 1 Study of PTX-35 in Healthy Volunteers,"A Phase 1, Single Dose-Escalation and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous PTX-35 Adminsitration in Healthy Volunteers",WITHDRAWN,,PHASE1,0.0,ACTUAL,Heat Biologics,,7.0,,Sponsor withdrew submission to Human Research Ethics Committee as it evaluates the need for healthy volunteer data for development plan.,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,INDUSTRY,,,,,,,2022,0.0
NCT05602727,,2022-10-27,2024-09-20,,2024-09-20,2022-10-27,2022-11-02,ACTUAL,2024-09-20,2024-10-15,ACTUAL,,,,2024-09-20,2024-10-15,ACTUAL,2022-12-02,ACTUAL,2022-12-02,2024-09,2024-09-30,2023-09-27,ACTUAL,2023-09-27,2023-09-27,ACTUAL,2023-09-27,,INTERVENTIONAL,,,Efficacy and Safety of MK-1942 as an Adjunct Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia (MK-1942-008),"A Phase 2a/2b Randomized, Placebo-Controlled Clinical Study To Evaluate The Safety And Efficacy Of MK-1942 As Adjunctive Therapy In Participants With Mild To Moderate Alzheimer's Disease Dementia",TERMINATED,,PHASE2,99.0,ACTUAL,Merck Sharp & Dohme LLC,,3.0,,Voluntarily terminated due to benefit/risk assessment,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-17 04:21:56.486553,2024-10-17 04:21:56.486553,INDUSTRY,,,,,,,2023,0.0
NCT01011777,,2009-11-10,,,2020-01-24,2009-11-10,2009-11-11,ESTIMATED,,,,,,,2020-01-24,2020-01-28,ACTUAL,2017-02-01,ACTUAL,2017-02-01,2020-01,2020-01-31,2020-01-23,ACTUAL,2020-01-23,2020-01-23,ACTUAL,2020-01-23,,INTERVENTIONAL,MDC,,Muscle Derived Cell Therapy for Bladder Exstrophy Epispadias Induced Incontinence,Phase I Study of Endoscopically Injected Muscle Derived Cells in Participants With Exstrophy-epispadias Complex Related Urinary Incontinence,TERMINATED,,PHASE1,2.0,ACTUAL,Johns Hopkins University,,1.0,,Due to participants withdrawal prior to anticipated end of study.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,OTHER,,,,,,,2020,0.0
NCT05193370,,2021-12-09,,,2024-03-12,2022-01-02,2022-01-14,ACTUAL,,,,,,,2024-03-12,2024-03-15,ACTUAL,2022-01-03,ESTIMATED,2022-01-03,2024-03,2024-03-31,2022-11-30,ESTIMATED,2022-11-30,2022-11-30,ESTIMATED,2022-11-30,,INTERVENTIONAL,,,Angiotensin II vs. Vasopressin in Septic Shock,A Randomized Controlled Pilot Trial of Angiotensin II Versus Vasopressin as Second-line Vasopressor in the Treatment of Septic Shock,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of New Mexico,,2.0,,Funding and protocol changes. Replaced with new pilot trial.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 08:59:03.832328,2024-10-15 08:59:03.832328,OTHER,,,,,,,2022,0.0
NCT04244825,,2020-01-03,,,2021-03-02,2020-01-25,2020-01-28,ACTUAL,,,,,,,2021-03-02,2021-03-04,ACTUAL,2019-12-15,ACTUAL,2019-12-15,2021-03,2021-03-31,2020-11-05,ACTUAL,2020-11-05,2020-09-14,ACTUAL,2020-09-14,,INTERVENTIONAL,,,"Safety, Pharmacodynamics, and Pharmacokinetics of Orally Administered BLD-2660 in Subjects With IPF","A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacodynamics, Pharmacokinetics, and Safety of BLD-2660 Administered Orally in Subjects With Idiopathic Pulmonary Fibrosis",WITHDRAWN,,PHASE2,0.0,ACTUAL,Blade Therapeutics,,8.0,,Withdrawn due to concerns for patient safety during COVID-19 crisis,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,INDUSTRY,,,,,,,2020,0.0
NCT04538352,,2020-08-29,2024-05-13,,2024-07-23,2020-08-29,2020-09-04,ACTUAL,2024-07-23,2024-07-29,ACTUAL,,,,2024-07-23,2024-07-29,ACTUAL,2021-01-18,ACTUAL,2021-01-18,2024-07,2024-07-31,2023-11-01,ACTUAL,2023-11-01,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,TRANSITION-T2D,Individual participants who were randomized to the two arms of the study,Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D,Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With Type-2 Diabetes Mellitus (TRANSITION-T2D) A Prospective Randomized Controlled Trial,COMPLETED,,PHASE4,60.0,ACTUAL,The Cleveland Clinic,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,OTHER,,,,,,,2023,1.0
NCT05325164,,2022-04-05,,,2022-12-01,2022-04-05,2022-04-13,ACTUAL,,,,,,,2022-12-01,2022-12-05,ACTUAL,2022-09,ESTIMATED,2022-09-30,2022-12,2022-12-31,2023-09,ESTIMATED,2023-09-30,2023-08,ESTIMATED,2023-08-31,,INTERVENTIONAL,METHADOPT,,Methadone for 'Adenocarcinopathic' Pain Treatment,Methadone for 'Adenocarcinopathic' Pain Treatment: Methadone vs. Morphine Vanguard RCT,WITHDRAWN,,PHASE3,0.0,ACTUAL,Ottawa Hospital Research Institute,,2.0,,"Trial not started; change in Sponsor and Principal Investigator, trial to be registered again by new Sponsor/Investigator if it is started.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,OTHER,,,,,,,2023,0.0
NCT04912063,,2021-05-28,,,2024-02-23,2021-05-28,2021-06-03,ACTUAL,,,,,,,2024-02-23,2024-02-26,ACTUAL,2021-06-25,ACTUAL,2021-06-25,2024-02,2024-02-29,2023-05-09,ACTUAL,2023-05-09,2023-05-09,ACTUAL,2023-05-09,,INTERVENTIONAL,,,Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome,A Phase 1b Dose Escalation Study of Lemzoparlimab in Combination With Venetoclax and/or Azacitidine in Subjects With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS),TERMINATED,,PHASE1,40.0,ACTUAL,AbbVie,,7.0,,Strategic considerations,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,,,,,,2023,0.0
NCT02591615,,2015-10-20,2022-08-18,,2022-11-28,2015-10-28,2015-10-29,ESTIMATED,2022-11-28,2022-12-28,ACTUAL,,,,2022-11-28,2022-12-28,ACTUAL,2016-03,ACTUAL,2016-03-31,2022-11,2022-11-30,2020-07-04,ACTUAL,2020-07-04,2019-01-04,ACTUAL,2019-01-04,,INTERVENTIONAL,,,Optimal Sequencing of Pembrolizumab (MK-3475) and Standard Platinum-based Chemotherapy in First-Line NSCLC,Randomized Phase II Trial Evaluating the Optimal Sequencing of PD-1 Inhibition With Pembrolizumab (MK-3475) and Standard Platinum-based Chemotherapy in Patients With Chemotherapy Naive Stage IV Non-small Cell Lung Cancer,COMPLETED,,PHASE2,91.0,ACTUAL,"Alliance Foundation Trials, LLC.",,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,OTHER,,,,,,,2020,1.0
NCT04749615,,2021-02-05,2024-02-22,,2024-05-23,2021-02-08,2021-02-11,ACTUAL,2024-05-23,2024-06-18,ACTUAL,,,,2024-05-23,2024-06-18,ACTUAL,2020-12-17,ACTUAL,2020-12-17,2024-05,2024-05-31,2022-07-01,ACTUAL,2022-07-01,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,,,Does PAI Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving ACB & IPACK?,"Does Periarticular Injection (PAI) Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving Adductor Canal Block and Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee (ACB&IPACK)? A Blinded, Randomized Controlled Trial.",COMPLETED,,PHASE4,94.0,ACTUAL,"Hospital for Special Surgery, New York",,2.0,,,f,,,,,t,f,,,t,,,Beginning 9 months and ending 36 months following article publication.,Investigators whose proposed use of the data has been approved by an Independent review committee (learned intermediary) identified for this purpose and who have signed a DUA.,,YES,"Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices).",2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,OTHER,,,,,,,2022,1.0
NCT04083222,,2019-09-06,2022-12-21,,2022-12-21,2019-09-06,2019-09-10,ACTUAL,2022-12-21,2023-01-18,ACTUAL,,,,2022-12-21,2023-01-18,ACTUAL,2019-11-13,ACTUAL,2019-11-13,2022-12,2022-12-31,2020-07-20,ACTUAL,2020-07-20,2020-07-20,ACTUAL,2020-07-20,,INTERVENTIONAL,,Safety set included all participants who were randomized and received at least 1 dose of study drug.,"A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx","A Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx, an Antisense Inhibitor Administered Subcutaneously for 8 Weeks to Hypertensive Subjects With Uncontrolled Blood Pressure",COMPLETED,,PHASE2,26.0,ACTUAL,"Ionis Pharmaceuticals, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,INDUSTRY,,,,,,,2020,1.0
NCT01953692,,2013-09-26,2021-06-15,,2021-08-02,2013-09-26,2013-10-01,ESTIMATED,2021-06-15,2021-07-12,ACTUAL,,,,2021-08-02,2021-08-04,ACTUAL,2013-11-22,ACTUAL,2013-11-22,2021-07,2021-07-31,2020-06-26,ACTUAL,2020-06-26,2020-06-26,ACTUAL,2020-06-26,,INTERVENTIONAL,,All participants who received at least one dose of study treatment.,A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013/KEYNOTE-013),A Phase Ib Multi-Cohort Trial of MK-3475 (Pembrolizumab) in Subjects With Hematologic Malignancies,COMPLETED,,PHASE1,197.0,ACTUAL,Merck Sharp & Dohme LLC,Enrollment of participants into Cohort 5 of this study was discontinued after the Food and Drug Administration (FDA) implemented a clinical hold after determining the risks of pembrolizumab + lenalidomide outweighed any potential benefit.,9.0,,,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,,,,,,2020,1.0
NCT03515707,,2018-04-23,,,2021-01-27,2018-04-23,2018-05-03,ACTUAL,,,,,,,2021-01-27,2021-02-01,ACTUAL,2018-07-10,ACTUAL,2018-07-10,2021-01,2021-01-31,2022-07-30,ESTIMATED,2022-07-30,2022-04-15,ESTIMATED,2022-04-15,,INTERVENTIONAL,,,Stem Cell Transplant to Treat Patients With Favorable or Intermediate Risk Minimal Residual Disease Negative Acute Myeloid Leukemia,Autologous Transplant as Treatment for Favorable or Intermediate Risk MRD-Negative AML Patients After Initial Induction Therapy,WITHDRAWN,,PHASE2,0.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,PI recommended closure,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,OTHER,,,,,,,2022,0.0
NCT04421664,,2020-06-05,,,2024-10-09,2020-06-05,2020-06-09,ACTUAL,,,,,,,2024-10-09,2024-10-15,ACTUAL,2020-03-25,ACTUAL,2020-03-25,2022-04,2022-04-30,2020-08-17,ACTUAL,2020-08-17,2020-08-17,ACTUAL,2020-08-17,,INTERVENTIONAL,,,Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada),Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada),TERMINATED,,PHASE3,70.0,ACTUAL,McGill University Health Centre/Research Institute of the McGill University Health Centre,,2.0,,Request of Health Canada after publication of https://doi.org/10.7326/M20-4207,f,,,,t,t,f,,,f,,,At time of publication,To be publicly provided,,YES,De-identified dataset will be included with publication.,2024-10-17 04:21:56.486553,2024-10-17 04:21:56.486553,OTHER,,,,,,,2020,0.0
NCT04854499,,2021-04-19,,,2024-10-11,2021-04-19,2021-04-22,ACTUAL,,,,,,,2024-10-11,2024-10-15,ACTUAL,2021-09-07,ACTUAL,2021-09-07,2024-10,2024-10-31,2024-10-02,ACTUAL,2024-10-02,2024-10-02,ACTUAL,2024-10-02,,INTERVENTIONAL,ELEVATE HNSCC,,Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma,A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma,TERMINATED,,PHASE2,193.0,ACTUAL,Gilead Sciences,,8.0,,Sponsor decision to terminate study,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 04:21:56.486553,2024-10-17 04:21:56.486553,INDUSTRY,,,,,,,2024,0.0
NCT04329403,,2020-03-30,,,2020-06-24,2020-03-30,2020-04-01,ACTUAL,,,,,,,2020-06-24,2020-06-26,ACTUAL,2020-07,ESTIMATED,2020-07-31,2020-06,2020-06-30,2021-05,ESTIMATED,2021-05-31,2021-01,ESTIMATED,2021-01-31,,INTERVENTIONAL,,,Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%,"Randomized, Double Blind, Placebo Controlled, Parallel Group Design, Three Arm, Multicentric Study to Evaluate the Efficacy and Safety of Topical Adapalene Gel, 0.1 % in Healthy Males and Nonpregnant Female Subjects With Acne Vulgaris",WITHDRAWN,,PHASE3,0.0,ACTUAL,Aurobindo Pharma Ltd,,3.0,,Market reasons,f,,,,,t,f,,,t,,,,,,,,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,INDUSTRY,,,,,,,2021,0.0
NCT04896541,,2021-02-26,,,2022-06-24,2021-05-20,2021-05-21,ACTUAL,,,,,,,2022-06-24,2022-06-27,ACTUAL,2021-03-16,ACTUAL,2021-03-16,2022-06,2022-06-30,2022-06-14,ACTUAL,2022-06-14,2022-06-14,ACTUAL,2022-06-14,,INTERVENTIONAL,,,"Phase I Double-blind, Placebo-controlled Study of AZD7442","A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7442 in Healthy Japanese Participants",COMPLETED,,PHASE1,40.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indeed that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,INDUSTRY,,,,,,,2022,1.0
NCT04265534,,2020-02-07,,2022-09-15,2022-09-15,2020-02-10,2020-02-11,ACTUAL,,,,2022-09-15,2022-09-21,ACTUAL,2022-09-15,2022-09-21,ACTUAL,2020-07-24,ACTUAL,2020-07-24,2022-09,2022-09-30,2022-02-09,ACTUAL,2022-02-09,2021-11-05,ACTUAL,2021-11-05,,INTERVENTIONAL,KEAPSAKE,,"KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC","A Phase 2 Randomized, Multicenter, Double-Blind Study of the Glutaminase Inhibitor Telaglenastat With Pembrolizumab and Chemotherapy Versus Placebo With Pembrolizumab and Chemotherapy in First-Line, Metastatic KEAP1/NRF2-Mutated, Nonsquamous, Non-Small Cell Lung Cancer (NSCLC)",TERMINATED,,PHASE2,40.0,ACTUAL,"Calithera Biosciences, Inc",,2.0,,Lack of Clinical Benefit,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,INDUSTRY,,,,,,,2022,0.0
NCT05564429,,2022-09-29,2024-04-23,,2024-06-14,2022-09-30,2022-10-03,ACTUAL,2024-06-14,2024-07-09,ACTUAL,,,,2024-06-14,2024-07-09,ACTUAL,2023-02-02,ACTUAL,2023-02-02,2024-01,2024-01-31,2024-01-30,ACTUAL,2024-01-30,2023-05-09,ACTUAL,2023-05-09,,INTERVENTIONAL,,,[18F]SF12051 for Imaging the 18-kDa Translocator Protein (TSPO) in Brain and Whole Body of Healthy Subjects,Assessment of [18F]SF12051 for Imaging the 18-kDa Translocator Protein (TSPO) in Brain and Whole Body of Healthy Subjects,TERMINATED,,PHASE1,10.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,due to futility,f,,,,,t,f,,,,,,18 months after closure of protocol,BTRIS,,YES,.The results will be submitted to ClinicalTrials.gov,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,NIH,,,,,,,2024,0.0
NCT04379024,,2020-05-03,,,2021-10-22,2020-05-06,2020-05-07,ACTUAL,,,,,,,2021-10-22,2021-10-29,ACTUAL,2020-06-01,ACTUAL,2020-06-01,2021-03,2021-03-31,2021-07-31,ACTUAL,2021-07-31,2021-07-30,ACTUAL,2021-07-30,,INTERVENTIONAL,,,Pilot Study of Effects of Duavee® on Imaging and Blood Biomarkers In Women With Menopausal Symptoms,Pilot Study of Effects of Duavee® on Imaging and Blood Biomarkers In Women With Menopausal Symptoms at Increased Risk for Breast Cancer,TERMINATED,,EARLY_PHASE1,11.0,ACTUAL,University of Kansas Medical Center,,2.0,,Study agent no longer available,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,OTHER,,,,,,,2021,0.0
NCT02343679,,2014-12-03,,,2017-01-30,2015-01-16,2015-01-22,ESTIMATED,,,,,,,2017-01-30,2017-02-01,ESTIMATED,2015-05,,2015-05-31,2017-01,2017-01-31,2022-10,ESTIMATED,2022-10-31,2020-10,ESTIMATED,2020-10-31,,INTERVENTIONAL,,,Novartis PhII Ceritinib (LDK378) in R/R ALK+ Hem Malignancies,"A Phase II Study of the ALK Inhibitor, Ceritinib (LDK378), in Relapsed/Refractory ALK+ Hematologic Malignancies",WITHDRAWN,,PHASE2,0.0,ACTUAL,Duke University,,1.0,,No accrual due to rarity of disease.,f,,,,f,,,,,,,,,,,,,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,OTHER,,,,,,,2022,0.0
NCT03811028,,2018-12-17,2021-12-07,,2022-02-02,2019-01-18,2019-01-22,ACTUAL,2022-02-02,2022-02-25,ACTUAL,,,,2022-02-02,2022-02-25,ACTUAL,2019-01-19,ACTUAL,2019-01-19,2021-12,2021-12-31,2021-05-07,ACTUAL,2021-05-07,2021-04-30,ACTUAL,2021-04-30,,INTERVENTIONAL,,,"A Study to Assess the Safety, Tolerability, and Efficacy of Long-term SOBI003 Treatment in Pediatric MPS IIIA Patients","An Open, Single-arm, Multicenter Extension Study to Assess the Safety, Tolerability, and Efficacy of Long-term SOBI003 Treatment in Pediatric MPS IIIA Patients",COMPLETED,,PHASE1/PHASE2,6.0,ACTUAL,Swedish Orphan Biovitrum,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,INDUSTRY,,,,,,,2021,1.0
NCT03169894,,2017-05-24,2022-09-07,,2023-07-27,2017-05-25,2017-05-30,ACTUAL,2023-07-27,2024-02-26,ACTUAL,,,,2023-07-27,2024-02-26,ACTUAL,2017-07-14,ACTUAL,2017-07-14,2023-07,2023-07-31,2021-10-12,ACTUAL,2021-10-12,2021-09-14,ACTUAL,2021-09-14,,INTERVENTIONAL,,Safety Analysis Set,"Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis","Phase Ib Escalating Dose, Open-Label, Signal-Finding Study to Evaluate the Safety, Tolerability, and Short-Term Efficacy of the Anti-Light Monoclonal Antibody MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis Who Previously Failed Treatment With an Anti-TNFα Agent",TERMINATED,,PHASE1,8.0,ACTUAL,"Avalo Therapeutics, Inc.","This was an open label study, exploratory in nature, without a placebo control group, and as such, limits the interpretation of the study data.",1.0,,Strategic reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,,,,,,2021,0.0
NCT04730323,,2021-01-26,,,2021-01-28,2021-01-28,2021-01-29,ACTUAL,,,,,,,2021-01-28,2021-01-29,ACTUAL,2020-05-12,ACTUAL,2020-05-12,2021-01,2021-01-31,2020-06-12,ACTUAL,2020-06-12,2020-06-12,ACTUAL,2020-06-12,,INTERVENTIONAL,,,TOCILIZUMAB - An Option for Patients With COVID-19 Associated Cytokine Release Syndrome; A Single Center Experience,TOCILIZUMAB - An Option for Patients With COVID-19 Associated Cytokine Release Syndrome; A Single Center Experience,COMPLETED,,PHASE4,93.0,ACTUAL,FMH College of Medicine and Dentistry,,2.0,,,f,,,,t,t,f,,,t,,,"Whenever will be asked to, within few days",Only officials can access the data,,YES,IPD can be shared with researchers in future too,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,OTHER,,,,,,,2020,1.0
NCT04164758,,2019-11-13,2021-09-21,,2021-09-21,2019-11-13,2019-11-15,ACTUAL,2021-09-21,2021-10-14,ACTUAL,,,,2021-09-21,2021-10-14,ACTUAL,2019-10-23,ACTUAL,2019-10-23,2021-09,2021-09-30,2020-09-25,ACTUAL,2020-09-25,2020-09-25,ACTUAL,2020-09-25,,INTERVENTIONAL,,"Randomized Analysis set, i.e. all randomized patients",Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine,"A Pilot Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine",TERMINATED,,PHASE2,11.0,ACTUAL,ACADIA Pharmaceuticals Inc.,"In March 2020, recruitment of new patients was paused due to the emerging coronavirus disease 2019 (COVID-19) pandemic. It was restarted in Jun 2020 and paused again in Aug 2020. Subsequently, no further patients were enrolled. On 24 Sep 2020, the sponsor decided to permanently stop the study.",3.0,,Study enrollment impacted by COVID-19 pandemic and Sponsor terminated for business reasons,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,,,,,,2020,0.0
NCT03992872,,2019-06-18,2024-08-07,2021-12-15,2024-09-24,2019-06-18,2019-06-20,ACTUAL,2024-09-24,2024-10-16,ESTIMATED,,2024-10-16,ESTIMATED,2024-09-24,2024-10-16,ESTIMATED,2019-11-20,ACTUAL,2019-11-20,2024-09,2024-09-30,2021-01-19,ACTUAL,2021-01-19,2021-01-19,ACTUAL,2021-01-19,,INTERVENTIONAL,WRAIR,,Phase 2 Open-label Study of Alum-adjuvanted Chikungunya Virus-like Particle Vaccine (PXVX0317),A Phase 2 Open-label Study to Assess the Safety and Immunogenicity of an Alum-adjuvanted Chikungunya Virus-like Particle Vaccine (PXVX0317) in Prior Recipients of Other Alphavirus Vaccines Versus Alphavirus Naïve Controls.,COMPLETED,,PHASE2,60.0,ACTUAL,Bavarian Nordic,,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-17 04:21:56.486553,2024-10-17 04:21:56.486553,INDUSTRY,,,,,,,2021,1.0
NCT04408924,,2020-05-28,2023-04-27,,2024-05-30,2020-05-28,2020-05-29,ACTUAL,2023-04-27,2023-05-24,ACTUAL,,,,2024-05-30,2024-06-25,ACTUAL,2021-01-20,ACTUAL,2021-01-20,2024-05,2024-05-31,2023-06-02,ACTUAL,2023-06-02,2022-04-27,ACTUAL,2022-04-27,,INTERVENTIONAL,CYCLONE 1,All participants who received at least one dose of the study drug.,Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer,CYCLONE 1: A Phase 2 Study of Abemaciclib in Metastatic Castration-Resistant Prostate Cancer Patients Previously Treated With a Novel Hormonal Agent and Taxane-based Chemotherapy,COMPLETED,,PHASE2,44.0,ACTUAL,Eli Lilly and Company,,1.0,,,t,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,NCT03763604,AVAILABLE,,,,2023,0.0
NCT04840927,,2021-04-08,,,2023-11-22,2021-04-08,2021-04-12,ACTUAL,,,,,,,2023-11-22,2023-11-24,ACTUAL,2021-04-09,ACTUAL,2021-04-09,2023-11,2023-11-30,2023-05-17,ACTUAL,2023-05-17,2023-05-17,ACTUAL,2023-05-17,,INTERVENTIONAL,,,A Study to Evaluate the Relative Bioavailability of E7386 Following Oral Administration of Targeted Release (TR) Tablets Compared to an E7386 Immediate Release (IR) Tablet in Healthy Adult Participants,"An Open-Label, Single Center, Randomized, Pharmacoscintigraphic Study to Evaluate the Relative Bioavailability of E7386 Following Oral Administration of Targeted Release Tablets Compared to an E7386 Immediate Release Tablet in Healthy Adult Subjects",WITHDRAWN,,PHASE1,0.0,ACTUAL,Eisai Inc.,,2.0,,Delay in availability of IMP,f,,,,f,f,f,,,,,,,,,YES,Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,,,,,,2023,0.0
NCT04204096,,2019-12-17,,,2021-08-26,2019-12-17,2019-12-18,ACTUAL,,,,,,,2021-08-26,2021-08-27,ACTUAL,2020-02-04,ACTUAL,2020-02-04,2021-08,2021-08-31,2021-01-29,ACTUAL,2021-01-29,2020-09-11,ACTUAL,2020-09-11,,INTERVENTIONAL,,,Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III),"A Phase III, Multicenter, Observer Blind, Randomized, Controlled Study to Evaluate Immune Equivalence of Multi-dose Formulation Against Single-dose Formulation of Vi-DT Typhoid Conjugate Vaccine and Safety in Healthy Filipino......",COMPLETED,,PHASE3,1800.0,ACTUAL,International Vaccine Institute,,3.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,OTHER,,,,,,,2021,1.0
NCT05093166,,2021-09-03,,,2023-03-01,2021-10-13,2021-10-26,ACTUAL,,,,,,,2023-03-01,2023-03-03,ACTUAL,2021-11-26,ACTUAL,2021-11-26,2023-03,2023-03-31,2024-12,ESTIMATED,2024-12-31,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,HOLOUR,,Clinical Trial to Assess the Safety and Efficacy of Investigational Product in Patients Due to Hypospadias Treatment Failure,"Prospective, Open-label, Uncontrolled Pilot Clinical Trial to Assess the Safety and Efficacy of Autologous Cultured Oral Mucosa Grafts for Urethral Reconstruction in Patients Due to Hypospadias Treatment Failure",SUSPENDED,,PHASE1/PHASE2,8.0,ESTIMATED,Holostem Terapie Avanzate s.r.l.,,1.0,,Due to the current re-organization at the Sponsor site,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,INDUSTRY,,,,,,,2024,0.0
NCT03234907,,2017-07-26,2022-08-24,2021-07-27,2023-02-28,2017-07-26,2017-07-31,ACTUAL,2022-08-24,2022-09-21,ACTUAL,2021-07-27,2021-08-02,ACTUAL,2023-02-28,2023-03-01,ACTUAL,2017-08-03,ACTUAL,2017-08-03,2023-02,2023-02-28,2020-08-14,ACTUAL,2020-08-14,2020-08-14,ACTUAL,2020-08-14,,INTERVENTIONAL,,FAS for the induction phase study included all randomized participants who received any amount of blinded study drug during the Induction Phase.,Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease.,"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Crohn's Disease",COMPLETED,,PHASE3,215.0,ACTUAL,Takeda,,6.0,,,f,,,,f,t,f,,,t,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,,,,,,2020,1.0
NCT03950622,,2019-05-13,2021-02-10,,2021-03-26,2019-05-13,2019-05-15,ACTUAL,2021-02-22,2021-03-18,ACTUAL,,,,2021-03-26,2021-04-26,ACTUAL,2019-06-13,ACTUAL,2019-06-13,2021-03,2021-03-31,2020-03-30,ACTUAL,2020-03-30,2020-03-30,ACTUAL,2020-03-30,,INTERVENTIONAL,PNEU-AGE,,Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE),"A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults 50 Years of Age or Older (PNEU-AGE)",COMPLETED,,PHASE3,1205.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,,,,,,2020,1.0
NCT04824872,,2021-03-29,,,2023-02-16,2021-03-29,2021-04-01,ACTUAL,,,,,,,2023-02-16,2023-02-21,ACTUAL,2023-02,ESTIMATED,2023-02-28,2023-02,2023-02-28,2023-02,ESTIMATED,2023-02-28,2023-02,ESTIMATED,2023-02-28,,INTERVENTIONAL,,,Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults,"A Double-Blind, Placebo-Controlled, Cross-over Trial, Evaluating Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults",WITHDRAWN,,PHASE2,0.0,ACTUAL,Zealand Pharma,,6.0,,Never started,f,,,,,t,f,,,f,,,,,,,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,INDUSTRY,,,,,,,2023,0.0
NCT02214160,,2014-08-06,2021-10-11,,2023-07-28,2014-08-07,2014-08-12,ESTIMATED,2021-11-10,2021-12-08,ACTUAL,,,,2023-07-28,2023-08-01,ACTUAL,2014-12-09,ACTUAL,2014-12-09,2023-07,2023-07-31,2020-12-03,ACTUAL,2020-12-03,2020-12-03,ACTUAL,2020-12-03,,INTERVENTIONAL,,,Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD) Extension Study for Subjects Previously Enrolled in Triheptanoin Studies,An Open-label Long-Term Safety and Efficacy Extension Study in Subjects With Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD) Previously Enrolled in UX007 or Triheptanoin Studies,COMPLETED,,PHASE2,94.0,ACTUAL,Ultragenyx Pharmaceutical Inc,,1.0,,,t,,,,f,t,f,,,,,,,,,,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,NCT03773770,AVAILABLE,,,,2020,1.0
NCT05093621,,2021-10-13,2024-06-28,,2024-09-19,2021-10-13,2021-10-26,ACTUAL,2024-09-19,2024-10-15,ACTUAL,,,,2024-09-19,2024-10-15,ACTUAL,2021-02-08,ACTUAL,2021-02-08,2024-09,2024-09-30,2023-06-30,ACTUAL,2023-06-30,2023-06-30,ACTUAL,2023-06-30,,INTERVENTIONAL,TFO,,Torsemide Comparison With Furosemide for Management of Patients With Stable Heart Failure,Torsemide Comparison With Furosemide for Management of Patients With Stable Heart Failure,COMPLETED,,PHASE3,47.0,ACTUAL,Yale University,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 04:21:56.486553,2024-10-17 04:21:56.486553,OTHER,,,,,,,2023,1.0
NCT03409198,,2017-12-04,,,2024-10-09,2018-01-18,2018-01-24,ACTUAL,,,,,,,2024-10-09,2024-10-15,ACTUAL,2018-01-21,ACTUAL,2018-01-21,2024-02,2024-02-29,2022-05-11,ACTUAL,2022-05-11,2022-05-11,ACTUAL,2022-05-11,,INTERVENTIONAL,ICON,,Phase IIb Study Evaluating Immunogenic Chemotherapy Combined with Ipilimumab and Nivolumab in Breast Cancer,A Randomized Phase IIb Study Evaluating Immunogenic Chemotherapy Combined with Ipilimumab and Nivolumab in Patients with Metastatic Hormone Reseptor Positive Breast Cancer,COMPLETED,,PHASE2,82.0,ACTUAL,Oslo University Hospital,,2.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-17 04:21:56.486553,2024-10-17 04:21:56.486553,OTHER,,,,,,,2022,1.0
NCT01826877,,2013-04-04,,,2021-07-28,2013-04-04,2013-04-09,ESTIMATED,,,,,,,2021-07-28,2021-08-04,ACTUAL,2013-01-14,ACTUAL,2013-01-14,2021-07,2021-07-31,2021-05-27,ACTUAL,2021-05-27,2018-07-03,ACTUAL,2018-07-03,,INTERVENTIONAL,,,Autologous Dendritic Cells in Treating Patients With Metastatic Kidney Cancer,"A Phase I, Open Label, Dose Escalation and Cohort Expansion Study to Evaluate the Safety and Immune Response to Autologous Dendritic Cells Transduced With Ad-GMCAIX in Patients With Metastatic Renal Cell Carcinoma",COMPLETED,,PHASE1,12.0,ACTUAL,Jonsson Comprehensive Cancer Center,,1.0,,,f,,,,t,t,,,,,,,,,,,,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,OTHER,,,,,,,2021,1.0
NCT04553406,,2020-09-01,2022-02-03,,2022-02-03,2020-09-11,2020-09-17,ACTUAL,2022-02-03,2022-02-28,ACTUAL,,,,2022-02-03,2022-02-28,ACTUAL,2020-12-03,ACTUAL,2020-12-03,2021-11,2021-11-30,2021-01-28,ACTUAL,2021-01-28,2021-01-28,ACTUAL,2021-01-28,,INTERVENTIONAL,,,"Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease","A Randomized, Partially Blinded, Placebo- and Comparator-Controlled, Multicenter, Phase 2a, Dose Ranging, Proof-of-Concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SPR720 as Compared With Placebo or Standard of Care for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease",TERMINATED,,PHASE2,2.0,ACTUAL,Spero Therapeutics,,4.0,,Business decision pending resolution of clinical hold with FDA,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,,,,,,2021,0.0
NCT03438344,,2017-12-29,,,2018-11-19,2018-02-16,2018-02-19,ACTUAL,,,,,,,2018-11-19,2018-11-21,ACTUAL,2018-12,ESTIMATED,2018-12-31,2018-11,2018-11-30,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Multi-antigen CMV-Modified Vaccinia Ankara Vaccine in Reducing CMV Related Complications in Patients With Blood Cancer Undergoing Donor Stem Cell Transplant,"A Phase II Randomized, Placebo-Controlled, Multicenter Trial to Evaluate the Protective Function of a CMV-MVA Triplex Vaccine in Recipients of a Haploidentical Hematopoietic Stem Cell Transplant",WITHDRAWN,,PHASE2,0.0,ACTUAL,City of Hope Medical Center,,2.0,,PI Withdrawal,,,,,t,t,f,,,,,,,,,,,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,OTHER,,,,,,,2021,0.0
NCT03840902,,2019-02-12,2023-12-05,,2024-01-12,2019-02-12,2019-02-15,ACTUAL,2024-01-12,2024-01-16,ACTUAL,,,,2024-01-12,2024-01-16,ACTUAL,2019-04-16,ACTUAL,2019-04-16,2024-01,2024-01-31,2023-02-17,ACTUAL,2023-02-17,2023-02-17,ACTUAL,2023-02-17,,INTERVENTIONAL,,Full Analysis Set (FAS) included all participants who were randomized to study treatment.,M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC),"A Multicenter, Double Blind, Randomized, Controlled Study of M7824 With Concurrent Chemoradiation Followed by M7824 Versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants With Unresectable Stage III Non-small Cell Lung Cancer",TERMINATED,,PHASE2,153.0,ACTUAL,EMD Serono,,2.0,,"Based on recommendations by an external Independent data Monitoring Committee (IDMC), Sponsor decided to discontinue this clinical study due to a low likelihood of achieving superiority in the efficacy endpoints versus standard of care.",f,,,,t,t,f,,,,,,Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union,Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.,http://bit.ly/IPD21,YES,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21",2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,,,,,,2023,0.0
NCT02786537,,2016-05-17,2020-05-26,,2021-12-01,2016-05-25,2016-06-01,ESTIMATED,2020-10-30,2020-11-24,ACTUAL,,,,2021-12-01,2021-12-06,ACTUAL,2016-06,,2016-06-30,2021-12,2021-12-31,2020-09-02,ACTUAL,2020-09-02,2019-06-13,ACTUAL,2019-06-13,,INTERVENTIONAL,PRIORITIZE,Study participants as randomized to HCV treatment,Study of Oral Treatments for Hepatitis C,"THE PRIORITIZE STUDY: A Pragmatic, Randomized Study of Oral Regimens for Hepatitis C: Transforming Decision-Making for Patients, Providers, and Stakeholders",COMPLETED,,PHASE4,1275.0,ACTUAL,University of Florida,"This pragmatic trial allowed patients who were randomized to SOF/LDV but unable to obtain SOF/LDV (due to limitations in access from insurance, etc.) to be treated with the accessible, alternative DAA regimens. This contributed to the variance from 'as randomized' population to the 'as treated' population. Rapidly changing HCV landscape led to discontinuation of PrOD treatment regimen and modification of initial analysis plan including reduction of original sample size.",6.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,OTHER,,,,,,,2020,1.0
NCT02714205,,2016-03-11,2023-03-02,,2023-04-24,2016-03-15,2016-03-21,ESTIMATED,2023-04-24,2023-05-18,ACTUAL,,,,2023-04-24,2023-05-18,ACTUAL,2017-04-24,ACTUAL,2017-04-24,2023-04,2023-04-30,2022-04-05,ACTUAL,2022-04-05,2022-03-08,ACTUAL,2022-03-08,,INTERVENTIONAL,FRAN,,Flushing Reduction Associated With Nitrates,Flushing Reduction Associated With Nitrates,COMPLETED,,PHASE2,141.0,ACTUAL,"University of California, San Francisco",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,OTHER,,,,,,,2022,1.0
NCT04366271,,2020-04-23,,,2021-08-24,2020-04-27,2020-04-28,ACTUAL,,,,,,,2021-08-24,2021-08-27,ACTUAL,2020-05-07,ACTUAL,2020-05-07,2021-08,2021-08-31,2021-05-31,ACTUAL,2021-05-31,2020-07-31,ACTUAL,2020-07-31,,INTERVENTIONAL,MESCEL-COVID19,,Clinical Trial of Allogeneic Mesenchymal Cells From Umbilical Cord Tissue in Patients With COVID-19,Phase II Clinical Trial to Explore the Efficacy of Allogeneic Mesenchymal Cells From Umbilical Cord Tissue in Patients With Severe Pulmonary Involvement by COVID-19,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Hospital Infantil Universitario Niño Jesús, Madrid, Spain",,2.0,,Lack of funding,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,OTHER,,,,,,,2021,0.0
NCT04342156,,2020-04-08,,,2020-10-05,2020-04-09,2020-04-10,ACTUAL,,,,,,,2020-10-05,2020-10-08,ACTUAL,2020-04,ESTIMATED,2020-04-30,2020-04,2020-04-30,2020-10,ESTIMATED,2020-10-31,2020-08,ESTIMATED,2020-08-31,,INTERVENTIONAL,SHARP COVID-19,,Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19,Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19- A Cluster Randomized Controlled Trial (SHARP COVID-19 RCT),WITHDRAWN,,PHASE3,0.0,ACTUAL,Tan Tock Seng Hospital,,2.0,,The number of patients with COVID-19 in Singapore was coming down for the community and the concerns about the potential side effects particularly when the baseline ECG and serum electrolytes was not proposed.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,OTHER,,,,,,,2020,0.0
NCT03795194,,2018-07-19,2023-11-06,,2024-03-05,2019-01-03,2019-01-07,ACTUAL,2024-03-05,2024-03-08,ACTUAL,,,,2024-03-05,2024-03-08,ACTUAL,2019-05-01,ACTUAL,2019-05-01,2024-03,2024-03-31,2021-12-15,ACTUAL,2021-12-15,2021-12-15,ACTUAL,2021-12-15,,INTERVENTIONAL,,,Antibiotic Duration in Post-appendectomy Abscess,"A Prospective, Randomized Trial of Antibiotic Duration in Post-appendectomy Abscess",TERMINATED,,PHASE4,7.0,ACTUAL,Phoenix Children's Hospital,Low enrollment. Early termination leading to small number of subjects analyzed.,2.0,,Due to low enrollment.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,OTHER,,,,,,,2021,0.0
NCT03859869,,2019-02-28,2023-03-17,,2023-06-02,2019-02-28,2019-03-01,ACTUAL,2023-06-02,2023-06-05,ACTUAL,,,,2023-06-02,2023-06-05,ACTUAL,2020-02-25,ACTUAL,2020-02-25,2023-06,2023-06-30,2022-03-23,ACTUAL,2022-03-23,2022-03-23,ACTUAL,2022-03-23,,INTERVENTIONAL,,Full Analysis Set: all randomized participants who received at least 1 dose of study drug,A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI),"Creon (Pancrelipase) Therapy for Subjects With Exocrine Pancreatic Insufficiency (EPI) Due to Pancreatic Cancer: A Double-blind, Randomized, Parallel Design With 2 Dose Cohorts of Pancrelipase in Resected Pancreatic Cancer Subjects and an Open-label Single Dose Cohort in Non-resected Pancreatic Cancer Subjects",TERMINATED,,PHASE4,1.0,ACTUAL,AbbVie,This study was terminated due to low enrollment rates. The decision to terminate the study was not based on any safety or efficacy data.,3.0,,Business Considerations (difficulty with enrollment),f,,,,f,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link: https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,,,,,,2022,0.0
NCT04723394,,2021-01-14,2022-08-17,,2023-06-30,2021-01-22,2021-01-25,ACTUAL,2022-11-28,2022-12-20,ACTUAL,,,,2023-06-30,2023-07-05,ACTUAL,2021-01-28,ACTUAL,2021-01-28,2023-06,2023-06-30,2022-10-19,ACTUAL,2022-10-19,2021-08-21,ACTUAL,2021-08-21,,INTERVENTIONAL,TACKLE,Full Analysis Set - All participants randomized and dosed with IMP,Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults,"A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID-19 in Non-hospitalized Adults",COMPLETED,,PHASE3,910.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,,,,,,2022,1.0
NCT04820686,,2021-03-25,2023-09-11,,2023-10-23,2021-03-25,2021-03-29,ACTUAL,2023-10-23,2023-11-14,ACTUAL,,,,2023-10-23,2023-11-14,ACTUAL,2021-05-07,ACTUAL,2021-05-07,2023-10,2023-10-31,2023-03-30,ACTUAL,2023-03-30,2023-03-30,ACTUAL,2023-03-30,,INTERVENTIONAL,,,A Study Evaluating Treatment Regimens Containing Vebicorvir (ABI-H0731) in Participants With Chronic Hepatitis B Infection,"A Randomized Phase 2a, Multicenter, Open-Label, Multiple-Cohort Study Evaluating Regimens Containing Vebicorvir in Subjects With Chronic Hepatitis B Virus Infection",TERMINATED,,PHASE2,65.0,ACTUAL,Assembly Biosciences,"Study ABI-H0731-204 was terminated early by the study Sponsor for strategic reasons to prioritize research and development efforts on finite and curative HBV therapies. As a result, not all subjects completed Week 96 and some outcome measures were impacted.",3.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,,,,,,2023,0.0
NCT03714815,,2018-10-19,2022-10-12,,2023-09-13,2018-10-19,2018-10-22,ACTUAL,2022-10-12,2022-11-04,ACTUAL,,,,2023-09-13,2023-09-22,ACTUAL,2018-12-07,ACTUAL,2018-12-07,2023-09,2023-09-30,2021-10-12,ACTUAL,2021-10-12,2021-10-12,ACTUAL,2021-10-12,,INTERVENTIONAL,SERENADE OL,,A Long Term Study to Find Out if Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease,"A Long-term, Multicenter, Single-arm, Open-label Extension of the SERENADE Study, to Assess the Safety and Efficacy of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease",TERMINATED,,PHASE2,91.0,ACTUAL,Actelion,Limited number of efficacy parameters were assessed in an exploratory manner. Study was stopped prematurely as main double-blind study did not meet the primary efficacy outcome measure.,1.0,,the absence of a positive trend in all efficacy parameters indicates that macitentan 10 mg does not have a beneficial effect in patients with HFpEF and PVD.,f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials\\transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu",2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,,,,,,2021,0.0
NCT04201093,,2019-12-13,,,2024-07-26,2019-12-13,2019-12-17,ACTUAL,,,,,,,2024-07-26,2024-07-29,ACTUAL,2019-12-13,ACTUAL,2019-12-13,2024-07,2024-07-31,2024-06-28,ACTUAL,2024-06-28,2024-06-28,ACTUAL,2024-06-28,,INTERVENTIONAL,TEMPO-1,,Fixed-Dose Trial in Early Parkinson's Disease (PD),"A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL)",COMPLETED,,PHASE3,522.0,ACTUAL,"Cerevel Therapeutics, LLC",,3.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,INDUSTRY,,,,,,,2024,1.0
NCT03021941,,2016-09-23,,,2019-09-20,2017-01-11,2017-01-16,ESTIMATED,,,,,,,2019-09-20,2019-09-24,ACTUAL,2019-07-31,ESTIMATED,2019-07-31,2019-08,2019-08-31,2020-06-30,ESTIMATED,2020-06-30,2020-06-30,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,"Pharmacokinetics, Pharmacodynamics And Safety Study Of Elelyso(tm) In Pediatric Subjects With Type 1 Gaucher Disease","A MULTICENTER, OPEN LABEL, PHARMACOKINETICS, PHARMACODYNAMICS AND SAFETY STUDY OF ELELYSO(TM) (TALIGLUCERASE ALFA) IN PEDIATRIC SUBJECTS WITH TYPE 1 GAUCHER DISEASE",WITHDRAWN,,PHASE4,0.0,ACTUAL,Pfizer,,1.0,,"In a communication dated June 12, 2019 the FDA has released Pfizer from the Postmarketing Commitment (PMC 2767-2) that was associated with study B3031003.",f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,INDUSTRY,,,,,,,2020,0.0
NCT06638749,,2019-04-24,,,2024-10-10,2024-10-10,2024-10-15,ACTUAL,,,,,,,2024-10-10,2024-10-15,ACTUAL,2019-05-01,ESTIMATED,2019-05-01,2019-04,2019-04-30,2024-10-10,ACTUAL,2024-10-10,2020-12-01,ESTIMATED,2020-12-01,,INTERVENTIONAL,,,Effect of TXA on Blood Loss in Reverse Total Shoulder Arthroplasty,Effect of Tranexamic Acid on Blood Loss in Reverse Total Shoulder Arthroplasty,WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Kansas Medical Center,,2.0,,Administrative withdrawal-study not approved by IRB,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 04:21:56.486553,2024-10-17 04:21:56.486553,OTHER,,,,,,,2024,0.0
NCT05563168,,2022-09-30,,,2023-05-25,2022-09-30,2022-10-03,ACTUAL,,,,,,,2023-05-25,2023-05-26,ACTUAL,2023-04,ESTIMATED,2023-04-30,2023-05,2023-05-31,2024-12,ESTIMATED,2024-12-31,2024-10,ESTIMATED,2024-10-31,,INTERVENTIONAL,DICOV,,Study Evaluating Diltiazem in Combination With Standard Treatment in the Management of Patients Hospitalized With COVID-19 Pneumonia,"Multicenter, Double-blind, Randomized, Placebo-controlled Study Evaluating Diltiazem in Combination With Standard Treatment in the Management of Patients Hospitalized With COVID-19 Pneumonia - A Phase IIB, Proof of Concept Study",WITHDRAWN,,PHASE2,0.0,ACTUAL,Hospices Civils de Lyon,,2.0,,the epidemiological situation has changed considerably.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,OTHER,,,,,,,2024,0.0
NCT02713126,,2016-03-15,2023-04-03,,2023-04-03,2016-03-15,2016-03-18,ESTIMATED,2023-04-03,2023-04-26,ACTUAL,,,,2023-04-03,2023-04-26,ACTUAL,2016-09,,2016-09-30,2023-04,2023-04-30,2022-04-12,ACTUAL,2022-04-12,2022-04-12,ACTUAL,2022-04-12,,INTERVENTIONAL,INABLE,,Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training),Inorganic Nitrite to Enhance Benefits From Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF),COMPLETED,,PHASE2,92.0,ACTUAL,Mayo Clinic,Manufacturer discontinuation of the inhaled drug supply forced the investigator to modify the study and change the route of administration of sodium nitrite from inhaled to oral. The oral formulation achieved similar pharmacokinetics and therefore it was scientifically justified to combine the data.,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,OTHER,,,,,,,2022,1.0
NCT04044378,,2019-08-01,,,2020-05-15,2019-08-02,2019-08-05,ACTUAL,,,,,,,2020-05-15,2020-05-19,ACTUAL,2019-08-15,ACTUAL,2019-08-15,2020-05,2020-05-31,2022-09-30,ESTIMATED,2022-09-30,2021-09-30,ESTIMATED,2021-09-30,,INTERVENTIONAL,,,Famitinib Plus Camrelizumab & Famitinib Alone & Famitinib Plus Ifosfamide in Advanced Osteosarcoma,"Famitinib Malate (SHR1020) Plus Camrelizumab (SHR 1210) Versus Famitinib Malate Alone Versus Famitinib Malate Plus Ifosfamide Locally Advanced, Unresectable or Metastatic Osteosarcoma Progression Upon Chemotherapy: A Phase Ib/II Randomized and Controlled Dose-Escalation Trial",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Peking University People's Hospital,,3.0,,toxicity,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,OTHER,,,,,,,2022,0.0
NCT01779050,,2013-01-25,2022-08-31,,2022-10-31,2013-01-25,2013-01-29,ESTIMATED,2022-10-31,2022-11-01,ACTUAL,,,,2022-10-31,2022-11-01,ACTUAL,2013-12-19,ACTUAL,2013-12-19,2022-10,2022-10-31,2021-09-01,ACTUAL,2021-09-01,2021-09-01,ACTUAL,2021-09-01,,INTERVENTIONAL,,,Effect of Trastuzumab on Disease Free Survival in Early Stage HER2-Negative Breast Cancer Patients With ERBB2 Expressing Disseminated Tumor Cells,A Phase II Randomized Trial Evaluating the Effect of Trastuzumab on Disease Free Survival in Early Stage HER2-Negative Breast Cancer Patients With ERBB2 Expressing Bone Marrow Disseminated Tumor Cells,TERMINATED,,PHASE2,7.0,ACTUAL,Washington University School of Medicine,,2.0,,Loss of study funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,OTHER,,,,,,,2021,0.0
NCT02166905,,2014-04-21,2022-03-22,,2023-01-27,2014-06-16,2014-06-18,ESTIMATED,2023-01-27,2023-02-24,ACTUAL,,,,2023-01-27,2023-02-24,ACTUAL,2014-10-10,ACTUAL,2014-10-10,2023-01,2023-01-31,2020-08-20,ACTUAL,2020-08-20,2020-08-20,ACTUAL,2020-08-20,,INTERVENTIONAL,,"Eligible patients will be women ≥ 18 years, with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma after chemotherapy with no evidence of disease or minimal residual disease for primary or recurrent disease.","DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission","A Phase I/IIb Study of DEC205mAb-NY-ESO-1 Fusion Protein (CDX-1401) Given With Adjuvant Poly-ICLC in Combination With INCB024360 for Patients in Remission With Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen",COMPLETED,,PHASE1/PHASE2,40.0,ACTUAL,Roswell Park Cancer Institute,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,OTHER,,,,,,,2020,1.0
NCT04502693,,2020-08-04,2023-12-21,2023-09-04,2024-02-09,2020-08-04,2020-08-06,ACTUAL,2024-02-09,2024-03-05,ACTUAL,,2024-03-05,ACTUAL,2024-02-09,2024-03-05,ACTUAL,2020-08-14,ACTUAL,2020-08-14,2024-02,2024-02-29,2022-09-13,ACTUAL,2022-09-13,2022-09-13,ACTUAL,2022-09-13,,INTERVENTIONAL,,"As pre-specified in the protocol, data reported in the Baseline characteristics are presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.",Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults,"A Phase III, Randomized, Controlled, Observer-blind Study to Demonstrate Effectiveness, Immunogenicity and Safety of GSK's Meningococcal Group B and Combined ABCWY Vaccines When Administered to Healthy Adolescents and Young Adults",COMPLETED,,PHASE3,3657.0,ACTUAL,GlaxoSmithKline,,7.0,,,f,,,,f,t,f,,,t,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,INDUSTRY,,,,,,,2022,1.0
NCT04487392,,2020-07-24,,,2023-06-27,2020-07-24,2020-07-27,ACTUAL,,,,,,,2023-06-27,2023-06-29,ACTUAL,2020-12-15,ESTIMATED,2020-12-15,2020-07,2020-07-31,2021-12-30,ESTIMATED,2021-12-30,2021-09-30,ESTIMATED,2021-09-30,,INTERVENTIONAL,,,Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women.,Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women: Randomized and Controlled Trial.,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Nove de Julho,,2.0,,The student do not start the study,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,OTHER,,,,,,,2021,0.0
NCT03302234,,2017-09-26,2021-08-12,,2023-09-25,2017-10-04,2017-10-05,ACTUAL,2021-09-09,2021-09-10,ACTUAL,,,,2023-09-25,2023-09-26,ACTUAL,2017-12-14,ACTUAL,2017-12-14,2023-09,2023-09-30,2022-09-07,ACTUAL,2022-09-07,2020-09-01,ACTUAL,2020-09-01,,INTERVENTIONAL,,All randomized participants.,Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598),"A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Plus Ipilimumab vs Pembrolizumab Plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung Cancer Subjects Whose Tumors Are PD-L1 Positive (TPS ≥ 50%) (KEYNOTE-598)",COMPLETED,,PHASE3,568.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,INDUSTRY,,,,,,,2022,1.0
NCT05239975,,2022-02-14,,,2024-02-07,2022-02-14,2022-02-15,ACTUAL,,,,,,,2024-02-07,2024-02-09,ACTUAL,2022-04-25,ESTIMATED,2022-04-25,2022-02,2022-02-28,2023-02-01,ESTIMATED,2023-02-01,2022-07-01,ESTIMATED,2022-07-01,,INTERVENTIONAL,,,A Study of the Immunogenicity and Safety of SCTV01C in Population Aged ≥12 Years and Previously Vaccinated With Inactivated COVID-19 Vaccine,"A Randomized, Double-blind Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) in Population Aged ≥12 Years and Previously Vaccinated With Inactivated COVID-19 Vaccine",WITHDRAWN,,PHASE2,0.0,ACTUAL,Sinocelltech Ltd.,,2.0,,There was not a need to carry out a study in LAO any more.,f,,,,,f,f,,,,,,,,,,,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,INDUSTRY,,,,,,,2023,0.0
NCT03298867,,2017-09-27,2020-02-14,,2024-06-18,2017-09-27,2017-10-02,ACTUAL,2020-03-02,2020-03-10,ACTUAL,,,,2024-06-18,2024-07-11,ACTUAL,2017-10-04,ACTUAL,2017-10-04,2024-06,2024-06-30,2020-11-30,ACTUAL,2020-11-30,2019-02-13,ACTUAL,2019-02-13,,INTERVENTIONAL,OPTIC,,"Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study","A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating Teprotumumab (HZN-001) Treatment in Subjects With Active Thyroid Eye Disease",COMPLETED,,PHASE3,83.0,ACTUAL,Amgen,,2.0,,,f,,,,t,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,INDUSTRY,,,,,,,2020,1.0
NCT05197556,,2022-01-05,,,2024-03-18,2022-01-05,2022-01-19,ACTUAL,,,,,,,2024-03-18,2024-03-19,ACTUAL,2022-02-24,ACTUAL,2022-02-24,2022-06,2022-06-30,2023-04-04,ACTUAL,2023-04-04,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Efficacy of HSG4112 in Overweight and Obese Patients,"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, Phase 2a Clinical Trial to Evaluate the Safety and Efficacy of HSG4112 in Overweight and Obese Patients Following 12 Weeks of Oral Treatment",COMPLETED,,PHASE2,81.0,ACTUAL,Glaceum,,4.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,INDUSTRY,,,,,,,2023,1.0
NCT04523220,,2020-08-20,2023-05-05,2022-06-28,2023-07-13,2020-08-20,2020-08-21,ACTUAL,2023-07-13,2023-07-21,ACTUAL,,2023-07-21,ACTUAL,2023-07-13,2023-07-21,ACTUAL,2020-08-28,ACTUAL,2020-08-28,2023-07,2023-07-31,2022-05-30,ACTUAL,2022-05-30,2021-12-28,ACTUAL,2021-12-28,,INTERVENTIONAL,CONVERT,FAS (full analysis set): All participants randomly assigned to study intervention.,Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis,"A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study to Assess the Safety and Tolerability of Monthly Subcutaneous Administrations of a Low and High Dose Cohort of Osocimab to ESRD Patients on Regular Hemodialysis",COMPLETED,,PHASE2,704.0,ACTUAL,Bayer,,4.0,,,f,,,,t,t,f,,,,,,,,,NO,There are no current plans to share data.,2024-10-15 09:04:40.630095,2024-10-15 09:04:40.630095,INDUSTRY,,,,,,,2022,1.0
NCT02871297,,2016-08-15,2022-10-04,,2022-11-22,2016-08-15,2016-08-18,ESTIMATED,2022-11-22,2022-12-28,ACTUAL,,,,2022-11-22,2022-12-28,ACTUAL,2016-08-17,ACTUAL,2016-08-17,2022-11,2022-11-30,2022-04-19,ACTUAL,2022-04-19,2022-03-25,ACTUAL,2022-03-25,,INTERVENTIONAL,,All-patients-treated set (APTS) included all participants who took at least 1 dose of vortioxetine in this study 12712A.,"Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age","Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 18 Years of Age",TERMINATED,,PHASE3,662.0,ACTUAL,H. Lundbeck A/S,The study was terminated early based on new efficacy data from another study.,1.0,,The study was terminated based on new efficacy data from another study.,f,,,,t,,,,,,,,,,,,,2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,INDUSTRY,,,,,,,2022,0.0
NCT03560232,,2018-06-06,,,2020-09-09,2018-06-15,2018-06-18,ACTUAL,,,,,,,2020-09-09,2020-09-11,ACTUAL,2018-07-09,ACTUAL,2018-07-09,2020-09,2020-09-30,2020-02-19,ACTUAL,2020-02-19,2020-02-19,ACTUAL,2020-02-19,,INTERVENTIONAL,,,Noninferiority Comparison of Prophylactic Open Fracture Antimicrobial Regimens,A Randomized Controlled Trial Assessing Noninferiority of Three Antimicrobial Regimens for the Treatment of Grade III Open Fractures,TERMINATED,,PHASE4,17.0,ACTUAL,Mercy Health Ohio,,5.0,,Unable to recruit patients in a timely fashion and unable to recruit sufficient patients,f,,,,,t,f,,,t,,,,,,NO,,2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,OTHER,,,,,,,2020,0.0
NCT03592862,,2018-06-25,,,2019-09-30,2018-07-18,2018-07-19,ACTUAL,,,,,,,2019-09-30,2019-10-01,ACTUAL,2019-07,ESTIMATED,2019-07-31,2019-09,2019-09-30,2021-01,ESTIMATED,2021-01-31,2020-07,ESTIMATED,2020-07-31,,INTERVENTIONAL,DLB,,"A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies","A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Assess the Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies",WITHDRAWN,,PHASE2,0.0,ACTUAL,Nxera Pharma UK Limited,,4.0,,Pending investigation of an unexpected animal toxicology finding.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 06:38:30.673766,2024-10-16 06:38:30.673766,INDUSTRY,,,,,,,2021,0.0
NCT05416320,,2022-06-08,,,2023-08-28,2022-06-08,2022-06-13,ACTUAL,,,,,,,2023-08-28,2023-08-31,ACTUAL,2023-08,ESTIMATED,2023-08-31,2023-08,2023-08-31,2023-12,ESTIMATED,2023-12-31,2023-11,ESTIMATED,2023-11-30,,INTERVENTIONAL,CCCA,,Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA),A Pilot Study of Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,The IRB was closed without enrolling any participants,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,OTHER,,,,,,,2023,0.0
NCT03486223,,2018-03-27,2023-01-25,,2023-03-21,2018-03-27,2018-04-03,ACTUAL,2023-03-21,2023-03-23,ACTUAL,,,,2023-03-21,2023-03-23,ACTUAL,2018-05-17,ACTUAL,2018-05-17,2023-03,2023-03-31,2021-11-18,ACTUAL,2021-11-18,2021-11-18,ACTUAL,2021-11-18,,INTERVENTIONAL,,1 participant included here (in GSK-then-placebo arm) was randomized but did not receive intervention or complete a study day,Soluble Epoxide Hydrolase Inhibition and Insulin Resistance,Effect of Inhibition Soluble Epoxide Hydrolase on Insulin Sensitivity in Humans,COMPLETED,,PHASE2,16.0,ACTUAL,Vanderbilt University Medical Center,"Enrollment was not sufficient for subgroup analysis for race and gender, due to drug expiration.",2.0,,,f,,,,t,t,f,,,,,,,,,NO,Available upon request.,2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,OTHER,,,,,,,2021,1.0
NCT03241017,,2017-07-26,,,2018-04-05,2017-08-02,2017-08-07,ACTUAL,,,,,,,2018-04-05,2018-04-09,ACTUAL,2017-10,ESTIMATED,2017-10-31,2018-04,2018-04-30,2021-12,ESTIMATED,2021-12-31,2021-10,ESTIMATED,2021-10-31,,INTERVENTIONAL,IDA-D,,Durvalumab in DLBCL After Autologous Transplant,A Phase II Trial Investigating the Benefit of Immunotherapy With Durvalumab After Autologous Transplant in High-risk Diffuse-large B-cell Lymphomas (the IDA-D Trial),WITHDRAWN,,PHASE2,0.0,ACTUAL,"Insel Gruppe AG, University Hospital Bern",,1.0,,Celgene withdrew the support for this study (Durvalumab cannot be provided),f,,,,f,f,f,,,,,,,,,,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,OTHER,,,,,,,2021,0.0
NCT02214550,,2014-08-08,2022-07-20,2021-09-01,2023-05-17,2014-08-08,2014-08-12,ESTIMATED,2023-05-17,2023-06-18,ACTUAL,2021-12-21,2021-12-28,ACTUAL,2023-05-17,2023-06-18,ACTUAL,2014-07,ACTUAL,2014-07-31,2023-05,2023-05-31,2021-01,ACTUAL,2021-01-31,2020-11,ACTUAL,2020-11-30,,INTERVENTIONAL,CRAMPP,"For PBS-continuous microgestin 1/20, one of the 15 participants who signed consent and came for a screening visit, changed her mind about taking microgestin and did not come for a baseline visit, so the final sample size for that subgroup is n=14",Chronic Pain Risk Associated With Menstrual Period Pain,Deciphering the Hormonal and Nociceptive Mechanisms Underlying Bladder Pain,COMPLETED,,PHASE4,353.0,ACTUAL,NorthShore University HealthSystem,"Small sample size due to higher than expected refusal of participants with DYSB to randomize to an OCP limits generalizability. As noted above, nonserious adverse events are reported as the frequency of ever reporting an event on a form, of any intensity.",5.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,OTHER,,,,,,,2021,1.0
NCT04442581,,2020-06-18,2022-12-12,,2023-03-13,2020-06-18,2020-06-22,ACTUAL,2023-03-13,2023-04-05,ACTUAL,,,,2023-03-13,2023-04-05,ACTUAL,2021-04-20,ACTUAL,2021-04-20,2023-03,2023-03-31,2022-03-08,ACTUAL,2022-03-08,2021-12-13,ACTUAL,2021-12-13,,INTERVENTIONAL,,,Cabozantinib and Pembrolizumab for the First-Line Treatment of Advanced Liver Cancer,A Phase 2 Trial of Cabozantinib and Pembrolizumab in the First-Line Treatment of Advanced Hepatocellular Carcinoma,TERMINATED,,PHASE2,2.0,ACTUAL,University of Washington,,1.0,,Terminated due to slow accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,OTHER,,,,,,,2022,0.0
NCT02521870,,2015-07-30,2021-04-30,,2021-07-12,2015-08-10,2015-08-13,ESTIMATED,2021-07-12,2021-08-03,ACTUAL,,,,2021-07-12,2021-08-03,ACTUAL,2015-09,,2015-09-30,2021-07,2021-07-31,2020-04,ACTUAL,2020-04-30,2020-04,ACTUAL,2020-04-30,,INTERVENTIONAL,,"The intent-to-treat (ITT) population comprises all participants who received at least one dose of SD-101. Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101, as specified by the statistical analysis plan. Participants who received 1 mg or 4 mg of SD-101 in Phase 1: Dose Escalation of the study are not included in the analysis groups.",A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma,"A Phase 1b/2, Open-label, Multicenter, Dose-escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SYNERGY-001)",TERMINATED,,PHASE1/PHASE2,241.0,ACTUAL,Dynavax Technologies Corporation,"The sponsor terminated the trial early due to strategic restructuring, including the planned conclusion of clinical oncology development programs and no further sponsoring of the development of SD-101.",9.0,,A strategic restructuring including the planned conclusion of clinical oncology development programs and no further sponsoring of the development of SD-101.,f,,,,t,,,,,,,,,,,YES,Data will be shared under guidance of the New Rule - FDAAA 801 eff. Jan 2017. 3/2017 - additional changes forthcoming.,2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,INDUSTRY,,,,,,,2020,0.0
NCT03794297,,2019-01-01,,,2021-03-16,2019-01-04,2019-01-07,ACTUAL,,,,,,,2021-03-16,2021-03-17,ACTUAL,2019-01-04,ACTUAL,2019-01-04,2021-03,2021-03-31,2021-02-18,ACTUAL,2021-02-18,2021-02-18,ACTUAL,2021-02-18,,INTERVENTIONAL,,,Dabrafenib and Trametinib in Treating Patients With Erdheim Chester Disease With BRAF V600 Mutations,A Phase II Therapeutic Trial of the Use of Dabrafenib and Trametinib in Patients With BRAF V600 Mutation Positive Lesions in Erdheim Chester Disease,WITHDRAWN,,PHASE2,0.0,ACTUAL,National Cancer Institute (NCI),,1.0,,Inadequate accrual rate,f,,,,t,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page",2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,NIH,,,,,,,2021,0.0
NCT05063604,,2021-07-27,,,2022-06-29,2021-09-21,2021-10-01,ACTUAL,,,,,,,2022-06-29,2022-07-05,ACTUAL,2022-05-10,ACTUAL,2022-05-10,2022-06,2022-06-30,2022-06-29,ACTUAL,2022-06-29,2022-05-10,ACTUAL,2022-05-10,,INTERVENTIONAL,CAMAD,,Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression,"Randomized, Controlled, Open and Unicentric Phase II Clinical Trial, With Two Parallel Groups, to Evaluate the Antidepressant Efficacy of Psychotherapy and Citalopram in Women Diagnosed With Breast Cancer and Major Depression",TERMINATED,,PHASE2,40.0,ACTUAL,Hospital Universitari de Bellvitge,,2.0,,The CAMAD clinical trial has been terminated due to difficulties in recruiting patients.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,OTHER,,,,,,,2022,0.0
NCT03387332,,2017-12-13,,,2021-08-24,2017-12-28,2018-01-02,ACTUAL,,,,,,,2021-08-24,2021-08-27,ACTUAL,2017-12-01,ACTUAL,2017-12-01,2021-08,2021-08-31,2021-04-15,ACTUAL,2021-04-15,2020-11-09,ACTUAL,2020-11-09,,INTERVENTIONAL,,,APG-1252 in Patients With SCLC or Advanced Solid Tumors,"A Phase I Study of the Safety, Pharmacokinetic and Pharmacodynamic Properties of Intravenously Administered APG-1252 in Patients With Small Cell Lung Cancer (SCLC) or Advanced Solid Tumors.",TERMINATED,,PHASE1,24.0,ACTUAL,Ascentage Pharma Group Inc.,,1.0,,The company adjusts strategy.,f,,,,f,f,f,,,,,,,,,,,2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,INDUSTRY,,,,,,,2021,0.0
NCT05658029,,2022-11-30,,,2024-05-10,2022-12-12,2022-12-20,ACTUAL,,,,,,,2024-05-10,2024-05-14,ACTUAL,2023-05-23,ACTUAL,2023-05-23,2024-05,2024-05-31,2023-09-09,ACTUAL,2023-09-09,2023-09-09,ACTUAL,2023-09-09,,INTERVENTIONAL,,,An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in People With a Tracheostomy,An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in Patients With a Tracheostomy,WITHDRAWN,,PHASE1,0.0,ACTUAL,WakeMed Health and Hospitals,,1.0,,Terminated due to enrollment challenges,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,OTHER,,,,,,,2023,0.0
NCT03901378,,2019-04-01,,,2021-01-21,2019-04-02,2019-04-03,ACTUAL,,,,,,,2021-01-21,2021-01-25,ACTUAL,2019-10-02,ACTUAL,2019-10-02,2021-01,2021-01-31,2021-01-21,ACTUAL,2021-01-21,2021-01-21,ACTUAL,2021-01-21,,INTERVENTIONAL,,,Pembrolizumab With Chemotherapy in Metastatic or Unresectable High Grade Gastroenteropancreatic or Lung Neuroendocrine Carcinoma,A Phase II Trial of Pembrolizumab in Combination With Cisplatin or Carboplatin and Etoposide in Chemotherapy naïve Patients With Metastatic or Unresectable High Grade Gastroenteropancreatic or Lung (Excluding Small Cell) Neuroendocrine Carcinoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,Ochsner Health System,,1.0,,Lack of accrual,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,OTHER,,,,,,,2021,0.0
NCT01243476,,2010-11-17,,,2023-02-14,2010-11-17,2010-11-18,ESTIMATED,,,,,,,2023-02-14,2023-02-15,ACTUAL,2010-01,,2010-01-31,2023-01,2023-01-31,2022-06-06,ACTUAL,2022-06-06,2022-06-06,ACTUAL,2022-06-06,,INTERVENTIONAL,SINTRA-REV,,Study of REVLIMID (Lenalidomide) Versus Placebo in Patients With Low Risk Myelodysplastic Syndrome,"Multicenter, Randomized, Double-blind, Phase III Study of REVLIMID (Lenalidomide) Versus Placebo in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) With Alteration in 5q- and Anemia Without the Need of Transfusion.",COMPLETED,,PHASE3,61.0,ACTUAL,Fundación General de la Universidad de Salamanca,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,OTHER,,,,,,,2022,1.0
NCT03008512,,2016-12-29,,,2021-02-02,2016-12-29,2017-01-02,ESTIMATED,,,,,,,2021-02-02,2021-02-04,ACTUAL,2016-10,ACTUAL,2016-10-31,2021-02,2021-02-28,2021-02,ACTUAL,2021-02-28,2021-02,ACTUAL,2021-02-28,,INTERVENTIONAL,,,A Phase II Study of Weekly Genexol-PM in Patients With Hepatocelluar Carcinoma After Failure of Sorafenib,A Phase II Study of Weekly Genexol-PM in Patients With Advanced Hepatocelluar Carcinoma After Failure of Sorafenib,TERMINATED,,PHASE2,5.0,ACTUAL,Gachon University Gil Medical Center,,1.0,,Poor accrual,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,OTHER,,,,,,,2021,0.0
NCT03338816,,2017-11-07,2020-01-30,,2024-04-17,2017-11-07,2017-11-09,ACTUAL,2020-01-30,2020-02-11,ACTUAL,,,,2024-04-17,2024-04-22,ACTUAL,2017-11-16,ACTUAL,2017-11-16,2022-05,2022-05-31,2021-05-31,ACTUAL,2021-05-31,2019-01-31,ACTUAL,2019-01-31,,INTERVENTIONAL,,Safety Analysis Set (SAS) consisted of all participants who received at least one dose of study drug.,ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP),"ENVISION: A Phase 3 Randomized, Double-blind, Placebo-Controlled Multicenter Study With an Open-label Extension to Evaluate the Efficacy and Safety of Givosiran in Patients With Acute Hepatic Porphyrias",COMPLETED,,PHASE3,94.0,ACTUAL,Alnylam Pharmaceuticals,,2.0,,,t,,,,t,t,f,,,,,,,,,YES,Access to Anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU.~Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Requests for access to data can be submitted via the website www.vivli.org.,2024-10-15 18:27:31.326059,2024-10-15 18:27:31.326059,INDUSTRY,,NCT04056481,APPROVED_FOR_MARKETING,,,,2021,1.0
NCT03906838,,2019-04-05,,,2019-07-16,2019-04-05,2019-04-08,ACTUAL,,,,,,,2019-07-16,2019-07-18,ACTUAL,2020-01-01,ESTIMATED,2020-01-01,2019-07,2019-07-31,2020-11-30,ESTIMATED,2020-11-30,2020-11-30,ESTIMATED,2020-11-30,,INTERVENTIONAL,,,Regional Anesthesia Block in Fibula Free Flap Reconstruction,Does Regional Anesthesia Reduce Postoperative Opioid Consumption in Subjects Undergoing Fibula Free Flap Reconstruction of the Head and Neck: A Prospective Trial,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Florida,,2.0,,funding not obtained,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,OTHER,,,,,,,2020,0.0
NCT04649710,,2020-11-25,,,2022-04-25,2020-11-25,2020-12-02,ACTUAL,,,,,,,2022-04-25,2022-04-28,ACTUAL,2021-06-21,ESTIMATED,2021-06-21,2022-04,2022-04-30,2021-09-22,ESTIMATED,2021-09-22,2021-09-21,ESTIMATED,2021-09-21,,INTERVENTIONAL,,,A Study to Evaluate the Drug Levels and Safety of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants,"A Double-Blind, Multicenter, Placebo-Controlled, Randomized, Parallel, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants",WITHDRAWN,,PHASE1,0.0,ACTUAL,Bristol-Myers Squibb,,4.0,,Business objectives have changed,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,INDUSTRY,,,,,,,2021,0.0
NCT05065619,,2021-10-01,2023-03-09,,2023-10-13,2021-10-01,2021-10-04,ACTUAL,2023-04-27,2023-05-01,ACTUAL,,,,2023-10-13,2023-11-07,ACTUAL,2021-10-02,ACTUAL,2021-10-02,2023-10,2023-10-31,2023-01-29,ACTUAL,2023-01-29,2022-03-12,ACTUAL,2022-03-12,,INTERVENTIONAL,,"Safety population included all randomized subjects who received at least 1 dose of the investigational product.~After randomization, one subject withdrew before receiving investigational product at the subject's request.",Safety Immunogenicity Study of MT-2766 in Japanese Adults（COVID-19）,"A Phase I/II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of MT-2766 in Japanese Adults (COVID-19)",TERMINATED,,PHASE1/PHASE2,128.0,ACTUAL,Medicago,,3.0,,Public vaccination of approved ancestral strain COVID-19 vaccines will be terminated soon. And boosters must be dosed after ancestral vaccination approved in Japan. The study was terminated for ethical reason to prioritize the ancestral vaccination.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,,,,,,2023,0.0
NCT04965714,,2021-07-01,,,2023-02-14,2021-07-07,2021-07-16,ACTUAL,,,,,,,2023-02-14,2023-02-16,ACTUAL,2022-04-13,ACTUAL,2022-04-13,2023-02,2023-02-28,2023-02-10,ACTUAL,2023-02-10,2023-02-10,ACTUAL,2023-02-10,,INTERVENTIONAL,,,Nivolumab and ADI-PEG 20 Before Surgery for the Treatment of Resectable Liver Cancer,A Pre-Operative Study Evaluating Nivolumab Plus ADI-PEG 20 in Patients With Resectable Hepatocellular Carcinoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,0 patient accrual,,,,,t,t,f,,,,,,,,,,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,OTHER,,,,,,,2023,0.0
NCT05652660,,2022-12-07,2024-02-09,,2024-02-09,2022-12-07,2022-12-15,ACTUAL,2024-02-09,2024-07-26,ACTUAL,,,,2024-02-09,2024-07-26,ACTUAL,2022-12-09,ACTUAL,2022-12-09,2024-02,2024-02-29,2023-03-06,ACTUAL,2023-03-06,2023-02-09,ACTUAL,2023-02-09,,INTERVENTIONAL,,The baseline analysis population defined as all participants enrolled and who took at least 1 dose of study intervention.,A Study to Understand the Effect of a Study Medicine Called ARV-471 on Rosuvastatin in Healthy Adults,"AN INTERVENTIONAL, PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY TO EVALUATE THE EFFECT OF A SINGLE ORAL DOSE OF ARV-471 (PF-07850327) ON THE PHARMACOKINETICS OF ROSUVASTATIN IN HEALTHY PARTICIPANTS",COMPLETED,,PHASE1,12.0,ACTUAL,Pfizer,,1.0,,,f,,,,,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,INDUSTRY,,,,,,,2023,1.0
NCT01119417,,2010-05-04,,,2021-09-27,2010-05-05,2010-05-07,ESTIMATED,,,,,,,2021-09-27,2021-10-05,ACTUAL,2010-05,ACTUAL,2010-05-31,2021-09,2021-09-30,2021-05,ACTUAL,2021-05-31,2021-05,ACTUAL,2021-05-31,,INTERVENTIONAL,,,The Role of Endothelin in the Supine Hypertension of Autonomic Failure,The Role of Endothelin in the Supine Hypertension of Autonomic Failure,WITHDRAWN,,PHASE1,0.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,No participants were enrolled,f,,,,f,,,,,,,,,,,NO,,2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,OTHER,,,,,,,2021,0.0
NCT02957305,,2016-11-04,2020-07-09,,2021-04-29,2016-11-04,2016-11-06,ESTIMATED,2020-08-17,2020-09-03,ACTUAL,,,,2021-04-29,2021-04-30,ACTUAL,2016-12-21,ACTUAL,2016-12-21,2021-04,2021-04-30,2020-06-30,ACTUAL,2020-06-30,2019-10-19,ACTUAL,2019-10-19,,INTERVENTIONAL,MISO200,,Misoprostol 400 µg Versus 200 µg for Cervical Ripening in 1st Trimester Miscarriage,Comparison Between 400 µg or 200 µg of Misoprostol for Cervical Dilatation in 1st Trimester Miscarriage - A Clinical Trial,COMPLETED,,PHASE4,211.0,ACTUAL,Hospital de Clinicas de Porto Alegre,Technical problems with measurement leading to unreliable. Pregnancies with less than 8 weeks had their procedures completely done with small diameter Karman cannulas,2.0,,,f,,,,f,,,,,,,,unlimited,free to read,https://docs.google.com/spreadsheets/d/1WmVYj6LDAHrOqiCaAlq4TmHg8lhFxoucxqewNfOVVkE/edit?usp=sharing,YES,We intend to share raw data with other researchers,2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,OTHER,,,,,,,2020,1.0
NCT05758298,,2023-02-24,,,2023-09-05,2023-02-24,2023-03-07,ACTUAL,,,,,,,2023-09-05,2023-09-07,ACTUAL,2023-10-01,ESTIMATED,2023-10-01,2023-09,2023-09-30,2024-12-01,ESTIMATED,2024-12-01,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Assessing the Use of Nicotine Gum to Decrease Betel Nut Chewing in Saipan,Assessing the Use of Nicotine Gum to Decrease Betel Nut Chewing in Saipan,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Texas Southwestern Medical Center,,3.0,,Have not received IRB approval.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,OTHER,,,,,,,2024,0.0
NCT04632199,,2020-10-23,,,2022-08-22,2020-11-11,2020-11-17,ACTUAL,,,,,,,2022-08-22,2022-08-24,ACTUAL,2021-03-12,ESTIMATED,2021-03-12,2022-08,2022-08-31,2021-12-10,ESTIMATED,2021-12-10,2021-12-10,ESTIMATED,2021-12-10,,INTERVENTIONAL,,,Study to Assess the Safety and Efficacy of Intravenous Injection of the Imaging Agent 111In-IPN01087 in Patients With Locally Advanced or Metastatic Pancreatic or Colorectal Cancer.,"A Phase I, Open Label, Study to Assess Safety, Tolerability, Biodistribution, Radiation Dosimetry and SPECT/CT Imaging Characteristics of Intravenous 111In-IPN01087 in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma or Colorectal Cancer.",WITHDRAWN,,PHASE1,0.0,ACTUAL,Ipsen,,2.0,,Business decision not related to any safety or tolerability concern,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,INDUSTRY,,,,,,,2021,0.0
NCT02601378,,2015-11-06,,,2022-09-27,2015-11-06,2015-11-10,ESTIMATED,,,,,,,2022-09-27,2022-09-29,ACTUAL,2016-02-01,ACTUAL,2016-02-01,2022-09,2022-09-30,2022-01-07,ACTUAL,2022-01-07,2022-01-07,ACTUAL,2022-01-07,,INTERVENTIONAL,,,A Phase I Study of LXS196 in Patients With Metastatic Uveal Melanoma.,"A Phase I, Multi-center, Open-label, Study of LXS196, an Oral Protein Kinase C Inhibitor, in Patients With Metastatic Uveal Melanoma",TERMINATED,,PHASE1,107.0,ACTUAL,Novartis,,2.0,,The combination part of the study was terminated early due to business reasons,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,INDUSTRY,,,,,,,2022,0.0
NCT04125745,,2018-08-28,2021-11-08,,2021-12-14,2019-10-10,2019-10-14,ACTUAL,2021-12-14,2022-01-12,ACTUAL,,,,2021-12-14,2022-01-12,ACTUAL,2019-10-31,ACTUAL,2019-10-31,2021-12,2021-12-31,2020-12-01,ACTUAL,2020-12-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,PAH,,Oral CXA-10 in Pulmonary Arterial Hypertension,Phase 2 Open-Label Study of Safety and Efficacy Trial of CXA-10 in Pulmonary Arterial Hypertension,TERMINATED,,PHASE2,1.0,ACTUAL,University of Pittsburgh,The clinical trial was terminated early due to lack of efficacy based on the negative study outcome from the drug company's multicenter clinical trial. Early termination leading to small numbers of subjects analyzed.,1.0,,negative study outcome from Complexa's multicenter clinical trial; no safety concerns,f,,,,t,t,f,,,,,,Starting 6 months after publication,Through a data sharing agreement,,YES,"The PI will make individual participant data (IPD) available through a data sharing agreement. After publication, data will be deposited in all available suitable public access databases for archival purposes.",2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,OTHER,,,,,,,2020,0.0
NCT02165215,,2014-06-13,2021-03-30,,2021-07-27,2014-06-16,2014-06-17,ESTIMATED,2021-05-20,2021-06-15,ACTUAL,,,,2021-07-27,2021-08-19,ACTUAL,2014-08-12,ACTUAL,2014-08-12,2021-07,2021-07-31,2020-04-06,ACTUAL,2020-04-06,2020-04-06,ACTUAL,2020-04-06,,INTERVENTIONAL,LAUREL,,A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors,"Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared With Placebo in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors",COMPLETED,,PHASE3,359.0,ACTUAL,Hoffmann-La Roche,,3.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,INDUSTRY,,,,,,,2020,1.0
NCT03473340,,2018-03-14,2022-07-23,,2022-07-23,2018-03-14,2018-03-22,ACTUAL,2022-07-23,2022-08-17,ACTUAL,,,,2022-07-23,2022-08-17,ACTUAL,2018-04-27,ACTUAL,2018-04-27,2022-07,2022-07-31,2021-08-20,ACTUAL,2021-08-20,2021-07-23,ACTUAL,2021-07-23,,INTERVENTIONAL,,,Studying the Treatment Effect of Pirfenidone in Chronic Lung Allograft Dysfunction (STOP-CLAD),"A Phase Two Randomized, Double-blinded, Placebo-controlled Study Combining Physiological, Radiographic, and Biological Biomarkers to Study the Anti-fibrotic Effect of Pirfenidone in CLAD Post Lung-transplantation",TERMINATED,,PHASE2,24.0,ACTUAL,University of Michigan,,2.0,,"Slow and delayed recruitment due in part to COVID, led to a decision to end funding and terminate the trial.",f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,OTHER,,,,,,,2021,0.0
NCT03277248,,2017-09-07,2021-11-11,2021-05-11,2021-11-11,2017-09-07,2017-09-11,ACTUAL,2021-11-11,2021-12-06,ACTUAL,2021-05-11,2021-05-20,ACTUAL,2021-11-11,2021-12-06,ACTUAL,2017-08-25,ACTUAL,2017-08-25,2021-11,2021-11-30,2020-11-12,ACTUAL,2020-11-12,2020-08-04,ACTUAL,2020-08-04,,INTERVENTIONAL,ULTIMATE II,Intention-to-treat (ITT) population consisted of all randomized participants.,Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS),Phase III: UbLiTuximab in Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY),COMPLETED,,PHASE3,545.0,ACTUAL,"TG Therapeutics, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,Data will be shared after study completion via publication.,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,,,,,,2020,1.0
NCT00703820,,2008-06-20,2018-03-02,,2021-08-06,2008-06-23,2008-06-24,ESTIMATED,2018-03-29,2018-04-02,ACTUAL,,,,2021-08-06,2021-08-10,ACTUAL,2008-08-04,ACTUAL,2008-08-04,2021-07,2021-07-31,2020-08-14,ACTUAL,2020-08-14,2017-03-30,ACTUAL,2017-03-30,,INTERVENTIONAL,,,Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia,AML08: A Phase II Randomized Trial of Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Phase II Study Of Natural Killer Cell Transplantation In Patients With Newly Diagnosed Acute Myeloid Leukemia,COMPLETED,,PHASE3,324.0,ACTUAL,St. Jude Children's Research Hospital,,2.0,,,f,,,,t,t,t,t,,,,,,,,,,2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,OTHER,,,,,,,2020,1.0
NCT03859752,,2019-02-26,,,2023-09-20,2019-02-27,2019-03-01,ACTUAL,,,,,,,2023-09-20,2023-09-22,ACTUAL,2019-08-14,ACTUAL,2019-08-14,2023-07,2023-07-31,2023-12-31,ESTIMATED,2023-12-31,2023-07-04,ACTUAL,2023-07-04,,INTERVENTIONAL,,,TR1801-ADC in Patients With Tumors That Express c-Met,"A Phase 1, Open Label, First-in-human Study of TR1801-ADC, an Antibody Drug Conjugate (ADC), in Patients With Select Solid Tumors Expressing c-Met",SUSPENDED,,PHASE1,15.0,ACTUAL,"Open Innovation Partners, Inc.",,1.0,,Financial funds were withdrawn by investors and study was stopped,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,INDUSTRY,,,,,,,2023,0.0
NCT04349930,,2020-04-13,,,2021-01-12,2020-04-13,2020-04-16,ACTUAL,,,,,,,2021-01-12,2021-01-15,ACTUAL,2021-01,ESTIMATED,2021-01-31,2021-01,2021-01-31,2022-09,ESTIMATED,2022-09-30,2022-07,ESTIMATED,2022-07-31,,INTERVENTIONAL,CHRONIC,,The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC),The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC),WITHDRAWN,,PHASE1,0.0,ACTUAL,University of New Mexico,,2.0,,Need to obtain IND approval.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,OTHER,,,,,,,2022,0.0
NCT04902885,,2021-05-08,2024-04-19,,2024-07-07,2021-05-21,2021-05-26,ACTUAL,2024-07-07,2024-07-10,ACTUAL,,,,2024-07-07,2024-07-10,ACTUAL,2021-05-25,ACTUAL,2021-05-25,2024-04,2024-04-30,2022-12-31,ACTUAL,2022-12-31,2021-12-29,ACTUAL,2021-12-29,,INTERVENTIONAL,,,"Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Small Cell Lung Cancer Patients","A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Extensive-Stage Small Cell Lung Cancer Patients",COMPLETED,,PHASE3,95.0,ACTUAL,"Jiangsu Simcere Pharmaceutical Co., Ltd.",,3.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,INDUSTRY,,,,,,,2022,1.0
NCT03894540,,2019-03-27,2021-10-22,,2022-08-22,2019-03-27,2019-03-28,ACTUAL,2021-10-22,2021-11-22,ACTUAL,,,,2022-08-22,2022-09-13,ACTUAL,2019-03-22,ACTUAL,2019-03-22,2022-08,2022-08-31,2020-12-21,ACTUAL,2020-12-21,2020-12-21,ACTUAL,2020-12-21,,INTERVENTIONAL,,Safety population included all participants who were exposed to (or started receiving) IPN60090.,Dose Escalation and Dose Expansion Study of IPN60090 in Patients With Advanced Solid Tumours,"A Phase I, Open Label, Dose Escalation and Dose Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumour Activity of IPN60090 as Single Agent and in Combination in Patients With Advanced Solid Tumours",TERMINATED,,PHASE1,22.0,ACTUAL,Ipsen,The study was terminated by the sponsor following an internal portfolio review during the dose escalation phase (Part A). The early termination was not due to any safety or tolerability issues with IPN60090.,4.0,,"Following an internal portfolio review, Ipsen has made the decision to terminate study D-US-60090-001. Ipsen would like to highlight that early termination was not due to any safety or tolerability issues with IPN60090",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,INDUSTRY,,,,,,,2020,0.0
NCT02227238,,2014-08-25,2018-07-25,,2023-02-09,2014-08-25,2014-08-28,ESTIMATED,2019-04-24,2019-07-12,ACTUAL,,,,2023-02-09,2023-03-13,ACTUAL,2014-12-11,ACTUAL,2014-12-11,2023-01,2023-01-31,2022-02-14,ACTUAL,2022-02-14,2017-08-02,ACTUAL,2017-08-02,,INTERVENTIONAL,,Baseline Characteristic data are reported for members of the ITT-E Population which comprised of all participants who received at least one dose of study medication.,Comparative Efficacy and Safety Study of Dolutegravir and Lopinavir/Ritonavir in Second-line Treatment,"A Phase 3b, Randomized, Open-label Study of the Antiviral Activity and Safety of Dolutegravir Compared to Lopinavir/Ritonavir Both Administered With Dual Nucleoside Reverse Transcriptase Inhibitor Therapy in HIV-1 Infected Adult Subjects With Treatment Failure on First Line Therapy",COMPLETED,,PHASE3,627.0,ACTUAL,ViiV Healthcare,,2.0,,,f,,,,t,f,f,,,,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/,YES,Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,,,,,,2022,1.0
NCT02911961,,2016-08-17,,,2021-08-27,2016-09-20,2016-09-23,ESTIMATED,,,,,,,2021-08-27,2021-09-02,ACTUAL,2021-08,ESTIMATED,2021-08-31,2021-08,2021-08-31,2021-08,ESTIMATED,2021-08-31,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,,,APAP-CYS Protein Adduct Concentrations in Patients With Liver-Directed Therapy Intended to Treat Hepatic Tumors,Serum Acetaminophen-Cysteine (APAP-CYS) Adduct Concentrations in Subjects Expected to Develop Aminotransferase Elevations With Liver-Directed Therapy Intended to Treat Hepatic Tumors,WITHDRAWN,,PHASE4,0.0,ACTUAL,Denver Health and Hospital Authority,,2.0,,Due to lack of enrollment and organizational desire to focus recruitment efforts on other studies.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,OTHER,,,,,,,2021,0.0
NCT05673889,,2022-12-21,2024-03-15,,2024-03-15,2022-12-21,2023-01-06,ACTUAL,2024-03-15,2024-08-16,ACTUAL,,,,2024-03-15,2024-08-16,ACTUAL,2023-01-27,ACTUAL,2023-01-27,2024-03,2024-03-31,2023-04-19,ACTUAL,2023-04-19,2023-03-15,ACTUAL,2023-03-15,,INTERVENTIONAL,,The baseline analysis population was defined as all participants enrolled and who took at least 1 dose of study intervention.,A Study to Understand the Effect of a Study Medicine Called ARV-471 on Dabigatran Etexilate in Healthy Adults,"AN INTERVENTIONAL, PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY TO EVALUATE THE EFFECT OF A SINGLE ORAL DOSE OF ARV-471 (PF-07850327) ON THE PHARMACOKINETICS OF DABIGATRAN IN HEALTHY PARTICIPANTS",COMPLETED,,PHASE1,24.0,ACTUAL,Pfizer,,1.0,,,f,,,,,f,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,INDUSTRY,,,,,,,2023,1.0
NCT02729961,,2016-03-29,,,2019-10-08,2016-03-31,2016-04-06,ESTIMATED,,,,,,,2019-10-08,2019-10-10,ACTUAL,2018-01-03,ACTUAL,2018-01-03,2019-10,2019-10-31,2023-07-01,ESTIMATED,2023-07-01,2023-07-01,ESTIMATED,2023-07-01,,INTERVENTIONAL,,,Ceritinib With Brentuximab Vedotin in Treating Patients With ALK-Positive Anaplastic Large Cell Lymphoma,A Phase I/II Open-Label Dose-Finding Study of Ceritinib Combined With Brentuximab Vedotin for Front-Line Treatment of ALK-Positive Anaplastic Large Cell Lymphoma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Washington,,1.0,,Administrative closure,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,OTHER,,,,,,,2023,0.0
NCT01464034,,2011-10-19,,,2022-07-28,2011-11-02,2011-11-03,ESTIMATED,,,,,,,2022-07-28,2022-08-01,ACTUAL,2011-11,,2011-11-30,2022-07,2022-07-31,2020-07,ACTUAL,2020-07-31,2020-07,ACTUAL,2020-07-31,,INTERVENTIONAL,,,A Safety and Efficacy Study of Carfilzomib and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma,"A Multi-Center Phase I/II, Open-Label, Dose-Finding Pilot Study of the Combination of Carfilzomib and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma",TERMINATED,,PHASE1/PHASE2,136.0,ACTUAL,"Criterium, Inc.",,1.0,,Lack of enrollment,f,,,,f,,,,,,,,,,,,,2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,INDUSTRY,,,,,,,2020,0.0
NCT03736447,,2018-11-07,2023-02-02,,2023-02-02,2018-11-07,2018-11-09,ACTUAL,2023-02-02,2023-03-02,ACTUAL,,,,2023-02-02,2023-03-02,ACTUAL,2018-12-27,ACTUAL,2018-12-27,2023-02,2023-02-28,2022-07-05,ACTUAL,2022-07-05,2022-07-05,ACTUAL,2022-07-05,,INTERVENTIONAL,POSEIDON,,Peanut Oral Immunotherapy Study of Early Intervention for Desensitization,Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON),COMPLETED,,PHASE3,146.0,ACTUAL,"Aimmune Therapeutics, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,INDUSTRY,,,,,,,2022,1.0
NCT04263519,,2020-01-23,,,2021-09-21,2020-02-07,2020-02-10,ACTUAL,,,,,,,2021-09-21,2021-09-27,ACTUAL,2021-12-01,ESTIMATED,2021-12-01,2021-09,2021-09-30,2023-01-01,ESTIMATED,2023-01-01,2022-12-01,ESTIMATED,2022-12-01,,INTERVENTIONAL,,,A Pilot Open Labeled Study of Tacrolimus in Alzheimer's Disease.,A Pilot Open Labeled Study of Tacrolimus to Assess it's Effects on Bio-markers of Mild Cognitive Impairment and Alzheimer's Disease,WITHDRAWN,,PHASE2,0.0,ACTUAL,Massachusetts General Hospital,,2.0,,Covid restrictions,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,OTHER,,,,,,,2023,0.0
NCT03338998,,2017-11-08,2021-05-11,,2022-08-11,2017-11-08,2017-11-09,ACTUAL,2021-05-11,2021-06-07,ACTUAL,,,,2022-08-11,2022-08-12,ACTUAL,2017-12-24,ACTUAL,2017-12-24,2022-08,2022-08-31,2020-05-13,ACTUAL,2020-05-13,2020-05-13,ACTUAL,2020-05-13,,INTERVENTIONAL,,,"Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH).","A Phase II, Patient- and Investigator-blinded, Randomized, Placebo-controlled Study to Evaluate Efficacy, Safety and Tolerability of BAF312 (Siponimod) in Patients With Stroke Due to Intracerebral Hemorrhage (ICH)",COMPLETED,,PHASE2,32.0,ACTUAL,Novartis,,2.0,,,f,,,,t,t,f,,,,,,,,https://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,INDUSTRY,,,,,,,2020,1.0
NCT03524898,,2018-04-24,,,2022-09-27,2018-05-14,2018-05-15,ACTUAL,,,,,,,2022-09-27,2022-09-28,ACTUAL,2018-10-02,ACTUAL,2018-10-02,2022-09,2022-09-30,2022-02-15,ACTUAL,2022-02-15,2022-02-15,ACTUAL,2022-02-15,,INTERVENTIONAL,,,NAPAGE: NAb-PAclitaxel and GEmcitabine in Advanced Soft Tissue Sarcoma,NAPAGE: NAb-PAclitaxel and GEmcitabine in Advanced Soft Tissue Sarcoma. A Multicenter Open-label Single Arm Phase Ib/IIa Trial,TERMINATED,,PHASE1/PHASE2,39.0,ACTUAL,Swiss Group for Clinical Cancer Research,,1.0,,"As Last patient last visit (LPLV) took place on 15/02/2022, the trial was ended prematurely on this date in accordance with SAKK/CI.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,OTHER,,,,,,,2022,0.0
NCT05544734,,2022-09-13,2023-08-29,,2023-09-25,2022-09-13,2022-09-16,ACTUAL,2023-09-25,2023-09-28,ACTUAL,,,,2023-09-25,2023-09-28,ACTUAL,2022-11-10,ACTUAL,2022-11-10,2023-09,2023-09-30,2023-06-01,ACTUAL,2023-06-01,2023-05-15,ACTUAL,2023-05-15,,INTERVENTIONAL,,,Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia,Analysis of Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia,COMPLETED,,PHASE4,20.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,,f,,,,,t,f,,,t,,,,,,NO,,2024-10-15 09:10:19.120384,2024-10-15 09:10:19.120384,OTHER,,,,,,,2023,1.0
NCT04702568,,2021-01-07,,,2024-05-06,2021-01-08,2021-01-11,ACTUAL,,,,,,,2024-05-06,2024-05-07,ACTUAL,2020-12-18,ACTUAL,2020-12-18,2024-05,2024-05-31,2023-10-04,ACTUAL,2023-10-04,2023-10-04,ACTUAL,2023-10-04,,INTERVENTIONAL,,,A Long Term Safety Study of BCX9930 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH),"A Phase 2, Open-Label Study to Evaluate the Long-term Safety of Oral BCX9930 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)",TERMINATED,,PHASE2,19.0,ACTUAL,BioCryst Pharmaceuticals,,1.0,,Sponsor decision,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,INDUSTRY,,,,,,,2023,0.0
NCT04359953,,2020-04-17,,,2022-07-07,2020-04-21,2020-04-24,ACTUAL,,,,,,,2022-07-07,2022-07-11,ACTUAL,2020-04-25,ACTUAL,2020-04-25,2022-07,2022-07-31,2022-06-01,ACTUAL,2022-06-01,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,COVID-Aging,,"Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on the Survival of Hospitalized Elderly Patients With COVID-19","Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on the Survival of Hospitalized Elderly Patients With COVID-19: a Randomized, Multicenter, Adaptative Study",TERMINATED,,PHASE3,16.0,ACTUAL,"University Hospital, Strasbourg, France",,4.0,,difficulty in recruiting,f,,,,t,f,f,,,,,,,,,,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,OTHER,,,,,,,2022,0.0
NCT03060629,,2017-02-17,2023-02-02,,2023-03-24,2017-02-17,2017-02-23,ACTUAL,2023-03-24,2023-04-18,ACTUAL,,,,2023-03-24,2023-04-18,ACTUAL,2017-11-03,ACTUAL,2017-11-03,2023-03,2023-03-31,2022-02-02,ACTUAL,2022-02-02,2022-02-02,ACTUAL,2022-02-02,,INTERVENTIONAL,,,A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa,"A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2b Efficacy Study of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-adjuvanted Clade C gp140 in Preventing HIV-1 Infection in Adult Women in Sub-Saharan Africa",TERMINATED,,PHASE2,2636.0,ACTUAL,Janssen Vaccines & Prevention B.V.,,2.0,,Study was terminated by the sponsor after the last participant completed the Month 24 visit as the pre-specified criteria to continue the study were not met.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 09:16:04.300853,2024-10-15 09:16:04.300853,INDUSTRY,,,,,,,2022,0.0
NCT04422431,,2020-05-22,2023-05-18,,2024-07-08,2020-06-05,2020-06-09,ACTUAL,2023-06-30,2023-07-03,ACTUAL,,,,2024-07-08,2024-07-10,ACTUAL,2020-12-02,ACTUAL,2020-12-02,2024-07,2024-07-31,2023-05-17,ACTUAL,2023-05-17,2022-05-21,ACTUAL,2022-05-21,,INTERVENTIONAL,,The Full Analysis Set in the Treatment Period included all participants who received at least 1 dose of study drug in the Treatment Period and had at least a Baseline liver copper (Cu) value evaluable.,Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840,"A Phase 2, Single-arm Pathologist-blinded 48-week Study Using Liver Biopsy Specimens to Assess Copper Concentration and Histopathologic Changes in ALXN1840-treated Patients With Wilson Disease Followed by an up to 48-weeks Extension Period",COMPLETED,,PHASE2,31.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,,,,,,2023,1.0
NCT03999216,,2019-06-24,,,2023-04-10,2019-06-24,2019-06-26,ACTUAL,,,,,,,2023-04-10,2023-04-12,ACTUAL,2023-07,ESTIMATED,2023-07-31,2023-04,2023-04-30,2024-06,ESTIMATED,2024-06-30,2024-01,ESTIMATED,2024-01-31,,INTERVENTIONAL,,,Comparing Diuretic Strategies in Hospitalized Heart Failure,Creating a Platform for Point-of-Care Pragmatic Clinical Trials: Comparing Diuretic Strategies in Heart Failure,WITHDRAWN,,PHASE4,0.0,ACTUAL,Stanford University,,2.0,,Due to administrative and logistical barriers this trial has been withdrawn.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,OTHER,,,,,,,2024,0.0
NCT03952130,,2019-05-14,2022-12-21,,2023-02-03,2019-05-14,2019-05-16,ACTUAL,2023-02-03,2023-02-08,ACTUAL,,,,2023-02-03,2023-02-08,ACTUAL,2019-05-29,ACTUAL,2019-05-29,2023-02,2023-02-28,2022-01-10,ACTUAL,2022-01-10,2022-01-10,ACTUAL,2022-01-10,,INTERVENTIONAL,,All randomized participants.,A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes,"A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 1 Diabetes",COMPLETED,,PHASE3,354.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,INDUSTRY,,,,,,,2022,1.0
NCT04444141,,2020-06-21,,,2022-10-17,2020-06-21,2020-06-23,ACTUAL,,,,,,,2022-10-17,2022-10-19,ACTUAL,2020-05-15,ACTUAL,2020-05-15,2022-10,2022-10-31,2022-09-30,ACTUAL,2022-09-30,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,,,A Study of PD-1/CTLA-4 Bispecific AK104 in Relapsed or Refractory Peripheral T-cell Lymphoma,"A Multicenter, Open-label, Phase Ib/II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Subjects With Relapsed or Refractory Peripheral T Cell Lymphoma",TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,Akeso,,1.0,,"Due to difficuty of erollment and consideration of clinical guideline,The sponsor decided to stop study.",f,,,,,f,f,,,,,,,,,,,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,,,,,,2022,0.0
NCT03912831,,2019-04-10,2023-03-07,,2023-12-22,2019-04-10,2019-04-11,ACTUAL,2023-12-22,2023-12-26,ACTUAL,,,,2023-12-22,2023-12-26,ACTUAL,2019-04-30,ACTUAL,2019-04-30,2023-12,2023-12-31,2022-02-18,ACTUAL,2022-02-18,2022-02-18,ACTUAL,2022-02-18,,INTERVENTIONAL,,Safety analysis set included all participants who were treated with any dose of KITE-439.,Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers,A Phase 1 Study Evaluating the Safety and Efficacy of HPV16 E7 T Cell Receptor Engineered T Cells (KITE-439) in HLA-A*02:01+ Subjects With Relapsed/Refractory HPV16+ Cancers,TERMINATED,,PHASE1,8.0,ACTUAL,Gilead Sciences,,7.0,,Development program terminated,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,INDUSTRY,,,,,,,2022,0.0
NCT04771351,,2021-02-23,,,2022-08-15,2021-02-23,2021-02-25,ACTUAL,,,,,,,2022-08-15,2022-08-16,ACTUAL,2021-04,ESTIMATED,2021-04-30,2022-08,2022-08-31,2021-10,ESTIMATED,2021-10-31,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,,,Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adults With COVID-19,"A Randomized, Blinded-controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adult Patients With COVID-19",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,3.0,,A different study will be conducted.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,INDUSTRY,,,,,,,2021,0.0
NCT02710396,,2016-03-11,2023-06-28,,2023-07-21,2016-03-15,2016-03-16,ESTIMATED,2023-07-21,2023-07-24,ACTUAL,,,,2023-07-21,2023-07-24,ACTUAL,2016-05-31,ACTUAL,2016-05-31,2023-07,2023-07-31,2021-03-10,ACTUAL,2021-03-10,2021-03-10,ACTUAL,2021-03-10,,INTERVENTIONAL,,No subjects enrolled to cohort 3,Genetic Predictors of Benefit to Pembrolizumab,Identifying Genetic Predictors of Durable Clinical Benefit to Pembrolizumab in Advanced Non-small Cell Lung Cancer (NSCLC) Alone and in Combination With Chemotherapy.,TERMINATED,,PHASE2,19.0,ACTUAL,Columbia University,,3.0,,Frontline pembrolizumab approved in NSCLC as monotherapy and in combination with chemotherapy representing a new standard of care.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:16:04.300853,2024-10-15 09:16:04.300853,OTHER,,,,,,,2021,0.0
NCT03893617,,2019-03-26,,,2023-07-17,2019-03-26,2019-03-28,ACTUAL,,,,,,,2023-07-17,2023-07-18,ACTUAL,2017-10-05,ACTUAL,2017-10-05,2023-07,2023-07-31,2022-01-27,ACTUAL,2022-01-27,2022-01-27,ACTUAL,2022-01-27,,INTERVENTIONAL,,,Brief Stresses Experimental Study,Brief Stresses and DNA Integrity: An Experimental Analysis,TERMINATED,,PHASE1,239.0,ACTUAL,University of Pittsburgh,,2.0,,"Due to challenges associated with the Covid-19 pandemic, we were unable to complete recruitment as planned during the period we had funding to do so.",f,,,,,t,f,,,f,,,,,,,,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,OTHER,,,,,,,2022,0.0
NCT03572062,,2018-06-01,2021-06-21,,2021-08-25,2018-06-18,2018-06-28,ACTUAL,2021-08-25,2021-08-26,ACTUAL,,,,2021-08-25,2021-08-26,ACTUAL,2018-06-05,ACTUAL,2018-06-05,2021-08,2021-08-31,2020-08-19,ACTUAL,2020-08-19,2020-06-23,ACTUAL,2020-06-23,,INTERVENTIONAL,,Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.,A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults,"A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND,DOSE-FINDING, FIRST-IN-HUMAN STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF AN ADJUVANTED RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN HEALTHY OLDER ADULTS",TERMINATED,,PHASE2,317.0,ACTUAL,Pfizer,"Study follow up of the Month-0, Month-2 cohort was terminated early due to sponsor decision, with all participants followed up through 6 months after Vaccination 2.",10.0,,"Study halted prematurely by sponsor and will not resume, participants are no longer being examined or receiving intervention.",f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 09:16:04.300853,2024-10-15 09:16:04.300853,INDUSTRY,,,,,,,2020,0.0
NCT05541952,,2022-07-25,,,2023-10-18,2022-09-13,2022-09-15,ACTUAL,,,,,,,2023-10-18,2023-10-19,ACTUAL,2020-08-17,ESTIMATED,2020-08-17,2023-10,2023-10-31,2020-08-17,ESTIMATED,2020-08-17,2020-08-17,ESTIMATED,2020-08-17,,INTERVENTIONAL,PPT-BCG,,BCG Re-vaccination for Primary Tuberculosis Prophylaxis in the Prison Population,BCG Re-vaccination for Primary Tuberculosis Prophylaxis in the Prison Population,WITHDRAWN,,PHASE4,0.0,ACTUAL,Federal University of Mato Grosso,,2.0,,"New evidence points to a new candidate vaccine, with a superior trial to BCG.",f,,,,f,f,f,,,,,,,,,,,2024-10-15 09:16:04.300853,2024-10-15 09:16:04.300853,OTHER,,,,,,,2020,0.0
NCT02975336,,2016-11-23,2020-11-18,,2021-03-16,2016-11-23,2016-11-29,ESTIMATED,2020-11-18,2020-12-17,ACTUAL,,,,2021-03-16,2021-04-12,ACTUAL,2017-01-04,ACTUAL,2017-01-04,2021-03,2021-03-31,2020-03-23,ACTUAL,2020-03-23,2019-11-27,ACTUAL,2019-11-27,,INTERVENTIONAL,,,A Phase II Study of M2951 in SLE,"A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With SLE",TERMINATED,,PHASE2,469.0,ACTUAL,EMD Serono,Primary and Secondary endpoints were planned to be analyze only for Double-Blind Placebo-controlled period.,8.0,,Study is completed; primary analysis completed.,f,,,,t,,,,,,,,,,,,,2024-10-15 09:16:04.300853,2024-10-15 09:16:04.300853,INDUSTRY,,,,,,,2020,0.0
NCT04357951,,2020-04-20,,,2023-04-12,2020-04-20,2020-04-22,ACTUAL,,,,,,,2023-04-12,2023-04-14,ACTUAL,2023-04-15,ESTIMATED,2023-04-15,2023-04,2023-04-30,2024-09,ESTIMATED,2024-09-30,2024-03,ESTIMATED,2024-03-31,,INTERVENTIONAL,,,D-cycloserine Augmented Treatment for Youth With Tic Disorders,D-cycloserine Augmented Treatment: Enhancing Extinction Learning in Youth With Tic Disorders,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Johns Hopkins University,,2.0,,Low enrollment,f,,,,f,t,f,,,f,,,,,,NO,This is a pilot study intended to demonstrate feasibility and test preliminary efficacy. The investigators do not plan to share individual participant data.,2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,OTHER,,,,,,,2024,0.0
NCT04353271,,2020-03-25,2021-12-17,,2021-12-29,2020-04-17,2020-04-20,ACTUAL,2021-12-29,2022-01-03,ACTUAL,,,,2021-12-29,2022-01-03,ACTUAL,2020-04-17,ACTUAL,2020-04-17,2021-12,2021-12-31,2020-07-08,ACTUAL,2020-07-08,2020-07-08,ACTUAL,2020-07-08,,INTERVENTIONAL,THICK,,Trial of Hydroxychloroquine In Covid-19 Kinetics,A Randomized Phase 2/3 Trial of Hydroxychloroquine In Covid-19 Kinetics,TERMINATED,,PHASE2/PHASE3,3.0,ACTUAL,University of South Alabama,,2.0,,FDA recommendations to not use outside of the hospital setting or in a clinical trial due to the risk of cardiac arrhythmias,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 09:16:04.300853,2024-10-15 09:16:04.300853,OTHER,,,,,,,2020,0.0
NCT04073615,,2019-08-26,,,2024-04-30,2019-08-27,2019-08-29,ACTUAL,,,,,,,2024-04-30,2024-05-02,ACTUAL,2019-11-18,ACTUAL,2019-11-18,2024-04,2024-04-30,2023-05-31,ACTUAL,2023-05-31,2023-05-31,ACTUAL,2023-05-31,,INTERVENTIONAL,,,A Study of Rivoceranib and Trifluridine/Tipiracil for Metastatic Colorectal Cancer (mCRC),"Phase 1b/2 Open-label Study to Evaluate the Safety, Tolerability and Efficacy of Rivoceranib or Trifluridine/Tipiracil as Monotherapies and Rivoceranib and Trifluridine/Tipiracil as Combination Therapy in Subjects With Metastatic Colorectal Cancer",TERMINATED,,PHASE1,29.0,ACTUAL,Elevar Therapeutics,,3.0,,Phase 2 portion of the study was not performed due to redirection of the rivoceranib development plan by the Sponsor.,f,,,,,t,f,,,,,,,,,,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,INDUSTRY,,,,,,,2023,0.0
NCT03008616,,2016-12-20,,,2022-03-31,2016-12-29,2017-01-02,ESTIMATED,,,,,,,2022-03-31,2022-04-04,ACTUAL,2017-04-12,ACTUAL,2017-04-12,2022-03,2022-03-31,2020-08-13,ACTUAL,2020-08-13,2020-08-13,ACTUAL,2020-08-13,,INTERVENTIONAL,,,Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia,"A Phase 2b/3a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of AMAG-423, a Digoxin Immune Fab, in Antepartum Subjects With Severe Preeclampsia",TERMINATED,,PHASE2/PHASE3,59.0,ACTUAL,"AMAG Pharmaceuticals, Inc.",,2.0,,"Following a recommendation from the Data and Safety Monitoring Board (DSMB), the study was stopped early for futility. There were no safety concerns raised.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,,,,,,2020,0.0
NCT04659161,,2020-12-02,2023-10-27,,2023-11-20,2020-12-02,2020-12-09,ACTUAL,2023-11-20,2023-12-12,ACTUAL,,,,2023-11-20,2023-12-12,ACTUAL,2020-12-16,ACTUAL,2020-12-16,2023-11,2023-11-30,2022-05-24,ACTUAL,2022-05-24,2022-05-24,ACTUAL,2022-05-24,,INTERVENTIONAL,,The Intent-to-Treat (ITT) population included all participants who were randomized to the study. Participants were analyzed according to randomized treatment.,A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-2),"A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adults With DSM-5 Schizophrenia",COMPLETED,,PHASE3,252.0,ACTUAL,Karuna Therapeutics,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:16:04.300853,2024-10-15 09:16:04.300853,INDUSTRY,,,,,,,2022,1.0
NCT02859415,,2016-08-06,2021-12-27,,2022-03-10,2016-08-06,2016-08-09,ESTIMATED,2022-03-10,2022-04-05,ACTUAL,,,,2022-03-10,2022-04-05,ACTUAL,2019-08-08,ACTUAL,2019-08-08,2022-03,2022-03-31,2021-12-01,ACTUAL,2021-12-01,2019-12-06,ACTUAL,2019-12-06,,INTERVENTIONAL,,,"Continuous 24h Intravenous Infusion of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in People With Primary Thoracic Malignancies or Carcinomas, Sarcomas or Germ Cell Neoplasms With Pleuropulmonary Metastases","Phase I/II Evaluation of Continuous 24h Intravenous Infusion of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in Patients With Primary Thoracic Malignancies or Carcinomas, Sarcomas or Germ Cell Neoplasms With Pleuropulmonary Metastases",TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,Slow/Insufficient accrual,f,,,,f,t,f,,,,,,,,,YES,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,NIH,,,,,,,2021,0.0
NCT02558023,,2015-08-24,,,2020-08-20,2015-09-22,2015-09-23,ESTIMATED,,,,,,,2020-08-20,2020-08-25,ACTUAL,2015-09,ACTUAL,2015-09-30,2019-08,2019-08-31,2020-08,ACTUAL,2020-08-31,2020-08,ACTUAL,2020-08-31,,INTERVENTIONAL,Uranic,,The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine,The Treatment of Hypertension Associated With Severe Preeclampsia. A Randomize Controlled Trial of Urapidil Versus Nicardipine. The Uranic Trial,TERMINATED,,PHASE3,14.0,ACTUAL,"University Hospital, Strasbourg, France",,2.0,,no candidats,f,,,,t,,,,,,,,,,,,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,OTHER,,,,,,,2020,0.0
NCT05212116,,2021-05-26,,,2022-04-14,2022-01-26,2022-01-27,ACTUAL,,,,,,,2022-04-14,2022-04-22,ACTUAL,2021-09-16,ACTUAL,2021-09-16,2022-04,2022-04-30,2022-03-11,ACTUAL,2022-03-11,2022-03-11,ACTUAL,2022-03-11,,INTERVENTIONAL,,,A Study of SDI-118 in Participants in Remission From Depression,"A Phase Ib, Exploratory, Double Blind, Placebo Controlled, Parallel Group, Study of SDI-118 to Evaluate Safety, Tolerability, and Pharmacodynamics Including Cognitive Function in Male and Female Participants in Remission From Depression",WITHDRAWN,,PHASE1,0.0,ACTUAL,Syndesi Therapeutics,,3.0,,Development Plan Amended,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,INDUSTRY,,,,,,,2022,0.0
NCT03630952,,2018-08-11,,,2021-06-22,2018-08-11,2018-08-15,ACTUAL,,,,,,,2021-06-22,2021-06-23,ACTUAL,2018-12-21,ACTUAL,2018-12-21,2021-06,2021-06-30,2021-05-19,ACTUAL,2021-05-19,2020-09-10,ACTUAL,2020-09-10,,INTERVENTIONAL,,,Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-2),"A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects With Neovascular Age-Related Macular Degeneration (AMD) (PANDA-2)",TERMINATED,,PHASE3,1157.0,ACTUAL,"Chengdu Kanghong Biotech Co., Ltd.",,3.0,,desired primary endpoint was not met,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:16:04.300853,2024-10-15 09:16:04.300853,INDUSTRY,,,,,,,2021,0.0
NCT01897454,,2013-07-09,2023-10-31,,2023-12-01,2013-07-09,2013-07-12,ESTIMATED,2023-12-01,2023-12-05,ACTUAL,,,,2023-12-01,2023-12-05,ACTUAL,2012-01-27,ACTUAL,2012-01-27,2023-12,2023-12-31,2021-11-01,ACTUAL,2021-11-01,2021-11-01,ACTUAL,2021-11-01,,INTERVENTIONAL,,,"Gemcitabine Hydrochloride, and Radiation Therapy in Patients With Borderline Resectable Pancreatic Cancer",A Phase II Trial of Preoperative FOLFIRINOX Followed by Gemcitabine Based Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Adenocarcinoma,TERMINATED,,PHASE2,23.0,ACTUAL,Albert Einstein College of Medicine,,1.0,,Study was terminated due to slower than anticipated accrual,f,,,,t,,,,,,,,,,,,,2024-10-15 09:16:04.300853,2024-10-15 09:16:04.300853,OTHER,,,,,,,2021,0.0
NCT04353310,,2019-11-13,,,2021-11-10,2020-04-16,2020-04-20,ACTUAL,,,,,,,2021-11-10,2021-11-17,ACTUAL,2021-09,ESTIMATED,2021-09-30,2021-11,2021-11-30,2021-11-09,ACTUAL,2021-11-09,2021-11-09,ACTUAL,2021-11-09,,INTERVENTIONAL,,,Evaluating Effects of Curcumin in Moderate to Severe Asthmatics,Evaluating the Effects of Curcumin in Moderate to Severe Asthmatics,WITHDRAWN,,PHASE2,0.0,ACTUAL,Loma Linda University,,2.0,,No funding,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,OTHER,,,,,,,2021,0.0
NCT02960893,,2016-11-04,2020-07-24,2018-08-01,2024-10-04,2016-11-08,2016-11-10,ESTIMATED,2020-08-13,2020-08-14,ACTUAL,2018-08-06,2018-08-08,ACTUAL,2024-10-04,2024-10-16,ESTIMATED,2016-12-15,ACTUAL,2016-12-15,2024-10,2024-10-31,2024-09-20,ACTUAL,2024-09-20,2017-08-18,ACTUAL,2017-08-18,,INTERVENTIONAL,,Safety Analysis Set (Randomization Phase): All participants who received at least one dose of study drug during the Randomization Phase.,Trial in Adult Subjects With Spinocerebellar Ataxia,"A Phase IIb/III, Randomized, Double-blind, Placebo-controlled Trial of Troriluzole in Adult Subjects With Spinocerebellar Ataxia",COMPLETED,,PHASE2/PHASE3,141.0,ACTUAL,"Biohaven Pharmaceuticals, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 04:24:16.629849,2024-10-17 04:24:16.629849,INDUSTRY,,,,,,,2024,1.0
NCT03926169,,2019-04-23,2022-07-14,2022-01-03,2022-07-14,2019-04-23,2019-04-24,ACTUAL,2022-07-14,2022-08-11,ACTUAL,2022-01-03,2022-01-05,ACTUAL,2022-07-14,2022-08-11,ACTUAL,2019-06-03,ACTUAL,2019-06-03,2022-07,2022-07-31,2021-08-02,ACTUAL,2021-08-02,2021-02-02,ACTUAL,2021-02-02,,INTERVENTIONAL,DETERMINED 1,,A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa,"A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa",COMPLETED,,PHASE2,243.0,ACTUAL,AbbVie,,6.0,,,f,,,,t,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 09:16:04.300853,2024-10-15 09:16:04.300853,INDUSTRY,,,,,,,2021,1.0
NCT04802837,,2021-03-09,2023-01-27,,2023-07-28,2021-03-15,2021-03-17,ACTUAL,2023-07-28,2023-08-21,ACTUAL,,,,2023-07-28,2023-08-21,ACTUAL,2021-05-19,ACTUAL,2021-05-19,2023-07,2023-07-31,2022-09-28,ACTUAL,2022-09-28,2021-09-17,ACTUAL,2021-09-17,,INTERVENTIONAL,Ri-CoDIFy 3,,"Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects","A Randomized, Double Blind, Active Controlled Study to Evaluate the Safety and Tolerability of Ridinilazole Compared With Vancomycin and to Assess the Pharmacokinetics of Ridinilazole in Adolescent Subjects (Aged 12 to <18 Years) With Clostridioides Difficile Infection",TERMINATED,,PHASE3,2.0,ACTUAL,Summit Therapeutics,,2.0,,SMT19969-C006 study was terminated in alignment with corporate decision to pursue further development of drug candidate with a partner.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:44:29.597253,2024-10-16 06:44:29.597253,INDUSTRY,,,,,,,2022,0.0
NCT04475991,,2020-07-15,,,2022-05-31,2020-07-15,2020-07-17,ACTUAL,,,,,,,2022-05-31,2022-06-03,ACTUAL,2021-07-13,ACTUAL,2021-07-13,2022-05,2022-05-31,2022-03-25,ACTUAL,2022-03-25,2022-03-15,ACTUAL,2022-03-15,,INTERVENTIONAL,COMVIVIR,,Safety and Efficacy of Maraviroc and/or Favipiravir With Standard Therapy in Severe COVID-19 Adults,"Phase2, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Maraviroc and/or Favipiravir Plus Standard Therapy in Adult Patients With Severe Non-critical COVID-19",TERMINATED,,PHASE2,19.0,ACTUAL,Hospital General de México Dr. Eduardo Liceaga,,4.0,,No more patients complying the selection criteria were available for recruitment,f,,,,t,f,f,,,f,,,Information will be shared upon completion of the study for collaborative purposes,Upon request,,YES,Inter-institutional exchange of data,2024-10-15 09:16:04.300853,2024-10-15 09:16:04.300853,OTHER_GOV,,,,,,,2022,0.0
NCT03922139,,2019-04-16,2022-11-18,,2023-02-08,2019-04-18,2019-04-19,ACTUAL,2023-02-08,2023-02-14,ACTUAL,,,,2023-02-08,2023-02-14,ACTUAL,2019-10-08,ACTUAL,2019-10-08,2023-02,2023-02-28,2021-12-15,ACTUAL,2021-12-15,2021-12-15,ACTUAL,2021-12-15,,INTERVENTIONAL,,,Botox for the Treatment of Chronic Exertional Compartment Syndrome,OnabotulinumtoxinA (Botox) Effect on Pain and Return to Sport in Chronic Exertional Compartment Syndrome of the Anterior Leg: A Pilot Study,TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,"University of Wisconsin, Madison",,1.0,,due to COVID-19,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 16:38:00.941523,2024-10-16 16:38:00.941523,OTHER,,,,,,,2021,0.0
NCT02007239,,2013-12-05,,,2022-03-11,2013-12-05,2013-12-10,ESTIMATED,,,,,,,2022-03-11,2022-03-28,ACTUAL,2013-12,,2013-12-31,2022-03,2022-03-31,2021-05,ACTUAL,2021-05-31,2021-05,ACTUAL,2021-05-31,,INTERVENTIONAL,,,Tocilizumab and Hemophagocytic Lymphohistiocytosis (HLH),Cytokine Blockade With Tocilizumab in Patients With Cytokine Release Syndrome and Hemophagocytic Lymphohistiocytosis,WITHDRAWN,,PHASE2,0.0,ACTUAL,Children's Hospital of Philadelphia,,1.0,,No subjects were enrolled,f,,,,t,,,,,,,,,,,,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2021,0.0
NCT04635735,,2020-11-13,2023-02-03,,2023-03-22,2020-11-13,2020-11-19,ACTUAL,2023-03-22,2023-03-23,ACTUAL,,,,2023-03-22,2023-03-23,ACTUAL,2020-01-12,ACTUAL,2020-01-12,2023-02,2023-02-28,2023-02-02,ACTUAL,2023-02-02,2023-02-02,ACTUAL,2023-02-02,,INTERVENTIONAL,,,Study of Ipilimumab After Stem Cell Transplantation in People With Relapsed/Refractory Multiple Myeloma,A Phase I/II Trial of Ipilimumab After CD34-Selected Allogeneic Stem Cell Transplantation for Patients With Relapsed/Refractory Multiple Myeloma,TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,Lack of accrual,,,,,,t,f,,,,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2023,0.0
NCT05516875,,2022-08-08,,,2024-10-10,2022-08-23,2022-08-26,ACTUAL,,,,,,,2024-10-10,2024-10-15,ACTUAL,2024-01-19,ACTUAL,2024-01-19,2024-10,2024-10-31,2024-06-27,ACTUAL,2024-06-27,2024-05-22,ACTUAL,2024-05-22,,INTERVENTIONAL,,,Open-Label Extension Study of ASTORIA,Open-Label Extension Study of JM-010 in Parkinson's Disease Patients With Dyskinesia,TERMINATED,,PHASE2,6.0,ACTUAL,Contera Pharma A/S,,2.0,,"The trial is terminated based on business decision, not due to safety concerns or regulatory requirements.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 04:24:16.629849,2024-10-17 04:24:16.629849,INDUSTRY,,,,,,,2024,0.0
NCT03559985,,2018-05-11,,,2022-10-06,2018-06-15,2018-06-18,ACTUAL,,,,,,,2022-10-06,2022-10-10,ACTUAL,2018-08-20,ACTUAL,2018-08-20,2022-10,2022-10-31,2022-08-31,ACTUAL,2022-08-31,2020-10-08,ACTUAL,2020-10-08,,INTERVENTIONAL,PAeoNy,,Paracetamol and Neuropathic Pain,Analgesic Effect of Paracetamol in Neuropathic Pain Patients,TERMINATED,,PHASE2,43.0,ACTUAL,"University Hospital, Clermont-Ferrand",,2.0,,Recruitment difficulties,f,,,,,f,f,,,,,,,,,,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2022,0.0
NCT05201703,,2022-01-07,2024-05-14,,2024-07-30,2022-01-07,2022-01-21,ACTUAL,2024-07-30,2024-07-31,ACTUAL,,,,2024-07-30,2024-07-31,ACTUAL,2022-03-09,ACTUAL,2022-03-09,2024-07,2024-07-31,2023-12-15,ACTUAL,2023-12-15,2023-12-15,ACTUAL,2023-12-15,,INTERVENTIONAL,,,Fycompa in Catamenial Epilepsy,Pilot Study of Add-On Fycompa (Perampanel)Treatment for Catamenial Epilepsy,TERMINATED,,PHASE4,7.0,ACTUAL,University of Florida,,2.0,,Poor enrollment,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 09:16:04.300853,2024-10-15 09:16:04.300853,OTHER,,,,,,,2023,0.0
NCT03653546,,2018-08-22,,,2024-10-11,2018-08-28,2018-08-31,ACTUAL,,,,,,,2024-10-11,2024-10-15,ACTUAL,2018-10-29,ACTUAL,2018-10-29,2022-11,2022-11-30,2022-07-12,ACTUAL,2022-07-12,2022-07-12,ACTUAL,2022-07-12,,INTERVENTIONAL,BM,,First Line Treatment in EGFR Mutation Positive Advanced NSCLC Patients with Central Nervous System (CNS) Metastases,"A Randomized, Open-label, Controlled, Multi-Center Phase II/III Study to Assess the Efficacy and Safety of AZD3759 Vs. a Standard of Care EGFR TKI, As First Line Treatment to EGFR Mutation Positive Advanced NSCLC with CNS Metastases",COMPLETED,,PHASE2/PHASE3,492.0,ACTUAL,"Alpha Biopharma (Jiangsu) Co., Ltd.",,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-17 04:24:16.629849,2024-10-17 04:24:16.629849,INDUSTRY,,,,,,,2022,1.0
NCT03588039,,2018-06-13,,,2023-05-18,2018-07-03,2018-07-17,ACTUAL,,,,,,,2023-05-18,2023-05-19,ACTUAL,2018-10-25,ACTUAL,2018-10-25,2023-05,2023-05-31,2023-05-12,ACTUAL,2023-05-12,2023-05-12,ACTUAL,2023-05-12,,INTERVENTIONAL,,,Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors,"Phase 1 Study With Expansion Cohorts to Assess the Safety, Tolerability, and Activity of Oraxol (Paclitaxel + HM30181A) in Combination With Pembrolizumab in Subjects With Advanced Solid Malignancies",TERMINATED,,PHASE1,34.0,ACTUAL,"Athenex, Inc.",,8.0,,Study terminated due to lack of funding,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 09:16:04.300853,2024-10-15 09:16:04.300853,INDUSTRY,,,,,,,2023,0.0
NCT04172831,,2019-11-20,2022-06-02,,2022-07-13,2019-11-20,2019-11-21,ACTUAL,2022-07-13,2022-08-08,ACTUAL,,,,2022-07-13,2022-08-08,ACTUAL,2019-12-09,ACTUAL,2019-12-09,2022-07,2022-07-31,2020-10-29,ACTUAL,2020-10-29,2020-10-29,ACTUAL,2020-10-29,,INTERVENTIONAL,RELIEF,,A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia,"A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia",COMPLETED,,PHASE3,503.0,ACTUAL,"Tonix Pharmaceuticals, Inc.",Recruitment during COVID-19 pandemic,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,INDUSTRY,,,,,,,2020,1.0
NCT03782792,,2018-12-19,2021-12-22,2021-09-16,2022-02-11,2018-12-19,2018-12-20,ACTUAL,2022-02-11,2022-03-09,ACTUAL,2022-02-11,2022-03-09,ACTUAL,2022-02-11,2022-03-09,ACTUAL,2019-01-31,ACTUAL,2019-01-31,2022-02,2022-02-28,2021-01-05,ACTUAL,2021-01-05,2020-09-23,ACTUAL,2020-09-23,,INTERVENTIONAL,,Randomized Set (RS): This patient set included all randomized patients.,Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis,"Effisayil™ 1:Multi-center, Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety and Tolerability of a Single Intravenous Dose of Spesolimab (BI 655130) in Patients With Generalized Pustular Psoriasis (GPP) Presenting With an Acute Flare of Moderate to Severe Intensity",COMPLETED,,PHASE2,53.0,ACTUAL,Boehringer Ingelheim,"Due to the trial design, a large proportion of patients had received escape medication or non-randomized spesolimab by Week 4, based on worsening, insufficient response, or non-response. This should be taken into account for the interpretation of the results at Week 4. A large proportion of patients in both arms had been treated as non-responders at Week 4, and the true efficacy outcomes for the randomized treatment at this time-point were never observed for the analysis.",2.0,,,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-15 09:16:04.300853,2024-10-15 09:16:04.300853,INDUSTRY,,,,,,,2021,1.0
NCT05590676,,2022-10-18,,,2024-03-05,2022-10-18,2022-10-21,ACTUAL,,,,,,,2024-03-05,2024-03-07,ACTUAL,2023-05-02,ACTUAL,2023-05-02,2024-03,2024-03-31,2024-02-22,ACTUAL,2024-02-22,2024-02-22,ACTUAL,2024-02-22,,INTERVENTIONAL,,,Metformin Treatment in Infants After Perinatal Brain Injury,A Phase I Safety and Feasibility of Metformin Treatment in Infants After Perinatal Brain Injury,TERMINATED,,PHASE1,1.0,ACTUAL,The Hospital for Sick Children,,4.0,,Low recruitment,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 16:43:55.4698,2024-10-16 16:43:55.4698,OTHER,,,,,,,2024,0.0
NCT04391868,,2020-05-04,,,2021-02-10,2020-05-13,2020-05-18,ACTUAL,,,,,,,2021-02-10,2021-02-15,ACTUAL,2021-01-30,ESTIMATED,2021-01-30,2021-02,2021-02-28,2021-04-28,ESTIMATED,2021-04-28,2021-04-28,ESTIMATED,2021-04-28,,INTERVENTIONAL,,,A Bioequivalence Study of Sildenafil Citrate Orally-Disintegrating Film Dosage Form,"PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 3-WAY, 6-SEQUENCE CROSSOVER STUDY TO DEMONSTRATE BIOEQUIVALENCE OF SILDENAFIL ORALLY-DISINTEGRATING FILM 50 MG WITH OR WITHOUT WATER TO ORAL TABLET OF SILDENAFIL CITRATE (VIAGRA(Registered)) 50 MG UNDER FASTED CONDITION IN HEALTHY MALE PARTICIPANTS",WITHDRAWN,,PHASE1,0.0,ACTUAL,Pfizer,,3.0,,The project has been transferred to Viatris,f,,,,,t,f,,,f,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,INDUSTRY,,,,,,,2021,0.0
NCT04568174,,2020-09-08,,,2021-10-07,2020-09-23,2020-09-29,ACTUAL,,,,,,,2021-10-07,2021-10-15,ACTUAL,2020-11-17,ACTUAL,2020-11-17,2021-10,2021-10-31,2021-09-23,ACTUAL,2021-09-23,2021-09-23,ACTUAL,2021-09-23,,INTERVENTIONAL,,,First in Human Study to Test the Safety and Preliminary Efficacy of PPSGG in Patients With Anti-MAG Neuropathy,"First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of PPSGG (PN-1007) in Anti-MAG Neuropathy Patients",TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,Polyneuron Pharmaceuticals AG,,2.0,,Data don't support further development,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,INDUSTRY,,,,,,,2021,0.0
NCT05473715,,2022-07-22,2024-07-09,,2024-09-22,2022-07-22,2022-07-26,ACTUAL,2024-09-22,2024-10-16,ESTIMATED,,,,2024-09-22,2024-10-16,ESTIMATED,2023-04-25,ACTUAL,2023-04-25,2024-09,2024-09-30,2023-07-11,ACTUAL,2023-07-11,2023-07-11,ACTUAL,2023-07-11,,INTERVENTIONAL,XPAND,,A Study to Learn How Well Aflibercept Injected Into the Eye Works and How Safe it is When Given in Customized Treatment Intervals in Patients With an Eye Disease Called Neovascular Age-related Macular Degeneration After Start of Treatment,"A Parallel-group Phase 4, Open-label, Two-arm Study to Assess the Safety and Efficacy of Intravitreal (IVT) Aflibercept With Proactive Customized Treatment Intervals in Patients ≥50 Years of Age With No Fluid Due to Choroidal Neovascularization (CNV) Lesions Secondary to Neovascular (Wet) Age-related Macular Degeneration (nAMD) Following Treatment Initiation With Aflibercept",TERMINATED,,PHASE4,3.0,ACTUAL,Bayer,The trial was terminated due to administrative reasons not related to efficacy or safety.,2.0,,Study terminated due to administrative reasons not related to efficacy or safety.,f,,,,f,t,f,,,t,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-17 04:24:16.629849,2024-10-17 04:24:16.629849,INDUSTRY,,,,,,,2023,0.0
NCT04334148,,2020-04-02,2021-10-01,,2021-10-08,2020-04-02,2020-04-06,ACTUAL,2021-10-01,2021-10-07,ACTUAL,,,,2021-10-08,2021-10-12,ACTUAL,2020-04-22,ACTUAL,2020-04-22,2021-10,2021-10-31,2021-01-09,ACTUAL,2021-01-09,2020-12-10,ACTUAL,2020-12-10,,INTERVENTIONAL,HERO-HCQ,Participants who completed the study,Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine,Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial),COMPLETED,,PHASE3,1360.0,ACTUAL,Duke University,"The study was underpowered to detect a small treatment effect. The trial was novel and improved feasibility, particularly during a pandemic. Testing was not performed at all institutions per local policies in HCW. These events were defined as suspected cases and were combined with the confirmed cases in the primary outcome. This resulted in few confirmed COVID-19 infections; thus, our primary outcome was primarily suspected COVID-19 clinical infection.",2.0,,,f,,,,t,t,f,,,f,,,July 2022,"Individual investigators or teams of investigators seeking access to data from PCORI-funded studies must complete and submit a data request form to a PCORI-designated repository. The repository will independently review requests for data based on qualifications of the data requestors and the scientific merit of the request (see below). If the data request is approved, the data requestor's institution must enter into a Data Use Agreement (DUA) with the repository. More information is available here https://www.pcori.org/about-us/governance/policy-data-management-and-data-sharing",http://www.pcori.org,YES,"Plan description: HERO-HCQ is funded by PCORI, the Patient-Centered Outcomes Research Institute. PCORI calls for the researchers PCORI funds to share their data sets and documentation for reanalysis and reuse. The policy advances PCORI's commitment to open science by encouraging use of data from the studies it funds to allow other researchers to verify and build on those findings to generate new evidence available to healthcare decision makers.",2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2021,1.0
NCT03517722,,2018-04-13,2021-11-03,,2023-12-30,2018-05-04,2018-05-07,ACTUAL,2022-02-11,2022-03-09,ACTUAL,,,,2023-12-30,2024-01-03,ACTUAL,2018-04-16,ACTUAL,2018-04-16,2023-12,2023-12-31,2020-11-05,ACTUAL,2020-11-05,2020-11-05,ACTUAL,2020-11-05,,INTERVENTIONAL,,,A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus,"A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus",TERMINATED,,PHASE3,516.0,ACTUAL,"Janssen Research & Development, LLC","Due to study termination, the open-label extension phase didn't reach the planned duration till Week 176. However, participants were assessed for safety up to Week 130 (that is, after study termination) and received study drug up to Week 113.",2.0,,Study terminated early as a result of the outcome of the pre-planned Interim Analysis,f,,,,t,t,f,,,,,,,,,,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,INDUSTRY,,,,,,,2020,0.0
NCT03580369,,2018-06-26,2022-11-30,2021-06-30,2023-07-20,2018-06-26,2018-07-09,ACTUAL,2022-12-12,2022-12-30,ACTUAL,2021-06-30,2021-07-02,ACTUAL,2023-07-20,2023-07-24,ACTUAL,2018-10-17,ACTUAL,2018-10-17,2023-07,2023-07-31,2022-06-14,ACTUAL,2022-06-14,2021-07-16,ACTUAL,2021-07-16,,INTERVENTIONAL,,"Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.~Adults (1,034) + Adolescents (38) = Total (1,072)",A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines,"A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Safety and Efficacy of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines",COMPLETED,,PHASE3,1072.0,ACTUAL,Novartis,The difference of 4 subjects between RAN (1034) vs FAS (1030) is due to mis-randomization of 4 subjects. These subjects did not receive Ligelizumab and hence rightfully not included in FAS (though included in RAN).,4.0,,,f,,,,t,t,f,,,,,,,,https://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,INDUSTRY,,,,,,,2022,1.0
NCT04388202,,2020-05-11,,,2020-10-13,2020-05-11,2020-05-14,ACTUAL,,,,,,,2020-10-13,2020-10-19,ACTUAL,2020-10-15,ESTIMATED,2020-10-15,2020-10,2020-10-31,2023-05-30,ESTIMATED,2023-05-30,2023-05-30,ESTIMATED,2023-05-30,,INTERVENTIONAL,LEAP-SE,,Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram,"Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram (LEAP-SE): A Multicenter, Randomized, Blinded Outcome Study of EEG-guided Treatment With Sertraline Versus Escitalopram in Adults With Major Depressive Disorder",WITHDRAWN,,PHASE4,0.0,ACTUAL,Alto Neuroscience,,2.0,,No participants enrolled,f,,,,t,f,f,,,t,,,,,,UNDECIDED,,2024-10-15 09:16:04.300853,2024-10-15 09:16:04.300853,INDUSTRY,,,,,,,2023,0.0
NCT02408315,,2015-02-10,2019-05-22,,2022-03-28,2015-03-31,2015-04-03,ESTIMATED,2019-06-17,2019-07-09,ACTUAL,,,,2022-03-28,2022-04-13,ACTUAL,2015-09,,2015-09-30,2022-03,2022-03-31,2021-12,ACTUAL,2021-12-31,2017-11,ACTUAL,2017-11-30,,INTERVENTIONAL,IMPROVE,,Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE),Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium,COMPLETED,,PHASE3,300.0,ACTUAL,Indiana University,,2.0,,,f,,,,t,,,,,,,,After study completion and for 1 year after,Email contact to study contact.,,YES,Will share as needed for IPD.,2024-10-15 09:16:04.300853,2024-10-15 09:16:04.300853,OTHER,,,,,,,2021,1.0
NCT02956889,,2016-07-20,,,2020-01-27,2016-11-03,2016-11-06,ESTIMATED,,,,,,,2020-01-27,2020-01-29,ACTUAL,2016-10,ACTUAL,2016-10-31,2020-01,2020-01-31,2020-01,ACTUAL,2020-01-31,2019-02,ACTUAL,2019-02-28,,INTERVENTIONAL,virgilio,,To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Advanced Basal Cell Carcinoma,"A Single Arm, Phase II, Multicenter Study To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Patients With High Risk Or Locally Advanced Basal Cell Carcinoma Not Amenable To Radical Surgery",TERMINATED,,PHASE2,14.0,ACTUAL,Istituto Clinico Humanitas,,1.0,,low recruitment rate,f,,,,f,,,,,,,,,,,NO,not planned,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2020,0.0
NCT03521934,,2018-04-30,2022-09-30,2020-10-23,2022-09-30,2018-04-30,2018-05-11,ACTUAL,2022-09-30,2022-10-28,ACTUAL,2020-10-23,2020-10-28,ACTUAL,2022-09-30,2022-10-28,ACTUAL,2018-06-15,ACTUAL,2018-06-15,2022-09,2022-09-30,2020-06-05,ACTUAL,2020-06-05,2020-06-05,ACTUAL,2020-06-05,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all randomized participants.,Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial),"A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of Sotagliflozin on Clinical Outcomes in Hemodynamically Stable Patients With Type 2 Diabetes POST Worsening Heart Failure",TERMINATED,,PHASE3,1222.0,ACTUAL,Lexicon Pharmaceuticals,Limitations of the trial such as small numbers of participants analyzed or technical problems leading to unreliable data.~The study was terminated prematurely due to business decision.,2.0,,Study terminated due to business decision,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.",2024-10-15 09:22:03.909866,2024-10-15 09:22:03.909866,INDUSTRY,,,,,,,2020,0.0
NCT03714867,,2018-10-19,,,2020-07-07,2018-10-19,2018-10-22,ACTUAL,,,,,,,2020-07-07,2020-07-09,ACTUAL,2019-03-22,ACTUAL,2019-03-22,2020-07,2020-07-31,2020-07-07,ACTUAL,2020-07-07,2020-07-07,ACTUAL,2020-07-07,,INTERVENTIONAL,,,Pre-Operative Pregabalin for Post-Operative Pain in Head and Neck Cancer Surgery,"Use of Single Dose Pre-Operative Pregabalin for Post-Operative Analgesia in Bilateral Head and Neck Cancer Surgery: A Randomized, Double-Blinded, Placebo-Controlled Trial",WITHDRAWN,,PHASE4,0.0,ACTUAL,Augusta University,,2.0,,Inability to recruit patients,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 09:22:03.909866,2024-10-15 09:22:03.909866,OTHER,,,,,,,2020,0.0
NCT04335461,,2020-04-03,,,2023-07-12,2020-04-03,2020-04-06,ACTUAL,,,,,,,2023-07-12,2023-07-13,ACTUAL,2021-08-05,ACTUAL,2021-08-05,2023-07,2023-07-31,2023-03-17,ACTUAL,2023-03-17,2023-03-17,ACTUAL,2023-03-17,,INTERVENTIONAL,,,Postop Pain Control in Hip Fracture Surgery: Fascia Iliaca Compartment Block Versus Fracture Block,Postoperative Pain Control in Extracapsular Hip Fracture Patients: Fascia Iliaca Compartment Block Versus Fracture Block,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Montefiore Medical Center,,3.0,,Study was withdrawn. Study expired in IRB system and no patients enrolled as per institutional CTMS and IRB systems. Primary and Study Completion Dates reflect date IRB approval expired.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 09:22:03.909866,2024-10-15 09:22:03.909866,OTHER,,,,,,,2023,0.0
NCT03851705,,2019-02-07,2022-09-06,2020-11-11,2023-01-27,2019-02-20,2019-02-22,ACTUAL,2022-10-14,2022-11-10,ACTUAL,2022-10-14,2022-11-10,ACTUAL,2023-01-27,2023-01-30,ACTUAL,2019-02-06,ACTUAL,2019-02-06,2023-01,2023-01-31,2021-09-09,ACTUAL,2021-09-09,2020-03-02,ACTUAL,2020-03-02,,INTERVENTIONAL,ORION-5,,A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH),"A Two-Part (Double-Blind Placebo Controlled/Open-Label) Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Subjects With Homozygous Familial Hypercholesterolemia (Hofh) (ORION-5)",COMPLETED,,PHASE3,56.0,ACTUAL,Novartis,,3.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-15 09:22:03.909866,2024-10-15 09:22:03.909866,INDUSTRY,,,,,,,2021,1.0
NCT05457530,,2022-04-15,,,2023-05-10,2022-07-12,2022-07-14,ACTUAL,,,,,,,2023-05-10,2023-05-12,ACTUAL,2022-08-01,ACTUAL,2022-08-01,2023-05,2023-05-31,2023-05-03,ACTUAL,2023-05-03,2023-05-03,ACTUAL,2023-05-03,,INTERVENTIONAL,DAWN,,Doravirine and Weight Gain in Antiretroviral Naive,"Effect of Modified, Rapid-start, DOR/3TC/TDF or DOR + FTC/TAF or BIC/FTC/TAF on Body Weight and Composition, Metabolic Risk Parameters, and Measures of Bone Strength in Treatment-Naïve Black and Hispanic Women With HIV-1 Infection",WITHDRAWN,,PHASE3,0.0,ACTUAL,Prism Health North Texas,,3.0,,Due to No/Low enrollment,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2023,0.0
NCT04767373,,2021-02-22,,,2024-07-15,2021-02-22,2021-02-23,ACTUAL,,,,,,,2024-07-15,2024-07-16,ACTUAL,2021-04-07,ACTUAL,2021-04-07,2024-07,2024-07-31,2024-07-09,ACTUAL,2024-07-09,2024-07-09,ACTUAL,2024-07-09,,INTERVENTIONAL,,,Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004),"A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants",COMPLETED,,PHASE2/PHASE3,3632.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 09:22:03.909866,2024-10-15 09:22:03.909866,INDUSTRY,,,,,,,2024,1.0
NCT05218096,,2021-12-16,,,2024-07-16,2022-01-28,2022-02-01,ACTUAL,,,,,,,2024-07-16,2024-07-17,ACTUAL,2022-04-27,ACTUAL,2022-04-27,2024-07,2024-07-31,2024-04-03,ACTUAL,2024-04-03,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,,,Study of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis",TERMINATED,,PHASE2,70.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,3.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,YES,"Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.",2024-10-15 09:22:03.909866,2024-10-15 09:22:03.909866,INDUSTRY,,,,,,,2024,0.0
NCT03919799,,2018-11-21,2023-08-04,,2023-08-04,2019-04-17,2019-04-18,ACTUAL,2023-08-04,2023-08-30,ACTUAL,,,,2023-08-04,2023-08-30,ACTUAL,2019-06-26,ACTUAL,2019-06-26,2023-08,2023-08-31,2023-02-17,ACTUAL,2023-02-17,2022-08-09,ACTUAL,2022-08-09,,INTERVENTIONAL,,Analysis was performed on modified intent-to-treat (mITT) population which included all participants who received at least one dose of the study drug.,KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis,"A Phase 2, Randomized, Placebo-controlled, Double-blind, Open-label Extension Multicenter Study to Evaluate the Efficacy and Safety of Belumosudil (KD025) in Subjects With Diffuse Cutaneous Systemic Sclerosis",TERMINATED,,PHASE2,36.0,ACTUAL,Sanofi,The study was terminated early by the Sponsor due to slow enrollment and strategic consideration and was not driven due to any safety concerns.,5.0,,Sponsor decision due to slow enrollment and strategic consideration; not driven by any safety concerns.,,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 09:22:03.909866,2024-10-15 09:22:03.909866,INDUSTRY,,,,,,,2023,0.0
NCT05363644,,2022-04-25,,,2023-06-28,2022-05-02,2022-05-06,ACTUAL,,,,,,,2023-06-28,2023-06-29,ACTUAL,2023-04-01,ESTIMATED,2023-04-01,2023-06,2023-06-30,2024-06-30,ESTIMATED,2024-06-30,2023-12-31,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy,Treatment Protocol With BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy: A Prospective Open Label Single-Center Study,WITHDRAWN,,PHASE3,0.0,ACTUAL,AdventHealth,,1.0,,Study was withdrawn due to lack of funding,f,,,,f,t,f,,,t,,,,,,NO,De-identified information may be utilized in teachings and/or publication as it related to this research.,2024-10-15 09:22:03.909866,2024-10-15 09:22:03.909866,OTHER,,,,,,,2024,0.0
NCT03692780,,2018-09-25,,,2018-12-13,2018-09-30,2018-10-02,ACTUAL,,,,,,,2018-12-13,2018-12-17,ACTUAL,2019-03,ESTIMATED,2019-03-31,2018-12,2018-12-31,2021-06,ESTIMATED,2021-06-30,2021-03,ESTIMATED,2021-03-31,,INTERVENTIONAL,,,Careseng 1370 for Chemotherapy-Induced Myelosuppression,"A Phase I Dose-Finding Followed by Phase IIa Randomized, Double-Blind, Placebo-Controlled, Parallel, Add-on to Cisplatin Plus Docetaxel Study to Evaluate the Safety, Tolerability and Efficacy Profiles of Careseng 1370 to Treat Chemotherapy-Induced Myelosuppression in Advanced Non-Small Cell Lung Cancer (NSCLC) Subjects",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Careseng Biotech Co., Ltd.",,2.0,,At sponsor's discretion,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,INDUSTRY,,,,,,,2021,0.0
NCT03903822,,2019-03-20,2021-01-20,,2021-03-03,2019-04-02,2019-04-04,ACTUAL,2021-03-03,2021-03-29,ACTUAL,,,,2021-03-03,2021-03-29,ACTUAL,2019-05-13,ACTUAL,2019-05-13,2021-03,2021-03-31,2020-05-07,ACTUAL,2020-05-07,2020-05-07,ACTUAL,2020-05-07,,INTERVENTIONAL,,Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug.,"Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis","A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 CREAM APPLIED ONCE OR TWICE DAILY FOR 6 WEEKS IN PARTICIPANTS WITH MILD OR MODERATE ATOPIC DERMATITIS",COMPLETED,,PHASE2,292.0,ACTUAL,Pfizer,,8.0,,,f,,,,t,t,f,,,,,,,,,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests,2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,INDUSTRY,,,,,,,2020,1.0
NCT04382651,,2020-05-08,2022-04-05,2021-07-07,2022-08-08,2020-05-08,2020-05-11,ACTUAL,2022-04-05,2022-04-20,ACTUAL,2021-07-07,2021-07-08,ACTUAL,2022-08-08,2022-08-10,ACTUAL,2020-06-11,ACTUAL,2020-06-11,2022-08,2022-08-31,2021-04-21,ACTUAL,2021-04-21,2021-01-06,ACTUAL,2021-01-06,,INTERVENTIONAL,MAS-COVID,,Study of Efficacy and Safety of MAS825 in Patients With COVID-19,"A Phase 2, Randomized, Placebo-controlled, Participant and Investigator Blinded, Multi-center Study to Assess Efficacy and Safety of MAS825 for the Treatment of SARS-CoV-2 Infected Patients With COVID-19 Pneumonia and Impaired Respiratory Function",COMPLETED,,PHASE2,140.0,ACTUAL,Novartis,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,INDUSTRY,,,,,,,2021,1.0
NCT03761953,,2018-11-09,,,2022-03-28,2018-11-30,2018-12-03,ACTUAL,,,,,,,2022-03-28,2022-04-06,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2022-03,2022-03-31,2022-03-24,ACTUAL,2022-03-24,2022-03-24,ACTUAL,2022-03-24,,INTERVENTIONAL,,,Oritavancin for Staphylococcus Aureus Infections in Opioid Users,A Pilot Proof of Concept Single-Center Study of the Use of Oritavancin in Systemic Staphylococcus Aureus Infections in Patients With Opioid Use Disorder,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Pennsylvania,,1.0,,COVID 19 pandemic,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2022,0.0
NCT03103750,,2017-03-30,2023-12-11,,2024-02-20,2017-03-30,2017-04-06,ACTUAL,2024-02-20,2024-03-19,ACTUAL,,,,2024-02-20,2024-03-19,ACTUAL,2017-08-15,ACTUAL,2017-08-15,2024-02,2024-02-29,2023-01-17,ACTUAL,2023-01-17,2023-01-17,ACTUAL,2023-01-17,,INTERVENTIONAL,,Overall sample prior to randomization to crossover sequence.,Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD,Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD: a Proof-of-concept Study of Stimulant-induced Dopamine Release Using [11C]-PHNO PET in Healthy Humans,COMPLETED,,PHASE1,24.0,ACTUAL,Yale University,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2023,1.0
NCT04826432,,2021-03-29,,,2024-02-07,2021-03-29,2021-04-01,ACTUAL,,,,,,,2024-02-07,2024-02-08,ACTUAL,2020-09-03,ACTUAL,2020-09-03,2024-02,2024-02-29,2024-02-07,ACTUAL,2024-02-07,2024-02-07,ACTUAL,2024-02-07,,INTERVENTIONAL,PASIREOCHIP,,Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis,Efficacy and Feasibility of Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis - a Phase II Randomized Multicentric Trial,TERMINATED,,PHASE2,6.0,ACTUAL,"Gustave Roussy, Cancer Campus, Grand Paris",,2.0,,No more experimental drugs available,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 09:22:03.909866,2024-10-15 09:22:03.909866,OTHER,,,,,,,2024,0.0
NCT03658109,,2018-08-13,,,2021-05-05,2018-08-31,2018-09-05,ACTUAL,,,,,,,2021-05-05,2021-05-10,ACTUAL,2019-09-24,ACTUAL,2019-09-24,2021-05,2021-05-31,2021-05-04,ACTUAL,2021-05-04,2021-05-04,ACTUAL,2021-05-04,,INTERVENTIONAL,,,"Lidocaine Infusion or Quadratus Lumborum Block and Intrathecal Morphine, Versus Intrathecal Morphine Alone",Systemic Lidocaine Infusion or Quadratus Lumborum Block (in Addition to Intrathecal Morphine) Versus Intrathecal Morphine Alone as Part of a Gynecology-Oncology Surgery Early Recovery Protocol,TERMINATED,,EARLY_PHASE1,1.0,ACTUAL,University of Alabama at Birmingham,,3.0,,Recruitment challenges due to COVID-19,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,OTHER,,,,,,,2021,0.0
NCT03996252,,2019-06-20,,,2020-12-03,2019-06-20,2019-06-24,ACTUAL,,,,,,,2020-12-03,2020-12-07,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2020-12,2020-12-31,2020-06-08,ACTUAL,2020-06-08,2020-01-01,ACTUAL,2020-01-01,,INTERVENTIONAL,,,Combination Topical Therapy for Treatment of Scalp Actinic Keratoses,Combination Calcipotriene 0.005% Foam and Fluorouracil 5% Cream for the Treatment of Actinic Keratoses on the Scalp,TERMINATED,,EARLY_PHASE1,15.0,ACTUAL,Tulane University,,1.0,,"The study team was not able to start the study and they never completed the IRB submission, so the study was terminated.",f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 09:22:03.909866,2024-10-15 09:22:03.909866,OTHER,,,,,,,2020,0.0
NCT03502746,,2018-04-11,2023-09-01,,2024-04-18,2018-04-18,2018-04-19,ACTUAL,2023-10-24,2023-10-26,ACTUAL,,,,2024-04-18,2024-05-14,ACTUAL,2018-06-26,ACTUAL,2018-06-26,2024-04,2024-04-30,2023-11-09,ACTUAL,2023-11-09,2022-05-11,ACTUAL,2022-05-11,,INTERVENTIONAL,,,Phase II Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma,Phase II Study of Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma:Hoosier Cancer Research Network LUN15-299,TERMINATED,,PHASE2,34.0,ACTUAL,Hoosier Cancer Research Network,,1.0,,IRB Study Closure,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2023,0.0
NCT02468232,,2015-06-08,2022-02-17,,2023-03-13,2015-06-08,2015-06-10,ESTIMATED,2023-03-13,2023-12-08,ACTUAL,,,,2023-03-13,2023-12-08,ACTUAL,2015-06-15,ACTUAL,2015-06-15,2023-03,2023-03-31,2021-02-18,ACTUAL,2021-02-18,2019-02-08,ACTUAL,2019-02-08,,INTERVENTIONAL,PARALLEL-HF,"The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization (mis-randomized) and have not received investigational drug, but have been inadvertently randomized into the study.",Study of Efficacy and Safety of LCZ696 in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction,"A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction.",COMPLETED,,PHASE3,225.0,ACTUAL,Novartis,,2.0,,,f,,,,t,f,f,,,,,,,,https://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 09:22:03.909866,2024-10-15 09:22:03.909866,INDUSTRY,,,,,,,2021,1.0
NCT03220178,,2017-07-06,,,2021-12-16,2017-07-14,2017-07-18,ACTUAL,,,,,,,2021-12-16,2022-01-06,ACTUAL,2017-07-24,ACTUAL,2017-07-24,2021-12,2021-12-31,2021-12-07,ACTUAL,2021-12-07,2021-12-07,ACTUAL,2021-12-07,,INTERVENTIONAL,PRECYCLE,,Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy,"PRECYCLE: Multicenter, Randomized Phase IV Intergroup Trial to Evaluate the Impact of eHealth-based Patient Reported Outcome (PRO) Assessment on Quality of Life in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib and an Aromatase Inhibitor- or Palbociclib and Fulvestrant",TERMINATED,,PHASE4,532.0,ACTUAL,Palleos Healthcare GmbH,,2.0,,"Due to COVID-19 pandemic, study cannot be finished in planned timeframe.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 09:22:03.909866,2024-10-15 09:22:03.909866,INDUSTRY,,,,,,,2021,0.0
NCT03164993,,2017-05-12,,,2024-10-09,2017-05-22,2017-05-24,ACTUAL,,,,,,,2024-10-09,2024-10-15,ACTUAL,2017-06-01,ACTUAL,2017-06-01,2023-10,2023-10-31,2023-09-30,ACTUAL,2023-09-30,2023-04-25,ACTUAL,2023-04-25,,INTERVENTIONAL,ALICE,,Atezolizumab Combined with Immunogenic Chemotherapy in Patients with Metastatic Triple-negative Breast Cancer,ALICE: a Randomized Placebo-controlled Phase II Study Evaluating Atezolizumab Combined with Immunogenic Chemotherapy in Patients with Metastatic Triple-negative Breast Cancer,COMPLETED,,PHASE2,68.0,ACTUAL,Oslo University Hospital,,2.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-17 04:24:16.629849,2024-10-17 04:24:16.629849,OTHER,,,,,,,2023,1.0
NCT04212650,,2019-12-19,2023-06-26,,2023-10-25,2019-12-24,2019-12-27,ACTUAL,2023-10-25,2023-10-30,ACTUAL,,,,2023-10-25,2023-10-30,ACTUAL,2020-08-07,ACTUAL,2020-08-07,2023-10,2023-10-31,2020-12-04,ACTUAL,2020-12-04,2020-12-04,ACTUAL,2020-12-04,,INTERVENTIONAL,,One (1) participant was enrolled in the study and subsequently randomized to the Losartan arm.,Losartan to Improve Hip Microfracture,"Biologically Regulated Marrow Stimulation by Blocking Fibrosis to Improve Cartilage Repair: A Randomized Double-Blind, Placebo-Controlled Study",TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,Steadman Philippon Research Institute,"Per opinion of the Principal Investigator, Losartan is now clinically indicated as a standard of care post-operative therapy for patients undergoing hip microfracture surgeries. The study was terminated early, resulting in a singular subject enrolled for data analysis. The subject elected to withdraw from the study prior to the first follow-up data collection timepoint.",2.0,,redesigned trial using another placebo controlled drug,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 09:22:03.909866,2024-10-15 09:22:03.909866,OTHER,,,,,,,2020,0.0
NCT03228186,,2017-07-21,2022-12-12,,2023-10-05,2017-07-21,2017-07-24,ACTUAL,2023-10-05,2023-10-23,ACTUAL,,,,2023-10-05,2023-10-23,ACTUAL,2018-03-05,ACTUAL,2018-03-05,2023-10,2023-10-31,2021-11-04,ACTUAL,2021-11-04,2021-11-04,ACTUAL,2021-11-04,,INTERVENTIONAL,,9 patients were screen failed,Trial of Pevonedistat Plus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer,Phase II Trial of Pevonedistat (TAK-924) Plus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer,TERMINATED,,PHASE2,40.0,ACTUAL,University of Michigan Rogel Cancer Center,,1.0,,Pharmaceutical company discontinued the study drug.,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2021,0.0
NCT04902950,,2021-05-10,2022-04-26,,2023-04-23,2021-05-25,2021-05-26,ACTUAL,2023-04-23,2023-04-25,ACTUAL,,,,2023-04-23,2023-04-25,ACTUAL,2020-08-17,ACTUAL,2020-08-17,2023-04,2023-04-30,2021-05-06,ACTUAL,2021-05-06,2021-05-06,ACTUAL,2021-05-06,,INTERVENTIONAL,,,TXA in the Reduction of Post-Op Hematoma and Seroma in Patients Undergoing Panniculectomy or Abdominoplasty,"Role of Tranexamic Acid (TXA) in the Reduction of Post-operative Hematoma and Seroma in Patients Undergoing Panniculectomy or Abdominoplasty, a Pilot Study.",TERMINATED,,PHASE4,9.0,ACTUAL,The Reading Hospital and Medical Center,,2.0,,Logistics,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2021,0.0
NCT04933240,,2021-06-14,,,2022-05-31,2021-06-14,2021-06-21,ACTUAL,,,,,,,2022-05-31,2022-06-03,ACTUAL,2022-05,ESTIMATED,2022-05-31,2022-05,2022-05-31,2024-12,ESTIMATED,2024-12-31,2024-06,ESTIMATED,2024-06-30,,INTERVENTIONAL,,,"Tamoxifen Versus Estradiol for Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Pilot Trial","Tamoxifen Versus Estradiol in the Prevention of Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Controlled Pilot Trial",WITHDRAWN,,PHASE4,0.0,ACTUAL,Virginia Commonwealth University,,3.0,,Anticipated funding was not received,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 16:43:55.4698,2024-10-16 16:43:55.4698,OTHER,,,,,,,2024,0.0
NCT03598777,,2018-06-08,2021-10-22,,2021-12-08,2018-07-18,2018-07-26,ACTUAL,2021-12-08,2021-12-09,ACTUAL,,,,2021-12-08,2021-12-09,ACTUAL,2018-06-11,ACTUAL,2018-06-11,2021-10,2021-10-31,2021-01-21,ACTUAL,2021-01-21,2021-01-21,ACTUAL,2021-01-21,,INTERVENTIONAL,DYVINIA,All randomised participants were included in the baseline analysis.,Dysport in Vulvodynia Phase II Study,"A Phase II, Multicentre, Double-blind, Randomised, Placebo Controlled, Dose Escalation and Dose Finding Study to Evaluate the Efficacy and Safety of Dysport in Vulvodynia Patients",TERMINATED,,PHASE2,60.0,ACTUAL,Ipsen,"After all participants completed Week 12, a Data Review Committee (DRC) recommended: No safety concerns noted in review of all available data. Efficacy cannot be assessed due to the small sample size of cohorts. The DRC would recommend that Stage 1 is not used to make an efficacy assessment; therefore, there is no justification to increase the dose, nor to move to Stage 2. Thus, sponsor terminated the study early; the decision was not related to any safety/tolerability concerns with Dysport.",3.0,,lack of efficacy,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,INDUSTRY,,,,,,,2021,0.0
NCT04723537,,2021-01-18,2024-01-18,,2024-05-07,2021-01-21,2021-01-25,ACTUAL,2024-05-07,2024-06-06,ACTUAL,,,,2024-05-07,2024-06-06,ACTUAL,2021-02-16,ACTUAL,2021-02-16,2024-03,2024-03-31,2021-12-28,ACTUAL,2021-12-28,2021-12-28,ACTUAL,2021-12-28,,INTERVENTIONAL,,,"Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease","Phase 2/3 Study of Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease",TERMINATED,,PHASE2/PHASE3,61.0,ACTUAL,RedHill Biopharma Limited,,5.0,,Part A complete; corporate decision made to cancel Part B.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,INDUSTRY,,,,,,,2021,0.0
NCT01673867,,2012-08-24,2016-01-29,,2023-01-13,2012-08-24,2012-08-28,ESTIMATED,2016-01-29,2016-02-26,ESTIMATED,,,,2023-01-13,2023-02-08,ACTUAL,2012-11-02,ACTUAL,2012-11-02,2023-01,2023-01-31,2021-12-17,ACTUAL,2021-12-17,2015-02-05,ACTUAL,2015-02-05,,INTERVENTIONAL,CheckMate057,All randomized participants,Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC,An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC),COMPLETED,,PHASE3,582.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,t,,,,f,t,f,,,,,,,,,,,2024-10-15 09:22:03.909866,2024-10-15 09:22:03.909866,INDUSTRY,,NCT03126643,APPROVED_FOR_MARKETING,,,,2021,1.0
NCT04502472,,2020-08-04,2021-10-04,,2022-01-05,2020-08-04,2020-08-06,ACTUAL,2022-01-05,2022-01-10,ACTUAL,,,,2022-01-05,2022-01-10,ACTUAL,2020-06-06,ACTUAL,2020-06-06,2022-01,2022-01-31,2020-09-30,ACTUAL,2020-09-30,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,Inova-CCP,,Treatment of Severe Coronavirus Disease 2019 (COVID-19) With Convalescent Plasma,Treatment of Severe Coronavirus Disease 2019 (COVID-19) With Convalescent Plasma Collected From Individuals With Documented Infection and Recovery From COVID-19 (SARS-CoV-2),TERMINATED,,PHASE2/PHASE3,109.0,ACTUAL,Inova Health Care Services,,1.0,,FDA gave emergency use approval to COVID-19 convalescent plasma on 08/24/2020,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,OTHER,,,,,,,2020,0.0
NCT05184218,,2022-01-06,,,2022-10-12,2022-01-06,2022-01-11,ACTUAL,,,,,,,2022-10-12,2022-10-14,ACTUAL,2022-01-20,ACTUAL,2022-01-20,2022-10,2022-10-31,2022-07-04,ACTUAL,2022-07-04,2022-05-06,ACTUAL,2022-05-06,,INTERVENTIONAL,,,Evaluation of IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19,"A Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Intranasal Plus Intraoral IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19",TERMINATED,,PHASE1,26.0,ACTUAL,"IGM Biosciences, Inc.",,7.0,,Sponsor Decision,f,,,,t,f,f,,,t,,,,,,,,2024-10-15 09:22:03.909866,2024-10-15 09:22:03.909866,INDUSTRY,,,,,,,2022,0.0
NCT04388709,,2020-05-12,,,2021-02-24,2020-05-12,2020-05-14,ACTUAL,,,,,,,2021-02-24,2021-02-26,ACTUAL,2020-09,ESTIMATED,2020-09-30,2021-02,2021-02-28,2021-02-05,ACTUAL,2021-02-05,2021-02-05,ACTUAL,2021-02-05,,INTERVENTIONAL,,,Interferon Lambda Therapy for COVID-19,A Randomized Phase 2 Trial of Peginterferon Lambda-1a (Lambda) for the Treatment of Hospitalized Patients Infected With SARS-CoV-2 With Non-critical Illness,WITHDRAWN,,PHASE2,0.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,2.0,,"Due to the number of competing trials at their site, the study team has closed enrollment and withdrawn this trial.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:22:03.909866,2024-10-15 09:22:03.909866,OTHER,,,,,,,2021,0.0
NCT03453541,,2018-02-27,,,2024-10-10,2018-02-27,2018-03-05,ACTUAL,,,,,,,2024-10-10,2024-10-15,ACTUAL,2017-11-21,ACTUAL,2017-11-21,2021-09,2021-09-30,2022-11-01,ACTUAL,2022-11-01,2022-11-01,ACTUAL,2022-11-01,,INTERVENTIONAL,,,Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy,"A Randomized, Double-blinded, Placebo-controlled Study of Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy",TERMINATED,,PHASE4,214.0,ACTUAL,Albany Medical College,,2.0,,Limited recruitment resources.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 04:24:16.629849,2024-10-17 04:24:16.629849,OTHER,,,,,,,2022,0.0
NCT01541215,,2012-02-23,2018-11-15,,2021-07-01,2012-02-28,2012-02-29,ESTIMATED,2018-11-15,2018-12-11,ACTUAL,,,,2021-07-01,2021-07-02,ACTUAL,2012-11-13,ACTUAL,2012-11-13,2021-07,2021-07-31,2020-05-20,ACTUAL,2020-05-20,2017-11-15,ACTUAL,2017-11-15,,INTERVENTIONAL,Ellipse™,Full analysis set (FAS) - included all randomised subjects receiving at least one dose of liraglutide/placebo,"Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes",Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes,COMPLETED,,PHASE3,135.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com/sharing-results,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 16:43:55.4698,2024-10-16 16:43:55.4698,INDUSTRY,,,,,,,2020,1.0
NCT04115839,,2019-10-02,2021-12-30,,2022-02-18,2019-10-02,2019-10-04,ACTUAL,2022-02-18,2022-03-18,ACTUAL,,,,2022-02-18,2022-03-18,ACTUAL,2019-11-13,ACTUAL,2019-11-13,2022-02,2022-02-28,2021-03-18,ACTUAL,2021-03-18,2021-01-04,ACTUAL,2021-01-04,,INTERVENTIONAL,PENGUIN 2,Safety Analysis Set included all participants who received at least 1 dose of study drug.,Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy,"A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy",TERMINATED,,PHASE3,106.0,ACTUAL,Gilead Sciences,,5.0,,Development program terminated,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,INDUSTRY,,,,,,,2021,0.0
NCT02422615,,2015-04-01,2018-08-18,,2023-11-02,2015-04-16,2015-04-21,ESTIMATED,2018-08-18,2018-09-19,ACTUAL,,,,2023-11-02,2023-11-30,ACTUAL,2015-06-09,ACTUAL,2015-06-09,2023-11,2023-11-30,2023-01-11,ACTUAL,2023-01-11,2017-11-03,ACTUAL,2017-11-03,,INTERVENTIONAL,MONALEESA-3,,Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.,"A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment",COMPLETED,,PHASE3,726.0,ACTUAL,Novartis,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.",2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,INDUSTRY,,,,,,,2023,1.0
NCT04162639,,2019-11-11,,,2021-03-16,2019-11-11,2019-11-14,ACTUAL,,,,,,,2021-03-16,2021-03-19,ACTUAL,2021-02,ESTIMATED,2021-02-28,2021-03,2021-03-31,2023-02,ESTIMATED,2023-02-28,2023-02,ESTIMATED,2023-02-28,,INTERVENTIONAL,,,The Relationship Between Cadaveric Allograft Skin and HLA-Sensitivity in Burn Patients,The Relationship Between Cadaveric Allograft Skin and Human-leukocyte Antigens (HLA)-Sensitivity in Burn Patients,WITHDRAWN,,PHASE4,0.0,ACTUAL,Virginia Commonwealth University,,4.0,,PI is working on getting funding for the study and wishes to withdraw the study until that funding is secured.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,OTHER,,,,,,,2023,0.0
NCT04134468,,2019-10-18,,,2020-01-30,2019-10-18,2019-10-22,ACTUAL,,,,,,,2020-01-30,2020-01-31,ACTUAL,2020-01,ESTIMATED,2020-01-31,2020-01,2020-01-31,2022-11-11,ESTIMATED,2022-11-11,2021-02-11,ESTIMATED,2021-02-11,,INTERVENTIONAL,,,MRI Effects of Pegvorhyaluronidase Alfa (PEGPH20) in Pancreatic Ductal Adenocarcinoma,UPCC 10219: Phase II Study Of Stromal Changes Detected By DCE- and DW-MRI In Response To PEGPH20 Combined With Chemotherapy In Subjects With Locally-Advanced Pancreatic Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,Abramson Cancer Center at Penn Medicine,,1.0,,Halozyme halted development of PEGPH20 following Phase 3 failure.,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,OTHER,,,,,,,2022,0.0
NCT01622868,,2012-06-15,2021-02-10,,2023-09-22,2012-06-15,2012-06-19,ESTIMATED,2021-03-18,2021-04-13,ACTUAL,,,,2023-09-22,2023-10-17,ACTUAL,2012-12-06,ACTUAL,2012-12-06,2023-09,2023-09-30,2022-05-20,ACTUAL,2022-05-20,2019-12-30,ACTUAL,2019-12-30,,INTERVENTIONAL,,Eligible participants,Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer,Phase II Randomized Study of Whole Brain Radiotherapy/Stereotactic Radiosurgery in Combination With Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer - A Collaborative Study of NRG Oncology and KROG,COMPLETED,,PHASE2,143.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,NIH,,,,,,,2022,1.0
NCT04044651,,2019-07-31,,,2020-01-06,2019-08-01,2019-08-05,ACTUAL,,,,,,,2020-01-06,2020-01-09,ACTUAL,2019-10-30,ESTIMATED,2019-10-30,2020-01,2020-01-31,2022-09-30,ESTIMATED,2022-09-30,2021-03-30,ESTIMATED,2021-03-30,,INTERVENTIONAL,,,Lenvatinib Plus Nivolumab Versus Lenvatinib for Advanced Hepatocellular Carcinoma With Hepatitis B Virus Infection,"A Randomized, Phase IIb Study of Lenvatinib Plus Nivolumab Versus Lenvatinib for Advanced Hepatocellular Carcinoma (HCC) With Hepatitis B Virus (HBV) Infection",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Sun Yat-sen University,,2.0,,Bristol-Myers Squibb company terminated this study,f,,,,t,f,f,,,,,,,,,,,2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,OTHER,,,,,,,2022,0.0
NCT04799431,,2021-03-11,,,2023-05-05,2021-03-11,2021-03-16,ACTUAL,,,,,,,2023-05-05,2023-05-09,ACTUAL,2023-05-03,ACTUAL,2023-05-03,2023-05,2023-05-31,2023-05-03,ACTUAL,2023-05-03,2023-05-03,ACTUAL,2023-05-03,,INTERVENTIONAL,,,Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colon and Pancreatic Ductal Cancer,A Pilot Study of a Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Adenocarcinoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,Study never started,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,OTHER,,,,,,,2023,0.0
NCT02990338,,2016-12-04,2019-11-19,,2023-11-14,2016-12-08,2016-12-13,ESTIMATED,2019-11-19,2019-12-06,ACTUAL,,,,2023-11-14,2023-11-18,ACTUAL,2016-12-22,ACTUAL,2016-12-22,2023-11,2023-11-30,2023-11-01,ACTUAL,2023-11-01,2018-11-22,ACTUAL,2018-11-22,,INTERVENTIONAL,ICARIA-MM,"Analysis was performed on randomized population which included all participants with a signed informed consent and have been allocated a randomization number by the IRT, regardless of whether the participants was treated or not.","Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients","A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination With Pomalidomide and Low-Dose Dexamethasone Versus Pomalidomide and Low-Dose Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma",COMPLETED,,PHASE3,307.0,ACTUAL,Sanofi,,2.0,,,f,,,,t,t,,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,INDUSTRY,,,,,,,2023,1.0
NCT03573544,,2018-05-07,2023-09-13,,2024-02-20,2018-06-19,2018-06-29,ACTUAL,2024-02-20,2024-02-22,ACTUAL,,,,2024-02-20,2024-02-22,ACTUAL,2018-05-07,ACTUAL,2018-05-07,2024-02,2024-02-29,2022-04-07,ACTUAL,2022-04-07,2022-04-07,ACTUAL,2022-04-07,,INTERVENTIONAL,,The safety population consisted of all enrolled subjects who received at least 1 dose of study drug.,This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.,"A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.",TERMINATED,,PHASE1/PHASE2,54.0,ACTUAL,"OBI Pharma, Inc",,2.0,,OBI-888 no longer fulfills our goal of developing cost-effective therapies for cancer patients,f,,,,f,t,t,,,,,,,,,UNDECIDED,,2024-10-16 16:43:55.4698,2024-10-16 16:43:55.4698,INDUSTRY,,,,,,,2022,0.0
NCT05590403,,2022-10-18,2024-03-13,,2024-04-25,2022-10-18,2022-10-21,ACTUAL,2024-04-25,2024-05-21,ACTUAL,,,,2024-04-25,2024-05-21,ACTUAL,2022-10-28,ACTUAL,2022-10-28,2024-04,2024-04-30,2024-04-03,ACTUAL,2024-04-03,2023-03-13,ACTUAL,2023-03-13,,INTERVENTIONAL,,,"A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above","A Phase 3, Observer-blind, Randomized, Placebo-controlled Study to Evaluate the Non-inferiority of the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults ≥60 Years of Age",COMPLETED,,PHASE3,1544.0,ACTUAL,GlaxoSmithKline,,5.0,,,f,,,,f,t,f,,,f,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,INDUSTRY,,,,,,,2024,1.0
NCT05581719,,2022-10-12,,,2024-04-15,2022-10-12,2022-10-14,ACTUAL,,,,,,,2024-04-15,2024-04-17,ACTUAL,2022-11-15,ACTUAL,2022-11-15,2024-04,2024-04-30,2024-04-15,ACTUAL,2024-04-15,2024-04-15,ACTUAL,2024-04-15,,INTERVENTIONAL,,,A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy,A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy,TERMINATED,,PHASE1/PHASE2,14.0,ACTUAL,Enlivex Therapeutics RDO Ltd.,,3.0,,Sponsor decision,f,,,,,f,f,,,,,,,,,,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,INDUSTRY,,,,,,,2024,0.0
NCT05512182,,2022-08-10,,,2023-06-12,2022-08-22,2022-08-23,ACTUAL,,,,,,,2023-06-12,2023-06-15,ACTUAL,2022-09-15,ESTIMATED,2022-09-15,2023-06,2023-06-30,2023-10-30,ESTIMATED,2023-10-30,2023-10-30,ESTIMATED,2023-10-30,,INTERVENTIONAL,,,"Efficacy of Triplet Combination With Pembrolizumab, Neratinib, and Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer Having Somatic Human Epidermal Growth Factor Receptor Family (EGFR, HER2, HER3, HER4) Mutations or HER2 Amplification/Overexpression","An Open Label, Single-Arm, Multi-Center Phase II Study to Evaluate the Efficacy of Triplet Combination With Pembrolizumab, Neratinib, and Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer Having Somatic Human Epidermal Growth Factor Receptor Family (EGFR, HER2, HER3, HER4) Mutations or HER2 Amplification/Overexpression",WITHDRAWN,,PHASE2,0.0,ACTUAL,Yonsei University,,1.0,,No participants enrolled,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 18:33:39.100959,2024-10-15 18:33:39.100959,OTHER,,,,,,,2023,0.0
NCT03440112,,2018-01-26,2022-09-15,,2022-12-15,2018-02-13,2018-02-20,ACTUAL,2022-12-15,2023-01-10,ACTUAL,,,,2022-12-15,2023-01-10,ACTUAL,2018-01-29,ACTUAL,2018-01-29,2022-12,2022-12-31,2021-12-08,ACTUAL,2021-12-08,2021-12-08,ACTUAL,2021-12-08,,INTERVENTIONAL,GABA-A,"Parkinson's disease patients age 50 years or older. Some, but not all, participants in the Clarithromycin arm were randomized, and only few completed study procedures because of premature termination of the trial due to an FDA safety risk warning of Clarithromycin, precluding any meaningful analysis. Consequently, this study arm was replaced by the transdermal Flumazenil arm.",Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm,Modulation of GABA-A Receptors and Axial Motor Impairments in Parkinson,COMPLETED,,PHASE1/PHASE2,34.0,ACTUAL,University of Michigan,"Our participants were predominantly male, which is often the case with Parkinson's disease (PD) patient population since PD is known to affect males at a greater rate. This means that our findings may not generalize as well to population of female PD patients.",4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2021,1.0
NCT03777956,,2018-12-14,,,2023-02-15,2018-12-14,2018-12-19,ACTUAL,,,,,,,2023-02-15,2023-02-16,ACTUAL,2019-01-15,ACTUAL,2019-01-15,2023-02,2023-02-28,2022-06-03,ACTUAL,2022-06-03,2022-06-03,ACTUAL,2022-06-03,,INTERVENTIONAL,,,The Effect of Lacosamide in Peripheral Neuropathic Pain,"The Effect of Lacosamide in Peripheral Neuropathic Pain: a Randomized, Double-blind, Placebo Controlled, Phenotype-stratified Study",TERMINATED,,PHASE2,63.0,ACTUAL,Danish Pain Research Center,,2.0,,COVID 19 and recruitment problems,f,,,,t,f,f,,,,,,,,,,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2022,0.0
NCT04309721,,2019-12-04,,,2023-12-08,2020-03-12,2020-03-16,ACTUAL,,,,,,,2023-12-08,2023-12-14,ACTUAL,2022-11-02,ACTUAL,2022-11-02,2023-12,2023-12-31,2023-11-13,ACTUAL,2023-11-13,2022-11-02,ACTUAL,2022-11-02,,INTERVENTIONAL,PEPSI,,Perampanel in Focal Status Epilepticus,Efficacy of add-on PEramPanel in Focal Motor Status Epilepticus,TERMINATED,,PHASE3,1.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,Lack of inclusion,f,,,,f,f,f,,,,,,,,,,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2023,0.0
NCT05038800,,2021-08-24,,,2023-12-26,2021-09-07,2021-09-09,ACTUAL,,,,,,,2023-12-26,2024-01-02,ACTUAL,2021-09-26,ACTUAL,2021-09-26,2023-12,2023-12-31,2023-12-11,ACTUAL,2023-12-11,2023-12-11,ACTUAL,2023-12-11,,INTERVENTIONAL,,,A Study to Evaluate MK-0482 for Relapsed/Refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) (MK-0482-002),"A Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of MK-0482 in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia",TERMINATED,,PHASE1,12.0,ACTUAL,Merck Sharp & Dohme LLC,,1.0,,Business Reasons,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 16:43:55.4698,2024-10-16 16:43:55.4698,INDUSTRY,,,,,,,2023,0.0
NCT04952571,,2021-06-23,,,2024-10-09,2021-07-02,2021-07-07,ACTUAL,,,,,,,2024-10-09,2024-10-15,ACTUAL,2021-06-27,ACTUAL,2021-06-27,2024-10,2024-10-31,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,Combined Treatment of Camrelizumab and Bevacizumab for Adult Patients with Recurrent Glioblastoma (GBM),An Exploratory Study on Camrelizumab Combined with Bevacizumab for Adult Patients with Recurrent Glioblastoma (GBM),TERMINATED,,PHASE2,3.0,ACTUAL,Beijing Sanbo Brain Hospital,,2.0,,Lack of funds,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-17 04:24:16.629849,2024-10-17 04:24:16.629849,OTHER,,,,,,,2022,0.0
NCT03614728,,2018-07-30,2023-01-06,,2023-01-06,2018-07-30,2018-08-03,ACTUAL,2023-01-06,2023-02-06,ACTUAL,,,,2023-01-06,2023-02-06,ACTUAL,2018-10-16,ACTUAL,2018-10-16,2023-01,2023-01-31,2022-01-11,ACTUAL,2022-01-11,2022-01-11,ACTUAL,2022-01-11,,INTERVENTIONAL,,All Treated Population consisted of all participants who received at least one dose of GSK3326595 as monotherapy or at least one dose of both combination drugs as combination treatment. Data was not collected in Part 2 of the study as no participant was enrolled in Part 2.,Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML),A Phase I/II Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents in Participants With Myelodysplastic Syndrome and Acute Myeloid Leukaemia,TERMINATED,,PHASE1/PHASE2,30.0,ACTUAL,GlaxoSmithKline,,3.0,,Trial terminated due to internal review of clinical data in context of indication under investigation,f,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 16:43:55.4698,2024-10-16 16:43:55.4698,INDUSTRY,,,,,,,2022,0.0
NCT03396861,,2018-01-05,,,2024-10-09,2018-01-05,2018-01-11,ACTUAL,,,,,,,2024-10-09,2024-10-15,ACTUAL,2019-02-22,ACTUAL,2019-02-22,2024-10,2024-10-31,2020-01-02,ACTUAL,2020-01-02,2019-08-18,ACTUAL,2019-08-18,,INTERVENTIONAL,ACME,,Treatment of Macular Edema After Cataract Surgery with Subconjunctival Aflibercept,Subconjunctival Aflibercept Injection for Pseudophakic Cystoid Macular Edema,TERMINATED,,PHASE1,1.0,ACTUAL,Tufts Medical Center,,1.0,,Low enrollment,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 04:24:16.629849,2024-10-17 04:24:16.629849,OTHER,,,,,,,2020,0.0
NCT04071756,,2019-06-05,2023-01-13,,2024-02-05,2019-08-26,2019-08-28,ACTUAL,2023-10-24,2023-11-15,ACTUAL,,,,2024-02-05,2024-02-07,ACTUAL,2019-12-30,ACTUAL,2019-12-30,2024-02,2024-02-29,2022-07-14,ACTUAL,2022-07-14,2021-06-12,ACTUAL,2021-06-12,,INTERVENTIONAL,,,Topical Tazarotene Vs Placebo In Hand-Foot-Skin Reactions,A Phase II Randomized Double-Blind Trial of Topical Tazarotene 0.1% Gel Versus Placebo Gel for the Prevention of Regorafenib-Induced Hand-Foot-Skin Reaction,TERMINATED,,PHASE2,8.0,ACTUAL,Dana-Farber Cancer Institute,"This study was terminated prematurely on 7/14/2022 as there had been significant difficulty with patient recruitment.~This report includes data for eight (8) randomized participants. The first enrolled on December 30, 2019, and the last on July 28, 2020.",2.0,,Difficulty with patient recruitment,f,,,,t,t,f,,,f,,,Data can be shared no earlier than 1 year following the date of publication,BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,OTHER,,,,,,,2022,0.0
NCT03742804,,2018-11-13,,,2019-12-16,2018-11-14,2018-11-15,ACTUAL,,,,,,,2019-12-16,2019-12-18,ACTUAL,2019-06,ESTIMATED,2019-06-30,2019-12,2019-12-31,2022-12,ESTIMATED,2022-12-31,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,Study Of Intratumoral G100 In Cutaneous T Cell Lymphoma,Pilot Phase 2 Study of Intratumoral G100 in Patients With Cutaneous T Cell Lymphoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,Yale University,,1.0,,Study sponsor sold and the new company would not support the study.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2022,0.0
NCT02553915,,2015-09-16,2019-08-23,,2022-04-04,2015-09-16,2015-09-18,ESTIMATED,2019-10-27,2019-11-18,ACTUAL,,,,2022-04-04,2022-05-02,ACTUAL,2015-12,ACTUAL,2015-12-31,2022-04,2022-04-30,2022-03-31,ACTUAL,2022-03-31,2018-07-13,ACTUAL,2018-07-13,,INTERVENTIONAL,,"Adults with major depressive disorder, overweight, with elevated hsCRP at baseline.",Omega-3 Fatty Acids for Major Depressive Disorder With High Inflammation: A Personalized Approach,Omega-3 Fatty Acids for MDD With High Inflammation: A Personalized Approach,COMPLETED,,PHASE2/PHASE3,61.0,ACTUAL,Massachusetts General Hospital,Smaller than projected sample due to challenges in recruitment led to smaller analyzable treatment arms. Results should be considered preliminary.,4.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2022,1.0
NCT05155085,,2021-12-01,2024-09-03,,2024-09-24,2021-12-01,2021-12-13,ACTUAL,2024-09-03,2024-09-24,ACTUAL,,,,2024-09-24,2024-10-15,ACTUAL,2022-06-27,ACTUAL,2022-06-27,2024-09,2024-09-30,2024-04-17,ACTUAL,2024-04-17,2023-12-18,ACTUAL,2023-12-18,,INTERVENTIONAL,ATLAS,Baseline analysis is reported on the safety population of the main study period. Baseline information of OLE subjects is not reported since it is already captured as part of the main study population.,A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Lirentelimab in Adult Subjects With Moderate-to-Severe Atopic Dermatitis Inadequately Controlled by Topical Treatments",TERMINATED,,PHASE2,131.0,ACTUAL,Allakos Inc.,,2.0,,No longer pursuing development,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 04:24:16.629849,2024-10-17 04:24:16.629849,INDUSTRY,,,,,,,2024,0.0
NCT04649060,,2020-11-24,2023-02-07,,2023-05-12,2020-11-24,2020-12-02,ACTUAL,2023-05-12,2023-06-08,ACTUAL,,,,2023-05-12,2023-06-08,ACTUAL,2020-12-21,ACTUAL,2020-12-21,2023-02,2023-02-28,2022-02-07,ACTUAL,2022-02-07,2022-02-07,ACTUAL,2022-02-07,,INTERVENTIONAL,LIGHTHOUSE,,Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma,"A Randomized, Controlled, Open-Label Phase 3 Study of Melflufen in Combination With Daratumumab Compared With Daratumumab in Patients With Relapsed or Relapsed-Refractory Multiple Myeloma",TERMINATED,,PHASE3,54.0,ACTUAL,Oncopeptides AB,"This study was put on clinical hold and later discontinued prematurely. Due to this, there is limited data available, and data cleaning was not done according to the original plan. Due to the early termination, the response assessments were done by investigators, not by an independent review committee.",2.0,,The sponsor decided to terminate the study due to financial issues following an FDA request for a partial clinical hold.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,INDUSTRY,,,,,,,2022,0.0
NCT02790528,,2016-05-26,,,2017-06-14,2016-05-31,2016-06-06,ESTIMATED,,,,,,,2017-06-14,2017-06-15,ACTUAL,2017-07,ESTIMATED,2017-07-31,2017-06,2017-06-30,2023-12,ESTIMATED,2023-12-31,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,STAVA,,Statin Therapy In Patients With Vasospastic Angina,"A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of Statin Therapy In Patients With Vasospastic Angina",WITHDRAWN,,PHASE4,0.0,ACTUAL,Asan Medical Center,,2.0,,Funding issue,f,,,,t,f,f,,,,,,,,,NO,This is not a publicly funded trial.,2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,OTHER,,,,,,,2023,0.0
NCT04015336,,2019-07-06,2021-12-08,,2022-02-03,2019-07-10,2019-07-11,ACTUAL,2022-01-03,2022-02-01,ACTUAL,,,,2022-02-03,2022-02-24,ACTUAL,2020-07-06,ACTUAL,2020-07-06,2022-02,2022-02-28,2020-07-15,ACTUAL,2020-07-15,2020-07-15,ACTUAL,2020-07-15,,INTERVENTIONAL,,,E7 TCR Cell Induction Immunotherapy for Stage II and Stage III HPV-Associated Oropharyngeal Cancer,A Phase II Study of E7 TCR T Cell Induction Immunotherapy for Stage II and Stage III HPV-Associated Oropharyngeal Cancer,TERMINATED,,PHASE2,1.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,Logistical challenges,f,,,,f,t,f,,,,,,Before publication and at the time of publication or shortly thereafter.,"Clinical Trials.gov, Biomedical Translational Research Information System (BTRIS), approved outside collaborators under appropriate individual agreements, and publication and/or public presentations.",,YES,"Data will be shared as follows: Coded, linked data in an National Institutes of Health (NIH)-funded or approved public repository, coded, linked data in Biomedical Translational Research Information System (BTRIS), and identified or coded, linked data with approved outside collaborators under appropriate agreements.",2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,NIH,,,,,,,2020,0.0
NCT03198234,,2017-04-11,2024-06-18,,2024-07-16,2017-06-21,2017-06-26,ACTUAL,2024-07-16,2024-07-18,ACTUAL,,,,2024-07-16,2024-07-18,ACTUAL,2017-08-30,ACTUAL,2017-08-30,2024-07,2024-07-31,2021-11-11,ACTUAL,2021-11-11,2021-11-11,ACTUAL,2021-11-11,,INTERVENTIONAL,T-allo10,"Cohort 1 was completed, and Cohort 2 enrolled two participants before closing due to feasibility.",Use of T-allo10 in Hematopoietic Stem Cell Transplantation (HSCT) for Blood Disorders,Use of T-allo10 Cell Infusions Combined With Mismatched Related or Mismatched Unrelated Hematopoietic Stem Cell Transplantation (HSCT) for Hematologic Malignancies,TERMINATED,,PHASE1,5.0,ACTUAL,Stanford University,Early termination led to a small number of participants analyzed.,3.0,,Lack of Enrollment,f,,,,t,t,f,,,,,,,,,NO,There is no plan to share the individual participant data.,2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,OTHER,,,,,,,2021,0.0
NCT05144360,,2021-11-22,,,2023-09-05,2021-11-22,2021-12-03,ACTUAL,,,,,,,2023-09-05,2023-09-08,ACTUAL,2022-08,ESTIMATED,2022-08-31,2023-09,2023-09-30,2024-11,ESTIMATED,2024-11-30,2024-07,ESTIMATED,2024-07-31,,INTERVENTIONAL,ATENAS,,Efficacy and Safety of Atenas Association in the Treatment of Type II Diabetes Mellitus and Hypertension,"National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Atenas Association in the Treatment of Type II Diabetes Mellitus and Hypertension",WITHDRAWN,,PHASE3,0.0,ACTUAL,EMS,,2.0,,Strategy review,f,,,,t,f,f,,,,,,,,,,,2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,INDUSTRY,,,,,,,2024,0.0
NCT03922750,,2019-04-17,2020-12-11,,2022-01-06,2019-04-17,2019-04-22,ACTUAL,2020-12-11,2021-01-08,ACTUAL,,,,2022-01-06,2022-01-18,ACTUAL,2019-05-09,ACTUAL,2019-05-09,2022-01,2022-01-31,2020-01-27,ACTUAL,2020-01-27,2019-12-19,ACTUAL,2019-12-19,,INTERVENTIONAL,,The full analysis set included all randomised participants.,A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine,"A Trial Comparing NNC0148-0287 C (Insulin 287) Versus Insulin Glargine U100, Both in Combination With Metformin, With or Without DPP4 Inhibitors and With or Without SGLT2 Inhibitors, in Basal Insulin Treated Subjects With Type 2 Diabetes Mellitus",COMPLETED,,PHASE2,154.0,ACTUAL,Novo Nordisk A/S,,3.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 16:43:55.4698,2024-10-16 16:43:55.4698,INDUSTRY,,,,,,,2020,1.0
NCT03957096,,2019-05-17,,,2020-09-15,2019-05-17,2019-05-21,ACTUAL,,,,,,,2020-09-15,2020-09-17,ACTUAL,2019-07-17,ACTUAL,2019-07-17,2020-09,2020-09-30,2020-09-14,ACTUAL,2020-09-14,2020-09-14,ACTUAL,2020-09-14,,INTERVENTIONAL,,,A Safety Study of SGN-CD47M in Patients With Solid Tumors,A Phase 1 Study of SGN-CD47M in Patients With Advanced Solid Tumors,TERMINATED,,PHASE1,16.0,ACTUAL,Seagen Inc.,,1.0,,Sponsor decision based on portfolio prioritization,f,,,,f,t,f,,,,,,,,,,,2024-10-16 16:43:55.4698,2024-10-16 16:43:55.4698,INDUSTRY,,,,,,,2020,0.0
NCT04250805,,2020-01-30,,,2024-01-30,2020-01-30,2020-01-31,ACTUAL,,,,,,,2024-01-30,2024-01-31,ACTUAL,2020-10-27,ACTUAL,2020-10-27,2024-01,2024-01-31,2024-01-23,ACTUAL,2024-01-23,2024-01-23,ACTUAL,2024-01-23,,INTERVENTIONAL,GASTROXY,,Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy,Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy,TERMINATED,,PHASE2,17.0,ACTUAL,Centre Hospitalier Universitaire de Saint Etienne,,2.0,,Difficulties in recruiting patients,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2024,0.0
NCT04160195,,2019-11-08,2021-12-16,,2022-01-26,2019-11-08,2019-11-12,ACTUAL,2022-01-26,2022-02-15,ACTUAL,,,,2022-01-26,2022-02-15,ACTUAL,2019-12-20,ACTUAL,2019-12-20,2022-01,2022-01-31,2021-06-11,ACTUAL,2021-06-11,2021-06-11,ACTUAL,2021-06-11,,INTERVENTIONAL,,No participants were enrolled on group 2 because the study was stopped. The chimeric antigen receptor (CAR) gene used in this study is prone to recombination events and is therefore not stable.,T Cells Expressing Fully-human Anti-CD19 and Anti-CD20 Chimeric Antigen Receptors for Treating B-cell Malignancies and Hodgkin Lymphoma,T Cells Expressing Fully-human Anti-CD19 and Anti-CD20 Chimeric Antigen Receptors for Treating B-cell Malignancies and Hodgkin Lymphoma,TERMINATED,,PHASE1,2.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,The original principal investigator left the National Institutes of Health (NCI) and the decision was made to close the study to enrollment.,f,,,,f,t,f,,,,,,Data will be shared before publication and at the time of publication or shortly thereafter indefinitely.,"Data will be shared through ClinicalTrials.gov, BTRIS, approved outside collaborators under appropriate individual agreements, and publication and/or public presentations.",,YES,"Human data will be shared as follows: Coded, linked data in a National Institutes of Health-funded or approved repository. Coded, linked data in the Biomedical Translational Research Information System (BTRIS). And coded, linked or identified data with approved outside collaborators under appropriate agreements.",2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,NIH,,,,,,,2021,0.0
NCT04404361,,2020-05-22,2024-02-09,,2024-05-07,2020-05-22,2020-05-27,ACTUAL,2024-05-07,2024-06-05,ACTUAL,,,,2024-05-07,2024-06-05,ACTUAL,2020-05-22,ACTUAL,2020-05-22,2024-05,2024-05-31,2021-09-21,ACTUAL,2021-09-21,2021-09-21,ACTUAL,2021-09-21,,INTERVENTIONAL,,,PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer,"A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study of Pacritinib Plus Standard of Care Versus Placebo and Standard of Care in Hospitalized Patients With Severe COVID-19 With or Without Cancer",TERMINATED,,PHASE2,200.0,ACTUAL,CTI BioPharma,,2.0,,decision to close enrollment early,f,,,,,t,f,,,,,,,,,,,2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,INDUSTRY,,,,,,,2021,0.0
NCT03694522,,2018-09-14,2022-04-28,,2024-02-23,2018-10-01,2018-10-03,ACTUAL,2022-04-28,2022-05-24,ACTUAL,,,,2024-02-23,2024-02-28,ACTUAL,2018-09-14,ACTUAL,2018-09-14,2024-02,2024-02-29,2022-05-13,ACTUAL,2022-05-13,2020-09-23,ACTUAL,2020-09-23,,INTERVENTIONAL,FIGHT,The intent-to-treat (ITT) population includes all participants who were randomized in the study.,A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer,"FIGHT: A Phase 2 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Preceded by Dose-Finding in Phase 1",COMPLETED,,PHASE2,155.0,ACTUAL,"Five Prime Therapeutics, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,INDUSTRY,,,,,,,2022,1.0
NCT01828112,,2013-04-02,2017-06-24,,2023-11-27,2013-04-09,2013-04-10,ESTIMATED,2017-06-27,2017-07-27,ACTUAL,,,,2023-11-27,2023-11-30,ACTUAL,2013-06-28,ACTUAL,2013-06-28,2023-11,2023-11-30,2023-11-10,ACTUAL,2023-11-10,2016-01-26,ACTUAL,2016-01-26,,INTERVENTIONAL,,The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.,LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib,"A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib",COMPLETED,,PHASE3,231.0,ACTUAL,Novartis,"Although 116 patients were randomized to the Chemotherapy arm, 3 did not receive study drug and were excluded form the Safety set.",2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 16:43:55.4698,2024-10-16 16:43:55.4698,INDUSTRY,,,,,,,2023,1.0
NCT05169931,,2021-12-14,,,2022-11-07,2021-12-14,2021-12-27,ACTUAL,,,,,,,2022-11-07,2022-11-10,ACTUAL,2022-01,ESTIMATED,2022-01-31,2022-11,2022-11-30,2022-05,ESTIMATED,2022-05-31,2022-04,ESTIMATED,2022-04-30,,INTERVENTIONAL,,,Clinical Efficacy of Amniotic Membrane Extract Eye Drops in Dry Eye Treatment,Clinical Efficacy of Amniotic Membrane Extract Eye Drops in Dry Eye Treatment,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,"University of California, Los Angeles",,1.0,,Lack of funding/support,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 16:43:55.4698,2024-10-16 16:43:55.4698,OTHER,,,,,,,2022,0.0
NCT02399462,,2015-01-08,,,2021-08-26,2015-03-20,2015-03-26,ESTIMATED,,,,,,,2021-08-26,2021-08-30,ACTUAL,2021-03,ESTIMATED,2021-03-31,2021-08,2021-08-31,2021-07-31,ACTUAL,2021-07-31,2021-07-31,ACTUAL,2021-07-31,,INTERVENTIONAL,,,Acthar for Treatment of Post-transplant FSGS,Acthar for Treatment of Post-transplant FSGS,WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of North Carolina, Chapel Hill",,1.0,,Funding terminated prematurely,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 16:43:55.4698,2024-10-16 16:43:55.4698,OTHER,,,,,,,2021,0.0
NCT03208244,,2017-07-03,2022-05-10,,2022-06-01,2017-07-03,2017-07-05,ACTUAL,2022-05-10,2022-06-02,ACTUAL,,,,2022-06-01,2022-06-22,ACTUAL,2017-11-09,ACTUAL,2017-11-09,2022-06,2022-06-30,2021-04-28,ACTUAL,2021-04-28,2021-04-20,ACTUAL,2021-04-20,,INTERVENTIONAL,,Number of subjects initiating treatment with DAA,DAA Treatment in Donor HCV-positive to Recipient HCV-negative Heart Transplant,Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Heart Transplant,TERMINATED,,PHASE4,40.0,ACTUAL,Massachusetts General Hospital,"Protocol was terminated prior to completion, primarily due to lack of resources (research staffing and funding) and clinical team moving HCV+ donor to HCV- recipient transplants to standard of care.",1.0,,"Protocol transitioned to standard of care, no funding available to support research work",f,,,,f,t,f,,,f,,,Anticipate data would be available to share within 6 months after the final patient completes the study.,Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.,,YES,Anticipate to share coded data with collaborators,2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,OTHER,,,,,,,2021,0.0
NCT06082843,,2023-10-09,,,2024-10-15,2023-10-09,2023-10-13,ACTUAL,,,,,,,2024-10-15,2024-10-16,ESTIMATED,2024-01-03,ACTUAL,2024-01-03,2024-10,2024-10-31,2024-05-30,ACTUAL,2024-05-30,2024-05-30,ACTUAL,2024-05-30,,INTERVENTIONAL,,,A Study to Test Whether Avenciguat Helps People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver) Who Had Bleeding in the Esophagus or Fluid Accumulation in the Belly,"Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Investigate the Effects of One Dose (Up-titration to a Fixed Dose Regimen) of Oral BI 685509 on Portal Hypertension After 8 Weeks Treatment in Patients With Clinically Significant Portal Hypertension (CSPH) in Decompensated Cirrhosis After Their First Decompensation Event, Who Are Stabilized CTP 5-7",TERMINATED,,PHASE2,22.0,ACTUAL,Boehringer Ingelheim,,2.0,,Company decision,f,,,,t,t,f,,,,,,"After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents upon signing of a 'Document Sharing Agreement'.For study data 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.",https://www.mystudywindow.com/msw/datasharing,YES,"Once the criteria in section 'time frame frame' are fulfilled , researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.",2024-10-17 04:24:16.629849,2024-10-17 04:24:16.629849,INDUSTRY,,,,,,,2024,0.0
NCT05878704,,2023-05-19,,,2024-10-11,2023-05-19,2023-05-26,ACTUAL,,,,,,,2024-10-11,2024-10-15,ACTUAL,2023-06-29,ACTUAL,2023-06-29,2024-10,2024-10-31,2024-07-29,ACTUAL,2024-07-29,2024-07-29,ACTUAL,2024-07-29,,INTERVENTIONAL,,,Study of GBT021601 in Participants With Renal Impairment,"A Phase I, Open-Label, Single-Dose, Non-Randomized, Parallel Group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of GBT021601, an Oral Hemoglobin S Polymerization Inhibitor, in Adult Participants With Renal Impairment",TERMINATED,,PHASE1,8.0,ACTUAL,Pfizer,,1.0,,Business decision to terminate the trial after the completion of Part 1: Cohort 1 (severe renal impairment). The decision to terminate the trial was not due to any potential safety concerns.,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 04:24:16.629849,2024-10-17 04:24:16.629849,INDUSTRY,,,,,,,2024,0.0
NCT03129100,,2017-04-03,2021-05-24,,2022-05-12,2017-04-21,2017-04-26,ACTUAL,2021-05-24,2021-06-18,ACTUAL,,,,2022-05-12,2022-06-13,ACTUAL,2017-05-09,ACTUAL,2017-05-09,2022-05,2022-05-31,2021-05-27,ACTUAL,2021-05-27,2020-05-26,ACTUAL,2020-05-26,,INTERVENTIONAL,,All randomized participants from extension period (period 2).,A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis,"A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients With Axial Spondyloarthritis",COMPLETED,,PHASE3,773.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,INDUSTRY,,,,,,,2021,1.0
NCT04643691,,2020-11-24,,,2024-06-21,2020-11-24,2020-11-25,ACTUAL,,,,,,,2024-06-21,2024-06-24,ACTUAL,2020-09-11,ACTUAL,2020-09-11,2024-06,2024-06-30,2021-12-07,ACTUAL,2021-12-07,2021-12-07,ACTUAL,2021-12-07,,INTERVENTIONAL,COVIDANCE,,Losartan and Spironolactone Treatment for ICU Patients With COVID-19 Suffering From ARDS,Benefit of Treatment With Losartan and Spironolactone on the Regulation of the Renin-angiotensin System in the Prognosis of Patients Infected With COVID-19 and Suffering From Acute Respiratory Distress Syndrome,TERMINATED,,PHASE2,78.0,ACTUAL,Assistance Publique Hopitaux De Marseille,,2.0,,due to an Urgent Security Measure,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 16:43:55.4698,2024-10-16 16:43:55.4698,OTHER,,,,,,,2021,0.0
NCT05041101,,2021-09-02,,,2024-10-08,2021-09-02,2021-09-10,ACTUAL,,,,,,,2024-10-08,2024-10-15,ACTUAL,2021-11-04,ACTUAL,2021-11-04,2024-10,2024-10-31,2024-09-06,ACTUAL,2024-09-06,2024-09-06,ACTUAL,2024-09-06,,INTERVENTIONAL,,,Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer,Phase Ib/II Study of Grapiprant (IK-007) and Eribulin Combination Treatment for Metastatic Inflammatory Breast Cancer (mIBC),TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,The sponsor terminated support for this study,,,,,t,t,f,,,,,,,,,,,2024-10-17 04:24:16.629849,2024-10-17 04:24:16.629849,OTHER,,,,,,,2024,0.0
NCT04774328,,2021-02-24,2022-06-10,,2022-08-19,2021-02-24,2021-03-01,ACTUAL,2022-08-19,2022-09-14,ACTUAL,,,,2022-08-19,2022-09-14,ACTUAL,2020-09-09,ACTUAL,2020-09-09,2022-08,2022-08-31,2021-06-15,ACTUAL,2021-06-15,2021-06-15,ACTUAL,2021-06-15,,INTERVENTIONAL,,,Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair,"A Three-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics, and Preliminary Efficacy Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair",COMPLETED,,PHASE1/PHASE2,34.0,ACTUAL,Concentric Analgesics,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,INDUSTRY,,,,,,,2021,1.0
NCT03608501,,2018-07-11,,,2020-01-10,2018-07-23,2018-08-01,ACTUAL,,,,,,,2020-01-10,2020-01-14,ACTUAL,2019-09-30,ESTIMATED,2019-09-30,2020-01,2020-01-31,2023-05-31,ESTIMATED,2023-05-31,2021-06-30,ESTIMATED,2021-06-30,,INTERVENTIONAL,IDEALL,,"A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation","An Open-Label, Single-Arm Phase II Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-Naive Multiple Myeloma Patients Non-Eligible for Autologous Stem-Cell Transplantation",WITHDRAWN,,PHASE2,0.0,ACTUAL,Takeda,,1.0,,Business decision (no safety or efficacy concerns),f,,,,t,f,f,,,,,,,,,YES,"Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,INDUSTRY,,,,,,,2023,0.0
NCT04249583,,2019-12-30,2023-05-23,2021-05-26,2023-05-23,2020-01-29,2020-01-31,ACTUAL,2023-05-23,2023-06-18,ACTUAL,2021-05-26,2021-05-28,ACTUAL,2023-05-23,2023-06-18,ACTUAL,2020-02-10,ACTUAL,2020-02-10,2022-09,2022-09-30,2021-01-05,ACTUAL,2021-01-05,2020-08-07,ACTUAL,2020-08-07,,INTERVENTIONAL,READY-1,,Treatment of Moderate to Severe Glabellar Lines,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Glabellar Lines",COMPLETED,,PHASE3,300.0,ACTUAL,Galderma R&D,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,INDUSTRY,,,,,,,2021,1.0
NCT04244058,,2020-01-23,,,2022-09-27,2020-01-27,2020-01-28,ACTUAL,,,,,,,2022-09-27,2022-09-30,ACTUAL,2020-09-23,ACTUAL,2020-09-23,2022-09,2022-09-30,2023-06-30,ESTIMATED,2023-06-30,2023-05-30,ESTIMATED,2023-05-30,,INTERVENTIONAL,,,Changes in Glutamatergic Neurotransmission of Severe TBI Patients,Evaluation of Pharmacologically-induced Changes in Excitatory Glutamatergic Neurotransmission of Severe TBI Patients,SUSPENDED,,EARLY_PHASE1,30.0,ESTIMATED,Weill Medical College of Cornell University,,2.0,,Given CoVid-19 pandemic we could not recruit subjects/patients for the 1st year. Currently waiting for new sponsor to fulfill the aims.,f,,,,t,t,f,,,,,,Data will be available from publication date up to 3 years.,Only under a data-sharing agreement.,,YES,"The proposed research will involve a small sample with deficits secondary to traumatic brain injury (i.e., vegetative state and minimally conscious state). These rare disorders are associated with distinguishing features that even with the removal of all identifiers it would be difficult if not impossible to protect the identities of subjects. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.~Data to be share will be 18F-FPEB raw data; CRS-R available data; anatomical data from the MRI.",2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,OTHER,,,,,,,2023,0.0
NCT02207244,,2014-07-31,2017-08-04,2016-07-12,2021-06-29,2014-07-31,2014-08-04,ESTIMATED,2017-09-28,2017-11-06,ACTUAL,2016-07-12,2016-07-14,ESTIMATED,2021-06-29,2021-07-22,ACTUAL,2014-11-03,ACTUAL,2014-11-03,2021-06,2021-06-30,2020-07-01,ACTUAL,2020-07-01,2015-10-01,ACTUAL,2015-10-01,,INTERVENTIONAL,VOYAGE 2,,A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment,"A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis With Randomized Withdrawal and Retreatment",COMPLETED,,PHASE3,992.0,ACTUAL,"Janssen Research & Development, LLC","All participants were on guselkumab after Week 76; therefore, there was no concurrent control group within the study after Week 76.",3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,INDUSTRY,,,,,,,2020,1.0
NCT02479178,,2015-06-19,,,2016-04-13,2015-06-23,2015-06-24,ESTIMATED,,,,,,,2016-04-13,2016-04-14,ESTIMATED,2015-06,,2015-06-30,2016-04,2016-04-30,2020-01,ESTIMATED,2020-01-31,2016-10,ESTIMATED,2016-10-31,,INTERVENTIONAL,iNSITE2,,"A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck","A Phase 2 Study to Determine the Efficacy and Safety of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck",TERMINATED,,PHASE2,73.0,ACTUAL,BIND Therapeutics,,,,,f,,,,,,,,,,,,,,,,,2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,INDUSTRY,,,,,,,2020,0.0
NCT03546556,,2018-03-19,,,2023-02-09,2018-06-01,2018-06-06,ACTUAL,,,,,,,2023-02-09,2023-02-13,ACTUAL,2017-01-01,ACTUAL,2017-01-01,2023-02,2023-02-28,2020-03-12,ACTUAL,2020-03-12,2020-03-12,ACTUAL,2020-03-12,,INTERVENTIONAL,,,18-FLT PET/MR Imaging to Predict Graft Failure and GVHD in Bone Marrow Transplant Patients,18-FLT PET/MR Imaging to Predict Graft Failure and Graft Versus Host Disease in Bone Marrow Transplant Patients,TERMINATED,,EARLY_PHASE1,10.0,ACTUAL,UNC Lineberger Comprehensive Cancer Center,,2.0,,Study terminated due to COVID-19 pandemic and not being able to perform PET/MR scans on participants.,,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 06:49:49.286187,2024-10-16 06:49:49.286187,OTHER,,,,,,,2020,0.0
NCT00023504,,2001-09-07,,,2021-10-14,2001-09-07,2001-09-10,ESTIMATED,,,,,,,2021-10-14,2021-10-15,ACTUAL,2002-06-13,ACTUAL,2002-06-13,2021-10,2021-10-31,2021-10-14,ACTUAL,2021-10-14,2017-05-22,ACTUAL,2017-05-22,,INTERVENTIONAL,,,Antibody Production in Immune Disorders,Evaluation of Immune Response to Vaccines in Primary Immune Disorders,TERMINATED,,PHASE4,21.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,Slow/Insufficient accrual,f,,,,,t,f,,,,,,,,,,,2024-10-15 09:27:30.194574,2024-10-15 09:27:30.194574,NIH,,,,,,,2021,0.0
NCT04965272,,2021-07-07,,,2022-04-07,2021-07-07,2021-07-16,ACTUAL,,,,,,,2022-04-07,2022-04-12,ACTUAL,2021-08-18,ESTIMATED,2021-08-18,2022-04,2022-04-30,2021-08-24,ACTUAL,2021-08-24,2021-08-24,ACTUAL,2021-08-24,,INTERVENTIONAL,CAR aGAD Ph 2,,A Study To Assess Adverse Events and Change in Disease Activity With Oral Cariprazine When Added to Antidepressant Therapies (ADTs) Compared to Placebo in Adult Participants With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response to ADTs Alone,"A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Fixed-Dose, Phase 2 Study Evaluating the Safety and Efficacy of Cariprazine as an Adjunctive Therapy to Antidepressant Therapies (ADTs), in the Treatment of Subjects With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response to ADT Alone",WITHDRAWN,,PHASE2,0.0,ACTUAL,AbbVie,,4.0,,Strategic Decision,f,,,,f,t,f,,,t,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,INDUSTRY,,,,,,,2021,0.0
NCT03473977,,2018-02-28,2021-06-21,,2022-01-27,2018-03-15,2018-03-22,ACTUAL,2021-07-26,2021-08-17,ACTUAL,,,,2022-01-27,2022-02-03,ACTUAL,2018-04-23,ACTUAL,2018-04-23,2022-01,2022-01-31,2022-01-12,ACTUAL,2022-01-12,2020-06-22,ACTUAL,2020-06-22,,INTERVENTIONAL,BEGS,,Benralizumab for Eosinophilic Gastritis (BEGS),"A Randomized, Double-Blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of Benralizumab (Anti-IL5RA) in Subjects With Eosinophilic Gastritis",COMPLETED,,PHASE2/PHASE3,26.0,ACTUAL,"Children's Hospital Medical Center, Cincinnati",,2.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,OTHER,,,,,,,2022,1.0
NCT04103814,,2019-09-23,2024-06-26,,2024-09-25,2019-09-24,2019-09-25,ACTUAL,2024-09-25,2024-10-15,ACTUAL,,,,2024-09-25,2024-10-15,ACTUAL,2019-10-20,ACTUAL,2019-10-20,2024-09,2024-09-30,2023-05-15,ACTUAL,2023-05-15,2023-05-15,ACTUAL,2023-05-15,,INTERVENTIONAL,,study terminated as it was too resource intensive to obtain pain scores from patients,Effect of Topical CBD Cream for Degenerative Hallux Disorders,Effect of Topical CBD Oil on Pain Scores for Hallux Disorders: A Randomized Controlled Trial,TERMINATED,,PHASE2/PHASE3,11.0,ACTUAL,Rush University Medical Center,,2.0,,Lack of resources to continue enrollment,f,,,,,t,f,,,t,,,,,,NO,,2024-10-17 04:24:16.629849,2024-10-17 04:24:16.629849,OTHER,,,,,,,2023,0.0
NCT03978520,,2019-06-03,2023-06-27,2022-12-19,2023-06-27,2019-06-05,2019-06-07,ACTUAL,2023-06-27,2023-07-21,ACTUAL,2022-12-19,2022-12-23,ACTUAL,2023-06-27,2023-07-21,ACTUAL,2019-07-25,ACTUAL,2019-07-25,2023-06,2023-06-30,2022-07-14,ACTUAL,2022-07-14,2022-01-19,ACTUAL,2022-01-19,,INTERVENTIONAL,SLEek,Full Analysis Set: all randomized participants who received at least 1 dose of study drug,A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE),A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus,COMPLETED,,PHASE2,341.0,ACTUAL,AbbVie,,5.0,,,f,,,,t,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,INDUSTRY,,,,,,,2022,1.0
NCT03545165,,2018-05-04,2021-03-26,,2021-07-29,2018-05-31,2018-06-04,ACTUAL,2021-07-29,2021-08-24,ACTUAL,,,,2021-07-29,2021-08-24,ACTUAL,2018-04-18,ACTUAL,2018-04-18,2021-07,2021-07-31,2020-07-15,ACTUAL,2020-07-15,2020-07-15,ACTUAL,2020-07-15,,INTERVENTIONAL,,,177Lu-J591 and 177Lu-PSMA-617 Combination for mCRPC,Phase I/II Dose-Escalation Trial of Combination Fractionated-dose 177Lu-J591 and 177Lu-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer,TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,Weill Medical College of Cornell University,The study was terminated early due to sponsor withdrawal (PSMA-617 no longer available for purchase).,1.0,,Sponsor withdrawal,f,,,,t,t,f,,,,,,,,,,,2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,OTHER,,,,,,,2020,0.0
NCT02622321,,2015-12-02,2017-10-19,,2021-05-26,2015-12-02,2015-12-04,ESTIMATED,2017-11-21,2017-11-24,ACTUAL,,,,2021-05-26,2021-06-24,ACTUAL,2015-11-18,ACTUAL,2015-11-18,2021-05,2021-05-31,2020-12-01,ACTUAL,2020-12-01,2016-10-25,ACTUAL,2016-10-25,,INTERVENTIONAL,HAVEN 1,All enrolled participants,"A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors","A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients With Inhibitors",COMPLETED,,PHASE3,113.0,ACTUAL,Hoffmann-La Roche,,4.0,,,t,,,,t,t,f,,,,,,,,,,,2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,INDUSTRY,,NCT03154437,APPROVED_FOR_MARKETING,,,,2020,1.0
NCT05592223,,2022-10-13,,,2024-01-03,2022-10-19,2022-10-24,ACTUAL,,,,,,,2024-01-03,2024-01-05,ACTUAL,2022-12-06,ACTUAL,2022-12-06,2024-01,2024-01-31,2023-12-01,ACTUAL,2023-12-01,2023-08-23,ACTUAL,2023-08-23,,INTERVENTIONAL,,,Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines,A Phase I Single Site Open Label Clinical Trial for the Development of a Human BCG Challenge Model to Assess TB Drugs and Vaccines.,COMPLETED,,PHASE1,20.0,ACTUAL,Fred Hutchinson Cancer Center,,3.0,,,f,,,,f,t,f,,,f,,,During the participants active study period.,,,YES,Sharing de-identified AE's/SAE's from all individual participants with Merck \& Co during the trial.,2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,OTHER,,,,,,,2023,0.0
NCT03596125,,2018-05-28,,,2022-12-15,2018-07-19,2018-07-23,ACTUAL,,,,,,,2022-12-15,2022-12-19,ACTUAL,2018-11-05,ACTUAL,2018-11-05,2022-12,2022-12-31,2021-11-11,ACTUAL,2021-11-11,2021-11-11,ACTUAL,2021-11-11,,INTERVENTIONAL,,,Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth (GSH MAP),Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth,TERMINATED,,PHASE2/PHASE3,39.0,ACTUAL,Nantes University Hospital,,2.0,,difficulty of recruitment,f,,,,f,f,f,,,,,,,,,,,2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,OTHER,,,,,,,2021,0.0
NCT04502706,,2020-07-16,,,2023-06-01,2020-08-04,2020-08-06,ACTUAL,,,,,,,2023-06-01,2023-06-05,ACTUAL,2020-11-17,ACTUAL,2020-11-17,2022-05,2022-05-31,2022-03-31,ACTUAL,2022-03-31,2022-03-31,ACTUAL,2022-03-31,,INTERVENTIONAL,,,Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma,A Phase 1 Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma,TERMINATED,,PHASE1,9.0,ACTUAL,Gilead Sciences,,5.0,,Sponsor's decision to discontinue development of this molecule,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 16:43:55.4698,2024-10-16 16:43:55.4698,INDUSTRY,,,,,,,2022,0.0
NCT04702789,,2021-01-07,,,2023-12-05,2021-01-07,2021-01-11,ACTUAL,,,,,,,2023-12-05,2023-12-12,ACTUAL,2021-10-19,ACTUAL,2021-10-19,2023-12,2023-12-31,2023-11-23,ACTUAL,2023-11-23,2023-11-23,ACTUAL,2023-11-23,,INTERVENTIONAL,PRO-122,,Comparative Study of the Efficacy of Either Krytantek Ofteno PF® or Eliptic Ofteno PF® Plus Gaap Ofteno PF® for POAG or Ocular Hypertension.,"Phase IV Clinical Study to Compare the Efficacy of the Krytantek Ofteno PF® Plus Gaap Ofteno PF® Combination to the Krytantek Ofteno PF® Plus Gaap Ofteno PF® Combination, in Primary Open Angle Glaucoma or Ocular Hypertension Patients.",TERMINATED,,PHASE4,28.0,ACTUAL,Laboratorios Sophia S.A de C.V.,,2.0,,For interests of sponsor.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 16:43:55.4698,2024-10-16 16:43:55.4698,INDUSTRY,,,,,,,2023,0.0
NCT01345539,,2011-02-17,2023-06-30,2023-05-02,2023-09-21,2011-04-28,2011-05-02,ESTIMATED,2023-09-21,2023-10-11,ACTUAL,,2023-05-18,ACTUAL,2023-09-21,2023-10-11,ACTUAL,2013-06-07,ACTUAL,2013-06-07,2023-09,2023-09-30,2022-10-20,ACTUAL,2022-10-20,2022-05-03,ACTUAL,2022-05-03,,INTERVENTIONAL,,All patients enrolled in the study.,Radiosurgery for Patients With Oligometastatic Disease at Initial Presentation,Phase II Study for Curative Intent Treatment for Patients With Oligometastatic Disease at Initial Presentation,TERMINATED,,PHASE2,24.0,ACTUAL,University of Pittsburgh,,1.0,,Participant enrollment was negatively impacted by medical oncology treatment with systemic therapy alone and accrual to other clinical trials.,f,,,,t,f,t,,,f,,,,,,NO,,2024-10-16 16:43:55.4698,2024-10-16 16:43:55.4698,OTHER,,,,,,,2022,0.0
NCT03964415,,2019-05-24,2024-07-04,,2024-07-04,2019-05-24,2019-05-28,ACTUAL,2024-07-04,2024-07-31,ACTUAL,,,,2024-07-04,2024-07-31,ACTUAL,2019-10-31,ACTUAL,2019-10-31,2024-06,2024-06-30,2023-08-10,ACTUAL,2023-08-10,2023-08-10,ACTUAL,2023-08-10,,INTERVENTIONAL,MOSAICO,The full analysis set (FAS) set included all randomized participants who received at least one vaccine administration.,"A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals","A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of a Heterologous Vaccine Regimen of Ad26.Mos4.HIV and Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals",COMPLETED,,PHASE3,3900.0,ACTUAL,Janssen Vaccines & Prevention B.V.,,2.0,,,f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,INDUSTRY,,,,,,,2023,0.0
NCT04770155,,2021-02-16,2023-09-11,,2023-10-06,2021-02-22,2021-02-25,ACTUAL,2023-10-06,2023-10-31,ACTUAL,,,,2023-10-06,2023-10-31,ACTUAL,2021-05-27,ACTUAL,2021-05-27,2023-10,2023-10-31,2021-09-20,ACTUAL,2021-09-20,2021-09-20,ACTUAL,2021-09-20,,INTERVENTIONAL,UMMC_Pilot,"The only data collected were baseline measurements and no participants were ever given either intervention; the investigator was never able to obtain the treatments to use for the planned intervention arm of the study, resulting in its termination. Upon resigning of his Instructor position at UMMC, the investigator backed up the baseline data files on an external hard drive. Unfortunately, some issue with the external hard drive corrupted the files, making them no longer accessible.",Vascular Dysfunction in Black Individuals: Roles of Nitric Oxide and Endothelin-1,Vascular Dysfunction in Black Individuals: Roles of Nitric Oxide and Endothelin-1,TERMINATED,,EARLY_PHASE1,8.0,ACTUAL,University of Mississippi Medical Center,"The only data collected were baseline measurements and no participants were ever given either intervention; the investigator was never able to obtain the treatments to use for the planned intervention arm of the study, resulting in its termination.",8.0,,"Despite significant effort, we were unable to obtain the supply of drugs and supplements needed for the various arms of this Clinical Trial.",f,,,,f,t,f,,,f,,,"On Jan 1st, 2025 for one year.",By request.,,YES,"Doppler ultrasound videos, analog-digital recordings, participants' characteristics, and randomization codes will be available in an unidentified format.",2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,OTHER,,,,,,,2021,0.0
NCT04655391,,2020-11-23,,,2022-06-07,2020-11-30,2020-12-07,ACTUAL,,,,,,,2022-06-07,2022-06-09,ACTUAL,2022-06-25,ESTIMATED,2022-06-25,2022-06,2022-06-30,2023-12-15,ESTIMATED,2023-12-15,2023-12-15,ESTIMATED,2023-12-15,,INTERVENTIONAL,,,Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation,A Pilot/Phase 1b Study of Glasdegib-Based Treatment Combinations in Adult Patients With Relapsed AML Post Allogeneic Hematopoietic Cell Transplantation,WITHDRAWN,,PHASE1,0.0,ACTUAL,City of Hope Medical Center,,5.0,,Drug availability,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,OTHER,,,,,,,2023,0.0
NCT00230607,,2005-09-29,2024-03-12,,2024-03-12,2005-09-29,2005-10-03,ESTIMATED,2024-03-12,2024-04-10,ACTUAL,,,,2024-03-12,2024-04-10,ACTUAL,2006-05-28,ACTUAL,2006-05-28,2024-03,2024-03-31,2024-02-09,ACTUAL,2024-02-09,2024-02-09,ACTUAL,2024-02-09,,INTERVENTIONAL,,"Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.",Study of the Effects of Fabrazyme Treatment on Lactation and Infants,"A Multicenter, Multinational Study of the Effects of Fabrazyme (Agalsidase Beta) Treatment on Lactation and Infants",TERMINATED,,PHASE4,7.0,ACTUAL,Sanofi,"This is a rare disease study, with very few participants enrolled. The study was terminated by the Sponsor. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.",1.0,,"Per FDA decision, the 2003 Post Marketing commitment has been fulfilled.",f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,INDUSTRY,,,,,,,2024,0.0
NCT04117880,,2019-09-19,,,2019-10-03,2019-10-03,2019-10-07,ACTUAL,,,,,,,2019-10-03,2019-10-07,ACTUAL,2018-12-31,ESTIMATED,2018-12-31,2019-09,2019-09-30,2021-01-31,ESTIMATED,2021-01-31,2021-01-31,ESTIMATED,2021-01-31,,INTERVENTIONAL,,,A Phase 2 Open Label Extension Study in Participants With Nonsense Mutation Aniridia,Nonsense Mutation Aniridia: An Ataluren (PTC124) Phase 2 Extension Study,WITHDRAWN,,PHASE2,0.0,ACTUAL,PTC Therapeutics,,1.0,,Study cancelled before protocol was implemented.,f,,,,,t,f,,,,,,,,,,,2024-10-16 16:49:47.467574,2024-10-16 16:49:47.467574,INDUSTRY,,,,,,,2021,0.0
NCT05443464,,2022-06-29,,,2022-12-21,2022-06-29,2022-07-05,ACTUAL,,,,,,,2022-12-21,2022-12-23,ACTUAL,2023-06-05,ESTIMATED,2023-06-05,2022-12,2022-12-31,2024-10-14,ESTIMATED,2024-10-14,2024-06-10,ESTIMATED,2024-06-10,,INTERVENTIONAL,,,Mesenchymal Stem Cells (MSCs) for Steroid Refractory Acute GVHD (SR-aGVHD),A Phase I Safety Study of Single Dose Allogeneic Bone Marrow Derived MSCs for Steroid Refractory Acute Graft vs. Host Disease,WITHDRAWN,,PHASE1,0.0,ACTUAL,"Ossium Health, Inc.",,4.0,,OSSM-001 will not be used in this program moving forward.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,INDUSTRY,,,,,,,2024,0.0
NCT06484881,,2024-06-26,,,2024-10-11,2024-06-26,2024-07-03,ACTUAL,,,,,,,2024-10-11,2024-10-15,ACTUAL,2024-09-15,ACTUAL,2024-09-15,2024-06,2024-06-30,2024-10-10,ACTUAL,2024-10-10,2024-10-10,ACTUAL,2024-10-10,,INTERVENTIONAL,,,Clinical Study of Probiotic Treatment for Androgenetic Alopecia,Clinical Study of Probiotic Treatment for Androgenetic Alopecia,WITHDRAWN,,PHASE3,0.0,ACTUAL,"Applied Biology, Inc.",,2.0,,Concern about formulation patent,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,INDUSTRY,,,,,,,2024,0.0
NCT03133897,,2017-04-21,,,2020-09-03,2017-04-25,2017-04-28,ACTUAL,,,,,,,2020-09-03,2020-09-07,ACTUAL,2018-03-05,ACTUAL,2018-03-05,2020-09,2020-09-30,2020-03-11,ACTUAL,2020-03-11,2019-08-02,ACTUAL,2019-08-02,,INTERVENTIONAL,,,Dexamethasone Versus Prednisone for Asthma Treatment in the Pediatric Inpatient Population; a Feasibility Study,Dexamethasone Versus Prednisone for Asthma Treatment in the Pediatric Inpatient Population; a Feasibility Study,TERMINATED,,PHASE3,20.0,ACTUAL,Children's Hospital of Eastern Ontario,,2.0,,"it was felt by the sponsoring institution that the current standard of oversight expected by the Health Canada regulations, would not be possible to achieve",f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,OTHER,,,,,,,2020,0.0
NCT04918771,,2021-05-21,2024-04-16,,2024-10-08,2021-06-01,2021-06-09,ACTUAL,2024-10-08,2024-10-15,ACTUAL,,,,2024-10-08,2024-10-15,ACTUAL,2021-04-29,ACTUAL,2021-04-29,2023-08,2023-08-31,2023-07-21,ACTUAL,2023-07-21,2023-07-21,ACTUAL,2023-07-21,,INTERVENTIONAL,,,Clinical Study of Efficacy and Safety of Raphamin in the Treatment of ARVI in Children 12-18 Years Old,Multicenter Double Blind Placebo-controlled Parallel-group Randomized Clinical Study of Efficacy and Safety of Raphamin in the Treatment of Acute Respiratory Viral Infection in Children Aged 12-18 Years Old,COMPLETED,,PHASE3,435.0,ACTUAL,Materia Medica Holding,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,INDUSTRY,,,,,,,2023,1.0
NCT04084665,,2019-09-09,,,2020-06-03,2019-09-09,2019-09-10,ACTUAL,,,,,,,2020-06-03,2020-06-05,ACTUAL,2020-06-01,ESTIMATED,2020-06-01,2020-06,2020-06-30,2020-07-30,ESTIMATED,2020-07-30,2020-07-30,ESTIMATED,2020-07-30,,INTERVENTIONAL,,,Biomarkers in Participants With Hidradenitis Suppurativa Receiving Guselkumab.,"A Pilot Study to Examine Safety, Activity and Biomarkers in Participants With Hidradenitis Suppurativa Receiving a Previously Tested Subcutaneous Dose of Anti-IL-23 Monoclonal Antibody Guselkumab.",WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Rockefeller University,,1.0,,COVID-19 Pandemic,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,OTHER,,,,,,,2020,0.0
NCT02181413,,2014-06-27,2019-04-15,,2024-07-11,2014-07-01,2014-07-04,ESTIMATED,2019-04-15,2019-05-07,ACTUAL,,,,2024-07-11,2024-07-23,ACTUAL,2014-07-01,ACTUAL,2014-07-01,2024-07,2024-07-31,2023-09-08,ACTUAL,2023-09-08,2018-04-16,ACTUAL,2018-04-16,,INTERVENTIONAL,,Intent-to-Treat (ITT) population was defined as all participants who were randomized and had post randomization data.,A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant,"A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Patients With Multiple Myeloma Following Autologous Stem Cell Transplant",COMPLETED,,PHASE3,656.0,ACTUAL,Takeda,,2.0,,,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,INDUSTRY,,,,,,,2023,1.0
NCT04277936,,2020-02-18,2021-06-15,,2021-07-14,2020-02-18,2020-02-20,ACTUAL,2021-07-14,2021-08-05,ACTUAL,,,,2021-07-14,2021-08-05,ACTUAL,2020-05-11,ACTUAL,2020-05-11,2021-07,2021-07-31,2020-08-31,ACTUAL,2020-08-31,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,,"Data were collected for a single subject, but study design was changed and study was discontinued. No data were analyzed.",Pharmacologic Modulation of Hippocampal Activity in Psychosis,Pharmacologic Modulation of Hippocampal Activity in Psychosis,TERMINATED,,PHASE2,1.0,ACTUAL,Vanderbilt University Medical Center,,1.0,,Study was redesigned and submitted as a new protocol (NCT04559529).,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,OTHER,,,,,,,2020,0.0
NCT04014712,,2019-07-03,,,2023-12-12,2019-07-08,2019-07-10,ACTUAL,,,,,,,2023-12-12,2023-12-19,ACTUAL,2021-04,ESTIMATED,2021-04-30,2023-12,2023-12-31,2022-08,ESTIMATED,2022-08-31,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,,,O2 Transport and Utilization in Health and Lung Disease,Role of Nitric Oxide Coupling in Muscle Dysfunction With COPD,WITHDRAWN,,PHASE1,0.0,ACTUAL,"University of Massachusetts, Amherst",,2.0,,Unable to recruit due to COVID-19 pandemic,f,,,,t,t,f,,,,,,6 months post-publication,"Within 6 months after the data have been published, and upon written request, a limited, de-identified, anonymized dataset will be created pursuant to the Data use Agreement.",,YES,,2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,OTHER,,,,,,,2022,0.0
NCT04379518,,2020-05-06,,,2023-03-02,2020-05-06,2020-05-07,ACTUAL,,,,,,,2023-03-02,2023-03-06,ACTUAL,2020-11-17,ACTUAL,2020-11-17,2023-03,2023-03-31,2023-11-17,ESTIMATED,2023-11-17,2023-11-17,ESTIMATED,2023-11-17,,INTERVENTIONAL,,,Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients,Phase 1/2A Study of Rintatolimod and IFN Alpha Regimen in Cancer Patients With COVID-19,SUSPENDED,,PHASE1/PHASE2,64.0,ESTIMATED,Roswell Park Cancer Institute,,3.0,,working on revision to protocol,,,,,t,t,f,,,t,,,,,,,,2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,OTHER,,,,,,,2023,0.0
NCT05392751,,2022-05-23,,,2024-10-10,2022-05-23,2022-05-26,ACTUAL,,,,,,,2024-10-10,2024-10-15,ACTUAL,2022-06-02,ACTUAL,2022-06-02,2024-10,2024-10-31,2024-04-24,ACTUAL,2024-04-24,2024-04-24,ACTUAL,2024-04-24,,INTERVENTIONAL,,,Dose Escalation Study to Evaluate the Safety/Tolerability and Efficacy of EA-2353 in Subjects With Retinitis Pigmentosa,"Open-label, Multiple Dose, Dose Escalation Study to Evaluate the Safety/Tolerability and Efficacy of EA-2353 in Subjects With Retinitis Pigmentosa",TERMINATED,,PHASE1/PHASE2,14.0,ACTUAL,"Endogena Therapeutics, Inc",,1.0,,Study terminated by the Sponsor. All study participants completed at least 12 months of safety follow-up instead of 24 mo. The reason for earlier termination was due to a corporate decision; not any safety concerns of EA-2353.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,INDUSTRY,,,,,,,2024,0.0
NCT04372641,,2020-05-01,,,2023-09-22,2020-05-01,2020-05-04,ACTUAL,,,,,,,2023-09-22,2023-09-25,ACTUAL,2020-06-18,ESTIMATED,2020-06-18,2023-09,2023-09-30,2021-07-12,ESTIMATED,2021-07-12,2021-07-12,ESTIMATED,2021-07-12,,INTERVENTIONAL,,,Testing the Safety of CB-5339 in Patients With Cancer,A Phase I Trial of the P97 Inhibitor CB-5339 in Patients With Advanced Solid Tumors and Lymphomas,WITHDRAWN,,PHASE1,0.0,ACTUAL,National Cancer Institute (NCI),,1.0,,Other - Clinical development of the agent has been discontinued,f,,,,t,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.",2024-10-16 16:49:47.467574,2024-10-16 16:49:47.467574,NIH,,,,,,,2021,0.0
NCT04142658,,2019-10-09,2023-07-20,,2024-03-18,2019-10-25,2019-10-29,ACTUAL,2024-03-18,2024-03-20,ACTUAL,,,,2024-03-18,2024-03-20,ACTUAL,2020-05-01,ACTUAL,2020-05-01,2024-03,2024-03-31,2022-12-12,ACTUAL,2022-12-12,2022-12-12,ACTUAL,2022-12-12,,INTERVENTIONAL,,,PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban,"A Prospective, Randomized, Active (Warfarin) Controlled, Parallel-arm Clinical Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely and Effectively on Apixaban",TERMINATED,,PHASE3,863.0,ACTUAL,Artivion Inc.,,2.0,,Safety,f,,,,t,t,t,,,,,,,,,,,2024-10-16 16:49:47.467574,2024-10-16 16:49:47.467574,INDUSTRY,,,,,,,2022,0.0
NCT04997161,,2021-06-16,2022-11-14,,2022-12-22,2021-07-30,2021-08-09,ACTUAL,2022-12-22,2023-01-19,ACTUAL,,,,2022-12-22,2023-01-19,ACTUAL,2021-08-17,ACTUAL,2021-08-17,2022-12,2022-12-31,2021-11-17,ACTUAL,2021-11-17,2021-11-17,ACTUAL,2021-11-17,,INTERVENTIONAL,GRAZE,The baseline population includes the one participant randomized in this study.,Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia,"An Open-Label, Randomised, Controlled, Parallel-Design, Multicentre, Phase IV Study of Sodium Zirconium Cyclosilicate and Enhanced Nutrition Advice Compared to Standard of Care in Dialysis Patients With Hyperkalaemia (GRAZE)",TERMINATED,,PHASE4,3.0,ACTUAL,AstraZeneca,The study was terminated by the sponsor with only 1 participant randomized. There was disconnect between dietary guidelines to limit potassium intake in dialysis and clinical practice.,2.0,,There is disconnect between dietary guidelines to limit potassium intake in dialysis and clinical practice. The number of unknowns and differences make the results unlikely to be translatable into clinical practice and will not benefit patients.,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,INDUSTRY,,,,,,,2021,0.0
NCT05276401,,2022-02-25,2023-12-14,,2024-01-05,2022-03-10,2022-03-11,ACTUAL,2024-01-05,2024-01-30,ACTUAL,,,,2024-01-05,2024-01-30,ACTUAL,2022-03-11,ACTUAL,2022-03-11,2023-12,2023-12-31,2022-06-15,ACTUAL,2022-06-15,2022-05-18,ACTUAL,2022-05-18,,INTERVENTIONAL,,,Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer,"A Phase 2a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Dose Escalating Study to Evaluate the Safety and Tolerability of Topically Applied Bisphosphocin Nu-3 Gel to Clinically Noninfected Chronic Diabetic Foot Ulcers (cDFU)",TERMINATED,,PHASE2,3.0,ACTUAL,Lakewood-Amedex Inc,Early termination leading to small numbers of subjects analyzed.,2.0,,Request for additional preclinical data.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,INDUSTRY,,,,,,,2022,0.0
NCT03269383,,2017-06-19,,,2019-04-22,2017-08-30,2017-08-31,ACTUAL,,,,,,,2019-04-22,2019-04-24,ACTUAL,2019-12,ESTIMATED,2019-12-31,2019-04,2019-04-30,2021-12,ESTIMATED,2021-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Study to Evaluate the Effectiveness of SGB in Preventing Post-op Atrial Fibrillation,Study for the Evaluation of the Effectiveness of Stellate Ganglion Blockade in Preventing Postoperative Atrial Fibrillation,WITHDRAWN,,PHASE4,0.0,ACTUAL,MaineHealth,,2.0,,Lack of funding and other logistical issues,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,OTHER,,,,,,,2021,0.0
NCT04218825,,2020-01-03,,,2023-11-08,2020-01-03,2020-01-06,ACTUAL,,,,,,,2023-11-08,2023-11-09,ACTUAL,2022-03-29,ACTUAL,2022-03-29,2023-09,2023-09-30,2023-04-04,ACTUAL,2023-04-04,2023-04-04,ACTUAL,2023-04-04,,INTERVENTIONAL,REACH,,REACH: Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL),Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL),TERMINATED,,PHASE2,2.0,ACTUAL,European Organisation for Research and Treatment of Cancer - EORTC,,1.0,,"After an extensive assessment of the study feasibility, it was decided to discontinue the clinical trial due to poor recruitment.",f,,,,t,f,f,,,,,,,,,,,2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,NETWORK,,,,,,,2023,0.0
NCT03863574,,2019-02-24,2024-07-16,,2024-09-17,2019-03-04,2019-03-05,ACTUAL,2024-09-17,2024-10-15,ACTUAL,,,,2024-09-17,2024-10-15,ACTUAL,2019-06-12,ACTUAL,2019-06-12,2024-09,2024-09-30,2020-03-20,ACTUAL,2020-03-20,2020-03-20,ACTUAL,2020-03-20,,INTERVENTIONAL,EVIDENCES VI,,Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis,"A Phase 2, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium 2 mg and 4 mg in Patients With Non-alcoholic Steatohepatitis (NASH)",COMPLETED,,PHASE2,16.0,ACTUAL,Zydus Therapeutics Inc.,,3.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,INDUSTRY,,,,,,,2020,1.0
NCT04017208,,2019-07-10,,,2024-10-15,2019-07-10,2019-07-12,ACTUAL,,,,,,,2024-10-15,2024-10-16,ESTIMATED,2019-07,ESTIMATED,2019-07-31,2019-08,2019-08-31,2020-08,ESTIMATED,2020-08-31,2020-08,ESTIMATED,2020-08-31,,INTERVENTIONAL,,,A Study to Assess ASP2713 in Healthy Subjects,"A Phase 1 Single Ascending Intravenous Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2713 in Healthy Subjects",WITHDRAWN,,PHASE1,0.0,ACTUAL,Astellas Pharma Inc,,2.0,,A business decision was made to not initiate this study.,f,,,,f,t,f,,,,,,,,,NO,Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,INDUSTRY,,,,,,,2020,0.0
NCT02471430,,2015-06-11,2024-01-05,,2024-02-01,2015-06-11,2015-06-15,ESTIMATED,2024-02-01,2024-02-28,ACTUAL,,,,2024-02-01,2024-02-28,ACTUAL,2016-05,ACTUAL,2016-05-31,2024-02,2024-02-29,2023-12,ACTUAL,2023-12-31,2022-08,ACTUAL,2022-08-31,,INTERVENTIONAL,ACTIVATE,,Reducing the Residual Reservoir of HIV-1 Infected Cells in Patients Receiving Antiretroviral Therapy,A Phase I-II Pilot Study to Assess the Safety and Efficacy of Combined Administration With Pegylated Interferon-alpha2a and the Histone Deacetylase Inhibitor (HDACi) Panobinostat for Reducing the Residual Reservoir of HIV-1 Infected Cells in cART-Treated HIV-1 Positive Individuals,COMPLETED,,PHASE1/PHASE2,17.0,ACTUAL,Massachusetts General Hospital,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,OTHER,,,,,,,2023,0.0
NCT04386252,,2020-05-11,,,2023-05-01,2020-05-11,2020-05-13,ACTUAL,,,,,,,2023-05-01,2023-05-03,ACTUAL,2023-01,ESTIMATED,2023-01-31,2023-05,2023-05-31,2024-01,ESTIMATED,2024-01-31,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,Phase I-II Trial of Dendritic Cell Vaccine to Prevent COVID-19 in Adults,"Adaptive Phase I-II Clinical Trial of Preventive Vaccine Consisting of Autologous Dendritic Cells Previously Incubated With S-protein From Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), in Subjects Negative for COVID-19 Infection and Anti-SARS-CoV-2 Antibodies",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Aivita Biomedical, Inc.",,2.0,,"The FDA put our protocol on clinical hold and never gave an okay to start, so we decided not to proceed",,,,,f,t,f,,,,,,,,,,,2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,INDUSTRY,,,,,,,2024,0.0
NCT02457598,,2015-05-27,,,2024-10-08,2015-05-28,2015-05-29,ESTIMATED,,,,,,,2024-10-08,2024-10-15,ACTUAL,2015-06-16,ACTUAL,2015-06-16,2024-10,2024-10-31,2024-09-25,ACTUAL,2024-09-25,2024-09-25,ACTUAL,2024-09-25,,INTERVENTIONAL,,,Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies,A Phase 1b Dose Escalation and Dose Expansion Study of Tirabrutinib (ONO/GS-4059) in Combination With Other Targeted Anti-cancer Therapies in Subjects With B-cell Malignancies,TERMINATED,,PHASE1,203.0,ACTUAL,Gilead Sciences,,5.0,,The goal of the study was to improve tolerability while maintaining or increasing efficacy. The results of this study showed no efficacy advantage although the combinations were well tolerated.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,INDUSTRY,,,,,,,2024,0.0
NCT05061771,,2021-09-15,,,2024-02-07,2021-09-27,2021-09-30,ACTUAL,,,,,,,2024-02-07,2024-02-08,ACTUAL,2022-05-06,ACTUAL,2022-05-06,2022-10,2022-10-31,2022-08-01,ACTUAL,2022-08-01,2022-08-01,ACTUAL,2022-08-01,,INTERVENTIONAL,ARREST-BP,,Nomacopan Therapy in Adult Patients With Bullous Pemphigoid Receiving Adjunct Oral Corticosteroid Therapy (ARREST-BP),"A Randomized, Part A Partial Blinded and Part B Double Blinded, Placebo-controlled 24-week Clinical Study to Evaluate the Efficacy and Safety of Nomacopan Therapy in Adult Patients With Bullous Pemphigoid Receiving Adjunct Oral Corticosteroid Therapy (ARREST-BP)",WITHDRAWN,,PHASE3,0.0,ACTUAL,AKARI Therapeutics,,2.0,,Akari has decided to discontinue AK802 study due to strategic resource allocation decisions.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,INDUSTRY,,,,,,,2022,0.0
NCT03733119,,2018-11-05,2022-02-11,,2022-02-11,2018-11-05,2018-11-07,ACTUAL,2022-02-11,2022-03-10,ACTUAL,,,,2022-02-11,2022-03-10,ACTUAL,2018-11-13,ACTUAL,2018-11-13,2022-02,2022-02-28,2021-02-13,ACTUAL,2021-02-13,2021-02-13,ACTUAL,2021-02-13,,INTERVENTIONAL,,,ONC201 With a Methionine-Restricted Diet in Patients With Metastatic Triple Negative Breast Cancer,ONC201 With a Methionine-Restricted Diet in Patients With Metastatic Triple Negative Breast Cancer,TERMINATED,,PHASE2,4.0,ACTUAL,"University of Wisconsin, Madison","Trial was terminated early due to slow accrual, not powered for meaningful results, statistical analysis not completed.",2.0,,Slow accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,OTHER,,,,,,,2021,0.0
NCT04513314,,2020-08-12,,,2023-03-29,2020-08-13,2020-08-14,ACTUAL,,,,,,,2023-03-29,2023-03-31,ACTUAL,2023-03-28,ESTIMATED,2023-03-28,2023-03,2023-03-31,2023-03-28,ACTUAL,2023-03-28,2023-03-28,ACTUAL,2023-03-28,,INTERVENTIONAL,,,Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium,"A Practical, Pilot, Randomized, Controlled Trial of Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium",WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Miami,,2.0,,coronavirus omicron variant infection typically not associated with delirium and agitation severely hampered recruitment.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,OTHER,,,,,,,2023,0.0
NCT04737122,,2020-11-26,,,2023-10-07,2021-02-02,2021-02-03,ACTUAL,,,,,,,2023-10-07,2023-10-10,ACTUAL,2021-05-06,ACTUAL,2021-05-06,2022-01,2022-01-31,2022-12-01,ACTUAL,2022-12-01,2022-07-19,ACTUAL,2022-07-19,,INTERVENTIONAL,,,Study of LM-061 in Subjects in Advanced Tumors,"A Phase I, First-in-Human, Open-Label, Dose Escalation Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-061 Tablet in Subjects With Advanced Tumors",TERMINATED,,PHASE1,18.0,ACTUAL,LaNova Medicines Limited,,2.0,,Failure to achieve expected outcomes,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,INDUSTRY,,,,,,,2022,0.0
NCT05492045,,2022-08-05,,,2024-10-11,2022-08-05,2022-08-08,ACTUAL,,,,,,,2024-10-11,2024-10-15,ACTUAL,2022-09-13,ACTUAL,2022-09-13,2024-10,2024-10-31,2024-06-14,ACTUAL,2024-06-14,2024-06-14,ACTUAL,2024-06-14,,INTERVENTIONAL,,,A Study to Evaluate D-1553 in Combination Therapy in Non-Small Cell Lung Cancer,"A Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combination Therapy in Subjects With KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer",TERMINATED,,PHASE1/PHASE2,22.0,ACTUAL,"InventisBio Co., Ltd",,2.0,,Adjustment of drug development strategy.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,INDUSTRY,,,,,,,2024,0.0
NCT02574455,,2015-10-08,2021-03-11,,2022-05-26,2015-10-09,2015-10-12,ESTIMATED,2021-04-29,2021-04-30,ACTUAL,,,,2022-05-26,2022-06-15,ACTUAL,2017-11-07,ACTUAL,2017-11-07,2022-05,2022-05-31,2020-12-08,ACTUAL,2020-12-08,2020-03-30,ACTUAL,2020-03-30,,INTERVENTIONAL,ASCENT,The Intent-to-Treat (ITT) Population included all randomized participants.,Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC),"An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments",COMPLETED,,PHASE3,529.0,ACTUAL,Gilead Sciences,,2.0,,,f,,,,t,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gileadclinicaltrials.com/transparency-policy/,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/",2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,INDUSTRY,,,,,,,2020,1.0
NCT05641324,,2022-11-29,,,2024-02-09,2022-11-29,2022-12-07,ACTUAL,,,,,,,2024-02-09,2024-02-12,ACTUAL,2023-02-10,ACTUAL,2023-02-10,2024-02,2024-02-29,2023-07-12,ACTUAL,2023-07-12,2023-07-12,ACTUAL,2023-07-12,,INTERVENTIONAL,,,A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2),"A Phase 1 Study of ANV419 as Monotherapy, and ANV419 in Combination With Daratumumab or With Lenalidomide Plus Low-Dose Dexamethasone, in Patients With Relapsed or Refractory Multiple Myeloma (OMNIA-2)",TERMINATED,,PHASE1,4.0,ACTUAL,Anaveon AG,,4.0,,The study was ended due to a lack of recruitment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,INDUSTRY,,,,,,,2023,0.0
NCT03733691,,2018-11-02,,,2023-10-23,2018-11-05,2018-11-07,ACTUAL,,,,,,,2023-10-23,2023-10-25,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2023-10,2023-10-31,2023-10-19,ACTUAL,2023-10-19,2023-10-19,ACTUAL,2023-10-19,,INTERVENTIONAL,,,Ph 2 Maintenance Trial: Ixazomib vs Ixazomib-Lenalidomide for MM Patients,"A Phase 2, Open Label, Randomized Trial Evaluating Ixazomib Compared to Ixazomib-Lenalidomide Combination Maintenance Therapy for Frontline Multiple Myeloma Patients",TERMINATED,,PHASE2,19.0,ACTUAL,Oncotherapeutics,,2.0,,Insufficient enrollment,,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,INDUSTRY,,,,,,,2023,0.0
NCT05165394,,2021-12-07,2024-07-03,,2024-07-03,2021-12-07,2021-12-21,ACTUAL,2024-07-03,2024-07-31,ACTUAL,,,,2024-07-03,2024-07-31,ACTUAL,2021-11-30,ACTUAL,2021-11-30,2024-07,2024-07-31,2023-09-13,ACTUAL,2023-09-13,2023-07-07,ACTUAL,2023-07-07,,INTERVENTIONAL,TERPSIS,Safety Population: All randomized participants who received at least 1 dose of study drug.,Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD,"A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in Major Depressive Disorder (TERPSIS STUDY)",COMPLETED,,PHASE2,93.0,ACTUAL,Neurocrine Biosciences,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,INDUSTRY,,,,,,,2023,1.0
NCT05965505,,2023-07-12,,,2024-07-31,2023-07-20,2023-07-28,ACTUAL,,,,,,,2024-07-31,2024-08-01,ACTUAL,2023-08-11,ACTUAL,2023-08-11,2023-07,2023-07-31,2023-09-05,ACTUAL,2023-09-05,2023-09-05,ACTUAL,2023-09-05,,INTERVENTIONAL,,,Study of AXT-1003 in Adult Subjects With Relapsed/Refractory Non-Hodgkin Lymphomas,"An Open-Label, Multicenter, Phase I Study of AXT-1003 as a Single Agent in Adult Subjects With Relapsed/Refractory Non-Hodgkin Lymphomas",TERMINATED,,PHASE1,1.0,ACTUAL,"Axter Therapeutics (Beijing) Co., Ltd",,1.0,,"Due to the adjustment of the protocol and expansion of the indication population, a new clinical trial protocol was submitted to the Health Authority, so the registration was conducted as a new clinical trial and this trial was terminated.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 09:32:54.83116,2024-10-15 09:32:54.83116,INDUSTRY,,,,,,,2023,0.0
NCT02538341,,2015-08-18,2020-10-28,,2021-10-23,2015-08-30,2015-09-02,ESTIMATED,2021-10-23,2021-11-23,ACTUAL,,,,2021-10-23,2021-11-23,ACTUAL,2016-05,ACTUAL,2016-05-31,2021-10,2021-10-31,2020-12,ACTUAL,2020-12-31,2019-12,ACTUAL,2019-12-31,,INTERVENTIONAL,,,Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial),Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial),COMPLETED,,PHASE2,617.0,ACTUAL,University of Alabama at Birmingham,,2.0,,,f,,,,t,,,,,,,,,,,YES,,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,OTHER,,,,,,,2020,1.0
NCT04838860,,2021-02-25,,,2021-04-15,2021-04-06,2021-04-09,ACTUAL,,,,,,,2021-04-15,2021-04-19,ACTUAL,2021-03-31,ACTUAL,2021-03-31,2021-03,2021-03-31,2021-04-01,ACTUAL,2021-04-01,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,SISREMCAD,,Siltuximab In Siltuximab-RElapsed/REfractory Multicentric CAstleman Disease,A Phase 2 Study of Intrapatient Siltuximab Dose Escalation in Patients With Idiopathic Multicentric Castleman Disease That Has Progressed After Prior Siltuximab Treatment,TERMINATED,,PHASE2,22.0,ACTUAL,EusaPharma (UK) Limited,,2.0,,Internal Company Decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,INDUSTRY,,,,,,,2021,0.0
NCT02856503,,2016-08-02,,,2019-01-16,2016-08-02,2016-08-05,ESTIMATED,,,,,,,2019-01-16,2019-01-18,ACTUAL,2019-01,ESTIMATED,2019-01-31,2019-01,2019-01-31,2024-01,ESTIMATED,2024-01-31,2023-01,ESTIMATED,2023-01-31,,INTERVENTIONAL,,,Effect of High Dose Vitamin D on Cancer Biomarkers and Breast Cancer Tumors,"Phase I/II Study Evaluating Safety and Effects of Preoperative High-Dose Vitamin D on the Receptors, Biomarkers and Pathological Characteristics of High Grade DCIS or Invasive Breast Cancer.",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Miami,,4.0,,Lack of Funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,OTHER,,,,,,,2024,0.0
NCT02213887,,2014-08-06,,,2021-10-01,2014-08-07,2014-08-12,ESTIMATED,,,,,,,2021-10-01,2021-10-08,ACTUAL,2014-09,,2014-09-30,2021-10,2021-10-31,2020-11-02,ACTUAL,2020-11-02,2020-11-02,ACTUAL,2020-11-02,,INTERVENTIONAL,PK-PPI,,Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications,A Pilot Study to Determine if Pantoprazole Modifies Steady-State Plasma Concentrations of Orally Administered Psychotropic Medications,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of British Columbia,,2.0,,Unable to recruit participants,f,,,,f,,,,,,,,,,,,,2024-10-16 16:49:47.467574,2024-10-16 16:49:47.467574,OTHER,,,,,,,2020,0.0
NCT04388189,,2020-05-11,,,2020-10-13,2020-05-11,2020-05-14,ACTUAL,,,,,,,2020-10-13,2020-10-19,ACTUAL,2020-10-15,ESTIMATED,2020-10-15,2020-10,2020-10-31,2023-05-30,ESTIMATED,2023-05-30,2023-05-30,ESTIMATED,2023-05-30,,INTERVENTIONAL,LEAP-DB,,Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion,"Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion (LEAP-DB): A Multicenter, Randomized, Blinded Outcome Study of EEG-guided Treatment With Duloxetine Versus Bupropion in Adults With Major Depressive Disorder",WITHDRAWN,,PHASE4,0.0,ACTUAL,Alto Neuroscience,,2.0,,No participants enrolled,f,,,,t,f,f,,,t,,,,,,UNDECIDED,,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,INDUSTRY,,,,,,,2023,0.0
NCT03695250,,2018-10-02,2022-06-02,,2023-08-19,2018-10-02,2018-10-04,ACTUAL,2023-08-19,2023-08-22,ACTUAL,,,,2023-08-19,2023-08-22,ACTUAL,2018-10-16,ACTUAL,2018-10-16,2023-08,2023-08-31,2021-03-12,ACTUAL,2021-03-12,2020-11-24,ACTUAL,2020-11-24,,INTERVENTIONAL,,,BMS-986205 and Nivolumab as First or Second Line Therapy in Treating Patients With Liver Cancer,Phase I/II Trial of BMS-986205 and Nivolumab as First or Second Line Therapy in Hepatocellular Carcinoma,TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,"University of California, Davis",,1.0,,Funding source decision to terminate study.,,,,,t,t,f,,,,,,,,,,,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,OTHER,,,,,,,2021,0.0
NCT03578198,,2018-06-25,,,2022-10-24,2018-06-25,2018-07-06,ACTUAL,,,,,,,2022-10-24,2022-10-27,ACTUAL,2018-11-08,ACTUAL,2018-11-08,2022-10,2022-10-31,2022-04-07,ACTUAL,2022-04-07,2022-04-07,ACTUAL,2022-04-07,,INTERVENTIONAL,MG4101,,Rituximab Plus MG4101 Indolent CD20-positive Non-Hodgkin Lymphoma (NHL),Phase II Study of Rituximab Plus MG4101 in Patients With Relapsed or Refractory Indolent CD20-positive Non-Hodgkin Lymphoma (NHL),TERMINATED,,PHASE2,12.0,ACTUAL,Seoul National University Hospital,,1.0,,Issues in supply of IP,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,OTHER,,,,,,,2022,0.0
NCT00265941,,2005-12-14,2017-09-26,,2022-05-23,2005-12-14,2005-12-15,ESTIMATED,2017-12-20,2017-12-21,ACTUAL,,,,2022-05-23,2022-06-14,ACTUAL,2005-11,,2005-11-30,2022-05,2022-05-31,2022-05-20,ACTUAL,2022-05-20,2011-01,ACTUAL,2011-01-31,,INTERVENTIONAL,,Eligible patients with follow-up,Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer,"A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas",COMPLETED,,PHASE3,940.0,ACTUAL,Radiation Therapy Oncology Group,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,NETWORK,,,,,,,2022,1.0
NCT03783442,,2018-12-18,2023-10-10,,2024-09-30,2018-12-19,2018-12-21,ACTUAL,2023-10-10,2023-11-07,ACTUAL,,,,2024-09-30,2024-10-15,ACTUAL,2018-12-11,ACTUAL,2018-12-11,2024-09,2024-09-30,2024-08-22,ACTUAL,2024-08-22,2022-02-28,ACTUAL,2022-02-28,,INTERVENTIONAL,,Intent-to-treat (ITT) analysis set included all randomized participants,A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma,"A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma",COMPLETED,,PHASE3,649.0,ACTUAL,BeiGene,,2.0,,,,,,,t,t,f,,,,,,,,,YES,,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,INDUSTRY,,,,,,,2024,1.0
NCT05092581,,2021-10-22,,,2022-07-26,2021-10-22,2021-10-25,ACTUAL,,,,,,,2022-07-26,2022-07-29,ACTUAL,2021-12-16,ACTUAL,2021-12-16,2022-07,2022-07-31,2022-06-09,ACTUAL,2022-06-09,2022-06-09,ACTUAL,2022-06-09,,INTERVENTIONAL,,,"COVID-19 Study of Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19","A Phase 1b, Open-Label, Single Dose Study Assessing the Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19",TERMINATED,,PHASE1,2.0,ACTUAL,Regeneron Pharmaceuticals,,1.0,,Emerging SARS-CoV-2 variants impacting susceptibility to study drug,t,,,,t,t,f,,,,,,"When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.",Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf,https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,INDUSTRY,,NCT04617535,NO_LONGER_AVAILABLE,,,,2022,0.0
NCT03322657,,2017-10-13,2021-03-12,,2021-10-19,2017-10-25,2017-10-26,ACTUAL,2021-03-12,2021-04-08,ACTUAL,,,,2021-10-19,2021-11-16,ACTUAL,2017-11-14,ACTUAL,2017-11-14,2021-10,2021-10-31,2021-02-01,ACTUAL,2021-02-01,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular,Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular Block in Patients Having Catheter-based Neurointerventional Procedures,COMPLETED,,PHASE4,69.0,ACTUAL,The Cleveland Clinic,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,OTHER,,,,,,,2021,1.0
NCT03158116,,2017-04-18,2021-07-09,,2021-07-09,2017-05-16,2017-05-17,ACTUAL,2021-07-09,2021-07-30,ACTUAL,,,,2021-07-09,2021-07-30,ACTUAL,2017-07-01,ACTUAL,2017-07-01,2021-07,2021-07-31,2020-02-20,ACTUAL,2020-02-20,2020-02-20,ACTUAL,2020-02-20,,INTERVENTIONAL,A-PACT,,The Use of Inhaled Aztreonam in Children With a Tracheostomy Tube and Pseudomonas,A-PACT: The Use of Inhaled Aztreonam to Eliminate or Decrease the Bacterial Burden of Pseudomonas Aeruginosa in Children With a Tracheostomy Tube.,TERMINATED,,PHASE4,5.0,ACTUAL,UCSF Benioff Children's Hospital Oakland,"The study has limitations with the primary one being it is a very small study. The intention was to have a larger study multi-center study. However, due to multi-site institutional research logistics and administrative bureaucracy, expanding the study was not possible.",1.0,,IRB application expired.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,OTHER,,,,,,,2020,0.0
NCT02435173,,2015-02-24,2022-02-15,,2022-08-08,2015-04-30,2015-05-06,ESTIMATED,2022-02-15,2022-03-11,ACTUAL,,,,2022-08-08,2022-08-10,ACTUAL,2015-08-24,ACTUAL,2015-08-24,2022-08,2022-08-31,2021-08-16,ACTUAL,2021-08-16,2021-08-16,ACTUAL,2021-08-16,,INTERVENTIONAL,,,Study of Efficacy of CDZ173 in Patients With APDS/PASLI,"An Open-label, Non-randomized, Within-patient Dose-finding Study Followed by a Randomized, Subject, Investigator and Sponsor Blinded Placebo Controlled Study to Assess the Efficacy and Safety of CDZ173 (Leniolisib) in Patients With APDS/PASLI (Activated Phosphoinositide 3-kinase Delta Syndrome/ p110δ-activating Mutation Causing Senescent T Cells, Lymphadenopathy and Immunodeficiency)",COMPLETED,,PHASE2/PHASE3,37.0,ACTUAL,Novartis,,3.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,INDUSTRY,,,,,,,2021,1.0
NCT03879707,,2019-02-14,,,2020-03-16,2019-03-14,2019-03-19,ACTUAL,,,,,,,2020-03-16,2020-03-18,ACTUAL,2020-06,ESTIMATED,2020-06-30,2020-03,2020-03-31,2023-06,ESTIMATED,2023-06-30,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,Improving Sleep Quality After Total Joint Arthroplasty ( TJA),Improving Sleep Quality After Total Joint Arthroplasty ( TJA),WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Stanford University,,2.0,,Investigator elected not to proceed with project,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,OTHER,,,,,,,2023,0.0
NCT04974580,,2021-07-02,2024-03-04,,2024-07-25,2021-07-13,2021-07-23,ACTUAL,2024-07-25,2024-07-29,ACTUAL,,,,2024-07-25,2024-07-29,ACTUAL,2021-07-28,ACTUAL,2021-07-28,2024-07,2024-07-31,2022-12-30,ACTUAL,2022-12-30,2022-12-30,ACTUAL,2022-12-30,,INTERVENTIONAL,(RISE),,Research and Innovation to Stop E-cigarette/Vaping in Young Adults,"Young Adult Vaping Cessation: A Randomized Trial Examining Phone Coaching, Text-based Digital Intervention, and Nicotine Replacement Therapy",COMPLETED,,PHASE4,508.0,ACTUAL,Ohio State University,,4.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 16:49:47.467574,2024-10-16 16:49:47.467574,OTHER,,,,,,,2022,1.0
NCT05571540,,2022-10-04,,,2022-11-27,2022-10-05,2022-10-07,ACTUAL,,,,,,,2022-11-27,2022-11-30,ACTUAL,2022-10-01,ACTUAL,2022-10-01,2022-11,2022-11-30,2024-10-31,ESTIMATED,2024-10-31,2024-01-31,ESTIMATED,2024-01-31,,INTERVENTIONAL,,,Anti-CD19 Universal CAR-T Cells for r/r CD19+ B-ALL,An Investigator-initiated Trial to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of Relapsed/Refractory(r/r) CD19+ B-cell Acute Lymphoblastic Leukemia(B-ALL),WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Kunming Hope of Health Hospital,,1.0,,The PI decides to stop.,f,,,,,f,f,,,,,,,,,,,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,OTHER,,,,,,,2024,0.0
NCT02270957,,2014-10-13,2020-10-06,,2022-01-19,2014-10-19,2014-10-22,ESTIMATED,2020-11-02,2020-11-25,ACTUAL,,,,2022-01-19,2022-01-26,ACTUAL,2014-01,ACTUAL,2014-01-31,2022-01,2022-01-31,2021-12,ACTUAL,2021-12-31,2018-12,ACTUAL,2018-12-31,,INTERVENTIONAL,ABC,,Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches,Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches (The ABC Study),COMPLETED,,PHASE2,66.0,ACTUAL,Oklahoma Medical Research Foundation,,2.0,,,f,,,,t,,,,,,,,June 2021-May 2023,contact the PI at joan-merrill@omrf.org,,YES,"We will share de-identified results through an application process, linked to our institutional research cohorts, where there is a standard operating procedure approval process where research is deemed to be appropriate and relevant to SLE",2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,OTHER,,,,,,,2021,1.0
NCT02523898,,2015-07-11,,,2024-04-23,2015-08-12,2015-08-14,ESTIMATED,,,,,,,2024-04-23,2024-04-25,ACTUAL,2015-11,ACTUAL,2015-11-30,2024-04,2024-04-30,2022-04,ACTUAL,2022-04-30,2022-04,ACTUAL,2022-04-30,,INTERVENTIONAL,,,Metformine and CC Compared With Placebo and CC for Induction Ovulation in PCOS Patients With Insulin Resistant,Is the Co-administration of Metformine and CC as Compared to Placebo and CC Superior to Induce Ovulation in PCOS Patients With a Confirmed insulin-resistant-a Double Blind Randomized Clinical Trial,TERMINATED,,PHASE2,388.0,ESTIMATED,Semnan University of Medical Sciences,,2.0,,"unfortunately due to COVID 19and social problems following it,we were unable to reach the estimated sample size.Evantually we could have only 151 patients .",f,,,,t,,,,,,,,,,,,,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,OTHER,,,,,,,2022,0.0
NCT04205071,,2019-08-05,,,2021-01-14,2019-12-17,2019-12-19,ACTUAL,,,,,,,2021-01-14,2021-01-19,ACTUAL,2020-11-01,ESTIMATED,2020-11-01,2021-01,2021-01-31,2021-12-31,ESTIMATED,2021-12-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Lorcaserin in Treating Chemotherapy-Induced Peripheral Neuropathy in Patients With Stage I-IV Gastrointestinal or Breast Cancer,Pilot Trial of Acute Effect of Lorcaserin to Reduce Patient-Reported Symptoms of Taxane- and Oxaliplatin-Induced Peripheral Neuropathy,WITHDRAWN,,PHASE1,0.0,ACTUAL,Ohio State University Comprehensive Cancer Center,,1.0,,PI decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,OTHER,,,,,,,2021,0.0
NCT05908513,,2021-10-04,,,2023-06-09,2023-06-09,2023-06-18,ACTUAL,,,,,,,2023-06-09,2023-06-18,ACTUAL,2021-10-15,ACTUAL,2021-10-15,2023-06,2023-06-30,2021-10-15,ACTUAL,2021-10-15,2021-10-15,ACTUAL,2021-10-15,,INTERVENTIONAL,RENEWAL,,NAC Treatment and Outcomes in Patients With Advanced Atherosclerosis and DM,Randomized Study on N-acetylcysteine Treatment and Outcomes in Patients With Advanced Atherosclerotic Heart Diseases and Diabetes Mellitus (RENEWAL),WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Missouri-Columbia,,2.0,,Lack of available resources needed to conduct study.,,,,,t,t,f,,,f,,,,,,NO,"Due to the confidential information included in this study, all data won't be shared for now.",2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,OTHER,,,,,,,2021,0.0
NCT03018704,,2017-01-10,2022-12-15,,2023-03-21,2017-01-11,2017-01-12,ESTIMATED,2023-03-21,2023-03-23,ACTUAL,,,,2023-03-21,2023-03-23,ACTUAL,2017-08-01,ACTUAL,2017-08-01,2023-03,2023-03-31,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Topiramate Treatment of Alcohol Use Disorders in African Americans,Topiramate Treatment of Alcohol Use Disorder in African Americans,TERMINATED,,PHASE4,79.0,ACTUAL,VA Office of Research and Development,The study was stopped by the funding agency due to difficulty recruiting during COVID pandemic,2.0,,In ability to recruit,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,FED,,,,,,,2021,0.0
NCT04342897,,2020-04-10,2021-08-04,,2021-08-04,2020-04-10,2020-04-13,ACTUAL,2021-08-04,2021-08-12,ACTUAL,,,,2021-08-04,2021-08-12,ACTUAL,2020-04-20,ACTUAL,2020-04-20,2021-08,2021-08-31,2020-10-12,ACTUAL,2020-10-12,2020-10-12,ACTUAL,2020-10-12,,INTERVENTIONAL,,All randomized participants who received at least 1 dose of study drug.,A Study of LY3127804 in Participants With COVID-19,"A Randomized, Double-blind, Placebo-controlled, Clinical Trial of LY3127804 in Patients Who Are Hospitalized With Pneumonia and Presumed or Confirmed COVID-19",TERMINATED,,PHASE2,95.0,ACTUAL,Eli Lilly and Company,The study was terminated for futility reason.,2.0,,Trial terminated for futility.,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting","Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting",http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,INDUSTRY,,,,,,,2020,0.0
NCT05130398,,2021-08-25,,,2023-04-18,2021-11-18,2021-11-23,ACTUAL,,,,,,,2023-04-18,2023-04-20,ACTUAL,2021-04-09,ACTUAL,2021-04-09,2023-04,2023-04-30,2022-08-09,ACTUAL,2022-08-09,2021-09-08,ACTUAL,2021-09-08,,INTERVENTIONAL,EBOLAPED,,"Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Children Living in Lambaréné, Gabon","A Phase 1/2, Randomized, Controlled Open-label Trial to Evaluate the Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Healthy Children Aged 1 to 12 Years and in Their Relatives Living in Lambaréné, Gabon",COMPLETED,,PHASE1/PHASE2,120.0,ACTUAL,Centre de Recherche Médicale de Lambaréné,,6.0,,,f,,,,t,t,f,,,t,,,From preliminary intererim analysis until the final report fo the study.The site owns the data and it is agreed that publication will occur in a timely manner.,"All files and source documents will be kept confidentially in locked safety cabinets. The Principal investigator, co-investigators and clinical research nurses will have access to records. The investigators will permit authorized representatives of the sponsor, regulatory agencies and the monitors to examine (and when required by applicable law, to copy) clinical records for the purposes of quality assurance reviews, audits and evaluation of the study safety and progress.",,YES,"The Principal investigator or his designee will be the data manager with responsibility for delegating the receiving, entering, cleaning, querying, analysing and storing all data that accrues from the study. All data will be entered in paper case record forms and transcribed by double entry into an electronic database. This includes safety data, laboratory data (both clinical and immunological) and outcome data.",2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,OTHER,,,,,,,2022,1.0
NCT05451095,,2022-07-06,,,2022-07-28,2022-07-06,2022-07-11,ACTUAL,,,,,,,2022-07-28,2022-08-01,ACTUAL,2022-11-07,ESTIMATED,2022-11-07,2022-07,2022-07-31,2023-06-20,ESTIMATED,2023-06-20,2023-06-05,ESTIMATED,2023-06-05,,INTERVENTIONAL,,,A Study in Healthy Men to Test Whether BI 474121 Can Reverse the Memory Problems Caused by Ketamine,"A Randomized, Placebo Controlled, Double-blind, Double-dummy, Three-way Crossover Trial to Investigate the Effect of Two Doses of BI 474121 on Ketamine Induced Cognitive Deficits in Healthy Male Subjects",WITHDRAWN,,PHASE1,0.0,ACTUAL,Boehringer Ingelheim,,6.0,,Termination of project,f,,,,f,t,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).~For more details refer to:~https://www.mystudywindow.com/msw/datatransparency",2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,INDUSTRY,,,,,,,2023,0.0
NCT04300114,,2020-03-05,,,2024-03-27,2020-03-05,2020-03-09,ACTUAL,,,,,,,2024-03-27,2024-03-28,ACTUAL,2020-08-19,ACTUAL,2020-08-19,2024-03,2024-03-31,2022-02-18,ACTUAL,2022-02-18,2022-02-18,ACTUAL,2022-02-18,,INTERVENTIONAL,,,A Study of Maintenance Treatment With Fluzoparib in gBRCA/PALB2 Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy,"A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Fluzoparib Monotherapy in Patients With gBRCA/PALB2 Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy",TERMINATED,,PHASE3,5.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,2.0,,Sponsor R \& D Strategy Adjustment,f,,,,,f,f,,,,,,,,,,,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,INDUSTRY,,,,,,,2022,0.0
NCT03884296,,2019-03-19,,,2023-11-17,2019-03-19,2019-03-21,ACTUAL,,,,,,,2023-11-17,2023-11-21,ACTUAL,2019-04-15,ACTUAL,2019-04-15,2023-11,2023-11-30,2023-11-17,ACTUAL,2023-11-17,2023-11-17,ACTUAL,2023-11-17,,INTERVENTIONAL,FLU-Tonsil,,Response to Live Attenuated Influenza Vaccine in Tonsillar Tissues and Blood,Response to Live Attenuated Influenza Vaccine in Tonsillar Tissues and Blood,WITHDRAWN,,PHASE4,0.0,ACTUAL,Stanford University,,1.0,,Not feasible to enroll participants,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,OTHER,,,,,,,2023,0.0
NCT03291054,,2017-09-20,2024-05-14,,2024-05-14,2017-09-20,2017-09-25,ACTUAL,2024-05-14,2024-06-11,ACTUAL,,,,2024-05-14,2024-06-11,ACTUAL,2018-02-28,ACTUAL,2018-02-28,2024-05,2024-05-31,2020-08-19,ACTUAL,2020-08-19,2020-08-19,ACTUAL,2020-08-19,,INTERVENTIONAL,,Data was not analyzed or disclosed in an effort to protect subject confidentiality (n=1).,Epacadostat and Pembrolizumab in Patients With GIST,A Phase II Study of Epacadostat and Pembrolizumab in Patients With Imatinib Refractory Advanced Gastrointestinal Stromal Tumors,TERMINATED,,PHASE2,1.0,ACTUAL,Columbia University,,1.0,,Study ended prematurely at the request of the funding sponsor.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,OTHER,,,,,,,2020,0.0
NCT04868890,,2021-04-22,2022-10-27,,2022-11-10,2021-04-26,2021-05-03,ACTUAL,2022-11-10,2022-12-07,ACTUAL,,,,2022-11-10,2022-12-07,ACTUAL,2021-06-22,ACTUAL,2021-06-22,2022-05,2022-05-31,2022-04-13,ACTUAL,2022-04-13,2022-02-16,ACTUAL,2022-02-16,,INTERVENTIONAL,,,A Study of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19,"A Randomized, Double-Blinded, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19",TERMINATED,,PHASE2,200.0,ACTUAL,Ampio Pharmaceuticals. Inc.,The AP-019 study was prematurely terminated by the sponsor after determining that insufficient events were occurring to analyze the primary endpoint.,2.0,,The AP-019 study was prematurely terminated by the sponsor after determining that insufficient events were occurring to analyze the primary endpoint.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,INDUSTRY,,,,,,,2022,0.0
NCT02892071,,2016-08-23,,,2020-03-23,2016-09-01,2016-09-08,ESTIMATED,,,,,,,2020-03-23,2020-03-25,ACTUAL,2020-12,ESTIMATED,2020-12-31,2020-03,2020-03-31,2022-09,ESTIMATED,2022-09-30,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,Tri-split Face Study of Skin Resurfacing Modalities for the Treatment of Melasma,Tri-split Face Study of Skin Resurfacing Modalities for the Treatment of Melasma,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Pittsburgh,,3.0,,Our fellow completed the program before we were able to start the study,f,,,,f,t,t,,,,,,,,,UNDECIDED,,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,OTHER,,,,,,,2022,0.0
NCT04199754,,2019-12-05,,,2024-05-30,2019-12-12,2019-12-16,ACTUAL,,,,,,,2024-05-30,2024-05-31,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2024-05,2024-05-31,2021-05-28,ACTUAL,2021-05-28,2021-05-28,ACTUAL,2021-05-28,,INTERVENTIONAL,,,IV Contrast-Enhanced Cone Beam Computed Tomography (CBCT) in Radiotherapy,Pilot Study of Intravenous Contrast-Enhanced Cone Beam Computed Tomography (CT) in Patients Receiving Radiotherapy,TERMINATED,,EARLY_PHASE1,6.0,ACTUAL,Columbia University,,1.0,,Slow accrual rate due to national contrast shortage,f,,,,t,t,t,,,t,,,,,,NO,,2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,OTHER,,,,,,,2021,0.0
NCT03982368,,2019-05-23,2021-09-23,,2024-04-17,2019-06-10,2019-06-11,ACTUAL,2022-01-13,2022-02-08,ACTUAL,,,,2024-04-17,2024-04-19,ACTUAL,2019-06-10,ACTUAL,2019-06-10,2023-12,2023-12-31,2020-07-15,ACTUAL,2020-07-15,2020-07-15,ACTUAL,2020-07-15,,INTERVENTIONAL,,Full analysis set (FAS): The FAS consisted of all patients randomized who took at least 1 dose of IMP and who had at least 1 postbaseline efficacy measurement for the primary endpoint.,A Study to Evaluate Safety and Efficacy of rhNGF Eye Solution vs Vehicle in Patients With Moderate to Severe Dry Eye,"A 4 Weeks, Phase II, Multicenter, Randomized, Double-masked, Vehicle-controlled, Parallel Group Study With 12 Weeks of Follow-up to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution vs Vehicle in Moderate to Severe Dry Eye.",COMPLETED,,PHASE2,261.0,ACTUAL,Dompé Farmaceutici S.p.A,,3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,INDUSTRY,,,,,,,2020,1.0
NCT03068130,,2017-02-22,2023-09-18,2021-09-22,2024-02-01,2017-02-24,2017-03-01,ACTUAL,2023-10-10,2023-10-12,ACTUAL,,2023-10-12,ACTUAL,2024-02-01,2024-02-06,ACTUAL,2017-04-18,ACTUAL,2017-04-18,2024-02,2024-02-29,2020-09-30,ACTUAL,2020-09-30,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,RANGER,Safety population (all patients who received at least 1 dose of bardoxolone methyl),Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER,An Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension,TERMINATED,,PHASE3,261.0,ACTUAL,Biogen,,1.0,,The company determined that continued exposure of these high-risk PH patients to clinic or in-person visits during the COVID pandemic presented an unacceptable risk.,f,,,,f,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,INDUSTRY,,,,,,,2020,0.0
NCT03951805,,2019-05-10,2020-12-11,,2021-03-05,2019-05-14,2019-05-15,ACTUAL,2020-12-11,2021-01-08,ACTUAL,,,,2021-03-05,2021-04-05,ACTUAL,2019-05-09,ACTUAL,2019-05-09,2021-03,2021-03-31,2020-01-17,ACTUAL,2020-01-17,2019-12-12,ACTUAL,2019-12-12,,INTERVENTIONAL,,The full analysis set included all randomised participants.,A Research Study to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine in People With Type 2 Diabetes Who Have Not Used Insulin Before,"A Trial Comparing NNC0148-0287 C (Insulin 287) Versus Insulin Glargine U100, Both in Combination With Metformin, With or Without DPP4 Inhibitors and With or Without SGLT2 Inhibitors, in Insulin-naïve Subjects With Type 2 Diabetes Mellitus",COMPLETED,,PHASE2,205.0,ACTUAL,Novo Nordisk A/S,,4.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,INDUSTRY,,,,,,,2020,1.0
NCT04522466,,2020-08-19,,,2020-09-04,2020-08-20,2020-08-21,ACTUAL,,,,,,,2020-09-04,2020-09-07,ACTUAL,2020-04-03,ACTUAL,2020-04-03,2020-09,2020-09-30,2020-05-28,ACTUAL,2020-05-28,2020-05-28,ACTUAL,2020-05-28,,INTERVENTIONAL,PREAVIS,,Evaluation of the Pharmacokinetics and Pharmacodynamics of Hydroxychloroquine in COVID-19 Intensive Care Unit Patients,Evaluation of the Pharmacokinetics and Pharmacodynamics of Hydroxychloroquine in COVID-19 Intensive Care Unit Patients,TERMINATED,,PHASE3,7.0,ACTUAL,Centre Hospitalier Universitaire de Saint Etienne,,1.0,,Stop of the study by competent authority (ANSM),f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,OTHER,,,,,,,2020,0.0
NCT04811924,,2021-02-22,,,2023-02-27,2021-03-22,2021-03-23,ACTUAL,,,,,,,2023-02-27,2023-02-28,ACTUAL,2021-07-26,ACTUAL,2021-07-26,2023-02,2023-02-28,2023-02-22,ACTUAL,2023-02-22,2023-02-22,ACTUAL,2023-02-22,,INTERVENTIONAL,,,The Effect of Mitomycin C on Corneal Haze and Scarring After Corneal Crosslinking in Keratoconus Patients,The Effect of Mitomycin C on Corneal Haze and Scarring After Corneal Crosslinking in Keratoconus Patients,TERMINATED,,PHASE2,4.0,ACTUAL,Ciusss de L'Est de l'Île de Montréal,,2.0,,Change in methodolody.,f,,,,,f,f,,,,,,,,,,,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,OTHER,,,,,,,2023,0.0
NCT04144335,,2019-10-28,,,2020-10-21,2019-10-28,2019-10-30,ACTUAL,,,,,,,2020-10-21,2020-10-22,ACTUAL,2020-01-01,ESTIMATED,2020-01-01,2020-10,2020-10-31,2020-12-31,ESTIMATED,2020-12-31,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,N-803 Combined With the Broadly Neutralizing Antibodies Plus or Minus haNK Cells for HIV,A Phase 1B Study of N-803 Combined With the Broadly Neutralizing Antibodies VRC07-523LS and PGT121 Plus or Minus haNK Cells for Reduction of HIV Reservoirs,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Minnesota,,2.0,,Contact issues,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,OTHER,,,,,,,2020,0.0
NCT01773395,,2013-01-08,2021-12-07,,2022-06-30,2013-01-18,2013-01-23,ESTIMATED,2022-02-23,2022-03-18,ACTUAL,,,,2022-06-30,2022-07-18,ACTUAL,2013-01-08,ACTUAL,2013-01-08,2022-06,2022-06-30,2021-11-24,ACTUAL,2021-11-24,2020-12-11,ACTUAL,2020-12-11,,INTERVENTIONAL,,Baseline Analysis Population only includes participants who received at least 1 GVAX or placebo vaccine,GVAX vs. Placebo for MDS/AML After Allo HSCT,"A Randomized Placebo-controlled Phase II Trial of Irradiated, Adenovirus Vector Transferred GM-CSF Secreting Autologous Leukemia Cell Vaccination (GVAX) Versus Placebo Vaccination in Patients With Advanced MDS/AML After Allogeneic Hematopoietic Stem Cell Transplantation",TERMINATED,,PHASE2,123.0,ACTUAL,Dana-Farber Cancer Institute,,2.0,,Recommendation by the Data and Safety Monitoring Board due to efficacy concerns,f,,,,t,,,,,,,,,,,,,2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,OTHER,,,,,,,2021,0.0
NCT04851834,,2021-04-08,,,2022-12-18,2021-04-18,2021-04-20,ACTUAL,,,,,,,2022-12-18,2022-12-20,ACTUAL,2021-08-25,ACTUAL,2021-08-25,2022-12,2022-12-31,2022-11-08,ACTUAL,2022-11-08,2022-11-08,ACTUAL,2022-11-08,,INTERVENTIONAL,,,NTX-301 Monotherapy in Advanced Solid Tumours and in Combination With Platinum-based Chemotherapy in Advanced Ovarian & Bladder Cancer and in Combination With Temozolomide in High-grade Glioma,"A Phase 1/2, Open-label, Dose-exploration and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NTX-301 Monotherapy in Advanced Solid Tumours, and in Combination With Platinum-based Chemotherapy in Advanced Ovarian & Bladder Cancer, and in Combination With Temozolomide as Adjuvant (Maintenance) Therapy in High-grade Glioma (Optional Arm)",TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,Xennials Therapeutics Australia Pty Ltd,,5.0,,"Study was terminated by IP Holder (collaborator), PinotBio Inc.",f,,,,,t,f,,,t,,,,,,,,2024-10-15 09:38:33.934005,2024-10-15 09:38:33.934005,INDUSTRY,,,,,,,2022,0.0
NCT04968938,,2021-07-09,,,2024-01-22,2021-07-09,2021-07-20,ACTUAL,,,,,,,2024-01-22,2024-01-24,ACTUAL,2022-08,ESTIMATED,2022-08-31,2024-01,2024-01-31,2023-08,ESTIMATED,2023-08-31,2023-08,ESTIMATED,2023-08-31,,INTERVENTIONAL,NUMCAP1,,Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD,"A Phase 2, Open Label Study of the Safety and Effectiveness of MDMA-assisted Therapy for Participants With Posttraumatic Stress Disorder",WITHDRAWN,,PHASE2,0.0,ACTUAL,Lykos Therapeutics,,1.0,,Sponsor decided not to pursue the study. Study ended prior to study start.,f,,,,t,t,f,,,,,,Data and study-related documents will be available when the database has been locked and data has been unblinded.,Interested persons should correspond with the central contact for the multisite study.,,YES,We will share outcome data appearing in any published reports upon request.,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,INDUSTRY,,,,,,,2023,0.0
NCT04011098,,2019-06-06,,,2020-11-02,2019-07-05,2019-07-08,ACTUAL,,,,,,,2020-11-02,2020-11-04,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2020-11,2020-11-30,2020-11-02,ACTUAL,2020-11-02,2020-11-02,ACTUAL,2020-11-02,,INTERVENTIONAL,,,Improving Labour Induction Analgesia: Epidural Fentanyl Bolus at Epidural Initiation for Induction of Labour,Improving Labour Induction Analgesia: a Randomized Control Trial of Single Epidural Fentanyl Bolus at Epidural Initiation for Induction of Labour,TERMINATED,,PHASE1,5.0,ACTUAL,University of Saskatchewan,,2.0,,"Unable to meet recruitment numbers, lack of participation",f,,,,f,f,f,,,,,,,,,,,2024-10-16 16:49:47.467574,2024-10-16 16:49:47.467574,OTHER,,,,,,,2020,0.0
NCT04712903,,2020-12-03,,,2023-07-19,2021-01-13,2021-01-15,ACTUAL,,,,,,,2023-07-19,2023-07-20,ACTUAL,2020-12-16,ACTUAL,2020-12-16,2023-07,2023-07-31,2023-06-21,ACTUAL,2023-06-21,2023-06-21,ACTUAL,2023-06-21,,INTERVENTIONAL,CANTABRICO,,Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer,"A Phase IIIB, Single Arm Study, of Durvalumab in Combination With Platinum-Etoposide for Untreated Patients With Extensive-Stage Small Cell Lung Cancer Reflecting Real World Clinical Practice in Spain (CANTABRICO).",COMPLETED,,PHASE3,101.0,ACTUAL,AstraZeneca,,1.0,,,f,,,,f,t,f,,,t,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-16 16:49:47.467574,2024-10-16 16:49:47.467574,INDUSTRY,,,,,,,2023,1.0
NCT02796144,,2016-06-06,2021-01-15,,2021-02-11,2016-06-06,2016-06-10,ESTIMATED,2021-01-15,2021-02-05,ACTUAL,,,,2021-02-11,2021-03-03,ACTUAL,2016-09,,2016-09-30,2020-05,2020-05-31,2020-02-14,ACTUAL,2020-02-14,2020-02-14,ACTUAL,2020-02-14,,INTERVENTIONAL,MELT,,MEtformin and Lorcaserin for WeighT Loss in Schizophrenia,Metformin and Lorcaserin for Weight Loss in Schizophrenia,TERMINATED,,PHASE4,71.0,ACTUAL,"University of North Carolina, Chapel Hill",,3.0,,The FDA advised of a possible health risk associated with lorcaserin and the drug is being withdrawn.,f,,,,t,,,,,,,,,,,NO,,2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,OTHER,,,,,,,2020,0.0
NCT04931862,,2021-06-11,,,2023-10-18,2021-06-11,2021-06-18,ACTUAL,,,,,,,2023-10-18,2023-10-23,ACTUAL,2021-06-28,ACTUAL,2021-06-28,2023-08,2023-08-31,2023-06-27,ACTUAL,2023-06-27,2023-06-27,ACTUAL,2023-06-27,,INTERVENTIONAL,FOCUS-C9,,Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD),"A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD)",TERMINATED,,PHASE1/PHASE2,35.0,ACTUAL,Wave Life Sciences Ltd.,,4.0,,"Despite robust, sustained reductions in poly(GP), no clinical benefit was seen at 24 weeks, and reductions in poly(GP) were not associated with stabilization in functional outcomes. Based on these data, Wave decided to stop development of WVE-004.",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,INDUSTRY,,,,,,,2023,0.0
NCT05089461,,2021-10-09,,,2022-09-07,2021-10-09,2021-10-22,ACTUAL,,,,,,,2022-09-07,2022-09-10,ACTUAL,2022-03-07,ACTUAL,2022-03-07,2022-09,2022-09-30,2022-12-30,ESTIMATED,2022-12-30,2022-06-20,ACTUAL,2022-06-20,,INTERVENTIONAL,,,A Study to Evaluate the Cardiac Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Malignant Tumor,"An Open-label, Multi-center Phase II Clinical Trial to Evaluate the Cardiac Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Malignant Tumor",SUSPENDED,,PHASE2,120.0,ESTIMATED,"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.",,1.0,,sponsor decided to stop,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,INDUSTRY,,,,,,,2022,0.0
NCT04155840,,2019-11-04,2022-03-08,,2022-04-07,2019-11-05,2019-11-07,ACTUAL,2022-04-07,2022-04-11,ACTUAL,,,,2022-04-07,2022-04-11,ACTUAL,2020-01-31,ACTUAL,2020-01-31,2022-04,2022-04-30,2021-03-16,ACTUAL,2021-03-16,2021-03-16,ACTUAL,2021-03-16,,INTERVENTIONAL,,,Bendamustine and Rituximab in Combination With Copanlisib for the Treatment of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma,MRD-Guided Abbreviation of Bendamustine and Rituximab Chemotherapy in Combination With Copanlisib in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma,TERMINATED,,PHASE2,1.0,ACTUAL,University of Washington,Low accrual precluded statistical analyses and other results analysis.,1.0,,Terminated due to low accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 16:49:47.467574,2024-10-16 16:49:47.467574,OTHER,,,,,,,2021,0.0
NCT03255473,,2017-08-16,,,2024-10-10,2017-08-18,2017-08-21,ACTUAL,,,,,,,2024-10-10,2024-10-15,ACTUAL,2017-08-30,ACTUAL,2017-08-30,2024-10,2024-10-31,2023-03-13,ACTUAL,2023-03-13,2022-08-01,ACTUAL,2022-08-01,,INTERVENTIONAL,,,High Dose Oral Steroids in Sudden Sensorineural Hearing Loss,High Dose Oral Steroids in Sudden Sensorineural Hearing Loss,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of Colorado, Denver",,2.0,,On hold due to COVID-19 outbreak,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,OTHER,,,,,,,2023,0.0
NCT04104789,,2019-09-24,,,2024-10-11,2019-09-24,2019-09-26,ACTUAL,,,,,,,2024-10-11,2024-10-15,ACTUAL,2020-09,ESTIMATED,2020-09-30,2024-10,2024-10-31,2021-10,ESTIMATED,2021-10-31,2021-09,ESTIMATED,2021-09-30,,INTERVENTIONAL,,,Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - General,Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,Virginia Commonwealth University,,2.0,,Manufacture of drug discontinued before any participants could be enrolled.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,OTHER,,,,,,,2021,0.0
NCT04134936,,2019-10-11,2023-09-12,,2024-10-11,2019-10-21,2019-10-22,ACTUAL,2024-10-11,2024-10-16,ESTIMATED,,,,2024-10-11,2024-10-16,ESTIMATED,2019-12-11,ACTUAL,2019-12-11,2024-10,2024-10-31,2022-08-10,ACTUAL,2022-08-10,2021-02-11,ACTUAL,2021-02-11,,INTERVENTIONAL,,,Phase Ib Study to Assess Safety and Preliminary Efficacy of Tafasitamab or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed DLBCL,"A Phase Ib, Open-label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab in Addition to R-CHOP or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) - First-MIND",COMPLETED,,PHASE1,66.0,ACTUAL,MorphoSys AG,,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,INDUSTRY,,,,,,,2022,1.0
NCT04231864,,2020-01-14,,,2020-10-22,2020-01-14,2020-01-18,ACTUAL,,,,,,,2020-10-22,2020-10-26,ACTUAL,2020-12-01,ESTIMATED,2020-12-01,2020-10,2020-10-31,2024-04-01,ESTIMATED,2024-04-01,2022-04-01,ESTIMATED,2022-04-01,,INTERVENTIONAL,,,"Durvalumab and Epacadostat for Treatment of Unresectable, Recurrent, or Metastatic Epstein-Barr Virus Positive Nasopharyngeal Cancer","A Multi-Center, Phase II, Open Label, Single-Arm Trial of Durvalumab and Epacadostat in Patients With Unresectable, Recurrent, and Metastatic EBV+ NPC",WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, San Francisco",,1.0,,Feasibility,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,OTHER,,,,,,,2024,0.0
NCT04899921,,2021-04-16,2023-08-16,,2024-03-22,2021-05-19,2021-05-25,ACTUAL,2023-11-22,2023-12-13,ACTUAL,,,,2024-03-22,2024-03-26,ACTUAL,2021-06-30,ACTUAL,2021-06-30,2024-03,2024-03-31,2023-05-29,ACTUAL,2023-05-29,2023-05-29,ACTUAL,2023-05-29,,INTERVENTIONAL,,Terminated with1 patient enrolled; no data due to patient privacy.,Troriluzole or Placebo Plus Ipi Plus Nivo in Mel Brain Mets,"A Blinded, Randomized Phase 2 Study of Troriluzole in Combination With Ipilimumab and Nivolumab in Patients With Melanoma Brain Metastases Previously Treated With Anti-PD-1 Therapy",TERMINATED,,PHASE2,1.0,ACTUAL,Dana-Farber Cancer Institute,,5.0,,Due to poor enrollment,f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,OTHER,,,,,,,2023,0.0
NCT04084366,,2019-09-05,,,2024-10-11,2019-09-09,2019-09-10,ACTUAL,,,,,,,2024-10-11,2024-10-15,ACTUAL,2019-11-25,ACTUAL,2019-11-25,2024-01,2024-01-31,2023-10-27,ACTUAL,2023-10-27,2023-10-27,ACTUAL,2023-10-27,,INTERVENTIONAL,,,Phase 1/2 Study of OBI-999 in Patients with Advanced Solid Tumors,"A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients with Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,44.0,ACTUAL,"OBI Pharma, Inc",,2.0,,Has not shown its expected therapeutic potential for the enrolled patients in this trial,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,INDUSTRY,,,,,,,2023,0.0
NCT03111901,,2017-03-23,,,2019-07-09,2017-04-07,2017-04-13,ACTUAL,,,,,,,2019-07-09,2019-07-12,ACTUAL,2018-10-29,ACTUAL,2018-10-29,2019-07,2019-07-31,2023-10,ESTIMATED,2023-10-31,2023-10,ESTIMATED,2023-10-31,,INTERVENTIONAL,UVA-AM-002,,Low-dose Interleukin-2 and Pembrolizumab in Melanoma and Renal Cell Cancer,Low-dose Interleukin-2 and Pembrolizumab Among Patients With Metastatic Melanoma and Renal Cell Carcinoma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Virginia,,2.0,,funding was withdrawn,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,OTHER,,,,,,,2023,0.0
NCT06507891,,2024-07-11,,,2024-07-12,2024-07-12,2024-07-18,ACTUAL,,,,,,,2024-07-12,2024-07-18,ACTUAL,2020-07-06,ACTUAL,2020-07-06,2024-07,2024-07-31,2024-06-04,ACTUAL,2024-06-04,2023-08-25,ACTUAL,2023-08-25,,INTERVENTIONAL,,,"A Clinical Study to Evaluate the Tolerance, Pharmacokinetics and Efficacy of TQ-A3334 Tablets","A Phase Ib, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance , Pharmacokinetics and Effectiveness of TQ-A3334 Tablets in Patients With Advanced Non-small Cell Lung Cancer",TERMINATED,,PHASE1/PHASE2,30.0,ACTUAL,"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",,2.0,,"After considering the company's project situation and strategic development direction, it has been decided to terminate this project. The experiment will be terminated for non safety reasons.",f,,,,,f,f,,,,,,,,,,,2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,INDUSTRY,,,,,,,2024,0.0
NCT02978716,,2016-11-18,2022-01-06,2019-07-18,2022-02-24,2016-11-28,2016-12-01,ESTIMATED,2022-02-24,2022-03-23,ACTUAL,2022-02-24,2022-03-23,ACTUAL,2022-02-24,2022-03-23,ACTUAL,2017-02-02,ACTUAL,2017-02-02,2022-02,2022-02-28,2020-02-28,ACTUAL,2020-02-28,2019-06-28,ACTUAL,2019-06-28,,INTERVENTIONAL,,The ITT analysis set included all randomized participants.,"Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)","Phase 2 Study of the Safety, Efficacy, and Pharmacokinetics of G1T28 in Patients With Metastatic Triple Negative Breast Cancer Receiving Gemcitabine and Carboplatin Chemotherapy",TERMINATED,,PHASE2,102.0,ACTUAL,"G1 Therapeutics, Inc.",Limitations of this study are the small sample size and open-label design. Antitumor outcomes were not the primary endpoints.,3.0,,Primary Analysis and survival follow up completed per protocol. Not stopped due to safety concerns,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,INDUSTRY,,,,,,,2020,0.0
NCT04476277,,2020-07-17,2023-11-16,,2024-01-17,2020-07-17,2020-07-20,ACTUAL,2024-01-17,2024-02-13,ACTUAL,,,,2024-01-17,2024-02-13,ACTUAL,2021-04-19,ACTUAL,2021-04-19,2023-02,2023-02-28,2023-02-14,ACTUAL,2023-02-14,2022-12-20,ACTUAL,2022-12-20,,INTERVENTIONAL,,,Red Cell Half Life Determination in Patients With and Without Sickle Cell Disease,Red Cell Half Life Determination in Patients With and Without Sickle Cell Disease,COMPLETED,,EARLY_PHASE1,22.0,ACTUAL,National Institutes of Health Clinical Center (CC),,4.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 16:49:47.467574,2024-10-16 16:49:47.467574,NIH,,,,,,,2023,1.0
NCT02385123,,2015-03-05,2022-02-24,,2023-10-05,2015-03-05,2015-03-11,ESTIMATED,2023-10-05,2023-10-25,ACTUAL,,,,2023-10-05,2023-10-25,ACTUAL,2015-04-01,ACTUAL,2015-04-01,2018-11,2018-11-30,2020-12-31,ACTUAL,2020-12-31,2019-12-06,ACTUAL,2019-12-06,,INTERVENTIONAL,,"Baseline characteristics were measured for all 60 participants. All participants in this study received 0.5 ml of seasonal inactivated influenza vaccine (IIV), administered intramuscularly (IM) on Day 0 of each study season.",Evaluation of Human Immune Responses to Influenza Virus Vaccination in Healthy Volunteers,Evaluation of Human Immune Responses to Influenza Virus Vaccination in Healthy Volunteers,TERMINATED,,PHASE4,60.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),"Due to the COVID-19 pandemic, all non-essential research was halted at our site (mid-March 2020). New enrollments and follow-up visits were halted, impacting the timing of participants' subsequent follow-up visits. There were participants whose Day 180 visits (final visits) were impacted. We requested an expansion of the Day 180 visit window. Due to the ongoing pandemic, our site was unable to resume participant research activities for this study, which closed to accrual on 3/31/2020.",1.0,,Study was terminated due to COVID-19 pandemic.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,NIH,,,,,,,2020,0.0
NCT02932579,,2016-09-29,2022-01-07,,2022-03-15,2016-10-11,2016-10-13,ESTIMATED,2022-03-15,2022-03-16,ACTUAL,,,,2022-03-15,2022-03-16,ACTUAL,2017-07-01,ACTUAL,2017-07-01,2022-03,2022-03-31,2021-01-13,ACTUAL,2021-01-13,2021-01-13,ACTUAL,2021-01-13,,INTERVENTIONAL,,,Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes,Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes,TERMINATED,,PHASE4,59.0,ACTUAL,University of Rochester,,2.0,,Study was halted permanently due to enrollment and logistic issues.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,OTHER,,,,,,,2021,0.0
NCT05481905,,2022-07-28,,,2023-07-03,2022-07-28,2022-08-01,ACTUAL,,,,,,,2023-07-03,2023-07-06,ACTUAL,2022-09,ESTIMATED,2022-09-30,2022-07,2022-07-31,2024-12,ESTIMATED,2024-12-31,2024-09,ESTIMATED,2024-09-30,,INTERVENTIONAL,ENACT,,ENACT: A Study of ENX-101 as Adjunctive Treatment in Patients With Focal Seizures,"The ENACT Trial: A Randomized, Double-blind, Placebo-controlled Adjunctive Treatment Trial to Evaluate the Efficacy and Safety of ENX-101 in Patients With Focal (Partial Onset) Seizures",WITHDRAWN,,PHASE2,0.0,ACTUAL,Engrail Therapeutics INC,,3.0,,Business decision,f,,,,t,t,f,,,,,,,,,,,2024-10-15 18:39:34.822917,2024-10-15 18:39:34.822917,INDUSTRY,,,,,,,2024,0.0
NCT04656691,,2020-12-04,2022-03-03,,2022-03-16,2020-12-04,2020-12-07,ACTUAL,2022-03-16,2022-03-18,ACTUAL,,,,2022-03-16,2022-03-18,ACTUAL,2021-01-04,ACTUAL,2021-01-04,2022-03,2022-03-31,2021-04-18,ACTUAL,2021-04-18,2021-04-18,ACTUAL,2021-04-18,,INTERVENTIONAL,UNITED,,At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19,At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19,TERMINATED,,PHASE4,139.0,ACTUAL,UnitedHealth Group,,1.0,,"In April 2021 FDA revoked the Emergency Use Authorization after determining that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use.",f,,,,f,t,f,,,,,,,,,NO,No plan to share participant level data with other projects or researchers.,2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,INDUSTRY,,,,,,,2021,0.0
NCT03921554,,2019-04-03,,,2024-05-22,2019-04-16,2019-04-19,ACTUAL,,,,,,,2024-05-22,2024-05-23,ACTUAL,2019-06-03,ACTUAL,2019-06-03,2024-05,2024-05-31,2024-03-25,ACTUAL,2024-03-25,2024-01-04,ACTUAL,2024-01-04,,INTERVENTIONAL,,,JAK Inhibitor Treatment in AGS,Janus Kinase Inhibitor (Baricitinib) for Aicardi Goutières Syndrome,COMPLETED,,PHASE2,54.0,ACTUAL,Children's Hospital of Philadelphia,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,OTHER,,,,,,,2024,1.0
NCT04208698,,2019-12-12,2021-07-16,,2021-08-09,2019-12-19,2019-12-23,ACTUAL,2021-08-09,2021-08-10,ACTUAL,,,,2021-08-09,2021-08-10,ACTUAL,2020-02-17,ACTUAL,2020-02-17,2021-08,2021-08-31,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,Two patients entered the Screening Period. No patients were randomized to the Treatment Period.,A Scintigraphy Study in Adults With Diabetic Gastroparesis,"A Randomized, Double-Blind Placebo-Controlled Scintigraphy Study to Investigate the Effect of CIN-102 on Gastric Emptying and Antral Contractility in Adults With Diabetic Gastroparesis",TERMINATED,,PHASE2,2.0,ACTUAL,"CinDome Pharma, Inc.",,4.0,,Trial was terminated due to the impact of COVID-19 on trial activities.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,INDUSTRY,,,,,,,2020,0.0
NCT04455802,,2020-06-08,,,2023-06-20,2020-06-30,2020-07-02,ACTUAL,,,,,,,2023-06-20,2023-06-22,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2023-06,2023-06-30,2021-05-17,ACTUAL,2021-05-17,2021-05-17,ACTUAL,2021-05-17,,INTERVENTIONAL,,,Randomized Control Trial of Buprenorphine vs. Morphine for the Treatment of Neonatal Opioid Withdrawal Syndrome (NOWS),Prospective Randomized Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS),WITHDRAWN,,PHASE3,0.0,ACTUAL,Women and Infants Hospital of Rhode Island,,2.0,,termination of funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,OTHER,,,,,,,2021,0.0
NCT04221828,,2020-01-07,2022-01-25,,2022-03-02,2020-01-07,2020-01-09,ACTUAL,2022-03-02,2022-03-29,ACTUAL,,,,2022-03-02,2022-03-29,ACTUAL,2020-10-20,ACTUAL,2020-10-20,2022-03,2022-03-31,2021-02-08,ACTUAL,2021-02-08,2021-01-27,ACTUAL,2021-01-27,,INTERVENTIONAL,,,Trial of NanoPac Focal Therapy for Prostate Cancer,Phase 2 Trial of NanoPac Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy,TERMINATED,,PHASE2,1.0,ACTUAL,"NanOlogy, LLC",Study was terminated early due to lack of enrollment.,1.0,,Lack of enrollment,t,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,INDUSTRY,,NCT03756311,AVAILABLE,,,,2021,0.0
NCT03699839,,2018-10-05,,,2020-12-15,2018-10-05,2018-10-09,ACTUAL,,,,,,,2020-12-15,2020-12-17,ACTUAL,2018-10-26,ACTUAL,2018-10-26,2020-12,2020-12-31,2020-08-15,ACTUAL,2020-08-15,2020-08-15,ACTUAL,2020-08-15,,INTERVENTIONAL,STOP-FLU,,Reducing the Burden of Influenza After Solid-Organ Transplantation,Reducing the Burden of Influenza After Solid-Organ Transplantation: the STOP-FLU Trial [Swiss Trial in Solid Organ Transplantation on Prevention of Influenza],COMPLETED,,PHASE2/PHASE3,619.0,ACTUAL,University of Lausanne Hospitals,,3.0,,,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 06:55:11.281989,2024-10-16 06:55:11.281989,OTHER,,,,,,,2020,1.0
NCT03709706,,2018-10-15,2023-06-22,,2024-02-20,2018-10-15,2018-10-17,ACTUAL,2023-08-03,2023-08-07,ACTUAL,,,,2024-02-20,2024-02-23,ACTUAL,2018-12-31,ACTUAL,2018-12-31,2024-02,2024-02-29,2022-11-04,ACTUAL,2022-11-04,2022-06-27,ACTUAL,2022-06-27,,INTERVENTIONAL,,,"Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab","A Phase 1b/2a Pilot Study to Evaluate the Safety and Tolerability of Autologous T-Cells Expressing Enhanced TCRs (T Cell Receptors) Specific for NY-ESO-1/LAGE-1a (GSK3377794) Alone, or in Combination With Pembrolizumab in HLA-A2+ Participants With NY-ESO-1- or LAGE-1a-Positive Advanced or Recurrent Non-Small Cell Lung Cancer",TERMINATED,,PHASE1/PHASE2,34.0,ACTUAL,GlaxoSmithKline,,3.0,,The study was terminated for reasons pertaining to feasibility,f,,,,f,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,INDUSTRY,,,,,,,2022,0.0
NCT03508921,,2018-03-13,2023-06-17,,2023-10-31,2018-04-24,2018-04-26,ACTUAL,2023-10-31,2023-11-02,ACTUAL,,,,2023-10-31,2023-11-02,ACTUAL,2018-07-01,ACTUAL,2018-07-01,2023-10,2023-10-31,2022-06-01,ACTUAL,2022-06-01,2022-06-01,ACTUAL,2022-06-01,,INTERVENTIONAL,,22 participants were randomized. Data is reported only for the 17 participants who fully completed both injections and all follow-up visits.,Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection,Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection: a Non-Inferiority Trial,TERMINATED,,PHASE4,22.0,ACTUAL,Vanderbilt University Medical Center,Early termination due to recruitment and follow-up challenges during the pandemic resulting in failure to accrue statistically significant sample size.,2.0,,Early termination due to recruitment and follow-up challenges during the pandemic,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,OTHER,,,,,,,2022,0.0
NCT04473924,,2020-07-13,,,2022-05-02,2020-07-13,2020-07-16,ACTUAL,,,,,,,2022-05-02,2022-05-06,ACTUAL,2022-07,ESTIMATED,2022-07-31,2022-05,2022-05-31,2023-05,ESTIMATED,2023-05-31,2023-01,ESTIMATED,2023-01-31,,INTERVENTIONAL,STIFLE-RISK,,Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk,Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, San Francisco",,2.0,,Study has never started as sponsor did not approve for funding.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,OTHER,,,,,,,2023,0.0
NCT05437419,,2022-06-23,2024-06-03,,2024-10-09,2022-06-23,2022-06-29,ACTUAL,2024-10-09,2024-10-15,ACTUAL,,,,2024-10-09,2024-10-15,ACTUAL,2022-08-10,ACTUAL,2022-08-10,2024-10,2024-10-31,2023-07-27,ACTUAL,2023-07-27,2023-07-20,ACTUAL,2023-07-20,,INTERVENTIONAL,,,"A Study to Investigate Safety, Tolerability, and PK of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis","A Phase 1, Randomized, Placebo-controlled, Double-blind, Multiple Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis",COMPLETED,,PHASE1,32.0,ACTUAL,"Teijin America, Inc.",,4.0,,,f,,,,f,t,f,,,,,,Beginning 3 months and ending 5 years following article publication.,"Researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.",,YES,"Individual participant data will be shared that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Proposals should be directed to clinical-trials-contact@teijinpo.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).",2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,INDUSTRY,,,,,,,2023,1.0
NCT01850524,,2013-04-26,2020-11-20,,2023-07-20,2013-05-06,2013-05-09,ESTIMATED,2021-01-11,2021-02-01,ACTUAL,,,,2023-07-20,2023-07-21,ACTUAL,2013-04-29,ACTUAL,2013-04-29,2023-07,2023-07-31,2022-06-24,ACTUAL,2022-06-24,2019-12-02,ACTUAL,2019-12-02,,INTERVENTIONAL,,ITT population included all participants who are randomized.,IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma,"A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma",COMPLETED,,PHASE3,705.0,ACTUAL,Takeda,,2.0,,,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,INDUSTRY,,,,,,,2022,1.0
NCT05099549,,2021-10-18,,,2024-02-28,2021-10-18,2021-10-29,ACTUAL,,,,,,,2024-02-28,2024-03-01,ACTUAL,2021-11-03,ACTUAL,2021-11-03,2023-07,2023-07-31,2023-09-21,ACTUAL,2023-09-21,2023-09-21,ACTUAL,2023-09-21,,INTERVENTIONAL,,,"Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With SNK01 in Subjects With Advanced/Metastatic EGFR-Expressing Cancers","A Phase 1/2a, Open-Label, Multi-Center Study Evaluating the Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With Ex Vivo Expanded Autologous Natural Killer Cells (SNK01) in Subjects With Advanced/Metastatic EGFR-Expressing Cancers",TERMINATED,,PHASE1/PHASE2,11.0,ACTUAL,"NKGen Biotech, Inc.",,4.0,,Affimed and NKGen have mutually decided to discontinue the study. Affimed will evaluate the best options to advance this project with an allogeneic off-the-shelf NK cell product while NKGen will focus on CNS with SNK01.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,INDUSTRY,,,,,,,2023,0.0
NCT05406765,,2022-06-01,,,2022-12-21,2022-06-01,2022-06-06,ACTUAL,,,,,,,2022-12-21,2022-12-22,ACTUAL,2022-01-01,ACTUAL,2022-01-01,2022-05,2022-05-31,2022-10-07,ACTUAL,2022-10-07,2022-10-07,ACTUAL,2022-10-07,,INTERVENTIONAL,,,Enhanced Recovery After Laparoscopic Colorectal Surgery,Spinal Analgesia for Laparoscopic Abdominoperineal Rectal Amputation Using an Enhanced Recovery After Surgery Program: a Randomized Double-blind Placebo-controlled Trial,COMPLETED,,PHASE4,10.0,ACTUAL,University Hospital of North Norway,,2.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,OTHER,,,,,,,2022,1.0
NCT04470674,,2020-07-09,,,2022-02-15,2020-07-09,2020-07-14,ACTUAL,,,,,,,2022-02-15,2022-03-03,ACTUAL,2021-04-06,ACTUAL,2021-04-06,2022-02,2022-02-28,2021-06-08,ACTUAL,2021-06-08,2021-06-08,ACTUAL,2021-06-08,,INTERVENTIONAL,,,Study of Durvalumab or Durvalumab Plus Chemotherapy in Kras Mutation Positive and PD-L1 High (≥ 50%) NSCLC Patients,Randomized Phase II Study of Durvalumab or Durvalumab Plus Chemotherapy in Kras Mutation Positive and PD-L1 High (≥ 50%) NSCLC Patients,WITHDRAWN,,PHASE2,0.0,ACTUAL,Hoosier Cancer Research Network,,2.0,,Lack of Accrual,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,OTHER,,,,,,,2021,0.0
NCT04337931,,2020-03-30,2023-12-01,2023-07-18,2024-01-18,2020-04-06,2020-04-08,ACTUAL,2023-12-21,2023-12-22,ACTUAL,,2023-09-01,ACTUAL,2024-01-18,2024-02-13,ACTUAL,2019-06-12,ACTUAL,2019-06-12,2024-01,2024-01-31,2022-08-02,ACTUAL,2022-08-02,2022-07-29,ACTUAL,2022-07-29,,INTERVENTIONAL,,The Safety Population was defined as all participants who received any sotigalimab.,A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma,"A Phase II Multicenter, Open-label Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody Sotigalimab (APX005M) With or Without Stereotactic Body Radiation Therapy in Adults With Unresectable or Metastatic Melanoma",TERMINATED,,PHASE2,45.0,ACTUAL,"Apexigen America, Inc.",,3.0,,Business decision (not due to safety reason).,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,INDUSTRY,,,,,,,2022,0.0
NCT03178864,,2017-06-01,,,2022-12-12,2017-06-05,2017-06-07,ACTUAL,,,,,,,2022-12-12,2022-12-14,ACTUAL,2019-03-12,ACTUAL,2019-03-12,2022-12,2022-12-31,2022-10-05,ACTUAL,2022-10-05,2022-10-05,ACTUAL,2022-10-05,,INTERVENTIONAL,SECRET,,Study of Rivaroxaban for CeREbral Venous Thrombosis,"Multicentre, Prospective Randomized Open Label, Blinded-endpoint (PROBE) Controlled Trial of Early Anticoagulation With Rivaroxaban Versus Standard of Care in Determining Safety at 365 Days in Symptomatic Cerebral Venous Thrombosis",COMPLETED,,PHASE2,55.0,ACTUAL,University of British Columbia,,2.0,,,f,,,,t,f,f,,,f,,,,,,YES,"Upon completion of the SECRET Trial, a public use database will be prepared by stripping any and all personal identifiers. The public use database, consisting of several data files, should contain: (1) baseline and demographic characteristics; (2) outcomes assessments; (3) CT/MRI data; (4) concomitant medications and procedures; and (5) adverse events. Each data file is made available as a formatted SAS dataset or other electronic format. The data files are distributed along with the data dictionary and a brief instruction (Readme) file. These data files will be made available to the public only after all major manuscripts (including secondary analysis papers) of the Trial are accepted for publication in peer-reviewed journals.",2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,OTHER,,,,,,,2022,1.0
NCT05283954,,2022-03-16,,,2023-03-07,2022-03-16,2022-03-17,ACTUAL,,,,,,,2023-03-07,2023-03-09,ACTUAL,2022-05-01,ESTIMATED,2022-05-01,2023-03,2023-03-31,2022-07-30,ESTIMATED,2022-07-30,2022-06-30,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,"Use of a Combined Regimen of Fluoxetine, Prednisolone and Ivermectin in the Treatment of Mild COVID-19 to Prevent Disease Progression Progression in Papua New Guinea","Use of a Combined Regimen of Fluoxetine, Prednisolone and Ivermectin in the Treatment of Mild COVID-19 to Prevent Disease Progression in Papua New Guinea: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Lihir Medical Centre,,2.0,,Lack of funding,f,,,,f,f,f,,,f,,,,,,,,2024-10-16 16:49:47.467574,2024-10-16 16:49:47.467574,OTHER,,,,,,,2022,0.0
NCT05732454,,2022-12-22,,,2024-05-21,2023-02-07,2023-02-17,ACTUAL,,,,,,,2024-05-21,2024-05-22,ACTUAL,2023-01-18,ACTUAL,2023-01-18,2024-05,2024-05-31,2024-04-29,ACTUAL,2024-04-29,2024-04-29,ACTUAL,2024-04-29,,INTERVENTIONAL,,,A Study to Learn About the Study Medicine Etrasimod in Adults With Moderate to Severe Atopic Dermatitis (AD) Who Have Already Tried Treatments Taken by Mouth or by Injection,"A PHASE 2/3, TWO-PART STUDY TO EVALUATE THE EFFICACY AND LONG-TERM SAFETY WITH ORAL ETRASIMOD, 2 MG, ONCE DAILY IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS WITH A HISTORY OF PRIOR SYSTEMIC TREATMENT FAILURE",TERMINATED,,PHASE2/PHASE3,58.0,ACTUAL,Pfizer,,2.0,,"Per the results of the planned interim analysis, the study met futility criteria for efficacy so the trial was terminated. This decision was made for efficacy reasons only and is not due to any safety concerns.",f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,INDUSTRY,,,,,,,2024,0.0
NCT04294472,,2020-02-26,2023-02-09,,2023-06-05,2020-03-02,2020-03-04,ACTUAL,2023-05-01,2023-05-24,ACTUAL,,,,2023-06-05,2023-06-07,ACTUAL,2020-08-05,ACTUAL,2020-08-05,2023-02,2023-02-28,2022-02-10,ACTUAL,2022-02-10,2022-02-10,ACTUAL,2022-02-10,,INTERVENTIONAL,,"The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. Overall Number of Baseline Participants was based on 28 randomized and treated participants.","A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients","A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics and Efficacy of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients (Neutra4)",COMPLETED,,PHASE2,30.0,ACTUAL,"Vera Therapeutics, Inc.",,4.0,,,,,,,,t,f,,,,,,,,,,,2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,INDUSTRY,,,,,,,2022,1.0
NCT00089245,,2004-08-04,,,2023-12-18,2004-08-04,2004-08-05,ESTIMATED,,,,,,,2023-12-18,2023-12-26,ACTUAL,2004-02-05,ACTUAL,2004-02-05,2023-12,2023-12-31,2022-02-02,ACTUAL,2022-02-02,2022-02-02,ACTUAL,2022-02-02,,INTERVENTIONAL,,,"Radiolabeled MAB Therapy in Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer",Phase I Study Of Intrathecal Radioimmunotherapy Using I-8H9 For Central Nervous System/Leptomeningeal Neoplasms,TERMINATED,,PHASE1,177.0,ACTUAL,Y-mAbs Therapeutics,,1.0,,Corporate business decision. No safety or efficacy concerns.,f,,,,,,,,,,,,,,,,,2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,INDUSTRY,,,,,,,2022,0.0
NCT03986944,,2019-06-06,,,2022-05-05,2019-06-13,2019-06-14,ACTUAL,,,,,,,2022-05-05,2022-05-11,ACTUAL,2019-05-23,ACTUAL,2019-05-23,2022-05,2022-05-31,2021-02-16,ACTUAL,2021-02-16,2021-01-06,ACTUAL,2021-01-06,,INTERVENTIONAL,,,A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain,"A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Assess the Efficacy and Safety of Linzagolix in Subjects With Moderate to Severe Endometriosis-associated Pain.",TERMINATED,,PHASE3,85.0,ACTUAL,ObsEva SA,,3.0,,Study halted due to the significant enrollment challenges encountered since its beginning. Screening and enrollment have been impacted by the COVID pandemic and more importantly by changes in the diagnosis and treatment of women with endometriosis.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,INDUSTRY,,,,,,,2021,0.0
NCT03284827,,2017-09-12,,,2021-11-05,2017-09-13,2017-09-15,ACTUAL,,,,,,,2021-11-05,2021-11-08,ACTUAL,2018-03-15,ACTUAL,2018-03-15,2021-11,2021-11-30,2021-11-05,ACTUAL,2021-11-05,2021-10-26,ACTUAL,2021-10-26,,INTERVENTIONAL,ADAPT-TAVR,,Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement,"a Multicenter, Randomized, Open-label, Active-treatment, Controlled Trial to Compare the Efficacy of NOAC With Edoxaban vs. Dual Antiplatelet Therapy (DAPT) for Prevention of Leaflet Thrombosis (Documented by Cardiac CT Imaging) and Cerebral Embolization (Documented With Brain DW-MRI Imaging) in Patients Without an Absolute Indication for Chronic OAC After Successful TAVR",COMPLETED,,PHASE4,235.0,ACTUAL,Asan Medical Center,,2.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,OTHER,,,,,,,2021,0.0
NCT03318757,,2017-10-15,,,2020-06-09,2017-10-19,2017-10-24,ACTUAL,,,,,,,2020-06-09,2020-06-11,ACTUAL,2020-09,ESTIMATED,2020-09-30,2020-06,2020-06-30,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,"Bupivacaine Liposomal Injectable Suspension, Pain and Narcotic Use After Elective Orthognathic Surgery",Does Bupivacaine Liposomal Injectable Suspension Decrease Post-operative Pain and Narcotic Use After Elective Orthognathic Surgery?,WITHDRAWN,,PHASE4,0.0,ACTUAL,Boston University,,2.0,,The research could not be conducted as it was denied by the IRB.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 16:49:47.467574,2024-10-16 16:49:47.467574,OTHER,,,,,,,2021,0.0
NCT04884295,,2021-05-06,,,2022-04-08,2021-05-07,2021-05-12,ACTUAL,,,,,,,2022-04-08,2022-04-15,ACTUAL,2021-08-26,ACTUAL,2021-08-26,2022-04,2022-04-30,2022-03-18,ACTUAL,2022-03-18,2022-03-18,ACTUAL,2022-03-18,,INTERVENTIONAL,,,"Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19","A 2-part Clinical Study Including a First in Human, Open Label, Single Ascending Dose Part (Phase 1) Followed by a Randomised, Double Blind, Placebo-controlled Part (Phase 2) to Evaluate the Efficacy and Safety of XVR011 in Patients Hospitalised for Mild to Moderate Coronavirus Disease 2019 (COVID-19)",TERMINATED,,PHASE1/PHASE2,27.0,ACTUAL,ExeVir Bio BV,,1.0,,The sponsor does not intend to start Part 2 (Phase 2) due to change in company strategy for phase 2 design. This early end of trial is not due to reasons of safety or lack of efficacy. Part 1 (Phase 1) is completed as per protocol.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,INDUSTRY,,,,,,,2022,0.0
NCT04460807,,2020-04-27,,,2024-02-08,2020-07-03,2020-07-08,ACTUAL,,,,,,,2024-02-08,2024-02-12,ACTUAL,2020-02-13,ACTUAL,2020-02-13,2024-02,2024-02-29,2023-04-27,ACTUAL,2023-04-27,2023-04-27,ACTUAL,2023-04-27,,INTERVENTIONAL,EXPERT,,Exemestane in Hormone Receptor Positive High Grade Ovarian Cancer,"EXemestane in Progesterone and/or Estrogen Receptor Positive Epithelial Ovarian Cancer: A Randomized Phase III Trial, EXPERT",TERMINATED,,PHASE3,23.0,ACTUAL,Ente Ospedaliero Ospedali Galliera,,2.0,,"low accrual, COVID 19 emergency and the modification of the standard of care for ovarian cancer treatment",f,,,,t,f,f,,,f,,,Data will be shared 3 months following the publication of the article and they will remain available for 36 months.,"the investigators who would like to use the data have to prepare a proposal that needs to be approved the Steering committee. The aim of the access to study data needs to be specified in the proposal. Proposals should be sent to the Principal investigator (andrea.decensi@galliera.it). To gain access, data requestors will need to sign a data access agreement.",,YES,"Individual participant data that underlie the results reported in the primary publication of the trial will be shared (text, tables, figures, and appendices), after deidentification.",2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,OTHER,,,,,,,2023,0.0
NCT05153408,,2021-11-30,,,2023-06-15,2021-11-30,2021-12-10,ACTUAL,,,,,,,2023-06-15,2023-06-18,ACTUAL,2022-01-13,ACTUAL,2022-01-13,2023-06,2023-06-30,2022-12-09,ACTUAL,2022-12-09,2022-12-09,ACTUAL,2022-12-09,,INTERVENTIONAL,,,(HARMONY) Study of BLU-701 in EGFR-mutant NSCLC,"A Phase 1/2 Study of the Highly Selective EGFR Inhibitor, BLU-701, in Patients With EGFR-Mutant Non-Small Cell Lung Cancer",TERMINATED,,PHASE1,20.0,ACTUAL,Blueprint Medicines Corporation,,4.0,,Lack of efficacy,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,INDUSTRY,,,,,,,2022,0.0
NCT03268902,,2017-08-29,,,2021-05-05,2017-08-29,2017-08-31,ACTUAL,,,,,,,2021-05-05,2021-05-10,ACTUAL,2017-09-05,ACTUAL,2017-09-05,2021-04,2021-04-30,2020-03-26,ACTUAL,2020-03-26,2020-02-28,ACTUAL,2020-02-28,,INTERVENTIONAL,ELICIT,,Early Life Interventions for Childhood Growth and Development In Tanzania,Early Life Interventions for Childhood Growth and Development In Tanzania,COMPLETED,,PHASE2/PHASE3,1188.0,ACTUAL,Haydom Lutheran Hospital,,4.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 09:44:27.345857,2024-10-15 09:44:27.345857,OTHER,,,,,,,2020,0.0
NCT02728050,,2016-03-14,2023-01-26,,2023-06-30,2016-03-30,2016-04-05,ESTIMATED,2023-06-07,2023-06-29,ACTUAL,,,,2023-06-30,2023-07-05,ACTUAL,2016-12-01,ACTUAL,2016-12-01,2023-06,2023-06-30,2023-04-04,ACTUAL,2023-04-04,2022-02-03,ACTUAL,2022-02-03,,INTERVENTIONAL,,,"Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","Addition of Sorafenib to G-CSF, Cladribine, Cytarabine and Mitoxantrone (G-CLAM) in Adults With Newly-Diagnosed Acute Myeloid Leukemia (AML) Independent of FLT3-ITD Status: A Phase 1/2 Study",COMPLETED,,PHASE1/PHASE2,84.0,ACTUAL,University of Washington,Study was limited by its single-institution and non-randomized nature,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,OTHER,,,,,,,2023,1.0
NCT03275376,,2017-09-05,,,2021-03-14,2017-09-05,2017-09-07,ACTUAL,,,,,,,2021-03-14,2021-03-16,ACTUAL,2017-12-21,ACTUAL,2017-12-21,2021-03,2021-03-31,2021-03-13,ACTUAL,2021-03-13,2020-12-21,ACTUAL,2020-12-21,,INTERVENTIONAL,,,Statin Combination Therapy in Patients Receiving Sorafenib for Advanced Hepatocellular Carcinoma,Statin Combination Therapy in Patients Receiving Sorafenib for Advanced Hepatocellular Carcinoma: A Randomized Controlled Study,TERMINATED,,PHASE2,34.0,ACTUAL,Taichung Veterans General Hospital,,2.0,,Slow in patient enrollment,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,OTHER,,,,,,,2021,0.0
NCT04160091,,2019-11-08,2021-06-15,,2024-01-22,2019-11-08,2019-11-12,ACTUAL,2021-11-01,2021-11-30,ACTUAL,,,,2024-01-22,2024-01-24,ACTUAL,2019-11-07,ACTUAL,2019-11-07,2024-01,2024-01-31,2020-06-15,ACTUAL,2020-06-15,2020-06-15,ACTUAL,2020-06-15,,INTERVENTIONAL,,,Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis (RANGE)",TERMINATED,,PHASE2,19.0,ACTUAL,"Pacira Pharmaceuticals, Inc","This study was terminated early by the Sponsor due to the COVID-19 pandemic. Summary statistics were calculated for available data, but given that only approximately 8% of the planned study population had enrolled and there no conclusions can be drawn from this study.",4.0,,The study was terminated prematurely due to the COVID-19 pandemic creating uncertainty impacting trial progress and costs.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,INDUSTRY,,,,,,,2020,0.0
NCT02480114,,2015-06-16,2020-08-12,,2021-01-28,2015-06-21,2015-06-24,ESTIMATED,2020-09-03,2020-09-24,ACTUAL,,,,2021-01-28,2021-02-18,ACTUAL,2015-07,,2015-07-31,2021-01,2021-01-31,2020-01,ACTUAL,2020-01-31,2019-09,ACTUAL,2019-09-30,,INTERVENTIONAL,,,Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy,A Randomized Phase III Trial of Gabapentin Versus Standard of Care for Prevention and Treatment of Mucositis in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation,COMPLETED,,PHASE3,79.0,ACTUAL,Vanderbilt-Ingram Cancer Center,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,OTHER,,,,,,,2020,1.0
NCT04567225,,2020-09-23,2022-06-30,,2022-08-24,2020-09-23,2020-09-28,ACTUAL,2022-08-01,2022-08-25,ACTUAL,,,,2022-08-24,2022-09-21,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2022-08,2022-08-31,2021-08-27,ACTUAL,2021-08-27,2021-08-27,ACTUAL,2021-08-27,,INTERVENTIONAL,,"Study withdrawn. The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no analysis was completed.",Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management,Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management,TERMINATED,,PHASE4,39.0,ACTUAL,The Cleveland Clinic,"The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no analysis was completed.",2.0,,Stopped after internal review,f,,,,,t,f,,,t,,,,,,NO,Individual subject results will not be shared with those involved in the prospective arm,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,OTHER,,,,,,,2021,0.0
NCT02384889,,2015-02-12,,,2021-09-03,2015-03-04,2015-03-10,ESTIMATED,,,,,,,2021-09-03,2021-09-05,ACTUAL,2015-04,,2015-04-30,2021-09,2021-09-30,2020-01-06,ACTUAL,2020-01-06,2019-10-07,ACTUAL,2019-10-07,,INTERVENTIONAL,,,DFMO in Children With Type 1 Diabetes,"Targeting Polyamines Using DFMO in Persons With Type 1 Diabetes: A Randomized, Double-Masked, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, and Initial Pharmacodynamics of Multiple Ascending Doses",COMPLETED,,PHASE1,41.0,ACTUAL,Indiana University,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,OTHER,,,,,,,2020,1.0
NCT03292588,,2017-09-20,2022-04-20,,2022-06-23,2017-09-20,2017-09-25,ACTUAL,2022-05-23,2022-06-21,ACTUAL,,,,2022-06-23,2022-07-20,ACTUAL,2017-11-07,ACTUAL,2017-11-07,2022-06,2022-06-30,2021-04-20,ACTUAL,2021-04-20,2021-04-20,ACTUAL,2021-04-20,,INTERVENTIONAL,MUPPITS-2,Intent-to-treat population with available data,A Trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthma Exacerbations in Urban Children,Mechanisms Underlying Asthma Exacerbations Prevented and Persistent With Immune-Based Therapy: A Systems Approach Phase 2 (ICAC-30),COMPLETED,,PHASE2,335.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,t,t,f,,,f,,,"After completion of the trial, within 24 months status post database lock.","Registration is available for the Immunology Database and Analysis Portal (ImmPort) at: https://www.immport.org/registration. Submit a rationale for the purpose of requesting study data access.~ImmPort is a long-term archive of clinical and mechanistic data, a National Institute of Allergy and Infectious Diseases Division of Allergy, Immunology and Transplantation (NIAID DAIT)-funded data repository. This archive is in support of the NIH mission to share data with the public. Data shared through ImmPort is provided by NIH-funded programs, other research organizations and individual scientists, ensuring these discoveries will be the foundation of future research.",https://www.immport.org/home,YES,Participant level data access and additional relevant materials will be made available upon completion of the trial.,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,NIH,,,,,,,2021,1.0
NCT01166113,,2010-07-16,,,2023-06-28,2010-07-19,2010-07-20,ESTIMATED,,,,,,,2023-06-28,2023-06-29,ACTUAL,2010-07,ACTUAL,2010-07-31,2023-06,2023-06-30,2023-06,ACTUAL,2023-06-30,2011-06,ACTUAL,2011-06-30,,INTERVENTIONAL,PCP,,"Pomalidomide, Cyclophosphamide and Prednisone (PCP) in Patients With Multiple Myeloma (MM) Relapsed and/or Refractory to Lenalidomide","A Phase I/II, Multi-center, Open Label Study of Pomalidomide, Cyclophosphamide and Prednisone (PCP) in Patients With Multiple Myeloma Relapsed and/or Refractory to Lenalidomide",COMPLETED,,PHASE1/PHASE2,67.0,ACTUAL,Fondazione EMN Italy Onlus,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,OTHER,,,,,,,2023,1.0
NCT03283371,,2017-09-12,2020-12-24,,2021-11-17,2017-09-12,2017-09-14,ACTUAL,2021-04-26,2021-04-27,ACTUAL,,,,2021-11-17,2021-12-14,ACTUAL,2018-03-20,ACTUAL,2018-03-20,2021-11,2021-11-30,2020-11-18,ACTUAL,2020-11-18,2020-01-11,ACTUAL,2020-01-11,,INTERVENTIONAL,OPUS,The Intent to Treat (ITT) population is defined as all participants who were randomized and received any dose of study treatment. Ethnicity was not collected in this study.,"Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy","A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Exploring the Efficacy, Safety, and Tolerability of Natalizumab (BG00002) as Adjunctive Therapy in Adult Subjects With Drug-Resistant Focal Epilepsy",COMPLETED,,PHASE2,67.0,ACTUAL,Biogen,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,INDUSTRY,,,,,,,2020,1.0
NCT03838848,,2019-02-01,,,2023-02-28,2019-02-10,2019-02-12,ACTUAL,,,,,,,2023-02-28,2023-03-02,ACTUAL,2019-05-05,ACTUAL,2019-05-05,2023-02,2023-02-28,2022-07-30,ACTUAL,2022-07-30,2022-07-30,ACTUAL,2022-07-30,,INTERVENTIONAL,,,KN046 in Patients With Advanced Non-small Cell Lung Cancer,"A Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of KN046 in Patients With Advanced Non-small Cell Lung Cancer",TERMINATED,,PHASE2,120.0,ACTUAL,"Jiangsu Alphamab Biopharmaceuticals Co., Ltd",,5.0,,"Cohort A,B,C end enrollments. Cohort D and E were considered to have no significant clinical benefit at the SMC meeting and decided to terminate enrollment.",f,,,,,f,f,,,,,,,,,NO,,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,INDUSTRY,,,,,,,2022,0.0
NCT01950507,,2013-09-21,,,2021-03-11,2013-09-21,2013-09-25,ESTIMATED,,,,,,,2021-03-11,2021-03-12,ACTUAL,2014-02-20,ACTUAL,2014-02-20,2020-03,2020-03-31,2020-02-26,ACTUAL,2020-02-26,2018-05-10,ACTUAL,2018-05-10,,INTERVENTIONAL,,,Evaluation of Budesonide and How It Interacts With Antifungal Drugs in People With Gastrointestinal Graft-Versus-Host Disease,Evaluation of Serum Concentrations of Budesonide in Patients Treated for Gastrointestinal Graft-Versus-Host Disease and the Potential Interaction With Fluconazole or Voriconazole,TERMINATED,,PHASE1,15.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,Slow/Insufficient accrual,f,,,,,t,f,,,,,,,,,,,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,NIH,,,,,,,2020,0.0
NCT03393962,,2017-12-28,,,2018-07-30,2018-01-03,2018-01-09,ACTUAL,,,,,,,2018-07-30,2018-07-31,ACTUAL,2017-12-01,ACTUAL,2017-12-01,2018-07,2018-07-31,2020-12,ESTIMATED,2020-12-31,2020-01,ESTIMATED,2020-01-31,,INTERVENTIONAL,,,Intervention of Ovarian Cancer With Antigen-specific Engineered Immune Effectors,Interventional Treatment of Ovarian Cancer With Cancer Antigen-specific Engineered Immune Effector T Lymphocytes (OC-EIEs),SUSPENDED,,PHASE1/PHASE2,20.0,ESTIMATED,Shenzhen Geno-Immune Medical Institute,,1.0,,combine with another trial,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,OTHER,,,,,,,2020,0.0
NCT04984798,,2020-12-03,,,2022-12-09,2021-07-28,2021-08-02,ACTUAL,,,,,,,2022-12-09,2022-12-13,ACTUAL,2022-11,ESTIMATED,2022-11-30,2022-12,2022-12-31,2023-03,ESTIMATED,2023-03-31,2023-03,ESTIMATED,2023-03-31,,INTERVENTIONAL,,,Vitamin E Efficacy in HI/HA,Efficacy of Vitamin E in Hyperinsulinism/Hyperammonemia Syndrome,WITHDRAWN,,PHASE2,0.0,ACTUAL,Children's Hospital of Philadelphia,,1.0,,No study activity took place. The IND was withdrawn with the FDA by the Sponsor Investigator because of insurmountable hurdles in moving proposed research forward,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,OTHER,,,,,,,2023,0.0
NCT05420077,,2022-06-07,,,2023-06-23,2022-06-14,2022-06-15,ACTUAL,,,,,,,2023-06-23,2023-06-27,ACTUAL,2022-09-12,ACTUAL,2022-09-12,2023-06,2023-06-30,2023-06-02,ACTUAL,2023-06-02,2023-06-02,ACTUAL,2023-06-02,,INTERVENTIONAL,,,Safety and Immunogenicity of RVM-V001 in Healthy Individuals Previously Vaccinated With BNT162b2 and mRNA-1273,"Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of RVM-V001 in Healthy Individuals Aged 18-65 Years Previously Vaccinated With BNT162b2 and mRNA-1273",TERMINATED,,PHASE1,13.0,ACTUAL,"RVAC Medicines (US), Inc.",,3.0,,"The landscape of the study area changed, making it impossible to continue the study.",f,,,,t,f,f,,,,,,,,,,,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,OTHER,,,,,,,2023,0.0
NCT02414750,,2015-02-11,,,2022-11-24,2015-04-07,2015-04-13,ESTIMATED,,,,,,,2022-11-24,2022-11-30,ACTUAL,2014-12,,2014-12-31,2022-11,2022-11-30,2020-11,ACTUAL,2020-11-30,2020-11,ACTUAL,2020-11-30,,INTERVENTIONAL,REPOSIT,,Vemurafenib Plus Cobimetinib in Metastatic Melanoma,"A Phase II, Open-Label, Multicenter Study of Vemurafenib Plus Cobimetinib (GDC-0973) in Unresectable Stage IIIc or Stage IV Melanoma; Response Monitoring and Resistance Prediction With Positron Emission Tomography and Tumor Characteristics",TERMINATED,,PHASE2,78.0,ACTUAL,Netherlands Working Group on Immunotherapy of Oncology,,1.0,,Slow accrual and changing treatment landscape,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,OTHER,,,,,,,2020,0.0
NCT03110380,,2017-04-07,2019-11-01,,2021-12-14,2017-04-07,2017-04-12,ACTUAL,2019-11-01,2019-11-20,ACTUAL,,,,2021-12-14,2022-01-11,ACTUAL,2017-06-12,ACTUAL,2017-06-12,2021-12,2021-12-31,2021-02-10,ACTUAL,2021-02-10,2018-12-04,ACTUAL,2018-12-04,,INTERVENTIONAL,,The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.,Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed,"A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed",COMPLETED,,PHASE3,567.0,ACTUAL,Gilead Sciences,,4.0,,,f,,,,t,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy",2024-10-16 16:49:47.467574,2024-10-16 16:49:47.467574,INDUSTRY,,,,,,,2021,1.0
NCT04530149,,2020-08-25,2024-05-14,,2024-05-14,2020-08-25,2020-08-28,ACTUAL,2024-05-14,2024-06-11,ACTUAL,,,,2024-05-14,2024-06-11,ACTUAL,2021-11-01,ACTUAL,2021-11-01,2024-05,2024-05-31,2024-03-04,ACTUAL,2024-03-04,2024-03-04,ACTUAL,2024-03-04,,INTERVENTIONAL,,,Vital Capacity in Ultrasound Guided Serratus Plane Block in ED Patients With Multiple Rib Fractures,Vital Capacity in Ultrasound Guided Serratus Plane Block in Emergency Department Patients With Multiple Rib Fractures: A Randomized Controlled Trial,TERMINATED,,PHASE4,3.0,ACTUAL,Maimonides Medical Center,,2.0,,The original PI left the institution; COVID interrupted the study; difficult enrolling patients.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,OTHER,,,,,,,2024,0.0
NCT05715125,,2023-01-19,,,2024-01-04,2023-02-04,2023-02-06,ACTUAL,,,,,,,2024-01-04,2024-01-08,ACTUAL,2023-01-31,ACTUAL,2023-01-31,2024-01,2024-01-31,2024-01-02,ACTUAL,2024-01-02,2024-01-02,ACTUAL,2024-01-02,,INTERVENTIONAL,,,VTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA),"A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Patients With Active Psoriatic Arthritis",TERMINATED,,PHASE2,205.0,ACTUAL,"Ventyx Biosciences, Inc",,3.0,,sponsor decision,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,INDUSTRY,,,,,,,2024,0.0
NCT04110054,,2019-09-26,2023-12-07,2021-12-07,2024-03-01,2019-09-27,2019-10-01,ACTUAL,2024-03-01,2024-03-27,ACTUAL,,2024-03-27,ACTUAL,2024-03-01,2024-03-27,ACTUAL,2020-02-13,ACTUAL,2020-02-13,2024-03,2024-03-31,2020-12-28,ACTUAL,2020-12-28,2020-12-08,ACTUAL,2020-12-08,,INTERVENTIONAL,,Full Analysis Set included all randomized participants who received at least 1 dose of study drug and who had cough monitor assessment at both baseline and at least 1 visit after initiation of study drug administration.,Evaluation of S-600918 in Adults With Refractory Chronic Cough,"A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-selection Study of S-600918 in Patients With Refractory Chronic Cough",COMPLETED,,PHASE2,406.0,ACTUAL,Shionogi Inc.,,4.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,INDUSTRY,,,,,,,2020,1.0
NCT04808362,,2021-03-16,2023-10-16,,2024-04-23,2021-03-18,2021-03-22,ACTUAL,2024-04-23,2024-04-25,ACTUAL,,,,2024-04-23,2024-04-25,ACTUAL,2021-04-28,ACTUAL,2021-04-28,2024-04,2024-04-30,2023-01-11,ACTUAL,2023-01-11,2022-12-15,ACTUAL,2022-12-15,,INTERVENTIONAL,MYCure,,"Phase 1/2 Study to Evaluate Safety, PK and Efficacy of the MYC-Inhibitor OMO-103 in Solid Tumours","A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumour Activity of the MYC Inhibitor OMO-103 Administered Intravenously in Patients With Advanced Solid Tumours",TERMINATED,,PHASE1/PHASE2,22.0,ACTUAL,Peptomyc S.L.,,1.0,,Phase 1completed; sponsor decided to change strategy to a combination study,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 16:49:47.467574,2024-10-16 16:49:47.467574,INDUSTRY,,,,,,,2023,0.0
NCT04386980,,2020-05-08,,,2021-11-02,2020-05-12,2020-05-13,ACTUAL,,,,,,,2021-11-02,2021-11-09,ACTUAL,2021-04,ESTIMATED,2021-04-30,2021-11,2021-11-30,2022-06,ESTIMATED,2022-06-30,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,Study to Evaluate Resiniferatoxin in Patients With Knee Osteoarthritis Whose Total Knee Replacement Surgery is Delayed,"A Phase 3, Randomized, Multi-center, Blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intra-articular Resiniferatoxin Versus Placebo to Manage Pain in Patients With Osteoarthritis of the Knee Whose Total Knee Replacement Surgery is Delayed",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,2.0,,To be replaced by a different protocol,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,INDUSTRY,,,,,,,2022,0.0
NCT04251169,,2020-01-30,,,2024-06-05,2020-01-30,2020-01-31,ACTUAL,,,,,,,2024-06-05,2024-06-07,ACTUAL,2020-07-21,ACTUAL,2020-07-21,2024-06,2024-06-30,2024-04-30,ACTUAL,2024-04-30,2024-04-10,ACTUAL,2024-04-10,,INTERVENTIONAL,TATEN,,Pembrolizumab + Paclitaxel in Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2-negative (HER2-) Non-luminal (by PAM50) Advanced Breast Cancer After Cyclin-dependent Kinase 4/6 (CDK4/6) Inhibitors Progression,"Targeting Non-Luminal Disease by PAM50 With Pembrolizumab + Paclitaxel in Hormone Receptor-positive/HER2-negative Advanced/Metastatic Breast Cancer, Who Have Progressed on or After CDK 4/6 Inhibitor Treatment",TERMINATED,,PHASE2,20.0,ACTUAL,SOLTI Breast Cancer Research Group,,1.0,,The enrollment was stopped prematurely due to the lack of funding,f,,,,t,f,f,,,,,,,,,,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,OTHER,,,,,,,2024,0.0
NCT04532749,,2020-08-27,,2023-05-21,2024-04-24,2020-08-27,2020-08-31,ACTUAL,,,,,2023-05-24,ACTUAL,2024-04-24,2024-04-26,ACTUAL,2020-09-15,ACTUAL,2020-09-15,2024-04,2024-04-30,2022-07-14,ACTUAL,2022-07-14,2022-05-24,ACTUAL,2022-05-24,,INTERVENTIONAL,,,A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy,"A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy",TERMINATED,,PHASE3,212.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,42847922MDD3002 was stopped based on the interim analysis (IA) results as recommended by the Independent Data Monitoring Committee (IDMC),f,,,,t,t,f,,,f,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu",2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,INDUSTRY,,,,,,,2022,0.0
NCT04638400,,2020-10-07,2022-11-28,,2023-12-28,2020-11-16,2020-11-20,ACTUAL,2023-12-28,2024-01-23,ACTUAL,,,,2023-12-28,2024-01-23,ACTUAL,2017-05-01,ACTUAL,2017-05-01,2023-12,2023-12-31,2021-11-01,ACTUAL,2021-11-01,2021-08-01,ACTUAL,2021-08-01,,INTERVENTIONAL,,,Anti-inflammatory Effects of Simvastatin,Comparison of Effects of Simvastatin Versus Ezetimibe on Intracellular Lipid and Inflammation in Obese Subjects,TERMINATED,,PHASE4,10.0,ACTUAL,State University of New York at Buffalo,,2.0,,Lack of recruitment- Fellow responsible for study graduated,f,,,,,t,f,,,t,,,,,,,,2024-10-16 16:49:47.467574,2024-10-16 16:49:47.467574,OTHER,,,,,,,2021,0.0
NCT04346394,,2020-03-10,,,2023-08-21,2020-04-13,2020-04-15,ACTUAL,,,,,,,2023-08-21,2023-08-23,ACTUAL,2021-05-11,ACTUAL,2021-05-11,2023-08,2023-08-31,2023-08-01,ACTUAL,2023-08-01,2023-08-01,ACTUAL,2023-08-01,,INTERVENTIONAL,NAinPD,,The Role of the Noradrenergic System in the Nonmotor Symptoms of Parkinson's Disease,The Role of the Noradrenergic System in the Nonmotor Symptoms of Parkinson's Disease: Orthostatic Hypotension and Other Nonmotor Symptoms,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Dartmouth-Hitchcock Medical Center,,1.0,,COVID-19,f,,,,f,t,f,,,,,,,,,,,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,OTHER,,,,,,,2023,0.0
NCT04705597,,2021-01-04,2023-04-20,,2023-06-29,2021-01-08,2021-01-12,ACTUAL,2023-06-29,2023-07-03,ACTUAL,,,,2023-06-29,2023-07-03,ACTUAL,2021-03-18,ACTUAL,2021-03-18,2023-06,2023-06-30,2022-05-19,ACTUAL,2022-05-19,2022-04-20,ACTUAL,2022-04-20,,INTERVENTIONAL,,The Intent-to-Treat (ITT) Analysis Set includes all randomized participants and was used for baseline characteristics,"Study to Evaluate the Safety, Tolerability, and Efficacy of BGE-175 in Hospitalized Adults With Coronavirus Disease 2019 (COVID-19) That Are Not in Respiratory Failure","A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy and Safety of BGE-175 in Hospitalized Adults With COVID-19",TERMINATED,,PHASE2,194.0,ACTUAL,"BioAge Labs, Inc.",,2.0,,The incidence of COVID-19 hospitalization cases decreased to a level that continued enrollment was no longer feasible,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,INDUSTRY,,,,,,,2022,0.0
NCT03085810,,2017-03-16,,,2023-10-23,2017-03-16,2017-03-21,ACTUAL,,,,,,,2023-10-23,2023-10-24,ACTUAL,2017-03-24,ACTUAL,2017-03-24,2023-10,2023-10-31,2023-04-27,ACTUAL,2023-04-27,2023-04-27,ACTUAL,2023-04-27,,INTERVENTIONAL,,,Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS),"An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis",COMPLETED,,PHASE3,1239.0,ACTUAL,Hoffmann-La Roche,,3.0,,,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,INDUSTRY,,,,,,,2023,1.0
NCT02588807,,2015-10-27,,,2022-08-07,2015-10-27,2015-10-28,ESTIMATED,,,,,,,2022-08-07,2022-08-09,ACTUAL,2021-01-01,ESTIMATED,2021-01-01,2022-08,2022-08-31,2022-05,ESTIMATED,2022-05-31,2021-09,ESTIMATED,2021-09-30,,INTERVENTIONAL,ALS-PHL,,Food Supplement for the Treatment of Patients With Amyotrophic Lateral Sclerosis,The Combination of Phospholipids and Medical Herbs for the Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS); A Pilot Study,WITHDRAWN,,PHASE1,0.0,ACTUAL,Herb Spirit,,1.0,,The sponsor and hospital did not reach agreement,f,,,,f,f,f,,,,,,,,,,,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,INDUSTRY,,,,,,,2022,0.0
NCT04338022,,2020-04-06,,,2024-04-25,2020-04-06,2020-04-08,ACTUAL,,,,,,,2024-04-25,2024-04-29,ACTUAL,2020-06-12,ACTUAL,2020-06-12,2024-04,2024-04-30,2024-03-08,ACTUAL,2024-03-08,2023-10-02,ACTUAL,2023-10-02,,INTERVENTIONAL,,,Study of Evobrutinib in Participants With RMS (evolutionRMS 1),"A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 1)",TERMINATED,,PHASE3,1124.0,ACTUAL,"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany",,2.0,,Results from the EVOLUTION clinical trials showed evobrutinib did not meet its primary endpoint of annualized relapse rate for up to 156 weeks compared to oral teriflunomide in both studies.,f,,,,,t,f,,,,,,Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union,Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.,http://bit.ly/IPD21,YES,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21",2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,INDUSTRY,,,,,,,2024,0.0
NCT04337749,,2020-04-05,,,2024-03-25,2020-04-05,2020-04-08,ACTUAL,,,,,,,2024-03-25,2024-03-27,ACTUAL,2022-11-05,ESTIMATED,2022-11-05,2024-03,2024-03-31,2022-12-01,ESTIMATED,2022-12-01,2022-12-01,ESTIMATED,2022-12-01,,INTERVENTIONAL,PKprevention,,"Chlorhexidine Scrub, ZnO Nanoparticles Socks and the Combination for Prevention of Pitted Keratolysis","A Study of Efficacy of Chlorhexidine Scrub, ZnO Nanoparticles Socks and the Combination of Chlorhexidine Scrub and ZnO Nanoparticles Socks for Prevention of Pitted Keratolysis",WITHDRAWN,,PHASE4,0.0,ACTUAL,Mahidol University,,4.0,,"After discussing within the team, the project has been withdrawn due to the anticipated insufficiency of sample size.",f,,,,f,f,f,,,,,,,,,NO,There is not a plan to make IPD available.,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,OTHER,,,,,,,2022,0.0
NCT03281681,,2017-09-06,,,2019-10-16,2017-09-11,2017-09-13,ACTUAL,,,,,,,2019-10-16,2019-10-18,ACTUAL,2021-03,ESTIMATED,2021-03-31,2019-10,2019-10-31,2022-09,ESTIMATED,2022-09-30,2022-03,ESTIMATED,2022-03-31,,INTERVENTIONAL,REPROVe,,A Multi-center Study of VAL-083 in Patients With Recurrent Platinum Resistant Ovarian Cancer,"A Phase 1/2, Open Label, Multi-center Study of VAL-083 in Patients With Recurrent Platinum Resistant Ovarian Cancer",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Kintara Therapeutics, Inc.",,1.0,,Alternate study design for ovarian cancer under discussion,t,,,,f,t,f,,,,,,,,,NO,The Clinical Study Report for this trial will be prepared and provided to the U.S. FDA as required by applicable regulatory requirement(s). Each participating trial investigator will be provided a copy of their patient data captured in the database for this trial.,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,INDUSTRY,,NCT03138629,NO_LONGER_AVAILABLE,,,,2022,0.0
NCT02097225,,2014-03-24,2023-11-30,,2024-09-20,2014-03-24,2014-03-27,ESTIMATED,2024-09-20,2024-10-16,ESTIMATED,,,,2024-09-20,2024-10-16,ESTIMATED,2014-05-29,ACTUAL,2014-05-29,2024-09,2024-09-30,2022-10-26,ACTUAL,2022-10-26,2019-03-31,ACTUAL,2019-03-31,,INTERVENTIONAL,,No participants were enrolled into fallback Dose Level -1 because Dose Level -1 is only initiated if more than 1 of 6 subjects in dose level 1 (starting dose) develop DLTs.,"Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery",Phase I Study of AT13387 in Combination With Dabrafenib and Trametinib in Patients With BRAF-Mutant Melanoma and Other Solid Tumors,TERMINATED,,PHASE1,22.0,ACTUAL,National Cancer Institute (NCI),,5.0,,Drug supply issues,f,,,,f,,,,,,,,,,,,,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,NIH,,,,,,,2022,0.0
NCT04238663,,2020-01-16,2021-02-03,,2023-10-20,2020-01-20,2020-01-23,ACTUAL,2021-02-03,2021-02-24,ACTUAL,,,,2023-10-20,2023-10-25,ACTUAL,2019-09-24,ACTUAL,2019-09-24,2021-03,2021-03-31,2020-03-17,ACTUAL,2020-03-17,2020-03-17,ACTUAL,2020-03-17,,INTERVENTIONAL,,,Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers,"A Randomised, Double Blind, Three-Arm, Single Dose, Parallel Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (Bevacizumab Biosimilar Drug), US Licenced Avastin® and EU Approved Avastin® in Healthy Male Volunteers",COMPLETED,,PHASE1,115.0,ACTUAL,mAbxience Research S.L.,,3.0,,,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,INDUSTRY,,,,,,,2020,0.0
NCT02448420,,2015-05-08,,,2024-04-17,2015-05-14,2015-05-19,ESTIMATED,,,,,,,2024-04-17,2024-04-18,ACTUAL,2015-07,ACTUAL,2015-07-31,2024-04,2024-04-30,2023-11-30,ACTUAL,2023-11-30,2023-09-29,ACTUAL,2023-09-29,,INTERVENTIONAL,PATRICIA II,,Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer,A Phase II Trial of Palbociclib in Combination With Trastuzumab and Endocrine Therapy in Patients With Previously-treated Locally Advanced or Metastatic HER2-positive Breast Cancer (PATRICIA II),COMPLETED,,PHASE2,73.0,ACTUAL,SOLTI Breast Cancer Research Group,,5.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,OTHER,,,,,,,2023,1.0
NCT04101357,,2019-09-20,,,2024-08-01,2019-09-23,2019-09-24,ACTUAL,,,,,,,2024-08-01,2024-08-02,ACTUAL,2020-06-19,ACTUAL,2020-06-19,2024-08,2024-08-31,2024-05-23,ACTUAL,2024-05-23,2024-01-19,ACTUAL,2024-01-19,,INTERVENTIONAL,,,"Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411","Phase 1/2a, First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT411 as a Monotherapy in Patients With Solid Tumors and in Combination With Atezolizumab, Carboplatin and Etoposide in Patients With Chemotherapy-naïve Extensive-stage Small Cell Lung Cancer (ES-SCLC)",TERMINATED,,PHASE1/PHASE2,55.0,ACTUAL,BioNTech SE,,3.0,,Sponsor decision,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,INDUSTRY,,,,,,,2024,0.0
NCT04276597,,2020-02-14,,,2023-03-09,2020-02-17,2020-02-19,ACTUAL,,,,,,,2023-03-09,2023-03-10,ACTUAL,2020-03-04,ACTUAL,2020-03-04,2023-03,2023-03-31,2021-07-15,ACTUAL,2021-07-15,2021-07-15,ACTUAL,2021-07-15,,INTERVENTIONAL,PUTNET,,"Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET), or Any Other Non-.GEP-NET.","A Phase II, Non-Randomized, Open-Label, Single-center, Physician Sponsored Study to Determine the Safety and Effectiveness of Lu-177 DOTATOC in Adult Subjects With Somatostatin Receptor Expressing Pulmonary, Pheochromocytoma, paragangliomUnknown Primary, and Thymus Neuroendocrine Tumors (PUTNET) or Any Other Non-.GEP-NET.",WITHDRAWN,,PHASE2,0.0,ACTUAL,Excel Diagnostics and Nuclear Oncology Center,,1.0,,No subjects were eligible for the study. The study closed on 07-15-2021.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,OTHER,,,,,,,2021,0.0
NCT02985554,,2016-12-01,,,2020-06-24,2016-12-02,2016-12-07,ESTIMATED,,,,,,,2020-06-24,2020-06-25,ACTUAL,2017-03-20,ACTUAL,2017-03-20,2020-06,2020-06-30,2020-06-22,ACTUAL,2020-06-22,2019-02-06,ACTUAL,2019-02-06,,INTERVENTIONAL,,,Phase I Study to Assess the Tolerability and Efficacy of Nivolumab in Patients With Hematologic Malignancies,Phase I Study to Assess the Tolerability and Efficacy of Nivolumab as Single Agent to Eliminate Minimal Residual Disease and Maintain Remission in Patients With Hematologic Malignancies After Allogeneic Stem Cell Transplantation,TERMINATED,,PHASE1,3.0,ACTUAL,University of Chicago,,1.0,,Study stopped early due to slow accrual and safety concerns.,f,,,,,t,f,,,,,,,,,,,2024-10-15 09:49:54.885742,2024-10-15 09:49:54.885742,OTHER,,,,,,,2020,0.0
NCT03988114,,2019-06-12,,,2019-09-04,2019-06-12,2019-06-17,ACTUAL,,,,,,,2019-09-04,2019-09-06,ACTUAL,2019-09-16,ESTIMATED,2019-09-16,2019-09,2019-09-30,2023-03-23,ESTIMATED,2023-03-23,2022-03-23,ESTIMATED,2022-03-23,,INTERVENTIONAL,proMONARCH,,"A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer","A Single-Arm, Global, Phase 4 Study of Abemaciclib, a CDK 4 & 6 Inhibitor, in Combination With Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer With Poor Prognostic Factors",WITHDRAWN,,PHASE4,0.0,ACTUAL,Eli Lilly and Company,,1.0,,"Strategic decision due to emerging new data for patients with HR+, HER2- metastatic breast cancer.",t,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://www.clinicalstudydatarequest.com,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,INDUSTRY,,NCT03763604,AVAILABLE,,,,2023,0.0
NCT02564536,,2015-09-29,,,2017-05-03,2015-09-29,2015-09-30,ESTIMATED,,,,,,,2017-05-03,2017-05-08,ACTUAL,2017-06,ESTIMATED,2017-06-30,2017-05,2017-05-31,2020-06-30,ESTIMATED,2020-06-30,2020-06-30,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,Pacritinib in Combination With Low Dose Decitabine in Intermediate-High Risk Myelofibrosis or Myeloproliferative Neoplasm (MPN)/Myelodysplastic Syndrome (MDS),A Pilot Study of Pacritinib in Combination With Low Dose Decitabine in Patients With Intermediate-High Risk Myelofibrosis or MPN/MDS Syndromes,WITHDRAWN,,PHASE1,0.0,ACTUAL,Washington University School of Medicine,,1.0,,Lack of funding following full FDA clinical hold,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,OTHER,,,,,,,2020,0.0
NCT04541550,,2020-09-01,,,2021-09-01,2020-09-01,2020-09-09,ACTUAL,,,,,,,2021-09-01,2021-09-08,ACTUAL,2021-04-01,ESTIMATED,2021-04-01,2021-09,2021-09-30,2021-07-01,ESTIMATED,2021-07-01,2021-07-01,ESTIMATED,2021-07-01,,INTERVENTIONAL,,,Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa,"An Open-label, Dose-escalation Study to Evaluate the Use of Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa",WITHDRAWN,,PHASE1,0.0,ACTUAL,"IntegoGen, LLC",,3.0,,Study didn't proceed to FDA submission,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,INDUSTRY,,,,,,,2021,0.0
NCT03107325,,2017-03-30,,,2020-10-04,2017-04-04,2017-04-11,ACTUAL,,,,,,,2020-10-04,2020-10-06,ACTUAL,2019-02-01,ACTUAL,2019-02-01,2020-10,2020-10-31,2020-10-01,ACTUAL,2020-10-01,2020-10-01,ACTUAL,2020-10-01,,INTERVENTIONAL,,,Biokinetics Study for F-18 FDG in Pediatric Molecular Imaging,Biokinetics Study for F-18 FDG for Dose Reduction in Pediatric Molecular Imaging,WITHDRAWN,,PHASE4,0.0,ACTUAL,Boston Children's Hospital,,1.0,,No subjects who met the study criteria agreed to participate in two years prior to the COVID-19 crisis.,f,,,,f,t,f,,,t,,,,,,YES,"Anonymized patient data, with all protected patient information removed, will be shared with collaborators at Johns Hopkins University and the University of Florida. In particular, anonymized nuclear medicine image data will be shared for analysis.",2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,OTHER,,,,,,,2020,0.0
NCT05263505,,2022-02-16,2023-09-19,,2023-10-31,2022-02-21,2022-03-02,ACTUAL,2023-10-31,2023-11-07,ACTUAL,,,,2023-10-31,2023-11-07,ACTUAL,2022-02-21,ACTUAL,2022-02-21,2023-10,2023-10-31,2023-09-11,ACTUAL,2023-09-11,2023-09-11,ACTUAL,2023-09-11,,INTERVENTIONAL,,,Baricitinib for the Treatment of Ocular Mucous Membrane Pemphigoid,Baricitinib for the Treatment of Ocular Mucous Membrane Pemphigoid,TERMINATED,,PHASE2,2.0,ACTUAL,Washington University School of Medicine,,2.0,,Sponsor,f,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-16 16:49:47.467574,2024-10-16 16:49:47.467574,OTHER,,,,,,,2023,0.0
NCT01657604,,2012-07-09,,,2023-05-09,2012-08-03,2012-08-06,ESTIMATED,,,,,,,2023-05-09,2023-05-10,ACTUAL,2012-08-24,ACTUAL,2012-08-24,2023-05,2023-05-31,2022-05-31,ACTUAL,2022-05-31,2022-05-31,ACTUAL,2022-05-31,,INTERVENTIONAL,TIGER,,TKI and Interferon Alpha Evaluation Initiated by the German Chronic Myeloid Leukemia Study Group - the TIGER Study,Treatment Optimization of Newly Diagnosed Ph/BCR-ABL Positive Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase With Nilotinib vs. Nilotinib Plus Interferon Alpha Induction and Nilotinib or Interferon Alpha Maintenance Therapy,COMPLETED,,PHASE3,717.0,ACTUAL,University of Jena,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,OTHER,,,,,,,2022,0.0
NCT03094169,,2017-02-06,,,2021-03-22,2017-03-22,2017-03-29,ACTUAL,,,,,,,2021-03-22,2021-03-24,ACTUAL,2017-02-01,ACTUAL,2017-02-01,2021-03,2021-03-31,2021-01-30,ACTUAL,2021-01-30,2020-11-28,ACTUAL,2020-11-28,,INTERVENTIONAL,,,AVID100 in Advanced Epithelial Carcinomas,"Phase 1a/2a Dose Escalation Trial to Determine Safety, Tolerance, MTD, and Preliminary Antineoplastic Activity of AVID100, in Patients With Advanced or Metastatic Solid Tumors of Epithelial Origin",TERMINATED,,PHASE1/PHASE2,49.0,ACTUAL,Formation Biologics,,4.0,,lack of efficacy,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,INDUSTRY,,,,,,,2021,0.0
NCT03428945,,2018-01-24,2023-12-14,,2024-03-13,2018-02-08,2018-02-12,ACTUAL,2024-03-13,2024-04-09,ACTUAL,,,,2024-03-13,2024-04-09,ACTUAL,2018-08-15,ACTUAL,2018-08-15,2023-07,2023-07-31,2022-10-31,ACTUAL,2022-10-31,2022-10-27,ACTUAL,2022-10-27,,INTERVENTIONAL,TN-22,,Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus,Hydroxychloroquine for Prevention of Abnormal Glucose Tolerance and Diabetes in Individuals At-risk for Type 1 Diabetes Mellitus (T1D),TERMINATED,,PHASE2,273.0,ACTUAL,National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),Interim analysis completed prompted the DSMB's decision to terminate the protocol early limiting the originally planned follow up period for participants.,2.0,,This trial has undergone a prespecified interim analysis which determined that this treatment provides no statistically significant delay in the onset of abnormal glucose tolerance or Type 1 Diabetes.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 16:49:47.467574,2024-10-16 16:49:47.467574,NIH,,,,,,,2022,0.0
NCT03827200,,2019-01-25,,,2021-02-23,2019-01-31,2019-02-01,ACTUAL,,,,,,,2021-02-23,2021-02-26,ACTUAL,2019-04-11,ACTUAL,2019-04-11,2021-02,2021-02-28,2021-01-21,ACTUAL,2021-01-21,2020-12-29,ACTUAL,2020-12-29,,INTERVENTIONAL,,,A Study Evaluating the Utility of Ambrisentan in Lowering Portal Pressure in Patients With Liver Cirrhosis,"A Phase II, Single-arm, Open-label Study to Characterise the Effect on Portal Pressure, the Effect on Renal Function and the Pharmacokinetic Profile of N-003 in Patients With Decompensated Cirrhosis",TERMINATED,,PHASE2,19.0,ACTUAL,Noorik Biopharmaceuticals AG,,1.0,,"Lack of recruitment, result of COVID-19 pandemic",f,,,,f,f,f,,,f,,,,,,,,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,INDUSTRY,,,,,,,2021,0.0
NCT03843125,,2019-02-14,2023-03-30,,2023-05-12,2019-02-14,2019-02-15,ACTUAL,2023-05-12,2023-05-16,ACTUAL,,,,2023-05-12,2023-05-16,ACTUAL,2019-09-09,ACTUAL,2019-09-09,2023-05,2023-05-31,2022-04-01,ACTUAL,2022-04-01,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,SLE-BRAVE-X,All randomized participants.,A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE),"A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)",TERMINATED,,PHASE3,1147.0,ACTUAL,Eli Lilly and Company,This study was terminated due to insufficient evidence to support a positive benefit: risk profile. Safety findings were consistent with previously published OLUMIANT data.,4.0,,Study terminated due to insufficient evidence to support a positive benefit: risk profile. Safety findings were consistent with previously published OLUMIANT data,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,INDUSTRY,,,,,,,2022,0.0
NCT04840615,,2021-04-09,2023-12-18,,2024-01-09,2021-04-09,2021-04-12,ACTUAL,2024-01-09,2024-02-02,ACTUAL,,,,2024-01-09,2024-02-02,ACTUAL,2021-06-11,ACTUAL,2021-06-11,2024-01,2024-01-31,2022-01-12,ACTUAL,2022-01-12,2021-12-06,ACTUAL,2021-12-06,,INTERVENTIONAL,,,Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma,Phase I Study of Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma,TERMINATED,,PHASE1,2.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,Study was closed early due to slow accrual.,f,,,,t,t,f,,,,,,Clinical data in Biomedical Translational Research Information System (BTRIS) will be shared throughout the course of the study and indefinitely with the permission of the investigator.,"Clinical individual participant data (IPD) will be shared through the Biomedical Translational Research Information System (BTRIS) database for open-ended analysis. All BTRIS subscribers, generally limited to the National Institutes of Health (NIH) Clinical Center, may request data.",,YES,All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,NIH,,,,,,,2022,0.0
NCT02476409,,2015-06-12,2022-03-24,,2022-05-03,2015-06-16,2015-06-19,ESTIMATED,2022-05-03,2022-05-05,ACTUAL,,,,2022-05-03,2022-05-05,ACTUAL,2015-07,,2015-07-31,2022-04,2022-04-30,2021-05-13,ACTUAL,2021-05-13,2021-05-13,ACTUAL,2021-05-13,,INTERVENTIONAL,TROUPER,,Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying Responders,Tolvaptan Treatment to Reverse Worsening Outpatient Heart Failure: Possible Role of Copeptin In Identifying Responders (TROUPER),COMPLETED,,PHASE4,40.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,OTHER,,,,,,,2021,1.0
NCT03266081,,2017-08-22,,,2022-08-23,2017-08-28,2017-08-29,ACTUAL,,,,,,,2022-08-23,2022-08-25,ACTUAL,2015-04,ACTUAL,2015-04-30,2022-08,2022-08-31,2022-08-23,ACTUAL,2022-08-23,2022-08-23,ACTUAL,2022-08-23,,INTERVENTIONAL,,,Bupivacaine Epiphora Trial,Improving Epiphora & Ptosis With Bupivacaine,WITHDRAWN,,PHASE2,0.0,ACTUAL,McMaster University,,1.0,,No patients,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,OTHER,,,,,,,2022,0.0
NCT02959944,,2016-10-25,2021-03-11,,2023-03-28,2016-11-07,2016-11-09,ESTIMATED,2021-04-08,2021-05-04,ACTUAL,,,,2023-03-28,2023-03-30,ACTUAL,2017-05-11,ACTUAL,2017-05-11,2023-03,2023-03-31,2021-07-12,ACTUAL,2021-07-12,2020-03-27,ACTUAL,2020-03-27,,INTERVENTIONAL,iNTEGRATE,,Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD),"A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD)",COMPLETED,,PHASE3,193.0,ACTUAL,Pharmacyclics LLC.,,2.0,,,f,,,,,t,f,,,,,,,,http://yoda.yale.edu,YES,"Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.",2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,INDUSTRY,,,,,,,2021,1.0
NCT05111002,,2021-10-27,2024-09-23,,2024-09-23,2021-10-27,2021-11-08,ACTUAL,2024-09-23,2024-10-16,ESTIMATED,,,,2024-09-23,2024-10-16,ESTIMATED,2022-04-22,ACTUAL,2022-04-22,2024-09,2024-09-30,2023-11-30,ACTUAL,2023-11-30,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,,,Lefamulin for M. Genitalium Treatment Failures,Lefamulin for Mycoplasma Genitalium Treatment Failures in the US,TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,University of Washington,This trial was stopped early due to cessation of operations by the antibiotic manufacturer and expiration of study drug. The number of study participants was less than designed and the small number of people resulted in unstable efficacy estimates and wide 95% confidence intervals.,2.0,,At Sponsor Request,,,,,f,t,f,,,f,,,,,,NO,Not federally funded. Currently no IPD sharing plan.,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,OTHER,,,,,,,2023,0.0
NCT06124144,,2023-08-31,,,2024-03-07,2023-11-08,2023-11-09,ACTUAL,,,,,,,2024-03-07,2024-03-12,ACTUAL,2023-06-21,ACTUAL,2023-06-21,2023-06,2023-06-30,2024-02-27,ACTUAL,2024-02-27,2024-02-27,ACTUAL,2024-02-27,,INTERVENTIONAL,,,Safety and Drug Absorption of Orally Administered Oleylphosphocholine (OlPC) in Healthy Adults,"Safety and Pharmacokinetics of Oleylphosphocholine (OlPC), Administered Orally in Healthy Adults: A Phase 1, Single Center, Open-label, Staggered, Dose-escalation Trial",TERMINATED,,PHASE1,13.0,ACTUAL,University Hospital Tuebingen,,1.0,,The risk-benefit ratio changed,f,,,,t,f,f,,,,,,,,,,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,OTHER,,,,,,,2024,0.0
NCT01970410,,2013-10-22,2022-08-10,,2023-01-26,2013-10-22,2013-10-28,ESTIMATED,2022-09-21,2022-10-20,ACTUAL,,,,2023-01-26,2023-01-30,ACTUAL,2013-10,,2013-10-31,2023-01,2023-01-31,2022-02-14,ACTUAL,2022-02-14,2021-04-30,ACTUAL,2021-04-30,,INTERVENTIONAL,,Main study participants.,MAIN STUDY: SWITCH SUB-STUDY: SWITCH-JCV,MAIN STUDY: Switching Relapsing Multiple Sclerosis Patients Treated With Natalizumab at Risk for Progressive Multifocal Leukoencephalopathy to Teriflunomide: Is This Safe and Effective? SUB-STUDY: Analysis of JCV Antibody Index in MS Patients Treated With Teriflunomide,COMPLETED,,PHASE4,55.0,ACTUAL,Providence Health & Services,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,OTHER,,,,,,,2022,1.0
NCT03579160,,2018-06-07,,,2022-01-10,2018-06-29,2018-07-06,ACTUAL,,,,,,,2022-01-10,2022-01-25,ACTUAL,2019-01-02,ACTUAL,2019-01-02,2022-01,2022-01-31,2022-01-10,ACTUAL,2022-01-10,2022-01-10,ACTUAL,2022-01-10,,INTERVENTIONAL,FTSG,,Efficacy and Safety of 0.25% Timolol Gel in Enhancing Full Thickness Skin Grafts Healing and Cosmetic Outcomes,"Efficacy and Safety of 0.25% Timolol Gel in Enhancing Full Thickness Skin Grafts Healing and Cosmetic Outcomes: A Randomized, Controlled Trial",TERMINATED,,PHASE2/PHASE3,10.0,ACTUAL,Brigham and Women's Hospital,,2.0,,Due to the insufficient accrual rate and strategic reasons to focus our efforts on higher impact research projects.,f,,,,f,t,f,,,t,,,,,,UNDECIDED,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,OTHER,,,,,,,2022,0.0
NCT04128176,,2019-10-12,,,2024-07-01,2019-10-15,2019-10-16,ACTUAL,,,,,,,2024-07-01,2024-07-03,ACTUAL,2017-03,ESTIMATED,2017-03-31,2024-07,2024-07-31,2023-11-25,ESTIMATED,2023-11-25,2023-05-25,ESTIMATED,2023-05-25,,INTERVENTIONAL,,,Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid,An Open-Label Study to Evaluate the Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid,WITHDRAWN,,PHASE3,0.0,ACTUAL,"University of California, Davis",,1.0,,PI did not pursue this study; this study was not IRB-approved and never started.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,OTHER,,,,,,,2023,0.0
NCT03189719,,2017-06-14,2021-05-18,,2024-10-10,2017-06-15,2017-06-16,ACTUAL,2021-06-14,2021-07-06,ACTUAL,,,,2024-10-10,2024-10-15,ACTUAL,2017-07-25,ACTUAL,2017-07-25,2024-10,2024-10-31,2023-07-10,ACTUAL,2023-07-10,2020-07-02,ACTUAL,2020-07-02,,INTERVENTIONAL,,,First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590),"A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination With Cisplatin and 5-Fluorouracil Versus Placebo in Combination With Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects With Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)",COMPLETED,,PHASE3,749.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,INDUSTRY,,,,,,,2023,1.0
NCT03451825,,2018-02-26,2022-05-25,,2024-01-15,2018-02-26,2018-03-02,ACTUAL,2024-01-15,2024-06-24,ACTUAL,,,,2024-01-15,2024-06-24,ACTUAL,2018-03-07,ACTUAL,2018-03-07,2024-01,2024-01-31,2021-07-27,ACTUAL,2021-07-27,2021-07-27,ACTUAL,2021-07-27,,INTERVENTIONAL,,Full analysis set included all participants who had received any dose of avelumab.,Phase I/II Study of Avelumab in Pediatric Cancer Participants,"Open-label, Phase I/II Study to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Anticancer Activity of Avelumab in Pediatric Subjects From Birth to Less Than 18 Years of Age With Refractory or Relapsed Solid Tumors and Lymphoma",TERMINATED,,PHASE1,21.0,ACTUAL,EMD Serono,"The study was planned to be conducted in 2 parts: the dose-finding part (Phase I) and the tumor-specified expansion part (Phase II). However, Phase II was cancelled due to limited clinical benefit of PD-L1 monotherapy in pediatric participants.",2.0,,"Based on the limited activity observed with avelumab monotherapy in the pediatric population, the Phase II study part was cancelled.",f,,,,f,t,f,,,,,,,,,,,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,INDUSTRY,,,,,,,2021,0.0
NCT03487276,,2018-02-27,2021-01-18,,2021-03-15,2018-03-27,2018-04-04,ACTUAL,2021-03-15,2021-04-08,ACTUAL,,,,2021-03-15,2021-04-08,ACTUAL,2018-02-26,ACTUAL,2018-02-26,2021-03,2021-03-31,2020-01-27,ACTUAL,2020-01-27,2019-05-27,ACTUAL,2019-05-27,,INTERVENTIONAL,SHINE,Baseline analysis performed for safety analysis set (SAS),Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS),"A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Determine Efficacy and Safety of IFX-1 in Subjects With Moderate to Severe Hidradenitis Suppurativa",COMPLETED,,PHASE2,179.0,ACTUAL,InflaRx GmbH,,5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,INDUSTRY,,,,,,,2020,0.0
NCT05152849,,2021-11-29,,,2022-10-18,2021-11-29,2021-12-10,ACTUAL,,,,,,,2022-10-18,2022-10-20,ACTUAL,2021-12-15,ACTUAL,2021-12-15,2021-11,2021-11-30,2022-06-29,ACTUAL,2022-06-29,2022-06-21,ACTUAL,2022-06-21,,INTERVENTIONAL,,,"Efficacy, Safety, Tolerability of AXA1125 in Fatigue After COVID-19 Infection","A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of AXA1125 in Subjects With Fatigue-Predominant Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection",COMPLETED,,PHASE2,41.0,ACTUAL,"Axcella Health, Inc",,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,INDUSTRY,,,,,,,2022,0.0
NCT04049097,,2019-04-01,2023-05-15,,2023-08-22,2019-08-06,2019-08-07,ACTUAL,2023-08-22,2023-09-15,ACTUAL,,,,2023-08-22,2023-09-15,ACTUAL,2019-05-20,ACTUAL,2019-05-20,2023-08,2023-08-31,2021-11-15,ACTUAL,2021-11-15,2021-11-15,ACTUAL,2021-11-15,,INTERVENTIONAL,,Safety population: All patients who received at least 1 dose or partial dose of arimoclomol in IBM-OLE.,Arimoclomol in Sporadic Inclusion Body Myositis - Open Label Extension Trial,"An Open-label, Non-randomized Trial to Investigate the Efficacy and Safety of Early Versus Delayed Start of Arimoclomol in Patients With Sporadic Inclusion Body Myositis Who Have Completed the IBM4809 Trial",TERMINATED,,PHASE3,121.0,ACTUAL,ZevraDenmark,,1.0,,"As a consequence of the results of IBM4809 which did not meet any of its efficacy endpoints. The planned duration of open-label treatment was 40 months. After termination, the actual mean duration of treatment was approx. 28 weeks.",f,,,,f,t,f,,,,,,,,,,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2021,0.0
NCT03396471,,2017-12-27,2022-10-20,,2024-04-16,2018-01-09,2018-01-11,ACTUAL,2022-12-02,2022-12-23,ACTUAL,,,,2024-04-16,2024-04-18,ACTUAL,2018-02-01,ACTUAL,2018-02-01,2024-04,2024-04-30,2023-03-02,ACTUAL,2023-03-02,2021-08-12,ACTUAL,2021-08-12,,INTERVENTIONAL,,,Study of Pembrolizumab and Concurrent Radiation in Patients With Previously Treated Carcinoma of Unknown Primary,Single-arm Phase 2 Study to Examine Pembrolizumab and Concurrent Radiation to Induce an Abscopal Effect in Patients With Previously Treated Carcinoma of Unknown Primary (CUP16-268),TERMINATED,,PHASE2,14.0,ACTUAL,Hoosier Cancer Research Network,,1.0,,Study failed to meet its interim analysis endpoint,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,OTHER,,,,,,,2023,0.0
NCT03510884,,2018-04-18,2023-01-09,2022-01-12,2023-04-12,2018-04-18,2018-04-27,ACTUAL,2023-04-12,2023-05-06,ACTUAL,,2023-05-06,ACTUAL,2023-04-12,2023-05-06,ACTUAL,2018-05-31,ACTUAL,2018-05-31,2023-04,2023-04-30,2022-08-05,ACTUAL,2022-08-05,2021-01-14,ACTUAL,2021-01-14,,INTERVENTIONAL,,Analysis was performed on all randomized participants.,An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia,"A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label Treatment Period to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia",COMPLETED,,PHASE3,153.0,ACTUAL,Sanofi,,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,INDUSTRY,,,,,,,2022,1.0
NCT04626297,,2020-11-06,2023-08-02,,2023-10-04,2020-11-06,2020-11-12,ACTUAL,2023-08-02,2023-08-28,ACTUAL,,,,2023-10-04,2023-10-17,ACTUAL,2020-11-17,ACTUAL,2020-11-17,2023-10,2023-10-31,2022-09-30,ACTUAL,2022-09-30,2022-08-03,ACTUAL,2022-08-03,,INTERVENTIONAL,,All randomized participants.,A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA),"A Phase 3, 16-week, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Assess the Impact of Lebrikizumab on Vaccine Responses in Adult Patients With Moderate-to-Severe Atopic Dermatitis",COMPLETED,,PHASE3,254.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,INDUSTRY,,,,,,,2022,0.0
NCT03913130,,2019-02-21,2022-11-10,,2024-10-03,2019-04-10,2019-04-12,ACTUAL,2022-12-09,2023-01-04,ACTUAL,,,,2024-10-03,2024-10-15,ACTUAL,2019-05-13,ACTUAL,2019-05-13,2024-10,2024-10-31,2022-10-03,ACTUAL,2022-10-03,2022-10-03,ACTUAL,2022-10-03,,INTERVENTIONAL,INSIGHT,,Extension Study to Study PQ-110-001 (NCT03140969),"An Open-Label, Extension Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of QR-110 in Subjects With Leber's Congenital Amaurosis (LCA) Due to the c.2991+1655A>G Mutation (p.Cys998X) in the CEP290 Gene",TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,Laboratoires Thea,,1.0,,Terminated \[Study prematurely terminated due to sponsor decision for reasons unrelated to safety\],f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,INDUSTRY,,,,,,,2022,0.0
NCT02076672,,2014-02-24,,,2021-07-12,2014-02-26,2014-03-03,ESTIMATED,,,,,,,2021-07-12,2021-07-13,ACTUAL,2019-11-05,ACTUAL,2019-11-05,2021-07,2021-07-31,2020-04-28,ACTUAL,2020-04-28,2020-04-28,ACTUAL,2020-04-28,,INTERVENTIONAL,ABOCA1,,Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population,Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population (The ABOCA Phase II Trial),COMPLETED,,PHASE2,3.0,ACTUAL,Ontario Clinical Oncology Group (OCOG),,1.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,OTHER,,,,,,,2020,0.0
NCT02426086,,2015-04-21,2021-04-02,2019-04-04,2021-08-17,2015-04-21,2015-04-24,ESTIMATED,2021-08-17,2021-09-14,ACTUAL,2019-05-24,2019-06-03,ACTUAL,2021-08-17,2021-09-14,ACTUAL,2015-08-28,ACTUAL,2015-08-28,2021-08,2021-08-31,2020-02-07,ACTUAL,2020-02-07,2018-04-26,ACTUAL,2018-04-26,,INTERVENTIONAL,,Intent-to-Treat (ITT) analysis set included all participants randomized into the study and classified according to their assigned treatment group.,Study to Evaluate Activity of 2 Dose Levels of Imetelstat in Participants With Intermediate-2 or High-Risk Myelofibrosis (MF) Previously Treated With Janus Kinase (JAK) Inhibitor,"A Randomized, Single-Blind, Multicenter Phase 2 Study to Evaluate the Activity of 2 Dose Levels of Imetelstat in Subjects With Intermediate-2 or High-Risk Myelofibrosis (MF) Relapsed/Refractory to Janus Kinase (JAK) Inhibitor",COMPLETED,,PHASE2,107.0,ACTUAL,Geron Corporation,,2.0,,,f,,,,f,t,,,,,,,,,,,,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,INDUSTRY,,,,,,,2020,1.0
NCT03454893,,2017-12-20,2023-09-25,2022-11-15,2024-01-03,2018-02-27,2018-03-06,ACTUAL,2024-01-03,2024-01-05,ACTUAL,,2024-01-05,ACTUAL,2024-01-03,2024-01-05,ACTUAL,2018-02-21,ACTUAL,2018-02-21,2023-09,2023-09-30,2022-03-14,ACTUAL,2022-03-14,2022-03-14,ACTUAL,2022-03-14,,INTERVENTIONAL,,Safety population consists of all enrolled subjects who received any preparatory medication.,"Open Label, Study Of Efficacy and Safety Of AVR-RD-01 for Treatment-Naive Subjects With Classic Fabry Disease","An Open-Label, Multinational Study Of The Efficacy And Safety of Ex Vivo, Lentiviral Vector-Mediated Gene Therapy AVR-RD-01 For Treatment-Naive Subjects With Classic Fabry Disease",TERMINATED,,PHASE1/PHASE2,15.0,ACTUAL,AVROBIO,"SF-36 data at W24 was inadvertently not collected due to omission in the Protocol Schedule of Assessments.~Invasive sampling, such as bone marrow aspirate, was only provided by one subject at Week 48.~Central laboratory only reported albumin levels in urine and not urine total protein data.",1.0,,AVROBIO has deprioritized its Fabry disease program,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,INDUSTRY,,,,,,,2022,0.0
NCT02990091,,2016-12-05,,,2022-10-10,2016-12-07,2016-12-12,ESTIMATED,,,,,,,2022-10-10,2022-10-13,ACTUAL,2017-01,,2017-01-31,2022-10,2022-10-31,2023-12,ESTIMATED,2023-12-31,2023-01,ESTIMATED,2023-01-31,,INTERVENTIONAL,,,Derivatives of Omega-3 HUFA as Biomarkers of Traumatic Brain Injury,Traumatic Brain Injury Recovery With n-3 Highly Unsaturated Fatty Acids (HUFAs): A Biomarker-driven Approach,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Pennsylvania,,4.0,,Unable to recruit participants,f,,,,f,,,,,,,,,,,NO,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,OTHER,,,,,,,2023,0.0
NCT02853578,,2016-07-25,,,2019-07-03,2016-07-29,2016-08-03,ESTIMATED,,,,,,,2019-07-03,2019-07-08,ACTUAL,2019-12,ESTIMATED,2019-12-31,2019-07,2019-07-31,2020-12,ESTIMATED,2020-12-31,2020-10,ESTIMATED,2020-10-31,,INTERVENTIONAL,Laennec,,Busonid® (Budesonide 200 mcg and 400 mcg) to Treat Asthma Not Controlled or Partially Controlled,"National Clinical Study, Multicentric, Single Arm to Evaluate the Efficacy and Safety of Busonid® (Budesonide 200 mcg and 400 mcg) to Treat Asthma Not Controlled or Partially Controlled",SUSPENDED,,PHASE3,80.0,ESTIMATED,Ache Laboratorios Farmaceuticos S.A.,,1.0,,The viability of the study is being analyzed,f,,,,f,f,f,,,f,,,,,,,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,INDUSTRY,,,,,,,2020,0.0
NCT01062399,,2010-02-03,2017-11-13,,2022-05-23,2010-02-03,2010-02-04,ESTIMATED,2017-12-19,2018-01-23,ACTUAL,,,,2022-05-23,2022-06-09,ACTUAL,2010-12,,2010-12-31,2022-05,2022-05-31,2022-05-20,ACTUAL,2022-05-20,2016-06,ACTUAL,2016-06-30,,INTERVENTIONAL,RTOG 0913,Eligible randomized patients,"Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme",Phase I/II Trial of Concurrent RAD001 (Everolimus) With Temozolomide/Radiation Followed by Adjuvant RAD001/Temozolomide in Newly Diagnosed Glioblastoma,COMPLETED,,PHASE1/PHASE2,279.0,ACTUAL,Radiation Therapy Oncology Group,,5.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,NETWORK,,,,,,,2022,1.0
NCT04590781,,2020-10-05,2023-02-23,,2023-03-30,2020-10-15,2020-10-19,ACTUAL,2023-03-30,2023-04-20,ACTUAL,,,,2023-03-30,2023-04-20,ACTUAL,2021-05-10,ACTUAL,2021-05-10,2023-03,2023-03-31,2022-03-24,ACTUAL,2022-03-24,2022-03-24,ACTUAL,2022-03-24,,INTERVENTIONAL,,All participants who received at least 1 dose of XmAb18087.,Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer,A Phase 1b/2 Multiple-Dose Study to Evaluate the Safety and Efficacy of XmAb18087 ± Pembrolizumab in Subjects With Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer (DUET-1-02) Protocol,TERMINATED,,PHASE1/PHASE2,4.0,ACTUAL,"Xencor, Inc.","Study was terminated by the sponsor and only 2 participants each were enrolled in Parts A and C. No participants were enrolled for Part B. Data were not collected for the prespecified analyses of efficacy, pharmacokinetics, and immunogenicity outcome measures.",3.0,,The study has been terminated early by the sponsor due to business decision.,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,INDUSTRY,,,,,,,2022,0.0
NCT02748798,,2016-04-19,,,2024-10-08,2016-04-19,2016-04-22,ESTIMATED,,,,,,,2024-10-08,2024-10-15,ACTUAL,2020-11-10,ACTUAL,2020-11-10,2024-10,2024-10-31,2021-10-16,ACTUAL,2021-10-16,2021-10-16,ACTUAL,2021-10-16,,INTERVENTIONAL,,,Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders,Developing Optimal Parameters for Hyperpolarized Noble Gas (3He and 129Xe) and Inert Fluorinated Gas Magnetic Resonance Imaging of Lung Disorders,TERMINATED,,EARLY_PHASE1,10.0,ACTUAL,Thunder Bay Regional Health Research Institute,,2.0,,Funding is no longer available due to the failure to enroll the target number of participants within the required timeframe.,f,,,,f,f,f,,,,,,,,,,,2024-10-17 04:26:52.048975,2024-10-17 04:26:52.048975,OTHER,,,,,,,2021,0.0
NCT03573336,,2018-06-19,2020-12-21,2020-03-17,2022-04-13,2018-06-19,2018-06-29,ACTUAL,2021-01-19,2021-01-22,ACTUAL,2021-01-19,2021-01-22,ACTUAL,2022-04-13,2022-05-04,ACTUAL,2018-07-04,ACTUAL,2018-07-04,2022-04,2022-04-30,2020-11-26,ACTUAL,2020-11-26,2019-03-18,ACTUAL,2019-03-18,,INTERVENTIONAL,VILLENDO,,Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis,"A Randomized, Double-blind, Parallel-group, Multicenter Phase 2b Study to Assess the Efficacy and Safety of Two Different Doses of Vilaprisan (BAY1002670) Versus Placebo in Women With Symptomatic Endometriosis",TERMINATED,,PHASE2,8.0,ACTUAL,Bayer,No inferential statistical analysis was performed due to a small population.,3.0,,"Due to a change in the development program, the study was closed prematurely.",f,,,,f,t,f,,,f,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2020,0.0
NCT04541173,,2020-09-01,2024-05-06,,2024-06-04,2020-09-01,2020-09-09,ACTUAL,2024-06-04,2024-06-05,ACTUAL,,,,2024-06-04,2024-06-05,ACTUAL,2020-11-30,ACTUAL,2020-11-30,2024-06,2024-06-30,2023-06-30,ACTUAL,2023-06-30,2023-06-18,ACTUAL,2023-06-18,,INTERVENTIONAL,,,Study of Atezolizumab and Bevacizumab With Y-90 TARE in Patients With Unresectable Hepatocellular Carcinoma (HCC),A Randomized Phase II Study of Atezolizumab and Bevacizumab With Y-90 TARE in Patients With Unresectable Hepatocellular Carcinoma (HCC),TERMINATED,,PHASE2,6.0,ACTUAL,Hoosier Cancer Research Network,,2.0,,Due to slow accrual.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,OTHER,,,,,,,2023,0.0
NCT04756531,,2021-02-11,2023-04-21,,2024-07-11,2021-02-11,2021-02-16,ACTUAL,2024-07-11,2024-10-15,ACTUAL,,,,2024-07-11,2024-10-15,ACTUAL,2021-02-11,ACTUAL,2021-02-11,2024-07,2024-07-31,2021-09-01,ACTUAL,2021-09-01,2021-09-01,ACTUAL,2021-09-01,,INTERVENTIONAL,,The baseline analysis population included all participants enrolled in the study.,STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS,"A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, SINGLE- AND MULTIPLE-DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF 07321332 IN HEALTHY ADULT PARTICIPANTS",COMPLETED,,PHASE1,70.0,ACTUAL,Pfizer,,6.0,,,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 04:29:36.018885,2024-10-17 04:29:36.018885,INDUSTRY,,,,,,,2021,1.0
NCT03942211,,2019-05-07,2024-04-16,,2024-04-16,2019-05-07,2019-05-08,ACTUAL,2024-04-16,2024-05-08,ACTUAL,,,,2024-04-16,2024-05-08,ACTUAL,2021-02-26,ACTUAL,2021-02-26,2024-04,2024-04-30,2023-04-19,ACTUAL,2023-04-19,2023-04-19,ACTUAL,2023-04-19,,INTERVENTIONAL,SPHINX,,A Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Participants With Sarcoidosis-Associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag.",TERMINATED,,PHASE2,10.0,ACTUAL,Actelion,All planned efficacy analyses could not be performed due to early termination of study.,2.0,,The sponsor decided to prematurely terminate the study due to the lower-than-expected recruitment rate,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"Actelion is a Janssen pharmaceutical company of Johnson \& Johnson. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials\\transparency.~As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu",2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2023,0.0
NCT03380130,,2017-10-20,,,2020-11-03,2017-12-19,2017-12-20,ACTUAL,,,,,,,2020-11-03,2020-11-04,ACTUAL,2017-09-11,ACTUAL,2017-09-11,2020-11,2020-11-30,2020-11-04,ACTUAL,2020-11-04,2020-03-01,ACTUAL,2020-03-01,,INTERVENTIONAL,NASIR-HCC,,A Study of the Safety and Antitumoral Efficacy of Nivolumab After SIRT for the Treatment of Patients With HCC,"A Multicenter, Open-label, Single-arm Study of the Safety and Antitumoral Efficacy of Nivolumab After SIRT Using SIR-Spheres for the Treatment of Patients With HepatoCellular Carcinoma That Are Candidates for Locoregional Therapies",COMPLETED,,PHASE2,41.0,ACTUAL,"Clinica Universidad de Navarra, Universidad de Navarra",,1.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,OTHER,,,,,,,2020,1.0
NCT05796765,,2023-03-21,,,2024-01-12,2023-03-21,2023-04-04,ACTUAL,,,,,,,2024-01-12,2024-01-17,ACTUAL,2023-03-24,ACTUAL,2023-03-24,2024-01,2024-01-31,2023-12-15,ACTUAL,2023-12-15,2023-12-15,ACTUAL,2023-12-15,,INTERVENTIONAL,,,Phase 2B Micronized DHACM vs. Saline in the Treatment of Knee Osteoarthritis,"A Phase 2B, Prospective, Double-Blind, Randomized Controlled Trial of the Micronized DHACM Injectable Product Compared to Saline Placebo Injection for the Treatment of Osteoarthritis of the Knee",TERMINATED,,PHASE2,43.0,ACTUAL,"MiMedx Group, Inc.",,3.0,,Study discontinued early by Sponsor,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,INDUSTRY,,,,,,,2023,0.0
NCT05371275,,2022-04-26,,,2022-11-03,2022-05-11,2022-05-12,ACTUAL,,,,,,,2022-11-03,2022-11-07,ACTUAL,2022-04-21,ACTUAL,2022-04-21,2022-11,2022-11-30,2022-12,ESTIMATED,2022-12-31,2022-10,ESTIMATED,2022-10-31,,INTERVENTIONAL,CDK6COV,,"Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation","Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation",WITHDRAWN,,PHASE2,0.0,ACTUAL,biotx.ai GmbH,,1.0,,Study was withdrawn due to challenges in patient enrollment,f,,,,t,f,f,,,,,,,,,,,2024-10-15 18:45:19.037036,2024-10-15 18:45:19.037036,INDUSTRY,,,,,,,2022,0.0
NCT04588948,,2020-09-29,,,2022-04-21,2020-10-13,2020-10-19,ACTUAL,,,,,,,2022-04-21,2022-04-28,ACTUAL,2020-12,ESTIMATED,2020-12-31,2022-04,2022-04-30,2021-12,ESTIMATED,2021-12-31,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,DRAW-2,,A Pharmacokinetic stuDy of intRavitreal Aflibercept Injection in Vitrectomized and Non-vitrectomized Eyes With Diabetic Macular Edema,A Pharmacokinetic Study of Intravitreal Aflibercept Injection in Vitrectomized and Non-vitrectomized Eyes With Diabetic Macular Edema,WITHDRAWN,,PHASE2,0.0,ACTUAL,Stanford University,,2.0,,Study did not proceed due to funding issues.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,OTHER,,,,,,,2021,0.0
NCT00819221,,2009-01-07,,,2022-08-25,2009-01-07,2009-01-08,ESTIMATED,,,,,,,2022-08-25,2022-08-30,ACTUAL,2009-01-05,ACTUAL,2009-01-05,2022-02,2022-02-28,2021-12-22,ACTUAL,2021-12-22,2011-11-30,ACTUAL,2011-11-30,,INTERVENTIONAL,,,AZD2281 in Combination With Liposomal Doxorubicin in Advanced Solid Tumours,"A Phase I, Open Label, Multicenter Study to Assess the Safety, Tolerability and Pharmacology of AZD2281 in Combination With Liposomal Doxorubicin (Caelyx®) in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1,44.0,ACTUAL,AstraZeneca,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,INDUSTRY,,,,,,,2021,0.0
NCT03227029,,2017-07-20,2020-12-14,,2022-04-20,2017-07-20,2017-07-24,ACTUAL,2020-12-14,2021-01-08,ACTUAL,,,,2022-04-20,2022-04-22,ACTUAL,2017-09-22,ACTUAL,2017-09-22,2022-04,2022-04-30,2020-10-01,ACTUAL,2020-10-01,2019-12-19,ACTUAL,2019-12-19,,INTERVENTIONAL,,Baseline analysis population was participants who received inoculation and were followed on study past Day 0.,"Evaluating the Infectivity, Safety, and Immunogenicity of Recombinant Live-Attenuated RSV Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants 6 to 24 Months of Age","Randomized Phase I Study of the Infectivity, Safety, and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age",COMPLETED,,PHASE1,65.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,NIH,,,,,,,2020,1.0
NCT02492711,,2015-07-06,2022-04-01,,2022-10-28,2015-07-08,2015-07-09,ESTIMATED,2022-10-28,2022-11-23,ACTUAL,,,,2022-10-28,2022-11-23,ACTUAL,2015-08-24,ACTUAL,2015-08-24,2022-10,2022-10-31,2022-06-14,ACTUAL,2022-06-14,2021-08-11,ACTUAL,2021-08-11,,INTERVENTIONAL,SOPHIA,,Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer,"A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment",COMPLETED,,PHASE3,624.0,ACTUAL,MacroGenics,,3.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,INDUSTRY,,,,,,,2022,1.0
NCT03813979,,2019-01-21,,,2021-06-07,2019-01-21,2019-01-23,ACTUAL,,,,,,,2021-06-07,2021-06-10,ACTUAL,2020-11-15,ESTIMATED,2020-11-15,2021-06,2021-06-30,2021-12-31,ESTIMATED,2021-12-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,POLO,,Pharmacokinetics of Single-dose Dolutegravir in HIV-seronegative Subjects With Severe Hepatic Impairment Compared to Matched Controls.,Pharmacokinetics of Single-dose Dolutegravir in HIV-seronegative Subjects With Severe Hepatic Impairment Compared to Matched Controls.,WITHDRAWN,,PHASE4,0.0,ACTUAL,Radboud University Medical Center,,2.0,,difficult recruitment and delay due to COVID19,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,OTHER,,,,,,,2021,0.0
NCT02664441,,2016-01-04,2021-10-28,,2022-05-04,2016-01-22,2016-01-27,ESTIMATED,2022-05-04,2022-05-05,ACTUAL,,,,2022-05-04,2022-05-05,ACTUAL,2016-03,,2016-03-31,2022-05,2022-05-31,2020-07-31,ACTUAL,2020-07-31,2020-03-16,ACTUAL,2020-03-16,,INTERVENTIONAL,ECHO,,Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity,Glucagon-Like Peptide-1 Agonist Effects on Energy Balance in Hypothalamic Obesity,COMPLETED,,PHASE3,42.0,ACTUAL,Seattle Children's Hospital,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,OTHER,,,,,,,2020,1.0
NCT03998033,,2019-06-07,,,2022-08-19,2019-06-24,2019-06-25,ACTUAL,,,,,,,2022-08-19,2022-08-23,ACTUAL,2019-05-30,ACTUAL,2019-05-30,2022-08,2022-08-31,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,ET-109,,Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma,"An Open-Label, Dose Escalation, Multi-Center Phase I/II Research Trial to Assess the Safety of ET140202 T Cells and Determine the Recommended Phase II Dose (RP2D) in Adults With Advanced Hepatocellular Carcinoma (HCC)",TERMINATED,,PHASE1,2.0,ACTUAL,Eureka Therapeutics Inc.,,1.0,,Reallocation of resources to new HCC study.,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,INDUSTRY,,,,,,,2020,0.0
NCT04083170,,2019-09-06,,2023-10-27,2024-06-03,2019-09-06,2019-09-10,ACTUAL,,,,,2023-11-22,ACTUAL,2024-06-03,2024-06-06,ACTUAL,2022-10-06,ACTUAL,2022-10-06,2024-05,2024-05-31,2022-11-30,ACTUAL,2022-11-30,2022-11-11,ACTUAL,2022-11-11,,INTERVENTIONAL,,,Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers,Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Progenitor Cells to Facilitate the Engraftment of a Single CCR5Δ32 Homozygous or Heterozygous Cord Blood Unit in Patients With HIV and Hematological Malignancies,TERMINATED,,PHASE2,1.0,ACTUAL,Fred Hutchinson Cancer Center,,2.0,,"The federal funding period ended. The study was originally intended to be multi-site but was only conducted at the lead site. Due to the rarity of the subject population \& smaller # of enrolling sites, we were not able to reach accrual goals.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,OTHER,,,,,,,2022,0.0
NCT02920710,,2016-09-29,,,2020-11-19,2016-09-29,2016-09-30,ESTIMATED,,,,,,,2020-11-19,2020-11-20,ACTUAL,2019-02-01,ACTUAL,2019-02-01,2020-11,2020-11-30,2020-11-02,ACTUAL,2020-11-02,2020-11-02,ACTUAL,2020-11-02,,INTERVENTIONAL,,,ACTHAR Therapy for Central Nervous System Sarcoidosis,ACTHAR Therapy for Central Nervous System Sarcoidosis,WITHDRAWN,,PHASE4,0.0,ACTUAL,The Cleveland Clinic,,1.0,,Difficulty with recruitment,,,,,f,t,f,,,f,,,,,,UNDECIDED,,2024-10-15 18:51:04.168811,2024-10-15 18:51:04.168811,OTHER,,,,,,,2020,0.0
NCT04492618,,2020-07-27,2023-01-12,,2023-01-12,2020-07-27,2020-07-30,ACTUAL,2023-01-12,2023-02-08,ACTUAL,,,,2023-01-12,2023-02-08,ACTUAL,2020-09-29,ACTUAL,2020-09-29,2023-01,2023-01-31,2022-03-16,ACTUAL,2022-03-16,2022-03-16,ACTUAL,2022-03-16,,INTERVENTIONAL,,,Ruxolitinib Cream in the Treatment of Cutaneous Necrobiosis Lipoidica,Ruxolitinib Cream in the Treatment of Cutaneous Necrobiosis Lipoidica,COMPLETED,,PHASE2,12.0,ACTUAL,Mayo Clinic,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,OTHER,,,,,,,2022,1.0
NCT05048940,,2021-09-08,,,2023-02-28,2021-09-16,2021-09-17,ACTUAL,,,,,,,2023-02-28,2023-03-02,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2023-02,2023-02-28,2021-09-01,ESTIMATED,2021-09-01,2021-09-01,ESTIMATED,2021-09-01,,INTERVENTIONAL,REIN-TX,,"Efficacy, Safety, and Immunogenicity of Vaccine Reimmunization With a Third Homologous Versus Heterologous Dose Against COVID-19 in Patients Undergoing Solid Organ Transplantation.","Randomized, Open-label, Adaptive, Controlled, Phase III Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of Reimmunization With Third Dose of Homologous vs. Heterologous Vaccine Against COVID-19 in Patients Undergoing Solid Organ Transplantation: Liver, Heart, Kidney and Lung.",WITHDRAWN,,PHASE3,0.0,ACTUAL,Instituto de Investigación Marqués de Valdecilla,,2.0,,The health authority indicates that the official vaccination schedule differs from that described in the protocol.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,OTHER,,,,,,,2021,0.0
NCT05663086,,2022-12-22,,,2023-09-24,2022-12-22,2022-12-23,ACTUAL,,,,,,,2023-09-24,2023-09-26,ACTUAL,2023-01-07,ACTUAL,2023-01-07,2022-12,2022-12-31,2023-06-27,ACTUAL,2023-06-27,2023-06-27,ACTUAL,2023-06-27,,INTERVENTIONAL,,,Immunogenicity and Safety of COVID-19 Vaccine in Population Aged 18 Years and Above,"A Randomized, Blinded, Positive-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in Population Aged 18 Years and Above（Negative for Antibody Against COVID-19）",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Guangzhou Patronus Biotech Co., Ltd.",,3.0,,According to the development of the novel coronavirus epidemic situation and the company's R\&D decision,f,,,,t,f,f,,,,,,,,,,,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,INDUSTRY,,,,,,,2023,0.0
NCT03051035,,2017-01-30,,,2021-09-16,2017-02-08,2017-02-13,ACTUAL,,,,,,,2021-09-16,2021-09-20,ACTUAL,2017-04-06,ACTUAL,2017-04-06,2021-09,2021-09-30,2020-06-02,ACTUAL,2020-06-02,2020-06-02,ACTUAL,2020-06-02,,INTERVENTIONAL,,,First-in-Human Study of KO-947 in Non-Hematological Malignancies,"A Phase 1 First-in-Human Study of KO-947 in Locally Advanced Unresectable or Metastatic, Relapsed and/or Refractory Non-Hematological Malignancies",TERMINATED,,PHASE1,61.0,ACTUAL,"Kura Oncology, Inc.",,1.0,,Due to a strategic business decision Kura has stopped development of KO-947. Neither safety nor efficacy reasons were the cause of study termination.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,INDUSTRY,,,,,,,2020,0.0
NCT04194034,,2019-12-08,,,2023-06-21,2019-12-10,2019-12-11,ACTUAL,,,,,,,2023-06-21,2023-06-23,ACTUAL,2020-01-17,ACTUAL,2020-01-17,2023-06,2023-06-30,2023-02-23,ACTUAL,2023-02-23,2023-02-23,ACTUAL,2023-02-23,,INTERVENTIONAL,,,Study of Intrahepatic Arterial Infusion of TG6002 in Combination With 5-FC in Patients With Metastatic Colorectal Cancer,A Dose-escalation and Phase IIa Study of TG6002 Plus Flucytosine in Patients With Unresectable Colorectal Cancer With Liver Metastases,TERMINATED,,PHASE1/PHASE2,15.0,ACTUAL,Transgene,,1.0,,Study has been terminated after Phase I part on 23 February 2023,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,INDUSTRY,,,,,,,2023,0.0
NCT04748783,,2021-02-09,2022-02-10,,2022-02-10,2021-02-09,2021-02-10,ACTUAL,2022-02-10,2022-02-16,ACTUAL,,,,2022-02-10,2022-02-16,ACTUAL,2021-03-26,ACTUAL,2021-03-26,2021-04,2021-04-30,2021-04-07,ACTUAL,2021-04-07,2021-04-07,ACTUAL,2021-04-07,,INTERVENTIONAL,COL,Study terminated after enrollment of only 2 participants.,Antiviral Efficacy and Acceptability of Mouth Rinses for Inactivation of COVID-19,Antiviral Efficacy and Acceptability of Therapeutic Antiseptic Mouth Rinses for Inactivation of COVID SARS-2 Virus,TERMINATED,,PHASE2,2.0,ACTUAL,"University of North Carolina, Chapel Hill",,5.0,,Funding withdrawn,f,,,,f,t,f,,,f,,,Following publication up to 1 year,"Investigator who proposes to use the data has approval from an IRB, IEC, or REB as applicable, and an executed data use/sharing agreement with UNC.",,YES,"Deidentified individual data that supports the results will be shared beginning following publication up to 1 year provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.",2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,OTHER,,,,,,,2021,0.0
NCT05379322,,2022-05-12,,,2023-03-13,2022-05-17,2022-05-18,ACTUAL,,,,,,,2023-03-13,2023-03-15,ACTUAL,2022-07,ESTIMATED,2022-07-31,2023-03,2023-03-31,2024-04,ESTIMATED,2024-04-30,2023-10,ESTIMATED,2023-10-31,,INTERVENTIONAL,SYBRA,,The Use of Synovial Biopsies in Predicting Response to Biologic Therapy in Rheumatoid Arthritis Patients,The Use of Synovial Biopsies in Predicting Response to Biologic Therapy in Rheumatoid Arthritis Patients,WITHDRAWN,,PHASE3,0.0,ACTUAL,Abu Dhabi Stem Cells Center,,3.0,,Decision of the local healthcare authority,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,OTHER_GOV,,,,,,,2024,0.0
NCT04523792,,2020-08-19,,,2021-02-09,2020-08-21,2020-08-24,ACTUAL,,,,,,,2021-02-09,2021-02-12,ACTUAL,2021-01-01,ESTIMATED,2021-01-01,2021-02,2021-02-28,2021-12-31,ESTIMATED,2021-12-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,VOT-ED,,Virginia Opioid Treatment-Emergency Department,Virginia Opioid Treatment-Emergency Department,WITHDRAWN,,PHASE3,0.0,ACTUAL,Virginia Commonwealth University,,1.0,,Funder has not approved protocol,,,,,,t,f,,,,,,,,,,,2024-10-16 07:00:13.345362,2024-10-16 07:00:13.345362,OTHER,,,,,,,2021,0.0
NCT04329923,,2020-03-30,2020-11-13,,2020-12-08,2020-03-30,2020-04-01,ACTUAL,2020-12-08,2020-12-10,ACTUAL,,,,2020-12-08,2020-12-10,ACTUAL,2020-04-09,ACTUAL,2020-04-09,2020-12,2020-12-31,2020-11-13,ACTUAL,2020-11-13,2020-11-11,ACTUAL,2020-11-11,,INTERVENTIONAL,PATCH,All randomized patients,The PATCH Trial (Prevention And Treatment of COVID-19 With Hydroxychloroquine),The PATCH Trial (Prevention And Treatment of COVID-19 With Hydroxychloroquine),TERMINATED,,PHASE2,173.0,ACTUAL,University of Pennsylvania,Sub-study 1 was terminated early after the first interim analysis due to slow accrual Sub-study 2 was terminated early after the first 7 patients based on the recommendation of UPenn research oversight committees Sub-study 3 was terminated early due to meeting futility criteria on a pre-specified second interim analysis,6.0,,Cohort 1: slow accrual Cohort 2: Other studies showed no benefit Cohort 3: Study met pre-specificied futility analysis at planned second interim analysis,f,,,,f,t,f,,,f,,,One year after study completion,Open access,,YES,We will publish our results in a peer-reviewed journal and make available de-identified data for additional analysis,2024-10-16 07:05:33.558621,2024-10-16 07:05:33.558621,OTHER,,,,,,,2020,0.0
NCT06000514,,2023-07-19,,,2023-08-17,2023-08-17,2023-08-21,ACTUAL,,,,,,,2023-08-17,2023-08-21,ACTUAL,2019-01-17,ACTUAL,2019-01-17,2023-08,2023-08-31,2022-07-07,ACTUAL,2022-07-07,2022-04-06,ACTUAL,2022-04-06,,INTERVENTIONAL,,,Topical Sm29 in Combination With Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis.,Association of Topical Sm29 in Gold Nanoparticles With Intravenous Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania Braziliensis: A Randomized Controlled Trial.,COMPLETED,,PHASE1/PHASE2,20.0,ACTUAL,Hospital Universitário Professor Edgard Santos,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,Not to be shared.,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,OTHER,,,,,,,2022,1.0
NCT02674529,,2016-01-22,2022-06-23,2022-04-29,2022-10-11,2016-02-01,2016-02-04,ESTIMATED,2022-10-11,2022-11-03,ACTUAL,2022-04-29,2022-05-09,ACTUAL,2022-10-11,2022-11-03,ACTUAL,2016-09,ACTUAL,2016-09-30,2022-10,2022-10-31,2021-05,ACTUAL,2021-05-31,2021-05,ACTUAL,2021-05-31,,INTERVENTIONAL,SONRISA,,Study of Neural Responses Induced by Antidepressant Effects,Study of Neural Responses Induced by Simulated Antidepressants,COMPLETED,,PHASE2/PHASE3,60.0,ACTUAL,University of Pittsburgh,,2.0,,,f,,,,t,,,,,,,,,,,YES,"The study will follow NIMH schedule for data sharing for clinical trials. The schedule allows for descriptive data to be submitted - but not shared - ongoing and results associated with a finding - both positive and negative - to be submitted prior to the communication of a result. Once a result is communicated, either through publication and/or on the NDCT website the data specifically defined to the clinical trial will then be shared.",2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,OTHER,,,,,,,2021,1.0
NCT04354389,,2020-04-15,,,2020-08-07,2020-04-16,2020-04-21,ACTUAL,,,,,,,2020-08-07,2020-08-11,ACTUAL,2020-07-25,ESTIMATED,2020-07-25,2020-08,2020-08-31,2020-11-30,ESTIMATED,2020-11-30,2020-09-30,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,DAS181 for STOP COVID-19,"DAS181 for COVID-19: A Phase II Multicenter, Randomized, Placebo-Controlled, Double-Blind Study",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,"Ansun Biopharma, Inc.",,3.0,,No COVID-19 in EU countries - Sponsor withdraw in regulatory stage,f,,,,,t,f,,,t,,,,,,NO,,2024-10-15 18:51:04.168811,2024-10-15 18:51:04.168811,INDUSTRY,,,,,,,2020,0.0
NCT03354611,,2017-11-21,,,2023-03-14,2017-11-25,2017-11-28,ACTUAL,,,,,,,2023-03-14,2023-03-16,ACTUAL,2018-09-10,ACTUAL,2018-09-10,2021-02,2021-02-28,2021-09-01,ACTUAL,2021-09-01,2021-09-01,ACTUAL,2021-09-01,,INTERVENTIONAL,,,Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging,Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging,TERMINATED,,PHASE2/PHASE3,21.0,ACTUAL,Koning Corporation,,1.0,,The study progress doesn't meet the sponsor's requirement,f,,,,f,f,t,,,f,,,,,,NO,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,INDUSTRY,,,,,,,2021,0.0
NCT04334629,,2020-04-02,,,2023-07-24,2020-04-02,2020-04-06,ACTUAL,,,,,,,2023-07-24,2023-07-25,ACTUAL,2020-05-26,ACTUAL,2020-05-26,2020-05,2020-05-31,2021-09-25,ACTUAL,2021-09-25,2021-05-25,ACTUAL,2021-05-25,,INTERVENTIONAL,LIBERATE,,LIBERATE Trial in COVID-19,"Lipid Ibuprofen Versus Standard of Care for Acute Hypoxemic Respiratory Failure Due to COVID-19: a Multicentre, Randomised, Controlled Trial",WITHDRAWN,,PHASE4,0.0,ACTUAL,King's College London,,2.0,,Study withdrawn.,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,OTHER,,,,,,,2021,0.0
NCT03310593,,2017-06-15,,,2021-06-30,2017-10-13,2017-10-16,ACTUAL,,,,,,,2021-06-30,2021-07-02,ACTUAL,2017-11-01,ACTUAL,2017-11-01,2021-06,2021-06-30,2020-03-24,ACTUAL,2020-03-24,2020-02-24,ACTUAL,2020-02-24,,INTERVENTIONAL,CBDBD,,Cannabidiol as an Adjunctive Treatment for Bipolar Depression,"A Double-blind, Randomized, Placebo-controlled Clinical Trial of Adjunctive Cannabidiol for Bipolar Depression",TERMINATED,,PHASE2/PHASE3,36.0,ACTUAL,Hospital de Clinicas de Porto Alegre,,2.0,,It was interrupted due to the coronavirus pandemic outbreak.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,OTHER,,,,,,,2020,0.0
NCT04425733,,2020-06-08,,,2020-08-12,2020-06-08,2020-06-11,ACTUAL,,,,,,,2020-08-12,2020-08-14,ACTUAL,2020-07-07,ESTIMATED,2020-07-07,2020-08,2020-08-31,2020-11-10,ESTIMATED,2020-11-10,2020-11-10,ESTIMATED,2020-11-10,,INTERVENTIONAL,,,MK-5475 in Participants With Hypoxemia Due to COVID-19 Pneumonia (MK-5475-009),"A Study to Assess the Safety, Tolerability, and Pharmacodynamics of Multiple Dose MK-5475 in Participants With Hypoxemia Due to COVID-19 Pneumonia",WITHDRAWN,,PHASE1,0.0,ACTUAL,Merck Sharp & Dohme LLC,,6.0,,Business reasons,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,INDUSTRY,,,,,,,2020,0.0
NCT02644525,,2015-12-31,2022-01-03,,2022-05-13,2015-12-31,2016-01-01,ESTIMATED,2022-05-13,2022-06-07,ACTUAL,,,,2022-05-13,2022-06-07,ACTUAL,2019-09-16,ACTUAL,2019-09-16,2021-03,2021-03-31,2021-03-19,ACTUAL,2021-03-19,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Efficacy and Microfilaricidal Kinetics of Imatinib for the Treatment of Loa Loa,"A Double-blinded, Randomized, Placebo-Controlled Dose Escalation Study to Examine the Efficacy and Microfilaricidal Kinetics and Safety of Imatinib for the Treatment of Loa Loa (A Pilot Study)",TERMINATED,,PHASE2,20.0,ACTUAL,National Institutes of Health Clinical Center (CC),,4.0,,Planned interim analysis demonstrated futility of intervention,f,,,,,f,f,,,,,,,,,,,2024-10-16 07:05:33.558621,2024-10-16 07:05:33.558621,NIH,,,,,,,2021,0.0
NCT03274440,,2017-09-05,2020-05-15,,2020-10-29,2017-09-05,2017-09-07,ACTUAL,2020-06-19,2020-06-23,ACTUAL,,,,2020-10-29,2020-11-18,ACTUAL,2017-10-01,ACTUAL,2017-10-01,2020-10,2020-10-31,2020-10-29,ACTUAL,2020-10-29,2019-03-01,ACTUAL,2019-03-01,,INTERVENTIONAL,ECOS,Baseline characteristics for all study completers,Effects of Marijuana on Symptoms of OCD,Effects of Marijuana on Symptoms of Obsessive-Compulsive Disorder,COMPLETED,,PHASE1/PHASE2,14.0,ACTUAL,New York State Psychiatric Institute,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,OTHER,,,,,,,2020,1.0
NCT05109650,,2021-10-27,,,2023-04-27,2021-10-27,2021-11-05,ACTUAL,,,,,,,2023-04-27,2023-05-01,ACTUAL,2021-11-15,ACTUAL,2021-11-15,2023-04,2023-04-30,2023-03-23,ACTUAL,2023-03-23,2023-03-23,ACTUAL,2023-03-23,,INTERVENTIONAL,,,Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumour Patients,"A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6026 as Monotherapy and in Combination With BAT1308 in Patients With Advanced Solid Tumours",TERMINATED,,PHASE1,13.0,ACTUAL,Bio-Thera Solutions,,6.0,,"Considering that the high budget will affect the subsequent development, it is decided to terminate the test voluntarily",f,,,,f,f,f,,,,,,,,,NO,no plan to share IPD,2024-10-15 09:55:41.999696,2024-10-15 09:55:41.999696,INDUSTRY,,,,,,,2023,0.0
NCT05651711,,2022-12-07,,,2024-10-11,2022-12-07,2022-12-15,ACTUAL,,,,,,,2024-10-11,2024-10-15,ACTUAL,2022-12-14,ACTUAL,2022-12-14,2024-10,2024-10-31,2024-08-23,ACTUAL,2024-08-23,2024-06-05,ACTUAL,2024-06-05,,INTERVENTIONAL,ROCKET-Horizon,,A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon),"A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)",COMPLETED,,PHASE3,726.0,ACTUAL,Amgen,,2.0,,,f,,,,t,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-17 04:29:36.018885,2024-10-17 04:29:36.018885,INDUSTRY,,,,,,,2024,1.0
NCT05434091,,2022-06-22,,,2022-09-02,2022-06-22,2022-06-27,ACTUAL,,,,,,,2022-09-02,2022-09-07,ACTUAL,2022-08-15,ESTIMATED,2022-08-15,2022-09,2022-09-30,2023-03-29,ESTIMATED,2023-03-29,2023-03-29,ESTIMATED,2023-03-29,,INTERVENTIONAL,,,"A First-In-Human Study of the Study Medicine, Called PF-07291177, in Healthy Adult Participants","A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, 4-PERIOD, CROSSOVER, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ASCENDING ORAL DOSES OF PF 07291177 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS",WITHDRAWN,,PHASE1,0.0,ACTUAL,Pfizer,,3.0,,Study stopped due to change in strategy.,f,,,,f,t,f,,,t,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2023,0.0
NCT05070754,,2021-09-27,2023-12-01,,2024-03-30,2021-09-27,2021-10-07,ACTUAL,2024-03-30,2024-04-05,ACTUAL,,,,2024-03-30,2024-04-05,ACTUAL,2021-12-02,ACTUAL,2021-12-02,2024-03,2024-03-31,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca,Using a Cold Atmospheric Plasma Device to Treat Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients,COMPLETED,,PHASE4,17.0,ACTUAL,Medical University of South Carolina,"Limitations:~* Study was adequately powered with the number of lesions, but a small number of patients enrolled~* Low enrollment of patients with skin of color~* Patients limited to only three treatments with the NTAP device~* Assessment of sustained treatment response was limited to 4 weeks after treatment \& may not represent long-term response~* Post-treatment sequelae were measured at the end of the study period. We are unable to determine whether they persisted or self-resolved.",3.0,,,f,,,,f,t,t,,,f,,,,,,NO,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,OTHER,,,,,Lesions,,2022,1.0
NCT05127473,,2021-11-09,,,2023-10-31,2021-11-09,2021-11-19,ACTUAL,,,,,,,2023-10-31,2023-11-01,ACTUAL,2021-07-14,ACTUAL,2021-07-14,2023-10,2023-10-31,2022-05-14,ACTUAL,2022-05-14,2022-05-14,ACTUAL,2022-05-14,,INTERVENTIONAL,,,A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People,"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of Reformulated NNC0365-3769 (Mim8) in Healthy Male Participants",COMPLETED,,PHASE1,66.0,ACTUAL,Novo Nordisk A/S,,12.0,,,f,,,,f,f,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 10:01:13.767331,2024-10-15 10:01:13.767331,INDUSTRY,,,,,,,2022,1.0
NCT03937791,,2019-05-03,2021-02-24,,2021-03-18,2019-05-03,2019-05-06,ACTUAL,2021-02-24,2021-03-18,ACTUAL,,,,2021-03-18,2021-04-13,ACTUAL,2019-10-09,ACTUAL,2019-10-09,2021-03,2021-03-31,2020-06-22,ACTUAL,2020-06-22,2020-06-22,ACTUAL,2020-06-22,,INTERVENTIONAL,,,Immunotherapy With E7 T Cell Receptor T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions,A Phase II Study of Immunotherapy With E7 T Cell Receptor T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions,TERMINATED,,PHASE2,1.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,All analysis with identifiable specimens/data is complete or site has no identifiers linked to the specimens/data. The one enrolled pt has been taken off study,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,NIH,,,,,,,2020,0.0
NCT04405908,,2020-05-25,,,2022-02-17,2020-05-25,2020-05-28,ACTUAL,,,,,,,2022-02-17,2022-02-18,ACTUAL,2020-06-19,ACTUAL,2020-06-19,2022-02,2022-02-28,2021-12-08,ACTUAL,2021-12-08,2021-10-20,ACTUAL,2021-10-20,,INTERVENTIONAL,,,SCB-2019 as COVID-19 Vaccine,"A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety and Immunogenicity of SCB 2019, a Recombinant SARS-CoV-2 Trimeric S Protein Subunit Vaccine for COVID-19 in Healthy Volunteers.",COMPLETED,,PHASE1,166.0,ACTUAL,Clover Biopharmaceuticals AUS Pty Ltd,,27.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2021,1.0
NCT04795466,,2021-03-10,,,2024-05-08,2021-03-10,2021-03-12,ACTUAL,,,,,,,2024-05-08,2024-05-10,ACTUAL,2021-10-28,ACTUAL,2021-10-28,2024-05,2024-05-31,2024-03-07,ACTUAL,2024-03-07,2024-03-07,ACTUAL,2024-03-07,,INTERVENTIONAL,,,Study of the Efficacy and Safety of Various Anti-inflammatory Agents in Participants With Mild Cognitive Impairment or Mild Alzheimer's Disease,"Exploratory PLatform Trial on Anti-Inflammatory Agents in Alzheimer's Disease (EXPLAIN-AD): A Randomized, Placebo-controlled, Multicenter Platform Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Various Anti-inflammatory Agents in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease",TERMINATED,,PHASE2,34.0,ACTUAL,Novartis,,2.0,,Terminated by Novartis for strategic reasons.. Decision was not safety related.,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/",2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2024,0.0
NCT04061798,,2019-08-18,,,2024-08-06,2019-08-18,2019-08-20,ACTUAL,,,,,,,2024-08-06,2024-08-09,ACTUAL,2020-03-02,ACTUAL,2020-03-02,2024-08,2024-08-31,2024-04-29,ACTUAL,2024-04-29,2024-04-13,ACTUAL,2024-04-13,,INTERVENTIONAL,ACTION-1,,ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair.,"ACTION-1: ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair, a Randomised Trial.",TERMINATED,,PHASE4,294.0,ACTUAL,Dijklander Ziekenhuis,,2.0,,Futility,f,,,,t,f,f,,,,,,"after data lock, 07-2024",contract with pre-defined criteria according to government regulation concerning science research,,YES,under pre-defined conditions and contract,2024-10-16 07:05:33.558621,2024-10-16 07:05:33.558621,OTHER,,,,,,,2024,0.0
NCT04075396,,2019-08-21,2023-12-19,2022-01-04,2024-02-02,2019-08-29,2019-08-30,ACTUAL,2024-02-02,2024-02-28,ACTUAL,,2024-02-28,ACTUAL,2024-02-02,2024-02-28,ACTUAL,2019-10-16,ACTUAL,2019-10-16,2024-01,2024-01-31,2022-11-14,ACTUAL,2022-11-14,2021-01-08,ACTUAL,2021-01-08,,INTERVENTIONAL,,The safety analysis population included all participants who received at least 1 dose of investigational product (IP).,A Study of Lazertinib in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC),"A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients With EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)",COMPLETED,,PHASE1/PHASE2,29.0,ACTUAL,"Janssen Research & Development, LLC","Study Parts A, B, and C were sponsored by Yuhan Corporation under protocol identifier (ID) YH25448-201 and Part D was sponsored by Janssen Research and Development, LLC under protocol ID 73841937NSC2001. Therefore, only Part D results are reported.",1.0,,,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 18:51:04.168811,2024-10-15 18:51:04.168811,INDUSTRY,,,,,,,2022,0.0
NCT03637868,,2018-08-06,,,2020-05-05,2018-08-16,2018-08-20,ACTUAL,,,,,,,2020-05-05,2020-05-06,ACTUAL,2019-02-26,ACTUAL,2019-02-26,2020-05,2020-05-31,2020-04-14,ACTUAL,2020-04-14,2020-04-14,ACTUAL,2020-04-14,,INTERVENTIONAL,ERIBRAIN,,Eribulin in Brain Metastases From HER2-negative Breast Cancer,A Phase II Study of Eribulin in Brain Metastases From HER2-negative Breast Cancer Pre-treated With Anthracyclines and Taxanes,WITHDRAWN,,PHASE2,0.0,ACTUAL,Institut Paoli-Calmettes,,1.0,,no enrollment,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 07:05:33.558621,2024-10-16 07:05:33.558621,OTHER,,,,,,,2020,0.0
NCT05191862,,2021-12-10,,,2023-04-12,2022-01-10,2022-01-14,ACTUAL,,,,,,,2023-04-12,2023-04-13,ACTUAL,2022-04-23,ACTUAL,2022-04-23,2023-04,2023-04-30,2022-05-07,ACTUAL,2022-05-07,2022-05-04,ACTUAL,2022-05-04,,INTERVENTIONAL,,,Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers,"An Open-Label, Randomized, Two-Treatment, Two-Sequence, Four-Period, Fully Replicated Crossover Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers",TERMINATED,,PHASE1,19.0,ACTUAL,"Genovate Biotechnology Co., Ltd.,",,2.0,,Randomization Error,f,,,,f,t,f,,,,,,,,,,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2022,0.0
NCT03807063,,2019-01-14,,,2020-08-12,2019-01-15,2019-01-16,ACTUAL,,,,,,,2020-08-12,2020-08-14,ACTUAL,2020-01-02,ACTUAL,2020-01-02,2020-08,2020-08-31,2021-12-31,ESTIMATED,2021-12-31,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Rivogenlecleucel Donor Lymphocyte Immunotherapy in Treating Patients With Recurrent Blood Cancers After Stem Cell Transplant,Phase I Trial With Off-The-Shelf Third-Party BPX-501 Donor Lymphocyte Immunotherapy to Treat Persistence or Relapse of Hematologic Malignancies After Allogeneic Stem Cell Transplantation,WITHDRAWN,,PHASE1,0.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,Insufficient funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:01:13.767331,2024-10-15 10:01:13.767331,OTHER,,,,,,,2021,0.0
NCT02697201,,2016-02-18,,,2021-07-23,2016-02-26,2016-03-03,ESTIMATED,,,,,,,2021-07-23,2021-07-27,ACTUAL,2016-07,,2016-07-31,2021-07,2021-07-31,2021-05,ACTUAL,2021-05-31,2021-05,ACTUAL,2021-05-31,,INTERVENTIONAL,DYNAMMO-T2D,,Dynamics of Muscle Mitochondria in Type 2 Diabetes (DYNAMMO T2D),Dynamics of Muscle Mitochondria in Type 2 Diabetes (DYNAMMO-T2D),COMPLETED,,EARLY_PHASE1,25.0,ACTUAL,Pennington Biomedical Research Center,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 18:51:04.168811,2024-10-15 18:51:04.168811,OTHER,,,,,,,2021,1.0
NCT01896531,,2013-07-08,2022-01-25,2016-07-15,2022-02-18,2013-07-08,2013-07-11,ESTIMATED,2022-01-25,2022-02-17,ACTUAL,2016-07-15,2016-07-19,ESTIMATED,2022-02-18,2022-03-02,ACTUAL,2013-08-14,ACTUAL,2013-08-14,2022-02,2022-02-28,2021-01-26,ACTUAL,2021-01-26,2015-06-03,ACTUAL,2015-06-03,,INTERVENTIONAL,,,A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer,"A Randomized, Phase II, Placebo-controlled Study of Ipatasertib (GDC-0068), an Inhibitor to Akt, in Combination With Fluoropyrimidine Plus Oxaliplatin in Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma",COMPLETED,,PHASE2,153.0,ACTUAL,"Genentech, Inc.",,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 10:01:13.767331,2024-10-15 10:01:13.767331,INDUSTRY,,,,,,,2021,1.0
NCT02999854,,2016-12-19,2022-03-29,,2022-04-28,2016-12-19,2016-12-21,ESTIMATED,2022-04-28,2022-05-24,ACTUAL,,,,2022-04-28,2022-05-24,ACTUAL,2017-11-29,ACTUAL,2017-11-29,2022-04,2022-04-30,2021-12-17,ACTUAL,2021-12-17,2021-11-09,ACTUAL,2021-11-09,,INTERVENTIONAL,HATCY,,Safety and Efficacy of ATIR101 as Adjunctive Treatment to Blood Stem Cell Transplantation From a Haploidentical Family Donor Compared to Post-transplant Cyclophosphamide in Patients With Blood Cancer,"A Phase III, Multicenter, Randomized Controlled Study to Compare Safety and Efficacy of a Haploidentical HSCT and Adjunctive Treatment With ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells, Versus a Haploidentical HSCT With Post-transplant Cyclophosphamide in Patients With a Hematologic Malignancy",TERMINATED,,PHASE3,63.0,ACTUAL,Kiadis Pharma,,2.0,,"Insufficient efficacy, terminated by Sponsor",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:01:13.767331,2024-10-15 10:01:13.767331,INDUSTRY,,,,,,,2021,0.0
NCT03254732,,2016-12-23,,,2022-04-20,2017-08-16,2017-08-18,ACTUAL,,,,,,,2022-04-20,2022-04-27,ACTUAL,2017-07-14,ACTUAL,2017-07-14,2020-03,2020-03-31,2020-02-25,ACTUAL,2020-02-25,2019-05-07,ACTUAL,2019-05-07,,INTERVENTIONAL,,,Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers,Phase 1B Study of ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers,TERMINATED,,PHASE1,33.0,ACTUAL,Polaris Group,,1.0,,Changing Corporate Priorities,f,,,,f,t,f,,,,,,,,,,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2020,0.0
NCT03724084,,2018-10-26,2023-12-01,,2024-05-16,2018-10-26,2018-10-30,ACTUAL,2024-05-16,2024-06-11,ACTUAL,,,,2024-05-16,2024-06-11,ACTUAL,2019-04-10,ACTUAL,2019-04-10,2024-05,2024-05-31,2022-11-14,ACTUAL,2022-11-14,2022-11-14,ACTUAL,2022-11-14,,INTERVENTIONAL,,,Pinometostat With Standard Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and MLL Gene Rearrangement,A Phase 1b/2 Study of Pinometostat in Combination With Standard Induction Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia With MLL Rearrangement,TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,National Cancer Institute (NCI),Study terminated early due to investigational product not being available,2.0,,Other - Study agent no longer available,f,,,,f,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page",2024-10-15 10:01:13.767331,2024-10-15 10:01:13.767331,NIH,,,,,,,2022,0.0
NCT03592264,,2018-05-21,,,2024-10-11,2018-07-09,2018-07-19,ACTUAL,,,,,,,2024-10-11,2024-10-15,ACTUAL,2018-07-02,ACTUAL,2018-07-02,2024-04,2024-04-30,2024-03-21,ACTUAL,2024-03-21,2024-02-13,ACTUAL,2024-02-13,,INTERVENTIONAL,,,A Phase I/II Study of OBI-3424 in Subjects with Advanced Solid Tumors,A Phase I/II Study of OBI-3424 in Subjects with Advanced Solid Tumors,TERMINATED,,PHASE1/PHASE2,68.0,ACTUAL,"OBI Pharma, Inc",,2.0,,Little evidence of clinical activity in tumor types enrolled,f,,,,f,t,f,,,f,,,,,,UNDECIDED,,2024-10-17 04:29:36.018885,2024-10-17 04:29:36.018885,INDUSTRY,,,,,,,2024,0.0
NCT03924154,,2019-04-05,,,2020-03-05,2019-04-22,2019-04-23,ACTUAL,,,,,,,2020-03-05,2020-03-09,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2019-08,2019-08-31,2020-02-24,ACTUAL,2020-02-24,2020-02-24,ACTUAL,2020-02-24,,INTERVENTIONAL,,,A Study of RVT-1201 in Patients With Pulmonary Arterial Hypertension (ELEVATE 1),"A Phase 2a, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of RVT-1201 in Patients With Pulmonary Arterial Hypertension",TERMINATED,,PHASE2,3.0,ACTUAL,Altavant Sciences GmbH,,2.0,,Inability to enroll,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2020,0.0
NCT02118584,,2014-04-16,,,2023-10-30,2014-04-16,2014-04-21,ESTIMATED,,,,,,,2023-10-30,2023-11-01,ACTUAL,2014-09-15,ACTUAL,2014-09-15,2023-10,2023-10-31,2023-10-05,ACTUAL,2023-10-05,2023-10-05,ACTUAL,2023-10-05,,INTERVENTIONAL,COTTONWOOD,,Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies,An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies,TERMINATED,,PHASE3,1822.0,ACTUAL,Hoffmann-La Roche,,2.0,,"The study was terminated due to program discontinuation, based on mixed efficacy results in the parent studies. There were no safety concerns.",f,,,,t,,,,,,,,,,,,,2024-10-15 10:01:13.767331,2024-10-15 10:01:13.767331,INDUSTRY,,,,,,,2023,0.0
NCT02807454,,2016-06-17,2023-01-03,,2023-02-16,2016-06-17,2016-06-21,ESTIMATED,2023-02-16,2023-02-21,ACTUAL,,,,2023-02-16,2023-02-21,ACTUAL,2016-07-07,ACTUAL,2016-07-07,2023-02,2023-02-28,2022-01-03,ACTUAL,2022-01-03,2022-01-03,ACTUAL,2022-01-03,,INTERVENTIONAL,FUSIONMM-003,,A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma,"A Phase 2, Multicenter, Open-label, Study to Determine the Safety and Efficacy for the Combination of Durvalumab (DURVA) and Daratumumab (DARA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)",TERMINATED,,PHASE2,37.0,ACTUAL,Celgene,This study stopped enrolling participants on 05-Sep-2017 and was terminated earlier than planned on 03-Jan-2022. This results disclosure report provides outputs from the Simon Stage 1: D2 and PD3 arms. Simon Stage 2: D2 did not enroll any participants.,2.0,,Health Authority request due to class effect,f,,,,f,,,,,,,,,,,,,2024-10-16 07:05:33.558621,2024-10-16 07:05:33.558621,INDUSTRY,,,,,,,2022,0.0
NCT04059094,,2019-08-15,2021-04-15,,2021-05-11,2019-08-15,2019-08-16,ACTUAL,2021-05-11,2021-06-04,ACTUAL,,,,2021-05-11,2021-06-04,ACTUAL,2019-09-16,ACTUAL,2019-09-16,2021-05,2021-05-31,2020-04-24,ACTUAL,2020-04-24,2020-04-16,ACTUAL,2020-04-16,,INTERVENTIONAL,,Treated set (TS): The TS included all patients who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.,A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1,"A Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Evaluate Efficacy and Safety of Twice Daily Inhaled Doses of BI 1265162 Delivered by Respimat® Inhaler as add-on Therapy to Standard of Care Over 4 Weeks in Patients With Cystic Fibrosis - BALANCE - CF™ 1",TERMINATED,,PHASE2,52.0,ACTUAL,Boehringer Ingelheim,This trial was prematurely discontinued with only adult patients being recruited.,5.0,,Not due to safety reasons,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://trials.boehringer-ingelheim.com,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.",2024-10-15 10:01:13.767331,2024-10-15 10:01:13.767331,INDUSTRY,,,,,,,2020,0.0
NCT03113409,,2017-04-10,2022-01-07,,2022-02-04,2017-04-10,2017-04-13,ACTUAL,2022-02-04,2022-03-02,ACTUAL,,,,2022-02-04,2022-03-02,ACTUAL,2017-06-01,ACTUAL,2017-06-01,2022-02,2022-02-28,2020-12-01,ACTUAL,2020-12-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,,,Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol,Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol,TERMINATED,,PHASE2/PHASE3,10.0,ACTUAL,New York State Psychiatric Institute,,3.0,,no funding available to continue,f,,,,t,t,f,,,,,,,,,,,2024-10-15 18:51:04.168811,2024-10-15 18:51:04.168811,OTHER,,,,,,,2020,0.0
NCT04243941,,2020-01-21,,,2024-03-19,2020-01-24,2020-01-28,ACTUAL,,,,,,,2024-03-19,2024-03-21,ACTUAL,2022-11-29,ACTUAL,2022-11-29,2024-03,2024-03-31,2024-02-07,ACTUAL,2024-02-07,2024-02-07,ACTUAL,2024-02-07,,INTERVENTIONAL,,,PSMA-PET/MRI Low- and Intermediate-Risk Prostate Cancer,LCCC 1917: Dose Escalation of Low and Intermediate Risk Localized Prostate Cancer Using 68Ga-HBED-CC PSMA-PET/MRI and Stereotactic Body Radiotherapy,WITHDRAWN,,PHASE2,0.0,ACTUAL,UNC Lineberger Comprehensive Cancer Center,,1.0,,Funding unavailable,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:51:04.168811,2024-10-15 18:51:04.168811,OTHER,,,,,,,2024,0.0
NCT04307693,,2020-03-10,,,2020-05-25,2020-03-12,2020-03-13,ACTUAL,,,,,,,2020-05-25,2020-05-27,ACTUAL,2020-03-11,ACTUAL,2020-03-11,2020-05,2020-05-31,2020-04-30,ACTUAL,2020-04-30,2020-04-30,ACTUAL,2020-04-30,,INTERVENTIONAL,,,Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19),Randomized Controlled Clinical Trials of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19),TERMINATED,,PHASE2,65.0,ACTUAL,Asan Medical Center,,3.0,,Terminated early because no patients were further enrolled since mid-Apr 2020.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 10:01:13.767331,2024-10-15 10:01:13.767331,OTHER,,,,,,,2020,0.0
NCT02993094,,2016-12-04,,,2020-11-26,2016-12-12,2016-12-15,ESTIMATED,,,,,,,2020-11-26,2020-11-30,ACTUAL,2016-11-21,ACTUAL,2016-11-21,2020-11,2020-11-30,2020-08-15,ACTUAL,2020-08-15,2020-08-15,ACTUAL,2020-08-15,,INTERVENTIONAL,,,Ixazomib (MLN9708) in Combination With Carboplatin in Pretreated Women With Advanced Triple Negative Breast Cancer,Ixazomib (MLN9708) in Combination With Carboplatin in Pretreated Women With Advanced Triple Negative Breast Cancer,TERMINATED,,PHASE1/PHASE2,31.0,ACTUAL,Arbeitsgemeinschaft medikamentoese Tumortherapie,,1.0,,"Due to slow recruitment, the study had to be terminated prematurely.",f,,,,f,,,,,,,,,,,NO,,2024-10-15 18:51:04.168811,2024-10-15 18:51:04.168811,OTHER,,,,,,,2020,0.0
NCT03757897,,2018-11-27,,,2022-05-24,2018-11-27,2018-11-29,ACTUAL,,,,,,,2022-05-24,2022-05-31,ACTUAL,2021-12,ESTIMATED,2021-12-31,2022-05,2022-05-31,2022-12,ESTIMATED,2022-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,"The Influence of Dexmedetomidine Hypnosis on Cerebrospinal Fluid (CSF) Volume, Brain Diffusion and 'Stiffness' Characteristics.","The Influence of Dexmedetomidine Hypnosis on Cerebrospinal Fluid (CSF) Volume, Brain Diffusion and 'Stiffness' Characteristics",WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Yale University,,1.0,,The investigators were unable to implement a MRI compatible EEG for use in human subjects (equipment and technical issues).,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 10:01:13.767331,2024-10-15 10:01:13.767331,OTHER,,,,,,,2022,0.0
NCT04235049,,2020-01-10,,,2021-04-30,2020-01-17,2020-01-21,ACTUAL,,,,,,,2021-04-30,2021-05-06,ACTUAL,2021-10-01,ESTIMATED,2021-10-01,2021-04,2021-04-30,2024-10-30,ESTIMATED,2024-10-30,2022-03-30,ESTIMATED,2022-03-30,,INTERVENTIONAL,ECLIPSE,,Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations (ECLIPSE),Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations,WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of Maryland, Baltimore",,4.0,,Department of Corrections unable to support study at this time and find agreement on publication issue.,f,,,,f,t,f,,,t,,,,,,,,2024-10-15 10:01:13.767331,2024-10-15 10:01:13.767331,OTHER,,,,,,,2024,0.0
NCT04797468,,2021-03-04,,,2023-01-13,2021-03-11,2021-03-15,ACTUAL,,,,,,,2023-01-13,2023-01-17,ACTUAL,2022-07-18,ACTUAL,2022-07-18,2023-01,2023-01-31,2023-01-13,ACTUAL,2023-01-13,2023-01-13,ACTUAL,2023-01-13,,INTERVENTIONAL,,,A Phase 1 Study of the CD73 Inhibitor(HLX23) Alone in Participants With Solid Tumor,"A Phase 1 Clinical Study to Investigate the Safety, Tolerability and to Determine the Maximum Tolerated Dose and Recommended Phase 2 Dose of HLX23 (CD73 Inhibitor) in Patients With Advanced or Metastatic Solid Tumors",WITHDRAWN,,PHASE1,0.0,ACTUAL,Shanghai Henlius Biotech,,1.0,,The Early Termination is the result of the sponsor's need to reevaluate the study design and to make needed vendor realignments.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 18:51:04.168811,2024-10-15 18:51:04.168811,INDUSTRY,,,,,,,2023,0.0
NCT05075304,,2021-08-22,,,2024-05-20,2021-10-08,2021-10-12,ACTUAL,,,,,,,2024-05-20,2024-05-21,ACTUAL,2020-02-21,ACTUAL,2020-02-21,2021-08,2021-08-31,2020-04-14,ACTUAL,2020-04-14,2020-04-14,ACTUAL,2020-04-14,,INTERVENTIONAL,,,"A Safety and Tolerability Study of BDB-001 in Mild, Moderate COVID-19 Patients","A Phase Ib, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BDB-001 Injection in Patients With Novel Coronavirus (2019-nCoV) Infection",TERMINATED,,PHASE1,18.0,ACTUAL,"Staidson (Beijing) Biopharmaceuticals Co., Ltd",,3.0,,"Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 10:01:13.767331,2024-10-15 10:01:13.767331,INDUSTRY,,,,,,,2020,0.0
NCT03724955,,2018-10-29,,,2019-04-16,2018-10-29,2018-10-30,ACTUAL,,,,,,,2019-04-16,2019-04-18,ACTUAL,2019-04,ESTIMATED,2019-04-30,2019-04,2019-04-30,2021-06,ESTIMATED,2021-06-30,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,Pilot E2 for Hypogonadal Women With CFBD,Pilot Study Evaluating the Effects of Estradiol for Hypogonadal Women With Cystic Fibrosis and Osteopenia,WITHDRAWN,,PHASE4,0.0,ACTUAL,Emory University,,2.0,,Issues with Recruitment.,f,,,,f,t,f,,,t,,,,,,,,2024-10-15 10:01:13.767331,2024-10-15 10:01:13.767331,OTHER,,,,,,,2021,0.0
NCT03408873,,2018-01-16,2021-09-15,,2022-01-26,2018-01-16,2018-01-24,ACTUAL,2022-01-26,2022-02-17,ACTUAL,,,,2022-01-26,2022-02-17,ACTUAL,2018-04-01,ACTUAL,2018-04-01,2022-01,2022-01-31,2020-05-06,ACTUAL,2020-05-06,2020-05-06,ACTUAL,2020-05-06,,INTERVENTIONAL,,,CAE Plus LAI in Individuals With Bipolar Disorder at Risk for Treatment Non-adherence (BD-CAEL),Enhancing Adherence and Outcomes in Bipolar Disorder With Abilify Maintena + a Targeted Behavioral Approach to Promote Sustained Adherence and Behavioral Change,COMPLETED,,PHASE4,30.0,ACTUAL,University Hospitals Cleveland Medical Center,"This study had a number of limitations including small sample, non-controlled design, and single-site setting. An additional limitation is that adherence was based upon self-report, which has potential to under-count missed medication. The improvement in adherence behaviors immediately after screen (and before CAE was administered) may possibly reflect a Hawthorne effect which could have obscured improvement in CAE-related change.",1.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 07:05:33.558621,2024-10-16 07:05:33.558621,OTHER,,,,,,,2020,1.0
NCT04278755,,2020-02-18,2022-06-20,,2022-07-21,2020-02-18,2020-02-20,ACTUAL,2022-07-21,2022-07-26,ACTUAL,,,,2022-07-21,2022-07-26,ACTUAL,2020-09-24,ACTUAL,2020-09-24,2022-06,2022-06-30,2022-05-17,ACTUAL,2022-05-17,2022-05-17,ACTUAL,2022-05-17,,INTERVENTIONAL,,,Binge Eating & Birth Control,A Mechanistic Examination of Continuous Cycle Oral Contractive Administration in Binge Eating,TERMINATED,,PHASE2,8.0,ACTUAL,"University of North Carolina, Chapel Hill",The study was terminated early due to the inability to recruit eligible participants therefore only a very small number of participants have available data.,1.0,,Halted prematurely due to COVID-19-related enrollment challenges.,f,,,,f,t,f,,,f,,,Deidentified individual data that supports the results will be shared beginning 18 to 24 months following publication upon reasonable request.,"Approval from an IRB, IEC, or REB, as applicable and execution of a data use/sharing agreement with UNC.",,YES,"Deidentified individual data that supports the results will be shared beginning 18 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina (UNC).",2024-10-15 18:51:04.168811,2024-10-15 18:51:04.168811,OTHER,,,,,,,2022,0.0
NCT05088421,,2021-09-09,,,2023-07-05,2021-10-08,2021-10-21,ACTUAL,,,,,,,2023-07-05,2023-07-06,ACTUAL,2021-11-05,ACTUAL,2021-11-05,2023-07,2023-07-31,2023-05-28,ACTUAL,2023-05-28,2022-12-29,ACTUAL,2022-12-29,,INTERVENTIONAL,,,A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of BWC0977 in Healthy Volunteers,"A Randomized, Double-blind, Placebo-controlled, Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of BWC0977 in Healthy Adult Volunteers",COMPLETED,,PHASE1,44.0,ACTUAL,Bugworks Research Inc.,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 18:51:04.168811,2024-10-15 18:51:04.168811,INDUSTRY,,,,,,,2023,1.0
NCT03480022,,2018-03-13,2021-04-14,,2021-06-03,2018-03-20,2018-03-27,ACTUAL,2021-06-03,2021-06-07,ACTUAL,,,,2021-06-03,2021-06-07,ACTUAL,2018-09-26,ACTUAL,2018-09-26,2021-06,2021-06-30,2021-05-19,ACTUAL,2021-05-19,2021-02-22,ACTUAL,2021-02-22,,INTERVENTIONAL,SAXAPCOS,,"Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS","A Randomized Placebo-controlled Double Blind Trial of Liraglutide 3 mg [Saxenda] on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With Polycystic Ovary Syndrome (PCOS)",COMPLETED,,PHASE3,88.0,ACTUAL,Woman's,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,OTHER,,,,,,,2021,1.0
NCT02435433,,2015-05-01,2019-04-08,,2022-12-22,2015-05-01,2015-05-06,ESTIMATED,2019-04-25,2019-05-17,ACTUAL,,,,2022-12-22,2023-01-20,ACTUAL,2015-07-20,ACTUAL,2015-07-20,2022-12-01,2022-12-01,2021-11-19,ACTUAL,2021-11-19,2018-03-15,ACTUAL,2018-03-15,,INTERVENTIONAL,REACH-2,All participants who received at least one dose of study drug.,A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein,"Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ramucirumab and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (AFP) Following First-Line Therapy With Sorafenib",COMPLETED,,PHASE3,399.0,ACTUAL,Eli Lilly and Company,,5.0,,,f,,,,t,,,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://www.clinicalstudydatarequest.com/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2021,1.0
NCT05788991,,2023-03-15,2024-06-20,,2024-10-11,2023-03-28,2023-03-29,ACTUAL,2024-10-11,2024-10-16,ESTIMATED,,,,2024-10-11,2024-10-16,ESTIMATED,2021-07-26,ACTUAL,2021-07-26,2024-06,2024-06-30,2022-08-25,ACTUAL,2022-08-25,2022-08-25,ACTUAL,2022-08-25,,INTERVENTIONAL,,"Randomized= 151 patients but 4 did not receive study medication because of consent withdrawal (1 for dequalinium chloride, 3 for metronidazole) Received intervention= 147 (72 dequalinium chloride, 75 metronidazole) but 4 were missing the primary outcome assessment (3 for dequalinium chloride and 1 for metronidazole) Patients with data for primary endpoint analysis= 147 (69 dequalinium chloride, 74 metronidazole)",Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis,Comparative Study of the Efficacy and Safety of Vaginally Applied Dequalinium Chloride (10 mg) and Orally Applied Metronidazole (2 x 500 mg) in the Treatment of Bacterial Vaginosis,TERMINATED,,PHASE4,151.0,ACTUAL,Medinova AG,,2.0,,Slow recruitment,f,,,,f,f,f,,,,,,,,,,,2024-10-17 04:29:36.018885,2024-10-17 04:29:36.018885,INDUSTRY,,,,,,,2022,0.0
NCT05061992,,2021-09-20,2023-10-18,,2023-11-17,2021-09-20,2021-09-30,ACTUAL,2023-11-17,2023-11-21,ACTUAL,,,,2023-11-17,2023-11-21,ACTUAL,2021-11-10,ACTUAL,2021-11-10,2023-11,2023-11-30,2022-11-01,ACTUAL,2022-11-01,2022-11-01,ACTUAL,2022-11-01,,INTERVENTIONAL,,,A Trial to Improve Quality of Life in People With Cirrhosis,A Trial to Improve Quality of Life in People With Cirrhosis - the Michigan Kristalose Trial,COMPLETED,,PHASE2/PHASE3,56.0,ACTUAL,University of Michigan,,2.0,,,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,OTHER,,,,,,,2022,1.0
NCT05270863,,2022-02-25,2024-05-23,,2024-10-01,2022-02-25,2022-03-08,ACTUAL,2024-08-29,2024-09-05,ACTUAL,,,,2024-10-01,2024-10-15,ACTUAL,2022-03-30,ACTUAL,2022-03-30,2024-10,2024-10-31,2023-04-10,ACTUAL,2023-04-10,2023-03-17,ACTUAL,2023-03-17,,INTERVENTIONAL,,,Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia,"Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia",COMPLETED,,PHASE3,182.0,ACTUAL,Visus Therapeutics,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 04:29:36.018885,2024-10-17 04:29:36.018885,OTHER,,,,,,,2023,1.0
NCT02513667,,2015-07-30,2021-10-26,,2023-01-31,2015-07-30,2015-07-31,ESTIMATED,2021-12-16,2021-12-17,ACTUAL,,,,2023-01-31,2023-02-03,ACTUAL,2015-11,ACTUAL,2015-11-30,2023-01,2023-01-31,2021-05-29,ACTUAL,2021-05-29,2020-05-29,ACTUAL,2020-05-29,,INTERVENTIONAL,,1 patient withdrew consent before thier first scan.,Ceritinib in Combination With Stereotactic Ablative Radiation Metastatic Lung Adenocarcinoma,Phase II Trial of Ceritinib in Combination With Stereotactic Ablative Radiation in ALK-rearranged Metastatic Lung Adenocarcinoma,TERMINATED,,PHASE2,14.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,The study was terminated after UTSW was informed by Novartis that further support for the study would not be provided,f,,,,t,,,,,,,,,,,,,2024-10-15 18:51:04.168811,2024-10-15 18:51:04.168811,OTHER,,,,,,,2021,0.0
NCT03425799,,2018-01-23,2020-08-13,,2021-05-27,2018-02-01,2018-02-08,ACTUAL,2021-05-27,2021-06-21,ACTUAL,,,,2021-05-27,2021-06-21,ACTUAL,2018-10-17,ACTUAL,2018-10-17,2020-09,2020-09-30,2020-01-21,ACTUAL,2020-01-21,2019-10-23,ACTUAL,2019-10-23,,INTERVENTIONAL,,Not Available. Study Terminated and data were not collected.,Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery,Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery,TERMINATED,,PHASE3,5.0,ACTUAL,"Exela Pharma Sciences, LLC.",,2.0,,Low recruitment rate,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 07:05:33.558621,2024-10-16 07:05:33.558621,INDUSTRY,,,,,,,2020,0.0
NCT05366751,,2022-05-04,,,2024-10-10,2022-05-04,2022-05-09,ACTUAL,,,,,,,2024-10-10,2024-10-15,ACTUAL,2022-06-13,ACTUAL,2022-06-13,2024-10,2024-10-31,2024-09-10,ACTUAL,2024-09-10,2024-09-10,ACTUAL,2024-09-10,,INTERVENTIONAL,,,A Study to Evaluate the Long-term Safety and Tolerability of SAGE-324 in Participants With Essential Tremor,An Open-label Study of the Long-term Safety and Tolerability of SAGE-324 in Participants With Essential Tremor,TERMINATED,,PHASE2/PHASE3,97.0,ACTUAL,Sage Therapeutics,,1.0,,Internal company decision,f,,,,f,t,f,,,,,,,,,NO,Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.,2024-10-17 04:29:36.018885,2024-10-17 04:29:36.018885,INDUSTRY,,,,,,,2024,0.0
NCT04732468,,2021-01-27,2024-04-02,,2024-10-10,2021-01-28,2021-02-01,ACTUAL,2024-10-10,2024-10-15,ACTUAL,,,,2024-10-10,2024-10-15,ACTUAL,2021-02-24,ACTUAL,2021-02-24,2024-09,2024-09-30,2023-01-09,ACTUAL,2023-01-09,2022-07-11,ACTUAL,2022-07-11,,INTERVENTIONAL,,,COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA,"Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of Subcutaneously and Orally Administered Prophylactic Vaccination With 2nd Generation (E1/E2B/E3-Deleted) Adenoviral COVID-19 in Normal Healthy Volunteers",TERMINATED,,PHASE1,28.0,ACTUAL,"ImmunityBio, Inc.",The study was terminated early due to low enrollment.,4.0,,The study was terminated early due to low enrollment.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 04:29:36.018885,2024-10-17 04:29:36.018885,INDUSTRY,,,,,,,2023,0.0
NCT03234309,,2017-07-26,,,2021-11-03,2017-07-26,2017-07-31,ACTUAL,,,,,,,2021-11-03,2021-11-10,ACTUAL,2017-10-20,ACTUAL,2017-10-20,2021-11,2021-11-30,2021-08-30,ACTUAL,2021-08-30,2021-08-30,ACTUAL,2021-08-30,,INTERVENTIONAL,,,Ferumoxytol in Magnetic Resonance Imaging of Pediatric Patients With Brain Tumors,High Resolution Steady State Blood Volume Maps in Pediatric Brain Tumors Using MRI,WITHDRAWN,,PHASE2,0.0,ACTUAL,OHSU Knight Cancer Institute,,1.0,,No enrollments,f,,,,t,t,f,,,,,,,,,,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,OTHER,,,,,,,2021,0.0
NCT03802396,,2019-01-10,2024-06-28,2023-10-02,2024-10-03,2019-01-10,2019-01-14,ACTUAL,2024-08-09,2024-09-04,ACTUAL,,2024-09-04,ACTUAL,2024-10-03,2024-10-16,ESTIMATED,2018-07-15,ACTUAL,2018-07-15,2024-10,2024-10-31,2022-12-28,ACTUAL,2022-12-28,2022-12-28,ACTUAL,2022-12-28,,INTERVENTIONAL,MARBLE,Participants who completed the study.,"Modulating ApoE Signalling to Reduce Brain Inflammation, deLirium and postopErative Cognitive Dysfunction","Modulating ApoE Signalling to Reduce Brain Inflammation, deLirium and postopErative Cognitive Dysfunction (MARBLE): A Phase 2 Trial to Evaluate the Efficacy and Feasibility of CN-105 in Preventing Postoperative Cognitive Dysfunction and Delirium",COMPLETED,,PHASE2,203.0,ACTUAL,Duke University,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 04:29:36.018885,2024-10-17 04:29:36.018885,OTHER,,,,,,,2022,1.0
NCT02270632,,2014-10-16,,,2023-06-09,2014-10-17,2014-10-21,ESTIMATED,,,,,,,2023-06-09,2023-06-12,ACTUAL,2014-10-01,ACTUAL,2014-10-01,2023-06,2023-06-30,2023-06-08,ACTUAL,2023-06-08,2019-04,ACTUAL,2019-04-30,,INTERVENTIONAL,,,"A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate Safety and Clinical Efficacy of Two Different Doses of F8IL10 (Dekavil) Administered Subcutaneously to Patients With Active Rheumatoid Arthritis Receiving Methotrexate.",TERMINATED,,PHASE2,27.0,ACTUAL,Philogen S.p.A.,,3.0,,Approvals of new agents for the same indication have significantly slowed down the recruitment in this trial making the prosecution of the present investigation extremely difficult.,f,,,,f,,,,,,,,,,,,,2024-10-16 07:05:33.558621,2024-10-16 07:05:33.558621,INDUSTRY,,,,,,,2023,0.0
NCT01721772,,2012-11-02,2015-11-20,2015-07-03,2022-06-17,2012-11-02,2012-11-06,ESTIMATED,2016-01-27,2016-02-25,ESTIMATED,2015-07-03,2015-07-28,ESTIMATED,2022-06-17,2022-07-12,ACTUAL,2013-01-18,ACTUAL,2013-01-18,2022-06,2022-06-30,2021-05-14,ACTUAL,2021-05-14,2014-06-24,ACTUAL,2014-06-24,,INTERVENTIONAL,CheckMate 066,All participants randomized to receive treatment,"Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma","A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma",COMPLETED,,PHASE3,418.0,ACTUAL,Bristol-Myers Squibb,An independent data monitoring committee (DMC) found that data from a DMC-requested database lock showed clear survival benefit with nivolumab and thus recommended unblinding the study and switching patients randomized to dacarbazine to nivolumab.,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2021,1.0
NCT04235270,,2020-01-16,,,2020-09-29,2020-01-16,2020-01-21,ACTUAL,,,,,,,2020-09-29,2020-09-30,ACTUAL,2020-01-17,ACTUAL,2020-01-17,2020-09,2020-09-30,2020-07-17,ACTUAL,2020-07-17,2020-07-17,ACTUAL,2020-07-17,,INTERVENTIONAL,,,A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants,"Single-center, Open-label, Single-dose, 2-period, Randomized, Crossover Phase 1 Study to Demonstrate Bioequivalence of Tadalafil Administered as a Fixed Dose Combination Formulation of Macitentan/Tadalafil (10 mg/40 mg) and as the Free Combination of 10 mg Macitentan (Opsumit) and 40 mg Tadalafil (Adcirca), and to Assess the Effect of Food on the Pharmacokinetics of the Fixed Dose Formulation of Macitentan/Tadalafil (10 mg/40 mg) in Healthy Adult Participants",COMPLETED,,PHASE1,62.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,,f,,,,,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 10:01:13.767331,2024-10-15 10:01:13.767331,INDUSTRY,,,,,,,2020,1.0
NCT05738161,,2023-02-09,,,2024-07-03,2023-02-20,2023-02-21,ACTUAL,,,,,,,2024-07-03,2024-07-05,ACTUAL,2023-06-21,ACTUAL,2023-06-21,2024-07,2024-07-31,2024-02-27,ACTUAL,2024-02-27,2024-02-27,ACTUAL,2024-02-27,,INTERVENTIONAL,MACOCUC-01,,Magrolimab in Combination With Cytotoxic Chemotherapy in Advanced Urothelial Carcinoma,"A Phase 1, Single Arm Investigator-initiated Study to Investigate the Safety of Combining the Antibody Magrolimab With Standard First Line Platinum-based Chemotherapy (With Cisplatin / Gemcitabine) in Advanced Urothelial Carcinoma",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Insel Gruppe AG, University Hospital Bern",,1.0,,IMP security Issues reported by Sponsor,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,OTHER,,,,,,,2024,0.0
NCT05652504,,2022-12-14,,,2024-10-15,2022-12-14,2022-12-15,ACTUAL,,,,,,,2024-10-15,2024-10-16,ESTIMATED,2024-10-21,ESTIMATED,2024-10-21,2024-09-26,2024-09-26,2024-11-30,ESTIMATED,2024-11-30,2024-11-30,ESTIMATED,2024-11-30,,INTERVENTIONAL,,,Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1),Phase 1 Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1),SUSPENDED,,PHASE1,400.0,ESTIMATED,National Institutes of Health Clinical Center (CC),,2.0,,The FDA has placed a clinical hold on the IND under which this research is to be conducted.,f,,,,,t,f,,,,,,,,,NO,,2024-10-17 04:29:36.018885,2024-10-17 04:29:36.018885,NIH,,,,,,,2024,0.0
NCT02568215,,2015-10-01,2021-11-30,,2022-02-08,2015-10-01,2015-10-05,ESTIMATED,2022-01-12,2022-02-08,ACTUAL,,,,2022-02-08,2022-02-23,ACTUAL,2016-05,ACTUAL,2016-05-31,2022-02,2022-02-28,2021-03-03,ACTUAL,2021-03-03,2021-03-03,ACTUAL,2021-03-03,,INTERVENTIONAL,,Safety Population,Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women,A Phase 2b Study to Evaluate the Safety and Efficacy of VRC01 Broadly Neutralizing Monoclonal Antibody in Reducing Acquisition of HIV-1 Infection in Women in Sub-Saharan Africa,COMPLETED,,PHASE2,1924.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 18:51:04.168811,2024-10-15 18:51:04.168811,NIH,,,,,,,2021,1.0
NCT02611323,,2015-11-19,2023-07-28,,2023-09-15,2015-11-19,2015-11-20,ESTIMATED,2023-09-15,2023-10-10,ACTUAL,,,,2023-09-15,2023-10-10,ACTUAL,2016-03-09,ACTUAL,2016-03-09,2023-09,2023-09-30,2022-08-04,ACTUAL,2022-08-04,2022-08-04,ACTUAL,2022-08-04,,INTERVENTIONAL,,Safety-evaluable population included all participants who received at least one dose of any component of the combination.,"A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)",A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination With Polatuzumab Vedotin and Venetoclax in Patients With Relapsed or Refractory Follicular Lymphoma and Rituximab in Combination With Polatuzumab Vedotin and Venetoclax in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma,COMPLETED,,PHASE1/PHASE2,133.0,ACTUAL,Hoffmann-La Roche,,4.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2022,1.0
NCT05507996,,2022-08-15,,,2022-11-27,2022-08-18,2022-08-19,ACTUAL,,,,,,,2022-11-27,2022-11-30,ACTUAL,2022-08-18,ACTUAL,2022-08-18,2022-11,2022-11-30,2022-11-23,ACTUAL,2022-11-23,2022-11-23,ACTUAL,2022-11-23,,INTERVENTIONAL,,,Recombinant Adeno-associated Virus Administration for Patients With Menkes Syndrome,An Investigator-initiated Trial Evaluating the Efficacy and Safety of Recombinant Adeno-associated Virus Administration in Patients With Menkes Syndrome,TERMINATED,,EARLY_PHASE1,1.0,ACTUAL,Kunming Hope of Health Hospital,,1.0,,The PI decides to stop.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,OTHER,,,,,,,2022,0.0
NCT04684511,,2020-12-21,,,2022-10-25,2020-12-21,2020-12-24,ACTUAL,,,,,,,2022-10-25,2022-10-27,ACTUAL,2021-06-02,ACTUAL,2021-06-02,2022-08,2022-08-31,2022-09-28,ACTUAL,2022-09-28,2022-09-28,ACTUAL,2022-09-28,,INTERVENTIONAL,RESET-HA,,Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy,"A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Study With a Long-Term, Open-Label Extension to Evaluate the Efficacy and Safety of TRM-201 (Rofecoxib) in Patients With Hemophilic Arthropathy",TERMINATED,,PHASE3,2.0,ACTUAL,"Tremeau Pharmceuticals, Inc.",,2.0,,Low enrollment. The termination of the trial was not based on any safety concerns in the study.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2022,0.0
NCT04743011,,2021-02-03,2022-11-06,,2024-10-06,2021-02-05,2021-02-08,ACTUAL,2024-10-06,2024-10-15,ACTUAL,,,,2024-10-06,2024-10-15,ACTUAL,2021-06-01,ACTUAL,2021-06-01,2024-10,2024-10-31,2021-12-31,ACTUAL,2021-12-31,2021-11-30,ACTUAL,2021-11-30,,INTERVENTIONAL,EnHanCed,,Enriched Heparin Anti COVID-19 Trial,Nebulized Enriched Heparin to Treat no Critical Patients With Sars-Cov-2 - Triple Blind Clinical Trial,COMPLETED,,PHASE1/PHASE2,27.0,ACTUAL,UPECLIN HC FM Botucatu Unesp,,2.0,,,f,,,,t,f,f,,,,,,The summary data will be published or made available 6 months after publication.,"Epidemiological data, clinical data, and patient evolution will be shared during the study only for researchers who request access to the data. Access requests will be analyzed by the main researcher, and they will only be released for scientific purposes.",,YES,There is a plan to make IPD and related data dictionaries available,2024-10-17 04:29:36.018885,2024-10-17 04:29:36.018885,OTHER,,,,,,,2021,1.0
NCT03653364,,2018-08-29,2024-03-28,,2024-05-13,2018-08-29,2018-08-31,ACTUAL,2024-05-13,2024-05-17,ACTUAL,,,,2024-05-13,2024-05-17,ACTUAL,2019-01-23,ACTUAL,2019-01-23,2024-05,2024-05-31,2023-04-03,ACTUAL,2023-04-03,2023-04-03,ACTUAL,2023-04-03,,INTERVENTIONAL,,Safety-evaluable population included all participants who received at least one dose of treatment regardless of whether they had any follow-up assessments.,"Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms","A Multicenter, Single-Arm, Open-Label Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients From Birth to < 1 Year With Influenza-Like Symptoms",COMPLETED,,PHASE3,49.0,ACTUAL,Hoffmann-La Roche,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 18:51:04.168811,2024-10-15 18:51:04.168811,INDUSTRY,,,,,,,2023,1.0
NCT03925428,,2019-04-23,,,2020-09-25,2019-04-23,2019-04-24,ACTUAL,,,,,,,2020-09-25,2020-09-28,ACTUAL,2020-09-18,ACTUAL,2020-09-18,2020-09,2020-09-30,2020-09-18,ACTUAL,2020-09-18,2020-09-18,ACTUAL,2020-09-18,,INTERVENTIONAL,,,"Testing a New Anti-cancer Drug Combination, Entinostat and GSK525762C, for Advanced and Refractory Solid Tumors and Lymphomas",Phase I Study of GSK525762C and Entinostat in Advanced and Refractory Solid Tumors and Lymphomas,WITHDRAWN,,PHASE1,0.0,ACTUAL,National Cancer Institute (NCI),,1.0,,Other - Protocol moved to Disapproved,,,,,t,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.",2024-10-16 07:05:33.558621,2024-10-16 07:05:33.558621,NIH,,,,,,,2020,0.0
NCT04860466,,2021-04-22,,,2024-10-14,2021-04-22,2021-04-27,ACTUAL,,,,,,,2024-10-14,2024-10-16,ESTIMATED,2022-01-20,ACTUAL,2022-01-20,2024-09,2024-09-30,2024-07-31,ACTUAL,2024-07-31,2024-07-31,ACTUAL,2024-07-31,,INTERVENTIONAL,,,A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma,"A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma",TERMINATED,,PHASE1,9.0,ACTUAL,Celgene,,1.0,,Business objectives have changed.,f,,,,f,t,f,,,,,,See Plan Description,See Plan Description,https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,2024-10-17 04:29:36.018885,2024-10-17 04:29:36.018885,INDUSTRY,,,,,,,2024,0.0
NCT03706521,,2018-10-11,,2021-07-12,2021-11-15,2018-10-11,2018-10-16,ACTUAL,,,,2021-07-12,2021-07-16,ACTUAL,2021-11-15,2021-11-17,ACTUAL,2019-03-11,ACTUAL,2019-03-11,2021-11,2021-11-30,2020-12-21,ACTUAL,2020-12-21,2020-07-22,ACTUAL,2020-07-22,,INTERVENTIONAL,,,A Study Utilizing Imaging Techniques and Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis,"A Phase 2, 52 Week, Single Center, Open-Label Study Utilizing Imaging Techniques and Evaluating the Safety and Efficacy of SM04690 Injectable Suspension for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis",TERMINATED,,PHASE2,13.0,ACTUAL,"Biosplice Therapeutics, Inc.",,1.0,,The study was terminated early due to COVID-19-related issues.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:51:04.168811,2024-10-15 18:51:04.168811,INDUSTRY,,,,,,,2020,0.0
NCT05651633,,2022-11-09,,,2024-05-09,2022-12-06,2022-12-15,ACTUAL,,,,,,,2024-05-09,2024-05-13,ACTUAL,2021-10-06,ACTUAL,2021-10-06,2024-05,2024-05-31,2024-01-10,ACTUAL,2024-01-10,2023-12-16,ACTUAL,2023-12-16,,INTERVENTIONAL,OPTIMA,,Analgesic Ear Drops for Children With Acute Otitis Media,Effectiveness of Analgesic Ear Drops as add-on Treatment to Oral Analgesics in Children With Acute Otitis Media: a Pragmatic Randomised Controlled Trial,TERMINATED,,PHASE3,29.0,ACTUAL,UMC Utrecht,,2.0,,Trial accrual problems,f,,,,f,f,f,,,,,,,,,YES,"On completion of the trial, data will be stored for a minimum of 25 years at a central data drive at the Julius Center. The investigators will publish the metadata in the DataverseNL repository and will provide a persistent identifier. The data will be available to researchers who provide a methodologicaly sound proposal to achieve the aims in the approved proposal. Proposals to gain access to the data should be directed to the principle investigator (RPV). Data requestors will need to sign a data sharing agreement.",2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,OTHER,,,,,,,2024,0.0
NCT03450629,,2018-02-21,2021-11-30,,2022-01-27,2018-02-28,2018-03-01,ACTUAL,2022-01-27,2022-02-15,ACTUAL,,,,2022-01-27,2022-02-15,ACTUAL,2018-09-13,ACTUAL,2018-09-13,2022-01,2022-01-31,2020-12-01,ACTUAL,2020-12-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,,Safety Population,Evaluation of Safety and Efficacy of PDP-716,"A Randomized, Multi-Center, Investigator-Masked, Parallel Group, Equivalence Study of Once Daily Brimonidine Tartrate Ophthalmic Suspension Compared With Three Times Daily ALPHAGAN-P® in Subjects With Open Angle Glaucoma, or Ocular Hypertension",COMPLETED,,PHASE3,682.0,ACTUAL,Sun Pharma Advanced Research Company Limited,,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2020,1.0
NCT04418167,,2020-05-11,,,2024-02-01,2020-06-02,2020-06-05,ACTUAL,,,,,,,2024-02-01,2024-02-02,ACTUAL,2020-06-18,ACTUAL,2020-06-18,2023-09,2023-09-30,2024-12-17,ESTIMATED,2024-12-17,2024-06-30,ESTIMATED,2024-06-30,,INTERVENTIONAL,,,JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations,A Phase 1 Study of ERK1/2 Inhibitor JSI-1187 Administered as Monotherapy and in Combination With Dabrafenib for the Treatment of Advanced Solid Tumors With MAPK Pathway Mutations,SUSPENDED,,PHASE1,71.0,ACTUAL,"JS InnoPharm, LLC",,3.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2024,0.0
NCT02891850,,2016-08-26,2021-01-04,,2021-02-03,2016-09-01,2016-09-08,ESTIMATED,2021-01-04,2021-01-22,ACTUAL,,,,2021-02-03,2021-02-26,ACTUAL,2017-01-11,ACTUAL,2017-01-11,2021-01,2021-01-31,2020-03-03,ACTUAL,2020-03-03,2020-01-29,ACTUAL,2020-01-29,,INTERVENTIONAL,REPLACE,,Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy,"A Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment Goal",COMPLETED,,PHASE4,225.0,ACTUAL,Bayer,,2.0,,,f,,,,f,,f,,,,,,,,,,,2024-10-15 10:01:13.767331,2024-10-15 10:01:13.767331,INDUSTRY,,,,,,,2020,1.0
NCT03879538,,2019-01-31,2023-12-11,,2024-02-07,2019-03-15,2019-03-18,ACTUAL,2024-02-07,2024-02-09,ACTUAL,,,,2024-02-07,2024-02-09,ACTUAL,2019-07-02,ACTUAL,2019-07-02,2024-02,2024-02-29,2022-07-28,ACTUAL,2022-07-28,2022-07-28,ACTUAL,2022-07-28,,INTERVENTIONAL,,,Nitrous Oxide for the Treatment of Complex Regional Pain Syndrome,A Prospective Randomized Controlled Pilot Study Nitrous Oxide for the Treatment of Complex Regional Pain Syndrome,COMPLETED,,PHASE3,44.0,ACTUAL,The Cleveland Clinic,"limitations include the purely subjective nature of pain which was our primary outcome. Validity of the trial thus depends critically on adequacy of blinding. Because many patients can detect inhaled nitrous oxide, we gave all participants midazolam which has similar effects. But it remains possible that some patients could distinguish nitrous oxide from air, and were thus biased.",2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,OTHER,,,,,,,2022,1.0
NCT03972046,,2019-05-31,,,2020-10-14,2019-05-31,2019-06-03,ACTUAL,,,,,,,2020-10-14,2020-10-19,ACTUAL,2019-06-24,ACTUAL,2019-06-24,2020-02,2020-02-29,2020-02-03,ACTUAL,2020-02-03,2020-02-03,ACTUAL,2020-02-03,,INTERVENTIONAL,,,Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma,Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma: A Pilot Study,WITHDRAWN,,PHASE2,0.0,ACTUAL,TriHealth Inc.,,1.0,,Principal investigator leaving study site; no replacement PI will be sought,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,OTHER,,,,,,,2020,0.0
NCT02130557,,2014-05-01,2018-07-13,,2021-04-16,2014-05-02,2014-05-05,ESTIMATED,2018-10-15,2018-11-14,ACTUAL,,,,2021-04-16,2021-05-18,ACTUAL,2014-07-15,ACTUAL,2014-07-15,2021-04,2021-04-30,2020-04-17,ACTUAL,2020-04-17,2016-08-11,ACTUAL,2016-08-11,,INTERVENTIONAL,,Intent-to-treat population: All randomized participants with study drug assignments designated according to initial randomization.,"A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia","A MULTICENTER PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA",COMPLETED,,PHASE3,536.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,,,,,,2020,1.0
NCT05604755,,2022-10-30,,,2023-01-16,2022-10-30,2022-11-03,ACTUAL,,,,,,,2023-01-16,2023-01-18,ACTUAL,2022-01-01,ACTUAL,2022-01-01,2023-01,2023-01-31,2024-12-30,ESTIMATED,2024-12-30,2023-12-30,ESTIMATED,2023-12-30,,INTERVENTIONAL,Case-Only,,Prophylactic HQP1351 Therapy Post-transplants on Leukemia After Allo-HSCT,Effect of Prophylactic HQP1351 Maintenance Post-transplants on Ph+ Luekemia Undergoing Allo-HSCT With MRD Positive Pre-transplants,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Nanfang Hospital, Southern Medical University",,1.0,,Drugs was too expensive eligible for inclusion,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,OTHER,,,,,,,2024,0.0
NCT04359017,,2020-04-17,,,2023-12-11,2020-04-20,2020-04-24,ACTUAL,,,,,,,2023-12-11,2023-12-18,ACTUAL,2020-11-01,ACTUAL,2020-11-01,2023-12,2023-12-31,2023-12-01,ACTUAL,2023-12-01,2023-12-01,ACTUAL,2023-12-01,,INTERVENTIONAL,,,Systemic Absorption of Lidocaine After Hematoma Block,Systemic Absorption of Lidocaine After Ultrasound Guided Hematoma Block for Reduction of Different Types of Pediatric Distal Radius Fractures,WITHDRAWN,,PHASE4,0.0,ACTUAL,Washington University School of Medicine,,1.0,,Sponsoring staff have left institution,f,,,,,f,f,,,f,,,,,,NO,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,OTHER,,,,,,,2023,0.0
NCT03861052,,2019-03-01,2022-03-04,,2022-04-13,2019-03-01,2019-03-04,ACTUAL,2022-04-13,2022-04-14,ACTUAL,,,,2022-04-13,2022-04-14,ACTUAL,2019-05-07,ACTUAL,2019-05-07,2022-04,2022-04-30,2021-03-31,ACTUAL,2021-03-31,2021-03-10,ACTUAL,2021-03-10,,INTERVENTIONAL,SURPASS J-mono,All participants who received at least one dose of study drug.,A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 Diabetes,A Phase 3 Study of Tirzepatide Monotherapy Compared to Dulaglutide 0.75 mg in Patients With Type 2 Diabetes Mellitus,COMPLETED,,PHASE3,636.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,f,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://www.clinicalstudydatarequest.com,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,,,,,,2021,1.0
NCT02620306,,2015-12-01,,,2022-05-24,2015-12-02,2015-12-03,ESTIMATED,,,,,,,2022-05-24,2022-05-25,ACTUAL,2016-02-11,ACTUAL,2016-02-11,2021-05,2021-05-31,2022-05-11,ACTUAL,2022-05-11,2019-12-23,ACTUAL,2019-12-23,,INTERVENTIONAL,,,"A Randomized, Double-blind, Active Control, Parallel Group, Titration, Multicenter Study to Evaluate the Efficacy and Safety of Fimasartan",,COMPLETED,,PHASE3,351.0,ACTUAL,"Boryung Pharmaceutical Co., Ltd",,4.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,,,,,,2022,1.0
NCT04797975,,2021-03-12,,,2021-08-24,2021-03-12,2021-03-15,ACTUAL,,,,,,,2021-08-24,2021-08-30,ACTUAL,2020-12,ESTIMATED,2020-12-31,2021-03,2021-03-31,2021-04,ESTIMATED,2021-04-30,2021-04,ESTIMATED,2021-04-30,,INTERVENTIONAL,,,Off-the-shelf NK Cells (KDS-1000) as Immunotherapy for COVID-19,A Phase 1/2a Multicenter Randomized Double-blind Placebo-controlled Trial of Off-the-shelf Natural Killer Cells (KDS-1000) as Immunotherapy for Adult Patients With Mild to Moderate COVID-19 Symptoms at Risk for Complications,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Kiadis Pharma,,2.0,,The sponsor decided to withdraw this study,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 07:05:33.558621,2024-10-16 07:05:33.558621,INDUSTRY,,,,,,,2021,0.0
NCT04435015,,2020-06-16,,,2022-05-11,2020-06-16,2020-06-17,ACTUAL,,,,,,,2022-05-11,2022-05-18,ACTUAL,2021-11,ESTIMATED,2021-11-30,2022-05,2022-05-31,2021-12-31,ESTIMATED,2021-12-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,The Utility of Camostat Mesylate in Patients With COVID-19 Associated Coagulopathy (CAC) and Cardiovascular Complications,The Utility of Camostat Mesylate in Patients With COVID-19 Associated Coagulopathy (CAC) and Cardiovascular Complications,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Yale University,,2.0,,No funding,f,,,,t,t,f,,,,,,Study protocol and clinical study report will be shared 1 year after completion of the study,,,YES,,2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,OTHER,,,,,,,2021,0.0
NCT02966587,,2016-11-15,,,2018-01-12,2016-11-15,2016-11-17,ESTIMATED,,,,,,,2018-01-12,2018-01-17,ACTUAL,2018-05-15,ESTIMATED,2018-05-15,2018-01,2018-01-31,2023-05-15,ESTIMATED,2023-05-15,2023-05-15,ESTIMATED,2023-05-15,,INTERVENTIONAL,,,Durvalumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer,Durvalumab (MEDI4736) in Hypermutated Metastatic Castration-Resistant Prostate Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Washington,,1.0,,Withdrawn prior to opening to enrollment,f,,,,t,t,f,,,,,,,,,,,2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,OTHER,,,,,,,2023,0.0
NCT04759833,,2021-02-16,2024-05-10,,2024-05-10,2021-02-16,2021-02-18,ACTUAL,2024-05-10,2024-06-06,ACTUAL,,,,2024-05-10,2024-06-06,ACTUAL,2021-07-13,ACTUAL,2021-07-13,2024-05,2024-05-31,2023-11-13,ACTUAL,2023-11-13,2023-11-13,ACTUAL,2023-11-13,,INTERVENTIONAL,,"For Part A, the Safety Analysis Set included all participants who received at least 1 dose of study drug in Part A.",A Study of Prucalopride For Functional Constipation in Children and Teenagers,"Phase 3, Multicenter, Randomized Study With 2 Different Doses of Prucalopride Administered to Male and Female Pediatric Subjects Aged 6 Months to 17 Years With Functional Constipation, Consisting of a 12-week Double-blind, Placebo-controlled Part (Part A) to Evaluate Efficacy and Safety Followed by a 36-week Double-blind Extension Part (Part B) to Document Long-term Safety up to Week 48",TERMINATED,,PHASE3,175.0,ACTUAL,Takeda,,5.0,,"Data Monitoring Committee (DMC) decision; terminated due to futility, with no safety concerns; FDA agreement to terminate the study.",f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,,,,,,2023,0.0
NCT02884245,,2016-08-22,,,2023-02-07,2016-08-25,2016-08-30,ESTIMATED,,,,,,,2023-02-07,2023-02-08,ACTUAL,2016-11-04,ACTUAL,2016-11-04,2023-02,2023-02-28,2023-01-04,ACTUAL,2023-01-04,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,PRESCORI,,Interest of Estrogen Scheduling Before Ovarian Stimulation With Corifollitropin Alfa,Interest of Estrogen Scheduling Before Ovarian Stimulation With Corifollitropin Alfa in Women Older Than 38 Years Old Undergoing in Vitro Fertilization,COMPLETED,,PHASE3,334.0,ACTUAL,Centre Hospitalier Intercommunal Creteil,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,OTHER,,,,,,,2023,0.0
NCT04941703,,2021-06-24,2023-06-15,,2023-11-08,2021-06-24,2021-06-28,ACTUAL,2023-11-08,2023-11-13,ACTUAL,,,,2023-11-08,2023-11-13,ACTUAL,2021-11-04,ACTUAL,2021-11-04,2023-11,2023-11-30,2022-06-25,ACTUAL,2022-06-25,2022-06-25,ACTUAL,2022-06-25,,INTERVENTIONAL,CHANGE,In additional to reporting data for the full trial population we will also report data separately for patients randomized in the ICU (who tend to be more severely ill) and those randomized outside the ICU (who tend to be less severely ill) as well as those with duration of symptoms ≤5 days prior to randomization and those with \>5 days of symptoms prior to randomization.,CHANGE COVID-19 Severity,Investigation of Choice Alteration of the Gut Metagenome on COVID-19 Severity,TERMINATED,,PHASE1/PHASE2,23.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,Recruitment issues after COVID-19 abated; not enough hypoxic patients to meet criteria.,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,OTHER,,,,,,,2022,0.0
NCT03931291,,2019-04-26,2024-02-27,,2024-04-19,2019-04-26,2019-04-30,ACTUAL,2024-02-27,2024-03-26,ACTUAL,,,,2024-04-19,2024-04-25,ACTUAL,2019-09-16,ACTUAL,2019-09-16,2024-04,2024-04-30,2022-01-14,ACTUAL,2022-01-14,2021-08-27,ACTUAL,2021-08-27,,INTERVENTIONAL,,,APR-246 in Combination With Azacitidine for TP53 Mutated AML (Acute Myeloid Leukemia) or MDS (Myelodysplastic Syndromes) Following Allogeneic Stem Cell Transplant,Phase II Trial of APR-246 in Combination With Azacitidine as Maintenance Therapy for TP53 Mutated AML or MDS Following Allogeneic Stem Cell Transplant,COMPLETED,,PHASE2,33.0,ACTUAL,Aprea Therapeutics,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,INDUSTRY,,,,,,,2022,1.0
NCT04715763,,2021-01-14,,,2022-06-27,2021-01-14,2021-01-20,ACTUAL,,,,,,,2022-06-27,2022-07-01,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2022-06,2022-06-30,2022-04-26,ACTUAL,2022-04-26,2022-04-26,ACTUAL,2022-04-26,,INTERVENTIONAL,INTEL,,INvestigating TELmisartin Study,"Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Treatment of COVID-19 in Hospitalized Patients",TERMINATED,,PHASE2,24.0,ACTUAL,University of Hawaii,,2.0,,Poor recruitment due to decrease in COVID-19 rates locally,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,OTHER,,,,,,,2022,0.0
NCT03905512,,2019-04-01,2023-08-24,2021-08-04,2023-09-26,2019-04-04,2019-04-05,ACTUAL,2023-09-26,2023-10-17,ACTUAL,,2023-10-17,ACTUAL,2023-09-26,2023-10-17,ACTUAL,2019-05-07,ACTUAL,2019-05-07,2023-09,2023-09-30,2020-08-05,ACTUAL,2020-08-05,2020-08-05,ACTUAL,2020-08-05,,INTERVENTIONAL,COMPARE,The Intent-to-Treat (ITT) set included all randomized participants.,A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy,A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy,COMPLETED,,PHASE2,170.0,ACTUAL,"Selecta Biosciences, Inc.",,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,,,,,,2020,1.0
NCT03451695,,2018-02-20,,,2021-04-04,2018-02-25,2018-03-02,ACTUAL,,,,,,,2021-04-04,2021-04-06,ACTUAL,2018-04-01,ACTUAL,2018-04-01,2021-04,2021-04-30,2021-03-30,ACTUAL,2021-03-30,2020-12-26,ACTUAL,2020-12-26,,INTERVENTIONAL,,,Effect of Intrathecal Morphine on Chronic Pain After Elective Caesarean Section,Effect of Intrathecal Morphine on Chronic Pain After Elective Caesarean Section: A Randomized Controlled Trial.,COMPLETED,,PHASE4,290.0,ACTUAL,B.P. Koirala Institute of Health Sciences,,2.0,,,f,,,,f,f,f,,,,,,The final research data and study protocol will be shared with the journal accepting the article for publication. It will be available simultaneously after publication of the article.,The IPD may be accessed from the link provided in the published manuscript The IPD may also be shared to other researchers by the investigators upon request,https://data.mendeley.com/,YES,The final research data will be stored in Mendeley. The final data will be released and shared during the publication process of the manuscript.,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,OTHER,,,,,,,2021,0.0
NCT02148705,,2014-05-22,2022-12-15,,2024-07-08,2014-05-27,2014-05-28,ESTIMATED,2023-06-11,2023-06-27,ACTUAL,,,,2024-07-08,2024-07-10,ACTUAL,2015-05-27,ACTUAL,2015-05-27,2023-06,2023-06-30,2020-08-20,ACTUAL,2020-08-20,2018-06-12,ACTUAL,2018-06-12,,INTERVENTIONAL,,"Overall 175 randomized patients are the baseline participants (Full Analysis Set, FAS). Out of the 175, 169 were treated (safety population): 77 In NexoBrid Gel arm, 24 In Gel Vehicle arm (Placebo) and 68 in the SOC arm.",A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns,"A Multicenter, Multinational, Randomized, Controlled, Assessor Blinded Study, Performed in Subjects With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid Compared to Gel Vehicle and Compared to Standard of Care",COMPLETED,,PHASE3,175.0,ACTUAL,MediWound Ltd,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,,,,,,2020,1.0
NCT02816762,,2016-05-31,,,2021-05-10,2016-06-24,2016-06-29,ESTIMATED,,,,,,,2021-05-10,2021-05-11,ACTUAL,2016-06,,2016-06-30,2021-05,2021-05-31,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,DIANA,,CPAP Effect on Albuminuria in Patients With Diabetic Nephropathy and Obstructive Sleep Apnea,Effect of Continuous Positive Airway Pressure on Albuminuria in Patients With Diabetic Nephropathy and Obstructive Sleep Apnea,COMPLETED,,PHASE4,180.0,ESTIMATED,Hospital Universitario La Paz,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 07:05:33.558621,2024-10-16 07:05:33.558621,OTHER,,,,,,,2020,0.0
NCT03614663,,2018-07-10,2022-02-09,,2022-06-15,2018-08-02,2018-08-03,ACTUAL,2022-05-20,2022-06-16,ACTUAL,,,,2022-06-15,2022-07-06,ACTUAL,2018-06-12,ACTUAL,2018-06-12,2020-07,2020-07-31,2020-06-14,ACTUAL,2020-06-14,2020-06-14,ACTUAL,2020-06-14,,INTERVENTIONAL,CONNECT-FX,,Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX),"A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With Fragile X Syndrome",COMPLETED,,PHASE2/PHASE3,212.0,ACTUAL,"Zynerba Pharmaceuticals, Inc.",,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,,,,,,2020,1.0
NCT04210037,,2019-12-20,,,2022-07-08,2019-12-23,2019-12-24,ACTUAL,,,,,,,2022-07-08,2022-07-12,ACTUAL,2020-08-20,ACTUAL,2020-08-20,2022-07,2022-07-31,2022-05-15,ACTUAL,2022-05-15,2021-08-30,ACTUAL,2021-08-30,,INTERVENTIONAL,,,Study of APG-1252 Plus Paclitaxel in Patients With Relapsed/Refractory Small Cell Lung Cancer,"A Multi-Center, Phase Ib/II Study of Combination Treatment of APG-1252 With Paclitaxel in Patients With Relapsed/Refractory Small Cell Lung Cancer",TERMINATED,,PHASE1/PHASE2,28.0,ACTUAL,Ascentage Pharma Group Inc.,,3.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,,,,,,2022,0.0
NCT04501666,,2020-07-30,2024-05-16,2023-11-02,2024-07-04,2020-08-05,2020-08-06,ACTUAL,2024-07-04,2024-07-10,ACTUAL,,2024-07-10,ACTUAL,2024-07-04,2024-07-10,ACTUAL,2020-09-11,ACTUAL,2020-09-11,2024-07,2024-07-31,2023-02-21,ACTUAL,2023-02-21,2022-11-11,ACTUAL,2022-11-11,,INTERVENTIONAL,,Analysis was performed on intent-to-treat population (ITT) population which consisted of all randomized participants.,Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN),"A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis",COMPLETED,,PHASE3,286.0,ACTUAL,Galderma R&D,,2.0,,,f,,,,t,t,f,,,,,,Data availability will begin 6 months after approval of the indication by a regulatory body.~Data availability will end 5 years from publication of the primary study results article.,Data will be made available to qualified science and medical researchers upon formal request and submission of research proposal detailing planned analyses. Proposals should be directed to clinical.studies@galderma.com,,YES,Qualified researchers may request access to anonymized data sets from which results presented are derived.,2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,INDUSTRY,,,,,,,2023,1.0
NCT03199586,,2017-06-23,,,2020-12-21,2017-06-26,2017-06-27,ACTUAL,,,,,,,2020-12-21,2020-12-22,ACTUAL,2017-12-21,ACTUAL,2017-12-21,2020-12,2020-12-31,2020-05-07,ACTUAL,2020-05-07,2020-05-07,ACTUAL,2020-05-07,,INTERVENTIONAL,,,Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Treatment-Refractory Solid Tumor Malignancies,"First-in-Human, Dose Finding, Open Label Phase 1A-1B Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Treatment-Refractory Solid Tumor Malignancies",COMPLETED,,PHASE1,23.0,ACTUAL,"Novita Pharmaceuticals, Inc.",,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,INDUSTRY,,,,,,,2020,1.0
NCT02707666,,2016-02-29,,,2024-07-29,2016-03-11,2016-03-14,ESTIMATED,,,,,,,2024-07-29,2024-07-31,ACTUAL,2016-02-25,ACTUAL,2016-02-25,2024-07,2024-07-31,2023-04-24,ACTUAL,2023-04-24,2023-04-24,ACTUAL,2023-04-24,,INTERVENTIONAL,,,A Pilot Window-Of-Opportunity Study of the Anti-PD-1 Antibody Pembrolizumab in Patients With Resectable Malignant Pleural Mesothelioma,A Pilot Window-of-opportunity Study of the Anti-PD-1 Antibody Pembrolizumab in Patients With Resectable Malignant Pleural Mesothelioma,TERMINATED,,PHASE1,7.0,ACTUAL,University of Chicago,,1.0,,unable to complete enrollment,f,,,,f,t,f,,,,,,,,,,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,OTHER,,,,,,,2023,0.0
NCT02252042,,2014-09-25,2018-05-04,,2023-06-30,2014-09-25,2014-09-29,ESTIMATED,2018-08-10,2018-08-13,ACTUAL,,,,2023-06-30,2023-07-17,ACTUAL,2014-11-17,ACTUAL,2014-11-17,2023-06,2023-06-30,2022-08-15,ACTUAL,2022-08-15,2017-05-15,ACTUAL,2017-05-15,,INTERVENTIONAL,,,Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040),A Phase III Randomized Trial of MK-3475 (Pembrolizumab) Versus Standard Treatment in Subjects With Recurrent or Metastatic Head and Neck Cancer,COMPLETED,,PHASE3,495.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,,,,,,2022,1.0
NCT01318161,,2011-03-17,,,2021-02-15,2011-03-17,2011-03-18,ESTIMATED,,,,,,,2021-02-15,2021-02-16,ACTUAL,2011-03,,2011-03-31,2021-02,2021-02-28,2021-01,ACTUAL,2021-01-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,EPICOL,,Epidural Versus Patient-controlled Analgesia for Reduction in Long-term Mortality Following Colorectal Cancer Surgery,Epidural or Patient-controlled Analgesia for Colorectal Cancer Surgery. Long-term Outcomes.,TERMINATED,,PHASE3,221.0,ACTUAL,"Örebro University, Sweden",,2.0,,Difficulty in recruiting,f,,,,t,,,,,,,,,,,,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,OTHER,,,,,,,2021,0.0
NCT04158687,,2019-11-07,2023-12-07,2021-12-13,2023-12-07,2019-11-07,2019-11-12,ACTUAL,2023-12-07,2023-12-22,ACTUAL,2021-12-13,2021-12-17,ACTUAL,2023-12-07,2023-12-22,ACTUAL,2019-11-26,ACTUAL,2019-11-26,2023-12,2023-12-31,2020-12-22,ACTUAL,2020-12-22,2020-12-22,ACTUAL,2020-12-22,,INTERVENTIONAL,,Safety population included all participants who received at least one dose of study medication.,A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia,"A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adult Patients With Schizophrenia",COMPLETED,,PHASE2,326.0,ACTUAL,Concert Pharmaceuticals,,4.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2020,1.0
NCT04220775,,2019-11-26,2023-09-01,,2024-07-02,2020-01-04,2020-01-07,ACTUAL,2024-07-02,2024-07-23,ACTUAL,,,,2024-07-02,2024-07-23,ACTUAL,2020-03-18,ACTUAL,2020-03-18,2024-07,2024-07-31,2022-10-03,ACTUAL,2022-10-03,2022-10-03,ACTUAL,2022-10-03,,INTERVENTIONAL,,,Bintrafusp Alfa and Stereotactic Body Radiation Therapy for the Treatment of Recurrent or Second Primary Head and Neck Squamous Cell Cancer,Phase I/II Study of M7824 Plus Curative Intent Re-Irradiation With Stereotactic Body Radiation Therapy (SBRT) in Patients With Local-Regionally Recurrent Head and Neck Squamous Cell Carcinoma,TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,The sponsor decided to no longer develop the drug and stop support of studies using the drug.,,,,,f,t,f,,,,,,,,,,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,OTHER,,,,,,,2022,0.0
NCT03959384,,2019-04-09,,,2021-04-12,2019-05-20,2019-05-22,ACTUAL,,,,,,,2021-04-12,2021-04-15,ACTUAL,2019-01-09,ACTUAL,2019-01-09,2021-04,2021-04-30,2021-04-09,ACTUAL,2021-04-09,2021-04-09,ACTUAL,2021-04-09,,INTERVENTIONAL,,,Efficacy and Safety of Curosurf® in Patients Invasively Ventilated for Severe Bronchiolitis Under 12 Months of Age,"Efficacy and Safety of Curosurf® in Patients Under 12 Months of Age Requiring Invasive Mechanical Ventilation for Acute Respiratory Distress Syndrome in the Course of Bronchiolitis: A Randomized, Double-blind, Placebo-controlled Trial",TERMINATED,,PHASE3,9.0,ACTUAL,Azienda Ospedaliera Universitaria Integrata Verona,,2.0,,"Due to COVID19 hospital admissions by patients with moderate-severe bronchiolitis have drastically decreased from 02/2020 to date. Moreover, many centers that had initially joined the study project had great difficulties in the activation phase",f,,,,t,f,f,,,,,,"Data will be available within 9 months of study completion, up to five years",Data access request will be reviewed by the Steering committee. Requestors wil be required to sign a Data Access Agreement,,YES,De-identified individual participant data for all primary and secondary outcome measures will be made available,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,OTHER,,,,,,,2021,0.0
NCT03514836,,2018-04-11,,,2021-01-27,2018-05-01,2018-05-02,ACTUAL,,,,,,,2021-01-27,2021-02-01,ACTUAL,2018-05-23,ACTUAL,2018-05-23,2021-01,2021-01-31,2021-01-25,ACTUAL,2021-01-25,2021-01-25,ACTUAL,2021-01-25,,INTERVENTIONAL,,,"A Phase I/II, Safety Clinical Trial of DCVAC/PCa and ONCOS-102 in Men With Metastatic Castration-resistant Prostate Cancer","A Phase I/II, Clinical Trial to Evaluate the Safety and Immune Activation of the Combination of DCVAC/PCa, and ONCOS-102, in Men With Advanced Metastatic Castration-resistant Prostate Cancer.",TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,Sotio Biotech Inc.,,1.0,,insufficient accrual,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,,,,,,2021,0.0
NCT02772081,,2016-05-06,2023-08-11,,2023-11-02,2016-05-11,2016-05-13,ESTIMATED,2023-10-12,2023-11-03,ACTUAL,,,,2023-11-02,2023-11-07,ACTUAL,2021-05-18,ACTUAL,2021-05-18,2023-11,2023-11-30,2022-08-13,ACTUAL,2022-08-13,2022-08-13,ACTUAL,2022-08-13,,INTERVENTIONAL,LISPAP,Intention to treat (ITT),A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration,"An Open-Label, Multicenter, Randomized, Controlled Study in Spontaneously Breathing Preterm Neonates With Respiratory Distress Syndrome to Compare Two Procedures for Porcine Surfactant (Poractant Alfa, CUROSURF®) Administration: A Less Invasive Method (LISA) During Non-invasive Ventilation (NIV) and the Conventional Administration During Brief Invasive Ventilation.",TERMINATED,,PHASE3,33.0,ACTUAL,Chiesi Farmaceutici S.p.A.,"The Sponsor issued an early notification of an immediate enrolment hold to participating study sites (01 June 2022) and an official notification (05 July 2022) after identifying uncertain availability of the CHF 6440 catheter. Because the availability of CHF 6440 catheter to all participating study sites could not be assured, the Sponsor decided to terminate the study early.",2.0,,Sponsor decision,f,,,,t,t,t,t,,,,,,,,NO,,2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,INDUSTRY,,,,,,,2022,0.0
NCT03402789,,2018-01-11,,,2024-02-07,2018-01-11,2018-01-18,ACTUAL,,,,,,,2024-02-07,2024-02-09,ACTUAL,2024-01-01,ESTIMATED,2024-01-01,2024-02,2024-02-29,2024-12-30,ESTIMATED,2024-12-30,2024-07-01,ESTIMATED,2024-07-01,,INTERVENTIONAL,,,Docosahexaenoic Acid (DHA) Supplementation in Amblyopia,Pilot Study to Evaluate Docosahexaenoic Acid as Treatment for Residual Amblyopia,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Johns Hopkins University,,2.0,,"Hopkins failed to review contract with company providing complimentary dha, support was withdrawn necessitating me to get more grant money to fund study which was unsucccessful.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,OTHER,,,,,,,2024,0.0
NCT03540160,,2018-04-05,2020-10-28,,2021-05-18,2018-05-26,2018-05-30,ACTUAL,2020-11-26,2020-11-30,ACTUAL,,,,2021-05-18,2021-05-20,ACTUAL,2018-03-15,ACTUAL,2018-03-15,2021-05,2021-05-31,2020-06-17,ACTUAL,2020-06-17,2020-04-08,ACTUAL,2020-04-08,,INTERVENTIONAL,,Nine subjects were excluded from the safety population (all from US) due to no evidence of subject dosing and/or no post-Baseline assessment/treatment emergent adverse event.,Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch),An Open-Label Long-Term Safety Study of Serlopitant for the Treatment of Pruritus,TERMINATED,,PHASE3,558.0,ACTUAL,Vyne Therapeutics Inc.,"Due to a corporate decision to no longer pursue an indication of treatment for pruritus, and further to terminate the development program for serlopitant, the study was terminated prematurely.",1.0,,No longer pursuing development of serlopitant,f,,,,f,t,f,,,,,,,,,,,2024-10-16 16:56:34.979395,2024-10-16 16:56:34.979395,INDUSTRY,,,,,,,2020,0.0
NCT05079126,,2021-10-04,,,2022-08-08,2021-10-04,2021-10-15,ACTUAL,,,,,,,2022-08-08,2022-08-10,ACTUAL,2021-12-02,ACTUAL,2021-12-02,2022-08,2022-08-31,2022-05-27,ACTUAL,2022-05-27,2022-05-25,ACTUAL,2022-05-25,,INTERVENTIONAL,ILD-DLCO,,Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease,"Double-Blind, Placebo-Controlled Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease",TERMINATED,,PHASE2,18.0,ACTUAL,Diffusion Pharmaceuticals Inc,,2.0,,"Due to, among other things, positive results from the 200-302 trial, the trial has been terminated early. Resources shifted to new 200-208 GBM trial using information gained from 200-302.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,,,,,,2022,0.0
NCT03824327,,2019-01-23,,,2023-11-21,2019-01-29,2019-01-31,ACTUAL,,,,,,,2023-11-21,2023-11-24,ACTUAL,2019-02-07,ACTUAL,2019-02-07,2023-11,2023-11-30,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Papaverine and Stereotactic Body Radiotherapy (SBRT) for Non Small Cell Lung Cancer (NSCLC) or Lung Metastases,A Phase I Trial Combining Papaverine and Stereotactic Body Radiation Therapy for Non-Small Cell Lung Cancer or Lung Metastases,SUSPENDED,,PHASE1,24.0,ESTIMATED,Ohio State University Comprehensive Cancer Center,,1.0,,Per an amendment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,OTHER,,,,,,,2024,0.0
NCT04456413,,2020-06-30,2022-12-09,,2023-09-15,2020-06-30,2020-07-02,ACTUAL,2023-01-27,2023-02-10,ACTUAL,,,,2023-09-15,2023-10-10,ACTUAL,2020-11-06,ACTUAL,2020-11-06,2023-09,2023-09-30,2021-05-04,ACTUAL,2021-05-04,2021-04-29,ACTUAL,2021-04-29,,INTERVENTIONAL,,,Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection,Phase II Randomized Study of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Subjects With Early COVID-19 Infection,TERMINATED,,PHASE2,21.0,ACTUAL,Hackensack Meridian Health,"The convalescent plasma technology has been replaced by antivirals and monoclonal antibodies. Therefore, the study was not able to accrue successfully and was subsequently terminated. All available data (due to the lack of a formal analysis) is reported here.",2.0,,Lack of accrual,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,OTHER,,,,,,,2021,0.0
NCT03604549,,2018-07-10,2022-02-03,,2022-04-04,2018-07-20,2018-07-27,ACTUAL,2022-02-03,2022-02-24,ACTUAL,,,,2022-04-04,2022-05-02,ACTUAL,2019-01-11,ACTUAL,2019-01-11,2022-04,2022-04-30,2021-08-25,ACTUAL,2021-08-25,2021-05-31,ACTUAL,2021-05-31,,INTERVENTIONAL,,Baseline analysis population represents subjects having study agent administered during sono HSG procedure,Sonographic Hysterosalpingography: Oil vs Water Based Media (SHOW Trial),Therapeutic Effect of Sonographic Hysterosalpingography: Oil vs Water Based Media,COMPLETED,,PHASE4,58.0,ACTUAL,Milton S. Hershey Medical Center,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,OTHER,,,,,,,2021,1.0
NCT04814433,,2021-03-22,2024-05-31,,2024-05-31,2021-03-22,2021-03-24,ACTUAL,2024-05-31,2024-06-26,ACTUAL,,,,2024-05-31,2024-06-26,ACTUAL,2021-03-24,ACTUAL,2021-03-24,2024-05,2024-05-31,2023-07-10,ACTUAL,2023-07-10,2023-07-10,ACTUAL,2023-07-10,,INTERVENTIONAL,,,Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation,"A Randomized, Single-Blinded, Placebo-Controlled Study Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation",TERMINATED,,PHASE4,46.0,ACTUAL,NYU Langone Health,,4.0,,Both lack of enrollment as well as study staff turnover,f,,,,t,t,f,,,f,,,Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.,"The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to Thomas.Calahan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.",,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)",2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,OTHER,,,,,,,2023,0.0
NCT04142255,,2019-09-08,,,2021-10-27,2019-10-25,2019-10-29,ACTUAL,,,,,,,2021-10-27,2021-11-03,ACTUAL,2019-11-18,ACTUAL,2019-11-18,2021-08,2021-08-31,2020-06-01,ACTUAL,2020-06-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,,,Explore Efficacy of FMT Treating Childhood ASD Patients,A Clinical Study to Explore the Efficacy of Fecal Mircobiota Transplantation (FMT) in the Treatment of Childhood ASD Patients With Gastrointestinal Symptoms,TERMINATED,,EARLY_PHASE1,3.0,ACTUAL,"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",,1.0,,The review board rejected our request of changing the protocol and advised us to terminate the trial.,f,,,,,f,f,,,,,,,,,,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,OTHER,,,,,,,2020,0.0
NCT03316222,,2017-10-10,,,2022-04-25,2017-10-19,2017-10-20,ACTUAL,,,,,,,2022-04-25,2022-05-02,ACTUAL,2018-04-04,ACTUAL,2018-04-04,2022-04,2022-04-30,2022-04-25,ACTUAL,2022-04-25,2021-01-15,ACTUAL,2021-01-15,,INTERVENTIONAL,,,Study of GNS561 in Patients With Liver Cancer,"Phase 1/2a Study to Evaluate the Safety, Activity, and Pharmacokinetics of Escalating Doses of GNS561 in Patients With Primary and Secondary Liver Cancer",TERMINATED,,PHASE1/PHASE2,50.0,ACTUAL,Genoscience Pharma,,2.0,,"only phase 1b was completed and the phase 2 will be an another study, finally",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,INDUSTRY,,,,,,,2022,0.0
NCT03875313,,2019-03-05,2022-01-24,,2022-02-16,2019-03-13,2019-03-14,ACTUAL,2022-02-16,2022-02-17,ACTUAL,,,,2022-02-16,2022-02-17,ACTUAL,2019-05-20,ACTUAL,2019-05-20,2022-02,2022-02-28,2020-07-29,ACTUAL,2020-07-29,2020-07-29,ACTUAL,2020-07-29,,INTERVENTIONAL,,,Study of CB-839 (Telaglenastat) in Combination With Talazoparib in Patients With Solid Tumors,"A Phase 1b/2 Open Label, Dose Escalation and Expansion Study of the Glutaminase Inhibitor CB-839 in Combination With the PARP Inhibitor Talazoparib in Patients With Advanced or Metastatic Solid Tumors",TERMINATED,,PHASE1/PHASE2,33.0,ACTUAL,"Calithera Biosciences, Inc",,5.0,,Slow Enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,,,,,,2020,0.0
NCT02345850,,2015-01-22,2021-10-06,,2023-03-02,2015-01-22,2015-01-26,ESTIMATED,2021-11-22,2021-12-21,ACTUAL,,,,2023-03-02,2023-03-07,ACTUAL,2015-08,ACTUAL,2015-08-31,2023-03,2023-03-31,2020-10-05,ACTUAL,2020-10-05,2020-10-05,ACTUAL,2020-10-05,,INTERVENTIONAL,,Baseline characteristics are summarized for all patients.,Calcineurin Inhibitor-Free Interventions BMT CTN 1301 for Prevention of Graft-versus-Host Disease (BMT CTN 1301),"A Randomized, Multi-Center, Phase III Trial of Calcineurin Inhibitor-Free Interventions for Prevention of Graft-versus-Host Disease (BMT CTN 1301; Progress II)",COMPLETED,,PHASE3,346.0,ACTUAL,"National Heart, Lung, and Blood Institute (NHLBI)",,3.0,,,f,,,,t,,,,,,,,Within 6 months of official study closure at participating sites.,Available to the public,https://biolincc.nhlbi.nih.gov/home/,YES,"Results will be published in a manuscript and supporting information submitted to NIH BioLINCC (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc where indicated).",2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,NIH,,,,,,,2020,1.0
NCT03333109,,2017-11-02,2021-01-11,,2021-10-07,2017-11-02,2017-11-06,ACTUAL,2021-03-06,2021-03-09,ACTUAL,,,,2021-10-07,2021-10-11,ACTUAL,2018-02-08,ACTUAL,2018-02-08,2021-10,2021-10-31,2020-01-13,ACTUAL,2020-01-13,2020-01-13,ACTUAL,2020-01-13,,INTERVENTIONAL,EMPOwER,,Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients,"A 12-week Double-blind, Randomized, Multi-center Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous AMG 334 Against Placebo in Adult Episodic Migraine Patients (EMPOwER)",COMPLETED,,PHASE3,900.0,ACTUAL,Novartis,,3.0,,,f,,,,f,t,f,,,t,,,,,https://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,,,,,,2020,1.0
NCT00701701,,2008-06-17,2020-08-28,,2022-03-24,2008-06-17,2008-06-19,ESTIMATED,2020-09-17,2020-10-12,ACTUAL,,,,2022-03-24,2022-04-07,ACTUAL,2008-12-14,ACTUAL,2008-12-14,2022-03,2022-03-31,2020-02-18,ACTUAL,2020-02-18,2020-02-18,ACTUAL,2020-02-18,,INTERVENTIONAL,,"Baseline population is based on full analysis set which included participants who signed informed consent, completed all baseline assessments, and received at least 1 dose of alglucosidase alfa.",Immune Tolerance Induction Study,An Exploratory Study of the Safety and Efficacy of Immune Tolerance Induction (ITI) in Patients With Pompe Disease Who Have Previously Received Myozyme,TERMINATED,,PHASE4,4.0,ACTUAL,Sanofi,"Due to low number of enrollment and exploratory nature of outcome measure, only safety data were summarized and reported.",2.0,,Study was conducted to fulfill a post marketing commitment (PMC 6). FDA acknowledged fulfillment of PMC.,f,,,,t,,,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,,,,,,2020,0.0
NCT02823574,,2016-07-01,2021-09-27,2020-01-22,2023-04-28,2016-07-01,2016-07-06,ESTIMATED,2022-03-24,2022-04-21,ACTUAL,2020-01-22,2020-01-29,ACTUAL,2023-04-28,2023-05-03,ACTUAL,2016-11-08,ACTUAL,2016-11-08,2023-04,2023-04-30,2022-04-21,ACTUAL,2022-04-21,2019-01-23,ACTUAL,2019-01-23,,INTERVENTIONAL,CheckMate 714,All Randomized Participants,Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck,"A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)",COMPLETED,,PHASE2,425.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,t,,,,t,t,f,,,,,,,,,,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,NCT03126643,APPROVED_FOR_MARKETING,,,,2022,1.0
NCT05980507,,2023-07-31,,,2023-12-17,2023-07-31,2023-08-08,ACTUAL,,,,,,,2023-12-17,2023-12-22,ACTUAL,2023-10-09,ESTIMATED,2023-10-09,2023-07,2023-07-31,2023-10-18,ESTIMATED,2023-10-18,2023-10-18,ESTIMATED,2023-10-18,,INTERVENTIONAL,,,"An Open Label, Single-arm Clinical Study Evaluating the Safety and Efficacy of ICI201 Infusion in Relapsed/Refractory Multiple Myeloma","An Open Label, Single-arm Clinical Study Evaluating the Safety and Efficacy of ICI201 Infusion in Relapsed/Refractory Multiple Myeloma",WITHDRAWN,,PHASE1,0.0,ACTUAL,The First Affiliated Hospital of Soochow University,,1.0,,Molecular development strategy adjustment,f,,,,f,f,f,,,,,,,,,,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,OTHER,,,,,,,2023,0.0
NCT04633148,,2020-11-11,,,2024-04-22,2020-11-11,2020-11-18,ACTUAL,,,,,,,2024-04-22,2024-04-23,ACTUAL,2020-11-23,ACTUAL,2020-11-23,2024-04,2024-04-30,2024-03-28,ACTUAL,2024-03-28,2024-03-28,ACTUAL,2024-03-28,,INTERVENTIONAL,,,Dose-escalating Trial With UniCAR02-T Cells and PSMA Target Module (TMpPSMA) in Patients With Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSMA Marker,"Multicenter, Open-label, Adaptive Design Phase I Trial With Genetically Modified T-cells Carrying Universal Chimeric Antigen Receptors (UniCAR02-T) in Combination With PSMA Peptide Target Module (TMpPSMA) for the Treatment of Patients With Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSMA Marker",TERMINATED,,PHASE1,16.0,ACTUAL,AvenCell Europe GmbH,,1.0,,"Although IMP has been well tolerated, biological activity was very limited. The sponsor concluded that continued development of IMP would be unlikely to result in meaningful clinical benefit for patients with prostate cancer.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,,,,,,2024,0.0
NCT03689946,,2018-09-27,2024-05-03,2024-01-24,2024-06-24,2018-09-27,2018-10-01,ACTUAL,2024-06-24,2024-07-17,ACTUAL,,2024-07-17,ACTUAL,2024-06-24,2024-07-17,ACTUAL,2019-03-19,ACTUAL,2019-03-19,2024-06,2024-06-30,2023-05-30,ACTUAL,2023-05-30,2023-01-28,ACTUAL,2023-01-28,,INTERVENTIONAL,,"Of the 55 patients initially enrolled, 3 were lost to follow-up, 3 withdrew consent, and 2 were not included in analysis due to missing imaging information",Effect of Evolocumab on Coronary Atherosclerosis,Effect of Evolocumab on Coronary Artery Plaque Volume and Composition by Coronary CTA (CCTA) and Microcalcification by F18-NaF PET: A Phase 3 Study,COMPLETED,,PHASE3,55.0,ACTUAL,Cedars-Sinai Medical Center,"1. The sample size is small, and the study population was selectively chosen based on baseline plaque burden.~2. Because inclusion criteria focused on plaque burden, the predominantly male population, known to have higher plaque burden, limits the generalizability of the findings.~3. As a single-arm study, the absence of a comparison group receiving statin only treatment or a control group receiving no treatment limits the ability to draw direct comparisons.",1.0,,,f,,,,f,t,t,,,,,,,,,NO,,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,OTHER,,,,,,,2023,1.0
NCT03578354,,2018-05-31,,,2024-06-28,2018-07-03,2018-07-06,ACTUAL,,,,,,,2024-06-28,2024-07-01,ACTUAL,2019-01,ESTIMATED,2019-01-31,2024-06,2024-06-30,2024-08,ESTIMATED,2024-08-31,2023-01,ESTIMATED,2023-01-31,,INTERVENTIONAL,,,"4-Aminopyridine, Atenolol, or Placebo in Patients With Vestibular Migraine","Prospective, Randomized, Placebo-controlled, Phase 2 Study of 4-aminopyridine, Atenolol, or Placebo in the Treatment of Patients With Vestibular Migraine",WITHDRAWN,,PHASE2,0.0,ACTUAL,Massachusetts Eye and Ear Infirmary,,3.0,,Funding not acquired,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 07:05:33.558621,2024-10-16 07:05:33.558621,OTHER,,,,,,,2024,0.0
NCT00753545,,2008-09-12,2012-12-07,,2024-03-20,2008-09-15,2008-09-16,ESTIMATED,2013-02-06,2013-03-11,ESTIMATED,,,,2024-03-20,2024-03-21,ACTUAL,2008-08-28,ACTUAL,2008-08-28,2024-03,2024-03-31,2023-10-12,ACTUAL,2023-10-12,2010-06-30,ACTUAL,2010-06-30,,INTERVENTIONAL,,,Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer,"Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens",COMPLETED,,PHASE2,265.0,ACTUAL,AstraZeneca,"For OM DoR: The subset of patients evaluable for response who responded to study treatment.Values in results table may be under-estimates as some patients had not progressed at final analysis,so true duration is likely to be greater than in database.",2.0,,,t,,,,f,,,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-15 18:57:34.238896,2024-10-15 18:57:34.238896,INDUSTRY,,NCT03079687,APPROVED_FOR_MARKETING,,,,2023,1.0
NCT04464512,,2020-07-05,,,2022-12-07,2020-07-08,2020-07-09,ACTUAL,,,,,,,2022-12-07,2022-12-12,ACTUAL,2020-01-10,ACTUAL,2020-01-10,2022-12,2022-12-31,2021-08-22,ACTUAL,2021-08-22,2021-08-22,ACTUAL,2021-08-22,,INTERVENTIONAL,SUPER-ERAS,,Suboxone User Perioperative Early Referral and Enhanced Recovery After Surgery- Orthopaedic Trauma Surgery Population,Suboxone User Perioperative Early Referral and Enhanced Recovery After Surgery- Orthopaedic Trauma Surgery Population,WITHDRAWN,,PHASE4,0.0,ACTUAL,West Virginia University,,2.0,,No qualified enrollments; study cancelled due to pandemic,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,OTHER,,,,,,,2021,0.0
NCT04570449,,2020-09-29,,,2020-12-22,2020-09-29,2020-09-30,ACTUAL,,,,,,,2020-12-22,2020-12-24,ACTUAL,2020-11,ESTIMATED,2020-11-30,2020-12,2020-12-31,2021-12,ESTIMATED,2021-12-31,2021-11,ESTIMATED,2021-11-30,,INTERVENTIONAL,,,Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19),Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19),WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Milton S. Hershey Medical Center,,2.0,,Study timeline is not feasible,f,,,,,t,f,,,,,,,,,,,2024-10-16 07:05:33.558621,2024-10-16 07:05:33.558621,OTHER,,,,,,,2021,0.0
NCT02938013,,2016-10-12,2020-09-08,,2022-02-10,2016-10-17,2016-10-19,ESTIMATED,2020-10-21,2020-11-16,ACTUAL,,,,2022-02-10,2022-02-24,ACTUAL,2017-01,ACTUAL,2017-01-31,2020-10,2020-10-31,2020-09-30,ACTUAL,2020-09-30,2019-09-30,ACTUAL,2019-09-30,,INTERVENTIONAL,deLIVER,,deLIVER: Direct Acting Antiviral Effects on the Liver,deLIVER: Direct Acting Antiviral Effects on the Liver,COMPLETED,,PHASE4,15.0,ACTUAL,Johns Hopkins University,This study is based on a relatively small sample of the liver,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,OTHER,,,,,,,2020,1.0
NCT03059563,,2017-02-06,,,2024-05-06,2017-02-16,2017-02-23,ACTUAL,,,,,,,2024-05-06,2024-05-08,ACTUAL,2018-01-11,ACTUAL,2018-01-11,2024-05,2024-05-31,2023-09-28,ACTUAL,2023-09-28,2023-09-28,ACTUAL,2023-09-28,,INTERVENTIONAL,,,Dopamine D2/D3 Receptor Upregulation by Varenicline in Methamphetamine Users,Dopamine D2/D3 Receptor Upregulation by Varenicline in Methamphetamine Users,TERMINATED,,PHASE1,62.0,ACTUAL,"University of California, Los Angeles",,2.0,,Global pandemic,f,,,,,t,f,,,f,,,,,,,,2024-10-16 07:05:33.558621,2024-10-16 07:05:33.558621,OTHER,,,,,,,2023,0.0
NCT04758949,,2021-02-10,,,2021-12-22,2021-02-16,2021-02-17,ACTUAL,,,,,,,2021-12-22,2022-01-11,ACTUAL,2021-08-25,ACTUAL,2021-08-25,2021-12,2021-12-31,2021-12-22,ACTUAL,2021-12-22,2021-12-22,ACTUAL,2021-12-22,,INTERVENTIONAL,,,FL-101 in Surgically Resectable Non-Small Cell Lung Cancer,"A Two-cohort, Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients With Surgically Resectable Non-Small Cell Lung Cancer",WITHDRAWN,,PHASE2,0.0,ACTUAL,Flame Biosciences,,3.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,,,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,INDUSTRY,,,,,,,2021,0.0
NCT04492475,,2020-07-28,2021-10-28,,2022-03-09,2020-07-28,2020-07-30,ACTUAL,2021-11-18,2021-11-22,ACTUAL,,,,2022-03-09,2022-03-14,ACTUAL,2020-08-05,ACTUAL,2020-08-05,2020-11,2020-11-30,2020-12-21,ACTUAL,2020-12-21,2020-12-21,ACTUAL,2020-12-21,,INTERVENTIONAL,,,Adaptive COVID-19 Treatment Trial 3 (ACTT-3),"A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTT-3)",COMPLETED,,PHASE3,969.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,NIH,,,,,,,2020,1.0
NCT02226159,,2014-08-25,2020-09-01,,2024-04-01,2014-08-25,2014-08-27,ESTIMATED,2020-09-25,2020-10-20,ACTUAL,,,,2024-04-01,2024-04-23,ACTUAL,2014-08,ACTUAL,2014-08-31,2024-04,2024-04-30,2024-12-31,ESTIMATED,2024-12-31,2019-05,ACTUAL,2019-05-31,,INTERVENTIONAL,SPIES,,Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain,"Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain (SPIES): a Randomized, Controlled Trial",SUSPENDED,,PHASE4,65.0,ACTUAL,"OrthoCarolina Research Institute, Inc.",,2.0,,insufficient data for data publication,f,,,,t,,,,,,,,,,,,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,OTHER,,,,,,,2024,0.0
NCT03334578,,2017-10-30,,,2023-10-30,2017-11-02,2017-11-07,ACTUAL,,,,,,,2023-10-30,2023-11-01,ACTUAL,2018-08-03,ACTUAL,2018-08-03,2023-10,2023-10-31,2020-12-17,ACTUAL,2020-12-17,2020-12-17,ACTUAL,2020-12-17,,INTERVENTIONAL,,,The Use of Gastrografin to Help Alleviate Bowel Obstruction in Gastroschisis Patients.,The Use of Gastrografin to Help Alleviate Bowel Obstruction Related to Poor Bowel Motility in Gastroschisis Patients.,WITHDRAWN,,PHASE4,0.0,ACTUAL,Lawson Health Research Institute,,2.0,,Lack of recruitment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 07:11:01.772078,2024-10-16 07:11:01.772078,OTHER,,,,,,,2020,0.0
NCT02229149,,2014-08-27,,,2022-11-29,2014-08-28,2014-08-29,ESTIMATED,,,,,,,2022-11-29,2022-12-02,ACTUAL,2014-12,ACTUAL,2014-12-31,2022-11,2022-11-30,2022-01,ACTUAL,2022-01-31,2022-01,ACTUAL,2022-01-31,,INTERVENTIONAL,,,"Phase 2 Study of Standard Chemotherapy With Trastuzumab, Plus or Minus Pertuzumab, for Pre-treated Metastatic Breast Cancer","Randomized Phase II Trial of Chemotherapy of Physician's Choice Plus Trastuzumab Versus Chemotherapy of Physician's Choice Plus Trastuzumab Plus Pertuzumab In Women With Pretreated, HER2-Overexpressing Metastatic Breast Cancer (MBC)",TERMINATED,,PHASE2,33.0,ACTUAL,US Oncology Research,,2.0,,per Sponsor request,f,,,,t,,,,,,,,,,,,,2024-10-16 07:11:01.772078,2024-10-16 07:11:01.772078,INDUSTRY,,,,,,,2022,0.0
NCT03535272,,2018-05-01,,,2024-04-05,2018-05-22,2018-05-24,ACTUAL,,,,,,,2024-04-05,2024-04-09,ACTUAL,2018-05-20,ACTUAL,2018-05-20,2024-04,2024-04-30,2023-12-31,ACTUAL,2023-12-31,2023-11-01,ACTUAL,2023-11-01,,INTERVENTIONAL,,,Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea,Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea and Impact on Acquisition of Gut Antimicrobial Resistance Genes,TERMINATED,,PHASE3,281.0,ACTUAL,Centers for Disease Control and Prevention,,2.0,,Unable to reach target sample size.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,FED,,,,,,,2023,0.0
NCT03936192,,2019-04-29,,,2022-04-11,2019-05-02,2019-05-03,ACTUAL,,,,,,,2022-04-11,2022-04-18,ACTUAL,2019-01,ESTIMATED,2019-01-31,2022-04,2022-04-30,2021-02,ESTIMATED,2021-02-28,2021-02,ESTIMATED,2021-02-28,,INTERVENTIONAL,SAVE,,"A Parallel-group Active Comparator, Double-blind, Multicenter, Randomized, Double-blind, Phase III Clinical Study","Parallel-group Active Comparator, Double-blind, Randomized, Phase III Study to Assess Safety, Efficacy of Glucosamine Sulfate Plus Meloxicam vs Glucosamine Sulfate Plus Chondroitin Sulfate Primary Symptomatic Knee Osteoarthritis Treatment",WITHDRAWN,,PHASE3,0.0,ACTUAL,Eurofarma Laboratorios S.A.,,3.0,,Company decision,f,,,,t,f,f,,,,,,,,,NO,It is not yet known if there will be a plan to make IPD available.,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,INDUSTRY,,,,,,,2021,0.0
NCT03697603,,2018-07-24,2023-08-02,,2024-03-04,2018-10-03,2018-10-05,ACTUAL,2024-03-04,2024-08-09,ACTUAL,,,,2024-03-04,2024-08-09,ACTUAL,2018-07-30,ACTUAL,2018-07-30,2024-03,2024-03-31,2022-07-04,ACTUAL,2022-07-04,2022-06-06,ACTUAL,2022-06-06,,INTERVENTIONAL,,"Full Analysis Set (FAS) which comprised subjects who, after randomization, had received at least 1 dose of the study medication in the double-blind period (Phase B), and from whose the Montgomery Åsberg Depression Rating Scale (MADRS) total scores had been obtained at baseline and at least 1 time point after initiation of the treatment.",A Study of Brexpiprazole in Patients With Major Depressive Disorder,"A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial to Assess the Efficacy and Safety of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive Disorder",COMPLETED,,PHASE2/PHASE3,740.0,ACTUAL,"Otsuka Pharmaceutical Co., Ltd.",,3.0,,,f,,,,f,f,f,,,,,,"Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.",Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.,,YES,Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,INDUSTRY,,,,,,,2022,1.0
NCT03547167,,2018-05-24,2020-12-14,,2020-12-21,2018-05-24,2018-06-06,ACTUAL,2020-12-21,2021-01-15,ACTUAL,,,,2020-12-21,2021-01-15,ACTUAL,2018-07-16,ACTUAL,2018-07-16,2020-12,2020-12-31,2020-01-20,ACTUAL,2020-01-20,2020-01-20,ACTUAL,2020-01-20,,INTERVENTIONAL,,All randomized participants who received at least 1 dose of study vaccination.,"A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)","A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Six Months Later in Immunocompetent Adults Between 18 and 49 Years of Age at Increased Risk for Pneumococcal Disease (PNEU - DAY)",COMPLETED,,PHASE3,1515.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,INDUSTRY,,,,,,,2020,1.0
NCT05494866,,2022-08-08,,,2024-07-10,2022-08-08,2022-08-10,ACTUAL,,,,,,,2024-07-10,2024-07-11,ACTUAL,2022-12-07,ACTUAL,2022-12-07,2024-07,2024-07-31,2024-03-15,ACTUAL,2024-03-15,2024-03-15,ACTUAL,2024-03-15,,INTERVENTIONAL,IntenSify,,A Trial of Cobicistat and Gemcitabine and Nab-Paclitaxel in Patients With Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma,"IntenSify: An Open-label Phase I Trial of the CYP3A Inhibitor Cobicistat and the Cytostatics Gemcitabine and Nab-Paclitaxel in Patients With Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma to Evaluate the Combination's Pharmacokinetics, Safety and Efficacy",TERMINATED,,PHASE1,6.0,ACTUAL,German Cancer Research Center,,1.0,,lack of efficacy paired with high toxicity,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,OTHER,,,,,,,2024,0.0
NCT03129776,,2017-04-17,,,2022-09-20,2017-04-21,2017-04-26,ACTUAL,,,,,,,2022-09-20,2022-09-22,ACTUAL,2017-11-13,ACTUAL,2017-11-13,2022-09,2022-09-30,2022-09-15,ACTUAL,2022-09-15,2022-09-15,ACTUAL,2022-09-15,,INTERVENTIONAL,,,Hyperpolarized 13C MR Imaging of Lactate in Patients With Locally Advanced Cervical Cancer (LACC) Cervical Cancer,Hyperpolarized 13C MR Imaging of Lactate in Patients With Locally Advanced Cervical Cancer for Treatment With Definitive Chemoradiation Therapy,TERMINATED,,PHASE1,4.0,ACTUAL,Sunnybrook Health Sciences Centre,,2.0,,Lack of participants,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,OTHER,,,,,,,2022,0.0
NCT03370510,,2017-12-07,2022-06-14,,2022-08-08,2017-12-07,2017-12-12,ACTUAL,2022-08-08,2022-08-09,ACTUAL,,,,2022-08-08,2022-08-09,ACTUAL,2018-12-07,ACTUAL,2018-12-07,2022-08,2022-08-31,2021-07-28,ACTUAL,2021-07-28,2021-07-28,ACTUAL,2021-07-28,,INTERVENTIONAL,,,Translating Neuroprediction Into Precision Medicine Via Brain Priming,Translating Neuroprediction Into Precision Medicine Via Brain Priming,TERMINATED,,PHASE2,5.0,ACTUAL,Yale University,"This study was terminated early due to issues related to the covid-19 pandemic. Only 3 participants completed the trial- 1 out of 3 in the oxytocin group and 2 in the placebo group. As such, the mean score for the oxytocin group is based off of one subjects data only.",2.0,,Covid-19 Pandemic,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,OTHER,,,,,,,2021,0.0
NCT04855591,,2021-04-20,,,2021-11-18,2021-04-20,2021-04-22,ACTUAL,,,,,,,2021-11-18,2021-12-01,ACTUAL,2021-06-14,ACTUAL,2021-06-14,2021-11,2021-11-30,2021-11-18,ACTUAL,2021-11-18,2021-09-13,ACTUAL,2021-09-13,,INTERVENTIONAL,,,A Trial of SHR-1703 in Healthy Subjects,"A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Evaluate the Safety, Tolerability, PK, PD and Immunogenicity of Single Subcutaneous Administered SHR-1703 in Healthy Caucasian Subjects",TERMINATED,,PHASE1,1.0,ACTUAL,Atridia Pty Ltd.,,4.0,,Adjustment of the clinical development plan for this product globally,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,INDUSTRY,,,,,,,2021,0.0
NCT02927249,,2016-10-05,2023-01-11,,2023-04-03,2016-10-05,2016-10-07,ESTIMATED,2023-03-01,2023-03-27,ACTUAL,,,,2023-04-03,2023-04-05,ACTUAL,2016-12-08,ACTUAL,2016-12-08,2023-04,2023-04-30,2023-02-15,ACTUAL,2023-02-15,2021-12-13,ACTUAL,2021-12-13,,INTERVENTIONAL,,,"Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy",A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial,TERMINATED,,PHASE3,3021.0,ACTUAL,Alliance for Clinical Trials in Oncology,,2.0,,DSMB review,f,,,,t,,,,,,,,,,,,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,OTHER,,,,,,,2023,0.0
NCT02433587,,2015-04-29,,,2019-10-02,2015-04-29,2015-05-05,ESTIMATED,,,,,,,2019-10-02,2019-10-07,ACTUAL,2019-10,ESTIMATED,2019-10-31,2019-10,2019-10-31,2023-07,ESTIMATED,2023-07-31,2021-07,ESTIMATED,2021-07-31,,INTERVENTIONAL,,,Short vs Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization,Evaluation of Short Versus Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization,WITHDRAWN,,PHASE3,0.0,ACTUAL,University Hospitals Cleveland Medical Center,,2.0,,Never recruited any patients.,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,OTHER,,,,,,,2023,0.0
NCT05017454,,2021-08-14,,,2023-06-09,2021-08-20,2021-08-23,ACTUAL,,,,,,,2023-06-09,2023-06-13,ACTUAL,2021-05-01,ACTUAL,2021-05-01,2023-06,2023-06-30,2023-04-01,ACTUAL,2023-04-01,2023-01-01,ACTUAL,2023-01-01,,INTERVENTIONAL,,,Sodium Valproate-loaded Nanospanlastics in Patchy Alopecia Areata in Comparison to Topical Steroids,"Assessment of Efficacy and Safety of Sodium Valproate -Loaded Nanospanlastics in Patients With Patchy Alopecia Areata in Comparison to Conventional Therapy With Topical Steroids: a Randomized Controlled Study, With Clinical, Dermoscopic and Molecular Asessements",COMPLETED,,EARLY_PHASE1,67.0,ACTUAL,Kasr El Aini Hospital,,2.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,OTHER,,,,,,,2023,1.0
NCT04339595,,2020-03-25,,,2021-11-25,2020-04-08,2020-04-09,ACTUAL,,,,,,,2021-11-25,2021-12-08,ACTUAL,2020-01-29,ACTUAL,2020-01-29,2021-11,2021-11-30,2020-07-31,ACTUAL,2020-07-31,2020-07-31,ACTUAL,2020-07-31,,INTERVENTIONAL,MODIFY,,Long-Term Treatment Effect With Tildrakizumab in Participants With Plaque Psoriasis,A Phase IV Interventional Study to Assess the Disease-Modifying Effect of Long-Term Treatment With Tildrakizumab in Adult Patients With Moderate-To-Severe Plaque Psoriasis (MODIFY),TERMINATED,,PHASE4,47.0,ACTUAL,"Almirall, S.A.",,1.0,,Low Recruitment,f,,,,f,f,f,,,,,,,,,,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,INDUSTRY,,,,,,,2020,0.0
NCT04044781,,2019-08-02,,,2021-12-16,2019-08-02,2019-08-05,ACTUAL,,,,,,,2021-12-16,2022-01-10,ACTUAL,2020-01-10,ACTUAL,2020-01-10,2021-12,2021-12-31,2020-05-30,ACTUAL,2020-05-30,2020-04-30,ACTUAL,2020-04-30,,INTERVENTIONAL,,,"A Phase 1, Open-Label, PET Study of T2310 & BPN14770","A Phase 1, Open-Label, Positron Emission Tomography Study in Healthy Subjects to Determine the Relationship Between Plasma Concentration and Brain Target Occupancy of BPN14770",WITHDRAWN,,PHASE1,0.0,ACTUAL,Tetra Discovery Partners,,1.0,,Change in Research Direction,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,INDUSTRY,,,,,,,2020,0.0
NCT03335488,,2017-10-18,2023-06-16,,2024-06-18,2017-11-03,2017-11-07,ACTUAL,2023-06-16,2023-07-10,ACTUAL,,,,2024-06-18,2024-07-01,ACTUAL,2018-02-20,ACTUAL,2018-02-20,2024-06,2024-06-30,2022-12-20,ACTUAL,2022-12-20,2022-07-05,ACTUAL,2022-07-05,,INTERVENTIONAL,,,Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders (UCDs),"A Randomised, Controlled, Open-Label Parallel Arm Study of Safety, PK and Ammonia Control of RAVICTI® (Glycerol Phenylbutyrate) Oral Liquid and Sodium Phenylbutyrate in Phenylbutyrate Treatment Naïve Patients With Urea Cycle Disorders",COMPLETED,,PHASE4,16.0,ACTUAL,Amgen,,2.0,,,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,INDUSTRY,,,,,,,2022,1.0
NCT02417974,,2015-04-01,2022-01-03,,2022-02-26,2015-04-13,2015-04-16,ESTIMATED,2022-02-26,2022-03-24,ACTUAL,,,,2022-02-26,2022-03-24,ACTUAL,2015-09,ACTUAL,2015-09-30,2022-02,2022-02-28,2021-02-04,ACTUAL,2021-02-04,2021-02-04,ACTUAL,2021-02-04,,INTERVENTIONAL,FMT,,Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT),Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT),TERMINATED,,PHASE2,24.0,ACTUAL,Boston Medical Center,Low enrollment was exacerbated by a covid policy related study suspension so the research was stopped.,2.0,,Low enrollment was exacerbated by a covid policy related study suspension so the research was stopped.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,OTHER,,,,,,,2021,0.0
NCT04864782,,2020-12-04,,,2024-01-10,2021-04-25,2021-04-29,ACTUAL,,,,,,,2024-01-10,2024-01-12,ACTUAL,2020-09-23,ACTUAL,2020-09-23,2024-01,2024-01-31,2023-11-01,ACTUAL,2023-11-01,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,,,"QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer","A Study of QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer",TERMINATED,,PHASE2/PHASE3,46.0,ACTUAL,"Qilu Pharmaceutical Co., Ltd.",,1.0,,"Phase 2 completed, phase 3 sponsor decided to terminate",f,,,,,f,f,,,,,,,,,,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,INDUSTRY,,,,,,,2023,0.0
NCT03522259,,2018-04-30,,,2024-02-12,2018-04-30,2018-05-11,ACTUAL,,,,,,,2024-02-12,2024-02-13,ACTUAL,2018-07-19,ACTUAL,2018-07-19,2024-02,2024-02-29,2023-12-31,ACTUAL,2023-12-31,2023-12-31,ACTUAL,2023-12-31,,INTERVENTIONAL,BARIVA,,Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery,BARIVA:Short Versus Extended Prophylaxis of Rivaroxaban for Venous Thromboembolism After Bariatric Surgery,COMPLETED,,PHASE2,272.0,ACTUAL,"Insel Gruppe AG, University Hospital Bern",,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,OTHER,,,,,,,2023,1.0
NCT04226456,,2019-12-09,,,2023-10-23,2020-01-10,2020-01-13,ACTUAL,,,,,,,2023-10-23,2023-10-24,ACTUAL,2021-07-10,ACTUAL,2021-07-10,2023-02,2023-02-28,2023-09-03,ACTUAL,2023-09-03,2023-05-03,ACTUAL,2023-05-03,,INTERVENTIONAL,,,Intratympanic Administration of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity,Clinical Trial: Intratympanic Injection of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity,TERMINATED,,PHASE4,19.0,ACTUAL,Centre Hospitalier Universitaire Saint Pierre,,2.0,,poor recruitment,f,,,,,f,f,,,f,,,,,,,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,OTHER,,,,,,,2023,0.0
NCT03998592,,2019-06-24,,,2021-02-02,2019-06-24,2019-06-26,ACTUAL,,,,,,,2021-02-02,2021-02-04,ACTUAL,2021-05,ESTIMATED,2021-05-31,2021-02,2021-02-28,2023-10,ESTIMATED,2023-10-31,2022-03,ESTIMATED,2022-03-31,,INTERVENTIONAL,,,Clinical Trial to Assess Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes,Phase I Clinical Trial for Assessment of Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes in Healthy Volunteers,WITHDRAWN,,PHASE1,0.0,ACTUAL,Butantan Institute,,4.0,,Agreement between interested partied ended,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,OTHER_GOV,,,,,,,2023,0.0
NCT03207256,,2017-06-28,,,2022-07-20,2017-06-29,2017-07-02,ACTUAL,,,,,,,2022-07-20,2022-07-21,ACTUAL,2017-08-09,ACTUAL,2017-08-09,2022-07,2022-07-31,2022-06-24,ACTUAL,2022-06-24,2022-05-25,ACTUAL,2022-05-25,,INTERVENTIONAL,,,Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials,An Open Label Extension Trial of Ublituximab and/or Umbralisib (TGR-1202) in Combination With Other Novel Agents or as Single Agents in Subjects Currently Receiving Treatment on a TG Therapeutics Study.,TERMINATED,,PHASE2,51.0,ACTUAL,"TG Therapeutics, Inc.",,2.0,,Strategic/Business Decision,f,,,,f,t,f,,,,,,,,,,,2024-10-16 07:11:01.772078,2024-10-16 07:11:01.772078,INDUSTRY,,,,,,,2022,0.0
NCT03803761,,2019-01-14,,,2023-09-22,2019-01-14,2019-01-15,ACTUAL,,,,,,,2023-09-22,2023-09-25,ACTUAL,2019-02-13,ESTIMATED,2019-02-13,2023-09,2023-09-30,2022-02-19,ESTIMATED,2022-02-19,2022-02-19,ESTIMATED,2022-02-19,,INTERVENTIONAL,,,"A Study of a New Drug Combination, Copanlisib and Fulvestrant, in Advanced Breast Cancer",A Phase 2 Study of Copanlisib (BAY 80-6946) in Combination With Fulvestrant in Patients With Metastatic Breast Cancer Progressing After Aromatase Inhibitor Plus CDK 4/6 Inhibitor,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,National Cancer Institute (NCI),,1.0,,Inadequate accrual rate,f,,,,t,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page",2024-10-16 07:11:01.772078,2024-10-16 07:11:01.772078,NIH,,,,,,,2022,0.0
NCT03170882,,2017-05-22,2021-07-30,,2022-11-21,2017-05-26,2017-05-31,ACTUAL,2021-10-25,2021-10-27,ACTUAL,,,,2022-11-21,2022-12-20,ACTUAL,2017-08-01,ACTUAL,2017-08-01,2022-11,2022-11-30,2021-11-26,ACTUAL,2021-11-26,2020-08-01,ACTUAL,2020-08-01,,INTERVENTIONAL,,Intent-to-Treat (ITT) Population included all participants who were randomized.,"A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma","A Phase 2, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma",COMPLETED,,PHASE2,122.0,ACTUAL,Takeda,,2.0,,,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,INDUSTRY,,,,,,,2021,1.0
NCT01939691,,2013-09-06,,,2021-01-11,2013-09-06,2013-09-11,ESTIMATED,,,,,,,2021-01-11,2021-01-13,ACTUAL,2018-09-12,ACTUAL,2018-09-12,2021-01,2021-01-31,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,MEND,,Macular Edema Nepafenac vs. Difluprednate Uveitis Trial,Macular Edema Nepafenac vs. Difluprednate Uveitis Trial,TERMINATED,,PHASE4,9.0,ACTUAL,"University of California, San Francisco",,3.0,,Difficulty enrolling,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,OTHER,,,,,,,2020,0.0
NCT03754660,,2018-11-23,,,2023-09-26,2018-11-23,2018-11-27,ACTUAL,,,,,,,2023-09-26,2023-09-28,ACTUAL,2019-01-21,ACTUAL,2019-01-21,2023-09,2023-09-30,2022-11-03,ACTUAL,2022-11-03,2022-04-24,ACTUAL,2022-04-24,,INTERVENTIONAL,ATMOS,,"This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH)","A Non-randomized Two Part Multi-center, Open-label, Single Dose Trial With an Escalation Part in Untreated Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients (Part A), Followed by a Parallel-group Part in Untreated and Pre-treated Patients With PAH and CTEPH (Part B) to Investigate the Safety, Tolerability and Pharmacodynamics of Inhaled BAY1237592",COMPLETED,,PHASE1,38.0,ACTUAL,Bayer,,3.0,,,f,,,,f,f,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,INDUSTRY,,,,,,,2022,0.0
NCT01256359,,2010-11-17,2021-03-01,,2024-08-14,2010-12-06,2010-12-08,ESTIMATED,2024-08-14,2024-08-15,ACTUAL,,,,2024-08-14,2024-08-15,ACTUAL,2010-10,,2010-10-31,2024-08,2024-08-31,2020-02,ACTUAL,2020-02-29,2012-10,ACTUAL,2012-10-31,,INTERVENTIONAL,DOC-MEK,All randomised patients,Docetaxel With or Without AZD6244 in Melanoma,A Double Blind Randomised Phase 2 Trial of Docetaxel With or Without AZD6244 in wt BRAF Advanced Melanoma,COMPLETED,,PHASE2,83.0,ACTUAL,University of Oxford,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,OTHER,,,,,,,2020,1.0
NCT04359823,,2020-04-21,2022-02-18,,2023-02-27,2020-04-21,2020-04-24,ACTUAL,2023-02-27,2023-12-07,ACTUAL,,,,2023-02-27,2023-12-07,ACTUAL,2020-08-24,ACTUAL,2020-08-24,2023-02,2023-02-28,2021-04-23,ACTUAL,2021-04-23,2021-04-23,ACTUAL,2021-04-23,,INTERVENTIONAL,DSAP,,DSAP Treatment Comparison: 2% Lovastatin/ 2% Cholesterol vs 2% Lovastatin Alone,Topical Treatment for Superficial Disseminated Actinic Porokeratosis: A Single-Blinded Comparison Between Lovastatin/Cholesterol and Lovastatin,COMPLETED,,PHASE1,31.0,ACTUAL,Medical University of South Carolina,Study was limited by covid pandemic requiring virtual appointments with participants. This prevented study team from acquiring in person dermoscopy data and overall limited physical exam assessments.,2.0,,,f,,,,,t,f,,,t,,,,,,NO,,2024-10-16 07:11:01.772078,2024-10-16 07:11:01.772078,OTHER,,,,,,,2021,1.0
NCT03115801,,2016-11-30,2021-07-14,,2021-08-26,2017-04-10,2017-04-14,ACTUAL,2021-08-26,2021-09-22,ACTUAL,,,,2021-08-26,2021-09-22,ACTUAL,2016-11,,2016-11-30,2021-08,2021-08-31,2020-10-13,ACTUAL,2020-10-13,2020-10-13,ACTUAL,2020-10-13,,INTERVENTIONAL,,,A Phase II Randomized Trial of Immunotherapy Plus Radiotherapy in Metastatic Genitourinary Cancers,A Phase II Randomized Controlled Trial of Programmed Death -1/Programmed Death Ligand-1(PD-1/PDL-1) Axis Blockade Versus PD-1/PDL-1 Axis Blockade Plus Radiotherapy in Metastatic Genitourinary (Renal/Urothelial) Malignancies,TERMINATED,,PHASE2,6.0,ACTUAL,Weill Medical College of Cornell University,The clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.,2.0,,Lack of accrual,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 07:11:01.772078,2024-10-16 07:11:01.772078,OTHER,,,,,,,2020,0.0
NCT04113616,,2019-10-01,,,2024-03-21,2019-10-01,2019-10-03,ACTUAL,,,,,,,2024-03-21,2024-03-22,ACTUAL,2019-09-25,ACTUAL,2019-09-25,2024-03,2024-03-31,2023-09-27,ACTUAL,2023-09-27,2023-09-27,ACTUAL,2023-09-27,,INTERVENTIONAL,,,"An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)","An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)",TERMINATED,,PHASE1/PHASE2,70.0,ACTUAL,"Kartos Therapeutics, Inc.",,6.0,,"In September 2023, the study was terminated because of a Sponsor decision, unrelated to safety concerns.",f,,,,,t,f,,,,,,,,,,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,INDUSTRY,,,,,,,2023,0.0
NCT04864977,,2021-04-27,,,2021-08-18,2021-04-27,2021-04-29,ACTUAL,,,,,,,2021-08-18,2021-08-24,ACTUAL,2021-08-16,ESTIMATED,2021-08-16,2021-08,2021-08-31,2022-06-06,ESTIMATED,2022-06-06,2022-06-06,ESTIMATED,2022-06-06,,INTERVENTIONAL,,,A Study of A Novel Approach to Titrate Basal Insulin (LY2963016) in Participants With Type 2 Diabetes,Novel Approach for Basal Insulin Titration: A Proof-of-Concept Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,Eli Lilly and Company,,1.0,,Study was stopped prior to study start date due to business decision.,f,,,,f,t,f,,,t,,,"data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 07:11:01.772078,2024-10-16 07:11:01.772078,INDUSTRY,,,,,,,2022,0.0
NCT03376659,,2017-11-20,2022-10-14,,2024-02-01,2017-12-13,2017-12-18,ACTUAL,2022-12-14,2023-01-10,ACTUAL,,,,2024-02-01,2024-02-05,ACTUAL,2018-08-08,ACTUAL,2018-08-08,2024-02,2024-02-29,2023-08-01,ACTUAL,2023-08-01,2021-08-30,ACTUAL,2021-08-30,,INTERVENTIONAL,,,Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma,"A Phase I/II Trial of the PD-L1 Inhibitor, Durvalumab Plus CV301 in Combination With Maintenance Chemotherapy for Patients With Metastatic Colorectal or Pancreatic Adenocarcinoma",TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,Georgetown University,,3.0,,Study closed due to lack of enrollment.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,OTHER,,,,,,,2023,0.0
NCT04990388,,2021-07-26,2024-03-18,,2024-04-15,2021-07-26,2021-08-04,ACTUAL,2024-04-15,2024-04-16,ACTUAL,,,,2024-04-15,2024-04-16,ACTUAL,2021-10-18,ACTUAL,2021-10-18,2024-04,2024-04-30,2023-03-20,ACTUAL,2023-03-20,2023-03-20,ACTUAL,2023-03-20,,INTERVENTIONAL,,,"Safety, Tolerability, and Pharmacokinetics of UX053 in Patients With Glycogen Storage Disease Type III (GSD III)","A Phase 1/2 First-in-human, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses and Repeat Doses of UX053 in Patients With GSD III",TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,Ultragenyx Pharmaceutical Inc,,6.0,,Sponsor decision not related to safety concerns,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,INDUSTRY,,,,,,,2023,0.0
NCT02282020,,2014-10-20,2019-10-03,,2022-07-25,2014-10-31,2014-11-04,ESTIMATED,2019-11-27,2019-12-02,ACTUAL,,,,2022-07-25,2022-07-26,ACTUAL,2015-02-06,ACTUAL,2015-02-06,2022-07,2022-07-31,2022-07-19,ACTUAL,2022-07-19,2018-10-10,ACTUAL,2018-10-10,,INTERVENTIONAL,SOLO3,Baseline characteristics are displayed for all participants who started the study. This includes the 12 participants who did not receive treatment in the 'Single Agent Chemotherapy' arm.,Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments,"A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physician's Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients Carrying Germline BRCA1/2 Mutations.",COMPLETED,,PHASE3,266.0,ACTUAL,AstraZeneca,,2.0,,,t,,,,t,,,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,INDUSTRY,,NCT03079687,APPROVED_FOR_MARKETING,,,,2022,1.0
NCT03958955,,2019-05-20,2021-04-14,,2021-06-04,2019-05-20,2019-05-22,ACTUAL,2021-06-04,2021-06-28,ACTUAL,,,,2021-06-04,2021-06-28,ACTUAL,2019-07-09,ACTUAL,2019-07-09,2020-05,2020-05-31,2020-04-30,ACTUAL,2020-04-30,2020-04-15,ACTUAL,2020-04-15,,INTERVENTIONAL,,Randomised subjects,Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.,Efficacy and Safety of Twice-daily Application of Delgocitinib Cream 20 mg/g for 6 Weeks in Subjects With Active Discoid Lupus Erythematosus.,TERMINATED,,PHASE2,27.0,ACTUAL,LEO Pharma,"The trial was terminated prematurely due to slow recruitment, and due to an anticipation that recruitment would become further delayed due to the COVID-19 pandemic affecting recruitment activities. The total number of subjects included in the trial therefore ended with 27 subjects randomised. 26 subjects completed the trial, as 1 subject withdrew from the trial due to an AE (moderate cutaneous lupus erythematosus \[CLE\]; reported term: cutaneous lupus erythematosus flare).",2.0,,Terminated due to recruitment challenges.,f,,,,f,t,f,,,,,,Data is available to request after approval of the studied indication.,,https://www.leopharmatrials.com/en/for-professionals,YES,De-identified individual patient data (IPD) can be made available to researchers in a closed environment for a specified period of time.~Data sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.,2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,INDUSTRY,,,,,,,2020,0.0
NCT04933942,,2021-06-14,,,2023-05-23,2021-06-14,2021-06-22,ACTUAL,,,,,,,2023-05-23,2023-05-24,ACTUAL,2022-09-13,ACTUAL,2022-09-13,2023-05,2023-05-31,2022-12-19,ACTUAL,2022-12-19,2022-12-19,ACTUAL,2022-12-19,,INTERVENTIONAL,RIGOLETTO,,Phase II Trial of Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-meth Glioblastoma,Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-methylated Glioblastoma: a Randomized Phase II Open Label Multicenter Study,WITHDRAWN,,PHASE2,0.0,ACTUAL,European Organisation for Research and Treatment of Cancer - EORTC,,2.0,,Amgen withdrew interest in providing further financial support,f,,,,t,f,f,,,,,,,,,,,2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,NETWORK,,,,,,,2022,0.0
NCT05104892,,2021-10-17,,,2024-03-06,2021-11-02,2021-11-03,ACTUAL,,,,,,,2024-03-06,2024-03-07,ACTUAL,2021-12-12,ACTUAL,2021-12-12,2024-03,2024-03-31,2024-02-28,ACTUAL,2024-02-28,2024-02-06,ACTUAL,2024-02-06,,INTERVENTIONAL,,,Proof of Concept Study of Rilzabrutinib in Adult Participants With Moderate-to-severe Asthma,"A Randomized, Double-blind, Placebo-controlled, Parallel-group, 12 Week Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety, and Tolerability of Rilzabrutinib in Participants With Moderate-to-severe Asthma Who Are Not Well Controlled on Inhaled Corticosteroid (ICS) Plus Long-acting β2 Adrenergic Agonist (LABA) Therapy",COMPLETED,,PHASE2,196.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,f,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,INDUSTRY,,,,,,,2024,1.0
NCT03883828,,2019-02-18,2023-05-02,,2023-11-08,2019-03-18,2019-03-21,ACTUAL,2023-11-08,2023-11-13,ACTUAL,,,,2023-11-08,2023-11-13,ACTUAL,2019-06-03,ACTUAL,2019-06-03,2023-11,2023-11-30,2021-12-02,ACTUAL,2021-12-02,2021-12-02,ACTUAL,2021-12-02,,INTERVENTIONAL,,Baseline information and data was only collected for 77 participants (39 in the treatment arm and 38 in the control arm),Bacterial Decolonization to Prevent Radiation Dermatitis,Bacterial Decolonization to Prevent Radiation Dermatitis: A Randomized Controlled Trial and Quality of Life Assessment,COMPLETED,,PHASE2/PHASE3,80.0,ACTUAL,Montefiore Medical Center,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,OTHER,,,,,,,2021,1.0
NCT05162131,,2021-12-02,,,2024-01-19,2021-12-16,2021-12-17,ACTUAL,,,,,,,2024-01-19,2024-01-22,ACTUAL,2021-12-25,ACTUAL,2021-12-25,2024-01,2024-01-31,2022-12-30,ACTUAL,2022-12-30,2022-12-30,ACTUAL,2022-12-30,,INTERVENTIONAL,,,"Study to Evaluate the Safety, Tolerability, PK, and PD of PB2452 With and Without Ticagrelor Pretreatment in Chinese Healthy Volunteers","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PB2452 (Bentracimab) With and Without Ticagrelor Pretreatment in Chinese Healthy Volunteers",TERMINATED,,PHASE1,34.0,ACTUAL,"SFJ Pharmaceuticals, Inc.",,7.0,,"After recruitment of Cohorts 1-4 was completed, Sponsor decided to terminate study, initially due to COVID and then considering that PK data from the dose planned to be tested in Cohort 5 (18000 mg) would be available from the ongoing Phase 3 study.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,INDUSTRY,,,,,,,2022,0.0
NCT03679481,,2018-07-24,,,2019-10-14,2018-09-19,2018-09-20,ACTUAL,,,,,,,2019-10-14,2019-10-17,ACTUAL,2020-04-01,ESTIMATED,2020-04-01,2019-10,2019-10-31,2021-04-01,ESTIMATED,2021-04-01,2021-04-01,ESTIMATED,2021-04-01,,INTERVENTIONAL,,,The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery,The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery,WITHDRAWN,,PHASE4,0.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,study not started due to lack of funding,f,,,,,t,f,,,f,,,,,,,,2024-10-16 07:11:01.772078,2024-10-16 07:11:01.772078,OTHER,,,,,,,2021,0.0
NCT04718467,,2021-01-20,,,2021-05-21,2021-01-20,2021-01-22,ACTUAL,,,,,,,2021-05-21,2021-05-25,ACTUAL,2021-02-01,ESTIMATED,2021-02-01,2021-05,2021-05-31,2022-03-15,ESTIMATED,2022-03-15,2021-05-15,ESTIMATED,2021-05-15,,INTERVENTIONAL,,,Phase IIb Clinical Trial of Recombinant Novel Coronavirus Pneumonia (COVID-19) Vaccine (Sf9 Cells),"A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱb Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 to 85 Years Old",WITHDRAWN,,PHASE2,0.0,ACTUAL,Jiangsu Province Centers for Disease Control and Prevention,,4.0,,Sponsor decided to cancel this trial.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 10:06:43.168369,2024-10-15 10:06:43.168369,NETWORK,,,,,,,2022,0.0
NCT03739866,,2018-11-02,2020-11-12,,2021-03-16,2018-11-09,2018-11-14,ACTUAL,2020-11-12,2020-12-09,ACTUAL,,,,2021-03-16,2021-04-09,ACTUAL,2018-11-26,ACTUAL,2018-11-26,2021-03,2021-03-31,2020-06-15,ACTUAL,2020-06-15,2019-11-14,ACTUAL,2019-11-14,,INTERVENTIONAL,,Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.,"Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults","A Phase 1b Randomized, Double-Blinded, Placebo Controlled, Multi-Cohort Study of the Safety, Pharmacokinetics, and Antiviral Activity of GS-6207 Administered Subcutaneously in HIV-1 Infected Subjects",COMPLETED,,PHASE1,53.0,ACTUAL,Gilead Sciences,,8.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 19:03:29.435509,2024-10-15 19:03:29.435509,INDUSTRY,,,,,,,2020,1.0
NCT02795884,,2016-02-24,,,2016-12-29,2016-06-09,2016-06-10,ESTIMATED,,,,,,,2016-12-29,2016-12-30,ESTIMATED,2016-06,,2016-06-30,2016-12,2016-12-31,2020-11,ESTIMATED,2020-11-30,2020-11,ESTIMATED,2020-11-30,,INTERVENTIONAL,,,Adjuvant Erlotinib Intercalating Chemotherapy or Adjuvant Chemotherapy Alone in NSCLC With Common EGFR Mutation,,WITHDRAWN,,PHASE3,0.0,ACTUAL,Yonsei University,,2.0,,Because of reconsideration of using erlotinib(EGFR Tyrosine kinase inhibitor) as adjuvant aim,f,,,,f,,,,,,,,,,,NO,no plan to share data,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,OTHER,,,,,,,2020,0.0
NCT03206970,,2017-06-29,2020-03-31,,2021-10-08,2017-06-29,2017-07-02,ACTUAL,2020-05-01,2020-05-13,ACTUAL,,,,2021-10-08,2021-11-05,ACTUAL,2017-03-02,ACTUAL,2017-03-02,2021-10,2021-10-31,2020-09-08,ACTUAL,2020-09-08,2019-02-15,ACTUAL,2019-02-15,,INTERVENTIONAL,,Safety Analysis Set: All participants who received any dose of study drug.,Study to Evaluate Efficacy and Safety of BGB-3111 in Participants With Relapsed or Refractory Mantle Cell Lymphoma (MCL),"A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)",COMPLETED,,PHASE2,86.0,ACTUAL,BeiGene,,1.0,,,f,,,,t,f,f,,,,,,,,,YES,,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,INDUSTRY,,,,,,,2020,1.0
NCT03732807,,2018-11-05,2021-12-16,,2022-02-01,2018-11-05,2018-11-07,ACTUAL,2022-02-01,2022-02-24,ACTUAL,,,,2022-02-01,2022-02-24,ACTUAL,2018-12-03,ACTUAL,2018-12-03,2022-02,2022-02-28,2021-06-24,ACTUAL,2021-06-24,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,ALLEGRO-2b/3,"Full analysis set (FAS) included all participants who were randomized, regardless of whether they received study medication.",PF-06651600 for the Treatment of Alopecia Areata,"A PHASE 2B/3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR GREATER SCALP HAIR LOSS",COMPLETED,,PHASE2/PHASE3,718.0,ACTUAL,Pfizer,,7.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,INDUSTRY,,,,,,,2021,1.0
NCT03680976,,2016-03-09,,,2018-09-20,2018-09-20,2018-09-21,ACTUAL,,,,,,,2018-09-20,2018-09-21,ACTUAL,,,,2018-09,2018-09-30,2021-04,ESTIMATED,2021-04-30,2021-04,ESTIMATED,2021-04-30,,INTERVENTIONAL,ALMA,,Anti-Inflammatory Lipid Mediators in Asthma,Anti-Inflammatory Lipid Mediators in Asthma,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Pittsburgh,,2.0,,The study will not take place at the University of Pittsburgh,f,,,,t,t,f,,,,,,,,,,,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,OTHER,,,,,,,2021,0.0
NCT04064684,,2019-08-16,2022-05-04,2022-01-11,2022-06-24,2019-08-19,2019-08-22,ACTUAL,2022-05-04,2022-05-31,ACTUAL,2022-01-21,2022-01-26,ACTUAL,2022-06-24,2022-07-13,ACTUAL,2020-02-04,ACTUAL,2020-02-04,2022-06,2022-06-30,2020-03-30,ACTUAL,2020-03-30,2020-03-30,ACTUAL,2020-03-30,,INTERVENTIONAL,,,Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome,"Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome (PARDS), a Randomized Pilot Trial",TERMINATED,,PHASE2,2.0,ACTUAL,"The University of Texas Health Science Center, Houston",Enrollment difficulties after start of the COVID-19 pandemic leading to small sample size,2.0,,Enrollment difficulties after the start of the COVID-19 pandemic.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 07:11:01.772078,2024-10-16 07:11:01.772078,OTHER,,,,,,,2020,0.0
NCT05144984,,2021-11-22,,2024-02-12,2024-02-12,2021-11-22,2021-12-06,ACTUAL,,,,,2024-02-13,ACTUAL,2024-02-12,2024-02-13,ACTUAL,2021-11-29,ACTUAL,2021-11-29,2024-02,2024-02-29,2023-03-23,ACTUAL,2023-03-23,2023-02-13,ACTUAL,2023-02-13,,INTERVENTIONAL,,,A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes,Investigation of the Safety and Efficacy of Semaglutide s.c. in Combination With NNC0480-0389 in Participants With Type 2 Diabetes - a Dose Finding Study,COMPLETED,,PHASE2,500.0,ACTUAL,Novo Nordisk A/S,,10.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,INDUSTRY,,,,,,,2023,1.0
NCT04422392,,2020-06-04,,,2023-08-27,2020-06-05,2020-06-09,ACTUAL,,,,,,,2023-08-27,2023-08-30,ACTUAL,2020-07-13,ACTUAL,2020-07-13,2023-08,2023-08-31,2022-09-30,ACTUAL,2022-09-30,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,,,Neoadjuvant PD-1 Antibody Plus Chemotherapy in Resectable Stage IIIA-N2 Non-Small-Cell Lung Cancer,Neoadjuvant PD-1 Antibody Plus Chemotherapy in Resectable Stage IIIA-N2 Non-Small-Cell Lung Cancer: A Randomized Phase II Study,TERMINATED,,PHASE2,93.0,ACTUAL,"Shanghai Pulmonary Hospital, Shanghai, China",,2.0,,"since the CheckMate816 study is published in NEJM, enrolling patients becomes difficult",f,,,,,f,f,,,,,,,,,,,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,OTHER,,,,,,,2022,0.0
NCT04256148,,2020-01-27,,,2020-07-09,2020-02-03,2020-02-05,ACTUAL,,,,,,,2020-07-09,2020-07-13,ACTUAL,2021-07,ESTIMATED,2021-07-31,2020-07,2020-07-31,2023-04-30,ESTIMATED,2023-04-30,2022-10-30,ESTIMATED,2022-10-30,,INTERVENTIONAL,,,ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,4.0,,Study is withdrawn due to the global impact of the COVID-19 pandemic.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,INDUSTRY,,,,,,,2023,0.0
NCT04730206,,2021-01-28,,,2022-09-29,2021-01-28,2021-01-29,ACTUAL,,,,,,,2022-09-29,2022-10-03,ACTUAL,2021-06-15,ACTUAL,2021-06-15,2022-09,2022-09-30,2022-07-13,ACTUAL,2022-07-13,2022-07-13,ACTUAL,2022-07-13,,INTERVENTIONAL,DAWN,,The DAWN Antivirals Trial for Ambulatory COVID-19 Patients,The DAWN Antivirals Trial: the Efficacy of Antivirals for COVID-19 Infections Presenting to Ambulatory Care: a Randomized Controlled Trial,TERMINATED,,PHASE3,44.0,ACTUAL,KU Leuven,,3.0,,recruitment was too slow,f,,,,t,f,f,,,,,,,,,,,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,OTHER,,,,,,,2022,0.0
NCT04788459,,2021-03-01,,,2023-03-28,2021-03-05,2021-03-09,ACTUAL,,,,,,,2023-03-28,2023-03-29,ACTUAL,2021-02-25,ACTUAL,2021-02-25,2021-12,2021-12-31,2021-12-07,ACTUAL,2021-12-07,2021-12-07,ACTUAL,2021-12-07,,INTERVENTIONAL,,,"Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers","A Phase I/II Study to Assess the Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers",TERMINATED,,PHASE1/PHASE2,68.0,ACTUAL,Takis,,4.0,,The good progress of the Italian national vaccination campaign against COVID-19 made impossible to complete the study as planned.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,INDUSTRY,,,,,,,2021,0.0
NCT04640194,,2020-11-20,2023-07-24,,2024-03-11,2020-11-20,2020-11-23,ACTUAL,2023-07-24,2024-03-07,ACTUAL,,,,2024-03-11,2024-03-20,ACTUAL,2020-12-16,ACTUAL,2020-12-16,2024-03,2024-03-31,2022-07-25,ACTUAL,2022-07-25,2022-07-19,ACTUAL,2022-07-19,,INTERVENTIONAL,TRISTARDS,The Full Analysis Set (FAS) consisted of all randomised patients with at least one baseline and one post baseline assessment relating to the primary endpoint of interest.,A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19,"The TRISTARDS Trial - ThRombolysIS Therapy for ARDS A Phase IIb/III Operationally Seamless, Open-label, Randomised, Sequential, Parallel-group Adaptive Study to Evaluate the Efficacy and Safety of Daily Intravenous Alteplase Treatment Given up to 5 Days on Top of Standard of Care (SOC) Compared With SOC Alone, in Patients With Acute Respiratory Distress Syndrome (ARDS) Triggered by COVID-19",COMPLETED,,PHASE2/PHASE3,104.0,ACTUAL,Boehringer Ingelheim,"Results for the invasive mechanical ventilation (IMV) patients were only analyzed descriptively due to insufficient enrolled patients. For the All-Cause Mortality endpoint, the non-invasive mechanical ventilation (NIV) arm did not have enough events to perform the adjusted statistical model, instead the unadjusted model is presented for this endpoint.",7.0,,,f,,,,t,f,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,INDUSTRY,,,,,,,2022,0.0
NCT03589768,,2018-06-14,2022-11-17,2021-06-21,2022-12-22,2018-07-05,2018-07-18,ACTUAL,2022-12-22,2023-01-20,ACTUAL,2022-12-22,2023-01-20,ACTUAL,2022-12-22,2023-01-20,ACTUAL,2019-01-24,ACTUAL,2019-01-24,2018-10-04,2018-10-04,2020-07-01,ACTUAL,2020-07-01,2020-07-01,ACTUAL,2020-07-01,,INTERVENTIONAL,,Population includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.,Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants,"A Phase II Double-Blind Trial to Evaluate the Safety, Immunogenicity and Effect on Infant Immune Responses of a Single Dose of Tdap in Pregnant Women in Mali",COMPLETED,,PHASE2,399.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,NIH,,,,,,,2020,1.0
NCT04863339,,2021-04-23,,,2022-03-25,2021-04-23,2021-04-28,ACTUAL,,,,,,,2022-03-25,2022-04-05,ACTUAL,2022-03,ESTIMATED,2022-03-31,2022-03,2022-03-31,2022-04,ESTIMATED,2022-04-30,2022-04,ESTIMATED,2022-04-30,,INTERVENTIONAL,,,Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery,Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery: A Double-Blind Randomized Controlled Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,Challenges in recruitment,f,,,,,t,f,,,t,,,12 to 24 months following publication,Requests for IPD can be made by email and will be reviewed by the PI. The study protocol and deidentified data can be provided for scientific analyses performed by physicians and researchers affiliated with academic institutions.,,YES,"Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.",2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,OTHER,,,,,,,2022,0.0
NCT02788019,,2016-05-20,2021-02-25,,2021-03-24,2016-05-26,2016-06-02,ESTIMATED,2021-03-24,2021-04-21,ACTUAL,,,,2021-03-24,2021-04-21,ACTUAL,2016-05-26,ACTUAL,2016-05-26,2021-03,2021-03-31,2020-03-23,ACTUAL,2020-03-23,2020-03-23,ACTUAL,2020-03-23,,INTERVENTIONAL,,The study was terminated for failure of enrollment prior to reaching 34 participants in each group.,Adductor Canal Mid-thigh and Adductor Canal Distal Thigh: Is Cutaneous Sensory Blockade Similar Among Block Techniques?,Adductor Canal Mid-thigh and Adductor Canal Distal Thigh: Is Cutaneous Sensory Blockade Similar Among Block Techniques?,TERMINATED,,PHASE4,52.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,Unable to complete the sample size needed for 80% power due to changes in surgical approach to adductor block usage.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,OTHER,,,,,,,2020,0.0
NCT02554812,,2015-09-16,2024-03-20,,2024-07-05,2015-09-17,2015-09-18,ESTIMATED,2024-07-05,2024-07-30,ACTUAL,,,,2024-07-05,2024-07-30,ACTUAL,2015-11-09,ACTUAL,2015-11-09,2024-07,2024-07-31,2023-03-23,ACTUAL,2023-03-23,2023-03-23,ACTUAL,2023-03-23,,INTERVENTIONAL,,The safety analysis set included all participants who received at least one dose of study drug.,A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley),"A PHASE 1B/2 OPEN-LABEL STUDY TO EVALUATE SAFETY, CLINICAL ACTIVITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH OTHER CANCER IMMUNOTHERAPIES IN PATIENTS WITH ADVANCED MALIGNANCIES",TERMINATED,,PHASE1/PHASE2,409.0,ACTUAL,Pfizer,"For combination C and D the level of clinical activity observed in Cohorts C11 to C13 and D11 to D32 did not support development beyond Phase 1b. For combination F, the level of clinical activity did not warrant further enrolment. Therefore, Phase 2 was not planned.",19.0,,The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522),f,,,,f,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,INDUSTRY,,,,,,,2023,0.0
NCT03938337,,2019-05-02,2021-06-16,,2021-06-16,2019-05-03,2019-05-06,ACTUAL,2021-06-16,2021-07-09,ACTUAL,,,,2021-06-16,2021-07-09,ACTUAL,2019-10-08,ACTUAL,2019-10-08,2021-06,2021-06-30,2020-04-03,ACTUAL,2020-04-03,2020-04-03,ACTUAL,2020-04-03,,INTERVENTIONAL,,study terminated prematurely due to toxicity from other trials with this combination,Abemaciclib and Pembrolizumab in Metastatic or Recurrent Head and Neck Cancer,Clinical Trial of Abemaciclib in Combination With Pembrolizumab in Patients With Metastatic or Recurrent Head and Neck Cancer,TERMINATED,,PHASE2,1.0,ACTUAL,University of Alabama at Birmingham,,2.0,,"Sponsor terminated study due to higher incidence of pulmonary toxicity than expected, including death",f,,,,t,t,f,,,t,,,As long as study record is posted on CT.gov,To Be Determined,,YES,To Be Determined,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,OTHER,,,,,,,2020,0.0
NCT04116632,,2019-10-03,,,2020-05-14,2019-10-03,2019-10-04,ACTUAL,,,,,,,2020-05-14,2020-05-15,ACTUAL,2019-09-30,ACTUAL,2019-09-30,2020-05,2020-05-31,2020-02-10,ACTUAL,2020-02-10,2020-02-10,ACTUAL,2020-02-10,,INTERVENTIONAL,,,A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults,A Multiple Dose Pharmacokinetic/Pharmacodynamic and Safety and Tolerability Study of BMS-963272 in Obese But Otherwise Healthy Adults,COMPLETED,,PHASE1,36.0,ACTUAL,Bristol-Myers Squibb,,3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 07:11:01.772078,2024-10-16 07:11:01.772078,INDUSTRY,,,,,,,2020,1.0
NCT05270460,,2022-02-25,2023-05-22,,2023-06-28,2022-02-25,2022-03-08,ACTUAL,2023-06-28,2023-07-21,ACTUAL,,,,2023-06-28,2023-07-21,ACTUAL,2022-03-09,ACTUAL,2022-03-09,2023-06,2023-06-30,2022-10-06,ACTUAL,2022-10-06,2022-09-29,ACTUAL,2022-09-29,,INTERVENTIONAL,MOMENTUM,,"Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis","A Phase 2A, Placebo-controlled, Randomized, Dose Response Study of the Safety, Pharmacokinetics and Efficacy of PCS12852 on Gastric Emptying Rate Assessed by 13C Spirulina GEBT in Patients With Moderate to Severe Gastroparesis",COMPLETED,,PHASE2,25.0,ACTUAL,Processa Pharmaceuticals,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,INDUSTRY,,,,,,,2022,1.0
NCT02457910,,2015-05-21,2020-02-17,,2022-08-18,2015-05-26,2015-05-29,ESTIMATED,2020-04-27,2020-05-07,ACTUAL,,,,2022-08-18,2022-08-22,ACTUAL,2015-06,ACTUAL,2015-06-30,2022-08,2022-08-31,2022-08-08,ACTUAL,2022-08-08,2018-12,ACTUAL,2018-12-31,,INTERVENTIONAL,,ER/PR+ or TNBC AR+ women with breast cancer,Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer,"A Phase Ib/II Trial of Taselisib (GDC-0032), a PI3K Inhibitor, in Combination With Enzalutamide in Patients With Androgen Receptor Positive Triple Negative Metastatic Breast Cancer",TERMINATED,,PHASE1/PHASE2,30.0,ACTUAL,Vanderbilt-Ingram Cancer Center,,7.0,,Interim analysis - toxicity,f,,,,t,,,,,,,,,,,,,2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,OTHER,,,,,,,2022,0.0
NCT03115489,,2017-04-10,,,2021-05-18,2017-04-10,2017-04-14,ACTUAL,,,,,,,2021-05-18,2021-05-21,ACTUAL,2017-05-04,ACTUAL,2017-05-04,2021-05,2021-05-31,2021-05-18,ACTUAL,2021-05-18,2019-12-31,ACTUAL,2019-12-31,,INTERVENTIONAL,,,Efficacy of Ketamine Infusion Compared With Traditional Anti-epileptic Agents in Refractory Status Epilepticus,Efficacy of Ketamine Infusion Compared With Traditional Anti-epileptic Agents in Refractory Status Epilepticus- a Pilot Study,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,University of Alabama at Birmingham,,2.0,,"Low eligibility of patients, no successful recruitment",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 07:11:01.772078,2024-10-16 07:11:01.772078,OTHER,,,,,,,2021,0.0
NCT02864953,,2016-07-12,2023-12-19,,2024-04-26,2016-08-09,2016-08-12,ESTIMATED,2023-12-19,2024-01-09,ACTUAL,,,,2024-04-26,2024-04-30,ACTUAL,2018-08-29,ACTUAL,2018-08-29,2024-04,2024-04-30,2023-08-18,ACTUAL,2023-08-18,2023-08-18,ACTUAL,2023-08-18,,INTERVENTIONAL,CHARM,The Intent-to-treat (ITT) population included all randomized participants.,Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction,"Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction",TERMINATED,,PHASE3,535.0,ACTUAL,"Remedy Pharmaceuticals, Inc.","Early termination of trial due to operational challenges and other strategic considerations, not for efficacy or safety reasons.",2.0,,"Early completed to operational challenges and other strategic considerations, not for efficacy or safety reasons",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,INDUSTRY,,,,,,,2023,0.0
NCT04109482,,2019-09-25,,,2024-07-19,2019-09-27,2019-09-30,ACTUAL,,,,,,,2024-07-19,2024-07-22,ACTUAL,2020-02-17,ACTUAL,2020-02-17,2023-06,2023-06-30,2023-05-17,ACTUAL,2023-05-17,2023-05-17,ACTUAL,2023-05-17,,INTERVENTIONAL,,,Trial to Evaluate the Safety and Efficacy of MB-102 in Patients With BPDCN.,"A Phase 1/2, Open Label, Multicenter Trial to Assess the Safety and Efficacy of MB-102 in Patients With Relapsed or Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm",TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,Mustang Bio,,1.0,,Business reasons.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 21:22:01.437344,2024-10-14 21:22:01.437344,INDUSTRY,,,,,,,2023,0.0
NCT03500549,,2018-04-10,2021-10-27,2020-07-21,2022-03-01,2018-04-10,2018-04-18,ACTUAL,2022-03-01,2022-03-25,ACTUAL,2022-03-01,2022-03-25,ACTUAL,2022-03-01,2022-03-25,ACTUAL,2018-06-14,ACTUAL,2018-06-14,2022-03,2022-03-31,2020-08-13,ACTUAL,2020-08-13,2019-11-14,ACTUAL,2019-11-14,,INTERVENTIONAL,,The intent-to-treat (ITT) set included all randomized subjects.,Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH),"A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)",COMPLETED,,PHASE3,80.0,ACTUAL,"Apellis Pharmaceuticals, Inc.",,2.0,,,,,,,t,t,f,,,,,,,,,,,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,INDUSTRY,,,,,,,2020,1.0
NCT04063124,,2019-08-01,2023-02-03,,2023-02-03,2019-08-16,2019-08-21,ACTUAL,2023-02-03,2023-03-06,ACTUAL,,,,2023-02-03,2023-03-06,ACTUAL,2020-02-14,ACTUAL,2020-02-14,2023-02,2023-02-28,2023-01-30,ACTUAL,2023-01-30,2021-12-10,ACTUAL,2021-12-10,,INTERVENTIONAL,SToMP-AD,Five participants enrolled in the intervention,Senolytic Therapy to Modulate Progression of Alzheimer's Disease,Pilot Study to Investigate the Safety and Feasibility of Senolytic Therapy to Modulate Progression of Alzheimer's Disease (SToMP-AD),COMPLETED,,PHASE1/PHASE2,5.0,ACTUAL,The University of Texas Health Science Center at San Antonio,,1.0,,,f,,,,t,t,f,,,,,,At study completion,Through journal publication,,YES,All IPD that underlie results in a publication,2024-10-15 19:09:42.093872,2024-10-15 19:09:42.093872,OTHER,,,,,,,2023,1.0
NCT02628626,,2015-12-01,2023-03-30,,2023-05-26,2015-12-08,2015-12-11,ESTIMATED,2023-05-26,2023-06-22,ACTUAL,,,,2023-05-26,2023-06-22,ACTUAL,2015-11,,2015-11-30,2023-05,2023-05-31,2022-04-14,ACTUAL,2022-04-14,2022-04-14,ACTUAL,2022-04-14,,INTERVENTIONAL,,,A Study of Colesevelam in Fecal Incontinence,A Placebo Controlled Study of Colesevelam in Fecal Incontinence,COMPLETED,,PHASE3,88.0,ACTUAL,Mayo Clinic,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,OTHER,,,,,,,2022,1.0
NCT03715166,,2018-10-12,,,2024-07-24,2018-10-18,2018-10-23,ACTUAL,,,,,,,2024-07-24,2024-07-25,ACTUAL,2018-09-24,ACTUAL,2018-09-24,2024-07,2024-07-31,2021-09-13,ACTUAL,2021-09-13,2021-09-13,ACTUAL,2021-09-13,,INTERVENTIONAL,,,Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children and Adolescents Aged From 7 to Less Than 18 Years Old With Autism Spectrum Disorder,"A 6-month Randomised, Double-blind, Placebo Controlled Multicentre Parallel Group Study to Evaluate Efficacy and Safety of Bumetanide 0.5mg Twice a Day Followed by an Open Label Active 6-month Treatment Period With Bumetanide (0.5mg Twice a Day) and a 6 Weeks Discontinuation Period After Treatment Stop.",TERMINATED,,PHASE3,211.0,ACTUAL,Servier,,2.0,,The 6-month efficacy analysis did not show any significant difference between bumetanide versus placebo in the treatment of ASD in the overall studied population. No unexpected safety concerns were identified.,f,,,,t,f,f,,,,,,After Marketing Authorisation in EEA or US if the study is used for the approval.,Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.,https://clinicaltrials.servier.com/,YES,"Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.",2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,INDUSTRY,,,,,,,2021,0.0
NCT03960645,,2019-05-21,2023-02-14,,2024-06-04,2019-05-21,2019-05-23,ACTUAL,2023-12-13,2024-05-28,ACTUAL,,,,2024-06-04,2024-06-14,ACTUAL,2019-06-28,ACTUAL,2019-06-28,2023-12,2023-12-31,2022-08-18,ACTUAL,2022-08-18,2022-07-21,ACTUAL,2022-07-21,,INTERVENTIONAL,,B/F/TAF: Safety analysis set included all adult participants who took at least 1 dose of study drug (B/F/TAF). Neonates: Safety analysis set included neonates who were born to women participating in the study and had been enrolled into the study as well.,"Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters","A Phase 1b, Open-label Study to Evaluate the PK, Safety and Efficacy of B/F/TAF in HIV-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters",COMPLETED,,PHASE1,62.0,ACTUAL,Gilead Sciences,,2.0,,,f,,,,f,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gileadclinicaltrials.com/transparency-policy#Commitment,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment",2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,INDUSTRY,,,,,,,2022,1.0
NCT03437720,,2018-02-13,,,2022-04-05,2018-02-13,2018-02-19,ACTUAL,,,,,,,2022-04-05,2022-04-13,ACTUAL,2019-05-23,ESTIMATED,2019-05-23,2022-04,2022-04-30,2021-08-25,ESTIMATED,2021-08-25,2021-08-25,ESTIMATED,2021-08-25,,INTERVENTIONAL,Restore,,Assessment of the Safety and Effect of SAR425899 Versus Placebo for the Treatment of Non-alcoholic Fatty Liver Disease,"A 52-week Double-blind, Randomized, Placebo-controlled, Phase 2 Study to Assess the Efficacy and Safety of SAR425899 for the Treatment of Non-alcoholic Steatohepatitis (NASH)",WITHDRAWN,,PHASE2,0.0,ACTUAL,Sanofi,,4.0,,"Sponsor decision to cancel TRIAL, not related to safety concern.",f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,INDUSTRY,,,,,,,2021,0.0
NCT01905657,,2013-07-18,2016-09-15,,2021-09-13,2013-07-18,2013-07-23,ESTIMATED,2016-11-23,2017-01-18,ESTIMATED,,,,2021-09-13,2021-10-06,ACTUAL,2013-08-09,ACTUAL,2013-08-09,2021-09,2021-09-30,2020-09-30,ACTUAL,2020-09-30,2015-09-30,ACTUAL,2015-09-30,,INTERVENTIONAL,,,Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010),A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) Versus Docetaxel in Previously Treated Subjects With Non-Small Cell Lung Cancer,COMPLETED,,PHASE2/PHASE3,1034.0,ACTUAL,Merck Sharp & Dohme LLC,,3.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,INDUSTRY,,,,,,,2020,1.0
NCT03138499,,2017-05-01,2022-02-11,,2024-01-08,2017-05-01,2017-05-03,ACTUAL,2022-03-18,2022-04-12,ACTUAL,,,,2024-01-08,2024-01-10,ACTUAL,2017-06-26,ACTUAL,2017-06-26,2024-01,2024-01-31,2021-02-22,ACTUAL,2021-02-22,2021-02-22,ACTUAL,2021-02-22,,INTERVENTIONAL,CheckMate 812,,"A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,","Randomized, Open-label, Phase 3 Trial of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Participants With Relapsed Refractory or Ineligible for Autologous Stem Cell Transplant (ASCT) Advanced Stage Classical Hodgkin Lymphoma (CheckMate 812: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 812)",TERMINATED,,PHASE3,23.0,ACTUAL,Bristol-Myers Squibb,"Due to a treatment paradigm shift and subsequent low enrollment, the Sponsor chose to terminate the study and consequently there is limited data. These reasons were unrelated to any adverse events (AEs) or safety concerns.~The sample size was smaller than expected, therefore, results should be interpreted with caution. PFS, CRR, and ORR outcomes should be interpreted with caution given large confidence intervals around medians and early study closure.",2.0,,Insufficient enrollment.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,INDUSTRY,,,,,,,2021,0.0
NCT02066636,,2014-02-14,2022-09-29,,2022-09-29,2014-02-18,2014-02-19,ESTIMATED,2022-09-29,2022-10-27,ACTUAL,,,,2022-09-29,2022-10-27,ACTUAL,2014-04-09,ACTUAL,2014-04-09,2022-09,2022-09-30,2021-10-06,ACTUAL,2021-10-06,2021-10-06,ACTUAL,2021-10-06,,INTERVENTIONAL,CheckMate153,,A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen,A Phase IIIb/IV Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Systemic Regimen,COMPLETED,,PHASE3,1428.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,t,,,,f,t,f,,,,,,,,,,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,INDUSTRY,,NCT03126643,APPROVED_FOR_MARKETING,,,,2021,1.0
NCT05599815,,2022-10-26,,,2024-04-16,2022-10-26,2022-10-31,ACTUAL,,,,,,,2024-04-16,2024-04-17,ACTUAL,2023-01,ESTIMATED,2023-01-31,2024-04,2024-04-30,2023-05,ESTIMATED,2023-05-31,2023-05,ESTIMATED,2023-05-31,,INTERVENTIONAL,,,Part 1 - A Clinical Trial in Patients With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome,A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Aldeyra Therapeutics, Inc.",,1.0,,Lack of enrollment.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,INDUSTRY,,,,,,,2023,0.0
NCT05098405,,2021-09-30,,,2024-02-13,2021-10-18,2021-10-28,ACTUAL,,,,,,,2024-02-13,2024-02-15,ACTUAL,2021-10-11,ACTUAL,2021-10-11,2024-02,2024-02-29,2024-01-19,ACTUAL,2024-01-19,2024-01-19,ACTUAL,2024-01-19,,INTERVENTIONAL,,,First-in-human Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors,"A Phase 1, First-in-human, Multicenter, Open-label, Dose-escalation Study to Characterize the Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors",TERMINATED,,PHASE1,46.0,ACTUAL,Molecular Partners AG,,2.0,,"After completion of the dose-escalation part of the study, the safety profile of MP0317 in monotherapy is considered adequately characterized in the dose-escalation part of the study.",f,,,,f,f,f,,,,,,,,,,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,INDUSTRY,,,,,,,2024,0.0
NCT04705051,,2021-01-08,2022-07-05,,2022-10-03,2021-01-08,2021-01-12,ACTUAL,2022-10-03,2022-10-06,ACTUAL,,,,2022-10-03,2022-10-06,ACTUAL,2021-02-09,ACTUAL,2021-02-09,2022-10,2022-10-31,2021-07-13,ACTUAL,2021-07-13,2021-07-13,ACTUAL,2021-07-13,,INTERVENTIONAL,STAGED-PKD-EXT,Analysis was performed on enrolled population which included all participants allocated to an intervention kit by interactive response technology (IRT) regardless of whether the intervention was received or not.,Long-term Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) With Venglustat,"Multicenter, Open-label, Extension Study to Characterize the Long-term Efficacy and Safety of Early Versus Delayed Treatment With Venglustat (GZ/SAR402671) in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)",TERMINATED,,PHASE3,24.0,ACTUAL,Sanofi,The study was terminated prematurely by the Sponsor following a decision to terminate the parent study EFC15392. Termination decision was due to lack of efficacy in ADPKD population and not linked to safety findings with venglustat.,1.0,,LTS15823 (long-term extension of the EFC15392 study) was stopped after protocol specified interim analysis for futility of the parent EFC15392 study met the prespecified stopping rule based on the primary outcome measure.,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,INDUSTRY,,,,,,,2021,0.0
NCT05430555,,2022-06-01,,,2024-02-05,2022-06-23,2022-06-24,ACTUAL,,,,,,,2024-02-05,2024-02-07,ACTUAL,2022-07-29,ACTUAL,2022-07-29,2024-02,2024-02-29,2024-01-08,ACTUAL,2024-01-08,2024-01-08,ACTUAL,2024-01-08,,INTERVENTIONAL,IMAG1NE,,"A Phase 1/ 2, First-in-Human, Open-Label, Accelerated-Titration, Two-Part Clinical Trial of TK-8001 in Patients With HLA-A*02:01 Genotype and Advanced-Stage/ Metastatic MAGE-A1+ Solid Tumors","A Phase 1/2, First-in-Human, Open-Label, Accelerated-Titration, Two-Part Clinical Trial of TK-8001 (MAGE-A1-Directed TCR-Transduced Autologous CD8+ T-cells) in Patients With HLA-A*02:01 Genotype and Advanced-Stage/Metastatic, MAGE-A1+ Solid Tumors That Either Have No Further Approved Therapeutic Alternative(s) or Are Not Eligible for Them or Are in a Non- Curable State and Have Received a Minimum of Two Lines of Systemic Therapy",TERMINATED,,PHASE1/PHASE2,23.0,ACTUAL,T-knife GmbH,,1.0,,Sponsor decision.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,INDUSTRY,,,,,,,2024,0.0
NCT03119038,,2017-04-10,,,2022-10-25,2017-04-13,2017-04-18,ACTUAL,,,,,,,2022-10-25,2022-10-27,ACTUAL,2016-04-30,ESTIMATED,2016-04-30,2022-10,2022-10-31,2022-10-25,ACTUAL,2022-10-25,2022-10-25,ACTUAL,2022-10-25,,INTERVENTIONAL,,,Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Replacement,"Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Arthroplasty: A Prospective, Blinded, Randomized Controlled Study",WITHDRAWN,,PHASE4,0.0,ACTUAL,Rush University Medical Center,,2.0,,Investigator no longer actively pursuing this study.,f,,,,f,,,,,,,,,,,NO,,2024-10-16 07:11:01.772078,2024-10-16 07:11:01.772078,OTHER,,,,,,,2022,0.0
NCT04231279,,2020-01-09,,,2024-04-01,2020-01-13,2020-01-18,ACTUAL,,,,,,,2024-04-01,2024-04-03,ACTUAL,2022-01-28,ACTUAL,2022-01-28,2024-04,2024-04-30,2023-06-15,ACTUAL,2023-06-15,2023-06-15,ACTUAL,2023-06-15,,INTERVENTIONAL,,,Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency,A Phase II Study to Identify the Role of Exocrine Pancreatic Insufficiency in Pediatric Patients With Abdominal Pain (RAP) Who Are Undergoing Upper Endoscopy Using Synthetic Human Secretin,TERMINATED,,PHASE3,27.0,ACTUAL,"Orlando Health, Inc.",,2.0,,Data collection discontinuity and sponsor reallocation of study resources to manufacturing,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,OTHER,,,,,,,2023,0.0
NCT03973021,,2019-05-29,,,2020-10-13,2019-05-31,2019-06-04,ACTUAL,,,,,,,2020-10-13,2020-10-19,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2019-05,2019-05-31,2020-07-01,ACTUAL,2020-07-01,2020-05-20,ACTUAL,2020-05-20,,INTERVENTIONAL,,,Very Small Embryonic-like Stem Cells for Erectile Dysfunction,Autologous Very Small Embryonic-like Stem Cells(VSELs) for Organic Erectile Dysfunction,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Fuda Cancer Hospital, Guangzhou",,4.0,,Policy changes have contributed to the failure to carry out smoothly,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,OTHER,,,,,,,2020,0.0
NCT03379259,,2017-12-11,2021-09-03,,2021-10-12,2017-12-15,2017-12-20,ACTUAL,2021-10-12,2021-11-09,ACTUAL,,,,2021-10-12,2021-11-09,ACTUAL,2017-11-27,ACTUAL,2017-11-27,2021-10,2021-10-31,2020-09-08,ACTUAL,2020-09-08,2020-09-08,ACTUAL,2020-09-08,,INTERVENTIONAL,,,Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors,"Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-PD-L1 Monoclonal Antibody BGB-A333 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,39.0,ACTUAL,BeiGene,Phase 2A of the study was not initiated nor conducted since BGB-A333 as a monotherapy treatment beyond the completion of dose escalation in Phase 1A was not pursued.,4.0,,Study Was Terminated Early,f,,,,f,f,f,,,,,,,,,YES,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,INDUSTRY,,,,,,,2020,0.0
NCT05105061,,2021-10-22,,,2022-03-24,2021-10-22,2021-11-03,ACTUAL,,,,,,,2022-03-24,2022-04-05,ACTUAL,2022-02,ESTIMATED,2022-02-28,2022-03,2022-03-31,2022-03-24,ACTUAL,2022-03-24,2022-03-24,ACTUAL,2022-03-24,,INTERVENTIONAL,,,Intramuscular Ketamine for Suicidal Ideation,Intramuscular Ketamine Administration for the Treatment of Acute Suicidal Ideation With Concurrent EEG Monitoring,WITHDRAWN,,PHASE2,0.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,2.0,,PI leaving institution,f,,,,t,t,f,,,f,,,Beginning 3 months and ending 5 years following article publication.,Researchers who provide a methodologically sound proposal. Any purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data will be made available the completion of the study.,,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).",2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,OTHER,,,,,,,2022,0.0
NCT03407976,,2018-01-17,,,2020-07-13,2018-01-17,2018-01-23,ACTUAL,,,,,,,2020-07-13,2020-07-15,ACTUAL,2018-06-19,ACTUAL,2018-06-19,2020-07,2020-07-31,2020-07-02,ACTUAL,2020-07-02,2019-08-19,ACTUAL,2019-08-19,,INTERVENTIONAL,APPEASE,,Apatinib With Pembrolizumab in Previously Treated Advanced Malignancies,A Phase I/II Open Label Study of the Safety and Efficacy of Apatinib Administered to Patients With Advanced Malignancies to Improve Sensitivity to Pembrolizumab in the Second- or Later-line Setting (APPEASE),TERMINATED,,PHASE1,5.0,ACTUAL,University of Utah,,1.0,,Funding source withdrew financial support prior to start of Phase II portion of study,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,OTHER,,,,,,,2020,0.0
NCT03056378,,2017-01-13,,,2019-12-23,2017-02-14,2017-02-17,ACTUAL,,,,,,,2019-12-23,2019-12-26,ACTUAL,2019-10,ESTIMATED,2019-10-31,2019-12,2019-12-31,2021-06,ESTIMATED,2021-06-30,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,Pooled RBCs,,"POOLED Red Blood Cells Prepared From Pooling 5 Leukoreduced, Irradiated RBC Units",Phase I Clinical Trial of Pooled Red Blood Cells for Transfusion,WITHDRAWN,,PHASE1,0.0,ACTUAL,New York Blood Center,,2.0,,No patients enrolled. Study withdrawn.,f,,,,,t,f,,,,,,,,,,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,OTHER,,,,,,,2021,0.0
NCT05128539,,2021-10-27,,,2024-03-25,2021-11-19,2021-11-22,ACTUAL,,,,,,,2024-03-25,2024-03-26,ACTUAL,2022-02-10,ACTUAL,2022-02-10,2021-10,2021-10-31,2023-11-10,ACTUAL,2023-11-10,2023-11-10,ACTUAL,2023-11-10,,INTERVENTIONAL,,,A Study Explore JS001+JS002 in Patients With Advanced Cancer,"A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Recombinant Humanized Anti-PCSK9 Monoclonal Antibody (JS002) Combined With Toripalimab in Patients With Advanced Cancer",TERMINATED,,PHASE1,9.0,ACTUAL,"Shanghai Junshi Bioscience Co., Ltd.",,1.0,,"The regimen of JS002 75\~300mg Q3W has been completed, and the combination therapy is well tolerated and safe. However, considering that the efficacy did not reach the preset, it is recommended to terminate the trial in advance.",f,,,,f,f,f,,,,,,,,,,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,OTHER,,,,,,,2023,0.0
NCT05411679,,2022-05-25,,,2023-06-09,2022-06-06,2022-06-09,ACTUAL,,,,,,,2023-06-09,2023-06-12,ACTUAL,2023-04,ESTIMATED,2023-04-30,2023-06,2023-06-30,2024-12,ESTIMATED,2024-12-31,2024-08,ESTIMATED,2024-08-31,,INTERVENTIONAL,,,EP0057 in Combination With Olaparib in Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer,"A Phase 2 Multi-arm, Open Label Study to Assess the Safety and Efficacy of EP0057 in Combination With Olaparib in Defined Populations of Patients With Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer",WITHDRAWN,,PHASE2,0.0,ACTUAL,Ellipses Pharma,,2.0,,Futility analysis decision to terminate EP0057 compound and all Ellipses sponsored studies involving EP0057.,f,,,,,t,f,,,t,,,,,,,,2024-10-15 10:12:16.144565,2024-10-15 10:12:16.144565,INDUSTRY,,,,,,,2024,0.0
NCT03884842,,2019-03-18,,,2023-01-18,2019-03-19,2019-03-21,ACTUAL,,,,,,,2023-01-18,2023-01-20,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2023-01,2023-01-31,2023-01-17,ACTUAL,2023-01-17,2022-10-12,ACTUAL,2022-10-12,,INTERVENTIONAL,,,Dupilumab on Airway Hyper-responsiveness and Ventilation Heterogeneity in Patients With Asthma.,"A Two-arm, Placebo-controlled Randomized Clinical Trial to Evaluate the Effect of Dupilumab on Airway Hyper-responsiveness and Ventilation Heterogeneity in Patients With Asthma With a T2 Immune Signature",COMPLETED,,PHASE3,24.0,ACTUAL,McMaster University,,2.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,OTHER,,,,,,,2023,1.0
NCT05036837,,2021-06-16,,,2021-09-06,2021-09-06,2021-09-08,ACTUAL,,,,,,,2021-09-06,2021-09-08,ACTUAL,2018-02-01,ACTUAL,2018-02-01,2021-09,2021-09-30,2022-03-01,ESTIMATED,2022-03-01,2020-03-01,ACTUAL,2020-03-01,,INTERVENTIONAL,OZOPROMAF,,Infiltration of Medical Ozone for the Treatment of Medication-Related Osteonecrosis of the Jaws (MRONJ),OZOPROMAF: Validation Study of the Use of Ozonotherapy in Mronj Management- Protocol of Ozone by Infiltrations in Patients With Osteonecrosis of the Jaws Drug Related,SUSPENDED,,PHASE1/PHASE2,50.0,ACTUAL,University of Palermo,,1.0,,DUE TO PANDEMIC CONDITIONS,f,,,,,t,f,,,t,,,,,,YES,Patients included in our study are selected due to their non-eligibility to the standard treatment (conservative/medical for long term or surgical alone) for unstable systemic conditions or unaccepted consent due to extensive proposed approach due to the advanced disease.,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,OTHER,,,,,,,2022,0.0
NCT04246866,,2020-01-06,,,2021-02-09,2020-01-28,2020-01-29,ACTUAL,,,,,,,2021-02-09,2021-02-11,ACTUAL,2019-12-19,ACTUAL,2019-12-19,2021-02,2021-02-28,2020-10-21,ACTUAL,2020-10-21,2020-10-21,ACTUAL,2020-10-21,,INTERVENTIONAL,,,First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration,"A Phase 1, Multicenter, Open-label, Single-dose, Dose-escalation Study in Patients With Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD) to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of Intravitreal Injections of GEM103",COMPLETED,,PHASE1,12.0,ACTUAL,"Gemini Therapeutics, Inc.",,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,INDUSTRY,,,,,,,2020,1.0
NCT02747537,,2016-04-19,,,2019-09-05,2016-04-19,2016-04-21,ESTIMATED,,,,,,,2019-09-05,2019-09-09,ACTUAL,2016-06-24,ACTUAL,2016-06-24,2019-09,2019-09-30,2020-02-29,ESTIMATED,2020-02-29,2020-01-31,ESTIMATED,2020-01-31,,INTERVENTIONAL,,,Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors With Sorafenib in Combination With Irinotecan,Phase 2 Clinical Trial Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors With the Genomically-Targeted Agent Sorafenib in Combination With Irinotecan,WITHDRAWN,,PHASE2,0.0,ACTUAL,Washington University School of Medicine,,1.0,,Could not recruit participants for the study,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,OTHER,,,,,,,2020,0.0
NCT02773732,,2016-05-12,2022-05-19,,2022-07-05,2016-05-13,2016-05-16,ESTIMATED,2022-07-05,2022-08-05,ACTUAL,,,,2022-07-05,2022-08-05,ACTUAL,2016-12-16,ACTUAL,2016-12-16,2022-07,2022-07-31,2021-11-15,ACTUAL,2021-11-15,2021-09-07,ACTUAL,2021-09-07,,INTERVENTIONAL,,,Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML)(UF-AML-CE-101),A Phase Ib/II Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML),TERMINATED,,PHASE1/PHASE2,11.0,ACTUAL,University of Florida,,3.0,,slow enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,OTHER,,,,,,,2021,0.0
NCT03683576,,2018-09-11,2021-07-23,,2021-08-20,2018-09-21,2018-09-25,ACTUAL,2021-08-19,2021-08-23,ACTUAL,,,,2021-08-20,2021-09-16,ACTUAL,2018-10-22,ACTUAL,2018-10-22,2021-08,2021-08-31,2020-08-18,ACTUAL,2020-08-18,2020-07-23,ACTUAL,2020-07-23,,INTERVENTIONAL,,Intent to Treat (ITT) Population: all participants who were randomized and received at least 1 dose of study treatment,GB001 in Adult Subjects With Moderate to Severe Asthma,"A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multi-center Study to Evaluate the Efficacy and Safety of GB001 as Maintenance Therapy in Adult Subjects With Moderate to Severe Asthma",COMPLETED,,PHASE2,481.0,ACTUAL,Gossamer Bio Inc.,,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,INDUSTRY,,,,,,,2020,1.0
NCT01729754,,2012-11-13,2018-04-10,,2022-02-23,2012-11-14,2012-11-20,ESTIMATED,2018-05-25,2018-06-27,ACTUAL,,,,2022-02-23,2022-03-08,ACTUAL,2013-02-05,ACTUAL,2013-02-05,2022-02,2022-02-28,2021-10-26,ACTUAL,2021-10-26,2015-09-28,ACTUAL,2015-09-28,,INTERVENTIONAL,reSURFACE 2,"Baseline characteristics are presented for the study arms: Tildrakizumab 200 mg, Tildrakizumab 100 mg, Placebo, Etanercept 50 mg, as per the treatments administered in Part 1 (Baseline Period).",A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011),"A 52-Week, Phase 3, Randomized, Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-011)",COMPLETED,,PHASE3,1090.0,ACTUAL,Sun Pharmaceutical Industries Limited,,4.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,INDUSTRY,,,,,,,2021,1.0
NCT04941378,,2021-06-21,,,2022-06-23,2021-06-25,2021-06-28,ACTUAL,,,,,,,2022-06-23,2022-06-27,ACTUAL,2022-05-28,ACTUAL,2022-05-28,2022-06,2022-06-30,2022-05-28,ACTUAL,2022-05-28,2022-05-28,ACTUAL,2022-05-28,,INTERVENTIONAL,,,OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer,"A Pilot, Single Dose, Open-Label Study of OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer",WITHDRAWN,,PHASE1,0.0,ACTUAL,Abramson Cancer Center at Penn Medicine,,1.0,,Due to sponsor request,f,,,,,t,t,,,,,,,,,,,2024-10-16 07:16:26.799004,2024-10-16 07:16:26.799004,OTHER,,,,,,,2022,0.0
NCT02952924,,2016-11-01,,,2022-07-07,2016-11-01,2016-11-02,ESTIMATED,,,,,,,2022-07-07,2022-07-08,ACTUAL,2016-12-14,ACTUAL,2016-12-14,2022-07,2022-07-31,2022-03-16,ACTUAL,2022-03-16,2022-03-16,ACTUAL,2022-03-16,,INTERVENTIONAL,,,"A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7049389 in Healthy Volunteers and Chronic Hepatitis B Virus (HBV) Infected Participants","A Safety, Tolerability, Pharmacokinetics and Efficacy Study of ro7049389 in: (1) Single- (With or Without Food) and Multiple- (With Midazolam) Ascending Doses in Healthy Volunteers; (2) Patients Chronically Infected With Hepatitis b Virus (3) Patients With Chronic Hepatitis B.",COMPLETED,,PHASE1,192.0,ACTUAL,Hoffmann-La Roche,,9.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,INDUSTRY,,,,,,,2022,1.0
NCT02638506,,2015-12-21,,,2020-09-02,2015-12-21,2015-12-23,ESTIMATED,,,,,,,2020-09-02,2020-09-03,ACTUAL,2016-01,,2016-01-31,2020-09,2020-09-30,2020-08-18,ACTUAL,2020-08-18,2020-08-18,ACTUAL,2020-08-18,,INTERVENTIONAL,,,RCT Evaluating Intranasal Fentanyl in the Pain Management of Children With Headaches,Randomized Controlled Trial Evaluating the Additive Value of Intranasal Fentanyl on Ibuprofen in the Pain Management of Children With Moderate to Severe Headaches,TERMINATED,,PHASE4,62.0,ACTUAL,St. Justine's Hospital,,2.0,,Covid restrictions,f,,,,f,,,,,,,,,,,NO,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,OTHER,,,,,,,2020,0.0
NCT03140670,,2017-05-03,2023-04-18,,2023-09-27,2017-05-03,2017-05-04,ACTUAL,2023-09-27,2023-09-28,ACTUAL,,,,2023-09-27,2023-09-28,ACTUAL,2017-09-05,ACTUAL,2017-09-05,2023-09,2023-09-30,2023-08-07,ACTUAL,2023-08-07,2020-10-29,ACTUAL,2020-10-29,,INTERVENTIONAL,,"Patients had locally advanced or metastatic pancreatic cancer (neuroendocrine excluded); and had a confirmed pathogenic or likely pathogenic germline or somatic variant in BRCA1, BRCA2, or PALB2. Patients were required to have received at least 16 weeks of platinum-based chemotherapy for locally advanced or metastatic disease without evidence of platinum resistance.","Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy","A Phase 2, Open Label Study of Rucaparib in Patients With Advanced Pancreatic Cancer and a Known Deleterious Germline or Somatic BRCA or PALB2 Mutation",TERMINATED,,PHASE2,46.0,ACTUAL,Abramson Cancer Center at Penn Medicine,,1.0,,Loss of funding,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,OTHER,,,,,,,2023,0.0
NCT01383044,,2011-06-16,,,2020-11-19,2011-06-27,2011-06-28,ESTIMATED,,,,,,,2020-11-19,2020-11-20,ACTUAL,2011-07-08,ACTUAL,2011-07-08,2020-11,2020-11-30,2020-06-30,ACTUAL,2020-06-30,2015-07-30,ACTUAL,2015-07-30,,INTERVENTIONAL,,,Banding Ligation With Carvedilol Versus Carvedilol for the Prevention of First Bleeding,Banding Ligation With Carvedilol vs. Carvedilol for the Prevention of First Bleeding in Cirrhotics With Moderate Varices,TERMINATED,,PHASE4,65.0,ACTUAL,E-DA Hospital,,2.0,,slow enrollment,f,,,,t,,,,,,,,,,,,,2024-10-16 07:16:26.799004,2024-10-16 07:16:26.799004,OTHER,,,,,,,2020,0.0
NCT02738450,,2016-04-01,2021-07-06,,2021-09-21,2016-04-11,2016-04-14,ESTIMATED,2021-08-25,2021-09-21,ACTUAL,,,,2021-09-21,2021-10-15,ACTUAL,2016-03,ACTUAL,2016-03-31,2021-09,2021-09-30,2020-06,ACTUAL,2020-06-30,2020-06,ACTUAL,2020-06-30,,INTERVENTIONAL,3-Star,The data of the 20 subjects who have signed the informed consent (ie including the screen failure subject) have been considered.,"Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome","A Phase Ib Multi-Center, Double-Blind, Randomized, Placebo-Controlled Dose Escalation Study of the Safety, Tolerability and Immunogenicity of ACI-24 in Adults With Down Syndrome",COMPLETED,,PHASE1,20.0,ACTUAL,AC Immune SA,"The study included a limited number of subjects, and, as a consequence, was not powered on cognition and clinical efficacy outcomes.",3.0,,,f,,,,t,,,,,,,,,"These clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research and will be provided after review and approval of their research proposal, their Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). Data sharing shall be in accordance with ADCS' data sharing plan in its grant application and applicable NIH policy in effect at the time of the NIH award.",https://www.adcs.org/,YES,"Access to de-identified, individual and trial -level data (analysis datasets), and other information (e.g., protocols) will be provided.",2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,INDUSTRY,,,,,,,2020,1.0
NCT04051047,,2019-08-07,,,2019-11-25,2019-08-07,2019-08-09,ACTUAL,,,,,,,2019-11-25,2019-11-27,ACTUAL,2019-11-30,ESTIMATED,2019-11-30,2019-11,2019-11-30,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma,An Early Phase 1 Trial of Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Michigan Rogel Cancer Center,,1.0,,Withdrawn by Principal Investigator,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,OTHER,,,,,,,2021,0.0
NCT04768569,,2020-12-04,,,2023-10-04,2021-02-23,2021-02-24,ACTUAL,,,,,,,2023-10-04,2023-10-06,ACTUAL,2021-10-04,ACTUAL,2021-10-04,2023-10,2023-10-31,2023-09-29,ACTUAL,2023-09-29,2023-09-29,ACTUAL,2023-09-29,,INTERVENTIONAL,PINIHL-AET,,Noise-Induced Hearing Loss-Acute Exposure Treatment,Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment,TERMINATED,,PHASE2,24.0,ACTUAL,Washington University School of Medicine,,3.0,,PINIHL Program terminated by DoD,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,OTHER,,,,,,,2023,0.0
NCT03938272,,2019-05-03,2021-10-06,,2021-11-11,2019-05-03,2019-05-06,ACTUAL,2021-11-11,2021-12-08,ACTUAL,,,,2021-11-11,2021-12-08,ACTUAL,2019-03-14,ACTUAL,2019-03-14,2021-11,2021-11-30,2021-07-14,ACTUAL,2021-07-14,2021-07-14,ACTUAL,2021-07-14,,INTERVENTIONAL,ePHex-OLE,,An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria,An Open-label Single-arm Treatment Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact for Patients With Primary Hyperoxaluria Who Completed Study OC5-DB-02,TERMINATED,,PHASE3,22.0,ACTUAL,OxThera,,1.0,,"Parent, pivotal study (OC5-DB-02) did not meet primary endpoint. No safety concerns for early termination.",f,,,,,t,f,,,,,,,,,NO,,2024-10-15 19:15:56.423293,2024-10-15 19:15:56.423293,INDUSTRY,,,,,,,2021,0.0
NCT03678792,,2018-09-17,,,2019-10-31,2018-09-18,2018-09-20,ACTUAL,,,,,,,2019-10-31,2019-11-05,ACTUAL,2019-11-15,ESTIMATED,2019-11-15,2019-10,2019-10-31,2020-10-25,ESTIMATED,2020-10-25,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,Comparison of Three Opioid Detoxification Treatment Regimens,Time to Detox: A Patient-Centered Comparison of Length of Detoxification Treatment and Time to Naltrexone Maintenance Therapy in Opioid-Dependent Individuals,WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Alabama at Birmingham,,3.0,,Infeasible to conduct at this time.,f,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,OTHER,,,,,,,2020,0.0
NCT03737110,,2018-10-30,2021-05-25,,2023-08-14,2018-11-08,2018-11-09,ACTUAL,2021-06-21,2021-07-13,ACTUAL,,,,2023-08-14,2023-09-06,ACTUAL,2019-01-07,ACTUAL,2019-01-07,2023-08,2023-08-31,2022-06-30,ACTUAL,2022-06-30,2020-05-29,ACTUAL,2020-05-29,,INTERVENTIONAL,RHAPSODY,All participants entering the double-blind Randomized Withdrawal Treatment Period.,Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis,"Phase 3, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study With Open-label Extension, to Assess the Efficacy and Safety of Rilonacept Treatment in Subjects With Recurrent Pericarditis",COMPLETED,,PHASE3,86.0,ACTUAL,"Kiniksa Pharmaceuticals International, plc",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,INDUSTRY,,,,,,,2022,1.0
NCT02338999,,2015-01-14,2021-07-12,,2021-08-23,2015-01-14,2015-01-15,ESTIMATED,2021-08-23,2021-09-14,ACTUAL,,,,2021-08-23,2021-09-14,ACTUAL,2015-06-18,ACTUAL,2015-06-18,2020-07-14,2020-07-14,2020-07-14,ACTUAL,2020-07-14,2020-07-14,ACTUAL,2020-07-14,,INTERVENTIONAL,,,Role of PPAR-y Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE),The Role of PPAR-Gamma Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE),COMPLETED,,PHASE1/PHASE2,88.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,NIH,,,,,,,2020,1.0
NCT04588792,,2020-10-14,,,2023-12-04,2020-10-14,2020-10-19,ACTUAL,,,,,,,2023-12-04,2023-12-11,ACTUAL,2021-04-16,ACTUAL,2021-04-16,2023-12,2023-12-31,2023-04-30,ACTUAL,2023-04-30,2023-02-01,ACTUAL,2023-02-01,,INTERVENTIONAL,FaST-1,,Furosemide as Supportive Therapy for COVID-19 Respiratory Failure,Nebulized Furosemide for Pulmonary Inflammation in Intubated Patients With COVID-19 - A Phase 2/3 Study,TERMINATED,,PHASE2/PHASE3,40.0,ACTUAL,Queen's University,,2.0,,Lack of recruitment due to decline in critically ill Covid-19 patients,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,OTHER,,,,,,,2023,0.0
NCT04783766,,2021-03-03,,,2021-09-12,2021-03-04,2021-03-05,ACTUAL,,,,,,,2021-09-12,2021-09-17,ACTUAL,2021-04-10,ACTUAL,2021-04-10,2021-09,2021-09-30,2021-08-05,ACTUAL,2021-08-05,2021-08-05,ACTUAL,2021-08-05,,INTERVENTIONAL,,,"Safety, Tolerability and Pharmacokinetics Study of CK-3773274","A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CK-3773274 in Healthy Chinese Subjects",COMPLETED,,PHASE1,28.0,ACTUAL,"Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.",,4.0,,,f,,,,,t,f,,,t,,,,,,,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,INDUSTRY,,,,,,,2021,1.0
NCT00362219,,2006-08-08,,,2022-04-27,2006-08-08,2006-08-09,ESTIMATED,,,,,,,2022-04-27,2022-05-03,ACTUAL,2022-01,ESTIMATED,2022-01-31,2022-04,2022-04-30,2024-12,ESTIMATED,2024-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Topical Morphine for Analgesia in Patients With Skin Grafts,Topical Morphine for Analgesia in Patients With Skin Grafts,WITHDRAWN,,PHASE3,0.0,ACTUAL,Rambam Health Care Campus,,4.0,,no patients were recrueted,f,,,,,f,f,,,,,,,,,,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,OTHER,,,,,,,2024,0.0
NCT01888484,,2013-06-21,2021-03-04,,2021-07-26,2013-06-25,2013-06-27,ESTIMATED,2021-07-26,2021-08-17,ACTUAL,,,,2021-07-26,2021-08-17,ACTUAL,2014-03,,2014-03-31,2021-07,2021-07-31,2020-06-09,ACTUAL,2020-06-09,2020-06-09,ACTUAL,2020-06-09,,INTERVENTIONAL,,,Study of Octanorm Subcutaneous IG in Patients With PID,"Clinical Phase III Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability and Safety of Subcutaneous Human Immunoglobulin (Octanorm 16.5%) In Patients With Primary Immunodeficiency Diseases",COMPLETED,,PHASE3,75.0,ACTUAL,Octapharma,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,INDUSTRY,,,,,,,2020,1.0
NCT01940809,,2013-09-09,,,2022-03-09,2013-09-09,2013-09-12,ESTIMATED,,,,,,,2022-03-09,2022-03-10,ACTUAL,2013-08-28,ACTUAL,2013-08-28,2022-03,2022-03-31,2022-03-04,ACTUAL,2022-03-04,2020-07-17,ACTUAL,2020-07-17,,INTERVENTIONAL,,,"Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery",A Sequential Safety and Biomarker Study of BRAF-MEK Inhibition on the Immune Response in the Context of Combined CTLA-4 Blockade and PD-1 Blockade for BRAF Mutant Melanoma,TERMINATED,,PHASE1,15.0,ACTUAL,National Cancer Institute (NCI),,8.0,,Inadequate accrual rate,f,,,,f,,,,,,,,,,,,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,NIH,,,,,,,2022,0.0
NCT04817345,,2021-03-23,,,2023-04-05,2021-03-23,2021-03-26,ACTUAL,,,,,,,2023-04-05,2023-04-07,ACTUAL,2023-04,ESTIMATED,2023-04-30,2023-04,2023-04-30,2023-04,ESTIMATED,2023-04-30,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,,,Peripheral Blood Stem Cell Collection From Patients With Sickle Cell Disease (SCD) Using Plerixafor,Peripheral Blood Stem Cell Collection From Patients With Sickle Cell Disease (SCD) Using Plerixafor,WITHDRAWN,,PHASE2,0.0,ACTUAL,St. Jude Children's Research Hospital,,1.0,,The safety and efficacy of plerixafor in adult and pediatric SCD patients was an unknown when we started. A lot more data from therapeutic trials is available. We feel that recruiting patients without a therapeutic option isn't ethically justifiable.,,,,,f,t,f,,,,,,Data will be made available at the time of article publication.,"Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.",,YES,"Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.",2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,OTHER,,,,,,,2023,0.0
NCT03619187,,2018-08-02,,,2018-11-15,2018-08-02,2018-08-07,ACTUAL,,,,,,,2018-11-15,2018-11-19,ACTUAL,2018-11-02,ESTIMATED,2018-11-02,2018-11,2018-11-30,2020-02-19,ESTIMATED,2020-02-19,2020-02-19,ESTIMATED,2020-02-19,,INTERVENTIONAL,,,An Interventional Study to Evaluate the Effect of Ivabradine on Exercise Capacity in Heart Transplant Recipients,"A Phase 3, Open-label, Multicenter Study to Evaluate the Effect of Ivabradine on Exercise Capacity in Heart Transplant Recipients With Elevated Resting Heart Rate",WITHDRAWN,,PHASE3,0.0,ACTUAL,Amgen,,1.0,,Sponsor decision,,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,INDUSTRY,,,,,,,2020,0.0
NCT04130282,,2019-10-08,,,2020-09-25,2019-10-16,2019-10-17,ACTUAL,,,,,,,2020-09-25,2020-09-29,ACTUAL,2019-09-27,ACTUAL,2019-09-27,2020-09,2020-09-30,2020-09-22,ACTUAL,2020-09-22,2020-09-22,ACTUAL,2020-09-22,,INTERVENTIONAL,,,VAC077: Safety and Immunogenicity of the Pfs25-IMX313/Matrix-M Vaccine,A Phase Ia Study to Assess Safety and Immunogenicity of the Plasmodium Falciparum Malaria Vaccine Candidate Pfs25-IMX313 in Matrix-M1 Adjuvant in Healthy Adults Living in the UK,TERMINATED,,PHASE1,1.0,ACTUAL,University of Oxford,,1.0,,Delays caused by Covid-19,f,,,,t,f,f,,,,,,,,,,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,OTHER,,,,,,,2020,0.0
NCT04163094,,2019-11-06,,,2023-06-27,2019-11-11,2019-11-14,ACTUAL,,,,,,,2023-06-27,2023-06-29,ACTUAL,2019-11-25,ACTUAL,2019-11-25,2023-06,2023-06-30,2023-06-26,ACTUAL,2023-06-26,2023-06-26,ACTUAL,2023-06-26,,INTERVENTIONAL,OLIVIA,,Ovarian Cancer Treatment With a Liposome Formulated mRNA Vaccine in Combination With (Neo-)Adjuvant Chemotherapy,Ovarian Cancer Treatment With a Liposome Formulated mRNA Vaccine in Combination With (Neo-)Adjuvant Chemotherapy,TERMINATED,,PHASE1,8.0,ACTUAL,University Medical Center Groningen,,1.0,,"Despite the extension of the original recruitment period, the target number of evaluable patients defined in the study protocol could not be reached and recruitment for the trial was stopped at that point of time.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,OTHER,,,,,,,2023,0.0
NCT03802994,,2018-12-18,2021-01-21,,2021-04-06,2019-01-11,2019-01-14,ACTUAL,2021-04-06,2021-04-30,ACTUAL,,,,2021-04-06,2021-04-30,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2021-04,2021-04-30,2020-02-28,ACTUAL,2020-02-28,2020-02-28,ACTUAL,2020-02-28,,INTERVENTIONAL,,"In Groups 1, 3,4 and 5 2 individuals per group were enrolled but did not complete the study which affected parameters of all study objectives: pre- to post-antibody and opsonophagocytic responses, B cell analysis and inflammatory markers.",Pneumococcal Conjugate Vaccine in Aging Renal Transplant,Immune Response to Pneumococcal Vaccination in Aging Renal Transplant Recipients,TERMINATED,,EARLY_PHASE1,57.0,ACTUAL,VA Office of Research and Development,Early termination leading to small numbers of enrolled subjects due to the COVID pandemic,5.0,,Due to COVID pandemic further recruitment of subjects was unethical.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,FED,,,,,,,2020,0.0
NCT03211988,,2017-07-06,,,2022-10-05,2017-07-06,2017-07-11,ACTUAL,,,,,,,2022-10-05,2022-10-07,ACTUAL,2017-12-23,ACTUAL,2017-12-23,2022-10,2022-10-31,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Entinostat Neuroendocrine (NE) Tumor,A Phase 2 Single-Arm Multicenter Study of Entinostat in Patients With Relapsed or Refractory Abdominal Neuroendocrine (NE) Tumors,TERMINATED,,PHASE2,5.0,ACTUAL,Columbia University,,1.0,,Lack of funding and drug supply,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,OTHER,,,,,,,2021,0.0
NCT04809623,,2021-03-18,2023-10-06,,2023-10-06,2021-03-19,2021-03-22,ACTUAL,2023-10-06,2024-04-05,ACTUAL,,,,2023-10-06,2024-04-05,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2023-10,2023-10-31,2022-10-18,ACTUAL,2022-10-18,2022-10-18,ACTUAL,2022-10-18,,INTERVENTIONAL,LYNX,Safety population included all participants who received at least one dose of study drug.,Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE),"A Randomized, Blinded, Placebo-Controlled, Phase 1b Study of GS-5718 in Subjects With Cutaneous Lupus Erythematosus (CLE)",TERMINATED,,PHASE1,3.0,ACTUAL,Gilead Sciences,,2.0,,Sponsor decision to terminate study.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,INDUSTRY,,,,,,,2022,0.0
NCT02278250,,2014-10-27,2022-05-24,,2023-03-14,2014-10-27,2014-10-29,ESTIMATED,2023-03-14,2023-03-16,ACTUAL,,,,2023-03-14,2023-03-16,ACTUAL,2015-01-26,ACTUAL,2015-01-26,2023-03,2023-03-31,2021-09-24,ACTUAL,2021-09-24,2021-06-16,ACTUAL,2021-06-16,,INTERVENTIONAL,,,First in Human Study of M4344 in Participants With Advanced Solid Tumors,"An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M4344 (Formerly VX-803) as a Single Agent and in Combination With Cytotoxic Chemotherapy in Participants With Advanced Solid Tumors",COMPLETED,,PHASE1,97.0,ACTUAL,EMD Serono,,18.0,,,f,,,,t,,,,,,,,,,,NO,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21",2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,INDUSTRY,,,,,,,2021,0.0
NCT05320094,,2022-04-01,,,2022-11-04,2022-04-01,2022-04-11,ACTUAL,,,,,,,2022-11-04,2022-11-08,ACTUAL,2022-04-15,ACTUAL,2022-04-15,2022-10,2022-10-31,2022-09-11,ACTUAL,2022-09-11,2022-09-11,ACTUAL,2022-09-11,,INTERVENTIONAL,,,A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants,An Open-label Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Pharmacokinetics of Mavacamten in Healthy Participants,COMPLETED,,PHASE1,45.0,ACTUAL,Bristol-Myers Squibb,,3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,INDUSTRY,,,,,,,2022,1.0
NCT02953327,,2016-10-21,,,2021-04-22,2016-10-31,2016-11-02,ESTIMATED,,,,,,,2021-04-22,2021-04-26,ACTUAL,2017-02-01,ACTUAL,2017-02-01,2021-04,2021-04-30,2020-06-15,ACTUAL,2020-06-15,2017-06-15,ACTUAL,2017-06-15,,INTERVENTIONAL,,,Testing if BCG (Bacille Calmette-Guérin) Vaccination Can Induce Innate Immune Training in Adult People Above 50 Years of Age in Guinea-Bissau,Testing if BCG (Bacille Calmette-Guérin) Vaccination Can Induce Innate Immune Training in Adult People Above 50 Years of Age in Guinea-Bissau,COMPLETED,,PHASE4,40.0,ACTUAL,Bandim Health Project,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,OTHER,,,,,,,2020,1.0
NCT03519308,,2018-04-24,2023-09-29,,2024-03-14,2018-05-07,2018-05-08,ACTUAL,2024-03-14,2024-03-15,ACTUAL,,,,2024-03-14,2024-03-15,ACTUAL,2020-07-29,ACTUAL,2020-07-29,2024-03,2024-03-31,2022-04-18,ACTUAL,2022-04-18,2022-04-18,ACTUAL,2022-04-18,,INTERVENTIONAL,,Patients with resectable epithelial-subtype pancreatic cancer,A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer,A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer,TERMINATED,,EARLY_PHASE1,3.0,ACTUAL,Abramson Cancer Center at Penn Medicine,,2.0,,The accrual goal could not be met and the drug manufacturer pulled support,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 07:16:26.799004,2024-10-16 07:16:26.799004,OTHER,,,,,,,2022,0.0
NCT04334408,,2020-04-02,,,2022-02-14,2020-04-02,2020-04-06,ACTUAL,,,,,,,2022-02-14,2022-02-28,ACTUAL,2021-12,ESTIMATED,2021-12-31,2022-02,2022-02-28,2024-12,ESTIMATED,2024-12-31,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL,A Phase II Double-Blinded Placebo Controlled Individual Subject Stepped Wedge Clinical Trial Evaluating the Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL,WITHDRAWN,,PHASE2,0.0,ACTUAL,Mayo Clinic,,2.0,,Lack of funding to support the trial.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,OTHER,,,,,,,2024,0.0
NCT05609045,,2022-10-28,,,2023-07-12,2022-11-01,2022-11-08,ACTUAL,,,,,,,2023-07-12,2023-07-14,ACTUAL,2023-06,ESTIMATED,2023-06-30,2023-07,2023-07-31,2023-12,ESTIMATED,2023-12-31,2023-08,ESTIMATED,2023-08-31,,INTERVENTIONAL,,,"A Phase 1, Randomised, Double-blinded, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of RH109 as Booster","A Phase 1, Randomised, Double-blinded, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of RH109 as Booster for Healthy Adults Who Have Received Homologous or Heterologous Vaccination With 3 Doses of COVID-19 Inactivated and/or mRNA Vaccine(s)",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Wuhan Rhegen Biotechnology Co., Ltd.",,2.0,,business strategy adjustment,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,INDUSTRY,,,,,,,2023,0.0
NCT04741074,,2021-02-02,2024-01-12,,2024-02-06,2021-02-02,2021-02-05,ACTUAL,2024-02-06,2024-02-09,ACTUAL,,,,2024-02-06,2024-02-09,ACTUAL,2021-07-23,ACTUAL,2021-07-23,2024-02,2024-02-29,2023-01-31,ACTUAL,2023-01-31,2023-01-31,ACTUAL,2023-01-31,,INTERVENTIONAL,RAISE-KT,,Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy,A RAndomized trIal Examining the Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy for Patients With Stage 4-5 CKD or Dialysis-dependent ESKD,TERMINATED,,PHASE3,15.0,ACTUAL,Geisinger Clinic,The study was terminated prematurely by the funder due to slow recruitment.,2.0,,low recruitment,f,,,,t,t,f,,,f,,,Data will become available at the time of publication of the main trial results and will be publicly available indefinitely.,The deidentified IPD will be publicly available without restrictions.,,YES,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,OTHER,,,,,,,2023,0.0
NCT03652493,,2018-07-25,,,2021-04-28,2018-08-28,2018-08-29,ACTUAL,,,,,,,2021-04-28,2021-04-30,ACTUAL,2018-09-10,ACTUAL,2018-09-10,2021-04,2021-04-30,2021-04-27,ACTUAL,2021-04-27,2021-04-27,ACTUAL,2021-04-27,,INTERVENTIONAL,PRO-CARBO,,Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway,"Multicentre, Open-label Phase 2 Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway",TERMINATED,,PHASE2,16.0,ACTUAL,Centre Francois Baclesse,,1.0,,lack of efficacy,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,OTHER,,,,,,,2021,0.0
NCT05195827,,2022-01-02,,,2023-03-16,2022-01-13,2022-01-19,ACTUAL,,,,,,,2023-03-16,2023-03-20,ACTUAL,2021-12-20,ACTUAL,2021-12-20,2023-03,2023-03-31,2022-11-30,ACTUAL,2022-11-30,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,,,Effect of PRM-125 on Ambulatory Blood Pressure,Evaluation of Once-Daily PRM125 On Ambulatory Blood Pressure in Adults With Hypertension,WITHDRAWN,,PHASE3,0.0,ACTUAL,"PRM Pharma, LLC",,1.0,,Sponsor,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,INDUSTRY,,,,,,,2022,0.0
NCT01519960,,2011-12-06,2016-07-08,,2022-10-26,2012-01-24,2012-01-27,ESTIMATED,2016-07-08,2016-08-17,ESTIMATED,,,,2022-10-26,2022-11-18,ACTUAL,2012-07-11,ACTUAL,2012-07-11,2022-10,2022-10-31,2021-10-18,ACTUAL,2021-10-18,2015-07-09,ACTUAL,2015-07-09,,INTERVENTIONAL,,,A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B,"A Phase IIIb Parallel Group, Open Label Study of Pegylated Interferon Alfa-2a Monotherapy (PEG-IFN, Ro 25-8310) Compared to Untreated Control in Children With HBeAg Positive Chronic Hepatitis B",COMPLETED,,PHASE3,165.0,ACTUAL,Hoffmann-La Roche,,4.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,INDUSTRY,,,,,,,2021,1.0
NCT03742154,,2018-11-12,2020-08-27,,2020-10-08,2018-11-12,2018-11-15,ACTUAL,2020-09-16,2020-10-09,ACTUAL,,,,2020-10-08,2020-10-28,ACTUAL,2018-12-03,ACTUAL,2018-12-03,2020-10,2020-10-31,2020-04-06,ACTUAL,2020-04-06,2020-04-06,ACTUAL,2020-04-06,,INTERVENTIONAL,,,Hollings Cancer Center Varenicline Sampling Study,A Pilot Translational Study of Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation,COMPLETED,,EARLY_PHASE1,99.0,ACTUAL,Medical University of South Carolina,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,OTHER,,,,,,,2020,1.0
NCT04984993,,2021-07-26,2023-06-23,,2023-09-18,2021-07-26,2021-08-02,ACTUAL,2023-09-18,2023-09-21,ACTUAL,,,,2023-09-18,2023-09-21,ACTUAL,2021-09-14,ACTUAL,2021-09-14,2021-07,2021-07-31,2022-07-13,ACTUAL,2022-07-13,2022-07-13,ACTUAL,2022-07-13,,INTERVENTIONAL,,Regional enrolment details are combined for both the male participants and their female partners.,Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction,"A Multi-centre, Randomised, Open-label, Home Use, Parallel Group, Clinical Investigation of Topically-applied MED3000 Gel and Oral Tadalafil (5 mg) Tablets for the Treatment of Erectile Dysfunction (ED) Over a 24 Week Period",COMPLETED,,PHASE3,116.0,ACTUAL,Futura Medical Developments Ltd.,,2.0,,,f,,,,f,f,t,t,,f,,,,,,,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,INDUSTRY,,,,,,,2022,1.0
NCT02528643,,2015-08-18,2018-10-01,,2023-04-12,2015-08-18,2015-08-19,ESTIMATED,2018-11-15,2018-11-20,ACTUAL,,,,2023-04-12,2023-04-14,ACTUAL,2015-11-09,ACTUAL,2015-11-09,2023-04,2023-04-30,2021-02-09,ACTUAL,2021-02-09,2017-10-02,ACTUAL,2017-10-02,,INTERVENTIONAL,,Full analysis set (FAS) consisted of all randomized participants regardless of whether or not participants received study drug.,A Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma",COMPLETED,,PHASE2,165.0,ACTUAL,Astellas Pharma Inc,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,INDUSTRY,,,,,,,2021,1.0
NCT04057261,,2019-07-18,,,2021-03-09,2019-08-12,2019-08-15,ACTUAL,,,,,,,2021-03-09,2021-03-10,ACTUAL,2020-11,ESTIMATED,2020-11-30,2021-03,2021-03-31,2022-11,ESTIMATED,2022-11-30,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,Lirabolic,,Effect of Liraglutide on the Metabolic Profile in Patients With Type 2 Diabetes and Cardiovascular Disease,Effect of Liraglutide on the Metabolic Profile in Patients With Type 2 Diabetes and Cardiovascular Disease,WITHDRAWN,,PHASE3,0.0,ACTUAL,RWTH Aachen University,,2.0,,"A study start is currently not foreseeable for organizational reasons. Due to the delays, research has also been focused on new compounds, which has reduced the interest in the potential results of the above-mentioned clinical trial.",f,,,,,f,f,,,,,,,,,,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,OTHER,,,,,,,2022,0.0
NCT02988973,,2016-12-08,,,2022-09-28,2016-12-08,2016-12-12,ESTIMATED,,,,,,,2022-09-28,2022-09-30,ACTUAL,2017-01-12,ACTUAL,2017-01-12,2022-09,2022-09-30,2020-03-26,ACTUAL,2020-03-26,2019-09-13,ACTUAL,2019-09-13,,INTERVENTIONAL,,,A Study of Intermittent Oral Dosing of ASP1517 in Non-Dialysis Chronic Kidney Disease Patients With Anemia,"A Phase 3 Multi-center, Randomized, Open-label, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in Non-dialysis Chronic Kidney Disease Patients With Anemia",COMPLETED,,PHASE3,334.0,ACTUAL,Astellas Pharma Inc,,3.0,,,f,,,,f,f,f,,,,,,,,,NO,Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,INDUSTRY,,,,,,,2020,1.0
NCT05016934,,2021-08-19,,,2021-08-24,2021-08-19,2021-08-23,ACTUAL,,,,,,,2021-08-24,2021-08-27,ACTUAL,2021-11-01,ESTIMATED,2021-11-01,2021-08,2021-08-31,2022-04-20,ESTIMATED,2022-04-20,2022-03-04,ESTIMATED,2022-03-04,,INTERVENTIONAL,,,Evaluation of Safety and Immunogenicity of a Novel Vaccine for Prevention of Covid-19 in Adults Previously Immunized,"Randomized Controlled-trial to Evaluate Safety, Immunogenicity and Efficacy of a Vaccine Composed of a Recombinant S1 Antigen for Prevention of Covid-19 in Adults Previously Fully Immunized With Other Vaccines",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Hospital do Coracao,,4.0,,At collaborator's request,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,OTHER,,,,,,,2022,0.0
NCT02514447,,2015-07-31,2022-02-07,2019-07-23,2022-05-12,2015-07-31,2015-08-03,ESTIMATED,2022-05-12,2022-06-09,ACTUAL,2019-07-23,2019-07-31,ACTUAL,2022-05-12,2022-06-09,ACTUAL,2015-10-05,ACTUAL,2015-10-05,2022-05,2022-05-31,2021-10-04,ACTUAL,2021-10-04,2018-09-28,ACTUAL,2018-09-28,,INTERVENTIONAL,,,Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy,Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Previously Treated Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Topotecan Chemotherapy,TERMINATED,,PHASE1/PHASE2,123.0,ACTUAL,"G1 Therapeutics, Inc.","Limitation of the trial is small numbers of subjects, since it is a Phase 2 clinical trial.~Small sample size may have reduced the ability to observe statistically significant treatment effects on secondary myelopreservation measures (i.e. occurrence of FN AEs, infections and antibiotics usage).",9.0,,Primary Analysis and survival follow up completed per protocol. Not stopped due to safety concerns.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,INDUSTRY,,,,,,,2021,0.0
NCT02097810,,2014-03-21,,,2021-06-07,2014-03-24,2014-03-27,ESTIMATED,,,,,,,2021-06-07,2021-06-09,ACTUAL,2014-07-28,ACTUAL,2014-07-28,2021-06,2021-06-30,2020-06-02,ACTUAL,2020-06-02,2020-06-02,ACTUAL,2020-06-02,,INTERVENTIONAL,STARTRK-1,,"Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations.","A Phase 1, Multicenter, Open-Label Study of Oral Entrectinib (RXDX-101) in Adult Patients With Locally Advanced or Metastatic Cancer Confirmed to be Positive for NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations",COMPLETED,,PHASE1,84.0,ACTUAL,Hoffmann-La Roche,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,INDUSTRY,,,,,,,2020,1.0
NCT03448692,,2018-02-22,2024-02-01,,2024-04-16,2018-02-22,2018-02-28,ACTUAL,2024-04-16,2024-04-18,ACTUAL,,,,2024-04-16,2024-04-18,ACTUAL,2018-10-15,ACTUAL,2018-10-15,2024-04,2024-04-30,2023-02-14,ACTUAL,2023-02-14,2023-02-14,ACTUAL,2023-02-14,,INTERVENTIONAL,PODO,Safety Analysis Set (SAS) was defined as all enrolled participants who had received at least one dose of study treatment.,A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS),"A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)",TERMINATED,,PHASE2,47.0,ACTUAL,Pfizer,,3.0,,The study was terminated due to lack of efficacy at both tested doses on 5th December 2022. The decision to terminate the study is not related to a safety concern.,f,,,,,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,INDUSTRY,,,,,,,2023,0.0
NCT04973228,,2021-07-13,2024-01-04,2023-03-07,2024-02-12,2021-07-13,2021-07-22,ACTUAL,2024-02-12,2024-03-12,ACTUAL,,2024-03-12,ACTUAL,2024-02-12,2024-03-12,ACTUAL,2021-07-08,ACTUAL,2021-07-08,2024-02,2024-02-29,2022-04-06,ACTUAL,2022-04-06,2022-04-06,ACTUAL,2022-04-06,,INTERVENTIONAL,,,Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM),"A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis",COMPLETED,,PHASE3,457.0,ACTUAL,"Arcutis Biotherapeutics, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 07:16:26.799004,2024-10-16 07:16:26.799004,INDUSTRY,,,,,,,2022,1.0
NCT04776850,,2021-02-08,,,2023-02-16,2021-02-25,2021-03-02,ACTUAL,,,,,,,2023-02-16,2023-02-21,ACTUAL,2020-12-29,ACTUAL,2020-12-29,2022-11,2022-11-30,2022-12-05,ESTIMATED,2022-12-05,2022-12-05,ACTUAL,2022-12-05,,INTERVENTIONAL,,,Pre-transplant Immunosuppression and Donor Stem Cell Transplant for the Treatment of Severe Hemoglobinopathies,Pre-Transplant Immunosuppression and Related Haploidentical Hematopoietic Cell Transplantation for Patients With Severe Hemoglobinopathies,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Competing protocol opened in Adult SCT that will include pediatric patients and is now multi-center. No patients enrolled on study.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,OTHER,,,,,,,2022,0.0
NCT04323280,,2020-03-24,,,2023-12-13,2020-03-25,2020-03-26,ACTUAL,,,,,,,2023-12-13,2023-12-19,ACTUAL,2020-02-14,ACTUAL,2020-02-14,2023-12,2023-12-31,2023-07-17,ACTUAL,2023-07-17,2023-07-17,ACTUAL,2023-07-17,,INTERVENTIONAL,Dexa-P,,Dexamethasone Compared to Non-steroidal Anti-inflammatory Drugs in the Treatment of Acute Pericarditis,Dexamethasone Compared to Non-steroidal Anti-inflammatory Drugs in the Treatment of Acute Pericarditis: a Non-inferiority Randomized Controlled Trial (Dexa-P),TERMINATED,,PHASE4,10.0,ACTUAL,Rabin Medical Center,,2.0,,Difficulty in enrollment of patients,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,OTHER,,,,,,,2023,0.0
NCT03592407,,2018-04-30,,,2022-02-21,2018-07-09,2018-07-19,ACTUAL,,,,,,,2022-02-21,2022-03-08,ACTUAL,2018-07-01,ESTIMATED,2018-07-01,2022-02,2022-02-28,2020-04,ESTIMATED,2020-04-30,2020-04,ESTIMATED,2020-04-30,,INTERVENTIONAL,,,Epacadostat and Pembrolizumab Before Surgery in Treating Participants With Stage II-III Esophageal or Gastroesophageal Cancer,A Phase 2 Trial of Neoadjuvant Pembrolizumab in Combination With Epacadostat (INCB024360) in Patients With Non-Metastatic Esophageal/Gastroesophageal Squamous Cell and Adenocarcinomas Treated With Neoadjuvant Chemoradiation: A Window-Of-Opportunity Study,WITHDRAWN,,PHASE2,0.0,ACTUAL,City of Hope Medical Center,,1.0,,Safety concerns,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,OTHER,,,,,,,2020,0.0
NCT03578029,,2018-06-14,,2022-08-18,2022-08-18,2018-06-24,2018-07-05,ACTUAL,,,,2022-08-18,2022-08-22,ACTUAL,2022-08-18,2022-08-22,ACTUAL,2019-05-22,ACTUAL,2019-05-22,2022-08,2022-08-31,2021-11-23,ACTUAL,2021-11-23,2021-09-01,ACTUAL,2021-09-01,,INTERVENTIONAL,CELEB,,Evaluation of the Safety and Efficacy Study of RGN-137 Topical Gel for Junctional and Dystrophic Epidermolysis Bullosa,"A Randomized,Single-Blind, Placebo-controlled, Self-matched Pairing, Independent Evaluated Study to Evaluate the Efficacy and Safety of RGN-137 Topical Gel in Subjects With Junctional and Dystrophic Epidermolysis Bullosa (CELEB)",TERMINATED,,PHASE2,4.0,ACTUAL,"Lenus Therapeutics, LLC",,2.0,,Business Decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,INDUSTRY,,,,,,,2021,0.0
NCT03345095,,2017-11-07,2023-12-08,,2024-07-10,2017-11-14,2017-11-17,ACTUAL,2024-01-08,2024-01-31,ACTUAL,,,,2024-07-10,2024-07-12,ACTUAL,2018-07-26,ACTUAL,2018-07-26,2024-07,2024-07-31,2023-06-30,ACTUAL,2023-06-30,2022-08-23,ACTUAL,2022-08-23,,INTERVENTIONAL,MIRAGE,,A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma,A Phase III Trial of Marizomib in Combination With Standard Temozolomide-based Radiochemotherapy Versus Standard Temozolomide-based Radiochemotherapy Alone in Patients With Newly Diagnosed Glioblastoma,COMPLETED,,PHASE3,749.0,ACTUAL,European Organisation for Research and Treatment of Cancer - EORTC,,2.0,,,,,,,t,t,f,,,,,,,,,,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,NETWORK,,,,,,,2023,0.0
NCT02562612,,2015-09-26,,,2022-06-28,2015-09-28,2015-09-29,ESTIMATED,,,,,,,2022-06-28,2022-07-01,ACTUAL,2022-10,ESTIMATED,2022-10-31,2021-03,2021-03-31,2023-10,ESTIMATED,2023-10-31,2023-10,ESTIMATED,2023-10-31,,INTERVENTIONAL,,,Study of SM-88 in Advanced Cancers,Ascending Multi-Dose Clinical Trial to Assess the Pharmacokinetics Efficacy of SM-88 Oral Administration in Breast Cancer Subjects,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Tyme, Inc",,1.0,,Study was never initiated. Never established sites or enrolled subjects.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,INDUSTRY,,,,,,,2023,0.0
NCT03784222,,2018-11-28,,,2024-04-17,2018-12-19,2018-12-21,ACTUAL,,,,,,,2024-04-17,2024-04-19,ACTUAL,2019-01-22,ACTUAL,2019-01-22,2024-04,2024-04-30,2022-11-22,ACTUAL,2022-11-22,2022-11-22,ACTUAL,2022-11-22,,INTERVENTIONAL,,,Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients,Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients,TERMINATED,,PHASE4,102.0,ACTUAL,"Sumitomo Pharma (Suzhou) Co., Ltd.",,2.0,,Company's business decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,INDUSTRY,,,,,,,2022,0.0
NCT03254927,,2017-08-17,2021-10-06,,2023-03-07,2017-08-17,2017-08-21,ACTUAL,2023-03-07,2023-04-03,ACTUAL,,,,2023-03-07,2023-04-03,ACTUAL,2018-03-27,ACTUAL,2018-03-27,2023-03,2023-03-31,2020-12-16,ACTUAL,2020-12-16,2020-09-16,ACTUAL,2020-09-16,,INTERVENTIONAL,,,A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma,"A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of CDX-3379 in Combination With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma",TERMINATED,,PHASE2,30.0,ACTUAL,Celldex Therapeutics,Study was terminated early due to unfavorable risk/benefit profile.,1.0,,Sponsor decision based on emerging risk-benefit profile,f,,,,f,t,f,,,,,,,,,,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,INDUSTRY,,,,,,,2020,0.0
NCT02156154,,2014-06-03,2020-12-22,,2021-03-25,2014-06-04,2014-06-05,ESTIMATED,2021-03-25,2021-04-20,ACTUAL,,,,2021-03-25,2021-04-20,ACTUAL,2014-12,,2014-12-31,2021-03,2021-03-31,2020-10,ACTUAL,2020-10-31,2019-03,ACTUAL,2019-03-31,,INTERVENTIONAL,,,Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications,Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications,COMPLETED,,PHASE3,580.0,ACTUAL,The Cleveland Clinic,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,OTHER,,,,,,,2020,1.0
NCT02298166,,2014-11-19,,,2021-09-28,2014-11-20,2014-11-21,ESTIMATED,,,,,,,2021-09-28,2021-10-06,ACTUAL,2016-11-17,ACTUAL,2016-11-17,2021-09,2021-09-30,2020-03-09,ACTUAL,2020-03-09,2020-03-09,ACTUAL,2020-03-09,,INTERVENTIONAL,,,Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations,"Dose-Finding Run-in Phase I Followed by a Phase III, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations",TERMINATED,,PHASE3,9.0,ACTUAL,University of Ulm,,2.0,,The manufacturer Arog Pharmaceuticals Inc has terminated the Agreement Concerning the Support of an Investigator Initiated Trial this became valid on 2020/03/09,f,,,,t,,,,,,,,,,,,,2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,OTHER,,,,,,,2020,0.0
NCT03705507,,2018-07-04,,,2023-05-09,2018-10-10,2018-10-15,ACTUAL,,,,,,,2023-05-09,2023-05-11,ACTUAL,2018-05-18,ACTUAL,2018-05-18,2023-05,2023-05-31,2023-05-03,ACTUAL,2023-05-03,2023-05-03,ACTUAL,2023-05-03,,INTERVENTIONAL,SeluDex,,International Trial of Selumetinib in Combination With Dexamethasone for the Treatment of Acute Lymphoblastic Leukaemia,International Phase I/II Expansion Trial of the MEK Inhibitor Selumetinib in Combination With Dexamethasone for the Treatment of Relapsed/Refractory RAS-pathway Mutated Paediatric and Adult Acute Lymphoblastic Leukaemia,TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,University of Birmingham,,2.0,,"Poor recruitment, due to a change in the standard of care for this patient population with the use of CAR-T cells",f,,,,t,f,f,,,,,,Data will be available within 6 months of the primary publication.,See Plan Description above.,,YES,"The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. The CRCTU is committed to responsible and controlled sharing of anonymised clinical trial data with the wider research community to maximise potential patient benefit while protecting the privacy and confidentiality of trial participants. Data anonymised in compliance with the Information Commissioners Office requirements, using a procedure based on guidelines from the MRC Methodology Hubs, will be available for sharing with researchers outside of the trials team within 6 months of the primary publication. More detailed information on the CRCTU's Data Sharing Policy and the mechanism for obtaining data can be found on the CRCTU website: https://www.birmingham.ac.uk/research/activity/mds/trials/crctu/index.aspx.",2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,OTHER,,,,,,,2023,0.0
NCT05139615,,2021-11-18,2023-09-18,,2023-11-06,2021-11-18,2021-12-01,ACTUAL,2023-11-06,2023-11-09,ACTUAL,,,,2023-11-06,2023-11-09,ACTUAL,2021-12-28,ACTUAL,2021-12-28,2023-11,2023-11-30,2022-09-19,ACTUAL,2022-09-19,2022-09-19,ACTUAL,2022-09-19,,INTERVENTIONAL,,"Full analysis set included all randomized participants, irrespective of whether they received any study treatment.","A Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Intravenous APD418 in Adult Participants With Heart Failure With Reduced Ejection Fraction","A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of APD418 in Subjects With Heart Failure With Reduced Ejection Fraction",TERMINATED,,PHASE2,22.0,ACTUAL,Pfizer,This study was terminated early due to a business decision that was not due to any safety concerns. The number of participants was smaller than originally planned and only summary statistics were therefore generated for primary and secondary outcome measures.,3.0,,Business decision,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 19:21:40.513125,2024-10-15 19:21:40.513125,INDUSTRY,,,,,,,2022,0.0
NCT03707028,,2018-10-08,,,2022-04-04,2018-10-11,2018-10-16,ACTUAL,,,,,,,2022-04-04,2022-04-11,ACTUAL,2018-10-01,ACTUAL,2018-10-01,2022-04,2022-04-30,2021-08-24,ACTUAL,2021-08-24,2021-08-24,ACTUAL,2021-08-24,,INTERVENTIONAL,,,"A Study to Evaluate Safety, Tolerability, and Efficacy Profile of Rivoceranib With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer","A Phase I/IIa Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Rivoceranib in Combination With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer",TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,Elevar Therapeutics,,1.0,,Terminated after completion of Part 1 due to a change in research plan.,f,,,,,f,f,,,f,,,,,,,,2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,INDUSTRY,,,,,,,2021,0.0
NCT03483883,,2018-03-23,,,2022-08-23,2018-03-29,2018-03-30,ACTUAL,,,,,,,2022-08-23,2022-08-26,ACTUAL,2018-03-19,ACTUAL,2018-03-19,2022-08,2022-08-31,2021-02-10,ACTUAL,2021-02-10,2020-07-22,ACTUAL,2020-07-22,,INTERVENTIONAL,,,Avelumab/Gemcitabine in Sarcomatoid RCC,A Phase I/IB Study of Avelumab in Combination With Gemcitabine for Advanced Renal Cell Carcinoma With Sarcomatoid Differentiation,TERMINATED,,PHASE1,6.0,ACTUAL,Abramson Cancer Center at Penn Medicine,,1.0,,The study was terminated due to protracted accrual and limited patient engagement in the setting of rapidly changing treatment paradigms for advanced RCC with sarcomatoid features and/or intermediate/poor risk clinical features.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 10:18:29.18885,2024-10-15 10:18:29.18885,OTHER,,,,,,,2021,0.0
NCT05079230,,2021-10-04,,,2024-04-12,2021-10-04,2021-10-15,ACTUAL,,,,,,,2024-04-12,2024-04-16,ACTUAL,2022-07-07,ACTUAL,2022-07-07,2024-04,2024-04-30,2024-04-11,ACTUAL,2024-04-11,2024-04-11,ACTUAL,2024-04-11,,INTERVENTIONAL,ENHANCE-3,,Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy",TERMINATED,,PHASE3,378.0,ACTUAL,Gilead Sciences,,2.0,,Study was terminated due to futility,t,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,INDUSTRY,,NCT05627466,NO_LONGER_AVAILABLE,,,,2024,0.0
NCT03462966,,2017-11-20,2022-02-11,,2022-08-18,2018-03-09,2018-03-13,ACTUAL,2022-08-18,2022-09-13,ACTUAL,,,,2022-08-18,2022-09-13,ACTUAL,2018-07-01,ACTUAL,2018-07-01,2022-08,2022-08-31,2021-11-19,ACTUAL,2021-11-19,2021-11-19,ACTUAL,2021-11-19,,INTERVENTIONAL,,,Rifaximin on Visceral Hypersensitivity,Effects of Rifaximin on Visceral Hypersensitivity in Irritable Bowel Syndrome,TERMINATED,,PHASE2,4.0,ACTUAL,Cedars-Sinai Medical Center,recruitment challenges and the COVID pandemic affected our enrollment as we were only able to enroll 4 participants and not all of them finished the outcome measures.,1.0,,recruitment challenges,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 19:27:40.32804,2024-10-15 19:27:40.32804,OTHER,,,,,,,2021,0.0
NCT02369549,,2015-01-13,,,2021-01-21,2015-02-17,2015-02-24,ESTIMATED,,,,,,,2021-01-21,2021-01-25,ACTUAL,2015-09,ACTUAL,2015-09-30,2021-01,2021-01-31,2020-05-15,ACTUAL,2020-05-15,2019-11,ACTUAL,2019-11-30,,INTERVENTIONAL,MPAC-CKD,,Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease,Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease,COMPLETED,,PHASE3,518.0,ACTUAL,Lawson Health Research Institute,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,OTHER,,,,,,,2020,0.0
NCT05762744,,2023-02-23,,,2023-03-06,2023-03-06,2023-03-10,ACTUAL,,,,,,,2023-03-06,2023-03-10,ACTUAL,2016-06-01,ACTUAL,2016-06-01,2023-03,2023-03-31,2022-10-31,ACTUAL,2022-10-31,2018-11-30,ACTUAL,2018-11-30,,INTERVENTIONAL,,,Pharmacogenomics of GLP1 Receptor Agonists,Pharmacogenomics of GLP1 Receptor Agonists,TERMINATED,,PHASE1,78.0,ACTUAL,"University of Maryland, Baltimore",,3.0,,We concluded that it would not be possible to meet our recruitment targets within the available budget. The study was ended when the funding ended.,f,,,,f,t,f,,,f,,,12 months after publication in a peer reviewed journal.,Must sign data transfer agreement to protect confidentiality of research participants.~Requester must be on faculty at an accredited academic institution such as a medical school.,,YES,"Subject to protection of confidential information of research participants, we will share data with qualified researchers.",2024-10-16 07:16:26.799004,2024-10-16 07:16:26.799004,OTHER,,,,,,,2022,0.0
NCT03013491,,2016-12-26,,,2022-02-07,2017-01-05,2017-01-06,ESTIMATED,,,,,,,2022-02-07,2022-02-09,ACTUAL,2017-01,,2017-01-31,2022-02,2022-02-28,2021-10-06,ACTUAL,2021-10-06,2021-10-06,ACTUAL,2021-10-06,,INTERVENTIONAL,,,PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas,"An Open-Label, Dose-Finding and Proof of Concept Study of the PD-L1 Probody™ Therapeutic , CX-072, as Monotherapy and in Combination With Yervoy (Ipilimumab) or With Zelboraf (Vemurafenib) in Subjects With Advanced or Recurrent Solid Tumors or Lymphomas",COMPLETED,,PHASE1/PHASE2,300.0,ESTIMATED,CytomX Therapeutics,,5.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 07:16:26.799004,2024-10-16 07:16:26.799004,INDUSTRY,,,,,,,2021,1.0
NCT03089606,,2017-02-24,2022-01-28,2021-12-10,2023-11-13,2017-03-17,2017-03-24,ACTUAL,2022-06-20,2022-07-14,ACTUAL,2022-06-20,2022-07-14,ACTUAL,2023-11-13,2023-11-15,ACTUAL,2017-04-19,ACTUAL,2017-04-19,2023-11,2023-11-30,2023-07-01,ACTUAL,2023-07-01,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,,,Pembrolizumab TX-naive Distant Mets Melanoma and Use of (C11-AMT) PET at Baseline as Imaging Biomarker,Pembrolizumab in Systemic Treatment-Naïve Distant Metastatic Melanoma and Exploration of Use of Baseline 11C-methyl-L-tryptophan (C11-AMT) PET Imaging as a Predictive Imaging Biomarker of Antitumor Response,COMPLETED,,PHASE2,27.0,ACTUAL,UNC Lineberger Comprehensive Cancer Center,,1.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,OTHER,,,,,,,2023,1.0
NCT03376854,,2017-12-07,,,2021-04-27,2017-12-18,2017-12-19,ACTUAL,,,,,,,2021-04-27,2021-04-30,ACTUAL,2018-05-01,ACTUAL,2018-05-01,2021-04,2021-04-30,2021-04-27,ACTUAL,2021-04-27,2021-04-27,ESTIMATED,2021-04-27,,INTERVENTIONAL,CHILL-pilot,,Pilot RCT of Therapeutic Hypothermia Plus Neuromuscular Blockade in COVID-19 Patients With ARDS,Pilot Randomized Clinical Trial of Therapeutic Hypothermia Plus Neuromuscular Blockade vs. Standard of Care in COVID-19 Patients With Moderate to Severe ARDS - the Cooling to Help Injured Lungs (CHILL) Pilot Study,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of Maryland, Baltimore",,2.0,,Competition from other studies and initiation of a larger multi center trial,f,,,,t,t,t,,,f,,,All information will be available within one year of the publication of the main trial data.,Access will either be by email to Dr. Hasday or through a website to be developed.,,YES,"At the completion of the study, Dr. Hasday and colleagues will present the results of the long-term outcomes at national meetings and publish them in peer-reviewed journals and in ClinicalTrials.gov. Within one year of the publication of the main trial data (whichever occurs first, Dr. Hasday will make de-identified study data available to any individual who presents an appropriate question and analysis plan. The available information will include 1) descriptive documents (e.g. study protocol, code book/variable dictionary, data collection instruments, and de-identification methodology), and 2) de-identified data file.",2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,OTHER,,,,,,,2021,0.0
NCT05673109,,2022-12-19,,,2024-01-23,2023-01-04,2023-01-06,ACTUAL,,,,,,,2024-01-23,2024-01-25,ACTUAL,2023-02-22,ACTUAL,2023-02-22,2024-01,2024-01-31,2023-10-08,ACTUAL,2023-10-08,2023-10-08,ACTUAL,2023-10-08,,INTERVENTIONAL,,,A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer,"A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of AC176 in Chinese Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)",TERMINATED,,PHASE1,8.0,ACTUAL,Accutar Biotechnology Inc,,1.0,,"Subject benefit-risk ratio changes, sponsor decides to voluntarily terminate study",f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 19:27:40.32804,2024-10-15 19:27:40.32804,INDUSTRY,,,,,,,2023,0.0
NCT03204305,,2017-05-30,2022-12-16,,2023-03-20,2017-06-28,2017-07-02,ACTUAL,2023-03-20,2023-03-21,ACTUAL,,,,2023-03-20,2023-03-21,ACTUAL,2017-09-14,ACTUAL,2017-09-14,2023-03,2023-03-31,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,"There were 21 female cannabis users and 7 female healthy control nonusers enrolled. Of these, 10 of the female cannabis users and 2 healthy control female nonusers completed the full protocol and were included in the analysis. Due to low recruitment for healthy controls, 8 historical female healthy controls were included in analysis. We also conducted an analysis that compared all female controls (n=10; 2 healthy controls and 8 matched historical controls) with male historical controls.",Brain Imaging of Cannabinoid Receptors,Brain Imaging of Cannabinoid Receptors in Women,COMPLETED,,EARLY_PHASE1,28.0,ACTUAL,Johns Hopkins University,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,OTHER,,,,,,,2020,1.0
NCT04160468,,2019-11-07,2023-09-23,,2023-10-17,2019-11-08,2019-11-13,ACTUAL,2023-09-23,2023-10-18,ACTUAL,,,,2023-10-17,2023-11-02,ACTUAL,2019-12-20,ACTUAL,2019-12-20,2023-10,2023-10-31,2022-09-09,ACTUAL,2022-09-09,2022-09-09,ACTUAL,2022-09-09,,INTERVENTIONAL,DISRUPT,Microbiological intent-to-treat (mITT) analysis set,Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase,"A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Single Dose of Exebacase in Patients Receiving Standard-of-Care Antibiotics for the Treatment of Staphylococcus Aureus Bloodstream Infections (Bacteremia), Including Right-Sided Infective Endocarditis",TERMINATED,,PHASE3,259.0,ACTUAL,ContraFect,,2.0,,The independent DSMB recommended that the study be stopped for futility following interim efficacy analysis.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 07:16:26.799004,2024-10-16 07:16:26.799004,INDUSTRY,,,,,,,2022,0.0
NCT03022565,,2016-12-21,,,2020-02-04,2017-01-11,2017-01-16,ESTIMATED,,,,,,,2020-02-04,2020-02-06,ACTUAL,2020-01,ESTIMATED,2020-01-31,2020-02,2020-02-29,2020-01-29,ACTUAL,2020-01-29,2020-01-29,ACTUAL,2020-01-29,,INTERVENTIONAL,,,Vorinostat in Patients With Class 2 High Risk Uveal Melanoma,"Proof of Concept Study of Vorinostat, A Histone Deacetylase Inhibitor, in Patients With Class 2 High Risk Uveal Melanoma",WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Miami,,1.0,,Investigator Decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,OTHER,,,,,,,2020,0.0
NCT04057014,,2019-08-12,,,2020-10-02,2019-08-13,2019-08-14,ACTUAL,,,,,,,2020-10-02,2020-10-06,ACTUAL,2020-10,ESTIMATED,2020-10-31,2020-10,2020-10-31,2020-10-02,ACTUAL,2020-10-02,2020-10-02,ACTUAL,2020-10-02,,INTERVENTIONAL,,,Immediate Versus Delayed Treatment of Odontogenic Infections,A Prospective Study of Immediate Versus Delayed Treatment of Odontogenic Infections,WITHDRAWN,,PHASE4,0.0,ACTUAL,Boston Children's Hospital,,3.0,,No funding available for the activity,f,,,,f,t,f,,,t,,,,,,NO,There is no plan to share participant data.,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,OTHER,,,,,,,2020,0.0
NCT04565717,,2020-09-21,,,2024-05-16,2020-09-22,2020-09-25,ACTUAL,,,,,,,2024-05-16,2024-05-17,ACTUAL,2020-10-09,ACTUAL,2020-10-09,2024-05,2024-05-31,2023-12-21,ACTUAL,2023-12-21,2023-01-06,ACTUAL,2023-01-06,,INTERVENTIONAL,,,A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH),"A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 3-Part Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-HSD in Healthy Adult Subjects and Multiple Dose ALN-HSD in Adult Patients With Nonalcoholic Steatohepatitis (NASH)",TERMINATED,,PHASE1,6.0,ACTUAL,Alnylam Pharmaceuticals,,5.0,,Study ALN-HSD-001 was terminated due to business reasons and changes in the development strategy of the product. No safety issues were found.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 19:27:40.32804,2024-10-15 19:27:40.32804,INDUSTRY,,,,,,,2023,0.0
NCT02689024,,2016-02-09,,,2023-08-03,2016-02-18,2016-02-23,ESTIMATED,,,,,,,2023-08-03,2023-08-04,ACTUAL,2016-05,ACTUAL,2016-05-31,2023-08,2023-08-31,2023-07-19,ACTUAL,2023-07-19,2023-07-19,ACTUAL,2023-07-19,,INTERVENTIONAL,DEPTHip,,Delirium in Elderly Patients With Trauma of the Hip,A Multicenter Randomized Controlled Trial in Elderly Patients With Hip Fractures Comparing Continuous Fascia Iliaca Compartment Block to Systemic Opioids and Its Effect on Delirium Occurrence,TERMINATED,,PHASE4,239.0,ACTUAL,Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA),,2.0,,recruitment too slow; intervention was standard care in patients who were not included; acute care pathways changed due to policy regarding hip fracture patients,f,,,,t,,,,,,,,,,,YES,"After an embargo period data can be shared, depending on research question, objectives, statistics and methodology.",2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,OTHER,,,,,,,2023,0.0
NCT03973918,,2019-05-31,2023-10-20,,2024-02-07,2019-05-31,2019-06-04,ACTUAL,2024-02-07,2024-03-06,ACTUAL,,,,2024-02-07,2024-03-06,ACTUAL,2019-07-29,ACTUAL,2019-07-29,2024-02,2024-02-29,2023-10-01,ACTUAL,2023-10-01,2022-04-30,ACTUAL,2022-04-30,,INTERVENTIONAL,BRAF,"No patient were enrolled on the Surgical arm. this study was terminated early by a mandate from NCI to shut down the ABTC Consortium due to wanting a different strategy for Brain Tumor Research. As such,",Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG,A Phase II Study of Binimetinib in Combination With Encorafenib in Adults With Recurrent BRAF V600-Mutated High-Grade Astrocytoma or Other Primary Brain Tumor,TERMINATED,,PHASE2,5.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,"Due to early termination, results are given per cohort per patient, as the data is meaningless otherwise due to small numbers.~The NCI/CTEP mandated the closure of ABTC Consortium and hence why this study was terminated early",4.0,,NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,OTHER,,,,,,,2023,0.0
NCT01606098,,2012-05-23,,,2023-09-11,2012-05-24,2012-05-25,ESTIMATED,,,,,,,2023-09-11,2023-09-13,ACTUAL,2012-07,ACTUAL,2012-07-31,2023-09,2023-09-30,2022-12,ACTUAL,2022-12-31,2022-06,ACTUAL,2022-06-30,,INTERVENTIONAL,CAIRO4,,The Role of Surgery of the Primary Tumour in Patients With Synchronous Unresectable Metastases of Colorectal Cancer,"The Role of Surgery of the Primary Tumour With Few or Absent Symptoms in Patients With Synchronous Unresectable Metastases of Colorectal Cancer, a Randomized Phase III Study. A Study of the Dutch Colorectal Cancer Group (DCCG)",COMPLETED,,PHASE3,206.0,ACTUAL,Dutch Colorectal Cancer Group,,2.0,,,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-15 19:27:40.32804,2024-10-15 19:27:40.32804,OTHER,,,,,,,2022,0.0
NCT03787251,,2018-12-20,,,2022-04-11,2018-12-21,2018-12-26,ACTUAL,,,,,,,2022-04-11,2022-04-19,ACTUAL,2019-01-01,ESTIMATED,2019-01-01,2019-01,2019-01-31,2021-12-31,ESTIMATED,2021-12-31,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,A Study of Second-line Treatment of Postoperative Recurrence and Metastasis of Esophageal Cancer Treated With Apatinib,"Randomized, Open, Positive Drug Control, Multicenter Clinical Study of Second-line Treatment of Postoperative Recurrence and Metastasis of Esophageal Squamous Cell Carcinoma With Chemotherapy in Patients Treated With Apatinib Mesylate",WITHDRAWN,,PHASE2,0.0,ACTUAL,The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School,,2.0,,"In China, apatinib has been approved as an indication drug for esophageal squamous cell carcinoma, which makes it very difficult for our clinical trial to enroll patients. We regret that we failed to implement the design as planned.",f,,,,,f,f,,,,,,,,,,,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,OTHER,,,,,,,2021,0.0
NCT03654326,,2018-08-17,2021-06-15,,2021-06-15,2018-08-29,2018-08-31,ACTUAL,2021-06-15,2021-07-07,ACTUAL,,,,2021-06-15,2021-07-07,ACTUAL,2018-09-11,ACTUAL,2018-09-11,2021-06,2021-06-30,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034),"A Phase 2a, Proof of Concept, Randomized, Double-Blind, Placebo-Controlled Clinical Trial, to Evaluate the Efficacy and Safety of MK-7264 in Women With Moderate to Severe Endometriosis-Related Pain",COMPLETED,,PHASE2,187.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 19:27:40.32804,2024-10-15 19:27:40.32804,INDUSTRY,,,,,,,2020,1.0
NCT04853927,,2021-04-17,,,2022-02-17,2021-04-17,2021-04-22,ACTUAL,,,,,,,2022-02-17,2022-03-04,ACTUAL,2021-02-08,ACTUAL,2021-02-08,2021-02,2021-02-28,2021-12-31,ESTIMATED,2021-12-31,2021-10-30,ESTIMATED,2021-10-30,,INTERVENTIONAL,,,Proxalutamide Treatment for COVID-19 Patients in Intensive Care Unit,Proxalutamide Treatment for COVID-19 Patients in Intensive Care Unit,WITHDRAWN,,PHASE3,0.0,ACTUAL,"Applied Biology, Inc.",,2.0,,Sponsor to focus on hospitalised patients,f,,,,f,f,f,,,,,,,,,,,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,INDUSTRY,,,,,,,2021,0.0
NCT05376839,,2022-05-13,,,2022-12-07,2022-05-13,2022-05-17,ACTUAL,,,,,,,2022-12-07,2022-12-08,ACTUAL,2022-07-06,ACTUAL,2022-07-06,2022-12,2022-12-31,2022-11-08,ACTUAL,2022-11-08,2022-11-08,ACTUAL,2022-11-08,,INTERVENTIONAL,,,"A Study to Assess Safety of Cedirogant and How Cedirogant Moves Through the Body in Adult Participants With Mild, Moderate and Severe Hepatic Impairment","A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of Multiple Doses of Cedirogant (ABBV-157) in Subjects With Mild, Moderate and Severe Hepatic Impairment",TERMINATED,,PHASE1,6.0,ACTUAL,AbbVie,,4.0,,Strategic considerations,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 19:27:40.32804,2024-10-15 19:27:40.32804,INDUSTRY,,,,,,,2022,0.0
NCT03739606,,2018-10-24,,,2020-12-15,2018-11-09,2018-11-14,ACTUAL,,,,,,,2020-12-15,2020-12-17,ACTUAL,2020-10-20,ACTUAL,2020-10-20,2020-12,2020-12-31,2020-10-20,ACTUAL,2020-10-20,2020-10-20,ACTUAL,2020-10-20,,INTERVENTIONAL,,,Flotetuzumab in Treating Patients With Recurrent or Refractory CD123 Positive Blood Cancer,A Phase 2 Study to Evaluate the Anti-Tumor Activity of Single Agent Flotetuzumab in Advanced CD123-Positive Hematological Malignancies,WITHDRAWN,,PHASE2,0.0,ACTUAL,City of Hope Medical Center,,1.0,,RSS recommendation,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 19:27:40.32804,2024-10-15 19:27:40.32804,OTHER,,,,,,,2020,0.0
NCT02959411,,2016-10-17,,,2020-07-23,2016-11-06,2016-11-09,ESTIMATED,,,,,,,2020-07-23,2020-07-27,ACTUAL,2016-10,,2016-10-31,2020-07,2020-07-31,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,Tolvaptan for Advanced or Refractory Heart Failure,Tolvaptan for the Management of Acute Decompensated Heart Failure in Patients With Advanced or Refractory Heart Failure,TERMINATED,,PHASE4,9.0,ACTUAL,University of Calgary,,2.0,,Low accrual rate,f,,,,f,,,,,,,,,,,NO,,2024-10-15 19:27:40.32804,2024-10-15 19:27:40.32804,OTHER,,,,,,,2020,0.0
NCT03300479,,2017-09-08,,,2021-11-02,2017-10-02,2017-10-03,ACTUAL,,,,,,,2021-11-02,2021-11-08,ACTUAL,2017-06-15,ACTUAL,2017-06-15,2021-11,2021-11-30,2021-05-14,ACTUAL,2021-05-14,2021-05-14,ACTUAL,2021-05-14,,INTERVENTIONAL,Clevidipine,,Clevidipine (Cleviprex®) Compared With Urapidil (Ebrantil®),Clevidipine (Cleviprex®) Compared With Urapidil (Ebrantil®) for Blood Pressure Reduction in Patients With Primary Intracerebral Hemorrhage: A Randomized Controlled Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Zurich,,2.0,,No patient enrolled. No study conduct due to lack of human resources.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,OTHER,,,,,,,2021,0.0
NCT03611985,,2018-07-06,,,2020-01-09,2018-07-26,2018-08-02,ACTUAL,,,,,,,2020-01-09,2020-01-13,ACTUAL,2020-03,ESTIMATED,2020-03-31,2020-01,2020-01-31,2023-03,ESTIMATED,2023-03-31,2023-03,ESTIMATED,2023-03-31,,INTERVENTIONAL,,,Phase I/IIa Study of Pharmacokinetics and Safety of Epidiferphane™ and Taxanes in Breast Cancer Patients,Study of Pharmacokinetics and Safety of Epidiferphane™ and Taxanes in Breast Cancer Patients,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Florida,,1.0,,institutional conflict of interest,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 19:27:40.32804,2024-10-15 19:27:40.32804,OTHER,,,,,,,2023,0.0
NCT04493359,,2020-07-29,,,2021-09-28,2020-07-29,2020-07-30,ACTUAL,,,,,,,2021-09-28,2021-10-06,ACTUAL,2020-07-25,ACTUAL,2020-07-25,2021-09,2021-09-30,2021-09-28,ACTUAL,2021-09-28,2021-09-28,ACTUAL,2021-09-28,,INTERVENTIONAL,SWITCH-COVID,,Switch of Renin-Angiotensin System Inhibitors in Patients With Covid-19,Switch or Maintenance of Renin-Angiotensin System Inhibitors in Patients With Covid-19: A Randomized Proof of Concept Trial,TERMINATED,,PHASE2/PHASE3,18.0,ACTUAL,University of Sao Paulo,,2.0,,Dificulteis in enrolling patients,f,,,,t,f,f,,,f,,,,,,UNDECIDED,Data may be requested for collaboration projects,2024-10-15 19:27:40.32804,2024-10-15 19:27:40.32804,OTHER,,,,,,,2021,0.0
NCT03875729,,2019-03-13,2024-02-08,,2024-03-27,2019-03-13,2019-03-15,ACTUAL,2024-03-27,2024-04-24,ACTUAL,,,,2024-03-27,2024-04-24,ACTUAL,2019-04-05,ACTUAL,2019-04-05,2023-08,2023-08-31,2023-05-01,ACTUAL,2023-05-01,2023-05-01,ACTUAL,2023-05-01,,INTERVENTIONAL,PROTECT,Intent-to-treat population,Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab,"Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized Fc Receptor (FcR) Non-Binding Anti-cluster of Differentiation 3 (CD3) Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes",COMPLETED,,PHASE3,328.0,ACTUAL,"Provention Bio, Inc.",Enrollment into the study was temporarily suspended due to COronaVIrus Disease of 2019 (COVID-19) pandemic restrictions. Participants who were unable to receive the second 12-day treatment course at 6 months due to COVID-19 pandemic restrictions were given the second course at approximately 12 months (modified dosing schedule).,2.0,,,f,,,,t,t,f,,,,,,After drug approval,Qualified researchers,http://Vivli.org,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient levels data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.",2024-10-15 19:27:40.32804,2024-10-15 19:27:40.32804,INDUSTRY,,,,,,,2023,1.0
NCT04749797,,2021-01-11,2022-10-28,,2023-08-29,2021-02-08,2021-02-11,ACTUAL,2023-08-29,2023-09-13,ACTUAL,,,,2023-08-29,2023-09-13,ACTUAL,2020-09-02,ACTUAL,2020-09-02,2023-08,2023-08-31,2021-07-20,ACTUAL,2021-07-20,2021-07-20,ACTUAL,2021-07-20,,INTERVENTIONAL,,,Cranial Blocks for Postoperative Anesthesia,Randomized Study Of Cranial Blocks For Postoperative Anesthesia To Reduce Pain And Postoperative Opioid Usage,TERMINATED,,PHASE4,11.0,ACTUAL,University of Pennsylvania,Study concluded before reaching subject n goal due to slow enrollment related to COVID-19 pandemic and PI leaving institution. Sample size not significant enough to accurately analyze data.,3.0,,PI left institution,f,,,,,t,f,,,t,,,,,,UNDECIDED,No plan at this time to share data with other researchers.,2024-10-15 19:27:40.32804,2024-10-15 19:27:40.32804,OTHER,,,,,,,2021,0.0
NCT02743806,,2016-04-15,2023-11-01,,2023-11-01,2016-04-15,2016-04-19,ESTIMATED,2023-11-01,2023-11-18,ACTUAL,,,,2023-11-01,2023-11-18,ACTUAL,2016-08-01,ACTUAL,2016-08-01,2023-11,2023-11-30,2023-01-03,ACTUAL,2023-01-03,2023-01-03,ACTUAL,2023-01-03,,INTERVENTIONAL,,"Full Analysis Set (FAS) consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).",Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease,Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease,TERMINATED,,PHASE4,331.0,ACTUAL,Takeda,,1.0,,Early Completed - Alternative Source of Drug Available,f,,,,f,t,f,,,t,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,INDUSTRY,,,,,,,2023,0.0
NCT04618393,,2020-10-18,,,2024-05-17,2020-11-04,2020-11-05,ACTUAL,,,,,,,2024-05-17,2024-05-21,ACTUAL,2021-03-11,ACTUAL,2021-03-11,2024-05,2024-05-31,2024-03-21,ACTUAL,2024-03-21,2023-07-12,ACTUAL,2023-07-12,,INTERVENTIONAL,,,A Study of EMB-02 in Participants With Advanced Solid Tumors,"A Phase I/II Trial of EMB-02, a Bi-specific Antibody Against PD-1 and LAG-3, in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,47.0,ACTUAL,"Shanghai EpimAb Biotherapeutics Co., Ltd.",,1.0,,Company's resource optimization and product's development change,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 07:16:26.799004,2024-10-16 07:16:26.799004,INDUSTRY,,,,,,,2024,0.0
NCT05612633,,2021-10-04,,,2022-11-04,2022-11-04,2022-11-10,ACTUAL,,,,,,,2022-11-04,2022-11-10,ACTUAL,2022-06-15,ESTIMATED,2022-06-15,2022-11,2022-11-30,2024-02-23,ESTIMATED,2024-02-23,2023-12-15,ESTIMATED,2023-12-15,,INTERVENTIONAL,AP-MPN,,A Study of Zelavespib (PU-H71) in Subjects With AP-MPN or BP-MPN,A Phase 2 Open-label Study of Zelavespib (PU-H71) in Subjects With Accelerated Phase Myeloproliferative Neoplasm (AP MPN) or Blast Phase Myeloproliferative Neoplasm,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Samus Therapeutics, Inc.",,1.0,,Samus Therapeutics Closure,,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,INDUSTRY,,,,,,,2024,0.0
NCT03836885,,2019-02-08,,,2020-06-23,2019-02-08,2019-02-11,ACTUAL,,,,,,,2020-06-23,2020-06-25,ACTUAL,2019-11-21,ACTUAL,2019-11-21,2020-06,2020-06-30,2020-04-22,ACTUAL,2020-04-22,2020-04-22,ACTUAL,2020-04-22,,INTERVENTIONAL,APOLP,,Apremilast - Oral Lichen Planus Trial,"The APOLP Trial: A Single-Center, Randomized, 16 Weeks, Explanatory, Parallel-Group, Superiority, Blinded, Placebo-Controlled, Clinical Trial of Apremilast Use in Oral Lichen Planus",WITHDRAWN,,PHASE2,0.0,ACTUAL,Sunnybrook Health Sciences Centre,,2.0,,Study was terminated due to delay in enrollment.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 19:27:40.32804,2024-10-15 19:27:40.32804,OTHER,,,,,,,2020,0.0
NCT02684032,,2016-02-10,,,2022-07-25,2016-02-11,2016-02-17,ESTIMATED,,,,,,,2022-07-25,2022-07-27,ACTUAL,2016-06-14,ACTUAL,2016-06-14,2022-07,2022-07-31,2022-01-19,ACTUAL,2022-01-19,2022-01-19,ACTUAL,2022-01-19,,INTERVENTIONAL,,,A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer,"PHASE 1B STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND CLINICAL ACTIVITY OF GEDATOLISIB IN COMBINATION WITH PALBOCICLIB AND EITHER LETROZOLE OR FULVESTRANT IN WOMEN WITH METASTATIC OR LOCALLY ADVANCED/RECURRENT BREAST CANCER (MBC)",COMPLETED,,PHASE1,141.0,ACTUAL,Celcuity Inc,,6.0,,,f,,,,f,,,,,,,,,,,NO,"Celcuity will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.",2024-10-15 19:27:40.32804,2024-10-15 19:27:40.32804,INDUSTRY,,,,,,,2022,1.0
NCT02065869,,2014-02-13,2022-10-04,2020-11-11,2023-09-22,2014-02-17,2014-02-19,ESTIMATED,2022-12-12,2023-01-04,ACTUAL,2020-11-13,2020-11-17,ACTUAL,2023-09-22,2023-09-29,ACTUAL,2014-04,ACTUAL,2014-04-30,2023-09,2023-09-30,2021-09-07,ACTUAL,2021-09-07,2020-06,ACTUAL,2020-06-30,,INTERVENTIONAL,,All enrolled patients iwho received HSCT (HSCT safety population),Safety Study of Gene Modified Donor T-cells Following TCRαβ+ Depleted Stem Cell Transplant,Phase I/II Study of CaspaCIDe T Cells (BPX-501; Rivogenlecleucel) From an HLA Partially Matched Family Donor After Negative Selection of TCRαβ+ T Cells in Paediatric Patients Affected by Haematological Disorders,TERMINATED,,PHASE1/PHASE2,187.0,ACTUAL,Bellicum Pharmaceuticals,,1.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 07:16:26.799004,2024-10-16 07:16:26.799004,INDUSTRY,,,,,,,2021,0.0
NCT04108858,,2019-09-27,2024-01-11,,2024-06-18,2019-09-27,2019-09-30,ACTUAL,2024-06-18,2024-06-27,ACTUAL,,,,2024-06-18,2024-06-27,ACTUAL,2021-05-20,ACTUAL,2021-05-20,2024-06,2024-06-30,2022-04-29,ACTUAL,2022-04-29,2022-04-29,ACTUAL,2022-04-29,,INTERVENTIONAL,,"This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.","Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer",Phase Ib/II Trial of Copanlisib in Combination With Trastuzumab and Pertuzumab After Induction Treatment of HER2 Positive (HER2+) Metastatic Breast Cancer (MBC) With PIK3CA Mutation or PTEN Mutation,TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,National Cancer Institute (NCI),,2.0,,Inadequate accrual rate,f,,,,f,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.",2024-10-15 19:27:40.32804,2024-10-15 19:27:40.32804,NIH,,,,,,,2022,0.0
NCT03711279,,2018-10-16,2023-07-13,,2024-02-27,2018-10-16,2018-10-18,ACTUAL,2024-02-27,2024-02-29,ACTUAL,,,,2024-02-27,2024-02-29,ACTUAL,2018-11-22,ACTUAL,2018-11-22,2023-07,2023-07-31,2021-06-21,ACTUAL,2021-06-21,2021-06-21,ACTUAL,2021-06-21,,INTERVENTIONAL,,,A Study of SHR-1210 Plus Apatinib in Patients With Soft Tissue Sarcoma,"A Multicenter, Randomized, Open, Phase 2 Trial of SHR-1210 Plus Apatinib Versus Doxorubicin (ADM) Plus Ifosfamide (IFO) in Patients With Soft Tissue Sarcoma",TERMINATED,,PHASE2,99.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,2.0,,Sponsor R \& D Strategy Adjustment,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,INDUSTRY,,,,,,,2021,0.0
NCT02818894,,2016-06-28,2022-08-25,2022-01-11,2022-08-25,2016-06-28,2016-06-30,ESTIMATED,2022-08-25,2022-09-23,ACTUAL,2022-01-11,2022-01-13,ACTUAL,2022-08-25,2022-09-23,ACTUAL,2016-09-27,ACTUAL,2016-09-27,2022-08,2022-08-31,2020-03-05,ACTUAL,2020-03-05,2020-03-05,ACTUAL,2020-03-05,,INTERVENTIONAL,,,Spinal Anesthesia in Total Hip Arthroplasty,"Comparison of Lidocaine Versus Bupivacaine Spinal Anesthesia in Total Hip Arthroplasty: A Randomized, Double-Blind, Prospective Study",TERMINATED,,PHASE4,135.0,ACTUAL,Emory University,The study was terminated due to extended suspension of the study related to personnel issues and pandemic-related issues. Missing data due to lost study records limited the number of available data points.,2.0,,"This study was terminated due to pressing matters related to the COVID-19 pandemic - staff shortages and changes of personnel, data gaps due to the pandemic, participants not being able to continue follow-up visits, and ongoing enrollment issues.",f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,OTHER,,,,,,,2020,0.0
NCT04604652,,2020-10-16,2023-09-07,,2024-03-27,2020-10-21,2020-10-27,ACTUAL,2024-03-27,2024-04-24,ACTUAL,,,,2024-03-27,2024-04-24,ACTUAL,2021-05-27,ACTUAL,2021-05-27,2023-09,2023-09-30,2022-05-31,ACTUAL,2022-05-31,2022-05-31,ACTUAL,2022-05-31,,INTERVENTIONAL,PRONTO-PBC,,Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis,"A Phase 2 Open Label, Proof of Concept Study of HTD1801 (BUDCA) in Adult Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to Standard Therapy - PRONTO-PBC",COMPLETED,,PHASE2,24.0,ACTUAL,HighTide Biopharma Pty Ltd,"This was a small, open-label, proof of concept study with no control group where subjects discontinued UDCA at Baseline. Limitations of the study include potentially being underpowered for the primary endpoint and the safety included adverse events from the 4-week follow-up period after treatment discontinuation. Additional placebo-controlled studies are needed to further evaluate the benefit of HTD1801 in PBC.",1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,INDUSTRY,,,,,,,2022,1.0
NCT04176952,,2019-10-28,,,2022-05-17,2019-11-21,2019-11-26,ACTUAL,,,,,,,2022-05-17,2022-05-24,ACTUAL,2019-03-05,ACTUAL,2019-03-05,2022-05,2022-05-31,2021-08-19,ACTUAL,2021-08-19,2021-08-19,ACTUAL,2021-08-19,,INTERVENTIONAL,PRIMUS002,,PRIMUS002: Looking at 2 Neo-adjuvant Treatment Regimens for Resectable and Borderline Resectable Pancreatic Cancer,"PRIMUS002: An Umbrella Phase II Study Examining Two Neo-adjuvant Regimens (FOLFOX-A and AG) in Resectable and Borderline Resectable Pancreatic Ductal AdenoCarcinoma (PDAC), Focusing on Biomarker and Liquid Biopsy Development",TERMINATED,,PHASE2,31.0,ACTUAL,University of Glasgow,,2.0,,Due to funding being withdrawn,f,,,,t,f,f,,,,,,Once clinical study report has been written and primary publication accepted by peer reviewed journal,On request to trial management group,,YES,Clinical data will be made available on request once clinical study report has been written and primary publication accepted by peer reviewed journal,2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,OTHER,,,,,,,2021,0.0
NCT03052517,,2017-01-23,2020-09-14,,2020-09-14,2017-02-09,2017-02-14,ACTUAL,2020-09-14,2020-10-12,ACTUAL,,,,2020-09-14,2020-10-12,ACTUAL,2017-03-21,ACTUAL,2017-03-21,2020-09,2020-09-30,2020-03-16,ACTUAL,2020-03-16,2020-02-19,ACTUAL,2020-02-19,,INTERVENTIONAL,,SAF: All patients who received at least one dose of study drug during this study.,Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment,"A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.",TERMINATED,,PHASE3,2538.0,ACTUAL,Novartis,,3.0,,Company Decision,f,,,,,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,INDUSTRY,,,,,,,2020,0.0
NCT03888807,,2018-07-02,,,2024-07-31,2019-03-22,2019-03-25,ACTUAL,,,,,,,2024-07-31,2024-08-02,ACTUAL,2018-03-01,ACTUAL,2018-03-01,2024-07,2024-07-31,2024-07-31,ACTUAL,2024-07-31,2024-07-31,ACTUAL,2024-07-31,,INTERVENTIONAL,,,Biofreeze® vs. a Placebo on Knee Osteoarthritis Walking Gait Characteristics and Pain,The Effect of Biofreeze® vs. a Placebo on Knee Osteoarthritis Walking Gait Characteristics and Pain,TERMINATED,,PHASE4,6.0,ACTUAL,Sport and Spine Rehab Clinical Research Foundation,,2.0,,Decided not go move forward with this population as recruitment was difficult,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,OTHER,,,,,,,2024,0.0
NCT02022293,,2013-12-11,,,2017-12-01,2013-12-20,2013-12-27,ESTIMATED,,,,,,,2017-12-01,2017-12-04,ACTUAL,2017-01,ACTUAL,2017-01-31,2017-12,2017-12-31,2024-01,ESTIMATED,2024-01-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis,"Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis: A Multicenter, Double-blind, Placebo-Controlled, Randomized Trial",SUSPENDED,,PHASE2,324.0,ESTIMATED,Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University,,2.0,,Enrollment target could not be achieved.,f,,,,t,,,,,,,,,,,,,2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,OTHER,,,,,,,2024,0.0
NCT04309656,,2020-01-23,2023-09-27,,2024-07-22,2020-03-13,2020-03-16,ACTUAL,2024-07-22,2024-07-24,ACTUAL,,,,2024-07-22,2024-07-24,ACTUAL,2020-01-14,ACTUAL,2020-01-14,2024-07,2024-07-31,2020-02-28,ACTUAL,2020-02-28,2020-02-28,ACTUAL,2020-02-28,,INTERVENTIONAL,,,Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid,"An Open-label, Randomized, Four-period, Crossover Study in Two Panels of Healthy Adult Subjects to Assess the Relative Bioavailability, Food Effect, and Dose-dependence of Single-dose Immediate-release and Single-dose Dispersible Formulations of Pretomanid",COMPLETED,,PHASE1,48.0,ACTUAL,Global Alliance for TB Drug Development,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,OTHER,,,,,,,2020,1.0
NCT03622580,,2018-08-01,2022-02-23,2021-09-01,2022-08-22,2018-08-07,2018-08-09,ACTUAL,2022-02-23,2022-03-22,ACTUAL,2021-09-01,2021-09-09,ACTUAL,2022-08-22,2022-09-16,ACTUAL,2018-09-05,ACTUAL,2018-09-05,2022-08,2022-08-31,2021-09-03,ACTUAL,2021-09-03,2020-10-20,ACTUAL,2020-10-20,,INTERVENTIONAL,,"The overall number of baseline participants (940) comprises the Intent-to-Treat (ITT) Population, which includes all global participants who were randomized in the study, grouped according to the treatment assigned at randomization.",A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE),"A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE)",COMPLETED,,PHASE3,940.0,ACTUAL,Hoffmann-La Roche,"All secondary outcome measures were unpowered for statistical analysis, and the results should be interpreted with caution.",3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,INDUSTRY,,,,,,,2021,1.0
NCT01363128,,2011-05-27,2021-04-06,,2021-04-06,2011-05-27,2011-06-01,ESTIMATED,2021-04-06,2021-05-03,ACTUAL,,,,2021-04-06,2021-05-03,ACTUAL,2011-07-12,ACTUAL,2011-07-12,2021-04,2021-04-30,2020-04-08,ACTUAL,2020-04-08,2020-04-08,ACTUAL,2020-04-08,,INTERVENTIONAL,,,Combination Chemotherapy and Ofatumumab in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma,Phase II Study of the Hyper - CVAD Regimen in Combination With Ofatumumab as Frontline Therapy for Patients With CD-20 Positive Acute Lymphoblastic Leukemia,COMPLETED,,PHASE2,72.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,OTHER,,,,,,,2020,1.0
NCT04588207,,2020-10-07,2024-02-27,,2024-04-23,2020-10-07,2020-10-19,ACTUAL,2024-04-23,2024-05-20,ACTUAL,,,,2024-04-23,2024-05-20,ACTUAL,2021-12-28,ACTUAL,2021-12-28,2024-04,2024-04-30,2022-09-29,ACTUAL,2022-09-29,2022-09-29,ACTUAL,2022-09-29,,INTERVENTIONAL,,,Urea for Chronic Hyponatremia,Urea for Chronic Hyponatremia: A Pilot Study,TERMINATED,,PHASE2,2.0,ACTUAL,University of Pittsburgh,Study was terminated because of inability to recruit. Only two participants were recruited of the estimated 30 participants.,2.0,,Unable to recruit participants,,,,,t,t,f,,,,,,12 months after publication of primary manuscript,Request in writing addressed to the principal investigator,,YES,The investigators will share all collected IPD,2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,OTHER,,,,,,,2022,0.0
NCT05702788,,2023-01-18,,,2024-04-25,2023-01-26,2023-01-27,ACTUAL,,,,,,,2024-04-25,2024-04-26,ACTUAL,2022-09,ESTIMATED,2022-09-30,2024-04,2024-04-30,2024-04-23,ACTUAL,2024-04-23,2024-04-23,ACTUAL,2024-04-23,,INTERVENTIONAL,COVID-19,,Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19),"A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Study to Evaluate the Efficacy and Safety of Jaktinib Hydrochloride Tablets in Participants Receiving the Best Available Treatment for Severe Novel Coronavirus Pneumonia",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Suzhou Zelgen Biopharmaceuticals Co.,Ltd",,3.0,,Sponsor R\&D Strategy Adjustment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,INDUSTRY,,,,,,,2024,0.0
NCT04186377,,2019-12-02,,,2022-06-06,2019-12-02,2019-12-04,ACTUAL,,,,,,,2022-06-06,2022-06-08,ACTUAL,2020-05-15,ACTUAL,2020-05-15,2022-06,2022-06-30,2021-11-29,ACTUAL,2021-11-29,2021-11-29,ACTUAL,2021-11-29,,INTERVENTIONAL,,,Application of S26E for Diabetic Foot Ulcer Healing,A Study of the Effectiveness of Local S26E Extract Application for Diabetic Foot Ulcer Healing,TERMINATED,,PHASE2,5.0,ACTUAL,National and Kapodistrian University of Athens,,2.0,,Inability to recruit subjects,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,OTHER,,,,,,,2021,0.0
NCT04363437,,2020-04-23,2022-01-28,,2022-02-16,2020-04-23,2020-04-27,ACTUAL,2022-02-16,2022-02-18,ACTUAL,,,,2022-02-16,2022-02-18,ACTUAL,2020-04-26,ACTUAL,2020-04-26,2022-01,2022-01-31,2020-07-31,ACTUAL,2020-07-31,2020-07-31,ACTUAL,2020-07-31,,INTERVENTIONAL,COMBATCOVID19,,COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19,COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19 (the COMBAT-COVID-19 Pilot Study),TERMINATED,,PHASE2,21.0,ACTUAL,Maimonides Medical Center,,2.0,,"Stopped due to widespread corticosteroid use in 2020 for COVID infection, which confounds and likely supercedes the effect of colchicine.",f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,OTHER,,,,,,,2020,0.0
NCT02432066,,2015-04-28,,,2019-03-21,2015-04-28,2015-05-01,ESTIMATED,,,,,,,2019-03-21,2019-03-25,ACTUAL,2018-09-29,ESTIMATED,2018-09-29,2019-03,2019-03-31,2020-12-29,ESTIMATED,2020-12-29,2018-12-29,ESTIMATED,2018-12-29,,INTERVENTIONAL,,,Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions,Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Florida,,2.0,,Study was not started and participants were not enrolled,f,,,,f,t,f,,,,,,,,,,,2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,OTHER,,,,,,,2020,0.0
NCT04789330,,2021-03-04,,,2022-05-03,2021-03-08,2021-03-09,ACTUAL,,,,,,,2022-05-03,2022-05-05,ACTUAL,2021-07-01,ACTUAL,2021-07-01,2022-05,2022-05-31,2022-04-01,ACTUAL,2022-04-01,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,VEGA-1,,Norepinephrine vs Phenylephrine During General Anesthesia,The Choice of Vasopressor for Treating Hypotension During General Anesthesia: a Pilot Pragmatic Cluster Cross-over Randomized Trial (the VEGA-1 Trial),COMPLETED,,PHASE4,2000.0,ACTUAL,"University of California, San Francisco",,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,OTHER,,,,,,,2022,0.0
NCT03566823,,2018-05-09,2021-04-16,,2021-04-16,2018-06-21,2018-06-25,ACTUAL,2021-04-16,2021-05-11,ACTUAL,,,,2021-04-16,2021-05-11,ACTUAL,2018-07-17,ACTUAL,2018-07-17,2021-04,2021-04-30,2020-08-18,ACTUAL,2020-08-18,2020-08-18,ACTUAL,2020-08-18,,INTERVENTIONAL,CARMEN CD 306,The safety set consisted of all participants who had received at least 1 dose of investigational product (IP).,Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306),"A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 306)",TERMINATED,,PHASE3,34.0,ACTUAL,Takeda,The study was terminated as the sponsor discontinued the ontamalimab clinical trial program in ulcerative colitis and CD for reasons unrelated to safety.,3.0,,Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,INDUSTRY,,,,,,,2020,0.0
NCT04571580,,2020-09-19,,,2023-09-13,2020-09-26,2020-10-01,ACTUAL,,,,,,,2023-09-13,2023-09-14,ACTUAL,2021-07-01,ACTUAL,2021-07-01,2023-09,2023-09-30,2023-01-31,ACTUAL,2023-01-31,2023-01-31,ACTUAL,2023-01-31,,INTERVENTIONAL,RECOVERII,,Effect of Low-dose Intracoronary Reteplase on Myocardial Infarct Size During Primary Percutaneous Coronary Intervention,Effect of Low-dose Intracoronary Reteplase During Primary Percutaneous Coronary Intervention on Myocardial Infarct Size in Patients With Acute Myocardial Infarction,TERMINATED,,PHASE3,36.0,ACTUAL,Fudan University,,3.0,,The study enrollment is slow due to the pandemic.,f,,,,,f,f,,,,,,,,,,,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,OTHER,,,,,,,2023,0.0
NCT03724409,,2018-10-25,,,2023-11-24,2018-10-26,2018-10-30,ACTUAL,,,,,,,2023-11-24,2023-11-28,ACTUAL,2018-10-11,ACTUAL,2018-10-11,2023-11,2023-11-30,2023-05-23,ACTUAL,2023-05-23,2021-03-21,ACTUAL,2021-03-21,,INTERVENTIONAL,,,Selective Intra-arterial Injection of PRRT in Neuroendocrine Tumor Patients With Liver Metastases,Selective Intra-arterial Injection of Peptide Receptor Radionuclide Therapy (PRRT) in Neuroendocrine Tumor Patients With Liver Metastases,TERMINATED,,EARLY_PHASE1,3.0,ACTUAL,University of Iowa,,6.0,,Pandemic,f,,,,t,t,f,,,,,,Considered upon request.,Contact study PI regarding data sharing. A non-disclosure agreement may be required between institutions dependent upon the data requested.,,YES,Data will be shared as per approved IRB application and the subject's opt-in preferences. Data will not be provided from subjects who decline data sharing.,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,OTHER,,,,,,,2023,0.0
NCT04592419,,2020-10-12,2024-04-04,,2024-06-14,2020-10-16,2020-10-19,ACTUAL,2024-05-09,2024-06-06,ACTUAL,,,,2024-06-14,2024-06-26,ACTUAL,2020-09-25,ACTUAL,2020-09-25,2024-06,2024-06-30,2023-01-19,ACTUAL,2023-01-19,2022-06-10,ACTUAL,2022-06-10,,INTERVENTIONAL,BEACON,Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit.,"A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)","A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion (RVO)",COMPLETED,,PHASE3,568.0,ACTUAL,Kodiak Sciences Inc,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,INDUSTRY,,,,,,,2023,1.0
NCT03031782,,2016-11-02,2021-05-06,2020-05-19,2022-08-12,2017-01-23,2017-01-26,ESTIMATED,2022-08-12,2022-08-15,ACTUAL,2022-08-12,2022-08-15,ACTUAL,2022-08-12,2022-08-15,ACTUAL,2017-05-23,ACTUAL,2017-05-23,2022-08,2022-08-31,2020-11-09,ACTUAL,2020-11-09,2020-10-07,ACTUAL,2020-10-07,,INTERVENTIONAL,,"Safety Set included subjects who received any treatment. TP1 = 86, TP2 = 75",Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA),"A Three-part Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Secukinumab Treatment in Juvenile Idiopathic Arthritis Subtypes of Psoriatic and Enthesitis-related Arthritis",COMPLETED,,PHASE3,86.0,ACTUAL,Novartis,,2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,INDUSTRY,,,,,,,2020,1.0
NCT04912856,,2021-05-03,,,2023-12-18,2021-05-27,2021-06-03,ACTUAL,,,,,,,2023-12-18,2023-12-26,ACTUAL,2021-08-17,ACTUAL,2021-08-17,2023-12,2023-12-31,2023-11-17,ACTUAL,2023-11-17,2023-11-17,ACTUAL,2023-11-17,,INTERVENTIONAL,EPIK-OLE,,An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE,An Open-Label Extension of the Study XEN496 in Children With KCNQ2 Developmental and Epileptic Encephalopathy,TERMINATED,,PHASE3,8.0,ACTUAL,Xenon Pharmaceuticals Inc.,,2.0,,Sponsor decision; not a safety decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,INDUSTRY,,,,,,,2023,0.0
NCT03971734,,2019-05-31,,,2023-10-04,2019-05-31,2019-06-03,ACTUAL,,,,,,,2023-10-04,2023-10-06,ACTUAL,2019-12-06,ACTUAL,2019-12-06,2023-10,2023-10-31,2023-10-02,ACTUAL,2023-10-02,2022-04-30,ACTUAL,2022-04-30,,INTERVENTIONAL,,,Determining Dose of Regadenoson Most Likely to Transiently Alter the Integrity of the Blood-Brain Barrier in Patients With High Grade Gliomas,Determining the Dose of Regadenoson Most Likely to Transiently Alter the Integrity of the Blood-Brain Barrier in Patients With High Grade Gliomas,TERMINATED,,PHASE1,7.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,7.0,,Terminated \[NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer\],f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,OTHER,,,,,,,2023,0.0
NCT05247307,,2022-02-17,,,2022-02-18,2022-02-17,2022-02-18,ACTUAL,,,,,,,2022-02-18,2022-03-07,ACTUAL,2020-03-31,ACTUAL,2020-03-31,2022-02,2022-02-28,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Efficacy of the Infusion of Donor Plasma in COVID-19 Infection,"Clinical Efficacy of the Infusion of Donor Plasma, Convalescent From SARS-CoV-2 Infection, to Patients With Recent Infection.",TERMINATED,,PHASE3,93.0,ACTUAL,Hospital Galdakao-Usansolo,,2.0,,Lack of efficacy of treatment tested,f,,,,t,f,f,,,,,,Around this year 2022,Contact with principal investigator,,YES,Upon request,2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,OTHER_GOV,,,,,,,2021,0.0
NCT03993639,,2019-05-23,,,2021-01-20,2019-06-19,2019-06-21,ACTUAL,,,,,,,2021-01-20,2021-01-22,ACTUAL,2019-05-28,ACTUAL,2019-05-28,2021-01,2021-01-31,2020-08-28,ACTUAL,2020-08-28,2020-07-21,ACTUAL,2020-07-21,,INTERVENTIONAL,,,KRN125 for Mobilization of Hematopoietic Stem Cells,A Phase II Clinical Trial of KRN125 to Mobilize Hematopoietic Stem Cells Into Peripheral Blood in Healthy Volunteers,COMPLETED,,PHASE2,35.0,ACTUAL,"Kyowa Kirin Co., Ltd.",,1.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,INDUSTRY,,,,,,,2020,1.0
NCT04891250,,2021-05-11,,,2022-01-19,2021-05-17,2021-05-18,ACTUAL,,,,,,,2022-01-19,2022-02-03,ACTUAL,2021-10,ESTIMATED,2021-10-31,2022-01,2022-01-31,2022-06,ESTIMATED,2022-06-30,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,ZIT,,The Zambia Ivermectin Trial for the Treatment and Prevention of COVID-19,The Zambia Ivermectin Trial for the Treatment and Prevention of COVID-19,WITHDRAWN,,PHASE4,0.0,ACTUAL,Centre for Infectious Disease Research in Zambia,,2.0,,Insufficient funding,f,,,,,f,f,,,f,,,,,,,,2024-10-16 07:16:26.799004,2024-10-16 07:16:26.799004,OTHER,,,,,,,2022,0.0
NCT03692871,,2018-09-28,2022-03-09,,2023-07-20,2018-09-28,2018-10-02,ACTUAL,2022-04-15,2022-05-10,ACTUAL,,,,2023-07-20,2023-07-28,ACTUAL,2018-12-14,ACTUAL,2018-12-14,2023-07,2023-07-31,2021-03-26,ACTUAL,2021-03-26,2021-03-26,ACTUAL,2021-03-26,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK),"A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)",COMPLETED,,PHASE3,2409.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,INDUSTRY,,,,,,,2021,1.0
NCT03626376,,2018-08-08,,,2021-12-29,2018-08-08,2018-08-13,ACTUAL,,,,,,,2021-12-29,2022-01-14,ACTUAL,2019-12-10,ACTUAL,2019-12-10,2021-12,2021-12-31,2022-03-02,ESTIMATED,2022-03-02,2021-03-02,ESTIMATED,2021-03-02,,INTERVENTIONAL,,,Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis,A Randomized Trial of Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis,WITHDRAWN,,PHASE4,0.0,ACTUAL,NYU Langone Health,,2.0,,Unable to enroll participants,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,OTHER,,,,,,,2022,0.0
NCT04693637,,2020-12-09,2023-12-19,,2024-05-07,2020-12-31,2021-01-05,ACTUAL,2024-04-11,2024-05-07,ACTUAL,,,,2024-05-07,2024-05-09,ACTUAL,2021-01-15,ACTUAL,2021-01-15,2024-05,2024-05-31,2023-01-19,ACTUAL,2023-01-19,2023-01-19,ACTUAL,2023-01-19,,INTERVENTIONAL,Prevent,Analysis Population will include all patients who received posoleucel.,"Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant","Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant",COMPLETED,,PHASE2/PHASE3,26.0,ACTUAL,AlloVir,,1.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 19:33:42.930318,2024-10-15 19:33:42.930318,INDUSTRY,,,,,,,2023,1.0
NCT05383560,,2022-05-15,,,2024-02-19,2022-05-19,2022-05-20,ACTUAL,,,,,,,2024-02-19,2024-02-21,ACTUAL,2022-09-05,ACTUAL,2022-09-05,2024-02,2024-02-29,2024-01-31,ACTUAL,2024-01-31,2024-01-31,ACTUAL,2024-01-31,,INTERVENTIONAL,SH-MO-214,,Safety and Immunogenicity of Omicron Variant-Matched Vaccine Booster in Adults,"Phase 2, Randomized, Observer-Blind, Investigator-Initiated, Collaborative Study to Evaluate the Safety and Immunogenicity of Omicron Variant-Matched Vaccine Booster in Adults",COMPLETED,,PHASE2,179.0,ACTUAL,Sheba Medical Center,,5.0,,,f,,,,t,f,f,,,,,,will be available upon publication of results,Upon request. Requires collaborator's approval as well.,,YES,Unidentified data will be available after publication of the results.,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,OTHER_GOV,,,,,,,2024,1.0
NCT04429503,,2020-05-26,2023-07-25,2023-05-19,2024-07-22,2020-06-10,2020-06-12,ACTUAL,2023-10-27,2023-11-21,ACTUAL,,2023-11-21,ACTUAL,2024-07-22,2024-07-30,ACTUAL,2020-06-29,ACTUAL,2020-06-29,2024-07,2024-07-31,2024-06-18,ACTUAL,2024-06-18,2022-05-30,ACTUAL,2022-05-30,,INTERVENTIONAL,PHOTON,Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized). Only one study eye per participant was analyzed within the study.,Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease,"A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema",COMPLETED,,PHASE2/PHASE3,660.0,ACTUAL,Regeneron Pharmaceuticals,,3.0,,,f,,,,t,t,f,,,,,,"Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.","Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in a manuscript. Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.",https://vivli.org/,YES,All IPD that underlie results in a publication.,2024-10-16 07:16:26.799004,2024-10-16 07:16:26.799004,INDUSTRY,,,,,,,2024,1.0
NCT02864251,,2016-08-09,2023-01-10,,2023-09-06,2016-08-09,2016-08-11,ESTIMATED,2023-01-10,2023-02-06,ACTUAL,,,,2023-09-06,2023-09-28,ACTUAL,2017-03-17,ACTUAL,2017-03-17,2023-09,2023-09-30,2022-10-17,ACTUAL,2022-10-17,2022-01-20,ACTUAL,2022-01-20,,INTERVENTIONAL,CheckMate722,,A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy,"Open-Label, Randomized Trial of Nivolumab (BMS-936558) Plus Pemetrexed/Platinum or Nivolumab Plus Ipilimumab (BMS-734016) vs Pemetrexed Plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor Therapy",COMPLETED,,PHASE3,367.0,ACTUAL,Bristol-Myers Squibb,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,INDUSTRY,,,,,,,2022,1.0
NCT04446377,,2020-06-23,2023-05-19,,2023-08-04,2020-06-23,2020-06-24,ACTUAL,2023-08-04,2023-08-08,ACTUAL,,,,2023-08-04,2023-08-08,ACTUAL,2020-07-15,ACTUAL,2020-07-15,2023-08,2023-08-31,2021-04-19,ACTUAL,2021-04-19,2021-03-24,ACTUAL,2021-03-24,,INTERVENTIONAL,,The intention-to-treat (ITT) population included all participants randomized according to their initial randomized assignment regardless of the treatment actually received.,A Study of LAM-002A for the Prevention of Progression of COVID-19,"A Phase II Randomized, Double-Blind, Placebo-Controlled Study of LAM-002A for the Prevention of Progression of COVID-19",COMPLETED,,PHASE2,142.0,ACTUAL,OrphAI Therapeutics,"The study was potentially limited in its ability to discern a benefit of LAM-002A on viral and clinical endpoints due to the number of participants enrolled, the low baseline viral loads, and the short (4-day) duration of viral load evaluation.",2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,INDUSTRY,,,,,,,2021,1.0
NCT05298332,,2022-02-24,,,2022-11-15,2022-03-17,2022-03-28,ACTUAL,,,,,,,2022-11-15,2022-11-18,ACTUAL,2022-03-29,ACTUAL,2022-03-29,2022-11,2022-11-30,2022-08-22,ACTUAL,2022-08-22,2022-08-22,ACTUAL,2022-08-22,,INTERVENTIONAL,,,"Ethnobridging Study in Healthy Volunteers, Chinese and Japanese Subjects","A Phase 1, Open-Label, 3-Cohort, Parallel, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose ATI-2173 50 mg in Healthy Japanese, Chinese, and Non-Asian Subjects",TERMINATED,,PHASE1,37.0,ACTUAL,"Antios Therapeutics, Inc",,3.0,,Terminated by the Sponsor,f,,,,f,t,f,,,,,,,,,,,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,INDUSTRY,,,,,,,2022,0.0
NCT03431337,,2018-02-07,2021-01-02,,2021-07-19,2018-02-07,2018-02-13,ACTUAL,2021-07-19,2021-08-12,ACTUAL,,,,2021-07-19,2021-08-12,ACTUAL,2018-02-26,ACTUAL,2018-02-26,2021-07,2021-07-31,2020-05-31,ACTUAL,2020-05-31,2020-05-31,ACTUAL,2020-05-31,,INTERVENTIONAL,,,Treatment of Acute Sinusitis With High-Dose vs. Standard-Dose Amoxicillin/Clavulanate,Treatment of Acute Sinusitis With High-Dose vs. Standard-Dose Amoxicillin/Clavulanate: A Confirmation Study,TERMINATED,,PHASE4,157.0,ACTUAL,Albany Medical College,1. Early termination midway in the study after a preliminary analysis demonstrated futility~2. Underestimation of non-serious adverse effects because of dropouts and difficulty contacting participants,2.0,,Futility found by interim analysis,f,,,,f,t,f,,,f,,,Immediately and indefinitely,Contact the corresponding author at sorump@amc.edu,,YES,De-identified IPD will be made available to other researchers by contacting the corresponding author at sorump@amc.edu.,2024-10-16 17:02:14.232292,2024-10-16 17:02:14.232292,OTHER,,,,,,,2020,0.0
NCT03164928,,2017-05-08,2024-06-03,,2024-07-17,2017-05-22,2017-05-24,ACTUAL,2024-07-17,2024-07-19,ACTUAL,,,,2024-07-17,2024-07-19,ACTUAL,2018-05-07,ACTUAL,2018-05-07,2024-07,2024-07-31,2023-12-20,ACTUAL,2023-12-20,2021-12-13,ACTUAL,2021-12-13,,INTERVENTIONAL,,Full Analysis Set (FAS): all participants enrolled into the study.,Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis,"A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis",COMPLETED,,PHASE3,24.0,ACTUAL,Amgen,,2.0,,,f,,,,t,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,INDUSTRY,,,,,,,2023,1.0
NCT02060487,,2014-01-29,2022-02-25,,2022-05-11,2014-02-10,2014-02-12,ESTIMATED,2022-04-15,2022-05-10,ACTUAL,,,,2022-05-11,2022-05-13,ACTUAL,2014-09-22,ACTUAL,2014-09-22,2022-05,2022-05-31,2021-02-26,ACTUAL,2021-02-26,2021-02-26,ACTUAL,2021-02-26,,INTERVENTIONAL,AFFILIATE,All randomized participants were included in the baseline analysis population.,Effects of Oral Sildenafil on Mortality in Adults With PAH,"A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)",TERMINATED,,PHASE4,385.0,ACTUAL,Pfizer,"Study was terminated by Sponsor at recommendation of Data Monitoring Committee after completion of first interim analysis as primary objective was met. For OS and clinical worsening(CW) endpoints, significance level was adjusted to allow for interim analysis. Hence 99.7% CIs were presented instead of 95% CIs. 80mg vs 5mg comparison for OS was primary and it was key secondary for CW. CIs for other dose comparisons for these endpoints were nominal. P-values and CIs for other endpoints were nominal",3.0,,Study was terminated by Sponsor at recommendation of Data Monitoring Committee after completion of first interim analysis as primary objective was met.,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,INDUSTRY,,,,,,,2021,0.0
NCT02407899,,2015-03-31,,,2021-04-18,2015-03-31,2015-04-03,ESTIMATED,,,,,,,2021-04-18,2021-04-20,ACTUAL,2015-03,,2015-03-31,2021-04,2021-04-30,2020-12-31,ACTUAL,2020-12-31,2020-12-30,ACTUAL,2020-12-30,,INTERVENTIONAL,,,Protective Effects of Saxagliptin (And Vitamin D3) on β Cell Function in Adult-onset Latent Autoimmune Diabetes,"A Randomized Controlled, Open-label, Multi-center Study With 104-week Saxagliptin or (and) Vitamin D3 Assessing Protective Effects on Beta Cell Function in Latent Autoimmune Diabetes in Adults (LADA) Treated With Metformin (and Insulin)",COMPLETED,,PHASE4,300.0,ACTUAL,Second Xiangya Hospital of Central South University,,3.0,,,f,,,,f,,f,,,,,,,,,,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,OTHER,,,,,,,2020,1.0
NCT03735433,,2018-11-04,2024-03-06,,2024-04-05,2018-11-06,2018-11-08,ACTUAL,2024-04-05,2024-04-29,ACTUAL,,,,2024-04-05,2024-04-29,ACTUAL,2019-01-15,ACTUAL,2019-01-15,2024-04,2024-04-30,2024-03-01,ACTUAL,2024-03-01,2023-01-30,ACTUAL,2023-01-30,,INTERVENTIONAL,,Baseline analysis population data was not obtained as we did not complete this study. No baseline data was collected.,The Effect of Two Aspirin Dosing Strategies for Obese Women at High Risk for Preeclampsia,The Effect of 81mg vs 162mg ASA for Preeclampsia Prevention in Obese Women at High Risk for Developing Preeclampsia,TERMINATED,,PHASE4,152.0,ACTUAL,Ohio State University,,2.0,,futility,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 10:24:17.206313,2024-10-15 10:24:17.206313,OTHER,,,,,,,2024,0.0
NCT01620788,,2012-05-29,,,2022-07-25,2012-06-13,2012-06-15,ESTIMATED,,,,,,,2022-07-25,2022-07-27,ACTUAL,2019-11-27,ACTUAL,2019-11-27,2022-07,2022-07-31,2023-10,ESTIMATED,2023-10-31,2023-07,ESTIMATED,2023-07-31,,INTERVENTIONAL,,,Comparison of Losartan Associated With Indapamide Versus Hyzaar® in the Hypertension Treatment,"Randomized, Phase 3, Multicenter, Open Label, Evaluating the Effect of the Treatment of Indapamide 1.5mg/Losartan 50mg and Indapamide 1.5mg/Losartan 100mg, Compared With Hyzaar® in the Treatment of Hypertension",SUSPENDED,,PHASE3,636.0,ESTIMATED,EMS,,4.0,,Substancial amendment,f,,,,t,f,f,,,,,,,,,,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,INDUSTRY,,,,,,,2023,0.0
NCT03984604,,2019-06-11,,,2020-09-30,2019-06-11,2019-06-13,ACTUAL,,,,,,,2020-09-30,2020-10-05,ACTUAL,2019-03-21,ACTUAL,2019-03-21,2019-08,2019-08-31,2020-06-17,ACTUAL,2020-06-17,2020-06-17,ACTUAL,2020-06-17,,INTERVENTIONAL,,,Investigation of the Efficacy and Safety of CHI-921 in Insomnia.,"A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Dose-Titration Study on the Efficacy and Safety of CHI-921 on Sleep Initiation and Maintenance in Subjects With Insomnia",TERMINATED,,PHASE2,21.0,ACTUAL,Canopy Growth Corporation,,2.0,,COVID-19,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 10:30:28.70084,2024-10-15 10:30:28.70084,INDUSTRY,,,,,,,2020,0.0
NCT04896320,,2021-05-10,,,2023-06-19,2021-05-17,2021-05-21,ACTUAL,,,,,,,2023-06-19,2023-06-22,ACTUAL,2021-12-15,ACTUAL,2021-12-15,2023-06,2023-06-30,2023-06-19,ACTUAL,2023-06-19,2023-06-19,ACTUAL,2023-06-19,,INTERVENTIONAL,2019-101826,,"Tucatinib With Chemotherapy and Trastuzumab in Advanced Her-2-neu Overexpressing, Previously Treated Breast Cancer.","A Phase 1/2 Study of Tucatinib With Chemotherapy and Trastuzumab in Patients With Previously Treated, Advanced Her-2-Neu Overexpressing Breast Cancer.",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Providence Health & Services,,2.0,,Study will be closed due to zero enrollment.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 10:30:28.70084,2024-10-15 10:30:28.70084,OTHER,,,,,,,2023,0.0
NCT03005106,,2016-12-21,2021-06-18,2020-03-17,2021-07-12,2016-12-22,2016-12-29,ESTIMATED,2021-06-18,2021-07-12,ACTUAL,2020-03-19,2020-03-23,ACTUAL,2021-07-12,2021-07-14,ACTUAL,2017-05-30,ACTUAL,2017-05-30,2021-07,2021-07-31,2020-03-27,ACTUAL,2020-03-27,2019-07-31,ACTUAL,2019-07-31,,INTERVENTIONAL,,All participants,StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements,"A Phase III Open-label, Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of StrataGraft Skin Tissue in Promoting Autologous Skin Tissue Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements and for Which Excision and Autografts Are Clinically Indicated",COMPLETED,,PHASE3,71.0,ACTUAL,Mallinckrodt,,1.0,,,t,,,,t,t,f,,,,,,,,,NO,Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03005106) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,INDUSTRY,,,,,,,2020,1.0
NCT01968590,,2013-10-07,,,2022-05-17,2013-10-19,2013-10-24,ESTIMATED,,,,,,,2022-05-17,2022-05-25,ACTUAL,2017-08-16,ACTUAL,2017-08-16,2022-05,2022-05-31,2022-01-01,ACTUAL,2022-01-01,2022-01-01,ACTUAL,2022-01-01,,INTERVENTIONAL,VitDBoneNF1,,Vitamin D Supplementation for Adults With Neurofibromatosis Type 1 (NF1),A Phase II Trial on the Effect of Low-Dose Versus High-Dose Vitamin D Supplementation on Bone Mass in Adults With Neurofibromatosis Type 1 (NF1),TERMINATED,,PHASE2,26.0,ACTUAL,University of Utah,,2.0,,unable to enroll,f,,,,f,t,f,,,,,,,,,NO,Publication of all study data will be written,2024-10-15 10:30:28.70084,2024-10-15 10:30:28.70084,OTHER,,,,,,,2022,0.0
NCT05197179,,2021-12-16,,,2022-06-30,2022-01-04,2022-01-19,ACTUAL,,,,,,,2022-06-30,2022-07-06,ACTUAL,2021-12-29,ACTUAL,2021-12-29,2022-06,2022-06-30,2022-06-02,ACTUAL,2022-06-02,2022-04-27,ACTUAL,2022-04-27,,INTERVENTIONAL,,,A Bridging Study of FB2001 in Healthy Subjects,"A Randomized, Double-Blind, Placebo-Controlled, Bridging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FB2001 in Healthy Subjects",COMPLETED,,PHASE1,40.0,ACTUAL,Frontier Biotechnologies Inc.,,5.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,INDUSTRY,,,,,,,2022,1.0
NCT04876430,,2021-05-03,,,2022-08-01,2021-05-03,2021-05-06,ACTUAL,,,,,,,2022-08-01,2022-08-03,ACTUAL,2021-05-04,ACTUAL,2021-05-04,2022-08,2022-08-31,2022-03-07,ACTUAL,2022-03-07,2022-03-07,ACTUAL,2022-03-07,,INTERVENTIONAL,ABOVE,,Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With High Level of Resistance to Carbapenems,Open-label Randomized Clinical Trial Comparing Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With Minimal Inhibitory Concentrations for Meropenem Above 32mg/L,TERMINATED,,PHASE2/PHASE3,13.0,ACTUAL,Hospital de Clinicas de Porto Alegre,,2.0,,Very low frequency of recruitment,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,OTHER,,,,,,,2022,0.0
NCT04200456,,2019-12-13,2023-05-15,2022-12-19,2023-08-04,2019-12-13,2019-12-16,ACTUAL,2023-08-04,2023-08-08,ACTUAL,,2023-08-08,ACTUAL,2023-08-04,2023-08-08,ACTUAL,2020-01-31,ACTUAL,2020-01-31,2023-08,2023-08-31,2022-04-27,ACTUAL,2022-04-27,2022-03-21,ACTUAL,2022-03-21,,INTERVENTIONAL,myOpportunITy1,Baseline Characteristics refer to Randomized Set which consisted of all enrolled study participants who were randomized.,"A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)","A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)",TERMINATED,,PHASE3,33.0,ACTUAL,UCB Pharma,,2.0,,Strategic Business Decision; Not a safety decision,f,,,,t,t,f,,,f,,,"Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",https://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-15 10:30:28.70084,2024-10-15 10:30:28.70084,INDUSTRY,,,,,,,2022,0.0
NCT04037072,,2019-07-25,,,2022-04-01,2019-07-25,2019-07-30,ACTUAL,,,,,,,2022-04-01,2022-04-11,ACTUAL,2020-04-03,ACTUAL,2020-04-03,2022-04,2022-04-30,2022-12-15,ESTIMATED,2022-12-15,2022-03-15,ESTIMATED,2022-03-15,,INTERVENTIONAL,,,Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures,GI-108: Randomized Controlled Double-Blinded Trial Assessing the Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures,WITHDRAWN,,PHASE2,0.0,ACTUAL,Fox Chase Cancer Center,,2.0,,Study was not approved for Fox Chase Cancer Center's Research Review Committee (RRC),f,,,,t,t,f,,,f,,,,,,,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,OTHER,,,,,,,2022,0.0
NCT05330000,,2022-02-21,,,2022-04-08,2022-04-08,2022-04-15,ACTUAL,,,,,,,2022-04-08,2022-04-15,ACTUAL,2020-05-22,ACTUAL,2020-05-22,2022-04,2022-04-30,2020-09-16,ACTUAL,2020-09-16,2020-07-08,ACTUAL,2020-07-08,,INTERVENTIONAL,,,Comparative Study on Tolerance and Pharmacokinetics of Voriconazole for Injection in Healthy Subjects,Comparative Study on Tolerance and Pharmacokinetics of Voriconazole for Injection in Healthy Subjects,COMPLETED,,PHASE1,48.0,ACTUAL,The Affiliated Hospital of Qingdao University,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,OTHER,,,,,,,2020,1.0
NCT03547206,,2018-05-24,,,2020-10-08,2018-05-24,2018-06-06,ACTUAL,,,,,,,2020-10-08,2020-10-12,ACTUAL,2018-07-10,ACTUAL,2018-07-10,2020-10,2020-10-31,2020-09-27,ACTUAL,2020-09-27,2020-09-27,ACTUAL,2020-09-27,,INTERVENTIONAL,,,Efficacy & Safety of RPh201 Treatment in Patients With Previous Nonarteritic Anterior Ischemic Optic Neuropathy (NAION),A Double-Masked Clinical Study Evaluating the Efficacy and Safety of RPh201 Treatment in Participants With Previous NAION,TERMINATED,,PHASE2,165.0,ACTUAL,Regenera Pharma Ltd,,4.0,,Terminated by Sponsor,f,,,,t,t,f,,,,,,,,,NO,There is not a plan to make individual participant data available.,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,INDUSTRY,,,,,,,2020,0.0
NCT04317430,,2020-03-18,,,2022-10-19,2020-03-19,2020-03-23,ACTUAL,,,,,,,2022-10-19,2022-10-20,ACTUAL,2020-02-01,ACTUAL,2020-02-01,2022-10,2022-10-31,2022-04-01,ACTUAL,2022-04-01,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,,,Niclosamide Role in Diabetic Nephropathy,Possible Role of Niclosamide in Patients With Diabetic Kidney Disease: Randomized Controlled Study,COMPLETED,,PHASE3,60.0,ACTUAL,Tanta University,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,OTHER,,,,,,,2022,1.0
NCT02730091,,2016-03-25,,,2021-01-29,2016-03-31,2016-04-06,ESTIMATED,,,,,,,2021-01-29,2021-02-01,ACTUAL,2016-02-24,ACTUAL,2016-02-24,2021-01,2021-01-31,2020-03-23,ACTUAL,2020-03-23,2020-03-23,ACTUAL,2020-03-23,,INTERVENTIONAL,VICTORIANE,,"A Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease","A Randomized Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease",TERMINATED,,PHASE3,98.0,ACTUAL,Centre Hospitalier Universitaire de Besancon,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,OTHER,,,,,,,2020,0.0
NCT04729608,,2021-01-25,,,2023-10-26,2021-01-27,2021-01-28,ACTUAL,,,,,,,2023-10-26,2023-10-30,ACTUAL,2021-04-22,ACTUAL,2021-04-22,2023-10,2023-10-31,2023-08-04,ACTUAL,2023-08-04,2023-08-04,ACTUAL,2023-08-04,,INTERVENTIONAL,AXLerate-OC,,Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer,"A Phase 3, Randomized, Double-Blind, Placebo/Paclitaxel-Controlled Study of Batiraxcept (AVB-S6-500) in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer (AXLerate-OC)",TERMINATED,,PHASE3,366.0,ACTUAL,"Aravive, Inc.",,2.0,,There were no significant differences in median PFS between batiraxcept + paclitaxel or paclitaxel alone arms. There was no detriment to overall survival. No new safety signals were identified.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,INDUSTRY,,,,,,,2023,0.0
NCT03611556,,2018-05-18,2023-07-20,,2023-09-08,2018-07-26,2018-08-02,ACTUAL,2023-09-08,2023-10-03,ACTUAL,,,,2023-09-08,2023-10-03,ACTUAL,2018-06-21,ACTUAL,2018-06-21,2023-09,2023-09-30,2022-07-22,ACTUAL,2022-07-22,2022-07-22,ACTUAL,2022-07-22,,INTERVENTIONAL,,As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.,MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.,"A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) With or Without Durvalumab in Combination With Chemotherapy in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma",COMPLETED,,PHASE1/PHASE2,213.0,ACTUAL,MedImmune LLC,"Dose escalation phase: Participants not enrolled in oleclumab 750 mg cohort. Dose expansion phase: Outcomes of mFOLFOX cohorts not included as enrollment was not opened. Non-compartmental PK data analysis were planned to be performed from each dose cohort if data allowed, but as sparse PK samples were collected, no non-compartmental PK parameters were calculated. Consequently, PK concentration time data only have been reported.",7.0,,,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,INDUSTRY,,,,,,,2022,1.0
NCT04323800,,2020-03-24,2022-04-20,,2022-04-22,2020-03-26,2020-03-27,ACTUAL,2022-04-20,2022-04-22,ACTUAL,,,,2022-04-22,2022-04-26,ACTUAL,2020-06-10,ACTUAL,2020-06-10,2022-04,2022-04-30,2021-06-22,ACTUAL,2021-06-22,2021-04-22,ACTUAL,2021-04-22,,INTERVENTIONAL,CSSC-001,,Convalescent Plasma to Stem Coronavirus (CSSC-001),"Convalescent Plasma to Stem Coronavirus: A Randomized, Blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19",COMPLETED,,PHASE2,180.0,ACTUAL,Johns Hopkins University,,2.0,,,,,,,t,t,f,,,f,,,,,,NO,Sharing is governed by Johns Hopkins University Institutional Guidelines,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,OTHER,,,,,,,2021,1.0
NCT02606045,,2015-11-05,2024-03-04,,2024-06-27,2015-11-12,2015-11-17,ESTIMATED,2024-06-27,2024-07-01,ACTUAL,,,,2024-06-27,2024-07-01,ACTUAL,2019-02-07,ACTUAL,2019-02-07,2024-06,2024-06-30,2022-08-30,ACTUAL,2022-08-30,2022-04-30,ACTUAL,2022-04-30,,INTERVENTIONAL,VWDMin,,Minimize Menorrhagia in Women With Von Willebrand Disease,"Prospective, Randomized, Crossover Trial Comparing Recombinant Von Willebrand Factor (rVWF) vs. Tranexamic Acid (TA) to Minimize Menorrhagia in Women With Von Willebrand Disease: The VWD Minimize Study",TERMINATED,,PHASE3,39.0,ACTUAL,University of Pittsburgh,,2.0,,The study stopped early due to slow recruitment.,f,,,,t,t,f,,,,,,Within 12 months of trial completion.,"Qualified investigators will have access to data and bio specimens, consistent with data sharing policies and applicable laws, and upon receipt of a Research Materials Distribution Agreement, data will be transferred by secure transfers through the BioLINCC website.",,YES,"The IPD to be shared include individual bleeding data (PBAC), cycle severity score (CSR), cycle length (CL), quality of life by four scales (SF-36, Ruta, CDC-HRQoL-14, CES-D), satisfaction survey, VWF assays, VWF genotype.",2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,OTHER,,,,,,,2022,0.0
NCT05652907,,2022-11-23,,,2023-07-05,2022-12-08,2022-12-15,ACTUAL,,,,,,,2023-07-05,2023-07-06,ACTUAL,2023-01-19,ACTUAL,2023-01-19,2023-02,2023-02-28,2023-05-24,ACTUAL,2023-05-24,2023-05-24,ACTUAL,2023-05-24,,INTERVENTIONAL,,,Safety and Efficacy of FSD201 for the Treatment of Chronic Pain Associated With Idiopathic MCAS (MCAD),"A Randomized, Double-Blind Placebo Controlled Parallel Group Study of Safety and Efficacy of FSD201 in Patients With Chronic Widespread Musculoskeletal Nociplastic Pain Associated With Idiopathic Mast Cell Activation Syndrome (Disorder)",TERMINATED,,PHASE2,2.0,ACTUAL,Quantum Biopharma,,2.0,,For business reasons and not for reasons related to safety or efficacy,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,INDUSTRY,,,,,,,2023,0.0
NCT03978494,,2019-06-05,,,2019-09-12,2019-06-05,2019-06-07,ACTUAL,,,,,,,2019-09-12,2019-09-17,ACTUAL,2019-09-02,ESTIMATED,2019-09-02,2019-09,2019-09-30,2020-05-03,ESTIMATED,2020-05-03,2020-05-03,ESTIMATED,2020-05-03,,INTERVENTIONAL,TODAY,,Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients.,"Randomized, Multicenter, Open-Label, Two-period, Two-sequence Crossover Comparative Pharmacokinetic Study of Generic Tacrolimus (Sandoz) and Advagraf® in Stable Renal Transplant Patients (TODAY)",WITHDRAWN,,PHASE1,0.0,ACTUAL,Sandoz,,2.0,,company decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,INDUSTRY,,,,,,,2020,0.0
NCT04842721,,2021-04-11,,,2022-07-21,2021-04-11,2021-04-13,ACTUAL,,,,,,,2022-07-21,2022-07-25,ACTUAL,2021-07,ESTIMATED,2021-07-31,2022-07,2022-07-31,2021-12,ESTIMATED,2021-12-31,2021-10,ESTIMATED,2021-10-31,,INTERVENTIONAL,,,Effect of Hypertonic Saturated Saline Mouth Rinse on Covid-19 Virus in Vivo.,Effect of Prolonged Mouth Rinse With Hypertonic Saturated Saline Solution on the Naso-Pharyngeal Viral Load of Covid-19 Virus in Vivo.,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Batroussy, Rafik",,2.0,,Not yet meeting Health Canada's requirements for Clinical Trials,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,OTHER,,,,,,,2021,0.0
NCT04427774,,2020-06-09,,,2021-07-19,2020-06-09,2020-06-11,ACTUAL,,,,,,,2021-07-19,2021-07-20,ACTUAL,2020-06-29,ACTUAL,2020-06-29,2021-07,2021-07-31,2021-04-27,ACTUAL,2021-04-27,2021-02-08,ACTUAL,2021-02-08,,INTERVENTIONAL,,,A Study of Surufatinib Plus Sintilimab in Patients With Advanced Solid Tumor,"A Phase Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Surufatinib Plus Sintilimab in Patients With Advanced Solid Tumor",TERMINATED,,PHASE1,8.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,1.0,,"Policy change, not for security reasons",f,,,,f,f,f,,,,,,,,,,,2024-10-15 10:30:28.70084,2024-10-15 10:30:28.70084,INDUSTRY,,,,,,,2021,0.0
NCT02384122,,2015-03-04,,,2023-05-22,2015-03-09,2015-03-10,ESTIMATED,,,,,,,2023-05-22,2023-05-24,ACTUAL,2015-09,ACTUAL,2015-09-30,2023-04,2023-04-30,2023-05,ACTUAL,2023-05-31,2022-07,ACTUAL,2022-07-31,,INTERVENTIONAL,OCEAN,,Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias,"A Multicenter, Randomized, Open-label Clinical Trial Assessing the Efficacy of Octreotide in Decreasing Blood and Iron Requirements in Patients With Refractory Anemia Due to Angiodysplasias",COMPLETED,,PHASE3,62.0,ACTUAL,Radboud University Medical Center,,2.0,,,f,,,,t,,,,,,,,,Data sharing agreement,,YES,"Deidentified individual participant data and a data dictionary defining each field in the set will be available, upon reasonable request to Lia Goltstein and subjected to an appropriate data sharing agreement.",2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,OTHER,,,,,,,2023,1.0
NCT03496298,,2018-04-05,2021-09-16,,2021-09-16,2018-04-05,2018-04-12,ACTUAL,2021-09-16,2021-10-15,ACTUAL,,,,2021-09-16,2021-10-15,ACTUAL,2018-04-27,ACTUAL,2018-04-27,2021-08,2021-08-31,2020-12-10,ACTUAL,2020-12-10,2020-12-10,ACTUAL,2020-12-10,,INTERVENTIONAL,AMPLITUDE-O,Analysis was performed on Intent-to-treat (ITT) population that included all randomized participants irrespective of compliance with the study protocol and procedures and were analyzed in the treatment group to which they were randomized.,Effect of Efpeglenatide on Cardiovascular Outcomes,"A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular Risk",TERMINATED,,PHASE3,4076.0,ACTUAL,Sanofi,The study was terminated early by the Sponsor but not due to any safety concerns.,3.0,,"Sponsor decision to cancel TRIAL, not related to safety concern",f,,,,t,t,f,,,,,,,,,NO,No plan to share individual participant data (IPD) by Sanofi: product rights transferred to Hanmi pharmaceutical.,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,INDUSTRY,,,,,,,2020,0.0
NCT04252612,,2020-01-30,,,2023-06-27,2020-01-30,2020-02-05,ACTUAL,,,,,,,2023-06-27,2023-06-28,ACTUAL,2020-01-30,ACTUAL,2020-01-30,2023-06,2023-06-30,2023-06-26,ACTUAL,2023-06-26,2023-06-26,ACTUAL,2023-06-26,,INTERVENTIONAL,,,Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study,Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,3.0,,Poor accrual,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,OTHER,,,,,,,2023,0.0
NCT03345836,,2017-11-15,2022-07-18,,2022-07-18,2017-11-15,2017-11-17,ACTUAL,2022-07-18,2022-08-15,ACTUAL,,,,2022-07-18,2022-08-15,ACTUAL,2017-11-29,ACTUAL,2017-11-29,2022-07,2022-07-31,2021-08-11,ACTUAL,2021-08-11,2021-08-11,ACTUAL,2021-08-11,,INTERVENTIONAL,,"Intent-to-Treat (ITT) Population for the 12-week DB Induction Period (Part 1) i.e., ITT1 included all randomized participants who received at least one dose of DB study drug during Part 1. ITT Population for the 12-week OL Induction Period (Part 2) i.e., ITT2 included all participants who received at least one dose of study drug in Part 2.",A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy",COMPLETED,,PHASE3,624.0,ACTUAL,AbbVie,,6.0,,,f,,,,t,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,INDUSTRY,,,,,,,2021,1.0
NCT05082688,,2021-01-22,,,2023-06-28,2021-10-05,2021-10-19,ACTUAL,,,,,,,2023-06-28,2023-06-29,ACTUAL,2021-09-20,ACTUAL,2021-09-20,2023-06,2023-06-30,2023-05-17,ACTUAL,2023-05-17,2023-05-17,ACTUAL,2023-05-17,,INTERVENTIONAL,,,Age Differences in Influenza and Herpes Zoster Vaccine Responses (INFLUENZA-SHINGRIX),Exploratory Study Into Age-related Immunological Differences Related to Immunogenicity in Influenza Vaccination and Herpes Zoster Vaccination,COMPLETED,,PHASE2,148.0,ACTUAL,Radboud University Medical Center,,6.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,OTHER,,,,,,,2023,1.0
NCT04571944,,2020-09-25,2023-12-12,,2023-12-12,2020-09-25,2020-10-01,ACTUAL,2023-12-12,2024-05-20,ACTUAL,,,,2023-12-12,2024-05-20,ACTUAL,2020-10-22,ACTUAL,2020-10-22,2023-12,2023-12-31,2022-12-23,ACTUAL,2022-12-23,2022-12-23,ACTUAL,2022-12-23,,INTERVENTIONAL,,,Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085),"A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of MK-4305 (Suvorexant) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium",COMPLETED,,PHASE3,207.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,f,f,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,INDUSTRY,,,,,,,2022,1.0
NCT04245722,,2020-01-18,,,2023-10-25,2020-01-26,2020-01-29,ACTUAL,,,,,,,2023-10-25,2023-10-26,ACTUAL,2020-03-19,ACTUAL,2020-03-19,2023-10,2023-10-31,2023-09-27,ACTUAL,2023-09-27,2023-09-27,ACTUAL,2023-09-27,,INTERVENTIONAL,,,FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies,"A Phase I, Open-Label, Multicenter Study of FT596 as a Monotherapy and in Combination With Rituximab or Obinutuzumab in Subjects With Relapsed/Refractory B-cell Lymphoma and Chronic Lymphocytic Leukemia",TERMINATED,,PHASE1,98.0,ACTUAL,Fate Therapeutics,,5.0,,The study was terminated by the Sponsor.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,INDUSTRY,,,,,,,2023,0.0
NCT05124210,,2021-11-16,2023-12-14,,2023-12-14,2021-11-16,2021-11-17,ACTUAL,2023-12-14,2024-01-03,ACTUAL,,,,2023-12-14,2024-01-03,ACTUAL,2021-12-16,ACTUAL,2021-12-16,2023-12,2023-12-31,2023-06-14,ACTUAL,2023-06-14,2023-06-14,ACTUAL,2023-06-14,,INTERVENTIONAL,COMET-PACE,,"Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19","An Open-label, Non-comparator, Multicenter Study to Describe the Pharmacokinetics (PK), Pharmacodynamics (PD; Viral Load) and Safety Following a Single Intravenous or Intramuscular Dose of Sotrovimab in Pediatric Participants With Mild to Moderate COVID-19 at High Risk of Disease Progression",TERMINATED,,PHASE2,8.0,ACTUAL,GlaxoSmithKline,,2.0,,Decrease in in-vitro neutralization of study drug against circulating SARS-CoV-2 variants,f,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,INDUSTRY,,,,,,,2023,0.0
NCT04073134,,2019-08-27,,,2024-08-05,2019-08-28,2019-08-29,ACTUAL,,,,,,,2024-08-05,2024-08-06,ACTUAL,2019-09-11,ACTUAL,2019-09-11,2024-08,2024-08-31,2022-05-27,ACTUAL,2022-05-27,2022-03-27,ACTUAL,2022-03-27,,INTERVENTIONAL,CHORAL,,The CHORAL Flow Study,Cholesterol Reduction With Evolocumab and Coronary MicrovascuLar Function and Coronary Flow: The CHORAL Flow Study,TERMINATED,,PHASE4,12.0,ACTUAL,Imperial College London,,2.0,,Funding withdrawn,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,OTHER,,,,,,,2022,0.0
NCT03989232,,2019-06-14,2021-08-04,,2023-02-10,2019-06-14,2019-06-18,ACTUAL,2021-09-24,2021-10-22,ACTUAL,,,,2023-02-10,2023-02-13,ACTUAL,2019-06-19,ACTUAL,2019-06-19,2023-02,2023-02-28,2020-11-09,ACTUAL,2020-11-09,2020-09-18,ACTUAL,2020-09-18,,INTERVENTIONAL,SUSTAIN FORTE,The full analysis set (FAS) included all randomized participants.,A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes,Efficacy and Safety of Semaglutide 2.0 mg s.c. Once-weekly Compared to Semaglutide 1.0 mg s.c. Once-weekly in Subjects With Type 2 Diabetes,COMPLETED,,PHASE3,961.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,INDUSTRY,,,,,,,2020,1.0
NCT02432846,,2015-04-15,2022-04-21,,2022-07-23,2015-04-28,2015-05-04,ESTIMATED,2022-07-23,2022-08-22,ACTUAL,,,,2022-07-23,2022-08-22,ACTUAL,2015-04,,2015-04-30,2022-07,2022-07-31,2021-01-31,ACTUAL,2021-01-31,2021-01-31,ACTUAL,2021-01-31,,INTERVENTIONAL,MERECA,The 6 groups are not mutually exclusive. The patients are presented both separately by risk stratum and treatment (4 groups) and by treatment group overall (2 groups) where high-risk and intermediate-risk strata are combined. This split of baseline characteristics provides transparency for efficacy outcomes that are analysed by these 6 groups.,Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC),"An Open-label, Randomized, Controlled, Multicenter, Phase II Study Evaluating Safety and Efficacy of Intratumorally Administered Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy, Compared to Sunitinib Post-nephrectomy in Metastatic Renal Cell Carcinoma Patients",COMPLETED,,PHASE2,88.0,ACTUAL,Mendus,Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:30:28.70084,2024-10-15 10:30:28.70084,INDUSTRY,,,,,,,2021,1.0
NCT02036502,,2014-01-13,2021-03-02,,2021-03-12,2014-01-13,2014-01-15,ESTIMATED,2021-03-12,2021-04-08,ACTUAL,,,,2021-03-12,2021-04-08,ACTUAL,2014-02-14,ACTUAL,2014-02-14,2021-03,2021-03-31,2020-03-19,ACTUAL,2020-03-19,2020-03-19,ACTUAL,2020-03-19,,INTERVENTIONAL,,The analysis population consisted of all randomized participants,A Study of Pembrolizumab (MK-3475) in Combination With Standard of Care Treatments in Participants With Multiple Myeloma (MK-3475-023/KEYNOTE-023),A Phase I Multi-Cohort Trial of Pembrolizumab (MK-3475) in Combination With Backbone Treatments for Subjects With Multiple Myeloma,TERMINATED,,PHASE1,77.0,ACTUAL,Merck Sharp & Dohme LLC,Enrollment of participants into this study was stopped after the FDA implemented a clinical hold after determining the risks of pembrolizumab + pomalidomide or lenalidomide outweighed any potential benefit for participants with multiple myeloma.,8.0,,Business Reasons,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 10:30:28.70084,2024-10-15 10:30:28.70084,INDUSTRY,,,,,,,2020,0.0
NCT03954106,,2019-05-15,2021-09-22,,2021-11-10,2019-05-15,2019-05-17,ACTUAL,2021-11-10,2021-12-09,ACTUAL,,,,2021-11-10,2021-12-09,ACTUAL,2019-10-04,ACTUAL,2019-10-04,2021-11,2021-11-30,2020-09-30,ACTUAL,2020-09-30,2020-09-18,ACTUAL,2020-09-18,,INTERVENTIONAL,,Baseline demographics were assessed in the Safety Analysis Set (N=25) which was comprised of the Part 1: Defibrotide 2.5 mg/kg (n=4) and the combined Part 1: Defibrotide 6.25 mg/kg and Phase 2: RP2D 6.25 mg/kg (n=21). The baseline demographics are reported in this format as per the Statistical Analysis Plan.,A Safety and Efficacy Study of Defibrotide in the Prevention of Chimeric Antigen Receptor-T-cell-associated Neurotoxicity,"Prospective, Multicenter, Open-Label, Single Arm, Phase 2 Study to Evaluate the Safety and Efficacy of Defibrotide in the Prevention of Chimeric Antigen Receptor-T-cell-associated Neurotoxicity in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma Receiving Axicabtagene Ciloleucel (Yescarta®)",TERMINATED,,PHASE2,25.0,ACTUAL,Jazz Pharmaceuticals,,1.0,,Primary endpoint would unlikely to be met based on the unplanned interim assessment on the first 20 efficacy evaluable patients.,f,,,,,t,f,,,f,,,,,,,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,INDUSTRY,,,,,,,2020,0.0
NCT02956486,,2016-11-03,2021-01-14,,2021-01-14,2016-11-03,2016-11-06,ESTIMATED,2021-01-14,2021-02-03,ACTUAL,,,,2021-01-14,2021-02-03,ACTUAL,2016-10-20,ACTUAL,2016-10-20,2021-01,2021-01-31,2020-01-15,ACTUAL,2020-01-15,2020-01-15,ACTUAL,2020-01-15,,INTERVENTIONAL,MissionAD1,The SAS was the group of participants who received at least 1 dose of study drug in the core phase and had at least 1 post-dose safety assessment.,A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's Disease,"A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study With an Open-Label Extension Phase to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease",TERMINATED,,PHASE3,2212.0,ACTUAL,Eisai Inc.,This study was terminated early due to an unfavorable risk-benefit ratio including no evidence of potential efficacy and the adverse event profile in participants with drug treatment was worse than that in participants who received placebo. The small sample size at the 24 month time point of the core phase limits the interpretability of the data.,3.0,,"Due to an unfavorable risk-benefit ratio including no evidence of potential efficacy, and the adverse event profile of E2609 being worse than placebo.",f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 10:30:28.70084,2024-10-15 10:30:28.70084,INDUSTRY,,,,,,,2020,0.0
NCT03977727,,2019-04-17,2020-06-01,,2020-09-09,2019-06-04,2019-06-06,ACTUAL,2020-08-20,2020-09-09,ACTUAL,,,,2020-09-09,2020-09-29,ACTUAL,2019-06-11,ACTUAL,2019-06-11,2020-08,2020-08-31,2020-04-20,ACTUAL,2020-04-20,2020-03-09,ACTUAL,2020-03-09,,INTERVENTIONAL,,,FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump,"An Exploratory, Single-center, Randomized, Open Label, Active-control, Cross-over Trial Comparing the Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart (Fiasp®) Compared to NovoLog® Used in the Medtronic 670G Closed Loop System in Adults With Type 1 Diabetes",COMPLETED,,PHASE3,40.0,ACTUAL,"Texas Diabetes & Endocrinology, P.A.",,2.0,,,f,,,,f,t,t,,,t,,,,,,,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,OTHER,,,,,,,2020,1.0
NCT03117049,,2017-04-12,2021-10-21,,2024-05-02,2017-04-14,2017-04-17,ACTUAL,2022-04-25,2022-04-26,ACTUAL,,,,2024-05-02,2024-05-06,ACTUAL,2017-06-13,ACTUAL,2017-06-13,2024-05,2024-05-31,2023-12-04,ACTUAL,2023-12-04,2020-02-10,ACTUAL,2020-02-10,,INTERVENTIONAL,,,Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52),"A Multicenter, Randomized, Double-Blind Trial in Subjects With Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)",COMPLETED,,PHASE3,550.0,ACTUAL,Ono Pharmaceutical Co. Ltd,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,INDUSTRY,,,,,,,2023,1.0
NCT04593940,,2020-09-23,2023-01-23,,2023-09-14,2020-10-19,2020-10-20,ACTUAL,2023-04-20,2023-04-21,ACTUAL,,,,2023-09-14,2023-09-25,ACTUAL,2020-10-15,ACTUAL,2020-10-15,2023-09,2023-09-30,2022-03-05,ACTUAL,2022-03-05,2022-01-30,ACTUAL,2022-01-30,,INTERVENTIONAL,ACTIV-1 IM,,Immune Modulators for Treating COVID-19,Randomized Master Protocol for Immune Modulators for Treating COVID-19,COMPLETED,,PHASE3,1971.0,ACTUAL,Duke University,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,OTHER,,,,,,,2022,1.0
NCT04128956,,2019-10-14,,,2024-02-27,2019-10-14,2019-10-16,ACTUAL,,,,,,,2024-02-27,2024-03-01,ACTUAL,2020-03-11,ACTUAL,2020-03-11,2024-02,2024-02-29,2024-02-21,ACTUAL,2024-02-21,2024-02-21,ACTUAL,2024-02-21,,INTERVENTIONAL,ARIVA,,Aspirin® Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With PTS,"Aspirin® Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With Post-thrombotic Syndrome a Multi-center, International, Randomized, Open Label, Controlled Trial",TERMINATED,,PHASE2,172.0,ACTUAL,University of Zurich,,2.0,,Recommendation by DSMB,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,OTHER,,,,,,,2024,0.0
NCT03674242,,2018-09-14,,,2022-07-27,2018-09-14,2018-09-17,ACTUAL,,,,,,,2022-07-27,2022-08-01,ACTUAL,2019-06-13,ACTUAL,2019-06-13,2022-07,2022-07-31,2022-03-31,ACTUAL,2022-03-31,2022-03-31,ACTUAL,2022-03-31,,INTERVENTIONAL,,,Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone for the Treatment of TNBC (TRYbeCA-2),A Randomized Phase 2/3 Study of Eryaspase in Combination With Gemcitabine and Carboplatin Chemotherapy Versus Chemotherapy Alone for the Treatment of Patients With Metastatic or Locally Recurrent Triple-Negative Breast Cancer,TERMINATED,,PHASE2/PHASE3,27.0,ACTUAL,ERYtech Pharma,,2.0,,sponsor decision,f,,,,t,f,f,,,,,,,,,,,2024-10-15 10:30:28.70084,2024-10-15 10:30:28.70084,INDUSTRY,,,,,,,2022,0.0
NCT01602302,,2012-05-16,,,2020-11-26,2012-05-17,2012-05-18,ESTIMATED,,,,,,,2020-11-26,2020-12-01,ACTUAL,2012-06,,2012-06-30,2020-11,2020-11-30,2020-11-19,ACTUAL,2020-11-19,2020-11-19,ACTUAL,2020-11-19,,INTERVENTIONAL,RA-BioStop,,Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid Arthritis,Ultrasound as Biomarker for Withdrawal of Biological DMARDs in Rheumatoid Arthritis,TERMINATED,,PHASE4,40.0,ACTUAL,Medical University of Graz,,1.0,,low recruitment,f,,,,t,,,,,,,,,,,,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,OTHER,,,,,,,2020,0.0
NCT04510493,,2020-08-11,,,2021-09-07,2020-08-11,2020-08-12,ACTUAL,,,,,,,2021-09-07,2021-09-08,ACTUAL,2020-10-23,ACTUAL,2020-10-23,2021-09,2021-09-30,2021-08-17,ACTUAL,2021-08-17,2021-08-17,ACTUAL,2021-08-17,,INTERVENTIONAL,CanCovDia,,Canakinumab in Patients With COVID-19 and Type 2 Diabetes,Canakinumab in Patients With COVID-19 and Type 2 Diabetes - CanCovDia Trial,COMPLETED,,PHASE3,116.0,ACTUAL,"University Hospital, Basel, Switzerland",,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,OTHER,,,,,,,2021,1.0
NCT04025307,,2019-07-11,,,2021-03-10,2019-07-16,2019-07-18,ACTUAL,,,,,,,2021-03-10,2021-03-12,ACTUAL,2019-08-05,ACTUAL,2019-08-05,2021-03,2021-03-31,2020-12-29,ACTUAL,2020-12-29,2020-12-29,ACTUAL,2020-12-29,,INTERVENTIONAL,,,"Phase I Trial of bacTRL-IL-12 in Adult Subjects With Advanced, Treatment-refractory Solid Tumours","A Multi-centre, Open-label, Phase I Trial of bacTRL-IL-12 in Adult Subjects With Advanced, Treatment-refractory Solid Tumours",TERMINATED,,PHASE1,5.0,ACTUAL,Iqvia Pty Ltd,,1.0,,Sponsor decision,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 10:30:28.70084,2024-10-15 10:30:28.70084,INDUSTRY,,,,,,,2020,0.0
NCT04469114,,2020-07-10,,,2021-08-02,2020-07-10,2020-07-13,ACTUAL,,,,,,,2021-08-02,2021-08-09,ACTUAL,2020-09-16,ACTUAL,2020-09-16,2020-07,2020-07-31,2021-01-09,ACTUAL,2021-01-09,2021-01-09,ACTUAL,2021-01-09,,INTERVENTIONAL,,,Tofacitinib in Hospitalized Patients With COVID-19 Pneumonia,"A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Trial of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia",COMPLETED,,PHASE3,289.0,ACTUAL,Hospital Israelita Albert Einstein,,2.0,,,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-15 10:30:28.70084,2024-10-15 10:30:28.70084,OTHER,,,,,,,2021,1.0
NCT04777708,,2021-02-25,,,2023-03-22,2021-02-26,2021-03-02,ACTUAL,,,,,,,2023-03-22,2023-03-24,ACTUAL,2021-10-13,ACTUAL,2021-10-13,2023-03,2023-03-31,2023-03-13,ACTUAL,2023-03-13,2023-03-13,ACTUAL,2023-03-13,,INTERVENTIONAL,,,BO-112 and Pembrolizumab for the Treatment of PD-1/PD-L1 Refractory Liver Cancer,Pilot Feasibility Study of Intratumoral BO-112 in Combination With Pembrolizumab for Advanced Hepatocellular Carcinoma,TERMINATED,,EARLY_PHASE1,1.0,ACTUAL,Jonsson Comprehensive Cancer Center,,1.0,,Withdrawn by sponsor,,,,,t,t,f,,,f,,,,,,,,2024-10-15 10:30:28.70084,2024-10-15 10:30:28.70084,OTHER,,,,,,,2023,0.0
NCT01986348,,2013-10-17,2021-06-16,,2023-01-24,2013-11-11,2013-11-18,ESTIMATED,2021-07-30,2021-08-02,ACTUAL,,,,2023-01-24,2023-01-26,ACTUAL,2014-03-03,ACTUAL,2014-03-03,2023-01,2023-01-31,2020-01-23,ACTUAL,2020-01-23,2020-01-23,ACTUAL,2020-01-23,,INTERVENTIONAL,KING,Safety population consisted of all participants who had received any amount of study treatment.,Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Participants With Recurrent Gliomas,A Phase 2 Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Patients With Recurrent Gliomas,TERMINATED,,PHASE2,76.0,ACTUAL,Karyopharm Therapeutics Inc,Study was terminated due to Sponsor decision (all except 1 patient were off-treatment and 2 patients were in survival follow-up).,4.0,,Study was terminated due to Sponsor decision (all except 1 patient were off-treatment and 2 patients were in survival follow-up),f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,INDUSTRY,,,,,,,2020,0.0
NCT04766996,,2021-02-19,2023-04-05,,2023-06-15,2021-02-19,2021-02-23,ACTUAL,2023-06-15,2023-06-22,ACTUAL,,,,2023-06-15,2023-06-22,ACTUAL,2021-05-17,ACTUAL,2021-05-17,2023-06,2023-06-30,2021-12-27,ACTUAL,2021-12-27,2021-12-27,ACTUAL,2021-12-27,,INTERVENTIONAL,,"Baseline information is not available for the retrospective control group as the study was terminated prior to creating this study arm. Only minimal, optional, demographic information was collected from professional staff to maintain anonymity among respondents and to ease their burden of study related activities.",PROUD Study - Preventing Opioid Use Disorders,PROUD Study - Preventing Opioid Use Disorders,TERMINATED,,PHASE4,57.0,ACTUAL,Emory University,"This study aimed to enroll a total of 170 participants. Due to staffing issues and the coronavirus disease 2019 (COVID-19) pandemic, this trial was terminated early and therefore the retrospective data was not collected.",3.0,,"Loss of surgery team member deemed the study procedures impossible to achieve, and no replacement could be found in a timely manner to complete trial as initially planned.",f,,,,t,t,f,,,f,,,Data will be available for sharing beginning 6 months and ending 36 months following article publication.,Data will be available for sharing with investigators whose proposed use of the data have been approved by an independent review committee identified for that purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in Emory University's data warehouse but without investigator support other than deposited metadata. Information regarding the Emory Dataverse can be found at: http://sco.library.emory.edu/dataverse/index.html,http://sco.library.emory.edu/dataverse/index.html,YES,Individual participant data that underlie the results reported in peer reviewed publication(s) will be shared after de-identification.,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,OTHER,,,,,,,2021,0.0
NCT03316170,,2017-09-26,2021-03-23,,2021-06-16,2017-10-18,2017-10-20,ACTUAL,2021-06-16,2021-07-08,ACTUAL,,,,2021-06-16,2021-07-08,ACTUAL,2017-11-06,ACTUAL,2017-11-06,2021-06,2021-06-30,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,Each participant is 1 unit in the analysis,"Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors","Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors",COMPLETED,,PHASE2,49.0,ACTUAL,University of Kentucky,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 19:39:38.279222,2024-10-15 19:39:38.279222,OTHER,,,,,,,2020,1.0
NCT05107739,,2021-10-04,,,2024-05-02,2021-10-25,2021-11-04,ACTUAL,,,,,,,2024-05-02,2024-05-03,ACTUAL,2021-12-22,ACTUAL,2021-12-22,2024-05,2024-05-31,2023-05-09,ACTUAL,2023-05-09,2023-05-09,ACTUAL,2023-05-09,,INTERVENTIONAL,,,A Study of DeTIL-0255 in Adults With Advanced Malignancies,A Phase 1 Safety and Tolerability Study of DeTIL-0255 in Adults With Advanced Malignancies,TERMINATED,,PHASE1,5.0,ACTUAL,"Nurix Therapeutics, Inc.",,4.0,,Sponsor Decision,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,INDUSTRY,,,,,,,2023,0.0
NCT05433298,,2022-05-19,,,2023-05-04,2022-06-23,2022-06-27,ACTUAL,,,,,,,2023-05-04,2023-05-08,ACTUAL,2022-05-01,ACTUAL,2022-05-01,2023-05,2023-05-31,2023-03-31,ACTUAL,2023-03-31,2022-11-26,ESTIMATED,2022-11-26,,INTERVENTIONAL,,,Mesenchymal Stromal Cells for the Treatment of Patients With COVID-19.,Multicenter Phase I/IIa Study of Mesenchymal Stromal Cells for the Treatment of Patients With SARS-CoV-2 Pneumonia.,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Pontifícia Universidade Católica do Paraná,,2.0,,"No patient could be included because there was a decrease in the number of patients with complications due to COVID-19. Also, a Brazilian government agency granted this clinical trial, and the project execution period ended in March 2023.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,OTHER,,,,,,,2023,0.0
NCT04329611,,2020-03-29,,,2020-07-29,2020-03-31,2020-04-01,ACTUAL,,,,,,,2020-07-29,2020-07-31,ACTUAL,2020-04-13,ACTUAL,2020-04-13,2020-07,2020-07-31,2020-07-20,ACTUAL,2020-07-20,2020-07-20,ACTUAL,2020-07-20,,INTERVENTIONAL,,,ALBERTA HOPE COVID-19 for the Prevention of Severe COVID19 Disease,"A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Oral Hydroxychloroquine for the Treatment of SARS-CoV-2 Positive Patients for the Prevention of Severe COVID-19 Disease.",TERMINATED,,PHASE3,148.0,ACTUAL,University of Calgary,,2.0,,"Enrolment was suspended on 22may2020, after Mehra et al (Lancet 2020) then stopped due to lack of Covid19 cases.",f,,,,t,f,f,,,,,,24 months after study close out.,pending.,,YES,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,OTHER,,,,,,,2020,0.0
NCT02426658,,2015-04-22,2020-02-03,,2023-10-05,2015-04-22,2015-04-27,ESTIMATED,2020-03-04,2020-03-18,ACTUAL,,,,2023-10-05,2023-10-12,ACTUAL,2015-05,ACTUAL,2015-05-31,2023-08,2023-08-31,2022-10-07,ACTUAL,2022-10-07,2018-04-19,ACTUAL,2018-04-19,,INTERVENTIONAL,,,Pemetrexed Disodium in Treating Patients With Stage IV Non-small Cell Lung Cancer and ECOG Performance Status 3,A Pilot Study Evaluating Pemetrexed in ECOG Performance Status 3 Patients With Stage IV Non-squamous Non-small Cell Lung Cancer,COMPLETED,,PHASE2,16.0,ACTUAL,Wake Forest University Health Sciences,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,OTHER,,,,,,,2022,1.0
NCT04727229,,2021-01-22,,,2024-02-07,2021-01-22,2021-01-27,ACTUAL,,,,,,,2024-02-07,2024-02-09,ACTUAL,2021-09-23,ACTUAL,2021-09-23,2024-02,2024-02-29,2022-03-10,ACTUAL,2022-03-10,2022-02-10,ACTUAL,2022-02-10,,INTERVENTIONAL,,,Stellate Ganglion Block for Major Depressive Disorder.,Stellate Ganglion Block for Major Depressive Disorder: A Randomized Controlled Pilot Trial,COMPLETED,,PHASE4,10.0,ACTUAL,Unity Health Toronto,,2.0,,,f,,,,,f,f,,,,,,,,,NO,No individual participant data has been planned to be shared with other researchers at this point since this is a feasibility study with only 10 participants.,2024-10-15 10:30:28.70084,2024-10-15 10:30:28.70084,OTHER,,,,,,,2022,1.0
NCT04249037,,2020-01-28,,,2023-11-27,2020-01-28,2020-01-30,ACTUAL,,,,,,,2023-11-27,2023-11-30,ACTUAL,2020-12-15,ACTUAL,2020-12-15,2023-11,2023-11-30,2023-07-01,ACTUAL,2023-07-01,2023-07-01,ACTUAL,2023-07-01,,INTERVENTIONAL,B-HASTE,,Rapid Start vs. Standard Start Antiretroviral Therapy (ART) in HIV,"Prospective Pilot Study of the Efficacy, Safety and Tolerability of Bictegravir-Based HIV ART Same-Day Treatment Evaluations (B-HASTE)",TERMINATED,,PHASE4,10.0,ACTUAL,"University of Colorado, Denver",,2.0,,Insufficient enrollment,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 10:30:28.70084,2024-10-15 10:30:28.70084,OTHER,,,,,,,2023,0.0
NCT04760314,,2021-02-10,2023-07-28,,2023-07-28,2021-02-17,2021-02-18,ACTUAL,2023-07-28,2023-08-23,ACTUAL,,,,2023-07-28,2023-08-23,ACTUAL,2021-03-10,ACTUAL,2021-03-10,2023-07,2023-07-31,2023-02-01,ACTUAL,2023-02-01,2022-07-31,ACTUAL,2022-07-31,,INTERVENTIONAL,ADhere-J,All randomized participants.,A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis,"A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab When Used in Combination With Topical Corticosteroid Treatment in Japanese Patients With Moderate-to-Severe Atopic Dermatitis",COMPLETED,,PHASE3,286.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,t,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,INDUSTRY,,,,,,,2023,1.0
NCT04210310,,2019-12-12,2022-08-04,,2022-09-07,2019-12-23,2019-12-24,ACTUAL,2022-09-07,2022-10-05,ACTUAL,,,,2022-09-07,2022-10-05,ACTUAL,2020-01-15,ACTUAL,2020-01-15,2022-09,2022-09-30,2022-05-10,ACTUAL,2022-05-10,2022-05-10,ACTUAL,2022-05-10,,INTERVENTIONAL,,,High Dose Oxytocin Nasal Spray for Treatment of Tinnitus,"A Pilot, Proof of Concept, Placebo-controlled, Parallel Study of the Effects of High Dose Intranasal Oxytocin for the Treatment of Tinnitus",TERMINATED,,PHASE3,33.0,ACTUAL,NYU Langone Health,Study was prematurely terminated due to PI/Study Team departure from institution. No outcome measure data collected or analyzed. All participants lost to follow-up.,2.0,,PI departure from the institution.,f,,,,t,t,f,,,t,,,Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.,"The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to Lawrence.newman@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.",,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).",2024-10-15 10:30:28.70084,2024-10-15 10:30:28.70084,OTHER,,,,,,,2022,0.0
NCT02677701,,2016-01-29,2021-02-09,,2021-06-03,2016-02-04,2016-02-09,ESTIMATED,2021-02-09,2021-03-01,ACTUAL,,,,2021-06-03,2021-06-28,ACTUAL,2016-10-21,ACTUAL,2016-10-21,2021-06,2021-06-30,2020-02-13,ACTUAL,2020-02-13,2020-02-13,ACTUAL,2020-02-13,,INTERVENTIONAL,TEACH,Modified intent-to-treat population (m-ITT) defined as all randomized participants who received at least one dose of study drug.,Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF),"TEACH Trial: Testing the Effect of Adding CHronic Azithromycin to Inhaled Tobramycin. A Randomized, Placebo-controlled, Double-blinded Trial of Azithromycin 500mg Thrice Weekly in Combination With Inhaled Tobramycin",COMPLETED,,PHASE4,119.0,ACTUAL,Seattle Children's Hospital,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,OTHER,,,,,,,2020,1.0
NCT05431582,,2022-06-20,,,2023-06-14,2022-06-20,2022-06-24,ACTUAL,,,,,,,2023-06-14,2023-06-15,ACTUAL,2022-12-14,ACTUAL,2022-12-14,2023-02,2023-02-28,2022-12-14,ACTUAL,2022-12-14,2022-12-14,ACTUAL,2022-12-14,,INTERVENTIONAL,,,Phase I Study of ZN-c3 and Bevacizumab ± Pembrolizumab in Metastatic CCNE1 Amplified and TP53 Mutant Solid Tumors,Phase I Study of ZN-c3 and Bevacizumab ± Pembrolizumab in Metastatic CCNE1 Amplified and TP53 Mutant Solid Tumors,WITHDRAWN,,PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,No participants enrolled,,,,,t,t,f,,,,,,,,,,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,OTHER,,,,,,,2022,0.0
NCT02269917,,2014-10-17,2018-08-14,2018-02-08,2021-11-25,2014-10-17,2014-10-21,ESTIMATED,2018-11-08,2018-11-09,ACTUAL,2018-02-08,2018-02-12,ACTUAL,2021-11-25,2021-12-09,ACTUAL,2015-03,ACTUAL,2015-03-31,2021-11,2021-11-30,2020-10,ACTUAL,2020-10-31,2017-02,ACTUAL,2017-02-28,,INTERVENTIONAL,,Intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least 1 dose of study treatment.,"Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants","A Phase 3, Randomized, Active-controlled, Open-label Study to Evaluate the Efficacy, Safety and Tolerability of Switching to a Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once-daily Single-tablet Regimen Versus Continuing the Current Regimen Consisting of a Boosted Protease Inhibitor (bPI) Combined With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in Virologically-suppressed, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects",COMPLETED,,PHASE3,1149.0,ACTUAL,Janssen R&D Ireland,The limitation of the study was the open-label design.,2.0,,,f,,,,t,,f,,,,,,,,,,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,INDUSTRY,,,,,,,2020,1.0
NCT02811133,,2016-06-16,,,2023-10-04,2016-06-20,2016-06-23,ESTIMATED,,,,,,,2023-10-04,2023-10-06,ACTUAL,2023-08,ESTIMATED,2023-08-31,2023-10,2023-10-31,2023-10-04,ACTUAL,2023-10-04,2023-10-04,ACTUAL,2023-10-04,,INTERVENTIONAL,,,Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder,Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Pittsburgh,,1.0,,Funding terminated,f,,,,t,t,f,,,,,,"Data will be shared, as deemed appropriate, starting 6 months after completion of the study for a period of 5 years.",Biomedical researcher involved in research activity in a related field and from an established research institution.,,YES,"Upon request from other researchers, we will make available de-identified subject data, as appropriate.",2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,OTHER,,,,,,,2023,0.0
NCT02974257,,2016-11-23,,,2022-08-05,2016-11-23,2016-11-28,ESTIMATED,,,,,,,2022-08-05,2022-08-09,ACTUAL,2017-05-01,ACTUAL,2017-05-01,2022-08,2022-08-31,2022-08-01,ACTUAL,2022-08-01,2022-02-07,ACTUAL,2022-02-07,,INTERVENTIONAL,,,Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest,"Randomized, Double-blind, Placebo-controlled Trial of the Effect of Thiamine on Oxygen Consumption After In-hospital Cardiac Arrest.",TERMINATED,,PHASE2,36.0,ACTUAL,Beth Israel Deaconess Medical Center,,2.0,,Study stopped early after consultation with DSMB,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,OTHER,,,,,,,2022,0.0
NCT04892043,,2021-04-28,,,2024-02-21,2021-05-13,2021-05-19,ACTUAL,,,,,,,2024-02-21,2024-02-23,ACTUAL,2021-08-19,ACTUAL,2021-08-19,2024-02,2024-02-29,2023-11-02,ACTUAL,2023-11-02,2023-11-02,ACTUAL,2023-11-02,,INTERVENTIONAL,,,"Study of SQZ-AAC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors","A Phase 1, Multicenter, Open-Label Study of SQZ-AAC-HPV as Monotherapy and in Combination With Immune Checkpoint Inhibitors in HLA-A*02+ Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors",TERMINATED,,PHASE1,5.0,ACTUAL,SQZ Biotechnologies,,2.0,,Corporate Decision,f,,,,t,t,f,,,,,,,,,,,2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,INDUSTRY,,,,,,,2023,0.0
NCT01402284,,2011-07-23,2017-03-01,,2021-02-10,2011-07-23,2011-07-26,ESTIMATED,2017-04-14,2017-05-16,ACTUAL,,,,2021-02-10,2021-03-02,ACTUAL,2011-07-21,ACTUAL,2011-07-21,2021-02,2021-02-28,2020-09-24,ACTUAL,2020-09-24,2016-07-10,ACTUAL,2016-07-10,,INTERVENTIONAL,,,"Carfilzomib, Lenalidomide, and Dexamethasone in New Multiple Myeloma Patients","Carfilzomib, Lenalidomide, and Dexamethasone in Newly Diagnosed Multiple Myeloma: Clinical and Correlative Phase II Study",COMPLETED,,PHASE2,45.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,NIH,,,,,,,2020,1.0
NCT02538666,,2015-08-26,2019-10-01,,2022-12-13,2015-09-01,2015-09-02,ESTIMATED,2019-10-01,2019-10-22,ACTUAL,,,,2022-12-13,2023-01-05,ACTUAL,2015-10-13,ACTUAL,2015-10-13,2022-12,2022-12-31,2021-11-11,ACTUAL,2021-11-11,2018-10-01,ACTUAL,2018-10-01,,INTERVENTIONAL,CheckMate 451,All Randomized Participants,"An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy","A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)",COMPLETED,,PHASE3,907.0,ACTUAL,Bristol-Myers Squibb,,3.0,,,t,,,,t,t,f,,,,,,,,,,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,INDUSTRY,,NCT03126643,APPROVED_FOR_MARKETING,,,,2021,1.0
NCT04336982,,2020-03-26,,,2024-05-30,2020-04-06,2020-04-07,ACTUAL,,,,,,,2024-05-30,2024-05-31,ACTUAL,2020-08-05,ACTUAL,2020-08-05,2024-05,2024-05-31,2024-04-05,ACTUAL,2024-04-05,2023-10-25,ACTUAL,2023-10-25,,INTERVENTIONAL,,,A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia,An Exploratory Phase 1b Open-label Multi-arm Trial to Evaluate the Safety and Efficacy of CC-90009 in Combination With Anti-Leukemia Agents in Subjects With Acute Myeloid Leukemia,TERMINATED,,PHASE1,22.0,ACTUAL,Celgene,,2.0,,Business objectives have changed.,f,,,,f,t,f,,,,,,See Plan Description,See Plan Description,https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,INDUSTRY,,,,,,,2024,0.0
NCT03844633,,2019-02-14,2024-03-17,,2024-04-11,2019-02-14,2019-02-18,ACTUAL,2024-04-11,2024-05-07,ACTUAL,,,,2024-04-11,2024-05-07,ACTUAL,2019-03-21,ACTUAL,2019-03-21,2024-04,2024-04-30,2022-04-18,ACTUAL,2022-04-18,2021-05-26,ACTUAL,2021-05-26,,INTERVENTIONAL,,,Postpartum Family Planning,Initiation of Injectable Contraception Immediately Postpartum Among Breastfeeding Women,TERMINATED,,PHASE4,49.0,ACTUAL,Ohio State University,,3.0,,"Because of insufficient enrollment, we closed the RCT and replaced it with an observational design",f,,,,t,t,f,,,t,,,"Once the primary results are accepted for publication in a peer-reviewed journal, we will make full, de-identified datasets available to individual investigators formally requesting this access.","The request should specify the data variables needed, the plan for their analysis, the individuals who will have access to the data, and the plan for destroying the data once the planned analysis is completed. To protect the integrity of the data, the requestor must submit proof of IRB approval or exemption from their institution before we will release the data. The shared data will not contain any individual participant identifiers. The data will be sent in a secured encrypted data file, and the requestors will be responsible for notifying the project PIs upon completion of analysis and specifying the manner in which the data were destroyed. Any presentations, abstracts, or publications will be required to include an acknowledgement of the trial funding source.",,YES,"We will welcome collaboration with others who could make use of the study materials and study datasets resulting from the project. Once the primary results are accepted for publication in a peer-reviewed journal, we will make full, de-identified datasets available to individual investigators formally requesting this access.",2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,OTHER,,,,,,,2022,0.0
NCT02689336,,2016-02-12,,,2019-09-05,2016-02-18,2016-02-23,ESTIMATED,,,,,,,2019-09-05,2019-09-09,ACTUAL,2016-08-06,ACTUAL,2016-08-06,2019-09,2019-09-30,2020-05-31,ESTIMATED,2020-05-31,2019-11-30,ESTIMATED,2019-11-30,,INTERVENTIONAL,,,Erlotinib in Combination With Temozolomide in Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors,Phase 2 Clinical Trial Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors With the Genomically-Targeted Agent Erlotinib in Combination With Temozolomide,WITHDRAWN,,PHASE2,0.0,ACTUAL,Washington University School of Medicine,,1.0,,Could not recruit any participants,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,OTHER,,,,,,,2020,0.0
NCT03179995,,2017-06-06,2022-04-06,,2024-01-19,2017-06-06,2017-06-07,ACTUAL,2022-05-04,2022-05-26,ACTUAL,,,,2024-01-19,2024-02-14,ACTUAL,2017-07-07,ACTUAL,2017-07-07,2024-01,2024-01-31,2020-02-12,ACTUAL,2020-02-12,2020-02-12,ACTUAL,2020-02-12,,INTERVENTIONAL,,,Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy,GI-072: Randomized Controlled Trial of the Use of Octreotide to Enhance Liver Recovery After Major Hepatectomy,TERMINATED,,PHASE2,23.0,ACTUAL,Fox Chase Cancer Center,,2.0,,Grantor closed study,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,OTHER,,,,,,,2020,0.0
NCT03889158,,2019-03-20,2021-04-28,,2021-10-15,2019-03-21,2019-03-26,ACTUAL,2021-10-15,2021-11-12,ACTUAL,,,,2021-10-15,2021-11-12,ACTUAL,2019-03-25,ACTUAL,2019-03-25,2021-10,2021-10-31,2020-03-13,ACTUAL,2020-03-13,2020-03-13,ACTUAL,2020-03-13,,INTERVENTIONAL,,Analysis only completed on individuals with complete data.,Effect of Age and Fitness on Vascular Function and Oxidative Stress During Acute Inflammation,Effect of Age and Fitness on Vascular Function and Oxidative Stress During Acute Inflammation,TERMINATED,,PHASE4,35.0,ACTUAL,University of Illinois at Chicago,,2.0,,COVID-19,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,OTHER,,,,,,,2020,0.0
NCT04052269,,2019-08-05,,,2021-01-21,2019-08-08,2019-08-09,ACTUAL,,,,,,,2021-01-21,2021-01-25,ACTUAL,2019-06-21,ACTUAL,2019-06-21,2021-01,2021-01-31,2022-10-30,ESTIMATED,2022-10-30,2021-10-30,ESTIMATED,2021-10-30,,INTERVENTIONAL,PhiGS,,Phosphodiesterase Inhibitors in Glaucoma Study (PhiGS),A Pilot Study to Investigate the Effect of Phosphodiesterase Inhibitors on Chorioretinal Blood Flow Using Optical Coherence Tomography Angiography.,SUSPENDED,,PHASE3,30.0,ESTIMATED,Imperial College London,,2.0,,suspended due to COVID,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,OTHER,,,,,,,2022,0.0
NCT03014219,,2017-01-04,,,2017-07-03,2017-01-05,2017-01-09,ESTIMATED,,,,,,,2017-07-03,2017-07-06,ACTUAL,2017-07,ESTIMATED,2017-07-31,2017-07,2017-07-31,2020-07,ESTIMATED,2020-07-31,2019-07,ESTIMATED,2019-07-31,,INTERVENTIONAL,,,Phase 1 Crohn's Pediatric Sub-study of MSC AFP,A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease: Pediatric Sub-study,WITHDRAWN,,PHASE1,0.0,ACTUAL,Mayo Clinic,,1.0,,FDA approval was not obtained until adult trial completes accrual,f,,,,f,t,f,,,,,,,,,,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,OTHER,,,,,,,2020,0.0
NCT03068247,,2017-02-24,,,2023-04-20,2017-02-24,2017-03-01,ACTUAL,,,,,,,2023-04-20,2023-04-24,ACTUAL,2021-11,ESTIMATED,2021-11-30,2021-04,2021-04-30,2023-05,ESTIMATED,2023-05-31,2023-05,ESTIMATED,2023-05-31,,INTERVENTIONAL,,,Neurobiology of Treatment Responses in MDD,Neurobiology of Non-Specific and Specific Treatment Responses in Major Depression,WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Utah,,2.0,,Institution was unable to manufacture radiotracer that was central to the protocol. Study transferred to another institution.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,OTHER,,,,,,,2023,0.0
NCT03567291,,2018-06-12,2021-01-21,,2021-11-05,2018-06-12,2018-06-25,ACTUAL,2021-02-25,2021-03-23,ACTUAL,,,,2021-11-05,2021-11-09,ACTUAL,2018-05-25,ACTUAL,2018-05-25,2021-11,2021-11-30,2020-05-15,ACTUAL,2020-05-15,2020-05-15,ACTUAL,2020-05-15,,INTERVENTIONAL,ARTISTS,Intent-to-treat (ITT) analysis set included all enrolled participants.,Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents,"An Open-Label, Long-Term Safety Study Including a Double-Blind, Placebo-Controlled, Randomized Withdrawal Period of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents",TERMINATED,,PHASE3,228.0,ACTUAL,"Teva Branded Pharmaceutical Products R&D, Inc.",,3.0,,The parent trials did not meet the primary endpoints of reduction in motor and phonic tics.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,INDUSTRY,,,,,,,2020,0.0
NCT03011307,,2016-12-16,2022-08-01,,2022-11-01,2017-01-03,2017-01-05,ESTIMATED,2022-11-01,2022-11-23,ACTUAL,,,,2022-11-01,2022-11-23,ACTUAL,2017-01-12,ACTUAL,2017-01-12,2022-09,2022-09-30,2021-08-11,ACTUAL,2021-08-11,2020-10-23,ACTUAL,2020-10-23,,INTERVENTIONAL,,,Efficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery,Efficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery,TERMINATED,,PHASE2,126.0,ACTUAL,Wake Forest University Health Sciences,The trial was terminated early because of depletion of funding. Power analysis was based on 120 subjects and only 90 were studied before termination of funding .,2.0,,"Cessation of funding period prior to completion, due to slow recruitment during the pandemic.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,OTHER,,,,,,,2021,0.0
NCT05256277,,2022-02-08,,,2023-05-11,2022-02-21,2022-02-25,ACTUAL,,,,,,,2023-05-11,2023-05-16,ACTUAL,2021-12-28,ACTUAL,2021-12-28,2023-05,2023-05-31,2023-04-03,ACTUAL,2023-04-03,2022-08-28,ACTUAL,2022-08-28,,INTERVENTIONAL,,,NK Cell Therapy for AML,A Phase 1 Study of Evaluating Preliminary Safety and Efficacy of CT101a in the Treatment of Relapsed or Refractory (r/r) AML Patients,TERMINATED,,PHASE1,3.0,ACTUAL,Zhejiang University,,1.0,,A new study is planed to replace the current study due to IP upgrade,f,,,,t,f,f,,,,,,,,,,,2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,OTHER,,,,,,,2023,0.0
NCT04030052,,2019-07-21,,,2024-01-03,2019-07-21,2019-07-23,ACTUAL,,,,,,,2024-01-03,2024-01-05,ACTUAL,2022-02-17,ACTUAL,2022-02-17,2024-01,2024-01-31,2023-01-19,ACTUAL,2023-01-19,2023-01-19,ACTUAL,2023-01-19,,INTERVENTIONAL,,,Emicizumab PUPs and Nuwiq ITI Study,Emicizumab PUPs and Nuwiq ITI Study,WITHDRAWN,,PHASE3,0.0,ACTUAL,Emory University,,2.0,,The Emi PUPs and Nuwiq ITI study has been closed due to slow enrollment and study site startup.,f,,,,t,t,f,,,f,,,Data will become available beginning 9 months and ending 36 months after publication,"Data will be shared with investigators/researchers involved in the study approved by the steering committee following verification of sound science for the purpose of achieving aims of the study, meta-analysis and for sound scientific evaluation deemed by the steering committee. Proposal may be submitted up to 36 months following publication and can be accessed following steering committee approval directed to Traci Leong (tleong@emory.edu), the statistician.",,YES,"All of the individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures and appendices) will be shared.",2024-10-16 07:21:36.449111,2024-10-16 07:21:36.449111,OTHER,,,,,,,2023,0.0
NCT04005209,,2019-06-28,,,2021-12-29,2019-07-01,2019-07-02,ACTUAL,,,,,,,2021-12-29,2022-01-14,ACTUAL,2022-01,ESTIMATED,2022-01-31,2021-12,2021-12-31,2022-11,ESTIMATED,2022-11-30,2022-11,ESTIMATED,2022-11-30,,INTERVENTIONAL,,,Ketamine Infusion for Sickle Cell Pain Crisis,"Early Low-dose Ketamine Infusion Versus Usual Care for Sickle Cell Pain Crisis: a Randomized, Prospective Study.",WITHDRAWN,,PHASE4,0.0,ACTUAL,Duke University,,2.0,,Decided not to open study,f,,,,,t,f,,,t,,,,,,NO,,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,OTHER,,,,,,,2022,0.0
NCT04527354,,2020-08-24,,,2021-04-02,2020-08-24,2020-08-26,ACTUAL,,,,,,,2021-04-02,2021-04-05,ACTUAL,2020-09-01,ACTUAL,2020-09-01,2021-03,2021-03-31,2021-02-10,ACTUAL,2021-02-10,2021-02-10,ACTUAL,2021-02-10,,INTERVENTIONAL,,,Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia,"Multicenter, Randomized, Double-blind, Placebo-controlled Pilot Study of Treamid Efficacy and Safety in the Rehabilitation of Patients After COVID-19 Pneumonia",COMPLETED,,PHASE2,60.0,ACTUAL,PHARMENTERPRISES LLC,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,INDUSTRY,,,,,,,2021,1.0
NCT04971512,,2021-07-12,,,2022-02-02,2021-07-12,2021-07-21,ACTUAL,,,,,,,2022-02-02,2022-02-14,ACTUAL,2021-08-02,ACTUAL,2021-08-02,2022-02,2022-02-28,2021-12-20,ACTUAL,2021-12-20,2021-12-20,ACTUAL,2021-12-20,,INTERVENTIONAL,,,A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION.,"A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of EDP-721 in Healthy Subjects (Part 1) and the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of EDP-721 in Combination With EDP-514 in Patients With Chronic Hepatitis B Virus Infection (Part 2)",TERMINATED,,PHASE1,26.0,ACTUAL,"Enanta Pharmaceuticals, Inc",,6.0,,Due to adverse safety signals in Part 1 (HV),f,,,,,t,f,,,t,,,,,,,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,INDUSTRY,,,,,,,2021,0.0
NCT03623984,,2018-08-07,,,2023-09-06,2018-08-07,2018-08-09,ACTUAL,,,,,,,2023-09-06,2023-09-11,ACTUAL,2019-06-07,ACTUAL,2019-06-07,2023-09,2023-09-30,2023-06-07,ESTIMATED,2023-06-07,2022-06-07,ACTUAL,2022-06-07,,INTERVENTIONAL,,,Molecular-Guided Surgery for Pancreatic and GI Neuroendocrine Cancers,Molecular-Guided Surgery for Pancreatic and Gastrointestinal Neuroendocrine Cancers,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Alabama at Birmingham,,1.0,,no partipants,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,OTHER,,,,,,,2023,0.0
NCT03097328,,2017-03-15,2022-01-12,,2024-04-24,2017-03-27,2017-03-31,ACTUAL,2022-02-03,2022-02-24,ACTUAL,,,,2024-04-24,2024-04-29,ACTUAL,2017-08-01,ACTUAL,2017-08-01,2024-04,2024-04-30,2024-04-24,ACTUAL,2024-04-24,2021-07-20,ACTUAL,2021-07-20,,INTERVENTIONAL,,Baseline data was assessed in 38 eligible and treated patients. 1 patient who was deemed as ineligible and did not receive treatment was excluded from baseline analysis.,Study of TAK-228 In Patients With Previously Treated Metastatic Renal Cell Carcinoma,A Phase II Study of TAK-228 In Patients With Previously Treated Metastatic Renal Cell Carcinoma,COMPLETED,,PHASE2,39.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,OTHER,,,,,,,2024,0.0
NCT04626947,,2020-09-29,,,2024-06-05,2020-11-06,2020-11-13,ACTUAL,,,,,,,2024-06-05,2024-06-07,ACTUAL,2021-10-30,ACTUAL,2021-10-30,2024-06,2024-06-30,2024-05-31,ACTUAL,2024-05-31,2024-04-24,ACTUAL,2024-04-24,,INTERVENTIONAL,,,Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).,Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).,TERMINATED,,PHASE4,19.0,ACTUAL,University of Pittsburgh,,1.0,,Sponsor's decision,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,OTHER,,,,,,,2024,0.0
NCT05238896,,2022-01-04,,,2023-11-14,2022-02-09,2022-02-14,ACTUAL,,,,,,,2023-11-14,2023-11-18,ACTUAL,2022-06-27,ACTUAL,2022-06-27,2023-11,2023-11-30,2023-03-31,ACTUAL,2023-03-31,2023-02-23,ACTUAL,2023-02-23,,INTERVENTIONAL,BARICENTRE,,BARIcitinib Cognitive Emotional and Neural signaTuRE,BARIcitinib Cognitive Emotional and Neural signaTuRE (BARICENTRE),TERMINATED,,PHASE4,5.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,Difficulties of inclusion in the study following expiry of the experimental treatment. The time required to supply the study treatment is too long to obtain conclusive results at the end of the study.,f,,,,f,f,f,,,,,,Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor,Researchers who provide a methodological sound proposal.,,YES,"Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.~Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.",2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,OTHER,,,,,,,2023,0.0
NCT04875975,,2021-05-03,,,2024-06-27,2021-05-03,2021-05-06,ACTUAL,,,,,,,2024-06-27,2024-06-28,ACTUAL,2021-09-27,ACTUAL,2021-09-27,2024-06,2024-06-30,2024-04-26,ACTUAL,2024-04-26,2024-03-08,ACTUAL,2024-03-08,,INTERVENTIONAL,,,"A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis","A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis",TERMINATED,,PHASE2,12.0,ACTUAL,UCB Pharma,,2.0,,"The study stopped prematurely due to enrolment challenges, the termination was not linked to any safety issues.",f,,,,t,t,f,,,f,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",https://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,INDUSTRY,,,,,,,2024,0.0
NCT04053543,,2019-07-19,,,2020-08-24,2019-08-08,2019-08-12,ACTUAL,,,,,,,2020-08-24,2020-08-26,ACTUAL,2019-08-09,ACTUAL,2019-08-09,2020-08,2020-08-31,2020-08-12,ACTUAL,2020-08-12,2020-08-12,ACTUAL,2020-08-12,,INTERVENTIONAL,,,CXA-10 Study in Subjects With Pulmonary Arterial Hypertension,"A Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects With Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301",TERMINATED,,PHASE2,33.0,ACTUAL,"Complexa, Inc.",,1.0,,LOE,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,INDUSTRY,,,,,,,2020,0.0
NCT02336906,,2015-01-01,,,2018-04-09,2015-01-08,2015-01-13,ESTIMATED,,,,,,,2018-04-09,2018-04-11,ACTUAL,2020-01,ESTIMATED,2020-01-31,2018-04,2018-04-30,2020-12,ESTIMATED,2020-12-31,2020-07,ESTIMATED,2020-07-31,,INTERVENTIONAL,,,Urotherapy vs. Urotherapy With Constipation Treatment for Children With Lower Urinary Tract Dysfunction,"A Controlled Randomized, Physician Blinded Study to Assess Isolated Uro-therapy vs. Urotherapy With Constipation Treatment for Patients With Lower Urinary Tract Dysfunction (LUTD) Not Meeting ROME-III Constipation Criteria",WITHDRAWN,,PHASE4,0.0,ACTUAL,Rabin Medical Center,,2.0,,Changes in departmental staff have led to a cut in research alotments.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,OTHER,,,,,,,2020,0.0
NCT02141282,,2014-05-12,2022-11-18,,2022-11-18,2014-05-15,2014-05-19,ESTIMATED,2022-11-18,2022-12-19,ACTUAL,,,,2022-11-18,2022-12-19,ACTUAL,2014-09-10,ACTUAL,2014-09-10,2022-11,2022-11-30,2021-12-22,ACTUAL,2021-12-22,2021-12-22,ACTUAL,2021-12-22,,INTERVENTIONAL,,All treated participants,A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy,A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy,COMPLETED,,PHASE2,127.0,ACTUAL,AbbVie,,4.0,,,t,,,,f,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,INDUSTRY,,NCT03123029,AVAILABLE,,,,2021,1.0
NCT03645408,,2018-08-21,2021-12-08,,2022-01-14,2018-08-21,2018-08-24,ACTUAL,2022-01-14,2022-02-09,ACTUAL,,,,2022-01-14,2022-02-09,ACTUAL,2019-05-02,ACTUAL,2019-05-02,2022-01,2022-01-31,2021-07-01,ACTUAL,2021-07-01,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,,,"The Effects of Exenatide, a GLP-1 Agonist, on Alcohol Self-Administration in Heavy Drinkers","The Effects of Exenatide, a GLP-1 Agonist, on Alcohol Self-Administration in Heavy Drinkers",TERMINATED,,PHASE1,8.0,ACTUAL,Boston Medical Center,The small sample size reflects the early termination of the research which was halted due to Covid 19 precautions.,2.0,,Due to COVID-19 hospital-wide policies halting recruitment,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,OTHER,,,,,,,2021,0.0
NCT03104335,,2017-04-02,,,2020-05-15,2017-04-03,2017-04-07,ACTUAL,,,,,,,2020-05-15,2020-05-19,ACTUAL,2017-04-01,ACTUAL,2017-04-01,2020-05,2020-05-31,2020-03-01,ACTUAL,2020-03-01,2019-06-30,ACTUAL,2019-06-30,,INTERVENTIONAL,,,"Apatinib for Advanced Soft Tissue Sarcoma Patients: a Phase 2, Multicenter Trial","Apatinib for Advanced Soft Tissue Sarcoma Patients After Failure of Traditional Therapy: an One-armed, Phase 2, Open-label, Multicenter Prospective Trial",WITHDRAWN,,PHASE2,0.0,ACTUAL,Peking University People's Hospital,,1.0,,Not enough patients,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,OTHER,,,,,,,2020,0.0
NCT03969641,,2019-05-28,2022-09-21,,2023-01-09,2019-05-28,2019-05-31,ACTUAL,2022-12-12,2022-12-27,ACTUAL,,,,2023-01-09,2023-01-11,ACTUAL,2019-09-05,ACTUAL,2019-09-05,2023-01,2023-01-31,2021-09-29,ACTUAL,2021-09-29,2021-09-29,ACTUAL,2021-09-29,,INTERVENTIONAL,,Participants who received study product.,Safety of RIV4 Versus IIV4 in Pregnant Women,"A Prospective, Randomized, Clinical Trial to Compare Adverse Birth Outcomes in Pregnant Women Receiving Quadrivalent Recombinant Influenza Vaccine (RIV4) Versus Quadrivalent Inactivated Influenza Vaccine (IIV4)",COMPLETED,,PHASE4,384.0,ACTUAL,Duke University,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,OTHER,,,,,,,2021,1.0
NCT02495077,,2015-07-06,2022-06-14,,2022-07-19,2015-07-08,2015-07-13,ESTIMATED,2022-07-19,2022-08-16,ACTUAL,,,,2022-07-19,2022-08-16,ACTUAL,2015-11-02,ACTUAL,2015-11-02,2022-07,2022-07-31,2021-07-23,ACTUAL,2021-07-23,2021-07-23,ACTUAL,2021-07-23,,INTERVENTIONAL,,Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion,Effects of Inhibiting Early Inflammation in Kidney Transplant Patients,Randomized Controlled Trial of Infliximab (Remicade®) Induction Therapy for Deceased Donor Kidney Transplant Recipients (CTOT-19),COMPLETED,,PHASE2,290.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,NIH,,,,,,,2021,1.0
NCT04346628,,2020-04-10,2022-04-14,,2022-07-06,2020-04-14,2020-04-15,ACTUAL,2022-04-14,2022-04-21,ACTUAL,,,,2022-07-06,2022-07-13,ACTUAL,2020-07-12,ACTUAL,2020-07-12,2022-07,2022-07-31,2021-04-16,ACTUAL,2021-04-16,2021-04-16,ACTUAL,2021-04-16,,INTERVENTIONAL,,"Baseline characteristics were assessed for the symptomatic modified ITT (smITT) Analysis Set (participants who reported at least one symptom other than mild cough, mild fatigue, or decreased taste/smell at baseline), and for the modified ITT (mITT) Analysis Set (participants who were symptomatic with positive RT-PCR result at baseline).",Oral Favipiravir Compared to Placebo in Subjects With Mild COVID-19,"A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Favipiravir Compared to Standard Supportive Care in Subjects With Mild or Asymptomatic COVID-19",COMPLETED,,PHASE2,149.0,ACTUAL,Stanford University,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,No current plan to share individual participant data (IPD).,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,OTHER,,,,,,,2021,1.0
NCT03865407,,2019-03-05,2021-05-04,,2021-05-04,2019-03-05,2019-03-06,ACTUAL,2021-05-04,2021-05-27,ACTUAL,,,,2021-05-04,2021-05-27,ACTUAL,2019-03-10,ACTUAL,2019-03-10,2021-05,2021-05-31,2020-10-07,ACTUAL,2020-10-07,2020-10-07,ACTUAL,2020-10-07,,INTERVENTIONAL,,,Uric Acid Reduction as a Novel Treatment for Pediatric Chronic Kidney Disease,Uric Acid Reduction as a Novel Treatment for Pediatric Chronic Kidney Disease,TERMINATED,,PHASE2,17.0,ACTUAL,Virginia Commonwealth University,,2.0,,inability to achieve recruitment goals at a single center and given the current pandemic conditions,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,OTHER,,,,,,,2020,0.0
NCT03161678,,2017-05-18,2024-01-17,,2024-05-03,2017-05-18,2017-05-22,ACTUAL,2024-05-03,2024-05-06,ACTUAL,,,,2024-05-03,2024-05-06,ACTUAL,2017-08-22,ACTUAL,2017-08-22,2024-05,2024-05-31,2022-12-12,ACTUAL,2022-12-12,2022-12-12,ACTUAL,2022-12-12,,INTERVENTIONAL,,,CES1 Crossover Trial of Clopidogrel and Ticagrelor,Impact of Genetic Variation in CES1 on Antiplatelet Therapy,COMPLETED,,PHASE4,111.0,ACTUAL,"University of Maryland, Baltimore",,3.0,,,f,,,,f,t,f,,,t,,,,,,YES,"It is possible that deidentified data will be deposited into large public databases as per NIH data sharing policies (e.g. database of Genotypes and Phenotypes \[dbGAP\], Pharmacogenomics Knowledgebase \[PharmGKB\]). Data to be shared would include, but not limited to, anthropometric data, study outcome data, and relevant covariate data used in statistical models of association. It is anticipated that data would be available after the completion of the trial. The data will be obtained from the participants and the study-related research procedures.",2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,OTHER,,,,,,,2022,1.0
NCT01390948,,2011-07-07,2016-09-01,,2020-07-23,2011-07-07,2011-07-11,ESTIMATED,2017-04-27,2017-08-04,ACTUAL,,,,2020-07-23,2020-08-06,ACTUAL,2011-10-18,ACTUAL,2011-10-18,2020-07,2020-07-31,2020-01-29,ACTUAL,2020-01-29,2016-02-05,ACTUAL,2016-02-05,,INTERVENTIONAL,,,A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma,"A Phase II Open-Label, Randomized, Multi-Centre Comparative Study Of Bevacizumab-Based Therapy In Paediatric Patients With Newly Diagnosed Supratentorial, Infratentorial Cerebellar, or Peduncular High-Grade Glioma",COMPLETED,,PHASE2,124.0,ACTUAL,Hoffmann-La Roche,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,INDUSTRY,,,,,,,2020,1.0
NCT05392127,,2022-05-23,,,2022-12-21,2022-05-23,2022-05-26,ACTUAL,,,,,,,2022-12-21,2022-12-22,ACTUAL,2022-07-15,ACTUAL,2022-07-15,2022-12,2022-12-31,2022-08-18,ACTUAL,2022-08-18,2022-08-18,ACTUAL,2022-08-18,,INTERVENTIONAL,,,A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers,"A Single-center, Open-label, Single-arm, Fixed-sequence Study to Evaluate the Pharmacokinetic Effects of SHR0302 Tablets on Substrates of CYP3A4, CYP2C8, CYP2C9, CYP2C19 in Healthy Volunteers",COMPLETED,,PHASE1,24.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,1.0,,,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,INDUSTRY,,,,,,,2022,0.0
NCT03066817,,2017-02-23,,,2019-04-02,2017-02-23,2017-02-28,ACTUAL,,,,,,,2019-04-02,2019-04-04,ACTUAL,2017-07-01,ACTUAL,2017-07-01,2019-04,2019-04-30,2020-03,ESTIMATED,2020-03-31,2020-03,ESTIMATED,2020-03-31,,INTERVENTIONAL,,,Vitamin D and Bone Homeostasis in Ortho Polytrauma Patients,A Pilot Study of Role of Vitamin D in Regulation of Bone Homeostasis in Orthopaedic Polytrauma Patients,SUSPENDED,,PHASE1/PHASE2,60.0,ESTIMATED,New York City Health and Hospitals Corporation,,2.0,,Waiting for annual IRB progress report to be reviewed and approved,f,,,,t,t,f,,,t,,,,,,NO,Individual participant data are not planned to be shared.,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,OTHER,,,,,,,2020,0.0
NCT02146547,,2014-05-21,,,2020-08-31,2014-05-21,2014-05-26,ESTIMATED,,,,,,,2020-08-31,2020-09-01,ACTUAL,2015-02,ACTUAL,2015-02-28,2020-08,2020-08-31,2020-08-26,ACTUAL,2020-08-26,2020-08-26,ACTUAL,2020-08-26,,INTERVENTIONAL,EULAST,,European Long-acting Antipsychotics in Schizophrenia Trial,European Long-acting Antipsychotics in Schizophrenia Trial,COMPLETED,,PHASE4,536.0,ACTUAL,UMC Utrecht,,4.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,OTHER,,,,,,,2020,0.0
NCT03238638,,2017-08-01,,,2018-01-02,2017-08-01,2017-08-03,ACTUAL,,,,,,,2018-01-02,2018-01-04,ACTUAL,2018-09,ESTIMATED,2018-09-30,2018-01,2018-01-31,2020-12,ESTIMATED,2020-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,"A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy","A Phase II Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy",WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Chicago,,1.0,,PI did not attempt to open the study.,,,,,t,t,f,,,,,,,,,,,2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,OTHER,,,,,,,2020,0.0
NCT03987620,,2019-06-12,2021-06-30,2021-03-22,2021-08-11,2019-06-12,2019-06-17,ACTUAL,2021-08-11,2021-09-08,ACTUAL,2021-08-11,2021-09-08,ACTUAL,2021-08-11,2021-09-08,ACTUAL,2019-06-07,ACTUAL,2019-06-07,2021-08,2021-08-31,2020-04-29,ACTUAL,2020-04-29,2020-03-29,ACTUAL,2020-03-29,,INTERVENTIONAL,Vanish 306,,Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis,"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (AVVC).",COMPLETED,,PHASE3,455.0,ACTUAL,"Scynexis, Inc.",,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,INDUSTRY,,,,,,,2020,1.0
NCT05160558,,2021-12-07,,,2023-08-03,2021-12-07,2021-12-16,ACTUAL,,,,,,,2023-08-03,2023-08-04,ACTUAL,2022-02-02,ACTUAL,2022-02-02,2023-08,2023-08-31,2023-07-25,ACTUAL,2023-07-25,2023-07-25,ACTUAL,2023-07-25,,INTERVENTIONAL,,,A Pharmacokinetics and Safety Study of BIIB132 in Adults With Spinocerebellar Ataxia 3,"A Phase 1, Blinded, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of BIIB132 Administered Intrathecally to Adults With Spinocerebellar Ataxia 3",TERMINATED,,PHASE1,8.0,ACTUAL,Biogen,,5.0,,Sponsor's Decision,f,,,,f,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,INDUSTRY,,,,,,,2023,0.0
NCT03492463,,2018-04-03,2022-05-31,,2023-01-13,2018-04-03,2018-04-10,ACTUAL,2022-05-31,2022-06-28,ACTUAL,,,,2023-01-13,2023-02-08,ACTUAL,2018-08-06,ACTUAL,2018-08-06,2023-01,2023-01-31,2021-05-31,ACTUAL,2021-05-31,2021-05-31,ACTUAL,2021-05-31,,INTERVENTIONAL,ENDS-Switch,,The Role of Nicotine Dose and Route of Delivery in Affecting Adoption of E-cigarettes and Reducing Exposure to Toxic Combustion Products,The Role of Nicotine Dose and Route of Delivery in Affecting Adoption of E-cigarettes and Reducing Exposure to Toxic Combustion Products,COMPLETED,,PHASE2,94.0,ACTUAL,Duke University,,4.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,OTHER,,,,,,,2021,1.0
NCT03940651,,2019-04-03,,,2021-02-02,2019-05-03,2019-05-07,ACTUAL,,,,,,,2021-02-02,2021-02-05,ACTUAL,2019-09-04,ACTUAL,2019-09-04,2021-02,2021-02-28,2020-09-23,ACTUAL,2020-09-23,2020-09-23,ACTUAL,2020-09-23,,INTERVENTIONAL,,,Cardiac and Renal Biomarkers in Arthroplasty Surgery,Effect of Spinal Versus General Anesthesia on Cardiac and Renal Biomarker Levels in Hip and Knee Arthroplasty Surgery,TERMINATED,,PHASE4,1.0,ACTUAL,Washington University School of Medicine,,2.0,,Funding ended,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,OTHER,,,,,,,2020,0.0
NCT04224740,,2020-01-03,,,2024-03-12,2020-01-08,2020-01-13,ACTUAL,,,,,,,2024-03-12,2024-03-13,ACTUAL,2020-06-15,ACTUAL,2020-06-15,2024-03,2024-03-31,2023-11-13,ACTUAL,2023-11-13,2023-11-13,ACTUAL,2023-11-13,,INTERVENTIONAL,HERCULES,,Pembrolizumab Combined With Cisplatin-based Chemotherapy as First-line Systemic Therapy in Advanced Penile Cancer,A Phase II Trial of Pembrolizumab Combined With Cisplatin-based Chemotherapy as First-line Systemic Therapy in Advanced Penile Cancer,COMPLETED,,PHASE2,37.0,ACTUAL,Latin American Cooperative Oncology Group,,1.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,OTHER,,,,,,,2023,1.0
NCT02584634,,2015-10-21,2022-01-13,,2023-06-21,2015-10-21,2015-10-22,ESTIMATED,2022-01-13,2022-02-09,ACTUAL,,,,2023-06-21,2023-07-07,ACTUAL,2015-12-18,ACTUAL,2015-12-18,2023-06,2023-06-30,2022-07-13,ACTUAL,2022-07-13,2021-02-02,ACTUAL,2021-02-02,,INTERVENTIONAL,,The baseline analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received.,"Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)","A PHASE 1B/2, OPEN-LABEL, DOSE-FINDING STUDY TO EVALUATE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH EITHER CRIZOTINIB OR PF-06463922 IN PATIENTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER",TERMINATED,,PHASE1/PHASE2,43.0,ACTUAL,Pfizer,Enrollment in the study was terminated early based on the changing landscape in treatment options for treatment naïve ALK positive NSCLC. This decision was not due to any safety concerns or regulatory interactions. All participants on active treatment at the time of the early enrollment termination could continue treatment and follow up per the protocol.,2.0,,The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522),f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,INDUSTRY,,,,,,,2022,0.0
NCT01300611,,2011-02-17,,,2020-12-07,2011-02-17,2011-02-21,ESTIMATED,,,,,,,2020-12-07,2020-12-08,ACTUAL,2011-01,,2011-01-31,2020-12,2020-12-31,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,USBTXA127CBT,,TXA127 in Enhancement of Engraftment in Adult Double Cord Blood Transplantation,Phase I Evaluation of the Safety and Efficacy of TXA127 (Angiotensin 1-7) to Enhance Engraftment in Adults Undergoing Double Cord Blood Transplantation,TERMINATED,,PHASE1,20.0,ESTIMATED,Tarix Pharmaceuticals,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 07:26:46.343629,2024-10-16 07:26:46.343629,INDUSTRY,,,,,,,2020,0.0
NCT04264637,,2020-02-10,,,2022-03-10,2020-02-10,2020-02-11,ACTUAL,,,,,,,2022-03-10,2022-03-25,ACTUAL,2020-02-03,ACTUAL,2020-02-03,2022-03,2022-03-31,2021-03-17,ACTUAL,2021-03-17,2021-03-17,ACTUAL,2021-03-17,,INTERVENTIONAL,,,Study to Find Out How Long it Takes Azelastine Hydrochloride 0.15% Nasal Spray to Relieve Symptoms in Patients Suffering From Allergic Rhinitis,"A Randomized, Double-Blind, Placebo Controlled, Crossover Study to Evaluate the Onset of Efficacy of Azelastine Hydrochloride 0.15% Nasal Spray in Allergic Rhinitis Sufferers Following Pollen Exposure in an Environmental Exposure Chamber",COMPLETED,,PHASE3,110.0,ACTUAL,Bayer,,2.0,,,f,,,,f,f,f,,,f,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,INDUSTRY,,,,,,,2021,1.0
NCT03740737,,2018-10-24,2023-08-30,2021-10-20,2023-12-21,2018-11-09,2018-11-14,ACTUAL,2023-12-21,2024-01-18,ACTUAL,,2024-01-18,ACTUAL,2023-12-21,2024-01-18,ACTUAL,2018-10-26,ACTUAL,2018-10-26,2023-08,2023-08-31,2020-11-11,ACTUAL,2020-11-11,2020-11-11,ACTUAL,2020-11-11,,INTERVENTIONAL,RITA-1,The modified intention-to-treat (mITT) analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment.,Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-1),"A Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Trial Investigating the Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Women Aged 18-34 Years Undergoing Assisted Reproductive Technology",COMPLETED,,PHASE3,579.0,ACTUAL,Ferring Pharmaceuticals,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,INDUSTRY,,,,,,,2020,1.0
NCT04502888,,2020-07-31,,,2022-12-06,2020-08-04,2020-08-06,ACTUAL,,,,,,,2022-12-06,2022-12-08,ACTUAL,2020-09-17,ACTUAL,2020-09-17,2022-12,2022-12-31,2022-04-08,ACTUAL,2022-04-08,2022-04-08,ACTUAL,2022-04-08,,INTERVENTIONAL,,,Ph1 Study of SL-172154 Administered Intratumorally in Subjects With Squamous Cell Carcinoma of the Head and Neck or Skin,"Phase 1 Dose Escalation Study of the Agonist Redirected Checkpoint, SL-172154 (SIRPα-Fc-CD40L), Administered Intratumorally in Subjects With Cutaneous Squamous Cell Carcinoma or Squamous Cell Carcinoma of the Head and Neck",TERMINATED,,PHASE1,5.0,ACTUAL,"Shattuck Labs, Inc.",,1.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,INDUSTRY,,,,,,,2022,0.0
NCT02458690,,2015-05-28,2020-08-31,,2023-10-03,2015-05-29,2015-06-01,ESTIMATED,2020-09-21,2020-10-14,ACTUAL,,,,2023-10-03,2023-10-19,ACTUAL,2015-07,ACTUAL,2015-07-31,2023-10,2023-10-31,2021-03,ACTUAL,2021-03-31,2019-08,ACTUAL,2019-08-31,,INTERVENTIONAL,,,eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients,eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients,COMPLETED,,PHASE2,216.0,ACTUAL,Indiana University,,2.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,OTHER,,,,,,,2021,1.0
NCT02577406,,2015-10-14,2022-06-29,,2024-04-25,2015-10-14,2015-10-16,ESTIMATED,2022-08-17,2022-09-10,ACTUAL,,,,2024-04-25,2024-04-30,ACTUAL,2015-12-30,ACTUAL,2015-12-30,2024-04,2024-04-30,2024-03-25,ACTUAL,2024-03-25,2020-03-17,ACTUAL,2020-03-17,,INTERVENTIONAL,IDHENTIFY,,An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation,"A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation",COMPLETED,,PHASE3,319.0,ACTUAL,Celgene,,2.0,,,t,,,,t,,,,,,,,,,,,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,INDUSTRY,,NCT03723057,NO_LONGER_AVAILABLE,,,,2024,1.0
NCT02267863,,2014-10-03,,,2022-08-18,2014-10-16,2014-10-20,ESTIMATED,,,,,,,2022-08-18,2022-08-22,ACTUAL,2014-10,,2014-10-31,2022-08,2022-08-31,2021-09,ACTUAL,2021-09-30,2021-09,ACTUAL,2021-09-30,,INTERVENTIONAL,,,A Study of APTO-253 in Patients With Relapsed or Refractory AML or MDS,"A Phase Ia/b Dose Escalation and Expansion, Multicenter, Open-label, Safety, Pharmacokinetic and Pharmacodynamic Study of APTO-253 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia or High-Risk Myelodysplasia",TERMINATED,,PHASE1,21.0,ACTUAL,Aptose Biosciences Inc.,,1.0,,Drug manufacturing process and procedure review,f,,,,t,,,,,,,,,,,,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,INDUSTRY,,,,,,,2021,0.0
NCT04629339,,2020-11-10,,,2024-04-18,2020-11-10,2020-11-16,ACTUAL,,,,,,,2024-04-18,2024-04-22,ACTUAL,2021-09-02,ACTUAL,2021-09-02,2024-04,2024-04-30,2024-03-26,ACTUAL,2024-03-26,2024-03-26,ACTUAL,2024-03-26,,INTERVENTIONAL,,,Study of INCB086550 in Select Solid Tumors,A Phase 2 Study of INCB086550 (Oral PD-L1 Inhibitor) in Participants Who Are Immune Checkpoint Inhibitor-Naïve With Selected Solid Tumors,TERMINATED,,PHASE2,16.0,ACTUAL,Incyte Corporation,,1.0,,Strategic business decision to terminate the study effective immediately. This is due to a company decision to prioritize another oral PD-L1 inhibitor with a more favorable profile.,f,,,,t,t,f,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,INDUSTRY,,,,,,,2024,0.0
NCT05475821,,2022-07-25,,,2022-10-25,2022-07-26,2022-07-27,ACTUAL,,,,,,,2022-10-25,2022-10-27,ACTUAL,2022-07-25,ACTUAL,2022-07-25,2022-10,2022-10-31,2022-09-26,ACTUAL,2022-09-26,2022-09-26,ACTUAL,2022-09-26,,INTERVENTIONAL,,,Study to Assess Adverse Events and How Oral ABBV-990 Moves Through the Body of Adult Healthy Participants,"A First in Human, Single Ascending Dose Study for the Assessment of Pharmacokinetics, Safety and Tolerability of ABBV-990 in Healthy Male and Female Subjects",TERMINATED,,PHASE1,24.0,ACTUAL,AbbVie,,5.0,,Company decision: re-evaluation of risk vs benefit (based on animal data),f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,INDUSTRY,,,,,,,2022,0.0
NCT05094154,,2021-10-22,2023-10-14,,2023-12-07,2021-10-22,2021-10-26,ACTUAL,2023-12-07,2023-12-22,ACTUAL,,,,2023-12-07,2023-12-22,ACTUAL,2021-11-10,ACTUAL,2021-11-10,2023-12,2023-12-31,2022-10-21,ACTUAL,2022-10-21,2022-10-21,ACTUAL,2022-10-21,,INTERVENTIONAL,ACORN,,Effect of Antibiotic Choice On ReNal Outcomes (ACORN),Effect of Antibiotic Choice On ReNal Outcomes (ACORN),COMPLETED,,PHASE4,2634.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,,f,,,,t,t,f,,,f,,,The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.,Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.,,YES,Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,OTHER,,,,,,,2022,0.0
NCT05388435,,2022-03-15,,,2024-03-31,2022-05-19,2022-05-24,ACTUAL,,,,,,,2024-03-31,2024-04-02,ACTUAL,2022-09-12,ACTUAL,2022-09-12,2024-03,2024-03-31,2024-03-01,ACTUAL,2024-03-01,2024-03-01,ACTUAL,2024-03-01,,INTERVENTIONAL,,,"Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients","A Phase 1/2, Open-Label, Multicenter, Dose-Finding Study of SKL27969 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,17.0,ACTUAL,"SK Life Science, Inc.",,2.0,,The study has been terminated based on portfolio prioritization. No safety trends or issues were identified at any dose level.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,INDUSTRY,,,,,,,2024,0.0
NCT04611126,,2020-10-20,,,2024-07-17,2020-10-26,2020-11-02,ACTUAL,,,,,,,2024-07-17,2024-07-19,ACTUAL,2021-04-22,ACTUAL,2021-04-22,2024-07,2024-07-31,2024-07-02,ACTUAL,2024-07-02,2024-03-03,ACTUAL,2024-03-03,,INTERVENTIONAL,,,"T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Metastatic Ovarian Cancer","T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Advanced Ovarian-, Fallopian Tube- and Primary Peritoneal Cancer",TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,Herlev Hospital,,2.0,,Slow recruitment,f,,,,t,f,f,,,,,,,,,,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,OTHER,,,,,,,2024,0.0
NCT02809690,,2016-06-19,,,2023-09-03,2016-06-21,2016-06-22,ESTIMATED,,,,,,,2023-09-03,2023-09-07,ACTUAL,2016-09-12,ACTUAL,2016-09-12,2023-09,2023-09-30,2021-07-21,ACTUAL,2021-07-21,2021-07-21,ACTUAL,2021-07-21,,INTERVENTIONAL,,,18F-FMAU PET/CT in Diagnosing and Characterizing Prostate Cancer,Pilot Feasibility Study of 18F-FMAU PET for Diagnosing and Characterizing Prostate Cancer,TERMINATED,,PHASE1,18.0,ACTUAL,University of Southern California,,1.0,,Slow accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,OTHER,,,,,,,2021,0.0
NCT03382899,,2017-12-18,2020-12-04,,2021-01-15,2017-12-21,2017-12-26,ACTUAL,2021-01-15,2021-01-20,ACTUAL,,,,2021-01-15,2021-01-20,ACTUAL,2018-03-19,ACTUAL,2018-03-19,2020-07,2020-07-31,2020-03-05,ACTUAL,2020-03-05,2019-12-06,ACTUAL,2019-12-06,,INTERVENTIONAL,Cypress 1,All randomized participants.,Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer,A Randomized Phase 2 Trial of AM0010 in Combination With Pembrolizumab vs. Pembrolizumab Alone as First-Line (1L) Therapy in Patients With Stage IV / Metastatic Wild Type (WT) Non-Small Cell Lung Cancer and Tumors With High Expression of PD-L1 (> 50%),TERMINATED,,PHASE2,101.0,ACTUAL,Eli Lilly and Company,"Study was terminated early after completion of primary analysis; hence, no mature data were available for final analysis.",2.0,,The CYPRESS-1 trial was closed early after the planned primary analysis because the risk benefit ratio is unfavorable.,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://www.clinicalstudydatarequest.com,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,INDUSTRY,,,,,,,2020,0.0
NCT03837756,,2019-02-07,,,2023-05-22,2019-02-08,2019-02-12,ACTUAL,,,,,,,2023-05-22,2023-05-23,ACTUAL,2019-05-06,ACTUAL,2019-05-06,2023-05,2023-05-31,2023-05-01,ACTUAL,2023-05-01,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,TITAN,,Combining TLR9 Agonist With bNAbs for Reservoir Reduction and Immunological Control of HIV,"Combining a TLR9 Agonist With Broadly Neutralizing Antibodies for Reservoir Reduction and Immunological Control of HIV Infection: An Investigator-initiated Randomized, Placebo-controlled, Phase IIa Trial.",COMPLETED,,PHASE2,47.0,ACTUAL,University of Aarhus,,4.0,,,f,,,,t,t,f,,,t,,,Data will become available following publication of the specific dataset with no planned end date.,Access to the data sharing will be given to researchers who provide a methodologically sound proposal for any type of analysis and requires IRB/Ethics committee approval (if applicable). Proposal should be addressed to olesoega@rm.dk,,YES,"Individual deidentified participant data (including data dictionaries) will be shared following the publication of the primary and secondary endpoints as outlined in this protocol. Data to be shared includes deidentified data points in published, peer-reviewed articles. Additional, related documents will also be available (study protocol, informed consent form, statistical analysis plan).",2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,OTHER,,,,,,,2023,0.0
NCT04131556,,2019-10-17,2020-12-22,,2020-12-22,2019-10-17,2019-10-18,ACTUAL,2020-12-22,2021-01-19,ACTUAL,,,,2020-12-22,2021-01-19,ACTUAL,2019-10-25,ACTUAL,2019-10-25,2020-12,2020-12-31,2020-01-06,ACTUAL,2020-01-06,2020-01-06,ACTUAL,2020-01-06,,INTERVENTIONAL,,Safety set 1 consisted of all participants who received at least 1 dose of maribavir in Part 1.,A Study Comparing the Pharmacokinetics and Palatability of Two Candidate Pediatric Powder-for-Oral-Suspension Formulations of Maribavir to the Current Maribavir Tablet Formulation Administered in Healthy Adult Participants,"A Phase 1, Open-label, Randomized, Crossover, Bioavailability, Dose Proportionality, and Food Effect Study Comparing the Pharmacokinetics and Palatability of Two Candidate Pediatric Powder-for-Oral-Suspension Formulations of Maribavir to the Current Maribavir Tablet Formulation Administered in Healthy Adult Subjects",TERMINATED,,PHASE1,20.0,ACTUAL,Takeda,"Sponsor terminated this study based on the planned interim analysis of the data of Part 1, palatability of both pediatric formulations was not acceptable.",10.0,,"The study was stopped because based on the planned interim analysis of the data of Part 1, palatability of both pediatric formulations was not acceptable.",f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 19:59:10.711542,2024-10-15 19:59:10.711542,INDUSTRY,,,,,,,2020,0.0
NCT02710669,,2016-03-12,2021-04-20,,2022-06-01,2016-03-16,2016-03-17,ESTIMATED,2021-04-20,2021-05-14,ACTUAL,,,,2022-06-01,2022-06-03,ACTUAL,2016-10,,2016-10-31,2022-06,2022-06-30,2020-04,ACTUAL,2020-04-30,2020-03-11,ACTUAL,2020-03-11,,INTERVENTIONAL,,One participant was not randomized,New Formulations of Propafenone to Treat Atrial Fibrillation,Comparison of (R) and (S) Propafenone for Prevention of Atrial Fibrillation Induction,TERMINATED,,PHASE1/PHASE2,193.0,ACTUAL,Vanderbilt University Medical Center,,3.0,,Study halted/terminated prematurely due to COVID.,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-15 19:59:10.711542,2024-10-15 19:59:10.711542,OTHER,,,,,,,2020,0.0
NCT04093115,,2019-09-10,,,2020-09-01,2019-09-14,2019-09-17,ACTUAL,,,,,,,2020-09-01,2020-09-03,ACTUAL,2019-12-09,ACTUAL,2019-12-09,2020-09,2020-09-30,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,HNSCC,,Study of CX1106 in Patients With Advanced Head and Neck Squamous Cell Carcinoma,A Clinical Trial to Evaluate the Efficacy and Safety of CX1106 in Patients With Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma After Failure of or Unfit for Platinum-containing Therapy,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Beijing Konruns Pharmaceutical Co., Ltd.",,1.0,,The study was terminated voluntarily by the sponsor due to changes in clinical development strategy.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 19:59:10.711542,2024-10-15 19:59:10.711542,INDUSTRY,,,,,,,2020,0.0
NCT03895372,,2019-03-13,2021-05-03,,2021-08-25,2019-03-27,2019-03-29,ACTUAL,2021-08-25,2021-08-27,ACTUAL,,,,2021-08-25,2021-08-27,ACTUAL,2019-06-27,ACTUAL,2019-06-27,2021-08,2021-08-31,2020-11-26,ACTUAL,2020-11-26,2020-05-21,ACTUAL,2020-05-21,,INTERVENTIONAL,,Demographic and baseline characteristics were summarized by randomized treatment group for all randomized and treated participants.,A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis,"A PHASE 2, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS",COMPLETED,,PHASE2,179.0,ACTUAL,Pfizer,,5.0,,,f,,,,t,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-14 21:22:01.437344,2024-10-14 21:22:01.437344,INDUSTRY,,,,,,,2020,1.0
NCT05404919,,2022-05-07,,,2024-08-02,2022-05-31,2022-06-03,ACTUAL,,,,,,,2024-08-02,2024-08-06,ACTUAL,2022-09-06,ACTUAL,2022-09-06,2024-08,2024-08-31,2024-08-01,ESTIMATED,2024-08-01,2024-08-01,ACTUAL,2024-08-01,,INTERVENTIONAL,INHIBITOR,,Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates,Utilization of Hepatitis B Virus Nucleic Acid Test Positive Donors for Hepatitis B Vaccinated Lung Transplant Candidates,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Pennsylvania,,1.0,,Insufficient enrollment; departure of primary investigator from institution,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,OTHER,,,,,,,2024,0.0
NCT04420624,,2020-04-29,,,2022-12-14,2020-06-05,2020-06-09,ACTUAL,,,,,,,2022-12-14,2022-12-15,ACTUAL,2020-12-04,ACTUAL,2020-12-04,2022-12,2022-12-31,2022-05-24,ACTUAL,2022-05-24,2022-05-24,ACTUAL,2022-05-24,,INTERVENTIONAL,COLD-MI,,COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction,COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction,TERMINATED,,PHASE2/PHASE3,54.0,ACTUAL,"University Hospital, Montpellier",,2.0,,Inclusion period completed,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,OTHER,,,,,,,2022,0.0
NCT04167618,,2019-11-11,2023-09-11,,2023-09-11,2019-11-14,2019-11-19,ACTUAL,2023-09-11,2023-10-06,ACTUAL,,,,2023-09-11,2023-10-06,ACTUAL,2021-09-30,ACTUAL,2021-09-30,2023-09,2023-09-30,2022-08-11,ACTUAL,2022-08-11,2022-08-11,ACTUAL,2022-08-11,,INTERVENTIONAL,,,177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma,A Phase I/II Dose-escalation and Expansion Cohort Trial of Intracerebroventricular Radioimmunotherapy Using 177Lu-DTPA-Omburtamab in Pediatric and Adolescent Patients With Recurrent or Refractory Medulloblastoma,TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,Y-mAbs Therapeutics,The trial was terminated after 2 subjects due to a business strategy decision. At this point the maximum tolerated dose was not established.,1.0,,Business priorities,f,,,,t,t,f,,,,,,,,,,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,INDUSTRY,,,,,,,2022,0.0
NCT03637842,,2018-07-19,2020-12-09,,2021-01-12,2018-08-16,2018-08-20,ACTUAL,2021-01-12,2021-01-28,ACTUAL,,,,2021-01-12,2021-01-28,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2021-01,2021-01-31,2020-02-29,ACTUAL,2020-02-29,2020-02-29,ACTUAL,2020-02-29,,INTERVENTIONAL,,,Lorcaserin for Cannabis Use Disorder,Randomized Controlled Trial of Lorcaserin for Cannabis Use Disorder,TERMINATED,,EARLY_PHASE1,5.0,ACTUAL,New York State Psychiatric Institute,Study was prematurely terminated due to FDA recall of Lorcaserin.,2.0,,terminated due to lorcaserin recall,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,OTHER,,,,,,,2020,0.0
NCT02588170,,2015-10-26,,,2023-03-29,2015-10-26,2015-10-27,ESTIMATED,,,,,,,2023-03-29,2023-03-30,ACTUAL,2015-12-07,ACTUAL,2015-12-07,2023-03,2023-03-31,2022-07-07,ACTUAL,2022-07-07,2019-03-31,ACTUAL,2019-03-31,,INTERVENTIONAL,,,Phase III Study of Surufatinib in Treating Advanced Extrapancreatic Neuroendocrine Tumors,"A Randomized, Double-blind, Multi-center Phase III Clinical Study to Assess the Efficacy and Safety of Surufatinib Compared to Placebo in Patients With Advanced Extrapancreatic Neuroendocrine Tumors",COMPLETED,,PHASE3,219.0,ACTUAL,Hutchmed,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,INDUSTRY,,,,,,,2022,1.0
NCT04077970,,2019-09-01,,,2023-03-11,2019-09-01,2019-09-04,ACTUAL,,,,,,,2023-03-11,2023-03-14,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2023-03,2023-03-31,2023-01-01,ACTUAL,2023-01-01,2022-12-01,ACTUAL,2022-12-01,,INTERVENTIONAL,,,Intrauterine Flushing With Follicular Fluid Plus Granulosa Cells,Evaluation of Implantation and Clinical Pregnancy After Intrauterine Flushing of Infertile Patients With Follicular Fluid Plus Granulosa Cells- Randomized Controlled Trial,COMPLETED,,PHASE3,140.0,ACTUAL,Royan Institute,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,OTHER_GOV,,,,,,,2023,0.0
NCT04009096,,2019-07-03,2022-09-12,,2023-10-10,2019-07-03,2019-07-05,ACTUAL,2023-10-10,2024-04-12,ACTUAL,,,,2023-10-10,2024-04-12,ACTUAL,2019-07-18,ACTUAL,2019-07-18,2022-09,2022-09-30,2022-07-07,ACTUAL,2022-07-07,2022-07-07,ACTUAL,2022-07-07,,INTERVENTIONAL,,,VAC071: A Study to Assess Efficacy of the ChAd63/MVA PvDBP Vaccines,A Phase IIa Challenge Study to Assess Efficacy of the Plasmodium Vivax Malaria Vaccine Candidates ChAd63 PvDBP and MVA PvDBP in Healthy Adults Living in the UK,COMPLETED,,PHASE2,16.0,ACTUAL,University of Oxford,,3.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,OTHER,,,,,,,2022,1.0
NCT03766750,,2018-12-05,,,2022-07-25,2018-12-05,2018-12-06,ACTUAL,,,,,,,2022-07-25,2022-07-27,ACTUAL,2021-12,ESTIMATED,2021-12-31,2022-07,2022-07-31,2023-11,ESTIMATED,2023-11-30,2023-10,ESTIMATED,2023-10-31,,INTERVENTIONAL,,,Efficacy and Safety of Lima Association in the Control of Type II Diabetes Mellitus.,"Randomized, Double-blind, Multicenter, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Lima Association in the Control of Type II Diabetes Mellitus",WITHDRAWN,,PHASE3,0.0,ACTUAL,EMS,,3.0,,Sponsor decision,f,,,,t,f,f,,,,,,,,,,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,INDUSTRY,,,,,,,2023,0.0
NCT04680286,,2020-12-11,,,2024-02-26,2020-12-17,2020-12-22,ACTUAL,,,,,,,2024-02-26,2024-02-28,ACTUAL,2020-11-16,ACTUAL,2020-11-16,2023-04,2023-04-30,2024-02-01,ACTUAL,2024-02-01,2024-01-30,ACTUAL,2024-01-30,,INTERVENTIONAL,METACEBO,,Intraoperative Methadone in Children Undergoing Surgery,"The Use of Intraoperative Methadone in Children Undergoing Open Urological Surgery: a Randomized, Double-blind Trial",TERMINATED,,PHASE3,60.0,ACTUAL,University of Aarhus,,2.0,,Slow recruitment due to covid-19 and organizational changes.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,OTHER,,,,,,,2024,0.0
NCT05046795,,2021-09-07,,,2023-08-16,2021-09-07,2021-09-16,ACTUAL,,,,,,,2023-08-16,2023-08-18,ACTUAL,2021-11-10,ACTUAL,2021-11-10,2023-08,2023-08-31,2023-07-26,ACTUAL,2023-07-26,2023-07-26,ACTUAL,2023-07-26,,INTERVENTIONAL,,,Revefenacin in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease(COPD),"A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study of Nebulized Revefenacin Inhalation Solution in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD).",COMPLETED,,PHASE3,258.0,ACTUAL,Viatris Inc.,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,INDUSTRY,,,,,,,2023,1.0
NCT02039674,,2014-01-16,2017-10-27,,2022-10-13,2014-01-16,2014-01-17,ESTIMATED,2017-10-27,2017-12-02,ACTUAL,,,,2022-10-13,2022-11-08,ACTUAL,2014-02-21,,2014-02-21,2022-10,2022-10-31,2021-10-18,ACTUAL,2021-10-18,2016-11-07,ACTUAL,2016-11-07,,INTERVENTIONAL,,"For Cohorts A, B, C and G, the analysis population consisted of all randomized participants. For Cohorts D, E, F and H, the analysis population consisted of all treated participants.",A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021),A Phase I/II Study of MK-3475 (SCH900475) in Combination With Chemotherapy or Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma,COMPLETED,,PHASE1/PHASE2,267.0,ACTUAL,Merck Sharp & Dohme LLC,,14.0,,,f,,,,f,,,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd,2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,INDUSTRY,,,,,,,2021,1.0
NCT06245291,,2024-01-11,,,2024-08-08,2024-02-06,2024-02-07,ACTUAL,,,,,,,2024-08-08,2024-08-12,ACTUAL,2024-05-01,ACTUAL,2024-05-01,2024-06,2024-06-30,2024-08-01,ACTUAL,2024-08-01,2024-08-01,ACTUAL,2024-08-01,,INTERVENTIONAL,,,Study of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab in Subjects With Chronic HBV Infection,"A Phase 2a, Open-Label Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab, a PD-L1 Monoclonal Antibody, in Subjects With Chronic HBV Infection",WITHDRAWN,,PHASE2,0.0,ACTUAL,Arbutus Biopharma Corporation,,3.0,,Sponsor Decision,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,INDUSTRY,,,,,,,2024,0.0
NCT02485366,,2015-06-26,,,2020-04-23,2015-06-26,2015-06-30,ESTIMATED,,,,,,,2020-04-23,2020-04-27,ACTUAL,2020-06,ESTIMATED,2020-06-30,2020-04,2020-04-30,2021-06,ESTIMATED,2021-06-30,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,"Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery","Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery",WITHDRAWN,,PHASE4,0.0,ACTUAL,Duke University,,1.0,,Product unavailability,f,,,,,t,f,,,,,,,,,,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,OTHER,,,,,,,2021,0.0
NCT02519543,,2015-08-03,,,2021-01-12,2015-08-06,2015-08-11,ESTIMATED,,,,,,,2021-01-12,2021-01-13,ACTUAL,2015-09,,2015-09-30,2021-01,2021-01-31,2020-09,ACTUAL,2020-09-30,2020-09,ACTUAL,2020-09-30,,INTERVENTIONAL,TRIO-BD,,Treating Insulin Resistance as a Strategy to Improve Outcome in Refractory Bipolar Disorder,"Treating Insulin Resistance to Improve Outcome in Refractory Bipolar Disorder: a Randomized, Double-blind, Placebo-control Study of the Efficacy of Metformin in Patients With Insulin Resistance and Non-remitting Bipolar Illness",COMPLETED,,PHASE3,50.0,ACTUAL,Nova Scotia Health Authority,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,OTHER,,,,,,,2020,1.0
NCT02403193,,2015-03-17,,,2022-01-03,2015-03-25,2015-03-31,ESTIMATED,,,,,,,2022-01-03,2022-01-12,ACTUAL,2015-10,,2015-10-31,2022-01,2022-01-31,2021-11-24,ACTUAL,2021-11-24,2021-10,ACTUAL,2021-10-31,,INTERVENTIONAL,AdenONCO,,Trial of PBF-509 and PDR001 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC),Phase I/Ib Trial of Single Agent PBF-509 and in Combination With PDR001 for Patients With Advanced NSCLC,COMPLETED,,PHASE1,92.0,ACTUAL,Palobiofarma SL,,9.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,INDUSTRY,,,,,,,2021,1.0
NCT04542694,,2020-09-04,2020-10-11,,2020-11-03,2020-09-04,2020-09-09,ACTUAL,2020-11-03,2020-11-05,ACTUAL,,,,2020-11-03,2020-11-05,ACTUAL,2020-05-21,ACTUAL,2020-05-21,2020-11,2020-11-30,2020-08-20,ACTUAL,2020-08-20,2020-08-10,ACTUAL,2020-08-10,,INTERVENTIONAL,,,Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19,"Open-label Randomized Multicenter Comparative Study on the Efficacy and Safety of Areplivir Film-coated Tablets (PROMOMED RUS LLC, Russia) in Patients Hospitalized With COVID-19",COMPLETED,,PHASE3,200.0,ACTUAL,"Promomed, LLC",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,OTHER,,,,,,,2020,1.0
NCT04866017,,2020-10-28,,,2024-01-17,2021-04-26,2021-04-29,ACTUAL,,,,,,,2024-01-17,2024-01-18,ACTUAL,2021-06-17,ACTUAL,2021-06-17,2024-01,2024-01-31,2023-10-17,ACTUAL,2023-10-17,2023-10-17,ACTUAL,2023-10-17,,INTERVENTIONAL,,,A Study to Compare Ociperlimab Plus Tislelizumab Versus Durvalumab Following Concurrent Chemoradiotherapy (cCRT) in Patients With Stage III Unresectable Non-Small Cell Lung Cancer,"A Phase 3, Randomized, Open-Label Study to Compare Ociperlimab (BGB-A1217) Plus Tislelizumab (BGB-A317) Versus Durvalumab in Patients With Locally Advanced, Unresectable, PD-L1-Selected Non-Small Cell Lung Cancer Whose Disease Has Not Progressed After Concurrent Chemoradiotherapy",TERMINATED,,PHASE3,63.0,ACTUAL,BeiGene,,3.0,,This decision was conducted by the sponsor and not driven by safety concerns as no new safety signals have been observed in the ociperlimab program.,f,,,,t,t,f,,,t,,,,,,YES,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,INDUSTRY,,,,,,,2023,0.0
NCT03193931,,2017-05-31,,,2023-02-03,2017-06-19,2017-06-21,ACTUAL,,,,,,,2023-02-03,2023-02-06,ACTUAL,2018-02-02,ACTUAL,2018-02-02,2023-02,2023-02-28,2022-03-23,ACTUAL,2022-03-23,2021-11-24,ACTUAL,2021-11-24,,INTERVENTIONAL,ELDORANDO,,"Study Comparing Pembrolizumab With Methotrexate in Elderly, Frail or Cisplatin-ineligible Patients With Head and Neck Cancers","A Randomized Phase II Study Comparing Pembrolizumab With Methotrexate in Elderly, Frail or Cisplatin-ineligible Patients With Head and Neck Cancers",TERMINATED,,PHASE2,47.0,ACTUAL,AIO-Studien-gGmbH,,2.0,,A very low recruitment rate made it impossible to reach the recruitment goal wthin an acceptable timeframe.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 10:35:52.141618,2024-10-15 10:35:52.141618,OTHER,,,,,,,2022,0.0
NCT01991873,,2013-10-22,,,2023-06-13,2013-11-18,2013-11-25,ESTIMATED,,,,,,,2023-06-13,2023-06-15,ACTUAL,2014-04,,2014-04-30,2023-06,2023-06-30,2023-02-18,ACTUAL,2023-02-18,2023-02-18,ACTUAL,2023-02-18,,INTERVENTIONAL,PanaMa,,Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer,Randomized Phase II Study for Evaluation of Efficacy and Safety of Maintenance Treatment With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction Treatment With mFOLFOX6 Plus Panitumumab and Re-induction With mFOLFOX6 Plus Panitumumab in Case of Progression for First-line Treatment of Patients With Metastatic Colorectal Cancer,COMPLETED,,PHASE2,387.0,ACTUAL,AIO-Studien-gGmbH,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-14 21:22:01.437344,2024-10-14 21:22:01.437344,OTHER,,,,,,,2023,1.0
NCT04544709,,2020-08-28,2023-08-17,,2023-12-07,2020-09-03,2020-09-10,ACTUAL,2023-12-07,2023-12-11,ACTUAL,,,,2023-12-07,2023-12-11,ACTUAL,2019-02-14,ACTUAL,2019-02-14,2023-12,2023-12-31,2022-07-29,ACTUAL,2022-07-29,2022-07-29,ACTUAL,2022-07-29,,INTERVENTIONAL,,Baseline information was collected from 3 participants before the study was discontinued early.,Intradiscal Platelet Rich Plasma,Intradiscal Platelet-Rich Plasma Injection for Chronic Discogenic Low Back Pain,TERMINATED,,PHASE4,3.0,ACTUAL,University of Utah,The single greatest limitation is that the study was ended early due to extremely low participant enrollment.,1.0,,Low enrollment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,OTHER,,,,,,,2022,0.0
NCT01332968,,2011-04-08,2017-02-03,,2022-08-09,2011-04-08,2011-04-11,ESTIMATED,2017-05-05,2017-06-07,ACTUAL,,,,2022-08-09,2022-08-11,ACTUAL,2011-07-06,ACTUAL,2011-07-06,2022-08,2022-08-31,2021-07-30,ACTUAL,2021-07-30,2016-02-01,ACTUAL,2016-02-01,,INTERVENTIONAL,,The intent-to treat (ITT) population was defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.,A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM),"A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders",COMPLETED,,PHASE3,1401.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,INDUSTRY,,,,,,,2021,1.0
NCT04062838,,2018-08-01,,,2022-08-20,2019-08-19,2019-08-20,ACTUAL,,,,,,,2022-08-20,2022-08-23,ACTUAL,2020-08-01,ESTIMATED,2020-08-01,2020-05,2020-05-31,2022-12-01,ESTIMATED,2022-12-01,2021-12-01,ESTIMATED,2021-12-01,,INTERVENTIONAL,,,Prolotherapy for the Treatment of Partial Rotator Cuff Tears,Prospective Pilot Study: Prolotherapy For The Treatment Of Patients With Partial Rotator Cuff Tears,WITHDRAWN,,PHASE4,0.0,ACTUAL,Hadassah Medical Organization,,1.0,,I did not receive funding to finance this study,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,OTHER,,,,,,,2022,0.0
NCT02608268,,2015-10-15,2023-08-28,,2023-12-05,2015-11-17,2015-11-18,ESTIMATED,2023-12-05,2023-12-06,ACTUAL,,,,2023-12-05,2023-12-06,ACTUAL,2015-11-23,ACTUAL,2015-11-23,2023-12,2023-12-31,2022-08-30,ACTUAL,2022-08-30,2022-08-30,ACTUAL,2022-08-30,,INTERVENTIONAL,,,Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies,Phase I-Ib/II Open-label Multi-center Study of the Safety and Efficacy of MBG453 as Single Agent and in Combination With PDR001 in Adult Patients With Advanced Malignancies,TERMINATED,,PHASE1/PHASE2,252.0,ACTUAL,Novartis,,10.0,,Business reasons,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,INDUSTRY,,,,,,,2022,0.0
NCT04670653,,2020-12-11,,,2022-08-03,2020-12-11,2020-12-17,ACTUAL,,,,,,,2022-08-03,2022-08-05,ACTUAL,2022-08-01,ACTUAL,2022-08-01,2022-08,2022-08-31,2023-10,ESTIMATED,2023-10-31,2023-07,ESTIMATED,2023-07-31,,INTERVENTIONAL,,,Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis,"National, Multicenter, Randomized, Simple-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis in Participants With Age Greater Than or Equal to 12 Years.",WITHDRAWN,,PHASE3,0.0,ACTUAL,EMS,,2.0,,Sponsor decision,f,,,,t,f,f,,,,,,,,,,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,INDUSTRY,,,,,,,2023,0.0
NCT03483688,,2018-03-14,,,2020-03-03,2018-03-23,2018-03-30,ACTUAL,,,,,,,2020-03-03,2020-03-05,ACTUAL,2018-03-06,ACTUAL,2018-03-06,2018-03,2018-03-31,2020-01-10,ACTUAL,2020-01-10,2019-12-10,ACTUAL,2019-12-10,,INTERVENTIONAL,,,A PhaseⅠb Study Evaluating Safety and Efficacy of C-CAR011 Treatment in B- NHL Subjects,A Phase Ⅰb Study Evaluating Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor T-cell (C-CAR011) Treatment in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma,COMPLETED,,PHASE1,6.0,ACTUAL,Peking Union Medical College Hospital,,1.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,OTHER,,,,,,,2020,1.0
NCT01665274,,2012-08-05,,,2022-09-29,2012-08-14,2012-08-15,ESTIMATED,,,,,,,2022-09-29,2022-10-03,ACTUAL,2013-09,,2013-09-30,2022-09,2022-09-30,2022-09,ACTUAL,2022-09-30,2020-08,ACTUAL,2020-08-31,,INTERVENTIONAL,repeat,,Efficiency of XELOX Neoadjuvant Chemotherapy in Gastric Cancer,A Randomized Single Center Controlled Study of Perioperative Chemotherapy of Oxaliplatin Combined With Capecitabine (XELOX) Versus XELOX as Post-operative Chemotherapy in Advanced Gastric Adenocarcinoma With D2 Dissection,TERMINATED,,PHASE2,15.0,ACTUAL,Harbin Medical University,,2.0,,"we are working on a larger similar multicenter cinical trials as a participant.so in order to avoid conflicts of interest, we have to suspended this project.",f,,,,t,,,,,,,,,,,,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,OTHER,,,,,,,2022,0.0
NCT01218555,,2010-10-08,2021-05-27,,2021-11-19,2010-10-08,2010-10-11,ESTIMATED,2021-11-19,2022-01-27,ACTUAL,,,,2021-11-19,2022-01-27,ACTUAL,2010-09-09,ACTUAL,2010-09-09,2021-11,2021-11-30,2020-11-05,ACTUAL,2020-11-05,2020-11-05,ACTUAL,2020-11-05,,INTERVENTIONAL,,,Study of Everolimus (RAD001) in Combination With Lenalidomide,Phase I Study of Everolimus (RAD001) in Combination With Lenalidomide in Patients With Advanced Solid Malignancies Enriched for Renal Cell Carcinoma,COMPLETED,,PHASE1,44.0,ACTUAL,Emory University,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,OTHER,,,,,,,2020,1.0
NCT04775797,,2021-02-24,,,2022-11-17,2021-02-26,2021-03-01,ACTUAL,,,,,,,2022-11-17,2022-11-21,ACTUAL,2021-06-25,ACTUAL,2021-06-25,2022-11,2022-11-30,2022-11-17,ACTUAL,2022-11-17,2022-11-17,ACTUAL,2022-11-17,,INTERVENTIONAL,,,"Safety, Tolerability, and Pharmacokinetics of AB-836 in Healthy Subjects and Subjects With Chronic HBV Infection","A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AB-836, an HBV Capsid Inhibitor, in Healthy Subjects and Subjects With Chronic HBV Infection",TERMINATED,,PHASE1,110.0,ACTUAL,Arbutus Biopharma Corporation,,5.0,,Safety,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,INDUSTRY,,,,,,,2022,0.0
NCT03722108,,2018-10-25,,,2023-10-13,2018-10-25,2018-10-26,ACTUAL,,,,,,,2023-10-13,2023-10-16,ACTUAL,2019-02-07,ACTUAL,2019-02-07,2023-10,2023-10-31,2022-05-19,ACTUAL,2022-05-19,2022-05-19,ACTUAL,2022-05-19,,INTERVENTIONAL,REGIRI,,Regorafenib Combined With Irinotecan as Second-line in Patients With Metastatic Gastro-oesophageal Adenocarcinomas,A Randomised Phase 2 Trial Assessing REGorafenib Combined With IRInotecan as Second-line Treatment in Patients With Metastatic Gastro-oesophageal Adenocarcinomas,TERMINATED,,PHASE1/PHASE2,89.0,ACTUAL,UNICANCER,,2.0,,Unfavorable benefit-risk balance in the experimental arm following the IDMC for intermediate efficacy and safety analysis,f,,,,t,f,f,,,,,,,,,NO,"Individual Participant Data will not be shared at an individual level, they will be part of the study database including all enrolled patients",2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,OTHER,,,,,,,2022,0.0
NCT04479371,,2020-07-16,,,2021-08-09,2020-07-16,2020-07-21,ACTUAL,,,,,,,2021-08-09,2021-08-16,ACTUAL,2021-07,ESTIMATED,2021-07-31,2021-08,2021-08-31,2023-07-30,ESTIMATED,2023-07-30,2022-07-30,ESTIMATED,2022-07-30,,INTERVENTIONAL,,,Liposomal Bupivacaine vs Standard Penile Block for Hypospadias Repair,Prospective Randomized Trial of Penile Nerve Block With Liposomal Bupivacaine for Hypospadias Repair vs Standard Penile Block With Bupivacaine,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,Limited funding and resources to complete FDA requirements for enrollment,f,,,,f,f,f,,,,,,Until trial completion and data publication in 2023,Research team only,,YES,"An adequate plan is in place to protect the patient identifiers. The plan includes that the electronic datasheet will reside in the researchers UTSW secure O:drive and will not be transmitted outside the institution as this is a PI-initiated trial. The UTSW HRPP/IRB offices, Children's and UTSW offices of research administration, and any state or federal monitors may be given access to study records or data on site, as necessary. The data will be password protected, passwords will be changed on a regular basis, access to the data will be restricted to the research team only, and all paper records will be kept in locked file cabinets and access limited to authorized personnel only. The identifiers will be destroyed after the de-identified results have been submitted for publication.",2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,OTHER,,,,,,,2023,0.0
NCT04217148,,2019-12-30,,,2021-09-22,2020-01-02,2020-01-03,ACTUAL,,,,,,,2021-09-22,2021-09-28,ACTUAL,2020-01-01,ACTUAL,2020-01-01,2021-09,2021-09-30,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,The Combination of ATRA and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia,"The Combination of Oral All-trans Retinoic Acid and High-dose Dexamethasone vs High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia: A Multicenter, Randomized, Open-label Trial",COMPLETED,,PHASE2,132.0,ACTUAL,Peking University People's Hospital,,2.0,,,f,,,,,f,f,,,,,,These data will be available beginning 3 months and ending 36 months following publication.,All requests must include a description of the research proposal and be sent to the corresponding author (zhangxh@bjmu.edu.cn). Data requestors will need to sign a data access agreement to obtain access.,,YES,"Qualified researchers can request access to data, including deidentified individual participant data, and the study protocol from this clinical trial. These data will be available beginning 3 months and ending 36 months following publication. All requests must include a description of the research proposal and be sent to the corresponding author (zhangxh@bjmu.edu.cn). Data requestors will need to sign a data access agreement to obtain access.",2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,OTHER,,,,,,,2020,1.0
NCT03176277,,2017-05-19,2023-11-21,,2024-07-03,2017-06-01,2017-06-05,ACTUAL,2024-04-18,2024-05-16,ACTUAL,,,,2024-07-03,2024-07-15,ACTUAL,2017-06-26,ACTUAL,2017-06-26,2024-07,2024-07-31,2023-01-20,ACTUAL,2023-01-20,2022-12-01,ACTUAL,2022-12-01,,INTERVENTIONAL,,"Full analysis set, respective of Part A and Part D study.",A Study of ONO-7475 in Patients With Acute Leukemias,"A Phase I/II Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Efficacy of ONO-7475 in Patients With Acute Leukemias or Myelodysplastic Syndromes",TERMINATED,,PHASE1/PHASE2,42.0,ACTUAL,Ono Pharmaceutical Co. Ltd,,4.0,,Protocol defined futility criteria,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,INDUSTRY,,,,,,,2023,0.0
NCT02647762,,2015-12-16,,,2020-12-17,2016-01-04,2016-01-06,ESTIMATED,,,,,,,2020-12-17,2020-12-19,ACTUAL,2017-10-30,ACTUAL,2017-10-30,2020-03,2020-03-31,2020-11-30,ACTUAL,2020-11-30,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,,,CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid Arthritis,"A Phase 3, Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis",TERMINATED,,PHASE3,244.0,ACTUAL,Can-Fite BioPharma,,4.0,,Interim analysis results,f,,,,f,f,f,,,,,,,,,,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,INDUSTRY,,,,,,,2020,0.0
NCT04885491,,2021-02-15,,,2023-07-31,2021-05-12,2021-05-13,ACTUAL,,,,,,,2023-07-31,2023-08-01,ACTUAL,2021-05-07,ACTUAL,2021-05-07,2023-07,2023-07-31,2023-04-30,ACTUAL,2023-04-30,2023-04-30,ACTUAL,2023-04-30,,INTERVENTIONAL,,,"A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in COVID-19 Patients With Acute Pulmonary Hypertension","An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of PDNO (Nitrosooxypropanol) Infusion in COVID-19 Patients With Acute Pulmonary Hypertension",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Attgeno AB,,1.0,,"Since the availability of vaccines, a drastic drop in number of patients with increased PAP was observed and when the WHO re-categorized the COVID-19 pandemic from PHEIC to an established and ongoing health issue the study was withdrawn.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,INDUSTRY,,,,,,,2023,0.0
NCT03744676,,2018-11-07,2023-11-09,,2023-12-05,2018-11-15,2018-11-16,ACTUAL,2023-12-05,2023-12-06,ACTUAL,,,,2023-12-05,2023-12-06,ACTUAL,2018-11-29,ACTUAL,2018-11-29,2023-12,2023-12-31,2023-09-22,ACTUAL,2023-09-22,2023-09-22,ACTUAL,2023-09-22,,INTERVENTIONAL,,,A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007),A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting,COMPLETED,,PHASE2,104.0,ACTUAL,"Juno Therapeutics, a Subsidiary of Celgene",,1.0,,,f,,,,f,t,f,,,,,,See Plan Description,See Plan Description,https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,INDUSTRY,,,,,,,2023,1.0
NCT03901612,,2019-04-02,,,2023-08-15,2019-04-02,2019-04-03,ACTUAL,,,,,,,2023-08-15,2023-08-21,ACTUAL,2019-01-05,ACTUAL,2019-01-05,2023-08,2023-08-31,2023-08-14,ACTUAL,2023-08-14,2023-08-14,ACTUAL,2023-08-14,,INTERVENTIONAL,ESPADULT2,,Erector Spinae Catheter for Open Heart Surgery,Evaluation of a Peri-Operative Continuous Bilateral Erector Spinae Plane (ESP) Continuous Catheter After Open Cardiac Surgery in Adults,WITHDRAWN,,PHASE4,0.0,ACTUAL,Vinmec Healthcare System,,2.0,,covid and surgeon left,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,OTHER,,,,,,,2023,0.0
NCT05024058,,2021-08-23,2023-02-09,,2024-06-14,2021-08-23,2021-08-27,ACTUAL,2023-09-11,2023-09-15,ACTUAL,,,,2024-06-14,2024-06-18,ACTUAL,2021-11-16,ACTUAL,2021-11-16,2024-06,2024-06-30,2022-08-09,ACTUAL,2022-08-09,2022-08-09,ACTUAL,2022-08-09,,INTERVENTIONAL,PEARL-PROVOKE,"The Randomized Analysis Set (RAN) consisted of all randomized participants, regardless of whether or not they received a dose of study drug. Participants were analyzed according to the treatment they were assigned. Data could not be analyzed because no subject completed Week 12 in the sympomatic dermographism cohort, 1 subject each completed the Week 12 in 72 mg ligelizumab and 120 mg ligelizumab groups in cold urticaria cohort, 1 subject completed Week 12 in cholinergic urticaria cohort.",Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines,"A Multi-center, Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Inducible Urticaria (CINDU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines",TERMINATED,,PHASE3,39.0,ACTUAL,Novartis,,8.0,,"Phase III PEARL studies (CQGE031C2302 and CQGE031C2303) with ligelizumab met their primary endpoint of superiority vs placebo at Week 12 for treatment of CSU, but not versus omalizumab. Decision to discontinue was not based on safety concerns.",f,,,,t,t,f,,,,,,,,,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,INDUSTRY,,,,,,,2022,0.0
NCT03054870,,2017-02-08,2021-06-17,,2021-08-30,2017-02-13,2017-02-16,ACTUAL,2021-08-30,2021-09-24,ACTUAL,,,,2021-08-30,2021-09-24,ACTUAL,2017-09-01,ACTUAL,2017-09-01,2021-08,2021-08-31,2020-11-23,ACTUAL,2020-11-23,2020-09-18,ACTUAL,2020-09-18,,INTERVENTIONAL,,Safety cohort - subjects who received any dose of Technegas,A Comparison of Technegas and Xenon-133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy,A Comparison of Technegas® and Xenon 133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy,TERMINATED,,PHASE3,226.0,ACTUAL,Cyclomedica Australia PTY Limited,"Unblinded analysis of imaging efficacy data was to be done at completion of study and all blinded readings. Due to the COVID-19 pandemic impact on enrollment, FDA recommended an unplanned interim analysis be performed using blind read data from 200 subjects. Interim analysis was done by independent 3rd party statistician and reviewed by a Data Efficacy Monitoring Committee (DEMC), which recommended termination of the study based on positive results. Sponsor agreed.",1.0,,Trial met primary efficacy endpoint target. No additional subjects necessary.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,INDUSTRY,,,,,,,2020,0.0
NCT05654870,,2022-12-08,,,2024-06-27,2022-12-08,2022-12-16,ACTUAL,,,,,,,2024-06-27,2024-07-01,ACTUAL,2023-01-05,ACTUAL,2023-01-05,2023-12,2023-12-31,2023-11-08,ACTUAL,2023-11-08,2023-11-08,ACTUAL,2023-11-08,,INTERVENTIONAL,,,"Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects With Schizophrenia",TERMINATED,,PHASE3,8.0,ACTUAL,Neurocrine Biosciences,,2.0,,Study ATS3020 was closed due to business reasons. Neurocrine Biosciences will continue to conduct study ATS3019 (NCT05110157). There were no unexpected safety findings for this compound that motivated the decision.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,INDUSTRY,,,,,,,2023,0.0
NCT04070313,,2019-08-20,,,2021-11-22,2019-08-25,2019-08-28,ACTUAL,,,,,,,2021-11-22,2021-12-06,ACTUAL,2019-07-11,ACTUAL,2019-07-11,2021-11,2021-11-30,2021-10-31,ACTUAL,2021-10-31,2021-10-31,ACTUAL,2021-10-31,,INTERVENTIONAL,,,A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in Taiwan,A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in Taiwan,TERMINATED,,PHASE2,36.0,ACTUAL,TTY Biopharm,,1.0,,"Study treatment is to use TS-1 (mono-chemotherapy agent) in adjuvant setting for pancreatic cancer, which may be less clinical benefit compared to combination therapy according to current trend at investigators' discretion.",f,,,,,f,f,,,,,,,,,,,2024-10-16 07:32:10.229271,2024-10-16 07:32:10.229271,INDUSTRY,,,,,,,2021,0.0
NCT00488605,,2007-06-14,,,2023-08-01,2007-06-18,2007-06-20,ESTIMATED,,,,,,,2023-08-01,2023-08-03,ACTUAL,2023-08-01,ACTUAL,2023-08-01,2023-08,2023-08-31,2023-08-01,ACTUAL,2023-08-01,2023-08-01,ACTUAL,2023-08-01,,INTERVENTIONAL,,,H-9926-LCH III: Treatment Protocol of the Third International Study for Langerhans Cell Histiocytosis,H-9926-LCH III: Treatment Protocol of the Third International Study for Langerhans Cell Histiocytosis,WITHDRAWN,,PHASE3,0.0,ACTUAL,University of New Mexico,,2.0,,This is a duplicate record and the sponsor has registered the study.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 20:01:34.26988,2024-10-15 20:01:34.26988,OTHER,,,,,,,2023,0.0
NCT01626833,,2012-06-21,,,2021-06-07,2012-06-21,2012-06-25,ESTIMATED,,,,,,,2021-06-07,2021-06-08,ACTUAL,2013-03,ACTUAL,2013-03-31,2021-05,2021-05-31,2021-03,ACTUAL,2021-03-31,2021-03,ACTUAL,2021-03-31,,INTERVENTIONAL,OREX,,Severe Decrease of Growth Velocity in Children With Anorexia Nervosa.Therapeutic Trial of Growth Hormone,Severe Decrease of Growth Velocity in Children With Anorexia Nervosa. Therapeutic Trial of Growth Hormone,COMPLETED,,PHASE2/PHASE3,15.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 20:01:34.26988,2024-10-15 20:01:34.26988,OTHER,,,,,,,2021,1.0
NCT03928743,,2019-04-23,2024-08-29,2022-09-01,2024-10-08,2019-04-23,2019-04-26,ACTUAL,2024-10-08,2024-10-10,ACTUAL,,2024-10-10,ACTUAL,2024-10-08,2024-10-10,ACTUAL,2019-04-25,ACTUAL,2019-04-25,2024-10,2024-10-31,2022-08-08,ACTUAL,2022-08-08,2021-09-03,ACTUAL,2021-09-03,,INTERVENTIONAL,BE MOBILE 2,Baseline Characteristics refer to the Safety Set which consisted of all randomized study participants who received at least one dose of the investigational medicinal product (IMP).,A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis,"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis",COMPLETED,,PHASE3,332.0,ACTUAL,UCB Pharma,,2.0,,,f,,,,t,t,f,,,f,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",http://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-15 20:01:34.26988,2024-10-15 20:01:34.26988,INDUSTRY,,,,,,,2022,1.0
NCT02913131,,2016-09-20,2022-03-24,,2022-03-24,2016-09-21,2016-09-23,ESTIMATED,2022-03-24,2022-04-22,ACTUAL,,,,2022-03-24,2022-04-22,ACTUAL,2016-10-20,ACTUAL,2016-10-20,2022-03,2022-03-31,2021-04-05,ACTUAL,2021-04-05,2021-04-05,ACTUAL,2021-04-05,,INTERVENTIONAL,,Two of the five participants enrolled in Part B were previously enrolled in Part A.,Hyperpolarized C-13 Pyruvate as a Biomarker in Patients With Advanced Solid Tumor Malignancies,Hyperpolarized C-13 Pyruvate as a Biomarker of PI3K/mTOR Pathway Inhibition in Patients With Advanced Solid Tumor Malignancies,TERMINATED,,PHASE1/PHASE2,23.0,ACTUAL,"University of California, San Francisco",The study was closed earlier than expected due to low enrollment in both cohorts.,2.0,,Low Accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,OTHER,,,,,,,2021,0.0
NCT04508842,,2020-08-09,,,2022-09-27,2020-08-10,2020-08-11,ACTUAL,,,,,,,2022-09-27,2022-09-28,ACTUAL,2020-10-10,ACTUAL,2020-10-10,2022-05,2022-05-31,2022-05-01,ACTUAL,2022-05-01,2022-05-01,ACTUAL,2022-05-01,,INTERVENTIONAL,,,CD19/CD22-Dual-STAR-T for Patients With B Cell Acute Leukemia(B-ALL),The Phase I Efficacy and Safety Clinical Study of CD19/CD22-Dual-STAR-T Cells in Relapsed and Refractory B-ALL.,TERMINATED,,PHASE1,2.0,ACTUAL,Hebei Yanda Ludaopei Hospital,,1.0,,Adjustment plan,f,,,,t,f,f,,,,,,,,,,,2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,OTHER,,,,,,,2022,0.0
NCT04371406,,2020-04-29,,,2020-10-23,2020-04-30,2020-05-01,ACTUAL,,,,,,,2020-10-23,2020-10-27,ACTUAL,2020-04,ESTIMATED,2020-04-30,2020-04,2020-04-30,2020-09,ESTIMATED,2020-09-30,2020-08,ESTIMATED,2020-08-31,,INTERVENTIONAL,MG-COVID,,Efficacy of Azithromycin-associated Hydroxychloroquine Therapy Given in General Practice in Early-stage Disease in COVID-19 Patients,Efficacy of Azithromycin-associated Hydroxychloroquine Therapy Given in General Practice in Early-stage Disease in COVID-19 Patients: Randomized Controlled Trial: MG-COVID,WITHDRAWN,,PHASE3,0.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,Regulatory approvals have not been obtained,f,,,,t,f,f,,,,,,Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor,Researchers who provide a methodological sound proposal.,,YES,"Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.~Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.",2024-10-15 20:01:34.26988,2024-10-15 20:01:34.26988,OTHER,,,,,,,2020,0.0
NCT04652479,,2020-10-27,2023-04-10,,2023-05-12,2020-12-02,2020-12-03,ACTUAL,2023-05-12,2023-06-09,ACTUAL,,,,2023-05-12,2023-06-09,ACTUAL,2021-06-21,ACTUAL,2021-06-21,2023-05,2023-05-31,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,Participants with no major protocol deviations who were allocated to treatment.,Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia,"A Phase 2, Open-Label, Cross-over Study to Assess the Safety and Efficacy of Avexitide in Acquired Hyperinsulinemic Hypoglycemia",COMPLETED,,PHASE2,25.0,ACTUAL,Stanford University,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,OTHER,,,,,,,2022,1.0
NCT05073458,,2021-09-28,,,2024-06-03,2021-09-29,2021-10-11,ACTUAL,,,,,,,2024-06-03,2024-06-04,ACTUAL,2022-03-15,ACTUAL,2022-03-15,2024-06,2024-06-30,2024-04-29,ACTUAL,2024-04-29,2023-10-17,ACTUAL,2023-10-17,,INTERVENTIONAL,PATHWAY,,Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia",TERMINATED,,PHASE3,13.0,ACTUAL,Incyte Corporation,,2.0,,A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.,f,,,,t,t,f,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,INDUSTRY,,,,,,,2024,0.0
NCT03352414,,2017-11-18,2021-04-13,,2021-07-19,2017-11-21,2017-11-24,ACTUAL,2021-06-28,2021-07-01,ACTUAL,,,,2021-07-19,2021-08-18,ACTUAL,2018-03-08,ACTUAL,2018-03-08,2021-07,2021-07-31,2020-04-28,ACTUAL,2020-04-28,2020-04-28,ACTUAL,2020-04-28,,INTERVENTIONAL,ILEUS,,Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC,The ILEUS Study: A Phase 2 Randomized Controlled Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy,TERMINATED,,PHASE2,84.0,ACTUAL,"University of California, San Diego",,2.0,,stopped by sponsor,f,,,,t,t,f,,,f,,,,,,NO,Study was terminated early,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER,,,,,,,2020,0.0
NCT04237792,,2020-01-17,2022-10-18,,2022-10-18,2020-01-17,2020-01-23,ACTUAL,2022-10-18,2022-11-16,ACTUAL,,,,2022-10-18,2022-11-16,ACTUAL,2020-02-18,ACTUAL,2020-02-18,2022-10,2022-10-31,2021-11-30,ACTUAL,2021-11-30,2021-11-02,ACTUAL,2021-11-02,,INTERVENTIONAL,,Full analysis set (FAS) included all randomized participants who received any amount of DEX.,Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans,"A PHASE 3/4 RANDOMIZED, DOUBLE-BLIND, DOSE-RANGING STUDY OF THE SAFETY AND EFFICACY OF DEXMEDETOMIDINE (DEX) USED WITH PROPOFOL (PRO) AS NEEDED FOR PROCEDURAL SEDATION OF PEDIATRIC SUBJECTS ≥1 MONTH TO <17 YEARS OF AGE UNDERGOING MRI SCANS",COMPLETED,,PHASE4,128.0,ACTUAL,Pfizer,,3.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 20:01:34.26988,2024-10-15 20:01:34.26988,INDUSTRY,,,,,,,2021,1.0
NCT03463889,,2018-02-09,2021-05-18,,2021-06-25,2018-03-06,2018-03-13,ACTUAL,2021-06-25,2021-06-29,ACTUAL,,,,2021-06-25,2021-06-29,ACTUAL,2018-03-19,ACTUAL,2018-03-19,2021-06,2021-06-30,2020-10-31,ACTUAL,2020-10-31,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,,,Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid Cancer,Gallium-68 Prostate Specific Membrane Antigen (68Ga-PSMA) PET for Imaging of Thyroid Cancer: A Feasibility Study,TERMINATED,,PHASE2,12.0,ACTUAL,"University of California, San Francisco","Study closed earlier than expected due to lack of funding. Due to the small sample size, comparative sub-group analyses could not be performed.",1.0,,Funding,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,OTHER,,,,,,,2020,0.0
NCT04351243,,2020-04-15,2021-11-26,,2021-12-10,2020-04-15,2020-04-17,ACTUAL,2021-12-06,2021-12-10,ACTUAL,,,,2021-12-10,2021-12-14,ACTUAL,2020-04-15,ACTUAL,2020-04-15,2021-12,2021-12-31,2021-04-01,ACTUAL,2021-04-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,,,A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE),"A Multi-Center, Adaptive, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)",COMPLETED,,PHASE2,227.0,ACTUAL,Kinevant Sciences GmbH,"The Sponsor stopped enrollment of subjects prior to achieving the planned sample size of 270. At the completion of study enrollment, 227 subjects were randomized and 225 received at least one dose of gimsilumab or placebo. All randomized subjects (227 subjects), where possible, completed all study-related activities and had data collected through the planned Day 43 and Day 169 analyses. No safety findings were observed which warranted study termination.",2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 20:01:34.26988,2024-10-15 20:01:34.26988,INDUSTRY,,,,,,,2021,1.0
NCT05179772,,2021-12-16,,,2023-01-30,2022-01-04,2022-01-05,ACTUAL,,,,,,,2023-01-30,2023-02-01,ACTUAL,2022-07-28,ACTUAL,2022-07-28,2023-01,2023-01-31,2023-01-30,ACTUAL,2023-01-30,2023-01-30,ACTUAL,2023-01-30,,INTERVENTIONAL,,,Olanzapine in OUD Patients,Olanzapine Augmentation of Buprenorphine-naloxone Treatment in OUD Patients With Comorbid Symptoms of Serious Mental Illness (SMI): A Prospective Open-label Single-arm 9-week Study,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Pennsylvania,,1.0,,NIDA has advised us to terminate this protocol due to the difficulties in finding appropriate subjects.,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 20:01:34.26988,2024-10-15 20:01:34.26988,OTHER,,,,,,,2023,0.0
NCT04328467,,2020-03-27,2021-06-25,,2021-06-30,2020-03-30,2020-03-31,ACTUAL,2021-06-25,2021-06-30,ACTUAL,,,,2021-06-30,2021-07-02,ACTUAL,2020-04-06,ACTUAL,2020-04-06,2021-06,2021-06-30,2020-07-13,ACTUAL,2020-07-13,2020-07-13,ACTUAL,2020-07-13,,INTERVENTIONAL,,,Pre-exposure Prophylaxis for SARS-Coronavirus-2,Pre-exposure Prophylaxis for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial,COMPLETED,,PHASE3,1483.0,ACTUAL,University of Minnesota,,3.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 20:01:34.26988,2024-10-15 20:01:34.26988,OTHER,,,,,,,2020,0.0
NCT02932475,,2016-05-17,2023-04-27,,2023-05-31,2016-10-11,2016-10-13,ESTIMATED,2023-04-27,2023-05-24,ACTUAL,,,,2023-05-31,2023-06-26,ACTUAL,2017-05-25,ACTUAL,2017-05-25,2023-04,2023-04-30,2022-06-15,ACTUAL,2022-06-15,2022-06-15,ACTUAL,2022-06-15,,INTERVENTIONAL,MOMPOD,,Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD),Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy,TERMINATED,,PHASE3,831.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,Recommendation by the DSMB that the study be stopped for futility,f,,,,t,t,f,,,,,,,,,YES,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER,,,,,,,2022,0.0
NCT02769130,,2016-05-09,,,2019-07-28,2016-05-09,2016-05-11,ESTIMATED,,,,,,,2019-07-28,2019-07-30,ACTUAL,2016-05,,2016-05-31,2019-07,2019-07-31,2021-05,ESTIMATED,2021-05-31,2021-05,ESTIMATED,2021-05-31,,INTERVENTIONAL,,,Pilot Trial: the Safety and Feasibility of Losartan for Pulmonary Vein Stenosis,Pilot Trial: the Safety and Feasibility of Losartan Therapy for Treatment of Pulmonary Vein Stenosis in Pediatric Patients,SUSPENDED,,PHASE1/PHASE2,40.0,ESTIMATED,The Hospital for Sick Children,,1.0,,"Due to Health Canada losartan recall, a new formulation being added to the protocol/ temporary suspension",f,,,,t,,,,,,,,,,,NO,,2024-10-15 20:01:34.26988,2024-10-15 20:01:34.26988,OTHER,,,,,,,2021,0.0
NCT04470089,,2020-05-19,,,2022-05-01,2020-07-12,2020-07-14,ACTUAL,,,,,,,2022-05-01,2022-05-05,ACTUAL,2020-02-18,ACTUAL,2020-02-18,2022-05,2022-05-31,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,MIRA1,,A Clinical Trial Investigating the Short-term Relief of Symptoms of Acute Pharyngitis by Treatment With Three Different Doses of MYRAMISTIN™ Oromucosal Spray,"A Multi-center, Randomized, Placebo-controlled, Double-blind, Dose-finding Clinical Trial Investigating the Short-term Relief of Symptoms of Acute Pharyngitis Such as Throat Soreness Pain and Difficulty to Swallow by Treatment With Three Different Doses of MYRAMISTIN™ Oromucosal Spray",TERMINATED,,PHASE2,170.0,ACTUAL,Megainpharm GmbH,,4.0,,Due to the COVID situation by end of 2021 and therfore limited recruitment of patients diagnosis acute pharyngitis the study was terminated.,f,,,,f,f,f,,,,,,,,,,,2024-10-15 20:01:34.26988,2024-10-15 20:01:34.26988,INDUSTRY,,,,,,,2021,0.0
NCT04543188,,2020-09-02,,,2024-05-20,2020-09-02,2020-09-10,ACTUAL,,,,,,,2024-05-20,2024-05-22,ACTUAL,2021-01-08,ACTUAL,2021-01-08,2024-05,2024-05-31,2024-03-20,ACTUAL,2024-03-20,2024-03-20,ACTUAL,2024-03-20,,INTERVENTIONAL,,,A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement,"A TWO-PART, PHASE 1A/B, OPEN-LABEL, MULTICENTER TRIAL EVALUATING PHARMACOKINETICS, SAFETY AND EFFICACY OF PF 07284890 (ARRY 461) IN PARTICIPANTS WITH BRAF V600 MUTANT SOLID TUMORS WITH AND WITHOUT BRAIN INVOLVEMENT",TERMINATED,,PHASE1,66.0,ACTUAL,Pfizer,,9.0,,Pfizer has made an internal business decision to not continue further development of PF-07284890. This decision was not due to major safety concerns or requests from any regulatory authorities.,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 20:01:34.26988,2024-10-15 20:01:34.26988,INDUSTRY,,,,,,,2024,0.0
NCT04392648,,2020-05-14,,,2020-07-10,2020-05-14,2020-05-19,ACTUAL,,,,,,,2020-07-10,2020-07-14,ACTUAL,2020-06-24,ESTIMATED,2020-06-24,2020-07,2020-07-31,2023-11-10,ESTIMATED,2023-11-10,2023-11-10,ESTIMATED,2023-11-10,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Tolerability and Efficacy of Intravenous TAK-573 as Part of Combination Therapy in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)","A Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Efficacy of Intravenous TAK-573 as Part of Combination Therapy in Patients With Relapsed or Refractory Multiple Myeloma",WITHDRAWN,,PHASE1,0.0,ACTUAL,Takeda,,6.0,,Business Decision (no enrollment),f,,,,f,t,f,,,,,,,,,YES,"Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",2024-10-15 20:01:34.26988,2024-10-15 20:01:34.26988,INDUSTRY,,,,,,,2023,0.0
NCT03970733,,2019-05-29,2021-05-05,,2023-03-24,2019-05-30,2019-05-31,ACTUAL,2021-07-06,2021-07-08,ACTUAL,,,,2023-03-24,2023-04-21,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2023-03,2023-03-31,2022-03-28,ACTUAL,2022-03-28,2020-04-07,ACTUAL,2020-04-07,,INTERVENTIONAL,,Safety population included all participants who entered into the study and received at least 1 dose of vaccination.,"Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis","ALTERNATIVE SCHEDULE STUDY FOR VLA15, A MULTIVALENT RECOMBINANT OSPA BASED VACCINE CANDIDATE AGAINST LYME BORRELIOSIS, IN HEALTHY ADULTS AGED 18 TO 65 YEARS - A RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE 2 STUDY.",COMPLETED,,PHASE2,246.0,ACTUAL,Pfizer,,3.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,INDUSTRY,,,,,,,2022,1.0
NCT03301766,,2017-09-29,,,2023-06-27,2017-09-29,2017-10-04,ACTUAL,,,,,,,2023-06-27,2023-06-29,ACTUAL,2017-03-10,ACTUAL,2017-03-10,2023-06,2023-06-30,2023-05-22,ACTUAL,2023-05-22,2023-05-22,ACTUAL,2023-05-22,,INTERVENTIONAL,,,Adjunctive 5% Lidocaine Patches for Acute Non-radicular Low Back Pain in Emergency Department Patients,Adjunctive 5% Lidocaine Patches in the Treatment of Acute Non-radicular Low Back Pain in Patients Discharged From the Emergency Department,WITHDRAWN,,PHASE4,0.0,ACTUAL,Cook County Health,,2.0,,Delay for subject recruitment and then not feasible with COVID\>,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER_GOV,,,,,,,2023,0.0
NCT05138549,,2021-10-28,,,2023-11-14,2021-11-16,2021-12-01,ACTUAL,,,,,,,2023-11-14,2023-11-18,ACTUAL,2022-09-02,ACTUAL,2022-09-02,2023-11,2023-11-30,2023-11-14,ACTUAL,2023-11-14,2023-11-14,ACTUAL,2023-11-14,,INTERVENTIONAL,,,Astaxanthin for Management of Inflammation in Knee Osteoarthritis,"Effect of Astaxanthin for Pain, Function, and Inflammation in Patients With Advanced Osteoarthritis Awaiting Total Knee Replacement Surgery",TERMINATED,,PHASE2/PHASE3,16.0,ACTUAL,Prisma Health-Midlands,,2.0,,There are not enough eligible patients at our institution to complete this study.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,OTHER,,,,,,,2023,0.0
NCT04387773,,2020-05-11,2024-07-26,,2024-09-17,2020-05-11,2020-05-14,ACTUAL,2024-09-17,2024-10-10,ACTUAL,,,,2024-09-17,2024-10-10,ACTUAL,2020-11-05,ACTUAL,2020-11-05,2024-09,2024-09-30,2022-09-30,ACTUAL,2022-09-30,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,,,"Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's Disease",Effect of GOCOVRI on Quantity and Quality of Gait in Parkinson's Disease,COMPLETED,,PHASE4,8.0,ACTUAL,Oregon Health and Science University,,1.0,,,f,,,,,t,f,,,f,,,3 months to 5 years after study publication,Requesters will need to sign a data access agreement.,,YES,"Individual participants' data will be available (including data dictionary) after de-identification and will include all data collected during the trial. The study protocol, statistical analysis plan, informed consent, clinical study report, and analytic code will all be available 3 months after study publication to 5 years after publication. This data will be shared with anyone providing a methodologically sound proposal. To gain access to the data proposals should be directed to carlsonp@ohsu.edu and requesters will need to sign a data access agreement.",2024-10-15 20:01:34.26988,2024-10-15 20:01:34.26988,OTHER,,,,,,,2022,1.0
NCT03630809,,2018-08-10,,,2022-04-15,2018-08-10,2018-08-15,ACTUAL,,,,,,,2022-04-15,2022-04-25,ACTUAL,2019-01-10,ACTUAL,2019-01-10,2022-04,2022-04-30,2022-04-11,ACTUAL,2022-04-11,2022-04-11,ACTUAL,2022-04-11,,INTERVENTIONAL,,,Immune Response and Potential Booster for Patients Who Have Received HER2-pulsed DC1,Immune Response Surveillance and Potential Booster Vaccines for Patients Who Have Received HER2-pulsed DC1 Vaccine,TERMINATED,,PHASE2,16.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,4.0,,Quality of the data originating from prior versions of the protocol has been affected by protocol deviations triggered by the COVID-19 pandemics,,,,,f,t,f,,,,,,,,,,,2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,OTHER,,,,,,,2022,0.0
NCT01988831,,2013-11-13,,,2019-05-09,2013-11-19,2013-11-20,ESTIMATED,,,,,,,2019-05-09,2019-05-10,ACTUAL,2016-06,,2016-06-30,2019-05,2019-05-31,2022-03,ESTIMATED,2022-03-31,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,,,Efficacy of Propranolol Treatment to Prevent Melanoma Progression,"Phase 2 Prospective Study of the Efficacy of Propranolol on Malignant Melanoma Progression. A Randomized Placebo-controlled,Single Blind Trial",SUSPENDED,,PHASE2,450.0,ESTIMATED,"University Hospital, Geneva",,2.0,,We must delay the study for some financial reasons,f,,,,f,,,,,,,,,,,,,2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,OTHER,,,,,,,2022,0.0
NCT04405180,,2019-04-15,2024-07-13,,2024-10-08,2020-05-26,2020-05-28,ACTUAL,2024-10-08,2024-10-10,ACTUAL,,,,2024-10-08,2024-10-10,ACTUAL,2021-04-23,ACTUAL,2021-04-23,2024-10,2024-10-31,2023-07-14,ACTUAL,2023-07-14,2023-07-14,ACTUAL,2023-07-14,,INTERVENTIONAL,Nitrite,,"Nitrites, Skeletal Muscle Mitochondrial Bioenergetics, and Physical Activity in Old Age","Nitrites, Skeletal Muscle Mitochondrial Bioenergetics, and Physical Activity in Old Age",COMPLETED,,PHASE2,64.0,ACTUAL,University of Pittsburgh,"Departures from the muscle preservation protocol resulted in widespread ice artifact in the majority of mounted tissue samples. Nearly all muscle samples are non-viable for histological and morphological analyses. Consequently, skeletal muscle histological and morphological outcomes (cross sectional area, fiber type, fiber type area, and mitochondrial content) were omitted due to to technical limitations and predominant doubts regarding the reliability of the data.",2.0,,,f,,,,t,t,f,,,f,,,A limit in time frame of sharing has not been defined.,Only de-identified data approved for sharing by PI.,,YES,De-Identified data may be shared with other future investigators as research questions arise.,2024-10-15 20:01:34.26988,2024-10-15 20:01:34.26988,OTHER,,,,,,,2023,1.0
NCT05295927,,2022-03-24,,,2023-05-08,2022-03-24,2022-03-25,ACTUAL,,,,,,,2023-05-08,2023-05-09,ACTUAL,2022-03-23,ACTUAL,2022-03-23,2023-05,2023-05-31,2022-09-30,ACTUAL,2022-09-30,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,,,"A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)",A Phase 1b Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone or Apalutamide in mCRPC (ARES: Androgen Receptor Eradication Study),TERMINATED,,PHASE1,3.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,Administrative Decision,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,INDUSTRY,,,,,,,2022,0.0
NCT05240560,,2022-01-20,,,2024-08-08,2022-02-14,2022-02-15,ACTUAL,,,,,,,2024-08-08,2024-08-09,ACTUAL,2023-01-20,ACTUAL,2023-01-20,2024-08,2024-08-31,2024-02-08,ACTUAL,2024-02-08,2024-02-08,ACTUAL,2024-02-08,,INTERVENTIONAL,,,Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke,A Multisite Randomized Clinical Trial Evaluating Efficacy and Safety of BP1.3656 vs Placebo in Patients With Fatigue Following Ischemic Stroke,TERMINATED,,PHASE2,5.0,ACTUAL,Bioprojet,,2.0,,Lack of recruitment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,OTHER,,,,,,,2024,0.0
NCT04279561,,2020-02-19,,,2022-09-19,2020-02-19,2020-02-21,ACTUAL,,,,,,,2022-09-19,2022-09-21,ACTUAL,2020-04-16,ACTUAL,2020-04-16,2022-09,2022-09-30,2022-09-15,ACTUAL,2022-09-15,2022-09-15,ACTUAL,2022-09-15,,INTERVENTIONAL,,,Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Castration-Resistant Prostate Cancer,Effects of Novel Androgen Receptor Signaling Inhibitors on PSMA PET Signal Intensity in Patients With Castrate-Resistant Prostate Cancer: A Prospective Exploratory Study,TERMINATED,,PHASE1,9.0,ACTUAL,Jonsson Comprehensive Cancer Center,,1.0,,slow accrual,,,,,t,t,f,,,f,,,,,,,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER,,,,,,,2022,0.0
NCT04390594,,2020-05-14,,,2024-06-18,2020-05-14,2020-05-15,ACTUAL,,,,,,,2024-06-18,2024-06-21,ACTUAL,2020-08-13,ACTUAL,2020-08-13,2020-09,2020-09-30,2023-02-08,ACTUAL,2023-02-08,2023-02-08,ACTUAL,2023-02-08,,INTERVENTIONAL,SEN-CoV-Fadj,,Efficacy and Safety Evaluation of Treatment Regimens in Adult COVID-19 Patients in Senegal,"Multicentre, Open Label, Randomised, Adaptative Clinical Trial of Efficacy and Safety of Treatment Regimens in Adult COVID-19 Patients in Senegal",TERMINATED,,PHASE3,59.0,ACTUAL,Institut Pasteur de Dakar,,2.0,,"In conclusion, the results of the SEN-CoV Fadj trial to date do not meet the objectives of the clinical trial and the sample size required to meet them is clearly too large to be achieved within a reasonable time.",f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,OTHER,,,,,,,2023,0.0
NCT05474690,,2022-05-17,,,2024-02-23,2022-07-24,2022-07-26,ACTUAL,,,,,,,2024-02-23,2024-02-26,ACTUAL,2022-05-11,ACTUAL,2022-05-11,2024-02,2024-02-29,2024-08-30,ESTIMATED,2024-08-30,2023-03-28,ACTUAL,2023-03-28,,INTERVENTIONAL,,,A Study Comparing the Efficacy of TCbHP and ECHP-THP in the Neoadjuvant Treatment of HER2-positive Breast Cancer,"A Non-inferior, Randomized Controlled Phase III Clinical Study Comparing the Efficacy of TCbHPand ECHP-THP in Neoadjuvant Treatment of Operable HER2-positive Breast Cancer",WITHDRAWN,,PHASE3,0.0,ACTUAL,Henan Cancer Hospital,,2.0,,"The new treatment plan for HER2 positive breast cancer has entered the diagnosis and treatment guide. The treatment plan ECHP-THP in this study is not the optimal treatment plan, therefore this study was terminated.",f,,,,t,f,f,,,,,,,,,,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER_GOV,,,,,,,2024,0.0
NCT03803254,,2019-01-11,,,2019-05-02,2019-01-11,2019-01-14,ACTUAL,,,,,,,2019-05-02,2019-05-06,ACTUAL,2019-01-03,ACTUAL,2019-01-03,2019-01,2019-01-31,2021-01-01,ESTIMATED,2021-01-01,2021-01-01,ESTIMATED,2021-01-01,,INTERVENTIONAL,,,HAIC Plus Lenvatinib and PD-1 Antibody Versus HAIC Plus Lenvatinib for Advanced HCC,Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and Programmed Cell Death Protein-1 Antibody Versus Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib for Advanced Hepatocellular Carcinoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,Sun Yat-sen University,,2.0,,No participants enrolled,f,,,,t,f,f,,,,,,,,,,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,OTHER,,,,,,,2021,0.0
NCT03165721,,2017-05-23,2020-11-30,,2022-03-15,2017-05-23,2017-05-24,ACTUAL,2021-04-12,2021-05-10,ACTUAL,,,,2022-03-15,2022-04-05,ACTUAL,2017-08-16,ACTUAL,2017-08-16,2022-03,2022-03-31,2020-02-24,ACTUAL,2020-02-24,2020-02-24,ACTUAL,2020-02-24,,INTERVENTIONAL,,,"A Phase II Trial of the DNA Methyl Transferase Inhibitor, Guadecitabine (SGI-110), in Children and Adults With Wild Type GIST,Pheochromocytoma and Paraganglioma Associated With Succinate Dehydrogenase Deficiency and HLRCC-associated Kidney Cancer","A Phase II Trial of the DNA Methyl Transferase Inhibitor, SGI-110 (Guadecitabine), In Children And Adults With Wild Type GIST, Pheochromocytoma And Paraganglioma Associated With Succinate Dehydrogenase Deficiency And HLRCC-Associated Kidney Cancer",TERMINATED,,PHASE2,9.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,Study closed to enrollment due to low accrual.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,NIH,,,,,,,2020,0.0
NCT04684550,,2020-12-21,,,2023-03-01,2020-12-23,2020-12-24,ACTUAL,,,,,,,2023-03-01,2023-03-03,ACTUAL,2021-02-15,ESTIMATED,2021-02-15,2023-03,2023-03-31,2021-08-15,ESTIMATED,2021-08-15,2021-06-15,ESTIMATED,2021-06-15,,INTERVENTIONAL,,,Use of Hypochlorous Acid as Prophylaxis in Health Personnel at High Risk of Infection by SARS-CoV 2 (COVID19),Randomized Controlled Clinical Study (RCT) Phase 3 of the Safety and Efficacy of Hypochlorous Acid in the Prophylaxis of Healthcare Personnel at High Risk of Infection by SARS-CoV2 (COVID19) Versus Placebo,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Hospital Universitario San Ignacio,,2.0,,"The study did not achieve funding or approval by the ethics committee. Once the vaccination phase was entered, the study lost validity and was not viable",f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER,,,,,,,2021,0.0
NCT02939742,,2016-09-23,,,2024-01-24,2016-10-17,2016-10-20,ESTIMATED,,,,,,,2024-01-24,2024-01-26,ACTUAL,2016-11,,2016-11-30,2024-01,2024-01-31,2023-12-20,ACTUAL,2023-12-20,2023-12-20,ACTUAL,2023-12-20,,INTERVENTIONAL,,,Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity?,Does a Repeat Course of Antenatal Corticosteroids in Pregnant Women With Preterm Premature Rupture of Membranes Decrease Neonatal Morbidity?,TERMINATED,,PHASE2/PHASE3,33.0,ACTUAL,"The University of Texas Medical Branch, Galveston",,2.0,,Low study recruitment,f,,,,f,,f,,,,,,,,,NO,,2024-10-15 20:01:34.26988,2024-10-15 20:01:34.26988,OTHER,,,,,,,2023,0.0
NCT02856581,,2016-08-01,2022-05-31,,2022-06-30,2016-08-02,2016-08-05,ESTIMATED,2022-05-31,2022-06-24,ACTUAL,,,,2022-06-30,2022-07-27,ACTUAL,2017-09-29,ACTUAL,2017-09-29,2022-06,2022-06-30,2022-04-15,ACTUAL,2022-04-15,2021-05-28,ACTUAL,2021-05-28,,INTERVENTIONAL,,,Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes,Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes,TERMINATED,,PHASE3,23.0,ACTUAL,Alliance for Clinical Trials in Oncology,,2.0,,Slow accrual,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER,,,,,,,2022,0.0
NCT04100096,,2019-09-20,2024-06-25,2022-06-27,2024-06-25,2019-09-20,2019-09-24,ACTUAL,2024-06-25,2024-07-18,ACTUAL,2022-06-27,2022-06-29,ACTUAL,2024-06-25,2024-07-18,ACTUAL,2019-10-17,ACTUAL,2019-10-17,2024-06,2024-06-30,2021-06-27,ACTUAL,2021-06-27,2021-06-27,ACTUAL,2021-06-27,,INTERVENTIONAL,,Randomized population included all participants who were randomized to receive brexpiprazole or matching placebo in the treatment phase.,A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder,"A Multicenter, Randomized, Flexible-dose, Double-blind Trial of Brexpiprazole Versus Placebo for the Treatment of Adults With Borderline Personality Disorder",COMPLETED,,PHASE2,332.0,ACTUAL,"Otsuka Pharmaceutical Development & Commercialization, Inc.",,2.0,,,f,,,,f,t,f,,,,,,"Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.",Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/,https://clinical-trials.otsuka.com,YES,Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,INDUSTRY,,,,,,,2021,1.0
NCT03259334,,2017-08-21,2021-04-12,,2021-06-07,2017-08-22,2017-08-23,ACTUAL,2021-04-12,2021-05-07,ACTUAL,,,,2021-06-07,2021-06-14,ACTUAL,2018-02-09,ACTUAL,2018-02-09,2021-06,2021-06-30,2020-10-23,ACTUAL,2020-10-23,2020-07-22,ACTUAL,2020-07-22,,INTERVENTIONAL,FIGARO UC 301,The safety set consisted of all participants who had received at least 1 dose of investigational product.,Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis,"A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 301)",TERMINATED,,PHASE3,380.0,ACTUAL,Takeda,The study was terminated early as per the sponsor decision to discontinue the ontamalimab clinical trial development program for inflammatory bowel diseases (IBD) for reasons unrelated to safety and efficacy.,3.0,,Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,INDUSTRY,,,,,,,2020,0.0
NCT03927248,,2019-04-23,,,2020-05-05,2019-04-23,2019-04-25,ACTUAL,,,,,,,2020-05-05,2020-05-07,ACTUAL,2020-09,ESTIMATED,2020-09-30,2020-04,2020-04-30,2021-12,ESTIMATED,2021-12-31,2021-09,ESTIMATED,2021-09-30,,INTERVENTIONAL,,,"PAC-1 for Treatment of Refractory, Metastatic Kidney Cancer",Pilot Study of Nivolumab and Procaspase Activating Compound-1 (PAC-1) for,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,HealthPartners Institute,,1.0,,funding issues,f,,,,f,t,f,,,,,,,,,,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER,,,,,,,2021,0.0
NCT04357353,,2020-04-19,,,2023-08-25,2020-04-19,2020-04-22,ACTUAL,,,,,,,2023-08-25,2023-08-29,ACTUAL,2021-04-01,ACTUAL,2021-04-01,2023-08,2023-08-31,2022-11-02,ACTUAL,2022-11-02,2022-11-02,ACTUAL,2022-11-02,,INTERVENTIONAL,,,The Role of Platelet Rich Plasma for Erectile Dysfunction,The Role of Platelet Rich Plasma for Erectile Dysfunction,TERMINATED,,PHASE3,13.0,ACTUAL,University of Nebraska,,2.0,,low enrollment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER,,,,,,,2022,0.0
NCT05039710,,2021-09-01,,,2023-05-12,2021-09-01,2021-09-09,ACTUAL,,,,,,,2023-05-12,2023-05-16,ACTUAL,2021-11-08,ACTUAL,2021-11-08,2023-05,2023-05-31,2023-02-22,ACTUAL,2023-02-22,2023-02-17,ACTUAL,2023-02-17,,INTERVENTIONAL,,,A Study of JNJ-75220795 in Japanese Participants,"A Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered JNJ-75220795 in Japanese Participants",TERMINATED,,PHASE1,9.0,ACTUAL,Janssen Pharmaceutical K.K.,,2.0,,Business Judgement,f,,,,t,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,INDUSTRY,,,,,,,2023,0.0
NCT01341652,,2011-03-24,2020-10-30,,2021-01-15,2011-04-22,2011-04-26,ESTIMATED,2020-10-30,2020-11-25,ACTUAL,,,,2021-01-15,2021-01-20,ACTUAL,2011-05-23,ACTUAL,2011-05-23,2021-01,2021-01-31,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,Baseline characteristics include those who completed the study.,Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer,Randomized Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) Versus GM-CSF Adjuvant in Patients With Non-Metastatic Prostate Cancer,COMPLETED,,PHASE2,99.0,ACTUAL,"University of Wisconsin, Madison",,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER,,,,,,,2020,1.0
NCT05118386,,2021-10-06,2023-12-01,,2023-12-01,2021-11-11,2021-11-12,ACTUAL,2023-12-01,2024-05-20,ACTUAL,,,,2023-12-01,2024-05-20,ACTUAL,2021-11-16,ACTUAL,2021-11-16,2023-12,2023-12-31,2022-12-07,ACTUAL,2022-12-07,2022-08-23,ACTUAL,2022-08-23,,INTERVENTIONAL,,Safety Population: included all participants who received the study treatment.,"Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults","A Phase 1 Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of RSM01, a Monoclonal Antibody Targeting Respiratory Syncytial Virus, in Healthy Adults",COMPLETED,,PHASE1,56.0,ACTUAL,Bill & Melinda Gates Medical Research Institute,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Anonymized or deidentified, as appropriate, participant level data may be shared with external researchers in accordance with the trial participants' written and executed informed consent document and any local or applicable regulations on data sharing. Qualified researchers may submit a request for anonymized or de-identified participant level data along with a research proposal to Gates MRI for review. A data sharing agreement must be in place before any clinical trial data are shared. There are additional circumstances that may prevent the sharing of data with external researchers, including but not limited to contractual obligations to existing partners and any restrictions imposed by regulatory bodies.",2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER,,,,,,,2022,1.0
NCT04653818,,2020-11-28,,,2023-03-31,2020-11-28,2020-12-04,ACTUAL,,,,,,,2023-03-31,2023-04-04,ACTUAL,2020-10-05,ACTUAL,2020-10-05,2023-03,2023-03-31,2022-10-24,ACTUAL,2022-10-24,2022-10-24,ACTUAL,2022-10-24,,INTERVENTIONAL,RCT,,HCV Related Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial,Does Directly Acting Antivirals Usage Affect HCV Related Hepatocellular Carcinoma Recurrence After Percutaneous Ablation: A Randomized Controlled Trial,COMPLETED,,PHASE4,84.0,ACTUAL,Alexandria University,,2.0,,,f,,,,,f,f,,,f,,,,,,YES,,2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,OTHER,,,,,,,2022,1.0
NCT04824131,,2021-01-06,2024-02-28,,2024-07-26,2021-03-26,2021-04-01,ACTUAL,2024-07-26,2024-07-30,ACTUAL,,,,2024-07-26,2024-07-30,ACTUAL,2020-11-04,ACTUAL,2020-11-04,2024-07,2024-07-31,2023-01-10,ACTUAL,2023-01-10,2023-01-10,ACTUAL,2023-01-10,,INTERVENTIONAL,,Includes all enrolled participants,"Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females","Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females - A Sub-study of HPTN 084",COMPLETED,,PHASE2,55.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,NIH,,,,,,,2023,1.0
NCT03060447,,2017-02-17,2021-02-10,,2021-03-29,2017-02-17,2017-02-23,ACTUAL,2021-03-29,2021-04-21,ACTUAL,,,,2021-03-29,2021-04-21,ACTUAL,2017-05-09,ACTUAL,2017-05-09,2021-03,2021-03-31,2020-02-13,ACTUAL,2020-02-13,2020-02-13,ACTUAL,2020-02-13,,INTERVENTIONAL,,The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.,Study to Evaluate the Safety and Efficacy of Vesatolimod in Antiretroviral Treated Human Immunodeficiency Virus (HIV-1) Infected Controllers,"A Phase 1b, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of GS-9620 in Antiretroviral Treated HIV-1 Infected Controllers",COMPLETED,,PHASE1,25.0,ACTUAL,Gilead Sciences,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,INDUSTRY,,,,,,,2020,1.0
NCT01679080,,2012-08-16,,,2021-06-22,2012-08-30,2012-09-05,ESTIMATED,,,,,,,2021-06-22,2021-06-25,ACTUAL,2012-11,,2012-11-30,2021-06,2021-06-30,2021-06-01,ACTUAL,2021-06-01,2020-07-01,ACTUAL,2020-07-01,,INTERVENTIONAL,,,The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta,The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta,TERMINATED,,PHASE2,9.0,ACTUAL,University of Aarhus,,3.0,,Eli Lilly has withdrawn support to the study of teriparatide and placebo pens. The study was not able to continue as a randomized study without the supply of placebo pens.,f,,,,f,,,,,,,,,,,,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER,,,,,,,2021,0.0
NCT02993224,,2016-11-08,2021-09-06,,2021-09-06,2016-12-12,2016-12-15,ESTIMATED,2021-09-06,2021-10-04,ACTUAL,,,,2021-09-06,2021-10-04,ACTUAL,2017-07-27,ACTUAL,2017-07-27,2021-09,2021-09-30,2021-03-11,ACTUAL,2021-03-11,2020-01-29,ACTUAL,2020-01-29,,INTERVENTIONAL,Jupiter,,"Open-label, Multicenter Study Assessing Preference for Deferasirox Film-coated Tablet Compared to Dispersible Tablet","Open-label, Multicenter, Single Arm, Phase II Study Assessing Treatment Patient Preference for New Deferasirox Formulation (Film-coated Tablet) Compared to the Reference Deferasirox Dispersible Tablet Formulation",COMPLETED,,PHASE2,148.0,ACTUAL,Novartis,,1.0,,,f,,,,f,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,INDUSTRY,,,,,,,2021,1.0
NCT02380352,,2015-03-02,,,2021-05-27,2015-03-04,2015-03-05,ESTIMATED,,,,,,,2021-05-27,2021-06-08,ACTUAL,2016-09,,2016-09-30,2021-05,2021-05-31,2020-04,ACTUAL,2020-04-30,2019-12,ACTUAL,2019-12-31,,INTERVENTIONAL,SAFER,,Short-course Antimicrobial Therapy for Paediatric Respiratory Infections,Short-course Antimicrobial Therapy for Paediatric Respiratory Infections,COMPLETED,,PHASE4,281.0,ACTUAL,Hamilton Health Sciences Corporation,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER,,,,,,,2020,1.0
NCT02654587,,2016-01-08,2023-10-30,,2024-01-31,2016-01-12,2016-01-13,ESTIMATED,2024-01-31,2024-02-02,ACTUAL,,,,2024-01-31,2024-02-02,ACTUAL,2016-02-12,ACTUAL,2016-02-12,2024-01,2024-01-31,2021-01-15,ACTUAL,2021-01-15,2021-01-15,ACTUAL,2021-01-15,,INTERVENTIONAL,ATALANTE-1,219 HLA-A2 positive patients with advanced NSCLC who progressed after sequential or concurrent chemotherapy and Immune Checkpoint Inhibitor (either primary or secondary resistance) were randomized. Safety analysis was done in overall population. Primary efficacy analysis was carried out from stratification factor in subgroup of patients with ICI secondary resistance (who had a disease progression after ICI second line \> or equal to 12 weeks),OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure,A Randomized Phase III Trial of OSE2101 Compared With Chemotherapy (Docetaxel or Pemetrexed) in HLA-A2 Positive Patients With Advanced Non-Small Cell Lung Cancer With Progressive Disease After Immune Checkpoint Inhibitors,TERMINATED,,PHASE3,219.0,ACTUAL,OSE Immunotherapeutics,"In April 2020 at time of planned interim analysis, decision was taken to prematurely stop the accrual due to COVID-19. Early termination led to small numbers of subject analyzed. The statistical plan was revised to propose the primary efficacy analysis in subgroup of patients with ICI secondary resistance (defined as progression after ICI second line \>= to 12 weeks from stratification criteria based on biological and clinical rationale).",2.0,,due to COVID-19,f,,,,t,,,,,,,,,,,NO,"The supporting information as Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR) may be shared with other researchers if OSE Immunotherapeutics agreed and after signature of a confidential agreement between the parties",2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,INDUSTRY,,,,,,,2021,0.0
NCT03637803,,2018-08-03,,,2023-05-30,2018-08-16,2018-08-20,ACTUAL,,,,,,,2023-05-30,2023-06-01,ACTUAL,2019-01-10,ACTUAL,2019-01-10,2023-05,2023-05-31,2023-05-08,ACTUAL,2023-05-08,2023-05-08,ACTUAL,2023-05-08,,INTERVENTIONAL,,,Live Biotherapeutic Product MRx0518 and Pembrolizumab Combination Study in Solid Tumors,"A Phase I/II Open Label, Safety And Preliminary Efficacy Study of MRx0518 In Combination With Pembrolizumab In Patients With Advanced Malignancies Who Have Progressed On PD-1/PD-L1 Inhibitors",TERMINATED,,PHASE1/PHASE2,63.0,ACTUAL,4D pharma plc,,1.0,,Sponsor insolvency,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,INDUSTRY,,,,,,,2023,0.0
NCT04875806,,2021-05-03,,,2024-06-26,2021-05-05,2021-05-06,ACTUAL,,,,,,,2024-06-26,2024-06-27,ACTUAL,2021-06-30,ACTUAL,2021-06-30,2024-06,2024-06-30,2024-01-30,ACTUAL,2024-01-30,2024-01-30,ACTUAL,2024-01-30,,INTERVENTIONAL,,,A Safety and Tolerability Study of NC762 in Subjects With Advanced or Metastatic Solid Tumors,"A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC762 in Subjects With Advanced or Metastatic Solid Tumors",TERMINATED,,PHASE1/PHASE2,40.0,ACTUAL,"NextCure, Inc.",,5.0,,"Due to the limited activity in Phase 1, NextCure decided to discontinue development of the anti-B7-H4 antibody monotherapy trial (NC762-01) to move forward with a prioritized B7-H4 ADC program.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 20:03:57.559875,2024-10-15 20:03:57.559875,INDUSTRY,,,,,,,2024,0.0
NCT04875039,,2021-04-27,,,2022-03-03,2021-04-30,2021-05-06,ACTUAL,,,,,,,2022-03-03,2022-03-04,ACTUAL,2021-08-31,ACTUAL,2021-08-31,2022-03,2022-03-31,2022-03-01,ACTUAL,2022-03-01,2022-03-01,ACTUAL,2022-03-01,,INTERVENTIONAL,,,Dexametasone Versus Dexametasone Plus Dexmedetomidine in Nerve Blocks,A Randomized Comparison Between Perineural Dexamethasone and Perineural Mixture of Dexamethasone-Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Block,COMPLETED,,PHASE4,50.0,ACTUAL,University of Chile,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER,,,,,,,2022,1.0
NCT04665921,,2020-12-07,,,2024-03-15,2020-12-07,2020-12-14,ACTUAL,,,,,,,2024-03-15,2024-03-19,ACTUAL,2021-01-18,ACTUAL,2021-01-18,2024-03,2024-03-31,2024-03-01,ACTUAL,2024-03-01,2024-03-01,ACTUAL,2024-03-01,,INTERVENTIONAL,,,A Study of SGN-STNV in Advanced Solid Tumors,A Phase 1 Study of SGN-STNV in Advanced Solid Tumors,TERMINATED,,PHASE1,111.0,ACTUAL,Seagen Inc.,,1.0,,Study closed due to portfolio prioritization,f,,,,f,t,f,,,,,,,,,,,2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,INDUSTRY,,,,,,,2024,0.0
NCT03144583,,2017-04-26,,,2023-08-25,2017-05-04,2017-05-09,ACTUAL,,,,,,,2023-08-25,2023-08-28,ACTUAL,2017-06-15,ACTUAL,2017-06-15,2023-08,2023-08-31,2022-09-13,ACTUAL,2022-09-13,2022-09-13,ACTUAL,2022-09-13,,INTERVENTIONAL,CART19-BE-01,,Pilot Study on the Infusion of ARI-0001 Cells in Patients With CD19+ Leukemia or Lymphoma Refractory to Therapy,"Pilot Study on the Infusion of Differentiated Autologous T-cells From Peripheral Blood, Expanded and Transduced With a Lentivirus to Express a Chimeric Antigen Receptor With Anti-CD19 Specificity Conjugated With the Co-stimulatory Regions 4-1BB and CD3z in Patients With CD19+ Leukemia or Lymphoma Refractory to Therapy",COMPLETED,,PHASE1,50.0,ACTUAL,Institut d'Investigacions Biomèdiques August Pi i Sunyer,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER,,,,,,,2022,1.0
NCT02607956,,2015-11-10,2018-05-03,,2022-02-10,2015-11-16,2015-11-18,ESTIMATED,2018-05-03,2018-06-06,ACTUAL,,,,2022-02-10,2022-03-07,ACTUAL,2015-11-11,ACTUAL,2015-11-11,2022-02,2022-02-28,2021-07-05,ACTUAL,2021-07-05,2017-05-12,ACTUAL,2017-05-12,,INTERVENTIONAL,,Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of the study drug.,"Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults","A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults",COMPLETED,,PHASE3,657.0,ACTUAL,Gilead Sciences,,4.0,,,f,,,,t,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy",2024-10-15 20:03:57.559875,2024-10-15 20:03:57.559875,INDUSTRY,,,,,,,2021,1.0
NCT03762122,,2018-11-30,,,2022-11-04,2018-11-30,2018-12-03,ACTUAL,,,,,,,2022-11-04,2022-11-09,ACTUAL,2019-07-25,ACTUAL,2019-07-25,2022-11,2022-11-30,2021-08-24,ACTUAL,2021-08-24,2021-08-13,ACTUAL,2021-08-13,,INTERVENTIONAL,,,Rogaratinib in Patients With Advanced Pretreated Squamous-cell Non-small Cell Lung Cancer (SQCLC),"Fibroblast Growth Factor Receptor (FGFR) Inhibitor Rogaratinib in Patients With Advanced Pretreated Squamous-cell Non-small Cell Lung Cancer (SQCLC) Overexpressing FGFR mRNA. A Multicenter, Single Arm Phase II Trial",TERMINATED,,PHASE2,15.0,ACTUAL,Swiss Group for Clinical Cancer Research,,1.0,,Due to financial restructure of SAKK,f,,,,t,f,f,,,,,,,,,,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER,,,,,,,2021,0.0
NCT04220489,,2019-11-21,2023-11-21,,2024-01-03,2020-01-06,2020-01-07,ACTUAL,2024-01-03,2024-01-30,ACTUAL,,,,2024-01-03,2024-01-30,ACTUAL,2019-12-17,ACTUAL,2019-12-17,2024-01,2024-01-31,2022-11-19,ACTUAL,2022-11-19,2022-11-19,ACTUAL,2022-11-19,,INTERVENTIONAL,,Only one subject was enrolled into this trial and they were in the ketamine group,Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery,"Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery: A Randomized, Double-blind, Placebo-controlled Trial",TERMINATED,,PHASE2,1.0,ACTUAL,University of Pittsburgh,,2.0,,Study stopped due to unexpected issues surrounding the 2020 COVID-19 pandemic,f,,,,t,t,f,,,,,,,,,NO,"There is no current plan to share individual participant data. In the future, the investigators may decide to share data with other investigators both within and outside of this institution. If that were to occur, we would de-identify all of the information prior to sharing any data in this way.",2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER,,,,,,,2022,0.0
NCT04191577,,2019-10-30,2023-06-28,,2024-06-11,2019-12-04,2019-12-10,ACTUAL,2024-06-11,2024-07-03,ACTUAL,,,,2024-06-11,2024-07-03,ACTUAL,2019-12-02,ACTUAL,2019-12-02,2024-06,2024-06-30,2021-12-13,ACTUAL,2021-12-13,2021-11-06,ACTUAL,2021-11-06,,INTERVENTIONAL,,"Safety Analysis Set comprised of all participants who were enrolled and received at least 1 dose of study drug, classified according to the treatment they actually received.",Study of CVN424 in Parkinson's Disease Patients With Motor Fluctuations,"A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of CVN424 in Parkinson's Disease Patients With Motor Fluctuations",COMPLETED,,PHASE2,136.0,ACTUAL,Cerevance,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,INDUSTRY,,,,,,,2021,1.0
NCT03158688,,2017-05-09,2020-07-13,,2024-05-10,2017-05-16,2017-05-18,ACTUAL,2020-08-21,2020-09-11,ACTUAL,,,,2024-05-10,2024-05-14,ACTUAL,2017-06-13,ACTUAL,2017-06-13,2024-05,2024-05-31,2022-04-15,ACTUAL,2022-04-15,2019-07-14,ACTUAL,2019-07-14,,INTERVENTIONAL,CANDOR,Intent to Treat population,"Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma.","A Randomized, Open-label, Phase 3 Study Comparing Carfilzomib, Dexamethasone, and Daratumumab to Carfilzomib and Dexamethasone for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma",COMPLETED,,PHASE3,466.0,ACTUAL,Amgen,,2.0,,,f,,,,t,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,INDUSTRY,,,,,,,2022,1.0
NCT04265274,,2020-02-05,,,2023-10-03,2020-02-09,2020-02-11,ACTUAL,,,,,,,2023-10-03,2023-10-06,ACTUAL,2020-01-01,ACTUAL,2020-01-01,2023-10,2023-10-31,2023-01-01,ACTUAL,2023-01-01,2022-01-01,ACTUAL,2022-01-01,,INTERVENTIONAL,,,"Vinorelbine, Cisplatin, Disulfiram and Copper in CTC_EMT Positive Refractory Metastatic Breast Cancer.","Phase II Study of Vinorelbine, Cisplatin, Disulfiram and Copper in CTC_EMT Positive Refractory Metastatic Breast Cancer.",WITHDRAWN,,PHASE2,0.0,ACTUAL,"National Cancer Institute, Slovakia",,1.0,,Poor acrual,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,OTHER_GOV,,,,,,,2023,0.0
NCT03720470,,2018-10-24,2020-12-21,,2020-12-21,2018-10-24,2018-10-25,ACTUAL,2020-12-21,2021-01-19,ACTUAL,,,,2020-12-21,2021-01-19,ACTUAL,2018-10-29,ACTUAL,2018-10-29,2020-12,2020-12-31,2020-03-06,ACTUAL,2020-03-06,2019-12-27,ACTUAL,2019-12-27,,INTERVENTIONAL,JADE Compare,Safety analysis set included all randomized participants who received at least 1 dose of study medication.,Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy,"A PHASE 3 RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 AND DUPILUMAB IN COMPARISON WITH PLACEBO IN ADULT SUBJECTS ON BACKGROUND TOPICAL THERAPY, WITH MODERATE TO SEVERE ATOPIC DERMATITIS",COMPLETED,,PHASE3,838.0,ACTUAL,Pfizer,,5.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 10:41:11.172317,2024-10-15 10:41:11.172317,INDUSTRY,,,,,,,2020,1.0
NCT04635696,,2020-11-13,,,2021-03-09,2020-11-13,2020-11-19,ACTUAL,,,,,,,2021-03-09,2021-03-12,ACTUAL,2019-01-07,ACTUAL,2019-01-07,2021-03,2021-03-31,2020-12-10,ACTUAL,2020-12-10,2020-12-10,ACTUAL,2020-12-10,,INTERVENTIONAL,,,Ethyl Chloride for NPWT,Evaluating the Efficacy of Ethyl Chloride on Patients' Reported Pain With Negative Pressure Wound Therapy,COMPLETED,,PHASE4,100.0,ACTUAL,ProMedica Health System,,2.0,,,f,,,,f,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,OTHER,,,,,,,2020,1.0
NCT04360187,,2020-04-04,2022-04-03,,2022-05-12,2020-04-21,2020-04-24,ACTUAL,2022-04-03,2022-05-02,ACTUAL,,,,2022-05-12,2022-06-07,ACTUAL,2020-07-27,ACTUAL,2020-07-27,2022-05,2022-05-31,2021-09-08,ACTUAL,2021-09-08,2021-09-08,ACTUAL,2021-09-08,,INTERVENTIONAL,,Safety Analysis Set included all participants who were randomized and received at least 1 confirmed dose of investigational product.,Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis,"A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CRISABOROLE OINTMENT, 2% IN CHINESE AND JAPANESE PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS",COMPLETED,,PHASE3,391.0,ACTUAL,Pfizer,,2.0,,,f,,,,,t,f,,,t,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,INDUSTRY,,,,,,,2021,1.0
NCT01849250,,2013-05-06,2019-07-08,,2021-12-03,2013-05-06,2013-05-08,ESTIMATED,2021-12-03,2021-12-28,ACTUAL,,,,2021-12-03,2021-12-28,ACTUAL,2013-05,ACTUAL,2013-05-31,2021-12,2021-12-31,2020-04-22,ACTUAL,2020-04-22,2016-01-11,ACTUAL,2016-01-11,,INTERVENTIONAL,,,Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors,"A Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Patients With a History of Breast Cancer, Premalignant Lesions, or Benign Breast Disease",COMPLETED,,PHASE2,65.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 07:37:45.443067,2024-10-16 07:37:45.443067,NIH,,,,,,,2020,1.0
NCT03541369,,2018-05-18,2024-01-02,,2024-07-15,2018-05-18,2018-05-30,ACTUAL,2024-07-15,2024-10-10,ACTUAL,,,,2024-07-15,2024-10-10,ACTUAL,2018-09-14,ACTUAL,2018-09-14,2024-07,2024-07-31,2023-02-21,ACTUAL,2023-02-21,2023-02-21,ACTUAL,2023-02-21,,INTERVENTIONAL,20170528,,"Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia","A Phase 1 First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia.",TERMINATED,,PHASE1,64.0,ACTUAL,Amgen,"Due to the early termination of the study, the dose expansion cohort was not opened, and the secondary endpoint for duration of response which was pre-specified for the dose expansion cohort was not collected.",2.0,,"Premature discontinuation of study, a strategic decision.",f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-15 20:03:57.559875,2024-10-15 20:03:57.559875,INDUSTRY,,,,,,,2023,0.0
NCT03891420,,2019-03-15,,,2021-05-25,2019-03-25,2019-03-27,ACTUAL,,,,,,,2021-05-25,2021-05-27,ACTUAL,2020-04-09,ACTUAL,2020-04-09,2021-05,2021-05-31,2021-04-30,ACTUAL,2021-04-30,2021-01-31,ACTUAL,2021-01-31,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effects of Galidesivir in Yellow Fever or COVID-19","A Phase 1b Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Pharmacokinetics, and Anti-viral Effects of Galidesivir Administered Via Intravenous Infusion to Subjects With Yellow Fever or COVID-19",TERMINATED,,PHASE1,24.0,ACTUAL,BioCryst Pharmaceuticals,,2.0,,Sponsor decision to no longer pursue indications studied in this trial,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,INDUSTRY,,,,,,,2021,0.0
NCT04684381,,2020-12-18,,,2022-07-29,2020-12-22,2020-12-24,ACTUAL,,,,,,,2022-07-29,2022-08-02,ACTUAL,2021-01-04,ACTUAL,2021-01-04,2022-07,2022-07-31,2021-06-30,ACTUAL,2021-06-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,,,Pharmacokinetics and Safety of Endari (L-glutamine) in Sickle Cell Disease Patients,"A Phase 4, Open-Label, Single-Center Study to Assess Pharmacokinetic Characteristics and Safety of Endari in Patients With Sickle Cell Disease",COMPLETED,,PHASE4,13.0,ACTUAL,"Emmaus Medical, Inc.",,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,INDUSTRY,,,,,,,2021,1.0
NCT03161483,,2017-05-18,2021-01-19,,2023-06-13,2017-05-18,2017-05-19,ACTUAL,2021-02-11,2021-02-18,ACTUAL,,,,2023-06-13,2023-06-15,ACTUAL,2017-08-31,ACTUAL,2017-08-31,2023-06,2023-06-30,2021-08-03,ACTUAL,2021-08-03,2021-08-03,ACTUAL,2021-08-03,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus,"A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS",COMPLETED,,PHASE2,289.0,ACTUAL,Celgene,,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,INDUSTRY,,,,,,,2021,1.0
NCT03329690,,2017-10-30,2020-11-03,,2022-03-17,2017-10-30,2017-11-06,ACTUAL,2020-11-03,2020-11-27,ACTUAL,,,,2022-03-17,2022-03-18,ACTUAL,2017-11-02,ACTUAL,2017-11-02,2022-03,2022-03-31,2020-12-11,ACTUAL,2020-12-11,2019-11-08,ACTUAL,2019-11-08,,INTERVENTIONAL,,Baseline and demographic characteristics were assessed in the Full Analysis Set.,DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01],"A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma",COMPLETED,,PHASE2,233.0,ACTUAL,Daiichi Sankyo,,4.0,,,f,,,,,t,f,,,t,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,INDUSTRY,,,,,,,2020,1.0
NCT04356690,,2020-04-17,2023-04-24,,2023-05-22,2020-04-20,2020-04-22,ACTUAL,2023-05-22,2023-06-15,ACTUAL,,,,2023-05-22,2023-06-15,ACTUAL,2020-05-08,ACTUAL,2020-05-08,2023-05,2023-05-31,2022-07-01,ACTUAL,2022-07-01,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,,,Etoposide in Patients With COVID-19 Infection,"A Phase II Single-Center, Randomized, Open-Label, Safety and Efficacy Study of Etoposide in Patients With COVID-19 Infection",TERMINATED,,PHASE2,8.0,ACTUAL,Boston Medical Center,"The study was halted prematurely due to slow accrual, change in COVID prevalence, and the availability of an effective vaccine.",2.0,,"Slow accrual, change in COVID prevalence, availability of effective vaccine",f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,OTHER,,,,,,,2022,0.0
NCT03878914,,2019-03-12,,,2022-04-25,2019-03-14,2019-03-18,ACTUAL,,,,,,,2022-04-25,2022-05-02,ACTUAL,2019-08-06,ACTUAL,2019-08-06,2022-04,2022-04-30,2021-10-31,ACTUAL,2021-10-31,2021-10-31,ACTUAL,2021-10-31,,INTERVENTIONAL,,,Steroid Sensitive Nephrotic Syndrome in Children,A Multinational Prospective Study on the Duration of Steroid Therapy in Steroid Sensitive Nephrotic Syndrome,TERMINATED,,PHASE4,34.0,ACTUAL,Wayne State University,,2.0,,The study was terminated at all but one site because of the pandemic,f,,,,f,t,f,,,f,,,,,,NO,"Depending on available resources, we may share data without any patient identifier with the study site investigators as well as others who might be interested.",2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,OTHER,,,,,,,2021,0.0
NCT03633227,,2018-04-08,2022-07-07,,2022-08-12,2018-08-13,2018-08-16,ACTUAL,2022-08-12,2022-09-06,ACTUAL,,,,2022-08-12,2022-09-06,ACTUAL,2018-06-22,ACTUAL,2018-06-22,2022-08,2022-08-31,2021-07-09,ACTUAL,2021-07-09,2021-07-09,ACTUAL,2021-07-09,,INTERVENTIONAL,,The Intent-to-treat (ITT) population included all randomized participants who received any amount of investigational product (OCA or placebo).,Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment,"A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment",TERMINATED,,PHASE4,22.0,ACTUAL,Intercept Pharmaceuticals,,2.0,,"Due to Ocaliva (obeticholic acid) US labeling update, the sponsor decided to terminate the study.",f,,,,t,t,f,,,,,,,,,,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,INDUSTRY,,,,,,,2021,0.0
NCT03941834,,2019-04-29,2024-05-07,,2024-06-07,2019-05-06,2019-05-08,ACTUAL,2024-06-07,2024-06-10,ACTUAL,,,,2024-06-07,2024-06-10,ACTUAL,2019-06-25,ACTUAL,2019-06-25,2024-05,2024-05-31,2023-05-11,ACTUAL,2023-05-11,2023-05-11,ACTUAL,2023-05-11,,INTERVENTIONAL,,Participants who received at least 1 dose of double-blind study drug in DBT phase and OLE phase. Participants in DBT and OLE phases are not exclusive. Eligible participants from DBT phase entered OLE phase after completing treatment in DBT phase.,Trial for Treatment Refractory Trigeminal Neuralgia,"BHV3000-202: Phase 2: A Double-Blind, Placebo Controlled, Crossover Trial of BHV-3000 (Rimegepant) for Treatment Refractory Trigeminal Neuralgia",TERMINATED,,PHASE2,65.0,ACTUAL,Pfizer,,2.0,,Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.,,,,,,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,INDUSTRY,,,,,,,2023,0.0
NCT04649203,,2020-11-24,,,2023-01-25,2020-11-24,2020-12-02,ACTUAL,,,,,,,2023-01-25,2023-01-27,ACTUAL,2020-11-25,ACTUAL,2020-11-25,2023-01,2023-01-31,2021-06-06,ACTUAL,2021-06-06,2021-03-29,ACTUAL,2021-03-29,,INTERVENTIONAL,CYLINDER,,Cytoflavin in the Treatment of Patients With Diabetic Polyneuropathy,"Multicenter, Double-blind, Placebo-controlled Randomized Clinical Trial of Efficacy and Safety of the Drug Cytoflavin®, Administered Intravenously Followed by Oral Intake, in Patients With Diabetic Polyneuropathy",COMPLETED,,PHASE3,216.0,ACTUAL,POLYSAN Scientific & Technological Pharmaceutical Company,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,INDUSTRY,,,,,,,2021,1.0
NCT03235544,,2017-07-27,2022-01-14,,2024-05-31,2017-07-27,2017-08-01,ACTUAL,2022-01-14,2022-02-10,ACTUAL,,,,2024-05-31,2024-06-24,ACTUAL,2017-11-20,ACTUAL,2017-11-20,2024-05,2024-05-31,2024-04-30,ACTUAL,2024-04-30,2021-03-03,ACTUAL,2021-03-03,,INTERVENTIONAL,(CITADEL-205),Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of parsaclisib.,A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor,"A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)",COMPLETED,,PHASE2,162.0,ACTUAL,Incyte Corporation,,4.0,,,f,,,,t,t,f,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.",https://www.incyte.com/our-company/compliance-and-transparency,YES,"Individual participant data (IPD) will be made available to interested researchers after the end of study, a thorough analysis, and the publication of the data in the clinical study report (CSR). As required, results of the data will be posted to ClinicalTrials.gov. Upon request, individual investigators may obtain IPD from the sponsor. The format for data delivery will be determined between sponsor and investigator.",2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,INDUSTRY,,,,,,,2024,1.0
NCT03075462,,2017-03-06,,,2022-06-30,2017-03-06,2017-03-09,ACTUAL,,,,,,,2022-06-30,2022-07-01,ACTUAL,2017-03-09,ACTUAL,2017-03-09,2022-06,2022-06-30,2021-12-13,ACTUAL,2021-12-13,2021-08-22,ACTUAL,2021-08-22,,INTERVENTIONAL,,,A Study of Fluzoparib Given in Combination With Apatinib in Ovarian or Breast Cancer Patients,"An Open, Non-randomised, Multi-centre Phase I Study to Assess the Safety and Efficacy of Fluzoparib Given in Combination With Apatinib in Patients With Recurrent Ovarian Cancer or Triple Negative Breast Cancer",COMPLETED,,PHASE1,98.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,1.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,INDUSTRY,,,,,,,2021,1.0
NCT04059445,,2019-07-09,,,2023-11-27,2019-08-15,2019-08-16,ACTUAL,,,,,,,2023-11-27,2023-11-30,ACTUAL,2019-10-15,ACTUAL,2019-10-15,2023-11,2023-11-30,2023-11-27,ACTUAL,2023-11-27,2023-11-27,ACTUAL,2023-11-27,,INTERVENTIONAL,FURC-II-REGEN,,Mandibular Furcation II Regeneration,"Biphasic Calcium Phosphate and a Collagen Membrane or Biphasic Calcium Phosphate and Enamel Matrix Proteins, in the Regenerative Treatment of Furcation Grade II Defects",TERMINATED,,PHASE4,5.0,ACTUAL,University of Oslo,,2.0,,Recruitment problem,f,,,,,f,f,,,f,,,,,,,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,OTHER,,,,,,,2023,0.0
NCT04729088,,2021-01-25,,,2021-01-28,2021-01-27,2021-01-28,ACTUAL,,,,,,,2021-01-28,2021-02-01,ACTUAL,2020-12-20,ACTUAL,2020-12-20,2021-01,2021-01-31,2020-12-20,ACTUAL,2020-12-20,2020-12-20,ACTUAL,2020-12-20,,INTERVENTIONAL,,,Pharmacokinetics Trial of Isosorbide Mononitrate 0.5% Gel for Intra Anal Application in Healthy Subjects,"Phase I Clinical Trial to Evaluate the Pharmacokinetic Profile of a Formulation With Isosorbide Mononitrate 0.5% Gel - Manufactured by Sanus Pharmaceutical Ltda, to Intra Anal Application in Healthy Males and Females' Subjects",WITHDRAWN,,PHASE1,0.0,ACTUAL,Biolab Sanus Farmaceutica,,1.0,,The sponsor will no longer develop the experimental drug.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,INDUSTRY,,,,,,,2020,0.0
NCT04746612,,2021-01-19,,,2023-03-28,2021-02-08,2021-02-10,ACTUAL,,,,,,,2023-03-28,2023-03-30,ACTUAL,2021-04-08,ACTUAL,2021-04-08,2022-12,2022-12-31,2023-03-24,ACTUAL,2023-03-24,2023-03-24,ACTUAL,2023-03-24,,INTERVENTIONAL,,,"First in Human Study to Evaluate the Safety, Tolerability of HH30134 in Advanced Solid Tumors","A Phase I, Multi-centre, Open-Label, First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH30134 in Patients With Advanced Solid Tumours",TERMINATED,,PHASE1,22.0,ACTUAL,"Haihe Biopharma Co., Ltd.",,1.0,,Sponsor business decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,INDUSTRY,,,,,,,2023,0.0
NCT04387617,,2020-05-11,2022-11-16,,2022-12-21,2020-05-11,2020-05-14,ACTUAL,2022-12-21,2023-01-18,ACTUAL,,,,2022-12-21,2023-01-18,ACTUAL,2021-02-15,ACTUAL,2021-02-15,2022-12,2022-12-31,2022-01-31,ACTUAL,2022-01-31,2022-01-31,ACTUAL,2022-01-31,,INTERVENTIONAL,,,A Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney Stones,Effect of Cannabidiol Oil on Postoperative Pain After Ureteroscopy for Urinary Calculi,COMPLETED,,PHASE2/PHASE3,90.0,ACTUAL,Mayo Clinic,,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,OTHER,,,,,,,2022,1.0
NCT04021277,,2019-07-03,,,2024-10-08,2019-07-15,2019-07-16,ACTUAL,,,,,,,2024-10-08,2024-10-10,ACTUAL,2019-09-17,ACTUAL,2019-09-17,2024-10,2024-10-31,2024-09-24,ACTUAL,2024-09-24,2024-08-27,ACTUAL,2024-08-27,,INTERVENTIONAL,ACT,,PS101-mediated ACT With Chemotherapy in Liver Metastases From Cancer of Gastrointestinal Origin,Phase I Trial of the Combination of PS101-Mediated Acoustic Cluster Therapy (ACT) With Chemotherapy for Treatment of Liver Metastasis In Patients With Solid Tumours With an Expansion Cohort in Metastatic Colorectal And Pancreatic Cancer,TERMINATED,,PHASE1,11.0,ACTUAL,EXACT Therapeutics AS,,2.0,,Business reason,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 20:03:57.559875,2024-10-15 20:03:57.559875,INDUSTRY,,,,,,,2024,0.0
NCT03203642,,2017-06-26,2023-01-10,,2023-01-10,2017-06-28,2017-06-29,ACTUAL,2023-01-10,2023-02-06,ACTUAL,,,,2023-01-10,2023-02-06,ACTUAL,2017-10-12,ACTUAL,2017-10-12,2023-01,2023-01-31,2022-01-25,ACTUAL,2022-01-25,2022-01-25,ACTUAL,2022-01-25,,INTERVENTIONAL,,Analysis was performed on modified Intent-To-Treat (mITT) population which included all randomized participants who receive at least 1 dose of study drug.,Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD,A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects With Autosomal Dominant Polycystic Kidney Disease,COMPLETED,,PHASE2,80.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,INDUSTRY,,,,,,,2022,1.0
NCT03331146,,2017-10-20,,,2018-09-25,2017-10-31,2017-11-06,ACTUAL,,,,,,,2018-09-25,2018-09-27,ACTUAL,2018-10-01,ESTIMATED,2018-10-01,2018-09,2018-09-30,2020-12-01,ESTIMATED,2020-12-01,2019-06-01,ESTIMATED,2019-06-01,,INTERVENTIONAL,,,Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass,"Randomized, Controlled, Double-blinded Pilot Study: Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass",WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Alabama at Birmingham,,2.0,,Principal Investigator made aware of similar studies that have already been published.,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,OTHER,,,,,,,2020,0.0
NCT04330495,,2020-03-31,,,2021-09-08,2020-03-31,2020-04-01,ACTUAL,,,,,,,2021-09-08,2021-09-16,ACTUAL,2020-04-06,ESTIMATED,2020-04-06,2021-09,2021-09-30,2021-08-27,ACTUAL,2021-08-27,2020-11-06,ESTIMATED,2020-11-06,,INTERVENTIONAL,,,"Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under Biological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2 Infection","Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under Biological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2 Infection",WITHDRAWN,,PHASE4,0.0,ACTUAL,Instituto de Investigación Marqués de Valdecilla,,2.0,,* Care pressures on the investigator team during the COVID-19 pandemic.~* Subsequent appearance of scientific evidence on the lack of efficacy of hydroxychloroquine in the treatment or prophylaxis of COVID-19 infection.,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,OTHER,,,,,,,2021,0.0
NCT01889199,,2013-06-20,,,2024-05-09,2013-06-26,2013-06-28,ESTIMATED,,,,,,,2024-05-09,2024-05-10,ACTUAL,2013-04,,2013-04-30,2024-05,2024-05-31,2023-07-06,ACTUAL,2023-07-06,2023-07-06,ACTUAL,2023-07-06,,INTERVENTIONAL,,,Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women,Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women,COMPLETED,,PHASE2,45.0,ACTUAL,"University of California, Los Angeles",,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,OTHER,,,,,,,2023,1.0
NCT05008913,,2021-08-10,,,2022-09-02,2021-08-10,2021-08-17,ACTUAL,,,,,,,2022-09-02,2022-09-06,ACTUAL,2021-10-01,ACTUAL,2021-10-01,2022-08,2022-08-31,2021-11-16,ACTUAL,2021-11-16,2021-11-16,ACTUAL,2021-11-16,,INTERVENTIONAL,ADME,,"Human Absorption, Distribution, Metabolism, and Excretion Study of [14C]Adavosertib","A Phase I, Open-Label, Non-Randomised Study of the Absorption, Distribution, Metabolism, and Excretion of Adavosertib After a Single Oral Dose of [14C]Adavosertib to Patients With Advanced Solid Tumours",TERMINATED,,PHASE1,2.0,ACTUAL,AstraZeneca,,1.0,,Study terminated because the clinical development programme for Adavosertib has been discontinued,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,INDUSTRY,,,,,,,2021,0.0
NCT04556734,,2020-09-15,2024-05-30,,2024-05-30,2020-09-15,2020-09-21,ACTUAL,2024-05-30,2024-06-26,ACTUAL,,,,2024-05-30,2024-06-26,ACTUAL,2020-07-29,ACTUAL,2020-07-29,2024-05,2024-05-31,2023-06-07,ACTUAL,2023-06-07,2023-06-07,ACTUAL,2023-06-07,,INTERVENTIONAL,,"DB Treatment Period randomized set included all randomized participants, irrespective of whether they received any study drug. OLE Safety set (SAF) included all participants who received at least 1 dose of study drug. Participants in DB treatment period and OLE period are not exclusive. Eligible participants from DB treatment period entered OLE period after completing treatment in DB treatment period.",Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study, With a 28-Week Open-Label Extension, to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Alopecia Areata",COMPLETED,,PHASE2,80.0,ACTUAL,Pfizer,,3.0,,,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,INDUSTRY,,,,,,,2023,1.0
NCT05135624,,2021-11-09,,,2024-05-21,2021-11-23,2021-11-26,ACTUAL,,,,,,,2024-05-21,2024-05-23,ACTUAL,2021-12-01,ACTUAL,2021-12-01,2024-05,2024-05-31,2023-06-30,ACTUAL,2023-06-30,2023-06-30,ACTUAL,2023-06-30,,INTERVENTIONAL,,,SP16 as a Therapeutic for COVID-19 Induced ARDS,SP16 as a Therapeutic for SARS-CoV-2 Induced ARDS,TERMINATED,,PHASE1,2.0,ACTUAL,"Serpin Pharma, LLC",,3.0,,Trial was terminated due to lack of patients.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,OTHER,,,,,,,2023,0.0
NCT05233696,,2022-01-04,,,2022-12-02,2022-01-31,2022-02-10,ACTUAL,,,,,,,2022-12-02,2022-12-06,ACTUAL,2022-01-04,ACTUAL,2022-01-04,2022-12,2022-12-31,2022-12-01,ACTUAL,2022-12-01,2022-12-01,ACTUAL,2022-12-01,,INTERVENTIONAL,,,Radiotherapy in Combo With Chemo and Immunotherapy in Patients With PD-L1 Positive Metastatic TNBC,Phase II Study of Radiotherapy in Combination With Chemotherapy and Immunotherapy in Patients With PD-L1-Positive Metastatic Triple-Negative Breast Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of Colorado, Denver",,1.0,,Low Accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,OTHER,,,,,,,2022,0.0
NCT04219358,,2019-10-04,,,2022-11-17,2020-01-03,2020-01-07,ACTUAL,,,,,,,2022-11-17,2022-11-22,ACTUAL,2019-03-23,ACTUAL,2019-03-23,2022-11,2022-11-30,2021-08-24,ACTUAL,2021-08-24,2020-06-24,ACTUAL,2020-06-24,,INTERVENTIONAL,,,Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis,"Evaluation of Topical Application of 5% Imiquimod, 0.05% Imiquimod and 0.05% Nanoencapsulated Imiquimod Gel in the Treatment of Actinic Cheilitis: a Randomized Controlled Trial",TERMINATED,,PHASE1,49.0,ACTUAL,Hospital de Clinicas de Porto Alegre,,4.0,,Study terminated because of COVID19 pandemics.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,OTHER,,,,,,,2021,0.0
NCT02659527,,2016-01-15,,,2023-06-12,2016-01-19,2016-01-20,ESTIMATED,,,,,,,2023-06-12,2023-06-15,ACTUAL,2016-01,ACTUAL,2016-01-31,2023-06,2023-06-30,2022-08,ACTUAL,2022-08-31,2022-05,ACTUAL,2022-05-31,,INTERVENTIONAL,,,PET/MRI in Patients With Suspected Prostate Cancer,"Randomized Assessment of Patients With Clinically Suspected Prostate Cancer After Multiparametric Metabolic Hybrid Imaging to Evaluate Its Potential Clinical Domain: A Prospective, Randomized, Multi-arm, Multi-treatment Clinical Trial",COMPLETED,,PHASE3,220.0,ACTUAL,Medical University of Vienna,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,OTHER,,,,,,,2022,1.0
NCT05120622,,2021-09-20,,,2023-10-27,2021-11-03,2021-11-15,ACTUAL,,,,,,,2023-10-27,2023-10-31,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2023-10,2023-10-31,2022-05-01,ESTIMATED,2022-05-01,2022-05-01,ESTIMATED,2022-05-01,,INTERVENTIONAL,Rideau,,Trial of Local Cystoscopic Injection of Tremelimumab Plus Systemic Durvalumab for High Risk Non-Muscle Invasive Bladder Cancer,Phase I/II Trial of Local Cystoscopic Injection of Tremelimumab Plus Systemic Durvalumab (MEDI4736) for High Risk Non-Muscle Invasive Bladder Cancer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of British Columbia,,1.0,,Withdrawal of funding,f,,,,,t,f,,,t,,,,,,NO,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,OTHER,,,,,,,2022,0.0
NCT01434472,,2011-07-26,2021-04-30,,2021-07-16,2011-09-14,2011-09-15,ESTIMATED,2021-04-30,2021-05-25,ACTUAL,,,,2021-07-16,2021-07-20,ACTUAL,2011-11-16,ACTUAL,2011-11-16,2021-07,2021-07-31,2020-05-06,ACTUAL,2020-05-06,2020-05-06,ACTUAL,2020-05-06,,INTERVENTIONAL,,,High-Dose Y-90-Ibritumomab Tiuxetan Added to Reduced-Intensity Allogeneic Stem Cell Transplant Regimen for Relapsed or Refractory Aggressive B-Cell Lymphoma,A Phase II Trial of High-Dose 90Y-Ibritumomab Tiuxetan (Anti-CD20) Followed by Fludarabine and Low-Dose Total Body Irradiation and HLA-Matched Allogeneic Hematopoietic Transplantation for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma,TERMINATED,,PHASE2,20.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,Terminated due to insufficient funding,f,,,,f,,,,,,,,,,,,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,OTHER,,,,,,,2020,0.0
NCT05260008,,2022-02-18,,,2024-06-24,2022-02-18,2022-03-02,ACTUAL,,,,,,,2024-06-24,2024-06-26,ACTUAL,2022-06-07,ACTUAL,2022-06-07,2024-06,2024-06-30,2024-01-15,ACTUAL,2024-01-15,2024-01-15,ACTUAL,2024-01-15,,INTERVENTIONAL,SPARK,,Study Assessing Pain Relief After Replacement of the Knee,"A Phase 2B, Randomized, Double Blind, Active Comparator, Multicenter, Safety, and Efficacy Trial of ATX-101 in Subjects Undergoing Total Knee Arthroplasty",TERMINATED,,PHASE2,112.0,ACTUAL,"Allay Therapeutics, Inc.",,3.0,,"Based on positive data from the dose-ranging portion of the study, Sponsor decided as of May 28, 2024 not to move forward with the previously designed global ATX101-TKA-003 study.",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 17:07:51.065321,2024-10-16 17:07:51.065321,INDUSTRY,,,,,,,2024,0.0
NCT03777579,,2018-12-12,,,2019-08-06,2018-12-13,2018-12-17,ACTUAL,,,,,,,2019-08-06,2019-08-08,ACTUAL,2018-12-21,ACTUAL,2018-12-21,2018-12,2018-12-31,2020-07-30,ESTIMATED,2020-07-30,2019-12-30,ESTIMATED,2019-12-30,,INTERVENTIONAL,,,A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC,"A Phase III, Multicenter, Randomized, Placebo-Controlled Study of JS001 (Anti-PD-1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel as First-line Therapy for Patients With Primarily Diagnose or Recurrent and Metastatic Triple-Negative Breast Cancer",SUSPENDED,,PHASE3,375.0,ESTIMATED,"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.",,2.0,,trial handovered to another sponser.,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,INDUSTRY,,,,,,,2020,0.0
NCT03833427,,2019-02-06,,,2022-07-08,2019-02-06,2019-02-07,ACTUAL,,,,,,,2022-07-08,2022-07-11,ACTUAL,2019-03-18,ACTUAL,2019-03-18,2022-07,2022-07-31,2022-06-28,ACTUAL,2022-06-28,2022-06-28,ACTUAL,2022-06-28,,INTERVENTIONAL,,,Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (MK-5618-001),A Phase 1b Multi-center Clinical Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors.,COMPLETED,,PHASE1,32.0,ACTUAL,Merck Sharp & Dohme LLC,,7.0,,,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,INDUSTRY,,,,,,,2022,0.0
NCT03245008,,2017-08-07,2023-03-08,,2023-04-23,2017-08-07,2017-08-10,ACTUAL,2023-04-23,2023-05-17,ACTUAL,,,,2023-04-23,2023-05-17,ACTUAL,2017-09-08,ACTUAL,2017-09-08,2023-04,2023-04-30,2021-03-09,ACTUAL,2021-03-09,2019-12-14,ACTUAL,2019-12-14,,INTERVENTIONAL,,The pooled placebo group (N=204) and the pooled MT-5547 1 mg q4w group (N=203) showed the total number of participants randomized to each group before and after the protocol amendment.~The number of participants who were randomized to the placebo group (N=165) and the MT-5547 1 mg q4w group (N=165) after the protocol amendment were not shown in the table below because they are included in the respective pooled groups. A total of 626 participants were enrolled into this study.,Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain,"A Phase 2/3 (Placebo-Controlled, Double-Blind, Comparative) Study on MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain",COMPLETED,,PHASE2/PHASE3,626.0,ACTUAL,Mitsubishi Tanabe Pharma Corporation,,3.0,,,f,,,,,t,f,,,t,,,,,,,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,INDUSTRY,,,,,,,2021,1.0
NCT03895996,,2019-03-15,,,2024-07-09,2019-03-28,2019-03-29,ACTUAL,,,,,,,2024-07-09,2024-07-10,ACTUAL,2019-06-20,ACTUAL,2019-06-20,2024-07,2024-07-31,2023-12-19,ACTUAL,2023-12-19,2022-05-17,ACTUAL,2022-05-17,,INTERVENTIONAL,,,"Safety, Tolerability and Potential Efficacy of AVT001 in Patients With Type 1 Diabetes","A Phase 1 / 2 Double-Blind, Randomized, Placebo Controlled Study of Safety, Tolerability and Potential Efficacy of AVOTRES Cell-Based Therapy (AVT001) in Patients With Type 1 Diabetes",COMPLETED,,PHASE1/PHASE2,25.0,ACTUAL,Avotres Inc.,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,INDUSTRY,,,,,,,2023,1.0
NCT04045613,,2019-07-26,2023-08-14,,2023-09-21,2019-08-02,2019-08-05,ACTUAL,2023-09-21,2023-10-13,ACTUAL,,,,2023-09-21,2023-10-13,ACTUAL,2019-08-02,ACTUAL,2019-08-02,2023-09,2023-09-30,2022-10-04,ACTUAL,2022-10-04,2022-10-04,ACTUAL,2022-10-04,,INTERVENTIONAL,FIDES-02,,Derazantinib and Atezolizumab in Patients With Urothelial Cancer,An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations,COMPLETED,,PHASE1/PHASE2,95.0,ACTUAL,Basilea Pharmaceutica,,7.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,INDUSTRY,,,,,,,2022,0.0
NCT03650452,,2018-08-27,2021-01-19,,2021-02-09,2018-08-27,2018-08-28,ACTUAL,2021-02-09,2021-02-18,ACTUAL,,,,2021-02-09,2021-02-18,ACTUAL,2018-08-08,ACTUAL,2018-08-08,2021-01,2021-01-31,2020-07-20,ACTUAL,2020-07-20,2020-06-09,ACTUAL,2020-06-09,,INTERVENTIONAL,ELEKTRA,Randomized Analysis Set included all participants who were randomized into the study.,"A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies","A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic Encephalopathies",COMPLETED,,PHASE2,141.0,ACTUAL,Takeda,,2.0,,,,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,INDUSTRY,,,,,,,2020,1.0
NCT03226080,,2017-05-01,,,2019-08-17,2017-07-19,2017-07-21,ACTUAL,,,,,,,2019-08-17,2019-08-20,ACTUAL,2017-07-19,ACTUAL,2017-07-19,2019-08,2019-08-31,2020-08,ESTIMATED,2020-08-31,2019-08,ESTIMATED,2019-08-31,,INTERVENTIONAL,,,GA/Spinal vs. GA/Spinal/NMB for Operative Repair of Hip Fracture,Combined General and Spinal Anesthesia vs. Combined General and Spinal Anesthesia With Neuromuscular Blockade for Operative Repair of Hip Fractures,WITHDRAWN,,PHASE4,0.0,ACTUAL,Loyola University,,2.0,,Study terminated with IRB on 20Feb2019 due to lack of enrollment.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,OTHER,,,,,,,2020,0.0
NCT02554253,,2015-09-16,2021-09-30,,2022-01-24,2015-09-17,2015-09-18,ESTIMATED,2022-01-24,2022-02-15,ACTUAL,,,,2022-01-24,2022-02-15,ACTUAL,2015-09,,2015-09-30,2022-01,2022-01-31,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,,"52 patients were enrolled. 3 patients did not complete the study. 1 patient was found to be ineligible after enrollment, 1 patient transitioned to a procedure that was in the exclusion criteria, and one patient received both the induction medications. This resulted in 25 patients for analysis in the ketamine group and 24 patients in the Propofol group.","The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction","The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction in Patients 75 Years of Age or Older and Undergoing Cardiac Surgery",COMPLETED,,PHASE2,52.0,ACTUAL,Mayo Clinic,Not powered to detect differences in acute kidney injury. A larger study will be needed.,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,OTHER,,,,,,,2020,1.0
NCT00946712,,2009-07-24,2018-12-06,,2023-05-19,2009-07-24,2009-07-27,ESTIMATED,2019-02-13,2019-03-07,ACTUAL,,,,2023-05-19,2023-05-23,ACTUAL,2009-07-15,,2009-07-15,2023-05,2023-05-31,2022-02-08,ACTUAL,2022-02-08,2017-08-31,ACTUAL,2017-08-31,,INTERVENTIONAL,,Only eligible patients are included in the analysis.,S0819: Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer,"A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab With or Without Concurrent Cetuximab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)",TERMINATED,,PHASE3,1333.0,ACTUAL,SWOG Cancer Research Network,,2.0,,terminated at pre-planned futility analysis,f,,,,t,,,,,,,,,,,,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,NETWORK,,,,,,,2022,0.0
NCT02762266,,2016-04-05,2023-12-12,,2024-03-08,2016-05-02,2016-05-04,ESTIMATED,2024-03-08,2024-03-12,ACTUAL,,,,2024-03-08,2024-03-12,ACTUAL,2016-02-27,ACTUAL,2016-02-27,2024-03,2024-03-31,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,Participants who received treatment,Transarterial Chemoembolization Compared With Stereotactic Body Radiation Therapy or Stereotactic Ablative Radiation Therapy in Treating Patients With Residual or Recurrent Liver Cancer Undergone Initial Transarterial Chemoembolization,International Randomized Study of Transarterial Chemoembolization (TACE) Versus Stereotactic Body Radiotherapy (SBRT) / Stereotactic Ablative Radiotherapy (SABR) for Residual or Recurrent Hepatocellular Carcinoma After Initial TACE,TERMINATED,,PHASE3,13.0,ACTUAL,Stanford University,This study did not enroll the planned number of participants and did not meet the protocol-prespecified threshold for statistical significance.,2.0,,Business decision - funding,f,,,,t,,,,,,,,,,,NO,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,OTHER,,,,,,,2022,0.0
NCT05447364,,2022-06-26,,,2024-04-14,2022-07-01,2022-07-07,ACTUAL,,,,,,,2024-04-14,2024-04-16,ACTUAL,2021-07-01,ACTUAL,2021-07-01,2024-04,2024-04-30,2024-03-01,ACTUAL,2024-03-01,2023-09-01,ACTUAL,2023-09-01,,INTERVENTIONAL,,,Efficacy of Different Doses of Pregabalin as a Multimodal Analgesic Agent in Postoperative Pain Control After Total Knee Arthroplasty,Efficacy of Different Doses of Pregabalin as a Multimodal Analgesic Agent in Postoperative Pain Control After Total Knee Arthroplasty - A Randomized Controlled Trial,COMPLETED,,PHASE4,82.0,ACTUAL,Thammasat University,,2.0,,,f,,,,t,f,f,,,f,,,Beginning 3 months and ending 5 years following article publication.,"* Researchers who provide a methodologically sound proposal.~* To achieve aims in the approved proposal.~* Proposals should be directed to thesekku@gmail.com.~* To gain access, data requestors will need to sign a data access agreement.",,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)",2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,OTHER,,,,,,,2024,1.0
NCT02344407,,2015-01-22,2017-05-25,,2021-03-17,2015-01-22,2015-01-26,ESTIMATED,2017-05-25,2017-08-01,ACTUAL,,,,2021-03-17,2021-04-08,ACTUAL,2015-01-20,,2015-01-20,2021-03,2021-03-31,2020-11-01,ACTUAL,2020-11-01,2016-06-01,ACTUAL,2016-06-01,,INTERVENTIONAL,,,Partnership for Research on Ebola Vaccines in Liberia (PREVAIL),Partnership for Research on Ebola Vaccines in Liberia (PREVAIL),COMPLETED,,PHASE2,1500.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,,,,,,t,,,,,,,,,,,,,2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,NIH,,,,,,,2020,1.0
NCT03504774,,2018-04-03,2024-01-05,,2024-03-24,2018-04-19,2018-04-20,ACTUAL,2024-02-09,2024-03-06,ACTUAL,,,,2024-03-24,2024-03-26,ACTUAL,2019-07-09,ACTUAL,2019-07-09,2024-03,2024-03-31,2023-03-03,ACTUAL,2023-03-03,2023-01-13,ACTUAL,2023-01-13,,INTERVENTIONAL,MOTIF,,Food Allergen OIT for Shrimp and Cashew,T Cell Reagent Research for Monitoring T Cells in Food Allergy (MOTIF) Phase 2 Study Using Food Allergen Oral Immunotherapy for Shrimp or Cashew Allergies,TERMINATED,,PHASE2,58.0,ACTUAL,Stanford University,"Due to the COVID-19 pandemic, this study did not enroll the planned number of participants and did not meet the protocol-specified threshold for statistical significance.",1.0,,Study discontinued due to slow enrollment during COVID-19 pandemic,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,OTHER,,,,,,,2023,0.0
NCT04220008,,2020-01-03,,,2024-01-11,2020-01-03,2020-01-07,ACTUAL,,,,,,,2024-01-11,2024-01-12,ACTUAL,2021-10-29,ACTUAL,2021-10-29,2024-01,2024-01-31,2021-10-29,ACTUAL,2021-10-29,2021-10-29,ACTUAL,2021-10-29,,INTERVENTIONAL,,,Vorinostat and Combination Chemotherapy Before Donor Stem Cell Transplantation for the Treatment of Relapsed Aggressive B-cell or T-cell Non-Hodgkin Lymphoma,Vorinostat With Gemcitabine/Clofarabine/Busulfan for Allogeneic Transplantation for Aggressive Lymphomas,WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,No Participants Enrolled,f,,,,f,t,f,,,,,,,,,,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,OTHER,,,,,,,2021,0.0
NCT04382053,,2020-05-08,2021-11-15,,2022-06-27,2020-05-08,2020-05-11,ACTUAL,2021-11-25,2021-11-30,ACTUAL,,,,2022-06-27,2022-07-26,ACTUAL,2020-05-27,ACTUAL,2020-05-27,2022-06,2022-06-30,2020-12-24,ACTUAL,2020-12-24,2020-12-10,ACTUAL,2020-12-10,,INTERVENTIONAL,,,Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia,"Phase 2, Randomized, Controlled, Open Label Multi-center Study to Assess Efficacy and Safety of DFV890 for the Treatment of SARS-CoV-2 Infected Patients With COVID-19 Pneumonia and Impaired Respiratory Function",COMPLETED,,PHASE2,143.0,ACTUAL,Novartis,,2.0,,,f,,,,t,t,f,,,t,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-15 20:06:37.745812,2024-10-15 20:06:37.745812,INDUSTRY,,,,,,,2020,1.0
NCT04623996,,2020-10-20,2023-02-06,,2023-11-07,2020-11-09,2020-11-10,ACTUAL,2023-03-06,2023-03-30,ACTUAL,,,,2023-11-07,2023-11-09,ACTUAL,2020-12-28,ACTUAL,2020-12-28,2023-11,2023-11-30,2021-04-27,ACTUAL,2021-04-27,2021-04-27,ACTUAL,2021-04-27,,INTERVENTIONAL,,The company decided to terminate further development of the TP-0184 program. No patients were enrolled into phase 2.,A Study of TP-0184 to Treat Anemia in Adults With IPSS-R Low or Intermediate Risk MDS,"A Phase 1/2, Open-Label Clinical Study To Evaluate Safety And Efficacy Of TP-0184 To Treat Anemia When Administered To Adult Patients With IPSS-R Low Or Intermediate Risk Myelodysplastic Syndromes",TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,"Sumitomo Pharma America, Inc.",,1.0,,"Due to limitations imposed by the COVID pandemic and the competitive landscape for myelodysplastic syndrome, this study was unable to enroll a sufficient patient population.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 20:06:37.745812,2024-10-15 20:06:37.745812,INDUSTRY,,,,,,,2021,0.0
NCT06461949,,2024-06-08,,,2024-07-24,2024-06-14,2024-06-17,ACTUAL,,,,,,,2024-07-24,2024-07-25,ACTUAL,2024-07-17,ACTUAL,2024-07-17,2024-07,2024-07-31,2024-07-17,ACTUAL,2024-07-17,2024-07-17,ACTUAL,2024-07-17,,INTERVENTIONAL,,,Study of Dupilumab 300 mg Every Other Week After Endoscopic Sinus Surgery in Patients With Allergic Fungal Rhinosinusitis (AFRS) on a Background Therapy With Intranasal Corticosteroid Spray,"A Randomized, 52-Week Treatment Double-Blind, Placebo-Controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week After Endoscopic Sinus Surgery in Patients With Allergic Fungal Rhinosinusitis (AFRS) on a Background Therapy With Intranasal Corticosteroid Spray",WITHDRAWN,,PHASE3,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,"Closed by sponsor, lack of enrollment.",f,,,,,t,f,,,,,,Post study completion and as determined by NIDCD staff.,,,YES,.Research Data for Statistical Analysis and Scientific Reporting will be shared. All participant data will be de-identified. Participants will be identified only by a unique study identification number.,2024-10-15 20:06:37.745812,2024-10-15 20:06:37.745812,NIH,,,,,,,2024,0.0
NCT03430687,,2018-02-06,,,2020-07-24,2018-02-06,2018-02-13,ACTUAL,,,,,,,2020-07-24,2020-07-28,ACTUAL,2018-06-01,ESTIMATED,2018-06-01,2020-07,2020-07-31,2020-12-31,ESTIMATED,2020-12-31,2019-12-31,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,Talimogene Laherparepvec in Treating Patients With Non-Muscle Invasive Bladder Transitional Cell Carcinoma,A Phase I Study of Intravesical Talimogene Laherparepvec for Non-Muscle Invasive Transitional Cell Carcinoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,"University of California, San Francisco",,1.0,,Investigators prefer to pursue other studies,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,OTHER,,,,,,,2020,0.0
NCT03951961,,2019-05-09,,,2022-01-20,2019-05-14,2019-05-16,ACTUAL,,,,,,,2022-01-20,2022-01-21,ACTUAL,2020-03-20,ACTUAL,2020-03-20,2022-01,2022-01-31,2021-02-28,ACTUAL,2021-02-28,2021-02-28,ACTUAL,2021-02-28,,INTERVENTIONAL,,,Midostaurin in MRD (Minimal Residual Disease) Positive Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation,Midostaurin in MRD (Minimal Residual Disease) Positive Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation,TERMINATED,,PHASE2,1.0,ACTUAL,University of Jena,,1.0,,Insufficient Recruitment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,OTHER,,,,,,,2021,0.0
NCT03149107,,2017-05-08,,,2022-05-03,2017-05-08,2017-05-11,ACTUAL,,,,,,,2022-05-03,2022-05-09,ACTUAL,2016-09-01,ACTUAL,2016-09-01,2022-05,2022-05-31,2021-01,ACTUAL,2021-01-31,2021-01,ACTUAL,2021-01-31,,INTERVENTIONAL,ESPRIT-B1,,Multimodal Prevention of Psychosis - Investigating Efficacy of N-Acetylcysteine and Psychotherapy in CHR-Patients,Multimodal Prevention of First Psychotic Episode - a 2x2-Factorial Randomized Trial Investigating the Efficacy of Acetylcysteine and Integrated Preventive Psychological Intervention in Subjects Clinically at High Risk for Psychosis,TERMINATED,,PHASE3,48.0,ACTUAL,"University Hospital, Bonn",,4.0,,Recruitment not sufficient,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,OTHER,,,,,,,2021,0.0
NCT02772965,,2016-04-27,2023-02-23,,2023-04-10,2016-05-11,2016-05-16,ESTIMATED,2023-04-10,2023-04-12,ACTUAL,,,,2023-04-10,2023-04-12,ACTUAL,2016-10,,2016-10-31,2022-06,2022-06-30,2022-04-07,ACTUAL,2022-04-07,2022-04-07,ACTUAL,2022-04-07,,INTERVENTIONAL,COMBINE,Modified Intent to Treat population presented.,Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy,"A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Pragmatic Clinical Trial To Evaluate The Effectiveness Of Low Dose Oral Methotrexate In Patients With Pediatric Crohn's Disease Initiating Anti-TNF Therapy",COMPLETED,,PHASE3,306.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,OTHER,,,,,,,2022,1.0
NCT03088293,,2017-03-17,,,2022-07-18,2017-03-17,2017-03-23,ACTUAL,,,,,,,2022-07-18,2022-07-20,ACTUAL,2020-06-11,ACTUAL,2020-06-11,2022-07,2022-07-31,2024-07,ESTIMATED,2024-07-31,2023-10,ESTIMATED,2023-10-31,,INTERVENTIONAL,CIRIS,,Cyclophosphamide vs. Infliximab for Refractory Idiopathic Scleritis (CIRIS),A Multicenter Randomized Open-label Trial Comparing the Efficacy and Safety of Infliximab Versus Cyclophosphamide in Subjects With Idiopathic Refractory Scleritis,WITHDRAWN,,PHASE3,0.0,ACTUAL,Hospices Civils de Lyon,,2.0,,recruiting difficulties,f,,,,t,f,f,,,,,,,,,,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,OTHER,,,,,,,2024,0.0
NCT02438995,,2015-05-06,,,2021-10-27,2015-05-07,2015-05-08,ESTIMATED,,,,,,,2021-10-27,2021-11-03,ACTUAL,2015-05,ACTUAL,2015-05-31,2021-10,2021-10-31,2021-06,ACTUAL,2021-06-30,2021-06,ACTUAL,2021-06-30,,INTERVENTIONAL,,,Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck,Phase I Trial of Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck,TERMINATED,,PHASE1,11.0,ACTUAL,Northwell Health,,2.0,,Low enrollment,f,,,,,,,,,,,,,,,,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,OTHER,,,,,,,2021,0.0
NCT01543490,,2012-02-28,2021-02-26,,2021-11-18,2012-03-02,2012-03-05,ESTIMATED,2021-02-26,2021-03-23,ACTUAL,,,,2021-11-18,2021-11-19,ACTUAL,2018-03-30,ACTUAL,2018-03-30,2021-11,2021-11-30,2020-02-04,ACTUAL,2020-02-04,2020-02-04,ACTUAL,2020-02-04,,INTERVENTIONAL,ISV-305,"Demographics were summarized for the Intent-to-treat (ITT) Population, which included all randomized participants regardless of whether post-baseline measures were collected or study treatment was received.",Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects,"A Phase 3, Multicenter, Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical Efficacy and Safety of ISV-305 (0.1% Dexamethasone) Compared to Vehicle in the Treatment of Subjects With Blepharitis",COMPLETED,,PHASE3,558.0,ACTUAL,Sun Pharmaceutical Industries Limited,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,INDUSTRY,,,,,,,2020,1.0
NCT04940871,,2021-05-20,,,2022-11-04,2021-06-17,2021-06-28,ACTUAL,,,,,,,2022-11-04,2022-11-09,ACTUAL,2021-11-25,ACTUAL,2021-11-25,2022-11,2022-11-30,2021-11-29,ACTUAL,2021-11-29,2021-11-29,ACTUAL,2021-11-29,,INTERVENTIONAL,,,Study to Assess the Efficacy and Safety of Favipiravir-HU,"A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Favipiravir-HU Compared to Placebo as add-on Therapy to Standard of Care in Asymptomatic to Mild Severity COVID-19 Patients",TERMINATED,,PHASE2,1.0,ACTUAL,University of Pecs,,2.0,,"Only one patient was enrolled, who who later withdrew the consent. They decided not to contunie the study.",f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,OTHER,,,,,,,2021,0.0
NCT04420455,,2020-01-31,,,2021-12-23,2020-06-03,2020-06-09,ACTUAL,,,,,,,2021-12-23,2022-01-13,ACTUAL,2020-05-12,ACTUAL,2020-05-12,2021-12,2021-12-31,2021-12-21,ACTUAL,2021-12-21,2021-12-21,ACTUAL,2021-12-21,,INTERVENTIONAL,,,The Effects of Enoximone in Acute Exacerbation COPD,The Effects of Enoximone in Acute Exacerbation COPD,TERMINATED,,PHASE4,3.0,ACTUAL,Rijnstate Hospital,,1.0,,A limited number of inclusions due to the Covid-pandemic,f,,,,,f,f,,,f,,,after publication,"upon reasonable request, available by the researchers",,YES,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,OTHER,,,,,,,2021,0.0
NCT03879655,,2018-12-12,2023-11-20,2022-10-07,2023-12-22,2019-03-13,2019-03-19,ACTUAL,2023-12-22,2023-12-26,ACTUAL,,2023-12-26,ACTUAL,2023-12-22,2023-12-26,ACTUAL,2019-12-02,ACTUAL,2019-12-02,2023-12,2023-12-31,2021-10-18,ACTUAL,2021-10-18,2021-10-18,ACTUAL,2021-10-18,,INTERVENTIONAL,,All enrolled participants,Open-label Study of VTS-270 in Participants With Neurologic Manifestations of Niemann-Pick Type C1,A Phase 2B/3 Open-label Trial of VTS-270 (2-hydroxypropyl-β-cyclodextrin) in Subjects With Neurologic Manifestations of Niemann-Pick Type C1 Disease Previously Treated Under Protocol VTS301,TERMINATED,,PHASE2/PHASE3,2.0,ACTUAL,Mandos LLC,Study was terminated by the Sponsor and only 2 participants were enrolled in the study.,1.0,,Terminated by previous Sponsor decision,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,INDUSTRY,,,,,,,2021,0.0
NCT03589105,,2018-07-05,,,2022-01-10,2018-07-05,2018-07-17,ACTUAL,,,,,,,2022-01-10,2022-01-11,ACTUAL,2018-08-06,ACTUAL,2018-08-06,2022-01,2022-01-31,2021-02-15,ACTUAL,2021-02-15,2021-02-15,ACTUAL,2021-02-15,,INTERVENTIONAL,PRO-MSACTIVE,,"A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting","An Open-Label, Single-Arm Phase IV Study To Assess Ocrelizumab Efficacy, Safety, And Impact On Patient Reported Outcomes (PROS) In Patients With Active Relapsing Multiple Sclerosis",COMPLETED,,PHASE4,423.0,ACTUAL,Hoffmann-La Roche,,1.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,INDUSTRY,,,,,,,2021,1.0
NCT04162028,,2019-11-04,,,2021-07-28,2019-11-12,2019-11-13,ACTUAL,,,,,,,2021-07-28,2021-07-30,ACTUAL,2019-01-15,ACTUAL,2019-01-15,2021-07,2021-07-31,2021-07-28,ACTUAL,2021-07-28,2021-07-28,ACTUAL,2021-07-28,,INTERVENTIONAL,,,Pre-hospital Nebulized Ketamine for Pain,Pre-hospital Utilization of Nebulized Sub-dissociative Dose Ketamine for Managing Acute Traumatic Extremity Pain: a Prospective Observational Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,Maimonides Medical Center,,1.0,,Investigators not interested any more in the study,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,OTHER,,,,,,,2021,0.0
NCT05127421,,2021-11-08,2024-07-15,,2024-08-14,2021-11-08,2021-11-19,ACTUAL,2024-08-14,2024-08-15,ACTUAL,,,,2024-08-14,2024-08-15,ACTUAL,2021-11-10,ACTUAL,2021-11-10,2024-08,2024-08-31,2023-09-29,ACTUAL,2023-09-29,2023-08-03,ACTUAL,2023-08-03,,INTERVENTIONAL,,,Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement,"A Phase 2, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement",COMPLETED,,PHASE2,77.0,ACTUAL,Incyte Corporation,,2.0,,,f,,,,f,t,f,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,INDUSTRY,,,,,,,2023,1.0
NCT04606576,,2020-10-22,,,2023-02-07,2020-10-22,2020-10-28,ACTUAL,,,,,,,2023-02-07,2023-02-09,ACTUAL,2020-12-15,ACTUAL,2020-12-15,2023-02,2023-02-28,2023-01-13,ACTUAL,2023-01-13,2023-01-13,ACTUAL,2023-01-13,,INTERVENTIONAL,,,Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus,"A Double-Blinded, Placebo-controlled, Double Dummy, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With T2DM With Inadequate Glycemic Control on 1, 2 or 3 Oral Glucose-lowering Agents.",TERMINATED,,PHASE3,710.0,ACTUAL,"Oramed, Ltd.",,3.0,,"ORA-D-013-1 was terminated based on the primary results analyzed at the end of the treatment, week 26.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,INDUSTRY,,,,,,,2023,0.0
NCT02902133,,2016-04-28,,,2020-04-17,2016-09-09,2016-09-15,ESTIMATED,,,,,,,2020-04-17,2020-04-21,ACTUAL,2016-09-01,ESTIMATED,2016-09-01,2020-04,2020-04-30,2021-09-01,ESTIMATED,2021-09-01,2021-09-01,ESTIMATED,2021-09-01,,INTERVENTIONAL,,,Acetazolamide to Prevent Post Operative CSF Leak,Pilot Study of Acetazolamide to Prevent Post Operative Cerebrospinal Fluid (CSF) Leak in Patients Undergoing Endoscopic Skull Base Surgery,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Miami,,1.0,,No participants were identified per inclusion/exclusion criteria,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,OTHER,,,,,,,2021,0.0
NCT04657016,,2020-12-01,2024-04-16,,2024-05-08,2020-12-01,2020-12-07,ACTUAL,2024-05-08,2024-05-16,ACTUAL,,,,2024-05-08,2024-05-16,ACTUAL,2021-03-29,ACTUAL,2021-03-29,2024-05,2024-05-31,2023-05-12,ACTUAL,2023-05-12,2023-04-20,ACTUAL,2023-04-20,,INTERVENTIONAL,SURMOUNT-3,All randomized participants.,A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program,"Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo After an Intensive Lifestyle Program in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double Blind, Placebo-Controlled Trial (SURMOUNT-3)",COMPLETED,,PHASE3,579.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",Access Criteria:~A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Plan Description:~Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,INDUSTRY,,,,,,,2023,1.0
NCT02357849,,2014-09-30,2023-10-05,,2023-10-27,2015-02-05,2015-02-06,ESTIMATED,2023-10-27,2023-11-15,ACTUAL,,,,2023-10-27,2023-11-15,ACTUAL,2014-07,,2014-07-31,2023-10,2023-10-31,2022-04-04,ACTUAL,2022-04-04,2022-04-04,ACTUAL,2022-04-04,,INTERVENTIONAL,FACT,,Fluoxetine vs Aripiprazole Comparative Trial (FACT),The Role of Antidepressants or Antipsychotics in Preventing Psychosis: Fluoxetine vs Aripiprazole Comparative Trial (FACT),TERMINATED,,PHASE4,9.0,ACTUAL,Northwell Health,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 07:43:53.758434,2024-10-16 07:43:53.758434,OTHER,,,,,,,2022,0.0
NCT04344236,,2020-04-08,,,2021-05-06,2020-04-10,2020-04-14,ACTUAL,,,,,,,2021-05-06,2021-05-10,ACTUAL,2020-04-09,ACTUAL,2020-04-09,2021-05,2021-05-31,2020-05-09,ESTIMATED,2020-05-09,2020-05-01,ESTIMATED,2020-05-01,,INTERVENTIONAL,,,Gargling and Nasal Rinses to Reduce Oro- and Nasopharyngeal Viral Load in Patients With COVID-19,"A Phase II, Randomized, Open-label, Single-institution Study of the Effects of Povidone Iodine Oral Gargles and Nasal Rinses on Viral Load in Patients With COVID-19",WITHDRAWN,,PHASE2,0.0,ACTUAL,NYU Langone Health,,4.0,,This study was withdrawn by the institution to minimize risk to patients and staff with regard to COVID-19.,f,,,,t,t,f,,,t,,,Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.,"Requests should be directed to scott.rickert@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.",,YES,The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: \[contact information for PI or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,OTHER,,,,,,,2020,0.0
NCT04430933,,2020-06-11,,,2021-08-11,2020-06-11,2020-06-16,ACTUAL,,,,,,,2021-08-11,2021-08-18,ACTUAL,2021-12-06,ESTIMATED,2021-12-06,2021-08,2021-08-31,2022-10-30,ESTIMATED,2022-10-30,2022-06-30,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,A Safety and Tolerability Study of NC318 in Combination With Chemotherapy for Subjects With Advanced or Metastatic NSCLC,A Phase 1/2 Study of NC318 in Combination With Chemotherapy for Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"NextCure, Inc.",,3.0,,"Upon reviewing current available combo studies, the sponsor decided to prioritize different combo study.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,INDUSTRY,,,,,,,2022,0.0
NCT04917055,,2021-05-28,,,2023-11-01,2021-06-06,2021-06-08,ACTUAL,,,,,,,2023-11-01,2023-11-07,ACTUAL,2021-06-07,ACTUAL,2021-06-07,2023-11,2023-11-30,2022-06-07,ACTUAL,2022-06-07,2022-06-07,ACTUAL,2022-06-07,,INTERVENTIONAL,,,iPACK Block With Dexamethasone For Total Knee Replacement,Impact of Adding iPACK Block With Dexamethasone to Existing APS Multimodal Analgesia Protocol for Patients Undergoing Total Knee Arthroplasty,TERMINATED,,PHASE4,14.0,ACTUAL,"University of California, San Diego",,2.0,,staffing,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,OTHER,,,,,,,2022,0.0
NCT05602961,,2022-10-28,,,2023-08-08,2022-10-31,2022-11-02,ACTUAL,,,,,,,2023-08-08,2023-08-14,ACTUAL,2023-02-21,ESTIMATED,2023-02-21,2023-08,2023-08-31,2024-09,ESTIMATED,2024-09-30,2024-09,ESTIMATED,2024-09-30,,INTERVENTIONAL,,,A Phase I/II Study of GLB-COV2-043 as a COVID-19 Vaccine Booster,"A Phase I/II Partially Randomized, Active-controlled Observer-blind, Dose-selection, Safety and Immunogenicity Study of GLB-COV2-043, an mRNA Vaccine Candidate Against SARS-CoV-2, Administered as a Single-vaccination Booster to Previously Vaccinated Adults",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"GreenLight Biosciences, Inc.",,4.0,,to prioritize other programs.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,INDUSTRY,,,,,,,2024,0.0
NCT04501094,,2020-08-05,2022-01-18,,2022-02-25,2020-08-05,2020-08-06,ACTUAL,2022-02-25,2022-03-22,ACTUAL,,,,2022-02-25,2022-03-22,ACTUAL,2020-10-26,ACTUAL,2020-10-26,2022-02,2022-02-28,2021-10-13,ACTUAL,2021-10-13,2021-01-19,ACTUAL,2021-01-19,,INTERVENTIONAL,,,A Phase II Study of Bintrafusp Alfa (M7824) in Checkpoint Inhibitor Naive and Refractory Subjects With Urothelial Carcinoma,A Phase II Study of Bintrafusp Alfa (M7824) in Checkpoint Inhibitor Naive and Refractory Subjects With Urothelial Carcinoma,TERMINATED,,PHASE2,2.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,Because of the low accrual and the safety concerns we closed the study.,f,,,,f,t,f,,,,,,Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).~Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.,,YES,"All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).",2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,NIH,,,,,,,2021,0.0
NCT03886220,,2019-03-20,2022-03-04,,2022-03-04,2019-03-20,2019-03-22,ACTUAL,2022-03-04,2022-03-31,ACTUAL,,,,2022-03-04,2022-03-31,ACTUAL,2019-04-12,ACTUAL,2019-04-12,2022-03,2022-03-31,2021-04-28,ACTUAL,2021-04-28,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women,A Phase 4 Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women,COMPLETED,,PHASE4,82.0,ACTUAL,AbbVie,,2.0,,,f,,,,f,t,f,,,t,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,INDUSTRY,,,,,,,2021,1.0
NCT04086342,,2019-08-29,,,2020-06-01,2019-09-09,2019-09-11,ACTUAL,,,,,,,2020-06-01,2020-06-04,ACTUAL,2020-01-24,ESTIMATED,2020-01-24,2019-08,2019-08-31,2021-01-26,ESTIMATED,2021-01-26,2021-01-26,ESTIMATED,2021-01-26,,INTERVENTIONAL,,,CHI-902 for Treatment of Social Anxiety Disorder,CHI-902 for Treatment of Social Anxiety Disorder - A Phase IIb Randomized Double-Blind Placebo-Controlled Clinical Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,Canopy Growth Corporation,,2.0,,Changes in pipeline,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,INDUSTRY,,,,,,,2021,0.0
NCT04047303,,2019-07-29,,,2024-07-02,2019-08-05,2019-08-06,ACTUAL,,,,,,,2024-07-02,2024-07-05,ACTUAL,2020-01-02,ACTUAL,2020-01-02,2024-07,2024-07-31,2024-06-03,ACTUAL,2024-06-03,2024-06-03,ACTUAL,2024-06-03,,INTERVENTIONAL,,,"CNS Penetration, PK and PD of Preoperative CC-90010 in Progressive/Recurrent Diffuse Astrocytoma, Anaplastic Astrocytoma and Glioblastoma","A Phase 1, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics and Central Nervous System (CNS) Penetration of CC-90010 in Preoperative Subjects With Progressive or Recurrent Who Grade II Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma and Recurrent Glioblastoma Scheduled for Resection",TERMINATED,,PHASE1,20.0,ACTUAL,Celgene,,1.0,,Business objectives have changed.,f,,,,t,t,f,,,,,,See Plan Description,See Plan Description,https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,INDUSTRY,,,,,,,2024,0.0
NCT03243838,,2017-08-05,,,2022-01-29,2017-08-08,2017-08-09,ACTUAL,,,,,,,2022-01-29,2022-02-02,ACTUAL,2018-08-01,ACTUAL,2018-08-01,2022-01,2022-01-31,2021-12-31,ACTUAL,2021-12-31,2021-10-13,ACTUAL,2021-10-13,,INTERVENTIONAL,LANCET,,Low-dose Apatinib Combined With Neoadjuvant Chemotherapy in the Treatment of Early Triple Negative Breast Cancer,"Low-dose Apatinib Combined With Neoadjuvant Chemotherapy in the Treatment of Early Triple Negative Breast Cancer (LANCET): A Multicenter, Single-arm, Phase II Trial",COMPLETED,,PHASE2,31.0,ACTUAL,Guangdong Provincial People's Hospital,,1.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,OTHER,,,,,,,2021,1.0
NCT01265849,,2010-12-22,2022-03-18,,2022-08-17,2010-12-22,2010-12-23,ESTIMATED,2022-08-17,2022-08-19,ACTUAL,,,,2022-08-17,2022-08-19,ACTUAL,2010-12,ACTUAL,2010-12-31,2022-08,2022-08-31,2020-12-04,ACTUAL,2020-12-04,2020-05-15,ACTUAL,2020-05-15,,INTERVENTIONAL,IT-MATTERS,"Five randomized subjects were excluded due to the Crimean war (4 cases could not be followed) and one USA case where the Principal Investigator did not sign the full CRF, which left 923 ITT subjects in the study.","Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity",Phase III Study of LI [Multikine®] Plus SOC (Surgery + Radiotherapy or Surgery + Concurrent Radiochemotherapy) in Subjects With Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate vs. SOC Only,COMPLETED,,PHASE3,928.0,ACTUAL,CEL-SCI Corporation,,3.0,,,f,,,,t,,,,,,,,,,,NO,There is no plan,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,INDUSTRY,,,,,,,2020,1.0
NCT04809220,,2021-03-19,2023-08-24,,2024-04-25,2021-03-19,2021-03-22,ACTUAL,2023-08-24,2023-09-21,ACTUAL,,,,2024-04-25,2024-05-22,ACTUAL,2021-04-13,ACTUAL,2021-04-13,2024-04,2024-04-30,2023-04-26,ACTUAL,2023-04-26,2022-10-01,ACTUAL,2022-10-01,,INTERVENTIONAL,AWARD-JPN,"All randomly assigned participants, excluding the GCP compliance investigative site, who were exposed to at least 1 dose of study intervention.",A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes,"A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Two Doses of Dulaglutide in Combination With a Single Oral Antihyperglycemic Medication or as Monotherapy in Japanese Patients With Type 2 Diabetes Mellitus (AWARD-JPN: Assessment of Weekly Administration of LY2189265 in Diabetes - JAPAN)",COMPLETED,,PHASE3,591.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,INDUSTRY,,,,,,,2023,1.0
NCT04875338,,2021-04-29,,,2023-03-24,2021-05-05,2021-05-06,ACTUAL,,,,,,,2023-03-24,2023-03-27,ACTUAL,2021-01-01,ACTUAL,2021-01-01,2023-03,2023-03-31,2023-01-01,ACTUAL,2023-01-01,2023-01-01,ACTUAL,2023-01-01,,INTERVENTIONAL,,,Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial,"Platelet-rich Plasma, Glucocorticoid, Saline Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial",COMPLETED,,PHASE3,40.0,ACTUAL,Istanbul University,,3.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,OTHER,,,,,,,2023,0.0
NCT02203513,,2014-07-29,2022-07-14,,2022-08-11,2014-07-29,2014-07-30,ESTIMATED,2022-08-11,2022-09-10,ACTUAL,,,,2022-08-11,2022-09-10,ACTUAL,2015-01-20,ACTUAL,2015-01-20,2022-08,2022-08-31,2021-08-27,ACTUAL,2021-08-27,2021-08-27,ACTUAL,2021-08-27,,INTERVENTIONAL,,"Cohorts 5 \& 6 are combined because they are for platinum resistant BRCA wild type high grade serous ovarian cancer (HGSOC) participants, literally the same population. Only difference between the two cohorts is cohort 5 is a research biopsy cohort \& cohort 6 had no safely biopsiable disease. Given that Eli Lilly prematurely terminated the study we could not enroll enough number of participants for both cohorts. Thus, it is appropriate and scientifically relevant to report the data in one group.","A Phase II Single Arm Pilot Study of the Chk1/2 Inhibitor (LY2606368) in BRCA1/2 Mutation Associated Breast or Ovarian Cancer, Triple Negative Breast Cancer, High Grade Serous Ovarian Cancer, and Metastatic Castrate-Resistant Prostate Cancer","A Phase II Single Arm Pilot Study of the Chk1/2 Inhibitor (LY2606368) In BRCA1/2 Mutation Associated Breast or Ovarian Cancer, Triple Negative Breast Cancer, and High Grade Serous Ovarian Cancer",TERMINATED,,PHASE2,111.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,Eli Lilly prematurely terminated the study.,f,,,,f,t,f,,,,,,Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol genomic data sharing plan (GDS) for as long as database is active.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).~Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.,,YES,"For All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.~In addition, all large-scale genomic sequencing data will be shared with subscribers to database of Genotypes and Phenotypes (dbGaP).",2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,NIH,,,,,,,2021,0.0
NCT02947880,,2016-10-25,,,2021-06-01,2016-10-27,2016-10-28,ESTIMATED,,,,,,,2021-06-01,2021-06-02,ACTUAL,2016-12,ACTUAL,2016-12-31,2017-08,2017-08-31,2020-06,ACTUAL,2020-06-30,2019-12,ACTUAL,2019-12-31,,INTERVENTIONAL,BUMAUTEP,,Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology,"Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology : Multicenter and Double Blind-study With Randomized Parallel Group, Against Placebo.",WITHDRAWN,,PHASE2,0.0,ACTUAL,"University Hospital, Limoges",,2.0,,the recently feasibility study shows that the number of patients is insufficient in the centers,f,,,,t,,,,,,,,,,,,,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,OTHER,,,,,,,2020,0.0
NCT04369794,,2020-04-27,,,2023-11-27,2020-04-28,2020-04-30,ACTUAL,,,,,,,2023-11-27,2023-11-30,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2023-11,2023-11-30,2023-08-02,ACTUAL,2023-08-02,2022-06-04,ACTUAL,2022-06-04,,INTERVENTIONAL,BATTLE,,"COVID-19: BCG As Therapeutic Vaccine, Transmission Limitation, and Immunoglobulin Enhancement","COVID-19: BCG As Therapeutic Vaccine, Transmission Limitation, and Immunoglobulin Enhancement",COMPLETED,,PHASE4,400.0,ACTUAL,"University of Campinas, Brazil",,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,OTHER,,,,,,,2023,1.0
NCT02912104,,2016-09-06,,,2023-02-27,2016-09-20,2016-09-23,ESTIMATED,,,,,,,2023-02-27,2023-03-01,ACTUAL,2020-06-20,ACTUAL,2020-06-20,2023-02,2023-02-28,2023-01-05,ACTUAL,2023-01-05,2022-01-05,ACTUAL,2022-01-05,,INTERVENTIONAL,POF,,A Therapeutic Trial of Human Amniotic Epithelial Cells Transplantation for Primary Ovarian Failure,A Therapeutic Trial of Human Amniotic Epithelial Cells Transplantation for Primary Ovarian Failure,COMPLETED,,PHASE1,36.0,ACTUAL,International Peace Maternity and Child Health Hospital,,1.0,,,f,,,,t,f,f,,,,,,2 years,public,https://clinicaltrials.gov,YES,The public can require the data and protocol from clinicaltrials.gov posted by investigator,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,OTHER,,,,,,,2023,1.0
NCT03852524,,2019-02-04,2021-09-09,,2021-10-07,2019-02-21,2019-02-25,ACTUAL,2021-09-09,2021-10-06,ACTUAL,,,,2021-10-07,2021-10-27,ACTUAL,2019-02-21,ACTUAL,2019-02-21,2021-10,2021-10-31,2021-05-12,ACTUAL,2021-05-12,2021-04-04,ACTUAL,2021-04-04,,INTERVENTIONAL,,,Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention,"Double-Blind, Randomized Trial of Peri-operative Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention After Adult Spinal Arthrodesis",COMPLETED,,PHASE2,82.0,ACTUAL,Ohio State University,,2.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,OTHER,,,,,,,2021,1.0
NCT04410445,,2020-05-27,2023-02-27,,2023-03-31,2020-05-27,2020-06-01,ACTUAL,2023-03-31,2023-04-21,ACTUAL,,,,2023-03-31,2023-04-21,ACTUAL,2020-07-27,ACTUAL,2020-07-27,2023-03,2023-03-31,2022-09-22,ACTUAL,2022-09-22,2022-09-22,ACTUAL,2022-09-22,,INTERVENTIONAL,PIVOT-12,,Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence,"A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)",TERMINATED,,PHASE3,765.0,ACTUAL,Nektar Therapeutics,,2.0,,(Sponsor decision),f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,INDUSTRY,,,,,,,2022,0.0
NCT05413369,,2022-06-07,,,2024-01-21,2022-06-07,2022-06-10,ACTUAL,,,,,,,2024-01-21,2024-01-23,ACTUAL,2022-07-07,ACTUAL,2022-07-07,2024-01,2024-01-31,2023-10-20,ACTUAL,2023-10-20,2023-10-20,ACTUAL,2023-10-20,,INTERVENTIONAL,,,iGlarLixi vs IDegAsp in Chinese Participants After OAD(s),"A Randomized, 24 Weeks, Active-controlled, Open-label, 2-arm Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to IDegAsp in Chinese Type 2 Diabetes Mellitus Participants Insufficiently Controlled With Oral Antidiabetic Drug(s)",COMPLETED,,PHASE3,582.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,INDUSTRY,,,,,,,2023,1.0
NCT02367794,,2015-02-13,2019-09-25,,2022-03-17,2015-02-13,2015-02-20,ESTIMATED,2019-10-21,2019-11-12,ACTUAL,,,,2022-03-17,2022-03-21,ACTUAL,2015-06-11,ACTUAL,2015-06-11,2022-03,2022-03-31,2021-02-17,ACTUAL,2021-02-17,2018-10-03,ACTUAL,2018-10-03,,INTERVENTIONAL,,,A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131],"A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer",COMPLETED,,PHASE3,1021.0,ACTUAL,Hoffmann-La Roche,,3.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,INDUSTRY,,,,,,,2021,1.0
NCT04905212,,2021-05-21,,,2023-11-29,2021-05-23,2021-05-27,ACTUAL,,,,,,,2023-11-29,2023-12-06,ACTUAL,2021-11-04,ACTUAL,2021-11-04,2023-11,2023-11-30,2023-11-09,ACTUAL,2023-11-09,2023-11-09,ACTUAL,2023-11-09,,INTERVENTIONAL,,,A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy,"A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) With an Optional Open Label Extension in Subjects With IgA Nephropathy",TERMINATED,,PHASE2,15.0,ACTUAL,"RemeGen Co., Ltd.",,3.0,,Decision that continuing with the study would not generate useful data,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,INDUSTRY,,,,,,,2023,0.0
NCT02677688,,2016-01-28,,,2022-03-24,2016-02-04,2016-02-09,ESTIMATED,,,,,,,2022-03-24,2022-03-25,ACTUAL,2016-01,ACTUAL,2016-01-31,2022-03,2022-03-31,2021-07-01,ACTUAL,2021-07-01,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,LUPUS CTL EBV,,Autologous EBV-specific Cytotoxic T Cells for the Treatment of Systemic Lupus Erythematosus (SLE),Restauration of EBV Control in SLE Phase 1-2 Trial Evaluating Adoptive Transfer of Autologous EBV- Specific Cytotoxic T Lymphocytes in SLE Treatment,TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,Nantes University Hospital,,1.0,,completed inclusions,f,,,,f,,,,,,,,,,,NO,,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,OTHER,,,,,,,2021,0.0
NCT02291055,,2014-11-06,2023-02-20,,2023-02-20,2014-11-13,2014-11-14,ESTIMATED,2023-02-20,2023-03-20,ACTUAL,,,,2023-02-20,2023-03-20,ACTUAL,2015-04,ACTUAL,2015-04-30,2023-02,2023-02-28,2020-11-20,ACTUAL,2020-11-20,2019-07-09,ACTUAL,2019-07-09,,INTERVENTIONAL,,All Treated Population included participants who received at least 1 dose of study drug.,A Study of ADXS11-001 or MEDI4736 Alone or Combination In Cervical or Human Papillomavirus (HPV)+ Head & Neck Cancer,Phase 1-2 Study of ADXS11-001 or MEDI4736 Alone or Combination In Previously Treated Locally Advanced or Metastatic Cervical or HPV+ Head & Neck Cancer,TERMINATED,,PHASE1/PHASE2,75.0,ACTUAL,"Advaxis, Inc.","Based on a discussion with the FDA, a 1-year duration of the Listeria monocytogenes surveillance period was considered sufficient (instead of protocol specified 3-years period) to monitor and characterize any potential risk associated with delayed listeremia, and therefore, the study was terminated early.",5.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:46:52.467367,2024-10-15 10:46:52.467367,INDUSTRY,,,,,,,2020,0.0
NCT05228834,,2022-01-10,2024-04-08,,2024-04-08,2022-01-27,2022-02-08,ACTUAL,2024-04-08,2024-05-02,ACTUAL,,,,2024-04-08,2024-05-02,ACTUAL,2022-06-24,ACTUAL,2022-06-24,2024-03,2024-03-31,2022-09-30,ACTUAL,2022-09-30,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,,"Only one participant was enrolled. Hence, data cannot be reported due to risk of re-identification of participant.",Voxelotor Neurocognitive Function Study,"A Phase 3b, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Treatment Effect of Voxelotor on Neurocognitive Function in Pediatric Participants 8 to < 18 Years of Age With Sickle Cell Disease",TERMINATED,,PHASE3,1.0,ACTUAL,Pfizer,The study was terminated due to slow enrollment and resource reprioritization at L-GBT. Based on the low enrolment data was not reported due to risk of re-identification of participant.,2.0,,Data will not inform further development of Voxelotor,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,INDUSTRY,,,,,,,2022,0.0
NCT04870112,,2021-04-16,,,2024-03-07,2021-04-30,2021-05-03,ACTUAL,,,,,,,2024-03-07,2024-03-08,ACTUAL,2021-06-28,ACTUAL,2021-06-28,2024-02,2024-02-29,2023-08-30,ACTUAL,2023-08-30,2023-08-30,ACTUAL,2023-08-30,,INTERVENTIONAL,SCope-D1,,A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer,"A Phase 1/2a, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Subcutaneous Durvalumab in Patients With Non-Small Cell and Small Cell Lung Cancer - SCope-D1",TERMINATED,,PHASE1,18.0,ACTUAL,AstraZeneca,,2.0,,"AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 was not initiated",f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,INDUSTRY,,,,,,,2023,0.0
NCT03331666,,2017-10-20,2021-01-22,,2021-03-05,2017-10-31,2017-11-06,ACTUAL,2021-03-05,2021-04-01,ACTUAL,,,,2021-03-05,2021-04-01,ACTUAL,2018-11-16,ACTUAL,2018-11-16,2021-03,2021-03-31,2020-02-04,ACTUAL,2020-02-04,2020-02-04,ACTUAL,2020-02-04,,INTERVENTIONAL,,"Patients who have a clinical diagnosis of familial hypercholesterolemia and are referred for treatment with PCSK9 inhibitor, with LDL cholesterol levels ≥70 mg/dl on baseline treatment with statins and/or ezetimibe or intolerant to statin and/or ezetimibe.",Impact of LDL-cholesterol Lowering on Platelet Activation,Impact of LDL-cholesterol Lowering on Platelet Activation,TERMINATED,,PHASE4,4.0,ACTUAL,Columbia University,,2.0,,Terminated Prematurely due to COVID-19,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,OTHER,,,,,,,2020,0.0
NCT04365985,,2020-04-26,2022-01-12,,2022-01-12,2020-04-26,2020-04-28,ACTUAL,2022-01-12,2022-01-26,ACTUAL,,,,2022-01-12,2022-01-26,ACTUAL,2020-04-29,ACTUAL,2020-04-29,2022-01,2022-01-31,2021-04-01,ACTUAL,2021-04-01,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,SINK COVID-19,,Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19,Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19,TERMINATED,,PHASE2,70.0,ACTUAL,William Beaumont Hospitals,,3.0,,"Because of the decrease in COVID cases, enrollment is extremely low. Given the current study design, it is not possible to gather data necessary to answer the question about whether study treatment reduces mortality",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,OTHER,,,,,,,2021,0.0
NCT04863014,,2021-04-26,2024-02-12,,2024-05-20,2021-04-26,2021-04-28,ACTUAL,2024-05-20,2024-05-22,ACTUAL,,,,2024-05-20,2024-05-22,ACTUAL,2021-07-12,ACTUAL,2021-07-12,2024-05,2024-05-31,2023-02-15,ACTUAL,2023-02-15,2023-02-15,ACTUAL,2023-02-15,,INTERVENTIONAL,,The safety analysis set (SAF) included all participants who received at least 1 dose or part of a dose of double-blind study drug.,Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis,"A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis",TERMINATED,,PHASE2,21.0,ACTUAL,Regeneron Pharmaceuticals,The sponsor terminated the study early due to enrollment issues.,2.0,,Sponsor Decision,f,,,,t,t,f,,,,,,"When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.",Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf,https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,INDUSTRY,,,,,,,2023,0.0
NCT05460871,,2022-07-13,2024-02-06,,2024-03-15,2022-07-13,2022-07-15,ACTUAL,2024-03-15,2024-03-18,ACTUAL,,,,2024-03-15,2024-03-18,ACTUAL,2023-02-21,ACTUAL,2023-02-21,2024-03,2024-03-31,2024-01-25,ACTUAL,2024-01-25,2024-01-25,ACTUAL,2024-01-25,,INTERVENTIONAL,,,Pregabalin for Central Sensitization in TKA,Evaluating the Efficacy and Safety of Pregabalin in Total Knee Arthroplasty Patients With Central Sensitization,TERMINATED,,PHASE4,20.0,ACTUAL,University of Iowa,,2.0,,Enrollment lower than anticipated; none of the subjects completing the study.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,OTHER,,,,,,,2024,0.0
NCT06206278,,2023-11-29,,,2024-08-12,2024-01-04,2024-01-16,ACTUAL,,,,,,,2024-08-12,2024-08-14,ACTUAL,2023-10-19,ACTUAL,2023-10-19,2024-08,2024-08-31,2024-05-31,ACTUAL,2024-05-31,2024-05-31,ACTUAL,2024-05-31,,INTERVENTIONAL,,,Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma,"A Phase II, Multicenter, Open-Label, Single Arm Study of Oral Infigratinib Monotherapy in Patients With Locally Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, Who Harboring FGFR2 Gene Amplification",TERMINATED,,PHASE2,6.0,ACTUAL,LianBio LLC,,1.0,,Business Reason,f,,,,,f,f,,,,,,,,,,,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,INDUSTRY,,,,,,,2024,0.0
NCT04347889,,2020-04-13,,,2020-10-28,2020-04-13,2020-04-15,ACTUAL,,,,,,,2020-10-28,2020-11-02,ACTUAL,2020-04-20,ESTIMATED,2020-04-20,2020-10,2020-10-31,2020-12-30,ESTIMATED,2020-12-30,2020-12-30,ESTIMATED,2020-12-30,,INTERVENTIONAL,,,Preventing COVID-19 in Healthcare Workers With HCQ: A RCT,Prophylactic Hydroxychloroquine vs Vitamin C in Healthcare Workers at Risk of COVID-19: A RCT,WITHDRAWN,,PHASE2,0.0,ACTUAL,Stony Brook University,,2.0,,"Evidence that HCQ ineffective, loss of HCW interest,",f,,,,t,t,f,,,t,,,,,,,,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,OTHER,,,,,,,2020,0.0
NCT05233566,,2022-02-03,2024-02-15,,2024-03-13,2022-02-03,2022-02-10,ACTUAL,2024-03-13,2024-04-10,ACTUAL,,,,2024-03-13,2024-04-10,ACTUAL,2022-04-25,ACTUAL,2022-04-25,2024-03,2024-03-31,2023-03-08,ACTUAL,2023-03-08,2023-03-08,ACTUAL,2023-03-08,,INTERVENTIONAL,K-PASS,,Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility Trial,Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility Trial,COMPLETED,,PHASE3,32.0,ACTUAL,Washington University School of Medicine,,2.0,,,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,OTHER,,,,,,,2023,1.0
NCT03385239,,2017-12-01,2022-11-19,2020-11-19,2022-12-19,2017-12-20,2017-12-28,ACTUAL,2022-12-19,2023-01-11,ACTUAL,2022-12-19,2023-01-11,ACTUAL,2022-12-19,2023-01-11,ACTUAL,2018-01-30,ACTUAL,2018-01-30,2022-12,2022-12-31,2020-02-25,ACTUAL,2020-02-25,2019-11-25,ACTUAL,2019-11-25,,INTERVENTIONAL,,Full analysis set (FAS) included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).,Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD),"A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Phase 2 Study of ISIS 678354 Administered Subcutaneously to Patients With Hypertriglyceridemia and Established Cardiovascular Disease (CVD) or at a High Risk for CVD",COMPLETED,,PHASE2,114.0,ACTUAL,Akcea Therapeutics,,5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,INDUSTRY,,,,,,,2020,1.0
NCT04214093,,2019-12-12,,,2023-08-01,2019-12-27,2019-12-30,ACTUAL,,,,,,,2023-08-01,2023-08-02,ACTUAL,2019-12-16,ACTUAL,2019-12-16,2023-07,2023-07-31,2021-06-18,ACTUAL,2021-06-18,2021-06-18,ACTUAL,2021-06-18,,INTERVENTIONAL,,,A Study of AZD0466 in Patients With Advanced Hematologic or Solid Tumors,"A Phase I, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Doses of AZD0466 in Patients With Advanced Hematologic or Solid Tumors",TERMINATED,,PHASE1,9.0,ACTUAL,AstraZeneca,,2.0,,Strategic change to clinical development plan,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,INDUSTRY,,,,,,,2021,0.0
NCT03446599,,2018-02-20,,,2020-02-27,2018-02-20,2018-02-27,ACTUAL,,,,,,,2020-02-27,2020-03-02,ACTUAL,2019-11,ESTIMATED,2019-11-30,2020-02,2020-02-29,2020-06-30,ESTIMATED,2020-06-30,2020-05,ESTIMATED,2020-05-31,,INTERVENTIONAL,,,Hemodynamic Effects of Methylene Blue vs Hydroxocobalamin in Patients at Risk of Vasoplegia During Cardiac Surgery,"A Randomized, Placebo-controlled Single-center Pilot Study of the Hemodynamic Effects of Methylene Blue vs Hydroxocobalamin in Patients at Risk of Vasoplegia Undergoing Cardiac Surgery With Cardiopulmonary Bypass",WITHDRAWN,,PHASE2,0.0,ACTUAL,Dartmouth-Hitchcock Medical Center,,3.0,,Lack of funding,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,OTHER,,,,,,,2020,0.0
NCT04459702,,2020-06-25,,,2021-04-06,2020-07-04,2020-07-07,ACTUAL,,,,,,,2021-04-06,2021-04-08,ACTUAL,2020-07,ESTIMATED,2020-07-31,2021-04,2021-04-30,2021-12,ESTIMATED,2021-12-31,2021-07,ESTIMATED,2021-07-31,,INTERVENTIONAL,,,A Study of Combination Therapies to Treat COVID-19 Infection,"A Phase IIa Randomized, Controlled Study of Combination Therapies to Treat COVID-19 Infection",WITHDRAWN,,PHASE2,0.0,ACTUAL,ProgenaBiome,,2.0,,Was never started,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,OTHER,,,,,,,2021,0.0
NCT02370498,,2015-02-23,2018-10-22,,2022-05-12,2015-02-23,2015-02-25,ESTIMATED,2018-10-22,2018-11-20,ACTUAL,,,,2022-05-12,2022-06-06,ACTUAL,2015-05-11,ACTUAL,2015-05-11,2022-05,2022-05-31,2021-06-10,ACTUAL,2021-06-10,2017-10-26,ACTUAL,2017-10-26,,INTERVENTIONAL,,,A Study of Pembrolizumab (MK-3475) Versus Paclitaxel for Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine (MK-3475-061/KEYNOTE-061),"A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine",COMPLETED,,PHASE3,592.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,INDUSTRY,,,,,,,2021,1.0
NCT04281524,,2020-02-21,,,2020-03-23,2020-02-21,2020-02-24,ACTUAL,,,,,,,2020-03-23,2020-03-25,ACTUAL,2020-03,ESTIMATED,2020-03-31,2020-03,2020-03-31,2021-10,ESTIMATED,2021-10-31,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,,,A Clinical Study to Test the Efficacy and Safety of CSL312 on Catheter-associated Blood Clot Formation in Subjects With Cancer Who Receive Chemotherapy Through a PICC Line,"A Phase 1b, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, and Pharmacokinetics of CSL312 in the Prevention of Peripherally Inserted Central Catheter (PICC)-Associated Thrombosis in Subjects With Cancer",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,CSL Behring,,5.0,,Business decision non-safety related.,f,,,,t,f,f,,,,,,IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.,Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.~An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.~The requesting party must execute an appropriate data sharing agreement before IPD will be made available.,,YES,"CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.~Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.~If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.",2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,INDUSTRY,,,,,,,2021,0.0
NCT02943733,,2016-10-21,,,2022-09-21,2016-10-21,2016-10-25,ESTIMATED,,,,,,,2022-09-21,2022-09-23,ACTUAL,2017-08-22,ACTUAL,2017-08-22,2022-09,2022-09-30,2022-01-31,ACTUAL,2022-01-31,2020-11-07,ACTUAL,2020-11-07,,INTERVENTIONAL,,,Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic NETs,Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic Neuroendocrine Tumors,TERMINATED,,PHASE1,18.0,ACTUAL,"University of Wisconsin, Madison",,1.0,,"closed per sponsor request, for slow enrollment",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:52:23.471115,2024-10-15 10:52:23.471115,OTHER,,,,,,,2022,0.0
NCT03768531,,2018-12-05,,,2020-04-09,2018-12-06,2018-12-07,ACTUAL,,,,,,,2020-04-09,2020-04-13,ACTUAL,2019-06-14,ACTUAL,2019-06-14,2020-04,2020-04-30,2023-01,ESTIMATED,2023-01-31,2023-01,ESTIMATED,2023-01-31,,INTERVENTIONAL,,,Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer,Safety and Tolerability Study of Combination Nivolumab and Cabiralizumab as Neoadjuvant and Adjuvant Therapy for Resectable Biliary Tract Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,2.0,,No subjects were enrolled,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,OTHER,,,,,,,2023,0.0
NCT04262895,,2020-02-05,,,2021-10-18,2020-02-05,2020-02-10,ACTUAL,,,,,,,2021-10-18,2021-10-26,ACTUAL,2021-10-01,ACTUAL,2021-10-01,2021-10,2021-10-31,2021-10-15,ACTUAL,2021-10-15,2021-10-15,ACTUAL,2021-10-15,,INTERVENTIONAL,,,TTI-0102 for Veterans With TBI,"TTI-0102, a Cysteamine Precursor for Mild to Moderate TBI: Dosing and Feasibility Study",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,VA Office of Research and Development,,3.0,,Funding withdrawn due to delay in FDA IND submission,f,,,,f,t,f,,,f,,,"Following study completion, indefinitely.",Upon request.,,YES,"A de-identified, anonymized dataset will be created and shared upon request.",2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,FED,,,,,,,2021,0.0
NCT04184622,,2019-12-02,2023-03-30,,2024-07-23,2019-12-02,2019-12-03,ACTUAL,2023-03-30,2023-04-24,ACTUAL,,,,2024-07-23,2024-08-01,ACTUAL,2019-12-04,ACTUAL,2019-12-04,2024-07,2024-07-31,2024-07-06,ACTUAL,2024-07-06,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,SURMOUNT-1,All participants who are randomly assigned a study drug.,A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight,"Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight- Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)",COMPLETED,,PHASE3,2539.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,INDUSTRY,,,,,,,2024,1.0
NCT03696758,,2018-10-03,2021-01-14,,2021-02-24,2018-10-03,2018-10-05,ACTUAL,2021-02-22,2021-02-25,ACTUAL,,,,2021-02-24,2021-03-17,ACTUAL,2018-10-30,ACTUAL,2018-10-30,2021-02,2021-02-28,2020-02-24,ACTUAL,2020-02-24,2020-02-24,ACTUAL,2020-02-24,,INTERVENTIONAL,,,Improving Right Ventricular Function in Young Adults Born Preterm,Improving Right Ventricular Function in Young Adults Born Preterm: A Pilot Study,COMPLETED,,PHASE2,10.0,ACTUAL,"University of Wisconsin, Madison",,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,OTHER,,,,,,,2020,1.0
NCT04471415,,2020-06-25,,,2023-06-09,2020-07-14,2020-07-15,ACTUAL,,,,,,,2023-06-09,2023-06-12,ACTUAL,2020-08-31,ACTUAL,2020-08-31,2023-06,2023-06-30,2023-03-28,ACTUAL,2023-03-28,2023-03-28,ACTUAL,2023-03-28,,INTERVENTIONAL,,,Study to Investigate DRP-104 in Adults With Advanced Solid Tumors,"Phase 1 and Phase 2a, First-in-human Study of DRP-104, a Glutamine Antagonist, in Adult Patients With Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,61.0,ACTUAL,"Dracen Pharmaceuticals, Inc.",,4.0,,Company decision to closing study and discontinue further patient enrollment.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,INDUSTRY,,,,,,,2023,0.0
NCT03227562,,2017-07-14,,,2022-08-02,2017-07-21,2017-07-24,ACTUAL,,,,,,,2022-08-02,2022-08-04,ACTUAL,2017-09-01,ACTUAL,2017-09-01,2022-08,2022-08-31,2021-12-01,ACTUAL,2021-12-01,2021-09-01,ACTUAL,2021-09-01,,INTERVENTIONAL,,,Is Initial Response to Low Dose Risperidone Predictive for Outcome in Anxiety?,Evaluation of Predictability of the Initial Response to a Low Dose of Risperidone on the Middle Term Efficiency in Anxious Subjects,TERMINATED,,PHASE3,120.0,ACTUAL,Institut de Recherche Biomedicale des Armees,,2.0,,not enough patient,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,OTHER_GOV,,,,,,,2021,0.0
NCT04507347,,2020-07-16,,,2022-12-23,2020-08-07,2020-08-11,ACTUAL,,,,,,,2022-12-23,2022-12-27,ACTUAL,2021-06,ESTIMATED,2021-06-30,2020-08,2020-08-31,2024-06,ESTIMATED,2024-06-30,2024-06,ESTIMATED,2024-06-30,,INTERVENTIONAL,,,"Efficacy and Safety of TRC041266 in Patients With Heart Failure, LVEF ≥40%, Diastolic Dysfunction and Type 2 Diabetes Mellitus","Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicentre Study to Evaluate the Efficacy and Safety of TRC041266 Compared to Placebo in Patients With Chronic Stable Heart Failure, an LVEF ≥40%, Moderate to Severe Diastolic Dysfunction and Type 2 Diabetes Mellitus",WITHDRAWN,,PHASE3,0.0,ACTUAL,Torrent Pharmaceuticals Limited,,2.0,,"Study halted prematurely, prior to enrollment of first participant hence study withdrawn",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,INDUSTRY,,,,,,,2024,0.0
NCT01301183,,2011-02-18,2021-05-29,,2021-06-22,2011-02-18,2011-02-23,ESTIMATED,2021-06-22,2021-07-13,ACTUAL,,,,2021-06-22,2021-07-13,ACTUAL,2011-02,ACTUAL,2011-02-28,2021-06,2021-06-30,2020-03,ACTUAL,2020-03-31,2019-03,ACTUAL,2019-03-31,,INTERVENTIONAL,,,Effects of Anorexia Nervosa on Peak Bone Mass,Effects of Anorexia Nervosa on Peak Bone Mass,COMPLETED,,PHASE3,75.0,ACTUAL,Massachusetts General Hospital,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,OTHER,,,,,,,2020,1.0
NCT02499497,,2015-07-06,2021-08-23,,2021-09-27,2015-07-15,2015-07-16,ESTIMATED,2021-09-27,2021-09-28,ACTUAL,,,,2021-09-27,2021-09-28,ACTUAL,2016-02-29,ACTUAL,2016-02-29,2021-09,2021-09-30,2020-10-31,ACTUAL,2020-10-31,2020-10-31,ACTUAL,2020-10-31,,INTERVENTIONAL,,,A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer,A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer,COMPLETED,,PHASE2,114.0,ACTUAL,Dana-Farber Cancer Institute,,4.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,OTHER,,,,,,,2020,1.0
NCT04372706,,2020-04-23,,,2022-12-09,2020-04-29,2020-05-04,ACTUAL,,,,,,,2022-12-09,2022-12-13,ACTUAL,2020-05-06,ACTUAL,2020-05-06,2022-12,2022-12-31,2022-11-30,ACTUAL,2022-11-30,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,,,RTX-240 Monotherapy and in Combination With Pembrolizumab,Phase 1/2 Study of RTX-240 Monotherapy and in Combination With Pembrolizumab,TERMINATED,,PHASE1/PHASE2,69.0,ACTUAL,Rubius Therapeutics,,4.0,,"Sponsor terminated study during expansion on 11/30/22. RTX-240 was well-tolerated in multiple indications, combinations, and dose levels (69pts). No DLTs, related deaths or SAEs were reported. RTX-240 cleared circulation rapidly.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 21:21:25.66391,2024-10-15 21:21:25.66391,INDUSTRY,,,,,,,2022,0.0
NCT03202147,,2017-06-26,,,2022-02-16,2017-06-26,2017-06-28,ACTUAL,,,,,,,2022-02-16,2022-03-03,ACTUAL,2023-12,ESTIMATED,2023-12-31,2020-04,2020-04-30,2024-12,ESTIMATED,2024-12-31,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Safety and Efficacy of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI),A Phase II Safety and Efficacy Study of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI),WITHDRAWN,,PHASE2,0.0,ACTUAL,"AZTherapies, Inc.",,2.0,,Study halted prematurely prior to initiation but potentially will resume in the future.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:52:23.471115,2024-10-15 10:52:23.471115,INDUSTRY,,,,,,,2024,0.0
NCT03409276,,2018-01-09,2021-10-25,,2022-03-28,2018-01-17,2018-01-24,ACTUAL,2022-03-28,2022-04-25,ACTUAL,,,,2022-03-28,2022-04-25,ACTUAL,2018-03-16,ACTUAL,2018-03-16,2022-03,2022-03-31,2020-10-22,ACTUAL,2020-10-22,2020-05-11,ACTUAL,2020-05-11,,INTERVENTIONAL,,,"Evaluating the Safety and Immunogenicity of Env (A,B,C,A/E)/Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV Vaccines, Given Individually or Co-administered, in Healthy, HIV-1-Uninfected Adults","A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Polyvalent Env (A,B,C,A/E) / Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV-1 Vaccines (PDPHV-201401) as a Prime-boost Regimen or Co-administered in Repeated Doses, in Healthy, HIV-1-Uninfected Adult Participants",COMPLETED,,PHASE1,60.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,6.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,NIH,,,,,,,2020,1.0
NCT04174911,,2019-11-21,,,2022-12-07,2019-11-21,2019-11-22,ACTUAL,,,,,,,2022-12-07,2022-12-09,ACTUAL,2019-01,ESTIMATED,2019-01-31,2022-12,2022-12-31,2020-12,ESTIMATED,2020-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Efficacy of BOL-DP-o-08 in Patients With Endometriosis Syndrome.,"A Randomized Phase 2a, Double-blind, Placebo-Controlled Study Examining the Safety and Efficacy of BOL-DP-o-08 in Patients With Endometriosis Syndrome.",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Breath of Life International Pharma Ltd,,2.0,,covid 19,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 10:52:23.471115,2024-10-15 10:52:23.471115,INDUSTRY,,,,,,,2020,0.0
NCT02211131,,2014-08-05,2020-04-21,2020-04-09,2023-05-09,2014-08-05,2014-08-07,ESTIMATED,2020-05-20,2020-05-28,ACTUAL,2020-04-09,2020-04-14,ACTUAL,2023-05-09,2023-06-05,ACTUAL,2015-02-03,ACTUAL,2015-02-03,2023-05,2023-05-31,2022-04-28,ACTUAL,2022-04-28,2019-04-30,ACTUAL,2019-04-30,,INTERVENTIONAL,,Intent to Treat Analysis Set: all participants who were randomized to either treatment group.,Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma,"A Phase 2, Multicenter, Randomized, Open-label Trial Assessing the Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Resectable, Stage IIIB to IVM1a Melanoma",COMPLETED,,PHASE2,150.0,ACTUAL,Amgen,,2.0,,,f,,,,f,,,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 10:52:23.471115,2024-10-15 10:52:23.471115,INDUSTRY,,,,,,,2022,1.0
NCT05363839,,2022-03-01,,,2023-04-25,2022-05-02,2022-05-06,ACTUAL,,,,,,,2023-04-25,2023-04-27,ACTUAL,2022-05-06,ACTUAL,2022-05-06,2023-01,2023-01-31,2022-11-02,ACTUAL,2022-11-02,2022-11-02,ACTUAL,2022-11-02,,INTERVENTIONAL,,,"To Assess the Safety, Tolerability and Pharmacokinetics of ACH-000029 in Healthy Subjects","A Phase 1, Single-center, Placebo-controlled, Double-blind, Randomized Trial to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of ACH-000029 in Healthy Subjects",TERMINATED,,PHASE1,8.0,ACTUAL,Syneos Health,,2.0,,"Based on the unblinded clinical data, the trial was terminated.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,OTHER,,,,,,,2022,0.0
NCT02520011,,2015-08-06,2021-05-13,,2023-11-13,2015-08-06,2015-08-11,ESTIMATED,2021-07-13,2021-07-15,ACTUAL,,,,2023-11-13,2023-11-15,ACTUAL,2016-03-14,ACTUAL,2016-03-14,2023-11,2023-11-30,2020-02-12,ACTUAL,2020-02-12,2020-02-12,ACTUAL,2020-02-12,,INTERVENTIONAL,,,Alvocidib Biomarker-driven Phase 2 AML Study,"Phase 2, Randomized, Biomarker-driven Clinical Study in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With MCL-1 Dependence ≥30%",TERMINATED,,PHASE2,104.0,ACTUAL,"Sumitomo Pharma America, Inc.",The protocol underwent a few major amendments to shorten time to complete and allow for an expeditious analysis and reporting of outcomes. The study was terminated early Jan 2020 due to marked decrease in enrollment and thus could not reach all of its efficacy endpoints. Only select analyses could be performed. Treatment efficacy was summarized by distributing the safety population into 6 groups based on whether the patients received ACM or CM regimen and their disease stages at study entry.,2.0,,"Due to slow enrollment, the extensive time projected to conclude the study hypothesis rendered the study no longer reasonably feasible to complete.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:52:23.471115,2024-10-15 10:52:23.471115,INDUSTRY,,,,,,,2020,0.0
NCT03780634,,2018-12-18,,,2019-05-02,2018-12-18,2018-12-19,ACTUAL,,,,,,,2019-05-02,2019-05-06,ACTUAL,2019-04-01,ESTIMATED,2019-04-01,2019-03,2019-03-31,2021-12-01,ESTIMATED,2021-12-01,2020-12-01,ESTIMATED,2020-12-01,,INTERVENTIONAL,,,HAIC Plus PD-1 Antibody vs HAIC Plus Sorafenib for Advanced HCC,Hepatic Artery Infusion Chemotherapy Plus Programmed Cell Death Protein-1 (PD-1) Antibody vs Hepatic Artery Infusion Chemotherapy Plus Sorafenib for Advanced Hepatocellular Carcinoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,Sun Yat-sen University,,2.0,,No participants enrolled,f,,,,t,f,f,,,,,,,,,,,2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,OTHER,,,,,,,2021,0.0
NCT04469725,,2020-07-07,,,2024-03-10,2020-07-11,2020-07-14,ACTUAL,,,,,,,2024-03-10,2024-03-12,ACTUAL,2020-12-02,ACTUAL,2020-12-02,2024-03,2024-03-31,2023-07-07,ACTUAL,2023-07-07,2023-07-07,ACTUAL,2023-07-07,,INTERVENTIONAL,,,KN046 (a Humanized PD-L1/CTLA4 Bispecific Single Domain Fc Fusion Protein Antibody) in Subjects With Thymic Carcinoma,"A Phase 2, Open-Label, Multi-Center Study to Evaluate Efficacy, Safety and Tolerability of KN046 in Subjects With Thymic Carcinoma",TERMINATED,,PHASE2,95.0,ACTUAL,"Jiangsu Alphamab Biopharmaceuticals Co., Ltd",,1.0,,"The termination of this study does not involve safety issues. The overall safety of KN046 is good, and no new safety signals have been found. The decision to terminate this study was made due to the adjustment of the sponsor's development strategy.",f,,,,,f,f,,,,,,,,,NO,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,INDUSTRY,,,,,,,2023,0.0
NCT03823703,,2019-01-14,2022-07-06,,2022-08-10,2019-01-29,2019-01-30,ACTUAL,2022-08-10,2022-08-31,ACTUAL,,,,2022-08-10,2022-08-31,ACTUAL,2020-11-04,ACTUAL,2020-11-04,2021-04,2021-04-30,2021-04-05,ACTUAL,2021-04-05,2021-04-05,ACTUAL,2021-04-05,,INTERVENTIONAL,,,"Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)","A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)",TERMINATED,,PHASE2,12.0,ACTUAL,Corcept Therapeutics,"Due to observations related to safety, the study was terminated by the Sponsor prior to completion. The sample size at the time of study termination did not support formal tests to assess statistical differences between treatment groups, and therefore, no efficacy analyses specified in the protocol were performed. Descriptive statistics for efficacy endpoints are provided, but since no patient reached the Week 12 visit, and therefore, descriptive statistics at Week 12 are not presented.",3.0,,"Suspended by sponsor, pending investigation of abnormal laboratory values in patients with NASH",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,INDUSTRY,,,,,,,2021,0.0
NCT05047640,,2021-09-13,2023-04-14,,2024-05-31,2021-09-16,2021-09-17,ACTUAL,2023-06-20,2023-06-22,ACTUAL,,,,2024-05-31,2024-06-04,ACTUAL,2021-09-14,ACTUAL,2021-09-14,2024-05,2024-05-31,2022-10-25,ACTUAL,2022-10-25,2022-10-25,ACTUAL,2022-10-25,,INTERVENTIONAL,,,COVID-19 3rd Dose Vaccine in Transplant Patients,"A Single-Blind, Randomized, Controlled Trial Comparing BNT162b2 vs JNJ-78436735 Vaccine as a Booster Dose After Completion of BNT162b2 Vaccine in Solid Organ Transplant Recipients",TERMINATED,,PHASE3,58.0,ACTUAL,University of Miami,,2.0,,Difficulty in recruitment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,OTHER,,,,,,,2022,0.0
NCT03065712,,2017-02-20,,,2020-05-08,2017-02-27,2017-02-28,ACTUAL,,,,,,,2020-05-08,2020-05-12,ACTUAL,2017-02-22,ACTUAL,2017-02-22,2019-08,2019-08-31,2021-02-20,ESTIMATED,2021-02-20,2020-02-22,ESTIMATED,2020-02-22,,INTERVENTIONAL,,,Test - Retest Reproducibility of 18F Fluoroestradiol (FES) PET,Test - Retest Reproducibility of 18F Fluoroestradiol (FES) PET and Predictive Measure for Endocrine Therapy Response in Patients With Newly Diagnosed Metastatic Breast Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Texas Southwestern Medical Center,,1.0,,Competing clinical trial,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,OTHER,,,,,,,2021,0.0
NCT04097314,,2019-07-05,,,2023-08-02,2019-09-19,2019-09-20,ACTUAL,,,,,,,2023-08-02,2023-08-04,ACTUAL,2019-10-18,ACTUAL,2019-10-18,2023-04,2023-04-30,2023-06-08,ACTUAL,2023-06-08,2023-06-08,ACTUAL,2023-06-08,,INTERVENTIONAL,PRIZE,,Precision Medicine With Zibotentan in Microvascular Angina,"A Randomised, Double-blind, Placebo-controlled, Cross-over Trial of Zibotentan in Microvascular Angina",COMPLETED,,PHASE2,225.0,ACTUAL,NHS Greater Glasgow and Clyde,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,OTHER,,,,,,,2023,0.0
NCT03127215,,2017-03-31,,,2024-05-07,2017-04-24,2017-04-25,ACTUAL,,,,,,,2024-05-07,2024-05-08,ACTUAL,2018-10-25,ACTUAL,2018-10-25,2023-08,2023-08-31,2023-12-19,ACTUAL,2023-12-19,2023-12-19,ACTUAL,2023-12-19,,INTERVENTIONAL,NCT-PMO-1603,,Study of Olaparib/Trabectedin vs. Doctor's Choice in Solid Tumors,A Randomized Phase-2 Study of Trabectedin/Olaparib Compared to Physician's Choice in Subjects With Previously Treated Advanced or Recurrent Solid Tumors Harboring DNA Repair Deficiencies,COMPLETED,,PHASE2,102.0,ACTUAL,"National Center for Tumor Diseases, Heidelberg",,2.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,OTHER,,,,,,,2023,0.0
NCT01952730,,2013-04-26,2021-09-01,,2022-12-20,2013-09-25,2013-09-30,ESTIMATED,2022-12-20,2023-01-12,ACTUAL,,,,2022-12-20,2023-01-12,ACTUAL,2013-11-08,ACTUAL,2013-11-08,2022-12,2022-12-31,2020-02,ACTUAL,2020-02-29,2018-09,ACTUAL,2018-09-30,,INTERVENTIONAL,,,Pilot Study of GVAX in Colorectal Cancer Cells,"A Pilot Safety Study of Vaccination With Autologous, Lethally Irradiated Colorectal Cancer Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human Granulocyte-Macrophage Stimulating Factor",TERMINATED,,PHASE1,1.0,ACTUAL,Massachusetts General Hospital,,1.0,,Slow Accrual,f,,,,t,,,,,,,,,,,,,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,OTHER,,,,,,,2020,0.0
NCT02990845,,2016-12-01,,,2023-02-20,2016-12-08,2016-12-13,ESTIMATED,,,,,,,2023-02-20,2023-02-22,ACTUAL,2017-09-15,ACTUAL,2017-09-15,2023-02,2023-02-28,2022-08-16,ACTUAL,2022-08-16,2022-08-16,ACTUAL,2022-08-16,,INTERVENTIONAL,PEER,,Pembrolizumab and Exemestane/ Leuprolide in Premenopausal HR+/ HER2- Locally Advanced or Metastatic Breast Cancer,A Pilot Study of Pembrolizumab and Exemestane/ Leuprolide in Premenopausal Hormone Receptor Positive/ HER2 Negative Locally Advanced or Metastatic Breast Cancer,TERMINATED,,PHASE1/PHASE2,16.0,ACTUAL,National Taiwan University Hospital,,1.0,,"The enrolment became difficult, as most of the premenopausal women decided to receive ovarian ablation for health insurance reimbursement for CDK4/6 inhibitor for the first-line treatment, making them ineligible for joining the study.",f,,,,f,f,f,,,,,,,,,,,2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,OTHER,,,,,,,2022,0.0
NCT02991456,,2016-12-09,2023-05-09,,2023-07-10,2016-12-09,2016-12-13,ESTIMATED,2023-07-10,2023-07-11,ACTUAL,,,,2023-07-10,2023-07-11,ACTUAL,2017-10-09,ACTUAL,2017-10-09,2023-07,2023-07-31,2022-06-20,ACTUAL,2022-06-20,2022-05-09,ACTUAL,2022-05-09,,INTERVENTIONAL,,,Rolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide,"Phase II Randomized Study to Evaluate Efficacy, Patient Satisfaction, and Compliance of the Oral Combination of Rolapitant (Varubi®) Plus Ondansetron vs. Ondansetron Monotherapy in Malignant Glioma Patients Receiving Radiotherapy (RT) and Concomitant Temozolomide",COMPLETED,,PHASE2,48.0,ACTUAL,Duke University,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,OTHER,,,,,,,2022,1.0
NCT00777491,,2008-10-21,2019-05-31,,2022-05-23,2008-10-21,2008-10-22,ESTIMATED,2019-08-01,2019-08-21,ACTUAL,,,,2022-05-23,2022-06-15,ACTUAL,2008-12,,2008-12-31,2022-05,2022-05-31,2022-05-20,ACTUAL,2022-05-20,2018-02-18,ACTUAL,2018-02-18,,INTERVENTIONAL,,Eligible patients,Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer That Was Removed by Surgery,A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin Or QD Irradiation Plus Gemcitabine Followed By Selective Bladder Preservation And Gemcitabine/Cisplatin Adjuvant Chemotherapy,COMPLETED,,PHASE2,70.0,ACTUAL,Radiation Therapy Oncology Group,Adverse event data was updated when outcome measure 5 was entered.,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,NETWORK,,,,,,,2022,1.0
NCT05244954,,2022-01-11,,,2022-11-14,2022-02-08,2022-02-17,ACTUAL,,,,,,,2022-11-14,2022-11-15,ACTUAL,2022-02-01,ACTUAL,2022-02-01,2022-11,2022-11-30,2022-08-26,ACTUAL,2022-08-26,2022-08-26,ACTUAL,2022-08-26,,INTERVENTIONAL,,,Comparing Chemoprevention Approaches for School-based Malaria Control,Clinical Trial to Evaluate Intermittent Screening and Treatment and Intermittent Preventive Treatment of Malaria in Asymptomatic Schoolchildren to Decrease P. Falciparum Infection and Transmission,COMPLETED,,PHASE4,746.0,ACTUAL,"University of Maryland, Baltimore",,3.0,,,f,,,,t,f,f,,,f,,,After results publication,Public access with registration to allow tracking,,YES,all individual participant data that underlie results in a publication,2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,OTHER,,,,,,,2022,1.0
NCT03493282,,2018-02-14,2022-07-13,,2023-09-05,2018-04-03,2018-04-10,ACTUAL,2023-02-06,2023-03-01,ACTUAL,,,,2023-09-05,2023-09-07,ACTUAL,2018-03-28,ACTUAL,2018-03-28,2023-09,2023-09-30,2020-10-16,ACTUAL,2020-10-16,2020-10-16,ACTUAL,2020-10-16,,INTERVENTIONAL,,,Effect of CT1812 Treatment on Brain Synaptic Density,A Pilot Synaptic Vesicle Glycoprotein 2A (SV2A) PET Study to Evaluate the Effect of CT1812 Treatment on Synaptic Density in Participants With Mild to Moderate Alzheimer's Disease,COMPLETED,,PHASE1/PHASE2,43.0,ACTUAL,Cognition Therapeutics,,3.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,INDUSTRY,,,,,,,2020,1.0
NCT01974206,,2013-10-28,2021-10-21,2017-05-01,2022-02-16,2013-10-28,2013-11-01,ESTIMATED,2021-12-07,2022-01-04,ACTUAL,2017-05-01,2017-05-02,ACTUAL,2022-02-16,2022-02-17,ACTUAL,2013-11-20,ACTUAL,2013-11-20,2022-02,2022-02-28,2020-11-05,ACTUAL,2020-11-05,2016-05-13,ACTUAL,2016-05-13,,INTERVENTIONAL,,"Randomized population: Age, Gender, Race, Ethnicity Randomized population: Use of ATG, Source of current Transplant, randomization strata","A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor","A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor",COMPLETED,,PHASE2,150.0,ACTUAL,Astellas Pharma Inc,,2.0,,,f,,,,t,t,f,,,,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://www.clinicalstudydatarequest.com/,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,INDUSTRY,,,,,,,2020,1.0
NCT05057273,,2021-08-16,,,2023-06-06,2021-09-16,2021-09-27,ACTUAL,,,,,,,2023-06-06,2023-06-07,ACTUAL,2021-11,ESTIMATED,2021-11-30,2023-06,2023-06-30,2022-02,ESTIMATED,2022-02-28,2022-02,ESTIMATED,2022-02-28,,INTERVENTIONAL,,,Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease,"A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease",WITHDRAWN,,PHASE2,0.0,ACTUAL,NImmune Biopharma,,2.0,,Decision by Landos Biopharma (not related to safety or efficacy),f,,,,,t,f,,,,,,,,,NO,,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,INDUSTRY,,,,,,,2022,0.0
NCT04945616,,2021-06-01,,,2022-06-30,2021-06-22,2021-06-30,ACTUAL,,,,,,,2022-06-30,2022-07-01,ACTUAL,2021-07-13,ACTUAL,2021-07-13,2022-06,2022-06-30,2022-06-15,ACTUAL,2022-06-15,2021-10-19,ACTUAL,2021-10-19,,INTERVENTIONAL,,,"To Evaluate the Safety and Tolerability of Combined Administration of SHR2285 Tablets With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects","Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets Combined With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects",COMPLETED,,PHASE1,52.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,3.0,,,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,INDUSTRY,,,,,,,2022,1.0
NCT05319756,,2022-03-08,2023-04-17,,2023-07-21,2022-03-31,2022-04-08,ACTUAL,2023-07-21,2023-08-14,ACTUAL,,,,2023-07-21,2023-08-14,ACTUAL,2021-04-30,ACTUAL,2021-04-30,2023-07,2023-07-31,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,The randomized population included all participants who were randomized to a treatment sequence in the Treatment Phase.,"Study Evaluating the Abuse Potential of NEURONTIN® in Healthy Non-drug Dependent, Recreational Opioid Users",A Phase 4 Randomized Double-blind Double-dummy Placebo & Active-controlled Single-dose Six-way Crossover Study Evaluating Abuse Potential of NEURONTIN® Taken Orally With Oxycodone HCL in Healthy Non-drug Dependent Recreational Opioid Users,COMPLETED,,PHASE4,54.0,ACTUAL,Viatris Inc.,,6.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,INDUSTRY,,,,,,,2021,1.0
NCT03068949,,2017-02-23,2021-06-29,,2021-11-01,2017-02-27,2017-03-03,ACTUAL,2021-11-01,2021-11-30,ACTUAL,,,,2021-11-01,2021-11-30,ACTUAL,2015-10-28,ACTUAL,2015-10-28,2021-11,2021-11-30,2021-06-30,ACTUAL,2021-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,Comparison of Three Licensed Influenza Vaccines,A Comparison of CD4 T Cell Induction and Antibody Responses Between a Pure Hemagglutinin Influenza Vaccine and Licensed Subvirion Influenza Vaccine Made in Eggs or Cell Culture in Healthy Adults.,COMPLETED,,PHASE4,413.0,ACTUAL,University of Rochester,,4.0,,,f,,,,f,t,f,,,f,,,12 months,Broad Access,,YES,Data will be shared with the CEIRS (Centers of Excellence for Influenza Research and Surveillance) network,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,OTHER,,,,,,,2021,1.0
NCT03710941,,2018-10-15,,,2019-04-25,2018-10-15,2018-10-18,ACTUAL,,,,,,,2019-04-25,2019-04-29,ACTUAL,2019-02-19,ESTIMATED,2019-02-19,2019-04,2019-04-30,2020-11-05,ESTIMATED,2020-11-05,2020-08-27,ESTIMATED,2020-08-27,,INTERVENTIONAL,,,Safety and Efficacy of REGN2477+REGN1033 in Patients With Sporadic Inclusion Body Myositis,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenously Administered REGN2477+REGN1033 in Patients With Sporadic Inclusion Body Myositis",WITHDRAWN,,PHASE2,0.0,ACTUAL,Regeneron Pharmaceuticals,,2.0,,The study was withdrawn due to an internal decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 07:49:42.562412,2024-10-16 07:49:42.562412,INDUSTRY,,,,,,,2020,0.0
NCT03928821,,2019-04-23,2022-03-14,,2022-06-15,2019-04-23,2019-04-26,ACTUAL,2022-06-15,2022-07-11,ACTUAL,,,,2022-06-15,2022-07-11,ACTUAL,2019-07-17,ACTUAL,2019-07-17,2022-06,2022-06-30,2021-03-25,ACTUAL,2021-03-25,2021-03-25,ACTUAL,2021-03-25,,INTERVENTIONAL,,,"Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult Participants","A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult Participants",COMPLETED,,PHASE1,27.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,NIH,,,,,,,2021,1.0
NCT02594267,,2015-09-25,,,2021-07-23,2015-10-30,2015-11-03,ESTIMATED,,,,,,,2021-07-23,2021-07-27,ACTUAL,2015-11-10,ACTUAL,2015-11-10,2021-07,2021-07-31,2020-10-08,ACTUAL,2020-10-08,2017-04-07,ACTUAL,2017-04-07,,INTERVENTIONAL,,,A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL),"A Phase 1, Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With Peripheral T-Cell Lymphoma (PTCL)",COMPLETED,,PHASE1,48.0,ACTUAL,Acrotech Biopharma Inc.,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,INDUSTRY,,,,,,,2020,1.0
NCT04127695,,2019-10-09,,,2021-12-13,2019-10-14,2019-10-15,ACTUAL,,,,,,,2021-12-13,2021-12-15,ACTUAL,2020-03-03,ACTUAL,2020-03-03,2021-12,2021-12-31,2020-06-16,ACTUAL,2020-06-16,2020-06-16,ACTUAL,2020-06-16,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Tolerability of ABBV-0805 in Patients With Parkinson's Disease,"A Randomized, Double-Blind, Placebo Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of ABBV-0805 in Patients With Parkinson's Disease",WITHDRAWN,,PHASE1,0.0,ACTUAL,AbbVie,,4.0,,Strategic considerations,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,INDUSTRY,,,,,,,2020,0.0
NCT00979212,,2009-09-16,2016-06-30,,2022-05-23,2009-09-16,2009-09-17,ESTIMATED,2016-06-30,2016-08-16,ESTIMATED,,,,2022-05-23,2022-06-15,ACTUAL,2011-02,,2011-02-28,2022-05,2022-05-31,2022-05-20,ACTUAL,2022-05-20,2015-12,ACTUAL,2015-12-31,,INTERVENTIONAL,,All eligible patients receiving protocol treatment,Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer,"Randomized Phase II Study of Pre-operative Chemoradiotherapy +/- Panitumumab (IND #110152) Followed by Consolidation Chemotherapy in Potentially Operable Locally Advanced (Stage IIIA, N2+) Non-Small Cell Lung Cancer",COMPLETED,,PHASE2,71.0,ACTUAL,Radiation Therapy Oncology Group,"Following a recommendation on July 13, 2015 by the NRG Data Monitoring Committee accrual was halted early after accruing only 71 of 97 patients due to unexpectedly high rates of grade 5 toxicity on the panitumumab arm.",2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,NETWORK,,,,,,,2022,1.0
NCT04891497,,2021-05-17,,,2023-10-24,2021-05-17,2021-05-18,ACTUAL,,,,,,,2023-10-24,2023-10-25,ACTUAL,2021-06-01,ESTIMATED,2021-06-01,2021-05,2021-05-31,2021-12-31,ESTIMATED,2021-12-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment in Acute Ischemic Stroke,Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment in Acute Ischemic Stroke,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Xuanwu Hospital, Beijing",,2.0,,There are no suitable patients,f,,,,,f,f,,,,,,,,,,,2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,OTHER,,,,,,,2021,0.0
NCT04705727,,2021-01-04,,,2023-07-24,2021-01-11,2021-01-12,ACTUAL,,,,,,,2023-07-24,2023-07-27,ACTUAL,2021-08-23,ACTUAL,2021-08-23,2023-07,2023-07-31,2023-06-23,ACTUAL,2023-06-23,2021-09-23,ACTUAL,2021-09-23,,INTERVENTIONAL,ASTHMAFAST,,Budesonide/Formoterol Turbuhaler® Versus Terbutaline Nebulization as Reliever Therapy in Children With Moderate Asthma Exacerbation,Comparison of the Efficacy and Safety of Budesonide/Formoterol Turbuhaler® Versus Terbutaline Nebulization as Reliever Therapy in Children With Asthma Presenting at the Emergency Room for Moderate Exacerbation,TERMINATED,,PHASE3,102.0,ACTUAL,Centre Hospitalier Intercommunal Creteil,,2.0,,Not enough recruitment in th trial,f,,,,t,f,f,,,,,,,,,,,2024-10-16 07:56:06.936978,2024-10-16 07:56:06.936978,OTHER,,,,,,,2023,0.0
NCT03440437,,2018-02-08,,,2024-08-05,2018-02-14,2018-02-22,ACTUAL,,,,,,,2024-08-05,2024-08-07,ACTUAL,2018-04-16,ACTUAL,2018-04-16,2024-07,2024-07-31,2024-06-21,ACTUAL,2024-06-21,2024-06-21,ACTUAL,2024-06-21,,INTERVENTIONAL,,,A Phase 1/2 Study of FS118 in Patients With Advanced Malignancies,"A Phase 1/2, Open-Label, Study to Evaluate the Safety and Anti-Tumor Activity of FS118, a LAG-3/PD-L1 Bispecific Antibody, as a Monotherapy and in Combination With Paclitaxel, in Patients With Advanced Malignancies",TERMINATED,,PHASE1/PHASE2,80.0,ACTUAL,invoX Pharma Limited,,1.0,,Business Decision,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 07:56:06.936978,2024-10-16 07:56:06.936978,INDUSTRY,,,,,,,2024,0.0
NCT02498535,,2015-07-12,,,2021-03-03,2015-07-12,2015-07-15,ESTIMATED,,,,,,,2021-03-03,2021-03-05,ACTUAL,2017-02-22,ACTUAL,2017-02-22,2021-03,2021-03-31,2020-06-01,ACTUAL,2020-06-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,,,Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) Patients,"Prospective, Randomized, Placebo Controlled Trial of the Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) Patients",TERMINATED,,PHASE2,49.0,ACTUAL,"Novoteris, LLC",,2.0,,Terminated for the safety of cystic fibrosis clinical trial subjects due to Covid-19.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,INDUSTRY,,,,,,,2020,0.0
NCT03060356,,2017-02-07,,,2023-06-20,2017-02-17,2017-02-23,ACTUAL,,,,,,,2023-06-20,2023-06-22,ACTUAL,2016-12-21,ACTUAL,2016-12-21,2023-06,2023-06-30,2020-03-27,ACTUAL,2020-03-27,2020-03-27,ACTUAL,2020-03-27,,INTERVENTIONAL,,,Autologous T Cells Expressing MET scFv CAR (RNA CART-cMET),Clinical Trial of Autologous cMET Redirected T Cells Administered Intravenously in Patients With Melanoma & Breast Carcinoma,TERMINATED,,EARLY_PHASE1,77.0,ACTUAL,University of Pennsylvania,,2.0,,Halt in funding,,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-15 21:27:11.792594,2024-10-15 21:27:11.792594,OTHER,,,,,,,2020,0.0
NCT04175392,,2019-11-21,2022-07-27,,2022-08-30,2019-11-21,2019-11-25,ACTUAL,2022-08-30,2022-09-27,ACTUAL,,,,2022-08-30,2022-09-27,ACTUAL,2021-01-12,ACTUAL,2021-01-12,2022-08,2022-08-31,2022-03-01,ACTUAL,2022-03-01,2022-03-01,ACTUAL,2022-03-01,,INTERVENTIONAL,PRONE,,Effect of Probiotics in Non-alcoholic Fatty Liver Disease and Steatohepatitis,Effect of Probiotics in Non-Alcoholic Fatty Liver Disease and Steatohepatitis Measured by Transient Elastography (PRONE Study).,TERMINATED,,PHASE1/PHASE2,14.0,ACTUAL,William Beaumont Hospitals,,2.0,,lack of enrollment,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,OTHER,,,,,,,2022,0.0
NCT03660059,,2018-08-26,,,2024-04-21,2018-09-04,2018-09-06,ACTUAL,,,,,,,2024-04-21,2024-04-23,ACTUAL,2018-09-27,ACTUAL,2018-09-27,2024-04,2024-04-30,2021-11-02,ACTUAL,2021-11-02,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,,,A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX),"A Randomized, Double-Blind, Placebo-Controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to MTX",COMPLETED,,PHASE3,385.0,ACTUAL,Astellas Pharma Inc,,3.0,,,f,,,,f,f,f,,,,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://www.clinicalstudydatarequest.com,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,INDUSTRY,,,,,,,2021,1.0
NCT02004691,,2013-11-26,2022-04-27,2020-10-13,2023-11-30,2013-12-04,2013-12-09,ESTIMATED,2022-04-27,2022-05-24,ACTUAL,2020-10-13,2020-10-19,ACTUAL,2023-11-30,2023-12-04,ACTUAL,2015-12-18,ACTUAL,2015-12-18,2023-11,2023-11-30,2023-10-19,ACTUAL,2023-10-19,2021-03-15,ACTUAL,2021-03-15,,INTERVENTIONAL,ASCEND,Analysis was performed on modified intent-to-treat (mITT) population which included all randomized participants who had received at least 1 infusion (partial or total) and were analyzed according to the treatment arm allocated by randomization.,"Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency","A Phase 2/3, Multicenter, Randomized, Double-blinded, Placebo-controlled, Repeat-dose Study to Evaluate the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency",COMPLETED,,PHASE2/PHASE3,36.0,ACTUAL,Sanofi,,2.0,,,t,,,,t,t,,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.",2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,INDUSTRY,,NCT04877132,APPROVED_FOR_MARKETING,,,,2023,1.0
NCT05428215,,2022-01-11,,,2023-07-24,2022-06-17,2022-06-23,ACTUAL,,,,,,,2023-07-24,2023-07-27,ACTUAL,2022-12-29,ACTUAL,2022-12-29,2023-07,2023-07-31,2023-07-20,ACTUAL,2023-07-20,2023-07-20,ACTUAL,2023-07-20,,INTERVENTIONAL,,,Comparison of PKs of 17-Beta-Estradiol Via Sublingual Placement Versus Swallowing in Male-to-Female Transgender Patients,Comparison of Pharmacokinetics of 17-Beta-Estradiol Via Oral Administration With Sublingual Placement Versus Oral Administration With Swallowing of 17-Beta-estradiol in Male-to-Female Transgender Patients,TERMINATED,,PHASE4,2.0,ACTUAL,MaineHealth,,2.0,,"Inability to adequately recruit participants, need for additional study participants based on preliminary data collection",f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,OTHER,,,,,,,2023,0.0
NCT03785756,,2018-12-17,2022-05-12,,2024-05-31,2018-12-20,2018-12-24,ACTUAL,2024-05-31,2024-06-03,ACTUAL,,,,2024-05-31,2024-06-03,ACTUAL,2019-04-29,ACTUAL,2019-04-29,2024-05,2024-05-31,2020-02-28,ACTUAL,2020-02-28,2020-02-20,ACTUAL,2020-02-20,,INTERVENTIONAL,,One subject in the placebo group withdrew from the study before receiving the allocation intervention.,Efficacy of 300 mg Ibuprofen Prolonged-Release Tablets for the Treatment of Pain After Surgical Removal of Impacted Third Molars,"A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Multiple-Dose, Active and Placebo-Controlled Efficacy Study of Ibuprofen Prolonged-Release Tablets for the Treatment of Pain After Surgical Removal of Impacted Third Molars",COMPLETED,,PHASE3,280.0,ACTUAL,Reckitt Benckiser Healthcare (UK) Limited,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,INDUSTRY,,,,,,,2020,1.0
NCT04464148,,2020-07-03,,,2021-08-19,2020-07-03,2020-07-09,ACTUAL,,,,,,,2021-08-19,2021-08-23,ACTUAL,2021-12,ESTIMATED,2021-12-31,2021-08,2021-08-31,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Feasibility Trial of Pregnenolone for Posttraumatic Stress Disorder and Alcohol Use Disorder,Feasibility Trial of Pregnenolone for Posttraumatic Stress Disorder and Alcohol Use Disorder,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Texas Southwestern Medical Center,,1.0,,Feasibility study was not initiated.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,OTHER,,,,,,,2021,0.0
NCT04131517,,2019-10-16,2021-05-20,,2021-06-22,2019-10-16,2019-10-18,ACTUAL,2021-06-22,2021-06-24,ACTUAL,,,,2021-06-22,2021-06-24,ACTUAL,2019-10-23,ACTUAL,2019-10-23,2021-06,2021-06-30,2020-05-22,ACTUAL,2020-05-22,2020-05-22,ACTUAL,2020-05-22,,INTERVENTIONAL,,"Baseline Characteristics refer to Safety Set which included study participants who received at least 1 dose of study medication (PSL or OC). No study participants started Part 2 due to the COVID-19 pandemic. Later, the program developing PSL in focal-onset seizures was stopped and the study was terminated.",A Study to Test the Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants,"An Open-Label, Randomized, Two-Way Crossover Study to Investigate the Potential Pharmacokinetic Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants",TERMINATED,,PHASE1,14.0,ACTUAL,UCB Pharma,The study was terminated on 22 May 2020 because the program developing padsevonil in focal-onset seizures was stopped.,2.0,,"Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures",f,,,,f,t,f,,,,,,,,,NO,"Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.",2024-10-16 07:56:06.936978,2024-10-16 07:56:06.936978,INDUSTRY,,,,,,,2020,0.0
NCT03553563,,2018-04-05,,,2023-04-11,2018-05-30,2018-06-12,ACTUAL,,,,,,,2023-04-11,2023-04-12,ACTUAL,2018-07-24,ACTUAL,2018-07-24,2023-04,2023-04-30,2022-12-27,ACTUAL,2022-12-27,2022-12-27,ACTUAL,2022-12-27,,INTERVENTIONAL,,,"A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer","An Open Label, Parallel Group, Multi-centre, Phase III Study to Assess the Efficacy and Safety of D961H for the Maintenance Therapy Following Initial Treatment in Japanese Paediatric Patients With Reflux Esophagitis and for the Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer in Japanese Paediatric Patients Treated With Non-steroidal Anti-inflammatory Drugs or Low-dose Aspirin",COMPLETED,,PHASE3,51.0,ACTUAL,AstraZeneca,,4.0,,,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,INDUSTRY,,,,,,,2022,1.0
NCT03444298,,2018-01-31,2024-01-05,,2024-02-01,2018-02-21,2018-02-23,ACTUAL,2024-02-01,2024-02-05,ACTUAL,,,,2024-02-01,2024-02-05,ACTUAL,2018-06-08,ACTUAL,2018-06-08,2024-01,2024-01-31,2023-03-06,ACTUAL,2023-03-06,2023-03-02,ACTUAL,2023-03-02,,INTERVENTIONAL,SmokeyT,,A Study of Gamma Tocopherol-enriched Supplement on Lower Airway Responses to Inhaled Wood Smoke in Healthy Adults,"A Phase II Randomized, Double Blinded, Placebo-controlled Study of Gamma Tocopherol-enriched Supplement on Lower Airway Responses to Inhaled Wood Smoke in Healthy Adults",COMPLETED,,PHASE2,16.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,OTHER,,,,,,,2023,1.0
NCT02618109,,2015-04-15,,,2022-09-29,2015-11-26,2015-12-01,ESTIMATED,,,,,,,2022-09-29,2022-10-03,ACTUAL,2016-01,ACTUAL,2016-01-31,2022-09,2022-09-30,2022-09,ACTUAL,2022-09-30,2022-09,ACTUAL,2022-09-30,,INTERVENTIONAL,LABMI,,Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia,Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia,TERMINATED,,PHASE4,119.0,ACTUAL,"University Hospital, Angers",,2.0,,recruitment difficulties,f,,,,f,,,,,,,,,,,,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,OTHER_GOV,,,,,,,2022,0.0
NCT01906073,,2013-07-19,,,2020-12-08,2013-07-19,2013-07-23,ESTIMATED,,,,,,,2020-12-08,2020-12-10,ACTUAL,2017-01,ACTUAL,2017-01-31,2020-12,2020-12-31,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,NFCP-2,,Nasal Fentanyl for Chronic Cancer Pain,"An Open Label, Cross-over, Randomized Controlled Multicenter Phase III Study Comparing Standard Oral SR-morphine by the Clock Medications With Self-controlled Nasal Fentanyl for Chronic Cancer Pain Requiring Opioids",WITHDRAWN,,PHASE3,0.0,ACTUAL,Norwegian University of Science and Technology,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,OTHER,,,,,,,2020,0.0
NCT04995497,,2021-08-02,2024-08-13,,2024-08-13,2021-08-02,2021-08-09,ACTUAL,2024-08-13,2024-09-04,ACTUAL,,,,2024-08-13,2024-09-04,ACTUAL,2021-08-15,ACTUAL,2021-08-15,2024-08,2024-08-31,2023-04-30,ACTUAL,2023-04-30,2023-04-07,ACTUAL,2023-04-07,,INTERVENTIONAL,,Its the same,Intravenous(IV) vs. Erector Spinae Plane Blocks in Cardiac Surgery,IV vs. Erector Spinae Plane Blocks-Cardiac Surgery,COMPLETED,,PHASE2,70.0,ACTUAL,University of Iowa,Ours is a single center trial. This likely should be investigated at multiple institutions with different surgical anesthesia groups for proper validation.,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,OTHER,,,,,,,2023,1.0
NCT05264506,,2022-01-28,,,2024-02-06,2022-03-02,2022-03-03,ACTUAL,,,,,,,2024-02-06,2024-02-08,ACTUAL,2022-02-17,ACTUAL,2022-02-17,2024-02,2024-02-29,2024-01-26,ACTUAL,2024-01-26,2024-01-12,ACTUAL,2024-01-12,,INTERVENTIONAL,,,Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive,"A Phase 3, Open-label, Multi-center, Single-arm Study to Assess Contraceptive Efficacy and Safety of the Nomegestrol Acetate + 17β-estradiol Combined Oral Contraceptive (OG-8175A) in Premenopausal Females Aged 14 to 35 Years (Inclusive)",TERMINATED,,PHASE3,2007.0,ACTUAL,Organon and Co,,1.0,,Sponsor decision to stop the study early and complete all required study close-out activities. This decision was made for business reasons unrelated to safety. None of the pre-specified efficacy endpoints were analyzed.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,INDUSTRY,,,,,,,2024,0.0
NCT04184609,,2019-11-29,,,2023-11-03,2019-11-29,2019-12-03,ACTUAL,,,,,,,2023-11-03,2023-11-07,ACTUAL,2023-07-01,ESTIMATED,2023-07-01,2023-11,2023-11-30,2023-11-03,ESTIMATED,2023-11-03,2023-11-03,ACTUAL,2023-11-03,,INTERVENTIONAL,,,Mechanisms for Dyspnea on Exertion in Children With Obesity and Asthma: Distinct Physiological Phenotypes,Mechanisms for Dyspnea on Exertion in Children With Obesity and Asthma: Distinct Physiological Phenotypes,WITHDRAWN,,PHASE4,0.0,ACTUAL,Ohio State University,,1.0,,Funding ran out before participants were enrolled.,f,,,,t,t,f,,,f,,,,,,NO,There is no plan to share all of the individual participant data collected during the trial.,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,OTHER,,,,,,,2023,0.0
NCT03769090,,2018-11-30,2022-07-29,,2022-09-01,2018-12-06,2018-12-07,ACTUAL,2022-09-01,2022-09-28,ACTUAL,,,,2022-09-01,2022-09-28,ACTUAL,2018-12-13,ACTUAL,2018-12-13,2022-09,2022-09-30,2022-02-07,ACTUAL,2022-02-07,2021-08-19,ACTUAL,2021-08-19,,INTERVENTIONAL,MANDALA,"Of the 3,132 participants randomized, the full analysis set across all ages comprises 3,127 participants as one participant was randomized and did not receive randomized study treatment, and four participants were randomized in error and did not receive randomized study treatment. These five participants have therefore been excluded from the summaries of baseline characteristics, efficacy and safety.",A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma,"A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older With Asthma",COMPLETED,,PHASE3,3132.0,ACTUAL,Bond Avillion 2 Development LP,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,INDUSTRY,,,,,,,2022,1.0
NCT03152409,,2017-04-13,2023-12-08,,2024-01-04,2017-05-11,2017-05-15,ACTUAL,2024-01-04,2024-01-31,ACTUAL,,,,2024-01-04,2024-01-31,ACTUAL,2018-11-15,ACTUAL,2018-11-15,2024-01,2024-01-31,2021-02-16,ACTUAL,2021-02-16,2021-02-16,ACTUAL,2021-02-16,,INTERVENTIONAL,SAD,,Salicylic Augmentation in Depression,Salicylic Augmentation in Depression,TERMINATED,,PHASE2,32.0,ACTUAL,Brigham and Women's Hospital,"In Mar. 2020 study placed on prolonged pause due to the pandemic. Research activities resumed with limitations later that year. The last study participant was screened in Feb. 2021. However, personnel departure affected study activities, so study was again paused, with plans to resume once adequate personnel were hired. However no additional support was provided. In Dec. 2022, it was decided to terminate the study when it became clear that resources would be insufficient to complete the trial.",2.0,,Inadequate resources to complete the study,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,OTHER,,,,,,,2021,0.0
NCT04715230,,2021-01-13,2023-10-02,,2023-10-30,2021-01-14,2021-01-20,ACTUAL,2023-10-30,2023-11-18,ACTUAL,,,,2023-10-30,2023-11-18,ACTUAL,2021-06-30,ACTUAL,2021-06-30,2023-01,2023-01-31,2022-11-14,ACTUAL,2022-11-14,2022-10-05,ACTUAL,2022-10-05,,INTERVENTIONAL,Meth-OD,,Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose,Meth-OD: A Phase 2a Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose,TERMINATED,,PHASE2,20.0,ACTUAL,"InterveXion Therapeutics, LLC",Early termination leading to small numbers of subjects analyzed.,2.0,,Sponsor decision based on slower than anticipated enrollment leading to fund exhaustion.,f,,,,t,t,f,,,,,,These datasets will be available for distribution following submission to the FDA of the Clinical Study Report and publication. They will be available for 2 years after the initial publication.,These datasets and associated documentation will be made available on CD by the Sponsor to requestors under a data sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology and not distributing to third parties; and (3) a commitment to destroying or returning the data after analyses are completed. Requests should be sent to intervexion@gmail.com,,YES,"Final datasets are expected to contain IXT-m200 and METH concentration data, ACES scores over time, and safety data. No individually identifiable private information will be distributes.",2024-10-16 07:56:06.936978,2024-10-16 07:56:06.936978,INDUSTRY,,,,,,,2022,0.0
NCT04351230,,2020-04-15,,,2022-05-25,2020-04-15,2020-04-17,ACTUAL,,,,,,,2022-05-25,2022-05-26,ACTUAL,2020-11-11,ACTUAL,2020-11-11,2022-02,2022-02-28,2022-02-16,ACTUAL,2022-02-16,2022-02-16,ACTUAL,2022-02-16,,INTERVENTIONAL,,,T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer,"Phase II Trial of Abemaciclib and T-DM1 in Women and Men With HER2-positive Advanced or Metastatic Breast Cancer Who Progressed on Treatment With a Taxane, Trastuzumab and Pertuzumab",WITHDRAWN,,PHASE2,0.0,ACTUAL,Academic and Community Cancer Research United,,2.0,,There are no patients enrolled on this study and all efforts are being discontinued,,,,,t,t,f,,,f,,,,,,,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,OTHER,,,,,,,2022,0.0
NCT02683213,,2016-02-02,,,2020-09-01,2016-02-16,2016-02-17,ESTIMATED,,,,,,,2020-09-01,2020-09-02,ACTUAL,2014-10-20,ACTUAL,2014-10-20,2020-09,2020-09-30,2020-06,ACTUAL,2020-06-30,2020-06,ACTUAL,2020-06-30,,INTERVENTIONAL,EFFECTS,,Efficacy of Fluoxetine - a Trial in Stroke,Establishing the Effect(s) and Safety of Fluoxetine Initiated in the Acute Phase of Stroke,COMPLETED,,PHASE3,1500.0,ACTUAL,Karolinska Institutet,,2.0,,,f,,,,t,,,,,,,,,,,YES,"Three trial investigator teams have collaboratively developed a core protocol for Fluoxetine after stroke. Minor variations have been tailored to the national setting in the UK (FOCUS), Australia and New Zealand (AFFINITY) and Sweden (EFFECTS). Each trial is run and funded independently and will report its own results. A prospectively planned individual patient data meta-analysis of all three trials will subsequently provide the most precise estimate of the overall effect of fluoxetine after stroke and establish whether any effects differ between trials and subgroups of patients.",2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,OTHER,,,,,,,2020,0.0
NCT04225897,,2019-12-11,,,2023-06-23,2020-01-08,2020-01-13,ACTUAL,,,,,,,2023-06-23,2023-06-26,ACTUAL,2019-11-13,ACTUAL,2019-11-13,2023-06,2023-06-30,2022-12-05,ACTUAL,2022-12-05,2022-12-05,ACTUAL,2022-12-05,,INTERVENTIONAL,REVIRAL 1,,A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.,"A Phase 2 Open-Label Study in Infants With REspiratory Syncytial VIRus Lower RespirAtory Tract Infection, Followed by a DoubLe-blind, Placebocontrolled Part, to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of RV521 (REVIRAL 1)",TERMINATED,,PHASE2,51.0,ACTUAL,Pfizer,,2.0,,Part A and Part B were completed but Pfizer terminated Part C due to strategic consideration. There were no safety concerns in the decision to stop Part C and no changes to the risk-benefit for participants who received RV521 in the study.,f,,,,t,f,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,INDUSTRY,,,,,,,2022,0.0
NCT04854096,,2021-04-09,,,2024-06-04,2021-04-20,2021-04-22,ACTUAL,,,,,,,2024-06-04,2024-06-06,ACTUAL,2023-01-31,ACTUAL,2023-01-31,2024-06,2024-06-30,2024-05-16,ACTUAL,2024-05-16,2024-05-16,ACTUAL,2024-05-16,,INTERVENTIONAL,,,Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis,"A Phase 2b, Open-label, Multicenter, Randomized, Controlled, 2-Arm Study to Assess the Efficacy and Safety of Orally Administered NS-018 Versus Best Available Therapy in Subjects With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Severe Thrombocytopenia (Platelet Count <50,000/μL)",TERMINATED,,PHASE2,7.0,ACTUAL,"NS Pharma, Inc.",,2.0,,The study was stopped due to a business decision.,,,,,t,t,f,,,,,,,,,NO,Submission to the FDA,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,INDUSTRY,,,,,,,2024,0.0
NCT03696342,,2018-10-03,2021-03-30,,2021-08-02,2018-10-03,2018-10-04,ACTUAL,2021-08-02,2021-08-24,ACTUAL,,,,2021-08-02,2021-08-24,ACTUAL,2018-10-01,ACTUAL,2018-10-01,2021-03,2021-03-31,2020-03-24,ACTUAL,2020-03-24,2020-03-24,ACTUAL,2020-03-24,,INTERVENTIONAL,PRO-157,,"Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%.","Clinical Study of the Efficacy of the Ophthalmic Solution of Pazufloxacin 0.6% (PRO-157) for the Treatment of Acute Bacterial Conjunctivitis, Compared to the Ophthalmic Solution of Gatifloxacin 0.3%.",TERMINATED,,PHASE3,46.0,ACTUAL,Laboratorios Sophia S.A de C.V.,This trial was terminated early due to the sponsor's convenience in the pipeline followed by the studied product. A small sample renders this results as merely descriptive.,2.0,,Sponsor's convenience,f,,,,t,f,f,,,,,,,,,,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,INDUSTRY,,,,,,,2020,0.0
NCT02410772,,2015-02-08,2021-07-30,,2021-09-01,2015-04-02,2015-04-08,ESTIMATED,2021-09-01,2021-09-28,ACTUAL,,,,2021-09-01,2021-09-28,ACTUAL,2016-01-25,ACTUAL,2016-01-25,2021-07,2021-07-31,2021-05,ACTUAL,2021-05-31,2020-07,ACTUAL,2020-07-31,,INTERVENTIONAL,S31/A5349,"Baseline Population Description: The population is the Microbiologically eligible population that included the randomized participants excluding the ones with no evidence of cultures positive for M. tuberculosis, or with resistance to one or more of isoniazid, rifampin or fluoroquinolones, or are enrolled in violation of eligibility criteria",TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens,"Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial. TBTC Study 31, ACTG Study A5349",COMPLETED,,PHASE3,2516.0,ACTUAL,Centers for Disease Control and Prevention,"A study limitation is that placebos were not used, and therefore neither participants nor site staff were blinded to treatment assignment. Another limitation is that only 8% of participants were HIV-coinfected, limiting the power to compare regimens in this important population",3.0,,,f,,,,t,t,f,,,,,,,,,YES,Data being collected in CDISC format.,2024-10-16 07:56:06.936978,2024-10-16 07:56:06.936978,FED,,,,,,,2021,1.0
NCT03059147,,2017-02-10,,,2022-05-11,2017-02-16,2017-02-23,ACTUAL,,,,,,,2022-05-11,2022-05-18,ACTUAL,2017-03-27,ACTUAL,2017-03-27,2022-05,2022-05-31,2020-06-29,ACTUAL,2020-06-29,2019-04-22,ACTUAL,2019-04-22,,INTERVENTIONAL,,,Phase 1 Study of SF1126 in Combination With Nivolumab in Patients With Advanced Hepatocellular Carcinoma,"A Phase I Study of SF1126, a Dual PI3 Kinase and Bromodomain Inhibitor, in Combination With Nivolumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma and Child-Pugh A-B7 Cirrhosis",TERMINATED,,PHASE1,7.0,ACTUAL,"SignalRX Pharmaceuticals, Inc.",,1.0,,Lack of recruitment and sponsor's priority changes,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,INDUSTRY,,,,,,,2020,0.0
NCT05053035,,2021-09-01,,,2023-06-14,2021-09-13,2021-09-22,ACTUAL,,,,,,,2023-06-14,2023-06-18,ACTUAL,2021-09-02,ACTUAL,2021-09-02,2023-06,2023-06-30,2022-10-28,ACTUAL,2022-10-28,2022-10-28,ACTUAL,2022-10-28,,INTERVENTIONAL,,,A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALS,"A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in C9orf72-Associated Amyotrophic Lateral Sclerosis",TERMINATED,,PHASE2,5.0,ACTUAL,Alector Inc.,,2.0,,"The Sponsor is considering a subsequent study in ALS, potentially with different inclusion/exclusion criteria.",f,,,,t,t,f,,,,,,,,,,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,INDUSTRY,,,,,,,2022,0.0
NCT03622593,,2018-08-01,2022-02-23,2021-09-01,2024-05-10,2018-08-07,2018-08-09,ACTUAL,2022-02-23,2022-03-22,ACTUAL,2021-09-01,2021-09-09,ACTUAL,2024-05-10,2024-06-04,ACTUAL,2018-10-09,ACTUAL,2018-10-09,2024-05,2024-05-31,2023-05-31,ACTUAL,2023-05-31,2020-10-19,ACTUAL,2020-10-19,,INTERVENTIONAL,RHINE,"The overall number of baseline participants (951) comprises the Intent-to-Treat (ITT) Population, which includes all global participants who were randomized in the study, grouped according to the treatment assigned at randomization.",A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema,"A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)",COMPLETED,,PHASE3,951.0,ACTUAL,Hoffmann-La Roche,"All secondary outcome measures were unpowered for statistical analysis, and the results should be interpreted with caution.",3.0,,,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).~For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 07:56:06.936978,2024-10-16 07:56:06.936978,INDUSTRY,,,,,,,2023,1.0
NCT02021526,,2013-12-12,,,2019-02-12,2013-12-19,2013-12-27,ESTIMATED,,,,,,,2019-02-12,2019-02-15,ACTUAL,2015-12,,2015-12-31,2019-02,2019-02-28,2020-06,ESTIMATED,2020-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,"Triheptanoin (C7 Oil), a Food Supplement, for Glucose Transporter Type I Deficiency (G1D)",Treatment Development of Triheptanoin for Glucose Transporter Type I Deficiency,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,NIH funding resulted in new clinical trial,f,,,,t,,,,,,,,,,,,,2024-10-16 07:56:06.936978,2024-10-16 07:56:06.936978,OTHER,,,,,,,2020,0.0
NCT03037736,,2017-01-27,,,2021-08-05,2017-01-27,2017-01-31,ESTIMATED,,,,,,,2021-08-05,2021-08-12,ACTUAL,2020-03-01,ACTUAL,2020-03-01,2021-08,2021-08-31,2020-03-01,ACTUAL,2020-03-01,2020-03-01,ACTUAL,2020-03-01,,INTERVENTIONAL,OPPS,,Outpatient Performed Pterygium Surgery Study,Outpatient Performed Pterygium Surgery Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of California, San Francisco",,3.0,,Funding not received.,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,OTHER,,,,,,,2020,0.0
NCT05177029,,2021-12-15,,,2022-07-08,2021-12-15,2022-01-04,ACTUAL,,,,,,,2022-07-08,2022-07-12,ACTUAL,2021-11-26,ACTUAL,2021-11-26,2022-07,2022-07-31,2021-12-29,ACTUAL,2021-12-29,2021-12-29,ACTUAL,2021-12-29,,INTERVENTIONAL,,,Safety and Tolerability Study of Lu AG06466 in Healthy Young Japanese and Caucasian Participants,"Interventional, Randomized, Double-Blind, Sequential-Part, Placebo-Controlled, Single- and Multiple-Dose Study Investigating Safety, Tolerability, and Pharmacokinetic Properties of Lu AG06466 in Healthy Young Japanese and Caucasian Subjects",TERMINATED,,PHASE1,24.0,ACTUAL,H. Lundbeck A/S,,2.0,,The study was terminated for strategic reasons.,f,,,,,f,f,,,,,,,,,,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,INDUSTRY,,,,,,,2021,0.0
NCT04364035,,2020-03-05,,,2023-07-26,2020-04-24,2020-04-27,ACTUAL,,,,,,,2023-07-26,2023-07-27,ACTUAL,2020-02-20,ACTUAL,2020-02-20,2023-07,2023-07-31,2022-12-16,ACTUAL,2022-12-16,2022-10-03,ACTUAL,2022-10-03,,INTERVENTIONAL,AELIX-003,,"Safety, Tolerability and Immunogenicity of MVA.HTI and ChAdOx1.HTI With Vesatolimod in HIV-1 Positive Patients","A Phase IIa Randomised, Double-blind, Placebo-controlled Study of HIV-1 Vaccines MVA.HTI and ChAdOx1.HTI With TLR7 Agonist Vesatolimod (GS-9620) in Early Treated HIV-1 Infection",COMPLETED,,PHASE2,50.0,ACTUAL,Aelix Therapeutics,,2.0,,,,,,,t,t,f,,,t,,,,,,,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,INDUSTRY,,,,,,,2022,1.0
NCT04451720,,2020-06-29,,,2022-12-02,2020-06-29,2020-06-30,ACTUAL,,,,,,,2022-12-02,2022-12-05,ACTUAL,2020-07-20,ACTUAL,2020-07-20,2022-12,2022-12-31,2022-11-21,ACTUAL,2022-11-21,2022-11-21,ACTUAL,2022-11-21,,INTERVENTIONAL,,,Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis,"A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult Japanese Subjects With Moderate to Severe Palmoplantar Pustulosis",COMPLETED,,PHASE3,119.0,ACTUAL,AbbVie,,2.0,,,f,,,,f,f,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,INDUSTRY,,,,,,,2022,0.0
NCT02697617,,2015-10-30,2020-10-19,,2020-12-22,2016-02-26,2016-03-03,ESTIMATED,2020-12-22,2021-01-15,ACTUAL,,,,2020-12-22,2021-01-15,ACTUAL,2016-01-26,ACTUAL,2016-01-26,2020-12,2020-12-31,2020-01,ACTUAL,2020-01-31,2019-10,ACTUAL,2019-10-31,,INTERVENTIONAL,PIOPKD,18 patients randomized to either pioglitazone for 12 months and then placebo for 12 months and then cross over to the other arm. So baseline data represents both arms,Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney Disease,Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney,COMPLETED,,PHASE2,18.0,ACTUAL,Indiana University,The major limitation is the small sample size.,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,OTHER,,,,,,,2020,1.0
NCT04507438,,2020-03-05,,,2023-10-10,2020-08-07,2020-08-11,ACTUAL,,,,,,,2023-10-10,2023-10-13,ACTUAL,2019-07-12,ACTUAL,2019-07-12,2023-10,2023-10-31,2023-09-12,ACTUAL,2023-09-12,2023-09-12,ACTUAL,2023-09-12,,INTERVENTIONAL,,,The Effect of Donepezil on Glycemic Control in Type II Diabetics,The Effect of Donepezil on Glycemic Control in Type II Diabetics,TERMINATED,,PHASE2,7.0,ACTUAL,"University of Maryland, Baltimore",,2.0,,Lack of enrollment,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 07:56:06.936978,2024-10-16 07:56:06.936978,OTHER,,,,,,,2023,0.0
NCT02727998,,2016-03-14,2022-07-19,,2022-10-12,2016-03-30,2016-04-05,ESTIMATED,2022-10-12,2022-10-17,ACTUAL,,,,2022-10-12,2022-10-17,ACTUAL,2015-12,,2015-12-31,2022-10,2022-10-31,2021-11-28,ACTUAL,2021-11-28,2021-11-28,ACTUAL,2021-11-28,,INTERVENTIONAL,PTSD,,Intensive 7-day Treatment for PTSD Combining Ketamine With Exposure Therapy,Combining Neurobiology and New Learning: Ketamine and Prolonged Exposure: A Potential Rapid Treatment for Post Traumatic Stress Disorder (PTSD),TERMINATED,,PHASE2,28.0,ACTUAL,Yale University,"Due to study termination, full enrollment was not achieved and therefore the intended regression modeling was not performed.",2.0,,Study ran out of funding,f,,,,f,t,f,,,t,,,,,,NO,Data from the initial stage of the investigation will be used to establish support for a Phase 3 RCT.,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,OTHER,,,,,,,2021,0.0
NCT01436656,,2011-04-14,,,2023-08-14,2011-09-19,2011-09-20,ESTIMATED,,,,,,,2023-08-14,2023-08-16,ACTUAL,2011-09-05,ACTUAL,2011-09-05,2023-08,2023-08-31,2022-11-07,ACTUAL,2022-11-07,2012-10-01,ACTUAL,2012-10-01,,INTERVENTIONAL,,,A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma,"A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LGX818 in Adult Patients With Locally Advanced or Metastatic BRAF Mutant Melanoma",COMPLETED,,PHASE1,93.0,ACTUAL,Pfizer,,2.0,,,f,,,,f,,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,INDUSTRY,,,,,,,2022,1.0
NCT03672643,,2018-07-19,,,2023-10-17,2018-09-13,2018-09-14,ACTUAL,,,,,,,2023-10-17,2023-10-19,ACTUAL,2019-01-28,ACTUAL,2019-01-28,2023-10,2023-10-31,2023-09-28,ACTUAL,2023-09-28,2023-09-28,ACTUAL,2023-09-28,,INTERVENTIONAL,,,Long Term Safety Observation of Crizotinib in Chinese NSCLC Population,"AN OPEN-LABEL, SINGLE-ARM STUDY OF THE LONG-TERM SAFETY OF XALKORI (REGISTERED) IN PATIENTS FROM CHINA WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) OR ROS1 LOCUS WHO HAVE PREVIOUSLY BEEN TREATED ON A STUDY OF XALKORI (REGISTERED)",TERMINATED,,PHASE4,41.0,ACTUAL,Pfizer,,1.0,,"The trial is terminated based on business decision, not due to safety concerns or regulatory requirements.",f,,,,f,f,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 10:52:23.471115,2024-10-15 10:52:23.471115,INDUSTRY,,,,,,,2023,0.0
NCT04879823,,2021-05-04,2024-07-10,,2024-08-29,2021-05-04,2021-05-10,ACTUAL,2024-08-29,2024-09-05,ACTUAL,,,,2024-08-29,2024-09-05,ACTUAL,2021-08-05,ACTUAL,2021-08-05,2024-08,2024-08-31,2023-07-11,ACTUAL,2023-07-11,2023-07-11,ACTUAL,2023-07-11,,INTERVENTIONAL,,Excludes patients withdrawn due to protocol violation and physician decision,Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity,Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity,TERMINATED,,PHASE3,222.0,ACTUAL,University of Pittsburgh,Early termination due to slow recruitment in older cohorts (8-12 and 13-17-year-olds) leading to small numbers of subjects analyzed in those age groups.,2.0,,slow recruitment,f,,,,f,t,f,,,f,,,,,,NO,Only co-investigators as listed under the University of Pittsburgh IRB (Institutional Review Board) protocol for this study will have access to all data and analysis. Data will be shared via UPMC-associated OneDrive and will only be shared between these investigators.,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,OTHER,,,,,,,2023,0.0
NCT03266991,,2017-08-11,,,2023-10-10,2017-08-28,2017-08-30,ACTUAL,,,,,,,2023-10-10,2023-10-12,ACTUAL,2017-10-27,ACTUAL,2017-10-27,2021-07,2021-07-31,2023-02-09,ACTUAL,2023-02-09,2023-02-09,ACTUAL,2023-02-09,,INTERVENTIONAL,DOT-LTBI,,Treatment of Latent Tuberculosis in Socially Marginalised Citizens,A Randomised Controlled Trial of a 12-dose Rifapentine and Isoniazid (RPT+INH) Regimen Using Direct Observed Therapy (DOT) Versus 6 Months of Daily Isoniazid for Latent Tuberculosis Infection (LTBI) in Socially Marginalised People,TERMINATED,,PHASE4,22.0,ACTUAL,Aarhus University Hospital,,2.0,,Recruitment issues,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 10:52:23.471115,2024-10-15 10:52:23.471115,OTHER,,,,,,,2023,0.0
NCT03018288,,2017-01-11,2023-12-14,,2024-07-02,2017-01-11,2017-01-12,ESTIMATED,2024-02-05,2024-02-28,ACTUAL,,,,2024-07-02,2024-07-25,ACTUAL,2017-09-21,ACTUAL,2017-09-21,2024-07,2024-07-31,2022-12-20,ACTUAL,2022-12-20,2022-12-20,ACTUAL,2022-12-20,,INTERVENTIONAL,,,Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM),"A Randomized, Double Blind Phase II Trial of Surgery, Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)",TERMINATED,,PHASE2,90.0,ACTUAL,National Institutes of Health Clinical Center (CC),,4.0,,Study closed early due to poor accrual.,f,,,,t,t,f,,,,,,Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active. All collected individual participant data (IPD) will be available after primary analysis has been published.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.,,YES,"All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP). All collected IPD will be shared with collaborators under the terms of collaborative agreements.",2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,NIH,,,,,,,2022,0.0
NCT04382898,,2020-04-21,,,2024-05-16,2020-05-08,2020-05-11,ACTUAL,,,,,,,2024-05-16,2024-05-17,ACTUAL,2019-12-19,ACTUAL,2019-12-19,2024-05,2024-05-31,2024-01-23,ACTUAL,2024-01-23,2024-01-23,ACTUAL,2024-01-23,,INTERVENTIONAL,PRO-MERIT,,PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy),"First-in-human, Dose Titration and Expansion Trial to Evaluate Safety, Immunogenicity and Preliminary Efficacy of W_pro1 (BNT112) Monotherapy and in Combination With Cemiplimab in Patients With Prostate Cancer",TERMINATED,,PHASE1/PHASE2,75.0,ACTUAL,BioNTech SE,,6.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 07:56:06.936978,2024-10-16 07:56:06.936978,INDUSTRY,,,,,,,2024,0.0
NCT04065087,,2019-07-25,,,2022-03-02,2019-08-21,2019-08-22,ACTUAL,,,,,,,2022-03-02,2022-03-17,ACTUAL,2019-08-22,ESTIMATED,2019-08-22,2022-03,2022-03-31,2022-08-27,ESTIMATED,2022-08-27,2022-05-27,ESTIMATED,2022-05-27,,INTERVENTIONAL,,,Efficacy and Safety Study of GX-I7 Plus Adjuvant Temozolomide Combination in Patients With Newly Diagnosed Glioblastoma,"A Phase 1/2, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability, Anti-tumor Activity of GX-I7 Plus Adjuvant Temozolomide Combination Regimen in Patients With Newly Diagnosed With Glioblastoma",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Genexine, Inc.",,2.0,,Canceled by the sponsor,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 07:56:06.936978,2024-10-16 07:56:06.936978,INDUSTRY,,,,,,,2022,0.0
NCT03056495,,2016-12-27,,,2024-04-09,2017-02-14,2017-02-17,ACTUAL,,,,,,,2024-04-09,2024-04-10,ACTUAL,2017-09-28,ACTUAL,2017-09-28,2019-07,2019-07-31,2024-03-04,ACTUAL,2024-03-04,2024-03-04,ACTUAL,2024-03-04,,INTERVENTIONAL,VostatAD01,,Clinical Trial to Determine Tolerable Dosis of Vorinostat in Patients With Mild Alzheimer Disease,"Multicenter, Open-label Phase Ib Dose-escalation and Dose-confirmational Study for the Tolerability and Safety of N-hydroxy-N'-Phenyl-octanediamide (Vorinostat) in Patients With Mild Alzheimer's Disease",TERMINATED,,PHASE1,9.0,ACTUAL,German Center for Neurodegenerative Diseases (DZNE),,1.0,,Insufficient Recruitment,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 07:56:06.936978,2024-10-16 07:56:06.936978,OTHER,,,,,,,2024,0.0
NCT02709993,,2016-03-07,,,2019-10-10,2016-03-10,2016-03-16,ESTIMATED,,,,,,,2019-10-10,2019-10-14,ACTUAL,2017-07-28,ACTUAL,2017-07-28,2019-08,2019-08-31,2020-10-31,ESTIMATED,2020-10-31,2020-10-31,ESTIMATED,2020-10-31,,INTERVENTIONAL,,,Consolidation Therapy in Patients With Hematologic Malignancies,"Phase I/II Study of Low-Dose Cyclophosphamide, Tumor Associated Peptide Antigen-Pulsed Dendritic Cell Therapy and Low Dose GM-CSF, As Consolidation Treatment in Patients With Hematologic Malignancies",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Kiromic BioPharma Inc.,,1.0,,Study unable to enroll patients,f,,,,t,t,f,,,,,,,,,,,2024-10-16 07:56:06.936978,2024-10-16 07:56:06.936978,INDUSTRY,,,,,,,2020,0.0
NCT02902055,,2016-09-12,,,2024-01-12,2016-09-12,2016-09-15,ESTIMATED,,,,,,,2024-01-12,2024-01-17,ACTUAL,2019-12-01,ACTUAL,2019-12-01,2024-01,2024-01-31,2024-05-01,ESTIMATED,2024-05-01,2024-05-01,ESTIMATED,2024-05-01,,INTERVENTIONAL,PAN,,Paediatric Ards Neuromuscular Blockade Study,"Life-threatening Acute Respiratory Failure in Children: to Breathe or Not to Breathe Spontaneously, That's the Question",SUSPENDED,,PHASE4,178.0,ESTIMATED,University Medical Center Groningen,,2.0,,COVID,f,,,,t,f,f,,,,,,,,,YES,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,OTHER,,,,,,,2024,0.0
NCT03322215,,2017-09-28,,,2024-03-06,2017-10-24,2017-10-26,ACTUAL,,,,,,,2024-03-06,2024-03-08,ACTUAL,2017-10-24,ACTUAL,2017-10-24,2023-05,2023-05-31,2023-10-31,ACTUAL,2023-10-31,2021-04-30,ACTUAL,2021-04-30,,INTERVENTIONAL,PASIPHAE,,HR+/HER2- Advanced Breast Cancer and Endocrine Resistance,"A Phase 2, International, Multicenter, Open-labeled, Randomized Trial of PAlbociclib and Fulvestrant vs. Standard Oral Capecitabine In Patients With Hormone Receptor (HR)+ / HER2- Advanced Breast Cancer and Documented Endocrine Resistance",TERMINATED,,PHASE2,42.0,ACTUAL,Karolinska University Hospital,,2.0,,Slow accrual,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 10:52:23.471115,2024-10-15 10:52:23.471115,OTHER,,,,,,,2023,0.0
NCT02579265,,2015-10-15,2021-08-20,2021-03-17,2021-12-08,2015-10-15,2015-10-19,ESTIMATED,2021-12-08,2022-01-05,ACTUAL,2021-03-23,2021-03-26,ACTUAL,2021-12-08,2022-01-05,ACTUAL,2015-12,ACTUAL,2015-12-31,2021-12,2021-12-31,2020-04-10,ACTUAL,2020-04-10,2020-04-03,ACTUAL,2020-04-03,,INTERVENTIONAL,,,Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants,"A Prospective, Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants Requiring 28 Days of Parenteral Nutrition",TERMINATED,,PHASE3,204.0,ACTUAL,Fresenius Kabi,,2.0,,Outcome of a planned interim analysis was that the sample size required to show superiority was too high to be feasible. Fresenius Kabi requested termination to the FDA on 17 Jan 2020. FDA accepted termination by written response on 16 Apr 2020.,f,,,,t,,,,,,,,,,,,,2024-10-15 10:52:23.471115,2024-10-15 10:52:23.471115,INDUSTRY,,,,,,,2020,0.0
NCT03862079,,2019-03-01,,,2020-03-02,2019-03-01,2019-03-05,ACTUAL,,,,,,,2020-03-02,2020-03-04,ACTUAL,2020-06-01,ESTIMATED,2020-06-01,2020-03,2020-03-31,2021-12-31,ESTIMATED,2021-12-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Fecal Transplant +/- Gut Decontamination in Preventing Acute Graft Versus Host Disease in Patients Given Broad-Spectrum Antibiotics,"Randomized Phase II Trial of Total Gut Decontamination Followed by Fecal Microbiota Transplant (FMT), FMT-Alone or Standard of Care for Reduction in Acute Graft-Versus-Host Disease of the Gastrointestinal Tract in Patients Given Broad-Spectrum Antibiotics",WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,3.0,,Per PI's request,f,,,,t,t,f,,,,,,,,,,,2024-10-16 07:56:06.936978,2024-10-16 07:56:06.936978,OTHER,,,,,,,2021,0.0
NCT03552575,,2018-05-29,2021-08-24,,2023-04-28,2018-05-29,2018-06-12,ACTUAL,2023-04-28,2023-05-03,ACTUAL,,,,2023-04-28,2023-05-03,ACTUAL,2018-07-01,ACTUAL,2018-07-01,2022-04,2022-04-30,2020-07-25,ACTUAL,2020-07-25,2020-07-25,ACTUAL,2020-07-25,,INTERVENTIONAL,RECOVER-LV,,The Effects of Sacubitril/Valsartan Compared to Valsartan on LV Remodelling in Asymptomatic LV Systolic Dysfunction After MI,"The Effects of Sacubitril/Valsartan Compared to Valsartan on Left Ventricular Remodelling in Asymptomatic Left Ventricular Systolic Dysfunction After Myocardial Infarction: a Randomised, Double-blinded, Active-comparator, Cardiac-MR Based Trial",COMPLETED,,PHASE3,93.0,ACTUAL,NHS Greater Glasgow and Clyde,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 10:52:23.471115,2024-10-15 10:52:23.471115,OTHER,,,,,,,2020,1.0
NCT04407442,,2020-05-22,2024-04-03,,2024-04-03,2020-05-27,2020-05-29,ACTUAL,2024-04-03,2024-04-30,ACTUAL,,,,2024-04-03,2024-04-30,ACTUAL,2020-11-30,ACTUAL,2020-11-30,2024-03,2024-03-31,2023-04-30,ACTUAL,2023-04-30,2023-04-30,ACTUAL,2023-04-30,,INTERVENTIONAL,,,"Daratumumab, Azacitidine, and Dexamethasone for Treatment of Patients With Recurrent or Refractory Multiple Myeloma Previously Treated With Daratumumab",Phase II Study of Daratumumab in Combination With Azacitidine and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients Previously Treated With Daratumumab,TERMINATED,,PHASE2,5.0,ACTUAL,"University of California, San Francisco",The study was closed to enrollment earlier than expected due to slow enrollment and change in sponsor research direction.,1.0,,Slow enrollment and change in sponsor direction,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,OTHER,,,,,,,2023,0.0
NCT04783389,,2021-02-24,2023-06-04,,2023-09-25,2021-03-02,2021-03-05,ACTUAL,2023-09-25,2023-10-17,ACTUAL,,,,2023-09-25,2023-10-17,ACTUAL,2021-06-16,ACTUAL,2021-06-16,2022-06,2022-06-30,2022-06-10,ACTUAL,2022-06-10,2022-04-15,ACTUAL,2022-04-15,,INTERVENTIONAL,,,"A Study to Evaluate CBP-201, Rademikibart, in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps","A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate CBP-201 in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps",TERMINATED,,PHASE2,40.0,ACTUAL,"Suzhou Connect Biopharmaceuticals, Ltd.","The study was prematurely discontinued after 40 patients were enrolled due to recruitment issues resulting from the COVID-19 pandemic and operational issues such as the inability to fully conduct/implement the study (e.g., monitoring, logistics of drug supply, transportation of clinical testing samples, etc.) due to the Russian invasion of Ukraine in Mar 2022.~Because only limited data was collected, no definitive conclusions can be made at the pre-planned 24-week primary endpoint.",3.0,,Trial was discontinued in 2022 due to COVID-19 pandemic and Ukraine/Russia conflict related enrollment challenges. Discontinuation was not related to safety.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 21:32:51.909156,2024-10-15 21:32:51.909156,INDUSTRY,,,,,,,2022,0.0
NCT04675086,,2020-11-25,,,2020-12-17,2020-12-17,2020-12-19,ACTUAL,,,,,,,2020-12-17,2020-12-21,ACTUAL,2021-01,ESTIMATED,2021-01-31,2020-12,2020-12-31,2021-12,ESTIMATED,2021-12-31,2021-09,ESTIMATED,2021-09-30,,INTERVENTIONAL,,,Aralast NP With Antiviral Treatment and Standard of Care Versus Antiviral Treatment With Standard of Care in Hospitalized Patients With Pneumonia and COVID-19 Infection,"A Randomized, Open-Label Study of the Efficacy and Safety of Aralast NP, an Alpha-1 Antitrypsin Infusion Therapy With Antiviral Treatment and Standard of Care Versus Antiviral Treatment With Standard of Care in Hospitalized Patients With Pneumonia and COVID-19 Infection",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Blessing Corporate Services, Inc",,2.0,,Administrative Decision,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,OTHER,,,,,,,2021,0.0
NCT03574649,,2018-06-21,,,2022-03-28,2018-06-29,2018-07-02,ACTUAL,,,,,,,2022-03-28,2022-04-05,ACTUAL,2018-09,ESTIMATED,2018-09-30,2018-06,2018-06-30,2020-12-30,ESTIMATED,2020-12-30,2019-12-30,ESTIMATED,2019-12-30,,INTERVENTIONAL,,,"QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer","QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer",WITHDRAWN,,PHASE2,0.0,ACTUAL,"ImmunityBio, Inc.",,2.0,,Trial not initiated,f,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,INDUSTRY,,,,,,,2020,0.0
NCT02169089,,2014-06-18,2023-05-22,,2023-07-10,2014-06-18,2014-06-20,ESTIMATED,2023-07-10,2023-08-01,ACTUAL,,,,2023-07-10,2023-08-01,ACTUAL,2016-01,ACTUAL,2016-01-31,2023-07,2023-07-31,2022-04-29,ACTUAL,2022-04-29,2022-04-29,ACTUAL,2022-04-29,,INTERVENTIONAL,,,Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial,Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial,COMPLETED,,PHASE4,79.0,ACTUAL,University Hospitals Cleveland Medical Center,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,OTHER,,,,,,,2022,1.0
NCT04349124,,2020-04-14,2023-01-06,2022-02-01,2023-03-07,2020-04-14,2020-04-16,ACTUAL,2023-03-07,2023-04-03,ACTUAL,,2023-04-03,ACTUAL,2023-03-07,2023-04-03,ACTUAL,2020-08-25,ACTUAL,2020-08-25,2023-03,2023-03-31,2021-03-04,ACTUAL,2021-03-04,2021-02-12,ACTUAL,2021-02-12,,INTERVENTIONAL,,Participants who completed the study.,Persistent Postpartum Hypertension Pilot Trial,Pilot Treatment of Persistent Non-Severe Postpartum Hypertension,TERMINATED,,PHASE4,12.0,ACTUAL,Duke University,,2.0,,Unable to continue recruiting,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,OTHER,,,,,,,2021,0.0
NCT02047513,,2014-01-09,,,2023-06-13,2014-01-27,2014-01-28,ESTIMATED,,,,,,,2023-06-13,2023-06-15,ACTUAL,2015-07,ACTUAL,2015-07-31,2023-06,2023-06-30,2022-10,ACTUAL,2022-10-31,2021-04,ACTUAL,2021-04-30,,INTERVENTIONAL,NEONAX,,Neoadjuvant Plus Adjuvant or Only Adjuvant Nab- Paclitaxel Plus Gemcitabine for Resectable Pancreatic Cancer,"Neoadjuvant Plus Adjuvant or Only Adjuvant Nab-Paclitaxel Plus Gemcitabine for Resectable Pancreatic Cancer: A Prospective, Randomized, Controlled, Phase II Study of the AIO (Working Group for Medical Oncology From the German Cancer Society) Pancreatic Cancer Group",COMPLETED,,PHASE2,127.0,ACTUAL,AIO-Studien-gGmbH,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 07:56:06.936978,2024-10-16 07:56:06.936978,OTHER,,,,,,,2022,0.0
NCT02578641,,2015-10-12,2022-12-22,,2023-06-07,2015-10-15,2015-10-19,ESTIMATED,2023-06-07,2023-06-28,ACTUAL,,,,2023-06-07,2023-06-28,ACTUAL,2014-07,ACTUAL,2014-07-31,2023-06,2023-06-30,2022-02-28,ACTUAL,2022-02-28,2022-02-28,ACTUAL,2022-02-28,,INTERVENTIONAL,VANCE,Intent-to-treat Analysis Set - all subjects randomized to treatment.,A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients,"A Multicentre, Randomized, Open-Label, Phase III Clinical Trial Of Gemcitabine And Carboplatin Followed By Epstein-Barr Virus-Specific Autologous Cytotoxic T Lymphocytes Versus Gemcitabine And Carboplatin As First Line Treatment For Advanced Nasopharyngeal Carcinoma(NPC) Patients",COMPLETED,,PHASE3,330.0,ACTUAL,Tessa Therapeutics,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,INDUSTRY,,,,,,,2022,1.0
NCT03330197,,2017-10-16,,,2021-11-03,2017-10-30,2017-11-06,ACTUAL,,,,,,,2021-11-03,2021-11-11,ACTUAL,2017-09-26,ACTUAL,2017-09-26,2021-11,2021-11-30,2021-09-10,ACTUAL,2021-09-10,2021-09-10,ACTUAL,2021-09-10,,INTERVENTIONAL,,,A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG,"A Phase I/II Study of Ad-RTS-hIL-12, an Inducible Adenoviral Vector Engineered to Express hIL-12 in the Presence of the Activator Ligand Veledimex in Pediatric Brain Tumor Subjects",TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,Alaunos Therapeutics,,2.0,,Sponsor decision due to slow accrual,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,INDUSTRY,,,,,,,2021,0.0
NCT03332589,,2017-10-30,2021-11-01,,2022-03-05,2017-11-01,2017-11-06,ACTUAL,2022-03-05,2022-05-20,ACTUAL,,,,2022-03-05,2022-05-20,ACTUAL,2018-07-02,ACTUAL,2018-07-02,2021-12,2021-12-31,2021-10-11,ACTUAL,2021-10-11,2021-04-30,ACTUAL,2021-04-30,,INTERVENTIONAL,,No subjects were enrolled in the Combination Safety Run-In or Expansion Phases of the study.,E6201 Plus Dabrafenib for the Treatment of Metastatic Melanoma Central Nervous System Metastases (CNS),A Phase 1 Study of E6201 Plus Dabrafenib for the Treatment of Central Nervous System Metastases (CNS) From BRAF V600-Mutated Metastatic Melanoma,TERMINATED,,PHASE1,4.0,ACTUAL,"Spirita Oncology, LLC","Due to the departure of the study PI from the institution, the study was terminated early.",3.0,,Single center study: Principal Investigator left institution.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,INDUSTRY,,,,,,,2021,0.0
NCT05525156,,2022-08-28,,,2022-08-30,2022-08-30,2022-09-01,ACTUAL,,,,,,,2022-08-30,2022-09-01,ACTUAL,2020-03-02,ACTUAL,2020-03-02,2022-08,2022-08-31,2023-06-22,ESTIMATED,2023-06-22,2022-06-22,ACTUAL,2022-06-22,,INTERVENTIONAL,,,The Effect of Aspirin on HIV Disease Progression Among HIV- Infected Individuals Initiating Anti- Retroviral Therapy,The Effect of Aspirin on HIV Disease Progression Among HIV- Infected Individuals Initiating Anti- Retroviral Therapy,SUSPENDED,,PHASE2,454.0,ESTIMATED,Muhimbili University of Health and Allied Sciences,,2.0,,The study stopped due to expiry of study drugs,f,,,,t,f,f,,,,,,From 9 months and to 36 months after article publication,Investigators with approval by an independent review committee for proposed use of data. Data will be shared for individual participant data meta analysis The mechanism by which data will be made available is that proposals may be submitted up to 36 months after respective article publication. after this period data will be made available at MUHAS data warehouse but without investigator support other than deposited metadata.,,YES,"Individual participant data that underlie the results reported in the respective article, after deidentification (text, tables, figures and appendices).",2024-10-15 10:52:23.471115,2024-10-15 10:52:23.471115,OTHER,,,,,,,2023,0.0
NCT04609397,,2020-10-19,,,2022-06-15,2020-10-25,2020-10-30,ACTUAL,,,,,,,2022-06-15,2022-06-21,ACTUAL,2020-11-30,ACTUAL,2020-11-30,2022-06,2022-06-30,2022-04-30,ACTUAL,2022-04-30,2022-04-30,ACTUAL,2022-04-30,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease,A Phase Ⅱ Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease,TERMINATED,,PHASE2,89.0,ACTUAL,"Ganzhou Hemay Pharmaceutical Co., Ltd",,3.0,,The study purpose has been achieved,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,INDUSTRY,,,,,,,2022,0.0
NCT04031833,,2019-07-22,,,2023-03-29,2019-07-22,2019-07-24,ACTUAL,,,,,,,2023-03-29,2023-03-31,ACTUAL,2019-10-24,ACTUAL,2019-10-24,2023-03,2023-03-31,2023-02-15,ACTUAL,2023-02-15,2022-11-14,ACTUAL,2022-11-14,,INTERVENTIONAL,EnACT,,Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT),Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial,COMPLETED,,PHASE1/PHASE2,178.0,ACTUAL,"Matinas BioPharma Nanotechnologies, Inc.",,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:52:23.471115,2024-10-15 10:52:23.471115,INDUSTRY,,,,,,,2023,1.0
NCT04130399,,2019-10-15,,,2019-10-15,2019-10-15,2019-10-17,ACTUAL,,,,,,,2019-10-15,2019-10-17,ACTUAL,2019-07-01,ESTIMATED,2019-07-01,2019-09,2019-09-30,2023-01-01,ESTIMATED,2023-01-01,2022-01-01,ESTIMATED,2022-01-01,,INTERVENTIONAL,,,Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer,Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,Indiana University,,1.0,,Study is being abandoned.,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 10:52:23.471115,2024-10-15 10:52:23.471115,OTHER,,,,,,,2023,0.0
NCT05698888,,2022-12-12,,,2023-09-15,2023-01-16,2023-01-26,ACTUAL,,,,,,,2023-09-15,2023-09-21,ACTUAL,2022-11-29,ACTUAL,2022-11-29,2023-09,2023-09-30,2023-06-19,ACTUAL,2023-06-19,2023-06-19,ACTUAL,2023-06-19,,INTERVENTIONAL,,,"Study of VP301 in Patients With Multiple Myeloma, Lymphoma, or Solid Tumors","A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VP301 in Patients With Relapsed or Refractory Multiple Myeloma, Lymphoma, or Solid Tumors",TERMINATED,,PHASE1,2.0,ACTUAL,"Virtuoso BINco, Inc.",,2.0,,Sponsor Decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,INDUSTRY,,,,,,,2023,0.0
NCT04728347,,2021-01-24,,,2022-07-07,2021-01-24,2021-01-28,ACTUAL,,,,,,,2022-07-07,2022-07-08,ACTUAL,2021-01-04,ACTUAL,2021-01-04,2022-07,2022-07-31,2021-12-28,ACTUAL,2021-12-28,2021-12-28,ACTUAL,2021-12-28,,INTERVENTIONAL,,,Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021,"A Phase 2a, Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021",TERMINATED,,PHASE2,65.0,ACTUAL,"Arcturus Therapeutics, Inc.",,2.0,,A decision was made to terminate the study for operational/business reasons. This study was not terminated for reasons of safety or immunogenicity.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,INDUSTRY,,,,,,,2021,0.0
NCT04620733,,2020-11-04,2024-07-01,2023-09-26,2024-08-13,2020-11-04,2020-11-09,ACTUAL,2024-07-01,2024-07-25,ACTUAL,,2023-09-29,ACTUAL,2024-08-13,2024-09-05,ACTUAL,2021-04-21,ACTUAL,2021-04-21,2024-08,2024-08-31,2023-08-11,ACTUAL,2023-08-11,2023-08-11,ACTUAL,2023-08-11,,INTERVENTIONAL,,The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug.,RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA),"RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)",COMPLETED,,PHASE3,193.0,ACTUAL,Gilead Sciences,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,INDUSTRY,,,,,,,2023,1.0
NCT04520620,,2020-07-22,,,2020-08-19,2020-08-19,2020-08-20,ACTUAL,,,,,,,2020-08-19,2020-08-20,ACTUAL,2020-05-02,ACTUAL,2020-05-02,2020-07,2020-07-31,2020-07-10,ACTUAL,2020-07-10,2020-07-10,ACTUAL,2020-07-10,,INTERVENTIONAL,COV-ENOX,,Concentration-effect Relationship of Enoxaparin for Thromboembolic Prevention,Evaluation of the Concentration-effect Relationship of Enoxaparin for Thromboembolic Prevention in COVID-19 Intensive Unit Care Patients.,WITHDRAWN,,PHASE4,0.0,ACTUAL,Centre Hospitalier Universitaire de Saint Etienne,,1.0,,End of the COVID 19 epidemic in the region and decision to participate in a national study on the same subject (COVI-DOSE).,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,OTHER,,,,,,,2020,0.0
NCT02285062,,2014-11-04,2020-03-13,,2023-05-22,2014-11-04,2014-11-06,ESTIMATED,2020-03-13,2020-03-30,ACTUAL,,,,2023-05-22,2023-06-22,ACTUAL,2015-02-17,ACTUAL,2015-02-17,2023-05,2023-05-31,2022-07-28,ACTUAL,2022-07-28,2019-03-15,ACTUAL,2019-03-15,,INTERVENTIONAL,ROBUST,"The Intent-to-treat (ITT) population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.",Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma,"Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of Lenalidomide (CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects With Previously Untreated Activated B-cell Type Diffuse Large B-cell Lymphoma",COMPLETED,,PHASE3,570.0,ACTUAL,Celgene,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,INDUSTRY,,,,,,,2022,1.0
NCT02164578,,2014-06-12,2021-02-26,,2023-01-26,2014-06-13,2014-06-16,ESTIMATED,2023-01-26,2023-11-07,ACTUAL,,,,2023-01-26,2023-11-07,ACTUAL,2015-04,ACTUAL,2015-04-30,2023-01,2023-01-31,2020-04-30,ACTUAL,2020-04-30,2018-12-12,ACTUAL,2018-12-12,,INTERVENTIONAL,MicroVasc-DIVA,Baseline characteristics were assessed for the full analysis set (n=179),Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Aspirin in Type-2 Diabetic Patients With Subclinical Inflammation and High Cardiovascular Risk,Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Low Dose Aspirin in Type-2 Diabetic Patients With Very High Cardiovascular Risk and Subclinical Inflammation,COMPLETED,,PHASE3,179.0,ACTUAL,GWT-TUD GmbH,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,OTHER,,,,,,,2020,1.0
NCT02261519,,2014-09-25,,,2024-05-22,2014-10-06,2014-10-10,ESTIMATED,,,,,,,2024-05-22,2024-05-24,ACTUAL,2017-03-29,ACTUAL,2017-03-29,2024-05,2024-05-31,2023-11-29,ACTUAL,2023-11-29,2023-11-29,ACTUAL,2023-11-29,,INTERVENTIONAL,,,Study to Evaluate Safety & Efficacy of NaBen® as Add-on Treatment for Schizophrenia in Adults,"An Adaptive, Phase IIb/III, Multi-center, Prospective, Randomized, Double-Blind Placebo-controlled Study of the Safety and Efficacy of NaBen® (DAAO Inhibitor), as an Add-on Treatment for Schizophrenia in Adults",TERMINATED,,PHASE2/PHASE3,280.0,ACTUAL,SyneuRx International (Taiwan) Corp,,2.0,,due to commercial strategy,f,,,,t,t,f,,,,,,,,,,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,INDUSTRY,,,,,,,2023,0.0
NCT04958434,,2021-06-17,,,2023-10-19,2021-07-01,2021-07-12,ACTUAL,,,,,,,2023-10-19,2023-10-23,ACTUAL,2021-06-11,ACTUAL,2021-06-11,2023-08,2023-08-31,2023-09-30,ACTUAL,2023-09-30,2023-09-30,ACTUAL,2023-09-30,,INTERVENTIONAL,,,Study of TST005 in Patients With Locally Advanced or Metastatic Solid Tumors,"A Phase 1, First in Human, Open-label, Dose Escalation and Dose Expansion Study of TST005 in Patients With Locally Advanced or Metastatic Solid Tumors",TERMINATED,,PHASE1,19.0,ACTUAL,"Suzhou Transcenta Therapeutics Co., Ltd.",,2.0,,Corporate Decision,,,,,f,t,f,,,,,,,,,NO,individual participant data (IPD) will not be shared to other researchers,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,INDUSTRY,,,,,,,2023,0.0
NCT03537534,,2018-05-15,,,2024-02-23,2018-05-15,2018-05-25,ACTUAL,,,,,,,2024-02-23,2024-02-26,ACTUAL,2018-04-15,ACTUAL,2018-04-15,2024-02,2024-02-29,2022-09-01,ACTUAL,2022-09-01,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,,,Intraurethral Lidocaine After Endourology Procedures,Intraurethral Lidocaine After Endourology Procedure to Improve Dysuria in Anesthetized Patients,TERMINATED,,PHASE3,35.0,ACTUAL,San Antonio Uniformed Services Health Education Consortium,,2.0,,Lack of enrollment,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,FED,,,,,,,2022,0.0
NCT03522844,,2018-05-01,,,2022-01-07,2018-05-01,2018-05-11,ACTUAL,,,,,,,2022-01-07,2022-01-11,ACTUAL,2018-06-18,ACTUAL,2018-06-18,2022-01,2022-01-31,2022-01-05,ACTUAL,2022-01-05,2021-10-31,ACTUAL,2021-10-31,,INTERVENTIONAL,TAME,,Treatments for Anxiety: Meditation and Escitalopram,Comparative Effectiveness of Mindfulness-Based Stress Reduction and Pharmacotherapy for Anxiety,COMPLETED,,PHASE4,276.0,ACTUAL,Georgetown University,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,OTHER,,,,,,,2022,1.0
NCT02854436,,2016-08-01,2022-01-25,,2024-08-13,2016-08-01,2016-08-03,ESTIMATED,2022-03-07,2022-03-08,ACTUAL,,,,2024-08-13,2024-09-05,ACTUAL,2016-08-31,ACTUAL,2016-08-31,2024-07,2024-07-31,2023-08-16,ACTUAL,2023-08-16,2021-01-26,ACTUAL,2021-01-26,,INTERVENTIONAL,Galahad,,An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies,A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies,COMPLETED,,PHASE2,289.0,ACTUAL,"Janssen Research & Development, LLC",,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,INDUSTRY,,,,,,,2023,1.0
NCT03994926,,2019-06-12,,,2021-09-27,2019-06-20,2019-06-21,ACTUAL,,,,,,,2021-09-27,2021-10-01,ACTUAL,2020-02-03,ACTUAL,2020-02-03,2021-09,2021-09-30,2020-03-13,ACTUAL,2020-03-13,2020-03-13,ACTUAL,2020-03-13,,INTERVENTIONAL,,,Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment,Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment,TERMINATED,,EARLY_PHASE1,3.0,ACTUAL,Battelle Memorial Institute,,1.0,,COVID-19 Pandmic halted study,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 07:56:06.936978,2024-10-16 07:56:06.936978,OTHER,,,,,,,2020,0.0
NCT03450018,,2018-02-13,,,2024-05-23,2018-02-22,2018-03-01,ACTUAL,,,,,,,2024-05-23,2024-05-24,ACTUAL,2019-01-10,ACTUAL,2019-01-10,2024-05,2024-05-31,2024-05-16,ACTUAL,2024-05-16,2024-05-16,ACTUAL,2024-05-16,,INTERVENTIONAL,SLC-0111-17-01,,A Study of SLC-0111 and Gemcitabine for Metastatic Pancreatic Ductal Cancer in Subjects Positive for CAIX,"An Open-label, Multi-center, Phase 1b Study to Investigate the Safety and Tolerability of SLC-0111 (WBI-5111) in Combination With Gemcitabine in Metastatic Pancreatic Ductal Adenocarcinoma Subjects Positive for Carbonic Anhydrase IX",TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,British Columbia Cancer Agency,,1.0,,Changing treatment landscape: The availability of nab-paclitaxel with gemcitabine in the second-line setting has changed the feasibility of further recruitment and potential long-term development opportunities of SLC-0111 with gemcitabine alone.,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,OTHER,,,,,,,2024,0.0
NCT03777657,,2018-11-09,,2024-02-05,2024-09-03,2018-12-14,2018-12-17,ACTUAL,,,,,2024-02-07,ACTUAL,2024-09-03,2024-09-05,ACTUAL,2018-12-13,ACTUAL,2018-12-13,2024-05,2024-05-31,2024-08-27,ACTUAL,2024-08-27,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,,,"Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma","A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) Plus Platinum and Fluoropyrimidine Versus Placebo Plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma",COMPLETED,,PHASE3,997.0,ACTUAL,BeiGene,,2.0,,,f,,,,,t,f,,,,,,,,,YES,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,INDUSTRY,,,,,,,2024,1.0
NCT03394287,,2018-01-02,,,2020-10-21,2018-01-06,2018-01-09,ACTUAL,,,,,,,2020-10-21,2020-10-23,ACTUAL,2018-01-10,ACTUAL,2018-01-10,2020-10,2020-10-31,2020-09-30,ACTUAL,2020-09-30,2019-12-30,ACTUAL,2019-12-30,,INTERVENTIONAL,,,A Trial of SHR-1210 (an Anti-PD-1 Antibody) in Combination With Apatinib in Patients With Advanced TNBC,"A Phase II, Open-labeled, Randomised, Non-comparative, Two-arms Investigator-initiated Clinical Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib in Subjects With Advanced Triple Negative Breast Cancer",COMPLETED,,PHASE2,40.0,ACTUAL,Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University,,2.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 10:52:23.471115,2024-10-15 10:52:23.471115,OTHER,,,,,,,2020,1.0
NCT04037527,,2019-07-26,,,2024-05-28,2019-07-26,2019-07-30,ACTUAL,,,,,,,2024-05-28,2024-05-29,ACTUAL,2020-08-18,ACTUAL,2020-08-18,2024-05,2024-05-31,2024-09,ESTIMATED,2024-09-30,2024-09,ESTIMATED,2024-09-30,,INTERVENTIONAL,,,Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities,Phase I Trial Study of Gemcitabine and Docetaxel With Radiation in Adult Patients With High Grade and Greater Than 5 cm Soft Tissue Sarcoma of the Extremities,SUSPENDED,,PHASE1,27.0,ESTIMATED,Wake Forest University Health Sciences,,1.0,,"Per the PI, this study is on hold to accrual pending an amendment that will need to be submitted to the IRB.",f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 10:52:23.471115,2024-10-15 10:52:23.471115,OTHER,,,,,,,2024,0.0
NCT03953209,,2019-04-18,,,2024-08-30,2019-05-14,2019-05-16,ACTUAL,,,,,,,2024-08-30,2024-09-04,ACTUAL,2020-03-05,ACTUAL,2020-03-05,2024-08,2024-08-31,2021-01-01,ACTUAL,2021-01-01,2021-01-01,ACTUAL,2021-01-01,,INTERVENTIONAL,,,Spironolactone for the Treatment of Melasma,"Spironolactone for the Treatment of Melasma: a Prospective, Open-label Proof-of-concept and Dose-ranging Study",WITHDRAWN,,PHASE1,0.0,ACTUAL,Medical University of South Carolina,,3.0,,Conflict with funding,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,OTHER,,,,,,,2021,0.0
NCT03386344,,2017-12-21,2021-04-16,2020-05-01,2021-06-03,2017-12-21,2017-12-29,ACTUAL,2021-06-03,2021-06-25,ACTUAL,2021-06-03,2021-06-25,ACTUAL,2021-06-03,2021-06-25,ACTUAL,2018-02-19,ACTUAL,2018-02-19,2021-06,2021-06-30,2020-05-30,ACTUAL,2020-05-30,2019-05-22,ACTUAL,2019-05-22,,INTERVENTIONAL,SOTA-BONE,The randomized population included any participant who had been allocated to a randomized treatment regardless of whether the treatment kit was used.,Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control,"A 26-week Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study With a 78-week Extension Period to Evaluate the Efficacy and Bone Safety of Sotagliflozin in Patients 55 Years or Older With Type 2 Diabetes Mellitus and Inadequate Glycemic Control",TERMINATED,,PHASE3,376.0,ACTUAL,Lexicon Pharmaceuticals,,3.0,,Study terminated prematurely for financial reasons and Covid-19 pandemic.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,INDUSTRY,,,,,,,2020,0.0
NCT04263142,,2020-02-06,2021-02-09,,2021-02-09,2020-02-06,2020-02-10,ACTUAL,2021-02-09,2021-03-03,ACTUAL,,,,2021-02-09,2021-03-03,ACTUAL,2020-01-27,ACTUAL,2020-01-27,2021-02,2021-02-28,2020-03-24,ACTUAL,2020-03-24,2020-03-24,ACTUAL,2020-03-24,,INTERVENTIONAL,,,A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants,"A Two-Part, Randomized, Open-Label, Single Dose, Crossover Clinical Trial to Assess the Relative Bioavailability of a Tablet Compared to a Capsule of GSK3640254 and to Assess the Effect of Food on the GSK3640254 Tablet in Healthy Participants",COMPLETED,,PHASE1,39.0,ACTUAL,ViiV Healthcare,,5.0,,,f,,,,f,t,f,,,,,,IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,INDUSTRY,,,,,,,2020,1.0
NCT03573986,,2018-06-20,,,2020-02-13,2018-06-28,2018-06-29,ACTUAL,,,,,,,2020-02-13,2020-02-17,ACTUAL,2018-04-18,ACTUAL,2018-04-18,2020-02,2020-02-29,2020-01-14,ACTUAL,2020-01-14,2020-01-14,ACTUAL,2020-01-14,,INTERVENTIONAL,,,Pilot Study of 18F-FMISO PET/CT and MRI Imaging to Explore Tissue Hypoxia and Arteriovenous Shunting in Subjects With Recurrent Glioblastoma Before and After Bevacizumab Treatment,Pilot Study of 18F-FMISO PET/CT and MRI Imaging to Explore Tissue Hypoxia and Arteriovenous Shunting in Subjects With Recurrent Glioblastoma Before and After Bevacizumab Treatment,TERMINATED,,PHASE1,2.0,ACTUAL,Abramson Cancer Center at Penn Medicine,,1.0,,Lack of enrollment,f,,,,t,t,f,,,,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,OTHER,,,,,,,2020,0.0
NCT03240393,,2017-07-26,,,2018-07-24,2017-08-01,2017-08-07,ACTUAL,,,,,,,2018-07-24,2018-07-26,ACTUAL,2018-07-31,ESTIMATED,2018-07-31,2018-07,2018-07-31,2021-10-26,ESTIMATED,2021-10-26,2021-10-26,ESTIMATED,2021-10-26,,INTERVENTIONAL,,,Study of Oral cMET Inhibitor INC280 in Chinese Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (NSCLC),Phase II Multicenter 3-cohort Study of Oral cMET Inhibitor INC280 in Chinese Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Received 1 or 2 Prior Lines of Systemic Therapy for Advanced/Metastatic Disease,WITHDRAWN,,PHASE2,0.0,ACTUAL,Novartis,,3.0,,Company Decision,f,,,,f,f,f,,,,,,,,,UNDECIDED,"Planned Shared Data Description: Copy and paste this Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,INDUSTRY,,,,,,,2021,0.0
NCT03608774,,2018-06-28,2020-09-25,,2020-12-10,2018-07-30,2018-08-01,ACTUAL,2020-12-10,2021-01-07,ACTUAL,,,,2020-12-10,2021-01-07,ACTUAL,2018-07-13,ACTUAL,2018-07-13,2019-01-25,2019-01-25,2020-02-21,ACTUAL,2020-02-21,2020-02-21,ACTUAL,2020-02-21,,INTERVENTIONAL,,"All randomized subjects, receiving or not receiving the study product, are included in the baseline analysis population.",Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM,"A Phase 4, Randomized, Double-Blinded, Placebo-Controlled Trial of Azithromycin Versus Doxycycline for the Treatment of Rectal Chlamydia in Men Who Have Sex With Men",COMPLETED,,PHASE4,177.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,,f,f,,,f,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,NIH,,,,,,,2020,1.0
NCT04421456,,2020-05-27,2023-03-16,,2023-06-13,2020-06-04,2020-06-09,ACTUAL,2023-06-13,2023-06-15,ACTUAL,,,,2023-06-13,2023-06-15,ACTUAL,2020-08-18,ACTUAL,2020-08-18,2023-06,2023-06-30,2022-03-16,ACTUAL,2022-03-16,2022-03-16,ACTUAL,2022-03-16,,INTERVENTIONAL,,Demographics and baseline characteristics were assessed in the Full Analysis Set in the Treatment Period.,Trial to Investigate the Safety and Efficacy of GWP42003-P Versus Placebo as Adjunctive Therapy in Participants With Schizophrenia Experiencing Inadequate Response to Ongoing Antipsychotic Treatment,"A Randomized, Double-blind, Parallel-group Trial to Investigate the Safety and Efficacy of GWP42003-P Versus Placebo as Adjunctive Therapy in Participants With Schizophrenia Experiencing Inadequate Response to Ongoing Antipsychotic Treatment",TERMINATED,,PHASE2,95.0,ACTUAL,Jazz Pharmaceuticals,,3.0,,This study was terminated based on a business decision by the Sponsor.,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 21:38:20.104762,2024-10-15 21:38:20.104762,INDUSTRY,,,,,,,2022,0.0
NCT04547101,,2020-09-07,,,2022-10-17,2020-09-07,2020-09-14,ACTUAL,,,,,,,2022-10-17,2022-10-19,ACTUAL,2020-04-24,ACTUAL,2020-04-24,2022-10,2022-10-31,2022-09-30,ACTUAL,2022-09-30,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,,,A Study of AK104 in Subjects With Locally Advanced Unresectable or Metastatic MSI-H/dMMR Solid Tumors,"A Single-arm, Open-label, Multicenter, Phase II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Subjects With Locally Advanced Unresectable or Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors",TERMINATED,,PHASE2,6.0,ACTUAL,Akeso,,1.0,,"Due to difficuty of erollment and consideration of clinical guideline,The sponsor decided to stop study.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2022,0.0
NCT03221634,,2017-07-17,,,2019-03-21,2017-07-17,2017-07-18,ACTUAL,,,,,,,2019-03-21,2019-03-25,ACTUAL,2017-08-01,ESTIMATED,2017-08-01,2019-03,2019-03-31,2021-06-10,ESTIMATED,2021-06-10,2019-03-20,ESTIMATED,2019-03-20,,INTERVENTIONAL,,,Efficacy and Safety Study of Pembrolizumab (MK-3475) in Combination With Daratumumab in Participants With Relapsed Refractory Multiple Myeloma (MK-3475-668/KEYNOTE-668),A Phase 2 Study of Pembrolizumab in Combination With Daratumumab (Anti CD38) in Participants With Relapsed Refractory Multiple Myeloma (rrMM),WITHDRAWN,,PHASE2,0.0,ACTUAL,Merck Sharp & Dohme LLC,,1.0,,Business Reasons,f,,,,f,t,f,,,,,,,,,,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2021,0.0
NCT06090318,,2022-11-14,,,2023-10-16,2023-10-16,2023-10-19,ACTUAL,,,,,,,2023-10-16,2023-10-19,ACTUAL,2023-05-19,ACTUAL,2023-05-19,2023-10,2023-10-31,2023-05-30,ACTUAL,2023-05-30,2023-05-30,ACTUAL,2023-05-30,,INTERVENTIONAL,,,Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss,A Phase 1b/2Study of Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss (MANTRA-4),WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Rain Oncology Inc,,1.0,,Sponsor Decision,f,,,,,t,f,,,,,,,,,,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2023,0.0
NCT03635047,,2018-08-15,,,2020-12-07,2018-08-15,2018-08-17,ACTUAL,,,,,,,2020-12-07,2020-12-09,ACTUAL,2018-11-12,ACTUAL,2018-11-12,2020-12,2020-12-31,2020-11-25,ACTUAL,2020-11-25,2020-08-03,ACTUAL,2020-08-03,,INTERVENTIONAL,,,A Phase I Study for Safety and Tolerability of AL002.,"A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Doses of AL002 in Healthy Participants and in Participants With Mild to Moderate Alzheimer's Disease",COMPLETED,,PHASE1,69.0,ACTUAL,Alector Inc.,,2.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2020,1.0
NCT04501679,,2020-07-30,2024-05-16,2023-03-29,2024-07-04,2020-08-05,2020-08-06,ACTUAL,2024-07-04,2024-07-10,ACTUAL,,2024-07-10,ACTUAL,2024-07-04,2024-07-10,ACTUAL,2020-08-11,ACTUAL,2020-08-11,2024-07,2024-07-31,2022-03-31,ACTUAL,2022-03-31,2022-03-30,ACTUAL,2022-03-30,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all randomized participants.,A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN),"A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis",COMPLETED,,PHASE3,274.0,ACTUAL,Galderma R&D,,2.0,,,f,,,,t,t,f,,,,,,Data availability will begin 6 months after approval of the indication by a regulatory body.~Data availability will end 5 years from publication of the primary study results article.,Data will be made available to qualified science and medical researchers upon formal request and submission of research proposal detailing planned analyses. Proposals should be directed to clinical.studies@galderma.com,,YES,Qualified researchers may request access to anonymized data sets from which results presented are derived.,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,INDUSTRY,,,,,,,2022,1.0
NCT04081597,,2019-09-05,,,2020-02-12,2019-09-05,2019-09-09,ACTUAL,,,,,,,2020-02-12,2020-02-13,ACTUAL,2020-02,ESTIMATED,2020-02-29,2019-11,2019-11-30,2020-03,ESTIMATED,2020-03-31,2020-03,ESTIMATED,2020-03-31,,INTERVENTIONAL,,,A Study of Single Ascending Doses of STAR-101 in Healthy Participants,"A Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Doses of STAR-101 in Healthy Subjects",WITHDRAWN,,PHASE1,0.0,ACTUAL,Acanthas Pharma Inc,,2.0,,Change in Clinical Strategy,f,,,,t,f,f,,,,,,,,,,,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,INDUSTRY,,,,,,,2020,0.0
NCT06281236,,2024-02-20,,,2024-06-17,2024-02-20,2024-02-28,ACTUAL,,,,,,,2024-06-17,2024-06-20,ACTUAL,2024-02-22,ACTUAL,2024-02-22,2024-06,2024-06-30,2024-10-01,ESTIMATED,2024-10-01,2024-10-01,ESTIMATED,2024-10-01,,INTERVENTIONAL,,,A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR),A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR),SUSPENDED,,PHASE1,24.0,ESTIMATED,Sparrow Pharmaceuticals,,1.0,,Change of corporate priorities,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,INDUSTRY,,,,,,,2024,0.0
NCT05082493,,2021-09-22,,,2024-06-03,2021-10-04,2021-10-19,ACTUAL,,,,,,,2024-06-03,2024-06-06,ACTUAL,2023-12,ESTIMATED,2023-12-31,2024-06,2024-06-30,2023-12-30,ACTUAL,2023-12-30,2023-12-30,ACTUAL,2023-12-30,,INTERVENTIONAL,,,"A Multicenter, Study of the Safety and Pharmacokinetics of Intravenously Infused Berubicin in Pediatric Patients With Progressive, Refractory, or Recurrent High Grade Gliomas","A Phase 1, Multicenter, Open-label, Dose Escalation Study of the Safety and Pharmacokinetics of Intravenously Infused Berubicin in Pediatric Patients With Progressive, Refractory, or Recurrent High Grade Gliomas",WITHDRAWN,,PHASE1,0.0,ACTUAL,WPD Pharmaceuticals Sp. z o.o.,,1.0,,Business decision,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2023,0.0
NCT05071183,,2021-09-13,2024-01-29,,2024-03-08,2021-10-06,2021-10-08,ACTUAL,2024-03-08,2024-04-02,ACTUAL,,,,2024-03-08,2024-04-02,ACTUAL,2021-09-23,ACTUAL,2021-09-23,2024-03,2024-03-31,2023-03-01,ACTUAL,2023-03-01,2023-03-01,ACTUAL,2023-03-01,,INTERVENTIONAL,,,A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors,A Phase 1b/2 Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Advanced Solid Tumors (TRIDENT-2),TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,"Turning Point Therapeutics, Inc.","Study terminated early by sponsor before initiation of phase 2, so phase 2 outcome measures and endpoint data will not be reported.",1.0,,Inability to achieve and optimize a dose that could provide a positive benefit risk profile,t,,,,f,t,f,,,,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,INDUSTRY,,NCT05926232,AVAILABLE,,,,2023,0.0
NCT05251376,,2022-01-20,,,2023-01-17,2022-02-11,2022-02-22,ACTUAL,,,,,,,2023-01-17,2023-01-19,ACTUAL,2022-02-28,ACTUAL,2022-02-28,2023-01,2023-01-31,2022-12-19,ACTUAL,2022-12-19,2022-12-19,ACTUAL,2022-12-19,,INTERVENTIONAL,,,Study of LYN-014 in Individuals With Opioid Use Disorder Who Are Stable on Methadone Therapy,"A Phase 1, Single Dose, Open-label, Safety, Tolerability, and Pharmacokinetic Study of LYN-014 in Individuals With Opioid Use Disorder Who Are Stable on Methadone Therapy",WITHDRAWN,,PHASE1,0.0,ACTUAL,Lyndra Inc.,,1.0,,Sponsor decision.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,INDUSTRY,,,,,,,2022,0.0
NCT04570657,,2020-08-07,2023-12-12,,2024-01-09,2020-09-25,2020-09-30,ACTUAL,2024-01-09,2024-01-30,ACTUAL,,,,2024-01-09,2024-01-30,ACTUAL,2020-09-17,ACTUAL,2020-09-17,2024-01,2024-01-31,2023-02-06,ACTUAL,2023-02-06,2022-12-12,ACTUAL,2022-12-12,,INTERVENTIONAL,FRONTIER-3,,Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma,"A Phase II, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MEDI3506 in Adult Participants With Uncontrolled Moderate-to-severe Asthma",COMPLETED,,PHASE2,250.0,ACTUAL,AstraZeneca,"15 participants enrolled at 1 study centre were excluded from the final analysis due to inability to confirm the validity of the data reported by the site. The exclusion of data from this site did not change the interpretation of the primary endpoint, or results in a significant change to the interpretation of any other endpoint.",3.0,,,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,INDUSTRY,,,,,,,2023,1.0
NCT03920631,,2019-04-08,,,2021-03-19,2019-04-17,2019-04-19,ACTUAL,,,,,,,2021-03-19,2021-03-23,ACTUAL,2020-07-10,ESTIMATED,2020-07-10,2021-03,2021-03-31,2023-05-15,ESTIMATED,2023-05-15,2023-03-15,ESTIMATED,2023-03-15,,INTERVENTIONAL,MicroBLITZ,,Microtransplantation and Checkpoint Blockade Immunotherapy for Relapsed or Refractory B Cell Lymphomas,MicroBLITZ: Microtransplantation and Checkpoint Blockade Immunotherapy for Relapsed or Refractory B Cell Lymphomas,WITHDRAWN,,PHASE1,0.0,ACTUAL,Duke University,,4.0,,Lack of accrual,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,OTHER,,,,,,,2023,0.0
NCT02953379,,2016-11-01,,,2020-11-03,2016-11-01,2016-11-02,ESTIMATED,,,,,,,2020-11-03,2020-11-04,ACTUAL,2019-05,ESTIMATED,2019-05-31,2020-11,2020-11-30,2020-03,ESTIMATED,2020-03-31,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis,"Phase III, National, Multicenter, Randomized, Single-blind, Non-inferiority to Compare the Efficacy of Mometasone Nasal Gel Compared to Mometasone Nasal Spray in the Treatment of Persistent or Intermittent Allergic Rhinitis in Adults",WITHDRAWN,,PHASE3,0.0,ACTUAL,EMS,,2.0,,Sponsor decision,f,,,,t,f,f,,,,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,INDUSTRY,,,,,,,2020,0.0
NCT05692154,,2023-01-11,2024-03-12,,2024-04-23,2023-01-11,2023-01-20,ACTUAL,2024-04-23,2024-05-16,ACTUAL,,,,2024-04-23,2024-05-16,ACTUAL,2023-01-23,ACTUAL,2023-01-23,2024-04,2024-04-30,2023-03-14,ACTUAL,2023-03-14,2023-03-14,ACTUAL,2023-03-14,,INTERVENTIONAL,FEXPRESAR,"The mITT analysis set contained all eligible, ITT, and treated participants with Total Nasal Symptom Score of 3 symptoms (TNSS-3) evaluation Hour 0 (H0) at visit 4 (V4) and at least a further time point at Visit 4.",A Placebo-controlled Study of 2-day Pre-treatment With Fexofenadine in Seasonal Allergic Rhinitis,"A Phase IIIb, Single-center, Double-blind, Two-arms, Placebo-controlled, Randomized, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of 2-day Pre-treatment With Fexofenadine in Patients Suffering From Seasonal Allergic Rhinitis",COMPLETED,,PHASE3,95.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,INDUSTRY,,,,,,,2023,1.0
NCT05499416,,2022-08-03,,,2023-03-13,2022-08-10,2022-08-12,ACTUAL,,,,,,,2023-03-13,2023-03-15,ACTUAL,2023-01,ESTIMATED,2023-01-31,2023-03,2023-03-31,2024-04,ESTIMATED,2024-04-30,2023-09,ESTIMATED,2023-09-30,,INTERVENTIONAL,,,Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis,Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis Who Have an Inadequate Skin Response to Anti-IL23 Therapy,WITHDRAWN,,PHASE4,0.0,ACTUAL,Innovaderm Research Inc.,,1.0,,Sponsor decision.,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,OTHER,,,,,,,2024,0.0
NCT01718756,,2012-10-28,,,2020-09-02,2012-10-30,2012-10-31,ESTIMATED,,,,,,,2020-09-02,2020-09-04,ACTUAL,2013-06,ACTUAL,2013-06-30,2020-09,2020-09-30,2022-02,ESTIMATED,2022-02-28,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Continuous Lornoxicam Infusion for Orthopaedic Surgery,Efficacy of Continuous Intravenous Infusion vs. Scheduled Dosing of Lornoxicam on Patient Controlled Morphine Consumption After Orthopaedic Surgery: A Comparative Placebo Study,SUSPENDED,,PHASE1/PHASE2,96.0,ESTIMATED,Mansoura University,,3.0,,No enough fund or cases,f,,,,t,,,,,,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,OTHER,,,,,,,2022,0.0
NCT05040789,,2021-08-26,,,2023-05-31,2021-09-08,2021-09-10,ACTUAL,,,,,,,2023-05-31,2023-06-02,ACTUAL,2021-11-22,ESTIMATED,2021-11-22,2023-05,2023-05-31,2022-05-31,ESTIMATED,2022-05-31,2022-05-31,ESTIMATED,2022-05-31,,INTERVENTIONAL,,,Phase 3 Study to Evaluate the Lot Consistency of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine,"A Randomized, Observer-Blind, Multicenter, Phase 3 Study to Evaluate the Lot Consistency of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults 18-49 Years of Age",WITHDRAWN,,PHASE3,0.0,ACTUAL,Medicago,,3.0,,Further development terminated,f,,,,f,t,f,,,,,,,,,,,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,INDUSTRY,,,,,,,2022,0.0
NCT04105998,,2019-09-24,2022-10-14,,2022-10-14,2019-09-24,2019-09-26,ACTUAL,2022-10-14,2022-11-10,ACTUAL,,,,2022-10-14,2022-11-10,ACTUAL,2019-10-24,ACTUAL,2019-10-24,2021-11,2021-11-30,2021-11-01,ACTUAL,2021-11-01,2021-11-01,ACTUAL,2021-11-01,,INTERVENTIONAL,,,Effects of Intramuscular (IM) Oxytocin on Pupil Diameter and Heart Rate Variability (HRV),Effects of Intramuscular Oxytocin on Pupil Diameter and Heart Rate Variability,COMPLETED,,PHASE4,22.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,OTHER,,,,,,,2021,1.0
NCT03154827,,2017-05-14,2024-08-14,,2024-08-14,2017-05-14,2017-05-16,ACTUAL,2024-08-14,2024-09-05,ACTUAL,,,,2024-08-14,2024-09-05,ACTUAL,2018-01-08,ACTUAL,2018-01-08,2024-08,2024-08-31,2020-04-01,ACTUAL,2020-04-01,2020-04-01,ACTUAL,2020-04-01,,INTERVENTIONAL,,All patients who were eligible to the study,"Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myeloid Leukemia (AML)","An Open-Label, Single Arm, Study, To Evaluate the Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab Combination for Maintenance Treatment in Subjects With Acute Myeloid Leukemia Who Are 60 Years or Older - The BATTLE Study",TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,"BioLineRx, Ltd.",,1.0,,Due to lack of enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2020,0.0
NCT03818165,,2019-01-23,,,2023-01-12,2019-01-23,2019-01-28,ACTUAL,,,,,,,2023-01-12,2023-01-17,ACTUAL,2019-07-29,ACTUAL,2019-07-29,2023-01,2023-01-31,2021-05-21,ACTUAL,2021-05-21,2020-01-19,ACTUAL,2020-01-19,,INTERVENTIONAL,AntiCEA_CART,,Phase 1b Study of CAR2Anti-CEA CAR-T Cell Hepatic Infusions for Pancreatic Carcinoma Patients With CEA+ Liver Metastases,Phase 1b Study of the Efficacy and Safety of CAR2 Anti-CEA CAR-T Cell Hepatic Infusions for Pancreatic Carcinoma Patients With CEA+ Liver Metastases Resistant to Standard Therapy Using the HITM Method and Pressure Enabled Delivery Device,TERMINATED,,PHASE1,2.0,ACTUAL,"Sorrento Therapeutics, Inc.",,1.0,,Limited enrollment.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,INDUSTRY,,,,,,,2021,0.0
NCT05124795,,2021-10-29,,,2024-01-15,2021-11-15,2021-11-18,ACTUAL,,,,,,,2024-01-15,2024-01-17,ACTUAL,2021-12-09,ACTUAL,2021-12-09,2024-01,2024-01-31,2023-05-31,ACTUAL,2023-05-31,2023-05-31,ACTUAL,2023-05-31,,INTERVENTIONAL,,,"IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer","Dose Escalation Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Single Agent IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer",TERMINATED,,PHASE1,18.0,ACTUAL,Immunic AG,,3.0,,Lack of Efficacy,f,,,,t,f,f,,,,,,,,,,,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,INDUSTRY,,,,,,,2023,0.0
NCT02927873,,2016-10-06,2021-09-28,2020-01-27,2021-09-28,2016-10-06,2016-10-07,ESTIMATED,2021-09-28,2021-10-28,ACTUAL,2020-01-27,2020-02-06,ACTUAL,2021-09-28,2021-10-28,ACTUAL,2017-01-11,ACTUAL,2017-01-11,2021-09,2021-09-30,2020-11-26,ACTUAL,2020-11-26,2019-02-19,ACTUAL,2019-02-19,,INTERVENTIONAL,,,"A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants","A Phase 1/2, Randomized, Observer-blind, Controlled, Multi-center, Dose-escalation Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine Based on the RSV Viral Proteins F, N and M2-1 Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A), When Administered Intramuscularly According to a 0, 1-month Schedule to RSV-seropositive Infants Aged 12 to 23 Months",COMPLETED,,PHASE1/PHASE2,107.0,ACTUAL,GlaxoSmithKline,,6.0,,,f,,,,,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",https://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,INDUSTRY,,,,,,,2020,1.0
NCT02073279,,2014-02-25,2020-09-11,2019-06-05,2023-01-31,2014-02-25,2014-02-27,ESTIMATED,2020-12-07,2020-12-31,ACTUAL,2019-06-05,2019-06-07,ACTUAL,2023-01-31,2023-03-01,ACTUAL,2014-08-05,ACTUAL,2014-08-05,2023-01,2023-01-31,2022-01-31,ACTUAL,2022-01-31,2018-10-12,ACTUAL,2018-10-12,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all participants randomized to the treatment groups.,Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD),"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)",COMPLETED,,PHASE3,95.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,INDUSTRY,,,,,,,2022,1.0
NCT03640754,,2018-07-30,2023-05-31,,2023-11-03,2018-08-20,2018-08-21,ACTUAL,2023-11-03,2023-11-28,ACTUAL,,,,2023-11-03,2023-11-28,ACTUAL,2018-08-06,ACTUAL,2018-08-06,2023-11,2023-11-30,2022-02-22,ACTUAL,2022-02-22,2022-01-21,ACTUAL,2022-01-21,,INTERVENTIONAL,,,A Study of the Safety and Effect of Repeated Administration of G-CSF on Hot Flashes in Postmenopausal Women,Study to Assess the Safety and Effect of Repeated Administration of Granulocyte Colony-Stimulating Factor (G-CSF; Filgrastim) on Hot Flashes and Other Vasomotor Symptoms of Menopause in Postmenopausal Women,COMPLETED,,PHASE1,61.0,ACTUAL,"MenoGeniX, Inc.",,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2022,1.0
NCT05066230,,2021-09-23,2024-07-16,,2024-08-30,2021-09-23,2021-10-04,ACTUAL,2024-08-30,2024-09-05,ACTUAL,,,,2024-08-30,2024-09-05,ACTUAL,2021-09-07,ACTUAL,2021-09-07,2024-08,2024-08-31,2023-08-31,ACTUAL,2023-08-31,2023-08-03,ACTUAL,2023-08-03,,INTERVENTIONAL,GLOW,Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment.,A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR),"A Prospective, Randomized, Double-masked, Sham-controlled, Multicenter, Two-arm Phase3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy",TERMINATED,,PHASE3,253.0,ACTUAL,Kodiak Sciences Inc,,2.0,,All patients completed the primary endpoint assessments. Additional follow-up after the primary endpoint was deemed not necessary by the Sponsor.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2023,0.0
NCT04417907,,2020-06-02,2024-04-15,,2024-05-08,2020-06-02,2020-06-05,ACTUAL,2024-05-08,2024-06-06,ACTUAL,,,,2024-05-08,2024-06-06,ACTUAL,2021-10-20,ACTUAL,2021-10-20,2024-05,2024-05-31,2023-05-01,ACTUAL,2023-05-01,2023-05-01,ACTUAL,2023-05-01,,INTERVENTIONAL,,,Perampanel Titration and Cognitive Effects,Effects of Titration Rate on Cognitive and Behavioral Side Effects of Perampanel,TERMINATED,,PHASE4,29.0,ACTUAL,Stanford University,"Enrollment was delayed due to the COVID-19 pandemic. The sponsor then decided to no longer fund the study. These caused total enrollment to be low, preventing statistical analyses from being conducted.",4.0,,Study sponsor no longer provided funding.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,OTHER,,,,,,,2023,0.0
NCT04551573,,2020-09-09,,,2021-09-13,2020-09-09,2020-09-16,ACTUAL,,,,,,,2021-09-13,2021-09-20,ACTUAL,2021-05,ESTIMATED,2021-05-31,2021-09,2021-09-30,2021-11,ESTIMATED,2021-11-30,2021-10,ESTIMATED,2021-10-31,,INTERVENTIONAL,,,"A Study of the Pharmacokinetic and Pharmacodynamic Interactions Between Bictegravir, Tenofovir Alafenamide and Rifapentine in Healthy Adult Subjects","A Study of the Pharmacokinetic and Pharmacodynamic Interactions Between Bictegravir, Tenofovir Alafenamide and Rifapentine in Healthy Adult Subjects",WITHDRAWN,,PHASE4,0.0,ACTUAL,Yale University,,2.0,,COVID-19 Pandemic,f,,,,t,t,f,,,f,,,,,,YES,,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,OTHER,,,,,,,2021,0.0
NCT02293655,,2014-10-29,2021-11-30,,2023-11-27,2014-11-14,2014-11-18,ESTIMATED,2022-01-07,2022-02-04,ACTUAL,,,,2023-11-27,2023-12-21,ACTUAL,2015-01-12,ACTUAL,2015-01-12,2023-11,2023-11-30,2021-06-30,ACTUAL,2021-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,TEAM,,The Effects of ADHD Medication (TEAM) Study,The Effects of ADHD Medication (TEAM) Study: Neurobehavioral Effects of Abrupt Methylphenidate Discontinuation,COMPLETED,,PHASE4,204.0,ACTUAL,"Children's Hospital Medical Center, Cincinnati",Note that the school direct observations outcome was not collected due to data collection not being feasible due to schools' privacy concerns about other students in the classroom. All other outcome measures that were pre-specified Primary or Secondary Outcome Measures have been reported in this ClinicalTrials.gov entry.,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,OTHER,,,,,,,2021,1.0
NCT03740919,,2018-11-12,2021-12-23,,2021-12-23,2018-11-12,2018-11-14,ACTUAL,2021-12-23,2022-01-24,ACTUAL,,,,2021-12-23,2022-01-24,ACTUAL,2019-04-07,ACTUAL,2019-04-07,2021-12,2021-12-31,2021-07-02,ACTUAL,2021-07-02,2021-07-02,ACTUAL,2021-07-02,,INTERVENTIONAL,PRONTO-Peds,All participants who were randomly assigned to study treatment..,A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes,"A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog With an Open-Label Postprandial LY900014 Treatment Group in Children and Adolescents With Type 1 Diabetes",COMPLETED,,PHASE3,751.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2021,1.0
NCT03619876,,2018-08-03,2023-04-14,,2023-04-14,2018-08-03,2018-08-08,ACTUAL,2023-04-14,2023-05-08,ACTUAL,,,,2023-04-14,2023-05-08,ACTUAL,2019-07-10,ACTUAL,2019-07-10,2023-04,2023-04-30,2021-09-15,ACTUAL,2021-09-15,2021-09-15,ACTUAL,2021-09-15,,INTERVENTIONAL,AMiRA,"Of the four participants that started in the Non-TNF inhibitor arm, three were included in baseline analysis as one participant withdrew. Of the six participants that started in the TNF inhibitor arm, four were included in baseline analysis, as two participants withdrew.",Effects of Abatacept on Myocarditis in Rheumatoid Arthritis,Effects of Abatacept on Myocarditis in Rheumatoid Arthritis,TERMINATED,,PHASE4,11.0,ACTUAL,Columbia University,,2.0,,Lack of funding,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,OTHER,,,,,,,2021,0.0
NCT04385849,,2020-05-07,2024-04-02,,2024-08-27,2020-05-12,2020-05-13,ACTUAL,2024-08-27,2024-09-05,ACTUAL,,,,2024-08-27,2024-09-05,ACTUAL,2020-07-22,ACTUAL,2020-07-22,2021-08,2021-08-31,2020-07-25,ACTUAL,2020-07-25,2020-07-25,ACTUAL,2020-07-25,,INTERVENTIONAL,,No subjects were enrolled in the Placebo arm.,Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19,"Phase 1b, Randomized, Blinded, Placebo-controlled Study of the Safety of Therapeutic Treatment With an Immunomodulary Agent (N-803 in Adults With COVID-19",TERMINATED,,PHASE1,1.0,ACTUAL,"ImmunityBio, Inc.",The study is terminated early due to low enrollment. Effect of the study drug on efficacy was not analyzed.,2.0,,Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2020,0.0
NCT04049578,,2019-08-06,2020-09-21,,2020-09-21,2019-08-06,2019-08-08,ACTUAL,2020-09-21,2020-10-14,ACTUAL,,,,2020-09-21,2020-10-14,ACTUAL,2019-12-19,ACTUAL,2019-12-19,2020-09,2020-09-30,2020-05-06,ACTUAL,2020-05-06,2020-04-23,ACTUAL,2020-04-23,,INTERVENTIONAL,,,"A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children With Autism Spectrum Disorder","A Phase Ib, Multicenter, Open-Label, 6-Week Study With a 48-Week Extension to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children Ages 2-4 Years With Autism Spectrum Disorder",TERMINATED,,PHASE1,2.0,ACTUAL,Hoffmann-La Roche,Study was terminated with 2 participants enrolled. Due to low enrollment number patient analysis are not provided to protect participant confidentiality.,1.0,,Recent analysis of Phase II balovaptan data in paediatric ASD did not support the continuation of this study. No new safety concerns were identified.,f,,,,,t,f,,,,,,,,,NO,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2020,0.0
NCT03191526,,2017-06-13,,,2022-04-06,2017-06-14,2017-06-19,ACTUAL,,,,,,,2022-04-06,2022-04-14,ACTUAL,2017-05-22,ACTUAL,2017-05-22,2022-04,2022-04-30,2021-08-31,ACTUAL,2021-08-31,2019-06-06,ACTUAL,2019-06-06,,INTERVENTIONAL,,,A Study of KW-0761 in Subjects With HTLV-1 Associated Myelopathy (HAM),"A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Patients With HTLV-1 Associated Myelopathy (HAM)",TERMINATED,,PHASE3,66.0,ACTUAL,"Kyowa Kirin Co., Ltd.",,2.0,,Due to not achieving the primary outcome.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2021,0.0
NCT04327999,,2020-03-04,2023-11-18,,2024-01-12,2020-03-28,2020-03-31,ACTUAL,2024-01-12,2024-01-18,ACTUAL,,,,2024-01-12,2024-01-18,ACTUAL,2020-10-05,ACTUAL,2020-10-05,2024-01,2024-01-31,2023-09-25,ACTUAL,2023-09-25,2023-09-25,ACTUAL,2023-09-25,,INTERVENTIONAL,,,Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System,Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System of Patients Following Radioiodine Therapy for Thyroid Carcinoma,TERMINATED,,PHASE2,9.0,ACTUAL,Vanderbilt-Ingram Cancer Center,,1.0,,Funding ended,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,OTHER,,,,,,,2023,0.0
NCT04794790,,2021-03-01,,,2024-05-21,2021-03-08,2021-03-12,ACTUAL,,,,,,,2024-05-21,2024-05-22,ACTUAL,2022-05-09,ACTUAL,2022-05-09,2024-05,2024-05-31,2024-06-22,ESTIMATED,2024-06-22,2024-02-22,ESTIMATED,2024-02-22,,INTERVENTIONAL,,,Buprenorphine Induction for Fentanyl Dependent Opioid Users,Pilot Study to Look at Feasibility of Testing and Treatment of Combination Fentanyl and Opioid Dependent Individuals With Different Buprenorphine Induction Methods,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Milton S. Hershey Medical Center,,3.0,,Unable to enroll--patients uninterested in trying buprenorphine.,f,,,,f,t,f,,,f,,,,,,UNDECIDED,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,OTHER,,,,,,,2024,0.0
NCT05126927,,2021-11-01,,,2023-04-10,2021-11-08,2021-11-19,ACTUAL,,,,,,,2023-04-10,2023-04-12,ACTUAL,2021-11-02,ACTUAL,2021-11-02,2023-04,2023-04-30,2022-08-01,ACTUAL,2022-08-01,2022-01-19,ACTUAL,2022-01-19,,INTERVENTIONAL,,,A PET Imaging Agent to Assess the Level of Tumor Tissue-infiltrating CD8 + T Cells in Patients With Solid Tumors,"A Study to Evaluate the Safety Tolerability, Radiation Absorbed Dose,Distribution, PET Imaging and Histological Expression of 68GA-Nodaga-SNA006 in Patients With Solid Tumors.",COMPLETED,,EARLY_PHASE1,11.0,ACTUAL,SmartNuclide Biopharma,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,INDUSTRY,,,,,,,2022,1.0
NCT04422210,,2020-06-05,2021-10-08,,2021-10-08,2020-06-05,2020-06-09,ACTUAL,2021-10-08,2021-11-08,ACTUAL,,,,2021-10-08,2021-11-08,ACTUAL,2020-09-22,ACTUAL,2020-09-22,2021-10,2021-10-31,2020-11-06,ACTUAL,2020-11-06,2020-11-06,ACTUAL,2020-11-06,,INTERVENTIONAL,,"The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.","A Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Participants With Untreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC).","A Phase Ib Dose-Escalation and Dose-Expansion Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Patients With Untreated Extensive-Stage Small Cell Lung Cancer.",TERMINATED,,PHASE1,2.0,ACTUAL,Hoffmann-La Roche,"The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.",8.0,,Decision to discontinue the study based on broader development and strategic prioritisation. The Sponsor concludes there is no benefit-risk impact on the GO41864 study.,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2020,0.0
NCT03917719,,2019-04-12,,,2020-11-19,2019-04-16,2019-04-17,ACTUAL,,,,,,,2020-11-19,2020-11-23,ACTUAL,2019-03-14,ACTUAL,2019-03-14,2020-11,2020-11-30,2020-10-26,ACTUAL,2020-10-26,2020-10-26,ACTUAL,2020-10-26,,INTERVENTIONAL,GalaxyDMD,,An Open-Label Extension Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy,An Open-Label Extension Study of Edasalonexent in Pediatric Patients With Duchenne Muscular Dystrophy,TERMINATED,,PHASE3,130.0,ACTUAL,Catabasis Pharmaceuticals,,1.0,,"The Phase 3 PolarisDMD trial did not meet the primary endpoint. As a result, activities related to the development of edasalonexent have stopped including the CAT-1004-302 Open-Label Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy",f,,,,t,t,f,,,,,,,,,,,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,INDUSTRY,,,,,,,2020,0.0
NCT01996098,,2013-11-21,,,2024-09-01,2013-11-21,2013-11-27,ESTIMATED,,,,,,,2024-09-01,2024-09-05,ACTUAL,2014-01-01,ACTUAL,2014-01-01,2024-09,2024-09-30,2024-02-15,ACTUAL,2024-02-15,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,ICTAN,,Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation,"A Multicenter, Randomized, Phase III Trial of Chemotherapy Followed by 6-month or 12-month Icotinib Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA Non-small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutation",TERMINATED,,PHASE3,251.0,ACTUAL,Sun Yat-sen University,,3.0,,Slow accural.,f,,,,t,,,,,,,,,,,,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,OTHER,,,,,,,2024,0.0
NCT05610254,,2022-11-02,,,2024-09-02,2022-11-02,2022-11-09,ACTUAL,,,,,,,2024-09-02,2024-09-05,ACTUAL,2022-10-24,ACTUAL,2022-10-24,2024-09,2024-09-30,2022-12-03,ACTUAL,2022-12-03,2022-12-03,ACTUAL,2022-12-03,,INTERVENTIONAL,,,The Cold Fluids Study,Rapid Infusion of Ringer's Lactate Solution At Different Temperatures and the Effects on Circulation and Perfusion in Healthy Volunteers - a Randomized Crossover Trial,COMPLETED,,PHASE4,18.0,ACTUAL,Esbjerg Hospital - University Hospital of Southern Denmark,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,OTHER,,,,,,,2022,1.0
NCT05653427,,2022-12-08,,,2023-12-06,2022-12-08,2022-12-16,ACTUAL,,,,,,,2023-12-06,2023-12-07,ACTUAL,2022-12-08,ACTUAL,2022-12-08,2023-12,2023-12-31,2023-10-10,ACTUAL,2023-10-10,2023-10-10,ACTUAL,2023-10-10,,INTERVENTIONAL,,,A Study of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma,"A Phase 2, Open-Label Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma",TERMINATED,,PHASE2,18.0,ACTUAL,"Janssen Research & Development, LLC",,1.0,,N\~15 subjects data analysis did not meet statistical consideration of ORR and study primary/secondary objectives were not met. Enrollment was terminated for futility,f,,,,f,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,INDUSTRY,,,,,,,2023,0.0
NCT03419806,,2018-01-10,,,2020-11-04,2018-01-26,2018-02-05,ACTUAL,,,,,,,2020-11-04,2020-11-05,ACTUAL,2018-02-16,ACTUAL,2018-02-16,2020-11,2020-11-30,2020-04-20,ACTUAL,2020-04-20,2020-03-27,ACTUAL,2020-03-27,,INTERVENTIONAL,IPO-001,,Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa in Patients With Parkinson's Disease,"Levodopa Pharmacokinetics in Patients With Parkinson's Disease and Symptom Fluctuation: A Phase I, Open-label, Randomized, Multicentre, Crossover Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa",COMPLETED,,PHASE1,25.0,ACTUAL,Vastra Gotaland Region,,3.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,OTHER_GOV,,,,,,,2020,1.0
NCT03739476,,2018-10-18,,,2022-06-10,2018-11-09,2018-11-13,ACTUAL,,,,,,,2022-06-10,2022-06-14,ACTUAL,2019-02-13,ACTUAL,2019-02-13,2022-06,2022-06-30,2020-06-30,ACTUAL,2020-06-30,2020-04-02,ACTUAL,2020-04-02,,INTERVENTIONAL,,,Clinical Trial With Quetiapine Prophylaxis Postoperative Delirium in High Risk Surgical Patients,"Controlled, Double-blind, Randomized Clinical Trial for Prophylaxis of Postoperative Delirium in High Risk Surgical Patients With Quetiapine",TERMINATED,,PHASE3,50.0,ACTUAL,Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León,,2.0,,"Due to the crisis SARS-COV-2 pandemic: recruitment of patients for the trial is stopped, healthcare pressure generated, suspend the non-essential scheduled surgical activity and on June 30, 2020 medication expired, funding has been exhausted.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,OTHER,,,,,,,2020,0.0
NCT03979638,,2019-06-06,2021-07-05,,2021-07-31,2019-06-06,2019-06-07,ACTUAL,2021-07-31,2021-08-03,ACTUAL,,,,2021-07-31,2021-08-03,ACTUAL,2019-07-10,ACTUAL,2019-07-10,2020-04,2020-04-30,2020-04-23,ACTUAL,2020-04-23,2020-04-23,ACTUAL,2020-04-23,,INTERVENTIONAL,RELIEF,The baseline analysis population consisted of all randomized participants who have received at least 1 dose of study drug.,A Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough,"A Randomized, Double-Blind, Placebo-Controlled, Crossover, Dose Escalation Study of BLU-5937 in Subjects With Unexplained or Refractory Chronic Cough (RELIEF)",TERMINATED,,PHASE2,68.0,ACTUAL,Bellus Health Inc. - a GSK company,,2.0,,Trial was terminated due to the impact of the COVID-19 on trial activities. 68 patients with refractory chronic cough were enrolled with 52 completing treatment,f,,,,f,t,f,,,,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,INDUSTRY,,,,,,,2020,0.0
NCT03871517,,2019-03-04,,,2023-01-05,2019-03-11,2019-03-12,ACTUAL,,,,,,,2023-01-05,2023-01-09,ACTUAL,2019-06-03,ACTUAL,2019-06-03,2023-01,2023-01-31,2022-12-01,ACTUAL,2022-12-01,2022-03-01,ACTUAL,2022-03-01,,INTERVENTIONAL,,,"INdobufen Versus aSpirin in acUte Ischemic stRokE,INSURE","INdobufen Versus aSpirin in acUte Ischemic stRokE,INSURE",COMPLETED,,PHASE4,5438.0,ACTUAL,Beijing Tiantan Hospital,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,OTHER,,,,,,,2022,1.0
NCT03745196,,2018-10-24,,,2020-06-10,2018-11-14,2018-11-19,ACTUAL,,,,,,,2020-06-10,2020-06-12,ACTUAL,2018-11-15,ACTUAL,2018-11-15,2020-06,2020-06-30,2020-06-01,ACTUAL,2020-06-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,,,The Effect of PC945 on Aspergillus or Candida Lung Infections in Patients With Asthma or Chronic Respiratory Diseases,"A Double-blind, Placebo-controlled Study to Assess the Effects of Inhaled PC945 in the Treatment of Culture-positive Aspergillus or Candida Fungal Bronchitis in Subjects With Moderate to Severe Asthma or Other Chronic Respiratory Diseases.",TERMINATED,,PHASE2,13.0,ACTUAL,Pulmocide Ltd,,2.0,,The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,INDUSTRY,,,,,,,2020,0.0
NCT03436433,,2018-02-12,2021-12-02,,2023-04-11,2018-02-12,2018-02-19,ACTUAL,2021-12-02,2021-12-30,ACTUAL,,,,2023-04-11,2023-04-13,ACTUAL,2019-01-31,ACTUAL,2019-01-31,2023-04,2023-04-30,2020-12-04,ACTUAL,2020-12-04,2020-12-04,ACTUAL,2020-12-04,,INTERVENTIONAL,,,Seizure Prophylaxis in Patients With Glioma or Brain Metastasis,Phase II Trial of Seizure Prophylaxis in Brain Tumor Patients Undergoing Neurosurgical Procedure,TERMINATED,,PHASE2,4.0,ACTUAL,Duke University,"This study was limited by the small sample size, and a dataset with a larger sample size should be used to further evaluate the impact of LCM, LEV, and no antiepileptic drugs on adverse events, ED visits and hospital readmissions in the future.",3.0,,Did not enroll as planned,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,OTHER,,,,,,,2020,0.0
NCT05120960,,2021-11-03,,,2024-04-15,2021-11-03,2021-11-16,ACTUAL,,,,,,,2024-04-15,2024-04-17,ACTUAL,2023-02-27,ACTUAL,2023-02-27,2024-04,2024-04-30,2024-04-12,ACTUAL,2024-04-12,2024-04-12,ACTUAL,2024-04-12,,INTERVENTIONAL,,,"A Phase 1a/1b Study to Determine the Recommended Phase 2 Dose, of Tepotinib in Participants With MET Alterations and Brain Tumors","A Phase 1a/1b Study to Determine the Recommended Phase 2 Dose, of Tepotinib in Participants With MET Alterations and Brain Tumors",WITHDRAWN,,PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,0 participant accrual,,,,,t,t,f,,,,,,,,,,,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,OTHER,,,,,,,2024,0.0
NCT03712371,,2018-10-15,,2021-12-10,2021-12-10,2018-10-18,2018-10-19,ACTUAL,,,,,,,2021-12-10,2021-12-15,ACTUAL,2019-01-16,ACTUAL,2019-01-16,2021-12,2021-12-31,2021-09-07,ACTUAL,2021-09-07,2020-07-02,ACTUAL,2020-07-02,,INTERVENTIONAL,,,Study of Chitosan for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients,Phase 1b/2 Study of Chitosan for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients,TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,Medical University of South Carolina,,1.0,,Interim study results were not favorable to continue with further enrollment.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,OTHER,,,,,,,2021,0.0
NCT03911336,,2019-04-08,,,2022-06-17,2019-04-08,2019-04-11,ACTUAL,,,,,,,2022-06-17,2022-06-21,ACTUAL,2023-01-01,ESTIMATED,2023-01-01,2022-06,2022-06-30,2023-01-01,ESTIMATED,2023-01-01,2023-01-01,ESTIMATED,2023-01-01,,INTERVENTIONAL,,,Harnessing Chronomodulation to Enhance Osteogenesis,Harnessing Chronomodulation to Enhance Osteogenesis - A Pilot Randomized Controlled Trial -,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Iowa,,3.0,,Decided not to proceed,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,OTHER,,,,,,,2023,0.0
NCT04736602,,2021-01-29,2023-05-18,,2024-02-22,2021-01-29,2021-02-03,ACTUAL,2024-02-22,2024-08-01,ACTUAL,,,,2024-02-22,2024-08-01,ACTUAL,2021-03-27,ACTUAL,2021-03-27,2024-02,2024-02-29,2022-09-03,ACTUAL,2022-09-03,2022-02-09,ACTUAL,2022-02-09,,INTERVENTIONAL,,Intention-To-Treat (ITT) population consisted of all participants who received at least 1 dose of study medication.,Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty.,"An Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of Triptorelin 3-month Formulation in Chinese Children With Central Precocious Puberty",COMPLETED,,PHASE3,32.0,ACTUAL,Ipsen,,1.0,,,f,,,,f,f,f,,,,,,"Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.","Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).",https://vivli.org/members/ourmembers/,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.~Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.",2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2022,1.0
NCT05744115,,2023-02-01,,,2023-02-15,2023-02-15,2023-02-24,ACTUAL,,,,,,,2023-02-15,2023-02-24,ACTUAL,2021-07-27,ACTUAL,2021-07-27,2023-02,2023-02-28,2022-04-14,ACTUAL,2022-04-14,2022-04-14,ACTUAL,2022-04-14,,INTERVENTIONAL,Ga68-PSMA-11,,Ga-68-PSMA-11 in Men With Prostate Cancer,Utility of Ga-68-PSMA-11 in Management of Prostate Cancer,TERMINATED,,PHASE3,38.0,ACTUAL,Harry S. Truman Memorial Veterans' Hospital,,1.0,,The investigational product was approved by the FDA (12/20/2021) and is now commercially available,f,,,,f,t,f,,,f,,,,,,YES,"A de-identified, anonymized dataset will be prepared to share with other VA investigators upon request",2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,FED,,,,,,,2022,0.0
NCT04148105,,2019-10-21,,,2024-05-29,2019-10-30,2019-11-01,ACTUAL,,,,,,,2024-05-29,2024-05-31,ACTUAL,2019-11-01,ACTUAL,2019-11-01,2024-05,2024-05-31,2023-05-26,ACTUAL,2023-05-26,2023-05-21,ACTUAL,2023-05-21,,INTERVENTIONAL,,,Cilostazol and Nimodipine Combined Therapy After Aneurysmal Subarachnoid Hemorrhage (aSAH),"Efficacy and Safety of Cilostazol-Nimodipine Combined Therapy on Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage (aSAH): A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial",TERMINATED,,PHASE4,19.0,ACTUAL,Ascension South East Michigan,,2.0,,Insufficient recruitment,f,,,,t,t,f,,,f,,,,,,YES,"All of the individual participant data collected during the trial, after deidentification will be made available following publication upon request at the discretion of the principal investigator.",2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,OTHER,,,,,,,2023,0.0
NCT04253236,,2020-01-21,2022-07-01,2022-03-16,2022-07-01,2020-01-31,2020-02-05,ACTUAL,2022-07-01,2022-07-28,ACTUAL,2022-03-16,2022-03-18,ACTUAL,2022-07-01,2022-07-28,ACTUAL,2020-08-11,ACTUAL,2020-08-11,2022-07,2022-07-31,2021-04-01,ACTUAL,2021-04-01,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,ASCEND-WAIHA,Safety Population: all participants who received at least one dose of study treatment. Only data for Cohort 1 is presented as study was terminated early prior to completion of dosing all participants in Cohort 1 and and Cohort 2 was not initiated.,To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA).,"A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients With Warm Autoimmune Hemolytic Anemia",TERMINATED,,PHASE2,5.0,ACTUAL,Immunovant Sciences GmbH,,2.0,,Sponsor decision,,,,,f,t,f,,,f,,,,,,,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,INDUSTRY,,,,,,,2021,0.0
NCT04944901,,2021-06-21,2022-08-15,,2023-09-22,2021-06-28,2021-06-30,ACTUAL,2023-09-22,2024-03-25,ACTUAL,,,,2023-09-22,2024-03-25,ACTUAL,2021-08-02,ACTUAL,2021-08-02,2023-09,2023-09-30,2022-03-03,ACTUAL,2022-03-03,2022-03-03,ACTUAL,2022-03-03,,INTERVENTIONAL,,,"28-Day Daily-dose Crossover Study of the Safety and Tolerability of SB-121 (Lactobacillus Reuteri With Sephadex® and Maltose) in Subjects, Ages 15 to 45 Years, Diagnosed With Autistic Disorder","Randomized, Double-blind, Placebo-controlled, 28-Day Daily-dose Crossover Study of the Safety and Tolerability of SB-121 (Lactobacillus Reuteri With Sephadex® and Maltose) in Subjects, Ages 15 to 45 Years, Diagnosed With Autistic Disorder",COMPLETED,,PHASE1,15.0,ACTUAL,"Scioto Biosciences, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,INDUSTRY,,,,,,,2022,1.0
NCT01742338,,2012-12-03,2024-01-19,,2024-03-12,2012-12-03,2012-12-05,ESTIMATED,2024-03-12,2024-04-10,ACTUAL,,,,2024-03-12,2024-04-10,ACTUAL,2012-05-03,ACTUAL,2012-05-03,2024-03,2024-03-31,2020-03-15,ACTUAL,2020-03-15,2020-03-15,ACTUAL,2020-03-15,,INTERVENTIONAL,DOSE,,Dose of Corticosteroids in COPD,Determining Optimal Dose of Corticosteroids in COPD Exacerbations: A Pilot Study,TERMINATED,,PHASE4,89.0,ACTUAL,"Rutgers, The State University of New Jersey",,2.0,,Lack of research staff to recruit participants,f,,,,f,,,,,,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,OTHER,,,,,,,2020,0.0
NCT03663283,,2018-09-04,2021-01-21,,2021-02-15,2018-09-06,2018-09-10,ACTUAL,2021-02-15,2021-02-21,ACTUAL,,,,2021-02-15,2021-02-21,ACTUAL,2018-10-29,ACTUAL,2018-10-29,2021-02,2021-02-28,2020-02-14,ACTUAL,2020-02-14,2020-02-14,ACTUAL,2020-02-14,,INTERVENTIONAL,,,Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty,Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty: A Single Blinded Prospective Randomized Control Trial,COMPLETED,,PHASE4,104.0,ACTUAL,Mayo Clinic,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,OTHER,,,,,,,2020,1.0
NCT03437200,,2018-02-06,,,2023-02-17,2018-02-12,2018-02-19,ACTUAL,,,,,,,2023-02-17,2023-02-21,ACTUAL,2019-01-17,ACTUAL,2019-01-17,2023-02,2023-02-28,2022-10-07,ACTUAL,2022-10-07,2022-10-07,ACTUAL,2022-10-07,,INTERVENTIONAL,CRUCIAL,,Combination of Chemoradiation With Immunotherapy in Inoperable œsophageal Cancer,Phase II Trial in Inoperable œsophageal Cancer Evaluating the Feasibility of the Combination of Definitive Chemoradiation With the Immune Checkpoint Blockers Nivolumab +/- Ipilimumab,TERMINATED,,PHASE2,8.0,ACTUAL,European Organisation for Research and Treatment of Cancer - EORTC,,2.0,,Poor accrual,f,,,,,f,f,,,,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,NETWORK,,,,,,,2022,0.0
NCT03373383,,2017-12-07,2021-01-28,,2023-12-15,2017-12-13,2017-12-14,ACTUAL,2021-03-16,2021-04-09,ACTUAL,,,,2023-12-15,2023-12-19,ACTUAL,2018-02-12,ACTUAL,2018-02-12,2023-12,2023-12-31,2020-01-30,ACTUAL,2020-01-30,2020-01-30,ACTUAL,2020-01-30,,INTERVENTIONAL,ARISE,Baseline characteristics refer to the Randomized Set (RS) consisting of all participants randomized into the study.,Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy,"A Randomized, Double-Blind, Placebo-Controlled, Dose Finding Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy",COMPLETED,,PHASE2,411.0,ACTUAL,UCB Pharma,,5.0,,,f,,,,t,t,f,,,,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",http://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,INDUSTRY,,,,,,,2020,1.0
NCT03614923,,2018-07-27,2021-12-20,,2022-01-20,2018-08-02,2018-08-03,ACTUAL,2022-01-20,2022-01-24,ACTUAL,,,,2022-01-20,2022-01-24,ACTUAL,2018-11-29,ACTUAL,2018-11-29,2021-08,2021-08-31,2020-10-26,ACTUAL,2020-10-26,2020-09-02,ACTUAL,2020-09-02,,INTERVENTIONAL,,,Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP),"A Phase 2, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Investigate Etokimab (ANB020) in Adult Subjects With Chronic Rhinosinusitis With Nasal Polyposis",COMPLETED,,PHASE2,105.0,ACTUAL,"AnaptysBio, Inc.",,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2020,1.0
NCT04254978,,2020-01-15,2024-03-06,,2024-03-06,2020-02-02,2020-02-05,ACTUAL,2024-03-06,2024-04-02,ACTUAL,,,,2024-03-06,2024-04-02,ACTUAL,2020-09-08,ACTUAL,2020-09-08,2024-03,2024-03-31,2023-03-23,ACTUAL,2023-03-23,2023-03-23,ACTUAL,2023-03-23,,INTERVENTIONAL,,,Study of Bomedemstat in Participants With Essential Thrombocythemia (IMG-7289-CTP-201/MK-3543-003),"A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy and Pharmacodynamics of IMG-7289 in Patients With Essential Thrombocythemia",COMPLETED,,PHASE2,73.0,ACTUAL,"Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)",,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,INDUSTRY,,,,,,,2023,1.0
NCT04761887,,2021-02-16,,,2022-10-14,2021-02-18,2021-02-21,ACTUAL,,,,,,,2022-10-14,2022-10-18,ACTUAL,2022-12,ESTIMATED,2022-12-31,2022-10,2022-10-31,2023-03,ESTIMATED,2023-03-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Cool Pre-operative TAP Blocks,Pilot Study on the Thermal Effects of Local Anesthetics,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Kentucky,,2.0,,Study withdrawn prior to enrollment (insufficient funds and reduced access to patients related to COVID protocols),f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,OTHER,,,,,,,2023,0.0
NCT04504032,,2020-08-05,2021-09-29,,2021-10-20,2020-08-05,2020-08-07,ACTUAL,2021-10-20,2021-10-22,ACTUAL,,,,2021-10-20,2021-10-22,ACTUAL,2020-09-02,ACTUAL,2020-09-02,2021-10,2021-10-31,2021-03-29,ACTUAL,2021-03-29,2021-03-10,ACTUAL,2021-03-10,,INTERVENTIONAL,,,A Trial to Evaluate Safety and Efficacy of Rivaroxaban (COVID-19),"A Randomized, Controlled, Phase 2b Study to Evaluate Safety and Efficacy of Rivaroxaban (Xarelto®) for High Risk People With Mild COVID-19",TERMINATED,,PHASE2,497.0,ACTUAL,Bill & Melinda Gates Medical Research Institute,"Based on Data Monitoring Committee's recommendation on 3 February 2021, the study was stopped on 4 February 2021 due to futility.",2.0,,"Based on Data Monitoring Committee''s recommendation on 3 February 2021, the study was stopped on 4 February 2021 due to futility.",f,,,,t,t,f,,,,,,,,,YES,,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,OTHER,,,,,,,2021,0.0
NCT04617847,,2020-10-30,2021-12-17,,2022-01-19,2020-10-30,2020-11-05,ACTUAL,2022-01-19,2022-02-09,ACTUAL,,,,2022-01-19,2022-02-09,ACTUAL,2020-04-13,ACTUAL,2020-04-13,2022-01,2022-01-31,2021-05-03,ACTUAL,2021-05-03,2021-05-03,ACTUAL,2021-05-03,,INTERVENTIONAL,,,Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease,"A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120101 in Patients With Huntington's Disease",TERMINATED,,PHASE1/PHASE2,27.0,ACTUAL,Wave Life Sciences Ltd.,,1.0,,Lack of efficacy,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2021,0.0
NCT04903327,,2021-05-21,,,2023-01-05,2021-05-21,2021-05-26,ACTUAL,,,,,,,2023-01-05,2023-01-09,ACTUAL,2021-11-16,ACTUAL,2021-11-16,2023-01,2023-01-31,2022-11-23,ACTUAL,2022-11-23,2022-08-29,ACTUAL,2022-08-29,,INTERVENTIONAL,,,Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress,Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells,TERMINATED,,PHASE2,43.0,ACTUAL,"Sorrento Therapeutics, Inc.",,2.0,,"Due to considerably slow enrollment, unable to reach enrollment targets",f,,,,,t,f,,,,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,INDUSTRY,,,,,,,2022,0.0
NCT04088500,,2019-09-10,2022-11-15,,2022-12-15,2019-09-11,2019-09-12,ACTUAL,2022-12-15,2023-01-10,ACTUAL,,,,2022-12-15,2023-01-10,ACTUAL,2020-09-03,ACTUAL,2020-09-03,2022-12,2022-12-31,2021-11-15,ACTUAL,2021-11-15,2021-11-15,ACTUAL,2021-11-15,,INTERVENTIONAL,,,A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma,"A Phase 2, Single-arm Open-label Study of Combination Nivolumab and Ipilimumab Retreatment in Advanced Renal Cell Carcinoma Patients Progressing on Nivolumab Maintenance Therapy After Nivolumab and Ipilimumab Induction",TERMINATED,,PHASE2,5.0,ACTUAL,Bristol-Myers Squibb,"The study was terminated early, leading to small numbers of participants analyzed.",1.0,,Slow accrual,f,,,,f,t,f,,,,,,,,,,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2021,0.0
NCT03556345,,2018-06-01,,,2022-01-12,2018-06-12,2018-06-14,ACTUAL,,,,,,,2022-01-12,2022-01-13,ACTUAL,2018-07-10,ACTUAL,2018-07-10,2022-01,2022-01-31,2020-08-31,ACTUAL,2020-08-31,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,,,A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2,"A Multicenter, Open Label，Single Arm，Phase II Study to Evaluate the Effect and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection in HER2 Overexpressing Local Advanced or Metastatic Gastric Cancer",COMPLETED,,PHASE2,127.0,ACTUAL,"RemeGen Co., Ltd.",,1.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2020,1.0
NCT05921929,,2023-06-06,,,2024-05-02,2023-06-23,2023-06-27,ACTUAL,,,,,,,2024-05-02,2024-05-03,ACTUAL,2024-05-02,ACTUAL,2024-05-02,2024-05,2024-05-31,2024-05-02,ACTUAL,2024-05-02,2024-05-02,ACTUAL,2024-05-02,,INTERVENTIONAL,,,"First-In-Human (FIH), Single Ascending Dose (SAD) Study of FluoroEthylNorMemantine (FENM)","Safety and Pharmacokinetics of a Novel NMDA Receptor Antagonist Against Brain Related Diseases in Healthy Adult Volunteers: First-in-human, Phase I, Single Dose-escalating, Open Label Study",WITHDRAWN,,PHASE1,0.0,ACTUAL,ReST Therapeutics,,1.0,,a new trial should be designed,f,,,,f,f,f,,,,,,,,,,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2024,0.0
NCT04523571,,2020-08-18,2022-08-10,,2023-09-15,2020-08-20,2020-08-21,ACTUAL,2023-09-15,2023-09-18,ACTUAL,,,,2023-09-15,2023-09-18,ACTUAL,2020-07-28,ACTUAL,2020-07-28,2023-09,2023-09-30,2021-08-10,ACTUAL,2021-08-10,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,,,Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects,"Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects: A Phase I, Randomized, Placebo-controlled, Observer-blind Study",COMPLETED,,PHASE1,144.0,ACTUAL,BioNTech SE,,6.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 21:44:10.17736,2024-10-15 21:44:10.17736,INDUSTRY,,,,,,,2021,1.0
NCT02618434,,2015-11-20,2023-11-03,,2024-03-15,2015-11-25,2015-12-01,ESTIMATED,2024-03-15,2024-03-18,ACTUAL,,,,2024-03-15,2024-03-18,ACTUAL,2016-02-16,ACTUAL,2016-02-16,2024-03,2024-03-31,2020-02-14,ACTUAL,2020-02-14,2019-11-15,ACTUAL,2019-11-15,,INTERVENTIONAL,,Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry.,Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2),Assessment of the Efficacy and Safety of Molindone Hydrochloride Extended-Release for the Treatment of Impulsive Aggression in Pediatric Patients With Attention Deficit/Hyperactivity Disorder in Conjunction With Standard ADHD Treatment,COMPLETED,,PHASE3,297.0,ACTUAL,"Supernus Pharmaceuticals, Inc.",,3.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,INDUSTRY,,,,,,,2020,1.0
NCT04032171,,2019-07-23,2021-05-28,,2021-07-13,2019-07-23,2019-07-25,ACTUAL,2021-07-13,2021-08-05,ACTUAL,,,,2021-07-13,2021-08-05,ACTUAL,2019-09-10,ACTUAL,2019-09-10,2021-07,2021-07-31,2020-05-20,ACTUAL,2020-05-20,2020-05-20,ACTUAL,2020-05-20,,INTERVENTIONAL,,"Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0074. Consequently, this trial terminated early, therefore no participants enrolled in Avonex® + Evobrutinib matched Placebo arm.",Study of Evobrutinib in Participants With RMS,"A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With an Interferon Beta 1a (Avonex®), in Participants With RMS to Evaluate Efficacy and Safety",TERMINATED,,PHASE3,1.0,ACTUAL,EMD Serono,"Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0074. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study.",2.0,,"Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0074. Consequently, this trial terminated early.",f,,,,t,t,f,,,,,,,,,YES,"Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html.",2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,INDUSTRY,,,,,,,2020,0.0
NCT01526135,,2012-02-01,,,2022-01-03,2012-02-02,2012-02-03,ESTIMATED,,,,,,,2022-01-03,2022-01-04,ACTUAL,2012-04-16,ACTUAL,2012-04-16,2022-01,2022-01-31,2021-07-16,ACTUAL,2021-07-16,2018-03,ACTUAL,2018-03-31,,INTERVENTIONAL,,,Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma,"Multicentric Randomized Phase III Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mFolfirinox) in Patients With Resected Pancreatic Adenocarcinoma",COMPLETED,,PHASE3,493.0,ACTUAL,UNICANCER,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,OTHER,,,,,,,2021,1.0
NCT02547116,,2015-09-09,,,2021-01-12,2015-09-10,2015-09-11,ESTIMATED,,,,,,,2021-01-12,2021-01-14,ACTUAL,2020-12,ESTIMATED,2020-12-31,2020-01,2020-01-31,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Epidemiology and Treatment of Small-colony Variant Staphylococcus Aureus in Cystic Fibrosis,Epidemiology and Treatment of Small-colony Variant Staphylococcus Aureus in Cystic Fibrosis,WITHDRAWN,,PHASE4,0.0,ACTUAL,Johns Hopkins University,,2.0,,Administrative delay,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,OTHER,,,,,,,2021,0.0
NCT02891798,,2016-08-12,2021-10-13,,2022-01-05,2016-08-31,2016-09-08,ESTIMATED,2021-11-19,2021-12-20,ACTUAL,,,,2022-01-05,2022-01-14,ACTUAL,2016-10,,2016-10-31,2022-01,2022-01-31,2021-08-20,ACTUAL,2021-08-20,2021-07-12,ACTUAL,2021-07-12,,INTERVENTIONAL,,Veterans undergoing hip/knee replacement surgery completing the study course,4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans,4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans,COMPLETED,,PHASE3,98.0,ACTUAL,VA Pittsburgh Healthcare System,"The sample size determined before the study began was N=100 patients to undergo primary THA and N=100 patients to undergo primary TKA, with these patients not undergoing physical therapy until day-one after surgery; these sample sizes were ultimately not achieved. By early 2018, same-day physical therapy (after surgery) became the new hospital guideline for patients undergoing primary THA and TKA, such that by mid-2018, the study was interrupted. Only the described 78 patients completed.",2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,FED,,,,,,,2021,1.0
NCT05153499,,2021-11-17,2023-04-10,,2023-10-19,2021-12-09,2021-12-10,ACTUAL,2023-10-19,2023-11-13,ACTUAL,,,,2023-10-19,2023-11-13,ACTUAL,2021-11-15,ACTUAL,2021-11-15,2023-10,2023-10-31,2023-02-24,ACTUAL,2023-02-24,2023-02-24,ACTUAL,2023-02-24,,INTERVENTIONAL,PRISM4,Intent to Treat (ITT) population used.,A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4),"A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides Difficile Infection (CDI)",TERMINATED,,PHASE3,19.0,ACTUAL,Finch Research and Development LLC.,Study was terminated early. Most analyses were not performed.,2.0,,"The termination of FIN-CDI-301 (PRISM4) is based on the voluntary, business-related decision of the sponsor.",f,,,,t,t,f,,,,,,,,,,,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,INDUSTRY,,,,,,,2023,0.0
NCT00589316,,2008-01-03,2022-12-09,,2023-01-23,2008-01-03,2008-01-09,ESTIMATED,2023-01-23,2023-02-09,ACTUAL,,,,2023-01-23,2023-02-09,ACTUAL,2007-10-05,ACTUAL,2007-10-05,2023-01,2023-01-31,2021-10-01,ACTUAL,2021-10-01,2016-10-01,ACTUAL,2016-10-01,,INTERVENTIONAL,,,"Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation and Donor Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or High-Risk Myelodysplastic Syndrome","Hematopoietic Bone Marrow Transplantation for Patients With High-risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS) Using Related HLA-Mismatched Donors: A Trial Using Radiolabeled Anti-CD45 Antibody Combined With Immunosuppression Before and After Transplantation",TERMINATED,,PHASE1,26.0,ACTUAL,Fred Hutchinson Cancer Center,"Study accrual has been lower (i.e., 26 total) than the planned target accrual of 50 due to the prioritization of other clinical trials using an alternative radiometal (yttrium-90 \[90Y\]) and antibody construct (BC8-DOTA).",1.0,,Terminated due to loss of funding,f,,,,f,,,,,,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,OTHER,,,,,,,2021,0.0
NCT02833207,,2016-07-12,,,2022-01-28,2016-07-12,2016-07-14,ESTIMATED,,,,,,,2022-01-28,2022-02-11,ACTUAL,2012-04-16,ACTUAL,2012-04-16,2022-01,2022-01-31,2021-11,ACTUAL,2021-11-30,2021-11,ACTUAL,2021-11-30,,INTERVENTIONAL,ObeseDilate,,Peripheral Vasodilation in Obese Humans,Peripheral Vasodilation in Obese Humans,TERMINATED,,PHASE1,8.0,ACTUAL,"University of Wisconsin, Madison",,4.0,,"Due to COVID-19, difficulty obtaining study drugs, difficulty recruiting obese subjects, and limited access to on-call physicians.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,OTHER,,,,,,,2021,0.0
NCT03087851,,2017-03-13,2020-11-26,,2021-02-03,2017-03-17,2017-03-23,ACTUAL,2020-12-22,2021-01-14,ACTUAL,,,,2021-02-03,2021-02-21,ACTUAL,2017-03-13,ACTUAL,2017-03-13,2021-02,2021-02-28,2020-08-01,ACTUAL,2020-08-01,2020-08-01,ACTUAL,2020-08-01,,INTERVENTIONAL,ZOLARMAB,,Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis,Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis,COMPLETED,,PHASE4,61.0,ACTUAL,Aarhus University Hospital,"Open-label design, no assessment by VFA or X-ray of VFx at baseline, changes in treatment not in accordance with the protocol. Information about BMD before initiation of DMAB is not available and the BMD loss can therefore not be evaluated in the context of the BMD gain during DMAB. Our p-CTX cutoff was 50% above the normal range for postmenopausal women and elderly men and it cannot be ruled out that the outcome of the study would have been different with a different cutoff.",3.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,OTHER,,,,,,,2020,1.0
NCT04434131,,2020-06-09,2021-03-15,,2023-02-08,2020-06-14,2020-06-16,ACTUAL,2023-02-08,2023-03-08,ACTUAL,,,,2023-02-08,2023-03-08,ACTUAL,2020-04-28,ACTUAL,2020-04-28,2023-02,2023-02-28,2021-03-12,ACTUAL,2021-03-12,2020-07-31,ACTUAL,2020-07-31,,INTERVENTIONAL,,,Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19,"Open, Non-comparative Pilot Study to Provide Access to Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19",COMPLETED,,PHASE2,12.0,ACTUAL,University of New Mexico,,1.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,OTHER,,,,,,,2021,1.0
NCT04116164,,2019-10-01,,,2023-09-21,2019-10-02,2019-10-04,ACTUAL,,,,,,,2023-09-21,2023-09-25,ACTUAL,2019-09-18,ACTUAL,2019-09-18,2023-09,2023-09-30,2023-07-06,ACTUAL,2023-07-06,2023-07-06,ACTUAL,2023-07-06,,INTERVENTIONAL,,,Safety and Targeting of Anti-hk2 Antibody in mCRPC,A Phase 0 Study to Assess the Safety and Biodistribution of a Novel Radiolabeled Antibody Targeting Human Kallikrein-2 (hk2) in Subjects With Metastatic Castration-resistant Prostate Cancer.,TERMINATED,,EARLY_PHASE1,27.0,ACTUAL,SpectronRX,,1.0,,Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,INDUSTRY,,,,,,,2023,0.0
NCT03967093,,2019-05-21,,,2021-07-21,2019-05-28,2019-05-30,ACTUAL,,,,,,,2021-07-21,2021-07-22,ACTUAL,2019-04-15,ACTUAL,2019-04-15,2021-07,2021-07-31,2020-01-17,ACTUAL,2020-01-17,2020-01-03,ACTUAL,2020-01-03,,INTERVENTIONAL,KOURAGE,,A Study of BXQ-350 in Children and Young Adults With Relapsed Solid Tumors,"A Phase 1 Safety Study of BXQ-350 Administered as a Single Agent by Intravenous Infusion in Children and Young Adults With Relapsed Solid Tumors, Including Recurrent Malignant Brain Tumors",TERMINATED,,PHASE1,9.0,ACTUAL,"Bexion Pharmaceuticals, Inc.",,5.0,,Bexion will not move forward with the Part 2 expansion portion of the trial in order to focus resources on the further development of BXQ-350 as an earlier treatment measure in the pediatric population.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,INDUSTRY,,,,,,,2020,0.0
NCT02625090,,2015-12-04,2021-11-23,,2022-03-08,2015-12-04,2015-12-09,ESTIMATED,2021-11-23,2022-01-31,ACTUAL,,,,2022-03-08,2022-03-09,ACTUAL,2015-12-03,ACTUAL,2015-12-03,2022-03,2022-03-31,2020-11-24,ACTUAL,2020-11-24,2020-11-24,ACTUAL,2020-11-24,,INTERVENTIONAL,,Baseline Characteristics refer to the Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of UCB0942 in the EP0073 study.,An Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy,"An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of UCB0942 When Used as Adjunctive Therapy for Partial-onset Seizures in Adult Subjects With Highly Drug-resistant Focal Epilepsy",TERMINATED,,PHASE2,42.0,ACTUAL,UCB Pharma,,1.0,,"Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure",f,,,,t,,,,,,,,,,,,,2024-10-15 10:57:56.739665,2024-10-15 10:57:56.739665,INDUSTRY,,,,,,,2020,0.0
NCT03888534,,2019-03-22,,,2020-09-24,2019-03-22,2019-03-25,ACTUAL,,,,,,,2020-09-24,2020-09-28,ACTUAL,2020-10-31,ESTIMATED,2020-10-31,2020-09,2020-09-30,2022-08-30,ESTIMATED,2022-08-30,2022-08-30,ESTIMATED,2022-08-30,,INTERVENTIONAL,,,Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LLy),"Open-Label Phase 1 Study to Assess the Maximum Tolerated Dose, Pharmacokinetics, and Safety of Ixazomib Administered Intravenously to Pediatric Patients Aged 0 to <18 Years With Relapsed or Refractory Acute Lymphoblastic Leukemia, With or Without Extramedullary Disease, or Relapsed or Refractory Lymphoblastic Lymphoma",WITHDRAWN,,PHASE1,0.0,ACTUAL,Takeda,,1.0,,Business decision (no safety or efficacy concerns),f,,,,t,t,f,,,,,,,,,YES,"Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,INDUSTRY,,,,,,,2022,0.0
NCT02510261,,2015-07-16,2023-11-16,,2023-12-05,2015-07-27,2015-07-29,ESTIMATED,2023-12-05,2023-12-06,ACTUAL,,,,2023-12-05,2023-12-06,ACTUAL,2015-07-16,ACTUAL,2015-07-16,2023-11,2023-11-30,2022-11-23,ACTUAL,2022-11-23,2022-11-23,ACTUAL,2022-11-23,,INTERVENTIONAL,,Full analysis set included all participants who were enrolled in this study.,"The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Participants Who Have Already Been Treated With ALN-TTR02 (Patisiran)","A Multicenter, Open-Label, Extension Study to Evaluate the Long-term Safety and Efficacy of Patisiran in Patients With Familial Amyloidotic Polyneuropathy Who Have Completed a Prior Patisiran Clinical Study",COMPLETED,,PHASE3,211.0,ACTUAL,Alnylam Pharmaceuticals,,3.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,INDUSTRY,,,,,,,2022,1.0
NCT02867332,,2016-08-11,,,2019-03-04,2016-08-11,2016-08-15,ESTIMATED,,,,,,,2019-03-04,2019-03-06,ACTUAL,2016-11,,2016-11-30,2016-08,2016-08-31,2020-11,ESTIMATED,2020-11-30,2020-11,ESTIMATED,2020-11-30,,INTERVENTIONAL,,,PD-1 Knockout Engineered T Cells for Metastatic Renal Cell Carcinoma.,A Dose-escalation Phase I Trial of PD-1 Knockout Engineered T Cells for the Treatment of Metastatic Renal Cell Carcinoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,Peking University,,2.0,,No funding,f,,,,t,,,,,,,,,,,UNDECIDED,plan to do,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,OTHER,,,,,,,2020,0.0
NCT03845517,,2019-02-15,2024-06-28,,2024-08-29,2019-02-15,2019-02-19,ACTUAL,2024-08-29,2024-09-05,ACTUAL,,,,2024-08-29,2024-09-05,ACTUAL,2019-04-18,ACTUAL,2019-04-18,2024-08,2024-08-31,2023-10-05,ACTUAL,2023-10-05,2023-10-05,ACTUAL,2023-10-05,,INTERVENTIONAL,,Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.,A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE),"A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)",COMPLETED,,PHASE2,350.0,ACTUAL,Pfizer,"For the PF-06700841 30 mg, there was a total of 1 death which was reported in both on-treatment and follow-up phases in participant flow section.",4.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,INDUSTRY,,,,,,,2023,1.0
NCT04855565,,2021-04-16,,,2021-08-25,2021-04-20,2021-04-22,ACTUAL,,,,,,,2021-08-25,2021-08-30,ACTUAL,2021-05-19,ACTUAL,2021-05-19,2021-08,2021-08-31,2021-08-03,ACTUAL,2021-08-03,2021-08-03,ACTUAL,2021-08-03,,INTERVENTIONAL,,,ALY688-SR in Generally Healthy Overweight or Obese Adults,"Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of ALY688-SR in Generally Healthy Overweight or Obese Adults",TERMINATED,,PHASE1,8.0,ACTUAL,Allysta Pharmaceutical,,2.0,,Inability to recruit due to COVID-19 pandemic restrictions,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,INDUSTRY,,,,,,,2021,0.0
NCT04347226,,2020-04-02,,,2021-11-18,2020-04-14,2020-04-15,ACTUAL,,,,,,,2021-11-18,2021-11-30,ACTUAL,2020-04-16,ACTUAL,2020-04-16,2021-11,2021-11-30,2021-03-01,ACTUAL,2021-03-01,2021-03-01,ACTUAL,2021-03-01,,INTERVENTIONAL,,,Anti-Interleukin-8 (Anti-IL-8) for Patients With COVID-19,A Randomized Phase 2 Study of Anti-IL-8 Therapy Versus Standard of Care in the Treatment of Hospitalized Patients With Severe COVID-19,TERMINATED,,PHASE2,43.0,ACTUAL,Columbia University,,2.0,,Interim analysis indicated that futility boundary was reached.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 08:01:25.095433,2024-10-16 08:01:25.095433,OTHER,,,,,,,2021,0.0
NCT02961816,,2016-11-09,,,2017-04-20,2016-11-09,2016-11-11,ESTIMATED,,,,,,,2017-04-20,2017-04-21,ACTUAL,2017-06,ESTIMATED,2017-06-30,2017-04,2017-04-30,2021-06,ESTIMATED,2021-06-30,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,Panobinostat Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Lymphoma,Panobinostat Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Lymphoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,3.0,,Lack of funding,f,,,,f,t,f,,,,,,,,,,,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,OTHER,,,,,,,2021,0.0
NCT03839355,,2019-02-11,2021-02-05,,2021-02-23,2019-02-13,2019-02-15,ACTUAL,2021-02-23,2021-03-16,ACTUAL,,,,2021-02-23,2021-03-16,ACTUAL,2018-12-19,ACTUAL,2018-12-19,2021-02,2021-02-28,2020-12-15,ACTUAL,2020-12-15,2020-12-15,ACTUAL,2020-12-15,,INTERVENTIONAL,ARISTA,,"Trial of Apixaban vs Warfarin in Reducing Rate of Cognitive Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Patients With Atrial Fibrillation","Randomized Trial of Apixaban vs Dose Adjusted Warfarin in Reducing Rate of Cognitive Function Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Non-valvular Atrial Fibrillation Patients With CHA2DS2-VaSc Score = 2",TERMINATED,,PHASE3,34.0,ACTUAL,Mayo Clinic,,2.0,,Study terminated due to slower than anticipated enrollment.,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,OTHER,,,,,,,2020,0.0
NCT04006652,,2019-07-01,,,2023-05-17,2019-07-01,2019-07-05,ACTUAL,,,,,,,2023-05-17,2023-05-19,ACTUAL,2020-12-16,ACTUAL,2020-12-16,2023-05,2023-05-31,2022-12-19,ACTUAL,2022-12-19,2022-12-19,ACTUAL,2022-12-19,,INTERVENTIONAL,,,ApoGraft for the Prevention of Acute Graft Versus Host Disease in Haploidentical Hematopoietic Cell Transplant Recipients,A Phase I Study of ApoGraft for the Prevention of Acute Graft Versus Host Disease in Haploidentical Hematopoietic Cell Transplant Recipients,TERMINATED,,PHASE1,4.0,ACTUAL,Washington University School of Medicine,,2.0,,Lost funding,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,OTHER,,,,,,,2022,0.0
NCT03241745,,2017-08-03,,,2024-04-03,2017-08-04,2017-08-07,ACTUAL,,,,,,,2024-04-03,2024-04-05,ACTUAL,2017-08-03,ACTUAL,2017-08-03,2024-04,2024-04-30,2024-04-01,ACTUAL,2024-04-01,2024-04-01,ACTUAL,2024-04-01,,INTERVENTIONAL,,,A Study of Nivolumab in Selected Uterine Cancer Patients,Phase II Trial of Single-Agent Nivolumab in Patients With Microsatellite Unstable/Mismatch Repair Deficient/Hypermutated Uterine Cancer,COMPLETED,,PHASE2,35.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,,f,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-16 17:13:50.880785,2024-10-16 17:13:50.880785,OTHER,,,,,,,2024,1.0
NCT03711162,,2018-10-15,2022-02-16,,2022-07-06,2018-10-17,2018-10-18,ACTUAL,2022-07-06,2022-07-29,ACTUAL,,,,2022-07-06,2022-07-29,ACTUAL,2018-11-28,ACTUAL,2018-11-28,2022-07,2022-07-31,2021-03-30,ACTUAL,2021-03-30,2021-03-30,ACTUAL,2021-03-30,,INTERVENTIONAL,ISABELA1,Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of investigational product (IP).,A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care,"A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis",TERMINATED,,PHASE3,525.0,ACTUAL,Galapagos NV,This Study was prematurely terminated based on recommendations of the Independent Data Monitoring Committee.,3.0,,The benefit-risk profile no longer supports continuing the study,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:03:23.01947,2024-10-15 11:03:23.01947,INDUSTRY,,,,,,,2021,0.0
NCT05110651,,2020-03-29,,,2021-11-05,2021-11-05,2021-11-08,ACTUAL,,,,,,,2021-11-05,2021-11-08,ACTUAL,2020-04-10,ESTIMATED,2020-04-10,2021-11,2021-11-30,2020-10-01,ESTIMATED,2020-10-01,2020-07-31,ESTIMATED,2020-07-31,,INTERVENTIONAL,,,The Danish Pre-HCQ COVID Dialysis Study,The Danish Pre-HCQ Dialysis Study: Hydroxychloroquine for Prevention of COVID19 in Dialysis-treated Patients With End-stage Renal Disease - A Multicenter Parallel-group Open Randomized Clinical Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,"Rigshospitalet, Denmark",,2.0,,No funding,f,,,,t,f,f,,,f,,,Aggregated data will be available within 12 months of study completion,All data access requests via email. Requestors will be required to sign a Data Access Agreement,,YES,Aggregated de-identified individual participant data for primary and secondary outcomes measures will be made available,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,OTHER,,,,,,,2020,0.0
NCT05788458,,2023-03-15,,,2023-11-24,2023-03-27,2023-03-28,ACTUAL,,,,,,,2023-11-24,2023-11-27,ACTUAL,2023-04-01,ACTUAL,2023-04-01,2023-11,2023-11-30,2023-11-01,ACTUAL,2023-11-01,2023-10-01,ACTUAL,2023-10-01,,INTERVENTIONAL,,,Effect of Bupivacaine Concentration on Ultrasound Guided Pericapsular Group Nerve Block Efficacy in Hip Surgery Patients,Effect of Bupivacaine Concentration on Ultrasound Guided Pericapsular Group Nerve Block Efficacy in Hip Surgery Patients: A Randomized Controlled Double Blinded Trial,COMPLETED,,PHASE4,135.0,ACTUAL,Benha University,,3.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 11:03:23.01947,2024-10-15 11:03:23.01947,OTHER,,,,,,,2023,1.0
NCT03855137,,2019-02-25,2023-01-18,,2023-01-18,2019-02-25,2019-02-26,ACTUAL,2023-01-18,2023-02-14,ACTUAL,,,,2023-01-18,2023-02-14,ACTUAL,2019-03-11,ACTUAL,2019-03-11,2023-01,2023-01-31,2022-01-20,ACTUAL,2022-01-20,2022-01-20,ACTUAL,2022-01-20,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all randomized participants.,"Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine","A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)",COMPLETED,,PHASE3,778.0,ACTUAL,Allergan,,3.0,,,f,,,,t,t,f,,,f,,,"For details on when studies are available for sharing visit, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,INDUSTRY,,,,,,,2022,1.0
NCT04810104,,2021-03-15,,,2022-10-11,2021-03-18,2021-03-22,ACTUAL,,,,,,,2022-10-11,2022-10-14,ACTUAL,2022-10,ESTIMATED,2022-10-31,2022-06,2022-06-30,2024-04,ESTIMATED,2024-04-30,2024-01,ESTIMATED,2024-01-31,,INTERVENTIONAL,PD-MIND,,Parkinson's Disease With Mild Cognitive Impairment Treated With Nicotinic Agonist Drug,Parkinson's Disease With Mild Cognitive Impairment Treated With Nicotinic Agonist Drug,WITHDRAWN,,PHASE2,0.0,ACTUAL,King's College London,,2.0,,Delays due to COVID,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,OTHER,,,,,,,2024,0.0
NCT04556617,,2020-09-14,,,2022-10-04,2020-09-14,2020-09-21,ACTUAL,,,,,,,2022-10-04,2022-10-05,ACTUAL,2020-09-21,ACTUAL,2020-09-21,2022-10,2022-10-31,2022-05-24,ACTUAL,2022-05-24,2022-05-24,ACTUAL,2022-05-24,,INTERVENTIONAL,,,PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC),"A Multicenter, Open-Label, Parallel, Phase 1b/2a Study of PLX2853 in Combination With Abiraterone Acetate and Prednisone and Phase 1b/2a Study of PLX2853 in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)",TERMINATED,,PHASE1/PHASE2,19.0,ACTUAL,Opna Bio LLC,,2.0,,study terminated due to business realignment,f,,,,f,t,f,,,,,,,,,,,2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,INDUSTRY,,,,,,,2022,0.0
NCT05522673,,2022-08-30,2024-02-08,,2024-02-08,2022-08-30,2022-08-31,ACTUAL,2024-02-08,2024-03-05,ACTUAL,,,,2024-02-08,2024-03-05,ACTUAL,2023-02-08,ACTUAL,2023-02-08,2024-01,2024-01-31,2024-01-30,ACTUAL,2024-01-30,2023-02-08,ACTUAL,2023-02-08,,INTERVENTIONAL,,,[11C]-(R)-Rolipram to Measure cAMP Signaling Before and After Ketamine,[11C]-(R)-Rolipram to Measure cAMP Signaling Before and After Ketamine,TERMINATED,,PHASE1,1.0,ACTUAL,National Institutes of Health Clinical Center (CC),Study was prematurely terminated due to low recruitment,1.0,,Low recruitment,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,NIH,,,,,,,2024,0.0
NCT03800602,,2019-01-09,2023-11-07,,2024-09-01,2019-01-09,2019-01-11,ACTUAL,2024-09-01,2024-09-05,ACTUAL,,,,2024-09-01,2024-09-05,ACTUAL,2019-01-15,ACTUAL,2019-01-15,2024-09,2024-09-30,2021-09-04,ACTUAL,2021-09-04,2020-09-04,ACTUAL,2020-09-04,,INTERVENTIONAL,,,Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal Cancer,Phase II Trial of Nivolumab and Metformin in Patients With Treatment Refractory MSS Metastatic Colorectal Cancer,COMPLETED,,PHASE2,29.0,ACTUAL,Emory University,,1.0,,,,,,,t,t,f,,,,,,,,,,,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,OTHER,,,,,,,2021,0.0
NCT04609579,,2020-10-23,,,2024-01-28,2020-10-23,2020-10-30,ACTUAL,,,,,,,2024-01-28,2024-01-30,ACTUAL,2020-11-18,ACTUAL,2020-11-18,2024-01,2024-01-31,2024-01-06,ACTUAL,2024-01-06,2024-01-06,ACTUAL,2024-01-06,,INTERVENTIONAL,,,Study of SNX281 in Subjects With Advanced Solid Tumors and Lymphoma,A Phase 1 Open-label Study of SNX281 Given as Monotherapy and in Combination With a Checkpoint Inhibitor in Subjects With Advanced Solid Tumors and Lymphoma,TERMINATED,,PHASE1,27.0,ACTUAL,"Stingthera, Inc.",,2.0,,Sponsor decision (not due to safety concerns),f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,INDUSTRY,,,,,,,2024,0.0
NCT02128763,,2014-04-28,2018-08-28,,2022-06-23,2014-04-29,2014-05-01,ESTIMATED,2018-12-12,2019-01-04,ACTUAL,,,,2022-06-23,2022-07-19,ACTUAL,2014-11,,2014-11-30,2022-06,2022-06-30,2020-01-31,ACTUAL,2020-01-31,2017-09-05,ACTUAL,2017-09-05,,INTERVENTIONAL,DREAM,,Dry Eye Assessment and Management Study,Dry Eye Assessment and Management Study,COMPLETED,,PHASE3,535.0,ACTUAL,University of Pennsylvania,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,OTHER,,,,,,,2020,1.0
NCT05261711,,2022-02-20,,,2024-07-24,2022-02-20,2022-03-02,ACTUAL,,,,,,,2024-07-24,2024-07-26,ACTUAL,2022-12-05,ACTUAL,2022-12-05,2024-07,2024-07-31,2024-11,ESTIMATED,2024-11-30,2024-11,ESTIMATED,2024-11-30,,INTERVENTIONAL,(SCD),,AB1 in Adult Patients With Sickle Cell Disease (SCD),"A Phase 1/2, Open-Label, Dose Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AB1 in Adult Patients With Sickle Cell Disease (SCD)",SUSPENDED,,PHASE1/PHASE2,39.0,ESTIMATED,Duke University,,1.0,,Study is currently on hold pending a protocol amendment to change the dosing.,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:03:23.01947,2024-10-15 11:03:23.01947,OTHER,,,,,,,2024,0.0
NCT04362111,,2020-04-21,2023-05-16,,2023-08-01,2020-04-23,2020-04-24,ACTUAL,2023-08-01,2023-08-24,ACTUAL,,,,2023-08-01,2023-08-24,ACTUAL,2020-08-01,ACTUAL,2020-08-01,2023-08,2023-08-31,2023-06-01,ACTUAL,2023-06-01,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Early Treatment of Cytokine Storm Syndrome in Covid-19,Early Treatment of Cytokine Storm Syndrome in Covid-19,COMPLETED,,PHASE3,32.0,ACTUAL,University of Alabama at Birmingham,"1. All subjects received daily dexamethasone to the standard of care management of Covid-19 pneumonia requiring hospitalization.~2. Some of the enrolled subjects with rapid improvement were discharged prior to 10 days with instructions on anakinra self-administration at home; adherence with unsupervised dosing of study agent could not be readily assessed, nor could reported oxygen saturations be confirmed in these participants.",2.0,,,f,,,,t,t,f,,,f,,,During study enrollment,wchatham@uabmc.edu,,YES,Contact PI by e-mail for protocol specifics Submission of results for peer reviewed publication,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,OTHER,,,,,,,2023,0.0
NCT04267393,,2020-02-11,2024-08-09,,2024-08-09,2020-02-11,2020-02-12,ACTUAL,2024-08-09,2024-09-04,ACTUAL,,,,2024-08-09,2024-09-04,ACTUAL,2021-03-17,ACTUAL,2021-03-17,2024-08,2024-08-31,2024-02-09,ACTUAL,2024-02-09,2023-08-16,ACTUAL,2023-08-16,,INTERVENTIONAL,,All Randomized Participants,Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH),"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults With Compensated Cirrhosis From Nonalcoholic Steatohepatitis (NASH)",TERMINATED,,PHASE2,124.0,ACTUAL,Bristol-Myers Squibb,,3.0,,Trial terminated because of lack of efficacy in the short term acute phase.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,INDUSTRY,,,,,,,2024,0.0
NCT03720717,,2018-10-24,2024-06-22,,2024-08-29,2018-10-24,2018-10-25,ACTUAL,2024-08-29,2024-09-05,ACTUAL,,,,2024-08-29,2024-09-05,ACTUAL,2020-10-27,ACTUAL,2020-10-27,2024-08,2024-08-31,2022-10-28,ACTUAL,2022-10-28,2022-10-28,ACTUAL,2022-10-28,,INTERVENTIONAL,,,Baclofen as a Perioperative Analgesic Adjuvant,Baclofen as a Perioperative Analgesic Adjuvant,TERMINATED,,PHASE4,34.0,ACTUAL,University of Alabama at Birmingham,,4.0,,Futility analysis at midpoint analysis,f,,,,t,t,f,,,t,,,Published - Cureus 2024 - DOI: 10.7759/cureus,published,,YES,De-identified individual data available on reasonable request - currently in RedCap system,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,OTHER,,,,,,,2022,0.0
NCT04150250,,2019-10-31,2021-03-01,,2021-03-01,2019-10-31,2019-11-04,ACTUAL,2021-03-01,2021-03-25,ACTUAL,,,,2021-03-01,2021-03-25,ACTUAL,2019-11-04,ACTUAL,2019-11-04,2021-02,2021-02-28,2020-07-27,ACTUAL,2020-07-27,2020-07-27,ACTUAL,2020-07-27,,INTERVENTIONAL,CAST,All enrolled participants,Cholera Anti-Secretory Treatment Trial,"A Phase 2a Randomized, Single-Center, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Preliminary Efficacy of Oral iOWH032 Against Cholera Diarrhea in a Controlled Human Infection Model",COMPLETED,,PHASE2,47.0,ACTUAL,PATH,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,OTHER,,,,,,,2020,1.0
NCT05157464,,2021-12-02,,,2023-11-28,2021-12-02,2021-12-15,ACTUAL,,,,,,,2023-11-28,2023-12-01,ACTUAL,2023-09-01,ESTIMATED,2023-09-01,2023-11,2023-11-30,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Losartan Use to Mitigate Arthrofibrosis Following Total Join Arthroplasty,Losartan Use to Mitigate Arthrofibrosis Following Total Join Arthroplasty,WITHDRAWN,,PHASE4,0.0,ACTUAL,NYU Langone Health,,2.0,,"Study was not initiated, no participants enrolled.",f,,,,f,t,f,,,t,,,Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.,"The investigator who proposed to use the data will have access upon reasonable request. Requests should be directed to daniel.waren@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.",,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available upon reasonable request.",2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,OTHER,,,,,,,2024,0.0
NCT01842399,,2013-04-25,,,2022-12-21,2013-04-25,2013-04-29,ESTIMATED,,,,,,,2022-12-21,2022-12-23,ACTUAL,2015-07-14,ACTUAL,2015-07-14,2022-12,2022-12-31,2022-12-21,ACTUAL,2022-12-21,2020-07-31,ACTUAL,2020-07-31,,INTERVENTIONAL,,,Resveratrol and Cardiovascular Health in the Elderly,Resveratrol and Cardiovascular Health in the Elderly: The Reache Trial,TERMINATED,,PHASE1/PHASE2,73.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,The protocol experienced slow accrual.,f,,,,,t,f,,,,,,,,,UNDECIDED,.There is ongoing discussion within the NIA IRP and a plan has not been finalized yet.,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,NIH,,,,,,,2022,0.0
NCT05402995,,2022-04-05,2023-11-30,,2024-03-28,2022-05-27,2022-06-02,ACTUAL,2024-03-28,2024-04-24,ACTUAL,,,,2024-03-28,2024-04-24,ACTUAL,2022-06-21,ACTUAL,2022-06-21,2024-03,2024-03-31,2023-08-31,ACTUAL,2023-08-31,2023-08-31,ACTUAL,2023-08-31,,INTERVENTIONAL,,As study was terminated due to difficulty enrolling participants there was no one randomized to the reference/control group.,Randomized Trial Comparing Irrisept to Saline Irrigation for Infection Prevention,Prospective Randomized Control Trial Comparing Irrisept to Saline Irrigation for the Prevention of Infection After Open Tibia Fractures,TERMINATED,,PHASE4,6.0,ACTUAL,University of Missouri-Columbia,,4.0,,Enrollment was not progressing as expected.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 11:03:23.01947,2024-10-15 11:03:23.01947,OTHER,,,,,,,2023,0.0
NCT03557307,,2018-05-14,2022-02-07,,2023-05-09,2018-06-04,2018-06-15,ACTUAL,2022-06-22,2022-06-28,ACTUAL,,,,2023-05-09,2023-06-06,ACTUAL,2018-08-01,ACTUAL,2018-08-01,2023-05,2023-05-31,2022-03-24,ACTUAL,2022-03-24,2021-04-16,ACTUAL,2021-04-16,,INTERVENTIONAL,PONENTE,Full analysis set,Study to Evaluate Efficacy and Safety of Benralizumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma,"PONENTE: A Multicenter, Open-label, Phase 3b Efficacy and Safety Study of Benralizumab 30 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Patients With Severe Eosinophilic Asthma on High Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Chronic Oral Corticosteroid Therapy",COMPLETED,,PHASE3,598.0,ACTUAL,AstraZeneca,"During COVID-19 pandemic, for ongoing patients, patient dosing, and scheduled visits are inevitably impacted, but the primary endpoint was not impacted.",1.0,,,f,,,,,t,f,,,t,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,INDUSTRY,,,,,,,2022,1.0
NCT05453942,,2022-07-07,,,2023-02-14,2022-07-07,2022-07-12,ACTUAL,,,,,,,2023-02-14,2023-02-15,ACTUAL,2022-07-12,ACTUAL,2022-07-12,2023-02,2023-02-28,2023-02-09,ACTUAL,2023-02-09,2023-02-09,ACTUAL,2023-02-09,,INTERVENTIONAL,,,"A Study to Investigate Safety, Tolerability and Clinical Response With SAR441566 Compared With Placebo in Participants With Mild to Moderate Psoriasis","A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Clinical Response After 4-week Oral Treatment With SAR441566 Compared With Placebo in Participants With Mild to Moderate Psoriasis",COMPLETED,,PHASE1,38.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,f,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 11:03:23.01947,2024-10-15 11:03:23.01947,INDUSTRY,,,,,,,2023,1.0
NCT02576717,,2015-09-28,2023-12-12,,2024-01-03,2015-10-13,2015-10-15,ESTIMATED,2024-01-03,2024-01-30,ACTUAL,,,,2024-01-03,2024-01-30,ACTUAL,2015-10-16,ACTUAL,2015-10-16,2024-01,2024-01-31,2023-01-05,ACTUAL,2023-01-05,2023-01-05,ACTUAL,2023-01-05,,INTERVENTIONAL,,Demographics were summarized using the safety population - all participants enrolled in study RPC01-3001 who received at least one dose of open-label RPC1063.,"A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis","A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients",COMPLETED,,PHASE3,2494.0,ACTUAL,Celgene,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,INDUSTRY,,,,,,,2023,1.0
NCT03554200,,2018-05-17,,,2022-10-25,2018-05-30,2018-06-13,ACTUAL,,,,,,,2022-10-25,2022-10-27,ACTUAL,2018-06-11,ACTUAL,2018-06-11,2022-10,2022-10-31,2020-10-29,ACTUAL,2020-10-29,2020-10-29,ACTUAL,2020-10-29,,INTERVENTIONAL,,,EMPA Acute Heart Failure,Effect of Empagliflozin on Cardiac Output in Patients With Acute Heart Failure (EMPA Acute Heart Failure),TERMINATED,,PHASE2,19.0,ACTUAL,RWTH Aachen University,,2.0,,COVID 19,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,OTHER,,,,,,,2020,0.0
NCT03408652,,2018-01-08,,,2021-10-14,2018-01-23,2018-01-24,ACTUAL,,,,,,,2021-10-14,2021-10-22,ACTUAL,2019-03-15,ACTUAL,2019-03-15,2021-10,2021-10-31,2020-06-22,ACTUAL,2020-06-22,2020-06-22,ACTUAL,2020-06-22,,INTERVENTIONAL,MOSCAR,,Efficacy and Safety of Systemic Treatments of Bone Metastases From Kidney Cancer in Patients Treated With Targeted Therapies,Multicenter Randomized Phase III Study Evaluating the Efficacy and Safety of Systemic Treatments of Bone Metastases From Kidney Cancer in Patients Treated With Targeted Therapies,TERMINATED,,PHASE3,1.0,ACTUAL,Centre Leon Berard,,2.0,,lack of recruitment,f,,,,t,f,f,,,,,,,,,,,2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,OTHER,,,,,,,2020,0.0
NCT03278808,,2017-08-24,,,2020-02-25,2017-09-08,2017-09-12,ACTUAL,,,,,,,2020-02-25,2020-02-27,ACTUAL,2018-09-17,ACTUAL,2018-09-17,2020-02,2020-02-29,2020-01-01,ACTUAL,2020-01-01,2019-12-30,ACTUAL,2019-12-30,,INTERVENTIONAL,,,Chloroquine (CQ) and Azithromycin (AZ) Combination for Malaria Prophylaxis,A Phase 2a Open Label Study of the Safety and Efficacy of a Single Dose of Weekly Chloroquine (CQ) and Azithromycin (AZ) Administered in Combination for Malaria Prophylaxis in Healthy Adults Challenged With 7G8 Chloroquine-Resistant Plasmodium Falciparum in a Controlled Human Malaria Infection (CHMI) Model,WITHDRAWN,,PHASE2,0.0,ACTUAL,U.S. Army Medical Research and Development Command,,3.0,,The IND has been withdrawn from FDA,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,FED,,,,,,,2020,0.0
NCT05719012,,2023-01-29,,,2023-11-17,2023-02-07,2023-02-08,ACTUAL,,,,,,,2023-11-17,2023-11-21,ACTUAL,2023-04-01,ESTIMATED,2023-04-01,2023-11,2023-11-30,2024-03-30,ESTIMATED,2024-03-30,2023-12-01,ESTIMATED,2023-12-01,,INTERVENTIONAL,,,Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19,"Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19: a Randomized, Double-blind, Parallel-controlled Study",WITHDRAWN,,PHASE2,0.0,ACTUAL,Shanghai East Hospital,,2.0,,Difficulty in Recruitment,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 11:03:23.01947,2024-10-15 11:03:23.01947,OTHER,,,,,,,2024,0.0
NCT05431543,,2022-06-20,2024-08-14,,2024-08-14,2022-06-20,2022-06-24,ACTUAL,2024-08-14,2024-09-05,ACTUAL,,,,2024-08-14,2024-09-05,ACTUAL,2022-08-06,ACTUAL,2022-08-06,2024-08,2024-08-31,2022-12-14,ACTUAL,2022-12-14,2022-12-14,ACTUAL,2022-12-14,,INTERVENTIONAL,,,Evaluation of the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (LNZ100) in the Treatment of Presbyopia,"A Multicenter, Double-Masked Evaluation of the Safety and Effectiveness of Aceclidine + Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia",COMPLETED,,PHASE2,59.0,ACTUAL,"LENZ Therapeutics, Inc",,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,OTHER,,,,,,,2022,1.0
NCT03575572,,2018-06-18,2022-02-28,,2022-04-12,2018-06-28,2018-07-02,ACTUAL,2022-04-12,2022-05-09,ACTUAL,,,,2022-04-12,2022-05-09,ACTUAL,2018-08-29,ACTUAL,2018-08-29,2022-04,2022-04-30,2021-01-13,ACTUAL,2021-01-13,2021-01-13,ACTUAL,2021-01-13,,INTERVENTIONAL,CPFP,,Colchicine in Postoperative Fontan Patients,Colchicine in Postoperative Fontan Patients (CPFP),TERMINATED,,PHASE2/PHASE3,11.0,ACTUAL,University of Michigan,,1.0,,Staffing changes impacted by COVID-19 pandemic resulting in inadequate personnel to facilitate study.,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 21:49:45.203169,2024-10-15 21:49:45.203169,OTHER,,,,,,,2021,0.0
NCT04397718,,2020-05-14,2022-04-28,,2022-06-02,2020-05-19,2020-05-21,ACTUAL,2022-06-02,2022-06-06,ACTUAL,,,,2022-06-02,2022-06-06,ACTUAL,2020-07-06,ACTUAL,2020-07-06,2022-06,2022-06-30,2021-06-08,ACTUAL,2021-06-08,2021-06-08,ACTUAL,2021-06-08,,INTERVENTIONAL,HITCH,,Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization,"Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization (HITCH): A Multicenter, Phase 2 Randomized Controlled Trial of Best Supportive Care (BSC) vs BSC Plus Degarelix",COMPLETED,,PHASE2,96.0,ACTUAL,VA Office of Research and Development,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,FED,,,,,,,2021,1.0
NCT05631327,,2022-11-21,,,2024-05-23,2022-11-21,2022-11-30,ACTUAL,,,,,,,2024-05-23,2024-05-28,ACTUAL,2022-12-19,ACTUAL,2022-12-19,2024-05,2024-05-31,2024-04-24,ACTUAL,2024-04-24,2024-04-24,ACTUAL,2024-04-24,,INTERVENTIONAL,,,A JZP341 Study in Adult Participants With Advanced or Metastatic Solid Tumors,"Phase 1, Open-Label, Dose-Finding, and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of JZP341 in Adult Participants With Advanced or Metastatic Solid Tumors",TERMINATED,,PHASE1,12.0,ACTUAL,Jazz Pharmaceuticals,,2.0,,The study was terminated based on a business decision by the Sponsor.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,INDUSTRY,,,,,,,2024,0.0
NCT03189030,,2017-06-14,,,2020-09-29,2017-06-15,2017-06-16,ACTUAL,,,,,,,2020-09-29,2020-10-01,ACTUAL,2017-05-02,ACTUAL,2017-05-02,2020-09,2020-09-30,2020-09-02,ACTUAL,2020-09-02,2019-10-15,ACTUAL,2019-10-15,,INTERVENTIONAL,,,Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer,"A Phase 1 Safety and Tolerability Study of Personalized Live, Attenuated, Double-Deleted Listeria Monocytogenes (pLADD) Immunotherapy in Adults With Metastatic Colorectal Cancer",TERMINATED,,PHASE1,28.0,ACTUAL,"Aduro Biotech, Inc.",,1.0,,Study terminated due to business realignment,f,,,,,t,f,,,,,,,,,,,2024-10-15 11:03:23.01947,2024-10-15 11:03:23.01947,INDUSTRY,,,,,,,2020,0.0
NCT04601883,,2020-10-12,,,2023-02-14,2020-10-20,2020-10-26,ACTUAL,,,,,,,2023-02-14,2023-02-15,ACTUAL,2021-01-15,ACTUAL,2021-01-15,2023-02,2023-02-28,2022-08-03,ACTUAL,2022-08-03,2022-08-03,ACTUAL,2022-08-03,,INTERVENTIONAL,COLOR,,Colchicine as Treatment for People With Hand Osteoarthritis,"Colchicine Treatment for Patients With Hand Osteoarthritis: A Randomised, Placebo-controlled Trial.",COMPLETED,,PHASE4,100.0,ACTUAL,Frederiksberg University Hospital,,2.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,OTHER,,,,,,,2022,0.0
NCT03749616,,2018-09-26,2023-12-18,,2024-08-14,2018-11-19,2018-11-21,ACTUAL,2024-08-14,2024-09-05,ACTUAL,,,,2024-08-14,2024-09-05,ACTUAL,2019-01-02,ACTUAL,2019-01-02,2024-08,2024-08-31,2022-03-24,ACTUAL,2022-03-24,2022-03-24,ACTUAL,2022-03-24,,INTERVENTIONAL,Adult NSAID,,Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture,"Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture: A Prospective, Randomized Study",TERMINATED,,PHASE4,32.0,ACTUAL,University of Missouri-Columbia,,2.0,,Original principal investigator left the institution and investigator replacing him did not have the patient population to enroll as needed.,f,,,,,t,f,,,f,,,,,,,,2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,OTHER,,,,,,,2022,0.0
NCT04252287,,2020-01-31,2022-11-07,,2022-12-20,2020-01-31,2020-02-05,ACTUAL,2022-12-20,2023-01-12,ACTUAL,,,,2022-12-20,2023-01-12,ACTUAL,2020-03-10,ACTUAL,2020-03-10,2022-12,2022-12-31,2021-11-09,ACTUAL,2021-11-09,2021-11-09,ACTUAL,2021-11-09,,INTERVENTIONAL,CHIEF-HF,Safety analysis set included all randomized participants who received at least 1 dose of study intervention.,"A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure","Canagliflozin: Impact on Health Status, Quality of Life, and Functional Status in Heart Failure",COMPLETED,,PHASE3,476.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,INDUSTRY,,,,,,,2021,1.0
NCT05887479,,2023-04-09,,,2023-11-20,2023-05-24,2023-06-02,ACTUAL,,,,,,,2023-11-20,2023-11-22,ACTUAL,2023-05-25,ESTIMATED,2023-05-25,2023-11,2023-11-30,2023-08-15,ESTIMATED,2023-08-15,2023-07-15,ESTIMATED,2023-07-15,,INTERVENTIONAL,,,"The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity","The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity",WITHDRAWN,,PHASE4,0.0,ACTUAL,Sisli Hamidiye Etfal Training and Research Hospital,,2.0,,insufficient number of patients,f,,,,,f,f,,,,,,,,,,,2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,OTHER,,,,,,,2023,0.0
NCT03810690,,2019-01-14,,,2020-11-10,2019-01-16,2019-01-22,ACTUAL,,,,,,,2020-11-10,2020-11-13,ACTUAL,2019-05-28,ACTUAL,2019-05-28,2020-11,2020-11-30,2020-08-18,ACTUAL,2020-08-18,2020-08-18,ACTUAL,2020-08-18,,INTERVENTIONAL,,,Open Label Study of mRNA-3704 in Patients With Isolated Methylmalonic Acidemia,"A Global, Phase 1/2, Open Label, Dose Escalation Study to Evaluate the Safety, Pharmacodynamics, and Pharmacokinetics of mRNA-3704 in Patients With Isolated Methylmalonic Acidemia Due to Methylmalonyl-CoA Mutase Deficiency",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"ModernaTX, Inc.",,5.0,,Study was terminated before the start of dosing due to a business decision and not due to safety or efficacy reasons.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,INDUSTRY,,,,,,,2020,0.0
NCT04132388,,2019-09-13,,,2022-09-26,2019-10-16,2019-10-18,ACTUAL,,,,,,,2022-09-26,2022-09-29,ACTUAL,2020-08-20,ESTIMATED,2020-08-20,2022-09,2022-09-30,2022-09-07,ACTUAL,2022-09-07,2022-09-07,ACTUAL,2022-09-07,,INTERVENTIONAL,,,Hidradenitis Suppurativa Patient Experience With Humira Treatment,Hidradenitis Suppurativa Patients' Experience of Treatment With Adalimumab,WITHDRAWN,,PHASE4,0.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,Sponsor and site agreed the research would not happen now; several delays and other issues,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,OTHER,,,,,,,2022,0.0
NCT02135419,,2014-05-08,2022-07-25,,2024-07-18,2014-05-08,2014-05-12,ESTIMATED,2022-11-08,2022-12-02,ACTUAL,,,,2024-07-18,2024-07-26,ACTUAL,2014-09-24,ACTUAL,2014-09-24,2024-07,2024-07-31,2024-03-31,ACTUAL,2024-03-31,2021-08-06,ACTUAL,2021-08-06,,INTERVENTIONAL,ANCHOR,Participants who were randomized and received assigned intervention,Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions,ANCHOR Study: Anal Cancer/HSIL Outcomes Research Study,COMPLETED,,PHASE3,4446.0,ACTUAL,AIDS Malignancy Consortium,,2.0,,,f,,,,t,t,t,,,f,,,"IPD will only be shared with external investigators following conclusion of all participant data collection and the acceptance of a manuscript(s) that addresses all trial objectives, via release of the data to a public data repository, anticipated to occur on or after August 2025. Data will be available according to the archival terms of the AMC Data Commons.","Qualified researchers with plans approved by the AMC Executive Committee who have entered into a Data Use Agreement (DUA) with the AMC will be granted data access. Research plans may include, but are not limited to, research on HIV/AIDS, anal HSIL screening and/or treatment, HPV-associated malignancies, anal cancer, and associated conditions.",,YES,"A CDISC-mapped, de-identified version of the study data with appropriate documentation (data dictionary, annotated static copies of electronic case report forms, clinical protocol, informed consent document) of the data elements will be made available via a public data repository: the AIDS Malignancy Consortium (AMC) Data Commons.",2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,NETWORK,,,,,,,2024,1.0
NCT04369547,,2020-04-27,,,2021-12-23,2020-04-29,2020-04-30,ACTUAL,,,,,,,2021-12-23,2021-12-28,ACTUAL,2022-01,ESTIMATED,2022-01-31,2021-12,2021-12-31,2023-09-01,ESTIMATED,2023-09-01,2023-09-01,ESTIMATED,2023-09-01,,INTERVENTIONAL,,,Roflumilast TMS-EEG Plasticity,A Double-blind Placebo-controlled Crossover Study of Roflumilast Synaptic Plasticity Enhancement: a TMS-EEG Study,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Calgary,,2.0,,Resource limitations,f,,,,f,f,f,,,f,,,,,,NO,There will be no sharing of individual participant data.,2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,OTHER,,,,,,,2023,0.0
NCT04374253,,2020-05-01,2024-03-04,,2024-04-12,2020-05-04,2020-05-05,ACTUAL,2024-04-12,2024-05-08,ACTUAL,,,,2024-04-12,2024-05-08,ACTUAL,2021-01-26,ACTUAL,2021-01-26,2024-04,2024-04-30,2023-03-06,ACTUAL,2023-03-06,2023-03-06,ACTUAL,2023-03-06,,INTERVENTIONAL,,"ITT analysis set included all enrolled participants, who received at least one dose of study drug. Participants were analyzed by the treatment they were randomized to in the parent studies (GRADUATE I or GRADUATE II).","A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)","An Open-Label, Multicenter, Rollover Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease",TERMINATED,,PHASE3,1382.0,ACTUAL,Hoffmann-La Roche,,2.0,,Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early-stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I\&II (WN29922/WN39658).,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,INDUSTRY,,,,,,,2023,0.0
NCT04374019,,2020-05-01,2022-01-12,,2022-01-18,2020-05-01,2020-05-05,ACTUAL,2022-01-18,2022-01-20,ACTUAL,,,,2022-01-18,2022-01-20,ACTUAL,2020-05-01,ACTUAL,2020-05-01,2022-01,2022-01-31,2022-01-12,ACTUAL,2022-01-12,2020-12-21,ACTUAL,2020-12-21,,INTERVENTIONAL,,,Novel Agents for Treatment of High-risk COVID-19 Positive Patients,"Randomized, Multi-arm Phase II Trial of Novel Agents for Treatment of High-risk COVID-19 Positive Patients",TERMINATED,,PHASE2,13.0,ACTUAL,University of Kentucky,Thsi study was closed to accrual due to slow accrual rate. No conclusions on efficacy can be made due to a lack of statistical power in each arm.,4.0,,"slow accrual,",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,OTHER,,,,,,,2022,0.0
NCT03785691,,2018-11-13,,,2023-01-26,2018-12-20,2018-12-24,ACTUAL,,,,,,,2023-01-26,2023-01-30,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2023-01,2023-01-31,2022-07-31,ACTUAL,2022-07-31,2022-07-31,ACTUAL,2022-07-31,,INTERVENTIONAL,VOMIT,,Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum,Validating the Effect of Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum: A Double-Blind Randomised Placebo-Controlled Multicentre Trial,TERMINATED,,PHASE2,58.0,ACTUAL,Nordsjaellands Hospital,,3.0,,Recruiting difficulties,f,,,,t,f,f,,,f,,,"Following publication, no end date.",,,YES,Access to patient level data and supporting clinical documents may be requested. Requests will be reviewed on the basis of methodological proposal. Patient data will be de-identified to protect the privacy of trial patients in line with applicable laws and regulations.,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,OTHER,,,,,,,2022,0.0
NCT03320642,,2017-10-16,,,2022-04-29,2017-10-20,2017-10-25,ACTUAL,,,,,,,2022-04-29,2022-05-02,ACTUAL,2018-02-27,ACTUAL,2018-02-27,2022-04,2022-04-30,2022-02-17,ACTUAL,2022-02-17,2021-02-25,ACTUAL,2021-02-25,,INTERVENTIONAL,,,GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease,"GRAVITAS-119: A Single-Arm, Open-Label, Phase 1 Study of Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease",TERMINATED,,PHASE1,84.0,ACTUAL,Incyte Corporation,,1.0,,Study terminated by sponsor,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,INDUSTRY,,,,,,,2022,0.0
NCT05769959,,2023-03-03,,,2024-07-08,2023-03-03,2023-03-15,ACTUAL,,,,,,,2024-07-08,2024-07-09,ACTUAL,2023-06-15,ACTUAL,2023-06-15,2024-07,2024-07-31,2024-03-19,ACTUAL,2024-03-19,2024-03-19,ACTUAL,2024-03-19,,INTERVENTIONAL,,,Study of RO7515629 in Participants With HLA-G Positive Solid Tumors,"An Open-Label, Multicenter, Phase 1 Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7515629 in Participants With Unresectable and/or Metastatic HLA-G Positive Solid Tumors",TERMINATED,,PHASE1,3.0,ACTUAL,Hoffmann-La Roche,,3.0,,"Sponsor decision (not related to safety, efficacy or quality).",f,,,,,t,f,,,,,,,,,NO,,2024-10-15 11:03:23.01947,2024-10-15 11:03:23.01947,INDUSTRY,,,,,,,2024,0.0
NCT04371952,,2020-04-27,,,2022-04-13,2020-04-30,2020-05-01,ACTUAL,,,,,,,2022-04-13,2022-04-20,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2022-04,2022-04-30,2021-02-01,ACTUAL,2021-02-01,2021-02-01,ESTIMATED,2021-02-01,,INTERVENTIONAL,DYNAMIC,,DYNAMIC Study (DoxycYcliNe AMbulatoIre COVID-19),"Doxycycline Versus Placebo in COVID-19 + Patients Without Hospitalization Criteria: Prospective, Multicenter, Randomized, Double-blind Study",WITHDRAWN,,PHASE3,0.0,ACTUAL,Nantes University Hospital,,2.0,,"withdrawal due to the evolution of the epidemic, the arrival of vaccination and because the associated centres could no longer commit to the number of inclusions requested",f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,OTHER,,,,,,,2021,0.0
NCT04311177,,2020-03-13,2022-03-16,,2022-05-02,2020-03-13,2020-03-17,ACTUAL,2022-05-02,2022-05-04,ACTUAL,,,,2022-05-02,2022-05-04,ACTUAL,2020-04-09,ACTUAL,2020-04-09,2022-05,2022-05-31,2021-02-01,ACTUAL,2021-02-01,2021-02-01,ACTUAL,2021-02-01,,INTERVENTIONAL,,,Losartan for Patients With COVID-19 Not Requiring Hospitalization,Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization,COMPLETED,,PHASE2,117.0,ACTUAL,University of Minnesota,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,OTHER,,,,,,,2021,0.0
NCT03953261,,2019-05-14,,,2022-08-03,2019-05-14,2019-05-16,ACTUAL,,,,,,,2022-08-03,2022-08-05,ACTUAL,2019-09-01,ACTUAL,2019-09-01,2022-08,2022-08-31,2022-04-13,ACTUAL,2022-04-13,2022-04-13,ACTUAL,2022-04-13,,INTERVENTIONAL,,,Effect of Curcumin on Systemic Lupus Erythematosus,Effect of Curcumin on Systemic Lupus Erythematosus,TERMINATED,,PHASE2,23.0,ACTUAL,Loma Linda University,,2.0,,COVID and lack of support staff 2. lack of support staff to conduct the study,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,OTHER,,,,,,,2022,0.0
NCT03168464,,2017-05-19,2023-01-11,,2023-03-31,2017-05-25,2017-05-30,ACTUAL,2023-03-31,2023-04-24,ACTUAL,,,,2023-03-31,2023-04-24,ACTUAL,2017-10-09,ACTUAL,2017-10-09,2023-03,2023-03-31,2022-03-11,ACTUAL,2022-03-11,2022-03-11,ACTUAL,2022-03-11,,INTERVENTIONAL,,,Radiation and Immune Checkpoints Blockade in Metastatic NSCLC (BMS # CA209-632),Radiation and Immune Checkpoints Blockade in Metastatic NSCLC (BMS # CA209-632),TERMINATED,,PHASE1/PHASE2,15.0,ACTUAL,Weill Medical College of Cornell University,The study was terminated early leading to small numbers of subjects analyzed.,1.0,,Slow accrual,f,,,,t,t,t,,,f,,,,,,NO,,2024-10-15 11:03:23.01947,2024-10-15 11:03:23.01947,OTHER,,,,,,,2022,0.0
NCT04402008,,2020-05-21,2024-05-29,,2024-05-29,2020-05-22,2020-05-26,ACTUAL,2024-05-29,2024-06-25,ACTUAL,,,,2024-05-29,2024-06-25,ACTUAL,2020-06-23,ACTUAL,2020-06-23,2024-05,2024-05-31,2023-02-15,ACTUAL,2023-02-15,2023-02-15,ACTUAL,2023-02-15,,INTERVENTIONAL,,"Safety population included all participants who signed informed consent, enrolled and received at least 1 dose of poziotinib.",Study of Poziotinib in Japanese Patients With NSCLC,A Phase 1/2 Dose Finding Study of Poziotinib in Japanese Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC),TERMINATED,,PHASE1/PHASE2,42.0,ACTUAL,"Spectrum Pharmaceuticals, Inc",The study was prematurely terminated for business reasons and not related to safety.,3.0,,"Business decision, not related to safety.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,INDUSTRY,,,,,,,2023,0.0
NCT03710044,,2018-10-16,,,2019-07-09,2018-10-16,2018-10-17,ACTUAL,,,,,,,2019-07-09,2019-07-11,ACTUAL,2019-08,ESTIMATED,2019-08-31,2019-07,2019-07-31,2020-08,ESTIMATED,2020-08-31,2020-08,ESTIMATED,2020-08-31,,INTERVENTIONAL,,,Investigation of Flare and Remission in Subjects With Atopic Dermatitis,Investigation of Flare and Remission in Atopic Dermatitis in an Integrated Longitudinal Trial: Effects of Systemic Treatment With Cyclosporine A,WITHDRAWN,,PHASE4,0.0,ACTUAL,LEO Pharma,,1.0,,Strategic decision,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 11:03:23.01947,2024-10-15 11:03:23.01947,INDUSTRY,,,,,,,2020,0.0
NCT03770299,,2018-12-07,,,2022-03-09,2018-12-07,2018-12-10,ACTUAL,,,,,,,2022-03-09,2022-03-24,ACTUAL,2021-01-15,ESTIMATED,2021-01-15,2022-03,2022-03-31,2024-03-14,ESTIMATED,2024-03-14,2023-03-14,ESTIMATED,2023-03-14,,INTERVENTIONAL,CheckMate 9TN,,An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease,A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention With Adjuvant Nivolumab in Non-Small Cell Lung Cancer Participants With ctDNA-detected Minimal Residual Disease After Surgical Resection,WITHDRAWN,,PHASE2,0.0,ACTUAL,Bristol-Myers Squibb,,2.0,,Business objectives have changed,f,,,,f,t,f,,,,,,,,,YES,"Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html",2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,INDUSTRY,,,,,,,2024,0.0
NCT04466917,,2020-07-07,,,2023-06-28,2020-07-07,2020-07-10,ACTUAL,,,,,,,2023-06-28,2023-07-03,ACTUAL,2021-05-15,ESTIMATED,2021-05-15,2021-05,2021-05-31,2022-11-13,ESTIMATED,2022-11-13,2022-11-13,ESTIMATED,2022-11-13,,INTERVENTIONAL,,,A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer,"A Randomized, Double-blind, Phase 3 Bridging Study Evaluating the Safety and Efficacy of ABP 215 Compared With Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer",WITHDRAWN,,PHASE3,0.0,ACTUAL,Amgen,,2.0,,Sponsor decision to early terminate the study,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,INDUSTRY,,,,,,,2022,0.0
NCT03302585,,2017-09-27,,,2024-07-22,2017-09-30,2017-10-05,ACTUAL,,,,,,,2024-07-22,2024-07-24,ACTUAL,2017-11-23,ACTUAL,2017-11-23,2024-07,2024-07-31,2024-05-09,ACTUAL,2024-05-09,2024-05-09,ACTUAL,2024-05-09,,INTERVENTIONAL,VitaDON2,,High-Dose Vitamin D Induction in Optic Neuritis,A Phase II Trial of High-Dose Vitamin D Induction in Optic Neuritis (VitaDON 2),TERMINATED,,PHASE2,12.0,ACTUAL,University of Calgary,,2.0,,inability to meet recruitment goals,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 11:03:23.01947,2024-10-15 11:03:23.01947,OTHER,,,,,,,2024,0.0
NCT02825719,,2016-05-29,,,2020-04-07,2016-07-01,2016-07-07,ESTIMATED,,,,,,,2020-04-07,2020-04-09,ACTUAL,2015-12-02,ACTUAL,2015-12-02,2020-04,2020-04-30,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,,Ulipristal Use in Chinese Population,Pilot Study on the Pre-operative Use of Ulipristal on Fibroid in Chinese Population,TERMINATED,,PHASE4,31.0,ACTUAL,"Queen Mary Hospital, Hong Kong",,2.0,,Ulipristal was withdrawal from the market,f,,,,f,,,,,,,,,,,NO,This is to protect the privacy of individual patients,2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,OTHER,,,,,,,2020,0.0
NCT04223661,,2019-12-03,,,2022-12-06,2020-01-07,2020-01-10,ACTUAL,,,,,,,2022-12-06,2022-12-08,ACTUAL,2021-12-06,ESTIMATED,2021-12-06,2022-12,2022-12-31,2023-12-31,ESTIMATED,2023-12-31,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,"Frailty Score-guided Dosing of Lenalidomide, Dexamethasone and Daratumumab Induction Therapy","Frailty Score-guided Dosing of Lenalidomide, Dexamethasone and Daratumumab Induction Therapy in Elderly, Frail Newly Diagnosed Myeloma (MMY2035)",WITHDRAWN,,PHASE2,0.0,ACTUAL,Indiana University,,2.0,,lack of funding,f,,,,t,t,f,,,,,,,,,,,2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,OTHER,,,,,,,2023,0.0
NCT04753164,,2021-02-09,2023-03-06,,2023-03-30,2021-02-09,2021-02-15,ACTUAL,2023-03-30,2023-03-31,ACTUAL,,,,2023-03-30,2023-03-31,ACTUAL,2021-02-16,ACTUAL,2021-02-16,2023-03,2023-03-31,2022-03-25,ACTUAL,2022-03-25,2022-03-21,ACTUAL,2022-03-21,,INTERVENTIONAL,,Randomized population,Multicenter Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder,"Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Proof-of-concept Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder",COMPLETED,,PHASE2,136.0,ACTUAL,Idorsia Pharmaceuticals Ltd.,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 11:03:23.01947,2024-10-15 11:03:23.01947,INDUSTRY,,,,,,,2022,1.0
NCT04047563,,2019-08-05,,,2023-10-16,2019-08-05,2019-08-06,ACTUAL,,,,,,,2023-10-16,2023-10-18,ACTUAL,2019-11-10,ACTUAL,2019-11-10,2023-10,2023-10-31,2022-02-10,ACTUAL,2022-02-10,2022-02-10,ACTUAL,2022-02-10,,INTERVENTIONAL,,,Efficacy of Sovateltide (PMZ-1620) in Patients of Acute Ischemic Stroke,"A Prospective, Multicentric, Randomized, Double-blind, Parallel, Phase III Clinical Study to Assess Efficacy of PMZ-1620 Along With Standard Treatment in Patients of Acute Ischemic Stroke",COMPLETED,,PHASE3,158.0,ACTUAL,"Pharmazz, Inc.",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,Results will be communicated and published as manuscript,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,INDUSTRY,,,,,,,2022,1.0
NCT03227432,,2017-07-07,,,2018-08-10,2017-07-21,2017-07-24,ACTUAL,,,,,,,2018-08-10,2018-08-14,ACTUAL,2018-12,ESTIMATED,2018-12-31,2018-08,2018-08-31,2024-12-31,ESTIMATED,2024-12-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,An Exploratory Study to Evaluate the Combination of Elotuzumab and Nivolumab With and Without Pomalidomide in Relapsed Refractory Multiple Myeloma,An Exploratory Study to Evaluate the Combination of Elotuzumab and Nivolumab With and Without Pomalidomide in Relapsed Refractory Multiple Myeloma,WITHDRAWN,,PHASE2,0.0,ACTUAL,Dana-Farber Cancer Institute,,2.0,,Withdrawn before enrollment due to issues around the FDA hold on PD-1/PD-L1 drugs in combination with IMIDs.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,OTHER,,,,,,,2024,0.0
NCT05067972,,2021-09-24,,,2024-04-19,2021-09-24,2021-10-05,ACTUAL,,,,,,,2024-04-19,2024-04-22,ACTUAL,2021-10-07,ACTUAL,2021-10-07,2024-04,2024-04-30,2023-10-17,ACTUAL,2023-10-17,2023-10-17,ACTUAL,2023-10-17,,INTERVENTIONAL,C4431001,,A Study of PF-07260437 in Advanced or Metastatic Solid Tumors,"A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTITUMOR ACTIVITY OF PF-07260437 IN ADVANCED OR METASTATIC SOLID TUMORS",TERMINATED,,PHASE1,30.0,ACTUAL,Pfizer,,4.0,,Pfizer has made an internal business decision to not continue further development of PF-07260437. This decision was not due to major safety concerns or requests from any regulatory authorities.,,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,INDUSTRY,,,,,,,2023,0.0
NCT03201952,,2017-06-22,,,2021-04-18,2017-06-26,2017-06-28,ACTUAL,,,,,,,2021-04-18,2021-04-20,ACTUAL,2018-02-01,ACTUAL,2018-02-01,2021-04,2021-04-30,2020-05-01,ACTUAL,2020-05-01,2020-05-01,ACTUAL,2020-05-01,,INTERVENTIONAL,,,Examination of the Metabolic Effects of Direct Bile Salt Delivery to the Ileum in Humans,Examination of the Metabolic Effects of Direct Bile Salt Delivery to the Ileum in Humans,TERMINATED,,PHASE1,2.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,Difficulty in participant recruitment,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,OTHER,,,,,,,2020,0.0
NCT03257631,,2017-08-18,2019-11-22,,2024-04-12,2017-08-18,2017-08-22,ACTUAL,2019-11-22,2019-12-10,ACTUAL,,,,2024-04-12,2024-04-16,ACTUAL,2017-09-18,ACTUAL,2017-09-18,2024-04,2024-04-30,2023-09-14,ACTUAL,2023-09-14,2023-09-14,ACTUAL,2023-09-14,,INTERVENTIONAL,,"The intent-to-treat population includes all enrolled participants, regardless of whether they received any treatment or not",A Study of Pomalidomide Monotherapy for Children and Young Adults With Recurrent or Progressive Primary Brain Tumors,A PHASE 2 CLINICAL STUDY OF POMALIDOMIDE (CC-4047) MONOTHERAPY FOR CHILDREN AND YOUNG ADULTS WITH RECURRENT OR PROGRESSIVE PRIMARY BRAIN TUMORS,COMPLETED,,PHASE2,53.0,ACTUAL,Celgene,,1.0,,,t,,,,t,t,f,,,,,,,,,,,2024-10-15 11:03:23.01947,2024-10-15 11:03:23.01947,INDUSTRY,,NCT03723096,NO_LONGER_AVAILABLE,,,,2023,0.0
NCT03945799,,2019-05-09,,,2022-08-25,2019-05-09,2019-05-10,ACTUAL,,,,,,,2022-08-25,2022-08-31,ACTUAL,2019-04-22,ACTUAL,2019-04-22,2022-08,2022-08-31,2022-06-25,ACTUAL,2022-06-25,2022-06-25,ACTUAL,2022-06-25,,INTERVENTIONAL,,,A Multicenter Study of Anlotinib in Hepatocellular Carcinoma (HCC) Patients at High Risk of Post Surgery Recurrence,"A Single Group, Open Label, Multi-center Clinical Study to Assess the Efficacy and Safety of Anlotinib in HCC Patients at High Risk of Post Surgery Recurrence.",TERMINATED,,PHASE1/PHASE2,28.0,ACTUAL,Zhejiang University,,1.0,,The study has gotten preliminary results and stopped advanced.,f,,,,,f,f,,,,,,,,,YES,,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,OTHER,,,,,,,2022,0.0
NCT02911935,,2016-09-18,2022-04-18,,2022-06-06,2016-09-20,2016-09-22,ESTIMATED,2022-06-06,2022-06-07,ACTUAL,,,,2022-06-06,2022-06-07,ACTUAL,2016-11,ACTUAL,2016-11-30,2022-06,2022-06-30,2021-04,ACTUAL,2021-04-30,2021-04,ACTUAL,2021-04-30,,INTERVENTIONAL,APW-RSV-II,,Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II,Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II,COMPLETED,,PHASE2/PHASE3,200.0,ACTUAL,Washington University School of Medicine,"1. Our ultimate goal was to examine an asthma prevention strategy. However, the primary outcome was defined as recurrent wheeze during 2-4 years of follow-up. This was previously done in other studies in this field.~2. The study primary outcome measure was wheeze assessed by the parents, which has a relatively low correlation with wheeze assessed by physicians. However, a systematic bias is unlikely as both groups were evaluated by the same method",2.0,,,f,,,,t,,,,,,,,A month after publication,See above,,YES,"Qualified researchers may request access to study documents, including the study protocol with any amendments and blank case report forms.~Upon reasonable request, these data will be provided by Dr. Charles Goss, the study statistician. email: cwgoss@wustl.edu",2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,OTHER,,,,,,,2021,1.0
NCT03282799,,2017-09-12,2024-03-14,,2024-08-30,2017-09-13,2017-09-14,ACTUAL,2024-08-30,2024-09-05,ACTUAL,,,,2024-08-30,2024-09-05,ACTUAL,2019-02-19,ACTUAL,2019-02-19,2024-08,2024-08-31,2022-10-25,ACTUAL,2022-10-25,2020-12-22,ACTUAL,2020-12-22,,INTERVENTIONAL,,All enrolled participants,Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women,Pharmacokinetic and Pharmacodynamic Evaluation of Etonogestrel Dose Escalation With Efavirenz-based Antiretroviral Therapy in HIV-infected Ugandan,COMPLETED,,PHASE2,72.0,ACTUAL,University of Pittsburgh,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,OTHER,,,,,,,2022,1.0
NCT05225558,,2022-01-26,,,2024-05-13,2022-01-26,2022-02-04,ACTUAL,,,,,,,2024-05-13,2024-05-16,ACTUAL,2022-04-26,ACTUAL,2022-04-26,2024-01,2024-01-31,2024-02-16,ACTUAL,2024-02-16,2024-02-16,ACTUAL,2024-02-16,,INTERVENTIONAL,,,"A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With MRSA Bacteremia","A Multicenter, Double-blinded, Randomized, Parallel Design, Phase IIa Clinical Trial to Evaluate the Efficacy, Safety and PK of LCB01-0371 With Vancomycin Versus Vancomycin Monotherapy in Patients With MRSA Bacteremia",TERMINATED,,PHASE2,40.0,ACTUAL,"LigaChem Biosciences, Inc.",,2.0,,Early termination; Difficulties in enrolling subjects due to the decrease in patients with MRSA bacteremia,f,,,,t,t,f,,,,,,IPD will be provided 1-2 years after and up to 5 years after the publication of the article on the results of the trial.,IPD access will be provided for analyses of the related to the aims of research described in the protocol and for individual patient data meta analyses to researches who provide a methodologically sound proposal to lcb_pv@legochembio.com,,YES,"Deidentified individual patient data, that underlie the results in published article(s) based on data from the trial which including text, tables, figures will be presented to various stakeholders. This reported will be presented to various stakeholder during various forums or meetings. First results will be disclosed to participants, staff and our site Community Advisory Board. Thereafter we would invite several stakeholders from the community or visit their establishments to review study results. Simultaneously, the studying findings report will be sent to the various regulatory authorities, including the National Department of Health (NDoH). With NDoH and its divisions we will establish needs for further engagement and suggestions for policy or programmatic changes.",2024-10-15 11:03:23.01947,2024-10-15 11:03:23.01947,INDUSTRY,,,,,,,2024,0.0
NCT04155008,,2019-10-31,2022-09-28,,2022-10-24,2019-11-04,2019-11-07,ACTUAL,2022-10-24,2022-11-16,ACTUAL,,,,2022-10-24,2022-11-16,ACTUAL,2021-03-01,ACTUAL,2021-03-01,2022-10,2022-10-31,2021-04-05,ACTUAL,2021-04-05,2021-04-05,ACTUAL,2021-04-05,,INTERVENTIONAL,,Only 1 participant was enrolled in this study.,Nutrition and Pharmacological Algorithm for Oncology Patients Study,Assessing Quality of Life and the Feasibility of a Nutrition and Pharmacological Algorithm for Oncology Patients With Anorexia,TERMINATED,,PHASE4,1.0,ACTUAL,Montefiore Medical Center,The primary and secondary outcomes were unable to be assessed as only 1 patient (out of a planned 30) was enrolled into the study. No analyses were therefore conducted.,2.0,,The trial was closed after 4 months due to slow to accrual. Only 1 participant was enrolled.,f,,,,,t,f,,,t,,,,,,NO,,2024-10-15 11:03:23.01947,2024-10-15 11:03:23.01947,OTHER,,,,,,,2021,0.0
NCT04142619,,2019-10-25,,,2023-09-21,2019-10-28,2019-10-29,ACTUAL,,,,,,,2023-09-21,2023-09-22,ACTUAL,2019-11-21,ACTUAL,2019-11-21,2023-09,2023-09-30,2023-06-18,ACTUAL,2023-06-18,2023-06-18,ACTUAL,2023-06-18,,INTERVENTIONAL,,,Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01),"Phase I, Open-label Dose-escalation Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCARTCS1A (Allogenic Engineered T-cells Expressing Anti-CS1 Chimeric Antigen Receptor) Administered in Patients With Relapsed/Refractory Multiple Myeloma",TERMINATED,,PHASE1,11.0,ACTUAL,Cellectis S.A.,,1.0,,The trial was discontinued due to sponsor's decision and not a consequence of any safety concern.,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,INDUSTRY,,,,,,,2023,0.0
NCT01961804,,2013-10-09,,,2021-04-26,2013-10-10,2013-10-11,ESTIMATED,,,,,,,2021-04-26,2021-04-27,ACTUAL,2014-03,ACTUAL,2014-03-31,2020-08,2020-08-31,2020-09-03,ACTUAL,2020-09-03,2020-02-28,ACTUAL,2020-02-28,,INTERVENTIONAL,PREVACT,,PREVACT : Preventive REversal of Vitamine K Antagonist in Minor Craniocerebral Trauma,Phase 3 Study Comparing Preventive Reversal of Vitamine K Antagonist Versus Reversion Only in Case of Intracranial Bleeding in Patients Receiving Vitamine K Antagonist Treatment,TERMINATED,,PHASE3,202.0,ACTUAL,"University Hospital, Angers",,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,OTHER_GOV,,,,,,,2020,0.0
NCT04398199,,2020-05-18,2022-08-10,,2022-09-26,2020-05-18,2020-05-21,ACTUAL,2022-09-26,2022-10-05,ACTUAL,,,,2022-09-26,2022-10-05,ACTUAL,2020-10-16,ACTUAL,2020-10-16,2022-09,2022-09-30,2020-11-20,ACTUAL,2020-11-20,2020-11-20,ACTUAL,2020-11-20,,INTERVENTIONAL,,,Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients,A Single Arm Phase II Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients Who Decline or Are Ineligible for Surgery or Chemotherapy,TERMINATED,,PHASE2,1.0,ACTUAL,Wake Forest University Health Sciences,"One patient was accrued to this trial. He was assigned to the intervention arm. He began on study on 10/16/2020, and began treatment on 10/19/2020. He went off treatment 11/20/2020 due to a fall-he did not return for follow-up after week 3. He expired on 1/8/2021. The study was terminated early due to slow accruals which did not allow enough time for data collection for any outcome measures to properly assess the clinical trial.",1.0,,Low accruals,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,OTHER,,,,,,,2020,0.0
NCT04944888,,2021-06-23,,,2023-12-18,2021-06-28,2021-06-30,ACTUAL,,,,,,,2023-12-18,2023-12-19,ACTUAL,2021-07-01,ACTUAL,2021-07-01,2023-12,2023-12-31,2023-11-30,ACTUAL,2023-11-30,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,,,GSL Synthetase Inhibitor in Combination With Immune Checkpoint Inhibitor in Previously Treated Blood and Solid Tumor,Phase ⅠStudy of GSL Synthetase Inhibitor in Combination With Immune Checkpoint Inhibitor in Treating Patients With Advanced Relapsed or Refractory Hematological Malignancies and Previously Treated Solid Tumors,COMPLETED,,PHASE1,31.0,ACTUAL,Chinese PLA General Hospital,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,OTHER,,,,,,,2023,1.0
NCT05683860,,2023-01-04,,,2023-10-18,2023-01-04,2023-01-13,ACTUAL,,,,,,,2023-10-18,2023-10-23,ACTUAL,2022-12-14,ACTUAL,2022-12-14,2023-01,2023-01-31,2023-06-30,ACTUAL,2023-06-30,2023-06-30,ACTUAL,2023-06-30,,INTERVENTIONAL,,,Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD),"A Multicenter, Open-label Extension (OLE) Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)",TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,Wave Life Sciences Ltd.,,1.0,,"Despite robust, sustained reductions in poly(GP), no clinical benefit was seen at 24 weeks, and reductions in poly(GP) were not associated with stabilization in functional outcomes. Based on these data, Wave decided to stop development of WVE-004.",f,,,,t,t,f,,,t,,,,,,,,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,INDUSTRY,,,,,,,2023,0.0
NCT04438850,,2020-04-10,,,2021-06-17,2020-06-18,2020-06-19,ACTUAL,,,,,,,2021-06-17,2021-06-23,ACTUAL,2020-07-31,ACTUAL,2020-07-31,2021-06,2021-06-30,2021-06-08,ACTUAL,2021-06-08,2021-06-08,ACTUAL,2021-06-08,,INTERVENTIONAL,COVER,,COVidIVERmectin: Ivermectin for Treatment of Covid-19,"Randomized, Double-blind, Multi Centre Phase II, Proof of Concept, Dose Finding Clinical Trial on Ivermectin for the Early Treatment of COVID-19",TERMINATED,,PHASE2,93.0,ACTUAL,IRCCS Sacro Cuore Don Calabria di Negrar,,3.0,,Incidence has dramatically dropped and there is lack of eligible patients,f,,,,t,f,f,,,f,,,The database will be available upon publication of the results,The data will be available in a public repository,,YES,The anonymized database will be uploaded into a public repository,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,OTHER,,,,,,,2021,0.0
NCT03794037,,2019-01-02,,,2022-09-18,2019-01-03,2019-01-04,ACTUAL,,,,,,,2022-09-18,2022-09-21,ACTUAL,2018-12-05,ACTUAL,2018-12-05,2022-09,2022-09-30,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Montelukast for Prevention & Treatment of OHSS,Montelukast for Prevention & Treatment of Ovarian Hyperstimulation Syndrome in Freeze-all Cycles,SUSPENDED,,PHASE2,20.0,ESTIMATED,Benha University,,2.0,,no fund,f,,,,t,f,f,,,,,,6 months,drahmedsaad@live.com,,YES,"study protocol, results,statistics",2024-10-15 11:03:23.01947,2024-10-15 11:03:23.01947,OTHER,,,,,,,2023,0.0
NCT02662985,,2016-01-13,2021-11-08,,2021-11-08,2016-01-20,2016-01-26,ESTIMATED,2021-11-08,2021-12-07,ACTUAL,,,,2021-11-08,2021-12-07,ACTUAL,2016-08-22,ACTUAL,2016-08-22,2021-11,2021-11-30,2020-11-10,ACTUAL,2020-11-10,2020-11-10,ACTUAL,2020-11-10,,INTERVENTIONAL,PDUS,,Study of Power Doppler Ultrasound (PDUS) to Measure Response of Secukinumab Treatment in Patients With Active Psoriatic Arthritis (PsA),"A 52-week, Multicenter Study to Assess the Time Course of Response to Secukinumab on Joint Inflammation Using Power Doppler Ultrasonography in Patients With Active Psoriatic Arthritis",COMPLETED,,PHASE3,166.0,ACTUAL,Novartis,,2.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,INDUSTRY,,,,,,,2020,1.0
NCT03639766,,2018-08-17,2021-05-15,,2021-06-09,2018-08-17,2018-08-21,ACTUAL,2021-06-09,2021-06-30,ACTUAL,,,,2021-06-09,2021-06-30,ACTUAL,2018-08-31,ACTUAL,2018-08-31,2021-06,2021-06-30,2020-01-31,ACTUAL,2020-01-31,2020-01-31,ACTUAL,2020-01-31,,INTERVENTIONAL,,,The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon,"The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial",TERMINATED,,PHASE4,3.0,ACTUAL,University of Central Florida,,2.0,,Time and resource constraints,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,OTHER,,,,,,,2020,0.0
NCT05127122,,2021-11-09,,,2024-07-26,2021-11-09,2021-11-19,ACTUAL,,,,,,,2024-07-26,2024-07-29,ACTUAL,2024-12,ESTIMATED,2024-12-31,2024-07,2024-07-31,2024-12,ESTIMATED,2024-12-31,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,EXIT-ARDS,,Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for ARDS,Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for Acute Respiratory Distress Syndrome: A Phase I/II Clinical Trial,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Direct Biologics, LLC",,3.0,,Change in development plan,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,INDUSTRY,,,,,,,2024,0.0
NCT04694300,,2020-12-31,2024-03-13,,2024-05-07,2021-01-01,2021-01-05,ACTUAL,2024-05-07,2024-05-16,ACTUAL,,,,2024-05-07,2024-05-16,ACTUAL,2021-02-07,ACTUAL,2021-02-07,2024-05,2024-05-31,2022-08-28,ACTUAL,2022-08-28,2022-08-28,ACTUAL,2022-08-28,,INTERVENTIONAL,,,OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients,Demonstration of OTC Naproxen Sodium's (Aleve's) Anti-inflammatory Action in Dental Implant Surgery Patients,COMPLETED,,PHASE4,30.0,ACTUAL,"Hersh, Elliot V., DMD, MS, PhD","Research study as described in the results manuscript only evaluated 30 subjects but it is the first of it's kind. Our analysis was not powered to comprehensively evaluate the clinical and demographic factors that influence the local and systemic inflammatory response to implant placement surgery or drug response. In addition, we excluded smokers and patients with diabetes, autoimmune diseases, or other comorbidities that might influence the inflammatory response to implant placement surgery.",2.0,,,f,,,,f,t,f,,,t,,,,,,NO,"IPD will not be shared. This is a pilot, exploratory study.",2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,INDIV,,,,,,,2022,1.0
NCT05366439,,2022-05-05,,,2023-04-20,2022-05-05,2022-05-09,ACTUAL,,,,,,,2023-04-20,2023-04-21,ACTUAL,2022-04-22,ACTUAL,2022-04-22,2022-05,2022-05-31,2023-03-16,ACTUAL,2023-03-16,2023-03-16,ACTUAL,2023-03-16,,INTERVENTIONAL,,,Study of AT-752 in Healthy Subjects in a Dengue Human Challenge Model,"A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Assess the Antiviral Activity and Safety of AT-752 in a Dengue Human Challenge Model",TERMINATED,,PHASE1,5.0,ACTUAL,"Atea Pharmaceuticals, Inc.",,2.0,,Sponsor decision to deprioritize the dengue program,f,,,,f,t,f,,,,,,,,,,,2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,INDUSTRY,,,,,,,2023,0.0
NCT05294328,,2022-03-04,2024-08-14,,2024-08-14,2022-03-15,2022-03-24,ACTUAL,2024-08-14,2024-09-05,ACTUAL,,,,2024-08-14,2024-09-05,ACTUAL,2022-05-05,ACTUAL,2022-05-05,2024-08,2024-08-31,2022-09-10,ACTUAL,2022-09-10,2022-08-22,ACTUAL,2022-08-22,,INTERVENTIONAL,,,Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia,"A Multicenter, Double-Masked Evaluation of the Safety and Effectiveness of Aceclidine /Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia",COMPLETED,,PHASE2,68.0,ACTUAL,"LENZ Therapeutics, Inc",,3.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 21:55:41.383231,2024-10-15 21:55:41.383231,OTHER,,,,,,,2022,1.0
NCT04314843,,2020-03-17,2023-07-17,,2023-07-17,2020-03-17,2020-03-19,ACTUAL,2023-07-17,2024-03-04,ACTUAL,,,,2023-07-17,2024-03-04,ACTUAL,2020-05-26,ACTUAL,2020-05-26,2023-07,2023-07-31,2022-07-27,ACTUAL,2022-07-27,2021-03-16,ACTUAL,2021-03-16,,INTERVENTIONAL,ZUMA-19,The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel and/or any dose of lenzilumab.,Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma,"A Phase 1/2 Open-label, Multicenter Study of Lenzilumab and Axicabtagene Ciloleucel in Subjects With Relapsed or Refractory Large B-cell Lymphoma (ZUMA-19)",TERMINATED,,PHASE1,6.0,ACTUAL,Gilead Sciences,,1.0,,Development program terminated and the decision was not due to any safety concerns.,f,,,,f,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gileadclinicaltrials.com/transparency-policy/,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/",2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,INDUSTRY,,,,,,,2022,0.0
NCT04012099,,2018-12-03,,,2023-05-22,2019-07-04,2019-07-09,ACTUAL,,,,,,,2023-05-22,2023-05-24,ACTUAL,2019-08-21,ACTUAL,2019-08-21,2022-07,2022-07-31,2023-05-10,ACTUAL,2023-05-10,2023-05-10,ACTUAL,2023-05-10,,INTERVENTIONAL,,,the Hypertrophic Scar Prevention of BMT101.,"An Independent Evaluator-Blind, Dose-Escalation, Untreated-Controlled, Within-Subject, Phase 2a Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of BMT 101 Administration for the Prevention of Hypertrophic Scar",TERMINATED,,PHASE2,20.0,ACTUAL,Hugel,,2.0,,Internal reasons,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,INDUSTRY,,,,,,,2023,0.0
NCT04332991,,2020-03-31,2021-02-09,,2021-03-12,2020-03-31,2020-04-03,ACTUAL,2021-03-12,2021-03-17,ACTUAL,,,,2021-03-12,2021-03-17,ACTUAL,2020-04-02,ACTUAL,2020-04-02,2021-03,2021-03-31,2020-07-23,ACTUAL,2020-07-23,2020-06-19,ACTUAL,2020-06-19,,INTERVENTIONAL,ORCHID,,Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease,Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease,COMPLETED,,PHASE3,479.0,ACTUAL,Massachusetts General Hospital,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,OTHER,,,,,,,2020,0.0
NCT03478865,,2018-03-15,2024-05-03,,2024-06-17,2018-03-24,2018-03-27,ACTUAL,2024-05-03,2024-05-31,ACTUAL,,,,2024-06-17,2024-07-09,ACTUAL,2018-04-20,ACTUAL,2018-04-20,2024-03,2024-03-31,2023-06-16,ACTUAL,2023-06-16,2023-06-16,ACTUAL,2023-06-16,,INTERVENTIONAL,,,Vitamin A Palmitate Supplementation in People With Age-Related Macular Degeneration (and Without Reticular Pseudodrusen) and Delayed Dark Adaptation,An Investigation of Vitamin A Palmitate Supplementation in Patients With Age-Related Macular Degeneration (and Without Reticular Pseudodrusen) and Delayed Dark Adaptation,COMPLETED,,EARLY_PHASE1,8.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,,f,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,NIH,,,,,,,2023,1.0
NCT05222178,,2021-12-21,,,2023-10-05,2022-02-01,2022-02-03,ACTUAL,,,,,,,2023-10-05,2023-10-10,ACTUAL,2022-06-03,ACTUAL,2022-06-03,2023-10,2023-10-31,2023-09-14,ACTUAL,2023-09-14,2023-09-14,ACTUAL,2023-09-14,,INTERVENTIONAL,,,Safety and Efficacy of HMI-103 in Participants With Classical PKU Due to PAH Deficiency,"A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of HMI-103 Administered Intravenously in Adult Participants With Classical PKU Due to PAH Deficiency",TERMINATED,,PHASE1,3.0,ACTUAL,"Homology Medicines, Inc",,3.0,,Homology Medicines Inc. has discontinued the development of this program.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,INDUSTRY,,,,,,,2023,0.0
NCT04271475,,2020-02-13,,,2024-02-01,2020-02-13,2020-02-17,ACTUAL,,,,,,,2024-02-01,2024-02-02,ACTUAL,2020-07-07,ACTUAL,2020-07-07,2024-02,2024-02-29,2023-12-21,ACTUAL,2023-12-21,2023-12-21,ACTUAL,2023-12-21,,INTERVENTIONAL,MACiTEPH,,A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension,"A Prospective, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Group, Adaptive Phase 3 Study With Open-label Extension to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension",TERMINATED,,PHASE3,127.0,ACTUAL,Actelion,,2.0,,The Sponsor decided to stop the study for futility based on a recommendation by the IDMC following a pre-planned interim analysis,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,INDUSTRY,,,,,,,2023,0.0
NCT01838174,,2013-04-18,,,2023-04-26,2013-04-18,2013-04-23,ESTIMATED,,,,,,,2023-04-26,2023-04-27,ACTUAL,2013-05,,2013-05-31,2023-04,2023-04-30,2022-01-13,ACTUAL,2022-01-13,2022-01-13,ACTUAL,2022-01-13,,INTERVENTIONAL,ACTHAR,,A Trial of Neuroprotection With ACTH in Acute Optic Neuritis,A Phase IV Trial of Neuroprotection With ACTH in Acute Optic Neuritis,TERMINATED,,PHASE4,37.0,ACTUAL,"University of Colorado, Denver",,2.0,,Sponsor requested,f,,,,f,,,,,,,,,,,NO,,2024-10-16 08:07:11.740113,2024-10-16 08:07:11.740113,OTHER,,,,,,,2022,0.0
NCT03288493,,2017-09-13,2023-04-25,,2024-03-26,2017-09-18,2017-09-20,ACTUAL,2023-05-26,2023-06-22,ACTUAL,,,,2024-03-26,2024-03-28,ACTUAL,2017-09-20,ACTUAL,2017-09-20,2024-03,2024-03-31,2022-04-27,ACTUAL,2022-04-27,2022-04-27,ACTUAL,2022-04-27,,INTERVENTIONAL,,,P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM),"Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P BCMA-101 in Subjects With Relapsed / Refractory Multiple Myeloma (MM) Followed by a Phase 2 Assessment of Response and Safety (PRIME)",TERMINATED,,PHASE1/PHASE2,105.0,ACTUAL,"Poseida Therapeutics, Inc.",,8.0,,Phase I portion of the study was completed. The phase II portion of the study was terminated early to focus on an Allogeneic BCMA CAR-T program.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,INDUSTRY,,,,,,,2022,0.0
NCT04033159,,2019-06-12,2023-03-23,,2023-06-02,2019-07-24,2019-07-25,ACTUAL,2023-06-02,2023-06-27,ACTUAL,,,,2023-06-02,2023-06-27,ACTUAL,2020-01-09,ACTUAL,2020-01-09,2023-06,2023-06-30,2022-06-22,ACTUAL,2022-06-22,2022-06-22,ACTUAL,2022-06-22,,INTERVENTIONAL,Unite-CNM,,Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies,"A Phase 1/2 Trial on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Exploratory Efficacy of DYN101 in Patients ≥ 16 Years of Age With Centronuclear Myopathies Caused by Mutations in DNM2 or MTM1.",TERMINATED,,PHASE1/PHASE2,14.0,ACTUAL,Dynacure,,3.0,,"Based on tolerability findings at the low dose level thus far, continuation of dosing or even dose escalation is not possible.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,INDUSTRY,,,,,,,2022,0.0
NCT03336216,,2017-11-06,2024-05-30,,2024-07-21,2017-11-06,2017-11-08,ACTUAL,2024-07-21,2024-07-23,ACTUAL,,,,2024-07-21,2024-07-23,ACTUAL,2017-12-18,ACTUAL,2017-12-18,2024-07,2024-07-31,2023-06-01,ACTUAL,2023-06-01,2023-06-01,ACTUAL,2023-06-01,,INTERVENTIONAL,,,A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer,"A Phase 2 Study of Cabiralizumab (BMS-986227, FPA008) Administered in Combination With Nivolumab (BMS-936558) With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer",COMPLETED,,PHASE2,205.0,ACTUAL,Bristol-Myers Squibb,,4.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,INDUSTRY,,,,,,,2023,0.0
NCT05886257,,2022-12-06,,,2023-06-01,2023-06-01,2023-06-02,ACTUAL,,,,,,,2023-06-01,2023-06-02,ACTUAL,2022-12-07,ACTUAL,2022-12-07,2022-12,2022-12-31,2023-03-31,ACTUAL,2023-03-31,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,,,Candonilimab Plus Bevacizumab for Patients With Advanced HCC Who Progressed on A+T,"Candonilimab Plus Bevacizumab as Second-line Treatment for Patients With Advanced Hepatocellular Carcinoma Who Progressed on Atezolizumab Plus Bevacizumab: a Single Arm, Phase 2 Trial",WITHDRAWN,,PHASE2,0.0,ACTUAL,Sun Yat-sen University,,1.0,,Protocol adjustment,f,,,,t,f,f,,,,,,,,,,,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,OTHER,,,,,,,2023,0.0
NCT03960151,,2018-03-26,,,2019-05-21,2019-05-21,2019-05-22,ACTUAL,,,,,,,2019-05-21,2019-05-22,ACTUAL,2018-05,ESTIMATED,2018-05-31,2019-05,2019-05-31,2022-03,ESTIMATED,2022-03-31,2021-05,ESTIMATED,2021-05-31,,INTERVENTIONAL,,,Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy,"Phase II Study of Rolapitant Plus Olanzapine, Palonosetron, and Dexamethasone in Patients With Germ Cell Tumors Undergoing 5-day Cisplatin-based Chemotherapy.",WITHDRAWN,,PHASE2,0.0,ACTUAL,Hoosier Cancer Research Network,,1.0,,Compound was sold by funder and development ceased.,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,OTHER,,,,,,,2022,0.0
NCT04220411,,2020-01-03,2023-04-11,,2023-12-08,2020-01-05,2020-01-07,ACTUAL,2023-12-08,2023-12-11,ACTUAL,,,,2023-12-08,2023-12-11,ACTUAL,2020-12-08,ACTUAL,2020-12-08,2023-12,2023-12-31,2022-06-13,ACTUAL,2022-06-13,2021-12-29,ACTUAL,2021-12-29,,INTERVENTIONAL,,"Final Visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. One subject in Phase II was early terminated at Visit 5.",A Study for AR100DP1 in Mild to Moderate Atopic Dermatitis (AD),"A Phase I/IIa Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of AR100DP1 in Healthy Subjects, and Subjects With Mild to Moderate Atopic Dermatitis",TERMINATED,,PHASE1/PHASE2,17.0,ACTUAL,Arjil Pharmaceuticals LLC,,4.0,,"Due to the two AEs in Phase IIa study, recruiting was stopped for safety sake. The study was currently terminated.",,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,INDUSTRY,,,,,,,2022,0.0
NCT03353753,,2017-11-20,2021-02-19,,2022-11-17,2017-11-21,2017-11-27,ACTUAL,2021-03-24,2021-04-23,ACTUAL,,,,2022-11-17,2022-11-21,ACTUAL,2018-02-27,ACTUAL,2018-02-27,2022-11,2022-11-30,2022-05-11,ACTUAL,2022-05-11,2019-05-31,ACTUAL,2019-05-31,,INTERVENTIONAL,INVICTUS,"The baseline analysis population was the intent-to-treat (ITT) population, defined as those who signed the ICF and were randomized",Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies,"A Phase 3, INterVentional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients With AdvanCed Gastrointestinal Stromal TUmorS Who Have Received Treatment With Prior Anticancer Therapies",COMPLETED,,PHASE3,129.0,ACTUAL,"Deciphera Pharmaceuticals, LLC",,2.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,INDUSTRY,,,,,,,2022,1.0
NCT04342182,,2020-03-31,,,2022-03-22,2020-04-09,2020-04-10,ACTUAL,,,,,,,2022-03-22,2022-04-01,ACTUAL,2020-04-08,ACTUAL,2020-04-08,2022-03,2022-03-31,2020-09-30,ACTUAL,2020-09-30,2020-07-01,ACTUAL,2020-07-01,,INTERVENTIONAL,ConCoVid-19,,Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease (CONCOVID Study),Convalescent Plasma Therapy From Recovered Covid-19 Patients as Therapy for Hospitalized Patients With Covid-19,TERMINATED,,PHASE2/PHASE3,86.0,ACTUAL,Erasmus Medical Center,,2.0,,new insights into COVID19 pathogenesis,f,,,,t,f,f,,,,,,,,,,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,OTHER,,,,,,,2020,0.0
NCT04697693,,2021-01-04,2022-03-01,,2022-04-12,2021-01-05,2021-01-06,ACTUAL,2022-03-01,2022-03-28,ACTUAL,,,,2022-04-12,2022-05-11,ACTUAL,2021-03-03,ACTUAL,2021-03-03,2022-04,2022-04-30,2021-05-20,ACTUAL,2021-05-20,2021-05-20,ACTUAL,2021-05-20,,INTERVENTIONAL,,,Antidepressant Response in Older Adults With Comorbid PTSD and MDD,Antidepressant Response in Older Adults With Comorbid PTSD and MDD,TERMINATED,,PHASE4,1.0,ACTUAL,New York State Psychiatric Institute,The study had a planned accrual of 25 participants but only accrued 1 participant due to challenges in recruiting during the pandemic.,1.0,,Unable to recruit participants in a timely fashion due to COVID pandemic,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,OTHER,,,,,,,2021,0.0
NCT03172897,,2017-04-17,,,2022-04-19,2017-05-31,2017-06-01,ACTUAL,,,,,,,2022-04-19,2022-04-26,ACTUAL,2017-08-20,ACTUAL,2017-08-20,2022-04,2022-04-30,2022-11,ESTIMATED,2022-11-30,2017-08-21,ACTUAL,2017-08-21,,INTERVENTIONAL,,,Low-dose Dexmedetomidine in Mechanically Ventilated ICU Patients,"Low-dose Dexmedetomidine for Delirium Prevention in Mechanically Ventilated Patients in Intensive Care Unit: a Multicenter, Randomised, Double-blinded, Placebo-controlled Trial",SUSPENDED,,PHASE4,260.0,ESTIMATED,Peking University First Hospital,,2.0,,The trial was stopped because of difficulty in recruiting patients (another trial had similar inclusion/exclusion criteria). No patients was recruited in this trial.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,OTHER,,,,,,,2022,0.0
NCT03847389,,2019-01-23,2021-05-05,,2021-06-01,2019-02-18,2019-02-20,ACTUAL,2021-06-01,2021-06-23,ACTUAL,,,,2021-06-01,2021-06-23,ACTUAL,2019-09-09,ACTUAL,2019-09-09,2021-01,2021-01-31,2020-07-28,ACTUAL,2020-07-28,2020-05-02,ACTUAL,2020-05-02,,INTERVENTIONAL,,Study was terminated prior to enrolling participants in cohort 2 or cohort 3.,Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis,Open-Label Study of the Pharmacokinetics and Safety Including HPA Axis Suppression Potential of Clobetasol Topical Oil in Pediatric Subjects With Moderate to Severe Atopic Dermatitis,TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,"Hill Dermaceuticals, Inc.","The study was terminated early due to the COVID pandemic with very low subject enrollment. Due to the small number of subjects that completed when the study was prematurely terminated, pharmacokinetic, exploratory, sensitivity, as well as some safety analyses was not completed under the SAP.",1.0,,Difficulty in enrollment and COVID-19 pandemic.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,INDUSTRY,,,,,,,2020,0.0
NCT03466021,,2018-03-02,,,2021-03-12,2018-03-08,2018-03-15,ACTUAL,,,,,,,2021-03-12,2021-03-16,ACTUAL,2018-01-01,ACTUAL,2018-01-01,2021-03,2021-03-31,2020-05-31,ACTUAL,2020-05-31,2020-05-31,ACTUAL,2020-05-31,,INTERVENTIONAL,,,Effects of Liraglutide in Chronic Obstructive Pulmonary Disease,Effects of GLP-1 Receptor Agonist Treatment on Pulmonary Function and Quality of Life in Obese Patients With Chronic Obstructive Pulmonary Disease.,COMPLETED,,PHASE4,40.0,ACTUAL,Esbjerg Hospital - University Hospital of Southern Denmark,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,OTHER,,,,,,,2020,0.0
NCT03061110,,2017-02-17,,,2018-04-26,2017-02-21,2017-02-23,ACTUAL,,,,,,,2018-04-26,2018-04-30,ACTUAL,2018-11-01,ESTIMATED,2018-11-01,2018-04,2018-04-30,2020-12-31,ESTIMATED,2020-12-31,2020-12-28,ESTIMATED,2020-12-28,,INTERVENTIONAL,,,Stromal Vascular Fraction for Treatment of Xerostomia,Evaluation of the Use of the Tissue Genesis® Icellator Cell Isolation System® (Icellator) Autologous Adipose Stromal Vascular Fraction Cells as a Treatment for Post-Irradiated Induced Xerostomia in Head and Neck Cancer Patients,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Midwestern Regional Medical Center,,2.0,,Internal funding not awarded.,f,,,,f,t,f,,,f,,,,,,UNDECIDED,,2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,OTHER,,,,,,,2020,0.0
NCT03604289,,2018-07-19,,,2024-06-07,2018-07-19,2018-07-27,ACTUAL,,,,,,,2024-06-07,2024-06-10,ACTUAL,2019-04-01,ACTUAL,2019-04-01,2024-06,2024-06-30,2023-06-03,ACTUAL,2023-06-03,2023-05-03,ACTUAL,2023-05-03,,INTERVENTIONAL,,,Angiotensin 1-7 in Obesity Hypertension,Cardiovascular Effects of Angiotensin 1-7 in Obesity Hypertension,TERMINATED,,EARLY_PHASE1,8.0,ACTUAL,Milton S. Hershey Medical Center,,2.0,,Funding terminated,f,,,,,t,f,,,,,,,,,,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,OTHER,,,,,,,2023,0.0
NCT05160402,,2021-11-24,,,2022-10-12,2021-12-15,2021-12-16,ACTUAL,,,,,,,2022-10-12,2022-10-14,ACTUAL,2021-12-07,ACTUAL,2021-12-07,2022-10,2022-10-31,2022-08-18,ACTUAL,2022-08-18,2022-06-15,ACTUAL,2022-06-15,,INTERVENTIONAL,,,Evaluation of IGM-6268 in Healthy Volunteers,"A Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Intranasal Plus Intraoral IGM-6268 in Healthy Volunteers",TERMINATED,,PHASE1,54.0,ACTUAL,"IGM Biosciences, Inc.",,6.0,,Sponsor decision,,,,,t,t,f,,,,,,,,,,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,INDUSTRY,,,,,,,2022,0.0
NCT05094934,,2021-09-27,,,2023-12-22,2021-10-15,2021-10-26,ACTUAL,,,,,,,2023-12-22,2023-12-26,ACTUAL,2021-11-09,ACTUAL,2021-11-09,2023-12,2023-12-31,2022-08-24,ACTUAL,2022-08-24,2022-07-15,ACTUAL,2022-07-15,,INTERVENTIONAL,,,A Research Study Looking Into Levels of the Medicine NNC0385-0434 in the Body and How Well it is Tolerated in Participants With Impaired Kidney Function Compared to Participants With Normal Kidney Function,"Investigation of Pharmacokinetics, Safety and Tolerability of Oral NNC0385-0434 in Participants With Various Degrees of Impaired Renal Function and in Participants With Normal Renal Function",TERMINATED,,PHASE1,60.0,ACTUAL,Novo Nordisk A/S,,4.0,,Business decision,f,,,,f,f,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,INDUSTRY,,,,,,,2022,0.0
NCT04057937,,2019-08-13,2021-12-09,,2024-07-08,2019-08-13,2019-08-15,ACTUAL,2021-12-09,2022-01-06,ACTUAL,,,,2024-07-08,2024-07-17,ACTUAL,2019-10-16,ACTUAL,2019-10-16,2024-07,2024-07-31,2021-06-07,ACTUAL,2021-06-07,2021-01-18,ACTUAL,2021-01-18,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis,"A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Palmoplantar Pustulosis in Japan",COMPLETED,,PHASE2,90.0,ACTUAL,Amgen,,2.0,,,f,,,,f,t,f,,,t,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,INDUSTRY,,,,,,,2021,1.0
NCT03998423,,2018-08-23,,,2020-07-22,2019-06-24,2019-06-26,ACTUAL,,,,,,,2020-07-22,2020-07-24,ACTUAL,2019-11-14,ACTUAL,2019-11-14,2020-07,2020-07-31,2020-07-14,ACTUAL,2020-07-14,2020-07-14,ACTUAL,2020-07-14,,INTERVENTIONAL,AMBITION,,Oral Fecal Microbiota Transplant Feasibility Study in Alzheimer's Disease,Oral Fecal Microbiota Transplant Feasibility Study in Alzheimer's Disease,TERMINATED,,PHASE1,5.0,ACTUAL,"University of Wisconsin, Madison",,3.0,,"SARS-CoV-2 has been detected in fecal material. Although FMT is screened for SARS-CoV-2, the team decided to end the study to minimize risk to participants.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,OTHER,,,,,,,2020,0.0
NCT03991884,,2019-06-17,,,2023-07-03,2019-06-17,2019-06-19,ACTUAL,,,,,,,2023-07-03,2023-07-06,ACTUAL,2019-09-24,ACTUAL,2019-09-24,2023-06,2023-06-30,2023-06-28,ACTUAL,2023-06-28,2022-10-20,ACTUAL,2022-10-20,,INTERVENTIONAL,,,Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia,"A Phase I Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Escalating Doses of Inotuzumab Ozogamicin (DA-EPOCH-InO) in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia",COMPLETED,,PHASE1,24.0,ACTUAL,University of Washington,,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,OTHER,,,,,,,2023,1.0
NCT03635437,,2018-08-09,,,2022-11-01,2018-08-14,2018-08-17,ACTUAL,,,,,,,2022-11-01,2022-11-02,ACTUAL,2018-09-05,ACTUAL,2018-09-05,2022-11,2022-11-30,2022-09-27,ACTUAL,2022-09-27,2022-09-27,ACTUAL,2022-09-27,,INTERVENTIONAL,,,Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes,"A Phase I/II, 3-Arm, Open Label, Single Centre Study to Investigate the Safety and Effect of Oral GABA Therapy on Beta-Cell Regeneration in Type 1-diabetes Patients",COMPLETED,,PHASE1/PHASE2,35.0,ACTUAL,Uppsala University Hospital,,3.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,OTHER,,,,,,,2022,1.0
NCT04511026,,2020-08-07,2023-08-15,,2023-09-18,2020-08-10,2020-08-12,ACTUAL,2023-09-18,2023-10-11,ACTUAL,,,,2023-09-18,2023-10-11,ACTUAL,2021-01-20,ACTUAL,2021-01-20,2023-09,2023-09-30,2021-06-10,ACTUAL,2021-06-10,2021-06-10,ACTUAL,2021-06-10,,INTERVENTIONAL,,,Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer,Concurrent Use of Lymphoseek and Indocyanine Green for Sentinel Lymph Node Detection in Endometrial Cancer - a Prospective Study,TERMINATED,,PHASE2,6.0,ACTUAL,Stanford University,This study did not meet its planned enrollment and did not achieve statistical power.,1.0,,Efficacy,f,,,,t,t,t,,,f,,,,,,NO,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,OTHER,,,,,,,2021,0.0
NCT03738397,,2018-11-09,2022-01-10,2021-07-01,2024-02-15,2018-11-09,2018-11-13,ACTUAL,2022-01-10,2022-02-02,ACTUAL,2021-07-01,2021-07-06,ACTUAL,2024-02-15,2024-03-15,ACTUAL,2019-02-21,ACTUAL,2019-02-21,2024-02,2024-02-29,2020-12-09,ACTUAL,2020-12-09,2020-08-27,ACTUAL,2020-08-27,,INTERVENTIONAL,Heads Up,The intent-to-treat (ITT) population includes all randomized participants according to the treatment groups that they were randomized to.,A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis,"A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis",COMPLETED,,PHASE3,673.0,ACTUAL,AbbVie,,2.0,,,t,,,,t,t,f,,,t,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,INDUSTRY,,NCT04159597,NO_LONGER_AVAILABLE,,,,2020,1.0
NCT04274166,,2020-02-12,,,2021-05-25,2020-02-17,2020-02-18,ACTUAL,,,,,,,2021-05-25,2021-05-28,ACTUAL,2021-05,ESTIMATED,2021-05-31,2021-05,2021-05-31,2022-04,ESTIMATED,2022-04-30,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum,The Efficacy and Safety of Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum,WITHDRAWN,,PHASE2,0.0,ACTUAL,Wake Forest University Health Sciences,,1.0,,"Contracting never completed, closed the IRB",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,OTHER,,,,,,,2022,0.0
NCT02419664,,2015-01-19,,,2022-03-15,2015-04-14,2015-04-17,ESTIMATED,,,,,,,2022-03-15,2022-03-31,ACTUAL,2015-01,ACTUAL,2015-01-31,2022-03,2022-03-31,2022-01-13,ACTUAL,2022-01-13,2022-01-13,ACTUAL,2022-01-13,,INTERVENTIONAL,,,Ga-68-DOTATOC -PET in the Management of Pituitary Tumours,Ga-68-DOTATOC -PET in the Management of Pituitary Tumours,TERMINATED,,PHASE3,22.0,ACTUAL,Göteborg University,,1.0,,The hypothesis we had that we could predict the growth rate from PET uptake could not be confirmer and 3-year follow up was no longer considered motivated,,,,,f,t,f,,,,,,,,,,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,OTHER,,,,,,,2022,0.0
NCT01554618,,2012-03-13,2020-11-08,,2021-11-02,2012-03-13,2012-03-15,ESTIMATED,2020-11-08,2020-12-03,ACTUAL,,,,2021-11-02,2021-11-30,ACTUAL,2011-12-02,ACTUAL,2011-12-02,2021-10,2021-10-31,2021-05-05,ACTUAL,2021-05-05,2020-05-06,ACTUAL,2020-05-06,,INTERVENTIONAL,,Baseline analysis performed on Intent-to-Treat (ITT) Analysis Set which consisted of all randomized patients who received at least 1 dose of randomized study medication.,Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes,"A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Assess the Safety and Efficacy of Exenatide Once Weekly in Adolescents With Type 2 Diabetes",COMPLETED,,PHASE3,84.0,ACTUAL,AstraZeneca,"For statistical analyses of change from baseline in HOMA-B and HOMA-S, due to the limited sample size (n=14 and n=7 in the extenatide and placebo groups, respectively) it is difficult to accurately interpret these data. The study design included an extended safety follow-up period which continued for up to 3 years or until the increase in height between two 6-month interval visits was \<5 mm (whichever came first). No study medication was administered during the extended safety follow-up period.",2.0,,,f,,,,t,,,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,INDUSTRY,,,,,,,2021,1.0
NCT04209179,,2019-11-28,,,2021-06-09,2019-12-19,2019-12-24,ACTUAL,,,,,,,2021-06-09,2021-06-11,ACTUAL,2020-07-23,ACTUAL,2020-07-23,2021-06,2021-06-30,2021-05-25,ACTUAL,2021-05-25,2020-12-28,ACTUAL,2020-12-28,,INTERVENTIONAL,,,"A Clinical Study Investigating the Safety, Tolerability, PK and PD of PCO371 in Patients With Hypoparathyroidism","A Randomized, Double-Blind, Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PCO371 in Patients With Hypoparathyroidism",TERMINATED,,PHASE1,5.0,ACTUAL,Chugai Pharmaceutical,,4.0,,"Terminated on the basis of the currently uncertain risk-benefit balance for the patients, and the strategic position of the development program",f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).",2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,INDUSTRY,,,,,,,2021,0.0
NCT02282917,,2014-10-31,2021-10-26,,2022-02-22,2014-11-04,2014-11-05,ESTIMATED,2022-02-22,2022-05-11,ACTUAL,,,,2022-02-22,2022-05-11,ACTUAL,2015-12,ACTUAL,2015-12-31,2021-12,2021-12-31,2021-01-04,ACTUAL,2021-01-04,2017-05-30,ACTUAL,2017-05-30,,INTERVENTIONAL,,"Two participants were withdrawn from the study prior to the administration of the study drug: one was deemed ineligible, and one chose not to participate.",Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma,Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma,TERMINATED,,EARLY_PHASE1,7.0,ACTUAL,Massachusetts Eye and Ear Infirmary,"The supplier of AR-42 was unable to continue to supply drugs after 2017. We elected to present the data on five of the originally planned 20 patients. Accrual was also limited by patient willingness to accept potential additional peri-operative risk without a reasonable likelihood of benefit from only 3 weeks of therapy with AR-42. Other limitations include possible selection bias, lack of control subjects, and the inability to perform meaningful statistical analysis.",1.0,,Drug manufacturing logistics; lack of access to drug supply,f,,,,t,,,,,,,,,,,NO,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,OTHER,,,,,,,2021,0.0
NCT03490942,,2018-03-25,2020-11-04,,2021-02-02,2018-04-01,2018-04-06,ACTUAL,2021-02-02,2021-02-21,ACTUAL,,,,2021-02-02,2021-02-21,ACTUAL,2018-03-15,ACTUAL,2018-03-15,2020-05,2020-05-31,2020-02-10,ACTUAL,2020-02-10,2019-11-04,ACTUAL,2019-11-04,,INTERVENTIONAL,,,Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses,Fixed Rate Continuous Subcutaneous Glucagon Infusion (CSGI) vs Placebo in Type 1 Diabetes Mellitus Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses to Insulin-Induced Hypoglycemia,TERMINATED,,PHASE2,49.0,ACTUAL,Xeris Pharmaceuticals,,4.0,,Primary endpoint was not met,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,INDUSTRY,,,,,,,2020,0.0
NCT04834973,,2021-03-29,,,2023-04-13,2021-04-05,2021-04-08,ACTUAL,,,,,,,2023-04-13,2023-04-18,ACTUAL,2021-05-07,ACTUAL,2021-05-07,2023-04,2023-04-30,2022-07-12,ACTUAL,2022-07-12,2022-07-12,ACTUAL,2022-07-12,,INTERVENTIONAL,,,A Trial of Tigilanol Tiglate in Combination With Pembrolizumab in Stage IIIB to IV M1c-melanoma,"A Phase Ib/IIa, Dose-escalation Study to Evaluate the Safety, Tolerability, and Preliminary Effectiveness of Intratumoural Tigilanol Tiglate in Combination With Intravenous Pembrolizumab in Adults With Stage IIIb to IV M1c-melanoma",TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,QBiotics Group Limited,,1.0,,Insufficient Patient Recruitment Rates,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,INDUSTRY,,,,,,,2022,0.0
NCT03649321,,2018-08-16,2023-07-19,,2023-10-19,2018-08-24,2018-08-28,ACTUAL,2023-10-19,2023-11-09,ACTUAL,,,,2023-10-19,2023-11-09,ACTUAL,2019-01-03,ACTUAL,2019-01-03,2023-10,2023-10-31,2022-06-27,ACTUAL,2022-06-27,2022-06-27,ACTUAL,2022-06-27,,INTERVENTIONAL,,The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.,Clinical Trial of Chemotherapy and Bemcentinib for Metastatic Pancreatic Cancer,A phase1b/2 Clinical Trial of Chemotherapy and the AXL-inhibitor Bemcentinib for Patients With Metastatic Pancreatic Cancer,TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,Funding was terminated early because research interests were going in a different direction.,,,,,t,t,f,,,,,,,,,,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,OTHER,,,,,,,2022,0.0
NCT05065164,,2021-09-22,,,2023-03-11,2021-09-22,2021-10-01,ACTUAL,,,,,,,2023-03-11,2023-03-14,ACTUAL,2021-09-14,ACTUAL,2021-09-14,2023-02,2023-02-28,2023-09-25,ESTIMATED,2023-09-25,2023-03-20,ESTIMATED,2023-03-20,,INTERVENTIONAL,,,Denosumab and Screw Fixation for Osteoporotic Compression Fracture,Attending Doctor of Shenzhen People's Hospital,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Shenzhen People's Hospital,,2.0,,no partcipants enrolled,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,OTHER,,,,,,,2023,0.0
NCT03846258,,2019-02-14,,,2021-04-26,2019-02-15,2019-02-19,ACTUAL,,,,,,,2021-04-26,2021-04-28,ACTUAL,2019-05-01,ACTUAL,2019-05-01,2021-04,2021-04-30,2024-04-01,ESTIMATED,2024-04-01,2024-04-01,ESTIMATED,2024-04-01,,INTERVENTIONAL,,,High Versus Low Bicarbonate Bath in Critically-ill Patients Receiving Continuous Renal Replacement Therapy,High Versus Low Bicarbonate Bath in Critically-ill Patients Receiving Continuous Renal Replacement Therapy: a Pragmatic Randomized Control Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,Mayo Clinic,,2.0,,Due to the fact that we were unable to find subjects who met all inclusion and exclusion criteria it was determined to withdraw this study.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,OTHER,,,,,,,2024,0.0
NCT02603432,,2015-11-09,2020-10-16,,2024-02-29,2015-11-10,2015-11-11,ESTIMATED,2020-11-23,2020-12-17,ACTUAL,,,,2024-02-29,2024-03-27,ACTUAL,2016-04-25,ACTUAL,2016-04-25,2024-02,2024-02-29,2023-03-28,ACTUAL,2023-03-28,2019-10-21,ACTUAL,2019-10-21,,INTERVENTIONAL,,The full analysis set included all randomized participants.,A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100),"A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE AS A MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER WHOSE DISEASE DID NOT PROGRESS AFTER COMPLETION OF FIRST-LINE PLATINUM-CONTAINING CHEMOTHERAPY",COMPLETED,,PHASE3,700.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,INDUSTRY,,,,,,,2023,1.0
NCT03925727,,2019-04-19,2023-02-09,,2023-04-04,2019-04-19,2019-04-24,ACTUAL,2023-02-09,2023-03-09,ACTUAL,,,,2023-04-04,2023-04-05,ACTUAL,2019-03-28,ACTUAL,2019-03-28,2023-03,2023-03-31,2020-06-11,ACTUAL,2020-06-11,2020-06-11,ACTUAL,2020-06-11,,INTERVENTIONAL,,Intent-to-treat (ITT) set included all randomized participants,Tavilermide Ophthalmic Solution for the Treatment of Dry Eye,"Multi-Center, Randomized,Double-Masked, Vehicle-Controlled Study to Assess the Safety and Efficacy Study of Tavilermide Ophthalmic Solutions for the Treatment of Dry Eye",COMPLETED,,PHASE3,623.0,ACTUAL,"Mimetogen Pharmaceuticals USA, Inc.",,3.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,INDUSTRY,,,,,,,2020,1.0
NCT04336332,,2020-03-31,2022-10-14,,2023-02-06,2020-04-02,2020-04-07,ACTUAL,2023-02-06,2023-02-28,ACTUAL,,,,2023-02-06,2023-02-28,ACTUAL,2020-04-01,ACTUAL,2020-04-01,2023-02,2023-02-28,2020-10-14,ACTUAL,2020-10-14,2020-10-14,ACTUAL,2020-10-14,,INTERVENTIONAL,,,Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19,Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19,TERMINATED,,PHASE2,75.0,ACTUAL,"Rutgers, The State University of New Jersey",,3.0,,Ineffectiveness of treatment,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,OTHER,,,,,,,2020,0.0
NCT04565392,,2020-09-21,,,2021-12-04,2020-09-21,2020-09-25,ACTUAL,,,,,,,2021-12-04,2021-12-20,ACTUAL,2021-05-01,ESTIMATED,2021-05-01,2021-12,2021-12-31,2022-01-31,ESTIMATED,2022-01-31,2021-11-01,ESTIMATED,2021-11-01,,INTERVENTIONAL,Pepcid4COV19,,Remotely-conducted Trial of Famotidine vs Placebo for Patients at Home With Coronavirus (COVID) of 2019 (COVID-19),Proof-of-concept Randomized Placebo-controlled Trial of Famotidine for Outpatients With COVID-19,WITHDRAWN,,PHASE4,0.0,ACTUAL,drpykessupplements.com,,2.0,,lack of funding,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,INDUSTRY,,,,,,,2022,0.0
NCT04175834,,2019-11-22,2023-08-02,,2024-02-28,2019-11-22,2019-11-25,ACTUAL,2024-02-28,2024-03-04,ACTUAL,,,,2024-02-28,2024-03-04,ACTUAL,2020-02-05,ACTUAL,2020-02-05,2024-02,2024-02-29,2022-05-13,ACTUAL,2022-05-13,2022-05-13,ACTUAL,2022-05-13,,INTERVENTIONAL,PRECEPT,,Comparing Risk and Severity of IRRs in Patients Premedicated With Cetirizine vs. Diphenhydramine Prior to Ocrelizumab,Comparing the Risk and Severity of Infusion-Related Reactions in Patients Premedicated With Cetirizine Versus Diphenhydramine Prior to Ocrelizumab Infusions,COMPLETED,,PHASE3,19.0,ACTUAL,Providence Health & Services,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,OTHER,,,,,,,2022,1.0
NCT02842125,,2016-07-01,,,2020-05-30,2016-07-19,2016-07-22,ESTIMATED,,,,,,,2020-05-30,2020-06-02,ACTUAL,2018-11-20,ACTUAL,2018-11-20,2020-05,2020-05-31,2020-05-08,ACTUAL,2020-05-08,2020-05-08,ACTUAL,2020-05-08,,INTERVENTIONAL,,,Safety and Efficacy of Intra-Arterial and Intra-Tumoral Ad-p53 With Capecitabine (Xeloda) or Anti-PD-1 in Liver Metastases of Solid Tumors and Recurrent Head and Neck Squamous Cell Cancer,"Phase 1/2 Evaluation of Adenoviral p53 (Ad-p53) in Combination With Capecitabine (Xeloda) or Anti-PD-1 in Patients With Unresectable Liver Metastases of Colorectal Carcinoma(CRC) and Other Solid Tumors, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) and Primary Hepatic Cancers With Known Disease Progression on Standard Therapy",TERMINATED,,PHASE1/PHASE2,4.0,ACTUAL,"MultiVir, Inc.",,3.0,,Arm C rolled into parallel study; Arms A and B halted for greater efficacy in Arm C,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,INDUSTRY,,,,,,,2020,0.0
NCT02472938,,2015-05-11,,,2015-12-23,2015-06-12,2015-06-16,ESTIMATED,,,,,,,2015-12-23,2015-12-28,ESTIMATED,2015-07,,2015-07-31,2015-12,2015-12-31,2020-07,ESTIMATED,2020-07-31,2019-07,ESTIMATED,2019-07-31,,INTERVENTIONAL,PROMPT,,Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis,"Phase IV, Interventional, multicenteR, Double-blind, Randomized, Placebo-controlled Study tO Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With relapsingremitTing Multiple Sclerosis",WITHDRAWN,,PHASE4,0.0,ACTUAL,Biogen,,2.0,,Sponsor Decision,f,,,,f,,,,,,,,,,,,,2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,INDUSTRY,,,,,,,2020,0.0
NCT03802058,,2019-01-06,,,2023-04-27,2019-01-09,2019-01-14,ACTUAL,,,,,,,2023-04-27,2023-04-28,ACTUAL,2019-03-20,ACTUAL,2019-03-20,2023-04,2023-04-30,2021-12-12,ACTUAL,2021-12-12,2021-12-12,ACTUAL,2021-12-12,,INTERVENTIONAL,,,Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer,Concurrent Nab--paclitaxel/Carboplatin and Thoracic Radiotherapy in Inoperable Stage III Squamous Cell Lung Cancer,TERMINATED,,PHASE2,24.0,ACTUAL,Wuhan University,,1.0,,The study was halted because enrollment was too slow,f,,,,,f,f,,,,,,2 years after the end of the study,Researchers who participate in this study,,YES,all IPD can be shared by all researchers who participate in this study by e-mail contact,2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,OTHER,,,,,,,2021,0.0
NCT04717362,,2020-12-07,,,2024-04-22,2021-01-15,2021-01-22,ACTUAL,,,,,,,2024-04-22,2024-04-24,ACTUAL,2024-03-01,ESTIMATED,2024-03-01,2024-04,2024-04-30,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,The Effects of Natesto For Treatment Of Hypogonadism,The Effects of Natesto For Treatment Of Hypogonadism On Maintenance Of Spermatogensis.,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Baylor College of Medicine,,1.0,,No longer wanting to enroll or start study.,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,OTHER,,,,,,,2024,0.0
NCT04770246,,2021-02-16,,,2024-08-30,2021-02-22,2021-02-25,ACTUAL,,,,,,,2024-08-30,2024-09-04,ACTUAL,2021-03-31,ACTUAL,2021-03-31,2024-08,2024-08-31,2023-03-06,ACTUAL,2023-03-06,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,,,TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Mutations,A Phase 2 Study of TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Inactivating Mutations,TERMINATED,,PHASE1,17.0,ACTUAL,"Taiho Oncology, Inc.",,4.0,,The Sponsor had decided to terminate this clinical trial due to an insufficient rate of accrual of patients.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,INDUSTRY,,,,,,,2023,0.0
NCT03745651,,2018-11-15,2021-10-20,2020-11-17,2023-09-21,2018-11-15,2018-11-19,ACTUAL,2021-11-19,2021-12-17,ACTUAL,2020-11-17,2020-11-19,ACTUAL,2023-09-21,2023-09-28,ACTUAL,2018-12-20,ACTUAL,2018-12-20,2023-09,2023-09-30,2020-11-09,ACTUAL,2020-11-09,2019-11-18,ACTUAL,2019-11-18,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all participants who were randomized to the study.,TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis,"Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 2 (TRuE AD2) - A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults With Atopic Dermatitis",COMPLETED,,PHASE3,618.0,ACTUAL,Incyte Corporation,,7.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,INDUSTRY,,,,,,,2020,1.0
NCT04593641,,2020-10-05,2021-12-23,,2022-04-06,2020-10-18,2020-10-20,ACTUAL,2022-04-06,2022-04-08,ACTUAL,,,,2022-04-06,2022-04-08,ACTUAL,2020-09-04,ACTUAL,2020-09-04,2022-04,2022-04-30,2021-04-05,ACTUAL,2021-04-05,2020-10-26,ACTUAL,2020-10-26,,INTERVENTIONAL,,,"This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)","A Pilot Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Virology of CT-P59 in Patient With Mild Symptoms of SARS-CoV-2 Infection",COMPLETED,,PHASE1,18.0,ACTUAL,Celltrion,,3.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,INDUSTRY,,,,,,,2021,1.0
NCT03377179,,2017-12-01,,2023-03-30,2023-03-30,2017-12-13,2017-12-19,ACTUAL,,,,,2023-04-04,ACTUAL,2023-03-30,2023-04-04,ACTUAL,2018-03-07,ACTUAL,2018-03-07,2023-03,2023-03-31,2022-06-21,ACTUAL,2022-06-21,2022-06-21,ACTUAL,2022-06-21,,INTERVENTIONAL,,,A Study of ABC294640 (Yeliva ®) Alone and in Combination With Hydroxychloroquine Sulfate in Treatment of Patients With Advanced Cholangiocarcinoma,"A Phase I/IIA Study of ABC294640 Alone and in Combination With Hydroxychloroquine Sulfate in the Treatment of Patients With Advanced, Unresectable Intra-hepatic, Perihilar and Extra-Hepatic Cholangiocarcinoma",COMPLETED,,PHASE2,65.0,ACTUAL,RedHill Biopharma Limited,,1.0,,,t,,,,f,t,f,,,,,,,,,NO,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,INDUSTRY,,NCT03414489,AVAILABLE,,,,2022,1.0
NCT04355728,,2020-04-13,2021-10-15,,2021-12-01,2020-04-17,2020-04-21,ACTUAL,2021-12-01,2021-12-06,ACTUAL,,,,2021-12-01,2021-12-06,ACTUAL,2020-04-25,ACTUAL,2020-04-25,2021-12,2021-12-31,2020-10-31,ACTUAL,2020-10-31,2020-10-31,ACTUAL,2020-10-31,,INTERVENTIONAL,,,Use of UC-MSCs for COVID-19 Patients,Umbilical Cord-derived Mesenchymal Stem Cells for COVID-19 Patients With Acute Respiratory Distress Syndrome (ARDS),COMPLETED,,PHASE1/PHASE2,24.0,ACTUAL,University of Miami,"The inferences we make from the efficacy results observed in this phase 1/2a trial in 24 subjects, including the outcome of survival, are still subject to limitations of sample size and potential bias because of factors we were not yet aware of.",2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,OTHER,,,,,,,2020,1.0
NCT05177770,,2021-12-05,2024-02-22,,2024-05-09,2022-01-03,2022-01-05,ACTUAL,2024-05-09,2024-05-17,ACTUAL,,,,2024-05-09,2024-05-17,ACTUAL,2022-01-17,ACTUAL,2022-01-17,2024-05,2024-05-31,2023-04-05,ACTUAL,2023-04-05,2023-04-05,ACTUAL,2023-04-05,,INTERVENTIONAL,,The Safety Analysis Set included all participants who received any amount of study drug,Study of SRF617 With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer,A Phase 2 Trial of SRF617 in Combination With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration-Resistant Prostate Cancer,TERMINATED,,PHASE2,16.0,ACTUAL,"Coherus Biosciences, Inc.","This study was originally intended to be conducted in 2 stages (1 and 2); however, a strategic decision was made to terminate the study during Stage 1.",1.0,,"The study was terminated for strategic reasons, not due to any safety concerns.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,INDUSTRY,,,,,,,2023,0.0
NCT04962503,,2021-06-23,2023-02-03,,2023-03-16,2021-07-10,2021-07-15,ACTUAL,2023-03-16,2023-04-11,ACTUAL,,,,2023-03-16,2023-04-11,ACTUAL,2021-06-03,ACTUAL,2021-06-03,2023-03,2023-03-31,2022-02-04,ACTUAL,2022-02-04,2022-02-04,ACTUAL,2022-02-04,,INTERVENTIONAL,,,A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS),"A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS) Due to Distal [M2 Segment and Beyond] Arterial Large Vessel Occlusion (LVO) or Perforator Occlusion and Who Are Ineligible for Intravenous Thrombolysis (IVT) or Endovascular Thrombectomy (EVT)",COMPLETED,,PHASE2,6.0,ACTUAL,Clinuvel Pharmaceuticals Limited,,1.0,,,f,,,,,t,f,,,t,,,,,,,,2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,INDUSTRY,,,,,,,2022,1.0
NCT05312021,,2022-03-08,,,2023-03-06,2022-03-28,2022-04-05,ACTUAL,,,,,,,2023-03-06,2023-03-08,ACTUAL,2022-04,ESTIMATED,2022-04-30,2023-03,2023-03-31,2023-11,ESTIMATED,2023-11-30,2023-09,ESTIMATED,2023-09-30,,INTERVENTIONAL,SP9In-HFpEF,,Selective PDE9 Inhibition With IMR-687 in Adults With Heart Failure With Preserved Ejection Fraction,Selective PDE9 Inhibition With IMR-687 in Adults With Heart Failure With Preserved Ejection Fraction: a Safety and Efficacy Phase 2 Randomized Clinical Study (SP9In-HFpEF),WITHDRAWN,,PHASE2,0.0,ACTUAL,"Imara, Inc.",,2.0,,Study Termination,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:01:20.651919,2024-10-15 22:01:20.651919,INDUSTRY,,,,,,,2023,0.0
NCT03425461,,2018-01-11,,,2021-04-01,2018-02-01,2018-02-07,ACTUAL,,,,,,,2021-04-01,2021-04-02,ACTUAL,2018-06-14,ACTUAL,2018-06-14,2021-03,2021-03-31,2021-03-04,ACTUAL,2021-03-04,2021-03-04,ACTUAL,2021-03-04,,INTERVENTIONAL,,,Anti-SEMA4D Monoclonal Antibody VX15/2503 With Nivolumab or Ipilimumab in Treating Patients With Stage III or IV Melanoma,Phase I Study Combining an Anti-SEMA4D Antibody VX15/2503 With Checkpoint Inhibitors for Patients With Advanced Melanoma Who Have Progressed on Prior Anti-PD1/L1 Based Therapies,TERMINATED,,PHASE1,6.0,ACTUAL,Jonsson Comprehensive Cancer Center,,2.0,,funding,,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,OTHER,,,,,,,2021,0.0
NCT02245841,,2014-09-11,2023-10-03,,2024-06-07,2014-09-19,2014-09-22,ESTIMATED,2024-06-07,2024-06-11,ACTUAL,,,,2024-06-07,2024-06-11,ACTUAL,2015-06-15,ACTUAL,2015-06-15,2024-06,2024-06-30,2021-07-14,ACTUAL,2021-07-14,2021-07-14,ACTUAL,2021-07-14,,INTERVENTIONAL,,,Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis,Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis,COMPLETED,,PHASE4,19.0,ACTUAL,The Cleveland Clinic,,1.0,,,f,,,,f,,,,,,,,CDSAI-A scores and adverse events at each study assessment point will be included and available in the publication indefinitely.,Available to all.,https://pubmed.ncbi.nlm.nih.gov/37941470/,YES,Limited IPD will be shared within the publication.,2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,OTHER,,,,,,,2021,1.0
NCT05600036,,2022-10-12,2024-06-26,,2024-06-26,2022-10-27,2022-10-31,ACTUAL,2024-06-26,2024-07-23,ACTUAL,,,,2024-06-26,2024-07-23,ACTUAL,2022-09-27,ACTUAL,2022-09-27,2024-06,2024-06-30,2023-07-25,ACTUAL,2023-07-25,2023-06-29,ACTUAL,2023-06-29,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis,"A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis",COMPLETED,,PHASE2,228.0,ACTUAL,Alumis Inc,,6.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,INDUSTRY,,,,,,,2023,1.0
NCT05179421,,2021-12-16,2024-01-26,,2024-02-23,2021-12-16,2022-01-05,ACTUAL,2024-02-23,2024-03-19,ACTUAL,,,,2024-02-23,2024-03-19,ACTUAL,2022-05-09,ACTUAL,2022-05-09,2022-11,2022-11-30,2023-02-10,ACTUAL,2023-02-10,2023-02-10,ACTUAL,2023-02-10,,INTERVENTIONAL,,"As noted in Participant Flow, there were 14 participants in Arm 1 and 11 participants in Arm 2. One subject in Arm 1 experienced near syncope during intravenous catheter insertion. This rapidly resolved spontaneously, but the subject did not further participate and did not receive study drug or undergo baseline testing.",Dose Ranging Study of Intravenous Oxytocin for Analgesia to Heat Pain,A Dose Ranging Study for a Pharmacodynamic Model of Oxytocin for Peripheral Analgesia Effects,COMPLETED,,PHASE2,25.0,ACTUAL,Wake Forest University Health Sciences,The original study design called for equal recruitment of subjects across three age ranges: young (18-39-year-old) middle (40 - 59-year-old) and older (60 - 75-year-old) with separate randomization in each group. The protocol was subsequently amended to remove this requirement.,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:09:39.175507,2024-10-15 11:09:39.175507,OTHER,,,,,,,2023,1.0
NCT06006585,,2023-08-17,,,2024-06-06,2023-08-17,2023-08-23,ACTUAL,,,,,,,2024-06-06,2024-06-07,ACTUAL,2023-09-12,ACTUAL,2023-09-12,2024-06,2024-06-30,2024-05-24,ACTUAL,2024-05-24,2024-05-24,ACTUAL,2024-05-24,,INTERVENTIONAL,,,A Study to Test How Well Different Doses of BI 771716 Are Tolerated by People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy,"Safety, Tolerability, and Pharmacokinetics of Intravitreal Single Rising Doses and Multiple Doses of BI 771716 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration (Open Label, Non-randomized)",COMPLETED,,PHASE1,20.0,ACTUAL,Boehringer Ingelheim,,4.0,,,f,,,,t,t,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).~For more details refer to:~https://www.mystudywindow.com/msw/datatransparency",2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,INDUSTRY,,,,,,,2024,1.0
NCT03927222,,2019-04-19,2024-01-19,,2024-04-02,2019-04-22,2019-04-25,ACTUAL,2024-04-02,2024-04-08,ACTUAL,,,,2024-04-02,2024-04-08,ACTUAL,2019-09-30,ACTUAL,2019-09-30,2024-04,2024-04-30,2023-02-10,ACTUAL,2023-02-10,2023-02-10,ACTUAL,2023-02-10,,INTERVENTIONAL,I-ATTAC,,Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma,I-ATTAC: Improved Anti-Tumor Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma,TERMINATED,,PHASE2,6.0,ACTUAL,Duke University,,1.0,,Resource shortage,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,OTHER,,,,,,,2023,0.0
NCT04043806,,2019-07-31,2023-06-14,,2023-06-14,2019-07-31,2019-08-02,ACTUAL,2023-06-14,2023-07-06,ACTUAL,,,,2023-06-14,2023-07-06,ACTUAL,2019-08-09,ACTUAL,2019-08-09,2023-06,2023-06-30,2022-12-14,ACTUAL,2022-12-14,2022-12-14,ACTUAL,2022-12-14,,INTERVENTIONAL,,All participants who received at least one dose of the study drug were included in the baseline characteristics.,A Study Evaluating the Long-term Safety of VX-445 Combination Therapy,"A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis",COMPLETED,,PHASE3,458.0,ACTUAL,Vertex Pharmaceuticals Incorporated,,1.0,,,t,,,,,t,f,,,,,,,,,NO,Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent research/clinical-trial-data-sharing,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,INDUSTRY,,NCT04058210,APPROVED_FOR_MARKETING,,,,2022,0.0
NCT02975921,,2016-11-17,,,2019-01-09,2016-11-28,2016-11-29,ESTIMATED,,,,,,,2019-01-09,2019-01-11,ACTUAL,2018-07,ESTIMATED,2018-07-31,2019-01,2019-01-31,2021-06,ESTIMATED,2021-06-30,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,Betadine Pleurodesis Via Tunneled Pleural Catheters,Efficacy of Povidone-Iodine Instillation Via Tunneled Pleural Catheters in Achieving Pleurodesis: A Randomized Controlled Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,Yale University,,4.0,,The site decided not to proceed with the protocol.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,OTHER,,,,,,,2021,0.0
NCT04974970,,2021-07-16,,,2023-08-24,2021-07-22,2021-07-23,ACTUAL,,,,,,,2023-08-24,2023-08-28,ACTUAL,2019-04-01,ACTUAL,2019-04-01,2023-08,2023-08-31,2022-04-19,ACTUAL,2022-04-19,2022-04-19,ACTUAL,2022-04-19,,INTERVENTIONAL,,,Pilot Study on Immunotherapy for the Treatment of Persistant Peanut Allergy,Pilot Study on Immunotherapy for the Treatment of Persistant Peanut Allergy,TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,"University Hospital, Geneva",,1.0,,early termination due to insufficient recruitment,f,,,,t,f,f,,,,,,,,,,,2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,OTHER,,,,,,,2022,0.0
NCT04904185,,2021-05-22,,,2024-07-17,2021-05-22,2021-05-27,ACTUAL,,,,,,,2024-07-17,2024-07-19,ACTUAL,2021-08-17,ACTUAL,2021-08-17,2024-07,2024-07-31,2024-07-02,ACTUAL,2024-07-02,2024-06-07,ACTUAL,2024-06-07,,INTERVENTIONAL,,,ImmPACT Expanded Multiple Antigen Specific Endogenously Derived T Cells (MASE-T) to Patients With Metastatic Melanoma,Adoptive Transfer of ImmPACT Expanded Multiple Antigen Specific Endogenously Derived T Cells (MASE-T) in Combination With Lymphodepletion and Anti-PD-1 to Patients With Metastatic Melanoma,TERMINATED,,PHASE1,6.0,ACTUAL,Herlev Hospital,,2.0,,Lack of supply of scaffolds for T-cell expansion Evaluation of step A did not support addition of pembrolizumab in step B,f,,,,t,f,f,,,,,,,,,,,2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,OTHER,,,,,,,2024,0.0
NCT02384083,,2015-03-01,,,2022-07-26,2015-03-09,2015-03-10,ESTIMATED,,,,,,,2022-07-26,2022-07-27,ACTUAL,2015-09,ACTUAL,2015-09-30,2022-07,2022-07-31,2020-03-23,ACTUAL,2020-03-23,2018-02,ACTUAL,2018-02-28,,INTERVENTIONAL,,,Filanesib (ARRY-520) in Combination With Pomalidomide and Dexamethasone for Relapsed/Refractory (R/R) Multiple Myeloma (MM) Patients,"Phase I/II, Multicenter, Open Label, Clinical Trial of Filanesib (ARRY-520) in Combination With Pomalidomide and Dexamethasone for Relapsed/Refractory (R/R) Multiple Myeloma (MM) Patients",COMPLETED,,PHASE1/PHASE2,47.0,ACTUAL,PETHEMA Foundation,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,OTHER,,,,,,,2020,0.0
NCT04520022,,2020-08-13,,,2020-08-17,2020-08-17,2020-08-20,ACTUAL,,,,,,,2020-08-17,2020-08-20,ACTUAL,2016-10-13,ACTUAL,2016-10-13,2020-08,2020-08-31,2020-01-10,ACTUAL,2020-01-10,2020-01-10,ACTUAL,2020-01-10,,INTERVENTIONAL,,,Safety and Effectiveness Study of Allogeneic Umbilical Cord Blood-derived Mesenchymal Stem Cell in Patients With RDEB,"Single Center, Single Group Assignment, Open Label Trial to Assess Safety and Effectiveness of Intravenous Allogeneic Umbilical Cord Blood-derived Mesenchymal Stem Cell in Patients With Recessive Dystrophic Epidermolysis Bullosa",COMPLETED,,PHASE1/PHASE2,5.0,ACTUAL,Gangnam Severance Hospital,,1.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,OTHER,,,,,,,2020,1.0
NCT04021264,,2019-07-10,,,2022-05-23,2019-07-15,2019-07-16,ACTUAL,,,,,,,2022-05-23,2022-05-27,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2022-05,2022-05-31,2022-01-01,ACTUAL,2022-01-01,2022-01-01,ACTUAL,2022-01-01,,INTERVENTIONAL,,,The Impact of an Epidural Anesthetic on the Consumption of Sevoflurane in Major Abdominal Surgery,The Impact of an Epidural Anesthetic on the Consumption of Sevoflurane in Major Abdominal Surgery,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,University of Alberta,,2.0,,Inability to enroll participants.,f,,,,f,f,f,,,,,,,,,,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,OTHER,,,,,,,2022,0.0
NCT03225716,,2017-06-29,2023-09-11,,2023-11-26,2017-07-20,2017-07-21,ACTUAL,2023-11-26,2024-05-03,ACTUAL,,,,2023-11-26,2024-05-03,ACTUAL,2017-10-20,ACTUAL,2017-10-20,2023-11,2023-11-30,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom's Macroglobulinemia,A Phase 1/2 Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom's Macroglobulinemia,TERMINATED,,PHASE1,13.0,ACTUAL,Dana-Farber Cancer Institute,,3.0,,Sponsor decision to end follow-up early,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,OTHER,,,,,,,2022,0.0
NCT03616912,,2018-08-01,2022-10-11,,2023-01-04,2018-08-01,2018-08-06,ACTUAL,2023-01-04,2023-01-30,ACTUAL,,,,2023-01-04,2023-01-30,ACTUAL,2018-08-02,ACTUAL,2018-08-02,2023-01,2023-01-31,2022-03-09,ACTUAL,2022-03-09,2021-11-01,ACTUAL,2021-11-01,,INTERVENTIONAL,SLE-BRAVE I,All randomized participants who receive at least one dose of study drug. One investigational site with seven participants was excluded from analysis due to confirmed misconduct.,A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus,"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus",TERMINATED,,PHASE3,830.0,ACTUAL,Eli Lilly and Company,One investigational site with seven participants was excluded from analysis due to confirmed misconduct.~Study terminated due to insufficient evidence to support a positive benefit: risk profile in systemic lupus erythematosus patients.,6.0,,Study terminated due to insufficient evidence to support a positive benefit: risk profile in systemic lupus erythematosus patients.,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://trials.lillytrialguide.com/en-US/trial/64a5deI4M0sSScwYIMISsIDescriptionAStudyofBaricitinib(LY3009104)inParticipantsWithSystemicLupusErythematosus,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,INDUSTRY,,,,,,,2022,0.0
NCT03523117,,2018-04-17,2021-10-27,,2022-05-26,2018-05-01,2018-05-14,ACTUAL,2022-05-26,2022-06-22,ACTUAL,,,,2022-05-26,2022-06-22,ACTUAL,2019-01-31,ACTUAL,2019-01-31,2022-05,2022-05-31,2021-01-29,ACTUAL,2021-01-29,2020-12-22,ACTUAL,2020-12-22,,INTERVENTIONAL,,,Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA,"A Multicenter, Randomized, Active-Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia",COMPLETED,,PHASE3,79.0,ACTUAL,"American Regent, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,INDUSTRY,,,,,,,2021,1.0
NCT03448978,,2018-01-24,,,2024-06-28,2018-02-27,2018-02-28,ACTUAL,,,,,,,2024-06-28,2024-07-01,ACTUAL,2018-03-08,ACTUAL,2018-03-08,2024-06,2024-06-30,2021-06-03,ACTUAL,2021-06-03,2021-04-19,ACTUAL,2021-04-19,,INTERVENTIONAL,,,Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma,Phase I Safety and Feasibility Study of Autologous CD8+ T-cells Transiently Expressing a Chimeric Antigen Receptor Directed to B-Cell Maturation Antigen in Patients With Multiple Myeloma,TERMINATED,,PHASE1,32.0,ACTUAL,Cartesian Therapeutics,,1.0,,Phase 1 enrollment completed. Further clinical development terminated,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,INDUSTRY,,,,,,,2021,0.0
NCT03172936,,2017-05-30,,,2022-04-27,2017-05-31,2017-06-01,ACTUAL,,,,,,,2022-04-27,2022-05-03,ACTUAL,2017-09-08,ACTUAL,2017-09-08,2022-04,2022-04-30,2020-12-18,ACTUAL,2020-12-18,2020-12-18,ACTUAL,2020-12-18,,INTERVENTIONAL,,,Study of the Safety and Efficacy of MIW815 With PDR001 in Patients With Advanced/Metastatic Solid Tumors or Lymphomas,"A Phase Ib, Open Label, Multicenter Study of the Safety and Efficacy of MIW815 (ADU-S100) Administered by Intratumoral Injection With PDR001 to Patients With Advanced/Metastatic Solid Tumors or Lymphomas",TERMINATED,,PHASE1,106.0,ACTUAL,Novartis,,2.0,,Sponsor's decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,INDUSTRY,,,,,,,2020,0.0
NCT03898661,,2019-03-29,,,2023-09-07,2019-04-01,2019-04-02,ACTUAL,,,,,,,2023-09-07,2023-09-13,ACTUAL,2019-03-29,ACTUAL,2019-03-29,2023-09,2023-09-30,2021-01-01,ACTUAL,2021-01-01,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,Collagenase Clostridium Histolyticum for Refractory Iatrogenic Esophageal Strictures,Local Injection of Collagenase Clostridium Histolyticum (XiapexR) for Refractory Iatrogenic Esophageal Strictures: an Open-label Pilot Study,TERMINATED,,EARLY_PHASE1,2.0,ACTUAL,"University Hospital, Ghent",,1.0,,unexpected serious adverse event,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,OTHER,,,,,,,2021,0.0
NCT02504268,,2015-07-20,2019-01-16,2017-12-06,2021-06-25,2015-07-20,2015-07-21,ESTIMATED,2019-04-04,2019-04-08,ACTUAL,2017-12-06,2017-12-08,ACTUAL,2021-06-25,2021-06-28,ACTUAL,2015-09-03,ACTUAL,2015-09-03,2021-06,2021-06-30,2020-03-19,ACTUAL,2020-03-19,2017-01-16,ACTUAL,2017-01-16,,INTERVENTIONAL,AVERT-2,,Effects of Abatacept in Patients With Early Rheumatoid Arthritis,"A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive",COMPLETED,,PHASE3,994.0,ACTUAL,Bristol-Myers Squibb,,4.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,INDUSTRY,,,,,,,2020,1.0
NCT04504370,,2020-08-05,,,2023-07-27,2020-08-05,2020-08-07,ACTUAL,,,,,,,2023-07-27,2023-07-28,ACTUAL,2020-04-27,ACTUAL,2020-04-27,2023-07,2023-07-31,2022-11-28,ACTUAL,2022-11-28,2022-03-30,ACTUAL,2022-03-30,,INTERVENTIONAL,PB119,,Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects,"A Phase III, Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects",COMPLETED,,PHASE3,273.0,ACTUAL,"PegBio Co., Ltd.",,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,OTHER,,,,,,,2022,1.0
NCT04456049,,2020-07-01,,,2022-08-07,2020-07-01,2020-07-02,ACTUAL,,,,,,,2022-08-07,2022-08-10,ACTUAL,2020-08-24,ACTUAL,2020-08-24,2022-08,2022-08-31,2021-06-09,ACTUAL,2021-06-09,2021-06-09,ACTUAL,2021-06-09,,INTERVENTIONAL,,,Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-1,COVID_ENZA Trial: Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-1,TERMINATED,,PHASE2,7.0,ACTUAL,"Ente Ospedaliero Cantonale, Bellinzona",,2.0,,Low accrual,f,,,,f,f,f,,,,,,,,,,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,OTHER,,,,,,,2021,0.0
NCT03361319,,2017-11-22,,,2020-11-20,2017-11-28,2017-12-04,ACTUAL,,,,,,,2020-11-20,2020-11-24,ACTUAL,2020-07,ESTIMATED,2020-07-31,2020-11,2020-11-30,2023-07,ESTIMATED,2023-07-31,2023-07,ESTIMATED,2023-07-31,,INTERVENTIONAL,N3,,Combination Nab-paclitaxel (N-P) and Nintedanib or N-P and Placebo in Relapsed NSCLC Adenocarcinoma,A Phase I Trial of Combination Nab-Paclitaxel and Nintedanib or Nab-paclitaxel and Placebo in Relapsed Non-Small Cell Lung Cancer Adenocarcinoma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Royal Marsden NHS Foundation Trust,,3.0,,Withdrawal of financial support from funder,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,OTHER,,,,,,,2023,0.0
NCT05233436,,2022-01-06,,,2024-05-29,2022-01-31,2022-02-10,ACTUAL,,,,,,,2024-05-29,2024-05-31,ACTUAL,2022-02-24,ACTUAL,2022-02-24,2024-05,2024-05-31,2023-10-16,ACTUAL,2023-10-16,2023-10-16,ACTUAL,2023-10-16,,INTERVENTIONAL,,,PF-07265028 As Single Agent And In Combination With Sasanlimab in Advanced or Metastatic Solid Tumors,"A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-07265028 AS A SINGLE AGENT AND IN COMBINATION WITH SASANLIMAB EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07265028 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS",TERMINATED,,PHASE1,21.0,ACTUAL,Pfizer,,8.0,,Study terminated based on internal business considerations and was not based on safety reasons,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,INDUSTRY,,,,,,,2023,0.0
NCT03635983,,2018-08-16,2022-11-18,,2024-06-06,2018-08-16,2018-08-17,ACTUAL,2022-11-18,2022-12-19,ACTUAL,,,,2024-06-06,2024-06-21,ACTUAL,2018-09-21,ACTUAL,2018-09-21,2024-06,2024-06-30,2024-03-19,ACTUAL,2024-03-19,2021-11-19,ACTUAL,2021-11-19,,INTERVENTIONAL,,,A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma,"A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma",COMPLETED,,PHASE3,783.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,INDUSTRY,,,,,,,2024,1.0
NCT04847674,,2021-04-05,2023-04-06,,2023-05-12,2021-04-15,2021-04-19,ACTUAL,2023-05-12,2023-06-08,ACTUAL,,,,2023-05-12,2023-06-08,ACTUAL,2021-05-04,ACTUAL,2021-05-04,2023-05,2023-05-31,2022-04-28,ACTUAL,2022-04-28,2022-04-28,ACTUAL,2022-04-28,,INTERVENTIONAL,,The intent-to-treat (ITT) analysis set included all randomized participants.,A Study to Test if TEV-53275 is Effective in Relieving Asthma,"A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Safety, Efficacy and Pharmacodynamics of TEV 53275 Administered Subcutaneously in Adult Patients With Persistent Eosinophilic Asthma",TERMINATED,,PHASE2,97.0,ACTUAL,"Teva Branded Pharmaceutical Products R&D, Inc.",,3.0,,Stopped for strategic reasons,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request",2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,INDUSTRY,,,,,,,2022,0.0
NCT04220632,,2020-01-04,,,2020-10-27,2020-01-04,2020-01-07,ACTUAL,,,,,,,2020-10-27,2020-10-29,ACTUAL,2020-06-18,ACTUAL,2020-06-18,2020-10,2020-10-31,2020-10-10,ACTUAL,2020-10-10,2020-10-10,ACTUAL,2020-10-10,,INTERVENTIONAL,,,A Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease,"An Open Label, Multicenter, Phase I/II Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease",TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,1.0,,Adverse events of the first patient,f,,,,f,f,f,,,,,,,,,,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,INDUSTRY,,,,,,,2020,0.0
NCT03400033,,2018-01-08,2021-06-18,,2021-06-18,2018-01-08,2018-01-17,ACTUAL,2021-06-18,2021-07-12,ACTUAL,,,,2021-06-18,2021-07-12,ACTUAL,2018-09-05,ACTUAL,2018-09-05,2021-06,2021-06-30,2020-06-19,ACTUAL,2020-06-19,2020-06-19,ACTUAL,2020-06-19,,INTERVENTIONAL,,,Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD),"A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs",COMPLETED,,PHASE3,407.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,t,t,f,,,,,,IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,INDUSTRY,,,,,,,2020,1.0
NCT03416335,,2018-01-24,2023-08-31,,2024-05-03,2018-01-24,2018-01-31,ACTUAL,2024-05-03,2024-05-30,ACTUAL,,,,2024-05-03,2024-05-30,ACTUAL,2018-06-01,ACTUAL,2018-06-01,2024-05,2024-05-31,2022-12-20,ACTUAL,2022-12-20,2022-12-20,ACTUAL,2022-12-20,,INTERVENTIONAL,,,A Study of DSP-0509 in Patients With Advanced Solid Tumors to Determine the Safety and the Pharmacokinetic Profile,"A First-in-Human Phase 1/2 Trial to Determine the Safety and the Pharmacokinetic Profile of DSP-0509, a Synthetic Toll-Like Receptor 7 (TLR-7) Agonist, Administered as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,36.0,ACTUAL,"Sumitomo Pharma America, Inc.","The sponsor made the decision to terminate the study on August 2022 with all patients removed from treatment and follow-up by December 2022. Consistent with Food and Drug Administration and International Council for Harmonisation guidance on the content for abbreviated and synoptic CSRs, only safety data are analyzed and reported.",3.0,,Sponsor's decision to terminate the development of the program due to changing landscape.,f,,,,,t,f,,,,,,,,,,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,INDUSTRY,,,,,,,2022,0.0
NCT01740427,,2012-11-26,2016-10-21,,2023-11-27,2012-11-30,2012-12-04,ESTIMATED,2017-03-16,2017-04-26,ACTUAL,,,,2023-11-27,2023-11-30,ACTUAL,2013-02-22,ACTUAL,2013-02-22,2023-11,2023-11-30,2023-11-09,ACTUAL,2023-11-09,2016-02-26,ACTUAL,2016-02-26,,INTERVENTIONAL,,"The intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.",A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2),"A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE",COMPLETED,,PHASE3,666.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,INDUSTRY,,,,,,,2023,1.0
NCT04327986,,2020-03-28,2022-03-21,,2022-04-19,2020-03-28,2020-03-31,ACTUAL,2022-04-19,2022-05-18,ACTUAL,,,,2022-04-19,2022-05-18,ACTUAL,2021-06-15,ACTUAL,2021-06-15,2022-04,2022-04-30,2022-02-03,ACTUAL,2022-02-03,2022-01-18,ACTUAL,2022-01-18,,INTERVENTIONAL,,,Immune Checkpoint Inhibitor M7824 and the Immunocytokine M9241 in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Advanced Pancreas Cancer,A Phase I/II Study of the Immune Checkpoint Inhibitor M7824 and the Immunocytokine M9241 in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Advanced Pancreas Cancer,TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,Study closed to accrual due to the worsening risk: benefit ratio for participants receiving bintrafusp alfa (M7824).,f,,,,f,t,f,,,,,,Genomic data are available once genomic data are uploaded per protocol genomic data sharing (GDS) plan for as long as database is active.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).~Genomic data are made available via database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.,,YES,"All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to database of Genotypes and Phenotypes (dbGaP).",2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,NIH,,,,,,,2022,0.0
NCT02971683,,2016-11-21,2021-07-22,,2023-10-26,2016-11-22,2016-11-23,ESTIMATED,2021-08-23,2021-09-17,ACTUAL,,,,2023-10-26,2023-10-30,ACTUAL,2017-05-04,ACTUAL,2017-05-04,2023-10,2023-10-31,2022-08-02,ACTUAL,2022-08-02,2020-07-27,ACTUAL,2020-07-27,,INTERVENTIONAL,,,Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy,"A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC With Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy (IIM)",COMPLETED,,PHASE3,149.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,INDUSTRY,,,,,,,2022,1.0
NCT02124902,,2014-04-24,2022-10-12,,2022-10-12,2014-04-24,2014-04-28,ESTIMATED,2022-10-12,2022-11-07,ACTUAL,,,,2022-10-12,2022-11-07,ACTUAL,2014-07-07,ACTUAL,2014-07-07,2022-10,2022-10-31,2021-12-31,ACTUAL,2021-12-31,2021-11-10,ACTUAL,2021-11-10,,INTERVENTIONAL,,,Neoadjuvant Treatment of Triple Negative Breast Cancer Patients With Docetaxel and Carboplatin to Assess Anti-tumor Activity,A Co-clinical Trial in Triple Negative Breast Cancer Patients With Genoproteomic Discovery,TERMINATED,,PHASE2,148.0,ACTUAL,Washington University School of Medicine,,2.0,,Insufficient funding/staff,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,OTHER,,,,,,,2021,0.0
NCT02876003,,2016-08-18,,,2017-02-22,2016-08-18,2016-08-23,ESTIMATED,,,,,,,2017-02-22,2017-02-24,ACTUAL,2016-09,,2016-09-30,2017-02,2017-02-28,2020-10,ESTIMATED,2020-10-31,2019-10,ESTIMATED,2019-10-31,,INTERVENTIONAL,,,Efficacy and Safety of G-202 in PSMA-Positive Glioblastoma,"An Open-Label, Single-Arm, Phase II Study to Evaluate the Efficacy, Safety and CNS Exposure of G-202 in Patients With PSMA Positive Recurrent or Progressive Glioblastoma",WITHDRAWN,,PHASE2,0.0,ACTUAL,"GenSpera, Inc.",,1.0,,This study has been withdrawn prior to enrollment.,f,,,,f,,,,,,,,,,,NO,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,INDUSTRY,,,,,,,2020,0.0
NCT04044352,,2019-08-01,2021-02-25,,2021-04-01,2019-08-01,2019-08-05,ACTUAL,2021-04-01,2021-04-28,ACTUAL,,,,2021-04-01,2021-04-28,ACTUAL,2019-10-22,ACTUAL,2019-10-22,2020-12-29,2020-12-29,2020-03-02,ACTUAL,2020-03-02,2020-03-02,ACTUAL,2020-03-02,,INTERVENTIONAL,,,H1N1v Virus Challenge Study in Healthy Subjects,A Controlled Human Infection Study of Influenza A/Bethesda/MM2/H1N1 Virus (A/California/04/2009/H1N1-like) in Healthy Subjects to Assess the Effect of Pre-Existing Immunity on Symptomatic Influenza Virus Infection,COMPLETED,,PHASE1,76.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,1.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,NIH,,,,,,,2020,1.0
NCT02733614,,2016-03-29,,,2021-10-25,2016-04-05,2016-04-11,ESTIMATED,,,,,,,2021-10-25,2021-11-01,ACTUAL,2016-12,ACTUAL,2016-12-31,2021-10,2021-10-31,2021-03-31,ACTUAL,2021-03-31,2020-10,ACTUAL,2020-10-31,,INTERVENTIONAL,,,Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD,A Proof of Concept (POC) Clinical Trial for Post-Traumatic Stress Disorder (PTSD) With a First-In-Class Vasopressin 1a Receptor Antagonist (SRX246),TERMINATED,,PHASE2,33.0,ACTUAL,Azevan Pharmaceuticals,,2.0,,funding,f,,,,t,,,,,,,,,,,NO,,2024-10-16 08:13:13.772024,2024-10-16 08:13:13.772024,INDUSTRY,,,,,,,2021,0.0
NCT04448899,,2020-06-24,,,2021-08-03,2020-06-24,2020-06-26,ACTUAL,,,,,,,2021-08-03,2021-08-04,ACTUAL,2020-06-01,ACTUAL,2020-06-01,2021-08,2021-08-31,2021-02-05,ACTUAL,2021-02-05,2021-02-01,ACTUAL,2021-02-01,,INTERVENTIONAL,,,Ivabradine in Patients With Congestive Heart Failure,Effects of Ivabradine on Neopterin and NT-Pro BNP in Patients With Congestive Heart Failure,COMPLETED,,PHASE4,60.0,ACTUAL,Damanhour University,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,OTHER,,,,,,,2021,1.0
NCT03707418,,2018-10-11,,,2021-01-14,2018-10-11,2018-10-16,ACTUAL,,,,,,,2021-01-14,2021-01-19,ACTUAL,2021-04,ESTIMATED,2021-04-30,2020-04,2020-04-30,2021-06,ESTIMATED,2021-06-30,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,Bivalirudin vs Heparin in ECMO Patients,A Randomized Study Comparing Bivalirudin vs Heparin in Patients With Extracorporeal Membrane Oxygenator (ECMO) Support,WITHDRAWN,,PHASE1,0.0,ACTUAL,Johns Hopkins University,,2.0,,unable to secure funding,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,OTHER,,,,,,,2021,0.0
NCT02490878,,2015-07-02,2020-04-24,,2023-02-23,2015-07-06,2015-07-07,ESTIMATED,2021-07-15,2021-08-06,ACTUAL,,,,2023-02-23,2023-03-23,ACTUAL,2016-04,ACTUAL,2016-04-30,2023-02,2023-02-28,2022-12-15,ACTUAL,2022-12-15,2019-02-01,ACTUAL,2019-02-01,,INTERVENTIONAL,,,Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BEST) for Radionecrosis After Radiosurgery for Brain Metastases,Randomized Phase II Study: Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BEST) for Radionecrosis After Radiosurgery for Brain Metastases,TERMINATED,,PHASE2,19.0,ACTUAL,Alliance for Clinical Trials in Oncology,,2.0,,Slow accrual,f,,,,t,,,,,,,,,,,,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,OTHER,,,,,,,2022,0.0
NCT03436953,,2018-02-07,,,2021-05-27,2018-02-12,2018-02-19,ACTUAL,,,,,,,2021-05-27,2021-05-28,ACTUAL,2019-12,ESTIMATED,2019-12-31,2021-05,2021-05-31,2020-12,ESTIMATED,2020-12-31,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,A Phase 2 Study of CX-8998 in Adults With Tremor Associated With Parkinson's Disease,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of CX-8998 for Tremor Associated With Parkinson's Disease",WITHDRAWN,,PHASE2,0.0,ACTUAL,Jazz Pharmaceuticals,,2.0,,The program was not initiated nor were any patients ever enrolled. The investigations detailed in the submitted protocol were incorporated into another program.,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,INDUSTRY,,,,,,,2020,0.0
NCT05361083,,2022-04-22,,,2022-04-29,2022-04-29,2022-05-04,ACTUAL,,,,,,,2022-04-29,2022-05-04,ACTUAL,2019-09-01,ACTUAL,2019-09-01,2022-04,2022-04-30,2022-02-28,ACTUAL,2022-02-28,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,,,First-in-human Evaluation of [18F]CETO,Studies of 18F-CETO as a Tracer for Adrenal PET Diagnostics,COMPLETED,,EARLY_PHASE1,20.0,ACTUAL,Uppsala University,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,OTHER,,,,,,,2022,1.0
NCT04462757,,2020-06-12,,,2021-04-27,2020-07-07,2020-07-08,ACTUAL,,,,,,,2021-04-27,2021-04-30,ACTUAL,2020-05-28,ACTUAL,2020-05-28,2021-04,2021-04-30,2020-12-23,ACTUAL,2020-12-23,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,SCIL_COV19,,SCIL-1Ra in COVID-19 Feasibility & PK/PD,Subcutaneous and Intravenous IL-1Ra (Anakinra) in COVID-19 Infection - Feasibility & Pharmacokinetics/Pharmacodynamics Study,TERMINATED,,PHASE2,5.0,ACTUAL,University of Manchester,,2.0,,Lack of patients in the trial population from which to recruit and lack of funding,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,OTHER,,,,,,,2020,0.0
NCT02331095,,2014-12-22,2020-06-16,,2020-09-23,2014-12-31,2015-01-06,ESTIMATED,2020-09-23,2020-10-19,ACTUAL,,,,2020-09-23,2020-10-19,ACTUAL,2015-01,,2015-01-31,2020-09,2020-09-30,2020-05-20,ACTUAL,2020-05-20,2017-10-27,ACTUAL,2017-10-27,,INTERVENTIONAL,,,Statin Use in Patients With Acute VTE,A Pilot Study of Using Statins in Patients With Acute Venous Thromboembolism (VTE),TERMINATED,,EARLY_PHASE1,21.0,ACTUAL,Ohio State University,"Our study was limited by the small sample size, early termination due to low recruitment rate and lack of funding. The protocol was amended to include patients on rivaroxaban (initially only warfarin). Lost to follow up is also significant.",2.0,,Low recruitment,f,,,,f,,,,,,,,,,,,,2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,OTHER,,,,,,,2020,0.0
NCT03398434,,2018-01-08,,,2020-10-05,2018-01-08,2018-01-12,ACTUAL,,,,,,,2020-10-05,2020-10-08,ACTUAL,2018-10-16,ESTIMATED,2018-10-16,2020-10,2020-10-31,2020-01-30,ESTIMATED,2020-01-30,2019-11-28,ESTIMATED,2019-11-28,,INTERVENTIONAL,,,Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation,"A Multicenter, Randomized, Open-label, Active-controlled, Dose-range Finding Study to Assess the Pharmacodynamic Parameters, Safety and Tolerability of MAA868 and Its Effect on Thrombogenesis Biomarkers Compared to Apixaban in Patients With Atrial Fibrillation",WITHDRAWN,,PHASE2,0.0,ACTUAL,Novartis,,4.0,,Trial cancelled before First Patient First Visit (no patient enrolled),f,,,,t,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,INDUSTRY,,,,,,,2020,0.0
NCT05027516,,2021-07-20,2023-06-05,,2024-02-15,2021-08-24,2021-08-30,ACTUAL,2024-02-15,2024-08-02,ACTUAL,,,,2024-02-15,2024-08-02,ACTUAL,2022-01-17,ACTUAL,2022-01-17,2024-02,2024-02-29,2022-05-09,ACTUAL,2022-05-09,2022-05-09,ACTUAL,2022-05-09,,INTERVENTIONAL,ResistAZM,,Trial Comparing Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Gonorrhea,An Open Label Randomized Controlled Trial Comparing the Effect of Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Neisseria Gonorrhoeae on the Resistome,COMPLETED,,PHASE4,42.0,ACTUAL,"Institute of Tropical Medicine, Belgium",,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,OTHER,,,,,,,2022,1.0
NCT05125562,,2021-11-11,,,2024-02-09,2021-11-16,2021-11-18,ACTUAL,,,,,,,2024-02-09,2024-02-13,ACTUAL,2022-12-07,ESTIMATED,2022-12-07,2024-02,2024-02-29,2023-03-07,ESTIMATED,2023-03-07,2023-03-07,ESTIMATED,2023-03-07,,INTERVENTIONAL,,,Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19,Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19: A Phase II Clinical Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Direct Biologics, LLC",,3.0,,Sponsor has withdrawn/closed the IND with the FDA. A letter dated 21NOV2022 was submitted to the FDA.,t,,,,,t,f,,,,,,,,,NO,,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,INDUSTRY,,NCT04657458,AVAILABLE,,,,2023,0.0
NCT02702401,,2016-03-03,2020-01-31,,2022-08-30,2016-03-03,2016-03-08,ESTIMATED,2020-01-31,2020-02-17,ACTUAL,,,,2022-08-30,2022-09-29,ACTUAL,2016-05-26,ACTUAL,2016-05-26,2022-08,2022-08-31,2021-09-22,ACTUAL,2021-09-22,2019-01-02,ACTUAL,2019-01-02,,INTERVENTIONAL,,The baseline characteristics population includes all randomized participants.,Study of Pembrolizumab (MK-3475) vs. Best Supportive Care in Participants With Previously Systemically Treated Advanced Hepatocellular Carcinoma (MK-3475-240/KEYNOTE-240),A Phase III Study of Pembrolizumab (MK-3475) vs. Best Supportive Care as Second-Line Therapy in Subjects With Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-240),COMPLETED,,PHASE3,413.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,,,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,INDUSTRY,,,,,,,2021,1.0
NCT04003818,,2019-06-06,,,2022-04-21,2019-06-28,2019-07-01,ACTUAL,,,,,,,2022-04-21,2022-04-25,ACTUAL,2020-05-15,ACTUAL,2020-05-15,2022-04,2022-04-30,2021-03-10,ACTUAL,2021-03-10,2021-01-21,ACTUAL,2021-01-21,,INTERVENTIONAL,,,Efficacy and Safety of Teicoplanin in CDAD,"Prospective, Interventional, Phase IV Study, Evaluating the Efficacy and Safety of Teicoplanin (100-200 mg, Administered Orally Twice a Day) in Patients With Clostridium Difficile Infection-associated Diarrhea and Colitis",TERMINATED,,PHASE4,50.0,ACTUAL,Sanofi,,1.0,,"Due to COVID-19 and great challenges during patient enrolment period, current status of this study is far behind the plan. The study cannot be completed according to the plan. Sanofi decides to terminate the study upon comprehensive assessment.",f,,,,f,f,f,,,f,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,INDUSTRY,,,,,,,2021,0.0
NCT03812588,,2019-01-15,2022-02-28,,2022-03-28,2019-01-17,2019-01-23,ACTUAL,2022-03-28,2022-04-21,ACTUAL,,,,2022-03-28,2022-04-21,ACTUAL,2019-01-30,ACTUAL,2019-01-30,2022-03,2022-03-31,2021-08-01,ACTUAL,2021-08-01,2020-05-27,ACTUAL,2020-05-27,,INTERVENTIONAL,,,Contact: Developing New Clinical Management Strategies,Developing New Clinical Management Strategies for Antidepressant Treatments,COMPLETED,,PHASE4,29.0,ACTUAL,New York State Psychiatric Institute,"Due to challenges associated with the pandemic, the study was completed with a smaller sample size than originally intended.",4.0,,,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,OTHER,,,,,,,2021,1.0
NCT04627142,,2020-11-10,,,2022-04-19,2020-11-12,2020-11-13,ACTUAL,,,,,,,2022-04-19,2022-04-20,ACTUAL,2020-11-23,ACTUAL,2020-11-23,2022-04,2022-04-30,2022-01-18,ACTUAL,2022-01-18,2022-01-18,ACTUAL,2022-01-18,,INTERVENTIONAL,,,A Study to Test Different Doses of BI 1701963 in Combination With Irinotecan in People With Advanced Bowel Cancer With Kirsten Rat Sarcoma Viral Oncogene Homologue (KRAS) Mutation,A Phase 1 Open-label Dose Escalation Trial of BI 1701963 in Combination With Irinotecan in KRAS Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer,TERMINATED,,PHASE1,15.0,ACTUAL,Boehringer Ingelheim,,2.0,,Sponsor decision,f,,,,f,f,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,INDUSTRY,,,,,,,2022,0.0
NCT02659020,,2016-01-15,2021-07-26,,2022-04-15,2016-01-15,2016-01-20,ESTIMATED,2021-09-14,2021-10-11,ACTUAL,,,,2022-04-15,2022-05-09,ACTUAL,2016-03-01,ACTUAL,2016-03-01,2022-04,2022-04-30,2021-04-27,ACTUAL,2021-04-27,2020-07-28,ACTUAL,2020-07-28,,INTERVENTIONAL,ANNOUNCE 2,All participants from phase 1b/2.,A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma,"A Phase 1b (Open-Label)/Phase 2 (Randomized, Double-Blinded) Study Evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma",COMPLETED,,PHASE1/PHASE2,310.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,t,t,,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 11:15:36.688327,2024-10-15 11:15:36.688327,INDUSTRY,,,,,,,2021,1.0
NCT04117477,,2019-10-03,,,2023-02-03,2019-10-03,2019-10-07,ACTUAL,,,,,,,2023-02-03,2023-02-08,ACTUAL,2019-09-27,ACTUAL,2019-09-27,2023-02,2023-02-28,2021-03-20,ACTUAL,2021-03-20,2021-03-20,ACTUAL,2021-03-20,,INTERVENTIONAL,,,Xylitol - Healthcare Associated Infection Reduction in Stem Cell Transplant Patients,"Healthcare Associated Infection Reduction in Stem Cell Transplant Patients: a Randomized, Double-blind, Placebo-controlled Study Evaluating Twice Daily Xylitol Administration",TERMINATED,,PHASE2,46.0,ACTUAL,"Children's Hospital Medical Center, Cincinnati",,2.0,,A new multisite study was opened in place of this study.,f,,,,f,f,f,,,f,,,,,,,,2024-10-15 22:07:09.305756,2024-10-15 22:07:09.305756,OTHER,,,,,,,2021,0.0
NCT03589885,,2018-07-05,2021-07-12,2020-02-12,2021-10-07,2018-07-05,2018-07-18,ACTUAL,2021-08-05,2021-08-26,ACTUAL,2021-08-05,2021-08-26,ACTUAL,2021-10-07,2021-10-11,ACTUAL,2018-12-19,ACTUAL,2018-12-19,2021-10,2021-10-31,2020-08-05,ACTUAL,2020-08-05,2019-11-19,ACTUAL,2019-11-19,,INTERVENTIONAL,MATURE,Full Analysis set (FAS) consisted of 122 subjects and used for efficacy analyses.,Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis,"Multicenter, rAndomized, Double-blind, Placebo-conTrolled, 52-week stUdy to demonstRatE the Efficacy, Safety and Tolerability of Secukinumab Injections With 2 mL Auto-injectors (300 mg) in Adult Subjects With Plaque Psoriasis",COMPLETED,,PHASE3,122.0,ACTUAL,Novartis,,4.0,,,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,INDUSTRY,,,,,,,2020,1.0
NCT04681729,,2020-12-18,2024-01-29,,2024-01-29,2020-12-18,2020-12-23,ACTUAL,2024-01-29,2024-02-21,ACTUAL,,,,2024-01-29,2024-02-21,ACTUAL,2020-12-10,ACTUAL,2020-12-10,2023-05-02,2023-05-02,2023-04-20,ACTUAL,2023-04-20,2023-02-02,ACTUAL,2023-02-02,,INTERVENTIONAL,,Randomized population consisted of all participants from the screened population who had been allocated to randomized intervention by interactive response technology regardless of whether the treatment kit was used or not.,Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS),"A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study of Dupilumab in Patients With Chronic Inducible Cold Urticaria Who Remain Symptomatic Despite the Use of H1-antihistamine Treatment",COMPLETED,,PHASE3,82.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,INDUSTRY,,,,,,,2023,1.0
NCT04534842,,2020-08-24,,,2022-10-14,2020-08-27,2020-09-01,ACTUAL,,,,,,,2022-10-14,2022-10-17,ACTUAL,2020-08-25,ACTUAL,2020-08-25,2022-10,2022-10-31,2022-10-07,ACTUAL,2022-10-07,2022-10-07,ACTUAL,2022-10-07,,INTERVENTIONAL,SynPheny-1,,Efficacy and Safety of SYNB1618 and SYNB1934 in Adult Patients With Phenylketonuria,An Open-label Study of the Efficacy and Safety of SYNB1618 and SYNB1934 in Patients With Phenylketonuria (SynPheny-1),COMPLETED,,PHASE2,20.0,ACTUAL,Synlogic,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,INDUSTRY,,,,,,,2022,1.0
NCT03563742,,2018-05-28,,,2022-06-23,2018-06-19,2018-06-20,ACTUAL,,,,,,,2022-06-23,2022-06-29,ACTUAL,2018-09-24,ACTUAL,2018-09-24,2022-06,2022-06-30,2021-06-28,ACTUAL,2021-06-28,2021-06-28,ACTUAL,2021-06-28,,INTERVENTIONAL,RISE,,A Study to Determine the Safety and Efficacy of Rilpivirine in Treatment-naive Indian Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection,Open-Label Study With Rilpivirine in Treatment-naïve Indian Subjects With HIV-1 Infection to Determine Safety and Efficacy,TERMINATED,,PHASE3,58.0,ACTUAL,Johnson & Johnson Pte Ltd,,1.0,,High SF rate (less treatment-naïve subjects \& subjects with viral load \<100000). Reevaluation in scientific position in India after internal discussion.,f,,,,f,f,f,,,,,,,,,,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,INDUSTRY,,,,,,,2021,0.0
NCT05611086,,2022-11-01,,,2022-11-07,2022-11-07,2022-11-09,ACTUAL,,,,,,,2022-11-07,2022-11-09,ACTUAL,2019-08-29,ACTUAL,2019-08-29,2022-11,2022-11-30,2020-12-03,ACTUAL,2020-12-03,2020-12-03,ACTUAL,2020-12-03,,INTERVENTIONAL,,,N-Acetylcysteine vs Placebo as Adjunctive Treatment in Pediatric Leukemia,"N-Acetylcysteine vs Placebo as Adjunctive Treatment in Pediatric Leukemia: A Single Blind, Randomized Controlled Trial",TERMINATED,,PHASE4,16.0,ACTUAL,Dr Cipto Mangunkusumo General Hospital,,2.0,,The study stopped because the study period already ended,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,OTHER,,,,,,,2020,0.0
NCT04809805,,2021-03-05,,,2023-12-08,2021-03-19,2021-03-22,ACTUAL,,,,,,,2023-12-08,2023-12-14,ACTUAL,2021-04-15,ACTUAL,2021-04-15,2023-11,2023-11-30,2023-04-27,ACTUAL,2023-04-27,2022-11-09,ACTUAL,2022-11-09,,INTERVENTIONAL,,,"A Study to Learn How Safe BAY2666605 is, How it Affects the Body, How it Moves Into, Through and Out of the Body, the Maximum Amount That Can be Given and Its Action Against Tumors in Adult Participants With Skin Cancer That Has Spread to Other Parts of the Body and Other Types of Advanced Cancer","An Open Label, Phase 1, First-in-human, Study to Evaluate Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics and Tumor Response Profile of Schlafen12 Complex Inducer (SLFN12 ci) BAY 2666605 in Participants With Metastatic Melanoma and Other Advanced Solid Tumors.",TERMINATED,,PHASE1,5.0,ACTUAL,Bayer,,2.0,,Due to the high probability of not achieving a therapeutic window and lack of evidence of sufficient clinical benefit.,,,,,f,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-14 21:22:01.437344,2024-10-14 21:22:01.437344,INDUSTRY,,,,,,,2023,0.0
NCT03022045,,2017-01-13,2018-09-06,,2021-11-16,2017-01-13,2017-01-16,ESTIMATED,2018-09-06,2019-02-06,ACTUAL,,,,2021-11-16,2021-11-18,ACTUAL,2017-01-26,ACTUAL,2017-01-26,2021-11,2021-11-30,2020-11-19,ACTUAL,2020-11-19,2017-09-17,ACTUAL,2017-09-17,,INTERVENTIONAL,,,A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis,"A Phase 3, Randomized, Open-Label Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis",COMPLETED,,PHASE3,18.0,ACTUAL,AbbVie,,2.0,,,f,,,,t,f,f,,,,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,INDUSTRY,,,,,,,2020,1.0
NCT03566238,,2018-05-25,2021-07-12,,2021-08-10,2018-06-20,2018-06-25,ACTUAL,2021-08-10,2021-09-05,ACTUAL,,,,2021-08-10,2021-09-05,ACTUAL,2018-05-16,ACTUAL,2018-05-16,2021-08,2021-08-31,2020-07-28,ACTUAL,2020-07-28,2020-07-27,ACTUAL,2020-07-27,,INTERVENTIONAL,PEDFIC 1,,This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2,"A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1)",COMPLETED,,PHASE3,62.0,ACTUAL,AlbireoPharma,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,UNKNOWN,,,,,,,2020,1.0
NCT03386578,,2017-12-18,,,2024-07-12,2017-12-21,2017-12-29,ACTUAL,,,,,,,2024-07-12,2024-07-16,ACTUAL,2018-07-03,ACTUAL,2018-07-03,2024-07,2024-07-31,2024-02-24,ACTUAL,2024-02-24,2023-10-25,ACTUAL,2023-10-25,,INTERVENTIONAL,,,"Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum","Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention During Pregnancy and Postpartum in Adolescents and Young Women and Their Infants",COMPLETED,,PHASE2,390.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,4.0,,,f,,,,t,t,f,,,,,,Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.,* With whom?~  * Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.~* For what types of analyses?~  * To achieve aims in the proposal approved by the IMPAACT Network.~* By what mechanism will data be made available?~  * Researchers may submit a request for access to data using the IMPAACT Data Request form at: https://www.impaactnetwork.org/resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.,,YES,"Individual participant data that underlie results in the publication, after deidentification.",2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,NIH,,,,,,,2024,1.0
NCT03437330,,2017-12-21,,,2024-05-13,2018-02-12,2018-02-19,ACTUAL,,,,,,,2024-05-13,2024-05-16,ACTUAL,2021-10-27,ACTUAL,2021-10-27,2024-05,2024-05-31,2023-05-03,ACTUAL,2023-05-03,2023-05-03,ACTUAL,2023-05-03,,INTERVENTIONAL,,,Empagliflozin Effect on Glucose Toxicity,"Empagliflozin Effect on Glucose Toxicity in Type 2 Diabetes Patients - a Randomized, Open-label, Controlled, Parallel Group, Exploratory Study",WITHDRAWN,,PHASE4,0.0,ACTUAL,University Hospital Tuebingen,,2.0,,poor recruitment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 17:19:39.283941,2024-10-16 17:19:39.283941,OTHER,,,,,,,2023,0.0
NCT02351869,,2014-12-02,,,2023-04-04,2015-01-29,2015-01-30,ESTIMATED,,,,,,,2023-04-04,2023-04-06,ACTUAL,2015-08,,2015-08-31,2023-04,2023-04-30,2020-06-07,ACTUAL,2020-06-07,2020-02-01,ACTUAL,2020-02-01,,INTERVENTIONAL,,,Nitrous Oxide as a Putative Novel Dual-Mechanism Treatment for Bipolar Disorder,Nitrous Oxide as a Putative Novel Dual-Mechanism Treatment for Bipolar Disorder,TERMINATED,,PHASE2,25.0,ACTUAL,Sunnybrook Health Sciences Centre,,2.0,,This study was terminated due to COVID-19 pandemic-related halting of recruitment in the context of an upcoming replacement of the study MRI scanner.,f,,,,t,,,,,,,,,,,,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,OTHER,,,,,,,2020,0.0
NCT04126343,,2019-10-11,2021-05-21,,2021-05-21,2019-10-11,2019-10-15,ACTUAL,2021-05-21,2021-06-18,ACTUAL,,,,2021-05-21,2021-06-18,ACTUAL,2019-10-23,ACTUAL,2019-10-23,2021-05,2021-05-31,2020-05-22,ACTUAL,2020-05-22,2020-05-22,ACTUAL,2020-05-22,,INTERVENTIONAL,,Baseline Characteristics refer to the Safety Set which consisted of all study participants who received at least 1 dose of study medication.,A Study to Test the Cardiac Effects of Padsevonil in Healthy Study Participants,"A Single-Center, Randomized, Placebo-Controlled, 3 Treatment Period Crossover Study to Assess the Effect of Padsevonil on Cardiac Repolarization (QTc Interval) (Using Moxifloxacin as a Positive Control) in Healthy Study Participants",TERMINATED,,PHASE1,54.0,ACTUAL,UCB Pharma,,3.0,,"Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures",f,,,,f,f,f,,,,,,,,,NO,"Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.",2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,INDUSTRY,,,,,,,2020,0.0
NCT03734016,,2018-11-02,2023-07-07,,2024-03-28,2018-11-06,2018-11-07,ACTUAL,2023-07-26,2023-07-27,ACTUAL,,,,2024-03-28,2024-04-01,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2024-03,2024-03-31,2024-02-28,ACTUAL,2024-02-28,2022-08-08,ACTUAL,2022-08-08,,INTERVENTIONAL,ALPINE,Intent-to-Treat (ITT) Analysis Set includes all randomized participants,A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia,"A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared With Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma",COMPLETED,,PHASE3,652.0,ACTUAL,BeiGene,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,INDUSTRY,,,,,,,2024,1.0
NCT03809650,,2019-01-10,,,2021-06-16,2019-01-17,2019-01-18,ACTUAL,,,,,,,2021-06-16,2021-06-18,ACTUAL,2019-01-08,ACTUAL,2019-01-08,2021-03,2021-03-31,2020-06-29,ACTUAL,2020-06-29,2020-06-29,ACTUAL,2020-06-29,,INTERVENTIONAL,,,A Clinical Study to Find Out if Macitentan is Effective and Safe in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).,"A Prospective, Multicenter, Open-label, Single Arm, Phase III Study to Assess the Efficacy and Safety of Macitentan (ACT-064992) in Subjects With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)",TERMINATED,,PHASE3,9.0,ACTUAL,Actelion,,1.0,,Due to a change in the development strategy,f,,,,,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials\\transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu",2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,INDUSTRY,,,,,,,2020,0.0
NCT04410354,,2020-04-28,,,2020-12-04,2020-05-28,2020-06-01,ACTUAL,,,,,,,2020-12-04,2020-12-08,ACTUAL,2020-06-16,ACTUAL,2020-06-16,2020-12,2020-12-31,2020-12-01,ACTUAL,2020-12-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,,,Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination With Intravenous Remdesivir in Adult Patients With Advanced Coronavirus Disease 2019 (COVID-19)",TERMINATED,,PHASE2,44.0,ACTUAL,"ViralClear Pharmaceuticals, Inc.",,2.0,,Failure to meet primary endpoint,,,,,f,t,f,,,,,,,,,NO,,2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,INDUSTRY,,,,,,,2020,0.0
NCT02133183,,2014-05-06,,,2024-04-03,2014-05-06,2014-05-07,ESTIMATED,,,,,,,2024-04-03,2024-04-04,ACTUAL,2014-07-02,ACTUAL,2014-07-02,2024-04,2024-04-30,2023-10-31,ACTUAL,2023-10-31,2020-01-31,ACTUAL,2020-01-31,,INTERVENTIONAL,,,Sapanisertib Before and After Surgery in Treating Patients With Recurrent Glioblastoma,Pilot Study of MLN0128 (TAK-228) in Preoperative Recurrent Glioblastoma (GBM) Patients,TERMINATED,,PHASE1,40.0,ACTUAL,National Cancer Institute (NCI),,2.0,,Other - Lapse in funding,f,,,,f,,,,,,,,,,,,,2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,NIH,,,,,,,2023,0.0
NCT03712345,,2018-10-16,2022-03-18,,2022-05-03,2018-10-18,2018-10-19,ACTUAL,2022-05-03,2022-05-26,ACTUAL,,,,2022-05-03,2022-05-26,ACTUAL,2018-10-15,ACTUAL,2018-10-15,2022-05,2022-05-31,2021-05-03,ACTUAL,2021-05-03,2020-09-10,ACTUAL,2020-09-10,,INTERVENTIONAL,,Safety Analysis Set,Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA,"Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Efficacy and Safety Study of IFX-1 in Add-On to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)",TERMINATED,,PHASE2,20.0,ACTUAL,InflaRx GmbH,,3.0,,Due to COVID-19 pandemic outbreak and its impact on overall study activities. All efforts were made to ensure that participants that were enrolled and/or were still in the study will continue to receive treatment and follow-up until study completion.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,INDUSTRY,,,,,,,2021,0.0
NCT05148533,,2021-11-25,,,2024-04-11,2021-11-25,2021-12-08,ACTUAL,,,,,,,2024-04-11,2024-04-15,ACTUAL,2021-12-30,ACTUAL,2021-12-30,2024-04,2024-04-30,2023-02-03,ACTUAL,2023-02-03,2023-02-03,ACTUAL,2023-02-03,,INTERVENTIONAL,,,A Study of Single Drug TJ011133 and Toripalimab Combine Treatment for Advanced Solid Tumor,"A Phase I/II Dose Escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of TJ011133 in Combination With Toripalimab in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,"TJ Biopharma Co., Ltd.",,1.0,,Company Development strategy adjustment,f,,,,t,f,f,,,,,,,,,,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,INDUSTRY,,,,,,,2023,0.0
NCT04108962,,2019-09-24,,,2022-01-17,2019-09-27,2019-09-30,ACTUAL,,,,,,,2022-01-17,2022-02-01,ACTUAL,2019-12-23,ACTUAL,2019-12-23,2022-01,2022-01-31,2021-10-01,ACTUAL,2021-10-01,2021-09-24,ACTUAL,2021-09-24,,INTERVENTIONAL,,,Benralizumab in the Treatment of Patients With Severe Asthma With ABPA,"Phase IV, Single-Center, Open-Label Study Evaluating the Effects of an Anti-IL5 Receptor Alpha (Benralizumab) Monoclonal Antibody in the Treatment of Severe Asthma in Patients With Allergic Bronchopulmonary Aspergillosis",WITHDRAWN,,PHASE4,0.0,ACTUAL,Baylor Research Institute,,1.0,,Difficult to find eligible patients willing to participate.,f,,,,f,t,f,,,f,,,,,,NO,no subjects enrolled,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,OTHER,,,,,,,2021,0.0
NCT04123704,,2019-10-09,2024-06-24,,2024-07-31,2019-10-09,2019-10-11,ACTUAL,2024-07-31,2024-08-26,ACTUAL,,,,2024-07-31,2024-08-26,ACTUAL,2021-09-22,ACTUAL,2021-09-22,2024-06,2024-06-30,2023-01-22,ACTUAL,2023-01-22,2023-01-22,ACTUAL,2023-01-22,,INTERVENTIONAL,,,Sitravatinib in Metastatic Breast Cancer,"A Phase II Study of Sitravatinib in Metastatic, Pre-treated, Triple Negative Breast Cancer",TERMINATED,,PHASE2,3.0,ACTUAL,Baylor Breast Care Center,,1.0,,Terminated by sponsor due to lack of interest,f,,,,t,t,f,,,,,,,,,,,2024-10-14 21:22:01.437344,2024-10-14 21:22:01.437344,OTHER,,,,,,,2023,0.0
NCT02247128,,2014-09-19,,,2020-04-29,2014-09-19,2014-09-23,ESTIMATED,,,,,,,2020-04-29,2020-04-30,ACTUAL,2014-01,,2014-01-31,2020-04,2020-04-30,2020-04,ACTUAL,2020-04-30,2020-03,ACTUAL,2020-03-31,,INTERVENTIONAL,POPular-TAVI,,Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation,Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation,COMPLETED,,PHASE4,1016.0,ACTUAL,St. Antonius Hospital,,4.0,,,f,,,,t,,,,,,,,,,,,,2024-10-14 21:22:01.437344,2024-10-14 21:22:01.437344,OTHER,,,,,,,2020,1.0
NCT03829046,,2019-02-01,2023-01-24,,2023-03-06,2019-02-01,2019-02-04,ACTUAL,2023-03-06,2023-03-08,ACTUAL,,,,2023-03-06,2023-03-08,ACTUAL,2019-06-03,ACTUAL,2019-06-03,2023-03,2023-03-31,2021-11-15,ACTUAL,2021-11-15,2021-11-15,ACTUAL,2021-11-15,,INTERVENTIONAL,,,The Effects of Evolocumab in Patients With Diabetes and Atherosclerotic Vascular Disease,The Effects of Evolocumab on Endothelial and Inflammatory Biocellular Markers in Patients With Diabetes and Atherosclerotic Vascular Disease (METCHNIKOFF),COMPLETED,,PHASE4,41.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,2.0,,,f,,,,f,t,f,,,t,,,,,,UNDECIDED,This is a pilot study and all data from this trial will be used to support a bigger clinical trial to assess the role of PCSK9 inhibition in type 2 diabetes patients with cardiac microvascular dysfunction.,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,OTHER,,,,,,,2021,1.0
NCT02724904,,2016-01-14,,,2017-03-21,2016-03-24,2016-03-31,ESTIMATED,,,,,,,2017-03-21,2017-03-22,ACTUAL,2017-05,ESTIMATED,2017-05-31,2017-03,2017-03-31,2021-12,ESTIMATED,2021-12-31,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,Reduced Intensity Conditioning Allogeneic Hematopoietic Stem Cell Transplant (HSCT) For Lymphoma,A Pilot Study of Reduced Intensity Conditioning Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Relapsed CNS Involvement by Lymphoma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Massachusetts General Hospital,,1.0,,Drug logistics,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,OTHER,,,,,,,2021,0.0
NCT04619706,,2020-11-05,,2022-08-22,2022-11-29,2020-11-05,2020-11-06,ACTUAL,,,,2022-08-22,2022-08-24,ACTUAL,2022-11-29,2022-12-05,ACTUAL,2020-12-14,ACTUAL,2020-12-14,2022-11,2022-11-30,2021-08-24,ACTUAL,2021-08-24,2021-08-24,ACTUAL,2021-08-24,,INTERVENTIONAL,,,Ultramicronized Palmitoylethanolamide (PEA) Treatment in Hospitalized Participants With COVID-19,"A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIA Study of FSD201 (Ultramicronized PEA) + Standard of Care (SOC) Vs SOC in the Treatment of Hospitalized Patients With COVID-19",TERMINATED,,PHASE2,53.0,ACTUAL,Quantum Biopharma,,3.0,,Difficulties recruiting new subjects,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,INDUSTRY,,,,,,,2021,0.0
NCT03768115,,2018-12-03,,,2020-10-20,2018-12-05,2018-12-07,ACTUAL,,,,,,,2020-10-20,2020-10-22,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2020-10,2020-10-31,2020-10-14,ACTUAL,2020-10-14,2020-10-14,ACTUAL,2020-10-14,,INTERVENTIONAL,,,Autologous Plasma Treatment for Severe Dry Eye Patients,Use of Autologous Plasma Eyedrops Therapy for Severe Dry Eye in Singapore,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Singapore National Eye Centre,,,,The inclusion criteria for plasmapheresis is too stringent to get any potential subjects.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,OTHER_GOV,,,,,,,2020,0.0
NCT03214250,,2017-06-09,2022-03-25,,2022-12-21,2017-07-10,2017-07-11,ACTUAL,2022-08-10,2022-08-11,ACTUAL,,,,2022-12-21,2022-12-23,ACTUAL,2017-07-21,ACTUAL,2017-07-21,2022-12,2022-12-31,2022-02-25,ACTUAL,2022-02-25,2021-02-11,ACTUAL,2021-02-11,,INTERVENTIONAL,,The Phase 1b Safety Population is defined as all patients who were enrolled in Phase 1b and who received at least 1 dose of any study drug. The Phase 2 Efficacy Population is defined as all patients who were randomized in Phase 2 and who received at least 1 dose of any study drug.,Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma,"Open-label, Multicenter, Phase 1b/2 Clinical Study to Evaluate the Safety and Efficacy of CD40 Agonistic Monoclonal Antibody (APX005M) Administered Together With Gemcitabine and Nab-Paclitaxel With or Without PD-1 Blocking Antibody (Nivolumab) in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma",COMPLETED,,PHASE1/PHASE2,129.0,ACTUAL,Parker Institute for Cancer Immunotherapy,,3.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,OTHER,,,,,,,2022,1.0
NCT04120064,,2019-09-06,,,2021-01-27,2019-10-04,2019-10-09,ACTUAL,,,,,,,2021-01-27,2021-02-01,ACTUAL,2019-01-25,ACTUAL,2019-01-25,2021-01,2021-01-31,2021-01-15,ACTUAL,2021-01-15,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol,Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol in the Outpatient Setting,TERMINATED,,PHASE1,60.0,ACTUAL,Parkview Medical Center,,2.0,,"Covid19, not able to finish recruitment",f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,OTHER,,,,,,,2021,0.0
NCT05205252,,2021-12-29,,,2023-08-11,2022-01-14,2022-01-25,ACTUAL,,,,,,,2023-08-11,2023-08-15,ACTUAL,2021-12-22,ACTUAL,2021-12-22,2023-08,2023-08-31,2023-07-05,ACTUAL,2023-07-05,2023-07-05,ACTUAL,2023-07-05,,INTERVENTIONAL,ARIA,,A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.,"ARIA: A Phase 1b/2, Open-label, Multi Cohort Trial of Tazemetostat in Combination With Various Treatments in Subjects With Relapsed or Refractory Hematologic Malignancies",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Ipsen,,5.0,,Epizyme Inc. has revised the Tazemetostat development strategy and made the decision to terminate the hematological malignancies basket trial.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,INDUSTRY,,,,,,,2023,0.0
NCT04292730,,2020-02-28,2020-12-15,,2021-01-21,2020-02-28,2020-03-03,ACTUAL,2021-01-21,2021-01-26,ACTUAL,,,,2021-01-21,2021-01-26,ACTUAL,2020-03-15,ACTUAL,2020-03-15,2021-01,2021-01-31,2020-06-26,ACTUAL,2020-06-26,2020-04-29,ACTUAL,2020-04-29,,INTERVENTIONAL,,Part A: Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group).~Part B: Expanded RDV-Treated Analysis Set included participants who were enrolled into Part B of the study and received at least 1 dose of study drug.,Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment,A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate COVID-19 Compared to Standard of Care Treatment,COMPLETED,,PHASE3,1113.0,ACTUAL,Gilead Sciences,,4.0,,,t,,,,t,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.",2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,INDUSTRY,,NCT04323761,APPROVED_FOR_MARKETING,,,,2020,1.0
NCT03995212,,2019-06-19,,2023-06-28,2023-06-28,2019-06-19,2019-06-21,ACTUAL,,,,,2023-07-03,ACTUAL,2023-06-28,2023-07-03,ACTUAL,2019-06-25,ACTUAL,2019-06-25,2023-06,2023-06-30,2022-06-29,ACTUAL,2022-06-29,2022-06-29,ACTUAL,2022-06-29,,INTERVENTIONAL,,,Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus,"A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral CR845 in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus",TERMINATED,,PHASE2,14.0,ACTUAL,"Cara Therapeutics, Inc.",,2.0,,Slow enrollment due primarily to Covid-19,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,INDUSTRY,,,,,,,2022,0.0
NCT02983006,,2016-12-02,,,2021-10-08,2016-12-02,2016-12-06,ESTIMATED,,,,,,,2021-10-08,2021-10-18,ACTUAL,2016-10,ACTUAL,2016-10-31,2021-10,2021-10-31,2021-01-01,ACTUAL,2021-01-01,2019-12-23,ACTUAL,2019-12-23,,INTERVENTIONAL,,,Study of DS-8273a With Nivolumab in Unresectable Stage III or Stage IV Melanoma,A Phase 1 Study of TRAIL-DR5 Antibody DS-8273a Administered in Combination With Nivolumab in Subjects With Unresectable Stage III or Stage IV Melanoma,COMPLETED,,PHASE1,12.0,ACTUAL,NYU Langone Health,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,OTHER,,,,,,,2021,1.0
NCT04443881,,2020-06-18,,,2021-05-27,2020-06-20,2020-06-23,ACTUAL,,,,,,,2021-05-27,2021-06-01,ACTUAL,2020-05-08,ACTUAL,2020-05-08,2021-05,2021-05-31,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,ANA-COVID-GEAS,,Clinical Trial of the Use of Anakinra in Cytokine Storm Syndrome Secondary to Covid-19 (ANA-COVID-GEAS),"Clinical Trial of the Use of Anakinra in Cytokine Storm Syndrome Secondary to Covid-19. A Phase 2/3, Randomized, Open-label, Parallel Group, 2-arm, Multicenter Study Investigating the Efficacy and Safety of Intravenous Administrations of Anakinra, an Interleukin-1(IL-1) Receptor Antagonist, Added to Standard of Care, Versus Standard of Care, in Reducing Hyper-inflammation and Respiratory Distress in Patients With SARS- CoV-2 Infection",COMPLETED,,PHASE2/PHASE3,179.0,ACTUAL,Fundacion Miguel Servet,,2.0,,,f,,,,f,f,f,,,f,,,,,,NO,"All collected IPD will be available for exploitation in future research projects. This statement also includes the availability of the study protocol, the statistical analysis plan, the informed consent form, the clinical study report and the analytic code.",2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,OTHER,,,,,,,2021,0.0
NCT02508636,,2015-07-23,2021-08-03,,2021-09-14,2015-07-24,2015-07-27,ESTIMATED,2021-09-14,2021-10-12,ACTUAL,,,,2021-09-14,2021-10-12,ACTUAL,2015-12-22,ACTUAL,2015-12-22,2021-08,2021-08-31,2020-08-31,ACTUAL,2020-08-31,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,,,Trial of Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate Cancer,Phase II Trial of Definitive Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate Cancer,TERMINATED,,PHASE2,11.0,ACTUAL,"University of California, San Francisco",The study closed earlier than expected which resulted in a low accrual,1.0,,Low Accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,OTHER,,,,,,,2020,0.0
NCT04297839,,2019-10-28,,,2021-09-27,2020-03-05,2020-03-06,ACTUAL,,,,,,,2021-09-27,2021-10-05,ACTUAL,2019-02-12,ACTUAL,2019-02-12,2021-09,2021-09-30,2022-07-31,ESTIMATED,2022-07-31,2022-07-31,ESTIMATED,2022-07-31,,INTERVENTIONAL,,,Evaluation of Regional Anticoagulation With Citrate in Extended Hemodialysis,Evaluation of the Efficacy and Safety of Regional Anticoagulation With Citrate in Extended Hemodialysis in Patients With Acute Renal Injury Admitted to an Intensive Care Unit,SUSPENDED,,PHASE3,200.0,ESTIMATED,University of Sao Paulo General Hospital,,2.0,,"DUE TO CORONAVIRUS DISEASE, ACTIVITIES INTHE HOSPITAL ARE SUPRESSED",f,,,,t,t,f,,,t,,,,,,UNDECIDED,The researchers have hot decided yet about this issue,2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,OTHER,,,,,,,2022,0.0
NCT04472637,,2020-07-11,,,2022-04-13,2020-07-11,2020-07-15,ACTUAL,,,,,,,2022-04-13,2022-04-15,ACTUAL,2020-11-01,ACTUAL,2020-11-01,2022-04,2022-04-30,2021-07-01,ACTUAL,2021-07-01,2021-05-01,ACTUAL,2021-05-01,,INTERVENTIONAL,,,Atorvastatin Effects On Arterial Stiffness In Hemodialysis,Atorvastatin Effects On Arterial Stiffness In Hemodialysis Patients,COMPLETED,,PHASE2,50.0,ACTUAL,Alexandria University,,2.0,,,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,OTHER,,,,,,,2021,1.0
NCT02540954,,2015-09-02,2020-12-21,,2021-06-01,2015-09-02,2015-09-04,ESTIMATED,2021-03-16,2021-04-08,ACTUAL,,,,2021-06-01,2021-06-11,ACTUAL,2015-09-29,ACTUAL,2015-09-29,2021-06,2021-06-30,2020-06-04,ACTUAL,2020-06-04,2019-12-24,ACTUAL,2019-12-24,,INTERVENTIONAL,,Safety analysis set (SAF): included all participants who received any study drug,Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD),"An Open-label, Randomized, Active-controlled, Parallel-group, Phase-3b Study of the Efficacy, Safety, and Tolerability of 2 mg Aflibercept Administered by Intravitreal Injections Using Two Different Treatment Regimens to Subjects With Neovascular Age-related Macular Degeneration (nAMD).",COMPLETED,,PHASE3,336.0,ACTUAL,Bayer,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,INDUSTRY,,,,,,,2020,1.0
NCT04750577,,2021-02-09,2024-05-29,2023-11-17,2024-07-02,2021-02-09,2021-02-11,ACTUAL,2024-07-02,2024-07-23,ACTUAL,,2024-07-23,ACTUAL,2024-07-02,2024-07-23,ACTUAL,2021-04-27,ACTUAL,2021-04-27,2024-07,2024-07-31,2022-12-27,ACTUAL,2022-12-27,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,,Randomised Set (RS): This patient set includes all entered and randomised patients.,A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease,"Randomised, Double-blind (Within Dose Groups), Placebo-controlled and Parallel Group Trial to Investigate the Effects of Different Doses of Oral BI 685509 Given Over 20 Weeks on UACR Reduction in Patients With Diabetic Kidney Disease",COMPLETED,,PHASE2,243.0,ACTUAL,Boehringer Ingelheim,,4.0,,,f,,,,f,t,f,,,,,,"One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.",https://www.mystudywindow.com/msw/datasharing,YES,"Once the criteria in section Time Frame are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.",2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,INDUSTRY,,,,,,,2022,1.0
NCT04409288,,2020-05-27,,,2024-01-03,2020-05-27,2020-06-01,ACTUAL,,,,,,,2024-01-03,2024-01-05,ACTUAL,2020-07-20,ACTUAL,2020-07-20,2024-01,2024-01-31,2023-10-16,ACTUAL,2023-10-16,2023-10-16,ACTUAL,2023-10-16,,INTERVENTIONAL,,,Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer,"Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer: An Open-label, Randomized, Cross-Over Trial.",TERMINATED,,PHASE3,74.0,ACTUAL,Chinese University of Hong Kong,,2.0,,Endpoint reached,f,,,,,t,f,,,t,,,,,,NO,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,OTHER,,,,,,,2023,0.0
NCT04406194,,2020-05-24,2020-06-10,,2020-08-13,2020-05-27,2020-05-28,ACTUAL,2020-08-06,2020-08-12,ACTUAL,,,,2020-08-13,2020-08-14,ACTUAL,2020-05-14,ACTUAL,2020-05-14,2020-08,2020-08-31,2020-06-19,ACTUAL,2020-06-19,2020-05-22,ACTUAL,2020-05-22,,INTERVENTIONAL,Favipiravir,,"Bioequivalence Study of Favipiravir 200 mg Film Tablet (ATABAY, Turkey) Under Fasting Conditions","Open-label,Randomised,Single Oral Dose,Two-period,Cross-over Trial to Assess to Bioequivalence of Favicovir 200 mg FT in Comparison With Avigan 200 mg FT in Healthy Male Subjects Under Fasting Conditions",COMPLETED,,PHASE1,30.0,ACTUAL,Atabay Kimya Sanayi Ticaret A.S.,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,INDUSTRY,,,,,,,2020,1.0
NCT03257215,,2017-08-13,,,2024-09-25,2017-08-17,2017-08-22,ACTUAL,,,,,,,2024-09-25,2024-09-27,ACTUAL,2017-10-16,ACTUAL,2017-10-16,2024-09,2024-09-30,2024-12,ESTIMATED,2024-12-31,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,D-Vex,,Can Vitamin D Treatment Help Treat Moderate to Severe Atopic Dermatitis in Young Children? the D-Vex Pilot Study,"A Phase IV, Double-blind, Randomised, Placebo-controlled Trial to Assess the Efficacy and Safety of Stoss Versus Daily Dose Oral Vitamin D Compared to Placebo for the Treatment of Atopic Dermatitis in Pre-school Aged Children- a Pilot Study",SUSPENDED,,PHASE4,50.0,ESTIMATED,Murdoch Childrens Research Institute,,3.0,,Recruitment very slow \& funding difficult - exacerbated by COVID-19 pandemic,f,,,,f,f,f,,,f,,,,,,,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,OTHER,,,,,,,2024,0.0
NCT03876028,,2019-03-13,,,2023-01-27,2019-03-13,2019-03-15,ACTUAL,,,,,,,2023-01-27,2023-01-31,ACTUAL,2019-06-11,ACTUAL,2019-06-11,2023-01,2023-01-31,2021-11-01,ACTUAL,2021-11-01,2021-11-01,ACTUAL,2021-11-01,,INTERVENTIONAL,,,Study of Tisagenlecleucel in Combination With Ibrutinib in r/r Diffuse Large B-cell Lymphoma Patients,"A Phase Ib, Multicenter Study to Determine the Safety and Tolerability of Tisagenlecleucel in Combination With Ibrutinib in Adult Patients With Relapsed and/or Refractory Diffuse Large B-cell Lymphoma",TERMINATED,,PHASE1,10.0,ACTUAL,Novartis,,2.0,,Business reasons,f,,,,f,t,f,,,,,,,,,,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,INDUSTRY,,,,,,,2021,0.0
NCT04775173,,2021-02-19,,,2024-05-05,2021-02-25,2021-03-01,ACTUAL,,,,,,,2024-05-05,2024-05-07,ACTUAL,2021-02-17,ACTUAL,2021-02-17,2024-05,2024-05-31,2023-08-10,ACTUAL,2023-08-10,2023-08-10,ACTUAL,2023-08-10,,INTERVENTIONAL,,,Efficacy and Safety of Different Concentrations of Sirolimus in the Treatment of Kaposiform Hemangioendothelioma.,Efficacy and Safety of High- vs Low-Dose Sirolimus in Patients With Kaposiform Hemangioendothelioma: A Trial Protocol,COMPLETED,,PHASE2,79.0,ACTUAL,West China Hospital,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,OTHER,,,,,,,2023,1.0
NCT04795583,,2021-03-10,,,2022-04-06,2021-03-11,2021-03-12,ACTUAL,,,,,,,2022-04-06,2022-04-14,ACTUAL,2021-08-01,ESTIMATED,2021-08-01,2021-06,2021-06-30,2022-08,ESTIMATED,2022-08-31,2022-04,ESTIMATED,2022-04-30,,INTERVENTIONAL,CORE-COVID,,Corticosteroids for COVID-19,A Randomized Clinical Trial Comparing 7 Days Treatment With Corticosteroids Versus Placebo for Early COVID-19,WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Alberta,,2.0,,Funding Issues,f,,,,t,t,t,,,t,,,,,,,,2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,OTHER,,,,,,,2022,0.0
NCT03761134,,2018-11-29,,,2022-04-21,2018-11-29,2018-12-03,ACTUAL,,,,,,,2022-04-21,2022-04-25,ACTUAL,2018-11-30,ACTUAL,2018-11-30,2022-04,2022-04-30,2020-04-29,ACTUAL,2020-04-29,2020-04-29,ACTUAL,2020-04-29,,INTERVENTIONAL,,,Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea,"A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Chinese Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone or Metformin in Combination With Sulfonylurea",TERMINATED,,PHASE3,377.0,ACTUAL,Sanofi,,3.0,,Sanofi ended collaboration with Lexicon for Sotagliflozin. In China no regulatory pathway to transfer sponsorship during the conduct of ongoing studies.,f,,,,f,f,f,,,f,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,INDUSTRY,,,,,,,2020,0.0
NCT04590495,,2020-10-09,2022-07-20,,2022-08-21,2020-10-09,2020-10-19,ACTUAL,2022-08-21,2022-09-15,ACTUAL,,,,2022-08-21,2022-09-15,ACTUAL,2021-04-01,ACTUAL,2021-04-01,2022-08,2022-08-31,2021-12-01,ACTUAL,2021-12-01,2021-12-01,ACTUAL,2021-12-01,,INTERVENTIONAL,,,The Effects of Cannabidiol on the Driving Ability of Healthy Adults,The Effects of Cannabidiol on the Driving Ability of Healthy Adults: a Clinical Trial,COMPLETED,,PHASE2,40.0,ACTUAL,West Virginia University,"Only one dosage of CBD was utilized, and this dose may not reflect normal use of CBD. Participants were recruited from a university so results may not be generalizable to the general population. Previous studies have shown that CBD's max absorption occurs 2-5 hours post-consumption. To balance participant burden, a two-hour waiting period between dosing and simulation was chosen. It is possible that max absorption and full effect of the drug was not reached amongst some participants.",2.0,,,f,,,,,t,f,,,f,,,,,,NO,We do not plan to share these data.,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,OTHER,,,,,,,2021,1.0
NCT04231331,,2020-01-14,,,2023-11-18,2020-01-14,2020-01-18,ACTUAL,,,,,,,2023-11-18,2023-11-21,ACTUAL,2020-11-04,ACTUAL,2020-11-04,2023-11,2023-11-30,2023-11-15,ACTUAL,2023-11-15,2023-11-15,ACTUAL,2023-11-15,,INTERVENTIONAL,EFFORT,,Ertugliflozin for Functional Mitral Regurgitation,"Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy of Ertugliflozin on Reduction of Mitral Regurgitation in Patients With Functional Mitral Regurgitation Secondary to Left Ventricular Dysfunction",COMPLETED,,PHASE3,128.0,ACTUAL,Asan Medical Center,,2.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,OTHER,,,,,,,2023,1.0
NCT03689894,,2018-09-27,2022-09-16,,2023-11-03,2018-09-27,2018-10-01,ACTUAL,2023-11-03,2023-11-28,ACTUAL,,,,2023-11-03,2023-11-28,ACTUAL,2019-04-11,ACTUAL,2019-04-11,2023-11,2023-11-30,2021-09-20,ACTUAL,2021-09-20,2021-09-20,ACTUAL,2021-09-20,,INTERVENTIONAL,,,Ibrutinib Plus Rituximab for cGVHD Following Allo-SCT,Combination Ibrutinib and Rituximab for the Treatment of Chronic Graft-Versus-Host Disease Following Allogeneic Stem Cell Transplant,TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,Dartmouth-Hitchcock Medical Center,,1.0,,Insufficient accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,OTHER,,,,,,,2021,0.0
NCT04212377,,2019-11-20,,,2024-01-09,2019-12-23,2019-12-27,ACTUAL,,,,,,,2024-01-09,2024-01-11,ACTUAL,2019-04-08,ACTUAL,2019-04-08,2020-12,2020-12-31,2021-03-09,ACTUAL,2021-03-09,2021-03-09,ACTUAL,2021-03-09,,INTERVENTIONAL,DECENDO,,Dendritic Cells for Immunotherapy of Metastatic Endometrial Cancer Patients,An Exploratory Study: Dendritic Cells for Immunotherapy of Metastatic Endometrial Cancer Patients,COMPLETED,,PHASE2,8.0,ACTUAL,Radboud University Medical Center,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,OTHER,,,,,,,2021,1.0
NCT03886649,,2019-03-21,,,2022-03-18,2019-03-21,2019-03-22,ACTUAL,,,,,,,2022-03-18,2022-04-01,ACTUAL,2019-11-04,ACTUAL,2019-11-04,2022-03,2022-03-31,2022-03-08,ACTUAL,2022-03-08,2021-05-10,ACTUAL,2021-05-10,,INTERVENTIONAL,,,Copanlisib in Combination With Venetoclax in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.,Copanlisib in Combination With Venetoclax in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma. A Multicenter Phase Ib Trial With Two Expansion Cohorts,TERMINATED,,PHASE1,7.0,ACTUAL,Swiss Group for Clinical Cancer Research,,1.0,,Insufficient Funding,f,,,,t,f,f,,,,,,,,,,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,OTHER,,,,,,,2022,0.0
NCT01848639,,2013-05-03,,,2023-10-05,2013-05-03,2013-05-07,ESTIMATED,,,,,,,2023-10-05,2023-10-10,ACTUAL,2013-06,ACTUAL,2013-06-30,2023-10,2023-10-31,2022-11,ACTUAL,2022-11-30,2022-11,ACTUAL,2022-11-30,,INTERVENTIONAL,ALCHEMIST,,ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial,"ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial (ALCHEMIST), Phase III b",COMPLETED,,PHASE3,823.0,ACTUAL,"University Hospital, Brest",,2.0,,,f,,,,t,,,,,,,,,,https://cic-p-nancy.fr/wp-content/uploads/2023/10/Alchemist_SAP-V3-and-SAP-QoL-V08-20231005-signe.pdf,YES,Statistical Analysis Plan,2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,OTHER,,,,,,,2022,1.0
NCT05545319,,2022-09-16,,,2023-02-27,2022-09-16,2022-09-19,ACTUAL,,,,,,,2023-02-27,2023-03-01,ACTUAL,2022-12-13,ESTIMATED,2022-12-13,2023-02,2023-02-28,2024-01-06,ESTIMATED,2024-01-06,2023-09-21,ESTIMATED,2023-09-21,,INTERVENTIONAL,EPIC-HOS,,A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People With Weakened Immune Systems or at Increased Risk for Poor Outcomes Who Are Hospitalized Due to Severe COVID-19,"AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED NIRMATRELVIR/RITONAVIR COMPARED WITH PLACEBO/RITONAVIR FOR THE TREATMENT OF SEVERE COVID-19 IN HOSPITALIZED PARTICIPANTS WHO ARE IMMUNOCOMPROMISED OR AT INCREASED RISK FOR SEVERE COVID-19 OUTCOMES",WITHDRAWN,,PHASE2,0.0,ACTUAL,Pfizer,,2.0,,"Termination due to challenges related to the operational feasibility of the study, taking into account the current epidemiology and declining hospitalization rates for severe COVID-19.",f,,,,t,t,f,,,t,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,INDUSTRY,,,,,,,2024,0.0
NCT05250583,,2022-02-10,,,2022-06-23,2022-02-10,2022-02-22,ACTUAL,,,,,,,2022-06-23,2022-06-29,ACTUAL,2020-06-29,ACTUAL,2020-06-29,2022-06,2022-06-30,2021-01-07,ACTUAL,2021-01-07,2021-01-07,ACTUAL,2021-01-07,,INTERVENTIONAL,,,Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Treatment-Resistant Keratitis,"Use of a Double Amniotic Membrane Inserted in a Ring of Umbilical Vessels With Wharton's Jelly, Tissues Treated by the AMTRIX Process, in the Treatment of Keratitis Resisting Healing Medical Treatment",TERMINATED,,PHASE2,5.0,ACTUAL,TBF Genie Tissulaire,,1.0,,Low accrual rate,f,,,,f,f,f,,,,,,,,,,,2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,INDUSTRY,,,,,,,2021,0.0
NCT04156828,,2019-11-04,,,2023-06-27,2019-11-05,2019-11-08,ACTUAL,,,,,,,2023-06-27,2023-06-29,ACTUAL,2020-03-31,ACTUAL,2020-03-31,2023-06,2023-06-30,2023-06-08,ACTUAL,2023-06-08,2022-04-27,ACTUAL,2022-04-27,,INTERVENTIONAL,,,Copanlisib and Combination Chemotherapy for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Relapsed Grade 3b Follicular Lymphoma,"A Phase I Study Evaluating Copanlisib in Combination With R-GCD (Gemcitabine, Carboplatin, Dexamethasone, and Rituximab) With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and High-Risk Follicular Lymphoma",TERMINATED,,PHASE1,12.0,ACTUAL,University of Washington,,1.0,,Terminated due to low accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:18:50.500901,2024-10-16 08:18:50.500901,OTHER,,,,,,,2023,0.0
NCT04657497,,2020-11-09,,,2024-04-04,2020-12-06,2020-12-08,ACTUAL,,,,,,,2024-04-04,2024-04-05,ACTUAL,2020-11-09,ACTUAL,2020-11-09,2024-04,2024-04-30,2021-04-09,ACTUAL,2021-04-09,2021-03-26,ACTUAL,2021-03-26,,INTERVENTIONAL,,,A Study of FOY-305 in Patients With SARS-Cov-2 Infection (COVID-19),"A Placebo-controlled, Multicenter, Double-blind, Randomized, Parallel-group Comparative Study in SARS-CoV-2 Infection (COVID-19)",COMPLETED,,PHASE3,155.0,ACTUAL,Ono Pharmaceutical Co. Ltd,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,INDUSTRY,,,,,,,2021,0.0
NCT05510245,,2022-08-19,,,2023-12-12,2022-08-19,2022-08-22,ACTUAL,,,,,,,2023-12-12,2023-12-18,ACTUAL,2022-08-29,ACTUAL,2022-08-29,2023-12,2023-12-31,2023-07-20,ACTUAL,2023-07-20,2023-07-20,ACTUAL,2023-07-20,,INTERVENTIONAL,,,A Clinical Trial of the Study Medicine (PF-07081532) in People With Diabetes and Kidney Dysfunction,"A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE PHARMACOKINETICS OF PF-07081532 IN ADULT PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT RENAL IMPAIRMENT",TERMINATED,,PHASE1,18.0,ACTUAL,Pfizer,,4.0,,The decision to terminate clinical development of lotiglipron is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,INDUSTRY,,,,,,,2023,0.0
NCT05321862,,2022-03-24,,,2023-11-13,2022-04-04,2022-04-11,ACTUAL,,,,,,,2023-11-13,2023-11-15,ACTUAL,2023-03-14,ACTUAL,2023-03-14,2023-11,2023-11-30,2023-05-04,ACTUAL,2023-05-04,2023-05-04,ACTUAL,2023-05-04,,INTERVENTIONAL,PENTI-MIDAS,,Relevance Evaluation of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients.,Exploratory Study Evaluating the Relevance of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation Less Than 66 Years Included in the Prospective IFM 2020-02.,WITHDRAWN,,PHASE2,0.0,ACTUAL,Nantes University Hospital,,1.0,,MIDAS inclusions terminated before first inclusion in PENTI-MIDAS,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,OTHER,,,,,,,2023,0.0
NCT03808168,,2019-01-15,,,2019-01-17,2019-01-15,2019-01-17,ACTUAL,,,,,,,2019-01-17,2019-01-18,ACTUAL,2019-01-15,ESTIMATED,2019-01-15,2019-01,2019-01-31,2020-06-01,ESTIMATED,2020-06-01,2019-06-01,ESTIMATED,2019-06-01,,INTERVENTIONAL,,,Nivolumab Based Immunotherapy for Treatment of High Grade Cervical Dysplasia,Phase II Trial of Nivolumab Based Immunotherapy for the Treatment of High-Grade Cervical Dysplasia,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,FDA has withdrawn the IND application- requesting protocol changes,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,OTHER,,,,,,,2020,0.0
NCT05074433,,2021-10-08,2023-05-16,,2023-06-28,2021-10-08,2021-10-12,ACTUAL,2023-06-28,2023-07-24,ACTUAL,,,,2023-06-28,2023-07-24,ACTUAL,2021-10-25,ACTUAL,2021-10-25,2023-06,2023-06-30,2022-05-18,ACTUAL,2022-05-18,2022-05-18,ACTUAL,2022-05-18,,INTERVENTIONAL,,,A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies as Pre-Exposure Prophylaxis to Prevent COVID-19 in Immunocompromised Participants",TERMINATED,,PHASE3,66.0,ACTUAL,Regeneron Pharmaceuticals,,4.0,,Emerging SARS-CoV2 variants impacting susceptibility to study drug,t,,,,t,t,f,,,,,,"When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.",Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf,https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,INDUSTRY,,NCT04617535,NO_LONGER_AVAILABLE,,,,2022,0.0
NCT03925324,,2019-04-01,2022-01-03,,2022-01-03,2019-04-19,2019-04-24,ACTUAL,2022-01-03,2022-02-02,ACTUAL,,,,2022-01-03,2022-02-02,ACTUAL,2019-05-03,ACTUAL,2019-05-03,2022-01,2022-01-31,2021-08-16,ACTUAL,2021-08-16,2021-08-16,ACTUAL,2021-08-16,,INTERVENTIONAL,STEM-VAD,,Serial Infusions of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients With Left Ventricular Assist Device,"A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of the Safety and Efficacy of Intravenous Delivery of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients and Implanted Left Ventricular Assist Device",TERMINATED,,PHASE2,4.0,ACTUAL,Medstar Health Research Institute,"Due to lack of funding and COVID-19, the study was terminated early after 4 patients were recruited. This number is too small to perform any analysis",2.0,,Lack of funding/Covid-19,f,,,,t,t,f,,,,,,,,,,,2024-10-15 11:21:12.837849,2024-10-15 11:21:12.837849,OTHER,,,,,,,2021,0.0
NCT03699033,,2018-10-03,,,2020-11-03,2018-10-04,2018-10-09,ACTUAL,,,,,,,2020-11-03,2020-11-05,ACTUAL,2018-10-01,ACTUAL,2018-10-01,2018-10,2018-10-31,2020-10-01,ACTUAL,2020-10-01,2020-10-01,ACTUAL,2020-10-01,,INTERVENTIONAL,,,Hypofractionated Radiotherapy With Carboplatin and Paclitaxel in Non-Small Cell Lung Cancer,A Phase II Trial of Hypofractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction to PET-avid Disease Combined With Carboplatin and Paclitaxel for Subjects With Stage IIIA or IIIB Non-Small Cell Lung Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Toledo,,1.0,,No patients available,f,,,,f,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,OTHER,,,,,,,2020,0.0
NCT05017610,,2021-07-28,,,2022-11-30,2021-08-17,2021-08-24,ACTUAL,,,,,,,2022-11-30,2022-12-02,ACTUAL,2021-10-20,ACTUAL,2021-10-20,2022-11,2022-11-30,2022-10-14,ACTUAL,2022-10-14,2022-10-14,ACTUAL,2022-10-14,,INTERVENTIONAL,,,Inducing a Hypothyroxinemic State in Patients With Recurrent Glioblastoma or Gliosarcoma,A Single Arm Pilot Study to Evaluate the Safety and Feasibility of Inducing a Hypothyroxinemic State in Patients With Recurrent Glioblastoma,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Emory University,,1.0,,Per the PI-slow accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,OTHER,,,,,,,2022,0.0
NCT01121588,,2010-05-10,,,2023-11-07,2010-05-10,2010-05-12,ESTIMATED,,,,,,,2023-11-07,2023-11-09,ACTUAL,2011-03-22,ACTUAL,2011-03-22,2023-11,2023-11-30,2023-09-07,ACTUAL,2023-09-07,2023-09-07,ACTUAL,2023-09-07,,INTERVENTIONAL,,,"An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)",PHASE 1B OPEN-LABEL STUDY OF THE SAFETY AND CLINICAL ACTIVITY OF CRIZOTINIB (PF-02341066) IN TUMORS WITH GENETIC EVENTS INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK ) GENE LOCUS,TERMINATED,,PHASE1,44.0,ACTUAL,Pfizer,,1.0,,Termination of further treatment on the study due to the availability of commercial supply or a rollover study (NCT05160922) that will allow active subjects to continue receiving treatment.,f,,,,f,,,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,INDUSTRY,,,,,,,2023,0.0
NCT03488251,,2018-03-12,2022-06-01,,2022-07-18,2018-03-28,2018-04-04,ACTUAL,2022-07-18,2022-08-16,ACTUAL,,,,2022-07-18,2022-08-16,ACTUAL,2018-08-20,ACTUAL,2018-08-20,2022-07,2022-07-31,2021-03-12,ACTUAL,2021-03-12,2021-03-12,ACTUAL,2021-03-12,,INTERVENTIONAL,,Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.,"PK,PD,Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Gemcitabine and Oxaliplatin for the Treatment of Patients With Relapsed/Refractory Diffuse Large B Cell Non-Hodgkin's Lymphoma","Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Gemcitabine and Oxaliplatin for the Treatment of Subjects With Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma",TERMINATED,,PHASE2,8.0,ACTUAL,"Molecular Templates, Inc.",,4.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,INDUSTRY,,,,,,,2021,0.0
NCT02864147,,2016-08-04,2024-01-11,,2024-04-05,2016-08-08,2016-08-11,ESTIMATED,2024-04-05,2024-05-02,ACTUAL,,,,2024-04-05,2024-05-02,ACTUAL,2016-07,,2016-07-31,2024-04,2024-04-30,2022-11-22,ACTUAL,2022-11-22,2022-05-24,ACTUAL,2022-05-24,,INTERVENTIONAL,,,Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3),Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3) Using a Novel Prime and Pull Strategy,COMPLETED,,PHASE2,134.0,ACTUAL,Yale University,,3.0,,,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,OTHER,,,,,,,2022,1.0
NCT04111107,,2019-09-27,2024-05-20,,2024-06-11,2019-09-30,2019-10-01,ACTUAL,2024-06-11,2024-07-03,ACTUAL,,,,2024-06-11,2024-07-03,ACTUAL,2020-04-22,ACTUAL,2020-04-22,2024-06,2024-06-30,2023-02-09,ACTUAL,2023-02-09,2022-12-09,ACTUAL,2022-12-09,,INTERVENTIONAL,,,Precision Medicine for Patients With Identified Actionable Mutations,Precision Medicine for Patients With Identified Actionable Mutations at Wake Forest Baptist Comprehensive Cancer Center (WFBCCC): A Pragmatic Trial-,TERMINATED,,PHASE2,45.0,ACTUAL,Wake Forest University Health Sciences,,1.0,,PI left the institution and site decided not to continue the study,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,OTHER,,,,,,,2023,0.0
NCT03275402,,2017-09-06,2023-12-18,,2024-01-22,2017-09-06,2017-09-07,ACTUAL,2024-01-22,2024-02-13,ACTUAL,,,,2024-01-22,2024-02-13,ACTUAL,2018-12-11,ACTUAL,2018-12-11,2024-01,2024-01-31,2023-06-02,ACTUAL,2023-06-02,2023-06-02,ACTUAL,2023-06-02,,INTERVENTIONAL,,,131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases,A Multicenter Phase 2/3 Trial of the Efficacy and Safety of Intracerebroventricular Radioimmunotherapy Using 131I-omburtamab for Neuroblastoma Central Nervous System/Leptomeningeal Metastases,TERMINATED,,PHASE2/PHASE3,52.0,ACTUAL,Y-mAbs Therapeutics,The trial was terminated early due to a business strategy decision.,1.0,,Corporate business decision. Not due to safety or efficacy concerns.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,INDUSTRY,,,,,,,2023,0.0
NCT03381196,,2017-12-18,2021-04-30,,2021-04-30,2017-12-18,2017-12-21,ACTUAL,2021-04-30,2021-05-24,ACTUAL,,,,2021-04-30,2021-05-24,ACTUAL,2018-01-21,ACTUAL,2018-01-21,2021-04,2021-04-30,2020-08-24,ACTUAL,2020-08-24,2020-05-28,ACTUAL,2020-05-28,,INTERVENTIONAL,,The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.,"A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications","A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection Who Are at Risk of Developing Complications",TERMINATED,,PHASE3,553.0,ACTUAL,"Janssen Research & Development, LLC","As the study was terminated early after a pre-planned interim analysis which showed futility, the Sponsor decided not to perform the complete analysis planned per protocol. Hence, data was collected and analyzed for safety and selected efficacy parameters.",2.0,,Based on interim Analysis outcome being futile for FLZ3001; decision was taken to stop (early terminate) both FLZ3001/3002. There was no safety concern.,t,,,,t,t,f,,,,,,,,,,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,INDUSTRY,,NCT03834376,NO_LONGER_AVAILABLE,,,,2020,0.0
NCT04197986,,2019-12-02,2023-12-20,,2024-02-16,2019-12-12,2019-12-13,ACTUAL,2024-02-16,2024-03-13,ACTUAL,,,,2024-02-16,2024-03-13,ACTUAL,2020-03-11,ACTUAL,2020-03-11,2024-02,2024-02-29,2023-02-28,ACTUAL,2023-02-28,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,PROOF302,,Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations,"Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations (PROOF 302)",TERMINATED,,PHASE3,39.0,ACTUAL,"QED Therapeutics, Inc.",,2.0,,The sponsor has decided to close the study due to the discontinuation of infigratinib development. The discontinuation of the study was not due to safety reasons.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,INDUSTRY,,,,,,,2023,0.0
NCT04853524,,2021-04-20,,,2021-07-12,2021-04-20,2021-04-21,ACTUAL,,,,,,,2021-07-12,2021-07-15,ACTUAL,2021-05-06,ACTUAL,2021-05-06,2021-07,2021-07-31,2021-07-30,ESTIMATED,2021-07-30,2021-06-15,ESTIMATED,2021-06-15,,INTERVENTIONAL,,,A Study of JNJ-56136379 in Healthy Participants,"A Phase 1, Open-label Study in Healthy Participants to Investigate the Effect of Multiple-dose JNJ-56136379 on the Single-dose Pharmacokinetics of Bictegravir, Emtricitabine, and Tenofovir Alafenamide",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Janssen Research & Development, LLC",,1.0,,Sponsor Decision,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,INDUSTRY,,,,,,,2021,0.0
NCT04316624,,2020-03-15,,,2023-07-17,2020-03-18,2020-03-20,ACTUAL,,,,,,,2023-07-17,2023-07-19,ACTUAL,2019-09-29,ACTUAL,2019-09-29,2020-03,2020-03-31,2023-02-08,ACTUAL,2023-02-08,2023-02-08,ACTUAL,2023-02-08,,INTERVENTIONAL,,,A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy,A Study Evaluating Safety and Efficacy of CBM.CD20 CAR-T(C-CAR066) in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy,COMPLETED,,PHASE1,7.0,ACTUAL,"Institute of Hematology & Blood Diseases Hospital, China",,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,OTHER,,,,,,,2023,1.0
NCT04542070,,2020-09-01,2023-07-12,,2024-06-03,2020-09-01,2020-09-09,ACTUAL,2023-08-23,2023-09-13,ACTUAL,,,,2024-06-03,2024-06-04,ACTUAL,2020-11-09,ACTUAL,2020-11-09,2024-06,2024-06-30,2023-04-17,ACTUAL,2023-04-17,2022-07-13,ACTUAL,2022-07-13,,INTERVENTIONAL,SOLAR,,A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed,"A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months From a Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in HIV-1 Infected Adults Who Are Virologically Suppressed",COMPLETED,,PHASE3,687.0,ACTUAL,ViiV Healthcare,,4.0,,,t,,,,f,t,f,,,,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/,YES,Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,INDUSTRY,,NCT03462810,AVAILABLE,,,,2023,0.0
NCT05528861,,2022-09-01,2024-09-03,,2024-09-24,2022-09-01,2022-09-06,ACTUAL,2024-09-24,2024-09-27,ACTUAL,,,,2024-09-24,2024-09-27,ACTUAL,2022-10-26,ACTUAL,2022-10-26,2024-09,2024-09-30,2024-04-18,ACTUAL,2024-04-18,2023-12-27,ACTUAL,2023-12-27,,INTERVENTIONAL,MAVERICK,Baseline analysis is reported on the safety population of the main study period. Baseline information of OLE subjects is not reported since it is already captured as part of the main study population.,A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria,"A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab in Adult Subjects With H-1 Antihistamine Refractory Chronic Spontaneous Urticaria",TERMINATED,,PHASE2,127.0,ACTUAL,Allakos Inc.,,2.0,,No longer pursuing development,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,INDUSTRY,,,,,,,2024,0.0
NCT01462578,,2011-06-22,,,2021-11-12,2011-10-28,2011-10-31,ESTIMATED,,,,,,,2021-11-12,2021-11-15,ACTUAL,2011-09,,2011-09-30,2021-11,2021-11-30,2021-02,ACTUAL,2021-02-28,2018-08,ACTUAL,2018-08-31,,INTERVENTIONAL,RELAZA2,,Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza),Treatment of Patients With MDS or AML With an Impending Hematological Relapse With Azacitidine (Vidaza),COMPLETED,,PHASE2,93.0,ACTUAL,Technische Universität Dresden,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,OTHER,,,,,,,2021,1.0
NCT02665364,,2015-11-17,2020-02-06,,2020-03-31,2016-01-22,2016-01-27,ESTIMATED,2020-03-25,2020-03-26,ACTUAL,,,,2020-03-31,2020-04-09,ACTUAL,2015-09-23,ACTUAL,2015-09-23,2020-03,2020-03-31,2020-02-04,ACTUAL,2020-02-04,2018-03-15,ACTUAL,2018-03-15,,INTERVENTIONAL,,A total of 185 subjects were randomized. One subject was randomized in IFN-K group and did not receive IFN-K. 184 subjects were treated; 91 subjects received IFN-K and 93 subjects received placebo.,Phase IIb Study of IFN-K in Systemic Lupus Erythematosus,"A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus",TERMINATED,,PHASE2,185.0,ACTUAL,Neovacs,,2.0,,Reorganization proceedings of the sponsor,f,,,,t,,,,,,,,,,,,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,INDUSTRY,,,,,,,2020,0.0
NCT03529084,,2018-04-18,,,2019-11-21,2018-05-07,2018-05-18,ACTUAL,,,,,,,2019-11-21,2019-11-22,ACTUAL,2018-07-24,ESTIMATED,2018-07-24,2019-11,2019-11-30,2024-06-03,ESTIMATED,2024-06-03,2020-08-13,ESTIMATED,2020-08-13,,INTERVENTIONAL,,,Phase III Study of Nazartinib (EGF816) Versus Erlotinib/Gefitinib in First-line Locally Advanced / Metastatic NSCLC With EGFR Activating Mutations,"A Randomized, Open-label, Phase III Study of Single Agent Nazartinib Versus Investigator's Choice (Erlotinib or Gefitinib) as First-Line Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Activating Mutations",WITHDRAWN,,PHASE3,0.0,ACTUAL,Novartis,,2.0,,Decision by Sponsor not to continue with the trial.,,,,,t,t,f,,,,,,,,,UNDECIDED,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.",2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,INDUSTRY,,,,,,,2024,0.0
NCT02847637,,2016-07-26,2018-09-14,,2022-10-19,2016-07-26,2016-07-28,ESTIMATED,2018-10-19,2018-11-14,ACTUAL,,,,2022-10-19,2022-11-16,ACTUAL,2016-09-27,ACTUAL,2016-09-27,2022-10,2022-10-31,2022-05-12,ACTUAL,2022-05-12,2017-09-15,ACTUAL,2017-09-15,,INTERVENTIONAL,HAVEN 3,,A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors,"A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients Without Inhibitors",COMPLETED,,PHASE3,152.0,ACTUAL,Hoffmann-La Roche,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:12:51.34593,2024-10-15 22:12:51.34593,INDUSTRY,,,,,,,2022,1.0
NCT04727606,,2020-11-17,,,2022-11-22,2021-01-22,2021-01-27,ACTUAL,,,,,,,2022-11-22,2022-11-28,ACTUAL,2023-01-15,ESTIMATED,2023-01-15,2022-11,2022-11-30,2024-06-15,ESTIMATED,2024-06-15,2024-01-15,ESTIMATED,2024-01-15,,INTERVENTIONAL,Ure-Na,,Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence,Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence,WITHDRAWN,,PHASE2,0.0,ACTUAL,Centre hospitalier de l'Université de Montréal (CHUM),,1.0,,We never got Health Canada approval,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,OTHER,,,,,,,2024,0.0
NCT04382586,,2020-05-07,2022-01-31,,2022-02-25,2020-05-07,2020-05-11,ACTUAL,2022-02-25,2022-03-02,ACTUAL,,,,2022-02-25,2022-03-02,ACTUAL,2020-07-06,ACTUAL,2020-07-06,2022-02,2022-02-28,2021-02-01,ACTUAL,2021-02-01,2021-02-01,ACTUAL,2021-02-01,,INTERVENTIONAL,,The Intent-to-Treat (ITT) Analysis Set includes all randomized participants,Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants,"A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Zanubrutinib Treatment in Patients Hospitalized for COVID-19 Infection and Pulmonary Distress",COMPLETED,,PHASE2,63.0,ACTUAL,BeiGene,,2.0,,,f,,,,t,t,f,,,f,,,,,,YES,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,INDUSTRY,,,,,,,2021,1.0
NCT03367689,,2017-11-24,,,2023-02-21,2017-12-04,2017-12-11,ACTUAL,,,,,,,2023-02-21,2023-02-22,ACTUAL,2018-04-17,ACTUAL,2018-04-17,2022-06,2022-06-30,2021-12-31,ACTUAL,2021-12-31,2021-07-31,ACTUAL,2021-07-31,,INTERVENTIONAL,NOBROLA,,A Two-stage Simon Design Phase II Study for Non-BRCA MBC Patients With HRD Treated With Olaparib Single Agent,A Two-stage Simon Design Phase II Study for NOn-BRCA Metastatic BReast Cancer (MBC) Patients With Homologous Recombination Deficiency Treated With OLAparib Single Agent,TERMINATED,,PHASE2,7.0,ACTUAL,MedSIR,,1.0,,Very slow recruitment due to subject profile,f,,,,f,f,f,,,,,,,,,,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,OTHER,,,,,,,2021,0.0
NCT03088878,,2017-03-02,,,2024-09-26,2017-03-22,2017-03-23,ACTUAL,,,,,,,2024-09-26,2024-09-27,ACTUAL,2018-01-03,ACTUAL,2018-01-03,2024-09,2024-09-30,2024-09-25,ACTUAL,2024-09-25,2024-09-25,ACTUAL,2024-09-25,,INTERVENTIONAL,,,A Study of Cirmtuzumab and Ibrutinib in Patients With B-Cell Lymphoid Malignancies,"A Phase 1b/2 Study of the ROR1-Targeting Monoclonal Antibody, Cirmtuzumab (UC-961), and the Bruton Tyrosine Kinase Inhibitor, Ibrutinib, in Patients With B-Cell Lymphoid Malignancies",COMPLETED,,PHASE1/PHASE2,102.0,ACTUAL,"Oncternal Therapeutics, Inc",,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,INDUSTRY,,,,,,,2024,1.0
NCT05435742,,2022-06-14,,,2024-04-11,2022-06-23,2022-06-28,ACTUAL,,,,,,,2024-04-11,2024-04-12,ACTUAL,2022-10-27,ACTUAL,2022-10-27,2024-04,2024-04-30,2024-03-17,ACTUAL,2024-03-17,2024-03-17,ACTUAL,2024-03-17,,INTERVENTIONAL,,,SON-080 in Patients With Persistent Chemotherapy-induced Peripheral Neuropathy (CIPN),"A Randomized, Double-blind, Placebo-controlled Phase 1b/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Repeated Subcutaneous Administration of SON-080 in Patients With Persistent Chemotherapy-induced Peripheral Neuropathy (CIPN) After the End of Chemotherapeutic Treatment",TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,Sonnet BioTherapeutics,,3.0,,Lack of Enrollment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,INDUSTRY,,,,,,,2024,0.0
NCT03399578,,2018-01-08,,,2021-10-12,2018-01-12,2018-01-16,ACTUAL,,,,,,,2021-10-12,2021-10-20,ACTUAL,2018-03-14,ACTUAL,2018-03-14,2021-10,2021-10-31,2021-09-17,ACTUAL,2021-09-17,2021-09-17,ACTUAL,2021-09-17,,INTERVENTIONAL,,,Safety and Immunogenicity of a Candidate MERS-CoV Vaccine (MERS001),A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Vaccine ChAdOx1 MERS in UK Healthy Adult Volunteers,TERMINATED,,PHASE1,29.0,ACTUAL,University of Oxford,,5.0,,"The scientific questions proposed remain relevant, but will now be addressed in a larger phase II immunogenicity trial of the ChAdOx1 MERS vaccine given at 2 doses.",f,,,,,f,f,,,,,,,,,,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,OTHER,,,,,,,2021,0.0
NCT04362332,,2020-04-20,,,2020-06-17,2020-04-23,2020-04-24,ACTUAL,,,,,,,2020-06-17,2020-06-19,ACTUAL,2020-04-14,ACTUAL,2020-04-14,2020-06,2020-06-30,2020-06-08,ACTUAL,2020-06-08,2020-06-08,ACTUAL,2020-06-08,,INTERVENTIONAL,ARCHAIC,,"Chloroquine, Hydroxychloroquine or Only Supportive Care in Patients AdmItted With Moderate to Severe COVID-19","An Open Label Cluster Randomized Controlled Trial of Chloroquine, Hydroxychloroquine or Only Supportive Care in Patients AdmItted With Moderate to Severe COVID-19",TERMINATED,,PHASE4,25.0,ACTUAL,UMC Utrecht,,3.0,,"Currently, almost no patients admitted to Dutch hospitals. If any effect of HCQ is to be expected we need more than 1000 inclusions",f,,,,t,f,f,,,f,,,12 months,,,YES,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,OTHER,,,,,,,2020,0.0
NCT02354911,,2015-01-27,,,2024-02-16,2015-01-29,2015-02-03,ESTIMATED,,,,,,,2024-02-16,2024-02-20,ACTUAL,2015-10,,2015-10-31,2024-02,2024-02-29,2024-02-16,ACTUAL,2024-02-16,2024-02-16,ACTUAL,2024-02-16,,INTERVENTIONAL,,,Autologous Immunoregulatory Dendritic Cells for Type 1 Diabetes Therapy,"A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study of the Safety and Efficacy of Autologous Immunoregulatory Dendritic Cells in Patients With Type 1 Diabetes",WITHDRAWN,,PHASE2,0.0,ACTUAL,"DiaVacs, Inc.",,2.0,,Funding for study not procured.,f,,,,t,,,,,,,,,,,,,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,INDUSTRY,,,,,,,2024,0.0
NCT03840200,,2019-02-11,2022-12-02,,2023-10-26,2019-02-11,2019-02-15,ACTUAL,2023-10-26,2023-10-30,ACTUAL,,,,2023-10-26,2023-10-30,ACTUAL,2019-06-12,ACTUAL,2019-06-12,2023-10,2023-10-31,2022-01-04,ACTUAL,2022-01-04,2021-12-07,ACTUAL,2021-12-07,,INTERVENTIONAL,,Safety population included all participants who were treated with at least one dose of the study treatment.,"A Study Evaluating the Safety, Pharmacokinetics and Efficacy of Ipatasertib Administered in Combination With Rucaparib in Participants With Advanced Breast, Ovarian Cancer, and Prostate Cancer.","A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Rucaparib in Patients With Advanced Breast, Ovarian, or Prostate Cancer",COMPLETED,,PHASE1,51.0,ACTUAL,Hoffmann-La Roche,,5.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 22:18:30.615103,2024-10-15 22:18:30.615103,INDUSTRY,,,,,,,2022,0.0
NCT04382911,,2020-05-06,2022-11-04,,2023-05-25,2020-05-06,2020-05-11,ACTUAL,2023-02-06,2023-02-09,ACTUAL,,,,2023-05-25,2023-05-30,ACTUAL,2020-08-07,ACTUAL,2020-08-07,2022-07,2022-07-31,2022-07-11,ACTUAL,2022-07-11,2022-07-11,ACTUAL,2022-07-11,,INTERVENTIONAL,,,Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI,Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI,COMPLETED,,PHASE2,8.0,ACTUAL,"University of North Carolina, Chapel Hill",,1.0,,,f,,,,f,t,f,,,,,,9 to 36 months following publication,"The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.",,YES,"Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.",2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,OTHER,,,,,,,2022,1.0
NCT04543955,,2020-09-02,2023-06-02,,2023-06-02,2020-09-02,2020-09-10,ACTUAL,2023-06-02,2023-06-27,ACTUAL,,,,2023-06-02,2023-06-27,ACTUAL,2021-09-13,ACTUAL,2021-09-13,2023-06,2023-06-30,2022-06-03,ACTUAL,2022-06-03,2022-06-03,ACTUAL,2022-06-03,,INTERVENTIONAL,,Research cancelled and 0 participants enrolled in Arm 2,Telotristat With Lutathera in Neuroendocrine Tumors,Study of Telotristat (Xermelo) in Combination With Luetetium Lu177 Dotatate (Lutathera) in Well-Differentiated Neuroendocrine Tumors,TERMINATED,,PHASE2,1.0,ACTUAL,University of Kentucky,,2.0,,Sponsor cancelled research,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,OTHER,,,,,,,2022,0.0
NCT04569786,,2020-09-24,2021-12-22,,2021-12-22,2020-09-24,2020-09-30,ACTUAL,2021-12-22,2021-12-29,ACTUAL,,,,2021-12-22,2021-12-29,ACTUAL,2020-10-29,ACTUAL,2020-10-29,2021-12,2021-12-31,2021-02-18,ACTUAL,2021-02-18,2021-02-18,ACTUAL,2021-02-18,,INTERVENTIONAL,,,Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001),"A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Safety and Immunogenicity of V590 in Healthy Adults",TERMINATED,,PHASE1,232.0,ACTUAL,Merck Sharp & Dohme LLC,The study was terminated based on an interim assessment of immunogenicity.,9.0,,The study was terminated based on an interim assessment of immunogenicity.,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 17:25:54.913917,2024-10-16 17:25:54.913917,INDUSTRY,,,,,,,2021,0.0
NCT04853043,,2021-04-16,,,2024-06-10,2021-04-20,2021-04-21,ACTUAL,,,,,,,2024-06-10,2024-06-11,ACTUAL,2021-11-03,ACTUAL,2021-11-03,2024-06,2024-06-30,2024-05-03,ACTUAL,2024-05-03,2024-02-20,ACTUAL,2024-02-20,,INTERVENTIONAL,APK Mutant,,"Cetuximab in Third Line for Mutant APC, TP53 and RAS Patients With Refractory Metastatic Colorectal Cancer","APK Mutant: A Single Arm Phase II Study of Cetuximab in Third Line for Mutant APC, TP53 and RAS Patients With Refractory Metastatic Colorectal Cancer",TERMINATED,,PHASE2,7.0,ACTUAL,University of Utah,,1.0,,"PI Determination - Slow recruitment, funding concerns, poor response to treatment",f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,OTHER,,,,,,,2024,0.0
NCT03434041,,2018-02-09,2022-04-12,,2024-04-24,2018-02-09,2018-02-15,ACTUAL,2022-05-23,2022-05-24,ACTUAL,,,,2024-04-24,2024-04-26,ACTUAL,2018-05-25,ACTUAL,2018-05-25,2024-04,2024-04-30,2021-04-13,ACTUAL,2021-04-13,2021-04-13,ACTUAL,2021-04-13,,INTERVENTIONAL,,,"A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression","A Randomized, Double-blind, Multicenter Active-controlled Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression",COMPLETED,,PHASE3,252.0,ACTUAL,"Janssen Research & Development, LLC","As esketamine has known transient dissociative effects that are difficult to blind, these specific treatment-emergent events could have biased the staff who provided and observed the dosing. Therefore, to ensure an unbiased efficacy evaluation, independent, remote (by telephone), blinded MADRS raters were used to assess the treatment response.",2.0,,,t,,,,f,t,f,,,,,,,,,,,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,INDUSTRY,,NCT03829579,APPROVED_FOR_MARKETING,,,,2021,1.0
NCT00867048,,2009-03-20,2023-07-19,,2024-02-29,2009-03-20,2009-03-23,ESTIMATED,2023-12-19,2023-12-20,ACTUAL,,,,2024-02-29,2024-03-04,ACTUAL,2009-04-15,ACTUAL,2009-04-15,2024-02,2024-02-29,2022-07-27,ACTUAL,2022-07-27,2022-07-27,ACTUAL,2022-07-27,,INTERVENTIONAL,START,,Strategic Timing of Antiretroviral Treatment,Strategic Timing of AntiRetroviral Treatment,COMPLETED,,PHASE4,4688.0,ACTUAL,University of Minnesota,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,OTHER,,,,,,,2022,1.0
NCT04979949,,2021-07-15,,,2023-11-28,2021-07-26,2021-07-28,ACTUAL,,,,,,,2023-11-28,2023-11-29,ACTUAL,2021-07-12,ACTUAL,2021-07-12,2023-02,2023-02-28,2022-06-06,ACTUAL,2022-06-06,2022-03-09,ACTUAL,2022-03-09,,INTERVENTIONAL,,,Booster Vaccination Against COVID-19,"Double-Blind, Randomized, Controlled, Multi-Centered, Phase 2 Clinical Trial to Determine the Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2",COMPLETED,,PHASE2,222.0,ACTUAL,Health Institutes of Turkey,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,OTHER_GOV,,,,,,,2022,1.0
NCT03618264,,2018-07-30,,,2020-02-15,2018-08-04,2018-08-07,ACTUAL,,,,,,,2020-02-15,2020-02-18,ACTUAL,2019-04-04,ACTUAL,2019-04-04,2020-02,2020-02-29,2020-02-13,ACTUAL,2020-02-13,2019-08-15,ACTUAL,2019-08-15,,INTERVENTIONAL,,,Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Postoperative Pain After Craniotomy,Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine vs. Ropivacaine for Relief of Postoperative Pain After Craniotomy in Adults,COMPLETED,,PHASE4,140.0,ACTUAL,Beijing Tiantan Hospital,,2.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,OTHER,,,,,,,2020,1.0
NCT01856439,,2013-05-14,,,2022-04-27,2013-05-16,2013-05-17,ESTIMATED,,,,,,,2022-04-27,2022-05-03,ACTUAL,2011-05,,2011-05-31,2022-04,2022-04-30,2022-04,ACTUAL,2022-04-30,2021-11,ACTUAL,2021-11-30,,INTERVENTIONAL,,,Long Term Safety and Efficacy Study of ProSavin in Parkinson's Disease,"A Multicentre, Open-label Study to Determine the Long Term Safety, Tolerability and Efficacy of ProSavin in Patients With Bilateral, Idiopathic Parkinson's Disease.",TERMINATED,,PHASE1/PHASE2,15.0,ACTUAL,Sio Gene Therapies,,1.0,,"As a result of termination of development of Prosavin, it is no longer possible for Sio to either commence or to continue any related clinical trials.",f,,,,t,,,,,,,,,,,NO,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,INDUSTRY,,,,,,,2022,0.0
NCT02096588,,2014-03-14,2019-05-14,,2024-06-12,2014-03-24,2014-03-26,ESTIMATED,2019-06-06,2019-06-26,ACTUAL,,,,2024-06-12,2024-07-09,ACTUAL,2014-05-20,ACTUAL,2014-05-20,2024-06,2024-06-30,2023-07-26,ACTUAL,2023-07-26,2017-04-25,ACTUAL,2017-04-25,,INTERVENTIONAL,,,Detection and Prevention of Anthracycline-Related Cardiac Toxicity With Concurrent Simvastatin,Detection and Prevention of Anthracycline-Related Cardiac Toxicity With Concurrent Simvastatin,TERMINATED,,PHASE2,34.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,2.0,,The Principal Investigator left Johns Hopkins,f,,,,f,,,,,,,,,,,NO,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,OTHER,,,,,,,2023,0.0
NCT03701711,,2018-10-08,,,2024-09-25,2018-10-08,2018-10-10,ACTUAL,,,,,,,2024-09-25,2024-09-27,ACTUAL,2018-09-10,ACTUAL,2018-09-10,2023-03,2023-03-31,2022-02-28,ACTUAL,2022-02-28,2022-02-28,ACTUAL,2022-02-28,,INTERVENTIONAL,,,Lenalidomide in Anti-MAG Neuropathy: Phase 1b Study,A Phase I Study of Lenalidomide in Combination with Dexamethasone in Anti-MAG Demyelinating Sensorimotor Neuropathy,TERMINATED,,PHASE1,11.0,ACTUAL,Ohio State University,,1.0,,Higher than expected occurrence of VTE (venous thromboembolic event),f,,,,f,t,f,,,t,,,,,,,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,OTHER,,,,,,,2022,0.0
NCT04655183,,2020-11-27,,,2021-06-24,2020-11-27,2020-12-07,ACTUAL,,,,,,,2021-06-24,2021-06-30,ACTUAL,2020-12-01,ESTIMATED,2020-12-01,2021-06,2021-06-30,2023-09-01,ESTIMATED,2023-09-01,2023-09-01,ESTIMATED,2023-09-01,,INTERVENTIONAL,,,Study of M4344 in Combination With Niraparib,A Phase I Dose Escalation Study of ATR Inhibitor M4344 in Combination With Niraparib in Participants With Advanced Solid Tumors Followed by Phase II Cohort Expansion in Participants With Breast Cancer With DNA Damage Response (DDR) Mutations,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,EMD Serono,,5.0,,Trial withdrawn based on portfolio prioritization; oral ATRi M1774 in combination with niraparib is under investigation in DDRiver Solid Tumor 301,f,,,,t,t,f,,,,,,,,,YES,"Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html",2024-10-15 22:18:30.615103,2024-10-15 22:18:30.615103,INDUSTRY,,,,,,,2023,0.0
NCT05010525,,2021-08-11,,,2023-03-16,2021-08-11,2021-08-18,ACTUAL,,,,,,,2023-03-16,2023-03-17,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2022-07,2022-07-31,2022-11-14,ACTUAL,2022-11-14,2022-11-14,ACTUAL,2022-11-14,,INTERVENTIONAL,REACH,,"A Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG 016 Monotherapy in Patients With Advanced Solid Tumors","A Phase Ib/II Open-label, Multi-centre, Dose Finding Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG 016 Monotherapy in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,Antengene Corporation,,4.0,,Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study,f,,,,,f,f,,,,,,,,,,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,INDUSTRY,,,,,,,2022,0.0
NCT04632706,,2020-10-26,2021-12-14,,2021-12-22,2020-11-16,2020-11-17,ACTUAL,2021-12-22,2021-12-27,ACTUAL,,,,2021-12-22,2021-12-27,ACTUAL,2020-09-22,ACTUAL,2020-09-22,2021-12,2021-12-31,2021-03-09,ACTUAL,2021-03-09,2021-03-09,ACTUAL,2021-03-09,,INTERVENTIONAL,,,Exploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19,"A Randomised, Double-Blind, Placebo-Controlled, Exploratory Phase I Trial Assessing the Pharmacokinetic Profile, Safety and Tolerability of a Continuous Daily Dosing Regimen of Active IMP in Healthy Volunteers",COMPLETED,,PHASE1,24.0,ACTUAL,MedinCell S.A,,4.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,INDUSTRY,,,,,,,2021,1.0
NCT04054687,,2019-03-12,,,2020-09-09,2019-08-12,2019-08-13,ACTUAL,,,,,,,2020-09-09,2020-09-11,ACTUAL,2019-11-07,ACTUAL,2019-11-07,2020-09,2020-09-30,2021-05,ESTIMATED,2021-05-31,2021-04,ESTIMATED,2021-04-30,,INTERVENTIONAL,,,Intranasal TXA for Anterior Epistaxis in the Emergency Department,Intranasal TXA for Anterior Epistaxis in the Emergency Department,SUSPENDED,,PHASE2,86.0,ESTIMATED,Mercy Health Ohio,,2.0,,Due to coronavirus pandemic,f,,,,f,t,f,,,t,,,,,,,,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,OTHER,,,,,,,2021,0.0
NCT04764630,,2021-02-16,2022-03-17,,2023-11-07,2021-02-19,2021-02-21,ACTUAL,2022-03-17,2022-07-15,ACTUAL,,,,2023-11-07,2024-04-19,ACTUAL,2021-03-01,ACTUAL,2021-03-01,2023-11,2023-11-30,2021-03-20,ACTUAL,2021-03-20,2021-03-20,ACTUAL,2021-03-20,,INTERVENTIONAL,,,Clinical Study to Investigate the Pharmacokinetics of Multiple Repeated Doses of Intranasal Naloxone,Clinical Study to Investigate the Pharmacokinetics of Multiple Repeated Doses of Intranasal Naloxone,COMPLETED,,PHASE1,21.0,ACTUAL,Food and Drug Administration (FDA),,3.0,,,f,,,,f,t,f,,,f,,,"Individual patient data will be shared at the time of the primary publication, which is anticipated to be within 1 year of study completion.",No restrictions.,,YES,Individual patient data will be shared at the time of the primary publication.,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,FED,,,,,,,2021,1.0
NCT05021484,,2021-08-12,,,2024-04-17,2021-08-19,2021-08-25,ACTUAL,,,,,,,2024-04-17,2024-04-18,ACTUAL,2021-10-06,ACTUAL,2021-10-06,2024-04,2024-04-30,2024-03-07,ACTUAL,2024-03-07,2024-03-07,ACTUAL,2024-03-07,,INTERVENTIONAL,,,Felzartamab in Late Antibody-Mediated Rejection,"Safety, Tolerability and Efficacy of Monoclonal CD38 Antibody Felzartamab in Late Antibody-Mediated Renal Allograft Rejection - A Phase 2 Pilot Trial",COMPLETED,,PHASE2,22.0,ACTUAL,Medical University of Vienna,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,OTHER,,,,,,,2024,1.0
NCT03476317,,2018-01-08,2021-11-23,,2022-02-08,2018-03-19,2018-03-26,ACTUAL,2022-02-08,2022-02-09,ACTUAL,,,,2022-02-08,2022-02-09,ACTUAL,2018-07-12,ACTUAL,2018-07-12,2022-02,2022-02-28,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,Holiday,An identical study was simultaneously enrolling adult patients and results from the adult study were sufficient to make a conclusion without enrolling children. (NCT02765256),Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease,An Open-Label Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease,COMPLETED,,PHASE2,10.0,ACTUAL,Children's Hospital of Philadelphia,Group 1 study was not completed.,3.0,,,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,OTHER,,,,,,,2020,1.0
NCT04052698,,2019-08-09,2023-03-30,,2023-09-29,2019-08-09,2019-08-12,ACTUAL,2023-09-29,2023-10-25,ACTUAL,,,,2023-09-29,2023-10-25,ACTUAL,2020-06-18,ACTUAL,2020-06-18,2023-09,2023-09-30,2022-04-23,ACTUAL,2022-04-23,2022-04-23,ACTUAL,2022-04-23,,INTERVENTIONAL,,,Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With VWD,Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With Von Willebrand Disease (VWD),COMPLETED,,PHASE3,43.0,ACTUAL,Octapharma,,1.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,INDUSTRY,,,,,,,2022,1.0
NCT02846883,,2016-07-25,2022-10-07,,2024-06-27,2016-07-25,2016-07-27,ESTIMATED,2024-06-27,2024-08-09,ACTUAL,,,,2024-06-27,2024-08-09,ACTUAL,2016-12-05,ACTUAL,2016-12-05,2024-06,2024-06-30,2021-09-30,ACTUAL,2021-09-30,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,VIVAAA,,Safety and Efficacy of Allogeneic MSCs in Promoting T-regulatory Cells in Patients With Small Abdominal Aortic Aneurysms,Mesenchymal Stem Cells Induce Regulatory T Cells in Patients With Aortic Aneurysm,TERMINATED,,PHASE1,28.0,ACTUAL,VA Office of Research and Development,The major limitation of this trial is that it did not complete enrollment of the planned 36 subjects. This is because the trial was put on hold during the COVID pandemic and when the Richard Roudebush VAMV opened for elective procedures the VA Merit grant had expired.,3.0,,Early Termination as required by VA DSMB due to slow enrollment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,FED,,,,,,,2021,0.0
NCT04193176,,2019-12-09,2023-07-26,,2023-08-29,2019-12-09,2019-12-10,ACTUAL,2023-08-29,2023-09-22,ACTUAL,,,,2023-08-29,2023-09-22,ACTUAL,2020-05-10,ACTUAL,2020-05-10,2023-08,2023-08-31,2022-09-02,ACTUAL,2022-09-02,2022-08-18,ACTUAL,2022-08-18,,INTERVENTIONAL,,,Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042),"A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Women With Chronic Cough and Stress Urinary Incontinence",COMPLETED,,PHASE3,376.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,INDUSTRY,,,,,,,2022,1.0
NCT04167085,,2019-11-14,2022-06-24,,2022-06-24,2019-11-14,2019-11-18,ACTUAL,2022-06-24,2022-07-20,ACTUAL,,,,2022-06-24,2022-07-20,ACTUAL,2017-12-18,ACTUAL,2017-12-18,2022-06,2022-06-30,2021-06-01,ACTUAL,2021-06-01,2021-06-01,ACTUAL,2021-06-01,,INTERVENTIONAL,NOSTRIL,,NOrth American Study for the Treatment of Recurrent epIstaxis With DoxycycLine: The NOSTRIL Trial,NOrth American Study for the Treatment of Recurrent epIstaxis With DoxycycLine: The NOSTRIL Trial,COMPLETED,,PHASE4,26.0,ACTUAL,"University of California, Los Angeles",,2.0,,,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 22:18:30.615103,2024-10-15 22:18:30.615103,OTHER,,,,,,,2021,1.0
NCT03701763,,2018-08-30,2023-10-03,2022-10-27,2024-06-04,2018-10-09,2018-10-10,ACTUAL,2023-11-14,2023-12-07,ACTUAL,,2023-12-07,ACTUAL,2024-06-04,2024-06-14,ACTUAL,2018-12-19,ACTUAL,2018-12-19,2024-06,2024-06-30,2023-03-27,ACTUAL,2023-03-27,2022-04-25,ACTUAL,2022-04-25,,INTERVENTIONAL,,"Measured in the intent-to-treat (ITT) population, which included all participants who were randomized.",Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis,"A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN PEDIATRIC SUBJECTS FROM 6 THROUGH 17 YEARS WITH MODERATE TO SEVERE PLAQUE PSORIASIS",TERMINATED,,PHASE3,245.0,ACTUAL,Amgen,,3.0,,Last Subject Enrolled was 30-Dec-2021 - The Recruitment Status has to be updated to Terminated. LSLV was achieved 27-Mar-2023\],t,,,,t,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,INDUSTRY,,NCT03740516,NO_LONGER_AVAILABLE,,,,2023,0.0
NCT04431635,,2020-06-11,,,2024-09-25,2020-06-12,2020-06-16,ACTUAL,,,,,,,2024-09-25,2024-09-27,ACTUAL,2020-06-15,ACTUAL,2020-06-15,2024-09,2024-09-30,2023-11-14,ACTUAL,2023-11-14,2023-11-14,ACTUAL,2023-11-14,,INTERVENTIONAL,,,"Dose De-escalation Study of the PI3k Alpha/Delta Inhibitor, Copanlisib Given in Combination With the Immunotherapeutic Agents, Nivolumab and Rituximab in Patients With Relapsed/Refractory Indolent Lymphoma","Phase IB Dose De-escalation Study of the PI3k Alpha/Delta Inhibitor, Copanlisib Given in Combination With the Immunotherapeutic Agents, Nivolumab and Rituximab in Patients With Relapsed/Refractory Indolent Lymphoma.Big Ten Cancer Research Consortium BTCRC-LYM17-145",TERMINATED,,PHASE1,6.0,ACTUAL,University of Michigan Rogel Cancer Center,,1.0,,Loss of study funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,OTHER,,,,,,,2023,0.0
NCT05424380,,2022-06-15,,,2024-09-25,2022-06-15,2022-06-21,ACTUAL,,,,,,,2024-09-25,2024-09-27,ACTUAL,2022-09-20,ACTUAL,2022-09-20,2024-09,2024-09-30,2024-03-04,ACTUAL,2024-03-04,2024-03-04,ACTUAL,2024-03-04,,INTERVENTIONAL,,,"A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS","A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D and Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (HR-MDS)",TERMINATED,,PHASE1,18.0,ACTUAL,GlaxoSmithKline,,2.0,,The protocol was terminated on the basis of a reprioritization of organizational allocation of resources for clinical research programs.,f,,,,f,f,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,INDUSTRY,,,,,,,2024,0.0
NCT03670810,,2018-09-12,2021-06-11,,2022-06-29,2018-09-12,2018-09-14,ACTUAL,2021-06-11,2021-07-02,ACTUAL,,,,2022-06-29,2022-07-29,ACTUAL,2019-06-24,ACTUAL,2019-06-24,2022-06,2022-06-30,2021-07-08,ACTUAL,2021-07-08,2020-06-12,ACTUAL,2020-06-12,,INTERVENTIONAL,,"All randomized participants who were treated with at least 1 dose of study drug, regardless of whether or not they undergo any study assessments.",A Study of Lasmiditan (LY573144) Over Four Migraine Attacks,Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks,COMPLETED,,PHASE3,1633.0,ACTUAL,Eli Lilly and Company,,9.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,INDUSTRY,,,,,,,2021,1.0
NCT04424966,,2020-05-27,,,2024-03-25,2020-06-05,2020-06-11,ACTUAL,,,,,,,2024-03-25,2024-03-27,ACTUAL,2020-07-21,ACTUAL,2020-07-21,2024-03,2024-03-31,2023-04-27,ACTUAL,2023-04-27,2023-04-27,ACTUAL,2023-04-27,,INTERVENTIONAL,,,Infigratinib in Recurrent High-Grade Glioma Patients,A Phase 0 Study of Infigratinib in Recurrent High-Grade Glioma Participants Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With PK Triggered Expansion Cohort,TERMINATED,,EARLY_PHASE1,7.0,ACTUAL,"St. Joseph's Hospital and Medical Center, Phoenix",,1.0,,Study drug no longer available.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,OTHER,,,,,,,2023,0.0
NCT04227938,,2020-01-06,,,2023-08-24,2020-01-10,2020-01-14,ACTUAL,,,,,,,2023-08-24,2023-08-28,ACTUAL,2020-05-11,ACTUAL,2020-05-11,2020-08,2020-08-31,2020-05-21,ACTUAL,2020-05-21,2020-05-21,ACTUAL,2020-05-21,,INTERVENTIONAL,Balance,,ALPN-101 in Steroid-resistant or Steroid-refractory Acute GVHD,An Open-label Study of ALPN-101 in Steroid-resistant or Steroid-refractory Acute Graft Versus Host Disease (aGVHD),TERMINATED,,PHASE1,1.0,ACTUAL,"Alpine Immune Sciences, Inc.",,1.0,,Change in sponsor strategy,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,INDUSTRY,,,,,,,2020,0.0
NCT02948426,,2016-10-27,2021-04-26,,2023-09-26,2016-10-27,2016-10-28,ESTIMATED,2021-05-26,2021-06-16,ACTUAL,,,,2023-09-26,2023-10-19,ACTUAL,2017-02-08,ACTUAL,2017-02-08,2023-09,2023-09-30,2020-09-29,ACTUAL,2020-09-29,2020-09-29,ACTUAL,2020-09-29,,INTERVENTIONAL,,,"Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimmune (Interferon Gamma-1b) in Women With Recurrent or Refractory Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer","Phase 1 Study of Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimmune (Interferon Gamma-1b) in Women With Recurrent or Refractory Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer",TERMINATED,,PHASE1,18.0,ACTUAL,National Institutes of Health Clinical Center (CC),,5.0,,Study was closed to accrual due to lack of drug supply.,f,,,,f,t,f,,,,,,Clinical data will be available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.,,YES,"All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).",2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,NIH,,,,,,,2020,0.0
NCT03714555,,2018-10-09,2023-08-24,,2023-09-26,2018-10-18,2018-10-22,ACTUAL,2023-09-26,2023-10-18,ACTUAL,,,,2023-09-26,2023-10-18,ACTUAL,2019-10-17,ACTUAL,2019-10-17,2023-09,2023-09-30,2020-07-29,ACTUAL,2020-07-29,2020-07-22,ACTUAL,2020-07-22,,INTERVENTIONAL,,Study was closed due to low subject enrollment at site.,"Disulfiram-Copper Gluconate in Met Pancreas Cancer w Rising CA19-9 on Abraxane-Gemzar, FOLFIRINOX or Gemcitabine",A Phase II Pilot Study of Disulfiram and Copper Gluconate in Patients With Metastatic Pancreatic Cancer and Rising CA-19-9 Levels While Receiving Abraxane-Gemcitabine or FOLFIRINOX or Single-Agent Gemcitabine,TERMINATED,,PHASE2,1.0,ACTUAL,HonorHealth Research Institute,,3.0,,Study was closed due to low subject enrollment at site.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,OTHER,,,,,,,2020,0.0
NCT04044560,,2019-07-31,,,2022-02-03,2019-08-01,2019-08-05,ACTUAL,,,,,,,2022-02-03,2022-02-21,ACTUAL,2020-09-08,ACTUAL,2020-09-08,2022-02,2022-02-28,2022-02-02,ACTUAL,2022-02-02,2022-02-02,ACTUAL,2022-02-02,,INTERVENTIONAL,OZM-097,,Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant,"Blinatumomab for Minimal Residual Disease (MRD) in Pre-B Cell Acute Lymphoblastic Leukemia Patients Following Hematopoietic Cell Transplantation: A Canadian, Multicentre Trial",TERMINATED,,PHASE2,8.0,ACTUAL,University of British Columbia,,1.0,,"Slow enrolment, loss of funding",f,,,,t,t,f,,,t,,,,,,,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,OTHER,,,,,,,2022,0.0
NCT03730779,,2018-11-02,,,2020-03-05,2018-11-02,2018-11-05,ACTUAL,,,,,,,2020-03-05,2020-03-09,ACTUAL,2018-11-30,ACTUAL,2018-11-30,2020-03,2020-03-31,2020-01-01,ACTUAL,2020-01-01,2020-01-01,ACTUAL,2020-01-01,,INTERVENTIONAL,,,Oxygen Therapy for Retinal Ischemia,Normobaric Nocturnal Hyperoxia Therapy for Treating Ischemic-Related Retinal Conditions,WITHDRAWN,,PHASE4,0.0,ACTUAL,Beth Israel Deaconess Medical Center,,1.0,,lack of funding,f,,,,f,t,f,,,t,,,,,,NO,If researchers wish to access IPD they may contact us with their request,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,OTHER,,,,,,,2020,0.0
NCT03808740,,2019-01-16,2022-12-13,,2024-06-10,2019-01-16,2019-01-18,ACTUAL,2024-06-10,2024-09-27,ACTUAL,,,,2024-06-10,2024-09-27,ACTUAL,2018-07-01,ACTUAL,2018-07-01,2024-06,2024-06-30,2021-05-31,ACTUAL,2021-05-31,2021-05-31,ACTUAL,2021-05-31,,INTERVENTIONAL,RYGB,"Due to COVID-19 pandemic, recruitment was stopped, all the weight loss surgeries and non-essential procedures, were stopped. Due to high COVID -19 prevalence the Vanderbilt Weight Loss clinic (VWL) was closed for IN person visits. We could not recruit any participant for Non surgical weight loss category.",Orthostatic Intolerance After Bariatric Surgery,Orthostatic Intolerance After Bariatric Surgery,TERMINATED,,PHASE1,10.0,ACTUAL,Vanderbilt University Medical Center,,4.0,,"Due to COVID-19 pandemic, recruitment was stopped. All the weight loss surgeries were stopped.. Weight Loss clinic (VWL) was closed for IN person visits. We could not recruit any participant for Non surgical weight loss category.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,OTHER,,,,,,,2021,0.0
NCT03471988,,2018-02-26,,,2021-05-13,2018-03-14,2018-03-21,ACTUAL,,,,,,,2021-05-13,2021-05-14,ACTUAL,2018-04-16,ACTUAL,2018-04-16,2021-01,2021-01-31,2021-04-21,ACTUAL,2021-04-21,2021-04-21,ACTUAL,2021-04-21,,INTERVENTIONAL,,,Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep Mycosis,"A Phase 3, Multi-center, Open Label Study to Evaluate Safety and Efficacy of AK1820 for Treatment of Adult Japanese Patients With Deep Mycosis",COMPLETED,,PHASE3,103.0,ACTUAL,Asahi Kasei Pharma Corporation,,2.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,INDUSTRY,,,,,,,2021,1.0
NCT03864042,,2019-02-01,2023-07-07,,2024-05-17,2019-03-04,2019-03-06,ACTUAL,2024-05-17,2024-09-27,ACTUAL,,,,2024-05-17,2024-09-27,ACTUAL,2018-01-02,ACTUAL,2018-01-02,2024-05,2024-05-31,2023-05-29,ACTUAL,2023-05-29,2022-07-11,ACTUAL,2022-07-11,,INTERVENTIONAL,,Safety analysis population who were treated with encorafenib-binimetinib.,Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors,An Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered With Encorafenib and Binimetinib in Patients With BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors,COMPLETED,,PHASE1,56.0,ACTUAL,Pfizer,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,INDUSTRY,,,,,,,2023,0.0
NCT02538926,,2015-08-31,,,2018-11-09,2015-08-31,2015-09-02,ESTIMATED,,,,,,,2018-11-09,2018-11-14,ACTUAL,2018-07-01,ESTIMATED,2018-07-01,2018-11,2018-11-30,2021-07-30,ESTIMATED,2021-07-30,2020-07-30,ESTIMATED,2020-07-30,,INTERVENTIONAL,,,"Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride With Asparaginase in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma","A Phase II Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Asparaginase (DA-EPOCH-A) for Adults With Acute Lymphoblastic Leukemia/Lymphoma",WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Washington,,1.0,,Drugs unavailable,f,,,,f,t,f,,,,,,,,,,,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,OTHER,,,,,,,2021,0.0
NCT02379754,,2015-01-25,,,2020-09-09,2015-03-01,2015-03-05,ESTIMATED,,,,,,,2020-09-09,2020-09-11,ACTUAL,2015-01,,2015-01-31,2020-09,2020-09-30,2020-09,ACTUAL,2020-09-30,2019-06,ACTUAL,2019-06-30,,INTERVENTIONAL,,,Gentamicin Treatment Prior to Schwannoma Surgery - Residual Function,Gentamicin Treatment Prior to Vestibular Schwannoma Surgery in Patients With Definite Remaining Vestibular Function,WITHDRAWN,,PHASE4,0.0,ACTUAL,Lund University,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,OTHER,,,,,,,2020,0.0
NCT04000347,,2019-06-26,,,2022-09-11,2019-06-26,2019-06-27,ACTUAL,,,,,,,2022-09-11,2022-09-15,ACTUAL,2019-06-26,ACTUAL,2019-06-26,2022-09,2022-09-30,2022-04-01,ACTUAL,2022-04-01,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,,,A Study of Efficacy of Benzoyl Peroxide Regimens in Treatment of Unpleasant Foot Odor,A Study of Efficacy of Benzoyl Peroxide Regimens in Treatment of Unpleasant Foot Odor,WITHDRAWN,,PHASE4,0.0,ACTUAL,Mahidol University,,2.0,,"Due to covid 19 outbreaks, the study are suspended.",f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,OTHER,,,,,,,2022,0.0
NCT05421078,,2022-06-13,2024-09-03,,2024-09-03,2022-06-13,2022-06-16,ACTUAL,2024-09-03,2024-09-27,ACTUAL,,,,2024-09-03,2024-09-27,ACTUAL,2022-06-27,ACTUAL,2022-06-27,2024-09,2024-09-30,2023-04-21,ACTUAL,2023-04-21,2023-03-24,ACTUAL,2023-03-24,,INTERVENTIONAL,,Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.,A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.,"A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Dose-Finding Study to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy in Japanese Subjects.",COMPLETED,,PHASE2,108.0,ACTUAL,NewAmsterdam Pharma,,4.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,INDUSTRY,,,,,,,2023,1.0
NCT04083898,,2019-09-06,,,2024-03-17,2019-09-06,2019-09-10,ACTUAL,,,,,,,2024-03-17,2024-03-19,ACTUAL,2020-04-03,ACTUAL,2020-04-03,2024-03,2024-03-31,2024-03-07,ACTUAL,2024-03-07,2023-03-13,ACTUAL,2023-03-13,,INTERVENTIONAL,,,"Isatuximab, Bendamustine, and Prednisone in Refractory Multiple Myeloma","A Phase I/II Trial of Isatuximab, Bendamustine, and Prednisone in Refractory Multiple Myeloma",TERMINATED,,PHASE1,15.0,ACTUAL,Washington University School of Medicine,,4.0,,Decision made to not move forward with Phase II portion of trial,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,OTHER,,,,,,,2024,0.0
NCT05116787,,2021-11-02,,,2024-02-22,2021-11-02,2021-11-11,ACTUAL,,,,,,,2024-02-22,2024-02-23,ACTUAL,2021-10-26,ACTUAL,2021-10-26,2022-12,2022-12-31,2023-09-14,ACTUAL,2023-09-14,2023-09-14,ACTUAL,2023-09-14,,INTERVENTIONAL,REDEEM-2,,BCX9930 for the Treatment of PNH in Subjects Not Receiving Other Complement Inhibitor Therapy,"A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of PNH",TERMINATED,,PHASE2,12.0,ACTUAL,BioCryst Pharmaceuticals,,2.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,INDUSTRY,,,,,,,2023,0.0
NCT04111172,,2019-09-20,,,2024-05-09,2019-09-27,2019-10-01,ACTUAL,,,,,,,2024-05-09,2024-05-13,ACTUAL,2020-11-10,ACTUAL,2020-11-10,2024-05,2024-05-31,2024-12-31,ESTIMATED,2024-12-31,2024-07-01,ESTIMATED,2024-07-01,,INTERVENTIONAL,,,A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma,"A Phase 2A, Dose-Finding Study of Ad5.F35-hGCC-PADRE Vaccine in Adults With Gastrointestinal Adenocarcinomas at Risk of Relapse Post Definitive Surgery and Standard Therapy",SUSPENDED,,PHASE2,81.0,ESTIMATED,Thomas Jefferson University,,3.0,,Suspended until interim analysis is complete.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,OTHER,,,,,,,2024,0.0
NCT05344625,,2022-03-31,,,2024-01-22,2022-04-19,2022-04-25,ACTUAL,,,,,,,2024-01-22,2024-01-24,ACTUAL,2023-10-31,ACTUAL,2023-10-31,2024-01,2024-01-31,2024-03-15,ESTIMATED,2024-03-15,2024-03-15,ESTIMATED,2024-03-15,,INTERVENTIONAL,KAPTIVATED,,Ketamine-Assisted PsychoTherapy ViAbility in Treating Cancer-related Emotional Distress,Ketamine-Assisted Psychotherapy Viability in Treating Cancer-Related Emotional Distress,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Northwell Health,,1.0,,Study team is not moving forward with protocol,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,OTHER,,,,,,,2024,0.0
NCT03878524,,2019-03-14,,,2024-02-29,2019-03-15,2019-03-18,ACTUAL,,,,,,,2024-02-29,2024-03-04,ACTUAL,2020-04-01,ACTUAL,2020-04-01,2024-02,2024-02-29,2020-12-10,ACTUAL,2020-12-10,2020-12-10,ACTUAL,2020-12-10,,INTERVENTIONAL,,,Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial,Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: PRIME,TERMINATED,,PHASE1,2.0,ACTUAL,OHSU Knight Cancer Institute,,1.0,,Low accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,OTHER,,,,,,,2020,0.0
NCT01382745,,2011-06-24,,,2013-01-25,2011-06-24,2011-06-27,ESTIMATED,,,,,,,2013-01-25,2013-01-28,ESTIMATED,2012-01,,2012-01-31,2013-01,2013-01-31,2022-01,ESTIMATED,2022-01-31,2021-09,ESTIMATED,2021-09-30,,INTERVENTIONAL,,,Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers,A Phase II Clinical Study Using Nimotuzumab in Combination With External Beam Radiation Therapy in the Treatment of Patients With Carcinomas of the Anal Canal,TERMINATED,,PHASE2,1.0,ACTUAL,Sir Mortimer B. Davis - Jewish General Hospital,,1.0,,low recruitment,f,,,,t,,,,,,,,,,,,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,OTHER,,,,,,,2022,0.0
NCT02278718,,2014-10-27,2024-02-08,,2024-09-25,2014-10-28,2014-10-30,ESTIMATED,2024-09-25,2024-09-27,ACTUAL,,,,2024-09-25,2024-09-27,ACTUAL,2015-05,ACTUAL,2015-05-31,2024-09,2024-09-30,2022-12,ACTUAL,2022-12-31,2021-04,ACTUAL,2021-04-30,,INTERVENTIONAL,,"Overall, 153 patients were screened for enrolment (Enrolled Set). Of the 153 patients enrolled, 145 patients were randomised and included in the FAS: 72 in the NexoBrid treatment arm and 73 in the SOC treatment arm.",A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care,"A Multicenter, Multinational, Randomized, Controlled, Open Label Study, Performed in Children With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid as Compared to Standard of Care (SOC) Treatment",COMPLETED,,PHASE3,145.0,ACTUAL,MediWound Ltd,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,INDUSTRY,,,,,,,2022,1.0
NCT04334915,,2020-04-02,,,2022-12-19,2020-04-02,2020-04-06,ACTUAL,,,,,,,2022-12-19,2022-12-21,ACTUAL,2022-11-22,ESTIMATED,2022-11-22,2022-12,2022-12-31,2024-08-15,ESTIMATED,2024-08-15,2024-08-15,ESTIMATED,2024-08-15,,INTERVENTIONAL,,,Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV,"A Multicenter, Prospective, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV",WITHDRAWN,,PHASE2,0.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,Industry supporter no longer supporting the study. Protocol A5415's study will run instead.,f,,,,t,t,f,,,,,,Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH,* With whom?~  * Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses?~  * To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism will data be made available?~  * Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at: https: https://submit.mis.s-3.net/ Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.,,YES,"Individual participant data that underlie results in the publication, after deidentification.",2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,NIH,,,,,,,2024,0.0
NCT04429685,,2020-06-04,,,2024-05-20,2020-06-11,2020-06-12,ACTUAL,,,,,,,2024-05-20,2024-05-21,ACTUAL,2020-11-01,ACTUAL,2020-11-01,2024-05,2024-05-31,2021-05-28,ACTUAL,2021-05-28,2021-05-28,ACTUAL,2021-05-28,,INTERVENTIONAL,,,The Effects of Low Dose Ketamine on Cardiovascular Function,The Effects of Low Dose Ketamine on Cardiovascular Function,TERMINATED,,PHASE1,6.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,The focus of the laboratory went a different direction given extramural funding,f,,,,,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,OTHER,,,,,,,2021,0.0
NCT02303951,,2014-11-13,,,2021-01-29,2014-11-28,2014-12-01,ESTIMATED,,,,,,,2021-01-29,2021-02-03,ACTUAL,2015-01-22,ACTUAL,2015-01-22,2020-05,2020-05-31,2020-05-14,ACTUAL,2020-05-14,2020-05-14,ACTUAL,2020-05-14,,INTERVENTIONAL,NEO-VC,,Neoadjuvant Vemurafenib + Cobimetinib + Atezolizumab in Melanoma: NEO-VC,"Neoadjuvant Treatment With the Combination of Vemurafenib, Cobimetinib and Atezolizumab in Limited Metastasis of Malignant Melanoma (AJCC Stage IIIC/IV) and Integrated Biomarker Study: a Single Armed, Two Cohort, Phase II EADO Trial NEO-VC",TERMINATED,,PHASE2,47.0,ACTUAL,University Hospital Tuebingen,,1.0,,The main reason for the early termination is the low recruitment rate.,f,,,,f,,,,,,,,,,,,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,OTHER,,,,,,,2020,0.0
NCT05973747,,2023-07-13,,,2024-04-09,2023-07-25,2023-08-03,ACTUAL,,,,,,,2024-04-09,2024-04-11,ACTUAL,2023-08-19,ACTUAL,2023-08-19,2024-04,2024-04-30,2023-12-15,ACTUAL,2023-12-15,2023-12-15,ACTUAL,2023-12-15,,INTERVENTIONAL,,,Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients,Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients,COMPLETED,,EARLY_PHASE1,34.0,ACTUAL,Stanford University,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,OTHER,,,,,,,2023,1.0
NCT04320940,,2020-03-23,2023-08-30,,2023-10-25,2020-03-23,2020-03-25,ACTUAL,2023-10-25,2023-10-26,ACTUAL,,,,2023-10-25,2023-10-26,ACTUAL,2021-03-12,ACTUAL,2021-03-12,2023-10,2023-10-31,2023-02-01,ACTUAL,2023-02-01,2023-02-01,ACTUAL,2023-02-01,,INTERVENTIONAL,,,Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures,"A Randomized, Double-Blind, Controlled Study to Assess the Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures",TERMINATED,,PHASE3,4.0,ACTUAL,"NEMA Research, Inc.",,2.0,,"Insufficient participant recruitment hindered the study's progress, preventing robust data collection and compromising statistical power",f,,,,,t,f,,,,,,,,,NO,There is no plan to share IPD.,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,INDUSTRY,,,,,,,2023,0.0
NCT02995330,,2016-12-14,2022-07-07,,2024-02-09,2016-12-15,2016-12-16,ESTIMATED,2024-02-09,2024-02-13,ACTUAL,,,,2024-02-09,2024-02-13,ACTUAL,2017-02-09,ACTUAL,2017-02-09,2024-02,2024-02-29,2021-06-16,ACTUAL,2021-06-16,2021-06-16,ACTUAL,2021-06-16,,INTERVENTIONAL,,,Sex-Mismatched Allogeneic Bone Marrow Transplantation for Men With Metastatic Castration-Resistant Prostate Cancer,A Pilot Study of Sex-Mismatched Allogeneic Bone Marrow Transplantation for Men With Metastatic Castration-Resistant Prostate Cancer,TERMINATED,,PHASE1,3.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,lack of accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,OTHER,,,,,,,2021,0.0
NCT03786419,,2018-12-18,,,2021-05-11,2018-12-20,2018-12-26,ACTUAL,,,,,,,2021-05-11,2021-05-13,ACTUAL,2020-08,ESTIMATED,2020-08-31,2021-05,2021-05-31,2020-08,ESTIMATED,2020-08-31,2020-08,ESTIMATED,2020-08-31,,INTERVENTIONAL,,,A Study of Atezolizumab in Unresectable or Advaced Malignant Pleural Mesothelioma,Phase II Study to Evaluate the Efficacy and Safety of Atezolizumab in Subjects With Unresectable or Advanced Malignant Pleural Mesothelioma Who Experienced Progression on Platinum-Based Chemotherapy,WITHDRAWN,,PHASE2,0.0,ACTUAL,Health Pharma Professional Research,,1.0,,Publication of study results of ICI use in MPM as first line therapy,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,OTHER,,,,,,,2020,0.0
NCT05268497,,2022-02-25,,,2022-09-21,2022-02-25,2022-03-07,ACTUAL,,,,,,,2022-09-21,2022-09-22,ACTUAL,2022-09-01,ESTIMATED,2022-09-01,2022-09,2022-09-30,2023-06-07,ESTIMATED,2023-06-07,2023-06-07,ESTIMATED,2023-06-07,,INTERVENTIONAL,,,A Study to Assess Feasibility of Using Clinician-directed and Digital Application Supported Cognitive Behavior Therapy (CBT) in Conjunction With Esketamine in Participants With Treatment-resistant Depression,Assessment of Feasibility of Using Clinician-Directed Cognitive Behavior Therapy Supplemented by a Digital Application in Conjunction With Esketamine (SPRAVATO®) in Participants With Treatment-Resistant Depression,WITHDRAWN,,PHASE1,0.0,ACTUAL,"Janssen Research & Development, LLC",,1.0,,due to budget decision and wanting to pursue other research priorities,f,,,,f,t,f,,,f,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 22:18:30.615103,2024-10-15 22:18:30.615103,INDUSTRY,,,,,,,2023,0.0
NCT04615845,,2020-10-22,,,2022-12-29,2020-11-02,2020-11-04,ACTUAL,,,,,,,2022-12-29,2023-01-03,ACTUAL,2021-06-21,ACTUAL,2021-06-21,2022-12,2022-12-31,2022-02-15,ACTUAL,2022-02-15,2022-02-15,ACTUAL,2022-02-15,,INTERVENTIONAL,,,Safety Evaluation of Autologous Dendritic Cell Anticancer Immune Cell Therapy (Cellgram-DC-PC),"An Open Label, Single-center, Phase 1 Study to Evaluate the Safety of Cancer Immunotherapy With Autologous Dendritic Cells in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)",TERMINATED,,PHASE1,3.0,ACTUAL,"Pharmicell Co., Ltd.",,1.0,,Difficult recruitment,f,,,,f,f,f,,,,,,,,,,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,INDUSTRY,,,,,,,2022,0.0
NCT03003364,,2016-12-14,,,2020-02-13,2016-12-21,2016-12-28,ESTIMATED,,,,,,,2020-02-13,2020-02-17,ACTUAL,2016-12-27,ACTUAL,2016-12-27,2020-02,2020-02-29,2020-02-11,ACTUAL,2020-02-11,2019-07-25,ACTUAL,2019-07-25,,INTERVENTIONAL,,,Intrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury,"A Phase I/IIa, Randomized, Double-blind, Single-dose, Placebo Controlled, Two-way Crossover Clinical Trial to Assess the Safety and to Obtain Efficacy Data in Intrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury",COMPLETED,,PHASE1/PHASE2,10.0,ACTUAL,Banc de Sang i Teixits,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,OTHER,,,,,,,2020,1.0
NCT03954444,,2019-04-10,2021-04-30,,2021-06-22,2019-05-16,2019-05-17,ACTUAL,2021-06-22,2021-06-23,ACTUAL,,,,2021-06-22,2021-06-23,ACTUAL,2019-04-15,ACTUAL,2019-04-15,2021-06,2021-06-30,2020-02-27,ACTUAL,2020-02-27,2020-01-07,ACTUAL,2020-01-07,,INTERVENTIONAL,,Safety Population also defined as in the Participant Flow,A Clinical Endpoint Bioequivalence Study of Oxymetazoline Hydrochloride Cream,"A Randomized, Double Blind, Parallel Group, Three Arm, Placebo Controlled, Multi-Site Therapeutic Equivalence Study With Clinical End-points Comparing Test Product Oxymetazoline Hydrochloride Cream, 1% to Reference Product RHOFADETM Cream, 1% in the Treatment of Moderate to Severe Persistent Facial Erythema of Rosacea",COMPLETED,,PHASE3,1105.0,ACTUAL,Actavis Inc.,,3.0,,,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 08:24:34.552235,2024-10-16 08:24:34.552235,INDUSTRY,,,,,,,2020,1.0
NCT05601882,,2022-10-31,,,2024-08-20,2022-10-31,2022-11-01,ACTUAL,,,,,,,2024-08-20,2024-08-21,ACTUAL,2022-11-28,ACTUAL,2022-11-28,2024-08,2024-08-31,2024-08-08,ACTUAL,2024-08-08,2024-03-19,ACTUAL,2024-03-19,,INTERVENTIONAL,Level Up,,A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis,"A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects With Moderate to Severe Atopic Dermatitis (Level-Up)",COMPLETED,,PHASE3,926.0,ACTUAL,AbbVie,,2.0,,,f,,,,f,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-14 21:22:01.437344,2024-10-14 21:22:01.437344,INDUSTRY,,,,,,,2024,1.0
NCT05233410,,2022-02-01,,,2022-11-07,2022-02-01,2022-02-10,ACTUAL,,,,,,,2022-11-07,2022-11-10,ACTUAL,2023-01-31,ESTIMATED,2023-01-31,2022-11,2022-11-30,2024-09-22,ESTIMATED,2024-09-22,2024-04-25,ESTIMATED,2024-04-25,,INTERVENTIONAL,TRuE-CHE2,,Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2,"Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2 (TRuE-CHE2): A Phase 3, Double-Blind, Randomized, 16-Week, Vehicle Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Open-Label Extension Period in Adults With Chronic Hand Eczema",WITHDRAWN,,PHASE3,0.0,ACTUAL,Incyte Corporation,,2.0,,Business decision; no safety concerns,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,INDUSTRY,,,,,,,2024,0.0
NCT02551679,,2015-09-14,2023-09-09,,2023-11-22,2015-09-14,2015-09-16,ESTIMATED,2023-10-30,2023-11-18,ACTUAL,,,,2023-11-22,2023-11-28,ACTUAL,2014-08,ACTUAL,2014-08-31,2023-11,2023-11-30,2021-04,ACTUAL,2021-04-30,2020-04,ACTUAL,2020-04-30,,INTERVENTIONAL,,,ACP-01 in Patients With Critical Limb Ischemia,A Randomized Double Blind Placebo Controlled Clinical Study to Assess Blood-Derived Autologous Angiogenic Cell Precursor Therapy in Patients With Critical Limb Ischemia (ACP-CLI),COMPLETED,,PHASE2,67.0,ACTUAL,Hemostemix,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 17:32:19.226396,2024-10-16 17:32:19.226396,INDUSTRY,,,,,,,2021,1.0
NCT03277261,,2017-09-07,2021-11-05,2021-05-11,2021-11-05,2017-09-07,2017-09-11,ACTUAL,2021-11-05,2021-12-06,ACTUAL,2021-05-11,2021-05-20,ACTUAL,2021-11-05,2021-12-06,ACTUAL,2017-09-19,ACTUAL,2017-09-19,2021-11,2021-11-30,2020-11-06,ACTUAL,2020-11-06,2020-07-23,ACTUAL,2020-07-23,,INTERVENTIONAL,ULTIMATE 1,Intention-to-Treat (ITT) population consisted of all randomized participants.,Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 ),Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY),COMPLETED,,PHASE3,549.0,ACTUAL,"TG Therapeutics, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,Data will be shared after study completion via publication.,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,INDUSTRY,,,,,,,2020,1.0
NCT04473651,,2020-07-13,,,2021-11-30,2020-07-13,2020-07-16,ACTUAL,,,,,,,2021-11-30,2021-12-14,ACTUAL,2020-07-09,ACTUAL,2020-07-09,2021-11,2021-11-30,2021-11-10,ACTUAL,2021-11-10,2021-11-10,ACTUAL,2021-11-10,,INTERVENTIONAL,,,Safety and Tolerability of Lu AG06479 in Healthy Young Men,"Interventional, Randomized, Double-blind, Placebo-controlled, Sequential-group, Single-ascending Oral Dose Study Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06479 and Open-label Cross-over Study to Investigate Intra-subject Variability and Effect of Food in Healthy Young Men",TERMINATED,,PHASE1,46.0,ACTUAL,H. Lundbeck A/S,,2.0,,The study was terminated for strategic reasons.,f,,,,,t,f,,,,,,,,,,,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,INDUSTRY,,,,,,,2021,0.0
NCT04138875,,2019-10-23,,,2022-06-21,2019-10-23,2019-10-25,ACTUAL,,,,,,,2022-06-21,2022-06-23,ACTUAL,2022-01,ESTIMATED,2022-01-31,2022-06,2022-06-30,2023-12,ESTIMATED,2023-12-31,2023-09,ESTIMATED,2023-09-30,,INTERVENTIONAL,,,"A Risk Stratified Sequential Treatment With Rituximab, Brentuximab Vedotin and Bendamustine (RBvB)","A Phase II Multicenter Open Label Risk Stratified Sequential Treatment With Rituximab, Brentuximab Vedotin and Bendamustine (RBvB) in Patients Newly Diagnosed.",WITHDRAWN,,PHASE2,0.0,ACTUAL,Yale University,,2.0,,Lack of funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,OTHER,,,,,,,2023,0.0
NCT03060772,,2017-02-19,,2022-01-20,2023-02-13,2017-02-19,2017-02-23,ACTUAL,,,,2022-01-20,2022-01-25,ACTUAL,2023-02-13,2023-02-14,ACTUAL,2018-01-03,ACTUAL,2018-01-03,2023-02,2023-02-28,2020-01-28,ACTUAL,2020-01-28,2020-01-28,ACTUAL,2020-01-28,,INTERVENTIONAL,APPEAL,,A Study of Pleiotropic Pioglitazone Effects on the Alcoholic Lung (APPEAL Study),A Study of Pleiotropic Pioglitazone Effects on the Alcoholic Lung (APPEAL Study),TERMINATED,,PHASE2,50.0,ACTUAL,Emory University,,3.0,,"Study was suspended in 2020 due to COVID-19 pandemic as a result of recruitment challenges and the inability to conduct all study procedures (e.g., bronchoscopy) per protocol. In late 2021 the decision was made to not re-open the study.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,OTHER,,,,,,,2020,0.0
NCT03239470,,2017-08-02,2021-10-22,,2024-02-14,2017-08-02,2017-08-04,ACTUAL,2021-10-22,2021-11-22,ACTUAL,,,,2024-02-14,2024-02-15,ACTUAL,2017-10-10,ACTUAL,2017-10-10,2024-02,2024-02-29,2023-01-09,ACTUAL,2023-01-09,2020-12-10,ACTUAL,2020-12-10,,INTERVENTIONAL,,"Participants who donated peripheral blood to be processed in a lab that expanded regulatory T cells (Tregs) that, after two weeks, received a single infusion of ex vivo expanded autologous CD4+CD127lo/-CD25+ polyclonal Tregs (PolyTregs). Target cell dose was 1 x 10\^8 PolyTregs.",Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus,"A Phase I, Open-Label, Multicenter Trial Exploring the Safety and Tolerability of Autologous Polyclonal Regulatory T Cell Therapy in Adults With Active Pemphigus (APG01)",TERMINATED,,PHASE1,5.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),"Enrollment was stopped early, on May 1, 2020, due to:~* Lack of recruitment,~* Ongoing and new feasibility issues, including the recent approval of rituximab for treatment of pemphigus, and~* The impact of the coronavirus infectious disease 19 (COVID-19) pandemic.~No participants were enrolled in Cohort 2.",2.0,,"Lack of recruitment, ongoing and new feasibility issues, and the impact of the coronavirus infectious disease 19 (COVID-19) pandemic",f,,,,t,t,f,,,,,,"On average, within 24 months after database lock for the trial.",Open access.,https://www.immport.org/home,YES,"The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.",2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,NIH,,,,,,,2023,0.0
NCT04519658,,2020-08-17,2023-06-07,,2023-07-10,2020-08-17,2020-08-20,ACTUAL,2023-06-07,2023-06-28,ACTUAL,,,,2023-07-10,2023-07-24,ACTUAL,2020-10-12,ACTUAL,2020-10-12,2023-07,2023-07-31,2022-06-14,ACTUAL,2022-06-14,2022-06-14,ACTUAL,2022-06-14,,INTERVENTIONAL,BrigHTN,,A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN),"A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 12 Weeks of Treatment in Patients With Treatment-Resistant Hypertension (rHTN)",COMPLETED,,PHASE2,275.0,ACTUAL,"CinCor Pharma, Inc.",,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,INDUSTRY,,,,,,,2022,1.0
NCT02882321,,2016-08-24,2023-04-11,,2023-06-14,2016-08-24,2016-08-29,ESTIMATED,2023-06-14,2023-06-15,ACTUAL,,,,2023-06-14,2023-06-15,ACTUAL,2016-09-29,ACTUAL,2016-09-29,2023-06,2023-06-30,2022-04-15,ACTUAL,2022-04-15,2022-04-15,ACTUAL,2022-04-15,,INTERVENTIONAL,,,Oxidative Phosphorylation Inhibitor IACS-010759 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia,Phase 1 Study of IACS-010759 in Subjects With Relapsed or Refractory AML,TERMINATED,,PHASE1,17.0,ACTUAL,M.D. Anderson Cancer Center,,4.0,,The study was terminated by the Sponsor for apparent lack of effectiveness.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,OTHER,,,,,,,2022,0.0
NCT04237584,,2020-01-15,2022-05-23,,2022-09-09,2020-01-21,2020-01-23,ACTUAL,2022-09-09,2022-10-07,ACTUAL,,,,2022-09-09,2022-10-07,ACTUAL,2020-06-30,ACTUAL,2020-06-30,2022-09,2022-09-30,2022-03-07,ACTUAL,2022-03-07,2022-03-07,ACTUAL,2022-03-07,,INTERVENTIONAL,ESCALATE,,A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients,"ESCALATE, A Phase III Randomized Study Comparing Enzalutamide or Darolutamide With Radium-223 vs Enzalutamide or Darolutamide With Placebo and the Effect Upon Symptomatic Skeletal Event-Free Survival for mCRPC Patients",TERMINATED,,PHASE3,23.0,ACTUAL,MANA RBM,ESCALATE (PC18-1005) was terminated early due to enrollment challenges.,6.0,,"The study was stopped due to insurmountable enrollment challenges affecting trial accrual, resulting from the rapidly evolving treatment options for advanced prostate cancer.",f,,,,f,t,f,,,,,,,,,,,2024-10-14 21:22:01.437344,2024-10-14 21:22:01.437344,OTHER,,,,,,,2022,0.0
NCT04091646,,2019-09-13,2023-06-12,2021-06-18,2023-06-12,2019-09-13,2019-09-17,ACTUAL,2023-06-12,2023-07-03,ACTUAL,2021-06-18,2021-06-23,ACTUAL,2023-06-12,2023-07-03,ACTUAL,2019-12-04,ACTUAL,2019-12-04,2023-06,2023-06-30,2020-08-21,ACTUAL,2020-08-21,2020-08-18,ACTUAL,2020-08-18,,INTERVENTIONAL,,,Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis,"A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis",COMPLETED,,PHASE2,226.0,ACTUAL,"Arcutis Biotherapeutics, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 11:26:51.247712,2024-10-15 11:26:51.247712,INDUSTRY,,,,,,,2020,1.0
NCT05126303,,2021-11-08,2024-03-20,,2024-05-15,2021-11-08,2021-11-19,ACTUAL,2024-05-15,2024-05-16,ACTUAL,,,,2024-05-15,2024-05-16,ACTUAL,2022-03-31,ACTUAL,2022-03-31,2024-05,2024-05-31,2023-07-12,ACTUAL,2023-07-12,2023-04-15,ACTUAL,2023-04-15,,INTERVENTIONAL,AKITA,All dosed,Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery,"A Phase 2, Randomized, Placebo-Controlled, Double-Blind, Adaptive, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery",TERMINATED,,PHASE2,177.0,ACTUAL,Guard Therapeutics AB,"Study was stopped prematurely for futility following Data Monitoring Committee (DMC) recommendation.~The early termination lead to smaller numbers than planned, and that not all outcome measures were analyzed.",2.0,,Enrollment discontinued following DMC recommendation based on futility with regards to primary endpoint,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-14 21:22:01.437344,2024-10-14 21:22:01.437344,INDUSTRY,,,,,,,2023,0.0
NCT02501434,,2015-07-13,,,2022-02-17,2015-07-15,2015-07-17,ESTIMATED,,,,,,,2022-02-17,2022-03-04,ACTUAL,2016-04,ACTUAL,2016-04-30,2022-02,2022-02-28,2024-01-01,ESTIMATED,2024-01-01,2023-01,ESTIMATED,2023-01-31,,INTERVENTIONAL,ASTROH,,Aneurysmal Subarachnoid Hemorrhage Trial RandOmizing Heparin,A Blind-adjudication Multi-center Phase II Randomized Clinical Trial of Continuous Low-dose Intravenous Heparin Therapy in Coiled Low-grade Aneurysmal Subarachnoid Hemorrhage Patients With Significant Hemorrhage Burden,SUSPENDED,,PHASE2,88.0,ESTIMATED,Indiana University,,2.0,,,f,,,,t,t,,,,,,,,,,NO,There is no plan to share data other than through publication or requests to Robert James by other investigators.,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,OTHER,,,,,,,2024,0.0
NCT03022617,,2017-01-12,2021-06-30,,2024-05-07,2017-01-12,2017-01-16,ESTIMATED,2021-06-30,2021-07-20,ACTUAL,,,,2024-05-07,2024-06-06,ACTUAL,2017-01,,2017-01-31,2024-05,2024-05-31,2022-09-29,ACTUAL,2022-09-29,2020-09-01,ACTUAL,2020-09-01,,INTERVENTIONAL,,,A Study Evaluating the Efficacy and Tolerability of Oral Apremilast for the Treatment of Nail Psoriasis,An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Oral Apremilast for the Treatment of Nail Psoriasis,COMPLETED,,PHASE4,12.0,ACTUAL,University of Alabama at Birmingham,,1.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,OTHER,,,,,,,2022,1.0
NCT04419688,,2020-06-03,,,2023-01-19,2020-06-03,2020-06-05,ACTUAL,,,,,,,2023-01-19,2023-01-23,ACTUAL,2020-05-26,ACTUAL,2020-05-26,2023-01,2023-01-31,2022-12-23,ACTUAL,2022-12-23,2022-12-23,ACTUAL,2022-12-23,,INTERVENTIONAL,,,"A First in Human Study of STT-5058, an Antibody That Binds ApoC3","A Double-blind, Randomised, Placebo-controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple-ascending Doses of Intravenously Administered STT-5058 in Otherwise Healthy Subjects With Elevated Triglyceride Levels and Single-ascending and Multiple Doses of Subcutaneously Administered STT-5058 in Otherwise Healthy Subjects With Elevated Triglyceride Levels and Patient Volunteers With Hypertriglyceridemia.",TERMINATED,,PHASE1,93.0,ACTUAL,Staten Biotechnology BV,,2.0,,recruitment failure,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,INDUSTRY,,,,,,,2022,0.0
NCT04635774,,2020-11-06,,,2024-08-19,2020-11-13,2020-11-19,ACTUAL,,,,,,,2024-08-19,2024-08-21,ACTUAL,2021-02-25,ACTUAL,2021-02-25,2024-08,2024-08-31,2023-11-14,ACTUAL,2023-11-14,2023-11-14,ACTUAL,2023-11-14,,INTERVENTIONAL,PODS,,Post Operative Delirium Study,Intranasal Insulin and Neurocognitive Function,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Kansas Medical Center,,2.0,,Participants were unable to be enrolled,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-14 21:22:01.437344,2024-10-14 21:22:01.437344,OTHER,,,,,,,2023,0.0
NCT03354897,,2017-09-28,,,2023-09-22,2017-11-27,2017-11-28,ACTUAL,,,,,,,2023-09-22,2023-09-25,ACTUAL,2017-04-05,ACTUAL,2017-04-05,2023-09,2023-09-30,2021-10-30,ACTUAL,2021-10-30,2021-10-30,ACTUAL,2021-10-30,,INTERVENTIONAL,UMOD,,Clinical Study of UMOD NKCC2 Interaction on Salt-sensitivity in Hypertension,Clinical Study of UMOD NKCC2 Interaction on Salt-sensitivity in Hypertension,COMPLETED,,PHASE4,228.0,ACTUAL,NHS Greater Glasgow and Clyde,,1.0,,,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,OTHER,,,,,,,2021,1.0
NCT04476030,,2020-07-15,2023-08-25,2022-11-30,2023-12-20,2020-07-15,2020-07-17,ACTUAL,2023-10-13,2023-11-07,ACTUAL,,2023-11-07,ACTUAL,2023-12-20,2023-12-22,ACTUAL,2020-11-09,ACTUAL,2020-11-09,2023-12,2023-12-31,2021-12-22,ACTUAL,2021-12-22,2021-10-25,ACTUAL,2021-10-25,,INTERVENTIONAL,,Safety Set included all participants who administered blinded IP.,A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder,"A Phase 3, Randomized, Double-Blind Study Comparing the Efficacy and Safety of SAGE-217 Plus an Antidepressant Versus Placebo Plus an Antidepressant in Adults With Major Depressive Disorder",COMPLETED,,PHASE3,440.0,ACTUAL,Biogen,,2.0,,,f,,,,f,t,f,,,f,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,INDUSTRY,,,,,,,2021,1.0
NCT04347486,,2020-04-13,,,2022-02-08,2020-04-13,2020-04-15,ACTUAL,,,,,,,2022-02-08,2022-02-10,ACTUAL,2020-04-29,ACTUAL,2020-04-29,2022-02,2022-02-28,2021-12-07,ACTUAL,2021-12-07,2021-12-07,ACTUAL,2021-12-07,,INTERVENTIONAL,,,Pharmacokinetic-pharmacodynamic Analysis of Sugammadex for Conventional Reversal in Children,Pharmacokinetic-pharmacodynamic Analysis of Conventional Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children,COMPLETED,,PHASE2,32.0,ACTUAL,Seoul National University Hospital,,4.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,OTHER,,,,,,,2021,1.0
NCT04551898,,2020-09-10,2022-02-25,,2022-03-15,2020-09-15,2020-09-16,ACTUAL,2022-03-15,2022-03-17,ACTUAL,,,,2022-03-15,2022-03-17,ACTUAL,2020-12-02,ACTUAL,2020-12-02,2022-03,2022-03-31,2021-05-25,ACTUAL,2021-05-25,2021-05-25,ACTUAL,2021-05-25,,INTERVENTIONAL,,Intent to treat (ITT) analysis set includes all randomized participants.,Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19),"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SARS-CoV-2 Neutralizing Antibody BGB-DXP593 in Patients With Mild-to-Moderate COVID-19",COMPLETED,,PHASE2,181.0,ACTUAL,BeiGene,,4.0,,,,,,,t,t,f,,,,,,,,,YES,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,INDUSTRY,,,,,,,2021,1.0
NCT04348513,,2020-04-09,,,2021-09-16,2020-04-14,2020-04-16,ACTUAL,,,,,,,2021-09-16,2021-09-23,ACTUAL,2020-05-29,ACTUAL,2020-05-29,2021-09,2021-09-30,2021-04-19,ACTUAL,2021-04-19,2021-04-19,ACTUAL,2021-04-19,,INTERVENTIONAL,Thy-Support,,Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection,Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection (Thy-Support),TERMINATED,,PHASE2,5.0,ACTUAL,Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.,,2.0,,Due to specific inclusion criteria no more subjects could be enrolled.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,INDUSTRY,,,,,,,2021,0.0
NCT03386214,,2017-12-21,,,2021-12-16,2017-12-21,2017-12-29,ACTUAL,,,,,,,2021-12-16,2022-01-06,ACTUAL,2018-04-23,ACTUAL,2018-04-23,2021-12,2021-12-31,2021-10-04,ACTUAL,2021-10-04,2021-09-12,ACTUAL,2021-09-12,,INTERVENTIONAL,,,Pevonedistat in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis,Pevonedistat in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis,TERMINATED,,PHASE1,8.0,ACTUAL,Washington University School of Medicine,,3.0,,Sponsor stopped development of pevonedistat,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,OTHER,,,,,,,2021,0.0
NCT03395314,,2017-12-22,2023-05-05,,2023-05-31,2018-01-03,2018-01-10,ACTUAL,2023-05-31,2023-06-26,ACTUAL,,,,2023-05-31,2023-06-26,ACTUAL,2018-02-15,ACTUAL,2018-02-15,2023-05,2023-05-31,2022-05-06,ACTUAL,2022-05-06,2022-05-06,ACTUAL,2022-05-06,,INTERVENTIONAL,,,Ketamine in Borderline Personality Disorder,A Randomized Active Placebo Controlled Trial of Ketamine in Borderline Personality Disorder,TERMINATED,,PHASE2,22.0,ACTUAL,Yale University,,2.0,,assessment of project in wake of covid-19 related interruptions,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,OTHER,,,,,,,2022,0.0
NCT02629419,,2015-11-16,2024-05-10,,2024-07-10,2015-12-10,2015-12-14,ESTIMATED,2024-05-10,2024-06-07,ACTUAL,,,,2024-07-10,2024-08-07,ACTUAL,2016-09-27,ACTUAL,2016-09-27,2024-07,2024-07-31,2022-08-06,ACTUAL,2022-08-06,2021-11-09,ACTUAL,2021-11-09,,INTERVENTIONAL,CAMB,,CAMB/MAT2203 in Patients With Mucocutaneous Candidiasis,"A Phase 2a Efficacy, Safety, Tolerability, and PK Study of Encochleated Amphotericin B (CAMB/MAT2203) in Patients With Mucocutaneous Candidiasis Who Are Refractory or Intolerant to Standard Non-Intravenous Therapies",COMPLETED,,PHASE2,4.0,ACTUAL,"Matinas BioPharma Nanotechnologies, Inc.",Did not reach target number of participants (small sample size). All participants were female and Caucasian.,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,INDUSTRY,,,,,,,2022,1.0
NCT03176784,,2017-06-01,2021-05-04,,2023-01-19,2017-06-01,2017-06-06,ACTUAL,2021-05-27,2021-05-28,ACTUAL,,,,2023-01-19,2023-01-23,ACTUAL,2017-11-11,ACTUAL,2017-11-11,2023-01,2023-01-31,2020-07-09,ACTUAL,2020-07-09,2020-07-09,ACTUAL,2020-07-09,,INTERVENTIONAL,QUITS,,UW Quitting Using Intensive Treatment Study (QUITS),UW Quitting Using Intensive Treatment Study,COMPLETED,,PHASE4,1251.0,ACTUAL,"University of Wisconsin, Madison",,4.0,,,f,,,,t,t,f,,,f,,,12 months after publication of the primary outcome paper.,Prior written data request to the PI.,,YES,De-identified data set will be posted by UW-CTRI in accord with NHLBI policies,2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,OTHER,,,,,,,2020,1.0
NCT03847922,,2019-02-18,,,2020-08-18,2019-02-19,2019-02-20,ACTUAL,,,,,,,2020-08-18,2020-08-20,ACTUAL,2019-02-15,ACTUAL,2019-02-15,2019-02,2019-02-28,2020-07-23,ACTUAL,2020-07-23,2020-07-23,ACTUAL,2020-07-23,,INTERVENTIONAL,,,Nitrous Oxide for Analgesia During Office Urethral Bulking,"Nitrous Oxide for Analgesia During Office Urethral Bulking: a Randomized, Controlled Trial",TERMINATED,,PHASE4,2.0,ACTUAL,Baylor Research Institute,,2.0,,"Due to staffing changes in the hospital, we will be unable to complete this study for the requested 84 subjects. As such, we have decided to close this study.",f,,,,f,t,f,,,t,,,,,,NO,"No IPD will be shared with other researchers. Once all data is collected for a specific patient, it will be deidentified and entered in a spread sheet to be used for this study only.",2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,OTHER,,,,,,,2020,0.0
NCT03723915,,2018-10-26,2020-11-24,,2022-09-06,2018-10-26,2018-10-30,ACTUAL,2020-12-29,2021-01-20,ACTUAL,,,,2022-09-06,2022-10-05,ACTUAL,2018-11-14,ACTUAL,2018-11-14,2022-09,2022-09-30,2021-04-24,ACTUAL,2021-04-24,2019-12-19,ACTUAL,2019-12-19,,INTERVENTIONAL,,"Only patients who were treated on study were included. 2 patients were screen fails, and 2 patients became ineligible for treatment and did not receive study drug--these patients were not included here.",Pembrolizumab and Pelareorep in Treating Patients With Advanced Pancreatic Cancer,A Phase 2 Study of Pembrolizumab in Combination With Pelareorep in Patients With Advanced Pancreatic Adenocarcinoma,TERMINATED,,PHASE2,17.0,ACTUAL,Northwestern University,The total accrual goal of 34 patients was not met. Stage 1 of the study did not meet the interim analysis criteria to move onto Stage 2 of the Simon 2 stage design.,1.0,,The total accrual goal of 34 patients was not met. Stage 1 of the study did not meet the interim analysis criteria to move onto Stage 2 of the Simon 2 stage design.,,,,,t,t,f,,,f,,,,,,,,2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,OTHER,,,,,,,2021,0.0
NCT03094832,,2017-03-17,2023-03-06,,2023-04-11,2017-03-28,2017-03-29,ACTUAL,2023-03-06,2023-03-31,ACTUAL,,,,2023-04-11,2023-04-13,ACTUAL,2017-05-16,ACTUAL,2017-05-16,2023-04,2023-04-30,2022-04-11,ACTUAL,2022-04-11,2022-04-11,ACTUAL,2022-04-11,,INTERVENTIONAL,MOSAIC,,Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002),A Phase 1/2 Study of ARQ 092 (Miransertib) in Subjects With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome,TERMINATED,,PHASE1/PHASE2,50.0,ACTUAL,"ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)",Early termination due to business reasons,5.0,,Early termination due to business reasons,t,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 08:30:55.373207,2024-10-16 08:30:55.373207,INDUSTRY,,NCT03317366,NO_LONGER_AVAILABLE,,,,2022,0.0
NCT03644706,,2018-08-22,,,2024-03-21,2018-08-22,2018-08-23,ACTUAL,,,,,,,2024-03-21,2024-03-22,ACTUAL,2021-09-20,ACTUAL,2021-09-20,2024-03,2024-03-31,2023-12-20,ACTUAL,2023-12-20,2023-12-20,ACTUAL,2023-12-20,,INTERVENTIONAL,,,Study Evaluating Subjects With Distal Renal Tubular Acidosis,"A Phase 3 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Withdrawal Study Evaluating ADV7103 In Pediatric and Adult Subjects With Distal Renal Tubular Acidosis (dRTA)",TERMINATED,,PHASE3,3.0,ACTUAL,Advicenne Pharma,,2.0,,Research operation issues,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,INDUSTRY,,,,,,,2023,0.0
NCT03419897,,2018-01-29,2023-07-03,2022-06-24,2023-07-03,2018-02-01,2018-02-05,ACTUAL,2023-07-03,2023-07-27,ACTUAL,2022-06-24,2022-06-28,ACTUAL,2023-07-03,2023-07-27,ACTUAL,2018-04-09,ACTUAL,2018-04-09,2023-07,2023-07-31,2022-07-06,ACTUAL,2022-07-06,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,,,Study of BGB-A317 in Participants With Previously Treated Unresectable HCC,"A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma",COMPLETED,,PHASE2,249.0,ACTUAL,BeiGene,,1.0,,,,,,,t,t,f,,,,,,,,,YES,,2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,INDUSTRY,,,,,,,2022,1.0
NCT02995733,,2016-11-09,2022-08-31,,2022-12-21,2016-12-15,2016-12-16,ESTIMATED,2022-12-21,2023-01-19,ACTUAL,,,,2022-12-21,2023-01-19,ACTUAL,2017-11-27,ACTUAL,2017-11-27,2022-12,2022-12-31,2021-04-30,ACTUAL,2021-04-30,2021-04-30,ACTUAL,2021-04-30,,INTERVENTIONAL,PREPARE,19 participants were dropped from analysis due to the site closure. They were not followed and not included in any analyses.,Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief,Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations,COMPLETED,,PHASE4,1220.0,ACTUAL,Brigham and Women's Hospital,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,OTHER,,,,,,,2021,1.0
NCT03346681,,2017-11-07,,,2021-03-25,2017-11-14,2017-11-17,ACTUAL,,,,,,,2021-03-25,2021-03-30,ACTUAL,2018-02-01,ACTUAL,2018-02-01,2021-03,2021-03-31,2021-01-30,ACTUAL,2021-01-30,2021-01-30,ACTUAL,2021-01-30,,INTERVENTIONAL,NARDS,,N-Acetyl-cysteine in Early Acute Respiratory Distress Syndrome,N-Acetyl-cysteine in Early Acute Respiratory Distress Syndrome,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Prisma Health-Midlands,,2.0,,no patients enrolled,f,,,,,t,f,,,t,,,,,,NO,,2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,OTHER,,,,,,,2021,0.0
NCT04060407,,2019-08-15,,,2021-05-27,2019-08-15,2019-08-19,ACTUAL,,,,,,,2021-05-27,2021-06-01,ACTUAL,2021-06-15,ESTIMATED,2021-06-15,2021-05,2021-05-31,2023-12-30,ESTIMATED,2023-12-30,2022-12-30,ESTIMATED,2022-12-30,,INTERVENTIONAL,CINDI,,CD24Fc With Ipilimumab and Nivolumab to Decrease irAE (CINDI),Phase Ib/II Study Combining CD24Fc With Checkpoint Inhibitors for Patients With Metastatic Melanoma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)",,1.0,,Business Reasons,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,INDUSTRY,,,,,,,2023,0.0
NCT04608266,,2020-10-28,,,2022-01-27,2020-10-28,2020-10-29,ACTUAL,,,,,,,2022-01-27,2022-02-10,ACTUAL,2020-12-03,ACTUAL,2020-12-03,2020-10,2020-10-31,2021-12-02,ACTUAL,2021-12-02,2021-09-27,ACTUAL,2021-09-27,,INTERVENTIONAL,CAMOVID,,CAMOVID : Evaluation of Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients,A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients (CAMOVID),TERMINATED,,PHASE3,70.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,Scientific committee decision due SARS-CoV2 pandemic evolution with a decrease in inclusions and widespread distribution of vaccines,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,OTHER,,,,,,,2021,0.0
NCT03682367,,2018-09-21,2021-06-03,,2021-07-08,2018-09-21,2018-09-24,ACTUAL,2021-07-08,2021-07-09,ACTUAL,,,,2021-07-08,2021-07-09,ACTUAL,2018-12-01,ACTUAL,2018-12-01,2021-07,2021-07-31,2020-04-06,ACTUAL,2020-04-06,2020-04-01,ACTUAL,2020-04-01,,INTERVENTIONAL,,,Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery,Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery: A Randomized Controlled Trial,TERMINATED,,PHASE3,8.0,ACTUAL,"University of California, Davis",Early study termination was decided after several technical issues regarding study logistics and patient non-compliance lead to unreliable and uninterpretable data.,2.0,,Poor Recruitment,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-14 21:22:01.437344,2024-10-14 21:22:01.437344,OTHER,,,,,,,2020,0.0
NCT05299580,,2022-02-23,,,2023-09-12,2022-03-18,2022-03-29,ACTUAL,,,,,,,2023-09-12,2023-09-14,ACTUAL,2021-02-18,ACTUAL,2021-02-18,2023-09,2023-09-30,2023-03-30,ACTUAL,2023-03-30,2023-03-30,ACTUAL,2023-03-30,,INTERVENTIONAL,,,"Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II, Open Label, Multicentre Study - (Bioliquid TAILOR Study - BIOTAILOR)","Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II, Open Label, Multicentre Study - (Bioliquid TAILOR Study - BIOTAILOR)",WITHDRAWN,,PHASE2,0.0,ACTUAL,Fondazione Melanoma Onlus,,1.0,,lack of enrollment,f,,,,f,f,f,,,,,,,,,,,2024-10-14 21:22:01.437344,2024-10-14 21:22:01.437344,OTHER,,,,,,,2023,0.0
NCT02720185,,2016-03-21,2022-01-31,2021-10-18,2022-06-02,2016-03-21,2016-03-25,ESTIMATED,2022-01-31,2022-02-25,ACTUAL,2021-10-18,2021-10-21,ACTUAL,2022-06-02,2022-06-03,ACTUAL,2017-05-03,ACTUAL,2017-05-03,2022-06,2022-06-30,2022-02-08,ACTUAL,2022-02-08,2020-07-02,ACTUAL,2020-07-02,,INTERVENTIONAL,,,Window of Opportunity Trial of Dasatinib in Operable Triple Negative Breast Cancers With nEGFR,Window of Opportunity Study of Dasatinib in Operable Triple Negative Breast Cancers With Nuclear Epidermal Growth Factor Receptor (nEGFR),TERMINATED,,PHASE2,5.0,ACTUAL,"University of Wisconsin, Madison","Statistical analyses were not completed for this study as it was not powered for meaningful results. Study was terminated early due to pandemic related enrollment issues, participants moved on to other therapies compromising intervention-relevant long term AE follow up.",1.0,,Study terminated early due to COVID-19 related slow enrollment and funding,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,OTHER,,,,,,,2022,0.0
NCT03431480,,2018-01-30,,,2022-07-19,2018-02-06,2018-02-13,ACTUAL,,,,,,,2022-07-19,2022-07-22,ACTUAL,2018-02-16,ACTUAL,2018-02-16,2022-07,2022-07-31,2022-06-30,ACTUAL,2022-06-30,2021-11-01,ACTUAL,2021-11-01,,INTERVENTIONAL,,,Safety of Autologous Cord Blood Cells in HLHS Patients During Norwood Heart Surgery,Safety Study of Autologous Cord Blood Stem Cell Treatment in Hypoplastic Left Heart Syndrome Patients Undergoing the Norwood Heart Operation,COMPLETED,,PHASE1,10.0,ACTUAL,Murdoch Childrens Research Institute,,1.0,,,f,,,,t,f,f,,,f,,,,,,UNDECIDED,IPD may be available following study publication and discussion between CIs and other researchers regarding future multicentre studies.,2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,OTHER,,,,,,,2022,1.0
NCT02382406,,2015-02-24,2022-07-07,,2023-05-19,2015-03-02,2015-03-06,ESTIMATED,2022-09-16,2022-10-14,ACTUAL,,,,2023-05-19,2023-05-23,ACTUAL,2015-06-04,ACTUAL,2015-06-04,2022-09,2022-09-30,2022-04-14,ACTUAL,2022-04-14,2022-04-14,ACTUAL,2022-04-14,,INTERVENTIONAL,,"No subjects had been enrolled to Phase I, Cohort 2.",Carboplatin/Nab-Paclitaxel and Pembrolizumab in NSCLC,A Phase I/II Study of Carboplatin/Nab-Paclitaxel and Pembrolizumab for Patients With Advanced Non-Small Cell Lung Cancer (NSCLC),TERMINATED,,PHASE1/PHASE2,46.0,ACTUAL,Hoosier Cancer Research Network,,2.0,,The study was completed. It was fully accrued.,f,,,,t,,,,,,,,,,,NO,,2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,OTHER,,,,,,,2022,0.0
NCT05080842,,2021-09-22,,,2024-04-09,2021-10-04,2021-10-18,ACTUAL,,,,,,,2024-04-09,2024-04-11,ACTUAL,2021-11-12,ACTUAL,2021-11-12,2024-04,2024-04-30,2024-04-04,ACTUAL,2024-04-04,2024-04-04,ACTUAL,2024-04-04,,INTERVENTIONAL,,,A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer,"A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of AC682 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer",TERMINATED,,PHASE1,21.0,ACTUAL,Accutar Biotechnology Inc,,1.0,,Voluntarily terminate the study since the sponsor's development strategy was adjusted.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,INDUSTRY,,,,,,,2024,0.0
NCT04296396,,2020-03-03,2023-04-10,,2023-09-06,2020-03-04,2020-03-05,ACTUAL,2023-09-06,2023-10-03,ACTUAL,,,,2023-09-06,2023-10-03,ACTUAL,2020-09-21,ACTUAL,2020-09-21,2023-09,2023-09-30,2022-07-08,ACTUAL,2022-07-08,2022-04-07,ACTUAL,2022-04-07,,INTERVENTIONAL,PACT,Baseline data were collected once for the one participant who re-enrolled,Opioid Prescription After Cesarean Trial,Prescription After Cesarean Trial,COMPLETED,,PHASE3,5521.0,ACTUAL,The George Washington University Biostatistics Center,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,The dataset will be shared per NIH policy after the completion and publication of the main analyses. Data will be available through the NICHD Data and Specimen Hub.,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,OTHER,,,,,,,2022,1.0
NCT01825369,,2013-03-28,,,2020-05-04,2013-04-02,2013-04-05,ESTIMATED,,,,,,,2020-05-04,2020-05-06,ACTUAL,2014-12,ACTUAL,2014-12-31,2020-05,2020-05-31,2020-07,ESTIMATED,2020-07-31,2020-07,ESTIMATED,2020-07-31,,INTERVENTIONAL,L-carn,,Aberrations in Carnitine Homeostasis in Congenital Heart Disease With Increased Pulmonary Blood Flow,Phase 1 Study of the Safety and Pharmacokinetics of Perioperative IV L-carnitine Administration in Patients With Congenital Heart Disease With Increased Pulmonary Blood Flow,WITHDRAWN,,PHASE1,0.0,ACTUAL,"University of California, San Francisco",,1.0,,Changes to cardiac surgery program,f,,,,t,,,,,,,,,,,,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,OTHER,,,,,,,2020,0.0
NCT04532801,,2020-08-23,,,2024-07-30,2020-08-27,2020-08-31,ACTUAL,,,,,,,2024-07-30,2024-08-01,ACTUAL,2019-09-01,ACTUAL,2019-09-01,2024-07,2024-07-31,2024-12-21,ESTIMATED,2024-12-21,2024-08-31,ESTIMATED,2024-08-31,,INTERVENTIONAL,,,Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance,Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance,WITHDRAWN,,PHASE1,0.0,ACTUAL,Massachusetts General Hospital,,2.0,,Interim analysis of data collected under other clinical trials demonstrated planned enrollment was insufficiently powered.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,OTHER,,,,,,,2024,0.0
NCT04966338,,2021-06-27,,,2022-10-16,2021-07-07,2021-07-19,ACTUAL,,,,,,,2022-10-16,2022-10-18,ACTUAL,2019-08-19,ACTUAL,2019-08-19,2022-10,2022-10-31,2021-10-01,ACTUAL,2021-10-01,2020-11-09,ACTUAL,2020-11-09,,INTERVENTIONAL,,,Efficacy and Safety of Xacrel® (Ocrelizumab) in Participants With Relapsing Remitting Multiple Sclerosis,"A Phase III, Randomized, Two-armed, Double-blind, Parallel, Active-controlled Clinical Trial to Evaluate Equivalency of the Efficacy and Safety of Ocrelizumab (CinnaGen, Iran) in Comparison to Reference Product, Ocrevus® (Roche, Switzerland) in Patients With Relapsing Multiple Sclerosis",COMPLETED,,PHASE3,170.0,ACTUAL,Cinnagen,,2.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,INDUSTRY,,,,,,,2021,1.0
NCT04508140,,2020-08-05,,,2022-12-09,2020-08-10,2020-08-11,ACTUAL,,,,,,,2022-12-09,2022-12-13,ACTUAL,2020-06-17,ACTUAL,2020-06-17,2022-12,2022-12-31,2022-12-02,ACTUAL,2022-12-02,2022-12-02,ACTUAL,2022-12-02,,INTERVENTIONAL,,,Study of BO-112 With Pembrolizumab for Colorectal or Gastric/GEJ Cancer With Liver Metastasis,Phase IIa Open-label Clinical Study of Intratumoural Administration of BO-112 in Combination With Pembrolizumab in Subjects With Liver Metastasis From Colorectal Cancer or Gastric/Gastro-oesophageal Junction Cancer,TERMINATED,,PHASE2,18.0,ACTUAL,Highlight Therapeutics,,1.0,,Low recruitment rate,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,INDUSTRY,,,,,,,2022,0.0
NCT04115956,,2019-08-29,,,2022-03-10,2019-10-02,2019-10-04,ACTUAL,,,,,,,2022-03-10,2022-03-28,ACTUAL,2020-08-06,ACTUAL,2020-08-06,2022-02,2022-02-28,2022-01-05,ACTUAL,2022-01-05,2022-01-05,ACTUAL,2022-01-05,,INTERVENTIONAL,,,A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) Amyloidosis,"An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients With AL Amyloidosis Following at Least One Prior Line of Therapy",TERMINATED,,PHASE1,6.0,ACTUAL,Oncopeptides AB,,1.0,,The sponsor decided to terminate the study following an FDA request of a partial clinical hold.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,INDUSTRY,,,,,,,2022,0.0
NCT04915404,,2021-02-23,,,2024-06-03,2021-06-01,2021-06-07,ACTUAL,,,,,,,2024-06-03,2024-06-06,ACTUAL,2022-12-07,ACTUAL,2022-12-07,2024-06,2024-06-30,2023-12-30,ACTUAL,2023-12-30,2023-12-30,ACTUAL,2023-12-30,,INTERVENTIONAL,,,Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV),"A Multicenter, Open-Label Study of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV) After Failure of Standard First Line Therapy",TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,WPD Pharmaceuticals Sp. z o.o.,,1.0,,Business decision,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,INDUSTRY,,,,,,,2023,0.0
NCT03244982,,2017-08-07,,,2020-03-13,2017-08-09,2017-08-10,ACTUAL,,,,,,,2020-03-13,2020-03-16,ACTUAL,2018-04-05,ACTUAL,2018-04-05,2020-03,2020-03-31,2020-12-01,ESTIMATED,2020-12-01,2019-07-17,ACTUAL,2019-07-17,,INTERVENTIONAL,,,Fluorescein Angiography With a Full-dose Versus a Half-dose of Intravenous Fluorescein,Comparison of Timing and Image Quality of Different Phases of Optos Fluorescein Angiography Between Two Doses of Intravenous Fluorescein: 250mg Versus 500mg,SUSPENDED,,PHASE4,79.0,ACTUAL,Kresge Eye Institute,,2.0,,Additional data may be required once preliminary data is analyzed.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,OTHER,,,,,,,2020,0.0
NCT04074317,,2019-08-28,2024-01-07,,2024-02-29,2019-08-28,2019-08-30,ACTUAL,2024-02-29,2024-03-27,ACTUAL,,,,2024-02-29,2024-03-27,ACTUAL,2019-08-22,ACTUAL,2019-08-22,2024-02,2024-02-29,2020-04-02,ACTUAL,2020-04-02,2020-04-02,ACTUAL,2020-04-02,,INTERVENTIONAL,,Baseline characteristics by enrollment arm.,"Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D","A Phase 2, Single-Dose, Randomized, Open-Label, Active-Controlled, Crossover, Pharmacodynamic, and Pharmacokinetic Comparative Study of a Novel Pramlintide-Insulin Co-Formulation in Adults With Type 1 Diabetes Mellitus",COMPLETED,,PHASE2,18.0,ACTUAL,Xeris Pharmaceuticals,,6.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,INDUSTRY,,,,,,,2020,1.0
NCT04613102,,2020-10-27,,,2021-06-15,2020-10-27,2020-11-03,ACTUAL,,,,,,,2021-06-15,2021-06-18,ACTUAL,2020-08-01,ESTIMATED,2020-08-01,2021-06,2021-06-30,2022-12-30,ESTIMATED,2022-12-30,2022-09-01,ESTIMATED,2022-09-01,,INTERVENTIONAL,,,The Efficacy and Safety of 3% Cannabidiol (CBD) Cream in Patients With Epidermolysis Bullosa: A Phase II/III Trial,The Efficacy and Safety of 3% Cannabidiol (CBD) Cream in Patients With Epidermolysis Bullosa: A Phase II/III Trial,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,The Hospital for Sick Children,,2.0,,"The study protocol should to be updated (major updates), following the second Health Canada review /requests. The study has been withdrawn form the REB review and will not be performed at SickKids.",f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 08:30:55.373207,2024-10-16 08:30:55.373207,OTHER,,,,,,,2022,0.0
NCT03247413,,2017-08-08,2023-10-06,,2024-01-01,2017-08-10,2017-08-11,ACTUAL,2024-01-01,2024-01-05,ACTUAL,,,,2024-01-01,2024-01-05,ACTUAL,2019-09-01,ACTUAL,2019-09-01,2024-01,2024-01-31,2022-10-14,ACTUAL,2022-10-14,2022-10-14,ACTUAL,2022-10-14,,INTERVENTIONAL,,,Post-lesion Administration of Dexamethasone to Prevent the Development of Neuritis After Radiofrequency Ablation,Post-lesion Administration of Dexamethasone to Prevent the Development of Neuritis After Radiofrequency Ablation,TERMINATED,,PHASE4,63.0,ACTUAL,Johns Hopkins University,,2.0,,Study has been halted prematurely,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 08:30:55.373207,2024-10-16 08:30:55.373207,OTHER,,,,,,,2022,0.0
NCT03730948,,2018-10-30,2024-02-19,,2024-04-29,2018-11-02,2018-11-05,ACTUAL,2024-04-29,2024-05-24,ACTUAL,,,,2024-04-29,2024-05-24,ACTUAL,2019-03-12,ACTUAL,2019-03-12,2024-04,2024-04-30,2022-12-01,ACTUAL,2022-12-01,2022-02-22,ACTUAL,2022-02-22,,INTERVENTIONAL,,,DC Vaccine in Colorectal Cancer,Pilot Study of Mature Dendritic Cell Vaccination for Resected Hypermutated Colorectal Cancer,TERMINATED,,PHASE1,4.0,ACTUAL,University of Pennsylvania,,1.0,,Lack of enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,OTHER,,,,,,,2022,0.0
NCT05137795,,2021-11-25,,,2023-02-02,2021-11-25,2021-11-30,ACTUAL,,,,,,,2023-02-02,2023-02-03,ACTUAL,2021-12-15,ESTIMATED,2021-12-15,2022-07,2022-07-31,2022-08-15,ESTIMATED,2022-08-15,2022-06-15,ESTIMATED,2022-06-15,,INTERVENTIONAL,AVICOVID-3,,Inhaled ZYESAMI (Aviptadil Acetate) for Treatment of Severe COVID-19,Inhaled ZYESAMI (Aviptadil Acetate) for the Treatment of Severe COVID-19 (AVICOVID-3),WITHDRAWN,,PHASE3,0.0,ACTUAL,APR Applied Pharma Research s.a.,,2.0,,Sponsor decision,t,,,,t,t,t,,,,,,,,,UNDECIDED,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,OTHER,,NCT04453839,NO_LONGER_AVAILABLE,,,,2022,0.0
NCT02901483,,2016-08-31,,,2021-12-17,2016-09-10,2016-09-15,ESTIMATED,,,,,,,2021-12-17,2022-01-11,ACTUAL,2016-10-11,ACTUAL,2016-10-11,2021-12,2021-12-31,2020-08-17,ACTUAL,2020-08-17,2020-08-17,ACTUAL,2020-08-17,,INTERVENTIONAL,,,A Study of PEP503 With Radiotherapy in Combination With Concurrent Chemotherapy for Patients With Head and Neck Cancer,A Phase 1b/2 Study of PEP503 (Radioenhancer) With Radiotherapy in Combination With Concurrent Chemotherapy for Patients With Head and Neck Cancer,TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,PharmaEngine,,1.0,,bussiness reason,f,,,,,,,,,,,,,,,,,2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,INDUSTRY,,,,,,,2020,0.0
NCT05950776,,2021-01-23,,,2023-07-17,2023-07-17,2023-07-18,ACTUAL,,,,,,,2023-07-17,2023-07-18,ACTUAL,2021-01-15,ACTUAL,2021-01-15,2023-06,2023-06-30,2022-11-02,ESTIMATED,2022-11-02,2022-11-02,ESTIMATED,2022-11-02,,INTERVENTIONAL,,,COVID-19 Trial of the Candidate Vaccine MVA-SARS-2-S in Adults,"A Multi-center, Randomized Placebo-controlled Phase II Trial to Assess the Safety, Tolerability and Immunogenicity of Two Doses of the Candidate Vaccine MVA-SARS-2-S in Adults Aged 18 to 64 and 65 and Older",WITHDRAWN,,PHASE2,0.0,ACTUAL,Universitätsklinikum Hamburg-Eppendorf,,3.0,,Results from Phase 1 lead to the decision,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,OTHER,,,,,,,2022,0.0
NCT02397356,,2014-12-01,,,2018-08-24,2015-03-18,2015-03-24,ESTIMATED,,,,,,,2018-08-24,2018-08-28,ACTUAL,2018-08,ESTIMATED,2018-08-31,2018-08,2018-08-31,2020-12,ESTIMATED,2020-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Inhaled Nebulised S(+)-Ketamine for Postoperative Analgesia,Inhaled Nebulised S(+)-Ketamine for Postoperative Analgesia,WITHDRAWN,,PHASE4,0.0,ACTUAL,Tampere University Hospital,,2.0,,Lack of study personnel,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,OTHER,,,,,,,2020,0.0
NCT03998709,,2019-06-24,,,2022-09-08,2019-06-25,2019-06-26,ACTUAL,,,,,,,2022-09-08,2022-09-09,ACTUAL,2020-02-01,ACTUAL,2020-02-01,2022-09,2022-09-30,2022-07-31,ACTUAL,2022-07-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Effect of Fasting Free Fatty Acids and Fasting Glucose on 1st and 2nd Phase Insulin Secretion,Effect of Fasting Free Fatty Acids and Fasting Glucose on 1st and 2nd Phase Insulin Secretion,WITHDRAWN,,PHASE4,0.0,ACTUAL,Mayo Clinic,,2.0,,results from other study suggest no good reason to proceed,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,OTHER,,,,,,,2022,0.0
NCT02552225,,2015-09-09,2021-09-04,,2021-10-01,2015-09-15,2015-09-17,ESTIMATED,2021-10-01,2021-10-29,ACTUAL,,,,2021-10-01,2021-10-29,ACTUAL,2016-04,ACTUAL,2016-04-30,2021-10,2021-10-31,2021-01-15,ACTUAL,2021-01-15,2021-01-15,ACTUAL,2021-01-15,,INTERVENTIONAL,,,Treatment of Chronic Laryngitis With Amitriptyline,Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitriptyline,TERMINATED,,PHASE2/PHASE3,6.0,ACTUAL,Boston Medical Center,Funding was not obtained so the study could not be continued after the Covid pause.,2.0,,Funding was not obtained so the study could not be continued after the Covid pause.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-14 21:22:01.437344,2024-10-14 21:22:01.437344,OTHER,,,,,,,2021,0.0
NCT03612739,,2018-07-20,,,2019-10-25,2018-07-27,2018-08-02,ACTUAL,,,,,,,2019-10-25,2019-10-29,ACTUAL,2018-12,ESTIMATED,2018-12-31,2018-11,2018-11-30,2021-08,ESTIMATED,2021-08-31,2019-05,ESTIMATED,2019-05-31,,INTERVENTIONAL,EPITHINK,,EPITHINK: Epigenetic Drug Treatment and Therapeutic Immunotherapy With NKR-2,"An Open-label, Phase I Study to Assess the Safety of NKR-2 Treatment Administered Concurrently With 5-azacytidine in Treatment-naïve Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients Not Candidates for Intensive Therapy",WITHDRAWN,,PHASE1,0.0,ACTUAL,Celyad Oncology SA,,3.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,INDUSTRY,,,,,,,2021,0.0
NCT03260972,,2017-08-22,,,2021-09-23,2017-08-22,2017-08-24,ACTUAL,,,,,,,2021-09-23,2021-09-29,ACTUAL,2021-06,ESTIMATED,2021-06-30,2021-09,2021-09-30,2023-06,ESTIMATED,2023-06-30,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,,,Intraabdominal Chloroprocaine During Cesarean Delivery for Pain Control,An Evaluation of Intraabdominal Chloroprocaine During Cesarean Delivery and Its Effect on Postoperative Pain and Nausea; a Randomized Controlled Trial & Pharmacokinetic-pharmacodynamics (PKPD) Analysis.,WITHDRAWN,,PHASE3,0.0,ACTUAL,Johns Hopkins University,,2.0,,Withdrawn by IRB,f,,,,t,f,f,,,f,,,,,,NO,No personal patient data will be shared with other researchers. The final de-identified manuscript will be published.,2024-10-16 08:30:55.373207,2024-10-16 08:30:55.373207,OTHER,,,,,,,2023,0.0
NCT04000555,,2019-06-17,,,2023-04-19,2019-06-24,2019-06-27,ACTUAL,,,,,,,2023-04-19,2023-04-21,ACTUAL,2019-09-01,ACTUAL,2019-09-01,2023-03,2023-03-31,2022-06-11,ACTUAL,2022-06-11,2022-06-11,ACTUAL,2022-06-11,,INTERVENTIONAL,,,Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI),"A Randomized, Double-Blinded Placebo Controlled Study To Determine the Effectiveness of Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)",TERMINATED,,PHASE4,26.0,ACTUAL,University of South Florida,,2.0,,"The study was terminated early due to low enrollment, this was partially related to our ability to recruit during the COVID-19 pandemic.",f,,,,t,t,f,,,f,,,,,,,,2024-10-16 08:30:55.373207,2024-10-16 08:30:55.373207,OTHER,,,,,,,2022,0.0
NCT02265406,,2014-10-09,,,2021-02-02,2014-10-14,2014-10-15,ESTIMATED,,,,,,,2021-02-02,2021-02-03,ACTUAL,2015-10,ACTUAL,2015-10-31,2021-02,2021-02-28,2020-07-25,ACTUAL,2020-07-25,2020-07-25,ACTUAL,2020-07-25,,INTERVENTIONAL,PROPHY-VAP,,PROPHY-VAP: Prevention of Early Ventilation Acquired Pneumonia (VAP) in Brain Injured Patients by a Single Dose of Ceftriaxone,PROPHY-VAP: Prevention of Early Ventilation Acquired Pneumonia (VAP) in Brain Injured Patients by a Single Dose of Ceftriaxone,COMPLETED,,PHASE3,354.0,ACTUAL,Poitiers University Hospital,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,OTHER,,,,,,,2020,1.0
NCT03371251,,2017-12-08,2021-11-24,,2022-02-16,2017-12-08,2017-12-13,ACTUAL,2022-02-16,2022-03-14,ACTUAL,,,,2022-02-16,2022-03-14,ACTUAL,2018-01-10,ACTUAL,2018-01-10,2022-02,2022-02-28,2020-11-26,ACTUAL,2020-11-26,2020-11-26,ACTUAL,2020-11-26,,INTERVENTIONAL,,,Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care,A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care,COMPLETED,,PHASE1/PHASE2,143.0,ACTUAL,Boston Pharmaceuticals,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,INDUSTRY,,,,,,,2020,1.0
NCT02788292,,2016-04-18,,,2024-08-19,2016-05-27,2016-06-02,ESTIMATED,,,,,,,2024-08-19,2024-08-21,ACTUAL,2016-08-15,ACTUAL,2016-08-15,2022-10,2022-10-31,2020-11-16,ACTUAL,2020-11-16,2020-11-16,ACTUAL,2020-11-16,,INTERVENTIONAL,,,Effect of N-Acetylcysteine on Autologous Fat Graft Survival,Effect of N-Acetylcysteine on Autologous Fat Graft Survival,WITHDRAWN,,PHASE4,0.0,ACTUAL,Nova Scotia Health Authority,,2.0,,unable to hire research staff,f,,,,f,,,,,,,,,,,NO,"IPD will not be available, but will be published as an average of outcomes.",2024-10-14 21:22:01.437344,2024-10-14 21:22:01.437344,OTHER,,,,,,,2020,0.0
NCT02683018,,2016-02-11,,,2021-10-28,2016-02-16,2016-02-17,ESTIMATED,,,,,,,2021-10-28,2021-11-01,ACTUAL,,,,2021-10,2021-10-31,2021-10-28,ESTIMATED,2021-10-28,2021-10-28,ACTUAL,2021-10-28,,INTERVENTIONAL,,,Investigation of Cannabis for Chronic Pain and Palliative Care,Investigation of Cannabis for Chronic Pain and Palliative Care,WITHDRAWN,,PHASE1,0.0,ACTUAL,New York State Psychiatric Institute,,2.0,,funding,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 08:30:55.373207,2024-10-16 08:30:55.373207,OTHER,,,,,,,2021,0.0
NCT03393481,,2018-01-03,,,2020-10-05,2018-01-03,2018-01-08,ACTUAL,,,,,,,2020-10-05,2020-10-08,ACTUAL,2018-10-03,ESTIMATED,2018-10-03,2020-10,2020-10-31,2020-04-17,ESTIMATED,2020-04-17,2020-01-08,ESTIMATED,2020-01-08,,INTERVENTIONAL,,,Prevention of Thromboembolic Events in Total Knee Replacement Patients,"A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Active-controlled Phase 2 Study to Compare the Efficacy and Safety of s.c. MAA868 Versus s.c. Enoxaparin in Adult Patients Undergoing Unilateral Total Knee Arthroplasty",WITHDRAWN,,PHASE2,0.0,ACTUAL,Novartis,,3.0,,Trial cancelled before First Patient First Visit (no patient enrolled),f,,,,t,f,f,,,,,,,,,UNDECIDED,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,INDUSTRY,,,,,,,2020,0.0
NCT00942331,,2009-07-17,2020-01-30,,2023-10-12,2009-07-17,2009-07-20,ESTIMATED,2020-01-30,2020-02-17,ACTUAL,,,,2023-10-12,2023-10-16,ACTUAL,2009-07-15,ACTUAL,2009-07-15,2023-10,2023-10-31,2021-06-15,ACTUAL,2021-06-15,2018-11-02,ACTUAL,2018-11-02,,INTERVENTIONAL,,,Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer,"A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma",COMPLETED,,PHASE3,506.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,NIH,,,,,,,2021,1.0
NCT02296112,,2014-11-17,2019-07-15,,2021-05-04,2014-11-17,2014-11-20,ESTIMATED,2019-07-15,2019-08-08,ACTUAL,,,,2021-05-04,2021-05-28,ACTUAL,2015-01,,2015-01-31,2021-05,2021-05-31,2021-04-16,ACTUAL,2021-04-16,2018-08,ACTUAL,2018-08-31,,INTERVENTIONAL,,,Trametinib in Treating Patients With Advanced Melanoma With BRAF Non-V600 Mutations,"A Phase II Open-Label, Two-Arm Study of the MEK Inhibitor, Trametinib, to Investigate the Safety and Anti-Cancer Activity in Subjects With Melanoma With BRAF Non-V600 Mutations",COMPLETED,,PHASE2,9.0,ACTUAL,Vanderbilt-Ingram Cancer Center,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,OTHER,,,,,,,2021,1.0
NCT03450707,,2018-02-21,2023-07-08,,2023-08-02,2018-02-26,2018-03-01,ACTUAL,2023-08-02,2023-08-24,ACTUAL,,,,2023-08-02,2023-08-24,ACTUAL,2018-05-06,ACTUAL,2018-05-06,2023-08,2023-08-31,2022-02-19,ACTUAL,2022-02-19,2022-02-19,ACTUAL,2022-02-19,,INTERVENTIONAL,THACA,,Thiamine as a Metabolic Resuscitator After Cardiac Arrest,Thiamine as a Metabolic Resuscitator After Cardiac Arrest,TERMINATED,,PHASE2,93.0,ACTUAL,Beth Israel Deaconess Medical Center,The study was stopped early by the Data Safety and Monitoring Board (DSMB) due to a signal of increased mortality in the thiamine group with a lactate \> 5,2.0,,DSMB recommendation based on differing mortality in a subgroup analysis,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,OTHER,,,,,,,2022,0.0
NCT03726333,,2018-09-24,2022-06-06,,2024-01-11,2018-10-29,2018-10-31,ACTUAL,2024-01-11,2024-06-21,ACTUAL,,,,2024-01-11,2024-06-21,ACTUAL,2020-01-14,ACTUAL,2020-01-14,2024-01,2024-01-31,2021-07-08,ACTUAL,2021-07-08,2021-07-08,ACTUAL,2021-07-08,,INTERVENTIONAL,,,Hepatic Impairment Study for Lorlatinib in Cancer Patients,A PHASE 1 STUDY TO EVALUATE THE EFFECT OF HEPATIC IMPAIRMENT ON THE PHARMACOKINETICS AND SAFETY OF LORLATINIB IN ADVANCED CANCER PATIENTS,TERMINATED,,PHASE1,1.0,ACTUAL,Pfizer,The study was terminated due to difficulties with enrolling eligible patients. Only 1 participant was enrolled in this study. Outcome measures and AE data were not reported as planned in the protocol because doing so would risk re-dentification of the individual participant.,5.0,,The study stopped due to lack of enrollment,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 08:30:55.373207,2024-10-16 08:30:55.373207,INDUSTRY,,,,,,,2021,0.0
NCT01283997,,2011-01-25,2023-07-11,,2024-06-12,2011-01-25,2011-01-26,ESTIMATED,2024-06-12,2024-06-13,ACTUAL,,,,2024-06-12,2024-06-13,ACTUAL,2011-01-25,ACTUAL,2011-01-25,2024-06,2024-06-30,2022-08-22,ACTUAL,2022-08-22,2022-08-22,ACTUAL,2022-08-22,,INTERVENTIONAL,,,Prevention of Treatment Induced Neuropathy in Multiple Myeloma,A Phase II Study of Minocycline vs. Placebo to Prevent Treatment Induced Neuropathy in Multiple Myeloma,COMPLETED,,PHASE2,79.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 08:30:55.373207,2024-10-16 08:30:55.373207,OTHER,,,,,,,2022,1.0
NCT02974725,,2016-11-23,,,2024-05-15,2016-11-23,2016-11-28,ESTIMATED,,,,,,,2024-05-15,2024-05-17,ACTUAL,2017-02-24,ACTUAL,2017-02-24,2024-05,2024-05-31,2024-04-24,ACTUAL,2024-04-24,2024-04-24,ACTUAL,2024-04-24,,INTERVENTIONAL,,,A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma,"A Phase Ib, Open-label, Multicenter Study of Oral LXH254-centric Combinations in Adult Patients With Advanced or Metastatic KRAS or BRAF Mutant Non-Small Cell Lung Cancer or NRAS Mutant Melanoma",TERMINATED,,PHASE1,241.0,ACTUAL,Novartis,,3.0,,Business reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,INDUSTRY,,,,,,,2024,0.0
NCT04291508,,2020-02-27,2024-04-23,,2024-09-25,2020-02-27,2020-03-02,ACTUAL,2024-09-25,2024-09-27,ACTUAL,,,,2024-09-25,2024-09-27,ACTUAL,2021-10-13,ACTUAL,2021-10-13,2024-09,2024-09-30,2023-07-27,ACTUAL,2023-07-27,2023-04-27,ACTUAL,2023-04-27,,INTERVENTIONAL,ASTER,"There were 487 participants randomized. For baseline variables that were missing, the measure analysis population differs from the baseline analysis population. For these variables, a footnote identifies the reason for the discrepancy.",Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery,Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery,COMPLETED,,PHASE2,488.0,ACTUAL,Massachusetts General Hospital,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,OTHER,,,,,,,2023,1.0
NCT00745134,,2008-09-02,2023-05-26,,2023-09-26,2008-09-02,2008-09-03,ESTIMATED,2023-09-26,2023-09-28,ACTUAL,,,,2023-09-26,2023-09-28,ACTUAL,2008-08-11,ACTUAL,2008-08-11,2023-09,2023-09-30,2022-11-11,ACTUAL,2022-11-11,2022-11-11,ACTUAL,2022-11-11,,INTERVENTIONAL,,,Radiation Therapy and Capecitabine With or Without Curcumin Before Surgery in Treating Patients With Rectal Cancer,A Randomized Double Blinded Study of Curcumin With Pre-operative Capecitabine and Radiation Therapy Followed by Surgery for Rectal Cancer,TERMINATED,,PHASE2,22.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,The trial was stopped early because there was only one patient with pCR among the first 15 patients randomized to the curcumin arm.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,OTHER,,,,,,,2022,0.0
NCT05414006,,2022-06-01,,,2023-02-22,2022-06-08,2022-06-10,ACTUAL,,,,,,,2023-02-22,2023-02-24,ACTUAL,2022-06-14,ACTUAL,2022-06-14,2022-09,2022-09-30,2022-09-05,ACTUAL,2022-09-05,2022-08-31,ACTUAL,2022-08-31,,INTERVENTIONAL,,,Effect of S-ketamine in Cesarean Section Combined Anesthesia,Effect of S-ketamine in Cesarean Section Combined Anesthesia,COMPLETED,,PHASE4,120.0,ACTUAL,The Second Affiliated Hospital of Chongqing Medical University,,4.0,,,f,,,,t,f,f,,,,,,Within five years,,,YES,The individual participant data for this study is available from the sponsor on reasonable request through email,2024-10-15 22:24:24.585919,2024-10-15 22:24:24.585919,OTHER,,,,,,,2022,1.0
NCT05227131,,2022-01-27,,,2022-07-06,2022-01-27,2022-02-07,ACTUAL,,,,,,,2022-07-06,2022-07-11,ACTUAL,2022-05-15,ESTIMATED,2022-05-15,2022-07,2022-07-31,2024-10,ESTIMATED,2024-10-31,2024-10,ESTIMATED,2024-10-31,,INTERVENTIONAL,MARGARET,,Margetuximab Plus Tucatinib and Capecitabine in HER2-positive Metastatic Breast Cancer,A Phase II Trial of Margetuximab in Combination With Tucatinib and Capecitabine in Patients With HER2-Positive Metastatic Breast Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,MedSIR,,1.0,,Funder decided to not continue the study,f,,,,f,f,f,,,,,,,,,,,2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,OTHER,,,,,,,2024,0.0
NCT04776746,,2020-11-29,2024-08-19,,2024-09-24,2021-02-26,2021-03-02,ACTUAL,2024-09-24,2024-09-27,ACTUAL,,,,2024-09-24,2024-09-27,ACTUAL,2020-11-08,ACTUAL,2020-11-08,2024-09,2024-09-30,2023-06-30,ACTUAL,2023-06-30,2023-06-30,ACTUAL,2023-06-30,,INTERVENTIONAL,,All patients enrolled and treated with trofinetide,Open-Label Extension Study of Trofinetide for Rett Syndrome,An Open-Label Extension Study of Continuing Treatment With Trofinetide for Rett Syndrome,TERMINATED,,PHASE3,77.0,ACTUAL,ACADIA Pharmaceuticals Inc.,"As a result of marketing approval of trofinetide on 10 March 2023, the study was terminated by the Sponsor with the intent of switching patients to commercially available product. Date of study termination was 30 June 2023.",1.0,,"As a result of marketing approval of trofinetide on 10 March 2023, the study was terminated by the Sponsor with the intent of switching patients to commercially available product.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,INDUSTRY,,,,,,,2023,0.0
NCT04044209,,2019-07-25,,,2022-01-06,2019-08-01,2019-08-05,ACTUAL,,,,,,,2022-01-06,2022-01-20,ACTUAL,2020-02-12,ACTUAL,2020-02-12,2022-01,2022-01-31,2023-09,ESTIMATED,2023-09-30,2021-09,ESTIMATED,2021-09-30,,INTERVENTIONAL,,,"A Study of the IDH1 Inhibitor AG-120 in Combination With the Checkpoint Blockade Inhibitor, Nivolumab, for Patients With IDH1 Mutated Relapsed/Refractory AML and High Risk MDS","A Phase II of the IDH1 Inhibitor AG-120 in Combination With the Checkpoint Blockade Inhibitor, Nivolumab, for Patients With IDH1 Mutated Relapsed/Refractory AML and High Risk MDS",WITHDRAWN,,PHASE2,0.0,ACTUAL,Yale University,,1.0,,No patients were able to be screened nor enrolled.,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 08:30:55.373207,2024-10-16 08:30:55.373207,OTHER,,,,,,,2023,0.0
NCT04921358,,2021-05-25,,,2024-02-27,2021-06-07,2021-06-10,ACTUAL,,,,,,,2024-02-27,2024-02-28,ACTUAL,2021-07-27,ACTUAL,2021-07-27,2024-02,2024-02-29,2023-12-20,ACTUAL,2023-12-20,2023-12-20,ACTUAL,2023-12-20,,INTERVENTIONAL,,,Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer,SAFFRON-301: A Randomized Phase 3 Study of Tislelizumab in Combination With Sitravatinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Progressed on or After Platinum-Based Chemotherapy and Anti-PD-(L)1 Antibody,TERMINATED,,PHASE3,377.0,ACTUAL,BeiGene,,2.0,,"Due to safety risks and unfavorable risk-benefit assessment results, the sponsor has decided to voluntarily terminate the study.",f,,,,t,f,f,,,f,,,,,,YES,,2024-10-15 11:32:29.485696,2024-10-15 11:32:29.485696,INDUSTRY,,,,,,,2023,0.0
NCT04861948,,2021-04-22,,,2022-10-03,2021-04-24,2021-04-27,ACTUAL,,,,,,,2022-10-03,2022-10-04,ACTUAL,2021-05-25,ACTUAL,2021-05-25,2022-10,2022-10-31,2022-07-30,ACTUAL,2022-07-30,2022-07-30,ACTUAL,2022-07-30,,INTERVENTIONAL,,,IBI188 Combination Therapy in Solid Tumors,"Phase Ib Study to Evaluate the Efficacy, Safety and Tolerability of IBI188 Combination Therapy in Subjects With Advanced Malignancies",TERMINATED,,PHASE1,9.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,4.0,,No signs of efficacy in solid tumors,f,,,,f,f,f,,,,,,,,,,,2024-10-16 08:30:55.373207,2024-10-16 08:30:55.373207,INDUSTRY,,,,,,,2022,0.0
NCT03781479,,2018-12-18,2021-04-06,,2021-05-28,2018-12-18,2018-12-20,ACTUAL,2021-05-28,2021-06-01,ACTUAL,,,,2021-05-28,2021-06-01,ACTUAL,2019-01-21,ACTUAL,2019-01-21,2021-05,2021-05-31,2020-07-23,ACTUAL,2020-07-23,2020-07-23,ACTUAL,2020-07-23,,INTERVENTIONAL,,"The analysis of baseline characteristics included all patients in the Safety population, who are those patients who enrolled and received at least one dose of amifampridine. Patients who began the Run-in period regardless of whether they were randomized to double blind medication on Day 0 belong to the Safety population.",Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients,"A Randomized, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of Amifampridine Phosphate in Ambulatory Patients With Spinal Muscular Atrophy (SMA) Type 3",COMPLETED,,PHASE2,13.0,ACTUAL,"Catalyst Pharmaceuticals, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 21:22:01.437344,2024-10-14 21:22:01.437344,INDUSTRY,,,,,,,2020,1.0
NCT03395639,,2018-01-04,2022-06-02,,2022-07-05,2018-01-04,2018-01-10,ACTUAL,2022-07-05,2022-07-26,ACTUAL,,,,2022-07-05,2022-07-26,ACTUAL,2018-05-15,ACTUAL,2018-05-15,2022-07,2022-07-31,2021-12-03,ACTUAL,2021-12-03,2021-12-03,ACTUAL,2021-12-03,,INTERVENTIONAL,,Demographic and baseline characteristics were assessed in the Intent to Treat Population (ITT).,Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease,"An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events",COMPLETED,,PHASE3,168.0,ACTUAL,Daiichi Sankyo,,2.0,,,f,,,,t,t,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,INDUSTRY,,,,,,,2021,1.0
NCT04094766,,2019-09-17,,,2020-11-03,2019-09-17,2019-09-19,ACTUAL,,,,,,,2020-11-03,2020-11-05,ACTUAL,2017-08-01,ACTUAL,2017-08-01,2020-11,2020-11-30,2020-08-30,ESTIMATED,2020-08-30,2020-08-30,ESTIMATED,2020-08-30,,INTERVENTIONAL,,,Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy in R/R Acute B Lymphoblastic Leukemia,A Phase I Clinical Study of Dual Specificity CD19 and CD22 Chimeric Antigen Receptor T Cell Therapy in Relapsed or Refractory Acute B Lymphoblastic Leukemia,WITHDRAWN,,PHASE1,0.0,ACTUAL,Second Affiliated Hospital of Xi'an Jiaotong University,,1.0,,Production plan adjustment,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 08:30:55.373207,2024-10-16 08:30:55.373207,OTHER,,,,,,,2020,0.0
NCT03900754,,2019-04-01,,,2024-04-22,2019-04-02,2019-04-03,ACTUAL,,,,,,,2024-04-22,2024-04-24,ACTUAL,2020-01-13,ACTUAL,2020-01-13,2024-04,2024-04-30,2024-01-31,ACTUAL,2024-01-31,2024-01-31,ACTUAL,2024-01-31,,INTERVENTIONAL,,,A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia,A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia,TERMINATED,,PHASE2,26.0,ACTUAL,VA Office of Research and Development,,2.0,,Inadequate Subject Recruitment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 08:30:55.373207,2024-10-16 08:30:55.373207,FED,,,,,,,2024,0.0
NCT03552029,,2018-05-17,2021-12-13,,2022-03-14,2018-05-29,2018-06-11,ACTUAL,2022-03-14,2022-05-20,ACTUAL,,,,2022-03-14,2022-05-20,ACTUAL,2018-12-12,ACTUAL,2018-12-12,2022-03,2022-03-31,2021-04-01,ACTUAL,2021-04-01,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,,Demographics and baseline characteristics were assessed in the Enrolled Analysis Set.,Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML),"A Phase 1 Study of Milademetan in Combination With Quizartinib in Subjects With FLT3-ITD Mutant Acute Myeloid Leukemia That Are Relapsed/Refractory, or Newly Diagnosed and Unfit for Intensive Chemotherapy",TERMINATED,,PHASE1,10.0,ACTUAL,Daiichi Sankyo,This study was terminated based on a business decision by the Sponsor and was not due to a safety concern.,3.0,,This study was terminated based on a business decision by the Sponsor.,f,,,,t,t,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-14 21:22:01.437344,2024-10-14 21:22:01.437344,INDUSTRY,,,,,,,2021,0.0
NCT02790736,,2016-05-26,2018-07-12,,2023-05-11,2016-06-03,2016-06-06,ESTIMATED,2018-08-06,2018-09-05,ACTUAL,,,,2023-05-11,2023-06-07,ACTUAL,2016-06,ACTUAL,2016-06-30,2023-05,2023-05-31,2020-10-30,ACTUAL,2020-10-30,2020-10-30,ACTUAL,2020-10-30,,INTERVENTIONAL,,,Brief Intervention to Reduce Fear of Public Speaking,Brief Intervention to Reduce Fear of Public Speaking,TERMINATED,,PHASE4,6.0,ACTUAL,New York State Psychiatric Institute,Early termination of this pilot study leading to small numbers of subjects evaluated,2.0,,COVID-19 restrictions,f,,,,f,,,,,,,,,,,NO,,2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,OTHER,,,,,,,2020,0.0
NCT03446651,,2018-02-20,2023-12-14,,2024-01-22,2018-02-20,2018-02-27,ACTUAL,2024-01-22,2024-01-30,ACTUAL,,,,2024-01-22,2024-01-30,ACTUAL,2018-07-12,ACTUAL,2018-07-12,2024-01,2024-01-31,2022-09-07,ACTUAL,2022-09-07,2022-09-07,ACTUAL,2022-09-07,,INTERVENTIONAL,,,Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure,Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure,COMPLETED,,EARLY_PHASE1,50.0,ACTUAL,Yale University,This is preliminary data analysis conducted solely for the purpose of complying with clinicaltrials.gov timelines,2.0,,,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 08:30:55.373207,2024-10-16 08:30:55.373207,OTHER,,,,,,,2022,1.0
NCT05070728,,2021-09-27,,,2023-09-06,2021-10-06,2021-10-07,ACTUAL,,,,,,,2023-09-06,2023-09-08,ACTUAL,2021-11-17,ACTUAL,2021-11-17,2023-09,2023-09-30,2023-04-12,ACTUAL,2023-04-12,2022-10-17,ACTUAL,2022-10-17,,INTERVENTIONAL,,,Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert (FAI),"A Phase 3, Multicenter, Prospective, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide (FA) Intravitreal 0.05 mg Insert (Yutiq 0.05 mg) in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye",TERMINATED,,PHASE3,12.0,ACTUAL,"EyePoint Pharmaceuticals, Inc.",,2.0,,No longer pursuing indication,f,,,,f,t,f,,,,,,,,,,,2024-10-16 08:30:55.373207,2024-10-16 08:30:55.373207,INDUSTRY,,,,,,,2023,0.0
NCT04208412,,2019-12-20,2021-11-30,,2023-01-16,2019-12-20,2019-12-23,ACTUAL,2023-01-16,2023-02-08,ACTUAL,,,,2023-01-16,2023-02-08,ACTUAL,2019-07-02,ACTUAL,2019-07-02,2023-01,2023-01-31,2020-12-08,ACTUAL,2020-12-08,2020-12-08,ACTUAL,2020-12-08,,INTERVENTIONAL,,,"A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II","A Randomized, Double-blind, Placebo-controlled, Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II",COMPLETED,,PHASE2,84.0,ACTUAL,"KalVista Pharmaceuticals, Ltd.",,3.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,INDUSTRY,,,,,,,2020,1.0
NCT04442269,,2020-06-04,2024-07-25,,2024-07-25,2020-06-19,2020-06-22,ACTUAL,2024-07-25,2024-08-21,ACTUAL,,,,2024-07-25,2024-08-21,ACTUAL,2020-09-15,ACTUAL,2020-09-15,2024-07,2024-07-31,2024-02-09,ACTUAL,2024-02-09,2023-07-27,ACTUAL,2023-07-27,,INTERVENTIONAL,,,Investigating Treatment With Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED),"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis",COMPLETED,,PHASE2,62.0,ACTUAL,Regeneron Pharmaceuticals,,2.0,,,f,,,,t,t,f,,,,,,"Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.","Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).",https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,INDUSTRY,,,,,,,2024,1.0
NCT03128528,,2017-04-03,,,2020-09-25,2017-04-20,2017-04-25,ACTUAL,,,,,,,2020-09-25,2020-09-28,ACTUAL,2017-07-01,ACTUAL,2017-07-01,2020-09,2020-09-30,2020-04-30,ACTUAL,2020-04-30,2020-01-31,ACTUAL,2020-01-31,,INTERVENTIONAL,ELSI,,Analysing the Effect of Empagliflozin on Reduction of Tissue Sodium Content in Patients With Chronic Heart Failure,"Randomized, Double-blind, Placebo Controlled, Parallel-group, Prospective Clinical Study to Analyse the Effect of Empagliflozin on Reduction of Tissue Sodium Content in Patients With Chronic Heart Failure",COMPLETED,,PHASE2,84.0,ACTUAL,University of Erlangen-Nürnberg Medical School,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,OTHER,,,,,,,2020,1.0
NCT03919162,,2019-04-15,,,2024-08-19,2019-04-17,2019-04-18,ACTUAL,,,,,,,2024-08-19,2024-08-21,ACTUAL,2021-11-15,ACTUAL,2021-11-15,2024-08,2024-08-31,2024-08-12,ACTUAL,2024-08-12,2024-07-12,ACTUAL,2024-07-12,,INTERVENTIONAL,VIVA-MIND,,A Trial to Evaluate the Efficacy and Safety of PQ912 in Patients With Early AD,A Phase 2A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Varoglutamstat (PQ912) in Patients With Early Alzheimer's Disease With a Stage-Gate to Phase 2B (VIVA-MIND),TERMINATED,,PHASE2,112.0,ACTUAL,Vivoryon Therapeutics N.V.,,4.0,,It has been made the strategic decision to terminate the study. This decision to terminate the study early is not being made for safety reasons.,f,,,,t,t,f,,,,,,,,,YES,,2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,INDUSTRY,,,,,,,2024,0.0
NCT03840967,,2019-02-12,2024-05-06,,2024-05-06,2019-02-13,2019-02-15,ACTUAL,2024-05-06,2024-06-04,ACTUAL,,,,2024-05-06,2024-06-04,ACTUAL,2019-07-09,ACTUAL,2019-07-09,2024-05,2024-05-31,2023-02-22,ACTUAL,2023-02-22,2022-11-17,ACTUAL,2022-11-17,,INTERVENTIONAL,,,A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma,A Phase II Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Homologous Recombination (HR) Defective or Loss of Heterozygosity (LOH) High Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma,TERMINATED,,PHASE2,14.0,ACTUAL,Hoosier Cancer Research Network,,1.0,,Due to slow accruals,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,OTHER,,,,,,,2023,0.0
NCT04120987,,2019-09-25,,,2023-07-25,2019-10-07,2019-10-09,ACTUAL,,,,,,,2023-07-25,2023-07-27,ACTUAL,2021-05-31,ACTUAL,2021-05-31,2023-07,2023-07-31,2022-06-25,ACTUAL,2022-06-25,2022-06-25,ACTUAL,2022-06-25,,INTERVENTIONAL,,,Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra,The Incidence of Ocular Inflammation as Defined by the Inflammadry Assay in 250 Consecutive Cataract Patients and Their Response to Treatment With Xiidra,WITHDRAWN,,PHASE4,0.0,ACTUAL,Bucci Laser Vision Institute,,2.0,,Administrative,f,,,,f,t,f,,,f,,,,,,,,2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,OTHER,,,,,,,2022,0.0
NCT04317001,,2020-03-17,,,2020-03-18,2020-03-18,2020-03-20,ACTUAL,,,,,,,2020-03-18,2020-03-20,ACTUAL,2018-12-01,ESTIMATED,2018-12-01,2020-03,2020-03-31,2024-11-30,ESTIMATED,2024-11-30,2022-11-30,ESTIMATED,2022-11-30,,INTERVENTIONAL,T-CID,,Treatment for Cognitive Impairment in Depression,Developing Improved Treatment for Cognitive Impairment in Depression,WITHDRAWN,,PHASE3,0.0,ACTUAL,Stanford University,,2.0,,Researcher leading the study moved institutions study not feasible,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,OTHER,,,,,,,2024,0.0
NCT05549908,,2022-09-14,,,2024-03-11,2022-09-18,2022-09-22,ACTUAL,,,,,,,2024-03-11,2024-03-13,ACTUAL,2020-07-22,ACTUAL,2020-07-22,2023-02,2023-02-28,2023-04-20,ACTUAL,2023-04-20,2021-10-31,ACTUAL,2021-10-31,,INTERVENTIONAL,,,Vaccine Prevention of Rabies Adopts 4-shot Immunization Method,"Randomized, Blind, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell) Inoculated in 4-dose Program (2-1-1)",COMPLETED,,PHASE3,1800.0,ACTUAL,"Changchun Zhuoyi Biological Co., Ltd",,3.0,,,f,,,,f,f,f,,,,,,before December 2023.,public for all.,,YES,all results.,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,OTHER,,,,,,,2023,1.0
NCT01988571,,2013-11-01,2021-09-29,,2021-12-06,2013-11-19,2013-11-20,ESTIMATED,2021-12-06,2022-01-04,ACTUAL,,,,2021-12-06,2022-01-04,ACTUAL,2014-02-01,ACTUAL,2014-02-01,2021-12,2021-12-31,2020-09-24,ACTUAL,2020-09-24,2020-09-24,ACTUAL,2020-09-24,,INTERVENTIONAL,,,Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT),Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT),COMPLETED,,PHASE2,279.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,OTHER,,,,,,,2020,1.0
NCT05259397,,2022-02-15,,,2023-03-07,2022-02-25,2022-02-28,ACTUAL,,,,,,,2023-03-07,2023-03-08,ACTUAL,2022-03-24,ACTUAL,2022-03-24,2023-03,2023-03-31,2022-09-19,ACTUAL,2022-09-19,2022-09-19,ACTUAL,2022-09-19,,INTERVENTIONAL,,,PF-07225570 Alone or in Combination With an Anti-PD-1 Antibody in Recurrent Non-muscle Invasive Bladder Cancer (NMIBC),"A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-07225570 EITHER ALONE OR IN COMBINATION WITH AN ANTI-PD-1 ANTIBODY, IN PARTICIPANTS WITH RECURRENT NON-MUSCLE INVASIVE BLADDER CANCER",WITHDRAWN,,PHASE1,0.0,ACTUAL,Pfizer,,4.0,,Pfizer has decided to terminate Study C4661001 due to strategic considerations. This decision is not due to any specific safety reasons or requests from any regulatory authorities. No participants have been enrolled in this study.,f,,,,,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,,,,,,2022,0.0
NCT04157075,,2019-11-06,,,2022-11-07,2019-11-07,2019-11-08,ACTUAL,,,,,,,2022-11-07,2022-11-09,ACTUAL,2021-03-15,ACTUAL,2021-03-15,2022-03,2022-03-31,2022-10-15,ACTUAL,2022-10-15,2022-10-15,ACTUAL,2022-10-15,,INTERVENTIONAL,,,Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy,The Effect of Intra-operative Uterosacral Bupivacaine Injection on Post-operative Pain in Patients Undergoing Minimally Invasive Hysterectomy,COMPLETED,,EARLY_PHASE1,180.0,ACTUAL,Johns Hopkins University,,3.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,OTHER,,,,,,,2022,0.0
NCT03860207,,2019-02-28,2023-01-27,,2023-08-31,2019-02-28,2019-03-01,ACTUAL,2023-05-25,2023-06-22,ACTUAL,,,,2023-08-31,2023-09-13,ACTUAL,2019-02-22,ACTUAL,2019-02-22,2023-08,2023-08-31,2021-10-20,ACTUAL,2021-10-20,2021-10-20,ACTUAL,2021-10-20,,INTERVENTIONAL,,Safety Analysis Set.~In Protocol version 1.0 to 5.0 patients ≥ 1 year were eligible. In Protocol version 6.0 to 10.0 patients between ≥ 1 year and \< 18 years were eligible.,"Study of the Safety and Efficacy of Humanized 3F8 Bispecific Antibody (Hu3F8-BsAb) in Patients With Relapsed/Refractory Neuroblastoma, Osteosarcoma and Other Solid Tumor Cancers","Phase I/II Study of Humanized 3F8 Bispecific Antibody (Hu3F8-BsAb) in Patients With Relapsed/Refractory Neuroblastoma, Osteosarcoma, and Other GD2(+) Solid Tumors",TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,Y-mAbs Therapeutics,The study was terminated after 11 subjects due to a business strategy decision. At this point the maximum tolerated dose was not established.,1.0,,study terminated due to business priorities,,,,,,t,f,,,,,,,,,,,2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,INDUSTRY,,,,,,,2021,0.0
NCT03311269,,2017-10-11,2020-05-15,,2022-02-09,2017-10-11,2017-10-17,ACTUAL,2022-02-09,2022-03-02,ACTUAL,,,,2022-02-09,2022-03-02,ACTUAL,2017-09-22,ACTUAL,2017-09-22,2022-02,2022-02-28,2020-03-27,ACTUAL,2020-03-27,2018-05-15,ACTUAL,2018-05-15,,INTERVENTIONAL,VICARES,,A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency,"A Prospective, Randomized, Controlled, Multi-Center, Double Blind Study of ClariVein RES for Treatment of Venous Insufficiency Associated With Incompetent Saphenous Veins Due to Superficial Venous Reflux",TERMINATED,,PHASE2,19.0,ACTUAL,"Vascular Insights, LLC","A total of 19 subjects were enrolled in the study. The study was terminated for administrative reasons; there were no safety or efficacy concerns. It was determined by the sponsor that the Phase 3 protocol, which is designed to closely mimic the Phase 2 protocol, would be adequate to collect safety and efficacy assessments with minor adjustments.",2.0,,Study was terminated for administrative reasons,f,,,,f,t,t,,,,,,,,,NO,,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,,,,,,2020,0.0
NCT02989857,,2016-12-05,2022-01-28,2020-01-30,2024-07-24,2016-12-08,2016-12-12,ESTIMATED,2022-03-18,2022-04-13,ACTUAL,2022-03-18,2022-04-13,ACTUAL,2024-07-24,2024-08-20,ACTUAL,2017-02-20,ACTUAL,2017-02-20,2024-07,2024-07-31,2021-05-17,ACTUAL,2021-05-17,2019-01-31,ACTUAL,2019-01-31,,INTERVENTIONAL,ClarIDHy,"Intent-To-Treat (ITT) Set included all participants who were randomized, with the treatment group designated according to the randomization.",Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy),"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation",COMPLETED,,PHASE3,187.0,ACTUAL,Servier,,3.0,,,f,,,,t,t,f,,,,,,After Marketing Authorisation in EEA or US if the study is used for the approval.,Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.,https://clinicaltrials.servier.com/,YES,"Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.",2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,INDUSTRY,,,,,,,2021,1.0
NCT02448381,,2015-05-13,2022-02-14,,2022-03-22,2015-05-14,2015-05-19,ESTIMATED,2022-03-22,2022-04-15,ACTUAL,,,,2022-03-22,2022-04-15,ACTUAL,2015-12,ACTUAL,2015-12-31,2022-03,2022-03-31,2020-11,ACTUAL,2020-11-30,2020-06,ACTUAL,2020-06-30,,INTERVENTIONAL,,The baseline analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301 or Placebo),FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides),"A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Determine the Efficacy of Topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma",COMPLETED,,PHASE3,169.0,ACTUAL,Soligenix,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,INDUSTRY,,,,,,,2020,1.0
NCT04830878,,2021-03-31,,,2023-04-18,2021-03-31,2021-04-05,ACTUAL,,,,,,,2023-04-18,2023-04-20,ACTUAL,2021-04,ESTIMATED,2021-04-30,2023-04,2023-04-30,2024-04,ESTIMATED,2024-04-30,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,SIGHT,,Methotrexate For The Prevention and Treatment of Proliferative Vitreoretinopathy in Pediatric Patients,"A Phase I, Multicenter, Uncontrolled, Open Label Study Assessing the Efficacy and Safety of a Combination of Systemic and Intravitreal Injections of Methotrexate for the Prevention and Treatment of Proliferative Vitreoretinopathy in Pediatric Patients With RheGmatogenous Retinal DetacHmenT (the SIGHT Study)",WITHDRAWN,,PHASE1,0.0,ACTUAL,Stanford University,,1.0,,Lack of funding,f,,,,,t,f,,,,,,,,,,,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,OTHER,,,,,,,2024,0.0
NCT04096326,,2019-09-04,2023-07-10,2021-07-12,2023-07-10,2019-09-18,2019-09-19,ACTUAL,2023-07-10,2023-07-28,ACTUAL,2021-07-12,2021-07-16,ACTUAL,2023-07-10,2023-07-28,ACTUAL,2019-09-26,ACTUAL,2019-09-26,2023-07,2023-07-31,2020-09-09,ACTUAL,2020-09-09,2020-09-09,ACTUAL,2020-09-09,,INTERVENTIONAL,,Modified intent-to-treat (mITT) population included all randomized participants who received the study intervention and who had at least one postintervention investigator-rated facial wrinkle scale with photonumeric guide (FWS) measurement at maximum frown.,AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines,"A Phase 2b Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of AGN-151586 in Participants With Moderate to Severe Glabellar Lines",COMPLETED,,PHASE2,198.0,ACTUAL,Allergan,,10.0,,,f,,,,t,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,INDUSTRY,,,,,,,2020,1.0
NCT04680637,,2020-12-18,2024-05-21,,2024-06-26,2020-12-18,2020-12-23,ACTUAL,2024-06-26,2024-06-28,ACTUAL,,,,2024-06-26,2024-06-28,ACTUAL,2021-05-06,ACTUAL,2021-05-06,2024-06,2024-06-30,2023-05-22,ACTUAL,2023-05-22,2023-05-22,ACTUAL,2023-05-22,,INTERVENTIONAL,,Full Analysis Set: Included all participants randomized in the study.,Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus,A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy,TERMINATED,,PHASE2,168.0,ACTUAL,Amgen,This study was discontinued early due to meeting predefined futility criteria at its third interim analysis.,4.0,,The trial was terminated prematurely as it met pre-defined criteria for futility at IA3.,,,,,t,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,,,,,,2023,0.0
NCT03925246,,2019-03-14,,,2024-03-29,2019-04-23,2019-04-24,ACTUAL,,,,,,,2024-03-29,2024-04-02,ACTUAL,2019-07-30,ACTUAL,2019-07-30,2024-03,2024-03-31,2021-08-18,ACTUAL,2021-08-18,2020-12-02,ACTUAL,2020-12-02,,INTERVENTIONAL,REVOLUMAB,,Efficacy of Nivolumab for Recurrent IDH Mutated High-Grade Gliomas,A Phase II Study From the POLA National Network of Nivolumab for Recurrent IDH Mutated High-Grade Gliomas,COMPLETED,,PHASE2,43.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,1.0,,,f,,,,t,f,f,,,,,,Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor.,Researchers who provide a methodologically sound proposal.,,YES,"Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.~Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.",2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,OTHER,,,,,,,2021,0.0
NCT03801356,,2019-01-09,2023-02-08,,2023-06-29,2019-01-09,2019-01-11,ACTUAL,2023-06-29,2023-07-21,ACTUAL,,,,2023-06-29,2023-07-21,ACTUAL,2018-08-23,ACTUAL,2018-08-23,2023-06,2023-06-30,2020-12-15,ACTUAL,2020-12-15,2020-11-05,ACTUAL,2020-11-05,,INTERVENTIONAL,,,Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy,Defining the Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy,TERMINATED,,PHASE4,11.0,ACTUAL,The Cleveland Clinic,"The study was terminated early due to a number of concurrent issues. We found it difficult to enroll patients. Many of the patients were from out of region and/or had presented with a concurrent spinal injection. A new study injection could not be ordered due to the aforementioned issues. We attempted to mitigate, but it proved to be difficult.",1.0,,"The study was terminated early due to a number of concurrent issues: low enrollment, limited data and COVID-19.",f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,OTHER,,,,,,,2020,0.0
NCT04361461,,2020-04-22,,,2020-11-18,2020-04-23,2020-04-24,ACTUAL,,,,,,,2020-11-18,2020-11-19,ACTUAL,2020-04-30,ESTIMATED,2020-04-30,2020-06,2020-06-30,2020-11-04,ESTIMATED,2020-11-04,2020-11-04,ESTIMATED,2020-11-04,,INTERVENTIONAL,,,Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19),Hydroxychloroquine or Hydroxychloroquine Associated With Azithromycin for Inpatients With Moderate or Severe Lung Disease Due to SARS-CoV-2 (COVID-19),WITHDRAWN,,PHASE3,0.0,ACTUAL,Apsen Farmaceutica S.A.,,2.0,,This study was canceled before enrollment due to a decision by the Sponsor,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,INDUSTRY,,,,,,,2020,0.0
NCT04046549,,2019-08-02,2023-06-21,,2023-10-09,2019-08-02,2019-08-06,ACTUAL,2023-10-09,2023-10-10,ACTUAL,,,,2023-10-09,2023-10-10,ACTUAL,2019-10-30,ACTUAL,2019-10-30,2023-10,2023-10-31,2023-03-22,ACTUAL,2023-03-22,2022-07-18,ACTUAL,2022-07-18,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant,"A Phase 2a Single-arm, Prospective, Open-label Pilot Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant",COMPLETED,,PHASE2,25.0,ACTUAL,Viela Bio (acquired by Horizon Therapeutics),,1.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,INDUSTRY,,,,,,,2023,0.0
NCT02607488,,2015-11-15,,,2020-09-02,2015-11-17,2015-11-18,ESTIMATED,,,,,,,2020-09-02,2020-09-04,ACTUAL,2020-11,ESTIMATED,2020-11-30,2020-09,2020-09-30,2023-02,ESTIMATED,2023-02-28,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Perioperative Systemic Lidocaine for Enhanced Bowel Recovery After Bariatric Surgery,Perioperative Systemic Lidocaine for Enhanced Bowel Recovery After Laparoscopic Bariatric Surgery: A Dose Dependent Study,SUSPENDED,,PHASE1/PHASE2,180.0,ESTIMATED,Mansoura University,,4.0,,No fund no enough recruiting centers,f,,,,t,f,f,,,,,,,,,,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,OTHER,,,,,,,2023,0.0
NCT03361124,,2017-08-01,,,2019-02-19,2017-11-28,2017-12-04,ACTUAL,,,,,,,2019-02-19,2019-02-21,ACTUAL,2019-03-01,ESTIMATED,2019-03-01,2019-02,2019-02-28,2020-03-01,ESTIMATED,2020-03-01,2020-03-01,ESTIMATED,2020-03-01,,INTERVENTIONAL,,,Oxytocin Dosing at Planned Cesarean Section and Anemia,Oxytocin Dosing at Planned Cesarean Section and Postpartum Anemia: A Comparison of Two Protocols,WITHDRAWN,,PHASE4,0.0,ACTUAL,Milton S. Hershey Medical Center,,2.0,,Investigator no longer interested in proceeding with study,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,OTHER,,,,,,,2020,0.0
NCT05167513,,2021-11-29,,,2022-04-28,2021-12-09,2021-12-22,ACTUAL,,,,,,,2022-04-28,2022-05-04,ACTUAL,2021-01-01,ACTUAL,2021-01-01,2022-04,2022-04-30,2022-04-28,ACTUAL,2022-04-28,2022-04-28,ACTUAL,2022-04-28,,INTERVENTIONAL,DQOL,,Monitoring Parameters Beyond Glycemic Control: Impact of Sitagliptin on Quality of Life in Type 2 Diabetes Patients,Monitoring Parameters Beyond Glycemic Control: Impact of Sitagliptin on Quality of Life in Type 2 Diabetes Patients,COMPLETED,,PHASE4,188.0,ACTUAL,Getz Pharma,,1.0,,,f,,,,t,f,f,,,f,,,,,,NO,"Diabetes Quality of Life (DQOL) scores, HbA1c, Fasting Blood Sugars (FBS) (masking patients' identity)",2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,,,,,,2022,1.0
NCT04000919,,2019-06-19,,,2022-10-13,2019-06-25,2019-06-27,ACTUAL,,,,,,,2022-10-13,2022-10-17,ACTUAL,2019-06-19,ACTUAL,2019-06-19,2022-10,2022-10-31,2023-12-30,ESTIMATED,2023-12-30,2023-06-30,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,Effects of 5HTP and LDOPA on CNS Excitability After SCI,"The Effects of 5-hydroxytryptophan (5-HTP) and L-3,4-dihydroxyphenylalanine (L-DOPA) Supplementation on Central Nervous System Excitability and Motor Function in Individuals With Spinal Cord Injury",SUSPENDED,,PHASE2/PHASE3,30.0,ESTIMATED,University of Louisville,,4.0,,PI left UofL and intends to reopen study at University of Alberta,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,OTHER,,,,,,,2023,0.0
NCT04435626,,2020-06-15,,,2024-07-01,2020-06-15,2020-06-17,ACTUAL,,,,,,,2024-07-01,2024-07-03,ACTUAL,2020-09-14,ACTUAL,2020-09-14,2024-06,2024-06-30,2024-06-14,ACTUAL,2024-06-14,2024-05-15,ACTUAL,2024-05-15,,INTERVENTIONAL,FINEARTS-HF,,Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%,"A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Finerenone on Morbidity and Mortality in Participants With Heart Failure (NYHA II-IV) and Left Ventricular Ejection Fraction ≥ 40% (LVEF ≥ 40%)",COMPLETED,,PHASE3,6016.0,ACTUAL,Bayer,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,INDUSTRY,,,,,,,2024,1.0
NCT03918447,,2019-04-12,2024-04-26,,2024-06-10,2019-04-16,2019-04-17,ACTUAL,2024-06-10,2024-06-11,ACTUAL,,,,2024-06-10,2024-06-11,ACTUAL,2019-05-29,ACTUAL,2019-05-29,2024-06,2024-06-30,2023-08-08,ACTUAL,2023-08-08,2023-08-08,ACTUAL,2023-08-08,,INTERVENTIONAL,FALCON,Intent-to-Treat (ITT) population included all enrolled participants categorized by their randomized treatment group (whether or not they received study drug).,A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON,A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney Disease,TERMINATED,,PHASE3,667.0,ACTUAL,Biogen,"Due to discontinuation of all bardoxolone chronic kidney disease programs, study was terminated early.",3.0,,Discontinuation of all bardoxolone chronic kidney disease programs,f,,,,t,t,f,,,t,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,,,,,,2023,0.0
NCT02958865,,2016-11-04,2022-05-09,,2022-06-27,2016-11-04,2016-11-08,ESTIMATED,2022-06-27,2022-07-21,ACTUAL,,,,2022-06-27,2022-07-21,ACTUAL,2017-02-03,ACTUAL,2017-02-03,2022-06,2022-06-30,2021-05-10,ACTUAL,2021-05-10,2021-05-10,ACTUAL,2021-05-10,,INTERVENTIONAL,,"All randomized participants who received at least 1 dose of PF-06651600, PF-06700841, or placebo.","Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis","A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND CHRONIC THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS",COMPLETED,,PHASE2,319.0,ACTUAL,Pfizer,,10.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,INDUSTRY,,,,,,,2021,1.0
NCT02261883,,2013-10-30,2024-01-09,,2024-02-06,2014-10-06,2014-10-10,ESTIMATED,2024-02-06,2024-03-05,ACTUAL,,,,2024-02-06,2024-03-05,ACTUAL,2015-07-29,ACTUAL,2015-07-29,2024-02,2024-02-29,2023-05-17,ACTUAL,2023-05-17,2022-09-27,ACTUAL,2022-09-27,,INTERVENTIONAL,,Intent-to-Treat Population,Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn,"Intravenous Remodulin (Treprostinil) as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn: A Randomized, Placebo-Controlled, Safety and Efficacy Study",TERMINATED,,PHASE2,42.0,ACTUAL,United Therapeutics,,2.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,INDUSTRY,,,,,,,2023,0.0
NCT02857010,,2016-03-08,,,2024-02-27,2016-08-04,2016-08-05,ESTIMATED,,,,,,,2024-02-27,2024-02-28,ACTUAL,2016-02,ACTUAL,2016-02-29,2024-02,2024-02-29,2020-02,ACTUAL,2020-02-29,2018-02,ACTUAL,2018-02-28,,INTERVENTIONAL,Liveradvance,,Allogenic Bone Marrow Mesenchymal Stem Cell Therapy in Acute-on-chronic Liver Failure,Therapeutic Effects of Allogenic Mesenchymal Stem Cells in Cirrhotic Patients With Acute-on-chronic Liver Failure. A Double-blind Randomized Placebo-controlled Trial,TERMINATED,,PHASE1,23.0,ACTUAL,Hospital Clinic of Barcelona,,2.0,,Dificulties to recruit patients and dificulties to obtain MSCs.,f,,,,t,,,,,,,,,,,YES,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,OTHER,,,,,,,2020,0.0
NCT03036150,,2017-01-26,2021-04-19,,2021-06-15,2017-01-26,2017-01-30,ESTIMATED,2021-06-15,2021-07-07,ACTUAL,,,,2021-06-15,2021-07-07,ACTUAL,2017-02-02,ACTUAL,2017-02-02,2021-06,2021-06-30,2020-06-12,ACTUAL,2020-06-12,2020-06-12,ACTUAL,2020-06-12,,INTERVENTIONAL,Dapa-CKD,,A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease,A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease,COMPLETED,,PHASE3,4304.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,,,,,,2020,1.0
NCT04348656,,2020-04-13,2022-02-17,,2022-03-01,2020-04-13,2020-04-16,ACTUAL,2022-03-01,2022-03-03,ACTUAL,,,,2022-03-01,2022-03-03,ACTUAL,2020-03-14,ACTUAL,2020-03-14,2022-03,2022-03-31,2021-06-16,ACTUAL,2021-06-16,2021-03-05,ACTUAL,2021-03-05,,INTERVENTIONAL,CONCOR-1,,CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness (CONCOR-1),A Randomized Open-Label Trial of CONvalenscent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness (CONCOR-1),TERMINATED,,PHASE3,940.0,ACTUAL,McMaster University,,2.0,,Study was terminated after the planned interim analysis as the pre-defined futility threshold was met,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,OTHER,,,,,,,2021,0.0
NCT02792218,,2016-06-02,2020-09-18,2019-09-24,2021-09-03,2016-06-02,2016-06-07,ESTIMATED,2020-09-18,2020-10-19,ACTUAL,2019-09-24,2019-10-08,ACTUAL,2021-09-03,2021-10-01,ACTUAL,2016-09-20,ACTUAL,2016-09-20,2021-09,2021-09-30,2020-07-20,ACTUAL,2020-07-20,2019-07-05,ACTUAL,2019-07-05,,INTERVENTIONAL,ASCLEPIOS I,,Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis,"A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis",COMPLETED,,PHASE3,930.0,ACTUAL,Novartis,This study was not powered for the analysis of some secondary endpoints as a stand-alone study. It was pre-specified in the study protocol to combine the data with study COMB157G2302 to address these endpoints.,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,INDUSTRY,,,,,,,2020,1.0
NCT02845414,,2016-07-18,,,2018-10-01,2016-07-22,2016-07-27,ESTIMATED,,,,,,,2018-10-01,2018-10-03,ACTUAL,2018-12,ESTIMATED,2018-12-31,2018-10,2018-10-31,2022-01,ESTIMATED,2022-01-31,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,,,Study of CD133KDEL Toxin in the Treatment for Solid Tumors,Phase I Study Of Stem-Cell Directed Deimmunized CD133KDEL Toxin In The Treatment Of Solid Tumors,WITHDRAWN,,PHASE1,0.0,ACTUAL,"Masonic Cancer Center, University of Minnesota",,1.0,,Funding unavailable,f,,,,,t,f,,,,,,,,,,,2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,OTHER,,,,,,,2022,0.0
NCT03989531,,2019-06-17,,,2021-10-07,2019-06-17,2019-06-18,ACTUAL,,,,,,,2021-10-07,2021-10-08,ACTUAL,2019-04-04,ACTUAL,2019-04-04,2021-10,2021-10-31,2021-04-26,ACTUAL,2021-04-26,2021-04-26,ACTUAL,2021-04-26,,INTERVENTIONAL,ACCOST-HH,,Adrecizumab in Cardiogenic Shock,"Investigator-initiated, Placebo-controlled, Double-blind, Multi-center, Randomized Trial to Assess the Efficacy and Safety of Adrecizumab in Subjects With Cardiogenic Shock",COMPLETED,,PHASE2/PHASE3,150.0,ACTUAL,Universitätsklinikum Hamburg-Eppendorf,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 17:38:36.433892,2024-10-16 17:38:36.433892,OTHER,,,,,,,2021,0.0
NCT03481556,,2018-03-06,2022-11-08,,2022-12-14,2018-03-27,2018-03-29,ACTUAL,2022-12-14,2022-12-19,ACTUAL,,,,2022-12-14,2022-12-19,ACTUAL,2018-04-12,ACTUAL,2018-04-12,2022-12,2022-12-31,2022-02-02,ACTUAL,2022-02-02,2022-02-02,ACTUAL,2022-02-02,,INTERVENTIONAL,ANCHOR,"Participants included in the Safety Analysis Set were included in the Baseline Characteristics. The Safety Analysis Set includes all patients that have received at least 1 dose (or partial dose) of melflufen, dexamethasone, or partner therapy (bortezomib or daratumumab).",Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM,An Open-Label Phase 1/2a Study of the Safety and Efficacy of Melflufen and Dexamethasone in Combination With Either Bortezomib or Daratumumab in Patients With Relapsed or Relapsed-Refractory Multiple Myeloma,TERMINATED,,PHASE1/PHASE2,56.0,ACTUAL,Oncopeptides AB,"On 04 November 2021, the study was terminated early during Phase 2a.",2.0,,The sponsor decided to terminate the study following an FDA request of a partial clinical hold.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,,,,,,2022,0.0
NCT04126031,,2019-09-27,2023-12-30,,2024-02-27,2019-10-10,2019-10-14,ACTUAL,2024-02-27,2024-03-26,ACTUAL,,,,2024-02-27,2024-03-26,ACTUAL,2020-01-14,ACTUAL,2020-01-14,2024-02,2024-02-29,2022-12-30,ACTUAL,2022-12-30,2022-12-30,ACTUAL,2022-12-30,,INTERVENTIONAL,NOOR,Safety analysis sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part.,"Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.","A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CEFTAZIDIME AND AVIBACTAM IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 3 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT",TERMINATED,,PHASE2,48.0,ACTUAL,Pfizer,,2.0,,"Following regulatory consultation, the Sponsor has decided to terminate the study and analyze the current dataset. The decision to terminate was solely based on a business decision, not due to safety concerns.",f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,INDUSTRY,,,,,,,2022,0.0
NCT04456699,,2020-07-01,2024-03-08,,2024-07-26,2020-07-01,2020-07-02,ACTUAL,2024-03-08,2024-04-02,ACTUAL,,,,2024-07-26,2024-08-20,ACTUAL,2020-08-19,ACTUAL,2020-08-19,2024-07,2024-07-31,2023-11-06,ACTUAL,2023-11-06,2023-03-27,ACTUAL,2023-03-27,,INTERVENTIONAL,,,Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003),"A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction (LYNK-003)",COMPLETED,,PHASE3,335.0,ACTUAL,Merck Sharp & Dohme LLC,,3.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,INDUSTRY,,,,,,,2023,1.0
NCT04632537,,2020-11-04,,,2021-03-23,2020-11-16,2020-11-17,ACTUAL,,,,,,,2021-03-23,2021-03-26,ACTUAL,2020-12-07,ACTUAL,2020-12-07,2021-03,2021-03-31,2021-03-23,ACTUAL,2021-03-23,2021-03-23,ACTUAL,2021-03-23,,INTERVENTIONAL,NUEVA,,BCG Vaccination to Prevent COVID-19,Novel Use of an Existing Vaccine (BCG) Alliance: The NUEVA Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,Henry M. Jackson Foundation for the Advancement of Military Medicine,,2.0,,Due to funding - project never enrolled,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,OTHER,,,,,,,2021,0.0
NCT03591575,,2018-07-09,2024-02-08,,2024-03-13,2018-07-09,2018-07-19,ACTUAL,2024-03-13,2024-03-15,ACTUAL,,,,2024-03-13,2024-03-15,ACTUAL,2018-11-09,ACTUAL,2018-11-09,2024-03,2024-03-31,2020-09-29,ACTUAL,2020-09-29,2020-09-29,ACTUAL,2020-09-29,,INTERVENTIONAL,START,,Safety and Efficacy of Early Treatment With Deferiprone in Infants and Young Children,Safety and Efficacy of Early-start Deferiprone Treatment in Infants and Young Children Newly Diagnosed With Transfusion-dependent Beta Thalassemia,COMPLETED,,PHASE4,64.0,ACTUAL,Chiesi Canada Corp,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,INDUSTRY,,,,,,,2020,1.0
NCT03803202,,2019-01-11,2023-09-27,2021-09-27,2023-11-30,2019-01-11,2019-01-14,ACTUAL,2023-11-30,2023-12-21,ACTUAL,,2023-12-21,ACTUAL,2023-11-30,2023-12-21,ACTUAL,2019-01-24,ACTUAL,2019-01-24,2023-11,2023-11-30,2020-09-28,ACTUAL,2020-09-28,2020-09-28,ACTUAL,2020-09-28,,INTERVENTIONAL,,,"A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine","A Phase 1/2, Randomized, Single Ascending Dose Study in Adults (Stage 1) and Randomized, Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, a Pneumococcal Vaccine",COMPLETED,,PHASE1/PHASE2,630.0,ACTUAL,GlaxoSmithKline,,9.0,,,f,,,,f,t,f,,,,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://www.clinicalstudydatarequest.com/,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,INDUSTRY,,,,,,,2020,1.0
NCT03449134,,2018-02-22,2021-05-07,,2021-06-15,2018-02-22,2018-02-28,ACTUAL,2021-06-15,2021-06-16,ACTUAL,,,,2021-06-15,2021-06-16,ACTUAL,2018-03-14,ACTUAL,2018-03-14,2021-06,2021-06-30,2020-08-17,ACTUAL,2020-08-17,2020-06-05,ACTUAL,2020-06-05,,INTERVENTIONAL,,,A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027),"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN027)",COMPLETED,,PHASE3,732.0,ACTUAL,Merck Sharp & Dohme LLC,,3.0,,,,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,,,,,,2020,1.0
NCT04016714,,2019-07-10,2022-09-30,,2023-05-02,2019-07-10,2019-07-11,ACTUAL,2022-11-11,2022-12-01,ACTUAL,,,,2023-05-02,2023-05-06,ACTUAL,2019-08-28,ACTUAL,2019-08-28,2023-05,2023-05-31,2021-10-29,ACTUAL,2021-10-29,2021-10-29,ACTUAL,2021-10-29,,INTERVENTIONAL,PNEU-PED-EU-2,,"Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2/V114-026)","A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2)",COMPLETED,,PHASE3,1191.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,t,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,INDUSTRY,,,,,,,2021,1.0
NCT02586012,,2015-10-22,2020-09-01,,2020-09-23,2015-10-23,2015-10-26,ESTIMATED,2020-09-23,2020-09-25,ACTUAL,,,,2020-09-23,2020-09-25,ACTUAL,2015-09,ACTUAL,2015-09-30,2020-09,2020-09-30,2020-01-10,ACTUAL,2020-01-10,2020-01-10,ACTUAL,2020-01-10,,INTERVENTIONAL,,,Weight-based Dosing in Hemophilia A,"Weight-based Dosing in Hemophilia A: A Randomized, Controlled, Open-label, Crossover Trial to Measure Factor VIII Recovery Following Factor VIII Concentrate Dosing Based on Total Body Weight, Ideal Body Weight, and Lean Body Mass",TERMINATED,,PHASE2,30.0,ACTUAL,University of Pittsburgh,Early termination due to poor enrollment prior to 24 subjects successfully completing the study.~The rFVIII dose was erroneously calculated in 7 subjects resulting in the administration of a smaller than intended amount.,6.0,,Insufficient enrollment,f,,,,t,,,,,,,,,,,NO,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,OTHER,,,,,,,2020,0.0
NCT03845075,,2019-01-30,2022-06-20,,2024-02-09,2019-02-18,2019-02-19,ACTUAL,2024-02-09,2024-02-13,ACTUAL,,,,2024-02-09,2024-02-13,ACTUAL,2019-02-25,ACTUAL,2019-02-25,2024-02,2024-02-29,2020-10-16,ACTUAL,2020-10-16,2020-10-16,ACTUAL,2020-10-16,,INTERVENTIONAL,,,"48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO)","A 24-week Phase 2, Double-blind, Randomized, Placebo- Controlled, Single-center Safety and Efficacy Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO), and With a 24-week Open-label Extension, in Total 48 Weeks",COMPLETED,,PHASE2,21.0,ACTUAL,Saniona,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,,,,,,2020,1.0
NCT01485861,,2011-12-02,2023-08-17,,2023-08-17,2011-12-02,2011-12-06,ESTIMATED,2023-08-17,2023-09-14,ACTUAL,,,,2023-08-17,2023-09-14,ACTUAL,2012-01-11,ACTUAL,2012-01-11,2023-08,2023-08-31,2022-08-31,ACTUAL,2022-08-31,2015-09-01,ACTUAL,2015-09-01,,INTERVENTIONAL,,Intent-To-Treat (ITT) Population included all participants allocated to the treatment arm according to randomization.,Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy,A Phase Ib/II Study of Ipatasertib (GDC-0068) or Apitolisib (GDC-0980) With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy,COMPLETED,,PHASE1/PHASE2,298.0,ACTUAL,"Genentech, Inc.",,6.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,INDUSTRY,,,,,,,2022,1.0
NCT02507687,,2015-07-22,2024-03-18,2022-11-01,2024-04-16,2015-07-23,2015-07-24,ESTIMATED,2024-04-16,2024-05-10,ACTUAL,2022-11-01,2022-11-04,ACTUAL,2024-04-16,2024-05-10,ACTUAL,2015-08-27,ACTUAL,2015-08-27,2024-04,2024-04-30,2023-05-31,ACTUAL,2023-05-31,2021-11-24,ACTUAL,2021-11-24,,INTERVENTIONAL,,,Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults With Open-Angle Glaucoma or Ocular Hypertension,A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension,COMPLETED,,PHASE3,240.0,ACTUAL,AbbVie,,4.0,,,t,,,,f,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,NCT05338606,AVAILABLE,,,,2023,1.0
NCT03982173,,2019-06-07,,,2023-01-24,2019-06-07,2019-06-11,ACTUAL,,,,,,,2023-01-24,2023-01-26,ACTUAL,2020-09,ESTIMATED,2020-09-30,2023-01,2023-01-31,2024-12-05,ESTIMATED,2024-12-05,2024-09,ESTIMATED,2024-09-30,,INTERVENTIONAL,MATILDA,,Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors,A Phase II Whole Exome Sequencing-based Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Gustave Roussy, Cancer Campus, Grand Paris",,1.0,,"Similar clinical trials showed not very encouraging results, which made us decide, after several modifications to the protocol and numerous difficulties encountered, to abandon the trial.",f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,OTHER,,,,,,,2024,0.0
NCT02853305,,2016-07-29,2021-04-28,,2023-08-14,2016-07-29,2016-08-02,ESTIMATED,2021-04-28,2021-05-20,ACTUAL,,,,2023-08-14,2023-09-08,ACTUAL,2016-09-15,ACTUAL,2016-09-15,2023-08,2023-08-31,2022-09-15,ACTUAL,2022-09-15,2020-04-29,ACTUAL,2020-04-29,,INTERVENTIONAL,,,Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361),"A Phase III Randomized, Controlled Clinical Trial of Pembrolizumab With or Without Platinum-Based Combination Chemotherapy Versus Chemotherapy in Subjects With Advanced or Metastatic Urothelial Carcinoma",COMPLETED,,PHASE3,1010.0,ACTUAL,Merck Sharp & Dohme LLC,,3.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,,,,,,2022,1.0
NCT03041701,,2017-02-02,2022-03-17,,2022-03-17,2017-02-02,2017-02-03,ESTIMATED,2022-03-17,2022-04-14,ACTUAL,,,,2022-03-17,2022-04-14,ACTUAL,2017-07-07,ACTUAL,2017-07-07,2022-03,2022-03-31,2021-10-16,ACTUAL,2021-10-16,2021-09-15,ACTUAL,2021-09-15,,INTERVENTIONAL,,,Insulin-like Growth Factor 1 Receptor (IGF-1R) Antibody AMG479 (Ganitumab) in Combination With the Src Family Kinase (SFK) Inhibitor Dasatinib in People With Embryonal and Alveolar Rhabdomyosarcoma,A Phase I/II Trial of the Insulin-Like Growth Factor 1 Receptor (IGF-1R) Antibody AMG479 (Ganitumab) in Combination With the Src Family Kinase (SFK) Inhibitor Dasatinib in Patients With Embryonal and Alveolar Rhabdomyosarcoma,TERMINATED,,PHASE1/PHASE2,14.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,The pharmaceutical company discontinued availability of the drug and we were forced to close the study before phase II was completed. Only one participant was enrolled on phase II.,f,,,,f,t,f,,,,,,Clinical data will be made available via subscription to the Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).,"Clinical data will be made available via subscription to the Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Requests for all collected individual participant data (IPD) data from clinical trials, conducted under a binding collaborative agreement between National Cancer Institute (NCI)/Division of Cancer Treatment and Diagnosis (DCTD) and a pharmaceutical/biotechnology company, that are not under data safety monitoring board (DSMB) monitoring must be in compliance with the terms of the binding collaborative agreement and must be approved by NCI/DCTD and the Pharmaceutical Collaborator (i.e., the NCI Experimental Therapeutics Clinical Trials Network (ETCTN) Director in conjunction with the NCI/DCTD Regulatory Affairs Branch).",,YES,Clinical data available during the study and indefinitely.,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,NIH,,,,,,,2021,0.0
NCT04531579,,2020-08-21,,,2021-10-27,2020-08-26,2020-08-28,ACTUAL,,,,,,,2021-10-27,2021-10-29,ACTUAL,2022-01,ESTIMATED,2022-01-31,2021-10,2021-10-31,2023-06,ESTIMATED,2023-06-30,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,Valproic Acid (VPA) for Acute Kidney Injury (AKI) in Trauma Patients,Evaluation of Valproic Acid (VPA) as Adjunctive Therapy for Trauma Patients With Moderate to Severe Hemorrhage at Risk of Ischemia Reperfusion (I/R) Injury,WITHDRAWN,,PHASE2,0.0,ACTUAL,Westat,,2.0,,Study terminated by the Sponsor.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,OTHER,,,,,,,2023,0.0
NCT02466568,,2015-06-05,,,2019-09-06,2015-06-05,2015-06-09,ESTIMATED,,,,,,,2019-09-06,2019-09-09,ACTUAL,2018-07,ESTIMATED,2018-07-31,2019-09,2019-09-30,2020-07,ESTIMATED,2020-07-31,2019-07,ESTIMATED,2019-07-31,,INTERVENTIONAL,,,Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung,A Randomized Phase I/II Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,2.0,,Funding unavailable,f,,,,f,t,f,,,,,,,,,,,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,OTHER,,,,,,,2020,0.0
NCT04082481,,2019-09-05,,,2021-11-23,2019-09-05,2019-09-09,ACTUAL,,,,,,,2021-11-23,2021-11-26,ACTUAL,2021-11-17,ESTIMATED,2021-11-17,2021-11,2021-11-30,2022-04-29,ESTIMATED,2022-04-29,2022-04-29,ESTIMATED,2022-04-29,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-988 in Healthy Participants","A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-988 in Healthy Subjects",WITHDRAWN,,PHASE1,0.0,ACTUAL,Takeda,,5.0,,"The study stopped early, before enrolling its first participant.",f,,,,f,t,f,,,,,,,,,YES,"Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,,,,,,2022,0.0
NCT03781414,,2018-12-18,2024-03-19,,2024-07-01,2018-12-18,2018-12-19,ACTUAL,2024-07-01,2024-07-03,ACTUAL,,,,2024-07-01,2024-07-03,ACTUAL,2019-10-07,ACTUAL,2019-10-07,2024-07,2024-07-31,2023-04-20,ACTUAL,2023-04-20,2023-04-20,ACTUAL,2023-04-20,,INTERVENTIONAL,CONTRAIL I,,"Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension","A 12-month, Open-label, Multicenter, Randomized, Safety, Efficacy, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Two Regimens of Anti-CD40 Monoclonal Antibody, CFZ533 vs. Standard of Care Control, in Adult de Novo Liver Transplant Recipients With a 12-month Additionalr Follow-up and a Long-term Extension (CONTRAIL I)",TERMINATED,,PHASE2,128.0,ACTUAL,Novartis,,3.0,,The study was terminated following less favorable efficacy by Iscalimab (CFZ533) in liver transplant patients compared to tacrolimus.,f,,,,t,t,f,,,,,,,,,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,INDUSTRY,,,,,,,2023,0.0
NCT05614245,,2022-11-02,,,2023-03-30,2022-11-10,2022-11-14,ACTUAL,,,,,,,2023-03-30,2023-04-04,ACTUAL,2023-03,ESTIMATED,2023-03-31,2023-03,2023-03-31,2024-06,ESTIMATED,2024-06-30,2024-06,ESTIMATED,2024-06-30,,INTERVENTIONAL,,,"Safety, Tolerability, and Immunogenicity of Trivalent Coronavirus Vaccine Candidate VBI-2901e With E6020 Adjuvant","A Phase 1, Open-Label, Adjuvant Dose-Escalation, Randomized Study to Evaluate the Safety and Immunogenicity of VBI-2901e, a Trivalent Coronavirus Vaccine Candidate Adjuvanted With Aluminum Phosphate and E6020 in Healthy Adults Previously Vaccinated With Licensed COVID-19 Vaccines",WITHDRAWN,,PHASE1,0.0,ACTUAL,VBI Vaccines Inc.,,6.0,,Study was halted prematurely prior to enrollment of first participant based on study sponsor's decision to prioritize clinical development of VBI-2901a.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,INDUSTRY,,,,,,,2024,0.0
NCT03631654,,2018-08-03,,,2021-12-15,2018-08-14,2018-08-15,ACTUAL,,,,,,,2021-12-15,2022-01-05,ACTUAL,2020-10-01,ESTIMATED,2020-10-01,2021-12,2021-12-31,2021-08-31,ACTUAL,2021-08-31,2021-08-31,ACTUAL,2021-08-31,,INTERVENTIONAL,,,Ivabradine in Stage D Heart Failure Patients on Chronic Inotropes,Ivabradine in Stage D Heart Failure Patients on Chronic Inotropes: A Pilot Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of Maryland, Baltimore",,2.0,,Unable to obtain funding,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,OTHER,,,,,,,2021,0.0
NCT02759120,,2016-04-28,2020-12-22,,2021-03-11,2016-04-28,2016-05-03,ESTIMATED,2021-02-09,2021-03-03,ACTUAL,,,,2021-03-11,2021-04-08,ACTUAL,2017-03-22,ACTUAL,2017-03-22,2021-03,2021-03-31,2020-03-16,ACTUAL,2020-03-16,2020-03-16,ACTUAL,2020-03-16,,INTERVENTIONAL,CleanUp-IPF,,CleanUP IPF for the Pulmonary Trials Cooperative,Study of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary Fibrosis,TERMINATED,,PHASE3,513.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,Terminated for futility after review of first planned interim analysis.,f,,,,t,t,f,,,f,,,Within a year of the primary paper publication and then indefinitely maintained by BioLINCC,The data will be open access for interested investigators,https://biolincc.nhlbi.nih.gov/home/,YES,All collected IPD will be uploaded in a de-identified manner into BioLINCC with open access for interested investigators,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,OTHER,,,,,,,2020,0.0
NCT04600921,,2020-10-19,,,2023-10-18,2020-10-19,2020-10-23,ACTUAL,,,,,,,2023-10-18,2023-10-23,ACTUAL,2021-06-24,ACTUAL,2021-06-24,2023-10,2023-10-31,2023-10-18,ACTUAL,2023-10-18,2023-06-23,ACTUAL,2023-06-23,,INTERVENTIONAL,ERASE,,Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study,Ertugliflozin to Reduce Arrhythmic Burden in Implantable Cardioverter-defibrillators (ICD)/Cardiac Resynchronisation Therapy(CRT) patientS (ERASe-Trial) - a Phase III Study,TERMINATED,,PHASE3,55.0,ACTUAL,Medical University of Graz,,2.0,,The feasibility (recruitment) of the high number of patients (402 patients with HFrEF or HFmrEF) was impossible due to the rapid increase in SGLT2 inhibitors in patients with heart failure.,f,,,,t,f,f,,,,,,,,,,,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,OTHER,,,,,,,2023,0.0
NCT05101486,,2021-10-29,2023-08-15,2023-03-24,2023-10-11,2021-10-29,2021-11-01,ACTUAL,2023-08-15,2023-09-06,ACTUAL,,2023-03-30,ACTUAL,2023-10-11,2023-10-13,ACTUAL,2021-11-01,ACTUAL,2021-11-01,2023-10,2023-10-31,2022-09-20,ACTUAL,2022-09-20,2022-03-28,ACTUAL,2022-03-28,,INTERVENTIONAL,,"The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.",A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years,"A Randomized, Double-blind Phase 3 Study to Assess the Immunogenicity and Safety of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years",COMPLETED,,PHASE3,755.0,ACTUAL,Janssen Vaccines & Prevention B.V.,,3.0,,,f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,INDUSTRY,,,,,,,2022,1.0
NCT05804162,,2023-03-27,,,2023-10-27,2023-03-27,2023-04-07,ACTUAL,,,,,,,2023-10-27,2023-10-30,ACTUAL,2023-04-12,ACTUAL,2023-04-12,2023-10,2023-10-31,2023-09-18,ACTUAL,2023-09-18,2023-09-18,ACTUAL,2023-09-18,,INTERVENTIONAL,,,A Research Study Looking at How Cagrilintide Works on the Heart Rhythm in Healthy Participants,A Thorough QTc Study Evaluating the Effect of Cagrilintide on Cardiac Repolarisation in Healthy Participants,COMPLETED,,PHASE1,107.0,ACTUAL,Novo Nordisk A/S,,3.0,,,f,,,,f,f,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,,,,,,2023,1.0
NCT03643562,,2018-08-19,2023-11-17,2022-10-07,2023-12-22,2018-08-19,2018-08-23,ACTUAL,2023-12-22,2024-01-17,ACTUAL,,2024-01-17,ACTUAL,2023-12-22,2024-01-17,ACTUAL,2018-06-18,ACTUAL,2018-06-18,2023-12,2023-12-31,2021-11-02,ACTUAL,2021-11-02,2021-11-02,ACTUAL,2021-11-02,,INTERVENTIONAL,,All enrolled participants,Niemann-Pick Type C Treatment With Adrabetadex for Symptoms of Brain and Nervous System,Open-label Evaluation of Adrabetadex in Patients With Neurologic Manifestations of Niemann-Pick Type C Disease (NPC),TERMINATED,,PHASE3,27.0,ACTUAL,Mandos LLC,This study was terminated early when the Sponsor had determined that the benefit-risk profile of adrabetadex was not favorable and the clinical development program for adrabetadex was discontinued.,1.0,,Sponsor had determined that the benefit-risk profile of adrabetadex was not favorable and the clinical development program for adrabetadex was discontinued.,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,INDUSTRY,,,,,,,2021,0.0
NCT02947581,,2016-10-24,,,2022-11-11,2016-10-25,2016-10-28,ESTIMATED,,,,,,,2022-11-11,2022-11-16,ACTUAL,2016-11-14,ACTUAL,2016-11-14,2022-11,2022-11-30,2021-02-27,ACTUAL,2021-02-27,2020-08-21,ACTUAL,2020-08-21,,INTERVENTIONAL,SANTO,,Sub Arachnoid Neurocysticercosis Treatment Outcome (SANTO),A Randomized Trial of Combined Albendazole Plus Praziquantel for Subarachnoid Cysticercosis of the Sylvian Fissure or the Basal Cisterns,TERMINATED,,PHASE3,107.0,ACTUAL,Universidad Peruana Cayetano Heredia,,2.0,,"Albendazole and albendazole placebo are not available in our local suppliers or in the international market. Consequently, it is no possible to re-initiate the enrollment to complete the original sample size.",f,,,,t,,,,,,,,"Available: December 2021, until December 2023",The information will be shared upon requested by interested researchers,,YES,Anonymized patient data will be shared upon request and review by the project leaders.,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,OTHER,,,,,,,2021,0.0
NCT05044234,,2021-09-07,2023-11-06,,2023-11-06,2021-09-07,2021-09-14,ACTUAL,2023-11-06,2023-11-29,ACTUAL,,,,2023-11-06,2023-11-29,ACTUAL,2021-11-16,ACTUAL,2021-11-16,2023-11,2023-11-30,2022-11-30,ACTUAL,2022-11-30,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,,ITT population: all randomized participants,A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis,"A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Cedirogant (ABBV-157) in Adult Subjects With Moderate to Severe Psoriasis",TERMINATED,,PHASE2,156.0,ACTUAL,AbbVie,,4.0,,Company Decision,f,,,,t,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,INDUSTRY,,,,,,,2022,0.0
NCT04082936,,2019-09-04,,,2024-07-23,2019-09-05,2019-09-10,ACTUAL,,,,,,,2024-07-23,2024-07-24,ACTUAL,2019-09-30,ACTUAL,2019-09-30,2024-07,2024-07-31,2024-02-22,ACTUAL,2024-02-22,2024-02-16,ACTUAL,2024-02-16,,INTERVENTIONAL,,,A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma,"A Phase 1/2 Open-label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Imvotamab (IGM-2323) as a Single Agent and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphomas",TERMINATED,,PHASE1/PHASE2,97.0,ACTUAL,"IGM Biosciences, Inc.",,6.0,,Strategic Pipeline Prioritization: Clinical development of imvotamab in autoimmune diseases prioritized.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,INDUSTRY,,,,,,,2024,0.0
NCT05261126,,2022-02-22,2023-11-15,,2024-07-29,2022-02-22,2022-03-02,ACTUAL,2023-11-15,2023-12-06,ACTUAL,,,,2024-07-29,2024-08-20,ACTUAL,2022-03-10,ACTUAL,2022-03-10,2024-07,2024-07-31,2022-11-28,ACTUAL,2022-11-28,2022-11-28,ACTUAL,2022-11-28,,INTERVENTIONAL,,,A Study of the Efficacy and Safety of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008),"A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia",COMPLETED,,PHASE2,381.0,ACTUAL,Merck Sharp & Dohme LLC,,5.0,,,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,INDUSTRY,,,,,,,2022,1.0
NCT05497934,,2022-08-10,,,2024-08-19,2022-08-10,2022-08-11,ACTUAL,,,,,,,2024-08-19,2024-08-21,ACTUAL,2022-10-01,ESTIMATED,2022-10-01,2024-08,2024-08-31,2024-03-31,ESTIMATED,2024-03-31,2023-10-01,ESTIMATED,2023-10-01,,INTERVENTIONAL,,,The Effects of Glycerol as an Optical Clearing Agent for Visualization of the Middle Ear,The Effects of Glycerol as an Optical Clearing Agent for Visualization of the Middle Ear,WITHDRAWN,,PHASE1,0.0,ACTUAL,Nova Scotia Health Authority,,1.0,,No response from initial letter or expiry email- closed by REB office,f,,,,f,f,f,,,f,,,,,,NO,Results of trial will be published in a journal article,2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,OTHER,,,,,,,2024,0.0
NCT05239598,,2022-02-14,2023-06-01,,2023-07-20,2022-02-14,2022-02-15,ACTUAL,2023-07-20,2023-08-14,ACTUAL,,,,2023-07-20,2023-08-14,ACTUAL,2022-02-07,ACTUAL,2022-02-07,2023-07,2023-07-31,2022-07-13,ACTUAL,2022-07-13,2022-07-07,ACTUAL,2022-07-07,,INTERVENTIONAL,,,Povidone-Iodine Oral Rinse Study,"A Phase II, Randomized Trial to Test the Effect of Povidone-iodine 0.5% as Mouthwash/Gargle on SARS-CoV-2 Load (COVID 19) as an Adjuvant Infection Control Measure in Dental Practice",COMPLETED,,PHASE2,40.0,ACTUAL,University of Pennsylvania,"Our findings suggest that RT-PCR quantification of Ct viral targets present some limitations but can be of clinical utility. RT-PCR methods are inherently quantitative, and reproducible during repeated clinical sampling over a short time period. A limitation of our study was that changes in viral targets (RT-PCR) was determined after a one-time use of the mouthwash; prolonged use might yield better efficacy.",2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,OTHER,,,,,,,2022,1.0
NCT02624869,,2015-10-22,2021-11-15,,2024-05-10,2015-12-04,2015-12-09,ESTIMATED,2021-12-16,2022-01-14,ACTUAL,,,,2024-05-10,2024-05-29,ACTUAL,2016-09-10,ACTUAL,2016-09-10,2024-05,2024-05-31,2021-06-01,ACTUAL,2021-06-01,2021-06-01,ACTUAL,2021-06-01,,INTERVENTIONAL,HAUSER-OLE,All enrolled participants,"Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)","Open-label, Single-Arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH)",COMPLETED,,PHASE3,163.0,ACTUAL,Amgen,,1.0,,,f,,,,t,,,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,,,,,,2021,1.0
NCT05215418,,2022-01-17,2024-04-30,2024-04-09,2024-06-21,2022-01-17,2022-01-31,ACTUAL,2024-05-23,2024-06-18,ACTUAL,,2024-06-18,ACTUAL,2024-06-21,2024-07-17,ACTUAL,2022-01-25,ACTUAL,2022-01-25,2024-06,2024-06-30,2023-04-17,ACTUAL,2023-04-17,2023-04-11,ACTUAL,2023-04-11,,INTERVENTIONAL,,,A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects,"A Multicenter, Randomized, Double-Blind Study to Compare the Effects of VI-0521,Phentermine, and Placebo on Ambulatory Blood Pressure in Overweight or Obese Subjects",COMPLETED,,PHASE4,565.0,ACTUAL,VIVUS LLC,"Participants with baseline blood pressure greater than 140/90 were excluded. Of the 565 total participants randomized and treated with study drug, 180 participants were excluded from the per protocol population used for the primary analysis due to participants' reluctance or inability to properly complete end of study ABPM assessments.",3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,,,,,,2023,1.0
NCT03801265,,2019-01-09,2021-05-30,,2021-06-24,2019-01-09,2019-01-11,ACTUAL,2021-06-24,2021-07-15,ACTUAL,,,,2021-06-24,2021-07-15,ACTUAL,2019-03-19,ACTUAL,2019-03-19,2021-06,2021-06-30,2020-05-30,ACTUAL,2020-05-30,2020-05-30,ACTUAL,2020-05-30,,INTERVENTIONAL,,,Lumbar Plexus vs Quadratus Lumborum Block in Post-operative Pain Following Total Hip Replacement,"A Prospective, Randomized, Double-blinded, Active-comparator, Non-inferiority Study to Observe Relative Efficacy of Ultrasound-guided Transmuscular Quadratus Lumborum Block Versus Class Lumbar Plexus Block in Managing Post-operative Pain Following Total Hip Replacement Surgery",COMPLETED,,PHASE4,46.0,ACTUAL,University of Pittsburgh,"The study was conducted at a single-center, potentially confounding external validity. Though the desired statistical power was achieved, our sample was still small. More non-inferiority studies are needed to confirm our results.",2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,OTHER,,,,,,,2020,1.0
NCT02590523,,2015-10-27,,,2022-04-20,2015-10-27,2015-10-29,ESTIMATED,,,,,,,2022-04-20,2022-04-27,ACTUAL,2023-01,ESTIMATED,2023-01-31,2022-04,2022-04-30,2024-01,ESTIMATED,2024-01-31,2024-01,ESTIMATED,2024-01-31,,INTERVENTIONAL,,,Intracameral Antibiotic Safety Study,Intracameral Antibiotic Safety Study,SUSPENDED,,PHASE3,500.0,ESTIMATED,"Panhandle Eye Group, LLP",,3.0,,Lack of antibiotic availability,f,,,,f,t,f,,,,,,,,,,,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,OTHER,,,,,,,2024,0.0
NCT02987998,,2016-12-07,,,2022-12-15,2016-12-07,2016-12-09,ESTIMATED,,,,,,,2022-12-15,2022-12-19,ACTUAL,2017-05-19,ACTUAL,2017-05-19,2022-12,2022-12-31,2022-11-28,ACTUAL,2022-11-28,2022-11-28,ACTUAL,2022-11-28,,INTERVENTIONAL,,,Neoadjuvant Chemoradiation Plus Pembrolizumab Followed By Consolidation Pembrolizumab in NSCLC,A Phase I Safety and Feasibility Study of Neoadjuvant Chemoradiation Plus Pembrolizumab Followed By Consolidation Pembrolizumab in Resectable Stage 3A Non-Small Cell Lung Cancer,TERMINATED,,PHASE1,9.0,ACTUAL,Case Comprehensive Cancer Center,,1.0,,higher than expected rate of toxicity \& unrealistic timeline to complete trial under company's proposed plan to reopen,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,OTHER,,,,,,,2022,0.0
NCT02774681,,2016-05-13,2020-02-10,,2020-04-02,2016-05-13,2016-05-17,ESTIMATED,2020-02-10,2020-02-24,ACTUAL,,,,2020-04-02,2020-04-14,ACTUAL,2016-08-31,ACTUAL,2016-08-31,2020-04,2020-04-30,2020-02-16,ACTUAL,2020-02-16,2019-02-13,ACTUAL,2019-02-13,,INTERVENTIONAL,,,Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis,A Phase II Single Arm Study of Palbociclib in Patients With Metastatic HER2-positive Breast Cancer With Brain Metastasis,TERMINATED,,PHASE2,12.0,ACTUAL,Northwestern University,The study was closed before the accrual goal was met due to slow accrual.,1.0,,Slow accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,OTHER,,,,,,,2020,0.0
NCT04530877,,2020-08-24,,,2022-08-05,2020-08-25,2020-08-28,ACTUAL,,,,,,,2022-08-05,2022-08-09,ACTUAL,2022-10-01,ESTIMATED,2022-10-01,2022-08,2022-08-31,2024-09-30,ESTIMATED,2024-09-30,2024-09-30,ESTIMATED,2024-09-30,,INTERVENTIONAL,,,Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients,Comparative Effectiveness of Exclusive Enteral Nutrition and Infliximab in Chinese Children With Active Crohn's Disease,WITHDRAWN,,PHASE4,0.0,ACTUAL,Children's Hospital of Fudan University,,2.0,,no funding,f,,,,,f,f,,,,,,,,,,,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,OTHER,,,,,,,2024,0.0
NCT03837353,,2019-01-22,2023-07-19,,2023-12-12,2019-02-08,2019-02-12,ACTUAL,2023-12-12,2023-12-18,ACTUAL,,,,2023-12-12,2023-12-18,ACTUAL,2019-04-01,ACTUAL,2019-04-01,2023-12,2023-12-31,2022-09-20,ACTUAL,2022-09-20,2022-07-19,ACTUAL,2022-07-19,,INTERVENTIONAL,,,A Parallel Arm Phase 1b/2a Study of DKN-01 as Monotherapy or in Combination With Docetaxel for the Treatment of Advanced Prostate Cancer With Elevated DKK1,A Parallel Arm Phase 1b/2a Study of DKN-01 as Monotherapy or in Combination With Docetaxel for the Treatment of Advanced Prostate Cancer With Elevated DKK1,TERMINATED,,PHASE1/PHASE2,18.0,ACTUAL,NYU Langone Health,,4.0,,Terminated early due to slow accrual in the context of changing practice patterns.,f,,,,t,t,f,,,,,,Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.,The investigator who proposed to use the data.,,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).",2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,OTHER,,,,,,,2022,0.0
NCT02987959,,2016-12-02,2020-08-07,,2022-09-19,2016-12-07,2016-12-09,ESTIMATED,2021-02-08,2021-02-24,ACTUAL,,,,2022-09-19,2022-10-14,ACTUAL,2017-02-21,ACTUAL,2017-02-21,2022-09,2022-09-30,2020-07-24,ACTUAL,2020-07-24,2019-01-30,ACTUAL,2019-01-30,,INTERVENTIONAL,,,Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas,Phase II Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas With Dysregulation of the mTOR Pathway,TERMINATED,,PHASE2,6.0,ACTUAL,Fox Chase Cancer Center,,1.0,,Closed to accrual due to Funding Sponsor withdrawing support due to low accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,OTHER,,,,,,,2020,0.0
NCT04661514,,2020-11-19,,,2022-07-22,2020-12-03,2020-12-10,ACTUAL,,,,,,,2022-07-22,2022-07-25,ACTUAL,2021-05-01,ACTUAL,2021-05-01,2022-07,2022-07-31,2022-06-10,ACTUAL,2022-06-10,2022-03-10,ACTUAL,2022-03-10,,INTERVENTIONAL,,,Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy,Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy,COMPLETED,,PHASE2,16.0,ACTUAL,"University of California, San Diego",,1.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,OTHER,,,,,,,2022,1.0
NCT05181540,,2021-12-16,,,2024-01-24,2021-12-16,2022-01-06,ACTUAL,,,,,,,2024-01-24,2024-01-25,ACTUAL,2022-02-21,ACTUAL,2022-02-21,2024-01,2024-01-31,2024-01-24,ACTUAL,2024-01-24,2023-12-29,ACTUAL,2023-12-29,,INTERVENTIONAL,E-CELERATE,,A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation,"A Phase 3 Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of AB-205 Plus Standard of Care Versus Placebo Plus Standard of Care in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT) (E-CELERATE)",TERMINATED,,PHASE3,130.0,ACTUAL,Angiocrine Bioscience,,2.0,,Interim analysis showed lack of efficacy,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,INDUSTRY,,,,,,,2024,0.0
NCT04280588,,2020-02-20,,,2020-11-11,2020-02-20,2020-02-21,ACTUAL,,,,,,,2020-11-11,2020-11-13,ACTUAL,2020-02-22,ESTIMATED,2020-02-22,2020-11,2020-11-30,2020-07-01,ESTIMATED,2020-07-01,2020-07-01,ESTIMATED,2020-07-01,,INTERVENTIONAL,,,Fingolimod in COVID-19,Efficacy of Fingolimod in the Treatment of New Coronavirus Pneumonia (COVID-19),WITHDRAWN,,PHASE2,0.0,ACTUAL,First Affiliated Hospital of Fujian Medical University,,2.0,,No participants enrolled,f,,,,f,f,f,,,,,,,,,YES,,2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,OTHER,,,,,,,2020,0.0
NCT05016622,,2021-08-16,2024-04-12,,2024-07-05,2021-08-16,2021-08-23,ACTUAL,2024-07-05,2024-07-31,ACTUAL,,,,2024-07-05,2024-07-31,ACTUAL,2021-08-10,ACTUAL,2021-08-10,2024-07,2024-07-31,2023-05-21,ACTUAL,2023-05-21,2022-04-20,ACTUAL,2022-04-20,,INTERVENTIONAL,,106 participants were enrolled into the study.,Booster Dose Trial,Safety and Efficacy of Booster Doses of COVID-19 Vaccine in Immunocompromised Patients With a Cancer Diagnosis,TERMINATED,,PHASE2,106.0,ACTUAL,Montefiore Medical Center,,1.0,,"Due to decreased level of engagement and available funding, PI determined it appropriate to close the study prior to visit occurring. IRB approved.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,OTHER,,,,,,,2023,0.0
NCT05363605,,2022-04-26,,,2023-12-13,2022-05-03,2022-05-06,ACTUAL,,,,,,,2023-12-13,2023-12-19,ACTUAL,2022-04-20,ACTUAL,2022-04-20,2023-12,2023-12-31,2023-09-08,ACTUAL,2023-09-08,2023-09-08,ACTUAL,2023-09-08,,INTERVENTIONAL,,,A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours,"A Phase 1/2 Study of [225Ac]-FPI-1966, [111In]-FPI-1967, and Vofatamab in Participants With FGFR3-expressing Advanced, Inoperable, Metastatic and/or Recurrent Solid Tumours",TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,Fusion Pharmaceuticals Inc.,,2.0,,Fusion announced that it is discontinuing this study as part of a portfolio prioritization and assessment; Fusion no longer plans to pursue development of FPI-1966.,f,,,,,t,f,,,,,,,,,,,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,,,,,,2023,0.0
NCT03311126,,2017-09-28,,,2024-01-23,2017-10-10,2017-10-16,ACTUAL,,,,,,,2024-01-23,2024-01-25,ACTUAL,2017-10-19,ACTUAL,2017-10-19,2024-01,2024-01-31,2023-07-31,ACTUAL,2023-07-31,2023-07-31,ACTUAL,2023-07-31,,INTERVENTIONAL,,,Bendamustine + Obinutuzumab Induction With Obinutuzumab Maintenance in Untreated Mantle Cell Lymphoma,Bendamustine + Obinutuzumab Induction Chemoimmunotherapy With Risk-adapted Obinutuzumab Maintenance Therapy in Previously Untreated Mantle Cell Lymphoma,TERMINATED,,PHASE2,21.0,ACTUAL,"University of Wisconsin, Madison",,1.0,,slow accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,OTHER,,,,,,,2023,0.0
NCT04733157,,2021-01-16,2022-12-21,,2023-02-21,2021-01-29,2021-02-01,ACTUAL,2023-02-21,2023-03-20,ACTUAL,,,,2023-02-21,2023-03-20,ACTUAL,2021-03-23,ACTUAL,2021-03-23,2023-02,2023-02-28,2021-12-14,ACTUAL,2021-12-14,2021-12-14,ACTUAL,2021-12-14,,INTERVENTIONAL,ETAPPH,,The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section,The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section,COMPLETED,,PHASE3,1226.0,ACTUAL,University of Zimbabwe,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,It is not yet known if there will be a plan to make individual patient data (IPD) available.,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,OTHER,,,,,,,2021,1.0
NCT03548584,,2018-05-07,2023-05-31,,2023-09-14,2018-06-05,2018-06-07,ACTUAL,2023-09-14,2023-09-18,ACTUAL,,,,2023-09-14,2023-09-18,ACTUAL,2018-05-16,ACTUAL,2018-05-16,2023-09,2023-09-30,2022-06-01,ACTUAL,2022-06-01,2022-05-23,ACTUAL,2022-05-23,,INTERVENTIONAL,,Randomized Sample consisted of all participants who were randomized into this trial.,"A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type","A Phase 3, 12-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-Arm, Fixed-dose Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type",COMPLETED,,PHASE3,345.0,ACTUAL,"Otsuka Pharmaceutical Development & Commercialization, Inc.",,3.0,,,f,,,,,t,f,,,,,,"Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.",Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/,https://clinical-trials.otsuka.com,YES,Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,INDUSTRY,,,,,,,2022,1.0
NCT04100018,,2019-09-20,2024-05-30,,2024-07-18,2019-09-20,2019-09-23,ACTUAL,2024-07-18,2024-07-22,ACTUAL,,,,2024-07-18,2024-07-22,ACTUAL,2020-02-06,ACTUAL,2020-02-06,2024-07,2024-07-31,2024-06-25,ACTUAL,2024-06-25,2023-06-01,ACTUAL,2023-06-01,,INTERVENTIONAL,CheckMate 7DX,,A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer,"A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer",COMPLETED,,PHASE3,1030.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,INDUSTRY,,,,,,,2024,1.0
NCT04512911,,2020-08-11,,,2023-10-04,2020-08-11,2020-08-14,ACTUAL,,,,,,,2023-10-04,2023-10-06,ACTUAL,2023-01,ESTIMATED,2023-01-31,2023-10,2023-10-31,2023-01-23,ESTIMATED,2023-01-23,2023-01-23,ESTIMATED,2023-01-23,,INTERVENTIONAL,EPI-VT,,Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy,Endocardial-Epicardial Radiofrequency Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Montefiore Medical Center,,2.0,,IRB approval expired 1/23/2023 and eclipsed the 6 month institutional window where study can be reinitiated via progress report. No enrollment has taken place.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,OTHER,,,,,,,2023,0.0
NCT04984278,,2021-07-14,2023-11-09,,2024-02-02,2021-07-29,2021-07-30,ACTUAL,2024-02-02,2024-02-05,ACTUAL,,,,2024-02-02,2024-02-05,ACTUAL,2021-08-16,ACTUAL,2021-08-16,2024-02,2024-02-29,2022-11-11,ACTUAL,2022-11-11,2022-11-11,ACTUAL,2022-11-11,,INTERVENTIONAL,RELEASE MSS5,Baseline characteristics were assessed in the Full Analysis Set.,Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis,"A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients With Multiple Sclerosis",TERMINATED,,PHASE3,56.0,ACTUAL,Jazz Pharmaceuticals,,2.0,,The study was terminated based on a business decision by the Sponsor.,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,INDUSTRY,,,,,,,2022,0.0
NCT03325166,,2017-10-06,2022-05-16,,2022-07-14,2017-10-26,2017-10-30,ACTUAL,2022-07-14,2022-08-10,ACTUAL,,,,2022-07-14,2022-08-10,ACTUAL,2017-11-03,ACTUAL,2017-11-03,2022-07,2022-07-31,2021-03-01,ACTUAL,2021-03-01,2021-03-01,ACTUAL,2021-03-01,,INTERVENTIONAL,,,Pembrolizumab and Magnetic Resonance Imaging With Ferumoxytol in Treating Patients With Non-small Cell Lung Cancer and Brain Metastases,"The Use of Perfusion MRI Using Ferumoxytol and Small Molecular Weight Gadolinium (Gd) Agents to Assess Response to Pembrolizumab in Brain Metastases and Systemic Lesions in NSCLC: A Comparison of Imaging Modalities to Address Brain Metastases, Pseudoprogression, and Systemic Lesion Tumor Flare (Neuro-Check Pilot)",TERMINATED,,PHASE2,2.0,ACTUAL,OHSU Knight Cancer Institute,"Due to very low enrollment and staffing issues, data was not collected for analysis of study outcomes.",1.0,,Low accrual,,,,,t,t,f,,,f,,,,,,,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,OTHER,,,,,,,2021,0.0
NCT03686696,,2018-09-03,,,2023-11-21,2018-09-24,2018-09-27,ACTUAL,,,,,,,2023-11-21,2023-11-27,ACTUAL,2018-12-16,ACTUAL,2018-12-16,2023-11,2023-11-30,2023-08-22,ACTUAL,2023-08-22,2023-05-31,ACTUAL,2023-05-31,,INTERVENTIONAL,MINOCA-BAT,,Randomized Evaluation of Beta Blocker and ACEI/ARB Treatment in MINOCA Patients - MINOCA-BAT,Randomized Evaluation of Beta Blocker and Angiotensin Converting Enzyme Inhibitor (ACEI) /Angiotensin Receptor Blocker (ARB) Treatment in MINOCA Patients.,TERMINATED,,PHASE4,198.0,ACTUAL,Uppsala University,,4.0,,Low inclusion rate.,f,,,,t,f,f,,,f,,,,,,YES,"We will make a limited, de-identified set of data available for researchers outside the primary investigators two years after the publication of the primary results of the study. Before data are shared, a data-sharing agreement should be established documenting what data are being shared and how the data can be used. The agreement serves two purposes. First, it protects the agency providing the data, ensuring that the data will not be misused. Second, it prevents miscommunication on the part of the provider of the data and the agency receiving the data by making certain that any questions about data use are discussed. The following items should be covered in the data-sharing agreement:~* Period of agreement~* Intended use of the data~* Constraints on use of the data~* Data confidentiality~* Data security~* Methods of data-sharing",2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,OTHER,,,,,,,2023,0.0
NCT03182894,,2017-06-07,,,2018-08-24,2017-06-07,2017-06-09,ACTUAL,,,,,,,2018-08-24,2018-08-28,ACTUAL,2018-09-30,ESTIMATED,2018-09-30,2018-08,2018-08-31,2020-07-30,ESTIMATED,2020-07-30,2019-07-30,ESTIMATED,2019-07-30,,INTERVENTIONAL,,,Epacadostat in Combination With Pembrolizumab and Azacitidine in Subjects With Metastatic Colorectal Cancer,A Phase IB/II Study of Epacadostat (INCB024360) in Combination With Pembrolizumab (MK-3475) and Azacitidine in Subjects With Chemo-refractory Metastatic Colorectal Cancer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Pittsburgh,,1.0,,Study will not be conducted due to changes related to the investigational agent.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,OTHER,,,,,,,2020,0.0
NCT02438852,,2015-05-06,,,2019-04-13,2015-05-07,2015-05-08,ESTIMATED,,,,,,,2019-04-13,2019-04-16,ACTUAL,2019-02-25,ESTIMATED,2019-02-25,2019-04,2019-04-30,2022-02-25,ESTIMATED,2022-02-25,2021-02-25,ESTIMATED,2021-02-25,,INTERVENTIONAL,,,Continuous Infusion of Ropivacaine Hydrochloride in Reducing Pain After Surgery in Patients With Bladder Cancer,"Efficacy of Continuous Infusion of Local Anesthesia After Radical Cystectomy: A Randomized, Double Blind, Placebo Controlled Study",WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Southern California,,2.0,,No funding,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,OTHER,,,,,,,2022,0.0
NCT04586244,,2020-10-08,,,2024-02-09,2020-10-08,2020-10-14,ACTUAL,,,,,,,2024-02-09,2024-02-13,ACTUAL,2022-01-14,ACTUAL,2022-01-14,2024-02,2024-02-29,2024-01-29,ACTUAL,2024-01-29,2024-01-29,ACTUAL,2024-01-29,,INTERVENTIONAL,Optimus,,An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma,"An Open-Label, Randomized, Phase 2, Umbrella Study to Investigate the Biological Rational of Various Neoadjuvant Therapies for Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Cisplatin-Ineligible or Refuse Cisplatin Therapy and Undergoing Radical Cystectomy",TERMINATED,,PHASE2,30.0,ACTUAL,Incyte Corporation,,5.0,,Business Decision. No safety concerns contributed to this decision.,f,,,,t,t,f,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,INDUSTRY,,,,,,,2024,0.0
NCT04358068,,2020-04-20,2021-02-24,,2021-11-12,2020-04-20,2020-04-22,ACTUAL,2021-03-24,2021-04-01,ACTUAL,,,,2021-11-12,2021-11-16,ACTUAL,2020-05-13,ACTUAL,2020-05-13,2021-10,2021-10-31,2020-07-08,ACTUAL,2020-07-08,2020-07-08,ACTUAL,2020-07-08,,INTERVENTIONAL,,Participants who initiated study treatment,Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19,"A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19",TERMINATED,,PHASE2,20.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),The study was terminated early due to slow enrollment and lack of community enthusiasm. Follow-up through week 24 was not completed for any participant. Participants were asked to complete the Day 20 visit and then were discontinued from the study.,2.0,,Slow enrollment and lack of community enthusiasm,f,,,,t,t,f,,,,,,Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.,* With whom?~  * Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses?~  * To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism will data be made available?~  * Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at: https://submit.mis.s-3.net/ Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.,,YES,"Individual participant data that underlie results in the publication, after deidentification.",2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,NIH,,,,,,,2020,0.0
NCT01280669,,2011-01-20,,,2023-10-24,2011-01-20,2011-01-21,ESTIMATED,,,,,,,2023-10-24,2023-10-26,ACTUAL,2022-09,ESTIMATED,2022-09-30,2023-10,2023-10-31,2024-12,ESTIMATED,2024-12-31,2024-09,ESTIMATED,2024-09-30,,INTERVENTIONAL,SAVE-2,,Intravitreal Sirolimus as Therapeutic Approach to Uveitis,"Sirolimus as a Therapeutic Approach for Uveitis: A Phase 2, Open-label, Randomized Study to Assess the Safety, Tolerability, and Bioactivity of Two Doses of Intravitreal Injection of Sirolimus in Patients With Non-infectious Uveitis",WITHDRAWN,,PHASE2,0.0,ACTUAL,Stanford University,,2.0,,Never started due to sponsor decision,f,,,,f,t,f,,,,,,,,,,,2024-10-14 21:27:39.41508,2024-10-14 21:27:39.41508,OTHER,,,,,,,2024,0.0
NCT06400264,,2024-05-03,,,2024-05-03,2024-05-03,2024-05-06,ACTUAL,,,,,,,2024-05-03,2024-05-06,ACTUAL,2022-02-22,ACTUAL,2022-02-22,2024-04,2024-04-30,2023-01-17,ACTUAL,2023-01-17,2023-01-17,ACTUAL,2023-01-17,,INTERVENTIONAL,,,Testing Nivolumab and BMS-986016 (Relatlimab) as Potentially Targeting Treatment in Cancers That Are LAG-3+ and Have Mismatch Repair Deficiency (MATCH - Subprotocol Z1M),MATCH Treatment Subprotocol Z1M: Phase 2 Study of Nivolumab and BMS-986016 (Relatlimab) in Patients With LAG-3+ Tumors With Mismatch Repair Deficiency (MMR-d) After Progression on Anti-PD-1/PD-L1 Therapy,WITHDRAWN,,PHASE2,0.0,ACTUAL,National Cancer Institute (NCI),,1.0,,"No result will be reported- no patient accrued. Status Withdrawn: Study halted prematurely, prior to enrollment of first participant.",,,,,,t,f,,,f,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.",2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,NIH,,,,,,,2023,0.0
NCT01904136,,2013-07-17,2023-03-02,,2024-01-22,2013-07-17,2013-07-22,ESTIMATED,2023-12-20,2024-01-17,ACTUAL,,,,2024-01-22,2024-01-24,ACTUAL,2014-04-22,ACTUAL,2014-04-22,2024-01,2024-01-31,2022-02-28,ACTUAL,2022-02-28,2022-02-28,ACTUAL,2022-02-28,,INTERVENTIONAL,,Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.,"Natural Killer Cells Before and After Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia",A Phase I/II Clinical Trial of NK Cells Administration to Prevent Disease Relapse for Patient With High-Risk Myeloid Malignancies Undergoing Haploidentical Stem-Cell Transplantation,COMPLETED,,PHASE1/PHASE2,54.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 22:30:35.83594,2024-10-15 22:30:35.83594,OTHER,,,,,,,2022,1.0
NCT03944902,,2019-05-01,,,2023-11-17,2019-05-07,2019-05-10,ACTUAL,,,,,,,2023-11-17,2023-11-21,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2023-11,2023-11-30,2022-01-05,ACTUAL,2022-01-05,2022-01-05,ACTUAL,2022-01-05,,INTERVENTIONAL,BRCA,,CB-839 in Combination With Niraparib in Platinum Resistant BRCA -Wild-type Ovarian Cancer Patients,Phase 1 Trial of CB-839 in Combination With Niraparib in Platinum Resistant BRCA-wild-type Ovarian Cancer Patients,TERMINATED,,PHASE1,1.0,ACTUAL,University of Alabama at Birmingham,,3.0,,will not resume. company choosing not to continue with drug. one participant now off study.,f,,,,t,t,f,,,,,,The above documents will be posted on CT.gov and available as long as study record is posted.,To be determined.,,YES,To be determined.,2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,OTHER,,,,,,,2022,0.0
NCT02965443,,2016-10-28,,,2020-02-07,2016-11-11,2016-11-16,ESTIMATED,,,,,,,2020-02-07,2020-02-11,ACTUAL,2018-02-02,ACTUAL,2018-02-02,2018-05,2018-05-31,2020-02-03,ACTUAL,2020-02-03,2020-02-03,ACTUAL,2020-02-03,,INTERVENTIONAL,DapaSaxaBBIT,,Dapagliflozin + Saxagliptin in a Basal-bolus Insulin Treatment,Effectiveness of Dapagliflozin + Saxagliptin to Revert From a Basal-bolus Insulin Treatment (BBIT) Regimen to a Basal Supported Oral Therapy (BOT) in Patients With Type 2 Diabetes,TERMINATED,,PHASE4,4.0,ACTUAL,University Hospital Tuebingen,,2.0,,Low patient recruitment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,OTHER,,,,,,,2020,0.0
NCT02915744,,2016-09-22,2021-07-06,,2023-04-10,2016-09-23,2016-09-27,ESTIMATED,2021-08-03,2021-08-27,ACTUAL,,,,2023-04-10,2023-04-14,ACTUAL,2016-11,,2016-11-30,2023-04,2023-04-30,2020-07,ACTUAL,2020-07-31,2020-07,ACTUAL,2020-07-31,,INTERVENTIONAL,ATTAIN,,"A Study of Etirinotecan Pegol (NKTR-102) Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine","A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine",COMPLETED,,PHASE3,178.0,ACTUAL,Nektar Therapeutics,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,INDUSTRY,,,,,,,2020,0.0
NCT05491603,,2022-07-28,,,2023-09-05,2022-08-04,2022-08-08,ACTUAL,,,,,,,2023-09-05,2023-09-07,ACTUAL,2023-11,ESTIMATED,2023-11-30,2023-02,2023-02-28,2023-11-30,ESTIMATED,2023-11-30,2023-11-30,ESTIMATED,2023-11-30,,INTERVENTIONAL,,,"A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis","An Observer-Blinded, Randomized, Aqueous Gel-Controlled Trial of the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis",SUSPENDED,,PHASE2,60.0,ESTIMATED,"DermBiont, Inc.",,3.0,,"Suspended: Study halted prematurely but potentially will resume. Sponsor suspension, and not due to safety or site-related matters.",,,,,,t,f,,,,,,,,,,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,INDUSTRY,,,,,,,2023,0.0
NCT01313429,,2011-03-10,,,2020-03-02,2011-03-10,2011-03-11,ESTIMATED,,,,,,,2020-03-02,2020-03-03,ACTUAL,2011-03-04,ACTUAL,2011-03-04,2020-03,2020-03-31,2020-02-26,ACTUAL,2020-02-26,2020-02-26,ACTUAL,2020-02-26,,INTERVENTIONAL,,,"Tumor Cell Vaccine for Patients Undergoing Surgery for Sarcomas, Melanomas, Germ Cell Tumors, or Malignancies That Have Metastasized to the Lungs, Pleura, or Mediastinum","Adjuvant Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib in Patients Undergoing Resection of Sarcomas, Melanomas, Germ Cell Tumors, or Epithelial Malignancies Metastatic to Lungs, Pleura, or Mediastinum",TERMINATED,,PHASE1,19.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,"Per stopping rule if 12 patients underwent immune response analysis after 6 vaccinations and none developed a response, the protocol would stop accrual.",f,,,,,t,f,,,,,,,,,,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,NIH,,,,,,,2020,0.0
NCT02412631,,2015-03-12,2021-04-10,,2021-05-17,2015-04-06,2015-04-09,ESTIMATED,2021-05-17,2021-06-10,ACTUAL,,,,2021-05-17,2021-06-10,ACTUAL,2016-06-15,ACTUAL,2016-06-15,2021-05,2021-05-31,2020-04-17,ACTUAL,2020-04-17,2020-04-17,ACTUAL,2020-04-17,,INTERVENTIONAL,,,Addressing Post Cessation Weight Gain,Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention,TERMINATED,,PHASE2/PHASE3,84.0,ACTUAL,Mayo Clinic,,2.0,,Lorcaserin removed from market,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,OTHER,,,,,,,2020,0.0
NCT04500548,,2020-08-04,,,2022-09-09,2020-08-04,2020-08-05,ACTUAL,,,,,,,2022-09-09,2022-09-10,ACTUAL,2021-01-28,ACTUAL,2021-01-28,2022-08,2022-08-31,2022-06-21,ACTUAL,2022-06-21,2022-06-21,ACTUAL,2022-06-21,,INTERVENTIONAL,,,"Testing the Combination of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) in Children, Adolescent, and Young Adult Patients With Relapsed/Refractory Cancers That Have an Increased Number of Genetic Changes, The 3CI Study","3CI Study: Childhood Cancer Combination Immunotherapy. Phase Ib and Expansion Study of Nivolumab Combination Immunotherapy in Children, Adolescent and Young Adult (CAYA) Patients With Relapsed/Refractory Hypermutant Cancers",WITHDRAWN,,PHASE1,0.0,ACTUAL,National Cancer Institute (NCI),,2.0,,Inadequate accrual rate,f,,,,t,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.",2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,NIH,,,,,,,2022,0.0
NCT04178447,,2019-11-25,,,2020-11-17,2019-11-25,2019-11-26,ACTUAL,,,,,,,2020-11-17,2020-11-18,ACTUAL,2019-12-10,ACTUAL,2019-12-10,2020-03,2020-03-31,2020-07-14,ACTUAL,2020-07-14,2020-07-14,ACTUAL,2020-07-14,,INTERVENTIONAL,,,Pharmacokinetic Profile of Glepaglutide After a Single Injection in Subjects With Varying Degrees of Renal Function,"An Open-label, Multi-center Trial to Evaluate the Pharmacokinetic Profile of Glepaglutide After a Single Subcutaneous Injection in Subjects With Varying Degrees of Renal Function",COMPLETED,,PHASE1,16.0,ACTUAL,Zealand Pharma,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,INDUSTRY,,,,,,,2020,0.0
NCT02891226,,2016-09-01,2022-02-02,2020-03-06,2022-08-01,2016-09-01,2016-09-07,ESTIMATED,2022-02-02,2022-02-28,ACTUAL,2020-03-06,2020-03-11,ACTUAL,2022-08-01,2022-08-30,ACTUAL,2016-12-14,ACTUAL,2016-12-14,2022-08,2022-08-31,2021-02-05,ACTUAL,2021-02-05,2018-12-11,ACTUAL,2018-12-11,,INTERVENTIONAL,SERENITY,All randomized participants.,A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease,"A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY)",COMPLETED,,PHASE2,191.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,,,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,INDUSTRY,,,,,,,2021,1.0
NCT05409235,,2022-06-03,2024-04-29,,2024-07-16,2022-06-03,2022-06-08,ACTUAL,2024-07-16,2024-08-09,ACTUAL,,,,2024-07-16,2024-08-09,ACTUAL,2022-07-29,ACTUAL,2022-07-29,2024-07,2024-07-31,2023-12-29,ACTUAL,2023-12-29,2023-12-29,ACTUAL,2023-12-29,,INTERVENTIONAL,,,Nesvategrast (OTT166) in Diabetic Retinopathy (DR),"OTT166-201 A Phase 2 Randomized, Double-Masked, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of OTT166 Ophthalmic Solution in the Treatment of Diabetic Retinopathy (DR)",COMPLETED,,PHASE2,225.0,ACTUAL,"OcuTerra Therapeutics, Inc.",\[Not specified\],4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 11:38:14.970362,2024-10-15 11:38:14.970362,INDUSTRY,,,,,,,2023,1.0
NCT03935347,,2019-04-30,,,2019-12-27,2019-04-30,2019-05-02,ACTUAL,,,,,,,2019-12-27,2020-01-02,ACTUAL,2019-06-20,ACTUAL,2019-06-20,2019-12,2019-12-31,2023-05-01,ESTIMATED,2023-05-01,2022-05-01,ESTIMATED,2022-05-01,,INTERVENTIONAL,,,Adoptive Cell Therapy With (LN-145) in Combination With Pembrolizumab in Treating Patients With Unresectable or Metastatic Transitional Cell Cancer Who Have Failed Cisplatin-Based Chemotherapy,"Phase 2 Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) With Pembrolizumab, in Subjects Who Have Failed Cisplatin-Based Chemotherapy With Locally Advanced (Unresectable) or Metastatic Transitional Cell Cancer (TCC) of the Urothelium",WITHDRAWN,,PHASE2,0.0,ACTUAL,Roswell Park Cancer Institute,,1.0,,no accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,OTHER,,,,,,,2023,0.0
NCT04272203,,2020-02-14,,,2022-09-06,2020-02-14,2020-02-17,ACTUAL,,,,,,,2022-09-06,2022-09-08,ACTUAL,2020-05-05,ACTUAL,2020-05-05,2022-09,2022-09-30,2022-06-27,ACTUAL,2022-06-27,2022-06-27,ACTUAL,2022-06-27,,INTERVENTIONAL,,,"A Study to Determine Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose (RP2D) of Intravenous ABBV-184 in Adult Participants With Previously Treated Cancers","A Phase 1 First in Human, Multicenter, Open-Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics, and RP2D of ABBV-184 in Subjects With Previously Treated Cancers",TERMINATED,,PHASE1,14.0,ACTUAL,AbbVie,,4.0,,Strategic considerations,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,INDUSTRY,,,,,,,2022,0.0
NCT03519984,,2018-04-26,,,2021-11-17,2018-05-08,2018-05-09,ACTUAL,,,,,,,2021-11-17,2021-11-30,ACTUAL,2018-05-09,ACTUAL,2018-05-09,2021-11,2021-11-30,2020-11-24,ACTUAL,2020-11-24,2020-11-24,ACTUAL,2020-11-24,,INTERVENTIONAL,,,EphB4-HSA Fusion Protein and Cytarabine /or Liposomal Vincristine in Patients With Recurrent or Refractory Acute Leukemia,A Phase I Dose Escalation Study With Expansion to Evaluate the Safety of SEPHB4-HSA in Combination With Cytarabine or Liposomal Vincristine in Patients With Relapsed or Refractory Acute Leukemia,TERMINATED,,PHASE1,3.0,ACTUAL,University of Southern California,,2.0,,Study drug supply issue,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,OTHER,,,,,,,2020,0.0
NCT04451187,,2020-06-26,,,2023-03-30,2020-06-26,2020-06-30,ACTUAL,,,,,,,2023-03-30,2023-03-31,ACTUAL,2020-07-16,ACTUAL,2020-07-16,2023-03,2023-03-31,2023-03-16,ACTUAL,2023-03-16,2023-03-16,ACTUAL,2023-03-16,,INTERVENTIONAL,,,A Study of Oral Seltorexant as an add-on Medication to an Antidepressant on On-road Driving Performance in Participants With Major Depressive Disorder,"A Multicentric, Randomized, Double-Blind, Placebo- and Positive-Controlled 4-way Crossover Study to Evaluate the Effects of Single and Repeated Administration of Oral Seltorexant as an add-on Medication to an Antidepressant on On-Road Driving Performance in Participants With Major Depressive Disorder",COMPLETED,,PHASE1,63.0,ACTUAL,"Janssen Research & Development, LLC",,4.0,,,f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,INDUSTRY,,,,,,,2023,0.0
NCT03130348,,2017-04-21,,,2018-02-28,2017-04-21,2017-04-26,ACTUAL,,,,,,,2018-02-28,2018-03-02,ACTUAL,2018-03-15,ESTIMATED,2018-03-15,2018-02,2018-02-28,2022-04,ESTIMATED,2022-04-30,2022-04,ESTIMATED,2022-04-30,,INTERVENTIONAL,,,Ibrutinib With or Without Bortezomib and Dexamethasone in Treating Patients With Relapsed or Refractory Immunoglobulin Light Chain Amyloidosis,Phase II Study of Ibrutinib With or Without Bortezomib and Dexamethasone for the Treatment of Patients With Relapsed/Refractory Immunoglobulin Light Chain Amyloidosis,WITHDRAWN,,PHASE2,0.0,ACTUAL,Mayo Clinic,,1.0,,Study was dropped at site before participation,f,,,,t,t,f,,,,,,,,,,,2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,OTHER,,,,,,,2022,0.0
NCT01898793,,2013-07-09,2022-12-07,,2023-12-20,2013-07-09,2013-07-12,ESTIMATED,2023-01-04,2023-02-01,ACTUAL,,,,2023-12-20,2024-01-17,ACTUAL,2014-08-11,ACTUAL,2014-08-11,2023-12,2023-12-31,2022-04-04,ACTUAL,2022-04-04,2021-12-28,ACTUAL,2021-12-28,,INTERVENTIONAL,,,Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS),A Phase 1/2 Study of Cytokine-Induced Memory-Like NK Cells in Patients With AML or MDS,TERMINATED,,PHASE1/PHASE2,89.0,ACTUAL,Washington University School of Medicine,,7.0,,Insufficient funding/staff,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:43:27.455712,2024-10-15 11:43:27.455712,OTHER,,,,,,,2022,0.0
NCT03200093,,2017-06-23,,,2021-04-22,2017-06-26,2017-06-27,ACTUAL,,,,,,,2021-04-22,2021-04-26,ACTUAL,2017-06-08,ACTUAL,2017-06-08,2021-04,2021-04-30,2021-04-22,ACTUAL,2021-04-22,2021-04-22,ACTUAL,2021-04-22,,INTERVENTIONAL,,,Oral Vancomycin for Preventing Clostridium Difficile Recurrence,Secondary Prophylaxis With Oral Vancomycin for Clostridium Difficile Recurrence: A Randomized Control Study,TERMINATED,,PHASE4,65.0,ACTUAL,Rochester General Hospital,,2.0,,Low recruitment due to few eligible participants.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,OTHER,,,,,,,2021,0.0
NCT04769869,,2021-02-12,,,2023-03-17,2021-02-24,2021-02-25,ACTUAL,,,,,,,2023-03-17,2023-03-20,ACTUAL,2022-07-08,ACTUAL,2022-07-08,2023-03,2023-03-31,2023-01-24,ACTUAL,2023-01-24,2023-01-24,ACTUAL,2023-01-24,,INTERVENTIONAL,,,A Clinical Trial in Healthy Volunteers and Patients With Mild Asthma to Investigate a New Medicine (AZD4604) for the Treatment of Asthma,"A Single-blind, Randomized, Placebo-controlled 3 Part Study in Healthy Volunteers and Patients With Mild Asthma to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled AZD4604 Following Single and Multiple Ascending Doses and to Investigate the Anti-inflammatory Effect of Inhaled AZD4604",COMPLETED,,PHASE1,110.0,ACTUAL,AstraZeneca,,19.0,,,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please re-refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,INDUSTRY,,,,,,,2023,1.0
NCT05368558,,2022-05-06,,,2024-09-24,2022-05-06,2022-05-10,ACTUAL,,,,,,,2024-09-24,2024-09-26,ACTUAL,2022-08-18,ACTUAL,2022-08-18,2024-09,2024-09-30,2024-09-20,ACTUAL,2024-09-20,2024-09-20,ACTUAL,2024-09-20,,INTERVENTIONAL,,,Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia,"A 6-Week, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Cariprazine in the Acute Exacerbation of Schizophrenia, With an Additional 18-Week Blinded Extension Period",TERMINATED,,PHASE3,34.0,ACTUAL,AbbVie,,2.0,,Business Decision,f,,,,f,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,INDUSTRY,,,,,,,2024,0.0
NCT02554383,,2015-09-08,2023-03-28,,2023-06-13,2015-09-17,2015-09-18,ESTIMATED,2023-05-11,2023-06-08,ACTUAL,,,,2023-06-13,2023-06-29,ACTUAL,2016-02,ACTUAL,2016-02-29,2023-06,2023-06-30,2023-03-09,ACTUAL,2023-03-09,2022-03-31,ACTUAL,2022-03-31,,INTERVENTIONAL,,"515 children underwent randomization; 257 were randomized to the amoxicillin-clavulanate group and 258 to the placebo group. 3 and 2, respectively, were found ineligible after randomization. The remaining 254 and 256 participants, respectively, were the basis for analysis.",Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?,Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?,COMPLETED,,PHASE3,515.0,ACTUAL,University of Pittsburgh,,2.0,,,f,,,,t,,,,,,,,,,,YES,,2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,OTHER,,,,,,,2023,1.0
NCT03931551,,2019-04-17,,,2023-02-21,2019-04-29,2019-04-30,ACTUAL,,,,,,,2023-02-21,2023-02-22,ACTUAL,2019-04-30,ACTUAL,2019-04-30,2022-06,2022-06-30,2022-03-02,ACTUAL,2022-03-02,2022-03-02,ACTUAL,2022-03-02,,INTERVENTIONAL,OPHELIA,,"Olaparib+Trastuzumab in HER2[+],Breast Cancer Susceptibility Gene (BRCA) Mutated Advanced Breast Cancer",Effectiveness of Olaparib Plus Trastuzumab in HER2-positive BRCA-mutated Advanced Breast Cancer Patients (The OPHELIA Study),TERMINATED,,PHASE2,5.0,ACTUAL,MedSIR,,1.0,,Very slow recruitment due to subject profile,f,,,,t,f,f,,,f,,,,,,NO,It is not planned,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,OTHER,,,,,,,2022,0.0
NCT04031885,,2019-07-23,2021-07-29,,2021-07-29,2019-07-23,2019-07-24,ACTUAL,2021-07-29,2021-08-24,ACTUAL,,,,2021-07-29,2021-08-24,ACTUAL,2019-08-14,ACTUAL,2019-08-14,2021-07,2021-07-31,2020-08-11,ACTUAL,2020-08-11,2020-08-11,ACTUAL,2020-08-11,,INTERVENTIONAL,,All randomized participants.,"A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer","A Multicenter, Open-Label, Randomized-Controlled Study of Abemaciclib, a CDK4 and 6 Inhibitor, in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer With Visceral Metastases",TERMINATED,,PHASE4,4.0,ACTUAL,Eli Lilly and Company,This study was terminated early as a business decision based on the inability to enroll subjects into the trial.,2.0,,Business decision based on the inability to enroll subjects into the trial,t,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 11:43:27.455712,2024-10-15 11:43:27.455712,INDUSTRY,,NCT03763604,AVAILABLE,,,,2020,0.0
NCT04129398,,2019-10-15,2023-09-25,,2024-07-29,2019-10-15,2019-10-16,ACTUAL,2023-09-25,2024-04-01,ACTUAL,,,,2024-07-29,2024-08-21,ACTUAL,2019-12-27,ACTUAL,2019-12-27,2024-07,2024-07-31,2022-10-06,ACTUAL,2022-10-06,2022-10-06,ACTUAL,2022-10-06,,INTERVENTIONAL,,,MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042),"A Phase 3, Open-Label, Single-Arm Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of MK-8228 (Letermovir) for the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients",COMPLETED,,PHASE3,22.0,ACTUAL,Merck Sharp & Dohme LLC,,1.0,,,f,,,,f,f,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,INDUSTRY,,,,,,,2022,1.0
NCT04709575,,2020-12-23,2022-08-22,,2022-09-30,2021-01-12,2021-01-14,ACTUAL,2022-09-30,2022-10-27,ACTUAL,,,,2022-09-30,2022-10-27,ACTUAL,2021-01-14,ACTUAL,2021-01-14,2022-09,2022-09-30,2021-08-24,ACTUAL,2021-08-24,2021-08-24,ACTUAL,2021-08-24,,INTERVENTIONAL,,,Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis,"A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Anti-Bet v 1 Monoclonal Antibodies to Reduce Symptoms of Seasonal Allergic Rhinitis",COMPLETED,,PHASE3,353.0,ACTUAL,Regeneron Pharmaceuticals,,2.0,,,f,,,,t,t,f,,,,,,"Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.","Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency \[EMA\], Pharmaceuticals and Medical Devices Agency \[PMDA\], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).",https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-15 11:43:27.455712,2024-10-15 11:43:27.455712,INDUSTRY,,,,,,,2021,1.0
NCT04744103,,2021-01-31,,,2024-08-19,2021-02-04,2021-02-08,ACTUAL,,,,,,,2024-08-19,2024-08-21,ACTUAL,2023-09-15,ACTUAL,2023-09-15,2024-08,2024-08-31,2023-09-15,ACTUAL,2023-09-15,2023-09-15,ACTUAL,2023-09-15,,INTERVENTIONAL,,,Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis,Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis,WITHDRAWN,,PHASE4,0.0,ACTUAL,Nova Scotia Health Authority,,1.0,,This study has been on hold due to the COVID-19 pandemic. Recruitment never began and the team didn't renew the study,f,,,,f,t,f,,,t,,,,,,NO,Participant data will not be used outside the confines of this study.,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,OTHER,,,,,,,2023,0.0
NCT03890341,,2019-03-25,,,2021-03-25,2019-03-25,2019-03-26,ACTUAL,,,,,,,2021-03-25,2021-03-26,ACTUAL,2021-06-01,ESTIMATED,2021-06-01,2021-03,2021-03-31,2021-11-01,ESTIMATED,2021-11-01,2021-08-01,ESTIMATED,2021-08-01,,INTERVENTIONAL,,,"Study in Women on the Effect of JNJ-64530440 on Oral Contraceptive and Midazolam, and the Effect of a High-fat Meal on JNJ-64530440","A Study in Healthy Female Participants to Investigate the Effect of JNJ-64530440 on the Single-dose of Ethinylestradiol and Drospirenone (Oral Contraceptive), and Midazolam, and the Effect of a High-fat Meal on the Single-dose of JNJ-64530440",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Janssen Research & Development, LLC",,1.0,,Stopped due to a strategic decision.,,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,INDUSTRY,,,,,,,2021,0.0
NCT04938427,,2021-06-18,2024-07-25,,2024-07-25,2021-06-23,2021-06-24,ACTUAL,2024-07-25,2024-08-21,ACTUAL,,,,2024-07-25,2024-08-21,ACTUAL,2021-11-08,ACTUAL,2021-11-08,2024-07,2024-07-31,2024-01-25,ACTUAL,2024-01-25,2024-01-25,ACTUAL,2024-01-25,,INTERVENTIONAL,,Safety Analysis Set included all participants who took at least 1 dose of study drug.,"A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS)",COMPLETED,,PHASE3,270.0,ACTUAL,Takeda,,2.0,,,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,INDUSTRY,,,,,,,2024,1.0
NCT03399838,,2018-01-08,,,2022-09-27,2018-01-12,2018-01-16,ACTUAL,,,,,,,2022-09-27,2022-09-30,ACTUAL,2023-08,ESTIMATED,2023-08-31,2022-09,2022-09-30,2024-08-31,ESTIMATED,2024-08-31,2024-07-31,ESTIMATED,2024-07-31,,INTERVENTIONAL,PedINDEX,,Comparing in Dexmedetomidine With po/pr Midazolam for Procedural Sedation in the Pediatric Emergency Department,The PedINDex Study: Comparing Intranasal Dexmedetomidine With Oral or Rectal Midazolam for Procedural Sedation in the Pediatric Emergency Department.,WITHDRAWN,,PHASE4,0.0,ACTUAL,"Insel Gruppe AG, University Hospital Bern",,2.0,,Sponsor left the hospital,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,OTHER,,,,,,,2024,0.0
NCT05028946,,2021-08-24,,,2022-10-18,2021-08-30,2021-08-31,ACTUAL,,,,,,,2022-10-18,2022-10-20,ACTUAL,2022-05-01,ESTIMATED,2022-05-01,2022-10,2022-10-31,2023-11-07,ESTIMATED,2023-11-07,2023-07-07,ESTIMATED,2023-07-07,,INTERVENTIONAL,,,A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's Disease,"A Phase IB Multiple Ascending Dose Study of Safety and Tolerability of Orally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, in Subjects With Moderate to Severely Active Crohn's Disease",WITHDRAWN,,PHASE1,0.0,ACTUAL,Tiziana Life Sciences LTD,,4.0,,For business reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,INDUSTRY,,,,,,,2023,0.0
NCT05077423,,2021-09-30,,,2023-05-25,2021-09-30,2021-10-14,ACTUAL,,,,,,,2023-05-25,2023-05-30,ACTUAL,2022-05-25,ACTUAL,2022-05-25,2022-11,2022-11-30,2022-12-01,ACTUAL,2022-12-01,2022-12-01,ACTUAL,2022-12-01,,INTERVENTIONAL,,,A Phase 1 Trial of CD33xCD3 BsAb in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia,"A Phase 1, Open-label, Dose-escalation Trial of CD33xCD3 Bispecific Antibody in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia",TERMINATED,,PHASE1,3.0,ACTUAL,Y-mAbs Therapeutics,,1.0,,Study terminated due to business priorities,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,INDUSTRY,,,,,,,2022,0.0
NCT02555657,,2015-09-18,2020-03-27,,2021-11-09,2015-09-18,2015-09-21,ESTIMATED,2020-04-22,2020-05-04,ACTUAL,,,,2021-11-09,2021-12-10,ACTUAL,2015-10-13,ACTUAL,2015-10-13,2021-11,2021-11-30,2020-11-10,ACTUAL,2020-11-10,2019-04-11,ACTUAL,2019-04-11,,INTERVENTIONAL,,,Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119),A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab Versus Single Agent Chemotherapy Per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC) - (KEYNOTE-119),COMPLETED,,PHASE3,622.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,INDUSTRY,,,,,,,2020,1.0
NCT03746002,,2018-11-15,2021-08-24,,2021-09-25,2018-11-15,2018-11-19,ACTUAL,2021-09-25,2021-10-22,ACTUAL,,,,2021-09-25,2021-10-22,ACTUAL,2019-01-01,ACTUAL,2019-01-01,2021-09,2021-09-30,2020-01-10,ACTUAL,2020-01-10,2020-01-10,ACTUAL,2020-01-10,,INTERVENTIONAL,,,Diuretic Effect of Metolazone Pre-dosing Versus Concurrent Dosing,Diuretic Effect of Metolazone Pre-dosing Versus Concurrent Dosing With Furosemide: a Pilot Study,TERMINATED,,PHASE4,3.0,ACTUAL,"University of Maryland, Baltimore","This study was terminated early due to slow enrollment, resulting in an inadequate sample size.",2.0,,Insufficient rate of patient enrollment/accrual.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,OTHER,,,,,,,2020,0.0
NCT03110562,,2017-04-07,2021-06-15,,2024-07-25,2017-04-07,2017-04-12,ACTUAL,2021-06-15,2021-07-08,ACTUAL,,,,2024-07-25,2024-08-21,ACTUAL,2017-05-24,ACTUAL,2017-05-24,2024-07,2024-07-31,2022-05-12,ACTUAL,2022-05-12,2020-02-18,ACTUAL,2020-02-18,,INTERVENTIONAL,BOSTON,"Intent-to-treat (ITT) population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment.","Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma","A Phase 3 Randomized, Controlled, Open-label Study of Selinexor, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)",COMPLETED,,PHASE3,402.0,ACTUAL,Karyopharm Therapeutics Inc,,4.0,,,,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,INDUSTRY,,,,,,,2022,1.0
NCT04001998,,2019-06-26,,,2020-10-29,2019-06-26,2019-06-28,ACTUAL,,,,,,,2020-10-29,2020-10-30,ACTUAL,2021-02,ESTIMATED,2021-02-28,2020-09,2020-09-30,2021-07,ESTIMATED,2021-07-31,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,Healthy Volunteer Study Comparing Tablet and Capsule Formulations,"A Two-Part, Open Label, Complete Crossover Study to Compare the Tablet and Capsule Formulations of BLD-2660, Including a Food Effect Assessment of the Tablet Formulation, and to Assess Dose Proportionality Following Single Oral Doses of BLD-2660 in Tablet Formulation",WITHDRAWN,,PHASE1,0.0,ACTUAL,Blade Therapeutics,,2.0,,On hold to determine chosen formulations,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,INDUSTRY,,,,,,,2021,0.0
NCT04885634,,2021-05-10,,,2023-11-01,2021-05-10,2021-05-13,ACTUAL,,,,,,,2023-11-01,2023-11-03,ACTUAL,2022-10,ESTIMATED,2022-10-31,2023-11,2023-11-30,2024-11,ESTIMATED,2024-11-30,2024-01,ESTIMATED,2024-01-31,,INTERVENTIONAL,SOCRATES-AF,,Semaglutide for the Reduction of Arrhythmia Burden in Overweight AF Patients,Semaglutide for the Reduction of Arrhythmia Burden in Overweight and Obese Patients With Atrial Fibrillation (Pilot Study),WITHDRAWN,,PHASE3,0.0,ACTUAL,Odense University Hospital,,2.0,,Not received funding.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,OTHER,,,,,,,2024,0.0
NCT04491084,,2020-07-21,2023-06-23,,2024-02-22,2020-07-28,2020-07-29,ACTUAL,2023-06-23,2023-07-17,ACTUAL,,,,2024-02-22,2024-02-28,ACTUAL,2021-01-01,ACTUAL,2021-01-01,2024-02,2024-02-29,2022-08-18,ACTUAL,2022-08-18,2022-08-18,ACTUAL,2022-08-18,,INTERVENTIONAL,FLT3,,"FLT3 Ligand, CD40 Agonist Antibody, and Stereotactic Radiotherapy","FLT3 Ligand (CDX-301), CD40 Agonist Antibody (CDX-1140), and Stereotactic Radiotherapy Versus Standard Therapy for Advanced Non-small Cell Lung Cancer: A Phase I/II Randomized Trial",TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,Albert Einstein College of Medicine,,2.0,,Low accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,OTHER,,,,,,,2022,0.0
NCT04380142,,2020-05-06,2022-08-16,,2022-10-27,2020-05-06,2020-05-08,ACTUAL,2022-10-27,2022-11-18,ACTUAL,,,,2022-10-27,2022-11-18,ACTUAL,2020-10-19,ACTUAL,2020-10-19,2022-10,2022-10-31,2021-09-29,ACTUAL,2021-09-29,2021-09-29,ACTUAL,2021-09-29,,INTERVENTIONAL,,Safety Analysis Set: All participants who received any dose of study drug during the Double-Blind Treatment Period.,Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease,"A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients",COMPLETED,,PHASE3,174.0,ACTUAL,AbbVie,,2.0,,,f,,,,f,t,f,,,t,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,INDUSTRY,,,,,,,2021,1.0
NCT03866980,,2019-03-06,,,2024-04-02,2019-03-06,2019-03-07,ACTUAL,,,,,,,2024-04-02,2024-04-03,ACTUAL,2018-11-27,ACTUAL,2018-11-27,2024-04,2024-04-30,2023-12-31,ACTUAL,2023-12-31,2023-06-30,ACTUAL,2023-06-30,,INTERVENTIONAL,,,A Study of Anti-PD-1 AK105 in Patients With Metastatic Nonsquamous Non-small Cell Lung Cancer,"A Phase III, Randomized, Double-blinded, Multicenter Study of AK105 Combined With Carboplatin and Pemetrexed vs Placebo Combined With Carboplatin and Pemetrexed as First-line Therapy in Patients With Metastatic Nonsquamous Non-small Cell Lung Cancer",TERMINATED,,PHASE3,164.0,ACTUAL,Akeso,,3.0,,corporate strategy adjustment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,INDUSTRY,,,,,,,2023,0.0
NCT03641547,,2018-07-10,2023-04-13,,2024-02-02,2018-08-17,2018-08-22,ACTUAL,2024-02-02,2024-07-18,ACTUAL,,,,2024-02-02,2024-07-18,ACTUAL,2018-12-04,ACTUAL,2018-12-04,2022-04,2022-04-30,2022-04-04,ACTUAL,2022-04-04,2022-04-04,ACTUAL,2022-04-04,,INTERVENTIONAL,CHARIOT,,M6620 Plus Standard Treatment in Oesophageal and Other Cancer,A Phase 1 Dose Escalation Safety Study Combining the ATR Inhibitor M6620 With Chemoradiotherapy in Oesophageal Cancer & Other Solid Cancers Using Time to Event Continual Reassessment Method,COMPLETED,,PHASE1,36.0,ACTUAL,University of Oxford,,1.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,OTHER,,,,,,,2022,1.0
NCT04509999,,2020-08-07,,,2021-06-30,2020-08-11,2020-08-12,ACTUAL,,,,,,,2021-06-30,2021-07-01,ACTUAL,2020-10-26,ACTUAL,2020-10-26,2021-06,2021-06-30,2021-06-30,ACTUAL,2021-06-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,,,Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection,Randomized Trial of Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection,WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Florida,,2.0,,No patients enrolled and funding withdrawn,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,OTHER,,,,,,,2021,0.0
NCT04150341,,2019-10-15,2022-02-17,,2022-02-17,2019-11-01,2019-11-04,ACTUAL,2022-02-17,2022-03-18,ACTUAL,,,,2022-02-17,2022-03-18,ACTUAL,2019-11-06,ACTUAL,2019-11-06,2022-02,2022-02-28,2020-09-03,ACTUAL,2020-09-03,2020-08-28,ACTUAL,2020-08-28,,INTERVENTIONAL,,,Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response,"A Randomized, Double-blind, Placebo-controlled, 3-period Crossover Study to Evaluate the Effects of Repeated Doses of Inhaled TD-8236 and Impact on Airway Responses Following Allergen Challenge in Patients With Asthma",COMPLETED,,PHASE2,24.0,ACTUAL,Theravance Biopharma,,3.0,,,f,,,,f,t,f,,,t,,,,,,NO,"Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.",2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,INDUSTRY,,,,,,,2020,1.0
NCT04354259,,2020-04-16,,,2023-12-12,2020-04-20,2020-04-21,ACTUAL,,,,,,,2023-12-12,2023-12-13,ACTUAL,2020-05-13,ACTUAL,2020-05-13,2023-12,2023-12-31,2022-12-08,ACTUAL,2022-12-08,2022-08-19,ACTUAL,2022-08-19,,INTERVENTIONAL,ILIAD,,Interferon Lambda for Immediate Antiviral Therapy at Diagnosis in COVID-19,"Interferon Lambda for Immediate Antiviral Therapy at Diagnosis (ILIAD): A Phase II Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Effect of Peginterferon Lambda for the Treatment of COVID-19",COMPLETED,,PHASE2,157.0,ACTUAL,"University Health Network, Toronto",,4.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 11:43:27.455712,2024-10-15 11:43:27.455712,OTHER,,,,,,,2022,1.0
NCT04684914,,2020-12-22,,,2024-05-28,2020-12-22,2020-12-28,ACTUAL,,,,,,,2024-05-28,2024-05-29,ACTUAL,2020-12-26,ACTUAL,2020-12-26,2024-05,2024-05-31,2024-04-17,ACTUAL,2024-04-17,2024-03-27,ACTUAL,2024-03-27,,INTERVENTIONAL,,,HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB),"Phase 2, Double-blind, Randomized, Placebo-controlled Study of HepTcell (Adjuvanted FP-02.2) as an Immunotherapeutic Vaccine in Treatment-naïve Patients With Inactive Chronic Hepatitis B (CHB)",TERMINATED,,PHASE2,87.0,ACTUAL,"Altimmune, Inc.",,2.0,,Did not meet endpoints,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,INDUSTRY,,,,,,,2024,0.0
NCT04691375,,2020-12-08,,,2024-03-20,2020-12-30,2020-12-31,ACTUAL,,,,,,,2024-03-20,2024-03-22,ACTUAL,2020-10-29,ACTUAL,2020-10-29,2024-03,2024-03-31,2023-09-22,ACTUAL,2023-09-22,2023-08-31,ACTUAL,2023-08-31,,INTERVENTIONAL,,,A Study of PY314 in Subjects With Advanced Solid Tumors,"A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination With Pembrolizumab in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,86.0,ACTUAL,Ikena Oncology,,14.0,,Sponsor business decision.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,INDUSTRY,,,,,,,2023,0.0
NCT04656418,,2020-12-01,2023-06-07,,2023-06-07,2020-12-01,2020-12-07,ACTUAL,2023-06-07,2023-06-29,ACTUAL,,,,2023-06-07,2023-06-29,ACTUAL,2021-01-27,ACTUAL,2021-01-27,2023-06,2023-06-30,2022-06-07,ACTUAL,2022-06-07,2022-06-07,ACTUAL,2022-06-07,,INTERVENTIONAL,,ITT analysis set included all the randomized participants who provided written informed consent and underwent study screening procedures.,CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks,"A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema",COMPLETED,,PHASE3,64.0,ACTUAL,CSL Behring,,2.0,,,f,,,,t,t,f,,,,,,IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.,Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.~An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.~The requesting party must execute an appropriate data sharing agreement before IPD will be made available.,,YES,"CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.~Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.~If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.",2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,INDUSTRY,,,,,,,2022,1.0
NCT04880850,,2021-05-06,,2023-06-15,2024-05-27,2021-05-06,2021-05-11,ACTUAL,,,,,2023-06-18,ACTUAL,2024-05-27,2024-05-29,ACTUAL,2021-05-14,ACTUAL,2021-05-14,2024-05,2024-05-31,2022-06-16,ACTUAL,2022-06-16,2022-06-16,ACTUAL,2022-06-16,,INTERVENTIONAL,ONWARDS 4,,"A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4)","A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Bolus Insulin With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes on a Basal-bolus Regimen",COMPLETED,,PHASE3,582.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,INDUSTRY,,,,,,,2022,1.0
NCT05511519,,2022-07-29,,,2024-04-29,2022-08-19,2022-08-23,ACTUAL,,,,,,,2024-04-29,2024-04-30,ACTUAL,2022-07-12,ACTUAL,2022-07-12,2024-04,2024-04-30,2024-01-03,ACTUAL,2024-01-03,2023-12-06,ACTUAL,2023-12-06,,INTERVENTIONAL,,,Study of ATI-450 vs Placebo in Patients With Moderate to Severe Psoriatic Arthritis,"A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zunsemetinib vs Placebo in Patients With Moderate-to-Severe Active Psoriatic Arthritis",TERMINATED,,PHASE2,47.0,ACTUAL,"Aclaris Therapeutics, Inc.",,2.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,,,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,INDUSTRY,,,,,,,2024,0.0
NCT05131477,,2021-11-11,,2024-04-24,2024-04-25,2021-11-11,2021-11-23,ACTUAL,,,,,2024-04-18,ACTUAL,2024-04-25,2024-04-30,ACTUAL,2021-12-13,ACTUAL,2021-12-13,2024-04,2024-04-30,2024-02-21,ACTUAL,2024-02-21,2023-04-26,ACTUAL,2023-04-26,,INTERVENTIONAL,STREAM-AD,,"Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study","A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate-to-Severe Atopic Dermatitis",COMPLETED,,PHASE2,390.0,ACTUAL,Kymab Limited,,5.0,,,f,,,,t,t,f,,,,,,,,https://vivli.org,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.~Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,INDUSTRY,,,,,,,2024,1.0
NCT04756206,,2021-02-05,,,2021-02-11,2021-02-11,2021-02-16,ACTUAL,,,,,,,2021-02-11,2021-02-16,ACTUAL,2019-01-01,ACTUAL,2019-01-01,2021-02,2021-02-28,2020-09-01,ACTUAL,2020-09-01,2020-01-01,ACTUAL,2020-01-01,,INTERVENTIONAL,,,Role of Dutasteride in Treatment of Chronic Prostatitis,Role of Dutasteride in Treatment of Category IIIB Chronic Prostatitis (A Placebo-Controlled Study),COMPLETED,,PHASE2/PHASE3,50.0,ACTUAL,Ain Shams University,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,OTHER,,,,,,,2020,1.0
NCT04528758,,2020-08-13,,,2022-08-23,2020-08-24,2020-08-27,ACTUAL,,,,,,,2022-08-23,2022-08-24,ACTUAL,2018-10-16,ACTUAL,2018-10-16,2022-08,2022-08-31,2024-12,ESTIMATED,2024-12-31,2024-06,ESTIMATED,2024-06-30,,INTERVENTIONAL,,,F-18 Rhodamine 6G PET Imaging for Myocardial Blood Flow,Preliminary Evaluation of F-18 Rhodamine 6G in Healthy Individuals and Patients With Stable Heart Condition,SUSPENDED,,EARLY_PHASE1,15.0,ESTIMATED,Washington University School of Medicine,,2.0,,re-evaluation of radiotracer,,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 11:43:27.455712,2024-10-15 11:43:27.455712,OTHER,,,,,,,2024,0.0
NCT05317013,,2022-03-21,,,2022-09-22,2022-03-30,2022-04-07,ACTUAL,,,,,,,2022-09-22,2022-09-23,ACTUAL,2022-05-01,ACTUAL,2022-05-01,2022-09,2022-09-30,2022-09-22,ACTUAL,2022-09-22,2022-09-22,ACTUAL,2022-09-22,,INTERVENTIONAL,,,CBD in Postmenopausal Women With Osteopenia,"A Randomized, Double-Blind, Placebo-Controlled, Repeated-Dose Study to Assess the Safety, Tolerability, and Preliminary Effects of CHI-554 in Postmenopausal Women With Osteopenia",TERMINATED,,PHASE1,2.0,ACTUAL,Canopy Growth Corporation,,3.0,,Low enrollment,f,,,,,t,f,,,,,,,,,,,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,INDUSTRY,,,,,,,2022,0.0
NCT02487082,,2015-06-29,2022-07-25,,2024-05-10,2015-06-30,2015-07-01,ESTIMATED,2024-05-10,2024-06-06,ACTUAL,,,,2024-05-10,2024-06-06,ACTUAL,2015-06,,2015-06-30,2024-05,2024-05-31,2021-01-29,ACTUAL,2021-01-29,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Pilot Study of Sleep Therapy and Biomarkers in Children With Autism Spectrum Disorders,Pilot Study of Sleep Therapy and Biomarkers in Children With Autism Spectrum Disorders,TERMINATED,,PHASE2,12.0,ACTUAL,Stony Brook University,"No statistical comparisons were undertaken due to the small sample size in the two groups. Study enrollment/completion proved insufficient to permit any conclusions to be drawn. Enrollment/completion was likely limited because of the study requirement that all prior sleep medications, including melatonin, be discontinued as a condition for study participation.",2.0,,too few subjects enrolled,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,OTHER,,,,,,,2021,0.0
NCT02592707,,2015-10-15,2023-02-22,,2023-07-18,2015-10-29,2015-10-30,ESTIMATED,2023-07-18,2023-07-19,ACTUAL,,,,2023-07-18,2023-07-19,ACTUAL,2017-03-06,ACTUAL,2017-03-06,2023-07,2023-07-31,2022-02-22,ACTUAL,2022-02-22,2022-02-22,ACTUAL,2022-02-22,,INTERVENTIONAL,,The safety analysis set (SAS) included all participants who received 177Lu-IPN01072.,Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs,"An International, Multicenter, Open-label Study to Evaluate Safety, Tolerability, Biodistribution, Dosimetry and Preliminary Efficacy of 177Lu-OPS201 for the Therapy of Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)",TERMINATED,,PHASE1/PHASE2,40.0,ACTUAL,Ipsen,"Due to strategic reasons, the Ipsen management team decided to early terminate the D-FR-01072-001 / OPS-C-001 study. This decision was not due to any safety or tolerability concern, or any event associated with the use of the study drug.",1.0,,Terminated (Due to small number of ongoing patients. Patients ongoing at time of termination could choose to join study D-FR-01072-004 for long term follow-up.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,INDUSTRY,,,,,,,2022,0.0
NCT02850536,,2016-07-14,,,2021-10-20,2016-07-29,2016-08-01,ESTIMATED,,,,,,,2021-10-20,2021-10-21,ACTUAL,2017-02-01,ACTUAL,2017-02-01,2021-10,2021-10-31,2021-09-17,ACTUAL,2021-09-17,2018-12-31,ACTUAL,2018-12-31,,INTERVENTIONAL,HITM-SURE,,CAR-T Hepatic Artery Infusions or Pancreatic Venous Infusions for CEA-Expressing Liver Metastases or Pancreas Cancer,Phase Ib Trial of CAR-T Hepatic Artery Infusions or Pancreatic Venous Infusions Delivered With the Surefire Infusion System (SIS) for CEA-Expressing Liver Metastases or Pancreas Cancer,COMPLETED,,PHASE1,5.0,ACTUAL,Roger Williams Medical Center,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 11:43:27.455712,2024-10-15 11:43:27.455712,OTHER,,,,,,,2021,1.0
NCT04038489,,2019-07-10,,,2021-11-12,2019-07-29,2019-07-30,ACTUAL,,,,,,,2021-11-12,2021-11-22,ACTUAL,2019-10-18,ACTUAL,2019-10-18,2021-11,2021-11-30,2023-04-30,ESTIMATED,2023-04-30,2023-04-30,ESTIMATED,2023-04-30,,INTERVENTIONAL,Breast 51,,"COX Inhibition and Biomarkers During Neoadjuvant Chemoendocrine Therapy for ER+, HER2- Stage I-III Breast Cancer","COX Inhibition and Biomarkers of Response During Neoadjuvant Chemoendocrine Therapy for Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Stage I-III Breast Cancer",WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Virginia,,1.0,,Lack of accrual,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 11:43:27.455712,2024-10-15 11:43:27.455712,OTHER,,,,,,,2023,0.0
NCT04461886,,2020-07-03,,,2022-05-17,2020-07-07,2020-07-08,ACTUAL,,,,,,,2022-05-17,2022-05-24,ACTUAL,2020-07-08,ACTUAL,2020-07-08,2022-05,2022-05-31,2021-12-07,ACTUAL,2021-12-07,2021-12-07,ACTUAL,2021-12-07,,INTERVENTIONAL,,,A Long-term Study of NPC-12G Gel in Neurofibromatosis Type I,A Long-term Study of NPC-12G Gel in Neurofibromatosis Type I,TERMINATED,,PHASE3,100.0,ACTUAL,Nobelpharma,,1.0,,Sponsor decision,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,INDUSTRY,,,,,,,2021,0.0
NCT04648020,,2020-11-19,,,2023-05-26,2020-11-23,2020-12-01,ACTUAL,,,,,,,2023-05-26,2023-05-31,ACTUAL,2021-02-11,ACTUAL,2021-02-11,2023-05,2023-05-31,2023-05-14,ACTUAL,2023-05-14,2023-05-14,ACTUAL,2023-05-14,,INTERVENTIONAL,VOICE,,Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer.,"A Phase 2b/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Clonidine Mucoadhesive Buccal Tablet to Placebo to Prevent Chemoradiotherapy-induced Severe Oral Mucositis in Patients With Oropharyngeal Cancer",TERMINATED,,PHASE2/PHASE3,190.0,ACTUAL,Monopar Therapeutics,,2.0,,Interim Analysis did not meet the pre-defined threshold for efficacy of a 15% absolute difference in SOM prevention between Validive and placebo.,f,,,,t,t,f,,,,,,,,,,,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,INDUSTRY,,,,,,,2023,0.0
NCT05583188,,2022-10-13,,,2024-07-17,2022-10-13,2022-10-17,ACTUAL,,,,,,,2024-07-17,2024-07-19,ACTUAL,2023-02-01,ACTUAL,2023-02-01,2024-07,2024-07-31,2024-03-18,ACTUAL,2024-03-18,2024-02-08,ACTUAL,2024-02-08,,INTERVENTIONAL,VIGOR,,Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy in Early-Stage Resectable NSCLC,Neoadjuvant Soft Tissue Ablation Utilizing Aliya™ Pulsed Electric Fields With Systemic Therapy in Early-Stage Resectable Non-Small Cell Lung Cancer (NSCLC),TERMINATED,,PHASE4,5.0,ACTUAL,"Galvanize Therapeutics, Inc.",,1.0,,Strategic,f,,,,t,f,t,,,f,,,,,,NO,No plan of data sharing,2024-10-15 11:43:27.455712,2024-10-15 11:43:27.455712,INDUSTRY,,,,,,,2024,0.0
NCT04627831,,2020-10-27,,,2022-04-01,2020-11-06,2020-11-13,ACTUAL,,,,,,,2022-04-01,2022-04-11,ACTUAL,2022-01,ESTIMATED,2022-01-31,2021-02,2021-02-28,2023-04,ESTIMATED,2023-04-30,2023-03,ESTIMATED,2023-03-31,,INTERVENTIONAL,,,Comparison of Captisol-Enabled™ Iohexol and Omnipaque™ in Patients With Impaired Renal Function Undergoing Coronary Angiography,Randomized Parallel Group Study Comparing the Renal Safety of CAPTISOL-Enabled™ Iohexol (CE-Iohexol) Injection and Omnipaque™ (Iohexol) Injection in Patients With Impaired Renal Function Undergoing Coronary Angiography,WITHDRAWN,,PHASE2,0.0,ACTUAL,Ligand Pharmaceuticals,,2.0,,Internal decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,INDUSTRY,,,,,,,2023,0.0
NCT05091528,,2021-10-12,2022-07-18,,2022-07-22,2021-10-12,2021-10-25,ACTUAL,2022-07-22,2022-08-18,ACTUAL,,,,2022-07-22,2022-08-18,ACTUAL,2022-02-08,ACTUAL,2022-02-08,2022-07,2022-07-31,2022-07-07,ACTUAL,2022-07-07,2022-07-07,ACTUAL,2022-07-07,,INTERVENTIONAL,,All enrolled participants who received at least one dose of SBT6050.,A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers,"An Open-label, Phase 1/2, Dose-escalation and Expansion Study of SBT6050 Combined With Other HER2-directed Therapies in Subjects With Pretreated Unresectable Locally Advanced and/or Metastatic HER2-expressing or HER2-amplified Cancers",TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,Silverback Therapeutics,Early termination leading to small numbers of participants analyzed.,4.0,,Sponsor decision based on strategic re-alignment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:43:27.455712,2024-10-15 11:43:27.455712,INDUSTRY,,,,,,,2022,0.0
NCT04524403,,2020-08-06,2024-05-21,,2024-05-21,2020-08-21,2020-08-24,ACTUAL,2024-05-21,2024-06-13,ACTUAL,,,,2024-05-21,2024-06-13,ACTUAL,2020-09-09,ACTUAL,2020-09-09,2024-05,2024-05-31,2022-08-25,ACTUAL,2022-08-25,2022-07-29,ACTUAL,2022-07-29,,INTERVENTIONAL,,All enrolled patients,"A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia Taking Antipsychotic Medications (GRATITUDE II)",COMPLETED,,PHASE2,150.0,ACTUAL,Corcept Therapeutics,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:43:27.455712,2024-10-15 11:43:27.455712,INDUSTRY,,,,,,,2022,1.0
NCT02420223,,2015-03-03,2020-02-24,,2021-05-12,2015-04-16,2015-04-17,ESTIMATED,2021-05-12,2021-06-07,ACTUAL,,,,2021-05-12,2021-06-07,ACTUAL,2015-07-17,ACTUAL,2015-07-17,2021-05,2021-05-31,2020-02,ACTUAL,2020-02-29,2018-07,ACTUAL,2018-07-31,,INTERVENTIONAL,,,Study of Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in HCT Recipients,Randomized Controlled Pilot Study Using Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in Hematopoietic Stem Cell Transplant (HCT) Recipients,COMPLETED,,PHASE2,25.0,ACTUAL,Medical College of Wisconsin,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 08:36:51.933974,2024-10-16 08:36:51.933974,OTHER,,,,,,,2020,1.0
NCT03685149,,2018-09-21,2023-10-03,,2024-07-25,2018-09-24,2018-09-26,ACTUAL,2024-07-25,2024-08-20,ACTUAL,,,,2024-07-25,2024-08-20,ACTUAL,2019-07-23,ACTUAL,2019-07-23,2024-07,2024-07-31,2022-07-31,ACTUAL,2022-07-31,2022-07-31,ACTUAL,2022-07-31,,INTERVENTIONAL,,,Pilot Randomized Trial With Flecainide in ARVC Patients,Pilot Randomized Trial With Flecainide in ARVC Patients,COMPLETED,,PHASE2,22.0,ACTUAL,University of Rochester,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,This is a small pilot trial with limited dataset which will be mostly explored by enrolling center investigators.,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,OTHER,,,,,,,2022,1.0
NCT06006286,,2023-08-17,,,2024-08-22,2023-08-17,2023-08-23,ACTUAL,,,,,,,2024-08-22,2024-08-26,ACTUAL,2023-08-08,ACTUAL,2023-08-08,2024-08,2024-08-31,2023-11-10,ACTUAL,2023-11-10,2023-11-10,ACTUAL,2023-11-10,,INTERVENTIONAL,,,A Study Evaluating Atezolizumab and Bevacizumab Plus ADI-PEG 20 in Patients With Locally Advanced / Metastatic Hepatocellular Carcinoma,A Pilot Study Evaluating Atezolizumab and Bevacizumab Plus ADI-PEG 20 in Patients With Locally Advanced / Metastatic Hepatocellular Carcinoma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,0 participants registered,,,,,t,t,f,,,,,,,,,,,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,OTHER,,,,,,,2023,0.0
NCT03929835,,2019-04-24,,,2021-07-28,2019-04-26,2019-04-29,ACTUAL,,,,,,,2021-07-28,2021-08-04,ACTUAL,2020-09-01,ESTIMATED,2020-09-01,2021-07,2021-07-31,2022-09-01,ESTIMATED,2022-09-01,2022-09-01,ESTIMATED,2022-09-01,,INTERVENTIONAL,,,Study to Investigate the Efficacy and Safety of Cannabis Oil for the Treatment of Subjects With Hidradenitis Suppurativa,"A Phase Ⅱ, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabis Oil for the Treatment of Subjects With Hidradenitis Suppurativa",WITHDRAWN,,PHASE2,0.0,ACTUAL,TO Pharmaceuticals,,2.0,,withdrawn due to COVID-19,f,,,,f,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 11:43:27.455712,2024-10-15 11:43:27.455712,INDUSTRY,,,,,,,2022,0.0
NCT03801525,,2019-01-09,2024-03-04,,2024-04-10,2019-01-09,2019-01-11,ACTUAL,2024-04-10,2024-04-19,ACTUAL,,,,2024-04-10,2024-04-19,ACTUAL,2019-05-16,ACTUAL,2019-05-16,2024-04,2024-04-30,2022-12-20,ACTUAL,2022-12-20,2022-12-20,ACTUAL,2022-12-20,,INTERVENTIONAL,ULTRA-V,"Safety population consisted of all participants who received at least one dose of any study drug (ublituximab, umbralisib, and venetoclax).",Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V),Phase 2/3 Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects With Chronic Lymphocytic Leukemia (CLL),TERMINATED,,PHASE2/PHASE3,277.0,ACTUAL,"TG Therapeutics, Inc.","Due to sponsor's business decision, the clinical trial was terminated by the sponsor prematurely. As such, the study results are reflective of the data captured to the time of study termination and with limited data verification.",3.0,,Strategic/Business decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,INDUSTRY,,,,,,,2022,0.0
NCT03827018,,2019-01-25,2023-08-02,2021-08-02,2023-10-17,2019-01-31,2019-02-01,ACTUAL,2023-09-21,2023-10-17,ACTUAL,,2023-10-17,ACTUAL,2023-10-17,2023-10-23,ACTUAL,2018-09-20,ACTUAL,2018-09-20,2023-10,2023-10-31,2020-11-25,ACTUAL,2020-11-25,2020-08-13,ACTUAL,2020-08-13,,INTERVENTIONAL,,,KPL-301 for Subjects With Giant Cell Arteritis,"A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis",COMPLETED,,PHASE2,70.0,ACTUAL,"Kiniksa Pharmaceuticals International, plc",,2.0,,,f,,,,t,t,t,,,,,,,,,NO,,2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,INDUSTRY,,,,,,,2020,1.0
NCT03298893,,2017-09-27,,,2024-02-01,2017-09-27,2017-10-02,ACTUAL,,,,,,,2024-02-01,2024-02-02,ACTUAL,2017-11-27,ACTUAL,2017-11-27,2022-04,2022-04-30,2022-03-07,ACTUAL,2022-03-07,2020-10-30,ACTUAL,2020-10-30,,INTERVENTIONAL,NiCOL,,Nivolumab in Association With Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed by Adjuvant Nivolumab for up to 6 Months,A Phase-I Study of Nivolumab in Association With Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed by Adjuvant Nivolumab for up to 6 Months. NiCOL,COMPLETED,,PHASE1/PHASE2,21.0,ACTUAL,Institut Curie,,1.0,,,f,,,,t,f,f,,,,,,Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.,"Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).",,YES,Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,OTHER,,,,,,,2022,1.0
NCT02474173,,2015-06-15,,,2022-11-03,2015-06-15,2015-06-17,ESTIMATED,,,,,,,2022-11-03,2022-11-04,ACTUAL,2016-01-15,ACTUAL,2016-01-15,2022-11,2022-11-30,2022-10-26,ACTUAL,2022-10-26,2022-10-26,ACTUAL,2022-10-26,,INTERVENTIONAL,,,Onalespib and Paclitaxel in Treating Patients With Advanced Triple Negative Breast Cancer,"Phase 1b Study of HSP90 Inhibitor, AT13387 (Onalespib) in Combination With Paclitaxel in Patients With Advanced, Triple Negative Breast Cancer",TERMINATED,,PHASE1,31.0,ACTUAL,National Cancer Institute (NCI),,1.0,,Drug supply issues,f,,,,t,,,,,,,,,,,,,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,NIH,,,,,,,2022,0.0
NCT04482699,,2020-07-20,,,2021-11-03,2020-07-21,2020-07-22,ACTUAL,,,,,,,2021-11-03,2021-11-11,ACTUAL,2020-12-30,ACTUAL,2020-12-30,2021-11,2021-11-30,2021-09-13,ACTUAL,2021-09-13,2021-09-13,ACTUAL,2021-09-13,,INTERVENTIONAL,,,RAPA-501-Allo Therapy of COVID-19-ARDS,Phase I/Phase II Trial of Allogeneic Hybrid TREG/Th2 Cell (RAPA-501-ALLO) Therapy for COVID-19-Related ARDS,TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,Rapa Therapeutics LLC,,4.0,,Change in eligible patient population,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,INDUSTRY,,,,,,,2021,0.0
NCT04561076,,2020-09-07,,,2022-03-20,2020-09-17,2020-09-23,ACTUAL,,,,,,,2022-03-20,2022-04-01,ACTUAL,2020-12-09,ESTIMATED,2020-12-09,2022-03,2022-03-31,2021-09-18,ESTIMATED,2021-09-18,2021-09-06,ESTIMATED,2021-09-06,,INTERVENTIONAL,,,Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers,"A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Phase I Clinical Study to Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers",WITHDRAWN,,PHASE1,0.0,ACTUAL,Hengenix Biotech Inc,,3.0,,Sponsor strategy,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:43:27.455712,2024-10-15 11:43:27.455712,INDUSTRY,,,,,,,2021,0.0
NCT06034899,,2023-09-06,,,2023-09-19,2023-09-06,2023-09-13,ACTUAL,,,,,,,2023-09-19,2023-09-21,ACTUAL,2023-09-22,ESTIMATED,2023-09-22,2023-09,2023-09-30,2023-11-30,ESTIMATED,2023-11-30,2023-11-30,ESTIMATED,2023-11-30,,INTERVENTIONAL,,,A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants,"A Phase 1, 2-part, Open-label, Randomized, 2-period, 2-sequence, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-986196 Phase 2 Tablet Formulation at Two Dose Levels in Healthy Adult Participants",WITHDRAWN,,PHASE1,0.0,ACTUAL,Bristol-Myers Squibb,,4.0,,Business objectives have changed.,f,,,,f,t,f,,,,,,,,,NO,"BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html",2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,INDUSTRY,,,,,,,2023,0.0
NCT04531878,,2020-08-26,,,2023-02-07,2020-08-26,2020-08-31,ACTUAL,,,,,,,2023-02-07,2023-02-09,ACTUAL,2023-02-08,ESTIMATED,2023-02-08,2023-02,2023-02-28,2023-02-08,ACTUAL,2023-02-08,2023-02-08,ACTUAL,2023-02-08,,INTERVENTIONAL,,,BSEP Function Rescue During Childhood Inhereditary Cholestatic Diseases,Jian-She Wang of Children's Hospital of Fudan University,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Children's Hospital of Fudan University,,1.0,,lack of funding,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,OTHER,,,,,,,2023,0.0
NCT02090998,,2014-03-17,2021-07-02,,2024-06-19,2014-03-18,2014-03-19,ESTIMATED,2021-11-30,2021-12-29,ACTUAL,,,,2024-06-19,2024-07-16,ACTUAL,2014-05,,2014-05-31,2023-05,2023-05-31,2020-03-16,ACTUAL,2020-03-16,2020-03-16,ACTUAL,2020-03-16,,INTERVENTIONAL,,,Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines,A Comparison of the Efficacy of 5% Lidocaine Anesthetic to Provide SPGB Vs. Elavil for the Treatment of Transformed Migraine,TERMINATED,,PHASE4,10.0,ACTUAL,"Rutgers, The State University of New Jersey",,2.0,,no patients during covid pandemic,f,,,,f,,,,,,,,,,,,,2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,OTHER,,,,,,,2020,0.0
NCT04702048,,2021-01-06,,,2021-04-29,2021-01-06,2021-01-08,ACTUAL,,,,,,,2021-04-29,2021-05-05,ACTUAL,2021-02-01,ESTIMATED,2021-02-01,2021-04,2021-04-30,2024-02-01,ESTIMATED,2024-02-01,2024-02-01,ESTIMATED,2024-02-01,,INTERVENTIONAL,PRAVA,,Evaluation of the Retina in Patients With Non-proliferative Diabetic Retinopathy After Aflibercept Injection in the Eye,The Evaluation of Retinal PhotoReceptors And Vasculature in Moderate and Severe Non-proliferative Diabetic Retinopathy Patients After Intravitreal Aflibercept on Using Adaptive Optics Imaging Study (PRAVA) Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Rochester,,2.0,,sponsor withdrew funding,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,OTHER,,,,,,,2024,0.0
NCT03493568,,2018-03-27,,,2024-02-07,2018-04-03,2018-04-10,ACTUAL,,,,,,,2024-02-07,2024-02-09,ACTUAL,2017-02-06,ACTUAL,2017-02-06,2024-02,2024-02-29,2020-07-31,ACTUAL,2020-07-31,2018-03-20,ACTUAL,2018-03-20,,INTERVENTIONAL,Be-OnE,,"Switch From Dual Regimens Based on Dolutegravir Plus a Reverse Transcriptase Inhibitor to E/C/F/TAF in Virologically Suppressed, HIV-1 Infected Patients (Be-OnE)","Open Label, Randomized (1:1) Clinical Trial to Evaluate Switching From Dual Regimens Based on Dolutegravir Plus a Reverse Transcriptase Inhibitor to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed, HIV-1 Infected Patients (Be-OnE Study).",TERMINATED,,PHASE3,100.0,ACTUAL,IRCCS San Raffaele,,2.0,,The futility analysis on 24-week results estimated that there was only 2% probability of verifying the study hypothesis of a higher proportion pat. with no residual viremia through 48w in arm E/C/F/TAF,f,,,,t,f,f,,,,,,,,,YES,Data shared in Scientific Congress (abstract and pubblications),2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,OTHER,,,,,,,2020,0.0
NCT04385095,,2020-04-24,,,2023-01-03,2020-05-11,2020-05-12,ACTUAL,,,,,,,2023-01-03,2023-01-04,ACTUAL,2020-03-16,ACTUAL,2020-03-16,2023-01,2023-01-31,2021-11-16,ACTUAL,2021-11-16,2021-02-17,ACTUAL,2021-02-17,,INTERVENTIONAL,,,Trial of Inhaled Anti-viral (SNG001) for SARS-CoV-2 (COVID-19) Infection,A Randomised Double-blind Placebo-controlled Trial to Determine the Safety and Efficacy of Inhaled SNG001 (IFN-β1a for Nebulisation) for the Treatment of Patients With Confirmed SARS-CoV-2 Infection,COMPLETED,,PHASE2,221.0,ACTUAL,Synairgen Research Ltd.,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,No plan to share data,2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,INDUSTRY,,,,,,,2021,1.0
NCT03750656,,2018-11-16,,,2020-09-03,2018-11-19,2018-11-23,ACTUAL,,,,,,,2020-09-03,2020-09-07,ACTUAL,2018-11-12,ACTUAL,2018-11-12,2020-09,2020-09-30,2020-08-31,ACTUAL,2020-08-31,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,HyTa Stent,,Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation,Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation,TERMINATED,,PHASE4,6.0,ACTUAL,University of Kansas Medical Center,,2.0,,Not accruing patients quickly enough,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,OTHER,,,,,,,2020,0.0
NCT04274023,,2020-02-13,,,2024-01-31,2020-02-15,2020-02-18,ACTUAL,,,,,,,2024-01-31,2024-02-01,ACTUAL,2024-01-29,ACTUAL,2024-01-29,2024-01,2024-01-31,2024-01-29,ACTUAL,2024-01-29,2024-01-29,ACTUAL,2024-01-29,,INTERVENTIONAL,ACCeSs,,Study on TSR-042 in Advanced Clear Cell Sarcoma,Phase II Study on TSR-042 in Advanced Clear Cell Sarcoma,TERMINATED,,PHASE2,3.0,ACTUAL,Italian Sarcoma Group,,1.0,,Difficulty of enrollment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,NETWORK,,,,,,,2024,0.0
NCT04034355,,2019-05-14,2021-08-31,,2021-11-19,2019-07-23,2019-07-26,ACTUAL,2021-11-19,2022-01-26,ACTUAL,,,,2021-11-19,2022-01-26,ACTUAL,2019-01-07,ACTUAL,2019-01-07,2021-11,2021-11-30,2020-08-31,ACTUAL,2020-08-31,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,POLAR-A,Safety analysis set consisting of all randomized patients who received at least one dose of IMP. Patients were analyzed according to the study treatment they actually received.,Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in Adjuvant Colorectal Cancer,"A Phase 3, Double-blind, Multicenter, Placebo-controlled Study of PledOx Used on Top of Modified FOLFOX6 (5-FU/FA and Oxaliplatin) to Prevent Chemotherapy Induced Peripheral Neuropathy (CIPN) in the Adjuvant Treatment of Patients With Stage III or High-risk Stage II Colorectal Cancer",TERMINATED,,PHASE3,301.0,ACTUAL,Egetis Therapeutics,,2.0,,"On 01 March 2020, the Sponsor decided to place recruitment and dosing of patients on hold following interactions with the French regulatory authority, ANSM and the US clinical hold of another study (POLAR-M).",f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 17:44:10.387455,2024-10-16 17:44:10.387455,INDUSTRY,,,,,,,2020,0.0
NCT02706392,,2016-03-01,2022-05-17,,2022-08-11,2016-03-07,2016-03-11,ESTIMATED,2022-08-11,2022-08-31,ACTUAL,,,,2022-08-11,2022-08-31,ACTUAL,2016-03-16,ACTUAL,2016-03-16,2022-08,2022-08-31,2021-09-28,ACTUAL,2021-09-28,2021-05-17,ACTUAL,2021-05-17,,INTERVENTIONAL,,,Genetically Modified T-Cell Therapy in Treating Patients With Advanced ROR1+ Malignancies,Phase I Study of Adoptive Immunotherapy for Advanced ROR1+ Malignancies With Defined Subsets of Autologous T Cells Engineered to Express a ROR1-Specific Chimeric Antigen Receptor,TERMINATED,,PHASE1,21.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,Terminated due to slow accruals.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,OTHER,,,,,,,2021,0.0
NCT04378868,,2020-04-29,,,2023-07-09,2020-05-04,2020-05-07,ACTUAL,,,,,,,2023-07-09,2023-07-11,ACTUAL,2020-05-18,ACTUAL,2020-05-18,2023-07,2023-07-31,2023-02-23,ACTUAL,2023-02-23,2023-01-23,ACTUAL,2023-01-23,,INTERVENTIONAL,PERFECT,,Role of Delay and Antibiotics on Perforation Rate While Waiting Appendectomy,Role of Delay and Antibiotics on PERForation Rate While Waiting appendECTomy - Randomized Non-inferiority Trial,COMPLETED,,PHASE4,1800.0,ACTUAL,Helsinki University Central Hospital,,4.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,OTHER,,,,,,,2023,1.0
NCT02633397,,2015-12-07,2023-05-04,,2023-07-17,2015-12-14,2015-12-17,ESTIMATED,2023-07-17,2023-07-19,ACTUAL,,,,2023-07-17,2023-07-19,ACTUAL,2017-04-11,ACTUAL,2017-04-11,2023-07,2023-07-31,2022-05-04,ACTUAL,2022-05-04,2022-05-04,ACTUAL,2022-05-04,,INTERVENTIONAL,,,A Multi-Center Study of Riociguat in Patients With Sickle Cell Diseases,"A Phase II Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Assess the Safety, Tolerability, and Efficacy of Riociguat in Patients With Sickle Cell Diseases",COMPLETED,,PHASE2,130.0,ACTUAL,University of Pittsburgh,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 22:36:05.61531,2024-10-15 22:36:05.61531,OTHER,,,,,,,2022,1.0
NCT04904913,,2021-05-25,,,2024-08-19,2021-05-26,2021-05-27,ACTUAL,,,,,,,2024-08-19,2024-08-21,ACTUAL,2021-06-08,ACTUAL,2021-06-08,2024-08,2024-08-31,2023-12-06,ACTUAL,2023-12-06,2023-03-29,ACTUAL,2023-03-29,,INTERVENTIONAL,,,A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects,"A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI362 in Chinese Overweight and Obese Subjects",COMPLETED,,PHASE2,328.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,5.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,INDUSTRY,,,,,,,2023,1.0
NCT02921256,,2016-09-30,2023-03-08,,2024-03-28,2016-09-30,2016-10-03,ESTIMATED,2023-06-07,2023-06-09,ACTUAL,,,,2024-03-28,2024-04-24,ACTUAL,2017-01-11,ACTUAL,2017-01-11,2024-03,2024-03-31,2023-09-20,ACTUAL,2023-09-20,2020-04-21,ACTUAL,2020-04-21,,INTERVENTIONAL,,,"Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer",A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer,COMPLETED,,PHASE2,363.0,ACTUAL,National Cancer Institute (NCI),,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,NIH,,,,,,,2023,1.0
NCT03856047,,2019-02-25,2023-02-17,2021-02-18,2024-07-02,2019-02-25,2019-02-27,ACTUAL,2023-07-17,2023-07-18,ACTUAL,,2023-07-18,ACTUAL,2024-07-02,2024-07-05,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2024-07,2024-07-31,2021-03-25,ACTUAL,2021-03-25,2020-03-02,ACTUAL,2020-03-02,,INTERVENTIONAL,,The full analysis set included all randomised participants according to the intention-to-treat principle.,Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.,Investigation of Safety and Efficacy of NNC0174-0833 for Weight Management - a Dose Finding Trial.,COMPLETED,,PHASE2,706.0,ACTUAL,Novo Nordisk A/S,,12.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,INDUSTRY,,,,,,,2021,1.0
NCT04016805,,2019-07-10,2023-05-18,,2023-07-03,2019-07-10,2019-07-11,ACTUAL,2023-07-03,2023-07-24,ACTUAL,,,,2023-07-03,2023-07-24,ACTUAL,2019-08-05,ACTUAL,2019-08-05,2023-07,2023-07-31,2022-05-22,ACTUAL,2022-05-22,2022-05-22,ACTUAL,2022-05-22,,INTERVENTIONAL,,,"Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax","A Phase 2 Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Subjects With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax",TERMINATED,,PHASE2,41.0,ACTUAL,"TG Therapeutics, Inc.","Due to sponsor's business decision, the clinical trial was terminated by the sponsor prematurely. No analysis was done at the termination of the trial, therefore, outcome, and safety data are not available and the numbers of participants analyzed are reported as 0.",3.0,,Strategic/Business decision,f,,,,f,t,f,,,,,,,,,YES,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,INDUSTRY,,,,,,,2022,0.0
NCT01886794,,2013-06-14,,,2024-03-08,2013-06-21,2013-06-26,ESTIMATED,,,,,,,2024-03-08,2024-03-12,ACTUAL,2013-06-06,ACTUAL,2013-06-06,2024-03,2024-03-31,2023-12-11,ACTUAL,2023-12-11,2023-12-11,ACTUAL,2023-12-11,,INTERVENTIONAL,,,Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse,Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With Pelvic Organ Prolapse,TERMINATED,,PHASE4,10.0,ACTUAL,"The University of Texas Medical Branch, Galveston",,3.0,,Collaborator moved and not able to recreate full study team,f,,,,t,t,f,,,,,,,,,,,2024-10-15 11:43:27.455712,2024-10-15 11:43:27.455712,OTHER,,,,,,,2023,0.0
NCT03391882,,2018-01-02,2022-08-03,,2022-11-21,2018-01-02,2018-01-05,ACTUAL,2022-11-21,2022-12-16,ACTUAL,,,,2022-11-21,2022-12-16,ACTUAL,2018-12-19,ACTUAL,2018-12-19,2022-11,2022-11-30,2021-08-11,ACTUAL,2021-08-11,2021-08-11,ACTUAL,2021-08-11,,INTERVENTIONAL,,,A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes),"An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations",COMPLETED,,PHASE3,113.0,ACTUAL,"Sumitomo Pharma America, Inc.",,2.0,,,f,,,,f,t,f,,,t,,,IPD will be made available upon request within 12 months of posting the study results on ct.gov.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,Individual Patient Data (IPD) for this study may be made available upon request via the Clinical Study Data Request site.,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,INDUSTRY,,,,,,,2021,1.0
NCT02023905,,2013-12-24,2022-09-28,,2022-11-29,2013-12-24,2013-12-30,ESTIMATED,2022-11-29,2022-12-29,ACTUAL,,,,2022-11-29,2022-12-29,ACTUAL,2014-03-19,ACTUAL,2014-03-19,2022-11,2022-11-30,2021-09-30,ACTUAL,2021-09-30,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,,,Everolimus With and Without Temozolomide in Adult Low Grade Glioma,PI3K/mTOR Pathway Activation Selected Phase II Study of Everolimus (RAD001) With and Without Temozolomide in the Treatment of Adult Patients With Supratentorial Low-Grade Glioma,TERMINATED,,PHASE2,27.0,ACTUAL,"University of California, San Francisco",Study was closed prematurely due to slow accrual and loss of drug support.,3.0,,Sponsor decision,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,OTHER,,,,,,,2021,0.0
NCT03279952,,2017-09-08,,,2024-07-22,2017-09-08,2017-09-12,ACTUAL,,,,,,,2024-07-22,2024-07-24,ACTUAL,2018-06-01,ACTUAL,2018-06-01,2024-07,2024-07-31,2024-06-30,ACTUAL,2024-06-30,2024-06-30,ACTUAL,2024-06-30,,INTERVENTIONAL,,,Neurophysiological Markers of Pediatric Irritability and Its Response to Intervention,Neurophysiological Markers of Pediatric Irritability and Its Response to Intervention,TERMINATED,,PHASE4,11.0,ACTUAL,Milton S. Hershey Medical Center,,1.0,,challenge in recruitment\],f,,,,f,t,f,,,f,,,,,,UNDECIDED,,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,OTHER,,,,,,,2024,0.0
NCT04614766,,2020-10-13,,,2024-04-25,2020-10-28,2020-11-04,ACTUAL,,,,,,,2024-04-25,2024-04-29,ACTUAL,2022-09-30,ACTUAL,2022-09-30,2024-04,2024-04-30,2024-04-23,ACTUAL,2024-04-23,2024-04-23,ACTUAL,2024-04-23,,INTERVENTIONAL,SPORE-3,,A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors,A Phase 1/2 Trial Using AZEDRA and LUTATHERA in a Dosimetrically-determined Optimal Combination for Therapy of Selected Patients With Midgut Neuroendocrine Tumors,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Iowa,,2.0,,Azedra withdrawn from US market,f,,,,t,t,f,,,,,,phase 1 data: 12 months after identifying the maximum dose phase 2 data: 12 months after last participant last visit,A data usage agreement and privacy contract will need to be completed between investigators and their institutions. Data are to be destroyed after completion / use.,,YES,"Participants must opt in to data sharing. For those that do, imaging, adverse event, and treatment data will be provided.",2024-10-15 11:43:27.455712,2024-10-15 11:43:27.455712,OTHER,,,,,,,2024,0.0
NCT04945824,,2021-06-01,,,2023-02-02,2021-06-22,2021-06-30,ACTUAL,,,,,,,2023-02-02,2023-02-06,ACTUAL,2021-06-01,ACTUAL,2021-06-01,2023-02,2023-02-28,2022-11-01,ACTUAL,2022-11-01,2022-11-01,ACTUAL,2022-11-01,,INTERVENTIONAL,,,A Human Factors Study to Evaluate a Novel Intracanalicular Insertion Device in Healthy Subjects,"An Open-label, Multi-center, Bilateral, Human Factors Study to Evaluate the Utilization and Safety of a Novel Intracanalicular Insertion Device in Healthy Subjects",TERMINATED,,EARLY_PHASE1,2.0,ACTUAL,"Ocular Therapeutix, Inc.",,1.0,,inserter device did not perform as expected,,,,,t,t,t,t,,,,,,,,UNDECIDED,,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,INDUSTRY,,,,,,,2022,0.0
NCT05156229,,2021-12-01,,,2022-08-30,2021-12-01,2021-12-14,ACTUAL,,,,,,,2022-08-30,2022-09-02,ACTUAL,2021-09-06,ACTUAL,2021-09-06,2022-08,2022-08-31,2022-08-24,ACTUAL,2022-08-24,2022-08-24,ACTUAL,2022-08-24,,INTERVENTIONAL,Part B,,A Phase 1/2a Study of CDK-003 in Patients With Cutaneous T-Cell Lymphoma (CTCL).,"A Phase 1/2a Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CDK-003 in Healthy Adult Participants and Intralesionally Administered CDK-003 in Patients With Cutaneous T-cell Lymphoma (CTCL)",TERMINATED,,PHASE1,2.0,ACTUAL,Codiak BioSciences,,1.0,,PK/PD from two patients plus the healthy volunteer data confirmed the RP2D and manageable safety profile. Proceeding to Phase II did not require additional data from this Phase I Dose-Finding study.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,INDUSTRY,,,,,,,2022,0.0
NCT02575339,,2015-10-09,2021-12-17,,2022-07-22,2015-10-12,2015-10-14,ESTIMATED,2022-03-03,2022-03-31,ACTUAL,,,,2022-07-22,2022-07-26,ACTUAL,2016-07-18,ACTUAL,2016-07-18,2022-07,2022-07-31,2020-11-24,ACTUAL,2020-11-24,2018-06-26,ACTUAL,2018-06-26,,INTERVENTIONAL,,This study was terminated at Phase I.The official reason for study termination was Funder Decision due to lack of accrual. Dose level 1 has 7 subjects since one of the subjects (subject #6) had to come off treatment early but did not have a DLT and so the subject was replaced to have the appropriate number of subjects for the dose decision.,MLN0128 Compared to Sorafenib in Advanced or Metastatic Hepatocellular Carcinoma,An Open Label Randomized Phase I/II Trial of MLN0128 Compared to Sorafenib in Patients With Advanced or Metastatic Hepatocellular Carcinoma: Big Ten Cancer Research Consortium BTCRC-GI13-002,TERMINATED,,PHASE1/PHASE2,11.0,ACTUAL,Big Ten Cancer Research Consortium,,3.0,,Funder Decision,,,,,t,t,f,,,,,,,,,,,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,OTHER,,,,,,,2020,0.0
NCT04374279,,2020-05-04,,,2021-03-02,2020-05-04,2020-05-05,ACTUAL,,,,,,,2021-03-02,2021-03-05,ACTUAL,2021-04,ESTIMATED,2021-04-30,2021-03,2021-03-31,2022-01,ESTIMATED,2022-01-31,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,RECOVER,,Trial to Promote Recovery From COVID-19 With Endocrine Therapy,A Phase II Trial to Promote Recovery From COVID-19 With Endocrine Therapy,WITHDRAWN,,PHASE2,0.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,2.0,,Limited resources.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,OTHER,,,,,,,2022,0.0
NCT04403763,,2020-05-01,2023-12-04,,2024-01-16,2020-05-21,2020-05-27,ACTUAL,2024-01-16,2024-02-06,ACTUAL,,,,2024-01-16,2024-02-06,ACTUAL,2020-07-27,ACTUAL,2020-07-27,2024-01,2024-01-31,2022-12-05,ACTUAL,2022-12-05,2022-12-05,ACTUAL,2022-12-05,,INTERVENTIONAL,,The intent-to-treat (ITT) population consists of all randomized participants.,Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia,"A First-in-Human, Phase 1/2, Dose-ascending, Multicenter, Masked, Randomized, Vehicle-controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AGN-241622 in Healthy Participants and Participants With Presbyopia (Stage 1 and Stage 2) and Efficacy in Participants With Presbyopia (Stage 2)",TERMINATED,,PHASE1/PHASE2,80.0,ACTUAL,AbbVie,,7.0,,Strategic considerations,f,,,,t,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,INDUSTRY,,,,,,,2022,0.0
NCT03287245,,2017-09-08,2021-02-19,,2021-12-07,2017-09-15,2017-09-19,ACTUAL,2021-05-03,2021-05-27,ACTUAL,,,,2021-12-07,2021-12-08,ACTUAL,2018-02-21,ACTUAL,2018-02-21,2021-12,2021-12-31,2020-03-03,ACTUAL,2020-03-03,2020-03-03,ACTUAL,2020-03-03,,INTERVENTIONAL,,,"A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Participants With Hydroxyurea-Resistant/Intolerant Polycythemia Vera","A Phase II, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Patients With Hydroxyurea-Resistant/Intolerant Polycythemia Vera",TERMINATED,,PHASE2,27.0,ACTUAL,Hoffmann-La Roche,,1.0,,The Sponsor decided to discontinue the development of idasanutlin in the polycythemia vera indication.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,INDUSTRY,,,,,,,2020,0.0
NCT03176693,,2017-05-31,2022-01-08,,2023-11-02,2017-06-02,2017-06-05,ACTUAL,2023-11-02,2023-11-20,ACTUAL,,,,2023-11-02,2023-11-20,ACTUAL,2017-05-05,ACTUAL,2017-05-05,2023-11,2023-11-30,2021-10-10,ACTUAL,2021-10-10,2020-01-31,ACTUAL,2020-01-31,,INTERVENTIONAL,,,Preoperative Alpha Blockade for Pheochromocytoma,Randomized Controlled Trial of Preoperative Alpha Blockade for Pheochromocytoma,COMPLETED,,PHASE3,39.0,ACTUAL,"University of California, Los Angeles",,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,OTHER,,,,,,,2021,1.0
NCT02886962,,2016-08-29,,,2024-08-16,2016-08-29,2016-09-01,ESTIMATED,,,,,,,2024-08-16,2024-08-20,ACTUAL,2017-07-12,ACTUAL,2017-07-12,2024-08,2024-08-31,2023-12-01,ACTUAL,2023-12-01,2023-12-01,ACTUAL,2023-12-01,,INTERVENTIONAL,AVKDIAL,,Oral Anticoagulation in Haemodialysis Patients,Study of the Benefit / Risk Ratio of Oral Anticoagulation in Hemodialysis Patients With Atrial Fibrillation,TERMINATED,,PHASE4,50.0,ACTUAL,"University Hospital, Strasbourg, France",,2.0,,not enough patients,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,OTHER,,,,,,,2023,0.0
NCT05946551,,2023-07-12,,,2024-08-20,2023-07-12,2023-07-14,ACTUAL,,,,,,,2024-08-20,2024-08-21,ACTUAL,2024-03-08,ACTUAL,2024-03-08,2024-08,2024-08-31,2024-06-24,ACTUAL,2024-06-24,2024-06-24,ACTUAL,2024-06-24,,INTERVENTIONAL,,,Treatment of Long CoronaVirus Disease (COVID) (TLC) Feasibility Trial,"Feasibility Assessment of a Decentralized Platform Adaptive Double-Blind, Randomized Controlled Trial Investigating Repurposed Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC)",TERMINATED,,PHASE3,5.0,ACTUAL,Emory University,,2.0,,Study was terminated due to lack of funding.,f,,,,t,t,f,,,,,,Datasets may be available following final analyses and publication.,Proposals should be directed to tiffany.austin.walker@emory.edu.,,YES,De-identified datasets may be available to external researchers following final analyses. Requests will be evaluated on a case-by-case basis by PI. No data will be released without proof of Institutional Review Board (IRB) approval or determination. Agreements as required by local policies will be completed when necessary.,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,OTHER,,,,,,,2024,0.0
NCT03218722,,2017-07-12,,,2022-11-07,2017-07-12,2017-07-14,ACTUAL,,,,,,,2022-11-07,2022-11-08,ACTUAL,2017-12-29,ACTUAL,2017-12-29,2022-11,2022-11-30,2022-06-15,ACTUAL,2022-06-15,2021-08-31,ACTUAL,2021-08-31,,INTERVENTIONAL,PROCOAG,,Early Administration of Prothrombin Concentrate Complex in Patients With Acute Hemorrhage Following Severe Trauma,Impact of Early Administration of Prothrombin Concentrate Complex in Patients With Acute Hemorrhage Following Severe Trauma,COMPLETED,,PHASE3,350.0,ACTUAL,"University Hospital, Grenoble",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,OTHER,,,,,,,2022,0.0
NCT04223778,,2020-01-08,2022-08-22,,2024-09-12,2020-01-08,2020-01-10,ACTUAL,2022-08-22,2022-09-19,ACTUAL,,,,2024-09-12,2024-09-27,ACTUAL,2020-02-18,ACTUAL,2020-02-18,2024-09,2024-09-30,2024-08-26,ACTUAL,2024-08-26,2021-09-08,ACTUAL,2021-09-08,,INTERVENTIONAL,,,Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017),"A Phase 3 Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Antiretroviral Therapy",COMPLETED,,PHASE3,672.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,INDUSTRY,,,,,,,2024,1.0
NCT02098161,,2014-03-21,2023-05-09,,2023-05-09,2014-03-24,2014-03-27,ESTIMATED,2023-05-09,2023-06-06,ACTUAL,,,,2023-05-09,2023-06-06,ACTUAL,2014-12-18,ACTUAL,2014-12-18,2023-05,2023-05-31,2022-05-19,ACTUAL,2022-05-19,2022-05-19,ACTUAL,2022-05-19,,INTERVENTIONAL,,,"LCL161 in Treating Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocytosis Myelofibrosis","Open Label Phase 2 Single Agent Study of LCL-161 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF)",COMPLETED,,PHASE2,50.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,OTHER,,,,,,,2022,1.0
NCT03889379,,2019-01-31,,,2021-08-06,2019-03-22,2019-03-26,ACTUAL,,,,,,,2021-08-06,2021-08-13,ACTUAL,2019-01-20,ACTUAL,2019-01-20,2021-08,2021-08-31,2021-06-20,ESTIMATED,2021-06-20,2021-06-20,ESTIMATED,2021-06-20,,INTERVENTIONAL,,,Albuterol and Immune Cell Composition,Albuterol and Immune Cell Composition,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Arizona,,1.0,,Team decided not to initiate study.,f,,,,f,t,f,,,t,,,,,,UNDECIDED,,2024-10-14 21:33:25.174097,2024-10-14 21:33:25.174097,OTHER,,,,,,,2021,0.0
NCT03895502,,2019-03-27,,,2023-10-02,2019-03-28,2019-03-29,ACTUAL,,,,,,,2023-10-02,2023-10-04,ACTUAL,2019-05-27,ACTUAL,2019-05-27,2023-10,2023-10-31,2023-08-31,ACTUAL,2023-08-31,2023-06-30,ACTUAL,2023-06-30,,INTERVENTIONAL,ONCO DVT,,Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study,Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study,COMPLETED,,PHASE4,605.0,ACTUAL,"Kyoto University, Graduate School of Medicine",,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,OTHER,,,,,,,2023,1.0
NCT03756922,,2018-11-27,,,2020-01-30,2018-11-27,2018-11-28,ACTUAL,,,,,,,2020-01-30,2020-02-05,ACTUAL,2018-11-27,ACTUAL,2018-11-27,2020-01,2020-01-31,2020-02,ESTIMATED,2020-02-29,2020-02,ESTIMATED,2020-02-29,,INTERVENTIONAL,,,A DDI Study of FDL169 and FDL176 in Healthy Subjects,"A Phase 1/2, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects and in Cystic Fibrosis Subjects Homozygous for the F508del-CFTR Mutation",SUSPENDED,,PHASE1/PHASE2,78.0,ESTIMATED,Flatley Discovery Lab LLC,,4.0,,Business reasons,f,,,,t,f,f,,,,,,,,,,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,OTHER,,,,,,,2020,0.0
NCT03022578,,2017-01-13,2022-05-25,2022-01-05,2022-07-14,2017-01-13,2017-01-16,ESTIMATED,2022-07-14,2022-08-10,ACTUAL,2022-07-14,2022-08-10,ACTUAL,2022-07-14,2022-08-10,ACTUAL,2017-11-07,ACTUAL,2017-11-07,2022-07,2022-07-31,2021-02-16,ACTUAL,2021-02-16,2021-02-16,ACTUAL,2021-02-16,,INTERVENTIONAL,,,Laser Interstitial Thermal Therapy and Lomustine in Treating Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma,Phase II Study of Laser Interstitial Thermal Therapy (LITT) in Recurrent Glioblastoma,TERMINATED,,PHASE2,7.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Slow accrual,f,,,,f,t,f,,,,,,,,,,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,OTHER,,,,,,,2021,0.0
NCT03956589,,2019-05-02,,,2020-04-07,2019-05-17,2019-05-20,ACTUAL,,,,,,,2020-04-07,2020-04-08,ACTUAL,2018-10-01,ACTUAL,2018-10-01,2020-04,2020-04-30,2020-04-01,ACTUAL,2020-04-01,2020-04-01,ACTUAL,2020-04-01,,INTERVENTIONAL,,,Functional Respiratory Imaging and Orkambi in CF,Functional Respiratory Imaging (FRI) to Assess the Short-term Effect of the Product ORKAMBI (Lumacaftor/ Ivacaftor) on Lung Function in ORKAMBInaive Patients With Cystic Fibrosis Homozygous for Phe508del,TERMINATED,,PHASE4,12.0,ACTUAL,"University Hospital, Antwerp",,1.0,,Patient inclusion has stopped after interim analysis.,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,OTHER,,,,,,,2020,0.0
NCT04233502,,2020-01-15,,,2021-03-10,2020-01-15,2020-01-18,ACTUAL,,,,,,,2021-03-10,2021-03-12,ACTUAL,2020-09,ESTIMATED,2020-09-30,2020-01,2020-01-31,2022-12,ESTIMATED,2022-12-31,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,ASD,,Efficacy and Safety of Slenyto for Insomnia in Children With ASD,"A Randomized, Placebo Controlled Study to Investigate the Efficacy and Safety of Slenyto® to Alleviate Sleep Disturbances in Children With Autism Spectrum Disorder",WITHDRAWN,,PHASE3,0.0,ACTUAL,Neurim Pharmaceuticals Ltd.,,2.0,,Study was not initiated it was decided to cancel this study,,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,INDUSTRY,,,,,,,2022,0.0
NCT02702518,,2016-03-03,2021-06-10,,2021-08-10,2016-03-03,2016-03-08,ESTIMATED,2021-07-16,2021-08-10,ACTUAL,,,,2021-08-10,2021-09-05,ACTUAL,2016-04,,2016-04-30,2021-08,2021-08-31,2020-04-08,ACTUAL,2020-04-08,2020-04-08,ACTUAL,2020-04-08,,INTERVENTIONAL,,,rhDNase Eye Drops in Patients With Ocular Graft-Vs.-Host Disease,"A Phase I/II Randomized Placebo-Controlled, Double-Blind, Single-Center, Tolerability and Preliminary Efficacy Clinical Trial of Recombinant Human Deoxyribonuclease (rhDNase) Eye Drops in Patients With Ocular Graft-Vs.-Host Disease",TERMINATED,,PHASE1/PHASE2,58.0,ACTUAL,University of Illinois at Chicago,,2.0,,The DSMB committee recommended closing the trial because of the COVID-19 risk in this at-risk oGVHD population if they came for study visits.,f,,,,t,,,,,,,,,,,NO,,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,OTHER,,,,,,,2020,0.0
NCT05683600,,2022-12-25,,,2023-09-26,2023-01-11,2023-01-13,ACTUAL,,,,,,,2023-09-26,2023-09-28,ACTUAL,2022-12-29,ACTUAL,2022-12-29,2022-12,2022-12-31,2023-07-12,ACTUAL,2023-07-12,2023-07-12,ACTUAL,2023-07-12,,INTERVENTIONAL,,,Efficacy and Safety of COVID-19 Vaccine as Booster Vaccination in Adults 18 Years of Age or Older,"A Multicentre, Randomized, Double-blinded, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 as Booster Vaccination in Adults 18 Years of Age or Older",TERMINATED,,PHASE3,3000.0,ACTUAL,"Guangzhou Patronus Biotech Co., Ltd.",,2.0,,According to the development of the novel coronavirus epidemic situation and the company's R\&D decision,f,,,,t,f,f,,,,,,,,,,,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,INDUSTRY,,,,,,,2023,0.0
NCT03433755,,2018-01-18,2021-07-26,2021-03-01,2023-03-23,2018-02-08,2018-02-15,ACTUAL,2021-07-26,2021-08-20,ACTUAL,2021-03-01,2021-03-03,ACTUAL,2023-03-23,2023-03-27,ACTUAL,2019-05-09,ACTUAL,2019-05-09,2023-03,2023-03-31,2020-05-09,ACTUAL,2020-05-09,2020-04-24,ACTUAL,2020-04-24,,INTERVENTIONAL,,Full Analysis Set: All participants who were randomized and received at least 1 dose of study drug.,Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia,"A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety and Efficacy of Evolocumab (AMG 145) in Addition to Optimal Stable Background Statin Therapy in Chinese Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia",TERMINATED,,PHASE3,259.0,ACTUAL,Amgen,,4.0,,Prematurely Discontinued Amgen decision,f,,,,,t,f,,,t,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,INDUSTRY,,,,,,,2020,0.0
NCT02463305,,2015-05-27,,,2023-04-03,2015-06-01,2015-06-04,ESTIMATED,,,,,,,2023-04-03,2023-04-06,ACTUAL,2022-08,ESTIMATED,2022-08-31,2023-04,2023-04-30,2023-03-01,ACTUAL,2023-03-01,2023-03-01,ACTUAL,2023-03-01,,INTERVENTIONAL,,,Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD),Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD),WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,"University of Colorado, Denver",,3.0,,inability to enroll,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,OTHER,,,,,,,2023,0.0
NCT04469062,,2020-07-10,,,2021-05-04,2020-07-10,2020-07-13,ACTUAL,,,,,,,2021-05-04,2021-05-06,ACTUAL,2021-04-20,ESTIMATED,2021-04-20,2021-05,2021-05-31,2024-06-05,ESTIMATED,2024-06-05,2024-03-13,ESTIMATED,2024-03-13,,INTERVENTIONAL,LUCENT-ACT,,A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis,"A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants With Moderately to Severely Active Ulcerative Colitis",WITHDRAWN,,PHASE3,0.0,ACTUAL,Eli Lilly and Company,,3.0,,"The trial was terminated secondary to a business decision, the original scientific question rendered moot by the external scientific community.",f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,INDUSTRY,,,,,,,2024,0.0
NCT03614494,,2018-07-29,2023-01-07,,2023-11-28,2018-07-29,2018-08-03,ACTUAL,2023-11-28,2024-05-06,ACTUAL,,,,2023-11-28,2024-05-06,ACTUAL,2018-08-20,ACTUAL,2018-08-20,2023-11,2023-11-30,2022-10-05,ACTUAL,2022-10-05,2022-10-05,ACTUAL,2022-10-05,,INTERVENTIONAL,,,Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception,Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception: Randomised Controlled Trial,COMPLETED,,PHASE2/PHASE3,860.0,ACTUAL,The University of Hong Kong,,2.0,,,f,,,,f,f,f,,,,,,starting 6 months after publication of results,To be assessed and endorsed by the investigation team based on the exact study protocol suggested by the other researchers.,,YES,To be assessed and endorsed by the investigation team based on the exact study protocol suggested by the other researchers.,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,OTHER,,,,,,,2022,1.0
NCT03018223,,2017-01-10,2019-12-06,,2021-09-14,2017-01-10,2017-01-11,ESTIMATED,2020-01-10,2020-01-21,ACTUAL,,,,2021-09-14,2021-09-16,ACTUAL,2017-01-31,ACTUAL,2017-01-31,2021-09,2021-09-30,2021-03-18,ACTUAL,2021-03-18,2018-12-15,ACTUAL,2018-12-15,,INTERVENTIONAL,,All participants,Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haplo PBSCT,A Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haploidentical Peripheral Blood Stem Cell Transplantation,COMPLETED,,PHASE1,32.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,OTHER,,,,,,,2021,1.0
NCT04177108,,2019-11-07,2024-02-26,,2024-02-26,2019-11-22,2019-11-26,ACTUAL,2024-02-26,2024-03-27,ACTUAL,,,,2024-02-26,2024-03-27,ACTUAL,2019-11-25,ACTUAL,2019-11-25,2024-02,2024-02-29,2023-02-28,ACTUAL,2023-02-28,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all participants randomized in this study.,A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer,"A Phase III, Double-blind, Placebo-controlled, Randomized Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Patients With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer",COMPLETED,,PHASE3,242.0,ACTUAL,Hoffmann-La Roche,,5.0,,,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,INDUSTRY,,,,,,,2023,1.0
NCT06161792,,2023-10-23,,,2023-11-29,2023-11-29,2023-12-08,ACTUAL,,,,,,,2023-11-29,2023-12-08,ACTUAL,2019-11-07,ACTUAL,2019-11-07,2023-11,2023-11-30,2022-04-20,ACTUAL,2022-04-20,2022-03-14,ACTUAL,2022-03-14,,INTERVENTIONAL,VMS,,Evaluate RCN3028 in Treatment of Drug-Induced VMS in Breast Cancer,"A Randomized, Placebo-Controlled, Double-Blind, Parallel, Phase 2 Study to Evaluate the Efficacy and Safety of RCN3028 in Treatment of Drug-Induced Moderate to Severe Vasomotor Symptoms in Breast Cancer Subjects",TERMINATED,,PHASE2,10.0,ACTUAL,"Yung Shin Pharm. Ind. Co., Ltd.",,2.0,,"Difficulty in recruiting breast cancer patients, leading to a slow rate of case enrollment.",f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,INDUSTRY,,,,,,,2022,0.0
NCT03992326,,2019-06-18,,,2021-03-16,2019-06-19,2019-06-20,ACTUAL,,,,,,,2021-03-16,2021-03-18,ACTUAL,2019-09-01,ACTUAL,2019-09-01,2021-03,2021-03-31,2021-03-05,ACTUAL,2021-03-05,2021-03-05,ACTUAL,2021-03-05,,INTERVENTIONAL,,,Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes in Solid Tumors,Phase Ib Study To Assess The Feasibility And Safety Of Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes In Advanced Solid Tumors,TERMINATED,,PHASE1,6.0,ACTUAL,Centre Hospitalier Universitaire Vaudois,,1.0,,Internal competitive study that is open,f,,,,t,f,f,,,,,,,,,,,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,OTHER,,,,,,,2021,0.0
NCT04217317,,2019-12-31,,,2024-08-19,2019-12-31,2020-01-03,ACTUAL,,,,,,,2024-08-19,2024-08-21,ACTUAL,2020-09-16,ACTUAL,2020-09-16,2024-07,2024-07-31,2024-07-11,ACTUAL,2024-07-11,2023-04-21,ACTUAL,2023-04-21,,INTERVENTIONAL,,,CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma,"Pilot Study of CPI-613, in Combination With Bendamustine, in Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma",TERMINATED,,PHASE2,6.0,ACTUAL,Wake Forest University Health Sciences,,1.0,,Low accruals,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,OTHER,,,,,,,2024,0.0
NCT03987919,,2019-06-14,2022-01-21,,2022-01-21,2019-06-14,2019-06-17,ACTUAL,2022-01-21,2022-02-14,ACTUAL,,,,2022-01-21,2022-02-14,ACTUAL,2019-07-30,ACTUAL,2019-07-30,2021-07,2021-07-31,2021-02-15,ACTUAL,2021-02-15,2021-01-28,ACTUAL,2021-01-28,,INTERVENTIONAL,SURPASS-2,All randomized participants who received at least one dose of study drug.,A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes,"A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of Tirzepatide Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes",COMPLETED,,PHASE3,1879.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,INDUSTRY,,,,,,,2021,1.0
NCT05049161,,2021-08-31,,,2022-07-04,2021-09-10,2021-09-17,ACTUAL,,,,,,,2022-07-04,2022-07-07,ACTUAL,2021-08-27,ACTUAL,2021-08-27,2022-07,2022-07-31,2022-05-18,ACTUAL,2022-05-18,2022-05-18,ACTUAL,2022-05-18,,INTERVENTIONAL,,,A Long-term Extension of Study GNC-401,A Long-term Extension of Study GNC-401 With Temelimab in Patients With Relapsing Forms of Multiple Sclerosis (RMS) Under Treatment With Rituximab,TERMINATED,,PHASE2,33.0,ACTUAL,GeNeuro SA,,3.0,,Drug product unavailability,f,,,,t,f,f,,,,,,,,,,,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,INDUSTRY,,,,,,,2022,0.0
NCT03545191,,2018-05-22,2022-01-07,2020-10-20,2022-03-24,2018-05-22,2018-06-04,ACTUAL,2022-03-24,2022-03-25,ACTUAL,2022-03-24,2022-03-25,ACTUAL,2022-03-24,2022-03-25,ACTUAL,2018-06-04,ACTUAL,2018-06-04,2022-03,2022-03-31,2020-02-25,ACTUAL,2020-02-25,2020-01-25,ACTUAL,2020-01-25,,INTERVENTIONAL,,,Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder,"Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder",COMPLETED,,PHASE3,930.0,ACTUAL,Idorsia Pharmaceuticals Ltd.,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,INDUSTRY,,,,,,,2020,1.0
NCT01937247,,2013-08-29,,,2022-02-23,2013-09-04,2013-09-09,ESTIMATED,,,,,,,2022-02-23,2022-03-09,ACTUAL,2018-05-18,ACTUAL,2018-05-18,2022-02,2022-02-28,2020-10-30,ACTUAL,2020-10-30,2020-10-30,ACTUAL,2020-10-30,,INTERVENTIONAL,,,Redesigned Process in the Operating Room,Redesigned Process in the Operating Room: Monitoring and Evaluating Success of Reducing Non Operative Time,COMPLETED,,PHASE2/PHASE3,120.0,ACTUAL,American University of Beirut Medical Center,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,OTHER,,,,,,,2020,1.0
NCT05661669,,2022-11-21,,,2024-06-06,2022-12-14,2022-12-22,ACTUAL,,,,,,,2024-06-06,2024-06-10,ACTUAL,2023-10-25,ACTUAL,2023-10-25,2024-06,2024-06-30,2024-06-06,ACTUAL,2024-06-06,2024-06-06,ACTUAL,2024-06-06,,INTERVENTIONAL,,,Ketamine for the Treatment for Alcohol Use Disorder in the ED,"Ketamine for the Treatment for Alcohol Use Disorder in the Emergency Department: A Pilot Double-blind, Placebo-controlled Randomized Clinical Trial",WITHDRAWN,,PHASE2,0.0,ACTUAL,Brigham and Women's Hospital,,2.0,,"After months of screening, we screened 175 individuals, only 3 were eligible, 2 declined, and 1 was moved to a different floor before study activities were able to take place.",f,,,,t,t,f,,,t,,,,,,,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,OTHER,,,,,,,2024,0.0
NCT03594747,,2018-07-03,2023-09-19,2021-09-24,2024-02-28,2018-07-19,2018-07-20,ACTUAL,2023-10-13,2023-10-17,ACTUAL,,2023-10-17,ACTUAL,2024-02-28,2024-03-01,ACTUAL,2018-07-30,ACTUAL,2018-07-30,2024-02,2024-02-29,2023-04-28,ACTUAL,2023-04-28,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,,Intent-to-treat (ITT) analysis set included all participants who were randomized. Data are presented as of the study completion data cut-off date of 28APR2023.,A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer,"A Phase 3, Multicenter, Randomized Open-Label Study to Compare the Efficacy and Safety of Tislelizumab (BGB A317, Anti-PD1 Antibody) Combined With Paclitaxel Plus Carboplatin or Nab Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin Alone as First-Line Treatment for Untreated Advanced Squamous Non-small Cell Lung Cancer",COMPLETED,,PHASE3,360.0,ACTUAL,BeiGene,,3.0,,,f,,,,t,t,f,,,t,,,,,,YES,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,INDUSTRY,,,,,,,2023,1.0
NCT04473716,,2020-07-14,,,2023-11-21,2020-07-14,2020-07-16,ACTUAL,,,,,,,2023-11-21,2023-11-22,ACTUAL,2020-07-30,ACTUAL,2020-07-30,2023-11,2023-11-30,2023-09-30,ACTUAL,2023-09-30,2021-04-12,ACTUAL,2021-04-12,,INTERVENTIONAL,,,Neoadjuvant Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients,Neoadjuvant Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients: A Single-arm Phase I Trial,COMPLETED,,PHASE1,20.0,ACTUAL,Shanghai Jiao Tong University School of Medicine,,1.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,OTHER,,,,,,,2023,1.0
NCT04853134,,2021-04-19,,,2022-02-17,2021-04-19,2021-04-21,ACTUAL,,,,,,,2022-02-17,2022-03-04,ACTUAL,2020-11-01,ESTIMATED,2020-11-01,2021-04,2021-04-30,2021-12-01,ESTIMATED,2021-12-01,2021-12-01,ESTIMATED,2021-12-01,,INTERVENTIONAL,,,Proxalutamide Treatment for COVID-19 Female Outpatients,Proxalutamide Treatment for COVID-19 Female Outpatients,WITHDRAWN,,PHASE3,0.0,ACTUAL,"Applied Biology, Inc.",,2.0,,This study was combined with another study,f,,,,f,f,f,,,,,,,,,,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,INDUSTRY,,,,,,,2021,0.0
NCT04395716,,2020-05-19,,,2021-04-06,2020-05-19,2020-05-20,ACTUAL,,,,,,,2021-04-06,2021-04-08,ACTUAL,2020-01,ESTIMATED,2020-01-31,2021-04,2021-04-30,2021-11,ESTIMATED,2021-11-30,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,A Study of ResCure™ to Treat COVID-19 Infection,A Phase I Study of ResCure™ to Treat COVID-19 Infection,WITHDRAWN,,PHASE1,0.0,ACTUAL,ProgenaBiome,,1.0,,Not ever started,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,OTHER,,,,,,,2021,0.0
NCT02872519,,2016-07-26,,,2018-06-04,2016-08-16,2016-08-19,ESTIMATED,,,,,,,2018-06-04,2018-06-06,ACTUAL,2018-06,ESTIMATED,2018-06-30,2018-06,2018-06-30,2020-08,ESTIMATED,2020-08-31,2019-08,ESTIMATED,2019-08-31,,INTERVENTIONAL,,,PET Imaging of Ovarian Carcinoma With 18F-FSPG,PET Imaging of Ovarian Carcinoma With 18F-FSPG,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Vanderbilt-Ingram Cancer Center,,1.0,,No funding,f,,,,,t,f,,,,,,,,,,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,OTHER,,,,,,,2020,0.0
NCT05002114,,2021-08-02,,,2022-06-30,2021-08-10,2021-08-12,ACTUAL,,,,,,,2022-06-30,2022-07-06,ACTUAL,2023-01,ESTIMATED,2023-01-31,2022-06,2022-06-30,2023-01,ESTIMATED,2023-01-31,2023-01,ESTIMATED,2023-01-31,,INTERVENTIONAL,CBD001,,Evaluation of a Specific Transdermal Cannabidiol Product for Chronic Musculoskeletal Joint Pain.,Evaluation of a Specific Transdermal Cannabidiol Product for Chronic Musculoskeletal Joint Pain.,WITHDRAWN,,PHASE1,0.0,ACTUAL,Louisiana State University Health Sciences Center Shreveport,,2.0,,there were issues with the primary study material that prohibited continuation at this time,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,OTHER,,,,,,,2023,0.0
NCT04353817,,2020-04-16,2022-05-16,,2022-07-01,2020-04-16,2020-04-20,ACTUAL,2022-07-01,2022-07-26,ACTUAL,,,,2022-07-01,2022-07-26,ACTUAL,2020-06-19,ACTUAL,2020-06-19,2022-07,2022-07-31,2021-05-17,ACTUAL,2021-05-17,2021-05-17,ACTUAL,2021-05-17,,INTERVENTIONAL,,,A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes,"A Phase 3b, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)",COMPLETED,,PHASE3,121.0,ACTUAL,Vertex Pharmaceuticals Incorporated,,2.0,,,f,,,,,t,f,,,t,,,,,,NO,Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,INDUSTRY,,,,,,,2021,1.0
NCT04722601,,2020-11-02,2024-03-27,,2024-05-08,2021-01-20,2021-01-25,ACTUAL,2024-05-08,2024-05-16,ACTUAL,,,,2024-05-08,2024-05-16,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2024-05,2024-05-31,2023-03-31,ACTUAL,2023-03-31,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,,,"A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma","A Multicenter, Single-Arm, Phase I/II Dose Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Minimally-Pretreated Follicular Lymphoma",TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,University of Chicago,,6.0,,funding,f,,,,f,t,f,,,,,,,,,,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,OTHER,,,,,,,2023,0.0
NCT04173338,,2019-11-14,,,2022-06-10,2019-11-20,2019-11-21,ACTUAL,,,,,,,2022-06-10,2022-06-14,ACTUAL,2020-01-23,ACTUAL,2020-01-23,2022-06,2022-06-30,2022-03-28,ACTUAL,2022-03-28,2022-03-28,ACTUAL,2022-03-28,,INTERVENTIONAL,,,"Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma","Phase I Study of Cabozantinib in Combination With Pemetrexed in Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC), Urothelial Cancer and Advanced Malignant Mesothelioma",TERMINATED,,PHASE1,9.0,ACTUAL,Augusta University,,1.0,,Closed by IRB on 3/28/22,f,,,,t,t,f,,,,,,,,,,,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,OTHER,,,,,,,2022,0.0
NCT03087201,,2017-03-06,,,2020-12-09,2017-03-16,2017-03-22,ACTUAL,,,,,,,2020-12-09,2020-12-10,ACTUAL,2018-04-05,ACTUAL,2018-04-05,2020-07,2020-07-31,2020-11-20,ACTUAL,2020-11-20,2020-11-20,ACTUAL,2020-11-20,,INTERVENTIONAL,CANNA-TICS,,CANNAbinoids in the Treatment of TICS (CANNA-TICS),A Randomized Multi-centre Double-blind Placebo Controlled Trial to Demonstrate the Efficacy and Safety of Nabiximols in the Treatment of Adults With Chronic Tic Disorders,COMPLETED,,PHASE3,98.0,ACTUAL,Hannover Medical School,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,OTHER,,,,,,,2020,1.0
NCT04339426,,2020-04-07,,,2022-02-16,2020-04-07,2020-04-09,ACTUAL,,,,,,,2022-02-16,2022-03-04,ACTUAL,2020-04-20,ACTUAL,2020-04-20,2022-02,2022-02-28,2022-02-11,ACTUAL,2022-02-11,2022-02-11,ACTUAL,2022-02-11,,INTERVENTIONAL,,,Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection,"Open-Label, Non-Randomized Study to Evaluate Anti-Malarial/Anti-Infective Combination Therapies in Patients With Confirmed COVID-19 Infection",TERMINATED,,PHASE2,3.0,ACTUAL,HonorHealth Research Institute,,1.0,,Closed due to poor enrollment,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,OTHER,,,,,,,2022,0.0
NCT05069012,,2021-09-25,,,2024-05-06,2021-09-25,2021-10-06,ACTUAL,,,,,,,2024-05-06,2024-05-07,ACTUAL,2021-11-15,ACTUAL,2021-11-15,2024-05,2024-05-31,2022-07-23,ACTUAL,2022-07-23,2022-07-23,ACTUAL,2022-07-23,,INTERVENTIONAL,,,Intrathecal Morphine for Cesarean Delivery,Optimal Dose of Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery,COMPLETED,,PHASE4,72.0,ACTUAL,Beth Israel Deaconess Medical Center,,3.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,OTHER,,,,,,,2022,1.0
NCT03819231,,2019-01-16,,,2024-06-12,2019-01-25,2019-01-28,ACTUAL,,,,,,,2024-06-12,2024-06-14,ACTUAL,2018-10-10,ACTUAL,2018-10-10,2024-06,2024-06-30,2023-12-31,ACTUAL,2023-12-31,2023-12-31,ACTUAL,2023-12-31,,INTERVENTIONAL,MOXY,,Mindfulness Training Plus Oxytocin Effects on Smoking Behavior,Mindfulness Training Plus Oxytocin to Reduce Smoking and Craving Among Smokers in Withdrawal,TERMINATED,,PHASE2/PHASE3,20.0,ACTUAL,University of Southern California,,3.0,,Study completed early due to COVID-19 pandemic regulations.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,OTHER,,,,,,,2023,0.0
NCT04932941,,2021-06-18,2023-04-26,,2023-06-12,2021-06-18,2021-06-21,ACTUAL,2023-06-12,2023-06-29,ACTUAL,,,,2023-06-12,2023-06-29,ACTUAL,2021-10-19,ACTUAL,2021-10-19,2023-06,2023-06-30,2022-09-05,ACTUAL,2022-09-05,2022-07-28,ACTUAL,2022-07-28,,INTERVENTIONAL,,"The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study.",MP1032 Treatment in Patients With Moderate to Severe COVID-19,"A Randomized, Double-blind, Placebo-controlled, Multicenter, Proof-of-concept, Phase IIA Study of MP1032 Plus Standard of Care vs Standard of Care in the Treatment of Hospitalized Participants With Moderate to Severe COVID-19",COMPLETED,,PHASE2,132.0,ACTUAL,MetrioPharm AG,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,INDUSTRY,,,,,,,2022,1.0
NCT03827850,,2019-01-22,,,2023-06-07,2019-01-31,2019-02-04,ACTUAL,,,,,,,2023-06-07,2023-06-09,ACTUAL,2019-03-25,ACTUAL,2019-03-25,2023-06,2023-06-30,2022-10-14,ACTUAL,2022-10-14,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,FIND,,FGFR Inhibitor in FGFR Dysregulated Cancer,A Phase II Trial to Evaluate Efficacy and Safety of Erdafitinib in Patients With Advanced Non Small Cell Lung Carcinoma (NSCLC) Harboring Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations After Relapse of Standard Therapy.,TERMINATED,,PHASE2,22.0,ACTUAL,Lung Cancer Group Cologne,,3.0,,"Study-related difficulties faced with patient enrolment, no safety-related reasons",f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,OTHER,,,,,,,2022,0.0
NCT02037529,,2014-01-14,2023-06-07,,2024-07-24,2014-01-14,2014-01-16,ESTIMATED,2023-08-15,2023-09-06,ACTUAL,,,,2024-07-24,2024-08-20,ACTUAL,2014-01-17,ACTUAL,2014-01-17,2023-08,2023-08-31,2024-10-31,ESTIMATED,2024-10-31,2021-02-11,ACTUAL,2021-02-11,,INTERVENTIONAL,,All enrolled patients,Eribulin Mesylate or Paclitaxel as First- or Second-Line Therapy in Treating Patients With Recurrent Stage IIIC-IV Breast Cancer,A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer,SUSPENDED,,PHASE3,201.0,ACTUAL,Academic and Community Cancer Research United,,2.0,,Total enrollment number is being lowered,f,,,,t,t,f,,,f,,,,,,,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,OTHER,,,,,,,2024,0.0
NCT05705167,,2022-12-21,,,2024-07-18,2023-01-27,2023-01-30,ACTUAL,,,,,,,2024-07-18,2024-07-19,ACTUAL,2023-04-19,ACTUAL,2023-04-19,2024-04,2024-04-30,2024-04-19,ACTUAL,2024-04-19,2024-03-19,ACTUAL,2024-03-19,,INTERVENTIONAL,NEREIDA,,Plitidepsin Versus Control in Immunocompromised Adult Participants With Symptomatic COVID-19 Requiring Hospital Care,"A Multicentre, Open Label, Randomised, Controlled, Basket, Pragmatic, Phase II, Clinical and Translational Study to Determine the Efficacy and Safety of Plitidepsin Versus Control in Immunocompromised Adult Patients With Symptomatic COVID-19 Requiring Hospital Care",TERMINATED,,PHASE2,37.0,ACTUAL,PharmaMar,,2.0,,Significant difficulties in the recruitment of patients,f,,,,t,f,f,,,,,,,,,,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,INDUSTRY,,,,,,,2024,0.0
NCT02104817,,2014-04-02,2021-05-25,,2021-08-16,2014-04-02,2014-04-04,ESTIMATED,2021-07-08,2021-07-28,ACTUAL,,,,2021-08-16,2021-08-17,ACTUAL,2014-10-30,ACTUAL,2014-10-30,2021-08,2021-08-31,2020-05-27,ACTUAL,2020-05-27,2020-05-27,ACTUAL,2020-05-27,,INTERVENTIONAL,STRENGTH,,Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia,A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH),COMPLETED,,PHASE3,13078.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,,,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,INDUSTRY,,,,,,,2020,1.0
NCT03599622,,2018-07-11,2024-05-30,2023-09-08,2024-06-28,2018-07-17,2018-07-26,ACTUAL,2024-06-28,2024-07-03,ACTUAL,,2024-07-03,ACTUAL,2024-06-28,2024-07-03,ACTUAL,2018-07-16,ACTUAL,2018-07-16,2024-06,2024-06-30,2023-10-23,ACTUAL,2023-10-23,2022-12-12,ACTUAL,2022-12-12,,INTERVENTIONAL,,,An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's Disease",TERMINATED,,PHASE2,239.0,ACTUAL,Bristol-Myers Squibb,Trial terminated because of lack of efficacy in the short term acute phase.,3.0,,Trial terminated because of lack of efficacy in the short term acute phase,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,INDUSTRY,,,,,,,2023,0.0
NCT03396874,,2018-01-04,2023-08-05,,2023-10-10,2018-01-04,2018-01-11,ACTUAL,2023-10-10,2023-11-03,ACTUAL,,,,2023-10-10,2023-11-03,ACTUAL,2018-02-09,ACTUAL,2018-02-09,2023-10,2023-10-31,2022-08-09,ACTUAL,2022-08-09,2022-08-09,ACTUAL,2022-08-09,,INTERVENTIONAL,,,Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence,Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence,COMPLETED,,PHASE2,1435.0,ACTUAL,University of Michigan,"For Outcome Measure 5, a quality check was performed of the results by analyzing electronic medical records. The analysis showed the questionnaire responses about treatment plans collected post-scan did not align with the actual treatments listed in the medical records.",1.0,,,f,,,,t,t,f,,,,,,Available as requested. Data will be archived indefinitely for research purposes.,Individuals seeking use of these data should contact the study chair.,,YES,Codified data will be archived and stored in an imaging repository with limited metadata for analysis. Individuals seeking use of these data should contact the study chair. A data sharing contract for a HIPAA limited dataset will need to be executed prior to data sharing.,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,OTHER,,,,,,,2022,1.0
NCT04322396,,2020-03-23,2021-06-15,,2021-06-28,2020-03-24,2020-03-26,ACTUAL,2021-06-24,2021-06-28,ACTUAL,,,,2021-06-28,2021-06-29,ACTUAL,2020-04-06,ACTUAL,2020-04-06,2021-06,2021-06-30,2021-02-02,ACTUAL,2021-02-02,2021-02-02,ACTUAL,2021-02-02,,INTERVENTIONAL,ProPAC-COVID,,Proactive Protection With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID-19,"Proactive Protection With Azithromycin and Hydroxychloroquine in Hospitalized Patients With COVID: A Randomized, Placebo-controlled Double-blinded Trial Evaluating Treatment With Azithromycin and Hydroxychloroquine to Patients With COVID-19",TERMINATED,,PHASE2,117.0,ACTUAL,"Chronic Obstructive Pulmonary Disease Trial Network, Denmark",Early termination based on recommendations from the DSMB leading to small numbers of subjects analyzed.,2.0,,Recommended by the DSMB,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,OTHER,,,,,,,2021,0.0
NCT03832738,,2019-02-05,2021-07-21,2021-03-03,2021-08-18,2019-02-05,2019-02-06,ACTUAL,2021-07-21,2021-08-16,ACTUAL,2021-03-04,2021-03-08,ACTUAL,2021-08-18,2021-08-20,ACTUAL,2019-01-17,ACTUAL,2019-01-17,2021-08,2021-08-31,2020-03-13,ACTUAL,2020-03-13,2020-03-13,ACTUAL,2020-03-13,,INTERVENTIONAL,IMPACT-PS,Baseline characteristics results are reported for the Intent-to-Treat (ITT) population: 152 randomized subjects,Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis,"A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of JTE-451 Administered for 16 Weeks in Subjects With Moderate to Severe Plaque Psoriasis (IMPACT-PS)",COMPLETED,,PHASE2,152.0,ACTUAL,Akros Pharma Inc.,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,INDUSTRY,,,,,,,2020,1.0
NCT02825576,,2016-06-21,,,2023-03-27,2016-07-04,2016-07-07,ESTIMATED,,,,,,,2023-03-27,2023-03-29,ACTUAL,2018-12-03,ACTUAL,2018-12-03,2023-03,2023-03-31,2021-01-01,ACTUAL,2021-01-01,2020-04-01,ACTUAL,2020-04-01,,INTERVENTIONAL,P-PERSON,,Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine,Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine,TERMINATED,,PHASE4,30.0,ACTUAL,Northern Sydney Anaesthesia Research Institute,,2.0,,Lack of Study Personnel,f,,,,t,f,f,,,,,,,,,YES,,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,OTHER,,,,,,,2021,0.0
NCT03308565,,2017-10-09,,,2022-08-25,2017-10-09,2017-10-12,ACTUAL,,,,,,,2022-08-25,2022-08-30,ACTUAL,2017-12-05,ACTUAL,2017-12-05,2022-08,2022-08-31,2021-10-11,ACTUAL,2021-10-11,2019-10-22,ACTUAL,2019-10-22,,INTERVENTIONAL,CELLTOP,,Adipose Stem Cells for Traumatic Spinal Cord Injury,Phase I Clinical Trial of Autologous Adipose Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury,COMPLETED,,PHASE1,10.0,ACTUAL,Mayo Clinic,,1.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,OTHER,,,,,,,2021,1.0
NCT04537806,,2020-09-01,2022-07-01,,2022-08-17,2020-09-01,2020-09-03,ACTUAL,2022-07-01,2022-07-27,ACTUAL,,,,2022-08-17,2022-08-19,ACTUAL,2020-12-18,ACTUAL,2020-12-18,2022-08,2022-08-31,2021-07-01,ACTUAL,2021-07-01,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,,FAS included all randomized participants who initiated IP (brexanolone or placebo).,A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19),A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19,TERMINATED,,PHASE3,29.0,ACTUAL,Sage Therapeutics,The study was terminated early due to sponsor's decision and there were no safety concerns.,2.0,,Internal company decision,f,,,,t,t,f,,,,,,,,,NO,Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,INDUSTRY,,,,,,,2021,0.0
NCT05709821,,2023-01-06,,,2024-04-22,2023-01-24,2023-02-02,ACTUAL,,,,,,,2024-04-22,2024-04-24,ACTUAL,2023-11-15,ACTUAL,2023-11-15,2024-04,2024-04-30,2024-04-22,ACTUAL,2024-04-22,2024-04-22,ACTUAL,2024-04-22,,INTERVENTIONAL,,,IMM60 and Pembrolizumab in Melanoma and NSCLC,IMPORT-201: A Phase 1 First-in-Human Dose Finding/Randomized Phase 2 Study of IMM60 and Pembrolizumab for Advanced Melanoma and Metastatic NSCLC,TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,Portage Biotech,,6.0,,Prioritization of other pipeline assets. No safety or efficacy issues were observed.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,INDUSTRY,,,,,,,2024,0.0
NCT03592641,,2018-07-17,2023-07-20,,2023-09-22,2018-07-17,2018-07-19,ACTUAL,2023-07-20,2023-08-08,ACTUAL,,,,2023-09-22,2023-10-17,ACTUAL,2019-07-25,ACTUAL,2019-07-25,2023-09,2023-09-30,2021-12-30,ACTUAL,2021-12-30,2021-07-31,ACTUAL,2021-07-31,,INTERVENTIONAL,,,Savolitinib in Treating Patients With MET Amplified Metastatic or Unresectable Colorectal Cancer,A Phase 2 Study of Savolitinib in Subjects With MET Amplified Metastatic Colorectal Cancer,TERMINATED,,PHASE2,5.0,ACTUAL,National Cancer Institute (NCI),,1.0,,Inadequate accrual rate,f,,,,t,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page",2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,NIH,,,,,,,2021,0.0
NCT04991350,,2021-07-24,,,2023-02-15,2021-08-03,2021-08-05,ACTUAL,,,,,,,2023-02-15,2023-02-16,ACTUAL,2021-11-26,ACTUAL,2021-11-26,2023-02,2023-02-28,2022-11-01,ACTUAL,2022-11-01,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,REBEL,,Effect of Ranibizumab Versus Bevacizumab on the Macular Perfusion in Diabetic Macular Edema,Comparison of the Effect of Ranibizumab Versus Bevacizumab on the Macular Perfusion in Diabetic Macular Edema Using OCTA,TERMINATED,,PHASE4,5.0,ACTUAL,Cairo University,,2.0,,Insufficient recruitment,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,OTHER,,,,,,,2022,0.0
NCT03919045,,2019-04-08,,,2022-03-17,2019-04-16,2019-04-18,ACTUAL,,,,,,,2022-03-17,2022-03-31,ACTUAL,2019-06-17,ACTUAL,2019-06-17,2022-03,2022-03-31,2021-05-21,ACTUAL,2021-05-21,2021-05-21,ACTUAL,2021-05-21,,INTERVENTIONAL,,,Saline Injections for Prophylactic Treatment of Chronic Migraine,Saline Injections for Prophylactic Treatment of Chronic Migraine - a Randomized Controlled Study,TERMINATED,,PHASE4,10.0,ACTUAL,Göteborg University,,2.0,,Due to Covid-19 the rehabilitation unit where the trial was conducted were closed and the trial active clinician had to work at the hospital intensive care.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,OTHER,,,,,,,2021,0.0
NCT04688164,,2020-12-07,2024-02-16,,2024-08-02,2020-12-23,2020-12-29,ACTUAL,2024-03-25,2024-03-26,ACTUAL,,,,2024-08-02,2024-08-27,ACTUAL,2021-01-08,ACTUAL,2021-01-08,2024-08,2024-08-31,2022-11-10,ACTUAL,2022-11-10,2022-11-01,ACTUAL,2022-11-01,,INTERVENTIONAL,Reliance I,,A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD),"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment of Major Depressive Disorder (The RELIANCE-I Study)",COMPLETED,,PHASE3,227.0,ACTUAL,"Relmada Therapeutics, Inc.",,2.0,,,t,,,,t,t,f,,,,,,,,,,,2024-10-15 11:49:23.785341,2024-10-15 11:49:23.785341,INDUSTRY,,NCT06009003,TEMPORARILY_NOT_AVAILABLE,,,,2022,0.0
NCT05554679,,2020-03-20,,,2024-02-10,2022-09-22,2022-09-26,ACTUAL,,,,,,,2024-02-10,2024-02-13,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2024-02,2024-02-29,2023-07-11,ACTUAL,2023-07-11,2022-12-30,ACTUAL,2022-12-30,,INTERVENTIONAL,,,Maternal and Fetal Outcome With Metformin Therapy for Obese Pregnant Women .,Maternal and Fetal Outcome With Metformin Therapy for Obese Pregnant Women a Randomized Control Trial.,TERMINATED,,PHASE4,178.0,ACTUAL,Assiut University,,2.0,,financial issues,f,,,,f,f,f,,,f,,,,,,,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,OTHER,,,,,,,2023,0.0
NCT05042362,,2021-08-26,,2024-06-25,2024-06-26,2021-09-09,2021-09-13,ACTUAL,,,,,2023-12-14,ACTUAL,2024-06-26,2024-06-27,ACTUAL,2021-08-27,ACTUAL,2021-08-27,2024-06,2024-06-30,2023-11-27,ACTUAL,2023-11-27,2023-07-25,ACTUAL,2023-07-25,,INTERVENTIONAL,OASIS-1,,A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause,"A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 26 Weeks in Postmenopausal Women",COMPLETED,,PHASE3,396.0,ACTUAL,Bayer,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,INDUSTRY,,,,,,,2023,1.0
NCT01815580,,2013-03-15,2022-08-12,,2022-09-16,2013-03-20,2013-03-21,ESTIMATED,2022-09-16,2022-09-29,ACTUAL,,,,2022-09-16,2022-09-29,ACTUAL,2013-07,ACTUAL,2013-07-31,2022-09,2022-09-30,2021-06-30,ACTUAL,2021-06-30,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,SABES?,5 participants from the Immediate arm and 4 participants from the Deferred arm were excluded from the analyses because by the time they were enrolled they could no longer be considered Acute or Recent HIV infection.,HIV Test and Treat to Prevent HIV Transmission Among MSM and Transgender Women,"HIV Testing and Treatment to Prevent Onward HIV Transmission Among MSM and Transgender Women in Lima, Peru",COMPLETED,,PHASE4,225.0,ACTUAL,Fred Hutchinson Cancer Center,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,OTHER,,,,,,,2021,1.0
NCT05227209,,2022-01-27,,,2023-12-01,2022-01-27,2022-02-07,ACTUAL,,,,,,,2023-12-01,2023-12-08,ACTUAL,2022-03-17,ACTUAL,2022-03-17,2023-12,2023-12-31,2023-11-17,ACTUAL,2023-11-17,2023-11-17,ACTUAL,2023-11-17,,INTERVENTIONAL,,,A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).,"A 12-Month Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Effectiveness of SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)",TERMINATED,,PHASE3,64.0,ACTUAL,"Sumitomo Pharma America, Inc.",,1.0,,Company decided not to move forward with further accrual.,f,,,,t,t,f,,,,,,IPD will be made available upon request within 12 months of posting the study results on ct.gov.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://vivli.org,YES,IPD for this study may be made available upon request via theVivli Center for Global Clinical Reserach Data site,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,INDUSTRY,,,,,,,2023,0.0
NCT05254613,,2022-02-15,2023-07-24,,2024-03-20,2022-02-15,2022-02-24,ACTUAL,2024-03-20,2024-03-22,ACTUAL,,,,2024-03-20,2024-03-22,ACTUAL,2019-11-12,ACTUAL,2019-11-12,2024-03,2024-03-31,2021-01-22,ACTUAL,2021-01-22,2021-01-22,ACTUAL,2021-01-22,,INTERVENTIONAL,,The safety population consisted of all participants who received at least 1 dose of study drug.,A Study of Single and Multiple SC Doses of ALXN1830 in Healthy Adult Participants,"A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of Subcutaneous ALXN1830 in Healthy Participants",TERMINATED,,PHASE1,12.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",The study was terminated early due to a lack of participant availability caused by COVID-19 pandemic after completion of the ALXN1830 750 mg dose group and partial enrollment of the ALXN1830 1250 mg dose group.,7.0,,The justification of the early termination of the trial: the study is early terminated due to the Coronavirus 2019 epidemic.,f,,,,f,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,INDUSTRY,,,,,,,2021,0.0
NCT03653026,,2018-08-28,2021-10-29,,2022-02-17,2018-08-28,2018-08-31,ACTUAL,2021-10-29,2021-11-26,ACTUAL,,,,2022-02-17,2022-03-02,ACTUAL,2018-12-06,ACTUAL,2018-12-06,2022-02,2022-02-28,2021-01-14,ACTUAL,2021-01-14,2021-01-14,ACTUAL,2021-01-14,,INTERVENTIONAL,U-Accomplish,,A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis",COMPLETED,,PHASE3,522.0,ACTUAL,AbbVie,,2.0,,,f,,,,t,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,INDUSTRY,,,,,,,2021,1.0
NCT04653142,,2020-11-27,,,2022-05-09,2020-11-27,2020-12-04,ACTUAL,,,,,,,2022-05-09,2022-05-10,ACTUAL,2020-12-15,ACTUAL,2020-12-15,2022-05,2022-05-31,2022-04-20,ACTUAL,2022-04-20,2022-04-20,ACTUAL,2022-04-20,,INTERVENTIONAL,,,A Study to Test Different Doses of BI 765063 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer (Solid Tumors),"An Open Label, Phase I Study of BI 765063 Monotherapy, and Its Combination Therapy With BI 754091, to Characterize Safety, Pharmacokinetics, and Pharmacodynamics in Japanese Patients With Advanced Solid Tumors",COMPLETED,,PHASE1,18.0,ACTUAL,Boehringer Ingelheim,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,INDUSTRY,,,,,,,2022,0.0
NCT04786964,,2021-03-04,,,2024-08-19,2021-03-04,2021-03-08,ACTUAL,,,,,,,2024-08-19,2024-08-20,ACTUAL,2021-12-08,ACTUAL,2021-12-08,2024-08,2024-08-31,2023-12-30,ACTUAL,2023-12-30,2023-12-30,ACTUAL,2023-12-30,,INTERVENTIONAL,CONTERNO,,Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab (CK-301) in First Line Metastatic Non-squamous Non-Small Cell Lung Cancer,"A Randomized, Open-Label, Phase 3 Study of Cosibelimab (CK-301) in Combination With Platinum+Pemetrexed Chemotherapy in Subjects With First-Line Metastatic Non-squamous Non-Small Cell Lung Cancer",TERMINATED,,PHASE3,25.0,ACTUAL,"Checkpoint Therapeutics, Inc.",,2.0,,Regional political conflict,f,,,,t,t,f,,,t,,,,,,,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,INDUSTRY,,,,,,,2023,0.0
NCT06377722,,2024-04-17,,,2024-04-24,2024-04-17,2024-04-22,ACTUAL,,,,,,,2024-04-24,2024-04-26,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2024-04,2024-04-30,2022-08-09,ACTUAL,2022-08-09,2022-08-09,ACTUAL,2022-08-09,,INTERVENTIONAL,,,Cabozantinib Treatment Prior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer,Phase II Study for the Evaluation of Neoadjuvant Treatment With Cabozantinib Pior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer,TERMINATED,,PHASE2,18.0,ACTUAL,Fundacion Oncosur,,1.0,,"The achieved number of samples has been smaller than the planned 50 thus, a mainly descriptive final result analysis was conducted, as presented herein.",f,,,,,f,f,,,,,,,,,,,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,NETWORK,,,,,,,2022,0.0
NCT02284737,,2014-10-28,,,2024-02-16,2014-11-04,2014-11-06,ESTIMATED,,,,,,,2024-02-16,2024-02-20,ACTUAL,2014-11-28,ACTUAL,2014-11-28,2024-02,2024-02-29,2021-07-30,ACTUAL,2021-07-30,2021-07-30,ACTUAL,2021-07-30,,INTERVENTIONAL,PADN-PAH,,A Study to Investigate the Efficacy of PADN to Improved Functional Capacity and Hemodynamics in Patients With PAH,"A Prospective, Multi-center, Randomized Control Trial to Investigate the Efficacy of Pulmonary Artery Denervation to Improved Functional Capacity and Hemodynamics in Patients With Pulmonary Artery Hypertension",TERMINATED,,PHASE4,100.0,ACTUAL,"Nanjing First Hospital, Nanjing Medical University",,2.0,,Lack of subjects.,f,,,,t,f,f,,,t,,,,,,NO,,2024-10-15 11:55:28.299041,2024-10-15 11:55:28.299041,OTHER,,,,,,,2021,0.0
NCT04150562,,2019-11-01,2022-03-31,,2022-04-27,2019-11-01,2019-11-04,ACTUAL,2022-04-27,2022-05-17,ACTUAL,,,,2022-04-27,2022-05-17,ACTUAL,2020-05-26,ACTUAL,2020-05-26,2022-04,2022-04-30,2021-09-16,ACTUAL,2021-09-16,2021-07-23,ACTUAL,2021-07-23,,INTERVENTIONAL,,,Avelumab (Bavencio) With IL-15 in Subjects With Clear-Cell Renal Carcinoma,Phase II Trial of Avelumab (Bavencio) With IL-15 in Subjects With Clear-Cell Renal Carcinoma,TERMINATED,,PHASE2,2.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,This study was terminated early due to manufacturer withdrawal of support (study medication) due to lack of enrollment.,f,,,,f,t,f,,,,,,Clinical data will be available during the study and indefinitely.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).,,YES,All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,NIH,,,,,,,2021,0.0
NCT05256810,,2022-02-16,,,2024-03-28,2022-02-16,2022-02-25,ACTUAL,,,,,,,2024-03-28,2024-03-29,ACTUAL,2022-02-25,ACTUAL,2022-02-25,2024-03,2024-03-31,2023-01-25,ACTUAL,2023-01-25,2023-01-25,ACTUAL,2023-01-25,,INTERVENTIONAL,,,A Study to Evaluate ALN-XDH in Healthy Subjects and Patients With Gout,"A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Dose Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALN-XDH in Healthy Adult Subjects and Adult Patients With Gout",TERMINATED,,PHASE1/PHASE2,44.0,ACTUAL,Alnylam Pharmaceuticals,,7.0,,The Sponsor elected not to continue with the study,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,INDUSTRY,,,,,,,2023,0.0
NCT04486313,,2020-07-23,2024-02-07,2022-02-10,2024-03-28,2020-07-23,2020-07-24,ACTUAL,2024-03-28,2024-03-29,ACTUAL,,2024-03-29,ACTUAL,2024-03-28,2024-03-29,ACTUAL,2020-08-13,ACTUAL,2020-08-13,2024-03,2024-03-31,2021-02-08,ACTUAL,2021-02-08,2021-02-08,ACTUAL,2021-02-08,,INTERVENTIONAL,,,Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19,"Phase 3, Randomized, Double-Blind, Placebo-Controlled, Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19",COMPLETED,,PHASE3,935.0,ACTUAL,Romark Laboratories L.C.,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:41:35.906716,2024-10-15 22:41:35.906716,INDUSTRY,,,,,,,2021,1.0
NCT05414864,,2022-05-05,,,2022-12-27,2022-06-07,2022-06-10,ACTUAL,,,,,,,2022-12-27,2022-12-29,ACTUAL,2022-05-01,ACTUAL,2022-05-01,2022-07,2022-07-31,2022-09-30,ACTUAL,2022-09-30,2022-07-31,ACTUAL,2022-07-31,,INTERVENTIONAL,Print-HAS,,Insomnia Prevalence and Treatment Impact on Systemic Hypertension,Insomnia Prevalence and Treatment Impact on Systemic Hypertension,TERMINATED,,PHASE4,5.0,ACTUAL,University of Sao Paulo,,2.0,,Takeda suspended financial support. The first phase (observational study) is ongoing.,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,OTHER,,,,,,,2022,0.0
NCT03965624,,2019-05-24,,,2019-10-25,2019-05-24,2019-05-29,ACTUAL,,,,,,,2019-10-25,2019-10-28,ACTUAL,2019-09-01,ESTIMATED,2019-09-01,2018-12,2018-12-31,2023-09-01,ESTIMATED,2023-09-01,2023-03-01,ESTIMATED,2023-03-01,,INTERVENTIONAL,Ixa-Cyto,,Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia,A Prospective Open-label Trial to Assess the Efficacy and Safety of Ixazomib and Dexamethasone in Patients With Refractory Autoimmune Cytopenia,WITHDRAWN,,PHASE2,0.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,1.0,,Decision of sponsor: impossibility of contract with Takeda,f,,,,t,f,f,,,,,,,,,NO,"DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION",2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,OTHER,,,,,,,2023,0.0
NCT03575598,,2018-06-11,,,2023-07-24,2018-06-28,2018-07-02,ACTUAL,,,,,,,2023-07-24,2023-07-27,ACTUAL,2018-08-30,ACTUAL,2018-08-30,2023-07,2023-07-31,2020-02-18,ACTUAL,2020-02-18,2020-02-18,ACTUAL,2020-02-18,,INTERVENTIONAL,SNOW,,Sitravatinib (MGCD516) and Nivolumab in Oral Cavity Cancer Window Opportunity Study,Sitravatinib (MGCD516) and Nivolumab in Oral Cavity Cancer Window Opportunity Study (SNOW),COMPLETED,,EARLY_PHASE1,10.0,ACTUAL,"University Health Network, Toronto",,1.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,OTHER,,,,,,,2020,1.0
NCT01143545,,2010-06-11,,,2020-03-02,2010-06-11,2010-06-14,ESTIMATED,,,,,,,2020-03-02,2020-03-03,ACTUAL,2010-12-07,ACTUAL,2010-12-07,2020-03,2020-03-31,2020-02-26,ACTUAL,2020-02-26,2015-02-09,ACTUAL,2015-02-09,,INTERVENTIONAL,,,"Pilot Study of Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thymic Neoplasms, and Malignant Pleural Mesotheliomas","Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib as Adjuvant Therapy for Lung and Esophageal Cancers, Thymic Neoplasms, Thoracic Sarcomas, and Malignant Pleural Mesotheliomas",TERMINATED,,PHASE1,10.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,Closed accrual due to unpromising results and the opening of study 14C0053 targeting the same population.,f,,,,,t,f,,,,,,,,,,,2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,NIH,,,,,,,2020,0.0
NCT02892201,,2016-08-19,2023-08-23,,2023-12-07,2016-09-01,2016-09-08,ESTIMATED,2023-10-26,2023-11-18,ACTUAL,,,,2023-12-07,2023-12-28,ACTUAL,2016-09-08,ACTUAL,2016-09-08,2023-12,2023-12-31,2020-03,ACTUAL,2020-03-31,2020-02,ACTUAL,2020-02-29,,INTERVENTIONAL,,,Pembrolizumab in HNSCC With Residual Disease After Radiation,A Phase II Study of Pembrolizumab for Patients With Head and Neck Squamous Cell Carcinoma With Residual Disease Following Definitive Chemoradiation,TERMINATED,,PHASE2,9.0,ACTUAL,Yale University,,1.0,,Low enrollment,f,,,,t,,,,,,,,,,,NO,,2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,OTHER,,,,,,,2020,0.0
NCT02740270,,2016-04-05,,,2021-02-18,2016-04-11,2016-04-15,ESTIMATED,,,,,,,2021-02-18,2021-02-21,ACTUAL,2016-07-22,ACTUAL,2016-07-22,2021-02,2021-02-28,2020-03-03,ACTUAL,2020-03-03,2020-03-03,ACTUAL,2020-03-03,,INTERVENTIONAL,,,Phase I/Ib Study of GWN323 Alone and in Combination With PDR001 in Patients With Advanced Malignancies and Lymphomas,"A Phase I/Ib Open-label, Multi-center, Dose Escalation Study of GWN323 (Anti-GITR) as a Single Agent and in Combination With PDR001 (Anti-PD-1) in Patients With Advanced Solid Tumors and Lymphomas",COMPLETED,,PHASE1,92.0,ACTUAL,Novartis,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,INDUSTRY,,,,,,,2020,1.0
NCT03544229,,2018-05-21,2022-06-13,,2022-10-24,2018-05-21,2018-06-01,ACTUAL,2022-10-24,2022-11-16,ACTUAL,,,,2022-10-24,2022-11-16,ACTUAL,2018-10-14,ACTUAL,2018-10-14,2022-10,2022-10-31,2021-07-15,ACTUAL,2021-07-15,2021-06-14,ACTUAL,2021-06-14,,INTERVENTIONAL,,Randomized Set included all participants who were randomized.,A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants With Symptomatic Idiopathic or Diabetic Gastroparesis,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Study to Evaluate the Efficacy and Safety of Twice-Daily Oral Administration of a Peripherally Acting Dopamine Receptor D2/D3 Antagonist, TAK-906 for the Treatment of Adult Subjects With Symptomatic Idiopathic or Diabetic Gastroparesis",COMPLETED,,PHASE2,242.0,ACTUAL,Takeda,,4.0,,,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,INDUSTRY,,,,,,,2021,1.0
NCT04059406,,2019-08-14,,2024-02-26,2024-02-29,2019-08-14,2019-08-16,ACTUAL,,,,,2024-03-04,ACTUAL,2024-02-29,2024-03-04,ACTUAL,2020-09-24,ACTUAL,2020-09-24,2024-02,2024-02-29,2023-03-28,ACTUAL,2023-03-28,2023-03-28,ACTUAL,2023-03-28,,INTERVENTIONAL,,,"Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sapablursen (Formerly ISIS 702843, IONIS-TMPRSS6-LRx)","A Phase 2a, Randomized, Open-Label Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ISIS 702843 Administered Subcutaneously to Patients With Non-Transfusion Dependent β-Thalassemia Intermedia",TERMINATED,,PHASE2,29.0,ACTUAL,"Ionis Pharmaceuticals, Inc.",,3.0,,"Favorable safety and tolerability were seen, but efficacy results in the mid-stage study did not meet Ionis' minimum target product profile to justify further development.",f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,INDUSTRY,,,,,,,2023,0.0
NCT05387577,,2022-04-16,,,2022-12-19,2022-05-19,2022-05-24,ACTUAL,,,,,,,2022-12-19,2022-12-21,ACTUAL,2021-12-07,ACTUAL,2021-12-07,2022-12,2022-12-31,2022-11-23,ACTUAL,2022-11-23,2022-11-23,ACTUAL,2022-11-23,,INTERVENTIONAL,,,Coagulation and Fibrinolysis of Estradiol in Transwomen,Coagulation Activation and Fibrinolysis With Sublingual Versus Oral Versus Transdermal Estradiol in Transgender Women,TERMINATED,,EARLY_PHASE1,6.0,ACTUAL,Medical College of Wisconsin,,3.0,,per MCW IRB,f,,,,f,t,f,,,f,,,starting 3 months after publication,IPD will be shared if PI is directly contacted and asked for the above information.,,YES,All individual participant data that underlie results in a publication.,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,OTHER,,,,,,,2022,0.0
NCT04387071,,2020-05-09,,,2023-03-17,2020-05-09,2020-05-13,ACTUAL,,,,,,,2023-03-17,2023-03-22,ACTUAL,2021-04-29,ACTUAL,2021-04-29,2023-03,2023-03-31,2022-12-19,ACTUAL,2022-12-19,2022-12-19,ACTUAL,2022-12-19,,INTERVENTIONAL,,,CMP-001 and INCAGN01949 for Patients With Stage IV Pancreatic Cancer and Other Cancers Except Melanoma,The Seena Magowitz Phase IB/II Trial of CMP-001 (a TLR9 Agonist) in Combination With INCAGN01949 (an Activating Anti-OX40 Antibody) for In Situ Intratumoral Injection for Patients With Stage IV Pancreatic and Other Cancers Except Melanoma,TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,University of Southern California,,1.0,,Study drug no longer available,,,,,t,t,f,,,f,,,,,,,,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,OTHER,,,,,,,2022,0.0
NCT01118026,,2010-05-05,2021-09-29,,2021-11-05,2010-05-05,2010-05-06,ESTIMATED,2021-11-05,2021-12-01,ACTUAL,,,,2021-11-05,2021-12-01,ACTUAL,2010-09,ACTUAL,2010-09-30,2021-11,2021-11-30,2021-09-29,ACTUAL,2021-09-29,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,,,Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma,Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and Stage II Classical Hodgkin Lymphoma (HL),COMPLETED,,PHASE2,101.0,ACTUAL,Alliance for Clinical Trials in Oncology,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,OTHER,,,,,,,2021,1.0
NCT04588688,,2020-10-09,2022-12-21,,2023-05-19,2020-10-09,2020-10-19,ACTUAL,2023-05-19,2023-06-12,ACTUAL,,,,2023-05-19,2023-06-12,ACTUAL,2021-05-05,ACTUAL,2021-05-05,2023-05,2023-05-31,2021-08-01,ACTUAL,2021-08-01,2021-08-01,ACTUAL,2021-08-01,,INTERVENTIONAL,,,Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency,Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency,TERMINATED,,PHASE2,3.0,ACTUAL,University of Michigan,,1.0,,low recruitment,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,OTHER,,,,,,,2021,0.0
NCT01369212,,2011-06-06,2022-05-13,,2023-04-25,2011-06-07,2011-06-08,ESTIMATED,2022-09-14,2022-10-12,ACTUAL,,,,2023-04-25,2023-04-28,ACTUAL,2012-11,,2012-11-30,2023-04,2023-04-30,2021-03-08,ACTUAL,2021-03-08,2021-03-08,ACTUAL,2021-03-08,,INTERVENTIONAL,HBRN,,Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B,Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in HBeAg-positive and HBeAg-negative Chronic Hepatitis B,COMPLETED,,PHASE3,201.0,ACTUAL,National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),,2.0,,,f,,,,t,t,f,,,,,,,,https://repository.niddk.nih.gov/home/,YES,Data will be available at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository https://repository.niddk.nih.gov/home/,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,NIH,,,,,,,2021,1.0
NCT02997202,,2016-12-01,2024-05-06,2024-02-28,2024-08-16,2016-12-15,2016-12-19,ESTIMATED,2024-08-16,2024-09-19,ACTUAL,,2024-09-19,ACTUAL,2024-08-16,2024-09-19,ACTUAL,2017-08-16,ACTUAL,2017-08-16,2024-08,2024-08-31,2023-05-09,ACTUAL,2023-05-09,2023-01-07,ACTUAL,2023-01-07,,INTERVENTIONAL,,Intention-to-Treat (ITT) population: All randomized participants were included in this population,A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML),"A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/ITD AML",COMPLETED,,PHASE3,356.0,ACTUAL,Astellas Pharma Inc,,2.0,,,t,,,,t,t,f,,,,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",http://www.clinicalstudydatarequest.com,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,INDUSTRY,,NCT03070093,APPROVED_FOR_MARKETING,,,,2023,1.0
NCT04653389,,2020-11-28,,,2021-12-21,2020-11-28,2020-12-04,ACTUAL,,,,,,,2021-12-21,2022-01-11,ACTUAL,2020-12-26,ACTUAL,2020-12-26,2021-02,2021-02-28,2021-12-01,ACTUAL,2021-12-01,2021-10-01,ACTUAL,2021-10-01,,INTERVENTIONAL,,,Perioperative Therapy for Hepatocellular Carcinoma,Perioperative Multidisciplinary Therapy for Technically Resectable Hepatocellular Carcinoma With Vein Thrombosis: An Exploratory Clinical Trail,TERMINATED,,PHASE2,10.0,ACTUAL,Zhejiang University,,1.0,,The treatment efficacy was not satisfactory.,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,OTHER,,,,,,,2021,0.0
NCT02644967,,2015-12-23,2022-02-10,,2022-07-08,2015-12-31,2016-01-01,ESTIMATED,2022-07-08,2022-08-03,ACTUAL,,,,2022-07-08,2022-08-03,ACTUAL,2015-12,ACTUAL,2015-12-31,2022-07,2022-07-31,2021-05,ACTUAL,2021-05-31,2020-02,ACTUAL,2020-02-29,,INTERVENTIONAL,,Includes all participants who received at least 1 dose of study treatment.,A Phase 2 Study to Assess the Safety and Efficacy of IMO-2125 With 8 mg Ipilimumab in Patients With Metastatic Melanoma,A Phase 1/2 Study to Assess the Safety and Efficacy of Intratumoral IMO-2125 in Combination With Ipilimumab or Pembrolizumab in Patients With Metastatic Melanoma (ILLUMINATE-204),COMPLETED,,PHASE2,53.0,ACTUAL,"Idera Pharmaceuticals, Inc.","The analysis populations, as defined in section 6 of the Statistical Analysis Plan, analyzed participants enrolled in the phase 2 study (N=44) and participants rolled in from the phase 1, 8 mg Tilso/Ipi population (N=9).",1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:55:28.299041,2024-10-15 11:55:28.299041,INDUSTRY,,,,,,,2021,1.0
NCT03224585,,2017-07-19,2020-12-17,,2021-02-05,2017-07-19,2017-07-21,ACTUAL,2021-02-05,2021-02-23,ACTUAL,,,,2021-02-05,2021-02-23,ACTUAL,2018-05-11,ACTUAL,2018-05-11,2021-02,2021-02-28,2020-02-01,ACTUAL,2020-02-01,2020-02-01,ACTUAL,2020-02-01,,INTERVENTIONAL,,,Treatment of Acute Pericarditis With Anakinra,Treatment of Acute Pericarditis With Anakinra,TERMINATED,,PHASE2,5.0,ACTUAL,Virginia Commonwealth University,,2.0,,Study was terminated because dramatic benefits seen during the first 24 hours of drug administration combined with COVID restrictions on research activities suggested it was both unethical and unnecessary to complete the planned enrollment,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 08:42:10.038527,2024-10-16 08:42:10.038527,OTHER,,,,,,,2020,0.0
NCT05273658,,2022-02-28,,,2023-09-02,2022-03-09,2022-03-10,ACTUAL,,,,,,,2023-09-02,2023-09-07,ACTUAL,2022-08,ESTIMATED,2022-08-31,2023-09,2023-09-30,2023-06,ESTIMATED,2023-06-30,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,Effects of Cannabis/Alcohol on Driving Performance and Field Sobriety Tests,Effects of Cannabis/Alcohol on Driving Performance and Field Sobriety Tests,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"University of California, San Diego",,5.0,,Termination of funding,f,,,,t,t,f,,,,,,,,,,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,OTHER,,,,,,,2023,0.0
NCT04771143,,2021-02-24,,,2021-06-28,2021-02-24,2021-02-25,ACTUAL,,,,,,,2021-06-28,2021-07-01,ACTUAL,2021-07-21,ESTIMATED,2021-07-21,2021-06,2021-06-30,2022-01-03,ESTIMATED,2022-01-03,2022-01-03,ESTIMATED,2022-01-03,,INTERVENTIONAL,,,"Study to Assess Safety, Tolerability, and Interactions of Cocaine and Oral AFQ056","A Randomized, Participant- and Investigator-blinded, Placebo-controlled, Parallel Group Study to Assess Safety, Tolerability, and Potential Interactions of Oral AFQ056 Given Concurrently With Cocaine",WITHDRAWN,,PHASE1,0.0,ACTUAL,Novartis,,2.0,,study terminated/withdrawn before FPFV (no patients enrolled),f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,INDUSTRY,,,,,,,2022,0.0
NCT05014919,,2021-08-16,2022-10-04,,2022-12-12,2021-08-16,2021-08-20,ACTUAL,2022-12-12,2023-01-05,ACTUAL,,,,2022-12-12,2023-01-05,ACTUAL,2021-08-10,ACTUAL,2021-08-10,2022-12,2022-12-31,2022-04-28,ACTUAL,2022-04-28,2022-03-31,ACTUAL,2022-03-31,,INTERVENTIONAL,,All-patients-enrolled (APES): all participants enrolled to the 12-week open-label treatment period who took at least 1 dose of study drug. Full analysis set (FAS): all participants randomized to the 26-week double-blind treatment period who took at least 1 dose of double-blind study drug.,Vortioxetine to Prevent Return of Symptoms in Children With Depression,"A Double-blind, Randomized, Placebo-controlled, Multicentre, Relapse-prevention Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder",TERMINATED,,PHASE3,35.0,ACTUAL,H. Lundbeck A/S,The study was terminated based on new efficacy data from another study. The main primary and secondary efficacy objectives were not assessed due to termination of the study and the limited number of participants who completed the double-blind period.,3.0,,The study was terminated based on new efficacy data from another study.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,INDUSTRY,,,,,,,2022,0.0
NCT03272217,,2017-09-01,,,2022-12-15,2017-09-01,2017-09-05,ACTUAL,,,,,,,2022-12-15,2022-12-19,ACTUAL,2017-09-13,ACTUAL,2017-09-13,2022-12,2022-12-31,2022-03-17,ACTUAL,2022-03-17,2021-05-27,ACTUAL,2021-05-27,,INTERVENTIONAL,,,Atezolizumab With Bevacizumab in Previously Untreated Metastatic/Unresectable Urothelial Cancer,A Phase II Trial of Atezolizumab and Bevacizumab in Cisplatin-ineligible Patients With Advanced/Unresectable Urothelial Cancer,TERMINATED,,PHASE2,16.0,ACTUAL,Hoosier Cancer Research Network,,1.0,,Funder decision,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,OTHER,,,,,,,2022,0.0
NCT03481959,,2018-03-12,,,2022-04-15,2018-03-22,2018-03-29,ACTUAL,,,,,,,2022-04-15,2022-04-25,ACTUAL,2019-05-07,ACTUAL,2019-05-07,2020-11,2020-11-30,2020-09-01,ACTUAL,2020-09-01,2020-09-01,ACTUAL,2020-09-01,,INTERVENTIONAL,METHACAN,,Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity,Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity,TERMINATED,,PHASE3,3.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,insufficient recrutement in the study,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 11:55:28.299041,2024-10-15 11:55:28.299041,OTHER,,,,,,,2020,0.0
NCT02315066,,2014-12-04,2021-11-10,,2022-02-18,2014-12-09,2014-12-11,ESTIMATED,2022-02-18,2022-04-21,ACTUAL,,,,2022-02-18,2022-04-21,ACTUAL,2015-04-23,ACTUAL,2015-04-23,2022-02,2022-02-28,2020-11-12,ACTUAL,2020-11-12,2020-11-12,ACTUAL,2020-11-12,,INTERVENTIONAL,,The baseline analysis population included all enrolled patients who received at least one full or partial IV infusion of study drug PF-04518600.,Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566,"A PHASE 1, OPEN-LABEL, DOSE ESCALATION STUDY OF PF-04518600 AS A SINGLE AGENT AND IN COMBINATION WITH PF-05082566 IN PATIENTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC CANCERS",COMPLETED,,PHASE1,174.0,ACTUAL,Pfizer,A decision was made by the sponsor to terminate further enrollment to the study on 03 Oct 2018 due to business reasons. The decision to terminate study enrollment was not based on any safety or regulatory concerns.,2.0,,,f,,,,f,,,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 17:49:54.341132,2024-10-16 17:49:54.341132,INDUSTRY,,,,,,,2020,1.0
NCT04507204,,2020-07-24,2023-01-30,,2023-07-07,2020-08-06,2020-08-11,ACTUAL,2023-07-07,2023-07-27,ACTUAL,,,,2023-07-07,2023-07-27,ACTUAL,2020-07-30,ACTUAL,2020-07-30,2023-07,2023-07-31,2022-01-31,ACTUAL,2022-01-31,2021-12-22,ACTUAL,2021-12-22,,INTERVENTIONAL,RE-DAX,,Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD),Real-world Evidence of Duration of Adhansia XR for Treatment of ADHD (RE-DAX): An Open-label Pragmatic Study to Assess the Real-world Effectiveness of Adhansia XR in Treatment of Adult and Adolescent Patients With ADHD in the United States,TERMINATED,,PHASE4,267.0,ACTUAL,Purdue Pharma LP,,2.0,,(due to administrative reasons not related to efficacy or safety.),f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,INDUSTRY,,,,,,,2022,0.0
NCT04232878,,2020-01-10,,,2020-06-18,2020-01-16,2020-01-18,ACTUAL,,,,,,,2020-06-18,2020-06-22,ACTUAL,2019-12-16,ACTUAL,2019-12-16,2020-06,2020-06-30,2020-05-21,ACTUAL,2020-05-21,2020-03-06,ACTUAL,2020-03-06,,INTERVENTIONAL,,,A Single Ascending Dose Trial of CVL-936 in Healthy Subjects,"A Phase 1, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In-Human Trial To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Ascending Doses of CVL-936 In Healthy Subjects",TERMINATED,,PHASE1,10.0,ACTUAL,"Cerevel Therapeutics, LLC",,14.0,,Sufficient data has been obtained to meet current objectives,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,INDUSTRY,,,,,,,2020,0.0
NCT03730662,,2018-11-02,2022-01-21,,2022-01-21,2018-11-02,2018-11-05,ACTUAL,2022-01-21,2022-02-14,ACTUAL,,,,2022-01-21,2022-02-14,ACTUAL,2018-11-20,ACTUAL,2018-11-20,2022-01,2022-01-31,2021-04-22,ACTUAL,2021-04-22,2021-01-22,ACTUAL,2021-01-22,,INTERVENTIONAL,SURPASS-4,All randomized participants.,A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk,Efficacy and Safety of LY3298176 Once Weekly Versus Insulin Glargine in Patients With Type 2 Diabetes and Increased Cardiovascular Risk (SURPASS-4),COMPLETED,,PHASE3,2002.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,INDUSTRY,,,,,,,2021,1.0
NCT02188368,,2014-07-07,,,2023-11-01,2014-07-09,2014-07-11,ESTIMATED,,,,,,,2023-11-01,2023-11-03,ACTUAL,2014-07-07,ACTUAL,2014-07-07,2023-11,2023-11-30,2020-10-23,ACTUAL,2020-10-23,2020-10-23,ACTUAL,2020-10-23,,INTERVENTIONAL,,,Pomalidomide for Lenalidomide for Relapsed or Refractory Multiple Myeloma Patients,A Phase 2 Study of Pomalidomide as a Replacement for Lenalidomide for Multiple Myeloma Patients Relapsed or Refractory to a Lenalidomide-Containing Combination Regimen,TERMINATED,,PHASE2,45.0,ACTUAL,Oncotherapeutics,,3.0,,Lack of enrollment,f,,,,t,,,,,,,,,,,,,2024-10-15 11:55:28.299041,2024-10-15 11:55:28.299041,INDUSTRY,,,,,,,2020,0.0
NCT02907359,,2016-09-08,2023-03-23,2021-03-29,2024-07-31,2016-09-15,2016-09-20,ESTIMATED,2023-04-25,2023-05-18,ACTUAL,2021-03-29,2021-04-01,ACTUAL,2024-07-31,2024-08-27,ACTUAL,2017-01-13,ACTUAL,2017-01-13,2024-07,2024-07-31,2020-11-30,ACTUAL,2020-11-30,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,The Efficacy Analysis Set included all participants randomly assigned to the study treatment.,Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs,"A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) Previously Treated With Hypomethylating Agents",COMPLETED,,PHASE3,417.0,ACTUAL,"Astex Pharmaceuticals, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 11:55:28.299041,2024-10-15 11:55:28.299041,INDUSTRY,,,,,,,2020,1.0
NCT04707534,,2021-01-11,2023-12-04,,2024-03-28,2021-01-12,2021-01-13,ACTUAL,2024-03-28,2024-03-29,ACTUAL,,,,2024-03-28,2024-03-29,ACTUAL,2021-01-21,ACTUAL,2021-01-21,2024-03,2024-03-31,2022-03-04,ACTUAL,2022-03-04,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Comparing the Effects of Different Doses of Dexamethasone to Treat Inpatient COVID-19,Effects of Higher Dose and Lower Dose of Dexamethasone for Hospitalized Patients With COVID-19,COMPLETED,,PHASE4,110.0,ACTUAL,University of Oklahoma,,2.0,,,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 11:55:28.299041,2024-10-15 11:55:28.299041,OTHER,,,,,,,2022,1.0
NCT02696031,,2015-10-13,2020-06-30,,2022-04-04,2016-02-25,2016-03-02,ESTIMATED,2020-08-04,2020-08-07,ACTUAL,,,,2022-04-04,2022-04-29,ACTUAL,2016-04-29,ACTUAL,2016-04-29,2022-04,2022-04-30,2021-03-11,ACTUAL,2021-03-11,2019-07-01,ACTUAL,2019-07-01,,INTERVENTIONAL,PREVENT,,Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis,"A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs",COMPLETED,,PHASE3,555.0,ACTUAL,Novartis,,6.0,,,f,,,,f,t,f,,,,,,,,https://clinicalstudydatarequest.com/Default.aspx,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,INDUSTRY,,,,,,,2021,1.0
NCT04497987,,2020-07-31,2022-01-11,,2022-02-02,2020-07-31,2020-08-04,ACTUAL,2022-02-02,2022-02-04,ACTUAL,,,,2022-02-02,2022-02-04,ACTUAL,2020-08-02,ACTUAL,2020-08-02,2022-02,2022-02-28,2021-05-20,ACTUAL,2021-05-20,2021-01-16,ACTUAL,2021-01-16,,INTERVENTIONAL,BLAZE-2,All randomized participants who received at least one dose of study drug.,A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff,"A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of LY3819253 Alone and in Combination With LY3832479 in Preventing SARS-CoV-2 Infection and COVID-19 in Skilled Nursing and Assisted Living Facility Residents and Staff; a NIAID and Lilly Collaborative Study",COMPLETED,,PHASE3,1180.0,ACTUAL,Eli Lilly and Company,,9.0,,,f,,,,t,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 11:55:28.299041,2024-10-15 11:55:28.299041,INDUSTRY,,,,,,,2021,1.0
NCT03269695,,2017-08-30,2021-10-06,,2021-11-29,2017-08-30,2017-09-01,ACTUAL,2021-11-29,2021-12-28,ACTUAL,,,,2021-11-29,2021-12-28,ACTUAL,2017-12-20,ACTUAL,2017-12-20,2021-11,2021-11-30,2021-01-07,ACTUAL,2021-01-07,2021-01-07,ACTUAL,2021-01-07,,INTERVENTIONAL,,All participants who received at least one dose of randomized treatment were included in the baseline analysis population.,"Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.","A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC)",TERMINATED,,PHASE2,20.0,ACTUAL,Pfizer,"The study was terminated after an interim analysis, due to efficacy being considered unlikely to meet the projected target.",2.0,,The Sponsor changed R\&D strategy and priority.,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,INDUSTRY,,,,,,,2021,0.0
NCT05294263,,2022-02-09,,,2024-08-23,2022-03-14,2022-03-24,ACTUAL,,,,,,,2024-08-23,2024-08-27,ACTUAL,2023-04-17,ACTUAL,2023-04-17,2024-08,2024-08-31,2024-07-17,ACTUAL,2024-07-17,2024-07-17,ACTUAL,2024-07-17,,INTERVENTIONAL,Vet Cat,,Varenicline for the Treatment of Cannabis and Tobacco Use Disorders in Veterans,Varenicline for Comorbid Tobacco and Cannabis Use in Veterans,WITHDRAWN,,PHASE2,0.0,ACTUAL,VA Office of Research and Development,,2.0,,"Despite the numerous approaches below, we have not been successful in identifying a recruitment pathway that would ensure feasibility of study continuation. We have had multiple meetings with CSR\&D leadership to discuss our study progress",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 11:55:28.299041,2024-10-15 11:55:28.299041,FED,,,,,,,2024,0.0
NCT03353428,,2017-11-20,,,2018-03-25,2017-11-22,2017-11-27,ACTUAL,,,,,,,2018-03-25,2018-03-27,ACTUAL,2017-11-15,ACTUAL,2017-11-15,2018-03,2018-03-31,2020-12,ESTIMATED,2020-12-31,2019-01,ESTIMATED,2019-01-31,,INTERVENTIONAL,,,Intervention of Engineered Immune Effector T Cells Against Lung Cancer,Interventional Treatment of Lung Cancer (LC) With LC Specific Immune Lymphocytes (LC-CTLs),WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Shenzhen Geno-Immune Medical Institute,,1.0,,combine with NCT03356808,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 11:55:28.299041,2024-10-15 11:55:28.299041,OTHER,,,,,,,2020,0.0
NCT03774875,,2018-12-11,2021-12-14,,2022-12-08,2018-12-11,2018-12-13,ACTUAL,2021-12-14,2022-01-13,ACTUAL,,,,2022-12-08,2022-12-12,ACTUAL,2019-03-28,ACTUAL,2019-03-28,2022-12,2022-12-31,2021-11-03,ACTUAL,2021-11-03,2021-02-01,ACTUAL,2021-02-01,,INTERVENTIONAL,EMBRACE,All randomized participants,"A Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Adults With Manifestations of Plaque Psoriasis and Impaired Quality of Life","A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Subjects With Manifestations of Plaque Psoriasis and Impaired Quality of Life",COMPLETED,,PHASE4,277.0,ACTUAL,Amgen,,2.0,,,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,INDUSTRY,,,,,,,2021,1.0
NCT03906526,,2018-12-05,,,2023-02-23,2019-04-04,2019-04-08,ACTUAL,,,,,,,2023-02-23,2023-02-24,ACTUAL,2019-07-03,ACTUAL,2019-07-03,2023-02,2023-02-28,2022-01-24,ACTUAL,2022-01-24,2022-01-24,ACTUAL,2022-01-24,,INTERVENTIONAL,,,A Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer,A Phase 1b Multicenter Pre-Surgical Study to Evaluate Immune Biomarker Modulation in Response to Motolimod (VTX-2337) in Combination With Nivolumab in Subjects With Resectable Squamous Cell Carcinoma of the Head and Neck (SCCHN),TERMINATED,,PHASE1,15.0,ACTUAL,Celgene,,4.0,,Business objectives have changed,f,,,,t,t,f,,,,,,See Plan Description,See Plan Description,https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,INDUSTRY,,,,,,,2022,0.0
NCT04578015,,2020-10-01,2023-03-20,,2023-05-21,2020-10-01,2020-10-08,ACTUAL,2023-05-21,2023-06-15,ACTUAL,,,,2023-05-21,2023-06-15,ACTUAL,2021-04-26,ACTUAL,2021-04-26,2023-05,2023-05-31,2022-02-09,ACTUAL,2022-02-09,2022-02-09,ACTUAL,2022-02-09,,INTERVENTIONAL,,"Baseline analysis population data was not obtained as participants assigned to the treatment and placebo group did not complete the study, and this study was terminated due to lack of participant enrollment before data could be collected. No baseline data was collected.",A Randomized Controlled Trial of Treatment of Bacterial Vaginosis,A Randomized Controlled Trial of Treatment of Bacterial Vaginosis in Late Third Trimester to Prevent Maternal Peripartum Infection,TERMINATED,,PHASE4,16.0,ACTUAL,Ohio State University,,2.0,,"After screening many patients for BV, it was determined that the rate of BV is less in our population that the 30% rate mentioned in the literature. It was determined that completing the study will not be feasible due to cost and time constraints.",f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,OTHER,,,,,,,2022,0.0
NCT02408328,,2015-03-31,,,2019-10-23,2015-04-02,2015-04-03,ESTIMATED,,,,,,,2019-10-23,2019-10-24,ACTUAL,2020-06,ESTIMATED,2020-06-30,2019-10,2019-10-31,2021-05,ESTIMATED,2021-05-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Management of Apnea in Late Preterm and Term Infants,Management of Apnea in Late Preterm and Term Infants,WITHDRAWN,,PHASE2,0.0,ACTUAL,Boston Children's Hospital,,2.0,,Transition to new position,f,,,,t,f,f,,,,,,,,,,,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,OTHER,,,,,,,2021,0.0
NCT04713176,,2021-01-14,,,2023-09-27,2021-01-14,2021-01-19,ACTUAL,,,,,,,2023-09-27,2023-09-29,ACTUAL,2021-02-02,ACTUAL,2021-02-02,2023-09,2023-09-30,2022-12-09,ACTUAL,2022-12-09,2022-05-02,ACTUAL,2022-05-02,,INTERVENTIONAL,,,Efficacy and Safety of DWJ1248 With Remdesivir in Severe COVID-19 Patients,"A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DW1248 With Remdesivir in Severe COVID-19 Patients",TERMINATED,,PHASE3,240.0,ACTUAL,Daewoong Pharmaceutical Co. LTD.,,2.0,,Termination of study due to sponsor's internal decision,f,,,,,f,f,,,,,,,,,,,2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,INDUSTRY,,,,,,,2022,0.0
NCT04019769,,2019-07-12,,,2020-03-13,2019-07-12,2019-07-15,ACTUAL,,,,,,,2020-03-13,2020-03-16,ACTUAL,2020-03-12,ESTIMATED,2020-03-12,2020-03,2020-03-31,2021-01-01,ESTIMATED,2021-01-01,2021-01-01,ESTIMATED,2021-01-01,,INTERVENTIONAL,,,Glutamine Supplementation in People With Immune Dysregulation,Phase 1 Trial of Glutamine Supplementation in Patients With Immune Dysregulation,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,PI left NIH. No subjects enrolled.,f,,,,,f,f,,,,,,,,,,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,NIH,,,,,,,2021,0.0
NCT04511819,,2020-08-08,2024-02-16,2022-03-30,2024-02-16,2020-08-11,2020-08-13,ACTUAL,2024-02-16,2024-03-13,ACTUAL,2022-03-30,2022-04-04,ACTUAL,2024-02-16,2024-03-13,ACTUAL,2020-08-28,ACTUAL,2020-08-28,2024-02,2024-02-29,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,LOSVID,Full Analysis Set: included all participants who were randomized and received any study drug.,Losmapimod Safety and Efficacy in COVID-19,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Losmapimod in Adult Subjects With COVID-19 (LOSVID STUDY)",TERMINATED,,PHASE3,52.0,ACTUAL,Fulcrum Therapeutics,,2.0,,Study terminated due to the rapidly evolving environment for the treatment of Covid-19 and ongoing challenges to identify and enroll qualified patients to participate.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,INDUSTRY,,,,,,,2021,0.0
NCT02382549,,2015-03-02,,,2023-12-06,2015-03-05,2015-03-06,ESTIMATED,,,,,,,2023-12-06,2023-12-12,ACTUAL,2016-04,,2016-04-30,2023-12,2023-12-31,2022-02-28,ACTUAL,2022-02-28,2022-02-28,ACTUAL,2022-02-28,,INTERVENTIONAL,Mel61,,A Clinical Trial to Evaluate a Melanoma Helper Peptide Vaccine Plus Dabrafenib and Trametinib,A TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A HELPER PEPTIDE VACCINE PLUS COMBINATION OF BRAF INHIBITION AND MEK INHIBITION (MEL61),TERMINATED,,EARLY_PHASE1,8.0,ACTUAL,University of Virginia,,1.0,,The study was terminated because of slow accruals.,f,,,,t,,,,,,,,,,,,,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,OTHER,,,,,,,2022,0.0
NCT04412057,,2020-05-29,2022-02-24,,2022-03-22,2020-05-29,2020-06-02,ACTUAL,2022-02-24,2022-03-04,ACTUAL,,,,2022-03-22,2022-03-24,ACTUAL,2020-07-17,ACTUAL,2020-07-17,2022-03,2022-03-31,2021-01-19,ACTUAL,2021-01-19,2020-12-14,ACTUAL,2020-12-14,,INTERVENTIONAL,,Randomized Analysis Set,Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury,"A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury",COMPLETED,,PHASE2,88.0,ACTUAL,"Avalo Therapeutics, Inc.","The study was designed to use broad eligibility criteria including patients who received high-flow oxygen or positive-pressure oxygen prior to randomization. Some overlap was expected between the entry criteria and the primary endpoint. Therefore patients who were in respiratory failure before dosing or who required an elevation in their ventilation support were excluded (N=20). In addition, to increase statistical power, a 1-sided χ2 test was used.",2.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,INDUSTRY,,,,,,,2021,1.0
NCT03537157,,2018-05-15,,,2021-09-24,2018-05-24,2018-05-25,ACTUAL,,,,,,,2021-09-24,2021-09-27,ACTUAL,2017-11-16,ACTUAL,2017-11-16,2021-07,2021-07-31,2020-07-29,ACTUAL,2020-07-29,2020-07-15,ACTUAL,2020-07-15,,INTERVENTIONAL,STOP-PER,,A Multicentre Study on Rifaximin in Post-operative Endoscopic Crohn's Disease Recurrence Prevention,"A Phase II, Multicentre, Double-blind, Randomised, Placebo-controlled Study of Rifaximin Delayed Release 400 mg Tablet: Clinical Efficacy and Safety in the Prevention of Post-operative Endoscopic Crohn's Disease Recurrence",TERMINATED,,PHASE2,43.0,ACTUAL,Alfasigma S.p.A.,,2.0,,The decision to prematurely close the trial recruitment period was taken due to the difficulties in the recruitment of patients. This decision has not been triggered by any unexpected safety signals identified during the study conduction.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,INDUSTRY,,,,,,,2020,0.0
NCT03444870,,2018-02-19,2023-12-22,,2024-01-25,2018-02-19,2018-02-23,ACTUAL,2024-01-25,2024-01-30,ACTUAL,,,,2024-01-25,2024-01-30,ACTUAL,2018-06-06,ACTUAL,2018-06-06,2024-01,2024-01-31,2023-02-17,ACTUAL,2023-02-17,2022-12-28,ACTUAL,2022-12-28,,INTERVENTIONAL,,"ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. ITT analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.",Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD),"A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease",TERMINATED,,PHASE3,1053.0,ACTUAL,Hoffmann-La Roche,,2.0,,Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early-stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I\&II (WN29922/WN39658).,,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,INDUSTRY,,,,,,,2023,0.0
NCT04510207,,2020-08-03,,,2023-06-15,2020-08-10,2020-08-12,ACTUAL,,,,,,,2023-06-15,2023-06-18,ACTUAL,2020-07-16,ACTUAL,2020-07-16,2023-06,2023-06-30,2021-12-31,ACTUAL,2021-12-31,2021-06-16,ACTUAL,2021-06-16,,INTERVENTIONAL,COVID-19,,"A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above","Multicenter, Randomized, Double Blind, Parallel Placebo Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above",COMPLETED,,PHASE3,44101.0,ACTUAL,China National Biotec Group Company Limited,,6.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,INDUSTRY,,,,,,,2021,1.0
NCT03998436,,2019-06-24,2023-08-25,,2023-08-25,2019-06-25,2019-06-26,ACTUAL,2023-08-25,2023-09-22,ACTUAL,,,,2023-08-25,2023-09-22,ACTUAL,2018-12-26,ACTUAL,2018-12-26,2023-08,2023-08-31,2021-12-06,ACTUAL,2021-12-06,2021-08-19,ACTUAL,2021-08-19,,INTERVENTIONAL,,,Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers,"A Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Study to Evaluate the Safety and Efficacy of a Gel Formulation of Esmolol Hydrochloride (Galnobax®) in Treating Diabetic Foot Ulcers",COMPLETED,,PHASE3,176.0,ACTUAL,Novalead Pharma Private Limited,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,INDUSTRY,,,,,,,2021,1.0
NCT03736629,,2018-11-07,2022-11-23,,2023-08-03,2018-11-08,2018-11-09,ACTUAL,2023-08-03,2023-08-23,ACTUAL,,,,2023-08-03,2023-08-23,ACTUAL,2019-02-01,ACTUAL,2019-02-01,2023-08,2023-08-31,2022-06-01,ACTUAL,2022-06-01,2021-03-01,ACTUAL,2021-03-01,,INTERVENTIONAL,,,Azithromycin Treatment for the Airway Microbiome in Asthma,The AZITRAMBA Trial: Azithromycin Treatment for the Airway Microbiome in Asthma,TERMINATED,,PHASE2,17.0,ACTUAL,University of Chicago,Early termination leading to small numbers of subjects analyzed.,3.0,,"Inability to accrue patients, particularly after COVID pandemic.",f,,,,t,t,f,,,t,,,"Upon publication of the major manuscript to be generated from this study. Data will be deposited in an appropriate major database (e.g., sequencing information will be deposited in a genetics bio-bank).",All qualified investigators who sign appropriate data use agreements and material transfer agreements with the University of Chicago and Northwestern University,,YES,We will share individual participant data that is de-identified available to all qualified investigators,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,OTHER,,,,,,,2022,0.0
NCT06138327,,2023-10-18,,,2024-06-10,2023-11-16,2023-11-18,ACTUAL,,,,,,,2024-06-10,2024-06-11,ACTUAL,2023-09-26,ACTUAL,2023-09-26,2024-06,2024-06-30,2024-03-25,ACTUAL,2024-03-25,2024-03-25,ACTUAL,2024-03-25,,INTERVENTIONAL,,,A Study of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease And Hyperoxaluria,"A Phase 1b, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, 2-Period Crossover Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Oral Administration of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease (NAFLD) And Hyperoxaluria",WITHDRAWN,,PHASE1,0.0,ACTUAL,BioMarin Pharmaceutical,,2.0,,The study was withdrawn because BioMarin decided to end the overall development program. The study withdrawal was not due to any patient safety concerns.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,INDUSTRY,,,,,,,2024,0.0
NCT03437044,,2018-02-12,2021-01-19,,2021-11-02,2018-02-12,2018-02-19,ACTUAL,2021-01-19,2021-02-05,ACTUAL,,,,2021-11-02,2021-11-30,ACTUAL,2018-03-14,ACTUAL,2018-03-14,2021-11,2021-11-30,2020-06-27,ACTUAL,2020-06-27,2019-06-27,ACTUAL,2019-06-27,,INTERVENTIONAL,OPTIMUS-6,,Low Maintenance Dose Ticagrelor Versus Clopidogrel in Diabetes Patients Undergoing PCI,A Randomized Comparison of Platelet Inhibition Using a Low Maintenance Dose Ticagrelor Regimen Versus Standard Dose Clopidogrel in Diabetes Mellitus Patients Without Prior Major Cardiovascular Events Undergoing Elective Percutaneous Coronary Intervention: The OPTIMUS (Optimizing Antiplatelet Therapy in Diabetes Mellitus)-6 Study,COMPLETED,,PHASE4,40.0,ACTUAL,University of Florida,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,OTHER,,,,,,,2020,1.0
NCT04528199,,2020-08-24,,,2024-01-11,2020-08-24,2020-08-27,ACTUAL,,,,,,,2024-01-11,2024-01-16,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2024-01,2024-01-31,2023-04-21,ACTUAL,2023-04-21,2023-04-21,ACTUAL,2023-04-21,,INTERVENTIONAL,,,[18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer,A Phase 1 Study of [18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer,TERMINATED,,PHASE1,8.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,The Principal Investigator decided to terminate the study because the PI left Hopkins.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,OTHER,,,,,,,2023,0.0
NCT03682744,,2018-09-21,,,2022-03-25,2018-09-21,2018-09-25,ACTUAL,,,,,,,2022-03-25,2022-04-06,ACTUAL,2018-09-13,ACTUAL,2018-09-13,2022-03,2022-03-31,2021-03,ESTIMATED,2021-03-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC),Immunotherapy for Peritoneal Carcinomatosis (IPC) - A Phase I Study of the Safety and Efficacy of Anti-CEA CAR-T Cell Intraperitoneal Infusions for Treatment of CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites,WITHDRAWN,,PHASE1,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,1.0,,Unable to enroll subjects,f,,,,t,t,f,,,,,,,,,,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,INDUSTRY,,,,,,,2021,0.0
NCT05842967,,2023-04-24,,,2024-04-08,2023-04-24,2023-05-06,ACTUAL,,,,,,,2024-04-08,2024-04-09,ACTUAL,2023-05-11,ACTUAL,2023-05-11,2024-04,2024-04-30,2024-03-18,ACTUAL,2024-03-18,2024-03-18,ACTUAL,2024-03-18,,INTERVENTIONAL,MONET,,"A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Adults at High Risk of Severe RSV Disease","A PHASE 3 PROTOCOL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS AT HIGH RISK OF SEVERE RSV DISEASE",COMPLETED,,PHASE3,886.0,ACTUAL,Pfizer,,3.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,INDUSTRY,,,,,,,2024,1.0
NCT04607005,,2020-10-23,,,2024-02-13,2020-10-23,2020-10-28,ACTUAL,,,,,,,2024-02-13,2024-02-14,ACTUAL,2021-02-08,ACTUAL,2021-02-08,2024-02,2024-02-29,2023-04-12,ACTUAL,2023-04-12,2023-04-12,ACTUAL,2023-04-12,,INTERVENTIONAL,MERIT,,Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS),"A Randomised, Double-blind, Placebo Controlled, Parallel Group Phase III Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) / Eosinophilic Chronic Rhinosinusitis (ECRS) MERIT: Mepolizumab in Eosinophilic Chronic RhinosinusITis Study",COMPLETED,,PHASE3,169.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,f,f,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,INDUSTRY,,,,,,,2023,1.0
NCT04346615,,2020-04-09,2024-04-05,2022-12-15,2024-04-05,2020-04-10,2020-04-15,ACTUAL,2024-04-05,2024-05-02,ACTUAL,2022-12-15,2022-12-19,ACTUAL,2024-04-05,2024-05-02,ACTUAL,2020-04-25,ACTUAL,2020-04-25,2024-04,2024-04-30,2022-04-29,ACTUAL,2022-04-29,2022-04-29,ACTUAL,2022-04-29,,INTERVENTIONAL,,Safety analysis set included all participants who received \>=1 dose of study drug (zavegapant or placebo),Safety and Efficacy Trial of Zavegepant* Intranasal for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen,"BHV3500-203: Phase 2/3: Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of Zavegepant (BHV-3500) Intranasal (IN) for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen",TERMINATED,,PHASE2/PHASE3,47.0,ACTUAL,Pfizer,,2.0,,Lack of enrollment due to evolution of COVID-19 pandemic with reduction in patients at risk for severe disease and growing number of effective alternative therapies,f,,,,,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 11:55:28.299041,2024-10-15 11:55:28.299041,INDUSTRY,,,,,,,2022,0.0
NCT03629015,,2018-07-30,,,2022-10-26,2018-08-09,2018-08-14,ACTUAL,,,,,,,2022-10-26,2022-10-28,ACTUAL,2018-10-01,ESTIMATED,2018-10-01,2022-10,2022-10-31,2020-05-18,ACTUAL,2020-05-18,2020-05-18,ACTUAL,2020-05-18,,INTERVENTIONAL,ALF,,Safety Study of Stemchymal® in Acute Liver Failure,"The Safety Study of Stemchymal® (Allogeneic Adipose-Derived Mesenchymal Stem Cells) Treating on Acute Liver Failure - An Open-Label, Single-Center Phase I Trial",WITHDRAWN,,PHASE1,0.0,ACTUAL,Steminent Biotherapeutics Inc.,,1.0,,Corporate strategic consideration,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 11:55:28.299041,2024-10-15 11:55:28.299041,INDUSTRY,,,,,,,2020,0.0
NCT03716076,,2018-10-17,2020-09-08,,2021-04-22,2018-10-19,2018-10-23,ACTUAL,2021-04-22,2021-05-14,ACTUAL,,,,2021-04-22,2021-05-14,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2021-04,2021-04-30,2020-04-24,ACTUAL,2020-04-24,2019-06-15,ACTUAL,2019-06-15,,INTERVENTIONAL,CaRDIO,,Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study,The Effect of Carbetocin Dose on Dispersion of Myocardial Repolarization in Healthy Parturients Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia,COMPLETED,,PHASE4,50.0,ACTUAL,University of British Columbia,"No data exists that stratifies risk by measuring absolute Tp-e change We excluded patients with low repolarization reserves, or a resistance to oxytocin. We also excluded emergent C-sections, combined spinal/epidurals, and General Anesthesia",2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,OTHER,,,,,,,2020,1.0
NCT03149640,,2017-05-02,,,2022-11-04,2017-05-09,2017-05-11,ACTUAL,,,,,,,2022-11-04,2022-11-07,ACTUAL,2017-07-19,ACTUAL,2017-07-19,2022-11,2022-11-30,2021-06-17,ACTUAL,2021-06-17,2021-03-09,ACTUAL,2021-03-09,,INTERVENTIONAL,AMIKINHAL,,Study Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia,Double-blinded Multicenter Randomized Controlled Trial Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia,COMPLETED,,PHASE3,850.0,ACTUAL,"University Hospital, Tours",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 11:55:28.299041,2024-10-15 11:55:28.299041,OTHER,,,,,,,2021,1.0
NCT03927690,,2019-04-23,2023-08-04,2023-05-01,2024-06-17,2019-04-23,2019-04-25,ACTUAL,2023-09-21,2023-10-12,ACTUAL,,2023-10-12,ACTUAL,2024-06-17,2024-06-20,ACTUAL,2019-05-24,ACTUAL,2019-05-24,2024-06,2024-06-30,2022-08-31,ACTUAL,2022-08-31,2022-06-17,ACTUAL,2022-06-17,,INTERVENTIONAL,,,Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema,"A Randomized, Active-controlled, Patient and Investigator-masked, Multiple Dose Proof-of-concept Study of Intravitreal LKA651 in Patients With Diabetic Macular Edema",COMPLETED,,PHASE2,91.0,ACTUAL,Novartis,,3.0,,,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,INDUSTRY,,,,,,,2022,1.0
NCT02219711,,2014-08-14,,,2023-03-02,2014-08-15,2014-08-19,ESTIMATED,,,,,,,2023-03-02,2023-03-06,ACTUAL,2014-08,,2014-08-31,2023-03,2023-03-31,2022-04-27,ACTUAL,2022-04-27,2022-04-27,ACTUAL,2022-04-27,,INTERVENTIONAL,,,Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer,A Phase 1/1b Study of MGCD516 in Patients With Advanced Solid Tumor Malignancies,COMPLETED,,PHASE1,193.0,ACTUAL,Mirati Therapeutics Inc.,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,INDUSTRY,,,,,,,2022,1.0
NCT04617860,,2020-10-30,2021-12-17,,2022-01-19,2020-10-30,2020-11-05,ACTUAL,2022-01-19,2022-02-09,ACTUAL,,,,2022-01-19,2022-02-09,ACTUAL,2019-09-24,ACTUAL,2019-09-24,2022-01,2022-01-31,2021-04-29,ACTUAL,2021-04-29,2021-04-29,ACTUAL,2021-04-29,,INTERVENTIONAL,,,Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease,"A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120102 in Patients With Huntington's Disease",TERMINATED,,PHASE1/PHASE2,36.0,ACTUAL,Wave Life Sciences Ltd.,,1.0,,Lack of efficacy,f,,,,t,t,f,,,t,,,,,,,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,INDUSTRY,,,,,,,2021,0.0
NCT05114460,,2021-10-05,,,2024-08-26,2021-11-09,2021-11-10,ACTUAL,,,,,,,2024-08-26,2024-08-27,ACTUAL,2021-11-01,ACTUAL,2021-11-01,2024-08,2024-08-31,2024-12-30,ESTIMATED,2024-12-30,2024-09-30,ESTIMATED,2024-09-30,,INTERVENTIONAL,,,Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal,The Ability of Vaped Marijuana to Reduce the Severity of Naloxone-Precipitated Withdrawal,SUSPENDED,,PHASE2,32.0,ESTIMATED,New York State Psychiatric Institute,,6.0,,"The U.S. Department of Health and Human Services Office of Human Research Protections issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 11:55:28.299041,2024-10-15 11:55:28.299041,OTHER,,,,,,,2024,0.0
NCT03515200,,2018-04-19,,,2020-08-28,2018-05-01,2018-05-03,ACTUAL,,,,,,,2020-08-28,2020-09-01,ACTUAL,2018-04-20,ACTUAL,2018-04-20,2020-08,2020-08-31,2020-07-29,ACTUAL,2020-07-29,2020-07-29,ACTUAL,2020-07-29,,INTERVENTIONAL,,,Treatment With Combination Chemotherapy for Relapsed or Refractory Acute Lymphoblastic Leukemia,A Phase I Study of Palbociclib in Combination With Chemotherapy in Pediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia,TERMINATED,,PHASE1,12.0,ACTUAL,St. Jude Children's Research Hospital,,1.0,,Due to departure of PI from St. Jude,,,,,f,t,f,,,,,,,,,,,2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,OTHER,,,,,,,2020,0.0
NCT03398148,,2018-01-08,,2023-07-25,2023-07-25,2018-01-08,2018-01-12,ACTUAL,,,,,,,2023-07-25,2023-08-01,ACTUAL,2018-03-07,ACTUAL,2018-03-07,2023-07,2023-07-31,2023-05-11,ACTUAL,2023-05-11,2022-11-09,ACTUAL,2022-11-09,,INTERVENTIONAL,,,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis",COMPLETED,,PHASE2/PHASE3,1558.0,ACTUAL,AbbVie,,15.0,,,f,,,,t,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,INDUSTRY,,,,,,,2023,0.0
NCT03498716,,2018-02-28,2024-07-29,,2024-07-29,2018-04-12,2018-04-17,ACTUAL,2024-07-29,2024-08-21,ACTUAL,,,,2024-07-29,2024-08-21,ACTUAL,2018-08-02,ACTUAL,2018-08-02,2024-07,2024-07-31,2023-08-14,ACTUAL,2023-08-14,2023-08-14,ACTUAL,2023-08-14,,INTERVENTIONAL,IMpassion030,"Intent-to-Treat (ITT) population included all randomized participants, whether or not the assigned study treatment was received.",A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer,"A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer",TERMINATED,,PHASE3,2199.0,ACTUAL,Hoffmann-La Roche,,2.0,,The study was terminated by the sponsor following interim analysis as the primary endpoint of iDFS crossed the pre-specified futility boundary of hazard ratio \> 1 in the Intent-to-Treat (ITT) population.,f,,,,t,t,f,,,,,,,,,,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,INDUSTRY,,,,,,,2023,0.0
NCT02783404,,2016-05-22,,,2022-05-17,2016-05-25,2016-05-26,ESTIMATED,,,,,,,2022-05-17,2022-05-24,ACTUAL,2017-02-27,ACTUAL,2017-02-27,2022-05,2022-05-31,2022-05-17,ACTUAL,2022-05-17,2021-12-01,ACTUAL,2021-12-01,,INTERVENTIONAL,,,An Oral Amoxicillin-Clavulanate Regimen to Prevent Bacteremia Following Dental Procedures,An Oral Amoxicillin-Clavulanate Regimen to Prevent Bacteremia Following,TERMINATED,,PHASE4,40.0,ACTUAL,University of Santiago de Compostela,,3.0,,Significant results (no control neither amoxicillin new arms needed),f,,,,f,f,f,,,f,,,By the end of the study (for 1 year),On request,,YES,IPD will be available on request,2024-10-15 11:55:28.299041,2024-10-15 11:55:28.299041,OTHER,,,,,,,2022,0.0
NCT02924376,,2016-10-04,2023-01-26,,2023-01-26,2016-10-04,2016-10-05,ESTIMATED,2023-01-26,2023-02-23,ACTUAL,,,,2023-01-26,2023-02-23,ACTUAL,2017-01-16,ACTUAL,2017-01-16,2023-01,2023-01-31,2022-02-01,ACTUAL,2022-02-01,2022-02-01,ACTUAL,2022-02-01,,INTERVENTIONAL,,,Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202),"A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy - (FIGHT-202)",COMPLETED,,PHASE2,147.0,ACTUAL,Incyte Corporation,,3.0,,,t,,,,f,t,,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,INDUSTRY,,NCT03906357,NO_LONGER_AVAILABLE,,,,2022,1.0
NCT03337724,,2017-11-07,2024-01-02,,2024-02-15,2017-11-07,2017-11-09,ACTUAL,2024-02-15,2024-03-12,ACTUAL,,,,2024-02-15,2024-03-12,ACTUAL,2018-01-06,ACTUAL,2018-01-06,2024-02,2024-02-29,2023-01-04,ACTUAL,2023-01-04,2023-01-04,ACTUAL,2023-01-04,,INTERVENTIONAL,IPATunity130,"Intention-to-treat (ITT) Population included all randomized participants in Cohorts A and B regardless of whether the participants received the assigned treatment. For Cohort C, the ITT population consisted of all enrolled participants in Cohort C.","A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer","A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer",COMPLETED,,PHASE3,579.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 11:55:28.299041,2024-10-15 11:55:28.299041,INDUSTRY,,,,,,,2023,1.0
NCT02859064,,2016-08-01,2023-05-26,,2023-12-01,2016-08-03,2016-08-08,ESTIMATED,2023-07-07,2023-07-27,ACTUAL,,,,2023-12-01,2023-12-05,ACTUAL,2017-07-28,ACTUAL,2017-07-28,2023-07,2023-07-31,2022-06-10,ACTUAL,2022-06-10,2022-05-27,ACTUAL,2022-05-27,,INTERVENTIONAL,,All patients who received at least one dose of treatment of lanreotide and Y-90 microspheres.,Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres,A Phase II Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres (SIR-Spheres®),TERMINATED,,PHASE2,6.0,ACTUAL,"SCRI Development Innovations, LLC",,1.0,,Closed due to slow accrual,f,,,,f,t,t,,,f,,,,,,NO,,2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,OTHER,,,,,,,2022,0.0
NCT02120157,,2014-04-16,2019-03-28,,2021-11-23,2014-04-18,2014-04-22,ESTIMATED,2019-03-28,2019-04-18,ACTUAL,,,,2021-11-23,2021-11-26,ACTUAL,2015-07-02,ACTUAL,2015-07-02,2021-11,2021-11-30,2020-10-01,ACTUAL,2020-10-01,2018-06-15,ACTUAL,2018-06-15,,INTERVENTIONAL,,,Myeloablative Haploidentical BMT With Post-transplant Cyclophosphamide for Pediatric Patients With Hematologic Malignancies,Pediatric Blood & Marrow Transplant Consortium (PBMTC) Phase II Myeloablative Haploidentical BMT With Post-transplantation Cyclophosphamide for Pediatric Patients With Hematologic Malignancies,COMPLETED,,PHASE2,35.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,OTHER,,,,,,,2020,1.0
NCT02452268,,2015-03-02,,,2023-03-01,2015-05-20,2015-05-22,ESTIMATED,,,,,,,2023-03-01,2023-03-03,ACTUAL,2017-05-08,ACTUAL,2017-05-08,2023-03,2023-03-31,2022-03-07,ACTUAL,2022-03-07,2022-03-07,ACTUAL,2022-03-07,,INTERVENTIONAL,,,A Phase I/Ib Study of NIZ985 in Combination With PDR001 in Adults With Metastatic Cancers,A Phase 1 Study of Subcutaneous Recombinant Human NIZ985 ((hetIL-15) (IL15/sIL-15Ra)) Alone and in Combination With PDR001 in Adults With Metastatic Cancers,TERMINATED,,PHASE1,83.0,ACTUAL,Novartis,,2.0,,business decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,INDUSTRY,,,,,,,2022,0.0
NCT04441099,,2020-06-18,,,2023-09-04,2020-06-18,2020-06-22,ACTUAL,,,,,,,2023-09-04,2023-09-07,ACTUAL,2020-06-19,ACTUAL,2020-06-19,2023-07,2023-07-31,2023-08-14,ACTUAL,2023-08-14,2023-08-14,ACTUAL,2023-08-14,,INTERVENTIONAL,,,NBE-002 in Patients With Advanced Solid Tumors,"A First-in-Human, Phase 1/2 Study of NBE-002, an Anti-ROR1 Antibody Drug Conjugate, in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,NBE-Therapeutics AG,,4.0,,End of Program,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,INDUSTRY,,,,,,,2023,0.0
NCT02638519,,2015-12-03,,,2024-10-08,2015-12-18,2015-12-23,ESTIMATED,,,,,,,2024-10-08,2024-10-11,ESTIMATED,2016-06-27,ACTUAL,2016-06-27,2024-08,2024-08-31,2022-04-19,ACTUAL,2022-04-19,2022-04-19,ACTUAL,2022-04-19,,INTERVENTIONAL,,,HP Xenon-129 fMRI of Healthy Volunteers and Participants With Alzheimer's Disease,Hyperpolarized Xenon-129 Functional Magnetic Resonance Imaging of Healthy Volunteers and Participants With Alzheimer's Disease,TERMINATED,,EARLY_PHASE1,51.0,ACTUAL,Thunder Bay Regional Health Research Institute,,2.0,,Unable to reach the target enrollment of 40 participants with Alzheimer's disease.,f,,,,f,,,,,,,,,,,,,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,OTHER,,,,,,,2022,0.0
NCT04374474,,2020-04-29,,,2022-08-29,2020-05-01,2020-05-05,ACTUAL,,,,,,,2022-08-29,2022-08-30,ACTUAL,2021-01-10,ESTIMATED,2021-01-10,2020-07,2020-07-31,2022-03-10,ESTIMATED,2022-03-10,2021-12-10,ESTIMATED,2021-12-10,,INTERVENTIONAL,,,Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19),Olfactory Retraining Therapy and Budesonide Nasal Rinse for Anosmia Treatment in Patients Post-CoVID 19. A Randomized Controlled Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,Lawson Health Research Institute,,3.0,,Study withdrawn before any enrollment (site's research goals adjustments).,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,OTHER,,,,,,,2022,0.0
NCT03499119,,2018-03-07,2022-11-04,,2024-05-10,2018-04-13,2018-04-17,ACTUAL,2023-09-26,2024-03-28,ACTUAL,,,,2024-05-10,2024-05-28,ACTUAL,2018-05-04,ACTUAL,2018-05-04,2024-05,2024-05-31,2021-11-23,ACTUAL,2021-11-23,2021-11-23,ACTUAL,2021-11-23,,INTERVENTIONAL,,The full analysis set included all randomized participants.,AMG 334 20160172 Pediatric Migraine PK Study.,"A Phase I, Randomized, Open-label, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine",COMPLETED,,PHASE1,53.0,ACTUAL,Amgen,,2.0,,,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,INDUSTRY,,,,,,,2021,1.0
NCT04294654,,2020-03-02,,,2022-08-05,2020-03-02,2020-03-04,ACTUAL,,,,,,,2022-08-05,2022-08-08,ACTUAL,2020-02-28,ACTUAL,2020-02-28,2022-08,2022-08-31,2022-07-20,ACTUAL,2022-07-20,2022-07-06,ACTUAL,2022-07-06,,INTERVENTIONAL,MEMORY,,Vortioxetine in Patients With Depression and Early Dementia,"Interventional, Open-label Study of Flexible Doses of Vortioxetine on Depressive Symptoms in Patients With Major Depressive Disorder and Early Dementia",COMPLETED,,PHASE4,82.0,ACTUAL,H. Lundbeck A/S,,1.0,,,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,INDUSTRY,,,,,,,2022,1.0
NCT04113889,,2019-09-26,,,2020-01-30,2019-10-02,2019-10-03,ACTUAL,,,,,,,2020-01-30,2020-02-05,ACTUAL,2019-10-15,ACTUAL,2019-10-15,2020-01,2020-01-31,2020-01-30,ACTUAL,2020-01-30,2020-01-30,ACTUAL,2020-01-30,,INTERVENTIONAL,PCOS,,"Effects of Triple Drug Cocktail Therapy on Metabolic, Endocrine Alterations and Perceived Stress in Patients With Poly Cystic Ovary Syndrome","Effects of Triple Drug Cocktail Therapy on Metabolic, Endocrine Alterations and Perceived Stress Response in Patients With PCOS: A Double Blind Randomized Clinical Trial",COMPLETED,,PHASE2,147.0,ACTUAL,Khyber Medical University Peshawar,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,OTHER,,,,,,,2020,1.0
NCT03451006,,2018-01-30,2022-10-24,,2022-10-24,2018-02-23,2018-03-01,ACTUAL,2022-10-24,2022-11-17,ACTUAL,,,,2022-10-24,2022-11-17,ACTUAL,2018-05-24,ACTUAL,2018-05-24,2022-10,2022-10-31,2021-12-16,ACTUAL,2021-12-16,2021-12-16,ACTUAL,2021-12-16,,INTERVENTIONAL,,,Effect of Metformin on Frailty in 12 Subjects,(MATE) Metformin and Aging Trial in the Elderly: A Pilot and Feasibility Study,TERMINATED,,PHASE2,7.0,ACTUAL,Mayo Clinic,Study was terminated due to recruitment being difficult and not achieved.,2.0,,difficult recruitment and not achieved,f,,,,t,t,f,,,f,,,,,,NO,No plan to do that,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,OTHER,,,,,,,2021,0.0
NCT02400814,,2015-01-22,,,2022-08-02,2015-03-23,2015-03-27,ESTIMATED,,,,,,,2022-08-02,2022-08-04,ACTUAL,2015-12-03,ACTUAL,2015-12-03,2022-08,2022-08-31,2021-09-29,ACTUAL,2021-09-29,2021-09-29,ACTUAL,2021-09-29,,INTERVENTIONAL,,,MPDL3280A and Stereotactic Ablative Radiotherapy in Patients With Non-small Cell Lung Cancer,Pilot Study of MPDL3280A Plus Stereotactic Ablative Radiotherapy (SAR) in Stage IV Non-small Cell Lung Cancer,TERMINATED,,PHASE1,27.0,ACTUAL,"University of California, Davis",,3.0,,Enrollment halted due to slow accrual.,f,,,,t,,,,,,,,,,,,,2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,OTHER,,,,,,,2021,0.0
NCT03487848,,2018-03-20,2021-03-12,,2021-04-16,2018-04-02,2018-04-04,ACTUAL,2021-04-16,2021-04-20,ACTUAL,,,,2021-04-16,2021-04-20,ACTUAL,2018-06-25,ACTUAL,2018-06-25,2021-04,2021-04-30,2020-09-17,ACTUAL,2020-09-17,2018-10-18,ACTUAL,2018-10-18,,INTERVENTIONAL,,,Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection,"Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children From 3 to Less Than 18 Years of Age With GT-1 to -6 Chronic Hepatitis C (CHC) Infection",TERMINATED,,PHASE2,5.0,ACTUAL,Bristol-Myers Squibb,This study was terminated early by sponsor for reasons unrelated to safety.,1.0,,Business objectives have changed,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,INDUSTRY,,,,,,,2020,0.0
NCT02608229,,2015-11-16,2020-03-27,,2021-04-19,2015-11-17,2015-11-18,ESTIMATED,2020-04-21,2020-05-01,ACTUAL,,,,2021-04-19,2021-04-21,ACTUAL,2016-06-06,ACTUAL,2016-06-06,2021-04,2021-04-30,2020-05-21,ACTUAL,2020-05-21,2019-03-27,ACTUAL,2019-03-27,,INTERVENTIONAL,,,BVD-523 Plus Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer,Phase Ib Study of BVD-523 Plus Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer,TERMINATED,,PHASE1,18.0,ACTUAL,Washington University School of Medicine,,2.0,,Adverse events,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,OTHER,,,,,,,2020,0.0
NCT03342937,,2017-11-10,2024-01-12,,2024-02-15,2017-11-10,2017-11-17,ACTUAL,2024-02-15,2024-03-13,ACTUAL,,,,2024-02-15,2024-03-13,ACTUAL,2018-01-11,ACTUAL,2018-01-11,2024-02,2024-02-29,2023-02-06,ACTUAL,2023-02-06,2023-02-06,ACTUAL,2023-02-06,,INTERVENTIONAL,,"The safety run-in was intended to identify dose-limiting toxicity. No DLTs were observed in the safety run-in and the drug dose levels were not changed in the expansion cohort, therefore; results were for safety validation and expansion were combined.",KeyLargo: Pembrolizumab + Oxaliplatin + Capecitabine in Gastric Cancer,"A Single Arm, Phase II Study of Pembrolizumab, Oxaliplatin, and Capecitabine in the First Line Treatment of Patients With Gastro-esophageal Cancer.",COMPLETED,,PHASE2,36.0,ACTUAL,Duke University,,1.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,OTHER,,,,,,,2023,1.0
NCT04327934,,2018-10-17,2023-02-24,,2024-01-04,2020-03-27,2020-03-31,ACTUAL,2024-01-04,2024-02-02,ACTUAL,,,,2024-01-04,2024-02-02,ACTUAL,2017-12-01,ACTUAL,2017-12-01,2024-01,2024-01-31,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,"Baseline characteristics are presented for people that completed the study- which is defined as those that were allocated, began and completed the study.",Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome,Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome,TERMINATED,,EARLY_PHASE1,28.0,ACTUAL,Yale University,"Our primary limitation was stoppage due to Covid (our laboratory was forced to close). We also had a very challenging time recruiting subjects when we reopened after the three-month closure under new rules. Subjects who had been enrolled did not return, and new subjects were difficult to recruit. Thus, we were not able to complete all arms of the planned study. We were able to answer our primary questions regarding autonomic function in women with PCOS.",2.0,,Unble to complete all arms of the planned study due to Covid stoppage and difficulty with recruiting and getting enrolled participants to return post Covid.,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,OTHER,,,,,,,2022,0.0
NCT02007512,,2013-12-03,2017-09-21,,2024-08-02,2013-12-05,2013-12-10,ESTIMATED,2018-01-10,2018-02-06,ACTUAL,,,,2024-08-02,2024-08-27,ACTUAL,2013-12-16,ACTUAL,2013-12-16,2024-08,2024-08-31,2024-07-19,ACTUAL,2024-07-19,2016-09-23,ACTUAL,2016-09-23,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all the participants randomly assigned to double-blind study treatment.,Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer,"A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF EFFICACY AND SAFETY OF ENZALUTAMIDE IN COMBINATION WITH EXEMESTANE IN PATIENTS WITH ADVANCED BREAST CANCER THAT IS ESTROGEN OR PROGESTERONE RECEPTOR-POSITIVE AND HER2-NORMAL",COMPLETED,,PHASE2,247.0,ACTUAL,Pfizer,,2.0,,,f,,,,f,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,INDUSTRY,,,,,,,2024,1.0
NCT02264236,,2014-10-08,,,2021-06-08,2014-10-08,2014-10-15,ESTIMATED,,,,,,,2021-06-08,2021-06-10,ACTUAL,2015-10,ACTUAL,2015-10-31,2021-06,2021-06-30,2021-06,ACTUAL,2021-06-30,2021-06,ACTUAL,2021-06-30,,INTERVENTIONAL,,,Vaccination of Advanced-Stage Lung Cancer Patients,Vaccination of Advanced-Stage Lung Cancer Patients A Phase I/II Study of a Carbohydrate Mimotope Based Vaccine With MONTANIDETM ISA 51 VG ST Adjuvant,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Arkansas,,1.0,,Inability to enroll subjects under current iteration of the protocol,f,,,,t,,,,,,,,,,,,,2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,OTHER,,,,,,,2021,0.0
NCT03948464,,2019-05-07,,,2022-01-27,2019-05-13,2019-05-14,ACTUAL,,,,,,,2022-01-27,2022-02-10,ACTUAL,2019-12-06,ACTUAL,2019-12-06,2022-01,2022-01-31,2020-06-01,ACTUAL,2020-06-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,pRESTO,,Slow-Release Oral Morphine for the Treatment of Opioid Use Disorder,Repurposing Slow-Release Oral Morphine as a New Oral Alternative for the Treatment of Opioid Use Disorder,TERMINATED,,PHASE3,27.0,ACTUAL,BC Centre on Substance Use,,2.0,,Study unable to proceed per protocol due to COVID-19 precautions,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,OTHER,,,,,,,2020,0.0
NCT02555293,,2015-09-14,,,2021-10-28,2015-09-17,2015-09-21,ESTIMATED,,,,,,,2021-10-28,2021-11-01,ACTUAL,2016-02,,2016-02-29,2020-10,2020-10-31,2020-11-20,ACTUAL,2020-11-20,2020-11-20,ACTUAL,2020-11-20,,INTERVENTIONAL,ARROW,,Administration of Rifaximin to Improve Liver Regeneration and Outcome Following Major Liver Resection,Administration of Rifaximin to Improve Liver Regeneration and Outcome Following Major Liver Resection,TERMINATED,,PHASE2,96.0,ESTIMATED,RWTH Aachen University,,2.0,,Prematurely terminated due to organisational reasons,f,,,,,,,,,,,,,,,,,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,OTHER,,,,,,,2020,0.0
NCT05036135,,2021-08-16,,,2024-08-22,2021-08-30,2021-09-05,ACTUAL,,,,,,,2024-08-22,2024-08-23,ACTUAL,2021-12-02,ACTUAL,2021-12-02,2024-08,2024-08-31,2024-08-09,ACTUAL,2024-08-09,2024-08-09,ACTUAL,2024-08-09,,INTERVENTIONAL,IMPAHCT,,A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH),"IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients With Pulmonary Arterial Hypertension (PAH)",TERMINATED,,PHASE2/PHASE3,202.0,ACTUAL,Aerovate Therapeutics,,4.0,,"The IMPAHCT study demonstrated that while inhaled imatinib was well tolerated, it did not prove to be efficacious at any of the doses of AV-101 evaluated in the study.",f,,,,,t,f,,,t,,,,,,NO,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,INDUSTRY,,,,,,,2024,0.0
NCT02340221,,2015-01-13,2018-12-18,,2022-07-11,2015-01-13,2015-01-16,ESTIMATED,2019-01-22,2019-01-25,ACTUAL,,,,2022-07-11,2022-07-12,ACTUAL,2015-04-09,ACTUAL,2015-04-09,2022-07,2022-07-31,2021-06-29,ACTUAL,2021-06-29,2021-06-29,ACTUAL,2021-06-29,,INTERVENTIONAL,SANDPIPER,The intent-to-treat (ITT) population included all randomized participants regardless of whether they received any amount of study treatment.,A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy,"A Phase III, Double-Blind, Placebo-Controlled, Randomized Study of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy",TERMINATED,,PHASE3,631.0,ACTUAL,Hoffmann-La Roche,,2.0,,The Sponsor discontinued the manufacturing and development of taselisib due to modest clinical benefit and limited tolerability.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,INDUSTRY,,,,,,,2021,0.0
NCT05327855,,2021-12-22,,,2023-02-16,2022-04-12,2022-04-14,ACTUAL,,,,,,,2023-02-16,2023-02-21,ACTUAL,2022-09,ESTIMATED,2022-09-30,2023-02,2023-02-28,2024-11,ESTIMATED,2024-11-30,2024-08,ESTIMATED,2024-08-31,,INTERVENTIONAL,RESTORE,,Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI),"A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple-arm, Parallel-group, Adaptive Study to Investigate the Efficacy and Safety of OPL-0301 in Patients With Post-myocardial Infarction Left Ventricular Dysfunction (RESTORE)",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Valo Health, Inc.",,3.0,,"Withdrawn based on business decision, no participants enrolled",f,,,,t,t,f,,,,,,,,,,,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,INDUSTRY,,,,,,,2024,0.0
NCT03117530,,2016-11-30,,,2020-08-06,2017-04-17,2017-04-18,ACTUAL,,,,,,,2020-08-06,2020-08-10,ACTUAL,2017-04-11,ACTUAL,2017-04-11,2020-08,2020-08-31,2022-12,ESTIMATED,2022-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Measuring Brain Inflammation in Autism,"Targeting Microglial Activation for Treatment of Autism Spectrum Disorder (ASD): A Proof-of-Concept, Target-Engagement Study",SUSPENDED,,PHASE1,30.0,ESTIMATED,"University of California, Los Angeles",,1.0,,COVID,f,,,,t,t,f,,,t,,,,,,NO,IPD will not be shared,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,OTHER,,,,,,,2022,0.0
NCT03953456,,2019-05-15,,,2020-08-27,2019-05-15,2019-05-16,ACTUAL,,,,,,,2020-08-27,2020-08-31,ACTUAL,2019-08-16,ACTUAL,2019-08-16,2020-08,2020-08-31,2020-07-14,ACTUAL,2020-07-14,2020-03-11,ACTUAL,2020-03-11,,INTERVENTIONAL,,,Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL),"A Double-Blind, Placebo-Controlled, Cross-over Phase II Study to Evaluate the Effect of a 6-week Elafibranor (120mg) Treatment Administered Once Daily on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)",TERMINATED,,PHASE2,17.0,ACTUAL,Genfit,,2.0,,Continuation of the trial cannot serve a scientific purpose,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,INDUSTRY,,,,,,,2020,0.0
NCT03884972,,2019-03-19,,,2023-09-21,2019-03-19,2019-03-21,ACTUAL,,,,,,,2023-09-21,2023-09-25,ACTUAL,2019-06-18,ACTUAL,2019-06-18,2023-09,2023-09-30,2020-03-04,ESTIMATED,2020-03-04,2020-03-04,ACTUAL,2020-03-04,,INTERVENTIONAL,,,Trabectedin and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Resistant or Intolerant to a BTK Inhibitor,A Phase I/Ib Pilot Study of Combined Trabectedin and Venetoclax in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Resistant or Intolerant to a BTK Inhibitor,WITHDRAWN,,PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,Request by sponsor due to no enrollment of participants on study,,,,,f,t,f,,,f,,,,,,,,2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,OTHER,,,,,,,2020,0.0
NCT04843631,,2021-03-23,,,2022-03-23,2021-04-08,2021-04-13,ACTUAL,,,,,,,2022-03-23,2022-03-25,ACTUAL,2021-04-01,ACTUAL,2021-04-01,2022-03,2022-03-31,2021-12-08,ACTUAL,2021-12-08,2021-12-08,ACTUAL,2021-12-08,,INTERVENTIONAL,,,Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults,"Bioequivalence Randomised, Double-blind, 3-parallel -Group Phase I Study of BFI-751 Compared With EU-STELARA® and US-STELARA® in Healthy Adult Volunteers",COMPLETED,,PHASE1,216.0,ACTUAL,BioFactura Australia Pty Ltd.,,3.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,INDUSTRY,,,,,,,2021,1.0
NCT05258851,,2022-02-17,,,2024-06-12,2022-02-17,2022-02-28,ACTUAL,,,,,,,2024-06-12,2024-06-14,ACTUAL,2022-06-01,ACTUAL,2022-06-01,2024-06,2024-06-30,2024-01-28,ACTUAL,2024-01-28,2023-04-12,ACTUAL,2023-04-12,,INTERVENTIONAL,AVI-ICU,,Ceftazidime-Avibactam Use in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections,Ceftazidime-Avibactam Versus Colistin in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections (AVI-ICU): A Non-Inferiority Randomized Clinical Trial,TERMINATED,,PHASE3,29.0,ACTUAL,King Faisal Specialist Hospital & Research Center,,2.0,,Difficulties encountered in the recruitment process and slow enrollment. The study was not terminated due to any safety issues or concerns.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,OTHER,,,,,,,2024,0.0
NCT04039919,,2019-07-12,2021-05-21,,2021-05-21,2019-07-30,2019-07-31,ACTUAL,2021-05-21,2021-06-18,ACTUAL,,,,2021-05-21,2021-06-18,ACTUAL,2019-07-17,ACTUAL,2019-07-17,2021-05,2021-05-31,2020-05-22,ACTUAL,2020-05-22,2020-05-22,ACTUAL,2020-05-22,,INTERVENTIONAL,,Baseline Characteristics refer to Safety Set (SS) which consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.,"A Study to Test the Pharmacodynamic, Pharmacokinetic, Safety, and Tolerability of Padsevonil in Healthy Study Participants Receiving Either Ethanol or Cannabidiol","A Double-Blind, Placebo-Controlled, Randomized, Single-Center, Cross-Over Study to Investigate the Pharmacodynamic, Pharmacokinetic, Safety, and Tolerability Profiles of Padsevonil in Healthy Study Participants Receiving Either Ethanol or Cannabidiol",TERMINATED,,PHASE1,40.0,ACTUAL,UCB Pharma,The study was terminated because the decision was made to terminate the PSL development program in focal-onset seizures on 22 May 2020.,6.0,,"Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures",f,,,,f,f,f,,,,,,,,,NO,"Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.",2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,INDUSTRY,,,,,,,2020,0.0
NCT03739138,,2018-07-31,2022-01-19,,2022-01-19,2018-11-08,2018-11-13,ACTUAL,2022-01-19,2022-02-28,ACTUAL,,,,2022-01-19,2022-02-28,ACTUAL,2018-12-18,ACTUAL,2018-12-18,2022-01,2022-01-31,2021-03-02,ACTUAL,2021-03-02,2021-03-02,ACTUAL,2021-03-02,,INTERVENTIONAL,,,Intratumoral/Intralesional Administration of MK-4621/JetPEI™ With or Without Pembrolizumab in Participants With Advanced/Metastatic or Recurrent Solid Tumors (MK-4621-002),"A Phase 1/1b, Open-label Clinical Study of Intratumoral/Intralesional Administration of MK-4621/JetPEI as Monotherapy or in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic or Recurrent Solid Tumors",TERMINATED,,PHASE1,30.0,ACTUAL,Merck Sharp & Dohme LLC,,3.0,,Business Reasons,f,,,,f,t,f,,,t,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 17:55:58.691213,2024-10-16 17:55:58.691213,INDUSTRY,,,,,,,2021,0.0
NCT05622591,,2022-11-08,,,2024-08-05,2022-11-14,2022-11-18,ACTUAL,,,,,,,2024-08-05,2024-08-07,ACTUAL,2024-06-07,ACTUAL,2024-06-07,2024-08,2024-08-31,2024-06-07,ACTUAL,2024-06-07,2024-06-07,ACTUAL,2024-06-07,,INTERVENTIONAL,Pediatric AML,,ELU001 in Pediatric Subjects Who Have Relapsed and/or Refractory CBFA2T3-GLIS2-positive AML,Dose Escalation Study to Evaluate the Safety and Tolerability of ELU001 in Pediatric Patients Who Have Relapsed and/or Refractory CBFA2T3::GLIS2 Positive Acute Myeloid Leukemia,WITHDRAWN,,PHASE1,0.0,ACTUAL,Elucida Oncology,,1.0,,Lack of Funding - no safety issue with Drug; Company Permanently Closed,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,INDUSTRY,,,,,,,2024,0.0
NCT05035095,,2021-08-30,,2024-03-14,2024-07-05,2021-08-30,2021-09-05,ACTUAL,,,,,2024-03-15,ACTUAL,2024-07-05,2024-07-08,ACTUAL,2021-09-13,ACTUAL,2021-09-13,2024-07,2024-07-31,2023-05-12,ACTUAL,2023-05-12,2023-03-24,ACTUAL,2023-03-24,,INTERVENTIONAL,OASIS 1,,Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1),Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1),COMPLETED,,PHASE3,667.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,INDUSTRY,,,,,,,2023,1.0
NCT04270487,,2019-09-27,,,2020-11-16,2020-02-13,2020-02-17,ACTUAL,,,,,,,2020-11-16,2020-11-17,ACTUAL,2018-07-26,ACTUAL,2018-07-26,2020-11,2020-11-30,2020-07-06,ACTUAL,2020-07-06,2020-05-04,ACTUAL,2020-05-04,,INTERVENTIONAL,DOMINO,,The DOMINO Trial: Diet Or Medication in Irritable Bowel syNdrOme,A Randomized Controlled Trial to Evaluate the Short-term Efficacy and Long-term Health Economic Impact of a Dietary Intervention Compared to Pharmacotherapy With a Musculotropic Spasmolytic Agent for Newly Diagnosed or Newly Treated Irritable Bowel Syndrome in Primary Care,COMPLETED,,PHASE4,472.0,ACTUAL,Universitaire Ziekenhuizen KU Leuven,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,OTHER,,,,,,,2020,1.0
NCT02716688,,2016-02-11,,,2023-09-20,2016-03-22,2016-03-23,ESTIMATED,,,,,,,2023-09-20,2023-09-22,ACTUAL,2016-01,,2016-01-31,2023-09,2023-09-30,2020-12,ESTIMATED,2020-12-31,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,S-1 and Radiotherapy for Elderly Esophageal Cancer Patients,A Phase Ⅱ Study of S-1 With Concurrent Radiotherapy in Elderly Esophageal Cancer Patients,WITHDRAWN,,PHASE2,0.0,ACTUAL,Zhejiang Provincial People's Hospital,,1.0,,No patients enrolled.,f,,,,f,,,,,,,,,,,,,2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,OTHER,,,,,,,2020,0.0
NCT05157360,,2021-10-28,2024-06-11,,2024-07-02,2021-12-13,2021-12-15,ACTUAL,2024-07-02,2024-07-24,ACTUAL,,,,2024-07-02,2024-07-24,ACTUAL,2021-09-10,ACTUAL,2021-09-10,2024-07,2024-07-31,2023-05-16,ACTUAL,2023-05-16,2023-05-16,ACTUAL,2023-05-16,,INTERVENTIONAL,,,HAT for the Treatment of Sepsis Associated With NASTI,"Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis Associated With Acute Necrotizing Soft Tissue Infections, The NASTI HAT Trial",TERMINATED,,PHASE1/PHASE2,10.0,ACTUAL,"Ascension Via Christi Hospitals Wichita, Inc.","Due to the small number of participants enrolled, the findings are observational only.",2.0,,slow recruitment and not anticipated to meet recruitment numbers,f,,,,,t,f,,,t,,,,,,NO,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,OTHER,,,,,,,2023,0.0
NCT03485092,,2018-03-19,,,2020-09-16,2018-03-26,2018-04-02,ACTUAL,,,,,,,2020-09-16,2020-09-18,ACTUAL,2018-03-16,ACTUAL,2018-03-16,2020-09,2020-09-30,2020-03-28,ACTUAL,2020-03-28,2020-03-28,ACTUAL,2020-03-28,,INTERVENTIONAL,SUGAR-DM-HF,,"Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects","Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects in Patients With Diabetes Mellitus (or Pre-diabetes) and Heart Failure (SUGAR-DM-HF)",COMPLETED,,PHASE4,105.0,ACTUAL,NHS Greater Glasgow and Clyde,,2.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,OTHER,,,,,,,2020,1.0
NCT04991740,,2021-08-02,,,2023-03-22,2021-08-02,2021-08-05,ACTUAL,,,,,,,2023-03-22,2023-03-24,ACTUAL,2021-10-24,ACTUAL,2021-10-24,2023-03,2023-03-31,2023-02-09,ACTUAL,2023-02-09,2023-02-09,ACTUAL,2023-02-09,,INTERVENTIONAL,,,A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors,"A Phase 1 Study of JNJ-78306358, a T Cell Redirecting Bispecific Antibody Targeting HLA-G for Advanced Stage Solid Tumors",COMPLETED,,PHASE1,39.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,,f,,,,f,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,INDUSTRY,,,,,,,2023,0.0
NCT03421756,,2018-01-29,,,2022-06-21,2018-01-29,2018-02-05,ACTUAL,,,,,,,2022-06-21,2022-06-28,ACTUAL,2018-03-29,ACTUAL,2018-03-29,2022-06,2022-06-30,2022-05-15,ACTUAL,2022-05-15,2018-09-15,ACTUAL,2018-09-15,,INTERVENTIONAL,,,Stem Cell Transplant in Patients With Severe Sickle Cell Disease,A Pilot Study Evaluating the Efficacy of Non-Myeloablative Matched Related Donor Peripheral Blood Stem Cell Transplant in Patients With Severe Sickle Cell Disease,TERMINATED,,EARLY_PHASE1,1.0,ACTUAL,University of Pittsburgh,,1.0,,Trial terminated due to low rate of enrollment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,OTHER,,,,,,,2022,0.0
NCT04740931,,2021-02-03,2023-11-22,2023-06-02,2024-07-10,2021-02-03,2021-02-05,ACTUAL,2023-12-20,2024-01-18,ACTUAL,,2024-01-18,ACTUAL,2024-07-10,2024-08-06,ACTUAL,2021-03-02,ACTUAL,2021-03-02,2024-07,2024-07-31,2023-07-12,ACTUAL,2023-07-12,2022-08-09,ACTUAL,2022-08-09,,INTERVENTIONAL,COMINO,"ITT Population: All global participants who were randomized in the study, according to the assigned treatment.",A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion,"A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion",COMPLETED,,PHASE3,729.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing",2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,INDUSTRY,,,,,,,2023,1.0
NCT02677181,,2015-12-01,,,2022-05-23,2016-02-04,2016-02-09,ESTIMATED,,,,,,,2022-05-23,2022-05-24,ACTUAL,2016-01,ACTUAL,2016-01-31,2022-05,2022-05-31,2022-04,ACTUAL,2022-04-30,2020-01,ACTUAL,2020-01-31,,INTERVENTIONAL,,,Efficacy and Safety Study of ATG for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT,Prospective Study of Combined ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT,COMPLETED,,PHASE4,100.0,ACTUAL,Chinese PLA General Hospital,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,OTHER,,,,,,,2022,1.0
NCT04724837,,2021-01-25,2024-05-16,,2024-07-05,2021-01-25,2021-01-26,ACTUAL,2024-07-05,2024-07-30,ACTUAL,,,,2024-07-05,2024-07-30,ACTUAL,2021-04-28,ACTUAL,2021-04-28,2024-07,2024-07-31,2023-06-01,ACTUAL,2023-06-01,2023-06-01,ACTUAL,2023-06-01,,INTERVENTIONAL,ZENITH-CKD,The full analysis set included all participants who were randomised and received any study intervention.,Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial),"A Phase 2b Multicentre, Randomised, Double-Blind, Active-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozin in Patients With Chronic Kidney Disease With Estimated Glomerular Filtration Rate (eGFR) ≥ 20 mL/Min/1.73 m^2",COMPLETED,,PHASE2,542.0,ACTUAL,AstraZeneca,No multiple testing correction was considered in this early phase study.,3.0,,,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,INDUSTRY,,,,,,,2023,1.0
NCT04900038,,2021-05-19,2023-11-21,,2023-11-21,2021-05-19,2021-05-25,ACTUAL,2023-11-21,2023-12-14,ACTUAL,,,,2023-11-21,2023-12-14,ACTUAL,2021-08-18,ACTUAL,2021-08-18,2023-11,2023-11-30,2023-05-11,ACTUAL,2023-05-11,2022-11-22,ACTUAL,2022-11-22,,INTERVENTIONAL,DYNAMIC,,A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults,"A Phase IIb, Randomized, Double-blind, Parallel-group Study to Assess the Efficacy, Safety, Tolerability, and Resistance Profile of GSK3640254 in Combination With Dolutegravir Compared to Dolutegravir Plus Lamivudine in HIV-1 Infected, Treatment-naïve Adults",TERMINATED,,PHASE2,85.0,ACTUAL,ViiV Healthcare,,4.0,,Company decision to stop compound development. The decision was not based on any safety or efficacy concerns. It reflected the company strategy for portfolio progression.,f,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,INDUSTRY,,,,,,,2023,0.0
NCT04209530,,2019-12-11,2021-07-23,,2021-09-10,2019-12-20,2019-12-24,ACTUAL,2021-09-10,2021-10-07,ACTUAL,,,,2021-09-10,2021-10-07,ACTUAL,2019-11-20,ACTUAL,2019-11-20,2020-11,2020-11-30,2020-10-05,ACTUAL,2020-10-05,2020-07-23,ACTUAL,2020-07-23,,INTERVENTIONAL,,,Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Women,"A Phase 2a, Open Label Study to Assess the Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Females Using Photonumeric Scales, Magnetic Resonance Imaging and Histopathology",TERMINATED,,PHASE2,7.0,ACTUAL,Endo Pharmaceuticals,,1.0,,Study terminated due to COVID-19 impact,f,,,,f,t,f,,,,,,,,,YES,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,INDUSTRY,,,,,,,2020,0.0
NCT05423106,,2022-06-06,,,2023-06-07,2022-06-14,2022-06-21,ACTUAL,,,,,,,2023-06-07,2023-06-08,ACTUAL,2022-07-04,ACTUAL,2022-07-04,2023-06,2023-06-30,2023-03-20,ACTUAL,2023-03-20,2023-03-14,ACTUAL,2023-03-14,,INTERVENTIONAL,,,A Single and Multiple Ascending Dose Study of JNJ-64457744,"A Phase 1, Blinded, Randomized, Placebo-controlled, First-in-human Study of Orally Administered JNJ-64457744 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Ascending Doses",TERMINATED,,PHASE1,60.0,ACTUAL,"Janssen Research & Development, LLC",,7.0,,"Strategic business decision, not due to safety concerns",f,,,,f,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 22:47:23.591052,2024-10-15 22:47:23.591052,INDUSTRY,,,,,,,2023,0.0
NCT03081039,,2017-02-09,,,2018-02-15,2017-03-08,2017-03-15,ACTUAL,,,,,,,2018-02-15,2018-02-19,ACTUAL,2017-08-21,ACTUAL,2017-08-21,2017-03,2017-03-31,2022-12-31,ESTIMATED,2022-12-31,2022-04-28,ESTIMATED,2022-04-28,,INTERVENTIONAL,,,A Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablation Intra-Hepatic Cholangiocarcinoma,"A Phase III, Multicenter, Open-Label, Randomized Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablated Intra-Hepatic Cholangiocarcinoma",WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Louisville,,2.0,,Competing study,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,OTHER,,,,,,,2022,0.0
NCT04754334,,2021-02-08,,,2023-02-07,2021-02-09,2021-02-15,ACTUAL,,,,,,,2023-02-07,2023-02-09,ACTUAL,2021-03-16,ACTUAL,2021-03-16,2023-02,2023-02-28,2023-01-13,ACTUAL,2023-01-13,2023-01-13,ACTUAL,2023-01-13,,INTERVENTIONAL,,,A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus,"A Double-Blind, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in T2DM Subjects With Inadequate Glycemic Control on Diet Control Only or on Diet Control and Metformin Monotherapy.",TERMINATED,,PHASE3,346.0,ACTUAL,"Oramed, Ltd.",,2.0,,The ORA-D-013-2 protocol was terminated based on the primary results analyzed at week 26 in the ORA-D-013-1 protocol.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,INDUSTRY,,,,,,,2023,0.0
NCT04198649,,2019-12-12,,,2024-08-16,2019-12-12,2019-12-13,ACTUAL,,,,,,,2024-08-16,2024-08-20,ACTUAL,2021-11-02,ACTUAL,2021-11-02,2024-08,2024-08-31,2023-11-02,ACTUAL,2023-11-02,2023-11-02,ACTUAL,2023-11-02,,INTERVENTIONAL,AZITHROPARO,,Effect of Azithromycin on Failure Proportion of Severe Periodontitis Non-surgical Treatment,Effect of Azithromycin on Failure Proportion of Severe Periodontitis Non-surgical Treatment,TERMINATED,,PHASE3,6.0,ACTUAL,"University Hospital, Strasbourg, France",,2.0,,not enough patients,f,,,,f,f,f,,,,,,,,,,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,OTHER,,,,,,,2023,0.0
NCT04912115,,2021-05-25,,,2023-11-15,2021-05-27,2021-06-03,ACTUAL,,,,,,,2023-11-15,2023-11-18,ACTUAL,2021-10-05,ACTUAL,2021-10-05,2023-11,2023-11-30,2024-03-30,ESTIMATED,2024-03-30,2023-12-30,ESTIMATED,2023-12-30,,INTERVENTIONAL,,,"Randomized, Double-Blind, Active Placebo-Controlled Study of Ketamine to Treat Levodopa-Induced Dyskinesia","A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo- Controlled Trial of Sub-Anesthetic Intravenous Infusion of Ketamine to Treat Levodopa- Induced Dyskinesia in Subjects With Parkinson's Disease",SUSPENDED,,PHASE2,30.0,ACTUAL,PharmaTher Inc.,,2.0,,Seeking Pivotal study initiation,f,,,,,t,f,,,,,,,,,,,2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,INDUSTRY,,,,,,,2024,0.0
NCT02356991,,2015-01-16,,,2019-10-31,2015-02-02,2015-02-06,ESTIMATED,,,,,,,2019-10-31,2019-11-04,ACTUAL,2014-12,ACTUAL,2014-12-31,2019-10,2019-10-31,2020-06,ESTIMATED,2020-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,A Study of Famitinib in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC),"A Randomized,Double-Blind, Placebo-Controlled, Multicenter, Phase II Study of Famitinib in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)",SUSPENDED,,PHASE2,137.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,2.0,,sponsor decides to suspend this trial,f,,,,f,,,,,,,,,,,,,2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,INDUSTRY,,,,,,,2020,0.0
NCT04568031,,2020-08-21,2022-08-16,,2023-08-04,2020-09-25,2020-09-29,ACTUAL,2023-08-04,2024-03-01,ACTUAL,,,,2023-08-04,2024-03-01,ACTUAL,2020-08-23,ACTUAL,2020-08-23,2023-07,2023-07-31,2021-11-22,ACTUAL,2021-11-22,2021-11-22,ACTUAL,2021-11-22,,INTERVENTIONAL,,The Total vaccinated analysis set (TVS) included all participants who received at least 1 dose of study vaccination.,Study of AZD1222 for the Prevention of COVID-19 in Japan,"A Phase I/II Randomized, Double-blind, Placebo-controlled Multicentre Study in Participants Aged 18 Years or Older to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19",COMPLETED,,PHASE1/PHASE2,256.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,INDUSTRY,,,,,,,2021,1.0
NCT05109702,,2021-10-27,2023-08-06,2023-05-05,2023-10-19,2021-10-27,2021-11-05,ACTUAL,2023-10-19,2023-10-23,ACTUAL,,2023-10-23,ACTUAL,2023-10-19,2023-10-23,ACTUAL,2021-11-18,ACTUAL,2021-11-18,2023-10,2023-10-31,2022-05-06,ACTUAL,2022-05-06,2022-05-06,ACTUAL,2022-05-06,,INTERVENTIONAL,VELOS-3,Intent-to-Treat (ITT) Population included all randomized participants.,A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye,"A Phase 3, Multicenter, Randomized, Double Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution 0.25% Compared to Placebo in Subjects With Dry Eye",COMPLETED,,PHASE3,260.0,ACTUAL,"HanAll BioPharma Co., Ltd.",,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,INDUSTRY,,,,,,,2022,1.0
NCT03808935,,2019-01-11,,,2020-09-09,2019-01-15,2019-01-18,ACTUAL,,,,,,,2020-09-09,2020-09-11,ACTUAL,2019-01-10,ACTUAL,2019-01-10,2020-09,2020-09-30,2020-03-15,ACTUAL,2020-03-15,2020-03-15,ACTUAL,2020-03-15,,INTERVENTIONAL,CERES,,Cannabis Extract in Refractory Epilepsy Study,"A Double-Blind, Placebo-Controlled, Parallel-Group Study of Cannabidiol Plus Tetrahydrocannabinol (CBD+THC) Given as Adjunctive Therapy in Patients With Refractory Seizures",TERMINATED,,PHASE3,17.0,ACTUAL,The Epilepsy Research Program of the Ontario Brain Institute,,2.0,,Participants are no longer being examined or receiving intervention.,f,,,,f,f,f,,,,,,,,,,,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,OTHER,,,,,,,2020,0.0
NCT03152786,,2017-05-09,,,2023-07-13,2017-05-11,2017-05-15,ACTUAL,,,,,,,2023-07-13,2023-07-17,ACTUAL,2019-01-15,ACTUAL,2019-01-15,2023-07,2023-07-31,2023-02-28,ACTUAL,2023-02-28,2021-06-15,ACTUAL,2021-06-15,,INTERVENTIONAL,,,Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery,Evaluating the Effect of ADRB2 Blockers on PKA/BAD/CREB Signaling in Patients Undergoing Prostatectomy,TERMINATED,,PHASE2,46.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,PIs not interested in continuing with the trial.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,OTHER,,,,,,,2023,0.0
NCT03362515,,2017-11-28,2023-06-07,,2023-08-04,2017-12-04,2017-12-05,ACTUAL,2023-08-04,2023-08-30,ACTUAL,,,,2023-08-04,2023-08-30,ACTUAL,2017-12-01,ACTUAL,2017-12-01,2023-08,2023-08-31,2022-04-14,ACTUAL,2022-04-14,2022-04-14,ACTUAL,2022-04-14,,INTERVENTIONAL,,,Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide,Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide,TERMINATED,,PHASE2,18.0,ACTUAL,Thomas Jefferson University,,2.0,,The study was terminated prematurely due to low enrollment numbers and the development of better drugs to treat polyps (ie. Biologics) which were not available when the study began.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,OTHER,,,,,,,2022,0.0
NCT00508274,,2007-07-26,2009-07-24,,2021-08-26,2007-07-26,2007-07-27,ESTIMATED,2009-07-24,2009-09-03,ESTIMATED,,,,2021-08-26,2021-09-21,ACTUAL,2007-07-18,ACTUAL,2007-07-18,2021-08,2021-08-31,2020-07-01,ACTUAL,2020-07-01,2015-12-02,ACTUAL,2015-12-02,,INTERVENTIONAL,,,Lapatinib +Capecitabine Treatment for Advanced Metastatic Breast Cancer in Women From China,An Open-Label Multicenter Study Administering Lapatinib and Capecitabine (Xeloda) in Women With Advanced or Metastatic Breast Cancer,TERMINATED,,PHASE3,52.0,ACTUAL,Novartis,Data collection post 1-Jul-2019 was not reportable due to local regulations in China.,1.0,,Primary analysis was completed in 2015 and data collection post 1-Jul-2019 was not reportable due to local regulations in China.,f,,,,f,f,f,,,,,,,,http://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,INDUSTRY,,,,,,,2020,0.0
NCT02658916,,2016-01-13,,,2020-05-14,2016-01-19,2016-01-20,ESTIMATED,,,,,,,2020-05-14,2020-05-18,ACTUAL,2016-02-22,ACTUAL,2016-02-22,2020-05,2020-05-31,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,,Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003,"A Multicenter, Open-Label, Long-Term Treatment Study of Intravenously Administered BIIB092 in Patients With Progressive Supranuclear Palsy Who Participated in Study CN002003",TERMINATED,,PHASE1,47.0,ACTUAL,Biogen,,4.0,,251PP301(NCT03068468) primary endpoint was not met;further development of Gosuranemab BIIB092 in progressive supranuclear palsy will not be pursued.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,INDUSTRY,,,,,,,2020,0.0
NCT04582669,,2020-09-29,2023-08-29,,2023-10-16,2020-10-05,2020-10-09,ACTUAL,2023-10-16,2023-11-13,ACTUAL,,,,2023-10-16,2023-11-13,ACTUAL,2022-01-24,ACTUAL,2022-01-24,2023-10,2023-10-31,2022-10-12,ACTUAL,2022-10-12,2022-10-12,ACTUAL,2022-10-12,,INTERVENTIONAL,,,Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa,Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa,TERMINATED,,PHASE4,11.0,ACTUAL,Montefiore Medical Center,,4.0,,This study was administratively closed.,f,,,,,t,f,,,t,,,,,,,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER,,,,,,,2022,0.0
NCT03670069,,2018-09-12,,,2024-05-06,2018-09-12,2018-09-13,ACTUAL,,,,,,,2024-05-06,2024-05-08,ACTUAL,2019-09-30,ACTUAL,2019-09-30,2024-05,2024-05-31,2024-05-06,ACTUAL,2024-05-06,2023-03-04,ACTUAL,2023-03-04,,INTERVENTIONAL,,,Itacitinib in Treating Patients With Refractory Metastatic/Advanced Sarcomas,A Pilot Study Examining the Impact of the Jak1 Inhibitor Itacitinib on the Sarcoma Tumor Immune Microenvironment,TERMINATED,,PHASE1,27.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,"The study was terminated early with 27 out of 28 planned subjects enrolled. This decision was multifactorial, including slow enrollment in the last remaining cohort and a lack of evidence of clinical benefit.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,OTHER,,,,,,,2024,0.0
NCT04992273,,2021-08-03,2023-01-11,,2023-03-03,2021-08-03,2021-08-05,ACTUAL,2023-03-03,2023-03-06,ACTUAL,,,,2023-03-03,2023-03-06,ACTUAL,2021-09-13,ACTUAL,2021-09-13,2023-03,2023-03-31,2022-06-01,ACTUAL,2022-06-01,2022-06-01,ACTUAL,2022-06-01,,INTERVENTIONAL,,,COVID-19 Administration of Single-Dose Subcutaneous Anti- Spike(s) SARS-CoV-2 Monoclonal Antibodies Casirivimab and Imdevimab in High-Risk Pediatric Participants Under 12 Years of Age,"A Phase 2A, Open-Label Study Assessing Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Single-Dose Subcutaneous Anti- Spike(s) SARS-COV-2 Monoclonal Antibodies (Casirivimab and Imdevimab) in High-Risk Pediatric Subjects Under 12 Years of Age",TERMINATED,,PHASE2,7.0,ACTUAL,Regeneron Pharmaceuticals,The study was terminated early due to emerging SARS-CoV-2 variants impacting susceptibility to the study drug. The early termination was not due to safety findings.,4.0,,Emerging SARS-CoV-2 variants impacting susceptibility to study drug,t,,,,t,t,f,,,,,,"When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.",Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf,https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-14 21:39:23.483336,2024-10-14 21:39:23.483336,INDUSTRY,,NCT04617535,NO_LONGER_AVAILABLE,,,,2022,0.0
NCT00304070,,2006-03-15,2016-10-21,,2024-02-26,2006-03-15,2006-03-17,ESTIMATED,2017-05-11,2017-06-12,ACTUAL,,,,2024-02-26,2024-02-28,ACTUAL,2007-05-03,ACTUAL,2007-05-03,2024-02,2024-02-29,2023-06-30,ACTUAL,2023-06-30,2015-12-31,ACTUAL,2015-12-31,,INTERVENTIONAL,,,Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor,Treatment of Adrenocortical Tumors With Surgery Plus Lymph Node Dissection and Multiagent Chemotherapy: A Groupwide Phase III Study,COMPLETED,,PHASE3,78.0,ACTUAL,Children's Oncology Group,,3.0,,,f,,,,,,,,,,,,,,,YES,Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive,2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,NETWORK,,,,,,,2023,1.0
NCT04109950,,2019-09-27,,,2024-06-25,2019-09-30,2019-10-01,ACTUAL,,,,,,,2024-06-25,2024-06-26,ACTUAL,2019-10-04,ACTUAL,2019-10-04,2024-06,2024-06-30,2023-11-09,ACTUAL,2023-11-09,2023-11-09,ACTUAL,2023-11-09,,INTERVENTIONAL,,,A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia,An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia,TERMINATED,,PHASE3,452.0,ACTUAL,"Otsuka Pharmaceutical Development & Commercialization, Inc.",,1.0,,"Study terminated early, main goals achieved",f,,,,t,t,f,,,,,,"Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.",Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/,http://clinical-trials.otsuka.com,YES,Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.,2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,INDUSTRY,,,,,,,2023,0.0
NCT04840784,,2021-03-05,,,2023-10-09,2021-04-09,2021-04-12,ACTUAL,,,,,,,2023-10-09,2023-10-11,ACTUAL,2021-06-29,ACTUAL,2021-06-29,2023-05,2023-05-31,2023-05-02,ACTUAL,2023-05-02,2023-05-02,ACTUAL,2023-05-02,,INTERVENTIONAL,,,"First-in Human (FIH) Trial of ETH-155008 in Subjects With B-NHL, CLL/SLL and AML","A Phase 1a/1b Dose Escalation and Dose Expansion, First-in-human, Open-Labeled Study of ETH-155008 in Subjects With Relapsed or Refractory B-cell NHL, CLL/SLL and AML",TERMINATED,,PHASE1,9.0,ACTUAL,"Shengke Pharmaceuticals (Jiangsu) Limited, China",,1.0,,The reasons for early termination is due to slow recruitment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,INDUSTRY,,,,,,,2023,0.0
NCT05976334,,2023-07-28,,,2024-08-02,2023-07-28,2023-08-04,ACTUAL,,,,,,,2024-08-02,2024-08-06,ACTUAL,2023-11-14,ACTUAL,2023-11-14,2024-08,2024-08-31,2024-07-16,ACTUAL,2024-07-16,2024-06-21,ACTUAL,2024-06-21,,INTERVENTIONAL,,,"An Absorption, Distribution, Metabolism, Excretion (ADME) Study of [14C]Subasumstat in Adults With Advanced or Metastatic Solid Tumors","A Phase 1 Study to Assess Mass Balance, Pharmacokinetics, and Metabolism of [14C]Subasumstat in Patients With Advanced or Metastatic Solid Tumors",TERMINATED,,PHASE1,3.0,ACTUAL,Takeda,,1.0,,Business reasons,f,,,,,f,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,INDUSTRY,,,,,,,2024,0.0
NCT03194646,,2017-06-20,2021-06-21,2020-03-17,2024-08-02,2017-06-20,2017-06-21,ACTUAL,2021-08-04,2021-08-26,ACTUAL,2021-08-04,2021-08-26,ACTUAL,2024-08-02,2024-08-27,ACTUAL,2017-06-30,ACTUAL,2017-06-30,2024-08,2024-08-31,2024-07-11,ACTUAL,2024-07-11,2019-05-10,ACTUAL,2019-05-10,,INTERVENTIONAL,ASTEROID 6,"Participants in Full analysis set (FAS) was analyzed. The FAS consisted of all randomized subjects, excluding randomized subjects who did not start treatment Period 1 (never received study drug) due to the study being temporarily paused, including 1264 participants.",Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids,"An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Versus Standard of Care",TERMINATED,,PHASE3,1272.0,ACTUAL,Bayer,Only two patients are in safety follow up due to local requirement.,4.0,,"Due to a change in the development program, the study was closed prematurely.",f,,,,f,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,INDUSTRY,,,,,,,2024,0.0
NCT02635386,,2015-12-15,2020-12-08,,2021-01-09,2015-12-15,2015-12-18,ESTIMATED,2021-01-09,2021-01-29,ACTUAL,,,,2021-01-09,2021-01-29,ACTUAL,2016-03-22,ACTUAL,2016-03-22,2021-01,2021-01-31,2020-10-09,ACTUAL,2020-10-09,2020-07-22,ACTUAL,2020-07-22,,INTERVENTIONAL,,All participants were started on medicine,"EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS)","Comparison of Dapagliflozin (DAPA) and Once-weekly Exenatide (EQW), Co-administered or Alone, DAPA/ Glucophage (DAPA/MET ER) and Phentermine/Topiramate (PHEN/TPM) ER on Metabolic Profiles and Body Composition in Obese PCOS Women",COMPLETED,,PHASE3,119.0,ACTUAL,Woman's,"One limitation of this study is the lack of a placebo only arm. As we were interested in the effects of different treatment regimens for obese women with PCOS, this study was designed to provide all patients with drug therapy. Limitations of the present study further include the absence of gold-standard measures of insulin sensitivity ; instead we used the OGTT using established surrogate measures.. Last, serial assessments were over only 24 weeks of treatment.",5.0,,,f,,,,t,,,,,,,,,,,NO,Individual data will only be shared with participant,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER,,,,,,,2020,1.0
NCT04706793,,2021-01-11,2023-08-02,,2023-09-22,2021-01-11,2021-01-13,ACTUAL,2023-09-22,2023-10-16,ACTUAL,,,,2023-09-22,2023-10-16,ACTUAL,2020-12-25,ACTUAL,2020-12-25,2023-09,2023-09-30,2022-08-03,ACTUAL,2022-08-03,2022-08-03,ACTUAL,2022-08-03,,INTERVENTIONAL,,Full Analysis Set: All randomized participants who received at least 1 dose of study intervention.,Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN),"A Phase 3, Double-Blind, Placebo-Controlled, 40-Week Extension Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis",COMPLETED,,PHASE3,42.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,t,f,,,t,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,INDUSTRY,,,,,,,2022,0.0
NCT03014804,,2016-11-30,,,2020-07-22,2017-01-05,2017-01-09,ESTIMATED,,,,,,,2020-07-22,2020-07-24,ACTUAL,2019-12-01,ESTIMATED,2019-12-01,2019-08,2019-08-31,2022-12-01,ESTIMATED,2022-12-01,2020-12-01,ESTIMATED,2020-12-01,,INTERVENTIONAL,,,Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen Vaccine and Nivolumab in Treating Patients With Recurrent Glioblastoma,A Phase II Clinical Trial Evaluating Combination Therapy Using DCVax-L (Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen) and Nivolumab (an Anti-PD-1 Antibody) for Subjects With Recurrent Glioblastoma Multiforme,WITHDRAWN,,PHASE2,0.0,ACTUAL,Jonsson Comprehensive Cancer Center,,2.0,,Final contract negotiations,f,,,,t,t,f,,,,,,,,,,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,OTHER,,,,,,,2022,0.0
NCT05491447,,2022-08-03,,,2024-04-17,2022-08-04,2022-08-08,ACTUAL,,,,,,,2024-04-17,2024-04-18,ACTUAL,2023-01-08,ACTUAL,2023-01-08,2024-04,2024-04-30,2024-04-15,ACTUAL,2024-04-15,2023-12-30,ACTUAL,2023-12-30,,INTERVENTIONAL,,,A Clinical Trial of BMX-010 in Adult Subjects With Atopic Dermatitis,"A Phase 2 Clinical Trial to Evaluate the Safety, Clinical Effects, and Systemic Exposure of a Topical Application of BMX-010 Ointment in Adult Subjects With Atopic Dermatitis",TERMINATED,,PHASE2,103.0,ACTUAL,"BioMimetix JV, LLC",,3.0,,Funding constraints,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 08:47:26.514176,2024-10-16 08:47:26.514176,INDUSTRY,,,,,,,2024,0.0
NCT03634839,,2018-08-13,2024-06-13,,2024-07-15,2018-08-13,2018-08-17,ACTUAL,2024-07-15,2024-08-09,ACTUAL,,,,2024-07-15,2024-08-09,ACTUAL,2022-11-07,ACTUAL,2022-11-07,2024-07,2024-07-31,2023-07-20,ACTUAL,2023-07-20,2023-06-16,ACTUAL,2023-06-16,,INTERVENTIONAL,,,Effects of E-cigarette Flavors on Youth TCORS 2.0,Effects of E-cigarette Flavors on Youth,COMPLETED,,PHASE1,42.0,ACTUAL,Yale University,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER,,,,,,,2023,1.0
NCT05309512,,2022-03-09,,,2024-04-29,2022-03-25,2022-04-04,ACTUAL,,,,,,,2024-04-29,2024-05-01,ACTUAL,2022-05-27,ACTUAL,2022-05-27,2023-07,2023-07-31,2023-11-14,ACTUAL,2023-11-14,2023-11-14,ACTUAL,2023-11-14,,INTERVENTIONAL,,,Clinical Study of KN052 in Chinese Subjects With Advanced Solid Tumors,"A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of KN052 in Chinese Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,15.0,ACTUAL,"Jiangsu Alphamab Biopharmaceuticals Co., Ltd",,1.0,,"Based on the differentiated R\&D strategy, the sponsor applies for the termination of the project.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,INDUSTRY,,,,,,,2023,0.0
NCT04105062,,2019-09-20,,,2021-12-01,2019-09-24,2019-09-26,ACTUAL,,,,,,,2021-12-01,2021-12-09,ACTUAL,2021-12-31,ESTIMATED,2021-12-31,2021-12,2021-12-31,2023-12-31,ESTIMATED,2023-12-31,2023-12-31,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,"LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery","Evaluation of LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Washington University School of Medicine,,4.0,,One of the investigators is leaving the University.,f,,,,t,t,t,,,f,,,,,,NO,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER,,,,,,,2023,0.0
NCT03746522,,2018-11-15,2023-05-18,,2023-11-09,2018-11-15,2018-11-19,ACTUAL,2023-11-09,2023-12-01,ACTUAL,,,,2023-11-09,2023-12-01,ACTUAL,2018-11-23,ACTUAL,2018-11-23,2023-11,2023-11-30,2021-03-08,ACTUAL,2021-03-08,2020-11-16,ACTUAL,2020-11-16,,INTERVENTIONAL,,Safety Analysis Set defined as participants who received at least 1 dose of study drug (placebo or setmelanotide).,"Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe Obesity","A Phase 3 Trial of Setmelanotide (RM-493), a Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Patients With Moderate to Severe Obesity",COMPLETED,,PHASE3,52.0,ACTUAL,"Rhythm Pharmaceuticals, Inc.",,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,INDUSTRY,,,,,,,2021,1.0
NCT03235869,,2017-07-27,,,2018-03-13,2017-07-27,2017-08-01,ACTUAL,,,,,,,2018-03-13,2018-03-15,ACTUAL,2018-03-01,ESTIMATED,2018-03-01,2018-03,2018-03-31,2023-03-01,ESTIMATED,2023-03-01,2023-03-01,ESTIMATED,2023-03-01,,INTERVENTIONAL,,,Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma,A Single Arm Pilot Study of Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Michigan Rogel Cancer Center,,1.0,,The company pulled durvalumab from heme malignancies,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,OTHER,,,,,,,2023,0.0
NCT04142242,,2019-10-24,2021-03-26,,2023-11-27,2019-10-25,2019-10-29,ACTUAL,2021-03-26,2021-04-26,ACTUAL,,,,2023-11-27,2023-12-19,ACTUAL,2019-10-04,ACTUAL,2019-10-04,2023-11,2023-11-30,2022-05-25,ACTUAL,2022-05-25,2020-04-01,ACTUAL,2020-04-01,,INTERVENTIONAL,,Analysis was performed on all enrolled participants.,Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine in Older Adults Who Received a Primary Vaccination (3 or More Years Earlier) in Study MET49,Safety and Immunogenicity of a Single Dose of MenACYW Conjugate Vaccine at Least 3 Years Following Initial Vaccination With Either Menomune® Vaccine or MenACYW Conjugate Vaccine in Older Adults,COMPLETED,,PHASE3,471.0,ACTUAL,Sanofi,,6.0,,,f,,,,f,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,INDUSTRY,,,,,,,2022,1.0
NCT04330079,,2020-03-30,,,2022-09-21,2020-03-30,2020-04-01,ACTUAL,,,,,,,2022-09-21,2022-09-23,ACTUAL,2020-05-21,ACTUAL,2020-05-21,2022-09,2022-09-30,2021-04-08,ACTUAL,2021-04-08,2021-04-08,ACTUAL,2021-04-08,,INTERVENTIONAL,,,Effects of dapaglifloziN Therapy on Myocardial Perfusion Reserve in Prediabetic Patients With Stable coronarY Artery Disease,Effects of dapaglifloziN Therapy on Myocardial Perfusion Reserve in Prediabetic Patients With Stable coronarY Artery Disease (ENTRY Trial),TERMINATED,,PHASE4,2.0,ACTUAL,Asan Medical Center,,2.0,,Slow enrollment. (Difficulty in selecting subjects),f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,OTHER,,,,,,,2021,0.0
NCT04467346,,2020-03-27,,,2022-02-21,2020-07-08,2020-07-13,ACTUAL,,,,,,,2022-02-21,2022-02-23,ACTUAL,2020-09-25,ACTUAL,2020-09-25,2022-02,2022-02-28,2021-12-17,ACTUAL,2021-12-17,2021-12-17,ACTUAL,2021-12-17,,INTERVENTIONAL,,,Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules,Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules,COMPLETED,,PHASE1,36.0,ACTUAL,Orphelia Pharma,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,INDUSTRY,,,,,,,2021,1.0
NCT04047771,,2019-08-05,,,2023-04-10,2019-08-06,2019-08-07,ACTUAL,,,,,,,2023-04-10,2023-04-12,ACTUAL,2019-09-10,ACTUAL,2019-09-10,2023-04,2023-04-30,2022-05-05,ACTUAL,2022-05-05,2022-05-05,ACTUAL,2022-05-05,,INTERVENTIONAL,,,A Phase I Study Evaluating SCB-313 for the Treatment of Subjects With Peritoneal Carcinomatosis,"A Phase I Study Evaluating the Safety, Tolerability and Pharmacokinetics of SCB-313, Recombinant Human Tumor Necrosis Factor-Related Apoptosis-Inducing Ligand-Trimer Fusion Protein, for the Treatment of Subjects With Peritoneal Carcinomatosis",TERMINATED,,PHASE1,10.0,ACTUAL,"Sichuan Clover Biopharmaceuticals, Inc.",,1.0,,terminated,f,,,,,f,f,,,,,,,,,,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,INDUSTRY,,,,,,,2022,0.0
NCT03559192,,2018-06-06,2023-05-02,2021-05-03,2023-06-23,2018-06-06,2018-06-18,ACTUAL,2023-06-23,2023-06-26,ACTUAL,,2023-06-26,ACTUAL,2023-06-23,2023-06-26,ACTUAL,2018-07-16,ACTUAL,2018-07-16,2023-06,2023-06-30,2020-05-06,ACTUAL,2020-05-06,2020-05-06,ACTUAL,2020-05-06,,INTERVENTIONAL,,,A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression,"A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of JNJ-67953964 in Subjects With Major Depressive Disorder",COMPLETED,,PHASE2,181.0,ACTUAL,"Janssen Research & Development, LLC",,3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,INDUSTRY,,,,,,,2020,1.0
NCT04622254,,2020-11-04,2024-06-13,2022-06-14,2024-07-11,2020-11-04,2020-11-09,ACTUAL,2024-07-11,2024-08-06,ACTUAL,,2024-08-06,ACTUAL,2024-07-11,2024-08-06,ACTUAL,2020-11-12,ACTUAL,2020-11-12,2024-06,2024-06-30,2022-07-08,ACTUAL,2022-07-08,2021-06-16,ACTUAL,2021-06-16,,INTERVENTIONAL,ULTRA II,The full analysis set (FAS) included all randomized subjects.,"Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Crows Feet) in Subjects With Moderate to Severe Upper Facial Lines","A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)",COMPLETED,,PHASE3,368.0,ACTUAL,"Merz North America, Inc.",,6.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,INDUSTRY,,,,,,,2022,1.0
NCT05536037,,2022-09-07,,,2024-04-17,2022-09-07,2022-09-10,ACTUAL,,,,,,,2024-04-17,2024-04-19,ACTUAL,2022-05-04,ACTUAL,2022-05-04,2024-04,2024-04-30,2024-03-16,ACTUAL,2024-03-16,2024-03-16,ACTUAL,2024-03-16,,INTERVENTIONAL,,,Metformin for the Prevention of Oral Cancer in Patients With Oral Premalignant Lesions,Metformin Chemoprevention of Oral Premalignant Lesions,TERMINATED,,PHASE1,4.0,ACTUAL,Thomas Jefferson University,,1.0,,Slow accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,OTHER,,,,,,,2024,0.0
NCT03277352,,2017-08-14,2021-07-01,,2021-07-01,2017-09-08,2017-09-11,ACTUAL,2021-07-01,2021-07-22,ACTUAL,,,,2021-07-01,2021-07-22,ACTUAL,2017-11-21,ACTUAL,2017-11-21,2021-06,2021-06-30,2020-07-01,ACTUAL,2020-07-01,2020-07-01,ACTUAL,2020-07-01,,INTERVENTIONAL,,"The Full Analysis Set (FAS) includes all subjects enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.",INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies,A Phase 1/2 Safety and Efficacy Study of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies,TERMINATED,,PHASE1/PHASE2,10.0,ACTUAL,Incyte Corporation,,1.0,,The study was terminated due to emergent data from another study and unrelated to safety.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,INDUSTRY,,,,,,,2020,0.0
NCT03276780,,2017-09-06,2021-09-01,,2024-05-06,2017-09-07,2017-09-08,ACTUAL,2021-12-17,2021-12-20,ACTUAL,,,,2024-05-06,2024-05-08,ACTUAL,2018-05-03,ACTUAL,2018-05-03,2024-05,2024-05-31,2020-10-31,ACTUAL,2020-10-31,2020-05-31,ACTUAL,2020-05-31,,INTERVENTIONAL,NRT,,Nicotine Replacement Therapy (NRT) Sampling and Selection to Increase Medication Adherence,NRT Sampling and Selection to Increase Medication Adherence,COMPLETED,,PHASE4,80.0,ACTUAL,University of Alabama at Birmingham,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,OTHER,,,,,,,2020,1.0
NCT04808882,,2021-03-08,,,2022-09-05,2021-03-19,2021-03-22,ACTUAL,,,,,,,2022-09-05,2022-09-08,ACTUAL,2021-04-14,ACTUAL,2021-04-14,2020-12,2020-12-31,2022-03-13,ACTUAL,2022-03-13,2022-01-10,ACTUAL,2022-01-10,,INTERVENTIONAL,ANTICOVID,,ANTIcoagulation in Severe COVID-19 Patients,"ANTIcoagulation in Severe COVID-19 Patients: a Multicenter, Parallel-group, Open-label, Randomized Controlled Trial",COMPLETED,,PHASE2,353.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,3.0,,,f,,,,t,f,f,,,,,,,,,NO,"DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION",2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,OTHER,,,,,,,2022,1.0
NCT04695652,,2020-12-31,,,2022-01-27,2021-01-04,2021-01-05,ACTUAL,,,,,,,2022-01-27,2022-01-31,ACTUAL,2020-12-30,ACTUAL,2020-12-30,2020-12,2020-12-31,2021-10-29,ACTUAL,2021-10-29,2021-05-15,ACTUAL,2021-05-15,,INTERVENTIONAL,COVID-19,,A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adult,"A Phase II, Prospective, Double-blinded, Multi-Center, Multi-Regional Study to Evaluate the Safety, Tolerability, and Immunogenicity of the SARS-CoV-2 Vaccine Candidate MVC-COV1901",COMPLETED,,PHASE2,3854.0,ACTUAL,Medigen Vaccine Biologics Corp.,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,INDUSTRY,,,,,,,2021,1.0
NCT04827589,,2021-03-30,,,2021-07-22,2021-03-30,2021-04-01,ACTUAL,,,,,,,2021-07-22,2021-07-28,ACTUAL,2021-07,ESTIMATED,2021-07-31,2021-07,2021-07-31,2022-09,ESTIMATED,2022-09-30,2022-04,ESTIMATED,2022-04-30,,INTERVENTIONAL,,,"Study to Evaluate the Efficacy, Safety, and Tolerability of Tirabrutinib in Participants With Antihistamine-Resistant Chronic Spontaneous Urticaria","A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Tirabrutinib in Subjects With Antihistamine-Resistant Chronic Spontaneous Urticaria",WITHDRAWN,,PHASE2,0.0,ACTUAL,Gilead Sciences,,3.0,,Development program terminated,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,INDUSTRY,,,,,,,2022,0.0
NCT05518279,,2019-01-22,,,2022-08-24,2022-08-24,2022-08-26,ACTUAL,,,,,,,2022-08-24,2022-08-26,ACTUAL,2019-09,ESTIMATED,2019-09-30,2022-08,2022-08-31,2021-09,ESTIMATED,2021-09-30,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,,,Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures,"Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures: A Prospective, Randomized, Double-blinded, Placebo Controlled Trial",WITHDRAWN,,PHASE3,0.0,ACTUAL,Henry Ford Health System,,2.0,,Could not work out internal logistics,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,OTHER,,,,,,,2021,0.0
NCT03304379,,2017-10-02,2022-12-09,2020-12-11,2023-01-30,2017-10-05,2017-10-09,ACTUAL,2023-01-30,2023-02-24,ACTUAL,2023-01-30,2023-02-24,ACTUAL,2023-01-30,2023-02-24,ACTUAL,2017-10-26,ACTUAL,2017-10-26,2023-01,2023-01-31,2020-11-09,ACTUAL,2020-11-09,2019-12-13,ACTUAL,2019-12-13,,INTERVENTIONAL,FACT OA2,,Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip,"Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo And NSAID Controlled Study To Evaluate The Efficacy And Safety Of Fasinumab In Patients With Pain Due To Osteoarthritis Of The Knee Or Hip",COMPLETED,,PHASE3,1650.0,ACTUAL,Regeneron Pharmaceuticals,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 12:01:22.407548,2024-10-15 12:01:22.407548,INDUSTRY,,,,,,,2020,1.0
NCT03469492,,2018-01-11,2022-11-18,,2024-02-01,2018-03-16,2018-03-19,ACTUAL,2023-01-18,2023-02-02,ACTUAL,,,,2024-02-01,2024-02-05,ACTUAL,2018-01-18,ACTUAL,2018-01-18,2024-02,2024-02-29,2020-03-20,ACTUAL,2020-03-20,2020-03-20,ACTUAL,2020-03-20,,INTERVENTIONAL,,,Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose,Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose: an Intervention Study,COMPLETED,,EARLY_PHASE1,8.0,ACTUAL,Yale University,,2.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER,,,,,,,2020,1.0
NCT03646344,,2018-08-20,,,2021-06-22,2018-08-23,2018-08-24,ACTUAL,,,,,,,2021-06-22,2021-06-23,ACTUAL,2019-03-12,ACTUAL,2019-03-12,2021-06,2021-06-30,2021-02-23,ACTUAL,2021-02-23,2020-03-17,ACTUAL,2020-03-17,,INTERVENTIONAL,HOT2,,Heme Arginate in Transplantation Study,Heme Arginate in Transplantation Study - a Multi-centre Blinded Parallel-group Randomised Trial of Heme Arginate Versus Placebo to Reduce Delayed Graft Function in Kidney Transplant Recipients,TERMINATED,,PHASE3,47.0,ACTUAL,University of Edinburgh,,2.0,,COVID,f,,,,t,f,f,,,f,,,,,,YES,"Following publication of the primary paper, a de-identified individual participant data set will be submitted to a data archive for sharing purposes. Access to this data set will be under a controlled access model in line with ECTU policies at that time.",2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,OTHER,,,,,,,2021,0.0
NCT04086472,,2019-09-10,2021-03-18,,2022-08-29,2019-09-10,2019-09-11,ACTUAL,2021-03-18,2021-04-13,ACTUAL,,,,2022-08-29,2022-09-14,ACTUAL,2019-10-28,ACTUAL,2019-10-28,2022-08,2022-08-31,2020-08-14,ACTUAL,2020-08-14,2020-03-22,ACTUAL,2020-03-22,,INTERVENTIONAL,,,Phase 2a Respiratory Syncytial Virus (RSV) Human Challenge Study of Clesrovimab (MK-1654) in Healthy Participants (MK-1654-005),"A Phase 2a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Participants Inoculated With Experimental Respiratory Syncytial Virus",COMPLETED,,PHASE2,80.0,ACTUAL,Merck Sharp & Dohme LLC,,5.0,,,f,,,,f,t,f,,,t,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,INDUSTRY,,,,,,,2020,1.0
NCT04353206,,2020-04-16,,,2021-11-01,2020-04-16,2020-04-20,ACTUAL,,,,,,,2021-11-01,2021-11-08,ACTUAL,2020-06-27,ACTUAL,2020-06-27,2021-11,2021-11-30,2020-11-01,ACTUAL,2020-11-01,2020-11-01,ACTUAL,2020-11-01,,INTERVENTIONAL,,,Convalescent Plasma in ICU Patients With COVID-19-induced Respiratory Failure,A Feasibility Study Assessing the Safety of Multiple Doses of Anti-SARS-CoV-2 Plasma in Mechanically Ventilated Intubated Patients With Respiratory Failure Due to COVID-19,TERMINATED,,EARLY_PHASE1,6.0,ACTUAL,Cedars-Sinai Medical Center,,1.0,,The initiation of the expanded access program for convalescent plasma.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER,,,,,,,2020,0.0
NCT02152358,,2014-03-26,,,2023-04-05,2014-05-28,2014-06-02,ESTIMATED,,,,,,,2023-04-05,2023-04-06,ACTUAL,2014-02-05,ACTUAL,2014-02-05,2023-04,2023-04-30,2023-04-05,ACTUAL,2023-04-05,2018-04-21,ACTUAL,2018-04-21,,INTERVENTIONAL,PTH,,PTH - Preemptive Treatment for Herpesviridae,"Efficacy of a Preemptive Treatment by Ganciclovir or by Aciclovir in ICU Patients Requiring Prolonged Mechanical Ventilation and Presenting a Viral Replication (CMV and/or HSV) - Prospective, Randomized, Double-blinded Multicenter Trial",COMPLETED,,PHASE4,317.0,ACTUAL,Assistance Publique Hopitaux De Marseille,,4.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,OTHER,,,,,,,2023,0.0
NCT04252664,,2020-01-31,,,2020-04-13,2020-01-31,2020-02-05,ACTUAL,,,,,,,2020-04-13,2020-04-15,ACTUAL,2020-02-12,ACTUAL,2020-02-12,2020-04,2020-04-30,2020-04-27,ESTIMATED,2020-04-27,2020-04-10,ESTIMATED,2020-04-10,,INTERVENTIONAL,,,A Trial of Remdesivir in Adults With Mild and Moderate COVID-19,"A Phase 3 Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir in Hospitalized Adult Patients With Mild and Moderate COVID-19.",SUSPENDED,,PHASE3,308.0,ESTIMATED,Capital Medical University,,2.0,,"The epidemic of COVID-19 has been controlled well at present, no eligible patients can be recruitted.",f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,OTHER,,,,,,,2020,0.0
NCT04666441,,2020-12-10,2022-03-03,,2022-03-24,2020-12-10,2020-12-14,ACTUAL,2022-03-24,2022-04-08,ACTUAL,,,,2022-03-24,2022-04-08,ACTUAL,2020-12-15,ACTUAL,2020-12-15,2022-03,2022-03-31,2021-09-21,ACTUAL,2021-09-21,2021-03-04,ACTUAL,2021-03-04,,INTERVENTIONAL,,Randomized participants who received any study drug; based on the treatment received (as treated),COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection,A Phase 2 Study to Assess the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Outpatients With SARS-CoV-2 Infection,COMPLETED,,PHASE2,1149.0,ACTUAL,Regeneron Pharmaceuticals,,8.0,,,f,,,,f,t,f,,,,,,"When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.",Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf,https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,INDUSTRY,,,,,,,2021,1.0
NCT01676441,,2012-08-23,,,2021-03-21,2012-08-28,2012-08-31,ESTIMATED,,,,,,,2021-03-21,2021-03-23,ACTUAL,2008-08,,2008-08-31,2021-03,2021-03-31,2021-03-04,ACTUAL,2021-03-04,2021-03-04,ACTUAL,2021-03-04,,INTERVENTIONAL,,,Safety and Efficacy of Autologous Mesenchymal Stem Cells in Chronic Spinal Cord Injury,A Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Chronic Spinal Cord Injury.,TERMINATED,,PHASE2/PHASE3,20.0,ACTUAL,"Pharmicell Co., Ltd.",,1.0,,sponsor decision (confidential),f,,,,f,,,,,,,,,,,,,2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,INDUSTRY,,,,,,,2021,0.0
NCT02616185,,2015-11-24,2022-01-18,,2023-01-18,2015-11-24,2015-11-26,ESTIMATED,2023-01-18,2023-11-02,ACTUAL,,,,2023-01-18,2023-11-02,ACTUAL,2015-12-30,ACTUAL,2015-12-30,2023-01,2023-01-31,2021-02-23,ACTUAL,2021-02-23,2021-02-23,ACTUAL,2021-02-23,,INTERVENTIONAL,,All enrolled participants who received at least one dose of one of the components of the regimen.,A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR),"A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ESCALATING DOSES OF A VACCINE-BASED IMMUNOTHERAPY REGIMEN (VBIR) FOR PROSTATE CANCER (PF-06753512)",TERMINATED,,PHASE1,91.0,ACTUAL,Pfizer,The study was terminated on 20 August 2020 by the sponsor. The decision to terminate this study was based on the results of a strategic evaluation of VBIR-1 within the current Pfizer oncology portfolio. This decision was not based on any safety or regulatory concerns with the treatment of participants with VBIR-1.,1.0,,"Due to strategic evaluation of PF-06753512 (VBIR-1) within context of Pfizer's oncology portfolio, decision not based on any safety or regulatory concerns.",f,,,,f,,,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,INDUSTRY,,,,,,,2021,0.0
NCT04418661,,2020-05-29,,,2024-04-29,2020-06-02,2020-06-05,ACTUAL,,,,,,,2024-04-29,2024-05-01,ACTUAL,2020-06-09,ACTUAL,2020-06-09,2024-04,2024-04-30,2024-04-04,ACTUAL,2024-04-04,2024-04-04,ACTUAL,2024-04-04,,INTERVENTIONAL,,,Safety and Efficacy Study of SAR442720 in Combination With Other Agents in Advanced Malignancies,"A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of SAR442720 in Combination With Other Agents in Participants With Advanced Malignancies",TERMINATED,,PHASE1/PHASE2,65.0,ACTUAL,Sanofi,,6.0,,Sponsor's decision not related to any safety concern,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,INDUSTRY,,,,,,,2024,0.0
NCT03174782,,2017-05-31,2023-05-04,,2023-06-07,2017-05-31,2017-06-05,ACTUAL,2023-05-04,2023-05-31,ACTUAL,,,,2023-06-07,2023-06-12,ACTUAL,2018-01-01,ACTUAL,2018-01-01,2023-06,2023-06-30,2021-04-27,ACTUAL,2021-04-27,2021-04-27,ACTUAL,2021-04-27,,INTERVENTIONAL,,,Peripheral Nerve Blocks for Major Lower Extremity Amputations,Peripheral Nerve Blocks for Major Lower Extremity Amputations,TERMINATED,,PHASE4,42.0,ACTUAL,"University of California, San Francisco",,2.0,,The study was terminated due to not enough power and research staff assistance.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER,,,,,,,2021,0.0
NCT04154826,,2019-10-28,,,2024-04-09,2019-11-04,2019-11-07,ACTUAL,,,,,,,2024-04-09,2024-04-11,ACTUAL,2020-11-30,ACTUAL,2020-11-30,2024-04,2024-04-30,2024-03-30,ACTUAL,2024-03-30,2023-12-31,ACTUAL,2023-12-31,,INTERVENTIONAL,IMPULSE-7,,Recombinant Interleukin-7 (CYT107) to Treat Patients With Refractory Nontuberculous Mycobacterial Lung Disease,"Recombinant Interleukin-7 (CYT107) to Treat Patients With Refractory Nontuberculous Mycobacterial Lung Disease. Two Doses Phase II, Single Center, Open-label Trial",TERMINATED,,PHASE2,8.0,ACTUAL,Revimmune,,2.0,,non convincing results,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,INDUSTRY,,,,,,,2024,0.0
NCT04563299,,2020-09-10,,,2023-02-20,2020-09-18,2020-09-24,ACTUAL,,,,,,,2023-02-20,2023-02-22,ACTUAL,2020-12-09,ACTUAL,2020-12-09,2023-02,2023-02-28,2023-02-14,ACTUAL,2023-02-14,2023-02-14,ACTUAL,2023-02-14,,INTERVENTIONAL,DETeR,,Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections,Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections,TERMINATED,,PHASE4,10.0,ACTUAL,Retina Vitreous Associates of Florida,,2.0,,Subject Enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER,,,,,,,2023,0.0
NCT04983901,,2021-07-21,2023-12-20,,2024-08-23,2021-07-21,2021-07-30,ACTUAL,2024-02-14,2024-03-12,ACTUAL,,,,2024-08-23,2024-08-27,ACTUAL,2021-09-14,ACTUAL,2021-09-14,2024-07,2024-07-31,2023-10-06,ACTUAL,2023-10-06,2023-10-06,ACTUAL,2023-10-06,,INTERVENTIONAL,,Patients in Modified Intent-To-Treat (MITT) analysis set.,"PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN","An Investigator Initiated, Phase II Single-Center, Randomized, Open-Label, Prospective, Study To Determine The Impact Of Serial Procalcitonin On Improving Antimicrobial Stewardship And On The Efficacy, Safety, And Tolerability Of Imipenem-Cilastatin-Relebactam Plus/Minus Vancomycin Or Linezolid Versus Standard Of Care Antipseudomonal Beta-Lactams Plus/Minus Vancomycin Or Linezolid As Empiric Therapy In Febrile Neutropenic Adults With Cancer",COMPLETED,,PHASE2,100.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,,,,,,t,t,f,,,f,,,,,,,,2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,OTHER,,,,,,,2023,1.0
NCT03399318,,2017-10-17,2023-12-01,2023-06-07,2024-02-09,2018-01-06,2018-01-16,ACTUAL,2024-02-09,2024-03-05,ACTUAL,,2023-07-20,ACTUAL,2024-02-09,2024-03-05,ACTUAL,2019-01-07,ACTUAL,2019-01-07,2024-02,2024-02-29,2022-12-02,ACTUAL,2022-12-02,2022-12-02,ACTUAL,2022-12-02,,INTERVENTIONAL,,"Eligible children were 24-132 months of age with evidence of P. falciparum infection, based upon a thick peripheral blood smear or rapid diagnostic test, and symptoms of CNS malaria including complicated seizures (multiple seizures, focal seizures or prolonged seizures lasting more than 15 minutes) or impaired consciousness",Aggressive Antipyretics for Fever Reduction in CNS Malaria,Aggressive Antipyretics in CNS Malaria: A Randomized-Controlled Trial Assessing Antipyretic Efficacy and Parasite Clearance Effects,COMPLETED,,PHASE2,256.0,ACTUAL,University of Rochester,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,OTHER,,,,,,,2022,1.0
NCT02539303,,2015-08-27,,,2022-08-02,2015-09-02,2015-09-03,ESTIMATED,,,,,,,2022-08-02,2022-08-04,ACTUAL,2015-08,,2015-08-31,2022-08,2022-08-31,2023-08,ESTIMATED,2023-08-31,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,,,Delivery of Yamani-15/5 Chemical Solution for PAD,In-vivo Demineralization of Calcific Peripheral Arterial Disease (PAD) Using Local Delivery of Yamani-15/5 Chemical Solution,WITHDRAWN,,PHASE1,0.0,ACTUAL,Mayo Clinic,,1.0,,Unable to enroll subjects,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,OTHER,,,,,,,2023,0.0
NCT05006417,,2021-08-10,2024-06-20,,2024-07-16,2021-08-10,2021-08-16,ACTUAL,2024-07-16,2024-07-18,ACTUAL,,,,2024-07-16,2024-07-18,ACTUAL,2022-11-23,ACTUAL,2022-11-23,2024-07,2024-07-31,2022-11-23,ACTUAL,2022-11-23,2022-11-23,ACTUAL,2022-11-23,,INTERVENTIONAL,,,Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome,OnabotulinumtoxinA (Botox) Effect on Pain and Function in Recurrent Chronic Exertional Compartment Syndrome: a Pilot Study,TERMINATED,,PHASE4,1.0,ACTUAL,"University of Wisconsin, Madison",,1.0,,"issues with supplier of strength testing equipment, presumed to go out of business",f,,,,,t,f,,,,,,,,,NO,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER,,,,,,,2022,0.0
NCT04991688,,2021-06-25,,,2023-10-24,2021-08-04,2021-08-05,ACTUAL,,,,,,,2023-10-24,2023-10-27,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2023-10,2023-10-31,2023-03-03,ACTUAL,2023-03-03,2023-01-07,ACTUAL,2023-01-07,,INTERVENTIONAL,BOTOX-TME,,A Prospective Pilot Study to Assess the Efficacy of BOTOX-A in Patients With Low Anterior Resection Syndrome (LARS>20) and Refractory Medical Treatment After Rectal Resection,A Prospective Pilot Study to Assess the Efficacy of Botox-A in Patients With Low Anterior Resection Syndrome (LARS>20) and Refractory Medical Treatment After Rectal Resection,TERMINATED,,PHASE2,11.0,ACTUAL,"University Hospital, Bordeaux",,1.0,,Organizational difficulties,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER,,,,,,,2023,0.0
NCT03135652,,2017-04-26,,,2023-12-31,2017-04-28,2017-05-01,ACTUAL,,,,,,,2023-12-31,2024-01-03,ACTUAL,2017-08-01,ACTUAL,2017-08-01,2023-12,2023-12-31,2023-06-01,ESTIMATED,2023-06-01,2021-06-01,ESTIMATED,2021-06-01,,INTERVENTIONAL,,,Consolidative Radiotherapy for Colorectal Cancer Liver Metastases Receiving Surgery or Radiofrequency Ablation,Consolidative Radiotherapy for Colorectal Cancer Liver Metastases Receiving Surgery or Radiofrequency Ablation,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Wuhan Union Hospital, China",,2.0,,Inadequate patient enrollment,f,,,,,f,f,,,,,,,,,,,2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,OTHER,,,,,,,2023,0.0
NCT01562626,,2012-03-22,,,2021-05-10,2012-03-22,2012-03-26,ESTIMATED,,,,,,,2021-05-10,2021-05-12,ACTUAL,2012-09,,2012-09-30,2021-05,2021-05-31,2021-05,ESTIMATED,2021-05-31,2021-05,ESTIMATED,2021-05-31,,INTERVENTIONAL,,,Phase I/II Study of APS001F With Flucytosine and Maltose in Solid Tumors,"A Phase I/II Safety, Pharmacokinetic, and Pharmacodynamic Study of APS001F With Flucytosine and Maltose for the Treatment of Advanced and/or Metastatic Solid Tumors",SUSPENDED,,PHASE1/PHASE2,75.0,ESTIMATED,"Anaeropharma Science, Inc.",,1.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,INDUSTRY,,,,,,,2021,0.0
NCT03073603,,2017-01-18,2022-07-05,,2023-08-14,2017-03-02,2017-03-08,ACTUAL,2022-09-06,2022-10-06,ACTUAL,,,,2023-08-14,2023-08-16,ACTUAL,2017-04-20,ACTUAL,2017-04-20,2023-08,2023-08-31,2021-08-31,ACTUAL,2021-08-31,2021-08-31,ACTUAL,2021-08-31,,INTERVENTIONAL,DISCOMS,,Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS),Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS),COMPLETED,,PHASE4,259.0,ACTUAL,"University of Colorado, Denver","Mostly white women; all participants in US; Relatively short follow-up (maximum 2 years); Most participants using older, injectable therapies for MS; Small numbers don't allow for significant subgroup analysis, eg not enough on high efficacy medications; Being a pragmatic study (real-world, insurance paid for MRI scans), and COVID pandemic resulted in more missing data than desirable; No brain volume data, a meaningful measure; No NfL or other serum or spinal fluid biomarker data.",2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,OTHER,,,,,,,2021,1.0
NCT04938388,,2021-06-15,,,2023-05-23,2021-06-23,2021-06-24,ACTUAL,,,,,,,2023-05-23,2023-05-25,ACTUAL,2022-01-29,ACTUAL,2022-01-29,2023-05,2023-05-31,2023-02-16,ACTUAL,2023-02-16,2023-02-16,ACTUAL,2023-02-16,,INTERVENTIONAL,,,Comparison of Oral Semaglutide w/ Placebo- Treatment for Latino Adults w/T2 Diabetes Receiving Enhanced Lifestyle Care,Comparison of Oral Semaglutide With Matched Oral Semaglutide Placebo as an Early Treatment for Latino Adults With Type 2 Diabetes Receiving Enhanced Lifestyle Care,TERMINATED,,PHASE4,12.0,ACTUAL,Sansum Diabetes Research Institute,,2.0,,Principal Investigator no longer at study site.,f,,,,,t,f,,,f,,,,,,,,2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,OTHER,,,,,,,2023,0.0
NCT03458728,,2018-02-19,2023-09-26,,2023-11-29,2018-03-07,2018-03-08,ACTUAL,2023-11-29,2023-12-04,ACTUAL,,,,2023-11-29,2023-12-04,ACTUAL,2018-04-30,ACTUAL,2018-04-30,2023-11,2023-11-30,2023-02-01,ACTUAL,2023-02-01,2023-02-01,ACTUAL,2023-02-01,,INTERVENTIONAL,,,"Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients","A Non-randomized, Open-label, Multi-center, Phase I/II Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Copanlisib in Pediatric Patients With Relapsed/Refractory Solid Tumors or Lymphoma",TERMINATED,,PHASE1/PHASE2,31.0,ACTUAL,Bayer,,5.0,,no anticipated benefit over available standard therapies,f,,,,t,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,INDUSTRY,,,,,,,2023,0.0
NCT01436227,,2011-09-15,,,2024-03-14,2011-09-16,2011-09-19,ESTIMATED,,,,,,,2024-03-14,2024-03-15,ACTUAL,2012-01-17,ACTUAL,2012-01-17,2024-03,2024-03-31,2024-03-13,ACTUAL,2024-03-13,2024-03-13,ACTUAL,2024-03-13,,INTERVENTIONAL,,,Pazopanib Hydrochloride in Treating Patients With Von Hippel-Lindau Syndrome,A Phase II Trial of Pazopanib in Von Hippel-Lindau Syndrome,COMPLETED,,PHASE2,32.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,OTHER,,,,,,,2024,1.0
NCT05470933,,2022-07-07,,,2023-08-29,2022-07-20,2022-07-22,ACTUAL,,,,,,,2023-08-29,2023-09-01,ACTUAL,2022-08-23,ACTUAL,2022-08-23,2023-08,2023-08-31,2023-04-18,ACTUAL,2023-04-18,2023-04-18,ACTUAL,2023-04-18,,INTERVENTIONAL,,,A Study Explore WJ01075 Tablets in Patients With Advanced Solid Tumors,"A Phase Ⅰ Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of WJ01075 Tablets in Oral Dose Escalation and Expansion in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1,7.0,ACTUAL,"Suzhou Junjing BioSciences Co., Ltd.",,1.0,,"Terminate the study and close the research center based on strategic changes in product development, unrelated to drug safety.",f,,,,,f,f,,,,,,,,,NO,,2024-10-16 18:02:07.470231,2024-10-16 18:02:07.470231,INDUSTRY,,,,,,,2023,0.0
NCT03289039,,2017-09-18,2022-11-15,,2024-02-09,2017-09-18,2017-09-20,ACTUAL,2023-03-17,2023-03-21,ACTUAL,,,,2024-02-09,2024-02-13,ACTUAL,2017-10-25,ACTUAL,2017-10-25,2024-02,2024-02-29,2021-07-20,ACTUAL,2021-07-20,2021-07-20,ACTUAL,2021-07-20,,INTERVENTIONAL,,The analysis population is only including treated patients.,"Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer","A Phase 2 Study of Neratinib With or Without Fulvestrant in HER2-Positive, ER-Positive Metastatic Breast Cancer",TERMINATED,,PHASE2,21.0,ACTUAL,Dana-Farber Cancer Institute,,2.0,,Slow accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,OTHER,,,,,,,2021,0.0
NCT01721746,,2012-11-02,2017-02-01,,2022-03-23,2012-11-02,2012-11-06,ESTIMATED,2017-02-01,2017-03-22,ACTUAL,,,,2022-03-23,2022-04-19,ACTUAL,2012-12-21,ACTUAL,2012-12-21,2022-03,2022-03-31,2020-12-29,ACTUAL,2020-12-29,2016-02-16,ACTUAL,2016-02-16,,INTERVENTIONAL,,All randomized participants,A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037),A Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy,COMPLETED,,PHASE3,405.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,INDUSTRY,,,,,,,2020,1.0
NCT04687930,,2020-12-19,,,2021-07-18,2020-12-23,2020-12-29,ACTUAL,,,,,,,2021-07-18,2021-07-23,ACTUAL,2020-12-01,ACTUAL,2020-12-01,2021-07,2021-07-31,2021-02-15,ACTUAL,2021-02-15,2021-02-15,ACTUAL,2021-02-15,,INTERVENTIONAL,,,Genicular Nerve Block in Juvenile Idiopathic Arthritis,Genicular Nerve Block in Juvenile Idiopathic Arthritis,COMPLETED,,PHASE4,104.0,ACTUAL,Sohag University,,2.0,,,f,,,,t,f,f,,,f,,,,,,,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,OTHER,,,,,,,2021,1.0
NCT02535078,,2015-08-26,,2024-05-16,2024-07-22,2015-08-27,2015-08-28,ESTIMATED,,,,,2024-01-24,ACTUAL,2024-07-22,2024-07-24,ACTUAL,2015-11,ACTUAL,2015-11-30,2024-07,2024-07-31,2023-09-06,ACTUAL,2023-09-06,2023-06-19,ACTUAL,2023-06-19,,INTERVENTIONAL,,,Phase 1b/2 Study of the Combination of IMCgp100 With Durvalumab and/or Tremelimumab in Advanced Cutaneous Melanoma,"A Phase Ib/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 in Combination With Durvalumab (MEDI4736) or Tremelimumab or the Combination of Durvalumab and Tremelimumab Compared to IMCgp100 Alone in Patients With Advanced Melanoma",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Immunocore Ltd,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,INDUSTRY,,,,,,,2023,0.0
NCT04400760,,2020-05-19,2023-09-21,,2023-10-16,2020-05-19,2020-05-26,ACTUAL,2023-10-16,2023-11-07,ACTUAL,,,,2023-10-16,2023-11-07,ACTUAL,2020-05-01,ACTUAL,2020-05-01,2023-10,2023-10-31,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,EDGE,,The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts.,The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts: The EDGE Study.,COMPLETED,,PHASE2/PHASE3,40.0,ACTUAL,The University of The West Indies,,1.0,,,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 18:08:27.646546,2024-10-16 18:08:27.646546,OTHER,,,,,,,2022,1.0
NCT04894474,,2021-05-18,,,2021-11-04,2021-05-18,2021-05-20,ACTUAL,,,,,,,2021-11-04,2021-11-08,ACTUAL,2021-06-17,ESTIMATED,2021-06-17,2021-11,2021-11-30,2022-07-24,ESTIMATED,2022-07-24,2022-05-23,ESTIMATED,2022-05-23,,INTERVENTIONAL,,,A Study to Test Whether BI 767551 Can Prevent COVID-19 in People Who Have Been Exposed to SARS-CoV-2,"A Phase III Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential Study to Evaluate Efficacy, Safety and Tolerability of BI 767551 for Post-exposure Prevention of SARS-CoV-2 Infection in Household Contacts to a Confirmed SARS-CoV-2 Infected Individual",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Boehringer Ingelheim,,3.0,,project terminated,f,,,,t,t,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,INDUSTRY,,,,,,,2022,0.0
NCT04390152,,2020-05-12,,,2024-08-26,2020-05-14,2020-05-15,ACTUAL,,,,,,,2024-08-26,2024-08-27,ACTUAL,2020-01-13,ACTUAL,2020-01-13,2024-08,2024-08-31,2022-03-03,ACTUAL,2022-03-03,2022-03-03,ACTUAL,2022-03-03,,INTERVENTIONAL,,,Safety and Efficacy of Intravenous Wharton's Jelly Derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Due to COVID 19,Safety and Efficacy of Intravenous Infusion of Wharton's Jelly Derived Mesenchymal Stem Cell Plus Standard Therapy for the Treatment of Patients With Acute Respiratory Distress Syndrome Diagnosis Due to COVID 19: A Randomized Controlled Trial,TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,BioXcellerator,,2.0,,"Stopped by the IP, because the first 6 patients recruited had died and it was unknown if it represented any safety risk or if the sample was insufficient to evaluate the study hypotesis.",f,,,,t,f,f,,,,,,,,,NO,Individual data won't be shared.,2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,INDUSTRY,,,,,,,2022,0.0
NCT05132569,,2021-11-12,2024-02-15,,2024-04-04,2021-11-12,2021-11-24,ACTUAL,2024-04-04,2024-04-08,ACTUAL,,,,2024-04-04,2024-04-08,ACTUAL,2021-12-03,ACTUAL,2021-12-03,2024-02,2024-02-29,2023-02-21,ACTUAL,2023-02-21,2023-02-21,ACTUAL,2023-02-21,,INTERVENTIONAL,URSA,"Analysis was performed on all randomized participants. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, data were reported under a single arm.",Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis,"A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tolebrutinib (SAR442168) in Adults With Generalized Myasthenia Gravis (MG)",TERMINATED,,PHASE3,6.0,ACTUAL,Sanofi,"The study was prematurely terminated by the Sponsor due to strategic reasons and was not based on any safety issues. Hence, several planned efficacy analysis were not conducted for the study.",2.0,,For strategic reasons the Tolebrutinib MG study has been terminated,f,,,,t,t,f,,,f,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 18:08:27.646546,2024-10-16 18:08:27.646546,INDUSTRY,,,,,,,2023,0.0
NCT05261490,,2021-11-22,,,2024-04-03,2022-02-18,2022-03-02,ACTUAL,,,,,,,2024-04-03,2024-04-05,ACTUAL,2022-08-01,ACTUAL,2022-08-01,2024-04,2024-04-30,2024-02-15,ACTUAL,2024-02-15,2024-02-15,ACTUAL,2024-02-15,,INTERVENTIONAL,,,Study of Maplirpacept (PF-07901801) in Combination With PLD in Patients With Platinum-Resistant Ovarian Cancer,A Phase Ⅰ/Ⅱ Study of TTI-622 in Combination With Pegylated Liposomal Doxorubicin in Patients With Platinum-Resistant Ovarian Cancer,TERMINATED,,PHASE1/PHASE2,10.0,ACTUAL,Pfizer,,2.0,,A business decision was made by Pfizer to terminate and remove the Phase 2 expansion of this study for administrative reasons. The reason for study termination is not due to any safety concerns or requests from regulatory authorities.,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 18:08:27.646546,2024-10-16 18:08:27.646546,INDUSTRY,,,,,,,2024,0.0
NCT03136055,,2017-04-18,2022-10-28,,2022-12-05,2017-04-26,2017-05-02,ACTUAL,2022-12-05,2022-12-27,ACTUAL,,,,2022-12-05,2022-12-27,ACTUAL,2017-06-20,ACTUAL,2017-06-20,2022-12,2022-12-31,2021-10-31,ACTUAL,2021-10-31,2021-10-31,ACTUAL,2021-10-31,,INTERVENTIONAL,,,Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas,A Pilot Study of Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas,COMPLETED,,PHASE2,36.0,ACTUAL,"University of California, San Francisco",,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,OTHER,,,,,,,2021,0.0
NCT04509674,,2020-08-10,,,2023-11-13,2020-08-10,2020-08-12,ACTUAL,,,,,,,2023-11-13,2023-11-14,ACTUAL,2020-12-16,ACTUAL,2020-12-16,2023-11,2023-11-30,2023-11-05,ACTUAL,2023-11-05,2023-11-05,ACTUAL,2023-11-05,,INTERVENTIONAL,,,EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction),"EMPACT-MI: A Streamlined, Multicentre, Randomised, Parallel Group, Double-blind Placebo-controlled Superiority Trial to Evaluate the Effect of EMPAgliflozin on Hospitalisation for Heart Failure and Mortality in Patients With aCuTe Myocardial Infarction",COMPLETED,,PHASE3,6522.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,INDUSTRY,,,,,,,2023,0.0
NCT04430283,,2020-04-20,2023-04-17,,2023-06-12,2020-06-10,2020-06-12,ACTUAL,2023-06-12,2023-06-13,ACTUAL,,,,2023-06-12,2023-06-13,ACTUAL,2021-09-20,ACTUAL,2021-09-20,2023-06,2023-06-30,2022-03-04,ACTUAL,2022-03-04,2022-03-04,ACTUAL,2022-03-04,,INTERVENTIONAL,,,Evaluation of FDY-5301 in Major Trauma Patients in ICU,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Intravenous FDY-5301 for the Prevention and Treatment of ICU Acquired Weakness in Major Trauma Patients.",TERMINATED,,PHASE2,8.0,ACTUAL,"Faraday Pharmaceuticals, Inc.",,3.0,,"The study was terminated because of difficulty identifying patients that met the inclusion criteria, as well as logistical difficulties in opening clinical ICU study sites.",f,,,,t,t,f,,,,,,,,,,,2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,INDUSTRY,,,,,,,2022,0.0
NCT04955938,,2021-06-22,,,2024-07-29,2021-07-06,2021-07-09,ACTUAL,,,,,,,2024-07-29,2024-07-31,ACTUAL,2021-10-29,ACTUAL,2021-10-29,2024-07,2024-07-31,2023-06-07,ACTUAL,2023-06-07,2023-06-07,ACTUAL,2023-06-07,,INTERVENTIONAL,,,"A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms","A Phase Ib Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms",WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Chicago,,2.0,,unable to accrue,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,OTHER,,,,,,,2023,0.0
NCT03779841,,2018-12-17,2024-03-04,2023-02-27,2024-04-17,2018-12-17,2018-12-19,ACTUAL,2024-04-17,2024-05-14,ACTUAL,,2024-05-14,ACTUAL,2024-04-17,2024-05-14,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2024-04,2024-04-30,2023-03-06,ACTUAL,2023-03-06,2022-03-24,ACTUAL,2022-03-24,,INTERVENTIONAL,,,Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery (NOVA),"A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN-151607) Injections Into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery",COMPLETED,,PHASE2,323.0,ACTUAL,AbbVie,,3.0,,,f,,,,t,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,INDUSTRY,,,,,,,2023,1.0
NCT05780216,,2023-02-23,,,2023-09-19,2023-03-21,2023-03-22,ACTUAL,,,,,,,2023-09-19,2023-09-21,ACTUAL,2023-02-20,ACTUAL,2023-02-20,2023-09,2023-09-30,2023-09-15,ACTUAL,2023-09-15,2023-08-05,ACTUAL,2023-08-05,,INTERVENTIONAL,,,Mindfulness and Psychedelics,Mindfulness and Psychedelics: A Combined Neurophenomenological and Pharmacological Approach to the Characterization of Mindfulness States in Experienced Meditators,COMPLETED,,EARLY_PHASE1,40.0,ACTUAL,"Psychiatric University Hospital, Zurich",,2.0,,,f,,,,f,f,f,,,,,,,,,NO,"Only anonymized, quantitative neurophysiological and behavioral data can be shared upon publication according to the FAIR data principles. Qualitative interview data are sensitive and cannot be shared due to confidentiality reasons.",2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER,,,,,,,2023,1.0
NCT01983462,,2013-10-30,2021-09-20,,2023-03-26,2013-11-06,2013-11-14,ESTIMATED,2023-03-26,2023-04-14,ACTUAL,,,,2023-03-26,2023-04-14,ACTUAL,2013-10,ACTUAL,2013-10-31,2023-03,2023-03-31,2020-06,ACTUAL,2020-06-30,2020-06,ACTUAL,2020-06-30,,INTERVENTIONAL,VANISH,,Vascular Dysfunction in Human Obesity Hypertension,Vascular Dysfunction in Human Obesity Hypertension: Integrative Role of Sympathetic and Renin-Angiotensin Systems,TERMINATED,,PHASE2,33.0,ACTUAL,University of Iowa,,3.0,,Funding expired,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER,,,,,,,2020,0.0
NCT04442737,,2020-06-03,2024-07-31,,2024-07-31,2020-06-18,2020-06-23,ACTUAL,2024-07-31,2024-08-27,ACTUAL,,,,2024-07-31,2024-08-27,ACTUAL,2020-07-01,ACTUAL,2020-07-01,2024-07,2024-07-31,2023-08-30,ACTUAL,2023-08-30,2023-08-07,ACTUAL,2023-08-07,,INTERVENTIONAL,DEFINE,,A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain,"A Phase 4, Randomized, Active-Controlled, Open-label Study to Evaluate the Safety and Tolerability of Switching to Once-Daily Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-dose Combination (FDC) Regimen in Virologically-suppressed Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Experiencing Rapid Weight Gain With an INI + TAF/FTC ARV Regimen",COMPLETED,,PHASE4,103.0,ACTUAL,"Janssen Scientific Affairs, LLC",,2.0,,,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,INDUSTRY,,,,,,,2023,0.0
NCT01338987,,2011-04-19,2018-11-30,,2021-03-16,2011-04-19,2011-04-20,ESTIMATED,2019-04-17,2019-04-23,ACTUAL,,,,2021-03-16,2021-03-18,ACTUAL,2011-04-19,ACTUAL,2011-04-19,2021-03,2021-03-31,2020-11-19,ACTUAL,2020-11-19,2017-12-01,ACTUAL,2017-12-01,,INTERVENTIONAL,,,Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation,Multi-Institutional Prospective Pilot Study of Lupron to Enhance Lymphocyte Immune Reconstitution Following Allogeneic Bone Marrow Transplantation in Post-Pubertal Children and Adults With Molecular Imaging Evaluation,COMPLETED,,PHASE2,76.0,ACTUAL,National Institutes of Health Clinical Center (CC),,5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:08:27.646546,2024-10-16 18:08:27.646546,NIH,,,,,,,2020,1.0
NCT02940548,,2016-10-15,,,2022-04-23,2016-10-19,2016-10-21,ESTIMATED,,,,,,,2022-04-23,2022-04-29,ACTUAL,2016-12,ACTUAL,2016-12-31,2022-04,2022-04-30,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,NARRAS,,Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness,A Comparative Study for the Effects of Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness in the Young and Middle-aged Subjects With Non-dipper Hypertension,TERMINATED,,PHASE4,99.0,ACTUAL,Peking University People's Hospital,,2.0,,The patient recruitment and follow-ups were influenced with the pandemic of COVID-19,f,,,,f,,,,,,,,,,,UNDECIDED,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,OTHER,,,,,,,2020,0.0
NCT05251233,,2022-02-11,,,2024-07-02,2022-02-11,2022-02-22,ACTUAL,,,,,,,2024-07-02,2024-07-03,ACTUAL,2022-04-21,ACTUAL,2022-04-21,2024-07,2024-07-31,2024-06-27,ACTUAL,2024-06-27,2024-06-27,ACTUAL,2024-06-27,,INTERVENTIONAL,,,Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy,Evaluation of the Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy,TERMINATED,,PHASE2,56.0,ACTUAL,Washington University School of Medicine,,2.0,,Investigator and study team chose to end study early.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,OTHER,,,,,,,2024,0.0
NCT05578508,,2019-11-01,,,2022-10-10,2022-10-10,2022-10-13,ACTUAL,,,,,,,2022-10-10,2022-10-13,ACTUAL,2022-04,ESTIMATED,2022-04-30,2022-10,2022-10-31,2024-02,ESTIMATED,2024-02-29,2024-02,ESTIMATED,2024-02-29,,INTERVENTIONAL,,,Stem Cells for the Treatment of Pouchitis,A Phase I Study of Bone Marrow Derived Mesenchymal Stem Cells (MSCs) for the Treatment of Medically Refractory Pouchitis,WITHDRAWN,,PHASE1,0.0,ACTUAL,The Cleveland Clinic,,1.0,,PI decision not to move forward with study.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER,,,,,,,2024,0.0
NCT02647359,,2015-12-29,2022-05-03,2021-11-09,2022-05-03,2016-01-04,2016-01-06,ESTIMATED,2022-05-03,2022-05-27,ACTUAL,2021-11-09,2021-11-10,ACTUAL,2022-05-03,2022-05-27,ACTUAL,2016-01-31,ACTUAL,2016-01-31,2022-04,2022-04-30,2021-01-22,ACTUAL,2021-01-22,2021-01-22,ACTUAL,2021-01-22,,INTERVENTIONAL,STAR,The safety population included all randomized participants who received at least 1 dose of study drug.,Study of Ataluren in Participants With Nonsense Mutation Aniridia,"A Phase 2, Multicenter, Randomized, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Ataluren (PTC124) for the Treatment of Nonsense Mutation Aniridia",COMPLETED,,PHASE2,39.0,ACTUAL,PTC Therapeutics,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,INDUSTRY,,,,,,,2021,1.0
NCT03608358,,2018-07-11,,,2022-05-25,2018-07-24,2018-07-31,ACTUAL,,,,,,,2022-05-25,2022-05-31,ACTUAL,2019-02-27,ACTUAL,2019-02-27,2022-05,2022-05-31,2020-08-04,ACTUAL,2020-08-04,2020-08-04,ACTUAL,2020-08-04,,INTERVENTIONAL,,,Safety and Efficacy of Dapagliflozin in Asian T2DM Subjects With Inadequate Glycemic Control on Metformin/Saxagliptin,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Asian Subjects With T2DM and Inadequate Glycemic Control on Metformin and Saxagliptin (DS Navigation)",TERMINATED,,PHASE3,41.0,ACTUAL,AstraZeneca,,3.0,,Sponsor decided to stop commercialization of QTERNMet/Qtrilmet and to stop all related ongoing activities/studies for business reasons.,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,INDUSTRY,,,,,,,2020,0.0
NCT04205136,,2019-12-11,,,2022-04-11,2019-12-17,2019-12-19,ACTUAL,,,,,,,2022-04-11,2022-04-19,ACTUAL,2022-03,ESTIMATED,2022-03-31,2022-04,2022-04-30,2023-04,ESTIMATED,2023-04-30,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,,,Spironolactone to Improve Apnea and Cardiovascular Markers in Obstructive Sleep Apnea Patients,Spironolactone to Improve Apnea and Cardiovascular Markers in Obstructive Sleep Apnea Patients With Cardiovascular Disease Who Are Non-Adherent With Positive Airway Pressure: A Randomized Placebo-Controlled Pilot Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Michigan,,2.0,,Was on hold due to Covid then we were not able to initiate the funding again after such a long hold and loss of team members.,f,,,,,t,f,,,,,,,,,NO,"The study team does not have plans to actively share data, however, they are open to collaboration following contact with the investigator.",2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER,,,,,,,2023,0.0
NCT04286594,,2020-02-25,2024-08-01,,2024-08-23,2020-02-25,2020-02-27,ACTUAL,2024-08-23,2024-08-27,ACTUAL,,,,2024-08-23,2024-08-27,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2024-08,2024-08-31,2023-08-24,ACTUAL,2023-08-24,2023-08-24,ACTUAL,2023-08-24,,INTERVENTIONAL,,,A Clinical Trial of a Hemp-Derived Cannabidiol Product for Anxiety,A Clinical Trial of a Hemp-Derived Cannabidiol Product for Anxiety,TERMINATED,,PHASE2,15.0,ACTUAL,Mclean Hospital,,1.0,,Terminated by sponsor,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,OTHER,,,,,,,2023,0.0
NCT04369469,,2020-04-28,2022-02-15,,2022-05-04,2020-04-28,2020-04-30,ACTUAL,2022-05-04,2022-05-24,ACTUAL,,,,2022-05-04,2022-05-24,ACTUAL,2020-05-10,ACTUAL,2020-05-10,2022-05,2022-05-31,2021-04-08,ACTUAL,2021-04-08,2021-02-08,ACTUAL,2021-02-08,,INTERVENTIONAL,,The ITT Population consisted of all randomized participants. Participants were analyzed as randomized.,Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia,"A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared With Best Supportive Care in Patients With COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome",TERMINATED,,PHASE3,202.0,ACTUAL,"Alexion Pharmaceuticals, Inc.","Enrollment of participants was paused on 13-Jan-2021. At that time, 202 participants had been randomized. An interim analysis for efficacy and futility was conducted on data from the first 122 participants who completed the Primary Evaluation Period. The analysis showed that the study met the prespecified stopping criteria for futility. After review of all participant data, Alexion terminated the study on 01-Sep-2021.",2.0,,Met futility bar at interim analysis,f,,,,t,t,f,,,,,,,,,YES,"Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.",2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,INDUSTRY,,,,,,,2021,0.0
NCT05676697,,2022-12-07,,,2024-02-05,2022-12-22,2023-01-09,ACTUAL,,,,,,,2024-02-05,2024-02-07,ACTUAL,2023-01-13,ACTUAL,2023-01-13,2024-02,2024-02-29,2024-02-06,ACTUAL,2024-02-06,2024-01-31,ACTUAL,2024-01-31,,INTERVENTIONAL,,,PI3K Delta Inhibitor in Relapsed / Refractory Autoimmune Hemolytic Anemia Patients After Receiving Two or More Lines of Therapy,Safety and Efficacy Study of PI3K Delta Inhibitor in Relapsed / Refractory Autoimmune Hemolytic Anemia Patients After Receiving Two or More Lines of Therapy,TERMINATED,,PHASE1,4.0,ACTUAL,"Institute of Hematology & Blood Diseases Hospital, China",,1.0,,Did not meet the anticipated outcome.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,OTHER,,,,,,,2024,0.0
NCT03709550,,2018-10-12,,,2022-10-03,2018-10-12,2018-10-17,ACTUAL,,,,,,,2022-10-03,2022-10-05,ACTUAL,2021-04-15,ESTIMATED,2021-04-15,2022-10,2022-10-31,2024-04-15,ESTIMATED,2024-04-15,2023-04-15,ESTIMATED,2023-04-15,,INTERVENTIONAL,,,Enzalutamide and Decitabine in Treating Patients With Metastatic Castration Resistant Prostate Cancer,"Phase Ib/II Study of Enzalutamide With Decitabine, a DNA Hypomethylating Agent, in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC)",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Roswell Park Cancer Institute,,1.0,,lack of funding,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,OTHER,,,,,,,2024,0.0
NCT04432831,,2020-06-12,,,2024-08-23,2020-06-12,2020-06-16,ACTUAL,,,,,,,2024-08-23,2024-08-27,ACTUAL,2020-08-05,ACTUAL,2020-08-05,2024-08,2024-08-31,2023-10-11,ACTUAL,2023-10-11,2023-10-11,ACTUAL,2023-10-11,,INTERVENTIONAL,Rhone-X,,A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema,"A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Diabetic Macular Edema",COMPLETED,,PHASE3,1479.0,ACTUAL,Hoffmann-La Roche,,1.0,,,f,,,,f,t,f,,,,,,,,,YES,"For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing",2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,INDUSTRY,,,,,,,2023,1.0
NCT05112419,,2021-10-11,,,2022-01-26,2021-11-05,2021-11-08,ACTUAL,,,,,,,2022-01-26,2022-01-27,ACTUAL,2021-11-10,ACTUAL,2021-11-10,2022-01,2022-01-31,2021-12-15,ACTUAL,2021-12-15,2021-12-15,ACTUAL,2021-12-15,,INTERVENTIONAL,,,A Study to Assess Zibotentan Pharmacokinetics in Participants With Moderate Hepatic and Moderate Renal Impairment,"A Single Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Zibotentan in Healthy Participants Compared to Participants With Moderate Hepatic and Moderate Renal Impairment",COMPLETED,,PHASE1,12.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 18:08:27.646546,2024-10-16 18:08:27.646546,INDUSTRY,,,,,,,2021,1.0
NCT01850004,,2013-05-08,2018-09-20,,2022-10-05,2013-05-08,2013-05-09,ESTIMATED,2018-10-31,2018-11-02,ACTUAL,,,,2022-10-05,2022-11-03,ACTUAL,2014-01-22,ACTUAL,2014-01-22,2022-10,2022-10-31,2021-10-08,ACTUAL,2021-10-08,2017-09-20,ACTUAL,2017-09-20,,INTERVENTIONAL,DASFREE,,Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response,Open-Label Single Arm Phase 2 Study Evaluating Dasatinib Therapy Discontinuation In Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) With Stable Complete Molecular Response (CMR) DASFREE,COMPLETED,,PHASE2,84.0,ACTUAL,Bristol-Myers Squibb,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,INDUSTRY,,,,,,,2021,1.0
NCT03251924,,2017-08-15,2022-12-16,,2023-01-31,2017-08-15,2017-08-16,ACTUAL,2023-01-31,2023-02-28,ACTUAL,,,,2023-01-31,2023-02-28,ACTUAL,2017-09-01,ACTUAL,2017-09-01,2023-01,2023-01-31,2021-12-20,ACTUAL,2021-12-20,2021-12-20,ACTUAL,2021-12-20,,INTERVENTIONAL,,,A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors,"A Phase 1/2 Dose Escalation and Combination Cohort Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Efficacy of BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,80.0,ACTUAL,Bristol-Myers Squibb,Study CA021002 was terminated because the Sponsor discontinued further development of BMS-986226. The decision for the study closure was not related to any safety concerns associated with BMS-986226.,3.0,,Study CA021-002 was terminated because the Sponsor discontinued further development of BMS-986226 due to a change in business objectives. The decision for the study closure was not related to any safety concerns associated with BMS-986226.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,INDUSTRY,,,,,,,2021,0.0
NCT04969861,,2021-07-09,2022-10-24,,2022-12-16,2021-07-09,2021-07-21,ACTUAL,2022-11-21,2022-12-15,ACTUAL,,,,2022-12-16,2023-01-12,ACTUAL,2022-03-09,ACTUAL,2022-03-09,2022-11,2022-11-30,2022-04-22,ACTUAL,2022-04-22,2022-04-22,ACTUAL,2022-04-22,,INTERVENTIONAL,,"Following the Sponsor's decision to end the trial, treatment was discontinued after one patient received 2 cycles of BEMPEG + Pembrolizumab",BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36),"A Phase 2/3, Randomized, Open-label Study to Compare Bempegaldesleukin Combined With Pembrolizumab Versus Pembrolizumab Alone in First-Line Treatment of Patients With Metastatic or Recurrent Head and Neck Squamous-Cell Carcinoma With PD-L1 Expressing Tumors (PROPEL-36)",TERMINATED,,PHASE2/PHASE3,1.0,ACTUAL,Nektar Therapeutics,,2.0,,"Nektar Therapeutics made the decision to discontinue the bempegaldesleukin program based on three negative studies. SFJ Pharmaceuticals, Inc. and Nektar Therapeutics, in consultation with the study IDMC, have decided to discontinue PROPEL-36.",f,,,,t,t,f,,,,,,,,,,,2024-10-16 18:08:27.646546,2024-10-16 18:08:27.646546,INDUSTRY,,,,,,,2022,0.0
NCT04243824,,2020-01-24,,,2021-01-13,2020-01-24,2020-01-28,ACTUAL,,,,,,,2021-01-13,2021-01-15,ACTUAL,2021-05,ESTIMATED,2021-05-31,2021-01,2021-01-31,2022-05,ESTIMATED,2022-05-31,2022-05,ESTIMATED,2022-05-31,,INTERVENTIONAL,,,Ga-68 MAA Distribution in PAE Patients,The Evaluation of Ga-68 MAA Distribution in Prostatic Artery Embolization Patients,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,"University of North Carolina, Chapel Hill",,1.0,,Lack of funding,f,,,,f,t,f,,,,,,9 to 36 months following publication,"The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.",,YES,"Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.",2024-10-15 12:06:56.398553,2024-10-15 12:06:56.398553,OTHER,,,,,,,2022,0.0
NCT03185013,,2017-06-09,2023-06-30,2021-07-01,2023-07-24,2017-06-09,2017-06-14,ACTUAL,2023-06-30,2023-07-25,ACTUAL,2021-07-01,2021-07-06,ACTUAL,2023-07-24,2023-07-27,ACTUAL,2017-06-28,ACTUAL,2017-06-28,2023-07,2023-07-31,2021-04-06,ACTUAL,2021-04-06,2020-07-08,ACTUAL,2020-07-08,,INTERVENTIONAL,REVEAL 1,ITT population included all participants who were randomized.,REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL),"A Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™-5PSP for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Cervix",COMPLETED,,PHASE3,201.0,ACTUAL,Inovio Pharmaceuticals,,2.0,,,f,,,,t,t,t,t,,,,,,,,,,2024-10-16 18:08:27.646546,2024-10-16 18:08:27.646546,INDUSTRY,,,,,,,2021,1.0
NCT04354441,,2020-04-14,,,2020-06-23,2020-04-17,2020-04-21,ACTUAL,,,,,,,2020-06-23,2020-06-25,ACTUAL,2020-05,ESTIMATED,2020-05-31,2020-06,2020-06-30,2020-05,ESTIMATED,2020-05-31,2020-05,ESTIMATED,2020-05-31,,INTERVENTIONAL,HyPreC,,Effect of Hydroxychloroquine in COVID-19 Positive Pregnant Women,Randomized Trial Evaluating Effect of Outpatient Hydroxychloroquine on Reducing Hospital Admissions in Pregnant Women With SARS-CoV-2 Infection: HyPreC Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,Sir Mortimer B. Davis - Jewish General Hospital,,2.0,,Not started,f,,,,t,f,f,,,,,,,,,,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,OTHER,,,,,,,2020,0.0
NCT03042312,,2017-01-18,2021-01-14,,2021-03-01,2017-02-02,2017-02-03,ESTIMATED,2021-03-01,2021-03-24,ACTUAL,,,,2021-03-01,2021-03-24,ACTUAL,2017-07-12,ACTUAL,2017-07-12,2021-03,2021-03-31,2020-01-15,ACTUAL,2020-01-15,2020-01-15,ACTUAL,2020-01-15,,INTERVENTIONAL,RESIST-PC,,Lutetium-177 (Lu177) Prostate-Specific Antigen (PSMA)-Directed EndoRadiotherapy,PSMA-directed endoRadiothErapy of Castration-reSISTant Prostate Cancer (RESIST-PC). A Phase II Clinical Trial,TERMINATED,,PHASE2,71.0,ACTUAL,Endocyte,The study began on 05-Jul-17 as an Investigator Initiated Trial and sponsorship was transferred to Endocyte on 01-Jun-18. Recruitment was stopped before the target sample size was achieved based on strategic considerations.,2.0,,Recruitment was stopped before the target sample size was achieved.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,INDUSTRY,,,,,,,2020,0.0
NCT02541045,,2015-08-31,,,2024-03-13,2015-09-01,2015-09-04,ESTIMATED,,,,,,,2024-03-13,2024-03-15,ACTUAL,2015-08,ACTUAL,2015-08-31,2024-03,2024-03-31,2024-03,ACTUAL,2024-03-31,2024-03,ACTUAL,2024-03-31,,INTERVENTIONAL,,,Clinical Trial to Evaluate the Efficacy of Metadoxine as a Therapy for Patients With Non-alcoholic Steatohepatitis,Clinical Trial to Evaluate the Efficacy of Metadoxine as a Therapy for Patients With Non-alcoholic Steatohepatitis,WITHDRAWN,,PHASE3,0.0,ACTUAL,Hospital General de Mexico,,2.0,,lack of resources to finance the project,f,,,,t,,,,,,,,,,,,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER_GOV,,,,,,,2024,0.0
NCT02626455,,2015-11-03,,,2023-11-28,2015-12-08,2015-12-10,ESTIMATED,,,,,,,2023-11-28,2023-12-01,ACTUAL,2016-01-06,ACTUAL,2016-01-06,2023-11,2023-11-30,2023-11-10,ACTUAL,2023-11-10,2023-09-15,ACTUAL,2023-09-15,,INTERVENTIONAL,CHRONOS-4,,Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL),"A Phase III, Randomized, Double-blind, Controlled Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination With Standard Immunochemotherapy Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)",TERMINATED,,PHASE3,547.0,ACTUAL,Bayer,,2.0,,"The study did not meet the primary endpoint. The addition of copanlisib to standard immunochemo therapy did not improve progression-free survival compared to the control arm. Base on the study results, company decided to terminate the study.",f,,,,t,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,INDUSTRY,,,,,,,2023,0.0
NCT04414631,,2020-05-19,,,2021-11-01,2020-06-02,2020-06-04,ACTUAL,,,,,,,2021-11-01,2021-11-09,ACTUAL,2020-08-06,ACTUAL,2020-08-06,2021-11,2021-11-30,2021-09-15,ACTUAL,2021-09-15,2021-09-15,ACTUAL,2021-09-15,,INTERVENTIONAL,,,Conestat Alfa in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19,"Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group, Open-label, Multi-center Pilot Trial (PROTECT-COVID-19).",TERMINATED,,PHASE2,80.0,ACTUAL,"University Hospital, Basel, Switzerland",,2.0,,Aim to enroll 120 patients deemed not sufficient to show a difference in the primary outcome measure. Standard of care treatment recently changed in Switzerland adding further heterogeneity to trial population when including future participants.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER,,,,,,,2021,0.0
NCT04632940,,2020-11-12,2024-06-12,,2024-08-01,2020-11-12,2020-11-17,ACTUAL,2024-08-01,2024-08-26,ACTUAL,,,,2024-08-01,2024-08-26,ACTUAL,2021-03-03,ACTUAL,2021-03-03,2024-07,2024-07-31,2023-12-14,ACTUAL,2023-12-14,2023-06-12,ACTUAL,2023-06-12,,INTERVENTIONAL,LELANTOS-2,The intent-to-treat (ITT) set included all randomized participants.,Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD,"A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination With Systemic Corticosteroids in Ambulatory Subjects With Duchenne Muscular Dystrophy (DMD)",TERMINATED,,PHASE3,73.0,ACTUAL,FibroGen,,2.0,,Study did not meet its primary endpoint.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,INDUSTRY,,,,,,,2023,0.0
NCT04661033,,2020-12-01,2024-06-06,,2024-08-23,2020-12-08,2020-12-09,ACTUAL,2024-08-23,2024-08-27,ACTUAL,,,,2024-08-23,2024-08-27,ACTUAL,2021-09-09,ACTUAL,2021-09-09,2024-08,2024-08-31,2023-06-26,ACTUAL,2023-06-26,2023-06-26,ACTUAL,2023-06-26,,INTERVENTIONAL,,"Safety population included all participants exposed to the investigational medicinal product (IMP) (regardless of the amount of treatment administered). The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.","Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)","A Multicenter, Open-label, Non-randomized, Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia",TERMINATED,,PHASE2,8.0,ACTUAL,Sanofi,"The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.",4.0,,Study discontinuation based on strategic sponsor decision; not driven by any safety concerns.,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,INDUSTRY,,,,,,,2023,0.0
NCT01610206,,2012-05-30,2020-03-06,,2021-02-08,2012-05-31,2012-06-01,ESTIMATED,2021-02-08,2021-02-25,ACTUAL,,,,2021-02-08,2021-02-25,ACTUAL,2012-09,ACTUAL,2012-09-30,2021-02,2021-02-28,2020-12-31,ACTUAL,2020-12-31,2018-06-01,ACTUAL,2018-06-01,,INTERVENTIONAL,,All eligible and randomized participants who received study treatment.,A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer,"A Randomized Open Label Phase II Study of Weekly Gemcitabine Plus Pazopanib Versus Weekly Gemcitabine Alone in the Treatment of Patients With Persistent or Relapsed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma",COMPLETED,,PHASE2,148.0,ACTUAL,University of Virginia,"Our study is limited by lack of placebo control, independent pathology and radiologic review, and correlative science. We did not collect data regarding quality of life, and the study was performed in an unselected patient population.",2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,OTHER,,,,,,,2020,1.0
NCT04920916,,2021-06-08,2023-09-13,,2023-10-09,2021-06-08,2021-06-10,ACTUAL,2023-10-09,2023-11-03,ACTUAL,,,,2023-10-09,2023-11-03,ACTUAL,2021-05-25,ACTUAL,2021-05-25,2023-10,2023-10-31,2023-04-18,ACTUAL,2023-04-18,2023-04-18,ACTUAL,2023-04-18,,INTERVENTIONAL,SafeDrop,,Safety and Efficacy of Dupilumab for Treatment of Hospitalized COVID-19 Patients,Safety and Efficacy of the Treatment of Hospitalized Patients With COVID 19 Infection With an Inhibitor of IL-4 and IL-13 Signaling: A Phase IIa Trial,COMPLETED,,PHASE2,40.0,ACTUAL,University of Virginia,"This was a small study, designed as an early phase trial. Limitations included lack of achievement of the primary endpoint and the wide confidence intervals in the survival benefit of dupilumab at day 60. Additional limitations included unequal gender distribution between groups (also due to small sample size), patients were almost exclusively infected by the Delta variant of SARS CoV-2 and a higher-than-expected overall mortality rate.",2.0,,,f,,,,f,t,f,,,,,,,,,YES,,2024-10-16 18:08:27.646546,2024-10-16 18:08:27.646546,OTHER,,,,,,,2023,0.0
NCT03745586,,2018-11-06,,,2021-06-21,2018-11-16,2018-11-19,ACTUAL,,,,,,,2021-06-21,2021-06-22,ACTUAL,2018-12-01,ACTUAL,2018-12-01,2021-06,2021-06-30,2021-03-01,ACTUAL,2021-03-01,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,GUSTO,,Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab,Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab,COMPLETED,,PHASE1/PHASE2,18.0,ACTUAL,"Insel Gruppe AG, University Hospital Bern",,1.0,,,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,OTHER,,,,,,,2021,1.0
NCT04759846,,2020-12-21,,,2023-02-17,2021-02-15,2021-02-18,ACTUAL,,,,,,,2023-02-17,2023-02-21,ACTUAL,2021-01-21,ACTUAL,2021-01-21,2023-02,2023-02-28,2023-05,ESTIMATED,2023-05-31,2023-05,ESTIMATED,2023-05-31,,INTERVENTIONAL,,,Hepatic Impairment Study of Encorafenib in Combination With Binimetinib in BRAF Melanoma,"'An Open Label, Multicentre, Phase I Study to Evaluate the Impact of Moderate and Severe Hepatic Impairments on the Pharmacokinetics and Safety of Encorafenib in Combination With Binimetinib in Adult Patients With Unresectable or Metastatic BRAF V600-mutant Solid Tumors'.",WITHDRAWN,,PHASE1,0.0,ACTUAL,Pierre Fabre Medicament,,3.0,,no recruitment,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,INDUSTRY,,,,,,,2023,0.0
NCT02165345,,2014-06-13,,,2022-02-22,2014-06-16,2014-06-17,ESTIMATED,,,,,,,2022-02-22,2022-02-23,ACTUAL,2014-07-16,ACTUAL,2014-07-16,2022-02,2022-02-28,2021-11-24,ACTUAL,2021-11-24,2021-11-24,ACTUAL,2021-11-24,,INTERVENTIONAL,,,Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis,Long-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis,COMPLETED,,PHASE1,82.0,ACTUAL,Hoffmann-La Roche,,1.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,INDUSTRY,,,,,,,2021,1.0
NCT04685499,,2020-12-22,2022-12-15,,2022-12-15,2020-12-22,2020-12-28,ACTUAL,2022-12-15,2023-01-11,ACTUAL,,,,2022-12-15,2023-01-11,ACTUAL,2021-05-03,ACTUAL,2021-05-03,2022-12,2022-12-31,2022-06-03,ACTUAL,2022-06-03,2022-03-08,ACTUAL,2022-03-08,,INTERVENTIONAL,,,"Phase 2 Study of OBP-301 (Telomelysin™) in Combination With Pembrolizumab and SBRT in Patients With HNSCC With Inoperable, Recurrent or Progressive Disease","Phase 2 Study of OBP-301 (Telomelysin ™) in Combination With Pembrolizumab and Stereotactic Body Irradiation in Patients With Head and Neck Squamous Cell Carcinoma With Inoperable, Recurrent or Progressive Disease",TERMINATED,,PHASE2,1.0,ACTUAL,Weill Medical College of Cornell University,,1.0,,This study was terminated due to low participant enrollment.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,OTHER,,,,,,,2022,0.0
NCT04197479,,2019-12-11,,,2023-08-30,2019-12-11,2019-12-13,ACTUAL,,,,,,,2023-08-30,2023-09-05,ACTUAL,2019-12-16,ACTUAL,2019-12-16,2023-08,2023-08-31,2023-01-06,ACTUAL,2023-01-06,2023-01-06,ACTUAL,2023-01-06,,INTERVENTIONAL,MAESTRO-NAFLD1,,A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients,"A 52-Week, Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) (MAESTRO-NAFLD-1)",COMPLETED,,PHASE3,1343.0,ACTUAL,"Madrigal Pharmaceuticals, Inc.",,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:53:19.582327,2024-10-15 22:53:19.582327,INDUSTRY,,,,,,,2023,1.0
NCT04570384,,2020-09-17,2022-09-27,,2023-01-26,2020-09-29,2020-09-30,ACTUAL,2023-01-26,2023-02-22,ACTUAL,,,,2023-01-26,2023-02-22,ACTUAL,2020-10-15,ACTUAL,2020-10-15,2023-01,2023-01-31,2021-09-30,ACTUAL,2021-09-30,2021-08-30,ACTUAL,2021-08-30,,INTERVENTIONAL,,,Intravenous L-Citrulline Influence on the Need for Invasive Mechanical Ventilation for Acute Hypoxemic Respiratory Failure in Patients With COVID-19,"Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous L-Citrulline (Turnobi) to Delay and Potentially Prevent the Need for Invasive Mechanical Ventilation for Acute Hypoxemic Respiratory Failure in Patients With COVID-19 (SARS-CoV-2) Illness",COMPLETED,,PHASE2,65.0,ACTUAL,"Asklepion Pharmaceuticals, LLC",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,INDUSTRY,,,,,,,2021,1.0
NCT05647447,,2022-11-01,,,2024-02-19,2022-12-07,2022-12-12,ACTUAL,,,,,,,2024-02-19,2024-02-21,ACTUAL,2023-01-03,ACTUAL,2023-01-03,2024-02,2024-02-29,2023-10-05,ACTUAL,2023-10-05,2023-09-22,ACTUAL,2023-09-22,,INTERVENTIONAL,POSH-MAP,,Pilot of Osanetant to Reduce Severity of Hot Flashes in Men With Adenocarcinoma of the Prostate,Pilot of Osanetant to Reduce Severity of Hot Flashes in Men With Adenocarcinoma of the Prostate (POSH-MAP),WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Kansas Medical Center,,1.0,,Development of the drug program has been discontinued,f,,,,,t,f,,,,,,,,,,,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,OTHER,,,,,,,2023,0.0
NCT02506114,,2015-07-21,2021-10-25,2021-04-19,2021-10-25,2015-07-21,2015-07-22,ESTIMATED,2021-10-25,2021-11-24,ACTUAL,2021-04-19,2021-04-21,ACTUAL,2021-10-25,2021-11-24,ACTUAL,2016-10-06,ACTUAL,2016-10-06,2021-10,2021-10-31,2020-04-22,ACTUAL,2020-04-22,2020-04-22,ACTUAL,2020-04-22,,INTERVENTIONAL,,,Neoadjuvant PROSTVAC-VF With or Without Ipilimumab for Prostate Cancer,"An Open Label, Randomized Phase 2 Trial of Prostvac and Ipilimumab as Monotherapy or in Combination for Men With Localized Prostate Cancer Undergoing Radical Prostatectomy",TERMINATED,,PHASE2,15.0,ACTUAL,"University of California, San Francisco","Study was terminated early due to low accrual, thus outcomes are not sufficiently powered for statistical significance.",3.0,,Low Accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,OTHER,,,,,,,2020,0.0
NCT04729790,,2021-01-20,,,2021-01-25,2021-01-25,2021-01-29,ACTUAL,,,,,,,2021-01-25,2021-01-29,ACTUAL,2020-01-10,ESTIMATED,2020-01-10,2021-01,2021-01-31,2022-04-30,ESTIMATED,2022-04-30,2022-01-30,ESTIMATED,2022-01-30,,INTERVENTIONAL,FMT,,Randomized Clinical Trial of Standard FMT Treatments,Phase II Randomized Clinical Trial of Standard FMT Treatments: Non-powered Pilot Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (RCDI) Using Either Single or Three Combined Products From Healthy Donors,WITHDRAWN,,PHASE2,0.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,No Funding,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,OTHER,,,,,,,2022,0.0
NCT02654132,,2015-12-31,2019-01-17,,2022-10-05,2016-01-12,2016-01-13,ESTIMATED,2019-05-31,2019-06-03,ACTUAL,,,,2022-10-05,2022-11-01,ACTUAL,2016-03-18,ACTUAL,2016-03-18,2022-10,2022-10-31,2021-10-21,ACTUAL,2021-10-21,2018-01-17,ACTUAL,2018-01-17,,INTERVENTIONAL,,All randomized participants,An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3),"An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)",COMPLETED,,PHASE2,117.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2021,1.0
NCT04338906,,2020-04-03,,,2020-12-17,2020-04-06,2020-04-08,ACTUAL,,,,,,,2020-12-17,2020-12-21,ACTUAL,2020-05,ESTIMATED,2020-05-31,2020-12,2020-12-31,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,CLOCC,,Combination Therapy With Camostat Mesilate + Hydroxychloroquine for COVID-19,Evaluation of the Efficacy and Safety of Camostat Mesilate + Hydroxychloroquine Combination Therapy in Hospitalized Patients With Moderate COVID-19 Infection,WITHDRAWN,,PHASE4,0.0,ACTUAL,"Heinrich-Heine University, Duesseldorf",,2.0,,lack of public funding; planned control arm with Hydroxychloroquine treatment showed out as not being standard of care anymore as time evolved.,f,,,,t,f,f,,,,,,3 Months after publication,Open,,YES,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,OTHER,,,,,,,2021,0.0
NCT03043430,,2017-01-30,,,2023-04-23,2017-02-02,2017-02-06,ESTIMATED,,,,,,,2023-04-23,2023-04-25,ACTUAL,2016-05,ACTUAL,2016-05-31,2023-04,2023-04-30,2023-04,ACTUAL,2023-04-30,2023-04,ACTUAL,2023-04-30,,INTERVENTIONAL,,,Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients,Anxiolysis for Emergency Department Procedures in Pediatric Patients Using Intranasal Ketamine Compared With Intranasal Midazolam: A Randomized Controlled Trial,TERMINATED,,PHASE4,10.0,ACTUAL,Brooke Army Medical Center,,2.0,,Research manpower shortage,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,FED,,,,,,,2023,0.0
NCT01982175,,2013-11-05,,,2022-06-15,2013-11-05,2013-11-13,ESTIMATED,,,,,,,2022-06-15,2022-06-21,ACTUAL,2011-07,,2011-07-31,2022-06,2022-06-30,2022-06,ESTIMATED,2022-06-30,2021-02,ACTUAL,2021-02-28,,INTERVENTIONAL,CLL004,,Phase II Clinical Trial of Alemtuzumab to Treat B-cell Chronic Lymphocytic Leukemia,"A Multi-center, Open, Prospective, Phase II Study of Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection in Patients With Relapse and Refractory B-cell Chronic Lymphocytic Leukemia",SUSPENDED,,PHASE2,120.0,ESTIMATED,Shanghai Zhangjiang Biotechnology Limited Company,,1.0,,recruiting difficulties,f,,,,f,,,,,,,,,,,,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2022,0.0
NCT04028388,,2019-07-17,2024-01-11,,2024-03-20,2019-07-19,2019-07-22,ACTUAL,2024-03-20,2024-04-17,ACTUAL,,,,2024-03-20,2024-04-17,ACTUAL,2019-07-17,ACTUAL,2019-07-17,2024-01,2024-01-31,2021-11-29,ACTUAL,2021-11-29,2021-11-29,ACTUAL,2021-11-29,,INTERVENTIONAL,,Baseline characteristics have been provided for the Full Analysis Set (FAS). All patients who received at least 1 dose of intravenous docetaxel (Cohort 1) or 1 full cycle of ModraDoc006/r (Cohort 2) and had at least 1 post-baseline tumor assessment were included in the FAS.,ModraDoc006/r vs Docetaxel IV in Metastatic Prostate Cancer,"A Multicentre Phase 2b Trial to Evaluate the Efficacy and Tolerability of ModraDoc006/r in Subjects With Metastatic Castration Resistant Prostate Cancer (mCRPC), Suitable for Treatment With a Taxane",COMPLETED,,PHASE2,135.0,ACTUAL,Modra Pharmaceuticals,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,INDUSTRY,,,,,,,2021,1.0
NCT05496894,,2022-07-28,,,2022-12-13,2022-08-09,2022-08-11,ACTUAL,,,,,,,2022-12-13,2022-12-15,ACTUAL,2022-08,ESTIMATED,2022-08-31,2022-12,2022-12-31,2022-11-08,ACTUAL,2022-11-08,2022-11-08,ACTUAL,2022-11-08,,INTERVENTIONAL,,,A Study of Mitoxantrone Hydrochloride Liposome Injection for Relapsing Multiple Sclerosis,A Phase Ⅱ Study to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection for Relapsing Multiple Sclerosis,WITHDRAWN,,PHASE2,0.0,ACTUAL,"CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.",,3.0,,"Due to the company's project adjustment, decided to stop this study",f,,,,,f,f,,,,,,,,,NO,,2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,INDUSTRY,,,,,,,2022,0.0
NCT00251433,,2005-11-08,,,2023-03-29,2005-11-09,2005-11-10,ESTIMATED,,,,,,,2023-03-29,2023-03-31,ACTUAL,2005-09-26,ACTUAL,2005-09-26,2023-03,2023-03-31,2022-06-22,ACTUAL,2022-06-22,2010-06-10,ACTUAL,2010-06-10,,INTERVENTIONAL,,,GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer,"An Open-label, Multicenter, Phase I/II Dose Escalation Study of Oral GW572016 in Combination With Docetaxel (Taxotere) Plus Trastuzumab (Herceptin) in Subjects Previously Untreated for ErbB2-overexpressing Metastatic Breast Cancer",TERMINATED,,PHASE1,53.0,ACTUAL,Novartis,,1.0,,EGF100161 (NCT00251433) was terminated in Phase I (Phase II expansion portion of the study was never initiated) by sponsor decision.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,INDUSTRY,,,,,,,2022,0.0
NCT01845805,,2013-04-16,2022-03-31,,2022-09-26,2013-04-30,2013-05-03,ESTIMATED,2022-06-29,2022-07-22,ACTUAL,,,,2022-09-26,2022-10-04,ACTUAL,2014-01-10,ACTUAL,2014-01-10,2022-06,2022-06-30,2021-04-09,ACTUAL,2021-04-09,2021-04-09,ACTUAL,2021-04-09,,INTERVENTIONAL,,,Trial to Improve Outcomes in Patients With Resected Pancreatic Cancer (Azacitidine),A Phase II Trial to Improve Outcomes in Patients With Resected Pancreatic Adenocarcinoma at High Risk for Recurrence Using Epigenetic Therapy,COMPLETED,,PHASE2,49.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,OTHER,,,,,,,2021,0.0
NCT04825223,,2021-03-25,,,2024-08-23,2021-03-30,2021-04-01,ACTUAL,,,,,,,2024-08-23,2024-08-27,ACTUAL,2021-03-29,ACTUAL,2021-03-29,2024-08,2024-08-31,2022-07-22,ACTUAL,2022-07-22,2022-07-22,ACTUAL,2022-07-22,,INTERVENTIONAL,,,"Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants","Safety and Immunogenicity of an Investigational Multicomponent Meningococcal Group B Vaccine in Adults, Adolescents, Toddlers, and Infants",TERMINATED,,PHASE1,576.0,ACTUAL,Sanofi,,8.0,,Sponsor decision. Termination decision not related to any safety concern.,f,,,,f,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,INDUSTRY,,,,,,,2022,0.0
NCT03995004,,2019-06-20,,,2022-05-31,2019-06-20,2019-06-21,ACTUAL,,,,,,,2022-05-31,2022-06-03,ACTUAL,2022-10,ESTIMATED,2022-10-31,2021-10,2021-10-31,2024-09,ESTIMATED,2024-09-30,2024-09,ESTIMATED,2024-09-30,,INTERVENTIONAL,,,The Effect of Melatonin on Postoperative Pain Reduction After Orthognathic Surgery,The Effect of Melatonin on Postoperative Pain Reduction After Orthognathic Surgery,SUSPENDED,,PHASE1,87.0,ESTIMATED,The University of Hong Kong,,3.0,,Unable to secure study medication supply,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,OTHER,,,,,,,2024,0.0
NCT02656849,,2016-01-11,,,2016-06-29,2016-01-13,2016-01-15,ESTIMATED,,,,,,,2016-06-29,2016-07-01,ESTIMATED,2016-02,,2016-02-29,2016-06,2016-06-30,2023-05,ESTIMATED,2023-05-31,2019-10,ESTIMATED,2019-10-31,,INTERVENTIONAL,,,"BAY 1000394 for MCL-1-, MYC-, and CCNE1-Amplified Tumors","A Phase II Study of BAY 1000394 in MCL1-Amplified, MYC-Amplified, CCNE1-Amplified Tumors",WITHDRAWN,,PHASE2,0.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,Development of BAY1000394 has been terminated by Bayer.,f,,,,t,,,,,,,,,,,,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,OTHER,,,,,,,2023,0.0
NCT05095480,,2021-10-01,,,2021-10-15,2021-10-15,2021-10-27,ACTUAL,,,,,,,2021-10-15,2021-10-27,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2021-10,2021-10-31,2021-04-01,ACTUAL,2021-04-01,2021-03-01,ACTUAL,2021-03-01,,INTERVENTIONAL,,,Effect of Red Yeast Rice Beside Statin on Lipid Profile,Does Adding Red Yeast Rice to Statin Can Improve Lipid Profile or Vascular Inflammation? A Randomized Clinical Trial,COMPLETED,,PHASE4,92.0,ACTUAL,Shiraz University of Medical Sciences,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,only the result of study is available,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,OTHER,,,,,,,2021,1.0
NCT04394351,,2020-05-07,2024-02-23,2023-06-01,2024-08-23,2020-05-17,2020-05-19,ACTUAL,2024-08-23,2024-08-27,ACTUAL,,2024-08-27,ACTUAL,2024-08-23,2024-08-27,ACTUAL,2020-09-01,ACTUAL,2020-09-01,2024-08,2024-08-31,2024-05-14,ACTUAL,2024-05-14,2022-06-02,ACTUAL,2022-06-02,,INTERVENTIONAL,EoE KIDS,Analysis was performed on Part A full analysis set (FAS) which included all randomized participants in Part A.,Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE),"A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis",COMPLETED,,PHASE3,102.0,ACTUAL,Regeneron Pharmaceuticals,,5.0,,,t,,,,t,t,f,,,,,,"Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.","Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).",https://vivli.org/,YES,All Individual Patient Data that underlie publicly available results will be considered for sharing,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,INDUSTRY,,NCT04776694,AVAILABLE,,,,2024,1.0
NCT03403634,,2018-01-11,2021-11-01,,2022-02-25,2018-01-17,2018-01-18,ACTUAL,2022-02-25,2022-03-02,ACTUAL,,,,2022-02-25,2022-03-02,ACTUAL,2018-04-19,ACTUAL,2018-04-19,2022-02,2022-02-28,2021-08-29,ACTUAL,2021-08-29,2020-12-23,ACTUAL,2020-12-23,,INTERVENTIONAL,,"There were 19 patients accrued to the study; however, 4 never received any treatment and became ineligible.","Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver",Phase 2a Study Evaluating a Chemokine-Modulatory Regimen in Patients With Colorectal Cancer Metastatic to the Liver,COMPLETED,,PHASE2,19.0,ACTUAL,Roswell Park Cancer Institute,,1.0,,,,,,,t,t,f,,,t,,,,,,,,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,OTHER,,,,,,,2021,1.0
NCT04378075,,2020-05-04,,2024-03-06,2024-08-23,2020-05-04,2020-05-07,ACTUAL,,,,,2024-03-08,ACTUAL,2024-08-23,2024-08-27,ACTUAL,2020-09-28,ACTUAL,2020-09-28,2024-07,2024-07-31,2023-12-27,ACTUAL,2023-12-27,2023-03-18,ACTUAL,2023-03-18,,INTERVENTIONAL,MIT-E,,A Study to Evaluate Efficacy and Safety of Vatiquinone for Treating Mitochondrial Disease in Participants With Refractory Epilepsy,Efficacy and Safety Study of Vatiquinone for the Treatment of Mitochondrial Disease Subjects With Refractory Epilepsy,TERMINATED,,PHASE2/PHASE3,68.0,ACTUAL,PTC Therapeutics,,2.0,,Sponsor decision.,,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,INDUSTRY,,,,,,,2023,0.0
NCT02485899,,2015-04-24,2021-12-10,,2022-07-28,2015-06-29,2015-06-30,ESTIMATED,2022-07-28,2022-08-24,ACTUAL,,,,2022-07-28,2022-08-24,ACTUAL,2015-02,ACTUAL,2015-02-28,2022-07,2022-07-31,2020-12-10,ACTUAL,2020-12-10,2020-12-10,ACTUAL,2020-12-10,,INTERVENTIONAL,,"The demographic characteristics of the enrolled population are summarized for the 190-201/202 study (24 subjects). The demographic characteristics of the control group (NH comparator) which were necessary to determine the primary efficacy outcome measures, are also included (42 subjects).",An Extension Study to Evaluate the Long-Term Efficacy and Safety of BMN 190 in Patients With CLN2 Disease,"A Multicenter, Multinational, Extension Study to Evaluate the Long-Term Efficacy and Safety of BMN 190 in Patients With CLN2 Disease",COMPLETED,,PHASE1/PHASE2,23.0,ACTUAL,BioMarin Pharmaceutical,,1.0,,,f,,,,t,t,t,,,,,,,,,,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2020,1.0
NCT03751423,,2018-11-20,,,2022-09-07,2018-11-20,2018-11-23,ACTUAL,,,,,,,2022-09-07,2022-09-08,ACTUAL,2019-06-10,ACTUAL,2019-06-10,2022-09,2022-09-30,2023-12-31,ESTIMATED,2023-12-31,2023-12-31,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Intravenous Ketamine for Pain Control During First Trimester Surgical Abortion,Intravenous Ketamine for Pain Control During First Trimester Surgical Abortion,SUSPENDED,,PHASE3,123.0,ESTIMATED,Queen's University,,3.0,,Study on-hold due to COVID-19 pandemic restrictions. Will resume when possible.,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,OTHER,,,,,,,2023,0.0
NCT05134194,,2021-11-09,,,2024-04-14,2021-11-22,2021-11-24,ACTUAL,,,,,,,2024-04-14,2024-04-16,ACTUAL,2022-01-17,ACTUAL,2022-01-17,2024-04,2024-04-30,2022-12-15,ACTUAL,2022-12-15,2022-01-17,ACTUAL,2022-01-17,,INTERVENTIONAL,,,A Study of Camrelizumab in Combination With Chemotherapy Regimen Comparative Chemotherapy Regimen for Metastatic Triple-negative Breast Cancer,"A Muti-center, Open-label, Randomized, Phase III Study of Camrelizumab Plus Treatment of Physician Choice Versus Treatment of Physician Choice for Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Systemic Chemotherapy Regimens for Advanced/Metastatic Setting",TERMINATED,,PHASE3,1.0,ACTUAL,"Suzhou Suncadia Biopharmaceuticals Co., Ltd.",,2.0,,Sponsor R \& D Strategy Adjustment\],f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-16 18:08:27.646546,2024-10-16 18:08:27.646546,INDUSTRY,,,,,,,2022,0.0
NCT03603964,,2018-07-19,2022-07-20,,2024-07-31,2018-07-19,2018-07-27,ACTUAL,2023-04-05,2023-04-26,ACTUAL,,,,2024-07-31,2024-08-27,ACTUAL,2018-07-18,ACTUAL,2018-07-18,2024-07,2024-07-31,2021-10-04,ACTUAL,2021-10-04,2021-10-04,ACTUAL,2021-10-04,,INTERVENTIONAL,,Efficacy population included all participants who received any amount of study treatment.,Guadecitabine Extension Study,"An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Guadecitabine Clinical Studies",TERMINATED,,PHASE2,35.0,ACTUAL,"Astex Pharmaceuticals, Inc.",The study was terminated early not due to participant safety.,1.0,,Early termination not due to patient safety,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,INDUSTRY,,,,,,,2021,0.0
NCT03941093,,2019-05-02,,,2024-08-22,2019-05-05,2019-05-07,ACTUAL,,,,,,,2024-08-22,2024-08-26,ACTUAL,2019-05-10,ACTUAL,2019-05-10,2024-06,2024-06-30,2024-06-11,ACTUAL,2024-06-11,2024-06-11,ACTUAL,2024-06-11,,INTERVENTIONAL,LAPIS,,Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced Pancreatic Cancer,"A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in Combination With Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX as Neoadjuvant Treatment in Patients With Locally Advanced, Unresectable Pancreatic Cancer",COMPLETED,,PHASE3,284.0,ACTUAL,FibroGen,,2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,INDUSTRY,,,,,,,2024,0.0
NCT04965753,,2021-06-26,,,2024-04-23,2021-07-07,2021-07-16,ACTUAL,,,,,,,2024-04-23,2024-04-25,ACTUAL,2021-08-17,ACTUAL,2021-08-17,2024-04,2024-04-30,2023-12-04,ACTUAL,2023-12-04,2023-12-04,ACTUAL,2023-12-04,,INTERVENTIONAL,,,FHD-609 in Subjects With Advanced Synovial Sarcoma or Advanced SMARCB1-Loss Tumors,"A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Intravenously Administered FHD-609 in Subjects With Advanced Synovial Sarcoma or Advanced SMARCB1-Loss Tumors",TERMINATED,,PHASE1,55.0,ACTUAL,Foghorn Therapeutics Inc.,,1.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2023,0.0
NCT03756220,,2018-10-30,,,2020-10-27,2018-11-26,2018-11-28,ACTUAL,,,,,,,2020-10-27,2020-10-28,ACTUAL,2018-12-01,ACTUAL,2018-12-01,2020-10,2020-10-31,2020-04-14,ACTUAL,2020-04-14,2020-01-13,ACTUAL,2020-01-13,,INTERVENTIONAL,ATESS,,Ascorbic Acid and Thiamine Effect in Septic Shock,"Combination Therapy of Vitamin C and Thiamine for Septic Shock: Multi-center, Double-blinded, Randomized, Controlled Study",COMPLETED,,PHASE2,116.0,ACTUAL,Samsung Medical Center,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,OTHER,,,,,,,2020,0.0
NCT04993352,,2021-07-08,,,2023-10-20,2021-07-28,2021-08-06,ACTUAL,,,,,,,2023-10-20,2023-10-23,ACTUAL,2021-07-15,ACTUAL,2021-07-15,2023-10,2023-10-31,2023-03-13,ACTUAL,2023-03-13,2022-07-07,ACTUAL,2022-07-07,,INTERVENTIONAL,,,Evaluate the Safety and Efficacy of HLX04-O in Subjects With wAMD,"A Phase I/II, Single-arm, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of HLX04-O Administered by Intravitreal Injection in Subjects With Wet Age Related Macular Degeneration (wAMD)",COMPLETED,,PHASE1/PHASE2,20.0,ACTUAL,Shanghai Henlius Biotech,,1.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,INDUSTRY,,,,,,,2023,1.0
NCT04400799,,2020-05-15,,,2022-05-17,2020-05-22,2020-05-26,ACTUAL,,,,,,,2022-05-17,2022-05-25,ACTUAL,2020-06-15,ACTUAL,2020-06-15,2022-05,2022-05-31,2022-04-12,ACTUAL,2022-04-12,2022-02-07,ACTUAL,2022-02-07,,INTERVENTIONAL,,,Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With COVID-19,Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With Coronavirus: The Multicenter Randomized Controlled Ovid Trial,TERMINATED,,PHASE3,475.0,ACTUAL,University of Zurich,,2.0,,due to results from interim analysis,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,OTHER,,,,,,,2022,0.0
NCT03326674,,2017-10-13,,,2021-07-26,2017-10-25,2017-10-31,ACTUAL,,,,,,,2021-07-26,2021-07-30,ACTUAL,2017-12-21,ACTUAL,2017-12-21,2021-07,2021-07-31,2021-06-28,ACTUAL,2021-06-28,2020-08-24,ACTUAL,2020-08-24,,INTERVENTIONAL,CONTESSA,,"Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC","A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane",TERMINATED,,PHASE3,685.0,ACTUAL,"Odonate Therapeutics, Inc.",,2.0,,The Sponsor has discontinued the development of tesetaxel,f,,,,t,t,f,,,,,,,,,UNDECIDED,Currently under evaluation by the organization,2024-10-16 18:08:27.646546,2024-10-16 18:08:27.646546,INDUSTRY,,,,,,,2021,0.0
NCT04521335,,2020-08-18,,,2023-03-09,2020-08-18,2020-08-20,ACTUAL,,,,,,,2023-03-09,2023-03-13,ACTUAL,2021-05-21,ACTUAL,2021-05-21,2023-03,2023-03-31,2022-02-06,ACTUAL,2022-02-06,2021-12-09,ACTUAL,2021-12-09,,INTERVENTIONAL,Repurpose-1,,Study of Disulfiram and Copper Gluconate in Patients With Treatment-Refractory Multiple Myeloma,A Phase I Study of Disulfiram and Copper Gluconate in Patients With Treatment-Refractory Multiple Myeloma,TERMINATED,,PHASE1,2.0,ACTUAL,University of Utah,,1.0,,Closed at PI's Request,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,OTHER,,,,,,,2022,0.0
NCT05020249,,2021-08-20,2023-08-24,,2024-03-21,2021-08-20,2021-08-25,ACTUAL,2024-03-21,2024-03-22,ACTUAL,,,,2024-03-21,2024-03-22,ACTUAL,2021-09-27,ACTUAL,2021-09-27,2024-03,2024-03-31,2022-09-06,ACTUAL,2022-09-06,2022-09-05,ACTUAL,2022-09-05,,INTERVENTIONAL,,Baseline Characteristics refer to the Randomized Set which consisted of all randomized study participants.,A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis,"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis",COMPLETED,,PHASE3,47.0,ACTUAL,UCB Pharma,"This study protocol was not submitted to FDA, and was not conducted under a US IND or IDE.",2.0,,,f,,,,f,f,f,,,f,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",http://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-16 18:08:27.646546,2024-10-16 18:08:27.646546,INDUSTRY,,,,,,,2022,1.0
NCT05399368,,2022-05-26,,,2024-06-12,2022-05-26,2022-06-01,ACTUAL,,,,,,,2024-06-12,2024-06-14,ACTUAL,2022-06-07,ACTUAL,2022-06-07,2024-06,2024-06-30,2024-05-24,ACTUAL,2024-05-24,2024-05-24,ACTUAL,2024-05-24,,INTERVENTIONAL,,,An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis,A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 as Monotherapy in Adults With Moderate-to-Severe Atopic Dermatitis,TERMINATED,,PHASE2,229.0,ACTUAL,"RAPT Therapeutics, Inc.",,4.0,,Study on clinical hold by FDA,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2024,0.0
NCT05219578,,2022-01-06,,,2022-12-07,2022-01-28,2022-02-02,ACTUAL,,,,,,,2022-12-07,2022-12-09,ACTUAL,2022-01-12,ACTUAL,2022-01-12,2022-12,2022-12-31,2022-11-30,ACTUAL,2022-11-30,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,,,RTX-224 Monotherapy in Patients With Solid Tumors,A Phase 1/2 Study of RTX-224 for the Treatment of Patients With Advanced Solid Tumors,TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,Rubius Therapeutics,,2.0,,"The Sponsor terminated study after dosing 2 dose groups (7 pts) and closed trial on 11/30/22. RTX-224 was well-tolerated with no DLTs, no related deaths, SAEs or Gr. 3/4 AEs and cleared rapidly (w/in 10 min).",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2022,0.0
NCT02550652,,2015-09-14,2020-01-14,,2024-07-31,2015-09-14,2015-09-15,ESTIMATED,2020-02-12,2020-02-26,ACTUAL,,,,2024-07-31,2024-08-27,ACTUAL,2015-11-13,ACTUAL,2015-11-13,2024-07,2024-07-31,2023-08-02,ACTUAL,2023-08-02,2019-01-15,ACTUAL,2019-01-15,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN),"A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis",COMPLETED,,PHASE2,126.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,,,,,,,,,,,NO,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,INDUSTRY,,,,,,,2023,1.0
NCT04480164,,2020-06-11,,,2023-05-08,2020-07-16,2020-07-21,ACTUAL,,,,,,,2023-05-08,2023-05-10,ACTUAL,2020-06-24,ACTUAL,2020-06-24,2023-05,2023-05-31,2023-05-31,ESTIMATED,2023-05-31,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,NDMC-201,,Evaluation of the Safety and Efficacy of N-desmethylclobazam in Patients With Peripheral Neuropathic Pain,A Randomized Double-blind Ascending-dose Placebo-controlled Study of N-desmethylclobazam in Patients With Peripheral Neuropathic Pain,SUSPENDED,,PHASE2,76.0,ESTIMATED,"University Hospital, Geneva",,4.0,,low recruitment rate and end of study finding,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,OTHER,,,,,,,2023,0.0
NCT02678312,,2016-02-04,2022-07-01,,2023-01-12,2016-02-04,2016-02-09,ESTIMATED,2023-01-12,2023-02-10,ACTUAL,,,,2023-01-12,2023-02-10,ACTUAL,2016-11-03,ACTUAL,2016-11-03,2023-01,2023-01-31,2022-01-03,ACTUAL,2022-01-03,2022-01-03,ACTUAL,2022-01-03,,INTERVENTIONAL,,"Full Analysis Set included all randomized participants who received study drug, with the exception of \[2 patients in Part 2\] who had not received any study drug, but had been inadvertently randomized into the study (mis-randomized).","Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure","Multicenter, Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCZ696 Followed by a 52-week Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared With Enalapril in Pediatric Patients From 1 Month to < 18 Years of Age With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction",COMPLETED,,PHASE2/PHASE3,393.0,ACTUAL,Novartis,,3.0,,,f,,,,t,t,,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel based on scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,INDUSTRY,,,,,,,2022,0.0
NCT04129086,,2019-10-10,2023-03-30,,2023-03-30,2019-10-14,2019-10-16,ACTUAL,2023-03-30,2023-04-21,ACTUAL,,,,2023-03-30,2023-04-21,ACTUAL,2020-07-01,ACTUAL,2020-07-01,2023-03,2023-03-31,2022-09-30,ACTUAL,2022-09-30,2022-03-30,ACTUAL,2022-03-30,,INTERVENTIONAL,KAPT,,Ketamine for Acute Pain Management After Trauma,Ketamine for Acute Pain After Trauma: KAPT Trial,COMPLETED,,PHASE4,305.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,OTHER,,,,,,,2022,1.0
NCT02584777,,2015-10-21,,,2021-05-03,2015-10-21,2015-10-23,ESTIMATED,,,,,,,2021-05-03,2021-05-05,ACTUAL,2015-11-30,ACTUAL,2015-11-30,2021-05,2021-05-31,2020-08-31,ACTUAL,2020-08-31,2017-09-30,ACTUAL,2017-09-30,,INTERVENTIONAL,,,"A Phase II Non-Controlled, Open-Label, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Pacritinib in Myelofibrosis","A Phase II, Prospective, Non-Controlled, Open-Label, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Pacritinib in Asian Subjects With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis or Post- Essential Thrombocythemia Myelofibrosis",WITHDRAWN,,PHASE2,0.0,ACTUAL,Takeda,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 08:53:05.830542,2024-10-16 08:53:05.830542,INDUSTRY,,,,,,,2020,0.0
NCT01952847,,2013-09-24,2022-03-02,,2022-06-14,2013-09-24,2013-09-30,ESTIMATED,2022-06-14,2022-06-15,ACTUAL,,,,2022-06-14,2022-06-15,ACTUAL,2014-07-10,ACTUAL,2014-07-10,2022-06,2022-06-30,2021-03-03,ACTUAL,2021-03-03,2021-03-03,ACTUAL,2021-03-03,,INTERVENTIONAL,,Data were unavailable for 1 participant who withdrew consent after randomization but before treatment start in mTOR Inhibitor Patient Group-Placebo,Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis,"Randomized, Double Blinded Placebo-Controlled Study of Glutamine in Patients With Oral Mucositis on an mTOR Inhibitor-based Regimen or Esophagitis on a Regimen Receiving Radiation to the Esophagus",TERMINATED,,PHASE3,77.0,ACTUAL,M.D. Anderson Cancer Center,,4.0,,Per PI,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,OTHER,,,,,,,2021,0.0
NCT03024996,,2017-01-17,2023-04-18,,2023-07-14,2017-01-17,2017-01-19,ESTIMATED,2023-07-14,2023-08-03,ACTUAL,,,,2023-07-14,2023-08-03,ACTUAL,2017-01-03,ACTUAL,2017-01-03,2023-07,2023-07-31,2022-12-08,ACTUAL,2022-12-08,2022-05-03,ACTUAL,2022-05-03,,INTERVENTIONAL,IMmotion010,,A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy,"A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy",TERMINATED,,PHASE3,778.0,ACTUAL,Hoffmann-La Roche,,2.0,,"The sponsor decided to terminate this study before the protocol-defined end-of-study, as permitted per protocol.",f,,,,t,,,,,,,,,,,,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2022,0.0
NCT03722498,,2018-10-25,,,2023-07-09,2018-10-25,2018-10-29,ACTUAL,,,,,,,2023-07-09,2023-07-11,ACTUAL,2018-06-01,ACTUAL,2018-06-01,2023-07,2023-07-31,2021-03-22,ESTIMATED,2021-03-22,2021-03-22,ESTIMATED,2021-03-22,,INTERVENTIONAL,,,Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE,"Randomized Phase Ⅱ Study of Second-line Treatment Comparing Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, 5-fluorouracil and Leucovorin With Sorafenib in Hepatocellular Carcinoma Refractory to Transarterial Chemoembolization",WITHDRAWN,,PHASE2,0.0,ACTUAL,Sun Yat-sen University,,2.0,,No patients join,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,OTHER,,,,,,,2021,0.0
NCT04333732,,2020-03-31,2022-09-22,,2024-02-27,2020-04-02,2020-04-03,ACTUAL,2024-02-27,2024-03-26,ACTUAL,,,,2024-02-27,2024-03-26,ACTUAL,2020-09-04,ACTUAL,2020-09-04,2024-01,2024-01-31,2021-12-03,ACTUAL,2021-12-03,2021-08-10,ACTUAL,2021-08-10,,INTERVENTIONAL,CROWN CORONA,,CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION,"An International, Multi-site, Bayesian Platform Adaptive, Randomized, Placebo-controlled Trial Assessing the Effectiveness of Candidate Agents in Mitigating COVID-19 Disease in Adults",COMPLETED,,PHASE3,3411.0,ACTUAL,Washington University School of Medicine,,2.0,,,f,,,,t,t,f,,,,,,From 3 months after the last patient last visit onward.,Investigators whose proposed use of the data has been approved by a review committee identified for this purpose.,,YES,"Individual participant data that underlie the results reported in the main publication may be shared, after de-identification.",2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,OTHER,,,,,,,2021,1.0
NCT04042077,,2019-07-29,2021-08-06,,2022-01-25,2019-07-31,2019-08-01,ACTUAL,2021-10-01,2021-10-29,ACTUAL,,,,2022-01-25,2022-02-02,ACTUAL,2019-09-25,ACTUAL,2019-09-25,2020-11,2020-11-30,2020-10-28,ACTUAL,2020-10-28,2020-10-07,ACTUAL,2020-10-07,,INTERVENTIONAL,DRESS,ITT analysis population used as reference,Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections,"A Randomized, Observer-blinded, Active-controlled, Phase Illb Study to Compare IV / Oral Delafloxacin Fixed-dose Monotherapy With Best Available Treatments in a Microbiologically Enriched Population With Surgical Site Infections",TERMINATED,,PHASE3,268.0,ACTUAL,Menarini Group,,2.0,,COVID-19 seriously affected the study execution as required by the protocol,f,,,,f,t,f,,,t,,,,,,,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2020,0.0
NCT05092750,,2021-09-21,,,2023-09-25,2021-10-12,2021-10-26,ACTUAL,,,,,,,2023-09-25,2023-09-28,ACTUAL,2021-09-15,ACTUAL,2021-09-15,2023-09,2023-09-30,2023-08-29,ACTUAL,2023-08-29,2023-08-29,ACTUAL,2023-08-29,,INTERVENTIONAL,,,Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer,Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,0 accrual,f,,,,f,f,f,,,,,,,,,,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,OTHER,,,,,,,2023,0.0
NCT03616821,,2018-08-01,,,2023-11-08,2018-08-01,2018-08-06,ACTUAL,,,,,,,2023-11-08,2023-11-09,ACTUAL,2018-08-07,ACTUAL,2018-08-07,2023-10,2023-10-31,2023-10-23,ACTUAL,2023-10-23,2023-10-23,ACTUAL,2023-10-23,,INTERVENTIONAL,Expedition,,Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis,"A 54-Week, Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in)",TERMINATED,,PHASE2,242.0,ACTUAL,AstraZeneca,,3.0,,Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.,f,,,,t,t,f,,,t,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,INDUSTRY,,,,,,,2023,0.0
NCT04487444,,2020-07-22,,,2023-02-12,2020-07-24,2020-07-27,ACTUAL,,,,,,,2023-02-12,2023-02-14,ACTUAL,2020-09-10,ACTUAL,2020-09-10,2022-11,2022-11-30,2023-02-03,ACTUAL,2023-02-03,2023-02-03,ACTUAL,2023-02-03,,INTERVENTIONAL,Ta1,,Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection,A Pilot Trial of Thymalfasin (Ta1) to Treat COVID-19 Infection in Patients With Lymphocytopenia,TERMINATED,,PHASE2,56.0,ACTUAL,Rhode Island Hospital,,2.0,,The study was terminated due to slow enrollment and the transfer of the PI to another institution.,,,,,t,t,f,,,,,,,,,NO,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,OTHER,,,,,,,2023,0.0
NCT04109313,,2019-09-27,2023-09-05,,2024-06-17,2019-09-27,2019-09-30,ACTUAL,2023-09-05,2023-09-29,ACTUAL,,,,2024-06-17,2024-06-20,ACTUAL,2019-10-24,ACTUAL,2019-10-24,2024-06,2024-06-30,2022-09-09,ACTUAL,2022-09-09,2022-09-09,ACTUAL,2022-09-09,,INTERVENTIONAL,,,An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU,"An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Eligible Subjects With CSU Who Have Participated in CLOU064A2201",COMPLETED,,PHASE2,229.0,ACTUAL,Novartis,,1.0,,,f,,,,f,t,f,,,,,,,,,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-16 18:08:27.646546,2024-10-16 18:08:27.646546,INDUSTRY,,,,,,,2022,1.0
NCT02520245,,2015-08-05,,,2016-11-04,2015-08-10,2015-08-11,ESTIMATED,,,,,,,2016-11-04,2016-11-06,ESTIMATED,2015-08,,2015-08-31,2016-05,2016-05-31,2023-11,ESTIMATED,2023-11-30,2023-11,ESTIMATED,2023-11-30,,INTERVENTIONAL,,,Companion Study for Patients Who Completed Participation in a REGN2810 (Anti-PD-1) Clinical Study,,WITHDRAWN,,PHASE1,0.0,ACTUAL,Regeneron Pharmaceuticals,,1.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,INDUSTRY,,,,,,,2023,0.0
NCT05155982,,2021-11-30,,,2022-08-05,2021-11-30,2021-12-14,ACTUAL,,,,,,,2022-08-05,2022-08-10,ACTUAL,2022-06,ESTIMATED,2022-06-30,2022-08,2022-08-31,2023-10,ESTIMATED,2023-10-31,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,"A Clinical Trial of COVAC-1, a COVID-19 Vaccine, in Generally Healthy Adults","A Randomized, Observer-Blind, Dose-Escalation, Placebo-Controlled Phase 1 Clinical Trial of COVAC-1 in Generally Healthy Adults",WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Saskatchewan,,8.0,,Decided not to move forward with the study design.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,OTHER,,,,,,,2023,0.0
NCT03610048,,2018-07-26,2021-05-01,,2021-06-29,2018-07-26,2018-08-01,ACTUAL,2021-06-29,2021-07-16,ACTUAL,,,,2021-06-29,2021-07-16,ACTUAL,2018-08-09,ACTUAL,2018-08-09,2021-06,2021-06-30,2020-05-01,ACTUAL,2020-05-01,2020-05-01,ACTUAL,2020-05-01,,INTERVENTIONAL,,,A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD),A Phase 3b Extension Study of Adjunctive ALKS 5461 in the Treatment of Refractory Major Depressive Disorder,TERMINATED,,PHASE3,175.0,ACTUAL,"Alkermes, Inc.",,1.0,,Sponsor Decision,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,INDUSTRY,,,,,,,2020,0.0
NCT06074094,,2023-09-13,,,2023-10-05,2023-10-05,2023-10-10,ACTUAL,,,,,,,2023-10-05,2023-10-10,ACTUAL,2021-09-12,ACTUAL,2021-09-12,2023-06,2023-06-30,2023-03-01,ACTUAL,2023-03-01,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,Probiotic Supplementation IN NAFLD Patients,Effect of Probiotic Supplementation on Non-alcoholic Fatty Liver Disease in Patients Attending Family Medicine Clinic in Ain Shams University Hospitals,COMPLETED,,PHASE4,50.0,ACTUAL,Ain Shams University,,2.0,,,f,,,,f,f,f,,,f,,,,,,UNDECIDED,when appropriate.,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,OTHER,,,,,,,2023,0.0
NCT05195749,,2022-01-11,,,2023-02-22,2022-01-18,2022-01-19,ACTUAL,,,,,,,2023-02-22,2023-02-24,ACTUAL,2022-01-13,ACTUAL,2022-01-13,2023-02,2023-02-28,2023-02-14,ACTUAL,2023-02-14,2023-02-14,ACTUAL,2023-02-14,,INTERVENTIONAL,,,"A Prospective, Phase II Study to Evaluate Safety of 101-PGC-005 ('005) for Moderate to Severe COVID-19 Disease Along With Standard of Care","A Prospective, Phase II Study to Evaluate Safety of 101-PGC-005 ('005) for Moderate to Severe COVID-19 Disease Along With Standard of Care",TERMINATED,,PHASE2,3.0,ACTUAL,101 Therapeutics,,2.0,,Low Enrollment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 18:08:27.646546,2024-10-16 18:08:27.646546,INDUSTRY,,,,,,,2023,0.0
NCT04313088,,2020-03-16,,,2023-05-02,2020-03-16,2020-03-18,ACTUAL,,,,,,,2023-05-02,2023-05-06,ACTUAL,2022-07-01,ESTIMATED,2022-07-01,2023-05,2023-05-31,2024-12,ESTIMATED,2024-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Investigation of Eluxadoline for Diabetic Diarrhea,"Double Blind, Placebo Controlled, Cross Over Study to Investigate the Effectiveness and Safety of Eluxadoline in the Treatment of Diabetic Diarrhea",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Temple University,,2.0,,This study did not enroll any subjects,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,OTHER,,,,,,,2024,0.0
NCT03347422,,2017-11-16,2022-12-01,,2022-12-01,2017-11-16,2017-11-20,ACTUAL,2022-12-01,2022-12-23,ACTUAL,,,,2022-12-01,2022-12-23,ACTUAL,2018-03-17,ACTUAL,2018-03-17,2022-12,2022-12-31,2021-12-03,ACTUAL,2021-12-03,2021-12-03,ACTUAL,2021-12-03,,INTERVENTIONAL,Cadenza,Analysis was performed on full analysis set (FAS) which included all randomized participants who received at least 1 dose (including partial dose) of study drug (BIVV009 or placebo).,A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion,"A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion",COMPLETED,,PHASE3,42.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,INDUSTRY,,,,,,,2021,1.0
NCT03763760,,2018-11-28,,,2021-06-29,2018-12-03,2018-12-04,ACTUAL,,,,,,,2021-06-29,2021-06-30,ACTUAL,2019-01-29,ACTUAL,2019-01-29,2021-06,2021-06-30,2021-01-01,ACTUAL,2021-01-01,2021-01-01,ACTUAL,2021-01-01,,INTERVENTIONAL,,,High-Dose Steroid for Hip Arthroplasty Patients Expected to Have Postoperative Pain,High-Dose Steroids in High Pain Responders Undergoing Total Hip-arthroplasty: A Randomized Double Blinded Controlled Trial,COMPLETED,,PHASE4,160.0,ACTUAL,"Copenhagen University Hospital, Hvidovre",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,OTHER,,,,,,,2021,0.0
NCT03672175,,2018-09-12,2022-10-15,2020-10-15,2023-11-27,2018-09-12,2018-09-14,ACTUAL,2022-10-15,2022-11-10,ACTUAL,2020-10-15,2020-10-22,ACTUAL,2023-11-27,2023-11-29,ACTUAL,2018-11-19,ACTUAL,2018-11-19,2023-11,2023-11-30,2020-03-17,ACTUAL,2020-03-17,2019-09-24,ACTUAL,2019-09-24,,INTERVENTIONAL,,Safety Set included all participants who were administered IP.,A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder,"A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of SAGE-217 in the Treatment of Adult Subjects With Major Depressive Disorder",COMPLETED,,PHASE3,581.0,ACTUAL,Biogen,,3.0,,,f,,,,f,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2020,1.0
NCT03095404,,2017-02-21,,,2021-10-01,2017-03-23,2017-03-29,ACTUAL,,,,,,,2021-10-01,2021-10-08,ACTUAL,2021-09,ESTIMATED,2021-09-30,2021-10,2021-10-31,2022-02-28,ESTIMATED,2022-02-28,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery,Optimum Dosage of Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,McMaster University,,2.0,,No funding available.,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,OTHER,,,,,,,2022,0.0
NCT02394795,,2015-03-16,2023-01-12,,2023-01-12,2015-03-19,2015-03-20,ESTIMATED,2023-01-12,2023-11-01,ACTUAL,,,,2023-01-12,2023-11-01,ACTUAL,2015-05-29,ACTUAL,2015-05-29,2023-01,2023-01-31,2022-01-14,ACTUAL,2022-01-14,2022-01-14,ACTUAL,2022-01-14,,INTERVENTIONAL,PARADIGM,Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without major protocol deviation.,"Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC","A Phase III, Randomized, Controlled Study of mFOLFOX6 + Bevacizumab Combination Therapy Versus mFOLFOX6 + Panitumumab Combination Therapy in Chemotherapy-naive Patients With KRAS/NRAS Wild-type, Incurable/Unresectable, Advanced/Recurrent Colorectal Cancer",COMPLETED,,PHASE3,823.0,ACTUAL,Takeda,,2.0,,,f,,,,f,f,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,INDUSTRY,,,,,,,2022,1.0
NCT03720574,,2018-10-24,,,2022-04-29,2018-10-24,2018-10-25,ACTUAL,,,,,,,2022-04-29,2022-05-02,ACTUAL,2019-09-17,ACTUAL,2019-09-17,2022-04,2022-04-30,2020-12-12,ACTUAL,2020-12-12,2020-12-06,ACTUAL,2020-12-06,,INTERVENTIONAL,,,Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Obese Patients,"Efficacy and Safety of Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Adult Obese Patients: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study",TERMINATED,,PHASE3,100.0,ACTUAL,"Kanion & Huawe Medicine Co.,Ltd",,2.0,,Reassess safety risks and benefits,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,INDUSTRY,,,,,,,2020,0.0
NCT04303377,,2020-03-06,,,2021-04-22,2020-03-10,2020-03-11,ACTUAL,,,,,,,2021-04-22,2021-04-26,ACTUAL,2019-11-18,ACTUAL,2019-11-18,2021-04,2021-04-30,2020-07-24,ACTUAL,2020-07-24,2020-01-02,ACTUAL,2020-01-02,,INTERVENTIONAL,ExOTIC,,Early Treatment With Evolocumab in Patients With ST-elevation Myocardial Infarction,Early Treatment With evOlocumab in Patients With sT-elevation Myocardial Infarction Undergoing Primary pCi (ExOTIC Study),WITHDRAWN,,PHASE2,0.0,ACTUAL,Fondazione IRCCS Policlinico San Matteo di Pavia,,2.0,,The sponsor required early termination of the economic agreement due to a supposed extension of the enrollment period for bureaucracy reasons and for the concomitant Covid -19 Pandemic,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,OTHER,,,,,,,2020,0.0
NCT02729805,,2015-06-28,,,2023-05-08,2016-03-31,2016-04-06,ESTIMATED,,,,,,,2023-05-08,2023-05-10,ACTUAL,2015-08-18,ACTUAL,2015-08-18,2023-05,2023-05-31,2024-06,ESTIMATED,2024-06-30,2024-06,ESTIMATED,2024-06-30,,INTERVENTIONAL,,,Intraoperative Ketamine on Chronic Pain After Mastectomy,Effects of Intraoperative Intravenous Ketamine on Chronic Pain After Mastectomy,SUSPENDED,,PHASE4,135.0,ESTIMATED,The University of Hong Kong,,3.0,,Not enough patients,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,OTHER,,,,,,,2024,0.0
NCT03565406,,2018-06-12,,,2020-05-19,2018-06-12,2018-06-21,ACTUAL,,,,,,,2020-05-19,2020-05-21,ACTUAL,2018-04-25,ACTUAL,2018-04-25,2020-05,2020-05-31,2020-01-13,ACTUAL,2020-01-13,2020-01-13,ACTUAL,2020-01-13,,INTERVENTIONAL,,,A Phase 1b Study of the Selective HDAC Inhibitor Mocetinostat in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma,A Phase 1b Study of the Selective HDAC Inhibitor Mocetinostat in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma,TERMINATED,,PHASE1,11.0,ACTUAL,NYU Langone Health,,1.0,,recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated,f,,,,f,t,f,,,,,,,,,,,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,OTHER,,,,,,,2020,0.0
NCT03864328,,2019-03-02,,,2020-06-08,2019-03-04,2019-03-06,ACTUAL,,,,,,,2020-06-08,2020-06-11,ACTUAL,2019-03-29,ACTUAL,2019-03-29,2020-06,2020-06-30,2020-06-05,ACTUAL,2020-06-05,2020-05-29,ACTUAL,2020-05-29,,INTERVENTIONAL,SCENIC,,A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF,"Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study With Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial",TERMINATED,,PHASE2,108.0,ACTUAL,Respivant Sciences Inc.,,4.0,,COVID-19 Pandemic,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,INDUSTRY,,,,,,,2020,0.0
NCT03920878,,2019-04-17,,,2020-12-23,2019-04-17,2019-04-19,ACTUAL,,,,,,,2020-12-23,2020-12-24,ACTUAL,2020-05,ESTIMATED,2020-05-31,2020-12,2020-12-31,2020-06,ESTIMATED,2020-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,Cataract DME - Peri vs. Intraop,Peri- Versus Intra-operative Anti-vascular Endothelial Growth Factor Intravitreous Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery,WITHDRAWN,,PHASE2,0.0,ACTUAL,Emory University,,2.0,,The study team was unable to secure sufficient funding and administrative support.,f,,,,t,t,f,,,f,,,,,,NO,No individual de-identified participant data (including data dictionaries) will be shared. Only composite results with publication will be shared.,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,OTHER,,,,,,,2020,0.0
NCT02486406,,2015-06-17,2021-09-07,,2021-09-07,2015-06-29,2015-07-01,ESTIMATED,2021-09-07,2021-10-05,ACTUAL,,,,2021-09-07,2021-10-05,ACTUAL,2015-10-28,ACTUAL,2015-10-28,2021-09,2021-09-30,2020-11-19,ACTUAL,2020-11-19,2020-11-19,ACTUAL,2020-11-19,,INTERVENTIONAL,ZIRCON,Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 or Part 2,A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects,"An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Ombitasvir (OBV), Paritaprevir (PTV), Ritonavir (RTV) With or Without Dasabuvir (DSV) and With or Without Ribavirin (RBV) in Pediatric Subjects With Genotype 1 or 4 Chronic Hepatitis C Virus (HCV) Infection (ZIRCON)",COMPLETED,,PHASE2/PHASE3,64.0,ACTUAL,AbbVie,,4.0,,,f,,,,f,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,INDUSTRY,,,,,,,2020,1.0
NCT05144347,,2021-11-10,,,2023-07-07,2021-11-22,2021-12-03,ACTUAL,,,,,,,2023-07-07,2023-07-11,ACTUAL,2022-04-12,ACTUAL,2022-04-12,2023-07,2023-07-31,2022-11-01,ACTUAL,2022-11-01,2022-11-01,ACTUAL,2022-11-01,,INTERVENTIONAL,,,Study of XL114 in Subjects With Non-Hodgkin's Lymphoma,A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL114 Administered in Subjects With Non-Hodgkin's Lymphoma,TERMINATED,,PHASE1,2.0,ACTUAL,Exelixis,,2.0,,Due to Sponsor reasons.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,INDUSTRY,,,,,,,2022,0.0
NCT03512262,,2018-04-17,2022-11-14,,2023-04-06,2018-04-26,2018-04-30,ACTUAL,2023-04-06,2023-04-07,ACTUAL,,,,2023-04-06,2023-04-07,ACTUAL,2018-05-03,ACTUAL,2018-05-03,2023-04,2023-04-30,2021-09-08,ACTUAL,2021-09-08,2021-08-17,ACTUAL,2021-08-17,,INTERVENTIONAL,,ITT Population: All participants randomized into the study.,Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM),"A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis",COMPLETED,,PHASE3,228.0,ACTUAL,"Radius Health, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,INDUSTRY,,,,,,,2021,1.0
NCT04539483,,2020-08-31,,,2023-09-21,2020-08-31,2020-09-07,ACTUAL,,,,,,,2023-09-21,2023-09-25,ACTUAL,2020-10-08,ACTUAL,2020-10-08,2023-09,2023-09-30,2023-05-31,ACTUAL,2023-05-31,2023-05-31,ACTUAL,2023-05-31,,INTERVENTIONAL,MATCH-1,,Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection,"A Randomised, Double-Blind Phase II Trial of Topical HDIT101 Versus Placebo in Patients With Chronic Recurrent HSV-1 Infection and Orolabial Lesion",TERMINATED,,PHASE2,761.0,ACTUAL,Heidelberg ImmunoTherapeutics GmbH,,2.0,,stopped for futility in interim analysis,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2023,0.0
NCT02566993,,2015-09-24,2021-08-06,,2021-09-29,2015-10-01,2015-10-02,ESTIMATED,2021-09-29,2021-10-28,ACTUAL,,,,2021-09-29,2021-10-28,ACTUAL,2016-08-30,ACTUAL,2016-08-30,2021-08,2021-08-31,2020-02-24,ACTUAL,2020-02-24,2020-02-24,ACTUAL,2020-02-24,,INTERVENTIONAL,ATLANTIS,,Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer,"Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus Cyclophosphamide, Doxorubicin and Vincristine (CAV) or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (SCLC) Who Failed One Prior Platinum-containing Line (ATLANTIS)",COMPLETED,,PHASE3,613.0,ACTUAL,PharmaMar,,3.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,INDUSTRY,,,,,,,2020,1.0
NCT05320380,,2022-03-22,,,2023-08-29,2022-04-01,2022-04-11,ACTUAL,,,,,,,2023-08-29,2023-09-01,ACTUAL,2023-08-01,ESTIMATED,2023-08-01,2023-02,2023-02-28,2023-09-01,ESTIMATED,2023-09-01,2023-09-01,ESTIMATED,2023-09-01,,INTERVENTIONAL,,,A Study of the Drug IMGN632 in Children With Leukemia That Has Come Back After Treatment or is Difficult to Treat,A PedAL/EuPAL Phase 1/2 Trial of IMGN632 in Pediatric Patients With Relapsed or Refractory Leukemia,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Children's Oncology Group,,4.0,,Withdrawn per CS0150757,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,NETWORK,,,,,,,2023,0.0
NCT05106335,,2021-10-22,,,2023-08-14,2021-10-22,2021-11-03,ACTUAL,,,,,,,2023-08-14,2023-08-16,ACTUAL,2022-01-06,ACTUAL,2022-01-06,2023-08,2023-08-31,2022-05-11,ACTUAL,2022-05-11,2022-05-11,ACTUAL,2022-05-11,,INTERVENTIONAL,,,A Study to Evaluate Camrelizumab Combined With Famitinib as Subsequent Therapy in Patients With Advanced NSCLC,"A Randomized, Open-Label, Controlled, Multi-Center Phase III Clinical Study of Camrelizumab Combined With Famitinib Malate Versus Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer Who Progressed on Prior Immune Checkpoint Inhibitor Treatment and Platinum-Based Chemotherapy",TERMINATED,,PHASE3,1.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,3.0,,Sponsor R \& D Strategy Adjustment,f,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,INDUSTRY,,,,,,,2022,0.0
NCT04518137,,2020-08-15,,,2023-01-30,2020-08-15,2020-08-19,ACTUAL,,,,,,,2023-01-30,2023-01-31,ACTUAL,2021-04-09,ACTUAL,2021-04-09,2023-01,2023-01-31,2022-05-30,ACTUAL,2022-05-30,2022-05-30,ACTUAL,2022-05-30,,INTERVENTIONAL,,,A Study of Evaluating the Safety and Efficacy of ATG-008 for Advanced Solid Tumors (BUNCH),"An Open-Label, Single-Arm Basket Study of ATG-008 for the Treatment of Patients With Advanced Solid Tumors Harboring NFE2L2, STK11, RICTOR or Other Specific Genetic Alterations",TERMINATED,,PHASE2,5.0,ACTUAL,Antengene Corporation,,1.0,,"Due to the low popularity of NGS testing in China and the small number of target subjects, our company decided to adjust the research and development strategy, terminate this study and not apply for new drug registration after careful consideration.",f,,,,f,f,f,,,,,,,,,,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,INDUSTRY,,,,,,,2022,0.0
NCT05372783,,2022-05-10,,,2023-02-09,2022-05-11,2022-05-13,ACTUAL,,,,,,,2023-02-09,2023-02-13,ACTUAL,2023-04,ESTIMATED,2023-04-30,2023-02,2023-02-28,2024-10,ESTIMATED,2024-10-31,2024-06,ESTIMATED,2024-06-30,,INTERVENTIONAL,,,Study to Evaluate the Efficacy of IN STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents,"A Randomized, Placebo-Controlled Trial to Evaluate the Efficacy of Intranasal STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,2.0,,Study was never launched,f,,,,,t,f,,,,,,,,,,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,INDUSTRY,,,,,,,2024,0.0
NCT04154150,,2019-11-04,2022-11-18,,2024-07-18,2019-11-04,2019-11-06,ACTUAL,2022-12-15,2023-01-10,ACTUAL,,,,2024-07-18,2024-07-22,ACTUAL,2019-12-19,ACTUAL,2019-12-19,2024-07,2024-07-31,2022-03-15,ACTUAL,2022-03-15,2022-03-15,ACTUAL,2022-03-15,,INTERVENTIONAL,,,Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot,Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot,TERMINATED,,PHASE4,16.0,ACTUAL,University of Pittsburgh,"Pilot study leading to small numbers of patients in each treatment arm. Descriptive statistics are reported without statistical analysis to directly compare groups, given the small number of patients within each group leading to low statistical power.",2.0,,"Midway through this pilot study, funding was obtained to support a much larger study of the same interventions in this clinical population. Therefore the pilot study was halted so as not to compete with enrollment for the larger study.",f,,,,,t,f,,,,,,,,,NO,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,OTHER,,,,,,,2022,0.0
NCT04460729,,2020-07-02,,,2020-12-01,2020-07-02,2020-07-08,ACTUAL,,,,,,,2020-12-01,2020-12-03,ACTUAL,2020-11-11,ESTIMATED,2020-11-11,2020-11,2020-11-30,2023-11-17,ESTIMATED,2023-11-17,2023-11-17,ESTIMATED,2023-11-17,,INTERVENTIONAL,,,"A Phase II, Open-Label, Multicenter Study of Capmatinib in Subjects With MET Exon 14 Skipping Mutation Positive, Advanced, NSCLC With Brain Metastases","A Phase II, Open-Label, Multicenter Study of Capmatinib in Subjects With MET Exon 14 Skipping Mutation Positive, Advanced, Non Small-Cell Lung Cancer That Has Metastasized to the Brain",WITHDRAWN,,PHASE2,0.0,ACTUAL,Novartis,,2.0,,company decision,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2023,0.0
NCT05053126,,2021-09-13,2023-04-17,,2023-07-21,2021-09-13,2021-09-22,ACTUAL,2023-07-21,2023-08-14,ACTUAL,,,,2023-07-21,2023-08-14,ACTUAL,2021-07-27,ACTUAL,2021-07-27,2023-07,2023-07-31,2022-04-01,ACTUAL,2022-04-01,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,,The randomized population included all participants who were randomized to a treatment sequence in the Treatment Phase,Study Evaluating Abuse Potential of Lyrica® in Healthy Non-Drug Dependent Recreational Opioid Users,A Phase 4 Randomized Double-Blind Double-Dummy Placebo & Active-Controlled Single-Dose Six-Way Crossover Study Evaluating the Abuse Potential of Lyrica® Taken Orally With Oxycodone HCL in Healthy Non-Drug Dependent Recreational Opioid Users,COMPLETED,,PHASE4,60.0,ACTUAL,Viatris Inc.,,6.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,INDUSTRY,,,,,,,2022,1.0
NCT03977974,,2019-06-05,,,2020-04-21,2019-06-05,2019-06-06,ACTUAL,,,,,,,2020-04-21,2020-04-22,ACTUAL,2019-06-21,ACTUAL,2019-06-21,2020-04,2020-04-30,2020-03-05,ACTUAL,2020-03-05,2020-03-05,ACTUAL,2020-03-05,,INTERVENTIONAL,,,A Study of LY3526318 in Healthy Participants,"A Safety, Tolerability, Pharmacokinetic, and Pilot Food Effect Study of Single- and Multiple-Ascending Doses of LY3526318 in Healthy Participants",TERMINATED,,PHASE1,76.0,ACTUAL,Eli Lilly and Company,,4.0,,COVID-19 pandemic.,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,INDUSTRY,,,,,,,2020,0.0
NCT04476628,,2020-07-14,,,2022-07-07,2020-07-14,2020-07-20,ACTUAL,,,,,,,2022-07-07,2022-07-11,ACTUAL,2021-02-01,ESTIMATED,2021-02-01,2022-07,2022-07-31,2022-02-28,ESTIMATED,2022-02-28,2022-01-31,ESTIMATED,2022-01-31,,INTERVENTIONAL,,,Efficacy of Budesonide Via Delayed Release vs Immediate Release,Prospective Double-Cohort Study: Comparing Efficacy of Budesonide Via Delayed Release vs Immediate Release After Administration in the Lying Head Back Position,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,"St. Paul's Hospital, Canada",,2.0,,"Due to COVID-19, we didn't start this study",f,,,,f,f,f,,,t,,,,,,NO,We will publish final outcomes as scientific paper.,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,OTHER,,,,,,,2022,0.0
NCT03950856,,2019-05-13,2021-03-16,,2021-03-16,2019-05-13,2019-05-15,ACTUAL,2021-03-16,2021-04-12,ACTUAL,,,,2021-03-16,2021-04-12,ACTUAL,2019-06-12,ACTUAL,2019-06-12,2021-03,2021-03-31,2020-04-03,ACTUAL,2020-04-03,2020-04-03,ACTUAL,2020-04-03,,INTERVENTIONAL,PNEU-TRUE,,Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020),"A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults 50 Years of Age or Older (PNEU-TRUE)",COMPLETED,,PHASE3,2340.0,ACTUAL,Merck Sharp & Dohme LLC,,4.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,INDUSTRY,,,,,,,2020,1.0
NCT02790034,,2016-05-24,2021-10-12,,2021-11-22,2016-05-30,2016-06-03,ESTIMATED,2021-11-22,2021-12-21,ACTUAL,,,,2021-11-22,2021-12-21,ACTUAL,2016-10-26,ACTUAL,2016-10-26,2021-11,2021-11-30,2020-05-04,ACTUAL,2020-05-04,2019-08-06,ACTUAL,2019-08-06,,INTERVENTIONAL,STARS,,"Evaluation of the Efficacy, Safety, and Tolerability of Sarizotan in Rett Syndrome With Respiratory Symptoms","A Randomised, Double-Blind, Placebo-Controlled 6-month Study to Evaluate the Efficacy, Safety, and Tolerability of Sarizotan in Patients With Rett Syndrome With Respiratory Symptoms",TERMINATED,,PHASE2/PHASE3,129.0,ACTUAL,Newron Pharmaceuticals SPA,"No efficacy evaluation was performed for the open label extension, as the study was terminated prematurely by the Sponsor based on lack of demonstrated efficacy in the double-blind period.",3.0,,The study did not demonstrate evidence of efficacy on the primary or secondary efficacy variables,f,,,,t,,,,,,,,,,,,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,INDUSTRY,,,,,,,2020,0.0
NCT03410927,,2018-01-19,,,2024-08-30,2018-01-19,2018-01-25,ACTUAL,,,,,,,2024-08-30,2024-09-05,ACTUAL,2018-04-06,ACTUAL,2018-04-06,2024-08,2024-08-31,2022-06-09,ACTUAL,2022-06-09,2022-06-09,ACTUAL,2022-06-09,,INTERVENTIONAL,,,A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities,"A Phase 1/2, Open Label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of TAS0728, an Oral Covalent Binding Inhibitor of HER2, in Subjects With Advanced Solid Tumors With HER2 or HER3 Abnormalities",TERMINATED,,PHASE1,19.0,ACTUAL,"Taiho Oncology, Inc.",,1.0,,The study was stopped due to unacceptable toxicity during the dose-escalation portion (Phase 1) of the study and did not progress to Phase 2,f,,,,f,t,f,,,,,,,,,,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,INDUSTRY,,,,,,,2022,0.0
NCT01296555,,2011-02-14,2022-06-22,,2024-02-13,2011-02-14,2011-02-15,ESTIMATED,2024-02-13,2024-07-31,ACTUAL,,,,2024-02-13,2024-07-31,ACTUAL,2011-03-16,ACTUAL,2011-03-16,2024-02,2024-02-29,2021-06-25,ACTUAL,2021-06-25,2021-06-25,ACTUAL,2021-06-25,,INTERVENTIONAL,,"The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.",A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer,"An Open-Label, Phase I/II, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer",TERMINATED,,PHASE1,674.0,ACTUAL,"Genentech, Inc.",,6.0,,The Sponsor discontinued the manufacturing and development of taselisib due to modest clinical benefit and limited tolerability.,f,,,,,t,f,,,,,,,,,,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2021,0.0
NCT03295695,,2017-09-25,,,2020-12-03,2017-09-25,2017-09-28,ACTUAL,,,,,,,2020-12-03,2020-12-04,ACTUAL,2020-12,ESTIMATED,2020-12-31,2020-12,2020-12-31,2022-12,ESTIMATED,2022-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient,Pilot Study of PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient Before and After Neoadjuvant Chemotherapy,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,1.0,,closure of radiolaboratory,f,,,,f,t,f,,,,,,,,,,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,OTHER,,,,,,,2022,0.0
NCT03347994,,2017-11-15,,,2018-03-03,2017-11-15,2017-11-20,ACTUAL,,,,,,,2018-03-03,2018-03-06,ACTUAL,2018-04,ESTIMATED,2018-04-30,2018-03,2018-03-31,2022-04,ESTIMATED,2022-04-30,2021-04,ESTIMATED,2021-04-30,,INTERVENTIONAL,,,Minnelide in Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia,"A Phase I Pilot Study of Minnelide, A Novel Heat Shock Protein 70 Inhibitor, in Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia",WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Miami,,4.0,,Discordance in contractual language and terms.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,OTHER,,,,,,,2022,0.0
NCT03431974,,2018-02-01,2023-03-18,,2023-03-18,2018-02-06,2018-02-13,ACTUAL,2023-03-18,2023-04-14,ACTUAL,,,,2023-03-18,2023-04-14,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2023-03,2023-03-31,2021-01-11,ACTUAL,2021-01-11,2021-01-11,ACTUAL,2021-01-11,,INTERVENTIONAL,,,Once-Weekly Oral Aminopterin for the Treatment of Subjects With Moderate-To-Severe Psoriasis,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial to Establish the Efficacy and Safety of Once-Weekly Oral Aminopterin for the Treatment of Subjects With Moderate-To-Severe Psoriasis",COMPLETED,,PHASE2,19.0,ACTUAL,"Syntrix Biosystems, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,INDUSTRY,,,,,,,2021,1.0
NCT03434028,,2018-02-09,2023-02-03,,2023-06-15,2018-02-09,2018-02-15,ACTUAL,2023-06-15,2023-07-06,ACTUAL,,,,2023-06-15,2023-07-06,ACTUAL,2018-03-07,ACTUAL,2018-03-07,2023-06,2023-06-30,2022-08-24,ACTUAL,2022-08-24,2022-05-10,ACTUAL,2022-05-10,,INTERVENTIONAL,CLOVERS,,Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis,Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis,COMPLETED,,PHASE3,1563.0,ACTUAL,Massachusetts General Hospital,"All cause mortality: To clarify, we did not classify death as anticipated or not anticipated; nor did we collect cause of death for this trial.",2.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,OTHER,,,,,,,2022,1.0
NCT01048138,,2010-01-12,,,2023-01-27,2010-01-12,2010-01-13,ESTIMATED,,,,,,,2023-01-27,2023-01-31,ACTUAL,2018-01-31,ACTUAL,2018-01-31,2023-01,2023-01-31,2022-12-02,ACTUAL,2022-12-02,2022-12-02,ACTUAL,2022-12-02,,INTERVENTIONAL,,,Use of Biperiden for the Prevention of Post-traumatic Epilepsy,"Use of Biperiden as a Disease Modifying Agent After Traumatic Brain Injury: a Placebo Controlled, Randomized, Double Blind Study",TERMINATED,,PHASE3,123.0,ACTUAL,Federal University of São Paulo,,2.0,,"Recruitment and funding issues, together with the event of the SARS-CoV-2 pandemic prompted an adjustment in the study design to stop enrollment at 123 patients.",f,,,,t,f,f,,,,,,,,,,,2024-10-15 12:12:57.600569,2024-10-15 12:12:57.600569,OTHER,,,,,,,2022,0.0
NCT03841526,,2019-02-12,2021-07-12,,2023-08-23,2019-02-12,2019-02-15,ACTUAL,2023-08-23,2023-08-25,ACTUAL,,,,2023-08-23,2023-08-25,ACTUAL,2019-08-22,ACTUAL,2019-08-22,2023-08,2023-08-31,2020-04-02,ACTUAL,2020-04-02,2020-04-02,ACTUAL,2020-04-02,,INTERVENTIONAL,,"Baseline information is presented for the Safety population for the CRC Phase (Period 1) of the study, this includes all randomized subjects who received at least one dose of study drug.",Glucagon Ready-to-Use (RTU) for Prevention of Exercise-Induced Hypoglycemia During Aerobic Exercise in Adults With T1D,Phase 2 Randomized Placebo-Controlled Double-Blind Parallel Study to Evaluate Glucagon RTU (Glucagon Injection) Compared to Standard of Care for Prevention of Exercise-Induced Hypoglycemia During Regular Aerobic Exercise in Adults With T1D,COMPLETED,,PHASE2,48.0,ACTUAL,Xeris Pharmaceuticals,,5.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,INDUSTRY,,,,,,,2020,1.0
NCT03482752,,2018-03-21,2023-03-24,,2024-01-18,2018-03-28,2018-03-29,ACTUAL,2024-01-18,2024-07-03,ACTUAL,,,,2024-01-18,2024-07-03,ACTUAL,2018-04-16,ACTUAL,2018-04-16,2024-01,2024-01-31,2021-01-14,ACTUAL,2021-01-14,2021-01-14,ACTUAL,2021-01-14,,INTERVENTIONAL,IMPALA-X,,Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis,"An Open-label, Non-controlled, Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis Patients",TERMINATED,,PHASE3,60.0,ACTUAL,Savara Inc.,"No hypothesis/statistical testing was planned for any of the endpoints of this study but only descriptive statistics were to be used. Efficacy endpoints were secondary endpoints. Due to early study termination, only limited efficacy data were available for evaluation and in general, no firm conclusion based on efficacy data are applicable. No deaths occurred during the study but 1 participant died due to COVID-19 24 days after last dose, i.e. outside the definition of 'treatment-emergent'.",1.0,,SAV006-03 was initiated before the evaluation of the IMPALA study (NCT02702180) results. Considering these results and authority advice there would not be adequate efficacy and safety data from SAV006-03 and the study was terminated.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2021,0.0
NCT04431219,,2020-05-28,,,2022-08-16,2020-06-10,2020-06-16,ACTUAL,,,,,,,2022-08-16,2022-08-17,ACTUAL,2019-11-26,ACTUAL,2019-11-26,2022-08,2022-08-31,2022-03-28,ACTUAL,2022-03-28,2022-03-28,ACTUAL,2022-03-28,,INTERVENTIONAL,,,"First in Human Study: LIS1, an Induction Treatment in Kidney Transplanted Patients","First in Human Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Multiple Ascending Intravenous Doses of LIS1 in Kidney Transplanted Patients",COMPLETED,,PHASE1/PHASE2,10.0,ACTUAL,Xenothera SAS,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2022,1.0
NCT03968198,,2019-05-14,,,2023-03-29,2019-05-27,2019-05-30,ACTUAL,,,,,,,2023-03-29,2023-03-31,ACTUAL,2020-03-04,ACTUAL,2020-03-04,2023-03,2023-03-31,2023-03-10,ACTUAL,2023-03-10,2023-03-10,ACTUAL,2023-03-10,,INTERVENTIONAL,ACellDREAM2,,Administration of Adipose-derived Stem Cells (ASC) in Patient With Critical Limb Ischemia.,Autologous Transplantation of Adipose Tissue Derived Mesenchymal Stroma/Stem Cells (ASC) in Patients With Critical Limb Ischemia.,TERMINATED,,PHASE2,2.0,ACTUAL,"University Hospital, Toulouse",,1.0,,organizational difficulties for the collection of adipose tissue and for the supply of the experimental drug,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,OTHER,,,,,,,2023,0.0
NCT02415556,,2015-03-23,2021-06-07,,2022-05-01,2015-04-13,2015-04-14,ESTIMATED,2021-09-16,2021-09-17,ACTUAL,,,,2022-05-01,2022-05-19,ACTUAL,2015-10-06,ACTUAL,2015-10-06,2022-05,2022-05-31,2020-05-31,ACTUAL,2020-05-31,2020-05-31,ACTUAL,2020-05-31,,INTERVENTIONAL,MemAID,"Of 244 randomized participants, 223 participants completed baseline assessment.",Memory Aid by Intranasal Insulin in Diabetes (MemAID),Memory Advancement by Intranasal Insulin in Type 2 Diabetes,COMPLETED,,PHASE2,289.0,ACTUAL,Beth Israel Deaconess Medical Center,,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,OTHER,,,,,,,2020,1.0
NCT04438382,,2020-06-09,2024-02-26,,2024-06-11,2020-06-16,2020-06-18,ACTUAL,2024-02-26,2024-03-26,ACTUAL,,,,2024-06-11,2024-06-13,ACTUAL,2021-01-07,ACTUAL,2021-01-07,2024-06,2024-06-30,2023-12-21,ACTUAL,2023-12-21,2023-12-21,ACTUAL,2023-12-21,,INTERVENTIONAL,,"Only one patient was enrolled on this study. Due to the concern on confidentiality, individual data is not reported due to confidentiality reasons.",Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis,Optimizing Immunosuppression for Steroid-Refractory Anti-PD-1/PD-L1 Pneumonitis,TERMINATED,,PHASE2,1.0,ACTUAL,Eastern Cooperative Oncology Group,"Only one patient was enrolled on this study. Due to the concern on confidentiality, individual data was not reported.",2.0,,Slow accrual,f,,,,t,t,f,,,t,,,,,,YES,Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,NETWORK,,,,,,,2023,0.0
NCT02478320,,2015-06-19,2023-05-10,,2023-07-11,2015-06-19,2015-06-23,ESTIMATED,2023-07-11,2023-07-17,ACTUAL,,,,2023-07-11,2023-07-17,ACTUAL,2016-08-05,ACTUAL,2016-08-05,2023-07,2023-07-31,2022-05-12,ACTUAL,2022-05-12,2022-05-12,ACTUAL,2022-05-12,,INTERVENTIONAL,,Part 2 Tumor-specific expansion (trial was terminated before this part was reached),Phase II Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient Solid Tumors,A Proof-of-Concept Study for Ilorasertib (ABT-348) Activity in Patients With CDKN2A-Deficient Advanced Solid Cancers: a Phase II Basket Trial,TERMINATED,,PHASE2,12.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Study terminated due to company's decision to discontinue drug development,f,,,,f,t,f,,,,,,,,,,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,OTHER,,,,,,,2022,0.0
NCT03285308,,2017-09-14,2021-07-08,,2021-07-08,2017-09-14,2017-09-18,ACTUAL,2021-07-08,2021-07-29,ACTUAL,,,,2021-07-08,2021-07-29,ACTUAL,2017-09-29,ACTUAL,2017-09-29,2021-07,2021-07-31,2020-07-08,ACTUAL,2020-07-08,2020-07-08,ACTUAL,2020-07-08,,INTERVENTIONAL,,ITT Population included all randomized participants.,A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01,"A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis",TERMINATED,,PHASE3,336.0,ACTUAL,Allergan,,2.0,,The Relamorelin program is being terminated solely based on a business decision.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,INDUSTRY,,,,,,,2020,0.0
NCT05009732,,2021-08-16,,,2023-08-14,2021-08-16,2021-08-17,ACTUAL,,,,,,,2023-08-14,2023-08-18,ACTUAL,2021-09-30,ACTUAL,2021-09-30,2023-08,2023-08-31,2023-07-14,ACTUAL,2023-07-14,2023-02-06,ACTUAL,2023-02-06,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects,"A Randomized, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects",TERMINATED,,PHASE3,139.0,ACTUAL,"Suzhou Kintor Pharmaceutical Inc,",,2.0,,Sponsor's decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,INDUSTRY,,,,,,,2023,0.0
NCT03192969,,2017-06-14,,,2017-07-10,2017-06-19,2017-06-20,ACTUAL,,,,,,,2017-07-10,2017-07-12,ACTUAL,2017-07-15,ESTIMATED,2017-07-15,2017-07,2017-07-31,2021-11-23,ESTIMATED,2021-11-23,2020-06-07,ESTIMATED,2020-06-07,,INTERVENTIONAL,,,A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA),"A Phase III Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Combination With Glucocorticoid Treatment Compared to Glucocorticoid Monotherapy in Adults With Giant Cell Arteritis",WITHDRAWN,,PHASE3,0.0,ACTUAL,Bristol-Myers Squibb,,3.0,,Business objectives have changed,f,,,,t,t,f,,,,,,,,,,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2021,0.0
NCT05101915,,2021-09-13,,,2024-05-08,2021-10-21,2021-11-01,ACTUAL,,,,,,,2024-05-08,2024-05-10,ACTUAL,2021-11-01,ACTUAL,2021-11-01,2024-05,2024-05-31,2024-04-23,ACTUAL,2024-04-23,2024-01-31,ACTUAL,2024-01-31,,INTERVENTIONAL,NOMAB,,Study of a Nebulised Nitric Oxide Generating Solution in Patients With Mycobacterium Abscessus,Phase II Open Label Study of a Nebulised Nitric Oxide Generating Solution in Patients With Mycobacterium Abscessus Pulmonary Disease,TERMINATED,,PHASE2,6.0,ACTUAL,Papworth Hospital NHS Foundation Trust,,1.0,,TSC recommended early termination due to lack of futility of the trial.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,OTHER_GOV,,,,,,,2024,0.0
NCT04699968,,2021-01-05,,,2023-06-05,2021-01-05,2021-01-07,ACTUAL,,,,,,,2023-06-05,2023-06-07,ACTUAL,2021-01-15,ESTIMATED,2021-01-15,2023-06,2023-06-30,2021-11-15,ESTIMATED,2021-11-15,2021-11-15,ESTIMATED,2021-11-15,,INTERVENTIONAL,,,A Trial of SHR-1701 With or Without Famitinib in Patients With Advanced or Metastatic NSCLC,Phase II Clinical Trial of SHR-1701 With or Without Famitinib in the Treatment of Advanced or Metastatic NSCLC,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,2.0,,Sponsor R \& D Strategy Adjustment,f,,,,,f,f,,,,,,,,,,,2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2021,0.0
NCT03722472,,2018-10-25,2023-05-05,,2023-05-05,2018-10-25,2018-10-29,ACTUAL,2023-05-05,2023-06-01,ACTUAL,,,,2023-05-05,2023-06-01,ACTUAL,2018-10-02,ACTUAL,2018-10-02,2023-05,2023-05-31,2020-06-15,ACTUAL,2020-06-15,2020-06-15,ACTUAL,2020-06-15,,INTERVENTIONAL,,"males and females, ages 18-55 inclusive",Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults,"A Phase 1, Double-Blind, Randomized Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Single-Vial Lyophilized ID93 + GLA-SE Vaccine Administered Intramuscularly in Healthy Adult Subjects",COMPLETED,,PHASE1,48.0,ACTUAL,Access to Advanced Health Institute (AAHI),,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,OTHER,,,,,,,2020,1.0
NCT00533949,,2007-09-20,2017-01-17,,2022-05-23,2007-09-20,2007-09-24,ESTIMATED,2017-03-23,2017-05-05,ACTUAL,,,,2022-05-23,2022-06-21,ACTUAL,2007-11,,2007-11-30,2022-05,2022-05-31,2022-05-20,ACTUAL,2022-05-20,2013-06,ACTUAL,2013-06-30,,INTERVENTIONAL,,All eligible patients who did not withdraw consent.,High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery,A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer,COMPLETED,,PHASE3,544.0,ACTUAL,Radiation Therapy Oncology Group,"Cetuximab arms were added after the study opened, therefore the first 34 patients were excluded from cetuximab analysis. High dose RT arms closed early (at n=474), therefore later patients enrolled to low dose RT arm were excluded from RT analysis.",4.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,NETWORK,,,,,,,2022,1.0
NCT03569475,,2018-06-15,2022-03-01,,2022-03-01,2018-06-15,2018-06-26,ACTUAL,2022-03-01,2022-03-25,ACTUAL,,,,2022-03-01,2022-03-25,ACTUAL,2018-07-06,ACTUAL,2018-07-06,2022-03,2022-03-31,2021-03-01,ACTUAL,2021-03-01,2021-03-01,ACTUAL,2021-03-01,,INTERVENTIONAL,,Safety Population included all participants in the Randomized Population who received at least 1 dose of double-blind investigational product.,"Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder","A Double-blind, Placebo- and Active-controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Pediatric Patients 7-17 Years With Major Depressive Disorder",COMPLETED,,PHASE3,501.0,ACTUAL,Allergan,,3.0,,,f,,,,t,t,f,,,,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 22:59:19.986637,2024-10-15 22:59:19.986637,INDUSTRY,,,,,,,2021,1.0
NCT02816437,,2016-06-10,,,2020-05-21,2016-06-24,2016-06-28,ESTIMATED,,,,,,,2020-05-21,2020-05-26,ACTUAL,2016-07,,2016-07-31,2020-05,2020-05-31,2022-12,ESTIMATED,2022-12-31,2022-10,ESTIMATED,2022-10-31,,INTERVENTIONAL,FMT,,FMT for MDRO Colonization in Solid Organ Transplant,Fecal Microbiota Transplantation for the Treatment of Multidrug-Resistant Organism Colonization in Solid Organ Transplant Recipients,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Miami,,1.0,,safety,f,,,,f,,,,,,,,,,,NO,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,OTHER,,,,,,,2022,0.0
NCT05056727,,2021-09-01,,,2024-06-07,2021-09-14,2021-09-24,ACTUAL,,,,,,,2024-06-07,2024-06-10,ACTUAL,2021-09-30,ACTUAL,2021-09-30,2024-06,2024-06-30,2024-02-07,ACTUAL,2024-02-07,2024-02-07,ACTUAL,2024-02-07,,INTERVENTIONAL,STABILIZE-CKD,,A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia,"A Phase 3, International, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on CKD Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia",TERMINATED,,PHASE3,716.0,ACTUAL,AstraZeneca,,2.0,,The study started enrollment in Sep 2021 and despite huge efforts the rate of patient enrollment continued to be below target such that the completion of the study within a reasonable timeframe was deemed very unlikely.,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,INDUSTRY,,,,,,,2024,0.0
NCT06460194,,2019-03-14,,,2024-06-10,2024-06-10,2024-06-14,ACTUAL,,,,,,,2024-06-10,2024-06-14,ACTUAL,2022-11,ESTIMATED,2022-11-30,2024-06,2024-06-30,2024-06-10,ACTUAL,2024-06-10,2023-07,ESTIMATED,2023-07-31,,INTERVENTIONAL,,,Treatment of Frostbite Sequelae With Botulinum Toxin A,"Botulinum Toxin A in the Treatment of Frostbite Sequelae - a Randomized, Double Blind, Placebo-controlled Study",WITHDRAWN,,PHASE2,0.0,ACTUAL,University Hospital of North Norway,,2.0,,No Participants Enrolled.,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,OTHER,,,,,,,2024,0.0
NCT05399550,,2022-05-27,,,2023-08-03,2022-05-27,2022-06-01,ACTUAL,,,,,,,2023-08-03,2023-08-07,ACTUAL,2022-06-22,ACTUAL,2022-06-22,2023-08,2023-08-31,2022-11-17,ACTUAL,2022-11-17,2022-11-17,ACTUAL,2022-11-17,,INTERVENTIONAL,,,Study to Evaluate The Safety and Efficacy of Balovaptan in Participants With Acute Ischemic Stroke at a High Risk of Developing Malignant Brain Edema,"A Phase II, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate The Safety and Efficacy of Balovaptan in Patients With Acute Ischemic Stroke at High Risk of Developing Malignant Cerebral Edema",WITHDRAWN,,PHASE2,0.0,ACTUAL,Hoffmann-La Roche,,2.0,,Sponsor's decision,f,,,,,t,f,,,,,,,,,,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,INDUSTRY,,,,,,,2022,0.0
NCT02946996,,2016-10-18,,,2024-08-19,2016-10-26,2016-10-27,ESTIMATED,,,,,,,2024-08-19,2024-08-21,ACTUAL,2016-12-28,ACTUAL,2016-12-28,2024-08,2024-08-31,2024-08-19,ACTUAL,2024-08-19,2023-12-05,ACTUAL,2023-12-05,,INTERVENTIONAL,,,Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy,Randomized Phase II Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy,TERMINATED,,PHASE2,41.0,ACTUAL,Medical University of South Carolina,,1.0,,Investigator retired from clinical practice prior to enrollment goal being met.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-14 21:45:37.159259,2024-10-14 21:45:37.159259,OTHER,,,,,,,2024,0.0
NCT04784455,,2020-11-19,,,2024-07-15,2021-03-04,2021-03-05,ACTUAL,,,,,,,2024-07-15,2024-07-16,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2024-06,2024-06-30,2024-05-15,ACTUAL,2024-05-15,2024-05-15,ACTUAL,2024-05-15,,INTERVENTIONAL,,,Nomacopan (rVA576) in Transplant Associated Thrombotic Microangiopathy,Multicentre Study of Nomacopan (rVA576) in Paediatric Haematopoietic Stem-Cell Transplant Associated Thrombotic Microangiopathy,TERMINATED,,PHASE3,10.0,ACTUAL,AKARI Therapeutics,,1.0,,"The early termination of this study is a business decision following a portfolio reprioritization plan. The decision is not related to any Efficacy, Safety or Clinical concerns regarding Nomacopan/rVA576",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,INDUSTRY,,,,,,,2024,0.0
NCT04477993,,2020-07-13,,,2021-04-05,2020-07-17,2020-07-20,ACTUAL,,,,,,,2021-04-05,2021-04-08,ACTUAL,2020-08-14,ACTUAL,2020-08-14,2021-04,2021-04-30,2021-03-29,ACTUAL,2021-03-29,2021-03-29,ACTUAL,2021-03-29,,INTERVENTIONAL,RUXO-COVID,,Ruxolitinib for Acute Respiratory Disorder Syndrome Due to COVID-19,"Randomized, Double-Blind Clinical Trial of Ruxolitinib in Patients With Acute Respiratory Disorder Syndrome Due to SARS-CoV-2 Infection",TERMINATED,,PHASE2/PHASE3,5.0,ACTUAL,University of Sao Paulo General Hospital,,2.0,,Low accrual,f,,,,t,f,f,,,,,,,,,,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,OTHER,,,,,,,2021,0.0
NCT03616964,,2018-08-01,2022-09-11,,2022-11-01,2018-08-01,2018-08-06,ACTUAL,2022-11-01,2022-11-23,ACTUAL,,,,2022-11-01,2022-11-23,ACTUAL,2018-08-02,ACTUAL,2018-08-02,2022-11,2022-11-30,2021-10-20,ACTUAL,2021-10-20,2021-09-24,ACTUAL,2021-09-24,,INTERVENTIONAL,BRAVE II,All randomized participants who received at least one dose of study drug.,A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE-BRAVE II),"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus",COMPLETED,,PHASE3,778.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,INDUSTRY,,,,,,,2021,1.0
NCT02939014,,2016-10-18,2019-07-23,,2021-02-03,2016-10-18,2016-10-19,ESTIMATED,2019-07-23,2019-09-06,ACTUAL,,,,2021-02-03,2021-02-24,ACTUAL,2016-11-07,ACTUAL,2016-11-07,2021-02,2021-02-28,2020-02-03,ACTUAL,2020-02-03,2018-08-02,ACTUAL,2018-08-02,,INTERVENTIONAL,,Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.,Brentuximab Vedotin in Chinese Participants With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL),"A Phase 2, Single-Arm, Open-label Study of Brentuximab Vedotin in Chinese Patients With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)",COMPLETED,,PHASE2,39.0,ACTUAL,Takeda,,1.0,,,f,,,,f,f,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,INDUSTRY,,,,,,,2020,1.0
NCT03179410,,2017-06-05,2020-12-16,,2021-02-12,2017-06-06,2017-06-07,ACTUAL,2021-02-12,2021-03-05,ACTUAL,,,,2021-02-12,2021-03-05,ACTUAL,2018-02-01,ACTUAL,2018-02-01,2021-02,2021-02-28,2020-12-18,ACTUAL,2020-12-18,2020-01-09,ACTUAL,2020-01-09,,INTERVENTIONAL,PICK-NEPC,,PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer,PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer,COMPLETED,,PHASE2,15.0,ACTUAL,Duke University,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,OTHER,,,,,,,2020,0.0
NCT04209205,,2019-10-30,2023-05-08,2022-10-04,2024-04-23,2019-12-19,2019-12-24,ACTUAL,2024-04-23,2024-04-26,ACTUAL,,2024-04-26,ACTUAL,2024-04-23,2024-04-26,ACTUAL,2020-01-29,ACTUAL,2020-01-29,2023-08,2023-08-31,2022-05-17,ACTUAL,2022-05-17,2022-05-17,ACTUAL,2022-05-17,,INTERVENTIONAL,INVIGORATE 2,Randomized set,"Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis","A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Psoriatic Arthritis",COMPLETED,,PHASE3,381.0,ACTUAL,Novartis,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,INDUSTRY,,,,,,,2022,1.0
NCT04333147,,2020-03-27,2023-11-28,,2024-01-12,2020-04-01,2020-04-03,ACTUAL,2024-01-12,2024-02-07,ACTUAL,,,,2024-01-12,2024-02-07,ACTUAL,2020-05-12,ACTUAL,2020-05-12,2024-01,2024-01-31,2023-02-24,ACTUAL,2023-02-24,2023-02-24,ACTUAL,2023-02-24,,INTERVENTIONAL,contRAst X,One participant withdrew from 150mg GSK3196165 before receiving intervention due to Physician Decision. Hence the participant was removed from intent-to-treat (ITT) and safety population (N=1459).,Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA),A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis,TERMINATED,,PHASE3,2916.0,ACTUAL,GlaxoSmithKline,,2.0,,Study is early terminated due to Limited efficacy demonstrated in the contRAst program does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. GSK has decided not to progress with regulatory submissions.,f,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,INDUSTRY,,,,,,,2023,0.0
NCT01828099,,2013-04-03,2017-06-23,,2024-01-22,2013-04-09,2013-04-10,ESTIMATED,2017-08-24,2017-09-21,ACTUAL,,,,2024-01-22,2024-01-24,ACTUAL,2013-07-09,ACTUAL,2013-07-09,2024-01,2024-01-31,2024-01-07,ACTUAL,2024-01-07,2016-06-24,ACTUAL,2016-06-24,,INTERVENTIONAL,,"The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment and strata to which they had been assigned during the randomization procedure.",LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer,"A Phase III Multicenter, Randomized Study of Oral LDK378 Versus Standard Chemotherapy in Previously Untreated Adult Patients With ALK Rearranged (ALK-positive), Stage IIIB or IV, Non-squamous Non-small Cell Lung Cancer",COMPLETED,,PHASE3,376.0,ACTUAL,Novartis,"Among the 187 patients randomized to chemotherapy arm, 12 patients were not treated.",2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,INDUSTRY,,,,,,,2024,1.0
NCT02573324,,2015-09-28,2023-03-23,,2023-05-08,2015-10-08,2015-10-09,ESTIMATED,2023-05-08,2023-05-11,ACTUAL,,,,2023-05-08,2023-05-11,ACTUAL,2015-01-04,ACTUAL,2015-01-04,2023-05,2023-05-31,2022-04-04,ACTUAL,2022-04-04,2022-04-04,ACTUAL,2022-04-04,,INTERVENTIONAL,Intellance1,,A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification,"A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)",COMPLETED,,PHASE3,691.0,ACTUAL,AbbVie,,3.0,,,t,,,,t,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,INDUSTRY,,NCT03123952,NO_LONGER_AVAILABLE,,,,2022,1.0
NCT04505878,,2020-08-05,,,2023-04-27,2020-08-05,2020-08-10,ACTUAL,,,,,,,2023-04-27,2023-05-01,ACTUAL,2023-04,ESTIMATED,2023-04-30,2023-04,2023-04-30,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Perioperative Vitamin C Lung Transplant,Vitamin C: Assessing Safety After Lung Transplant,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of Wisconsin, Madison",,1.0,,Decided not to proceed with study,f,,,,t,t,f,,,,,,up to 7 years after the completion of the primary endpoint,,,YES,"Data from this study may be requested from other researchers up to 7 years after the completion of the primary endpoint by contacting Dr. Micah Long, the Principal Investigator of this study.",2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,OTHER,,,,,,,2023,0.0
NCT04934670,,2021-06-14,2024-03-10,,2024-08-22,2021-06-14,2021-06-22,ACTUAL,2024-08-22,2024-08-27,ACTUAL,,,,2024-08-22,2024-08-27,ACTUAL,2022-06-16,ACTUAL,2022-06-16,2022-04,2022-04-30,2023-01-19,ACTUAL,2023-01-19,2022-11-10,ACTUAL,2022-11-10,,INTERVENTIONAL,2002,"A sample size of 246 participants was planned for this study with a 24-participant safety run-in. However, the study was stopped early after enrollment of 12 participants. Of these participants, 7 were randomized to T-Guard and 5 to ruxolitinib treatment.",A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002),"A Phase 3, Randomized, Open-Label, Multicenter Study, to Compare T-Guard to Ruxolitinib for the Treatment of Patients With Grade III or IV Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)",TERMINATED,,PHASE3,12.0,ACTUAL,Xenikos,"Early termination leading to small numbers of subjects analyzed, which resulted in the preparation and submission to the FDA and European authorities of an abbreviated clinical study report that did not contain all the outcome measures as specified in the clinical protocol.",2.0,,The study met the protocol defined stopping boundary for Day 60 mortality when comparing mortality between the T-Guard and ruxolitinib arms,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,INDUSTRY,,,,,,,2023,0.0
NCT05063734,,2021-09-08,2023-06-29,,2023-07-25,2021-09-21,2021-10-01,ACTUAL,2023-07-25,2023-08-18,ACTUAL,,,,2023-07-25,2023-08-18,ACTUAL,2021-08-27,ACTUAL,2021-08-27,2023-07,2023-07-31,2022-06-29,ACTUAL,2022-06-29,2022-06-29,ACTUAL,2022-06-29,,INTERVENTIONAL,INTEGRAL,,A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema.,"A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-687 Injections and to Evaluate the Efficacy and Safety of THR-687 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)",TERMINATED,,PHASE2,16.0,ACTUAL,Oxurion,"Based on data obtained in Part A, there was insufficient evidence of efficacy on the key outcome measures. As a result, the study was not advanced to Part B",6.0,,"Based on data obtained in Part A, there was insufficient evidence of efficacy on the key outcome measures. As a result, the study was not advanced to Part B.",f,,,,,t,f,,,,,,,,,NO,,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,INDUSTRY,,,,,,,2022,0.0
NCT00497926,,2007-07-06,,,2023-10-10,2007-07-06,2007-07-09,ESTIMATED,,,,,,,2023-10-10,2023-10-11,ACTUAL,2008-03,ACTUAL,2008-03-31,2023-10,2023-10-31,2023-04,ACTUAL,2023-04-30,2023-03,ACTUAL,2023-03-31,,INTERVENTIONAL,,,Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion,Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion,TERMINATED,,PHASE2,37.0,ACTUAL,Talaris Therapeutics Inc.,,1.0,,living donor kidney program terminated due to slow pace of phase 3 study enrollment,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,INDUSTRY,,,,,,,2023,0.0
NCT02606136,,2015-11-04,2021-11-30,,2024-07-31,2015-11-13,2015-11-17,ESTIMATED,2021-11-30,2021-12-30,ACTUAL,,,,2024-07-31,2024-08-27,ACTUAL,2016-01-04,ACTUAL,2016-01-04,2024-07,2024-07-31,2023-08-09,ACTUAL,2023-08-09,2020-05-07,ACTUAL,2020-05-07,,INTERVENTIONAL,MISSION,Intent-to-treat (ITT) population included all participants who enrolled in the study.,"Trial of Pamrevlumab (FG-3019), in Non-Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)","Trial of Pamrevlumab (FG-3019), a Monoclonal Antibody to Connective Tissue Growth Factor, in Non-Ambulatory Subjects With Duchenne Muscular Dystrophy",TERMINATED,,PHASE2,21.0,ACTUAL,FibroGen,,1.0,,Sponsor Decision,f,,,,t,t,,,,,,,,,,UNDECIDED,,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,INDUSTRY,,,,,,,2023,0.0
NCT03138512,,2017-05-01,,,2024-02-12,2017-05-01,2017-05-03,ACTUAL,,,,,,,2024-02-12,2024-02-13,ACTUAL,2017-07-07,ACTUAL,2017-07-07,2024-02,2024-02-29,2024-02-01,ACTUAL,2024-02-01,2023-09-12,ACTUAL,2023-09-12,,INTERVENTIONAL,CheckMate 914,,"A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney","A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse",COMPLETED,,PHASE3,1653.0,ACTUAL,Bristol-Myers Squibb,,5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,INDUSTRY,,,,,,,2024,0.0
NCT03399448,,2017-12-20,,,2023-06-20,2018-01-08,2018-01-16,ACTUAL,,,,,,,2023-06-20,2023-06-22,ACTUAL,2018-09-05,ACTUAL,2018-09-05,2020-10,2020-10-31,2020-10-09,ACTUAL,2020-10-09,2020-02-29,ACTUAL,2020-02-29,,INTERVENTIONAL,,,NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells),Phase 1 Trial of Autologous T Cells Engineered to Express NY-ESO-1 TCR and CRISPR Gene Edited to Eliminate Endogenous TCR and PD-1 (NYCE T Cells),TERMINATED,,PHASE1,3.0,ACTUAL,University of Pennsylvania,,3.0,,Sponsor has terminated trial to pursue other targets.,,,,,t,t,t,t,,,,,,,,UNDECIDED,,2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,OTHER,,,,,,,2020,0.0
NCT04158349,,2019-11-04,,,2021-09-21,2019-11-06,2019-11-08,ACTUAL,,,,,,,2021-09-21,2021-09-27,ACTUAL,2021-03-22,ACTUAL,2021-03-22,2021-09,2021-09-30,2021-05-14,ACTUAL,2021-05-14,2021-05-14,ACTUAL,2021-05-14,,INTERVENTIONAL,IPOX-FOLFIRI,,Intraperitoneal Oxaliplatin in Combo w IV mFOLFIRI for Peritoneal Carcinomatosis From Colorectal & Appendiceal Cancer,Phase I Trial of Intraperitoneal Oxaliplatin in Combination With Intravenous mFOLFIRI for Peritoneal Carcinomatosis From Colorectal and Appendiceal Cancer,TERMINATED,,PHASE1,1.0,ACTUAL,University of Utah,,3.0,,PI Decision,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,OTHER,,,,,,,2021,0.0
NCT05032521,,2021-08-27,,,2024-02-27,2021-08-27,2021-09-02,ACTUAL,,,,,,,2024-02-27,2024-02-28,ACTUAL,2021-11-02,ACTUAL,2021-11-02,2024-02,2024-02-29,2023-11-30,ACTUAL,2023-11-30,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,LACTEL,,Treatment of Hyperlactatemia in Acute Circulatory Failure Based on Analysis of CO2: a Prospective Randomized Superiority Study (The LACTEL Study),Treatment of Hyperlactatemia in Acute Circulatory Failure Based on Analysis of CO2: a Prospective Randomized Superiority Study (The LACTEL Study),COMPLETED,,PHASE4,180.0,ACTUAL,Centre Hospitalier Universitaire Dijon,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 18:15:11.353545,2024-10-16 18:15:11.353545,OTHER,,,,,,,2023,1.0
NCT02354547,,2014-12-18,,,2022-02-07,2015-01-29,2015-02-03,ESTIMATED,,,,,,,2022-02-07,2022-02-08,ACTUAL,2014-12,,2014-12-31,2022-02,2022-02-28,2023-12,ESTIMATED,2023-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,A Study of SGT-53 in Children With Refractory or Recurrent Solid Tumors,"A Phase I Study of SGT-53, a TfRscFv-Liposome-p53 Complex, in Children With Refractory or Recurrent Solid Tumors",SUSPENDED,,PHASE1,18.0,ESTIMATED,"SynerGene Therapeutics, Inc.",,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,INDUSTRY,,,,,,,2023,0.0
NCT02706847,,2016-02-18,2019-09-13,2018-02-05,2023-01-12,2016-03-08,2016-03-11,ESTIMATED,2019-09-13,2019-10-07,ACTUAL,2018-02-05,2018-02-09,ACTUAL,2023-01-12,2023-02-08,ACTUAL,2016-03-15,ACTUAL,2016-03-15,2023-01,2023-01-31,2022-02-08,ACTUAL,2022-02-08,2017-04-03,ACTUAL,2017-04-03,,INTERVENTIONAL,SELECT-BEYOND,The full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug. The 2 placebo groups were combined for analysis of data through Week 12.,A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs,"A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)",COMPLETED,,PHASE3,499.0,ACTUAL,AbbVie,,4.0,,,f,,,,t,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,INDUSTRY,,,,,,,2022,1.0
NCT04820023,,2021-03-23,,,2023-12-12,2021-03-25,2021-03-29,ACTUAL,,,,,,,2023-12-12,2023-12-14,ACTUAL,2021-04-02,ACTUAL,2021-04-02,2023-12,2023-12-31,2023-11-29,ACTUAL,2023-11-29,2023-11-29,ACTUAL,2023-11-29,,INTERVENTIONAL,,,Phase 1/2 Study of BBT-176 in Advanced NSCLC With Progression After EGFR TKI Treatment,"A Phase 1/2, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of BBT-176 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Progressed Following Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) Agent",TERMINATED,,PHASE1/PHASE2,45.0,ACTUAL,"Bridge Biotherapeutics, Inc.",,1.0,,Sponsor's decision considering the changing treatment landscape for NSCLC,f,,,,,t,f,,,f,,,,,,,,2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,INDUSTRY,,,,,,,2023,0.0
NCT05205837,,2021-12-10,,,2024-02-14,2022-01-12,2022-01-25,ACTUAL,,,,,,,2024-02-14,2024-02-15,ACTUAL,2021-11-24,ACTUAL,2021-11-24,2024-02,2024-02-29,2023-08-15,ACTUAL,2023-08-15,2023-08-15,ACTUAL,2023-08-15,,INTERVENTIONAL,,,"A Randomized, Double-blinded, Clinical, Placebo-controlled Trial on the Effects of Therapy With Letrozole and hUman Choriongonadotropin in Male Hypogonadism Induced by Illicit Use of Anabolic Androgenic Steroids- The LUCAS Trial","A Randomized, Double-blinded, Clinical, Placebo-controlled Trial on the Effects of Therapy With Letrozole and hUman Choriongonadotropin in Male Hypogonadism Induced by Illicit Use of Anabolic Androgenic Steroids on Plasma Reproductive Hormones, Fertility, Withdrawal Symptoms and Myocardial Function - The LUCAS Trial",TERMINATED,,PHASE4,8.0,ACTUAL,"Rigshospitalet, Denmark",,2.0,,Lack of recruitment,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,OTHER,,,,,,,2023,0.0
NCT04132349,,2019-10-15,,,2020-04-09,2019-10-16,2019-10-18,ACTUAL,,,,,,,2020-04-09,2020-04-13,ACTUAL,2019-10-23,ACTUAL,2019-10-23,2020-04,2020-04-30,2020-04-01,ACTUAL,2020-04-01,2020-04-01,ACTUAL,2020-04-01,,INTERVENTIONAL,,,Ulipristal Acetate in Symptomatic Uterine Fibroid,The Effectiveness and Safety of Ulipristal Acetate in Women With Symptomatic Uterine Fibroid,TERMINATED,,PHASE4,25.0,ACTUAL,Mỹ Đức Hospital,,1.0,,Ulipristal Acetate was recalled,f,,,,f,f,f,,,,,,,,,,,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,OTHER,,,,,,,2020,0.0
NCT02994784,,2016-11-18,2023-04-21,,2023-05-22,2016-12-13,2016-12-16,ESTIMATED,2023-05-22,2023-05-24,ACTUAL,,,,2023-05-22,2023-05-24,ACTUAL,2018-01-08,ACTUAL,2018-01-08,2023-05,2023-05-31,2022-07-01,ACTUAL,2022-07-01,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,,,Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients,"A Phase II Single-Center, Open-Label, Safety and Efficacy Study of Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients Undergoing Autologous Stem Cell Transplantation",TERMINATED,,PHASE2,27.0,ACTUAL,Boston Medical Center,Study was halted early resulting in relatively small numbers of participants analyzed.,1.0,,"Slow Accrual during COVID pandemic, alternative treatments available. Study halted early.",f,,,,f,t,f,,,f,,,,,,NO,There are no plans to share individual participant data.,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,OTHER,,,,,,,2022,0.0
NCT03588611,,2018-07-03,,,2021-08-06,2018-07-13,2018-07-17,ACTUAL,,,,,,,2021-08-06,2021-08-09,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2021-08,2021-08-31,2021-06-26,ACTUAL,2021-06-26,2021-06-26,ACTUAL,2021-06-26,,INTERVENTIONAL,,,Reduce Bolus Injection of Bivalirudin,The Noninferiority and Safety of Bivalirudin Between REDUCEd and Standard BOLUSin Percutaneous Coronary Intervention Patients Stratified by Renal Function,COMPLETED,,PHASE4,204.0,ACTUAL,Shenyang Northern Hospital,,4.0,,,f,,,,,f,f,,,f,,,,,,,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,OTHER,,,,,,,2021,1.0
NCT02910583,,2016-09-20,2021-11-09,,2024-04-01,2016-09-20,2016-09-22,ESTIMATED,2022-01-27,2022-02-18,ACTUAL,,,,2024-04-01,2024-04-03,ACTUAL,2016-09-28,ACTUAL,2016-09-28,2024-03,2024-03-31,2024-03-27,ACTUAL,2024-03-27,2020-11-12,ACTUAL,2020-11-12,,INTERVENTIONAL,Captivate,,Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL),Phase 2 Study of the Combination of Ibrutinib Plus Venetoclax in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma,COMPLETED,,PHASE2,323.0,ACTUAL,Pharmacyclics LLC.,,5.0,,,f,,,,f,t,f,,,f,,,,,http://yoda.yale.edu,YES,"Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.",2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,INDUSTRY,,,,,,,2024,1.0
NCT04358406,,2020-04-16,2022-05-04,,2023-11-04,2020-04-21,2020-04-24,ACTUAL,2023-01-25,2023-02-09,ACTUAL,,,,2023-11-04,2023-11-28,ACTUAL,2020-07-30,ACTUAL,2020-07-30,2023-09,2023-09-30,2022-01-28,ACTUAL,2022-01-28,2021-05-25,ACTUAL,2021-05-25,,INTERVENTIONAL,,,Rhu-pGSN for Severe Covid-19 Pneumonia,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Proof-Of-Concept Study To Evaluate Efficacy And Safety Of Recombinant Human Plasma Gelsolin (Rhu-pGSN) Added To Standard Of Care In Subjects With Severe Covid-19 Pneumonia",COMPLETED,,PHASE2,64.0,ACTUAL,BioAegis Therapeutics Inc.,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,INDUSTRY,,,,,,,2022,1.0
NCT04468230,,2020-07-07,2023-09-01,2023-07-13,2023-10-17,2020-07-07,2020-07-13,ACTUAL,2023-10-17,2023-11-08,ACTUAL,,2023-11-08,ACTUAL,2023-10-17,2023-11-08,ACTUAL,2020-07-31,ACTUAL,2020-07-31,2023-10,2023-10-31,2022-05-31,ACTUAL,2022-05-31,2022-05-31,ACTUAL,2022-05-31,,INTERVENTIONAL,,Confidentiality is an issue.,Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy,Phase 2 Study of Nicotine for the Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy,TERMINATED,,PHASE2,4.0,ACTUAL,Virginia Commonwealth University,The Coronavirus-19 (COVID-19) pandemic caused reduced accrual rates. The protocol was terminated early due to slow accrual rates by the Protocol Review \& Monitoring Committee (PRMC).,1.0,,Low Accrual Rate,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,OTHER,,,,,,,2022,0.0
NCT03979820,,2019-06-06,2021-05-11,,2021-05-11,2019-06-06,2019-06-07,ACTUAL,2021-05-11,2021-06-04,ACTUAL,,,,2021-05-11,2021-06-04,ACTUAL,2019-07-31,ACTUAL,2019-07-31,2021-03,2021-03-31,2020-04-08,ACTUAL,2020-04-08,2020-04-08,ACTUAL,2020-04-08,,INTERVENTIONAL,,Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. The TS was used for the analysis of safety.,A Study in Healthy People to Test How Combining BI 1467335 and Tyramine Affects Blood Pressure,"A Phase I Parallel Group Study in Healthy Subjects to Evaluate the Effect of Multiple Oral Doses of BI 1467335 and Phenelzine as Positive Control on Blood Pressure Response to Oral Tyramine (Double-blind, Randomised, Placebo-controlled Design for BI 1467335 Treatment Groups, Open Label for Phenelzine)",TERMINATED,,PHASE1,53.0,ACTUAL,Boehringer Ingelheim,The sponsor decided to permanently discontinue the trial on 14 April 2020 due to lock down of the trial site enforced by the Covid-19 pandemic. Therefore some of the planned analysis were not performed due to lack of data.,4.0,,Study discontinued - testing of highest dose obsolete,f,,,,f,f,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/",2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,INDUSTRY,,,,,,,2020,0.0
NCT05611853,,2022-10-26,,,2024-02-20,2022-11-09,2022-11-10,ACTUAL,,,,,,,2024-02-20,2024-02-21,ACTUAL,2022-11-25,ACTUAL,2022-11-25,2024-02,2024-02-29,2023-12-25,ACTUAL,2023-12-25,2023-12-25,ACTUAL,2023-12-25,,INTERVENTIONAL,,,"Study of BN301, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies","A Multicenter Phase 1/2 Clinical Study to Evaluate the Safety and Efficacy of BN301，An Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-cell Non-Hodgkin's Lymphoma",TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,BioNova Pharmaceuticals (Shanghai) LTD.,,3.0,,Due to company decision,f,,,,f,f,f,,,,,,,,,,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,INDUSTRY,,,,,,,2023,0.0
NCT04692467,,2020-12-15,2024-03-11,,2024-03-11,2020-12-29,2020-12-31,ACTUAL,2024-03-11,2024-04-09,ACTUAL,,,,2024-03-11,2024-04-09,ACTUAL,2021-02-26,ACTUAL,2021-02-26,2024-03,2024-03-31,2023-12-30,ACTUAL,2023-12-30,2023-06-30,ACTUAL,2023-06-30,,INTERVENTIONAL,,"In intention-to-treat analysis, the analysis population is the same as the assignment under randomization.",Treatment of Early Hypertension Among Persons Living With HIV in Haiti,Treatment of Early Hypertension Among Persons Living With HIV in Haiti,COMPLETED,,PHASE2,250.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,,f,,,,t,f,f,,,f,,,Study protocol and statistical analysis plan available after publication and ending 3 years following publication.,"Researchers who provide a methodologically sound proposal may have access. Proposals should be directed to the PI at mam9365@med.cornell.edu. To gain access, data requestors will need to sign a data access agreement. Data are available following publications through 3 years after publication and will be provided directly from the PI.",,YES,"All the individual participant data collected during the trial, after deidentification will be shared.",2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,OTHER,,,,,,,2023,1.0
NCT04700280,,2021-01-06,2022-11-08,,2022-11-08,2021-01-06,2021-01-07,ACTUAL,2022-11-08,2023-09-18,ACTUAL,,,,2022-11-08,2023-09-18,ACTUAL,2021-01-28,ACTUAL,2021-01-28,2022-11,2022-11-30,2021-12-27,ACTUAL,2021-12-27,2021-10-28,ACTUAL,2021-10-28,,INTERVENTIONAL,GLIDER,The safety analysis set included all randomized participants who received at least one dose of study drug.,A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 12 Weeks in Adults With Active Primary Sjögren's Syndrome (pSS),"A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Primary Sjögren's Syndrome",TERMINATED,,PHASE2,31.0,ACTUAL,Galapagos NV,"There were limitations in the dataset, given the small number of participants completing the treatment period due to early termination of the study.",2.0,,Study was terminated based on Sponsor decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,INDUSTRY,,,,,,,2021,0.0
NCT02661464,,2016-01-08,2023-12-14,2022-12-07,2023-12-14,2016-01-19,2016-01-22,ESTIMATED,2023-12-14,2024-01-02,ACTUAL,2022-12-07,2022-12-12,ACTUAL,2023-12-14,2024-01-02,ACTUAL,2016-05-31,ACTUAL,2016-05-31,2023-12,2023-12-31,2021-12-13,ACTUAL,2021-12-13,2021-12-13,ACTUAL,2021-12-13,,INTERVENTIONAL,,"Full analysis set (FAS) included all participants who were enrolled in this study and had at least one post-baseline visit, regardless of the occurrence of protocol deviations.",Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo,"A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo",TERMINATED,,PHASE3,677.0,ACTUAL,Janssen Vaccines & Prevention B.V.,"As none of the participants met Cohort 2 eligibility criteria pre-specified in the protocol, therefore no participants were enrolled in Cohort 2. So the results were only presented for Cohorts 1 and 3.",1.0,,"Due to the pandemic with only one participant in follow up, as the impact on the safety was determined to be negligible, the study was terminated early.",f,,,,f,t,f,,,,,,,,,,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,INDUSTRY,,,,,,,2021,0.0
NCT03732638,,2018-11-05,2021-05-28,2020-11-24,2024-05-23,2018-11-05,2018-11-06,ACTUAL,2021-08-05,2021-08-09,ACTUAL,2021-08-05,2021-08-09,ACTUAL,2024-05-23,2024-06-07,ACTUAL,2018-11-14,ACTUAL,2018-11-14,2022-12,2022-12-31,2021-02-02,ACTUAL,2021-02-02,2019-12-10,ACTUAL,2019-12-10,,INTERVENTIONAL,,Participants who received at least one dose of study drug.,Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults,"A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention",COMPLETED,,PHASE2/PHASE3,1590.0,ACTUAL,Pfizer,,2.0,,,,,,,,t,f,,,,,,,,,,,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,INDUSTRY,,,,,,,2021,1.0
NCT02382523,,2015-01-09,,,2017-04-03,2015-03-05,2015-03-06,ESTIMATED,,,,,,,2017-04-03,2017-04-05,ACTUAL,2015-02,,2015-02-28,2017-04,2017-04-30,2020-01,ESTIMATED,2020-01-31,2019-01,ESTIMATED,2019-01-31,,INTERVENTIONAL,,,Acthar on Proteinuria in IgA Nephropathy Patients,Impact of Acthar on Proteinuria and Disease Progression in IgA Nephropathy Patients With Nephrotic Range Proteinuria,WITHDRAWN,,PHASE4,0.0,ACTUAL,Baylor College of Medicine,,2.0,,There were no subjects enrolled locally on this study since it opened. Local IRB closure has been requested.,f,,,,t,,,,,,,,,,,,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,OTHER,,,,,,,2020,0.0
NCT05093608,,2021-10-15,,,2022-10-13,2021-10-15,2021-10-26,ACTUAL,,,,,,,2022-10-13,2022-10-17,ACTUAL,2021-11-03,ACTUAL,2021-11-03,2022-10,2022-10-31,2022-10-12,ACTUAL,2022-10-12,2022-10-12,ACTUAL,2022-10-12,,INTERVENTIONAL,,,SELINEXOR in Combination w/Bevacizumab and Atezolizumab in Newly Diagnosed Advanced Hepatocellular Carcinoma,An Investigator-initiated Phase I Study of SELINEXOR in Combination With Bevacizumab and Atezolizumab in Newly Diagnosed Advanced Hepatocellular Carcinoma,TERMINATED,,PHASE1,2.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,2.0,,Loss of funding,f,,,,t,t,f,,,t,,,,,,,,2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,OTHER,,,,,,,2022,0.0
NCT03993457,,2019-06-13,2023-03-23,,2023-03-23,2019-06-19,2019-06-20,ACTUAL,2023-03-23,2023-04-18,ACTUAL,,,,2023-03-23,2023-04-18,ACTUAL,2019-07-23,ACTUAL,2019-07-23,2023-03,2023-03-31,2022-03-25,ACTUAL,2022-03-25,2022-03-25,ACTUAL,2022-03-25,,INTERVENTIONAL,PRECISE-D,,Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression,Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression,TERMINATED,,PHASE4,18.0,ACTUAL,University of Texas Southwestern Medical Center,,4.0,,terminated during COVID due to inability to see participants in person.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,OTHER,,,,,,,2022,0.0
NCT04114097,,2019-10-01,,,2021-04-27,2019-10-02,2019-10-03,ACTUAL,,,,,,,2021-04-27,2021-04-28,ACTUAL,2019-08-22,ACTUAL,2019-08-22,2021-04,2021-04-30,2021-03-15,ACTUAL,2021-03-15,2021-03-15,ACTUAL,2021-03-15,,INTERVENTIONAL,,,The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover,The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover,COMPLETED,,PHASE4,36.0,ACTUAL,"University Hospital, Gentofte, Copenhagen",,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,OTHER,,,,,,,2021,1.0
NCT03819218,,2019-01-11,2021-02-01,,2021-02-23,2019-01-25,2019-01-28,ACTUAL,2021-02-01,2021-02-21,ACTUAL,,,,2021-02-23,2021-03-19,ACTUAL,2018-12-27,ACTUAL,2018-12-27,2021-02,2021-02-28,2020-12-11,ACTUAL,2020-12-11,2020-12-11,ACTUAL,2020-12-11,,INTERVENTIONAL,,,A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream in Adolescent Subjects,"A Multicentre, Open-label, Single-group Maximal Use Trial, Evaluating the Safety and Pharmacokinetic Profile of the Active Ingredients and Their Metabolites After Application of MC2-01 Cream in Adolescents With Extensive Psoriasis Vulgaris",TERMINATED,,PHASE2,7.0,ACTUAL,MC2 Therapeutics,,1.0,,Lack of recruitment,f,,,,f,t,f,,,,,,,,,,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,INDUSTRY,,,,,,,2020,0.0
NCT03118570,,2017-04-03,2021-12-13,,2023-06-29,2017-04-13,2017-04-18,ACTUAL,2022-02-07,2022-03-02,ACTUAL,,,,2023-06-29,2023-07-05,ACTUAL,2017-09-11,ACTUAL,2017-09-11,2022-02,2022-02-28,2020-11-12,ACTUAL,2020-11-12,2019-10-01,ACTUAL,2019-10-01,,INTERVENTIONAL,Asteroid,The 19 participants who transitioned from the Placebo arm to the Setrusumab 20 mg/kg Open-Label arm are NOT double-counted for this analysis.,"A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804","A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, Incorporating an Open Label Substudy, in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With Setrusumab (BPS804)",COMPLETED,,PHASE2,112.0,ACTUAL,Ultragenyx Pharmaceutical Inc,,5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,INDUSTRY,,,,,,,2020,1.0
NCT04232813,,2020-01-10,,,2021-02-10,2020-01-14,2020-01-18,ACTUAL,,,,,,,2021-02-10,2021-02-11,ACTUAL,2020-01-09,ACTUAL,2020-01-09,2021-02,2021-02-28,2020-11-30,ACTUAL,2020-11-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream,Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream,COMPLETED,,PHASE3,120.0,ACTUAL,Instituto Palacios,,2.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,OTHER,,,,,,,2020,1.0
NCT03330834,,2017-10-01,2020-04-15,,2020-07-09,2017-10-30,2017-11-06,ACTUAL,2020-07-09,2020-07-13,ACTUAL,,,,2020-07-09,2020-07-13,ACTUAL,2017-11-20,ACTUAL,2017-11-20,2020-07,2020-07-31,2020-04-14,ACTUAL,2020-04-14,2020-04-14,ACTUAL,2020-04-14,,INTERVENTIONAL,,,CAR-T Cell Immunotherapy for Advanced Lung Cancer,Safety and Toxicity of CAR-T Cell Immunotherapy in Patients With Advanced Lung Cancer After Standard Treatment Failure: A Single-Arm and Single-Center Phase I Clinical Study,TERMINATED,,PHASE1,1.0,ACTUAL,Sun Yat-sen University,,1.0,,Serious adverse events,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,OTHER,,,,,,,2020,0.0
NCT03353454,,2017-11-14,,,2019-03-14,2017-11-22,2017-11-27,ACTUAL,,,,,,,2019-03-14,2019-03-18,ACTUAL,2018-10-25,ESTIMATED,2018-10-25,2019-03,2019-03-31,2020-06-15,ESTIMATED,2020-06-15,2020-06-15,ESTIMATED,2020-06-15,,INTERVENTIONAL,,,A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC),Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat (SHP625) in the Treatment of Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC),WITHDRAWN,,PHASE3,0.0,ACTUAL,"Mirum Pharmaceuticals, Inc.",,2.0,,The study was withdrawn due to change of ownership of the study drug maralixibat. Future studies of maralixibat will be posted by Mirum Pharmaceuticals.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,INDUSTRY,,,,,,,2020,0.0
NCT04201145,,2019-12-13,,,2020-11-16,2019-12-13,2019-12-17,ACTUAL,,,,,,,2020-11-16,2020-11-17,ACTUAL,2020-09,ESTIMATED,2020-09-30,2020-11,2020-11-30,2022-12-31,ESTIMATED,2022-12-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Pembrolizumab + Defactinib In Pleural Mesothelioma,"Phase IA-IB Open-label, Non-randomized, Neoadjuvant Treatment With Combination Pembrolizumab and Defactinib for Patients With Surgically Resectable Malignant Pleural Mesothelioma",WITHDRAWN,,PHASE1,0.0,ACTUAL,Dana-Farber Cancer Institute,,4.0,,Funding complications coupled with competing scientific objectives,f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,Contact the Partners Innovations team at http://www.partners.org/innovation,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,OTHER,,,,,,,2022,0.0
NCT01771471,,2013-01-14,,,2017-08-29,2013-01-16,2013-01-18,ESTIMATED,,,,,,,2017-08-29,2017-08-31,ACTUAL,2012-11,,2012-11-30,2016-09,2016-09-30,2020-09,ESTIMATED,2020-09-30,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo,"A Phase II, Randomized, Double Blind, Placebo Controlled Study Evaluating the Treatment of Degenerative Lumbar Discs With Allogeneic Cultured Chondrocytes",TERMINATED,,PHASE2,44.0,ACTUAL,"ISTO Technologies, Inc.",,2.0,,Change in clinical strategy,f,,,,t,,,,,,,,,,,,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,INDUSTRY,,,,,,,2020,0.0
NCT04320290,,2020-03-23,,,2022-08-29,2020-03-23,2020-03-24,ACTUAL,,,,,,,2022-08-29,2022-08-31,ACTUAL,2020-05-21,ACTUAL,2020-05-21,2022-08,2022-08-31,2020-06-16,ACTUAL,2020-06-16,2020-06-16,ACTUAL,2020-06-16,,INTERVENTIONAL,,,HCV + to HCV - Kidney Transplant,Hepatitis C Viral Kidneys Used for Non-Viremic Recipients,WITHDRAWN,,PHASE4,0.0,ACTUAL,Massachusetts General Hospital,,1.0,,New Related Protocol to be submitted,f,,,,f,t,f,,,f,,,Ancicipate data would be available to share by 6 months are the final patient visit.,Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.,,YES,Anticipate to share coded data with collaborators,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,OTHER,,,,,,,2020,0.0
NCT04136145,,2019-10-21,2020-11-30,,2020-11-30,2019-10-21,2019-10-23,ACTUAL,2020-11-30,2020-12-28,ACTUAL,,,,2020-11-30,2020-12-28,ACTUAL,2019-10-28,ACTUAL,2019-10-28,2020-11,2020-11-30,2020-01-14,ACTUAL,2020-01-14,2020-01-14,ACTUAL,2020-01-14,,INTERVENTIONAL,,,Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Subjects,"An Open-label, Randomized, Parallel Group, Single Dose Study to Investigate the PK and Safety of Belimumab 200 mg Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Participants",COMPLETED,,PHASE1,36.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,f,f,f,,,,,,IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,INDUSTRY,,,,,,,2020,1.0
NCT04695704,,2021-01-04,,,2024-07-01,2021-01-04,2021-01-05,ACTUAL,,,,,,,2024-07-01,2024-07-03,ACTUAL,2021-08-11,ACTUAL,2021-08-11,2024-07,2024-07-31,2023-08-28,ACTUAL,2023-08-28,2023-07-24,ACTUAL,2023-07-24,,INTERVENTIONAL,E-SPERANZA,,Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19:,"Double-blind Randomized Clinical Trial, Placebo-controlled to Assess the Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19: E-SPERANZA COVID-19 PROJECT",TERMINATED,,PHASE3,86.0,ACTUAL,Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina,,2.0,,"The incidence of respiratory Long COVID has decreased in the new waves, thus made impossible to achieve the required study sample.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,OTHER,,,,,,,2023,0.0
NCT04639843,,2020-11-20,,,2022-11-03,2020-11-20,2020-11-23,ACTUAL,,,,,,,2022-11-03,2022-11-04,ACTUAL,2022-11-03,ACTUAL,2022-11-03,2022-11,2022-11-30,2022-11-03,ACTUAL,2022-11-03,2022-11-03,ACTUAL,2022-11-03,,INTERVENTIONAL,,,"Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma","A Phase 1 Study of Doxorubicin, CC-486 (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma",WITHDRAWN,,PHASE1,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,Safety issues with PI3 kinase inhibitors,f,,,,,t,f,,,,,,Clinical data will be available during the study and indefinitely.,Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.,,YES,.All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@All collected IPD will be shared with collaborators under the terms of collaborative agreements.,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,NIH,,,,,,,2022,0.0
NCT03130439,,2017-04-24,2022-08-26,,2024-04-26,2017-04-24,2017-04-26,ACTUAL,2022-08-26,2022-09-22,ACTUAL,,,,2024-04-26,2024-04-30,ACTUAL,2017-05-26,ACTUAL,2017-05-26,2024-04,2024-04-30,2022-01-30,ACTUAL,2022-01-30,2021-08-18,ACTUAL,2021-08-18,,INTERVENTIONAL,,,"Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer","A Phase 2 Study of Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer",TERMINATED,,PHASE2,27.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,Slow accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,OTHER,,,,,,,2022,0.0
NCT03820726,,2019-01-28,2023-08-18,,2023-08-18,2019-01-28,2019-01-29,ACTUAL,2023-08-18,2023-09-13,ACTUAL,,,,2023-08-18,2023-09-13,ACTUAL,2019-04-16,ACTUAL,2019-04-16,2023-08,2023-08-31,2022-08-30,ACTUAL,2022-08-30,2022-08-30,ACTUAL,2022-08-30,,INTERVENTIONAL,,Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).,A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD),An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD),COMPLETED,,PHASE3,435.0,ACTUAL,Boehringer Ingelheim,,1.0,,,f,,,,f,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"Once the criteria in section 'time frame frame' are fulfilled , researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.",2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,INDUSTRY,,,,,,,2022,1.0
NCT03852160,,2019-02-12,,,2019-11-22,2019-02-21,2019-02-25,ACTUAL,,,,,,,2019-11-22,2019-11-26,ACTUAL,2019-12-01,ESTIMATED,2019-12-01,2019-11,2019-11-30,2021-07-25,ESTIMATED,2021-07-25,2021-07-25,ESTIMATED,2021-07-25,,INTERVENTIONAL,,,A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression,"A Randomized, Double-Blind, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly-dosed Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression",WITHDRAWN,,PHASE3,0.0,ACTUAL,Janssen-Cilag International NV,,2.0,,"New design was developed to better fit company strategy, a new study has replaced 5413541TRD3011 study",f,,,,f,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 08:58:51.314314,2024-10-16 08:58:51.314314,INDUSTRY,,,,,,,2021,0.0
NCT05042934,,2021-09-07,,,2022-02-01,2021-09-08,2021-09-13,ACTUAL,,,,,,,2022-02-01,2022-02-10,ACTUAL,2021-09-15,ESTIMATED,2021-09-15,2022-02,2022-02-28,2022-08-30,ESTIMATED,2022-08-30,2022-08-30,ESTIMATED,2022-08-30,,INTERVENTIONAL,,,Lurbinectedin With or Without Irinotecan in Treating Patients With Relapsed or High Risk Metastatic Ewing Sarcoma,Phase 1B/2 Study of Lurbinectedin With or Without Irinotecan for Patients With Relapsed or High Risk Chemotherapy-Naive Ewing Sarcoma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,"PI stated trial no longer fits the framework \& portfolio of work that is prioritized by the department. PI will not have the anticipated accrual in PI view to complete the study. Given that, PI request this protocol be closed prior to its activation.",f,,,,f,t,f,,,,,,,,,,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,OTHER,,,,,,,2022,0.0
NCT00943722,,2009-07-21,2014-12-12,,2022-09-22,2009-07-21,2009-07-22,ESTIMATED,2015-01-12,2015-01-13,ESTIMATED,,,,2022-09-22,2022-10-03,ACTUAL,2009-08-27,ACTUAL,2009-08-27,2022-09,2022-09-30,2021-04-22,ACTUAL,2021-04-22,2011-04-30,ACTUAL,2011-04-30,,INTERVENTIONAL,,"Per protocol, baseline characteristics were analyzed in all participants randomized in the base study.",A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002),"A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)",COMPLETED,,PHASE3,3074.0,ACTUAL,Merck Sharp & Dohme LLC,,5.0,,,f,,,,t,,,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,INDUSTRY,,,,,,,2021,1.0
NCT04255862,,2020-02-03,,,2021-08-12,2020-02-03,2020-02-05,ACTUAL,,,,,,,2021-08-12,2021-08-17,ACTUAL,2020-02-12,ACTUAL,2020-02-12,2021-08,2021-08-31,2021-04-26,ACTUAL,2021-04-26,2021-04-26,ACTUAL,2021-04-26,,INTERVENTIONAL,,,A Study to Evaluate the Bioequivalence of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants,"An Open-Label, Single-Center, Randomized, Parallel-Group, Single-Dose Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants",TERMINATED,,PHASE1,71.0,ACTUAL,UCB Pharma,,4.0,,Study recruitment terminated due to operational difficulties executing the study under the COVID-19 pandemic.,f,,,,f,f,f,,,,,,,,,NO,Data from Phase 1 trials in Healthy Volunteers is outside of UCB's data sharing policy and is unavailable for sharing.,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,INDUSTRY,,,,,,,2021,0.0
NCT04466410,,2020-06-24,,,2023-01-19,2020-07-09,2020-07-10,ACTUAL,,,,,,,2023-01-19,2023-01-23,ACTUAL,2021-04-14,ACTUAL,2021-04-14,2023-01,2023-01-31,2022-09-27,ACTUAL,2022-09-27,2022-09-27,ACTUAL,2022-09-27,,INTERVENTIONAL,,,Safety and Efficacy of XT-150 for Treatment of Neuropathic Pain,"A Double Blind, Placebo Controlled, Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Neuropathic Pain",TERMINATED,,PHASE1,5.0,ACTUAL,"Xalud Therapeutics, Inc.",,4.0,,Failure to enroll a sufficient number of patients.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,INDUSTRY,,,,,,,2022,0.0
NCT03394924,,2017-12-23,2021-03-05,2020-12-08,2021-04-27,2018-01-03,2018-01-09,ACTUAL,2021-04-27,2021-05-18,ACTUAL,2021-04-27,2021-05-18,ACTUAL,2021-04-27,2021-05-18,ACTUAL,2017-12-27,ACTUAL,2017-12-27,2020-06,2020-06-30,2020-01-16,ACTUAL,2020-01-16,2019-12-19,ACTUAL,2019-12-19,,INTERVENTIONAL,,,"A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis","A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)",COMPLETED,,PHASE2,68.0,ACTUAL,"Enanta Pharmaceuticals, Inc",,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,INDUSTRY,,,,,,,2020,1.0
NCT04546802,,2018-10-14,,,2020-09-06,2020-09-06,2020-09-14,ACTUAL,,,,,,,2020-09-06,2020-09-14,ACTUAL,2019-09,ESTIMATED,2019-09-30,2020-09,2020-09-30,2023-06,ESTIMATED,2023-06-30,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,HATCHeT,,HepATocellular Cancer Hcv Therapy Study,"Open Label Trial to Study the Efficacy and Safety of MK-5172 and MK-8742 +/- Ribavirin (RBV) in the Treatment of Hepatitis C G1 and 4, in Patients Eligible for Liver Transplant (HCC) or Curative Therapy or Clinically Stable Disease Post Local Resection, Embolization or Ablative Therapy",WITHDRAWN,,PHASE3,0.0,ACTUAL,Bayside Health,,2.0,,Recruitment will be too difficult due to available PBS funded treatment and recent Australian clinical guidelines will conflict with the premise of the study.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,OTHER_GOV,,,,,,,2023,0.0
NCT05552859,,2022-09-07,2024-05-30,,2024-08-30,2022-09-20,2022-09-23,ACTUAL,2024-08-30,2024-09-05,ACTUAL,,,,2024-08-30,2024-09-05,ACTUAL,2022-12-05,ACTUAL,2022-12-05,2024-08,2024-08-31,2023-08-04,ACTUAL,2023-08-04,2023-07-28,ACTUAL,2023-07-28,,INTERVENTIONAL,TRENT,,Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment,"A 24-Week, Multicenter, Randomized, Open-Label, Parallel-Group Trial Comparing the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) and Insulin Degludec 100 U/mL (IDeg-100) in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment: TRENT Trial",TERMINATED,,PHASE4,62.0,ACTUAL,Sanofi,"The sponsor made the strategic decision to discontinue the trial due to a significant recruitment delay (ie, the number of randomized participants remained significantly lower \[\<10% than originally planned sample size\]). No safety signals were detected during the trial, and the trial team remained blinded to the data collected for the randomized participants at the time of early discontinuation of the trial.",2.0,,Sponsor decision to cancel trial due to poor recruitment/ severe recruitment delay and not related to safety concern.,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,INDUSTRY,,,,,,,2023,0.0
NCT04021082,,2019-07-08,,,2023-02-17,2019-07-12,2019-07-16,ACTUAL,,,,,,,2023-02-17,2023-02-21,ACTUAL,2019-11-15,ESTIMATED,2019-11-15,2020-03,2020-03-31,2023-06-01,ESTIMATED,2023-06-01,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,CELTIC-1: A Phase 2B Study of Cerdulatinib in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL),"CELTIC-1 (Clinical Evaluation of T-cell NHL With Cerdulatinib): A Phase 2b, Open Label, Multidose, Multinational Study of Cerdulatinib (PRT062070) in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL)",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,4.0,,Sponsor decision to not initiate the trial,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,INDUSTRY,,,,,,,2023,0.0
NCT04394143,,2020-05-11,,,2021-08-05,2020-05-18,2020-05-19,ACTUAL,,,,,,,2021-08-05,2021-08-06,ACTUAL,2020-10-20,ACTUAL,2020-10-20,2021-08,2021-08-31,2021-07-19,ACTUAL,2021-07-19,2021-07-19,ACTUAL,2021-07-19,,INTERVENTIONAL,,,Effect of AD128 to Treat Obstructive Sleep Apnea,"Effect of AD128 on Obstructive Sleep Apnea Severity: a Randomized, Placebo-controlled, Double-blind, Cross-over Study",COMPLETED,,PHASE2/PHASE3,15.0,ACTUAL,Centre Hospitalier Universitaire Vaudois,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,Individual participant data (IPD) could be transmitted on request after publication to researchers who provide a methodologically sound proposal.,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,OTHER,,,,,,,2021,0.0
NCT03773744,,2018-12-10,,,2021-04-01,2018-12-11,2018-12-12,ACTUAL,,,,,,,2021-04-01,2021-04-06,ACTUAL,2020-02-15,ACTUAL,2020-02-15,2021-04,2021-04-30,2021-12-31,ESTIMATED,2021-12-31,2020-10-30,ESTIMATED,2020-10-30,,INTERVENTIONAL,Pelican,,MG1-MAGEA3 With Ad-MAGEA3 and Pembrolizumab in Patients With Previously Treated Metastatic Melanoma or Cutaneous Squamous Cell Carcinoma,"A Phase 1b, Multicenter, Open-label Trial of Oncolytic MG1 Expressing MAGE-A3 (MG1-MAGEA3) With Adenovirus Vaccine Expressing MAGE-A3 (Ad-MAGEA3), in Combination With Immune Modulating Therapy in Patients With Metastatic Melanoma or Previously Treated Cutaneous Squamous Cell Carcinoma",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Turnstone Biologics, Corp.",,2.0,,insufficient suitable drug supply,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,INDUSTRY,,,,,,,2021,0.0
NCT04398368,,2020-05-16,2023-07-17,,2023-07-17,2020-05-20,2020-05-21,ACTUAL,2023-07-17,2023-08-08,ACTUAL,,,,2023-07-17,2023-08-08,ACTUAL,2020-06-05,ACTUAL,2020-06-05,2023-07,2023-07-31,2023-02-02,ACTUAL,2023-02-02,2023-02-02,ACTUAL,2023-02-02,,INTERVENTIONAL,,,"Gemcitabine for the Prevention of Intravesical Recurrence of Urothelial Cancer in Patients With Upper Urinary Tract Urothelial Cancer Undergoing Radical Nephroureterectomy, GEMINI Study","GEMINI: An Open-Label, Single-Arm, Phase II Study of Intraoperative Gemcitabine Intravesical Instillation in Patients Undergoing Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma",TERMINATED,,PHASE2,25.0,ACTUAL,Mayo Clinic,Study target enrollment was anticipated for 90 participants but only 23 participants completed treatment before study was terminated. The study was terminated due to insufficient resources and funding to support continuation of the trial. PI decision to terminate.,1.0,,Focus research efforts on other projects.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,OTHER,,,,,,,2023,0.0
NCT02437318,,2015-04-22,2019-06-17,2018-07-24,2023-11-17,2015-05-04,2015-05-07,ESTIMATED,2019-07-22,2019-08-13,ACTUAL,2018-07-24,2018-07-26,ACTUAL,2023-11-17,2023-11-18,ACTUAL,2015-07-23,ACTUAL,2015-07-23,2023-11,2023-11-30,2023-06-09,ACTUAL,2023-06-09,2018-06-12,ACTUAL,2018-06-12,,INTERVENTIONAL,SOLAR-1,The Full analysis set (FAS) comprised of all subjects who were randomized to study treatment (alpelisib plus fulvestrant or matching placebo plus fulvestrant).,Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.,"A Phase III Randomized Double-blind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment",COMPLETED,,PHASE3,572.0,ACTUAL,Novartis,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,INDUSTRY,,,,,,,2023,1.0
NCT04157036,,2019-11-06,,,2022-08-26,2019-11-06,2019-11-08,ACTUAL,,,,,,,2022-08-26,2022-08-29,ACTUAL,2020-02-01,ACTUAL,2020-02-01,2020-02,2020-02-29,2021-10-06,ACTUAL,2021-10-06,2021-09-01,ACTUAL,2021-09-01,,INTERVENTIONAL,,,Evaluation of Methylprednisolone or Ibuprofen on Efficacy of Nerve Blocks With Symptomatic Irreversible Pulpitis,Comparative Evaluation of Preoperative Methylprednisolone or Ibuprofen on Anesthetic Efficacy of Inferior Alveolar Nerve Blocks in Patients With Symptomatic Irreversible Pulpitis,TERMINATED,,PHASE3,3.0,ACTUAL,Walter Reed National Military Medical Center,,2.0,,"COVID halted recruitment for 2 years. A majority of patients eligible for the study had already taken preoperative analgesics, which disqualified them for the study.",f,,,,f,t,f,,,t,,,,,,NO,There is not a plan to share our data with any other Researchers.,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,FED,,,,,,,2021,0.0
NCT03713320,,2018-10-17,2021-08-03,,2022-03-15,2018-10-17,2018-10-19,ACTUAL,2022-03-15,2022-04-08,ACTUAL,,,,2022-03-15,2022-04-08,ACTUAL,2019-04-02,ACTUAL,2019-04-02,2022-03,2022-03-31,2020-12-01,ACTUAL,2020-12-01,2020-10-12,ACTUAL,2020-10-12,,INTERVENTIONAL,SOLAR,,SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides,"SOLAR: A Phase 2, Randomized, Open-label, Parallel-group, Active Comparator, Multi-center Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype",TERMINATED,,PHASE2,37.0,ACTUAL,"miRagen Therapeutics, Inc.","The study was terminated early for business reasons, and not due to concerns regarding safety or lack of efficacy. Because the study was terminated early, enrollment was ended at 37 participants instead of the initially planned 126 participants, and a planned interim analysis based on these 37 participants was the only analysis performed for the study. The study duration was also shortened from an estimated 36 months to 20 months overall.",2.0,,"The study was terminated early for business reasons, and not due to concerns regarding safety or lack of efficacy.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,INDUSTRY,,,,,,,2020,0.0
NCT03493542,,2018-04-04,2020-04-21,,2023-11-09,2018-04-04,2018-04-10,ACTUAL,2020-04-21,2020-05-04,ACTUAL,,,,2023-11-09,2023-11-14,ACTUAL,2018-08-31,ACTUAL,2018-08-31,2023-11,2023-11-30,2023-10-30,ACTUAL,2023-10-30,2019-05-01,ACTUAL,2019-05-01,,INTERVENTIONAL,,,"A Study to Evaluate the Immunogenicity, Safety and Tolerability of Quadrivalent Human Papillomavirus Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years (V501-213)","A Phase 3 Open-Label Clinical Trial to Study the Immunogenicity, Safety and Tolerability of Recombinant Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years",COMPLETED,,PHASE3,766.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,f,t,f,,,t,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,INDUSTRY,,,,,,,2023,1.0
NCT03546816,,2018-05-23,2020-08-18,,2021-05-18,2018-05-23,2018-06-06,ACTUAL,2020-08-18,2020-09-07,ACTUAL,,,,2021-05-18,2021-05-20,ACTUAL,2018-05-02,ACTUAL,2018-05-02,2021-05,2021-05-31,2020-02-14,ACTUAL,2020-02-14,2020-01-14,ACTUAL,2020-01-14,,INTERVENTIONAL,,,"Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis","A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus in Adults With Prurigo Nodularis",COMPLETED,,PHASE3,285.0,ACTUAL,Vyne Therapeutics Inc.,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,INDUSTRY,,,,,,,2020,1.0
NCT02725528,,2016-03-22,2023-04-25,,2023-06-23,2016-03-29,2016-04-01,ESTIMATED,2023-06-23,2023-07-18,ACTUAL,,,,2023-06-23,2023-07-18,ACTUAL,2017-07-08,ACTUAL,2017-07-08,2023-06,2023-06-30,2021-12-17,ACTUAL,2021-12-17,2021-12-17,ACTUAL,2021-12-17,,INTERVENTIONAL,EXTEND,"One participant in the limited palmar fasciectomy (LPF) group dropped out immediately after randomization, before baseline outcomes were measured, thus the size of the LPF group is 13, not 14.",Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's,"A Multi-Center, Randomized Controlled Trial Comparing The Clinical Effectiveness and Cost-Effectiveness of Collagenase Injection (Xiaflex) and Palmar Fasciectomy in the Management of Dupuytren's Disease",COMPLETED,,PHASE3,22.0,ACTUAL,McMaster University,"Limitations include small sample size, poor recruitment (due health insurance coverage, treatment preference, and the discontinuation of Xiaflex® in Canada), and poor response rate and outcome data collection due to onset and restriction associated with COVID-19 pandemic.",2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,OTHER,,,,,,,2021,1.0
NCT04677855,,2020-12-14,,,2024-04-08,2020-12-16,2020-12-21,ACTUAL,,,,,,,2024-04-08,2024-04-10,ACTUAL,2021-03-30,ACTUAL,2021-03-30,2024-04,2024-04-30,2023-11-20,ACTUAL,2023-11-20,2023-10-23,ACTUAL,2023-10-23,,INTERVENTIONAL,,,Study of PCUR-101 in Combination With ADT in Patients With mCRPC,A Phase I Study of PCUR-101 in Combination With Androgen Directed Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer,TERMINATED,,PHASE1,7.0,ACTUAL,"Pellficure Pharmaceuticals, Inc",,4.0,,Business Decision due to insufficient enrollment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,INDUSTRY,,,,,,,2023,0.0
NCT04132648,,2019-10-17,,,2023-02-16,2019-10-17,2019-10-21,ACTUAL,,,,,,,2023-02-16,2023-02-21,ACTUAL,2020-11-15,ESTIMATED,2020-11-15,2023-02,2023-02-28,2021-11-01,ESTIMATED,2021-11-01,2021-11-01,ESTIMATED,2021-11-01,,INTERVENTIONAL,,,Curcumin and Exercise in Chronic Kidney Disease,Vasoconstrictor Responsiveness in Contracting Muscle of CKD: Influence of Acute Curcumin Supplementation,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Iowa,,2.0,,PI left the Institution,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,OTHER,,,,,,,2021,0.0
NCT04102501,,2019-09-23,2022-04-06,,2022-05-04,2019-09-23,2019-09-25,ACTUAL,2022-05-04,2022-05-27,ACTUAL,,,,2022-05-04,2022-05-27,ACTUAL,2019-10-30,ACTUAL,2019-10-30,2022-04,2022-04-30,2021-08-23,ACTUAL,2021-08-23,2021-08-23,ACTUAL,2021-08-23,,INTERVENTIONAL,,,"A Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia","A Randomized, Double-Blind, Controlled, Phase 2/3 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia",COMPLETED,,PHASE3,65.0,ACTUAL,"Retrotope, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,INDUSTRY,,,,,,,2021,1.0
NCT01553071,,2012-03-07,,,2022-03-17,2012-03-09,2012-03-13,ESTIMATED,,,,,,,2022-03-17,2022-03-31,ACTUAL,2016-11,,2016-11-30,2022-03,2022-03-31,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Phase I Trial of IV Fenretinide (4-HPR) Plus IV Safingol for Patients With Relapsed Malignancies,Phase I Trial of Intravenous Fenretinide (4-HPR) Plus Intravenous Safingol for Patients With Relapsed Malignancies,TERMINATED,,PHASE1,16.0,ACTUAL,South Plains Oncology Consortium,,1.0,,drug supply issues during COVID-19,f,,,,t,,,,,,,,,,,,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,NETWORK,,,,,,,2020,0.0
NCT04429321,,2020-06-09,,,2024-04-25,2020-06-09,2020-06-12,ACTUAL,,,,,,,2024-04-25,2024-04-26,ACTUAL,2020-08-26,ACTUAL,2020-08-26,2024-04,2024-04-30,2024-01-31,ACTUAL,2024-01-31,2024-01-31,ACTUAL,2024-01-31,,INTERVENTIONAL,,,Nivolumab + Ipilimumab With Immunostimulatory Embolization for Stage 4 Renal Cell Carcinoma With Unresected Primary,UPCC06820 Phase 1 Trial of Nivolumab + Ipilimumab With Immunostimulatory Embolization for Stage 4 Renal Cell Carcinoma With Unresected Primary,TERMINATED,,PHASE1,1.0,ACTUAL,Abramson Cancer Center at Penn Medicine,,1.0,,failure to accrue,f,,,,f,t,t,,,f,,,,,,NO,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,OTHER,,,,,,,2024,0.0
NCT04698915,,2021-01-05,2024-03-01,,2024-04-25,2021-01-05,2021-01-07,ACTUAL,2024-04-25,2024-05-21,ACTUAL,,,,2024-04-25,2024-05-21,ACTUAL,2021-05-07,ACTUAL,2021-05-07,2024-04,2024-04-30,2023-11-30,ACTUAL,2023-11-30,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,,Modified Intent to Treat Population that includes all randomized subjects that received at least one dose of GC4711/Placebo,Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer,"GRECO-2: A Randomized, Phase 2b Study of GC4711 in Combination With Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Unresectable or Borderline Resectable Nonmetastatic Pancreatic Cancer",TERMINATED,,PHASE2,177.0,ACTUAL,"Galera Therapeutics, Inc.",Study was terminated early by the Sponsor based on a futility analysis that was conducted in which the trial met the prespecified early termination rules. The last randomized subject did not complete protocol therapy but was followed for safety for a period of 30 days post the last administration of GC4711/Placebo +SBRT.,2.0,,Futility Analysis,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,INDUSTRY,,,,,,,2023,0.0
NCT04819360,,2020-12-13,,,2024-09-26,2021-03-25,2021-03-26,ACTUAL,,,,,,,2024-09-26,2024-09-27,ACTUAL,2021-06-01,ACTUAL,2021-06-01,2022-02,2022-02-28,2024-04-21,ACTUAL,2024-04-21,2022-03-09,ACTUAL,2022-03-09,,INTERVENTIONAL,SEPTOX,,Botulinum Toxin a Vs Anticholinergic Treatment of Neurogenic Overactive Bladder in Patients with Multiple Sclerosis,Injections of Botulinum Toxin a or Anticholinergic Treatment As First Line Therapy to Treat Neurogenic Overactive Bladder in Patients with Multiple Sclerosis,TERMINATED,,PHASE4,1.0,ACTUAL,Centre Hospitalier Universitaire Vaudois,,2.0,,Lack of recruitment,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,OTHER,,,,,,,2024,0.0
NCT03639610,,2018-08-14,2022-09-26,,2023-03-08,2018-08-20,2018-08-21,ACTUAL,2023-02-09,2023-03-09,ACTUAL,,,,2023-03-08,2023-03-10,ACTUAL,2018-08-28,ACTUAL,2018-08-28,2023-03,2023-03-31,2021-12-22,ACTUAL,2021-12-22,2021-12-22,ACTUAL,2021-12-22,,INTERVENTIONAL,BRIDGE,"Baseline characteristics are shown for the Safety Analysis Set, which is defined as all patients who received at least 1 or partial dose of melflufen or dexamethasone.",PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function,A Study of the Pharmacokinetics of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With Relapsed Refractory Multiple Myeloma and Impaired Renal Function,TERMINATED,,PHASE2,35.0,ACTUAL,Oncopeptides AB,"Between-group comparisons were not performed in this study due the small number of patients in each cohort, as well as differences with regards to some baseline characteristics.",3.0,,The sponsor decided to terminate the study following an FDA request of a partial clinical hold.,f,,,,,t,f,,,,,,,,,NO,,2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,INDUSTRY,,,,,,,2021,0.0
NCT03955471,,2019-05-16,2022-08-16,,2022-08-16,2019-05-17,2019-05-20,ACTUAL,2022-08-16,2022-09-10,ACTUAL,,,,2022-08-16,2022-09-10,ACTUAL,2019-10-03,ACTUAL,2019-10-03,2022-08,2022-08-31,2022-01-12,ACTUAL,2022-01-12,2021-08-18,ACTUAL,2021-08-18,,INTERVENTIONAL,MOONSTONE,,Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer,"A Phase 2 Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Patients With Platinum-Resistant Ovarian Cancer (MOONSTONE)",TERMINATED,,PHASE2,41.0,ACTUAL,"Tesaro, Inc.",,1.0,,The study will not resume based on the results of a planned interim analysis that showed futility,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,INDUSTRY,,,,,,,2022,0.0
NCT03959852,,2019-03-12,,,2020-09-09,2019-05-21,2019-05-22,ACTUAL,,,,,,,2020-09-09,2020-09-11,ACTUAL,2019-11-18,ACTUAL,2019-11-18,2020-09,2020-09-30,2020-06-05,ACTUAL,2020-06-05,2020-06-05,ACTUAL,2020-06-05,,INTERVENTIONAL,,,Sub-Dissociative Ketamine and Fentanyl to Treat Moderate to Severe Pain,A Combination Study With Sub-Dissociative Ketamine and Fentanyl to Treat Moderate to Severe Pain in the Emergency Department,TERMINATED,,PHASE4,6.0,ACTUAL,Mercy Health Ohio,,3.0,,Residency completed.,f,,,,,t,f,,,f,,,,,,,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,OTHER,,,,,,,2020,0.0
NCT04064697,,2019-08-20,,,2024-04-09,2019-08-20,2019-08-22,ACTUAL,,,,,,,2024-04-09,2024-04-10,ACTUAL,2021-04-22,ACTUAL,2021-04-22,2023-06,2023-06-30,2024-02-08,ACTUAL,2024-02-08,2023-11-23,ACTUAL,2023-11-23,,INTERVENTIONAL,CYTOVEDO,,Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab Therapy,Impact of Anti-cytomegalovirus (Valganciclovir) Treatment in the Management of Relapsing Ulcerative Colitis (UC) Requiring Vedolizumab Therapy: a Randomized Clinical Trial Comparing a Strategy With or Without Antiviral Therapy.,TERMINATED,,PHASE3,6.0,ACTUAL,Centre Hospitalier Universitaire de Saint Etienne,,2.0,,low of inclusions,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,OTHER,,,,,,,2024,0.0
NCT03636373,,2018-08-13,2023-02-16,,2023-10-02,2018-08-15,2018-08-17,ACTUAL,2023-10-02,2023-10-27,ACTUAL,,,,2023-10-02,2023-10-27,ACTUAL,2019-10-25,ACTUAL,2019-10-25,2023-10,2023-10-31,2021-08-13,ACTUAL,2021-08-13,2021-08-13,ACTUAL,2021-08-13,,INTERVENTIONAL,,,Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout,"Investigator-Initiated, Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout",TERMINATED,,PHASE4,5.0,ACTUAL,"Rutgers, The State University of New Jersey",Early termination leading to small numbers of subjects analyzed;,2.0,,The Sponsor has decided to stop funding this study due to lack of enrollment during COVID-19 pandemic and decreased interest in funding investigator initiated studies pertaining to the study drug,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,OTHER,,,,,,,2021,0.0
NCT04146363,,2019-10-29,2022-06-20,,2022-11-02,2019-10-30,2019-10-31,ACTUAL,2022-08-04,2022-08-29,ACTUAL,,,,2022-11-02,2022-11-30,ACTUAL,2019-09-24,ACTUAL,2019-09-24,2022-11,2022-11-30,2022-05-03,ACTUAL,2022-05-03,2021-06-21,ACTUAL,2021-06-21,,INTERVENTIONAL,,All randomized participants.,Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1),"A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis",COMPLETED,,PHASE3,424.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,INDUSTRY,,,,,,,2022,1.0
NCT03610490,,2018-07-24,,,2024-08-22,2018-07-31,2018-08-01,ACTUAL,,,,,,,2024-08-22,2024-08-26,ACTUAL,2018-08-17,ACTUAL,2018-08-17,2024-08,2024-08-31,2024-08-21,ACTUAL,2024-08-21,2024-08-21,ACTUAL,2024-08-21,,INTERVENTIONAL,,,"Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma",Clinical Study to Assess Efficacy and Safety of MDA-TIL (Autologous Expanded Tumor Infiltrating Lymphocytes) Across Multiple Tumor Types,TERMINATED,,PHASE2,60.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Lack of Efficacy,,,,,f,t,f,,,f,,,,,,,,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,OTHER,,,,,,,2024,0.0
NCT04989816,,2021-07-14,,,2024-05-06,2021-08-03,2021-08-04,ACTUAL,,,,,,,2024-05-06,2024-05-07,ACTUAL,2021-08-20,ACTUAL,2021-08-20,2024-04,2024-04-30,2024-02-28,ACTUAL,2024-02-28,2023-06-16,ACTUAL,2023-06-16,,INTERVENTIONAL,DG-06,,Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens,A Single-arm Study of Trastuzumab Deruxtecan (T-DXd) Monotherapy for Patients With HER2-expressing Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Who Have Received 2 or More Prior Regimens (DESTINY-Gastric06),COMPLETED,,PHASE2,95.0,ACTUAL,AstraZeneca,,1.0,,,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . A Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,INDUSTRY,,,,,,,2024,1.0
NCT02706249,,2016-03-03,2021-03-25,,2021-07-06,2016-03-07,2016-03-11,ESTIMATED,2021-05-17,2021-06-10,ACTUAL,,,,2021-07-06,2021-07-08,ACTUAL,2016-04,,2016-04-30,2021-07,2021-07-31,2021-06-07,ACTUAL,2021-06-07,2020-12-07,ACTUAL,2020-12-07,,INTERVENTIONAL,,,Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients,"A Randomized, Phase II Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients",COMPLETED,,PHASE2,50.0,ACTUAL,Dana-Farber Cancer Institute,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 23:06:12.108145,2024-10-15 23:06:12.108145,OTHER,,,,,,,2021,1.0
NCT04031729,,2019-07-22,2024-03-22,,2024-04-26,2019-07-23,2019-07-24,ACTUAL,2024-04-26,2024-05-24,ACTUAL,,,,2024-04-26,2024-05-24,ACTUAL,2019-09-12,ACTUAL,2019-09-12,2024-04,2024-04-30,2023-02-23,ACTUAL,2023-02-23,2023-02-23,ACTUAL,2023-02-23,,INTERVENTIONAL,,,Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease,Aspirin in Adults With Nonalcoholic Fatty Liver Disease,COMPLETED,,PHASE1/PHASE2,80.0,ACTUAL,Massachusetts General Hospital,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,OTHER,,,,,,,2023,1.0
NCT02311920,,2014-12-08,,,2023-01-07,2014-12-08,2014-12-09,ESTIMATED,,,,,,,2023-01-07,2023-01-10,ACTUAL,2015-04-16,ACTUAL,2015-04-16,2023-01,2023-01-31,2022-12-22,ACTUAL,2022-12-22,2017-12-31,ACTUAL,2017-12-31,,INTERVENTIONAL,,,Ipilimumab and/or Nivolumab in Combination With Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma,"Phase I Study of Ipilimumab, Nivolumab, and the Combination in Patients With Newly Diagnosed Glioblastoma",COMPLETED,,PHASE1,32.0,ACTUAL,National Cancer Institute (NCI),,3.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,NIH,,,,,,,2022,1.0
NCT03655236,,2018-08-18,,,2024-07-15,2018-08-29,2018-08-31,ACTUAL,,,,,,,2024-07-15,2024-07-18,ACTUAL,2019-02-18,ACTUAL,2019-02-18,2024-07,2024-07-31,2024-06-06,ACTUAL,2024-06-06,2024-04-08,ACTUAL,2024-04-08,,INTERVENTIONAL,,,PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson's Disease",TERMINATED,,PHASE2,513.0,ACTUAL,Sun Pharma Advanced Research Company Limited,,3.0,,Terminated based on study outcomes,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,INDUSTRY,,,,,,,2024,0.0
NCT01700946,,2012-10-01,2022-06-07,,2022-09-13,2012-10-02,2012-10-04,ESTIMATED,2022-09-13,2022-09-28,ACTUAL,,,,2022-09-13,2022-09-28,ACTUAL,2013-04-15,ACTUAL,2013-04-15,2022-09,2022-09-30,2021-07-24,ACTUAL,2021-07-24,2021-07-24,ACTUAL,2021-07-24,,INTERVENTIONAL,,All participants enrolled on study.,Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma,A Phase II Study of Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma,COMPLETED,,PHASE2,80.0,ACTUAL,St. Jude Children's Research Hospital,,2.0,,,f,,,,f,t,t,t,,,,,,,,,,2024-10-15 12:18:47.565019,2024-10-15 12:18:47.565019,OTHER,,,,,,,2021,1.0
NCT03095118,,2017-03-20,2021-06-28,,2022-08-26,2017-03-23,2017-03-29,ACTUAL,2021-06-28,2021-07-16,ACTUAL,,,,2022-08-26,2022-08-31,ACTUAL,2017-09-07,ACTUAL,2017-09-07,2022-08,2022-08-31,2020-05-12,ACTUAL,2020-05-12,2019-10-14,ACTUAL,2019-10-14,,INTERVENTIONAL,,,Daratumumab in Treatment of PGNMID and C3 GN,Single-center Phase 2 Open-label Trial Evaluating Efficacy and Safety of Daratumumab in Treatment of Patients With Proliferative Glomerulonephritis With Monoclonal Immune Deposits and C3 Glomerulopathy Associated With Monoclonal Gammopathy,COMPLETED,,PHASE2,12.0,ACTUAL,Mayo Clinic,,1.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,OTHER,,,,,,,2020,1.0
NCT03760614,,2018-11-26,,,2021-01-13,2018-11-29,2018-11-30,ACTUAL,,,,,,,2021-01-13,2021-01-15,ACTUAL,2021-01,ESTIMATED,2021-01-31,2021-01,2021-01-31,2022-11,ESTIMATED,2022-11-30,2022-07,ESTIMATED,2022-07-31,,INTERVENTIONAL,,,A Study of Entinostat and FOLFOX in Subjects With Pancreatic Adenocarcinoma,A Phase Ib Study of Entinostat and FOLFOX in Subjects With Pancreatic Adenocarcinoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,Abramson Cancer Center at Penn Medicine,,1.0,,Lack of Funding,,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,OTHER,,,,,,,2022,0.0
NCT05445882,,2022-07-02,,,2024-04-01,2022-07-05,2022-07-06,ACTUAL,,,,,,,2024-04-01,2024-04-02,ACTUAL,2024-04-01,ACTUAL,2024-04-01,2021-04,2021-04-30,2024-04-01,ACTUAL,2024-04-01,2024-04-01,ACTUAL,2024-04-01,,INTERVENTIONAL,,,N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer,A Phase II Study of N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,"Closed by study team, no subjects enrolled.",f,,,,,t,f,,,,,,Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.,Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.,,YES,".All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.",2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,NIH,,,,,,,2024,0.0
NCT04252248,,2020-01-28,,,2021-09-28,2020-01-31,2020-02-05,ACTUAL,,,,,,,2021-09-28,2021-10-06,ACTUAL,2019-10-11,ACTUAL,2019-10-11,2021-09,2021-09-30,2021-06-15,ACTUAL,2021-06-15,2021-06-15,ACTUAL,2021-06-15,,INTERVENTIONAL,DERANO,,Decitabine Treatment in HPV-Induced Anogenital and Head and Neck Cancer Patients After Radiotherapy or as Novel Late Salvage,Decitabine Treatment in HPV-Induced Anogenital and Head and Neck Cancer Patients After Radiotherapy or as Novel Late Salvage (DERANO),TERMINATED,,PHASE1,3.0,ACTUAL,University Hospital Heidelberg,,2.0,,Organizational reasons,f,,,,t,f,f,,,,,,,,,YES,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,OTHER,,,,,,,2021,0.0
NCT03456882,,2018-02-02,2022-10-19,,2023-04-20,2018-02-28,2018-03-07,ACTUAL,2023-04-20,2023-04-21,ACTUAL,,,,2023-04-20,2023-04-21,ACTUAL,2017-05-30,ACTUAL,2017-05-30,2023-03,2023-03-31,2021-05-30,ACTUAL,2021-05-30,2020-11-23,ACTUAL,2020-11-23,,INTERVENTIONAL,RNS60,,The Effect of RNS60 on ALS Biomarkers,The Effect of RNS60 on ALS Biomarkers,COMPLETED,,PHASE2,147.0,ACTUAL,Mario Negri Institute for Pharmacological Research,"The study was limited by the COVID-19 outbreak that started in Italy in February 2020. The pandemic caused restrictions in terms of participant access to trial sites and limitations in the performance of respiratory function tests. This context led to missing visits and missing data.~Also, the drug administration route that required weekly visits to the participating center, with significant discomfort for disabled patients.",2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,OTHER,,,,,,,2021,1.0
NCT03625141,,2018-08-02,2022-07-05,,2024-04-05,2018-08-07,2018-08-10,ACTUAL,2023-06-16,2024-02-08,ACTUAL,,,,2024-04-05,2024-04-11,ACTUAL,2018-12-13,ACTUAL,2018-12-13,2024-04,2024-04-30,2023-04-13,ACTUAL,2023-04-13,2021-06-07,ACTUAL,2021-06-07,,INTERVENTIONAL,,,A Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases,A Phase II Two Cohort Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases,COMPLETED,,PHASE2,80.0,ACTUAL,Hoffmann-La Roche,"The Sponsor decided to discontinue enrollment into Cohort 1, which was communicated in a Dear Investigator Letter dated 9 July 2019.",2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,INDUSTRY,,,,,,,2023,1.0
NCT02558231,,2015-09-22,2020-08-26,,2021-03-22,2015-09-22,2015-09-23,ESTIMATED,2020-08-26,2020-09-11,ACTUAL,,,,2021-03-22,2021-04-13,ACTUAL,2016-05-01,ACTUAL,2016-05-01,2021-03,2021-03-31,2020-04-20,ACTUAL,2020-04-20,2019-08-29,ACTUAL,2019-08-29,,INTERVENTIONAL,TRITON,Full Analysis Set (FAS) includes all randomized participants.,The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension,"The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b Study",COMPLETED,,PHASE3,247.0,ACTUAL,Actelion,The main limitation of the sponsor's findings was that analyses of disease progression and mortality were exploratory due to the testing hierarchy and the post hoc nature of the analyses. The study was not powered to show significant differences for the disease progression related endpoint. Another limitation was the availability of hemodynamic assessments only for Week 26 timepoint.,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,INDUSTRY,,,,,Number,,2020,1.0
NCT05071313,,2021-09-28,2023-08-14,2023-04-17,2023-10-11,2021-09-28,2021-10-08,ACTUAL,2023-08-14,2023-09-13,ACTUAL,,2023-04-24,ACTUAL,2023-10-11,2023-10-13,ACTUAL,2021-10-04,ACTUAL,2021-10-04,2023-10,2023-10-31,2022-10-11,ACTUAL,2022-10-11,2022-04-20,ACTUAL,2022-04-20,,INTERVENTIONAL,,"The full analysis set (FAS) included all participants who received at least 1 study vaccination, regardless of the occurrence of protocol deviations and vaccine type (seasonal influenza, Ad26/protein preF RSV vaccine, or placebo).","A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older","A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older",COMPLETED,,PHASE3,777.0,ACTUAL,Janssen Vaccines & Prevention B.V.,,2.0,,,f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,INDUSTRY,,,,,,,2022,1.0
NCT04258683,,2020-02-04,,,2023-08-28,2020-02-04,2020-02-06,ACTUAL,,,,,,,2023-08-28,2023-08-29,ACTUAL,2021-02-17,ACTUAL,2021-02-17,2023-08,2023-08-31,2022-10-31,ACTUAL,2022-10-31,2022-10-31,ACTUAL,2022-10-31,,INTERVENTIONAL,,,"A Study of Pembrolizumab Added to the Standard First-Line Therapy of Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) for NDMM NTE","A Phase 2A Multi Centre, Open Label, Pilot Study Of Pembrolizumab Added to The Standard First-Line Therapy Of Cyclophosphamide, Bortezomib And Dexamethasone (CyBorD) In Newly Diagnosed Multiple Myeloma Patients Not Eligible For Autologous Stem Cell Transplantation",WITHDRAWN,,PHASE2,0.0,ACTUAL,Canadian Myeloma Research Group,,1.0,,Study terminated due to changing treatment landscape,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,OTHER,,,,,,,2022,0.0
NCT05832775,,2022-03-08,,,2023-04-19,2023-04-19,2023-04-27,ACTUAL,,,,,,,2023-04-19,2023-04-27,ACTUAL,2022-05,ESTIMATED,2022-05-31,2023-04,2023-04-30,2023-04,ESTIMATED,2023-04-30,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,,,"Study to Assess the Safety of MRx0029 or MRx0005 Compared to Placebo, in People With Parkinson's","A First-in-human, Double-blind, Placebo-controlled, Multicentre, Cross-over, Phase I Study to Assess Safety and Tolerability of Repeat Oral Administrations of MRx0029 OR MRx0005 in Adult Participants With Idiopathic Parkinson's Disease",WITHDRAWN,,PHASE1,0.0,ACTUAL,4D pharma plc,,4.0,,Sponsor insolvency,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,INDUSTRY,,,,,,,2023,0.0
NCT03516084,,2018-04-23,,,2020-12-16,2018-04-23,2018-05-04,ACTUAL,,,,,,,2020-12-16,2020-12-21,ACTUAL,2018-08-20,ACTUAL,2018-08-20,2020-12,2020-12-31,2020-03-20,ACTUAL,2020-03-20,2020-02-21,ACTUAL,2020-02-21,,INTERVENTIONAL,,,A Study of Niraparib as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer,"A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Study of ZL-2306 (Niraparib) as Maintenance Therapy Following First-line Platinum-based Chemotherapy in Patients With Extensive-stage Disease Small Cell Lung Cancer (ED-SCLC) to Evaluate the Efficacy and Safety",TERMINATED,,PHASE3,185.0,ACTUAL,"Zai Lab (Hong Kong), Ltd.",,2.0,,"As the treatment model of extensive-stage small cell lung cancer changed rapidly and the enrollment speed significantly lower than expected, ZaiLab decided to terminate this study",f,,,,t,f,f,,,f,,,,,,,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,INDUSTRY,,,,,,,2020,0.0
NCT02953509,,2016-11-01,,,2024-05-22,2016-11-01,2016-11-02,ESTIMATED,,,,,,,2024-05-22,2024-05-23,ACTUAL,2016-11-21,ACTUAL,2016-11-21,2024-05,2024-05-31,2024-03-25,ACTUAL,2024-03-25,2024-03-25,ACTUAL,2024-03-25,,INTERVENTIONAL,,,Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma,A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Rituximab or Rituximab + Chemotherapy in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma,TERMINATED,,PHASE1/PHASE2,178.0,ACTUAL,Gilead Sciences,,5.0,,Study terminated early due to the magrolimab program discontinuation.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,INDUSTRY,,,,,,,2024,0.0
NCT00047008,,2002-10-03,2014-07-28,,2023-07-03,2003-01-26,2003-01-27,ESTIMATED,2014-07-28,2014-08-15,ESTIMATED,,,,2023-07-03,2023-07-07,ACTUAL,2002-07,ACTUAL,2002-07-31,2023-04,2023-04-30,2022-05-20,ACTUAL,2022-05-20,2010-06,ACTUAL,2010-06-30,,INTERVENTIONAL,,Eligible patients who did not withdraw consent.,Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer,A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas,COMPLETED,,PHASE3,743.0,ACTUAL,Radiation Therapy Oncology Group,Local-regional failure and disease-free survival were additionally analyzed with the definition of failure used in the Meta-Analysis of Radiotherapy in Carcinomas of Head and Neck (MARCH) Collaborative Group and the Meta-Analysis of Chemotherapy in Head and Neck Cancer (MACH-NC) Collaborative Group publications. These modified outcome measures are labeled Alternate Definition.,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,NETWORK,,,,,,,2022,1.0
NCT03494114,,2018-03-15,,,2021-08-10,2018-04-10,2018-04-11,ACTUAL,,,,,,,2021-08-10,2021-08-11,ACTUAL,2018-11-29,ACTUAL,2018-11-29,2021-08,2021-08-31,2021-01-13,ACTUAL,2021-01-13,2019-11-20,ACTUAL,2019-11-20,,INTERVENTIONAL,,,Imaging Activated Macrophages in the Lungs,Imaging Activated Macrophages in the Lungs,TERMINATED,,PHASE1,13.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,Funding has ended and unable to recruit due to COVID 19,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,OTHER,,,,,,,2021,0.0
NCT03280277,,2017-05-23,,,2021-09-02,2017-09-08,2017-09-12,ACTUAL,,,,,,,2021-09-02,2021-09-10,ACTUAL,2018-04-27,ACTUAL,2018-04-27,2021-09,2021-09-30,2021-08-26,ACTUAL,2021-08-26,2021-08-26,ACTUAL,2021-08-26,,INTERVENTIONAL,,,Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Locally Advanced Rectal Cancer,Novel Imaging of Lymph Nodes in Patients With Rectal Cancer Using Ferumoxytol Enhanced MRI,TERMINATED,,EARLY_PHASE1,2.0,ACTUAL,OHSU Knight Cancer Institute,,1.0,,low accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,OTHER,,,,,,,2021,0.0
NCT03250299,,2017-07-28,2023-06-02,,2024-02-26,2017-08-14,2017-08-15,ACTUAL,2024-02-26,2024-06-24,ACTUAL,,,,2024-02-26,2024-06-24,ACTUAL,2017-12-15,ACTUAL,2017-12-15,2024-02,2024-02-29,2022-08-24,ACTUAL,2022-08-24,2022-06-03,ACTUAL,2022-06-03,,INTERVENTIONAL,,,Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma,Phase I Study to Determine the Safety and Tolerability of the Oral Microtubule Destabilizer BAL101553 in Combination With Standard Radiation in Patients With MGMT Promoter Unmethylated Newly Diagnosed Glioblastoma,TERMINATED,,PHASE1,26.0,ACTUAL,Basilea Pharmaceutica,,1.0,,Due to the National Cancer Institute's (NCI)-mandated termination of the Adult Brain Tumor Consortium which was conducting the study,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,INDUSTRY,,,,,,,2022,0.0
NCT04654689,,2020-11-13,,,2023-10-31,2020-12-03,2020-12-04,ACTUAL,,,,,,,2023-10-31,2023-11-01,ACTUAL,2021-11-20,ACTUAL,2021-11-20,2023-10,2023-10-31,2023-02-04,ACTUAL,2023-02-04,2022-11-12,ACTUAL,2022-11-12,,INTERVENTIONAL,,,Impact of the Combined Treatment of Liposomed Polyphenols With G04CB02 on the ALS Patients,Impact of the Combined Treatment of Curcumin and Resveratrol Liposomed Polyphenols With G04CB02 on the Clinical Improvement of ALS Patients,COMPLETED,,PHASE2,90.0,ACTUAL,Fundación Universidad Católica de Valencia San Vicente Mártir,,2.0,,,f,,,,,t,f,,,t,,,,,,YES,Variables related to inflammation and oxidation:~* Quantitative measurement of plasma IL-6 and TNF-alpha.~* Quantitative measurement of plasma PCR.~* Quantitative measurement of plasma haptoglobin.~* Quantitative measurement of TEAC (oxidation).~* Quantitative measurement of plasma 8-oxoG.~* Quantitative measurement of plasma MDA.~Variables for cognitive and behavioural assessment:~* Edinburgh Cognitive and Behavioral ALS Screen~* Frontal Assessment Battery (FAB),2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,OTHER,,,,,,,2023,1.0
NCT03503968,,2018-03-21,,,2023-02-13,2018-04-11,2018-04-20,ACTUAL,,,,,,,2023-02-13,2023-02-15,ACTUAL,2018-03-27,ACTUAL,2018-03-27,2023-02,2023-02-28,2022-07-15,ACTUAL,2022-07-15,2022-06-28,ACTUAL,2022-06-28,,INTERVENTIONAL,,,TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms,"A Phase I/II, Open-Label, Non-Randomized, Multicentre, Dose-Escalation Clinical Trial With Control Group to Evaluate the Safety, Feasibility and Preliminary Efficacy of PRAME TCR Modified T Cells, MDG1011, in Subjects With High Risk Myeloid and Lymphoid Neoplasms",TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,Medigene AG,,5.0,,The clinical trial is terminated after the completion of phase I without moving to Phase II.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,INDUSTRY,,,,,,,2022,0.0
NCT04348474,,2020-04-13,,,2022-11-03,2020-04-13,2020-04-16,ACTUAL,,,,,,,2022-11-03,2022-11-04,ACTUAL,2020-04-20,ACTUAL,2020-04-20,2022-11,2022-11-30,2023-07,ESTIMATED,2023-07-31,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19,"Open Label, Multicentric, Non Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Mild Acute Respiratory Syndrome (COVID-19) Caused by SARS-CoV-2 Virus",SUSPENDED,,EARLY_PHASE1,200.0,ESTIMATED,Azidus Brasil,,1.0,,"Azidus, the CRO hired for this study by Prevent Senior has lost the interest to conduct this study.",f,,,,t,f,f,,,,,,,,,NO,"It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.",2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,INDUSTRY,,,,,,,2023,0.0
NCT04396847,,2020-02-03,2022-04-05,,2022-08-16,2020-05-15,2020-05-21,ACTUAL,2022-08-16,2022-09-07,ACTUAL,,,,2022-08-16,2022-09-07,ACTUAL,2019-10-25,ACTUAL,2019-10-25,2022-08,2022-08-31,2020-02-26,ACTUAL,2020-02-26,2020-02-26,ACTUAL,2020-02-26,,INTERVENTIONAL,,"5 participants provided informed consent. Due to participant no-shows and the cancelation of the study, only one participant started study medication.",Laboratory Screening of Lorcaserin for Alcohol Use Disorder,Human Laboratory Screening of Lorcaserin in Smokers With Alcohol Use Disorder,TERMINATED,,PHASE2,5.0,ACTUAL,The Mind Research Network,,2.0,,Medication removed from the U.S. market by the The Food and Drug Administration,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,OTHER,,,,,,,2020,0.0
NCT03965871,,2019-05-21,,,2021-03-18,2019-05-26,2019-05-29,ACTUAL,,,,,,,2021-03-18,2021-03-19,ACTUAL,2019-03-28,ACTUAL,2019-03-28,2021-03,2021-03-31,2021-02-19,ACTUAL,2021-02-19,2021-01-03,ACTUAL,2021-01-03,,INTERVENTIONAL,,,"Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression","A Multicentre, Double-blind, Randomised, Placebo - Controlled Phase II Study to Assess Efficacy, Safety and Pharmacokinetics of Inhaled Esketamine in Subject With Treatment-resistant Bipolar Depression",COMPLETED,,PHASE2,88.0,ACTUAL,Celon Pharma SA,,4.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,INDUSTRY,,,,,,,2021,1.0
NCT04174677,,2019-11-05,,,2024-06-18,2019-11-21,2019-11-22,ACTUAL,,,,,,,2024-06-18,2024-06-21,ACTUAL,2019-12-27,ACTUAL,2019-12-27,2024-06,2024-06-30,2022-04,ESTIMATED,2022-04-30,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,"Safety and Tolerability of Inebilizumab, VIB4920, or the Combination in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor","A Phase 2 Open-label, Prospective, Randomized Study of Inebilizumab, VIB4920, or the Combination to Evaluate Safety and Tolerability in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor",WITHDRAWN,,PHASE2,0.0,ACTUAL,Amgen,,3.0,,Stopped due to no enrollment,f,,,,,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,INDUSTRY,,,,,,,2022,0.0
NCT03828448,,2019-01-31,2023-05-16,,2023-07-03,2019-01-31,2019-02-04,ACTUAL,2023-07-03,2023-07-24,ACTUAL,,,,2023-07-03,2023-07-24,ACTUAL,2019-07-10,ACTUAL,2019-07-10,2023-07,2023-07-31,2022-05-31,ACTUAL,2022-05-31,2022-05-16,ACTUAL,2022-05-16,,INTERVENTIONAL,,,Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma,A Phase II Study Evaluating the Safety and Efficacy of Umbralisib (TGR-1202) in Combination With Ublituximab in Patients With Treatment Naïve Follicular Lymphoma and Small Lymphocytic Lymphoma,TERMINATED,,PHASE2,34.0,ACTUAL,"TG Therapeutics, Inc.","Due to sponsor's business decision, the clinical trial was terminated by the sponsor prematurely. No analysis was done at the termination of the trial, therefore, outcome, and safety data are not available and the numbers of participants analyzed are reported as 0.",1.0,,Strategic/Business Decision,f,,,,f,t,f,,,,,,,,,,,2024-10-16 18:21:39.473934,2024-10-16 18:21:39.473934,INDUSTRY,,,,,,,2022,0.0
NCT03326245,,2017-10-28,2024-02-29,,2024-04-29,2017-10-28,2017-10-31,ACTUAL,2024-04-29,2024-05-28,ACTUAL,,,,2024-04-29,2024-05-28,ACTUAL,2018-01-29,ACTUAL,2018-01-29,2023-10-27,2023-10-27,2024-02-08,ACTUAL,2024-02-08,2021-12-13,ACTUAL,2021-12-13,,INTERVENTIONAL,,,Dopaminergic Modulation of Brain Activation Using Simultaneous PET/Pharmacological MRI,Dopaminergic Modulation of Brain Activation Using Simultaneous PET/Pharmacological MRI,COMPLETED,,PHASE1,25.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,,f,,,,,t,f,,,,,,,,,NO,.Data is analyzed by subject group and not on an individual basis.,2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,NIH,,,,,,,2024,1.0
NCT03893448,,2019-03-26,2022-01-11,,2023-07-20,2019-03-26,2019-03-28,ACTUAL,2022-02-25,2022-03-25,ACTUAL,,,,2023-07-20,2023-07-28,ACTUAL,2019-06-19,ACTUAL,2019-06-19,2023-07,2023-07-31,2021-05-24,ACTUAL,2021-05-24,2021-05-24,ACTUAL,2021-05-24,,INTERVENTIONAL,PNEU-PED,,"Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)","A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)",COMPLETED,,PHASE3,1720.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,INDUSTRY,,,,,,,2021,1.0
NCT04315311,,2020-03-18,,,2021-11-03,2020-03-18,2020-03-19,ACTUAL,,,,,,,2021-11-03,2021-11-08,ACTUAL,2020-05-06,ESTIMATED,2020-05-06,2021-11,2021-11-30,2021-09-22,ACTUAL,2021-09-22,2021-09-22,ACTUAL,2021-09-22,,INTERVENTIONAL,,,"Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer","A Phase 4 Open-Label Single-Arm Study To Evaluate The Use Of CREON In Subjects With EPI Due To Etiologies Other Than Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer",WITHDRAWN,,PHASE4,0.0,ACTUAL,AbbVie,,1.0,,Business Decision,f,,,,f,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,INDUSTRY,,,,,,,2021,0.0
NCT03196921,,2017-06-19,,,2019-03-06,2017-06-20,2017-06-23,ACTUAL,,,,,,,2019-03-06,2019-03-08,ACTUAL,2018-10-01,ESTIMATED,2018-10-01,2019-03,2019-03-31,2020-03-01,ESTIMATED,2020-03-01,2019-10-01,ESTIMATED,2019-10-01,,INTERVENTIONAL,ORACLE,,Efficacy and Safety of Oral Encochleated Amphotericin B for the Treatment of Cryptococcal Infection,A Prospective Cohort to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB/MAT2203) for the Treatment of Cryptococcal Infection,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Matinas BioPharma Nanotechnologies, Inc.",,2.0,,Protocol redundancy,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,INDUSTRY,,,,,,,2020,0.0
NCT03062449,,2017-02-20,2022-07-20,,2024-06-08,2017-02-20,2017-02-23,ACTUAL,2024-06-08,2024-07-03,ACTUAL,,,,2024-06-08,2024-07-03,ACTUAL,2017-03-01,ACTUAL,2017-03-01,2024-06,2024-06-30,2021-07-20,ACTUAL,2021-07-20,2021-07-20,ACTUAL,2021-07-20,,INTERVENTIONAL,LSPI-2,All study participants are grouped for the baseline measure and reported for all participants collectively. The study was closed by the PI and institution prior to study completion because the stability of the investigational product could not be verified.,Phase IIa L-serine Trial for eAD,"A Phase IIa Proof of Concept, Randomized, Double-blind, Placebo-controlled Study of the Effects of L-serine on Early Stage Alzheimer's Disease Patients",TERMINATED,,PHASE2,29.0,ACTUAL,Dartmouth-Hitchcock Medical Center,"The Sponsor-Investigator (PI) and institutional officials determined that the available investigational agent stability data of provided by the product's manufacturer was unsatisfactory. The study was closed by the PI and institution prior to study completion. Data are potentially invalid due to the inadequate stability testing performed by the manufacturer, as the sponsor-investigator is unable to confirm that the investigational product remained stable over time.",2.0,,Stability of investigational product could not be established.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,OTHER,,,,,,,2021,0.0
NCT04060342,,2019-08-09,,,2022-08-17,2019-08-14,2019-08-19,ACTUAL,,,,,,,2022-08-17,2022-08-18,ACTUAL,2019-08-13,ACTUAL,2019-08-13,2022-08,2022-08-31,2022-04-11,ACTUAL,2022-04-11,2022-04-11,ACTUAL,2022-04-11,,INTERVENTIONAL,,,GB1275 Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma,"A Phase 1/2, First-in-Human, Open-label, Dose Escalation Study of GB1275 Monotherapy and in Combination With an Anti-PD-1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma, Followed by Basket Expansion of GB1275 With Standard of Care or in Combination With an Anti-PD-1 Antibody in Patients With Specified Metastatic Solid Tumors",TERMINATED,,PHASE1,61.0,ACTUAL,Gossamer Bio Inc.,,6.0,,No clear benefit of GB1275 was observed either as monotherapy or in combination with pembrolizumab.,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,INDUSTRY,,,,,,,2022,0.0
NCT04605159,,2020-10-22,2024-06-13,,2024-08-14,2020-10-22,2020-10-27,ACTUAL,2024-08-14,2024-09-05,ACTUAL,,,,2024-08-14,2024-09-05,ACTUAL,2020-11-20,ACTUAL,2020-11-20,2024-08,2024-08-31,2023-06-14,ACTUAL,2023-06-14,2023-06-14,ACTUAL,2023-06-14,,INTERVENTIONAL,GRACE,,"A Phase III, Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers","A Phase III, Randomized, Double-blind, Placebo-controlled Multi-country Study to Demonstrate Efficacy of a Single Dose of Unadjuvanted RSV Maternal Vaccine, Administered IM to Pregnant Women 18 to 49 Years of Age, for Prevention of RSV Associated LRTIs in Their Infants up to 6 Months of Age",TERMINATED,,PHASE3,11194.0,ACTUAL,GlaxoSmithKline,,4.0,,"Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study.",f,,,,t,t,f,,,f,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,INDUSTRY,,,,,,,2023,0.0
NCT04093362,,2019-09-16,,,2024-08-30,2019-09-16,2019-09-18,ACTUAL,,,,,,,2024-08-30,2024-09-05,ACTUAL,2020-03-01,ACTUAL,2020-03-01,2024-08,2024-08-31,2024-04-22,ACTUAL,2024-04-22,2024-04-22,ACTUAL,2024-04-22,,INTERVENTIONAL,FOENIX-CCA3,,Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements,"A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements FOENIX-CCA3",TERMINATED,,PHASE3,10.0,ACTUAL,"Taiho Oncology, Inc.",,2.0,,Due to Poor Recruitment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,INDUSTRY,,,,,,,2024,0.0
NCT04156620,,2019-10-08,2023-11-24,2022-10-14,2024-06-14,2019-11-06,2019-11-07,ACTUAL,2024-01-02,2024-01-23,ACTUAL,,2024-01-23,ACTUAL,2024-06-14,2024-06-18,ACTUAL,2019-12-11,ACTUAL,2019-12-11,2024-06,2024-06-30,2022-12-20,ACTUAL,2022-12-20,2022-02-17,ACTUAL,2022-02-17,,INTERVENTIONAL,,,"Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA","A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial SpondyloArthritis",COMPLETED,,PHASE3,527.0,ACTUAL,Novartis,,2.0,,,f,,,,f,t,f,,,,,,,,https://clinicalstudydatarequest.com/Default.aspx,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,INDUSTRY,,,,,,,2022,1.0
NCT04881760,,2021-05-10,2023-08-23,2023-05-10,2023-08-23,2021-05-10,2021-05-11,ACTUAL,2023-08-23,2023-09-13,ACTUAL,,2023-05-15,ACTUAL,2023-08-23,2023-09-13,ACTUAL,2021-05-20,ACTUAL,2021-05-20,2023-08,2023-08-31,2022-11-22,ACTUAL,2022-11-22,2022-05-16,ACTUAL,2022-05-16,,INTERVENTIONAL,,All randomized participants.,A Study of LY3437943 in Participants Who Have Obesity or Are Overweight,A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities,COMPLETED,,PHASE2,338.0,ACTUAL,Eli Lilly and Company,,7.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,INDUSTRY,,,,,,,2022,1.0
NCT02896192,,2016-08-18,2023-05-18,,2023-08-30,2016-09-06,2016-09-12,ESTIMATED,2023-08-30,2023-09-21,ACTUAL,,,,2023-08-30,2023-09-21,ACTUAL,2017-02-14,ACTUAL,2017-02-14,2023-08,2023-08-31,2020-05-25,ACTUAL,2020-05-25,2020-05-25,ACTUAL,2020-05-25,,INTERVENTIONAL,,The Safety Analysis Set (SAS) Population consisted of participants who received any of the study drug injections and had at least one post-dose safety assessment.,Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity,"An Open-Label, 1-Year Trial, Including a Double-Blind Placebo-Controlled Withdrawal Period, of Setmelanotide (RM-493), a Melanocortin 4 Receptor (MC4R) Agonist, in Early Onset POMC Deficiency Obesity Due to Bi-Allelic Loss-of-Function POMC or PCSK1 Genetic Mutation",COMPLETED,,PHASE3,15.0,ACTUAL,"Rhythm Pharmaceuticals, Inc.","There was no planned comparison to a randomized placebo group given the rarity of monogenic POMC deficiency obesity. To provide support in assessing setmelanotide treatment in this open-label single-arm trial design, individual participants were evaluated during a double-blind placebo-controlled withdrawal phase in which participants served as their own control to assess effects on weight and reported hunger scores.",1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,INDUSTRY,,,,,,,2020,1.0
NCT04925947,,2021-06-08,2024-02-05,,2024-03-28,2021-06-08,2021-06-14,ACTUAL,2024-03-28,2024-04-16,ACTUAL,,,,2024-03-28,2024-04-16,ACTUAL,2021-12-13,ACTUAL,2021-12-13,2024-03,2024-03-31,2023-05-05,ACTUAL,2023-05-05,2023-05-05,ACTUAL,2023-05-05,,INTERVENTIONAL,,,A Study of KN046 in Patients With Thymic Carcinoma Who Failed Immune Checkpoint Inhibitors,Phase II Study of KN046 in Patients With Thymic Carcinoma Who Failed Immune Checkpoint Inhibitors,TERMINATED,,PHASE2,4.0,ACTUAL,Weill Medical College of Cornell University,"This study was terminated early and participant enrollment was low, resulting in a small sample size (N=4). Having a small sample size may reduce statistical reliability and generalizability of results.",1.0,,Data collected did not support the study endpoints,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,OTHER,,,,,,,2023,0.0
NCT04999605,,2021-04-29,,,2024-01-03,2021-08-02,2021-08-11,ACTUAL,,,,,,,2024-01-03,2024-01-05,ACTUAL,2021-06-24,ACTUAL,2021-06-24,2024-01,2024-01-31,2022-06-10,ACTUAL,2022-06-10,2022-06-10,ACTUAL,2022-06-10,,INTERVENTIONAL,,,A Study of AK112 Combined With PARP Inhibitor in the Treatment of Recurrent Ovarian Cancer,Phase Ib/II Clinical Study of Anti-PD-1 and VEGF Bispecific Antibody (AK112) Combined With PARP Inhibitor in the Treatment of Recurrent Ovarian Cancer,TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,Akeso,,1.0,,Too low inclusion rate,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,INDUSTRY,,,,,,,2022,0.0
NCT03954314,,2019-05-15,,,2023-12-01,2019-05-15,2019-05-17,ACTUAL,,,,,,,2023-12-01,2023-12-08,ACTUAL,2019-09-17,ACTUAL,2019-09-17,2023-12,2023-12-31,2023-11-28,ACTUAL,2023-11-28,2023-11-28,ACTUAL,2023-11-28,,INTERVENTIONAL,DEPOSITION,,DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery,Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery (DEPOSITION) Study,TERMINATED,,PHASE3,3242.0,ACTUAL,Population Health Research Institute,,2.0,,"Upon the Data Safety Monitoring Board review of the interim analysis (75% of participants have finished their follow-up) on November 17, 2023, they made a recommendation to stop recruitment into the trial.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,OTHER,,,,,,,2023,0.0
NCT05033912,,2021-08-24,,,2021-10-22,2021-08-31,2021-09-05,ACTUAL,,,,,,,2021-10-22,2021-10-28,ACTUAL,2021-10,ESTIMATED,2021-10-31,2021-10,2021-10-31,2022-05,ESTIMATED,2022-05-31,2022-03,ESTIMATED,2022-03-31,,INTERVENTIONAL,,,A Study of CST-2032 in Subjects With Cognitive Impairment,"An Open-Label Ascending Single-Dose, and Randomized, Double-blind, Placebo-controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CST-2032 in Healthy Volunteers and Subjects With Mild Cognitive Impairment or Parkinson's Disease",WITHDRAWN,,PHASE1,0.0,ACTUAL,"CuraSen Therapeutics, Inc.",,4.0,,Business reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,INDUSTRY,,,,,,,2022,0.0
NCT03326583,,2017-10-06,2021-09-10,,2023-04-19,2017-10-26,2017-10-31,ACTUAL,2023-02-21,2023-03-22,ACTUAL,,,,2023-04-19,2023-05-09,ACTUAL,2017-11-01,ACTUAL,2017-11-01,2023-04,2023-04-30,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia,The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of End Stage Renal Disease Patients With Hyperkalemia,COMPLETED,,PHASE2,27.0,ACTUAL,George Washington University,,1.0,,,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,OTHER,,,,,,,2020,1.0
NCT01640301,,2011-11-29,2022-04-06,,2022-06-28,2012-07-12,2012-07-13,ESTIMATED,2022-05-31,2022-06-23,ACTUAL,,,,2022-06-28,2022-07-14,ACTUAL,2012-12-06,ACTUAL,2012-12-06,2022-06,2022-06-30,2020-03-20,ACTUAL,2020-03-20,2020-03-20,ACTUAL,2020-03-20,,INTERVENTIONAL,,,"Laboratory-Treated T Cells in Treating Patients With High-Risk Relapsed Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia Previously Treated With Donor Stem Cell Transplant",Phase I/II Study of Adoptive Immunotherapy After Allogeneic HCT With Virus Specific CD8+ T Cells That Have Been Transduced to Express a WT1-Specific T Cell Receptor for Patients With Relapsed AML,TERMINATED,,PHASE1/PHASE2,47.0,ACTUAL,Fred Hutchinson Cancer Center,,2.0,,Terminated due to slow accrual.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,OTHER,,,,,,,2020,0.0
NCT04574362,,2020-09-27,2023-03-08,,2023-03-08,2020-09-30,2020-10-05,ACTUAL,2023-03-08,2023-12-14,ACTUAL,,,,2023-03-08,2023-12-14,ACTUAL,2020-10-22,ACTUAL,2020-10-22,2023-03,2023-03-31,2021-12-16,ACTUAL,2021-12-16,2021-11-24,ACTUAL,2021-11-24,,INTERVENTIONAL,,Baseline analysis population included all treated participants (all enrolled participants who took either of the study drug).,Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine,"BHV3000-310: Phase 3: Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine",COMPLETED,,PHASE3,1648.0,ACTUAL,Pfizer,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,INDUSTRY,,,,,,,2021,1.0
NCT05337774,,2022-02-09,,,2024-05-10,2022-04-14,2022-04-20,ACTUAL,,,,,,,2024-05-10,2024-05-14,ACTUAL,2021-06-07,ACTUAL,2021-06-07,2024-05,2024-05-31,2022-04-30,ACTUAL,2022-04-30,2022-04-30,ACTUAL,2022-04-30,,INTERVENTIONAL,,,Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury,Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury,TERMINATED,,PHASE1,18.0,ACTUAL,Life Molecular Imaging SA,,3.0,,study funding period ended March 2022,,,,,,t,f,,,,,,,,,NO,,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,INDUSTRY,,,,,,,2022,0.0
NCT05360238,,2022-04-14,,,2024-07-18,2022-04-29,2022-05-04,ACTUAL,,,,,,,2024-07-18,2024-07-22,ACTUAL,2022-05-24,ACTUAL,2022-05-24,2023-12,2023-12-31,2024-04-12,ACTUAL,2024-04-12,2024-04-12,ACTUAL,2024-04-12,,INTERVENTIONAL,,,"Study to Assess Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory B-Cell NHL or CLL","A Phase 1/2, Open Label, Multicenter Study to Assess the Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory CD20+ B-Cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia",TERMINATED,,PHASE1/PHASE2,20.0,ACTUAL,Mustang Bio,,7.0,,Business reasons,f,,,,t,t,f,,,,,,,,,,,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,INDUSTRY,,,,,,,2024,0.0
NCT04233814,,2020-01-12,,,2022-03-04,2020-01-15,2020-01-18,ACTUAL,,,,,,,2022-03-04,2022-03-07,ACTUAL,2020-01-20,ACTUAL,2020-01-20,2022-03,2022-03-31,2021-12-23,ACTUAL,2021-12-23,2021-12-23,ACTUAL,2021-12-23,,INTERVENTIONAL,,,"Safety, Tolerability and Pharmacokinetic Study of LTI-03 in Healthy Adult Subjects","A Randomized, Double-Blind, Placebo-Controlled, Ph 1a, First-in-Man, Single Ascending Dose & Multiple Ascending Dose Safety, Tolerability and PK Study of a Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Healthy Adult Subjects",COMPLETED,,PHASE1,71.0,ACTUAL,"Lung Therapeutics, Inc",,9.0,,,f,,,,f,t,f,,,t,,,,,,,,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,INDUSTRY,,,,,,,2021,1.0
NCT03831854,,2018-12-03,2021-03-15,,2021-05-12,2019-02-04,2019-02-06,ACTUAL,2021-05-12,2021-06-09,ACTUAL,,,,2021-05-12,2021-06-09,ACTUAL,2019-01-24,ACTUAL,2019-01-24,2021-05,2021-05-31,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine,The Role of Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine Use,COMPLETED,,PHASE3,46.0,ACTUAL,The Cleveland Clinic,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,There is no plan to make subjects data available to outside researchers,2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,OTHER,,,,,,,2020,1.0
NCT05435339,,2022-06-23,,,2024-06-07,2022-06-23,2022-06-28,ACTUAL,,,,,,,2024-06-07,2024-06-10,ACTUAL,2022-10-04,ACTUAL,2022-10-04,2024-06,2024-06-30,2024-05-24,ACTUAL,2024-05-24,2024-05-24,ACTUAL,2024-05-24,,INTERVENTIONAL,,,"A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy","First-in-Human, Open-label, Dose-Escalation Trial With an Expansion Cohort to Evaluate the Safety of GEN1053 as Monotherapy in Subjects With Malignant Solid Tumors",TERMINATED,,PHASE1/PHASE2,31.0,ACTUAL,Genmab,,1.0,,Due to strategic evaluation of GEN1053 within the context of Genmab's portfolio,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,INDUSTRY,,,,,,,2024,0.0
NCT01573169,,2012-03-31,2021-01-03,,2021-09-09,2012-04-04,2012-04-06,ESTIMATED,2021-09-09,2021-09-10,ACTUAL,,,,2021-09-09,2021-09-10,ACTUAL,2012-05,,2012-05-31,2021-09,2021-09-30,2020-03,ACTUAL,2020-03-31,2020-03,ACTUAL,2020-03-31,,INTERVENTIONAL,PREVENTIHS,,PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients,PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients,TERMINATED,,PHASE3,73.0,ACTUAL,University Of Perugia,,2.0,,The trial has been terminated prematurely after the randomization of 73 patients due to a lack of funding.,f,,,,t,,,,,,,,,,,,,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,OTHER,,,,,,,2020,0.0
NCT04016116,,2019-06-27,,,2020-05-26,2019-07-09,2019-07-11,ACTUAL,,,,,,,2020-05-26,2020-05-27,ACTUAL,2019-12,ESTIMATED,2019-12-31,2020-05,2020-05-31,2021-12,ESTIMATED,2021-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Dual PD-1 and JAK2 Inhibition in Hematological Malignancies,Study of PD-1 Inhibition With Pemrolizumab Alore or Combined With JAK 2 Inhibition in Myeloproliferative Neoplasm and Hodgkin's Lymphoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,NYU Langone Health,,3.0,,PI left the institution,f,,,,f,t,f,,,,,,,,,,,2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,OTHER,,,,,,,2021,0.0
NCT03728933,,2018-10-31,2023-10-05,2023-07-21,2023-10-05,2018-10-31,2018-11-02,ACTUAL,2023-10-05,2023-10-26,ACTUAL,,2023-08-22,ACTUAL,2023-10-05,2023-10-26,ACTUAL,2018-12-20,ACTUAL,2018-12-20,2023-09,2023-09-30,2022-07-25,ACTUAL,2022-07-25,2022-07-25,ACTUAL,2022-07-25,,INTERVENTIONAL,,The Randomized Set consisted of all participants from the Enrolled Set who have been randomized.,A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause,"A Remote, Double-Blind, Randomized, Placebo-Controlled Study of Rotigotine Transdermal System in Adolescent Subjects With Idiopathic Restless Legs Syndrome",TERMINATED,,PHASE3,23.0,ACTUAL,UCB Pharma,,3.0,,Sponsor decision; Not a safety decision,,,,,f,t,f,,,f,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",https://vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,INDUSTRY,,,,,,,2022,0.0
NCT04577781,,2020-09-30,2022-03-21,,2022-03-21,2020-09-30,2020-10-08,ACTUAL,2022-03-21,2022-07-18,ACTUAL,,,,2022-03-21,2022-07-18,ACTUAL,2020-10-12,ACTUAL,2020-10-12,2022-03,2022-03-31,2021-04-07,ACTUAL,2021-04-07,2021-03-26,ACTUAL,2021-03-26,,INTERVENTIONAL,LADYBUG,Safety analysis set (SAS) consisted of all participants who received at least 1 dose of investigational product.,A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate,"A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate",COMPLETED,,PHASE2,28.0,ACTUAL,Galapagos NV,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,INDUSTRY,,,,,,,2021,1.0
NCT03387761,,2017-11-24,,,2023-10-16,2017-12-22,2018-01-02,ACTUAL,,,,,,,2023-10-16,2023-10-18,ACTUAL,2018-01-15,ACTUAL,2018-01-15,2023-10,2023-10-31,2021-09-13,ACTUAL,2021-09-13,2021-07-19,ACTUAL,2021-07-19,,INTERVENTIONAL,NABUCCO,,Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy,Phase 1B Study to Assess Safety and Efficacy of Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy (NABUCCO),COMPLETED,,PHASE1,54.0,ACTUAL,The Netherlands Cancer Institute,,3.0,,,f,,,,t,f,f,,,t,,,,,,NO,,2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,OTHER,,,,,,,2021,1.0
NCT04722666,,2021-01-21,,,2024-04-19,2021-01-21,2021-01-25,ACTUAL,,,,,,,2024-04-19,2024-04-22,ACTUAL,2021-07-20,ACTUAL,2021-07-20,2023-10,2023-10-31,2023-09-26,ACTUAL,2023-09-26,2023-09-26,ACTUAL,2023-09-26,,INTERVENTIONAL,,,Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent,"A Double-blind, Placebo-controlled, Randomized Dose-ranging Trial to Investigate Efficacy and Safety of Intravenous MIJ821 Infusion in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent",TERMINATED,,PHASE2,200.0,ACTUAL,Novartis,,7.0,,Terminated by Novartis,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/",2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,INDUSTRY,,,,,,,2023,0.0
NCT03502577,,2018-04-11,,,2024-01-04,2018-04-11,2018-04-18,ACTUAL,,,,,,,2024-01-04,2024-01-08,ACTUAL,2018-05-23,ACTUAL,2018-05-23,2023-12,2023-12-31,2022-04-20,ACTUAL,2022-04-20,2022-04-20,ACTUAL,2022-04-20,,INTERVENTIONAL,,,BCMA-Specific CAR T-Cells Combined With a Gamma Secretase Inhibitor (JSMD194) to Treat Relapsed or Persistent Multiple Myeloma,"A Phase I Study of B-Cell Maturation Antigen (BCMA)-Specific Chimeric Antigen Receptor T Cells in Combination With JSMD194, a Small Molecule Inhibitor of Gamma Secretase, in Patients With Relapsed or Persistent Multiple Myeloma",TERMINATED,,PHASE1,19.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,Closed per SRC Low Accrual Policy,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,OTHER,,,,,,,2022,0.0
NCT01788280,,2013-02-07,,,2018-02-05,2013-02-07,2013-02-11,ESTIMATED,,,,,,,2018-02-05,2018-02-07,ACTUAL,2018-01,ESTIMATED,2018-01-31,2018-02,2018-02-28,2022-01,ESTIMATED,2022-01-31,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,,,Preliminary Assessment of [18F] Fluciclatide (GE [18F]AH111585) in Glioblastoma Multiforme Treated With Bevacizumab,Preliminary Assessment of [18F] Fluciclatide (GE [18F]AH111585) in Glioblastoma Multiforme Treated With Bevacizumab,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Utah,,1.0,,"Unable to get materials from GE, study not proceeding and never opened to accrual",f,,,,t,t,f,,,,,,,,,,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,OTHER,,,,,,,2022,0.0
NCT04442490,,2020-06-18,2023-08-25,2022-03-25,2023-12-20,2020-06-18,2020-06-22,ACTUAL,2023-11-13,2023-12-05,ACTUAL,,2023-12-05,ACTUAL,2023-12-20,2023-12-22,ACTUAL,2020-05-12,ACTUAL,2020-05-12,2023-12,2023-12-31,2021-04-21,ACTUAL,2021-04-21,2021-03-26,ACTUAL,2021-03-26,,INTERVENTIONAL,,Safety Set included all participants who were administered IP.,A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD),"A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of SAGE-217 in the Treatment of Adult Subjects With Major Depressive Disorder",COMPLETED,,PHASE3,543.0,ACTUAL,Biogen,,2.0,,,f,,,,f,t,f,,,f,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,INDUSTRY,,,,,,,2021,1.0
NCT02067741,,2014-02-11,,,2023-06-26,2014-02-17,2014-02-20,ESTIMATED,,,,,,,2023-06-26,2023-06-27,ACTUAL,2016-06-14,ACTUAL,2016-06-14,2023-01,2023-01-31,2022-10-24,ACTUAL,2022-10-24,2018-08-02,ACTUAL,2018-08-02,,INTERVENTIONAL,,,CR1447 in Endocrine Responsive-HER2neg and TN-ARpos Breast Cancer,"A Stratified, Multicenter Phase II Trial of Transdermal CR1447 (4-OH-testosterone) in Endocrine Responsive-HER2 Negative and Triple Negative-androgen Receptor Positive Metastatic or Locally Advanced Breast Cancer",TERMINATED,,PHASE2,29.0,ACTUAL,Swiss Group for Clinical Cancer Research,,2.0,,"The SAKK board decided to prematurely end the life-long follow-up of the trial SAKK 21/12, as 90% of the patients have died.",f,,,,f,,,,,,,,,,,NO,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,OTHER,,,,,,,2022,0.0
NCT03220009,,2017-07-17,,,2018-10-02,2017-07-17,2017-07-18,ACTUAL,,,,,,,2018-10-02,2018-10-03,ACTUAL,2017-11-03,ACTUAL,2017-11-03,2018-10,2018-10-31,2021-07-01,ESTIMATED,2021-07-01,2021-07-01,ESTIMATED,2021-07-01,,INTERVENTIONAL,,,"Nivolumab or Expectant Observation Following Ipilimumab, Nivolumab, and Surgery in Treating Patients With High Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma","A Randomized Phase II Trial of Adjuvant Nivolumab or Expectant Observation Following Neoadjuvant Ipilimumab Plus Nivolumab and Surgical Resection of High-Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma",WITHDRAWN,,PHASE2,0.0,ACTUAL,National Cancer Institute (NCI),,2.0,,The study was never approved by CTEP neither was it ever activated,f,,,,f,t,f,,,,,,,,,,,2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,NIH,,,,,,,2021,0.0
NCT03035630,,2017-01-24,,,2022-02-14,2017-01-25,2017-01-30,ESTIMATED,,,,,,,2022-02-14,2022-02-15,ACTUAL,2017-05-23,ACTUAL,2017-05-23,2022-02,2022-02-28,2020-12,ESTIMATED,2020-12-31,2018-12,ESTIMATED,2018-12-31,,INTERVENTIONAL,,,Sunitinib Followed by Avelumab or the Reverse for Metastatic Renal Cell Carcinoma,Randomized Phase II Trial Comparing Sequential First-line Sunitinib and Second-line Avelumab vs First-line Avelumab and Second-line Sunitinib for Metastatic Renal Cell Carcinoma: SUAVE Trial. Hoosier Cancer Research Network GU15-223,WITHDRAWN,,PHASE2,0.0,ACTUAL,Hoosier Cancer Research Network,,2.0,,Principal investigator left lead institution and efforts to open the protocol at another institution were not successful.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,OTHER,,,,,,,2020,0.0
NCT04193202,,2019-12-09,2022-09-19,,2023-05-11,2019-12-09,2019-12-10,ACTUAL,2022-09-19,2022-10-14,ACTUAL,,,,2023-05-11,2023-05-16,ACTUAL,2020-05-21,ACTUAL,2020-05-21,2023-05,2023-05-31,2021-11-03,ACTUAL,2021-11-03,2021-10-19,ACTUAL,2021-10-19,,INTERVENTIONAL,,,Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043),"A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Adult Participants With Recent Onset Chronic Cough",COMPLETED,,PHASE3,419.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,INDUSTRY,,,,,,,2021,1.0
NCT03693573,,2018-09-25,,,2018-11-13,2018-10-01,2018-10-03,ACTUAL,,,,,,,2018-11-13,2018-11-15,ACTUAL,2019-01-11,ESTIMATED,2019-01-11,2018-11,2018-11-30,2024-01-31,ESTIMATED,2024-01-31,2021-08-14,ESTIMATED,2021-08-14,,INTERVENTIONAL,,,A Study of Atezolizumab in Combination With Bevacizumab in Untreated Locally Advanced or Metastatic Clear Cell or Non-Clear Cell Renal Cell Carcinoma,"An Open Label, Phase IIIB, Single Arm, Multicenter Safety Study of Atezolizumab in Combination With Bevacizumab in Untreated Locally Advanced or Metastatic Clear Cell or Non-Clear Cell Renal Cell Carcinoma",WITHDRAWN,,PHASE3,0.0,ACTUAL,Hoffmann-La Roche,,1.0,,"In the context of the ongoing evaluation of our data, we have determined that there is no need to generate additional safety data at this time in the 1L mRCC pa",f,,,,t,t,f,,,t,,,,,,,,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,INDUSTRY,,,,,,,2024,0.0
NCT03283670,,2016-11-09,2021-02-09,,2022-03-28,2017-09-13,2017-09-14,ACTUAL,2022-03-28,2022-04-04,ACTUAL,,,,2022-03-28,2022-04-04,ACTUAL,2016-11-22,ACTUAL,2016-11-22,2022-03,2022-03-31,2020-02-18,ACTUAL,2020-02-18,2020-02-18,ACTUAL,2020-02-18,,INTERVENTIONAL,NARSAD,,Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies,Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies,COMPLETED,,PHASE2,24.0,ACTUAL,Washington University School of Medicine,,3.0,,,f,,,,f,,,,,,,,,,,NO,There is no plan to share IPD.,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,OTHER,,,,,,,2020,1.0
NCT03061812,,2017-02-20,2021-01-29,,2021-02-19,2017-02-20,2017-02-23,ACTUAL,2021-02-19,2021-02-23,ACTUAL,,,,2021-02-19,2021-02-23,ACTUAL,2017-04-11,ACTUAL,2017-04-11,2021-02,2021-02-28,2020-02-12,ACTUAL,2020-02-12,2020-02-12,ACTUAL,2020-02-12,,INTERVENTIONAL,TAHOE,,Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE),"A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for Subjects With Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) Who Have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy (TAHOE)",COMPLETED,,PHASE3,444.0,ACTUAL,AbbVie,,2.0,,,t,,,,t,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,INDUSTRY,,NCT03503890,NO_LONGER_AVAILABLE,,,,2020,1.0
NCT04946162,,2021-06-28,,,2021-06-30,2021-06-28,2021-06-30,ACTUAL,,,,,,,2021-06-30,2021-07-02,ACTUAL,2020-04-20,ACTUAL,2020-04-20,2021-06,2021-06-30,2020-04-20,ACTUAL,2020-04-20,2020-04-20,ACTUAL,2020-04-20,,INTERVENTIONAL,,,The Use of Tadalafil in Confirmed COVID-19 Pneumonia.,The Use of Tadalafil in Confirmed COVID-19 Pneumonia.,WITHDRAWN,,PHASE4,0.0,ACTUAL,Santa Barbara Cottage Hospital,,1.0,,The investigators never completed the IRB application due to decrease in need to conduct the study.,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,OTHER,,,,,,,2020,0.0
NCT01709981,,2012-10-16,2020-07-23,,2022-05-03,2012-10-17,2012-10-18,ESTIMATED,2020-08-26,2020-09-09,ACTUAL,,,,2022-05-03,2022-05-25,ACTUAL,2013-05-30,ACTUAL,2013-05-30,2022-05,2022-05-31,2021-12-13,ACTUAL,2021-12-13,2019-08-30,ACTUAL,2019-08-30,,INTERVENTIONAL,,,Anti-inflammatory Effects of Colchicine in PCI,Anti-inflammatory Effects of Colchicine in Patients Undergoing Percutaneous Coronary Intervention: Inflammatory Marker Substudy of the Colchicine-PCI Trial,COMPLETED,,PHASE4,280.0,ACTUAL,NYU Langone Health,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,OTHER,,,,,,,2021,1.0
NCT03416816,,2018-01-18,,,2023-11-13,2018-01-24,2018-01-31,ACTUAL,,,,,,,2023-11-13,2023-11-14,ACTUAL,2018-05-15,ACTUAL,2018-05-15,2023-11,2023-11-30,2020-06-15,ACTUAL,2020-06-15,2020-06-15,ACTUAL,2020-06-15,,INTERVENTIONAL,,,A Study of DSP-0337 in Patients With Advanced Solid Tumors to Determine the Safety and the Pharmacokinetic Profile,A First-in-Human Phase I Trial to Determine the Safety and the Pharmacokinetic Profile of DSP-0337 in Patients With Advanced Solid Tumors,TERMINATED,,PHASE1,23.0,ACTUAL,"Sumitomo Pharma America, Inc.",,1.0,,Alternate development strategy,f,,,,f,t,f,,,,,,,,,,,2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,INDUSTRY,,,,,,,2020,0.0
NCT04260191,,2020-02-05,2023-04-24,,2023-04-24,2020-02-05,2020-02-07,ACTUAL,2023-04-24,2024-01-25,ACTUAL,,,,2023-04-24,2024-01-25,ACTUAL,2020-06-29,ACTUAL,2020-06-29,2023-04,2023-04-30,2022-06-02,ACTUAL,2022-06-02,2022-06-02,ACTUAL,2022-06-02,,INTERVENTIONAL,,Safety Analysis Set: All participants that were enrolled and received at least 1 dose of AMG 910.,Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma,"A Global Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of the Half-life Extended Bispecific T-cell Engager AMG 910 in Subjects With Claudin 18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma",TERMINATED,,PHASE1,15.0,ACTUAL,Amgen,The study was discontinued due to a strategic decision to end clinical development for AMG 910 that was unrelated to safety.,3.0,,Business Decision,,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,INDUSTRY,,,,,,,2022,0.0
NCT06045624,,2023-09-13,,,2024-04-03,2023-09-13,2023-09-21,ACTUAL,,,,,,,2024-04-03,2024-04-05,ACTUAL,2023-10-17,ESTIMATED,2023-10-17,2024-04,2024-04-30,2024-02-06,ACTUAL,2024-02-06,2024-02-06,ACTUAL,2024-02-06,,INTERVENTIONAL,,,A First in Human Single and Multiple Ascending Dose and Open Label Food Effect Study of OR-101 in Healthy Subjects,"A Phase 1, First in Human, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose and Open Label Food Effect Study to Evaluate Safety, Tolerability, and Pharmacokinetics of OR-101 Administered Orally in Healthy Subjects",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Ornovi, Inc.",,4.0,,The study was cancelled as the sponsor decided to reformulate the IP,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,INDUSTRY,,,,,,,2024,0.0
NCT02898753,,2016-09-08,,,2020-05-29,2016-09-08,2016-09-13,ESTIMATED,,,,,,,2020-05-29,2020-06-02,ACTUAL,2017-06-21,ACTUAL,2017-06-21,2020-05,2020-05-31,2020-03-25,ACTUAL,2020-03-25,2020-03-25,ACTUAL,2020-03-25,,INTERVENTIONAL,,,VAL-1221 Delivered Intravenously in Ambulatory and Ventilator-free Participants With Late-Onset Pompe Disease,"A Three-Month, Open-Label, Randomized, Dose-escalation Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of VAL-1221 Versus Myozyme®/Lumizyme® in Patients With Late-Onset GSD-II (Pompe Disease) Followed by Open-Label Treatment With VAL-1221 in All Patients",TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,"Valerion Therapeutics, LLC",,4.0,,Company closure due to lack of funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,INDUSTRY,,,,,,,2020,0.0
NCT03865953,,2019-03-02,2021-03-03,,2021-05-20,2019-03-06,2019-03-07,ACTUAL,2021-04-20,2021-04-23,ACTUAL,,,,2021-05-20,2021-06-14,ACTUAL,2019-04-09,ACTUAL,2019-04-09,2021-04,2021-04-30,2020-05-03,ACTUAL,2020-05-03,2020-04-19,ACTUAL,2020-04-19,,INTERVENTIONAL,,,Oral LAT8881 in Neuropathic Pain,A Phase IIa Study of the Efficacy and Safety of Oral LAT8881 in Neuropathic Pain,COMPLETED,,PHASE2,53.0,ACTUAL,Lateral Pharma Pty Ltd,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,This is an Early Proof of Concept study,2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,INDUSTRY,,,,,,,2020,1.0
NCT04203017,,2019-10-30,,,2023-11-29,2019-12-15,2019-12-18,ACTUAL,,,,,,,2023-11-29,2023-12-06,ACTUAL,2019-06-01,ACTUAL,2019-06-01,2023-11,2023-11-30,2023-11-29,ACTUAL,2023-11-29,2023-11-29,ACTUAL,2023-11-29,,INTERVENTIONAL,,,Fecal Microbiota Transplantation After Autologous HSCT in Patients With Multiple Sclerosis,Allogeneic Fecal Microbiota Transplantation as a Consolidation Treatment After Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Sclerosis,TERMINATED,,PHASE1,20.0,ACTUAL,St. Petersburg State Pavlov Medical University,,1.0,,the bio-samples are corrupted for technical reasons,f,,,,f,f,f,,,,,,,,,,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,OTHER,,,,,,,2023,0.0
NCT04919863,,2021-05-20,,,2022-02-23,2021-06-03,2021-06-09,ACTUAL,,,,,,,2022-02-23,2022-02-24,ACTUAL,2021-05-24,ACTUAL,2021-05-24,2022-02,2022-02-28,2022-01-20,ACTUAL,2022-01-20,2022-01-20,ACTUAL,2022-01-20,,INTERVENTIONAL,,,"Safety, Tolerability and Pharmacokinetics of NTP42:KVA4","A Phase I Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of NTP42:KVA4 in Healthy Volunteers",COMPLETED,,PHASE1,79.0,ACTUAL,ATXA Therapeutics Limited,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,INDUSTRY,,,,,,,2022,1.0
NCT02471144,,2015-05-04,2021-06-24,2019-08-20,2023-09-29,2015-06-10,2015-06-15,ESTIMATED,2021-07-22,2021-08-16,ACTUAL,2019-08-20,2019-08-28,ACTUAL,2023-09-29,2023-10-11,ACTUAL,2015-09-29,ACTUAL,2015-09-29,2023-09,2023-09-30,2023-03-30,ACTUAL,2023-03-30,2018-12-13,ACTUAL,2018-12-13,,INTERVENTIONAL,,"The randomized set was defined as all patients who were randomized. Mis-randomized patients were excluded from the randomized set. If patients were re screened and successfully randomized, they were included in the randomized set according to the treatment assigned in the last randomization.",Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis,"A Randomized, Double-blind, Placebo- and Active Controlled Multicenter Trial to Demonstrate Efficacy of Subcutaneous Secukinumab Compared to Placebo and Etanercept (in a Single-blinded Arm) After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, and Long-term Efficacy in Subjects From 6 to Less Than 18 Years of Age With Severe Chronic Plaque Psoriasis",COMPLETED,,PHASE3,162.0,ACTUAL,Novartis,,4.0,,,f,,,,t,t,f,,,f,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,INDUSTRY,,,,,,,2023,1.0
NCT02910843,,2016-09-14,,,2023-01-09,2016-09-20,2016-09-22,ESTIMATED,,,,,,,2023-01-09,2023-01-10,ACTUAL,2017-02-22,ACTUAL,2017-02-22,2023-01,2023-01-31,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,RECAP,,Neoadjuvant Treatment With Regorafenib and Capecitabine Combined With Radiotherapy in Locally Advanced Rectal Cancer,Neoadjuvant Treatment With Regorafenib and Capecitabine Combined With Radiotherapy in Locally Advanced Rectal Cancer. A Multicenter Phase Ib Trial (RECAP),TERMINATED,,PHASE1,25.0,ACTUAL,Swiss Group for Clinical Cancer Research,,1.0,,due to structural financial deficit of SAKK,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,OTHER,,,,,,,2021,0.0
NCT03535675,,2018-05-10,2023-04-03,,2023-05-18,2018-05-22,2018-05-24,ACTUAL,2023-05-18,2023-05-22,ACTUAL,,,,2023-05-18,2023-05-22,ACTUAL,2018-10-30,ACTUAL,2018-10-30,2023-04,2023-04-30,2022-11-03,ACTUAL,2022-11-03,2022-07-06,ACTUAL,2022-07-06,,INTERVENTIONAL,,,Muscadine Plus (MPX) In Men With Prostate Cancer,"A Randomized Double-Blind, Placebo-Controlled Study Of The Effects Of MPX Capsules On Rising Prostate-Specific Antigen Levels In Alanine/Alanine SOD2 Genotype Men Following Initial Therapy For Prostate Cancer",TERMINATED,,PHASE3,59.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,2.0,,The study was terminated by DSMB due to futility.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,OTHER,,,,,,,2022,0.0
NCT03380026,,2017-12-12,2021-09-03,,2021-10-27,2017-12-15,2017-12-20,ACTUAL,2021-10-27,2021-11-24,ACTUAL,,,,2021-10-27,2021-11-24,ACTUAL,2017-12-13,ACTUAL,2017-12-13,2021-10,2021-10-31,2020-12-13,ACTUAL,2020-12-13,2020-08-03,ACTUAL,2020-08-03,,INTERVENTIONAL,MIDAS,,Mechlorethamine Induced Contact Dermatitis Avoidance Study,Valchlor Therapy in Conjunction With Triamcinolone 0.1% Ointment for the Treatment of Contact Dermatitis in Patients With Early Stage Cutaneous T-cell Lymphoma (Mechlorethamine Induced Dermatitis Avoidance Study),COMPLETED,,PHASE2,28.0,ACTUAL,"Rochester Skin Lymphoma Medical Group, PLLC",,2.0,,,f,,,,f,t,f,,,,,,Expected embargo would be one year from study completion. De-identified data will be maintained at the study site for 2 years after the study ends. Contact addresses and phone numbers will be presented on all publications to assist in this study sharing.,Data will be shared with investigators whose proposed use of data has been approved by an independent institutional review board.,,YES,"Data will be embargoed until the study site has fully examined it. Expected embargo would be one year from study completion.~Study data that is de-identified will be maintained at the study site. As this field is rapidly changing, if a database is available for safe, public upload at the end of study embargo, it will be uploaded to a national database. Otherwise requests for use of the study data will be accepted at the study site and shared with investigators whose proposed use of data has been approved by an independent institutional review board. Contact addresses and phone numbers will be presented on all publications to assist in this study sharing.",2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,OTHER,,,,,,,2020,1.0
NCT03055234,,2017-01-27,,,2017-04-07,2017-02-13,2017-02-16,ACTUAL,,,,,,,2017-04-07,2017-04-11,ACTUAL,2017-06,ESTIMATED,2017-06-30,2017-04,2017-04-30,2022-12,ESTIMATED,2022-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Study to Evaluate Efficacy and Safety of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Sickle Cell Disease (SCD),"A Phase 3, Multicenter, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Sickle Cell Disease",WITHDRAWN,,PHASE3,0.0,ACTUAL,United Therapeutics,,2.0,,Business decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,INDUSTRY,,,,,,,2022,0.0
NCT03919175,,2019-04-15,,,2024-05-06,2019-04-17,2019-04-18,ACTUAL,,,,,,,2024-05-06,2024-05-08,ACTUAL,2019-09-01,ACTUAL,2019-09-01,2024-05,2024-05-31,2024-05-05,ACTUAL,2024-05-05,2024-05-05,ACTUAL,2024-05-05,,INTERVENTIONAL,,,Umbralisib and Rituximab as Initial Therapy for Patients With Follicular Lymphoma and Marginal Zone Lymphoma,A Phase 2 Study of Umbralisib and Rituximab as Initial Therapy for Patients With Follicular Lymphoma and Marginal Zone Lymphoma,TERMINATED,,PHASE2,18.0,ACTUAL,Massachusetts General Hospital,,1.0,,Umbralisib development terminated; closed to accrual 8/29/2022,f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,OTHER,,,,,,,2024,0.0
NCT02979093,,2016-11-17,,2022-01-11,2022-11-25,2016-11-28,2016-12-01,ESTIMATED,,,,,,,2022-11-25,2022-11-29,ACTUAL,2017-05-05,ACTUAL,2017-05-05,2022-11,2022-11-30,2021-05-17,ACTUAL,2021-05-17,2021-05-17,ACTUAL,2021-05-17,,INTERVENTIONAL,,,Oxytocin and Brain Responses in Maternal Addiction,Oxytocin and Brain Reward and Stress Responses to Infant Cues in Addicted Mothers,TERMINATED,,PHASE2,73.0,ACTUAL,University of Iowa,,2.0,,Unable to recruit proposed study sample size due to COVID restrictions.,f,,,,t,t,f,,,,,,,,,NO,The University of Iowa and Yale will compile data from both sites for data analysis purposes only. There is no plan to make individual participant data available.,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,OTHER,,,,,,,2021,0.0
NCT02899728,,2016-09-13,2021-03-22,,2023-09-22,2016-09-13,2016-09-14,ESTIMATED,2021-03-22,2021-04-19,ACTUAL,,,,2023-09-22,2023-10-17,ACTUAL,2018-03-30,ACTUAL,2018-03-30,2023-09,2023-09-30,2020-03-17,ACTUAL,2020-03-17,2020-03-17,ACTUAL,2020-03-17,,INTERVENTIONAL,,,"Olaparib, Cediranib Maleate, and Standard Chemotherapy in Treating Patients With Small Cell Lung Cancer",A Phase II Study of Olaparib Plus Cediranib in Combination With Standard Therapy for Small Cell Lung Cancer,TERMINATED,,PHASE2,9.0,ACTUAL,National Cancer Institute (NCI),,2.0,,Inadequate accrual rate,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,NIH,,,,,,,2020,0.0
NCT02885649,,2016-08-26,,,2021-09-14,2016-08-26,2016-08-31,ESTIMATED,,,,,,,2021-09-14,2021-09-16,ACTUAL,2017-12-05,ACTUAL,2017-12-05,2021-09,2021-09-30,2020-03-02,ACTUAL,2020-03-02,2020-03-02,ACTUAL,2020-03-02,,INTERVENTIONAL,,,Enzalutamide Before Surgery in Treating Patients With Kidney Cancer,Pilot Study of the Blockade of Androgens in Renal Cell Carcinoma Using Enzalutamide (BARE),TERMINATED,,EARLY_PHASE1,3.0,ACTUAL,"Rutgers, The State University of New Jersey",,1.0,,Funding unavailable,,,,,t,t,f,,,,,,,,,,,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,OTHER,,,,,,,2020,0.0
NCT04147195,,2019-10-22,2022-11-17,,2023-08-16,2019-10-29,2019-11-01,ACTUAL,2023-01-10,2023-01-26,ACTUAL,,,,2023-08-16,2023-08-21,ACTUAL,2020-06-04,ACTUAL,2020-06-04,2023-08,2023-08-31,2022-01-06,ACTUAL,2022-01-06,2022-01-06,ACTUAL,2022-01-06,,INTERVENTIONAL,NEXSCOT,,Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH),"NASH EXploratory Single and COmbination Treatment (NEXSCOT): An Open Label, Multicenter, Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Various Single and Combination Treatments in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) Who Manifest a Non-alcoholic Steatohepatitis (NASH)-Like Biomarker Phenotype",TERMINATED,,PHASE2,41.0,ACTUAL,Novartis,,2.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,INDUSTRY,,,,,,,2022,0.0
NCT03438396,,2018-02-08,2021-10-06,2021-02-01,2023-07-11,2018-02-16,2018-02-19,ACTUAL,2021-10-06,2021-11-04,ACTUAL,2021-02-01,2021-02-03,ACTUAL,2023-07-11,2023-07-25,ACTUAL,2018-06-12,ACTUAL,2018-06-12,2023-07,2023-07-31,2022-08-02,ACTUAL,2022-08-02,2020-02-06,ACTUAL,2020-02-06,,INTERVENTIONAL,,Full analysis set (FAS) included all participants who received at least 1 dose of tisotumab vedotin.,A Trial of Tisotumab Vedotin in Cervical Cancer,"A Single Arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer",COMPLETED,,PHASE2,102.0,ACTUAL,Seagen Inc.,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,INDUSTRY,,,,,,,2022,1.0
NCT04397445,,2020-05-15,2021-06-28,,2021-08-05,2020-05-20,2020-05-21,ACTUAL,2021-06-28,2021-07-19,ACTUAL,,,,2021-08-05,2021-08-09,ACTUAL,2020-06-08,ACTUAL,2020-06-08,2021-08,2021-08-31,2020-07-01,ACTUAL,2020-07-01,2020-07-01,ACTUAL,2020-07-01,,INTERVENTIONAL,,,Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration,Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration,COMPLETED,,PHASE1,18.0,ACTUAL,Food and Drug Administration (FDA),,4.0,,,f,,,,f,t,f,,,f,,,,,,YES,"Plan is to make data from the study publicly available as part of a manuscript publication. In addition, the protocol and statistical analysis plan will be made available online at this site as well as with any eventual publications.",2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,FED,,,,,,,2020,1.0
NCT05026801,,2021-02-08,,,2021-10-26,2021-08-26,2021-08-30,ACTUAL,,,,,,,2021-10-26,2021-10-28,ACTUAL,2021-02-08,ACTUAL,2021-02-08,2021-10,2021-10-31,2021-08-26,ACTUAL,2021-08-26,2021-08-26,ACTUAL,2021-08-26,,INTERVENTIONAL,,,Azithromycin Plus Hydroxychloroquine for COVID-19 Infection,"A Randomized, Double-blinded Phase 3 Multi-center Study of the Clinical and Microbiologic Efficacy of a Combination of Azithromycin and Hydroxychloroquine for Treatment of COVID-19 Infection",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Iterum Therapeutics, International Limited",,2.0,,Inadequate support to carry out study,f,,,,t,t,f,,,,,,Data will be available within 30 days of study completion.,Data access requests will be reviewed on a case by case basis. Requestors will be required to sign a Data Access Agreement.,http://www.iterumtx.com,YES,Deidentified individual participant data for all primary and secondary outcome measures will be made available.,2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,INDUSTRY,,,,,,,2021,0.0
NCT04393311,,2020-05-15,,,2022-02-15,2020-05-15,2020-05-19,ACTUAL,,,,,,,2022-02-15,2022-03-03,ACTUAL,2022-02,ESTIMATED,2022-02-28,2022-02,2022-02-28,2022-08,ESTIMATED,2022-08-31,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,,,Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients,"A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety and Efficacy of Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Stanford University,,2.0,,Discontinuation of drug candidates,f,,,,t,t,f,,,,,,,,,NO,No plan to share data.,2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,OTHER,,,,,,,2022,0.0
NCT04638309,,2020-11-13,,,2022-07-20,2020-11-16,2020-11-20,ACTUAL,,,,,,,2022-07-20,2022-07-22,ACTUAL,2021-09-20,ACTUAL,2021-09-20,2022-07,2022-07-31,2022-04-25,ACTUAL,2022-04-25,2022-04-25,ACTUAL,2022-04-25,,INTERVENTIONAL,,,APR-548 in Combination With Azacitidine for the Treatment of TP53 Myelodysplastic Syndromes (MDS),Phase 1 Study to Evaluate Safety and Efficacy of APR-548 in Combination With Azacitidine for the Treatment of TP53-Mutant Myelodysplastic Syndromes,TERMINATED,,PHASE1,4.0,ACTUAL,Aprea Therapeutics,,3.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,INDUSTRY,,,,,,,2022,0.0
NCT03343613,,2017-11-09,,,2020-06-08,2017-11-10,2017-11-17,ACTUAL,,,,,,,2020-06-08,2020-06-09,ACTUAL,2017-11-17,ACTUAL,2017-11-17,2020-06,2020-06-30,2020-05-04,ACTUAL,2020-05-04,2020-02-07,ACTUAL,2020-02-07,,INTERVENTIONAL,,,A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors,A Phase 1a/1b Study of an Anti-IDO-1 Agent (LY3381916) Administered Alone or in Combination With Anti- PD-L1 Checkpoint Antibody (LY3300054) in Solid Tumors,TERMINATED,,PHASE1,60.0,ACTUAL,Eli Lilly and Company,,6.0,,Study terminated due to strategic business decision by Eli Lilly and Company.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,INDUSTRY,,,,,,,2020,0.0
NCT05223673,,2022-01-25,2024-01-16,,2024-07-24,2022-01-25,2022-02-04,ACTUAL,2024-02-08,2024-03-05,ACTUAL,,,,2024-07-24,2024-08-20,ACTUAL,2022-04-21,ACTUAL,2022-04-21,2024-07,2024-07-31,2023-06-21,ACTUAL,2023-06-21,2023-06-21,ACTUAL,2023-06-21,,INTERVENTIONAL,COLSTAR,,Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer,"A Randomised, Open-label, Multi-centre, Two-arm Phase 3 Study Comparing Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil to Trifluridine/Tipiracil Single Agent With a Safety Lead-In Part in Participants With KRAS/NRAS and BRAF Wild Type Metastatic Colorectal Cancer Previously Treated With Standard Treatment and Anti-EGFR Therapy",TERMINATED,,PHASE3,7.0,ACTUAL,Servier,,2.0,,Sponsor decided to discontinue the study during the Lead-In part and the Phase III part was not started due to strategic reasons.,f,,,,t,t,f,,,f,,,After Marketing Authorisation in EEA or US if the study is used for the approval.,Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.,https://clinicaltrials.servier.com/,YES,"Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~sponsored by Servier with a first patient enrolled as of 1 January 2004 onwards for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.",2024-10-14 21:51:26.404456,2024-10-14 21:51:26.404456,INDUSTRY,,,,,,,2023,0.0
NCT05228821,,2022-01-10,,,2024-08-07,2022-01-27,2022-02-08,ACTUAL,,,,,,,2024-08-07,2024-08-09,ACTUAL,2023-08-09,ACTUAL,2023-08-09,2024-08,2024-08-31,2023-08-23,ACTUAL,2023-08-23,2023-08-23,ACTUAL,2023-08-23,,INTERVENTIONAL,,,Voxelotor Brain Oxygenation and Neurocognitive Study,"An Open Label, Single Arm, Multicenter Study to Evaluate the Effect of Voxelotor on Cerebral Blood Flow and Neurocognitive Function in Adolescents and Adults With Sickle Cell Disease",WITHDRAWN,,PHASE4,0.0,ACTUAL,Pfizer,,1.0,,The study has been stopped due to Sponsor's business reasons. The termination is not a result of any safety concerns or change in the benefit-risk ratio.,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,INDUSTRY,,,,,,,2023,0.0
NCT04915729,,2021-06-04,,,2023-12-11,2021-06-04,2021-06-07,ACTUAL,,,,,,,2023-12-11,2023-12-12,ACTUAL,2021-06-22,ACTUAL,2021-06-22,2023-12,2023-12-31,2023-10-08,ACTUAL,2023-10-08,2023-10-08,ACTUAL,2023-10-08,,INTERVENTIONAL,ORIGINAL,,A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity,"A Phase III Multi-centre, Prospective, Randomised, Open Label, Blinded Endpoint (PROBE), Active-controlled Parallel Group Trial to Assess Efficacy and Safety of Tenecteplase Versus Alteplase in Chinese Patients With Acute Ischaemic Stroke Within 4.5 Hours After Stroke Onset",COMPLETED,,PHASE3,1490.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,t,f,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,INDUSTRY,,,,,,,2023,1.0
NCT03127124,,2017-04-20,,,2024-04-01,2017-04-20,2017-04-25,ACTUAL,,,,,,,2024-04-01,2024-04-02,ACTUAL,2018-02-27,ACTUAL,2018-02-27,2020-06,2020-06-30,2023-12-06,ACTUAL,2023-12-06,2023-12-06,ACTUAL,2023-12-06,,INTERVENTIONAL,,,"QUILT-2.022 NANT-008 in Combination w/ 5-fluorouracil, Bevacizumab, Leucovorin & Oxaliplatin in Subjects With Pancreatic Cancer","An Open-label, Multicenter, Single-arm, Phase 1b/2 Study of NANT-008 in Combination With 5-fluorouracil, Bevacizumab, Leucovorin, and Oxaliplatin in Patients With Metastatic Pancreatic Adenocarcinoma.",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"NantPharma, LLC",,1.0,,This study was withdrawn due to no enrollment,,,,,f,t,f,,,,,,,,,NO,,2024-10-15 12:24:45.086124,2024-10-15 12:24:45.086124,INDUSTRY,,,,,,,2023,0.0
NCT03970837,,2019-05-16,2023-09-22,2022-08-05,2023-11-10,2019-05-29,2019-06-03,ACTUAL,2023-11-10,2023-11-30,ACTUAL,,2023-11-30,ACTUAL,2023-11-10,2023-11-30,ACTUAL,2019-06-05,ACTUAL,2019-06-05,2023-11,2023-11-30,2023-01-18,ACTUAL,2023-01-18,2021-10-29,ACTUAL,2021-10-29,,INTERVENTIONAL,contRAst 2,Intent-To-Treat (ITT) Population (All randomized participants who received at least 1 dose of study treatment) was used for Global cohort and ITT-Supplementary Asia Cohort (Participants randomized on or after 07-August-2021 who received at least one dose of study treatment) was used for Asia cohort. One participant from the GSK3196165 150mg + csDMARD (Asia Cohort) arm was randomized but not treated so is excluded from the ITT-Asia cohort population.,Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs),"A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDs",TERMINATED,,PHASE3,1764.0,ACTUAL,GlaxoSmithKline,,12.0,,Only Asia cohort is early terminated.Limited efficacy demonstrated in the contRAst program does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. GSK has decided not to progress with regulatory submissions.,f,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,INDUSTRY,,,,,,,2023,0.0
NCT04632992,,2020-11-12,,,2024-03-05,2020-11-12,2020-11-17,ACTUAL,,,,,,,2024-03-05,2024-03-07,ACTUAL,2021-01-13,ACTUAL,2021-01-13,2024-03,2024-03-31,2024-02-27,ACTUAL,2024-02-27,2023-12-04,ACTUAL,2023-12-04,,INTERVENTIONAL,MyTACTIC,,A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response,MyTACTIC: An Open-Label Phase II Study Evaluating Targeted Therapies in Patients Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response,COMPLETED,,PHASE2,252.0,ACTUAL,"Genentech, Inc.",,15.0,,,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).~For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).",2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,INDUSTRY,,,,,,,2024,1.0
NCT04650698,,2020-11-25,2024-02-01,,2024-03-08,2020-11-25,2020-12-03,ACTUAL,2024-03-08,2024-03-12,ACTUAL,,,,2024-03-08,2024-03-12,ACTUAL,2021-01-07,ACTUAL,2021-01-07,2024-03,2024-03-31,2023-03-12,ACTUAL,2023-03-12,2023-03-12,ACTUAL,2023-03-12,,INTERVENTIONAL,,,TXA in Revision Total Shoulder Arthroplasty,The Effect of Tranexamic Acid on Calculated Total Blood Loss in Patients Undergoing Revision Shoulder Arthroplasty,TERMINATED,,PHASE4,19.0,ACTUAL,NYU Langone Health,,2.0,,Enrollment rate was slower than anticipated.,f,,,,t,t,f,,,t,,,Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.,"The investigator who proposed to use the data upon reasonable request. Requests should be directed to Uchenna.Umeh@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.",,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.",2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,OTHER,,,,,,,2023,0.0
NCT03752242,,2018-11-15,2023-01-09,,2023-08-25,2018-11-21,2018-11-23,ACTUAL,2023-08-25,2023-09-21,ACTUAL,,,,2023-08-25,2023-09-21,ACTUAL,2019-01-03,ACTUAL,2019-01-03,2023-08,2023-08-31,2020-08-31,ACTUAL,2020-08-31,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,,,Evaluation of Topical Application of BMX-010 in Subjects With Acne Vulgaris.,An Exploratory Trial to Evaluate the Clinical Effectiveness of a Topical Application of BMX-010 in Subjects With Acne Vulgaris.,TERMINATED,,PHASE2,2.0,ACTUAL,"BioMimetix JV, LLC","The clinical trial was stopped after enrollment of 2 subjects for re-formulation of investigational product. Therefore, due to the small sample size data is uninterpretable.",1.0,,Enrollment stopped for chemistry work on investigational product.,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,INDUSTRY,,,,,,,2020,0.0
NCT04964089,,2021-07-06,2024-04-09,,2024-06-20,2021-07-06,2021-07-15,ACTUAL,2024-04-09,2024-05-02,ACTUAL,,,,2024-06-20,2024-07-03,ACTUAL,2021-06-23,ACTUAL,2021-06-23,2024-06,2024-06-30,2023-04-06,ACTUAL,2023-04-06,2023-03-28,ACTUAL,2023-03-28,,INTERVENTIONAL,DAYLIGHT,All randomized subjects who received at least one active study treatment (KSI-301 or aflibercept),A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD),"A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)",COMPLETED,,PHASE3,557.0,ACTUAL,Kodiak Sciences Inc,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,INDUSTRY,,,,,,,2023,1.0
NCT04483479,,2020-07-20,2023-10-03,,2024-02-20,2020-07-22,2020-07-23,ACTUAL,2024-02-20,2024-03-19,ACTUAL,,,,2024-02-20,2024-03-19,ACTUAL,2020-07-30,ACTUAL,2020-07-30,2024-02,2024-02-29,2022-02-17,ACTUAL,2022-02-17,2022-02-17,ACTUAL,2022-02-17,,INTERVENTIONAL,Rollover,,Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety Roll-over Study (Rollover),"A Multicenter, Non-Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered ENT-01 in Improving Constipation and Neurologic Symptoms in Patients With Parkinson's Disease and Constipation Over a 14-week Period",TERMINATED,,PHASE2,27.0,ACTUAL,Enterin Inc.,Study was terminated early due to poor recruitment/retention due to the pandemic.,1.0,,Poor recruitment/retention due to the pandemic. Data was not analyzed due to early termination.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,INDUSTRY,,,,,,,2022,0.0
NCT04972253,,2021-07-15,,,2022-08-08,2021-07-15,2021-07-22,ACTUAL,,,,,,,2022-08-08,2022-08-10,ACTUAL,2021-12-23,ACTUAL,2021-12-23,2022-08,2022-08-31,2023-12,ESTIMATED,2023-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,(BLASST)-3,,Phase I BLASST-3 Trial,Biomarker-directed Neoadjuvant Therapy for Cisplatin-ineligible or Cisplatin-refusing Muscle-invasive Bladder Cancer: Phase I Bladder Cancer Signal Seeking Trial,WITHDRAWN,,PHASE1,0.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,Low Accrual,f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,OTHER,,,,,,,2023,0.0
NCT03760250,,2018-11-28,2020-09-12,,2020-11-16,2018-11-28,2018-11-30,ACTUAL,2020-11-16,2020-11-19,ACTUAL,,,,2020-11-16,2020-11-19,ACTUAL,2019-02-05,ACTUAL,2019-02-05,2020-11,2020-11-30,2020-09-01,ACTUAL,2020-09-01,2019-09-05,ACTUAL,2019-09-05,,INTERVENTIONAL,,,Imiquimod for Preventing Keloid Recurrence,"Open-label, Single-arm Pilot Study of the Effects of Topical 5% Imiquimod Cream on Preventing Keloid Recurrence After Surgical Keloidectomy",TERMINATED,,PHASE2,6.0,ACTUAL,University of Pennsylvania,,1.0,,Investigator decision,f,,,,,t,f,,,f,,,,,,,,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,OTHER,,,,,,,2020,0.0
NCT02164734,,2014-06-13,2022-11-15,,2023-08-25,2014-06-13,2014-06-17,ESTIMATED,2023-08-25,2023-09-21,ACTUAL,,,,2023-08-25,2023-09-21,ACTUAL,2014-06,,2014-06-30,2023-08,2023-08-31,2020-12-31,ACTUAL,2020-12-31,2020-05-20,ACTUAL,2020-05-20,,INTERVENTIONAL,,Intention-to-treat analysis,Surfactant Via Endotracheal Tube vs. Laryngeal Mask Airway (LMA) in Preterm Neonates With Respiratory Distress Syndrome,Efficacy of Rescue Surfactant Delivery Via Endotracheal Intubation (INSURE Technique) Versus Laryngeal Mask Airway (LMA) for Respiratory Distress Syndrome (RDS) in Preterm Neonates,TERMINATED,,PHASE4,93.0,ACTUAL,Albany Medical College,"The trial was terminated before the target enrollment numbers were reached, due to slow recruitment, which became impossible soon after the onset of the COVID-19 pandemic.",2.0,,Slow to impossible recruitment during COVID-19 pandemic,f,,,,t,,,,,,,,,,,,,2024-10-16 18:27:32.092375,2024-10-16 18:27:32.092375,OTHER,,,,,,,2020,0.0
NCT04461028,,2019-10-11,,,2024-03-07,2020-07-01,2020-07-08,ACTUAL,,,,,,,2024-03-07,2024-03-12,ACTUAL,2019-02-21,ACTUAL,2019-02-21,2024-03,2024-03-31,2022-06-27,ACTUAL,2022-06-27,2022-06-27,ACTUAL,2022-06-27,,INTERVENTIONAL,,,Liposomal Bupivacaine in Shoulder Arthroscopy,The Effect of Liposomal Bupivacaine on the Quality of Recovery in Patients Undergoing Shoulder Arthroscopy,WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Pennsylvania,,2.0,,PI departed from the institution and study was closed.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,OTHER,,,,,,,2022,0.0
NCT02466243,,2015-06-02,2022-11-29,2019-01-18,2022-12-23,2015-06-04,2015-06-09,ESTIMATED,2022-12-23,2023-01-19,ACTUAL,2019-01-18,2019-01-22,ACTUAL,2022-12-23,2023-01-19,ACTUAL,2015-06,,2015-06-30,2022-12,2022-12-31,2021-01-29,ACTUAL,2021-01-29,2017-08,ACTUAL,2017-08-31,,INTERVENTIONAL,,"Numbers reflect all randomized subjects; all subjects were included in the safety, modified intent-to-treat, and per protocol populations","Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis","A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis",TERMINATED,,PHASE2,22.0,ACTUAL,Corbus Pharmaceuticals Inc.,,2.0,,Sponsor terminated open-label extension.,f,,,,f,,,,,,,,,,,,,2024-10-15 23:12:13.235142,2024-10-15 23:12:13.235142,INDUSTRY,,,,,,,2021,0.0
NCT04823845,,2021-03-05,,,2023-04-11,2021-03-28,2021-04-01,ACTUAL,,,,,,,2023-04-11,2023-04-13,ACTUAL,2022-05-01,ESTIMATED,2022-05-01,2023-04,2023-04-30,2023-02-10,ESTIMATED,2023-02-10,2022-12-10,ESTIMATED,2022-12-10,,INTERVENTIONAL,,,Plantar Wart Treatment Using Adapalene Gel,Plantar Wart Treatment Using Adapalene Gel,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Louisville,,1.0,,Study never received IRB approval.,f,,,,f,t,f,,,t,,,,,,NO,IPD will only be obtained/used by the researchers and no individual patient identifiers will be used.,2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,OTHER,,,,,,,2023,0.0
NCT02366143,,2015-02-12,2020-08-21,,2021-08-26,2015-02-12,2015-02-19,ESTIMATED,2020-10-05,2020-10-27,ACTUAL,,,,2021-08-26,2021-09-23,ACTUAL,2015-03-31,ACTUAL,2015-03-31,2021-08,2021-08-31,2020-12-07,ACTUAL,2020-12-07,2019-09-13,ACTUAL,2019-09-13,,INTERVENTIONAL,IMpower150,,A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC),"A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer",COMPLETED,,PHASE3,1202.0,ACTUAL,Hoffmann-La Roche,,3.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,INDUSTRY,,,,,,,2020,1.0
NCT03197025,,2017-06-22,2019-09-20,,2021-02-01,2017-06-22,2017-06-23,ACTUAL,2019-09-20,2019-10-08,ACTUAL,,,,2021-02-01,2021-02-16,ACTUAL,2018-01-09,ACTUAL,2018-01-09,2021-02,2021-02-28,2020-10-16,ACTUAL,2020-10-16,2019-05-14,ACTUAL,2019-05-14,,INTERVENTIONAL,,"One participant was enrolled, thus Arm/Group - 2/Arm 2 MTD was not done.",Immunotherapy With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions,A Phase I Study of Immunotherapy With E6 T Cell Receptor T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions,TERMINATED,,PHASE1,1.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,The study was closed due to investigator discretion based on the lack of perceived clinical activity observed in the study.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,NIH,,,,,,,2020,0.0
NCT01938001,,2013-09-05,2019-06-21,,2023-01-26,2013-09-09,2013-09-10,ESTIMATED,2019-07-19,2019-08-13,ACTUAL,,,,2023-01-26,2023-02-22,ACTUAL,2013-11-21,ACTUAL,2013-11-21,2023-01,2023-01-31,2022-01-26,ACTUAL,2022-01-26,2018-06-22,ACTUAL,2018-06-22,,INTERVENTIONAL,AUGMENT,"The intent to treat (ITT) population was defined as all participants who were randomized into the trial, regardless of whether they received investigational product (IP) or not.",Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma),"A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Placebo in Subjects With Relapsed/Refractory Indolent Lymphoma",COMPLETED,,PHASE3,358.0,ACTUAL,Celgene,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 09:04:53.068342,2024-10-16 09:04:53.068342,INDUSTRY,,,,,,,2022,1.0
NCT05124561,,2021-11-17,,,2023-06-14,2021-11-17,2021-11-18,ACTUAL,,,,,,,2023-06-14,2023-06-18,ACTUAL,2021-12-15,ESTIMATED,2021-12-15,2021-11,2021-11-30,2022-08-20,ESTIMATED,2022-08-20,2022-04-15,ESTIMATED,2022-04-15,,INTERVENTIONAL,,,Study to Evaluate the inHaled Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) On the Protective-Efficacy in Adults (SeiHOPE),"A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial on the Efficacy, Safety, and Immunogenicity of Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation (Ad5-nCoV-IH) in Adults Aged 18 Years and Above Who Have Received One Dose of Intramuscular Ad5-nCoV",WITHDRAWN,,PHASE3,0.0,ACTUAL,CanSino Biologics Inc.,,2.0,,The trial protocol was not approved by the regulatory authorities.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,INDUSTRY,,,,,,,2022,0.0
NCT04397796,,2020-05-18,2024-04-02,,2024-08-27,2020-05-19,2020-05-21,ACTUAL,2024-08-27,2024-09-05,ACTUAL,,,,2024-08-27,2024-09-05,ACTUAL,2020-08-03,ACTUAL,2020-08-03,2024-04,2024-04-30,2020-09-06,ACTUAL,2020-09-06,2020-09-06,ACTUAL,2020-09-06,,INTERVENTIONAL,,,Study of the Safety of Therapeutic Tx With Immunomodulatory MSC in Adults With COVID-19 Infection Requiring Mechanical Ventilation,"Phase 1b Randomized, Double-Blind, Placebo-Controlled Study Of The Safety Of Therapeutic Treatment With Immunomodulatory Mesenchymal Stem Cells In Adults With COVID-19 Infection Requiring Mechanical Ventilation",TERMINATED,,PHASE1,4.0,ACTUAL,"ImmunityBio, Inc.",The study is terminated early due to low enrollment. Efficacy of the Investigational Product is not analyzed.~Race was not collected in the CRFs for subjects and therefore is not presented in the data output for these subjects.~Treatment-Emergent Adverse Events Table includes Serious Adverse Events.,2.0,,Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,INDUSTRY,,,,,,,2020,0.0
NCT03911869,,2019-03-14,2023-01-05,,2023-05-30,2019-04-09,2019-04-11,ACTUAL,2023-05-30,2023-05-31,ACTUAL,,,,2023-05-30,2023-05-31,ACTUAL,2019-04-30,ACTUAL,2019-04-30,2023-05,2023-05-31,2022-01-27,ACTUAL,2022-01-27,2022-01-27,ACTUAL,2022-01-27,,INTERVENTIONAL,POLARIS,The safety set included all participants who received at least 1 dose of any study drug.,"An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis","A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain Metastasis",TERMINATED,,PHASE2,13.0,ACTUAL,Pfizer,Data for pharmacokinetic outcome measure for Phase 2 was not collected and analyzed as sampling was insufficient to support noncompartmental analysis in participants.,2.0,,"Study terminated due to lack of enrollment of the target population. There were no safety, efficacy, or regulatory interaction involved in the decision to stop enrollment.",f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,INDUSTRY,,,,,,,2022,0.0
NCT04129320,,2019-10-14,,,2022-02-04,2019-10-15,2019-10-16,ACTUAL,,,,,,,2022-02-04,2022-02-08,ACTUAL,2019-10,ESTIMATED,2019-10-31,2022-02,2022-02-28,2022-10,ESTIMATED,2022-10-31,2020-10,ESTIMATED,2020-10-31,,INTERVENTIONAL,,,Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck,A Phase 2/3 Open-Label Trial to Evaluate Enoblituzumab in Combination With MGA012 or MGD013 in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,MacroGenics,,2.0,,Change in study design,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,INDUSTRY,,,,,,,2022,0.0
NCT04406389,,2020-05-26,2023-08-24,,2023-08-24,2020-05-26,2020-05-28,ACTUAL,2023-08-24,2023-09-21,ACTUAL,,,,2023-08-24,2023-09-21,ACTUAL,2020-10-13,ACTUAL,2020-10-13,2023-08,2023-08-31,2022-04-21,ACTUAL,2022-04-21,2021-04-17,ACTUAL,2021-04-17,,INTERVENTIONAL,IMPACT,,Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial),InterMediate ProphylACtic Versus Therapeutic Dose Anticoagulation in Critically Ill Patients With COVID-19: A Prospective Randomized Study (The IMPACT Trial),TERMINATED,,PHASE4,14.0,ACTUAL,Weill Medical College of Cornell University,"The statistical analysis plan (and associated statistical power) was based on an expected sample size of 186 participants. As only 14 participants enrolled, this reduced sample size is not sufficient for the statistical analysis plan as written, and, therefore, only descriptive statistics are presented for the study.",2.0,,Low accrual,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,OTHER,,,,,,,2022,0.0
NCT04328012,,2020-03-27,,,2022-03-09,2020-03-27,2020-03-31,ACTUAL,,,,,,,2022-03-09,2022-03-24,ACTUAL,2020-04-06,ACTUAL,2020-04-06,2022-03,2022-03-31,2021-12-01,ACTUAL,2021-12-01,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,COVIDMED,,COVID MED Trial - Comparison Of Therapeutics for Hospitalized Patients Infected With COVID-19,Comparison Of Therapeutics for Hospitalized Patients Infected With SARS-CoV-2 In a Pragmatic aDaptive randoMizED Clinical Trial During the COVID-19 Pandemic (COVID MED Trial),TERMINATED,,PHASE2/PHASE3,15.0,ACTUAL,Bassett Healthcare,,2.0,,difficult enrollment,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,OTHER,,,,,,,2021,0.0
NCT03928314,,2019-04-19,,,2023-12-11,2019-04-23,2019-04-26,ACTUAL,,,,,,,2023-12-11,2023-12-15,ACTUAL,2019-05-02,ACTUAL,2019-05-02,2023-12,2023-12-31,2023-12-04,ACTUAL,2023-12-04,2022-09-22,ACTUAL,2022-09-22,,INTERVENTIONAL,,,Study of ORIC-101 in Combination With Anticancer Therapy,An Open-label Phase 1b Study of ORIC-101 in Combination With Anticancer Therapy in Patients With Advanced or Metastatic Solid Tumors,TERMINATED,,PHASE1,83.0,ACTUAL,ORIC Pharmaceuticals,,2.0,,IND Withdrawn,,,,,t,t,f,,,,,,,,,,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,INDUSTRY,,,,,,,2023,0.0
NCT03221257,,2017-07-12,2023-03-16,,2023-12-13,2017-07-14,2017-07-18,ACTUAL,2023-12-13,2023-12-15,ACTUAL,,,,2023-12-13,2023-12-15,ACTUAL,2017-11-28,ACTUAL,2017-11-28,2023-12,2023-12-31,2022-06-13,ACTUAL,2022-06-13,2022-03-23,ACTUAL,2022-03-23,,INTERVENTIONAL,SLSIII,Safety population includes all the randomized participants who received at least one dose of study medication.,Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate,Scleroderma Lung Study III (SLS III): Combining the Anti-fibrotic Effects of Pirfenidone (PFD) With Mycophenolate (MMF) for Treating Scleroderma-related Interstitial Lung Disease,COMPLETED,,PHASE2,51.0,ACTUAL,"University of California, Los Angeles","Only 51 (34%) of our planned recruitment goal of 150 were randomized. During the recruitment period MMF became a standard of care for treatment in early systemic sclerosis (SSc)-ILD, including the treatment of both lung and skin disease, thereby increasing the difficulty in recruiting treatment-naïve patients. Other barriers to recruitment included the Coronavirus Disease 2019 (COVID-19) epidemic and FDA approval of nintedanib as an alternative treatment during the initial phase of the trial.",2.0,,,f,,,,t,t,f,,,f,,,Sharing will be made available after completion of the clinical trial and reporting of the primary outcome.,Access criteria will be made available after 01/01/2018 through the study website noted below.,http://sclerodermalungstudy.org,YES,A bio-specimen repository will be created in which de-identified blood specimens will be made available to qualified researchers who submit meritorious applications for the access and use of such samples. Requests for specimens and correlative analyses related to other linked and de-identified clinical data will be overseen by the Study Executive and Steering Committees and/or any sub-committees that they may appoint for this process.,2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,OTHER,,,,,,,2022,1.0
NCT02719392,,2016-03-16,,,2022-04-14,2016-03-21,2016-03-25,ESTIMATED,,,,,,,2022-04-14,2022-04-21,ACTUAL,2017-08-09,ACTUAL,2017-08-09,2022-04,2022-04-30,2024-04,ESTIMATED,2024-04-30,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,A Pilot Study Investigating the Efficacy of Minocycline and N-Acetyl Cysteine for Bipolar Depression,A Pilot Study Investigating the Efficacy of Minocycline and N-Acetyl Cysteine for Bipolar Depression,SUSPENDED,,PHASE4,40.0,ESTIMATED,Massachusetts General Hospital,,4.0,,"Due to limited study staff and the COVID-19 pandemic, enrollment has been paused as staff hours for this project have been reduced and reallocated to other projects.",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,OTHER,,,,,,,2024,0.0
NCT03903718,,2019-03-22,,,2020-01-14,2019-04-03,2019-04-04,ACTUAL,,,,,,,2020-01-14,2020-01-18,ACTUAL,2020-04-03,ESTIMATED,2020-04-03,2020-01,2020-01-31,2020-10-09,ESTIMATED,2020-10-09,2020-10-09,ESTIMATED,2020-10-09,,INTERVENTIONAL,,,Evaluation of the Safety and Efficacy of a Monoclonal Antibody to Treat Influenza,A Phase 1/2a Clinical Study to Evaluate the Efficacy of MEDI8852 in the Treatment of Influenza in Adults Challenged With a Wild-Type Influenza Strain,WITHDRAWN,,PHASE2,0.0,ACTUAL,MedImmune LLC,,6.0,,Terminated due to delay in site enrollment timelines,f,,,,,t,f,,,,,,,,,,,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,INDUSTRY,,,,,,,2020,0.0
NCT04968912,,2021-07-09,,,2024-03-27,2021-07-09,2021-07-20,ACTUAL,,,,,,,2024-03-27,2024-03-28,ACTUAL,2021-09-21,ACTUAL,2021-09-21,2024-03,2024-03-31,2023-11-30,ACTUAL,2023-11-30,2023-10-23,ACTUAL,2023-10-23,,INTERVENTIONAL,,,A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS),"A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)",COMPLETED,,PHASE2,163.0,ACTUAL,"Janssen Research & Development, LLC",,3.0,,,t,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,INDUSTRY,,NCT05221619,TEMPORARILY_NOT_AVAILABLE,,,,2023,1.0
NCT04878614,,2021-05-04,,,2023-04-06,2021-05-04,2021-05-07,ACTUAL,,,,,,,2023-04-06,2023-04-10,ACTUAL,2021-05-05,ACTUAL,2021-05-05,2023-04,2023-04-30,2022-02-16,ACTUAL,2022-02-16,2022-02-16,ACTUAL,2022-02-16,,INTERVENTIONAL,,,Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding,Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding,TERMINATED,,PHASE4,3.0,ACTUAL,"University of California, Los Angeles",,2.0,,Sponsor terminated study low accrual numbers,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,OTHER,,,,,,,2022,0.0
NCT03575065,,2018-06-19,2022-03-28,,2022-03-28,2018-06-28,2018-07-02,ACTUAL,2022-03-28,2022-09-07,ACTUAL,,,,2022-03-28,2022-09-07,ACTUAL,2018-06-22,ACTUAL,2018-06-22,2022-03,2022-03-31,2021-04-14,ACTUAL,2021-04-14,2020-10-09,ACTUAL,2020-10-09,,INTERVENTIONAL,,Safety Analysis Set included all participants who received at least 1 dose of pamiparib (BGB-290),Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China,"An Open Label, Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China",COMPLETED,,PHASE2,88.0,ACTUAL,BeiGene,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,INDUSTRY,,,,,,,2021,1.0
NCT02996760,,2016-12-02,,,2022-03-29,2016-12-14,2016-12-19,ESTIMATED,,,,,,,2022-03-29,2022-04-07,ACTUAL,2018-03-14,ACTUAL,2018-03-14,2022-03,2022-03-31,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Influence Instillation Plasma Rich in Growth Factors in Endometrial Cavity Endometrial Development in Assisted Reproduction.,Influence Instillation Plasma Rich in Growth Factors in Endometrial Cavity,TERMINATED,,PHASE3,22.0,ACTUAL,IVI Bilbao,,2.0,,difficulty in recruiting,f,,,,t,f,f,,,,,,,,,,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,OTHER,,,,,,,2021,0.0
NCT04569084,,2020-09-23,,,2023-10-26,2020-09-23,2020-09-29,ACTUAL,,,,,,,2023-10-26,2023-10-30,ACTUAL,2020-11-13,ACTUAL,2020-11-13,2023-10,2023-10-31,2023-09-29,ACTUAL,2023-09-29,2023-09-29,ACTUAL,2023-09-29,,INTERVENTIONAL,,,Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS,"A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)",TERMINATED,,PHASE3,384.0,ACTUAL,Mitsubishi Tanabe Pharma America Inc.,,2.0,,Futility was met.,f,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,INDUSTRY,,,,,,,2023,0.0
NCT02776514,,2016-02-18,,,2022-01-27,2016-05-17,2016-05-18,ESTIMATED,,,,,,,2022-01-27,2022-02-07,ACTUAL,2016-02,,2016-02-29,2022-01,2022-01-31,2020-11,ACTUAL,2020-11-30,2020-11,ACTUAL,2020-11-30,,INTERVENTIONAL,KIT,,"Steroids, Hyaluronic Acid or Platelet Rich Plasma Versus Placebo for the Knee Osteoarthritis","Intraarticular Injections of Steroids, Hyaluronic Acid or Platelet Rich Plasma Versus Placebo for the Knee Osteoarthritis",COMPLETED,,PHASE2,120.0,ACTUAL,Balgrist University Hospital,,4.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,OTHER,,,,,,,2020,1.0
NCT03837509,,2019-02-07,2022-12-21,,2023-02-21,2019-02-07,2019-02-12,ACTUAL,2023-02-21,2023-03-20,ACTUAL,,,,2023-02-21,2023-03-20,ACTUAL,2019-09-25,ACTUAL,2019-09-25,2023-02,2023-02-28,2022-04-05,ACTUAL,2022-04-05,2022-04-05,ACTUAL,2022-04-05,,INTERVENTIONAL,,,"INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma","A Randomized Open-Label Phase 1/2 Study of INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Participants With Relapsed or Refractory Multiple Myeloma",TERMINATED,,PHASE1/PHASE2,15.0,ACTUAL,Incyte Corporation,The study was terminated following a recruitment challenge. There were no safety-related concerns.,3.0,,This decision follows recruitment difficulties. No safety-related concerns impacted this decision.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,INDUSTRY,,,,,,,2022,0.0
NCT05813314,,2023-03-16,,,2023-10-10,2023-04-02,2023-04-14,ACTUAL,,,,,,,2023-10-10,2023-10-12,ACTUAL,2023-03-15,ACTUAL,2023-03-15,2023-09,2023-09-30,2023-06-14,ACTUAL,2023-06-14,2023-06-14,ACTUAL,2023-06-14,,INTERVENTIONAL,,,Bioequivalence Study to Compare Two Injection Devices for BMN 111 in Healthy Participants,"A Phase 1, Randomized, Open-Label, Sponsor-Open, Two-Sequence, Two-Period Crossover Study to Investigate the Bioequivalence of a Single Subcutaneous Dose of BMN 111 Administered Using Either a Vial and Syringe or Injector Pen in Healthy Adult Participants",TERMINATED,,PHASE1,36.0,ACTUAL,BioMarin Pharmaceutical,,2.0,,The BMN 111-104 study has terminated as further optimization of the approach to achieve bio equivalence is required. The study termination was not due to any patient safety concerns.,f,,,,,t,t,t,,f,,,,,,,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,INDUSTRY,,,,,,,2023,0.0
NCT03518021,,2018-05-03,,,2020-10-07,2018-05-03,2018-05-08,ACTUAL,,,,,,,2020-10-07,2020-10-08,ACTUAL,2018-05-15,ACTUAL,2018-05-15,2020-10,2020-10-31,2020-10-06,ACTUAL,2020-10-06,2020-10-06,ACTUAL,2020-10-06,,INTERVENTIONAL,NINA-1,,Naloxone Nasal Spray Compared With Naloxone Injection for Opioid Overdoses Outside the Hospital,"NTNU Intranasal Naloxone Trial - a Double Blinded, Double Dummy, Randomized Controlled Trial of Intranasal Naloxone for Pre-hospital Use",COMPLETED,,PHASE3,286.0,ACTUAL,Norwegian University of Science and Technology,,4.0,,,f,,,,t,f,f,,,,,,"Updated regularly, but no later than one year after publication of main results",NTNU will require data processor agreements for recipients conform to standards set out in Norwegian Law and the European General Data Protection Regulation. Any shared datasets will have pseudonymisation of personal data. If doubt NTNU will seek advice from Ethics Committee.,https://dataverse.no/dataset.xhtml?persistentId=doi:10.18710/ABRUWW,YES,"NTNU has complete ownership and publishing rights of all results, regardless of outcome. The full protocol, Statistical Analysis Plan, information letter for consent and other trial documents will be published open access in the NTNU Open repository. The Clinical Study report and Statistical Analysis Report will also be made openly available, but open versions may be censored to ensure that it will not be possible to identify individual study participants. The datasets analysed during the current study will be made available from NTNU upon reasonable request and a methodological sound proposal based on the consent given by participants.",2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,OTHER,,,,,,,2020,0.0
NCT03205761,,2017-05-09,2023-10-26,,2024-05-08,2017-06-29,2017-07-02,ACTUAL,2024-04-30,2024-05-01,ACTUAL,,,,2024-05-08,2024-06-06,ACTUAL,2017-10-23,ACTUAL,2017-10-23,2024-05,2024-05-31,2022-12-15,ACTUAL,2022-12-15,2022-12-15,ACTUAL,2022-12-15,,INTERVENTIONAL,COMETABreast,,Analysis of Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer,A Phase II Clinical Trial to Analyse Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer (COMETA-Breast Study),COMPLETED,,PHASE2,11.0,ACTUAL,Spanish Breast Cancer Research Group,,1.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,OTHER,,,,,,,2022,0.0
NCT01722331,,2012-11-02,2018-03-28,,2022-02-23,2012-11-02,2012-11-06,ESTIMATED,2018-05-14,2018-06-13,ACTUAL,,,,2022-02-23,2022-03-23,ACTUAL,2012-12-06,ACTUAL,2012-12-06,2022-02,2022-02-28,2021-11-10,ACTUAL,2021-11-10,2015-10-28,ACTUAL,2015-10-28,,INTERVENTIONAL,reSURFACE 1,Overall Number of Baseline Participants includes randomized participants according to assigned treatment for Part 1 of the study.,"A Study to Evaluate the Efficacy and Safety of Subcutaneous MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-010)","A 64-Week, Phase 3, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-010)",COMPLETED,,PHASE3,772.0,ACTUAL,Sun Pharmaceutical Industries Limited,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,INDUSTRY,,,,,,,2021,1.0
NCT03094611,,2017-03-20,2021-02-01,,2021-03-17,2017-03-28,2017-03-29,ACTUAL,2021-03-17,2021-04-12,ACTUAL,,,,2021-03-17,2021-04-12,ACTUAL,2017-11-30,ACTUAL,2017-11-30,2021-03,2021-03-31,2020-03-11,ACTUAL,2020-03-11,2020-03-11,ACTUAL,2020-03-11,,INTERVENTIONAL,,,Inotuzumab Ozogamicin in Treating Patients With Relapsed or Refractory CD22 Positive Acute Lymphoblastic Leukemia,Phase II Study of Low Dose Inotuzumab Ozogamicin in Patients With Relapsed and Refractory CD22 Positive Acute Lymphocytic Leukemia,TERMINATED,,PHASE2,4.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,the study was closed early due to competing trials,f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,OTHER,,,,,,,2020,0.0
NCT04049617,,2019-07-31,2022-03-30,,2022-09-09,2019-08-06,2019-08-08,ACTUAL,2022-03-30,2022-08-10,ACTUAL,,,,2022-09-09,2022-10-06,ACTUAL,2019-08-26,ACTUAL,2019-08-26,2022-09,2022-09-30,2021-03-30,ACTUAL,2021-03-30,2021-03-30,ACTUAL,2021-03-30,,INTERVENTIONAL,,"Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.","Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Evixapodlin (Formerly GS-4224) in Participants With Advanced Solid Tumors","A Phase 1b/2 Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GS-4224 in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,18.0,ACTUAL,Gilead Sciences,"Due to early termination, the study did not proceed to dose expansion phase.",9.0,,Gilead decision to terminate,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,INDUSTRY,,,,,,,2021,0.0
NCT04206761,,2019-12-17,,,2021-11-29,2019-12-19,2019-12-20,ACTUAL,,,,,,,2021-11-29,2021-12-14,ACTUAL,2021-12-01,ESTIMATED,2021-12-01,2020-10,2020-10-31,2022-12-01,ESTIMATED,2022-12-01,2022-07-01,ESTIMATED,2022-07-01,,INTERVENTIONAL,XPERTT,,Investigating the Effects of QVM149 on MRI Ventilation Defects,Xenon MRI Probing vEntilation Response to Triple Therapy (QVM149),WITHDRAWN,,PHASE3,0.0,ACTUAL,"Western University, Canada",,2.0,,issues related to Covid-19 restrictions/shutdowns,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,OTHER,,,,,,,2022,0.0
NCT02502006,,2015-07-16,2023-09-11,,2023-11-21,2015-07-16,2015-07-17,ESTIMATED,2023-11-21,2023-12-13,ACTUAL,,,,2023-11-21,2023-12-13,ACTUAL,2015-11,,2015-11-30,2023-11,2023-11-30,2022-09,ACTUAL,2022-09-30,2022-09,ACTUAL,2022-09-30,,INTERVENTIONAL,,,Variability in Response to Non-steroidal Anti-inflammatory Drugs,"A Double-blind, Placebo-controlled Investigation of Inter-individual Variability in Pharmacologic Response to Non-steroidal Anti-inflammatory Drugs",TERMINATED,,PHASE1,16.0,ACTUAL,University of Pennsylvania,,2.0,,Funding was not available to complete enrollment,f,,,,f,,,,,,,,,,,,,2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,OTHER,,,,,,,2022,0.0
NCT05050006,,2021-09-09,,2024-02-26,2024-04-12,2021-09-09,2021-09-20,ACTUAL,,,,,,,2024-04-12,2024-04-16,ACTUAL,2021-10-07,ACTUAL,2021-10-07,2024-04,2024-04-30,2023-02-27,ACTUAL,2023-02-27,2023-02-27,ACTUAL,2023-02-27,,INTERVENTIONAL,DELTA-1,,ITIL-168 in Advanced Melanoma,"A Phase 2, Open-label, Multicenter Study Evaluating the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes (TILs) in Subjects With Advanced Melanoma (DELTA-1)",TERMINATED,,PHASE2,29.0,ACTUAL,Instil Bio,,3.0,,Business Decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,INDUSTRY,,,,,,,2023,0.0
NCT03858166,,2019-02-25,,,2024-01-03,2019-02-27,2019-02-28,ACTUAL,,,,,,,2024-01-03,2024-01-05,ACTUAL,2017-12-01,ACTUAL,2017-12-01,2024-01,2024-01-31,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Efficacy and Safety of PEG-rhG-CSF Secondary Prophylaxis vs. Therapeutic Administration in Patients With Ovarian Cancer,The Efficacy and Safety of Secondary Prophylaxis Versus ANC< 1000/mm3 Administration of PEG-rhG-CSF in Patients Receiving Cytotoxic Chemotherapy for Gynecologic Malignancies,TERMINATED,,PHASE4,68.0,ACTUAL,Shandong University,,2.0,,Sponsor Termination,f,,,,t,f,f,,,,,,,,,,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,OTHER,,,,,,,2020,0.0
NCT04009460,,2019-07-03,,,2022-04-22,2019-07-03,2019-07-05,ACTUAL,,,,,,,2022-04-22,2022-04-29,ACTUAL,2019-06-28,ACTUAL,2019-06-28,2022-04,2022-04-30,2022-04-22,ACTUAL,2022-04-22,2022-04-22,ACTUAL,2022-04-22,,INTERVENTIONAL,,,A Study of ES101 (PD-L1x4-1BB Bispecific Antibody) in Patients With Advanced Solid Tumors,"An Open-label, Multicenter, Dose-escalation and Cohort Expansion Phase 1 Clinical Study of ES101 in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1,22.0,ACTUAL,"Elpiscience Biopharma, Ltd.",,2.0,,Sponsor's clinical development strategy adjustment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,INDUSTRY,,,,,,,2022,0.0
NCT01951885,,2013-09-24,2022-09-13,,2023-08-16,2013-09-24,2013-09-27,ESTIMATED,2023-01-11,2023-01-31,ACTUAL,,,,2023-08-16,2023-09-11,ACTUAL,2014-07-07,ACTUAL,2014-07-07,2023-08,2023-08-31,2021-08-11,ACTUAL,2021-08-11,2020-10-09,ACTUAL,2020-10-09,,INTERVENTIONAL,,All participants that went on study,"Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention","Tacrolimus, Mini-dose Methotrexate and Mycophenolate Mofetil Versus Tacrolimus and Methotrexate for the Prevention of Acute Graft-versus-Host-Disease",COMPLETED,,PHASE3,101.0,ACTUAL,Case Comprehensive Cancer Center,,2.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,OTHER,,,,,,,2021,1.0
NCT04561375,,2020-09-11,2023-11-06,,2023-12-11,2020-09-22,2020-09-23,ACTUAL,2023-12-11,2023-12-13,ACTUAL,,,,2023-12-11,2023-12-13,ACTUAL,2020-12-11,ACTUAL,2020-12-11,2023-12,2023-12-31,2022-07-01,ACTUAL,2022-07-01,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,,,Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery,A Pilot Study Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery From Ambulatory Surgery,TERMINATED,,PHASE4,61.0,ACTUAL,The Cleveland Clinic,,2.0,,For practical reasons of slow enrollment,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,OTHER,,,,,,,2022,0.0
NCT05176691,,2021-11-19,,,2023-02-17,2021-12-14,2022-01-04,ACTUAL,,,,,,,2023-02-17,2023-02-21,ACTUAL,2022-02-15,ACTUAL,2022-02-15,2023-02,2023-02-28,2022-11-16,ACTUAL,2022-11-16,2022-11-16,ACTUAL,2022-11-16,,INTERVENTIONAL,,,HMPL-760 Safety and Tolerability Study in Patients With Previously Treated CLL/SLL or NHL,"A Multicenter, Open-label, Phase 1 Study Evaluating the Safety and Tolerability of HMPL-760 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Other Non-Hodgkin Lymphoma (NHL)",WITHDRAWN,,PHASE1,0.0,ACTUAL,Hutchmed,,1.0,,HUTCHMED has decided to discontinue the HMPL 760 study.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,INDUSTRY,,,,,,,2022,0.0
NCT04153409,,2019-11-04,2021-03-03,,2021-04-06,2019-11-04,2019-11-06,ACTUAL,2021-03-03,2021-03-30,ACTUAL,,,,2021-04-06,2021-04-28,ACTUAL,2019-09-24,ACTUAL,2019-09-24,2021-04,2021-04-30,2020-04-10,ACTUAL,2020-04-10,2020-02-15,ACTUAL,2020-02-15,,INTERVENTIONAL,,,A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine,A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine,COMPLETED,,PHASE2,21.0,ACTUAL,Lateral Pharma Pty Ltd,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,INDUSTRY,,,,,,,2020,1.0
NCT03296436,,2017-09-25,,,2019-02-25,2017-09-27,2017-09-28,ACTUAL,,,,,,,2019-02-25,2019-02-27,ACTUAL,2020-01,ESTIMATED,2020-01-31,2019-02,2019-02-28,2021-10,ESTIMATED,2021-10-31,2021-01,ESTIMATED,2021-01-31,,INTERVENTIONAL,,,A Pilot Study to Assess the Efficacy of NEOX® CORD 1K® in the Treatment of Complex Diabetic Wounds,A Pilot Study to Assess the Efficacy of NEOX® CORD 1K® in the Treatment of Complex Diabetic Wounds,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Johns Hopkins University,,1.0,,Sponsor decision - sponsor will be initiating a phase 3 mid-2019,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,OTHER,,,,,,,2021,0.0
NCT04032158,,2019-07-23,2021-05-31,,2021-07-13,2019-07-23,2019-07-25,ACTUAL,2021-07-13,2021-08-05,ACTUAL,,,,2021-07-13,2021-08-05,ACTUAL,2019-08-26,ACTUAL,2019-08-26,2021-07,2021-07-31,2020-04-16,ACTUAL,2020-04-16,2020-04-16,ACTUAL,2020-04-16,,INTERVENTIONAL,,,Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS),"A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With an Interferon Beta 1a (Avonex®), in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety",TERMINATED,,PHASE3,3.0,ACTUAL,EMD Serono,"Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0073. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study.",2.0,,"Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0073. Consequently, this trial terminated early.",f,,,,t,t,f,,,,,,,,,YES,"Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html",2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,INDUSTRY,,,,,,,2020,0.0
NCT05378945,,2022-05-13,,,2023-04-24,2022-05-13,2022-05-18,ACTUAL,,,,,,,2023-04-24,2023-04-25,ACTUAL,2022-07-22,ACTUAL,2022-07-22,2023-04,2023-04-30,2023-04-04,ACTUAL,2023-04-04,2023-04-04,ACTUAL,2023-04-04,,INTERVENTIONAL,,,Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease,"A Phase 3, Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease in Chinese Population",COMPLETED,,PHASE3,340.0,ACTUAL,"Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.",,2.0,,,f,,,,,t,f,,,t,,,,,,,,2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,INDUSTRY,,,,,,,2023,1.0
NCT00659126,,2008-04-10,2023-07-14,,2023-08-16,2008-04-14,2008-04-16,ESTIMATED,2023-08-16,2023-09-07,ACTUAL,,,,2023-08-16,2023-09-07,ACTUAL,2006-11-16,ACTUAL,2006-11-16,2023-08,2023-08-31,2020-12-31,ACTUAL,2020-12-31,2019-12-31,ACTUAL,2019-12-31,,INTERVENTIONAL,,,Ferumoxytol- and Gadolinium-Labeled MRI in Measuring Tumors Before or After Treatment in Patients With Primary or Metastatic Brain Tumors,A Phase II Study of Ferumoxytol and Gadolinium Magnetic Resonance Imaging at 3T and 7T in Subjects With Primary or Metastatic Brain Tumors Either Before or After Therapy,TERMINATED,,PHASE2,40.0,ACTUAL,OHSU Knight Cancer Institute,,1.0,,Loss of funding,f,,,,t,,,,,,,,,,,,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,OTHER,,,,,,,2020,0.0
NCT05351554,,2022-04-04,,2023-11-10,2024-01-31,2022-04-22,2022-04-28,ACTUAL,,,,,2023-11-18,ACTUAL,2024-01-31,2024-02-02,ACTUAL,2022-08-23,ACTUAL,2022-08-23,2023-11,2023-11-30,2022-12-13,ACTUAL,2022-12-13,2022-11-15,ACTUAL,2022-11-15,,INTERVENTIONAL,RESOLVE-Heart,,"A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis","A Randomized, Double-blind, Placebo-controlled, Phase 2a Study With an Open-label Cohort to Assess the Safety, Tolerability, and Efficacy of Namilumab in Subjects With Active Cardiac Sarcoidosis",TERMINATED,,PHASE2,1.0,ACTUAL,Kinevant Sciences GmbH,,3.0,,Sponsor business decision not related to safety,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,INDUSTRY,,,,,,,2022,0.0
NCT01881308,,2013-06-17,,,2022-04-24,2013-06-17,2013-06-19,ESTIMATED,,,,,,,2022-04-24,2022-04-26,ACTUAL,2013-06-17,ACTUAL,2013-06-17,2022-04,2022-04-30,2022-01,ACTUAL,2022-01-31,2020-01,ACTUAL,2020-01-31,,INTERVENTIONAL,ARCTIC REWIND,,Assessing Withdrawal of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis,REmission in Rheumatoid Arthritis - Assessing WIthrawal of Disease-modifying Antirheumatic Drugs in a Non-inferiority Design,COMPLETED,,PHASE4,320.0,ACTUAL,Diakonhjemmet Hospital,,5.0,,,f,,,,f,,,,,,,,Data will be available within 12 months of study completion.,"Data access requests will be reviewed by the study steering committee, and requestors will be required to sign a data access agreement.",,YES,The authors commit to making the relevant anonymized patient level data available on reasonable request.,2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,OTHER,,,,,,,2022,1.0
NCT02332928,,2014-12-16,2022-12-13,2022-03-15,2023-03-03,2015-01-05,2015-01-07,ESTIMATED,2023-03-03,2023-03-30,ACTUAL,2022-03-17,2022-03-21,ACTUAL,2023-03-03,2023-03-30,ACTUAL,2015-03-25,ACTUAL,2015-03-25,2023-03,2023-03-31,2021-06-02,ACTUAL,2021-06-02,2021-06-02,ACTUAL,2021-06-02,,INTERVENTIONAL,,,Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy,Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy: A Double Blind Placebo-Controlled Trial,TERMINATED,,PHASE3,80.0,ACTUAL,Virginia Commonwealth University,"The study had an initial goal of 142 patients, with interim analysis at half recruitment. Upon recommendation from the Data and Safety Monitoring Committee (DSMC), the study concluded at interim analysis due to lack of efficacy.",2.0,,Lack of efficacy,f,,,,t,t,f,,,,,,,,,,,2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,OTHER,,,,,,,2021,0.0
NCT04177693,,2019-11-20,2023-01-27,,2023-05-08,2019-11-22,2019-11-26,ACTUAL,2023-05-08,2023-06-05,ACTUAL,,,,2023-05-08,2023-06-05,ACTUAL,2020-11-24,ACTUAL,2020-11-24,2023-05,2023-05-31,2022-01-31,ACTUAL,2022-01-31,2022-01-31,ACTUAL,2022-01-31,,INTERVENTIONAL,,,Pharmacokinetics and Hepatic Safety of EGCG,Pharmacokinetics and Hepatic Safety of EGCG,COMPLETED,,PHASE1,39.0,ACTUAL,Yale University,,3.0,,,,,,,t,t,f,,,,,,,,,,,2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,OTHER,,,,,,,2022,1.0
NCT02601209,,2015-11-09,2019-12-30,,2022-07-27,2015-11-09,2015-11-10,ESTIMATED,2020-02-20,2020-03-03,ACTUAL,,,,2022-07-27,2022-08-23,ACTUAL,2015-11-30,ACTUAL,2015-11-30,2022-07,2022-07-31,2022-07-11,ACTUAL,2022-07-11,2018-12-07,ACTUAL,2018-12-07,,INTERVENTIONAL,,Registered Phase I patients and Randomized Phase II patients,Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma,A Phase I/Randomized Phase II Study of MLN0128 (TAK-228) VS. Pazopanib in Patients With Locally Advanced/Unresectable and/or Metastatic Sarcoma,TERMINATED,,PHASE1/PHASE2,151.0,ACTUAL,National Cancer Institute (NCI),,2.0,,Interim monitoring,f,,,,f,,,,,,,,,,,,,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,NIH,,,,,,,2022,0.0
NCT05438251,,2022-06-24,,,2024-05-13,2022-06-24,2022-06-29,ACTUAL,,,,,,,2024-05-13,2024-05-16,ACTUAL,2022-08-04,ACTUAL,2022-08-04,2024-05,2024-05-31,2024-04-03,ACTUAL,2024-04-03,2024-04-03,ACTUAL,2024-04-03,,INTERVENTIONAL,,,"Exploring the Effect of Fespixon Cream for the Treatment of Diabetic Foot Ulcers (TEXAS 3A, 3B)","Exploring the Effect of Fespixon Cream for the Treatment of Diabetic Foot Ulcers (TEXAS 3A, 3B)",TERMINATED,,PHASE4,3.0,ACTUAL,"Oneness Biotech Co., Ltd.",,1.0,,Study halted prematurely and will not resume.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,INDUSTRY,,,,,,,2024,0.0
NCT03791398,,2018-12-26,2022-04-28,,2023-02-15,2018-12-31,2019-01-02,ACTUAL,2022-05-25,2022-06-21,ACTUAL,,,,2023-02-15,2023-02-17,ACTUAL,2019-11-15,ACTUAL,2019-11-15,2023-02,2023-02-28,2021-08-05,ACTUAL,2021-08-05,2021-06-16,ACTUAL,2021-06-16,,INTERVENTIONAL,379,No patients were enrolled to dose level 2 or 3.,BrUOG 379 Phase Ib/II Trial ONC201 + Nivolumab in MSS mCRC,BrUOG 379: A Phase Ib/II Single Arm Study of ONC201 Plus Nivolumab in Microsatellite Stable (MSS) Metastatic Colorectal Cancer (mCRC) Patients,TERMINATED,,PHASE1/PHASE2,13.0,ACTUAL,Brown University,,4.0,,Lack of efficacy,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,OTHER,,,,,,,2021,0.0
NCT02908490,,2016-07-08,2021-05-31,,2021-07-20,2016-09-16,2016-09-21,ESTIMATED,2021-07-20,2021-08-13,ACTUAL,,,,2021-07-20,2021-08-13,ACTUAL,2017-04-01,ACTUAL,2017-04-01,2021-07,2021-07-31,2020-12-31,ACTUAL,2020-12-31,2020-06-04,ACTUAL,2020-06-04,,INTERVENTIONAL,,,Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis?,Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis?,TERMINATED,,PHASE2,25.0,ACTUAL,University of Pittsburgh,,2.0,,"Slow recruitment, lack of continued funding",f,,,,f,t,f,,,f,,,,,,YES,,2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,OTHER,,,,,,,2020,0.0
NCT04210843,,2019-12-17,2023-02-15,,2024-06-17,2019-12-22,2019-12-26,ACTUAL,2023-06-20,2023-07-13,ACTUAL,,,,2024-06-17,2024-06-20,ACTUAL,2020-04-08,ACTUAL,2020-04-08,2024-06,2024-06-30,2022-09-01,ACTUAL,2022-09-01,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,,,Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab,"A Multi-center, Double-blinded and Open-label Extension Study to Evaluate the Efficacy and Safety of Ligelizumab as Retreatment, Self-administered Therapy and Monotherapy in Chronic Spontaneous Urticaria Patients Who Completed Studies CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301",TERMINATED,,PHASE3,1033.0,ACTUAL,Novartis,,2.0,,Study was terminated due to a strategic decision by Novartis to discontinue development of ligelizumab in CSU. This decision was not based on any safety concerns.,f,,,,t,t,f,,,,,,,,,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,INDUSTRY,,,,,,,2022,0.0
NCT02689453,,2016-02-20,2022-03-31,,2022-04-27,2016-02-20,2016-02-24,ESTIMATED,2022-04-27,2022-04-29,ACTUAL,,,,2022-04-27,2022-04-29,ACTUAL,2017-01-19,ACTUAL,2017-01-19,2022-04,2022-04-30,2021-06-15,ACTUAL,2021-06-15,2021-06-15,ACTUAL,2021-06-15,,INTERVENTIONAL,,,Subcutaneous Recombinant Human IL-15 (s.c. rhIL-15) and Alemtuzumab for People With Refractory or Relapsed Chronic and Acute Adult T-cell Leukemia (ATL),A Phase I Study of Subcutaneous Recombinant Human IL-15 (S.C. Rhil-15) and Alemtuzumab for Patients With Refractory or Relapsed Chronic and Acute Adult T-Cell Leukemia (ATL),COMPLETED,,PHASE1,11.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,,f,,,,f,t,f,,,,,,Clinical data available during the study and indefinitely.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).,,YES,All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,NIH,,,,,,,2021,1.0
NCT05008510,,2021-08-10,,,2022-01-24,2021-08-10,2021-08-17,ACTUAL,,,,,,,2022-01-24,2022-02-08,ACTUAL,2021-12-30,ESTIMATED,2021-12-30,2022-01,2022-01-31,2023-06-30,ESTIMATED,2023-06-30,2022-07-30,ESTIMATED,2022-07-30,,INTERVENTIONAL,VERU-111,,P2 Clinical Efficacy & Safety Study of V-111 Monotherapy & Sacituzumab Govitecan-hziy/V-111 Combo Therapy for mTNBC .,Phase 2 Clinical Efficacy and Safety Study of Sabizabulin (VERU-111) Monotherapy and Sacituzumab Govitecan-hziy/Sabizabulin Combination Therapy for the Treatment of Metastatic Triple Negative Breast Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,Veru Inc.,,3.0,,Decided to halt and will potentially reopen in the future.,f,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,INDUSTRY,,,,,,,2023,0.0
NCT04317300,,2020-02-14,,,2023-02-06,2020-03-20,2020-03-23,ACTUAL,,,,,,,2023-02-06,2023-02-08,ACTUAL,2023-02-01,ACTUAL,2023-02-01,2023-02,2023-02-28,2023-02-01,ACTUAL,2023-02-01,2023-02-01,ACTUAL,2023-02-01,,INTERVENTIONAL,VAPEscape,,Feasibility of Treatment for Vaping Cessation,The Feasibility of Treatment for Vaping Cessation,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Mayo Clinic,,1.0,,medication has not been available for the intervention,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,OTHER,,,,,,,2023,0.0
NCT02749292,,2016-03-01,2023-02-03,,2023-07-06,2016-04-19,2016-04-22,ESTIMATED,2023-07-06,2023-07-27,ACTUAL,,,,2023-07-06,2023-07-27,ACTUAL,2016-06,,2016-06-30,2023-07,2023-07-31,2022-01-31,ACTUAL,2022-01-31,2022-01-31,ACTUAL,2022-01-31,,INTERVENTIONAL,MAINTANCAVAS,,Maintenance of ANCA Vasculitis Remission by Intermittent Rituximab Dosing,Maintenance of ANCA Vasculitis Remission by Intermittent Rituximab Dosing Based on B-cell Reconstitution vs a Serologic ANCA Flare,TERMINATED,,PHASE4,115.0,ACTUAL,Massachusetts General Hospital,The trial has several limitations:~1. It was open-label.~2. it only enrolled patients on continuous B cell depletion for a minimum of 2 years~3. it took place in a single center.,2.0,,"Due to the coronavirus disease 2019 (COVID-19) pandemic and the deleterious impact of rituximab on vaccination efficacy, the trial was concluded before reaching the target enrollment of 200.",f,,,,f,,,,,,,,,,,NO,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,OTHER,,,,,,,2022,0.0
NCT04940949,,2021-05-27,,,2023-03-15,2021-06-18,2021-06-28,ACTUAL,,,,,,,2023-03-15,2023-03-16,ACTUAL,2021-05-26,ACTUAL,2021-05-26,2023-03,2023-03-31,2021-11-23,ACTUAL,2021-11-23,2021-11-23,ACTUAL,2021-11-23,,INTERVENTIONAL,,,A Study to Evaluate Lu AF90103 in Healthy Men,"Interventional, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study Part Investigating the Safety, Tolerability, and Pharmacokinetic and -Dynamic Properties of Lu AF90103 and a Double-Blind, Cross-Over Study Part Investigating the Safety Profile After Infusion of Lu AF90103 at Two Rates to Healthy Men",TERMINATED,,PHASE1,15.0,ACTUAL,H. Lundbeck A/S,,3.0,,The study was terminated based on new safety data.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,INDUSTRY,,,,,,,2021,0.0
NCT02660528,,2016-01-19,2020-09-17,,2020-10-16,2016-01-19,2016-01-21,ESTIMATED,2020-10-16,2020-10-20,ACTUAL,,,,2020-10-16,2020-10-20,ACTUAL,2016-04,ACTUAL,2016-04-30,2020-10,2020-10-31,2020-06,ACTUAL,2020-06-30,2020-06,ACTUAL,2020-06-30,,INTERVENTIONAL,,,Tocilizumab Augmentation in Treatment-Refractory Major Depressive Disorder,Tocilizumab Augmentation in Treatment-Refractory Major Depressive Disorder: An Open-Label Trial,TERMINATED,,PHASE2,3.0,ACTUAL,Brigham and Women's Hospital,,1.0,,Study staff change.,f,,,,f,,,,,,,,,,,,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,OTHER,,,,,,,2020,0.0
NCT03397446,,2017-12-20,,,2020-11-25,2018-01-10,2018-01-12,ACTUAL,,,,,,,2020-11-25,2020-11-27,ACTUAL,2018-06-21,ACTUAL,2018-06-21,2020-11,2020-11-30,2020-05-19,ACTUAL,2020-05-19,2020-05-19,ACTUAL,2020-05-19,,INTERVENTIONAL,,,Lisdexamfetamine for Adults With Bulimia Nervosa,A Feasibility Study to Evaluate Lisdexamfetamine Dimesylate (Vyvanse) in Adults With Bulimia Nervosa,TERMINATED,,PHASE2,23.0,ACTUAL,Nova Scotia Health Authority,,1.0,,"Loss of resources due to COVID-19 resulted in insufficient funds to complete the trial as planned. However, sufficient data was collected to fulfill the aims of the trial. Discontinuation is not related to the drug, its use, or adverse events.",f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,OTHER,,,,,,,2020,0.0
NCT05387707,,2022-05-19,,,2024-02-21,2022-05-19,2022-05-24,ACTUAL,,,,,,,2024-02-21,2024-02-22,ACTUAL,2022-08-16,ACTUAL,2022-08-16,2024-02,2024-02-29,2024-02-02,ACTUAL,2024-02-02,2024-02-02,ACTUAL,2024-02-02,,INTERVENTIONAL,KIND-1,,Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis,"A Two-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate-to-Severe Pruritus in Adult Subjects With Atopic Dermatitis",TERMINATED,,PHASE3,287.0,ACTUAL,"Cara Therapeutics, Inc.",,4.0,,"In Part A of the study, oral difelikefalin as adjunct to topical corticosteroids (TCS) did not demonstrate meaningful clinical benefit compared to TCS alone.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,INDUSTRY,,,,,,,2024,0.0
NCT02674061,,2016-02-02,2020-09-01,,2022-02-23,2016-02-02,2016-02-04,ESTIMATED,2020-09-01,2020-09-22,ACTUAL,,,,2022-02-23,2022-03-24,ACTUAL,2016-02-25,ACTUAL,2016-02-25,2022-02,2022-02-28,2021-03-18,ACTUAL,2021-03-18,2019-09-18,ACTUAL,2019-09-18,,INTERVENTIONAL,,,Efficacy and Safety Study of Pembrolizumab (MK-3475) in Participants With Advanced Recurrent Ovarian Cancer (MK-3475-100/KEYNOTE-100),"A Phase II, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of Pembrolizumab Monotherapy in Subjects With Advanced Recurrent Ovarian Cancer (KEYNOTE-100)",COMPLETED,,PHASE2,376.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,f,,,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,INDUSTRY,,,,,,,2021,1.0
NCT01790035,,2013-02-08,,,2022-03-01,2013-02-08,2013-02-12,ESTIMATED,,,,,,,2022-03-01,2022-03-16,ACTUAL,2014-08-19,ACTUAL,2014-08-19,2022-03,2022-03-31,2021-12-12,ACTUAL,2021-12-12,2017-01-12,ACTUAL,2017-01-12,,INTERVENTIONAL,LGG,,Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer,A Phase I and Randomized Controlled Phase II Trial of the Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer,TERMINATED,,PHASE1,23.0,ACTUAL,Washington University School of Medicine,,3.0,,Low accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,OTHER,,,,,,,2021,0.0
NCT03905564,,2019-02-20,,,2019-07-10,2019-04-04,2019-04-05,ACTUAL,,,,,,,2019-07-10,2019-07-11,ACTUAL,2019-06,ESTIMATED,2019-06-30,2019-07,2019-07-31,2020-06,ESTIMATED,2020-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,A Study to Investigate Differences in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions,"Single Site, Open-label, Randomized, Two Treatments, Two Periods, Two Sequences, Crossover Trial to Evaluate the Bioequivalence of Two Delayed-release Oral Formulations of a Fixed Combination of Doxylamine Succinate 10 mg/Pyridoxine Hydrochloride 10 mg (Test Product: Product of Tecnandina, S.A. TENSA; Reference Product: Diclegis (Registered Trademark) Product of Duchesnay Inc.) After a Single Administration of Two Tablets to Healthy Women Under Fasting Conditions",WITHDRAWN,,PHASE1,0.0,ACTUAL,Grünenthal GmbH,,2.0,,Sponsor decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,INDUSTRY,,,,,,,2020,0.0
NCT04432103,,2020-06-12,,,2021-07-30,2020-06-12,2020-06-16,ACTUAL,,,,,,,2021-07-30,2021-08-02,ACTUAL,2020-08-08,ACTUAL,2020-08-08,2021-07,2021-07-31,2021-01-29,ACTUAL,2021-01-29,2021-01-29,ACTUAL,2021-01-29,,INTERVENTIONAL,,,Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma,Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma,TERMINATED,,PHASE3,6.0,ACTUAL,Centro Medico ABC,,2.0,,There is new evidence that the Convalescent plasma is not useful for severe and critical COVID-19 Pneumonia,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,OTHER,,,,,,,2021,0.0
NCT04542681,,2018-12-18,,,2023-03-07,2020-09-02,2020-09-09,ACTUAL,,,,,,,2023-03-07,2023-03-09,ACTUAL,2018-05-01,ACTUAL,2018-05-01,2023-03,2023-03-31,2023-06-30,ESTIMATED,2023-06-30,2022-12-30,ESTIMATED,2022-12-30,,INTERVENTIONAL,MANP-2,,MANP in African Americans With Hypertension,"A Phase I, Single-Blind, Placebo-Controlled Study Evaluating the Cardiovascular Properties of MANP in African Americans With Hypertension",WITHDRAWN,,PHASE1,0.0,ACTUAL,Mayo Clinic,,3.0,,Study was withdrawn and replaced by a larger study,f,,,,t,t,f,,,,,,,,,,,2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,OTHER,,,,,,,2023,0.0
NCT03038620,,2017-01-30,2021-09-13,,2021-10-20,2017-01-30,2017-01-31,ESTIMATED,2021-10-20,2021-11-19,ACTUAL,,,,2021-10-20,2021-11-19,ACTUAL,2017-01,ACTUAL,2017-01-31,2021-10,2021-10-31,2020-10-13,ACTUAL,2020-10-13,2020-10-13,ACTUAL,2020-10-13,,INTERVENTIONAL,,Participants analyzed if they completed an endpoint assessment and had interpretable imaging data.,Impact of Liraglutide 3.0 on Body Fat Distribution,"Impact of Liraglutide 3.0 on Body Fat Distribution, Visceral Adiposity, and Cardiometabolic Risk Markers In Overweight and Obese Adults at High Risk for Cardiovascular Disease",COMPLETED,,PHASE4,235.0,ACTUAL,University of Texas Southwestern Medical Center,Results reported according to updated statistical analysis plan published 7/28/2020 on CT.gov website. The updated 7/28/2020 analysis plan accounted for changes in data collection (blood biomarkers) during COVID-19 pandemic and was submitted and published prior to study completion and prior to study un-blinding with updated terminology for study endpoints compared to original protocol.,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,OTHER,,,,,,,2020,1.0
NCT02790710,,2016-05-26,,,2023-04-12,2016-06-03,2016-06-06,ESTIMATED,,,,,,,2023-04-12,2023-04-18,ACTUAL,2016-06,ACTUAL,2016-06-30,2023-04,2023-04-30,2023-04,ACTUAL,2023-04-30,2023-04,ACTUAL,2023-04-30,,INTERVENTIONAL,,,Brief Intervention for OCD Fears,Brief Intervention for OCD Fears,WITHDRAWN,,PHASE4,0.0,ACTUAL,New York State Psychiatric Institute,,2.0,,Study has been withdrawn due to reconsideration of study design.,f,,,,f,,,,,,,,,,,NO,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,OTHER,,,,,,,2023,0.0
NCT04430855,,2020-06-11,2023-01-10,2022-03-22,2023-01-10,2020-06-11,2020-06-12,ACTUAL,2023-01-10,2023-02-06,ACTUAL,2022-03-22,2022-03-24,ACTUAL,2023-01-10,2023-02-06,ACTUAL,2020-07-14,ACTUAL,2020-07-14,2023-01,2023-01-31,2022-01-25,ACTUAL,2022-01-25,2021-04-22,ACTUAL,2021-04-22,,INTERVENTIONAL,,The Intent-to-treat (ITT) population includes all randomized participants,A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms,"A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa",COMPLETED,,PHASE2,68.0,ACTUAL,AbbVie,,2.0,,,f,,,,t,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,INDUSTRY,,,,,,,2022,1.0
NCT05442684,,2022-06-16,,,2023-06-14,2022-06-28,2022-07-05,ACTUAL,,,,,,,2023-06-14,2023-06-18,ACTUAL,2022-11-30,ESTIMATED,2022-11-30,2022-10,2022-10-31,2023-06-30,ESTIMATED,2023-06-30,2023-03-30,ESTIMATED,2023-03-30,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Immunogenicity of Ad5-vector Based Vaccine Against Coronavirus Variants in Adults (≥18 Years) Immunized With 2 Doses of mRNA Vaccines Plus One Dose of Booster AZD1222 Vaccine,"A Multicenter, Randomized, and Observer-blind Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-based COVID-19 Vaccine Against Coronavirus Variants in Adults (≥ 18 Years) Who Have Been Immunized With 2 Doses of mRNA Vaccines Plus One Dose of Booster AZD1222 Vaccine",WITHDRAWN,,PHASE3,0.0,ACTUAL,CanSino Biologics Inc.,,3.0,,The trial protocol was not approved by the regulatory authorities.,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,INDUSTRY,,,,,,,2023,0.0
NCT04361149,,2020-04-17,,,2020-04-21,2020-04-21,2020-04-24,ACTUAL,,,,,,,2020-04-21,2020-04-24,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2020-04,2020-04-30,2020-03-10,ACTUAL,2020-03-10,2019-12-20,ACTUAL,2019-12-20,,INTERVENTIONAL,,,Motor Unit Abnormalities After Experimentally Induced Sensitization,"Evaluation of Motor Unit Abnormalities After Experimentally Induced Sensitization Using Capsaicin: A Randomized, Double-Blinded, Placebo-Controlled Study",COMPLETED,,PHASE4,23.0,ACTUAL,Toronto Rehabilitation Institute,,2.0,,,f,,,,f,t,t,,,t,,,,,,NO,"The University Health Network has a high importance on patient confidentiality. For ethics approval, this was complied with these standards, upholding the patient confidentiality standard at UHN.",2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,OTHER,,,,,,,2020,1.0
NCT00418821,,2007-01-03,2023-12-11,,2024-02-16,2007-01-04,2007-01-05,ESTIMATED,2024-02-16,2024-02-20,ACTUAL,,,,2024-02-16,2024-02-20,ACTUAL,2010-10-22,ACTUAL,2010-10-22,2024-02,2024-02-29,2022-12-21,ACTUAL,2022-12-21,2022-12-21,ACTUAL,2022-12-21,,INTERVENTIONAL,,,A Study of the Effect of Aldurazyme® (Laronidase) Treatment on Lactation in Female Patients With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants,"A Multicenter, Multinational, Open-Label Study of the Effects of Aldurazyme® (Laronidase) Treatment on Lactation in Women With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants",TERMINATED,,PHASE4,2.0,ACTUAL,Sanofi,"Study was conducted to fulfill a post marketing commitment (PMC). Upon acknowledgement of closure of PMC by FDA, the study was terminated by the Sponsor.",1.0,,Study was conducted to fulfill a post marketing commitment (PMC). FDA acknowledged closure of PMC.,f,,,,f,,,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 18:33:44.882275,2024-10-16 18:33:44.882275,INDUSTRY,,,,,,,2022,0.0
NCT04836533,,2021-03-29,,,2023-03-27,2021-04-05,2021-04-08,ACTUAL,,,,,,,2023-03-27,2023-03-28,ACTUAL,2023-01-31,ACTUAL,2023-01-31,2021-03,2021-03-31,2023-01-31,ACTUAL,2023-01-31,2023-01-31,ACTUAL,2023-01-31,,INTERVENTIONAL,,,Enhancing Processing Speed and Executive Functioning in Depressed Older Adults With Computerized Cognitive Training,Optimizing Placebo Effects in Depressed Older Adults: Enhancing Processing Speed and Executive Functioning With Computerized Cognitive Training,WITHDRAWN,,PHASE1,0.0,ACTUAL,"Queens College, The City University of New York",,4.0,,Conflicts at the study site prevented the study from being carried out,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,OTHER,,,,,,,2023,0.0
NCT04249167,,2020-01-27,,,2023-01-05,2020-01-29,2020-01-30,ACTUAL,,,,,,,2023-01-05,2023-01-06,ACTUAL,2020-01-23,ACTUAL,2020-01-23,2021-12,2021-12-31,2021-11-17,ACTUAL,2021-11-17,2021-11-17,ACTUAL,2021-11-17,,INTERVENTIONAL,,,"Cryoablation, Atezolizumab/Nab-paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer",Cryoablation and Anti-PD-L1 Immunotherapy for Triple Negative Breast Cancer (TNBC),WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Mayo Clinic,,1.0,,study was dropped,f,,,,t,t,f,,,,,,,,,,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,OTHER,,,,,,,2021,0.0
NCT02373241,,2015-02-05,2022-02-24,,2024-04-01,2015-02-20,2015-02-26,ESTIMATED,2022-05-05,2022-05-09,ACTUAL,,,,2024-04-01,2024-04-03,ACTUAL,2015-04,,2015-04-30,2024-04,2024-04-30,2021-07,ACTUAL,2021-07-31,2021-02,ACTUAL,2021-02-28,,INTERVENTIONAL,,1 patient identified as eligible for the study due to ambulatory hypertension,Preventing Sickle Cell Kidney Disease,Chronobiology and Chronopharmacology to Prevent Sickle Cell Kidney Disease,TERMINATED,,PHASE2,1.0,ACTUAL,University of Alabama at Birmingham,,2.0,,Estimated GFR was determined not to be a reliable endpoint for this study. We identified significant variabilty in annual eGFR that it became inappropriate to randomize to a medication but use EGFR as the primary endpoint.,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,OTHER,,,,,,,2021,0.0
NCT03743805,,2018-11-08,,,2021-07-20,2018-11-14,2018-11-16,ACTUAL,,,,,,,2021-07-20,2021-07-27,ACTUAL,2019-01-01,ACTUAL,2019-01-01,2021-07,2021-07-31,2021-07-21,ACTUAL,2021-07-21,2021-07-20,ESTIMATED,2021-07-20,,INTERVENTIONAL,,,Rapid Reversal of CNS-Depressant Drug Effect Prior to Brain Death Determination,Rapid Reversal of CNS-Depressant Drug Effect Prior to Brain Death Determination,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Prisma Health-Midlands,,1.0,,Insufficient patients,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,OTHER,,,,,,,2021,0.0
NCT03209869,,2017-06-13,,,2022-09-12,2017-07-03,2017-07-06,ACTUAL,,,,,,,2022-09-12,2022-09-13,ACTUAL,2018-03-12,ACTUAL,2018-03-12,2022-09,2022-09-30,2022-09-07,ACTUAL,2022-09-07,2022-09-07,ACTUAL,2022-09-07,,INTERVENTIONAL,,,Treatment of Relapsed or Refractory Neuroblastoma and Osteosarcoma With Expanded Haploidentical NK Cells and Hu14.18-IL2,Treatment of Relapsed or Refractory Neuroblastoma and Osteosarcoma With Ex-Vivo Expanded and Activated Haploidentical NK Cells and Hu14.18-IL2,WITHDRAWN,,PHASE1,0.0,ACTUAL,"University of Wisconsin, Madison",,1.0,,resources limited due to COVID-19,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,OTHER,,,,,,,2022,0.0
NCT04321460,,2020-03-24,2021-12-29,,2021-12-29,2020-03-24,2020-03-25,ACTUAL,2021-12-29,2022-03-14,ACTUAL,,,,2021-12-29,2022-03-14,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2021-12,2021-12-31,2021-01-04,ACTUAL,2021-01-04,2021-01-04,ACTUAL,2021-01-04,,INTERVENTIONAL,,,"Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults.","Multicentre, Double-blind, Randomized, Placebo-controlled, Parallel-group Efficacy and Safety Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults.",COMPLETED,,PHASE3,520.0,ACTUAL,Sandoz,,2.0,,,f,,,,,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 12:31:11.358377,2024-10-15 12:31:11.358377,INDUSTRY,,,,,,,2021,1.0
NCT04489537,,2020-07-24,,,2021-12-02,2020-07-24,2020-07-28,ACTUAL,,,,,,,2021-12-02,2021-12-17,ACTUAL,2021-05-04,ACTUAL,2021-05-04,2021-12,2021-12-31,2021-12-01,ACTUAL,2021-12-01,2021-11-15,ACTUAL,2021-11-15,,INTERVENTIONAL,,,Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B,"Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous Marzeptacog Alfa (Activated) For On Demand Treatment and Control of Bleeding Episodes in Subjects With Hemophilia A or Hemophilia B, With Inhibitors: The Crimson 1 Study",TERMINATED,,PHASE3,18.0,ACTUAL,Catalyst Biosciences,,2.0,,Sponsor decision (not a safety decision),f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:11:39.845745,2024-10-16 09:11:39.845745,INDUSTRY,,,,,,,2021,0.0
NCT04862741,,2021-03-10,,,2023-02-13,2021-04-23,2021-04-28,ACTUAL,,,,,,,2023-02-13,2023-02-15,ACTUAL,2021-05-05,ACTUAL,2021-05-05,2023-02,2023-02-28,2022-10-05,ACTUAL,2022-10-05,2022-06-17,ACTUAL,2022-06-17,,INTERVENTIONAL,,,"Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis","A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis",COMPLETED,,PHASE1,39.0,ACTUAL,Landos Biopharma Inc.,,4.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 09:17:24.908599,2024-10-16 09:17:24.908599,INDUSTRY,,,,,,,2022,1.0
NCT02025881,,2013-12-30,,,2024-05-23,2013-12-30,2014-01-01,ESTIMATED,,,,,,,2024-05-23,2024-05-24,ACTUAL,2013-09-14,ACTUAL,2013-09-14,2024-05,2024-05-31,2020-10-25,ACTUAL,2020-10-25,2020-10-25,ACTUAL,2020-10-25,,INTERVENTIONAL,HR MB-5,,Study of Sequential High-dose Chemotherapy in Children With High Risk Medulloblastoma,Phase I / II Study of Sequential High-dose Chemotherapy With Stem Cell Support in Children Younger Than 5 Years of Age With High-risk Medulloblastoma,TERMINATED,,PHASE1/PHASE2,29.0,ACTUAL,"Gustave Roussy, Cancer Campus, Grand Paris",,1.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,OTHER,,,,,,,2020,0.0
NCT01478698,,2011-11-21,,,2022-05-12,2011-11-22,2011-11-23,ESTIMATED,,,,,,,2022-05-12,2022-05-19,ACTUAL,2016-01-01,ACTUAL,2016-01-01,2022-05,2022-05-31,2022-05-13,ACTUAL,2022-05-13,2022-05-13,ACTUAL,2022-05-13,,INTERVENTIONAL,,,The Safety and Tolerability of Intra-abdominal t-PA and DNase on Peritonitis in Peritoneal Dialysis Patients,"A Phase 1, Open Label, Non Randomised Safety Trial of Intraperitoneal tPA and DNase in Peritoneal Dialysis Patients With Peritonitis",TERMINATED,,PHASE1,5.0,ACTUAL,Sir Charles Gairdner Hospital,,4.0,,Insufficient budget for further study agents,f,,,,t,,,,,,,,,,,,,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,OTHER,,,,,,,2022,0.0
NCT02571608,,2015-09-29,,,2021-10-01,2015-10-06,2015-10-08,ESTIMATED,,,,,,,2021-10-01,2021-10-08,ACTUAL,2022-01-01,ESTIMATED,2022-01-01,2021-10,2021-10-31,2022-12-31,ESTIMATED,2022-12-31,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,CANTAKE,,Continuation of Metformin to Improve And Keep Peri-operative Glycemic Control,"ContinuAtioN of meTformin to Improve And KEep Peri-operative Glycemic Control: A Randomized, Double-Blind, Placebo-Controlled Pilot Study.",WITHDRAWN,,PHASE4,0.0,ACTUAL,McMaster University,,2.0,,"Study halted prematurely, prior to enrollment of first participant",f,,,,f,f,f,,,,,,,,,,,2024-10-16 09:17:24.908599,2024-10-16 09:17:24.908599,OTHER,,,,,,,2022,0.0
NCT03028740,,2017-01-13,2022-01-04,,2022-02-11,2017-01-18,2017-01-23,ESTIMATED,2022-02-11,2022-03-10,ACTUAL,,,,2022-02-11,2022-03-10,ACTUAL,2017-04-05,ACTUAL,2017-04-05,2021-11,2021-11-30,2021-03-09,ACTUAL,2021-03-09,2021-01-12,ACTUAL,2021-01-12,,INTERVENTIONAL,AURORA,Modified Intent-to-Treat (mITT) Population for the Full Study Cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined.,AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH),"AURORA: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis",TERMINATED,,PHASE3,1778.0,ACTUAL,"Tobira Therapeutics, Inc.",,2.0,,This study was terminated early due to lack of efficacy based on the results of the planned interim analysis of Part 1 data.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,INDUSTRY,,,,,,,2021,0.0
NCT03923530,,2019-04-18,2020-02-27,,2020-05-14,2019-04-19,2019-04-22,ACTUAL,2020-05-14,2020-05-28,ACTUAL,,,,2020-05-14,2020-05-28,ACTUAL,2019-06-03,ACTUAL,2019-06-03,2020-05,2020-05-31,2020-02-27,ACTUAL,2020-02-27,2020-02-20,ACTUAL,2020-02-20,,INTERVENTIONAL,,12,Pressure Assessment to Improve Outcomes After TAVR: a Registry,Pressure Assessment to Improve Outcomes After TAVR: a Registry,COMPLETED,,EARLY_PHASE1,12.0,ACTUAL,North Florida Foundation for Research and Education,,1.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,OTHER,,,,,,,2020,1.0
NCT03851081,,2019-02-19,,,2022-01-13,2019-02-20,2019-02-22,ACTUAL,,,,,,,2022-01-13,2022-01-28,ACTUAL,2021-01-21,ACTUAL,2021-01-21,2022-01,2022-01-31,2024-01-21,ESTIMATED,2024-01-21,2023-01-21,ESTIMATED,2023-01-21,,INTERVENTIONAL,,,Inotuzumab Ozogamicin and Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia,"A Multi-Center, Open-Label Phase 1b/2 Study of Inotuzumab Ozogamicin and Vincristine Sulfate Liposome in Adult Patients With Relapsed/Refractory B Lineage Acute Lymphoblastic Leukemia (B-ALL)",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Roswell Park Cancer Institute,,1.0,,no accrual,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,OTHER,,,,,,,2024,0.0
NCT03556761,,2018-06-01,2020-08-02,,2020-08-26,2018-06-01,2018-06-14,ACTUAL,2020-08-26,2020-09-10,ACTUAL,,,,2020-08-26,2020-09-10,ACTUAL,2018-06-20,ACTUAL,2018-06-20,2020-08,2020-08-31,2020-02-05,ACTUAL,2020-02-05,2019-12-04,ACTUAL,2019-12-04,,INTERVENTIONAL,ForBP,,Furosemide for Accelerated Recovery of Blood Pressure Postpartum,Furosemide for Accelerated Recovery of Blood Pressure Postpartum,COMPLETED,,PHASE2,384.0,ACTUAL,University of Pennsylvania,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,OTHER,,,,,,,2020,1.0
NCT05734482,,2023-01-29,,,2024-04-09,2023-02-15,2023-02-21,ACTUAL,,,,,,,2024-04-09,2024-04-10,ACTUAL,2023-02-15,ACTUAL,2023-02-15,2024-04,2024-04-30,2023-07-03,ACTUAL,2023-07-03,2023-07-03,ACTUAL,2023-07-03,,INTERVENTIONAL,,,"Pharmacokinetic, Safety and Immunogenicity Study of CMAB015 and Cosentyx in Healthy Volunteers","Phase I Comparison of Pharmacokinetics, Safety, and Immunogenicity of CMAB015 Injection and Cosentyx in a Randomized, Double-blind, Parallel Controlled, Single-dose Study in Healthy Chinese Male Subjects",COMPLETED,,PHASE1,130.0,ACTUAL,"Taizhou Mabtech Pharmaceutical Co.,Ltd",,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,INDUSTRY,,,,,,,2023,1.0
NCT04648826,,2020-12-01,,,2021-12-16,2020-12-01,2020-12-02,ACTUAL,,,,,,,2021-12-16,2021-12-17,ACTUAL,2021-12-14,ACTUAL,2021-12-14,2021-12,2021-12-31,2021-12-14,ACTUAL,2021-12-14,2021-12-14,ACTUAL,2021-12-14,,INTERVENTIONAL,,,"Aerosolized Azacytidine as Epigenetic Priming for Bintrafusp Alfa-Mediated Immune Checkpoint Blockade in Patients With Unresectable Pulmonary Metastases From Sarcomas, Germ Cell Tumors, or Epithelial Malignancies","Phase I/II Evaluation of Aerosolized Azacytidine as Epigenetic Priming for Bintrafusp Alfa-Mediated Immune Checkpoint Blockade in Patients With Unresectable Pulmonary Metastases From Sarcomas, Germ Cell Tumors, or Epithelial Malignancies",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,"Due to notification from EMD Serono, for Bintrafusp alfa (M7824) regarding an observed increase in the frequently of early progression and death.",f,,,,,t,f,,,,,,,,,,,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,NIH,,,,,,,2021,0.0
NCT02037035,,2013-11-19,,,2021-09-07,2014-01-14,2014-01-15,ESTIMATED,,,,,,,2021-09-07,2021-09-08,ACTUAL,2013-07,,2013-07-31,2021-09,2021-09-30,2021-06,ACTUAL,2021-06-30,2021-06,ACTUAL,2021-06-30,,INTERVENTIONAL,,,Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling,Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling,COMPLETED,,EARLY_PHASE1,36.0,ACTUAL,Yale University,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,OTHER,,,,,,,2021,1.0
NCT02737748,,2016-03-28,2023-05-05,,2023-07-26,2016-04-10,2016-04-14,ESTIMATED,2023-07-26,2023-07-28,ACTUAL,,,,2023-07-26,2023-07-28,ACTUAL,2017-07-06,ACTUAL,2017-07-06,2023-06,2023-06-30,2021-05-07,ACTUAL,2021-05-07,2021-05-07,ACTUAL,2021-05-07,,INTERVENTIONAL,,\[Not Specified\],TWB-103 for Adult Patients With Split-Thickness Skin Graft Donor Site Wounds,A Phase I/II Study to Evaluate the Safety and Efficacy of TWB-103 in Adult Patients With Split-Thickness Skin Graft Donor Site Wounds (DSW),COMPLETED,,PHASE1/PHASE2,48.0,ACTUAL,"Transwell Biotech Co., Ltd.",Some cases that healing observed by 1st evaluator could not be confirmed due to the lack of following visits. These are considered as flaws of protocol design.,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,INDUSTRY,,,,,,,2021,1.0
NCT03809988,,2019-01-15,,,2023-09-06,2019-01-16,2019-01-18,ACTUAL,,,,,,,2023-09-06,2023-09-07,ACTUAL,2019-04-05,ACTUAL,2019-04-05,2023-09,2023-09-30,2022-11-30,ACTUAL,2022-11-30,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,PALMIRA,,PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA),"International,Multicenter,Randomized,Open-label, Phase II to Evaluate the Efficacy and Safety of Continuation of Palbociclib+2nd Line Endocrine Therapy in HR+/HER2- ABC Patients Who Had Clinical Benefit During 1st Line Palbociclib.",COMPLETED,,PHASE2,198.0,ACTUAL,MedSIR,,2.0,,,f,,,,,f,f,,,f,,,During recruitment period,Oncology department,,YES,"Study Leaflet V2_20190115 with study design, primary objetive, inclusion criteria and exclusion criteria",2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,OTHER,,,,,,,2022,0.0
NCT04092452,,2019-09-15,2022-12-24,,2023-05-19,2019-09-15,2019-09-17,ACTUAL,2023-05-19,2023-06-15,ACTUAL,,,,2023-05-19,2023-06-15,ACTUAL,2019-12-02,ACTUAL,2019-12-02,2023-05,2023-05-31,2022-01-10,ACTUAL,2022-01-10,2022-01-10,ACTUAL,2022-01-10,,INTERVENTIONAL,,All enrolled participants who received at least one dose of study treatment.,"A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa","A PHASE 2A, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 16-WEEK STUDY EVALUATING THE SAFETY AND EFFICACY OF PF-06650833, PF-06700841, AND PF-06826647 IN ADULTS WITH MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA",COMPLETED,,PHASE2,194.0,ACTUAL,Pfizer,,4.0,,,f,,,,,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,INDUSTRY,,,,,,,2022,1.0
NCT04436744,,2020-06-16,2022-11-21,2022-06-23,2023-01-09,2020-06-16,2020-06-18,ACTUAL,2023-01-09,2023-02-02,ACTUAL,2023-01-09,2023-02-02,ACTUAL,2023-01-09,2023-02-02,ACTUAL,2020-09-04,ACTUAL,2020-09-04,2023-01,2023-01-31,2021-11-24,ACTUAL,2021-11-24,2021-07-06,ACTUAL,2021-07-06,,INTERVENTIONAL,,Intent-to-Treat (ITT) population included all randomized participants.,"A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)","A Randomized, Multicenter, Open-Label, Two-Arm, Phase II, Neoadjuvant Study Evaluating the Efficacy, Safety, and Pharmacokinetics of GDC-9545 Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer",COMPLETED,,PHASE2,221.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).~For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,INDUSTRY,,,,,,,2021,1.0
NCT02906020,,2016-09-14,2021-12-16,,2022-05-03,2016-09-14,2016-09-19,ESTIMATED,2022-02-02,2022-02-28,ACTUAL,,,,2022-05-03,2022-05-24,ACTUAL,2016-12-15,ACTUAL,2016-12-15,2022-05,2022-05-31,2021-05-27,ACTUAL,2021-05-27,2020-12-18,ACTUAL,2020-12-18,,INTERVENTIONAL,MOVES-PD,Analysis was performed on all randomized unique participants (N=250) only.,"A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation","Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients With Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant",TERMINATED,,PHASE2,273.0,ACTUAL,Sanofi,This study did not achieve its primary or secondary endpoints at the time of the analysis of the double-blind 52-week treatment period of Part 2 and was terminated early.,2.0,,"The topline results of the 52-week double-blind placebo-controlled period were analyzed. The study did not meet the primary or secondary endpoints. Based on these results, the decision was made to halt the long-term follow-up period of the study",f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,INDUSTRY,,,,,,,2021,0.0
NCT02693093,,2016-02-12,,,2022-12-14,2016-02-22,2016-02-26,ESTIMATED,,,,,,,2022-12-14,2022-12-16,ACTUAL,2016-02-24,ACTUAL,2016-02-24,2022-12,2022-12-31,2021-12-30,ACTUAL,2021-12-30,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,Tactic,,A Dose Ranging Study Evaluating Efficacy and Safety of NI-03,"A Phase 1, Single Dose PK and Safety Study With NI-03 Followed by a Phase 2, Randomized, Double-Blind, Parallel-Group Dose-Ranging Study to Evaluate the Safety and Efficacy of NI-03 When Compared to Placebo in Subjects With Chronic Pancreatitis",COMPLETED,,PHASE1/PHASE2,264.0,ACTUAL,"Kangen Pharmaceuticals, Inc",,4.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,INDUSTRY,,,,,,,2021,0.0
NCT04688931,,2020-07-21,2024-05-07,,2024-05-07,2020-12-29,2020-12-30,ACTUAL,2024-05-07,2024-06-06,ACTUAL,,,,2024-05-07,2024-06-06,ACTUAL,2021-02-19,ACTUAL,2021-02-19,2024-05,2024-05-31,2023-03-17,ACTUAL,2023-03-17,2023-03-17,ACTUAL,2023-03-17,,INTERVENTIONAL,ATLAS,,A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer,"A Randomized, Controlled, Open-Label Study of the Efficacy, Durability, and Safety of UGN-102 With or Without TURBT in Patients With Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)",TERMINATED,,PHASE3,282.0,ACTUAL,UroGen Pharma Ltd.,,2.0,,Alternate approach pursued,f,,,,,t,f,,,,,,,,,,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,INDUSTRY,,,,,,,2023,0.0
NCT04791423,,2021-02-22,,,2023-03-28,2021-03-09,2021-03-10,ACTUAL,,,,,,,2023-03-28,2023-03-29,ACTUAL,2021-03-15,ACTUAL,2021-03-15,2022-05,2022-05-31,2022-05-13,ACTUAL,2022-05-13,2021-06-04,ACTUAL,2021-06-04,,INTERVENTIONAL,COVITAR,,Study of GRAd-COV2 for the Prevention of COVID-19 in Adults,"A Phase II/III, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of GRAd-COV2 Vaccine in Adults Aged 18 Years and Older",COMPLETED,,PHASE2/PHASE3,10300.0,ACTUAL,ReiThera Srl,,3.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,INDUSTRY,,,,,,,2022,1.0
NCT05678283,,2022-12-23,,,2024-04-16,2022-12-23,2023-01-10,ACTUAL,,,,,,,2024-04-16,2024-04-17,ACTUAL,2023-01-09,ESTIMATED,2023-01-09,2024-04,2024-04-30,2024-04-29,ESTIMATED,2024-04-29,2024-04-29,ESTIMATED,2024-04-29,,INTERVENTIONAL,,,"A Study of Absorption, Metabolism, and Elimination CC-90010 in Participants With Advanced Solid Tumors","A Phase 1, 2-Part, Open-label Study to Determine the Absorption, Metabolism, and Elimination of [14C]CC-90010 in Participants With Advanced Solid Tumors",WITHDRAWN,,PHASE1,0.0,ACTUAL,Bristol-Myers Squibb,,2.0,,Business Objectives have changed.,f,,,,f,t,f,,,,,,,,,NO,"BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html.",2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,INDUSTRY,,,,,,,2024,0.0
NCT03177720,,2017-05-30,,,2021-08-31,2017-06-02,2017-06-06,ACTUAL,,,,,,,2021-08-31,2021-09-01,ACTUAL,2016-05-29,ACTUAL,2016-05-29,2021-08,2021-08-31,2021-07-31,ACTUAL,2021-07-31,2021-07-31,ACTUAL,2021-07-31,,INTERVENTIONAL,,,Evaluation of Innovative Tools in Development of Antibiotics,Determination of Single-dose Intrapulmonary Pharmacokinetics of Ciprofloxacin and Imipenem in Healthy Subjects and Intubated Patients Suffering From Pneumonia Using Bronchoalveolar Lavage,COMPLETED,,PHASE1,10.0,ACTUAL,Medical University of Vienna,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,OTHER,,,,,,,2021,1.0
NCT05282121,,2022-03-14,,,2024-07-23,2022-03-14,2022-03-16,ACTUAL,,,,,,,2024-07-23,2024-07-24,ACTUAL,2022-05-26,ACTUAL,2022-05-26,2024-07,2024-07-31,2024-06-17,ACTUAL,2024-06-17,2024-04-23,ACTUAL,2024-04-23,,INTERVENTIONAL,,,A Study to Test Whether BI 685509 Alone or in Combination With Empagliflozin Helps People With Liver Cirrhosis Caused by Viral Hepatitis or Non-alcoholic Steatohepatitis (NASH) Who Have High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver),"Randomised, Open-label and Parallel Group Trial to Investigate the Effects of Oral BI 685509 Alone or in Combination With Empagliflozin on Portal Hypertension After 8 Weeks Treatment in Patients With Clinically Significant Portal Hypertension (CSPH) in Compensated Cirrhosis",TERMINATED,,PHASE2,90.0,ACTUAL,Boehringer Ingelheim,,4.0,,Company decision,f,,,,t,t,f,,,,,,"After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'.~For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.",https://www.mystudywindow.com/msw/datasharing,YES,"Once the criteria in section Time frame are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.",2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,INDUSTRY,,,,,,,2024,0.0
NCT05256134,,2022-01-25,2024-03-08,,2024-06-17,2022-02-16,2022-02-25,ACTUAL,2024-06-17,2024-07-09,ACTUAL,,,,2024-06-17,2024-07-09,ACTUAL,2022-04-19,ACTUAL,2022-04-19,2024-06,2024-06-30,2023-03-13,ACTUAL,2023-03-13,2023-03-13,ACTUAL,2023-03-13,,INTERVENTIONAL,SKYLINE,Intent-to-treat (ITT) Population included all participants randomly assigned to study treatment. Participants were grouped into the two arms (placebo or gantenerumab) according to the treatment assigned at randomization.,A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD),"A Phase III, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease",TERMINATED,,PHASE3,25.0,ACTUAL,Hoffmann-La Roche,"SKYLINE study was terminated early \& limited data could be collected \& analyzed. Hence, no conclusions can be made on effectiveness of gantenerumab in treatment of people at risk for or at earliest stages of AD.",2.0,,Decision to terminate development of gantenerumab for treatment of people at risk for or at earliest stages of Alzheimer disease (AD) following results of a pre-planned analysis of safety \& efficacy of gantenerumab in Graduate I\&II (WN29922/WN39658).,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,INDUSTRY,,,,,,,2023,0.0
NCT03151746,,2017-04-19,2022-06-28,,2022-07-18,2017-05-11,2017-05-12,ACTUAL,2022-07-18,2022-07-21,ACTUAL,,,,2022-07-18,2022-07-21,ACTUAL,2018-01-14,ACTUAL,2018-01-14,2022-07,2022-07-31,2021-12-02,ACTUAL,2021-12-02,2021-12-02,ACTUAL,2021-12-02,,INTERVENTIONAL,,,Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion,"Effect of Preoperative Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion: a Double Blind, Randomized, Placebo Controlled Trial",TERMINATED,,PHASE4,20.0,ACTUAL,Northwestern University,The limitation to this study is that enrollment was affected by COVID 19 protocols within the hospital enrollment. This is why the project was terminated early .,2.0,,Insufficient enrollment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,OTHER,,,,,,,2021,0.0
NCT04853992,,2021-04-20,2023-07-11,,2024-04-18,2021-04-20,2021-04-22,ACTUAL,2024-03-20,2024-03-21,ACTUAL,,,,2024-04-18,2024-04-22,ACTUAL,2021-05-10,ACTUAL,2021-05-10,2024-04,2024-04-30,2022-07-11,ACTUAL,2022-07-11,2022-07-08,ACTUAL,2022-07-08,,INTERVENTIONAL,,,Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria,Phase 2a Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria,COMPLETED,,PHASE2,20.0,ACTUAL,JW Pharmaceutical,,2.0,,,f,,,,f,f,f,,,,,,,De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.,https://www.leopharmatrials.com/en/for-professionals,YES,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,INDUSTRY,,,,,,,2022,1.0
NCT04679389,,2020-12-14,,,2024-01-26,2020-12-17,2020-12-22,ACTUAL,,,,,,,2024-01-26,2024-01-29,ACTUAL,2021-03-17,ACTUAL,2021-03-17,2024-01,2024-01-31,2024-01-24,ACTUAL,2024-01-24,2024-01-24,ACTUAL,2024-01-24,,INTERVENTIONAL,,,Acetazolamide Efficacy in Ataxia in PMM2-CDG,"A Randomized, Double-blind, Placebo-controlled Study Evaluating Acetazolamide Efficacy in Ataxia in PMM2-CDG",TERMINATED,,PHASE2/PHASE3,25.0,ACTUAL,Mayo Clinic,,2.0,,Lack of funding,f,,,,t,t,f,,,f,,,,,,NO,De-identified data may be shared amongst member of the consortium FCDGC and with the NIH.,2024-10-16 09:17:24.908599,2024-10-16 09:17:24.908599,OTHER,,,,,,,2024,0.0
NCT03003949,,2016-12-06,2021-03-02,,2021-03-02,2016-12-21,2016-12-28,ESTIMATED,2021-03-02,2021-03-26,ACTUAL,,,,2021-03-02,2021-03-26,ACTUAL,2017-01-24,ACTUAL,2017-01-24,2020-03,2020-03-31,2020-05-10,ACTUAL,2020-05-10,2020-05-10,ACTUAL,2020-05-10,,INTERVENTIONAL,Changes,,"The Menopause Transition: Estrogen Variability, Stress Reactivity and Mood","The Menopause Transition: Estrogen Variability, HPA Axis and Affective Symptoms",TERMINATED,,PHASE4,82.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,In-person visit restrictions due to COVID-19,f,,,,t,t,f,,,,,,,,,YES,The investigators will submit data to the Research Domain Criteria Database (RDoCdb) and/or the National Database for Clinical Trials Related to Mental Illness (NDCT). The investigators will work with RDoCdb and NDCT staff to define data structures for any data being collected as part of the study. Descriptive data will be submitted two times per year and provide supporting documentation as necessary for others to more fully understand the manner in which data were collected. The investigators will submit cumulative data each submission cycle and will review data for any personally identifiable information and ensure that data are loaded correctly. The investigators will share data within 4 months after submission and submit experimental data within 12 months after study completion. Study data for each publication will be created and submit a link to the RDoCdb study along with any publications so readers of articles can link back to the data used in RDoCdb and NDCT.,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,OTHER,,,,,,,2020,0.0
NCT04408599,,2020-05-19,2024-06-26,,2024-07-23,2020-05-26,2020-05-29,ACTUAL,2024-07-23,2024-07-25,ACTUAL,,,,2024-07-23,2024-07-25,ACTUAL,2020-06-10,ACTUAL,2020-06-10,2024-07,2024-07-31,2023-07-06,ACTUAL,2023-07-06,2023-07-06,ACTUAL,2023-07-06,,INTERVENTIONAL,,,A Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors,"A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors",TERMINATED,,PHASE1/PHASE2,46.0,ACTUAL,"NextCure, Inc.",,7.0,,"Upon completion of the Phase 1 portion of the NC410 monotherapy trial, NextCure focused efforts on a combination trial of NC410 in solid tumors.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,INDUSTRY,,,,,,,2023,0.0
NCT02878694,,2016-03-08,,,2020-11-23,2016-08-22,2016-08-25,ESTIMATED,,,,,,,2020-11-23,2020-11-25,ACTUAL,2019-11-14,ACTUAL,2019-11-14,2020-11,2020-11-30,2020-10-09,ACTUAL,2020-10-09,2020-10-09,ACTUAL,2020-10-09,,INTERVENTIONAL,TTT-PT-DOP,,Treatment of Ptosis to Muscular Dystrophy Oculopharyngeal by Myoblast Autologous Graft,Treatment of Ptosis to Muscular Dystrophy Oculopharyngeal by Myoblast Autologous Graft,TERMINATED,,PHASE2/PHASE3,1.0,ACTUAL,"University Hospital, Caen",,1.0,,insufficient recruitment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,OTHER,,,,,,,2020,0.0
NCT03792347,,2018-12-28,2020-08-10,,2023-11-20,2019-01-01,2019-01-03,ACTUAL,2023-11-20,2023-11-22,ACTUAL,,,,2023-11-20,2023-11-22,ACTUAL,2019-01-21,ACTUAL,2019-01-21,2023-11,2023-11-30,2020-06-17,ACTUAL,2020-06-17,2020-03-17,ACTUAL,2020-03-17,,INTERVENTIONAL,PALACE-1,,Preoperative Anti-PD-1 Antibody Combined With Chemoradiotherapy for Locally Advanced Squamous Cell Carcinoma of Esophagus,A Phase Ib Study of Pre-Operative Pembrolizumab + Chemoradiation in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma,COMPLETED,,PHASE1,20.0,ACTUAL,Ruijin Hospital,This was a single arm study. The sample size was small. Patients were highly selected and from a single center. These may strict the generalizability of the results.,1.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,OTHER,,,,,,,2020,1.0
NCT01988506,,2013-11-07,,,2021-07-19,2013-11-13,2013-11-20,ESTIMATED,,,,,,,2021-07-19,2021-07-20,ACTUAL,2014-01-06,ACTUAL,2014-01-06,2021-07,2021-07-31,2021-04-01,ACTUAL,2021-04-01,2019-10-16,ACTUAL,2019-10-16,,INTERVENTIONAL,TRANSREG,,Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases,Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach,COMPLETED,,PHASE2,81.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,1.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,OTHER,,,,,,,2021,1.0
NCT05329168,,2022-03-23,,,2022-06-27,2022-04-08,2022-04-14,ACTUAL,,,,,,,2022-06-27,2022-06-30,ACTUAL,2022-05-01,ESTIMATED,2022-05-01,2022-06,2022-06-30,2023-11-01,ESTIMATED,2023-11-01,2023-08-17,ESTIMATED,2023-08-17,,INTERVENTIONAL,ERASE,,ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis,"An Open-Label, Multiple-Ascending Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LSVT-1701 as an Add-on to Standard of Care Antibiotics for the Treatment of Complicated Methicillin-Sensitive and -Resistant Staphylococcus Aureus Bacteremia Including Left- and Right-sided Infective Endocarditis",WITHDRAWN,,PHASE2,0.0,ACTUAL,Lysovant,,1.0,,business decision before FPFV; not related to any safety concerns,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,INDUSTRY,,,,,,,2023,0.0
NCT00497952,,2007-07-06,,,2023-10-10,2007-07-06,2007-07-09,ESTIMATED,,,,,,,2023-10-10,2023-10-12,ACTUAL,2007-07,,2007-07-31,2023-10,2023-10-31,2024-12,ESTIMATED,2024-12-31,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Allogeneic Stem Cell Transplantation for the Treatment of Multiple Sclerosis,Allogeneic Stem Cell Transplantation for the Treatment of Multiple Sclerosis,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Talaris Therapeutics Inc.,,1.0,,all clinical development programs terminated by sponsor,t,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,INDUSTRY,,NCT02084121,NO_LONGER_AVAILABLE,,,,2024,0.0
NCT02706951,,2016-02-18,2019-09-13,2018-09-26,2024-01-03,2016-03-08,2016-03-11,ESTIMATED,2019-09-13,2019-10-07,ACTUAL,2018-09-26,2018-09-28,ACTUAL,2024-01-03,2024-01-30,ACTUAL,2016-03-23,ACTUAL,2016-03-23,2024-01,2024-01-31,2022-08-10,ACTUAL,2022-08-10,2017-10-02,ACTUAL,2017-10-02,,INTERVENTIONAL,,The Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.,A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY),"A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX",COMPLETED,,PHASE3,648.0,ACTUAL,AbbVie,,4.0,,,f,,,,t,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 23:18:13.077682,2024-10-15 23:18:13.077682,INDUSTRY,,,,,,,2022,1.0
NCT04455503,,2020-06-14,,,2024-02-19,2020-06-30,2020-07-02,ACTUAL,,,,,,,2024-02-19,2024-02-21,ACTUAL,2020-07-13,ACTUAL,2020-07-13,2024-02,2024-02-29,2023-03-28,ACTUAL,2023-03-28,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,,,Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1,"A Phase 1/2, Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1 After Complete Resection of Stage IIIB/IIIC/IIID or Stage IV Melanoma in Patients at High Risk for Recurrence",TERMINATED,,PHASE1/PHASE2,15.0,ACTUAL,Evaxion Biotech A/S,,3.0,,"Based on the promising interim results of study part 1, it was decided to further accelerate the development of the 2nd generation DNA plasmid immunotherapy. Therefore enrolment of patients was completed after study part 1",f,,,,t,f,f,,,,,,,,,,,2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,INDUSTRY,,,,,,,2023,0.0
NCT04815603,,2021-03-08,,,2022-04-29,2021-03-22,2021-03-25,ACTUAL,,,,,,,2022-04-29,2022-05-05,ACTUAL,2021-03-22,ACTUAL,2021-03-22,2022-04,2022-04-30,2022-04,ESTIMATED,2022-04-30,2022-04,ESTIMATED,2022-04-30,,INTERVENTIONAL,,,Study to Evaluate Efficacy and Safety of BGE-117 in the Treatment of Anemia of Aging,"A Phase 2a, 12-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of BGE-117 in the Treatment of Anemia of Aging",WITHDRAWN,,PHASE2,0.0,ACTUAL,"BioAge Labs, Inc.",,2.0,,The program priority for execution of this clinical trial changed prior to enrollment of the first patient. The study was not withdrawn due to any safety concerns.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,INDUSTRY,,,,,,,2022,0.0
NCT05013554,,2021-08-12,,,2024-02-07,2021-08-13,2021-08-19,ACTUAL,,,,,,,2024-02-07,2024-02-09,ACTUAL,2021-08-16,ACTUAL,2021-08-16,2024-02,2024-02-29,2024-01-15,ACTUAL,2024-01-15,2024-01-15,ACTUAL,2024-01-15,,INTERVENTIONAL,,,Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors,"A Phase 1/1b Open-label, First-in-human, Single Agent, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors.",TERMINATED,,PHASE1,44.0,ACTUAL,Sanofi,,5.0,,Sponsor's decision. Termination decision unrelated to safety profile,f,,,,f,t,f,,,f,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,INDUSTRY,,,,,,,2024,0.0
NCT03406715,,2018-01-16,2023-02-02,,2023-03-29,2018-01-16,2018-01-23,ACTUAL,2023-03-29,2023-03-30,ACTUAL,,,,2023-03-29,2023-03-30,ACTUAL,2018-03-15,ACTUAL,2018-03-15,2023-03,2023-03-31,2022-05-16,ACTUAL,2022-05-16,2022-03-23,ACTUAL,2022-03-23,,INTERVENTIONAL,,,Combination Immunotherapy-Ipilimumab-Nivolumab-Dendritic Cell p53 Vac - Patients With Small Cell Lung Cancer (SCLC),Combination Immunotherapy With Ipilimumab and Nivolumab Plus a Dendritic Cell Based p53 Vaccine (Ad.p53-DC) in Patients With Relapsed Small Cell Lung Cancer (SCLC),TERMINATED,,PHASE2,14.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,1.0,,Sponsor closed study,f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:17:24.908599,2024-10-16 09:17:24.908599,OTHER,,,,,,,2022,0.0
NCT04970719,,2021-07-20,,,2024-04-07,2021-07-20,2021-07-21,ACTUAL,,,,,,,2024-04-07,2024-04-09,ACTUAL,2021-07-10,ACTUAL,2021-07-10,2024-04,2024-04-30,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Baricitinib in Hospitalized Covid-19 Patients With Diabetes Mellitus,The Efficacy of Baricitinib Plus Remdesivir Compared to Dexamethasone Plus Remdesivir in Hospitalised COVID-19 Patients With Diabetes Mellitus,WITHDRAWN,,PHASE3,0.0,ACTUAL,"Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders",,2.0,,adequate cases were not available,f,,,,f,f,f,,,,,,relative to the time when summary data are published,all data will be available if required,,YES,all IPD that underlie results in a publication,2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,OTHER,,,,,,,2021,0.0
NCT05625347,,2022-11-01,,,2024-03-21,2022-11-21,2022-11-22,ACTUAL,,,,,,,2024-03-21,2024-03-22,ACTUAL,2023-03-11,ACTUAL,2023-03-11,2024-03,2024-03-31,2023-06-30,ACTUAL,2023-06-30,2023-06-30,ACTUAL,2023-06-30,,INTERVENTIONAL,,,Study to Compare the Pharmacokinetics and Pharmacodynamics of ASA Powder for Oral Inhalation With Non-enteric-coated Chewable Aspirin in Adult Subjects With Obstructive or Restrictive Pulmonary Function,"A Single-dose, Open-label, Multi-center, Randomized, 2-treatment Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Acetylsalicylic Acid Powder for Oral Inhalation With Non-enteric-coated Chewable Aspirin in Adult Subjects With Obstructive or Restrictive Pulmonary Function",TERMINATED,,PHASE1,4.0,ACTUAL,"Vectura, Inc.",,2.0,,"The pivotal study failed to meet the primary endpoint. Without a successful readout of the pivotal study, there was no longer a purpose for the supportive BORA-1A-C302 study.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,INDUSTRY,,,,,,,2023,0.0
NCT01738243,,2012-10-06,,,2021-09-27,2012-11-27,2012-11-30,ESTIMATED,,,,,,,2021-09-27,2021-10-04,ACTUAL,2013-12,,2013-12-31,2021-09,2021-09-30,2021-09,ACTUAL,2021-09-30,2021-09,ACTUAL,2021-09-30,,INTERVENTIONAL,HALR,,Hyaluronic Acid Gels for Upper Lid Retraction in Active Stage Thyroid Eye Disease,Phase IV Study of Hyaluronic Acid Gels for Upper Lid Retraction in Active Stage Thyroid Eye Disease,TERMINATED,,PHASE4,2.0,ACTUAL,"University of California, Los Angeles",,2.0,,recruitment challenges,f,,,,t,,,,,,,,,,,,,2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,OTHER,,,,,,,2021,0.0
NCT03364491,,2017-11-22,2022-11-16,,2023-02-16,2017-12-05,2017-12-06,ACTUAL,2022-12-21,2023-01-19,ACTUAL,,,,2023-02-16,2023-02-21,ACTUAL,2018-03-15,ACTUAL,2018-03-15,2023-02,2023-02-28,2021-10-29,ACTUAL,2021-10-29,2021-07-24,ACTUAL,2021-07-24,,INTERVENTIONAL,TXA,"Of 5529 participants, 4 were enrolled in the study for a second pregnancy in the tranexamic acid group and out of 5471 participants, 1 was enrolled for a second pregnancy in the placebo group. Only the first pregnancy was included in the analysis.",Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean,Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean Delivery: A Randomized Controlled Trial,COMPLETED,,PHASE3,11000.0,ACTUAL,The George Washington University Biostatistics Center,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,The dataset will be shared per NIH policy after the completion and publication of the main analyses. Data be will accessible through the NICHD Data and Specimen Hub.,2024-10-16 09:17:24.908599,2024-10-16 09:17:24.908599,OTHER,,,,,,,2021,1.0
NCT04088786,,2019-09-11,,,2022-05-05,2019-09-11,2019-09-13,ACTUAL,,,,,,,2022-05-05,2022-05-06,ACTUAL,2019-10-22,ACTUAL,2019-10-22,2022-05,2022-05-31,2022-04-14,ACTUAL,2022-04-14,2021-10-11,ACTUAL,2021-10-11,,INTERVENTIONAL,,,Phase I Trial HIPEC With Nal-irinotecan,Phase I Trial of Cytoreductive Surgery and Heated Intraperitoneal Chemotherapy With Nanoliposomal Irinotecan in Patients With Peritoneal Surface Malignancies,COMPLETED,,PHASE1,18.0,ACTUAL,Stony Brook University,,1.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,OTHER,,,,,,,2022,1.0
NCT03017508,,2017-01-09,2021-03-09,,2021-04-30,2017-01-09,2017-01-11,ESTIMATED,2021-04-30,2021-05-20,ACTUAL,,,,2021-04-30,2021-05-20,ACTUAL,2017-01,,2017-01-31,2021-04,2021-04-30,2021-01-29,ACTUAL,2021-01-29,2019-12,ACTUAL,2019-12-31,,INTERVENTIONAL,,,Acute Anxiolytic Effects of Riluzole on Subjects With Social Anxiety Disorder,"Double-Blind, Placebo-Controlled, Single-Dose Crossover Study Examining the Effects of Sublingual Riluzole (BHV-0223) on Public Speaking in Social Anxiety Disorder",COMPLETED,,PHASE2/PHASE3,22.0,ACTUAL,Yale University,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,OTHER,,,,,,,2021,1.0
NCT05413187,,2019-04-24,,,2022-06-07,2022-06-07,2022-06-09,ACTUAL,,,,,,,2022-06-07,2022-06-09,ACTUAL,2020-09-01,ESTIMATED,2020-09-01,2022-06,2022-06-30,2022-09-01,ESTIMATED,2022-09-01,2022-09-01,ESTIMATED,2022-09-01,,INTERVENTIONAL,,,A Trial to Assess the Efficacy and Safety of Medical Grade Cannabis in Children Diagnosed With Autism Spectrum Disorder,"A Double-Blind, Placebo Controlled, Randomized Trial to Assess the Efficacy and Safety of Medical Grade Cannabis (MGC) in Children Diagnosed With Autism Spectrum Disorder",WITHDRAWN,,PHASE2,0.0,ACTUAL,TO Pharmaceuticals,,2.0,,withdrawn due to COVID-19,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,INDUSTRY,,,,,,,2022,0.0
NCT03529929,,2018-04-20,,,2020-03-09,2018-05-07,2018-05-18,ACTUAL,,,,,,,2020-03-09,2020-03-11,ACTUAL,2019-06-01,ESTIMATED,2019-06-01,2020-03,2020-03-31,2020-12-01,ESTIMATED,2020-12-01,2020-05-01,ESTIMATED,2020-05-01,,INTERVENTIONAL,,,Glucocorticoid Inflammation Paradox in Human Skeletal Muscle,Glucocorticoid Inflammation Paradox in Human Skeletal Muscle,WITHDRAWN,,PHASE3,0.0,ACTUAL,Texas A&M University,,1.0,,withdrawn,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 09:17:24.908599,2024-10-16 09:17:24.908599,OTHER,,,,,,,2020,0.0
NCT02447991,,2015-03-18,2021-07-14,,2021-10-06,2015-05-14,2015-05-19,ESTIMATED,2021-10-06,2021-11-04,ACTUAL,,,,2021-10-06,2021-11-04,ACTUAL,2014-12,ACTUAL,2014-12-31,2019-10,2019-10-31,2020-07-31,ACTUAL,2020-07-31,2020-07-31,ACTUAL,2020-07-31,,INTERVENTIONAL,,,Rizatriptan for Episodic Dizziness in Vestibular Migraine,A Phase II/III Trial on Rizatriptan for Vestibular Migraine,COMPLETED,,PHASE2/PHASE3,223.0,ACTUAL,"University of California, Los Angeles",,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,OTHER,,,,,,,2020,1.0
NCT04052061,,2019-08-07,,,2022-05-09,2019-08-08,2019-08-09,ACTUAL,,,,,,,2022-05-09,2022-05-13,ACTUAL,2019-09-16,ESTIMATED,2019-09-16,2022-05,2022-05-31,2023-12-18,ESTIMATED,2023-12-18,2023-09-18,ESTIMATED,2023-09-18,,INTERVENTIONAL,,,QUILT-3.061: CD19 t-haNK in Subjects With Diffuse Large B-Cell Lymphoma,"Open-Label, Phase 1 Study of CD19 t-haNK In Subjects With Diffuse Large B-Cell Lymphoma Who Have Received 2 Or More Lines of Therapy And Are Ineligible For Transplant",WITHDRAWN,,PHASE1,0.0,ACTUAL,"ImmunityBio, Inc.",,1.0,,Trial not initiated,,,,,f,t,f,,,,,,,,,NO,,2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,INDUSTRY,,,,,,,2023,0.0
NCT04059458,,2019-08-06,,,2023-11-27,2019-08-15,2019-08-16,ACTUAL,,,,,,,2023-11-27,2023-11-30,ACTUAL,2019-10-15,ACTUAL,2019-10-15,2023-11,2023-11-30,2023-11-27,ACTUAL,2023-11-27,2023-11-27,ACTUAL,2023-11-27,,INTERVENTIONAL,FURC-III-REGEN,,Mandibular Furcation III Regeneration (FURC-III-REGEN),"Biphasic Calcium Phosphate and a Collagen Membrane or Biphasic Calcium Phosphate and Enamel Matrix Proteins, in the Regenerative Treatment of Furcation Grade III Defects",TERMINATED,,PHASE4,5.0,ACTUAL,University of Oslo,,2.0,,Recruitment problem,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,OTHER,,,,,,,2023,0.0
NCT03861403,,2019-02-26,,,2023-11-27,2019-02-27,2019-03-04,ACTUAL,,,,,,,2023-11-27,2023-11-30,ACTUAL,2019-05-20,ACTUAL,2019-05-20,2023-11,2023-11-30,2020-07-14,ACTUAL,2020-07-14,2020-07-14,ACTUAL,2020-07-14,,INTERVENTIONAL,,,A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors,A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors,TERMINATED,,PHASE1,10.0,ACTUAL,"Leap Therapeutics, Inc.",,5.0,,Product development discontinued unrelated to safety.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,INDUSTRY,,,,,,,2020,0.0
NCT03229538,,2017-07-05,2023-03-22,,2023-05-08,2017-07-24,2017-07-25,ACTUAL,2023-05-08,2023-05-10,ACTUAL,,,,2023-05-08,2023-05-10,ACTUAL,2017-10-18,ACTUAL,2017-10-18,2023-05,2023-05-31,2022-03-31,ACTUAL,2022-03-31,2022-03-31,ACTUAL,2022-03-31,,INTERVENTIONAL,STRESS,,STeroids to REduce Systemic Inflammation After Infant Heart Surgery,STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS),COMPLETED,,PHASE3,1263.0,ACTUAL,Duke University,,2.0,,,,,,,t,t,f,,,,,,,,,YES,"The investigators will disseminate findings through publications, national presentations, participation in the CTSA Consortium, the CTSA website and via the existing infrastructure of the Society of Thoracic Surgeons Congenital Heart Surgery Database. Data collection supported by CTSA funds will follow the principles outlined in the Final NIH Statement on Sharing Research Data. Participating institutions will honor the principle that data sharing is critical for expeditious translation of research findings to the improvement of human health. The investigators abide strictly by the provisions of the Health Insurance Portability and Accountability Act (HIPAA). The investigators will continue to use traditional venues for data sharing, such as publications in leading scientific journals and deposit all applicable NIH-funded research results to PubMed Central in compliance with the NIH's Public Access Policy.",2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,OTHER,,,,,,,2022,1.0
NCT03111212,,2017-04-06,,,2021-12-08,2017-04-06,2017-04-12,ACTUAL,,,,,,,2021-12-08,2021-12-30,ACTUAL,2019-06-25,ACTUAL,2019-06-25,2021-06,2021-06-30,2021-08-14,ACTUAL,2021-08-14,2021-05-14,ACTUAL,2021-05-14,,INTERVENTIONAL,ThIlo,,Iloprost in Acute Respiratory Distress Syndrome,Therapeutic Iloprost for the Treatment of Acute Respiratory Distress Syndrome (ARDS) (the ThIlo-Trial),COMPLETED,,PHASE3,150.0,ACTUAL,University Hospital Tuebingen,,2.0,,,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,OTHER,,,,,,,2021,0.0
NCT01470612,,2011-10-21,2021-08-03,,2021-09-16,2011-11-09,2011-11-11,ESTIMATED,2021-09-16,2021-09-17,ACTUAL,,,,2021-09-16,2021-09-17,ACTUAL,2012-10-01,ACTUAL,2012-10-01,2021-09,2021-09-30,2020-08-06,ACTUAL,2020-08-06,2020-08-06,ACTUAL,2020-08-06,,INTERVENTIONAL,OCTAVE,Full analysis set (FAS) included all participants who received at least 1 dose of study medication in this study.,"Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis","A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS",COMPLETED,,PHASE3,944.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 18:40:25.63614,2024-10-16 18:40:25.63614,INDUSTRY,,,,,,,2020,1.0
NCT04665375,,2020-11-24,,,2024-05-07,2020-12-10,2020-12-11,ACTUAL,,,,,,,2024-05-07,2024-05-09,ACTUAL,2021-04-26,ACTUAL,2021-04-26,2024-05,2024-05-31,2024-03-31,ACTUAL,2024-03-31,2024-03-31,ACTUAL,2024-03-31,,INTERVENTIONAL,DeLiTE,,Can INSTI-associated Weight Gain be Halted or Reversed With a Switch to Doravirine/Lamivudine/Tenofovir DF?,Can the Weight Gain Associated With Use of Integrase Strand Inhibitors be Halted or Reversed With a Switch to Doravirine/Lamivudine/Tenofovir DF in Patients Living With HIV? (DeLiTE),TERMINATED,,PHASE4,4.0,ACTUAL,"University Health Network, Toronto",,1.0,,enrollment futility,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,OTHER,,,,,,,2024,0.0
NCT03017547,,2017-01-09,,,2019-03-12,2017-01-09,2017-01-11,ESTIMATED,,,,,,,2019-03-12,2019-03-14,ACTUAL,2019-06,ESTIMATED,2019-06-30,2018-05,2018-05-31,2020-06,ESTIMATED,2020-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Preliminary Efficacy Study of IC14 in Acute Respiratory Distress Syndrome",WITHDRAWN,,PHASE2,0.0,ACTUAL,Implicit Bioscience,,2.0,,seeking funding,f,,,,t,t,f,,,,,,,,,,,2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,INDUSTRY,,,,,,,2020,0.0
NCT05438498,,2022-06-17,,,2023-09-06,2022-06-24,2022-06-30,ACTUAL,,,,,,,2023-09-06,2023-09-08,ACTUAL,2022-06-03,ACTUAL,2022-06-03,2023-09,2023-09-30,2023-06-30,ACTUAL,2023-06-30,2023-04-29,ACTUAL,2023-04-29,,INTERVENTIONAL,,,Real World Evaluation of the Effectiveness of AZD7442 for Prevention of SARS-CoV-2,Real World Evaluation of the Effectiveness of AZD7442 for Prevention of SARS-CoV-2 Infection in Immuno-Suppressed Cancer Patients,TERMINATED,,PHASE3,550.0,ACTUAL,"MediMergent, LLC",,1.0,,FDA withdrew EUA for AZD7442,f,,,,t,t,f,,,,,,,,,,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,INDUSTRY,,,,,,,2023,0.0
NCT03809039,,2019-01-16,2021-06-02,,2023-05-12,2019-01-16,2019-01-18,ACTUAL,2021-08-25,2021-09-21,ACTUAL,,,,2023-05-12,2023-05-15,ACTUAL,2019-01-15,ACTUAL,2019-01-15,2023-05,2023-05-31,2020-07-01,ACTUAL,2020-07-01,2019-07-01,ACTUAL,2019-07-01,,INTERVENTIONAL,,The analysis population is the subjects of Part 1 and Part 3 since the subjects of part 2 were selected from part 1.,"A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects","A Randomised, Double-Blind, Placebo-Controlled Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of MT-6345 in Healthy Subjects",TERMINATED,,PHASE1,52.0,ACTUAL,Mitsubishi Tanabe Pharma America Inc.,,2.0,,Preclinical finding,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,INDUSTRY,,,,,,,2020,0.0
NCT01950234,,2013-08-30,,,2023-05-12,2013-09-20,2013-09-25,ESTIMATED,,,,,,,2023-05-12,2023-05-16,ACTUAL,2014-04-17,ACTUAL,2014-04-17,2023-05,2023-05-31,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,ACTH in Progressive Forms of MS,Treatment of Progressive Forms of Multiple Sclerosis With Pulsed ACTH (Acthar Gel),TERMINATED,,PHASE2,59.0,ACTUAL,University of Minnesota,,2.0,,The funding source discontinued financial support for the study.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,OTHER,,,,,,,2022,0.0
NCT04434001,,2020-06-12,,,2021-10-28,2020-06-12,2020-06-16,ACTUAL,,,,,,,2021-10-28,2021-11-03,ACTUAL,2020-02-27,ACTUAL,2020-02-27,2021-10,2021-10-31,2021-06-30,ACTUAL,2021-06-30,2021-05-31,ACTUAL,2021-05-31,,INTERVENTIONAL,ZEPLAST-PED,,ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery,ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery Randomized Controlled Pilot Phase II Study,TERMINATED,,PHASE2,40.0,ACTUAL,IRCCS Policlinico S. Donato,,2.0,,The study encountered unexpected difficulties in enrolling patients due to requirements for the Informed Consent. 60% of our patients comes from abroad with only one accompanying parent. The rules of our EC require both parents to sign the consent.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,OTHER,,,,,,,2021,0.0
NCT03334253,,2017-11-02,2023-01-27,,2023-08-22,2017-11-06,2017-11-07,ACTUAL,2023-04-17,2023-05-11,ACTUAL,,,,2023-08-22,2023-09-05,ACTUAL,2018-06-01,ACTUAL,2018-06-01,2023-08,2023-08-31,2022-09-12,ACTUAL,2022-09-12,2022-04-15,ACTUAL,2022-04-15,,INTERVENTIONAL,MTS1,,Low-Dose Atropine for Treatment of Myopia,Low-Dose Atropine for Treatment of Myopia (Myopia Treatment Study),COMPLETED,,PHASE3,200.0,ACTUAL,Jaeb Center for Health Research,,2.0,,,,,,,t,t,f,,,f,,,"After completion of the protocol and publication of the primary manuscript, the data will be made available for the duration of the grant and any future grants.",Users accessing the data must enter an email address.,,YES,"In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.",2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,OTHER,,,,,,,2022,0.0
NCT02502747,,2015-06-29,,,2022-03-28,2015-07-16,2015-07-20,ESTIMATED,,,,,,,2022-03-28,2022-03-29,ACTUAL,2020-01,ESTIMATED,2020-01-31,2022-03,2022-03-31,2021-12,ESTIMATED,2021-12-31,2021-10,ESTIMATED,2021-10-31,,INTERVENTIONAL,RIGENERA,,RIGENERA 2.0 Trial,RIGENERA 2.0 (Recupero Dall'Infarto Miocardico Con G-CSF E Nuovi Esempi di Rigenerazione Avanzata) Project: The Combined Effect of Subcutaneous Granulocyte - Colony Stimulating Factor and Myocardial Contrast Echocardiography With Intravenous Infusion of Sulphur Hexafluoride on Post-infarction Left Ventricular Function,WITHDRAWN,,PHASE2,0.0,ACTUAL,Catholic University of the Sacred Heart,,2.0,,slow enrolment,f,,,,t,f,f,,,,,,,,,,,2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,OTHER,,,,,,,2021,0.0
NCT05435053,,2022-06-22,,,2023-09-13,2022-06-27,2022-06-28,ACTUAL,,,,,,,2023-09-13,2023-09-15,ACTUAL,2022-09-08,ACTUAL,2022-09-08,2023-09,2023-09-30,2023-08-30,ACTUAL,2023-08-30,2023-08-30,ACTUAL,2023-08-30,,INTERVENTIONAL,CHECKPOINT,,Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer,"Irreversible Electroporation in Combination With Immune Checkpoint Inhibition, in Patients With Metastatic Pancreatic Cancer - A Prospective, Phase 2 Study",TERMINATED,,PHASE2,9.0,ACTUAL,Zealand University Hospital,,1.0,,"The study was terminated on the basis on an evaluation of the safety and efficacy of the 9 included patients of which 2 of the patients were excluded before receiving any study treatments, thus 7 patients were treated in the study.",f,,,,t,t,t,,,t,,,,,,NO,,2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,OTHER,,,,,,,2023,0.0
NCT04583969,,2020-10-09,2023-04-13,,2023-06-01,2020-10-09,2020-10-12,ACTUAL,2023-06-01,2023-06-05,ACTUAL,,,,2023-06-01,2023-06-05,ACTUAL,2020-10-23,ACTUAL,2020-10-23,2022-01,2022-01-31,2022-04-22,ACTUAL,2022-04-22,2022-04-22,ACTUAL,2022-04-22,,INTERVENTIONAL,,The intention-to-treat (ITT) population includes all randomized participants.,ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19,A Multicenter Platform Trial of Putative Therapeutics for the Treatment of COVID-19 in Hospitalized Adults,COMPLETED,,PHASE2,527.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-16 09:17:24.908599,2024-10-16 09:17:24.908599,NIH,,,,,,,2022,1.0
NCT04242147,,2020-01-23,,,2024-01-11,2020-01-23,2020-01-27,ACTUAL,,,,,,,2024-01-11,2024-01-12,ACTUAL,2023-03-06,ACTUAL,2023-03-06,2024-01,2024-01-31,2023-12-01,ACTUAL,2023-12-01,2023-12-01,ACTUAL,2023-12-01,,INTERVENTIONAL,,,"A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 (SAR445710) in Subjects With Metastatic or Locally Advanced Solid Tumors","A Phase 1, Open-label, Multiple-ascending Dose Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 (SAR445710) in Subjects With Metastatic or Locally Advanced Solid Tumors",TERMINATED,,PHASE1,45.0,ACTUAL,Sanofi,,3.0,,Sponsor's decision.,f,,,,f,t,f,,,f,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-14 21:57:34.138868,2024-10-14 21:57:34.138868,INDUSTRY,,,,,,,2023,0.0
NCT05323019,,2022-03-24,,,2023-03-22,2022-04-04,2022-04-12,ACTUAL,,,,,,,2023-03-22,2023-03-24,ACTUAL,2022-10-13,ACTUAL,2022-10-13,2023-03,2023-03-31,2023-02-01,ACTUAL,2023-02-01,2023-02-01,ACTUAL,2023-02-01,,INTERVENTIONAL,ZYL-730-01,,Repeated Intranasal Esketamine Plus Almond Therapy in Patients With Treatment Resistant Depression,"A Randomized, Controlled, Single-Blind, Phase 2 Study in Treatment Resistant Major Depressive Disorder Patients Receiving Intranasal Esketamine (SpravatoTM) Over a 28-day Period Comparing Addition of Almond TherapyTM With Treatment-as-Usual",TERMINATED,,PHASE2,6.0,ACTUAL,Zylorion Health,,2.0,,Funding,f,,,,t,f,f,,,,,,Throughout the study.,Involved in data collection,,YES,IPD will be available to other members of the research team including Dr. Craig Buchholz,2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,INDUSTRY,,,,,,,2023,0.0
NCT04530604,,2020-08-25,2022-06-28,,2022-06-28,2020-08-26,2020-08-28,ACTUAL,2022-06-28,2023-05-09,ACTUAL,,,,2022-06-28,2023-05-09,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2022-06,2022-06-30,2021-04-09,ACTUAL,2021-04-09,2021-03-26,ACTUAL,2021-03-26,,INTERVENTIONAL,,,Defibrotide Therapy for SARS-CoV2 (COVID-19) Acute Respiratory Distress Syndrome (ARDS),Defibrotide Therapy for SARS-CoV2 Acute Respiratory Distress Syndrome (ARDS),COMPLETED,,PHASE1,13.0,ACTUAL,University of Michigan,,1.0,,,,,,,,t,f,,,,,,,,,NO,,2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,OTHER,,,,,,,2021,1.0
NCT03740243,,2018-10-15,,,2020-03-22,2018-11-09,2018-11-14,ACTUAL,,,,,,,2020-03-22,2020-03-24,ACTUAL,2018-11-30,ACTUAL,2018-11-30,2020-03,2020-03-31,2020-03-22,ACTUAL,2020-03-22,2020-03-22,ACTUAL,2020-03-22,,INTERVENTIONAL,,,Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology,Comparison of Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology,WITHDRAWN,,PHASE4,0.0,ACTUAL,Stony Brook University,,2.0,,No enrollment,f,,,,t,t,f,,,t,,,,,,NO,"In regards to the participants and neonates' health information, care will be taken to ensure privacy. All data and specimens will be coded with a case number and de-identified, and exported to a REDcap application system (secure data file approved by Institutional Review Board). The REDcap application data will be kept on the department's secure, shared institutional, server space.",2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,OTHER,,,,,,,2020,0.0
NCT03485053,,2018-03-20,,,2021-10-21,2018-03-26,2018-04-02,ACTUAL,,,,,,,2021-10-21,2021-10-28,ACTUAL,2018-11-29,ACTUAL,2018-11-29,2021-10,2021-10-31,2021-08-31,ACTUAL,2021-08-31,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,,,A Single Ascending Study of IOP Injection in Patients With Iron Deficient Anemia,"2 Part, Phase II Study of Intravenous, Single Ascending Dose Administrations of IOP Injection in Patients With Iron Deficient Anemia",TERMINATED,,PHASE2,49.0,ACTUAL,MegaPro Biomedical Co. Ltd.,,1.0,,Sponsor terminate the trial and will conduct a phase 2b clinical trial further,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,INDUSTRY,,,,,,,2021,0.0
NCT04650399,,2020-11-25,,,2024-05-02,2020-12-01,2020-12-02,ACTUAL,,,,,,,2024-05-02,2024-05-03,ACTUAL,2022-01-31,ACTUAL,2022-01-31,2024-05,2024-05-31,2024-02-15,ACTUAL,2024-02-15,2023-02-13,ACTUAL,2023-02-13,,INTERVENTIONAL,,,A Multicenter Study to Evaluate Safety and Immunogenicity of a Live-attenuated Chikungunya Vaccine in Adolescents,"A Multicenter, Randomized, Controlled, Double Blinded Pivotal Study to Evaluate Safety and Immunogenicity of a Live-attenuated Chikungunya Virus Vaccine Candidate (VLA1553) in Adolescents Aged 12 Years to <18 Years",COMPLETED,,PHASE3,750.0,ACTUAL,Butantan Institute,,2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,OTHER_GOV,,,,,,,2024,1.0
NCT05295394,,2019-10-25,,,2022-04-05,2022-03-16,2022-03-25,ACTUAL,,,,,,,2022-04-05,2022-04-12,ACTUAL,2019-05-22,ACTUAL,2019-05-22,2022-04,2022-04-30,2022-08-30,ESTIMATED,2022-08-30,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,PADDLE184V,,Dolutegravir-Lamivudine as Dual Therapy in naïve HIV-Infected Patients With Documented M184V Mutation:A Pilot Study,Dolutegravir-Lamivudine as Dual Therapy in naïve HIV-Infected Patients With Documented M184V Mutation:A Pilot Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,Fundación Huésped,,1.0,,"Low recruitment, We did not find participants with the M184V mutation , inclusion criteria , throughout 230 resistance tests carried out",f,,,,t,f,f,,,,,,3 month after last patient last visit,,,YES,to publish week 48 study results,2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,OTHER,,,,,,,2022,0.0
NCT04768010,,2021-02-19,,,2023-09-26,2021-02-19,2021-02-24,ACTUAL,,,,,,,2023-09-26,2023-09-28,ACTUAL,2023-08,ESTIMATED,2023-08-31,2023-09,2023-09-30,2023-09-18,ACTUAL,2023-09-18,2023-09-18,ACTUAL,2023-09-18,,INTERVENTIONAL,,,Misoprostol for Bloating and Distension,Misoprostol for the Management of Bloating and Gaseous Distension in Patients With Cirrhosis: an Open Label Trial,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Montefiore Medical Center,,1.0,,After significant delays study was never initiated. No participants enrolled,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,OTHER,,,,,,,2023,0.0
NCT04256733,,2019-09-24,2022-02-22,,2023-08-03,2020-02-04,2020-02-05,ACTUAL,2023-08-03,2024-03-04,ACTUAL,,,,2023-08-03,2024-03-04,ACTUAL,2019-05-01,ACTUAL,2019-05-01,2023-08,2023-08-31,2021-02-13,ACTUAL,2021-02-13,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,,,Cough Desensitization Therapy for Cough Hypersensitivity Syndrome,A Pilot Study of Cough Reflex Desensitization for the Treatment of Cough Hypersensitivity Syndrome,COMPLETED,,EARLY_PHASE1,19.0,ACTUAL,University of Montana,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,OTHER,,,,,,,2021,1.0
NCT05213143,,2021-12-05,,,2024-04-17,2022-01-16,2022-01-28,ACTUAL,,,,,,,2024-04-17,2024-04-19,ACTUAL,2021-12-30,ACTUAL,2021-12-30,2024-04,2024-04-30,2022-11-18,ACTUAL,2022-11-18,2022-11-18,ACTUAL,2022-11-18,,INTERVENTIONAL,,,The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine,"The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine: An Open-label, Single-arm And Multi-center Study for 16 Weeks",TERMINATED,,PHASE4,13.0,ACTUAL,"Sumitomo Pharma (Suzhou) Co., Ltd.",,1.0,,Company's business decision,f,,,,,t,f,,,t,,,,,,,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,INDUSTRY,,,,,,,2022,0.0
NCT05162365,,2021-12-12,,,2023-12-12,2021-12-16,2021-12-17,ACTUAL,,,,,,,2023-12-12,2023-12-18,ACTUAL,2022-01-06,ACTUAL,2022-01-06,2023-12,2023-12-31,2022-11-18,ACTUAL,2022-11-18,2022-06-29,ACTUAL,2022-06-29,,INTERVENTIONAL,,,"A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19","A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19",TERMINATED,,PHASE1/PHASE2,248.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,2.0,,The company decision that terminated the further develop of the molecule and had notified FDA about the termination as well.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,INDUSTRY,,,,,,,2022,0.0
NCT02735850,,2016-03-22,,,2017-05-22,2016-04-11,2016-04-13,ESTIMATED,,,,,,,2017-05-22,2017-05-23,ACTUAL,2015-12,ESTIMATED,2015-12-31,2016-04,2016-04-30,2021-06,ESTIMATED,2021-06-30,2021-02,ESTIMATED,2021-02-28,,INTERVENTIONAL,ImmunoSABR,,Combination of SABR and L19-IL2 in Patients With Stage IV Lung Cancer (ImmunoSABR),A Randomized Phase II Trial of the Combination of SBRT With L19-IL2 in Patients With Limited Metastatic Non-small Cell Lung Cancer (NSCLC),WITHDRAWN,,PHASE2,0.0,ACTUAL,Maastricht Radiation Oncology,,4.0,,"Not yet submitted, unclear timelines",f,,,,f,,,,,,,,,,,UNDECIDED,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,OTHER,,,,,,,2021,0.0
NCT03188666,,2017-06-13,2022-09-15,2020-09-15,2022-11-04,2017-06-13,2017-06-15,ACTUAL,2022-11-04,2022-12-02,ACTUAL,2022-11-04,2022-12-02,ACTUAL,2022-11-04,2022-12-02,ACTUAL,2018-02-26,ACTUAL,2018-02-26,2022-11,2022-11-30,2021-09-16,ACTUAL,2021-09-16,2019-09-16,ACTUAL,2019-09-16,,INTERVENTIONAL,LUMINA-1,The full analysis set (FAS) included all randomized participants and was based on the treatment allocated.,"A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva","A Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effects on Heterotopic Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva",COMPLETED,,PHASE2,44.0,ACTUAL,Regeneron Pharmaceuticals,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,INDUSTRY,,,,,,,2021,1.0
NCT03212807,,2017-07-07,,,2018-09-11,2017-07-07,2017-07-11,ACTUAL,,,,,,,2018-09-11,2018-09-13,ACTUAL,2017-08,ESTIMATED,2017-08-31,2018-09,2018-09-30,2023-08,ESTIMATED,2023-08-31,2021-02,ESTIMATED,2021-02-28,,INTERVENTIONAL,DuRIANS,,"Study Of Durvalumab and Lenalidomide In R/R EBV Associated DLBCL Subtypes, Primary CNS And Testicular DLBCL","Phase II Study Of Durvalumab In Combination With Lenalidomide In Relapsed/Refractory EBV Associated Subtypes Of DLBCL, Primary CNS Lymphoma And Primary Testicular DLBCL - DuRIANS (Durvalumab Revlimid In Aggressive NHL Subtypes)",WITHDRAWN,,PHASE2,0.0,ACTUAL,Singapore General Hospital,,1.0,,FDA Hold for Combination Studies using Imids and PD1/PDL1 Compounds,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 09:17:24.908599,2024-10-16 09:17:24.908599,OTHER,,,,,,,2023,0.0
NCT03386162,,2017-12-21,,,2022-11-22,2017-12-21,2017-12-29,ACTUAL,,,,,,,2022-11-22,2022-11-28,ACTUAL,2018-03-15,ACTUAL,2018-03-15,2022-11,2022-11-30,2022-11-18,ACTUAL,2022-11-18,2022-11-18,ACTUAL,2022-11-18,,INTERVENTIONAL,SAFIR-PI3K,,SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer,A Phase II Randomized Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy as Maintenance Therapy in Patients With PIK3CA Mutated Advanced Breast Cancer,TERMINATED,,PHASE2,31.0,ACTUAL,UNICANCER,,2.0,,Study was halted Prematurely for low recruitment.,f,,,,t,f,f,,,,,,,,,,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,OTHER,,,,,,,2022,0.0
NCT04891718,,2021-05-13,,,2022-07-05,2021-05-13,2021-05-18,ACTUAL,,,,,,,2022-07-05,2022-07-08,ACTUAL,2021-09-15,ACTUAL,2021-09-15,2022-07,2022-07-31,2022-06-05,ACTUAL,2022-06-05,2022-06-05,ACTUAL,2022-06-05,,INTERVENTIONAL,,,CIVO Intratumoural Microdosing of Anti-Cancer Therapies in Australia,A Phase 0 Master Protocol Using the CIVO® Platform to Evaluate Intratumoural Microdoses of Anti-Cancer Therapies in Patients With Solid Tumours,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Presage Biosciences,,1.0,,Termination by pharmaceutical sponsor,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,INDUSTRY,,,,,,,2022,0.0
NCT03783923,,2018-12-19,2022-03-01,2021-11-09,2022-05-31,2018-12-19,2018-12-21,ACTUAL,2022-05-31,2022-06-27,ACTUAL,2022-05-31,2022-06-27,ACTUAL,2022-05-31,2022-06-27,ACTUAL,2019-10-31,ACTUAL,2019-10-31,2022-05,2022-05-31,2021-01-01,ACTUAL,2021-01-01,2021-01-01,ACTUAL,2021-01-01,,INTERVENTIONAL,,Enrolled population included all informed-consented participants who met all inclusion and exclusion criteria.,A Study of Deflazacort (Emflaza®) in Participants With Limb-Girdle Muscular Dystrophy 2I (LGMD2I),A Multicenter Open-Label Study on the Safety and Efficacy of Deflazacort (Emflaza) in Subjects With Limb-Girdle Muscular Dystrophy 2I (LGMD2I),TERMINATED,,PHASE3,11.0,ACTUAL,PTC Therapeutics,The study was terminated early due to low enrollment and missing efficacy assessment data due to missed visits related to COVID-19.,1.0,,The study was terminated early due to low enrollment and missing efficacy assessment data due to missed visits related to COVID-19.,f,,,,f,t,f,,,t,,,,,,,,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,INDUSTRY,,,,,,,2021,0.0
NCT05561530,,2022-09-26,,,2024-03-12,2022-09-28,2022-09-30,ACTUAL,,,,,,,2024-03-12,2024-03-15,ACTUAL,2022-10-07,ACTUAL,2022-10-07,2024-03,2024-03-31,2023-06-15,ACTUAL,2023-06-15,2023-06-15,ACTUAL,2023-06-15,,INTERVENTIONAL,,,"A Study of ALG-125755 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single Doses in Healthy Volunteers, and Single and Multiple Doses in CHB Subjects","A Phase 1/1b, Double-Blind, Randomized, Placebo-Controlled, First-in-Human Study of Subcutaneously Administered ALG-125755 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single Ascending Doses in Healthy Volunteers (Part 1) and Subjects With Chronic Hepatitis B (Part 2), and Multiple Doses in Subjects With Chronic Hepatitis B (Part 3)",TERMINATED,,PHASE1,57.0,ACTUAL,Aligos Therapeutics,,2.0,,Single doses demonstrated an acceptable safety profile and antiviral activity at all doses evaluated.,f,,,,,f,f,,,,,,,,,,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,INDUSTRY,,,,,,,2023,0.0
NCT05783180,,2023-03-09,,,2023-11-08,2023-03-22,2023-03-24,ACTUAL,,,,,,,2023-11-08,2023-11-13,ACTUAL,2023-06,ESTIMATED,2023-06-30,2023-11,2023-11-30,2024-11,ESTIMATED,2024-11-30,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,LACTYFERRIN™ Forte and ZINC Defense™ and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19,"A Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (Liposomal Bovine Lactoferrin (LbLf) and Liposomal Zn (LZn)) and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Keralty Hospital, Miami",,2.0,,Sponsor decided not to move forward with the trial,f,,,,t,t,f,,,,,,,,,,,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,OTHER,,,,,,,2024,0.0
NCT04818346,,2021-03-25,2023-05-22,,2024-03-19,2021-03-25,2021-03-26,ACTUAL,2023-06-15,2023-07-05,ACTUAL,,,,2024-03-19,2024-04-11,ACTUAL,2021-05-06,ACTUAL,2021-05-06,2024-03,2024-03-31,2023-05-24,ACTUAL,2023-05-24,2022-05-24,ACTUAL,2022-05-24,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of INCB054707 Followed by an Extension Period in Participants With Vitiligo",COMPLETED,,PHASE2,171.0,ACTUAL,Incyte Corporation,,4.0,,,f,,,,t,t,f,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency,2024-10-15 12:37:23.29143,2024-10-15 12:37:23.29143,INDUSTRY,,,,,,,2023,1.0
NCT03194867,,2017-06-19,2024-04-02,,2024-05-21,2017-06-19,2017-06-21,ACTUAL,2024-05-21,2024-06-14,ACTUAL,,,,2024-05-21,2024-06-14,ACTUAL,2018-02-21,ACTUAL,2018-02-21,2024-05,2024-05-31,2023-04-05,ACTUAL,2023-04-05,2023-04-05,ACTUAL,2023-04-05,,INTERVENTIONAL,,"Phase 1:The Safety population: All screened participants who received at least 1 dose or a part of a dose of study treatments (isatuximab or cemiplimab), regardless of the amount of treatment administered. Phase 2: The Randomized population: All participants who gave informed consent, were assigned randomization number by interactive response technology (IRT), regardless of whether they received any study treatment or received a different study treatment from which they were randomized.",Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients,"A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination With Cemiplimab in Patients With Relapsed/Refractory Multiple Myeloma",COMPLETED,,PHASE1/PHASE2,109.0,ACTUAL,Sanofi,,3.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,INDUSTRY,,,,,,,2023,1.0
NCT03452917,,2018-02-12,2021-01-03,,2023-04-27,2018-03-01,2018-03-02,ACTUAL,2023-04-27,2023-05-24,ACTUAL,,,,2023-04-27,2023-05-24,ACTUAL,2018-02-08,ACTUAL,2018-02-08,2023-04,2023-04-30,2020-04-30,ACTUAL,2020-04-30,2019-12-31,ACTUAL,2019-12-31,,INTERVENTIONAL,SNOCAT,5 patients were excluded since they were incarcerated or were less than 18 years of age. We were not allowed to use their data. There were 1492 patients available for analysis.,Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest,Randomized Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest,COMPLETED,,PHASE2/PHASE3,1502.0,ACTUAL,University of Washington,,2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,OTHER,,,,,,,2020,1.0
NCT05043649,,2021-08-31,,,2024-05-13,2021-09-07,2021-09-14,ACTUAL,,,,,,,2024-05-13,2024-05-16,ACTUAL,2021-09-22,ACTUAL,2021-09-22,2024-05,2024-05-31,2024-05-13,ACTUAL,2024-05-13,2023-10-31,ACTUAL,2023-10-31,,INTERVENTIONAL,,,Camsirubicin + Pegfilgrastim to Determine MTD in ASTS,"A Phase 1b, Open-label, Dose-escalation Clinical Study Evaluating the Safety of Camsirubicin With Prophylactic Pegfilgrastim in the Treatment of Advanced Soft Tissue Sarcomas",TERMINATED,,PHASE1,14.0,ACTUAL,Monopar Therapeutics,,1.0,,lack of timely enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,INDUSTRY,,,,,,,2024,0.0
NCT04917679,,2020-12-01,,,2023-10-17,2021-06-01,2021-06-08,ACTUAL,,,,,,,2023-10-17,2023-10-19,ACTUAL,2020-09-01,ACTUAL,2020-09-01,2023-06,2023-06-30,2022-06-01,ACTUAL,2022-06-01,2021-12-01,ACTUAL,2021-12-01,,INTERVENTIONAL,,,Eltrombopag Plus Diacerein vs Eltrombopag in Adult ITP,Eltrombopag Plus Diacerein vs Eltrombopag in Adult Primary Immune Thrombocytopenia: a Multicenter Randomized Controlled Trial,COMPLETED,,PHASE2,102.0,ACTUAL,Qilu Hospital of Shandong University,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,OTHER,,,,,,,2022,1.0
NCT02393859,,2015-03-16,2020-06-24,,2024-05-10,2015-03-19,2015-03-20,ESTIMATED,2020-06-24,2020-07-13,ACTUAL,,,,2024-05-10,2024-05-29,ACTUAL,2015-11-10,ACTUAL,2015-11-10,2024-05,2024-05-31,2022-11-21,ACTUAL,2022-11-21,2019-07-17,ACTUAL,2019-07-17,,INTERVENTIONAL,,"The FAS included all randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received.",Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL),"Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects With HR First Relapse B-precursor ALL",COMPLETED,,PHASE3,111.0,ACTUAL,Amgen,,2.0,,,f,,,,t,,,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,INDUSTRY,,,,,,,2022,1.0
NCT00960544,,2009-08-17,,,2019-06-12,2009-08-17,2009-08-18,ESTIMATED,,,,,,,2019-06-12,2019-06-14,ACTUAL,2019-01,ESTIMATED,2019-01-31,2019-06,2019-06-30,2021-01,ESTIMATED,2021-01-31,2021-01,ESTIMATED,2021-01-31,,INTERVENTIONAL,,,Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism,Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism Using a Limited Pharmacokinetic Sampling Plan,WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Principal Investigator departed from institution,f,,,,t,t,f,,,,,,,,,,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,OTHER,,,,,,,2021,0.0
NCT03433144,,2018-02-08,,,2021-08-02,2018-02-13,2018-02-14,ACTUAL,,,,,,,2021-08-02,2021-08-06,ACTUAL,2018-06-01,ACTUAL,2018-06-01,2021-08,2021-08-31,2020-07-06,ACTUAL,2020-07-06,2019-02-01,ACTUAL,2019-02-01,,INTERVENTIONAL,TXA-OMFS,,The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery,The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery,WITHDRAWN,,PHASE4,0.0,ACTUAL,Nova Scotia Health Authority,,2.0,,Lack of funding,f,,,,,f,f,,,,,,,,,NO,The data will be used for internal use only,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,OTHER,,,,,,,2020,0.0
NCT03071094,,2017-02-10,2021-09-22,,2021-10-21,2017-02-28,2017-03-06,ACTUAL,2021-10-21,2021-11-19,ACTUAL,,,,2021-10-21,2021-11-19,ACTUAL,2017-07-27,ACTUAL,2017-07-27,2021-10,2021-10-31,2021-02-03,ACTUAL,2021-02-03,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,,Phase I and Phase IIa: Participants who received at least one dose of either study drug.,A Trial to Evaluate the Safety and Efficacy of the Combination of the Oncolytic Immunotherapy Pexa-Vec With the PD-1 Receptor Blocking Antibody Nivolumab in the First-line Treatment of Advanced Hepatocellular Carcinoma (HCC),A Phase I/IIa Trial to Evaluate the Safety and Efficacy of the Combination of the Oncolytic Immunotherapy Pexa-Vec With the PD-1 Receptor Blocking Antibody Nivolumab in the First-line Treatment of Advanced Hepatocellular Carcinoma (HCC),TERMINATED,,PHASE1/PHASE2,14.0,ACTUAL,Transgene,"The study was terminated prematurely as per Sponsor's decision based on the failure of Pexa-Vec and nivolumab in their respective pivotal trials in HCC. As a consequence, the enrollment in Phase IIa was not completed.",2.0,,"The decision was taken to stop prematurely the trial due to the failure of Pexa-Vec and nivolumab in their respective pivotal trials (i.e., PHOCUS and CheckMate 459).",f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,INDUSTRY,,,,,,,2021,0.0
NCT04367168,,2020-04-24,,,2022-08-08,2020-04-27,2020-04-29,ACTUAL,,,,,,,2022-08-08,2022-08-10,ACTUAL,2020-05-27,ACTUAL,2020-05-27,2021-08,2021-08-31,2021-08-16,ACTUAL,2021-08-16,2021-04-27,ACTUAL,2021-04-27,,INTERVENTIONAL,ColchiVID,,Colchicine in Patients With Mild and Severe Coronavirus Disease,"Double-blind, Placebo-controlled Clinical Trial of the Use of Colchicine for the Management of Patients With Mild and Severe SARS-Cov2 Infection",TERMINATED,,PHASE2,116.0,ACTUAL,Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran,,2.0,,The intervention was not effective for the outcomes,f,,,,t,f,f,,,f,,,6 months after publication of the clinical trial,Reviewers of scientific journals and researchers who contact the principal researcher by e-mail,,YES,All IPD that underlie results in a publication,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,OTHER,,,,,,,2021,0.0
NCT03971617,,2019-05-30,2022-10-26,,2023-04-10,2019-05-31,2019-06-03,ACTUAL,2023-04-10,2023-04-12,ACTUAL,,,,2023-04-10,2023-04-12,ACTUAL,2019-05-29,ACTUAL,2019-05-29,2023-04,2023-04-30,2021-04-29,ACTUAL,2021-04-29,2021-04-29,ACTUAL,2021-04-29,,INTERVENTIONAL,,,Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease,"A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability of Molecular Hydrogen in Patients With Parkinson's Disease",TERMINATED,,PHASE2/PHASE3,2.0,ACTUAL,Stony Brook University,"Due to low enrollment in this study, we are not able to report on study outcome measures for participants and are unable to draw conclusions.",2.0,,Insufficient enrollment to answer research question,f,,,,,t,f,,,,,,,,,,,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,OTHER,,,,,,,2021,0.0
NCT02808247,,2016-06-17,,,2021-09-10,2016-06-17,2016-06-21,ESTIMATED,,,,,,,2021-09-10,2021-09-20,ACTUAL,2017-07-07,ACTUAL,2017-07-07,2021-09,2021-09-30,2021-04-14,ACTUAL,2021-04-14,2020-11-03,ACTUAL,2020-11-03,,INTERVENTIONAL,ANITA,,Ph II Nintedanib vs. Ifosfamide in Soft Tissue Sarcoma,A Phase II Multicenter Study Comparing the Efficacy of the Oral Angiogenesis Inhibitor Nintedanib With the Intravenous Cytotoxic Compound Ifosfamide for Treatment of Patients With Advanced Metastatic Soft Tissue Sarcoma After Failure of Systemic Non-oxazaphosporine-based First Line Chemotherapy for Inoperable Disease ANITA,TERMINATED,,PHASE2,80.0,ACTUAL,European Organisation for Research and Treatment of Cancer - EORTC,,2.0,,Exceed of pre-specified number of failures in the experimental arm,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,NETWORK,,,,,,,2021,0.0
NCT03549689,,2018-04-26,,,2021-03-10,2018-05-25,2018-06-08,ACTUAL,,,,,,,2021-03-10,2021-03-15,ACTUAL,2019-08-01,ESTIMATED,2019-08-01,2021-03,2021-03-31,2021-07-01,ESTIMATED,2021-07-01,2021-07-01,ESTIMATED,2021-07-01,,INTERVENTIONAL,ReNew,,Effect of Reducing Nucleotide Exposure on Bone Health (ReNew),Effect of Reducing Nucleotide Exposure on Bone Health (ReNew),WITHDRAWN,,PHASE2,0.0,ACTUAL,Stanford University,,2.0,,Withdrawn by drug manufacturer,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,OTHER,,,,,,,2021,0.0
NCT03196765,,2017-05-05,,,2019-03-06,2017-06-21,2017-06-23,ACTUAL,,,,,,,2019-03-06,2019-03-07,ACTUAL,2018-08,ESTIMATED,2018-08-31,2018-05,2018-05-31,2020-12-01,ESTIMATED,2020-12-01,2020-12-01,ESTIMATED,2020-12-01,,INTERVENTIONAL,,,"Safety, Pharmacokinetics and Pharmacodynamics of NV1205 in Pediatric Male Subjects With Adrenoleukodystrophy","Phase I/II, Open-Label, Dose Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of NV1205 in Pediatric Male Subjects With Childhood Cerebral Adrenoleukodystrophy (CCALD)",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"NeuroVia, Inc.",,,,No funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,INDUSTRY,,,,,,,2020,0.0
NCT03892018,,2019-03-19,,,2023-05-19,2019-03-25,2019-03-27,ACTUAL,,,,,,,2023-05-19,2023-05-22,ACTUAL,2019-08-05,ACTUAL,2019-08-05,2022-10,2022-10-31,2023-05-12,ACTUAL,2023-05-12,2023-05-12,ACTUAL,2023-05-12,,INTERVENTIONAL,,,The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol,"An Open-label, Crossover Study of the Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol",TERMINATED,,PHASE1,29.0,ACTUAL,"Athenex, Inc.",,2.0,,STUDY HALTED DUE TO FINANCIAL CONTRAINTS,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,INDUSTRY,,,,,,,2023,0.0
NCT02994771,,2016-11-10,,,2023-04-20,2016-12-13,2016-12-16,ESTIMATED,,,,,,,2023-04-20,2023-04-24,ACTUAL,2016-06,ACTUAL,2016-06-30,2023-04,2023-04-30,2022-04-05,ACTUAL,2022-04-05,2019-02-03,ACTUAL,2019-02-03,,INTERVENTIONAL,,,A Phase I Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema,"A Phase I Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of Lymfactin® (AdAptVEGF-C Adenoviral Vector) in Combination With a Surgical Lymph Node Transfer for the Treatment of Patients With Secondary Lymphedema",TERMINATED,,PHASE1,15.0,ACTUAL,Herantis Pharma Plc.,,2.0,,Lack of efficacy,f,,,,t,,,,,,,,,,,NO,,2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,INDUSTRY,,,,,,,2022,0.0
NCT02065700,,2014-02-14,2024-01-11,,2024-05-06,2014-02-15,2014-02-19,ESTIMATED,2024-05-06,2024-06-04,ACTUAL,,,,2024-05-06,2024-06-04,ACTUAL,2014-02-25,ACTUAL,2014-02-25,2024-05,2024-05-31,2023-01-19,ACTUAL,2023-01-19,2023-01-19,ACTUAL,2023-01-19,,INTERVENTIONAL,DARWIN3,"The Safety Analysis Set included all participants who enrolled in the extension study and received at least one dose of study drug. As prespecified in the protocol, data was collected and analyzed based on their originating parent study I.e. DARWIN 1 and DARWIN 2.",Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants,"A Multicenter, Open-label, Long-term Follow-up Safety and Efficacy Study of GLPG0634 Treatment in Subjects With Moderately to Severely Active Rheumatoid Arthritis",COMPLETED,,PHASE2,739.0,ACTUAL,Galapagos NV,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified external researchers may request IPD for clinical trials that support an approved indication in the EU and the US for which Galapagos is the Marketing Authorisation / New Drug Application Holder, with a marketing authorisation date on or after January 1, 2021 and for which the summary results have been published on ClinicalTrials.gov (CT.gov) and/or the EU Clinical Trials Register (EU CTR). For clinical trials of newly approved compounds or indications the IPD can be requested at earliest 6 months after the EMA and FDA approval. The study last patient last visit (LPLV) must have occurred at least 18 months prior to the request.",2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,INDUSTRY,,,,,,,2023,1.0
NCT03403725,,2018-01-04,2021-01-04,,2021-08-31,2018-01-10,2018-01-19,ACTUAL,2021-08-31,2021-09-28,ACTUAL,,,,2021-08-31,2021-09-28,ACTUAL,2017-08-28,ACTUAL,2017-08-28,2021-02,2021-02-28,2020-01-08,ACTUAL,2020-01-08,2019-10-22,ACTUAL,2019-10-22,,INTERVENTIONAL,CD205SHUTTLE,,MEN1309 I.v. Infusion in Pts With CD205-positive Metastatic Solid Tumors and Relapsed or Refractory NHL Ph I Study,"Open-Label, Multicenter, Phase I Dose Escalation Study of MEN1309, a CD205 Antibody-Drug Conjugate,in Patients With CD205-Positive Metastatic Solid Tumors and Non-Hodgkin Lymphoma",TERMINATED,,PHASE1,28.0,ACTUAL,Menarini Group,,1.0,,"Terminated after achievement of MTD, without progressing to cohort expansion for Company decision.",f,,,,f,f,f,,,,,,,,,,,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,INDUSTRY,,,,,,,2020,0.0
NCT04602065,,2020-09-30,,,2023-03-12,2020-10-20,2020-10-26,ACTUAL,,,,,,,2023-03-12,2023-03-15,ACTUAL,2020-11-24,ACTUAL,2020-11-24,2023-03,2023-03-31,2023-02-28,ACTUAL,2023-02-28,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,,,Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type) Trial,"Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type), a Multicenter, Open-label Phase Ib/II Trial",TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,2.0,,"Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.",f,,,,t,f,f,,,,,,,,,,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,INDUSTRY,,,,,,,2023,0.0
NCT04862143,,2021-04-21,2023-06-21,,2024-06-17,2021-04-23,2021-04-27,ACTUAL,2024-02-19,2024-02-20,ACTUAL,,,,2024-06-17,2024-06-20,ACTUAL,2022-03-08,ACTUAL,2022-03-08,2024-06,2024-06-30,2022-09-19,ACTUAL,2022-09-19,2022-09-19,ACTUAL,2022-09-19,,INTERVENTIONAL,TELEPIK,,Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant,"Open-label, Multicenter, Pilot-trial Evaluating the Safety and Utility of a Hybrid Decentralized Clinical Trial (DCT) Approach Using a TELEmedicine Platform in Patients With HR-positive/HER2-negative Advanced Breast Cancer With a PIK3CA Mutation Treated With Alpelisib - Fulvestrant TELEPIK Trial",TERMINATED,,PHASE2,2.0,ACTUAL,Novartis,,1.0,,Study early terminated due to low enrollment compared to the anticipated figures,f,,,,f,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,INDUSTRY,,,,,,,2022,0.0
NCT03829696,,2019-01-09,,,2019-05-28,2019-01-31,2019-02-04,ACTUAL,,,,,,,2019-05-28,2019-05-30,ACTUAL,2020-01,ESTIMATED,2020-01-31,2019-05,2019-05-31,2021-01,ESTIMATED,2021-01-31,2021-01,ESTIMATED,2021-01-31,,INTERVENTIONAL,,,Advance Provision of Medication Abortion,Alternative Provision of Medication Abortion Via Advance Provision,WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of California, San Francisco",,1.0,,The study is not proceeding at this time.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,OTHER,,,,,,,2021,0.0
NCT03771105,,2018-12-07,,,2024-02-13,2018-12-07,2018-12-10,ACTUAL,,,,,,,2024-02-13,2024-02-15,ACTUAL,2019-01-01,ACTUAL,2019-01-01,2024-02,2024-02-29,2024-08,ESTIMATED,2024-08-31,2024-08,ESTIMATED,2024-08-31,,INTERVENTIONAL,,,The Impact of Phosphate Metabolism on Healthy Aging,The Impact of Phosphate Metabolism on Healthy Aging,SUSPENDED,,EARLY_PHASE1,30.0,ESTIMATED,Yale University,,4.0,,lack of funding,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,OTHER,,,,,,,2024,0.0
NCT03695172,,2018-10-02,2021-11-22,,2022-01-03,2018-10-02,2018-10-03,ACTUAL,2022-01-03,2022-01-12,ACTUAL,,,,2022-01-03,2022-01-12,ACTUAL,2019-09-12,ACTUAL,2019-09-12,2022-01,2022-01-31,2021-03-20,ACTUAL,2021-03-20,2021-03-18,ACTUAL,2021-03-18,,INTERVENTIONAL,,,"Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section","Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section",TERMINATED,,PHASE4,12.0,ACTUAL,Duke University,,3.0,,Decline of eligible participants,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,OTHER,,,,,,,2021,0.0
NCT04300140,,2020-03-05,,,2023-10-26,2020-03-05,2020-03-09,ACTUAL,,,,,,,2023-10-26,2023-10-30,ACTUAL,2021-02-26,ACTUAL,2021-02-26,2023-10,2023-10-31,2023-08-14,ACTUAL,2023-08-14,2023-08-14,ACTUAL,2023-08-14,,INTERVENTIONAL,,,Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma,"A Phase 1b/2 Study Of AVB-S6-500 In Combination With Cabozantinib, AVB-S6-500 In Combination With Cabozantinib and Nivolumab, and AVB-S6-500 Monotherapy in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma",TERMINATED,,PHASE1/PHASE2,72.0,ACTUAL,"Aravive, Inc.",,4.0,,Due to business reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,INDUSTRY,,,,,,,2023,0.0
NCT03291353,,2017-06-19,,,2019-04-17,2017-09-19,2017-09-25,ACTUAL,,,,,,,2019-04-17,2019-04-19,ACTUAL,2017-10-17,ACTUAL,2017-10-17,2019-04,2019-04-30,2022-08-19,ESTIMATED,2022-08-19,2019-08-19,ESTIMATED,2019-08-19,,INTERVENTIONAL,,,Phase 0- Pilot Study of Pembrolizumab on Immune Cells in Patient With Refractory Acute Myeloid Leukemia,Phase 0- Pilot Study of Pembrolizumab on Immune Cells in Patient With Refractory Acute Myeloid Leukemia,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Pittsburgh,,1.0,,This study has closed due to slow accrual.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,OTHER,,,,,,,2022,0.0
NCT04168190,,2019-11-18,2022-07-05,,2022-09-01,2019-11-18,2019-11-19,ACTUAL,2022-07-05,2022-08-02,ACTUAL,,,,2022-09-01,2022-09-16,ACTUAL,2019-12-06,ACTUAL,2019-12-06,2022-09,2022-09-30,2021-07-12,ACTUAL,2021-07-12,2021-07-12,ACTUAL,2021-07-12,,INTERVENTIONAL,,,A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (V116) in Adults (V116-001),"A Phase 1/Phase 2, Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Adults.",COMPLETED,,PHASE1/PHASE2,600.0,ACTUAL,Merck Sharp & Dohme LLC,,5.0,,,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,INDUSTRY,,,,,,,2021,1.0
NCT02576574,,2015-10-13,2022-11-07,,2024-03-19,2015-10-14,2015-10-15,ESTIMATED,2022-12-09,2023-01-04,ACTUAL,,,,2024-03-19,2024-03-20,ACTUAL,2015-10-29,ACTUAL,2015-10-29,2024-03,2024-03-31,2024-01-29,ACTUAL,2024-01-29,2021-12-06,ACTUAL,2021-12-06,,INTERVENTIONAL,,,Avelumab in First-line NSCLC (JAVELIN Lung 100),"A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+NSCLC",COMPLETED,,PHASE3,1214.0,ACTUAL,EMD Serono,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,INDUSTRY,,,,,,,2024,1.0
NCT02976766,,2016-11-24,,,2021-04-07,2016-11-25,2016-11-29,ESTIMATED,,,,,,,2021-04-07,2021-04-09,ACTUAL,2017-02-04,ACTUAL,2017-02-04,2021-04,2021-04-30,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Gypenosides Treatment for Optic Neuritis,"Gypenosides Treatment for Optic Neuritis: a Randomised, Double-blind, Placebo-controlled Trial",TERMINATED,,PHASE2,10.0,ACTUAL,First Affiliated Hospital of Guangxi Medical University,,2.0,,Low enrolment,f,,,,,f,f,,,,,,,,,,,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,OTHER,,,,,,,2020,0.0
NCT04475601,,2020-06-08,,,2022-05-30,2020-07-16,2020-07-17,ACTUAL,,,,,,,2022-05-30,2022-06-02,ACTUAL,2020-07-15,ACTUAL,2020-07-15,2021-08,2021-08-31,2021-05-29,ACTUAL,2021-05-29,2021-03-24,ACTUAL,2021-03-24,,INTERVENTIONAL,COVIDENZA,,Enzalutamide Treatment in COVID-19,"A Prospective, Multicenter, Randomized PHASE II Clinical Trial of Enzalutamide Treatment to Decrease the Morbidity in Patients With Corona Virus Disease 2019 (COVID-19)",TERMINATED,,PHASE2,42.0,ACTUAL,Region Västerbotten,,2.0,,"By sponsor, based on DSMB recommendations",f,,,,t,f,f,,,f,,,,,,UNDECIDED,The extent of sharing will be regulated during the trial to consider the integrity of the data according GDPR and national laws,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,OTHER_GOV,,,,,,,2021,0.0
NCT03057951,,2017-02-16,2022-04-20,,2022-06-03,2017-02-16,2017-02-20,ACTUAL,2022-06-03,2022-06-06,ACTUAL,,,,2022-06-03,2022-06-06,ACTUAL,2017-03-02,ACTUAL,2017-03-02,2022-06,2022-06-30,2021-04-26,ACTUAL,2021-04-26,2021-04-26,ACTUAL,2021-04-26,,INTERVENTIONAL,,"Randomised Set (RS), including all randomised patients.",EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved),"A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)",COMPLETED,,PHASE3,5988.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 09:17:24.908599,2024-10-16 09:17:24.908599,INDUSTRY,,,,,,,2021,1.0
NCT03567694,,2018-06-07,,,2021-09-03,2018-06-21,2018-06-26,ACTUAL,,,,,,,2021-09-03,2021-09-08,ACTUAL,2021-10-01,ESTIMATED,2021-10-01,2021-08,2021-08-31,2022-10-12,ESTIMATED,2022-10-12,2022-10-10,ESTIMATED,2022-10-10,,INTERVENTIONAL,,,Single and Multiple Doses of HA115 and Food Effect in Healthy Adult Volunteers,Randomized Double-Blind Placebo-controlled Ascending Dose FIH Study to Evaluate Single and Multiple Doses of HA115 in Healthy Volunteers and to Investigate Food Effect on Pharmacokinetics After Single Oral Doses of HA115,WITHDRAWN,,PHASE1,0.0,ACTUAL,"Conjupro Biotherapeutics, Inc.",,2.0,,Business decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,INDUSTRY,,,,,,,2022,0.0
NCT04991753,,2021-08-02,,2023-08-09,2023-08-09,2021-08-02,2021-08-05,ACTUAL,,,,,2023-08-14,ACTUAL,2023-08-09,2023-08-14,ACTUAL,2021-10-14,ACTUAL,2021-10-14,2023-07,2023-07-31,2022-08-10,ACTUAL,2022-08-10,2022-08-10,ACTUAL,2022-08-10,,INTERVENTIONAL,,,A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis,"A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants With Active Rheumatoid Arthritis Despite Standard Therapy",COMPLETED,,PHASE2,53.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,,t,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,INDUSTRY,,NCT05221619,TEMPORARILY_NOT_AVAILABLE,,,,2022,1.0
NCT05332678,,2022-03-25,,,2023-04-10,2022-04-11,2022-04-18,ACTUAL,,,,,,,2023-04-10,2023-04-11,ACTUAL,2023-03-03,ACTUAL,2023-03-03,2023-04,2023-04-30,2023-04-10,ACTUAL,2023-04-10,2023-04-10,ACTUAL,2023-04-10,,INTERVENTIONAL,[STRIVE-AD],,SLS-005 (Trehalose Injection) in the Treatment of Alzheimer's Disease,"An Open-Label, Proof-of-Concept Study to Evaluate the Safety and Treatment Effects of SLS-005 (Trehalose Injection, 90.5 mg/mL for Intravenous Infusion) in Participants With Alzheimer's Disease (AD)",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Seelos Therapeutics, Inc.",,2.0,,Sponsor Decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 23:24:17.186435,2024-10-15 23:24:17.186435,INDUSTRY,,,,,,,2023,0.0
NCT01639001,,2012-07-10,2016-06-08,,2020-11-16,2012-07-11,2012-07-12,ESTIMATED,2017-01-23,2017-03-13,ACTUAL,,,,2020-11-16,2020-12-08,ACTUAL,2012-09-29,ACTUAL,2012-09-29,2020-11,2020-11-30,2020-01-08,ACTUAL,2020-01-08,2015-06-30,ACTUAL,2015-06-30,,INTERVENTIONAL,,,A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients,"PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF CRIZOTINIB VERSUS PEMETREXED/CISPLATIN OR PEMETREXED/CARBOPLATIN IN PREVIOUSLY UNTREATED EAST ASIAN PATIENTS WITH NON-SQUAMOUS CARCINOMA OF THE LUNG HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS",COMPLETED,,PHASE3,207.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,INDUSTRY,,,,,,,2020,1.0
NCT03123861,,2017-03-26,2020-09-30,,2020-09-30,2017-04-17,2017-04-21,ACTUAL,2020-09-30,2020-10-26,ACTUAL,,,,2020-09-30,2020-10-26,ACTUAL,2017-06-01,ACTUAL,2017-06-01,2020-09,2020-09-30,2020-07-25,ACTUAL,2020-07-25,2020-07-25,ACTUAL,2020-07-25,,INTERVENTIONAL,,,Gabapentin for Postop Pain After SSLF,Randomized Controlled Trial of Gabapentin Versus Placebo for Postoperative Pain After Sacrospinous Ligament Fixation for Pelvic Organ Prolapse,COMPLETED,,PHASE4,45.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,OTHER,,,,,,,2020,1.0
NCT04580121,,2020-10-01,,,2024-05-30,2020-10-07,2020-10-08,ACTUAL,,,,,,,2024-05-30,2024-06-03,ACTUAL,2020-11-04,ACTUAL,2020-11-04,2024-05,2024-05-31,2023-08-09,ACTUAL,2023-08-09,2023-08-09,ACTUAL,2023-08-09,,INTERVENTIONAL,,,"A Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420.","An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420 as a Single Agent in Hematologic and Molecular Relapsed/Refractory Acute Myeloid Leukemia",COMPLETED,,PHASE1,59.0,ACTUAL,Hoffmann-La Roche,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,INDUSTRY,,,,,,,2023,0.0
NCT03582280,,2018-06-19,,,2024-02-25,2018-06-27,2018-07-10,ACTUAL,,,,,,,2024-02-25,2024-02-28,ACTUAL,2018-07-18,ACTUAL,2018-07-18,2024-02,2024-02-29,2022-10-31,ACTUAL,2022-10-31,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,ONCO-004-1,,The Effect of Amorphous Calcium Carbonate (ACC) Treatment on Function and Welfare in Late-stage Solid Cancer Subjects,"Study to Improve the Function and Welfare of Late-stage Solid Cancer Subjects by Amorphous Calcium Carbonate (ACC) Treatment, Administered Orally and Concomitantly With Inhalation",TERMINATED,,PHASE1,11.0,ACTUAL,Amorphical Ltd.,,1.0,,Slow recruitment,f,,,,f,f,f,,,,,,,,,,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,INDUSTRY,,,,,,,2022,0.0
NCT04614246,,2020-11-02,2023-01-13,,2023-07-28,2020-11-02,2020-11-03,ACTUAL,2023-05-28,2023-05-31,ACTUAL,,,,2023-07-28,2023-08-01,ACTUAL,2021-01-29,ACTUAL,2021-01-29,2023-07,2023-07-31,2022-05-03,ACTUAL,2022-05-03,2022-01-17,ACTUAL,2022-01-17,,INTERVENTIONAL,SCHUMANN,Full analysis set (FAS) includes all 215 participants who were randomized to 5 treatment arms.,Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb,"A Randomized, Double-blind, Open for Active Comparator, Parallel-group, Multicenter Phase 2b Study to Assess the Efficacy and Safety of Three Different Doses of P2X3 Antagonist (BAY1817080) Versus Placebo and Elagolix 150 mg in Women With Symptomatic Endometriosis",TERMINATED,,PHASE2,215.0,ACTUAL,Bayer,,5.0,,Study terminated by Sponsor,f,,,,f,t,f,,,,,,,,,NO,"Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,INDUSTRY,,,,,,,2022,0.0
NCT04256655,,2020-01-28,,,2020-09-11,2020-02-03,2020-02-05,ACTUAL,,,,,,,2020-09-11,2020-09-16,ACTUAL,2020-12-01,ESTIMATED,2020-12-01,2020-09,2020-09-30,2021-12-30,ESTIMATED,2021-12-30,2021-12-30,ESTIMATED,2021-12-30,,INTERVENTIONAL,,,"Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of CDX 6114 in PKU Patients","A Phase 1, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of CDX 6114 After Multiple Ascending Oral Dose Administration to Patients With Phenylketonuria (PKU).",WITHDRAWN,,PHASE1,0.0,ACTUAL,Société des Produits Nestlé (SPN),,3.0,,study product composition to move from liquid to solid,f,,,,,t,f,,,,,,,,,,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,INDUSTRY,,,,,,,2021,0.0
NCT04001101,,2019-06-10,,,2021-11-17,2019-06-26,2019-06-27,ACTUAL,,,,,,,2021-11-17,2021-11-30,ACTUAL,2019-10-10,ACTUAL,2019-10-10,2021-11,2021-11-30,2021-11-17,ACTUAL,2021-11-17,2021-11-17,ACTUAL,2021-11-17,,INTERVENTIONAL,,,Anti-PD-1 +/- RT for MSI-H Solid Tumors,A Randomized Phase II Study of Anti-PD-1 and Limited Metastatic Site Radiation Therapy Versus Anti-PD-1 Alone for Patients With Microsatellite Instability-high (MSI-H) and Mismatch Repair Deficient (dMMR) Metastatic Solid Tumors,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of Colorado, Denver",,2.0,,PI has decided to withdraw the study,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,OTHER,,,,,,,2021,0.0
NCT02304991,,2014-11-21,2021-11-17,,2021-12-19,2014-11-26,2014-12-02,ESTIMATED,2021-11-17,2021-12-16,ACTUAL,,,,2021-12-19,2022-01-10,ACTUAL,2015-01,ACTUAL,2015-01-31,2021-01,2021-01-31,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,FARE/SLIT,,FARE Peanut SLIT and Early Tolerance Induction,Peanut Sublingual Immunotherapy Induction of Clinical Tolerance of Newly Diagnosed Peanut Allergic 12 to 48 Month Old Children,COMPLETED,,PHASE2,50.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,OTHER,,,,,,,2020,1.0
NCT03050060,,2017-02-08,2021-11-22,2021-09-30,2022-05-26,2017-02-08,2017-02-10,ACTUAL,2022-05-26,2022-06-22,ACTUAL,2022-05-26,2022-06-22,ACTUAL,2022-05-26,2022-06-22,ACTUAL,2017-06-09,ACTUAL,2017-06-09,2022-05,2022-05-31,2020-07-12,ACTUAL,2020-07-12,2018-10-01,ACTUAL,2018-10-01,,INTERVENTIONAL,,,"Image Guided Hypofractionated Radiation Therapy, Nelfinavir Mesylate, Pembrolizumab, Nivolumab and Atezolizumab in Treating Patients With Advanced Melanoma, Lung, or Kidney Cancer","ImmunoRad: Stratified Phase II Trial of Image Guided Hypofractionated Radiotherapy With Concurrent Nelfinavir and Immunotherapy in Advanced Melanoma, Lung Cancer, and Renal Cell Carcinoma",TERMINATED,,PHASE2,21.0,ACTUAL,University of Washington,,1.0,,Terminated due to slow accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,OTHER,,,,,,,2020,0.0
NCT04409834,,2020-05-28,2023-05-18,,2023-12-22,2020-05-28,2020-06-01,ACTUAL,2023-12-22,2024-01-19,ACTUAL,,,,2023-12-22,2024-01-19,ACTUAL,2020-08-05,ACTUAL,2020-08-05,2023-12,2023-12-31,2022-03-10,ACTUAL,2022-03-10,2022-03-10,ACTUAL,2022-03-10,,INTERVENTIONAL,COVID-PACT,,Prevention of Arteriovenous Thrombotic Events in Critically-Ill COVID-19 Patients Trial,"A Multicenter, Randomized-Controlled Trial to Evaluate the Efficacy and Safety of Antithrombotic Therapy for Prevention of Arterial and Venous Thrombotic Complications in Critically-Ill COVID-19 Patients",COMPLETED,,PHASE4,390.0,ACTUAL,The TIMI Study Group,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,OTHER,,,,,,,2022,1.0
NCT05845008,,2023-04-25,,,2024-03-01,2023-04-25,2023-05-06,ACTUAL,,,,,,,2024-03-01,2024-03-05,ACTUAL,2024-01-15,ESTIMATED,2024-01-15,2024-02,2024-02-29,2024-07-26,ESTIMATED,2024-07-26,2024-07-15,ESTIMATED,2024-07-15,,INTERVENTIONAL,,,A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain,"An Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety of a Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents 12 to Less Than 17 Years of Age With Orthodontic Pain",WITHDRAWN,,PHASE3,0.0,ACTUAL,Johnson & Johnson Consumer and Personal Products Worldwide,,1.0,,The study is no longer required due to change in development program strategy.,f,,,,f,t,f,,,,,,,,http://yoda.yale.edu,YES,Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu,2024-10-16 09:17:24.908599,2024-10-16 09:17:24.908599,INDUSTRY,,,,,,,2024,0.0
NCT03416244,,2018-01-24,,,2022-09-28,2018-01-24,2018-01-31,ACTUAL,,,,,,,2022-09-28,2022-09-29,ACTUAL,2018-02-21,ACTUAL,2018-02-21,2022-09,2022-09-30,2021-11-19,ACTUAL,2021-11-19,2021-11-19,ACTUAL,2021-11-19,,INTERVENTIONAL,RAMONA,,A Multicenter Open-label Phase II Trial to Evaluate Nivolumab and Ipilimumab for 2nd Line Therapy in Elderly Patients With Advanced Esophageal Squamous Cell Cancer,A Multicenter Open-label Phase II Trial to Evaluate Nivolumab and Ipilimumab for 2nd Line Therapy in Elderly Patients With Advanced Esophageal Squamous Cell Cancer,COMPLETED,,PHASE2,66.0,ACTUAL,AIO-Studien-gGmbH,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,OTHER,,,,,,,2021,1.0
NCT03757351,,2018-11-27,,,2022-05-11,2018-11-27,2018-11-28,ACTUAL,,,,,,,2022-05-11,2022-05-12,ACTUAL,2018-12-14,ACTUAL,2018-12-14,2021-03,2021-03-31,2020-06-18,ACTUAL,2020-06-18,2020-06-18,ACTUAL,2020-06-18,,INTERVENTIONAL,,,Study to Evaluate DNL747 in Subjects With Amyotrophic Lateral Sclerosis,"A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL747 in Subjects With Amyotrophic Lateral Sclerosis",TERMINATED,,PHASE1,15.0,ACTUAL,Sanofi,,3.0,,Due to change in Sanofi's development strategy for DNL747/SAR443060 - not due to any safety concerns,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,INDUSTRY,,,,,,,2020,0.0
NCT04016792,,2019-07-10,,,2019-09-17,2019-07-10,2019-07-11,ACTUAL,,,,,,,2019-09-17,2019-09-18,ACTUAL,2019-08,ESTIMATED,2019-08-31,2019-09,2019-09-30,2020-11,ESTIMATED,2020-11-30,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,Classroom Study of SPN-812 in Children With ADHD,An Analog Classroom Study: Efficacy and Safety of SPN-812 in Children With Attention-Deficit/Hyperactivity Disorder,WITHDRAWN,,PHASE3,0.0,ACTUAL,"Supernus Pharmaceuticals, Inc.",,2.0,,Study stopped before enrollment due to non-safety related corporate decision.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 18:46:42.232332,2024-10-16 18:46:42.232332,INDUSTRY,,,,,,,2020,0.0
NCT02617589,,2015-11-26,2020-11-30,2020-01-16,2023-03-01,2015-11-26,2015-12-01,ESTIMATED,2021-01-15,2021-02-03,ACTUAL,2020-01-22,2020-01-29,ACTUAL,2023-03-01,2023-03-28,ACTUAL,2016-03-01,ACTUAL,2016-03-01,2023-03,2023-03-31,2022-03-04,ACTUAL,2022-03-04,2019-01-17,ACTUAL,2019-01-17,,INTERVENTIONAL,CheckMate 498,Baseline characteristics were summarized using all randomized subjects (all enrolled subjects who were randomized to any treatment arm),"An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)",A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498),COMPLETED,,PHASE3,560.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,t,,,,t,t,f,,,,,,,,,,,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,INDUSTRY,,NCT03126643,APPROVED_FOR_MARKETING,,,,2022,1.0
NCT03151408,,2017-05-05,2021-08-20,,2022-03-09,2017-05-11,2017-05-12,ACTUAL,2022-03-09,2022-03-10,ACTUAL,,,,2022-03-09,2022-03-10,ACTUAL,2017-06-23,ACTUAL,2017-06-23,2022-02,2022-02-28,2020-08-20,ACTUAL,2020-08-20,2020-08-20,ACTUAL,2020-08-20,,INTERVENTIONAL,,,An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia,"A Phase III, Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Of Pracinostat In Combination With Azacitidine In Patients ≥18 Years With Newly Diagnosed Acute Myeloid Leukemia Unfit For Standard Induction Chemotherapy",TERMINATED,,PHASE3,406.0,ACTUAL,Helsinn Healthcare SA,"Results of the interim analysis (OS curves crossing at about 300 days) demonstrated futility according to the planned threshold and concluded that it was unlikely to meet the primary endpoint compared to the control group at the final analysis. Based on this outcome, the decision taken was to discontinue the recruitment of patients and terminate the study.",2.0,,The IDMC recommended to stop the study prematurely due to a lack of efficacy.,f,,,,,t,f,,,,,,,,,,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,INDUSTRY,,,,,,,2020,0.0
NCT05477498,,2019-07-05,,,2022-07-25,2022-07-25,2022-07-28,ACTUAL,,,,,,,2022-07-25,2022-07-28,ACTUAL,2021-12-01,ESTIMATED,2021-12-01,2022-07,2022-07-31,2022-12-31,ESTIMATED,2022-12-31,2022-08-31,ESTIMATED,2022-08-31,,INTERVENTIONAL,IRON-HFpEF,,Iron Substitution With Ferric Carboxymaltose as Treatment Strategy for Heart Failure Patients With Preserved Ejection Fraction,"Iron Substitution With Ferric Carboxymaltose as Treatment Strategy for Heart Failure Patients With Preserved Ejection Fraction: A Prospective, Double-blind, Randomized, Placebo-controlled Trial",WITHDRAWN,,PHASE4,0.0,ACTUAL,"Cantonal Hosptal, Baselland",,2.0,,Principal Investigator left institution,f,,,,t,f,f,,,,,,,,,YES,Patient-level anonymised datasets can be requested after completion of all planned analyses and publications from the study centre (anticipated by mid 2022). Public access to the study protocol will be granted by publishing it in a scientific journal.,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,OTHER,,,,,,,2022,0.0
NCT04674748,,2020-12-07,,,2022-11-14,2020-12-14,2020-12-19,ACTUAL,,,,,,,2022-11-14,2022-11-15,ACTUAL,2021-02-03,ACTUAL,2021-02-03,2022-11,2022-11-30,2022-05-13,ACTUAL,2022-05-13,2022-05-13,ACTUAL,2022-05-13,,INTERVENTIONAL,,,"To Assess the Safety, Tolerability and Pharmacokinetics of INCB086550","A Phase 1 Study Exploring the Safety, Tolerability, and Pharmacokinetics of INCB086550 in Japanese Participants With Advanced Solid Tumors",TERMINATED,,PHASE1,3.0,ACTUAL,Incyte Corporation,,1.0,,The study was terminated early due to a business decision.,f,,,,t,t,f,,,t,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,INDUSTRY,,,,,,,2022,0.0
NCT04575766,,2020-09-24,,,2023-08-08,2020-10-01,2020-10-05,ACTUAL,,,,,,,2023-08-08,2023-08-09,ACTUAL,2020-12-30,ACTUAL,2020-12-30,2023-03,2023-03-31,2022-11-15,ACTUAL,2022-11-15,2022-11-08,ACTUAL,2022-11-08,,INTERVENTIONAL,,,A Study of FT-7051 in Men With MCRPC,A Phase 1 Study of FT-7051 in Men With Metastatic Castration-Resistant Prostate Cancer,TERMINATED,,PHASE1,25.0,ACTUAL,Novo Nordisk A/S,,1.0,,Sponsor Decision,f,,,,,t,f,,,,,,,,,,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,INDUSTRY,,,,,,,2022,0.0
NCT03376321,,2017-12-12,2021-03-19,,2021-03-19,2017-12-12,2017-12-18,ACTUAL,2021-03-19,2021-04-14,ACTUAL,,,,2021-03-19,2021-04-14,ACTUAL,2018-01-03,ACTUAL,2018-01-03,2021-03,2021-03-31,2020-04-30,ACTUAL,2020-04-30,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.,"A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection","A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection",TERMINATED,,PHASE3,334.0,ACTUAL,"Janssen Research & Development, LLC","As the study was terminated early after a pre-planned interim analysis which showed futility, the Sponsor decided not to perform the complete analysis planned per protocol. Hence, data was collected and analyzed for safety and selected efficacy parameters only.",2.0,,Study terminated early (date of study termination decision: 28 August 2020) as a result of the outcome of the pre-planned Interim Analysis.,t,,,,t,t,f,,,,,,,,,,,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,INDUSTRY,,NCT03834376,NO_LONGER_AVAILABLE,,,,2020,0.0
NCT03912259,,2018-12-18,2021-02-04,,2023-12-14,2019-04-09,2019-04-11,ACTUAL,2021-03-09,2021-04-05,ACTUAL,,,,2023-12-14,2023-12-19,ACTUAL,2018-12-19,ACTUAL,2018-12-19,2023-12,2023-12-31,2020-02-14,ACTUAL,2020-02-14,2020-02-14,ACTUAL,2020-02-14,,INTERVENTIONAL,,Analysis was performed on Intent-to-treat (ITT) population which consisted of all randomized participants.,Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis,"A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Chinese Adult Patients With Moderate-to-severe Atopic Dermatitis",COMPLETED,,PHASE3,165.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,INDUSTRY,,,,,,,2020,1.0
NCT04536532,,2020-08-28,,,2024-06-20,2020-08-28,2020-09-02,ACTUAL,,,,,,,2024-06-20,2024-06-24,ACTUAL,2020-10-09,ACTUAL,2020-10-09,2024-06,2024-06-30,2023-03-12,ACTUAL,2023-03-12,2023-03-12,ACTUAL,2023-03-12,,INTERVENTIONAL,,,"Evaluation HEC121120 Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study","A Single-center, Randomized, Double-blind, Single and Multiple Dosing, Evaluation HEC121120 Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study",TERMINATED,,PHASE1/PHASE2,52.0,ACTUAL,"Sunshine Lake Pharma Co., Ltd.",,4.0,,Company decision to discontinue trial,f,,,,,f,f,,,,,,,,,,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,INDUSTRY,,,,,,,2023,0.0
NCT04280705,,2020-02-20,2020-09-16,,2022-03-09,2020-02-20,2020-02-21,ACTUAL,2020-09-22,2020-09-25,ACTUAL,,,,2022-03-09,2022-03-14,ACTUAL,2020-02-21,ACTUAL,2020-02-21,2020-04,2020-04-30,2020-05-21,ACTUAL,2020-05-21,2020-05-21,ACTUAL,2020-05-21,,INTERVENTIONAL,,,Adaptive COVID-19 Treatment Trial (ACTT),"A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults",COMPLETED,,PHASE3,1062.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,NIH,,,,,,,2020,1.0
NCT03065218,,2016-10-27,2022-07-05,,2022-07-05,2017-02-22,2017-02-27,ACTUAL,2022-07-05,2022-07-26,ACTUAL,,,,2022-07-05,2022-07-26,ACTUAL,2016-10,ACTUAL,2016-10-31,2022-07,2022-07-31,2021-02-15,ACTUAL,2021-02-15,2021-02-15,ACTUAL,2021-02-15,,INTERVENTIONAL,,Patients who met study inclusion criteria.,99mTc Sestamibi Scans In Thyroglobulin Positive Scan Negative Differentiated Thyroid Cancer (DTC) Patients,"Evaluation of 99mTc Sestamibi Scans In Patients Who Have Differentiated Thyroid Cancer, Elevated Serum Thyroglobulin Levels, and Negative Diagnostic Imaging Studies",TERMINATED,,PHASE4,4.0,ACTUAL,Medstar Health Research Institute,,1.0,,Insufficient recruitment,f,,,,t,t,,,,,,,,,,NO,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,OTHER,,,,,,,2021,0.0
NCT03870763,,2019-03-07,2023-04-20,,2023-05-23,2019-03-11,2019-03-12,ACTUAL,2023-04-20,2023-05-16,ACTUAL,,,,2023-05-23,2023-06-15,ACTUAL,2019-03-19,ACTUAL,2019-03-19,2023-05,2023-05-31,2022-07-21,ACTUAL,2022-07-21,2022-07-21,ACTUAL,2022-07-21,,INTERVENTIONAL,,Safety population included all participants who had received at least 1 dose of study treatment.,Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants,"A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis",TERMINATED,,PHASE3,11.0,ACTUAL,Biogen,The study was terminated because of long-term difficulties in fulfilling the enrolment commitments and changes in paediatric MS landscape which no longer support placebo-controlled trials. Decision to stop study was not based on safety concerns.,3.0,,Decision to stop the trial was based on long-term difficulties in fulfilling our enrolment commitments and changes in paediatric MS landscape which no longer support placebo-controlled trials.Decision to stop study was not based on safety concerns.,f,,,,t,t,f,,,f,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,INDUSTRY,,,,,,,2022,0.0
NCT05223868,,2022-01-24,,2023-12-13,2024-01-04,2022-01-24,2022-02-04,ACTUAL,,,,,2023-12-15,ACTUAL,2024-01-04,2024-01-05,ACTUAL,2022-02-03,ACTUAL,2022-02-03,2024-01,2024-01-31,2022-12-15,ACTUAL,2022-12-15,2022-12-15,ACTUAL,2022-12-15,,INTERVENTIONAL,FRONTIER 1,,A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis,"A Phase 2b Multicenter, Randomized, Placebo Controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis",COMPLETED,,PHASE2,255.0,ACTUAL,"Janssen Research & Development, LLC",,6.0,,,f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,INDUSTRY,,,,,,,2022,1.0
NCT05808673,,2023-03-27,,,2024-04-07,2023-04-10,2023-04-11,ACTUAL,,,,,,,2024-04-07,2024-04-09,ACTUAL,2023-02,ESTIMATED,2023-02-28,2023-02,2023-02-28,2024-07,ESTIMATED,2024-07-31,2024-06,ESTIMATED,2024-06-30,,INTERVENTIONAL,,,Study of CMAB807X Pre- and Post-change in Manufacturing Site and Xgeva® in Healthy Volunteers,"A Randomized, Double-blind, Parallel Controlled, Phase I Three-arm Study, Comparing the PK, PD, Safety, and Immunogenicity of Pre- and Post-change CMAB807X, Post-change CMAB807X and Xgeva® in Healthy Chinese Male Subjects",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Taizhou Mabtech Pharmaceutical Co.,Ltd",,3.0,,Changes in the company's production plan,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,INDUSTRY,,,,,,,2024,0.0
NCT03574220,,2018-06-20,,,2020-04-06,2018-06-20,2018-06-29,ACTUAL,,,,,,,2020-04-06,2020-04-07,ACTUAL,2019-02-19,ACTUAL,2019-02-19,2020-04,2020-04-30,2020-03-21,ACTUAL,2020-03-21,2020-03-21,ACTUAL,2020-03-21,,INTERVENTIONAL,,,Pembrolizumab After Lung SBRT for Medically Inoperable Early Stage Non-small Cell Lung Cancer,A Pilot Study of Adjuvant Pembrolizumab After Lung Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC),WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Case Comprehensive Cancer Center,,1.0,,No accrual - closed by PRMC,f,,,,t,t,f,,,,,,,,,,,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,OTHER,,,,,,,2020,0.0
NCT03579966,,2018-06-05,2024-03-12,,2024-04-15,2018-07-05,2018-07-09,ACTUAL,2024-04-15,2024-05-07,ACTUAL,,,,2024-04-15,2024-05-07,ACTUAL,2018-06-11,ACTUAL,2018-06-11,2024-04,2024-04-30,2022-08-05,ACTUAL,2022-08-05,2022-08-05,ACTUAL,2022-08-05,,INTERVENTIONAL,,,Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis),Long Term Safety Study of Amifampridine Phosphate in Patients With MuSK Antibody Positive and AChR (Acetylcholine Receptor) Antibody Positive Myasthenia Gravis,TERMINATED,,PHASE3,63.0,ACTUAL,"Catalyst Pharmaceuticals, Inc.","The study was terminated due to lack of measure appropriate data. The analysis of the MG-ADL score was removed in Statistical Analysis Plan (SAP), dated 21FEB2023.",1.0,,Lack of measure appropriate data (MG-ADL).,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,INDUSTRY,,,,,,,2022,0.0
NCT04046939,,2019-07-30,2021-11-23,,2023-04-11,2019-08-02,2019-08-06,ACTUAL,2021-11-23,2021-12-22,ACTUAL,,,,2023-04-11,2023-04-13,ACTUAL,2019-08-15,ACTUAL,2019-08-15,2023-04,2023-04-30,2021-03-02,ACTUAL,2021-03-02,2020-12-03,ACTUAL,2020-12-03,,INTERVENTIONAL,EXHALE-1,"Safety population: all subjects who were randomized and received at least 1 dose of study drug (placebo, dexpramipexole) during the Primary Assessment Period.",Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma,"A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Biomarker Study of the Effects of Dexpramipexole on Eosinophils in Subjects With Eosinophilic Asthma",COMPLETED,,PHASE2,534.0,ACTUAL,Knopp Biosciences,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,INDUSTRY,,,,,,,2021,1.0
NCT04944784,,2021-06-16,,,2024-05-28,2021-06-24,2021-06-30,ACTUAL,,,,,,,2024-05-28,2024-05-30,ACTUAL,2021-08-16,ACTUAL,2021-08-16,2024-05,2024-05-31,2023-07-18,ACTUAL,2023-07-18,2023-07-18,ACTUAL,2023-07-18,,INTERVENTIONAL,COURAGE-ALS,,A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS),"A Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)",TERMINATED,,PHASE3,486.0,ACTUAL,Cytokinetics,,4.0,,The DMC recommended the trial be discontinued due to futility following a planned second interim analysis.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,INDUSTRY,,,,,,,2023,0.0
NCT03059277,,2017-02-16,,,2018-06-12,2017-02-16,2017-02-23,ACTUAL,,,,,,,2018-06-12,2018-06-14,ACTUAL,2018-06-01,ESTIMATED,2018-06-01,2018-06,2018-06-30,2020-09-30,ESTIMATED,2020-09-30,2020-06-30,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,Intravitreal Alfibercept for Center Involved DME Previously Managed With Intravitreal Ranibizumab,Efficacy of Intravitreal Aflibercept Injection (IAI) Administered in a Treat and Extend Fashion in Patients With Center Involved Diabetic Macular Edema (DME) Previously Managed With 0.3 mg Intravitreal Ranibizumab,WITHDRAWN,,PHASE4,0.0,ACTUAL,"Southeast Clinical Research Associates, LLC",,1.0,,Site investigator decided to not move forward with study.,f,,,,f,t,f,,,f,,,,,,NO,Site will not be sharing IPD.,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,OTHER,,,,,,,2020,0.0
NCT04374539,,2020-05-02,,,2022-03-24,2020-05-02,2020-05-05,ACTUAL,,,,,,,2022-03-24,2022-04-05,ACTUAL,2020-04-29,ACTUAL,2020-04-29,2022-03,2022-03-31,2021-06-29,ACTUAL,2021-06-29,2021-06-06,ACTUAL,2021-06-06,,INTERVENTIONAL,REP-COVID,,Plasma Exchange in Patients With COVID-19 Disease and Invasive Mechanical Ventilation: a Randomized Controlled Trial,Plasma Exchange in Patients With COVID-19 Disease and Invasive Mechanical Ventilation: a Randomized Controlled Trial,TERMINATED,,PHASE2,36.0,ACTUAL,Fundacion Clinic per a la Recerca Biomédica,,2.0,,inability to recruit more patients,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,OTHER,,,,,,,2021,0.0
NCT03745898,,2018-11-09,2023-05-26,,2023-07-10,2018-11-16,2018-11-19,ACTUAL,2023-07-10,2023-08-01,ACTUAL,,,,2023-07-10,2023-08-01,ACTUAL,2019-04-15,ACTUAL,2019-04-15,2023-07,2023-07-31,2022-06-17,ACTUAL,2022-06-17,2022-06-17,ACTUAL,2022-06-17,,INTERVENTIONAL,,Recruitment incomplete due to early termination,The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea,The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea (LOFT-HF),TERMINATED,,PHASE3,98.0,ACTUAL,Brigham and Women's Hospital,Study incomplete due to early termination,2.0,,Low feasibility of completion within the study period due to delayed site activation and slow participant accrual,f,,,,t,t,f,,,t,,,,,,YES,All relevant deidentified data will be deposited in Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) and the National Sleep Research Resource (NSRR),2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,OTHER,,,,,,,2022,0.0
NCT03580044,,2018-06-04,2024-01-08,,2024-01-08,2018-07-05,2018-07-09,ACTUAL,2024-01-08,2024-02-02,ACTUAL,,,,2024-01-08,2024-02-02,ACTUAL,2020-12-25,ACTUAL,2020-12-25,2024-01,2024-01-31,2023-01-23,ACTUAL,2023-01-23,2023-01-23,ACTUAL,2023-01-23,,INTERVENTIONAL,,Intent to Treat (ITT) analysis set included all randomized participants regardless of receipt of study drug. Participants were analyzed according to the treatment to which they were randomized.,"Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria","A PROSPECTIVE, RANDOMIZED,OPEN-LABEL, COMPARATIVE STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM- AVIBACTAM (ATM-AVI) AND BEST AVAILABLE THERAPY FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO MULTI-DRUG RESISTANT GRAM- NEGATIVE BACTERIA PRODUCING METALLO -Β-LACTAMASE (MBL)",TERMINATED,,PHASE3,15.0,ACTUAL,Pfizer,,2.0,,Recruitment of patients with serious infections caused by gram-negative bacteria producing MBL has been challenging. Date study terminated: 16-Dec-2022.,,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,INDUSTRY,,,,,,,2023,0.0
NCT04095858,,2019-09-18,2022-10-18,,2023-01-11,2019-09-18,2019-09-19,ACTUAL,2022-10-18,2022-11-14,ACTUAL,,,,2023-01-11,2023-02-08,ACTUAL,2021-01-05,ACTUAL,2021-01-05,2023-01,2023-01-31,2021-11-05,ACTUAL,2021-11-05,2021-11-05,ACTUAL,2021-11-05,,INTERVENTIONAL,CATHY,,"Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005)","A Randomized, Double Blind, Placebo Controlled, Multi-center, Phase III Study of CD24Fc for Prevention of Acute Graft-Versus-Host Disease Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation",TERMINATED,,PHASE3,11.0,ACTUAL,"Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)",,2.0,,Business Reasons,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,INDUSTRY,,,,,,,2021,0.0
NCT04541485,,2020-09-07,,,2021-09-16,2020-09-07,2020-09-09,ACTUAL,,,,,,,2021-09-16,2021-09-23,ACTUAL,2020-12-04,ACTUAL,2020-12-04,2021-09,2021-09-30,2021-03-23,ACTUAL,2021-03-23,2021-03-03,ACTUAL,2021-03-03,,INTERVENTIONAL,,,"To Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines)","Phase I Study to Evaluate the Safety, Tolerability, and Pharmacodynamics (PD) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in COVID-19 Patients",TERMINATED,,PHASE1,2.0,ACTUAL,Daewoong Pharmaceutical Co. LTD.,,5.0,,Enrolment was suspended since 09Dec2020 due to a lack of COVID-19 patients.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,INDUSTRY,,,,,,,2021,0.0
NCT03532022,,2018-04-18,,,2022-03-31,2018-05-18,2018-05-22,ACTUAL,,,,,,,2022-03-31,2022-04-08,ACTUAL,2018-10-04,ACTUAL,2018-10-04,2022-03,2022-03-31,2021-07-09,ACTUAL,2021-07-09,2018-10-17,ACTUAL,2018-10-17,,INTERVENTIONAL,RESTORE,,Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy,"An Open-label, Randomized, Titration-blinded, Phase III Study of Efficacy, Safety and Tolerability Of Chronocort® Compared With Standard Glucocorticoid REeplacement Therapy in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia",WITHDRAWN,,PHASE3,0.0,ACTUAL,Diurnal Limited,,2.0,,Protocol re-design required following EU Phase III results,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,INDUSTRY,,,,,,,2021,0.0
NCT04088903,,2019-09-11,,,2020-10-26,2019-09-11,2019-09-13,ACTUAL,,,,,,,2020-10-26,2020-10-28,ACTUAL,2021-04-01,ESTIMATED,2021-04-01,2020-10,2020-10-31,2023-04-01,ESTIMATED,2023-04-01,2023-04-01,ESTIMATED,2023-04-01,,INTERVENTIONAL,,,Study of Daratumumab for Decreasing Circulating Antibodies in Sensitized Patients Awaiting Heart Transplantation,A Phase 1 Study of Daratumumab for Reduction of Circulating Antibodies in Patients With High Allosensitization Awaiting Heart Transplantation,WITHDRAWN,,PHASE1,0.0,ACTUAL,Stanford University,,1.0,,Protocol changed to use subcutaneous rather than intravenous daratumumab.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,OTHER,,,,,,,2023,0.0
NCT04576208,,2020-09-30,,,2020-12-15,2020-09-30,2020-10-06,ACTUAL,,,,,,,2020-12-15,2020-12-17,ACTUAL,2020-11-30,ESTIMATED,2020-11-30,2020-12,2020-12-31,2022-07-31,ESTIMATED,2022-07-31,2022-07-31,ESTIMATED,2022-07-31,,INTERVENTIONAL,,,A Study to Evaluate the Impact of Management Strategies on Gastrointestinal-Related Adverse Events in Participants With Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations Receiving TAK-788,A Randomized Open-label Phase 2 Multicenter Study to Evaluate the Impact of Management Strategies on Gastrointestinal-Related Adverse Events in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Receiving TAK-788,WITHDRAWN,,PHASE2,0.0,ACTUAL,Takeda,,2.0,,Business Decision (no safety or efficacy concerns),f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,INDUSTRY,,,,,,,2022,0.0
NCT04179110,,2019-11-25,,,2022-02-18,2019-11-25,2019-11-27,ACTUAL,,,,,,,2022-02-18,2022-02-22,ACTUAL,2020-09-18,ACTUAL,2020-09-18,2022-02,2022-02-28,2023-06-15,ESTIMATED,2023-06-15,2022-12-15,ESTIMATED,2022-12-15,,INTERVENTIONAL,,,Study of Pembrolizumab and Ramucirumab in Pts With Progressive TCC After Treatment With an Immune Checkpoint Inhibitor,A Phase II Trial of Pembrolizumab and Ramucirumab in Patients With Progressive Transitional Cell Carcinoma After Treatment With an Immune Checkpoint Inhibitor,WITHDRAWN,,PHASE2,0.0,ACTUAL,Yale University,,1.0,,Funding was withdrawn prior to first enrollment.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,OTHER,,,,,,,2023,0.0
NCT05348681,,2022-04-19,2023-05-18,,2023-05-18,2022-04-26,2022-04-27,ACTUAL,2023-05-18,2023-06-13,ACTUAL,,,,2023-05-18,2023-06-13,ACTUAL,2022-07-18,ACTUAL,2022-07-18,2023-05,2023-05-31,2023-02-28,ACTUAL,2023-02-28,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,,,A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS),"A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Hidradenitis Suppurativa",TERMINATED,,PHASE2,25.0,ACTUAL,"Aristea Therapeutics, Inc.",,2.0,,Due to safety findings in ongoing Phase 2 trials.,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,INDUSTRY,,,,,,,2023,0.0
NCT04079738,,2019-09-03,2022-04-11,,2023-08-31,2019-09-04,2019-09-06,ACTUAL,2023-08-31,2023-09-13,ACTUAL,,,,2023-08-31,2023-09-13,ACTUAL,2019-09-20,ACTUAL,2019-09-20,2023-08,2023-08-31,2022-02-23,ACTUAL,2022-02-23,2021-09-22,ACTUAL,2021-09-22,,INTERVENTIONAL,,There was one patient who had been eligible but never received treatment. The seven subjects who received active study treatment have been considered in this baseline analysis population.~This study was terminated due to Funder's decision during Phase I portion of the study.,Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition Ofthe Proteasome Inhibitor Ixazomib,Phase I/II Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition of the Proteasome Inhibitor Ixazomib: Big Ten Cancer Research Consortium BTCRC-HEM17-092,TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,Big Ten Cancer Research Consortium,,2.0,,Funder requested termination due to halting internal development of TAK-659,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,OTHER,,,,,,,2022,0.0
NCT04407689,,2020-05-27,,,2022-03-30,2020-05-28,2020-05-29,ACTUAL,,,,,,,2022-03-30,2022-04-08,ACTUAL,2020-06-08,ACTUAL,2020-06-08,2022-03,2022-03-31,2022-03-30,ACTUAL,2022-03-30,2022-03-30,ACTUAL,2022-03-30,,INTERVENTIONAL,ILIAD-7-FR,,InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection FR BL Cohort,"A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection in France and Belgium",TERMINATED,,PHASE2,34.0,ACTUAL,Revimmune,,2.0,,poor accrual,f,,,,t,f,f,,,,,,,,,NO,publication,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,INDUSTRY,,,,,,,2022,0.0
NCT03339596,,2017-10-24,,,2023-09-18,2017-11-09,2017-11-13,ACTUAL,,,,,,,2023-09-18,2023-09-21,ACTUAL,2017-06-26,ACTUAL,2017-06-26,2023-09,2023-09-30,2023-02-10,ACTUAL,2023-02-10,2023-01-10,ACTUAL,2023-01-10,,INTERVENTIONAL,EPO-T,,Effects of Erythropoietin for Cognitive Side-effects of ECT,Erythropoietin as an add-on Treatment for Cognitive Side-effects of Electroconvulsive Therapy,COMPLETED,,PHASE2,60.0,ACTUAL,"Mental Health Services in the Capital Region, Denmark",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,OTHER,,,,,,,2023,1.0
NCT03468075,,2018-03-09,2020-11-16,,2020-11-16,2018-03-09,2018-03-16,ACTUAL,2020-11-16,2020-12-10,ACTUAL,,,,2020-11-16,2020-12-10,ACTUAL,2018-07-11,ACTUAL,2018-07-11,2020-11,2020-11-30,2020-10-19,ACTUAL,2020-10-19,2019-04-16,ACTUAL,2019-04-16,,INTERVENTIONAL,,,Gemcitabine Plus Ascorbate for Sarcoma in Adults,A Phase II Trial of Gemcitabine Plus High-Dose Ascorbate in Locally Advanced Unresectable or Metastatic Soft Tissue and Bone Sarcomas in Adults,TERMINATED,,PHASE2,10.0,ACTUAL,University of Iowa,"Study terminated early. Ten patients were enrolled in the first stage, and per protocol the study was terminated following interim analysis when 1 or fewer participants had a tumor response.",1.0,,Stopping rules met,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,OTHER,,,,,,,2020,0.0
NCT04188301,,2019-12-02,2023-03-14,,2024-06-01,2019-12-04,2019-12-05,ACTUAL,2023-04-15,2023-05-10,ACTUAL,,,,2024-06-01,2024-06-04,ACTUAL,2019-12-06,ACTUAL,2019-12-06,2024-06,2024-06-30,2022-06-01,ACTUAL,2022-06-01,2022-03-14,ACTUAL,2022-03-14,,INTERVENTIONAL,DOLF IDA/Oncho,,Safety and Efficacy of IDA for Onchocerciasis,"Safety and Efficacy of Combination Therapy With Ivermectin, Diethylcarbamazine, and Albendazole (IDA) for Individuals With Onchocerciasis",COMPLETED,,PHASE2,154.0,ACTUAL,Washington University School of Medicine,"Pause on clinical trial operations between March 2020 - June 2020 due to the COVID-19 pandemic. Decreased health and viability of the adult female worm population in participants may have reduced the study's ability to detect a significant macrofilaricidal effect of IDA. Study enrolled participants with light/moderate infections, which greatly decreased the risk of SAEs occurring. Future studies to assess tolerability of IDA would need to be conducted with higher infection rates.",3.0,,,f,,,,t,t,f,,,t,,,,,,YES,Datasets used for published results will be shared publicly through a journal or other open source data repository so that the broader scientific community can access it. Only de-identified data will be shared publicly.,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,OTHER,,,,,,,2022,1.0
NCT05512494,,2022-08-21,,,2023-09-15,2022-08-21,2022-08-23,ACTUAL,,,,,,,2023-09-15,2023-09-18,ACTUAL,2022-11-27,ACTUAL,2022-11-27,2022-07,2022-07-31,2023-01-24,ACTUAL,2023-01-24,2023-01-24,ACTUAL,2023-01-24,,INTERVENTIONAL,,,"Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated","A Randomized, Double-blind Clinical Trial to Evaluate Lot-to-lot Consistency , Immunogenicity and Safety of Quadrivalent Influenza Vaccine (Split Virion), Inactivated in Health Populations Aged 9~59 Years Old",COMPLETED,,PHASE4,1260.0,ACTUAL,"Sinovac Biotech Co., Ltd",,3.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 12:43:03.589451,2024-10-15 12:43:03.589451,INDUSTRY,,,,,,,2023,1.0
NCT03393806,,2018-01-03,2020-09-28,,2020-09-28,2018-01-03,2018-01-09,ACTUAL,2020-09-28,2020-10-23,ACTUAL,,,,2020-09-28,2020-10-23,ACTUAL,2018-04-18,ACTUAL,2018-04-18,2020-09,2020-09-30,2020-01-06,ACTUAL,2020-01-06,2019-10-09,ACTUAL,2019-10-09,,INTERVENTIONAL,,,Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD),"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",TERMINATED,,PHASE2,17.0,ACTUAL,GlaxoSmithKline,,2.0,,Recruitment was terminated early before meeting target enrolment due to a high screen failure rate and the feasibility of completing the study in a timely way,f,,,,f,f,f,,,,,,IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,INDUSTRY,,,,,,,2020,0.0
NCT04464577,,2020-03-23,,,2022-03-10,2020-07-06,2020-07-09,ACTUAL,,,,,,,2022-03-10,2022-03-25,ACTUAL,2021-04-01,ESTIMATED,2021-04-01,2022-03,2022-03-31,2021-06-08,ESTIMATED,2021-06-08,2021-06-07,ESTIMATED,2021-06-07,,INTERVENTIONAL,,,"A Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Drug Levels and Safety of BMS-986235","A Phase 1, Open-label Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Pharmacokinetics and Safety of BMS-986235",WITHDRAWN,,PHASE1,0.0,ACTUAL,Bristol-Myers Squibb,,3.0,,Business objectives have changed.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:17:24.908599,2024-10-16 09:17:24.908599,INDUSTRY,,,,,,,2021,0.0
NCT03892525,,2019-03-26,,,2021-07-23,2019-03-26,2019-03-27,ACTUAL,,,,,,,2021-07-23,2021-07-26,ACTUAL,2019-07-04,ACTUAL,2019-07-04,2021-07,2021-07-31,2021-04-07,ACTUAL,2021-04-07,2021-04-07,ACTUAL,2021-04-07,,INTERVENTIONAL,,,Study of Intratumoral Selicrelumab With Atezolizumab in Patients With Refractory or Relapsed B Cell Lymphoma,Phase Ib Study Evaluating the Safety and Efficacy of Intratumoral Agonistic Anti-CD40 (Selicrelumab) in Combination With Anti-PDL1 (Atezolizumab) in Patients With Refractory or Relapsed B Cell Lymphoma,TERMINATED,,PHASE1,4.0,ACTUAL,The Lymphoma Academic Research Organisation,,1.0,,End of drug development,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 09:17:24.908599,2024-10-16 09:17:24.908599,OTHER,,,,,,,2021,0.0
NCT03577899,,2018-06-13,,,2021-06-23,2018-06-24,2018-07-05,ACTUAL,,,,,,,2021-06-23,2021-06-24,ACTUAL,2018-09-25,ACTUAL,2018-09-25,2021-06,2021-06-30,2021-05-19,ACTUAL,2021-05-19,2020-09-25,ACTUAL,2020-09-25,,INTERVENTIONAL,,,Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-1),"A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects With Neovascular Age-Related Macular Degeneration (AMD) (PANDA-1)",TERMINATED,,PHASE3,1157.0,ACTUAL,"Chengdu Kanghong Biotech Co., Ltd.",,3.0,,desired primary endpoint was not met,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,INDUSTRY,,,,,,,2021,0.0
NCT03794973,,2019-01-03,,,2020-12-04,2019-01-03,2019-01-07,ACTUAL,,,,,,,2020-12-04,2020-12-08,ACTUAL,2019-12-14,ESTIMATED,2019-12-14,2020-12,2020-12-31,2023-12-14,ESTIMATED,2023-12-14,2021-12-14,ESTIMATED,2021-12-14,,INTERVENTIONAL,DAWN,,Diabetes Autoimmunity Withdrawn in New Onset Patients (DAWN),"A Phase 2b Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of TOL-3021 in Patients With New Onset Type 1 Diabetes Mellitus",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Tolerion, Inc.",,2.0,,Modification to Clinical Development Plan,,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,INDUSTRY,,,,,,,2023,0.0
NCT04498403,,2020-07-31,2021-06-14,,2021-07-20,2020-07-31,2020-08-04,ACTUAL,2021-07-20,2021-08-12,ACTUAL,,,,2021-07-20,2021-08-12,ACTUAL,2020-09-14,ACTUAL,2020-09-14,2021-07,2021-07-31,2020-12-18,ACTUAL,2020-12-18,2020-12-18,ACTUAL,2020-12-18,,INTERVENTIONAL,,Safety population included all participants who took at least 1 dose of study drug. Participants who entered the first Off-Treatment cycle were included.,"A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis","A PHASE 3, MULTICENTER, OPEN-LABEL STUDY OF THE LONG-TERM SAFETY OF CRISABOROLE OINTMENT, 2% IN JAPANESE PEDIATRIC AND ADULT PARTICIPANTS WITH MILD TO MODERATE ATOPIC DERMATITIS",TERMINATED,,PHASE3,40.0,ACTUAL,Pfizer,"Participants were planned to be followed up to Week 56, however due to early termination of the study, participants were followed up to only Week 12.",1.0,,Terminated (This decision was made for business reasons only and is not related to any safety concerns regarding crisaborole.),f,,,,,f,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,INDUSTRY,,,,,,,2020,0.0
NCT03179163,,2017-06-02,2023-11-27,,2024-02-05,2017-06-05,2017-06-07,ACTUAL,2024-02-05,2024-02-28,ACTUAL,,,,2024-02-05,2024-02-28,ACTUAL,2016-07-20,ACTUAL,2016-07-20,2024-02,2024-02-29,2022-12-31,ACTUAL,2022-12-31,2022-08-31,ACTUAL,2022-08-31,,INTERVENTIONAL,H2SPharm,,Peripheral Vascular Effects of Sulfhydryl-containing Antihypertensive Pharmacotherapy on Microvessels in Humans,Peripheral Vascular Effects of Sulfhydryl-containing Antihypertensive Pharmacotherapy on Microvascular Function and Vessel Remodeling in Hypertensive Humans,TERMINATED,,PHASE1/PHASE2,10.0,ACTUAL,Penn State University,,4.0,,COVID shut down human subjects research and then the grant funding expired,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,OTHER,,,,,,,2022,0.0
NCT04147858,,2019-10-29,2023-03-02,,2023-04-07,2019-10-30,2019-11-01,ACTUAL,2023-04-07,2023-04-28,ACTUAL,,,,2023-04-07,2023-04-28,ACTUAL,2019-11-12,ACTUAL,2019-11-12,2023-04,2023-04-30,2022-06-16,ACTUAL,2022-06-16,2022-06-16,ACTUAL,2022-06-16,,INTERVENTIONAL,,,Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia,"A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia",COMPLETED,,PHASE2,310.0,ACTUAL,Aptinyx,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,INDUSTRY,,,,,,,2022,1.0
NCT03792490,,2018-12-28,,,2023-11-29,2018-12-30,2019-01-03,ACTUAL,,,,,,,2023-11-29,2023-11-30,ACTUAL,2019-02-20,ACTUAL,2019-02-20,2023-11,2023-11-30,2023-11-01,ACTUAL,2023-11-01,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,ROCK-ALS,,Inhibition of Rho Kinase (ROCK) With Fasudil as Disease-modifying Treatment for ALS,Inhibition of Rho Kinase (ROCK) With Fasudil as Disease-modifying Treatment for ALS,COMPLETED,,PHASE2,120.0,ACTUAL,University Medical Center Goettingen,,3.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,OTHER,,,,,,,2023,1.0
NCT04734860,,2021-01-29,,,2022-02-09,2021-01-29,2021-02-02,ACTUAL,,,,,,,2022-02-09,2022-02-25,ACTUAL,2021-04,ESTIMATED,2021-04-30,2022-02,2022-02-28,2021-11,ESTIMATED,2021-11-30,2021-09,ESTIMATED,2021-09-30,,INTERVENTIONAL,,,Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms,"A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,2.0,,A different study will be conducted.,f,,,,t,t,f,,,,,,,,,,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,INDUSTRY,,,,,,,2021,0.0
NCT02763384,,2016-05-03,2023-10-04,2023-01-17,2023-10-04,2016-05-04,2016-05-05,ESTIMATED,2023-10-04,2023-10-31,ACTUAL,2023-01-18,2023-01-26,ACTUAL,2023-10-04,2023-10-31,ACTUAL,2016-12-02,ACTUAL,2016-12-02,2023-10,2023-10-31,2022-05-22,ACTUAL,2022-05-22,2022-02-11,ACTUAL,2022-02-11,,INTERVENTIONAL,,,BL-8040 and Nelarabine for Relapsed or Refractory T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma,A Phase IIa Study of BL-8040 in Combination With Nelarabine for Relapsed or Refractory T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma,TERMINATED,,PHASE2,12.0,ACTUAL,Washington University School of Medicine,,1.0,,Low accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,OTHER,,,,,,,2022,0.0
NCT04053062,,2019-08-08,,,2024-01-04,2019-08-08,2019-08-12,ACTUAL,,,,,,,2024-01-04,2024-01-05,ACTUAL,2020-07-16,ACTUAL,2020-07-16,2024-01,2024-01-31,2024-10-15,ESTIMATED,2024-10-15,2022-05-15,ACTUAL,2022-05-15,,INTERVENTIONAL,,,LIGHT-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer,A Phase I Study to Evaluate the Safety and Efficacy of PSMA-CART Co-expressing LIGHT in Treating Patients With Castrate-Resistant Prostate Cancer (CRPC),SUSPENDED,,PHASE1,12.0,ESTIMATED,Bioray Laboratories,,1.0,,Due to efficacy evaluation,f,,,,,f,f,,,,,,,,,,,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,INDUSTRY,,,,,,,2024,0.0
NCT04729205,,2021-01-24,,,2023-09-12,2021-01-24,2021-01-28,ACTUAL,,,,,,,2023-09-12,2023-09-14,ACTUAL,2021-01-13,ACTUAL,2021-01-13,2023-09,2023-09-30,2023-09-12,ACTUAL,2023-09-12,2023-09-10,ACTUAL,2023-09-10,,INTERVENTIONAL,,,Assessment of Safety and Therapeutic Efficacy of Promitil in Combination With Folfox in Patients With GI Malignancies,An Open Phase 1B Study for Assessment of Safety and Therapeutic Efficacy of Promitil in Combination With Oxaliplatin-based Chemotherapy in Patients With Gastro-intestinal Malignancies,TERMINATED,,PHASE1,9.0,ACTUAL,Lipomedix Pharmaceuticals Inc.,,2.0,,Investigational drug not available,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,INDUSTRY,,,,,,,2023,0.0
NCT04493320,,2020-07-27,2023-05-09,,2023-05-18,2020-07-27,2020-07-30,ACTUAL,2023-05-18,2023-05-22,ACTUAL,,,,2023-05-18,2023-05-22,ACTUAL,2021-02-10,ACTUAL,2021-02-10,2023-05,2023-05-31,2021-10-27,ACTUAL,2021-10-27,2021-10-27,ACTUAL,2021-10-27,,INTERVENTIONAL,,,1/2-Dopaminergic Dysfunction in Late-Life Depression (The D3 Study),1/2-Dopaminergic Dysfunction in Late-Life Depression (The D3 Study),TERMINATED,,PHASE4,5.0,ACTUAL,New York State Psychiatric Institute,Data collected in the trial have been presented as required but are considered unreliable.,2.0,,Study terminated by sponsor (NIMH),f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,OTHER,,,,,,,2021,0.0
NCT04192110,,2019-12-06,,,2021-12-01,2019-12-06,2019-12-10,ACTUAL,,,,,,,2021-12-01,2021-12-09,ACTUAL,2020-08-11,ACTUAL,2020-08-11,2021-12,2021-12-31,2020-08-11,ACTUAL,2020-08-11,2020-08-11,ACTUAL,2020-08-11,,INTERVENTIONAL,DOCK,,"Association of Diuretics With Change in Extracellular Volume, Natriuretic Peptides, Symptoms, and Cardiovascular Outcomes in CKD","Association of Diuretics With Change in Extracellular Volume, Natriuretic Peptides, Symptoms, and Cardiovascular Outcomes in CKD",WITHDRAWN,,PHASE4,0.0,ACTUAL,VA Office of Research and Development,,1.0,,The project has ended prior to beginning.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,FED,,,,,,,2020,0.0
NCT04325633,,2020-03-26,,,2021-02-24,2020-03-26,2020-03-27,ACTUAL,,,,,,,2021-02-24,2021-02-25,ACTUAL,2020-04-24,ACTUAL,2020-04-24,2021-02,2021-02-28,2020-12-15,ACTUAL,2020-12-15,2020-12-15,ACTUAL,2020-12-15,,INTERVENTIONAL,ENACOVID,,Efficacy of Addition of Naproxen in the Treatment of Critically Ill Patients Hospitalized for COVID-19 Infection,Efficacy of Addition of Naproxen in the Treatment of Critically Ill Patients Hospitalized for COVID-19 Infection,TERMINATED,,PHASE3,30.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,Stop inclusions for insufficient recruitment,f,,,,t,f,f,,,,,,,,,,,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,OTHER,,,,,,,2020,0.0
NCT02516553,,2015-07-27,2022-11-22,,2023-10-19,2015-08-04,2015-08-06,ESTIMATED,2023-10-19,2024-04-15,ACTUAL,,,,2023-10-19,2024-04-15,ACTUAL,2015-07-08,ACTUAL,2015-07-08,2023-10,2023-10-31,2021-11-23,ACTUAL,2021-11-23,2021-11-23,ACTUAL,2021-11-23,,INTERVENTIONAL,,"For Phase Ib - Schedule B SCLC, Phase Ib - Schedule B mCRPC, DMC decided on 28Nov2018 to lower the dose of SCLC and mCRPC due to safety concern, thus patients treated prior the decision received 2.5mg BI 894999 and patients treated after the decision received 2mg . For Phase Ib - Schedule C NC, the dose was lowered since DMC reclaimed the MTD as 6/3mg on 08Jul2020 after 1 patient already treated with 7/3.5mg, so the first patient in NC and all the following patients were treated with 6/3mg.",BI 894999 First in Human Dose Finding Study in Advanced Malignancies,"An Open Label, Phase Ia/Ib Dose Finding Study With BI 894999 Orally Administered Once a Day in Patients With Advanced Malignancies, With Repeated Administration in Patients With Clinical Benefit",COMPLETED,,PHASE1,174.0,ACTUAL,Boehringer Ingelheim,This trial was closed in accordance with protocol-defined criteria for stopping the trial following assessments of futility. Trial was completed as described in protocol.,22.0,,,f,,,,,,,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,INDUSTRY,,,,,,,2021,1.0
NCT04517110,,2020-08-11,,,2022-09-07,2020-08-14,2020-08-18,ACTUAL,,,,,,,2022-09-07,2022-09-10,ACTUAL,2021-04-09,ACTUAL,2021-04-09,2022-09,2022-09-30,2022-09-07,ACTUAL,2022-09-07,2022-09-07,ACTUAL,2022-09-07,,INTERVENTIONAL,OPIATE,,Perioperative Pregabalin for Reducing Opioid Consumption After Cardiac Surgery,Peri-Operative Pregabalin for Reducing opIoid Consumption AfTer Cardiac surgEry: A Randomized Trial,TERMINATED,,PHASE3,17.0,ACTUAL,Hamilton Health Sciences Corporation,,2.0,,The COVID-19 pandemic has reduced recruitment such that the study is no longer feasible,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,OTHER,,,,,,,2022,0.0
NCT04072380,,2019-08-26,,,2023-10-19,2019-08-26,2019-08-28,ACTUAL,,,,,,,2023-10-19,2023-10-23,ACTUAL,2019-09-21,ACTUAL,2019-09-21,2023-10,2023-10-31,2023-06-13,ACTUAL,2023-06-13,2023-06-07,ACTUAL,2023-06-07,,INTERVENTIONAL,SUVN-G3031,,"A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy","A Phase 2, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 mg and 4 mg SUVN-G3031 Compared to Placebo in Patients With Narcolepsy With and Without Cataplexy",COMPLETED,,PHASE2,190.0,ACTUAL,Suven Life Sciences Limited,,3.0,,,t,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,INDUSTRY,,NCT05530447,NO_LONGER_AVAILABLE,,,,2023,1.0
NCT02833766,,2016-07-12,,,2021-09-27,2016-07-13,2016-07-14,ESTIMATED,,,,,,,2021-09-27,2021-09-29,ACTUAL,2016-10-28,ACTUAL,2016-10-28,2021-09,2021-09-30,2021-08-03,ACTUAL,2021-08-03,2020-10-31,ACTUAL,2020-10-31,,INTERVENTIONAL,,,Anti-EGFR-immunoliposomes Loaded With Doxorubicin in Patients With Advanced Triple Negative EGFR Positive Breast Cancer,Anti-EGFR-immunoliposomes Loaded With Doxorubicin in Patients With Advanced Triple Negative EGFR Positive Breast Cancer - A Multicenter Single Arm Phase II Trial,TERMINATED,,PHASE2,48.0,ACTUAL,Swiss Group for Clinical Cancer Research,,1.0,,the trial was prematurely terminated as per SAKK board decision from 14th of November 2020. The trial is to be terminated after primary endpoint is reached.,f,,,,f,,,,,,,,,,,NO,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,OTHER,,,,,,,2021,0.0
NCT04423367,,2020-06-05,,,2024-02-05,2020-06-05,2020-06-09,ACTUAL,,,,,,,2024-02-05,2024-02-07,ACTUAL,2020-09-13,ACTUAL,2020-09-13,2024-02,2024-02-29,2024-02-06,ACTUAL,2024-02-06,2024-01-31,ACTUAL,2024-01-31,,INTERVENTIONAL,BID-PERAL,,Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment,Safety and Efficacy of Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment: A Prospective Phase II Trial,TERMINATED,,PHASE2,16.0,ACTUAL,"Institute of Hematology & Blood Diseases Hospital, China",,1.0,,Did not meet the anticipated outcome.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,OTHER,,,,,,,2024,0.0
NCT03961048,,2019-05-21,,,2020-01-22,2019-05-21,2019-05-23,ACTUAL,,,,,,,2020-01-22,2020-01-27,ACTUAL,2019-07-23,ACTUAL,2019-07-23,2020-01,2020-01-31,2020-09,ESTIMATED,2020-09-30,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters,Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters,WITHDRAWN,,PHASE4,0.0,ACTUAL,Virginia Commonwealth University,,2.0,,Change in hospital protocol,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,OTHER,,,,,,,2020,0.0
NCT02400242,,2015-03-03,,,2024-07-08,2015-03-23,2015-03-27,ESTIMATED,,,,,,,2024-07-08,2024-07-09,ACTUAL,2015-05-07,ACTUAL,2015-05-07,2024-07,2024-07-31,2024-06-03,ACTUAL,2024-06-03,2024-06-03,ACTUAL,2024-06-03,,INTERVENTIONAL,,,Study of ACY-241 Alone and in Combination With Pomalidomide and Dexamethasone in Multiple Myeloma,"A Phase 1a/1b Multicenter, Single-Arm, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Preliminary Activity of Oral ACY-241 Alone and in Combination With Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed or Relapsed-and-Refractory Multiple Myeloma",TERMINATED,,PHASE1,85.0,ACTUAL,Celgene,,1.0,,Lack of efficacy,f,,,,f,,,,,,,,,,,,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,INDUSTRY,,,,,,,2024,0.0
NCT04730349,,2021-01-26,2022-12-21,,2023-03-22,2021-01-26,2021-01-29,ACTUAL,2023-03-22,2023-03-24,ACTUAL,,,,2023-03-22,2023-03-24,ACTUAL,2021-06-03,ACTUAL,2021-06-03,2023-03,2023-03-31,2022-06-22,ACTUAL,2022-06-22,2022-06-22,ACTUAL,2022-06-22,,INTERVENTIONAL,PIVOT IO 020,,"A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer","Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)",TERMINATED,,PHASE1/PHASE2,15.0,ACTUAL,Bristol-Myers Squibb,"On 14-Apr-2022, a joint decision was made to end the clinical development program for bempegaldesleukin in combination with nivolumab, resulting in the termination of this study. This results disclosure report provides analyses from CA045-020 Part A safety analyses only. Part B of the study (expansion phase) did not enroll any participants.",13.0,,Business objectives have changed,f,,,,t,t,f,,,,,,,,,,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,INDUSTRY,,,,,,,2022,0.0
NCT04951609,,2021-06-30,,,2024-05-27,2021-06-30,2021-07-07,ACTUAL,,,,,,,2024-05-27,2024-05-29,ACTUAL,2021-09-02,ACTUAL,2021-09-02,2024-05,2024-05-31,2024-04-08,ACTUAL,2024-04-08,2024-04-08,ACTUAL,2024-04-08,,INTERVENTIONAL,,,A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to Selective Serotonin Reuptake Inhibitor (SSRI) and Psychotherapy,"A Short-term Exploratory Study to Evaluate Safety, Tolerability and Pharmacokinetics of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to SSRI Monotherapy and Psychotherapy",TERMINATED,,PHASE1,31.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,"Following discussion on pediatric strategy with HAs, it was determined that we have sufficient data to inform next steps for the seltorexant pediatric program.",f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,INDUSTRY,,,,,,,2024,0.0
NCT04345848,,2020-04-07,,,2021-09-07,2020-04-09,2020-04-15,ACTUAL,,,,,,,2021-09-07,2021-09-14,ACTUAL,2020-04-28,ACTUAL,2020-04-28,2021-09,2021-09-30,2021-06-02,ACTUAL,2021-06-02,2021-06-02,ACTUAL,2021-06-02,,INTERVENTIONAL,COVID-HEP,,Preventing COVID-19 Complications With Low- and High-dose Anticoagulation,"Preventing COVID-19-associated Thrombosis, Coagulopathy and Mortality With Low- and High-dose Anticoagulation: a Multicentric Randomized, Open-label Clinical Trial",TERMINATED,,PHASE3,160.0,ACTUAL,"University Hospital, Geneva",,2.0,,Low recruitement,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,OTHER,,,,,,,2021,0.0
NCT02799368,,2016-06-10,,,2020-10-21,2016-06-10,2016-06-14,ESTIMATED,,,,,,,2020-10-21,2020-10-23,ACTUAL,2016-11,,2016-11-30,2020-10,2020-10-31,2020-03,ACTUAL,2020-03-31,2019-05,ACTUAL,2019-05-31,,INTERVENTIONAL,,,Balanced Salt Solution Versus 0.9% Saline Infusion for Prevention of Contrast-induced Acute Kidney Injury (BASIC Trial),"A Randomized, Open Label, Active Control, 2 Parallel Groups, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Balanced Salt Solution Versus 0.9% Saline in Patients With High Risk of Contrast Induced Nephropathy.",COMPLETED,,PHASE3,493.0,ACTUAL,Seoul National University Hospital,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,OTHER,,,,,,,2020,0.0
NCT05154630,,2021-12-09,,,2024-01-17,2021-12-09,2021-12-13,ACTUAL,,,,,,,2024-01-17,2024-01-18,ACTUAL,2022-01-14,ACTUAL,2022-01-14,2023-12,2023-12-31,2023-06-30,ACTUAL,2023-06-30,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,,,Study on Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignant Tumors,Phase I Clinical Trial Evaluating the Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignancies,TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",,1.0,,The sponsor has decided to terminate this study based on the current clinical research status of dual antibody drugs and full communication with the investigators.,f,,,,,f,f,,,,,,,,,,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,INDUSTRY,,,,,,,2023,0.0
NCT02605993,,2015-11-11,2019-01-18,2018-02-18,2022-12-07,2015-11-13,2015-11-17,ESTIMATED,2019-02-15,2019-02-18,ACTUAL,2018-02-18,2018-02-22,ACTUAL,2022-12-07,2023-01-04,ACTUAL,2016-01-04,ACTUAL,2016-01-04,2022-12,2022-12-31,2022-01-12,ACTUAL,2022-01-12,2017-02-23,ACTUAL,2017-02-23,,INTERVENTIONAL,,Safety set: All participants who received at least 1 dose of ravulizumab.,"Open-label, Multiple Ascending Dose Study of Ravulizumab (ALXN1210) in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)","A Phase 2, Open-label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients With Paroxysmal Nocturnal Hemoglobinuria",COMPLETED,,PHASE2,26.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,INDUSTRY,,,,,,,2022,1.0
NCT04625725,,2020-11-10,2022-05-04,,2024-04-03,2020-11-10,2020-11-12,ACTUAL,2022-11-25,2022-12-20,ACTUAL,,,,2024-04-03,2024-05-01,ACTUAL,2020-11-21,ACTUAL,2020-11-21,2024-03,2024-03-31,2023-12-08,ACTUAL,2023-12-08,2022-08-16,ACTUAL,2022-08-16,,INTERVENTIONAL,PROVENT,,"Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.","A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19.",COMPLETED,,PHASE3,5197.0,ACTUAL,AstraZeneca,,5.0,,,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-16 18:52:37.213795,2024-10-16 18:52:37.213795,INDUSTRY,,,,,,,2023,1.0
NCT04158700,,2019-11-07,,,2020-02-17,2019-11-07,2019-11-12,ACTUAL,,,,,,,2020-02-17,2020-02-19,ACTUAL,2019-12-05,ESTIMATED,2019-12-05,2020-02,2020-02-29,2023-05-11,ESTIMATED,2023-05-11,2023-05-11,ESTIMATED,2023-05-11,,INTERVENTIONAL,,,A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer,Phase 1b/2 Study of LY3200882 and Pembrolizumab in Patients With Advanced Cancer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Eli Lilly and Company,,3.0,,The withdrawal is due to a strategic realignment and is not related to any particular safety or efficacy concern.,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,INDUSTRY,,,,,,,2023,0.0
NCT03964051,,2019-05-16,,,2023-12-04,2019-05-23,2019-05-28,ACTUAL,,,,,,,2023-12-04,2023-12-11,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2023-12,2023-12-31,2020-12-21,ACTUAL,2020-12-21,2020-12-21,ACTUAL,2020-12-21,,INTERVENTIONAL,,,Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana).,Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana).,TERMINATED,,PHASE4,7.0,ACTUAL,Odense University Hospital,,1.0,,Finished,f,,,,t,f,f,,,,,,,,,,,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,OTHER,,,,,,,2020,0.0
NCT05465590,,2022-07-16,,,2023-12-16,2022-07-16,2022-07-20,ACTUAL,,,,,,,2023-12-16,2023-12-21,ACTUAL,2022-12,ESTIMATED,2022-12-31,2023-12,2023-12-31,2024-12,ESTIMATED,2024-12-31,2024-11,ESTIMATED,2024-11-30,,INTERVENTIONAL,,,A Phase 1 Study to Evaluate Paclitaxel Conjugated CXC Receptor 4 Antagonist (MB1707) in Patients With Advanced Cancer,A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of MB1707 in Patients With Advanced Cancer,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,"Mainline Biosciences, Inc.",,1.0,,The study was terminated due to Sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,INDUSTRY,,,,,,,2024,0.0
NCT05077969,,2021-10-07,2024-05-22,,2024-07-03,2021-10-12,2021-10-14,ACTUAL,2024-07-03,2024-07-09,ACTUAL,,,,2024-07-03,2024-07-09,ACTUAL,2021-12-29,ACTUAL,2021-12-29,2024-07,2024-07-31,2022-07-08,ACTUAL,2022-07-08,2022-06-28,ACTUAL,2022-06-28,,INTERVENTIONAL,,,Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients,"A Virtual Phase 2 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of the Combination of Famotidine and Celecoxib as a Post-exposure Prophylaxis (PEP) for Newly-infected COVID-19 Patients",TERMINATED,,PHASE2,4.0,ACTUAL,Leidos Life Sciences,The study was not able to enroll the requisite number of patients to evaluate the prespecified endpoints. As a result the study was halted prematurely.,2.0,,Low recruitment,f,,,,t,t,f,,,,,,,,,NO,It is not yet known if there will be a plan to make individual participant data (IPD) available.,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,INDUSTRY,,,,,,,2022,0.0
NCT03822832,,2019-01-28,2022-09-26,2020-12-16,2022-11-15,2019-01-29,2019-01-30,ACTUAL,2022-11-15,2022-12-01,ACTUAL,2022-11-15,2022-12-01,ACTUAL,2022-11-15,2022-12-01,ACTUAL,2019-02-12,ACTUAL,2019-02-12,2022-11,2022-11-30,2020-07-22,ACTUAL,2020-07-22,2020-01-17,ACTUAL,2020-01-17,,INTERVENTIONAL,,"Randomized set (RS): this patient set includes all patients who were randomized into the trial. It will be used for display of patient disposition, baseline and demographic characteristics, and patients with IPDs (Important Protocol Deviations).",A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated,"Phase IIa, Multicentre, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Treatment With BI 655130 in Adult Patients With Moderate to Severe Atopic Dermatitis",COMPLETED,,PHASE2,51.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://trials.boehringer-ingelheim.com,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link http://trials.boehringer-ingelheim.com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.",2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,INDUSTRY,,,,,,,2020,1.0
NCT03940690,,2019-05-06,,,2024-02-15,2019-05-06,2019-05-07,ACTUAL,,,,,,,2024-02-15,2024-02-16,ACTUAL,2019-10-24,ACTUAL,2019-10-24,2024-02,2024-02-29,2024-11,ESTIMATED,2024-11-30,2024-11,ESTIMATED,2024-11-30,,INTERVENTIONAL,COATS-VEGF,,Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease,Multicenter Randomized Controlled Trial on the Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease,SUSPENDED,,PHASE3,30.0,ESTIMATED,Fondation Ophtalmologique Adolphe de Rothschild,,2.0,,awaiting results of interim analysis,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,NETWORK,,,,,,,2024,0.0
NCT04652700,,2020-12-02,,,2023-08-16,2020-12-02,2020-12-03,ACTUAL,,,,,,,2023-08-16,2023-08-21,ACTUAL,2021-03-15,ACTUAL,2021-03-15,2023-08,2023-08-31,2023-08-04,ACTUAL,2023-08-04,2023-08-04,ACTUAL,2023-08-04,,INTERVENTIONAL,Impower-024,,Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024),"A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Men and Transgender Women Who Have Sex With Men, and Are at High Risk for HIV-1 Infection",COMPLETED,,PHASE3,494.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,INDUSTRY,,,,,,,2023,0.0
NCT04770467,,2021-02-22,,,2023-03-02,2021-02-24,2021-02-25,ACTUAL,,,,,,,2023-03-02,2023-03-03,ACTUAL,2021-02,ESTIMATED,2021-02-28,2023-03,2023-03-31,2022-10,ESTIMATED,2022-10-31,2022-10,ESTIMATED,2022-10-31,,INTERVENTIONAL,,,"A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19","A Phase 2, Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Human Monoclonal Antibodies, BRII-196 and BRII-198, Administered by Intravenous Infusion for the Treatment of COVID-19 Patients",WITHDRAWN,,PHASE2,0.0,ACTUAL,Brii Biosciences Limited,,4.0,,The study will no longer move forward due to recent changes in COVID-19 cases in Hong Kong.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,INDUSTRY,,,,,,,2022,0.0
NCT04211389,,2019-12-23,2022-08-23,2021-09-29,2022-12-05,2019-12-23,2019-12-26,ACTUAL,2022-10-17,2022-10-18,ACTUAL,2022-10-17,2022-10-18,ACTUAL,2022-12-05,2022-12-07,ACTUAL,2019-12-17,ACTUAL,2019-12-17,2022-12,2022-12-31,2020-11-23,ACTUAL,2020-11-23,2020-11-23,ACTUAL,2020-11-23,,INTERVENTIONAL,DERMIS-2,,Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis,"A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.3% Administered QD in Subjects With Chronic Plaque Psoriasis",COMPLETED,,PHASE3,442.0,ACTUAL,"Arcutis Biotherapeutics, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,INDUSTRY,,,,,,,2020,1.0
NCT02460367,,2015-05-21,,,2022-04-04,2015-05-29,2015-06-02,ESTIMATED,,,,,,,2022-04-04,2022-04-06,ACTUAL,2016-01,,2016-01-31,2022-04,2022-04-30,2021-01-13,ACTUAL,2021-01-13,2017-07-17,ACTUAL,2017-07-17,,INTERVENTIONAL,,,Immunotherapy Combination Study in Advanced Previously Treated Non-Small Cell Lung Cancer,A Phase 1b/2 Study of Tergenpumatucel-L (HyperAcute Lung) Immunotherapy in Combination With the IDO Pathway Inhibitor Indoximod and Docetaxel in Patients With Advanced Previously Treated Non-Small Cell Lung Cancer (NSCLS),TERMINATED,,PHASE1,16.0,ACTUAL,Lumos Pharma,,1.0,,Lack of enrollment and changing landscape of standard of care.,f,,,,t,,,,,,,,,,,NO,,2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,INDUSTRY,,,,,,,2021,0.0
NCT03201250,,2017-06-19,2022-07-15,,2023-08-25,2017-06-23,2017-06-28,ACTUAL,2022-11-30,2022-12-23,ACTUAL,,,,2023-08-25,2023-09-08,ACTUAL,2018-02-21,ACTUAL,2018-02-21,2023-08,2023-08-31,2021-04-12,ACTUAL,2021-04-12,2021-04-12,ACTUAL,2021-04-12,,INTERVENTIONAL,,We only included the 8 subjects that passed eligibility and were dosed.,Cabozantinib as a Targeted Strategy to Reverse Carfilzomib Resistance in Refractory Multiple Myeloma,A Phase I/II Study of the c-Met Inhibitor Cabozantinib as a Targeted Strategy to Reverse Resistance to the Proteasome Inhibitor Carfilzomib in Refractory Multiple Myeloma,TERMINATED,,PHASE1/PHASE2,11.0,ACTUAL,University of Nebraska,,1.0,,"Phase I response to treatment was not as expected and the myeloma field in treatment has changed since initiating the study, so investigators felt the study should not be pursued into Phase II.",,,,,t,t,f,,,,,,,,,,,2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,OTHER,,,,,,,2021,0.0
NCT04313634,,2020-03-17,2024-06-01,,2024-07-19,2020-03-17,2020-03-18,ACTUAL,2024-07-19,2024-07-22,ACTUAL,,,,2024-07-19,2024-07-22,ACTUAL,2020-06-09,ACTUAL,2020-06-09,2024-07,2024-07-31,2023-06-06,ACTUAL,2023-06-06,2023-06-06,ACTUAL,2023-06-06,,INTERVENTIONAL,,,Targeting Cellular Senescence With Senolytics to Improve Skeletal Health in Older Humans,"Targeting Cellular Senescence With Senolytics to Improve Skeletal Health in Older Humans: A Phase 2, Single-Center, 20-week, Open-Label, Randomized Controlled Trial.",COMPLETED,,PHASE2,74.0,ACTUAL,Mayo Clinic,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,OTHER,,,,,,,2023,1.0
NCT02577367,,2015-09-14,,,2021-09-16,2015-10-14,2015-10-16,ESTIMATED,,,,,,,2021-09-16,2021-09-22,ACTUAL,2015-10-01,ACTUAL,2015-10-01,2021-08,2021-08-31,2020-04-08,ACTUAL,2020-04-08,2020-04-08,ACTUAL,2020-04-08,,INTERVENTIONAL,,,Mean Percentage of Levothyroxine Dosage Increase in Patients With Hypothyroidism Started on Enteral Feeding,The Effect of Holding Tube Feeding When Administering Levothyroxine on the Mean Percentage of Levothyroxine Dosage Increase in Patients With Hypothyroidism Started on Enteral Feeding,WITHDRAWN,,PHASE4,0.0,ACTUAL,Maimonides Medical Center,,2.0,,Lost interest in current study,f,,,,f,,,,,,,,,,,NO,,2024-10-16 09:17:24.908599,2024-10-16 09:17:24.908599,OTHER,,,,,,,2020,0.0
NCT05565092,,2022-09-15,,,2024-07-31,2022-09-30,2022-10-04,ACTUAL,,,,,,,2024-07-31,2024-08-01,ACTUAL,2023-02-22,ACTUAL,2023-02-22,2024-07,2024-07-31,2024-01-09,ACTUAL,2024-01-09,2024-01-09,ACTUAL,2024-01-09,,INTERVENTIONAL,PHOENIX,,"Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Study of ALXN1820 in Adult Participants With Sickle Cell Disease","A Phase 2a, Randomized, Open-Label Study to Evaluate Multiple Dosing Regimens of Subcutaneous ALXN1820 in Adult Participants With Sickle Cell Disease",TERMINATED,,PHASE2,2.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,3.0,,Sponsor decision to terminate program.,f,,,,t,t,f,,,,,,,,,YES,"Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.",2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,INDUSTRY,,,,,,,2024,0.0
NCT04516759,,2020-08-14,2022-04-12,,2022-04-21,2020-08-16,2020-08-18,ACTUAL,2022-04-21,2022-04-25,ACTUAL,,,,2022-04-21,2022-04-25,ACTUAL,2020-08-12,ACTUAL,2020-08-12,2022-04,2022-04-30,2021-05-12,ACTUAL,2021-05-12,2021-04-25,ACTUAL,2021-04-25,,INTERVENTIONAL,ARCADIA,,AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19,"A Phase II, Randomised, Double-blind, Placebo-controlled Clinical Trial to Assess the Safety and Efficacy of AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19",COMPLETED,,PHASE2,170.0,ACTUAL,St George Street Capital,,2.0,,,f,,,,f,f,f,,,f,,,Requests for access to the data will be accepted beginning 6 months after article publication and will continue to be accepted for up to 5 years after publication.,Researchers must submit a methodologically sound research proposal to St George Street using the contact details provided on our website. See link below.,http://www.sgscapital.org,YES,Qualified researchers can request access to deidentified individual participant data (IDP) that underlie the published clinical trial results.,2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,OTHER,,,,,,,2021,1.0
NCT03744663,,2018-11-09,,,2022-06-01,2018-11-15,2018-11-16,ACTUAL,,,,,,,2022-06-01,2022-06-06,ACTUAL,2022-06,ESTIMATED,2022-06-30,2022-06,2022-06-30,2022-12,ESTIMATED,2022-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films,A Randomized Pilot Study of Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films,WITHDRAWN,,PHASE2,0.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,Funding for uninsured subjects could not be realized and staffing after COVID hit was also a problem.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,OTHER,,,,,,,2022,0.0
NCT02750514,,2016-04-21,2021-01-27,,2021-02-23,2016-04-22,2016-04-25,ESTIMATED,2021-02-23,2021-03-22,ACTUAL,,,,2021-02-23,2021-03-22,ACTUAL,2016-05-09,ACTUAL,2016-05-09,2021-02,2021-02-28,2020-01-29,ACTUAL,2020-01-29,2020-01-29,ACTUAL,2020-01-29,,INTERVENTIONAL,FRACTION-Lung,,An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer,"A Phase 2, Fast Real Time Assessment of Combination Therapies in Immuno-Oncology Study in Subjects With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)",TERMINATED,,PHASE2,295.0,ACTUAL,Bristol-Myers Squibb,This study was terminated early by sponsor for reasons unrelated to safety.,5.0,,The standard of care for the patient population changed and we were unable to accrue any longer.,f,,,,t,t,f,,,,,,,,,,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,INDUSTRY,,,,,,,2020,0.0
NCT02493361,,2015-07-06,2019-04-26,,2020-12-11,2015-07-08,2015-07-09,ESTIMATED,2019-08-06,2019-08-21,ACTUAL,,,,2020-12-11,2021-01-06,ACTUAL,2015-08-17,ACTUAL,2015-08-17,2020-12,2020-12-31,2020-03-02,ACTUAL,2020-03-02,2018-04-26,ACTUAL,2018-04-26,,INTERVENTIONAL,,,Trial of pIL-12/MK-3475 in Metastatic Melanoma,"An Open-label, Phase II, Multicenter Study of Enhancing Pembrolizumab Responses in Melanoma Through Intratumoral pIL-12 Electroporation",COMPLETED,,PHASE2,24.0,ACTUAL,"University of California, San Francisco",Closed to enrollment earlier than expected due to high response rate in order to advance to phase 2b in proven PD1-refractory patients. A total of 24 patients were consented instead of the planned enrollment of 42 patients.,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,OTHER,,,,,,,2020,1.0
NCT04603742,,2020-10-21,,,2022-01-14,2020-10-23,2020-10-27,ACTUAL,,,,,,,2022-01-14,2022-01-25,ACTUAL,2021-12,ESTIMATED,2021-12-31,2022-01,2022-01-31,2022-09,ESTIMATED,2022-09-30,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,SOBI,,"Anakinra, COVID-19, Cytokine Storm","Anakinra in Adults With Severe COVID-19 and Features of Cytokine Storm Syndrome: A Randomized, Double-blind, Placebo-controlled Trial",WITHDRAWN,,PHASE2,0.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,Funding did not go through,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,OTHER,,,,,,,2022,0.0
NCT04128020,,2019-10-14,,,2020-10-09,2019-10-14,2019-10-16,ACTUAL,,,,,,,2020-10-09,2020-10-12,ACTUAL,2019-10-10,ACTUAL,2019-10-10,2020-10,2020-10-31,2020-09-28,ACTUAL,2020-09-28,2020-09-28,ACTUAL,2020-09-28,,INTERVENTIONAL,,,Azacitidine Plus Nivolumab Following Reduced-intensity Allogeneic PBSC Transplantation for Patients With AML and High-risk Myelodysplasia,Phase I Trial of Azacitidine Plus Nivolumab Following Reduced-intensity Allogeneic PBSC Transplantation for Patients With AML and High-risk Myelodysplasia Big Ten Cancer Research Consortium BTCRC-AML18-342,WITHDRAWN,,PHASE1,0.0,ACTUAL,Big Ten Cancer Research Consortium,,2.0,,Funder withdrew funding after not accruing any subjects after 1 year.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,OTHER,,,,,,,2020,0.0
NCT03489850,,2018-03-08,2021-04-09,,2021-10-04,2018-03-29,2018-04-06,ACTUAL,2021-10-04,2021-10-07,ACTUAL,,,,2021-10-04,2021-10-07,ACTUAL,2018-07-16,ACTUAL,2018-07-16,2021-10,2021-10-31,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,,Ibudilast and Withdrawal-Related Dysphoria,Withdrawal-Related Dysphoria as a Moderator of Ibudilast for Alcohol Use Disorder,COMPLETED,,PHASE2,52.0,ACTUAL,"University of California, Los Angeles",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 09:22:51.538102,2024-10-16 09:22:51.538102,OTHER,,,,,,,2020,1.0
NCT02924727,,2016-10-04,2022-01-20,,2023-06-16,2016-10-04,2016-10-05,ESTIMATED,2023-06-16,2023-06-22,ACTUAL,,,,2023-06-16,2023-06-22,ACTUAL,2016-12-09,ACTUAL,2016-12-09,2023-06,2023-06-30,2021-02-26,ACTUAL,2021-02-26,2021-02-26,ACTUAL,2021-02-26,,INTERVENTIONAL,PARADISE-MI,"The Full Analysis Set (FAS) consisted of 5661 patients and consisted of patients in the Randomized population who were not mis-randomized patients. Out of the 5669 patients randomized, a total of 8 patients were mis-randomized, 4 from each treatment group. Following the intent-to-treat (ITT) principle, patients in the FAS were analyzed according to the treatment they were assigned to at randomization.",Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI,"A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Ramipril on Morbidity and Mortality in High Risk Patients Following an Acute Myocardial Infarction (AMI)",COMPLETED,,PHASE3,5669.0,ACTUAL,Novartis,"In this study there were 25 patients who did not take study treatment after randomization, and thus were not included in the safety set.",2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,INDUSTRY,,,,,,,2021,1.0
NCT05472662,,2022-07-14,2023-11-16,,2024-07-12,2022-07-21,2022-07-25,ACTUAL,2024-07-12,2024-10-11,ESTIMATED,,,,2024-07-12,2024-10-11,ESTIMATED,2022-08-03,ACTUAL,2022-08-03,2024-07,2024-07-31,2022-10-31,ACTUAL,2022-10-31,2022-10-31,ACTUAL,2022-10-31,,INTERVENTIONAL,,,A Study to Compare the Effects of Two Propellants in Adults With Mild Asthma,"A Single-dose, Randomised, Double-blind, Controlled, 2-way Cross-over Study to Assess the Potential for Bronchoconstriction of the New Propellant HFA-152a Versus the Marketed HFA-134a Propellant, in Adult Subjects With Mild Asthma",COMPLETED,,PHASE2,25.0,ACTUAL,Chiesi Farmaceutici S.p.A.,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,INDUSTRY,,,,,,,2022,1.0
NCT05163223,,2021-04-02,,,2024-06-13,2021-12-06,2021-12-20,ACTUAL,,,,,,,2024-06-13,2024-06-17,ACTUAL,2022-02-28,ACTUAL,2022-02-28,2024-06,2024-06-30,2024-05-31,ACTUAL,2024-05-31,2024-05-31,ACTUAL,2024-05-31,,INTERVENTIONAL,Cornerstone001,,"Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer","A Phase 2 Study to Evaluate the Efficacy and Safety of an Adjuvant Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With HER2 Low Breast Cancer (Cornerstone-001)",TERMINATED,,PHASE2,10.0,ACTUAL,Aston Sci. Inc.,,2.0,,Difficulty in recruiting patients,,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,INDUSTRY,,,,,,,2024,0.0
NCT05223699,,2022-01-14,,,2023-02-06,2022-02-03,2022-02-04,ACTUAL,,,,,,,2023-02-06,2023-02-09,ACTUAL,2022-02-14,ACTUAL,2022-02-14,2023-02,2023-02-28,2023-02-02,ACTUAL,2023-02-02,2023-02-02,ACTUAL,2023-02-02,,INTERVENTIONAL,,,Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB),"A Phase I/II, Dose-Escalation Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB)",TERMINATED,,PHASE1,22.0,ACTUAL,"Magenta Therapeutics, Inc.",,1.0,,Sponsor Decision,f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:22:51.538102,2024-10-16 09:22:51.538102,INDUSTRY,,,,,,,2023,0.0
NCT04870801,,2021-04-29,,,2022-06-27,2021-04-29,2021-05-04,ACTUAL,,,,,,,2022-06-27,2022-06-30,ACTUAL,2022-01,ESTIMATED,2022-01-31,2022-06,2022-06-30,2024-01,ESTIMATED,2024-01-31,2024-01,ESTIMATED,2024-01-31,,INTERVENTIONAL,,,An Alternative Way To Deliver Oxygen To People,Evaluation of Respirogen Oxygen Microbubble Technology: Efficacy for Human Use During Rest in Normal and Low-oxygen Environments,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Colorado State University,,2.0,,The project was denied funding and the protocol was subsequently closed. No participants were enrolled.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,OTHER,,,,,,,2024,0.0
NCT03994731,,2019-06-19,2022-03-04,,2024-06-14,2019-06-19,2019-06-21,ACTUAL,2022-05-12,2022-05-16,ACTUAL,,,,2024-06-14,2024-06-26,ACTUAL,2019-06-13,ACTUAL,2019-06-13,2024-06,2024-06-30,2022-04-11,ACTUAL,2022-04-11,2021-03-17,ACTUAL,2021-03-17,,INTERVENTIONAL,MIRROR RCT,,Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout,"A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients With Uncontrolled Gout Receiving KRYSTEXXA® (Pegloticase) (MIRROR Randomized Controlled Trial [RCT])",COMPLETED,,PHASE4,152.0,ACTUAL,Amgen,,2.0,,,f,,,,t,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,INDUSTRY,,,,,,,2022,1.0
NCT05441930,,2022-06-19,,,2024-04-11,2022-06-28,2022-07-01,ACTUAL,,,,,,,2024-04-11,2024-04-12,ACTUAL,2023-06-23,ESTIMATED,2023-06-23,2024-04,2024-04-30,2024-03-14,ESTIMATED,2024-03-14,2023-12-15,ESTIMATED,2023-12-15,,INTERVENTIONAL,,,A Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery,"An Interventional, Open Label, Controlled, Randomized, Pairwise, Phase Ib Safety, Tolerability and Pharmacokinetic (PK) Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery",WITHDRAWN,,PHASE1,0.0,ACTUAL,PolyActiva Pty Ltd,,2.0,,Sponsor has suspended study to conserve capital for clinical development of lead asset,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,INDUSTRY,,,,,,,2024,0.0
NCT03943446,,2019-05-07,2023-08-11,,2023-08-11,2019-05-07,2019-05-09,ACTUAL,2023-08-11,2023-09-07,ACTUAL,,,,2023-08-11,2023-09-07,ACTUAL,2020-08-04,ACTUAL,2020-08-04,2023-08,2023-08-31,2022-08-25,ACTUAL,2022-08-25,2022-08-25,ACTUAL,2022-08-25,,INTERVENTIONAL,,Full analysis set (FAS) included all participants to whom study treatment had been assigned by randomization and received at least 1 dose of study drug.,A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery,"A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn's Disease Recurrence",TERMINATED,,PHASE2,34.0,ACTUAL,Takeda,This study is terminated as the sponsor decided to discontinue study due to inability to recruit the expected number of participants within the requisite time period.,3.0,,Sponsor decision to discontinue study due to inability to recruit the expected number of subjects within the requisite time period.,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 09:22:51.538102,2024-10-16 09:22:51.538102,INDUSTRY,,,,,,,2022,0.0
NCT04420299,,2020-06-05,,,2022-06-03,2020-06-05,2020-06-09,ACTUAL,,,,,,,2022-06-03,2022-06-07,ACTUAL,2020-06-04,ACTUAL,2020-06-04,2022-06,2022-06-30,2021-06-08,ACTUAL,2021-06-08,2021-06-08,ACTUAL,2021-06-08,,INTERVENTIONAL,,,Clinical Trial on the Efficacy and Safety of Bemiparin in Patients Hospitalized Because of COVID-19,"A Randomized, Single-blind Study With a Parallel Control Group on the Efficacy and Safety of Bemiparin at Therapeutic Dose vs. Prophylactic Dose in Patients Hospitalized for COVID-19",TERMINATED,,PHASE2,81.0,ACTUAL,Fundación de investigación HM,,2.0,,Lack of funding of the non-commercial sponsor to extend recruitment and reach the target number of patients specified in the protocol.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,OTHER,,,,,,,2021,0.0
NCT05083078,,2021-10-11,,,2022-07-22,2021-10-11,2021-10-19,ACTUAL,,,,,,,2022-07-22,2022-07-26,ACTUAL,2021-11-04,ACTUAL,2021-11-04,2022-07,2022-07-31,2022-07-01,ACTUAL,2022-07-01,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,,,A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis,A Phase 1 Study to Assess the Relative PK and Tissue Distribution of Guselkumab and Risankizumab in Healthy Participants and Patients With Psoriatic Arthritis,TERMINATED,,PHASE1,11.0,ACTUAL,"Janssen Research & Development, LLC",,3.0,,The study was stopped due to unanticipated feasibility constraints.,f,,,,f,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,INDUSTRY,,,,,,,2022,0.0
NCT02725268,,2016-03-28,2020-05-22,,2021-10-28,2016-03-28,2016-03-31,ESTIMATED,2020-05-22,2020-06-09,ACTUAL,,,,2021-10-28,2021-11-24,ACTUAL,2016-04-01,ACTUAL,2016-04-01,2021-10,2021-10-31,2020-10-30,ACTUAL,2020-10-30,2019-07-02,ACTUAL,2019-07-02,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all randomized participants.,"A Study of Sapanisertib, Combination of Sapanisertib With MLN1117, Paclitaxel and Combination of Sapanisertib With Paclitaxel in Women With Endometrial Cancer","A Phase 2, Randomized Study of MLN0128 (a Dual TORC1/2 Inhibitor), MLN0128+MLN1117 (a PI3Kα Inhibitor), Weekly Paclitaxel, or the Combination of Weekly Paclitaxel and MLN0128 in Women With Advanced, Recurrent, or Persistent Endometrial Cancer",COMPLETED,,PHASE2,241.0,ACTUAL,Takeda,,4.0,,,f,,,,f,t,f,,,,,,,,,YES,"Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",2024-10-16 09:22:51.538102,2024-10-16 09:22:51.538102,INDUSTRY,,,,,,,2020,1.0
NCT03985423,,2019-05-23,2022-05-03,,2023-09-14,2019-06-12,2019-06-13,ACTUAL,2023-09-14,2023-10-06,ACTUAL,,,,2023-09-14,2023-10-06,ACTUAL,2020-06-02,ACTUAL,2020-06-02,2023-09,2023-09-30,2021-06-29,ACTUAL,2021-06-29,2021-06-29,ACTUAL,2021-06-29,,INTERVENTIONAL,,The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab.,"A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Emapalumab in Adult Patients With HLH","A Phase 2/3, Open-label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Emapalumab in Adult Patients With Hemophagocytic Lymphohistiocytosis",TERMINATED,,PHASE2/PHASE3,7.0,ACTUAL,Swedish Orphan Biovitrum,"Since the study was prematurely terminated, and considering the low number of patients enrolled, no analysis related to primary and secondary efficacy endpoints and no Pharmacokinetic and Pharmacodynamic summary statistics were performed. Accordingly, no conclusion on the efficacy of emapalumab on this patient population could be withdrawn from the study.",1.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,INDUSTRY,,,,,,,2021,0.0
NCT04644484,,2020-11-16,2023-02-24,,2023-03-29,2020-11-19,2020-11-25,ACTUAL,2023-03-29,2023-04-21,ACTUAL,,,,2023-03-29,2023-04-21,ACTUAL,2020-09-23,ACTUAL,2020-09-23,2023-03,2023-03-31,2022-12-16,ACTUAL,2022-12-16,2022-06-24,ACTUAL,2022-06-24,,INTERVENTIONAL,,,A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety,A Phase III Randomized Blinded Study to Evaluate SYN023 Compared to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies in Adults With Category III Rabies Exposure Risks,COMPLETED,,PHASE3,1000.0,ACTUAL,"Synermore Biologics (Suzhou) Co., Ltd.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 09:22:51.538102,2024-10-16 09:22:51.538102,INDUSTRY,,,,,,,2022,1.0
NCT05001555,,2021-07-29,,,2023-11-23,2021-08-05,2021-08-12,ACTUAL,,,,,,,2023-11-23,2023-11-27,ACTUAL,2021-11-23,ACTUAL,2021-11-23,2023-11,2023-11-30,2023-04-25,ACTUAL,2023-04-25,2023-04-24,ACTUAL,2023-04-24,,INTERVENTIONAL,WHIPLASH,,Efficacy and Safety of Dexketoprofen/Vitamin B vs Dexketoprofen for Post-traumatic Cervical Sprain Grade I-II,Efficacy and Safety of the Combination Dexketoprofen / Vitamin B vs Dexketoprofen in the Treatment of Pain in Patients With Post-traumatic Cervical Sprain Grade I-II of the Quebec Scale.,COMPLETED,,PHASE3,174.0,ACTUAL,Laboratorios Silanes S.A. de C.V.,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,INDUSTRY,,,,,,,2023,1.0
NCT04401579,,2020-05-22,2021-02-25,,2022-03-09,2020-05-22,2020-05-26,ACTUAL,2021-04-22,2021-04-26,ACTUAL,,,,2022-03-09,2022-03-14,ACTUAL,2020-05-08,ACTUAL,2020-05-08,2020-04,2020-04-30,2020-07-31,ACTUAL,2020-07-31,2020-07-31,ACTUAL,2020-07-31,,INTERVENTIONAL,,,Adaptive COVID-19 Treatment Trial 2 (ACTT-2),"A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTT-2)",COMPLETED,,PHASE3,1033.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,NIH,,,,,,,2020,1.0
NCT05020483,,2021-08-18,,,2022-11-30,2021-08-18,2021-08-25,ACTUAL,,,,,,,2022-11-30,2022-12-05,ACTUAL,2021-10,ESTIMATED,2021-10-31,2022-11,2022-11-30,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients,Activated Prothrombin Complex Concentrate FEIBA to Optimize Postcardiopulomonary Bypass Hemostasis in Pediatric Cardiac Patients,WITHDRAWN,,PHASE2,0.0,ACTUAL,Mayo Clinic,,2.0,,Patient population changed and no subjects eligible for the study.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,OTHER,,,,,,,2023,0.0
NCT03712449,,2018-10-17,2021-07-29,,2023-10-13,2018-10-17,2018-10-19,ACTUAL,2021-07-29,2021-08-25,ACTUAL,,,,2023-10-13,2023-10-31,ACTUAL,2019-01-22,ACTUAL,2019-01-22,2023-10,2023-10-31,2020-07-29,ACTUAL,2020-07-29,2020-07-29,ACTUAL,2020-07-29,,INTERVENTIONAL,,Full Analysis Population included all participants who had met all eligibility criteria at the screening visit and received any product used as treatment in this study.,A Study to Evaluate Participant Satisfaction With Facial Appearance Overall and the Aesthetic and Psychosocial Impact of Combined Facial Treatment,"Canada Global HARMONY: Prospective, Multi-site, Study to Evaluate Subject Satisfaction With Facial Appearance Overall and the Aesthetic and Psychosocial Impact of Combined Facial Treatment",COMPLETED,,PHASE4,59.0,ACTUAL,Allergan,,2.0,,,f,,,,,t,t,,,t,,,,,,NO,,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,INDUSTRY,,,,,,,2020,1.0
NCT03322566,,2017-10-24,2019-12-10,,2022-01-19,2017-10-24,2017-10-26,ACTUAL,2020-01-16,2020-01-29,ACTUAL,,,,2022-01-19,2022-01-24,ACTUAL,2018-01-09,ACTUAL,2018-01-09,2022-01,2022-01-31,2020-10-16,ACTUAL,2020-10-16,2018-12-13,ACTUAL,2018-12-13,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all participants who were randomized to study intervention.,A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06),A Randomized Phase 2 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer,COMPLETED,,PHASE2,233.0,ACTUAL,Incyte Corporation,Data from the final analysis of KEYNOTE-715/ECHO-306 (data cutoff: 13-DEC-2018) indicated that the study did not meet the pre-specified endpoint of improvement in objective response rate (ORR).,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,INDUSTRY,,,,,,,2020,1.0
NCT04211363,,2019-12-23,2022-08-23,2021-09-29,2022-12-05,2019-12-23,2019-12-26,ACTUAL,2022-10-10,2022-11-03,ACTUAL,2022-10-10,2022-11-03,ACTUAL,2022-12-05,2022-12-07,ACTUAL,2019-12-20,ACTUAL,2019-12-20,2022-12,2022-12-31,2020-11-16,ACTUAL,2020-11-16,2020-11-16,ACTUAL,2020-11-16,,INTERVENTIONAL,DERMIS-1,,Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis,"A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.3% Administered QD in Subjects With Chronic Plaque Psoriasis",COMPLETED,,PHASE3,439.0,ACTUAL,"Arcutis Biotherapeutics, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,INDUSTRY,,,,,,,2020,1.0
NCT03738917,,2018-11-05,,,2022-08-29,2018-11-08,2018-11-13,ACTUAL,,,,,,,2022-08-29,2022-08-30,ACTUAL,2019-02-01,ACTUAL,2019-02-01,2021-08,2021-08-31,2021-12-31,ACTUAL,2021-12-31,2021-11-30,ACTUAL,2021-11-30,,INTERVENTIONAL,AB4T,,"Effectiveness of Antitussives, Anticholinergics and Honey Versus Usual Care in Adults With Acute Bronchitis.","Effectiveness of Antitussives, Anticholinergics and Honey Versus Usual Care in Adults With Uncomplicated Acute Bronchitis.",COMPLETED,,PHASE4,668.0,ACTUAL,Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina,,4.0,,,f,,,,t,f,f,,,,,,2021,Scientia,http://scientiasalut.gencat.cat,YES,Reposition of data in Scientia,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,OTHER,,,,,,,2021,0.0
NCT05297045,,2022-02-24,,,2023-11-14,2022-03-16,2022-03-25,ACTUAL,,,,,,,2023-11-14,2023-11-18,ACTUAL,2022-03-29,ACTUAL,2022-03-29,2023-11,2023-11-30,2023-05-30,ACTUAL,2023-05-30,2023-05-30,ACTUAL,2023-05-30,,INTERVENTIONAL,,,A Study of Oral GLP1RA RGT001-075 in Adults With Type 2 Diabetes,"A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study of Oral RGT001-075 in Adult Patients With Uncontrollable Type 2 Diabetes Mellitus on Metformin Therapy",TERMINATED,,PHASE2,17.0,ACTUAL,Regor Pharmaceuticals Inc.,,7.0,,Terminated due to financial constraint.,f,,,,,t,f,,,,,,,,,,,2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,INDUSTRY,,,,,,,2023,0.0
NCT01024920,,2009-11-24,2020-03-26,,2021-06-16,2009-12-02,2009-12-03,ESTIMATED,2020-06-16,2020-06-17,ACTUAL,,,,2021-06-16,2021-07-19,ACTUAL,2009-12-16,,2009-12-16,2021-06,2021-06-30,2020-06-19,ACTUAL,2020-06-19,2011-11-08,ACTUAL,2011-11-08,,INTERVENTIONAL,,Treated set: all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.,Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.,"A Randomised, Open Label, Parallel Group Phase II Study Comparing the Efficacy and Tolerability of BIBF 1120 Versus Sunitinib in Previously Untreated Patients With Renal Cell Cancer",COMPLETED,,PHASE2,99.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 09:22:51.538102,2024-10-16 09:22:51.538102,INDUSTRY,,,,,,,2020,1.0
NCT02985190,,2016-11-07,,,2022-10-03,2016-12-02,2016-12-07,ESTIMATED,,,,,,,2022-10-03,2022-10-04,ACTUAL,2017-01-26,ACTUAL,2017-01-26,2022-10,2022-10-31,2022-08-30,ACTUAL,2022-08-30,2021-09-02,ACTUAL,2021-09-02,,INTERVENTIONAL,,,A Study of Azacitidine in Myelodysplastic Syndrome (MDS) Associated to Systemic Auto-immune and Inflammatory Disorders,A Phase II Study of Efficacy and Tolerance of Azacitidine (AZA) In MDS-associated Steroid Dependent/Refractory Systemic Auto-immune and Inflammatory Disorders (SAID),COMPLETED,,PHASE2,30.0,ACTUAL,Groupe Francophone des Myelodysplasies,,1.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,OTHER,,,,,,,2022,1.0
NCT03936270,,2019-02-05,,,2024-02-18,2019-05-02,2019-05-03,ACTUAL,,,,,,,2024-02-18,2024-02-20,ACTUAL,2020-03-05,ACTUAL,2020-03-05,2024-02,2024-02-29,2023-05-02,ACTUAL,2023-05-02,2022-01-18,ACTUAL,2022-01-18,,INTERVENTIONAL,,,Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer,Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer,COMPLETED,,PHASE2,43.0,ACTUAL,Latin American Cooperative Oncology Group,,1.0,,,f,,,,,f,f,,,f,,,,,,NO,,2024-10-16 09:22:51.538102,2024-10-16 09:22:51.538102,OTHER,,,,,,,2023,1.0
NCT02813902,,2016-06-07,,,2019-03-06,2016-06-24,2016-06-27,ESTIMATED,,,,,,,2019-03-06,2019-03-08,ACTUAL,2019-07,ESTIMATED,2019-07-31,2019-03,2019-03-31,2020-05,ESTIMATED,2020-05-31,2020-05,ESTIMATED,2020-05-31,,INTERVENTIONAL,,,A Trial of Polypodium Leucotomos in Preventing Skin Cancer and Its Precursors,A Pilot Trial of Polypodium Leucotomos in Preventing Skin Cancer and Its Precursors,WITHDRAWN,,PHASE1,0.0,ACTUAL,Massachusetts General Hospital,,2.0,,Lack of funding.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,OTHER,,,,,,,2020,0.0
NCT03542110,,2018-05-18,,,2021-09-15,2018-05-18,2018-05-31,ACTUAL,,,,,,,2021-09-15,2021-09-16,ACTUAL,2018-08-04,ACTUAL,2018-08-04,2021-09,2021-09-30,2020-07-31,ACTUAL,2020-07-31,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,ASAP-SVG,,The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial,Effect of Alirocumab on Saphenous Vein Graft Atherosclerosis: The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial,TERMINATED,,PHASE4,46.0,ACTUAL,Minneapolis Heart Institute Foundation,,2.0,,Withdrawal of medication and funding support by Sponsor,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,OTHER,,,,,,,2020,0.0
NCT03277482,,2017-09-07,,,2023-07-31,2017-09-08,2017-09-11,ACTUAL,,,,,,,2023-07-31,2023-08-01,ACTUAL,2018-06-01,ACTUAL,2018-06-01,2023-07,2023-07-31,2022-07-15,ACTUAL,2022-07-15,2022-07-15,ACTUAL,2022-07-15,,INTERVENTIONAL,,,"Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer","A Phase 1 Study of Durvalumab, Tremelimumab and Radiotherapy in Recurrent Gynecologic Cancer",TERMINATED,,PHASE1,16.0,ACTUAL,Dana-Farber Cancer Institute,,2.0,,Expansion cohort was not open,f,,,,t,t,t,,,,,,,,,NO,,2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,OTHER,,,,,,,2022,0.0
NCT03954990,,2019-04-23,,,2023-12-11,2019-05-16,2019-05-17,ACTUAL,,,,,,,2023-12-11,2023-12-12,ACTUAL,2019-10-11,ACTUAL,2019-10-11,2023-12,2023-12-31,2022-09-26,ACTUAL,2022-09-26,2022-09-26,ACTUAL,2022-09-26,,INTERVENTIONAL,,,Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity,Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity: A Randomized Controlled Trial,TERMINATED,,PHASE1,75.0,ACTUAL,"The University of Texas Medical Branch, Galveston",,2.0,,Lack of significance/futile study,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 09:22:51.538102,2024-10-16 09:22:51.538102,OTHER,,,,,,,2022,0.0
NCT00655876,,2008-04-09,2017-12-20,,2022-05-23,2008-04-09,2008-04-10,ESTIMATED,2018-02-14,2018-03-14,ACTUAL,,,,2022-05-23,2022-06-14,ACTUAL,2008-06,,2008-06-30,2022-05,2022-05-31,2022-05-20,ACTUAL,2022-05-20,2015-04,ACTUAL,2015-04-30,,INTERVENTIONAL,,Eligible patients,"Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer","A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery",COMPLETED,,PHASE3,344.0,ACTUAL,Radiation Therapy Oncology Group,"After a United Kingdom trial failed to show a benefit for cetuximab, accrual was suspended and the 3rd planned interim analysis done. After discussions with the Data Monitoring Committee, the study permanently closed to accrual on 2/8/2013.",2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,NETWORK,,,,,,,2022,1.0
NCT03838731,,2019-02-09,2021-04-28,2020-12-18,2021-06-10,2019-02-09,2019-02-12,ACTUAL,2021-06-10,2021-07-01,ACTUAL,2021-06-10,2021-07-01,ACTUAL,2021-06-10,2021-07-01,ACTUAL,2019-02-12,ACTUAL,2019-02-12,2021-06,2021-06-30,2020-04-06,ACTUAL,2020-04-06,2019-12-21,ACTUAL,2019-12-21,,INTERVENTIONAL,,,Study in Cat-Allergic Patients With Asthma to Evaluate the Efficacy of a Single Dose of REGN1908-1909 to Reduce Bronchoconstriction Upon Cat Allergen Challenge,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study in Cat-Allergic Patients With Asthma to Evaluate the Efficacy of a Single Dose of REGN1908-1909 to Reduce Bronchoconstriction Upon Cat Allergen Challenge",COMPLETED,,PHASE2,56.0,ACTUAL,Regeneron Pharmaceuticals,,2.0,,,f,,,,t,t,f,,,t,,,"Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification","Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in a manuscript. Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification",https://vivli.org/,YES,All IPD that underlie results in a publication,2024-10-15 23:30:03.349222,2024-10-15 23:30:03.349222,INDUSTRY,,,,,,,2020,1.0
NCT04620135,,2020-10-26,2022-12-13,,2023-02-01,2020-11-05,2020-11-06,ACTUAL,2023-02-01,2023-02-27,ACTUAL,,,,2023-02-01,2023-02-27,ACTUAL,2020-11-30,ACTUAL,2020-11-30,2023-02,2023-02-28,2021-07-30,ACTUAL,2021-07-30,2021-07-09,ACTUAL,2021-07-09,,INTERVENTIONAL,,,Efficacy and Safety Study of Netarsudil 0.02% Ophthalmic Solution Compared to Ripasudil Hydrochloride Hydrate 0.4% Ophthalmic Solution in Japanese Subjects With Primary Open Angle Glaucoma or Ocular Hypertension,"A Single-masked, Randomized, Multi-center, Parallel-group, 4-week Study Evaluating the Efficacy and Safety of Once Daily Netarsudil Ophthalmic Solution 0.02% Compared to Twice Daily Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% in Japanese Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)",COMPLETED,,PHASE3,245.0,ACTUAL,Aerie Pharmaceuticals,,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,INDUSTRY,,,,,,,2021,1.0
NCT03768726,,2018-11-19,2021-03-30,,2021-06-15,2018-12-05,2018-12-07,ACTUAL,2021-03-30,2021-04-27,ACTUAL,,,,2021-06-15,2021-06-16,ACTUAL,2018-12-21,ACTUAL,2018-12-21,2021-06,2021-06-30,2020-07-31,ACTUAL,2020-07-31,2020-07-31,ACTUAL,2020-07-31,,INTERVENTIONAL,,The safety analysis set included all participants who took at least 1 dose of study medication in this open-label extension study.,Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder,26-WEEK OPEN-LABEL EXTENSION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (MOST RECENT EPISODE MANIC),TERMINATED,,PHASE3,23.0,ACTUAL,Pfizer,Prioritization of outcome measures per study team's discretion.,1.0,,Pfizer has decided to perform the pre-specified final analysis at the current enrollment using a re-estimation of the sample size.,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,INDUSTRY,,,,,,,2020,0.0
NCT03837743,,2019-02-05,2022-05-27,2020-05-28,2022-08-12,2019-02-08,2019-02-12,ACTUAL,2022-08-12,2022-09-02,ACTUAL,2022-08-12,2022-09-02,ACTUAL,2022-08-12,2022-09-02,ACTUAL,2019-02-21,ACTUAL,2019-02-21,2022-08,2022-08-31,2020-05-20,ACTUAL,2020-05-20,2019-11-11,ACTUAL,2019-11-11,,INTERVENTIONAL,,Safety Population,Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis,"A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Proof of Concept Comparison Study of the Safety and Efficacy of DUR-928 Topical Solution With Occlusion in Subjects With Mild to Moderate Plaque Psoriasis",COMPLETED,,PHASE2,25.0,ACTUAL,Durect,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,INDUSTRY,,,,,,,2020,1.0
NCT04329572,,2020-03-29,,,2022-11-03,2020-03-30,2020-04-01,ACTUAL,,,,,,,2022-11-03,2022-11-07,ACTUAL,2020-04-23,ACTUAL,2020-04-23,2022-11,2022-11-30,2023-06-30,ESTIMATED,2023-06-30,2020-05-31,ACTUAL,2020-05-31,,INTERVENTIONAL,,,Efficacy and Safety of Hydroxychloroquine and Azithromycin for Patients With Moderate to Severe COVID-19,"Open, Multicentric, Non Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Acute Respiratory Syndrome (COVID-19) Caused by SARS-CoV-2 Virus",SUSPENDED,,EARLY_PHASE1,400.0,ESTIMATED,Azidus Brasil,,1.0,,"Azidus, the CRO hired for this study by Prevent Senior has lost the interest to conduct this study.",f,,,,t,f,f,,,,,,,,,NO,"It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.",2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,INDUSTRY,,,,,,,2023,0.0
NCT03186638,,2017-06-07,2023-03-31,,2023-09-13,2017-06-12,2017-06-14,ACTUAL,2023-03-31,2023-04-21,ACTUAL,,,,2023-09-13,2023-09-25,ACTUAL,2017-05-26,ACTUAL,2017-05-26,2023-09,2023-09-30,2022-06-01,ACTUAL,2022-06-01,2022-03-30,ACTUAL,2022-03-30,,INTERVENTIONAL,,,Low-Dose Ibuprofen in Improving Cognitive Impairment in Patients With Cancer,Phase II Study of Low-Dose Ibuprofen for Cognitive Problems in Patients With Cancer,COMPLETED,,PHASE2,87.0,ACTUAL,University of Rochester,,2.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-14 22:03:40.473305,2024-10-14 22:03:40.473305,OTHER,,,,,,,2022,1.0
NCT03380507,,2017-12-07,,,2021-11-29,2017-12-20,2017-12-21,ACTUAL,,,,,,,2021-11-29,2021-12-10,ACTUAL,2018-03-17,ACTUAL,2018-03-17,2019-02,2019-02-28,2021-11-01,ACTUAL,2021-11-01,2019-10-03,ACTUAL,2019-10-03,,INTERVENTIONAL,HYVITS,,"Evaluation of Hydrocortisone, Vitamin C and Thiamine for the Treatment of Septic Shock","Evaluation of Hydrocortisone, Vitamin C and Thiamine for the Treatment of Septic Shock",TERMINATED,,PHASE2/PHASE3,106.0,ACTUAL,Hamad Medical Corporation,,2.0,,The research is no longer funded and terminated due to futility,f,,,,t,f,f,,,t,,,,,,NO,,2024-10-16 09:22:51.538102,2024-10-16 09:22:51.538102,INDUSTRY,,,,,,,2021,0.0
NCT03814135,,2019-01-22,,,2021-03-30,2019-01-22,2019-01-23,ACTUAL,,,,,,,2021-03-30,2021-04-01,ACTUAL,2021-01,ESTIMATED,2021-01-31,2021-03,2021-03-31,2022-03,ESTIMATED,2022-03-31,2022-02,ESTIMATED,2022-02-28,,INTERVENTIONAL,,,Efficacy and Safety of Two Doses of Hipnos in the Treatment of Adults With Insomnia,"Randomized, Double-blind, Double-dummy, National, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Two Doses of Hipnos Medication in the Treatment of Adults With Insomnia",WITHDRAWN,,PHASE2,0.0,ACTUAL,EMS,,3.0,,Sponsor decision,f,,,,t,f,f,,,,,,,,,,,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,INDUSTRY,,,,,,,2022,0.0
NCT04492020,,2020-07-27,2023-04-18,,2023-05-30,2020-07-27,2020-07-30,ACTUAL,2023-05-30,2023-05-31,ACTUAL,,,,2023-05-30,2023-05-31,ACTUAL,2020-08-21,ACTUAL,2020-08-21,2023-05,2023-05-31,2022-04-19,ACTUAL,2022-04-19,2022-04-19,ACTUAL,2022-04-19,,INTERVENTIONAL,UBR Prodrome,Safety Population consists of all treated participants who take at least 1 administration of study intervention,Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants,"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome",COMPLETED,,PHASE3,518.0,ACTUAL,AbbVie,,2.0,,,f,,,,f,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,INDUSTRY,,,,,,,2022,1.0
NCT04343976,,2020-04-09,2022-06-07,,2022-06-29,2020-04-09,2020-04-14,ACTUAL,2022-06-29,2022-07-21,ACTUAL,,,,2022-06-29,2022-07-21,ACTUAL,2020-06-22,ACTUAL,2020-06-22,2022-06,2022-06-30,2021-07-30,ACTUAL,2021-07-30,2021-07-30,ACTUAL,2021-07-30,,INTERVENTIONAL,,,Pegylated Interferon Lambda Treatment for COVID-19,A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda vs. Placebo in Subjects Infected With COVID-19,TERMINATED,,PHASE2,14.0,ACTUAL,Massachusetts General Hospital,"Enrollment was slower than anticipated due to issues operationalizing outpatient follow-up for viremic subjects discharged from hospital prior to study completion, including lack of transportation and delays contracting with home health services to offer home visits. Also, study was terminated prior to meeting enrollment goal due to a decrease in eligible subjects and lack of funding.",2.0,,"Unable to meet enrollment goal, lack of funding.",f,,,,f,t,f,,,,,,"Data is anticiapted to be made available within 3 months of study completion. Safety data, specifically treatment related adverse events, will be shared in real time",researchers accessing IPD must be an approved and have a data use agreement in place with Partners Healthcare to access the data,,YES,Coded data is anticipated to be shared with outside institutions. Safety data will be shared with the drug manufacturer,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,OTHER,,,,,,,2021,0.0
NCT04359511,,2020-04-20,,,2021-05-11,2020-04-20,2020-04-24,ACTUAL,,,,,,,2021-05-11,2021-05-12,ACTUAL,2020-07-03,ACTUAL,2020-07-03,2021-05,2021-05-31,2020-07-03,ESTIMATED,2020-07-03,2020-07-03,ACTUAL,2020-07-03,,INTERVENTIONAL,CORTICOVIDHUGO,,Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia,Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia in Grand Ouest Interregion France,WITHDRAWN,,PHASE3,0.0,ACTUAL,"University Hospital, Tours",,2.0,,COMPETITOR TEST (RECOVERY),f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,OTHER,,,,,,,2020,0.0
NCT03041324,,2017-01-13,2022-05-07,,2022-10-21,2017-01-31,2017-02-02,ESTIMATED,2022-08-30,2022-09-27,ACTUAL,,,,2022-10-21,2022-10-25,ACTUAL,2017-05-11,ACTUAL,2017-05-11,2022-10,2022-10-31,2021-05-07,ACTUAL,2021-05-07,2021-05-07,ACTUAL,2021-05-07,,INTERVENTIONAL,,,Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-913 in Subjects With MPS II,"A Phase I / 2, Multicenter, Open-label, Single-dose, Dose-ranging Study to Assess the Safety and Tolerability of SB-913, a rAAV2/6-based Gene Transfer in Subjects With Mucopolysaccharidosis II (MPS II)",TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,Sangamo Therapeutics,"Due to the limited sample size of 9 subjects, the primary and secondary endpoints could not be analyzed, and this study could not report any conclusions.",3.0,,All nine subjects dosed in the study have rolled over to the Long-Term Follow-up Study IVPRP-LT01 \[NCT04628871\],f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,INDUSTRY,,,,,,,2021,0.0
NCT04203875,,2019-12-12,,,2021-11-17,2019-12-17,2019-12-18,ACTUAL,,,,,,,2021-11-17,2021-11-29,ACTUAL,2020-03-09,ACTUAL,2020-03-09,2021-11,2021-11-30,2020-07-23,ACTUAL,2020-07-23,2020-07-23,ACTUAL,2020-07-23,,INTERVENTIONAL,,,Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis,Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis,TERMINATED,,PHASE1,1.0,ACTUAL,Duke University,,1.0,,Lack of eligible study participants.,f,,,,,t,f,,,,,,,,,NO,There are no plans to share IPD at this time,2024-10-16 18:58:53.601187,2024-10-16 18:58:53.601187,OTHER,,,,,,,2020,0.0
NCT04099277,,2019-09-20,2021-08-04,,2021-08-04,2019-09-20,2019-09-23,ACTUAL,2021-08-04,2021-08-31,ACTUAL,,,,2021-08-04,2021-08-31,ACTUAL,2019-10-28,ACTUAL,2019-10-28,2021-08,2021-08-31,2020-03-05,ACTUAL,2020-03-05,2020-03-05,ACTUAL,2020-03-05,,INTERVENTIONAL,,All randomized participants.,A Study of LY3435151 in Participants With Solid Tumors,A Phase 1a/1b Study of LY3435151 Administered to Patients With Advanced Solid Tumors,TERMINATED,,PHASE1,2.0,ACTUAL,Eli Lilly and Company,"This study was terminated before completion of the dose escalation phase (Part A), due to strategic business decision made by the company.",4.0,,Study terminated due to strategic business decision by Eli Lilly and Company.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,INDUSTRY,,,,,,,2020,0.0
NCT04551300,,2020-08-31,,,2022-10-17,2020-09-10,2020-09-16,ACTUAL,,,,,,,2022-10-17,2022-10-18,ACTUAL,2020-10-13,ACTUAL,2020-10-13,2022-10,2022-10-31,2022-10-15,ACTUAL,2022-10-15,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,,A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients,A Phase 2 Study to Evaluate the Safety and Efficacy of Escalated and Fixed Doses of VS-505(AP301) in Comparison With Sevelamer Carbonate to Treat Hyperphosphatemia in Chronic Kidney Disease Patients Receiving Hemodialysis,COMPLETED,,PHASE2,158.0,ACTUAL,Shanghai Alebund Pharmaceuticals Limited,,5.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,INDUSTRY,,,,,,,2022,1.0
NCT02382588,,2015-03-03,2021-03-29,,2021-06-16,2015-03-05,2015-03-06,ESTIMATED,2021-06-16,2021-07-08,ACTUAL,,,,2021-06-16,2021-07-08,ACTUAL,2013-12-10,ACTUAL,2013-12-10,2021-06,2021-06-30,2020-05-11,ACTUAL,2020-05-11,2020-05-11,ACTUAL,2020-05-11,,INTERVENTIONAL,,Report on Comparison of Topical 0.15% Gancicyclovir Gel vs 0.3% Hypromellose Gel for the treatment of Herpes Zoster keratitis~This study was begun in December of 2013 in order to determine if topical ganciclovir 0.15% was beneficial in the treatment of Herpes Zoster keratitis. Despite the number of years the study was open we were only able to recruit 8 subjects. Data was not summarized due to privacy concerns for participants due to low enrollment The study was closed in May of 2020.,Comparison of Topical 0.15% Gancyclovir Gel Versus 0.3% Hypromellose Gel for the Treatment of Herpes Zoster Keratitis,"A Prospective, Double-masked, Placebo Controlled Comparison of Topical 0.15% Gancyclovir Gel (Zirgan) Versus 0.3% Hypromellose Gel (Genteal Gel; Placebo) for the Treatment of Herpes Zoster Keratitis",TERMINATED,,PHASE2,8.0,ACTUAL,Northwestern University,,2.0,,There were difficulties meeting the enrollment goal within stipulated time frames.,f,,,,f,,,,,,,,,,,YES,Once the study is completed study results will be shared with the study subjects.,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,OTHER,,,,,,,2020,0.0
NCT03769688,,2018-12-06,,,2021-10-28,2018-12-06,2018-12-07,ACTUAL,,,,,,,2021-10-28,2021-11-03,ACTUAL,2022-03,ESTIMATED,2022-03-31,2021-10,2021-10-31,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Safety and Efficacy of Vaginal Microbiota Transplant (VMT) in Women With Bacterial Vaginosis (BV),VMT-01: Safety and Efficacy of Vaginal Microbiota Transplant (VMT) in Women With Bacterial Vaginosis (BV),WITHDRAWN,,PHASE1,0.0,ACTUAL,Johns Hopkins University,,2.0,,Replaced with different study at another site.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,OTHER,,,,,,,2023,0.0
NCT02371369,,2015-02-19,2019-08-26,,2022-04-11,2015-02-19,2015-02-25,ESTIMATED,2020-01-06,2020-01-10,ACTUAL,,,,2022-04-11,2022-05-11,ACTUAL,2015-05-11,ACTUAL,2015-05-11,2022-04,2022-04-30,2021-04-30,ACTUAL,2021-04-30,2017-03-27,ACTUAL,2017-03-27,,INTERVENTIONAL,ENLIVEN,,Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS),"A Double-blind, Randomized, Placebo-controlled Phase 3 Study of Orally Administered PLX3397 in Subjects With Pigmented Villonodular Synovitis or Giant Cell Tumor of the Tendon Sheath",COMPLETED,,PHASE3,120.0,ACTUAL,Daiichi Sankyo,"Enrollment was stopped on 30 Sep 2016; no new participants received the study drug. After Part 1, those who wished to continue were un-blinded; those on placebo were discontinued.",4.0,,,f,,,,t,,,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,INDUSTRY,,,,,,,2021,1.0
NCT02955823,,2016-11-02,,,2022-12-22,2016-11-02,2016-11-04,ESTIMATED,,,,,,,2022-12-22,2022-12-23,ACTUAL,2016-09,,2016-09-30,2022-12,2022-12-31,2022-11-24,ACTUAL,2022-11-24,2020-09-22,ACTUAL,2020-09-22,,INTERVENTIONAL,,,A Phase II Study of the FIL on Elderly Frail Patients With DLBCL,A Combination of Lenalidomide and Rituximab as Front Line Therapy for the Treatment of Elderly Frail Patients Evaluated in CGA With Diffuse Large B-cells Non-Hodgkin Lymphoma. A Phase II Study of the Fondazione Italiana Linfomi (FIL),COMPLETED,,PHASE2,68.0,ACTUAL,Fondazione Italiana Linfomi - ETS,,1.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,OTHER,,,,,,,2022,1.0
NCT00658021,,2008-04-08,2020-09-23,2020-01-14,2020-11-06,2008-04-08,2008-04-14,ESTIMATED,2020-11-06,2020-12-01,ACTUAL,2020-01-14,2020-01-18,ACTUAL,2020-11-06,2020-12-01,ACTUAL,2008-05-30,ACTUAL,2008-05-30,2020-10,2020-10-31,2020-04-01,ACTUAL,2020-04-01,2019-04-18,ACTUAL,2019-04-18,,INTERVENTIONAL,,The Intent-To-Treat analysis set included all randomized participants.,Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes,Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes.,COMPLETED,,PHASE3,122.0,ACTUAL,AstraZeneca,,3.0,,,f,,,,t,,,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment.~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,INDUSTRY,,,,,,,2020,1.0
NCT03792295,,2018-12-27,,,2021-07-28,2018-12-31,2019-01-03,ACTUAL,,,,,,,2021-07-28,2021-08-04,ACTUAL,2021-07-01,ESTIMATED,2021-07-01,2021-07,2021-07-31,2022-07-01,ESTIMATED,2022-07-01,2021-12-01,ESTIMATED,2021-12-01,,INTERVENTIONAL,,,Multimodal Pain Therapy After Hernia Repair,The Effect of Multimodal Pain Therapy After Hernia Repair,WITHDRAWN,,PHASE2,0.0,ACTUAL,George Washington University,,2.0,,"no enrollment, reallocation of resources",f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,OTHER,,,,,,,2022,0.0
NCT04357028,,2020-04-19,,,2020-12-18,2020-04-19,2020-04-22,ACTUAL,,,,,,,2020-12-18,2020-12-22,ACTUAL,2020-07-13,ACTUAL,2020-07-13,2020-12,2020-12-31,2021-01-01,ESTIMATED,2021-01-01,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,MV-COVID19,,Measles Vaccine in HCW,Effectiveness of Measles Vaccine in Health Care Professionals During COVID-19 Outbreak (Randomized Controlled Trial),SUSPENDED,,PHASE3,200.0,ESTIMATED,Kasr El Aini Hospital,,2.0,,Failure of subject recruitment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,OTHER,,,,,,,2021,0.0
NCT01682616,,2012-06-26,,,2023-06-05,2012-09-07,2012-09-11,ESTIMATED,,,,,,,2023-06-05,2023-06-06,ACTUAL,2012-07-25,ACTUAL,2012-07-25,2023-06,2023-06-30,2022-06-23,ACTUAL,2022-06-23,2022-06-23,ACTUAL,2022-06-23,,INTERVENTIONAL,,,A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma,A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma,COMPLETED,,PHASE1,49.0,ACTUAL,AbbVie,,1.0,,,t,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,INDUSTRY,,NCT03123029,AVAILABLE,,,,2022,1.0
NCT03106454,,2017-04-04,,,2023-01-26,2017-04-07,2017-04-10,ACTUAL,,,,,,,2023-01-26,2023-01-30,ACTUAL,2014-08,,2014-08-31,2023-01,2023-01-31,2024-01,ESTIMATED,2024-01-31,2024-01,ESTIMATED,2024-01-31,,INTERVENTIONAL,,,Ovulation Incidence in Oral Contraceptive Users,Ovulation Incidence in Oral Contraceptive Users,SUSPENDED,,PHASE3,58.0,ESTIMATED,University of Southern California,,2.0,,Investigator leave of absence,f,,,,f,,,,,,,,,,,NO,,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,OTHER,,,,,,,2024,0.0
NCT04564833,,2020-09-21,2023-12-07,,2024-04-11,2020-09-21,2020-09-25,ACTUAL,2024-01-12,2024-01-16,ACTUAL,,,,2024-04-11,2024-04-15,ACTUAL,2021-08-04,ACTUAL,2021-08-04,2024-04,2024-04-30,2023-02-03,ACTUAL,2023-02-03,2022-11-09,ACTUAL,2022-11-09,,INTERVENTIONAL,START,,Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery,"A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery (The START Study)",COMPLETED,,PHASE2,152.0,ACTUAL,"Renibus Therapeutics, Inc.",,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,INDUSTRY,,,,,,,2023,1.0
NCT04495374,,2020-07-24,2021-01-20,,2021-02-11,2020-07-29,2020-07-31,ACTUAL,2021-02-11,2021-03-04,ACTUAL,,,,2021-02-11,2021-03-04,ACTUAL,2019-09-02,ACTUAL,2019-09-02,2021-02,2021-02-28,2020-09-30,ACTUAL,2020-09-30,2020-09-09,ACTUAL,2020-09-09,,INTERVENTIONAL,,,Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy,Use of Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy: Evaluation of Postoperative Pain and Opioid Consumption,TERMINATED,,PHASE4,58.0,ACTUAL,Universidade Federal de Alfenas,"Failure to monitor patients 24 hours after surgery to assess parameters such as chronic pain and home opioid consumption. All patients admitted to the study underwent abdominal hysterectomy, a surgery known to have higher pain rates, which makes it impossible for the results found to be used as a basis for patients undergoing laparoscopic hysterectomy or other types of surgery.",2.0,,Due to an atypical health scenario caused by the COVID-19 pandemic,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,OTHER,,,,,,,2020,0.0
NCT04790786,,2021-02-26,2023-03-14,,2023-05-21,2021-03-08,2021-03-10,ACTUAL,2023-05-21,2023-06-15,ACTUAL,,,,2023-05-21,2023-06-15,ACTUAL,2021-03-10,ACTUAL,2021-03-10,2023-05,2023-05-31,2022-06-16,ACTUAL,2022-06-16,2022-06-16,ACTUAL,2022-06-16,,INTERVENTIONAL,OPTIMISE-C19,,"UPMC OPTIMISE-C19 Trial, a COVID-19 Study",The UPMC OPtimizing Treatment and Impact of Monocolonal antIbodieS Through Evaluation for COVID-19 Trial,TERMINATED,,PHASE4,4571.0,ACTUAL,University of Pittsburgh,"Results are presented before any prespecified statistical trigger was reached. Lack of patient-level variant data limited ability to assess comparative effectiveness relative to variant strains. The EHR eligibility screen identified most, but not all, EUA risk factors and could not identify if a patient was asymptomatic or severely ill. Finally, vaccination status was unable to be ascertained for this cohort which may impact effectiveness of monoclonal antibody therapy.",5.0,,Emergency Use Authorizations for monoclonal antibodies withdrawn,f,,,,t,t,f,,,f,,,Relevant data may be available 1 year following publication,Data access is subject to a methodologically sound proposal and the necessary data sharing agreements.,,YES,"De-identified participant-level data underlying the results reported in journal articles, subject to appropriate security controls, may be available for sharing with other researchers.",2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,OTHER,,,,,,,2022,0.0
NCT03910244,,2019-04-08,,,2024-04-23,2019-04-09,2019-04-10,ACTUAL,,,,,,,2024-04-23,2024-04-25,ACTUAL,2019-10-17,ACTUAL,2019-10-17,2024-04,2024-04-30,2023-09-08,ACTUAL,2023-09-08,2023-09-08,ACTUAL,2023-09-08,,INTERVENTIONAL,PATH-HHT,,Pomalidomide for the Treatment of Bleeding in HHT,Pomalidomide for the Treatment of Bleeding in Hereditary Hemorrhagic Telangiectasia,COMPLETED,,PHASE2,145.0,ACTUAL,The Cleveland Clinic,,2.0,,,f,,,,t,t,f,,,,,,Data will be made available to investigators 6 months after closed data sets for the trial have been prepared for final analysis or 1 month after results of the protocol are published in a peer-reviewed journal.,"A data request form will be developed to collect information deemed necessary by the SC and NIH, including applicant name, organization, and purpose of research. Investigators will submit the request form, Data Distribution Agreement, and IRB approval to designated DCC staff. The SC or its designated Committee will review each application, and if the requestor meets established criteria for access to the data and provides the required documents, the requested data sets and associated documentation will be disseminated by a mode agreed upon by the SC in accordance with NHLBI policy.",,YES,"The DCC will prepare de-identified data files for sharing. A final data sharing plan will be developed with NHLBI and the study Steering Committee. The data can be provided in SAS data sets and export files and documentation will be in PDF format.~The first level of data sharing will be with trial investigators. In addition, the DCC will be responsible for sharing study data with outside researchers, if approved by NHLBI and the SC.",2024-10-15 12:48:38.728869,2024-10-15 12:48:38.728869,OTHER,,,,,,,2023,1.0
NCT02650713,,2016-01-06,,,2020-02-10,2016-01-06,2016-01-08,ESTIMATED,,,,,,,2020-02-10,2020-02-12,ACTUAL,2016-01-07,ACTUAL,2016-01-07,2020-02,2020-02-29,2020-01-13,ACTUAL,2020-01-13,2020-01-13,ACTUAL,2020-01-13,,INTERVENTIONAL,,,"A Study of the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen (CEA)-Positive Solid Tumors","An Open-Label, Multicenter, Dose Escalation and Expansion Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors",COMPLETED,,PHASE1,228.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,INDUSTRY,,,,,,,2020,1.0
NCT04476992,,2020-07-16,,,2023-01-24,2020-07-16,2020-07-20,ACTUAL,,,,,,,2023-01-24,2023-01-26,ACTUAL,2020-07-24,ACTUAL,2020-07-24,2022-04,2022-04-30,2021-09-17,ACTUAL,2021-09-17,2021-07-17,ACTUAL,2021-07-17,,INTERVENTIONAL,NICOR,,Nitric Oxide Therapy for COVID-19 Patients With Oxygen Requirement,A Safety Study on the Use of Intermittent Versus Continuous Inhalation of NO in Spontaneous Breathing COVID-19 Patients,COMPLETED,,PHASE1/PHASE2,20.0,ACTUAL,Tomsk National Research Medical Center of the Russian Academy of Sciences,,2.0,,,f,,,,,f,f,,,f,,,,,,,,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,OTHER,,,,,,,2021,1.0
NCT02294357,,2014-11-10,,,2023-10-30,2014-11-14,2014-11-19,ESTIMATED,,,,,,,2023-10-30,2023-11-01,ACTUAL,2014-12,,2014-12-31,2023-10,2023-10-31,2020-09-22,ACTUAL,2020-09-22,2020-09-21,ACTUAL,2020-09-21,,INTERVENTIONAL,,,Weekly 70 mg/m2 Carfilzomib for Multiple Myeloma Patients Refractory to 27 mg/m2 Carfilzomib,A Phase 2 Study of Weekly 70 mg/m2 Carfilzomib for Multiple Myeloma Patients Refractory to 27 mg/m2 Carfilzomib,TERMINATED,,PHASE2,45.0,ESTIMATED,Oncotherapeutics,,5.0,,Early termination due to the difficulties to enroll subjects.,f,,,,f,,,,,,,,,,,NO,Demographics and Clinical Responses,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,INDUSTRY,,,,,,,2020,0.0
NCT03836053,,2019-02-05,2023-03-28,,2023-03-28,2019-02-08,2019-02-11,ACTUAL,2023-03-28,2024-01-05,ACTUAL,,,,2023-03-28,2024-01-05,ACTUAL,2019-03-04,ACTUAL,2019-03-04,2023-03,2023-03-31,2022-04-21,ACTUAL,2022-04-21,2022-04-21,ACTUAL,2022-04-21,,INTERVENTIONAL,AMG420,Safety analysis set includes all participants who enrolled and received at least 1 dose of AMG 420.,Assessment of AMG 420 in Subjects With Relapsed and/or Refractory Multiple Myeloma,"A Phase 1b Multicenter, Open-label, Expansion Study to Assess the Safety and Efficacy of AMG 420 as Monotherapy in Subjects With Relapsed and/or Refractory Multiple Myeloma",TERMINATED,,PHASE1,23.0,ACTUAL,Amgen,The study was terminated early due to sponsor decision and long-term follow-up was cancelled.,1.0,,Amgen re-evaluated the portfolio and decided to discontinue clinical development activities for AMG 420.,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,INDUSTRY,,,,,,,2022,0.0
NCT02508311,,2015-07-15,2023-03-02,,2024-04-12,2015-07-22,2015-07-24,ESTIMATED,2024-04-12,2024-05-07,ACTUAL,,,,2024-04-12,2024-05-07,ACTUAL,2016-06-01,ACTUAL,2016-06-01,2024-04,2024-04-30,2023-02-28,ACTUAL,2023-02-28,2022-03-02,ACTUAL,2022-03-02,,INTERVENTIONAL,,"9 participants screened, 1 participant was eligible; however, the participant withdrew. No data collected.",Albuterol to Improve Respiratory Strength in SCI,The Effect of an Oral Beta-2 Agonist on Respiratory Muscle Strength in SCI,TERMINATED,,PHASE4,1.0,ACTUAL,VA Office of Research and Development,Inability to perform study during COVID-19. Albuterol repetabs are also no longer being manufactured.,2.0,,Our ability to test subjects with tetraplegia in this interventional study was interrupted by the COVID-19 pandemic. Our research pharmacist also informed us that oral albuterol is no longer being manufactured.,f,,,,f,t,f,,,f,,,,,,NO,IPD data is not available at this time.,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,FED,,,,,,,2023,0.0
NCT04344951,,2020-04-06,,,2021-09-16,2020-04-09,2020-04-14,ACTUAL,,,,,,,2021-09-16,2021-09-23,ACTUAL,2020-04-06,ACTUAL,2020-04-06,2021-09,2021-09-30,2020-11-30,ACTUAL,2020-11-30,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,HOPE,,"Chloroquine Phosphate Against Infection by the Novel Coronavirus SARS-CoV-2 (COVID-19): The HOPE Open-Label, Non Randomized Clinical Trial","Chloroquine Phosphate Against Infection by the Novel Coronavirus SARS-CoV-2 (COVID-19): The HOPE Open-Label, Non Randomized Clinical Trial",TERMINATED,,PHASE2,29.0,ACTUAL,Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.,,1.0,,No clinical efficacy against SARS-CoV-2 recorded,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,INDUSTRY,,,,,,,2020,0.0
NCT03527316,,2018-05-04,,,2022-01-17,2018-05-04,2018-05-17,ACTUAL,,,,,,,2022-01-17,2022-01-19,ACTUAL,2019-10-18,ACTUAL,2019-10-18,2022-01,2022-01-31,2020-12-24,ACTUAL,2020-12-24,2020-12-10,ACTUAL,2020-12-10,,INTERVENTIONAL,MFE,,Effect of Methylenedioxymethamphetamine (MDMA) (Serotonin Release) on Fear Extinction,Effect of MDMA (Serotonin Release) on Fear Extinction,COMPLETED,,EARLY_PHASE1,30.0,ACTUAL,"University Hospital, Basel, Switzerland",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 09:22:51.538102,2024-10-16 09:22:51.538102,OTHER,,,,,,,2020,1.0
NCT03906058,,2019-04-05,,,2023-10-22,2019-04-05,2019-04-08,ACTUAL,,,,,,,2023-10-22,2023-10-25,ACTUAL,2019-04-29,ACTUAL,2019-04-29,2023-10,2023-10-31,2022-04-30,ACTUAL,2022-04-30,2021-02-27,ACTUAL,2021-02-27,,INTERVENTIONAL,,,Anlotinib in Recurrent or Metastatic Nasopharyngeal Carcinoma Patients After Failure of no Less Than Second-line Therapy,"Open-Label, Phase Ⅱ Study of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of no Less Than Second-line Chemotherapy or Targeted Therapy",COMPLETED,,PHASE2,39.0,ACTUAL,Sun Yat-sen University,,1.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,OTHER,,,,,,,2022,1.0
NCT02660944,,2016-01-16,2020-12-01,,2021-03-09,2016-01-16,2016-01-21,ESTIMATED,2021-03-09,2021-03-10,ACTUAL,,,,2021-03-09,2021-03-10,ACTUAL,2016-01-03,ACTUAL,2016-01-03,2021-03,2021-03-31,2020-08-10,ACTUAL,2020-08-10,2020-05-28,ACTUAL,2020-05-28,,INTERVENTIONAL,,All participants who received at least one dose of study treatment,A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE),"A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)",COMPLETED,,PHASE2,64.0,ACTUAL,Resolve Therapeutics,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,INDUSTRY,,,,,,,2020,1.0
NCT05177718,,2021-12-13,2024-03-11,,2024-04-17,2021-12-29,2022-01-05,ACTUAL,2024-04-17,2024-04-18,ACTUAL,,,,2024-04-17,2024-04-18,ACTUAL,2022-09-16,ACTUAL,2022-09-16,2024-04,2024-04-30,2023-04-05,ACTUAL,2023-04-05,2023-04-05,ACTUAL,2023-04-05,,INTERVENTIONAL,,,Natalizumab and Chronic Inflammation,Assessing the Effect of Natalizumab of Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability and Myelin Integrity,TERMINATED,,PHASE4,1.0,ACTUAL,Vanderbilt University Medical Center,,1.0,,Sponsor declined further support,f,,,,t,t,f,,,f,,,\[per PDBP policy\],\[per PDBP policy\],https://pdbp.ninds.nih.gov/policy,YES,Upon reasonable request from qualified investigators the PI will release all data listed below.,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,OTHER,,,,,,,2023,0.0
NCT04040127,,2019-07-30,,,2020-07-23,2019-07-30,2019-07-31,ACTUAL,,,,,,,2020-07-23,2020-07-27,ACTUAL,2019-09-01,ESTIMATED,2019-09-01,2020-07,2020-07-31,2020-02-28,ESTIMATED,2020-02-28,2020-01-15,ESTIMATED,2020-01-15,,INTERVENTIONAL,,,Residual Dental Pulp Tissue and Cord Blood Stem Cells,Effect of Residual Dental Pulp Tissue and Cord Blood Stem Cells on Regeneration of Dental,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, San Francisco",,2.0,,Did not obtain IRB approval,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,OTHER,,,,,,,2020,0.0
NCT04504045,,2020-07-29,,,2022-06-14,2020-08-06,2020-08-07,ACTUAL,,,,,,,2022-06-14,2022-06-16,ACTUAL,2020-09-01,ACTUAL,2020-09-01,2022-06,2022-06-30,2022-05-10,ACTUAL,2022-05-10,2022-05-10,ACTUAL,2022-05-10,,INTERVENTIONAL,,,Metformin's Effect on Drug Metabolism in Patients With Type 2 Diabetes,INFLAMMATION AND DRUG METABOLISM - Does the Effect of Drugs Decrease When Patients With Type 2 Diabetes Initiate Antidiabetic Treatment?,TERMINATED,,PHASE1,10.0,ACTUAL,University of Southern Denmark,,1.0,,"Slow recruitment due to COVID-19, the study was stopped when recruited numbers fulfilled the pre-defined lower sample size.",f,,,,t,f,f,,,,,,,,,NO,Individual participant data cannot be shared due to general data protection regulation (GDPR).,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,OTHER,,,,,,,2022,0.0
NCT03376932,,2017-12-01,,,2019-03-22,2017-12-13,2017-12-19,ACTUAL,,,,,,,2019-03-22,2019-03-25,ACTUAL,2019-01-18,ESTIMATED,2019-01-18,2019-03,2019-03-31,2021-02-03,ESTIMATED,2021-02-03,2021-02-03,ESTIMATED,2021-02-03,,INTERVENTIONAL,,,Effectiveness of Fluticasone Furoate/ Umeclidinium/ Vilanterol (FF/UMEC/VI) Using the Connected Inhaler System (CIS) as Compared With Fluticasone Proprionate/ Salmeterol (FP/SAL) Plus Tiotropium (TIO) in Inadequately Controlled Asthma,A Randomised Open-label Study to Compare the Effectiveness of the Fixed Dose Combination of FF/UMEC/VI (Using the Connected Inhaler System) With the Combination of FP/SAL Plus Tiotropium (Without the Connected Inhaler System) in Participants With Inadequately Controlled Asthma,WITHDRAWN,,PHASE3,0.0,ACTUAL,GlaxoSmithKline,,4.0,,withdrawn due to internal reasons,f,,,,f,t,t,,,,,,IPD will be made available within 6 months of publishing the results of the primary endpoints of the study,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,INDUSTRY,,,,,,,2021,0.0
NCT04419493,,2020-06-04,2022-06-20,,2023-04-25,2020-06-04,2020-06-05,ACTUAL,2023-04-25,2023-04-26,ACTUAL,,,,2023-04-25,2023-04-26,ACTUAL,2020-06-23,ACTUAL,2020-06-23,2023-04,2023-04-30,2021-06-21,ACTUAL,2021-06-21,2021-06-21,ACTUAL,2021-06-21,,INTERVENTIONAL,,Treated set - part A (TS-A) included all subjects who were randomised and treated with at least 1 dose of the investigational medicinal product.~Treated set - part B (TS-B) included all subjects who had been randomised and treated with at least 1 dose of the investigational medicinal product.,A Study in Healthy Men to Compare 2 Different Formulations of Alteplase,Bioequivalence of Alteplase Derived From Two Different Manufacturing Processes Following Intravenous Administration in Healthy Male Volunteers,COMPLETED,,PHASE1,30.0,ACTUAL,Boehringer Ingelheim,"For study Part A three subjects underwent only one treatment period, thereafter the trial was put on-hold. Trial Part B was performed as planned. There were no important protocol deviations (IPDs). Each entered subject met all of the inclusion criteria and none of the exclusion criteria.",4.0,,,f,,,,,f,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,INDUSTRY,,,,,,,2021,1.0
NCT03510455,,2018-04-26,2021-02-16,,2021-03-15,2018-04-26,2018-04-27,ACTUAL,2021-03-15,2021-04-08,ACTUAL,,,,2021-03-15,2021-04-08,ACTUAL,2019-02-27,ACTUAL,2019-02-27,2020-05,2020-05-31,2020-05-04,ACTUAL,2020-05-04,2020-02-28,ACTUAL,2020-02-28,,INTERVENTIONAL,,,BGJ398 for the Treatment of Tumor-Induced Osteomalacia,BGJ398 for the Treatment of Tumor-Induced Osteomalacia,TERMINATED,,PHASE2,4.0,ACTUAL,National Institutes of Health Clinical Center (CC),"This study was terminated early due to a lack of efficacy in the first 4 patients and an unexpectedly high rate of ocular adverse events. As a result, only 4 patients were enrolled in this study. Because of the small sample size, we were unable to perform the planned statistical analysis, and instead the results are primarily descriptive.",1.0,,Study was stopped early due to a greater than expected incidence of ocular AEs and analysis of the data from the first 4 subjects indicating that the likelihood of permanent remission with this therapy was low.,f,,,,,t,f,,,,,,,,,,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,NIH,,,,,,,2020,0.0
NCT02914938,,2016-09-12,,,2023-05-05,2016-09-23,2016-09-26,ESTIMATED,,,,,,,2023-05-05,2023-05-09,ACTUAL,2016-10,,2016-10-31,2022-12,2022-12-31,2023-03-29,ACTUAL,2023-03-29,2023-03-29,ACTUAL,2023-03-29,,INTERVENTIONAL,,,"A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma","A Three-Arm Study of ME-401 Monotherapy in Subjects With Relapsed/Refractory CLL, SLL, or FL, of ME-401 in Combination With Rituximab in Subjects With Relapsed/Refractory CLL/SLL or B-cell NHL, and of ME-401 in Combination With Zanubrutinib in Subjects With Relapsed/Refractory CLL/SLL or B-cell NHL",TERMINATED,,PHASE1,97.0,ACTUAL,"MEI Pharma, Inc.",,3.0,,discontinuation of zandelisib program,f,,,,f,,,,,,,,,,,,,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,INDUSTRY,,,,,,,2023,0.0
NCT02968849,,2016-11-01,2022-11-16,,2024-07-10,2016-11-16,2016-11-21,ESTIMATED,2023-01-13,2023-02-08,ACTUAL,,,,2024-07-10,2024-07-22,ACTUAL,2016-10-26,ACTUAL,2016-10-26,2023-12,2023-12-31,2021-11-16,ACTUAL,2021-11-16,2021-11-16,ACTUAL,2021-11-16,,INTERVENTIONAL,HVTN702,Safety Cohort,Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa,"A Pivotal Phase 2b/3 Multisite, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120/MF59 in Preventing HIV-1 Infection in Adults in South Africa",COMPLETED,,PHASE2/PHASE3,5404.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,t,t,,,,t,,,,,,NO,,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,NIH,,,,,,,2021,1.0
NCT04373044,,2020-04-17,,,2021-05-21,2020-04-30,2020-05-04,ACTUAL,,,,,,,2021-05-21,2021-05-26,ACTUAL,2020-05-01,ACTUAL,2020-05-01,2021-05,2021-05-31,2021-05-12,ACTUAL,2021-05-12,2021-05-12,ACTUAL,2021-05-12,,INTERVENTIONAL,,,"Baricitinib, Placebo and Antiviral Therapy for the Treatment of Patients With Moderate and Severe COVID-19",A Phase II Randomized Double-Blind Trial of Baricitinib or Placebo Combined With Antiviral Therapy in Patients With Moderate and Severe COVID-19,TERMINATED,,PHASE2,6.0,ACTUAL,University of Southern California,,2.0,,The study was terminated after the release of results of ACTT-2 (NCT04401579).,,,,,t,t,f,,,f,,,,,,,,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,OTHER,,,,,,,2021,0.0
NCT03721172,,2018-10-09,2021-04-26,2020-11-04,2024-05-10,2018-10-24,2018-10-26,ACTUAL,2021-04-26,2021-05-17,ACTUAL,2020-11-04,2020-11-06,ACTUAL,2024-05-10,2024-05-29,ACTUAL,2019-03-11,ACTUAL,2019-03-11,2024-05,2024-05-31,2020-07-24,ACTUAL,2020-07-24,2020-03-06,ACTUAL,2020-03-06,,INTERVENTIONAL,ADVANCE,,Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy,"A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Mild to Moderate Plaque Psoriasis",COMPLETED,,PHASE3,595.0,ACTUAL,Amgen,,3.0,,,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,INDUSTRY,,,,,,,2020,1.0
NCT04954326,,2021-06-18,2023-05-17,,2023-07-10,2021-06-29,2021-07-08,ACTUAL,2023-06-14,2023-07-05,ACTUAL,,,,2023-07-10,2023-07-12,ACTUAL,2021-05-07,ACTUAL,2021-05-07,2023-07,2023-07-31,2022-05-20,ACTUAL,2022-05-20,2022-05-20,ACTUAL,2022-05-20,,INTERVENTIONAL,ALL,"One patient in the S95014 liquid (LIQ) group was prematurely withdrawn from the study on the day of randomization due to a major deviation/protocol violation (patient with B-cell Burkitt Acute Lymphoblastic Leukemia) and did not receive the study treatment. Another patient who was randomized in the lyophilizate (LYO) group but received the LIQ formulation in error, was analyzed according to the treatment actually received, LIQ, and counted here under LIQ.",A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL),"A Multicentre, Phase II Randomized Study, Open-label, With 2-arm Parallel Group, Comparing the Pharmacokinetics of the Liquid and the Lyophilized Formulations of Pegaspargase (S95014) in Treatment of Paediatric Patients With Newly-Diagnosed Acute Lymphoblastic Leukemia (ALL)",COMPLETED,,PHASE2,89.0,ACTUAL,Servier,,2.0,,,f,,,,f,t,f,,,,,,After Marketing Authorisation in EEA or US if the study is used for the approval.,Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.,https://clinicaltrials.servier.com/,YES,"Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.",2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,INDUSTRY,,,,,,,2022,1.0
NCT04655157,,2020-12-03,2023-08-07,,2024-04-25,2020-12-03,2020-12-07,ACTUAL,2024-04-25,2024-05-23,ACTUAL,,,,2024-04-25,2024-05-23,ACTUAL,2021-05-28,ACTUAL,2021-05-28,2024-04,2024-04-30,2022-09-20,ACTUAL,2022-09-20,2022-08-03,ACTUAL,2022-08-03,,INTERVENTIONAL,QUAD01,,Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimuma,A Multi-Center Phase I/II Open Label Study to Evaluate Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimumab. (QUAD 01: Quadruple Therapy in Melanoma),TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,University of Pittsburgh,,2.0,,Study terminated due to slow enrollment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,OTHER,,,,,,,2022,0.0
NCT02980276,,2016-11-09,,,2023-08-11,2016-11-29,2016-12-02,ESTIMATED,,,,,,,2023-08-11,2023-08-14,ACTUAL,2017-06-06,ACTUAL,2017-06-06,2023-08,2023-08-31,2023-04-13,ACTUAL,2023-04-13,2023-01-12,ACTUAL,2023-01-12,,INTERVENTIONAL,EMERGE,,A Randomized Placebo Controlled Trial of the Effectiveness of Metformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects,A Randomised Placebo Controlled Trial of the Effectiveness of Early MEtformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects (EMERGE),COMPLETED,,PHASE3,535.0,ACTUAL,"National University of Ireland, Galway, Ireland",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,OTHER,,,,,,,2023,0.0
NCT03834519,,2019-02-06,2023-03-02,,2024-01-31,2019-02-06,2019-02-08,ACTUAL,2023-04-18,2023-04-20,ACTUAL,,,,2024-01-31,2024-02-02,ACTUAL,2019-05-02,ACTUAL,2019-05-02,2024-01,2024-01-31,2024-01-27,ACTUAL,2024-01-27,2022-03-14,ACTUAL,2022-03-14,,INTERVENTIONAL,KEYLYNK-010,,Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010),"A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment With One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)",COMPLETED,,PHASE3,793.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,INDUSTRY,,,,,,,2024,1.0
NCT04363840,,2020-04-24,,,2021-12-07,2020-04-24,2020-04-27,ACTUAL,,,,,,,2021-12-07,2021-12-27,ACTUAL,2020-05,ESTIMATED,2020-05-31,2021-12,2021-12-31,2020-12,ESTIMATED,2020-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,LEAD COVID-19,,"The LEAD COVID-19 Trial: Low-risk, Early Aspirin and Vitamin D to Reduce COVID-19 Hospitalizations","The LEAD COVID-19 Trial: Low-risk, Early Aspirin and Vitamin D to Reduce COVID-19 Hospitalizations",WITHDRAWN,,PHASE2,0.0,ACTUAL,Louisiana State University Health Sciences Center in New Orleans,,3.0,,lack of funding,f,,,,,t,f,,,t,,,,,,,,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,OTHER,,,,,,,2020,0.0
NCT03205891,,2017-06-29,,,2018-01-12,2017-06-29,2017-07-02,ACTUAL,,,,,,,2018-01-12,2018-01-17,ACTUAL,2018-03,ESTIMATED,2018-03-31,2018-01,2018-01-31,2021-03,ESTIMATED,2021-03-31,2021-03,ESTIMATED,2021-03-31,,INTERVENTIONAL,,,"Study of Brentuximab Vedotin Plus TAK228 for Relapsed/Refractory Classical Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma and Other CD30+Peripheral T-Cell Lymphomas","An Open Label Phase I Study of Brentuximab Vedotin Plus TAK228 for Patients With Relapsed/Refractory Classical Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma and Other CD30+Peripheral T-Cell Lymphomas",WITHDRAWN,,PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Change in treatment priorities for these disease types as well as staffing concerns.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,OTHER,,,,,,,2021,0.0
NCT03238963,,2017-08-01,2021-05-11,,2021-05-11,2017-08-01,2017-08-03,ACTUAL,2021-05-11,2021-06-04,ACTUAL,,,,2021-05-11,2021-06-04,ACTUAL,2017-09-19,ACTUAL,2017-09-19,2021-03,2021-03-31,2020-05-14,ACTUAL,2020-05-14,2020-05-14,ACTUAL,2020-05-14,,INTERVENTIONAL,ROBIN,Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).,"A Study That Tests BI 1467335 in Patients With Diabetic Eye Disease (Diabetic Retinopathy). It Looks at the Way BI 1467335 is Taken up, the Effects it Has, and How Well it is Tolerated.","A Randomized, Double-masked, Placebo-controlled Exploratory Study to Evaluate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Orally Administered BI 1467335 for 12 Weeks With a 12 Week Follow up Period in Patients With Non-proliferative Diabetic Retinopathy Without Center-involved Diabetic Macular Edema (ROBIN Study)",COMPLETED,,PHASE2,79.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,INDUSTRY,,,,,,,2020,1.0
NCT04931511,,2021-04-08,,,2023-12-21,2021-06-17,2021-06-18,ACTUAL,,,,,,,2023-12-21,2023-12-29,ACTUAL,2021-06-01,ACTUAL,2021-06-01,2023-12,2023-12-31,2022-09-01,ACTUAL,2022-09-01,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,,,Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder,Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder: a Randomized Double Blind Study,TERMINATED,,PHASE4,20.0,ACTUAL,"Second Affiliated Hospital, School of Medicine, Zhejiang University",,2.0,,"Since the COVID-19 pendemic, the regular follow-up of participant became very hard. The participant were not willing to go back to the hospital for repeat measurement. So we stop the study and plan to redesign the protocol.",f,,,,t,f,f,,,,,,I'd like to share the IPD with the other researchers after the paper is published.,,,YES,I'd like to share the IPD with the other researchers after the paper is published.,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,OTHER,,,,,,,2022,0.0
NCT03400943,,2018-01-05,2021-03-23,2020-03-17,2023-04-28,2018-01-15,2018-01-17,ACTUAL,2021-06-09,2021-06-11,ACTUAL,2021-06-09,2021-06-11,ACTUAL,2023-04-28,2023-05-03,ACTUAL,2018-01-17,ACTUAL,2018-01-17,2023-04,2023-04-30,2022-04-06,ACTUAL,2022-04-06,2019-06-09,ACTUAL,2019-06-09,,INTERVENTIONAL,,"SAF consisted of all randomized participants in FAS who took at least 1 dose of study drug. The discrepancy of group B1 and B2 between subject dispostion and baseline characteristics was caused by mistakes in the administration of study drug.~Three participants who were assigned to B1, erroneously received vilaprisan treatment instead of placebo in Treatment Period (TP) 1. Two participants who were assigned to B1, erroneously received placebo instead of vilaprisan in TP2.",Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3),"A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",TERMINATED,,PHASE3,93.0,ACTUAL,Bayer,,4.0,,"Due to a change in the development program, the study was closed prematurely.",f,,,,f,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,INDUSTRY,,,,,,,2022,0.0
NCT04883138,,2021-05-04,,,2022-01-11,2021-05-10,2021-05-12,ACTUAL,,,,,,,2022-01-11,2022-01-26,ACTUAL,2021-05-24,ACTUAL,2021-05-24,2022-01,2022-01-31,2022-01-11,ACTUAL,2022-01-11,2022-01-11,ACTUAL,2022-01-11,,INTERVENTIONAL,,,Recombinant Hyperimmune Polyclonal Antibody (GIGA-2050) in COVID-19 Patients,A Phase 1 Single Ascending Dose Study of a Recombinant Hyperimmune Polyclonal Antibody Against SARS CoV-2 (GIGA-2050) in Patients Hospitalized With COVID-19,TERMINATED,,PHASE1,3.0,ACTUAL,"GigaGen, Inc.",,3.0,,Study stopped for commercial reasons.,f,,,,f,t,f,,,,,,,,,NO,No current plan to share IPD due to evaluation of potential DLTs.,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,INDUSTRY,,,,,,,2022,0.0
NCT03119766,,2017-04-04,2021-11-22,,2022-06-02,2017-04-13,2017-04-19,ACTUAL,2022-06-02,2022-06-07,ACTUAL,,,,2022-06-02,2022-06-07,ACTUAL,2017-06-28,ACTUAL,2017-06-28,2019-06,2019-06-30,2020-01-11,ACTUAL,2020-01-11,2020-01-11,ACTUAL,2020-01-11,,INTERVENTIONAL,,"The study will enroll the subjects of either gender aged 18-45 years old with verified diagnosis of functional dyspepsia according to Rome-IV criteria, intensity of dyspeptic symptoms ≥ 6 according to GIS and negative H. pylori test.",Clinical Trial of Efficacy and Safety of Kolofort in Functional Dyspepsia Patients,Multicenter Double-blind Placebo-controlled Randomized Clinical Trial of Efficacy and Safety of Kolofort in the Treatment of Patients With Functional Dyspepsia,COMPLETED,,PHASE4,370.0,ACTUAL,Materia Medica Holding,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,INDUSTRY,,,,,,,2020,1.0
NCT04596995,,2020-10-15,2023-12-20,,2024-02-02,2020-10-15,2020-10-22,ACTUAL,2024-02-02,2024-02-05,ACTUAL,,,,2024-02-02,2024-02-05,ACTUAL,2021-01-06,ACTUAL,2021-01-06,2024-01,2024-01-31,2022-12-21,ACTUAL,2022-12-21,2022-12-21,ACTUAL,2022-12-21,,INTERVENTIONAL,myOpportunITy3,Baseline Characteristics refer to Enrolled Set which consisted of all study participants who signed the informed consent form (ICF).,"A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)","An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)",TERMINATED,,PHASE3,43.0,ACTUAL,UCB Pharma,,1.0,,Strategic Business Decision; Not a safety decision,f,,,,t,t,f,,,f,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",https://www.vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,INDUSTRY,,,,,,,2022,0.0
NCT03365752,,2017-11-27,2021-05-04,,2022-04-19,2017-12-03,2017-12-07,ACTUAL,2022-04-19,2022-04-20,ACTUAL,,,,2022-04-19,2022-04-20,ACTUAL,2018-06-24,ACTUAL,2018-06-24,2022-04,2022-04-30,2021-02-04,ACTUAL,2021-02-04,2021-02-04,ACTUAL,2021-02-04,,INTERVENTIONAL,,,Chloroprocaine Spinal for Outpatient Knee Surgery,"A Comparison Study to Facilitate Earlier Discharge: Spinal Versus General Anesthesia for Outpatient Knee Surgeries, a Randomized Controlled Study",TERMINATED,,PHASE2,39.0,ACTUAL,"Hospital for Special Surgery, New York","This project was terminated early, as enrollment was negatively impacted to due to the COVID-19 pandemic and because clinical practice has shifted to include the use of chloroprocaine in spinal procedures as standard of care at the Hospital for Special Surgery.",3.0,,Study halted due to COVID-19 pandemic and terminated early per request of principal investigator as Chloroprocaine use in spinal procedures has become incorporated as standard of care at HSS.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,OTHER,,,,,,,2021,0.0
NCT02612311,,2015-11-18,2024-03-04,,2024-04-10,2015-11-19,2015-11-23,ESTIMATED,2024-04-10,2024-05-07,ACTUAL,,,,2024-04-10,2024-05-07,ACTUAL,2015-11-19,ACTUAL,2015-11-19,2024-04,2024-04-30,2023-02-22,ACTUAL,2023-02-22,2023-02-22,ACTUAL,2023-02-22,,INTERVENTIONAL,UNITY-CLL,"The Intent-to-Treat (ITT) population included all randomized participants, regardless of administration of study treatment (ublituximab, TGR-1202, obinutuzumab + chlorambucil, or ublituximab + TGR-1202).",Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia,"Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With TGR-1202 (Umbralisib) Compared to Obinutuzumab in Combination With Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)",TERMINATED,,PHASE3,603.0,ACTUAL,"TG Therapeutics, Inc.","Due to sponsor's business decision, the clinical trial was terminated by the sponsor prematurely. As such, the study results are reflective of the data captured to the time of study termination and with limited data verification.",4.0,,Strategic/Business decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,INDUSTRY,,,,,,,2023,0.0
NCT04362813,,2020-04-24,2021-07-30,2021-02-08,2022-01-21,2020-04-24,2020-04-27,ACTUAL,2021-08-12,2021-08-16,ACTUAL,2021-08-12,2021-08-16,ACTUAL,2022-01-21,2022-01-24,ACTUAL,2020-04-30,ACTUAL,2020-04-30,2022-01,2022-01-31,2020-12-22,ACTUAL,2020-12-22,2020-09-16,ACTUAL,2020-09-16,,INTERVENTIONAL,CAN-COVID,"While patient flow and baseline measure tables show 454 participants enrolled, only 451 randomized. 3 were mis-randomized i.e. assigned a randomization number in error and not treated.",Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia,"Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Canakinumab on Cytokine Release Syndrome in Patients With COVID-19-induced Pneumonia (CAN-COVID)",COMPLETED,,PHASE3,454.0,ACTUAL,Novartis,,2.0,,,,,,,t,t,f,,,,,,,,,UNDECIDED,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 09:22:51.538102,2024-10-16 09:22:51.538102,INDUSTRY,,,,,,,2020,1.0
NCT03890198,,2019-03-17,,,2020-06-30,2019-03-24,2019-03-26,ACTUAL,,,,,,,2020-06-30,2020-07-02,ACTUAL,2019-04-22,ACTUAL,2019-04-22,2020-06,2020-06-30,2020-03-06,ACTUAL,2020-03-06,2020-03-06,ACTUAL,2020-03-06,,INTERVENTIONAL,,,A Phase 1 Study of LCAR-C182A Cells in the Treatment of Advanced Gastric Cancer and Pancreatic Ductal Adenocarcinoma,"A Phase 1, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of LCAR-C182A, an Anti-Claudin18.2 CAR-T Cell Therapy in Patients With Advanced Gastric Cancer and Pancreatic Ductal Adenocarcinoma",TERMINATED,,EARLY_PHASE1,2.0,ACTUAL,First Affiliated Hospital Xi'an Jiaotong University,,1.0,,"the Preliminary data, progress of this study and the adjustment of the pipeline and strategy .",f,,,,f,f,f,,,,,,,,,,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,OTHER,,,,,,,2020,0.0
NCT04598477,,2020-10-08,,,2024-04-23,2020-10-16,2020-10-22,ACTUAL,,,,,,,2024-04-23,2024-04-24,ACTUAL,2021-07-15,ACTUAL,2021-07-15,2024-04,2024-04-30,2024-03-25,ACTUAL,2024-03-25,2024-03-25,ACTUAL,2024-03-25,,INTERVENTIONAL,ADDRESS+,,A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus),"An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Pemphigus",TERMINATED,,PHASE3,183.0,ACTUAL,argenx,,1.0,,"Based on the lack of observed efficacy in the primary study ARGX-113-1904, the sponsor decided to discontinue the open-label extension study.",,,,,t,t,f,,,,,,,,,,,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,INDUSTRY,,,,,,,2024,0.0
NCT05317442,,2022-03-30,,,2024-04-29,2022-03-30,2022-04-07,ACTUAL,,,,,,,2024-04-29,2024-05-01,ACTUAL,2022-04-06,ACTUAL,2022-04-06,2024-04,2024-04-30,2024-04-19,ACTUAL,2024-04-19,2024-04-19,ACTUAL,2024-04-19,,INTERVENTIONAL,,,Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound,Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound,TERMINATED,,PHASE4,10.0,ACTUAL,Taipei Medical University WanFang Hospital,,1.0,,Study halted prematurely and will not resume.,f,,,,f,t,f,,,,,,,,,NO,IIT study,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,OTHER,,,,,,,2024,0.0
NCT02854670,,2016-08-01,,,2022-11-09,2016-08-02,2016-08-03,ESTIMATED,,,,,,,2022-11-09,2022-11-14,ACTUAL,2016-01-20,ACTUAL,2016-01-20,2022-11,2022-11-30,2021-02-03,ACTUAL,2021-02-03,2021-02-03,ACTUAL,2021-02-03,,INTERVENTIONAL,CAPSIVU,,A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia,,TERMINATED,,PHASE2/PHASE3,10.0,ACTUAL,Centre Hospitalier Universitaire de Besancon,,1.0,,Recruitment difficulties,f,,,,t,,,,,,,,,,,NO,,2024-10-16 09:22:51.538102,2024-10-16 09:22:51.538102,OTHER,,,,,,,2021,0.0
NCT02420795,,2015-04-15,2021-11-10,,2022-03-30,2015-04-17,2015-04-20,ESTIMATED,2022-03-30,2022-04-04,ACTUAL,,,,2022-03-30,2022-04-04,ACTUAL,2015-11-03,ACTUAL,2015-11-03,2022-03,2022-03-31,2020-11-16,ACTUAL,2020-11-16,2020-11-16,ACTUAL,2020-11-16,,INTERVENTIONAL,,Patients enrolled on Arm A until Arm B approved in 2/9/2016 IRB amendment,Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma,Phase I/II Study of Oral ONC201 in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma,TERMINATED,,PHASE1/PHASE2,16.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Per PI Request,f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:22:51.538102,2024-10-16 09:22:51.538102,OTHER,,,,,,,2020,0.0
NCT03470350,,2018-02-14,,,2019-07-22,2018-03-12,2018-03-19,ACTUAL,,,,,,,2019-07-22,2019-07-24,ACTUAL,2018-08-24,ESTIMATED,2018-08-24,2019-07,2019-07-31,2020-06-01,ESTIMATED,2020-06-01,2020-06-01,ESTIMATED,2020-06-01,,INTERVENTIONAL,EORTC1615,,Galunisertib and Capecitabine in Advanced Resistant TGF-beta Activated Colorectal Cancer,MoTriColor: Phase I/II Study With Galunisertib (LY2157299) Combined With Capecitabine in Patients With Advanced Chemotherapy Resistant Colorectal Cancer and an Activated TGF-beta Signature,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,The Netherlands Cancer Institute,,1.0,,No study drug available. Same concept with new study drug will be explored in M19TGA study,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,OTHER,,,,,,,2020,0.0
NCT01760525,,2013-01-02,,,2021-06-10,2013-01-02,2013-01-04,ESTIMATED,,,,,,,2021-06-10,2021-06-15,ACTUAL,2013-03-20,ACTUAL,2013-03-20,2021-06,2021-06-30,2020-07-24,ACTUAL,2020-07-24,2020-07-24,ACTUAL,2020-07-24,,INTERVENTIONAL,CCGM097X2101,,A Phase I Dose Escalation Study of CGM097 in Adult Patients With Selected Advanced Solid Tumors,"A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral CGM097, a p53/HDM2-interaction Inhibitor, in Adult Patients With Selected Advanced Solid Tumors",COMPLETED,,PHASE1,51.0,ACTUAL,Novartis,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,INDUSTRY,,,,,,,2020,1.0
NCT04457336,,2020-06-25,,,2024-06-06,2020-06-30,2020-07-07,ACTUAL,,,,,,,2024-06-06,2024-06-10,ACTUAL,2020-08-26,ACTUAL,2020-08-26,2024-06,2024-06-30,2024-05-23,ACTUAL,2024-05-23,2024-02-09,ACTUAL,2024-02-09,,INTERVENTIONAL,,,A Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAH,"A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects With Classic Congenital Adrenal Hyperplasia",TERMINATED,,PHASE2,96.0,ACTUAL,Spruce Biosciences,,4.0,,Study SPR001-203 did not meet its primary and secondary endpoints therefore Spruce Biosciences has decided to terminate the study,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,INDUSTRY,,,,,,,2024,0.0
NCT02487953,,2015-06-30,,,2018-09-11,2015-07-01,2015-07-02,ESTIMATED,,,,,,,2018-09-11,2018-09-12,ACTUAL,2018-07,ESTIMATED,2018-07-31,2018-09,2018-09-30,2022-01,ESTIMATED,2022-01-31,2020-01,ESTIMATED,2020-01-31,,INTERVENTIONAL,ENDS-P50,,Electronic Nicotine Delivery Systems as a Smoking Cessation Treatment,Electronic Nicotine Delivery Systems (ENDS) as a Smoking Cessation Treatment,WITHDRAWN,,PHASE2,0.0,ACTUAL,Duke University,,3.0,,Study design changed significantly; was submitted as a different protocol.,f,,,,f,t,f,,,t,,,,,,,,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,OTHER,,,,,,,2022,0.0
NCT04972123,,2021-07-12,2024-05-28,,2024-06-25,2021-07-12,2021-07-22,ACTUAL,2024-06-18,2024-06-24,ACTUAL,,,,2024-06-25,2024-07-17,ACTUAL,2021-07-20,ACTUAL,2021-07-20,2024-06,2024-06-30,2023-08-31,ACTUAL,2023-08-31,2023-08-25,ACTUAL,2023-08-25,,INTERVENTIONAL,,Evaluable participants for intention to treat primary endpoint By protocol entry criteria the age range was 18 to 50 Years.,The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope,The Effect of Capsaicin-Phenylephrine-Caffeine Formulation on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope,COMPLETED,,PHASE2,143.0,ACTUAL,"University of Wisconsin, Madison",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,OTHER,,,,,,,2023,1.0
NCT03937141,,2019-04-29,2021-11-11,,2021-12-03,2019-05-02,2019-05-03,ACTUAL,2021-12-03,2022-01-03,ACTUAL,,,,2021-12-03,2022-01-03,ACTUAL,2019-08-26,ACTUAL,2019-08-26,2021-12,2021-12-31,2021-06-10,ACTUAL,2021-06-10,2021-05-10,ACTUAL,2021-05-10,,INTERVENTIONAL,,All participants who received at least one dose of study drug.,Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer,A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults With Head and Neck Cancer,TERMINATED,,PHASE2,16.0,ACTUAL,"Chinook Therapeutics, Inc.",,1.0,,No substantial anti-tumor activity was observed.,f,,,,,t,f,,,,,,,,,,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,INDUSTRY,,,,,,,2021,0.0
NCT01395641,,2011-06-12,,,2023-02-08,2011-07-14,2011-07-15,ESTIMATED,,,,,,,2023-02-08,2023-02-10,ACTUAL,2014-10-22,ACTUAL,2014-10-22,2022-11,2022-11-30,2022-03-07,ACTUAL,2022-03-07,2020-12-18,ACTUAL,2020-12-18,,INTERVENTIONAL,AADC,,A Phase I/II Clinical Trial for Treatment of Aromatic L-amino Acid Decarboxylase (AADC) Deficiency Using AAV2-hAADC,A Phase I/II Clinical Trial for Treatment of Aromatic L-amino Acid Decarboxylase (AADC) Deficiency Using AAV2-hAADC,COMPLETED,,PHASE1/PHASE2,10.0,ACTUAL,National Taiwan University Hospital,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 09:22:51.538102,2024-10-16 09:22:51.538102,OTHER,,,,,,,2022,1.0
NCT03825341,,2019-01-23,2022-02-18,,2022-02-18,2019-01-29,2019-01-31,ACTUAL,2022-02-18,2022-03-18,ACTUAL,,,,2022-02-18,2022-03-18,ACTUAL,2019-06-10,ACTUAL,2019-06-10,2022-02,2022-02-28,2022-01-20,ACTUAL,2022-01-20,2022-01-20,ACTUAL,2022-01-20,,INTERVENTIONAL,,No enrollments on Arm 1.,Hydroxyurea Therapy: Optimizing Access in Pediatric Populations Everywhere,Hydroxyurea Therapy: Optimizing Access in Pediatric Populations Everywhere,TERMINATED,,PHASE2,1.0,ACTUAL,St. Jude Children's Research Hospital,No participants were treated on this study.,2.0,,The study terminated early due to challenges with recruitment during the COVID pandemic.,,,,,t,t,f,,,,,,Data will be made available at the time of article publication.,"Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.",,YES,"Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.",2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,OTHER,,,,,,,2022,0.0
NCT04307186,,2020-03-11,2023-09-04,,2023-10-24,2020-03-11,2020-03-13,ACTUAL,2023-10-24,2023-11-15,ACTUAL,,,,2023-10-24,2023-11-15,ACTUAL,2020-11-18,ACTUAL,2020-11-18,2023-10,2023-10-31,2022-09-06,ACTUAL,2022-09-06,2022-09-05,ACTUAL,2022-09-05,,INTERVENTIONAL,,,Study to Find the Appropriate Dose of a New Gadolinium-based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions,"Multicenter, Single-blind, Adaptive Dose Finding Study of Single Intravenous Injections of BAY 1747846 With Corresponding Blinded Read in Adult Participants With Known or Highly Suspected CNS Lesions Referred for Contrast-enhanced MRI of the CNS",COMPLETED,,PHASE2,57.0,ACTUAL,Bayer,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,INDUSTRY,,,,,,,2022,1.0
NCT03867162,,2019-02-14,,,2023-08-16,2019-03-06,2019-03-07,ACTUAL,,,,,,,2023-08-16,2023-08-21,ACTUAL,2021-06-09,ESTIMATED,2021-06-09,2023-08,2023-08-31,2021-12-17,ACTUAL,2021-12-17,2021-12-17,ACTUAL,2021-12-17,,INTERVENTIONAL,NDBR,,FY15-14: Tularemia Vaccine Protocol (NDBR Lot 4),"Phase 2 Open-Label Safety and Immunogenicity Study of Tularemia Vaccine, Live, Attenuated (NDBR 101, Lot 4) in Adult Subjects at Risk of Exposure to Tularemia Bacteria",WITHDRAWN,,PHASE2,0.0,ACTUAL,U.S. Army Medical Research and Development Command,,1.0,,"Sponsor terminated this protocol on Dec17, 2021; no subjects have been enrolled",f,,,,,t,f,,,,,,,,,NO,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,FED,,,,,,,2021,0.0
NCT02807883,,2016-06-17,2022-10-13,,2022-12-30,2016-06-17,2016-06-21,ESTIMATED,2022-12-30,2023-01-20,ACTUAL,,,,2022-12-30,2023-01-20,ACTUAL,2016-08,ACTUAL,2016-08-31,2022-12,2022-12-31,2022-02-01,ACTUAL,2022-02-01,2022-02-01,ACTUAL,2022-02-01,,INTERVENTIONAL,,,Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia,Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia,COMPLETED,,PHASE2,23.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,OTHER,,,,,,,2022,1.0
NCT04076462,,2019-08-29,,2024-04-24,2024-04-24,2019-08-30,2019-09-03,ACTUAL,,,,,2024-04-25,ACTUAL,2024-04-24,2024-04-25,ACTUAL,2019-08-19,ACTUAL,2019-08-19,2024-04,2024-04-30,2023-05-02,ACTUAL,2023-05-02,2023-05-02,ACTUAL,2023-05-02,,INTERVENTIONAL,ACROINNOVA 1,,A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly,"A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly",COMPLETED,,PHASE3,72.0,ACTUAL,Camurus AB,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,INDUSTRY,,,,,,,2023,1.0
NCT04500418,,2020-08-04,,,2022-03-14,2020-08-04,2020-08-05,ACTUAL,,,,,,,2022-03-14,2022-03-29,ACTUAL,2020-08-25,ACTUAL,2020-08-25,2022-03,2022-03-31,2021-07-27,ACTUAL,2021-07-27,2021-07-27,ACTUAL,2021-07-27,,INTERVENTIONAL,,,Charité Trial of Cenicriviroc (CVC) Treatment for COVID-19 Patients,Charité Trial of Cenicriviroc (CVC) Treatment for COVID-19 Patients,TERMINATED,,PHASE2,45.0,ACTUAL,"Charite University, Berlin, Germany",,2.0,,"Despite multiple efforts, no further patient could be enrolled since 03/05/2021. A continuation of the study is therefore no longer justified",f,,,,t,f,f,,,,,,,,,UNDECIDED,Undecided at this moment. (08/2020),2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,OTHER,,,,,,,2021,0.0
NCT04594707,,2020-10-15,2024-02-02,,2024-05-08,2020-10-15,2020-10-20,ACTUAL,2024-05-08,2024-05-16,ACTUAL,,,,2024-05-08,2024-05-16,ACTUAL,2021-08-30,ACTUAL,2021-08-30,2024-05,2024-05-31,2023-02-10,ACTUAL,2023-02-10,2023-02-10,ACTUAL,2023-02-10,,INTERVENTIONAL,STARSCAPE-OLE,,A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis,A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF),TERMINATED,,PHASE3,117.0,ACTUAL,Hoffmann-La Roche,This study was terminated early due to the Sponsor's decision to terminate the parent study early.,1.0,,The study was terminated by Sponsor as the futility analysis outcome indicated that the study was unlikely to meet the predefined primary objective of the study. No new safety concerns were identified.,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,INDUSTRY,,,,,,,2023,0.0
NCT02352948,,2015-01-28,2019-02-07,,2024-07-25,2015-01-28,2015-02-02,ESTIMATED,2019-03-25,2019-04-16,ACTUAL,,,,2024-07-25,2024-07-26,ACTUAL,2015-01-13,ACTUAL,2015-01-13,2024-07,2024-07-31,2023-08-30,ACTUAL,2023-08-30,2018-02-09,ACTUAL,2018-02-09,,INTERVENTIONAL,ARCTIC,Sub-study A and B: Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.,"A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer","A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC).",COMPLETED,,PHASE3,597.0,ACTUAL,AstraZeneca,,6.0,,,f,,,,t,,,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,INDUSTRY,,,,,,,2023,1.0
NCT03947255,,2019-05-09,2023-08-03,,2023-10-11,2019-05-09,2019-05-13,ACTUAL,2023-10-11,2023-10-13,ACTUAL,,,,2023-10-11,2023-10-13,ACTUAL,2019-10-28,ACTUAL,2019-10-28,2023-10,2023-10-31,2022-11-06,ACTUAL,2022-11-06,2022-11-06,ACTUAL,2022-11-06,,INTERVENTIONAL,,The full analysis set includes participants who received at least one dose of study treatment.,A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma,"A Phase 2, Multicenter, Single-arm Study of Retreatment With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classic Hodgkin Lymphoma (cHL) or CD30-expressing Peripheral T Cell Lymphoma (PTCL)",TERMINATED,,PHASE2,12.0,ACTUAL,Seagen Inc.,,1.0,,Study stopped early due to low patient accrual.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:22:51.538102,2024-10-16 09:22:51.538102,INDUSTRY,,,,,,,2022,0.0
NCT04843579,,2021-04-10,2023-08-30,,2023-10-04,2021-04-10,2021-04-13,ACTUAL,2023-10-04,2023-10-25,ACTUAL,,,,2023-10-04,2023-10-25,ACTUAL,2021-12-29,ACTUAL,2021-12-29,2023-10,2023-10-31,2022-12-30,ACTUAL,2022-12-30,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,ClaSPd,,"Treatment of Selinexor in Combination With Clarithromycin, Pomalidomide and Dexamethasone for Relapsed Refractory Multiple Myeloma Patients","A Phase 2, Open-Label, Single-Arm Study of Selinexor in Combination With Clarithromycin, Pomalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma",TERMINATED,,PHASE2,4.0,ACTUAL,Weill Medical College of Cornell University,"The statistical analysis plan (and associated statistical power) was based on an expected sample size of 26 participants. As only 4 participants enrolled, this reduced sample size was not sufficient for the statistical analysis plan as written, and, therefore, only descriptive statistics for the response proportions can be presented for the study.",1.0,,low enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,OTHER,,,,,,,2022,0.0
NCT03300544,,2017-10-02,2023-03-16,,2024-05-01,2017-10-02,2017-10-03,ACTUAL,2024-04-03,2024-05-01,ACTUAL,,,,2024-05-01,2024-05-23,ACTUAL,2019-05-14,ACTUAL,2019-05-14,2024-01,2024-01-31,2022-03-22,ACTUAL,2022-03-22,2022-03-22,ACTUAL,2022-03-22,,INTERVENTIONAL,,,"Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer",A Phase I Study of Talimogene Laherparepvec (Talimogene Laherparepvec) With Neoadjuvant Chemotherapy and Radiation in Adenocarcinoma of the Rectum,TERMINATED,,PHASE1,3.0,ACTUAL,National Cancer Institute (NCI),,1.0,,Inadequate accrual rate,f,,,,t,t,f,,,,,,,,,,,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,NIH,,,,,,,2022,0.0
NCT03698448,,2018-10-03,,,2022-06-27,2018-10-05,2018-10-09,ACTUAL,,,,,,,2022-06-27,2022-06-30,ACTUAL,2021-09-01,ESTIMATED,2021-09-01,2022-06,2022-06-30,2022-11-01,ESTIMATED,2022-11-01,2022-10-01,ESTIMATED,2022-10-01,,INTERVENTIONAL,SMR3372,,A Dose-finding Study of Inhaled OligoG vs Placebo in Patients With Cystic Fibrosis,"A Randomized, Double Blind, Dose-finding Study of Inhaled Oligosaccharide (OligoG) vs Placebo in Patients With Cystic Fibrosis",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,AlgiPharma AS,,4.0,,Determined not feasible,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,INDUSTRY,,,,,,,2022,0.0
NCT04511624,,2020-08-03,,,2022-09-16,2020-08-12,2020-08-13,ACTUAL,,,,,,,2022-09-16,2022-09-19,ACTUAL,2020-08-27,ACTUAL,2020-08-27,2022-09,2022-09-30,2022-07-22,ACTUAL,2022-07-22,2022-07-22,ACTUAL,2022-07-22,,INTERVENTIONAL,,,Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects,"A Phase I Randomized, Double-Blind, Placebo-Controlled, Single Subcutaneous or Intravenous Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IBI112 in Healthy Subjects",COMPLETED,,PHASE1,46.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,7.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,INDUSTRY,,,,,,,2022,1.0
NCT04425538,,2020-06-08,2021-08-23,,2022-04-15,2020-06-08,2020-06-11,ACTUAL,2021-12-01,2021-12-03,ACTUAL,,,,2022-04-15,2022-04-20,ACTUAL,2020-06-01,ACTUAL,2020-06-01,2022-04,2022-04-30,2021-01-22,ACTUAL,2021-01-22,2021-01-22,ACTUAL,2021-01-22,,INTERVENTIONAL,,,A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19).,A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19).,COMPLETED,,PHASE2,17.0,ACTUAL,Tufts Medical Center,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,OTHER,,,,,,,2021,1.0
NCT04763564,,2021-02-16,2024-06-04,,2024-06-28,2021-02-16,2021-02-21,ACTUAL,2024-06-28,2024-07-23,ACTUAL,,,,2024-06-28,2024-07-23,ACTUAL,2022-03-22,ACTUAL,2022-03-22,2023-10,2023-10-31,2023-10-16,ACTUAL,2023-10-16,2023-10-16,ACTUAL,2023-10-16,,INTERVENTIONAL,,,Efficacy of Liraglutide Therapy in Patients With IPAA,Efficacy of Liraglutide Therapy in Patients With an Ileal -Pouch Anal Anastomosis (IPAA) and Chronic High Bowel Frequency,TERMINATED,,PHASE2,8.0,ACTUAL,"University of North Carolina, Chapel Hill",Small cross-over proof of concept study. The findings need to be verified in a more extensive prospective randomized study.,2.0,,"Due to an interruption in drug supply, the study was terminated",f,,,,f,t,f,,,,,,Beginning 3 months and ending 36 months following article publication.,Researchers who provide a methodologically sound proposal.,,YES,"Deidentified individual data that supports the results will be shared beginning 3 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina \[UNC\].",2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,OTHER,,,,,,,2023,0.0
NCT04645966,,2020-11-20,2023-09-11,,2023-09-11,2020-11-20,2020-11-27,ACTUAL,2023-09-11,2024-03-25,ACTUAL,,,,2023-09-11,2024-03-25,ACTUAL,2020-11-26,ACTUAL,2020-11-26,2023-09,2023-09-30,2022-09-15,ACTUAL,2022-09-15,2022-09-15,ACTUAL,2022-09-15,,INTERVENTIONAL,,Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.,"A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants","A PHASE 2b TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY INFANTS 2 AND 6 MONTHS OF AGE",TERMINATED,,PHASE2,326.0,ACTUAL,Pfizer,Study was terminated based on Sponsor's careful review of available safety data in concert with the recommendation of an independent Data Monitoring Committee.,11.0,,The Sponsor decided to discontinue the study based on Sponsor's careful review of available safety data in concert with the recommendation of an independent Data Monitoring Committee.,f,,,,t,f,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 19:05:07.645059,2024-10-16 19:05:07.645059,INDUSTRY,,,,,,,2022,0.0
NCT02826512,,2016-07-05,,,2022-07-15,2016-07-07,2016-07-11,ESTIMATED,,,,,,,2022-07-15,2022-07-18,ACTUAL,2018-05-15,ACTUAL,2018-05-15,2022-07,2022-07-31,2022-07-01,ACTUAL,2022-07-01,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,,,"A Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients","A Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients: the ABC Study",TERMINATED,,PHASE2,9.0,ACTUAL,The Netherlands Cancer Institute,,1.0,,"Not enough eligble patient can be found, too many screen failures",f,,,,t,f,f,,,,,,,,,UNDECIDED,to be determined,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,OTHER,,,,,,,2022,0.0
NCT02562443,,2015-09-25,,,2022-09-22,2015-09-25,2015-09-29,ESTIMATED,,,,,,,2022-09-22,2022-09-26,ACTUAL,2015-12-02,ACTUAL,2015-12-02,2022-09,2022-09-30,2021-07-26,ACTUAL,2021-07-26,2020-07-26,ACTUAL,2020-07-26,,INTERVENTIONAL,INSPIRE,,Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA,"A Phase III, International, Randomized, Controlled Study of Rigosertib Versus Physician's Choice of Treatment in Patients With Myelodysplastic Syndrome After Failure of a Hypomethylating Agent",TERMINATED,,PHASE3,372.0,ACTUAL,"Traws Pharma, Inc.",,2.0,,Top line analysis indicated that the study had failed to achieve its primary endpoint.,f,,,,t,,,,,,,,,,,,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,INDUSTRY,,,,,,,2021,0.0
NCT03256331,,2017-08-13,,,2020-05-29,2017-08-17,2017-08-22,ACTUAL,,,,,,,2020-05-29,2020-06-01,ACTUAL,2017-06-21,ACTUAL,2017-06-21,2020-05,2020-05-31,2020-03-30,ACTUAL,2020-03-30,2020-03-30,ACTUAL,2020-03-30,,INTERVENTIONAL,,,Evaluate the Safety of BEL-X-HG in Advanced Cancer Patients,"A Phase I, Open-Label, Dose Escalation and Extension Study to Evaluate the Safety, Tolerability and Preliminary Effects of Oral BEL-X-HG in Patients With Advanced Refractory Solid Malignancies",TERMINATED,,PHASE1,23.0,ACTUAL,Belx Bio-Pharmaceutical (Taiwan) Corporation,,1.0,,In the light of the on-going COVID-19 pandemic and the resulted difficulty in patient recruitment.,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,INDUSTRY,,,,,,,2020,0.0
NCT04265755,,2020-02-10,2023-12-14,,2023-12-14,2020-02-10,2020-02-12,ACTUAL,2023-12-14,2024-06-07,ACTUAL,,,,2023-12-14,2024-06-07,ACTUAL,2020-10-26,ACTUAL,2020-10-26,2023-12,2023-12-31,2023-01-18,ACTUAL,2023-01-18,2023-01-18,ACTUAL,2023-01-18,,INTERVENTIONAL,INTERROGATE,Full Analysis Set (FAS): consisted of all participants who were enrolled in the study.,Biomarker and Genetic Predictors of Erenumab Treatment Response,"Biomarker and Genetic Predictors of Erenumab Treatment Response, a Phase 4 Investigational Open-label Study (INTERROGATE)",COMPLETED,,PHASE4,1406.0,ACTUAL,Amgen,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,There is not a plan to make IPD available,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,INDUSTRY,,,,,,,2023,1.0
NCT01968213,,2013-10-17,2018-05-08,,2023-06-07,2013-10-18,2013-10-23,ESTIMATED,2018-08-01,2018-08-03,ACTUAL,,,,2023-06-07,2023-06-09,ACTUAL,2014-04-07,ACTUAL,2014-04-07,2023-06,2023-06-30,2022-07-07,ACTUAL,2022-07-07,2017-04-01,ACTUAL,2017-04-01,,INTERVENTIONAL,ARIEL3,,Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3),"A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer ( ARIEL3 )",COMPLETED,,PHASE3,564.0,ACTUAL,pharmaand GmbH,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,INDUSTRY,,,,,,,2022,1.0
NCT05105412,,2021-10-07,,,2024-07-03,2021-11-01,2021-11-03,ACTUAL,,,,,,,2024-07-03,2024-07-08,ACTUAL,2022-06-15,ACTUAL,2022-06-15,2024-06,2024-06-30,2024-03-30,ACTUAL,2024-03-30,2024-03-30,ACTUAL,2024-03-30,,INTERVENTIONAL,,,Lenalidomide and Gemcitabine in Relapsed or Refractory Peripheral T-cell Lymphomas,A Single Arm，Phase Ib/II Study of the Combination of Lenalidomide and Gemcitabine in Relapsed or Refractory Peripheral T-cell Lymphomas (PTCL),TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,"National Health Research Institutes, Taiwan",,1.0,,The resolution of DSMB,f,,,,t,f,f,,,,,,,,,,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,OTHER,,,,,,,2024,0.0
NCT04370834,,2020-04-30,2021-05-28,,2021-07-16,2020-04-30,2020-05-01,ACTUAL,2021-05-28,2021-06-04,ACTUAL,,,,2021-07-16,2021-07-20,ACTUAL,2020-05-28,ACTUAL,2020-05-28,2021-07,2021-07-31,2021-01-14,ACTUAL,2021-01-14,2021-01-14,ACTUAL,2021-01-14,,INTERVENTIONAL,,,Tocilizumab for Patients With Cancer and COVID-19 Disease,Tocilizumab in Hospitalized Cancer Patients With Coronavirus 2019 (SARS-CoV-2) and Severe Complications of Coronavirus Disease 19 (COVID-19),TERMINATED,,PHASE2,1.0,ACTUAL,National Cancer Institute (NCI),Early termination as randomized data did not support continuation.,1.0,,Other - Randomized data no longer support continuation,,,,,t,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.",2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,NIH,,,,,,,2021,0.0
NCT03926195,,2019-04-19,2023-05-26,2021-07-27,2024-04-05,2019-04-19,2019-04-24,ACTUAL,2023-07-13,2023-08-01,ACTUAL,,2023-08-01,ACTUAL,2024-04-05,2024-04-30,ACTUAL,2019-05-28,ACTUAL,2019-05-28,2024-04,2024-04-30,2023-05-10,ACTUAL,2023-05-10,2020-08-14,ACTUAL,2020-08-14,,INTERVENTIONAL,MANTA-RAy,The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug.,"Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis","A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis",COMPLETED,,PHASE2,109.0,ACTUAL,Galapagos NV,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,INDUSTRY,,,,,,,2023,0.0
NCT04513067,,2020-08-11,,,2023-12-03,2020-08-11,2020-08-14,ACTUAL,,,,,,,2023-12-03,2023-12-08,ACTUAL,2020-08-21,ACTUAL,2020-08-21,2023-12,2023-12-31,2023-07-26,ACTUAL,2023-07-26,2023-07-26,ACTUAL,2023-07-26,,INTERVENTIONAL,,,A Safety Study of YQ23 in Advanced Solid Tumors Patients,"A Phase Ib, Open-label, Dose-escalation Study of YQ23 as a Single Agent and in Combination With Pembrolizumab Administered to Patients With Advanced Solid Tumors",TERMINATED,,PHASE1,3.0,ACTUAL,New Beta Innovation Limited,,2.0,,Due to business decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,INDUSTRY,,,,,,,2023,0.0
NCT03741712,,2018-10-17,,,2021-02-02,2018-11-12,2018-11-15,ACTUAL,,,,,,,2021-02-02,2021-02-05,ACTUAL,2018-11-20,ACTUAL,2018-11-20,2018-07,2018-07-31,2020-12-08,ACTUAL,2020-12-08,2019-09-30,ACTUAL,2019-09-30,,INTERVENTIONAL,,,A Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of mCRPC,"A Phase I/II,Open-Label,Does-Escalation and -Expansion, Safety,Pharmacokinetics and Efficacy Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of Patients With Metastatic Castration Resistant Prostate Cancer",TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,2.0,,According to the available data from the trial，the sponsor determined to terminate this study.,f,,,,t,f,f,,,,,,,,,,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,INDUSTRY,,,,,,,2020,0.0
NCT04933968,,2021-06-07,2024-04-17,,2024-06-04,2021-06-14,2021-06-22,ACTUAL,2024-06-04,2024-06-06,ACTUAL,,,,2024-06-04,2024-06-06,ACTUAL,2022-03-21,ACTUAL,2022-03-21,2024-06,2024-06-30,2024-01-31,ACTUAL,2024-01-31,2024-01-31,ACTUAL,2024-01-31,,INTERVENTIONAL,,"The modified intent-to-treat population for Part A which included all randomized participants who received any amount of ALVR106 or placebo and had confirmed virologic infection of interest at baseline (detectable viral load). One participant randomized to the placebo cohort did not receive study treatment and is not included. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the baseline analysis population.",Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant,"Phase 1/2, Double-Blind, Placebo-Controlled, Dose Escalation and Expansion Study of ALVR106 in Addition to Standard of Care for the Treatment of High-Risk Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant",TERMINATED,,PHASE1/PHASE2,17.0,ACTUAL,AlloVir,Results are included for Part A only as no participants were enrolled into Part B due to early study termination.,2.0,,Strategic sponsor decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,INDUSTRY,,,,,,,2024,0.0
NCT03151811,,2017-05-09,2022-04-27,,2024-01-29,2017-05-11,2017-05-12,ACTUAL,2022-07-01,2022-07-27,ACTUAL,,,,2024-01-29,2024-01-30,ACTUAL,2017-06-12,ACTUAL,2017-06-12,2023-12,2023-12-31,2023-02-03,ACTUAL,2023-02-03,2021-02-03,ACTUAL,2021-02-03,,INTERVENTIONAL,OCEAN,All patients that were enrolled defined as patients assigned a unique patient number by Interactive Response Technology system at the time of enrollment.,A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide,"A Randomized, Controlled, Open-label, Phase 3 Study of Melflufen/Dexamethasone Compared With Pomalidomide/Dexamethasone for Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Lenalidomide",TERMINATED,,PHASE3,495.0,ACTUAL,Oncopeptides AB,,2.0,,Sponsor assessed all endpoints and collected Overall Survival data for another two years following the primary completion date of 03Feb2021.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,INDUSTRY,,,,,,,2023,0.0
NCT04964557,,2021-06-15,2023-07-12,,2023-11-20,2021-07-06,2021-07-16,ACTUAL,2023-11-20,2023-12-15,ACTUAL,,,,2023-11-20,2023-12-15,ACTUAL,2021-07-07,ACTUAL,2021-07-07,2023-11,2023-11-30,2022-07-15,ACTUAL,2022-07-15,2022-07-15,ACTUAL,2022-07-15,,INTERVENTIONAL,SOLANO,"Baseline analysis population is based on the Full analysis set (FAS) which includes all subjects who were randomly assigned to study intervention. Subjects were analysed according to their randomised study medication assignment, irrespective of the treatment actually received. Number Started in the Participant Flow is the number of subjects who were randomised.","A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia","A Randomised, Parallel, Double-Blind, Placebo-Controlled Phase 2b Study to Assess the Safety, Tolerability and Efficacy of AZD8233 Treatment in Participants With Hyperlipidaemia",COMPLETED,,PHASE2,411.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,INDUSTRY,,,,,,,2022,1.0
NCT03285607,,2017-09-14,,,2018-08-14,2017-09-14,2017-09-18,ACTUAL,,,,,,,2018-08-14,2018-08-16,ACTUAL,2018-09-30,ESTIMATED,2018-09-30,2018-08,2018-08-31,2021-02-28,ESTIMATED,2021-02-28,2019-10-31,ESTIMATED,2019-10-31,,INTERVENTIONAL,,,"MCS110 Combined With Neoadjuvant Doxorubicin, Cyclophosphamide, and Weekly Paclitaxel in Patients With Hormone-Receptor Positive and HER2- Breast Cancer","Phase I Study of MCS110 Combined With Neoadjuvant Dose-Dense Doxorubicin, Cyclophosphamide, and Weekly Paclitaxel in Patients With Hormone-Receptor Positive and HER2- Breast Cancer",WITHDRAWN,,PHASE1,0.0,ACTUAL,Washington University School of Medicine,,3.0,,Drug provider decided not to move forward with the study.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,OTHER,,,,,,,2021,0.0
NCT04423757,,2020-06-08,2023-04-18,,2023-05-17,2020-06-08,2020-06-09,ACTUAL,2023-04-18,2023-05-11,ACTUAL,,,,2023-05-17,2023-06-13,ACTUAL,2020-06-22,ACTUAL,2020-06-22,2023-05,2023-05-31,2022-05-08,ACTUAL,2022-05-08,2022-04-19,ACTUAL,2022-04-19,,INTERVENTIONAL,,Treated Set (TS): all subjects who were randomized and received at least one administration of study drug.,A Home-based Study Using Mobile Technology to Test Whether BI 1358894 is Effective in People With Depression,"A Phase II 6-week, Randomized, Double-blinded, Placebo Controlled, Parallel Group Decentralised Clinical Trial to Evaluate Efficacy and Safety of Oral BI 1358894 in Patients With Major Depressive Disorder With Inadequate Response to Antidepressants",TERMINATED,,PHASE2,45.0,ACTUAL,Boehringer Ingelheim,Results should be interpreted in a descriptive manner since the trial was terminated early and the specified number of patients required for the analyses was not obtained.,2.0,,Recruitment challenges,f,,,,f,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,INDUSTRY,,,,,,,2022,0.0
NCT04791514,,2021-03-08,2023-08-25,,2023-08-25,2021-03-08,2021-03-10,ACTUAL,2023-08-25,2023-09-22,ACTUAL,,,,2023-08-25,2023-09-22,ACTUAL,2022-03-29,ACTUAL,2022-03-29,2023-08,2023-08-31,2022-08-26,ACTUAL,2022-08-26,2022-08-26,ACTUAL,2022-08-26,,INTERVENTIONAL,,"The study was terminated by the Sponsor due to low enrolment. As only 1 participant was enrolled in this study, no data is reported here, in order to protect and maintain participant privacy/confidentiality.",A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH),"An Open-Label Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension",TERMINATED,,PHASE2,1.0,ACTUAL,Insmed Incorporated,"The study was terminated by the Sponsor due to low enrolment. As only 1 participant was enrolled in this study, no data is reported here, in order to protect and maintain participant privacy/confidentiality.",1.0,,Low enrolment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,INDUSTRY,,,,,,,2022,0.0
NCT04990778,,2021-07-26,,,2022-02-23,2021-07-27,2021-08-04,ACTUAL,,,,,,,2022-02-23,2022-03-10,ACTUAL,2021-11-30,ESTIMATED,2021-11-30,2022-02,2022-02-28,2023-03-24,ESTIMATED,2023-03-24,2023-03-24,ESTIMATED,2023-03-24,,INTERVENTIONAL,,,Venetoclax and Eprenetapopt for the Treatment of Relapsed of Refractory Mantle Cell Lymphoma,"An Open Label, Phase II Investigator-Initiated Study of Venetoclax and Eprenetapopt (APR-246) in Previously Treated Relapsed/Refractory Patients With Mantle Cell Lymphoma (MCL)",WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,PI Request,f,,,,t,t,f,,,,,,,,,,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,OTHER,,,,,,,2023,0.0
NCT02435095,,2015-04-14,,,2020-11-23,2015-04-30,2015-05-06,ESTIMATED,,,,,,,2020-11-23,2020-11-25,ACTUAL,2015-05,,2015-05-31,2020-11,2020-11-30,2020-08,ACTUAL,2020-08-31,2020-08,ACTUAL,2020-08-31,,INTERVENTIONAL,APIC,,Antipsychotic Induced Structural and Functional Brain Changes,Are Antipsychotics Neurotoxic or Neuroprotective? A Long-term Comparison of Two Treatment Strategies,TERMINATED,,PHASE4,174.0,ACTUAL,RWTH Aachen University,,2.0,,"slow patient recruitment, low patient-commpliance, high dropout rates,",f,,,,t,,,,,,,,,,,,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,OTHER,,,,,,,2020,0.0
NCT03445533,,2018-02-13,2022-08-19,,2022-10-17,2018-02-20,2018-02-26,ACTUAL,2022-10-17,2022-11-08,ACTUAL,,,,2022-10-17,2022-11-08,ACTUAL,2018-05-30,ACTUAL,2018-05-30,2022-10,2022-10-31,2021-06-01,ACTUAL,2021-06-01,2021-06-01,ACTUAL,2021-06-01,,INTERVENTIONAL,,,A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma,A Randomized Phase 3 Comparison of IMO-2125 With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301),TERMINATED,,PHASE3,481.0,ACTUAL,"Idera Pharmaceuticals, Inc.",,2.0,,Lack of Efficacy,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,INDUSTRY,,,,,,,2021,0.0
NCT03449030,,2018-02-22,2021-02-24,,2021-02-24,2018-02-22,2018-02-28,ACTUAL,2021-02-24,2021-03-22,ACTUAL,,,,2021-02-24,2021-03-22,ACTUAL,2018-04-23,ACTUAL,2018-04-23,2021-02,2021-02-28,2020-02-27,ACTUAL,2020-02-27,2020-02-27,ACTUAL,2020-02-27,,INTERVENTIONAL,,The safety population was defined as all participants who received at least 1 dose of study drug.,A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC),"An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-164, an Antibody-Drug Conjugate, in Patients With Advanced Gastrointestinal Cancers Expressing Guanylyl Cyclase C",TERMINATED,,PHASE1,31.0,ACTUAL,Takeda,,3.0,,Insufficient clinical benefit to participants at the selected recommended phase 2 (RP2D) dose in Part A.,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,INDUSTRY,,,,,,,2020,0.0
NCT04102007,,2019-09-23,2023-01-11,,2023-11-03,2019-09-23,2019-09-25,ACTUAL,2023-03-17,2023-03-21,ACTUAL,,,,2023-11-03,2023-11-27,ACTUAL,2019-11-12,ACTUAL,2019-11-12,2023-11,2023-11-30,2022-11-07,ACTUAL,2022-11-07,2022-01-17,ACTUAL,2022-01-17,,INTERVENTIONAL,,,A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab,"A Phase 3b, Multicenter, Interventional, Open-label Study of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Have a Suboptimal Response to Secukinumab or Ixekizumab and Are Switched to Risankizumab",COMPLETED,,PHASE3,244.0,ACTUAL,AbbVie,,1.0,,,f,,,,f,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvieclinicaltrials.com/hcp/data-sharing/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,INDUSTRY,,,,,,,2022,1.0
NCT03875859,,2019-03-13,2021-04-28,,2021-04-28,2019-03-13,2019-03-15,ACTUAL,2021-04-28,2021-05-20,ACTUAL,,,,2021-04-28,2021-05-20,ACTUAL,2019-12-12,ACTUAL,2019-12-12,2021-04,2021-04-30,2021-01-30,ACTUAL,2021-01-30,2020-05-14,ACTUAL,2020-05-14,,INTERVENTIONAL,,,Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC),"A Phase 2 Open Label, Single Arm Trial to Investigate the Efficacy and Safety of Topical Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of Squamous Cell Carcinoma (SCC)",TERMINATED,,PHASE2,4.0,ACTUAL,Stanford University,,1.0,,The available study medication reached expiry (logistics).,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,OTHER,,,,,,,2021,0.0
NCT03596970,,2015-06-25,,,2018-07-13,2018-07-13,2018-07-24,ACTUAL,,,,,,,2018-07-13,2018-07-24,ACTUAL,2015-09,,2015-09-30,2018-07,2018-07-31,2020-12,ESTIMATED,2020-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,Prometheus,,Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.,"A 24-month Multi-center, Open-label, Randomized, Controlled Study to Evaluate the Evolution of Renal Function in Maintenance Liver Transplant Recipients Receiving Either RAD001 (Everolimus) Plus Reduced TAC or RAD001 (Everolimus) Plus Mycophenolate Mofetil (MMF)",WITHDRAWN,,PHASE3,0.0,ACTUAL,Novartis,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,INDUSTRY,,,,,,,2020,0.0
NCT00567567,,2007-12-04,2017-01-20,,2022-04-01,2007-12-04,2007-12-05,ESTIMATED,2017-05-22,2017-06-27,ACTUAL,,,,2022-04-01,2022-04-28,ACTUAL,2007-11-05,ACTUAL,2007-11-05,2021-12,2021-12-31,2022-03-31,ACTUAL,2022-03-31,2015-02-27,ACTUAL,2015-02-27,,INTERVENTIONAL,,,Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma,Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma,COMPLETED,,PHASE3,665.0,ACTUAL,Children's Oncology Group,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 23:35:43.850437,2024-10-15 23:35:43.850437,NETWORK,,,,,,,2022,1.0
NCT00442130,,2007-02-27,,,2020-09-15,2007-02-27,2007-03-01,ESTIMATED,,,,,,,2020-09-15,2020-09-17,ACTUAL,2007-02,,2007-02-28,2020-09,2020-09-30,2020-04,ACTUAL,2020-04-30,2014-02,ACTUAL,2014-02-28,,INTERVENTIONAL,,,Reduced Intensity Stem Cell Transplantation for Chronic Lymphocytic Leukemia Followed by Vaccination,Reduced Intensity Stem Cell Transplantation for Advanced Chronic Lymphocytic Leukemia Followed by Vaccination With Lethally Irradiated Autologous Tumor Cells Admixed With Granulocyte Macrophage-colony Stimulating Factor Secreting K562 Cells,COMPLETED,,PHASE1,27.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,OTHER,,,,,,,2020,1.0
NCT04066595,,2019-08-21,,,2021-08-24,2019-08-22,2019-08-26,ACTUAL,,,,,,,2021-08-24,2021-08-30,ACTUAL,2020-02-10,ACTUAL,2020-02-10,2021-08,2021-08-31,2021-07-01,ACTUAL,2021-07-01,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,CabUC,,Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma.,Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma Who Have Progressed After Cisplatin-based Chemotherapy and Anti-PD-1/PD-L1 Therapy or After Anti-PD-1/PD-L1 Therapy Only.,TERMINATED,,PHASE2,7.0,ACTUAL,Johannes Gutenberg University Mainz,,1.0,,Recruitment problems,f,,,,t,f,f,,,,,,,,,,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,OTHER,,,,,,,2021,0.0
NCT02233829,,2014-09-06,,,2024-04-23,2014-09-06,2014-09-09,ESTIMATED,,,,,,,2024-04-23,2024-04-24,ACTUAL,2024-04-23,ACTUAL,2024-04-23,2024-04,2024-04-30,2024-04-23,ACTUAL,2024-04-23,2024-04-23,ACTUAL,2024-04-23,,INTERVENTIONAL,,,Dopamine Rhythms in Health and Addiction,Dopamine Rhythms in Health and Addiction,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,"No enrollment, delay with drug availability.",f,,,,,t,f,,,,,,,,,NO,.Data is analyzed by subject group and not on an individual basis.,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,NIH,,,,,,,2024,0.0
NCT03806985,,2019-01-14,,,2023-10-11,2019-01-14,2019-01-16,ACTUAL,,,,,,,2023-10-11,2023-10-12,ACTUAL,2019-03-28,ACTUAL,2019-03-28,2023-10,2023-10-31,2023-06-27,ACTUAL,2023-06-27,2023-06-27,ACTUAL,2023-06-27,,INTERVENTIONAL,,,Effects of Psilocybin in Concussion Headache,Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study II,TERMINATED,,PHASE1,12.0,ACTUAL,Yale University,,6.0,,Challenging to recruit qualifying subjects,f,,,,f,t,f,,,,,,,,,,,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,OTHER,,,,,,,2023,0.0
NCT02393248,,2015-01-30,2022-10-21,,2022-12-12,2015-03-18,2015-03-19,ESTIMATED,2022-12-12,2023-01-06,ACTUAL,,,,2022-12-12,2023-01-06,ACTUAL,2015-02-27,ACTUAL,2015-02-27,2022-12,2022-12-31,2021-12-17,ACTUAL,2021-12-17,2021-12-17,ACTUAL,2021-12-17,,INTERVENTIONAL,,,"Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)","A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)",TERMINATED,,PHASE1/PHASE2,201.0,ACTUAL,Incyte Corporation,,25.0,,,t,,,,f,t,,,,,,,,,,,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,INDUSTRY,,NCT03906357,NO_LONGER_AVAILABLE,,,,2021,0.0
NCT03149549,,2017-05-04,2021-10-01,,2024-01-03,2017-05-09,2017-05-11,ACTUAL,2024-01-03,2024-01-05,ACTUAL,,,,2024-01-03,2024-01-05,ACTUAL,2017-06-01,ACTUAL,2017-06-01,2024-01,2024-01-31,2020-09-10,ACTUAL,2020-09-10,2020-09-10,ACTUAL,2020-09-10,,INTERVENTIONAL,,"Summaries are presented by dose and schedule. Specifically, all available data from Parts A, A2, and B is pooled by dose group; Part C1 dosing 4 mg/kg Q2W and 6 mg/kg Q2W are also presented by dose and schedule.",PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors,"A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)",TERMINATED,,PHASE1/PHASE2,99.0,ACTUAL,CytomX Therapeutics,"This study was terminated early due to the Covid Pandemic and the company's business decision to separate the Phase 2 (part B) course of the study to a separate, new Phase 2 study. The Phase 1 (part A) course of the study was completed and the RP2D was determined. Part B only enrolled 3 patients and the Secondary and other Outcomes were not analyzed.",4.0,,Covid Pandemic; Business Decision to separate Phase 2 to new study,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:41:43.345167,2024-10-15 23:41:43.345167,INDUSTRY,,,,,,,2020,0.0
NCT03329092,,2017-10-06,2024-02-21,,2024-04-16,2017-10-27,2017-11-01,ACTUAL,2024-04-16,2024-05-07,ACTUAL,,,,2024-04-16,2024-05-07,ACTUAL,2018-04-05,ACTUAL,2018-04-05,2024-04,2024-04-30,2023-02-23,ACTUAL,2023-02-23,2023-02-23,ACTUAL,2023-02-23,,INTERVENTIONAL,REVISIT,The Intent to Treat (ITT) analysis set included all randomized participants regardless of receipt of study drug. Participants were analyzed according to the treatment to which they were randomized.,"A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.","A PHASE 3 PROSPECTIVE, RANDOMIZED, MULTICENTER, OPEN-LABEL, CENTRAL ASSESSOR-BLINDED, PARALLEL GROUP, COMPARATIVE STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) ±METRONIDAZOLE (MTZ) VERSUS MEROPENEM±COLISTIN (MER±COL) FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO GRAM NEGATIVE BACTERIA, INCLUDING METALLO-Β-LACTAMASE (MBL) - PRODUCING MULTIDRUG RESISTANT PATHOGENS, FOR WHICH THERE ARE LIMITED OR NO TREATMENT OPTIONS",COMPLETED,,PHASE3,422.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,INDUSTRY,,,,,,,2023,1.0
NCT03323437,,2017-10-02,2024-03-04,,2024-05-03,2017-10-25,2017-10-27,ACTUAL,2024-05-03,2024-05-06,ACTUAL,,,,2024-05-03,2024-05-06,ACTUAL,2017-09-15,ACTUAL,2017-09-15,2024-05,2024-05-31,2023-05-31,ACTUAL,2023-05-31,2023-05-31,ACTUAL,2023-05-31,,INTERVENTIONAL,,There are only 9 control subjects in the overall number of baseline participants as 4 of the 13 control subjects who were eligible decided to withdraw before completing the baseline procedures.,Biomarkers of Conversion Risk and Treatment Response in Early-Stage Schizophrenia,Biomarkers of Conversion Risk and Treatment Response in Early-Stage Schizophrenia,COMPLETED,,PHASE4,26.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,OTHER,,,,,,,2023,1.0
NCT02704403,,2016-02-16,2022-01-07,,2022-02-25,2016-03-04,2016-03-10,ESTIMATED,2022-02-25,2022-03-23,ACTUAL,,,,2022-02-25,2022-03-23,ACTUAL,2016-03,,2016-03-31,2022-02,2022-02-28,2020-10-28,ACTUAL,2020-10-28,2020-10-28,ACTUAL,2020-10-28,,INTERVENTIONAL,RESOLVE-IT,,Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH),"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis",TERMINATED,,PHASE3,2157.0,ACTUAL,Genfit,"The study was prematurely terminated based upon limited efficacy at time of the interim analysis, not due to safety concerns, and the conclusion that there would be limited benefit for participants to continue in the trial. Therefore, the results for efficacy endpoints other than the primary and key secondary endpoints are not presented in the disclosure of these results.",2.0,,"Study did not meet the predefined primary surrogate efficacy endpoint, no safety issues identified",f,,,,t,t,,,,,,,,,,UNDECIDED,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,INDUSTRY,,,,,,,2020,0.0
NCT02627677,,2015-08-13,2021-10-28,,2021-10-28,2015-12-09,2015-12-11,ESTIMATED,2021-10-28,2021-11-26,ACTUAL,,,,2021-10-28,2021-11-26,ACTUAL,2015-12-31,ACTUAL,2015-12-31,2021-10,2021-10-31,2021-01-20,ACTUAL,2021-01-20,2020-10-29,ACTUAL,2020-10-29,,INTERVENTIONAL,OPTIC-2L,Safety Population included all participants who have received at least 1 dose of study drug.,A Study Comparing Ponatinib and Nilotinib in Participants With Chronic Myeloid Leukemia,"A Randomized, Open-label Study of Ponatinib Versus Nilotinib in Patients With Chronic Myeloid Leukemia in Chronic Phase Following Resistance to Imatinib",TERMINATED,,PHASE3,44.0,ACTUAL,Takeda,This study was terminated due to operational feasibility and not due to any safety concerns.,3.0,,The study was stopped due to operational feasibility and not due to any safety concerns,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,INDUSTRY,,,,,,,2021,0.0
NCT04709835,,2021-01-12,2022-09-15,,2022-10-24,2021-01-13,2021-01-14,ACTUAL,2022-09-15,2022-10-13,ACTUAL,,,,2022-10-24,2022-10-26,ACTUAL,2021-02-03,ACTUAL,2021-02-03,2022-10,2022-10-31,2021-10-13,ACTUAL,2021-10-13,2021-09-17,ACTUAL,2021-09-17,,INTERVENTIONAL,,"The modified ITT infected (mITTi) population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.",Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19,"A Phase II Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Antiviral Activity, Safety, Pharmacokinetics, and Efficacy of RO7496998 (AT-527) in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19",COMPLETED,,PHASE2,104.0,ACTUAL,Hoffmann-La Roche,,3.0,,,f,,,,,t,f,,,t,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)",2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,INDUSTRY,,,,,,,2021,1.0
NCT04200066,,2019-12-05,,,2022-08-17,2019-12-12,2019-12-16,ACTUAL,,,,,,,2022-08-17,2022-08-22,ACTUAL,2022-06-01,ESTIMATED,2022-06-01,2022-08,2022-08-31,2024-02-01,ESTIMATED,2024-02-01,2023-10-01,ESTIMATED,2023-10-01,,INTERVENTIONAL,,,A Study of Maprotiline in Combination With Tamoxifen and Temozolomide for Recurrent Glioblastoma,A Phase 1 Study of Maprotiline in Combination With Tamoxifen and Temozolomide for Recurrent Glioblastoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Rochester,,1.0,,One of the drugs for the study is not commercially available.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,OTHER,,,,,,,2024,0.0
NCT04017130,,2019-07-10,,,2024-01-12,2019-07-10,2019-07-12,ACTUAL,,,,,,,2024-01-12,2024-01-17,ACTUAL,2020-02-05,ACTUAL,2020-02-05,2024-01,2024-01-31,2023-12-13,ACTUAL,2023-12-13,2023-12-13,ACTUAL,2023-12-13,,INTERVENTIONAL,,,A Study of MT-0169 in Participants With Relapsed or Refractory Multiple Myeloma,"A Phase 1, Open-Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MT-0169 in Patients With Relapsed or Refractory Multiple Myeloma",TERMINATED,,PHASE1,14.0,ACTUAL,"Molecular Templates, Inc.",,1.0,,Sparse/no patient enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,INDUSTRY,,,,,,,2023,0.0
NCT02896855,,2016-09-07,2019-06-18,,2021-11-15,2016-09-07,2016-09-12,ESTIMATED,2019-06-18,2019-07-10,ACTUAL,,,,2021-11-15,2021-12-16,ACTUAL,2016-09-13,ACTUAL,2016-09-13,2021-11,2021-11-30,2021-01-22,ACTUAL,2021-01-22,2018-06-27,ACTUAL,2018-06-27,,INTERVENTIONAL,PUFFIN,"Intent-to-Treat (ITT) population: consists of all randomized participants, regardless of whether they received any study treatment. Participants are grouped according to the treatment group to which they were randomized.",A Study to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel Versus Placebo + Trastuzumab + Docetaxel in Previously Untreated Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer,"A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab+Herceptin+Docetaxel Versus Placebo+Herceptin+Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer",COMPLETED,,PHASE3,243.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,t,f,,,t,,,,,,,,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,INDUSTRY,,,,,,,2021,1.0
NCT01730950,,2012-11-15,2020-02-20,,2022-12-27,2012-11-15,2012-11-21,ESTIMATED,2020-03-13,2020-03-17,ACTUAL,,,,2022-12-27,2022-12-29,ACTUAL,2012-12-20,ACTUAL,2012-12-20,2022-12,2022-12-31,2022-12-22,ACTUAL,2022-12-22,2018-09-03,ACTUAL,2018-09-03,,INTERVENTIONAL,,Eligible participants,Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma,Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma,COMPLETED,,PHASE2,182.0,ACTUAL,Radiation Therapy Oncology Group,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 23:41:43.345167,2024-10-15 23:41:43.345167,NETWORK,,,,,,,2022,1.0
NCT05111249,,2021-10-15,,,2024-02-04,2021-10-27,2021-11-08,ACTUAL,,,,,,,2024-02-04,2024-02-06,ACTUAL,2021-12-08,ACTUAL,2021-12-08,2024-02,2024-02-29,2023-10-27,ACTUAL,2023-10-27,2023-10-27,ACTUAL,2023-10-27,,INTERVENTIONAL,VIBRANT-HD,,A Dose Range Finding Study With Open-Label Extension to Evaluate the Safety of Oral LMI070/Branaplam in Early Manifest Huntington's Disease,"A Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study With Open-Label Extension to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of LMI070/Branaplam Administered as Weekly Oral Doses in Participants With Early Manifest Huntington's Disease",COMPLETED,,PHASE2,26.0,ACTUAL,Novartis,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,INDUSTRY,,,,,,,2023,0.0
NCT05204758,,2021-12-23,,,2022-01-09,2022-01-09,2022-01-24,ACTUAL,,,,,,,2022-01-09,2022-01-24,ACTUAL,2016-05-12,ACTUAL,2016-05-12,2022-01,2022-01-31,2021-02-28,ACTUAL,2021-02-28,2017-12-31,ACTUAL,2017-12-31,,INTERVENTIONAL,,,Prophylactic TCM for Mitigation of EGFR-TKI Related Dermatological Adverse Effect,Prophylactic TCM for Mitigation of EGFR-TKI Related Dermatological Adverse Effect,COMPLETED,,PHASE3,30.0,ACTUAL,China Medical University Hospital,,2.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,OTHER,,,,,,,2021,1.0
NCT04335786,,2020-04-02,,,2021-09-19,2020-04-02,2020-04-06,ACTUAL,,,,,,,2021-09-19,2021-09-24,ACTUAL,2020-04-17,ACTUAL,2020-04-17,2020-04,2020-04-30,2021-05-25,ACTUAL,2021-05-25,2021-05-25,ACTUAL,2021-05-25,,INTERVENTIONAL,,,Valsartan for Prevention of Acute Respiratory Distress Syndrome in Hospitalized Patients With SARS-COV-2 (COVID-19) Infection Disease,"PRAETORIAN-COVID: A Double-blind, Placebo-controlled Randomized Clinical Trial With Valsartan for PRevention of Acute rEspiraTORy dIstress Syndrome in hospitAlized patieNts With SARS-COV-2 (COVID-19) Infection Disease",TERMINATED,,PHASE4,23.0,ACTUAL,Radboud University Medical Center,,2.0,,Enrollment was stopped to facilitate successful enrollment for the ACE2RAS-domain of the REMAP-CAP trial.,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,OTHER,,,,,,,2021,0.0
NCT03655080,,2018-08-29,2021-09-15,,2021-10-15,2018-08-30,2018-08-31,ACTUAL,2021-10-15,2021-10-18,ACTUAL,,,,2021-10-15,2021-10-18,ACTUAL,2019-01-09,ACTUAL,2019-01-09,2021-10,2021-10-31,2021-06-15,ACTUAL,2021-06-15,2021-02-22,ACTUAL,2021-02-22,,INTERVENTIONAL,,,Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression,Novel Approach of Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression,TERMINATED,,PHASE2,2.0,ACTUAL,Washington University School of Medicine,,1.0,,Pharmaceutical company decided to close study,f,,,,t,t,t,,,t,,,,,,NO,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,OTHER,,,,,,,2021,0.0
NCT03486197,,2018-03-27,,,2024-05-03,2018-03-27,2018-04-03,ACTUAL,,,,,,,2024-05-03,2024-05-07,ACTUAL,2019-01-17,ACTUAL,2019-01-17,2024-05,2024-05-31,2024-05-01,ACTUAL,2024-05-01,2023-11-01,ACTUAL,2023-11-01,,INTERVENTIONAL,,,Neutron Radiation Therapy and Pembrolizumab in Treating Participants With Advanced Urothelial Carcinoma,Phase II Trial of Neutron Radiotherapy With Concurrent Checkpoint Inhibitor Immunotherapy (Pembrolizumab) in Patients With Advanced Urothelial Carcinoma,TERMINATED,,PHASE2,13.0,ACTUAL,University of Washington,,1.0,,Closed per SRC Low Accrual Policy,f,,,,,t,t,,,,,,,,,NO,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,OTHER,,,,,,,2024,0.0
NCT04063865,,2019-08-19,2021-08-17,,2023-04-28,2019-08-19,2019-08-21,ACTUAL,2023-04-28,2023-05-23,ACTUAL,,,,2023-04-28,2023-05-23,ACTUAL,2019-05-09,ACTUAL,2019-05-09,2023-04,2023-04-30,2020-07-02,ACTUAL,2020-07-02,2020-07-02,ACTUAL,2020-07-02,,INTERVENTIONAL,,,Everolimus Monotherapy as Immunosuppression After Liver Transplant,Protection of Renal Function After Liver Transplant Using Everolimus Monotherapy as the Immunosuppression Regimen,TERMINATED,,PHASE3,14.0,ACTUAL,Indiana University,,2.0,,Study was larger than expected and became a burden to faculty and staff resources.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,OTHER,,,,,,,2020,0.0
NCT04310865,,2020-03-15,,,2021-07-04,2020-03-15,2020-03-17,ACTUAL,,,,,,,2021-07-04,2021-07-07,ACTUAL,2021-11,ESTIMATED,2021-11-30,2021-07,2021-07-31,2023-04,ESTIMATED,2023-04-30,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Yinhu Qingwen Granula for the Treatment of Severe CoVID-19,"An Adaptive, Randomized, Double-blind, Parallel-controlled Clinical Trial of Yinhu Qingwen Granula for the Treatment of Severe CoVID-19",SUSPENDED,,PHASE2/PHASE3,116.0,ESTIMATED,China Academy of Chinese Medical Sciences,,2.0,,There were no eligible patients with CoVID-19 in the paticipated centers.,f,,,,t,f,f,,,,,,,,,,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,OTHER,,,,,,,2023,0.0
NCT03735316,,2018-11-07,2023-03-20,,2023-05-06,2018-11-07,2018-11-08,ACTUAL,2023-05-06,2023-05-10,ACTUAL,,,,2023-05-06,2023-05-10,ACTUAL,2019-04-25,ACTUAL,2019-04-25,2023-05,2023-05-31,2022-04-01,ACTUAL,2022-04-01,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,,,Vitamin B12a Vasoplegic Syndrome,"A Phase II, Randomized, Double-Blind, Placebo-Controlled Study for High-Dose Hydroxocobalamin (Vitamin B12A) for Vasopressor Refractory Hypotension Following Cardiopulmonary Bypass",TERMINATED,,PHASE2,8.0,ACTUAL,Mayo Clinic,Terminated study. Insufficient recruitment over study period,2.0,,Insufficient recruitment over study period,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,OTHER,,,,,,,2022,0.0
NCT02569476,,2015-09-18,2021-08-27,,2022-03-01,2015-10-04,2015-10-06,ESTIMATED,2021-10-05,2021-11-03,ACTUAL,,,,2022-03-01,2022-03-03,ACTUAL,2016-01-13,ACTUAL,2016-01-13,2022-03,2022-03-31,2020-09-02,ACTUAL,2020-09-02,2020-09-02,ACTUAL,2020-09-02,,INTERVENTIONAL,,,BGB 3111 in Combination With Obinutuzumab in Participants With B-Cell Lymphoid Malignancies,"A Phase 1b Study to Assess Safety, Tolerability and Antitumor Activity of the Combination of BGB 3111 With Obinutuzumab in Subjects With B-Cell Lymphoid Malignancies",COMPLETED,,PHASE1,119.0,ACTUAL,BeiGene,,1.0,,,f,,,,t,,,,,,,,,,,YES,,2024-10-15 23:41:43.345167,2024-10-15 23:41:43.345167,INDUSTRY,,,,,,,2020,1.0
NCT04778592,,2021-02-26,2023-05-09,,2023-11-06,2021-02-26,2021-03-03,ACTUAL,2023-05-09,2023-06-06,ACTUAL,,,,2023-11-06,2023-11-07,ACTUAL,2021-01-19,ACTUAL,2021-01-19,2023-11,2023-11-30,2022-05-25,ACTUAL,2022-05-25,2022-05-16,ACTUAL,2022-05-16,,INTERVENTIONAL,,The ITT population included all randomized subjects who received at least one dose of study treatment. One subject randomized to ETX-018810 withdrew consent to participate in the study before receiving their first dose of study medication.,Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain,"A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain",COMPLETED,,PHASE2,149.0,ACTUAL,Eliem Therapeutics (UK) Ltd.,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,INDUSTRY,,,,,,,2022,1.0
NCT04335071,,2020-04-02,,,2020-10-12,2020-04-02,2020-04-06,ACTUAL,,,,,,,2020-10-12,2020-10-14,ACTUAL,2020-04-26,ACTUAL,2020-04-26,2020-10,2020-10-31,2020-09-27,ACTUAL,2020-09-27,2020-09-27,ACTUAL,2020-09-27,,INTERVENTIONAL,CORON-ACT,,Tocilizumab in the Treatment of Coronavirus Induced Disease (COVID-19),"CORON-ACT - a Multicenter, Double-blind, Randomized Controlled Phase II Trial on the Efficacy and Safety of Tocilizumab in the Treatment of Coronavirus Induced Disease (COVID-19)",TERMINATED,,PHASE2,5.0,ACTUAL,"Insel Gruppe AG, University Hospital Bern",,2.0,,1.) Not possible to recruit the planned number of patients during the planned study period; 2.) Dexamethason was included in the standard of care for the study population during the course of the study and inclusion criteria could no longer be met.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,OTHER,,,,,,,2020,0.0
NCT04411134,,2020-05-30,,,2020-07-14,2020-05-30,2020-06-02,ACTUAL,,,,,,,2020-07-14,2020-07-15,ACTUAL,2020-05-28,ACTUAL,2020-05-28,2020-07,2020-07-31,2020-07-14,ACTUAL,2020-07-14,2020-07-14,ACTUAL,2020-07-14,,INTERVENTIONAL,,,E7 TCR T Cell Immunotherapy for High-Grade Cervical Intraepithelial Neoplasia,A Phase I Study of E7 TCR T Cell Immunotherapy for High-Grade Cervical Intraepithelial Neoplasia,WITHDRAWN,,PHASE1,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,Closed based on the lack of perceived clinical activity observed from a different study treating a similar patient population with same study agent.,f,,,,,t,f,,,,,,,,,,,2024-10-15 23:41:43.345167,2024-10-15 23:41:43.345167,NIH,,,,,,,2020,0.0
NCT02431325,,2015-02-23,2023-03-24,,2023-05-17,2015-04-29,2015-05-01,ESTIMATED,2023-05-17,2023-06-12,ACTUAL,,,,2023-05-17,2023-06-12,ACTUAL,2015-12,,2015-12-31,2023-05,2023-05-31,2021-01-21,ACTUAL,2021-01-21,2020-01-21,ACTUAL,2020-01-21,,INTERVENTIONAL,,,A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV,A Study to Investigate Gastrointestinal Epithelial Integrity and Arterial Inflammation in Individuals With and Without HIV,COMPLETED,,PHASE2,32.0,ACTUAL,Massachusetts General Hospital,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,OTHER,,,,,,,2021,1.0
NCT05783492,,2018-11-23,,,2023-03-23,2023-03-23,2023-03-24,ACTUAL,,,,,,,2023-03-23,2023-03-24,ACTUAL,2024-01-01,ESTIMATED,2024-01-01,2018-11,2018-11-30,2024-04-30,ESTIMATED,2024-04-30,2024-03-31,ESTIMATED,2024-03-31,,INTERVENTIONAL,,,INK Feasibility Study,Intranasal Ketamine for Procedural Sedation: a Feasibility Cohort Study,WITHDRAWN,,PHASE3,0.0,ACTUAL,Lawson Health Research Institute,,1.0,,Lack of availability of drug,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,OTHER,,,,,,,2024,0.0
NCT02707055,,2016-03-11,2022-02-23,2021-03-09,2022-02-23,2016-03-11,2016-03-14,ESTIMATED,2022-02-23,2022-03-16,ACTUAL,2021-03-09,2021-03-11,ACTUAL,2022-02-23,2022-03-16,ACTUAL,2016-06-15,ACTUAL,2016-06-15,2021-10,2021-10-31,2020-09-09,ACTUAL,2020-09-09,2020-02-20,ACTUAL,2020-02-20,,INTERVENTIONAL,,,A Novel Compound for Alcoholism Treatment: A Translational Strategy - Part II,A Novel Compound for Alcoholism Treatment: A Translational Strategy - Part II,TERMINATED,,PHASE2,42.0,ACTUAL,National Institutes of Health Clinical Center (CC),"Early termination of the study due to the COVID-19 pandemic resulted in a smaller number of participants analyzed, compared to the planned sample.",2.0,,Early termination of the study due to the COVID-19 pandemic,f,,,,t,t,f,,,,,,,,,,,2024-10-15 12:54:35.855551,2024-10-15 12:54:35.855551,NIH,,,,,,,2020,0.0
NCT04241315,,2020-01-22,2023-01-13,2022-02-09,2023-02-23,2020-01-22,2020-01-27,ACTUAL,2023-02-23,2023-03-23,ACTUAL,,2023-03-23,ACTUAL,2023-02-23,2023-03-23,ACTUAL,2020-03-26,ACTUAL,2020-03-26,2023-01,2023-01-31,2021-11-01,ACTUAL,2021-11-01,2021-10-07,ACTUAL,2021-10-07,,INTERVENTIONAL,Elucidate,,ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting,"A Phase 3, Randomized,Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules",COMPLETED,,PHASE3,112.0,ACTUAL,"On Target Laboratories, LLC",,2.0,,,f,,,,f,t,t,,,,,,,,,NO,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,INDUSTRY,,,,,,,2021,1.0
NCT05644600,,2022-12-01,,,2024-02-07,2022-12-01,2022-12-09,ACTUAL,,,,,,,2024-02-07,2024-02-08,ACTUAL,2023-05-26,ACTUAL,2023-05-26,2024-02,2024-02-29,2023-07-17,ACTUAL,2023-07-17,2023-07-17,ACTUAL,2023-07-17,,INTERVENTIONAL,,,A Study to Assess the Effect of AZD5055 on the Pharmacokinetics (PK) of Nintedanib in Healthy Participants.,"An Open Label, Randomised Study in Healthy Participants to Investigate the Effect of AZD5055 on the Pharmacokinetics of Nintedanib.",TERMINATED,,PHASE1,18.0,ACTUAL,AstraZeneca,,4.0,,The study was terminated as no drug-drug interactions were observed in Part-A of the study and therefore Part-B of the study was not required as per protocol.,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual subject-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual subject-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,INDUSTRY,,,,,,,2023,0.0
NCT04497948,,2020-06-16,2021-10-29,,2021-11-16,2020-07-31,2020-08-04,ACTUAL,2021-10-29,2021-11-05,ACTUAL,,,,2021-11-16,2021-11-17,ACTUAL,2020-09-21,ACTUAL,2020-09-21,2021-11,2021-11-30,2020-11-18,ACTUAL,2020-11-18,2020-11-18,ACTUAL,2020-11-18,,INTERVENTIONAL,,,Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19,"An Open-label, Multiple-dose Study of Acalabrutinib, Co Administered With a Proton-pump Inhibitor, in Participants Hospitalized With COVID-19",TERMINATED,,PHASE1,9.0,ACTUAL,Acerta Pharma BV,,1.0,,Data from the CALAVI Phase II trials for Acalabrutinib in patients hospitalized with COVID-19 did not meet their primary efficacy endpoints.~Based on this higher management made the decision to prematurely terminate the D822FC00005 PK study.,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,INDUSTRY,,,,,,,2020,0.0
NCT03223298,,2017-07-11,2022-12-17,,2023-01-19,2017-07-18,2017-07-21,ACTUAL,2023-01-19,2023-02-14,ACTUAL,,,,2023-01-19,2023-02-14,ACTUAL,2018-08-31,ACTUAL,2018-08-31,2023-01,2023-01-31,2020-03-13,ACTUAL,2020-03-13,2020-03-13,ACTUAL,2020-03-13,,INTERVENTIONAL,,,Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles,Comparison of Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles in the Management of Myofascial Pain Disorder: A Randomized Clinical Trial,COMPLETED,,PHASE3,75.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,OTHER,,,,,,,2020,1.0
NCT03579758,,2018-06-26,,,2020-06-03,2018-06-26,2018-07-09,ACTUAL,,,,,,,2020-06-03,2020-06-05,ACTUAL,2019-04-03,ACTUAL,2019-04-03,2020-06,2020-06-30,2020-06-01,ACTUAL,2020-06-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,,,Chemotherapy Before & After Surgery in Patients With Resectable Gallbladder Cancer,"Perioperative Chemotherapy Prior To and After Reoperation for Incidental Gallbladder Cancer - An International, Randomized Phase III Trial",WITHDRAWN,,PHASE3,0.0,ACTUAL,Emory University,,2.0,,This trial will open as an NCTN trial.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,OTHER,,,,,,,2020,0.0
NCT03052010,,2017-02-05,,,2021-10-17,2017-02-09,2017-02-14,ACTUAL,,,,,,,2021-10-17,2021-10-19,ACTUAL,2017-02-06,ACTUAL,2017-02-06,2021-10,2021-10-31,2021-04-30,ACTUAL,2021-04-30,2020-12-15,ACTUAL,2020-12-15,,INTERVENTIONAL,,,The Partners Scale-Up Project,Delivery of Integrated PrEP and ART for Couples in Kenya,COMPLETED,,PHASE4,4898.0,ACTUAL,University of Washington,,1.0,,,f,,,,t,f,f,,,,,,,,,YES,Data from the Partners Scale-Up Project will be available at end of the Project by contacting the International Clinical Research Center at the University of Washington (icrc@uw.edu),2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,OTHER,,,,,,,2021,1.0
NCT04199585,,2019-12-12,,,2020-05-11,2019-12-12,2019-12-16,ACTUAL,,,,,,,2020-05-11,2020-05-12,ACTUAL,2019-12-10,ACTUAL,2019-12-10,2020-05,2020-05-31,2020-02-19,ACTUAL,2020-02-19,2020-02-16,ACTUAL,2020-02-16,,INTERVENTIONAL,,,Safety and Tolerability of Lu AF95245 in Healthy Young Men,"Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending Oral Dose Study Investigating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Lu AF95245 and Open-label Crossover Study to Investigate Intra-subject Variability, Effect of Food on Lu AF95245, and Metabolic Profile of [14C]-Lu AF95245 in Healthy Young Men",TERMINATED,,PHASE1,18.0,ACTUAL,H. Lundbeck A/S,,2.0,,new safety data from another study,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-14 22:09:18.860311,2024-10-14 22:09:18.860311,INDUSTRY,,,,,,,2020,0.0
NCT05209152,,2022-01-13,,,2024-04-26,2022-01-13,2022-01-26,ACTUAL,,,,,,,2024-04-26,2024-04-30,ACTUAL,2022-11-14,ACTUAL,2022-11-14,2024-04,2024-04-30,2023-12-19,ACTUAL,2023-12-19,2023-12-19,ACTUAL,2023-12-19,,INTERVENTIONAL,,,AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic Leukemia,A Phase 1 Study of AMG 176 as Monotherapy and in Combination With Azacitidine in Higher-Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia,COMPLETED,,PHASE1,7.0,ACTUAL,Amgen,,3.0,,,f,,,,,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,INDUSTRY,,,,,,,2023,1.0
NCT03732469,,2018-10-31,,,2021-06-14,2018-11-05,2018-11-06,ACTUAL,,,,,,,2021-06-14,2021-06-18,ACTUAL,2019-11-01,ACTUAL,2019-11-01,2020-03,2020-03-31,2021-03-01,ACTUAL,2021-03-01,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Rectal Acetaminophen Use During Oocyte Retrievals to Reduce Post-Operative Opioid Utilization,Administration of Rectal Acetaminophen During Oocyte Retrievals Reduces Post-Operative Opioid Utilization in Fertility Patients,TERMINATED,,PHASE4,4.0,ACTUAL,University of South Florida,,2.0,,Significant change in our clinic structure prevented continued recruitment of patients to the study,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,OTHER,,,,,,,2021,0.0
NCT02608125,,2015-09-18,,,2020-12-23,2015-11-16,2015-11-18,ESTIMATED,,,,,,,2020-12-23,2020-12-24,ACTUAL,2015-10-28,ACTUAL,2015-10-28,2020-12,2020-12-31,2020-06-23,ACTUAL,2020-06-23,2020-06-23,ACTUAL,2020-06-23,,INTERVENTIONAL,,,A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma,"A Phase I Open-Label, Multicenter, Dose-Escalation Study of PRN1371, a FGFR 1-4 Kinase Inhibitor, in Adult Patients With Advanced Solid Tumors, Followed by an Expansion Cohort in Patients With Metastatic Urothelial Carcinoma With FGFR 1, 2, 3, or 4 Genetic Alterations",TERMINATED,,PHASE1,45.0,ACTUAL,"Principia Biopharma, a Sanofi Company",,1.0,,focus portfolio on immune-mediated diseases,f,,,,f,,,,,,,,,,,,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,INDUSTRY,,,,,,,2020,0.0
NCT02923986,,2016-09-12,,,2020-05-26,2016-10-03,2016-10-05,ESTIMATED,,,,,,,2020-05-26,2020-05-28,ACTUAL,2017-09-01,ACTUAL,2017-09-01,2020-05,2020-05-31,2020-05-27,ACTUAL,2020-05-27,2020-05-27,ACTUAL,2020-05-27,,INTERVENTIONAL,,,"Clinical Trial of BP1001 (Liposomal Grb2 Antisense Oligonucleotide) in Combination With Dasatinib in Patients With Ph + CML Who Have Failed TKI, Ph+ AML, Ph+ MDS","A Phase Ib/IIa Single-arm, Open-label Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination With Dasatinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML) Including Chronic Phase Patients Who Have Failed Initial Tyrosine Kinase Inhibitor (TKI) Therapy, Accelerated or Blast Phase, Ph+ Acute Myeloid Leukemia (AML) or High-risk Ph+ Myelodysplastic Syndrome (MDS)",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Bio-Path Holdings, Inc.",,2.0,,No enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,INDUSTRY,,,,,,,2020,0.0
NCT04899349,,2021-05-21,2023-11-22,,2024-10-07,2021-05-21,2021-05-24,ACTUAL,2023-11-22,2023-12-12,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2022-04-06,ACTUAL,2022-04-06,2024-10,2024-10-31,2023-05-10,ACTUAL,2023-05-10,2023-05-10,ACTUAL,2023-05-10,,INTERVENTIONAL,EPIK-B4,The trial was early terminated and no participants were randomized to the Alpelisib+Fulvestrant+Metformin XR arm.,"Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant","EPIK-B4: A Phase II, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR During Treatment With Alpelisib (BYL719) in Combination With Fulvestrant in Participants With HR+, HER2-, Advanced Breast Cancer With a PIK3CA Mutation Following Progression on/After Endocrine-based Therapy",TERMINATED,,PHASE2,2.0,ACTUAL,Novartis,,2.0,,Study was early terminated due to slow recruitment and emerging data showing that prophylactic use of metformin may prevent or reduce the incidence of all-grades alpelisib-related hyperglycemia. The decision was not driven by safety concerns,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2023,0.0
NCT02360371,,2015-01-29,2021-07-20,,2021-09-08,2015-02-05,2015-02-10,ESTIMATED,2021-09-08,2021-10-05,ACTUAL,,,,2021-09-08,2021-10-05,ACTUAL,2015-04,ACTUAL,2015-04-30,2021-09,2021-09-30,2021-05,ACTUAL,2021-05-31,2020-05,ACTUAL,2020-05-31,,INTERVENTIONAL,,,A118G SNP and OPRM1 Gene Opioid-Mediated Effects in Humans,A118G SNP and OPRM1 Gene Opioid-Mediated Effects in Humans,COMPLETED,,PHASE2,100.0,ACTUAL,Johns Hopkins University,,4.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,OTHER,,,,,,,2021,1.0
NCT03927911,,2019-04-19,2021-08-30,,2021-10-12,2019-04-23,2019-04-25,ACTUAL,2021-10-12,2021-11-09,ACTUAL,,,,2021-10-12,2021-11-09,ACTUAL,2019-07-31,ACTUAL,2019-07-31,2021-10,2021-10-31,2020-08-04,ACTUAL,2020-08-04,2020-08-04,ACTUAL,2020-08-04,,INTERVENTIONAL,FUSION,"Trial was terminated, not all arms had participants enrolled.",Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries,"A Multicenter, Prospective, Active Controlled, Real World, Phase 4 Study of EXPAREL in Multimodal Regimens Compared With Standard of Care for Postsurgical Pain Management in Subjects Undergoing Lumbar Posterior Spine Surgeries (FUSION)",TERMINATED,,PHASE4,65.0,ACTUAL,"Pacira Pharmaceuticals, Inc",,3.0,,Due to protocol feasibility given the rapid evolution of medical practice for spinal procedure. Data from approximately 65 FUSION study subjects will be analyzed with the intent to create either a future study or registry for this patient population.,f,,,,,t,f,,,t,,,,,,,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,INDUSTRY,,,,,,,2020,0.0
NCT03996473,,2019-06-21,2024-01-17,,2024-07-22,2019-06-21,2019-06-24,ACTUAL,2024-07-22,2024-10-10,ESTIMATED,,,,2024-07-22,2024-10-10,ESTIMATED,2020-03-06,ACTUAL,2020-03-06,2024-07,2024-07-31,2023-01-30,ACTUAL,2023-01-30,2021-04-14,ACTUAL,2021-04-14,,INTERVENTIONAL,,Safety analysis set (SAF): includes all participants who received at least 1 administration of study treatment.,Study to Test the Safety and How Radium-223 Dichloride an Alpha Particle-emitting Radioactive Agent Works in Combination With Pembrolizumab an Immune Checkpoint Inhibitor in Patients With Stage IV Non-small Cell Lung Cancer With Bone Metastases,"An Open-label, Multicenter, Phase 1/2 Study of Radium-223 Dichloride in Combination With Pembrolizumab in Participants With Stage IV Non-small Cell Lung Cancer",TERMINATED,,PHASE1,8.0,ACTUAL,Bayer,"The study was terminated early during the Phase 1 part of the study. This decision was based on strategic considerations also acknowledging the recruitment challenges for the first-line population. Due to the early termination, tumor responses were only listed, none of the efficacy outcome measures were actually analyzed.",4.0,,LPLV reached on 30Jan2023. Study was closed early for feasibility reasons related to enrollment of first line IO naïve patients. Safety data is consistent with the known safety profile of both drugs and no new safety issues have been observed,f,,,,t,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2023,0.0
NCT05502081,,2022-08-10,2022-08-18,,2023-07-11,2022-08-13,2022-08-16,ACTUAL,2023-02-18,2023-02-21,ACTUAL,,,,2023-07-11,2023-07-25,ACTUAL,2022-09-02,ACTUAL,2022-09-02,2023-07,2023-07-31,2022-12-28,ACTUAL,2022-12-28,2022-12-28,ACTUAL,2022-12-28,,INTERVENTIONAL,,,"Clinical Study to Compare Efficacy and Safety of Casirivimab and Imdevimab Combination, Remdesivir and Favipravir in Hospitalized COVID-19 Patients",Clinical Study to Evaluate the Possible Efficacy and Safety of Antibodies Combination (Casirivimab and Imdevimab) Versus Standard Antiviral Therapy (Remdesivir and Favipravir) as Antiviral Agent Against Corona Virus 2 Infection in Hospitalized COVID-19 Patients,COMPLETED,,PHASE4,265.0,ACTUAL,Mansoura University Hospital,"1. applicable only on hospitalized COVID-19 patients (not include outpatients),~2. non-randomization of antiviral drugs among included patients,~3. non-blinding of interventions to investigators",3.0,,,f,,,,t,t,f,,,,,,After the end and publication of the study,all will be accessiable,,YES,After the end and publication of the study,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,OTHER,,,,,,,2022,1.0
NCT03858634,,2019-02-27,2021-10-14,,2021-11-29,2019-02-27,2019-03-01,ACTUAL,2021-11-29,2021-12-28,ACTUAL,,,,2021-11-29,2021-12-28,ACTUAL,2019-05-29,ACTUAL,2019-05-29,2021-11,2021-11-30,2020-06-08,ACTUAL,2020-06-08,2020-04-01,ACTUAL,2020-04-01,,INTERVENTIONAL,,The baseline characteristics data are presented by combined cohorts for public reporting purposes because the low numbers of participants in the individual disease-specific cohorts may cause re-identification concerns if presented separately.,"A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases","KPL-716-C202: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Pilot Study to Investigate the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Diseases Characterized by Chronic Pruritus",COMPLETED,,PHASE2,58.0,ACTUAL,"Kiniksa Pharmaceuticals International, plc",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,INDUSTRY,,,,,,,2020,1.0
NCT04134728,,2019-10-18,2023-01-31,2022-08-05,2023-07-11,2019-10-18,2019-10-22,ACTUAL,2023-07-11,2023-07-17,ACTUAL,,2023-07-17,ACTUAL,2023-07-11,2023-07-17,ACTUAL,2019-10-31,ACTUAL,2019-10-31,2023-07,2023-07-31,2022-02-01,ACTUAL,2022-02-01,2021-09-15,ACTUAL,2021-09-15,,INTERVENTIONAL,contRAst 3,,Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors,"A 24-week, Phase 3, Multicentre, Randomised, Double-blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Sarilumab, in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological DMARDs and/or Janus Kinase Inhibitors",COMPLETED,,PHASE3,550.0,ACTUAL,GlaxoSmithKline,,6.0,,,f,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,INDUSTRY,,,,,,,2022,1.0
NCT02552212,,2015-09-15,2019-04-27,2019-03-01,2022-08-16,2015-09-15,2015-09-17,ESTIMATED,2020-07-31,2020-08-17,ACTUAL,2019-03-01,2019-03-05,ACTUAL,2022-08-16,2022-08-18,ACTUAL,2015-09,ACTUAL,2015-09-30,2022-08,2022-08-31,2020-05,ACTUAL,2020-05-31,2018-05,ACTUAL,2018-05-31,,INTERVENTIONAL,C-AXSPAND,Baseline Characteristics refer to the Randomized Set witch consisted of all subjects randomized into the study.,Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS,"Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis (axSpA) Without X-Ray Evidence of Ankylosing Spondylitis (AS) and Objective Signs of Inflammation",COMPLETED,,PHASE3,317.0,ACTUAL,UCB Pharma,,2.0,,,t,,,,f,,,,,,,,,,,,,2024-10-16 19:11:31.365492,2024-10-16 19:11:31.365492,INDUSTRY,,NCT03559686,AVAILABLE,,,,2020,1.0
NCT03004976,,2016-11-30,2022-07-20,2021-05-17,2022-11-08,2016-12-23,2016-12-29,ESTIMATED,2022-09-01,2022-09-23,ACTUAL,2022-09-01,2022-09-23,ACTUAL,2022-11-08,2022-12-06,ACTUAL,2017-03-14,ACTUAL,2017-03-14,2022-11,2022-11-30,2021-03-27,ACTUAL,2021-03-27,2020-07-17,ACTUAL,2020-07-17,,INTERVENTIONAL,CoBIS 2,,Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke,Phase 2 Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke - CoBIS 2,COMPLETED,,PHASE2,79.0,ACTUAL,Duke University,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,OTHER,,,,,,,2021,1.0
NCT04326790,,2020-03-26,,,2021-04-02,2020-03-26,2020-03-30,ACTUAL,,,,,,,2021-04-02,2021-04-06,ACTUAL,2020-04-03,ACTUAL,2020-04-03,2021-04,2021-04-30,2020-04-27,ACTUAL,2020-04-27,2020-04-27,ACTUAL,2020-04-27,,INTERVENTIONAL,GRECCO-19,,The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention,The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention,TERMINATED,,PHASE2,105.0,ACTUAL,National and Kapodistrian University of Athens,,2.0,,Slow enrollment as a result of the rapid flattening of the curve of COVID-19 cases in Greece,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,OTHER,,,,,,,2020,0.0
NCT04601324,,2020-10-19,,,2023-10-27,2020-10-22,2020-10-23,ACTUAL,,,,,,,2023-10-27,2023-10-31,ACTUAL,2020-12-15,ESTIMATED,2020-12-15,2023-10,2023-10-31,2021-07-01,ESTIMATED,2021-07-01,2021-06-01,ESTIMATED,2021-06-01,,INTERVENTIONAL,,,Allergic Rhinitis Combination Pharmacotherapy Efficacy Study,Randomized Controlled Trial Evaluating Combination Rupatadine and Fluticasone Propionate Compared to Azelastine Hydrochloride and Fluticasone Propionate in Treating Allergic Rhinitis,WITHDRAWN,,PHASE4,0.0,ACTUAL,St. Paul's Sinus Centre,,2.0,,PI did not pursue this study,f,,,,,t,f,,,t,,,,,,,,2024-10-15 23:41:43.345167,2024-10-15 23:41:43.345167,OTHER,,,,,,,2021,0.0
NCT02691026,,2016-02-04,,,2021-06-21,2016-02-23,2016-02-24,ESTIMATED,,,,,,,2021-06-21,2021-06-23,ACTUAL,2016-06,ACTUAL,2016-06-30,2021-06,2021-06-30,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,,,"A Study of Pembrolizumab in Patients With Malignant Peripheral Nerve Sheath Tumor (MPNST), Not Eligible for Curative Surgery","A Phase II Study of Pembrolizumab in Patients With Malignant Peripheral Nerve Sheath Tumor (MPNST), Not Eligible for Curative Surgery",TERMINATED,,PHASE2,8.0,ACTUAL,Oslo University Hospital,,1.0,,Slow enrollment as a result of low incidence of MPNST and the COVID-19 pandemic.,f,,,,f,,,,,,,,,,,NO,,2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,OTHER,,,,,,,2020,0.0
NCT03984812,,2019-06-10,2021-03-16,,2021-10-04,2019-06-10,2019-06-13,ACTUAL,2021-03-16,2021-04-12,ACTUAL,,,,2021-10-04,2021-10-25,ACTUAL,2019-06-17,ACTUAL,2019-06-17,2021-10,2021-10-31,2020-03-23,ACTUAL,2020-03-23,2020-03-23,ACTUAL,2020-03-23,,INTERVENTIONAL,,Only data for Part 1 is presented as study was terminated during Part 1; Part 2 was not initiated.,"Evaluation of the Safety, Tolerability and Pharmacokinetics (PK) of GSK3732394 First-Time-in-Human (FTIH) Study","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK3732394 in Healthy Participants",TERMINATED,,PHASE1,24.0,ACTUAL,ViiV Healthcare,,9.0,,The study was terminated early (following completion of SAD Cohort 3; 80 mg) based on PK/PD modelling which demonstrated the medicine's intended target profile was not achievable.,f,,,,f,t,f,,,,,,IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,INDUSTRY,,,,,,,2020,0.0
NCT04435314,,2020-06-08,,,2022-10-26,2020-06-16,2020-06-17,ACTUAL,,,,,,,2022-10-26,2022-10-28,ACTUAL,2020-06,ESTIMATED,2020-06-30,2022-10,2022-10-31,2020-08,ESTIMATED,2020-08-31,2020-08,ESTIMATED,2020-08-31,,INTERVENTIONAL,,,Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19,"Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg Three Times a Day for Post Exposure Prophylaxis of COVID-19 in Subjects From Vulnerable Communities",WITHDRAWN,,PHASE2,0.0,ACTUAL,Azidus Brasil,,2.0,,Sponsor's strategic decision,f,,,,f,f,f,,,,,,,,,NO,"It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.",2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,INDUSTRY,,,,,,,2020,0.0
NCT02271893,,2014-10-20,,,2022-10-06,2014-10-20,2014-10-22,ESTIMATED,,,,,,,2022-10-06,2022-10-10,ACTUAL,2014-11-25,ACTUAL,2014-11-25,2022-10,2022-10-31,2022-04-21,ACTUAL,2022-04-21,2017-10-26,ACTUAL,2017-10-26,,INTERVENTIONAL,CHEMODEX,,Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management,Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management,TERMINATED,,PHASE2,19.0,ACTUAL,"University Hospital, Clermont-Ferrand",,2.0,,Recruitment difficulties,f,,,,,,,,,,,,,,,,,2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,OTHER,,,,,,,2022,0.0
NCT02933255,,2016-10-13,2024-04-25,,2024-05-29,2016-10-13,2016-10-14,ESTIMATED,2024-05-29,2024-05-31,ACTUAL,,,,2024-05-29,2024-05-31,ACTUAL,2017-04-18,ACTUAL,2017-04-18,2024-05,2024-05-31,2023-12-01,ACTUAL,2023-12-01,2023-06-20,ACTUAL,2023-06-20,,INTERVENTIONAL,,,PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer,Phase I/II Study of PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer,COMPLETED,,PHASE1/PHASE2,24.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,,f,,,,f,t,f,,,,,,Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.,,YES,"All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).",2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,NIH,,,,,,,2023,1.0
NCT03548220,,2018-05-24,2021-10-08,,2022-05-20,2018-06-05,2018-06-07,ACTUAL,2022-05-20,2022-05-24,ACTUAL,,,,2022-05-20,2022-05-24,ACTUAL,2018-08-09,ACTUAL,2018-08-09,2022-05,2022-05-31,2020-10-09,ACTUAL,2020-10-09,2020-10-09,ACTUAL,2020-10-09,,INTERVENTIONAL,,Full analysis set included all participants who were randomized.,A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD),"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Subjects With Pyruvate Kinase Deficiency",COMPLETED,,PHASE3,80.0,ACTUAL,"Agios Pharmaceuticals, Inc.",,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:41:43.345167,2024-10-15 23:41:43.345167,INDUSTRY,,,,,,,2020,1.0
NCT04380090,,2020-05-05,2021-09-27,,2022-01-18,2020-05-05,2020-05-08,ACTUAL,2022-01-18,2022-01-19,ACTUAL,,,,2022-01-18,2022-01-19,ACTUAL,2020-02-21,ACTUAL,2020-02-21,2022-01,2022-01-31,2020-07-15,ACTUAL,2020-07-15,2020-07-15,ACTUAL,2020-07-15,,INTERVENTIONAL,,Participants who completed the study,Post-Operative Constipation Following Total Knee Arthroplasty,Efficacy of One Dose of Laxative on Post-Operative Constipation Following Total Knee Arthroplasty,COMPLETED,,PHASE2,154.0,ACTUAL,The Cleveland Clinic,"We did not consider, in this study, the amount of opioids used by patients postoperatively. An additional limitation was that only one dose of Miralax was used in the intervention group.",2.0,,,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,OTHER,,,,,,,2020,1.0
NCT03289143,,2017-09-18,2022-01-04,,2022-02-16,2017-09-18,2017-09-20,ACTUAL,2022-02-16,2022-03-16,ACTUAL,,,,2022-02-16,2022-03-16,ACTUAL,2017-10-04,ACTUAL,2017-10-04,2022-02,2022-02-28,2021-01-15,ACTUAL,2021-01-15,2021-01-15,ACTUAL,2021-01-15,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of Semorinemab in Patients With Prodromal to Mild Alzheimer's Disease,"A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Prodromal to Mild Alzheimer's Disease",TERMINATED,,PHASE2,457.0,ACTUAL,"Genentech, Inc.",,4.0,,Study was terminated during Open Label Extension period because analyses of placebo-controlled Blinded portion of study did not show any evidence of clinical efficacy or modulation of accumulation of tau PET signal at any of the doses studied.,f,,,,t,t,f,,,,,,,,,,,2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,INDUSTRY,,,,,,,2021,0.0
NCT03793686,,2018-12-27,,,2020-10-13,2019-01-03,2019-01-04,ACTUAL,,,,,,,2020-10-13,2020-10-19,ACTUAL,2018-12-06,ACTUAL,2018-12-06,2020-10,2020-10-31,2020-09-01,ACTUAL,2020-09-01,2020-09-01,ACTUAL,2020-09-01,,INTERVENTIONAL,,,A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea,"A Phase 1 Double Blind, Randomized Clinical Study to Evaluate the Safety of Human Milk Oligosaccharides Following Antibiotic Therapy in Subjects With C. Difficile-associated Diarrhea",TERMINATED,,PHASE1,26.0,ACTUAL,Prolacta Bioscience,,2.0,,Unable to enroll subjects,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,INDUSTRY,,,,,,,2020,0.0
NCT06353477,,2024-03-26,,,2024-04-02,2024-04-02,2024-04-09,ACTUAL,,,,,,,2024-04-02,2024-04-09,ACTUAL,2019-06-01,ACTUAL,2019-06-01,2024-04,2024-04-30,2023-01-01,ACTUAL,2023-01-01,2022-06-01,ACTUAL,2022-06-01,,INTERVENTIONAL,,,"Hand, Foot, and Mouth Disease: Could EPs®7630 be a Treatment Option","Use of EPs®7630 in Hand, Foot and Mouth Disease",COMPLETED,,PHASE2/PHASE3,240.0,ACTUAL,Eskisehir Osmangazi University,,2.0,,,f,,,,t,f,f,,,,,,March 2024- June 2024,researchers,https://www.cocukenfeksiyondernegi.org/,YES,EOU 2019-10,2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,OTHER,,,,,,,2023,1.0
NCT03313414,,2017-10-13,,,2020-01-16,2017-10-13,2017-10-18,ACTUAL,,,,,,,2020-01-16,2020-01-21,ACTUAL,2019-08-13,ACTUAL,2019-08-13,2020-01,2020-01-31,2020-01-16,ACTUAL,2020-01-16,2020-01,ESTIMATED,2020-01-31,,INTERVENTIONAL,,,HCV Post-Exposure Prophylaxis for Health Care Workers,Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers,WITHDRAWN,,PHASE4,0.0,ACTUAL,Massachusetts General Hospital,,1.0,,"No participant enrollment, funding withdrawn.",f,,,,f,t,f,,,f,,,,,,NO,no plan currently to share IPD with other researchers,2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,OTHER,,,,,,,2020,0.0
NCT05226546,,2022-02-03,,,2022-02-08,2022-02-03,2022-02-07,ACTUAL,,,,,,,2022-02-08,2022-02-25,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2022-02,2022-02-28,2021-08-01,ACTUAL,2021-08-01,2021-08-01,ACTUAL,2021-08-01,,INTERVENTIONAL,,,Effectiveness and Safety of Platelet Rich Plasma (PRP) on Persistent Olfactory Dysfunction Related to COVID-19,Effectiveness and Safety of Platelet Rich Plasma (PRP) on Persistent Olfactory Dysfunction Related to COVID-19: Towards a New Therapeutic Hope,COMPLETED,,PHASE2/PHASE3,56.0,ACTUAL,Centre Hospitalier Universitaire Saint Pierre,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,OTHER,,,,,,,2021,1.0
NCT03768427,,2018-11-29,2022-03-01,,2024-05-08,2018-12-06,2018-12-07,ACTUAL,2022-05-11,2023-02-08,ACTUAL,,,,2024-05-08,2024-05-16,ACTUAL,2019-05-27,ACTUAL,2019-05-27,2023-04,2023-04-30,2021-04-01,ACTUAL,2021-04-01,2021-03-17,ACTUAL,2021-03-17,,INTERVENTIONAL,,,Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439),"A Phase 3 Randomized, Active-comparator-controlled Clinical Study to Evaluate the Efficacy and Safety of Ezetimibe/Atorvastatin Combination Tablet (MK-0653C) as Second Line Lipid Lowering Treatment in Chinese Participants",COMPLETED,,PHASE3,454.0,ACTUAL,Organon and Co,,4.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,INDUSTRY,,,,,,,2021,1.0
NCT04784754,,2021-02-22,,,2022-07-19,2021-03-04,2021-03-05,ACTUAL,,,,,,,2022-07-19,2022-07-22,ACTUAL,2021-04-01,ACTUAL,2021-04-01,2022-07,2022-07-31,2022-12-31,ESTIMATED,2022-12-31,2022-09-30,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,Dose-Ranging Study to Assess the Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19,A Pilot Placebo-controlled Randomized Double-blind Trial of Melatonin in Outpatients With COVID-19 Infection,WITHDRAWN,,PHASE2,0.0,ACTUAL,State University of New York at Buffalo,,3.0,,lack of subject enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,OTHER,,,,,,,2022,0.0
NCT04715932,,2021-01-15,2022-02-22,,2022-04-06,2021-01-19,2021-01-20,ACTUAL,2022-04-06,2022-04-08,ACTUAL,,,,2022-04-06,2022-04-08,ACTUAL,2021-02-18,ACTUAL,2021-02-18,2022-04,2022-04-30,2021-06-07,ACTUAL,2021-06-07,2021-05-25,ACTUAL,2021-05-25,,INTERVENTIONAL,Hesperidin,,Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN),"A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Hesperidin Therapy on COVID-19 Symptoms: The Hesperidin Coronavirus Study (Hesperidin)",COMPLETED,,PHASE2,216.0,ACTUAL,Montreal Heart Institute,Only one dosage regimen of hesperidin was tested in this trial.,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,OTHER,,,,,,,2021,1.0
NCT03906643,,2019-04-05,,,2022-12-19,2019-04-05,2019-04-08,ACTUAL,,,,,,,2022-12-19,2022-12-20,ACTUAL,2020-07-15,ESTIMATED,2020-07-15,2022-12,2022-12-31,2023-02-20,ESTIMATED,2023-02-20,2023-01-15,ESTIMATED,2023-01-15,,INTERVENTIONAL,,,"HS-201, an HSP90 Inhibitor-linked Verteporfin for Detection of Solid Malignancies","A Phase I Study of HS-201, an HSP90 Inhibitor-linked Verteporfin for Detection of Solid Malignancies",WITHDRAWN,,PHASE1,0.0,ACTUAL,Duke University,,1.0,,Funding exhausted,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,OTHER,,,,,,,2023,0.0
NCT04209556,,2019-12-01,,,2020-12-15,2019-12-20,2019-12-24,ACTUAL,,,,,,,2020-12-15,2020-12-17,ACTUAL,2020-09-30,ESTIMATED,2020-09-30,2020-12,2020-12-31,2023-10-26,ESTIMATED,2023-10-26,2023-10-26,ESTIMATED,2023-10-26,,INTERVENTIONAL,,,A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis,"A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS",WITHDRAWN,,PHASE2,0.0,ACTUAL,Pfizer,,5.0,,The study was withdrawn following a strategic portfolio re-prioritization.,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,INDUSTRY,,,,,,,2023,0.0
NCT04360096,,2020-04-21,,,2023-02-02,2020-04-22,2020-04-24,ACTUAL,,,,,,,2023-02-02,2023-02-03,ACTUAL,2021-02-15,ACTUAL,2021-02-15,2021-11,2021-11-30,2021-12-31,ACTUAL,2021-12-31,2021-12-15,ACTUAL,2021-12-15,,INTERVENTIONAL,AVICOVID-2,,Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19,Inhaled ZYESAMI™ for the Treatment of Severe COVID-19,TERMINATED,,PHASE2/PHASE3,144.0,ACTUAL,APR Applied Pharma Research s.a.,,2.0,,Sponsor decision,f,,,,t,t,t,,,,,,,,,YES,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,OTHER,,,,,,,2021,0.0
NCT02452983,,2015-05-21,,,2022-05-31,2015-05-22,2015-05-25,ESTIMATED,,,,,,,2022-05-31,2022-06-02,ACTUAL,2015-05,,2015-05-31,2022-05,2022-05-31,2020-11,ACTUAL,2020-11-30,2020-11,ACTUAL,2020-11-30,,INTERVENTIONAL,SS1,,Sertraline in Treatment of Low-Risk Myelodysplastic Syndrome,SS1: Pilot Study of Sertraline in Treatment of Low-Risk Myelodysplastic Syndrome (MDS),TERMINATED,,PHASE1,14.0,ACTUAL,Baylor College of Medicine,,1.0,,This protocol is closed to further enrollment due to lack of study progress.,f,,,,t,,,,,,,,,,,,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,OTHER,,,,,,,2020,0.0
NCT03406078,,2018-01-14,2021-09-22,,2021-11-10,2018-01-14,2018-01-23,ACTUAL,2021-11-10,2021-12-09,ACTUAL,,,,2021-11-10,2021-12-09,ACTUAL,2018-03-05,ACTUAL,2018-03-05,2021-11,2021-11-30,2020-09-25,ACTUAL,2020-09-25,2020-09-25,ACTUAL,2020-09-25,,INTERVENTIONAL,SOURCE,,Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma,"A Multicentre, Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (SOURCE)",COMPLETED,,PHASE3,150.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared",2024-10-15 23:41:43.345167,2024-10-15 23:41:43.345167,INDUSTRY,,,,,,,2020,1.0
NCT04854889,,2021-04-14,,,2022-08-25,2021-04-19,2021-04-22,ACTUAL,,,,,,,2022-08-25,2022-08-30,ACTUAL,2021-04-22,ACTUAL,2021-04-22,2022-08,2022-08-31,2022-08-09,ACTUAL,2022-08-09,2022-07-26,ACTUAL,2022-07-26,,INTERVENTIONAL,LODACA,,Efficacy and Safety of Low-dose Decitabine in Refractory Aplastic Anemia,"Efficacy and Safety of Low-dose Decitabine in Refractory Aplastic Anemia (LODACA): a Phase 2, Single-arm, Open-label Study",TERMINATED,,PHASE2,3.0,ACTUAL,"Institute of Hematology & Blood Diseases Hospital, China",,1.0,,Not achieve the desired effect,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,OTHER,,,,,,,2022,0.0
NCT01823835,,2013-03-25,2021-02-23,,2021-05-25,2013-03-30,2013-04-04,ESTIMATED,2021-05-25,2021-06-18,ACTUAL,,,,2021-05-25,2021-06-18,ACTUAL,2014-12-29,ACTUAL,2014-12-29,2021-05,2021-05-31,2020-03-13,ACTUAL,2020-03-13,2020-03-13,ACTUAL,2020-03-13,,INTERVENTIONAL,,,A Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or a Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer,"An Open-Label, Phase Ia/Ib/IIa Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or an LHRH Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer",TERMINATED,,PHASE1/PHASE2,152.0,ACTUAL,"Genentech, Inc.",,15.0,,"The Sponsor decided to halt the development of GDC-0810, but not due to any safety concerns.",f,,,,,t,f,,,,,,,,,,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,INDUSTRY,,,,,,,2020,0.0
NCT02843451,,2016-07-21,,,2022-12-23,2016-07-21,2016-07-25,ESTIMATED,,,,,,,2022-12-23,2022-12-28,ACTUAL,2016-10,ACTUAL,2016-10-31,2022-12,2022-12-31,2023-10,ESTIMATED,2023-10-31,2023-10,ESTIMATED,2023-10-31,,INTERVENTIONAL,,,Milk Thistle in Body Dysmorphic Disorder,"Silymarin Treatment of Body Dysmorphic Disorder: A Double-Blind, Placebo-Controlled, Cross-Over Study",WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Chicago,,2.0,,Focus on other studies,f,,,,f,,,,,,,,,,,NO,,2024-10-15 23:41:43.345167,2024-10-15 23:41:43.345167,OTHER,,,,,,,2023,0.0
NCT03637491,,2018-08-10,2021-11-10,,2021-12-28,2018-08-16,2018-08-20,ACTUAL,2021-12-28,2022-01-26,ACTUAL,,,,2021-12-28,2022-01-26,ACTUAL,2018-08-15,ACTUAL,2018-08-15,2021-12,2021-12-31,2021-02-02,ACTUAL,2021-02-02,2020-12-03,ACTUAL,2020-12-03,,INTERVENTIONAL,,,"A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors","A PHASE 1B/2 STUDY TO EVALUATE SAFETY AND CLINICAL ACTIVITY OF COMBINATIONS OF AVELUMAB, BINIMETINIB AND TALAZOPARIB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC RAS-MUTANT SOLID TUMORS",TERMINATED,,PHASE1/PHASE2,36.0,ACTUAL,Pfizer,"Because there was a low probability of technical success for achieving target dose levels of the triplet combination while maintaining acceptable tolerability, and only limited anti-tumor activity was observed in this study of participants with mPDAC, a decision on the early termination was made on 14 December 2020. Phase 2 was not initiated, so PD-L1 Expression, DDR Gene Alterations, TMB and OR were not analyzed. Due to the low observed immunogenicity rate, nAb analysis was not conducted.",3.0,,Available clinical data has shown limited anti-tumor activity and reaching target study drug dose levels may not be feasible.,,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,INDUSTRY,,,,,,,2021,0.0
NCT05099536,,2021-10-11,,,2024-01-30,2021-10-19,2021-10-29,ACTUAL,,,,,,,2024-01-30,2024-01-31,ACTUAL,2022-02-24,ACTUAL,2022-02-24,2024-01,2024-01-31,2023-09-11,ACTUAL,2023-09-11,2023-09-11,ACTUAL,2023-09-11,,INTERVENTIONAL,,,3D011-08 Monotherapy in Subjects With Advanced Solid Tumors,"A Phase I Study of the Safety, Tolerability, Pharmacokinetics Profiles and Preliminary Efficacy of 3D011-08 for Injection Monotherapy in Subjects With Advanced Solid Tumors",WITHDRAWN,,PHASE1,0.0,ACTUAL,3D Medicines,,1.0,,Company's decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,INDUSTRY,,,,,,,2023,0.0
NCT04300881,,2019-11-21,,,2021-01-06,2020-03-04,2020-03-09,ACTUAL,,,,,,,2021-01-06,2021-01-08,ACTUAL,2019-10-04,ACTUAL,2019-10-04,2021-01,2021-01-31,2021-01-05,ACTUAL,2021-01-05,2021-01-05,ACTUAL,2021-01-05,,INTERVENTIONAL,TOTEM,,Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists),Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists): The TOTEM Study,TERMINATED,,PHASE2,2.0,ACTUAL,Wagner Macula & Retina Center,,2.0,,Enrollment,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,OTHER,,,,,,,2021,0.0
NCT04477525,,2020-07-13,,,2021-06-04,2020-07-15,2020-07-20,ACTUAL,,,,,,,2021-06-04,2021-06-08,ACTUAL,2021-06-22,ESTIMATED,2021-06-22,2021-06,2021-06-30,2022-06,ESTIMATED,2022-06-30,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,The Feasibility of Performing Erector Spinae (ESP) Nerve Block in Bariatric Patients; a Case Series Study,The Feasibility of Performing Erector Spinae (ESP) Nerve Block in Bariatric Patients; a Case Series Stud,WITHDRAWN,,PHASE2,0.0,ACTUAL,Montefiore Medical Center,,2.0,,PI changed hospital center,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,OTHER,,,,,,,2022,0.0
NCT02711735,,2016-02-25,,,2022-06-30,2016-03-16,2016-03-17,ESTIMATED,,,,,,,2022-06-30,2022-07-05,ACTUAL,2020-03-18,ACTUAL,2020-03-18,2022-06,2022-06-30,2020-09-09,ACTUAL,2020-09-09,2020-09-09,ACTUAL,2020-09-09,,INTERVENTIONAL,,,Safety of RUTI® Vaccination in MDR-TB Patients,"Double-Blind, Randomized, Placebo-Controlled Phase IIa Clinical Trial to Investigate the Safety and Immunogenicity of RUTI® Therapeutic Vaccination in Patients With MDR-TB After Successful Intensive-phase Treatment.",TERMINATED,,PHASE2,9.0,ACTUAL,Archivel Farma S.L.,,2.0,,Lack of recruitment,f,,,,t,f,f,,,,,,,,,YES,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,INDUSTRY,,,,,,,2020,0.0
NCT02675439,,2016-02-02,,,2021-12-10,2016-02-03,2016-02-05,ESTIMATED,,,,,,,2021-12-10,2021-12-30,ACTUAL,2016-04-28,ACTUAL,2016-04-28,2021-12,2021-12-31,2020-08-06,ACTUAL,2020-08-06,2019-12-11,ACTUAL,2019-12-11,,INTERVENTIONAL,,,Safety and Efficacy of MIW815 (ADU-S100) +/- Ipilimumab in Patients With Advanced/Metastatic Solid Tumors or Lymphomas,"A Phase I, Open Label, Multicenter Study of the Safety and Efficacy of MIW815 (ADU-S100) Administered by Intratumoral Injection to Patients With Advanced/Metastatic Solid Tumors or Lymphomas",TERMINATED,,PHASE1,47.0,ACTUAL,"Chinook Therapeutics, Inc.",,2.0,,No substantial anti-tumor activity was observed.,f,,,,,,,,,,,,,,,,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,INDUSTRY,,,,,,,2020,0.0
NCT04601610,,2020-10-19,,,2022-10-26,2020-10-22,2020-10-26,ACTUAL,,,,,,,2022-10-26,2022-10-28,ACTUAL,2021-06-07,ACTUAL,2021-06-07,2022-05,2022-05-31,2022-05-30,ACTUAL,2022-05-30,2022-05-30,ACTUAL,2022-05-30,,INTERVENTIONAL,,,KN046 Combined With Ningatinib in the Treatment of Advanced Hepatocellular Carcinoma,"An Open, Multi-center, Ib/II Clinical Trial of KN046 Combined With Ningatinib in the Treatment of Advanced Hepatocellular Carcinoma",TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,"Jiangsu Alphamab Biopharmaceuticals Co., Ltd",,2.0,,The sponsor's development strategy adjustment resolution is terminated,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,INDUSTRY,,,,,,,2022,0.0
NCT03856112,,2019-02-22,,,2019-03-25,2019-02-25,2019-02-27,ACTUAL,,,,,,,2019-03-25,2019-03-26,ACTUAL,2019-06-21,ESTIMATED,2019-06-21,2019-03,2019-03-31,2021-12-31,ESTIMATED,2021-12-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Ixazomib and Dexamethasone With or Without Venetoclax in Treating Patients With Non-t(11;14) Relapsed or Refractory Multiple Myeloma,"A Phase 1/2 Study of MLN9708 (Ixazomib [I]), Venetoclax (V), and Dexamethasone (D) Regimen (IVD) to Restore or Enhance Proteasome Inhibitor (PI) Sensitivity in Non-t(11;14) Relapsed/Refractory Multiple Myeloma (RRMM)",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,National Cancer Institute (NCI),,3.0,,"Per CTEP, Martha Khrum this study is withdrawn. Changing status to update CT.gov",,,,,f,t,f,,,,,,,,,,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,NIH,,,,,,,2021,0.0
NCT02527564,,2015-08-17,2022-08-09,,2022-10-03,2015-08-18,2015-08-19,ESTIMATED,2022-10-03,2022-10-06,ACTUAL,,,,2022-10-03,2022-10-06,ACTUAL,2015-09,,2015-09-30,2022-10,2022-10-31,2021-03-01,ACTUAL,2021-03-01,2021-03-01,ACTUAL,2021-03-01,,INTERVENTIONAL,,Participants who received the allocated intervention are included in the analysis,Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder,"A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Suvorexant for Treatment-resistant Insomnia in Patients With Bipolar Disorder",COMPLETED,,PHASE4,61.0,ACTUAL,Stanford University,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,OTHER,,,,,,,2021,1.0
NCT03597503,,2018-07-12,2024-01-04,,2024-04-18,2018-07-12,2018-07-24,ACTUAL,2024-02-16,2024-02-20,ACTUAL,,,,2024-04-18,2024-04-24,ACTUAL,2018-07-31,ACTUAL,2018-07-31,2024-04,2024-04-30,2020-01-22,ACTUAL,2020-01-22,2020-01-22,ACTUAL,2020-01-22,,INTERVENTIONAL,,"Baseline Participants is based on the Safety Population, defined as all subjects who received at least 1 dose of study drug and had at least one post-baseline safety assessment.",Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment,Assessment of Efficacy and Safety of SPN-810 for the Treatment of Impulsive Aggression (IA) in Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment,TERMINATED,,PHASE3,41.0,ACTUAL,"Supernus Pharmaceuticals, Inc.",,2.0,,"Business decision, not related to safety",f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,INDUSTRY,,,,,,,2020,0.0
NCT03959345,,2019-05-20,,,2022-04-13,2019-05-20,2019-05-22,ACTUAL,,,,,,,2022-04-13,2022-04-21,ACTUAL,2019-05-31,ACTUAL,2019-05-31,2022-04,2022-04-30,2022-02-24,ACTUAL,2022-02-24,2022-02-24,ACTUAL,2022-02-24,,INTERVENTIONAL,SAFO,,Efficacy of Cloxacillin and Fosfomycin Combination Versus Cloxacillin Monotherapy in Patients With MSSA Bacteremia,"Multicenter, Randomised, Open-label Phase III-IV Study to Evaluate the Efficacy of Cloxacillin and Fosfomycin Combination Versus Cloxacillin Monotherapy in Patients With Methicillin-susceptible Staphylococcus Aureus Bacteraemia: SAFO Trial",TERMINATED,,PHASE4,215.0,ACTUAL,Institut d'Investigació Biomèdica de Bellvitge,,2.0,,"Data safety and monitoring board(DSMB) have been performed when half of sample size (SS)have been reached. Recruitment was slower than expected so SS was recalculated. After analysis of data, DSMB recommended to stop study.",f,,,,,f,f,,,f,,,immediately following publication and ending 5 years following article publication,Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.,,YES,"Sharing of data generated by this project is an essential part of our proposed activities and will be carried out in several different ways. We would wish to make our results available both to the community of scientists interested in infectious diseases and the biology of Staphylococcus aureus to avoid unintentional duplication of research.~The preliminary results will be presented at international and national infectious diseases conferences and will be published in peer-reviewed journals. The results will also be made available through press and social media communications. Any formal presentation or publication of data collected from this study will be considered as a joint publication by the participating investigators and will follow the recommendations of the ICMJE. Individual participant data that underlie the results, after deidentification will be available. Proposals should be directed to the corresponding author.",2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,OTHER,,,,,,,2022,0.0
NCT04007991,,2019-07-02,2023-09-08,2022-04-19,2023-09-08,2019-07-02,2019-07-05,ACTUAL,2023-09-08,2023-10-04,ACTUAL,2022-04-19,2022-04-21,ACTUAL,2023-09-08,2023-10-04,ACTUAL,2019-06-28,ACTUAL,2019-06-28,2023-09,2023-09-30,2021-09-23,ACTUAL,2021-09-23,2021-09-23,ACTUAL,2021-09-23,,INTERVENTIONAL,D1AMOND,The Safety Set included all participants who received at least one dose of study drug.,Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents,"Multicenter, Placebo-Controlled, Double-Blind, Randomized, Parallel-Group, Phase 2b Study to Evaluate the Efficacy and Safety of Ecopipam in Children and Adolescents With Tourette's Syndrome",COMPLETED,,PHASE2,153.0,ACTUAL,Emalex Biosciences Inc.,,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,INDUSTRY,,,,,,,2021,1.0
NCT05005312,,2021-08-05,2022-10-24,,2022-10-24,2021-08-05,2021-08-13,ACTUAL,2022-10-24,2023-09-06,ACTUAL,,,,2022-10-24,2023-09-06,ACTUAL,2021-08-31,ACTUAL,2021-08-31,2022-10,2022-10-31,2021-12-07,ACTUAL,2021-12-07,2021-12-07,ACTUAL,2021-12-07,,INTERVENTIONAL,,All enrolled participants who received at least one dose of study intervention.,Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332,"A PHASE 1, NON-RANDOMIZED, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07321332 BOOSTED WITH RITONAVIR IN ADULT PARTICIPANTS WITH MODERATE HEPATIC IMPAIRMENT AND HEALTHY PARTICIPANTS WITH NORMAL HEPATIC FUNCTION",COMPLETED,,PHASE1,17.0,ACTUAL,Pfizer,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,INDUSTRY,,,,,,,2021,1.0
NCT02066649,,2014-02-17,,,2018-07-20,2014-02-17,2014-02-19,ESTIMATED,,,,,,,2018-07-20,2018-07-24,ACTUAL,2018-07,ESTIMATED,2018-07-31,2018-07,2018-07-31,2021-09,ESTIMATED,2021-09-30,2019-03,ESTIMATED,2019-03-31,,INTERVENTIONAL,,,Carvedilol vs Band Ligation vs Combination Therapy for Primary Prophylaxis of Variceal Bleeding,A Phase 3 Study of Carvedilol vs Variceal Band Ligation vs Combination Therapy for Primary Prophylaxis of Variceal Bleeding,WITHDRAWN,,PHASE3,0.0,ACTUAL,"Rutgers, The State University of New Jersey",,3.0,,We need to revise and redesign the study,f,,,,f,t,f,,,f,,,,,,,,2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,OTHER,,,,,,,2021,0.0
NCT04938323,,2021-05-28,,,2022-06-30,2021-06-23,2021-06-24,ACTUAL,,,,,,,2022-06-30,2022-07-06,ACTUAL,2022-05,ESTIMATED,2022-05-31,2022-06,2022-06-30,2022-09,ESTIMATED,2022-09-30,2022-07,ESTIMATED,2022-07-31,,INTERVENTIONAL,,,Prevention of Acute Respiratory Infection in Taiwanese Institutionalized Elderly,Prevention of Acute Respiratory Infection in Taiwanese Institutionalized Elderly (PARITIE),WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Harvard Medical School (HMS and HSDM),,2.0,,Covid-19 related delays in project launch,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,OTHER,,,,,,,2022,0.0
NCT05365100,,2022-04-26,,,2023-03-23,2022-05-04,2022-05-09,ACTUAL,,,,,,,2023-03-23,2023-03-24,ACTUAL,2022-07,ESTIMATED,2022-07-31,2023-03,2023-03-31,2024-07-30,ESTIMATED,2024-07-30,2024-07-30,ESTIMATED,2024-07-30,,INTERVENTIONAL,,,A Study of BN102 in Patients With Previously Treated CLL/SLL and B-cell NHL,A Multicenter Phase 1/2 Clinical Study to Evaluate the Safety and Efficacy of BN102 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and B-cell Non-Hodgkin's Lymphoma (NHL),WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,BioNova Pharmaceuticals (Shanghai) LTD.,,7.0,,Due to company decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,INDUSTRY,,,,,,,2024,0.0
NCT02466685,,2015-06-04,2023-03-21,,2023-10-30,2015-06-08,2015-06-09,ESTIMATED,2023-06-14,2023-07-03,ACTUAL,,,,2023-10-30,2023-11-14,ACTUAL,2015-09,,2015-09-30,2023-10,2023-10-31,2022-12,ACTUAL,2022-12-31,2021-09,ACTUAL,2021-09-30,,INTERVENTIONAL,,,Testing the Ability of JNJ-18038683 to Improve Cognition and Reduce Depressive Symptoms in Stable Bipolar Patients,"Testing the Ability of JNJ(Janssen and Janssen)18038683, a Selective Serotonin (5-HT)7 Antagonist, to Improve Cognition and Reduce Residual Depressive Symptoms in Stable Bipolar Patients (18038683BCD2001)",COMPLETED,,PHASE2,60.0,ACTUAL,Northwestern University,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,OTHER,,,,,,,2022,1.0
NCT03559270,,2018-06-06,2022-10-11,,2022-10-11,2018-06-06,2018-06-18,ACTUAL,2022-10-11,2022-11-08,ACTUAL,,,,2022-10-11,2022-11-08,ACTUAL,2018-06-27,ACTUAL,2018-06-27,2022-10,2022-10-31,2022-06-13,ACTUAL,2022-06-13,2021-10-14,ACTUAL,2021-10-14,,INTERVENTIONAL,BREEZE-AD6,Modified intent-to-treat (mITT) population included all participants who received at least one dose of study drug.,A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis,"A Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis",TERMINATED,,PHASE3,374.0,ACTUAL,Eli Lilly and Company,"The trial was terminated before completion, due to lack of alignment during regulatory negotiations.",4.0,,Terminated due to lack of alignment during regulatory negotiations.,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,INDUSTRY,,,,,,,2022,0.0
NCT02737501,,2016-03-30,2021-07-27,,2021-07-27,2016-04-11,2016-04-14,ESTIMATED,2021-07-27,2021-08-20,ACTUAL,,,,2021-07-27,2021-08-20,ACTUAL,2016-05-26,ACTUAL,2016-05-26,2021-07,2021-07-31,2021-01-29,ACTUAL,2021-01-29,2020-07-28,ACTUAL,2020-07-28,,INTERVENTIONAL,ALTA-1L,"Intent-to-treat (ITT) Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose.",ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants,A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) Versus Crizotinib in Patients With ALK-positive Advanced Lung Cancer,COMPLETED,,PHASE3,275.0,ACTUAL,Takeda,,3.0,,,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,INDUSTRY,,,,,,,2021,1.0
NCT04773587,,2021-02-24,2024-08-02,2023-07-25,2024-09-13,2021-02-24,2021-02-26,ACTUAL,2024-09-13,2024-10-09,ACTUAL,,2024-10-09,ACTUAL,2024-09-13,2024-10-09,ACTUAL,2021-01-27,ACTUAL,2021-01-27,2024-09,2024-09-30,2022-08-30,ACTUAL,2022-08-30,2022-08-30,ACTUAL,2022-08-30,,INTERVENTIONAL,INTEGUMENT-I,,Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis,"A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects With Atopic Dermatitis",COMPLETED,,PHASE3,654.0,ACTUAL,"Arcutis Biotherapeutics, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2022,1.0
NCT04366713,,2020-03-23,2022-11-23,,2023-01-13,2020-04-24,2020-04-29,ACTUAL,2023-01-13,2023-02-10,ACTUAL,,,,2023-01-13,2023-02-10,ACTUAL,2020-06-30,ACTUAL,2020-06-30,2023-01,2023-01-31,2021-12-28,ACTUAL,2021-12-28,2021-12-28,ACTUAL,2021-12-28,,INTERVENTIONAL,,Safety population (treated patients),A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib,An Open-Label Phase 2 Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib,COMPLETED,,PHASE2,6.0,ACTUAL,"Puma Biotechnology, Inc.",,1.0,,,f,,,,f,t,f,,,,,,"Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.","Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.~Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.",https://pumabiotechnology.com/data_sharing_policy.html,YES,"Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.~In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.~Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.~Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.",2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,INDUSTRY,,,,,,,2021,1.0
NCT03363165,,2017-11-30,2024-02-09,,2024-05-02,2017-11-30,2017-12-06,ACTUAL,2024-05-02,2024-05-30,ACTUAL,,,,2024-05-02,2024-05-30,ACTUAL,2018-01-01,ACTUAL,2018-01-01,2024-05,2024-05-31,2023-09-05,ACTUAL,2023-09-05,2023-02-10,ACTUAL,2023-02-10,,INTERVENTIONAL,HI-PAD,,Hepatocyte Growth Factor to Improve Functioning in PAD,Hepatocyte Growth Factor to Improve Functioning in Peripheral Artery Disease: The HI-PAD Study,COMPLETED,,PHASE2,39.0,ACTUAL,Northwestern University,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:28:22.009988,2024-10-16 09:28:22.009988,OTHER,,,,,,,2023,1.0
NCT04446312,,2020-06-22,2023-09-29,,2023-10-25,2020-06-22,2020-06-24,ACTUAL,2023-10-25,2023-10-27,ACTUAL,,,,2023-10-25,2023-10-27,ACTUAL,2020-07-13,ACTUAL,2020-07-13,2023-10,2023-10-31,2021-02-05,ACTUAL,2021-02-05,2021-01-07,ACTUAL,2021-01-07,,INTERVENTIONAL,,The Baseline Analysis Population represents the Intent-to-Treat Population which includes all patients that were dispensed a study preparation kit.,Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy,A Safety and Efficacy Comparison of BLI4900 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy,COMPLETED,,PHASE3,500.0,ACTUAL,Braintree Laboratories,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,INDUSTRY,,,,,,,2021,1.0
NCT03801889,,2019-01-08,,,2020-09-30,2019-01-10,2019-01-14,ACTUAL,,,,,,,2020-09-30,2020-10-05,ACTUAL,2020-08,ESTIMATED,2020-08-31,2020-09,2020-09-30,2023-01,ESTIMATED,2023-01-31,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,SP-420 in Subjects With Transfusion-dependent Beta-Thalassemia or Other Rare Anemias,"Multicenter, Open-label, 52 Week, Dose-escalation Study of SP 420 in Subjects With Transfusion-dependent Beta-Thalassemia or Other Rare Anemias",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Abfero Pharmaceuticals, Inc",,3.0,,Protocol suspended prior to patient enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,INDUSTRY,,,,,,,2023,0.0
NCT02826772,,2016-06-23,,,2020-03-13,2016-07-05,2016-07-11,ESTIMATED,,,,,,,2020-03-13,2020-03-17,ACTUAL,2016-02-10,ACTUAL,2016-02-10,2020-03,2020-03-31,2020-02-15,ACTUAL,2020-02-15,2019-05-15,ACTUAL,2019-05-15,,INTERVENTIONAL,,,"Safety, Tolerability, and PK of GT0918 (Proxalutamide) in Subjects With Metastatic Castrate Prostate Cancer","A Phase 1/2, Multi-Center, Open-Label, Two-Stage Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GT0918 in Subjects With Metastatic Castrate Resistant Prostate Cancer (mCRPC)",COMPLETED,,PHASE1,40.0,ACTUAL,"Suzhou Kintor Pharmaceutical Inc,",,1.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,INDUSTRY,,,,,,,2020,1.0
NCT04495283,,2020-07-27,2021-09-01,,2021-10-25,2020-07-29,2020-07-31,ACTUAL,2021-10-25,2021-11-23,ACTUAL,,,,2021-10-25,2021-11-23,ACTUAL,2020-07-28,ACTUAL,2020-07-28,2021-10,2021-10-31,2020-11-12,ACTUAL,2020-11-12,2020-11-12,ACTUAL,2020-11-12,,INTERVENTIONAL,,"The Safety Analysis Set included all subjects who received any amount of study drug (APAP + PGB, APAP, or placebo), whether or not they were prematurely withdrawn from the study.",A Phase 2 Study to Evaluate Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy,"A Phase 2, Randomized, Double-Blind, Placebo- and Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Combination of Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy",COMPLETED,,PHASE2,87.0,ACTUAL,"Nevakar, Inc.",,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,INDUSTRY,,,,,,,2020,1.0
NCT04740814,,2021-02-02,2023-01-24,,2024-02-09,2021-02-02,2021-02-05,ACTUAL,2023-01-24,2023-11-13,ACTUAL,,,,2024-02-09,2024-02-12,ACTUAL,2021-02-11,ACTUAL,2021-02-11,2024-02,2024-02-29,2022-06-27,ACTUAL,2022-06-27,2022-01-24,ACTUAL,2022-01-24,,INTERVENTIONAL,,Baseline Characteristics refer to the Safety Set (SS) which consisted of all study participants enrolled who received greater than or equal to (≥) 1 injection of study medication.,A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis,"A Multi-Center, Open-Label Study to Evaluate the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis Using an Electrochemiluminescent Immuno-Assay",COMPLETED,,PHASE1,33.0,ACTUAL,UCB Pharma,,1.0,,,f,,,,f,t,f,,,f,,,,,,NO,"Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.",2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,INDUSTRY,,,,,,,2022,1.0
NCT04592341,,2020-10-02,2024-01-10,,2024-03-01,2020-10-14,2020-10-19,ACTUAL,2024-03-01,2024-03-27,ACTUAL,,,,2024-03-01,2024-03-27,ACTUAL,2020-11-18,ACTUAL,2020-11-18,2024-02,2024-02-29,2023-03-15,ACTUAL,2023-03-15,2023-01-11,ACTUAL,2023-01-11,,INTERVENTIONAL,,"Intent-to-treat (ITT) population set, included all enrolled participants (i.e., who gave informed consent, did not fail screening, and had at least one Amyloid PET scan with a valid quantitative measurement performed with either florbetaben or flutemetamol), whether or not the participant received the assigned treatment.",A Study to Evaluate the Pharmacodynamic (PD) Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer's Disease (AD),"A Phase II, Multicenter, Open-Label, Single Arm Study to Evaluate the Pharmacodynamic Effects of Once Weekly Administration of Gantenerumab in Participants With Early (Prodromal to Mild) Alzheimer's Disease",TERMINATED,,PHASE2,192.0,ACTUAL,Hoffmann-La Roche,,1.0,,Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early-stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I\&II (WN29922/WN39658).,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-14 22:15:13.16685,2024-10-14 22:15:13.16685,INDUSTRY,,,,,,,2023,0.0
NCT04801641,,2021-03-04,,,2024-01-25,2021-03-12,2021-03-17,ACTUAL,,,,,,,2024-01-25,2024-01-29,ACTUAL,2021-09-17,ACTUAL,2021-09-17,2024-01,2024-01-31,2023-08-14,ACTUAL,2023-08-14,2023-08-14,ACTUAL,2023-08-14,,INTERVENTIONAL,,,A Pilot Trial of Nabilone for the Treatment of Obesity,"Impact of Chronic Nabilone Self-administration on Body Weight, Metabolic Markers, Gut Microbiota, and Neural Circuitry in Human Obesity",TERMINATED,,PHASE2,24.0,ACTUAL,Centre for Addiction and Mental Health,,3.0,,Poor tolerability of medication and no preliminary efficacy,f,,,,f,f,f,,,,,,,,,,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,OTHER,,,,,,,2023,0.0
NCT04483297,,2020-07-14,,,2024-03-03,2020-07-22,2020-07-23,ACTUAL,,,,,,,2024-03-03,2024-03-06,ACTUAL,2020-11-18,ACTUAL,2020-11-18,2024-03,2024-03-31,2024-01-30,ACTUAL,2024-01-30,2023-11-27,ACTUAL,2023-11-27,,INTERVENTIONAL,ENHANCE,,First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS),First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS) In Subjects With Degenerative Spondylolisthesis and Concomitant Symptomatic Spinal Stenosis Who Are Undergoing Decompression And Single Level Instrumented Posterolateral Lumbar Autograft Fusion Surgery,TERMINATED,,PHASE1,30.0,ACTUAL,Asahi Kasei Pharma Corporation,,2.0,,Sponsor decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,INDUSTRY,,,,,,,2024,0.0
NCT02299414,,2014-10-28,2023-04-04,,2023-05-16,2014-11-19,2014-11-24,ESTIMATED,2023-05-16,2023-05-17,ACTUAL,,,,2023-05-16,2023-05-17,ACTUAL,2015-06,ACTUAL,2015-06-30,2023-05,2023-05-31,2022-12-16,ACTUAL,2022-12-16,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,CHAP,,Chronic Hypertension and Pregnancy (CHAP) Project,A Pragmatic Multicenter Randomized Clinical Trial (RCT) of Antihypertensive Therapy for Mild Chronic Hypertension During Pregnancy: Chronic Hypertension and Pregnancy (CHAP) Project,COMPLETED,,PHASE4,2408.0,ACTUAL,University of Alabama at Birmingham,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,OTHER,,,,,,,2022,1.0
NCT03447769,,2018-02-19,2023-12-27,2023-02-28,2024-10-07,2018-02-21,2018-02-27,ACTUAL,2024-01-25,2024-01-30,ACTUAL,,2024-01-30,ACTUAL,2024-10-07,2024-10-09,ACTUAL,2018-03-16,ACTUAL,2018-03-16,2024-10,2024-10-31,2023-02-07,ACTUAL,2023-02-07,2022-03-17,ACTUAL,2022-03-17,,INTERVENTIONAL,Canopy-A,,Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A,"A Phase III, Multicenter, Randomized, Double Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Canakinumab Versus Placebo as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II -IIIA and IIIB (T>5cm N2) Completely Resected (R0) Non-small Cell Lung Cancer (NSCLC)",TERMINATED,,PHASE3,1382.0,ACTUAL,Novartis,,2.0,,"Upon review of the primary analysis results, the benefit-risk was assessed by the Steering Committee Members with the decision that the study will be closed. No new safety signals were observed for canakinumab.",f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data will be available according to the process described on www.clinicalstudydatarequest.com.",2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2023,0.0
NCT02043587,,2014-01-21,,,2022-04-26,2014-01-21,2014-01-23,ESTIMATED,,,,,,,2022-04-26,2022-05-02,ACTUAL,2014-01,,2014-01-31,2022-04,2022-04-30,2022-04-14,ACTUAL,2022-04-14,2022-04-14,ACTUAL,2022-04-14,,INTERVENTIONAL,,,Chemotherapy With Liposomal Cytarabine CNS Prophylaxis for Adult Acute Lymphoblastic Leukemia & Lymphoblastic Lymphoma,"A Phase II Study of Punctual, Cyclic, and Intensive Chemotherapy With Liposomal Cytarabine (Depocyt®) CNS Prophylaxis for Adults With Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma",TERMINATED,,PHASE2,31.0,ACTUAL,"University of California, San Diego",,1.0,,Original investigator for the trial has left,f,,,,t,,,,,,,,,,,,,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,OTHER,,,,,,,2022,0.0
NCT04610879,,2019-07-09,,,2020-10-26,2020-10-26,2020-11-02,ACTUAL,,,,,,,2020-10-26,2020-11-02,ACTUAL,2019-08-02,ACTUAL,2019-08-02,2020-10,2020-10-31,2020-09-23,ACTUAL,2020-09-23,2020-09-23,ACTUAL,2020-09-23,,INTERVENTIONAL,CASTLE,,"Changing Agendas on Sleep, Treatment and Learning in Epilepsy","Randomised Factorial Design Controlled Trial Comparing Carbamazepine, Levetiracetam or Active Monitoring Combined With or Without Sleep Behaviour Intervention in Treatment Naive Children With Rolandic Epilepsy",TERMINATED,,PHASE4,5.0,ACTUAL,King's College London,,6.0,,"Following the internal pilot, the study did not meet prespecified stop/go criteria for continuation.",f,,,,t,f,f,,,f,,,,,,UNDECIDED,The current data sharing plans for this study are unknown and will be available at a later date,2024-10-16 19:18:50.30232,2024-10-16 19:18:50.30232,OTHER,,,,,,,2020,0.0
NCT05799495,,2023-04-04,2024-09-12,,2024-09-12,2023-04-04,2023-04-05,ACTUAL,2024-09-12,2024-10-09,ACTUAL,,,,2024-09-12,2024-10-09,ACTUAL,2023-05-23,ACTUAL,2023-05-23,2024-09,2024-09-30,2023-10-11,ACTUAL,2023-10-11,2023-09-13,ACTUAL,2023-09-13,,INTERVENTIONAL,,The full analysis set (FAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention Participants were analyzed according to the intervention they were actually randomized.,A Study to Understand the Effect and Safety of the Study Medicine PF-07817883 in Adults Who Have Symptoms of COVID-19 But Are Not Hospitalized,"A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY TO EVALUATE VIROLOGICAL RESPONSE AND SAFETY OF ORAL PF-07817883 IN NON-HOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19",COMPLETED,,PHASE2,240.0,ACTUAL,Pfizer,,4.0,,,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2023,1.0
NCT03923959,,2019-04-18,2024-05-24,,2024-10-08,2019-04-22,2019-04-23,ACTUAL,2024-10-08,2024-10-10,ESTIMATED,,,,2024-10-08,2024-10-10,ESTIMATED,2020-02-01,ACTUAL,2020-02-01,2024-10,2024-10-31,2022-12-09,ACTUAL,2022-12-09,2022-12-09,ACTUAL,2022-12-09,,INTERVENTIONAL,TAHFT,Participant enrolled twice for separate hip fractures - one enrollment removed.,Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population,Evaluation of Tranexamic Acid Prior to Surgery in the Geriatric Hip Fracture Population for the Reduction of Post-Operative Blood Transfusion,COMPLETED,,PHASE3,283.0,ACTUAL,Lancaster General Hospital,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,OTHER,,,,,,,2022,1.0
NCT05030584,,2021-08-27,,2024-03-13,2024-03-13,2021-08-27,2021-09-01,ACTUAL,,,,,2024-03-15,ACTUAL,2024-03-13,2024-03-15,ACTUAL,2021-08-27,ACTUAL,2021-08-27,2024-03,2024-03-31,2024-02-12,ACTUAL,2024-02-12,2023-03-29,ACTUAL,2023-03-29,,INTERVENTIONAL,OASIS-3,,A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause,"A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 52 Weeks in Postmenopausal Women",COMPLETED,,PHASE3,628.0,ACTUAL,Bayer,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,INDUSTRY,,,,,,,2024,1.0
NCT05478252,,2022-07-26,2024-08-07,,2024-09-16,2022-07-26,2022-07-28,ACTUAL,2024-09-16,2024-10-09,ACTUAL,,,,2024-09-16,2024-10-09,ACTUAL,2022-08-03,ACTUAL,2022-08-03,2024-09,2024-09-30,2023-09-18,ACTUAL,2023-09-18,2023-08-09,ACTUAL,2023-08-09,,INTERVENTIONAL,,Full analysis set (FAS) included all randomized participants,A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes,Investigation of Clinical Comparability of Semaglutide Drug Products Based on the Proposed and the Approved Drug Substance Manufacturing Processes in Participants With Type 2 Diabetes,COMPLETED,,PHASE3,388.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,INDUSTRY,,,,,,,2023,1.0
NCT02808429,,2016-06-16,2021-02-04,,2021-02-04,2016-06-16,2016-06-21,ESTIMATED,2021-02-04,2021-02-25,ACTUAL,,,,2021-02-04,2021-02-25,ACTUAL,2017-01-31,ACTUAL,2017-01-31,2021-01,2021-01-31,2020-02-07,ACTUAL,2020-02-07,2020-02-07,ACTUAL,2020-02-07,,INTERVENTIONAL,,The modified intent-to-treat (mITT) population included all randomized participants who had received at least 1 dose of the Investigational Medicinal Product (IMP).,Efficacy and Safety of Atacicept in IgA Nephropathy,"A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy",TERMINATED,,PHASE2,16.0,ACTUAL,EMD Serono,The study was prematurely terminated due to poor enrollment and Part B was not conducted as per Sponsor decision. This decision was not related to any safety or efficacy findings regarding Atacicept.,3.0,,Study was terminated early as per sponsor decision due to unexpectedly slow enrollment.,f,,,,t,t,f,,,,,,,,https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html,YES,"Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website.",2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,INDUSTRY,,,,,,,2020,0.0
NCT02230189,,2014-08-28,2022-04-26,2021-01-29,2022-07-19,2014-08-29,2014-09-03,ESTIMATED,2022-07-19,2022-08-16,ACTUAL,2021-01-29,2021-02-02,ACTUAL,2022-07-19,2022-08-16,ACTUAL,2015-03,ACTUAL,2015-03-31,2022-07,2022-07-31,2020-01,ACTUAL,2020-01-31,2020-01,ACTUAL,2020-01-31,,INTERVENTIONAL,ACE,,Study of the Inflammation and Airway Changes That Occur After Exposure to Allergen in Asthmatics,Mechanistic Study of Epithelial miRNAs and T-cell Recruitment Dynamics That Occur After Allergen Challenge in Patients With Asthma.,COMPLETED,,PHASE2,28.0,ACTUAL,"University of California, San Francisco",,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,OTHER,,,,,,,2020,1.0
NCT04849377,,2021-04-14,,,2022-07-01,2021-04-14,2021-04-19,ACTUAL,,,,,,,2022-07-01,2022-07-07,ACTUAL,2022-06-14,ACTUAL,2022-06-14,2022-07,2022-07-31,2022-06-14,ACTUAL,2022-06-14,2022-06-14,ACTUAL,2022-06-14,,INTERVENTIONAL,,,RBD-HPV: Risk-Based De-Intensification for HPV+ HNSCC,RBD-HPV: Risk-Based De-Intensification for HPV+ HNSCC,WITHDRAWN,,PHASE2,0.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,4.0,,lack of eligible participants due to change in study criterias,f,,,,t,t,f,,,,,,,,,NO,"All of the individual participant data collected during the trial, after deidentification.",2024-10-15 23:41:43.345167,2024-10-15 23:41:43.345167,OTHER,,,,,,,2022,0.0
NCT06178367,,2023-12-10,,,2024-04-26,2023-12-10,2023-12-21,ACTUAL,,,,,,,2024-04-26,2024-04-30,ACTUAL,2023-08-26,ACTUAL,2023-08-26,2024-04,2024-04-30,2023-09-30,ACTUAL,2023-09-30,2023-09-30,ACTUAL,2023-09-30,,INTERVENTIONAL,,,Effectiveness and Safety of Topical Hyaluronic Acid of Different Molecular Weights in Xerotic Skin Treatment,"Effectiveness and Safety Comparison Between Moisturizers Containing Low Molecular Weight Hyaluronic Acid, High Molecular Weight Hyaluronic Acid, and Vehicle on Skin Hydration in the Elderly With Xerotic Skin",COMPLETED,,PHASE3,36.0,ACTUAL,Indonesia University,,3.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,OTHER,,,,,,,2023,1.0
NCT04446299,,2020-06-22,2023-09-29,,2023-10-25,2020-06-22,2020-06-24,ACTUAL,2023-09-29,2023-10-24,ACTUAL,,,,2023-10-25,2023-11-07,ACTUAL,2020-07-13,ACTUAL,2020-07-13,2023-10,2023-10-31,2021-01-22,ACTUAL,2021-01-22,2020-12-22,ACTUAL,2020-12-22,,INTERVENTIONAL,,,Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy,A Safety and Efficacy Comparison of BLI4900 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy,COMPLETED,,PHASE3,519.0,ACTUAL,Braintree Laboratories,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,INDUSTRY,,,,,,,2021,1.0
NCT02793583,,2016-05-23,,,2022-07-20,2016-06-03,2016-06-08,ESTIMATED,,,,,,,2022-07-20,2022-07-21,ACTUAL,2016-05-25,ACTUAL,2016-05-25,2022-07,2022-07-31,2022-07-04,ACTUAL,2022-07-04,2022-05-31,ACTUAL,2022-05-31,,INTERVENTIONAL,UNITY-NHL,,Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma,A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma,TERMINATED,,PHASE2/PHASE3,710.0,ACTUAL,"TG Therapeutics, Inc.",,3.0,,Strategic/Business Decision,f,,,,f,,,,,,,,,,,YES,Data will be shared once the last patient visit has been completed,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,INDUSTRY,,,,,,,2022,0.0
NCT04927481,,2021-05-31,,,2024-02-22,2021-06-15,2021-06-16,ACTUAL,,,,,,,2024-02-22,2024-02-23,ACTUAL,2021-06-11,ACTUAL,2021-06-11,2024-02,2024-02-29,2023-01-17,ACTUAL,2023-01-17,2023-01-17,ACTUAL,2023-01-17,,INTERVENTIONAL,,,A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced HER2 Negative Breast Cancer,"A Multicenter, Open-label, Single-arm, Phase II Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced HER2 Negative Breast Cancer",TERMINATED,,PHASE2,28.0,ACTUAL,"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.",,1.0,,The sponsor has adjusted its R\&D strategy.,f,,,,f,f,f,,,,,,,,,,,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,INDUSTRY,,,,,,,2023,0.0
NCT03496168,,2018-04-05,,,2024-01-31,2018-04-05,2018-04-12,ACTUAL,,,,,,,2024-01-31,2024-02-01,ACTUAL,2018-04-26,ACTUAL,2018-04-26,2024-01,2024-01-31,2023-11-09,ACTUAL,2023-11-09,2023-11-09,ACTUAL,2023-11-09,,INTERVENTIONAL,PIONEER-OLE,,Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER,An Open-Label Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in Study MYK-461-004 (PIONEER),COMPLETED,,PHASE2,13.0,ACTUAL,Bristol-Myers Squibb,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,INDUSTRY,,,,,,,2023,1.0
NCT04971187,,2021-07-16,2023-02-08,,2023-07-11,2021-07-16,2021-07-21,ACTUAL,2023-07-11,2023-08-01,ACTUAL,,,,2023-07-11,2023-08-01,ACTUAL,2021-06-30,ACTUAL,2021-06-30,2023-07,2023-07-31,2022-02-21,ACTUAL,2022-02-21,2022-02-21,ACTUAL,2022-02-21,,INTERVENTIONAL,,"3 participants were registered, 2 participants were not treated, not eligible or inevaluable 1 participant received treatment.",Bintrafusp Alfa With Chemotherapy for Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small Cell Lung Cancer,A Single-Arm Phase 2 Study to Investigate Bintrafusp Alfa With Platinum-Pemetrexed for TKI-Resistant EGFR-Mutant NSCLC,TERMINATED,,PHASE2,3.0,ACTUAL,M.D. Anderson Cancer Center,The study was terminated early due to the drug company no longer producing the drug.,1.0,,PI Request,,,,,t,t,f,,,,,,,,,,,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,OTHER,,,,,,,2022,0.0
NCT03387215,,2017-12-18,,,2020-12-23,2017-12-21,2018-01-02,ACTUAL,,,,,,,2020-12-23,2020-12-24,ACTUAL,2018-07-10,ACTUAL,2018-07-10,2020-12,2020-12-31,2020-03-16,ACTUAL,2020-03-16,2020-03-16,ACTUAL,2020-03-16,,INTERVENTIONAL,,,"Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure","Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of Escalating Single Doses of ITI-214 in Patients With Systolic Heart Failure",COMPLETED,,PHASE1/PHASE2,36.0,ACTUAL,"Intra-Cellular Therapies, Inc.",,4.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,INDUSTRY,,,,,,,2020,1.0
NCT04153929,,2019-11-05,2022-11-02,2022-09-05,2022-11-02,2019-11-05,2019-11-06,ACTUAL,2022-11-02,2022-11-29,ACTUAL,2022-09-05,2022-09-09,ACTUAL,2022-11-02,2022-11-29,ACTUAL,2020-04-30,ACTUAL,2020-04-30,2022-11,2022-11-30,2021-11-04,ACTUAL,2021-11-04,2021-10-08,ACTUAL,2021-10-08,,INTERVENTIONAL,,Treated set (TS): TS included all patients who were randomized and received at least one dose of study drug.,A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.,"A Phase II, Randomized, Parallel Group, Dose-finding Study of Subcutaneously Administered BI 456906 for 16 Weeks, Compared With Placebo and Open-label Semaglutide in Patients With Type 2 Diabetes Mellitus.",COMPLETED,,PHASE2,413.0,ACTUAL,Boehringer Ingelheim,,8.0,,,f,,,,f,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.",2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,INDUSTRY,,,,,,,2021,1.0
NCT06017479,,2023-08-24,2024-04-23,,2024-10-02,2023-08-24,2023-08-30,ACTUAL,2024-10-02,2024-10-09,ACTUAL,,,,2024-10-02,2024-10-09,ACTUAL,2022-12-30,ACTUAL,2022-12-30,2024-10,2024-10-31,2024-03-25,ACTUAL,2024-03-25,2024-03-25,ACTUAL,2024-03-25,,INTERVENTIONAL,,"Besides the required samples are 126 samples to complete the study. There are 59 samples that didn't meet the inclusion criteria of the study, which are because of there are 8 samples who refuse to participate, 14 samples that are under 18 years old, 7 samples that have history of antibiotics consumption in 1 month prior to the study, 19 samples that are UTI proved through urinalysis, 11 samples that use of urinary catheter prior to the study.",Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic for UTI Prevention,Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic Prophylaxis for Urinary Tract Infection Prevention in Post-Urodynamic Examination,COMPLETED,,PHASE1/PHASE2,126.0,ACTUAL,Indonesia University,The limitation of the study is that many of the patients with UTIs refuse to undergo urine culture tests due to several reasons.,2.0,,,f,,,,f,f,f,,,,,,Immediately following publication. No end date,Anyone who wishes to access the data,,YES,These are the study protocol used in this study,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,OTHER,,,,,,,2024,1.0
NCT03751969,,2018-11-18,,,2022-05-27,2018-11-21,2018-11-23,ACTUAL,,,,,,,2022-05-27,2022-06-02,ACTUAL,2020-03-30,ACTUAL,2020-03-30,2022-05,2022-05-31,2020-12-01,ACTUAL,2020-12-01,2020-11-01,ACTUAL,2020-11-01,,INTERVENTIONAL,,,A Study Evaluating the Mass Balance of Micro-dose[14C]HSK3486 Emulsion Injection in Healthy Adults,A Study Evaluating the Mass Balance of Micro-dose [14C]HSK3486 Emulsion Injection in Healthy Chinese Male Adults,WITHDRAWN,,PHASE1,0.0,ACTUAL,"Haisco Pharmaceutical Group Co., Ltd.",,1.0,,study canceled,f,,,,,f,f,,,,,,,,,,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,INDUSTRY,,,,,,,2020,0.0
NCT04445688,,2020-06-19,2023-07-19,2021-05-26,2023-09-08,2020-06-22,2020-06-24,ACTUAL,2023-08-15,2023-08-21,ACTUAL,,2023-08-21,ACTUAL,2023-09-08,2023-09-14,ACTUAL,2020-07-15,ACTUAL,2020-07-15,2023-09,2023-09-30,2020-12-01,ACTUAL,2020-12-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,,,Crossover Trial of AD036 in Obstructive Sleep Apnea,"Phase 2, Randomized, 3-Period, Placebo-Controlled Crossover Study to Evaluate the Efficacy and Safety in Obstructive Sleep Apnea of AD036 Versus Placebo or Atomoxetine",COMPLETED,,PHASE2,62.0,ACTUAL,Apnimed,,3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,INDUSTRY,,,,,,,2020,1.0
NCT02656888,,2016-01-12,,,2019-10-14,2016-01-13,2016-01-15,ESTIMATED,,,,,,,2019-10-14,2019-10-16,ACTUAL,2019-06,ESTIMATED,2019-06-30,2019-10,2019-10-31,2020-09,ESTIMATED,2020-09-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children,"Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children",WITHDRAWN,,PHASE3,0.0,ACTUAL,EMS,,2.0,,Sponsor decision,f,,,,t,f,f,,,,,,,,,,,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,INDUSTRY,,,,,,,2020,0.0
NCT04005352,,2019-07-01,2023-08-31,,2024-10-07,2019-07-01,2019-07-02,ACTUAL,2024-01-03,2024-01-30,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2019-09-25,ACTUAL,2019-09-25,2024-10,2024-10-31,2022-09-09,ACTUAL,2022-09-09,2022-09-09,ACTUAL,2022-09-09,,INTERVENTIONAL,TALON,,Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON),"A 64-week, Two-arm, Randomized, Double-masked, Multicenter, Phase IIIb Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen in Patients With Neovascular Agerelated Macular Degeneration (TALON)",COMPLETED,,PHASE3,734.0,ACTUAL,Novartis,,2.0,,,,,,,f,t,f,,,,,,,,https://clinicalstudydatarequest.com/,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,INDUSTRY,,,,,,,2022,1.0
NCT04289558,,2020-02-27,,,2021-03-12,2020-02-27,2020-02-28,ACTUAL,,,,,,,2021-03-12,2021-03-16,ACTUAL,2021-06-01,ESTIMATED,2021-06-01,2021-01,2021-01-31,2021-10-01,ESTIMATED,2021-10-01,2021-10-01,ESTIMATED,2021-10-01,,INTERVENTIONAL,,,Nitrite Infusion in Children With Malaria,"Safety, Feasibility, and Endothelial Effects of Sodium Nitrite Infusion in Children With Falciparum Malaria",WITHDRAWN,,PHASE1,0.0,ACTUAL,Duke University,,1.0,,"current grant expiration in May, insufficient funds remaining, travel restrictions, COVID-19 restrictions in Tanzania, etc.",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,OTHER,,,,,,,2021,0.0
NCT03787095,,2018-12-21,2021-08-19,,2022-02-25,2018-12-21,2018-12-26,ACTUAL,2021-11-11,2021-12-09,ACTUAL,,,,2022-02-25,2022-03-02,ACTUAL,2019-08-13,ACTUAL,2019-08-13,2022-02,2022-02-28,2020-08-18,ACTUAL,2020-08-18,2020-08-18,ACTUAL,2020-08-18,,INTERVENTIONAL,,All participants,Safety and Immunotherapeutic Activity of an Anti-PD-1 Antibody (Cemiplimab) in Participants With HIV-1 on Suppressive cART,"Safety and Immunotherapeutic Activity of an Anti-PD-1 Antibody (Cemiplimab) in Participants With HIV-1 on Suppressive cART: A Phase I/II, Double-blind, Placebo-controlled, Ascending Multiple Dose Study",TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),The study was terminated early due to adverse events and was not able to fully evaluate the efficacy outcomes due to the small number of accrued participants.,2.0,,Stopped by monitoring committee recommendation due to adverse events,f,,,,t,t,f,,,,,,Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.,* With whom?~  * Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses?~  * To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism will data be made available?~  * Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at:https://submit.mis.s-3.net/ Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.,https://submit.mis.s-3.net/,YES,"Individual participant data that underlie results in the publication, after deidentification.",2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,NIH,,,,,,,2020,0.0
NCT06181227,,2023-11-28,,,2024-04-23,2023-12-12,2023-12-26,ACTUAL,,,,,,,2024-04-23,2024-04-24,ACTUAL,2023-11-30,ACTUAL,2023-11-30,2023-12,2023-12-31,2024-04-05,ACTUAL,2024-04-05,2024-04-05,ACTUAL,2024-04-05,,INTERVENTIONAL,,,A Phase 2 Study of Intravitreal AVD-104 in Diabetic Macular Edema,A Phase 2 Study to Evaluate the Safety and Treatment Effect of Intravitreal AVD-104 in Participants With Diabetic Macular Edema,TERMINATED,,PHASE2,21.0,ACTUAL,"Aviceda Therapeutics, Inc.",,2.0,,Lack of Efficacy,f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,INDUSTRY,,,,,,,2024,0.0
NCT03706040,,2018-10-11,2021-10-20,,2021-10-20,2018-10-11,2018-10-15,ACTUAL,2021-10-20,2021-11-18,ACTUAL,,,,2021-10-20,2021-11-18,ACTUAL,2018-12-27,ACTUAL,2018-12-27,2021-10,2021-10-31,2021-04-26,ACTUAL,2021-04-26,2020-10-28,ACTUAL,2020-10-28,,INTERVENTIONAL,,The intent-to-treat population includes all randomized participants,A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis,"A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult and Adolescent Subjects With Moderate to Severe Atopic Dermatitis",COMPLETED,,PHASE2,172.0,ACTUAL,AbbVie,,3.0,,,f,,,,t,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,INDUSTRY,,,,,,,2021,1.0
NCT04348071,,2020-04-13,,,2021-03-03,2020-04-13,2020-04-15,ACTUAL,,,,,,,2021-03-03,2021-03-08,ACTUAL,2021-07,ESTIMATED,2021-07-31,2021-03,2021-03-31,2021-10,ESTIMATED,2021-10-31,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,,,Safety and Efficacy of Ruxolitinib for COVID-19,Safety and Efficacy of Ruxolitinib for COVID-19,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,"University of Colorado, Denver",,1.0,,Could not make FDA required changes,f,,,,,t,f,,,f,,,Data will be made available upon publication in a peer-reviewed journal.,Data access requests will be reviewed by the sponsor-investigator and collaborators.,,YES,De-identified individual participant data will be made available for all primary outcome measures.,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,OTHER,,,,,,,2021,0.0
NCT04409483,,2020-05-28,,,2021-02-09,2020-05-28,2020-06-01,ACTUAL,,,,,,,2021-02-09,2021-02-10,ACTUAL,2020-06-01,ACTUAL,2020-06-01,2021-02,2021-02-28,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,TRASCOV,,Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger,Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger,WITHDRAWN,,PHASE3,0.0,ACTUAL,Epicentre,,2.0,,Epidemic dynamics,f,,,,t,f,f,,,,,,Data will become fully accessible after primary publication of results.,,,YES,De-identified patient data will be shared with local and international authorities.,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,OTHER,,,,,,,2020,0.0
NCT04428333,,2020-06-09,2022-04-27,,2024-09-17,2020-06-09,2020-06-11,ACTUAL,2022-04-27,2022-05-25,ACTUAL,,,,2024-09-17,2024-10-09,ACTUAL,2020-08-12,ACTUAL,2020-08-12,2024-09,2024-09-30,2023-09-19,ACTUAL,2023-09-19,2021-04-27,ACTUAL,2021-04-27,,INTERVENTIONAL,INDUCE-4,,Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma,"A Randomized, Double-Blind, Adaptive, Phase II/III Study of GSK3359609 in Combination With Pembrolizumab and 5FU-Platinum Chemotherapy Versus Placebo in Combination With Pembrolizumab Plus 5FU-Platinum Chemotherapy for First-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma",TERMINATED,,PHASE3,117.0,ACTUAL,GlaxoSmithKline,,2.0,,The trial was stopped by the sponsor based on assessment of the clinical data,f,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,INDUSTRY,,,,,,,2023,0.0
NCT04393441,,2020-05-14,2024-05-31,2022-06-01,2024-05-31,2020-05-14,2020-05-19,ACTUAL,2024-05-31,2024-06-26,ACTUAL,2022-06-01,2022-06-06,ACTUAL,2024-05-31,2024-06-26,ACTUAL,2020-06-29,ACTUAL,2020-06-29,2024-05,2024-05-31,2021-06-15,ACTUAL,2021-06-15,2021-06-15,ACTUAL,2021-06-15,,INTERVENTIONAL,,Intend to treat (ITT) population consisted of all randomized participants.,Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease,"A Multicenter, Single-masked, Randomized Study to Compare the Efficacy and Safety of a New Artificial Tear Formulation (011516X) With Systane® Ultra Multidose for 90 Days in Participants With Dry Eye Disease",COMPLETED,,PHASE3,400.0,ACTUAL,Allergan,,2.0,,,f,,,,f,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,INDUSTRY,,,,,,,2021,1.0
NCT02901548,,2016-09-12,2021-05-13,,2022-07-27,2016-09-12,2016-09-15,ESTIMATED,2021-05-17,2021-06-11,ACTUAL,,,,2022-07-27,2022-07-29,ACTUAL,2017-02-16,ACTUAL,2017-02-16,2022-07,2022-07-31,2021-09-07,ACTUAL,2021-09-07,2020-07-24,ACTUAL,2020-07-24,,INTERVENTIONAL,,,Phase 2 Durvalumab (Medi4736) for Bacillus Calmette-Guérin (BCG) Refactory Urothelial Carcinoma in Situ of the Bladder,"A Phase 2 Study of Check Point Inhibitor, Durvalumab (Medi4736) for Bacillus Calmette-Guérin (BCG) Refractory Urothelial Carcinoma in Situ (CIS) of the Bladder",TERMINATED,,PHASE2,17.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,All reported deaths were on post study treatment survival follow up.,1.0,,Study closed early due to futility,f,,,,f,t,f,,,,,,,,,,,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,OTHER,,,,,,,2021,0.0
NCT03378297,,2017-10-31,,,2024-05-08,2017-12-18,2017-12-19,ACTUAL,,,,,,,2024-05-08,2024-05-10,ACTUAL,2018-05-04,ACTUAL,2018-05-04,2024-05,2024-05-31,2023-01-05,ACTUAL,2023-01-05,2023-01-05,ACTUAL,2023-01-05,,INTERVENTIONAL,IMPACT,,IMPACT: A Randomized WOO Study of Novel Therapeutic Agents in Women Triaged to Primary Surgery for EOC,IMPACT: A Phase 0 Randomized Window-of-Opportunity Study of Novel and Repurposed Therapeutic Agents in Women Triaged to Primary Surgery for Advanced Epithelial Ovarian Cancer in Stages IIIa - IV.,COMPLETED,,EARLY_PHASE1,26.0,ACTUAL,Haukeland University Hospital,,5.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 23:41:43.345167,2024-10-15 23:41:43.345167,OTHER,,,,,,,2023,1.0
NCT02954458,,2016-11-02,2021-08-03,,2021-09-16,2016-11-02,2016-11-03,ESTIMATED,2021-09-16,2021-10-13,ACTUAL,,,,2021-09-16,2021-10-13,ACTUAL,2017-01-09,ACTUAL,2017-01-09,2021-08,2021-08-31,2020-11-05,ACTUAL,2020-11-05,2020-11-05,ACTUAL,2020-11-05,,INTERVENTIONAL,,The safety population consisted of enrolled participants who provided informed consent and met all the inclusion criteria.,Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS),"A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Patients With Short Bowel Syndrome Who Completed TED-C14-006 or SHP633-301",COMPLETED,,PHASE3,61.0,ACTUAL,Takeda,,1.0,,,f,,,,t,t,t,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,INDUSTRY,,,,,,,2020,1.0
NCT02069431,,2014-02-10,,,2020-06-17,2014-02-19,2014-02-24,ESTIMATED,,,,,,,2020-06-17,2020-06-19,ACTUAL,2016-02,,2016-02-29,2020-06,2020-06-30,2020-05,ACTUAL,2020-05-31,2020-05,ACTUAL,2020-05-31,,INTERVENTIONAL,,,Oxytocin Aging Study,Effects of Oxytocin on Physical and Cognitive Functioning in the Elders,TERMINATED,,PHASE1,153.0,ACTUAL,University of Florida,,2.0,,"This study was halted prematurely due to the COVID-19 pandemic, resulting in the inability to enroll participants. Funding for this project has also ended.",f,,,,f,t,f,,,,,,,,,,,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,OTHER,,,,,,,2020,0.0
NCT05083949,,2021-10-06,2022-09-06,,2022-09-06,2021-10-06,2021-10-19,ACTUAL,2022-09-06,2023-07-27,ACTUAL,,,,2022-09-06,2023-07-27,ACTUAL,2021-07-23,ACTUAL,2021-07-23,2022-09,2022-09-30,2021-09-09,ACTUAL,2021-09-09,2021-08-06,ACTUAL,2021-08-06,,INTERVENTIONAL,InPedILD®,Treated Set (TS): The treated set included all participants in the research that were randomized and treated with at least one dose of study medication.,A Study in Healthy Humans to Assess the Relative Bioavailability of One Fixed-dose Combination Tablet Empagliflozin/Metformin Versus Jardiance® Tablet and Glifage® Tablet Administered Together,"Relative Bioavailability of Empagliflozin/Metformin Fixed-dose Combination - Empagliflozin 12.5 mg + Metformin 850mg (Boehringer Ingelheim) Coated Tablet Versus Jardiance® 10mg (Reference 1: Boehringer Ingelheim) Coated Tablet and Glifage® 850mg (Reference 2: Merck S / A. ) Coated Tablet, Administered Together in Healthy Male and Female Subjects Under Fed Conditions: an Open-label, Randomised, Single-dose, Two-way Crossover Study",COMPLETED,,PHASE1,32.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to:https://www.mystudywindow.com/msw/datasharing",2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,INDUSTRY,,,,,,,2021,1.0
NCT01265017,,2010-12-20,,,2018-04-16,2010-12-21,2010-12-22,ESTIMATED,,,,,,,2018-04-16,2018-04-18,ACTUAL,2012-07,,2012-07-31,2018-04,2018-04-30,2020-06,ESTIMATED,2020-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,Role of Pregnancy Related Hormones in Lowering the Insulin Requirement in Pregnant Women With Type 1 Diabetes,"Single-center, Double-masked, Placebo-controlled Parallel-group Study of Pregnancy-related Hormones Estradiol and Medroxyprogesterone, in Conjunction With Hydrocortisone and Growth Hormone to Stimulate C-peptide Secretion in Women With T1DM",WITHDRAWN,,PHASE1,0.0,ACTUAL,Sansum Diabetes Research Institute,,2.0,,Insufficient funding,f,,,,f,,,,,,,,,,,,,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,OTHER,,,,,,,2020,0.0
NCT03790072,,2018-12-12,,,2021-03-29,2018-12-27,2018-12-31,ACTUAL,,,,,,,2021-03-29,2021-03-30,ACTUAL,2018-11-27,ACTUAL,2018-11-27,2021-03,2021-03-31,2021-03-26,ACTUAL,2021-03-26,2021-03-26,ACTUAL,2021-03-26,,INTERVENTIONAL,,,Ex-vivo Expanded γδ T-lymphocytes (OmnImmune®) in Patients With Acute Myeloid Leukaemia (AML),"Safety and Efficacy of Ex-vivo Expanded Allogeneic γδ T-lymphocytes (OmnImmune®) in Patients With Active Relapsed or Refractory Acute Myeloid Leukaemia (AML) Who Are Not Eligible for or do Not Consent to High Dose Salvage Chemotherapy and/or Allogeneic Haematopoietic Cell Transplantation (HCT). A Dose Escalation, Open-label, Phase I Study",COMPLETED,,PHASE1,10.0,ACTUAL,TC Biopharm,,1.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,INDUSTRY,,,,,,,2021,1.0
NCT04581785,,2020-10-02,2024-01-05,,2024-02-21,2020-10-07,2020-10-09,ACTUAL,2024-02-21,2024-02-23,ACTUAL,,,,2024-02-21,2024-02-23,ACTUAL,2021-05-29,ACTUAL,2021-05-29,2024-02,2024-02-29,2023-01-10,ACTUAL,2023-01-10,2023-01-10,ACTUAL,2023-01-10,,INTERVENTIONAL,SUNRISE,The safety population included all participants who received at least 1 dose of study drug. Cohorts have been combined in the Baseline Characteristics section to maintain participant confidentiality.,Gene Therapy With hLB-001 in Pediatric Patients With Severe Methylmalonic Acidemia,A Phase 1/2 Open-label Clinical Study of hLB-001 Gene Therapy in Pediatric Patients With Methylmalonic Acidemia Characterized by MMUT Mutations,TERMINATED,,PHASE1/PHASE2,4.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",The study was terminated early due to low likelihood of clinical benefit in treated participants. Hence; no participants were enrolled in Part C and thus Cohort 2 was not initiated.,5.0,,Due to low likelihood of clinical benefit in treated participants.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,INDUSTRY,,,,,,,2023,0.0
NCT03856359,,2019-01-31,2021-11-18,,2021-11-18,2019-02-25,2019-02-27,ACTUAL,2021-11-18,2021-12-17,ACTUAL,,,,2021-11-18,2021-12-17,ACTUAL,2019-04-09,ACTUAL,2019-04-09,2021-11,2021-11-30,2020-11-19,ACTUAL,2020-11-19,2020-11-19,ACTUAL,2020-11-19,,INTERVENTIONAL,,,Trial of Rifaximin in Probable Alzheimer's Disease,"Pilot, Single Center, Open, Trial of Rifaximin in Probable Alzheimer's Disease",COMPLETED,,PHASE2,10.0,ACTUAL,Duke University,,1.0,,,f,,,,,t,f,,,t,,,,,,NO,,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,OTHER,,,,,,,2020,1.0
NCT04067492,,2019-08-05,2022-03-23,,2022-03-23,2019-08-22,2019-08-26,ACTUAL,2022-03-23,2022-07-25,ACTUAL,,,,2022-03-23,2022-07-25,ACTUAL,2018-03-26,ACTUAL,2018-03-26,2022-03,2022-03-31,2020-05-12,ACTUAL,2020-05-12,2020-03-16,ACTUAL,2020-03-16,,INTERVENTIONAL,,,"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Evaluation of RPH-104 Administered at Different Doses to Patients With Acute Gout Attack","An Open-label, Single-dose, Active-controlled Randomized Phase IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RPH-104 (RPH-104/L04018) Administered at Different Doses to Patients With Acute Gout Attack",TERMINATED,,PHASE2,47.0,ACTUAL,R-Pharm,,6.0,,"In view of the continuing insufficient patient recruitment in the study due to the difficult epidemiological situation and the need for rational allocation of company resources, as well as based on the results of the interim analysis.",f,,,,f,f,f,,,,,,,,,,,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,INDUSTRY,,,,,,,2020,0.0
NCT04918147,,2021-06-04,,,2024-01-09,2021-06-04,2021-06-08,ACTUAL,,,,,,,2024-01-09,2024-01-11,ACTUAL,2021-10-13,ACTUAL,2021-10-13,2024-01,2024-01-31,2024-01-04,ACTUAL,2024-01-04,2024-01-04,ACTUAL,2024-01-04,,INTERVENTIONAL,,,Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD),Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD),TERMINATED,,PHASE2,8.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,4.0,,The study was terminated early based on disease flare/lack of efficacy in the early phase of the trial.,f,,,,t,t,f,,,,,,"On average, within 24 months after database lock for the trial.",Open access.,https://www.immport.org/home,YES,"The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.",2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,NIH,,,,,,,2024,0.0
NCT04498468,,2020-07-28,2024-01-16,,2024-03-13,2020-08-03,2020-08-04,ACTUAL,2024-03-13,2024-03-15,ACTUAL,,,,2024-03-13,2024-03-15,ACTUAL,2021-03-16,ACTUAL,2021-03-16,2024-03,2024-03-31,2023-03-03,ACTUAL,2023-03-03,2023-03-03,ACTUAL,2023-03-03,,INTERVENTIONAL,,Only 75 (150 eyes) patients' data were analyzed at baseline as 2 patients were lost to follow-up before week 4.,Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye,Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye,TERMINATED,,PHASE4,77.0,ACTUAL,Johns Hopkins University,"The study was not able to enroll its planned sample size. VAS, while consistently used in measuring clinical symptoms of illnesses, is limited in that patients may encounter difficulties in rating their symptomology, especially if the participants feel ambivalent towards the VAS prompts.",2.0,,"The study was terminated prematurely due to administrative reasons; loss of several research personnel. Because of strict eligibility criteria, the investigators anticipated delays in completing enrollment and therefore decided to terminate early.",f,,,,f,t,f,,,f,,,,,,NO,Aggregated information only will be shared with sponsor,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,OTHER,,,,,eyes,,2023,0.0
NCT03767439,,2018-12-05,,,2019-12-16,2018-12-05,2018-12-06,ACTUAL,,,,,,,2019-12-16,2019-12-18,ACTUAL,2019-07,ESTIMATED,2019-07-31,2019-12,2019-12-31,2020-02,ESTIMATED,2020-02-29,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,Nivolumab With Vismodegib in Patients With Basal Cell Nevus Syndrome,Trial of Nivolumab With Vismodegib in Patients With Basal Cell Nevus Syndrome (BCNS),WITHDRAWN,,PHASE2,0.0,ACTUAL,Columbia University,,1.0,,Loss of funding,f,,,,t,t,f,,,f,,,,,,,,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,OTHER,,,,,,,2020,0.0
NCT01345578,,2011-04-26,,,2022-12-05,2011-04-28,2011-05-02,ESTIMATED,,,,,,,2022-12-05,2022-12-07,ACTUAL,2011-03,,2011-03-31,2022-12,2022-12-31,2022-03-31,ACTUAL,2022-03-31,2022-03-31,ACTUAL,2022-03-31,,INTERVENTIONAL,,,Hepatocyte Transplantation for Liver Based Metabolic Disorders,Hepatocyte Transplantation for Liver Based Metabolic Disorders,TERMINATED,,PHASE1,5.0,ACTUAL,University of Pittsburgh,,1.0,,seeking additional funding,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,OTHER,,,,,,,2022,0.0
NCT03058094,,2016-12-01,,,2019-01-31,2017-02-15,2017-02-20,ACTUAL,,,,,,,2019-01-31,2019-02-04,ACTUAL,2018-12,ESTIMATED,2018-12-31,2019-01,2019-01-31,2020-01,ESTIMATED,2020-01-31,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,A Study Comparing AC0010 and Chemotherapy in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI,"A Phase III, Open-Label, Randomized Multicenter Study to Compare AC0010 and Pemetrexed/Cisplatin in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Hangzhou ACEA Pharmaceutical Research Co., Ltd.",,2.0,,Considiering to change the Chemotherapy into Gefitinib,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,INDUSTRY,,,,,,,2020,0.0
NCT03490760,,2018-03-14,2023-08-22,,2023-09-20,2018-04-05,2018-04-06,ACTUAL,2023-09-20,2023-10-12,ACTUAL,,,,2023-09-20,2023-10-12,ACTUAL,2018-11-09,ACTUAL,2018-11-09,2023-09,2023-09-30,2020-07-09,ACTUAL,2020-07-09,2020-07-09,ACTUAL,2020-07-09,,INTERVENTIONAL,,,Durvalumab and Booster Radiation in Metastatic Adenocarcinoma of the Pancreas,Phase II Trial of In Situ Tumor Vaccination Using Durvalumab and Booster Radiation Therapy in Patients With Metastatic Adenocarcinoma of the Pancreas Who Have Progressed Through First-line Chemotherapy,TERMINATED,,PHASE2,9.0,ACTUAL,Baptist Health South Florida,This study was terminated early because of poor enrollment and participants being withdrawn soon after enrollment due to disease progression. Statistical analysis was not possible with the small number of evaluable participants.,1.0,,Slow/poor enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,OTHER,,,,,,,2020,0.0
NCT03212352,,2017-07-02,,,2020-04-29,2017-07-06,2017-07-11,ACTUAL,,,,,,,2020-04-29,2020-05-01,ACTUAL,2018-06-27,ACTUAL,2018-06-27,2019-09,2019-09-30,2020-03-16,ACTUAL,2020-03-16,2020-01-23,ACTUAL,2020-01-23,,INTERVENTIONAL,Triple M,,Comparing Two Medical Treatments for Early Pregnancy Failure.,Mifepristone and Misoprostol Versus Misoprostol Alone for Uterine Evacuation After Early Pregnancy Failure: a Randomized Double Blind Placebo-controlled Comparison (Triple M Trial),TERMINATED,,PHASE4,342.0,ACTUAL,Radboud University Medical Center,,2.0,,"Advised by DSMB based on interim-analysis, highly significant difference.",f,,,,t,f,f,,,f,,,,,,NO,,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,OTHER,,,,,,,2020,0.0
NCT04143581,,2019-10-25,,,2021-09-06,2019-10-28,2019-10-29,ACTUAL,,,,,,,2021-09-06,2021-09-13,ACTUAL,2021-09-03,ACTUAL,2021-09-03,2021-09,2021-09-30,2021-09-03,ACTUAL,2021-09-03,2021-09-03,ACTUAL,2021-09-03,,INTERVENTIONAL,EMPATHY,,SGLT2 Inhibitors in Glomerular Hyperfiltration,Evaluating the Short-Term Renal and Systemic Effects of SGLT2 Inhibition in Non-Diabetic Patients at Risk of Accelerated GFR Decline Because of Glomerular Hyperfiltration: a Sequential OFF-ON-OFF Study With One-Month Empagliflozin Therapy Followed by One-Month Recovery Period,WITHDRAWN,,PHASE2,0.0,ACTUAL,Mario Negri Institute for Pharmacological Research,,1.0,,Lack of funds,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,OTHER,,,,,,,2021,0.0
NCT04032717,,2019-04-02,,,2023-07-05,2019-07-19,2019-07-25,ACTUAL,,,,,,,2023-07-05,2023-07-06,ACTUAL,2019-07-10,ACTUAL,2019-07-10,2023-07,2023-07-31,2021-02-04,ACTUAL,2021-02-04,2021-02-04,ACTUAL,2021-02-04,,INTERVENTIONAL,PREVENT,,Griffithsin-based Rectal Microbicide for PREvention of Viral ENTry (PREVENT),"A Randomized, Double-Blind Phase 1 Safety and Pharmacokinetic Study of Q-Griffithsin Enema Administered Rectally to HIV-1 Seronegative Adults",TERMINATED,,PHASE1,18.0,ACTUAL,University of Pittsburgh,,3.0,,"Due to the COVID-19 pandemic, study enrollment has been prematurely terminated.",f,,,,t,t,f,,,,,,Upon publication,,,YES,"The awardee institution will follow Federal grant policies concerning the sharing of research data. The awardee institution will share its information, data and resources among its own researchers and the collaborating researchers as well as with researchers at other institutions. The research team will make the results of this collaboration and any accompanying data available to the public. In accordance with Federal policies on Data Sharing, research data will be made available to researchers and/or the general public as requested. The limitations on this policy are that data will not generally be available until such a time that it is submitted for publication. Also, all human subjects' rights to privacy with respect to any human tissue samples to be used as a part of this study will be approved by the appropriate regulatory boards, protected and de-identified.",2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,OTHER,,,,,,,2021,0.0
NCT01711658,,2012-10-16,2021-10-29,,2023-10-04,2012-10-18,2012-10-22,ESTIMATED,2021-10-29,2021-11-29,ACTUAL,,,,2023-10-04,2023-10-17,ACTUAL,2013-03-15,ACTUAL,2013-03-15,2021-10,2021-10-31,2022-09-21,ACTUAL,2022-09-21,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,TRYHARD,All randomized patients,TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.,"TRYHARD: A Phase II, Randomized, Double Blind, Placebo-Controlled Study of Lapatinib (Tykerb®) for Non-HPV Locally Advanced Head and Neck Cancer With Concurrent Chemoradiation",COMPLETED,,PHASE2,142.0,ACTUAL,Radiation Therapy Oncology Group,"A total of 69 progression-free survival (PFS) were required. As of September 13, 2020, the number of observed PFS events was 66. At the Radiation Therapy Oncology Group Foundation Data Monitoring Committee meeting on October 22, 2020, a decision was made to report the final results using data through November 30, 2020. This decision has a minor impact (\<1%) on the power given that 67 PFS events are included in the final analysis of this trial.",2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,NETWORK,,,,,,,2022,1.0
NCT03265288,,2017-02-21,2024-08-01,,2024-10-04,2017-08-25,2017-08-29,ACTUAL,2024-10-04,2024-10-09,ACTUAL,,,,2024-10-04,2024-10-09,ACTUAL,2018-11-05,ACTUAL,2018-11-05,2024-10,2024-10-31,2021-09-15,ACTUAL,2021-09-15,2021-09-15,ACTUAL,2021-09-15,,INTERVENTIONAL,APPLAUD,,Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults,"APPLAUD: A Double-Blind, Randomized, Placebo-Controlled, Phase II Study of the Efficacy and Safety of LAU-7b in the Treatment of Cystic Fibrosis in Adults",COMPLETED,,PHASE2,166.0,ACTUAL,Laurent Pharmaceuticals Inc.,"The APPLAUD study started enrollment in November 2018 and was conducted through the COVID-19 pandemic and during market introduction of ETI (elexacaftor/tezacaftor/ivacaftor) in the participating countries. However, the study protocol and the statistical plan were amended to address the higher dropout rates caused by these two factors during the clinical trial and to allow enrolment of patients stabilized on ETI as their background CFTR modulator therapy.",2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,INDUSTRY,,,,,,,2021,1.0
NCT03148795,,2017-05-09,2021-08-11,,2024-03-07,2017-05-09,2017-05-11,ACTUAL,2021-08-11,2021-09-08,ACTUAL,,,,2024-03-07,2024-04-05,ACTUAL,2017-07-04,ACTUAL,2017-07-04,2024-03,2024-03-31,2023-03-31,ACTUAL,2023-03-31,2020-09-04,ACTUAL,2020-09-04,,INTERVENTIONAL,,Safety population included all participants who received at least 1 dose of talazoparib including participants enrolled prior to protocol amendment 3 with non-measurable disease and with deoxyribonucleic acid damage response (DDR) deficiencies which was likely or might sensitized the tumor to poly adenosine diphosphate-ribose polymerase (PARP) inhibition as assessed using an expanded DDR gene panel.,A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer,"TALAPRO-1: A PHASE 2, OPEN-LABEL, RESPONSE RATE STUDY OF TALAZOPARIB IN MEN WITH DNA REPAIR DEFECTS AND METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO PREVIOUSLY RECEIVED TAXANE-BASED CHEMOTHERAPY AND PROGRESSED ON AT LEAST 1 NOVEL HORMONAL AGENT (ENZALUTAMIDE AND/OR ABIRATERONE ACETATE/PREDNISONE)",COMPLETED,,PHASE2,128.0,ACTUAL,Pfizer,,1.0,,,f,,,,,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,INDUSTRY,,,,,,,2023,1.0
NCT04893018,,2021-05-14,2024-04-01,,2024-06-03,2021-05-14,2021-05-19,ACTUAL,2024-06-03,2024-06-27,ACTUAL,,,,2024-06-03,2024-06-27,ACTUAL,2022-05-23,ACTUAL,2022-05-23,2024-04,2024-04-30,2023-12-15,ACTUAL,2023-12-15,2023-12-15,ACTUAL,2023-12-15,,INTERVENTIONAL,,Population included all enrolled participants.,NT-I7 for Kaposi Sarcoma in Patients With or Without HIV,Phase 1 Study of NT-I7 (rhIL-7-hyFc) for the Treatment of Kaposi Sarcoma in Patients With or Without Infection With HIV,TERMINATED,,PHASE1,8.0,ACTUAL,Fred Hutchinson Cancer Center,Enrollment for this study was terminated early due end of funding. Some of the planned statistical analyses were not performed.,1.0,,Terminated due to end of funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,OTHER,,,,,,,2023,0.0
NCT04350450,,2020-04-14,,,2020-05-22,2020-04-14,2020-04-17,ACTUAL,,,,,,,2020-05-22,2020-05-27,ACTUAL,2020-04,ESTIMATED,2020-04-30,2020-04,2020-04-30,2020-08,ESTIMATED,2020-08-31,2020-08,ESTIMATED,2020-08-31,,INTERVENTIONAL,,,Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore,"Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore: a Review of Process Feasibility, Safety, and Clinical Outcomes",WITHDRAWN,,PHASE2,0.0,ACTUAL,Montefiore Medical Center,,2.0,,PI withdrew the submission to the IRB,f,,,,,t,f,,,t,,,,,,NO,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,OTHER,,,,,,,2020,0.0
NCT04377503,,2020-05-02,,,2022-03-14,2020-05-04,2020-05-06,ACTUAL,,,,,,,2022-03-14,2022-03-29,ACTUAL,2020-05-01,ACTUAL,2020-05-01,2020-05,2020-05-31,2020-11-30,ACTUAL,2020-11-30,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,,,Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19,Comparison of the Efficacy and Safety of Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19. A Prospective Randomized Controlled Phase II Trial,TERMINATED,,PHASE2,30.0,ACTUAL,Hospital Sao Domingos,,2.0,,The number of critically ill patients wirh COVID-19 decrease abruptly,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,OTHER,,,,,,,2020,0.0
NCT05156905,,2021-12-01,,,2024-10-05,2021-12-01,2021-12-14,ACTUAL,,,,,,,2024-10-05,2024-10-09,ACTUAL,2022-06-16,ACTUAL,2022-06-16,2024-10,2024-10-31,2024-10-01,ACTUAL,2024-10-01,2024-10-01,ACTUAL,2024-10-01,,INTERVENTIONAL,,,Study of Docetaxel Combined with Cirmtuzumab in Metastatic Castration Resistant Prostate Cancer,A Phase 1b Trial Investigating Docetaxel Combined with Cirmtuzumab in Patients with Metastatic Castration Resistant Prostate Cancer,TERMINATED,,PHASE1,6.0,ACTUAL,"University of California, San Diego",,1.0,,Oncternal closing clinical trial operations.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,OTHER,,,,,,,2024,0.0
NCT03249792,,2017-08-09,2024-02-05,,2024-02-05,2017-08-11,2017-08-15,ACTUAL,2024-02-05,2024-07-24,ACTUAL,,,,2024-02-05,2024-07-24,ACTUAL,2017-09-20,ACTUAL,2017-09-20,2024-01,2024-01-31,2023-02-22,ACTUAL,2023-02-22,2023-02-22,ACTUAL,2023-02-22,,INTERVENTIONAL,,"Baseline characteristics were analyzed in all participants allocated to Arms 1, 2, and 4. Arm 3 did not enroll any participants. Per protocol, baseline characteristics were not analyzed separately for the switch over period.",Study of MK-2118 Administered as Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab (MK-3475) or by Subcutaneous Injection in Combination With Pembrolizumab in the Treatment of Adults With Advanced/Metastatic Solid Tumors or Lymphomas (MK-2118-001),"A Phase 1 Open-label, Multicenter Study of MK-2118 Administered by Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab or by Subcutaneous Injection in Combination With Pembrolizumab for Patients With Advanced/Metastatic Solid Tumors or Lymphomas",TERMINATED,,PHASE1,140.0,ACTUAL,Merck Sharp & Dohme LLC,,25.0,,Business Reasons,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,INDUSTRY,,,,,,,2023,0.0
NCT03472872,,2018-02-26,,,2024-05-23,2018-03-14,2018-03-21,ACTUAL,,,,,,,2024-05-23,2024-05-24,ACTUAL,2017-09-05,ACTUAL,2017-09-05,2024-05,2024-05-31,2020-06-14,ACTUAL,2020-06-14,2020-06-14,ACTUAL,2020-06-14,,INTERVENTIONAL,,,A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache,A Randomized Double-blind Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache,WITHDRAWN,,PHASE4,0.0,ACTUAL,Spectrum Health - Lakeland,,2.0,,no longer recruiting or studying,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,OTHER,,,,,,,2020,0.0
NCT03275064,,2017-08-29,2023-09-04,,2024-10-07,2017-09-05,2017-09-07,ACTUAL,2024-01-23,2024-02-14,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2017-09-12,ACTUAL,2017-09-12,2024-10,2024-10-31,2022-09-06,ACTUAL,2022-09-06,2022-09-06,ACTUAL,2022-09-06,,INTERVENTIONAL,,,"Study of Safety, Tolerability, Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions and Knee Osteoarthritis.","A Two-part, Randomized, Placebo-controlled, Patient and Investigator Blinded, Study Investigating the Safety, Tolerability and Preliminary Efficacy of Intra-articular LNA043 Injections in Regenerating the Articular Cartilage of the Knee in Patients With Articular Cartilage Lesions (Part A) and in Patients With Knee Osteoarthritis (Part B).",COMPLETED,,PHASE2,142.0,ACTUAL,Novartis,"For several outcomes there was a loss in samples size, which may limit the interpretability of results. For Part B, subgroup 1 was defined to address heterogeneity in MRI quality, and to ensure validity of the reported data. P-values for T2 relaxation time are omitted, as there was an error in the calculation. For Part A, the protocol sample size section refers to a ratio for the primary analysis, but data was reported as superficial and deep cartilage layers separately. Both will be updated.",5.0,,,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,INDUSTRY,,,,,,,2022,1.0
NCT03610516,,2018-06-01,2024-06-13,,2024-10-07,2018-07-31,2018-08-01,ACTUAL,2024-07-17,2024-07-18,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2018-09-12,ACTUAL,2018-09-12,2024-10,2024-10-31,2023-06-29,ACTUAL,2023-06-29,2023-06-29,ACTUAL,2023-06-29,,INTERVENTIONAL,,,"Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis.","A Randomized, Placebo-controlled, Patient and Investigator Blinded, Study Investigating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Doses of CFZ533 in Patients With Moderately Active Proliferative Lupus Nephritis",COMPLETED,,PHASE2,57.0,ACTUAL,Novartis,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,INDUSTRY,,,,,,,2023,1.0
NCT04762277,,2021-02-18,2024-09-11,2022-09-13,2024-09-11,2021-02-18,2021-02-21,ACTUAL,2024-09-11,2024-10-09,ACTUAL,2022-09-13,2022-09-16,ACTUAL,2024-09-11,2024-10-09,ACTUAL,2021-04-06,ACTUAL,2021-04-06,2024-09,2024-09-30,2022-04-21,ACTUAL,2022-04-21,2022-01-19,ACTUAL,2022-01-19,,INTERVENTIONAL,,Safety Analysis Set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug.,A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa,"Randomized, Double-blind, Placebo-controlled, Study of Spesolimab in Patients With Moderate to Severe Hidradenitis Suppurativa",COMPLETED,,PHASE2,52.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,INDUSTRY,,,,,,,2022,1.0
NCT06048705,,2023-09-15,2023-11-20,,2023-11-24,2023-09-15,2023-09-21,ACTUAL,2023-11-24,2024-05-10,ACTUAL,,,,2023-11-24,2024-05-10,ACTUAL,2021-03-09,ACTUAL,2021-03-09,2023-11,2023-11-30,2023-06-08,ACTUAL,2023-06-08,2023-06-08,ACTUAL,2023-06-08,,INTERVENTIONAL,,,"Study of GSK3901961 In Previously Treated Advanced (Metastatic OR Unresectable) Synovial Sarcoma/ Myxoid/Round Cell Liposarcoma, and Previously Treated Metastatic Non-Small Cell Lung Cancer","Assessment of Safety and Recommended Phase 2 Dose of Autologous T Cells Engineered With an Affinity-enhanced TCR Targeting NYESO1 and LAGE1a, and Co-expressing CD8α (GSK3901961) in Participants With NYESO1 and/or LAGE1a Positive Previously Treated Advanced (Metastatic or Unresectable) Synovial Sarcoma / Myxoid/Round Cell Liposarcoma; or NYESO1 and/or LAGE1a Positive Previously Treated Metastatic Non-Small Cell Lung Cancer",TERMINATED,,PHASE1,7.0,ACTUAL,GlaxoSmithKline,,1.0,,The study was terminated due to a change in GSK's R\&D priorities.,f,,,,f,t,f,,,,,,"Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",http://www.gsk.com/en-gb/innovation/trials/data-transparency/,YES,Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,INDUSTRY,,,,,,,2023,0.0
NCT04569760,,2020-09-24,,,2021-03-22,2020-09-24,2020-09-30,ACTUAL,,,,,,,2021-03-22,2021-03-24,ACTUAL,2021-04,ESTIMATED,2021-04-30,2020-09,2020-09-30,2023-06,ESTIMATED,2023-06-30,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,,,Cannabinoids for the Treatment of Anxiety Disorders: An 8-Week Pilot Study,Cannabinoids for the Treatment of Anxiety Disorders: An 8-Week Pilot Study,WITHDRAWN,,PHASE3,0.0,ACTUAL,McMaster University,,2.0,,Project cancelled prior to commencing recruitment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,OTHER,,,,,,,2023,0.0
NCT03430544,,2018-01-29,,,2020-09-05,2018-02-05,2018-02-13,ACTUAL,,,,,,,2020-09-05,2020-09-09,ACTUAL,2018-04-04,ACTUAL,2018-04-04,2020-09,2020-09-30,2020-09-04,ACTUAL,2020-09-04,2020-09-04,ACTUAL,2020-09-04,,INTERVENTIONAL,,,Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder,"A Randomized, Single-blind, Placebo-controlled Phase II Study to Assess the Effects of Cariprazine on Brain and Behavior in Subjects With Cocaine Use Disorder",TERMINATED,,PHASE2,14.0,ACTUAL,University of Pennsylvania,,3.0,,"Low recruitment in final grant year, halted on-site research due to COVID-19 during NCE year.",f,,,,t,t,f,,,f,,,,,,,,2024-10-15 23:41:43.345167,2024-10-15 23:41:43.345167,OTHER,,,,,,,2020,0.0
NCT03490019,,2018-03-19,,,2019-04-16,2018-03-29,2018-04-06,ACTUAL,,,,,,,2019-04-16,2019-04-18,ACTUAL,2018-04-01,ESTIMATED,2018-04-01,2018-02,2018-02-28,2020-08,ESTIMATED,2020-08-31,2019-10,ESTIMATED,2019-10-31,,INTERVENTIONAL,BBS,,Treatment of Bardet-Biedl-Syndrome With Metformin for Evaluation of a Possible Visual Improvement,Treatment of Infantile and Juvenile Patients With Bardet-Biedl-Syndrome With Metformin. Evaluation of a Visual Improvement as a Side Effect of the Pediatric Treatment of Adipositas - a Prospective Pilot Study Without Control,WITHDRAWN,,PHASE2,0.0,ACTUAL,University Hospital Tuebingen,,1.0,,unrealizable wishes of national authorities,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,OTHER,,,,,,,2020,0.0
NCT04614467,,2020-10-29,,2023-10-02,2023-10-09,2020-10-29,2020-11-04,ACTUAL,,,,,2023-10-06,ACTUAL,2023-10-09,2023-10-17,ACTUAL,2020-10-29,ACTUAL,2020-10-29,2023-10,2023-10-31,2022-09-28,ACTUAL,2022-09-28,2022-09-28,ACTUAL,2022-09-28,,INTERVENTIONAL,FREEDOM,,A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction,"A Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CLBS16 in Subjects With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease",TERMINATED,,PHASE2,34.0,ACTUAL,"Lisata Therapeutics, Inc.",,2.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,INDUSTRY,,,,,,,2022,0.0
NCT02740699,,2016-04-14,2024-07-17,2022-11-21,2024-10-01,2016-04-14,2016-04-15,ESTIMATED,2024-10-01,2024-10-09,ACTUAL,2022-11-21,2022-12-01,ACTUAL,2024-10-01,2024-10-09,ACTUAL,2016-04-11,ACTUAL,2016-04-11,2022-03,2022-03-31,2022-03-11,ACTUAL,2022-03-11,2022-01-27,ACTUAL,2022-01-27,,INTERVENTIONAL,,,CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction,CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction,TERMINATED,,PHASE4,79.0,ACTUAL,National Institutes of Health Clinical Center (CC),Protocol was terminated early due to departure of Principal Investigator.,1.0,,Principal Investigator resigned and closed program,f,,,,,t,f,,,,,,,,,,,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,NIH,,,,,,,2022,0.0
NCT03496610,,2018-04-05,2024-02-06,,2024-02-06,2018-04-11,2018-04-12,ACTUAL,2024-02-06,2024-03-05,ACTUAL,,,,2024-02-06,2024-03-05,ACTUAL,2021-01-25,ACTUAL,2021-01-25,2024-02,2024-02-29,2023-02-23,ACTUAL,2023-02-23,2023-02-23,ACTUAL,2023-02-23,,INTERVENTIONAL,,The number of participants in the QL group excludes two subjects-- one subject who voluntarily withdrew and one who was withdrawn by the PI for a surgical site infection.,Surgeon Infiltration QL Block Comparison,Intraoperative Surgical Wound Infiltration vs Quadratus Lumborum (QL) Block for Post-operative Pain Control After Nephrectomy in Living Donor Kidney Transplant Patients,COMPLETED,,PHASE4,44.0,ACTUAL,Duke University,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,OTHER,,,,,,,2023,1.0
NCT04301011,,2020-03-04,,,2023-11-21,2020-03-06,2020-03-09,ACTUAL,,,,,,,2023-11-21,2023-11-27,ACTUAL,2020-06-02,ACTUAL,2020-06-02,2023-11,2023-11-30,2023-01-23,ACTUAL,2023-01-23,2023-01-23,ACTUAL,2023-01-23,,INTERVENTIONAL,RAPTOR,,Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors,"A Phase 1/2a, Multicenter, Open-label Trial of TBio-6517, an Oncolytic Vaccinia Virus, Administered Alone and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,27.0,ACTUAL,"Turnstone Biologics, Corp.",,8.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,INDUSTRY,,,,,,,2023,0.0
NCT03515837,,2018-04-23,2023-12-21,,2024-10-09,2018-04-23,2018-05-04,ACTUAL,2023-12-21,2024-01-17,ACTUAL,,,,2024-10-09,2024-10-10,ESTIMATED,2018-06-29,ACTUAL,2018-06-29,2024-10,2024-10-31,2023-10-02,ACTUAL,2023-10-02,2023-01-17,ACTUAL,2023-01-17,,INTERVENTIONAL,,,Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789),"A Randomized, Double-Blind, Phase 3 Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789)",COMPLETED,,PHASE3,492.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2023,1.0
NCT03142191,,2017-04-24,2022-12-22,,2023-06-06,2017-05-03,2017-05-05,ACTUAL,2023-06-06,2023-06-28,ACTUAL,,,,2023-06-06,2023-06-28,ACTUAL,2017-07-26,ACTUAL,2017-07-26,2023-06,2023-06-30,2021-12-24,ACTUAL,2021-12-24,2021-12-24,ACTUAL,2021-12-24,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis,"A Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis",TERMINATED,,PHASE2,138.0,ACTUAL,Celgene,,5.0,,Business objectives have changed.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,INDUSTRY,,,,,,,2021,0.0
NCT04123561,,2019-10-09,2024-04-19,,2024-09-12,2019-10-09,2019-10-11,ACTUAL,2024-09-12,2024-10-08,ACTUAL,,,,2024-09-12,2024-10-08,ACTUAL,2019-11-26,ACTUAL,2019-11-26,2024-09,2024-09-30,2022-02-03,ACTUAL,2022-02-03,2022-02-03,ACTUAL,2022-02-03,,INTERVENTIONAL,EXCELLENCE,The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.,Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain,"A Phase 3, Randomized, Double-blind, Placebo- and Active-controlled Study to Evaluate the Efficacy and Safety of TLC599 in Patients With Osteoarthritis of the Knee",COMPLETED,,PHASE3,504.0,ACTUAL,Taiwan Liposome Company,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,INDUSTRY,,,,,,,2022,1.0
NCT03646123,,2018-08-22,2023-11-03,,2024-10-08,2018-08-22,2018-08-24,ACTUAL,2023-12-20,2023-12-21,ACTUAL,,,,2024-10-08,2024-10-09,ACTUAL,2019-01-28,ACTUAL,2019-01-28,2024-10,2024-10-31,2024-08-23,ACTUAL,2024-08-23,2022-11-07,ACTUAL,2022-11-07,,INTERVENTIONAL,,,Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma,Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects,TERMINATED,,PHASE2,255.0,ACTUAL,Seagen Inc.,,3.0,,The study was prematurely discontinued as the sponsor believes the data collected is enough to show the safety and efficacy of the combinations studied in all cohorts. The decision was not based on any safety and/or efficacy concerns.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,INDUSTRY,,,,,,,2024,0.0
NCT04507906,,2020-08-08,,,2022-06-26,2020-08-08,2020-08-11,ACTUAL,,,,,,,2022-06-26,2022-06-28,ACTUAL,2020-11-02,ACTUAL,2020-11-02,2022-06,2022-06-30,2022-03-31,ACTUAL,2022-03-31,2022-03-31,ACTUAL,2022-03-31,,INTERVENTIONAL,,,Nivolumab Combined With Anlotinib as Re-challenge Treatment in Advanced NSCLC,Safety and Efficacy of Nivolumab Combined With Anlotinib in Advanced Non-small Cell Lung Cancer Patients Previously Treated With Checkpoint Inhibitor-A Single Center and Exploratory Study,COMPLETED,,PHASE1/PHASE2,21.0,ACTUAL,Shanghai Chest Hospital,,1.0,,,f,,,,,t,f,,,t,,,,,,UNDECIDED,,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,OTHER,,,,,,,2022,0.0
NCT03767543,,2018-12-05,,,2022-04-21,2018-12-05,2018-12-06,ACTUAL,,,,,,,2022-04-21,2022-04-25,ACTUAL,2019-03-11,ACTUAL,2019-03-11,2022-04,2022-04-30,2020-10-23,ACTUAL,2020-10-23,2020-10-23,ACTUAL,2020-10-23,,INTERVENTIONAL,LixilanOne CAN,,Study Comparing the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM),"A Randomized, 26-week, Open-label, 2-treatment Arm, Parallel Group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated Using a Simple Titration Algorithm (One Unit Daily Adjustment) Compared With Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated by Weekly Adjustment in Patients With Type 2 Diabetes Mellitus (T2DM)",COMPLETED,,PHASE3,265.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,f,f,,,f,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,INDUSTRY,,,,,,,2020,1.0
NCT04630158,,2020-11-12,2024-03-22,,2024-10-07,2020-11-12,2020-11-16,ACTUAL,2024-03-22,2024-04-18,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2021-04-21,ACTUAL,2021-04-21,2024-10,2024-10-31,2023-06-08,ACTUAL,2023-06-08,2023-06-07,ACTUAL,2023-06-07,,INTERVENTIONAL,,,Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP),"A 12-week Parallel Group, Randomized, Placebo-controlled, Double-blinded, Multi-center Study to Evaluate Efficacy and Safety of 2 Concentrations of SAF312 Eye Drops (5 mg/ml and 15 mg/ml) Used Twice-daily in the Treatment of Post-operative Corneal Induced Chronic Pain (CICP) Following Photorefractive Keratectomy (PRK) or Laser-assisted in Situ Keratomileusis (LASIK) Surgeries",COMPLETED,,PHASE2,153.0,ACTUAL,Novartis,,3.0,,,f,,,,f,t,f,,,,,,,,https://www.clinicalstudydatarequest.com/,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.",2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,INDUSTRY,,,,,,,2023,1.0
NCT05199090,,2021-12-17,2024-05-03,,2024-10-07,2022-01-05,2022-01-20,ACTUAL,2024-05-30,2024-05-31,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2022-02-10,ACTUAL,2022-02-10,2024-10,2024-10-31,2023-05-11,ACTUAL,2023-05-11,2023-05-11,ACTUAL,2023-05-11,,INTERVENTIONAL,,,"Study to Assess Safety, Tolerability and Efficacy of SC Administered MBL949 in Obese Participants With or Without T2DM","A Randomized, Placebo-controlled, Participant-and-investigator- Blinded, Sponsor Open-label Study to Evaluate the Safety, Tolerability, and Efficacy With Different Dosing Regimens of Subcutaneously Administered MBL949 in Obese Participants With or Without Type 2 Diabetes Mellitus",TERMINATED,,PHASE2,126.0,ACTUAL,Novartis,,6.0,,The tolerability to benefit ratio based on maximum weight loss observed was not considered favorable at the doses studied and the study was terminated early,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,INDUSTRY,,,,,,,2023,0.0
NCT04371523,,2020-04-28,,,2021-09-21,2020-04-28,2020-05-01,ACTUAL,,,,,,,2021-09-21,2021-09-27,ACTUAL,2020-05-01,ESTIMATED,2020-05-01,2021-09,2021-09-30,2020-08-30,ESTIMATED,2020-08-30,2020-07-31,ESTIMATED,2020-07-31,,INTERVENTIONAL,PROVIDE,,Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers,Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers (PROVIDE): A Parallel Randomized Controlled Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,St. Joseph's Healthcare Hamilton,,2.0,,"Study was not initiated due to evidence becoming available that did not support the use of hydroxychloroquine in this population, with potential risk of added harm",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 23:41:43.345167,2024-10-15 23:41:43.345167,OTHER,,,,,,,2020,0.0
NCT03713619,,2018-10-18,2023-06-23,2021-07-08,2024-10-07,2018-10-19,2018-10-22,ACTUAL,2024-08-29,2024-09-25,ACTUAL,,2024-09-25,ACTUAL,2024-10-07,2024-10-09,ACTUAL,2019-01-31,ACTUAL,2019-01-31,2024-10,2024-10-31,2022-07-26,ACTUAL,2022-07-26,2021-10-01,ACTUAL,2021-10-01,,INTERVENTIONAL,SUNSHINE,,This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).,"A Randomized, Double-blind, Multi-center Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNSHINE).",COMPLETED,,PHASE3,544.0,ACTUAL,Novartis,,4.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,INDUSTRY,,,,,,,2022,1.0
NCT04747197,,2021-02-06,,,2023-07-18,2021-02-09,2021-02-10,ACTUAL,,,,,,,2023-07-18,2023-07-19,ACTUAL,2021-01-20,ACTUAL,2021-01-20,2023-06,2023-06-30,2022-05-11,ACTUAL,2022-05-11,2022-05-11,ACTUAL,2022-05-11,,INTERVENTIONAL,,,First in Human Study to Evaluate the Safety and Tolerability of EYP-1901 in Patients With Wet Age Related Macular Degeneration (wAMD),"A Phase 1, Multicenter, Prospective, Open-Label, Dose Escalation Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), in Subjects With Wet AMD",COMPLETED,,PHASE1,17.0,ACTUAL,"EyePoint Pharmaceuticals, Inc.",,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 23:41:43.345167,2024-10-15 23:41:43.345167,INDUSTRY,,,,,,,2022,1.0
NCT02648932,,2016-01-04,2021-02-22,,2021-02-22,2016-01-06,2016-01-07,ESTIMATED,2021-02-22,2021-03-18,ACTUAL,,,,2021-02-22,2021-03-18,ACTUAL,2016-02-04,ACTUAL,2016-02-04,2021-02,2021-02-28,2020-04,ACTUAL,2020-04-30,2020-04,ACTUAL,2020-04-30,,INTERVENTIONAL,,,The Rapid Study: Randomized Phase II Study To Expedite Allogeneic Transplant With Immediate Haploidentical Plus Unrelated Cord Donor Search Versus Matched Unrelated Donor Search For AML And High-Risk MDS Patients,The Rapid Study: Randomized (RA) Phase (P) II Study To Expedite Allogeneic Transplant With Immediate (I) Haploidentical Plus Unrelated Cord Donor (D) Search Versus Matched Unrelated Donor Search For AML And High-Risk MDS Patients,TERMINATED,,PHASE2,9.0,ACTUAL,University of Chicago,,2.0,,Poor accrual,f,,,,f,,,,,,,,,,,,,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,OTHER,,,,,,,2020,0.0
NCT03678090,,2018-09-18,,,2020-03-03,2018-09-18,2018-09-19,ACTUAL,,,,,,,2020-03-03,2020-03-05,ACTUAL,2018-12-01,ESTIMATED,2018-12-01,2020-03,2020-03-31,2020-02-28,ACTUAL,2020-02-28,2020-02-28,ACTUAL,2020-02-28,,INTERVENTIONAL,,,The Safety and Efficacy of Fibrinolysis in Patients With an Indwelling Pleural Catheter for Multi-loculated Malignant Pleural Effusion.,The Safety and Efficacy of Fibrinolysis in Patients With an Indwelling Pleural Catheter for Multi-loculated Malignant Pleural Effusion: a Prospective Randomized Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,Yale University,,2.0,,"Local IRB recommended IND exemption from FDA, study timeline not able to be met.",f,,,,t,f,f,,,,,,,,,,,2024-10-15 23:41:43.345167,2024-10-15 23:41:43.345167,OTHER,,,,,,,2020,0.0
NCT03327272,,2017-10-26,,,2020-11-18,2017-10-26,2017-10-31,ACTUAL,,,,,,,2020-11-18,2020-11-20,ACTUAL,2018-05-22,ACTUAL,2018-05-22,2020-11,2020-11-30,2020-07-24,ACTUAL,2020-07-24,2020-07-24,ACTUAL,2020-07-24,,INTERVENTIONAL,,,Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion,Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion,WITHDRAWN,,PHASE3,0.0,ACTUAL,Rush University Medical Center,,2.0,,"Did not enroll, PI decided not to proceed.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 23:41:43.345167,2024-10-15 23:41:43.345167,OTHER,,,,,,,2020,0.0
NCT05252598,,2022-01-27,,,2023-03-16,2022-02-11,2022-02-23,ACTUAL,,,,,,,2023-03-16,2023-03-20,ACTUAL,2023-01,ESTIMATED,2023-01-31,2023-03,2023-03-31,2023-12,ESTIMATED,2023-12-31,2023-08,ESTIMATED,2023-08-31,,INTERVENTIONAL,MELO,,Mood and Cognitive Effects of Psilocybin in Healthy Participants,"Mood and Cognitive Effects of Low Doses of Psilocybin Observed in Healthy Subjects (MELO): A Blinded, Placebo-Controlled, Dose-Finding Study",WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Optimi Health Corporation,,6.0,,The sponsor no longer wishes to pursue the methods outlined in the protocol.,f,,,,f,f,f,,,,,,,,,NO,There is no plan to share data at this time.,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,INDUSTRY,,,,,,,2023,0.0
NCT03745638,,2018-11-15,2021-10-20,2020-12-22,2023-09-21,2018-11-15,2018-11-19,ACTUAL,2021-11-19,2021-12-17,ACTUAL,2020-12-22,2020-12-29,ACTUAL,2023-09-21,2023-09-28,ACTUAL,2018-12-20,ACTUAL,2018-12-20,2023-09,2023-09-30,2020-12-01,ACTUAL,2020-12-01,2019-12-23,ACTUAL,2019-12-23,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all participants who were randomized to the study.,Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (TRuE AD1) - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis,"A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults With Atopic Dermatitis",COMPLETED,,PHASE3,631.0,ACTUAL,Incyte Corporation,,7.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:20:56.476587,2024-10-14 22:20:56.476587,INDUSTRY,,,,,,,2020,1.0
NCT04648696,,2020-11-23,2023-11-30,,2024-02-12,2020-11-23,2020-12-01,ACTUAL,2024-02-12,2024-02-14,ACTUAL,,,,2024-02-12,2024-02-14,ACTUAL,2021-03-03,ACTUAL,2021-03-03,2022-09,2022-09-30,2022-10-31,ACTUAL,2022-10-31,2022-10-31,ACTUAL,2022-10-31,,INTERVENTIONAL,,,Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin,"Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin in Outpatient Parenteral Antibiotic Therapy: a Prospective, Randomized Trial",TERMINATED,,PHASE4,8.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,The study was closed due to slow enrollment.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 19:25:10.070833,2024-10-16 19:25:10.070833,OTHER,,,,,,,2022,0.0
NCT04322682,,2020-03-23,2021-08-10,,2021-09-03,2020-03-25,2020-03-26,ACTUAL,2021-09-03,2021-09-08,ACTUAL,,,,2021-09-03,2021-09-08,ACTUAL,2020-03-23,ACTUAL,2020-03-23,2021-09,2021-09-30,2021-01-21,ACTUAL,2021-01-21,2021-01-21,ACTUAL,2021-01-21,,INTERVENTIONAL,COVID-19,Characteristics of the patients at randomisation in the intent-to-treat population.,Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA),Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA),TERMINATED,,PHASE3,4506.0,ACTUAL,Montreal Heart Institute,"Due to several considerations (logistical, human and budgetary), the study was stopped early. Furthermore, stopping the study after approximately 4500 patients had completed their 30-day follow-up would allow to communicate results in January 2021 in the hope of preventing complications of COVID-19 in ambulatory patients, instead of delivering results anywhere between April and October 2021 at a time when vaccination efforts might be successful.",2.0,,"Due to several considerations (logistical, human and budgetary), the study was stopped early.",f,,,,t,t,f,,,f,,,,,,,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,OTHER,,,,,,,2021,0.0
NCT04935359,,2021-06-21,,,2024-10-08,2021-06-21,2021-06-23,ACTUAL,,,,,,,2024-10-08,2024-10-09,ACTUAL,2021-09-30,ACTUAL,2021-09-30,2024-10,2024-10-31,2024-08-13,ACTUAL,2024-08-13,2024-08-13,ACTUAL,2024-08-13,,INTERVENTIONAL,,,Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2,"A Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2",COMPLETED,,PHASE3,511.0,ACTUAL,Novartis,,3.0,,,,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2024,0.0
NCT04053764,,2019-08-09,2024-03-20,,2024-10-07,2019-08-09,2019-08-12,ACTUAL,2024-05-08,2024-06-04,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2019-12-10,ACTUAL,2019-12-10,2024-10,2024-10-31,2023-03-20,ACTUAL,2023-03-20,2023-03-20,ACTUAL,2023-03-20,,INTERVENTIONAL,STEADFAST,The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.,Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease,"A Phase II, Multicenter, Randomized, Open Label Two Arm Study Evaluating the Effect of Crizanlizumab + Standard of Care and Standard of Care Alone on Renal Function in Sickle Cell Disease Patients ≥ 16 Years With Chronic Kidney Disease Due to Sickle Cell Nephropathy (STEADFAST)",COMPLETED,,PHASE2,58.0,ACTUAL,Novartis,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.",2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2023,1.0
NCT04139317,,2019-10-14,2024-01-15,2022-11-23,2024-10-07,2019-10-23,2019-10-25,ACTUAL,2024-01-15,2024-02-08,ACTUAL,2022-11-23,2022-11-28,ACTUAL,2024-10-07,2024-10-09,ACTUAL,2020-01-22,ACTUAL,2020-01-22,2024-10,2024-10-31,2023-02-07,ACTUAL,2023-02-07,2022-01-14,ACTUAL,2022-01-14,,INTERVENTIONAL,,,Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50%,"A Randomized, Open Label, Multicenter Phase II Study Evaluating the Efficacy and Safety of Capmatinib (INC280) Plus Pembrolizumab Versus Pembrolizumab Alone as First Line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer With PD-L1≥ 50%",TERMINATED,,PHASE2,76.0,ACTUAL,Novartis,,2.0,,Sponsor decision to terminate due to the lack of tolerability observed in patients treated with capmatinib and pembrolizumab in the combination arm as compared to patients treated with pembrolizumab alone in the pembrolizumab single agent arm,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2023,0.0
NCT03001661,,2016-11-11,,,2021-07-14,2016-12-20,2016-12-23,ESTIMATED,,,,,,,2021-07-14,2021-07-15,ACTUAL,2017-12-19,ACTUAL,2017-12-19,2021-07,2021-07-31,2021-02-06,ACTUAL,2021-02-06,2021-02-06,ACTUAL,2021-02-06,,INTERVENTIONAL,SOLVE,,An RCT of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt,A Randomised Controlled Trial of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt: the SOLVE Trial,COMPLETED,,PHASE3,674.0,ACTUAL,Birmingham Women's NHS Foundation Trust,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,Investigators will not be sharing individual patient data with other research studies,2024-10-14 22:26:35.083762,2024-10-14 22:26:35.083762,OTHER_GOV,,,,,,,2021,1.0
NCT04522817,,2020-08-20,,,2024-10-07,2020-08-20,2020-08-21,ACTUAL,,,,,,,2024-10-07,2024-10-09,ACTUAL,2020-10-05,ACTUAL,2020-10-05,2024-10,2024-10-31,2021-05,ESTIMATED,2021-05-31,2021-05,ESTIMATED,2021-05-31,,INTERVENTIONAL,,,CLBS119 for Repair of COVID-19 Induced Pulmonary Damage,CLBS119 (Autologous Peripheral Blood Derived CD34+ Cells) for Repair of COVID-19 Induced Pulmonary Damage,WITHDRAWN,,PHASE1,0.0,ACTUAL,"Lisata Therapeutics, Inc.",,1.0,,"Acute COVID-19 treatments have improved significantly leading to decreased use of ventilatory support. This, coupled with approval of a vaccine, has changed the profile/prognosis of patients and led to a lack of patients with long-term hypoxia.",f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2021,0.0
NCT03437070,,2018-02-10,,,2019-03-14,2018-02-10,2018-02-19,ACTUAL,,,,,,,2019-03-14,2019-03-18,ACTUAL,2019-06,ESTIMATED,2019-06-30,2019-03,2019-03-31,2023-06,ESTIMATED,2023-06-30,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,"Trabectedin, Doxorubicin and Olaratumab in Patients With Metastatic or Recurrent Leiomyosarcoma",A Phase I Study of Trabectedin in Combination With Fixed Doses of Doxorubicin and Olaratumab in Patients With Metastatic or Recurrent Leiomyosarcoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Miami,,1.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,OTHER,,,,,,,2023,0.0
NCT04043455,,2019-08-01,2022-08-05,2022-04-28,2022-09-15,2019-08-01,2019-08-02,ACTUAL,2022-09-15,2022-10-12,ACTUAL,2022-09-15,2022-10-12,ACTUAL,2022-09-15,2022-10-12,ACTUAL,2019-07-24,ACTUAL,2019-07-24,2022-09,2022-09-30,2021-04-29,ACTUAL,2021-04-29,2021-04-29,ACTUAL,2021-04-29,,INTERVENTIONAL,CAPTIVATE,Full Analysis Set comprises of all randomized participants irrespective of whether they received study treatment.,Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D),"A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of Olorinab in Subjects With Irritable Bowel Syndrome Experiencing Abdominal Pain",TERMINATED,,PHASE2,273.0,ACTUAL,Arena Pharmaceuticals,,5.0,,Business Decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,INDUSTRY,,,,,,,2021,0.0
NCT04579666,,2020-09-22,,,2024-02-12,2020-10-01,2020-10-08,ACTUAL,,,,,,,2024-02-12,2024-02-14,ACTUAL,2020-09-30,ACTUAL,2020-09-30,2024-02,2024-02-29,2023-07-13,ACTUAL,2023-07-13,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,,,MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS),"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Subjects With Amyotrophic Lateral Sclerosis (ALS)",TERMINATED,,PHASE2,249.0,ACTUAL,"Apellis Pharmaceuticals, Inc.",,2.0,,"The study did not meet primary endpoint at Week 52. The study also did not meet key secondary efficacy endpoints. Pegcetacoplan (APL-2) was well tolerated in the study, and the data were consistent with the established safety profile.",f,,,,t,t,f,,,,,,,,,,,2024-10-14 22:26:35.083762,2024-10-14 22:26:35.083762,INDUSTRY,,,,,,,2023,0.0
NCT03506620,,2018-04-13,,,2020-05-18,2018-04-23,2018-04-24,ACTUAL,,,,,,,2020-05-18,2020-05-20,ACTUAL,2019-01,ESTIMATED,2019-01-31,2020-05,2020-05-31,2020-02-07,ACTUAL,2020-02-07,2020-02-07,ACTUAL,2020-02-07,,INTERVENTIONAL,,,The Role of Nerve Blocks in Hip Arthroscopy,The Role of Nerve Blocks in Hip Arthroscopy,WITHDRAWN,,PHASE4,0.0,ACTUAL,Columbia University,,2.0,,Unforeseen cost restrictions of the drug halted the execution of this study altogether.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-14 22:26:35.083762,2024-10-14 22:26:35.083762,OTHER,,,,,,,2020,0.0
NCT05846646,,2023-04-27,,,2024-10-07,2023-04-27,2023-05-06,ACTUAL,,,,,,,2024-10-07,2024-10-09,ACTUAL,2023-06-28,ACTUAL,2023-06-28,2024-10,2024-10-31,2024-09-16,ACTUAL,2024-09-16,2024-09-16,ACTUAL,2024-09-16,,INTERVENTIONAL,,,Study of PULSAR-ICI +/- IMSA101 in Patients With Oligometastatic NSCLC and RCC,Phase 2 Randomized Clinical Trial Comparing the Safety and Efficacy of PULSAR-Integrated Radiotherapy + Pembrolizumab or Nivolumab Administered With or Without STING-Agonist IMSA101 in Patients With Oligometastatic NSCLC and RCC,TERMINATED,,PHASE2,6.0,ACTUAL,ImmuneSensor Therapeutics Inc.,,2.0,,Slow enrollment.,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2024,0.0
NCT03452137,,2018-02-25,2024-09-16,,2024-09-16,2018-02-28,2018-03-02,ACTUAL,2024-09-16,2024-10-09,ACTUAL,,,,2024-09-16,2024-10-09,ACTUAL,2018-04-03,ACTUAL,2018-04-03,2024-09,2024-09-30,2024-03-06,ACTUAL,2024-03-06,2023-09-27,ACTUAL,2023-09-27,,INTERVENTIONAL,IMvoke010,"Intent-to-Treat (ITT) population included all randomized participants, regardless of whether they received any of the assigned treatment.",A Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck,"A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck",TERMINATED,,PHASE3,406.0,ACTUAL,Hoffmann-La Roche,,2.0,,Decision to terminate the study as its primary endpoint of investigator-assessed event free survival (INV-EFS) was not met at its final EFS analysis. No new safety signals were identified.,f,,,,,t,f,,,,,,,,,,,2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2024,0.0
NCT03201445,,2017-06-26,2023-07-04,2021-07-27,2024-10-08,2017-06-26,2017-06-28,ACTUAL,2023-11-16,2023-12-06,ACTUAL,,2023-12-06,ACTUAL,2024-10-08,2024-10-09,ACTUAL,2017-07-11,ACTUAL,2017-07-11,2024-10,2024-10-31,2023-10-24,ACTUAL,2023-10-24,2020-11-20,ACTUAL,2020-11-20,,INTERVENTIONAL,MANTA,The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug.,Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease,"A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease",TERMINATED,,PHASE2,139.0,ACTUAL,Galapagos NV,The study was terminated based on the sponsor's decision for reasons other than safety.,2.0,,Early Termination for Reasons other than Safety,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2023,0.0
NCT04419467,,2020-06-03,2023-10-24,,2023-12-05,2020-06-03,2020-06-05,ACTUAL,2023-12-05,2023-12-06,ACTUAL,,,,2023-12-05,2023-12-06,ACTUAL,2020-09-14,ACTUAL,2020-09-14,2023-12,2023-12-31,2022-10-24,ACTUAL,2022-10-24,2022-10-24,ACTUAL,2022-10-24,,INTERVENTIONAL,,Intent-to-Treat Analysis Set,Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease,"A Phase 2a, Double-blind, Randomized, Placebo-controlled, Proof of Concept Study of Vascular Endothelial Growth Factor (VEGF)-B Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease",COMPLETED,,PHASE2,114.0,ACTUAL,CSL Behring,,3.0,,,f,,,,t,t,f,,,,,,IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.,Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.~An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.~The requesting party must execute an appropriate data sharing agreement before IPD will be made available.,,YES,"CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.~Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.~If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.",2024-10-14 22:26:35.083762,2024-10-14 22:26:35.083762,INDUSTRY,,,,,,,2022,1.0
NCT04111445,,2019-09-11,,,2021-09-03,2019-09-30,2019-10-01,ACTUAL,,,,,,,2021-09-03,2021-09-10,ACTUAL,2019-08-29,ACTUAL,2019-08-29,2021-09,2021-09-30,2021-04-27,ACTUAL,2021-04-27,2021-04-27,ACTUAL,2021-04-27,,INTERVENTIONAL,,,Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors,"First-in-human (FIH), Open-Label, Phase I (Dose Escalation) Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors",TERMINATED,,PHASE1,1.0,ACTUAL,Adagene Inc,,1.0,,Study discontinued due to business decision.,f,,,,,t,f,,,,,,,,,,,2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2021,0.0
NCT03997760,,2019-06-14,2023-10-06,,2024-04-22,2019-06-24,2019-06-25,ACTUAL,2024-04-22,2024-04-23,ACTUAL,,,,2024-04-22,2024-04-23,ACTUAL,2019-10-21,ACTUAL,2019-10-21,2024-04,2024-04-30,2022-10-26,ACTUAL,2022-10-26,2022-10-26,ACTUAL,2022-10-26,,INTERVENTIONAL,RAISE,The Safety Analysis Set (SAS) included all participants randomized and who received any dose of the investigational product (IP).,A Study of SHP655 (rADAMTS13) in Sickle Cell Disease,"A Phase 1 Randomized, Double-blind, Placebo-controlled, Multicenter, Ascending Dose, Safety and PK/PD Study of SHP655 (rADAMTS13) in Sickle Cell Disease at Baseline Health",COMPLETED,,PHASE1,19.0,ACTUAL,Takeda,,2.0,,,f,,,,,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,INDUSTRY,,,,,,,2022,1.0
NCT04597632,,2020-10-01,2024-02-27,,2024-10-07,2020-10-15,2020-10-22,ACTUAL,2024-04-02,2024-04-04,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2020-12-16,ACTUAL,2020-12-16,2024-10,2024-10-31,2023-03-28,ACTUAL,2023-03-28,2023-03-28,ACTUAL,2023-03-28,,INTERVENTIONAL,TALON Ext,Full Analysis Set composed of all subjects who received at least one dose of study treatment in the extension study.,An Extension Study Assessing the Efficacy and Safety of Brolucizumab in a Treat-to-Control Regimen in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study,"A 56-week Phase IIIb/IV, Open-label, One-arm Extension Study to Assess the Efficacy and Safety of Brolucizumab 6 mg in a Treat-to-Control Regimen With Maximum Treatment Intervals up to 20 Weeks for the Treatment of Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study",COMPLETED,,PHASE3,248.0,ACTUAL,Novartis,,1.0,,,f,,,,f,t,f,,,,,,,,https://www.clinicalstudydatarequest.com/,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.",2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2023,1.0
NCT03207529,,2017-06-30,,,2024-10-08,2017-06-30,2017-07-02,ACTUAL,,,,,,,2024-10-08,2024-10-10,ESTIMATED,2019-06-07,ACTUAL,2019-06-07,2024-10,2024-10-31,2023-12-31,ACTUAL,2023-12-31,2023-12-31,ACTUAL,2023-12-31,,INTERVENTIONAL,,,Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast Cancer,Phase Ib Study of BYL719 (Alpelisib) in Combination With Androgen Receptor Inhibitor (Enzalutamide) in Patients With Androgen Receptor (AR)-Positive and PTEN Positive Metastatic Breast Cancer,COMPLETED,,PHASE1,18.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,OTHER,,,,,,,2023,1.0
NCT03674541,,2018-09-11,2022-05-31,,2022-10-14,2018-09-14,2018-09-17,ACTUAL,2022-09-06,2022-10-04,ACTUAL,,,,2022-10-14,2022-11-08,ACTUAL,2020-01-14,ACTUAL,2020-01-14,2022-10,2022-10-31,2021-12-20,ACTUAL,2021-12-20,2021-12-05,ACTUAL,2021-12-05,,INTERVENTIONAL,,"Data was collected for all 45 patient, 23 females on study drug, 22 on placebo (16 females, 6 males).",The Exercise Response to Pharmacologic Cholinergic Stimulation in Myalgic Encephalomyelitis / Chronic Fatigue Syndrome,The Exercise Response to Pharmacologic Cholinergic Stimulation in Myalgic Encephalomyelitis / Chronic Fatigue Syndrome,COMPLETED,,PHASE2,45.0,ACTUAL,Brigham and Women's Hospital,"Of the 45 subjects, 39 were female and 6 were male. Although this gender distribution is reflective of the gender differences seen in ME/CFS, our small sample size produced a randomization error where all 6 male participants were placed in the placebo group. We elected not to include males in the statistical analysis as their response to exercise was discordant compared to females who received placebo. In addition, reducing the sample size increases the likelihood of type II errors.",2.0,,,f,,,,f,t,f,,,t,,,Beginning 9 months and ending 36 months following article publication.,"Proposals should be directed to jsquires1@bwh.harvard.edu. To gain access, data requestors will need to sign a data access agreement.",,YES,"Individual participant data that underlie the results reported in this article, after de-identification(text, tables, figures, and appendices) will be available for researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.",2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,OTHER,,,,,,,2021,1.0
NCT02323126,,2014-12-18,2021-03-30,,2022-01-31,2014-12-18,2014-12-23,ESTIMATED,2021-05-20,2021-06-15,ACTUAL,,,,2022-01-31,2022-02-28,ACTUAL,2015-02-09,ACTUAL,2015-02-09,2022-01,2022-01-31,2021-02-05,ACTUAL,2021-02-05,2019-09-23,ACTUAL,2019-09-23,,INTERVENTIONAL,,,Study of Efficacy and Safety of Nivolumab in Combination With EGF816 and of Nivolumab in Combination With INC280 in Patients With Previously Treated Non-small Cell Lung Cancer,"A Phase II, Multicenter, Open-label Study of EGF816 in Combination With Nivolumab in Adult Patients With EGFR Mutated Non-small Cell Lung Cancer and of INC280 in Combination With Nivolumab in Adult Patients With cMet Positive Non-small Cell Lung Cancer",TERMINATED,,PHASE2,64.0,ACTUAL,Novartis,,3.0,,Sponsor decision due to low patient recruitment caused by the change in the treatment landscape of NSCLC.,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,INDUSTRY,,,,,,,2021,0.0
NCT04901988,,2021-04-16,,,2024-10-07,2021-05-20,2021-05-26,ACTUAL,,,,,,,2024-10-07,2024-10-09,ACTUAL,2021-11-08,ACTUAL,2021-11-08,2023-04,2023-04-30,2023-01-30,ACTUAL,2023-01-30,2023-01-30,ACTUAL,2023-01-30,,INTERVENTIONAL,DETECTION,,Circulating Tumour DNA guidEd Therapy for Stage IIB/C mElanoma After surgiCal resecTION,Circulating Tumour DNA guidEd Therapy for Stage IIB/C mElanoma After surgiCal resecTION (DETECTION),TERMINATED,,PHASE2/PHASE3,8.0,ACTUAL,The Christie NHS Foundation Trust,,2.0,,Closed earlier than expected due to the need for a redesign to reflect the recent change in standard of care guidelines. New design will include these treatments.,f,,,,t,t,f,,,t,,,Early termination of the study was declared prior to any patients being randomised which means we are unable to perform any evaluation of result or outcome.,,,YES,"At the end of the trial, after the primary results have been published, the de-identified individual participant data (IPD) and associated documentation (e.g. protocol, statistical analysis plan, annotated blank CRF) will be prepared in order to be shared with external researchers. All requests for access to the IPD will be reviewed by an internal committee at the Clinical Trials Unit (CTU) and discussed with the Chief Investigator in accordance with the CTU policy on data sharing. All data sharing must be authorised by the Sponsor.",2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,OTHER,,,,,,,2023,0.0
NCT04288856,,2020-02-26,,,2023-04-13,2020-02-26,2020-02-28,ACTUAL,,,,,,,2023-04-13,2023-04-18,ACTUAL,2020-04-28,ACTUAL,2020-04-28,2023-04,2023-04-30,2022-05-03,ACTUAL,2022-05-03,2022-05-03,ACTUAL,2022-05-03,,INTERVENTIONAL,,,"Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults C9ORF72-Associated Amyotrophic Lateral Sclerosis (ALS)","An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults With C9ORF72-Associated Amyotrophic Lateral Sclerosis",TERMINATED,,PHASE1,75.0,ACTUAL,Biogen,,4.0,,"There was no evidence of benefit across efficacy endpoints in the randomized trial, 245AS101. Accordingly, Biogen has made the difficult decision to discontinue the BIIB078 program including this open label extension trial, 245AS102.",f,,,,f,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-14 22:26:35.083762,2024-10-14 22:26:35.083762,INDUSTRY,,,,,,,2022,0.0
NCT04386616,,2020-05-11,2021-12-16,,2022-01-05,2020-05-12,2020-05-13,ACTUAL,2022-01-05,2022-01-10,ACTUAL,,,,2022-01-05,2022-01-10,ACTUAL,2020-06-02,ACTUAL,2020-06-02,2022-01,2022-01-31,2021-02-12,ACTUAL,2021-02-12,2021-01-08,ACTUAL,2021-01-08,,INTERVENTIONAL,COVASTIL,"Modified Intent-to-Treat (mITT) Population: all participants randomized in the study who received at least one dose of study drug, with participants grouped according to the treatment assigned at randomization.",A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia,"A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MSTT1041A or UTTR1147A in Patients With Severe COVID-19 Pneumonia",COMPLETED,,PHASE2,396.0,ACTUAL,"Genentech, Inc.",,3.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).~For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2021,1.0
NCT03207867,,2017-06-19,2024-02-05,,2024-10-07,2017-06-30,2017-07-05,ACTUAL,2024-02-05,2024-03-01,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2017-08-28,ACTUAL,2017-08-28,2024-10,2024-10-31,2023-02-14,ACTUAL,2023-02-14,2023-02-13,ACTUAL,2023-02-13,,INTERVENTIONAL,,,A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma,"A Phase 2, Multi-center, Open Label Study of NIR178 in Combination With PDR001 in Patients With Selected Advanced Solid Tumors and Non-Hodgkin Lymphoma",TERMINATED,,PHASE2,315.0,ACTUAL,Novartis,,4.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2023,0.0
NCT04812548,,2021-02-23,2024-02-14,,2024-10-07,2021-03-19,2021-03-23,ACTUAL,2024-05-13,2024-06-11,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2021-05-31,ACTUAL,2021-05-31,2024-10,2024-10-31,2023-05-08,ACTUAL,2023-05-08,2023-05-08,ACTUAL,2023-05-08,,INTERVENTIONAL,STIMULUS-MDS3,Full Analysis Set (FAS):,A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants,"A Single-arm, Open-label, Phase II Study of Sabatolimab in Combination With Azacitidine and Venetoclax in Adult Participants With High or Very High Risk Myelodysplastic Syndromes (MDS) as Per IPSS-R Criteria",TERMINATED,,PHASE2,20.0,ACTUAL,Novartis,,1.0,,Study was stopped following a strategic decision from the Sponsor. It was not based on any safety findings or safety concerns with sabatolimab.,f,,,,f,t,f,,,,,,,,https://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.",2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2023,0.0
NCT03547908,,2018-05-24,2023-02-17,,2024-03-15,2018-05-24,2018-06-06,ACTUAL,2023-02-17,2023-03-15,ACTUAL,,,,2024-03-15,2024-03-19,ACTUAL,2018-05-30,ACTUAL,2018-05-30,2024-03,2024-03-31,2024-03-07,ACTUAL,2024-03-07,2022-02-25,ACTUAL,2022-02-25,,INTERVENTIONAL,Alliance,,"Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults","A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults",COMPLETED,,PHASE3,244.0,ACTUAL,Gilead Sciences,,3.0,,,f,,,,t,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gileadclinicaltrials.com/transparency-policy#Commitment,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment",2024-10-14 22:26:35.083762,2024-10-14 22:26:35.083762,INDUSTRY,,,,,,,2024,1.0
NCT05203419,,2022-01-10,,,2024-10-07,2022-01-10,2022-01-24,ACTUAL,,,,,,,2024-10-07,2024-10-09,ACTUAL,2022-03-15,ACTUAL,2022-03-15,2024-10,2024-10-31,2023-06-04,ACTUAL,2023-06-04,2023-06-04,ACTUAL,2023-06-04,,INTERVENTIONAL,,,Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE),"A Two-part, Randomized, Investigator- and Participant- Blinded, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MHS552 in Adult Participants With Systemic Lupus Erythematosus (SLE)",TERMINATED,,PHASE1,8.0,ACTUAL,Novartis,,6.0,,Sponsor Decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2023,0.0
NCT03782064,,2018-12-13,2022-03-14,,2023-06-16,2018-12-18,2018-12-20,ACTUAL,2022-08-10,2022-09-01,ACTUAL,,,,2023-06-16,2023-06-22,ACTUAL,2019-02-22,ACTUAL,2019-02-22,2023-06,2023-06-30,2021-01-31,ACTUAL,2021-01-31,2021-01-31,ACTUAL,2021-01-31,,INTERVENTIONAL,,Participants who Initiated Treatment,Dendritic Cell (DC)/Myeloma Fusions in Combination With Nivolumab in Patients With Relapsed Multiple Myeloma,A Phase II Trial of Vaccination With Dendritic Cell (DC)/Myeloma Fusions in Combination With Nivolumab in Patients With Relapsed Multiple Myeloma,TERMINATED,,PHASE2,5.0,ACTUAL,Beth Israel Deaconess Medical Center,"Due to withdrawal of funding, this study was halted prematurely. Only two participants were treated and we were unable to analyze the data in any meaningful way due to the small sample size.",1.0,,Funding,f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor-Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-14 22:26:35.083762,2024-10-14 22:26:35.083762,OTHER,,,,,,,2021,0.0
NCT02294461,,2014-11-13,2016-12-12,2016-09-01,2024-09-17,2014-11-17,2014-11-19,ESTIMATED,2017-03-01,2017-04-12,ACTUAL,2016-09-01,2016-09-30,ESTIMATED,2024-09-17,2024-10-09,ACTUAL,2014-04-23,ACTUAL,2014-04-23,2024-09,2024-09-30,2024-07-17,ACTUAL,2024-07-17,2015-09-20,ACTUAL,2015-09-20,,INTERVENTIONAL,,Intent-to-treat (ITT) population consisted of all randomized participants in the study. Data cutoff date was 04 Nov 2020.,An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants,"Asian Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral Enzalutamide in Chemotherapy Naïve Subjects With Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy",COMPLETED,,PHASE3,395.0,ACTUAL,Astellas Pharma Inc,,3.0,,,f,,,,t,t,f,,,t,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://www.clinicalstudydatarequest.com/,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2024,1.0
NCT01585402,,2012-04-24,2022-07-13,,2022-09-09,2012-04-24,2012-04-25,ESTIMATED,2022-09-09,2022-10-04,ACTUAL,,,,2022-09-09,2022-10-04,ACTUAL,2012-08-20,ACTUAL,2012-08-20,2021-08,2021-08-31,2021-08-06,ACTUAL,2021-08-06,2021-08-06,ACTUAL,2021-08-06,,INTERVENTIONAL,,,Etidronate for Arterial Calcifications Due to Deficiency in CD73 (ACDC),"An Open-label, Non-Randomized, Single-Arm Pilot Study to Evaluate the Effectiveness of Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC)",COMPLETED,,PHASE2,7.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,,f,,,,,t,t,,,,,,,,,,,2024-10-14 22:26:35.083762,2024-10-14 22:26:35.083762,NIH,,,,,,,2021,1.0
NCT03990597,,2019-06-17,,,2024-10-07,2019-06-17,2019-06-19,ACTUAL,,,,,,,2024-10-07,2024-10-09,ACTUAL,2019-08-19,ACTUAL,2019-08-19,2020-11,2020-11-30,2020-11-24,ACTUAL,2020-11-24,2020-11-24,ACTUAL,2020-11-24,,INTERVENTIONAL,,,StrataXRT in Preventing Radiation Dermatitis in Pediatric Patients Undergoing Radiation Therapy to the Brain or Spinal Cord,"A Pilot Study of StrataXRT, a Topical Silicone Barrier, to Prevent Auricular Radiation Dermatitis in Pediatric Patients Undergoing Proton Cerebrospinal Radiation Therapy",WITHDRAWN,,PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Per PI,,,,,f,f,t,,,,,,,,,,,2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,OTHER,,,,,,,2020,0.0
NCT04575064,,2020-09-30,,,2024-10-07,2020-10-02,2020-10-05,ACTUAL,,,,,,,2024-10-07,2024-10-09,ACTUAL,2020-06-29,ACTUAL,2020-06-29,2024-10,2024-10-31,2022-11,ESTIMATED,2022-11-30,2022-03,ESTIMATED,2022-03-31,,INTERVENTIONAL,,,An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care - WHO-SOLIDARITY-GERMANY,An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care - WHO-SOLIDARITY-GERMANY,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,"Klinikum Bremen-Mitte, gGmbH",,2.0,,Explanation will be submitted later.,f,,,,,f,f,,,,,,,,,,,2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,OTHER,,,,,,,2022,0.0
NCT04058067,,2019-08-14,2023-11-01,,2024-10-07,2019-08-14,2019-08-15,ACTUAL,2024-05-15,2024-09-19,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2019-08-23,ACTUAL,2019-08-23,2024-10,2024-10-31,2023-01-31,ACTUAL,2023-01-31,2023-01-31,ACTUAL,2023-01-31,,INTERVENTIONAL,KINGLET,,To Compare Brolucizumab to Aflibercept in Chinese Patients With Visual Impairment Due to Diabetic Macular Edema,"A One-Year, Randomized, Double-Masked, Multicenter, Phase III, Two-Arm Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Chinese Patients With Visual Impairment Due to Diabetic Macular Edema",COMPLETED,,PHASE3,266.0,ACTUAL,Novartis,,2.0,,,f,,,,t,f,f,,,,,,,,https://clinicalstudydatarequest.com/,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2023,1.0
NCT04877457,,2021-04-30,2024-06-10,,2024-10-01,2021-05-03,2021-05-07,ACTUAL,2024-10-01,2024-10-09,ACTUAL,,,,2024-10-01,2024-10-09,ACTUAL,2022-02-15,ACTUAL,2022-02-15,2024-10,2024-10-31,2023-06-12,ACTUAL,2023-06-12,2023-06-12,ACTUAL,2023-06-12,,INTERVENTIONAL,CELLO,,Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease.,"A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Ocrelizumab in Patients With Radiologically Isolated Syndrome",TERMINATED,,PHASE4,3.0,ACTUAL,Yale University,Early termination leading to small number of subjects analyzed.,2.0,,Slow enrollment,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,OTHER,,,,,,,2023,0.0
NCT06079320,,2023-10-06,,,2024-10-03,2023-10-06,2023-10-12,ACTUAL,,,,,,,2024-10-03,2024-10-08,ACTUAL,2023-12-08,ACTUAL,2023-12-08,2024-10,2024-10-31,2024-09-30,ACTUAL,2024-09-30,2024-09-30,ACTUAL,2024-09-30,,INTERVENTIONAL,,,A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection,"AN INTERVENTIONAL PHASE 2/3, ADAPTIVE, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ORAL SISUNATOVIR COMPARED WITH PLACEBO IN NON-HOSPITALIZED SYMPTOMATIC ADULTS WITH RESPIRATORY SYNCYTIAL VIRUS INFECTION WHO ARE AT RISK OF PROGRESSION TO SEVERE ILLNESS",TERMINATED,,PHASE2/PHASE3,16.0,ACTUAL,Pfizer,,2.0,,Study discontinued due to business reasons. There were no safety concerns in the decision to stop study and no changes to sponsor's assessment of the risk-benefit profile for participants who received sisunatovir in the study.,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2024,0.0
NCT04847440,,2021-04-06,,,2022-11-15,2021-04-12,2021-04-19,ACTUAL,,,,,,,2022-11-15,2022-11-18,ACTUAL,2021-03-30,ACTUAL,2021-03-30,2022-11,2022-11-30,2022-09-01,ACTUAL,2022-09-01,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,,,A Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepatitis D Virus Coinfection,"A Phase 2A Randomized, Double-blinded, Placebo-controlled, Multicenter, Dose Ranging Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepatitis D Virus Coinfection",TERMINATED,,PHASE2,40.0,ACTUAL,"Antios Therapeutics, Inc",,4.0,,Terminated by the Sponsor,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 22:26:35.083762,2024-10-14 22:26:35.083762,INDUSTRY,,,,,,,2022,0.0
NCT03288818,,2017-09-18,,,2018-01-25,2017-09-18,2017-09-20,ACTUAL,,,,,,,2018-01-25,2018-01-29,ACTUAL,2018-08,ESTIMATED,2018-08-31,2018-01,2018-01-31,2021-12,ESTIMATED,2021-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Low Dose Total Skin Electron Beam Radiation Therapy and Mechlorethamine Hydrochloride Gel in Treating Patients With Mycosis Fungoides,IIS: Phase II Study of Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides,WITHDRAWN,,PHASE2,0.0,ACTUAL,Thomas Jefferson University,,1.0,,Funding discontinued,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,OTHER,,,,,,,2021,0.0
NCT03713593,,2018-10-18,2023-06-08,,2024-09-27,2018-10-18,2018-10-22,ACTUAL,2023-07-21,2023-07-24,ACTUAL,,,,2024-09-27,2024-10-10,ESTIMATED,2018-12-31,ACTUAL,2018-12-31,2024-09,2024-09-30,2024-09-24,ACTUAL,2024-09-24,2022-06-21,ACTUAL,2022-06-21,,INTERVENTIONAL,,,Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002),"A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002)",COMPLETED,,PHASE3,794.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2024,1.0
NCT03821376,,2019-01-25,2024-07-22,,2024-10-09,2019-01-28,2019-01-29,ACTUAL,2024-10-09,2024-10-10,ESTIMATED,,,,2024-10-09,2024-10-10,ESTIMATED,2019-07-16,ACTUAL,2019-07-16,2024-10,2024-10-31,2021-09-21,ACTUAL,2021-09-21,2021-09-21,ACTUAL,2021-09-21,,INTERVENTIONAL,,,Correlation of Renal Mass Pathologic Grade and Contrast Enhanced Ultrasound (CEUS),Correlation of Contrast Enhanced Ultrasound of Renal Masses With Pathologic Grade: A Prospective Comparison of Quantitative and Qualitative Findings,TERMINATED,,PHASE4,12.0,ACTUAL,Indiana University,,1.0,,Study stopped due to staffing issues that impacted ability to recruit.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,OTHER,,,,,,,2021,0.0
NCT04401410,,2020-05-21,,,2022-12-16,2020-05-21,2020-05-26,ACTUAL,,,,,,,2022-12-16,2022-12-19,ACTUAL,2020-11-04,ACTUAL,2020-11-04,2022-12,2022-12-31,2021-10-12,ACTUAL,2021-10-12,2021-10-12,ACTUAL,2021-10-12,,INTERVENTIONAL,BATIT,,Anti-SARS Cov-2 T Cell Infusions for COVID 19,BAT IT: Banked Anti-SARS Cov-2 T Cell Infusions for Treatment of COVID 19,TERMINATED,,PHASE1,4.0,ACTUAL,Baylor College of Medicine,,3.0,,"Due to trial's eligibility criteria and the low census of hospitalized COVID-19 patients meeting eligibility criteria, the Sponsor will be unable to enroll a meaningful number of patients in this single-center trial in a reasonable time frame.",f,,,,t,t,f,,,f,,,,,,,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,OTHER,,,,,,,2021,0.0
NCT03264989,,2017-08-04,2023-12-19,,2024-10-07,2017-08-25,2017-08-29,ACTUAL,2024-04-19,2024-04-23,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2017-12-19,ACTUAL,2017-12-19,2024-10,2024-10-31,2023-06-26,ACTUAL,2023-06-26,2023-06-26,ACTUAL,2023-06-26,,INTERVENTIONAL,,Full Analysis Set (FAS): Consisted of all patients to whom crizanlizumab had been assigned and who received at least 1 dose of study treatment.,Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC),"A Phase 2, Multicenter, Open-Label Study to Assess PK/PD of SEG101 (Crizanlizumab), With or Without Hydroxyurea/Hydroxycarbamide, in Sickle Cell Patients With Vaso-Occlusive Crisis",COMPLETED,,PHASE2,57.0,ACTUAL,Novartis,"This study provided a 5-year follow up (f/u) data that fully characterized the safety, tolerability \& treatment of the 5.0 mg/kg \& 7.5 mg/kg doses of crizanlizumab along with the initially planned PK \& PD data. As the goal of study f/u was reached, study was considered completed \& it was in line with the end of study as defined in the study protocol, the sponsor closed the study as the participants were no longer receiving intervention or being examined.",1.0,,,f,,,,f,t,f,,,,,,,,http://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2023,1.0
NCT04268303,,2020-02-11,2023-04-26,,2023-05-25,2020-02-11,2020-02-13,ACTUAL,2023-05-25,2023-06-18,ACTUAL,,,,2023-05-25,2023-06-18,ACTUAL,2020-01-24,ACTUAL,2020-01-24,2023-05,2023-05-31,2020-05-06,ACTUAL,2020-05-06,2020-05-06,ACTUAL,2020-05-06,,INTERVENTIONAL,SERENITY I,Safety population (all participants who received study drug). One participant enrolled and randomized to the 120 μg group was enrolled a second time at a different site and randomized to the 180 μg group. The data from the first enrollment and treatment (120 μg) were included in the efficacy analyses. The data from both enrollments (120 μg and 180 μg) were included in the safety analyses and counted separately for each treatment group.,Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia,"A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Determine Efficacy and Safety of BXCL501 In Agitation Associated With Schizophrenia",COMPLETED,,PHASE3,380.0,ACTUAL,BioXcel Therapeutics Inc,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,INDUSTRY,,,,,,,2020,1.0
NCT04988087,,2021-07-26,2024-01-16,,2024-10-07,2021-07-26,2021-08-03,ACTUAL,2024-01-16,2024-07-08,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2021-11-30,ACTUAL,2021-11-30,2024-10,2024-10-31,2023-03-07,ACTUAL,2023-03-07,2023-02-07,ACTUAL,2023-02-07,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)","A Multi-center, Randomized, Participant- and Investigator- Blinded, Placebo-controlled, Parallel Group Basket Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjögren's Syndrome or Mixed Connective Tissue Disease",TERMINATED,,PHASE2,30.0,ACTUAL,Novartis,,4.0,,Sponsor decision,f,,,,f,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2023,0.0
NCT03047330,,2017-02-07,2024-02-09,,2024-09-17,2017-02-07,2017-02-08,ESTIMATED,2024-09-17,2024-10-08,ACTUAL,,,,2024-09-17,2024-10-08,ACTUAL,2017-07-15,ACTUAL,2017-07-15,2024-09,2024-09-30,2022-08-01,ACTUAL,2022-08-01,2022-08-01,ACTUAL,2022-08-01,,INTERVENTIONAL,,,Menopausal Sleep Fragmentation and Body Fat Gain,Menopausal Sleep Fragmentation: Impact on Body Fat Gain Biomarkers in Women,COMPLETED,,PHASE4,41.0,ACTUAL,Brigham and Women's Hospital,,1.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,OTHER,,,,,,,2022,1.0
NCT04001647,,2019-06-21,,,2024-07-29,2019-06-26,2019-06-28,ACTUAL,,,,,,,2024-07-29,2024-07-31,ACTUAL,2019-06-01,ACTUAL,2019-06-01,2024-07,2024-07-31,2022-08-16,ACTUAL,2022-08-16,2022-08-16,ACTUAL,2022-08-16,,INTERVENTIONAL,,,Targeting ER Stress in Vascular Dysfunction,Targeting Endoplasmic Reticulum Stress in Aging- and Obesity-Induced Vascular Dysfunction,TERMINATED,,EARLY_PHASE1,17.0,ACTUAL,Colorado State University,,2.0,,IRB approval has been withdrawn,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,OTHER,,,,,,,2022,0.0
NCT04003896,,2019-06-25,2024-08-14,,2024-09-12,2019-06-28,2019-07-01,ACTUAL,2024-09-12,2024-10-08,ACTUAL,,,,2024-09-12,2024-10-08,ACTUAL,2021-09-24,ACTUAL,2021-09-24,2024-09,2024-09-30,2023-08-15,ACTUAL,2023-08-15,2023-08-15,ACTUAL,2023-08-15,,INTERVENTIONAL,,"The baseline analysis population includes all participants who were enrolled in the study before it was terminated. In this case, the study enrolled a total of 4 participants out of the planned 10.",A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma,A Pilot Study to Evaluate the Response and Tolerability of Verzenio (Abemaciclib) in Patients With Advanced Biliary Tract Carcinoma,TERMINATED,,PHASE2,4.0,ACTUAL,Milton S. Hershey Medical Center,Early termination leading to small numbers of subjects analyzed.,1.0,,The manufacturer and funder Eli Lilly requested to terminate the study,f,,,,t,t,f,,,,,,,,,,,2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,OTHER,,,,,tumor lesions,,2023,0.0
NCT03710915,,2018-09-29,,,2024-10-08,2018-10-15,2018-10-18,ACTUAL,,,,,,,2024-10-08,2024-10-10,ESTIMATED,2019-01-12,ACTUAL,2019-01-12,2023-09,2023-09-30,2023-06-28,ACTUAL,2023-06-28,2022-09-28,ACTUAL,2022-09-28,,INTERVENTIONAL,,,A Study of HG146 Capsule in Chinese Subjects with Relapsed and Refractory Multiple Myeloma,"A Phase I Study of Single-centre, Open-label Clinical Trial to Evaluate HG146 Capsule in the Treatment of Relapsed and Refractory Multiple Myeloma",TERMINATED,,PHASE1,3.0,ACTUAL,HitGen Inc.,,1.0,,Company decision,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2023,0.0
NCT04820530,,2021-03-25,2023-10-27,,2024-10-07,2021-03-25,2021-03-29,ACTUAL,2023-10-27,2023-11-15,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2021-07-19,ACTUAL,2021-07-19,2024-10,2024-10-31,2023-04-18,ACTUAL,2023-04-18,2022-11-02,ACTUAL,2022-11-02,,INTERVENTIONAL,APPOINT-PNH,,Study of Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy,"A Multicenter, Single-arm, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily Iptacopan in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy",COMPLETED,,PHASE3,40.0,ACTUAL,Novartis,,1.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient level data and supporting clinical documents from eligible studies. these requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2023,1.0
NCT04711902,,2021-01-14,2024-02-07,2023-04-26,2024-10-07,2021-01-14,2021-01-15,ACTUAL,2024-02-07,2024-07-19,ACTUAL,,2023-04-28,ACTUAL,2024-10-07,2024-10-09,ACTUAL,2021-06-24,ACTUAL,2021-06-24,2024-10,2024-10-31,2023-03-10,ACTUAL,2023-03-10,2022-06-02,ACTUAL,2022-06-02,,INTERVENTIONAL,,Randomized set: All participants who were randomized.,Study of Efficacy and Safety of Secukinumab in Chinese Subjects With Active PsA Compared to Placebo.,"A Phase III Randomized, Double-blind, Placebo Controlled, Multicenter, Bridging Study of Subcutaneous Secukinumab, to Demonstrate Efficacy After Sixteen Weeks of Treatment and to Assess Safety, Tolerability and Long-term Efficacy Follow-up to One Year in Chinese Subjects With Active Psoriatic Arthritis",COMPLETED,,PHASE3,41.0,ACTUAL,Novartis,,4.0,,,f,,,,f,f,f,,,,,,,,https://www.clinicalstudydatarequest.com,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2023,1.0
NCT05193604,,2021-12-28,,,2023-12-03,2022-01-14,2022-01-18,ACTUAL,,,,,,,2023-12-03,2023-12-08,ACTUAL,2022-03-24,ACTUAL,2022-03-24,2023-01,2023-01-31,2023-11-27,ACTUAL,2023-11-27,2023-11-27,ACTUAL,2023-11-27,,INTERVENTIONAL,,,A Clinical Trial to Evaluate Tolerability and Security of TQB2858 Injection in Subjects With Advanced Pancreatic Carcinoma,Phase I Clinical Trial to Evaluate the Tolerability and Safety of TQB2858 Injection in Subjects With Metastatic Pancreatic Cancer,TERMINATED,,PHASE1,29.0,ACTUAL,"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",,1.0,,Terminated due to the adjustment of sponsor's development strategies and pipeline.,f,,,,,f,f,,,,,,,,,,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,INDUSTRY,,,,,,,2023,0.0
NCT04846231,,2021-04-12,2023-04-18,,2023-05-24,2021-04-12,2021-04-15,ACTUAL,2023-05-24,2023-05-25,ACTUAL,,,,2023-05-24,2023-05-25,ACTUAL,2021-04-23,ACTUAL,2021-04-23,2023-05,2023-05-31,2022-07-19,ACTUAL,2022-07-19,2022-07-19,ACTUAL,2022-07-19,,INTERVENTIONAL,SPORT,,"Supplements, Placebo, or Rosuvastatin Study","Supplements, Placebo, or Rosuvastatin Study",COMPLETED,,PHASE2,203.0,ACTUAL,The Cleveland Clinic,,8.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:26:35.083762,2024-10-14 22:26:35.083762,OTHER,,,,,,,2022,1.0
NCT06084351,,2020-07-22,,,2023-10-12,2023-10-12,2023-10-16,ACTUAL,,,,,,,2023-10-12,2023-10-16,ACTUAL,2020-05-12,ACTUAL,2020-05-12,2023-10,2023-10-31,2020-10-30,ACTUAL,2020-10-30,2020-10-30,ACTUAL,2020-10-30,,INTERVENTIONAL,,,Phase 3 Open-Label Controlled Trial of Convalescent Plasma in Early COVID-19 Infection,Phase 3 Open-Label Controlled Trial of Convalescent Plasma in Early COVID-19 Infection,WITHDRAWN,,PHASE3,0.0,ACTUAL,Larkin Community Hospital,,2.0,,Study Period Ended / Not Completed,f,,,,f,t,f,,,,,,,,,,,2024-10-14 22:26:35.083762,2024-10-14 22:26:35.083762,OTHER,,,,,,,2020,0.0
NCT04168931,,2019-11-05,,,2023-01-13,2019-11-18,2019-11-19,ACTUAL,,,,,,,2023-01-13,2023-01-17,ACTUAL,2020-01-01,ACTUAL,2020-01-01,2023-01,2023-01-31,2023-01-13,ACTUAL,2023-01-13,2023-01-13,ACTUAL,2023-01-13,,INTERVENTIONAL,GASTHER2,,Trastuzumab to Patients With Advanced Gastric Cancer With HER2 Positive Expression in CTC,Efficacy of Adding Trastuzumab to Standard Chemotherapy in Patients With Advanced HER2-negative Gastric Cancer and HER2 Positive Expression in Circulating Tumor Cells,TERMINATED,,PHASE2,5.0,ACTUAL,AC Camargo Cancer Center,,1.0,,recruitment failure,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 22:26:35.083762,2024-10-14 22:26:35.083762,OTHER,,,,,,,2023,0.0
NCT03020589,,2017-01-11,2022-06-09,,2023-06-20,2017-01-11,2017-01-13,ESTIMATED,2022-07-18,2022-07-21,ACTUAL,,,,2023-06-20,2023-06-26,ACTUAL,2017-02-06,ACTUAL,2017-02-06,2022-07,2022-07-31,2022-06-28,ACTUAL,2022-06-28,2021-07-31,ACTUAL,2021-07-31,,INTERVENTIONAL,TAC3A5,,Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients,Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients,COMPLETED,,PHASE4,97.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,No participant data will be shared outside the research team.,2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,OTHER,,,,,,,2022,1.0
NCT06365918,,2024-04-10,,,2024-10-03,2024-04-12,2024-04-15,ACTUAL,,,,,,,2024-10-03,2024-10-08,ACTUAL,2024-09-30,ESTIMATED,2024-09-30,2024-10,2024-10-31,2024-10-02,ACTUAL,2024-10-02,2024-10-02,ACTUAL,2024-10-02,,INTERVENTIONAL,,,Study of VG2025 Delivered Intraperitoneally in Patients with Advanced Solid Tumors with Carcinomatosis,Phase I Study of VG2025 Delivered Intraperitoneally in Patients with Advanced Solid Tumors with Carcinomatosis,WITHDRAWN,,PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,PI Request,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,OTHER,,,,,,,2024,0.0
NCT03220347,,2017-07-14,,,2024-10-04,2017-07-14,2017-07-18,ACTUAL,,,,,,,2024-10-04,2024-10-08,ACTUAL,2017-07-24,ACTUAL,2017-07-24,2024-10,2024-10-31,2024-09-06,ACTUAL,2024-09-06,2024-09-06,ACTUAL,2024-09-06,,INTERVENTIONAL,,,"A Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-90010 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin's Lymphomas","A Phase 1, Open-label, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-90010 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin's Lymphomas",TERMINATED,,PHASE1,139.0,ACTUAL,Celgene,,1.0,,Business objectives have changed,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2024,0.0
NCT01427114,,2011-08-30,,,2021-05-03,2011-08-30,2011-09-01,ESTIMATED,,,,,,,2021-05-03,2021-05-06,ACTUAL,2011-07-01,ACTUAL,2011-07-01,2021-05,2021-05-31,2021-01-01,ACTUAL,2021-01-01,2014-08-01,ACTUAL,2014-08-01,,INTERVENTIONAL,,,R-CVP for the Treatment of Non-conjunctival Ocular Adnexal MALT Lymphoma (OAML),"Open-labeled, Multicenter Phase II Study of Rituximab, Cyclophosphamide, Vincristine, and Prednisolone (R-CVP) Chemotherapy in Patients With Non-conjunctival Ocular Adnexal MALT Lymphoma",COMPLETED,,PHASE2,33.0,ACTUAL,Konkuk University Medical Center,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 09:34:03.021488,2024-10-16 09:34:03.021488,OTHER,,,,,,,2021,1.0
NCT04707313,,2021-01-11,2024-09-12,,2024-09-12,2021-01-11,2021-01-13,ACTUAL,2024-09-12,2024-10-09,ACTUAL,,,,2024-09-12,2024-10-09,ACTUAL,2021-01-29,ACTUAL,2021-01-29,2024-09,2024-09-30,2023-10-11,ACTUAL,2023-10-11,2023-09-13,ACTUAL,2023-09-13,,INTERVENTIONAL,,Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.,A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity,"A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06882961 ADMINISTRATION IN ADULTS WITH OBESITY",COMPLETED,,PHASE2,628.0,ACTUAL,Pfizer,,13.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2023,1.0
NCT03766607,,2018-12-03,,,2019-09-17,2018-12-05,2018-12-06,ACTUAL,,,,,,,2019-09-17,2019-09-19,ACTUAL,2019-09-30,ESTIMATED,2019-09-30,2019-09,2019-09-30,2022-06-30,ESTIMATED,2022-06-30,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer,A Multi-center Phase II Study of Trastuzumab Biosimilar (SB3®) in Combination With Ramucirumab and Paclitaxel in HER2 Positive Metastatic Gastric Cancer Patients,WITHDRAWN,,PHASE2,0.0,ACTUAL,Korean South West Oncology Group,,1.0,,Competing other studies,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,NETWORK,,,,,,,2022,0.0
NCT05492851,,2022-08-04,,,2023-04-06,2022-08-05,2022-08-09,ACTUAL,,,,,,,2023-04-06,2023-04-10,ACTUAL,2022-08-02,ACTUAL,2022-08-02,2023-04,2023-04-30,2023-01-11,ACTUAL,2023-01-11,2023-01-11,ACTUAL,2023-01-11,,INTERVENTIONAL,,,Trial Comparing Three Single Dose Injections for Knee Osteoarthritis,"A Double-blind, Randomized Trial Comparing Three Single Dose Injections for Knee Osteoarthritis",TERMINATED,,PHASE4,6.0,ACTUAL,Ohio State University,,3.0,,The study has only enrolled 6 subjects in 6 months since study initiation. Potential participants are unwilling to participate in the study due to the randomziation and blinding. Both aspects are needed to ensure a robust comparison between groups.,f,,,,f,t,f,,,f,,,,,,NO,IDP will not be shared.,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,OTHER,,,,,,,2023,0.0
NCT04837482,,2021-04-06,2024-08-07,2022-11-07,2024-09-18,2021-04-07,2021-04-08,ACTUAL,2024-09-18,2024-10-10,ESTIMATED,,2024-10-10,ESTIMATED,2024-09-18,2024-10-10,ESTIMATED,2021-05-14,ACTUAL,2021-05-14,2024-09,2024-09-30,2021-12-07,ACTUAL,2021-12-07,2021-12-07,ACTUAL,2021-12-07,,INTERVENTIONAL,,The ITT population includes all randomized participants.,"A Study to Assess the Impact and Adverse Events of Topical Eyedrops of AGN-190584 on Night-driving Performance in Participants, 40 to 55 Years of Age",Evaluating the Impact of AGN-190584 on Night-driving Performance,COMPLETED,,PHASE3,43.0,ACTUAL,AbbVie,,2.0,,,f,,,,f,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2021,1.0
NCT04847141,,2021-04-14,2022-11-08,,2022-11-08,2021-04-14,2021-04-19,ACTUAL,2022-11-08,2022-12-05,ACTUAL,,,,2022-11-08,2022-12-05,ACTUAL,2021-04-28,ACTUAL,2021-04-28,2022-11,2022-11-30,2021-12-27,ACTUAL,2021-12-27,2021-11-10,ACTUAL,2021-11-10,,INTERVENTIONAL,COVID-19,Intent-to-treat (ITT) population included all participants who were randomized. Modified ITT (mITT) population included the subset of ITT participants who were also dosed.,A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients,"A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of Anti-COVID-19 Immune Globulin (Human) 20% (C19-IG 20%) Versus Placebo in Asymptomatic Ambulatory Outpatients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection",TERMINATED,,PHASE3,465.0,ACTUAL,Grifols Therapeutics LLC,The study was terminated for futility.,3.0,,Study Stopped for Futility,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,INDUSTRY,,,,,,,2021,0.0
NCT03879798,,2019-03-15,2024-04-26,,2024-10-08,2019-03-18,2019-03-19,ACTUAL,2024-10-08,2024-10-10,ESTIMATED,,,,2024-10-08,2024-10-10,ESTIMATED,2019-03-15,ACTUAL,2019-03-15,2024-10,2024-10-31,2023-05-02,ACTUAL,2023-05-02,2023-05-02,ACTUAL,2023-05-02,,INTERVENTIONAL,,"Participants were not treated at Dose Level 3, 4 or 5",DS-3201b and Irinotecan for Patients With Recurrent Small Cell Lung Cancer,"A Phase I/II Study of DS-3201b, an EZH1/2 Inhibitor, in Combination With Irinotecan in Patients With Recurrent Small Cell Lung Cancer",TERMINATED,,PHASE1/PHASE2,22.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,Due to DLTs,,,,,,t,f,,,,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,OTHER,,,,,,,2023,0.0
NCT04181762,,2019-11-27,2024-09-03,,2024-10-08,2019-11-27,2019-11-29,ACTUAL,2024-10-08,2024-10-10,ESTIMATED,,,,2024-10-08,2024-10-10,ESTIMATED,2020-07-07,ACTUAL,2020-07-07,2024-10,2024-10-31,2023-09-13,ACTUAL,2023-09-13,2023-09-13,ACTUAL,2023-09-13,,INTERVENTIONAL,SELUNE,,"Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis","A Two-year, Phase III Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Safety, Efficacy, and Tolerability of 300 mg s.c. Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis",TERMINATED,,PHASE3,275.0,ACTUAL,Novartis,,2.0,,Study terminated by sponsor due to futility analysis,f,,,,t,t,f,,,,,,,,,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2023,0.0
NCT05542355,,2022-09-02,,,2024-10-08,2022-09-13,2022-09-15,ACTUAL,,,,,,,2024-10-08,2024-10-10,ESTIMATED,2023-03-20,ACTUAL,2023-03-20,2024-10,2024-10-31,2024-10-02,ACTUAL,2024-10-02,2024-10-02,ACTUAL,2024-10-02,,INTERVENTIONAL,MAINTAIN,,EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease,"A Phase 1, Multicentre, 2-Part, Randomised, Parallel-arm, Placebo-controlled, Partially Double-blind Study to Evaluate the Safety and Target Engagement of EXL01 in the Maintenance of Steroid-induced Clinical Response or Remission in Participants With Mild to Moderate Crohn's Disease",TERMINATED,,PHASE1,8.0,ACTUAL,Exeliom Biosciences,,3.0,,Due to low recruitment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2024,0.0
NCT03893565,,2019-03-26,2022-02-10,,2022-03-30,2019-03-26,2019-03-28,ACTUAL,2022-03-30,2022-04-27,ACTUAL,,,,2022-03-30,2022-04-27,ACTUAL,2019-05-06,ACTUAL,2019-05-06,2022-03,2022-03-31,2021-05-17,ACTUAL,2021-05-17,2021-05-17,ACTUAL,2021-05-17,,INTERVENTIONAL,,,"Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis","A Multicentre Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety, Tolerability, Efficacy, Dose-response, Pharmacokinetics and Pharmacodynamics of Repeat Dosing of an Anti-LAG3 Cell Depleting Monoclonal Antibody (GSK2831781) in Patients With Active Ulcerative Colitis",TERMINATED,,PHASE2,104.0,ACTUAL,GlaxoSmithKline,,3.0,,The trial was stopped based on the assessment of clinical data.,f,,,,f,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2021,0.0
NCT04949425,,2021-06-25,,,2022-09-01,2021-06-25,2021-07-02,ACTUAL,,,,,,,2022-09-01,2022-09-02,ACTUAL,2021-09-13,ACTUAL,2021-09-13,2022-08,2022-08-31,2022-04-21,ACTUAL,2022-04-21,2022-04-21,ACTUAL,2022-04-21,,INTERVENTIONAL,,,A Study to Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours,"An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours Enrolled in Adavosertib Clinical Pharmacology Studies",TERMINATED,,PHASE1,3.0,ACTUAL,AstraZeneca,,1.0,,Study terminated because the clinical development programme for Adavosertib has been discontinued,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the~Disclosure Statements at:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,INDUSTRY,,,,,,,2022,0.0
NCT03398252,,2017-11-06,,,2022-08-29,2018-01-11,2018-01-12,ACTUAL,,,,,,,2022-08-29,2022-09-01,ACTUAL,2022-05-12,ESTIMATED,2022-05-12,2022-08,2022-08-31,2023-10-01,ESTIMATED,2023-10-01,2023-10-01,ESTIMATED,2023-10-01,,INTERVENTIONAL,,,Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL,Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL,WITHDRAWN,,PHASE1,0.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,No funding,f,,,,,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,OTHER,,,,,,,2023,0.0
NCT02651116,,2016-01-07,2021-03-03,,2021-04-26,2016-01-07,2016-01-08,ESTIMATED,2021-04-26,2021-04-28,ACTUAL,,,,2021-04-26,2021-04-28,ACTUAL,2016-02-25,ACTUAL,2016-02-25,2021-04,2021-04-30,2020-03-19,ACTUAL,2020-03-19,2020-03-19,ACTUAL,2020-03-19,,INTERVENTIONAL,CHPA DXM,The safety analysis set included all participants who received the study drug.,Dextromethorphan Pediatric Acute Cough Study,"A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP PILOT STUDY TO EVALUATE THE EFFICACY OF DEXTROMETHORPHAN HYDROBROMIDE ON ACUTE COUGH IN A PEDIATRIC POPULATION",TERMINATED,,PHASE4,131.0,ACTUAL,Pfizer,,2.0,,The study was prematurely discontinued due to slow enrollment during the 2019/2020 cold season. No safety or efficacy concerns led to the decision to terminate,f,,,,f,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-14 22:26:35.083762,2024-10-14 22:26:35.083762,INDUSTRY,,,,,,,2020,0.0
NCT03954834,,2019-05-15,2021-09-15,,2021-10-18,2019-05-16,2019-05-17,ACTUAL,2021-10-18,2021-10-20,ACTUAL,,,,2021-10-18,2021-10-20,ACTUAL,2019-06-03,ACTUAL,2019-06-03,2021-10,2021-10-31,2020-10-28,ACTUAL,2020-10-28,2020-10-05,ACTUAL,2020-10-05,,INTERVENTIONAL,SURPASS-1,All randomized participants.,A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone,"A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Three Tirzepatide Doses Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone",COMPLETED,,PHASE3,478.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://www.clinicalstudydatarequest.com,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2020,1.0
NCT03444376,,2018-01-25,,,2024-02-29,2018-02-19,2018-02-23,ACTUAL,,,,,,,2024-02-29,2024-03-01,ACTUAL,2018-06-19,ACTUAL,2018-06-19,2024-02,2024-02-29,2023-12-21,ACTUAL,2023-12-21,2022-04-29,ACTUAL,2022-04-29,,INTERVENTIONAL,,,The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer,"A Multi-Center, Open-label Phase Ib-II Trial of the Combination of GX-188E Vaccination and Pembrolizumab in Patients With Advanced, Non-Resectable HPV Type 16 and/or 18 Positive Cervical Cancer",COMPLETED,,PHASE1/PHASE2,65.0,ACTUAL,"Genexine, Inc.",,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 19:31:56.752951,2024-10-16 19:31:56.752951,INDUSTRY,,,,,,,2023,1.0
NCT00581477,,2007-12-22,2021-12-13,,2022-02-28,2007-12-22,2007-12-27,ESTIMATED,2022-02-28,2022-03-02,ACTUAL,,,,2022-02-28,2022-03-02,ACTUAL,2004-01,,2004-01-31,2022-02,2022-02-28,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Treatment of Orthostatic Hypotension,Treatment of Hypotensive Patients Having a Unique Pattern of Autonomic Symptoms,TERMINATED,,PHASE2/PHASE3,8.0,ACTUAL,Vanderbilt University Medical Center,,1.0,,1. enrollment slower than anticipated; 2. FDA approval of droxidopa so no longer need to treat patients on research basis; 3. personnel who were primarily responsible for the study are no longer at Vanderbilt.,f,,,,f,,,,,,,,,,,,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,OTHER,,,,,,,2020,0.0
NCT04154787,,2019-10-08,2024-01-17,,2024-10-07,2019-11-04,2019-11-06,ACTUAL,2024-06-11,2024-07-05,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2019-11-23,ACTUAL,2019-11-23,2024-10,2024-10-31,2023-01-20,ACTUAL,2023-01-20,2023-01-20,ACTUAL,2023-01-20,,INTERVENTIONAL,,,Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous Nephropathy,"A Randomized, Open-label, Two Arm, Parallel Group, Proof-of-concept Clinical Trial to Investigate the Efficacy and Safety of LNP023 Compared With Rituximab in the Treatment of Subjects With Idiopathic Membranous Nephropathy",TERMINATED,,PHASE2,37.0,ACTUAL,Novartis,"Per protocol, participants randomized to the former LNP023 low dose arm (LNP023 10/50 mg b.i.d.) were included in the safety and PK analyses but not in the PD/efficacy analyses as the low number of subjects would not have allowed for a meaningful analysis and interpretation of PD/efficacy data.",2.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 13:00:52.151471,2024-10-15 13:00:52.151471,INDUSTRY,,,,,,,2023,0.0
NCT02436226,,2015-05-02,,,2023-10-27,2015-05-05,2015-05-06,ESTIMATED,,,,,,,2023-10-27,2023-10-31,ACTUAL,2016-03,ACTUAL,2016-03-31,2023-10,2023-10-31,2023-01,ACTUAL,2023-01-31,2023-01,ACTUAL,2023-01-31,,INTERVENTIONAL,,,Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS,Use of Low Dose of Human Chorionic Gonadotropin During Ovulation Induction With Clomiphene Citrate in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome,COMPLETED,,PHASE4,300.0,ACTUAL,Mansoura University,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,OTHER,,,,,,,2023,1.0
NCT05141357,,2021-11-19,,,2023-11-08,2021-11-19,2021-12-02,ACTUAL,,,,,,,2023-11-08,2023-11-13,ACTUAL,2022-03-14,ACTUAL,2022-03-14,2023-11,2023-11-30,2023-04-19,ACTUAL,2023-04-19,2023-04-19,ACTUAL,2023-04-19,,INTERVENTIONAL,HBI-8000,,A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer,A Phase 2 Study to Assess the Safety and Efficacy of HBI-8000 in Combination With Pembrolizumab for Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC),TERMINATED,,PHASE2,5.0,ACTUAL,"HUYABIO International, LLC.",,1.0,,Slow Recruitment,f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,INDUSTRY,,,,,,,2023,0.0
NCT03597464,,2018-06-25,2022-09-26,,2022-11-17,2018-07-13,2018-07-24,ACTUAL,2022-11-17,2022-12-14,ACTUAL,,,,2022-11-17,2022-12-14,ACTUAL,2019-09-29,ACTUAL,2019-09-29,2022-11,2022-11-30,2021-10-07,ACTUAL,2021-10-07,2021-10-07,ACTUAL,2021-10-07,,INTERVENTIONAL,AURORA 2,"Intent-to-Treat is comprised of all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for subjects that continued in AURORA 2. Intent-to-Treat population was used for analysis of all Outcome Measures. Safety population comprised all randomized subjects who took at least one dose of study treatment, and was used for AE and SAE reporting.",Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin,"A Randomized, Controlled, Double-blind, Continuation Study Comparing the Long-term Safety and Efficacy of Voclosporin (23.7 mg Twice Daily) With Placebo in Subjects With Lupus Nephritis",COMPLETED,,PHASE3,216.0,ACTUAL,Aurinia Pharmaceuticals Inc.,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,INDUSTRY,,,,,,,2021,1.0
NCT02993406,,2016-12-09,2023-10-25,,2023-12-13,2016-12-12,2016-12-15,ESTIMATED,2023-12-13,2024-01-03,ACTUAL,,,,2023-12-13,2024-01-03,ACTUAL,2016-12-22,ACTUAL,2016-12-22,2023-12,2023-12-31,2022-11-07,ACTUAL,2022-11-07,2022-11-07,ACTUAL,2022-11-07,,INTERVENTIONAL,CLEAR Outcomes,Intention-to-Treat Population is defined as all randomized participants.,"Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo","A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant",COMPLETED,,PHASE3,13970.0,ACTUAL,"Esperion Therapeutics, Inc.",,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,INDUSTRY,,,,,,,2022,1.0
NCT04256174,,2020-02-03,,,2022-08-15,2020-02-03,2020-02-05,ACTUAL,,,,,,,2022-08-15,2022-08-17,ACTUAL,2020-06-15,ACTUAL,2020-06-15,2022-08,2022-08-31,2021-10-29,ACTUAL,2021-10-29,2021-10-29,ACTUAL,2021-10-29,,INTERVENTIONAL,,,A Study of AK120 (IL-4Rα) in Healthy Subjects and Subjects With Moderate- to- Severe Atopic Dermatitis,"A Phase 1, Randomized, Two-Part, Double-Blind, Placebo-Controlled, Dose-Escalation, Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AK120 in Healthy Subjects and Subjects With Moderate- to- Severe Atopic Dermatitis",COMPLETED,,PHASE1,80.0,ACTUAL,Akeso,,9.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 22:26:35.083762,2024-10-14 22:26:35.083762,INDUSTRY,,,,,,,2021,1.0
NCT05497284,,2022-08-05,,,2024-10-08,2022-08-10,2022-08-11,ACTUAL,,,,,,,2024-10-08,2024-10-10,ESTIMATED,2022-11-10,ACTUAL,2022-11-10,2024-10,2024-10-31,2024-09-26,ACTUAL,2024-09-26,2024-08-26,ACTUAL,2024-08-26,,INTERVENTIONAL,,,To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF,"A Participant- and Investigator-blinded, Randomized, Placebo-controlled, Multicenter, Platform Study to Investigate Efficacy, Safety, and Tolerability of Various Single Treatments in Participants With Idiopathic Pulmonary Fibrosis",TERMINATED,,PHASE2,46.0,ACTUAL,Novartis,,2.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,INDUSTRY,,,,,,,2024,0.0
NCT03008070,,2016-12-22,2021-03-16,,2023-07-18,2016-12-28,2017-01-02,ESTIMATED,2021-03-16,2021-04-12,ACTUAL,,,,2023-07-18,2023-07-19,ACTUAL,2017-02-07,ACTUAL,2017-02-07,2023-07,2023-07-31,2020-03-16,ACTUAL,2020-03-16,2020-02-20,ACTUAL,2020-02-20,,INTERVENTIONAL,NATIVE,,Phase 2b Study in NASH to Assess IVA337,"A Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-range, Proof-of-concept, 24-week Treatment Study of IVA337 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)",COMPLETED,,PHASE2,247.0,ACTUAL,Inventiva Pharma,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-14 22:32:10.753576,2024-10-14 22:32:10.753576,INDUSTRY,,,,,,,2020,1.0
NCT04655807,,2020-11-30,,,2021-08-30,2020-11-30,2020-12-07,ACTUAL,,,,,,,2021-08-30,2021-09-01,ACTUAL,2021-03-03,ESTIMATED,2021-03-03,2021-08,2021-08-31,2023-09-04,ESTIMATED,2023-09-04,2023-05-24,ESTIMATED,2023-05-24,,INTERVENTIONAL,DUET,,A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease,"A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy With Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants With Active Crohn's Disease",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,Sponsor Decision.,f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,INDUSTRY,,,,,,,2023,0.0
NCT03799003,,2019-01-02,,,2024-07-11,2019-01-09,2019-01-10,ACTUAL,,,,,,,2024-07-11,2024-07-15,ACTUAL,2019-01-14,ACTUAL,2019-01-14,2024-07,2024-07-31,2023-07-06,ACTUAL,2023-07-06,2023-07-06,ACTUAL,2023-07-06,,INTERVENTIONAL,,,A Study of ASP1951 in Subjects With Advanced Solid Tumors,"A Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,119.0,ACTUAL,Astellas Pharma Inc,,11.0,,Study was terminated for lack of efficacy.,f,,,,f,t,f,,,,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://www.clinicalstudydatarequest.com/,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-14 22:32:10.753576,2024-10-14 22:32:10.753576,INDUSTRY,,,,,,,2023,0.0
NCT05165732,,2021-12-20,,,2022-08-09,2021-12-20,2021-12-21,ACTUAL,,,,,,,2022-08-09,2022-08-11,ACTUAL,2022-12-20,ESTIMATED,2022-12-20,2021-11,2021-11-30,2023-08-20,ESTIMATED,2023-08-20,2023-03-20,ESTIMATED,2023-03-20,,INTERVENTIONAL,,,"Safety and Immunogenicity Study of Booster Vaccination With COVID-19 Vaccine (Vero Cell),Inactivated From Different Manufactures for Prevention of COVID-19","A Randomized, Open, Control Phase ⅠV Clinical Trial, to Evaluate One Booster Immunization of Inactivated COVID-19 Vaccine (CoronaVac) or Original Vaccine in Adults Aged 18-45 Years Old Previously Vaccinated With Inactivated COVID-19 Vaccine From Difference Manufactures",SUSPENDED,,PHASE4,480.0,ESTIMATED,"Sinovac Biotech Co., Ltd",,5.0,,Limited subjects,f,,,,f,f,f,,,,,,,,,,,2024-10-14 22:32:10.753576,2024-10-14 22:32:10.753576,INDUSTRY,,,,,,,2023,0.0
NCT03839940,,2019-02-06,2022-03-03,,2022-07-07,2019-02-12,2019-02-15,ACTUAL,2022-07-07,2022-08-01,ACTUAL,,,,2022-07-07,2022-08-01,ACTUAL,2019-02-15,ACTUAL,2019-02-15,2022-07,2022-07-31,2020-12-17,ACTUAL,2020-12-17,2020-12-17,ACTUAL,2020-12-17,,INTERVENTIONAL,MIST,,Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer,Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention Versus Early Treatment Approaches: MIST (My Individualized Stomatitis Treatment),TERMINATED,,PHASE3,39.0,ACTUAL,Alliance for Clinical Trials in Oncology,,2.0,,Severe lack of accrual,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,OTHER,,,,,,,2020,0.0
NCT04848480,,2021-04-16,,2023-04-26,2024-09-06,2021-04-16,2021-04-19,ACTUAL,,,,,2023-05-01,ACTUAL,2024-09-06,2024-09-19,ACTUAL,2021-04-30,ACTUAL,2021-04-30,2024-09,2024-09-30,2022-12-02,ACTUAL,2022-12-02,2022-04-28,ACTUAL,2022-04-28,,INTERVENTIONAL,ONWARDS 6,,"A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)","Efficacy and Safety of Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes. A 26-week, Randomised, Multicentre, Open-label, Active-controlled, Parallel Group, Two Armed, Treat-to-target Trial Investigating the Effect on Glycaemic Control and Safety of Treatment With Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec, Both in Combination With Insulin Aspart in Adults With Type 1 Diabetes, With a 26-week Extension Investigating Long Term Safety",COMPLETED,,PHASE3,582.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-14 22:32:10.753576,2024-10-14 22:32:10.753576,INDUSTRY,,,,,,,2022,1.0
NCT01865747,,2013-05-21,2017-04-21,,2021-04-01,2013-05-30,2013-05-31,ESTIMATED,2017-06-19,2017-07-18,ACTUAL,,,,2021-04-01,2021-04-27,ACTUAL,2013-06,,2013-06-30,2021-04,2021-04-30,2021-01-15,ACTUAL,2021-01-15,2015-05-22,ACTUAL,2015-05-22,,INTERVENTIONAL,METEOR,,A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma,"A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy",COMPLETED,,PHASE3,658.0,ACTUAL,Exelixis,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,INDUSTRY,,,,,,,2021,1.0
NCT03348735,,2017-11-16,,,2021-04-27,2017-11-20,2017-11-21,ACTUAL,,,,,,,2021-04-27,2021-04-28,ACTUAL,2018-12-03,ACTUAL,2018-12-03,2021-04,2021-04-30,2021-04-19,ACTUAL,2021-04-19,2021-04-19,ACTUAL,2021-04-19,,INTERVENTIONAL,PELICAN,,Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment,"Safety, Efficacy and Patient Acceptability of Topical Treatment Versus Systemic Treatment: a Randomized, Multicentre, Comparative Pragmatic Trial in Adult Patients Suffering From Diverse Localized Neuropathic Pain (LNP) Syndromes",TERMINATED,,PHASE4,33.0,ACTUAL,"University Hospital, Antwerp",,3.0,,Low inclusion rate,f,,,,,f,f,,,f,,,,,,UNDECIDED,,2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,OTHER,,,,,,,2021,0.0
NCT03714828,,2018-10-08,2024-07-16,,2024-10-01,2018-10-18,2018-10-22,ACTUAL,2024-10-01,2024-10-09,ACTUAL,,,,2024-10-01,2024-10-09,ACTUAL,2018-12-20,ACTUAL,2018-12-20,2024-10,2024-10-31,2023-07-19,ACTUAL,2023-07-19,2023-07-19,ACTUAL,2023-07-19,,INTERVENTIONAL,,,Study of TVEC in Patients With Cutaneous Squamous Cell Cancer,A Single Arm Phase 2 Study of Talimogene Laherparepvec in Patients With Cutaneous Squamous Cell Cancer,COMPLETED,,PHASE2,11.0,ACTUAL,University of Arizona,,1.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,OTHER,,,,,Target Injected Lesions,,2023,1.0
NCT03500874,,2018-04-08,,,2024-01-19,2018-04-16,2018-04-18,ACTUAL,,,,,,,2024-01-19,2024-01-22,ACTUAL,2018-05-28,ACTUAL,2018-05-28,2024-01,2024-01-31,2021-08-31,ACTUAL,2021-08-31,2021-08-31,ACTUAL,2021-08-31,,INTERVENTIONAL,,,Adjuvant Systemic Chemotherapy With or Without HAI-FUDR in Patients With Resected CRLM,Adjuvant Systemic Chemotherapy With or Without Hepatic Arterial Infusion Using Floxuridine in Patients Following Colorectal Cancer Liver Metastases Resection,TERMINATED,,PHASE3,92.0,ACTUAL,Sun Yat-sen University,,2.0,,The study was terminated prematurely due to FUDR production halt in China,f,,,,t,f,f,,,,,,,,,UNDECIDED,Study Protocol,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,OTHER,,,,,,,2021,0.0
NCT05243719,,2022-02-03,,,2024-03-22,2022-02-14,2022-02-17,ACTUAL,,,,,,,2024-03-22,2024-03-26,ACTUAL,2022-03-14,ACTUAL,2022-03-14,2024-03,2024-03-31,2024-02-27,ACTUAL,2024-02-27,2024-02-27,ACTUAL,2024-02-27,,INTERVENTIONAL,,,Open-label Extension Study of ADP101,An Open-Label Extension Study Evaluating the Safety and Efficacy of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Encore Study),TERMINATED,,PHASE1/PHASE2,45.0,ACTUAL,"Alladapt Immunotherapeutics, Inc.",,1.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,INDUSTRY,,,,,,,2024,0.0
NCT05879120,,2023-05-18,,,2024-10-03,2023-05-18,2023-05-30,ACTUAL,,,,,,,2024-10-03,2024-10-08,ACTUAL,2024-07-30,ACTUAL,2024-07-30,2024-10,2024-10-31,2024-10-02,ACTUAL,2024-10-02,2024-10-02,ACTUAL,2024-10-02,,INTERVENTIONAL,,,Randomized Study of Neo-adjuvant and Adjuvant Pembrolizumab with and Without Targeted Blood Brain Barrier Opening Using Exablate MRI-guided Focused Ultrasound (Exablate MRgFUS) for Recurrent Glioblastoma,Randomized Study of Neo-adjuvant and Adjuvant Pembrolizumab with and Without Targeted Blood Brain Barrier Opening Using Exablate MRI-guided Focused Ultrasound (Exablate MRgFUS) for Recurrent Glioblastoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,PI Request,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,OTHER,,,,,,,2024,0.0
NCT05084859,,2021-09-24,,,2024-08-07,2021-10-06,2021-10-20,ACTUAL,,,,,,,2024-08-07,2024-08-09,ACTUAL,2021-11-03,ACTUAL,2021-11-03,2024-08,2024-08-31,2022-10-20,ACTUAL,2022-10-20,2022-10-20,ACTUAL,2022-10-20,,INTERVENTIONAL,,,"A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors","A Phase 1b, Open-Label, Dose-Escalation, Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,30.0,ACTUAL,"Biosplice Therapeutics, Inc.",,3.0,,Study was terminated due business reasons by Sponsor.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,INDUSTRY,,,,,,,2022,0.0
NCT03901638,,2019-03-24,,,2023-04-05,2019-04-02,2019-04-03,ACTUAL,,,,,,,2023-04-05,2023-04-07,ACTUAL,2019-04-02,ACTUAL,2019-04-02,2020-04,2020-04-30,2023-04-03,ACTUAL,2023-04-03,2023-04-03,ACTUAL,2023-04-03,,INTERVENTIONAL,,,Tllsh2910 for Ataxia and Gut Microbiota Alteration in Patients of Multiple System Atrophy,"Gut Microbiota Alteration and Improvement of Ataxia in Patients of Multiple System Atrophy Treating With Tllsh2910 - a Randomized, Placebo-controlled, Double-blinded, Cross-over, Single-center Clinical Trial",TERMINATED,,PHASE3,18.0,ACTUAL,National Taiwan University Hospital,,2.0,,Project replanning,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 22:32:10.753576,2024-10-14 22:32:10.753576,OTHER,,,,,,,2023,0.0
NCT05019950,,2021-08-16,,,2023-06-06,2021-08-19,2021-08-25,ACTUAL,,,,,,,2023-06-06,2023-06-08,ACTUAL,2021-10-28,ACTUAL,2021-10-28,2023-06,2023-06-30,2022-04-28,ACTUAL,2022-04-28,2022-04-28,ACTUAL,2022-04-28,,INTERVENTIONAL,,,Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers,"A Randomized, Placebo-Controlled, Double-Blind, Single-Center Study to Evaluate Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers",COMPLETED,,PHASE1,56.0,ACTUAL,NImmune Biopharma,,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,INDUSTRY,,,,,,,2022,0.0
NCT02213289,,2014-08-01,2021-01-29,,2021-03-15,2014-08-08,2014-08-11,ESTIMATED,2021-03-15,2021-04-08,ACTUAL,,,,2021-03-15,2021-04-08,ACTUAL,2015-01-20,ACTUAL,2015-01-20,2021-03,2021-03-31,2020-08-20,ACTUAL,2020-08-20,2020-02-01,ACTUAL,2020-02-01,,INTERVENTIONAL,,,PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression,PANGEA: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma,COMPLETED,,PHASE2,80.0,ACTUAL,University of Chicago,,8.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,OTHER,,,,,,,2020,1.0
NCT03839823,,2019-01-24,2024-05-09,,2024-10-07,2019-02-11,2019-02-15,ACTUAL,2024-05-09,2024-09-20,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2019-02-25,ACTUAL,2019-02-25,2024-10,2024-10-31,2023-05-10,ACTUAL,2023-05-10,2022-04-12,ACTUAL,2022-04-12,,INTERVENTIONAL,RIGHT Choice,The full analysis set comprised all patients to whom study treatment was assigned by randomization.,Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer,A Phase II Randomized Study of the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Physician Choice Chemotherapy in Premenopausal or Perimenopausal Patients With Hormone Receptor-positive/ HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer,COMPLETED,,PHASE2,222.0,ACTUAL,Novartis,,2.0,,,f,,,,f,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,INDUSTRY,,,,,,,2023,1.0
NCT03338296,,2017-11-07,2021-03-30,,2021-06-29,2017-11-07,2017-11-09,ACTUAL,2021-06-29,2021-07-19,ACTUAL,,,,2021-06-29,2021-07-19,ACTUAL,2017-09-28,ACTUAL,2017-09-28,2021-05,2021-05-31,2020-04-03,ACTUAL,2020-04-03,2020-04-03,ACTUAL,2020-04-03,,INTERVENTIONAL,,The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.,"Study to Evaluate the Efficacy and Safety of Belviq XR® in Conjunction With Lifestyle Modification for Weight Loss in Obese Adolescents, Age 12 to 17 Years","A 52 Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Belviq XR® in Conjunction With Lifestyle Modification for Weight Loss in Obese Adolescents, Age 12 to 17 Years",TERMINATED,,PHASE4,278.0,ACTUAL,Eisai Inc.,This study was terminated as Eisai agreed to voluntarily withdraw Belviq extended release (XR) from the United States market after a request from the Food and Drug Administration based on the Agency's analysis of data from the CAMELIA-TIMI 61 cardiovascular outcomes study (NCT02019264).,2.0,,Study was terminated as Eisai agreed to voluntarily withdraw Belviq XR from US market.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,INDUSTRY,,,,,,,2020,0.0
NCT04558918,,2020-08-27,2023-09-19,,2024-10-07,2020-09-16,2020-09-22,ACTUAL,2023-11-03,2023-11-28,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2021-01-25,ACTUAL,2021-01-25,2024-10,2024-10-31,2023-03-06,ACTUAL,2023-03-06,2022-09-26,ACTUAL,2022-09-26,,INTERVENTIONAL,APPLY-PNH,,Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment,"A Randomized, Multicenter, Active-comparator Controlled, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily LNP023 in Adult Patients With PNH and Residual Anemia, Despite Treatment With an Intravenous Anti-C5 Antibody.",COMPLETED,,PHASE3,97.0,ACTUAL,Novartis,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,INDUSTRY,,,,,,,2023,1.0
NCT04629196,,2020-11-10,,,2024-02-27,2020-11-10,2020-11-16,ACTUAL,,,,,,,2024-02-27,2024-02-29,ACTUAL,2022-02-16,ACTUAL,2022-02-16,2024-02,2024-02-29,2024-01-17,ACTUAL,2024-01-17,2024-01-17,ACTUAL,2024-01-17,,INTERVENTIONAL,,,Induction Optimization With Stelara for Crohn's Disease,Induction Optimization With Stelara for Crohn's Disease,TERMINATED,,PHASE4,25.0,ACTUAL,NYU Langone Health,,2.0,,Other effective drugs have been introduced to market since the beginning of the study.,f,,,,f,t,f,,,t,,,Data will become available beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research,"The investigator who proposed to use the data upon reasonable request. Requests should be directed to IBD_Research@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.",,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.",2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,OTHER,,,,,,,2024,0.0
NCT04434300,,2020-04-29,,,2022-01-31,2020-06-15,2020-06-16,ACTUAL,,,,,,,2022-01-31,2022-02-01,ACTUAL,2020-10-15,ACTUAL,2020-10-15,2021-07,2021-07-31,2021-11-15,ACTUAL,2021-11-15,2021-01-15,ACTUAL,2021-01-15,,INTERVENTIONAL,DAPTOSC,,Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC),Comparison of the Pharmacokinetic and the Safety of Daptomycin Administered Subcutaneously Compared to the Intravenous Route : a Cross-over Study,COMPLETED,,PHASE1,12.0,ACTUAL,"University Hospital, Caen",,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,OTHER,,,,,,,2021,1.0
NCT02702492,,2016-03-03,,,2023-01-18,2016-03-03,2016-03-08,ESTIMATED,,,,,,,2023-01-18,2023-01-19,ACTUAL,2016-06,ACTUAL,2016-06-30,2023-01,2023-01-31,2021-06-01,ACTUAL,2021-06-01,2021-02-01,ACTUAL,2021-02-01,,INTERVENTIONAL,PANAMA,,PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA),"A Phase 1 Open-Label Study of the Safety, Tolerability and Efficacy of KPT-9274, a Dual Inhibitor of PAK4 and NAMPT, in Patients With Advanced Solid Malignancies or Non-Hodgkin's Lymphoma",TERMINATED,,PHASE1,60.0,ACTUAL,Karyopharm Therapeutics Inc,,3.0,,sponsor decision,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,INDUSTRY,,,,,,,2021,0.0
NCT02709512,,2016-03-05,2023-08-02,,2023-09-09,2016-03-10,2016-03-16,ESTIMATED,2023-09-09,2023-10-04,ACTUAL,,,,2023-09-09,2023-10-04,ACTUAL,2017-08-01,ACTUAL,2017-08-01,2023-08,2023-08-31,2022-08-15,ACTUAL,2022-08-15,2022-08-15,ACTUAL,2022-08-15,,INTERVENTIONAL,ATOMIC,,Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin,"Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesotheliomato Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)",COMPLETED,,PHASE2/PHASE3,249.0,ACTUAL,Polaris Group,Enrollment stopped early at the recommendation of the DSMB due to interim analysis positive results and because of slow study enrollment related to an evolving treatment landscape for MPM and the COVID-19 pandemic.,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-14 22:32:10.753576,2024-10-14 22:32:10.753576,INDUSTRY,,,,,,,2022,1.0
NCT04830943,,2020-12-24,,,2022-12-29,2021-04-01,2021-04-05,ACTUAL,,,,,,,2022-12-29,2023-01-03,ACTUAL,2020-08-01,ACTUAL,2020-08-01,2022-12,2022-12-31,2022-10-30,ACTUAL,2022-10-30,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,,,Cerebrolycin for Treatment of Covid-related Anosmia and Ageusia,"The Effectiveness of Cerebrolycin, a Multi-modal Neurotrophic Factor, for Treatment of Post-covid-19 Persistent Olfactory, Gustatory and Trigeminal Chemosensory Dysfunctions: A Pilot Study",COMPLETED,,PHASE3,250.0,ACTUAL,Assiut University,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 22:32:10.753576,2024-10-14 22:32:10.753576,OTHER,,,,,,,2022,1.0
NCT03710889,,2018-10-15,2021-09-05,,2021-10-12,2018-10-17,2018-10-18,ACTUAL,2021-10-12,2021-10-15,ACTUAL,,,,2021-10-12,2021-10-15,ACTUAL,2018-09-20,ACTUAL,2018-09-20,2021-10,2021-10-31,2020-07-15,ACTUAL,2020-07-15,2020-07-15,ACTUAL,2020-07-15,,INTERVENTIONAL,,,Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption,"An Open-Label, Single-Arm, Multicenter Study to Evaluate the Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption",COMPLETED,,PHASE3,23.0,ACTUAL,"Radius Health, Inc.",,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:32:10.753576,2024-10-14 22:32:10.753576,INDUSTRY,,,,,,,2020,1.0
NCT02882308,,2016-07-20,,,2020-02-06,2016-08-26,2016-08-29,ESTIMATED,,,,,,,2020-02-06,2020-02-07,ACTUAL,2016-10-20,ACTUAL,2016-10-20,2020-02,2020-02-29,2020-01-10,ACTUAL,2020-01-10,2019-12,ACTUAL,2019-12-31,,INTERVENTIONAL,OPHELIA,,Preoperative Administration of Olaparib With Cisplatin or With Durvalumab or Alone or no Tratment in Patients Who Are Candidates for Surgery of Carcinoma of the Head and Neck.,Phase II(Window) Preoperative Study of Olaparib With Cisplatin or With Durvalumab (MEDI4736) or Alone or no Treatment in Patients With Histologically Proven Squamous Cell Carcinoma of the Head and Neck Who Are Candidates for Surgery.,COMPLETED,,PHASE2,41.0,ACTUAL,Hellenic Cooperative Oncology Group,,4.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,OTHER,,,,,,,2020,1.0
NCT03203850,,2017-06-22,2024-04-10,,2024-10-07,2017-06-28,2017-06-29,ACTUAL,2024-06-06,2024-06-07,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2018-01-11,ACTUAL,2018-01-11,2024-05,2024-05-31,2023-04-17,ACTUAL,2023-04-17,2023-04-17,ACTUAL,2023-04-17,,INTERVENTIONAL,,,Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis (HH),"A Phase II, Multicenter, Open-label, Randomized Two-year Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis.",TERMINATED,,PHASE2,45.0,ACTUAL,Novartis,The results should be interpreted with caution due to low number of participants enrolled in both arms.,2.0,,Due to enrolment challenge,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,INDUSTRY,,,,,,,2023,0.0
NCT03861598,,2019-02-11,,,2021-09-17,2019-03-01,2019-03-04,ACTUAL,,,,,,,2021-09-17,2021-09-24,ACTUAL,2019-07-19,ACTUAL,2019-07-19,2021-09,2021-09-30,2021-06-17,ACTUAL,2021-06-17,2020-08-21,ACTUAL,2020-08-21,,INTERVENTIONAL,,,Carvedilol With Chemotherapy in Second Line Glioblastoma and Response of Circulating Tumor Cells,A Feasibility Study: Evaluating Carvedilol With Chemotherapy in Second Line Glioblastoma Multiforme and Response of Peripheral Glioma Circulating Tumor Cells,TERMINATED,,EARLY_PHASE1,4.0,ACTUAL,West Virginia University,,1.0,,Due to Covid,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,OTHER,,,,,,,2021,0.0
NCT03166761,,2017-05-16,2024-02-26,,2024-07-03,2017-05-24,2017-05-25,ACTUAL,2024-07-03,2024-07-10,ACTUAL,,,,2024-07-03,2024-07-10,ACTUAL,2017-09-14,ACTUAL,2017-09-14,2024-07,2024-07-31,2023-02-28,ACTUAL,2023-02-28,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,,the other 18 patients with a negative diagnostic response were not included in the study after the negative screen,Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Injection,Randomized Prospective Study of Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Steroid Injection,TERMINATED,,PHASE4,41.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,recruitment and staffing,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,OTHER,,,,,,,2023,0.0
NCT04642638,,2020-11-23,2023-10-16,2023-09-12,2023-11-29,2020-11-23,2020-11-24,ACTUAL,2023-11-29,2023-12-20,ACTUAL,,2023-12-20,ACTUAL,2023-11-29,2023-12-20,ACTUAL,2020-11-30,ACTUAL,2020-11-30,2023-11,2023-11-30,2022-09-13,ACTUAL,2022-09-13,2022-09-13,ACTUAL,2022-09-13,,INTERVENTIONAL,,ITT population included all participants who were randomized.,"Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure","Phase 2/3 Randomized, Blinded, Placebo-Controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of INO-4800, a Prophylactic Vaccine Against COVID-19 Disease, Administered Intradermally Followed by Electroporation in Adults at High Risk of SARS-CoV-2 Exposure",TERMINATED,,PHASE2/PHASE3,1307.0,ACTUAL,Inovio Pharmaceuticals,,6.0,,The study was terminated to prioritize Inovio's COVID-19 efforts to advance a heterologous booster strategy and optimize potential impact on global public health.,f,,,,t,t,t,t,,,,,Anonymous IPD may be shared following or during the publication of summary data. Archival data may be accessed for up to 10 years following the end of the study.,Those who request the anonymous IPD must provide a plan of study explaining how the data will be used. Requests may be sent to the Central Contact Person. Requests will be reviewed based on the potential for the planned use of the IPD for advancing scientific knowledge and theory.,,YES,Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,INDUSTRY,,,,,,,2022,0.0
NCT04240886,,2020-01-22,2023-03-29,,2024-05-16,2020-01-23,2020-01-27,ACTUAL,2023-05-12,2023-05-19,ACTUAL,,,,2024-05-16,2024-06-03,ACTUAL,2020-01-04,ACTUAL,2020-01-04,2024-05,2024-05-31,2022-05-09,ACTUAL,2022-05-09,2022-03-29,ACTUAL,2022-03-29,,INTERVENTIONAL,AEGIS,Safety population included all participants who received at least 1 dose of study drug.,Open-label Study of APX001 for Treatment of Patients With Invasive Mold Infections Caused by Aspergillus or Rare Molds,"A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of APX001 in the Treatment of Patients With Invasive Mold Infections Caused by Aspergillus Species or Rare Molds",TERMINATED,,PHASE2,21.0,ACTUAL,Basilea Pharmaceutica,,2.0,,"The Sponsor made a strategic decision to terminate the study, in order to prioritize a randomized comparative Phase 3 trial in the same indication. This decision was not based on any safety concerns",f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 22:32:10.753576,2024-10-14 22:32:10.753576,INDUSTRY,,,,,,,2022,0.0
NCT00948324,,2009-07-28,,,2017-10-01,2009-07-28,2009-07-29,ESTIMATED,,,,,,,2017-10-01,2017-10-03,ACTUAL,2008-06,,2008-06-30,2017-10,2017-10-31,2021-12,ESTIMATED,2021-12-31,2019-05,ESTIMATED,2019-05-31,,INTERVENTIONAL,,,Effect of Intensive Therapy Associated With CSII on β-cell Function With Newly Diagnosed Type 2 Diabetes,Effect of Intensive Therapy Associated With CSII on β-cell Function With Newly Diagnosed Type 2 Diabetes,SUSPENDED,,PHASE4,400.0,ESTIMATED,Sun Yat-sen University,,4.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,OTHER,,,,,,,2021,0.0
NCT03426137,,2018-01-16,2020-02-24,,2021-04-26,2018-02-01,2018-02-08,ACTUAL,2020-03-06,2020-03-16,ACTUAL,,,,2021-04-26,2021-04-27,ACTUAL,2018-09-17,ACTUAL,2018-09-17,2021-04,2021-04-30,2020-01-21,ACTUAL,2020-01-21,2019-03-30,ACTUAL,2019-03-30,,INTERVENTIONAL,,The three participants who gave written consent to participate in the study and signed the HIPAA form withdrew before randomization or starting any study procedures. Therefore there is no data available to report.,Relieving Acute Pain (RAP) Study: A Pilot Study,Relieving Acute Pain (RAP): A Pilot Study,TERMINATED,,PHASE2,3.0,ACTUAL,"University of Maryland, Baltimore","Early termination due to logistical and funding issues, which lead to no analyzable data. A protocol paper has been published should other investigators wish to use the study design (DOI: 10.1136/bmjopen-2019-030623).",3.0,,The focus of the project has shifted to publishing a protocol for future trials because we were unable to recruit. Three participants signed the consent forms but withdrew before the randomization.,f,,,,t,t,f,,,t,,,,,,NO,IPD will only be shared among study team members.,2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,OTHER,,,,,,,2020,0.0
NCT04807400,,2021-03-17,2024-01-11,,2024-10-07,2021-03-17,2021-03-19,ACTUAL,2024-02-27,2024-03-25,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2021-07-07,ACTUAL,2021-07-07,2024-10,2024-10-31,2023-01-13,ACTUAL,2023-01-13,2023-01-13,ACTUAL,2023-01-13,,INTERVENTIONAL,SPIRIT,"Baseline Participants are based on the Full Analysis Set (FAS) population, as primary and secondary analysis are based on the FAS",Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support,"A Phase IIIb, Multicentre, Randomised Controlled Study to Evaluate the Implementation, Preference and Utility for Administration of Inclisiran Sodium in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD-risk Equivalents and Elevated Low Density Lipoprotein Cholesterol (LDL-C) Using a Primary Care Models in the NHS.",COMPLETED,,PHASE3,892.0,ACTUAL,Novartis,,3.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,INDUSTRY,,,,,,,2023,1.0
NCT03713632,,2018-10-18,2023-07-12,2021-07-13,2024-10-07,2018-10-19,2018-10-22,ACTUAL,2023-07-12,2023-08-02,ACTUAL,2021-07-13,2021-07-16,ACTUAL,2024-10-07,2024-10-09,ACTUAL,2019-02-25,ACTUAL,2019-02-25,2024-10,2024-10-31,2022-07-19,ACTUAL,2022-07-19,2021-09-23,ACTUAL,2021-09-23,,INTERVENTIONAL,SUNRISE,Full Analysis Set (FAS),Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS),"A Randomized, Double-blind, Multicenter Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNRISE)",COMPLETED,,PHASE3,545.0,ACTUAL,Novartis,,4.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,INDUSTRY,,,,,,,2022,1.0
NCT02499627,,2015-07-14,,,2021-05-26,2015-07-14,2015-07-16,ESTIMATED,,,,,,,2021-05-26,2021-05-27,ACTUAL,2015-12-23,ACTUAL,2015-12-23,2020-09,2020-09-30,2020-06-30,ACTUAL,2020-06-30,2019-09-13,ACTUAL,2019-09-13,,INTERVENTIONAL,FIL-BBV,,Bendamustine Plus Brentuximab Vedotin in HL and CD30+ PTCL in First Salvage Setting,A Phase II Study With Bendamustine Plus Brentuximab Vedotin in Hodgkin's Lymphoma and CD30+ Peripheral T-cell Lymphoma in First Salvage Setting: the BBV Regimen.,TERMINATED,,PHASE2,43.0,ACTUAL,Fondazione Italiana Linfomi - ETS,,1.0,,expected accrual not reached,f,,,,f,,,,,,,,,,,,,2024-10-14 22:32:10.753576,2024-10-14 22:32:10.753576,OTHER,,,,,,,2020,0.0
NCT04916470,,2021-06-01,,2024-10-08,2024-10-08,2021-06-01,2021-06-07,ACTUAL,,,,,2024-03-15,ACTUAL,2024-10-08,2024-10-09,ACTUAL,2021-06-15,ACTUAL,2021-06-15,2024-10,2024-10-31,2023-10-11,ACTUAL,2023-10-11,2023-10-11,ACTUAL,2023-10-11,,INTERVENTIONAL,STEP HFpEF DM,,"Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes","Effect of Semaglutide 2.4 mg Once-weekly on Function and Symptoms in Subjects With Obesity-related Heart Failure With Preserved Ejection Fraction, and Type 2 Diabetes",COMPLETED,,PHASE3,617.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,INDUSTRY,,,,,,,2023,1.0
NCT04683029,,2020-12-22,2024-05-14,,2024-10-03,2020-12-22,2020-12-24,ACTUAL,2024-10-03,2024-10-09,ACTUAL,,,,2024-10-03,2024-10-09,ACTUAL,2021-02-24,ACTUAL,2021-02-24,2024-10,2024-10-31,2024-07-09,ACTUAL,2024-07-09,2023-05-17,ACTUAL,2023-05-17,,INTERVENTIONAL,,,A Study of Guselkumab in Participants With Systemic Sclerosis,"A Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Guselkumab in Participants With Systemic Sclerosis",COMPLETED,,PHASE2,56.0,ACTUAL,Janssen Pharmaceutical K.K.,,2.0,,,f,,,,f,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,INDUSTRY,,,,,,,2024,1.0
NCT05321524,,2022-03-18,,,2023-03-24,2022-04-04,2022-04-11,ACTUAL,,,,,,,2023-03-24,2023-03-28,ACTUAL,2015-07-01,ACTUAL,2015-07-01,2023-03,2023-03-31,2023-03-09,ACTUAL,2023-03-09,2023-03-09,ACTUAL,2023-03-09,,INTERVENTIONAL,CARE,,Obeticholic Acid in Pediatric Subjects With Biliary Atresia,"A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study, With an Optional Open-Label Extension to Assess the Safety, Tolerability, and Pharmacokinetics of Obeticholic Acid in Pediatric Subjects With Biliary Atresia",TERMINATED,,PHASE2,7.0,ACTUAL,Intercept Pharmaceuticals,,3.0,,"After extensive efforts to improve recruitment, it is deemed not feasible to enroll the requisite number of subjects to generate data needed to meet the study objectives. EMA Paediatric Committee agreed with the Sponsor to terminate this study.",f,,,,t,f,f,,,f,,,,,,,,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,INDUSTRY,,,,,,,2023,0.0
NCT05557942,,2022-09-15,2024-09-06,,2024-10-09,2022-09-23,2022-09-28,ACTUAL,2024-10-09,2024-10-10,ESTIMATED,,,,2024-10-09,2024-10-10,ESTIMATED,2022-11-02,ACTUAL,2022-11-02,2024-10,2024-10-31,2024-08-08,ACTUAL,2024-08-08,2024-08-08,ACTUAL,2024-08-08,,INTERVENTIONAL,IMPAHCT-FUL,The Intent-to-treat (ITT) analysis set included all randomized participants.,Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL),"A Long-Term Extension, Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension (PAH) Who Have Completed Study AV-101-002 (IMPAHCT-FUL)",TERMINATED,,PHASE3,186.0,ACTUAL,Aerovate Therapeutics,,6.0,,"Results from the parent study (IMPAHCT) demonstrated that while inhaled imatinib was well tolerated, it did not prove to be efficacious at any of the doses of AV-101 evaluated in the study.",f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,INDUSTRY,,,,,,,2024,0.0
NCT03547037,,2018-05-24,,,2022-11-03,2018-05-24,2018-06-06,ACTUAL,,,,,,,2022-11-03,2022-11-07,ACTUAL,2018-08-31,ACTUAL,2018-08-31,2022-11,2022-11-30,2022-07-04,ACTUAL,2022-07-04,2022-07-04,ACTUAL,2022-07-04,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-Programmed Cell Death (PD)-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Participants With Advanced Solid Cancers","A Phase 1/1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Subjects With Advanced Solid Cancers",COMPLETED,,PHASE1,22.0,ACTUAL,Janssen Pharmaceutical K.K.,,2.0,,,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,INDUSTRY,,,,,,,2022,0.0
NCT03892772,,2019-03-26,,,2022-02-28,2019-03-26,2019-03-27,ACTUAL,,,,,,,2022-02-28,2022-03-02,ACTUAL,2019-01-14,ACTUAL,2019-01-14,2022-02,2022-02-28,2021-07-03,ACTUAL,2021-07-03,2021-07-03,ACTUAL,2021-07-03,,INTERVENTIONAL,ComboPlus,,Combination Pharmacological Interventions for Multiple Mechanisms of Obstructive Sleep Apnea,Combination Pharmacological Interventions for Multiple Mechanisms of Obstructive Sleep Apnea,COMPLETED,,PHASE1/PHASE2,23.0,ACTUAL,Brigham and Women's Hospital,,4.0,,,f,,,,f,t,f,,,t,,,Immediately after publication. No end date.,"1-page proposals should be directed to Dr. Scott Sands (sasands@bwh.harvard.edu). To gain access, requestors will be asked to sign a data use agreement.",,YES,"Will IPD be available? Yes What data will be shared? All IPD collected during the study, after deidentification.~When will data be available? Immediately after publication. No end date. With whom? Researchers who provide a methodologically sound proposal. For what types of analyses? Any purpose.",2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,OTHER,,,,,,,2021,0.0
NCT04389840,,2020-05-13,2022-05-27,,2022-08-08,2020-05-13,2020-05-15,ACTUAL,2022-08-08,2022-08-30,ACTUAL,,,,2022-08-08,2022-08-30,ACTUAL,2020-07-08,ACTUAL,2020-07-08,2022-08,2022-08-31,2021-05-20,ACTUAL,2021-05-20,2021-05-20,ACTUAL,2021-05-20,,INTERVENTIONAL,,"Note: Baseline characteristics were evaluated for the Safety Analysis Set. The Intent-to-Treat Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.",Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure,A Phase 2/3 Study to Evaluate the Safety and Efficacy of Dociparstat Sodium for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure,TERMINATED,,PHASE2/PHASE3,27.0,ACTUAL,Chimerix,"Due to improvement in the Coronavirus Disease 2019 (COVID-19) pandemic and low subject accrual, study enrollment was prematurely terminated on 20 May 2021. Therefore, formal statistical analyses were not performed, and no conclusions can be drawn about docipartstat with regards to efficacy.",6.0,,Due to improvement in the Coronavirus Disease 2019 (COVID-19) pandemic and low subject accrual.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,INDUSTRY,,,,,,,2021,0.0
NCT04268069,,2020-02-11,,,2020-11-12,2020-02-11,2020-02-13,ACTUAL,,,,,,,2020-11-12,2020-11-13,ACTUAL,2020-02-14,ACTUAL,2020-02-14,2020-11,2020-11-30,2020-10-05,ACTUAL,2020-10-05,2020-10-05,ACTUAL,2020-10-05,,INTERVENTIONAL,,,Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye,"A Phase 2, Multi-center, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of PL9643 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye",COMPLETED,,PHASE2,160.0,ACTUAL,"ORA, Inc.",,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-14 22:32:10.753576,2024-10-14 22:32:10.753576,INDUSTRY,,,,,,,2020,0.0
NCT04812535,,2021-03-10,,,2024-06-28,2021-03-21,2021-03-23,ACTUAL,,,,,,,2024-06-28,2024-07-01,ACTUAL,2021-06-01,ACTUAL,2021-06-01,2024-06,2024-06-30,2024-06-04,ACTUAL,2024-06-04,2024-06-04,ACTUAL,2024-06-04,,INTERVENTIONAL,,,Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.,"Open Label, Multicenter Phase II Study of the C5a Antibody IFX-1 Alone or IFX-1 + Pembrolizumab in Patients With PD-1 or PD-L1 Resistant/Refractory Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC)",TERMINATED,,PHASE2,25.0,ACTUAL,InflaRx GmbH,,2.0,,Sponsor decided to stop the development of vilobelimab in cSCC and early terminates the IFX-1-P2.8 trial due to new alternative treatments for cSCC with high efficacy rates.,f,,,,f,t,f,,,,,,,,,,,2024-10-14 22:32:10.753576,2024-10-14 22:32:10.753576,INDUSTRY,,,,,,,2024,0.0
NCT02165813,,2014-06-09,,,2024-02-06,2014-06-12,2014-06-18,ESTIMATED,,,,,,,2024-02-06,2024-02-08,ACTUAL,2014-11,ACTUAL,2014-11-30,2024-02,2024-02-29,2021-06-06,ACTUAL,2021-06-06,2021-04-21,ACTUAL,2021-04-21,,INTERVENTIONAL,NICEGUT,,Oral Nitazoxanide in Acute Gastroenteritis in Australian Indigenous Children,"A Randomised, Placebo-controlled Trial of Oral Nitazoxanide for the Empiric Treatment of Acute Gastroenteritis Among Australian Indigenous Children",TERMINATED,,PHASE2/PHASE3,216.0,ACTUAL,Telethon Kids Institute,,2.0,,Continuation of enrolment was deemed not feasible due to very small eligibility numbers and funding exhausted.,f,,,,t,,,,,,,,,,,,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,OTHER,,,,,,,2021,0.0
NCT04323436,,2020-03-23,2023-11-30,,2024-10-07,2020-03-24,2020-03-26,ACTUAL,2024-01-11,2024-02-06,ACTUAL,,,,2024-10-07,2024-10-09,ACTUAL,2020-08-19,ACTUAL,2020-08-19,2024-10,2024-10-31,2023-01-26,ACTUAL,2023-01-26,2022-12-14,ACTUAL,2022-12-14,,INTERVENTIONAL,,All patients to whom study treatment had been assigned and who received at least one dose of study treatment (i.e. at least one dose of any component of the study treatment that is capmatinib or spartalizumab). The randomized part of the study was not initiated.,Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations,"A Double-blind, Placebo Controlled, Randomized, Phase II Study Evaluating the Efficacy and Safety of Capmatinib and Spartalizumab vs Capmatinib and Placebo as 1st Line Treatment for Advanced NSCLC Patients With MET exon14 Skipping Mutations",TERMINATED,,PHASE2,31.0,ACTUAL,Novartis,,3.0,,Study termination based on sponsor decision due to lack of tolerability observed with capmatinib and spartalizumab combination treatment when compared to data from capmatinib single agent studies,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,INDUSTRY,,,,,,,2023,0.0
NCT03690869,,2018-09-17,2024-05-07,,2024-10-01,2018-09-28,2018-10-01,ACTUAL,2024-10-01,2024-10-09,ACTUAL,,,,2024-10-01,2024-10-09,ACTUAL,2018-09-24,ACTUAL,2018-09-24,2024-10,2024-10-31,2023-05-10,ACTUAL,2023-05-10,2023-05-10,ACTUAL,2023-05-10,,INTERVENTIONAL,,,"REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma","A Safety and Pharmacokinetic Study of Single Agent REGN2810 in Pediatric Patients With Relapsed or Refractory Solid or Central Nervous System (CNS) Tumors and a Safety and Efficacy Trial of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma, Newly Diagnosed High-Grade Glioma, or Recurrent High-Grade Glioma",TERMINATED,,PHASE1/PHASE2,57.0,ACTUAL,Regeneron Pharmaceuticals,"As all efficacy cohorts for this study have now been closed due to the futility criteria, Regeneron as Sponsor in collaboration with PNOC made a decision to close the study to further enrollment.",4.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,INDUSTRY,,,,,,,2023,0.0
NCT04635527,,2020-11-13,,,2023-03-14,2020-11-18,2020-11-19,ACTUAL,,,,,,,2023-03-14,2023-03-16,ACTUAL,2020-12-24,ACTUAL,2020-12-24,2023-03,2023-03-31,2023-03-07,ACTUAL,2023-03-07,2021-08-27,ACTUAL,2021-08-27,,INTERVENTIONAL,,,A Study on the Safety and Effectiveness of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma,A Phase Ib Study to Evaluate the Safety and Efficacy of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma,TERMINATED,,PHASE1,10.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,2.0,,Due to the company's development strategy adjustment ，Innovent Bioligics decided not to continue the study after consultation with investigators.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,INDUSTRY,,,,,,,2023,0.0
NCT03738423,,2018-11-08,2021-12-15,2021-03-12,2022-05-16,2018-11-08,2018-11-13,ACTUAL,2022-05-16,2022-06-10,ACTUAL,2022-05-16,2022-06-10,ACTUAL,2022-05-16,2022-06-10,ACTUAL,2018-11-13,ACTUAL,2018-11-13,2022-05,2022-05-31,2020-07-24,ACTUAL,2020-07-24,2020-03-13,ACTUAL,2020-03-13,,INTERVENTIONAL,,Full Analysis Set (FAS) included all randomized participants and was based on the treatment allocated (as randomized).,"Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis","A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to- Severe Atopic Dermatitis",TERMINATED,,PHASE2,129.0,ACTUAL,Regeneron Pharmaceuticals,"The decision was made by the sponsor to terminate the study on 12 Feb 2020 due to lack of efficacy. Study enrollment was not complete at that time, therefore planned sample sizes were not met. Participants discontinued study drug and transitioned into the post-treatment follow-up period. As a result of the decision to terminate the study, all statistical analyses were descriptive and no hypothesis testing was performed.",5.0,,Lack of efficacy,f,,,,t,t,f,,,,,,,,,,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,INDUSTRY,,,,,,,2020,0.0
NCT04400682,,2020-05-19,2020-06-21,,2020-08-07,2020-05-19,2020-05-22,ACTUAL,2020-08-07,2020-08-11,ACTUAL,,,,2020-08-07,2020-08-11,ACTUAL,2020-05-28,ACTUAL,2020-05-28,2020-08,2020-08-31,2020-06-18,ACTUAL,2020-06-18,2020-06-05,ACTUAL,2020-06-05,,INTERVENTIONAL,Favipiravir,,"Bioequivalence Study of Favipiravir 200 mg Film Tablet (Novelfarma, Turkey) Under Fasting Conditions","Open-label, Randomised, Single Oral Dose, Two-period, Cross-over Trial to Assess to Bioequivalence of Favira 200 mg FT in Comparison With Avigan 200 mg FT in Healthy Male Subjects Under Fasting Conditions",COMPLETED,,PHASE1,30.0,ACTUAL,Novelfarma Ilaç San. ve Tic. Ltd. Sti.,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,INDUSTRY,,,,,,,2020,1.0
NCT04697758,,2020-12-17,2024-01-29,,2024-03-20,2021-01-04,2021-01-06,ACTUAL,2024-03-20,2024-03-22,ACTUAL,,,,2024-03-20,2024-03-22,ACTUAL,2020-12-10,ACTUAL,2020-12-10,2024-03,2024-03-31,2022-10-01,ACTUAL,2022-10-01,2022-10-01,ACTUAL,2022-10-01,,INTERVENTIONAL,CONGO,Enrollment was closed after mid dose cohort were enrolled. The study only enrolled 6 subjects.,Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema,Phase 1/2a Study of the Safety and Bioactivity of AXT-107 in Subjects With Diabetic Macular Edema (DME),TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,"AsclepiX Therapeutics, Inc.",,3.0,,Adverse Events,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,INDUSTRY,,,,,,,2022,0.0
NCT05275673,,2022-02-07,,,2023-03-31,2022-03-02,2022-03-11,ACTUAL,,,,,,,2023-03-31,2023-04-04,ACTUAL,2022-04-15,ACTUAL,2022-04-15,2023-03,2023-03-31,2023-03-10,ACTUAL,2023-03-10,2023-03-10,ACTUAL,2023-03-10,,INTERVENTIONAL,,,A Study of Sapanisertib in Relapsed/Refractory NFE2L2-Mutated and Wild-Type Squamous Non-Small Cell Lung Cancer,"A Randomized, Open-Label Phase 2 Study of the TORC 1/2 Inhibitor Sapanisertib in Relapsed/Refractory NFE2L2 (NRF2)-Mutated and Wild-Type (WT) Squamous Non-Small Cell Lung Cancer (sqNSCLC)",TERMINATED,,PHASE2,7.0,ACTUAL,"Calithera Biosciences, Inc",,4.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,NO,We do not plan to share the individual participant data with other researchers,2024-10-14 22:32:10.753576,2024-10-14 22:32:10.753576,INDUSTRY,,,,,,,2023,0.0
NCT03796195,,2019-01-03,2022-07-13,,2023-01-03,2019-01-04,2019-01-08,ACTUAL,2023-01-03,2023-01-25,ACTUAL,,,,2023-01-03,2023-01-25,ACTUAL,2019-11-13,ACTUAL,2019-11-13,2023-01,2023-01-31,2021-07-16,ACTUAL,2021-07-16,2021-07-16,ACTUAL,2021-07-16,,INTERVENTIONAL,,,(SGB) in Men Treated for Prostate Cancer Improve Hot Flashes,Does Stellate Ganglion Blockade (SGB) in Men Treated for Prostate Cancer Improve Hot Flashes? A Pilot Prospective Cohort Study,TERMINATED,,PHASE4,1.0,ACTUAL,Northwestern University,The study was closed early for slow enrollment.,1.0,,Enrollment issues,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,OTHER,,,,,,,2021,0.0
NCT04232280,,2020-01-09,,2023-12-29,2023-12-29,2020-01-14,2020-01-18,ACTUAL,,,,,2024-01-03,ACTUAL,2023-12-29,2024-01-03,ACTUAL,2020-01-09,ACTUAL,2020-01-09,2023-12,2023-12-31,2023-01-04,ACTUAL,2023-01-04,2023-01-04,ACTUAL,2023-01-04,,INTERVENTIONAL,,,Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults,"A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus Vaccine mRNA-1647 in Healthy Adults",COMPLETED,,PHASE2,315.0,ACTUAL,"ModernaTX, Inc.",,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,INDUSTRY,,,,,,,2023,1.0
NCT04678505,,2020-12-16,2022-04-05,,2022-04-05,2020-12-16,2020-12-22,ACTUAL,2022-04-05,2022-11-04,ACTUAL,,,,2022-04-05,2022-11-04,ACTUAL,2021-02-10,ACTUAL,2021-02-10,2022-04,2022-04-30,2021-04-27,ACTUAL,2021-04-27,2021-04-15,ACTUAL,2021-04-15,,INTERVENTIONAL,,"The Baseline Analysis Population consists of participants in Panels A and B. The study was terminated early due to business reasons prior to enrollment of Panels C, D, and E; thus, no baseline characteristics are presented for healthy control participants and participants with severe RI or ESRD.",Study of a Single Intravenous (IV) Dose of MK-3402 in Participants With Impaired Renal Function and in Healthy Controls (MK-3402-004),"An Open-Label Trial to Evaluate the Pharmacokinetics of MK-3402 Following Administration of a Single IV Dose to Participants With Mild, Moderate, and Severe Renal Impairment and End-Stage Renal Disease",TERMINATED,,PHASE1,9.0,ACTUAL,Merck Sharp & Dohme LLC,"Due to early study termination, some of the planned endpoints were not able to be completed.",5.0,,Business reasons,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,INDUSTRY,,,,,,,2021,0.0
NCT03907813,,2019-04-05,,,2020-07-28,2019-04-05,2019-04-09,ACTUAL,,,,,,,2020-07-28,2020-07-31,ACTUAL,2019-05-01,ESTIMATED,2019-05-01,2020-07,2020-07-31,2020-07-31,ESTIMATED,2020-07-31,2020-06-30,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,Liposomal Bupivacaine After Cesarean Delivery,The Effect of Local Infiltration of Liposomal Bupivacaine on Opioid Consumption at Time of Cesarean Delivery: A Randomized Controlled Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,Wright State University,,2.0,,change in design,f,,,,f,t,f,,,f,,,,,,NO,Data will be shared on a case by case basis.,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,OTHER,,,,,,,2020,0.0
NCT04078191,,2019-08-21,,,2024-07-23,2019-09-03,2019-09-04,ACTUAL,,,,,,,2024-07-23,2024-07-25,ACTUAL,2021-09-14,ACTUAL,2021-09-14,2024-07,2024-07-31,2024-07-09,ACTUAL,2024-07-09,2024-07-09,ACTUAL,2024-07-09,,INTERVENTIONAL,,,Comparison of Tc 99m Tilmanocept Imaging With IHC Analysis of CD206 Expression in Synovial Tissue of Subjects With RA,A Comparison of Tc 99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue From Subjects Clinically Diagnosed With Rheumatoid Arthritis (RA),TERMINATED,,PHASE2,23.0,ACTUAL,Navidea Biopharmaceuticals,,1.0,,Sponsor decision.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,INDUSTRY,,,,,,,2024,0.0
NCT04489446,,2020-07-25,,,2021-09-27,2020-07-25,2020-07-28,ACTUAL,,,,,,,2021-09-27,2021-09-29,ACTUAL,2020-08-19,ACTUAL,2020-08-19,2021-09,2021-09-30,2021-06-30,ACTUAL,2021-06-30,2021-04-30,ACTUAL,2021-04-30,,INTERVENTIONAL,,,Sildenafil in COVID-19,Sildenafil for Treating Patients With COVID-19 and Perfusion Mismatch: A Pilot Randomised Trial,COMPLETED,,PHASE1/PHASE2,40.0,ACTUAL,Universidad Nacional Andres Bello,,2.0,,,f,,,,f,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,OTHER,,,,,,,2021,0.0
NCT05116683,,2021-10-18,2023-10-27,,2023-11-14,2021-11-09,2021-11-11,ACTUAL,2023-11-14,2023-12-06,ACTUAL,,,,2023-11-14,2023-12-06,ACTUAL,2022-01-11,ACTUAL,2022-01-11,2023-11,2023-11-30,2022-10-27,ACTUAL,2022-10-27,2022-10-27,ACTUAL,2022-10-27,,INTERVENTIONAL,ATX-101,,ATX-101 in Advanced Dedifferentiated Liposarcoma and Leiomyosarcoma,"A Phase II Study, With a Safety lead-in, to Evaluate ATX-101, a Peptide Drug Targeting PCNA, in Advanced Dedifferentiated Liposarcoma and Leiomyosarcoma",TERMINATED,,PHASE2,4.0,ACTUAL,Columbia University,,1.0,,Study terminated by PI,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,OTHER,,,,,,,2022,0.0
NCT03063606,,2017-02-03,2022-11-30,,2024-01-03,2017-02-20,2017-02-24,ACTUAL,2023-06-14,2023-07-07,ACTUAL,,,,2024-01-03,2024-02-01,ACTUAL,2017-09-05,ACTUAL,2017-09-05,2024-01,2024-01-31,2022-12-16,ACTUAL,2022-12-16,2021-12-01,ACTUAL,2021-12-01,,INTERVENTIONAL,,,Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment,Behavioral and Pharmacologic Treatment of Binge Eating and Obesity,COMPLETED,,PHASE2/PHASE3,31.0,ACTUAL,Yale University,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-14 22:32:10.753576,2024-10-14 22:32:10.753576,OTHER,,,,,,,2022,1.0
NCT03763734,,2018-11-28,,,2021-06-29,2018-12-03,2018-12-04,ACTUAL,,,,,,,2021-06-29,2021-06-30,ACTUAL,2019-01-29,ACTUAL,2019-01-29,2021-06,2021-06-30,2021-01-01,ACTUAL,2021-01-01,2021-01-01,ACTUAL,2021-01-01,,INTERVENTIONAL,,,High-Dose Steroid for Knee Arthroplasty Patients Expected to Have Postoperative Pain,High-Dose Steroids in High Pain Responders Undergoing Total Knee-arthroplasty: A Randomized Double Blinded Controlled Trial,COMPLETED,,PHASE4,88.0,ACTUAL,"Copenhagen University Hospital, Hvidovre",,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-14 22:32:10.753576,2024-10-14 22:32:10.753576,OTHER,,,,,,,2021,1.0
NCT03982277,,2019-05-30,,,2023-03-21,2019-06-10,2019-06-11,ACTUAL,,,,,,,2023-03-21,2023-03-23,ACTUAL,2019-04-30,ACTUAL,2019-04-30,2022-03,2022-03-31,2021-07-23,ACTUAL,2021-07-23,2021-03-16,ACTUAL,2021-03-16,,INTERVENTIONAL,SAEFRIF,,Safety and Efficacy of High Dose Rifampicin in Tuberculosis (TB)-HIV Co-infected Patients on Efavirenz- or Dolutegravir-based Antiretroviral Therapy,"A Randomized, Four-arm Open Label Phase Two-b Clinical Trial to Evaluate the Pharmacokinetics, Safety/Tolerability and Efficacy of High Dose Rifampicin in TB-HIV Co-infected Patients on Efavirenz- or Dolutegravir-based Antiretroviral Therapy",COMPLETED,,PHASE2,130.0,ACTUAL,Makerere University,,4.0,,,f,,,,t,f,f,,,,,,6 months after publication of study results.,Direct request shall be made to Infectious Diseases Institute for pooling of data and met-analysis,,YES,Individual patient data (IPD) will made available to other researchers for further analysis or met-analysis following direct request to the sponsor (Infectious Diseases Institute).,2024-10-14 22:32:10.753576,2024-10-14 22:32:10.753576,OTHER,,,,,,,2021,1.0
NCT04449380,,2020-06-23,,,2021-04-28,2020-06-25,2020-06-26,ACTUAL,,,,,,,2021-04-28,2021-05-03,ACTUAL,2020-11-02,ACTUAL,2020-11-02,2021-04,2021-04-30,2021-03-30,ACTUAL,2021-03-30,2021-03-30,ACTUAL,2021-03-30,,INTERVENTIONAL,INTERCOP,,Clinical Study for the Treatment With Interferon-ß-1a (IFNß-1a) of COVID-19 Patients,"Randomized, Controlled, Open Label, Phase 2 Clinical Trial of Interferon-β-1a (IFNβ-1a) in COVID-19 Patients",TERMINATED,,PHASE2,56.0,ACTUAL,IRCCS San Raffaele,,2.0,,Futility,f,,,,f,f,f,,,,,,,,,,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,OTHER,,,,,,,2021,0.0
NCT04659122,,2020-12-04,,,2023-08-11,2020-12-07,2020-12-09,ACTUAL,,,,,,,2023-08-11,2023-08-14,ACTUAL,2021-08-17,ACTUAL,2021-08-17,2023-07,2023-07-31,2023-02-23,ACTUAL,2023-02-23,2023-02-23,ACTUAL,2023-02-23,,INTERVENTIONAL,,,A Clinical Safety Study on AT-100 in Treating Adults With Severe COVID-19 Infection or Severed Community Acquired Pneumonia,"Phase 1b Open-label, Single Arm, Cohort Dose Escalation Study Evaluating the Safety, Tolerability, and Feasibility of Intervention With AT-100 (rhSP-D) in Intubated Patients Receiving Invasive Mechanical Ventilation With Severe COVID-19 Infection or Respiratory Failure Secondary to Severe Community Acquired Pneumonia",TERMINATED,,PHASE1,5.0,ACTUAL,"Airway Therapeutics, Inc.",,3.0,,Termination / study goals reached,f,,,,t,t,f,,,,,,,,,,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,INDUSTRY,,,,,,,2023,0.0
NCT03408405,,2018-01-08,,,2019-04-19,2018-01-22,2018-01-24,ACTUAL,,,,,,,2019-04-19,2019-04-23,ACTUAL,2018-06,ESTIMATED,2018-06-30,2019-04,2019-04-30,2021-07,ESTIMATED,2021-07-31,2021-01,ESTIMATED,2021-01-31,,INTERVENTIONAL,ADRENL,,ACTHAR Gel for Drug REsistant Nephrotic Syndrome in Children,"ADRENL - ACTHAR Gel for Drug REsistant Nephrotic Syndrome in Children, Pilot Study",WITHDRAWN,,PHASE4,0.0,ACTUAL,Rhode Island Hospital,,1.0,,Withdrawal of funding from primary sponsor,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,OTHER,,,,,,,2021,0.0
NCT03881735,,2019-03-15,,,2021-03-08,2019-03-18,2019-03-19,ACTUAL,,,,,,,2021-03-08,2021-03-10,ACTUAL,2019-12-02,ACTUAL,2019-12-02,2021-03,2021-03-31,2022-11-19,ESTIMATED,2022-11-19,2021-11-19,ESTIMATED,2021-11-19,,INTERVENTIONAL,,,Enasidenib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia With an IDH2 Gene Mutation,A Phase II Study of Intensive Salvage Therapy Followed by Enasidenib for Patients With AML Harboring Mutations in IDH2 Who Have Failed or Been Refractory to One Prior Line of Therapy,WITHDRAWN,,PHASE2,0.0,ACTUAL,Roswell Park Cancer Institute,,2.0,,no accrual,,,,,t,t,f,,,f,,,,,,,,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,OTHER,,,,,,,2022,0.0
NCT04787731,,2021-03-04,,,2023-11-07,2021-03-04,2021-03-09,ACTUAL,,,,,,,2023-11-07,2023-11-08,ACTUAL,2019-07-29,ACTUAL,2019-07-29,2023-11,2023-11-30,2024-10-01,ESTIMATED,2024-10-01,2024-10-01,ESTIMATED,2024-10-01,,INTERVENTIONAL,B-OHIP14,,Efficacy of Two Local Anesthetics on Quality of Life After Endodontic Treatment,Efficacy of Two Dental Local Anesthetics on the Oral Health-Related Quality of Life After Endodontic Treatment in the Symptomatic Mandibular Molars: A Double Blind Randomized Controlled Trial,SUSPENDED,,PHASE4,100.0,ESTIMATED,NYU College of Dentistry,,2.0,,COVID-19 and Personnel changes,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,OTHER,,,,,,,2024,0.0
NCT04141930,,2019-10-23,2021-04-02,,2021-07-13,2019-10-24,2019-10-28,ACTUAL,2021-07-13,2021-08-05,ACTUAL,,,,2021-07-13,2021-08-05,ACTUAL,2019-11-01,ACTUAL,2019-11-01,2021-07,2021-07-31,2020-04-01,ACTUAL,2020-04-01,2020-04-01,ACTUAL,2020-04-01,,INTERVENTIONAL,pCHIMES,Based on individuals that contributed data during the test-and-treat phase of the protocol.,Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle,Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle (pCHIMES),COMPLETED,,PHASE4,481.0,ACTUAL,University of Washington,,1.0,,,f,,,,t,t,f,,,f,,,,,,NO,"We do not currently expect to share specimens with outside investigators, but if compelling opportunities arise that will advance the overall objectives of this research, the Executive Committee of the study will consider such requests. They alone have the authority to make such decisions.~All biospecimens (nasal swabs) will be coded and identifiable through the study's main database. Any specimens shared with external investigators (if deemed appropriate by the Executive Committee) will have identifiers removed prior to sharing.",2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,OTHER,,,,,,,2020,1.0
NCT04228445,,2019-12-23,2022-10-06,,2022-11-04,2020-01-13,2020-01-14,ACTUAL,2022-11-04,2022-11-30,ACTUAL,,,,2022-11-04,2022-11-30,ACTUAL,2020-02-13,ACTUAL,2020-02-13,2022-11,2022-11-30,2021-06-03,ACTUAL,2021-06-03,2021-06-03,ACTUAL,2021-06-03,,INTERVENTIONAL,UP,"Population presented is the Safety Analysis Set, while the population presented in the Participant Flow was the all randomized population","3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency","An Open-Label Study of Two Different Doses of 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution When Used as an Aid for Ureteral Patency",COMPLETED,,PHASE3,121.0,ACTUAL,Prove pharm,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,INDUSTRY,,,,,,,2021,1.0
NCT04353505,,2020-03-10,,,2020-07-31,2020-04-17,2020-04-20,ACTUAL,,,,,,,2020-07-31,2020-08-04,ACTUAL,2020-10,ESTIMATED,2020-10-31,2020-07,2020-07-31,2023-06,ESTIMATED,2023-06-30,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache,Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache,WITHDRAWN,,PHASE1,0.0,ACTUAL,Weill Medical College of Cornell University,,1.0,,PI closed the study before any enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,OTHER,,,,,,,2023,0.0
NCT04662060,,2020-12-08,2023-05-02,,2023-06-09,2020-12-09,2020-12-10,ACTUAL,2023-06-09,2023-06-13,ACTUAL,,,,2023-06-09,2023-06-13,ACTUAL,2021-04-23,ACTUAL,2021-04-23,2023-06,2023-06-30,2023-02-02,ACTUAL,2023-02-02,2022-05-03,ACTUAL,2022-05-03,,INTERVENTIONAL,COPPS,Intent-to-treat population (all randomized participants),COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Acebilustat Sub-Protocol,"COVID-19 Outpatient Pragmatic Platform Study (COPPS): A Pragmatic Multi-arm, Adaptive, Phase 2, Blinded, Randomized Placebo-controlled Platform Trial to Assess the Efficacy of Different Investigational Therapeutics in Reducing Time to Disease Resolution or Viral Load Cessation, as Compared to Standard Supportive Care in Outpatients With COVID-19",COMPLETED,,PHASE2,120.0,ACTUAL,Stanford University,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,OTHER,,,,,,,2023,1.0
NCT03340974,,2017-11-08,2023-01-11,2021-08-03,2023-11-29,2017-11-09,2017-11-14,ACTUAL,2023-11-29,2023-12-15,ACTUAL,,2023-12-15,ACTUAL,2023-11-29,2023-12-15,ACTUAL,2018-02-12,ACTUAL,2018-02-12,2023-01,2023-01-31,2021-05-26,ACTUAL,2021-05-26,2020-08-21,ACTUAL,2020-08-21,,INTERVENTIONAL,,,Pilot Dose Escalation Trial of Stereotactic Body Radiation Therapy (SBRT) in Combination With GC4419 in Pancreatic Cancer,An Adaptive Phase I/II Dose Escalation Trial of Stereotactic Body Radiation Therapy in Combination With Radiomodulating Agent GC4419 in Locally Advanced Pancreatic Adenocarcinoma,COMPLETED,,PHASE1/PHASE2,42.0,ACTUAL,"Galera Therapeutics, Inc.",,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:38:58.903479,2024-10-16 19:38:58.903479,INDUSTRY,,,,,,,2021,1.0
NCT03943290,,2019-04-17,2021-03-11,,2022-09-13,2019-05-07,2019-05-09,ACTUAL,2021-05-07,2021-06-02,ACTUAL,,,,2022-09-13,2022-09-26,ACTUAL,2019-05-10,ACTUAL,2019-05-10,2022-09,2022-09-30,2020-03-11,ACTUAL,2020-03-11,2020-03-11,ACTUAL,2020-03-11,,INTERVENTIONAL,,The safety population was used for baseline analysis- The Safety Population consisted of all participants enrolled/randomized in the study who received at least 1 dose of study drug.,Extension Study to Evaluate the Long-Term Effects of ACE-083 in Patients With Facioscapulohumeral Muscular Dystrophy (FSHD) and Charcot-Marie Tooth (CMT) Disease Types 1 and X (CMT1 and CMTX),An Open-Label Extension Study to Evaluate the Long-Term Effects of ACE-083 in Patients With Facioscapulohumeral Muscular Dystrophy (FSHD) Previously Enrolled in Study A083-02 and in Patients With Charcot-Marie Tooth (CMT) Disease Types 1 and X Previously Enrolled in Study A083-03,TERMINATED,,PHASE2,62.0,ACTUAL,"Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA","In this open-label, multicenter, phase 2 extension study in participants with FSHD and CMT (types 1 and X), treatment with ACE-083 q4w or q8w was generally safe and well tolerated. Participants were discontinued from this study when their respective parent studies were terminated by the sponsor, and as such, this study was also terminated. Due to premature termination of this study, insufficient efficacy data were obtained to enable meaningful efficacy analyses.",9.0,,Investigation of ACE-083 for use in patients with CMT and FSHD is being discontinued in this extension study as functional secondary endpoints were not achieved in the A083-023 or A083-03 trial (the parent trials).,f,,,,,t,f,,,,,,,,,,,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,INDUSTRY,,,,,,,2020,0.0
NCT04362189,,2020-04-21,2023-06-07,,2023-07-04,2020-04-23,2020-04-24,ACTUAL,2023-07-04,2023-07-25,ACTUAL,,,,2023-07-04,2023-07-25,ACTUAL,2020-06-30,ACTUAL,2020-06-30,2023-07,2023-07-31,2021-09-30,ACTUAL,2021-09-30,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,,Summary of baseline characteristics for all enrolled subjects.,Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19,"A Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19",TERMINATED,,PHASE2,48.0,ACTUAL,Hope Biosciences,,2.0,,No need to continue with the availability of the COVID-19 VACCINE,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,INDUSTRY,,,,,,,2021,0.0
NCT02389465,,2015-02-27,2023-07-19,,2023-09-18,2015-03-16,2015-03-17,ESTIMATED,2023-09-18,2023-10-02,ACTUAL,,,,2023-09-18,2023-10-02,ACTUAL,2014-08,,2014-08-31,2023-09,2023-09-30,2022-07-18,ACTUAL,2022-07-18,2022-07-18,ACTUAL,2022-07-18,,INTERVENTIONAL,S&I,,Stress and Inflammation in Late-Life Depression,Stress and Inflammation in the Pathophysiology of Late Life Depression,COMPLETED,,PHASE4,119.0,ACTUAL,University of Pennsylvania,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,OTHER,,,,,,,2022,1.0
NCT03825380,,2019-01-21,2022-05-12,,2023-02-09,2019-01-30,2019-01-31,ACTUAL,2023-02-09,2023-11-21,ACTUAL,,,,2023-02-09,2023-11-21,ACTUAL,2018-11-23,ACTUAL,2018-11-23,2023-02,2023-02-28,2021-02-24,ACTUAL,2021-02-24,2021-02-03,ACTUAL,2021-02-03,,INTERVENTIONAL,,,Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients,Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients,COMPLETED,,PHASE3,485.0,ACTUAL,Laboratoires Thea,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,INDUSTRY,,,,,,,2021,1.0
NCT03240861,,2017-06-22,,,2023-10-30,2017-08-03,2017-08-07,ACTUAL,,,,,,,2023-10-30,2023-11-01,ACTUAL,2017-07-26,ACTUAL,2017-07-26,2023-10,2023-10-31,2023-10-19,ACTUAL,2023-10-19,2023-10-19,ACTUAL,2023-10-19,,INTERVENTIONAL,NYESO SCT,,Genetically Engineered PBMC and PBSC Expressing NY-ESO-1 TCR After a Myeloablative Conditioning Regimen to Treat Patients With Advanced Cancer,"Adoptive Transfer of NY-ESO-1 TCR Engineered Peripheral Blood Mononuclear Cells (PBMC) and Peripheral Blood Stem Cells (PBSC) After a Myeloablative Conditioning Regimen, With Administration of Interleukin-2, in Patients With Advanced Malignancies",TERMINATED,,PHASE1,5.0,ACTUAL,Jonsson Comprehensive Cancer Center,,1.0,,slow accrual,,,,,t,t,f,,,,,,,,,,,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,OTHER,,,,,,,2023,0.0
NCT04620473,,2020-10-29,,,2021-09-22,2020-11-06,2020-11-09,ACTUAL,,,,,,,2021-09-22,2021-09-28,ACTUAL,2023-11-01,ESTIMATED,2023-11-01,2021-09,2021-09-30,2024-10-01,ESTIMATED,2024-10-01,2023-12-01,ESTIMATED,2023-12-01,,INTERVENTIONAL,,,Anlotinib Hydrochloride Combined With Capeox in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer,"Anlotinib Hydrochloride Combined With Capeox in the Neoadjuvant Treatment of Locally Advanced Rectal cancer-a Prospective, Open, Single Center and Randomized Controlled Phase Ⅱ Clinical Trial",WITHDRAWN,,PHASE2,0.0,ACTUAL,Shanghai Minimally Invasive Surgery Center,,2.0,,No approval from ethical committee,f,,,,,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,OTHER,,,,,,,2024,0.0
NCT04039113,,2019-07-29,,,2024-02-21,2019-07-29,2019-07-31,ACTUAL,,,,,,,2024-02-21,2024-02-22,ACTUAL,2019-07-30,ACTUAL,2019-07-30,2024-02,2024-02-29,2024-01-31,ACTUAL,2024-01-31,2023-11-10,ACTUAL,2023-11-10,,INTERVENTIONAL,COURSE,,Tezepelumab COPD Exacerbation Study,"A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)",COMPLETED,,PHASE2,337.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,INDUSTRY,,,,,,,2024,1.0
NCT05393089,,2022-05-23,,,2022-06-24,2022-05-23,2022-05-26,ACTUAL,,,,,,,2022-06-24,2022-06-29,ACTUAL,2022-06-09,ESTIMATED,2022-06-09,2022-06,2022-06-30,2023-04-04,ESTIMATED,2023-04-04,2023-04-04,ESTIMATED,2023-04-04,,INTERVENTIONAL,ARIES,,Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia,"A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Subjects With Pseudophakic Presbyopia",WITHDRAWN,,PHASE2,0.0,ACTUAL,Allergan,,2.0,,Business Decision,f,,,,f,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,INDUSTRY,,,,,,,2023,0.0
NCT00437359,,2007-02-18,,,2012-03-28,2007-02-20,2007-02-21,ESTIMATED,,,,,,,2012-03-28,2012-03-30,ESTIMATED,2007-05,,2007-05-31,2012-03,2012-03-31,2020-05,ESTIMATED,2020-05-31,2017-05,ESTIMATED,2017-05-31,,INTERVENTIONAL,,,Antiestrogen vs Aromatase Inhibitor After Adjuvant Chemotherapy for Breast Cancer,Antiestrogen vs Aromatase Inhibitor After Chemotherapy for Adjuvant Setting: Efficacy of Endocrine Therapy After Chemotherapy in Postoperative Adjuvant Therapy for Breast Cancer,TERMINATED,,PHASE2,240.0,ESTIMATED,Japan Breast Cancer Research Network,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 19:45:25.709733,2024-10-16 19:45:25.709733,OTHER,,,,,,,2020,0.0
NCT02770378,,2016-03-14,,,2021-10-04,2016-05-11,2016-05-12,ESTIMATED,,,,,,,2021-10-04,2021-10-05,ACTUAL,2016-11,ACTUAL,2016-11-30,2021-10,2021-10-31,2020-12,ACTUAL,2020-12-31,2018-10,ACTUAL,2018-10-31,,INTERVENTIONAL,,,A Proof-of-concept Clinical Trial Assessing the Safety of the Coordinated Undermining of Survival Paths by 9 Repurposed Drugs Combined With Metronomic Temozolomide (CUSP9v3 Treatment Protocol) for Recurrent Glioblastoma,A Proof-of-concept Clinical Trial Assessing the Safety of the Coordinated Undermining of Survival Paths by 9 Repurposed Drugs Combined With Metronomic Temozolomide (CUSP9v3 Treatment Protocol) for Recurrent Glioblastoma,COMPLETED,,PHASE1/PHASE2,10.0,ACTUAL,University of Ulm,,1.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,OTHER,,,,,,,2020,1.0
NCT06301308,,2024-03-03,,,2024-04-22,2024-03-03,2024-03-08,ACTUAL,,,,,,,2024-04-22,2024-04-24,ACTUAL,2023-10-01,ACTUAL,2023-10-01,2024-04,2024-04-30,2024-02-29,ESTIMATED,2024-02-29,2024-02-29,ESTIMATED,2024-02-29,,INTERVENTIONAL,,,A Novel Application of 2% Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial,A Novel Application of 2% Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,Second Xiangya Hospital of Central South University,,3.0,,"The standard measures of anaesthesia in cystoscopy are not uniform internationally, and given this, we were unable to recruit the first participant in the study.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,OTHER,,,,,,,2024,0.0
NCT03187405,,2017-06-06,,,2024-03-04,2017-06-12,2017-06-15,ACTUAL,,,,,,,2024-03-04,2024-03-05,ACTUAL,2018-02-21,ACTUAL,2018-02-21,2024-02,2024-02-29,2024-03-15,ESTIMATED,2024-03-15,2024-03-15,ESTIMATED,2024-03-15,,INTERVENTIONAL,FIVHeMA,,Intraventricular Fibrinolysis for Aneurysmal Subarachnoid Hemorrhage.,Intraventricular Fibrinolysis Versus External Ventricular Drainage Alone in Aneurysmal Subarachnoid Hemorrhage: a Randomized Controlled Trial.,SUSPENDED,,PHASE3,440.0,ESTIMATED,"University Hospital, Caen",,2.0,,Slow recruitment rate,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,OTHER,,,,,,,2024,0.0
NCT03682055,,2018-09-20,2021-11-16,,2023-07-24,2018-09-21,2018-09-24,ACTUAL,2023-07-24,2023-08-15,ACTUAL,,,,2023-07-24,2023-08-15,ACTUAL,2019-04-04,ACTUAL,2019-04-04,2023-07,2023-07-31,2020-08-08,ACTUAL,2020-08-08,2020-06-23,ACTUAL,2020-06-23,,INTERVENTIONAL,,,Phase 1/2a Study of VK-2019 in Patients With Epstein-Barr Virus (EBV)-Positive Nasopharyngeal Carcinoma (NPC),"Phase 1/2a Open Label, Multicenter Clinical Trial of a Novel Small Molecule EBNA1 Inhibitor, VK 2019, in Patients With Epstein Barr Virus Positive Nasopharyngeal Cancer, With Pharmacokinetic and Pharmacodynamic Correlative Studies",TERMINATED,,PHASE1/PHASE2,14.0,ACTUAL,Cullinan Therapeutics Inc.,,4.0,,Lack of efficacy,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,INDUSTRY,,,,,,,2020,0.0
NCT04341116,,2020-04-04,2023-02-06,,2023-05-03,2020-04-09,2020-04-10,ACTUAL,2023-05-03,2023-05-06,ACTUAL,,,,2023-05-03,2023-05-06,ACTUAL,2020-04-11,ACTUAL,2020-04-11,2023-05,2023-05-31,2022-02-07,ACTUAL,2022-02-07,2022-02-07,ACTUAL,2022-02-07,,INTERVENTIONAL,,,Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19),"A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of TJ003234 in Subjects With Severe Coronavirus Disease 2019 (COVID-19)",COMPLETED,,PHASE2/PHASE3,149.0,ACTUAL,I-Mab Biopharma US Limited,,4.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,INDUSTRY,,,,,,,2022,1.0
NCT04176393,,2019-10-29,,,2023-02-10,2019-11-21,2019-11-25,ACTUAL,,,,,,,2023-02-10,2023-02-13,ACTUAL,2019-11-12,ACTUAL,2019-11-12,2023-02,2023-02-28,2023-01-18,ACTUAL,2023-01-18,2021-02-18,ACTUAL,2021-02-18,,INTERVENTIONAL,,,A China Bridging Study of Ivosidenib in r/r AML Subjects With an IDH1 Mutation,"A Phase 1, Multicenter, Single-Arm Study Evaluating Pharmacokinetic, Pharmacodynamic, Safety, and Clinical Efficacy of Orally Administered Ivosidenib in Chinese Subjects With Relapsed or Refractory Acute Myeloid Leukemia With an IDH1 Mutation",COMPLETED,,PHASE1,30.0,ACTUAL,CStone Pharmaceuticals,,1.0,,,f,,,,f,t,f,,,t,,,,,,,,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,INDUSTRY,,,,,,,2023,1.0
NCT05716295,,2023-01-19,,,2024-05-06,2023-02-06,2023-02-08,ACTUAL,,,,,,,2024-05-06,2024-05-08,ACTUAL,2023-02-08,ACTUAL,2023-02-08,2024-05,2024-05-31,2024-04-30,ACTUAL,2024-04-30,2024-04-30,ACTUAL,2024-04-30,,INTERVENTIONAL,ORCHID-1,,A Dose Escalation/Expansion Study of MDK-703 in Patients With Advanced or Metastatic Solid Tumors,"A Phase 1/2, Open-Label, Multicenter Study of MDK-703 as a Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced or Metastatic Solid Tumors (ORCHID-1)",TERMINATED,,PHASE1/PHASE2,26.0,ACTUAL,"Medikine, Inc.",,2.0,,Corporate decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,INDUSTRY,,,,,,,2024,0.0
NCT03660683,,2018-08-17,2022-11-02,,2023-06-02,2018-09-04,2018-09-06,ACTUAL,2023-06-02,2023-06-05,ACTUAL,,,,2023-06-02,2023-06-05,ACTUAL,2018-10-22,ACTUAL,2018-10-22,2023-06,2023-06-30,2021-12-10,ACTUAL,2021-12-10,2021-03-11,ACTUAL,2021-03-11,,INTERVENTIONAL,,,Effect of Saxagliptin and Dapagliflozin on Endothelial Progenitor Cell in Patients With Type 2 Diabetes Mellitus,Cardio-Protective of Effect of Saxagliptin and Dapagliflozin Combination on Endothelial Progenitor Cells in Patients With Type 2 Diabetes,TERMINATED,,PHASE4,15.0,ACTUAL,George Washington University,"Study is limited by the small cohort used in each group. Many visit 2 data points missing, reported analysis only performed with visit 1 and 3 data.",3.0,,Sponsor did not want to continue funding the study,f,,,,,t,f,,,t,,,,,,UNDECIDED,,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,OTHER,,,,,,,2021,0.0
NCT03106987,,2017-03-24,2022-02-15,,2022-09-13,2017-04-04,2017-04-11,ACTUAL,2022-02-22,2022-04-19,ACTUAL,,,,2022-09-13,2022-10-07,ACTUAL,2017-06-08,ACTUAL,2017-06-08,2022-06,2022-06-30,2022-02-17,ACTUAL,2022-02-17,2021-02-15,ACTUAL,2021-02-15,,INTERVENTIONAL,OReO,Full analysis set (FAS) consisted of all randomised patients analysed on an intent-to-treat (ITT) basis.,A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer.,"A Phase IIIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study of Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer Previously Treated With a PARPi and Responding to Repeat Platinum Chemotherapy",COMPLETED,,PHASE3,220.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-16 19:45:25.709733,2024-10-16 19:45:25.709733,INDUSTRY,,,,,,,2022,1.0
NCT03191162,,2017-06-08,,,2023-12-18,2017-06-16,2017-06-19,ACTUAL,,,,,,,2023-12-18,2023-12-19,ACTUAL,2017-04-21,ACTUAL,2017-04-21,2023-12,2023-12-31,2021-03-16,ACTUAL,2021-03-16,2020-09-21,ACTUAL,2020-09-21,,INTERVENTIONAL,MULTIBENZ,,Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease.,Phase II Clinical Trial for the Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease in Adult Patients. Berenice Project,COMPLETED,,PHASE2,238.0,ACTUAL,Hospital Universitari Vall d'Hebron Research Institute,,3.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,OTHER,,,,,,,2021,1.0
NCT04624672,,2020-11-05,2022-10-19,,2023-10-31,2020-11-05,2020-11-12,ACTUAL,2023-01-13,2023-02-08,ACTUAL,,,,2023-10-31,2023-11-14,ACTUAL,2021-08-25,ACTUAL,2021-08-25,2023-10,2023-10-31,2022-08-17,ACTUAL,2022-08-17,2022-07-18,ACTUAL,2022-07-18,,INTERVENTIONAL,NOVO-GLP1,"Due to low recruitment numbers (\>5), no data analysis was completed because total number of patients recruited is too low to ensure patient confidentiality.",Treatment of GLP-1 for Diabetic Bariatric Patients,GLP-1 Agonists as Neoadjuvant Therapy for Surgical Treatment of Type 2 Diabetes: A Randomized Controlled Trial,TERMINATED,,PHASE4,3.0,ACTUAL,Geisinger Clinic,,2.0,,Poor enrollment,f,,,,,t,f,,,t,,,,,,NO,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,OTHER,,,,,,,2022,0.0
NCT03961555,,2019-05-16,,,2022-09-29,2019-05-21,2019-05-23,ACTUAL,,,,,,,2022-09-29,2022-10-03,ACTUAL,2019-09-03,ACTUAL,2019-09-03,2022-09,2022-09-30,2021-12-23,ACTUAL,2021-12-23,2021-12-23,ACTUAL,2021-12-23,,INTERVENTIONAL,ARPEP,,Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies,A Phase 2b Randomized Blinded Study to Evaluate SYN023 Compared to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies in Adults With Different Rabies Exposure Risks,COMPLETED,,PHASE2,448.0,ACTUAL,"Synermore Biologics Co., Ltd.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,INDUSTRY,,,,,,,2021,1.0
NCT04677543,,2020-12-16,2024-05-08,,2024-06-26,2020-12-16,2020-12-21,ACTUAL,2024-06-26,2024-06-28,ACTUAL,,,,2024-06-26,2024-06-28,ACTUAL,2020-12-22,ACTUAL,2020-12-22,2024-06,2024-06-30,2023-05-09,ACTUAL,2023-05-09,2023-05-09,ACTUAL,2023-05-09,,INTERVENTIONAL,ARISE,Intent-to-treat (ITT) Analysis Set comprises all participants who were randomized.,Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex,"A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)",COMPLETED,,PHASE3,99.0,ACTUAL,Insmed Incorporated,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,INDUSTRY,,,,,,,2023,1.0
NCT04171700,,2019-11-19,2023-05-31,,2023-09-29,2019-11-19,2019-11-21,ACTUAL,2023-09-29,2023-10-02,ACTUAL,,,,2023-09-29,2023-10-02,ACTUAL,2020-01-16,ACTUAL,2020-01-16,2023-09,2023-09-30,2022-07-15,ACTUAL,2022-07-15,2022-06-08,ACTUAL,2022-06-08,,INTERVENTIONAL,LODESTAR,,A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes,"A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes",TERMINATED,,PHASE2,83.0,ACTUAL,pharmaand GmbH,,1.0,,The study was terminated due to a change in development priorities.,,,,,t,t,f,,,,,,"Data will be made available to qualified researchers after the primary, secondary, and/or exploratory outcomes of the study are reported or published and for 1 year thereafter.",Requests for de-identified datasets will be made available to qualified researchers following submission of a methodologically sound proposal to medinfo@clovisoncology.com.,,YES,De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations.~Data will be provided by Clovis Oncology.,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,INDUSTRY,,,,,,,2022,0.0
NCT00766779,,2008-10-03,,,2021-10-06,2008-10-03,2008-10-06,ESTIMATED,,,,,,,2021-10-06,2021-10-14,ACTUAL,2010-01,,2010-01-31,2021-10,2021-10-31,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,,,HCT Versus CT in Elderly AML,Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based Conditioning and HCT From Related and Unrelated Donors as Consolidation Therapy for Older Patients With AML in 1st Complete Remission,TERMINATED,,PHASE3,126.0,ACTUAL,European Society for Blood and Marrow Transplantation,,2.0,,Recommendation of DMC,f,,,,t,,,,,,,,,,,,,2024-10-16 19:45:25.709733,2024-10-16 19:45:25.709733,NETWORK,,,,,,,2020,0.0
NCT03311750,,2017-10-02,,,2021-06-02,2017-10-11,2017-10-17,ACTUAL,,,,,,,2021-06-02,2021-06-07,ACTUAL,2018-03-26,ACTUAL,2018-03-26,2021-06,2021-06-30,2021-05-20,ACTUAL,2021-05-20,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,A-REPEAT,,Anti-EGFR Therapy Rechallenge in Combination With Chemotherapy in Patients With Advanced Colorectal Cancer,Single-arm Phase II Study of Panitumumab Rechallenge in Combination With Oxaliplatin or Irinotecan-based Chemotherapy in Patients With RAS Wild Type Advanced Colorectal Cancer.,TERMINATED,,PHASE2,23.0,ACTUAL,Hellenic Cooperative Oncology Group,,1.0,,It was considered that the recruitment of the remaining 10 patients required of the trial will not be possible soon.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 19:45:25.709733,2024-10-16 19:45:25.709733,OTHER,,,,,,,2021,0.0
NCT03953677,,2019-05-15,,,2023-04-26,2019-05-15,2019-05-16,ACTUAL,,,,,,,2023-04-26,2023-04-27,ACTUAL,2019-10-27,ACTUAL,2019-10-27,2023-04,2023-04-30,2023-03-22,ACTUAL,2023-03-22,2023-01-31,ACTUAL,2023-01-31,,INTERVENTIONAL,Adress-Pilot,,Evaluation of the Effect of Dexmedetomidine on Phenylephrine Response During Refractory Septic Shock,A Randomized Controlled Pilot Study Evaluating the Effect of Dexmedetomidine on Phenylephrine Response During Refractory Septic Shock,TERMINATED,,PHASE3,32.0,ACTUAL,Centre Hospitalier Universitaire Dijon,,2.0,,Excess mortality in one arm of the study that led to discontinuation of enrollment,f,,,,,f,f,,,,,,,,,,,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,OTHER,,,,,,,2023,0.0
NCT04639804,,2020-11-16,,,2020-11-20,2020-11-20,2020-11-23,ACTUAL,,,,,,,2020-11-20,2020-11-23,ACTUAL,2020-06-06,ACTUAL,2020-06-06,2020-11,2020-11-30,2020-07-29,ACTUAL,2020-07-29,2020-07-26,ACTUAL,2020-07-26,,INTERVENTIONAL,,,Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers,"An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Tegoprazan and Non-steroidal Anti-inflammatory Drugs (NSAIDs) After Multiple Oral Dosing in Healthy Male Volunteers",COMPLETED,,PHASE1,60.0,ACTUAL,HK inno.N Corporation,,3.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 19:45:25.709733,2024-10-16 19:45:25.709733,INDUSTRY,,,,,,,2020,1.0
NCT03056833,,2017-02-14,,,2022-09-01,2017-02-14,2017-02-17,ACTUAL,,,,,,,2022-09-01,2022-09-07,ACTUAL,2017-06-10,ACTUAL,2017-06-10,2022-08,2022-08-31,2022-08-01,ACTUAL,2022-08-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,,,Ribociclib (Ribociclib (LEE-011)) With Platinum-based Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer,Phase I Trial of Ribociclib (Ribociclib (LEE-011)) With Platinum-based Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer,COMPLETED,,PHASE1,35.0,ACTUAL,University of Pittsburgh,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,OTHER,,,,,,,2022,1.0
NCT04162470,,2019-11-11,2023-04-04,,2023-05-17,2019-11-11,2019-11-14,ACTUAL,2023-05-17,2023-06-12,ACTUAL,,,,2023-05-17,2023-06-12,ACTUAL,2019-12-03,ACTUAL,2019-12-03,2023-05,2023-05-31,2022-04-07,ACTUAL,2022-04-07,2022-04-07,ACTUAL,2022-04-07,,INTERVENTIONAL,,Safety Analysis Set (SAF) included all enrolled participants who received any study drug.,"REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate Its Long Term Safety, Efficacy and Tolerability.","An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria",TERMINATED,,PHASE3,24.0,ACTUAL,Regeneron Pharmaceuticals,,1.0,,Business Decision,f,,,,,t,f,,,t,,,"Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.","Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency \[EMA\], Pharmaceuticals and Medical Devices Agency \[PMDA\], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).",https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,INDUSTRY,,,,,,,2022,0.0
NCT02917772,,2016-09-27,,,2022-10-05,2016-09-27,2016-09-28,ESTIMATED,,,,,,,2022-10-05,2022-10-06,ACTUAL,2016-10,ACTUAL,2016-10-31,2022-10,2022-10-31,2022-10,ACTUAL,2022-10-31,2021-10,ACTUAL,2021-10-31,,INTERVENTIONAL,TITAN-RCC,,Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma,A Phase II Single Arm Clinical Trial of a Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma,COMPLETED,,PHASE2,200.0,ACTUAL,AIO-Studien-gGmbH,,1.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,OTHER,,,,,,,2022,1.0
NCT04729348,,2021-01-25,,,2024-03-14,2021-01-25,2021-01-28,ACTUAL,,,,,,,2024-03-14,2024-03-15,ACTUAL,2021-03-08,ACTUAL,2021-03-08,2024-03,2024-03-31,2024-01-17,ACTUAL,2024-01-17,2024-01-17,ACTUAL,2024-01-17,,INTERVENTIONAL,,,Pembrolizumab And Lenvatinib In Leptomeningeal Metastases,Phase II Trial of Pembrolizumab and Lenvatinib for Leptomeningeal Metastases,TERMINATED,,PHASE2,10.0,ACTUAL,Massachusetts General Hospital,,1.0,,Planned interim analysis,f,,,,t,t,f,,,t,,,Data can be shared no earlier than 1 year following the date of publication,Contact the Partners Innovations team at http://www.partners.org/innovation,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,OTHER,,,,,,,2024,0.0
NCT04433767,,2020-06-12,2023-10-06,,2023-11-09,2020-06-12,2020-06-16,ACTUAL,2023-11-09,2023-12-06,ACTUAL,,,,2023-11-09,2023-12-06,ACTUAL,2020-12-15,ACTUAL,2020-12-15,2023-11,2023-11-30,2022-10-07,ACTUAL,2022-10-07,2022-10-07,ACTUAL,2022-10-07,,INTERVENTIONAL,DepMIND2,,Depressed Mood Improvement Through Nicotine Dosing 2,Nicotinic Modulation of the Cognitive Control System in Late-life Depression,COMPLETED,,PHASE2,29.0,ACTUAL,Vanderbilt University Medical Center,"Small, open-label study design",1.0,,,f,,,,t,t,f,,,f,,,"Data will be shared according to policies from the NDCT and the NIMH Data Archive (NDA). Descriptive data, outcome measures and analyzed data will be shared will be shared within 4 months of when a publication is accepted. Study data will be shared through the NDCT indefinitely.","The NIH will provide access to scientific investigators for research purposes. Qualified researchers who have completed a Data Use Certification and received approval from the NDA Data Access Committee (DAC) may be approved to access broadly shared data. A separate request process exists for access to data in federated sources. Additionally, the DAC and support staff at NIH have access to NDA shared data.",https://nda.nih.gov,YES,"This study will include clinical, cognitive, and neuroimaging data from older depressed subjects. The final dataset will include clinical information about subject psychiatric diagnoses, psychiatric and medical history, cognitive data, and response to transdermal nicotine. We will share data via the National Database for Clinical Trials related to Mental Illness (NDCT). NDCT provides a secure platform for data-sharing allowing for communication of research data, tools, and supporting documents. As required by NDCT, we will obtain a Global Unique Identifier (GUID) for each participant. We will additionally follow NDCT requirements to certify and review data, as well as timeline requirements for data submission and data sharing. Sharing of neuroimaging data will also be facilitated by an XNAT system (xnat.org). XNAT is an open-source informatics software platform that assists in the management and archiving of imaging data.",2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,OTHER,,,,,,,2022,1.0
NCT03087708,,2017-03-16,2022-05-02,,2023-04-10,2017-03-16,2017-03-22,ACTUAL,2022-07-11,2022-08-03,ACTUAL,,,,2023-04-10,2023-05-06,ACTUAL,2017-10-13,ACTUAL,2017-10-13,2023-04,2023-04-30,2023-04-01,ACTUAL,2023-04-01,2021-01-04,ACTUAL,2021-01-04,,INTERVENTIONAL,,,Naloxegol in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer,"A Randomized, Double-Blind, Placebo-Controlled Pilot Study of an Oral, Selective Peripheral Opioid Receptor Antagonist in Advanced Non-Small Cell Lung Cancer",TERMINATED,,PHASE2,50.0,ACTUAL,Alliance for Clinical Trials in Oncology,,3.0,,Insufficient accrual,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,OTHER,,,,,,,2023,0.0
NCT04891913,,2021-05-10,,,2022-06-20,2021-05-17,2021-05-19,ACTUAL,,,,,,,2022-06-20,2022-06-27,ACTUAL,2023-07-01,ESTIMATED,2023-07-01,2022-06,2022-06-30,2023-12-25,ESTIMATED,2023-12-25,2023-12-25,ESTIMATED,2023-12-25,,INTERVENTIONAL,,,SY007 in Patients With Acute Ischemic Stroke,"Phase Ib Clinical Study to Evaluate Safety, Tolerance，Pharmacokinetics and Efficacy of SY-007 After Intravenous Injection in Acute Ischemic Stroke Subjects",SUSPENDED,,PHASE1,36.0,ESTIMATED,"Suzhou Yabao Pharmaceutical R&D Co., Ltd.",,3.0,,The sponsor decided to suspend the process,f,,,,,f,f,,,,,,,,,,,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,INDUSTRY,,,,,,,2023,0.0
NCT04518293,,2020-08-15,,,2024-04-24,2020-08-15,2020-08-19,ACTUAL,,,,,,,2024-04-24,2024-04-25,ACTUAL,2021-06-26,ACTUAL,2021-06-26,2024-04,2024-04-30,2023-09-01,ACTUAL,2023-09-01,2023-08-01,ACTUAL,2023-08-01,,INTERVENTIONAL,GMRx2_ACT,,Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension,Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Dual Combinations for the Treatment of Hypertension,COMPLETED,,PHASE3,1385.0,ACTUAL,George Medicines PTY Limited,,4.0,,,f,,,,t,t,f,,,,,,,,,NO,"If the sponsor receives a request for study data, then such requests will be reviewed by sponsor following completion of regulatory submissions and review, and with support from members of the GMRX2 steering committee who will advise on the scientific merit and integrity of the proposed analysis.",2024-10-16 19:45:25.709733,2024-10-16 19:45:25.709733,INDUSTRY,,,,,,,2023,1.0
NCT03382912,,2017-12-18,2020-08-22,,2020-08-22,2017-12-21,2017-12-26,ACTUAL,2020-08-22,2020-09-11,ACTUAL,,,,2020-08-22,2020-09-11,ACTUAL,2018-03-22,ACTUAL,2018-03-22,2020-06,2020-06-30,2020-03-03,ACTUAL,2020-03-03,2019-08-28,ACTUAL,2019-08-28,,INTERVENTIONAL,Cypress 2,All randomized participants.,Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer,A Randomized Phase 2 Trial of AM0010 in Combination With Nivolumab vs. Nivolumab Alone as Second-Line Therapy in Subjects With Stage IV / Metastatic Wild Type Non-Small Cell Lung Cancer and Low Tumor Expression of PD-L1,TERMINATED,,PHASE2,52.0,ACTUAL,Eli Lilly and Company,,2.0,,The CYPRESS-2 trial was closed early after the planned final analysis because the risk benefit ratio is unfavorable.,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://www.clinicalstudydatarequest.com,YES,Yes~Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,INDUSTRY,,,,,,,2020,0.0
NCT03550313,,2018-05-25,2021-10-20,,2021-11-29,2018-05-25,2018-06-08,ACTUAL,2021-11-29,2021-11-30,ACTUAL,,,,2021-11-29,2021-11-30,ACTUAL,2018-06-01,ACTUAL,2018-06-01,2021-11,2021-11-30,2020-11-05,ACTUAL,2020-11-05,2020-11-05,ACTUAL,2020-11-05,,INTERVENTIONAL,,The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study.,Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants,"A PHASE 2, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN WITH, OR SEPARATELY FROM, 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS",TERMINATED,,PHASE2,565.0,ACTUAL,Pfizer,,3.0,,Study vaccinations and blood draws were halted due to adequacy of a smaller dataset and study feasibility issues. It was not based on any safety concerns.,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,INDUSTRY,,,,,,,2020,0.0
NCT05814523,,2023-04-03,,,2024-05-10,2023-04-03,2023-04-18,ACTUAL,,,,,,,2024-05-10,2024-05-14,ACTUAL,2024-03,ESTIMATED,2024-03-31,2024-05,2024-05-31,2024-08,ESTIMATED,2024-08-31,2024-08,ESTIMATED,2024-08-31,,INTERVENTIONAL,,,"To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)","A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus",WITHDRAWN,,PHASE3,0.0,ACTUAL,Marinus Pharmaceuticals,,2.0,,Business reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,INDUSTRY,,,,,,,2024,0.0
NCT04728646,,2021-01-21,,,2021-12-14,2021-01-26,2021-01-28,ACTUAL,,,,,,,2021-12-14,2022-01-05,ACTUAL,2021-09,ESTIMATED,2021-09-30,2021-12,2021-12-31,2021-12-13,ACTUAL,2021-12-13,2021-12-13,ACTUAL,2021-12-13,,INTERVENTIONAL,,,Evaluation of Dextenza in Patients With Ocular GVHD and Effects on Ocular Surface Disease Outcomes,Evaluation of Dextenza in Patients With Ocular Graft Vs Host Disease (GVHD) and Effect on Ocular Surface Disease Outcomes.,WITHDRAWN,,PHASE4,0.0,ACTUAL,Massachusetts Eye and Ear Infirmary,,2.0,,Due to difficulty enrolling subjects whom had not meet the inclusion criteria,f,,,,f,t,f,,,t,,,,,,,,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,OTHER,,,,,,,2021,0.0
NCT04378244,,2020-05-04,,,2023-08-02,2020-05-05,2020-05-07,ACTUAL,,,,,,,2023-08-02,2023-08-04,ACTUAL,2022-12-12,ESTIMATED,2022-12-12,2023-08,2023-08-31,2024-07-12,ESTIMATED,2024-07-12,2023-12-12,ESTIMATED,2023-12-12,,INTERVENTIONAL,CORONA,,CORONA: A Study Using DeltaRex-G Gene Therapy for Symptomatic COVID-19,CORONA: A Phase 1/2 Study Using DeltaRex-G Gene Therapy for Symptomatic COVID-19,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Aveni Foundation,,1.0,,Lack of Funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:07:01.598926,2024-10-15 13:07:01.598926,OTHER,,,,,,,2024,0.0
NCT03132155,,2017-04-20,2024-04-05,,2024-05-22,2017-04-26,2017-04-27,ACTUAL,2024-05-22,2024-05-24,ACTUAL,,,,2024-05-22,2024-05-24,ACTUAL,2018-08-29,ACTUAL,2018-08-29,2024-05,2024-05-31,2021-09-21,ACTUAL,2021-09-21,2021-08-13,ACTUAL,2021-08-13,,INTERVENTIONAL,,,QUILT-3.031: AMG 337 in Subjects With Advanced or Metastatic Clear Cell Sarcoma,A Phase 2 Study of AMG 337 in Subjects With Advanced or Metastatic Clear Cell Sarcoma That Contains the Ewing Sarcoma Breakpoint Region 1-activating Transcription Factor-1 (EWSR1-ATF1) Gene Fusion,TERMINATED,,PHASE2,8.0,ACTUAL,"NantPharma, LLC",The study was terminated early due to low enrollment. Only the safety data is provided.,1.0,,Prematurely terminated due to lack of therapeutic effect,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:45:25.709733,2024-10-16 19:45:25.709733,INDUSTRY,,,,,,,2021,0.0
NCT04554459,,2020-09-04,,,2024-08-13,2020-09-14,2020-09-18,ACTUAL,,,,,,,2024-08-13,2024-08-14,ACTUAL,2021-02-16,ACTUAL,2021-02-16,2023-08,2023-08-31,2024-07-01,ACTUAL,2024-07-01,2023-09-01,ACTUAL,2023-09-01,,INTERVENTIONAL,Pona-CELL,,Ponatinib Plus Reduced-intensity Chemotherapy in the First-line Treatment of Adult Patients With Ph+ ALL,Ponatinib Plus Reduced-intensity Chemotherapy in the First-line Treatment of Adult Patients With Ph-positive Acute Lymphoblastic Leukemia,TERMINATED,,PHASE2,4.0,ACTUAL,"Institute of Hematology and Blood Transfusion, Czech Republic",,1.0,,slower recruitment rate;,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,OTHER,,,,,,,2024,0.0
NCT05542446,,2022-08-18,,,2024-01-29,2022-09-14,2022-09-15,ACTUAL,,,,,,,2024-01-29,2024-01-31,ACTUAL,2022-09-01,ACTUAL,2022-09-01,2024-01,2024-01-31,2024-01-19,ACTUAL,2024-01-19,2024-01-19,ACTUAL,2024-01-19,,INTERVENTIONAL,COL-ECMO2022,,Pharmacokinetics of Colistin in Critically Ill Patients With Extracorporeal Membrane Oxygenation,Pharmacokinetics of Colistin in Critically Ill Patients With Extracorporeal Membrane Oxygenation,TERMINATED,,PHASE4,8.0,ACTUAL,"St. Anne's University Hospital Brno, Czech Republic",,2.0,,"After agreement between sponsor and investigator, insufficient patients recruitment",f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,OTHER,,,,,,,2024,0.0
NCT04636567,,2020-11-11,,,2021-06-30,2020-11-16,2020-11-19,ACTUAL,,,,,,,2021-06-30,2021-07-02,ACTUAL,2021-03,ESTIMATED,2021-03-31,2020-11,2020-11-30,2021-12,ESTIMATED,2021-12-31,2021-07,ESTIMATED,2021-07-31,,INTERVENTIONAL,,,Open-label Study to Evaluate Nerindocianine as a Surgical Aid in Ureter Delineation During Minimally Invasive Surgery,A Phase 2 Open-label Study to Evaluate the Use of Nerindocianine as a Surgical Aid in the Delineation of Abdominopelvic Ureter Anatomy Via Near-infrared Fluorescence Imaging in the Setting of Minimally Invasive Surgery,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Li-Cor, Inc.",,1.0,,Clinical program has been suspended for business reasons.,f,,,,t,t,f,,,,,,,,,NO,There is no plan to make individual participant data (IPD) available.,2024-10-14 22:38:08.441998,2024-10-14 22:38:08.441998,INDUSTRY,,,,,,,2021,0.0
NCT04365660,,2020-04-24,2023-09-28,,2023-10-26,2020-04-24,2020-04-28,ACTUAL,2023-10-26,2023-11-14,ACTUAL,,,,2023-10-26,2023-11-14,ACTUAL,2021-01-28,ACTUAL,2021-01-28,2023-10,2023-10-31,2021-07-22,ACTUAL,2021-07-22,2021-05-28,ACTUAL,2021-05-28,,INTERVENTIONAL,,,18F-FTC-146 PET/CT in Newly-Diagnosed Osteosarcoma,A Phase 2 Study of 18F FTC 146 PET/CT in Patients With Newly Diagnosed Osteosarcoma,TERMINATED,,PHASE2,1.0,ACTUAL,Stanford University,,1.0,,lack of accrual with no intent of continuing,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,OTHER,,,,,,,2021,0.0
NCT04634604,,2020-11-16,2024-06-24,,2024-07-29,2020-11-16,2020-11-18,ACTUAL,2024-07-29,2024-08-01,ACTUAL,,,,2024-07-29,2024-08-01,ACTUAL,2022-04-27,ACTUAL,2022-04-27,2024-07,2024-07-31,2023-08-14,ACTUAL,2023-08-14,2023-08-14,ACTUAL,2023-08-14,,INTERVENTIONAL,ROP3,,A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP,A Randomized Trial of Low-Dose Bevacizumab Versus Laser for Type 1 Retinopathy of Prematurity,TERMINATED,,PHASE3,16.0,ACTUAL,Jaeb Center for Health Research,Early termination leading to small numbers of subjects which precluded statistical analysis. Active participants were released from study at time of study termination.,2.0,,Lack of feasibility to recruit.,f,,,,t,t,f,,,,,,Data will be made available after publication of each primary manuscript.,Users accessing the data must enter an email address.,,YES,"Yes In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the Pediatric Eye Disease Investigator Group (PEDIG) public website after the completion of each protocol and publication of the primary manuscript.",2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,OTHER,,,,,,,2023,0.0
NCT03043313,,2017-01-31,2023-01-27,,2023-11-09,2017-02-02,2017-02-06,ESTIMATED,2023-03-27,2023-04-18,ACTUAL,,,,2023-11-09,2023-11-13,ACTUAL,2017-06-23,ACTUAL,2017-06-23,2023-11,2023-11-30,2023-11-02,ACTUAL,2023-11-02,2022-03-28,ACTUAL,2022-03-28,,INTERVENTIONAL,,The Full Analysis Set includes all subjects who were enrolled and received any amount of study treatment and had HER2+ tumors as defined by one or more protocol required local tests.,Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer,"MOUNTAINEER: A Phase II, Open Label Study of Tucatinib Combined With Trastuzumab in Patients With HER2+ Metastatic Colorectal Cancer",COMPLETED,,PHASE2,117.0,ACTUAL,Seagen Inc.,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,INDUSTRY,,,,,,,2023,1.0
NCT04365231,,2020-04-23,,,2020-11-18,2020-04-27,2020-04-28,ACTUAL,,,,,,,2020-11-18,2020-11-20,ACTUAL,2020-04-01,ACTUAL,2020-04-01,2020-11,2020-11-30,2021-04-01,ESTIMATED,2021-04-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,HASCOPT,,Hydroxychloroquine Azithromycin COVID-19 Pregnancy Trial,Efficacy Evaluation of Hydroxychloroquine Azithromycin in the Treatment of COVID-19 in Pregnant Women: an Open-label Randomized Clinical Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,"Hospital St. Joseph, Marseille, France",,2.0,,no authorization obtained,f,,,,,f,f,,,f,,,,,,NO,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,OTHER,,,,,,,2021,0.0
NCT02954991,,2016-11-02,2024-01-26,2022-11-01,2024-04-10,2016-11-02,2016-11-04,ESTIMATED,2024-04-10,2024-04-22,ACTUAL,2022-11-01,2022-11-04,ACTUAL,2024-04-10,2024-04-22,ACTUAL,2016-11-07,ACTUAL,2016-11-07,2024-04,2024-04-30,2021-11-04,ACTUAL,2021-11-04,2021-11-04,ACTUAL,2021-11-04,,INTERVENTIONAL,,"The Safety Population was defined as all participants who received at least 1 dose of any study treatment (sitravatinib, glesatinib, or nivolumab). 1 participant has been excluded from the analysis as the PD-L1 status could not be confirmed due to a missing laboratory sample.","Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer","A Parallel Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Advanced or Metastatic Non-Small Cell Lung Cancer",TERMINATED,,PHASE2,161.0,ACTUAL,Mirati Therapeutics Inc.,Enrollment into glesatinib cohorts was discontinued in November 2017 as a result of Sponsor portfolio reprioritization. The analysis and reporting of this treatment arm is limited and will be summarized for selected tables only.,3.0,,This study was terminated as a result of Sponsor portfolio reprioritization.,f,,,,f,,,,,,,,,,,NO,,2024-10-16 19:45:25.709733,2024-10-16 19:45:25.709733,INDUSTRY,,,,,,,2021,0.0
NCT05152303,,2021-11-29,,,2023-05-22,2021-11-29,2021-12-09,ACTUAL,,,,,,,2023-05-22,2023-05-23,ACTUAL,2022-10-12,ACTUAL,2022-10-12,2023-04,2023-04-30,2023-04-19,ACTUAL,2023-04-19,2023-04-02,ACTUAL,2023-04-02,,INTERVENTIONAL,,,A Study of Remimazolam Tosilate for Sedation in the ICU,"Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU) - a Multicenter, Randomized, Single Blind, Dose Finding Phase II Clinical Trial",COMPLETED,,PHASE2,60.0,ACTUAL,"Fujian Shengdi Pharmaceutical Co., Ltd.",,2.0,,,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,INDUSTRY,,,,,,,2023,1.0
NCT02274155,,2014-10-14,,,2024-02-06,2014-10-22,2014-10-24,ESTIMATED,,,,,,,2024-02-06,2024-02-07,ACTUAL,2014-11-12,ACTUAL,2014-11-12,2024-02,2024-02-29,2023-12-21,ACTUAL,2023-12-21,2017-09-17,ACTUAL,2017-09-17,,INTERVENTIONAL,,,Anti-OX40 Antibody in Head and Neck Cancer Patients,"Phase Ib Study of a Monoclonal Antibody to OX40 (MEDI6469) Administered Prior to Definitive Surgical Resection Patients With Locoregionally Advanced, Oral Head and Neck Squamous Cell Carcinoma",COMPLETED,,PHASE1,17.0,ACTUAL,Providence Health & Services,,3.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,OTHER,,,,,,,2023,1.0
NCT04423068,,2020-06-05,,,2023-04-03,2020-06-05,2020-06-09,ACTUAL,,,,,,,2023-04-03,2023-04-05,ACTUAL,2020-12-10,ACTUAL,2020-12-10,2023-04,2023-04-30,2023-04-04,ACTUAL,2023-04-04,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,,,Inpatient Adolescent Contraception,Intervention to Facilitate Contraception Provision by Pediatric Hospitalists: A Feasibility Study,COMPLETED,,EARLY_PHASE1,25.0,ACTUAL,Children's Mercy Hospital Kansas City,,1.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,OTHER,,,,,,,2023,1.0
NCT03599518,,2018-07-16,2021-09-14,,2022-05-13,2018-07-16,2018-07-26,ACTUAL,2022-05-13,2023-02-08,ACTUAL,,,,2022-05-13,2023-02-08,ACTUAL,2018-09-21,ACTUAL,2018-09-21,2022-05,2022-05-31,2020-06-29,ACTUAL,2020-06-29,2020-04-22,ACTUAL,2020-04-22,,INTERVENTIONAL,,Demographic and baseline characteristics were assessed in the Full Analysis Set.,DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer,"A Multicenter, Open-Label Phase 1 Study of DS-1205c in Combination With Gefitinib in Subjects With Metastatic or Unresectable EGFR-Mutant Non-Small Cell Lung Cancer",TERMINATED,,PHASE1,20.0,ACTUAL,Daiichi Sankyo,The sponsor decided to terminate the study at the end of the Dose Escalation part and the Dose Expansion part was not conducted.,1.0,,This study was terminated based on a business decision by the Sponsor.,f,,,,t,f,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-14 22:43:57.941745,2024-10-14 22:43:57.941745,INDUSTRY,,,,,,,2020,0.0
NCT02830594,,2016-05-18,2022-01-25,,2024-02-14,2016-07-08,2016-07-13,ESTIMATED,2022-06-06,2022-06-30,ACTUAL,,,,2024-02-14,2024-02-20,ACTUAL,2016-10-05,ACTUAL,2016-10-05,2024-02,2024-02-29,2024-01-16,ACTUAL,2024-01-16,2022-01-20,ACTUAL,2022-01-20,,INTERVENTIONAL,,,"Pembrolizumab and Palliative Radiation Therapy in Treating Patients With Metastatic Esophagus, Stomach, or Gastroesophageal Junction Cancer",Combining Pembrolizumab and Palliative Radiotherapy in Gastroesophageal Cancer to Enhance Anti-Tumor T Cell Response and Augment the Abscopal Effect,COMPLETED,,PHASE2,14.0,ACTUAL,City of Hope Medical Center,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,OTHER,,,,,,,2024,1.0
NCT04956302,,2021-06-30,,,2024-06-04,2021-06-30,2021-07-09,ACTUAL,,,,,,,2024-06-04,2024-06-06,ACTUAL,2021-09-27,ACTUAL,2021-09-27,2024-06,2024-06-30,2022-06-16,ACTUAL,2022-06-16,2022-06-16,ACTUAL,2022-06-16,,INTERVENTIONAL,,,"Panobinostat in Combination With Daratumumab, Bortezomib and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma","A Phase I Study of Panobinostat in Combination With Daratumumab, Bortezomib, and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma",TERMINATED,,PHASE1,1.0,ACTUAL,Ohio State University Comprehensive Cancer Center,,1.0,,PI Decision,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,OTHER,,,,,,,2022,0.0
NCT05013437,,2021-08-13,,,2024-04-01,2021-08-13,2021-08-19,ACTUAL,,,,,,,2024-04-01,2024-04-02,ACTUAL,2023-09,ESTIMATED,2023-09-30,2024-04,2024-04-30,2024-03,ESTIMATED,2024-03-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,AHCT,,Melphalan on Disease Burden Measured by Next Generation Sequencing Before AHCT (Autologous Hematopoietic Cell Transplant) for Multiple Myeloma,A Pilot Study to Assess Impact of Low Dose Melphalan on Disease Burden Measured by Next Generation Sequencing Before Autologous Hematopoietic Cell Transplant (AHCT) for Multiple Myeloma Patients,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Case Comprehensive Cancer Center,,1.0,,The original principal Investigator left the institution.,,,,,t,t,f,,,,,,,,,YES,All individual participant data (IPD) that underlie results in publication,2024-10-16 19:45:25.709733,2024-10-16 19:45:25.709733,OTHER,,,,,,,2024,0.0
NCT05393999,,2021-09-01,,,2023-04-21,2022-05-24,2022-05-27,ACTUAL,,,,,,,2023-04-21,2023-04-24,ACTUAL,2021-11-29,ACTUAL,2021-11-29,2023-04,2023-04-30,2022-03-04,ACTUAL,2022-03-04,2022-03-04,ACTUAL,2022-03-04,,INTERVENTIONAL,SABRE,,SABRE: A Single-arm Prospective Study Measuring Safety and Tolerability of SARS-CoV-2 Neutralising Antibodies in High-risk Populations,"The SABRE Trial: A Single-arm Prospective Study Measuring Safety, Tolerability and Pharmacokinetics of Two SARS-CoV-2 Neutralising Antibodies (C135-LS and C144-LS) Amongst High-risk Special Populations of Vaccine Non-responders.",WITHDRAWN,,PHASE2,0.0,ACTUAL,Imperial College Healthcare NHS Trust,,1.0,,"The drug was found to be ineffective against Omicron, so the study was terminated and no patients were enrolled.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 22:43:57.941745,2024-10-14 22:43:57.941745,OTHER,,,,,,,2022,0.0
NCT03981744,,2019-06-07,2023-01-20,,2023-12-01,2019-06-07,2019-06-11,ACTUAL,2023-12-01,2024-05-13,ACTUAL,,,,2023-12-01,2024-05-13,ACTUAL,2019-07-26,ACTUAL,2019-07-26,2023-11,2023-11-30,2022-07-12,ACTUAL,2022-07-12,2022-01-24,ACTUAL,2022-01-24,,INTERVENTIONAL,,,A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments,"A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments",TERMINATED,,PHASE3,51.0,ACTUAL,Janssen Pharmaceutical K.K.,This study was terminated early due to lack of efficacy found at Week 24.,2.0,,The study did not meet the primary endpoint.,f,,,,t,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu",2024-10-14 22:43:57.941745,2024-10-14 22:43:57.941745,INDUSTRY,,,,,,,2022,0.0
NCT03675022,,2018-07-18,,,2022-10-04,2018-09-14,2018-09-18,ACTUAL,,,,,,,2022-10-04,2022-10-05,ACTUAL,2018-08-15,ACTUAL,2018-08-15,2022-10,2022-10-31,2022-07-01,ACTUAL,2022-07-01,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,,,Effect of Dupilumab on Sleep Apnea in Patients With Rhinosinusitis,Effect of Dupilumab on Sleep Apnea Severity in Patients With Chronic Rhinosinusitis,TERMINATED,,EARLY_PHASE1,9.0,ACTUAL,Brigham and Women's Hospital,,1.0,,Inability to recruit during COVID,f,,,,,t,f,,,t,,,,,,,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,OTHER,,,,,,,2022,0.0
NCT05679492,,2023-01-10,,,2023-09-14,2023-01-10,2023-01-11,ACTUAL,,,,,,,2023-09-14,2023-09-15,ACTUAL,2023-05-30,ESTIMATED,2023-05-30,2023-01,2023-01-31,2023-12-01,ESTIMATED,2023-12-01,2023-09-01,ESTIMATED,2023-09-01,,INTERVENTIONAL,,,Study on the Safety and Efficacy of Meplazumab for Injection Patients COVID-19,"A Multicenter, Randomized, Double-blind, Placebo-controlled, add-on Phase III Clinical Study on the Efficacy and Safety of Meplazumab for Injection in Adults With Mild and Moderate COVID-19 Infections",WITHDRAWN,,PHASE3,0.0,ACTUAL,Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd,,2.0,,"Based on current epidemic situation in China, there is few Mild and Moderate COVID-19 patients.",f,,,,,f,f,,,,,,,,,,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,INDUSTRY,,,,,,,2023,0.0
NCT04029922,,2019-07-19,,,2023-06-15,2019-07-19,2019-07-23,ACTUAL,,,,,,,2023-06-15,2023-06-18,ACTUAL,2019-11-12,ACTUAL,2019-11-12,2023-06,2023-06-30,2023-04-27,ACTUAL,2023-04-27,2023-02-01,ACTUAL,2023-02-01,,INTERVENTIONAL,MT-5111,,Study of MT-5111 in HER2-positive Solid Tumors,"A Phase 1 Open-label, Multicenter Dose Escalation and Expansion Study of MT-5111 in Subjects With Previously Treated Advanced HER2-positive Solid Tumors",TERMINATED,,PHASE1,50.0,ACTUAL,"Molecular Templates, Inc.",,2.0,,Study Reprioritization,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,INDUSTRY,,,,,,,2023,0.0
NCT05536882,,2022-09-07,,,2024-03-04,2022-09-07,2022-09-13,ACTUAL,,,,,,,2024-03-04,2024-03-06,ACTUAL,2022-05-18,ACTUAL,2022-05-18,2024-03,2024-03-31,2023-10-09,ACTUAL,2023-10-09,2023-10-09,ACTUAL,2023-10-09,,INTERVENTIONAL,,,MC RCT - BPO vs Adapalene,Randomized Controlled Trial Comparing the Efficacy of Adapalene 0.1% Gel to 10% Benzoyl Peroxide in Treating Molluscum Contagiosum.,WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Oklahoma,,2.0,,The original PI left the institution prior to final IRB approval and the remaining study team did not have the resources to continue.,f,,,,,t,f,,,,,,,,,NO,,2024-10-14 22:43:57.941745,2024-10-14 22:43:57.941745,OTHER,,,,,,,2023,0.0
NCT04757376,,2021-02-12,2024-04-19,,2024-05-20,2021-02-12,2021-02-17,ACTUAL,2024-04-19,2024-05-16,ACTUAL,,,,2024-05-20,2024-06-14,ACTUAL,2021-06-17,ACTUAL,2021-06-17,2024-05,2024-05-31,2023-11-16,ACTUAL,2023-11-16,2023-05-18,ACTUAL,2023-05-18,,INTERVENTIONAL,,"The overall number of participants analyzed represents the Intent-to-treat (ITT) Set. The ITT set was defined as all participants randomly assigned to receive study drug (CT-P41 or US-Prolia), regardless of whether or not any study drug was administered.",A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis,"A Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis",COMPLETED,,PHASE3,479.0,ACTUAL,Celltrion,,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,INDUSTRY,,,,,,,2023,1.0
NCT03666988,,2018-09-10,2022-03-01,,2022-03-01,2018-09-10,2018-09-12,ACTUAL,2022-03-01,2022-05-20,ACTUAL,,,,2022-03-01,2022-05-20,ACTUAL,2018-10-22,ACTUAL,2018-10-22,2022-02,2022-02-28,2021-03-04,ACTUAL,2021-03-04,2021-03-04,ACTUAL,2021-03-04,,INTERVENTIONAL,,"Study was terminated early during Part 1 as the benefit/risk assessment did not favor continuation of the study, therefore Part 1: Food effect cohorts and Part 2 were not conducted.",First Time in Humans (FTIH) Study of GSK3368715 in Participants With Solid Tumors and Diffuse Large B-cell Lymphoma (DLBCL),"A Phase I, Open-label, Dose-escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3368715 in Participants With Solid Tumors and DLBCL",TERMINATED,,PHASE1,31.0,ACTUAL,GlaxoSmithKline,,5.0,,Overall benefit-risk profile did not support continuation of the study,f,,,,f,t,f,,,,,,IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-14 22:43:57.941745,2024-10-14 22:43:57.941745,INDUSTRY,,,,,,,2021,0.0
NCT03836287,,2019-02-06,2024-03-14,2022-01-21,2024-05-10,2019-02-07,2019-02-11,ACTUAL,2024-05-10,2024-06-06,ACTUAL,,2024-06-06,ACTUAL,2024-05-10,2024-06-06,ACTUAL,2020-10-09,ACTUAL,2020-10-09,2024-05,2024-05-31,2021-06-25,ACTUAL,2021-06-25,2021-06-25,ACTUAL,2021-06-25,,INTERVENTIONAL,CardiganI,,Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301),"A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied Sofpironium Bromide Gel, 15% in Subjects With Axillary Hyperhidrosis",COMPLETED,,PHASE3,350.0,ACTUAL,Botanix Pharmaceuticals,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,INDUSTRY,,,,,,,2021,1.0
NCT02601313,,2015-11-06,2020-08-21,2020-07-17,2024-02-08,2015-11-06,2015-11-10,ESTIMATED,2020-08-21,2020-09-10,ACTUAL,2020-07-17,2020-07-21,ACTUAL,2024-02-08,2024-02-12,ACTUAL,2015-11-09,ACTUAL,2015-11-09,2024-02,2024-02-29,2023-09-22,ACTUAL,2023-09-22,2019-07-24,ACTUAL,2019-07-24,,INTERVENTIONAL,ZUMA-2,The Safety Analysis Set included all participants treated with any dose of anti-CD19 CAR T cells.,Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2),A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma,COMPLETED,,PHASE2,105.0,ACTUAL,Gilead Sciences,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,INDUSTRY,,,,,,,2023,1.0
NCT04364815,,2020-04-22,,,2020-11-04,2020-04-24,2020-04-28,ACTUAL,,,,,,,2020-11-04,2020-11-06,ACTUAL,2020-12,ESTIMATED,2020-12-31,2020-11,2020-11-30,2021-05,ESTIMATED,2021-05-31,2021-05,ESTIMATED,2021-05-31,,INTERVENTIONAL,,,The University of the Philippines Hydroxychloroquine PEP Against COVID-19 Trial,"Efficacy and Safety of Hydroxychloroquine for COVID-19 Post-Exposure Prophylaxis of Healthcare Workers in the Philippine General Hospital and UP Manila National Institutes of Health: A Randomized, Double-blind, Placebo-controlled Trial",WITHDRAWN,,PHASE3,0.0,ACTUAL,University of the Philippines,,2.0,,Investigators opted to change the design of the study.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 22:43:57.941745,2024-10-14 22:43:57.941745,OTHER,,,,,,,2021,0.0
NCT02697253,,2016-02-23,,,2022-11-14,2016-02-26,2016-03-03,ESTIMATED,,,,,,,2022-11-14,2022-11-15,ACTUAL,2016-01,,2016-01-31,2022-11,2022-11-30,2021-07-29,ACTUAL,2021-07-29,2021-07-29,ACTUAL,2021-07-29,,INTERVENTIONAL,,,Mechanisms Underlying Predictors of Success From Obesity Surgery,Mechanisms Underlying Predictors of Success From Obesity Surgery,WITHDRAWN,,PHASE2,0.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,4.0,,,,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,OTHER,,,,,,,2021,0.0
NCT04096560,,2019-09-18,,2022-10-05,2023-03-27,2019-09-18,2019-09-20,ACTUAL,,,,2022-10-05,2022-10-10,ACTUAL,2023-03-27,2023-04-03,ACTUAL,2020-02-27,ACTUAL,2020-02-27,2023-03,2023-03-31,2021-11-05,ACTUAL,2021-11-05,2021-11-05,ACTUAL,2021-11-05,,INTERVENTIONAL,,,A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy,"A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 or Narcolepsy Type 2)",TERMINATED,,PHASE2,257.0,ACTUAL,Takeda,,14.0,,"A safety signal has emerged in Phase 2 studies of TAK-994. As an immediate precautionary measure, Takeda has suspended dosing of patients and has decided to stop Phase 2 studies early.",f,,,,,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,INDUSTRY,,,,,,,2021,0.0
NCT04339413,,2020-04-07,2023-12-21,,2023-12-21,2020-04-07,2020-04-09,ACTUAL,2023-12-21,2024-01-18,ACTUAL,,,,2023-12-21,2024-01-18,ACTUAL,2020-05-22,ACTUAL,2020-05-22,2023-12,2023-12-31,2023-01-04,ACTUAL,2023-01-04,2023-01-04,ACTUAL,2023-01-04,,INTERVENTIONAL,,Intent to treat (ITT) population included all the participants who were enrolled in the study.,A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD),"An Open-Label, Multicenter, Rollover Study to Evaluate the Safety and Tolerability of Long-Term Administration of Gantenerumab in Participants With Alzheimer's Disease",TERMINATED,,PHASE3,116.0,ACTUAL,Hoffmann-La Roche,,2.0,,Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I\&II (WN29922/WN39658).,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-14 22:43:57.941745,2024-10-14 22:43:57.941745,INDUSTRY,,,,,,,2023,0.0
NCT02605356,,2015-11-12,,,2016-10-06,2015-11-12,2015-11-16,ESTIMATED,,,,,,,2016-10-06,2016-10-07,ESTIMATED,2016-10,,2016-10-31,2016-09,2016-09-30,2021-07,ESTIMATED,2021-07-31,2019-11,ESTIMATED,2019-11-30,,INTERVENTIONAL,,,Phase 1b/2 Study Testing Radium-223 Dichloride/Bortezomib/Dexamethasone Combination in Relapsed Multiple Myeloma,A Phase 1b/2 Trial to Evaluate the Safety and Efficacy of Radium-223 Dichloride (BAY88-8223) in Combination With Bortezomib and Dexamethasone in Early Relapsed Multiple Myeloma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Bayer,,5.0,,Study restarted under new study number 18987,f,,,,t,,,,,,,,,,,,,2024-10-14 22:43:57.941745,2024-10-14 22:43:57.941745,INDUSTRY,,,,,,,2021,0.0
NCT03886493,,2019-03-20,2021-09-17,,2021-09-17,2019-03-20,2019-03-22,ACTUAL,2021-09-17,2021-10-15,ACTUAL,,,,2021-09-17,2021-10-15,ACTUAL,2019-08-28,ACTUAL,2019-08-28,2021-09,2021-09-30,2020-10-06,ACTUAL,2020-10-06,2020-10-06,ACTUAL,2020-10-06,,INTERVENTIONAL,,,Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer,Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer,TERMINATED,,PHASE2,7.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,Low accrual due to COVID-19 pandemic.,f,,,,,t,f,,,,,,,,,NO,,2024-10-14 22:43:57.941745,2024-10-14 22:43:57.941745,OTHER,,,,,,,2020,0.0
NCT02657434,,2016-01-14,2020-07-07,,2023-11-20,2016-01-14,2016-01-15,ESTIMATED,2020-09-17,2020-10-09,ACTUAL,,,,2023-11-20,2023-11-21,ACTUAL,2016-04-30,ACTUAL,2016-04-30,2023-11,2023-11-30,2022-12-13,ACTUAL,2022-12-13,2019-07-18,ACTUAL,2019-07-18,,INTERVENTIONAL,,,A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132),"A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-Pd-L1 Antibody) in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Patients Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer",COMPLETED,,PHASE3,578.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,INDUSTRY,,,,,,,2022,1.0
NCT04802031,,2021-03-13,,,2022-07-03,2021-03-13,2021-03-17,ACTUAL,,,,,,,2022-07-03,2022-07-07,ACTUAL,2021-05-28,ACTUAL,2021-05-28,2022-07,2022-07-31,2022-12-31,ESTIMATED,2022-12-31,2022-11-30,ESTIMATED,2022-11-30,,INTERVENTIONAL,,,Rapid-infusion Isatuximab in Relapsed/Refractory Multiple Myeloma,Safety of Rapid-Infusion Isatuximab in Patients With Relapsed/Refractory Multiple Myeloma,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, San Francisco",,1.0,,Low accrual,,,,,t,t,f,,,f,,,,,,NO,,2024-10-14 22:43:57.941745,2024-10-14 22:43:57.941745,OTHER,,,,,,,2022,0.0
NCT04181723,,2019-11-26,2023-04-02,2022-10-27,2024-04-05,2019-11-26,2019-11-29,ACTUAL,2024-04-05,2024-04-08,ACTUAL,,2024-04-08,ACTUAL,2024-04-05,2024-04-08,ACTUAL,2019-11-06,ACTUAL,2019-11-06,2024-04,2024-04-30,2021-10-28,ACTUAL,2021-10-28,2021-10-28,ACTUAL,2021-10-28,,INTERVENTIONAL,,,Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™),"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome",COMPLETED,,PHASE3,187.0,ACTUAL,ACADIA Pharmaceuticals Inc.,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 19:45:25.709733,2024-10-16 19:45:25.709733,INDUSTRY,,,,,,,2021,1.0
NCT05110781,,2021-10-13,2023-05-31,,2023-08-16,2021-10-26,2021-11-08,ACTUAL,2023-08-16,2023-09-05,ACTUAL,,,,2023-08-16,2023-09-05,ACTUAL,2021-12-07,ACTUAL,2021-12-07,2023-08,2023-08-31,2023-04-18,ACTUAL,2023-04-18,2022-05-02,ACTUAL,2022-05-02,,INTERVENTIONAL,,,Atezolizumab Before Surgery for the Treatment of Regionally Metastatic Head and Neck Squamous Cell Cancer With an Unknown or Historic Primary Site,Neo-Adjuvant Atezolizumab Prior to Definitive Surgical Resection of Regionally Metastatic Head &Amp; Neck Cutaneous Squamous Cell Carcinoma With an Unknown or Historic Primary Site: A Window Trial,TERMINATED,,PHASE2,1.0,ACTUAL,"University of California, Davis",One participant was enrolled in study prior to termination. Enrollment in the clinical trial did not reach the target number of participants needed to achieve target power and was insufficient to produce statistically reliable results.,1.0,,Slow accrual,f,,,,t,t,f,,,f,,,,,,,,2024-10-14 22:43:57.941745,2024-10-14 22:43:57.941745,OTHER,,,,,,,2023,0.0
NCT04682249,,2020-12-20,,,2021-02-01,2020-12-20,2020-12-23,ACTUAL,,,,,,,2021-02-01,2021-02-04,ACTUAL,2020-12-01,ACTUAL,2020-12-01,2021-02,2021-02-28,2021-02-01,ACTUAL,2021-02-01,2021-02-01,ACTUAL,2021-02-01,,INTERVENTIONAL,,,"Systemic Chemotherapy, Apatinib Plus Sintilimab for Metastasis ICC","Systemic Chemotherapy Based on Oxaliplatin and 5-fluorouracil, Apatinib Plus Sintilimab for Metastasis ICC: a Single Arm Prospective Study",WITHDRAWN,,PHASE2,0.0,ACTUAL,Sun Yat-sen University,,1.0,,no patients enrolled,f,,,,t,f,f,,,,,,,,,,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,OTHER,,,,,,,2021,0.0
NCT03136653,,2017-04-18,,,2021-08-19,2017-04-27,2017-05-02,ACTUAL,,,,,,,2021-08-19,2021-08-25,ACTUAL,2017-05-23,ACTUAL,2017-05-23,2021-08,2021-08-31,2021-01-13,ACTUAL,2021-01-13,2020-10-12,ACTUAL,2020-10-12,,INTERVENTIONAL,,,A Phase 2 Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Multiple Myeloma,"A Phase 2 Open-label, Single-arm, Multicenter Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma",COMPLETED,,PHASE1/PHASE2,33.0,ACTUAL,Molecular Partners AG,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 22:43:57.941745,2024-10-14 22:43:57.941745,INDUSTRY,,,,,,,2021,1.0
NCT02897050,,2016-09-07,,,2022-04-19,2016-09-09,2016-09-12,ESTIMATED,,,,,,,2022-04-19,2022-04-20,ACTUAL,2016-09,ACTUAL,2016-09-30,2022-04,2022-04-30,2024-09,ESTIMATED,2024-09-30,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer,Phase II Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer,SUSPENDED,,PHASE2,170.0,ESTIMATED,Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University,,2.0,,,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,OTHER,,,,,,,2024,0.0
NCT03656744,,2018-08-30,2021-05-12,,2021-11-30,2018-08-30,2018-09-04,ACTUAL,2021-11-30,2021-12-29,ACTUAL,,,,2021-11-30,2021-12-29,ACTUAL,2018-11-26,ACTUAL,2018-11-26,2021-11,2021-11-30,2020-03-09,ACTUAL,2020-03-09,2020-02-07,ACTUAL,2020-02-07,,INTERVENTIONAL,,"One-hundred one subjects were randomized into the study, however, subject did not receive investigational study drug and was not included in the efficacy or safety analyses data sets.",A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM),A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adults With NASH and T2DM,COMPLETED,,PHASE2,101.0,ACTUAL,HighTide Biopharma Pty Ltd,"The study was conducted exclusively in the United States and data may not be applicable to other populations. The study enrolled subjects with presumed NASH and diabetes. Further studies to determine the effect of HTD1801 in non-diabetics may be needed. Future studies will focus on patients with biopsy confirmed NASH and use liver histology (i.e., liver biopsies) as a histological endpoint.",3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:45:25.709733,2024-10-16 19:45:25.709733,INDUSTRY,,,,,,,2020,1.0
NCT04855240,,2021-04-19,2023-02-15,,2023-04-08,2021-04-21,2021-04-22,ACTUAL,2023-04-08,2023-05-03,ACTUAL,,,,2023-04-08,2023-05-03,ACTUAL,2021-03-29,ACTUAL,2021-03-29,2023-02,2023-02-28,2022-03-14,ACTUAL,2022-03-14,2022-02-11,ACTUAL,2022-02-11,,INTERVENTIONAL,,,Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ACP-044 for Acute Postoperative Pain Following Orthopedic Surgery (Bunionectomy)",COMPLETED,,PHASE2,239.0,ACTUAL,ACADIA Pharmaceuticals Inc.,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:43:57.941745,2024-10-14 22:43:57.941745,INDUSTRY,,,,,,,2022,1.0
NCT04878315,,2021-05-04,,,2023-01-25,2021-05-04,2021-05-07,ACTUAL,,,,,,,2023-01-25,2023-01-27,ACTUAL,2022-02-13,ESTIMATED,2022-02-13,2023-01,2023-01-31,2022-03-25,ESTIMATED,2022-03-25,2022-03-25,ESTIMATED,2022-03-25,,INTERVENTIONAL,,,Bioequivalence Study Between Capoten Versus Captopril Reference Product in Healthy Adult Participants Under Fasting Conditions,"An Open-label, Randomized Three Period, Three Sequence, Partially Replicated Crossover Bioequivalence Study of Two Oral Formulations of Captopril 50 mg Film Coated Tablets in Healthy Adult Participants Under Fasting Conditions",WITHDRAWN,,PHASE1,0.0,ACTUAL,GlaxoSmithKline,,3.0,,Internal sponsor decision to terminate project prematurely based on a waiver granted by Egypt EDA (Egyptian drug authority). No subjects were enrolled.,f,,,,f,f,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,INDUSTRY,,,,,,,2022,0.0
NCT02985177,,2016-10-25,,,2022-11-22,2016-12-04,2016-12-07,ESTIMATED,,,,,,,2022-11-22,2022-11-23,ACTUAL,2020-01,ESTIMATED,2020-01-31,2022-10,2022-10-31,2021-09,ESTIMATED,2021-09-30,2021-07,ESTIMATED,2021-07-31,,INTERVENTIONAL,CAST,,A RCT of a Combination of Analgesics for Pain Management in Children With a Suspected Fracture,A Randomized Controlled Trial of a Combination of Analgesics for Pain Management in Children With a Suspected Fracture at Triage (CAST Trial),WITHDRAWN,,PHASE4,0.0,ACTUAL,St. Justine's Hospital,,2.0,,We couldn't obtain funds for this study,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-14 22:43:57.941745,2024-10-14 22:43:57.941745,OTHER,,,,,,,2021,0.0
NCT05281562,,2022-03-07,,,2023-03-20,2022-03-07,2022-03-16,ACTUAL,,,,,,,2023-03-20,2023-03-22,ACTUAL,2022-07-01,ACTUAL,2022-07-01,2023-03,2023-03-31,2023-03-20,ACTUAL,2023-03-20,2023-03-20,ACTUAL,2023-03-20,,INTERVENTIONAL,,,Immunonutrition for Diabetic Foot Ulcers,Effects of Supplemental Immunonutrition on Healing of Chronic Non-Healing Lower Extremity Ulcers in Diabetic Patients: A Pilot Study,TERMINATED,,PHASE2/PHASE3,1.0,ACTUAL,Prisma Health-Midlands,,2.0,,There are not enough patients at our institution meeting eligibility criteria to complete the study as intended.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,OTHER,,,,,,,2023,0.0
NCT05110599,,2021-10-05,,,2023-12-06,2021-11-04,2021-11-08,ACTUAL,,,,,,,2023-12-06,2023-12-13,ACTUAL,2022-07-12,ACTUAL,2022-07-12,2023-12,2023-12-31,2023-10-01,ACTUAL,2023-10-01,2023-08-25,ACTUAL,2023-08-25,,INTERVENTIONAL,,,Bryophyllum Pinnatum Treatment of Anxiety Related to Signs of Preterm Birth,"Bryophyllum Pinnatum Treatment of Anxiety Related to Signs of Preterm Birth: a Randomised, Double-blind, Placebo-controlled Study as Investigator-Initiated Trial",TERMINATED,,PHASE2,60.0,ACTUAL,University of Zurich,,2.0,,Slow recruitment and expired study medication.,f,,,,t,f,f,,,,,,,,,,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,OTHER,,,,,,,2023,0.0
NCT05655130,,2022-12-06,,,2024-01-19,2022-12-14,2022-12-19,ACTUAL,,,,,,,2024-01-19,2024-01-23,ACTUAL,2018-11-06,ACTUAL,2018-11-06,2024-01,2024-01-31,2023-05-02,ACTUAL,2023-05-02,2023-05-02,ACTUAL,2023-05-02,,INTERVENTIONAL,,,Distal Radius Steroid,Effects of Peri-Operative Glucosteroid Administration on Outcomes Following Distal Radius Fracture,TERMINATED,,PHASE1,30.0,ACTUAL,Indiana Hand to Shoulder Center,,2.0,,Low participation rate,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 19:45:25.709733,2024-10-16 19:45:25.709733,OTHER,,,,,,,2023,0.0
NCT02465593,,2015-06-01,,,2021-12-17,2015-06-04,2015-06-08,ESTIMATED,,,,,,,2021-12-17,2022-01-11,ACTUAL,2015-06,,2015-06-30,2021-12,2021-12-31,2021-07-28,ACTUAL,2021-07-28,2021-07-28,ACTUAL,2021-07-28,,INTERVENTIONAL,,,A Study of PEP503(Radio-enhancer) With Radiotherapy and Chemotherapy for Patients With Rectal Cancer,"A Phase Ib/II Study of PEP503 (Radioenhancer) With Radiotherapy, in Combination With Concurrent Chemotherapy for Patients With Locally Advanced or Unresectable Rectal Cancer",TERMINATED,,PHASE1/PHASE2,32.0,ACTUAL,PharmaEngine,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,INDUSTRY,,,,,,,2021,0.0
NCT02532660,,2015-08-23,,,2022-06-13,2015-08-25,2015-08-26,ESTIMATED,,,,,,,2022-06-13,2022-06-16,ACTUAL,2018-07-02,ACTUAL,2018-07-02,2022-06,2022-06-30,2022-06-01,ACTUAL,2022-06-01,2022-06-01,ACTUAL,2022-06-01,,INTERVENTIONAL,LABCATTCJUSS,,Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode,Fase III Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode,TERMINATED,,PHASE3,111.0,ACTUAL,Laboratório Catarinense SA,,3.0,,Recruitment difficulties due to monocentric study,f,,,,f,f,f,,,,,,,,,,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,INDUSTRY,,,,,,,2022,0.0
NCT04447404,,2020-06-23,2022-06-10,,2022-07-12,2020-06-23,2020-06-25,ACTUAL,2022-07-12,2022-08-05,ACTUAL,,,,2022-07-12,2022-08-05,ACTUAL,2020-09-21,ACTUAL,2020-09-21,2022-07,2022-07-31,2021-03-04,ACTUAL,2021-03-04,2021-03-04,ACTUAL,2021-03-04,,INTERVENTIONAL,,Study terminated early due to lack of enrollment.,"DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury","A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Safety and Efficacy of DUR-928 in Subjects Infected With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury",TERMINATED,,PHASE2,2.0,ACTUAL,Durect,Early study termination led to small number (n=2) of subjects and in one treatment group.,2.0,,low enrollment,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,INDUSTRY,,,,,,,2021,0.0
NCT01421069,,2011-08-18,2022-01-13,,2022-04-06,2011-08-18,2011-08-22,ESTIMATED,2022-04-06,2022-11-14,ACTUAL,,,,2022-04-06,2022-11-14,ACTUAL,2011-10-10,ACTUAL,2011-10-10,2022-04,2022-04-30,2021-02-04,ACTUAL,2021-02-04,2021-02-04,ACTUAL,2021-02-04,,INTERVENTIONAL,CLIPPER2,"Full analysis set (FAS) included all enrolled participants from parent study B1801014 (NCT00962741) who received at least 1 dose of investigational product in parent study, regardless of whether they received any investigational product during the extension study.",Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis,"AN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014)",COMPLETED,,PHASE3,109.0,ACTUAL,Pfizer,,1.0,,,f,,,,t,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,INDUSTRY,,,,,,,2021,1.0
NCT04248712,,2020-01-28,2022-10-20,,2022-11-28,2020-01-29,2020-01-30,ACTUAL,2022-11-28,2022-12-20,ACTUAL,,,,2022-11-28,2022-12-20,ACTUAL,2020-07-10,ACTUAL,2020-07-10,2022-11,2022-11-30,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,ATEE,Terminated study due to low enrollment. No subjects enrolled in the Placebo group,Antihistamines in Eosinophilic Esophagitis,"A Phase II, Randomized, Placebo-controlled Study Evaluating the Efficacy of Antihistamines in the Treatment of Eosinophilic Esophagitis (the ATEE Study)",TERMINATED,,PHASE2,1.0,ACTUAL,Mayo Clinic,Terminated study due to low enrollment. No subjects enrolled in the Placebo group,2.0,,low enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,OTHER,,,,,,,2021,0.0
NCT02099825,,2014-03-19,,,2023-04-24,2014-03-26,2014-03-31,ESTIMATED,,,,,,,2023-04-24,2023-04-26,ACTUAL,2014-01-13,ACTUAL,2014-01-13,2023-04,2023-04-30,2022-10,ACTUAL,2022-10-31,2022-10,ACTUAL,2022-10-31,,INTERVENTIONAL,MERiT,,Medication Enhanced Rapid Therapy,Medication Enhanced Rapid Therapy,TERMINATED,,PHASE1,15.0,ACTUAL,Washington University School of Medicine,,2.0,,COVID and staffing issues,f,,,,f,,,,,,,,,,,,,2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,OTHER,,,,,,,2022,0.0
NCT04794803,,2021-03-08,2022-02-21,,2024-01-05,2021-03-11,2021-03-12,ACTUAL,2022-03-15,2022-03-17,ACTUAL,,,,2024-01-05,2024-01-08,ACTUAL,2020-05-05,ACTUAL,2020-05-05,2022-05,2022-05-31,2021-02-02,ACTUAL,2021-02-02,2020-11-27,ACTUAL,2020-11-27,,INTERVENTIONAL,,"The Full Analysis Set (FAS), which consisted of all randomized subjects who received at least one dose of the IMP. The FAS population was analyzed according to intention to treat (ITT) principle, i.e. by treatment allocation regardless the occurrence of intercurrent events.",Reparixin in COVID-19 Pneumonia - Efficacy and Safety,Study on the Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With COVID-19 Pneumonia,TERMINATED,,PHASE2/PHASE3,56.0,ACTUAL,Dompé Farmaceutici S.p.A,,2.0,,The sponsor has decided to start with a separate protocol for phase 3 and therefore this study was terminated with only phase 2.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,INDUSTRY,,,,,,,2021,0.0
NCT03668392,,2018-09-11,,,2022-03-01,2018-09-11,2018-09-12,ACTUAL,,,,,,,2022-03-01,2022-03-16,ACTUAL,2020-06-25,ACTUAL,2020-06-25,2022-03,2022-03-31,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,ALL2518,,Asparaginase Activity Monitoring (AAM) in Adult Patients With Acute Lymphoblastic Leukemia (ALL),Asparaginase Activity Monitoring (AAM) in Adult Patients With Acute Lymphoblastic Leukemia (ALL),TERMINATED,,PHASE2,7.0,ACTUAL,Gruppo Italiano Malattie EMatologiche dell'Adulto,,1.0,,low enrollment rate,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 19:45:25.709733,2024-10-16 19:45:25.709733,OTHER,,,,,,,2021,0.0
NCT04012333,,2019-07-03,,,2022-10-25,2019-07-08,2019-07-09,ACTUAL,,,,,,,2022-10-25,2022-10-27,ACTUAL,2020-06,ESTIMATED,2020-06-30,2022-10,2022-10-31,2022-03,ESTIMATED,2022-03-31,2022-03,ESTIMATED,2022-03-31,,INTERVENTIONAL,EFFORTcombo,,The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial,The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,RWTH Aachen University,,2.0,,PI left site,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,OTHER,,,,,,,2022,0.0
NCT04562155,,2020-09-18,2022-06-18,,2022-07-24,2020-09-18,2020-09-24,ACTUAL,2022-07-24,2022-08-18,ACTUAL,,,,2022-07-24,2022-08-18,ACTUAL,2020-10-02,ACTUAL,2020-10-02,2022-07,2022-07-31,2021-07-23,ACTUAL,2021-07-23,2021-06-22,ACTUAL,2021-06-22,,INTERVENTIONAL,PAGANINI,,Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough,"Randomized, Double-blind, Parallel Group, Phase 2b Dose-finding, Efficacy and Safety Study of 12-week Twice Daily Oral Administration of BAY 1817080 Compared to Placebo in the Treatment of Refractory and/or Unexplained Chronic Cough (RUCC)",COMPLETED,,PHASE2,310.0,ACTUAL,Bayer,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-16 19:45:25.709733,2024-10-16 19:45:25.709733,INDUSTRY,,,,,,,2021,1.0
NCT04901806,,2021-05-20,,,2024-03-26,2021-05-20,2021-05-26,ACTUAL,,,,,,,2024-03-26,2024-03-28,ACTUAL,2021-07-20,ACTUAL,2021-07-20,2024-03,2024-03-31,2023-07-26,ACTUAL,2023-07-26,2023-07-26,ACTUAL,2023-07-26,,INTERVENTIONAL,,,Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors,A Phase 1/2 Study of PBI-200 in Subjects With NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors,TERMINATED,,PHASE1,29.0,ACTUAL,Pyramid Biosciences,,2.0,,Sponsor terminated development of PBI-200,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,INDUSTRY,,,,,,,2023,0.0
NCT05244473,,2022-02-07,,,2023-02-10,2022-02-16,2022-02-17,ACTUAL,,,,,,,2023-02-10,2023-02-14,ACTUAL,2022-12-31,ESTIMATED,2022-12-31,2023-02,2023-02-28,2024-05-31,ESTIMATED,2024-05-31,2024-05-31,ESTIMATED,2024-05-31,,INTERVENTIONAL,,,A Safety Study of Brentuximab Vedotin in Participants With HIV,"A Phase 1, Single-blind, Dose-escalation Study to Assess the Safety and Tolerability of Brentuximab Vedotin (ADCETRIS®) in Subjects With Human Immunodeficiency Virus (HIV)",WITHDRAWN,,PHASE1,0.0,ACTUAL,Seagen Inc.,,2.0,,Study withdrawn due to low patient accrual.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,INDUSTRY,,,,,,,2024,0.0
NCT03343678,,2017-11-13,,,2018-01-08,2017-11-13,2017-11-17,ACTUAL,,,,,,,2018-01-08,2018-01-09,ACTUAL,2018-01-17,ESTIMATED,2018-01-17,2018-01,2018-01-31,2020-11-25,ESTIMATED,2020-11-25,2018-05-25,ESTIMATED,2018-05-25,,INTERVENTIONAL,,,This Study in Patients With Chronic Lymphocytic Leukaemia is Done to Determine a Safe and Effective Dose of BI 836826 in Combination With Venetoclax,"An Open-label, Multi-centre, Phase Ib Trial to Determine the Dose of Intravenous BI 836826 in Combination With Oral Venetoclax in Chronic Lymphocytic Leukaemia Patients Who Are Eligible for Treatment With Venetoclax",WITHDRAWN,,PHASE1,0.0,ACTUAL,Boehringer Ingelheim,,1.0,,Company strategic decision,f,,,,f,f,f,,,,,,,,,,,2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,INDUSTRY,,,,,,,2020,0.0
NCT03778073,,2018-12-11,,,2022-08-19,2018-12-14,2018-12-19,ACTUAL,,,,,,,2022-08-19,2022-08-22,ACTUAL,2019-04-17,ACTUAL,2019-04-17,2022-08,2022-08-31,2022-08-01,ACTUAL,2022-08-01,2022-05-03,ACTUAL,2022-05-03,,INTERVENTIONAL,,,Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma,A Phase 1 Study of Cosibelimab (TG-1501) in Subjects With Relapsed or Refractory Lymphoma,TERMINATED,,PHASE1,18.0,ACTUAL,"TG Therapeutics, Inc.",,3.0,,Strategic/Business Decision,,,,,f,t,f,,,,,,,,,,,2024-10-16 19:45:25.709733,2024-10-16 19:45:25.709733,INDUSTRY,,,,,,,2022,0.0
NCT00738777,,2008-08-19,,,2021-01-20,2008-08-19,2008-08-20,ESTIMATED,,,,,,,2021-01-20,2021-01-22,ACTUAL,2008-07,ACTUAL,2008-07-31,2021-01,2021-01-31,2024-06,ESTIMATED,2024-06-30,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer,"A Randomized, Prospective Trial of 2-6 Weeks Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer: Anastrozole +/- Fulvestrant or Tamoxifen Exposure - Response in Molecular Profile (AFTER-study).",SUSPENDED,,PHASE2,250.0,ESTIMATED,The Netherlands Cancer Institute,,4.0,,in preparation for an amendment,f,,,,f,,,,,,,,,,,,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,OTHER,,,,,,,2024,0.0
NCT03083665,,2017-02-28,2022-12-15,,2024-05-14,2017-03-14,2017-03-20,ACTUAL,2023-11-08,2023-11-09,ACTUAL,,,,2024-05-14,2024-06-11,ACTUAL,2017-08-22,ACTUAL,2017-08-22,2024-05,2024-05-31,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,Baseline Characteristics refer to the Randomized Set (RS) which consisted of all study participants who were randomized to investigational medicinal product (IMP).,A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy,"A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam in Subjects (>=16 to 80 Years of Age) With Partial Seizures With or Without Secondary Generalization",COMPLETED,,PHASE3,449.0,ACTUAL,UCB Pharma,,3.0,,,f,,,,f,f,f,,,,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",https://vivli.org/,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,INDUSTRY,,,,,,,2022,1.0
NCT01953926,,2013-09-26,2023-12-21,,2024-02-12,2013-09-26,2013-10-01,ESTIMATED,2024-02-12,2024-03-12,ACTUAL,,,,2024-02-12,2024-03-12,ACTUAL,2013-09-30,ACTUAL,2013-09-30,2024-02,2024-02-29,2023-01-02,ACTUAL,2023-01-02,2023-01-02,ACTUAL,2023-01-02,,INTERVENTIONAL,SUMMIT,,Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations,"An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations",TERMINATED,,PHASE2,582.0,ACTUAL,"Puma Biotechnology, Inc.",,6.0,,The study was terminated to align with the sponsor's current development plans for neratinib. The decision was not based on any new efficacy or safety data for neratinib.,f,,,,t,t,f,,,,,,"Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.","Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.~Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.",https://pumabiotechnology.com/data_sharing_policy.html,YES,"Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.~In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.~Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.~Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.",2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,INDUSTRY,,,,,,,2023,0.0
NCT05827068,,2023-04-12,,,2023-11-22,2023-04-12,2023-04-24,ACTUAL,,,,,,,2023-11-22,2023-11-24,ACTUAL,2023-03-27,ACTUAL,2023-03-27,2023-11,2023-11-30,2023-11-20,ACTUAL,2023-11-20,2023-11-20,ACTUAL,2023-11-20,,INTERVENTIONAL,,,"A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults","A Phase 1/2, Randomized, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults 50 to 75 Years of Age",COMPLETED,,PHASE1/PHASE2,700.0,ACTUAL,"ModernaTX, Inc.",,7.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,INDUSTRY,,,,,,,2023,1.0
NCT04277546,,2020-02-18,,,2023-11-08,2020-02-18,2020-02-20,ACTUAL,,,,,,,2023-11-08,2023-11-09,ACTUAL,2020-03-03,ACTUAL,2020-03-03,2023-10,2023-10-31,2023-10-10,ACTUAL,2023-10-10,2023-10-10,ACTUAL,2023-10-10,,INTERVENTIONAL,Expedition,,Open-label Extension Study of Brazikumab in Ulcerative Colitis,"A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE)",TERMINATED,,PHASE2,57.0,ACTUAL,AstraZeneca,,2.0,,Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.,f,,,,,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,INDUSTRY,,,,,,,2023,0.0
NCT04345692,,2020-04-09,,,2020-11-13,2020-04-13,2020-04-14,ACTUAL,,,,,,,2020-11-13,2020-11-17,ACTUAL,2020-03-26,ACTUAL,2020-03-26,2020-11,2020-11-30,2020-08-31,ACTUAL,2020-08-31,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,OAHU-COVID19,,A Randomized Controlled Clinical Trial: Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients,"A Randomized, Controlled Clinical Trial of the Safety and Efficacy of Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients",TERMINATED,,PHASE3,17.0,ACTUAL,Queen's Medical Center,,2.0,,RECOVERY Trial results - no efficacy,f,,,,,t,f,,,t,,,,,,NO,,2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,OTHER,,,,,,,2020,0.0
NCT02452385,,2015-03-10,,,2020-01-08,2015-05-20,2015-05-22,ESTIMATED,,,,,,,2020-01-08,2020-01-13,ACTUAL,2015-03,,2015-03-31,2020-01,2020-01-31,2020-06,ESTIMATED,2020-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,Phase 1 Study of CM082 in Patients With wAMD,"Phase 1 Study of CM082 in Patients With wAMD: Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy",SUSPENDED,,PHASE1,56.0,ESTIMATED,AnewPharma,,1.0,,Sponsor requirements,f,,,,f,,,,,,,,,,,,,2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,INDUSTRY,,,,,,,2020,0.0
NCT02720523,,2016-03-22,2019-09-13,,2023-06-05,2016-03-22,2016-03-28,ESTIMATED,2019-10-17,2019-10-21,ACTUAL,,,,2023-06-05,2023-06-07,ACTUAL,2016-03-22,ACTUAL,2016-03-22,2023-06,2023-06-30,2022-06-07,ACTUAL,2022-06-07,2017-08-03,ACTUAL,2017-08-03,,INTERVENTIONAL,SELECTSUNRISE,The Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.,A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis (RA) Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs,"A Phase 2b/3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Japanese Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs",COMPLETED,,PHASE2/PHASE3,197.0,ACTUAL,AbbVie,,6.0,,,f,,,,t,f,f,,,,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,INDUSTRY,,,,,,,2022,1.0
NCT04738175,,2021-02-02,,,2022-02-09,2021-02-02,2021-02-04,ACTUAL,,,,,,,2022-02-09,2022-02-25,ACTUAL,2021-04,ESTIMATED,2021-04-30,2022-02,2022-02-28,2021-11,ESTIMATED,2021-11-30,2021-11,ESTIMATED,2021-11-30,,INTERVENTIONAL,,,Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19,"A Randomized, Controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,2.0,,A different study will be conducted.,f,,,,t,t,f,,,,,,,,,,,2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,INDUSTRY,,,,,,,2021,0.0
NCT04311112,,2020-03-12,,,2023-02-22,2020-03-16,2020-03-17,ACTUAL,,,,,,,2023-02-22,2023-02-24,ACTUAL,2020-12,ESTIMATED,2020-12-31,2020-10,2020-10-31,2023-09,ESTIMATED,2023-09-30,2023-02,ESTIMATED,2023-02-28,,INTERVENTIONAL,,,Safety and Efficacy of Zuretinol Acetate in Subjects With Inherited Retinal Disease,Safety and Efficacy of Zuretinol Acetate Oral Solution in Subjects With Inherited Retinal Disease Caused by Mutations in Retinal Pigment Epithelium Protein 65 or Lecithin:Retinol Acyltransferase,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Retinagenix Holdings,,3.0,,The asset was transferred to another company,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,INDUSTRY,,,,,,,2023,0.0
NCT05895123,,2022-10-11,,,2024-07-31,2023-06-06,2023-06-08,ACTUAL,,,,,,,2024-07-31,2024-08-01,ACTUAL,2021-11-01,ACTUAL,2021-11-01,2024-07,2024-07-31,2023-04-01,ACTUAL,2023-04-01,2023-03-01,ACTUAL,2023-03-01,,INTERVENTIONAL,,,Comparison Between the Effects of High Doses Statin on Ventricular Remodeling in STEMI Patients,Comparative Study Between the Effects of High Doses Rosuvastatin and Atorvastatin on Ventricular Remodeling in Patients With ST-Segment Elevation Myocardial Infarction,COMPLETED,,PHASE2,80.0,ACTUAL,Damanhour University,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,OTHER,,,,,,,2023,1.0
NCT04869397,,2021-04-29,,,2023-06-16,2021-04-29,2021-05-03,ACTUAL,,,,,,,2023-06-16,2023-06-22,ACTUAL,2021-06-14,ACTUAL,2021-06-14,2023-06,2023-06-30,2023-05-26,ACTUAL,2023-05-26,2023-05-26,ACTUAL,2023-05-26,,INTERVENTIONAL,ProTrans19+,,Treatment of Respiratory Complications Associated With COVID-19 Using Umbilical Cord Mesenchymal Stromal Cells,Treatment of Respiratory Complications Associated With COVID-19 Infection Using Wharton's Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®): a Randomized Phase II Controlled Clinical Trial,TERMINATED,,PHASE2,19.0,ACTUAL,McGill University Health Centre/Research Institute of the McGill University Health Centre,,2.0,,DSMB recommended to end the study prematurely as recruitment goals were not being met and benefit was not influencial enough.,f,,,,,f,f,,,,,,,,,,,2024-10-15 23:47:20.60683,2024-10-15 23:47:20.60683,OTHER,,,,,,,2023,0.0
NCT02005471,,2013-12-04,2018-05-03,,2023-09-22,2013-12-04,2013-12-09,ESTIMATED,2018-09-28,2018-10-01,ACTUAL,,,,2023-09-22,2023-10-17,ACTUAL,2014-03-17,ACTUAL,2014-03-17,2023-09,2023-09-30,2022-08-03,ACTUAL,2022-08-03,2017-05-08,ACTUAL,2017-05-08,,INTERVENTIONAL,MURANO,"Intent-to-treat (ITT) population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.",A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL),"A Multicenter, Phase III, Open-Label, Randomized Study in Relapsed/Refractory Patients With Chronic Lymphocytic Leukemia to Evaluate the Benefit of Venetoclax (GDC-0199/ABT-199) Plus Rituximab Compared With Bendamustine Plus Rituximab",COMPLETED,,PHASE3,389.0,ACTUAL,Hoffmann-La Roche,,4.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,INDUSTRY,,,,,,,2022,1.0
NCT04063150,,2019-08-19,,,2022-05-11,2019-08-19,2019-08-21,ACTUAL,,,,,,,2022-05-11,2022-05-18,ACTUAL,2019-10-06,ACTUAL,2019-10-06,2022-05,2022-05-31,2020-03-25,ACTUAL,2020-03-25,2020-03-25,ACTUAL,2020-03-25,,INTERVENTIONAL,IM and ID IPV,,Immunogenicity of Intramuscular and Intradermal IPV,Immunogenicity of Intramuscular and Intradermal Inactivated Poliovirus Vaccine in Routine Immunization,TERMINATED,,PHASE4,958.0,ACTUAL,Centers for Disease Control and Prevention,,7.0,,COVID-19 pandemic,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,FED,,,,,,,2020,0.0
NCT04089852,,2019-09-11,,,2022-09-14,2019-09-12,2019-09-13,ACTUAL,,,,,,,2022-09-14,2022-09-16,ACTUAL,2021-06-01,ESTIMATED,2021-06-01,2022-09,2022-09-30,2021-11-01,ESTIMATED,2021-11-01,2021-11-01,ESTIMATED,2021-11-01,,INTERVENTIONAL,,,Nitrous Oxide for Pain Management During IUD Insertion in Nulliparous Adolescent Women,Nitrous Oxide for Pain Management During Intrauterine Device Insertion in Nulliparous Adolescent Women,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Boston Children's Hospital,,2.0,,Not able to perform intervention in current physical clinic location,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,OTHER,,,,,,,2021,0.0
NCT02063685,,2013-11-21,,,2022-06-16,2014-02-13,2014-02-14,ESTIMATED,,,,,,,2022-06-16,2022-06-21,ACTUAL,2012-07,,2012-07-31,2022-06,2022-06-30,2021-12,ACTUAL,2021-12-31,2021-12,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Study to Evaluate the Efficacy of Response-adapted Strategy in Follicular Lymphoma,"A Multicenter, Phase III, Randomized Study to Evaluate the Efficacy of Response-adapted Strategy to Define Maintenance After Standard Chemoimmunotherapy in Patients With Advanced-stage Follicular Lymphoma.",COMPLETED,,PHASE3,807.0,ACTUAL,Fondazione Italiana Linfomi - ETS,,4.0,,,f,,,,f,,,,,,,,,,,,,2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,OTHER,,,,,,,2021,0.0
NCT04118075,,2019-10-04,,,2021-05-19,2019-10-07,2019-10-08,ACTUAL,,,,,,,2021-05-19,2021-05-21,ACTUAL,2019-01-01,ACTUAL,2019-01-01,2021-05,2021-05-31,2021-05-01,ACTUAL,2021-05-01,2021-05-01,ACTUAL,2021-05-01,,INTERVENTIONAL,,,PT-CY With or Without Low-dose ATG for Lymphoid Malignancies Undergoing Allo-HSCT,Post Transplantation Cyclophosphamide With or Without Low-dose ATG for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation,COMPLETED,,PHASE2,23.0,ACTUAL,Shanghai Jiao Tong University School of Medicine,,1.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,OTHER,,,,,,,2021,1.0
NCT05173831,,2021-12-13,,,2024-01-22,2021-12-13,2021-12-30,ACTUAL,,,,,,,2024-01-22,2024-01-24,ACTUAL,2023-09,ESTIMATED,2023-09-30,2024-01,2024-01-31,2024-12,ESTIMATED,2024-12-31,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,MPG1,,Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans,An Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder in Veterans,WITHDRAWN,,PHASE2,0.0,ACTUAL,Lykos Therapeutics,,1.0,,Transfer of Sponsorship,f,,,,f,t,f,,,,,,,,,,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,INDUSTRY,,,,,,,2024,0.0
NCT04458948,,2020-06-09,2023-05-16,,2023-08-23,2020-06-30,2020-07-07,ACTUAL,2023-08-23,2023-09-13,ACTUAL,,,,2023-08-23,2023-09-13,ACTUAL,2020-03-24,ACTUAL,2020-03-24,2023-08,2023-08-31,2020-08-28,ACTUAL,2020-08-28,2020-08-28,ACTUAL,2020-08-28,,INTERVENTIONAL,,"Our baseline population is from the state of New Mexico, Navajo nation and other surrounding Pueblo nations. We enrolled 28 patients, about equal males and females, ages from 32 to 85.",Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients,Open Label Non-comparative Trial of the Combination of Hydroxychloroquine and Azithromycin in the Treatment of Hospitalized Patients With Moderate or Severe COVID-19 Infection,TERMINATED,,PHASE2,28.0,ACTUAL,University of New Mexico,,1.0,,The World Health Organization (WHO) paused Hydrochloroquinone from its Solidarity Trial in order to conduct a safety data review by the Data Safety Monitoring Board of the WHO to evaluate HCQ in its clinical trials.,f,,,,,t,f,,,f,,,,,,UNDECIDED,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,OTHER,,,,,,,2020,0.0
NCT03521635,,2018-04-11,2020-12-22,,2021-02-08,2018-04-30,2018-05-11,ACTUAL,2021-02-08,2021-02-16,ACTUAL,,,,2021-02-08,2021-02-16,ACTUAL,2018-07-03,ACTUAL,2018-07-03,2021-02,2021-02-28,2020-01-07,ACTUAL,2020-01-07,2020-01-07,ACTUAL,2020-01-07,,INTERVENTIONAL,,Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.,The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-Dopa,"A Two- Stage Multicenter, Open-label, Randomized, Active Controlled Parallel Group Study Comparing the Efficacy and Safety of Pramipexole SR Versus Pramipexole IR Administered Orally Over an 18-week Treatment on Nocturnal Symptoms in L-Dopa+ Treated Patients With Advanced Parkinson's Disease (PD)",COMPLETED,,PHASE4,98.0,ACTUAL,Boehringer Ingelheim,"According to the study results, the decision was made to stop transitioning to Stage II. Therefore, only results of Stage I were reported.",2.0,,,,,,,f,t,f,,,,,,,,,,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,INDUSTRY,,,,,,,2020,1.0
NCT03606655,,2018-07-20,,,2020-01-09,2018-07-20,2018-07-31,ACTUAL,,,,,,,2020-01-09,2020-01-13,ACTUAL,2020-01,ESTIMATED,2020-01-31,2020-01,2020-01-31,2021-01,ESTIMATED,2021-01-31,2020-10,ESTIMATED,2020-10-31,,INTERVENTIONAL,,,Exploring the Impact of Two-week Kava on the Metabolism of Nicotine and NNK,"A Single-Arm Pre- and Post-Pilot Trial Exploring the Impact of Two-week Kava on the Metabolism of Two Tobacco Chemicals, Nicotine and NNK, in Head and Neck Cancer Survivors Who Are Active Smokers",WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Florida,,1.0,,Terms could not be met with the FDA.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:40:03.471671,2024-10-16 09:40:03.471671,OTHER,,,,,,,2021,0.0
NCT04730297,,2021-01-13,,,2021-01-25,2021-01-25,2021-01-29,ACTUAL,,,,,,,2021-01-25,2021-01-29,ACTUAL,2018-01-01,ACTUAL,2018-01-01,2021-01,2021-01-31,2020-10-14,ACTUAL,2020-10-14,2020-09-04,ACTUAL,2020-09-04,,INTERVENTIONAL,,,Comparative Analgesic Effects of Paracetamol/Codeine and Ibuprofen on Pain After Third Molar Surgery,Comparative Analgesic Effects of Preoperative Administration of Paracetamol (Acetominophen) 500 mg Plus Codeine 30 mg and Ibuprofen 400 mg on Pain After Third Molar Surgery,COMPLETED,,PHASE4,120.0,ACTUAL,University of Roma La Sapienza,,3.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 13:13:25.294172,2024-10-15 13:13:25.294172,OTHER,,,,,,,2020,1.0
NCT03782259,,2018-10-24,2023-10-26,,2023-12-11,2018-12-18,2018-12-20,ACTUAL,2023-12-11,2023-12-29,ACTUAL,,,,2023-12-11,2023-12-29,ACTUAL,2019-02-26,ACTUAL,2019-02-26,2023-12,2023-12-31,2022-11-16,ACTUAL,2022-11-16,2022-11-16,ACTUAL,2022-11-16,,INTERVENTIONAL,,,Effects of SGLT-2 Inhibition on Myocardial Fibrosis and Inflammation as Assessed by Cardiac MRI in Patients With DM2,Effects of SGLT-2 Inhibition With Dapagliflozin on Myocardial Fibrosis and Inflammation as Assessed by Cardiac MRI With T1- and T2-mapping in Patients With Type-2 Diabetes,COMPLETED,,PHASE4,62.0,ACTUAL,University of Washington,"* Relatively small trial was not powered to detect small effect sizes.~* Animal studies of SGLT2 inhibition used direct pathologic examination of inflammation and fibrosis; Cardiac MRI is known to be less sensitive.~* 12-month treatment may not have been sufficient to detect meaningful changes in inflammation, fibrosis, and strain.~* No matched, non-diabetic control group.~* Higher ECV values (\>32) are associated with worse outcomes with known myocarditis.",2.0,,,f,,,,f,t,f,,,f,,,,,,,,2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,OTHER,,,,,,,2022,1.0
NCT04538599,,2020-08-30,,,2022-01-08,2020-08-30,2020-09-04,ACTUAL,,,,,,,2022-01-08,2022-01-25,ACTUAL,2020-09-10,ACTUAL,2020-09-10,2021-09,2021-09-30,2021-11-30,ACTUAL,2021-11-30,2021-02-17,ACTUAL,2021-02-17,,INTERVENTIONAL,,,RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies,RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies,COMPLETED,,PHASE1,12.0,ACTUAL,Zhejiang University,,1.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,OTHER,,,,,,,2021,1.0
NCT04509947,,2020-08-11,,,2021-11-23,2020-08-11,2020-08-12,ACTUAL,,,,,,,2021-11-23,2021-11-24,ACTUAL,2020-08-11,ACTUAL,2020-08-11,2021-11,2021-11-30,2021-11-16,ACTUAL,2021-11-16,2021-02-22,ACTUAL,2021-02-22,,INTERVENTIONAL,,,A Study of Ad26.COV2.S in Adults (COVID-19),"A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Adults",COMPLETED,,PHASE1,250.0,ACTUAL,Janssen Pharmaceutical K.K.,,3.0,,,f,,,,f,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,INDUSTRY,,,,,,,2021,1.0
NCT05451654,,2022-07-07,,,2023-10-24,2022-07-07,2022-07-11,ACTUAL,,,,,,,2023-10-24,2023-10-26,ACTUAL,2022-02-04,ACTUAL,2022-02-04,2023-10,2023-10-31,2022-12-01,ACTUAL,2022-12-01,2022-10-04,ACTUAL,2022-10-04,,INTERVENTIONAL,,,"NanoMn®_COVID-19 A Prospective, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blind Trial to Evaluate the Clinical Efficacy of NanoManganese® on Top of Standard of Care, in Adult Patients With Moderate to Severe Coronavirus Disease 2019 (COVID-19)","A Prospective, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blind Trial to Evaluate the Clinical Efficacy of NanoManganese® on Top of Standard of Care, in Adult Patients With Moderate to Severe Coronavirus Disease 2019 (COVID-19)",TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,Medesis Pharma SA,,2.0,,the number of patients recruited was not reached because covid cases were low,f,,,,f,f,f,,,,,,,,,,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,INDUSTRY,,,,,,,2022,0.0
NCT04992208,,2021-08-02,,,2023-09-21,2021-08-04,2021-08-05,ACTUAL,,,,,,,2023-09-21,2023-09-25,ACTUAL,2021-07-24,ACTUAL,2021-07-24,2021-08,2021-08-31,2023-08-31,ACTUAL,2023-08-31,2023-03-24,ACTUAL,2023-03-24,,INTERVENTIONAL,,,Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Children and Adolescents,"Safety Observation of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Population Aged 3~17 Years : A Multicenter,Open-label Study",COMPLETED,,PHASE4,31041.0,ACTUAL,"Sinovac Biotech Co., Ltd",,1.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,,,,,,2023,1.0
NCT03835481,,2019-02-07,2022-06-20,,2022-10-27,2019-02-07,2019-02-08,ACTUAL,2022-10-27,2022-11-18,ACTUAL,,,,2022-10-27,2022-11-18,ACTUAL,2019-03-18,ACTUAL,2019-03-18,2022-10,2022-10-31,2021-07-27,ACTUAL,2021-07-27,2021-06-22,ACTUAL,2021-06-22,,INTERVENTIONAL,,Treated Set (TS): All patients who received at least one dose of treatment in the extension trial.,A Study to Test How Well Patients With Plaque Psoriasis Tolerate BI 730357 Over a Longer Period and How Effective it is,"Phase II Long-term Extension Study to Assess the Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis",TERMINATED,,PHASE2,165.0,ACTUAL,Boehringer Ingelheim,"The trial was ended prematurely by the sponsor. As a consequence, primary and secondary endpoints were limited to descriptive outcome measures. The recruitment was completed as planned.",5.0,,Due to company decision.,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-14 22:49:50.819707,2024-10-14 22:49:50.819707,INDUSTRY,,,,,,,2021,0.0
NCT04233073,,2020-01-14,2022-11-21,,2023-02-24,2020-01-15,2020-01-18,ACTUAL,2023-02-24,2023-03-22,ACTUAL,,,,2023-02-24,2023-03-22,ACTUAL,2021-06-27,ACTUAL,2021-06-27,2023-02,2023-02-28,2022-01-25,ACTUAL,2022-01-25,2021-11-23,ACTUAL,2021-11-23,,INTERVENTIONAL,Annexa-S,"Safety Set: Participants who were enrolled into the study and treated with any amount of andexanet alfa. All data were prespecified to be collected as a single Arm/Group for any participant who received at least 1 dose of the study drug, regardless of their dose level.",Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery,"Prospective, Open-Label Clinical Study of Andexanet Alfa in Patients Receiving FXa (Activated Factor X) Inhibitor Who Require Urgent Surgery",TERMINATED,,PHASE2,10.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",The study was terminated early due to the limited value as a single-arm study.,,,Limited value as a single-arm study,f,,,,t,t,f,,,,,,,,,YES,"Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.",2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,,,,,,2022,0.0
NCT04988308,,2021-07-30,2023-10-12,,2023-10-12,2021-07-30,2021-08-03,ACTUAL,2023-10-12,2023-11-13,ACTUAL,,,,2023-10-12,2023-11-13,ACTUAL,2021-10-12,ACTUAL,2021-10-12,2023-10,2023-10-31,2022-11-23,ACTUAL,2022-11-23,2022-10-14,ACTUAL,2022-10-14,,INTERVENTIONAL,LYRA,,A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa,"A Phase 2a/2b, Multicenter, Randomized, Placebo and Active Comparator-controlled, Double-Blind, Dose-ranging Study to Evaluate the Safety and Efficacy of Bermekimab (JNJ-77474462) for the Treatment of Subjects With Moderate to Severe Hidradenitis Suppurativa",TERMINATED,,PHASE2,151.0,ACTUAL,"Janssen Research & Development, LLC","As per change in planned analysis, Part 2 and some secondary efficacy analysis of Part 1 in this study was not conducted due to early termination because interim analysis 1 efficacy results met the prespecified futility criteria related to the primary endpoint. Hence, data for Part 2 and some secondary efficacy outcome measures (Parts 1 and 2) were not collected in this results summary.",7.0,,Study has been prematurely terminated as the Interim Analysis 1 efficacy results met the prespecified futility criteria related to the primary endpoint.,f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,INDUSTRY,,,,,,,2022,0.0
NCT03915405,,2019-03-19,,,2024-04-24,2019-04-11,2019-04-16,ACTUAL,,,,,,,2024-04-24,2024-04-25,ACTUAL,2019-09-26,ACTUAL,2019-09-26,2024-04,2024-04-30,2022-11-15,ACTUAL,2022-11-15,2022-11-15,ACTUAL,2022-11-15,,INTERVENTIONAL,,,KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer,"An Open-label, Phase 1 Study of KHK2455 in Combination With Avelumab in Adult Subjects With Locally Advanced or Metastatic Urothelial Carcinoma",TERMINATED,,PHASE1,16.0,ACTUAL,"Kyowa Kirin Co., Ltd.",,1.0,,Termination was based on the business decision,f,,,,,t,f,,,,,,,,,,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,,,,,,2022,0.0
NCT04625543,,2020-11-06,,,2022-04-19,2020-11-06,2020-11-12,ACTUAL,,,,,,,2022-04-19,2022-04-26,ACTUAL,2020-12,ESTIMATED,2020-12-31,2022-04,2022-04-30,2023-09,ESTIMATED,2023-09-30,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,Neoadjuvant Immunotherapy to ESCC,"Neoadjuvant Immunotherapy Combined With Neoadjuvant Chemotherapy for Locally Advanced Esophageal Cancer: an Open Label, Randomized Control, Phase II Trial",WITHDRAWN,,PHASE2,0.0,ACTUAL,Qilu Hospital of Shandong University,,2.0,,insufficient money,f,,,,,f,f,,,,,,,,,,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,OTHER,,,,,,,2023,0.0
NCT03522415,,2018-04-29,,,2022-05-04,2018-05-10,2018-05-11,ACTUAL,,,,,,,2022-05-04,2022-05-09,ACTUAL,2018-05-28,ACTUAL,2018-05-28,2022-05,2022-05-31,2020-09-11,ACTUAL,2020-09-11,2020-04-05,ACTUAL,2020-04-05,,INTERVENTIONAL,,,Study of Safety and Efficacy of HLX01+MTX in Patients With Rheumatoid Arthritis,"A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HLX01 (Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection) Combined With MTX Therapy in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate",COMPLETED,,PHASE3,275.0,ACTUAL,Shanghai Henlius Biotech,,2.0,,,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,INDUSTRY,,,,,,,2020,1.0
NCT03687476,,2018-08-06,,,2020-07-20,2018-09-25,2018-09-27,ACTUAL,,,,,,,2020-07-20,2020-07-22,ACTUAL,2020-05,ESTIMATED,2020-05-31,2020-07,2020-07-31,2022-10-30,ESTIMATED,2022-10-30,2022-10-30,ESTIMATED,2022-10-30,,INTERVENTIONAL,,,Safety and Tolerability Study of VTS-270 in Pediatric Participants With Niemann-Pick Type C (NPC) Disease,"An Open-label, Multicenter Safety and Tolerability Study of VTS-270 (2-hydroxypropyl-β-cyclodextrin) in Pediatric Subjects Aged < 4 Years With Neurologic Manifestations of Niemann-Pick Type C (NPC) Disease",WITHDRAWN,,PHASE2,0.0,ACTUAL,Mallinckrodt,,2.0,,Business decision to Cancel,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,INDUSTRY,,,,,,,2022,0.0
NCT03525600,,2018-04-20,2023-05-24,2022-06-20,2023-05-24,2018-05-03,2018-05-15,ACTUAL,2023-05-24,2023-06-18,ACTUAL,2022-06-20,2022-06-22,ACTUAL,2023-05-24,2023-06-18,ACTUAL,2018-08-31,ACTUAL,2018-08-31,2023-05,2023-05-31,2022-06-20,ACTUAL,2022-06-20,2021-06-21,ACTUAL,2021-06-21,,INTERVENTIONAL,,The Intent-to-treat (ITT) analysis set consisted of all subjects assigned to treatment.,Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration,"A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)",COMPLETED,,PHASE3,621.0,ACTUAL,"Apellis Pharmaceuticals, Inc.",,4.0,,,,,,,t,t,f,,,,,,,,,,,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,INDUSTRY,,,,,,,2022,1.0
NCT03930771,,2019-04-25,2022-05-27,,2022-07-15,2019-04-26,2019-04-29,ACTUAL,2022-07-15,2022-08-09,ACTUAL,,,,2022-07-15,2022-08-09,ACTUAL,2019-05-21,ACTUAL,2019-05-21,2022-07,2022-07-31,2021-10-01,ACTUAL,2021-10-01,2021-08-19,ACTUAL,2021-08-19,,INTERVENTIONAL,TMZ-Cap,,Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas,Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas,TERMINATED,,PHASE2,1.0,ACTUAL,Weill Medical College of Cornell University,"Due to lower accrual (N=1), there was insufficient data available in order to meet the primary and secondary outcome measures.",1.0,,the study had a low accrual rate,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,OTHER,,,,,,,2021,0.0
NCT03955458,,2019-05-14,,,2020-02-25,2019-05-17,2019-05-20,ACTUAL,,,,,,,2020-02-25,2020-02-27,ACTUAL,2019-08-26,ACTUAL,2019-08-26,2020-02,2020-02-29,2020-05,ESTIMATED,2020-05-31,2020-05,ESTIMATED,2020-05-31,,INTERVENTIONAL,RESTORE,,EXPAREL Facia Iliaca Compartment Block for Intertrochanteric Hip Fracture,"A Phase-4, Multicenter, Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of EXPAREL When Administered Via Fascia Iliaca Compartment Block Versus Fascia Iliaca Compartment Block With Continuous Infusion of Ropivacaine Per Standard of Care Through a Catheter in Intertrochanteric Hip Fracture Patients",WITHDRAWN,,PHASE4,0.0,ACTUAL,"Pacira Pharmaceuticals, Inc",,2.0,,Recruitment difficulties,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,,,,,,2020,0.0
NCT03809481,,2019-01-17,,,2022-12-06,2019-01-17,2019-01-18,ACTUAL,,,,,,,2022-12-06,2022-12-08,ACTUAL,2019-05-16,ACTUAL,2019-05-16,2022-12,2022-12-31,2022-06-10,ACTUAL,2022-06-10,2022-06-10,ACTUAL,2022-06-10,,INTERVENTIONAL,HITSOVA,,"Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study Safety and Efficacy of Danaparoid vs Argatroban","Open-Label, Randomised, Active Controlled, Multi-Centre Ph 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Acute HIT",TERMINATED,,PHASE3,7.0,ACTUAL,Aspen Global Incorporated,,2.0,,Prolonged delay as a result of impact of Covid19 pandemic,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,INDUSTRY,,,,,,,2022,0.0
NCT02890784,,2016-01-14,,,2023-05-09,2016-09-06,2016-09-07,ESTIMATED,,,,,,,2023-05-09,2023-05-10,ACTUAL,2016-08,ACTUAL,2016-08-31,2023-05,2023-05-31,2023-03-31,ACTUAL,2023-03-31,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,DasaHIT,,Dasatinib Holiday for Improved Tolerability,Treatment Optimization for Patients With Chronic Myeloid Leukemia (CML) With Treatment naïve Disease (1st Line) and Patients With Resistance or Intolerance Against Alternative Abl-Kinase Inhibitors (≥2nd Line),COMPLETED,,PHASE3,291.0,ACTUAL,University of Jena,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,OTHER,,,,,,,2023,1.0
NCT03976050,,2019-06-02,,,2020-11-16,2019-06-04,2019-06-05,ACTUAL,,,,,,,2020-11-16,2020-11-18,ACTUAL,2019-06-17,ACTUAL,2019-06-17,2020-11,2020-11-30,2020-11-12,ACTUAL,2020-11-12,2020-11-12,ACTUAL,2020-11-12,,INTERVENTIONAL,,,Phase I Study of HL-085 in Patients With Advanced Solid Tumors,"A Phase I, Single Arm, Dose Escalation Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,4.0,ACTUAL,"Shanghai Kechow Pharma, Inc.",,1.0,,Study objective and design change,f,,,,,t,f,,,,,,,,,,,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,INDUSTRY,,,,,,,2020,0.0
NCT03767829,,2018-12-05,,,2021-04-26,2018-12-05,2018-12-07,ACTUAL,,,,,,,2021-04-26,2021-04-27,ACTUAL,2018-12-05,ACTUAL,2018-12-05,2021-04,2021-04-30,2020-06-25,ACTUAL,2020-06-25,2020-06-25,ACTUAL,2020-06-25,,INTERVENTIONAL,,,A Study of ALN-AAT02 in Healthy Participants and Participants With ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease,"A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Single-ascending and Multiple-dose, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Subcutaneously Administered ALN-AAT02 in Healthy Adult Subjects and Patients With ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease",TERMINATED,,PHASE1/PHASE2,32.0,ACTUAL,Alnylam Pharmaceuticals,,4.0,,The sponsor decided not to proceed with Part B for business reasons.,f,,,,,f,f,,,,,,,,,,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,INDUSTRY,,,,,,,2020,0.0
NCT04834908,,2021-03-23,,,2022-10-12,2021-04-06,2021-04-08,ACTUAL,,,,,,,2022-10-12,2022-10-14,ACTUAL,2021-07-27,ACTUAL,2021-07-27,2022-10,2022-10-31,2022-05-25,ACTUAL,2022-05-25,2022-05-25,ACTUAL,2022-05-25,,INTERVENTIONAL,PROTECT,,Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection,A Prospective Randomized Multi-center Open Label Phase 1/2 Study to Evaluate the Safety and Efficacy of Equine COVID-19 Antiserum [F(ab')2](BSVEQAb) Plus Standard of Care in Comparison to Standard of Care Alone in COVID-19 RT-PCR Positive Patients,TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,Bharat Serums and Vaccines Limited,,2.0,,Closed as no eligible patient.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,INDUSTRY,,,,,,,2022,0.0
NCT03323398,,2017-10-23,2024-07-04,2022-07-07,2024-07-04,2017-10-25,2017-10-27,ACTUAL,2024-07-04,2024-07-31,ACTUAL,2022-07-07,2022-07-11,ACTUAL,2024-07-04,2024-07-31,ACTUAL,2017-08-15,ACTUAL,2017-08-15,2024-06,2024-06-30,2021-08-18,ACTUAL,2021-08-18,2021-08-18,ACTUAL,2021-08-18,,INTERVENTIONAL,,"Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.",Dose Escalation and Efficacy Study of mRNA-2416 for Intratumoral Injection Alone and in Combination With Durvalumab for Participants With Advanced Malignancies,"A Phase 1/2, Open-Label, Multicenter, Dose Escalation and Efficacy Study of mRNA-2416, a Lipid Nanoparticle Encapsulated mRNA Encoding Human OX40L, for Intratumoral Injection Alone or in Combination With Durvalumab for Patients With Advanced Malignancies",TERMINATED,,PHASE1/PHASE2,79.0,ACTUAL,"ModernaTX, Inc.",This study was halted prematurely because the efficacy endpoints were not met for either treatment arm.,2.0,,This study was halted prematurely because the efficacy endpoints were not met for either treatment arm.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,,,,,,2021,0.0
NCT03585725,,2018-05-25,,,2021-09-20,2018-07-11,2018-07-13,ACTUAL,,,,,,,2021-09-20,2021-09-27,ACTUAL,2018-09-26,ACTUAL,2018-09-26,2021-09,2021-09-30,2020-07-22,ACTUAL,2020-07-22,2020-07-22,ACTUAL,2020-07-22,,INTERVENTIONAL,,,A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma,A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma,TERMINATED,,EARLY_PHASE1,3.0,ACTUAL,Weill Medical College of Cornell University,,1.0,,low accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,OTHER,,,,,,,2020,0.0
NCT03978611,,2019-06-05,,,2024-07-23,2019-06-05,2019-06-07,ACTUAL,,,,,,,2024-07-23,2024-07-24,ACTUAL,2021-12-09,ACTUAL,2021-12-09,2024-07,2024-07-31,2023-07-26,ACTUAL,2023-07-26,2023-07-26,ACTUAL,2023-07-26,,INTERVENTIONAL,,,A Study to Assess Safety of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment,"A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy",TERMINATED,,PHASE1,11.0,ACTUAL,Bristol-Myers Squibb,,1.0,,Business objectives have changed.,t,,,,f,t,f,,,,,,,,,,,2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,INDUSTRY,,NCT05170659,NO_LONGER_AVAILABLE,,,,2023,0.0
NCT03474263,,2018-03-09,,,2020-06-22,2018-03-15,2018-03-22,ACTUAL,,,,,,,2020-06-22,2020-06-24,ACTUAL,2019-09-01,ESTIMATED,2019-09-01,2020-06,2020-06-30,2021-07-12,ESTIMATED,2021-07-12,2021-04-12,ESTIMATED,2021-04-12,,INTERVENTIONAL,,,IC14 for Rapidly Progressive Amyotrophic Lateral Sclerosis (ALS),"A Phase 2a, Open-Label Biomarker Study of IC14 for the Treatment of Patients With",WITHDRAWN,,PHASE2,0.0,ACTUAL,Implicit Bioscience,,1.0,,seeking research grant support,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,INDUSTRY,,,,,,,2021,0.0
NCT04717557,,2021-01-13,,2024-07-26,2024-07-26,2021-01-19,2021-01-22,ACTUAL,,,,,2024-07-18,ACTUAL,2024-07-26,2024-08-12,ACTUAL,2021-01-01,ACTUAL,2021-01-01,2024-07,2024-07-31,2023-10-31,ACTUAL,2023-10-31,2023-07-31,ACTUAL,2023-07-31,,INTERVENTIONAL,,,Hyperbaric Oxygen and Outcome After Below Knee Amputations,Hyperbaric Oxygen Therapy to Prevent Complications After Lower Limb Amputation,TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,Duke University,,2.0,,low enrollment,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,OTHER,,,,,,,2023,0.0
NCT02644252,,2015-12-22,,,2021-04-28,2015-12-28,2015-12-31,ESTIMATED,,,,,,,2021-04-28,2021-05-03,ACTUAL,2016-01,ACTUAL,2016-01-31,2021-04,2021-04-30,2021-01-15,ACTUAL,2021-01-15,2019-05-09,ACTUAL,2019-05-09,,INTERVENTIONAL,Toco-Pulm,,Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer,Tocotrienol as a Nutritional Supplement in Patients With Advanced Non-small Cell Lung Cancer (NSCLC),TERMINATED,,PHASE3,79.0,ACTUAL,Vejle Hospital,,4.0,,The trial was ended prematurely because of a poor accrual rate,f,,,,t,,,,,,,,,,,,,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,OTHER,,,,,,,2021,0.0
NCT03845270,,2019-02-14,,,2023-12-18,2019-02-15,2019-02-19,ACTUAL,,,,,,,2023-12-18,2023-12-19,ACTUAL,2019-05-17,ACTUAL,2019-05-17,2023-12,2023-12-31,2023-12-18,ACTUAL,2023-12-18,2021-02-01,ACTUAL,2021-02-01,,INTERVENTIONAL,R2D2,,Her2-positive Lung Cancer Treated With Dedicated Drug,Phase II Trial of Trastuzumab in Combination With Pertuzumab in Pretreated Patients With Non-small Cell Lung Cancer (NSCLC) Harboring a Her2 Mutation and Receiving Docetaxel,COMPLETED,,PHASE2,46.0,ACTUAL,Intergroupe Francophone de Cancerologie Thoracique,,1.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,OTHER,,,,,,,2023,1.0
NCT05175131,,2021-12-14,2022-04-26,,2023-03-21,2021-12-14,2022-01-03,ACTUAL,2023-03-21,2024-01-03,ACTUAL,,,,2023-03-21,2024-01-03,ACTUAL,2020-11-27,ACTUAL,2020-11-27,2023-03,2023-03-31,2021-05-18,ACTUAL,2021-05-18,2021-05-18,ACTUAL,2021-05-18,,INTERVENTIONAL,,,Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders,"Multicenter, Randomized, Parallel-group, Open-label, Comparative Clinical Study to Evaluate Efficacy and Safety of Mebeverine+Simethicone Fixed-dose Combination Versus Duspatalin® (Mebeverine) and Versus Espumisan® (Simethicone) in Patients With Functional Bowel Disorders With Abdominal Pain and Excess Gas Formation",COMPLETED,,PHASE3,465.0,ACTUAL,Abbott,,3.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,INDUSTRY,,,,,,,2021,1.0
NCT03818672,,2019-01-22,2023-11-10,,2023-11-29,2019-01-24,2019-01-28,ACTUAL,2023-11-29,2023-11-30,ACTUAL,,,,2023-11-29,2023-11-30,ACTUAL,2019-01-29,ACTUAL,2019-01-29,2023-11,2023-11-30,2020-02-02,ACTUAL,2020-02-02,2020-02-02,ACTUAL,2020-02-02,,INTERVENTIONAL,,,Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects,Open Label Study to Evaluate the Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy Subjects and Subjects With Severe Hepatic Impairment,TERMINATED,,PHASE4,5.0,ACTUAL,"Bausch Health Americas, Inc.",,1.0,,Study determined to be infeasible.,,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,INDUSTRY,,,,,,,2020,0.0
NCT02970500,,2016-11-18,,,2023-03-21,2016-11-21,2016-11-22,ESTIMATED,,,,,,,2023-03-21,2023-03-23,ACTUAL,2017-10-09,ACTUAL,2017-10-09,2023-03,2023-03-31,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,CogMet,,Effect of Methylphenidate on Cancer-related Cognitive Impairment,Étude Pilote de Phase II Sur l'Effet du méthylphénidate Sur la Fonction Cognitive Des Patientes en rémission d'un Cancer du Sein,TERMINATED,,PHASE2,20.0,ACTUAL,CHU de Quebec-Universite Laval,,2.0,,We decided to close recruitment in December 2022 as we were having trouble recruiting participants who met our inclusion criteria and the study funding was coming to an end.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,OTHER,,,,,,,2022,0.0
NCT03367403,,2017-12-05,2021-12-01,,2022-09-19,2017-12-05,2017-12-08,ACTUAL,2022-01-21,2022-02-15,ACTUAL,,,,2022-09-19,2022-10-13,ACTUAL,2017-12-18,ACTUAL,2017-12-18,2022-09,2022-09-30,2021-09-21,ACTUAL,2021-09-21,2020-12-04,ACTUAL,2020-12-04,,INTERVENTIONAL,,All randomized participants.,A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ),"Assessment of Safety, Tolerability and Efficacy of LY3002813 in Early Symptomatic Alzheimer's Disease",COMPLETED,,PHASE2,272.0,ACTUAL,Eli Lilly and Company,"As per protocol amendment (d) approved on Oct 9, 2018, donanemab in combination with LY3202626 (donanemab-C) arm discontinued as there was a low probability of identifying a statistically significant effect of 12mg of LY3202626 slowing cognitive decline. Clinical efficacy was not reported for this group.",3.0,,,f,,,,t,t,f,,,,,,,,,YES,Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.~This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,INDUSTRY,,,,,,,2021,1.0
NCT04396834,,2020-02-03,2022-04-05,,2023-03-14,2020-05-15,2020-05-21,ACTUAL,2023-03-14,2023-03-20,ACTUAL,,,,2023-03-14,2023-03-20,ACTUAL,2019-12-04,ACTUAL,2019-12-04,2023-03,2023-03-31,2020-02-26,ACTUAL,2020-02-26,2020-02-26,ACTUAL,2020-02-26,,INTERVENTIONAL,,The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.,Mechanisms of Lorcaserin for Smoking Cessation,Behavioral Mechanisms of Lorcaserin Treatment for Smoking Cessation,TERMINATED,,PHASE2,3.0,ACTUAL,The Mind Research Network,,2.0,,Medication removed from the U.S. market by the The Food and Drug Administration,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,OTHER,,,,,,,2020,0.0
NCT03904108,,2019-04-02,2022-03-10,,2022-05-03,2019-04-03,2019-04-04,ACTUAL,2022-05-03,2022-05-26,ACTUAL,,,,2022-05-03,2022-05-26,ACTUAL,2019-06-27,ACTUAL,2019-06-27,2022-04,2022-04-30,2020-07-27,ACTUAL,2020-07-27,2020-07-27,ACTUAL,2020-07-27,,INTERVENTIONAL,,,Platinum-Based Chemotherapy Plus Ramucirumab in Patients With Advanced NSCLC Who Have Progressed on First Line Anti-PD-1 Immunotherapy,Phase-II Trial of Platinum-Based Chemotherapy Plus Ramucirumab in Patients With Advanced NSCLC Who Have Progressed on First Line Anti-PD-1 Immunotherapy,TERMINATED,,PHASE2,3.0,ACTUAL,Stony Brook University,,1.0,,insufficient patient population to complete trial as planned,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,OTHER,,,,,,,2020,0.0
NCT03022097,,2017-01-13,,,2022-05-23,2017-01-13,2017-01-16,ESTIMATED,,,,,,,2022-05-23,2022-05-24,ACTUAL,2017-01-24,ACTUAL,2017-01-24,2022-05,2022-05-31,2022-04-14,ACTUAL,2022-04-14,2022-04-14,ACTUAL,2022-04-14,,INTERVENTIONAL,AVANT,,Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients,"A 24-week Treatment, Randomised, Parallel-group, Double Blinded, Double-Dummy, Multicenter Study to Assess the Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Compared With Individual Components and Placebo and Aclidinium Bromide Compared With Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.",COMPLETED,,PHASE3,1067.0,ACTUAL,AstraZeneca,,4.0,,,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,,,,,,2022,1.0
NCT05510843,,2022-08-18,,,2023-10-04,2022-08-19,2022-08-22,ACTUAL,,,,,,,2023-10-04,2023-10-10,ACTUAL,2022-09-06,ACTUAL,2022-09-06,2023-10,2023-10-31,2023-04-04,ACTUAL,2023-04-04,2023-03-30,ACTUAL,2023-03-30,,INTERVENTIONAL,,,A Study to Evaluate THB001 in Adult Patients With Chronic Cold Urticaria,"An Open-label, Multicenter Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effects of THB001 in Adult Patients With Chronic Cold Urticaria",TERMINATED,,PHASE1,5.0,ACTUAL,"Third Harmonic Bio, Inc.",,3.0,,The decision to discontinue the study was made after observing moderate drug induced liver injury in two subjects enrolled in the first dose cohort.,f,,,,f,f,f,,,,,,Within 1 year after last subject last visit.,,,YES,"Results of safety (AEs, SAEs) will be made available.",2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,INDUSTRY,,,,,,,2023,0.0
NCT04313881,,2020-03-11,2024-02-15,,2024-06-17,2020-03-17,2020-03-18,ACTUAL,2024-03-19,2024-03-21,ACTUAL,,,,2024-06-17,2024-06-27,ACTUAL,2020-09-09,ACTUAL,2020-09-09,2024-06,2024-06-30,2023-09-13,ACTUAL,2023-09-13,2023-09-13,ACTUAL,2023-09-13,,INTERVENTIONAL,ENHANCE,"The Intent-to-treat (ITT) Analysis Set included all participants who were randomized in the study, with treatment assignments designated according to the treatment that participants were randomized to.",Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS),"ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome",TERMINATED,,PHASE3,539.0,ACTUAL,Gilead Sciences,,2.0,,Study discontinued due to futility based on a planned analysis,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,INDUSTRY,,,,,,,2023,0.0
NCT03797066,,2018-10-30,,,2023-05-02,2019-01-07,2019-01-08,ACTUAL,,,,,,,2023-05-02,2023-05-06,ACTUAL,2019-03-23,ACTUAL,2019-03-23,2023-05,2023-05-31,2020-11-30,ACTUAL,2020-11-30,2020-07-28,ACTUAL,2020-07-28,,INTERVENTIONAL,ATTIC,,ATTIC - Access To Treat in the Community,"Localized on -Site Testing and Treatment of Hepatitis C in Homeless Persons in South London: a Pilot Non-randomised Phase 4 Interventional Clinical Trial of Grazoprevir and Elbasvir ± Ribavirin in Participants With Genotype 1a, 1b or 4 to Measure Efficacy and Adherence to Treatment in a Homeless Population",TERMINATED,,PHASE4,13.0,ACTUAL,King's College Hospital NHS Trust,,1.0,,"Changing parameters in HCV management, resulted in poor recruitment; additionally onset of SARS CoV2 resulted in the cessation of all mobile clinical services.",f,,,,f,f,f,,,t,,,,,,NO,"anonymised data sharing only, via publications",2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,OTHER,,,,,,,2020,0.0
NCT02384954,,2015-02-19,2024-04-17,,2024-07-01,2015-03-04,2015-03-10,ESTIMATED,2024-07-01,2024-07-03,ACTUAL,,,,2024-07-01,2024-07-03,ACTUAL,2015-04-17,ACTUAL,2015-04-17,2024-07,2024-07-31,2020-12-13,ACTUAL,2020-12-13,2020-12-13,ACTUAL,2020-12-13,,INTERVENTIONAL,,,QUILT-3.002: N-803 in Patients With Relapse/Refractory iNHL in Conjunction With Rituximab,A Phase 1/2 Study of N-803 in Patients With Relapse/Refractory Indolent B Cell Non-Hodgkin Lymphoma in Conjunction With Rituximab,TERMINATED,,PHASE1/PHASE2,43.0,ACTUAL,Altor BioScience,,9.0,,Change in drug product development strategy.,f,,,,t,,,,,,,,,,,,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,INDUSTRY,,,,,,,2020,0.0
NCT03759639,,2018-11-27,2023-09-18,,2023-11-24,2018-11-28,2018-11-30,ACTUAL,2023-11-24,2023-11-28,ACTUAL,,,,2023-11-24,2023-11-28,ACTUAL,2019-09-04,ACTUAL,2019-09-04,2023-11,2023-11-30,2022-11-07,ACTUAL,2022-11-07,2022-11-07,ACTUAL,2022-11-07,,INTERVENTIONAL,,,"N-Acetyl-L-Leucine for Niemann-Pick Disease, Type C (NPC)","Effects of N-Acetyl-L-Leucine on Niemann Pick Type C Disease: A Multinational, Multicenter, Open-label, Rater-blinded Phase II Study.",COMPLETED,,PHASE2,33.0,ACTUAL,IntraBio Inc,"This study was ongoing during the coronavirus disease 2019 (COVID-19) pandemic, and the conduct of this study was impacted by the COVID-19 pandemic.",2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,INDUSTRY,,,,,,,2022,1.0
NCT04079231,,2019-08-12,,,2021-03-02,2019-09-04,2019-09-06,ACTUAL,,,,,,,2021-03-02,2021-03-04,ACTUAL,2021-02-01,ESTIMATED,2021-02-01,2021-01,2021-01-31,2023-01-31,ESTIMATED,2023-01-31,2023-01-31,ESTIMATED,2023-01-31,,INTERVENTIONAL,BUZZARD,,Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema,"A Comparative Double Masked, Two-Arm, Randomized, Multicenter, Phase IIIb Study Analyzing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (BUZZARD)",WITHDRAWN,,PHASE3,0.0,ACTUAL,Novartis,,2.0,,This study was cancelled due to COVID-19.,f,,,,f,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on ww.clinicalstudydatarequest.com.",2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,INDUSTRY,,,,,,,2023,0.0
NCT03635099,,2018-08-15,2022-05-05,,2022-07-08,2018-08-15,2018-08-17,ACTUAL,2022-05-05,2022-06-02,ACTUAL,,,,2022-07-08,2022-08-03,ACTUAL,2018-09-17,ACTUAL,2018-09-17,2022-07,2022-07-31,2021-05-26,ACTUAL,2021-05-26,2021-05-06,ACTUAL,2021-05-06,,INTERVENTIONAL,,Full Analysis Set (FAS): The FAS includes all patients who received at least 1 dose of trial medication and provided baseline and at least 1 post-randomisation measurement of Psoriasis Area Severity Index (PASI).,This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is,"Phase II Evaluation of Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis",COMPLETED,,PHASE2,274.0,ACTUAL,Boehringer Ingelheim,,8.0,,,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,INDUSTRY,,,,,,,2021,1.0
NCT05403580,,2022-05-19,,,2024-05-03,2022-05-31,2022-06-03,ACTUAL,,,,,,,2024-05-03,2024-05-06,ACTUAL,2022-06-03,ACTUAL,2022-06-03,2024-05,2024-05-31,2024-12,ESTIMATED,2024-12-31,2023-12-29,ACTUAL,2023-12-29,,INTERVENTIONAL,,,Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Patients With Advanced Cancer,"Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated to Chemotherapy or Radiation, in Advanced Cancer Patients - A Confirmatory Phase III MNCCTN Trial",WITHDRAWN,,PHASE3,0.0,ACTUAL,Mayo Clinic,,2.0,,Closed due to slow accrual,f,,,,f,t,f,,,,,,,,,,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,OTHER,,,,,,,2024,0.0
NCT03819153,,2019-01-18,,,2024-08-01,2019-01-25,2019-01-28,ACTUAL,,,,,,,2024-08-01,2024-08-02,ACTUAL,2019-06-17,ACTUAL,2019-06-17,2024-08,2024-08-31,2024-01-09,ACTUAL,2024-01-09,2024-01-09,ACTUAL,2024-01-09,,INTERVENTIONAL,FLOW,,A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease,Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease,COMPLETED,,PHASE3,3508.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,t,t,f,,,,,,,,https://www.novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,INDUSTRY,,,,,,,2024,1.0
NCT03586024,,2018-07-03,,,2021-05-05,2018-07-03,2018-07-13,ACTUAL,,,,,,,2021-05-05,2021-05-07,ACTUAL,2019-03-12,ACTUAL,2019-03-12,2021-04,2021-04-30,2020-08-19,ACTUAL,2020-08-19,2020-08-19,ACTUAL,2020-08-19,,INTERVENTIONAL,,,"Pembrolizumab in Relapsed or Refractory Extranodal NK/T- Cell Lymphoma, Nasal Type and EBV-associated Diffuse Large B Cell Lymphomas","Phase I/II Study of Pembrolizumab in Patients With Relapsed or Refractory Extranodal NK/T- Cell Lymphoma (ENKTL), Nasal Type and EBV-associated Diffuse Large B Cell Lymphomas (EBV-DLBCL)",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Abramson Cancer Center at Penn Medicine,,2.0,,poor accrual,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,OTHER,,,,,,,2020,0.0
NCT04477642,,2020-04-22,,,2020-07-16,2020-07-16,2020-07-20,ACTUAL,,,,,,,2020-07-16,2020-07-20,ACTUAL,2020-08,ESTIMATED,2020-08-31,2020-07,2020-07-31,2020-12,ESTIMATED,2020-12-31,2020-10,ESTIMATED,2020-10-31,,INTERVENTIONAL,,,Abatacept for Patients With COVID-19 and Respiratory Distress,Abatacept for Patients With COVID-19 and Respiratory Distress,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Beth Israel Deaconess Medical Center,,1.0,,Funding,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,OTHER,,,,,,,2020,0.0
NCT04311710,,2020-03-16,,,2023-02-23,2020-03-16,2020-03-17,ACTUAL,,,,,,,2023-02-23,2023-02-24,ACTUAL,2020-06-25,ACTUAL,2020-06-25,2023-02,2023-02-28,2023-01-18,ACTUAL,2023-01-18,2021-01-14,ACTUAL,2021-01-14,,INTERVENTIONAL,CheckMate 76U,,A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types,A Phase 1/2 Pharmacokinetic Multi-tumor Study of Subcutaneous Formulation of Ipilimumab Monotherapy and in Combination With Subcutaneous Nivolumab,TERMINATED,,PHASE1,21.0,ACTUAL,Bristol-Myers Squibb,,4.0,,Business objectives have changed,t,,,,f,t,f,,,,,,,,,,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,INDUSTRY,,NCT02475382,NO_LONGER_AVAILABLE,,,,2023,0.0
NCT03538015,,2018-05-15,2020-08-19,,2020-11-10,2018-05-15,2018-05-25,ACTUAL,2020-08-19,2020-09-09,ACTUAL,,,,2020-11-10,2020-11-25,ACTUAL,2019-04-22,ACTUAL,2019-04-22,2020-11,2020-11-30,2020-08-10,ACTUAL,2020-08-10,2020-08-10,ACTUAL,2020-08-10,,INTERVENTIONAL,,Study was terminated early and there were 0 participants enrolled into the Carvedilol 3.125 mg arm and 0 participants enrolled into the Carvedilol 2.5 mg arm,Carvedilol in Treating Hypoglycemia Unawareness,The Use of Low-Dose Carvedilol to Improve Hypoglycemia Awareness in Patients With Type 1 Diabetes Mellitus,TERMINATED,,PHASE2,1.0,ACTUAL,University of Utah,,3.0,,Sponsor was impacted by COVID-19 and did not have sufficient funds to continue.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,OTHER,,,,,,,2020,0.0
NCT01711515,,2012-10-18,,,2020-09-01,2012-10-18,2012-10-22,ESTIMATED,,,,,,,2020-09-01,2020-09-02,ACTUAL,2012-10-01,ACTUAL,2012-10-01,2020-08,2020-08-31,2020-07-17,ACTUAL,2020-07-17,2017-02-09,ACTUAL,2017-02-09,,INTERVENTIONAL,,,Chemoradiation Therapy and Ipilimumab in Treating Patients With Stages IB2-IIB or IIIB-IVA Cervical Cancer,A Phase I Trial of Sequential Ipilimumab After Chemoradiation for the Primary Treatment of Patients With Locally Advanced Cervical Cancer Stages IB2/IIA With Positive Para-Aortic Lymph Nodes Only and Stage IIB/IIIB/IVA With Positive Lymph Nodes,COMPLETED,,PHASE1,34.0,ACTUAL,National Cancer Institute (NCI),,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,NIH,,,,,,,2020,1.0
NCT03245827,,2017-08-03,2022-05-11,,2022-06-28,2017-08-07,2017-08-10,ACTUAL,2022-06-28,2022-06-29,ACTUAL,,,,2022-06-28,2022-06-29,ACTUAL,2019-04-01,ACTUAL,2019-04-01,2022-06,2022-06-30,2021-10-29,ACTUAL,2021-10-29,2021-10-29,ACTUAL,2021-10-29,,INTERVENTIONAL,,no subjects were recruited in placebo group,Hypogonadotropic Hypogonadism in Obese Young Males,Hypogonadotropic Hypogonadism in Obese Young Males,TERMINATED,,PHASE2,9.0,ACTUAL,St. Louis University,,4.0,,not enough recruitment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,OTHER,,,,,,,2021,0.0
NCT05493501,,2022-06-24,2023-11-01,,2024-04-09,2022-08-05,2022-08-09,ACTUAL,2024-04-09,2024-05-02,ACTUAL,,,,2024-04-09,2024-05-02,ACTUAL,2022-12-14,ACTUAL,2022-12-14,2023-10,2023-10-31,2023-08-31,ACTUAL,2023-08-31,2023-08-31,ACTUAL,2023-08-31,,INTERVENTIONAL,,"Study terminated early, no participants completed the study, no participants were analyzed.",Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer,"A Randomized, Three-Arm, Open-Label Phase 3b Clinical Trial of Aumolertinib, Versus Aumolertinib With Chemotherapy, Versus Osimertinib for Patients With Metastatic NSCLC and an EGFR Mutation (TREBLE)",TERMINATED,,PHASE3,8.0,ACTUAL,"EQRx International, Inc.",,3.0,,The study is being closed based on corporate changes at EQRx and is not related to any efficacy or safety issues with aumolertinib.,f,,,,,t,f,,,,,,,,,,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,,,,,,2023,0.0
NCT02269670,,2014-10-17,2022-01-28,,2022-03-10,2014-10-17,2014-10-21,ESTIMATED,2022-03-10,2022-04-05,ACTUAL,,,,2022-03-10,2022-04-05,ACTUAL,2014-11-25,ACTUAL,2014-11-25,2022-03,2022-03-31,2021-01-25,ACTUAL,2021-01-25,2021-01-25,ACTUAL,2021-01-25,,INTERVENTIONAL,,No data displayed because Outcome Measure has zero total analyzed.,Phase II Study of Everolimus Beyond Progression,"Phase II Study of Everolimus Beyond Progression in Postmenopausal Women With Advanced, Hormone Receptor Positive Breast Cancer",TERMINATED,,PHASE2,3.0,ACTUAL,Emory University,Early termination of the study because of recruitment difficulties lead to insufficient data collection and analysis of primary and secondary outcome measures.,1.0,,Slow to accrual,f,,,,t,,,,,,,,,,,,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,OTHER,,,,,,,2021,0.0
NCT04060862,,2019-08-13,,,2024-04-02,2019-08-15,2019-08-19,ACTUAL,,,,,,,2024-04-02,2024-04-03,ACTUAL,2019-11-15,ACTUAL,2019-11-15,2024-04,2024-04-30,2023-08-29,ACTUAL,2023-08-29,2023-08-29,ACTUAL,2023-08-29,,INTERVENTIONAL,IPATunity150,,A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer,A Phase Ib/III Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer,TERMINATED,,PHASE3,20.0,ACTUAL,Hoffmann-La Roche,,2.0,,The decision to not open the Phase III portion was based on a strategic sponsor decision and not driven by any safety concerns.,f,,,,,t,f,,,,,,,,,NO,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,,,,,,2023,0.0
NCT04548700,,2020-08-28,,,2024-03-05,2020-09-09,2020-09-14,ACTUAL,,,,,,,2024-03-05,2024-03-07,ACTUAL,2020-12-24,ACTUAL,2020-12-24,2020-08,2020-08-31,2023-11-30,ACTUAL,2023-11-30,2023-06-30,ACTUAL,2023-06-30,,INTERVENTIONAL,,,"Liposomal Mitoxantrone Hydrochloride Injection,Cyclophosphamide, Vincristine and Prednisone in the Treatment of PTCL","Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Liposomal Mitoxantrone Hydrochloride Injection Combined With Cyclophosphamide, Vincristine and Prednisone in the Treatment of Untreated PTCL",TERMINATED,,PHASE1,38.0,ACTUAL,"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.",,1.0,,The sponsor has adjusted its R\&D strategy.,f,,,,f,f,f,,,,,,,,,,,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,INDUSTRY,,,,,,,2023,0.0
NCT05096832,,2021-10-21,,,2023-04-22,2021-10-25,2021-10-27,ACTUAL,,,,,,,2023-04-22,2023-04-25,ACTUAL,2021-11-03,ACTUAL,2021-11-03,2023-04,2023-04-30,2023-04-14,ACTUAL,2023-04-14,2022-02-18,ACTUAL,2022-02-18,,INTERVENTIONAL,COVID-19,,Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Booster Study,"A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines",COMPLETED,,PHASE3,10381.0,ACTUAL,Livzon Pharmaceutical Group Inc.,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,,,,,,2023,1.0
NCT02961504,,2016-11-07,,,2024-01-15,2016-11-10,2016-11-11,ESTIMATED,,,,,,,2024-01-15,2024-01-17,ACTUAL,2017-11-15,ACTUAL,2017-11-15,2024-01,2024-01-31,2023-02-28,ACTUAL,2023-02-28,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,TREASURE,,Treatment Evaluation of Acute Stroke for Using in Regenerative Cell Elements,"Placebo-Controlled, Double-Blind, Phase 2/3 Efficacy and Safety Trial of HLCM051 (MultiStem®) in Patients With Ischemic Stroke",COMPLETED,,PHASE2/PHASE3,206.0,ACTUAL,Healios K.K.,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,INDUSTRY,,,,,,,2023,0.0
NCT04617275,,2020-10-30,2022-11-08,,2022-11-08,2020-10-30,2020-11-05,ACTUAL,2022-11-08,2022-12-08,ACTUAL,,,,2022-11-08,2022-12-08,ACTUAL,2021-01-06,ACTUAL,2021-01-06,2022-11,2022-11-30,2021-11-17,ACTUAL,2021-11-17,2021-11-17,ACTUAL,2021-11-17,,INTERVENTIONAL,,A total of 151 participants were assigned to the treatment and treated with danuglipron or placebo.,"A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY","A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06882961 TITRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS TREATED WITH METFORMIN AND IN NON-DIABETIC ADULTS WITH OBESITY",COMPLETED,,PHASE2,151.0,ACTUAL,Pfizer,,7.0,,,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,INDUSTRY,,,,,,,2021,1.0
NCT02959437,,2016-11-07,2020-02-14,,2021-04-13,2016-11-07,2016-11-09,ESTIMATED,2020-02-14,2020-03-05,ACTUAL,,,,2021-04-13,2021-05-06,ACTUAL,2017-02-27,ACTUAL,2017-02-27,2021-04,2021-04-30,2020-03-02,ACTUAL,2020-03-02,2019-02-15,ACTUAL,2019-02-15,,INTERVENTIONAL,,No patients enrolled in Treatment Group B and C.,Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206),"A Phase 1/2 Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Azacitidine in Combination With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors and Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Stage IV Microsatellite-Stable Colorectal Cancer (ECHO-206)",TERMINATED,,PHASE1/PHASE2,70.0,ACTUAL,Incyte Corporation,,3.0,,Study terminated by Sponsor,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,INDUSTRY,,,,,,,2020,0.0
NCT03626012,,2018-08-07,,,2022-01-13,2018-08-07,2018-08-10,ACTUAL,,,,,,,2022-01-13,2022-01-14,ACTUAL,2018-09-10,ACTUAL,2018-09-10,2022-01,2022-01-31,2021-11-17,ACTUAL,2021-11-17,2021-11-17,ACTUAL,2021-11-17,,INTERVENTIONAL,,,"A Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB078 in Adults With C9ORF72-Associated Amyotrophic Lateral Sclerosis","A Phase 1 Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB078 Administered Intrathecally to Adults With C9ORF72-Associated Amyotrophic Lateral Sclerosis",COMPLETED,,PHASE1,106.0,ACTUAL,Biogen,,7.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,INDUSTRY,,,,,,,2021,0.0
NCT04474626,,2020-07-06,,,2021-01-07,2020-07-13,2020-07-17,ACTUAL,,,,,,,2021-01-07,2021-01-11,ACTUAL,2020-12,ESTIMATED,2020-12-31,2021-01,2021-01-31,2024-12-31,ESTIMATED,2024-12-31,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Isoquercetin in Sickle Cell Anemia,Single-arm Phase 2 Study of Oral Isoquercetin in Sickle Cell Disease,WITHDRAWN,,PHASE2,0.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,Trial did not activate,,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,OTHER,,,,,,,2024,0.0
NCT02904304,,2016-03-08,,,2019-07-03,2016-09-15,2016-09-16,ESTIMATED,,,,,,,2019-07-03,2019-07-08,ACTUAL,2020-12,ESTIMATED,2020-12-31,2019-07,2019-07-31,2021-09,ESTIMATED,2021-09-30,2021-07,ESTIMATED,2021-07-31,,INTERVENTIONAL,,,"Desloratadine,Phenylephrine Hcl,Ibuprofen Compared to Placebo in Treatment of Symptoms Associated With Common Cold/Flu","National Clinical Trial,Phase III, Multicenter, Randomized, Prospective, Double-blind, Parallel, Placebo-controlled, to Evaluate the Efficacy, Safety and Superiority of Decongex Gripe in the Treatment of Symptoms Associated With Common Cold",SUSPENDED,,PHASE3,150.0,ESTIMATED,Ache Laboratorios Farmaceuticos S.A.,,2.0,,the viability of the study is being analyzed,f,,,,f,f,f,,,,,,,,,,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,INDUSTRY,,,,,,,2021,0.0
NCT04623086,,2020-11-04,2023-09-06,,2024-02-01,2020-11-04,2020-11-10,ACTUAL,2024-02-01,2024-02-28,ACTUAL,,,,2024-02-01,2024-02-28,ACTUAL,2020-02-14,ACTUAL,2020-02-14,2024-02,2024-02-29,2023-12-31,ACTUAL,2023-12-31,2022-09-07,ACTUAL,2022-09-07,,INTERVENTIONAL,GLIDING,We included all participants who had completed the treatment period in the final analysis. This included wearing the study continuous glucose monitor from time of randomization to study completion and implementing the transition from baseline insulin regimen to degludec (3 doses at least) according to protocol. We did not include subjects who either were Unassigned or Screen Failures as we could not obtain all the baseline characteristics in these two groups of participants.,Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose,"A Randomized Comparison of Transitioning From Insulin GLargine to Insulin Degludec usING a Bridging Dose of Glargine Versus Direct Conversion, in Patients With Type 1 Diabetes Mellitus - a Pilot Study",COMPLETED,,PHASE4,59.0,ACTUAL,University of Washington,,2.0,,,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,OTHER,,,,,,,2023,1.0
NCT04394377,,2020-05-08,,,2021-06-08,2020-05-18,2020-05-19,ACTUAL,,,,,,,2021-06-08,2021-06-10,ACTUAL,2020-06-21,ACTUAL,2020-06-21,2020-05,2020-05-31,2021-05-30,ACTUAL,2021-05-30,2021-03-26,ACTUAL,2021-03-26,,INTERVENTIONAL,ACTION,,Full Anticoagulation Versus Prophylaxis in COVID-19: COALIZAO ACTION Trial,Randomized Clinical Trial to Evaluate a Routine Full Anticoagulation Strategy in Patients With Coronavirus (COVID-19) - COALIZAO ACTION Trial,COMPLETED,,PHASE4,615.0,ACTUAL,Brazilian Clinical Research Institute,,2.0,,,f,,,,t,f,f,,,,,,,,,YES,All data provided during study is anonymized to respect the privacy of patients who have participated in the trial in line with applicable regulations.,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,OTHER,,,,,,,2021,0.0
NCT01697293,,2012-09-13,,,2020-09-22,2012-09-27,2012-10-02,ESTIMATED,,,,,,,2020-09-22,2020-09-24,ACTUAL,2012-01,ACTUAL,2012-01-31,2020-09,2020-09-30,2020-06,ACTUAL,2020-06-30,2020-06,ACTUAL,2020-06-30,,INTERVENTIONAL,,,"PTX-200, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide in Treating Patients With Stage IIB-IV Breast Cancer",A Phase I-II Study of PTX-200 Plus Sequential Weekly Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide in Patients With Metastatic and Locally Advanced Breast Cancer,TERMINATED,,PHASE1/PHASE2,34.0,ACTUAL,"Prescient Therapeutics, Ltd.",,1.0,,criteria for continuing enrollment in Phase 2 portion was not met,f,,,,t,,,,,,,,,,,,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,INDUSTRY,,,,,,,2020,0.0
NCT04115072,,2019-08-22,,,2020-05-15,2019-10-02,2019-10-03,ACTUAL,,,,,,,2020-05-15,2020-05-18,ACTUAL,2019-09-03,ACTUAL,2019-09-03,2020-05,2020-05-31,2020-02-21,ACTUAL,2020-02-21,2020-02-21,ACTUAL,2020-02-21,,INTERVENTIONAL,,,Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study,Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study,COMPLETED,,PHASE2/PHASE3,116.0,ACTUAL,Regionshospital Nordjylland,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,OTHER_GOV,,,,,,,2020,1.0
NCT03922711,,2019-04-17,2022-04-19,,2022-06-07,2019-04-17,2019-04-22,ACTUAL,2022-06-07,2022-07-01,ACTUAL,,,,2022-06-07,2022-07-01,ACTUAL,2019-05-22,ACTUAL,2019-05-22,2022-04,2022-04-30,2020-07-22,ACTUAL,2020-07-22,2020-07-22,ACTUAL,2020-07-22,,INTERVENTIONAL,,"A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.",A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease,"A Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe)",TERMINATED,,PHASE2,23.0,ACTUAL,Prilenia,The study was terminated early due to the COVID-19 pandemic.,3.0,,COVID-19,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,INDUSTRY,,,,,,,2020,0.0
NCT03478904,,2018-03-21,2021-04-12,,2021-04-12,2018-03-24,2018-03-27,ACTUAL,2021-04-12,2021-05-10,ACTUAL,,,,2021-04-12,2021-05-10,ACTUAL,2020-03-10,ACTUAL,2020-03-10,2021-04,2021-04-30,2020-11-30,ACTUAL,2020-11-30,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,,No participants were enrolled to receive Enzalutamide capsule (Treatment A) followed by enzalutamide liquid (Treatment B)~Enzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg)~Enzalutamide Capsule: Enzalutamide gel capsule (4X 40mg),Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single Dose Administration Under Fasting Conditions in Prostate Cancer,Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single Dose Administration Under Fasting Conditions in Prostate Cancer,TERMINATED,,PHASE1,1.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,Study drug is now commercially available in tablet format,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,NIH,,,,,,,2020,0.0
NCT05178342,,2021-11-02,,,2024-08-12,2021-12-16,2022-01-05,ACTUAL,,,,,,,2024-08-12,2024-08-13,ACTUAL,2022-01-01,ACTUAL,2022-01-01,2024-08,2024-08-31,2024-07-31,ACTUAL,2024-07-31,2024-07-31,ACTUAL,2024-07-31,,INTERVENTIONAL,LUCAS,,"Treatment of Anemia in Patients With Very Low, Low or Intermediate Risk Myelodysplastic Syndromes With CA-4948","A Phase II, Open-Label, Multicenter Study of Orally Administered CA-4948 for the Treatment of Anemia in Patients With Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS)",TERMINATED,,PHASE2,38.0,ACTUAL,University of Leipzig,,1.0,,Prematurely according to trial protocol,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,OTHER,,,,,,,2024,0.0
NCT03490838,,2018-03-26,,,2023-03-20,2018-03-30,2018-04-06,ACTUAL,,,,,,,2023-03-20,2023-03-22,ACTUAL,2018-05-24,ACTUAL,2018-05-24,2023-03,2023-03-31,2022-06-02,ACTUAL,2022-06-02,2021-05-26,ACTUAL,2021-05-26,,INTERVENTIONAL,PROter,,"177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer","A Phase 1/2 Open-label, Multi-center, Dose-escalation Study of Safety, Tolerability, Pharmacokinetics, Dosimetry, and Response to Repeat Dosing of 177Lu-PSMA-R2 Radio-ligand Therapy in Patients With Prostate Specific Membrane Antigen (PSMA) Positive (68Ga-PSMA-R2) Progressive Metastatic Castration-resistant Prostate Cancer, Following Previous Systemic Treatment",TERMINATED,,PHASE1,27.0,ACTUAL,Advanced Accelerator Applications,,6.0,,Recruitment for PROter A206T-G01-001 (NCT03490838) was halted in Phase I by sponsor decision. Phase II expansion portion of the study was never initiated.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,INDUSTRY,,,,,,,2022,0.0
NCT04924257,,2021-06-07,,,2022-08-02,2021-06-07,2021-06-11,ACTUAL,,,,,,,2022-08-02,2022-08-05,ACTUAL,2021-07-28,ACTUAL,2021-07-28,2021-06,2021-06-30,2024-04,ESTIMATED,2024-04-30,2023-08,ESTIMATED,2023-08-31,,INTERVENTIONAL,ETES,,ECT vs. Esketamine,"Electroconvulsive Therapy vs. Esketamine Nasal Spray in Treatment-resistant Depression: a Longitudinal, Randomized Efficacy Comparison Pilot Study",WITHDRAWN,,PHASE3,0.0,ACTUAL,Medical University Innsbruck,,2.0,,No eligible participants,f,,,,,f,f,,,,,,,,,,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,OTHER,,,,,,,2024,0.0
NCT04571060,,2020-09-11,2023-02-17,2022-09-21,2023-04-20,2020-09-25,2020-09-30,ACTUAL,2023-03-15,2023-03-16,ACTUAL,,2023-03-16,ACTUAL,2023-04-20,2023-04-24,ACTUAL,2020-10-27,ACTUAL,2020-10-27,2023-04,2023-04-30,2021-10-22,ACTUAL,2021-10-22,2021-10-10,ACTUAL,2021-10-10,,INTERVENTIONAL,,Treated participants included enrolled participants who took the study drug (zavegepant or placebo).,Randomized Trial in Adult Participants With Acute Migraines,"Double-Blind, Randomized, Placebo-controlled, Safety and Efficacy Trial of BHV-3500 (Zavegepant) Intranasal for the Acute Treatment of Migraine",COMPLETED,,PHASE3,1978.0,ACTUAL,Pfizer,,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,INDUSTRY,,,,,,,2021,1.0
NCT03495921,,2018-02-15,2023-01-24,,2023-04-04,2018-04-11,2018-04-12,ACTUAL,2023-04-04,2023-04-26,ACTUAL,,,,2023-04-04,2023-04-26,ACTUAL,2018-08-21,ACTUAL,2018-08-21,2023-04,2023-04-30,2022-01-20,ACTUAL,2022-01-20,2022-01-20,ACTUAL,2022-01-20,,INTERVENTIONAL,VITA,Only 1 subject randomized to Group B was eligible to Cross-over to receive Vigil.,A Trial For Participants With Ewing's Sarcoma Treated With Vigil in Combination With Irinotecan and Temozolomide,"A Multi-Center Phase III, Randomized, Open-Label Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Combination With Irinotecan and Temozolomide as a Second-Line Regimen for Ewing's Sarcoma",TERMINATED,,PHASE3,32.0,ACTUAL,"Gradalis, Inc.",Early termination of trial leading to small numbers of subjects analyzed. Technical problems with measurement leading to unreliable or uninterpretable data.,3.0,,"Slow accrual and as a result, a strategic business decision was made to terminate enrollment.",t,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,NCT03842865,TEMPORARILY_NOT_AVAILABLE,,,,2022,0.0
NCT04040192,,2019-07-30,2022-12-20,,2023-02-07,2019-07-30,2019-07-31,ACTUAL,2023-02-07,2023-03-08,ACTUAL,,,,2023-02-07,2023-03-08,ACTUAL,2019-09-12,ACTUAL,2019-09-12,2023-02,2023-02-28,2022-01-19,ACTUAL,2022-01-19,2022-01-19,ACTUAL,2022-01-19,,INTERVENTIONAL,,Evaluable OL population comprised of all participants who received at least 1 dose of study intervention in the OL period.,A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis,"A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Maintenance Treatment and Flare Reduction With Crisaborole Ointment, 2%, Once Daily Over 52 Weeks in Pediatric and Adult Participants (Ages 3 Months and Older) With Mild-to-Moderate Atopic Dermatitis, Who Responded to Twice Daily Crisaborole Ointment, 2%, Treatment",COMPLETED,,PHASE3,620.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,,,,,,2022,1.0
NCT04381052,,2020-05-06,2022-04-01,,2022-04-06,2020-05-07,2020-05-08,ACTUAL,2022-04-06,2022-04-08,ACTUAL,,,,2022-04-06,2022-04-08,ACTUAL,2020-05-18,ACTUAL,2020-05-18,2022-04,2022-04-30,2021-04-01,ACTUAL,2021-04-01,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,,Study was closed due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.,Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection,A Randomized Placebo-Controlled Safety and Dose-Finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection,TERMINATED,,PHASE2,1.0,ACTUAL,Columbia University,Study was closed due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.,2.0,,Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).,f,,,,t,t,f,,,,,,,,,NO,Coded data will be shared with New York University (NYU) Langone for the purpose of statistical analysis and scientific reporting.,2024-10-14 22:55:34.824949,2024-10-14 22:55:34.824949,OTHER,,,,,,,2021,0.0
NCT03474458,,2018-03-16,,,2024-07-10,2018-03-21,2018-03-22,ACTUAL,,,,,,,2024-07-10,2024-07-11,ACTUAL,2019-02-11,ACTUAL,2019-02-11,2024-07,2024-07-31,2022-05-30,ACTUAL,2022-05-30,2022-05-30,ACTUAL,2022-05-30,,INTERVENTIONAL,,,A Trial of Doxycycline vs. Standard Supportive Therapy in Newly-diagnosed Cardiac AL Amyloidosis Patients Undergoing Bortezomib-based Therapy,A Randomized Phase II/III Trial of Doxycycline vs. Standard Supportive Therapy in Newly-diagnosed Cardiac AL Amyloidosis Patients Undergoing Bortezomib-based Therapy,TERMINATED,,PHASE2/PHASE3,19.0,ACTUAL,Fondazione IRCCS Policlinico San Matteo di Pavia,,2.0,,difficulty in recruitment,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,OTHER,,,,,,,2022,0.0
NCT04830215,,2021-03-29,2023-05-25,,2023-05-25,2021-04-01,2021-04-05,ACTUAL,2023-05-25,2024-02-02,ACTUAL,,,,2023-05-25,2024-02-02,ACTUAL,2021-04-01,ACTUAL,2021-04-01,2023-05,2023-05-31,2022-05-27,ACTUAL,2022-05-27,2022-05-27,ACTUAL,2022-05-27,,INTERVENTIONAL,,The Enrolled Analysis Set included all participants who had signed the informed consent form (ICF) for the trial and had enrolled into the open-label treatment phase.,Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder,"A Phase 4, Multicenter, Open-label, Interventional Trial to Assess the Effects on Engagement of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy for the Treatment of Adults With Major Depressive Disorder",COMPLETED,,PHASE4,122.0,ACTUAL,"Otsuka Pharmaceutical Development & Commercialization, Inc.",,1.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,INDUSTRY,,,,,,,2022,1.0
NCT03444103,,2018-01-16,,,2020-09-06,2018-02-18,2018-02-23,ACTUAL,,,,,,,2020-09-06,2020-09-09,ACTUAL,2018-01-16,ACTUAL,2018-01-16,2020-09,2020-09-30,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,A Pilot Trial of Clazakizumab in Late ABMR,"Safety, Tolerability and Efficacy of Anti-IL-6 Antibody Clazakizumab in Late Antibody-Mediated Rejection After Kidney Transplantation - a Pilot Trial",COMPLETED,,PHASE2,20.0,ACTUAL,Medical University of Vienna,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,OTHER,,,,,,,2020,1.0
NCT04447235,,2020-06-22,,,2022-08-05,2020-06-23,2020-06-25,ACTUAL,,,,,,,2022-08-05,2022-08-09,ACTUAL,2020-07-23,ACTUAL,2020-07-23,2022-08,2022-08-31,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,TITAN,,Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection,"Randomized, Doubled-blind Phase II Trial Evaluating the Use of Ivermectin Plus Losartan for Prophylaxis of Severe Events in Cancer Patients With Recent Diagnosis of COVID-19",TERMINATED,,PHASE2,77.0,ACTUAL,Instituto do Cancer do Estado de São Paulo,,2.0,,futility analysis has demonstrated no difference between arms,f,,,,t,f,f,,,f,,,,,,NO,no plan to share individual participant data,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,OTHER,,,,,,,2022,0.0
NCT04910152,,2021-04-24,,,2024-04-23,2021-05-28,2021-06-02,ACTUAL,,,,,,,2024-04-23,2024-04-25,ACTUAL,2022-04-19,ACTUAL,2022-04-19,2024-04,2024-04-30,2023-09-28,ACTUAL,2023-09-28,2023-09-28,ACTUAL,2023-09-28,,INTERVENTIONAL,,,Novel BET Inhibitor PLX51107 for Steroid-Refractory Acute GVHD,"A Single Arm, Open Label, Phase 1b/2 Study of Novel BET Inhibitor PLX51107 for Steroid-Refractory Acute GVHD",TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,Ohio State University Comprehensive Cancer Center,,1.0,,Sponsor decision,,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,OTHER,,,,,,,2023,0.0
NCT03528876,,2018-05-01,,,2020-10-29,2018-05-16,2018-05-18,ACTUAL,,,,,,,2020-10-29,2020-11-02,ACTUAL,2018-09-01,ACTUAL,2018-09-01,2020-10,2020-10-31,2020-10-29,ACTUAL,2020-10-29,2020-10-29,ACTUAL,2020-10-29,,INTERVENTIONAL,LOGIC,,FOLFIRI Alternate With FOLFOX in Untreated Metastatic Gastric and Esophageal Adenocarcinoma,FOLFIRI Alternate With FOLFOX in Untreated Metastatic Gastric and Esophageal Adenocarcinoma. The LOGIC Study,TERMINATED,,PHASE2,36.0,ACTUAL,University of Saskatchewan,,1.0,,Combination of chemotherapy and Immunotherapy is a new Standard of care,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,OTHER,,,,,,,2020,0.0
NCT05070312,,2021-07-27,,,2022-03-24,2021-09-27,2021-10-07,ACTUAL,,,,,,,2022-03-24,2022-03-25,ACTUAL,2021-08-23,ACTUAL,2021-08-23,2022-03,2022-03-31,2022-02-07,ACTUAL,2022-02-07,2022-02-07,ACTUAL,2022-02-07,,INTERVENTIONAL,,,"Pharmacokinetics, Immunogenicity, Safety and Tolerability of MEDI3506 in Health Chinese Participants","A Phase I, Randomized, Double-blind, Placebo-controlled, Dose-ascending Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of MEDI3506 in Healthy Chinese Participants",COMPLETED,,PHASE1,39.0,ACTUAL,AstraZeneca,,3.0,,,f,,,,,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessor) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,INDUSTRY,,,,,,,2022,1.0
NCT04837131,,2021-04-05,,,2024-04-25,2021-04-06,2021-04-08,ACTUAL,,,,,,,2024-04-25,2024-04-26,ACTUAL,2021-04-28,ACTUAL,2021-04-28,2024-04,2024-04-30,2024-02-23,ACTUAL,2024-02-23,2024-02-23,ACTUAL,2024-02-23,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Tolerability of Oral Ixazomib in Scleroderma-related Lung Disease Patients,A Phase 2 Open-Label Pilot Study of the Safety and Tolerability of Ixazomib Administered Orally to Patients With Scleroderma-Related Interstitial Lung Disease,TERMINATED,,PHASE2,3.0,ACTUAL,Mayo Clinic,,1.0,,Low enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,OTHER,,,,,,,2024,0.0
NCT04474197,,2020-07-13,2022-05-03,,2022-05-03,2020-07-13,2020-07-16,ACTUAL,2022-05-03,2022-05-26,ACTUAL,,,,2022-05-03,2022-05-26,ACTUAL,2020-07-24,ACTUAL,2020-07-24,2022-05,2022-05-31,2021-05-04,ACTUAL,2021-05-04,2021-05-04,ACTUAL,2021-05-04,,INTERVENTIONAL,,,Evaluation of the Efficacy and Safety of VX-864 in Subjects With the PiZZ Genotype,"A Phase 2, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of VX-864 in PiZZ Subjects",COMPLETED,,PHASE2,44.0,ACTUAL,Vertex Pharmaceuticals Incorporated,,4.0,,,f,,,,,t,f,,,,,,,,,NO,Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,INDUSTRY,,,,,,,2021,1.0
NCT03998514,,2019-06-21,,,2021-05-10,2019-06-25,2019-06-26,ACTUAL,,,,,,,2021-05-10,2021-05-11,ACTUAL,2018-07-09,ACTUAL,2018-07-09,2021-05,2021-05-31,2021-04-19,ACTUAL,2021-04-19,2021-04-19,ACTUAL,2021-04-19,,INTERVENTIONAL,,,A Phase 1a/1b Study of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease,"A Phase 1a/1b Study of Safety, Tolerability, and Pharmacokinetics of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease",COMPLETED,,PHASE1,88.0,ACTUAL,"CohBar, Inc.",,10.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,INDUSTRY,,,,,,,2021,1.0
NCT04546425,,2020-08-21,2023-04-19,,2024-01-05,2020-09-04,2020-09-14,ACTUAL,2023-04-19,2023-05-15,ACTUAL,,,,2024-01-05,2024-01-08,ACTUAL,2020-09-09,ACTUAL,2020-09-09,2024-01,2024-01-31,2023-02-18,ACTUAL,2023-02-18,2022-04-22,ACTUAL,2022-04-22,,INTERVENTIONAL,,Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose.,20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants,"A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS",COMPLETED,,PHASE3,1258.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,INDUSTRY,,,,,,,2023,1.0
NCT03071692,,2017-02-23,,2023-07-11,2023-07-11,2017-03-01,2017-03-07,ACTUAL,,,,,2023-07-13,ACTUAL,2023-07-11,2023-07-13,ACTUAL,2017-03-23,ACTUAL,2017-03-23,2023-07,2023-07-31,2022-07-27,ACTUAL,2022-07-27,2022-07-27,ACTUAL,2022-07-27,,INTERVENTIONAL,PROMINENT,,Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT),Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT),TERMINATED,,PHASE3,10544.0,ACTUAL,"Kowa Research Institute, Inc.",,2.0,,The study was stopped for futility based on efficacy results at the interim analysis; no unexpected safety findings were observed.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,INDUSTRY,,,,,,,2022,0.0
NCT05331053,,2022-04-08,2023-11-27,,2024-02-05,2022-04-08,2022-04-15,ACTUAL,2024-02-05,2024-02-28,ACTUAL,,,,2024-02-05,2024-02-28,ACTUAL,2018-05-01,ACTUAL,2018-05-01,2024-02,2024-02-29,2024-08-31,ESTIMATED,2024-08-31,2022-06-01,ACTUAL,2022-06-01,,INTERVENTIONAL,,,MicroRNA Activation of LOX-1 Mechanisms in Endometriosis,MicroRNA Activation of LOX-1 Mechanisms in Endometriosis,SUSPENDED,,PHASE4,6.0,ACTUAL,Penn State University,,1.0,,COVID halting human subjects research and preliminary data from this proposal were used to submit an NIH grant. The NIH grant was funded and 3 other protocols were launched.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,OTHER,,,,,,,2024,0.0
NCT03812029,,2019-01-17,2022-11-16,,2023-04-13,2019-01-18,2019-01-22,ACTUAL,2023-04-13,2023-05-06,ACTUAL,,,,2023-04-13,2023-05-06,ACTUAL,2019-01-30,ACTUAL,2019-01-30,2023-04,2023-04-30,2021-07-06,ACTUAL,2021-07-06,2021-06-16,ACTUAL,2021-06-16,,INTERVENTIONAL,,"For Part A, data from the 3 vonafexor treatment groups were pooled and summarized. Due to the small number of subjects by treatment group in Part A, and as the Study EYP001 202 Part A PK results between groups were found to be nonlinear with similar exposure for the vonafexor 200 mg QD and vonafexor 400 mg QD groups, only the pooled vonafexor treatment group were compared with the placebo group.","Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH)","A Phase 2a, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis",COMPLETED,,PHASE2,120.0,ACTUAL,Enyo Pharma,,5.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,INDUSTRY,,,,,,,2021,1.0
NCT02420912,,2015-04-15,2023-02-16,,2024-02-21,2015-04-15,2015-04-20,ESTIMATED,2024-02-21,2024-03-20,ACTUAL,,,,2024-02-21,2024-03-20,ACTUAL,2015-06-19,ACTUAL,2015-06-19,2024-02,2024-02-29,2022-02-14,ACTUAL,2022-02-14,2022-02-14,ACTUAL,2022-02-14,,INTERVENTIONAL,,,"Nivolumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or High-Risk Untreated Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Richter Transformation","Nivolumab Combined With Ibrutinib for Relapsed, Refractory or High-Risk Untreated Patients With Chronic Lymphocytic Leukemia (CLL)",COMPLETED,,PHASE2,37.0,ACTUAL,M.D. Anderson Cancer Center,,3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,OTHER,,,,,,,2022,1.0
NCT04795596,,2021-03-09,,,2022-04-09,2021-03-09,2021-03-12,ACTUAL,,,,,,,2022-04-09,2022-04-15,ACTUAL,2021-04-01,ACTUAL,2021-04-01,2022-04,2022-04-30,2022-04-09,ACTUAL,2022-04-09,2022-04-09,ACTUAL,2022-04-09,,INTERVENTIONAL,,,Secondary Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancers,Clinical Outcomes of Secondary Cytoreductive Surgery in Platinum-resistant Ovarian Cancers With Isolated Recurrence,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Menoufia University,,2.0,,Poor accrual,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,OTHER,,,,,,,2022,0.0
NCT01998841,,2013-11-22,2023-07-11,,2024-07-29,2013-11-25,2013-12-02,ESTIMATED,2023-08-28,2023-09-22,ACTUAL,,,,2024-07-29,2024-07-30,ACTUAL,2013-12-20,ACTUAL,2013-12-20,2024-07,2024-07-31,2023-08-08,ACTUAL,2023-08-08,2022-03-22,ACTUAL,2022-03-22,,INTERVENTIONAL,,Intent-to-Treat (ITT) population included all randomized participants whether or not the participants received the assigned study treatment.,"A Study of Crenezumab Versus Placebo in Preclinical Presenilin1 (PSEN1) E280A Mutation Carriers to Evaluate Efficacy and Safety in the Treatment of Autosomal-Dominant Alzheimer's Disease (AD), Including a Placebo-Treated Non-Carrier Cohort","A Double-Blind, Placebo-Controlled Parallel-Group Study in Preclinical PSEN1 E280A Mutation Carriers Randomized to Crenezumab or Placebo, and in Non-Randomized, Placebo-Treated Non-Carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Crenezumab in the Treatment of Autosomal-Dominant Alzheimer's Disease",COMPLETED,,PHASE2,252.0,ACTUAL,"Genentech, Inc.",,3.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,,,,,,2023,1.0
NCT00989651,,2009-10-02,,,2021-10-19,2009-10-02,2009-10-05,ESTIMATED,,,,,,,2021-10-19,2021-10-20,ACTUAL,2009-10-28,ACTUAL,2009-10-28,2021-10,2021-10-31,2020-04-10,ACTUAL,2020-04-10,2016-09-02,ACTUAL,2016-09-02,,INTERVENTIONAL,,,"Carboplatin, Paclitaxel, Bevacizumab, and Veliparib in Treating Patients With Newly Diagnosed Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer","A Phase I Study of Intravenous Carboplatin/Paclitaxel or Intravenous and Intraperitoneal Paclitaxel/Cisplatin in Combination With Continuous or Intermittent /CTEP-Supplied Agent ABT-888 (NSC #737664) and CTEP-Supplied Agent Bevacizumab (NSC #704865) in Newly Diagnosed Patients With Previously Untreated Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer",COMPLETED,,PHASE1,431.0,ACTUAL,National Cancer Institute (NCI),,3.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,NIH,,,,,,,2020,1.0
NCT04427072,,2020-06-09,,,2024-07-16,2020-06-09,2020-06-11,ACTUAL,,,,,,,2024-07-16,2024-07-18,ACTUAL,2020-09-25,ACTUAL,2020-09-25,2024-07,2024-07-31,2023-11-06,ACTUAL,2023-11-06,2023-02-15,ACTUAL,2023-02-15,,INTERVENTIONAL,GeoMETry-III,,Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation,"A Phase III, Randomized, Controlled, Open-label, Multicenter, Global Study of Capmatinib Versus SoC Docetaxel Chemotherapy in Previously Treated Patients With EGFR wt, ALK Negative, Locally Advanced or Metastatic (Stage IIIB/IIIC or IV) NSCLC Harboring MET Exon 14 Skipping Mutation (METΔex14).",COMPLETED,,PHASE3,22.0,ACTUAL,Novartis,,2.0,,,f,,,,f,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,,,,,,2023,0.0
NCT05013008,,2021-07-20,2022-12-18,,2023-09-14,2021-08-18,2021-08-19,ACTUAL,2023-03-07,2023-03-31,ACTUAL,,,,2023-09-14,2023-09-15,ACTUAL,2021-08-18,ACTUAL,2021-08-18,2023-09,2023-09-30,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,FIGARO-BM,"Modified biomarker full analysis set (mBFAS): All participants with valid informed consent for this biomarker study, which met the following criteria: a. Study enrollment criteria as defined in the study protocol. b. Analyzed biomarker samples at Visit 3 (4 months) and Visit 11 (36 months); Biomarker samples that were shipped at ambient temperatures were not analyzed. c. On Treatment at Visit 3 and Visit 11.","An add-on Study to the FIGARO-DKD Study Called FIGARO-BM to Learn About the Link Between Biomarkers (Substances in the Blood Used as Indicators of Biological Processes, Disease Processes or Responses to Medication) and Finerenone in FIGARO-DKD Participants",A Non-blinded Retrospective Biomarker add-on Study to FIGARO-DKD for Bioprofiling the Pharmacodynamic Response to Finerenone in FIGARO-DKD Subjects,COMPLETED,,PHASE2,951.0,ACTUAL,Bayer,"This study was a retrospective, add-on study to the multi-center, interventional Phase 3 study FIGARO-DKD (NCT02545049). Blood plasma samples that were originally collected for PK analysis during the conduct of FIGARO-DKD study. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD.",2.0,,,f,,,,f,t,f,,,f,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,,,,,,2021,1.0
NCT02236572,,2014-09-08,2021-10-22,,2022-01-12,2014-09-09,2014-09-10,ESTIMATED,2022-01-12,2022-02-01,ACTUAL,,,,2022-01-12,2022-02-01,ACTUAL,2014-11-29,ACTUAL,2014-11-29,2022-01,2022-01-31,2021-03-01,ACTUAL,2021-03-01,2021-03-01,ACTUAL,2021-03-01,,INTERVENTIONAL,,,"Neoadj ph 2 AI Plus Everolimus in Postmenopausal Women w/ ER Pos/HER2 Neg, Low Risk Score",A Neoadjuvant Phase II Trial of Aromatase Inhibitors in Combination With Everolimus in Postmenopausal Women With Hormone Receptor Positive/HER2 Negative Breast Cancers With Low and Intermediate Risk (< 25) Oncotype Dx Recurrence Scores,TERMINATED,,PHASE2,17.0,ACTUAL,Yale University,,1.0,,"Phase 2 of recruitment was contingent on 5 of 15 patients responding, which did not occur.",f,,,,t,,,,,,,,,,,,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,OTHER,,,,,,,2021,0.0
NCT03335436,,2017-10-09,,,2019-02-14,2017-11-02,2017-11-07,ACTUAL,,,,,,,2019-02-14,2019-02-18,ACTUAL,2018-04-01,ACTUAL,2018-04-01,2019-02,2019-02-28,2020-12,ESTIMATED,2020-12-31,2020-11,ESTIMATED,2020-11-30,,INTERVENTIONAL,,,Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient,"A Randomized, Double-blind, Placebo-controlled Trial of Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient",WITHDRAWN,,PHASE4,0.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,Lack of enrollment,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,OTHER,,,,,,,2020,0.0
NCT05446168,,2022-07-01,,,2023-11-01,2022-07-01,2022-07-06,ACTUAL,,,,,,,2023-11-01,2023-11-07,ACTUAL,2022-07-01,ACTUAL,2022-07-01,2023-11,2023-11-30,2023-09-26,ACTUAL,2023-09-26,2023-09-26,ACTUAL,2023-09-26,,INTERVENTIONAL,BUTTER,,Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation,Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation,TERMINATED,,PHASE1,18.0,ACTUAL,University of Michigan,,2.0,,Withdrawal of funding,,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,OTHER,,,,,,,2023,0.0
NCT04529954,,2020-08-25,,,2024-03-11,2020-08-25,2020-08-28,ACTUAL,,,,,,,2024-03-11,2024-03-13,ACTUAL,2021-01-01,ACTUAL,2021-01-01,2024-03,2024-03-31,2024-03-01,ACTUAL,2024-03-01,2024-03-01,ACTUAL,2024-03-01,,INTERVENTIONAL,,,Anti-Epilepsy Medication Valproate Administered Via ICV Route and Catheters and Pumps for CSF Infusion,"An Open-Label Extension Study to Investigate the Long-Term Safety, and Tolerability of Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Focal Seizures, With Temporal Lobe Onset With or Without Secondary Generalization",TERMINATED,,PHASE1/PHASE2,20.0,ACTUAL,Cerebral Therapeutics LLC,,1.0,,Company Decision,f,,,,f,f,f,,,t,,,,,,NO,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,,,,,,2024,0.0
NCT03907969,,2019-02-21,2023-11-22,,2024-01-10,2019-04-05,2019-04-09,ACTUAL,2024-01-10,2024-02-06,ACTUAL,,,,2024-01-10,2024-02-06,ACTUAL,2019-10-09,ACTUAL,2019-10-09,2024-01,2024-01-31,2022-12-07,ACTUAL,2022-12-07,2022-12-07,ACTUAL,2022-12-07,,INTERVENTIONAL,,All patients who received at least 1 dose of any study treatment.,A Clinical Trial to Evaluate AZD7648 Alone and in Combination With Other Anti-cancer Agents in Patients With Advanced Cancers.,"A Phase I/IIa, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD7648 Monotherapy or in Combination With Either Cytotoxic Chemotherapies or Novel Anti-Cancer Agents in Patients With Advanced Malignancies",COMPLETED,,PHASE1/PHASE2,30.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,INDUSTRY,,,,,,,2022,0.0
NCT04139395,,2019-10-23,,,2022-08-18,2019-10-23,2019-10-25,ACTUAL,,,,,,,2022-08-18,2022-08-22,ACTUAL,2019-01-15,ACTUAL,2019-01-15,2022-08,2022-08-31,2021-12-20,ESTIMATED,2021-12-20,2020-12-20,ESTIMATED,2020-12-20,,INTERVENTIONAL,,,68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO),68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO),WITHDRAWN,,PHASE3,0.0,ACTUAL,Stanford University,,1.0,,Not feasible at this time.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,OTHER,,,,,,,2021,0.0
NCT03689972,,2018-09-27,2024-01-31,,2024-05-14,2018-09-27,2018-10-01,ACTUAL,2024-05-14,2024-06-12,ACTUAL,,,,2024-05-14,2024-06-12,ACTUAL,2018-11-27,ACTUAL,2018-11-27,2024-05,2024-05-31,2023-07-24,ACTUAL,2023-07-24,2023-01-31,ACTUAL,2023-01-31,,INTERVENTIONAL,,Part 1: All randomized population included all the randomized participants in Part 1 of the study. Part 2: Included all the newly enrolled randomized participants in the crossover period of Part 2 of the study.,"A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration","A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration",COMPLETED,,PHASE3,585.0,ACTUAL,Biogen,,5.0,,,f,,,,f,t,f,,,,,,,,,NO,Please refer data queries to DataSharing@biogen.com.,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,INDUSTRY,,,,,,,2023,1.0
NCT05942820,,2023-07-05,,,2024-03-19,2023-07-05,2023-07-12,ACTUAL,,,,,,,2024-03-19,2024-03-20,ACTUAL,2023-08-30,ACTUAL,2023-08-30,2024-03,2024-03-31,2024-02-15,ACTUAL,2024-02-15,2024-01-30,ACTUAL,2024-01-30,,INTERVENTIONAL,,,"The Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of BWC0977 in Healthy Adult Volunteers","A Randomized, Double-blind, Placebo-controlled, Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of BWC0977 in Healthy Adult Volunteers",TERMINATED,,PHASE1,4.0,ACTUAL,Bugworks Research Inc.,,2.0,,CMC challenges,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,INDUSTRY,,,,,,,2024,0.0
NCT04968184,,2021-07-07,,2024-08-07,2024-08-09,2021-07-07,2021-07-20,ACTUAL,,,,,2024-07-23,ACTUAL,2024-08-09,2024-08-13,ACTUAL,2021-11-05,ACTUAL,2021-11-05,2024-08,2024-08-31,2024-07-10,ACTUAL,2024-07-10,2024-01-30,ACTUAL,2024-01-30,,INTERVENTIONAL,Clarion-CKD,,Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe Chronic Kidney Disease (CKD),A Phase 3 Randomized Double-Blind Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of KBP-5074 Mineralocorticoid Receptor Antagonist in Subjects With Uncontrolled Hypertension and Moderate or Severe (Stage 3b/4) CKD,TERMINATED,,PHASE3,652.0,ACTUAL,KBP Biosciences,,2.0,,Interim futility analysis showed primary endpoint not achieved,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,,,,,,2024,0.0
NCT04542213,,2020-09-03,,,2021-03-19,2020-09-04,2020-09-09,ACTUAL,,,,,,,2021-03-19,2021-03-23,ACTUAL,2020-08-01,ACTUAL,2020-08-01,2021-03,2021-03-31,2021-02-28,ACTUAL,2021-02-28,2021-02-28,ACTUAL,2021-02-28,,INTERVENTIONAL,Covid19DPP4i,,Dipeptidyl Peptidase-4 Inhibitor (DPP4i) for the Control of Hyperglycemia in Patients With COVID-19,Effect of the Combination of Dipeptidyl Peptidase-4 Inhibitor (DPP4i) and Insulin in Comparison to Insulin on Metabolic Control and Prognosis in Hospitalized Patients With COVID-19,COMPLETED,,PHASE3,70.0,ACTUAL,Hospital Regional de Alta Especialidad del Bajio,,2.0,,,f,,,,t,f,f,,,,,,"Data will be available once the main results of the study are published, and in accordance with the journal",Direct contact with the principal investigator,,YES,"Sharing of the data can be done, depending on the requested purposes",2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,OTHER,,,,,,,2021,1.0
NCT02756845,,2015-12-15,2023-02-09,,2024-02-15,2016-04-27,2016-04-29,ESTIMATED,2023-05-26,2024-02-05,ACTUAL,,,,2024-02-15,2024-02-20,ACTUAL,2017-08-16,ACTUAL,2017-08-16,2024-02,2024-02-29,2022-11-29,ACTUAL,2022-11-29,2022-01-17,ACTUAL,2022-01-17,,INTERVENTIONAL,,All enrolled participants.,Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors,"A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Non Central Nervous System Tumors That Are Amenable to Direct Injection",COMPLETED,,PHASE1,15.0,ACTUAL,Amgen,Participant recruitment ended when 15 participants were enrolled due to difficulties in enrollment.,1.0,,,f,,,,t,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,INDUSTRY,,,,,,,2022,1.0
NCT03602118,,2018-07-17,,,2019-08-26,2018-07-25,2018-07-26,ACTUAL,,,,,,,2019-08-26,2019-08-28,ACTUAL,2019-11,ESTIMATED,2019-11-30,2019-08,2019-08-31,2021-08-01,ESTIMATED,2021-08-01,2021-05-01,ESTIMATED,2021-05-01,,INTERVENTIONAL,,,Study to Evaluate Phenobarbital Sodium Injection for the Treatment of Neonatal Seizures,"A Randomized, Double-blind, Parallel Group, Phase 3 Study to Evaluate the Efficacy of Phenobarbital Sodium Injection for the Treatment of Neonatal Seizures",WITHDRAWN,,PHASE3,0.0,ACTUAL,"PharPoint Research, Inc.",,2.0,,Sponsor withdrawing the subject IND,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,INDUSTRY,,,,,,,2021,0.0
NCT01903473,,2013-07-10,,,2022-09-19,2013-07-16,2013-07-19,ESTIMATED,,,,,,,2022-09-19,2022-09-22,ACTUAL,2013-07,ACTUAL,2013-07-31,2022-09,2022-09-30,2022-09-12,ACTUAL,2022-09-12,2022-09-12,ACTUAL,2022-09-12,,INTERVENTIONAL,,,Donor Regulatory T Cells Infusion in Patients With Chronic Graft-versus-host Disease (GVHD),Donor Regulatory T Cells (Treg) Infusion (DTI) in Patients With Steroid-refractory Chronic Graft-versus-host Disease (GVHD),TERMINATED,,PHASE2,19.0,ACTUAL,University of Liege,,2.0,,slow recruitment,f,,,,f,,,,,,,,,,,,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,OTHER,,,,,,,2022,0.0
NCT02740114,,2016-04-12,2021-07-07,,2021-09-21,2016-04-12,2016-04-15,ESTIMATED,2021-08-27,2021-09-22,ACTUAL,,,,2021-09-21,2021-10-18,ACTUAL,2016-08-31,ACTUAL,2016-08-31,2021-09,2021-09-30,2020-07-23,ACTUAL,2020-07-23,2020-07-23,ACTUAL,2020-07-23,,INTERVENTIONAL,,,Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway,"Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway: A Single-Blinded, Randomized, Controlled Study",TERMINATED,,PHASE3,105.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,Per PIs request,f,,,,t,t,f,,,,,,,,,,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,OTHER,,,,,,,2020,0.0
NCT03960125,,2019-05-20,,,2022-09-07,2019-05-20,2019-05-22,ACTUAL,,,,,,,2022-09-07,2022-09-13,ACTUAL,2021-03-29,ACTUAL,2021-03-29,2022-09,2022-09-30,2022-09,ESTIMATED,2022-09-30,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,,,Photodynamic Therapy and Microvesicles,Photodynamic Therapy and Microvesicles,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Wright State University,,2.0,,The PI decided to move in another direction with his research.,f,,,,,t,t,,,t,,,,,,,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,OTHER,,,,,,,2022,0.0
NCT04137289,,2019-10-22,,,2024-01-11,2019-10-22,2019-10-24,ACTUAL,,,,,,,2024-01-11,2024-01-12,ACTUAL,2020-03-11,ACTUAL,2020-03-11,2024-01,2024-01-31,2023-11-27,ACTUAL,2023-11-27,2023-07-26,ACTUAL,2023-07-26,,INTERVENTIONAL,,,A Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer,"A First-in-human Phase Ia/b, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Patients With Advanced Gastrointestinal Cancers",COMPLETED,,PHASE1,110.0,ACTUAL,Boehringer Ingelheim,,5.0,,,f,,,,f,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.",2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,INDUSTRY,,,,,,,2023,1.0
NCT03559517,,2018-05-09,2021-04-02,,2021-04-02,2018-06-05,2018-06-18,ACTUAL,2021-04-02,2021-04-29,ACTUAL,,,,2021-04-02,2021-04-29,ACTUAL,2018-08-29,ACTUAL,2018-08-29,2021-04,2021-04-30,2020-10-08,ACTUAL,2020-10-08,2020-07-07,ACTUAL,2020-07-07,,INTERVENTIONAL,CARMEN CD 305,The safety set consisted of all participants who had received at least 1 dose of study treatment.,Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305),"A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 305)",TERMINATED,,PHASE3,30.0,ACTUAL,Takeda,The study was terminated as the sponsor discontinued the ontamalimab clinical trial program in ulcerative colitis and CD for reasons unrelated to safety.,3.0,,Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.,f,,,,t,t,f,,,,,,,,,,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,INDUSTRY,,,,,,,2020,0.0
NCT04848467,,2021-04-16,,,2021-08-04,2021-04-16,2021-04-19,ACTUAL,,,,,,,2021-08-04,2021-08-11,ACTUAL,2021-10-01,ESTIMATED,2021-10-01,2021-08,2021-08-31,2022-11-15,ESTIMATED,2022-11-15,2021-11-30,ESTIMATED,2021-11-30,,INTERVENTIONAL,CV-NCOV-011,,"COVID-19: A Trial Studying the SARS-CoV-2 mRNA Vaccine CVnCoV to Learn About the Immune Response, the Safety, and the Degree of Typical Vaccination Reactions When CVnCoV is Given at the Same Time as a Flu Vaccine Compared to When the Vaccines Are Separately Given in Adults 60 Years of Age and Older","COVID-19: A Phase 3, Randomized, Observer-blinded, Multicenter Clinical Study Evaluating the Immunogenicity, Safety, and Reactogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV, When Co-administered With a Licensed Quadrivalent Influenza Vaccine Versus Separate Administration of the Two Vaccines in Adults 60 Years of Age and Older",WITHDRAWN,,PHASE3,0.0,ACTUAL,Bayer,,2.0,,The study cannot be conducted.,f,,,,t,f,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,INDUSTRY,,,,,,,2022,0.0
NCT04404790,,2020-05-26,,,2020-05-26,2020-05-26,2020-05-28,ACTUAL,,,,,,,2020-05-26,2020-05-28,ACTUAL,2020-09,ESTIMATED,2020-09-30,2020-05,2020-05-31,2021-05,ESTIMATED,2021-05-31,2021-03,ESTIMATED,2021-03-31,,INTERVENTIONAL,,,Antiplatelet Thrombolysin (Anfibatide) Phase 1 Clinical Trial in Healthy Volunteers,Phase I Clinical Trial of the Tolerance and Pharmacokinetics of Anfibatide in Health Volunteer,SUSPENDED,,PHASE1,50.0,ESTIMATED,Lee's Pharmaceutical Limited,,8.0,,Optimization of protocol,f,,,,f,f,f,,,,,,,,,,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,INDUSTRY,,,,,,,2021,0.0
NCT02180204,,2014-06-21,,,2015-09-22,2014-06-30,2014-07-02,ESTIMATED,,,,,,,2015-09-22,2015-09-23,ESTIMATED,2015-01,,2015-01-31,2015-09,2015-09-30,2020-06,ESTIMATED,2020-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,TALISMAN,,Tenecteplase Versus Alteplase in Ischemic Stroke Management (TALISMAN),Phase IIb Study Comparing Tenecteplase to Alteplase in Acute Ischemic Stroke Within 3 to 4.5 Hours From Symptom Onset,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Ohio State University,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,OTHER,,,,,,,2020,0.0
NCT04560686,,2020-06-24,2022-07-01,,2022-07-27,2020-09-21,2020-09-23,ACTUAL,2022-07-27,2022-07-28,ACTUAL,,,,2022-07-27,2022-07-28,ACTUAL,2020-08-05,ACTUAL,2020-08-05,2022-07,2022-07-31,2021-07-01,ACTUAL,2021-07-01,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,,,Bintrafusp Alfa Before Surgery for the Treatment of Untreated Resectable Non-small Cell Lung Cancer,Phase II Study of Neoadjuvant Immune Checkpoint Blockade-Based Therapy With M7824 (Bintrafusp Alpha) for Untreated Resectable Non-Small Cell Lung Cancers,TERMINATED,,PHASE2,2.0,ACTUAL,M.D. Anderson Cancer Center,Two participants were consented; one screen failure. The trial was terminated earlier than planned due to an administrative decision taken by the PI/co-PI in collaboration with the study sponsor based on emerging data made available with the investigational agent being tested in other diseases in the perioperative setting.,1.0,,Per PI Request,,,,,f,t,f,,,,,,,,,,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,OTHER,,,,,,,2021,0.0
NCT04102189,,2019-09-23,2023-03-24,,2023-12-29,2019-09-23,2019-09-25,ACTUAL,2023-03-24,2023-04-18,ACTUAL,,,,2023-12-29,2024-01-02,ACTUAL,2019-10-07,ACTUAL,2019-10-07,2023-12,2023-12-31,2022-03-28,ACTUAL,2022-03-28,2022-03-25,ACTUAL,2022-03-25,,INTERVENTIONAL,,The full analysis set (FAS) included all randomized participants according to the intention-to-treat principle.,A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity,Effect and Safety of Semaglutide 2.4 mg Once Weekly on Weight Management in Adolescents With Overweight or Obesity,COMPLETED,,PHASE3,201.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,t,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,INDUSTRY,,,,,,,2022,1.0
NCT03905889,,2019-04-03,,,2024-06-21,2019-04-03,2019-04-05,ACTUAL,,,,,,,2024-06-21,2024-06-25,ACTUAL,2019-06-05,ACTUAL,2019-06-05,2024-06,2024-06-30,2022-03-08,ACTUAL,2022-03-08,2022-03-08,ACTUAL,2022-03-08,,INTERVENTIONAL,,,A Study of Abemaciclib in Combination With Sunitinib in Metastatic Renal Cell Carcinoma,Targeting PIM1 and CDK4/6 Kinases in Renal Cell Carcinoma (PICKRCC): A Phase Ib Study of Abemaciclib (VerzenioTM) in Combination With Sunitinib in Metastatic Renal Cell Carcinoma,TERMINATED,,PHASE1,3.0,ACTUAL,Brown University,,1.0,,Funding withdrawn,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,OTHER,,,,,,,2022,0.0
NCT01607879,,2012-04-20,2023-07-18,,2023-09-20,2012-05-25,2012-05-30,ESTIMATED,2023-09-20,2023-09-22,ACTUAL,,,,2023-09-20,2023-09-22,ACTUAL,2014-03,,2014-03-31,2023-09,2023-09-30,2021-02-16,ACTUAL,2021-02-16,2018-07,ACTUAL,2018-07-31,,INTERVENTIONAL,,,Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation,Use of β-hydroxy-β-methylbutyrate to Counteract Loss of Muscle Mass and Strength in Older Men With Prostate Cancer Started on Androgen Deprivation Therapy,COMPLETED,,PHASE2,48.0,ACTUAL,Medical College of Wisconsin,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,OTHER,,,,,,,2021,1.0
NCT01843738,,2013-04-19,,,2017-05-22,2013-04-26,2013-05-01,ESTIMATED,,,,,,,2017-05-22,2017-05-24,ACTUAL,2017-06,ESTIMATED,2017-06-30,2017-05,2017-05-31,2022-08,ESTIMATED,2022-08-31,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,,,Radiation Use During Vemurafenib Treatment,Radiation Use During Vemurafenib and Cobimetinib Treatment in Patients With BRAFV600 Mutated Stage IV or Unresectable Stage III Melanoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Utah,,1.0,,Competing Trials,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 19:51:16.731696,2024-10-16 19:51:16.731696,OTHER,,,,,,,2022,0.0
NCT03565991,,2018-05-25,2023-03-22,,2023-08-31,2018-06-11,2018-06-21,ACTUAL,2023-08-04,2023-08-07,ACTUAL,,,,2023-08-31,2023-09-25,ACTUAL,2018-06-18,ACTUAL,2018-06-18,2023-08,2023-08-31,2023-02-03,ACTUAL,2023-02-03,2022-03-28,ACTUAL,2022-03-28,,INTERVENTIONAL,,Baseline analysis population included all enrolled participants who received at least 1 dose of study treatment.,Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors,A PHASE 2 STUDY TO EVALUATE SAFETY AND ANTI-TUMOR ACTIVITY OF AVELUMAB IN COMBINATION WITH TALAZOPARIB IN PATIENTS WITH BRCA OR ATM MUTANT TUMORS JAVELIN BRCA/ATM,TERMINATED,,PHASE2,202.0,ACTUAL,Pfizer,,1.0,,The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the investigational treatments have been moved to a continuation study (NCT05059522),f,,,,,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,INDUSTRY,,,,,,,2023,0.0
NCT04601532,,2020-10-19,2023-11-20,,2024-01-04,2020-10-19,2020-10-23,ACTUAL,2024-01-04,2024-02-01,ACTUAL,,,,2024-01-04,2024-02-01,ACTUAL,2021-06-11,ACTUAL,2021-06-11,2024-01,2024-01-31,2022-12-08,ACTUAL,2022-12-08,2022-12-08,ACTUAL,2022-12-08,,INTERVENTIONAL,,Please see participant flow for details of subject withdraw and lost to follow up.,Superficial Partial-Thickness Burn Study,Randomized Controlled Trial Assessing a Novel Glycopolymer Compound in the Treatment of Superficial Partial-thickness Burns,TERMINATED,,PHASE4,26.0,ACTUAL,University of Pittsburgh,,2.0,,Delayed recruitment,f,,,,f,t,t,,,f,,,,,,NO,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,OTHER,,,,,,,2022,0.0
NCT04393038,,2020-05-18,,,2021-06-28,2020-05-18,2020-05-19,ACTUAL,,,,,,,2021-06-28,2021-06-30,ACTUAL,2020-07-01,ACTUAL,2020-07-01,2021-06,2021-06-30,2021-04-16,ACTUAL,2021-04-16,2021-03-05,ACTUAL,2021-03-05,,INTERVENTIONAL,Mir-Age,,ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19,"A Phase 2/3, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and the Safety of ABX464 in Treating Inflammation and Preventing COVID-19 Associated Acute Respiratory Failure in Patients Aged ≥ 65 and Patients Aged ≥18 With at Least One Additional Risk Factor Who Are Infected With SARS-CoV-2.",TERMINATED,,PHASE2/PHASE3,509.0,ACTUAL,Abivax S.A.,,2.0,,Interim analysis concludes that the study is futile,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,INDUSTRY,,,,,,,2021,0.0
NCT03165292,,2017-05-23,,,2024-05-14,2017-05-23,2017-05-24,ACTUAL,,,,,,,2024-05-14,2024-05-16,ACTUAL,2018-10-01,ACTUAL,2018-10-01,2024-05,2024-05-31,2024-03-28,ACTUAL,2024-03-28,2023-08-28,ACTUAL,2023-08-28,,INTERVENTIONAL,VERITAS,,Evaluation of 2 Intensification Treatment Strategies for Neuroblastoma Patients With a Poor Response to Induction,An International Multicenter Phase II Randomised Trial Evaluating and Comparing Two Intensification Treatment Strategies for Metastatic Neuroblastoma Patients With a Poor Response to Induction Chemotherapy,TERMINATED,,PHASE2,34.0,ACTUAL,"Gustave Roussy, Cancer Campus, Grand Paris",,2.0,,"The Sponsor has been notified of an interruption in the international supply, and there is a possibility that 131I-mlBG would be unavailable to patients randomised to arm A of the trial",f,,,,t,f,f,,,,,,,,,YES,,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,OTHER,,,,,,,2024,0.0
NCT03640650,,2018-05-10,,,2021-09-14,2018-08-20,2018-08-21,ACTUAL,,,,,,,2021-09-14,2021-09-21,ACTUAL,2018-08-15,ACTUAL,2018-08-15,2021-09,2021-09-30,2021-03-16,ACTUAL,2021-03-16,2021-03-16,ACTUAL,2021-03-16,,INTERVENTIONAL,,,Economic Impact of Dropless Therapy Versus Usual Care for Cataract Surgery: A Real-World Study.,Economic Impact of Dropless Therapy Versus Usual Care for Cataract Surgery: A Real-World Study.,TERMINATED,,PHASE4,80.0,ACTUAL,PeriPharm,,2.0,,COVID-19 pandemic leading to uncertainty in the recruitement,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,OTHER,,,,,,,2021,0.0
NCT04090697,,2019-04-04,,,2024-05-22,2019-09-12,2019-09-16,ACTUAL,,,,,,,2024-05-22,2024-05-23,ACTUAL,2019-12-20,ACTUAL,2019-12-20,2023-07,2023-07-31,2023-09-19,ACTUAL,2023-09-19,2023-09-19,ACTUAL,2023-09-19,,INTERVENTIONAL,,,Use of Oxandrolone to Promote Growth in Infants With HLHS,Use of Oxandrolone to Promote Growth in Infants With Hypoplastic Left Heart Syndrome: A Phase I/II Pilot Study,TERMINATED,,PHASE1/PHASE2,34.0,ACTUAL,Carelon Research,,2.0,,FDA withdrawal of Oxandrin NDA and generic ANDAs,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,OTHER,,,,,,,2023,0.0
NCT02595866,,2015-11-03,2024-05-10,,2024-07-16,2015-11-03,2015-11-04,ESTIMATED,2024-06-25,2024-07-16,ACTUAL,,,,2024-07-16,2024-08-09,ACTUAL,2016-04-04,ACTUAL,2016-04-04,2024-05,2024-05-31,2024-03-25,ACTUAL,2024-03-25,2023-10-04,ACTUAL,2023-10-04,,INTERVENTIONAL,,Participants do not have to complete the study in order to be included in the analysis population for the primary outcome measure.,Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retroviral Medications in Patients With HIV and Cancer,Phase I Study of MK-3475 (Pembrolizumab) in Patients With Human Immunodeficiency Virus (HIV) and Relapsed/Refractory or Disseminated Malignant Neoplasm,COMPLETED,,PHASE1,58.0,ACTUAL,National Cancer Institute (NCI),,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,NIH,,,,,,,2024,1.0
NCT02875223,,2016-08-18,,,2024-04-17,2016-08-18,2016-08-23,ESTIMATED,,,,,,,2024-04-17,2024-04-19,ACTUAL,2016-08-31,ACTUAL,2016-08-31,2024-04,2024-04-30,2024-03-25,ACTUAL,2024-03-25,2024-03-25,ACTUAL,2024-03-25,,INTERVENTIONAL,,,A Safety and Efficacy Study of CC-90011 in Participants With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas,"A Phase 1, Open-label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-90011 in Subjects With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas",TERMINATED,,PHASE1,75.0,ACTUAL,Celgene,,2.0,,Business objectives have changed,f,,,,f,,,,,,,,,,,,,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,INDUSTRY,,,,,,,2024,0.0
NCT02442180,,2015-05-02,,,2022-08-04,2015-05-08,2015-05-13,ESTIMATED,,,,,,,2022-08-04,2022-08-08,ACTUAL,2015-07,ACTUAL,2015-07-31,2022-08,2022-08-31,2022-07,ACTUAL,2022-07-31,2022-07,ACTUAL,2022-07-31,,INTERVENTIONAL,GraCiAH,,Efficacy and Safety of G-CSF in Patients With Severe Alcoholic Hepatitis With Null or Partial Response to Steroid,"Efficacy and Safety of Granulocyte-colony Stimulating Factor in Patients With Severe Alcoholic Hepatitis With Null or Partial Response to Steroid: A Randomized, Double-blind, Placebo-controlled, Nationwide Multi-center Study",TERMINATED,,PHASE3,64.0,ACTUAL,Chuncheon Sacred Heart Hospital,,4.0,,failure to recruit eligible patients,f,,,,t,,,,,,,,,,,NO,,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,OTHER,,,,,,,2022,0.0
NCT02756611,,2016-04-26,2020-03-30,,2023-04-07,2016-04-27,2016-04-29,ESTIMATED,2020-04-30,2020-05-04,ACTUAL,,,,2023-04-07,2023-04-10,ACTUAL,2016-06-22,ACTUAL,2016-06-22,2023-04,2023-04-30,2022-03-11,ACTUAL,2022-03-11,2019-04-10,ACTUAL,2019-04-10,,INTERVENTIONAL,VENICE I,,A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL),"Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Efficacy of Venetoclax (ABT 199) in Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL)",COMPLETED,,PHASE3,258.0,ACTUAL,AbbVie,,1.0,,,t,,,,t,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,INDUSTRY,,NCT03123029,AVAILABLE,,,,2022,1.0
NCT05253755,,2021-11-01,2023-09-07,,2023-10-20,2022-02-14,2022-02-24,ACTUAL,2023-10-20,2023-11-08,ACTUAL,,,,2023-10-20,2023-11-08,ACTUAL,2021-10-06,ACTUAL,2021-10-06,2023-10,2023-10-31,2022-09-09,ACTUAL,2022-09-09,2022-09-09,ACTUAL,2022-09-09,,INTERVENTIONAL,,,Study the Safety and Efficacy of DBI-001 Gel Versus Aqueous Gel,"A Randomized, Observer-Blinded, Within Patient Bilateral Comparison to Study the Safety and Efficacy of Daily Application for 4 Weeks of DBI-001 Gel Versus Aqueous Gel in Subjects With Atopic Dermatitis",TERMINATED,,PHASE2,10.0,ACTUAL,"DermBiont, Inc.",,2.0,,Sponsor suspension and not due to safety or site-related matters.,,,,,,t,f,,,,,,,,,,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,INDUSTRY,,,,,,,2022,0.0
NCT04281420,,2020-02-18,,,2024-04-27,2020-02-21,2020-02-24,ACTUAL,,,,,,,2024-04-27,2024-04-30,ACTUAL,2020-04-13,ACTUAL,2020-04-13,2022-07,2022-07-31,2023-10-02,ACTUAL,2023-10-02,2023-10-02,ACTUAL,2023-10-02,,INTERVENTIONAL,TEACH,,A Study of Evaluating Dual Inhibitor of PAK4 and NAMPT ATG-019 in Advanced Solid Tumors or Non-Hodgkin's Lymphoma,"A Phase I Open-Label Study of the Safety and Tolerability of ATG-019, a Dual Inhibitor of PAK4 and NAMPT, in Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma",TERMINATED,,PHASE1,20.0,ACTUAL,Antengene Corporation,,2.0,,Because the sponsor modified the study-product development strategy.,f,,,,f,f,f,,,,,,,,,,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,INDUSTRY,,,,,,,2023,0.0
NCT04525391,,2020-08-14,,,2022-02-08,2020-08-24,2020-08-25,ACTUAL,,,,,,,2022-02-08,2022-02-25,ACTUAL,2020-09-18,ACTUAL,2020-09-18,2022-02,2022-02-28,2022-01-14,ACTUAL,2022-01-14,2022-01-14,ACTUAL,2022-01-14,,INTERVENTIONAL,SUKSES-N5,,AZD2811 and Durvalumab (MEDI4736) Combination Therapy in Relapsed Small Cell Lung Cancer,"Phase II, Single-arm Study of AZD2811 and Durvalumab (MEDI4736) Combination Therapy in Relapsed Small Cell Lung Cancer Subjects [SUKSES-N5]",TERMINATED,,PHASE2,4.0,ACTUAL,Samsung Medical Center,,1.0,,Recommended completion of the study due to SUSAR occurring in other clinical trials conducted with the same drug.,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,OTHER,,,,,,,2022,0.0
NCT02485639,,2015-06-11,2021-12-30,,2023-10-05,2015-06-25,2015-06-30,ESTIMATED,2023-10-05,2023-10-24,ACTUAL,,,,2023-10-05,2023-10-24,ACTUAL,2015-12-23,ACTUAL,2015-12-23,2021-03,2021-03-31,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,,Analysis of Bone Marrow and Blood B Cell Immune Responses to Influenza Vaccination,Analysis of Bone Marrow and Blood B Cell Immune Responses to Influenza Vaccination,TERMINATED,,PHASE4,27.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),"Due to the COVID-19 pandemic, all non-essential research was halted at our site (mid-March 2020). New enrollments and follow-up visits were halted, impacting participants' follow-up visits. One Day 28 visit was halted, three Day 90 visits were halted. Seven Day 365 visits were halted. We requested an expansion of the visit windows, however, enrollment for this study ended on March 31, 2020, before research activities could resume at Emory.",1.0,,Study was terminated due to CoronaVIrus Disease of 2019 (COVID-19) pandemic.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,NIH,,,,,,,2020,0.0
NCT04672980,,2020-12-08,,,2022-12-06,2020-12-16,2020-12-17,ACTUAL,,,,,,,2022-12-06,2022-12-08,ACTUAL,2021-04-08,ACTUAL,2021-04-08,2022-12,2022-12-31,2022-11-30,ACTUAL,2022-11-30,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,,,RTX-321 Monotherapy in Patients With HPV 16+ Tumors,A Phase 1 Study of RTX-321 for the Treatment of Patients With Advanced Malignancies Associated With Human Papillomavirus-16 Infection,TERMINATED,,PHASE1,9.0,ACTUAL,Rubius Therapeutics,,2.0,,"The Sponsor terminated study after dosing 3 dose groups (9 pts) and closed trial on 11/30/22. RTX-321 was well-tolerated with no DLTs, no related deaths, SAEs or Gr. 3/4 AEs and cleared from circulation rapidly (w/in 10 min).",f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 23:01:29.34576,2024-10-14 23:01:29.34576,INDUSTRY,,,,,,,2022,0.0
NCT03983720,,2019-06-07,,,2023-10-31,2019-06-11,2019-06-12,ACTUAL,,,,,,,2023-10-31,2023-11-02,ACTUAL,2020-01-21,ACTUAL,2020-01-21,2023-10,2023-10-31,2021-07-31,ACTUAL,2021-07-31,2021-06-16,ACTUAL,2021-06-16,,INTERVENTIONAL,FatSEP,,Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?,Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?,TERMINATED,,PHASE2,67.0,ACTUAL,Centre Hospitalier Universitaire de Saint Etienne,,3.0,,low inclusion rates,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 23:07:12.994837,2024-10-14 23:07:12.994837,OTHER,,,,,,,2021,0.0
NCT04775680,,2021-02-16,,,2023-04-20,2021-02-25,2021-03-01,ACTUAL,,,,,,,2023-04-20,2023-04-24,ACTUAL,2021-03-11,ACTUAL,2021-03-11,2023-04,2023-04-30,2023-02-09,ACTUAL,2023-02-09,2023-02-09,ACTUAL,2023-02-09,,INTERVENTIONAL,,,Study of ADG106 In Combination With PD-1 Antibody In Advanced or Metastatic Solid Tumors and/or Non Hodgkin Lymphoma,"A Multicenter, Open-Label, Phase Ib/II Study of ADG106 in Combination With PD-1 Antibody in Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma",TERMINATED,,PHASE1/PHASE2,25.0,ACTUAL,Adagene Inc,,3.0,,The safety of ADG106 combined with triprilimab has been fully understood.The overall clinical benefit of enrolled subjects was limited and further development of ADG106 was reconsidered.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,INDUSTRY,,,,,,,2023,0.0
NCT05926440,,2023-06-08,,,2023-08-23,2023-06-21,2023-07-03,ACTUAL,,,,,,,2023-08-23,2023-08-25,ACTUAL,2023-08-17,ACTUAL,2023-08-17,2023-08,2023-08-31,2023-08-17,ACTUAL,2023-08-17,2023-08-17,ACTUAL,2023-08-17,,INTERVENTIONAL,,,Immunogenicity and Safety Study of SCB-2023 Vaccine as a Booster in Adults,"Phase 3, Multi-center, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of SCB-2023 Vaccine Administered as a Booster Dose to Adults Who Previously Received COVID-19 Vaccine",WITHDRAWN,,PHASE3,0.0,ACTUAL,Clover Biopharmaceuticals AUS Pty Ltd,,2.0,,we has selected a new candidate vaccine which is monovalent.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,INDUSTRY,,,,,,,2023,0.0
NCT04577001,,2020-09-30,2024-03-19,,2024-04-18,2020-09-30,2020-10-06,ACTUAL,2024-04-18,2024-05-14,ACTUAL,,,,2024-04-18,2024-05-14,ACTUAL,2021-02-18,ACTUAL,2021-02-18,2024-04,2024-04-30,2021-03-26,ACTUAL,2021-03-26,2021-03-26,ACTUAL,2021-03-26,,INTERVENTIONAL,,Study terminated due to low recruitment numbers. No subjects were enrolled in the Letrozole group.,Letrozole in Patients With Hepatopulmonary Syndrome,Letrozole in Patients With Hepatopulmonary Syndrome: A Double-Blind Randomized Clinical Trial,TERMINATED,,PHASE2,1.0,ACTUAL,Mayo Clinic,Terminated study due to low recruitment numbers.,2.0,,Low Recruitment Numbers,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,OTHER,,,,,,,2021,0.0
NCT04037891,,2019-02-13,,,2021-03-16,2019-07-29,2019-07-30,ACTUAL,,,,,,,2021-03-16,2021-03-18,ACTUAL,2019-02-20,ACTUAL,2019-02-20,2021-03,2021-03-31,2020-12-15,ACTUAL,2020-12-15,2020-12-15,ACTUAL,2020-12-15,,INTERVENTIONAL,,,Topical rVA576 for Treatment of Atopic Keratoconjunctivitis,Topical rVA576 for Treatment of Atopic Keratoconjunctivitis: a Randomised Placebo-controlled Double Masked Parallel Trial (TRACKER),TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,AKARI Therapeutics,,2.0,,"The trial has terminated early due to the disruptions caused by the ongoing COVID-19 pandemic. The decision was not related to any efficacy, safety or clinical concerns regarding rVA576/Coversin.",f,,,,t,f,f,,,,,,,,,,,2024-10-14 23:07:12.994837,2024-10-14 23:07:12.994837,INDUSTRY,,,,,,,2020,0.0
NCT02972593,,2016-11-17,2023-06-06,,2023-06-28,2016-11-21,2016-11-23,ESTIMATED,2023-06-28,2023-06-29,ACTUAL,,,,2023-06-28,2023-06-29,ACTUAL,2014-03,ACTUAL,2014-03-31,2023-06,2023-06-30,2022-06-24,ACTUAL,2022-06-24,2022-06-24,ACTUAL,2022-06-24,,INTERVENTIONAL,ORACL,"One hundred patients were enrolled and randomized; however, it was noted the day after enrollment for a patient in the liberal group that the patient should not have been enrolled due to a creatinine higher than allowed by the exclusion criteria. The patient was immediately removed from the study and not included in the statistical analysis.",ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion,ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion,COMPLETED,,PHASE4,161.0,ACTUAL,Indiana University,Significant loss to follow up; Significant resistance by multiple providers at each site to allow conservative treatment algorithm (as most felt liberal was standard of care); Slow enrollment; No funding,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,OTHER,,,,,,,2022,1.0
NCT03278626,,2017-08-31,2022-02-09,,2022-03-02,2017-09-08,2017-09-11,ACTUAL,2022-03-02,2022-03-28,ACTUAL,,,,2022-03-02,2022-03-28,ACTUAL,2017-06-27,ACTUAL,2017-06-27,2022-03,2022-03-31,2021-05-31,ACTUAL,2021-05-31,2019-11-07,ACTUAL,2019-11-07,,INTERVENTIONAL,,"6 subjects enrolled in Phase 1, and 6 subjects enrolled in Phase 2",Immune Checkpoint Therapy With Nivolumab Esophageal Squamous Cell Carcinoma,A Phase I/II Open Label Multi Center Study of Immune Checkpoint Therapy With Nivolumab for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma,TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,NYU Langone Health,,1.0,,The study was stopped earlier than anticipated due to slow accrual,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,OTHER,,,,,,,2021,0.0
NCT04050293,,2019-08-02,,,2024-08-07,2019-08-06,2019-08-08,ACTUAL,,,,,,,2024-08-07,2024-08-09,ACTUAL,2020-07-14,ACTUAL,2020-07-14,2024-08,2024-08-31,2024-05-29,ACTUAL,2024-05-29,2024-05-29,ACTUAL,2024-05-29,,INTERVENTIONAL,,,Therapy for Migraine Prevention in Children 6-11 Years of Age,"A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of SPN-538 as a Therapy for the Prevention of Migraine in Subjects Ages 6-11 Years",TERMINATED,,PHASE4,26.0,ACTUAL,"Supernus Pharmaceuticals, Inc.",,2.0,,Difficulty in recruitment,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:19:35.527909,2024-10-15 13:19:35.527909,INDUSTRY,,,,,,,2024,0.0
NCT03953326,,2019-05-13,,,2021-01-28,2019-05-14,2019-05-16,ACTUAL,,,,,,,2021-01-28,2021-02-02,ACTUAL,2019-04-23,ACTUAL,2019-04-23,2021-01,2021-01-31,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,HeartPhone Cancer Survivors Trial 2019,Digital Intervention to Promote Physical Activity and Improve Cardiovascular Health Among Cancer Survivors,TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,Penn State University,,1.0,,Futility in recruitment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,OTHER,,,,,,,2020,0.0
NCT03932318,,2019-04-17,,,2023-07-19,2019-04-29,2019-04-30,ACTUAL,,,,,,,2023-07-19,2023-07-20,ACTUAL,2023-03,ESTIMATED,2023-03-31,2023-07,2023-07-31,2024-09,ESTIMATED,2024-09-30,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,"Venetoclax, Azacitidine, and Lintuzumab-Ac225 in AML Patients",A Phase I/II Study of Venetoclax and Azacitidine and Lintuzumab-Ac225 in Patients With Refractory or Relapsed AML,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Actinium Pharmaceuticals,,1.0,,study postponed,f,,,,,t,f,,,,,,,,,,,2024-10-14 23:07:12.994837,2024-10-14 23:07:12.994837,INDUSTRY,,,,,,,2024,0.0
NCT05457842,,2022-07-11,2024-03-19,,2024-04-30,2022-07-11,2022-07-14,ACTUAL,2024-04-30,2024-05-01,ACTUAL,,,,2024-04-30,2024-05-01,ACTUAL,2022-08-10,ACTUAL,2022-08-10,2024-04,2024-04-30,2022-09-20,ACTUAL,2022-09-20,2022-09-02,ACTUAL,2022-09-02,,INTERVENTIONAL,,Full analysis set (FAS): Participant enrolled and received study Investigational product (IP).,A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery,"A Phase 2 Open-label, Dose-finding Study to Determine the Optimal Dose for Lymph Node Visualization Using ASP5354 in Participants With Breast Cancer or Melanoma Undergoing Sentinel Lymph Node Biopsy",TERMINATED,,PHASE2,1.0,ACTUAL,Astellas Pharma Inc,,1.0,,Company's strategic decision,f,,,,f,t,f,,,,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://www.clinicalstudydatarequest.com,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-14 23:07:12.994837,2024-10-14 23:07:12.994837,INDUSTRY,,,,,,,2022,0.0
NCT02780583,,2016-05-11,,,2024-07-30,2016-05-18,2016-05-23,ESTIMATED,,,,,,,2024-07-30,2024-08-01,ACTUAL,2016-05-15,ACTUAL,2016-05-15,2024-07,2024-07-31,2024-04-30,ACTUAL,2024-04-30,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,MAS,,Treatment of Macrophage Activation Syndrome (MAS) With Anakinra,Randomized Placebo Controlled Trial of Subcutaneous rhIL-1A (Anakinra) in the Management of Hospitalized Pediatric and Adult Patients With Macrophage Activation Syndrome,TERMINATED,,PHASE1,9.0,ACTUAL,University of Alabama at Birmingham,,2.0,,"no further funding to continue, investigator relocated, no replacement found to continue",f,,,,t,,,,,,,,Dec 31 2020,request to investigator,,YES,Nurse Study Coordinators will gather and enter data,2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,OTHER,,,,,,,2024,0.0
NCT05179057,,2021-12-17,2024-04-15,,2024-04-15,2022-01-04,2022-01-05,ACTUAL,2024-04-15,2024-05-08,ACTUAL,,,,2024-04-15,2024-05-08,ACTUAL,2022-04-26,ACTUAL,2022-04-26,2024-04,2024-04-30,2024-01-31,ACTUAL,2024-01-31,2024-01-31,ACTUAL,2024-01-31,,INTERVENTIONAL,,,Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation,"Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, With Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation",TERMINATED,,PHASE3,57.0,ACTUAL,AlloVir,"The study was discontinued following a pre-planned DSMB futility analysis concluding that the study was unlikely to meet its primary endpoint, no safety concerns were identified.",2.0,,Study discontinued as DSMB determined it was futile. No safety concerns were noted.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,INDUSTRY,,,,,,,2024,0.0
NCT02543944,,2015-08-25,2022-05-25,,2022-07-27,2015-09-03,2015-09-07,ESTIMATED,2022-07-27,2022-07-28,ACTUAL,,,,2022-07-27,2022-07-28,ACTUAL,2016-02,ACTUAL,2016-02-29,2022-05,2022-05-31,2021-05-31,ACTUAL,2021-05-31,2021-05-25,ACTUAL,2021-05-25,,INTERVENTIONAL,GBN,,Improving Treatment Outcomes for Prescription Opioid Dependence,Improving Treatment Outcomes for Prescription Opioid Dependence,COMPLETED,,PHASE2/PHASE3,117.0,ACTUAL,University of Arkansas,,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,OTHER,,,,,,,2021,1.0
NCT02497638,,2015-06-19,,,2021-04-16,2015-07-10,2015-07-14,ESTIMATED,,,,,,,2021-04-16,2021-04-19,ACTUAL,2021-12,ESTIMATED,2021-12-31,2021-04,2021-04-30,2022-12,ESTIMATED,2022-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,LIGAND,,LIpitor and biGuanide to Androgen Delay Trial,"A Randomized, Double Blind, Trial of Metformin and Atorvastatin in Delaying Androgen Deprivation Therapy Among Men With Rising PSA Following Radical Prostatectomy or Radiotherapy: The LIGAND (LIpitor and biGuanide to Androgen Delay) Trial",WITHDRAWN,,PHASE2,0.0,ACTUAL,"University Health Network, Toronto",,2.0,,Drug intervention no longer relevant for the proposed population,f,,,,t,f,f,,,,,,,,,,,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,OTHER,,,,,,,2022,0.0
NCT05559905,,2022-09-26,2024-04-16,,2024-05-17,2022-09-26,2022-09-29,ACTUAL,2024-05-17,2024-05-20,ACTUAL,,,,2024-05-17,2024-05-20,ACTUAL,2022-11-02,ACTUAL,2022-11-02,2024-05,2024-05-31,2023-06-08,ACTUAL,2023-06-08,2023-04-18,ACTUAL,2023-04-18,,INTERVENTIONAL,,,Respiratory Syncytial Virus (RSV) Human Challenge Study of Molnupiravir in Healthy Participants (MK-4482-017),"A Phase 2a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-4482 in Healthy Participants Inoculated With Experimental Respiratory Syncytial Virus",COMPLETED,,PHASE2,116.0,ACTUAL,Merck Sharp & Dohme LLC,,3.0,,,f,,,,f,t,f,,,t,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-14 23:07:12.994837,2024-10-14 23:07:12.994837,INDUSTRY,,,,,,,2023,1.0
NCT04193904,,2019-11-12,,,2023-06-01,2019-12-06,2019-12-10,ACTUAL,,,,,,,2023-06-01,2023-06-02,ACTUAL,2019-12-20,ACTUAL,2019-12-20,2023-06,2023-06-30,2023-05-08,ACTUAL,2023-05-08,2023-05-08,ACTUAL,2023-05-08,,INTERVENTIONAL,,,A Study of Live Biotherapeutic Product MRx0518 With Hypofractionated Radiation Therapy in Resectable Pancreatic Cancer,A Safety and Preliminary Efficacy Study of the Oral Live Biotherapeutic MRx0518 With Hypofractionated Preoperative Radiation for Resectable Pancreatic Cancer,TERMINATED,,PHASE1,13.0,ACTUAL,4D pharma plc,,1.0,,Sponsor insolvency,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 23:07:12.994837,2024-10-14 23:07:12.994837,INDUSTRY,,,,,,,2023,0.0
NCT02686177,,2016-02-15,,,2021-06-14,2016-02-18,2016-02-19,ESTIMATED,,,,,,,2021-06-14,2021-06-15,ACTUAL,2016-05-18,ACTUAL,2016-05-18,2021-06,2021-06-30,2021-05-28,ACTUAL,2021-05-28,2017-08-08,ACTUAL,2017-08-08,,INTERVENTIONAL,ANGIOSAFE 1,,Effect of GLP-1 on Angiogenesis,"Effect of GLP-1 on Angiogenesis, Angiosafe Type 2 Diabetes Study 1",COMPLETED,,PHASE4,50.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,OTHER,,,,,,,2021,1.0
NCT03718650,,2018-10-23,,,2021-02-03,2018-10-23,2018-10-24,ACTUAL,,,,,,,2021-02-03,2021-02-08,ACTUAL,2021-04-01,ESTIMATED,2021-04-01,2021-02,2021-02-28,2023-04-01,ESTIMATED,2023-04-01,2022-04-01,ESTIMATED,2022-04-01,,INTERVENTIONAL,,,Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer,Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer: Establishing the Radiomic/Pathologic Foundation of Heterogeneity,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,1.0,,Lack of funding,,,,,f,t,f,,,,,,,,,,,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,OTHER,,,,,,,2023,0.0
NCT01094977,,2010-03-23,,,2019-07-11,2010-03-26,2010-03-29,ESTIMATED,,,,,,,2019-07-11,2019-07-15,ACTUAL,2010-01,ACTUAL,2010-01-31,2019-07,2019-07-31,2020-01,ESTIMATED,2020-01-31,2020-01,ESTIMATED,2020-01-31,,INTERVENTIONAL,,,Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid,Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid Undergoing Craniosynostosis Reconstruction: A Randomized Placebo-Controlled Double Blind Study of Low and High Dose Therapy,SUSPENDED,,PHASE3,90.0,ESTIMATED,The Hospital for Sick Children,,3.0,,Inadequate funding,f,,,,f,,,,,,,,,,,,,2024-10-14 23:07:12.994837,2024-10-14 23:07:12.994837,OTHER,,,,,,,2020,0.0
NCT02152943,,2014-05-29,,,2020-12-16,2014-05-29,2014-06-02,ESTIMATED,,,,,,,2020-12-16,2020-12-19,ACTUAL,2014-07-17,ACTUAL,2014-07-17,2020-12,2020-12-31,2020-12-14,ACTUAL,2020-12-14,2020-12-14,ACTUAL,2020-12-14,,INTERVENTIONAL,,,"Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients","Combination Treatment With Everolimus, Letrozole and Trastuzumab in Hormone Receptor and HER2/Neu-Positive Patients With Advanced Metastatic Breast Cancer and Other Solid Tumors: Evaluating Synergy and Overcoming Resistance",COMPLETED,,PHASE1,37.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,OTHER,,,,,,,2020,1.0
NCT03320070,,2017-10-20,2022-11-14,,2023-02-24,2017-10-20,2017-10-25,ACTUAL,2023-02-24,2023-02-27,ACTUAL,,,,2023-02-24,2023-02-27,ACTUAL,2018-02-21,ACTUAL,2018-02-21,2023-02,2023-02-28,2021-11-15,ACTUAL,2021-11-15,2021-11-15,ACTUAL,2021-11-15,,INTERVENTIONAL,PULSAR,The safety population included all randomized participants who received at least 1 dose of IMP.,Acthar Gel in Participants With Pulmonary Sarcoidosis,"A Multicenter, Randomized, Double Blind, Placebo Controlled Exploratory Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Pulmonary Sarcoidosis",COMPLETED,,PHASE4,55.0,ACTUAL,Mallinckrodt,,2.0,,,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,INDUSTRY,,,,,,,2021,1.0
NCT02750254,,2016-04-18,,,2020-10-16,2016-04-20,2016-04-25,ESTIMATED,,,,,,,2020-10-16,2020-10-20,ACTUAL,2016-06-27,ACTUAL,2016-06-27,2020-10,2020-10-31,2020-10-14,ACTUAL,2020-10-14,2017-05-24,ACTUAL,2017-05-24,,INTERVENTIONAL,,,Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation,A Phase I/II Study of Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation,TERMINATED,,PHASE1,5.0,ACTUAL,Washington University School of Medicine,,1.0,,Toxicity. Only enrolled patients in phase I portion of trial.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,OTHER,,,,,,,2020,0.0
NCT04301778,,2020-03-06,2023-03-06,,2024-02-14,2020-03-06,2020-03-10,ACTUAL,2023-03-06,2023-03-31,ACTUAL,,,,2024-02-14,2024-02-20,ACTUAL,2021-08-24,ACTUAL,2021-08-24,2024-02,2024-02-29,2024-02-06,ACTUAL,2024-02-06,2022-11-04,ACTUAL,2022-11-04,,INTERVENTIONAL,,,Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma,A Phase II Study of Durvalumab (MEDI4736) in Combination With a CSF-1R Inhibitor (SNDX-6532) Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma.,COMPLETED,,PHASE2,5.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,OTHER,,,,,,,2024,1.0
NCT04134442,,2019-10-02,,,2022-06-30,2019-10-17,2019-10-22,ACTUAL,,,,,,,2022-06-30,2022-07-06,ACTUAL,2019-12-09,ACTUAL,2019-12-09,2022-06,2022-06-30,2021-09-23,ACTUAL,2021-09-23,2021-09-23,ACTUAL,2021-09-23,,INTERVENTIONAL,,,Improving Pain Management After Total Shoulder Replacement Using Bupivacaine Liposome,Improving Pain Management After Total Shoulder Replacement Using Bupivacaine Liposome,WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of Massachusetts, Worcester",,2.0,,A new large meta-analysis was published. The results showed the likelihood that liposomal bupivacaine and nerve blocks no longer offer significant contribution. Decision was made to terminate the study.,f,,,,,t,f,,,t,,,,,,,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,OTHER,,,,,,,2021,0.0
NCT02579863,,2015-10-16,2019-06-07,,2021-06-29,2015-10-16,2015-10-20,ESTIMATED,2019-08-29,2019-09-17,ACTUAL,,,,2021-06-29,2021-07-20,ACTUAL,2015-10-19,ACTUAL,2015-10-19,2021-06,2021-06-30,2020-07-13,ACTUAL,2020-07-13,2018-07-09,ACTUAL,2018-07-09,,INTERVENTIONAL,,The analysis population included all randomized participants.,Study of Lenalidomide and Dexamethasone With or Without Pembrolizumab (MK-3475) in Participants With Newly Diagnosed Treatment Naive Multiple Myeloma (MK-3475-185/KEYNOTE-185),A Phase III Study of Lenalidomide and Low-Dose Dexamethasone With or Without Pembrolizumab (MK3475) in Newly Diagnosed and Treatment Naïve Multiple Myeloma (KEYNOTE 185).,TERMINATED,,PHASE3,310.0,ACTUAL,Merck Sharp & Dohme LLC,The MK-3475-185 study was stopped/terminated early. Endpoint statistics may be biased due to the incomplete treatment and follow-up of participants after study termination,2.0,,The study was terminated early due to business reasons,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,INDUSTRY,,,,,,,2020,0.0
NCT05535023,,2022-09-04,,,2023-09-11,2022-09-07,2022-09-10,ACTUAL,,,,,,,2023-09-11,2023-09-13,ACTUAL,2022-08-24,ACTUAL,2022-08-24,2023-09,2023-09-30,2023-07-25,ACTUAL,2023-07-25,2023-07-25,ACTUAL,2023-07-25,,INTERVENTIONAL,,,Phase 2 Study of Neoadjuvant SAR444245 Plus Cemiplimab in HPV Related Oropharynx Squamous Cell Carcinoma,Phase 2 Study of Neoadjuvant SAR444245 Plus Cemiplimab in HPV Related Oropharynx,WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,PI Request,,,,,t,t,f,,,,,,,,,,,2024-10-14 23:07:12.994837,2024-10-14 23:07:12.994837,OTHER,,,,,,,2023,0.0
NCT03989349,,2019-06-14,2024-06-21,2023-09-19,2024-08-09,2019-06-14,2019-06-18,ACTUAL,2024-08-09,2024-08-14,ACTUAL,,2024-08-14,ACTUAL,2024-08-09,2024-08-14,ACTUAL,2019-06-30,ACTUAL,2019-06-30,2024-08,2024-08-31,2022-09-26,ACTUAL,2022-09-26,2022-02-23,ACTUAL,2022-02-23,,INTERVENTIONAL,,The ITT population consisted of all randomized participants.,Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis,"A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis",COMPLETED,,PHASE3,787.0,ACTUAL,Galderma R&D,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:07:12.994837,2024-10-14 23:07:12.994837,INDUSTRY,,,,,,,2022,1.0
NCT05513391,,2022-08-22,2024-07-01,,2024-07-01,2022-08-23,2022-08-24,ACTUAL,2024-07-01,2024-07-24,ACTUAL,,,,2024-07-01,2024-07-24,ACTUAL,2022-11-10,ACTUAL,2022-11-10,2024-06,2024-06-30,2023-10-03,ACTUAL,2023-10-03,2023-10-03,ACTUAL,2023-10-03,,INTERVENTIONAL,,Analysis was performed on all participants randomized by study interactive response technology to one of the study groups.,Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years,Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine Compared With Egg-Based Standard-Dose Quadrivalent Influenza Vaccine in Children 3 to 8 Years of Age.,TERMINATED,,PHASE3,366.0,ACTUAL,Sanofi,Sponsor decision to prematurely stop the study. This decision was made without any safety concerns.,2.0,,Sponsor decision to prematurely stop the study. This decision was made without any safety concerns.,f,,,,f,t,f,,,f,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,INDUSTRY,,,,,,,2023,0.0
NCT03389412,,2017-12-27,,,2023-07-31,2017-12-27,2018-01-03,ACTUAL,,,,,,,2023-07-31,2023-08-02,ACTUAL,2017-10-01,ACTUAL,2017-10-01,2023-07,2023-07-31,2023-01-03,ACTUAL,2023-01-03,2023-01-03,ACTUAL,2023-01-03,,INTERVENTIONAL,DRYCHILD,,The Effect of Selecting Treatment With Desmopressin or Alarm to Children With Enuresis Based on Home Recordings.,The Effect of Clinical Characterization of Children With Monosymptomatic Nocturnal Enuresis on the Efficacy of Desmopressin and Alarm Therapy.,COMPLETED,,PHASE4,324.0,ACTUAL,University of Aarhus,,6.0,,,f,,,,f,f,f,,,f,,,,,,YES,,2024-10-14 23:07:12.994837,2024-10-14 23:07:12.994837,OTHER,,,,,,,2023,1.0
NCT03462641,,2018-03-06,2022-06-04,,2022-09-15,2018-03-06,2018-03-12,ACTUAL,2022-06-04,2022-06-29,ACTUAL,,,,2022-09-15,2022-09-27,ACTUAL,2018-03-09,ACTUAL,2018-03-09,2022-09,2022-09-30,2021-06-04,ACTUAL,2021-06-04,2021-06-04,ACTUAL,2021-06-04,,INTERVENTIONAL,,This is a per protocol analysis. Only the 28 participants that actually completed the entire study are included.,Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil Arm,Modulation of GABA-A Receptors and Axial Motor Impairments in Parkinson Disease-Flumazenil Arm,COMPLETED,,PHASE1/PHASE2,36.0,ACTUAL,University of Michigan,"Our participants were predominantly male, which is often the case with Parkinson's disease (PD) patient population since PD is known to affect males at a greater rate. This means that our findings may not generalize as well to population of female PD patients.",2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:07:12.994837,2024-10-14 23:07:12.994837,OTHER,,,,,,,2021,1.0
NCT01495598,,2011-12-16,2022-08-08,,2022-10-05,2011-12-16,2011-12-20,ESTIMATED,2022-10-05,2022-11-01,ACTUAL,,,,2022-10-05,2022-11-01,ACTUAL,2012-01-10,ACTUAL,2012-01-10,2022-10,2022-10-31,2022-05-17,ACTUAL,2022-05-17,2022-05-17,ACTUAL,2022-05-17,,INTERVENTIONAL,,,Pomalidomide for Kaposi Sarcoma in People With or Without HIV,"A Phase I/II Study of the Safety, Pharmacokinetics and Efficacy of Pomalidomide (CC-4047) in the Treatment of Kaposi Sarcoma in Individuals With or Without HIV",COMPLETED,,PHASE1/PHASE2,28.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,,f,,,,f,t,f,,,,,,Clinical data available during the study and indefinitely. All collected IPD will be available after primary analysis have been published.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).,,YES,All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.~All collected IPD will be shared with collaborators under the terms of collaborative agreements.,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,NIH,,,,,,,2022,1.0
NCT04356677,,2020-04-20,,,2021-06-17,2020-04-21,2020-04-22,ACTUAL,,,,,,,2021-06-17,2021-06-22,ACTUAL,2021-05,ESTIMATED,2021-05-31,2021-06,2021-06-30,2021-08,ESTIMATED,2021-08-31,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,,,Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19,"An Open-Label Study to Evaluate the Safety and Efficacy of VIRAZOLE® (RIBAVIRIN FOR INHALATION SOLUTION, USP) in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Bausch Health Americas, Inc.",,2.0,,"Due to pandemic status changing in Canada prior to investigative sites being initiated for participation, and that concurrent participant recruitment in the global study BHC-RIB-5401-GL will achieve target enrollment across all countries.",f,,,,f,f,f,,,f,,,,,,,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,INDUSTRY,,,,,,,2021,0.0
NCT02564380,,2015-09-10,,,2021-12-14,2015-09-29,2015-09-30,ESTIMATED,,,,,,,2021-12-14,2022-01-04,ACTUAL,2016-01-19,ACTUAL,2016-01-19,2021-12,2021-12-31,2020-11-23,ACTUAL,2020-11-23,2020-05-23,ACTUAL,2020-05-23,,INTERVENTIONAL,PRIMUS,,Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients With Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC),"A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients With Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC)",TERMINATED,,PHASE2,41.0,ACTUAL,AIO-Studien-gGmbH,,2.0,,Since trial start in Jan. 2016 only 41 patients could be recruited until planned date of end of follow up period. Under consideration of this fact the recruitment of the planned 130 patients was not possible within a reasonable recruitment period.,f,,,,t,,,,,,,,,,,,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,OTHER,,,,,,,2020,0.0
NCT04623255,,2020-06-11,2023-11-24,,2024-05-10,2020-11-09,2020-11-10,ACTUAL,2024-05-10,2024-06-07,ACTUAL,,,,2024-05-10,2024-06-07,ACTUAL,2020-10-16,ACTUAL,2020-10-16,2024-05,2024-05-31,2022-01-31,ACTUAL,2022-01-31,2022-01-31,ACTUAL,2022-01-31,,INTERVENTIONAL,COVIPLEX,Note: 23 patients with severe COVID-19 were randomised. One patient withdrew from the study 1 day after randomisation and their data has been excluded from the analysis. 11 were randomised to the treatment group receiving at least one course of Plasma Exchange (PEX).11 were assigned to the control group receiving only standard of care treatment (SOC). There were no follow-up data for a further two participants (1 from each arm) and hence they were omitted from this analysis.,Study of Plasma Exchange in Severe COVID-19,A Randomised Controlled Trial of Plasma Exchange With Standard of Care Compared to Standard of Care Alone in the Treatment of Severe COVID-19 Infection (COVIPLEX),COMPLETED,,PHASE2,23.0,ACTUAL,"University College, London",,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,OTHER,,,,,,,2022,1.0
NCT03483363,,2018-03-23,2024-04-15,,2024-04-15,2018-03-23,2018-03-30,ACTUAL,2024-04-15,2024-05-08,ACTUAL,,,,2024-04-15,2024-05-08,ACTUAL,2018-10-09,ACTUAL,2018-10-09,2024-04,2024-04-30,2022-01-02,ACTUAL,2022-01-02,2022-01-02,ACTUAL,2022-01-02,,INTERVENTIONAL,,,Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical Wounds,Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical Wounds,TERMINATED,,PHASE4,39.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,recruitment issues,f,,,,,t,f,,,f,,,,,,,,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,OTHER,,,,,,,2022,0.0
NCT03446807,,2018-02-20,,,2022-02-14,2018-02-23,2018-02-27,ACTUAL,,,,,,,2022-02-14,2022-03-02,ACTUAL,2021-12,ESTIMATED,2021-12-31,2022-02,2022-02-28,2023-07-01,ESTIMATED,2023-07-01,2023-07-01,ESTIMATED,2023-07-01,,INTERVENTIONAL,,,Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism,Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism,WITHDRAWN,,PHASE2,0.0,ACTUAL,Loma Linda University,,2.0,,Sponsor Decision to terminate,f,,,,t,t,f,,,,,,The data will be available to Lundbeck from the start of the study through it's completion.,"This material will be provided to Lundbeck in person, not electronically.",,YES,"Lundbeck is funding this study and will be providing the study drug. If Lundbeck requests, they will be provided with protocol, statistical analysis plan, clinical study report, and any other study data they request. All adverse events will be reported to Lundbeck.",2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,OTHER,,,,,,,2023,0.0
NCT03151304,,2017-05-05,2021-12-15,,2022-02-04,2017-05-10,2017-05-12,ACTUAL,2022-02-04,2022-03-02,ACTUAL,,,,2022-02-04,2022-03-02,ACTUAL,2017-06-01,ACTUAL,2017-06-01,2022-02,2022-02-28,2020-12-01,ACTUAL,2020-12-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,,,A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes,"A Two-Stage, Open-Label Phase 2 Study of Pracinostat and Azacitidine in Patients With IPSS-R High and Very High Risk Myelodysplastic Syndromes Previously Untreated With Hypomethylating Agents",TERMINATED,,PHASE2,64.0,ACTUAL,Helsinn Healthcare SA,,1.0,,"Sponsor's decision as at the completion of the primary analysis, the data were considered mature",f,,,,,t,f,,,,,,,,,,,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,INDUSTRY,,,,,,,2020,0.0
NCT05435846,,2022-06-22,,,2024-06-07,2022-06-22,2022-06-28,ACTUAL,,,,,,,2024-06-07,2024-06-11,ACTUAL,2022-08-10,ACTUAL,2022-08-10,2024-06,2024-06-30,2024-05-31,ACTUAL,2024-05-31,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,,,Capmatinib Plus Trametinib for the Treatment of Metastatic Non-small Cell Lung Cancer With MET Exon 14 Skipping Mutation,A Multicenter Phase I/Ib Study of Capmatinib Plus Trametinib in Patients With Metastatic MET Exon 14 Skipping Mutation Positive NSCLC,TERMINATED,,PHASE1,3.0,ACTUAL,"University of California, San Francisco",,2.0,,slow accrual,,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,OTHER,,,,,,,2024,0.0
NCT04637555,,2020-11-04,,,2021-11-16,2020-11-17,2020-11-19,ACTUAL,,,,,,,2021-11-16,2021-11-26,ACTUAL,2021-05-26,ESTIMATED,2021-05-26,2021-11,2021-11-30,2023-06-01,ESTIMATED,2023-06-01,2023-06-01,ESTIMATED,2023-06-01,,INTERVENTIONAL,,,Open-label Extension Study for CLCZ696G2301 (PARADISE-MI),A Multicenter Study to Evaluate the Long-term Safety and Tolerability of Open-label LCZ696 in Patients With Acute Myocardial Infarction Who Previously Participated in CLCZ696G2301 (PARADISE-MI),WITHDRAWN,,PHASE3,0.0,ACTUAL,Novartis,,1.0,,CLCZ696G2301E1 extension study did not start as the core study (CLCZ696G2301) did not meet the primary endpoint.,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,INDUSTRY,,,,,,,2023,0.0
NCT04898348,,2021-05-13,,,2023-07-31,2021-05-18,2021-05-24,ACTUAL,,,,,,,2023-07-31,2023-08-02,ACTUAL,2022-01-14,ACTUAL,2022-01-14,2022-09,2022-09-30,2023-07-28,ACTUAL,2023-07-28,2023-07-28,ACTUAL,2023-07-28,,INTERVENTIONAL,,,A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis,"A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis",WITHDRAWN,,PHASE2,0.0,ACTUAL,KoBioLabs,,2.0,,No patients recruited,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-14 23:07:12.994837,2024-10-14 23:07:12.994837,INDUSTRY,,,,,,,2023,0.0
NCT04359862,,2020-04-21,,,2021-07-20,2020-04-21,2020-04-24,ACTUAL,,,,,,,2021-07-20,2021-07-27,ACTUAL,2020-04-16,ACTUAL,2020-04-16,2021-07,2021-07-31,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,SEVO-COVID19,,Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection,Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection,TERMINATED,,PHASE4,19.0,ACTUAL,Fundación para la Investigación del Hospital Clínico de Valencia,,2.0,,Low recruitment ratio,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 23:07:12.994837,2024-10-14 23:07:12.994837,OTHER,,,,,,,2021,0.0
NCT02666547,,2016-01-24,,,2024-06-17,2016-01-24,2016-01-28,ESTIMATED,,,,,,,2024-06-17,2024-06-20,ACTUAL,2014-03,ACTUAL,2014-03-31,2024-06,2024-06-30,2023-09,ACTUAL,2023-09-30,2023-08,ACTUAL,2023-08-31,,INTERVENTIONAL,,,68Ga-NODAGA-RGD PET/ CT for Tumoral Neoangiogenesis,Value of PET/ CT in the 68Ga-NODAGA-RGD for the Evaluation of the Tumoral Neoangiogenesis,TERMINATED,,PHASE1,42.0,ACTUAL,University of Lausanne Hospitals,,1.0,,lack of resources,f,,,,f,,,,,,,,,,,NO,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,OTHER,,,,,,,2023,0.0
NCT02371590,,2015-02-13,,,2018-02-21,2015-02-24,2015-02-25,ESTIMATED,,,,,,,2018-02-21,2018-02-23,ACTUAL,2018-02,ESTIMATED,2018-02-28,2018-02,2018-02-28,2022-12,ESTIMATED,2022-12-31,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,Lenalidomide and Obinutuzumab for Previously Untreated CLL,A Phase 2 Clinical Trial To Evaluate Lenalidomide And Obinutuzumab For The Treatment Of Patients With Not Previously Treated Chronic Lymphocytic Leukemia,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, San Diego",,1.0,,Study Not Activated Due to Contract Issues,f,,,,t,t,f,,,,,,,,,,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,OTHER,,,,,,,2022,0.0
NCT04890548,,2021-05-13,,,2021-12-02,2021-05-13,2021-05-18,ACTUAL,,,,,,,2021-12-02,2021-12-17,ACTUAL,2021-11-23,ESTIMATED,2021-11-23,2021-12,2021-12-31,2022-08-02,ESTIMATED,2022-08-02,2022-08-02,ESTIMATED,2022-08-02,,INTERVENTIONAL,,,Study to Evaluate the Effects of AZD3427 in Patients With Heart Failure,A Mechanistic Study to Evaluate the Vasodilatory Effects of AZD3427 in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF) and Patients With Heart Failure With Reduced Ejection Fraction (HFrEF),WITHDRAWN,,PHASE1,0.0,ACTUAL,AstraZeneca,,1.0,,"Study start up timelines delayed into late autumn, and with COVID cases rising in the UK, the feasibility of successfully recruiting the study and ethical concerns about starting a study that AZ may not be able to complete.",f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,INDUSTRY,,,,,,,2022,0.0
NCT03122652,,2017-04-12,,,2023-03-16,2017-04-18,2017-04-21,ACTUAL,,,,,,,2023-03-16,2023-03-17,ACTUAL,2017-09-25,ACTUAL,2017-09-25,2023-03,2023-03-31,2022-10-04,ACTUAL,2022-10-04,2019-02-05,ACTUAL,2019-02-05,,INTERVENTIONAL,TERIS,,"Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiologically Isolated Syndrome","Multi-center, Randomized, Double-blinded Study of Teriflunomide® in Radiologically Isolated Syndrome (RIS) The TERIS Study",COMPLETED,,PHASE3,125.0,ACTUAL,Centre Hospitalier Universitaire de Nice,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,OTHER,,,,,,,2022,1.0
NCT01954979,,2013-09-27,,,2024-01-16,2013-09-27,2013-10-07,ESTIMATED,,,,,,,2024-01-16,2024-01-18,ACTUAL,2014-03-27,ACTUAL,2014-03-27,2024-01,2024-01-31,2024-01-16,ACTUAL,2024-01-16,2023-06-01,ACTUAL,2023-06-01,,INTERVENTIONAL,,,Abatacept to Treat Steroid Refractory Chronic Graft Versus Host Disease (cGVHD),A Phase I Study of Abatacept in the Treatment of Patients With Steroid Refractory Chronic Graft Versus Host Disease (cGVHD),COMPLETED,,PHASE1,56.0,ACTUAL,Beth Israel Deaconess Medical Center,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,OTHER,,,,,,,2024,1.0
NCT05381974,,2022-05-10,,,2024-01-22,2022-05-16,2022-05-19,ACTUAL,,,,,,,2024-01-22,2024-01-24,ACTUAL,2022-09-15,ACTUAL,2022-09-15,2024-01,2024-01-31,2023-06-01,ACTUAL,2023-06-01,2023-06-01,ACTUAL,2023-06-01,,INTERVENTIONAL,,,The Effects of Psilocybin on Self-Focus and Self-Related Processing in Treatment Resistant MDD,The Effects of Psilocybin on Self-Focus and Self-Related Processing in Treatment Resistant MDD,WITHDRAWN,,PHASE2,0.0,ACTUAL,Massachusetts General Hospital,,1.0,,Study was terminated due to difficulty recruiting patients who met inclusion/exclusion criteria. No participants received the intervention.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,OTHER,,,,,,,2023,0.0
NCT02558010,,2015-02-13,2023-04-05,,2023-11-16,2015-09-22,2015-09-23,ESTIMATED,2023-04-25,2023-04-27,ACTUAL,,,,2023-11-16,2023-11-18,ACTUAL,2016-02-01,ACTUAL,2016-02-01,2023-11,2023-11-30,2023-01-01,ACTUAL,2023-01-01,2022-01-01,ACTUAL,2022-01-01,,INTERVENTIONAL,,,Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients,Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients,COMPLETED,,PHASE3,58.0,ACTUAL,Medical College of Wisconsin,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,OTHER,,,,,,,2023,1.0
NCT05538624,,2022-08-22,,,2024-04-23,2022-09-09,2022-09-14,ACTUAL,,,,,,,2024-04-23,2024-04-24,ACTUAL,2022-12-09,ACTUAL,2022-12-09,2024-04,2024-04-30,2024-04-10,ACTUAL,2024-04-10,2024-04-01,ACTUAL,2024-04-01,,INTERVENTIONAL,,,A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary,"A Phase 1/2 Open-Label, Multicenter, Dose Escalation and Expansion Study of AVB-001, an Intraperitoneally Administered, Cell-Generated, Human IL-2 Immunotherapy in Patients With Platinum-Resistant, High-Grade, Serous Adenocarcinoma of the Ovary, Primary Peritoneum, or Fallopian Tube",TERMINATED,,PHASE1/PHASE2,14.0,ACTUAL,"Avenge Bio, Inc",,1.0,,Sponsor Decision to close study,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,INDUSTRY,,,,,,,2024,0.0
NCT04061876,,2019-08-17,,,2023-11-25,2019-08-17,2019-08-20,ACTUAL,,,,,,,2023-11-25,2023-11-29,ACTUAL,2019-08-25,ACTUAL,2019-08-25,2023-11,2023-11-30,2023-06-30,ACTUAL,2023-06-30,2022-08-01,ACTUAL,2022-08-01,,INTERVENTIONAL,,,First Line Therapy for High Risk Acute GVHD,Ruxolitinib in Combination With Corticosteroid as First Line Therapy for the Treatment of High Risk Acute Graft-Versus-Host Disease,COMPLETED,,PHASE2,198.0,ACTUAL,Chinese PLA General Hospital,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,OTHER,,,,,,,2023,1.0
NCT03021590,,2017-01-05,,,2018-12-05,2017-01-12,2017-01-16,ESTIMATED,,,,,,,2018-12-05,2018-12-07,ACTUAL,2017-06-01,ACTUAL,2017-06-01,2018-12,2018-12-31,2022-01-31,ESTIMATED,2022-01-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori,Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori,WITHDRAWN,,PHASE4,0.0,ACTUAL,Damascus Hospital,,2.0,,No Participants Enrolled,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,OTHER,,,,,,,2022,0.0
NCT04052620,,2019-07-23,2021-11-11,,2022-02-14,2019-08-07,2019-08-12,ACTUAL,2022-02-14,2022-04-12,ACTUAL,,,,2022-02-14,2022-04-12,ACTUAL,2019-10-24,ACTUAL,2019-10-24,2022-02,2022-02-28,2020-11-12,ACTUAL,2020-11-12,2020-11-12,ACTUAL,2020-11-12,,INTERVENTIONAL,,Intent-to-treat (ITT) population: Comprise all randomized participants. This population was based on the treatment to which the participant was randomized. Any participant who received a treatment randomization number was considered to have been randomized.,Voltaren Emulgel 2% Acute Ankle Sprain Non Inferiority Study,"A Randomized, Double Blind, Multi Center, Active-controlled, 2 Treatment Arm, Parallel Group Non Inferiority Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Versus 1.16% Gel in Subjects With Acute Ankle Sprain",COMPLETED,,PHASE3,313.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,f,f,f,,,,,,IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be grated, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,INDUSTRY,,,,,,,2020,1.0
NCT03846583,,2019-02-13,,,2020-10-21,2019-02-15,2019-02-19,ACTUAL,,,,,,,2020-10-21,2020-10-23,ACTUAL,2020-06-28,ESTIMATED,2020-06-28,2020-10,2020-10-31,2020-09-22,ACTUAL,2020-09-22,2020-09-22,ACTUAL,2020-09-22,,INTERVENTIONAL,,,Tucatinib + Abemaciclib + Herceptin for HER2+ MBC,Phase Ib Trial of Tucatinib in Combination With Abemaciclib and Trastuzumab for Patients With HER2-Positive Metastatic Breast Cancer,WITHDRAWN,,PHASE1,0.0,ACTUAL,Dana-Farber Cancer Institute,,4.0,,"Study halted prematurely, prior to enrollment of first participant.",f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,OTHER,,,,,,,2020,0.0
NCT03099304,,2017-03-28,2021-09-09,2019-09-10,2022-10-25,2017-03-28,2017-04-04,ACTUAL,2021-12-08,2021-12-10,ACTUAL,2021-12-08,2021-12-10,ACTUAL,2022-10-25,2022-11-17,ACTUAL,2017-06-07,ACTUAL,2017-06-07,2022-10,2022-10-31,2021-09-08,ACTUAL,2021-09-08,2018-09-12,ACTUAL,2018-09-12,,INTERVENTIONAL,,,A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo,"A Randomized, Double-Blind, Dose-Ranging Study of INCB018424 Phosphate Cream in Subjects With Vitiligo",COMPLETED,,PHASE2,157.0,ACTUAL,Incyte Corporation,,5.0,,,,,,,f,t,f,,,,,,,,,NO,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,INDUSTRY,,,,,,,2021,1.0
NCT05542095,,2022-09-13,,,2023-06-08,2022-09-13,2022-09-15,ACTUAL,,,,,,,2023-06-08,2023-06-12,ACTUAL,2023-05-01,ACTUAL,2023-05-01,2023-05,2023-05-31,2023-05-01,ACTUAL,2023-05-01,2023-05-01,ACTUAL,2023-05-01,,INTERVENTIONAL,SimCA,,Simvastatin Nasal Rinses for the Treatment of COVID-19 Mediated Dysomsia,Simvastatin Nasal Rinses for the Treatment of COVID-19 Mediated Dysomsia,WITHDRAWN,,PHASE1,0.0,ACTUAL,Washington University School of Medicine,,4.0,,Study halted prematurely; IRB approval not obtained,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,OTHER,,,,,,,2023,0.0
NCT02574078,,2015-10-09,2021-03-15,,2021-04-12,2015-10-09,2015-10-12,ESTIMATED,2021-04-12,2021-05-06,ACTUAL,,,,2021-04-12,2021-05-06,ACTUAL,2015-11-23,ACTUAL,2015-11-23,2021-04,2021-04-30,2020-04-15,ACTUAL,2020-04-15,2020-04-15,ACTUAL,2020-04-15,,INTERVENTIONAL,CheckMate370,,A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC),A Master Protocol of Phase 1/2 Studies of Nivolumab in Advanced NSCLC Using Nivolumab as Maintenance After Induction Chemotherapy or as First-line Treatment Alone or in Combination With Standard of Care Therapies (CheckMate 370: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 370),COMPLETED,,PHASE1/PHASE2,341.0,ACTUAL,Bristol-Myers Squibb,,10.0,,,f,,,,t,,,,,,,,,,,,,2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,INDUSTRY,,,,,,,2020,1.0
NCT04535102,,2020-07-23,,,2022-05-03,2020-08-31,2020-09-01,ACTUAL,,,,,,,2022-05-03,2022-05-09,ACTUAL,2021-01-29,ACTUAL,2021-01-29,2022-05,2022-05-31,2022-03-17,ACTUAL,2022-03-17,2022-03-17,ACTUAL,2022-03-17,,INTERVENTIONAL,,,POLA+BR for Relapsed or Refractory DLBCL,POLATUZUMAB PLUS BENDAMUSTINE PLUS RITUXIMAB (POLA+BR) AS SALVAGE THERAPY PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANT FOR PATIENTS WITH RELAPSED OR PRIMARY REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of Colorado, Denver",,1.0,,Lack of sufficient patient population,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,OTHER,,,,,,,2022,0.0
NCT06007508,,2022-12-15,,,2024-06-14,2023-08-21,2023-08-23,ACTUAL,,,,,,,2024-06-14,2024-06-18,ACTUAL,2022-05-31,ACTUAL,2022-05-31,2024-01,2024-01-31,2023-02-28,ACTUAL,2023-02-28,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,,,Early Administration of Insulin Glargine in Patients With Diabetic Ketoacidosis,Early Administration of Insulin Glargine in Patients With Diabetic Ketoacidosis,TERMINATED,,PHASE2,8.0,ACTUAL,HealthPartners Institute,,2.0,,Study intervention was adopted as standard of care.,f,,,,f,t,f,,,t,,,,,,NO,There is no plan to share IPD with investigators not currently involved in the study.,2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,OTHER,,,,,,,2023,0.0
NCT04154293,,2019-11-01,2022-07-10,,2022-08-03,2019-11-04,2019-11-06,ACTUAL,2022-08-03,2022-08-25,ACTUAL,,,,2022-08-03,2022-08-25,ACTUAL,2019-12-03,ACTUAL,2019-12-03,2022-08,2022-08-31,2021-08-30,ACTUAL,2021-08-30,2021-08-20,ACTUAL,2021-08-20,,INTERVENTIONAL,,All subjects who received at least one dose of study drug (TMB-001 0.1% or TMB-001 0.05%) or vehicle,A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis,"A Randomized, Parallel, Double-Blind, Vehicle Controlled Study to Evaluate the Safety and Efficacy of Two Concentrations of Topical TMB-001 for the Treatment of Congenital Ichthyosis",COMPLETED,,PHASE2,34.0,ACTUAL,Timber Pharmaceuticals Inc.,small sample size. study not powered for statistical significance.,3.0,,,f,,,,f,t,f,,,f,,,,,,,,2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,INDUSTRY,,,,,,,2021,0.0
NCT01690702,,2012-08-29,,,2021-02-01,2012-09-21,2012-09-24,ESTIMATED,,,,,,,2021-02-01,2021-02-02,ACTUAL,2012-09,,2012-09-30,2021-02,2021-02-28,2020-07-20,ACTUAL,2020-07-20,2018-09-30,ACTUAL,2018-09-30,,INTERVENTIONAL,GAIN-2,,Study of Nab-Paclitaxel in High Risk Early Breast Cancer,Neo-/Adjuvant Phase III Trial to Compare Intense Dose-dense Chemotherapy to Tailored Dose-dense Chemotherapy in Patients With High-risk Early Breast Cancer (GAIN-2),COMPLETED,,PHASE3,2886.0,ACTUAL,German Breast Group,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,OTHER,,,,,,,2020,1.0
NCT04702698,,2021-01-07,,,2021-05-11,2021-01-07,2021-01-11,ACTUAL,,,,,,,2021-05-11,2021-05-12,ACTUAL,2021-01-14,ACTUAL,2021-01-14,2021-04,2021-04-30,2021-03-03,ACTUAL,2021-03-03,2021-03-03,ACTUAL,2021-03-03,,INTERVENTIONAL,,,Effect of Food on Peposertib PK,"Phase I, Open-Label, Randomized, Single-Dose Study With Crossover Design to Investigate the Effect of Food on the PK of Peposertib Tablet Formulation and to Investigate the PK of Peposertib Administered as Oral Suspension of Disintegrated Tablets",COMPLETED,,PHASE1,12.0,ACTUAL,"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany",,8.0,,,f,,,,f,f,f,,,,,,,,,NO,"Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html",2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,INDUSTRY,,,,,,,2021,1.0
NCT05100160,,2021-09-22,,,2023-04-11,2021-10-27,2021-10-29,ACTUAL,,,,,,,2023-04-11,2023-04-13,ACTUAL,2021-09-15,ACTUAL,2021-09-15,2023-04,2023-04-30,2023-01-03,ACTUAL,2023-01-03,2023-01-03,ACTUAL,2023-01-03,,INTERVENTIONAL,,,Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial),Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial),WITHDRAWN,,PHASE3,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,0 patient accrual,f,,,,f,t,f,,,,,,,,,,,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,OTHER,,,,,,,2023,0.0
NCT02505087,,2015-06-25,,,2020-09-28,2015-07-20,2015-07-22,ESTIMATED,,,,,,,2020-09-28,2020-09-29,ACTUAL,2015-09,ACTUAL,2015-09-30,2017-11,2017-11-30,2020-08-31,ACTUAL,2020-08-31,2018-04-24,ACTUAL,2018-04-24,,INTERVENTIONAL,SelNac,,Pharmacological Treatment of a Rare Genetic Disease: N-acetylcysteine in Myopathy Associated Selenoprotein N-related Myopathy (SEPN1-RM),Pharmacological Treatment of a Rare Genetic Disease: Pilot Trial Phase II-III With N-acetylcysteine in Myopathy Associated SEPN1-RM (Selenoprotein N-related Myopathy),TERMINATED,,PHASE2/PHASE3,7.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,3.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,OTHER,,,,,,,2020,0.0
NCT05172050,,2021-12-23,2022-06-06,,2023-12-21,2021-12-23,2021-12-29,ACTUAL,2023-03-17,2023-12-14,ACTUAL,,,,2023-12-21,2023-12-26,ACTUAL,2021-01-22,ACTUAL,2021-01-22,2022-06,2022-06-30,2021-06-12,ACTUAL,2021-06-12,2021-06-12,ACTUAL,2021-06-12,,INTERVENTIONAL,,"The Full Analysis Set (FAS) population included all randomized patients who received at least one dose of the study medication. The FAS population was used for demographics, and primary and secondary efficacy analyses","Multicenter Double Blind, Parallel-group Phase 2/3 Trial, to Study Raloxifene in Adult COVID-19 Patients.","Multicenter, Adaptive, Randomized, Placebo-controlled, Double Blind, Parallel-group Phase 2/3 Trial, to Study Efficacy and Safety of Two Doses of Raloxifene in Adult Paucisymptomatic COVID-19 Patients.",COMPLETED,,PHASE2/PHASE3,61.0,ACTUAL,Dompé Farmaceutici S.p.A,,3.0,,,f,,,,,f,f,,,f,,,,,,NO,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,INDUSTRY,,,,,,,2021,1.0
NCT02256436,,2014-09-29,2017-06-12,,2021-08-23,2014-10-02,2014-10-03,ESTIMATED,2017-07-28,2017-08-31,ACTUAL,,,,2021-08-23,2021-09-20,ACTUAL,2014-10-22,ACTUAL,2014-10-22,2021-08,2021-08-31,2020-10-01,ACTUAL,2020-10-01,2016-09-07,ACTUAL,2016-09-07,,INTERVENTIONAL,,,"A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045)","A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel or Vinflunine in Subjects With Recurrent or Progressive Metastatic Urothelial Cancer",COMPLETED,,PHASE3,542.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 19:57:21.019672,2024-10-16 19:57:21.019672,INDUSTRY,,,,,,,2020,1.0
NCT04580407,,2020-10-05,,,2022-12-27,2020-10-05,2020-10-08,ACTUAL,,,,,,,2022-12-27,2022-12-29,ACTUAL,2021-11-09,ACTUAL,2021-11-09,2022-12,2022-12-31,2022-11-29,ACTUAL,2022-11-29,2022-11-29,ACTUAL,2022-11-29,,INTERVENTIONAL,,,Study of TAK-672 in Participants With Acquired Hemophilia A,"A Phase 2/3, Open-Label, Non-controlled Study to Evaluate the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (rpFVIII, TAK-672), in the Treatment of Serious Bleeding Episode in Japanese Subjects With Acquired Hemophilia A (AHA)",COMPLETED,,PHASE2/PHASE3,5.0,ACTUAL,Takeda,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites.,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,INDUSTRY,,,,,,,2022,0.0
NCT03300505,,2017-09-28,,,2024-01-23,2017-09-28,2017-10-03,ACTUAL,,,,,,,2024-01-23,2024-01-25,ACTUAL,2019-05-31,ACTUAL,2019-05-31,2024-01,2024-01-31,2023-01-24,ACTUAL,2023-01-24,2023-01-24,ACTUAL,2023-01-24,,INTERVENTIONAL,,,ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer,"ARRO-CITO: (UMCC 2017.055) Phase Ib/II Single-Arm Multi-Center Study of IONIS-AR-2.5Rx, a Next Generation Androgen Receptor Antisense Oligonucleotide, in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer",TERMINATED,,PHASE1,9.0,ACTUAL,University of Michigan Rogel Cancer Center,,1.0,,Cancelled by the sponsor,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:52:41.439168,2024-10-15 23:52:41.439168,OTHER,,,,,,,2023,0.0
NCT02973295,,2016-11-04,,,2020-11-03,2016-11-21,2016-11-25,ESTIMATED,,,,,,,2020-11-03,2020-11-05,ACTUAL,2019-09-20,ACTUAL,2019-09-20,2020-11,2020-11-30,2021-06-30,ESTIMATED,2021-06-30,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,SINF,,Silymarin in NAFLD,Silymarin® - Efficacy in Treatment of Non-alcoholic Fatty Liver Disease (NAFLD) Controlled by Laboratory and and Elastographic Parameters,WITHDRAWN,,PHASE4,0.0,ACTUAL,University Hospital Rijeka,,2.0,,Sponsor withdrawn their agreement,f,,,,t,f,f,,,,,,,,,YES,All patient data will be available to other researchers after interim analysis,2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,OTHER,,,,,,,2021,0.0
NCT03316118,,2017-10-05,2022-06-21,,2022-09-14,2017-10-18,2017-10-20,ACTUAL,2022-09-14,2022-09-28,ACTUAL,,,,2022-09-14,2022-09-28,ACTUAL,2017-10-05,ACTUAL,2017-10-05,2022-09,2022-09-30,2021-06-21,ACTUAL,2021-06-21,2021-06-21,ACTUAL,2021-06-21,,INTERVENTIONAL,,Study terminated early due to low enrollment.,US Guided GNB vs Saline Injection for TKA,"A Comparison of Analgesic Efficacy of Ultrasound-Guided Genicular Nerve Block Versus Saline Injection for Total Knee Replacement: a Prospective, Randomized Controlled Trial",TERMINATED,,PHASE4,2.0,ACTUAL,Northwestern University,The limitation to the results is that the study was terminated early for low enrollment.,2.0,,Low Enrollment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,OTHER,,,,,,,2021,0.0
NCT04493424,,2020-07-28,2024-01-15,,2024-02-21,2020-07-28,2020-07-30,ACTUAL,2024-02-21,2024-03-20,ACTUAL,,,,2024-02-21,2024-03-20,ACTUAL,2020-09-04,ACTUAL,2020-09-04,2024-02,2024-02-29,2023-05-15,ACTUAL,2023-05-15,2023-01-16,ACTUAL,2023-01-16,,INTERVENTIONAL,,The safety analysis set for maintenance treatment (SAF-MT): Included all patients who received at least one dose of the maintenance treatment Spesolimab (BI 655130).,A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab,"An Open-label, Long Term Safety Trial of Spesolimab Treatment in Patients With Palmoplantar Pustulosis (PPP) Who Have Completed Previous BI Spesolimab Trials",TERMINATED,,PHASE2,108.0,ACTUAL,Boehringer Ingelheim,The trial was prematurely discontinued due to the sponsor's (Boehringer Ingelheim) decision to terminate the clinical program studying spesolimab in patients with PPP. This decision was not based on any safety finding in the clinical trials.,1.0,,Sponsor decision,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,INDUSTRY,,,,,,,2023,0.0
NCT04187547,,2019-11-29,,,2023-04-12,2019-12-03,2019-12-05,ACTUAL,,,,,,,2023-04-12,2023-04-14,ACTUAL,2022-06-30,ESTIMATED,2022-06-30,2023-04,2023-04-30,2024-02-28,ESTIMATED,2024-02-28,2023-12-31,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,A Phase III Multi Regional Clinical Trial (MRCT) of Tricaprilin in Mild to Moderately Severe Probable Alzheimer's Disease With Optional Open Label Extension,"A Phase III, 26-Week, Double-blind, Randomised, Placebo-controlled, Parallel-group Trial to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-SD-03 in Subjects With Mild to Moderately Severe Probable Alzheimer's Disease and Who Are Noncarriers of the APOE4 Allele",WITHDRAWN,,PHASE3,0.0,ACTUAL,Cerecin,,2.0,,Study replaced with a new study,f,,,,t,t,f,,,,,,,,,,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,INDUSTRY,,,,,,,2024,0.0
NCT02684617,,2016-02-12,2021-02-09,,2021-02-09,2016-02-12,2016-02-18,ESTIMATED,2021-02-09,2021-03-01,ACTUAL,,,,2021-02-09,2021-03-01,ACTUAL,2016-03-29,ACTUAL,2016-03-29,2021-02,2021-02-28,2020-04-06,ACTUAL,2020-04-06,2020-04-06,ACTUAL,2020-04-06,,INTERVENTIONAL,,,Study of Pembrolizumab (MK-3475) in Combination With Dinaciclib (MK-7965) in Hematologic Malignancies (MK-3475-155/KEYNOTE-155),Phase Ib Trial of Pembrolizumab (MK-3475) in Combination With Dinaciclib (MK-7965) in Subjects With Hematologic Malignancies (KEYNOTE-155).,TERMINATED,,PHASE1,75.0,ACTUAL,Merck Sharp & Dohme LLC,,3.0,,Business Reasons,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,INDUSTRY,,,,,,,2020,0.0
NCT05286567,,2022-03-10,,,2023-01-30,2022-03-10,2022-03-18,ACTUAL,,,,,,,2023-01-30,2023-01-31,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2023-01,2023-01-31,2022-08-29,ACTUAL,2022-08-29,2022-08-29,ACTUAL,2022-08-29,,INTERVENTIONAL,,,A Double-blind Placebo-controlled Randomized Trial Evaluating the Efficacy and Safety of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Supppurativa.,"An Investigator Initiated, Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Proof-Of-Concept Study to Assess the Safety and Efficacy of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Suppurativa",COMPLETED,,PHASE1,15.0,ACTUAL,Aarhus University Hospital,,2.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,OTHER,,,,,,,2022,1.0
NCT02841579,,2016-07-08,,,2020-11-25,2016-07-21,2016-07-22,ESTIMATED,,,,,,,2020-11-25,2020-11-27,ACTUAL,2016-08,ACTUAL,2016-08-31,2019-09,2019-09-30,2020-02,ACTUAL,2020-02-29,2018-12,ACTUAL,2018-12-31,,INTERVENTIONAL,AZENT,,Osimertinib (AZD9291) in First-line Locally Advanced or Metastatic NSCLC Patients With EGFR and EGFR T790M,A Phase IIa Clinical Trial to Evaluate the Safety and Efficacy of Osimertinib (AZD9291) in First-line Patients With EGFR Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer and Concomitant EGFR T790M Mutation at Time of Diagnosis,COMPLETED,,PHASE2,22.0,ACTUAL,MedSIR,,1.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,OTHER,,,,,,,2020,1.0
NCT03550443,,2018-05-14,,,2023-09-22,2018-06-07,2018-06-08,ACTUAL,,,,,,,2023-09-22,2023-09-26,ACTUAL,2018-05-30,ACTUAL,2018-05-30,2023-09,2023-09-30,2023-07-31,ACTUAL,2023-07-31,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,,,A Phase 3 Study of Bardoxolone Methyl in Patients With Diabetic Kidney Disease; AYAME Study,"RTA 402 Phase 3 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Diabetic Kidney Disease)",TERMINATED,,PHASE3,1323.0,ACTUAL,"Kyowa Kirin Co., Ltd.",,2.0,,"Based on results of double-blind parts, it was determined that it would be difficult to submit a marketing authorization application for RTA 402 for diabetic kidney disease.",f,,,,t,f,f,,,f,,,,,,NO,,2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,INDUSTRY,,,,,,,2023,0.0
NCT03481842,,2018-03-08,,,2021-10-24,2018-03-22,2018-03-29,ACTUAL,,,,,,,2021-10-24,2021-10-29,ACTUAL,2021-10-10,ESTIMATED,2021-10-10,2021-10,2021-10-31,2021-10-10,ESTIMATED,2021-10-10,2021-10-10,ESTIMATED,2021-10-10,,INTERVENTIONAL,ELTA,,"Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis","Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,BioGene Pharmaceutical Ltd.,,1.0,,Change in study design and sponsor,f,,,,t,f,f,,,,,,,,,,,2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,INDUSTRY,,,,,,,2021,0.0
NCT02038777,,2014-01-14,2022-01-12,,2024-01-10,2014-01-14,2014-01-17,ESTIMATED,2022-01-12,2022-03-18,ACTUAL,,,,2024-01-10,2024-01-12,ACTUAL,2014-03-25,ACTUAL,2014-03-25,2024-01,2024-01-31,2023-12-28,ACTUAL,2023-12-28,2021-02-12,ACTUAL,2021-02-12,,INTERVENTIONAL,,Safety analysis set included all enrolled participants who received at least 1 dose of study medication.,A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies,"A PHASE 1 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF-04449913 (GLASDEGIB), AN ORAL HEDGEHOG INHIBITOR, ADMINISTERED AS A SINGLE AGENT IN JAPANESE PATIENTS WITH SELECT HEMATOLOGIC MALIGNANCIES AND IN COMBINATION WITH INTENSIVE CHEMOTHERAPY, LOW-DOSE ARA-C, OR AZACITIDINE IN PATIENTS WITH ACUTE MYELOID LEUKEMIA OR HIGH-RISK MYELODYSPLASTIC SYNDROME",COMPLETED,,PHASE1,48.0,ACTUAL,Pfizer,,6.0,,,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,INDUSTRY,,,,,,,2023,1.0
NCT04140539,,2019-10-24,,,2022-08-01,2019-10-24,2019-10-28,ACTUAL,,,,,,,2022-08-01,2022-08-03,ACTUAL,2019-10-15,ACTUAL,2019-10-15,2022-08,2022-08-31,2021-08-30,ACTUAL,2021-08-30,2021-08-30,ACTUAL,2021-08-30,,INTERVENTIONAL,,,A Clinical Study to Enable Process Validation of Commercial Grade OTL-101,"A Single Arm, Open Label Clinical Study to Enable Process Validation of Commercial Grade Ex Vivo Hematopoietic Stem Cell Gene Therapy (OTL-101) in Subjects With Severe Combined Immunodeficiency Due to Adenosine Deaminase Deficiency (ADA-SCID)",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,"University of California, Los Angeles",,1.0,,Recruitment on hold for business reasons. Study will not be performed.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,OTHER,,,,,,,2021,0.0
NCT04294459,,2020-02-19,2023-05-01,,2023-05-31,2020-03-02,2020-03-04,ACTUAL,2023-05-01,2023-05-30,ACTUAL,,,,2023-05-31,2023-06-27,ACTUAL,2020-06-18,ACTUAL,2020-06-18,2023-05,2023-05-31,2022-05-02,ACTUAL,2022-05-02,2022-05-02,ACTUAL,2022-05-02,,INTERVENTIONAL,,Analysis was performed on all enrolled participants.,"Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation","A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab (SAR650984) in Patients Awaiting Kidney Transplantation",TERMINATED,,PHASE1/PHASE2,23.0,ACTUAL,Sanofi,"Sponsor decided to terminate the study for non-safety reasons on 02 May 2022. Based on available clinical data at time of interim analysis, it was determined that enrollment of the remaining participants was unlikely to have any significant impact on the study results and hence the trial was stopped. All 23 participants enrolled in the study were followed-up per protocol until the planned study termination date.",2.0,,Terminated due to non-safety reasons,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,INDUSTRY,,,,,,,2022,0.0
NCT04166773,,2019-11-15,,,2024-04-17,2019-11-15,2019-11-18,ACTUAL,,,,,,,2024-04-17,2024-04-18,ACTUAL,2019-11-19,ACTUAL,2019-11-19,2024-04,2024-04-30,2024-01-10,ACTUAL,2024-01-10,2023-12-11,ACTUAL,2023-12-11,,INTERVENTIONAL,SYNERGY-NASH,,A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH),"A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)",COMPLETED,,PHASE2,196.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-14 23:13:29.242034,2024-10-14 23:13:29.242034,INDUSTRY,,,,,,,2024,1.0
NCT03802630,,2019-01-10,2022-07-01,,2023-01-27,2019-01-10,2019-01-14,ACTUAL,2022-07-01,2022-07-28,ACTUAL,,,,2023-01-27,2023-01-30,ACTUAL,2019-07-02,ACTUAL,2019-07-02,2023-01,2023-01-31,2021-07-26,ACTUAL,2021-07-26,2021-07-26,ACTUAL,2021-07-26,,INTERVENTIONAL,RAPTOR,,Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion,"An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion",TERMINATED,,PHASE3,450.0,ACTUAL,Novartis,,2.0,,"Study was terminated by sponsor due to increased incidences of AEs of special interest (intraocular inflammation including retinal vasculitis and retinal vascular occlusion), in patients dosed brolucizumab 6mg every 4 weeks beyond 3 initial doses",f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,INDUSTRY,,,,,,,2021,0.0
NCT03697824,,2018-10-04,,,2019-10-26,2018-10-04,2018-10-05,ACTUAL,,,,,,,2019-10-26,2019-10-29,ACTUAL,2019-02-25,ESTIMATED,2019-02-25,2019-10,2019-10-31,2022-07-18,ESTIMATED,2022-07-18,2022-07-18,ESTIMATED,2022-07-18,,INTERVENTIONAL,,,"Clinical Trial of Safety, Tolerability and Antitumor Activity of Genetically Engineered T Cells in Combination With Anti-Cancer Agents in Relapsed and Refractory Synovial Sarcoma Expressing New York Esophageal Antigen-1 (NY-ESO-1) and/or LAGE-1a","Open-Label Phase 1b/2a Clinical Trial to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered NY-ESO-1 Specific (c259) T Cells (GSK3377794) in Combination With Anti-Cancer Agents Including Pembrolizumab in HLA-A2+ Participants With NY-ESO-1 and/or LAGE-1a Positive Relapsed and Refractory Synovial Sarcoma",WITHDRAWN,,PHASE2,0.0,ACTUAL,GlaxoSmithKline,,1.0,,"Internal decision, study will be replaced with a larger monotherapy trial",f,,,,f,t,f,,,,,,IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,INDUSTRY,,,,,,,2022,0.0
NCT02283905,,2014-10-31,,,2020-09-25,2014-11-04,2014-11-05,ESTIMATED,,,,,,,2020-09-25,2020-09-29,ACTUAL,2015-06,ACTUAL,2015-06-30,2020-09,2020-09-30,2020-09-25,ACTUAL,2020-09-25,2020-09-25,ACTUAL,2020-09-25,,INTERVENTIONAL,BLASTO,,Amphotericin-B and Voriconazole for Pulmonary Blastomycosis,Case Series of Continuously-infused Amphotericin-B and Follow-up Voriconazole Therapy for Severe Blastomycosis Pulmonary Infections,TERMINATED,,PHASE4,2.0,ACTUAL,University of Manitoba,,1.0,,Poor enrollment numbers of patients,f,,,,f,,,,,,,,,,,NO,,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,OTHER,,,,,,,2020,0.0
NCT04172597,,2019-11-19,2024-02-13,,2024-02-13,2019-11-19,2019-11-21,ACTUAL,2024-02-13,2024-03-13,ACTUAL,,,,2024-02-13,2024-03-13,ACTUAL,2019-12-23,ACTUAL,2019-12-23,2024-02,2024-02-29,2022-03-29,ACTUAL,2022-03-29,2022-03-29,ACTUAL,2022-03-29,,INTERVENTIONAL,,"The study was terminated by the Sponsor. Based on the low enrollment number (n=1), no data is reported here to protect and maintain participant privacy/confidentiality.",A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies,A Phase 2 Study of Poziotinib in Patients With EGFR or HER2 Activating Mutations in Advanced Malignancies,TERMINATED,,PHASE2,1.0,ACTUAL,"Spectrum Pharmaceuticals, Inc",,5.0,,Strategic business decision (unrelated to safety),f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,INDUSTRY,,,,,,,2022,0.0
NCT04411914,,2020-05-20,2023-01-20,,2023-06-15,2020-05-28,2020-06-02,ACTUAL,2023-06-15,2023-06-22,ACTUAL,,,,2023-06-15,2023-06-22,ACTUAL,2020-09-01,ACTUAL,2020-09-01,2023-06,2023-06-30,2022-03-31,ACTUAL,2022-03-31,2021-11-23,ACTUAL,2021-11-23,,INTERVENTIONAL,,,Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid,"A Phase 1B Double Blind, Placebo (PBO) Controlled, Pharmaco- Magnetic Resonance Spectroscopy (MRS) Inpatient Study of Clavulanic Acid (CLAV) 500, 750, 1000 mg Daily Repeated Administration in Early Remitted Cocaine Use Disorder Subjects",COMPLETED,,PHASE1,13.0,ACTUAL,Temple University,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,OTHER,,,,,,,2022,1.0
NCT05254236,,2022-02-20,,,2023-09-21,2022-02-20,2022-02-24,ACTUAL,,,,,,,2023-09-21,2023-09-22,ACTUAL,2022-02-10,ACTUAL,2022-02-10,2023-09,2023-09-30,2022-03-10,ESTIMATED,2022-03-10,2022-03-10,ACTUAL,2022-03-10,,INTERVENTIONAL,,,Immunogenicity and Safety Study of the 3rd Booster Dose Using the High or Medium Dose of Inactivated Vaccine in Healthy Adults in in Hong Kong,"A Phase IIb, Randomized, Double-Blinded Trial to Evaluate the Immunogenicity and Safety Study of the Booster Dose Using the High or Medium Dose of COVID- 19 Vaccine (Vero Cell), Inactivated in Healthy Adults Who Have Completed Two Doses of mRNA Vaccine in Hong Kong",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Sinovac Biotech Co., Ltd",,2.0,,Limited subjects,f,,,,f,f,f,,,,,,,,,,,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,INDUSTRY,,,,,,,2022,0.0
NCT02454855,,2015-05-12,,,2022-06-10,2015-05-22,2015-05-27,ESTIMATED,,,,,,,2022-06-10,2022-06-13,ACTUAL,2015-07,ACTUAL,2015-07-31,2022-03,2022-03-31,2022-02,ACTUAL,2022-02-28,2021-05,ACTUAL,2021-05-31,,INTERVENTIONAL,MEQAPAG,,Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients,Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients (> = 70 Years) - PHRC-K13-170,TERMINATED,,PHASE3,123.0,ACTUAL,Centre Jean Perrin,,2.0,,The study stopped for futility after the DSMB.,f,,,,t,,,,,,,,,,,,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,OTHER,,,,,,,2022,0.0
NCT05073484,,2021-09-09,,,2023-10-09,2021-09-28,2021-10-11,ACTUAL,,,,,,,2023-10-09,2023-10-11,ACTUAL,2021-10-29,ACTUAL,2021-10-29,2023-10,2023-10-31,2023-03-30,ACTUAL,2023-03-30,2023-03-30,ACTUAL,2023-03-30,,INTERVENTIONAL,,,Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients,"A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6021 as Mono Therapy or in Combination With BAT1308 in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1,13.0,ACTUAL,Bio-Thera Solutions,,9.0,,"Based on the disclosed global research data on the same target drugs, the company has carefully considered and decided to terminate the project to optimize the existing research pipeline.",f,,,,f,f,f,,,f,,,,,,NO,no plan to share IPD,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,INDUSTRY,,,,,,,2023,0.0
NCT05210088,,2021-10-05,,,2024-06-03,2022-01-13,2022-01-27,ACTUAL,,,,,,,2024-06-03,2024-06-04,ACTUAL,2024-01-01,ACTUAL,2024-01-01,2024-06,2024-06-30,2024-01-01,ACTUAL,2024-01-01,2024-01-01,ACTUAL,2024-01-01,,INTERVENTIONAL,PLASTIHC,,"PLAsticity, Security and Tolerance to Intermittent Hypoxic Conditioning Following Stroke","PLAsticity, Security and Tolerance to Intermittent Hypoxic Conditioning Following Stroke",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"University Hospital, Grenoble",,3.0,,faisability,f,,,,t,f,f,,,,,,After the publication of the results of the present study.,"Data collected for the study, including deidentified individual participant data will be made available to others following the publication of this article, for academic purposes (e.g., meta-analyses) on request to the principal investigator.",,YES,"Data collected for the study, including deidentified individual participant data will be made available to others following the publication of this article, for academic purposes (e.g., meta-analyses) on request to the principal investigator, after the publication of the results of the present study.",2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,OTHER,,,,,,,2024,0.0
NCT04842292,,2021-04-08,2022-09-21,,2022-10-17,2021-04-12,2021-04-13,ACTUAL,2022-10-17,2022-10-18,ACTUAL,,,,2022-10-17,2022-10-18,ACTUAL,2021-05-20,ACTUAL,2021-05-20,2022-10,2022-10-31,2021-09-04,ACTUAL,2021-09-04,2021-09-04,ACTUAL,2021-09-04,,INTERVENTIONAL,,Two participants were enrolled.,Nebulized Heparin for COVID19-associated Acute Respiratory Failure,Utilization of Nebulized Heparin for Patients Receiving Mechanical Ventilation for COVID19-associated Acute Respiratory Failure,TERMINATED,,PHASE2,2.0,ACTUAL,University of Kentucky,,2.0,,Lack of enrollment,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,OTHER,,,,,,,2021,0.0
NCT02107118,,2014-04-03,,,2015-05-22,2014-04-04,2014-04-08,ESTIMATED,,,,,,,2015-05-22,2015-05-25,ESTIMATED,2015-05,,2015-05-31,2015-05,2015-05-31,2022-02,ESTIMATED,2022-02-28,2020-03,ESTIMATED,2020-03-31,,INTERVENTIONAL,,,Stem Cells for the Improvement of Erectile and Cardiac Function in Aging Men,H-34570: PHASE I Study: The Use of Autologous Adipose Tissue-Derived Mesenchymal Stem Cell (AdMSC) for the Improvement of Erectile and Cardiac Function in Aging Men,WITHDRAWN,,PHASE1,0.0,ACTUAL,Baylor College of Medicine,,2.0,,Contract issues,f,,,,f,,,,,,,,,,,,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,OTHER,,,,,,,2022,0.0
NCT02954523,,2016-10-25,2022-11-29,,2024-07-02,2016-11-02,2016-11-03,ESTIMATED,2024-07-02,2024-07-05,ACTUAL,,,,2024-07-02,2024-07-05,ACTUAL,2016-10,ACTUAL,2016-10-31,2024-07,2024-07-31,2023-03-03,ACTUAL,2023-03-03,2018-08,ACTUAL,2018-08-31,,INTERVENTIONAL,,,Dasatinib and Osimertinib (AZD9291) in Advanced Non-Small Cell Lung Cancer With EGFR Mutations,Phase I/II Study of Dasatinib and Osimertinib (AZD9291) in Patients With Advanced Non-small Cell Lung Cancer With EGFR Mutations,TERMINATED,,PHASE1/PHASE2,10.0,ACTUAL,Georgetown University,,5.0,,Lack of accrual,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,OTHER,,,,,,,2023,0.0
NCT04718402,,2020-12-14,,,2024-03-05,2021-01-20,2021-01-22,ACTUAL,,,,,,,2024-03-05,2024-03-07,ACTUAL,2021-03-30,ACTUAL,2021-03-30,2021-05,2021-05-31,2022-05-30,ACTUAL,2022-05-30,2022-05-30,ACTUAL,2022-05-30,,INTERVENTIONAL,,,A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Gastric Carcinoma,"A Multicenter, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Gastric Carcinoma",TERMINATED,,PHASE1,21.0,ACTUAL,"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.",,1.0,,The sponsor has adjusted its R\&D strategy.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,INDUSTRY,,,,,,,2022,0.0
NCT01996696,,2013-11-22,,,2024-01-29,2013-11-22,2013-11-27,ESTIMATED,,,,,,,2024-01-29,2024-01-30,ACTUAL,2014-09,,2014-09-30,2024-01,2024-01-31,2020-11,ACTUAL,2020-11-30,2020-11,ACTUAL,2020-11-30,,INTERVENTIONAL,PREMIUM,,Prevention of Metabolic Syndrome and Increased Weight Using Metformin Concurrent to Androgen Deprivation Therapy and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate,Prevention of Metabolic Syndrome and Increased Weight Using Metformin Concurrent to Androgen Deprivation Therapy and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate,TERMINATED,,PHASE2,83.0,ACTUAL,AHS Cancer Control Alberta,,2.0,,Results of interim analysis indicate no statistically significant difference in the primary objective between the two arms at baseline and 12 months of follow-up.,f,,,,t,,,,,,,,,,,NO,,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,OTHER,,,,,,,2020,0.0
NCT05059301,,2021-09-17,2023-01-21,,2023-01-21,2021-09-17,2021-09-28,ACTUAL,2023-01-21,2023-02-15,ACTUAL,,,,2023-01-21,2023-02-15,ACTUAL,2021-10-01,ACTUAL,2021-10-01,2023-01,2023-01-31,2022-06-30,ACTUAL,2022-06-30,2022-01-24,ACTUAL,2022-01-24,,INTERVENTIONAL,,,A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above,"A Phase 3, Randomized, Double-blind, Multi-country Study to Evaluate Consistency, Safety, and Reactogenicity of 3 Lots of RSVPreF3 OA Investigational Vaccine Administrated as a Single Dose in Adults Aged 60 Years and Above",COMPLETED,,PHASE3,770.0,ACTUAL,GlaxoSmithKline,,3.0,,,f,,,,f,t,f,,,f,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,INDUSTRY,,,,,,,2022,1.0
NCT03643952,,2018-08-21,2021-03-03,,2022-04-19,2018-08-21,2018-08-23,ACTUAL,2021-03-03,2021-03-30,ACTUAL,,,,2022-04-19,2022-05-13,ACTUAL,2018-12-06,ACTUAL,2018-12-06,2022-04,2022-04-30,2020-04-07,ACTUAL,2020-04-07,2020-04-07,ACTUAL,2020-04-07,,INTERVENTIONAL,,,"Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)","A Phase II Open-Label, Single-arm Clinical Trial to Study the Safety, Efficacy and Pharmacokinetics of MK-3009 (Daptomycin) in Japanese Pediatric Participants Aged 1 to 17 Years With Complicated Skin and Soft Tissue Infections or Bacteremia Caused by Gram-positive Cocci",COMPLETED,,PHASE2,18.0,ACTUAL,Merck Sharp & Dohme LLC,"The study was concluded due to the difficulty of enrolling pediatric patients into the study during the COVID-19 pandemic. This study concluded enrollment with 18 participants, versus the 20 that were originally planned.",1.0,,,f,,,,f,f,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,INDUSTRY,,,,,,,2020,1.0
NCT02561481,,2015-09-24,2020-02-11,,2020-12-15,2015-09-24,2015-09-28,ESTIMATED,2020-11-23,2020-11-25,ACTUAL,,,,2020-12-15,2020-12-17,ACTUAL,2015-12,ACTUAL,2015-12-31,2020-12,2020-12-31,2020-01,ACTUAL,2020-01-31,2018-12,ACTUAL,2018-12-31,,INTERVENTIONAL,,,Sulforaphane Treatment of Children With Autism Spectrum Disorder (ASD),Sulforaphane Treatment of Children With Autism Spectrum Disorder (ASD),COMPLETED,,PHASE1/PHASE2,60.0,ACTUAL,"University of Massachusetts, Worcester",The sample size was limited to 45 children with ASD and we could not impute missing data for those participants who were lost to follow up.,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,OTHER,,,,,,,2020,0.0
NCT03971474,,2019-05-29,2023-03-01,,2024-08-14,2019-05-30,2019-06-03,ACTUAL,2023-03-31,2023-04-25,ACTUAL,,,,2024-08-14,2024-09-03,ACTUAL,2019-05-28,ACTUAL,2019-05-28,2024-08,2024-08-31,2024-01-01,ACTUAL,2024-01-01,2022-04-14,ACTUAL,2022-04-14,,INTERVENTIONAL,,Participants who are eligible and evaluable for the primary analysis,Ramucirumab and Pembrolizumab Versus Standard of Care in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Non-Match Treatment Trial),A Phase II Randomized Study of Ramucirumab Plus MK3475 (Pembrolizumab) Versus Standard of Care for Patients Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study),COMPLETED,,PHASE2,166.0,ACTUAL,SWOG Cancer Research Network,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,NETWORK,,,,,,,2024,1.0
NCT02899195,,2016-09-08,2021-02-16,,2023-06-29,2016-09-08,2016-09-14,ESTIMATED,2021-03-11,2021-04-06,ACTUAL,,,,2023-06-29,2023-07-05,ACTUAL,2017-06-13,ACTUAL,2017-06-13,2023-06,2023-06-30,2023-06-29,ACTUAL,2023-06-29,2020-02-16,ACTUAL,2020-02-16,,INTERVENTIONAL,PrE0505,,Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesothelioma,"Open Label, Phase II Study of Anti - Programmed Death - Ligand 1 Antibody, Durvalumab (MEDI4736), in Combination With Chemotherapy for the First-Line Treatment of Unresectable Mesothelioma",COMPLETED,,PHASE2,55.0,ACTUAL,"PrECOG, LLC.",,1.0,,,f,,,,t,t,f,,,,,,,,,NO,Data is proprietary.,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,OTHER,,,,,,,2023,1.0
NCT02975349,,2016-11-23,2021-01-13,2019-01-14,2024-04-22,2016-11-23,2016-11-29,ESTIMATED,2021-01-13,2021-02-05,ACTUAL,2019-01-14,2019-01-17,ACTUAL,2024-04-22,2024-04-26,ACTUAL,2017-03-07,ACTUAL,2017-03-07,2024-04,2024-04-30,2024-04-02,ACTUAL,2024-04-02,2018-01-24,ACTUAL,2018-01-24,,INTERVENTIONAL,,"Modified Intent-To-Treat (mITT) analysis set included participants who belong to both Intent To Treat (ITT, consisted all participants who randomly allocated to a treatment, based on the intention to treat as randomized principle) and safety analysis sets (consisted all participants who receive at least 1 dose of trial treatment), and who have at least one baseline and one post-baseline magnetic resonance imaging (MRI) assessment.",A Study of Efficacy and Safety of M2951 in Participants With Relapsing Multiple Sclerosis,"A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 With a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients With Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.",TERMINATED,,PHASE2,267.0,ACTUAL,EMD Serono,Reported p values are not adjusted for multiple testing.,6.0,,Results from the EVOLUTION clinical trials showed evobrutinib did not meet its primary endpoint of annualized relapse rate for up to 156 weeks compared to oral teriflunomide in both studies.,f,,,,t,t,f,,,,,,"Within six months after the occurrence of an approval of a new product or a new indication for an approved product in both the European Union and the United States after January 1, 2014 If approval of a product is not sought, Merck shall make publicly available such data within eighteen months after the trial completion date. Data will not be shared for products and indications approved prior to January 1, 2014",Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researcher qualifications and legitimacy of the research purpose.,https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html,YES,"Per company policy and with respect to the principles set forth by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Pharmaceutical Research and Manufacturers of America (PhRMA), the Declaration of Helsinki, and applicable laws and regulations , we inform the public about the designs and results of our clinical trials in a timely and balanced manner, regardless of the outcome. We are committed to enhancing public health through responsible sharing of clinical trial data in a manner that is consistent with: safeguarding the privacy of patients; respecting the integrity of national regulatory systems; and maintaining incentives for investment in biomedical research.",2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,INDUSTRY,,,,,,,2024,0.0
NCT03818607,,2019-01-17,2023-03-23,,2023-04-27,2019-01-24,2019-01-28,ACTUAL,2023-04-27,2023-05-23,ACTUAL,,,,2023-04-27,2023-05-23,ACTUAL,2019-01-22,ACTUAL,2019-01-22,2023-04,2023-04-30,2022-07-12,ACTUAL,2022-07-12,2022-07-12,ACTUAL,2022-07-12,,INTERVENTIONAL,DAHLIA,,A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH,"A Randomized, Double-Blind, Active-Controlled Phase 3 Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)",COMPLETED,,PHASE3,42.0,ACTUAL,Amgen,,2.0,,,f,,,,t,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,INDUSTRY,,,,,,,2022,1.0
NCT04816071,,2021-03-23,,,2024-08-29,2021-03-23,2021-03-25,ACTUAL,,,,,,,2024-08-29,2024-09-03,ACTUAL,2021-05-01,ACTUAL,2021-05-01,2021-05,2021-05-31,2021-05-01,ACTUAL,2021-05-01,2021-05-01,ACTUAL,2021-05-01,,INTERVENTIONAL,,,Essential Amino Acid Supplementation in Older Adult COVID-19 Patients,Essential Amino Acid Supplementation in Older Adult COVID-19 Patients,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,University of Arkansas,,4.0,,PI no longer wanted to do the study,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,OTHER,,,,,,,2021,0.0
NCT05720052,,2023-01-11,,,2024-07-16,2023-02-06,2023-02-09,ACTUAL,,,,,,,2024-07-16,2024-07-18,ACTUAL,2023-02-06,ACTUAL,2023-02-06,2024-07,2024-07-31,2023-11-28,ACTUAL,2023-11-28,2023-11-28,ACTUAL,2023-11-28,,INTERVENTIONAL,,,A Study of MS-553 in Patients With Relapsed or Refractory B-cell Lymphoma,A Phase I/II Study to Evaluate the Safety and Efficacy of the MS-553 in Patients With Relapsed or Refractory B-cell Lymphoma,TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,"MingSight Pharmaceuticals, Inc",,1.0,,The study is terminated due to major protocol revisions.,f,,,,t,f,f,,,,,,,,,,,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,INDUSTRY,,,,,,,2023,0.0
NCT02922816,,2016-09-27,,,2023-11-11,2016-10-03,2016-10-04,ESTIMATED,,,,,,,2023-11-11,2023-11-15,ACTUAL,2016-12-01,ACTUAL,2016-12-01,2023-11,2023-11-30,2021-12-03,ACTUAL,2021-12-03,2021-12-03,ACTUAL,2021-12-03,,INTERVENTIONAL,PREMIX,,FMT for MDRO Colonization After Infection in Renal Transplant Recipients,A Pilot Study Using Fecal Microbiota Transplant in Renal Transplant Recipients to Eliminate Multidrug-Resistant Organism Colonization After Infection and Examine Gastrointestinal Carriage in a Randomized Placebo-Controlled Design,TERMINATED,,PHASE1,11.0,ACTUAL,Emory University,,2.0,,This study was paused and was not resumed due to the COVID-19 pandemic.,f,,,,t,t,f,,,,,,,Researchers interested in using data collected in this study should submit a methodologically sound protocol to the study PI.,,YES,De-identified sequencing data may be made available to outside collaborators upon request and approval by study team.,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,OTHER,,,,,,,2021,0.0
NCT03281876,,2017-09-05,2020-11-17,,2021-01-08,2017-09-11,2017-09-13,ACTUAL,2021-01-08,2021-01-11,ACTUAL,,,,2021-01-08,2021-01-11,ACTUAL,2017-11-27,ACTUAL,2017-11-27,2021-01,2021-01-31,2020-03-26,ACTUAL,2020-03-26,2020-03-26,ACTUAL,2020-03-26,,INTERVENTIONAL,,,A Study to Test if the Vaccine is Working Well in Chronic Obstructive Pulmonary Disease (COPD) Patients Aged 40 to 80 Years Old to Reduce Episodes of Worsening Symptoms and to Gather Further Information on Safety and Immune Response.,"An Observer-blind Study to Evaluate the Efficacy, Safety, Reactogenicity and Immunogenicity of the GSK Biologicals' Investigational Vaccine GSK3277511A When Administered to COPD Patients",COMPLETED,,PHASE2,606.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,f,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",https://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,INDUSTRY,,,,,,,2020,1.0
NCT04368364,,2020-04-24,2022-03-22,,2022-05-12,2020-04-28,2020-04-29,ACTUAL,2022-05-12,2022-05-16,ACTUAL,,,,2022-05-12,2022-05-16,ACTUAL,2020-05-22,ACTUAL,2020-05-22,2022-05,2022-05-31,2020-06-29,ACTUAL,2020-06-29,2020-06-29,ACTUAL,2020-06-29,,INTERVENTIONAL,,,A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks (QLB)vs Intrathecal Morphine(ITM) for Post Cesarean Section Pain,A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks vs Intrathecal Morphine for Post Cesarean Section Pain,TERMINATED,,PHASE4,3.0,ACTUAL,"The University of Texas Health Science Center, Houston",,3.0,,Study was stopped early due to a conflicting study in the same patient population at the study location.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,OTHER,,,,,,,2020,0.0
NCT03537131,,2018-04-25,,,2022-05-17,2018-05-14,2018-05-25,ACTUAL,,,,,,,2022-05-17,2022-05-18,ACTUAL,2018-06-02,ACTUAL,2018-06-02,2020-11,2020-11-30,2021-07-14,ACTUAL,2021-07-14,2021-07-14,ACTUAL,2021-07-14,,INTERVENTIONAL,DEPTH,,Dapagliflozin During Exercise for the PrevenTion of Hypoglycaemia,Dapagliflozin During Exercise for the Prevention of Hypoglycaemia in Type 1 Diabetes,TERMINATED,,PHASE2,9.0,ACTUAL,University of Oxford,,2.0,,Temporary halt due to COVID-19 pandemic,f,,,,t,f,f,,,,,,,,,YES,,2024-10-16 20:03:09.740742,2024-10-16 20:03:09.740742,OTHER,,,,,,,2021,0.0
NCT02332590,,2015-01-05,2017-05-24,2016-12-07,2022-03-15,2015-01-05,2015-01-07,ESTIMATED,2017-07-24,2017-07-25,ACTUAL,2016-12-07,2016-12-08,ESTIMATED,2022-03-15,2022-03-28,ACTUAL,2015-01-28,ACTUAL,2015-01-28,2022-03,2022-03-31,2020-12-29,ACTUAL,2020-12-29,2016-01-20,ACTUAL,2016-01-20,,INTERVENTIONAL,,Analysis was performed on randomized population that included all participants who received at least 1 dose or part of a dose of Investigational Medicinal Product (IMP).,Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH),"A Randomized, Double-blind, Parallel-group Study Assessing the Efficacy and Safety of Sarilumab Monotherapy Versus Adalimumab Monotherapy in Patients With Rheumatoid Arthritis",COMPLETED,,PHASE3,369.0,ACTUAL,Sanofi,,2.0,,,f,,,,t,,,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,INDUSTRY,,,,,,,2020,1.0
NCT02892149,,2016-09-02,2022-04-25,2021-01-22,2022-06-07,2016-09-02,2016-09-08,ESTIMATED,2022-06-07,2022-06-28,ACTUAL,2021-01-22,2021-01-26,ACTUAL,2022-06-07,2022-06-28,ACTUAL,2016-08,ACTUAL,2016-08-31,2022-06,2022-06-30,2020-03-30,ACTUAL,2020-03-30,2020-01-16,ACTUAL,2020-01-16,,INTERVENTIONAL,,,Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD),"Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE-CONVERSION)",COMPLETED,,PHASE3,3554.0,ACTUAL,Akebia Therapeutics,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,INDUSTRY,,,,,,,2020,1.0
NCT03150056,,2017-05-09,2021-07-29,,2022-08-09,2017-05-09,2017-05-11,ACTUAL,2021-07-29,2021-08-26,ACTUAL,,,,2022-08-09,2022-08-10,ACTUAL,2017-07-18,ACTUAL,2017-07-18,2022-08,2022-08-31,2021-06-22,ACTUAL,2021-06-22,2020-07-31,ACTUAL,2020-07-31,,INTERVENTIONAL,,,Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer,"A Phase IB Open-label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Combination With Androgen Deprivation Therapy and Other Agents in Subjects With Castrate-resistant Prostate Cancer (CRPC)",TERMINATED,,PHASE1,73.0,ACTUAL,GlaxoSmithKline,,2.0,,This study has been terminated due to meeting protocol defined futility.,f,,,,f,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,INDUSTRY,,,,,,,2021,0.0
NCT04572893,,2020-09-09,,,2024-03-26,2020-09-29,2020-10-01,ACTUAL,,,,,,,2024-03-26,2024-03-27,ACTUAL,2020-08-04,ACTUAL,2020-08-04,2024-03,2024-03-31,2024-02-22,ACTUAL,2024-02-22,2024-02-22,ACTUAL,2024-02-22,,INTERVENTIONAL,,,Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities,"An Open-Label, Exploratory Study of the Safety and Preliminary Efficacy of Danicamtiv in Stable Ambulatory Participants With Primary Dilated Cardiomyopathy Due to Either MYH7 or TTN Variants or Other Causalities",TERMINATED,,PHASE2,41.0,ACTUAL,Bristol-Myers Squibb,,1.0,,Business objectives have changed,f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,INDUSTRY,,,,,,,2024,0.0
NCT04542499,,2020-09-02,,,2024-04-12,2020-09-02,2020-09-09,ACTUAL,,,,,,,2024-04-12,2024-04-15,ACTUAL,2020-10-27,ACTUAL,2020-10-27,2024-04,2024-04-30,2024-02-15,ACTUAL,2024-02-15,2024-01-29,ACTUAL,2024-01-29,,INTERVENTIONAL,TEMPO-3,,"Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations","A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial)",COMPLETED,,PHASE3,507.0,ACTUAL,"Cerevel Therapeutics, LLC",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,INDUSTRY,,,,,,,2024,1.0
NCT03985462,,2019-06-01,,,2020-10-13,2019-06-12,2019-06-13,ACTUAL,,,,,,,2020-10-13,2020-10-19,ACTUAL,2019-07-03,ACTUAL,2019-07-03,2020-05,2020-05-31,2020-06-30,ACTUAL,2020-06-30,2020-05-30,ACTUAL,2020-05-30,,INTERVENTIONAL,,,Very Small Embryonic-like Stem Cells for Ovary,Autologous Very Small Embryonic-like Stem Cells(VSELs) for Premature Ovarian Failure,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Fuda Cancer Hospital, Guangzhou",,4.0,,Policy changes have contributed to the failure to carry out smoothly,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,OTHER,,,,,,,2020,0.0
NCT03645096,,2018-08-22,2023-08-24,,2024-04-25,2018-08-22,2018-08-24,ACTUAL,2024-04-25,2024-05-01,ACTUAL,,,,2024-04-25,2024-05-01,ACTUAL,2019-09-01,ACTUAL,2019-09-01,2024-04,2024-04-30,2022-05-31,ACTUAL,2022-05-31,2022-05-31,ACTUAL,2022-05-31,,INTERVENTIONAL,,The overall number of baseline participants does not differ from the number of participants randomized.,Development of Pregnenolone as a Treatment for Depression,NCCIH Development of Pregnenolone as a Treatment for Depression R61 Phase,COMPLETED,,PHASE1,34.0,ACTUAL,University of Texas Southwestern Medical Center,Some fMRI data may have been excluded as a result of motion in the MRI machine.,6.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,OTHER,,,,,,,2022,1.0
NCT02819843,,2016-06-28,,,2024-04-09,2016-06-28,2016-06-30,ESTIMATED,,,,,,,2024-04-09,2024-04-11,ACTUAL,2016-06-21,ACTUAL,2016-06-21,2024-04,2024-04-30,2024-02-22,ACTUAL,2024-02-22,2024-02-22,ACTUAL,2024-02-22,,INTERVENTIONAL,,,"A Study of T-VEC (Talimogene Laherparepvec) With or Without Radiotherapy for Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors","A Phase II Randomized Trial of Intralesional Talimogene Laherparepvec (TALIMOGENE LAHERPAREPVEC) With or Without Radiotherapy for Cutaneous Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors",COMPLETED,,PHASE2,19.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,OTHER,,,,,,,2024,0.0
NCT03985943,,2019-06-11,2024-06-21,,2024-08-09,2019-06-11,2019-06-14,ACTUAL,2024-08-09,2024-08-14,ACTUAL,,,,2024-08-09,2024-08-14,ACTUAL,2019-06-27,ACTUAL,2019-06-27,2024-08,2024-08-31,2022-08-11,ACTUAL,2022-08-11,2021-12-29,ACTUAL,2021-12-29,,INTERVENTIONAL,,The ITT population consisted of all randomized participants.,Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis,"A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis",COMPLETED,,PHASE3,941.0,ACTUAL,Galderma R&D,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,INDUSTRY,,,,,,,2022,1.0
NCT04254692,,2019-12-23,2024-06-20,,2024-07-16,2020-02-03,2020-02-05,ACTUAL,2024-07-16,2024-08-07,ACTUAL,,,,2024-07-16,2024-08-07,ACTUAL,2021-01-05,ACTUAL,2021-01-05,2024-07,2024-07-31,2021-01-21,ACTUAL,2021-01-21,2021-01-21,ACTUAL,2021-01-21,,INTERVENTIONAL,,,Optimizing Recovery in Abdominoplasty,Randomized Controlled Trial Evaluating Liposomal Bupivacaine Following Abdominoplasty,TERMINATED,,PHASE4,2.0,ACTUAL,"University of Wisconsin, Madison","study terminated early, not powered for meaningful results",2.0,,division wide research suspension,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,OTHER,,,,,,,2021,0.0
NCT04238091,,2020-01-14,,,2022-03-04,2020-01-21,2020-01-23,ACTUAL,,,,,,,2022-03-04,2022-03-21,ACTUAL,2019-12-19,ACTUAL,2019-12-19,2022-03,2022-03-31,2022-03-02,ACTUAL,2022-03-02,2022-03-02,ACTUAL,2022-03-02,,INTERVENTIONAL,,,Clinical Trial to Evaluate the Efficacy of Fecal Microbiota Transplantation in Patients With Alopecia Areata,Open Label Clinical Trial to Evaluate the Efficacy of Fecal Microbiota Transplantation in Patients With Alopecia Areata,WITHDRAWN,,PHASE2,0.0,ACTUAL,Columbia University,,2.0,,Investigator is no longer interested in moving forward with this study,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,OTHER,,,,,,,2022,0.0
NCT05524857,,2022-08-30,,,2024-04-19,2022-08-30,2022-09-01,ACTUAL,,,,,,,2024-04-19,2024-04-23,ACTUAL,2022-01-28,ACTUAL,2022-01-28,2024-04,2024-04-30,2024-04-09,ACTUAL,2024-04-09,2024-04-09,ACTUAL,2024-04-09,,INTERVENTIONAL,,,Combination of Fedratinib and Decitabine for Myeloproliferative Neoplasms (MPN)- Accelerated Phase (AP)/Blast Phase (BP),Phase I Trial of Fedratinib in Combination With Decitabine in Patients With Myeloproliferative Neoplasms in Accelerated and Blast Phase,TERMINATED,,PHASE1,2.0,ACTUAL,Columbia University,,2.0,,Closed by Sponsor,f,,,,t,t,f,,,f,,,,,,,,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,OTHER,,,,,,,2024,0.0
NCT04650217,,2020-11-17,2022-11-21,,2023-01-18,2020-11-30,2020-12-02,ACTUAL,2023-01-18,2023-02-02,ACTUAL,,,,2023-01-18,2023-02-02,ACTUAL,2021-10-07,ACTUAL,2021-10-07,2023-01,2023-01-31,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,1 participant signed consent for the study but was never randomized into a study group,Levodopa and Exercise for Older Adults With Depression and Psychomotor Slowing,Combination Treatment With L-DOPA and Exercise for Mood and Mobility Problems in Late-Life,TERMINATED,,PHASE4,1.0,ACTUAL,New York State Psychiatric Institute,,4.0,,Study terminated by sponsor (NIMH),f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,OTHER,,,,,,,2021,0.0
NCT04535817,,2020-08-13,,,2021-08-11,2020-08-27,2020-09-02,ACTUAL,,,,,,,2021-08-11,2021-08-18,ACTUAL,2021-01-01,ESTIMATED,2021-01-01,2021-08,2021-08-31,2022-01-01,ESTIMATED,2022-01-01,2022-01-01,ESTIMATED,2022-01-01,,INTERVENTIONAL,,,Xolair Interventional Study in ASD Patients With Comorbid Atopy,The Effect of Omalizumab (Xolair) on Improving Neuropsychiatric Symptoms in a Subset of ASD Patients With Atopic Disease and Elevated Total IgE Levels,WITHDRAWN,,PHASE1,0.0,ACTUAL,Beth Israel Deaconess Medical Center,,1.0,,We are terminating due to loss of funding because of Covid-19.,f,,,,t,t,f,,,t,,,,,,NO,There is no plan to share data with researchers not directly involved in this study and on the research team.,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,OTHER,,,,,,,2022,0.0
NCT04493541,,2020-07-28,,,2023-05-08,2020-07-28,2020-07-30,ACTUAL,,,,,,,2023-05-08,2023-05-09,ACTUAL,2020-08-26,ACTUAL,2020-08-26,2023-05,2023-05-31,2023-04-21,ACTUAL,2023-04-21,2023-04-21,ACTUAL,2023-04-21,,INTERVENTIONAL,,,A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus,"A Phase 1b Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus",COMPLETED,,PHASE1,13.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,INDUSTRY,,,,,,,2023,1.0
NCT03213158,,2017-04-26,2022-03-18,,2022-05-11,2017-07-06,2017-07-11,ACTUAL,2022-04-15,2022-05-11,ACTUAL,,,,2022-05-11,2022-06-01,ACTUAL,2017-09-15,ACTUAL,2017-09-15,2022-05,2022-05-31,2021-04-16,ACTUAL,2021-04-16,2021-04-16,ACTUAL,2021-04-16,,INTERVENTIONAL,IXADES,,Ixazomib for Desensitization,Ixazomib for Desensitization in Kidney Transplantation,COMPLETED,,PHASE2,10.0,ACTUAL,"University of Wisconsin, Madison",,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,OTHER,,,,,,,2021,0.0
NCT04941183,,2021-05-04,,,2024-01-18,2021-06-24,2021-06-28,ACTUAL,,,,,,,2024-01-18,2024-01-19,ACTUAL,2021-04-14,ACTUAL,2021-04-14,2024-01,2024-01-31,2023-06-06,ACTUAL,2023-06-06,2022-12-12,ACTUAL,2022-12-12,,INTERVENTIONAL,,,"Phase 1 Study to Assess Safety, Tolerability, PD, PK, Immunogenicity of IV NTR-441 Solution in Healthy Volunteers and COVID-19 Patients","A Randomized, Placebo-controlled, Double-blind, Single-ascending-dose and Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of IV NTR-441 Solution in HV Adults and COVID-19 Patients",TERMINATED,,PHASE1,52.0,ACTUAL,Neutrolis,,2.0,,the emergence of the omicron variant of COVID-19 lead to insufficient enrollment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,INDUSTRY,,,,,,,2023,0.0
NCT02591654,,2015-10-21,,,2022-12-28,2015-10-28,2015-10-29,ESTIMATED,,,,,,,2022-12-28,2022-12-30,ACTUAL,2015-10,ACTUAL,2015-10-31,2022-12,2022-12-31,2022-10,ACTUAL,2022-10-31,2022-10,ACTUAL,2022-10-31,,INTERVENTIONAL,MPAK,,MRI and PET to Assess Pembrolizumab Response,A Feasibility Study of MRI and PET Imaging to Assess Response to MK-3475 (Pembrolizumab) in Patients With Metastatic Melanoma,TERMINATED,,EARLY_PHASE1,6.0,ACTUAL,Columbia University,,1.0,,Poor enrollment,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,OTHER,,,,,,,2022,0.0
NCT05262517,,2022-02-21,2024-04-12,,2024-05-07,2022-02-21,2022-03-02,ACTUAL,2024-05-07,2024-05-16,ACTUAL,,,,2024-05-07,2024-05-16,ACTUAL,2022-05-05,ACTUAL,2022-05-05,2024-04,2024-04-30,2023-05-18,ACTUAL,2023-05-18,2023-05-18,ACTUAL,2023-05-18,,INTERVENTIONAL,,Analysis population included participants who were enrolled and received at least 1 dose of study medication. Baseline characteristics tabulated by the treated analysis set.,Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for Acute Treatment of Temporomandibular Disorders,"A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Temporomandibular Disorders (TMD)",TERMINATED,,PHASE3,126.0,ACTUAL,Pfizer,,2.0,,Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.,,,,,,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,INDUSTRY,,,,,,,2023,0.0
NCT02289300,,2014-11-07,,,2020-01-10,2014-11-10,2014-11-13,ESTIMATED,,,,,,,2020-01-10,2020-01-13,ACTUAL,2020-01,ESTIMATED,2020-01-31,2020-01,2020-01-31,2021-12,ESTIMATED,2021-12-31,2021-01,ESTIMATED,2021-01-31,,INTERVENTIONAL,,,"A Study to Evaluate a Study Drug, DCB-BO1202, for Alleviating Liver Fibrosis in Liver Cancer Patients","A Phase II Randomized, Double-Blind, Placebo Controlled, Parallel Study of DCB-BO1202 for Alleviating Liver Fibrosis in HBV Patients With Intermediate Hepatocellular Carcinoma Receiving Loco-regional Therapies",WITHDRAWN,,PHASE2,0.0,ACTUAL,A2 Healthcare Taiwan Corporation,,3.0,,At sponsor's discretion,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,INDUSTRY,,,,,,,2021,0.0
NCT04402866,,2020-05-22,2022-02-25,,2022-03-15,2020-05-22,2020-05-27,ACTUAL,2022-03-15,2022-03-17,ACTUAL,,,,2022-03-15,2022-03-17,ACTUAL,2020-06-24,ACTUAL,2020-06-24,2022-03,2022-03-31,2021-04-21,ACTUAL,2021-04-21,2021-04-21,ACTUAL,2021-04-21,,INTERVENTIONAL,,Part 1: Safety analysis set - all participants who received at least one dose of study drug.~Part 2: Intent-to-Treat (ITT) analysis set - all participants who were randomized into the study.,TD-0903 for ALI Associated With COVID-19,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-center Study of an Inhaled Pan-Janus Kinase Inhibitor, TD-0903, to Treat Symptomatic Acute Lung Injury Associated With COVID-19",COMPLETED,,PHASE2,235.0,ACTUAL,Theravance Biopharma,,6.0,,,f,,,,f,t,f,,,f,,,,,,NO,"Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.",2024-10-15 13:25:33.233915,2024-10-15 13:25:33.233915,INDUSTRY,,,,,,,2021,1.0
NCT03717012,,2018-10-19,2021-03-25,,2021-05-14,2018-10-22,2018-10-23,ACTUAL,2021-05-14,2021-06-09,ACTUAL,,,,2021-05-14,2021-06-09,ACTUAL,2018-11-15,ACTUAL,2018-11-15,2021-05,2021-05-31,2020-06-10,ACTUAL,2020-06-10,2020-03-27,ACTUAL,2020-03-27,,INTERVENTIONAL,,"Randomized set (RS): This patient set includes all randomized patients, whether treated with pulmonary rehabilitation or not.",Study of Pulmonary Rehabilitation in Patients With Idiopathic Pulmonary Fibrosis (IPF),"Study of Pulmonary Rehabilitation In Nintedanib Treated Patients With IPF: Improvements in Activity, Exercise Endurance Time, and QoL",TERMINATED,,PHASE4,19.0,ACTUAL,Boehringer Ingelheim,Trial was terminated prematurely due to difficulties with recruitment and a global BI recruitment hold implemented on 17 March 2020 because of the COVID-19 pandemic. The recruitment rate was slow and the target number of participants to be recruited was not reached. No inferential statistical analysis was performed.,2.0,,The trial was terminated prematurely due to difficulties with recruitment because of the COVID-19 pandemic.,t,,,,f,t,f,,,,,,,,,UNDECIDED,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:~1. find information in order to request access to clinical study data, for listed studies.~2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'.",2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,INDUSTRY,,NCT03843892,APPROVED_FOR_MARKETING,,,,2020,0.0
NCT04492254,,2020-07-22,,,2022-04-26,2020-07-29,2020-07-30,ACTUAL,,,,,,,2022-04-26,2022-05-02,ACTUAL,2020-10-27,ACTUAL,2020-10-27,2022-04,2022-04-30,2021-11-29,ACTUAL,2021-11-29,2021-11-29,ACTUAL,2021-11-29,,INTERVENTIONAL,ETHIC,,Early Prophylactic Low-molecular-weight Heparin (LMWH) in Symptomatic COVID-19 Positive Patients,"Early Thromboprophylaxis in COVID-19 (ETHIC Trial): an Open Label, Randomized Phase IIIb Trial of Community-based (LMWH) Versus Standard of Care (no Enoxaparin) in COVID-19 Positive Patients",TERMINATED,,PHASE3,219.0,ACTUAL,Thrombosis Research Institute,,2.0,,"Average event rate (end point) was much lower than expected. A larger sample size would have been required to maintain same statistical power, which was not achievable in a feasible time scale. No safety concerns were identified with bleeding.",f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,OTHER,,,,,,,2021,0.0
NCT03316573,,2017-10-18,2023-08-29,,2024-02-14,2017-10-18,2017-10-20,ACTUAL,2023-11-01,2023-11-22,ACTUAL,,,,2024-02-14,2024-02-16,ACTUAL,2017-12-07,ACTUAL,2017-12-07,2024-02,2024-02-29,2024-08-18,ESTIMATED,2024-08-18,2022-08-18,ACTUAL,2022-08-18,,INTERVENTIONAL,,,Pembrolizumab in Neoplasms or Lymphomas,A Phase 2 Study of Pembrolizumab in Patients With Histiocyte/Dendritic Cell Neoplasms and Biologically Selected Subtypes of Relapsed/Refractory Aggressive Lymphomas,SUSPENDED,,PHASE2,18.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,Low accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:19:02.699832,2024-10-14 23:19:02.699832,OTHER,,,,,,,2024,0.0
NCT04656704,,2020-11-30,,,2021-01-12,2020-12-04,2020-12-07,ACTUAL,,,,,,,2021-01-12,2021-01-14,ACTUAL,2020-01-01,ESTIMATED,2020-01-01,2021-01,2021-01-31,2022-01-01,ESTIMATED,2022-01-01,2022-01-01,ESTIMATED,2022-01-01,,INTERVENTIONAL,,,Hyaluronidase in Treating Oral Microstomia in Patients With Sclerosing Skin Disease,Investigating Hyaluronidase in Treating Oral Microstomia in Patients With Sclerosing Skin Disease,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Brigham and Women's Hospital,,1.0,,PI no longer pursuing clinical trial,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,OTHER,,,,,,,2022,0.0
NCT01071941,,2010-01-13,,,2024-06-15,2010-02-18,2010-02-19,ESTIMATED,,,,,,,2024-06-15,2024-06-18,ACTUAL,2010-10,ACTUAL,2010-10-31,2024-06,2024-06-30,2024-06,ACTUAL,2024-06-30,2024-06,ACTUAL,2024-06-30,,INTERVENTIONAL,,,rRp450-Phase I Trial in Liver Metastases and Primary Liver Tumors,rRp450-Phase I Trial in Liver Metastases and Primary Liver Tumors,TERMINATED,,PHASE1,15.0,ACTUAL,Massachusetts General Hospital,,1.0,,Inadequate funding,f,,,,t,,,,,,,,,,,,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,OTHER,,,,,,,2024,0.0
NCT03348163,,2017-11-08,2022-07-29,2022-01-24,2022-09-01,2017-11-15,2017-11-20,ACTUAL,2022-09-01,2022-10-03,ACTUAL,2022-09-01,2022-10-03,ACTUAL,2022-09-01,2022-10-03,ACTUAL,2018-06-06,ACTUAL,2018-06-06,2022-09,2022-09-30,2020-12-15,ACTUAL,2020-12-15,2020-12-15,ACTUAL,2020-12-15,,INTERVENTIONAL,(mo)BETTA,,(mo)BETTA Trial in Transwomen for Optimization of ART,"Bictegravir, Emtricitabine and Tenofovir Alafenamide in Transwomen for Optimization of ART: The (mo)BETTA Trial",TERMINATED,,PHASE4,26.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,Lack of ability to recruit due to COVID-19 pandemic,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,OTHER,,,,,,,2020,0.0
NCT04041362,,2019-07-31,,,2020-02-18,2019-07-31,2019-08-01,ACTUAL,,,,,,,2020-02-18,2020-02-21,ACTUAL,2020-04,ESTIMATED,2020-04-30,2019-11,2019-11-30,2021-03,ESTIMATED,2021-03-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients,"A Phase II, Open-label, Controlled, Proof-of-concept Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients",WITHDRAWN,,PHASE2,0.0,ACTUAL,United BioPharma,,2.0,,The study will not be submitted to authority for IND application.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,INDUSTRY,,,,,,,2021,0.0
NCT05097651,,2021-10-05,,,2024-05-08,2021-10-15,2021-10-28,ACTUAL,,,,,,,2024-05-08,2024-05-10,ACTUAL,2021-04-01,ACTUAL,2021-04-01,2024-05,2024-05-31,2023-08-31,ACTUAL,2023-08-31,2023-08-31,ACTUAL,2023-08-31,,INTERVENTIONAL,,,CBD for Sleep in People With HIV,Pilot Trial of Cannabidiol (CBD) for Sleep Problems in People With HIV,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, San Diego",,2.0,,Difficulties enrolling eligible participants,f,,,,t,t,f,,,,,,"The data and biospecimens will become available following publication. Data and biospecimens will be stored indefinitely, however, if a research participant decides they no longer want their biospecimens to be used, all efforts will be made to stop any additional studies.",Investigators whose proposed use of the data and/or biospecimens has been approved by the HNRP-CMCR leadership. HNRP-CMCR leadership will ensure that a Data Use Agreement is signed by the requesting investigator.,https://www.cmcr.ucsd.edu/,YES,"Data and biospecimens collected in the course of this study will be stored in the joint HIV Neurobehavioral Research Center (HNRP) - Center for Medicinal Cannabis Research (CMCR) Data and Biospecimen Repositories for potential future use. De-identified data and biospecimens may be made available to investigators conducting institutional review board (IRB) approved research. Interested investigators will submit a request for data and/or biospecimens. HNRP-CMCR leadership will be responsible for determining who will have access to the data and biospecimens and will ensure that a Data Use Agreement is signed by the requesting investigator. The data and biospecimens will be stored indefinitely, however, if a research participant decides they no longer want their biospecimens to be used, all efforts will be made to stop any additional studies.",2024-10-14 23:24:26.396281,2024-10-14 23:24:26.396281,OTHER,,,,,,,2023,0.0
NCT03905655,,2019-04-04,2023-10-06,,2023-11-03,2019-04-04,2019-04-05,ACTUAL,2023-11-03,2023-11-07,ACTUAL,,,,2023-11-03,2023-11-07,ACTUAL,2019-10-22,ACTUAL,2019-10-22,2023-11,2023-11-30,2021-10-11,ACTUAL,2021-10-11,2021-03-10,ACTUAL,2021-03-10,,INTERVENTIONAL,,All subjects receiving at least one dose of study medication,Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B,"Randomized Double-Blind Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B Virologically Suppressed for at Least Twelve Months on Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide or Entecavir",COMPLETED,,PHASE2,51.0,ACTUAL,Romark Laboratories L.C.,This study was a pilot study with a small number of participants.,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,INDUSTRY,,,,,,,2021,1.0
NCT04347512,,2020-04-11,,,2020-06-02,2020-04-11,2020-04-15,ACTUAL,,,,,,,2020-06-02,2020-06-04,ACTUAL,2020-06-02,ACTUAL,2020-06-02,2020-06,2020-06-30,2020-06-02,ACTUAL,2020-06-02,2020-06-02,ACTUAL,2020-06-02,,INTERVENTIONAL,TEACHCOVID,,EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA,EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA,WITHDRAWN,,PHASE3,0.0,ACTUAL,"University Hospital, Strasbourg, France",,3.0,,"In view of the notices concerning hydroxychloroquine issued by the regulatory authorities, we withdraw the protocol",f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 23:24:26.396281,2024-10-14 23:24:26.396281,OTHER,,,,,,,2020,0.0
NCT04599972,,2020-10-19,2023-11-12,2023-01-01,2024-04-02,2020-10-22,2020-10-23,ACTUAL,2023-11-12,2023-11-28,ACTUAL,2023-01-04,2023-01-09,ACTUAL,2024-04-02,2024-04-04,ACTUAL,2020-10-26,ACTUAL,2020-10-26,2023-11,2023-11-30,2022-01-28,ACTUAL,2022-01-28,2022-01-21,ACTUAL,2022-01-21,,INTERVENTIONAL,NEAR-2,,An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2),"A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (the NEAR-2 Study: Near Eye-vision Acuity Restoration)",COMPLETED,,PHASE3,304.0,ACTUAL,Orasis Pharmaceuticals Ltd.,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,INDUSTRY,,,,,,,2022,1.0
NCT03992716,,2019-06-13,,,2020-10-09,2019-06-19,2019-06-20,ACTUAL,,,,,,,2020-10-09,2020-10-14,ACTUAL,2019-11-26,ACTUAL,2019-11-26,2020-10,2020-10-31,2020-03-24,ACTUAL,2020-03-24,2020-03-24,ACTUAL,2020-03-24,,INTERVENTIONAL,,,Reaching Protein Target With SmofKabiven® Extra Nitrogen vs Olimel N9E During the Early Phase of Acute Critical Illness,"Reaching Protein Target With SmofKabiven® Extra Nitrogen Versus Olimel N9E: A Prospective, Randomised, Active-controlled, Patient-blinded, Multicentre Clinical Trial During the Early Phase of Acute Critical Illness",TERMINATED,,PHASE4,7.0,ACTUAL,Fresenius Kabi,,2.0,,Study had to be put on hold after the outbreak of Covid-19 in the participating countries and was terminated in September 2020 since a date for re-starting was not foreseeable.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 23:24:26.396281,2024-10-14 23:24:26.396281,INDUSTRY,,,,,,,2020,0.0
NCT05295784,,2022-02-21,,,2024-05-08,2022-03-15,2022-03-25,ACTUAL,,,,,,,2024-05-08,2024-05-10,ACTUAL,2024-05-08,ACTUAL,2024-05-08,2024-04,2024-04-30,2024-05-08,ACTUAL,2024-05-08,2024-05-08,ACTUAL,2024-05-08,,INTERVENTIONAL,,,PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia,Pharmacokinetics (PK) and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Arkansas,,3.0,,Data no longer support this study,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-14 23:24:26.396281,2024-10-14 23:24:26.396281,OTHER,,,,,,,2024,0.0
NCT03688633,,2018-09-08,,,2021-11-12,2018-09-26,2018-09-28,ACTUAL,,,,,,,2021-11-12,2021-11-15,ACTUAL,2019-05-01,ACTUAL,2019-05-01,2021-09,2021-09-30,2021-05-27,ACTUAL,2021-05-27,2021-05-27,ACTUAL,2021-05-27,,INTERVENTIONAL,NEUPERSART,,Candesartan in Peripheral Neuropathy,"Pilot Study, Single-blind, Candesartan Versus Usual Care of Peripheral Neuropathy Development Induced by Vincristine (PNIV) in Patients Treated for Lymphoma B",TERMINATED,,PHASE2,9.0,ACTUAL,"University Hospital, Limoges",,2.0,,Patient Recruitment Failure,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,OTHER,,,,,,,2021,0.0
NCT03969719,,2019-05-28,2022-02-24,,2022-04-18,2019-05-28,2019-05-31,ACTUAL,2022-04-18,2022-05-11,ACTUAL,,,,2022-04-18,2022-05-11,ACTUAL,2019-07-18,ACTUAL,2019-07-18,2022-04,2022-04-30,2021-03-30,ACTUAL,2021-03-30,2021-03-02,ACTUAL,2021-03-02,,INTERVENTIONAL,,,A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus,"A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PARALLEL GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED DAILY FOR 16 WEEKS IN ADULTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE AND TYPE 2 DIABETES MELLITUS ON METFORMIN",COMPLETED,,PHASE2,164.0,ACTUAL,Pfizer,,3.0,,,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,INDUSTRY,,,,,,,2021,1.0
NCT03846193,,2019-02-13,,,2024-07-03,2019-02-15,2019-02-19,ACTUAL,,,,,,,2024-07-03,2024-07-08,ACTUAL,2018-12-17,ACTUAL,2018-12-17,2024-07,2024-07-31,2024-06-25,ACTUAL,2024-06-25,2024-06-25,ACTUAL,2024-06-25,,INTERVENTIONAL,,,FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD,"FOCUS: An Open Label First in Human Phase I/II Multicentre Study to Evaluate the Safety, Dose Response and Efficacy of GT005 Administered as a Single Subretinal Injection in Subjects With Macular Atrophy Due to AMD",TERMINATED,,PHASE1/PHASE2,56.0,ACTUAL,Gyroscope Therapeutics Limited,,7.0,,The study was terminated due to the interim analysis demonstrating lack of treatment efficacy,f,,,,t,t,t,,,f,,,,,,,,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,INDUSTRY,,,,,,,2024,0.0
NCT04075513,,2019-08-29,2022-09-13,,2022-10-19,2019-08-29,2019-08-30,ACTUAL,2022-10-19,2022-11-14,ACTUAL,,,,2022-10-19,2022-11-14,ACTUAL,2019-10-09,ACTUAL,2019-10-09,2022-10,2022-10-31,2021-09-16,ACTUAL,2021-09-16,2021-09-16,ACTUAL,2021-09-16,,INTERVENTIONAL,inRange,"Analysis was performed on intent-to-treat (ITT) population which included all randomized participants (who signed the informed consent form and were allocated to a treatment group before the first investigational medicinal product \[IMP\] administration and recorded in the IRT database), irrespective of the treatment actually received and were analyzed according to the treatment group allocated by randomization.",Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients,"A 12-week Randomized, Controlled Trial to Compare TOUJEO® and TRESIBA® in Terms of Glucose Values in Target Range and Variability During Continuous Glucose Monitoring in Patients With Type 1 Diabetes Mellitus",COMPLETED,,PHASE4,343.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-14 23:24:26.396281,2024-10-14 23:24:26.396281,INDUSTRY,,,,,,,2021,1.0
NCT02309645,,2014-10-02,2022-08-17,,2022-08-17,2014-12-03,2014-12-05,ESTIMATED,2022-08-17,2023-07-14,ACTUAL,,,,2022-08-17,2023-07-14,ACTUAL,2014-10-01,ACTUAL,2014-10-01,2022-08,2022-08-31,2021-09-17,ACTUAL,2021-09-17,2021-08-17,ACTUAL,2021-08-17,,INTERVENTIONAL,,The full analysis set (FAS) consisted of all randomized participants.,The Paediatric EVICEL® Neuro Study,A Prospective Randomized Controlled Study Evaluating the Safety and Efficacy of EVICEL® Used for Suture-Line Sealing in Dura-Mater Closure During Paediatric Neurosurgical Cranial Procedures,TERMINATED,,PHASE3,40.0,ACTUAL,"Ethicon, Inc.",,2.0,,Study completed the required elements (40 paediatric subjects) per regulatory requirement. The study enrolled 40/42 subjects. No safety signals were identified. No changes required to the statistical analysis as described in the protocol.,f,,,,f,,,,,,,,,,,YES,,2024-10-14 23:24:26.396281,2024-10-14 23:24:26.396281,INDUSTRY,,,,,,,2021,0.0
NCT03893019,,2019-03-06,,,2024-05-15,2019-03-25,2019-03-27,ACTUAL,,,,,,,2024-05-15,2024-05-16,ACTUAL,2019-03-08,ACTUAL,2019-03-08,2024-05,2024-05-31,2023-01-30,ACTUAL,2023-01-30,2023-01-30,ACTUAL,2023-01-30,,INTERVENTIONAL,,,MB-CART20.1 Melanoma,Multicenter Phase I Trial of MB-CART20.1 for the Treatment of Patients With Metastatic Melanoma,TERMINATED,,EARLY_PHASE1,9.0,ACTUAL,Miltenyi Biomedicine GmbH,,3.0,,The risk-benefit assessment was not as expected.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,INDUSTRY,,,,,,,2023,0.0
NCT05359081,,2022-04-27,,,2024-04-10,2022-04-27,2022-05-03,ACTUAL,,,,,,,2024-04-10,2024-04-12,ACTUAL,2022-05-16,ACTUAL,2022-05-16,2024-04,2024-04-30,2024-03-28,ACTUAL,2024-03-28,2024-03-21,ACTUAL,2024-03-21,,INTERVENTIONAL,,,A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan,"A 52-week, Open-label Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan",TERMINATED,,PHASE3,68.0,ACTUAL,"Sumitomo Pharma Co., Ltd.",,1.0,,Due to company business strategy,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-14 23:24:26.396281,2024-10-14 23:24:26.396281,INDUSTRY,,,,,,,2024,0.0
NCT04230122,,2020-01-14,2021-08-04,,2021-11-03,2020-01-14,2020-01-18,ACTUAL,2021-11-03,2021-12-06,ACTUAL,,,,2021-11-03,2021-12-06,ACTUAL,2020-02-17,ACTUAL,2020-02-17,2021-11,2021-11-30,2020-06-04,ACTUAL,2020-06-04,2020-06-04,ACTUAL,2020-06-04,,INTERVENTIONAL,,All randomized participants.,A Study of LY3478006 in Healthy Participants,"A Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY3478006 in Healthy Subjects",TERMINATED,,PHASE1,4.0,ACTUAL,Eli Lilly and Company,Cohort 2 through 7 were not explored as study was terminated early for safety reasons after Cohort 1.,4.0,,Protocol stopping criteria (safety) were met.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,INDUSTRY,,,,,,,2020,0.0
NCT03079297,,2017-03-04,2022-09-29,,2022-12-29,2017-03-13,2017-03-14,ACTUAL,2022-12-29,2023-01-26,ACTUAL,,,,2022-12-29,2023-01-26,ACTUAL,2017-03-09,ACTUAL,2017-03-09,2022-12,2022-12-31,2021-10-04,ACTUAL,2021-10-04,2021-10-04,ACTUAL,2021-10-04,,INTERVENTIONAL,,,Rapid Antidepressant Effects of Leucine,A Pilot Double-Blind Randomized Placebo-Controlled Crossover Study to Investigate Rapid Antidepressant Effects of Leucine,TERMINATED,,PHASE2,16.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,Covid-19,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,OTHER,,,,,,,2021,0.0
NCT03650413,,2018-08-16,2023-07-11,,2023-09-28,2018-08-24,2018-08-28,ACTUAL,2023-09-28,2023-09-29,ACTUAL,,,,2023-09-28,2023-09-29,ACTUAL,2019-01-14,ACTUAL,2019-01-14,2023-09,2023-09-30,2022-07-12,ACTUAL,2022-07-12,2022-07-12,ACTUAL,2022-07-12,,INTERVENTIONAL,,There was only 1 arm in this study. The protocol was written with this single group receiving treatment based upon remission status.,An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease,A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease,TERMINATED,,PHASE2,143.0,ACTUAL,"Genentech, Inc.",,1.0,,This study was terminated early by the Sponsor based on the interim analysis of Study GA39925 (NCT03558152) that showed low efficacy of UTTR1147A in ulcerative colitis. Development of the drug in this indication has been terminated.,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).~For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-14 23:24:26.396281,2024-10-14 23:24:26.396281,INDUSTRY,,,,,,,2022,0.0
NCT04639011,,2020-11-16,,,2022-11-18,2020-11-19,2020-11-20,ACTUAL,,,,,,,2022-11-18,2022-11-21,ACTUAL,2022-10,ESTIMATED,2022-10-31,2022-11,2022-11-30,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Duloxetine Tibial Plateau,Effects of Duloxetine on Postoperative Pain Control and Knee Rehabilitation After Open Reduction Internal Fixation of Tibial Plateau Fractures,WITHDRAWN,,PHASE4,0.0,ACTUAL,Boston Medical Center,,2.0,,Study was not conducted because funding was not obtained.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,OTHER,,,,,,,2023,0.0
NCT02898077,,2016-09-08,2021-06-10,,2022-05-19,2016-09-08,2016-09-13,ESTIMATED,2021-07-12,2021-08-03,ACTUAL,,,,2022-05-19,2022-06-14,ACTUAL,2017-03-02,ACTUAL,2017-03-02,2022-05,2022-05-31,2021-04-12,ACTUAL,2021-04-12,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,All randomized participants.,A Study of Paclitaxel With or Without Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Cancer,"A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine",COMPLETED,,PHASE3,440.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,INDUSTRY,,,,,,,2021,1.0
NCT04022876,,2019-07-12,,,2022-10-07,2019-07-15,2019-07-17,ACTUAL,,,,,,,2022-10-07,2022-10-10,ACTUAL,2019-09-03,ACTUAL,2019-09-03,2022-10,2022-10-31,2022-08-30,ACTUAL,2022-08-30,2022-07-30,ACTUAL,2022-07-30,,INTERVENTIONAL,,,A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection),"A Phase 1b Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, for the Prevention of Chemotherapy-induced Myelosuppression",TERMINATED,,PHASE1,35.0,ACTUAL,"Aileron Therapeutics, Inc.",,3.0,,With a favorable safety profile the difference between treatment groups for the primary composite endpoint was not sufficient to generate statistically significant results with the targeted sample size,f,,,,t,t,f,,,,,,,,,,,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,INDUSTRY,,,,,,,2022,0.0
NCT04574869,,2020-09-16,,,2022-01-20,2020-10-01,2020-10-05,ACTUAL,,,,,,,2022-01-20,2022-02-04,ACTUAL,2021-01,ESTIMATED,2021-01-31,2022-01,2022-01-31,2022-12,ESTIMATED,2022-12-31,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,A Study of RLS-0071 in Patients With Acute Lung Injury Due to COVID-19 Pneumonia in Early Respiratory Failure,"A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, PK, & PD of RLS-0071 in Patients With Acute Lung Injury Due to COVID-19 Pneumonia in Early Respiratory Failure",WITHDRAWN,,PHASE1,0.0,ACTUAL,"ReAlta Life Sciences, Inc.",,6.0,,Low probability of enrolling patients prior to expiry of study drug.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,INDUSTRY,,,,,,,2022,0.0
NCT02963766,,2016-11-10,2022-06-07,,2022-06-07,2016-11-10,2016-11-15,ESTIMATED,2022-06-07,2022-07-01,ACTUAL,,,,2022-06-07,2022-07-01,ACTUAL,2016-12-29,ACTUAL,2016-12-29,2022-06-01,2022-06-01,2022-01-12,ACTUAL,2022-01-12,2021-06-12,ACTUAL,2021-06-12,,INTERVENTIONAL,AWARD-PEDS,All randomized participants.,A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes,"A Randomized, Double-Blind Study With an Open-Label Extension Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Pediatric Patients With Type 2 Diabetes Mellitus (AWARD-PEDS: Assessment of Weekly AdministRation of LY2189265 in Diabetes-PEDiatric Study)",COMPLETED,,PHASE3,154.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,t,,,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://www.vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,INDUSTRY,,,,,,,2022,1.0
NCT03369444,,2017-09-13,2022-05-18,,2022-11-08,2017-12-05,2017-12-12,ACTUAL,2022-11-08,2022-12-02,ACTUAL,,,,2022-11-08,2022-12-02,ACTUAL,2017-12-05,ACTUAL,2017-12-05,2022-11,2022-11-30,2020-10-20,ACTUAL,2020-10-20,2020-10-20,ACTUAL,2020-10-20,,INTERVENTIONAL,FIX-GT,,A Factor IX Gene Therapy Study (FIX-GT),"A Phase I/II, Open Label, Multicentre, Ascending Single Dose, Safety Study of a Novel Adeno- Associated Viral Vector (FLT180a) in Patients With Haemophilia B",TERMINATED,,PHASE1/PHASE2,10.0,ACTUAL,"University College, London","Protocol defined number of participants (n=24) was not met, the terminal dose as specified in the protocol was not identified prior to early study termination.~The primary efficacy endpoints (FIX response at the terminal dose) could therefore not be detailed established. However the FIX response data (efficacy endpoint) for the 4 patients treated at the last studied dose level 1.3×10e\^12 vg/kg, have been presented instead.",4.0,,Terminated early due to challenges during the COVID-19 pandemic and a change in requirements of data to be submitted for marketing authorisation.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,OTHER,,,,,,,2020,0.0
NCT03774407,,2018-12-05,2022-01-07,,2022-08-25,2018-12-10,2018-12-13,ACTUAL,2022-08-25,2022-09-21,ACTUAL,,,,2022-08-25,2022-09-21,ACTUAL,2019-06-20,ACTUAL,2019-06-20,2022-08,2022-08-31,2020-11-29,ACTUAL,2020-11-29,2020-11-10,ACTUAL,2020-11-10,,INTERVENTIONAL,,,Vaginal Estriol in Multiple Sclerosis,Dual Benefits of Vaginal Estriol: Improved Urogenital Health and Re-myelination in Relapsing Remitting Multiple Sclerosis (RRMS),COMPLETED,,PHASE2/PHASE3,21.0,ACTUAL,Texas Tech University Health Sciences Center,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,OTHER,,,,,,,2020,1.0
NCT02422524,,2015-04-16,,,2024-07-25,2015-04-16,2015-04-21,ESTIMATED,,,,,,,2024-07-25,2024-07-26,ACTUAL,2017-12-11,ACTUAL,2017-12-11,2017-12-14,2017-12-14,2023-11-17,ACTUAL,2023-11-17,2023-08-26,ACTUAL,2023-08-26,,INTERVENTIONAL,,,Pretomanid in Adults With Hepatic Impairment,"A Phase I, Single Dose, Open-Label Study Comparing the Pharmacokinetics and Safety of Pretomanid in Subjects With Mild, Moderate, and Severe Hepatic Impairment to Matched, Non-Hepatically Impaired Subjects",TERMINATED,,PHASE1,14.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,4.0,,The TB hepatic pretomanid PK trial is closed to enrollment. There is no possibility of enrolling and completing the CSR before November 2024.,f,,,,,t,f,,,f,,,,,,,,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,NIH,,,,,,,2023,0.0
NCT03183596,,2017-06-07,,,2018-05-29,2017-06-08,2017-06-12,ACTUAL,,,,,,,2018-05-29,2018-05-31,ACTUAL,2019-12,ESTIMATED,2019-12-31,2018-05,2018-05-31,2024-01,ESTIMATED,2024-01-31,2020-08,ESTIMATED,2020-08-31,,INTERVENTIONAL,,,Optimal Injection Site for Serratus Anterior Plane Block in Reconstructive Breast Surgery,"Optimal Injection Site for Serratus Anterior Plane Block in Reconstructive Breast Surgery (Randomized, Pilot Study)",WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Alabama at Birmingham,,2.0,,Principal investigator determination,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,OTHER,,,,,,,2024,0.0
NCT03199144,,2017-06-20,,,2022-06-20,2017-06-22,2017-06-26,ACTUAL,,,,,,,2022-06-20,2022-06-23,ACTUAL,2017-04-20,ACTUAL,2017-04-20,2022-06,2022-06-30,2021-03-19,ACTUAL,2021-03-19,2021-03-19,ACTUAL,2021-03-19,,INTERVENTIONAL,CKPancreas,,Neoadjuvant Chemotherapy and Stereotactic Radiosurgery to Pancreatectomy for Patients With Borderline Resectable Pancreatic Cancer,Neoadjuvant Chemotherapy and Stereotactic Radiosurgery to Pancreatectomy for Borderline Resectable Pancreatic Cancer : Phase II Study,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Centre Francois Baclesse, Luxembourg",,1.0,,difficulties to recruit patients,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,OTHER,,,,,,,2021,0.0
NCT04537923,,2020-09-02,2023-10-10,,2023-10-10,2020-09-02,2020-09-03,ACTUAL,2023-10-10,2023-11-02,ACTUAL,,,,2023-10-10,2023-11-02,ACTUAL,2020-10-19,ACTUAL,2020-10-19,2023-10,2023-10-31,2022-11-01,ACTUAL,2022-11-01,2022-10-11,ACTUAL,2022-10-11,,INTERVENTIONAL,SURPASS-6,All randomized participants.,A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin,"A Randomized, Phase 3, Open-label Trial Comparing the Effect of the Addition of Tirzepatide Once Weekly Versus Insulin Lispro (U100) Three Times Daily in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin (SURPASS-6)",COMPLETED,,PHASE3,1428.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,INDUSTRY,,,,,,,2022,1.0
NCT03825718,,2019-01-22,,,2022-04-21,2019-01-30,2019-01-31,ACTUAL,,,,,,,2022-04-21,2022-04-28,ACTUAL,2019-01-17,ACTUAL,2019-01-17,2019-01,2019-01-31,2020-12-01,ACTUAL,2020-12-01,2020-09-01,ACTUAL,2020-09-01,,INTERVENTIONAL,,,A Study of GC007F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL,A Study of GC007F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL,COMPLETED,,EARLY_PHASE1,29.0,ACTUAL,Hebei Yanda Ludaopei Hospital,,1.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,OTHER,,,,,,,2020,1.0
NCT02483000,,2015-06-23,2020-09-29,,2020-10-30,2015-06-23,2015-06-26,ESTIMATED,2020-10-30,2020-11-23,ACTUAL,,,,2020-10-30,2020-11-23,ACTUAL,2017-02-01,ACTUAL,2017-02-01,2020-09,2020-09-30,2020-09-02,ACTUAL,2020-09-02,2019-11-17,ACTUAL,2019-11-17,,INTERVENTIONAL,,,Anti-CD20 Radioimmunotherapy Before Chemotherapy and Stem Cell Transplant in Treating Patients With High-Risk B-Cell Malignancies,Evaluation of Pretargeted Anti-CD20 Radioimmunotherapy Combined With BEAM Chemotherapy and Autologous Stem Cell Transplantation for High-Risk B-Cell Malignancies,TERMINATED,,PHASE1,3.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,Closed early due to lack of funding,f,,,,f,t,f,,,,,,,,,,,2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,OTHER,,,,,,,2020,0.0
NCT04145193,,2019-10-16,,,2020-09-17,2019-10-29,2019-10-30,ACTUAL,,,,,,,2020-09-17,2020-09-21,ACTUAL,2020-10-01,ESTIMATED,2020-10-01,2020-09,2020-09-30,2024-03-19,ESTIMATED,2024-03-19,2024-03-19,ESTIMATED,2024-03-19,,INTERVENTIONAL,,,Novel Oncology Therapies in Combination With Adjuvant Chemo in High-risk MSS-CRC,"A Phase 2, Open-label, Randomized, Multicenter, Platform Study of Novel Oncology Therapies in Combination With Adjuvant Chemotherapy in High-risk, Microsatellite-stable Colorectal Cancer (COLUMBIA-2)",WITHDRAWN,,PHASE2,0.0,ACTUAL,MedImmune LLC,,4.0,,Study withdrawn prior to enrollment due to changing standard of care landscape.,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-16 09:45:56.447778,2024-10-16 09:45:56.447778,INDUSTRY,,,,,,,2024,0.0
NCT02004782,,2013-11-25,,,2023-06-28,2013-12-03,2013-12-09,ESTIMATED,,,,,,,2023-06-28,2023-07-03,ACTUAL,2022-03,ESTIMATED,2022-03-31,2023-06,2023-06-30,2022-06,ESTIMATED,2022-06-30,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,BERST,,Barretts oEsophageal Resection With Steroid Therapy Trial,"Reduction in Symptomatic Oesophageal Stricture Formation Post-two Stage Complete Barrett's Excision for High Grade Dysplasia or Early Adenocarcinoma With Short-term Steroid Therapy: A Randomized, Doubleblind, Placebo-controlled, Multicentre Trial.",WITHDRAWN,,PHASE4,0.0,ACTUAL,Western Sydney Local Health District,,2.0,,study abandoned,f,,,,t,f,f,,,,,,,,,,,2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,OTHER,,,,,,,2022,0.0
NCT03907124,,2019-03-12,,,2023-09-18,2019-04-04,2019-04-08,ACTUAL,,,,,,,2023-09-18,2023-09-21,ACTUAL,2019-06-03,ACTUAL,2019-06-03,2023-09,2023-09-30,2021-07-09,ACTUAL,2021-07-09,2021-07-09,ACTUAL,2021-07-09,,INTERVENTIONAL,,,Clinical Utility of Pharmacogenomics of Psychotropic Medications,Clinical Utility of Pharmacogenomics of Psychotropic Medications,WITHDRAWN,,PHASE4,0.0,ACTUAL,Oregon Health and Science University,,2.0,,PI left institution prior to recruitment.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,OTHER,,,,,,,2021,0.0
NCT04880564,,2021-04-14,,,2022-10-20,2021-05-06,2021-05-10,ACTUAL,,,,,,,2022-10-20,2022-10-24,ACTUAL,2021-07-28,ACTUAL,2021-07-28,2022-10,2022-10-31,2022-09-30,ACTUAL,2022-09-30,2022-08-29,ACTUAL,2022-08-29,,INTERVENTIONAL,,,A Study of CN1 in Combination With CN401 in Adult Patients With Relapsed/Refractory Lymphoid Malignancies,"An Open-label, Multi-centre, Phase I/II Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of CN1 in Combination With CN401 in Adult Patients With Relapsed/Refractory Lymphoid Malignancies",TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,Curon Biopharmaceutical (Australia) Co Pty Ltd,,5.0,,Sponsor decided that there was no benefit in the drug treatment and due to company change in landscape in the new year.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,INDUSTRY,,,,,,,2022,0.0
NCT03484650,,2018-03-26,,,2021-01-27,2018-03-26,2018-04-02,ACTUAL,,,,,,,2021-01-27,2021-02-01,ACTUAL,2020-01-14,ACTUAL,2020-01-14,2021-01,2021-01-31,2022-12-01,ESTIMATED,2022-12-01,2022-12-01,ESTIMATED,2022-12-01,,INTERVENTIONAL,,,Systemic Lidocaine Infusion for Pain Control in Ventral Hernia,Systemic Lidocaine Infusion for Pain Control in Ventral Hernia,WITHDRAWN,,PHASE3,0.0,ACTUAL,Carilion Clinic,,2.0,,Lack of available resources to complete study,f,,,,f,t,f,,,f,,,,,,NO,No data to be shared.,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,OTHER,,,,,,,2022,0.0
NCT02910752,,2016-09-07,,,2021-11-23,2016-09-21,2016-09-22,ESTIMATED,,,,,,,2021-11-23,2021-11-26,ACTUAL,2016-09,,2016-09-30,2021-11,2021-11-30,2023-09,ESTIMATED,2023-09-30,2023-09,ESTIMATED,2023-09-30,,INTERVENTIONAL,,,CLAM Chemotherapy With PBSC Support for Relapsed Patients After Allogeneic Stem Cell Transplantation,"Salavge Chemotherapy With Cladribine, Cytarabine and Mitoxantrone Followed by Mobilized Peripheral Stem Cell Infusion From the Original Donor for Relapsed Patients After Allogeneic Stem Cell Transplantation: Phase I/II Study",SUSPENDED,,PHASE1/PHASE2,20.0,ESTIMATED,Shanghai Jiao Tong University School of Medicine,,1.0,,Low enrollment,f,,,,f,,,,,,,,,,,NO,,2024-10-14 23:24:26.396281,2024-10-14 23:24:26.396281,OTHER,,,,,,,2023,0.0
NCT03953612,,2019-04-24,2024-05-08,,2024-06-28,2019-05-14,2019-05-16,ACTUAL,2024-06-28,2024-07-03,ACTUAL,,,,2024-06-28,2024-07-03,ACTUAL,2019-03-12,ACTUAL,2019-03-12,2024-06,2024-06-30,2023-05-08,ACTUAL,2023-05-08,2023-05-08,ACTUAL,2023-05-08,,INTERVENTIONAL,,,"The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders","The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders",COMPLETED,,EARLY_PHASE1,58.0,ACTUAL,Yale University,,3.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,OTHER,,,,,,,2023,1.0
NCT02586155,,2015-10-21,2021-06-21,,2021-07-23,2015-10-22,2015-10-26,ESTIMATED,2021-07-23,2021-08-20,ACTUAL,,,,2021-07-23,2021-08-20,ACTUAL,2015-11,ACTUAL,2015-11-30,2021-07,2021-07-31,2021-06-21,ACTUAL,2021-06-21,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,BETonMACE,"Of the initial 1215 participants randomized into the High-Intensity statin therapy+RVX000222 group, 3 were randomized in error. Of the initial 1210 participants randomized into the High-Intensity statin therapy+placebo group, 4 were randomized in error.",Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD,"A Phase III Multi-Center, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Clinical Trial in High-Risk Type 2 Diabetes Mellitus (T2DM) Subjects With Coronary Artery Disease (CAD) to Determine Whether Bromodomain Extraterminal Domain (BET) Inhibition Treatment With RVX000222 Increases the Time to Major Adverse Cardiovascular Events (MACE)",COMPLETED,,PHASE3,2425.0,ACTUAL,Resverlogix Corp,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,INDUSTRY,,,,,,,2021,1.0
NCT05160168,,2021-11-22,2024-05-03,,2024-06-04,2021-12-03,2021-12-16,ACTUAL,2024-06-04,2024-06-05,ACTUAL,,,,2024-06-04,2024-06-05,ACTUAL,2022-01-03,ACTUAL,2022-01-03,2024-06,2024-06-30,2024-02-02,ACTUAL,2024-02-02,2024-02-02,ACTUAL,2024-02-02,,INTERVENTIONAL,,"No patients were enrolled in the Expansion cohorts, as the study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study.",A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST),"A Phase 1/2 Study of the Safety, Pharmacokinetics and Anti-Tumor Activity of the Oral KIT Inhibitor THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)",TERMINATED,,PHASE1/PHASE2,32.0,ACTUAL,Theseus Pharmaceuticals,"The Sponsor made a business decision to terminate the trial early due to observed dose limiting toxicities at dose levels that are below the target THE-630 exposure (set by preclinical studies) required for pan KIT variant inhibition in GIST patients. Therefore, several of the outcome measures could not be evaluated.",4.0,,The Sponsor terminated the study due to early dose-limiting toxicities.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 23:24:26.396281,2024-10-14 23:24:26.396281,INDUSTRY,,,,,,,2024,0.0
NCT04927247,,2021-05-26,,,2024-08-07,2021-06-10,2021-06-15,ACTUAL,,,,,,,2024-08-07,2024-08-09,ACTUAL,2021-12-09,ACTUAL,2021-12-09,2024-08,2024-08-31,2023-11-24,ACTUAL,2023-11-24,2023-11-24,ACTUAL,2023-11-24,,INTERVENTIONAL,,,A Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises,"A Randomized, Double-blind, Placebo-controlled, Multicenter Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises",TERMINATED,,PHASE3,72.0,ACTUAL,Pfizer,,2.0,,Study was terminated due to poor accrual and associated recrutiment challenges,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-14 23:24:26.396281,2024-10-14 23:24:26.396281,INDUSTRY,,,,,,,2023,0.0
NCT05870059,,2023-04-11,,,2023-05-19,2023-05-19,2023-05-23,ACTUAL,,,,,,,2023-05-19,2023-05-23,ACTUAL,2022-02-02,ACTUAL,2022-02-02,2023-05,2023-05-31,2022-11-16,ACTUAL,2022-11-16,2022-07-04,ACTUAL,2022-07-04,,INTERVENTIONAL,,,Comparative Evaluation of Propolis Mouthwash With 0.2% Chlorhexidine Mouthwash in Improving the Periodontitis,Comparative Evaluation of Propolis Mouthwash With 0.2% Chlorhexidine Mouthwash in Improving the Periodontitis,COMPLETED,,PHASE2,102.0,ACTUAL,Ziauddin University,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,it was written in the consent form that no information regarding patients will be shared to anyone in any case considering the ethics.,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,OTHER,,,,,,,2022,1.0
NCT04842630,,2021-04-01,,,2024-02-07,2021-04-12,2021-04-13,ACTUAL,,,,,,,2024-02-07,2024-02-09,ACTUAL,2021-04-08,ACTUAL,2021-04-08,2024-02,2024-02-29,2022-11-01,ACTUAL,2022-11-01,2022-11-01,ACTUAL,2022-11-01,,INTERVENTIONAL,,,A Phase 1 Dose Escalation and Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumors,"An Open-Label, Multicenter, Dose Escalation And Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies",TERMINATED,,PHASE1,11.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,1.0,,R\&d strategy adjustment,f,,,,,f,f,,,,,,,,,,,2024-10-14 23:24:26.396281,2024-10-14 23:24:26.396281,INDUSTRY,,,,,,,2022,0.0
NCT04186988,,2019-12-02,,,2022-01-24,2019-12-02,2019-12-05,ACTUAL,,,,,,,2022-01-24,2022-02-01,ACTUAL,2019-11-05,ACTUAL,2019-11-05,2022-01,2022-01-31,2020-03-12,ACTUAL,2020-03-12,2020-03-12,ACTUAL,2020-03-12,,INTERVENTIONAL,,,[18F]-AraG for the Detection of T-Cell Activation in Advanced Non-small Cell Lung Cancer Patients Undergoing PD-1/PD-L1-Directed Therapy,Imaging of T-Cell Activation With [18F]-AraG in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1-Directed Therapy,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,"University of California, Davis",,1.0,,Unable to recruit to study.,,,,,t,t,f,,,f,,,,,,,,2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,OTHER,,,,,,,2020,0.0
NCT04450004,,2020-06-18,,,2022-04-04,2020-06-25,2020-06-29,ACTUAL,,,,,,,2022-04-04,2022-04-06,ACTUAL,2020-07-10,ACTUAL,2020-07-10,2022-04,2022-04-30,2021-08-30,ACTUAL,2021-08-30,2020-09-20,ACTUAL,2020-09-20,,INTERVENTIONAL,,,"Safety, Tolerability and Immunogenicinity of a Coronavirus-Like Particle COVID-19 Vaccine in Adults Aged 18-55 Years.","A Randomized, Partially-Blinded, Dose-Ranging Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID 19 Vaccine in Adults 18-55 Years of Age",COMPLETED,,PHASE1,180.0,ACTUAL,Medicago,,9.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,INDUSTRY,,,,,,,2021,1.0
NCT03751007,,2018-11-08,2022-10-13,,2023-01-31,2018-11-20,2018-11-23,ACTUAL,2023-01-31,2023-02-01,ACTUAL,,,,2023-01-31,2023-02-01,ACTUAL,2018-10-24,ACTUAL,2018-10-24,2023-01,2023-01-31,2021-10-13,ACTUAL,2021-10-13,2021-10-13,ACTUAL,2021-10-13,,INTERVENTIONAL,,,A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recent-onset Diagnosed Type 1 Diabetes (T1D),"A Prospective, Multi-center, Phase 1b/2a Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Association With Teplizumab in Patients With Clinical Recent-onset Type 1 Diabetes Mellitus (T1D)",COMPLETED,,PHASE1/PHASE2,45.0,ACTUAL,"Precigen Actobio T1D, LLC",,6.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,INDUSTRY,,,,,,,2021,1.0
NCT05017246,,2021-08-16,,,2024-08-29,2021-08-16,2021-08-23,ACTUAL,,,,,,,2024-08-29,2024-09-03,ACTUAL,2022-01-18,ACTUAL,2022-01-18,2024-08,2024-08-31,2024-08-29,ACTUAL,2024-08-29,2024-07-17,ACTUAL,2024-07-17,,INTERVENTIONAL,,,Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy,A Randomized Trial Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy on the Gynecologic Oncology Service.,TERMINATED,,PHASE2,110.0,ACTUAL,Washington University School of Medicine,,2.0,,Low accrual,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,OTHER,,,,,,,2024,0.0
NCT04152863,,2019-11-04,2024-05-28,,2024-07-11,2019-11-04,2019-11-05,ACTUAL,2024-07-11,2024-08-06,ACTUAL,,,,2024-07-11,2024-08-06,ACTUAL,2020-06-05,ACTUAL,2020-06-05,2024-07,2024-07-31,2023-07-12,ACTUAL,2023-07-12,2023-07-12,ACTUAL,2023-07-12,,INTERVENTIONAL,,,"Efficacy, Safety, and Tolerability of Gebasaxturev (V937) Administered Intravenously or Intratumorally With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma (V937-011)","A Phase 2, Randomized Clinical Study of Intravenous or Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma",TERMINATED,,PHASE2,85.0,ACTUAL,Merck Sharp & Dohme LLC,This study was terminated due to the sponsor's development decision.,3.0,,Business Reasons,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,INDUSTRY,,,,,,,2023,0.0
NCT02545049,,2015-09-02,2022-01-25,,2022-04-13,2015-09-07,2015-09-09,ESTIMATED,2022-04-13,2022-04-15,ACTUAL,,,,2022-04-13,2022-04-15,ACTUAL,2015-09-17,ACTUAL,2015-09-17,2022-04,2022-04-30,2021-02-02,ACTUAL,2021-02-02,2021-02-02,ACTUAL,2021-02-02,,INTERVENTIONAL,FIGARO-DKD,Full analysis set (FAS): the FAS comprised all randomized participants (except those with critical GCP violations).,Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease,"A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.",COMPLETED,,PHASE3,7352.0,ACTUAL,Bayer,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,INDUSTRY,,,,,,,2021,1.0
NCT04676087,,2020-11-09,,,2024-08-11,2020-12-17,2020-12-19,ACTUAL,,,,,,,2024-08-11,2024-08-13,ACTUAL,2021-04-21,ACTUAL,2021-04-21,2024-08,2024-08-31,2023-10-11,ACTUAL,2023-10-11,2023-10-11,ACTUAL,2023-10-11,,INTERVENTIONAL,,,Mogamulizumab and Extracorporeal Photopheresis for the Treatment of Sezary Syndrome or Mycosis Fungoides,"Mogamulizumab and Extracorporeal Photopheresis (ECP) for the Treatment of Sézary Syndrome and Erythrodermic Mycosis Fungoides, a Phase 1b/2 Study",TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,Emory University,,1.0,,Lack of funding,f,,,,t,t,f,,,,,,,,,,,2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,OTHER,,,,,,,2023,0.0
NCT03905525,,2019-03-25,,2022-10-04,2023-09-13,2019-04-04,2019-04-05,ACTUAL,,,,2022-10-12,2022-10-17,ACTUAL,2023-09-13,2023-09-15,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2023-09,2023-09-30,2023-06-06,ACTUAL,2023-06-06,2022-09-28,ACTUAL,2022-09-28,,INTERVENTIONAL,TWINSS,,Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome,"A 48-week, 6-arm, Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjogren's Syndrome (TWINSS)",COMPLETED,,PHASE2,273.0,ACTUAL,Novartis,,8.0,,,f,,,,t,t,f,,,,,,,,,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,INDUSTRY,,,,,,,2023,1.0
NCT05081518,,2021-10-05,,,2022-11-07,2021-10-05,2021-10-18,ACTUAL,,,,,,,2022-11-07,2022-11-09,ACTUAL,2021-09-29,ACTUAL,2021-09-29,2022-11,2022-11-30,2022-04-14,ACTUAL,2022-04-14,2022-04-14,ACTUAL,2022-04-14,,INTERVENTIONAL,,,A Study of Lu AG06466 in Participants With Treatment Resistant Focal Epilepsy,"Interventional, Randomized, Double-blind, Crossover, Placebo-controlled, Multiple-dose Lu AG06466 Phase 1 B Study in Patients With Focal Epilepsy Using EEG and PSG to Investigate Its Pharmacodynamic Effects on Prolonged Period of Inter- Icterical Spikes, Sleep and Neuroinflammation",TERMINATED,,PHASE1,1.0,ACTUAL,H. Lundbeck A/S,,2.0,,The study was terminated due to enrolment challenges,f,,,,t,t,f,,,,,,,,,,,2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,INDUSTRY,,,,,,,2022,0.0
NCT05238207,,2022-01-24,,,2023-08-01,2022-02-11,2022-02-14,ACTUAL,,,,,,,2023-08-01,2023-08-02,ACTUAL,2022-03-28,ACTUAL,2022-03-28,2023-08,2023-08-31,2023-05-04,ACTUAL,2023-05-04,2023-05-04,ACTUAL,2023-05-04,,INTERVENTIONAL,,,A Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers,"A Phase Ia/Ib Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BBI-001 in Iron Deficient Volunteers and HH Patients",TERMINATED,,PHASE1,24.0,ACTUAL,Bond Biosciences,,2.0,,Only Part A (single dosing) was conducted due to business considerations,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,INDUSTRY,,,,,,,2023,0.0
NCT04690855,,2020-12-28,2023-04-24,,2023-11-30,2020-12-28,2020-12-31,ACTUAL,2023-11-30,2023-12-04,ACTUAL,,,,2023-11-30,2023-12-04,ACTUAL,2021-10-04,ACTUAL,2021-10-04,2023-11,2023-11-30,2022-12-20,ACTUAL,2022-12-20,2022-02-18,ACTUAL,2022-02-18,,INTERVENTIONAL,TARA,,"A Study to Evaluate TAlazoparib, Radiotherapy and Atezolizumab in gBRCA 1/2 Negative Patients With PD-L1+ Metastatic Triple Negative Breast Cancer","A Multi-institutional Phase II Study to Evaluate Efficacy and Safety of TAlazoparib, Radiotherapy and Atezolizumab in gBRCA 1/2 Negative Patients With PD-L1+ Metastatic Triple Negative Breast Cancer",TERMINATED,,PHASE2,1.0,ACTUAL,Hoosier Cancer Research Network,,1.0,,This study has been terminated due to Lack of Accrual.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,OTHER,,,,,,,2022,0.0
NCT05061251,,2021-09-20,,,2021-12-17,2021-09-20,2021-09-29,ACTUAL,,,,,,,2021-12-17,2022-01-11,ACTUAL,2021-12-01,ESTIMATED,2021-12-01,2021-12,2021-12-31,2023-12-01,ESTIMATED,2023-12-01,2022-12-01,ESTIMATED,2022-12-01,,INTERVENTIONAL,,,Surgical Window of Opportunity Study of Orally Administered BAY 2402234 in Recurrent Glioma,"An Open-Label Surgical Window of Opportunity Study Evaluating Pharmacodynamic Response of Orally Administered BAY 2402234 in Subjects With Recurrent Glioma, IDH Mutant, Grade 3 or 4",WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Texas Southwestern Medical Center,,1.0,,Drug availability,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,OTHER,,,,,,,2023,0.0
NCT03769467,,2018-11-29,,2022-08-17,2022-09-26,2018-12-06,2018-12-07,ACTUAL,,,,,,,2022-09-26,2022-09-30,ACTUAL,2019-02-19,ACTUAL,2019-02-19,2022-09,2022-09-30,2021-08-19,ACTUAL,2021-08-19,2021-08-19,ACTUAL,2021-08-19,,INTERVENTIONAL,,,Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC),"An Open-Label Phase 1B/2 Study to Evaluate the Safety and Efficacy of Tabelecleucel in Combination With Pembrolizumab in Subjects With Platinum-pretreated, Recurrent/Metastatic Epstein-Barr Virus-Associated Nasopharyngeal Carcinoma",TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,Atara Biotherapeutics,,1.0,,"Phase 1B part was completed with review of DLTs and cumulative safety data by Safety Data Review Committee and identification of a safe RP2D. Post-internal review, sponsor decided to terminate the study, and hence, Phase 2 part was not conducted.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,INDUSTRY,,,,,,,2021,0.0
NCT01597778,,2012-05-10,2021-09-10,,2021-11-02,2012-05-10,2012-05-14,ESTIMATED,2021-11-02,2021-12-01,ACTUAL,,,,2021-11-02,2021-12-01,ACTUAL,2012-06,ACTUAL,2012-06-30,2021-11,2021-11-30,2020-09-11,ACTUAL,2020-09-11,2020-09-11,ACTUAL,2020-09-11,,INTERVENTIONAL,,Baseline characteristics for all enrolled participants by treatment arm.,Double Cord Versus Haploidentical (BMT CTN 1101),"A Multi-Center, Phase III, Randomized Trial of RIC and Transplantation of (dUCB) Versus HLA-Haplo Related Bone Marrow for Patients With Hematologic Malignancies.(BMT CTN #1101)",COMPLETED,,PHASE3,368.0,ACTUAL,Medical College of Wisconsin,,2.0,,,f,,,,t,f,f,,,f,,,Within 6 months of official study closure at participating sites.,Available to the public,https://biolincc.nhlbi.nih.gov/home/,YES,"Results will be published in a manuscript and supporting information submitted to NIH BioLINCC (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc where indicated).",2024-10-16 20:09:03.590501,2024-10-16 20:09:03.590501,OTHER,,,,,,,2020,1.0
NCT04003207,,2019-06-27,2024-04-09,,2024-04-09,2019-06-27,2019-07-01,ACTUAL,2024-04-09,2024-05-02,ACTUAL,,,,2024-04-09,2024-05-02,ACTUAL,2019-09-13,ACTUAL,2019-09-13,2024-04,2024-04-30,2020-06-05,ACTUAL,2020-06-05,2020-06-05,ACTUAL,2020-06-05,,INTERVENTIONAL,,,Growth Hormone Treatment in Children With Phelan McDermid Syndrome,An Open Label Trial of Growth Hormone in Children and Adolescents With Phelan-McDermid Syndrome Targeting Social Withdrawal,COMPLETED,,PHASE2,6.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,1.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,OTHER,,,,,,,2020,1.0
NCT05406219,,2022-06-01,,,2023-04-17,2022-06-01,2022-06-06,ACTUAL,,,,,,,2023-04-17,2023-04-19,ACTUAL,2023-05-15,ESTIMATED,2023-05-15,2023-04,2023-04-30,2023-10-12,ESTIMATED,2023-10-12,2023-08-17,ESTIMATED,2023-08-17,,INTERVENTIONAL,,,"A Study to Learn How the Study Treatment BAY2395840 Moves Into, Through and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Moderate Reduced Kidney Function and in Healthy Male and Female Participants With Normal Kidney Function","An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BAY 2395840 in Participants With Moderate Renal Impairment and in Healthy Male and Female Participants With Normal Renal Function",WITHDRAWN,,PHASE1,0.0,ACTUAL,Bayer,,3.0,,Discontinuation of program.,f,,,,f,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,INDUSTRY,,,,,,,2023,0.0
NCT03866317,,2019-02-27,,,2021-08-31,2019-03-06,2019-03-07,ACTUAL,,,,,,,2021-08-31,2021-09-08,ACTUAL,2019-09-01,ACTUAL,2019-09-01,2021-08,2021-08-31,2021-06-30,ACTUAL,2021-06-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,,,A Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus,A Pilot Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus,WITHDRAWN,,PHASE2,0.0,ACTUAL,Massachusetts General Hospital,,1.0,,Difficulty recruiting participants,f,,,,,t,f,,,t,,,,,,UNDECIDED,,2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,OTHER,,,,,,,2021,0.0
NCT02818023,,2016-06-07,,,2021-12-10,2016-06-24,2016-06-29,ESTIMATED,,,,,,,2021-12-10,2022-01-03,ACTUAL,2016-07-13,ACTUAL,2016-07-13,2021-12,2021-12-31,2021-04-23,ACTUAL,2021-04-23,2019-06-10,ACTUAL,2019-06-10,,INTERVENTIONAL,,,Dose-seeking Study of Pembrolizumab Plus Vemurafenib and Cobimetinib Advanced Melanoma,Dose-seeking Study of Pembrolizumab Plus Vemurafenib and Cobimetinib for Therapy of Advanced Melanoma,TERMINATED,,PHASE1,9.0,ACTUAL,University of Pittsburgh,,1.0,,Accrual to trial stopped due to high toxicity even at lowest dose of combination treatment. Patients on trial tolerating treatment at time of accrual closure still continued to receive treatment.,f,,,,t,,,,,,,,,,,NO,,2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,OTHER,,,,,,,2021,0.0
NCT06022224,,2023-08-30,2024-04-02,,2024-06-05,2023-08-30,2023-09-01,ACTUAL,2024-06-05,2024-06-07,ACTUAL,,,,2024-06-05,2024-06-07,ACTUAL,2020-12-09,ACTUAL,2020-12-09,2024-06,2024-06-30,2023-07-19,ACTUAL,2023-07-19,2022-06-23,ACTUAL,2022-06-23,,INTERVENTIONAL,,,A 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELL VACCINE TRIAL,"A Phase 2/3, Placebo-Controlled, Randomized, Observer-Blind Study To Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of a 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELL VACCINE TRIAL",TERMINATED,,PHASE2/PHASE3,35.0,ACTUAL,"ImmunityBio, Inc.","There is an insufficient number of subjects enrolled to evaluate the efficacy of the Investigational Product. Thus, only safety results are provided.",2.0,,There were no participants enrolled into Phase 3 portion of the study because the study was prematurely terminated.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,INDUSTRY,,,,,,,2023,0.0
NCT04421378,,2020-06-01,,,2023-08-31,2020-06-05,2020-06-09,ACTUAL,,,,,,,2023-08-31,2023-09-06,ACTUAL,2020-06-08,ACTUAL,2020-06-08,2023-08,2023-08-31,2023-07-03,ACTUAL,2023-07-03,2023-07-03,ACTUAL,2023-07-03,,INTERVENTIONAL,,,A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma,A Phase 1/2 Study of Selinexor in Combination With Standard of Care (SoC) Therapy for Newly Diagnosed or Recurrent Glioblastoma,TERMINATED,,PHASE1/PHASE2,74.0,ACTUAL,Karyopharm Therapeutics Inc,,8.0,,"Upon further consideration of the existing data and the competitive landscape, Karyopharm Therapeutics Inc has decided not to pursue the ongoing development of Selinexor in GBM at this time.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,INDUSTRY,,,,,,,2023,0.0
NCT03074318,,2017-03-01,2021-11-10,,2022-04-27,2017-03-03,2017-03-08,ACTUAL,2022-04-27,2022-04-29,ACTUAL,,,,2022-04-27,2022-04-29,ACTUAL,2017-09-28,ACTUAL,2017-09-28,2022-04,2022-04-30,2020-11-15,ACTUAL,2020-11-15,2020-11-15,ACTUAL,2020-11-15,,INTERVENTIONAL,,,Avelumab and Trabectedin in Treating Patients With Liposarcoma or Leiomyosarcoma That is Metastatic or Cannot Be Removed by Surgery,A Phase I/II Trial Combining Avelumab and Trabectedin for Advanced Liposarcoma and Leiomyosarcoma,TERMINATED,,PHASE1/PHASE2,35.0,ACTUAL,Fred Hutchinson Cancer Center,,4.0,,Terminated due to PI leaving institution,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,OTHER,,,,,,,2020,0.0
NCT04227275,,2019-12-12,,,2023-08-16,2020-01-09,2020-01-13,ACTUAL,,,,,,,2023-08-16,2023-08-21,ACTUAL,2019-11-22,ACTUAL,2019-11-22,2023-08,2023-08-31,2022-11-07,ACTUAL,2022-11-07,2022-11-07,ACTUAL,2022-11-07,,INTERVENTIONAL,,,A Study of CART-PSMA-TGFβRDN in Patients With Metastatic Castration Resistant Prostate Cancer,"A Phase 1 Open-Label, Multi-Center Study of PSMA Targeted Genetically Modified Chimeric Antigen Receptor T Cells in Patients With Metastatic Castration Resistant Prostate Cancer",TERMINATED,,PHASE1,16.0,ACTUAL,"Tceleron Therapeutics, Inc.",,1.0,,Based on the safety events and evidence of biologic activity without sustained clinical responses the Sponsor finds the risk/benefit analysis unfavorable for patients and has terminated the study.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,INDUSTRY,,,,,,,2022,0.0
NCT01778634,,2013-01-22,2018-03-02,,2020-11-03,2013-01-24,2013-01-29,ESTIMATED,2018-04-18,2018-05-17,ACTUAL,,,,2020-11-03,2020-11-30,ACTUAL,2013-07,,2013-07-31,2020-11,2020-11-30,2020-11-03,ACTUAL,2020-11-03,2016-12,ACTUAL,2016-12-31,,INTERVENTIONAL,AZIPIII,,Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants,"A Phase IIb Randomized, Placebo-controlled, Double-blind Trial of Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants",COMPLETED,,PHASE2,121.0,ACTUAL,"University of Maryland, Baltimore",,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,OTHER,,,,,,,2020,1.0
NCT04259346,,2020-02-05,2022-02-14,,2022-02-14,2020-02-05,2020-02-06,ACTUAL,2022-02-14,2022-04-08,ACTUAL,,,,2022-02-14,2022-04-08,ACTUAL,2020-02-05,ACTUAL,2020-02-05,2022-02-01,2022-02-01,2021-02-19,ACTUAL,2021-02-19,2021-02-19,ACTUAL,2021-02-19,,INTERVENTIONAL,,All randomized participants who received at least one dose of study drug.,A Study of Two Formulations of Ixekizumab in Healthy Participants,Bioequivalence of an Alternate Ixekizumab Formulation Compared to the Commercial Formulation in Healthy Subjects,COMPLETED,,PHASE1,245.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,INDUSTRY,,,,,,,2021,1.0
NCT03802461,,2018-11-08,,,2022-11-01,2019-01-10,2019-01-14,ACTUAL,,,,,,,2022-11-01,2022-11-03,ACTUAL,2019-03-22,ACTUAL,2019-03-22,2022-11,2022-11-30,2024-03-20,ESTIMATED,2024-03-20,2023-12-15,ESTIMATED,2023-12-15,,INTERVENTIONAL,EFFECT-CPE,,Effectiveness of Fecal Flora Alteration for Eradication of Carbapenemase-producing Enterobacteriaceae Colonization,"Effectiveness of Fecal Flora Alteration for Eradication of Carbapenemase-producing Enterobacteriaceae Colonization Trial (EFFECT-CPE): a Multisite, Open-label, Randomized Controlled Feasibility Pilot Trial",SUSPENDED,,PHASE2/PHASE3,40.0,ESTIMATED,"University Health Network, Toronto",,2.0,,Temporarily on hold due to COVID-19 pandemic,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,OTHER,,,,,,,2024,0.0
NCT01164995,,2010-07-09,,,2023-08-31,2010-07-16,2010-07-19,ESTIMATED,,,,,,,2023-08-31,2023-09-07,ACTUAL,2010-07,,2010-07-31,2023-08,2023-08-31,2023-04,ACTUAL,2023-04-30,2023-04,ACTUAL,2023-04-30,,INTERVENTIONAL,M10MKO,,Study With Wee-1 Inhibitor AZD1775 (MK-1775) and Carboplatin to Treat p53 Mutated Refractory and Resistant Ovarian Cancer,Phase II Pharmacological Study With Wee-1 Inhibitor MK-1775 Combined With Carboplatin in Patients With p53 Mutated Epithelial Ovarian Cancer and Early Relapse (< 3 Months) or Progression During Standard First Line Treatment With an Additional Safety and Preliminary Anti-tumor Activity Cohort of Wee-1 Inhibitor AZD1775 Combined With Carboplatin in Patients With Platinum Resistant TP53 Mutated Epithelial Ovarian Cancer,COMPLETED,,PHASE2,24.0,ACTUAL,The Netherlands Cancer Institute,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,OTHER,,,,,,,2023,1.0
NCT04731298,,2020-11-13,2023-09-25,,2023-12-07,2021-01-28,2021-01-29,ACTUAL,2023-12-07,2023-12-28,ACTUAL,,,,2023-12-07,2023-12-28,ACTUAL,2021-05-25,ACTUAL,2021-05-25,2023-12,2023-12-31,2022-04-21,ACTUAL,2022-04-21,2022-04-21,ACTUAL,2022-04-21,,INTERVENTIONAL,,No patients were enrolled in the emapalumab arm.,"Study to Investigate the Pharmacokinetics, Pharmacodynamics and Assess the Efficacy and Safety to Support Dose Selection of Emapalumab in Pre-empting Graft Failure in Patients at High Risk After HSCT.","An Open Label, Single Arm, Multicentre, Proof of Concept, Phase 2 Study to Investigate the Pharmacokinetics, Pharmacodynamics and Assess the Efficacy and Safety to Support Dose Selection of Emapalumab in Pre-empting Graft Failure in Patients at High Risk After Allogeneic Hematopoietic Stem Cell Transplantation",TERMINATED,,PHASE2,2.0,ACTUAL,Swedish Orphan Biovitrum,"The study was prematurely terminated with only 2 patients enrolled. Both patients were in the non-emapalumab treated arm, i.e. no patients received study treatment (emapalumab). Consequently, the majority of analyses were not performed and no conclusion on the efficacy of emapalumab on this patient population could be drawn from the study.",1.0,,"Sponsor Decision related to Business Priorities, Assessment of Development Options",f,,,,t,t,f,,,,,,,,,,,2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,INDUSTRY,,,,,,,2022,0.0
NCT03820908,,2019-01-24,,,2020-08-06,2019-01-27,2019-01-29,ACTUAL,,,,,,,2020-08-06,2020-08-07,ACTUAL,2019-07-18,ACTUAL,2019-07-18,2020-08,2020-08-31,2020-07-22,ACTUAL,2020-07-22,2020-05-19,ACTUAL,2020-05-19,,INTERVENTIONAL,,,Bisantrene for Relapsed /Refractory AML,Bisantrene for Relapsed /Refractory Acute Myelogenous Leukemia (AML),COMPLETED,,PHASE2,10.0,ACTUAL,Sheba Medical Center,,1.0,,,f,,,,f,f,f,,,f,,,,,,,,2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,OTHER_GOV,,,,,,,2020,1.0
NCT03750552,,2018-11-20,2022-07-20,,2022-08-18,2018-11-20,2018-11-23,ACTUAL,2022-08-18,2022-09-14,ACTUAL,,,,2022-08-18,2022-09-14,ACTUAL,2019-01-24,ACTUAL,2019-01-24,2022-08,2022-08-31,2021-07-21,ACTUAL,2021-07-21,2021-07-21,ACTUAL,2021-07-21,,INTERVENTIONAL,SEQUOIA,The Baseline Analysis Population includes all participants from the Randomized Analysis Set.,Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure,"A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure",COMPLETED,,PHASE3,195.0,ACTUAL,Theravance Biopharma,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,"Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.",2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,INDUSTRY,,,,,,,2021,1.0
NCT03593655,,2018-07-10,2022-12-09,,2023-06-20,2018-07-10,2018-07-20,ACTUAL,2023-01-09,2023-02-03,ACTUAL,,,,2023-06-20,2023-06-22,ACTUAL,2019-01-14,ACTUAL,2019-01-14,2023-01,2023-01-31,2021-09-09,ACTUAL,2021-09-09,2021-09-09,ACTUAL,2021-09-09,,INTERVENTIONAL,,,Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population,A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population,COMPLETED,,PHASE2,247.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,NIH,,,,,,,2021,1.0
NCT04860297,,2021-04-21,2024-05-22,,2024-05-22,2021-04-22,2021-04-26,ACTUAL,2024-05-22,2024-06-18,ACTUAL,,,,2024-05-22,2024-06-18,ACTUAL,2021-04-16,ACTUAL,2021-04-16,2024-05,2024-05-31,2023-05-22,ACTUAL,2023-05-22,2023-05-22,ACTUAL,2023-05-22,,INTERVENTIONAL,,Safety set included all participants who received at least 1 dose of study drug in this study.,A Study to Evaluate Safety and Immunogenicity of mRNA-1273 Vaccine to Prevent COVID-19 in Adult Organ Transplant Recipients and in Healthy Adult Participants,"A Phase 3b, Open-Label, Safety and Immunogenicity Study of SARS-CoV-2 mRNA-1273 Vaccine in Adult Solid Organ Transplant Recipients and Healthy Controls",COMPLETED,,PHASE3,234.0,ACTUAL,"ModernaTX, Inc.",Healthy participants cohort was included as a control group in the evaluation of humoral and cell-mediated immune response only; no comparisons of safety data with the healthy participants were made.,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,INDUSTRY,,,,,,,2023,1.0
NCT02756130,,2016-04-22,,,2020-07-22,2016-04-26,2016-04-29,ESTIMATED,,,,,,,2020-07-22,2020-07-24,ACTUAL,2018-08-01,ESTIMATED,2018-08-01,2018-08,2018-08-31,2021-02-01,ESTIMATED,2021-02-01,2020-02-01,ESTIMATED,2020-02-01,,INTERVENTIONAL,,,"Birinapant and Carboplatin in Treating Patients With Recurrent High Grade Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","A Phase I/II, Single Center, Proof-of-Concept Study of Birinapant in Combination With Platinum Based Chemotherapy Targeting Recurrent High Grade Serous Ovarian Carcinomas (HGSOC)",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Jonsson Comprehensive Cancer Center,,1.0,,funding was not secured,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,OTHER,,,,,,,2021,0.0
NCT05375825,,2022-05-14,,,2024-01-31,2022-05-16,2022-05-17,ACTUAL,,,,,,,2024-01-31,2024-02-02,ACTUAL,2024-01-31,ACTUAL,2024-01-31,2024-01,2024-01-31,2024-01-31,ACTUAL,2024-01-31,2024-01-31,ACTUAL,2024-01-31,,INTERVENTIONAL,,,"Phase I Evaluation of Immunotoxin LMB-100 Administered by Normothermic, Intrapleural Perfusion Following Cytoreductive Surgery in Participants With Pleural Mesotheliomas, or Pleural Effusions From Cancers Expressing Mesothelin","Phase I Evaluation of Immunotoxin LMB-100 Administered by Normothermic, Intrapleural Perfusion Following Cytoreductive Surgery in Participants With Pleural Mesotheliomas, or Pleural Effusions From Cancers Expressing Mesothelin",WITHDRAWN,,PHASE1,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,No participants enrolled.,f,,,,,t,f,,,,,,Clinical data available during the study and indefinitely. @@@@@@@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.,Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.,,YES,".All IPD recorded in the medical record will be shared with intramural investigators upon request.@@@@@@@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.",2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,NIH,,,,,,,2024,0.0
NCT03530683,,2018-05-08,,,2024-08-29,2018-05-08,2018-05-21,ACTUAL,,,,,,,2024-08-29,2024-09-03,ACTUAL,2018-05-14,ACTUAL,2018-05-14,2024-08,2024-08-31,2024-07-18,ACTUAL,2024-07-18,2024-07-18,ACTUAL,2024-07-18,,INTERVENTIONAL,,,"A Clinical Trial to Learn About the Study Medicine Called Maplirpacept (PF-07901801), Alone and When Used in Combination With Other Medicines to Treat Participants With Advanced Hematological Malignancies, Including Lymphoma, Leukemia and Multiple Myeloma","A Phase 1a/1b Dose-Escalation and Expansion Trial of TTI-622 in Patients With Advanced Hematologic Malignancies, Including Lymphoma, Leukemia, and Multiple Myeloma",TERMINATED,,PHASE1,189.0,ACTUAL,Pfizer,,7.0,,"A business decision was made by Pfizer to terminate the study. Termination was not due to any safety concerns, requests from regulatory authorities, changes to the benefit/risk profile or any new concerns regarding the investigational product.",f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,INDUSTRY,,,,,,,2024,0.0
NCT03420521,,2017-11-30,2023-10-26,2022-11-02,2023-12-15,2018-01-26,2018-02-05,ACTUAL,2023-12-15,2024-01-09,ACTUAL,,2024-01-09,ACTUAL,2023-12-15,2024-01-09,ACTUAL,2018-03-09,ACTUAL,2018-03-09,2023-12,2023-12-31,2021-11-24,ACTUAL,2021-11-24,2021-11-24,ACTUAL,2021-11-24,,INTERVENTIONAL,,,Nivolumab With Ipilimumab in Subjects With Neuroendocrine Tumors,"An Open-Label, Single Arm Phase II Study of Nivolumab in Combination With Ipilimumab in Subjects With Advanced Neuroendocrine Tumors",TERMINATED,,PHASE2,9.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,Loss of funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,OTHER,,,,,,,2021,0.0
NCT04666623,,2020-12-02,,,2023-10-17,2020-12-07,2020-12-14,ACTUAL,,,,,,,2023-10-17,2023-10-19,ACTUAL,2020-11-25,ACTUAL,2020-11-25,2023-10,2023-10-31,2023-10-11,ACTUAL,2023-10-11,2023-10-11,ACTUAL,2023-10-11,,INTERVENTIONAL,IMPORTANCE,,Compare the Efficacy and Safety of Intranasal Esketamine in Chronic Opioid Refractory Pain,"IMPORTANCE Trial - A Provisional Study-design of a Single-center, Phase II, Double-blinded, Placebo-controlled, Randomized, 4-week Study to Compare the Efficacy and Safety of Intranasal Esketamine in Chronic Opioid Refractory Pain",WITHDRAWN,,PHASE2,0.0,ACTUAL,"University Hospital, Basel, Switzerland",,2.0,,investigator decision,f,,,,t,f,f,,,,,,,,,,,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,OTHER,,,,,,,2023,0.0
NCT03126435,,2017-04-19,2022-11-07,,2023-05-05,2017-04-19,2017-04-24,ACTUAL,2023-03-01,2023-03-24,ACTUAL,,,,2023-05-05,2023-05-06,ACTUAL,2018-10-16,ACTUAL,2018-10-16,2023-05,2023-05-31,2021-10-08,ACTUAL,2021-10-08,2021-07-30,ACTUAL,2021-07-30,,INTERVENTIONAL,,,EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX,"A Randomized Controlled, Open Label, Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1+GEM vs GEM Alone in Patients With Measurable Locally Advanced/Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment",COMPLETED,,PHASE3,218.0,ACTUAL,"SynCore Biotechnology Co., Ltd.",,2.0,,,,,,,,t,f,,,,,,,,,,,2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,INDUSTRY,,,,,,,2021,1.0
NCT03685344,,2018-09-11,2021-08-10,,2021-09-28,2018-09-24,2018-09-26,ACTUAL,2021-09-28,2021-10-26,ACTUAL,,,,2021-09-28,2021-10-26,ACTUAL,2019-02-04,ACTUAL,2019-02-04,2021-09,2021-09-30,2020-10-27,ACTUAL,2020-10-27,2020-10-27,ACTUAL,2020-10-27,,INTERVENTIONAL,,"Safety analysis set - All participants who received the study drug. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated, therefore data is only available for the dose escalation.","Safety and Antitumor Activity Study of Loncastuximab Tesirine and Durvalumab in Diffuse Large B-Cell, Mantle Cell, or Follicular Lymphoma","A Phase 1 Open-Label Study to Evaluate the Safety and Antitumor Activity of Loncastuximab Tesirine and Durvalumab in Patients With Advanced Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma",TERMINATED,,PHASE1,13.0,ACTUAL,ADC Therapeutics S.A.,,1.0,,"In a limited number of patients, no additional activity was evident for the combination vs. loncastuximab tesirine monotherapy.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,INDUSTRY,,,,,,,2020,0.0
NCT03819660,,2019-01-23,2023-09-01,,2023-11-29,2019-01-24,2019-01-28,ACTUAL,2023-11-29,2023-11-30,ACTUAL,,,,2023-11-29,2023-11-30,ACTUAL,2019-03-07,ACTUAL,2019-03-07,2023-11,2023-11-30,2021-09-13,ACTUAL,2021-09-13,2021-09-13,ACTUAL,2021-09-13,,INTERVENTIONAL,SMA3,,Long Term Safety of Amifampridine Phosphate in Spinal Muscular Atrophy 3,Long Term Safety Study of Amifampridine Phosphate in Ambulatory Patients With Spinal Muscular Atrophy (SMA) Type 3,TERMINATED,,PHASE2,13.0,ACTUAL,"Catalyst Pharmaceuticals, Inc.",The results of efficacy are limited to the assessment of quality of life using the INQoL. The premature interruption of the study determined that few patients had available data of INQoL from Month 6 onwards.,1.0,,Development of indication not being pursued,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,INDUSTRY,,,,,,,2021,0.0
NCT03385928,,2017-12-13,,,2023-09-25,2017-12-20,2017-12-29,ACTUAL,,,,,,,2023-09-25,2023-09-28,ACTUAL,2018-03-19,ACTUAL,2018-03-19,2023-09,2023-09-30,2023-05-28,ACTUAL,2023-05-28,2023-05-28,ACTUAL,2023-05-28,,INTERVENTIONAL,,,STOP-MSU: Stopping Haemorrhage With Tranexamic Acid for Hyperacute Onset Presentation Including Mobile Stroke Units,"STOP-MSU: Stopping Haemorrhage With Tranexamic Acid for Hyperacute Onset Presentation Including Mobile Stroke Units. A Phase II Randomised, Placebo-controlled, Investigator-driven Trial of Tranexamic Acid Within 2 Hours of Intracerebral Haemorrhage",COMPLETED,,PHASE2,201.0,ACTUAL,Neuroscience Trials Australia,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,OTHER,,,,,,,2023,0.0
NCT03046927,,2017-02-01,2022-04-08,,2024-06-18,2017-02-05,2017-02-08,ESTIMATED,2024-06-18,2024-07-10,ACTUAL,,,,2024-06-18,2024-07-10,ACTUAL,2017-10-19,ACTUAL,2017-10-19,2024-06,2024-06-30,2021-04-20,ACTUAL,2021-04-20,2021-04-12,ACTUAL,2021-04-12,,INTERVENTIONAL,PCR,,Vitamin D and Residual Beta-Cell Function in Type 1 Diabetes,Vitamin D and Residual Beta-Cell Function in Type 1 Diabetes,COMPLETED,,PHASE2/PHASE3,48.0,ACTUAL,"University of Massachusetts, Worcester",,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,No.,2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,OTHER,,,,,,,2021,1.0
NCT03410056,,2018-01-03,2021-05-11,2020-10-29,2021-06-10,2018-01-18,2018-01-25,ACTUAL,2021-05-11,2021-06-04,ACTUAL,2020-10-29,2020-11-02,ACTUAL,2021-06-10,2021-06-22,ACTUAL,2018-05-22,ACTUAL,2018-05-22,2021-06,2021-06-30,2020-05-13,ACTUAL,2020-05-13,2019-12-10,ACTUAL,2019-12-10,,INTERVENTIONAL,,The safety analysis set: All participants who received at least 1 dose of investigational product.~Only cohorts with enrolled participants are included in the baseline population.,Safety and Efficacy of Efavaleukin Alfa in Subjects With Active Rheumatoid Arthritis,A Phase 1b/2a Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa in Subjects With Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy,TERMINATED,,PHASE1/PHASE2,36.0,ACTUAL,Amgen,Enrollment of the phase 1b part of this study was stopped as of 30 September 2019 due to data that suggested that there is not sufficient benefit-risk for the use of Efavaleukin alfa plus standard of care therapy in this study population. The study was terminated prior to the enrollment of any participants into phase 1b Cohort 4 and phase 2a cohorts.,7.0,,Amgen made a business decision not to proceed with Phase 2.,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,INDUSTRY,,,,,,,2020,0.0
NCT03852992,,2019-02-21,,,2023-09-11,2019-02-21,2019-02-25,ACTUAL,,,,,,,2023-09-11,2023-09-13,ACTUAL,2022-09-30,ESTIMATED,2022-09-30,2023-09,2023-09-30,2023-07-01,ESTIMATED,2023-07-01,2023-07-01,ESTIMATED,2023-07-01,,INTERVENTIONAL,,,Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia,"The Safety and Efficacy of Fractional Ablative 10, 600nm CO2 Laser-assisted Treatments for Male Pattern Hair Loss: a Randomized Cohort Study Comparing Stand-alone Laser Treatment, Laser Assisted Drug Delivery of Minoxidil 2% Solution , and Laser Assisted Drug Delivery of Minoxidil 2% Solution Plus Self-administration of Minoxidil 5% at Home.",WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Minnesota,,4.0,,Study was closed with IRB on 10/22/22,f,,,,f,t,t,,,,,,,,,NO,,2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,OTHER,,,,,,,2023,0.0
NCT05009953,,2021-08-04,,,2024-07-09,2021-08-10,2021-08-18,ACTUAL,,,,,,,2024-07-09,2024-07-11,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2024-06,2024-06-30,2023-01-16,ACTUAL,2023-01-16,2023-01-16,ACTUAL,2023-01-16,,INTERVENTIONAL,,,Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer,"An Open-label, Multicentre, Phase II Study to Evaluate the Safety and Efficacy of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer",TERMINATED,,PHASE2,17.0,ACTUAL,"CSPC Ouyi Pharmaceutical Co., Ltd.",,2.0,,Internal strategy change. Not related to safety concerns.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,INDUSTRY,,,,,,,2023,0.0
NCT03145558,,2017-05-03,,,2022-11-01,2017-05-04,2017-05-09,ACTUAL,,,,,,,2022-11-01,2022-11-04,ACTUAL,2017-12-05,ACTUAL,2017-12-05,2022-11,2022-11-30,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,TATE,,TATE Versus TACE in Intermediate Stage HCC,"TATE Versus TACE, an Open-label Randomized Study Comparing TransArterial Tirapazamine Embolization Versus TransArterial ChemoEmbolization in Intermediate Stage Hepatocellular Carcinoma",SUSPENDED,,PHASE2,134.0,ESTIMATED,Teclison Ltd.,,2.0,,on hold by sponsor,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,INDUSTRY,,,,,,,2024,0.0
NCT02712905,,2016-02-18,2023-04-10,,2023-05-15,2016-03-15,2016-03-18,ESTIMATED,2023-05-15,2023-06-12,ACTUAL,,,,2023-05-15,2023-06-12,ACTUAL,2016-05-05,ACTUAL,2016-05-05,2023-05,2023-05-31,2022-04-14,ACTUAL,2022-04-14,2022-04-14,ACTUAL,2022-04-14,,INTERVENTIONAL,,,"An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies","A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies",TERMINATED,,PHASE1/PHASE2,116.0,ACTUAL,Incyte Corporation,The study was terminated by the sponsor due to a strategic business decision.,2.0,,Strategic Business Decision,f,,,,t,t,,,,,,,,,,,,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,INDUSTRY,,,,,,,2022,0.0
NCT02699138,,2016-02-24,,,2019-07-08,2016-03-03,2016-03-04,ESTIMATED,,,,,,,2019-07-08,2019-07-10,ACTUAL,2021-10,ESTIMATED,2021-10-31,2019-07,2019-07-31,2022-12,ESTIMATED,2022-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Obstructive Sleep Apnea and Arousal Threshold in Patients With Post-traumatic Stress Disorder,Obstructive Sleep Apnea and Arousal Threshold in Patients With Post-traumatic,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,"University of California, San Diego",,2.0,,Research fellow left institution,f,,,,,f,t,,,,,,,,,,,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,OTHER,,,,,,,2022,0.0
NCT03230916,,2017-07-17,2021-07-21,,2024-01-12,2017-07-26,2017-07-27,ACTUAL,2021-10-28,2021-12-13,ACTUAL,,,,2024-01-12,2024-02-06,ACTUAL,2017-11-06,ACTUAL,2017-11-06,2024-01,2024-01-31,2020-08-11,ACTUAL,2020-08-11,2020-07-28,ACTUAL,2020-07-28,,INTERVENTIONAL,,,A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020),"A Phase 1b, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of MK-7655A in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Infections",COMPLETED,,PHASE1,47.0,ACTUAL,Merck Sharp & Dohme LLC,,1.0,,,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 13:31:22.247657,2024-10-15 13:31:22.247657,INDUSTRY,,,,,,,2020,1.0
NCT03272633,,2017-08-24,2023-03-20,,2023-06-23,2017-09-01,2017-09-05,ACTUAL,2023-06-23,2023-06-26,ACTUAL,,,,2023-06-23,2023-06-26,ACTUAL,2020-10-26,ACTUAL,2020-10-26,2023-06,2023-06-30,2022-09-22,ACTUAL,2022-09-22,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,No participants qualified for cohort I,Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies,Post-Transplant Use of Irradiated Haplo-Allogeneic Cells,TERMINATED,,EARLY_PHASE1,2.0,ACTUAL,"Rutgers, The State University of New Jersey",,2.0,,Lack of enrollment,,,,,t,t,f,,,,,,,,,,,2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,OTHER,,,,,,,2022,0.0
NCT04330638,,2020-03-31,2022-09-13,,2023-02-13,2020-03-31,2020-04-01,ACTUAL,2023-02-13,2023-03-14,ACTUAL,,,,2023-02-13,2023-03-14,ACTUAL,2020-04-03,ACTUAL,2020-04-03,2023-02,2023-02-28,2021-05-21,ACTUAL,2021-05-21,2020-12-20,ACTUAL,2020-12-20,,INTERVENTIONAL,COV-AID,The study investigates IL-6 and IL-1 blockade 339 participants received IL Blockade: 227 participants IL-6 blockade + 112 participants IL-1 blockade; 345 participants No Blockade: 230 participants no IL-6 blockade + 115 participants no IL-1 blockade,Treatment of COVID-19 Patients With Anti-interleukin Drugs,"A Prospective, Randomized, Factorial Design, Interventional Study to Compare the Safety and Efficacy of Combinations of Blockade of Interleukin-6 Pathway and Interleukin-1 Pathway to Best Standard of Care in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 Patients With Acute Hypoxic Respiratory Failure and Systemic Cytokine Release Syndrome",COMPLETED,,PHASE3,342.0,ACTUAL,"University Hospital, Ghent",,6.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,OTHER,,,,,,,2021,0.0
NCT03284723,,2017-09-01,2022-07-21,,2024-08-27,2017-09-13,2017-09-15,ACTUAL,2024-08-27,2024-09-03,ACTUAL,,,,2024-08-27,2024-09-03,ACTUAL,2017-11-01,ACTUAL,2017-11-01,2024-08,2024-08-31,2021-08-31,ACTUAL,2021-08-31,2021-08-31,ACTUAL,2021-08-31,,INTERVENTIONAL,,Baseline analysis population included all enrolled participants who received at least one dose of study treatment.,PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors,A Phase 1 Dose Escalation Study Evaluating the Safety and Tolerability of PF-06804103 in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive and Negative Solid Tumors,TERMINATED,,PHASE1,95.0,ACTUAL,Pfizer,"On 10 February 2021, a decision was made by the sponsor to terminate the study due to business reasons. The decision was not due to any urgent patient safety concerns, study conduct issues, or regulatory authority requests concerning treatment with the PF-06804103 compound. Part 2B had not enrolled prior to the termination of the study.",2.0,,The trial was terminated based on the stage in drug development and assessment of PF-06804103 relative to the leading external competition. The decision was not due to a safety concern.,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,INDUSTRY,,,,,,,2021,0.0
NCT04023240,,2019-07-15,,,2024-08-09,2019-07-15,2019-07-17,ACTUAL,,,,,,,2024-08-09,2024-08-12,ACTUAL,2023-07,ESTIMATED,2023-07-31,2024-08,2024-08-31,2023-12-14,ESTIMATED,2023-12-14,2023-07-14,ESTIMATED,2023-07-14,,INTERVENTIONAL,,,68-Ga-FAPI PET Imaging in Malignancy,68Ga-FAPI PET Imaging in Malignancy,WITHDRAWN,,PHASE2,0.0,ACTUAL,Stanford University,,1.0,,no patients enrolled into study,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,OTHER,,,,,,,2023,0.0
NCT04402385,,2020-05-22,2023-06-21,,2023-06-21,2020-05-22,2020-05-26,ACTUAL,2023-06-21,2023-07-11,ACTUAL,,,,2023-06-21,2023-07-11,ACTUAL,2020-08-06,ACTUAL,2020-08-06,2023-06,2023-06-30,2022-06-22,ACTUAL,2022-06-22,2022-06-22,ACTUAL,2022-06-22,,INTERVENTIONAL,,Participants from the initially enrolled that delivered successfully.,Aspirin to Prevent Preeclampsia in Women With Elevated Blood Pressure and Stage 1 Hypertension (ASPPIRE),Aspirin to Prevent Preeclampsia in Women With Elevated Blood Pressure and Stage 1 Hypertension (ASPPIRE),TERMINATED,,PHASE2,50.0,ACTUAL,Yale University,,2.0,,Unable to recruit.,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,OTHER,,,,,,,2022,0.0
NCT03334656,,2017-10-30,,,2024-08-08,2017-11-02,2017-11-07,ACTUAL,,,,,,,2024-08-08,2024-08-12,ACTUAL,2018-05-16,ACTUAL,2018-05-16,2024-08,2024-08-31,2024-07-15,ACTUAL,2024-07-15,2024-07-15,ACTUAL,2024-07-15,,INTERVENTIONAL,CICAFAST,,Controlled Comparison of a Traditional Dressing Versus a Biologic Dressing Composed of Fetal Fibroblasts and Keratinocytes in Association With a Collagen Matrix on Skin Donor Sites,Controlled Comparison of a Traditional Dressing Versus a Biologic Dressing Composed of Fetal Fibroblasts and Keratinocytes in Association With a Collagen Matrix on Skin Donor Sites,TERMINATED,,PHASE1/PHASE2,28.0,ACTUAL,Nantes University Hospital,,2.0,,"It was decided to terminate the study prematurely due to insufficient enrolment, despite extensions to the enrolment period.",f,,,,,f,f,,,,,,,,,,,2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,OTHER,,,,,,,2024,0.0
NCT04159701,,2019-11-08,2022-02-14,,2022-02-14,2019-11-08,2019-11-12,ACTUAL,2022-02-14,2022-03-11,ACTUAL,,,,2022-02-14,2022-03-11,ACTUAL,2019-11-15,ACTUAL,2019-11-15,2022-02,2022-02-28,2021-02-24,ACTUAL,2021-02-24,2021-02-24,ACTUAL,2021-02-24,,INTERVENTIONAL,,All randomized participants.,A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Crossover Study to Evaluate the Efficacy and Safety of LY3454738 in Adults With Chronic Spontaneous Urticaria Inadequately Controlled With H1-Antihistamines",TERMINATED,,PHASE2,52.0,ACTUAL,Eli Lilly and Company,The study was terminated for lack of efficacy after an interim analysis was performed.,2.0,,The study was terminated for lack of efficacy after an interim analysis was performed,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,INDUSTRY,,,,,,,2021,0.0
NCT04524195,,2020-08-19,,,2024-01-12,2020-08-19,2020-08-24,ACTUAL,,,,,,,2024-01-12,2024-01-17,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2024-01,2024-01-31,2023-11-27,ACTUAL,2023-11-27,2023-11-27,ACTUAL,2023-11-27,,INTERVENTIONAL,,,PET Imaging With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC),A Study of PET Imaging of T-cell Activation With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1-directed Therapy,TERMINATED,,PHASE1,4.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,The study is terminated because the PI left the institution.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,OTHER,,,,,,,2023,0.0
NCT05156671,,2021-12-02,,,2023-12-27,2021-12-09,2021-12-14,ACTUAL,,,,,,,2023-12-27,2024-01-03,ACTUAL,2022-10-06,ACTUAL,2022-10-06,2023-12,2023-12-31,2023-11-15,ACTUAL,2023-11-15,2023-08-25,ACTUAL,2023-08-25,,INTERVENTIONAL,AGNES-19,,Adrecizumab (HAM8101) to Improve Prognosis and Outcomes in COVID-19 Trial,"Multicenter, Randomized, Double-blind, Biomarker-guided, Phase II Trial With Adrecizumab (HAM 8101) to Improve proGNosis and outcomES in Patients With Moderate to Severe COVID-19",TERMINATED,,PHASE2,16.0,ACTUAL,Universitätsklinikum Hamburg-Eppendorf,,2.0,,Due to poor recruitment.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,OTHER,,,,,,,2023,0.0
NCT06411067,,2020-03-06,,,2024-05-07,2024-05-07,2024-05-13,ACTUAL,,,,,,,2024-05-07,2024-05-13,ACTUAL,2020-02-26,ACTUAL,2020-02-26,2024-05,2024-05-31,2022-05-09,ACTUAL,2022-05-09,2022-05-09,ACTUAL,2022-05-09,,INTERVENTIONAL,,,Investigational Use of Erenumab for the Treatment of Fibromyalgia Pain,Investigational Use of Erenumab for the Treatment of Fibromyalgia Pain,TERMINATED,,PHASE3,5.0,ACTUAL,"United States Naval Medical Center, Portsmouth",,2.0,,Lapse in IRB approval,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,FED,,,,,,,2022,0.0
NCT02565511,,2015-09-28,2021-04-29,,2021-07-07,2015-09-29,2015-10-01,ESTIMATED,2021-07-07,2021-07-08,ACTUAL,,,,2021-07-07,2021-07-08,ACTUAL,2015-11-30,ACTUAL,2015-11-30,2021-07,2021-07-31,2020-04-30,ACTUAL,2020-04-30,2020-04-30,ACTUAL,2020-04-30,,INTERVENTIONAL,GS1,Three participants were included in the Participant Flow in Cohort II but not included in Baseline Characteristics because they were mis-randomized.,A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease,"A Randomized, Double-blind, Placebo-controlled, Two-cohort, Parallel Group Study to Evaluate the Efficacy of CAD106 and CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease.",TERMINATED,,PHASE2/PHASE3,480.0,ACTUAL,Novartis,"The study was terminated due to unexpected changes in cognitive function, brain volume loss, and body weight loss. Cohort II (CNP520) treatment was stopped and evaluated through an off-treatment follow-up period. After the decision to terminate Cohort II of the study (CNP520), treatment with CAD106 (Cohort I) was also terminated",4.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,INDUSTRY,,,,,,,2020,0.0
NCT02851797,,2016-07-27,2022-12-02,,2023-01-09,2016-07-28,2016-08-02,ESTIMATED,2023-01-09,2023-02-02,ACTUAL,,,,2023-01-09,2023-02-02,ACTUAL,2017-06-06,ACTUAL,2017-06-06,2023-01,2023-01-31,2022-02-22,ACTUAL,2022-02-22,2022-02-22,ACTUAL,2022-02-22,,INTERVENTIONAL,,Number of Subjects Enrolled in Each Country (Overall Population).The all-enrolled subjects set included all subjects who were randomised to study treatment. The overall all-enrolled subjects set included all subjects in both the target and off-target populations (Group A + Group B) who were randomised to study treatment.,Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy,"Randomised, Double Blind, Placebo Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy",COMPLETED,,PHASE3,179.0,ACTUAL,Italfarmaco,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,INDUSTRY,,,,,,,2022,1.0
NCT02371577,,2015-02-13,,,2017-04-26,2015-02-19,2015-02-25,ESTIMATED,,,,,,,2017-04-26,2017-04-28,ACTUAL,2017-02-01,ESTIMATED,2017-02-01,2017-04,2017-04-30,2020-12,ESTIMATED,2020-12-31,2018-12,ESTIMATED,2018-12-31,,INTERVENTIONAL,Revlimid,,Evaluation of the Immune Restoration Potential Of Lenalidomide,A Phase 2 Clinical Trial To Evaluate The Immune Restoration Potential Of Lenalidomide For Patients With CLL-Associated Immunodeficiency,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, San Diego",,1.0,,withdrawn,f,,,,t,t,f,,,,,,,,,,,2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,OTHER,,,,,,,2020,0.0
NCT04403568,,2020-05-21,,,2021-09-08,2020-05-21,2020-05-27,ACTUAL,,,,,,,2021-09-08,2021-09-16,ACTUAL,2021-10,ESTIMATED,2021-10-31,2021-09,2021-09-30,2023-12,ESTIMATED,2023-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,"Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate","Phase I Clinical Trial Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate",WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,The University of Texas Health Science Center at San Antonio,,3.0,,"No subjects were enrolled in this study, the PI will seek funding and revise the protocol for resubmisson at a later date",f,,,,t,t,f,,,t,,,De-identified individual participant data will be available upon completion of the study for approx. 1 year.,Access granted upon request.,,YES,De-identified individual participant data will be available upon request.,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,OTHER,,,,,,,2023,0.0
NCT04588129,,2020-10-06,,,2022-04-28,2020-10-08,2020-10-19,ACTUAL,,,,,,,2022-04-28,2022-05-04,ACTUAL,2021-01-05,ACTUAL,2021-01-05,2022-04,2022-04-30,2021-11-15,ACTUAL,2021-11-15,2021-09-17,ACTUAL,2021-09-17,,INTERVENTIONAL,,,Receptor Occupancy of LB-102 Using Positron Emission Tomography (PET) in Healthy Volunteers,An Open Label Positron Emission Tomography (PET) Study to Evaluate Dopamine Receptor Occupancy of LB-102 Administered Orally to Healthy Subjects,COMPLETED,,PHASE1,16.0,ACTUAL,LB Pharmaceuticals Inc.,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,INDUSTRY,,,,,,,2021,1.0
NCT04575610,,2020-08-05,,,2021-10-18,2020-10-02,2020-10-05,ACTUAL,,,,,,,2021-10-18,2021-10-26,ACTUAL,2020-11-27,ACTUAL,2020-11-27,2021-10,2021-10-31,2021-10-06,ACTUAL,2021-10-06,2021-10-06,ACTUAL,2021-10-06,,INTERVENTIONAL,,,IRAK4 Inhibition in Treatment of COVID-19 With ARDS (I-RAMIC),Investigation of IRAK4 Inhibition to Mitigate the Impact of COVID-19 in Severe SARS-CoV-2 (I-RAMIC),TERMINATED,,PHASE2,7.0,ACTUAL,Yale University,,2.0,,Study terminated due to lack of enrollment reflecting the decrease in number of COVID infections. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,OTHER,,,,,,,2021,0.0
NCT02664181,,2016-01-22,2020-11-09,,2024-08-14,2016-01-25,2016-01-26,ESTIMATED,2020-12-09,2020-12-10,ACTUAL,,,,2024-08-14,2024-09-03,ACTUAL,2017-06-06,ACTUAL,2017-06-06,2024-08,2024-08-31,2024-05-19,ACTUAL,2024-05-19,2019-07-02,ACTUAL,2019-07-02,,INTERVENTIONAL,PRECISE,Participants enrolled in study,Rational EpigenetiC Immunotherapy for SEcond Line Therapy in Patients With NSCLC: PRECISE Trial,"Phase II Evaluation of Nivolumab, an Immune Checkpoint Inhibitor Alone or in Combination With Oral Decitabine/Tetrahydrouridine as Second Line Therapy for Non-small Cell Lung Cancer",COMPLETED,,PHASE2,13.0,ACTUAL,Case Comprehensive Cancer Center,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,OTHER,,,,,,,2024,1.0
NCT01597973,,2012-05-08,2021-08-09,,2022-11-10,2012-05-10,2012-05-15,ESTIMATED,2021-11-03,2021-11-30,ACTUAL,,,,2022-11-10,2022-11-14,ACTUAL,2012-10-06,ACTUAL,2012-10-06,2022-11,2022-11-30,2020-08-09,ACTUAL,2020-08-09,2020-08-09,ACTUAL,2020-08-09,,INTERVENTIONAL,,,Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME),Randomized Controlled Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME),COMPLETED,,PHASE3,467.0,ACTUAL,University of Michigan,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,OTHER,,,,,,,2020,1.0
NCT04404712,,2020-05-22,,,2023-02-16,2020-05-26,2020-05-27,ACTUAL,,,,,,,2023-02-16,2023-02-21,ACTUAL,2020-09-23,ACTUAL,2020-09-23,2023-02,2023-02-28,2021-06-30,ACTUAL,2021-06-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,,,FAAH Availability in Psychiatric Disorders: A PET Study,FAAH Availability in Psychiatric Disorders: A PET Study,TERMINATED,,EARLY_PHASE1,6.0,ACTUAL,Yale University,,1.0,,Ligand was not effective.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,OTHER,,,,,,,2021,0.0
NCT04091581,,2019-09-13,2021-03-25,,2022-06-01,2019-09-16,2019-09-17,ACTUAL,2022-06-01,2022-06-22,ACTUAL,,,,2022-06-01,2022-06-22,ACTUAL,2019-11-21,ACTUAL,2019-11-21,2022-06,2022-06-30,2020-02-06,ACTUAL,2020-02-06,2020-02-06,ACTUAL,2020-02-06,,INTERVENTIONAL,BULLDOG,,Comparison of Tear Evaporation Rate With Systane Complete in Dry Eye and Non-Dry Eye,Comparison of Tear Evaporation Rate With Systane Complete in Dry Eye and Non-Dry Eye,COMPLETED,,PHASE4,21.0,ACTUAL,University of Waterloo,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,OTHER,,,,,,,2020,1.0
NCT05646459,,2020-04-21,,,2024-08-29,2022-12-01,2022-12-12,ACTUAL,,,,,,,2024-08-29,2024-09-03,ACTUAL,2020-05-14,ACTUAL,2020-05-14,2024-08,2024-08-31,2020-05-14,ACTUAL,2020-05-14,2020-05-14,ACTUAL,2020-05-14,,INTERVENTIONAL,,,Effect of Local Cannabidiol on Clinical and Inflammatory Outcomes in Periodontal Maintenance Patients.,Effect of Local Cannabidiol on Clinical and Inflammatory Outcomes in Periodontal Maintenance Patients.,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Nebraska,,3.0,,Study was unable to obtain IRB approval because CBD was not legal in Nebraska at that time.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,OTHER,,,,,,,2020,0.0
NCT03864419,,2019-03-01,,,2023-12-27,2019-03-04,2019-03-06,ACTUAL,,,,,,,2023-12-27,2024-01-03,ACTUAL,2019-10-24,ACTUAL,2019-10-24,2023-12,2023-12-31,2023-07-26,ACTUAL,2023-07-26,2023-07-26,ACTUAL,2023-07-26,,INTERVENTIONAL,,,Rituximab Hyaluronidase in Combination With Chemotherapy in Treating Aggressive B-cell Lymphoma in Uganda,"A Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With Local Standard-of-Care Chemotherapy for the Treatment of Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma or as Monotherapy for Kaposi Sarcoma Herpesvirus Associated Multicentric Castleman Disease in Pediatrics and Adults in Uganda",TERMINATED,,PHASE1,18.0,ACTUAL,Fred Hutchinson Cancer Center,,4.0,,Closed per SRC Low Accrual Policy,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,OTHER,,,,,,,2023,0.0
NCT04026165,,2019-07-17,2022-08-31,,2022-11-29,2019-07-18,2019-07-19,ACTUAL,2022-11-29,2022-12-21,ACTUAL,,,,2022-11-29,2022-12-21,ACTUAL,2019-07-24,ACTUAL,2019-07-24,2022-11,2022-11-30,2021-09-03,ACTUAL,2021-09-03,2021-09-03,ACTUAL,2021-09-03,,INTERVENTIONAL,MOSAIC,The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.,Study to Evaluate the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease,"MOSAIC - A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Selonsertib in Subjects With Moderate to Advanced Diabetic Kidney Disease",COMPLETED,,PHASE2,384.0,ACTUAL,Gilead Sciences,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,INDUSTRY,,,,,,,2021,1.0
NCT04393597,,2020-05-13,,,2020-06-10,2020-05-17,2020-05-19,ACTUAL,,,,,,,2020-06-10,2020-06-12,ACTUAL,2020-05-28,ESTIMATED,2020-05-28,2020-06,2020-06-30,2020-11-30,ESTIMATED,2020-11-30,2020-07-31,ESTIMATED,2020-07-31,,INTERVENTIONAL,,,Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults,"A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics of Orally Administered DWJ1458 in Healthy Adults",WITHDRAWN,,PHASE1,0.0,ACTUAL,Daewoong Pharmaceutical Co. LTD.,,2.0,,We decided to discontinue this particular clinical study through internal discussion.,f,,,,,f,f,,,,,,,,,NO,,2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,INDUSTRY,,,,,,,2020,0.0
NCT03073876,,2017-02-15,2019-06-12,,2021-01-13,2017-03-02,2017-03-08,ACTUAL,2019-10-18,2019-11-05,ACTUAL,,,,2021-01-13,2021-02-04,ACTUAL,2005-12-01,ACTUAL,2005-12-01,2021-01,2021-01-31,2021-01-13,ACTUAL,2021-01-13,2009-07-31,ACTUAL,2009-07-31,,INTERVENTIONAL,,,Detecting an Early Response to Donepezil With Measures of Visual Attention,Detecting an Early Response to Donepezil With Measures of Visual Attention,COMPLETED,,PHASE4,25.0,ACTUAL,NYU Langone Health,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,OTHER,,,,,,,2021,1.0
NCT04570436,,2020-09-24,2023-11-06,,2024-07-22,2020-09-24,2020-09-30,ACTUAL,2023-12-04,2023-12-06,ACTUAL,,,,2024-07-22,2024-07-24,ACTUAL,2021-03-29,ACTUAL,2021-03-29,2024-07,2024-07-31,2022-11-10,ACTUAL,2022-11-10,2022-11-10,ACTUAL,2022-11-10,,INTERVENTIONAL,,"All participants who completed all 5 treatment periods of the Treatment Phase, excluding those subjects who had scores for the primary endpoint (maximum Drug Liking Visual Analog Scale score) that were within 5 points across all 5 treatments and/or had high placebo scores for the primary endpoint (maximum Drug Liking Visual Analog Scale score for placebo was \> 60 on a 100 point scale and the primary endpoint for placebo was 5 or more points greater than that for the positive control, diazepam)",Evaluating the Abuse Potential of NEURONTIN® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experience,"A Phase 4, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Single-dose, Five-way Crossover Study Evaluating the Abuse Potential of Three Doses of NEURONTIN® Taken Orally in Healthy, Non-drug Dependent Participants With Sedative Drug Abuse Experience",COMPLETED,,PHASE4,52.0,ACTUAL,Viatris Inc.,,5.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,INDUSTRY,,,,,,,2022,1.0
NCT01988779,,2013-11-13,2019-11-21,,2021-03-02,2013-11-13,2013-11-20,ESTIMATED,2019-11-21,2019-12-11,ACTUAL,,,,2021-03-02,2021-03-24,ACTUAL,2013-10,ACTUAL,2013-10-31,2021-03,2021-03-31,2020-12-31,ACTUAL,2020-12-31,2017-09-11,ACTUAL,2017-09-11,,INTERVENTIONAL,,,Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations,Oral Versus Topical Antibiotic Therapy for Treatment of Chronic Rhinosinusitis Exacerbations,COMPLETED,,PHASE3,33.0,ACTUAL,University of Rochester,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,OTHER,,,,,,,2020,1.0
NCT04151719,,2019-11-01,,,2021-05-05,2019-11-01,2019-11-05,ACTUAL,,,,,,,2021-05-05,2021-05-07,ACTUAL,2020-02-03,ESTIMATED,2020-02-03,2021-05,2021-05-31,2024-02-03,ESTIMATED,2024-02-03,2024-02-03,ESTIMATED,2024-02-03,,INTERVENTIONAL,,,An Extension Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer,An Open-Label Extension Study to Evaluate the Safety and Efficacy of Oral Methylnaltrexone Bromide Tablets in Subjects With Advanced Pancreatic Cancer,WITHDRAWN,,PHASE3,0.0,ACTUAL,"Bausch Health Americas, Inc.",,1.0,,Due to pandemic challenges and consideration of a different study design in the future.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,INDUSTRY,,,,,,,2024,0.0
NCT04848220,,2021-04-14,2023-08-18,,2023-11-23,2021-04-14,2021-04-19,ACTUAL,2023-11-23,2023-12-12,ACTUAL,,,,2023-11-23,2023-12-12,ACTUAL,2021-05-20,ACTUAL,2021-05-20,2023-11,2023-11-30,2022-08-31,ACTUAL,2022-08-31,2022-08-23,ACTUAL,2022-08-23,,INTERVENTIONAL,,"Full analysis set (FAS) included all randomized participants, irrespective of whether they received any study treatment.","A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention","A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Effect on Microvascular Obstruction of Temanogrel in Subjects Undergoing Percutaneous Coronary Intervention",TERMINATED,,PHASE2,29.0,ACTUAL,Pfizer,This study was terminated early due to a business decision that was not due to any safety concerns. The number of participants was smaller than originally planned and only summary statistics were therefore generated for primary and secondary outcome measures.,3.0,,Business decision,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,INDUSTRY,,,,,,,2022,0.0
NCT04371107,,2020-04-27,,,2023-03-17,2020-04-30,2020-05-01,ACTUAL,,,,,,,2023-03-17,2023-03-21,ACTUAL,2020-04-29,ACTUAL,2020-04-29,2023-03,2023-03-31,2023-07-01,ESTIMATED,2023-07-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,AMBU-COVID,,Proactive Care of Ambulatory COVID19 Patients,Proactive Care of Ambulatory COVID19 Patients: Open-labeled Randomized Trial,SUSPENDED,,PHASE3,11.0,ACTUAL,"Centre Hospitalier Universitaire, Amiens",,2.0,,ANSM notifications,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,OTHER,,,,,,,2023,0.0
NCT04371185,,2020-03-23,,,2021-09-09,2020-04-29,2020-05-01,ACTUAL,,,,,,,2021-09-09,2021-09-13,ACTUAL,2020-08-08,ACTUAL,2020-08-08,2021-09,2021-09-30,2021-04-19,ACTUAL,2021-04-19,2021-04-19,ACTUAL,2021-04-19,,INTERVENTIONAL,,,Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara® in Healthy Subjects,"A Randomized, Double-blinded, Single-dose, 3-arms Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT2206 Injection vs Ustekinumab Injection (Stelara) in Healthy Chinese Male Subjects",COMPLETED,,PHASE1,270.0,ACTUAL,Bio-Thera Solutions,,3.0,,,f,,,,,f,f,,,,,,,,,NO,Only one site study,2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,INDUSTRY,,,,,,,2021,1.0
NCT02684058,,2016-02-04,2023-04-13,2022-07-25,2023-11-20,2016-02-11,2016-02-17,ESTIMATED,2023-05-18,2023-05-19,ACTUAL,2022-08-10,2022-08-11,ACTUAL,2023-11-20,2023-12-13,ACTUAL,2017-12-28,ACTUAL,2017-12-28,2023-11,2023-11-30,2023-04-28,ACTUAL,2023-04-28,2021-08-23,ACTUAL,2021-08-23,,INTERVENTIONAL,,,Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors,Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib in Combination With Trametinib in Children and Adolescent Patients With BRAF V600 Mutation Positive Low Grade Glioma (LGG) or Relapsed or Refractory High Grade Glioma (HGG),COMPLETED,,PHASE2,151.0,ACTUAL,Novartis,,3.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-14 23:29:48.39383,2024-10-14 23:29:48.39383,INDUSTRY,,,,,,,2023,1.0
NCT04592159,,2020-10-07,,,2022-06-02,2020-10-16,2020-10-19,ACTUAL,,,,,,,2022-06-02,2022-06-03,ACTUAL,2021-02-01,ESTIMATED,2021-02-01,2022-06,2022-06-30,2023-03,ESTIMATED,2023-03-31,2023-03,ESTIMATED,2023-03-31,,INTERVENTIONAL,,,Study of the Safety and Efficacy of Nabiximols Oromucosal Spray Versus Placebo in Patients With Post-traumatic Stress Disorder,"A Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of Nabiximols Oromucosal Spray Versus Placebo in Patients With Post-traumatic Stress Disorder",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Jazz Pharmaceuticals,,2.0,,The decision to suspend this study was based upon evaluation of pandemic-related challenges impacting both clinical trial sites and potential participants. This suspension was initiated prior to site activation and participant recruitment.,f,,,,,f,f,,,f,,,,,,NO,,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,INDUSTRY,,,,,,,2023,0.0
NCT03221166,,2017-07-05,,,2020-09-02,2017-07-14,2017-07-18,ACTUAL,,,,,,,2020-09-02,2020-09-04,ACTUAL,2018-02-27,ACTUAL,2018-02-27,2020-09,2020-09-30,2020-07-31,ACTUAL,2020-07-31,2020-07-31,ACTUAL,2020-07-31,,INTERVENTIONAL,,,Thalidomide Versus Infliximab in New Onset Crohn's Disease With Poor Prognostic Factors,"Thalidomide, a Novel Immunological Treatment to Modify the Natural History of Paediatric Crohn's Disease: a New Proposal From a Well-established Paediatric Research Network",TERMINATED,,PHASE3,9.0,ACTUAL,IRCCS Burlo Garofolo,,2.0,,Difficulty in recruiting subjects who meet the inclusion/exclusion criteria,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 23:58:19.95904,2024-10-15 23:58:19.95904,OTHER,,,,,,,2020,0.0
NCT02295501,,2014-11-04,,,2021-03-26,2014-11-17,2014-11-20,ESTIMATED,,,,,,,2021-03-26,2021-03-29,ACTUAL,2014-12,,2014-12-31,2021-03,2021-03-31,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,,,"A Prospective, Open Label, Phase 1 Safety Study of Passive Immune Therapy During Acute Ebola Virus Disease Using Transfusion of INTERCEPT Plasma Prepared From Volunteer Donors Who Have Recovered From Ebola Virus Disease","A Prospective, Open Label Observational, Phase 1 Safety Study of Passive Immune Therapy During Acute Ebola Virus Disease Using Transfusion of INTERCEPT Plasma Prepared From Volunteer Donors Who Have Recovered From Ebola Virus Disease",TERMINATED,,PHASE1,6.0,ACTUAL,Cerus Corporation,,1.0,,The study was terminated on expiry of the frozen and stored plasma components.,f,,,,f,,,,,,,,,,,,,2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,INDUSTRY,,,,,,,2020,0.0
NCT04657666,,2020-11-11,2023-04-26,,2023-07-14,2020-12-01,2020-12-08,ACTUAL,2023-07-14,2023-07-20,ACTUAL,,,,2023-07-14,2023-07-20,ACTUAL,2020-12-21,ACTUAL,2020-12-21,2023-07,2023-07-31,2022-05-10,ACTUAL,2022-05-10,2022-05-04,ACTUAL,2022-05-04,,INTERVENTIONAL,RELEASE MSS1,Baseline demographics were assessed in the Full Analysis Set.,Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis,"A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients With Multiple Sclerosis",COMPLETED,,PHASE3,68.0,ACTUAL,Jazz Pharmaceuticals,,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,INDUSTRY,,,,,,,2022,1.0
NCT02955212,,2016-11-02,2020-07-27,,2021-08-30,2016-11-02,2016-11-04,ESTIMATED,2020-07-27,2020-08-06,ACTUAL,,,,2021-08-30,2021-09-27,ACTUAL,2018-01-03,ACTUAL,2018-01-03,2021-08,2021-08-31,2020-09-03,ACTUAL,2020-09-03,2019-08-14,ACTUAL,2019-08-14,,INTERVENTIONAL,,The Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.,A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs),"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)",COMPLETED,,PHASE3,338.0,ACTUAL,AbbVie,,2.0,,,f,,,,t,t,f,,,t,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 20:16:06.802074,2024-10-16 20:16:06.802074,INDUSTRY,,,,,,,2020,1.0
NCT01974440,,2013-10-28,2023-03-23,,2024-08-07,2013-10-28,2013-11-01,ESTIMATED,2023-03-23,2023-04-14,ACTUAL,,,,2024-08-07,2024-08-09,ACTUAL,2014-01-31,ACTUAL,2014-01-31,2024-08,2024-08-31,2023-06-21,ACTUAL,2023-06-21,2022-05-30,ACTUAL,2022-05-30,,INTERVENTIONAL,SELENE,,"A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma","A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL)",COMPLETED,,PHASE3,403.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,,f,,,,t,,f,,,,,,,,,,,2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,INDUSTRY,,,,,,,2023,1.0
NCT04987762,,2021-07-15,2023-04-26,,2023-07-31,2021-08-02,2021-08-03,ACTUAL,2023-07-31,2023-08-22,ACTUAL,,,,2023-07-31,2023-08-22,ACTUAL,2021-08-03,ACTUAL,2021-08-03,2023-07,2023-07-31,2022-04-27,ACTUAL,2022-04-27,2022-04-27,ACTUAL,2022-04-27,,INTERVENTIONAL,,,Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children,"An Open-Label, Multicenter, Multiple-Dose, Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children 4 to 12 Years of Age",TERMINATED,,PHASE4,103.0,ACTUAL,Purdue Pharma LP,Study terminated early - only safety data collected until termination are presented.,1.0,,due to administrative reasons not related to efficacy or safety.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,INDUSTRY,,,,,,,2022,0.0
NCT05191472,,2022-01-02,,,2024-01-17,2022-01-02,2022-01-13,ACTUAL,,,,,,,2024-01-17,2024-01-19,ACTUAL,2022-05-03,ACTUAL,2022-05-03,2024-01,2024-01-31,2023-12-31,ACTUAL,2023-12-31,2023-12-31,ACTUAL,2023-12-31,,INTERVENTIONAL,,,Pembrolizumab for the Treatment of Relapsed or Refractory Multiple Myeloma After Anti-BCMA CAR-T Therapies,Phase II Study of Pembrolizumab in Multiple Myeloma Patients Relapsing After or Refractory to Anti-BCMA CAR-T Therapies,TERMINATED,,PHASE2,3.0,ACTUAL,"University of California, San Francisco",,1.0,,Low Accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,OTHER,,,,,,,2023,0.0
NCT05694013,,2022-12-20,,,2024-07-08,2023-01-19,2023-01-23,ACTUAL,,,,,,,2024-07-08,2024-07-10,ACTUAL,2023-02-27,ACTUAL,2023-02-27,2024-07,2024-07-31,2024-07-04,ACTUAL,2024-07-04,2024-07-04,ACTUAL,2024-07-04,,INTERVENTIONAL,ORIGAMA,,Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice,Interventional Platform Study Investigating the Impact of Digital Health Solutions on Health Outcomes and Health-Care Resource Utilization in Participants Receiving Systemic Treatment in Clinical Practice,TERMINATED,,PHASE2/PHASE3,49.0,ACTUAL,Hoffmann-La Roche,,3.0,,Study terminated by sponsor.,f,,,,,f,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,INDUSTRY,,,,,,,2024,0.0
NCT05411575,,2022-05-15,,,2023-04-07,2022-06-07,2022-06-09,ACTUAL,,,,,,,2023-04-07,2023-04-10,ACTUAL,2022-07-19,ESTIMATED,2022-07-19,2023-04,2023-04-30,2022-10,ESTIMATED,2022-10-31,2022-10,ESTIMATED,2022-10-31,,INTERVENTIONAL,LEONARDO,,Plerixafor in Acute Respiratory Distress Syndrome Related to COVID-19 (Phase IIb),"A Randomized, Double-blind, Placebo-controlled, Two Parallel Groups, International Multicenter Trial to Evaluate the Effect of Plerixafor in Acute Respiratory Failure Related to COVID-19.",WITHDRAWN,,PHASE2,0.0,ACTUAL,4P-Pharma,,2.0,,No participants Enrolled,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,INDUSTRY,,,,,,,2022,0.0
NCT03644342,,2018-06-04,2024-02-12,,2024-08-14,2018-08-21,2018-08-23,ACTUAL,2024-05-22,2024-06-18,ACTUAL,,,,2024-08-14,2024-09-03,ACTUAL,2019-07-15,ACTUAL,2019-07-15,2024-08,2024-08-31,2023-09-27,ACTUAL,2023-09-27,2022-04-18,ACTUAL,2022-04-18,,INTERVENTIONAL,NIVIX,,Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix,Phase I/II Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix,TERMINATED,,PHASE1/PHASE2,4.0,ACTUAL,Baylor College of Medicine,,2.0,,A recent change in treatment landscape may make study futile,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2023,0.0
NCT04964050,,2021-07-06,,,2023-01-25,2021-07-06,2021-07-15,ACTUAL,,,,,,,2023-01-25,2023-01-27,ACTUAL,2022-04-21,ESTIMATED,2022-04-21,2023-01,2023-01-31,2022-05-26,ESTIMATED,2022-05-26,2022-05-26,ESTIMATED,2022-05-26,,INTERVENTIONAL,,,A Bioequivalence Study Between Capozide Versus ACE-Hemmer-ratiopharm in Healthy Adult Participants Under Fasting Conditions,"An Open-label, Randomized Three Period, Three Sequence, Partially Replicated Crossover Bioequivalence Study of Two Oral Formulations of Captopril/Hydrochlorothiazide 50/25 mg Tablets in Healthy Adult Participants Under Fasting Conditions",WITHDRAWN,,PHASE1,0.0,ACTUAL,GlaxoSmithKline,,3.0,,Internal sponsor decision to terminate project prematurely based on a waiver granted by Egypt EDA (Egyptian drug authority). No subjects were enrolled.,f,,,,f,f,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2022,0.0
NCT03925675,,2019-04-19,,,2024-08-29,2019-04-19,2019-04-24,ACTUAL,,,,,,,2024-08-29,2024-09-03,ACTUAL,2020-08-24,ESTIMATED,2020-08-24,2024-08,2024-08-31,2023-08-31,ACTUAL,2023-08-31,2023-08-31,ACTUAL,2023-08-31,,INTERVENTIONAL,,,18F-Fluciclovine PET and Multiparametric MR Imaging,Differentiating Brain Tumor Recurrence From Treatment-Induced Necrosis Using 18F-Fluciclovine (Anti-18f-facbc) PET and Multiparametric MR Imaging,WITHDRAWN,,PHASE2,0.0,ACTUAL,Loma Linda University,,1.0,,No subjects enrolled,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2023,0.0
NCT05215951,,2021-11-15,,,2023-04-04,2022-01-18,2022-01-31,ACTUAL,,,,,,,2023-04-04,2023-04-06,ACTUAL,2022-07-06,ACTUAL,2022-07-06,2023-03,2023-03-31,2023-03-09,ACTUAL,2023-03-09,2023-03-09,ACTUAL,2023-03-09,,INTERVENTIONAL,MINOVA,,Osimertinib Plus Chemotherapy in Uncommon EGFRm NSCLC,"The Efficacy and Safety of Osimertinib With Platinum Plus Pemetrexed Chemotherapy as First-line Treatment in Advanced Non-small Cell Lung Cancer Patients With Uncommon Epidermal Growth Factor Receptor Mutations: A phase2, Open Label, Single Arm, Multicenter, Exploratory Study",TERMINATED,,PHASE2,5.0,ACTUAL,AstraZeneca,,1.0,,Enrollment delay study timeline seriously.,f,,,,,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2023,0.0
NCT03750760,,2018-11-19,,,2019-06-11,2018-11-20,2018-11-23,ACTUAL,,,,,,,2019-06-11,2019-06-13,ACTUAL,2020-01,ESTIMATED,2020-01-31,2019-06,2019-06-30,2021-12,ESTIMATED,2021-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,EARLY,,Early Alirocumab to Reduce LDL-C in Myocardial Infarction,Early Alirocumab to Reduce LDL-C in Myocardial Infarction,WITHDRAWN,,PHASE4,0.0,ACTUAL,Imperial College London,,2.0,,Changes in funding decision,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,OTHER,,,,,,,2021,0.0
NCT02685735,,2015-06-01,2023-03-09,,2023-10-03,2016-02-15,2016-02-19,ESTIMATED,2023-10-03,2023-10-04,ACTUAL,,,,2023-10-03,2023-10-04,ACTUAL,2016-06-02,ACTUAL,2016-06-02,2023-05,2023-05-31,2022-02-09,ACTUAL,2022-02-09,2022-02-09,ACTUAL,2022-02-09,,INTERVENTIONAL,,,"Predicting, Understanding and Speeding Recovery After TKA","Predicting, Understanding, and Speeding Recovery After Total Knee Arthroplasty",TERMINATED,,PHASE4,350.0,ACTUAL,Wake Forest University Health Sciences,The trial was terminated early because of depletion of funding. Power analysis was based on 250 subjects and only 208 (83% of proposed total) were studied before termination of funding.,2.0,,lack of continued funding support,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2022,0.0
NCT02805894,,2016-06-10,,,2021-05-05,2016-06-15,2016-06-20,ESTIMATED,,,,,,,2021-05-05,2021-05-10,ACTUAL,2017-11-15,ACTUAL,2017-11-15,2021-05,2021-05-31,2020-03-19,ACTUAL,2020-03-19,2020-03-19,ACTUAL,2020-03-19,,INTERVENTIONAL,,,NBTXR3 Nanoparticles and EBRT or EBRT With Brachytherapy in the Treatment of Prostate Adenocarcinoma,A Phase I-II Dose-escalation Study of NBTXR3 Activated by EBRT or EBRT With Brachytherapy in Patients With Newly Diagnosed Unfavorable Intermediate or High Risk Prostate Adenocarcinoma Treated With Androgen Deprivation,TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,Nanobiotix,,2.0,,Prostate cancer treatment has greatly changed since the initiation of this trial and therefore we have stopped this trial to allow for further evaluation of the treatment landscape,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,INDUSTRY,,,,,,,2020,0.0
NCT04324021,,2020-03-25,2021-11-29,,2022-03-03,2020-03-25,2020-03-27,ACTUAL,2022-03-03,2022-03-10,ACTUAL,,,,2022-03-03,2022-03-10,ACTUAL,2020-04-02,ACTUAL,2020-04-02,2022-03,2022-03-31,2020-11-13,ACTUAL,2020-11-13,2020-11-13,ACTUAL,2020-11-13,,INTERVENTIONAL,,,Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection.,"A Phase 2/3, Randomized, Open-label, Parallel Group, 3-arm, Multicenter Study Investigating the Efficacy and Safety of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and Anakinra, an Interleukin-1(IL-1) Receptor Antagonist, Versus Standard of Care, in Reducing Hyper-inflammation and Respiratory Distress in Patients With SARS-CoV-2 Infection.",TERMINATED,,PHASE2/PHASE3,16.0,ACTUAL,Swedish Orphan Biovitrum,,3.0,,Standard of care evolved during the timeframe of the study and had critical impact on recruitment.~Early termination was not based on safety reasons but due to the reasons mentoined above.~The ongoing patients were completed.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2020,0.0
NCT03334435,,2017-11-03,2022-04-14,,2024-08-30,2017-11-03,2017-11-07,ACTUAL,2022-06-07,2022-07-01,ACTUAL,,,,2024-08-30,2024-09-03,ACTUAL,2018-03-28,ACTUAL,2018-03-28,2024-08,2024-08-31,2023-07-12,ACTUAL,2023-07-12,2020-09-21,ACTUAL,2020-09-21,,INTERVENTIONAL,BREEZE-AD3,Modified Intent-to-treat Population: All participants who received at least one dose of investigational product (IP) in JAHN.,A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis,"A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis",COMPLETED,,PHASE3,1645.0,ACTUAL,Eli Lilly and Company,,16.0,,,f,,,,t,t,f,,,,,,,,,YES,Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.~This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2023,1.0
NCT03648229,,2018-08-14,,,2021-06-17,2018-08-23,2018-08-27,ACTUAL,,,,,,,2021-06-17,2021-06-21,ACTUAL,2019-09-01,ESTIMATED,2019-09-01,2021-06,2021-06-30,2024-06-30,ESTIMATED,2024-06-30,2022-06-30,ESTIMATED,2022-06-30,,INTERVENTIONAL,AGLT,,African Glaucoma Laser Trial,African Glaucoma Laser Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,West Virginia University,,3.0,,Funding unavailable,f,,,,t,t,f,,,t,,,,,,NO,To be determined by NIH Data Sharing Policy,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2024,0.0
NCT04176991,,2019-11-14,,,2020-11-09,2019-11-22,2019-11-26,ACTUAL,,,,,,,2020-11-09,2020-11-12,ACTUAL,2019-12-11,ACTUAL,2019-12-11,2020-11,2020-11-30,2020-10-31,ACTUAL,2020-10-31,2020-10-31,ACTUAL,2020-10-31,,INTERVENTIONAL,,,Single Ascending Dose Study of CTI-1601 Versus Placebo in Subjects With Friedreich's Ataxia,"A Phase 1 Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CTI-1601 Versus Placebo in Subjects With Friedreich's Ataxia",COMPLETED,,PHASE1,28.0,ACTUAL,"Larimar Therapeutics, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,INDUSTRY,,,,,,,2020,1.0
NCT03806556,,2019-01-04,2021-07-27,,2021-08-24,2019-01-11,2019-01-16,ACTUAL,2021-08-24,2021-09-20,ACTUAL,,,,2021-08-24,2021-09-20,ACTUAL,2019-04-22,ACTUAL,2019-04-22,2021-08,2021-08-31,2020-08-25,ACTUAL,2020-08-25,2020-08-25,ACTUAL,2020-08-25,,INTERVENTIONAL,,,A Pediatric Trial Using Tranexamic Acid in Thrombocytopenia,A Pediatric Trial Using Tranexamic Acid in Thrombocytopenia,TERMINATED,,PHASE1/PHASE2,11.0,ACTUAL,University of Pittsburgh,"The pre-specified analysis described in the study protocol stated the following: For secondary endpoints, events of WHO Grade 2 or higher bleeding will be compared through the use of odds ratio or T-test statistic of means. The mean number of platelet transfusions will be analyzed using a T-test statistic of means. This analysis was not completed as it would be scientifically inappropriate due to insufficient enrollment. Instead a descriptive analysis was completed.",2.0,,"Low accrual rate, strategic reasons",f,,,,t,t,f,,,,,,Beginning within 1 year and ending 5 years after trial completion,Researchers who provide a methodologically sound proposal may request data. Proposals should be directed to meghan.mccormick3@chp.edu. To gain access data requestors will need to sign a data access agreement.,,YES,Anonymized public data set will be available after publication of primary results,2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,OTHER,,,,,,,2020,0.0
NCT03135262,,2017-04-26,2021-04-26,,2021-12-05,2017-04-26,2017-05-01,ACTUAL,2021-07-06,2021-07-27,ACTUAL,,,,2021-12-05,2021-12-07,ACTUAL,2017-06-15,ACTUAL,2017-06-15,2021-12,2021-12-31,2020-04-30,ACTUAL,2020-04-30,2020-04-30,ACTUAL,2020-04-30,,INTERVENTIONAL,,,A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL),A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Patients With Relapsed or Refractory Follicular Lymphoma and Obinutuzumab or Rituximab in Combination With Idasanutlin and Venetoclax in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma,TERMINATED,,PHASE1/PHASE2,29.0,ACTUAL,Hoffmann-La Roche,Dose expansion part of the study did not take place. AEs were not differentiated for DLBCL and FL arms since these are sub mutations of disease which does nor show differences in AEs.,4.0,,Sponsor's decision to terminate the study after Phase 1; will not proceed with Phase 2.,f,,,,,t,f,,,,,,,,,,,2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,INDUSTRY,,,,,,,2020,0.0
NCT04595370,,2020-10-14,,,2023-10-23,2020-10-14,2020-10-20,ACTUAL,,,,,,,2023-10-23,2023-10-24,ACTUAL,2021-01-26,ACTUAL,2021-01-26,2023-10,2023-10-31,2023-09-22,ACTUAL,2023-09-22,2023-09-22,ACTUAL,2023-09-22,,INTERVENTIONAL,MIRACLE,,"Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease","A Phase 2b, Randomised, Double-Blind, Active Controlled, Multi Centre Study to Evaluate the Efficacy, Safety and Tolerability of Oral AZD9977 and Dapagliflozin Treatment in Patients With Heart Failure and Chronic Kidney Disease",COMPLETED,,PHASE2,153.0,ACTUAL,AstraZeneca,,4.0,,,,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,INDUSTRY,,,,,,,2023,1.0
NCT03727789,,2018-10-12,,,2024-03-25,2018-10-31,2018-11-01,ACTUAL,,,,,,,2024-03-25,2024-03-27,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2024-03,2024-03-31,2024-01-16,ACTUAL,2024-01-16,2024-01-16,ACTUAL,2024-01-16,,INTERVENTIONAL,,,CBL0137 in Treating Patients With Advanced Extremity Melanoma or Sarcoma,"A Single-Center Phase I Dose Escalation/Response Trial to Evaluate Safety, Tolerability, and Anti-Tumor Efficacy of Intra-Arterial CBL0137 for Patients With Advanced Extremity Melanoma or Sarcoma",TERMINATED,,PHASE1,7.0,ACTUAL,Roswell Park Cancer Institute,,1.0,,low accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2024,0.0
NCT04838054,,2021-04-04,2021-05-24,,2022-03-22,2021-04-06,2021-04-08,ACTUAL,2022-03-22,2022-04-14,ACTUAL,,,,2022-03-22,2022-04-14,ACTUAL,2018-03-15,ACTUAL,2018-03-15,2022-03,2022-03-31,2020-03-04,ACTUAL,2020-03-04,2020-01-15,ACTUAL,2020-01-15,,INTERVENTIONAL,,The focus of the analysis is on the teeth. The study will evaluate the outcome for all teeth as well as compare the outcomes between teeth and implants.,The Efficacy of Stabilized Chlorine Dioxide Rinse as a Chemical Adjuvant for Treatment of Per-implant Mucositis,Pilot Study: The Efficacy of Stabilized Chlorine Dioxide Rinse as a Chemical Adjuvant for Treatment of Peri-implant Mucositis,COMPLETED,,PHASE4,57.0,ACTUAL,"Rowpar Pharmaceuticals, Inc.",,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,INDUSTRY,,,,,,,2020,1.0
NCT04105010,,2019-09-18,,,2024-04-16,2019-09-24,2019-09-26,ACTUAL,,,,,,,2024-04-16,2024-04-17,ACTUAL,2019-09-10,ACTUAL,2019-09-10,2024-02,2024-02-29,2024-02-22,ACTUAL,2024-02-22,2023-10-12,ACTUAL,2023-10-12,,INTERVENTIONAL,,,"Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)","A Phase I/II, Open-Label, Multicentre Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD4205 in Patients With Peripheral T Cell Lymphoma (PTCL)",COMPLETED,,PHASE2,171.0,ACTUAL,Dizal Pharmaceuticals,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2024,1.0
NCT02952586,,2016-10-31,2020-12-21,,2021-09-20,2016-10-31,2016-11-02,ESTIMATED,2021-02-08,2021-02-24,ACTUAL,,,,2021-09-20,2021-09-22,ACTUAL,2016-11-28,ACTUAL,2016-11-28,2021-09,2021-09-30,2020-08-25,ACTUAL,2020-08-25,2019-12-23,ACTUAL,2019-12-23,,INTERVENTIONAL,,The full analysis set (FAS) included all randomized participants.,Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100),A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF AVELUMAB IN COMBINATION WITH STANDARD OF CARE CHEMORADIOTHERAPY (CISPLATIN PLUS DEFINITIVE RADIATION THERAPY) VERSUS STANDARD OF CARE CHEMORADIOTHERAPY IN THE FRONT-LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK,TERMINATED,,PHASE3,697.0,ACTUAL,Pfizer,,2.0,,The trial prematurely terminated as recommended by the E-DMC because the boundary for futility has been crossed.,f,,,,t,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2020,0.0
NCT05129280,,2021-11-19,,,2023-08-02,2021-11-19,2021-11-22,ACTUAL,,,,,,,2023-08-02,2023-08-04,ACTUAL,2022-01-25,ACTUAL,2022-01-25,2023-08,2023-08-31,2023-07-12,ACTUAL,2023-07-12,2023-07-12,ACTUAL,2023-07-12,,INTERVENTIONAL,,,"A Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid Tumors","An Open-label, Multicenter, Phase I Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid Tumors",TERMINATED,,PHASE1,23.0,ACTUAL,Hoffmann-La Roche,,3.0,,The study was terminated due to program discontinuation.,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,INDUSTRY,,,,,,,2023,0.0
NCT04490486,,2020-07-27,,,2022-05-06,2020-07-28,2020-07-29,ACTUAL,,,,,,,2022-05-06,2022-05-12,ACTUAL,2022-10-01,ESTIMATED,2022-10-01,2022-05,2022-05-31,2024-06-01,ESTIMATED,2024-06-01,2024-06-01,ESTIMATED,2024-06-01,,INTERVENTIONAL,COVID-19,,Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Placebo to Treat Acute Pulmonary Inflammation Due to COVID-19,"Phase I, Randomized, Double Blinded, Placebo Control Study to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Placebo to Treat Acute Pulmonary Inflammation Due to COVID-19 With Moderate to Severe Symptoms",WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Miami,,2.0,,Not Funded,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,OTHER,,,,,,,2024,0.0
NCT03668808,,2018-09-11,2022-01-24,,2022-10-06,2018-09-11,2018-09-13,ACTUAL,2022-05-05,2022-06-02,ACTUAL,,,,2022-10-06,2022-11-01,ACTUAL,2018-11-16,ACTUAL,2018-11-16,2022-10,2022-10-31,2020-09-19,ACTUAL,2020-09-19,2020-09-19,ACTUAL,2020-09-19,,INTERVENTIONAL,SafrTravlT1D,Subjects randomly assigned to one arm and then crossed over to the other arm when the first was completed.,Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones.,Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Travelling Across Multiple Time Zones. A Pilot Study.,COMPLETED,,PHASE4,25.0,ACTUAL,Sansum Diabetes Research Institute,,2.0,,,f,,,,t,t,t,,,t,,,,,,UNDECIDED,Undecided to whether to make individual participant data available.,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2020,1.0
NCT04095793,,2019-08-01,2022-11-07,,2022-11-07,2019-09-17,2019-09-19,ACTUAL,2022-11-07,2022-11-30,ACTUAL,,,,2022-11-07,2022-11-30,ACTUAL,2019-09-19,ACTUAL,2019-09-19,2022-11,2022-11-30,2021-11-12,ACTUAL,2021-11-12,2021-11-12,ACTUAL,2021-11-12,,INTERVENTIONAL,OAK,The safety analysis set was defined as all enrolled participants who have received at least one dose of ampreloxetine in this study.,Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure,"A Phase 3, 182-week, Open-Label, Extension Study to Investigate the Safety and Tolerability of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (Symptomatic nOH) in Subjects With Primary Autonomic Failure",TERMINATED,,PHASE3,110.0,ACTUAL,Theravance Biopharma,"Because the study was terminated early by the Sponsor, the latest scheduled study visit completed by any participant was at Week 98.",1.0,,Stopped early due to company decision. Company decision based on analysis results in TD-9855-0169.,f,,,,t,t,f,,,,,,,,,NO,"Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.",2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,INDUSTRY,,,,,,,2021,0.0
NCT05345938,,2022-04-06,,,2024-02-22,2022-04-19,2022-04-26,ACTUAL,,,,,,,2024-02-22,2024-02-23,ACTUAL,2022-06-14,ACTUAL,2022-06-14,2022-01,2022-01-31,2022-11-19,ACTUAL,2022-11-19,2022-11-19,ACTUAL,2022-11-19,,INTERVENTIONAL,,,A Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Acute Myeloid Leukemia,"A Phase I/II Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Acute Myeloid Leukemia",TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.",,1.0,,Adjust the research strategy.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 09:51:51.761595,2024-10-16 09:51:51.761595,INDUSTRY,,,,,,,2022,0.0
NCT04260529,,2020-02-05,,,2024-07-23,2020-02-05,2020-02-07,ACTUAL,,,,,,,2024-07-23,2024-07-24,ACTUAL,2020-04-30,ACTUAL,2020-04-30,2024-07,2024-07-31,2024-07-05,ACTUAL,2024-07-05,2024-07-05,ACTUAL,2024-07-05,,INTERVENTIONAL,CICILIA,,CyPep-1 Injections in Cancer Inducing Lymphocyte Infiltrate Accumulations,"A First-in-human, Open-label Dose Escalation Followed by Dose Expansion Phase I/IIa Trial to Evaluate the Safety, Preliminary Efficacy and Pharmacokinetics of Intratumoral CyPep-1 Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Cancers.",COMPLETED,,PHASE1/PHASE2,60.0,ACTUAL,Cytovation AS,,4.0,,,f,,,,t,f,f,,,,,,Within 6 months of study completion,,,YES,De-identified data for all primary and secondary outcomes will be made available.,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,INDUSTRY,,,,,,,2024,1.0
NCT03106428,,2017-03-29,,,2020-02-27,2017-04-03,2017-04-10,ACTUAL,,,,,,,2020-02-27,2020-02-28,ACTUAL,2017-03-29,ACTUAL,2017-03-29,2020-02,2020-02-29,2020-01-03,ACTUAL,2020-01-03,2020-01-03,ACTUAL,2020-01-03,,INTERVENTIONAL,,,A Multiple Ascending Dose Study of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies,"A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies",COMPLETED,,PHASE1,67.0,ACTUAL,MedImmune LLC,,3.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2020,0.0
NCT04683224,,2020-12-10,,,2022-03-21,2020-12-23,2020-12-24,ACTUAL,,,,,,,2022-03-21,2022-04-04,ACTUAL,2021-02-01,ESTIMATED,2021-02-01,2022-03,2022-03-31,2023-03-22,ESTIMATED,2023-03-22,2023-03-22,ESTIMATED,2023-03-22,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Immunogenicity, and Efficacy of UB-612 COVID-19 Vaccine","A Phase 2/3 Randomized, Multicenter, Double-Blind, Placebo Controlled, Dose-Response Study to Evaluate the Safety, Immunogenicity, and Efficacy of UB-612 Vaccine in Adults",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,"Vaxxinity, Inc.",,8.0,,Study was withdrawn due to redesign of the protocol.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2023,0.0
NCT03737448,,2018-11-07,,,2021-03-02,2018-11-07,2018-11-09,ACTUAL,,,,,,,2021-03-02,2021-03-04,ACTUAL,2018-11-28,ACTUAL,2018-11-28,2021-03,2021-03-31,2021-06-30,ESTIMATED,2021-06-30,2021-06-30,ESTIMATED,2021-06-30,,INTERVENTIONAL,TRUST,,TRimetazidine for acUte on Chronic Liver Failure STudy,"A Phase 1b Open-Label Study Assessing the Pharmacokinetics, Tolerability, and Safety of Oral Trimetazidine in Subjects With Acute-on-Chronic Liver Failure",SUSPENDED,,PHASE1,30.0,ESTIMATED,Martin Pharmaceuticals,,2.0,,Lack of enrollment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,INDUSTRY,,,,,,,2021,0.0
NCT02912182,,2016-09-15,,,2021-09-02,2016-09-20,2016-09-23,ESTIMATED,,,,,,,2021-09-02,2021-09-10,ACTUAL,2015-12,,2015-12-31,2021-09,2021-09-30,2021-03-01,ACTUAL,2021-03-01,2021-03-01,ACTUAL,2021-03-01,,INTERVENTIONAL,,,Acute Unilateral Vestibulopathy and Corticosteroid Treatment,Acute Unilateral Vestibulopathy and Corticosteroid Treatment,TERMINATED,,PHASE4,78.0,ACTUAL,Lund University,,3.0,,Placebo medication expired,f,,,,t,,,,,,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2021,0.0
NCT01642004,,2012-07-09,2016-02-19,2015-11-17,2022-11-22,2012-07-16,2012-07-17,ESTIMATED,2016-02-19,2016-03-17,ESTIMATED,2015-11-17,2015-12-16,ESTIMATED,2022-11-22,2022-12-28,ACTUAL,2012-10-16,ACTUAL,2012-10-16,2022-11,2022-11-30,2021-08-16,ACTUAL,2021-08-16,2014-11-17,ACTUAL,2014-11-17,,INTERVENTIONAL,,All randomized participants,Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017),An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC),COMPLETED,,PHASE3,272.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,INDUSTRY,,,,,,,2021,1.0
NCT03074786,,2017-02-10,,,2017-09-05,2017-03-03,2017-03-09,ACTUAL,,,,,,,2017-09-05,2017-09-08,ACTUAL,2017-11,ESTIMATED,2017-11-30,2017-09,2017-09-30,2020-12-30,ESTIMATED,2020-12-30,2018-12,ESTIMATED,2018-12-31,,INTERVENTIONAL,,,Reversing the Epidemic in Africa With Choices in HIV Prevention (REACH),A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population,WITHDRAWN,,PHASE2,0.0,ACTUAL,"International Partnership for Microbicides, Inc.",,2.0,,Study was transferred to partner who will conduct under its own IND,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2020,0.0
NCT02220894,,2014-08-19,2019-02-14,,2023-10-06,2014-08-19,2014-08-20,ESTIMATED,2019-03-14,2019-03-15,ACTUAL,,,,2023-10-06,2023-10-10,ACTUAL,2014-10-30,ACTUAL,2014-10-30,2023-10,2023-10-31,2022-09-12,ACTUAL,2022-09-12,2018-09-04,ACTUAL,2018-09-04,,INTERVENTIONAL,,The Baseline Analysis Population consisted of all randomized participants who were alive at the time of randomization and had a Tumor Proportion Score (TPS) ≥1%.,Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042),"A Randomized, Open Label, Phase III Study of Overall Survival Comparing Pembrolizumab (MK-3475) Versus Platinum Based Chemotherapy in Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer (Keynote 042)",COMPLETED,,PHASE3,1274.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 14:13:07.075647,2024-10-15 14:13:07.075647,INDUSTRY,,,,,,,2022,1.0
NCT04269993,,2020-02-12,,,2024-01-08,2020-02-13,2020-02-17,ACTUAL,,,,,,,2024-01-08,2024-01-10,ACTUAL,2022-05-18,ACTUAL,2022-05-18,2024-01,2024-01-31,2023-07-31,ACTUAL,2023-07-31,2023-07-31,ACTUAL,2023-07-31,,INTERVENTIONAL,,,Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis,Impact of Acute Cannabis Administration on Pain Symptomology and Inflammatory Markers Among Patients With Rheumatoid or Psoriatic Arthritis,TERMINATED,,PHASE2,4.0,ACTUAL,Brown University,,2.0,,Termination of study funding,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2023,0.0
NCT03744247,,2018-11-14,,,2019-04-30,2018-11-14,2018-11-16,ACTUAL,,,,,,,2019-04-30,2019-05-02,ACTUAL,2019-04-21,ESTIMATED,2019-04-21,2019-03,2019-03-31,2021-06-01,ESTIMATED,2021-06-01,2021-01-01,ESTIMATED,2021-01-01,,INTERVENTIONAL,,,Lenvatinib Plus PD-1 Antibody Versus Lenvtinib Alone for Advanced HCC,Lenvatinib Plus Programmed Cell Death Protein-1 (PD-1) Inhibitor Versus Lenvtinib Alone for Advanced Hepatocellular Carcinoma: a Multicentre Randomised Controlled Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,Sun Yat-sen University,,2.0,,No paritcipants enrolled,f,,,,t,f,f,,,,,,,,,,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2021,0.0
NCT04542057,,2020-09-01,2023-06-19,,2023-10-02,2020-09-08,2020-09-09,ACTUAL,2023-07-21,2023-07-24,ACTUAL,,,,2023-10-02,2023-10-16,ACTUAL,2020-09-22,ACTUAL,2020-09-22,2023-10,2023-10-31,2022-07-06,ACTUAL,2022-07-06,2022-05-03,ACTUAL,2022-05-03,,INTERVENTIONAL,,All patients randomized set included all patients in the enrolled set who were randomized to study medication.,A Phase 3 Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD,"A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine Over 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease",COMPLETED,,PHASE3,790.0,ACTUAL,Verona Pharma plc,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2022,1.0
NCT03536884,,2018-05-14,2022-09-09,2020-09-11,2024-08-07,2018-05-14,2018-05-25,ACTUAL,2022-09-09,2022-10-10,ACTUAL,2020-09-11,2020-09-14,ACTUAL,2024-08-07,2024-09-03,ACTUAL,2018-06-13,ACTUAL,2018-06-13,2024-08,2024-08-31,2023-08-09,ACTUAL,2023-08-09,2019-09-12,ACTUAL,2019-09-12,,INTERVENTIONAL,BE RADIANT,Baseline Characteristics refer to the Randomized Set (RS) which consisted of all randomized study participants.,A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis,"A Multicenter, Randomized, Double-Blind, Secukinumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis",COMPLETED,,PHASE3,743.0,ACTUAL,UCB Pharma,,3.0,,,f,,,,t,t,f,,,f,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",https://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available",2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2023,1.0
NCT03896724,,2019-01-18,,,2023-09-06,2019-03-27,2019-04-01,ACTUAL,,,,,,,2023-09-06,2023-09-07,ACTUAL,2019-05-07,ACTUAL,2019-05-07,2023-09,2023-09-30,2023-07-07,ACTUAL,2023-07-07,2023-07-07,ACTUAL,2023-07-07,,INTERVENTIONAL,,,"Safety, Immunogenicity and Efficacy of R21 Matrix-M in 5-17 Month Old Children in Nanoro, Burkina Faso","A Phase Ib/IIb Randomised Controlled Trial of the Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine, R21 Adjuvanted With Matrix-M (R21/MM), in 5-17 Month Old Children in Nanoro, Burkina Faso",COMPLETED,,PHASE1/PHASE2,450.0,ACTUAL,University of Oxford,,3.0,,,f,,,,t,f,f,,,,,,Within 12 months of manuscripts related to the trial being published.,A link to the data respository will be given below,,YES,"Study information will be made available through an open repository. The information to be made available will be anonymized so that there is no link to participants and will include data on safety, immune responses and any other data generated from samples obtained in this study.",2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,OTHER,,,,,,,2023,1.0
NCT04625699,,2020-11-06,,,2023-06-02,2020-11-06,2020-11-12,ACTUAL,,,,,,,2023-06-02,2023-06-06,ACTUAL,2022-12,ESTIMATED,2022-12-31,2023-06,2023-06-30,2023-12,ESTIMATED,2023-12-31,2023-07,ESTIMATED,2023-07-31,,INTERVENTIONAL,,,Study of Durvalumab + Tremelimumab in NSCLC Patients After Adjuvant Treatment,A Feasibility Study of Durvalumab + Tremelimumab in Resected Non Small Cell Lung Cancer (NSCLC) Patients With Detectable Circulating Tumor DNA After Adjuvant Treatment,WITHDRAWN,,PHASE2,0.0,ACTUAL,Columbia University,,1.0,,Contract was never finalized.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,OTHER,,,,,,,2023,0.0
NCT02698111,,2016-02-29,,,2023-05-04,2016-02-29,2016-03-03,ESTIMATED,,,,,,,2023-05-04,2023-05-08,ACTUAL,2017-02-08,ACTUAL,2017-02-08,2022-11,2022-11-30,2021-10-20,ACTUAL,2021-10-20,2021-10-20,ACTUAL,2021-10-20,,INTERVENTIONAL,,,Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma,"Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma：an Open-label,Phase 1 Study.",TERMINATED,,PHASE1/PHASE2,20.0,ACTUAL,"Suzhou Zelgen Biopharmaceuticals Co.,Ltd",,1.0,,Corporate policy adjustments,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2021,0.0
NCT03555968,,2018-05-18,,,2022-04-20,2018-06-01,2018-06-14,ACTUAL,,,,,,,2022-04-20,2022-04-25,ACTUAL,2021-07,ESTIMATED,2021-07-31,2022-04,2022-04-30,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Effects of THC and Alcohol on Driving Performance,Determining the Combined Effects of THC and Alcohol on Driving Performance,WITHDRAWN,,PHASE4,0.0,ACTUAL,Lakehead University,,9.0,,Logistical issues,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,OTHER,,,,,,,2021,0.0
NCT03300427,,2017-09-28,2023-03-20,,2023-03-20,2017-09-28,2017-10-03,ACTUAL,2023-03-20,2024-01-05,ACTUAL,,,,2023-03-20,2024-01-05,ACTUAL,2018-07-05,ACTUAL,2018-07-05,2023-03,2023-03-31,2022-03-23,ACTUAL,2022-03-23,2022-03-23,ACTUAL,2022-03-23,,INTERVENTIONAL,TurkuPET,,The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients,Controlled Trial on the Short-term Effects of Sacubitril/Valsartan Therapy on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Patients With NYHA II-III Heart Failure and Reduced Systolic Function Using 11C-acetate Positron Emission Tomography and Echocardiography,COMPLETED,,PHASE4,55.0,ACTUAL,Novartis,,2.0,,,f,,,,f,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,INDUSTRY,,,,,,,2022,1.0
NCT03181789,,2017-06-06,2021-07-15,,2024-01-16,2017-06-07,2017-06-09,ACTUAL,2021-09-17,2021-10-14,ACTUAL,,,,2024-01-16,2024-02-07,ACTUAL,2017-10-18,ACTUAL,2017-10-18,2024-01,2024-01-31,2020-04-29,ACTUAL,2020-04-29,2019-10-25,ACTUAL,2019-10-25,,INTERVENTIONAL,HVTN119,,"Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA","A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA, in Healthy, HIV-Uninfected Adult Participants",COMPLETED,,PHASE1,56.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,4.0,,,f,,,,t,t,t,,,,,,,,,,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,NIH,,,,,,,2020,1.0
NCT02614261,,2015-11-23,2018-10-19,2018-03-15,2022-04-25,2015-11-23,2015-11-25,ESTIMATED,2018-12-12,2019-01-07,ACTUAL,2018-03-15,2018-03-19,ACTUAL,2022-04-25,2022-05-18,ACTUAL,2015-11-30,ACTUAL,2015-11-30,2022-04,2022-04-30,2021-07-14,ACTUAL,2021-07-14,2017-03-16,ACTUAL,2017-03-16,,INTERVENTIONAL,REGAIN,All randomized participants.,Evaluation of Galcanezumab in the Prevention of Chronic Migraine,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine - the REGAIN Study",COMPLETED,,PHASE3,1117.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,t,,,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,INDUSTRY,,,,,,,2021,1.0
NCT04311294,,2020-03-11,,,2021-05-20,2020-03-12,2020-03-17,ACTUAL,,,,,,,2021-05-20,2021-05-25,ACTUAL,2020-04,ESTIMATED,2020-04-30,2021-05,2021-05-31,2022-03,ESTIMATED,2022-03-31,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,,,Development of a Selective ALDH2 Inhibitor to Treat AUD,Development of a Selective ALDH2 Inhibitor for the Treatment of Alcohol Use Disorder,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, Los Angeles",,3.0,,Project was not funded.,f,,,,t,t,f,,,,,,,,,NO,"All data collected in this project will be shared (after appropriate de-identification) with the scientific community in a timely manner, in accordance with NIH Policy. Specifically, the dataset will be made available to the scientific community upon request and a data application will be required. These procedures are consistent with the recent NIAAA announcement: NOT-AA-18-010",2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2022,0.0
NCT04042051,,2019-07-31,,,2023-04-05,2019-07-31,2019-08-01,ACTUAL,,,,,,,2023-04-05,2023-04-06,ACTUAL,2019-11-12,ACTUAL,2019-11-12,2023-04,2023-04-30,2020-11-02,ACTUAL,2020-11-02,2020-11-02,ACTUAL,2020-11-02,,INTERVENTIONAL,Panthera,,Copanlisib in Combination With T-DM1 in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer,Phase Ib Clinical Trial of Copanlisib in Combination With Trastuzumab Emtansine (T-DM1) in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer Panthera,TERMINATED,,PHASE1,2.0,ACTUAL,Cancer Trials Ireland,,1.0,,Accrual rate to date was too low to finish the trial in a reasonable timeframe,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,NETWORK,,,,,,,2020,0.0
NCT04514510,,2020-08-14,2023-06-02,,2023-12-08,2020-08-14,2020-08-17,ACTUAL,2023-06-02,2023-06-27,ACTUAL,,,,2023-12-08,2024-01-02,ACTUAL,2020-11-02,ACTUAL,2020-11-02,2023-11,2023-11-30,2022-07-07,ACTUAL,2022-07-07,2022-06-13,ACTUAL,2022-06-13,,INTERVENTIONAL,,,Fixed Dose Flavonoid Isoquercetin on Thrombo-Inflammatory Biomarkers in Subjects With Stable Sickle Cell Disease,A Study to Evaluate the Effects of Fixed Dose Flavonoid Isoquercetin on Thrombo-Inflammatory Biomarkers in Subjects With Stable Sickle Cell Disease,COMPLETED,,PHASE2,46.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,NIH,,,,,,,2022,1.0
NCT01639339,,2012-07-10,2020-06-17,,2021-02-23,2012-07-10,2012-07-12,ESTIMATED,2020-06-17,2020-07-07,ACTUAL,,,,2021-02-23,2021-03-19,ACTUAL,2012-07-12,ACTUAL,2012-07-12,2021-02,2021-02-28,2020-03-12,ACTUAL,2020-03-12,2019-07-25,ACTUAL,2019-07-25,,INTERVENTIONAL,BLISS-LN,,Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab Plus Standard of Care Versus Placebo Plus Standard of Care in Adult Subjects With Active Lupus Nephritis",COMPLETED,,PHASE3,448.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,t,,,,,,,,IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,INDUSTRY,,,,,,,2020,1.0
NCT02565914,,2015-09-18,2020-05-28,,2023-09-01,2015-09-29,2015-10-01,ESTIMATED,2020-05-28,2020-06-16,ACTUAL,,,,2023-09-01,2023-09-28,ACTUAL,2015-08,ACTUAL,2015-08-31,2023-09,2023-09-30,2022-12-05,ACTUAL,2022-12-05,2019-05,ACTUAL,2019-05-31,,INTERVENTIONAL,,"Baseline data is based on the parent study baseline, which is defined as the most recent non-missing measurements collected before the first dose of the study drug in the treatment period of parent studies. Baseline data is presented for all participants who signed informed consent and enrolled, or dosed, in Part A, Part B, or Part C, respectively in this study.",A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation,"A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation",COMPLETED,,PHASE3,1131.0,ACTUAL,Vertex Pharmaceuticals Incorporated,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,INDUSTRY,,,,,,,2022,1.0
NCT04535453,,2020-08-27,2023-03-09,,2023-06-16,2020-08-27,2020-09-02,ACTUAL,2023-06-16,2023-06-22,ACTUAL,,,,2023-06-16,2023-06-22,ACTUAL,2020-08-28,ACTUAL,2020-08-28,2023-06,2023-06-30,2022-03-09,ACTUAL,2022-03-09,2022-03-09,ACTUAL,2022-03-09,,INTERVENTIONAL,,,A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults and Adolescents,"A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older and to Evaluate 2 Dose Levels of Ad26.COV2.S in Healthy Adolescents Aged 12 to 17 Years Inclusive",COMPLETED,,PHASE2,635.0,ACTUAL,Janssen Vaccines & Prevention B.V.,,4.0,,,t,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,INDUSTRY,,NCT04817657,NO_LONGER_AVAILABLE,,,,2022,1.0
NCT04981678,,2021-07-08,,,2023-12-14,2021-07-28,2021-07-29,ACTUAL,,,,,,,2023-12-14,2023-12-20,ACTUAL,2022-01-01,ACTUAL,2022-01-01,2023-12,2023-12-31,2023-10-16,ACTUAL,2023-10-16,2023-09-15,ACTUAL,2023-09-15,,INTERVENTIONAL,,,The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder,"A Prospective, Randomized Trial of the Effect of Buprenorphine Continuation Versus Dose Reduction on Pain Control and Post-Operative Opioid Use",TERMINATED,,PHASE4,12.0,ACTUAL,MaineHealth,,2.0,,This study was halted prior to accumulating the full number of participants due to difficulty in recruiting study subjects.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2023,0.0
NCT02534935,,2015-02-23,2018-02-19,,2021-08-30,2015-08-25,2015-08-28,ESTIMATED,2018-03-16,2018-04-17,ACTUAL,,,,2021-08-30,2021-09-27,ACTUAL,2015-08-31,ACTUAL,2015-08-31,2021-08,2021-08-31,2020-03-17,ACTUAL,2020-03-17,2017-08-21,ACTUAL,2017-08-21,,INTERVENTIONAL,,"Safety population included all participants who received at least 1 dose of the investigational product (rLP2086, HAV vaccine or saline) and had safety data available.","Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.","A PHASE 2, RANDOMIZED, CONTROLLED, OBSERVER-BLINDED STUDY CONDUCTED TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A NEISSERIA MENINGITIDIS SEROGROUP B BIVALENT RECOMBINANT LIPOPROTEIN 2086 VACCINE (BIVALENT RLP2086) WHEN ADMINISTERED TO HEALTHY TODDLERS AGED 12 TO <18 MONTHS OR 18 TO <24 MONTHS, AND THE SAFETY AND IMMUNOGENICITY OF A BOOSTER DOSE OF BIVALENT RLP2086",COMPLETED,,PHASE2,396.0,ACTUAL,Pfizer,"The immunogenicity data at 36 and 48 months after vaccination 3 was not collected due to change in planned analysis as per latest protocol amendment, according to which blood draw of participants at 36 and 48 months after Vaccination 3 was removed.",2.0,,,f,,,,t,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,INDUSTRY,,,,,,,2020,1.0
NCT03303235,,2017-09-26,,,2020-07-30,2017-10-02,2017-10-05,ACTUAL,,,,,,,2020-07-30,2020-08-03,ACTUAL,2020-07,ESTIMATED,2020-07-31,2020-07,2020-07-31,2020-12,ESTIMATED,2020-12-31,2020-10,ESTIMATED,2020-10-31,,INTERVENTIONAL,,,Intravenous Versus Intramuscular Administration of Methylergonovine for Uterine Contraction in Cesarean Sections,How's the Tone? Intravenous Versus Intramuscular Administration of Methylergonovine for Uterine Contraction in Cesarean Sections,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Johns Hopkins University,,2.0,,Collaborators left the institution.,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2020,0.0
NCT04123444,,2019-10-09,,,2024-05-06,2019-10-09,2019-10-11,ACTUAL,,,,,,,2024-05-06,2024-05-07,ACTUAL,2019-10-30,ACTUAL,2019-10-30,2024-05,2024-05-31,2022-06-28,ACTUAL,2022-06-28,2022-06-28,ACTUAL,2022-06-28,,INTERVENTIONAL,COMBAT-SHINE,,Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in Patients With Septic Shock Suffering From Organ Failure,"Efficacy and Safety of 72-hour Infusion of Prostacyclin (1 Nanogram(ng)/Kilo(kg)/Minute(Min)) in Patients With Septic Shock Induced Endotheliopathy - a Multicentre Randomized, Placebo-controlled, Blinded, Investigator-initiated Trial",COMPLETED,,PHASE2/PHASE3,279.0,ACTUAL,"Rigshospitalet, Denmark",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,OTHER,,,,,,,2022,0.0
NCT03888066,,2019-03-12,2022-08-25,,2023-02-22,2019-03-21,2019-03-25,ACTUAL,2023-02-22,2023-02-24,ACTUAL,,,,2023-02-22,2023-02-24,ACTUAL,2019-04-24,ACTUAL,2019-04-24,2023-02,2023-02-28,2021-09-02,ACTUAL,2021-09-02,2021-09-02,ACTUAL,2021-09-02,,INTERVENTIONAL,DIAMOND,,Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND),"A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin Angiotensin Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)",COMPLETED,,PHASE3,1195.0,ACTUAL,Vifor Pharma,,2.0,,,f,,,,t,t,f,,,,,,"Data can be requested 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later.~Data will be indefinitely available for requesting",A research proposal must be approved by an independent review panel and the study sponsor and researchers must sign a data sharing agreement.,,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2021,1.0
NCT06610279,,2024-09-21,,,2024-09-21,2024-09-21,2024-09-24,ACTUAL,,,,,,,2024-09-21,2024-09-24,ACTUAL,2022-01-07,ACTUAL,2022-01-07,2024-09,2024-09-30,2023-09-21,ACTUAL,2023-09-21,2023-09-21,ACTUAL,2023-09-21,,INTERVENTIONAL,,,A Study of TAK-951 in Healthy Adults,"A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, 3-Part Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-951 in Healthy Subjects",TERMINATED,,PHASE1,48.0,ACTUAL,Takeda,,9.0,,The study was terminated based on the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data of this study.,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,INDUSTRY,,,,,,,2023,0.0
NCT04563936,,2020-09-21,,,2021-08-20,2020-09-21,2020-09-25,ACTUAL,,,,,,,2021-08-20,2021-08-26,ACTUAL,2020-01-06,ACTUAL,2020-01-06,2021-08,2021-08-31,2021-03-09,ACTUAL,2021-03-09,2021-03-09,ACTUAL,2021-03-09,,INTERVENTIONAL,,,Efficacy and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX®,"A Multicenter, Randomized, Open-Label Phase Ⅲ Trial to Compare Efficacy and Safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in Patients With Prostate Cancer",COMPLETED,,PHASE3,290.0,ACTUAL,Luye Pharma Group Ltd.,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2021,1.0
NCT04307940,,2020-03-05,2021-09-09,,2022-07-12,2020-03-11,2020-03-13,ACTUAL,2021-09-09,2021-10-07,ACTUAL,,,,2022-07-12,2022-07-14,ACTUAL,2020-03-12,ACTUAL,2020-03-12,2022-07,2022-07-31,2020-10-05,ACTUAL,2020-10-05,2020-10-02,ACTUAL,2020-10-02,,INTERVENTIONAL,,Safety Population: included all subjects who were randomized and received at least one dose of study drug,Study to Collect Information on How Well the Study Drug Naproxen Sodium Tablets Works Compared to Hydrocodone/Acetaminophen Tablets in Order to Relieve Pain in Participants Experiencing Moderate to Severe Pain After Having Their Wisdom Teeth Removed,"A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Hydrocodone/Acetaminophen Tablets in Postsurgical Dental Pain",COMPLETED,,PHASE4,221.0,ACTUAL,Bayer,,3.0,,,f,,,,f,t,f,,,f,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,INDUSTRY,,,,,,,2020,1.0
NCT03003195,,2016-12-19,,,2024-08-29,2016-12-21,2016-12-26,ESTIMATED,,,,,,,2024-08-29,2024-09-03,ACTUAL,2021-03-01,ACTUAL,2021-03-01,2021-03,2021-03-31,2021-03-01,ACTUAL,2021-03-01,2021-03-01,ACTUAL,2021-03-01,,INTERVENTIONAL,,,The P10s-PADRE Basket Trial: Vaccination of Metastatic Cancer Patients,A Combined Phase I/II Study of a Carbohydrate Mimotope-Based Vaccine with MONTANIDE™ ISA 51 VG STERILE for Metastatic Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Arkansas,,1.0,,Lack of Funding,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2021,0.0
NCT04173325,,2019-11-14,,,2022-06-10,2019-11-20,2019-11-21,ACTUAL,,,,,,,2022-06-10,2022-06-14,ACTUAL,2020-01-06,ACTUAL,2020-01-06,2022-06,2022-06-30,2022-05-26,ACTUAL,2022-05-26,2022-05-26,ACTUAL,2022-05-26,,INTERVENTIONAL,,,Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer,Phase I Feasibility and Safety Study of Nivolumab in Combination With Irinotecan in Relapsed or Refractory Small Cell Lung Cancer (SCLC) Followed by Maintenance Nivolumab,TERMINATED,,PHASE1,10.0,ACTUAL,Augusta University,,1.0,,Closed by the IRB 5/26/22 due to non-compliance,f,,,,t,t,f,,,,,,,,,,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2022,0.0
NCT02623699,,2015-11-24,2023-05-17,2022-07-15,2023-07-07,2015-12-03,2015-12-08,ESTIMATED,2023-07-07,2023-07-28,ACTUAL,2022-07-15,2022-07-19,ACTUAL,2023-07-07,2023-07-28,ACTUAL,2016-01-20,ACTUAL,2016-01-20,2023-07,2023-07-31,2021-07-16,ACTUAL,2021-07-16,2021-07-16,ACTUAL,2021-07-16,,INTERVENTIONAL,VALOR (Part C),"Intention-to-Treat (ITT) populations for parts A, B, and C included all randomized participants who received at least 1 dose or a part of 1 dose of study treatment (BIIB067 or placebo) in Parts A, B, and C respectively. The demographics data reported for Part B arm groups included only the unique participants who were enrolled directly into Part B of the study.","An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 (Tofersen) in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)","A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB067 Administered to Adult Subjects With Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation",COMPLETED,,PHASE3,176.0,ACTUAL,Biogen,,12.0,,,f,,,,t,t,f,,,f,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,INDUSTRY,,,,,,,2021,1.0
NCT04187144,,2019-12-03,2023-05-29,,2023-07-15,2019-12-03,2019-12-05,ACTUAL,2023-07-15,2023-07-18,ACTUAL,,,,2023-07-15,2023-07-18,ACTUAL,2020-04-23,ACTUAL,2020-04-23,2023-07,2023-07-31,2022-12-01,ACTUAL,2022-12-01,2022-12-01,ACTUAL,2022-12-01,,INTERVENTIONAL,,Participants randomly assigned to the study treatment were included in the ITT population.,Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI),"A Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of Gepotidacin to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)",COMPLETED,,PHASE3,1606.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,INDUSTRY,,,,,,,2022,1.0
NCT05081986,,2021-09-27,,,2023-09-06,2021-10-05,2021-10-18,ACTUAL,,,,,,,2023-09-06,2023-09-07,ACTUAL,2021-08-18,ACTUAL,2021-08-18,2023-09,2023-09-30,2022-02-23,ACTUAL,2022-02-23,2021-10-06,ACTUAL,2021-10-06,,INTERVENTIONAL,,,Repeated iTBS Cycloserine Motor Plasticity,"Motor Plasticity Enhancement of Spaced iTBS Trains: a Randomized, Placebo-controlled, Crossover Trial of D-cycloserine.",COMPLETED,,PHASE2,20.0,ACTUAL,University of Calgary,,2.0,,,f,,,,f,t,t,,,t,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2022,1.0
NCT05087992,,2021-10-11,,,2024-01-17,2021-10-11,2021-10-21,ACTUAL,,,,,,,2024-01-17,2024-01-18,ACTUAL,2021-11-24,ACTUAL,2021-11-24,2024-01,2024-01-31,2023-11-14,ACTUAL,2023-11-14,2023-10-23,ACTUAL,2023-10-23,,INTERVENTIONAL,,,A Study to Find the Best Dose of BI 905711 in Combination With Chemotherapy and to Test Whether This Dose Helps People With Advanced Gastrointestinal Cancers,"A Phase Ia/Ib, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Combination With Chemotherapy Followed by Expansion Cohorts in Patients With Advanced Gastrointestinal Cancers",COMPLETED,,PHASE1,13.0,ACTUAL,Boehringer Ingelheim,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,INDUSTRY,,,,,,,2023,0.0
NCT03199053,,2017-06-22,2024-01-31,,2024-05-28,2017-06-23,2017-06-26,ACTUAL,2024-03-20,2024-04-17,ACTUAL,,,,2024-05-28,2024-06-21,ACTUAL,2017-10-11,ACTUAL,2017-10-11,2024-05,2024-05-31,2024-01-03,ACTUAL,2024-01-03,2023-02-01,ACTUAL,2023-02-01,,INTERVENTIONAL,,Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period.,Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old,"A 26 Week, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 3 Trial With a 26 Week Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 5 and 10 mg, and Saxagliptin 2.5 and 5 mg in Pediatric Patients With Type 2 Diabetes Mellitus Who Are Between 10 and Below 18 Years of Age",COMPLETED,,PHASE3,256.0,ACTUAL,AstraZeneca,"Due to legal dispute, the source documents could not be accessed for 11 participants at 1 site. All data from this site were excluded as documented in the statistical analysis plan.",5.0,,,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,INDUSTRY,,,,,,,2024,1.0
NCT01851083,,2013-05-05,,2020-11-16,2020-11-19,2013-05-09,2013-05-10,ESTIMATED,,,,2020-11-19,2020-11-20,ACTUAL,2020-11-19,2020-11-20,ACTUAL,2013-08,,2013-08-31,2020-11,2020-11-30,2020-10-12,ACTUAL,2020-10-12,2020-09-16,ACTUAL,2020-09-16,,INTERVENTIONAL,,,Pediatric Autologous Bone Marrow Mononuclear Cells for Severe Traumatic Brain Injury,A Phase 2 Multicenter Trial of Pediatric Autologous Bone Marrow Mononuclear Cells (BMMNCs) for Severe Traumatic Brain Injury (TBI),COMPLETED,,PHASE2,47.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2020,1.0
NCT04747470,,2021-02-05,2024-03-14,,2024-08-28,2021-02-05,2021-02-10,ACTUAL,2024-08-28,2024-09-03,ACTUAL,,,,2024-08-28,2024-09-03,ACTUAL,2021-03-25,ACTUAL,2021-03-25,2024-08,2024-08-31,2022-11-07,ACTUAL,2022-11-07,2022-11-07,ACTUAL,2022-11-07,,INTERVENTIONAL,,The Safety Analysis Set included all participants who received at least 1 dose of study drug.,Study to Assess the Effects of GS-3583 in Participants With Advanced Solid Tumors,"A Phase 1b Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583, a FLT3 Agonist Fc Fusion Protein, in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,13.0,ACTUAL,Gilead Sciences,,11.0,,"Sponsor decision to prematurely discontinue the study, following an internal safety assessment of the molecule, GS-3583.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2022,0.0
NCT02774291,,2016-05-13,2021-08-06,,2023-07-17,2016-05-16,2016-05-17,ESTIMATED,2023-07-17,2023-08-04,ACTUAL,,,,2023-07-17,2023-08-04,ACTUAL,2017-04-20,ACTUAL,2017-04-20,2023-07,2023-07-31,2020-08-04,ACTUAL,2020-08-04,2020-07-01,ACTUAL,2020-07-01,,INTERVENTIONAL,,,Anti-NY ESO-1 mTCR Peripheral Blood Lymphocytes,Pilot Study of Adoptive Cell Transfer for the Treatment of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-1 Murine TCR-Gene Engineered Lymphocytes,TERMINATED,,EARLY_PHASE1,3.0,ACTUAL,Albert Einstein College of Medicine,,1.0,,Due to lack of accrual the study was formally terminated on 01-JUL-2020. Primary Completion and Study Completion Dates have been revised based accordingly based on respective definitions,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,OTHER,,,,,,,2020,0.0
NCT04516941,,2020-08-05,,,2022-09-02,2020-08-17,2020-08-18,ACTUAL,,,,,,,2022-09-02,2022-09-08,ACTUAL,2021-01-21,ACTUAL,2021-01-21,2021-08,2021-08-31,2022-08-31,ACTUAL,2022-08-31,2022-08-31,ACTUAL,2022-08-31,,INTERVENTIONAL,CONVINCE,,CorONa Virus edoxabaN ColchicinE (CONVINCE) COVID-19,Efficacy and Safety of Edoxaban and or Colchicine for Patients With SARS-CoV-2 Infection Managed in the Out of Hospital Setting,TERMINATED,,PHASE3,60.0,ACTUAL,"Insel Gruppe AG, University Hospital Bern",,4.0,,Insufficient rate of patient accrual and newly available scientific evidence,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,OTHER,,,,,,,2022,0.0
NCT02454933,,2015-05-14,2018-07-16,,2024-09-06,2015-05-22,2015-05-27,ESTIMATED,2018-07-16,2018-08-10,ACTUAL,,,,2024-09-06,2024-09-19,ACTUAL,2015-07-15,ACTUAL,2015-07-15,2024-09,2024-09-30,2023-06-21,ACTUAL,2023-06-21,2017-08-21,ACTUAL,2017-08-21,,INTERVENTIONAL,CAURAL,The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.,Study of AZD9291 Plus MEDI4736 Versus AZD9291 Monotherapy in NSCLC After Previous EGFR TKI Therapy in T790M Mutation Positive Tumours,"A Phase III, Multi-Centre, Open Label, Randomized Study to Assess the Efficacy and Safety of AZD9291 in Combination With MEDI4736 Versus AZD9291 Monotherapy in Patients With Locally Advanced or Metastatic Epidermal Growth Factor Receptor T790M Mutation-positive Non-Small Cell Lung Cancer Who Have Received Prior Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy (CAURAL)",COMPLETED,,PHASE3,29.0,ACTUAL,AstraZeneca,Subject enrolment was terminated early on 29 September 2015 after higher than anticipated incidence of interstitial lung disease-like events in subjects receiving osimertinib + durvalumab in a separate Phase Ib open-label study D5160C00006 (TATTON).,2.0,,,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2023,0.0
NCT03170115,,2017-04-17,,,2020-12-14,2017-05-26,2017-05-30,ACTUAL,,,,,,,2020-12-14,2020-12-17,ACTUAL,2017-11-30,ACTUAL,2017-11-30,2020-12,2020-12-31,2020-01-17,ACTUAL,2020-01-17,2020-01-17,ACTUAL,2020-01-17,,INTERVENTIONAL,ICAR,,Induction Chemotherapy Plus Chemoradiotherapy With or Without Aspirin in High Risk Rectal Cancer,Phase II Randomized Study of Induction Chemotherapy Followed by Chemoradiotherapy With or Without Aspirin in High Risk Locally Advanced Rectal Cancer,TERMINATED,,PHASE2,25.0,ACTUAL,"Instituto Nacional de Cancer, Brazil",,2.0,,Aspirin added to chemoradiotherapy was safe but did not improve response to total neoadjuvant treatment. The study was closed due absence of benefit.,f,,,,f,f,f,,,t,,,,,,NO,,2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,OTHER_GOV,,,,,,,2020,0.0
NCT03518567,,2018-04-09,2024-01-08,,2024-02-07,2018-05-03,2018-05-08,ACTUAL,2024-02-07,2024-02-12,ACTUAL,,,,2024-02-07,2024-02-12,ACTUAL,2018-10-15,ACTUAL,2018-10-15,2024-02,2024-02-29,2021-05-24,ACTUAL,2021-05-24,2021-05-24,ACTUAL,2021-05-24,,INTERVENTIONAL,,,Behavioral Economic Analysis of Demand for Marijuana,Behavioral Economic Analysis of Demand for Marijuana,COMPLETED,,PHASE2,133.0,ACTUAL,Brown University,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,OTHER,,,,,,,2021,1.0
NCT04981717,,2021-07-19,2023-12-20,,2024-05-15,2021-07-28,2021-07-29,ACTUAL,2024-05-15,2024-06-11,ACTUAL,,,,2024-05-15,2024-06-11,ACTUAL,2021-07-30,ACTUAL,2021-07-30,2024-05,2024-05-31,2023-04-24,ACTUAL,2023-04-24,2023-01-04,ACTUAL,2023-01-04,,INTERVENTIONAL,,,A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat,"A Randomized, Double-Blind, Placebo-Controlled Study in Cat-Allergic Patients With Allergic Rhinitis Who Live With a Cat to Assess the Efficacy and Safety of Anti-Fel d 1 Antibodies During Natural Cat Exposure in the Home",TERMINATED,,PHASE3,446.0,ACTUAL,Regeneron Pharmaceuticals,"The study met prespecified interim futility criteria for CSMS and TNSS, therefore, an efficacy analysis was not performed for the primary and secondary endpoints as specified in the protocol",2.0,,Lack of efficacy,f,,,,t,t,f,,,,,,"When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.",Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf,https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2023,0.0
NCT04727151,,2021-01-20,,,2024-06-04,2021-01-26,2021-01-27,ACTUAL,,,,,,,2024-06-04,2024-06-06,ACTUAL,2021-04-19,ACTUAL,2021-04-19,2024-06,2024-06-30,2024-03-25,ACTUAL,2024-03-25,2023-12-17,ACTUAL,2023-12-17,,INTERVENTIONAL,TACTIC-2,,TAC T-cells for the Treatment of HER2-positive Solid Tumors,"A Phase 1/2 Trial Investigating the Safety and Efficacy of Autologous TAC T Cell Monotherapy, and TAC T Cells in Combination With Pembrolizumab, in Relapsed HER2-Positive Solid Tumors",TERMINATED,,PHASE1/PHASE2,30.0,ACTUAL,"Triumvira Immunologics, Inc.",,2.0,,Study terminated by Sponsor for commercial reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,INDUSTRY,,,,,,,2024,0.0
NCT04208386,,2019-12-20,,,2020-09-29,2019-12-20,2019-12-23,ACTUAL,,,,,,,2020-09-29,2020-09-30,ACTUAL,2020-01-08,ACTUAL,2020-01-08,2020-09,2020-09-30,2020-07-20,ACTUAL,2020-07-20,2020-07-20,ACTUAL,2020-07-20,,INTERVENTIONAL,,,A Study to Evaluate the Effect of Hepatic Impairment on JNJ-73763989,"A Phase 1, Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of JNJ-73763989",COMPLETED,,PHASE1,16.0,ACTUAL,Janssen Sciences Ireland UC,,4.0,,,f,,,,f,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,INDUSTRY,,,,,,,2020,1.0
NCT02848001,,2016-06-22,,,2024-05-13,2016-07-25,2016-07-28,ESTIMATED,,,,,,,2024-05-13,2024-05-14,ACTUAL,2016-11-14,ACTUAL,2016-11-14,2024-05,2024-05-31,2024-04-11,ACTUAL,2024-04-11,2023-04-11,ACTUAL,2023-04-11,,INTERVENTIONAL,,,A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes,"A Phase 1, Open-label, Dose Finding Study of CC-90009, a Novel Cereblon E3 Ligase Modulating Drug, in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes",TERMINATED,,PHASE1,101.0,ACTUAL,Celgene,,2.0,,Trial terminated because of lack of efficacy in the short term acute phase.,f,,,,f,,,,,,,,,,,,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2024,0.0
NCT05375253,,2022-05-10,,,2024-08-29,2022-05-10,2022-05-16,ACTUAL,,,,,,,2024-08-29,2024-09-03,ACTUAL,2023-04-12,ACTUAL,2023-04-12,2024-08,2024-08-31,2023-04-12,ACTUAL,2023-04-12,2023-04-12,ACTUAL,2023-04-12,,INTERVENTIONAL,,,Donor Enriched Activated NK Cell Infusion Post Haploidentical Stem Cell Transplant for Refractory Myeloid Malignancies,A Phase I Trial of Donor Enriched Activated NK (DEA-NK) Cell Infusion Post Haploidentical Stem Cell Transplant for Refractory Myeloid Malignancies,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Nebraska,,1.0,,PI has left institution and is taking the study with him.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,OTHER,,,,,,,2023,0.0
NCT02883062,,2016-08-29,2024-04-11,,2024-07-02,2016-08-29,2016-08-30,ESTIMATED,2024-05-22,2024-06-18,ACTUAL,,,,2024-07-02,2024-07-25,ACTUAL,2017-08-02,ACTUAL,2017-08-02,2024-05,2024-05-31,2020-12-20,ACTUAL,2020-12-20,2019-12-18,ACTUAL,2019-12-18,,INTERVENTIONAL,,,"Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer","Randomized Phase 2 Study of Neoadjuvant Chemotherapy, Carboplatin and Paclitaxel, With or Without Atezolizumab in Triple Negative Breast Cancer (TNBC)",COMPLETED,,PHASE2,67.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,NIH,,,,,,,2020,1.0
NCT02657005,,2016-01-12,,,2022-06-21,2016-01-13,2016-01-15,ESTIMATED,,,,,,,2022-06-21,2022-06-22,ACTUAL,2016-08,ACTUAL,2016-08-31,2022-06,2022-06-30,2022-06,ACTUAL,2022-06-30,2022-05,ACTUAL,2022-05-31,,INTERVENTIONAL,,,TK216 in Patients With Relapsed or Refractory Ewing Sarcoma,"A Phase 1 / 2, Dose Escalation Study of Intravenous TK216 in Patients With Relapsed or Refractory Ewing Sarcoma",TERMINATED,,PHASE1/PHASE2,85.0,ACTUAL,"Oncternal Therapeutics, Inc",,1.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 20:22:16.565854,2024-10-16 20:22:16.565854,INDUSTRY,,,,,,,2022,0.0
NCT04345861,,2020-04-05,,,2021-12-14,2020-04-09,2020-04-15,ACTUAL,,,,,,,2021-12-14,2021-12-15,ACTUAL,2020-04-11,ACTUAL,2020-04-11,2021-12,2021-12-31,2021-04-09,ACTUAL,2021-04-09,2021-02-09,ACTUAL,2021-02-09,,INTERVENTIONAL,COVIDOC,,Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for COVID-19 Pneumonia (COVIDOC Trial),Randomized Trial Assessing Efficacy and Safety of Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for Hospitalized Adults With COVID-19 Pneumonia,TERMINATED,,PHASE2/PHASE3,7.0,ACTUAL,"University Hospital, Montpellier",,2.0,,halted prematurely.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,OTHER,,,,,,,2021,0.0
NCT03616574,,2018-06-26,,,2022-09-20,2018-08-03,2018-08-06,ACTUAL,,,,,,,2022-09-20,2022-09-21,ACTUAL,2019-04-09,ACTUAL,2019-04-09,2022-03,2022-03-31,2022-03-01,ACTUAL,2022-03-01,2022-02-08,ACTUAL,2022-02-08,,INTERVENTIONAL,,,First-in-human Study of CA102N Monotherapy and CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors,"Phase 1,Two-part (Dose Escalation, Dose Expansion), Multicenter,Non-randomized,Open-label, Multiple Dose, First-in-human Study of CA102N Monotherapy and of CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors",COMPLETED,,PHASE1,37.0,ACTUAL,"Holy Stone Healthcare Co., Ltd",,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 21:24:29.407204,2024-10-16 21:24:29.407204,INDUSTRY,,,,,,,2022,1.0
NCT04430959,,2020-05-11,,,2022-04-19,2020-06-10,2020-06-16,ACTUAL,,,,,,,2022-04-19,2022-04-27,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2022-04,2022-04-30,2022-09-01,ESTIMATED,2022-09-01,2022-07-01,ESTIMATED,2022-07-01,,INTERVENTIONAL,,,Candesartan as an Adjunctive Treatment for Bipolar Depression,"A Pilot, Proof of Concept, Placebo-controlled Trial of Candesartan as an Adjunctive Treatment for Bipolar Depression",WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,"The reason the study was withdrawn was due to lack of funds. In addition, the PI is moving to a different institution and it would not be feasible to proceed with the study under these circumstances.",f,,,,f,t,f,,,f,,,,,,,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,OTHER,,,,,,,2022,0.0
NCT02031419,,2014-01-07,,,2024-01-16,2014-01-07,2014-01-09,ESTIMATED,,,,,,,2024-01-16,2024-01-18,ACTUAL,2013-12-18,ACTUAL,2013-12-18,2024-01,2024-01-31,2023-12-12,ACTUAL,2023-12-12,2023-12-12,ACTUAL,2023-12-12,,INTERVENTIONAL,,,"Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-cell Lymphoma and Follicular Lymphoma","A Phase 1B, Multi-Center, Open-Label Study of Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-Cell Lymphoma and Follicular Lymphoma",TERMINATED,,PHASE1,174.0,ACTUAL,Celgene,,4.0,,Replaced with another clinical trial.,f,,,,f,,,,,,,,,,,,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,INDUSTRY,,,,,,,2023,0.0
NCT04584684,,2020-10-09,2023-01-27,2022-09-26,2024-03-22,2020-10-09,2020-10-14,ACTUAL,2024-03-22,2024-03-25,ACTUAL,,2024-03-25,ACTUAL,2024-03-22,2024-03-25,ACTUAL,2020-12-18,ACTUAL,2020-12-18,2024-02,2024-02-29,2021-10-21,ACTUAL,2021-10-21,2021-10-21,ACTUAL,2021-10-21,,INTERVENTIONAL,MOR,,Mouth Rinses for Inactivation of COVID-19,Antiviral Efficacy and Acceptability of Therapeutic Antiseptic Mouth Rinses for Inactivation of COVID SARS-2 Virus,TERMINATED,,PHASE2,128.0,ACTUAL,"University of North Carolina, Chapel Hill",,6.0,,"The team decided to terminate the trial in order to start a new trial, unrelated to safety reasons",f,,,,f,t,f,,,f,,,following publication up to 1 year,"Deidentified individual data that supports the results will be shared beginning following publication up to 1 year provided the investigator who proposes to use the data has approval from an IRB, IEC, or REB as applicable, and an executed data use/sharing agreement with UNC.",,YES,"Deidentified individual data that supports the results will be shared beginning following publication up to 1 year provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.",2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,OTHER,,,,,,,2021,0.0
NCT04312789,,2020-03-16,,,2021-11-26,2020-03-16,2020-03-18,ACTUAL,,,,,,,2021-11-26,2021-12-09,ACTUAL,2022-12,ESTIMATED,2022-12-31,2021-11,2021-11-30,2022-12-31,ESTIMATED,2022-12-31,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Avatrombopag for the Treatment of Thrombocytopenia After Donor Hematopoietic Stem Cell Transplant,A Phase II Trial of Avatrombopag for the Treatment of Thrombocytopenia After Allogeneic Hematopoietic Stem Cell Transplant,WITHDRAWN,,PHASE2,0.0,ACTUAL,Ohio State University Comprehensive Cancer Center,,1.0,,Drug availability,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,OTHER,,,,,,,2022,0.0
NCT02370238,,2015-02-11,2021-04-06,,2022-08-23,2015-02-23,2015-02-24,ESTIMATED,2021-05-07,2021-06-02,ACTUAL,,,,2022-08-23,2022-09-16,ACTUAL,2015-07-29,ACTUAL,2015-07-29,2022-08,2022-08-31,2020-03-23,ACTUAL,2020-03-23,2019-02-20,ACTUAL,2019-02-20,,INTERVENTIONAL,FRIDA,The Safety Population consisted of 121 patients who took at least one dose of study treatment,A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer,"A Randomized, Double-blind, Placebo-controlled Phase 2 Study of Paclitaxel in Combination With Reparixin Compared to Paclitaxel Alone as Front-line Therapy for Metastatic Triple- Negative Breast Cancer (FRIDA)",COMPLETED,,PHASE2,194.0,ACTUAL,Dompé Farmaceutici S.p.A,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,INDUSTRY,,,,,,,2020,1.0
NCT03549650,,2018-04-23,,,2022-02-16,2018-05-25,2018-06-08,ACTUAL,,,,,,,2022-02-16,2022-03-04,ACTUAL,2019-05-03,ACTUAL,2019-05-03,2022-02,2022-02-28,2022-02-15,ACTUAL,2022-02-15,2022-02-15,ACTUAL,2022-02-15,,INTERVENTIONAL,,,Prevention and Management of Intravesical BCG-related Lower Urinary Tract Symptoms,Prevention and Management of Intravesical BCG-related Lower Urinary Tract Symptoms With Prophylactic Pentosan Polysulphate in Patients With Non-Muscle-Invasive Bladder Cancer: A Randomized Controlled Trial,TERMINATED,,PHASE2,3.0,ACTUAL,Sir Mortimer B. Davis - Jewish General Hospital,,2.0,,"Given the updated precautions on Elmiron as well as the risk benefit profile, we have decided to terminate the study.",f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,OTHER,,,,,,,2022,0.0
NCT04099836,,2019-09-20,2023-10-10,,2023-12-12,2019-09-20,2019-09-23,ACTUAL,2023-12-12,2023-12-26,ACTUAL,,,,2023-12-12,2023-12-26,ACTUAL,2020-07-09,ACTUAL,2020-07-09,2023-12,2023-12-31,2023-06-15,ACTUAL,2023-06-15,2022-11-13,ACTUAL,2022-11-13,,INTERVENTIONAL,,,Atezolizumab and Bevacizumab in EGFR Mutant NSCLC in Patients With Progressive Disease After Receiving Osimertinib,Single Arm Phase 2 Trial of Atezolizumab and Bevacizumab in Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer in Patients With Progressive Disease After Receiving Osimertinib (TOP 1901),TERMINATED,,PHASE2,7.0,ACTUAL,Duke University,,1.0,,low accrual,f,,,,t,t,f,,,,,,,,,NO,There is no plan to share participant level data.,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,OTHER,,,,,,,2023,0.0
NCT03552380,,2018-05-29,2022-08-29,,2024-08-26,2018-05-29,2018-06-11,ACTUAL,2024-08-26,2024-09-03,ACTUAL,,,,2024-08-26,2024-09-03,ACTUAL,2018-07-31,ACTUAL,2018-07-31,2024-08,2024-08-31,2024-02-15,ACTUAL,2024-02-15,2022-06-07,ACTUAL,2022-06-07,,INTERVENTIONAL,,,Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell Carcinoma,"A Phase II Study to Evaluate the Safety, Pharmacodynamics, and Efficacy of Entinostat in Combination With Nivolumab Plus Ipilimumab in Patients With Renal Cell Carcinoma Previously Treated With Nivolumab Plus Ipilimumab",TERMINATED,,PHASE2,12.0,ACTUAL,Hoosier Cancer Research Network,,1.0,,Funder halted development of compound in this disease,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,OTHER,,,,,,,2024,0.0
NCT03813199,,2019-01-15,2022-02-03,,2023-02-10,2019-01-18,2019-01-23,ACTUAL,2022-02-03,2022-04-07,ACTUAL,,,,2023-02-10,2023-02-15,ACTUAL,2019-07-04,ACTUAL,2019-07-04,2022-05,2022-05-31,2021-04-27,ACTUAL,2021-04-27,2021-04-27,ACTUAL,2021-04-27,,INTERVENTIONAL,,,Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis,"Phase IIa Randomized, Double Blind, Placebo Controlled, Multiple Dose Study on ABX464 in Combination With Methotrexate (MTX), in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have Inadequate Response to MTX or/and to Anti-Tnfα, or Intolerance to Anti-Tnfα",COMPLETED,,PHASE2,60.0,ACTUAL,Abivax S.A.,,3.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,INDUSTRY,,,,,,,2021,1.0
NCT04736745,,2021-01-12,,,2023-07-12,2021-02-01,2021-02-03,ACTUAL,,,,,,,2023-07-12,2023-07-14,ACTUAL,2021-02-10,ACTUAL,2021-02-10,2023-07,2023-07-31,2022-10-28,ACTUAL,2022-10-28,2022-10-28,ACTUAL,2022-10-28,,INTERVENTIONAL,LONG-SET,,Study to Evaluate the Safety and Efficacy of IPN59011 in Improving the Appearance of Moderate to Severe Upper Facial Lines.,"A Phase Ib/II, Multicentre, Double-blind, Randomised, Placebo-controlled Dose Escalation and Dose Finding Study to Evaluate the Safety and Efficacy of IPN59011 in Improving the Appearance of Moderate to Severe Upper Facial Lines",TERMINATED,,PHASE1,56.0,ACTUAL,Ipsen,,4.0,,Sponsor terminated the study due to strategic considerations,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,INDUSTRY,,,,,,,2022,0.0
NCT02874144,,2016-07-26,2021-04-08,,2022-05-04,2016-08-16,2016-08-22,ESTIMATED,2022-05-04,2022-05-25,ACTUAL,,,,2022-05-04,2022-05-25,ACTUAL,2016-06-20,ACTUAL,2016-06-20,2022-05,2022-05-31,2020-08-10,ACTUAL,2020-08-10,2020-01-07,ACTUAL,2020-01-07,,INTERVENTIONAL,E1416,,Anti-Inflammatory Agent in Sinusitis,"A Phase 2A, Single-Center, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy of an Anti-Inflammatory Agent in Patients With Sinusitis",COMPLETED,,PHASE2,43.0,ACTUAL,Northwestern University,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,OTHER,,,,,,,2020,1.0
NCT03190967,,2017-06-16,2023-08-17,,2023-09-15,2017-06-16,2017-06-19,ACTUAL,2023-09-15,2023-10-11,ACTUAL,,,,2023-09-15,2023-10-11,ACTUAL,2018-04-18,ACTUAL,2018-04-18,2023-09,2023-09-30,2023-06-13,ACTUAL,2023-06-13,2021-06-28,ACTUAL,2021-06-28,,INTERVENTIONAL,,,T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery,Phase I/II Study of T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery,TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,The phase II portion was never started as we could no longer get the drug from the manufacturer.,f,,,,t,t,f,,,f,,,Clinical data are available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.,,YES,"All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).",2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,NIH,,,,,,,2023,0.0
NCT02954406,,2016-11-02,2021-07-26,,2021-12-07,2016-11-02,2016-11-03,ESTIMATED,2021-12-07,2022-02-18,ACTUAL,,,,2021-12-07,2022-02-18,ACTUAL,2017-03-05,ACTUAL,2017-03-05,2021-12,2021-12-31,2020-07-27,ACTUAL,2020-07-27,2020-07-27,ACTUAL,2020-07-27,,INTERVENTIONAL,,Safety Analysis Set included participants who have received at least 1 dose of study drug.,"A Study of TAK-659 in Combination With Bendamustine (+/-Rituximab), Gemcitabine, Lenalidomide, or Ibrutinib for the Treatment of Participants With Advanced Non-Hodgkin Lymphoma","A Phase 1b, Dose Escalation Study to Determine the Recommended Phase 2 Dose of TAK-659 in Combination With Bendamustine (±Rituximab), Gemcitabine, Lenalidomide, or Ibrutinib for the Treatment of Patients With Advanced Non-Hodgkin Lymphoma After At Least 1 Prior Line of Therapy",TERMINATED,,PHASE1,43.0,ACTUAL,Takeda,,11.0,,"Business decision, insufficient enrollment, no safety or efficacy concerns.",f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,INDUSTRY,,,,,,,2020,0.0
NCT05119894,,2021-11-12,,,2022-04-20,2021-11-12,2021-11-15,ACTUAL,,,,,,,2022-04-20,2022-04-28,ACTUAL,2021-11-22,ACTUAL,2021-11-22,2022-04,2022-04-30,2021-12-06,ACTUAL,2021-12-06,2021-12-06,ACTUAL,2021-12-06,,INTERVENTIONAL,,,A Clinical Pharmacology Trial of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia,"A Multicenter, Open-label, Clinical Pharmacology Trial to Determine the Pharmacokinetics, Tolerability, and Safety of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Otsuka Pharmaceutical Co., Ltd.",,4.0,,Sponsor decision:Change the Development plan,f,,,,f,f,f,,,,,,"Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.",Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.,,YES,Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.,2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,INDUSTRY,,,,,,,2021,0.0
NCT02510976,,2015-07-27,,,2024-07-09,2015-07-28,2015-07-29,ESTIMATED,,,,,,,2024-07-09,2024-07-10,ACTUAL,2011-11,,2011-11-30,2024-07,2024-07-31,2021-01-08,ACTUAL,2021-01-08,2021-01-08,ACTUAL,2021-01-08,,INTERVENTIONAL,,,Prucalopride Versus Placebo in Gastroparesis,Prucalopride Versus Placebo in Functional Dyspepsia With Delayed Gastric Emptying,TERMINATED,,PHASE4,60.0,ACTUAL,Universitaire Ziekenhuizen KU Leuven,,2.0,,Prematurely stopped due to slow recruitment and expiry of study drug.,f,,,,f,,,,,,,,,,,,,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,OTHER,,,,,,,2021,0.0
NCT05243524,,2022-02-07,,,2023-09-11,2022-02-07,2022-02-17,ACTUAL,,,,,,,2023-09-11,2023-09-13,ACTUAL,2022-08-05,ACTUAL,2022-08-05,2023-09,2023-09-30,2023-08-31,ACTUAL,2023-08-31,2023-07-24,ACTUAL,2023-07-24,,INTERVENTIONAL,AVALON,,Maveropepimut-S (MVP-S) and Low-Dose CPA in Patients With Platinum-Resistant Ovarian Cancer,"Phase 2b Single Arm Study of Maveropepimut-S and Low-Dose Cyclophosphamide in Subjects With Platinum-Resistant, Epithelial Ovarian Cancer.",TERMINATED,,PHASE2,16.0,ACTUAL,"ImmunoVaccine Technologies, Inc. (IMV Inc.)",,1.0,,Closure of IMV operations,,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,INDUSTRY,,,,,,,2023,0.0
NCT02706405,,2016-02-24,2022-05-06,,2022-08-01,2016-03-07,2016-03-11,ESTIMATED,2022-08-01,2022-08-24,ACTUAL,,,,2022-08-01,2022-08-24,ACTUAL,2016-11-15,ACTUAL,2016-11-15,2022-08,2022-08-31,2021-05-28,ACTUAL,2021-05-28,2021-05-28,ACTUAL,2021-05-28,,INTERVENTIONAL,,,JCAR014 and Durvalumab in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma,"A Phase 1b Study of JCAR014, Autologous T Cells Engineered to Express a CD19-Specific Chimeric Antigen Receptor, in Combination With Durvalumab (MEDI4736) for Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma",TERMINATED,,PHASE1,30.0,ACTUAL,Fred Hutchinson Cancer Center,,8.0,,Terminated due to slow accrual.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,OTHER,,,,,,,2021,0.0
NCT03993379,,2019-05-14,2021-09-02,,2021-11-02,2019-06-19,2019-06-20,ACTUAL,2021-11-02,2021-12-01,ACTUAL,,,,2021-11-02,2021-12-01,ACTUAL,2019-11-20,ACTUAL,2019-11-20,2021-11,2021-11-30,2020-05-21,ACTUAL,2020-05-21,2020-05-21,ACTUAL,2020-05-21,,INTERVENTIONAL,,"Due to the early study termination, a statistical analysis plan was not generated. The statistical analyses per the study protocol were not performed due to insufficient sample size and the efficacy and pharmacokinetic analyses were not performed.",PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors,"A Phase 2, Open-Label, Multi-cohort Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors",TERMINATED,,PHASE2,3.0,ACTUAL,CytomX Therapeutics,"Due to developmental strategic reasons and slow enrollment because of the COVID-19 pandemic, the study was terminated early. Three subjects were enrolled, all in Cohort A2. The last subject observation for this study was on 21 May 2020. Since the study terminated early, a statistical analysis plan was not generated.",4.0,,Sponsor's Decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,INDUSTRY,,,,,,,2020,0.0
NCT04552795,,2020-08-11,2024-05-03,,2024-08-07,2020-09-10,2020-09-17,ACTUAL,2024-08-07,2024-08-09,ACTUAL,,,,2024-08-07,2024-08-09,ACTUAL,2021-02-15,ACTUAL,2021-02-15,2024-07,2024-07-31,2023-11-04,ACTUAL,2023-11-04,2023-05-04,ACTUAL,2023-05-04,,INTERVENTIONAL,ART-AD,,Pilot Study to Investigate the Safety and Feasibility of AntiRetroviral Therapy for Alzheimer's Disease,Pilot Study to Investigate the Safety and Feasibility of AntiRetroviral Therapy for Alzheimer's Disease (ART-AD),COMPLETED,,PHASE1/PHASE2,12.0,ACTUAL,The University of Texas Health Science Center at San Antonio,,1.0,,,f,,,,t,t,f,,,t,,,"After study completion, upon publication of data and on ClinicalTrials.gov 1 year after primary completion date of study.",Data will be analyzed by the study investigators.,,YES,"Protocol, Published Data",2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,OTHER,,,,,,,2023,1.0
NCT05322616,,2022-03-14,,,2023-05-26,2022-04-03,2022-04-12,ACTUAL,,,,,,,2023-05-26,2023-05-31,ACTUAL,2022-10-21,ACTUAL,2022-10-21,2023-05,2023-05-31,2023-05-26,ACTUAL,2023-05-26,2023-05-26,ACTUAL,2023-05-26,,INTERVENTIONAL,,,Single-Ascending Dose Study of JK07 in Subjects With HFpEF,"A Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Assess the Safety and Tolerability of JK07 in Subjects With Heart Failure With Preserved Ejection Fraction (HFpEF)",WITHDRAWN,,PHASE1,0.0,ACTUAL,Salubris Biotherapeutics Inc,,2.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:37:07.501964,2024-10-15 13:37:07.501964,INDUSTRY,,,,,,,2023,0.0
NCT03298958,,2017-09-26,,,2019-06-07,2017-09-26,2017-10-02,ACTUAL,,,,,,,2019-06-07,2019-06-12,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2019-06,2019-06-30,2022-05-01,ESTIMATED,2022-05-01,2022-02-01,ESTIMATED,2022-02-01,,INTERVENTIONAL,,,Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive Bladder Cancer,Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive Bladder Cancer,WITHDRAWN,,PHASE3,0.0,ACTUAL,The University of Texas Health Science Center at San Antonio,,2.0,,"No funding was received, no subjects were enrolled",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:24:29.407204,2024-10-16 21:24:29.407204,OTHER,,,,,,,2022,0.0
NCT05510427,,2022-08-16,,,2023-08-10,2022-08-18,2022-08-22,ACTUAL,,,,,,,2023-08-10,2023-08-15,ACTUAL,2023-08-07,ACTUAL,2023-08-07,2023-08,2023-08-31,2023-08-07,ACTUAL,2023-08-07,2023-08-07,ACTUAL,2023-08-07,,INTERVENTIONAL,,,Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification,Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification,WITHDRAWN,,PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,Per PI's request,f,,,,t,t,f,,,,,,,,,,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,OTHER,,,,,,,2023,0.0
NCT05212818,,2022-01-20,,2024-01-04,2024-01-04,2022-01-25,2022-01-28,ACTUAL,,,,,2024-01-08,ACTUAL,2024-01-04,2024-01-08,ACTUAL,2022-05-10,ACTUAL,2022-05-10,2024-01,2024-01-31,2023-03-08,ACTUAL,2023-03-08,2023-02-03,ACTUAL,2023-02-03,,INTERVENTIONAL,,,Evaluate the Efficacy and Safety of TF0023 in Treatments for COVID-19 in Hospitalized Adults,"A Phase 2, Multicenter, Randomized, Double-blind (Within Dose), Placebo-controlled, Parallel-group, and Dose-range-finding to Evaluate the Efficacy and Safety in Treatments for COVID-19 in Hospitalized Adults",TERMINATED,,PHASE2,19.0,ACTUAL,Techfields Inc,,4.0,,Low patient accrual.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,INDUSTRY,,,,,,,2023,0.0
NCT02743546,,2016-04-15,,,2017-11-22,2016-04-15,2016-04-19,ESTIMATED,,,,,,,2017-11-22,2017-11-24,ACTUAL,2016-07-20,ESTIMATED,2016-07-20,2017-11,2017-11-30,2020-03-31,ESTIMATED,2020-03-31,2018-09-30,ESTIMATED,2018-09-30,,INTERVENTIONAL,,,"Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Duvortuxizumab (JNJ-64052781) Plus Ibrutinib in Lymphoma","A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of the Combination of Duvortuxizumab With Ibrutinib in Subjects With B-Cell Malignancies",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Janssen Research & Development, LLC",,5.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,INDUSTRY,,,,,,,2020,0.0
NCT05028114,,2021-08-19,,,2023-10-15,2021-08-24,2021-08-31,ACTUAL,,,,,,,2023-10-15,2023-10-17,ACTUAL,2021-08-31,ACTUAL,2021-08-31,2023-10,2023-10-31,2022-07-19,ACTUAL,2022-07-19,2022-03-18,ACTUAL,2022-03-18,,INTERVENTIONAL,,,Tricaprilin Liquid Formulation PK Study,"A Phase 1, Three-part, Part-randomised, Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Different Formulations of Tricaprilin, to Include Single-dose, Food Effect, and Titration Tolerability, in Healthy Participants",TERMINATED,,PHASE1,71.0,ACTUAL,Cerecin,,3.0,,"Part 1 was completed, Part 2 and Part 3 of the study were not conducted under this study protocol due to subject recruitment difficulty.",f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,INDUSTRY,,,,,,,2022,0.0
NCT03942601,,2019-05-06,,,2024-07-08,2019-05-06,2019-05-08,ACTUAL,,,,,,,2024-07-08,2024-07-10,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2024-07,2024-07-31,2021-04-30,ACTUAL,2021-04-30,2021-04-30,ACTUAL,2021-04-30,,INTERVENTIONAL,TAP-DANCE,,Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization,Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization,TERMINATED,,PHASE2,10.0,ACTUAL,"Mercator MedSystems, Inc.",,2.0,,Halted due to pandemic.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,INDUSTRY,,,,,,,2021,0.0
NCT03166631,,2017-05-23,,,2021-10-07,2017-05-24,2017-05-25,ACTUAL,,,,,,,2021-10-07,2021-10-14,ACTUAL,2017-09-08,ACTUAL,2017-09-08,2021-10,2021-10-31,2020-10-28,ACTUAL,2020-10-28,2020-09-15,ACTUAL,2020-09-15,,INTERVENTIONAL,,,A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread,"An Open-label Phase I Dose Finding Trial With BI 891065 Alone and in Combination With BI 754091 to Characterise Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Patients With Advanced and/or Metastatic Malignancies",TERMINATED,,PHASE1,62.0,ACTUAL,Boehringer Ingelheim,,3.0,,Not due to safety reasons.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,INDUSTRY,,,,,,,2020,0.0
NCT05979415,,2023-07-28,,,2024-03-11,2023-07-28,2023-08-07,ACTUAL,,,,,,,2024-03-11,2024-03-12,ACTUAL,2023-09-27,ACTUAL,2023-09-27,2024-03,2024-03-31,2024-02-28,ACTUAL,2024-02-28,2024-02-28,ACTUAL,2024-02-28,,INTERVENTIONAL,,,Study to Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Parkinson's Disease Experiencing OFF Episodes,"A Randomized, Double-Blind, to Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Parkinson's Disease Experiencing OFF Episodes",TERMINATED,,PHASE2,8.0,ACTUAL,"Alexza Pharmaceuticals, Inc.",,2.0,,Administrative decision,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,INDUSTRY,,,,,,,2024,0.0
NCT04958993,,2020-08-25,,,2022-02-09,2021-07-07,2021-07-12,ACTUAL,,,,,,,2022-02-09,2022-02-25,ACTUAL,2020-11-12,ACTUAL,2020-11-12,2022-02,2022-02-28,2021-11-22,ACTUAL,2021-11-22,2021-11-20,ACTUAL,2021-11-20,,INTERVENTIONAL,,,A Trial of Anlotinib Combined With Concurrent Chemoradiotherapy in Patients With Unresectable Stage III Non-small Cell Lung Cancer,A Phase I/II Clinical Study of Anlotinib Hydrochloride Capsule Combined With Concurrent Chemoradiotherapy in the Treatment of Unresectable Stage III Non-small Cell Lung Cancer,TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,Shandong Cancer Hospital and Institute,,1.0,,High incidence of severe radiation pneumonia,f,,,,,f,f,,,,,,,,,,,2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,OTHER,,,,,,,2021,0.0
NCT04282109,,2020-02-12,,,2024-08-29,2020-02-21,2020-02-24,ACTUAL,,,,,,,2024-08-29,2024-09-03,ACTUAL,2020-06-03,ACTUAL,2020-06-03,2024-08,2024-08-31,2024-03-21,ACTUAL,2024-03-21,2023-09-01,ACTUAL,2023-09-01,,INTERVENTIONAL,NIVOTAX,,Study to Assess the Efficacy and Safety of Nivolumab in Combination with Paclitaxel in Subjects with Head and Neck Cancer Unable for Cisplatin-based Chemotherapy (NIVOTAX),Phase II Multicenter Randomized Trial to Assess the Efficacy and Safety of First Line Nivolumab in Combination with Paclitaxel in Subjects with R/M HNSCC Unable for Cisplatin-based Chemotherapy (NIVOTAX),COMPLETED,,PHASE2,141.0,ACTUAL,Grupo Español de Tratamiento de Tumores de Cabeza y Cuello,,2.0,,,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,OTHER,,,,,,,2024,1.0
NCT03561090,,2018-06-07,2021-07-23,,2021-08-17,2018-06-07,2018-06-19,ACTUAL,2021-07-23,2021-08-18,ACTUAL,,,,2021-08-17,2021-08-19,ACTUAL,2018-06-20,ACTUAL,2018-06-20,2021-08,2021-08-31,2020-11-03,ACTUAL,2020-11-03,2020-10-07,ACTUAL,2020-10-07,,INTERVENTIONAL,,Safety Population: randomized participants who received at least 1 dose of study drug.,A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs),"A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients With Gastroesophageal Reflux Disease While Receiving Proton Pump Inhibitors",TERMINATED,,PHASE3,495.0,ACTUAL,"Ironwood Pharmaceuticals, Inc.",,2.0,,Parallel IW-3718 Phase III trial did not meet pre-specified criteria.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,INDUSTRY,,,,,,,2020,0.0
NCT04222257,,2019-12-19,,,2023-09-26,2020-01-07,2020-01-09,ACTUAL,,,,,,,2023-09-26,2023-09-28,ACTUAL,2021-01-26,ACTUAL,2021-01-26,2023-09,2023-09-30,2023-04-01,ACTUAL,2023-04-01,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,SATIE,,Short-course Antibiotic Treatment in Gram-positive Cocci Infective Endocarditis,Short-course Antibiotic Regimen Compared to Conventional Antibiotic Treatment for Gram-positive Cocci Infective Endocarditis: Randomized Clinical Trial,TERMINATED,,PHASE4,20.0,ACTUAL,"Hospital San Carlos, Madrid",,2.0,,Inability to reach the estimated sample size,f,,,,f,f,f,,,,,,,,,,,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,OTHER,,,,,,,2023,0.0
NCT05262387,,2022-02-24,2024-03-05,,2024-08-28,2022-02-24,2022-03-02,ACTUAL,2024-08-28,2024-09-03,ACTUAL,,,,2024-08-28,2024-09-03,ACTUAL,2022-02-14,ACTUAL,2022-02-14,2024-08,2024-08-31,2023-03-07,ACTUAL,2023-03-07,2023-03-07,ACTUAL,2023-03-07,,INTERVENTIONAL,,All participants who received at least one dose of study drug.,A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes,Effectiveness of a Basal Rate Reduction With LyumjevTM Versus Humalog® on the Protection From Exercise-Induced Hypoglycemia in Individuals With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion,COMPLETED,,PHASE1,25.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,INDUSTRY,,,,,,,2023,1.0
NCT02561117,,2015-09-23,,,2017-07-18,2015-09-24,2015-09-25,ESTIMATED,,,,,,,2017-07-18,2017-07-21,ACTUAL,2019-01,ESTIMATED,2019-01-31,2017-07,2017-07-31,2022-01,ESTIMATED,2022-01-31,2021-01,ESTIMATED,2021-01-31,,INTERVENTIONAL,METRO,,Once Daily Metronidazole for Perforated Appendicitis,Metronidazole Every 24 Hours as Part of Triple Antibiotic Therapy for Ruptured Appendicitis in Children Managed Operatively (METRO): a Noninferiority Randomized Controlled Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,Children's Hospital of Eastern Ontario,,2.0,,Lack of funding,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,OTHER,,,,,,,2022,0.0
NCT04434560,,2020-06-12,2022-06-10,,2022-07-22,2020-06-12,2020-06-17,ACTUAL,2022-07-22,2022-07-26,ACTUAL,,,,2022-07-22,2022-07-26,ACTUAL,2020-11-04,ACTUAL,2020-11-04,2022-07,2022-07-31,2021-06-17,ACTUAL,2021-06-17,2021-06-17,ACTUAL,2021-06-17,,INTERVENTIONAL,,No participants were enrolled in the Neoadjuvant Immunotherapy group.,Neoadjuvant Immunotherapy in Brain Metastases,"A Phase II Trial of Surgery and Stereotactic Radiosurgery With Neoadjuvant Nivolumab and Ipilimumab in Patients With Surgically-resectable, Solid Tumor Brain Metastases",TERMINATED,,PHASE2,1.0,ACTUAL,Duke University,,2.0,,Poor enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,OTHER,,,,,,,2021,0.0
NCT04791761,,2021-03-05,2024-07-02,,2024-08-29,2021-03-05,2021-03-10,ACTUAL,2024-08-15,2024-08-16,ACTUAL,,,,2024-08-29,2024-08-30,ACTUAL,2021-04-13,ACTUAL,2021-04-13,2024-08,2024-08-31,2023-07-03,ACTUAL,2023-07-03,2023-07-03,ACTUAL,2023-07-03,,INTERVENTIONAL,,Excludes patients withdrawn due to protocol violations.,Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy,Use of a Non-Opioid Pain Regimen for Post-Operative Analgesia Following Intracapsular Adenotonsillectomy,TERMINATED,,PHASE1/PHASE2,73.0,ACTUAL,University of Pittsburgh,Early termination due to slow recruitment leading to small numbers of subjects analyzed.,3.0,,slow recruitment,f,,,,f,t,f,,,f,,,,,,NO,Only co-investigators as listed under the University of Pittsburgh IRB (Institutional Review Board) protocol for this study will have access to all data and analysis. Data will be shared via UPMC-associated OneDrive and will only be shared between these investigators.,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,OTHER,,,,,,,2023,0.0
NCT01527747,,2012-01-31,,,2023-04-05,2012-02-06,2012-02-07,ESTIMATED,,,,,,,2023-04-05,2023-04-07,ACTUAL,2012-01,,2012-01-31,2023-04,2023-04-30,2024-12,ESTIMATED,2024-12-31,2024-11,ESTIMATED,2024-11-30,,INTERVENTIONAL,,,Effects of DPP-4 Inhibition on Triglycerides,Effects of Dipeptidyl Peptidase-4 Inhibition With Saxagliptin on Fasting and Postprandial Triglyceride Concentrations,SUSPENDED,,PHASE4,15.0,ACTUAL,Oregon Health and Science University,,2.0,,Funding,f,,,,f,,,,,,,,,,,NO,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,OTHER,,,,,,,2024,0.0
NCT03252587,,2017-08-15,2022-06-29,,2022-11-28,2017-08-15,2017-08-17,ACTUAL,2022-08-16,2022-09-10,ACTUAL,,,,2022-11-28,2022-12-20,ACTUAL,2017-09-21,ACTUAL,2017-09-21,2022-11,2022-11-30,2021-10-28,ACTUAL,2021-10-28,2021-06-29,ACTUAL,2021-06-29,,INTERVENTIONAL,,,An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus",COMPLETED,,PHASE2,363.0,ACTUAL,Bristol-Myers Squibb,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,INDUSTRY,,,,,,,2021,1.0
NCT01776840,,2013-01-24,2022-06-30,,2024-08-04,2013-01-24,2013-01-28,ESTIMATED,2022-06-30,2022-07-26,ACTUAL,,,,2024-08-04,2024-08-28,ACTUAL,2013-05-16,ACTUAL,2013-05-16,2024-08,2024-08-31,2024-06-24,ACTUAL,2024-06-24,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,,,A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma,"A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma",COMPLETED,,PHASE3,523.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,,f,,,,t,,f,,,,,,,,,,,2024-10-16 21:24:29.407204,2024-10-16 21:24:29.407204,INDUSTRY,,,,,,,2024,1.0
NCT04956276,,2021-06-30,,,2022-02-02,2021-06-30,2021-07-09,ACTUAL,,,,,,,2022-02-02,2022-02-11,ACTUAL,2022-01-01,ESTIMATED,2022-01-01,2022-02,2022-02-28,2024-07-31,ESTIMATED,2024-07-31,2022-07-31,ESTIMATED,2022-07-31,,INTERVENTIONAL,,,Subcutaneous ALXN1830 in Adult Participants With Warm Autoimmune Hemolytic Anemia,"A Phase 2, Multiple Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study of ALXN1830 Administered Subcutaneously in Patients With Warm Autoimmune Hemolytic Anemia (WAIHA)",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,3.0,,Sponsor decision to terminate program,f,,,,f,t,f,,,,,,,,,YES,,2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,INDUSTRY,,,,,,,2024,0.0
NCT02450331,,2015-05-19,2020-10-21,,2023-05-22,2015-05-19,2015-05-21,ESTIMATED,2020-11-13,2020-11-18,ACTUAL,,,,2023-05-22,2023-06-18,ACTUAL,2015-10-05,ACTUAL,2015-10-05,2023-05,2023-05-31,2022-06-14,ACTUAL,2022-06-14,2019-11-30,ACTUAL,2019-11-30,,INTERVENTIONAL,IMvigor010,,A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection,"A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection",TERMINATED,,PHASE3,809.0,ACTUAL,Hoffmann-La Roche,,2.0,,Sponsor decided to terminate the study early because the study did not meet its primary endpoint and because the study had met its goals of providing safety and additional exploratory efficacy information for atezolizumab monotherapy in MIBC.,f,,,,,,,,,,,,,,,,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,INDUSTRY,,,,,,,2022,0.0
NCT04341311,,2020-03-05,,,2024-02-14,2020-04-08,2020-04-10,ACTUAL,,,,,,,2024-02-14,2024-02-15,ACTUAL,2020-08-10,ACTUAL,2020-08-10,2024-02,2024-02-29,2024-02-14,ACTUAL,2024-02-14,2024-02-14,ACTUAL,2024-02-14,,INTERVENTIONAL,DIPG,,Phase I Study of Marizomib + Panobinostat for Children With DIPG,Phase 1 Trial of Marizomib Alone and in Combination With Panobinostat for Children With Diffuse Intrinsic Pontine Glioma,TERMINATED,,PHASE1,4.0,ACTUAL,Dana-Farber Cancer Institute,,2.0,,Withdrawal of support from BMS,f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,OTHER,,,,,,,2024,0.0
NCT02687451,,2016-01-14,2021-08-10,,2021-09-28,2016-02-17,2016-02-22,ESTIMATED,2021-09-28,2021-10-26,ACTUAL,,,,2021-09-28,2021-10-26,ACTUAL,2016-04,ACTUAL,2016-04-30,2021-01,2021-01-31,2020-09-15,ACTUAL,2020-09-15,2020-07-01,ACTUAL,2020-07-01,,INTERVENTIONAL,,,"Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects","An Open-Label Single-Dose And Randomized, Double-Blind, Placebo-Controlled Multiple-Dose Study To Evaluate The Efficacy, Safety, Tolerability, And Pharmacokinetics Of Oxymorphone Hydrochloride (HCl) For Acute Moderate To Severe Postoperative Pain In Pediatric Subjects",TERMINATED,,PHASE3,28.0,ACTUAL,Endo Pharmaceuticals,,3.0,,Released from PMR,f,,,,t,,,,,,,,,,,,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,INDUSTRY,,,,,,,2020,0.0
NCT03430947,,2018-01-10,,,2023-09-12,2018-02-06,2018-02-13,ACTUAL,,,,,,,2023-09-12,2023-09-14,ACTUAL,2018-07-01,ACTUAL,2018-07-01,2023-09,2023-09-30,2023-02-10,ACTUAL,2023-02-10,2023-02-10,ACTUAL,2023-02-10,,INTERVENTIONAL,RadioCoBRIM,,Vemurafenib Plus Cobimetinib After Radiosurgery in Patients With BRAF-mutant Melanoma Brain Metastases,An Open-label Phase II Multicenter Study of Vemurafenib (Zelboraf®) Plus Cobimetinib (Cotellic®) After Radiosurgery in Patients With Active BRAF-V600-mutant Melanoma Brain Metastases,TERMINATED,,PHASE2,20.0,ACTUAL,Technische Universität Dresden,,1.0,,"Due to insufficient recruitment, the clinical trial was terminated prematurely",f,,,,t,f,f,,,,,,within 5 years,,,YES,"After publication of the primary objective, the data might be provided to interested scientists on request (e.g. for meta-analyses or other scientific research) in an anonymized way within 5 years (according to the General Data Protection Regulation), provided that the sponsor and the coordinating principal investigators have given their prior written consent.",2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,OTHER,,,,,,,2023,0.0
NCT04550338,,2020-09-13,,,2021-04-21,2020-09-13,2020-09-16,ACTUAL,,,,,,,2021-04-21,2021-04-23,ACTUAL,2021-08-01,ESTIMATED,2021-08-01,2021-04,2021-04-30,2023-03-31,ESTIMATED,2023-03-31,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,TXACOVIDPREV,,Antiviral Effects of TXA as a Preventative Treatment Following COVID-19 Exposure,Antiviral Effects of Tranexamic Acid (TXA) as a Preventative Treatment Following COVID-19 Exposure,WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Alabama at Birmingham,,2.0,,"With vaccination efforts ongoing, a feasibility survey indicated there would be inadequate recruitment",f,,,,t,t,f,,,t,,,within one month of request,institutional approval,,YES,all de-identified data would be available upon request,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,OTHER,,,,,,,2023,0.0
NCT00127205,,2005-08-03,2019-06-20,,2021-06-08,2005-08-03,2005-08-05,ESTIMATED,2019-08-15,2019-08-28,ACTUAL,,,,2021-06-08,2021-07-02,ACTUAL,2005-07,,2005-07-31,2021-06,2021-06-30,2021-03-29,ACTUAL,2021-03-29,2017-12,ACTUAL,2017-12-31,,INTERVENTIONAL,,Only eligible patients are included in the analysis.,S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.,Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer,COMPLETED,,PHASE3,6097.0,ACTUAL,SWOG Cancer Research Network,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,NETWORK,,,,,,,2021,1.0
NCT01528618,,2012-01-31,,,2021-09-27,2012-02-04,2012-02-08,ESTIMATED,,,,,,,2021-09-27,2021-10-04,ACTUAL,2012-02-21,ACTUAL,2012-02-21,2021-09,2021-09-30,2020-12-20,ACTUAL,2020-12-20,2016-04-10,ACTUAL,2016-04-10,,INTERVENTIONAL,,,Effect and Safety Study of GP/FP Regimens in Advanced Nasopharyngeal Carcinoma,"A Randomized, Multicenter Phase III Clinical Trial Comparing Gemcitabine and Cisplatin With 5-Fluorouracil and Cisplatin in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)",COMPLETED,,PHASE3,362.0,ACTUAL,Sun Yat-sen University,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,OTHER,,,,,,,2020,1.0
NCT04225533,,2020-01-08,2022-12-08,2022-01-07,2023-01-04,2020-01-08,2020-01-13,ACTUAL,2023-01-04,2023-01-30,ACTUAL,2023-01-04,2023-01-30,ACTUAL,2023-01-04,2023-01-30,ACTUAL,2020-02-24,ACTUAL,2020-02-24,2023-01,2023-01-31,2021-12-21,ACTUAL,2021-12-21,2021-01-04,ACTUAL,2021-01-04,,INTERVENTIONAL,SPIRIT,,SP16 Inflammatory Response Inhibition Trial,SP16 Inflammatory Response Inhibition Trial,COMPLETED,,PHASE1/PHASE2,10.0,ACTUAL,"Serpin Pharma, LLC",,1.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,OTHER,,,,,,,2021,1.0
NCT02768532,,2016-05-02,,,2023-06-13,2016-05-10,2016-05-11,ESTIMATED,,,,,,,2023-06-13,2023-06-15,ACTUAL,2016-07-01,ACTUAL,2016-07-01,2023-02,2023-02-28,2023-01-23,ACTUAL,2023-01-23,2022-01-11,ACTUAL,2022-01-11,,INTERVENTIONAL,VEDO-PREDIRESP,,Value of Pharmacokinetic Assays in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease,VEDO-PREDIRESP Project: Value of Pharmacokinetic Assays (Vedolizumab and Anti-vedolizumab Antibody) in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease,TERMINATED,,PHASE4,47.0,ACTUAL,Centre Hospitalier Universitaire de Saint Etienne,,1.0,,low inclusion rates,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,OTHER,,,,,,,2023,0.0
NCT02995642,,2016-12-14,,,2021-05-19,2016-12-15,2016-12-16,ESTIMATED,,,,,,,2021-05-19,2021-05-21,ACTUAL,2019-10,ESTIMATED,2019-10-31,2021-05,2021-05-31,2020-12,ESTIMATED,2020-12-31,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,Targeted PET/CT and PET/MRI Imaging of Vascular Inflammation,Targeted PET/CT and PET/MRI Imaging of Vascular Inflammation,WITHDRAWN,,PHASE2,0.0,ACTUAL,Stanford University,,1.0,,Resources not secured,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,OTHER,,,,,,,2020,0.0
NCT04927884,,2021-06-09,2024-04-03,,2024-06-11,2021-06-09,2021-06-16,ACTUAL,2024-06-11,2024-06-12,ACTUAL,,,,2024-06-11,2024-06-12,ACTUAL,2021-09-08,ACTUAL,2021-09-08,2024-06,2024-06-30,2022-12-12,ACTUAL,2022-12-12,2022-09-13,ACTUAL,2022-09-13,,INTERVENTIONAL,,,A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies,Open-Label Phase 1b/2 Study of Sacituzumab Govitecan-Hziy Plus Chemoimmunotherapy for the Treatment of Subjects With Advanced Triple-Negative Breast Cancer After Prior Therapy,TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,"ImmunityBio, Inc.",The study was terminated early due to low enrollment. Only the safety data is provided.,1.0,,low enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,INDUSTRY,,,,,,,2022,0.0
NCT05049850,,2021-09-09,,,2024-08-29,2021-09-09,2021-09-20,ACTUAL,,,,,,,2024-08-29,2024-08-30,ACTUAL,2022-12-16,ACTUAL,2022-12-16,2023-11,2023-11-30,2024-05-08,ACTUAL,2024-05-08,2024-02-05,ACTUAL,2024-02-05,,INTERVENTIONAL,,,A Study to Investigate DSA Rebound in Patients Treated with Imlifidase Prior to Transplantation,"An Open Label, Phase II Study to Investigate DSA Rebound in Patients with a Positive Crossmatch, Made Transplantable with Imlifidase",TERMINATED,,PHASE2,3.0,ACTUAL,Hansa Biopharma AB,,1.0,,"Company decision, not due to any safety reason",f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,INDUSTRY,,,,,,,2024,0.0
NCT03091998,,2017-03-09,,,2017-07-25,2017-03-21,2017-03-27,ACTUAL,,,,,,,2017-07-25,2017-07-28,ACTUAL,2017-09-30,ESTIMATED,2017-09-30,2017-07,2017-07-31,2020-05-01,ESTIMATED,2020-05-01,2019-05-01,ESTIMATED,2019-05-01,,INTERVENTIONAL,CD-NP/LVAD,,Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support,A Phase I Trial to Determine Safety and Efficacy of Chronic Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support,WITHDRAWN,,PHASE1,0.0,ACTUAL,Mayo Clinic,,2.0,,No funding available,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-14 23:36:02.364973,2024-10-14 23:36:02.364973,OTHER,,,,,,,2020,0.0
NCT03737344,,2018-10-18,,,2021-10-04,2018-11-08,2018-11-09,ACTUAL,,,,,,,2021-10-04,2021-10-05,ACTUAL,2019-05-17,ACTUAL,2019-05-17,2021-10,2021-10-31,2021-04-30,ACTUAL,2021-04-30,2021-02-19,ACTUAL,2021-02-19,,INTERVENTIONAL,BLOC-ICH,,BLOC-ICH: Interleukin-1 Receptor Antagonist in Intracerebral Haemorrhage,Phase II Trial of Interleukin-1 Receptor Antagonist in Intracerebral Haemorrhage: BLOcking the Cytokine IL-1 in ICH,COMPLETED,,PHASE2,25.0,ACTUAL,University of Manchester,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,OTHER,,,,,,,2021,1.0
NCT04131322,,2019-10-10,,,2021-01-11,2019-10-17,2019-10-18,ACTUAL,,,,,,,2021-01-11,2021-01-12,ACTUAL,2019-10-10,ACTUAL,2019-10-10,2021-01,2021-01-31,2020-06-08,ACTUAL,2020-06-08,2020-06-08,ACTUAL,2020-06-08,,INTERVENTIONAL,ADA-SWITCH,,"Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.","Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. ADA-SWITCH Study",TERMINATED,,PHASE4,24.0,ACTUAL,Fundación Pública Andaluza para la gestión de la Investigación en Sevilla,,2.0,,Sponsor cancellation,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 23:41:57.744149,2024-10-14 23:41:57.744149,OTHER,,,,,,,2020,0.0
NCT03466333,,2018-03-08,,,2021-02-23,2018-03-08,2018-03-15,ACTUAL,,,,,,,2021-02-23,2021-02-24,ACTUAL,2018-09-05,ACTUAL,2018-09-05,2021-02,2021-02-28,2020-09-11,ACTUAL,2020-09-11,2020-09-11,ACTUAL,2020-09-11,,INTERVENTIONAL,PICk-UP,,Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia,Feasibility Study on the Effects of Postnatal Enalapril on Maternal Cardiovascular Function Following Preterm Pre-eclampsia.,COMPLETED,,PHASE2,118.0,ACTUAL,Manchester University NHS Foundation Trust,,3.0,,,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,OTHER_GOV,,,,,,,2020,1.0
NCT05580250,,2022-10-12,,,2023-01-06,2022-10-12,2022-10-14,ACTUAL,,,,,,,2023-01-06,2023-01-09,ACTUAL,2022-11-22,ACTUAL,2022-11-22,2023-01,2023-01-31,2022-12-08,ACTUAL,2022-12-08,2022-12-08,ACTUAL,2022-12-08,,INTERVENTIONAL,,,A Study of LY3526318 in Healthy Male Japanese Participants,"A Phase I, Single-Centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of LY3526318, and to Investigate the Effect of LY3526318 on Metformin and Simvastatin Pharmacokinetics in Healthy Male Japanese Participants",WITHDRAWN,,PHASE1,0.0,ACTUAL,Eli Lilly and Company,,5.0,,The sponsor made a business decision to withdraw the trial.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,INDUSTRY,,,,,,,2022,0.0
NCT02611908,,2015-11-19,,,2019-01-23,2015-11-19,2015-11-23,ESTIMATED,,,,,,,2019-01-23,2019-01-25,ACTUAL,2016-06,,2016-06-30,2019-01,2019-01-31,2020-11,ESTIMATED,2020-11-30,2019-11,ESTIMATED,2019-11-30,,INTERVENTIONAL,,,Obinutuzumab With High-dose Ibrutinib for the Treatment of Patients With Chronic Lymphocytic Leukemia With Progressive Disease on Single Agent Ibrutinib.,A Phase 1 Clinical Trial to Evaluate Obinutuzumab With High-dose Ibrutinib for the Treatment of Patients With Chronic Lymphocytic Leukemia With Progressive Disease on Single Agent Ibrutinib.,WITHDRAWN,,PHASE1,0.0,ACTUAL,"University of California, San Diego",,1.0,,No participants enrolled,f,,,,t,t,f,,,,,,,,,,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,OTHER,,,,,,,2020,0.0
NCT03954704,,2019-05-15,2023-02-10,,2023-02-10,2019-05-15,2019-05-17,ACTUAL,2023-02-10,2023-11-21,ACTUAL,,,,2023-02-10,2023-11-21,ACTUAL,2019-06-03,ACTUAL,2019-06-03,2023-02,2023-02-28,2021-04-15,ACTUAL,2021-04-15,2020-10-27,ACTUAL,2020-10-27,,INTERVENTIONAL,,The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.,Study of Dalutrafusp Alfa (Formerly GS-1423) in Participants With Advanced Solid Tumors,"A Phase 1a/1b Study of GS-1423, an Anti-CD73-TGFβ-Trap Bifunctional Antibody, as Monotherapy or in Combination With a Chemotherapy Regimen in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,22.0,ACTUAL,Gilead Sciences,"Because the study was terminated after enrolling only 22 participants in the dose-escalation stage (Phase 1a Part A), planned analysis was not conducted for Phase 1a Part B, and Phase 1b.",4.0,,"The decision to discontinue the study was made based on the totality of the clinical, pharmacokinetic, and pharmacodynamic findings. No safety concerns were observed.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,INDUSTRY,,,,,,,2021,0.0
NCT04243551,,2020-01-23,,,2024-08-01,2020-01-24,2020-01-28,ACTUAL,,,,,,,2024-08-01,2024-08-05,ACTUAL,2019-11-01,ACTUAL,2019-11-01,2023-07,2023-07-31,2023-10-31,ACTUAL,2023-10-31,2023-10-16,ACTUAL,2023-10-16,,INTERVENTIONAL,,,"Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients","Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet While Undergoing Periodic Gluten Exposure",TERMINATED,,PHASE2,83.0,ACTUAL,Entero Therapeutics,,2.0,,Due to low enrollment related to Covid.,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,INDUSTRY,,,,,,,2023,0.0
NCT04599075,,2020-10-16,2024-06-06,,2024-07-02,2020-10-21,2020-10-22,ACTUAL,2024-07-02,2024-07-08,ACTUAL,,,,2024-07-02,2024-07-08,ACTUAL,2021-03-15,ACTUAL,2021-03-15,2024-07,2024-07-31,2023-05-02,ACTUAL,2023-05-02,2023-05-01,ACTUAL,2023-05-01,,INTERVENTIONAL,,,Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus,Intravenous Insulin Versus Subcutaneous Insulin Infusion in Intrapartum Management of Pregnant Women With Type 1 Diabetes Mellitus: A Randomized Trial,COMPLETED,,PHASE4,70.0,ACTUAL,"University of Massachusetts, Worcester",,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,OTHER,,,,,,,2023,1.0
NCT03037593,,2017-01-27,,,2019-10-30,2017-01-30,2017-01-31,ESTIMATED,,,,,,,2019-10-30,2019-11-01,ACTUAL,2017-06-01,ACTUAL,2017-06-01,2019-10,2019-10-31,2020-06,ESTIMATED,2020-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,High Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High Risk Pregnant Women,A Randomized Single-Center Study of the Effects of High-Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High-Risk Pregnant Women,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Minnesota,,2.0,,Failure to recruit adequate patients,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,OTHER,,,,,,,2020,0.0
NCT03393000,,2017-12-26,2021-05-18,,2021-07-01,2018-01-04,2018-01-08,ACTUAL,2021-07-01,2021-07-22,ACTUAL,,,,2021-07-01,2021-07-22,ACTUAL,2018-01-16,ACTUAL,2018-01-16,2021-07,2021-07-31,2020-11-06,ACTUAL,2020-11-06,2020-11-06,ACTUAL,2020-11-06,,INTERVENTIONAL,INTACT,,Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects,"Open-label, Randomized, Controlled, Phase 3 Safety and Efficacy Study of Trans Sodium Crocetinate With Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects",TERMINATED,,PHASE3,19.0,ACTUAL,Diffusion Pharmaceuticals Inc,"The 100-206 trial was an open-label, dose-escalation safety run-in for what was originally planned as a larger randomized trial. 19 pts were enrolled to ensure that at least 8 pts completed the FDA-specified 24-mo. exposure period. At its Q3 2019 meeting, the DSMB found no adverse safety signal and recommended the trial continue as planned. However, the Sponsor did not have resources to fully support the randomized phase of the study and enrollment in the randomized phase was suspended.",2.0,,Business decision on behalf of the Sponsor.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,INDUSTRY,,,,,,,2020,0.0
NCT02880956,,2016-08-24,2022-07-05,2022-02-03,2022-08-04,2016-08-24,2016-08-26,ESTIMATED,2022-08-04,2022-08-26,ACTUAL,2022-08-04,2022-08-26,ACTUAL,2022-08-04,2022-08-26,ACTUAL,2017-01-26,ACTUAL,2017-01-26,2022-08,2022-08-31,2021-07-28,ACTUAL,2021-07-28,2021-03-30,ACTUAL,2021-03-30,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease,"A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease",COMPLETED,,PHASE2,453.0,ACTUAL,AbbVie,,4.0,,,t,,,,t,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,INDUSTRY,,NCT03744546,NO_LONGER_AVAILABLE,,,,2021,1.0
NCT03982186,,2019-06-10,2024-03-27,2022-03-28,2024-07-05,2019-06-10,2019-06-11,ACTUAL,2024-07-05,2024-07-10,ACTUAL,,2024-07-10,ACTUAL,2024-07-05,2024-07-10,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2024-07,2024-07-31,2022-04-26,ACTUAL,2022-04-26,2021-03-29,ACTUAL,2021-03-29,,INTERVENTIONAL,REEF-1,Intent to treat (ITT) set included all participants who were randomly assigned to any of the 6 intervention arms and received at least 1 dose of study intervention.,A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection,"A Phase 2b, Multicenter, Double-blind, Active-controlled, Randomized Study to Investigate the Efficacy and Safety of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection",COMPLETED,,PHASE2,471.0,ACTUAL,Janssen Sciences Ireland UC,,6.0,,,f,,,,t,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,INDUSTRY,,,,,,,2022,1.0
NCT02533180,,2015-08-21,2021-02-10,,2023-09-08,2015-08-25,2015-08-26,ESTIMATED,2021-02-10,2021-03-05,ACTUAL,,,,2023-09-08,2023-09-14,ACTUAL,2015-12-15,ACTUAL,2015-12-15,2023-09,2023-09-30,2022-07-08,ACTUAL,2022-07-08,2020-02-10,ACTUAL,2020-02-10,,INTERVENTIONAL,OPTIMAL,,Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liver Transplantation,Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Operational Tolerance Following Liver Transplantation in Adults (ITN056ST),COMPLETED,,PHASE2,100.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,1.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,NIH,,,,,,,2022,1.0
NCT04828174,,2021-03-31,,,2023-11-26,2021-03-31,2021-04-01,ACTUAL,,,,,,,2023-11-26,2023-11-29,ACTUAL,2021-03-31,ACTUAL,2021-03-31,2023-11,2023-11-30,2023-11-26,ESTIMATED,2023-11-26,2023-11-26,ESTIMATED,2023-11-26,,INTERVENTIONAL,,,Anti-TRBC1 CAR-T Cell Therapy in Patients With TRBC1 Positive T Cell Malignancies,The Safety and Clinical Efficacy of Human TRBC1 CAR-T Cell Therapy for Patients With Relapsed/Refractory TRBC1 Positive T Cell Hematological Maliganacies,SUSPENDED,,PHASE1,9.0,ESTIMATED,"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",,1.0,,The trial was suspended due to the inability to enroll qualified participants,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 20:28:22.395127,2024-10-16 20:28:22.395127,OTHER,,,,,,,2023,0.0
NCT04781374,,2021-02-26,,,2023-07-07,2021-03-01,2021-03-04,ACTUAL,,,,,,,2023-07-07,2023-07-11,ACTUAL,2021-05-21,ACTUAL,2021-05-21,2023-07,2023-07-31,2021-09-24,ACTUAL,2021-09-24,2021-09-24,ACTUAL,2021-09-24,,INTERVENTIONAL,,,Neratinib in Patients With Metastatic Castration-Resistant Prostate Cancer,A Phase 2 Study of Neratinib in Patients With Metastatic Castration Resistant Prostate Cancer and Increased Human Epithelial Growth Factor Receptor 2 (HER2) Signaling,WITHDRAWN,,PHASE2,0.0,ACTUAL,Beth Israel Deaconess Medical Center,,1.0,,Withdrawal of funding,f,,,,t,t,f,,,t,,,Data can be shared no earlier than 1 year following the date of publication,Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,OTHER,,,,,,,2021,0.0
NCT05338723,,2022-04-04,,,2024-02-27,2022-04-18,2022-04-21,ACTUAL,,,,,,,2024-02-27,2024-02-28,ACTUAL,2020-09-15,ACTUAL,2020-09-15,2024-02,2024-02-29,2023-09-15,ACTUAL,2023-09-15,2023-09-15,ACTUAL,2023-09-15,,INTERVENTIONAL,,,Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients,Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients,COMPLETED,,PHASE3,50.0,ACTUAL,Tanta University,,2.0,,,f,,,,,f,f,,,f,,,,,,NO,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,OTHER,,,,,,,2023,1.0
NCT03991208,,2019-06-14,,,2021-04-27,2019-06-17,2019-06-19,ACTUAL,,,,,,,2021-04-27,2021-04-30,ACTUAL,2019-05-24,ESTIMATED,2019-05-24,2021-04,2021-04-30,2021-05-23,ESTIMATED,2021-05-23,2021-05-23,ESTIMATED,2021-05-23,,INTERVENTIONAL,MPUSPSD,,Malarone Pharmacokinetics Under Simulated Physiologic Stressors of Deployment,Malarone Pharmacokinetics Under Simulated Physiologic Stressors of Deployment,WITHDRAWN,,PHASE4,0.0,ACTUAL,Walter Reed Army Institute of Research (WRAIR),,2.0,,Unable to recruit,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,FED,,,,,,,2021,0.0
NCT05087381,,2021-10-19,,,2022-11-01,2021-10-19,2021-10-21,ACTUAL,,,,,,,2022-11-01,2022-11-04,ACTUAL,2021-10-01,ACTUAL,2021-10-01,2022-11,2022-11-30,2022-06-21,ACTUAL,2022-06-21,2022-06-21,ACTUAL,2022-06-21,,INTERVENTIONAL,,,Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community,"Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community With Fluvoxamine, Bromhexine, Cyproheptadine, and Niclosamide in Decreasing Recovery Time",COMPLETED,,PHASE4,1200.0,ACTUAL,Chulalongkorn University,,6.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,OTHER,,,,,,,2022,1.0
NCT06147908,,2023-11-15,,,2023-11-19,2023-11-19,2023-11-28,ACTUAL,,,,,,,2023-11-19,2023-11-28,ACTUAL,2022-07-01,ACTUAL,2022-07-01,2023-11,2023-11-30,2022-11-17,ACTUAL,2022-11-17,2022-10-26,ACTUAL,2022-10-26,,INTERVENTIONAL,,,Clinical Trial to Evaluate the Pharmacokinetic Characteristics of DW5221 and DW5221-R,A Bioequivalence Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DW5221 and DW5221-R in Healthy Adult Male Volunteers,COMPLETED,,PHASE1,54.0,ACTUAL,"Daewon Pharmaceutical Co., Ltd.",,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 00:04:35.083684,2024-10-16 00:04:35.083684,INDUSTRY,,,,,,,2022,1.0
NCT03832816,,2019-02-05,,,2019-08-01,2019-02-05,2019-02-06,ACTUAL,,,,,,,2019-08-01,2019-08-05,ACTUAL,2019-12,ESTIMATED,2019-12-31,2019-08,2019-08-31,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Behavioral and Physiological Effects of THC and CBD,Behavioral and Physiological Effects of delta9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD),WITHDRAWN,,PHASE1,0.0,ACTUAL,Johns Hopkins University,,8.0,,cancellation of funding contract,f,,,,f,t,f,,,,,,,,,,,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,OTHER,,,,,,,2021,0.0
NCT03860974,,2019-02-28,2022-02-11,,2022-08-26,2019-02-28,2019-03-04,ACTUAL,2022-08-26,2022-09-21,ACTUAL,,,,2022-08-26,2022-09-21,ACTUAL,2019-05-09,ACTUAL,2019-05-09,2022-08,2022-08-31,2021-02-13,ACTUAL,2021-02-13,2021-02-12,ACTUAL,2021-02-12,,INTERVENTIONAL,,,Serratus Plane Versus Paravertebral Nerve Blocks for Breast Surgery,"A Randomized, Subject-Masked, Active-Controlled, Parallel-Arm Clinical Trial Comparing Serratus Plane and Paravertebral Nerve Blocks",COMPLETED,,PHASE4,100.0,ACTUAL,"University of California, San Diego","\*\* Regarding the time from nerve block placement until block resolution, this outcome was erroneously left off of the case report forms, so we did not collect the data for this outcome measure.",2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,OTHER,,,,,,,2021,1.0
NCT04540705,,2020-09-03,,,2024-02-26,2020-09-03,2020-09-07,ACTUAL,,,,,,,2024-02-26,2024-02-28,ACTUAL,2020-09-11,ACTUAL,2020-09-11,2024-02,2024-02-29,2024-01-18,ACTUAL,2024-01-18,2024-01-18,ACTUAL,2024-01-18,,INTERVENTIONAL,PIVOT IO 011,,A Study to Compare Bempegaldesleukin (BEMPEG: NKTR-214) Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread,A Phase 1 Study to Compare Bempegaldesleukin Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (mRCC) (PIVOT IO 011),COMPLETED,,PHASE1,30.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,INDUSTRY,,,,,,,2024,0.0
NCT03369717,,2017-12-06,,,2022-02-03,2017-12-06,2017-12-12,ACTUAL,,,,,,,2022-02-03,2022-02-07,ACTUAL,2018-08-01,ACTUAL,2018-08-01,2022-02,2022-02-28,2023-07,ESTIMATED,2023-07-31,2023-01,ESTIMATED,2023-01-31,,INTERVENTIONAL,,,Use of Perioperative Antibiotics in Endoscopic Sinus Surgery,Use of Perioperative Antibiotics in Endoscopic Sinus Surgery,SUSPENDED,,PHASE4,400.0,ESTIMATED,Montefiore Medical Center,,2.0,,Expired IRB approval since 05/07/2020,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,OTHER,,,,,,,2023,0.0
NCT04472819,,2020-07-09,,,2021-09-26,2020-07-12,2020-07-15,ACTUAL,,,,,,,2021-09-26,2021-09-28,ACTUAL,2020-08-28,ACTUAL,2020-08-28,2021-09,2021-09-30,2021-05-31,ACTUAL,2021-05-31,2021-05-31,ACTUAL,2021-05-31,,INTERVENTIONAL,,,"The Single, Multiple Dose and Food Effect Study of SHR2285 Tablets on Pharmacokinetics and Pharmacodynamics in Healthy Subjects","A Phase I, Randomized, Double -Blinded, Placebo-Controlled, Single and Multiple Dose and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets in Healthy Subjects",COMPLETED,,PHASE1,104.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,6.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,INDUSTRY,,,,,,,2021,1.0
NCT03355326,,2017-10-24,2021-07-20,,2021-09-15,2017-11-27,2017-11-28,ACTUAL,2021-09-15,2021-10-12,ACTUAL,,,,2021-09-15,2021-10-12,ACTUAL,2017-10-01,ACTUAL,2017-10-01,2021-09,2021-09-30,2020-10-01,ACTUAL,2020-10-01,2020-10-01,ACTUAL,2020-10-01,,INTERVENTIONAL,,,Evaluation of Glycerin Suppositories to Improve Bowel Function in Gastroschisis,Evaluation of Routine Administration of Glycerin Suppositories to Improve Bowel Function in Patients With Uncomplicated Gastroschisis,TERMINATED,,PHASE4,16.0,ACTUAL,Indiana University,,2.0,,Unable to sufficiently recruit candidates,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,OTHER,,,,,,,2020,0.0
NCT03864627,,2019-03-05,2020-12-08,,2020-12-08,2019-03-05,2019-03-06,ACTUAL,2020-12-08,2021-01-05,ACTUAL,,,,2020-12-08,2021-01-05,ACTUAL,2019-03-25,ACTUAL,2019-03-25,2020-12,2020-12-31,2020-02-27,ACTUAL,2020-02-27,2020-02-27,ACTUAL,2020-02-27,,INTERVENTIONAL,GECKO,The safety analysis set included all participants who received at least one dose of investigational medicinal product (IMP).,"A Study to Evaluate the Safety and Tolerability of MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Participants With Moderate to Severe Atopic Dermatitis","A Randomized, Double-blind, Placebo-controlled, Multicentre Phase 2 Study to Evaluate the Safety and Tolerability of Subcutaneous MOR106 Administered Concomitantly With Topical Corticosteroids for Eight Weeks, in Adult Subjects With Moderate to Severe Atopic Dermatitis",TERMINATED,,PHASE2,33.0,ACTUAL,Galapagos NV,"The study was terminated as MOR106, clinical development in atopic dermatitis was stopped for futility.",2.0,,MOR106 clinical development in atopic dermatitis was stopped for futility,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,INDUSTRY,,,,,,,2020,0.0
NCT04258592,,2020-02-03,,,2022-08-09,2020-02-03,2020-02-06,ACTUAL,,,,,,,2022-08-09,2022-08-12,ACTUAL,2020-02-07,ACTUAL,2020-02-07,2022-08,2022-08-31,2022-07-07,ACTUAL,2022-07-07,2022-07-07,ACTUAL,2022-07-07,,INTERVENTIONAL,,,18F-MFBG PET Imaging of the Norepinephrine Transporter in Neural Crest and Neuroendocrine Tumors,18F-MFBG PET Imaging of the Norepinephrine Transporter in Neural Crest and Neuroendocrine Tumors: a Phase I PET/CT Study,TERMINATED,,PHASE1,6.0,ACTUAL,Universitaire Ziekenhuizen KU Leuven,,1.0,,Insufficient recruitment,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,OTHER,,,,,,,2022,0.0
NCT01814813,,2013-03-18,2019-04-08,,2023-05-02,2013-03-18,2013-03-20,ESTIMATED,2019-05-17,2019-06-12,ACTUAL,,,,2023-05-02,2023-05-06,ACTUAL,2013-05,ACTUAL,2013-05-31,2023-05,2023-05-31,2023-05-01,ACTUAL,2023-05-01,2017-04-03,ACTUAL,2017-04-03,,INTERVENTIONAL,,,Vaccine Therapy With Bevacizumab Versus Bevacizumab Alone in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery,"A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96) (NSC #725085, ALLIANCE IND # 15380) Vaccine Given With Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)",TERMINATED,,PHASE2,90.0,ACTUAL,Alliance for Clinical Trials in Oncology,,3.0,,DSMB futility analysis,f,,,,t,,,,,,,,,,,,,2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,OTHER,,,,,,,2023,0.0
NCT04539262,,2020-08-26,2022-02-18,,2022-02-18,2020-09-03,2020-09-04,ACTUAL,2022-02-18,2022-03-03,ACTUAL,,,,2022-02-18,2022-03-03,ACTUAL,2020-09-14,ACTUAL,2020-09-14,2022-02,2022-02-28,2021-03-22,ACTUAL,2021-03-22,2021-02-26,ACTUAL,2021-02-26,,INTERVENTIONAL,,The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment.,"Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation","A Phase 1b/2a Study in Participants With Early Stage COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation",COMPLETED,,PHASE1/PHASE2,156.0,ACTUAL,Gilead Sciences,,8.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 09:57:52.147108,2024-10-16 09:57:52.147108,INDUSTRY,,,,,,,2021,1.0
NCT03315897,,2017-10-17,,,2023-03-15,2017-10-17,2017-10-20,ACTUAL,,,,,,,2023-03-15,2023-03-16,ACTUAL,2017-07-05,ACTUAL,2017-07-05,2023-03,2023-03-31,2022-10-01,ACTUAL,2022-10-01,2022-10-01,ACTUAL,2022-10-01,,INTERVENTIONAL,PreTEC-EPO,,Effects of Erythropoietin on Cognition and Neural Activity in Mood Disorders,"Effects of Erythropoietin on Cognitive Functions and Neural Activity in Cognitively Impaired Remitted Patients With Bipolar Disorder or Recurrent Depressive Disorder and Healthy People: Study Protocol for a Randomized, Controlled Trial",COMPLETED,,PHASE2,103.0,ACTUAL,"Mental Health Services in the Capital Region, Denmark",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 23:41:57.744149,2024-10-14 23:41:57.744149,OTHER,,,,,,,2022,0.0
NCT04742348,,2020-11-09,,,2023-02-09,2021-02-03,2021-02-08,ACTUAL,,,,,,,2023-02-09,2023-02-13,ACTUAL,2023-02,ESTIMATED,2023-02-28,2023-02,2023-02-28,2023-08,ESTIMATED,2023-08-31,2023-08,ESTIMATED,2023-08-31,,INTERVENTIONAL,,,Research on Translational Outcomes of Alcohol (Project RETRO),Research on Translational Outcomes of Alcohol (Project RETRO),WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Washington,,2.0,,COVID-19 and expiration of funding,f,,,,f,t,f,,,t,,,,,,,,2024-10-14 23:41:57.744149,2024-10-14 23:41:57.744149,OTHER,,,,,,,2023,0.0
NCT04155047,,2019-11-05,2021-03-15,,2021-04-13,2019-11-05,2019-11-07,ACTUAL,2021-03-15,2021-04-08,ACTUAL,,,,2021-04-13,2021-05-10,ACTUAL,2019-11-07,ACTUAL,2019-11-07,2021-04,2021-04-30,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,,A Clinical Study to Investigate if a Single Dose of an Approved Drug Product (Glycopyrrolate Inhalation Solution) Reduces Trapped Air in the Lungs of Participants With Chronic Obstructive Pulmonary Disease.,"A Randomized, Double-blind, Placebo-controlled, 2-Way Crossover Study of the Effect of a Single Dose of Glycopyrrolate Inhalation Solution (GIS) on Lung Hyperinflation in Subjects With Chronic Obstructive Pulmonary Disease (COPD)",COMPLETED,,PHASE4,44.0,ACTUAL,Sunovion Respiratory Development Inc.,,2.0,,,f,,,,f,t,t,,,,,,IPD will be made available upon request within 12 months of posting the study results on ct.gov.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study may be made available upon request via the Clinical Study Data Request site.,2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,INDUSTRY,,,,,,,2020,1.0
NCT04583735,,2020-10-06,2024-03-14,,2024-06-18,2020-10-06,2020-10-12,ACTUAL,2024-04-24,2024-04-26,ACTUAL,,,,2024-06-18,2024-07-01,ACTUAL,2021-09-02,ACTUAL,2021-09-02,2024-06,2024-06-30,2023-10-12,ACTUAL,2023-10-12,2023-03-17,ACTUAL,2023-03-17,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all randomized participants to receive study drug.,A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease,"A Phase 4, Randomized, Double-masked, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of TEPEZZA® in Treating Patients With Chronic (Inactive) Thyroid Eye Disease",COMPLETED,,PHASE4,62.0,ACTUAL,Amgen,,2.0,,,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,INDUSTRY,,,,,,,2023,1.0
NCT04007367,,2019-07-02,2022-08-31,2021-10-08,2023-11-27,2019-07-02,2019-07-05,ACTUAL,2022-08-31,2022-10-03,ACTUAL,2021-10-15,2021-10-20,ACTUAL,2023-11-27,2023-11-29,ACTUAL,2019-08-06,ACTUAL,2019-08-06,2023-11,2023-11-30,2020-01-06,ACTUAL,2020-01-06,2020-01-06,ACTUAL,2020-01-06,,INTERVENTIONAL,,Safety Set included all participants who were administered the study drug.,A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder,"A Phase 3, Randomized, Double-Blind, Placebo-controlled Study of the Efficacy and Safety of SAGE-217 With a Fixed, Repeated Treatment Regimen on Relapse Prevention in Adults With Major Depressive Disorder",TERMINATED,,PHASE3,53.0,ACTUAL,Biogen,The study was stopped prematurely and therefore data was not collected and analyzed for any efficacy outcome measure planned for the DB Phase of the study.,3.0,,Internal company decision,f,,,,f,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,INDUSTRY,,,,,,,2020,0.0
NCT03347526,,2017-11-15,,,2021-05-26,2017-11-17,2017-11-20,ACTUAL,,,,,,,2021-05-26,2021-05-27,ACTUAL,2018-04-19,ACTUAL,2018-04-19,2021-05,2021-05-31,2021-08,ESTIMATED,2021-08-31,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,A Novel Approach to Infantile Spasms,"A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy",SUSPENDED,,PHASE3,394.0,ESTIMATED,"University of Colorado, Denver",,3.0,,Study on enrollment hold as a precaution per the pharmaceutical company.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-14 23:41:57.744149,2024-10-14 23:41:57.744149,OTHER,,,,,,,2021,0.0
NCT04208516,,2019-12-19,2023-08-02,,2023-08-15,2019-12-19,2019-12-23,ACTUAL,2023-08-15,2023-09-13,ACTUAL,,,,2023-08-15,2023-09-13,ACTUAL,2021-05-26,ACTUAL,2021-05-26,2023-08,2023-08-31,2022-08-18,ACTUAL,2022-08-18,2022-08-18,ACTUAL,2022-08-18,,INTERVENTIONAL,,,Continuous Nerve Block Block vs Combination of Single Block Plus Intravenous Lidocaine for Postoperative Pain.,"A Prospective, Randomized, Active-Comparator, Open-Label, Non-Inferiority Study of the Efficacy of Continuous Nerve Block vs Single Block Plus Intravenous Lidocaine for Postoperative Pain.",TERMINATED,,PHASE4,17.0,ACTUAL,University of Pittsburgh,We were not able to enroll enough subjects in a timely manner and our enrollment numbers did not reach the goal of our pilot study.,2.0,,"Recruitment was unable to be obtained in a timely fashion, so the study was stopped.",f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,OTHER,,,,,,,2022,0.0
NCT03661411,,2018-09-05,,,2022-08-01,2018-09-05,2018-09-07,ACTUAL,,,,,,,2022-08-01,2022-08-03,ACTUAL,2018-10-17,ACTUAL,2018-10-17,2022-08,2022-08-31,2022-07-18,ACTUAL,2022-07-18,2022-07-18,ACTUAL,2022-07-18,,INTERVENTIONAL,ARAMIS,,Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke,"Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke: a Prospective, Random, Blinded Assessment of Outcome and Open Label Multi-center Study",COMPLETED,,PHASE4,760.0,ACTUAL,General Hospital of Shenyang Military Region,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,OTHER,,,,,,,2022,1.0
NCT03982992,,2019-06-03,,,2024-03-07,2019-06-08,2019-06-12,ACTUAL,,,,,,,2024-03-07,2024-03-12,ACTUAL,2019-06-01,ACTUAL,2019-06-01,2024-03,2024-03-31,2021-11-30,ACTUAL,2021-11-30,2021-05-31,ACTUAL,2021-05-31,,INTERVENTIONAL,DLI-TARGET,,Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab,"Phase 2 Study Evaluating the Safety, Tolerability and Efficacy of Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab in Patients With Treatment-Resistant Mixed Chimerism or Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia After Allogeneic Stem Cell Transplantation",WITHDRAWN,,PHASE2,0.0,ACTUAL,Ludwig-Maximilians - University of Munich,,1.0,,Lack of potential study subjects due to a change of standard of care treatment outside of clinical trials.,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,OTHER,,,,,,,2021,0.0
NCT01224106,,2010-10-14,2021-09-08,,2021-12-10,2010-10-18,2010-10-19,ESTIMATED,2021-12-10,2021-12-13,ACTUAL,,,,2021-12-10,2021-12-13,ACTUAL,2010-11-30,ACTUAL,2010-11-30,2021-12,2021-12-31,2020-09-10,ACTUAL,2020-09-10,2020-09-10,ACTUAL,2020-09-10,,INTERVENTIONAL,Scarlet Road,A total of 797 participants were enrolled into the Double-Blind Treatment phase of this study and the entire study. A subset (154) of these participants moved into the OLE phase of this study.,A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease,"Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease With Option for up to an Additional Two Years of Treatment and an Open-Label Extension With Active Study Treatment",COMPLETED,,PHASE3,799.0,ACTUAL,Hoffmann-La Roche,,5.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,INDUSTRY,,,,,,,2020,1.0
NCT04049175,,2019-08-05,,,2022-03-30,2019-08-06,2019-08-08,ACTUAL,,,,,,,2022-03-30,2022-04-08,ACTUAL,2019-08-28,ACTUAL,2019-08-28,2022-03,2022-03-31,2021-02-01,ACTUAL,2021-02-01,2020-10-19,ACTUAL,2020-10-19,,INTERVENTIONAL,PERSEA,,Efficacy and Safety of CHF 6532 in Patients With Uncontrolled Severe Eosinophilic Asthma,"A 52 Week, Randomised, Double Blind, Multinational, Multicentre, 4-arm Parallel Group Trial to Assess the Efficacy and Safety of 3 Doses of CHF 6532 Compared to Placebo on Top of Standard of Care in Patients With Uncontrolled Severe Eosinophilic Asthma",TERMINATED,,PHASE3,810.0,ACTUAL,Chiesi Farmaceutici S.p.A.,,4.0,,An interim analysis run by an independent data monitoring committee (DMC) to assess futility met the protocol-defined futility rules. The DMC recommended to stop the study for futility. The Sponsor issued a notification of early study termination.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,INDUSTRY,,,,,,,2021,0.0
NCT04842331,,2021-04-12,,,2024-01-10,2021-04-12,2021-04-13,ACTUAL,,,,,,,2024-01-10,2024-01-12,ACTUAL,2021-09,ESTIMATED,2021-09-30,2024-01,2024-01-31,2022-01,ESTIMATED,2022-01-31,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,PREVENT,,PREvent Viral Exposure and Transmission Study: a COVID-19 (SARS-CoV-2) PEP Study (PREVENT),"A Randomised Multicentre Post-exposure Prophylaxis Clinical Trial Evaluating RESP301, an Inhaled Therapy for Treatment of Lung Infections, for Prevention of Onward Transmission of Viral Infections Including SARS-CoV-2 to Household Members",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Thirty Respiratory Limited,,2.0,,"A combination of factors, including the dynamic nature of the COVID-19 pandemic and the successful vaccination program, has resulted in a very sharp decline in the number of patients with COVID-19",f,,,,t,f,f,,,f,,,,,,,,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,INDUSTRY,,,,,,,2022,0.0
NCT03661138,,2018-09-05,,,2023-02-27,2018-09-05,2018-09-07,ACTUAL,,,,,,,2023-02-27,2023-03-01,ACTUAL,2018-10-27,ACTUAL,2018-10-27,2023-02,2023-02-28,2022-08-19,ACTUAL,2022-08-19,2022-08-19,ACTUAL,2022-08-19,,INTERVENTIONAL,Rising Up,,A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis,"A Phase 3 Randomized, Multicenter, Double-Blind Study to Evaluate the Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects in Japan With Moderate to Severe Atopic Dermatitis",COMPLETED,,PHASE3,272.0,ACTUAL,AbbVie,,4.0,,,f,,,,t,f,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,INDUSTRY,,,,,,,2022,1.0
NCT04109092,,2019-08-27,,,2020-12-10,2019-09-27,2019-09-30,ACTUAL,,,,,,,2020-12-10,2020-12-14,ACTUAL,2020-02-13,ACTUAL,2020-02-13,2020-07,2020-07-31,2022-09-29,ESTIMATED,2022-09-29,2022-09-29,ESTIMATED,2022-09-29,,INTERVENTIONAL,,,"A Study of Stimulator of Interferon Genes (STING) Agonist E7766 in Non-muscle Invasive Bladder Cancer (NMIBC) Including Participants Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy, INPUT-102","INtravesical Phase 1/1b Study of STING Agonist E7766 in NMIBC Including Subjects Unresponsive to BCG Therapy, INPUT-102",WITHDRAWN,,PHASE1,0.0,ACTUAL,Eisai Inc.,,3.0,,"There was no enrolment of participants.Unscheduled Clinical Study Closure - Eisai Network Company Decision, November 12, 2020.",f,,,,f,t,f,,,,,,,,,YES,Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,INDUSTRY,,,,,,,2022,0.0
NCT04810689,,2021-03-17,,,2022-06-20,2021-03-19,2021-03-23,ACTUAL,,,,,,,2022-06-20,2022-06-27,ACTUAL,2021-03-01,ACTUAL,2021-03-01,2022-06,2022-06-30,2022-06-20,ACTUAL,2022-06-20,2022-06-20,ACTUAL,2022-06-20,,INTERVENTIONAL,,,"Pilot Trial of XFBD, a TCM, in Persons With COVID-19","A Randomized, Double-Blind, Placebo-Control Pilot Trial of Xuanfei Baidu Granules (XFBD), a Traditional Chinese Medicine (TCM), in Persons With COVID-19",TERMINATED,,PHASE2,5.0,ACTUAL,University of Southern California,,2.0,,Futile Enrollment,f,,,,t,t,f,,,,,,,,,,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,OTHER,,,,,,,2022,0.0
NCT03708354,,2018-10-10,,,2022-02-02,2018-10-12,2018-10-17,ACTUAL,,,,,,,2022-02-02,2022-02-18,ACTUAL,2019-04-15,ACTUAL,2019-04-15,2022-02,2022-02-28,2022-12-31,ESTIMATED,2022-12-31,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,VitE-muscle,,Tocotrienols for Skeletal Muscle Health,Tocotrienols Supplementation for Postmenopausal Women With Low Muscle Strength,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Texas Tech University Health Sciences Center,,2.0,,Difficulties in Recruiting,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,OTHER,,,,,,,2022,0.0
NCT03746587,,2018-11-01,,,2023-01-10,2018-11-16,2018-11-19,ACTUAL,,,,,,,2023-01-10,2023-01-11,ACTUAL,2018-06-06,ACTUAL,2018-06-06,2023-01,2023-01-31,2021-10-15,ACTUAL,2021-10-15,2020-04-01,ACTUAL,2020-04-01,,INTERVENTIONAL,,,Study of Arimoclomol in Patients Diagnosed With Gaucher Disease Type 1 or 3,"Multicentre Double-blinded, Randomized Placebo-controlled Study of Arimoclomol in Patients Diagnosed With Gaucher Disease Type 1 or 3",TERMINATED,,PHASE2,39.0,ACTUAL,ZevraDenmark,,4.0,,COVID-19 pandemic made it impossible to assess the trial objective,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,INDUSTRY,,,,,,,2021,0.0
NCT04406948,,2020-05-17,,,2024-05-30,2020-05-24,2020-05-29,ACTUAL,,,,,,,2024-05-30,2024-06-03,ACTUAL,2024-05-30,ACTUAL,2024-05-30,2024-05,2024-05-31,2024-05-30,ACTUAL,2024-05-30,2024-05-30,ACTUAL,2024-05-30,,INTERVENTIONAL,,,Study of Safety and Efficacy of MGCND00EP1 as an Add on Treatment in Children and Adolescents With Resistant Epilepsies,"Randomized, Double Blind, Placebo Controlled, Parallel Design Phase II b Study of Safety and Efficacy of MGCND00EP1 as an Add on Treatment in Children and Adolescents With Resistant Epilepsies",WITHDRAWN,,PHASE2,0.0,ACTUAL,MGC Pharmaceuticals d.o.o,,2.0,,Failure to overcome bureaucratic obstacles within timeframe.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,INDUSTRY,,,,,,,2024,0.0
NCT05229068,,2022-01-27,,,2022-03-31,2022-01-27,2022-02-08,ACTUAL,,,,,,,2022-03-31,2022-04-07,ACTUAL,2022-03-11,ESTIMATED,2022-03-11,2022-03,2022-03-31,2024-10-24,ESTIMATED,2024-10-24,2023-11-06,ESTIMATED,2023-11-06,,INTERVENTIONAL,,,"A Study of Safety, Reactogenicity and Immune Response of the Repeat Vaccination Against RSV When Given to Female Participants of 18-49 Years of Age During Their Subsequent Uncomplicated Pregnancy","A Phase IIIB, Open Label, Non-randomized, Controlled, Multi-country Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Repeat Vaccination With 120 µg Dose of RSV Maternal Vaccine During Subsequent Pregnancy in Healthy Maternal Participants 18-49 Years of Age",WITHDRAWN,,PHASE3,0.0,ACTUAL,GlaxoSmithKline,,2.0,,"Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in this study.",f,,,,t,t,f,,,f,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,INDUSTRY,,,,,,,2024,0.0
NCT03241641,,2017-08-03,,,2021-03-25,2017-08-03,2017-08-07,ACTUAL,,,,,,,2021-03-25,2021-03-29,ACTUAL,2017-10-26,ACTUAL,2017-10-26,2021-03,2021-03-31,2021-03-25,ACTUAL,2021-03-25,2021-03-25,ACTUAL,2021-03-25,,INTERVENTIONAL,,,Switching From TDF to TAF vs. Maintaining TDF in Chronic Hepatitis B With Resistance to Adefovir or Entecavir.,Switching From Tenofovir Disoproxil Fumarate(TDF) to Tenofovir AlaFenamide(TAF) vs. Maintaining TDF Monotherapy in Chronic Hepatitis B Patients With Genotypic Resistance to Adefovir or Entecavir,COMPLETED,,PHASE4,174.0,ACTUAL,Asan Medical Center,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,OTHER,,,,,,,2021,1.0
NCT03351608,,2017-11-20,2021-01-13,,2021-01-13,2017-11-20,2017-11-24,ACTUAL,2021-01-13,2021-02-05,ACTUAL,,,,2021-01-13,2021-02-05,ACTUAL,2018-02-12,ACTUAL,2018-02-12,2021-01,2021-01-31,2020-01-28,ACTUAL,2020-01-28,2020-01-28,ACTUAL,2020-01-28,,INTERVENTIONAL,,,"Efficacy, Safety, and Pharmacokinetics of Sugammadex for Reversal of Neuromuscular Blockade (NMB) in Pediatric Participants (MK-8616-089)","A Phase 4 Double-Blinded, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants",COMPLETED,,PHASE4,288.0,ACTUAL,Merck Sharp & Dohme LLC,,5.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,INDUSTRY,,,,,,,2020,1.0
NCT04512066,,2020-08-12,2023-06-16,,2023-09-15,2020-08-12,2020-08-13,ACTUAL,2023-09-15,2023-10-10,ACTUAL,,,,2023-09-15,2023-10-10,ACTUAL,2020-09-08,ACTUAL,2020-09-08,2023-09,2023-09-30,2022-06-21,ACTUAL,2022-06-21,2022-06-21,ACTUAL,2022-06-21,,INTERVENTIONAL,,The efficacy analysis population (EAP) was used to determine baseline characteristics. The EAP included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline.,A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder,"A Phase II, Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder",COMPLETED,,PHASE2,287.0,ACTUAL,Hoffmann-La Roche,,4.0,,,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,INDUSTRY,,,,,,,2022,1.0
NCT04115748,,2019-10-02,2022-01-18,,2022-04-21,2019-10-02,2019-10-04,ACTUAL,2022-04-21,2022-05-16,ACTUAL,,,,2022-04-21,2022-05-16,ACTUAL,2019-12-03,ACTUAL,2019-12-03,2022-04,2022-04-30,2021-05-11,ACTUAL,2021-05-11,2021-01-19,ACTUAL,2021-01-19,,INTERVENTIONAL,PENGUIN 1,Safety Analysis Set included all participants who received at least 1 dose of study drug.,Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy,"A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy",TERMINATED,,PHASE3,67.0,ACTUAL,Gilead Sciences,"Due to early termination of the study and insufficient number of participants enrolled, all the hypothesis testing performed and the p values reported were nominal. Therefore, the results need to be interpreted with caution.",6.0,,Development program terminated,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:41:57.744149,2024-10-14 23:41:57.744149,INDUSTRY,,,,,,,2021,0.0
NCT04211831,,2019-12-23,2023-03-29,2022-07-22,2023-03-29,2019-12-23,2019-12-26,ACTUAL,2023-03-29,2023-04-20,ACTUAL,2022-07-22,2022-07-27,ACTUAL,2023-03-29,2023-04-20,ACTUAL,2019-12-16,ACTUAL,2019-12-16,2023-03,2023-03-31,2022-07-20,ACTUAL,2022-07-20,2021-11-18,ACTUAL,2021-11-18,,INTERVENTIONAL,,Intent- to-treat Exposed (ITT-E) population was defined as all participants who were randomized and treated.,URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence,An Exploratory Phase 2a Study Evaluating the Efficacy and Safety of URO-902 in Subjects With Overactive Bladder and Urge Urinary Incontinence,COMPLETED,,PHASE2,80.0,ACTUAL,Urovant Sciences GmbH,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,INDUSTRY,,,,,,,2022,1.0
NCT04785547,,2021-03-01,,,2024-01-11,2021-03-04,2021-03-08,ACTUAL,,,,,,,2024-01-11,2024-01-16,ACTUAL,2020-12-17,ACTUAL,2020-12-17,2024-01,2024-01-31,2022-01-22,ACTUAL,2022-01-22,2022-01-22,ACTUAL,2022-01-22,,INTERVENTIONAL,,,ALL SCTped 2012 FORUM Add-on Study Blina Post HSCT,A Phase II Study of Blincyto in Children With CD19+ Precursor B-lineage ALL and MRD-Positivity Before and/or Following First Allogeneic HSCT,TERMINATED,,PHASE2,3.0,ACTUAL,St. Anna Kinderkrebsforschung,,1.0,,Terminated by Amgen Limited,f,,,,,t,f,,,t,,,,,,,,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,OTHER,,,,,,,2022,0.0
NCT04493333,,2020-07-27,2024-07-12,,2024-09-16,2020-07-29,2020-07-30,ACTUAL,2024-09-16,2024-09-23,ACTUAL,,,,2024-09-16,2024-09-23,ACTUAL,2021-06-07,ACTUAL,2021-06-07,2024-09,2024-09-30,2023-07-18,ACTUAL,2023-07-18,2023-07-18,ACTUAL,2023-07-18,,INTERVENTIONAL,,Postmenopausal females between 18 and 70 with a history of breast cancer.,Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors,Comparison of Vaginal Dehydroepiandrosterone (DHEA) to Control for Treatment of Vaginal Symptoms in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors: A Phase II Randomized Trial,TERMINATED,,PHASE2,8.0,ACTUAL,University of Arkansas,Early termination due to low enrollment and lack of subject participation/noncompliance.,2.0,,Low recruitment/enrollment,f,,,,f,t,f,,,,,,,,,,,2024-10-14 23:41:57.744149,2024-10-14 23:41:57.744149,OTHER,,,,,,,2023,0.0
NCT03258723,,2017-08-20,2022-12-01,,2024-02-01,2017-08-20,2017-08-23,ACTUAL,2022-12-01,2022-12-22,ACTUAL,,,,2024-02-01,2024-02-06,ACTUAL,2018-07-30,ACTUAL,2018-07-30,2024-02,2024-02-29,2021-12-01,ACTUAL,2021-12-01,2021-12-01,ACTUAL,2021-12-01,,INTERVENTIONAL,LIME,,Diabetes Prevention With Lifestyle Intervention and Metformin Escalation,Diabetes Prevention With Lifestyle Intervention and Metformin Escalation,TERMINATED,,PHASE4,114.0,ACTUAL,Yale University,,2.0,,COVID-19 led to changes in study design and an early end to data collection.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,OTHER,,,,,,,2021,0.0
NCT03905343,,2019-03-12,,,2021-06-11,2019-04-04,2019-04-05,ACTUAL,,,,,,,2021-06-11,2021-06-16,ACTUAL,2019-06-25,ACTUAL,2019-06-25,2021-06,2021-06-30,2021-04-15,ACTUAL,2021-04-15,2021-04-15,ACTUAL,2021-04-15,,INTERVENTIONAL,,,Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line in Visceral mBC,"Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line Treatment in Patients With Visceral Metastatic Breast Cancer. A Multicenter, Randomized Phase III Trial.",TERMINATED,,PHASE3,25.0,ACTUAL,Swiss Group for Clinical Cancer Research,,2.0,,Feasibility (low patient accrual and financial reasons),f,,,,t,f,f,,,,,,,,,,,2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,OTHER,,,,,,,2021,0.0
NCT04143945,,2019-10-28,2020-12-23,,2020-12-23,2019-10-28,2019-10-30,ACTUAL,2020-12-23,2021-01-20,ACTUAL,,,,2020-12-23,2021-01-20,ACTUAL,2019-10-28,ACTUAL,2019-10-28,2020-12,2020-12-31,2020-01-04,ACTUAL,2020-01-04,2020-01-04,ACTUAL,2020-01-04,,INTERVENTIONAL,,The full analysis set included all participants who had received at least 1 injection of semaglutide (included any skin contact with trial product whether the injection was completed or not).,"A Study Comparing the Injection Site Pain Experience After the Injection of Semaglutide B and Semaglutide D With 2 Different Injection Pens, a Compound for the Treatment of Type 2 Diabetes and Obesity",A Trial to Compare the Injection Site Pain Experience of 0.25 mg Semaglutide B and Semaglutide D Administered sc,COMPLETED,,PHASE2,104.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,f,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,INDUSTRY,,,,,,,2020,1.0
NCT05310071,,2022-03-25,,,2024-08-28,2022-03-25,2022-04-04,ACTUAL,,,,,,,2024-08-28,2024-08-30,ACTUAL,2022-06-02,ACTUAL,2022-06-02,2024-08,2024-08-31,2024-08-12,ACTUAL,2024-08-12,2024-08-12,ACTUAL,2024-08-12,,INTERVENTIONAL,ENVISION,,A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease,"A Phase 3b/4 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants With Alzheimer's Disease",TERMINATED,,PHASE3,1027.0,ACTUAL,Biogen,,2.0,,Sponsor's Decision,f,,,,t,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,INDUSTRY,,,,,,,2024,0.0
NCT04225676,,2020-01-09,2022-04-14,,2023-01-27,2020-01-09,2020-01-13,ACTUAL,2022-07-08,2022-07-15,ACTUAL,,,,2023-01-27,2023-01-30,ACTUAL,2020-10-19,ACTUAL,2020-10-19,2023-01,2023-01-31,2021-10-19,ACTUAL,2021-10-19,2021-10-19,ACTUAL,2021-10-19,,INTERVENTIONAL,,,Study of Efficacy and Safety of Reinfusion of Tisagenlecleucel in Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia (ALL),"A Phase II, Open Label, Multi-center Trial to Determine the Efficacy and Safety of Tisagenlecleucel Re-infusion in Pediatric and Adolescent Young Adult (AYA) Patients With Acute Lymphoblastic Leukemia Experiencing Loss of B Cell Aplasia",TERMINATED,,PHASE2,5.0,ACTUAL,Novartis,,1.0,,Terminated due to slow enrollment,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.",2024-10-14 23:41:57.744149,2024-10-14 23:41:57.744149,INDUSTRY,,,,,,,2021,0.0
NCT04729595,,2021-01-25,,,2022-12-05,2021-01-26,2021-01-28,ACTUAL,,,,,,,2022-12-05,2022-12-06,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2022-12,2022-12-31,2022-09-21,ACTUAL,2022-09-21,2022-09-21,ACTUAL,2022-09-21,,INTERVENTIONAL,,,Study to Evaluate the Effects of Tempol (MBM-02) in COVID-19 Patients.,"A Phase 2/3, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Tempol (MBM-02) in Subjects With COVID-19 Infection",TERMINATED,,PHASE2/PHASE3,248.0,ACTUAL,Adamis Pharmaceuticals Corporation,,2.0,,Study did not demonstrate statistical significance of its primary endpoint of clinical resolution of COVID-19 symptoms at day 14 versus placebo,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,INDUSTRY,,,,,,,2022,0.0
NCT04790903,,2021-03-08,,,2024-07-09,2021-03-08,2021-03-10,ACTUAL,,,,,,,2024-07-09,2024-07-11,ACTUAL,2021-07-02,ACTUAL,2021-07-02,2024-07,2024-07-31,2024-05-21,ACTUAL,2024-05-21,2024-05-21,ACTUAL,2024-05-21,,INTERVENTIONAL,,,"A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Participants With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma (DLBCL)","A Phase Ib Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Patients With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma",TERMINATED,,PHASE1,50.0,ACTUAL,Hoffmann-La Roche,,2.0,,Decision to discontinue the study based on broader development and strategic prioritisation. The Sponsor concludes there is no benefit-risk impact on the BO42203 study.,f,,,,,t,f,,,,,,,,,NO,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,INDUSTRY,,,,,,,2024,0.0
NCT03860844,,2019-02-21,2023-09-07,,2024-04-22,2019-02-28,2019-03-04,ACTUAL,2023-10-25,2023-11-15,ACTUAL,,,,2024-04-22,2024-05-16,ACTUAL,2019-08-06,ACTUAL,2019-08-06,2024-04,2024-04-30,2023-05-26,ACTUAL,2023-05-26,2022-09-12,ACTUAL,2022-09-12,,INTERVENTIONAL,ISAKIDS,The All-treated (AT) population consisted of all participants who received at least 1 dose (even incomplete) of study treatment.,Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia,"Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse",TERMINATED,,PHASE2,67.0,ACTUAL,Sanofi,The study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met) and not due to safety concerns.,1.0,,Study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met); not due to safety concerns.,f,,,,t,t,f,,,f,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,INDUSTRY,,,,,,,2023,0.0
NCT04020341,,2019-07-11,2023-05-29,,2023-05-29,2019-07-11,2019-07-16,ACTUAL,2023-05-29,2023-06-22,ACTUAL,,,,2023-05-29,2023-06-22,ACTUAL,2019-10-17,ACTUAL,2019-10-17,2023-05,2023-05-31,2022-11-30,ACTUAL,2022-11-30,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,,Participants randomly assigned to the study treatment were included in the ITT population.,A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI),"A Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of Gepotidacin to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)",COMPLETED,,PHASE3,1531.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,INDUSTRY,,,,,,,2022,1.0
NCT03843853,,2019-02-14,,,2022-07-20,2019-02-14,2019-02-18,ACTUAL,,,,,,,2022-07-20,2022-07-25,ACTUAL,2019-05-01,ESTIMATED,2019-05-01,2022-07,2022-07-31,2022-05-01,ESTIMATED,2022-05-01,2021-11-01,ESTIMATED,2021-11-01,,INTERVENTIONAL,,,Pemetrexed and S-1 in Combination With Bevacizumab in Refractory Colorectal Cancer,"A Single Arm, Open Label, Exploratory Study of Pemetrexed and S-1 in Combination With Bevacizumab in Patients Who Have Progressed After Standard Second Line Therapy",WITHDRAWN,,PHASE2,0.0,ACTUAL,The First Affiliated Hospital with Nanjing Medical University,,1.0,,cooperation terminated,f,,,,,t,f,,,t,,,,,,NO,,2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,OTHER,,,,,,,2022,0.0
NCT05627791,,2022-11-09,,,2023-08-28,2022-11-25,2022-11-28,ACTUAL,,,,,,,2023-08-28,2023-08-31,ACTUAL,2022-11-30,ACTUAL,2022-11-30,2023-08,2023-08-31,2023-08-28,ACTUAL,2023-08-28,2023-07-31,ACTUAL,2023-07-31,,INTERVENTIONAL,,,Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman,Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman: A Randomized Placebo-controlled Trial,TERMINATED,,PHASE2/PHASE3,6.0,ACTUAL,Rajavithi Hospital,,2.0,,Unable to recuit participant number in time.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,OTHER_GOV,,,,,,,2023,0.0
NCT03772587,,2018-12-10,2021-06-22,,2023-06-06,2018-12-10,2018-12-11,ACTUAL,2021-09-28,2021-10-27,ACTUAL,,,,2023-06-06,2023-06-27,ACTUAL,2019-04-10,ACTUAL,2019-04-10,2023-05,2023-05-31,2020-06-25,ACTUAL,2020-06-25,2020-06-25,ACTUAL,2020-06-25,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all randomized participants.,"A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis","A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis",COMPLETED,,PHASE2,68.0,ACTUAL,"Momenta Pharmaceuticals, Inc.","Limitations to this study include the small sample sizes of each treatment arm and the study activity disruption due to the COVID-19 pandemic, especially the missed Quantitative Myasthenia Gravis (QMG) assessments which hampered the analysis of the endpoint.",5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,INDUSTRY,,,,,,,2020,1.0
NCT03983980,,2019-06-10,2022-06-21,2020-10-07,2022-09-16,2019-06-10,2019-06-12,ACTUAL,2022-09-16,2022-10-13,ACTUAL,2022-09-16,2022-10-13,ACTUAL,2022-09-16,2022-10-13,ACTUAL,2019-06-06,ACTUAL,2019-06-06,2022-09,2022-09-30,2020-05-29,ACTUAL,2020-05-29,2020-05-13,ACTUAL,2020-05-13,,INTERVENTIONAL,,,Tapinarof for the Treatment of Plaque Psoriasis in Adults (3002),A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Plaque Psoriasis in Adults,COMPLETED,,PHASE3,515.0,ACTUAL,"Dermavant Sciences, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,INDUSTRY,,,,,,,2020,1.0
NCT04841577,,2021-04-08,2022-09-20,,2024-08-14,2021-04-08,2021-04-12,ACTUAL,2022-09-20,2022-10-18,ACTUAL,,,,2024-08-14,2024-09-03,ACTUAL,2021-04-27,ACTUAL,2021-04-27,2024-08,2024-08-31,2022-02-08,ACTUAL,2022-02-08,2021-09-22,ACTUAL,2021-09-22,,INTERVENTIONAL,,,A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 60 Years and Above,"A Phase 3, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU-QIV Vaccine in Adults Aged 60 Years and Above",COMPLETED,,PHASE3,976.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,f,t,f,,,f,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf,YES,"GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf",2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,INDUSTRY,,,,,,,2022,1.0
NCT03817190,,2019-01-23,2022-02-02,,2022-11-03,2019-01-23,2019-01-25,ACTUAL,2022-05-05,2022-05-06,ACTUAL,,,,2022-11-03,2022-11-28,ACTUAL,2019-09-19,ACTUAL,2019-09-19,2022-09,2022-09-30,2020-09-03,ACTUAL,2020-09-03,2020-09-03,ACTUAL,2020-09-03,,INTERVENTIONAL,,The Randomised Set consists of all patients who are randomised to the study.,Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis,"A Randomised, Double-blind, Placebo-controlled, Study to Assess the Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis",TERMINATED,,PHASE2,219.0,ACTUAL,DS Biopharma,The decision to terminate the study prematurely was based on the results from an interim analysis.,2.0,,Based on Interim Analysis results,f,,,,f,t,f,,,,,,,,,,,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,INDUSTRY,,,,,,,2020,0.0
NCT04992065,,2021-07-28,,2023-04-26,2024-02-15,2021-07-28,2021-08-05,ACTUAL,,,,,2023-05-01,ACTUAL,2024-02-15,2024-02-16,ACTUAL,2021-08-03,ACTUAL,2021-08-03,2024-02,2024-02-29,2022-06-20,ACTUAL,2022-06-20,2022-04-26,ACTUAL,2022-04-26,,INTERVENTIONAL,,,A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease,"Dose Response and Safety of an Oral PCSK9i, NNC0385-0434, in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD Risk on Maximally Tolerated Statin Dose and Other Lipid-lowering Therapy Requiring Further LDL-C Reduction",COMPLETED,,PHASE2,255.0,ACTUAL,Novo Nordisk A/S,,7.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-14 23:41:57.744149,2024-10-14 23:41:57.744149,INDUSTRY,,,,,,,2022,1.0
NCT02601014,,2015-08-21,2021-11-16,,2022-01-06,2015-11-06,2015-11-10,ESTIMATED,2022-01-06,2022-02-03,ACTUAL,,,,2022-01-06,2022-02-03,ACTUAL,2016-03-15,ACTUAL,2016-03-15,2022-01,2022-01-31,2021-10-06,ACTUAL,2021-10-06,2020-12-03,ACTUAL,2020-12-03,,INTERVENTIONAL,STARVE-PC,,Biomarker-Driven Therapy With Nivolumab and Ipilimumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Expressing AR-V7,Biomarker-Driven Phase-2 Study of Combined Immune Checkpoint Blockade for AR-V7-Expressing Metastatic Castration-Resistant Prostate Cancer (STARVE-PC),COMPLETED,,PHASE2,32.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,OTHER,,,,,,,2021,0.0
NCT05418101,,2022-06-03,,,2024-04-22,2022-06-09,2022-06-14,ACTUAL,,,,,,,2024-04-22,2024-04-24,ACTUAL,2022-04-28,ACTUAL,2022-04-28,2024-04,2024-04-30,2024-02-15,ACTUAL,2024-02-15,2024-02-15,ACTUAL,2024-02-15,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, PK and PD of VIS171 in Participants (Healthy and With Autoimmune Disease)","A Phase 1, First-in-human, 2-part Study (Part 1 is a Single Ascending Dose in Healthy Participants; Part 2 is a Multiple Ascending Dose Study in Participants With Autoimmune Disease) to Evaluate the Safety, PD and PK of VIS171",TERMINATED,,PHASE1,61.0,ACTUAL,"Visterra, Inc.",,8.0,,The study terminated due to internal strategy change due to changes in risk-benefit ratio,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,INDUSTRY,,,,,,,2024,0.0
NCT03654040,,2018-08-28,2024-02-02,,2024-04-22,2018-08-28,2018-08-31,ACTUAL,2024-04-22,2024-04-23,ACTUAL,,,,2024-04-22,2024-04-23,ACTUAL,2021-04-22,ACTUAL,2021-04-22,2024-04,2024-04-30,2023-03-06,ACTUAL,2023-03-06,2023-03-06,ACTUAL,2023-03-06,,INTERVENTIONAL,LITTMUS-UCSF,Transplanted participants who enrolled but did not receive arTregs and living donors of the prospective transplant recipient who consented and enrolled into the study,Liver Transplantation With Tregs at UCSF,A Phase I/II Drug Withdrawal Study of Alloantigen-Specific Tregs in Liver Transplantation,TERMINATED,,PHASE1/PHASE2,42.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),"The study was terminated by the sponsor in February 2023 prior to any participant receiving the investigational product, arTregs. The study's low enrollment would not allow for study completion within the necessary timeframe.",1.0,,The study was terminated by the Sponsor prior to any participants receiving the investigational product.,f,,,,t,t,f,,,,,,The aim is to share data available to the public within 24 months upon completion of the study.,ImmPort public data access.,http://www.immport.org/immport-open/public/home/home,YES,"The plan is to share data upon completion of the study in ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.",2024-10-14 23:41:57.744149,2024-10-14 23:41:57.744149,NIH,,,,,,,2023,0.0
NCT01564537,,2012-03-22,2015-12-19,,2023-02-07,2012-03-27,2012-03-28,ESTIMATED,2015-12-19,2016-01-27,ESTIMATED,,,,2023-02-07,2023-03-10,ACTUAL,2012-08-01,ACTUAL,2012-08-01,2023-02,2023-02-28,2022-02-08,ACTUAL,2022-02-08,2014-10-01,ACTUAL,2014-10-01,,INTERVENTIONAL,,Intent-to-Treat (ITT) population was defined as all randomized participants.,A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma,"A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral Ixazomib (MLN9708) Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma",COMPLETED,,PHASE3,722.0,ACTUAL,Takeda,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,INDUSTRY,,,,,,,2022,1.0
NCT03575208,,2018-06-29,,,2022-04-04,2018-06-29,2018-07-02,ACTUAL,,,,,,,2022-04-04,2022-04-06,ACTUAL,2019-02-13,ACTUAL,2019-02-13,2022-04,2022-04-30,2022-03-29,ACTUAL,2022-03-29,2022-03-29,ACTUAL,2022-03-29,,INTERVENTIONAL,,,Hepatitis B Immune Globulin (HBIg) to Restore Immune Control in People With Chronic Hepatitis B,Use of Hepatitis B Immune Globulin (HBIg) to Restore Immune Control in Patients With Chronic Hepatitis B,WITHDRAWN,,PHASE2,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,Slow/Insufficient accrual,f,,,,,t,f,,,,,,,,,,,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,NIH,,,,,,,2022,0.0
NCT04768855,,2021-02-23,,,2022-06-17,2021-02-23,2021-02-24,ACTUAL,,,,,,,2022-06-17,2022-06-21,ACTUAL,2021-03-17,ACTUAL,2021-03-17,2022-06-09,2022-06-09,2022-05-30,ACTUAL,2022-05-30,2022-05-30,ACTUAL,2022-05-30,,INTERVENTIONAL,,,A Study of LY3540378 in Healthy Participants,"A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3540378 in Healthy Participants",COMPLETED,,PHASE1,134.0,ACTUAL,Eli Lilly and Company,,5.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,INDUSTRY,,,,,,,2022,1.0
NCT04109144,,2019-09-25,,,2022-08-22,2019-09-27,2019-09-30,ACTUAL,,,,,,,2022-08-22,2022-08-25,ACTUAL,2019-11-11,ACTUAL,2019-11-11,2022-08,2022-08-31,2023-07,ESTIMATED,2023-07-31,2023-07,ESTIMATED,2023-07-31,,INTERVENTIONAL,,,Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis,Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis,WITHDRAWN,,PHASE2,0.0,ACTUAL,Montefiore Medical Center,,2.0,,"PI confirmed that while coordination and planning was conducted upon IRB approval, no participants were enrolled into the study",f,,,,f,t,f,,,t,,,,,,NO,Data collected during the study will only be shared with researchers that have been IRB approved as key-personnel on the study protocol.,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,OTHER,,,,,,,2023,0.0
NCT04216784,,2019-12-23,,,2024-05-07,2020-01-02,2020-01-03,ACTUAL,,,,,,,2024-05-07,2024-05-09,ACTUAL,2019-12-19,ACTUAL,2019-12-19,2024-05,2024-05-31,2024-04-01,ACTUAL,2024-04-01,2023-12-30,ACTUAL,2023-12-30,,INTERVENTIONAL,,,Comparison of Diuretic Effect With Furosemide Alone Versus the Combination of Furosemide and Albumin in Cirrhotic Patients,Comparison of Diuretic Effect With Furosemide Alone Versus the Combination of Furosemide and Albumin in Cirrhotic Patients,TERMINATED,,PHASE4,21.0,ACTUAL,Rush University Medical Center,,2.0,,The study halted prematurely due to staffing.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-14 23:41:57.744149,2024-10-14 23:41:57.744149,OTHER,,,,,,,2024,0.0
NCT04540419,,2020-08-17,,,2024-04-22,2020-09-04,2020-09-07,ACTUAL,,,,,,,2024-04-22,2024-04-23,ACTUAL,2020-09-11,ACTUAL,2020-09-11,2024-04,2024-04-30,2021-07-30,ACTUAL,2021-07-30,2021-06-19,ACTUAL,2021-06-19,,INTERVENTIONAL,,,Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Against COVID-19,"Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group Study Evaluating Efficacy, Reactogenicity and Safety of Recombinant Vaccine Ad5-nCoV Against Novel Coronavirus Infection in Adult Volunteers",COMPLETED,,PHASE3,500.0,ACTUAL,NPO Petrovax,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,INDUSTRY,,,,,,,2021,1.0
NCT05172115,,2021-12-10,,,2021-12-28,2021-12-28,2021-12-29,ACTUAL,,,,,,,2021-12-28,2021-12-29,ACTUAL,2018-12-22,ACTUAL,2018-12-22,2021-12,2021-12-31,2020-05-02,ACTUAL,2020-05-02,2020-02-02,ACTUAL,2020-02-02,,INTERVENTIONAL,CANARY,,Catheter-Directed Thrombolysis Versus Anticoagulation Monotherapy in Intermediate-High Risk PE,Catheter-Directed Thrombolysis Versus ANticoagulation Monotherapy in Patients With Acute Intermediate-High Risk PulmonarY Embolism: The CANARY Randomized Clinical Trial,TERMINATED,,PHASE3,94.0,ACTUAL,Rajaie Cardiovascular Medical and Research Center,,2.0,,Due to the COVID-19 pandemic,f,,,,t,f,f,,,,,,,,,NO,"Data will become available to interested investigators upon submitting a reasonable research request, approved by the Steering Committee of the trial.",2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,OTHER,,,,,,,2020,0.0
NCT03571828,,2018-06-18,2022-10-24,,2023-09-22,2018-06-18,2018-06-28,ACTUAL,2023-09-22,2024-03-22,ACTUAL,,,,2023-09-22,2024-03-22,ACTUAL,2018-10-29,ACTUAL,2018-10-29,2023-09,2023-09-30,2022-01-12,ACTUAL,2022-01-12,2022-01-12,ACTUAL,2022-01-12,,INTERVENTIONAL,,Safety Analysis Set: All participants who received at least one dose of investigational product.,"Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With r/r Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma","A Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With Relapsed / Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma",TERMINATED,,PHASE1,10.0,ACTUAL,Amgen,Amgen decided not to continue development of AMG 562 because of a business decision and not because of safety reasons. No conclusions can be drawn due to the small sample size of this study.,2.0,,Amgen decided to discontinue study because of a business decision and not because of safety reasons,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,INDUSTRY,,,,,,,2022,0.0
NCT01609790,,2012-05-30,2016-10-25,,2022-06-28,2012-05-30,2012-06-01,ESTIMATED,2017-01-09,2017-02-27,ACTUAL,,,,2022-06-28,2022-07-21,ACTUAL,2012-06-04,ACTUAL,2012-06-04,2022-05,2022-05-31,2022-05-20,ACTUAL,2022-05-20,2015-10-02,ACTUAL,2015-10-02,,INTERVENTIONAL,,All eligible patients.,Bevacizumab With or Without Trebananib in Treating Patients With Recurrent Brain Tumors,Phase II Double-Blinded Placebo-Controlled Study of Bevacizumab With or Without AMG 386 in Patients With Recurrent Glioblastoma or Gliosarcoma,COMPLETED,,PHASE2,137.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,NIH,,,,,,,2022,1.0
NCT03846427,,2018-10-11,2022-01-14,,2023-06-02,2019-02-15,2019-02-19,ACTUAL,2022-02-09,2022-03-03,ACTUAL,,,,2023-06-02,2023-06-06,ACTUAL,2019-02-19,ACTUAL,2019-02-19,2023-06,2023-06-30,2022-05-04,ACTUAL,2022-05-04,2022-05-04,ACTUAL,2022-05-04,,INTERVENTIONAL,MAGNOLIA,,Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma,"A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients With Relapsed or Refractory Marginal Zone Lymphoma",COMPLETED,,PHASE2,68.0,ACTUAL,BeiGene,,1.0,,,f,,,,f,t,f,,,,,,,,,YES,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,INDUSTRY,,,,,,,2022,1.0
NCT01578239,,2012-04-10,2017-08-29,,2022-03-10,2012-04-13,2012-04-16,ESTIMATED,2017-08-29,2017-10-02,ACTUAL,,,,2022-03-10,2022-04-04,ACTUAL,2012-09-06,ACTUAL,2012-09-06,2022-02,2022-02-28,2021-01-18,ACTUAL,2021-01-18,2015-07-31,ACTUAL,2015-07-31,,INTERVENTIONAL,NETTER-1,,"A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours","A Multicentre, Stratified, Open, Randomized, Comparator-controlled, Parallel-group Phase III Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours",COMPLETED,,PHASE3,231.0,ACTUAL,Advanced Accelerator Applications,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,INDUSTRY,,,,,,,2021,1.0
NCT04273191,,2020-02-14,,,2020-08-14,2020-02-14,2020-02-18,ACTUAL,,,,,,,2020-08-14,2020-08-18,ACTUAL,2020-02,ESTIMATED,2020-02-29,2020-08,2020-08-31,2021-08,ESTIMATED,2021-08-31,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,,,A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone),An Evaluation of Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO,WITHDRAWN,,PHASE4,0.0,ACTUAL,Sage Therapeutics,,1.0,,Sage Therapeutics has decided not to proceed with this study at this time,f,,,,f,t,f,,,,,,,,,NO,Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,INDUSTRY,,,,,,,2021,0.0
NCT03878927,,2019-03-12,,,2023-03-09,2019-03-14,2019-03-18,ACTUAL,,,,,,,2023-03-09,2023-03-10,ACTUAL,2019-08-23,ACTUAL,2019-08-23,2021-12,2021-12-31,2022-09-01,ACTUAL,2022-09-01,2022-08-15,ACTUAL,2022-08-15,,INTERVENTIONAL,CPX GO,,"CPX-351+GO in Subjects 55 Years Old, or Older, With AML","Phase I Trial, With an Expansion Cohort, of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Combination With Gemtuzumab in Subjects With Acute Myeloid Leukemia >55 Years of Age Who Have Not Been Treated With Intensive Chemotherapy",TERMINATED,,PHASE1,11.0,ACTUAL,Weill Medical College of Cornell University,,3.0,,Dose limiting toxicities.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:34:33.073573,2024-10-16 20:34:33.073573,OTHER,,,,,,,2022,0.0
NCT04442126,,2020-06-18,,,2024-02-26,2020-06-19,2020-06-22,ACTUAL,,,,,,,2024-02-26,2024-02-28,ACTUAL,2020-08-19,ACTUAL,2020-08-19,2024-02,2024-02-29,2024-02-06,ACTUAL,2024-02-06,2024-02-06,ACTUAL,2024-02-06,,INTERVENTIONAL,,,A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors,A Phase 1/2 Study of NM21-1480 (Anti-PDL-1/Anti-4-1BB/Anti-HSA Tri-Specific Antibody) in Adult Patients With Advanced Solid Tumors,TERMINATED,,PHASE1/PHASE2,52.0,ACTUAL,Numab Therapeutics AG,,1.0,,A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.,f,,,,t,t,f,,,,,,,,,,,2024-10-14 23:41:57.744149,2024-10-14 23:41:57.744149,INDUSTRY,,,,,,,2024,0.0
NCT04536350,,2020-08-21,,,2024-01-16,2020-09-01,2020-09-02,ACTUAL,,,,,,,2024-01-16,2024-01-18,ACTUAL,2021-05-18,ACTUAL,2021-05-18,2024-01,2024-01-31,2023-06-14,ACTUAL,2023-06-14,2023-06-14,ACTUAL,2023-06-14,,INTERVENTIONAL,,,Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS,"Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS: A Randomized, Placebo Controlled, Multicenter Trial",TERMINATED,,PHASE2,83.0,ACTUAL,"Cantonal Hosptal, Baselland",,2.0,,Difficulties recruiting participants for the Aviptadil study as there are nowadays very few hospitalized COVID patients. Continuous screening has been carried out but none of the patients met the eligibility criteria for the study.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,OTHER,,,,,,,2023,0.0
NCT01515748,,2012-01-10,2020-01-20,,2023-11-20,2012-01-18,2012-01-24,ESTIMATED,2020-02-28,2020-03-02,ACTUAL,,,,2023-11-20,2023-12-13,ACTUAL,2011-12-30,ACTUAL,2011-12-30,2023-11,2023-11-30,2021-12-13,ACTUAL,2021-12-13,2019-01-21,ACTUAL,2019-01-21,,INTERVENTIONAL,PRODIGY,Analysis was performed on Intent-to-Treat (ITT) population which included all randomized participants.,Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer,"A Phase III, Open-labelled, Randomised Study of Neoadjuvant Docetaxel+Oxaliplatin+S-1 (DOS) + Surgery + Adjuvant S-1 Versus Surgery + Adjuvant S-1 in Patients With Resectable Advanced Gastric Cancer",COMPLETED,,PHASE3,530.0,ACTUAL,Sanofi,,2.0,,,f,,,,t,,,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,INDUSTRY,,,,,,,2021,1.0
NCT04531397,,2020-08-26,,,2020-12-24,2020-08-26,2020-08-28,ACTUAL,,,,,,,2020-12-24,2020-12-29,ACTUAL,2021-01-01,ESTIMATED,2021-01-01,2020-12,2020-12-31,2022-12-31,ESTIMATED,2022-12-31,2022-06-01,ESTIMATED,2022-06-01,,INTERVENTIONAL,,,Efficacy and Safety of Dapagliflozin in Children With Proteinuric Chronic Kidney Disease,"Efficacy and Safety of Dapagliflozin in Children With Proteinuric Chronic Kidney Disease : a Prospective, Randomized, Placebo-controlled Trial",WITHDRAWN,,PHASE4,0.0,ACTUAL,Children's Hospital of Fudan University,,2.0,,lack of funding,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,OTHER,,,,,,,2022,0.0
NCT02794285,,2016-06-06,2022-12-19,,2022-12-19,2016-06-06,2016-06-09,ESTIMATED,2022-12-19,2023-01-13,ACTUAL,,,,2022-12-19,2023-01-13,ACTUAL,2016-06-30,ACTUAL,2016-06-30,2022-12,2022-12-31,2021-12-21,ACTUAL,2021-12-21,2021-12-21,ACTUAL,2021-12-21,,INTERVENTIONAL,TULIP SLE LTE,Full Analysis Set (FAS) - LTE Study: consisted of all participants who were randomised and received at least 1 dose of investigational product in the LTE Study.,Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus,"A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.",COMPLETED,,PHASE3,559.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,INDUSTRY,,,,,,,2021,1.0
NCT03598270,,2018-06-02,,,2024-08-28,2018-07-24,2018-07-26,ACTUAL,,,,,,,2024-08-28,2024-08-30,ACTUAL,2018-11-21,ACTUAL,2018-11-21,2024-08,2024-08-31,2024-08-05,ACTUAL,2024-08-05,2024-08-05,ACTUAL,2024-08-05,,INTERVENTIONAL,ANITA,,Platinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer,"A Phase III Randomized, Double-blinded Trial of Platinum-based Chemotherapy With or Without Atezolizumab Followed by Niraparib Maintenance With or Without Atezolizumab in Patients With Recurrent Ovarian, Tubal or Peritoneal Cancer and Platinum Treatment-free Interval (TFIp) >6 Months",COMPLETED,,PHASE3,417.0,ACTUAL,Grupo Español de Investigación en Cáncer de Ovario,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 13:42:53.582361,2024-10-15 13:42:53.582361,OTHER,,,,,,,2024,0.0
NCT05794672,,2023-02-20,,,2023-07-17,2023-03-20,2023-04-03,ACTUAL,,,,,,,2023-07-17,2023-07-18,ACTUAL,2023-04-11,ACTUAL,2023-04-11,2023-07,2023-07-31,2023-07-08,ACTUAL,2023-07-08,2023-07-08,ACTUAL,2023-07-08,,INTERVENTIONAL,,,"A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Elarekibep in Healthy Japanese Subjects","A Phase 1, Randomised, Single-blind, Placebo-controlled, Single-centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Elarekibep Given Twice Daily as Inhaled or a Single IV Formulation in Healthy Japanese Subjects",TERMINATED,,PHASE1,30.0,ACTUAL,AstraZeneca,,2.0,,"This decision was based on lung findings from a non-clinical 13-week GLP toxicology study, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development.",f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,INDUSTRY,,,,,,,2023,0.0
NCT03139604,,2017-05-02,2020-05-01,,2021-07-13,2017-05-02,2017-05-04,ACTUAL,2020-05-01,2020-05-15,ACTUAL,,,,2021-07-13,2021-08-11,ACTUAL,2017-07-19,ACTUAL,2017-07-19,2021-07,2021-07-31,2020-07-13,ACTUAL,2020-07-13,2019-05-02,ACTUAL,2019-05-02,,INTERVENTIONAL,,,GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease,"GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease",COMPLETED,,PHASE3,439.0,ACTUAL,Incyte Corporation,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,INDUSTRY,,,,,,,2020,1.0
NCT03525392,,2018-05-03,2022-04-22,,2023-02-23,2018-05-03,2018-05-15,ACTUAL,2023-02-23,2023-12-12,ACTUAL,,,,2023-02-23,2023-12-12,ACTUAL,2018-05-03,ACTUAL,2018-05-03,2023-02,2023-02-28,2021-04-28,ACTUAL,2021-04-28,2020-04-03,ACTUAL,2020-04-03,,INTERVENTIONAL,,Included population contained all screened participants who were included in the study and received the therapeutic dose.,Study to Evaluate the Safety and Activity (Including Distribution) of 177Lu-3BP-227 in Subjects With Solid Tumours Expressing Neurotensin Receptor Type 1.,"An International Multicentre, Open-Label First in Human Phase I/II Study to Evaluate the Safety, Tolerability, Biodistribution and Antitumour Activity of 177Lu-3BP-227 for the Treatment of Subjects With Solid Tumours Expressing Neurotensin Receptor 1",TERMINATED,,PHASE1,14.0,ACTUAL,Ipsen,"The sponsor terminated the study early and phase 1 dose expansion and phase 2 were not started. The decision to terminate the study was not due to any safety or tolerability concern, or any event associated with the use of 177Lu-3BP-227.",1.0,,"Due to agreement to transfer rights for IPN01087 to an external partner, not due to safety concerns",f,,,,,t,f,,,f,,,,,,,,2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,INDUSTRY,,,,,,,2021,0.0
NCT04655027,,2020-12-03,2022-08-11,,2024-04-09,2020-12-03,2020-12-04,ACTUAL,2024-04-09,2024-04-22,ACTUAL,,,,2024-04-09,2024-04-22,ACTUAL,2021-02-22,ACTUAL,2021-02-22,2024-04,2024-04-30,2021-10-12,ACTUAL,2021-10-12,2021-10-12,ACTUAL,2021-10-12,,INTERVENTIONAL,,The Full analysis Set (FAS) was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis.,A Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD),"ALTAI: An Open-Label, Randomized, Active-Controlled, Parallel Design, Multicenter Phase IV Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)",COMPLETED,,PHASE4,25.0,ACTUAL,AstraZeneca,* NDD randomization strata were merged because recruitment was insufficient.~* The log-transform of AUC was removed from the primary assessment post-database-lock when negative AUC were discovered (which invalidated log-transformation).,2.0,,,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,INDUSTRY,,,,,,,2021,1.0
NCT03689829,,2018-09-20,,,2020-03-16,2018-09-26,2018-09-28,ACTUAL,,,,,,,2020-03-16,2020-03-18,ACTUAL,2018-08-13,ACTUAL,2018-08-13,2020-03,2020-03-31,2020-03-02,ACTUAL,2020-03-02,2020-03-02,ACTUAL,2020-03-02,,INTERVENTIONAL,,,"A Study to Test Safety, Tolerability, and the Way the Body Absorbs, Distributes, and Gets Rid of a Study Drug Called MOR106, in Healthy Subjects and in Patients With Moderate to Severe Atopic Dermatitis","A Parallel-design Phase 1 Study to Assess Safety, Tolerability and Pharmacokinetics/Exposure Following Different Single Dose Levels of MOR106 (Administered Subcutaneously or Intravenously) in Healthy Male Subjects (Randomized, Open-label), and in Subjects With Moderate to Severe Atopic Dermatitis (Randomized, Placebo-controlled, Double-blind, Repeated Subcutaneous Dosing Over 12 Weeks)",TERMINATED,,PHASE1,44.0,ACTUAL,Galapagos NV,,8.0,,MOR106 clinical development in atopic dermatitis was stopped for futility,f,,,,f,f,f,,,,,,,,,,,2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,INDUSTRY,,,,,,,2020,0.0
NCT04145700,,2019-10-29,2023-08-23,,2023-08-23,2019-10-29,2019-10-31,ACTUAL,2023-08-23,2023-09-13,ACTUAL,,,,2023-08-23,2023-09-13,ACTUAL,2020-03-04,ACTUAL,2020-03-04,2023-08,2023-08-31,2023-02-23,ACTUAL,2023-02-23,2023-02-23,ACTUAL,2023-02-23,,INTERVENTIONAL,,All randomized participants.,CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma,"A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Synovial Sarcoma",TERMINATED,,PHASE1/PHASE2,23.0,ACTUAL,Eli Lilly and Company,The limitation to this study was the highly varied estimates of the PFS HR and the probability of PFS HR \< 1 due to influence from the matched historical controls whose PFS substantially outperformed PFS from the prospectively randomized control.,2.0,,Study terminated for meeting protocol specified futility criteria.,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,INDUSTRY,,,,,,,2023,0.0
NCT04187508,,2019-12-03,,,2020-11-02,2019-12-03,2019-12-05,ACTUAL,,,,,,,2020-11-02,2020-11-03,ACTUAL,2020-02-06,ACTUAL,2020-02-06,2020-11,2020-11-30,2021-11-10,ESTIMATED,2021-11-10,2021-11-10,ESTIMATED,2021-11-10,,INTERVENTIONAL,,,A Study to Evaluate the Effect of AZD8154 Administered Via Nebulizer Once Daily in Subjects With Mild Allergic Asthma Challenged With an Inhaled Allergen,"A Phase IIa, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Multi-Centre Study to Evaluate the Effect of AZD8154 Administered Via Nebulizer Once Daily on Allergen-Induced Inflammation in Subjects With Mild Allergic Asthma Challenged With an Inhaled Allergen",WITHDRAWN,,PHASE2,0.0,ACTUAL,AstraZeneca,,2.0,,The reason is: emerging pre-clinical toxicology findings.,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,INDUSTRY,,,,,,,2021,0.0
NCT02519140,,2014-08-17,,,2023-11-28,2015-08-07,2015-08-10,ESTIMATED,,,,,,,2023-11-28,2023-12-04,ACTUAL,2014-08-01,ACTUAL,2014-08-01,2023-10,2023-10-31,2022-11-30,ACTUAL,2022-11-30,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,,,Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections,Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections,WITHDRAWN,,PHASE3,0.0,ACTUAL,Maimonides Medical Center,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,OTHER,,,,,,,2022,0.0
NCT03845140,,2019-02-15,2022-09-27,,2023-09-08,2019-02-15,2019-02-19,ACTUAL,2023-09-08,2024-03-21,ACTUAL,,,,2023-09-08,2024-03-21,ACTUAL,2019-09-02,ACTUAL,2019-09-02,2023-09,2023-09-30,2021-10-11,ACTUAL,2021-10-11,2021-10-11,ACTUAL,2021-10-11,,INTERVENTIONAL,,Safety analysis population (SAF) included all participants who received 1 dose of study treatment.,L-PZQ ODT in Schistosoma Infected Children,"An Open Label, Phase III Efficacy and Safety Study of L-PZQ ODT in Schistosoma Infected Children 3 Months to 6 Years of Age, Including a 2:1 Randomized, Controlled Cohort of Schistosoma Mansoni Infected Children 4 to 6 Years of Age Treated With L PZQ ODT or Commercial PZQ (Biltricide®)",COMPLETED,,PHASE3,288.0,ACTUAL,"Merck KGaA, Darmstadt, Germany",,6.0,,,f,,,,t,f,f,,,,,,Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union,Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.,http://bit.ly/IPD21,YES,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21",2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,INDUSTRY,,,,,,,2021,1.0
NCT04049266,,2019-08-06,2024-04-04,,2024-07-16,2019-08-06,2019-08-08,ACTUAL,2024-07-16,2024-07-18,ACTUAL,,,,2024-07-16,2024-07-18,ACTUAL,2019-10-08,ACTUAL,2019-10-08,2024-06,2024-06-30,2022-04-26,ACTUAL,2022-04-26,2021-11-17,ACTUAL,2021-11-17,,INTERVENTIONAL,DAZZLE,All randomized subjects who received at least one active study treatment (KSI-301 or aflibercept),"A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.","A Phase 2b/3, Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in Subjects With Neovascular (Wet) Age-related Macular Degeneration.",TERMINATED,,PHASE2/PHASE3,559.0,ACTUAL,Kodiak Sciences Inc,"This study was terminated early by the Sponsor because the study did not meet the primary endpoint. Thus, not all participants in this study completed the full duration of treatment.",2.0,,Primary Endpoint Not Met,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,INDUSTRY,,,,,,,2022,0.0
NCT04687137,,2020-12-03,2023-06-01,,2023-06-01,2020-12-25,2020-12-29,ACTUAL,2023-06-01,2023-06-26,ACTUAL,,,,2023-06-01,2023-06-26,ACTUAL,2021-02-10,ACTUAL,2021-02-10,2023-06,2023-06-30,2022-06-18,ACTUAL,2022-06-18,2022-06-18,ACTUAL,2022-06-18,,INTERVENTIONAL,,Full Analysis Set (FAS) included all participants who received at least 1 dose of study drug.,Expanded Access Program With Lanadelumab for Japanese People With Hereditary Angioedema,"Open-arm, Japan Expanded Access Program With Lanadelumab (TAK-743) for Japanese Patients With Hereditary Angioedema",COMPLETED,,PHASE3,12.0,ACTUAL,Takeda,,1.0,,,f,,,,f,t,f,,,t,,,,,,NO,De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).,2024-10-16 21:24:29.407204,2024-10-16 21:24:29.407204,INDUSTRY,,,,,,,2022,0.0
NCT04933383,,2021-05-31,2024-04-02,,2024-08-29,2021-06-15,2021-06-21,ACTUAL,2024-08-29,2024-09-03,ACTUAL,,,,2024-08-29,2024-09-03,ACTUAL,2021-07-23,ACTUAL,2021-07-23,2024-08,2024-08-31,2023-01-31,ACTUAL,2023-01-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,BOREAS,The efficacy population encompasses all subjects that completed both treatment periods and for which the primary efficacy parameters PC20 is available at baseline (visit 1) and after both treatment periods (visit 2 and visit 4).~The safety population includes all randomized subjects who received at least one dose of the study medication (AQ001S or comparator).,Crossover Trial to Assess Efficacy and Safety of Inhaled AQ001S Compared to a Budesonide Suspension in Mild Asthmatics,"A Prospective, Active-controlled, Randomized, Open Label, Single-center, Multiple Dose, Crossover Clinical Trial to Assess the Efficacy, Safety and PK of AQ001S Compared to a Budesonide Inhalation Suspension in Adults With Mild Asthma",COMPLETED,,PHASE1/PHASE2,23.0,ACTUAL,Aquilon Pharmaceuticals S.A.,No limitations or caveat are reported for this trial.,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,INDUSTRY,,,,,,,2023,1.0
NCT03318523,,2017-10-19,2021-10-25,,2022-02-15,2017-10-19,2017-10-24,ACTUAL,2021-10-25,2021-11-23,ACTUAL,,,,2022-02-15,2022-02-28,ACTUAL,2018-01-10,ACTUAL,2018-01-10,2022-02,2022-02-28,2021-04-29,ACTUAL,2021-04-29,2020-10-26,ACTUAL,2020-10-26,,INTERVENTIONAL,SPARK,Intent-to-treat (ITT) population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo).,"Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease",TERMINATED,,PHASE2,357.0,ACTUAL,Biogen,The study did not meet its primary outcome measure for year 1 and did not demonstrate efficacy on key secondary outcome measures; additional pre-specified analyses at week 72 confirmed the study did not provide evidence of efficacy; resulting in the development of BIIB054 for Parkinson's disease to be discontinued and SPARK study was closed.,4.0,,SPARK did not meet it's primary outcome measure for year 1 and failed to meet secondary outcome measures resulting in the development of BIIB054 (cinpanemab) for Parkinson's disease to be discontinued and SPARK study was closed.,f,,,,t,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,INDUSTRY,,,,,,,2021,0.0
NCT04921969,,2021-06-07,2024-05-08,,2024-06-07,2021-06-07,2021-06-10,ACTUAL,2024-06-07,2024-06-10,ACTUAL,,,,2024-06-07,2024-06-10,ACTUAL,2021-07-19,ACTUAL,2021-07-19,2024-06,2024-06-30,2024-04-08,ACTUAL,2024-04-08,2023-05-10,ACTUAL,2023-05-10,,INTERVENTIONAL,,,A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3),"A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Children (Ages≥ 2 Years to < 12 Years) With Atopic Dermatitis ((TRuE-AD3)",COMPLETED,,PHASE3,330.0,ACTUAL,Incyte Corporation,,3.0,,,f,,,,f,t,f,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency.,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,INDUSTRY,,,,,,,2024,1.0
NCT05359874,,2021-05-14,,,2022-04-28,2022-04-28,2022-05-04,ACTUAL,,,,,,,2022-04-28,2022-05-04,ACTUAL,2021-06,ESTIMATED,2021-06-30,2021-05,2021-05-31,2023-03,ESTIMATED,2023-03-31,2023-03,ESTIMATED,2023-03-31,,INTERVENTIONAL,DoT-FMI,,Improvement of the Operative Outcome in Patients With Primary VEGF + Unifocal Breast Cancer or DCIS Through the Intraoperative Visualization of the Tumor Using Molecular Imaging and Bevacizumab-IRDye-800CW,Improvement of the Operative Outcome in Patients With Primary VEGF Positive Unifocal Breast Cancer or Ductal Carcinoma in Situ (DCIS) Through the Intraoperative Visualization of the Tumor Using Molecular Imaging and Fluorescent Markers Bevacizumab-IRDye-800CW,WITHDRAWN,,PHASE2,0.0,ACTUAL,Technical University of Munich,,1.0,,application has been withdrawn,f,,,,f,f,f,,,,,,,,,UNDECIDED,no patient specific data will be shared,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,OTHER,,,,,,,2023,0.0
NCT03359785,,2017-11-27,2023-12-08,2021-12-07,2024-01-30,2017-11-27,2017-12-02,ACTUAL,2024-01-30,2024-02-28,ACTUAL,,2024-02-28,ACTUAL,2024-01-30,2024-02-28,ACTUAL,2018-01-10,ACTUAL,2018-01-10,2024-01,2024-01-31,2020-12-21,ACTUAL,2020-12-21,2020-12-21,ACTUAL,2020-12-21,,INTERVENTIONAL,,The safety analysis set included all participants who were randomized and received at least 1 dose of double-blind study drug.,A Study to Evaluate Multiple Oral Doses of Luvadaxistat in Adults With Schizophrenia,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate Pharmacodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of TAK-831 in Adult Subjects With Schizophrenia",COMPLETED,,PHASE2,31.0,ACTUAL,Neurocrine Biosciences,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,INDUSTRY,,,,,,,2020,1.0
NCT03377699,,2017-11-16,2021-12-15,,2023-01-19,2017-12-14,2017-12-19,ACTUAL,2022-03-29,2022-04-27,ACTUAL,,,,2023-01-19,2023-01-20,ACTUAL,2017-11-22,ACTUAL,2017-11-22,2023-01,2023-01-31,2020-12-17,ACTUAL,2020-12-17,2020-12-17,ACTUAL,2020-12-17,,INTERVENTIONAL,EXPECT,FASall: included all randomised women contributed to the evaluation.,"Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes","A Trial Comparing the Effect and Safety of Insulin Degludec Versus Insulin Detemir, Both in Combination With Insulin Aspart, in the Treatment of Pregnant Women With Type 1 Diabetes",COMPLETED,,PHASE3,225.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,t,t,f,,,t,,,,,,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,INDUSTRY,,,,,,,2020,1.0
NCT04452435,,2020-06-29,2021-03-24,,2021-06-21,2020-06-29,2020-06-30,ACTUAL,2021-04-28,2021-04-30,ACTUAL,,,,2021-06-21,2021-06-23,ACTUAL,2020-07-21,ACTUAL,2020-07-21,2021-06,2021-06-30,2020-10-13,ACTUAL,2020-10-13,2020-10-13,ACTUAL,2020-10-13,,INTERVENTIONAL,,,Safety and Efficacy of C21 in Subjects With COVID-19,"A Randomised, Double-blind, Placebo-controlled, Phase 2 Trial Investigating the Safety and Efficacy of C21 in Hospitalised Subjects With COVID-19 Infection Not Requiring Mechanical Ventilation",COMPLETED,,PHASE2,206.0,ACTUAL,Vicore Pharma AB,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,INDUSTRY,,,,,,,2020,1.0
NCT04162769,,2019-11-12,2022-08-24,2021-09-13,2022-10-10,2019-11-12,2019-11-14,ACTUAL,2022-10-10,2022-11-04,ACTUAL,2022-10-10,2022-11-04,ACTUAL,2022-10-10,2022-11-04,ACTUAL,2019-10-04,ACTUAL,2019-10-04,2022-10,2022-10-31,2021-10-11,ACTUAL,2021-10-11,2020-09-09,ACTUAL,2020-09-09,,INTERVENTIONAL,ADVISE,"Full Analysis Set (FAS) included all randomized participants, irrespective of whether they received any study intervention.",A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis,"A Multicenter, Randomized, Double-Blinded, Placebo-Controlled 16-Week Study (With a 52-Week Open-Label Extension) to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis",COMPLETED,,PHASE2,140.0,ACTUAL,Arena Pharmaceuticals,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,INDUSTRY,,,,,,,2021,1.0
NCT01062425,,2010-02-03,2016-07-28,,2022-06-28,2010-02-03,2010-02-04,ESTIMATED,2016-07-28,2016-09-19,ESTIMATED,,,,2022-06-28,2022-07-26,ACTUAL,2010-02-26,ACTUAL,2010-02-26,2022-05,2022-05-31,2022-05-20,ACTUAL,2022-05-20,2015-12-06,ACTUAL,2015-12-06,,INTERVENTIONAL,,All randomized and eligible patients.,Temozolomide and Radiation Therapy With or Without Cediranib Maleate in Treating Patients With Newly Diagnosed Glioblastoma,"Randomized, Phase II, Double-Blind, Placebo-Controlled Trial of Conventional Chemoradiation and Adjuvant Temozolomide Plus Cediranib Versus Conventional Chemoradiation and Adjuvant Temozolomide Plus Placebo in Patients With Newly Diagnosed Glioblastoma",COMPLETED,,PHASE2,261.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,NIH,,,,,,,2022,1.0
NCT03347110,,2017-11-15,2023-10-26,2021-10-28,2023-11-29,2017-11-15,2017-11-20,ACTUAL,2023-11-29,2023-12-01,ACTUAL,,2023-12-01,ACTUAL,2023-11-29,2023-12-01,ACTUAL,2017-11-22,ACTUAL,2017-11-22,2023-11,2023-11-30,2020-10-29,ACTUAL,2020-10-29,2020-10-29,ACTUAL,2020-10-29,,INTERVENTIONAL,BE ACTIVE 2,Baseline Characteristics refer to SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.,A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis,"A Multicenter, Open-Label, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis",COMPLETED,,PHASE2,184.0,ACTUAL,UCB Pharma,,1.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,INDUSTRY,,,,,,,2020,1.0
NCT03047395,,2017-02-07,,,2023-12-06,2017-02-07,2017-02-09,ESTIMATED,,,,,,,2023-12-06,2023-12-12,ACTUAL,2017-02-27,ACTUAL,2017-02-27,2023-12,2023-12-31,2023-11-29,ACTUAL,2023-11-29,2023-11-29,ACTUAL,2023-11-29,,INTERVENTIONAL,LIMMITLESS,,A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS ),"A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS)",COMPLETED,,PHASE3,2172.0,ACTUAL,AbbVie,,1.0,,,f,,,,t,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,INDUSTRY,,,,,,,2023,1.0
NCT04982289,,2021-06-21,,,2022-02-02,2021-07-20,2021-07-29,ACTUAL,,,,,,,2022-02-02,2022-02-11,ACTUAL,2022-01-01,ESTIMATED,2022-01-01,2022-02,2022-02-28,2024-01-31,ESTIMATED,2024-01-31,2023-01-31,ESTIMATED,2023-01-31,,INTERVENTIONAL,,,Study of ALXN1830 Administered Subcutaneously in Adults With Generalized Myasthenia Gravis,"A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALXN1830 Administered Subcutaneously in Adult Patients With Generalized Myasthenia Gravis",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,3.0,,Sponsor decision to terminate program,,,,,f,t,f,,,,,,,,,,,2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,INDUSTRY,,,,,,,2024,0.0
NCT04838795,,2021-02-17,,,2022-07-29,2021-04-06,2021-04-09,ACTUAL,,,,,,,2022-07-29,2022-08-01,ACTUAL,2021-02-17,ACTUAL,2021-02-17,2021-10,2021-10-31,2022-03-31,ACTUAL,2022-03-31,2022-03-31,ACTUAL,2022-03-31,,INTERVENTIONAL,Sisonke,,Sisonke (Together): OPEN LABEL TRIAL COVID-19,"Open-label, Single-arm Phase 3B Implementation Study to Monitor the Effectiveness of the Single-dose Ad26.COV2.S COVID-19 Vaccine Among Health Care Workers in South Africa (VAC31518COV3012)",COMPLETED,,PHASE3,477102.0,ACTUAL,Wits Health Consortium (Pty) Ltd,,,,,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,OTHER,,,,,,,2022,1.0
NCT05024825,,2019-08-04,,,2021-08-26,2021-08-26,2021-08-27,ACTUAL,,,,,,,2021-08-26,2021-08-27,ACTUAL,2017-08-04,ACTUAL,2017-08-04,2021-08,2021-08-31,2021-05-19,ACTUAL,2021-05-19,2021-05-19,ACTUAL,2021-05-19,,INTERVENTIONAL,,,Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy,Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy,TERMINATED,,PHASE4,17.0,ACTUAL,Albany Medical College,,2.0,,recruitment target not met.,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,OTHER,,,,,,,2021,0.0
NCT04443868,,2020-06-20,,,2021-07-12,2020-06-20,2020-06-23,ACTUAL,,,,,,,2021-07-12,2021-07-16,ACTUAL,2021-01,ESTIMATED,2021-01-31,2021-07,2021-07-31,2021-07,ESTIMATED,2021-07-31,2021-04,ESTIMATED,2021-04-30,,INTERVENTIONAL,,,Nitric Oxide Releasing Solution to Treat and Prevent Exacerbation of Mild COVID-19 Infection,"Double-Blinded, Placebo-Controlled Parallel, Phase II Clinical Efficacy Study Evaluating NORS To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Mild COVID-19",WITHDRAWN,,PHASE2,0.0,ACTUAL,Sanotize Research and Development corp.,,2.0,,No subjects enrolled,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,INDUSTRY,,,,,,,2021,0.0
NCT05302804,,2022-03-17,2023-12-13,,2024-03-29,2022-03-29,2022-03-31,ACTUAL,2024-03-29,2024-04-24,ACTUAL,,,,2024-03-29,2024-04-24,ACTUAL,2022-05-01,ACTUAL,2022-05-01,2024-03,2024-03-31,2022-10-01,ACTUAL,2022-10-01,2022-10-01,ACTUAL,2022-10-01,,INTERVENTIONAL,,,The Influence of Menthol Gel During Exercise With Heat,The Influence of Topical Menthol Gel on Thermoregulatory and Perceptual Outcomes During Exercise Within the Heat,COMPLETED,,PHASE4,12.0,ACTUAL,University of Nebraska,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,OTHER,,,,,,,2022,1.0
NCT03831191,,2019-02-04,2021-02-12,,2021-03-24,2019-02-04,2019-02-05,ACTUAL,2021-03-24,2021-04-20,ACTUAL,,,,2021-03-24,2021-04-20,ACTUAL,2019-02-12,ACTUAL,2019-02-12,2020-06,2020-06-30,2020-02-27,ACTUAL,2020-02-27,2020-02-27,ACTUAL,2020-02-27,,INTERVENTIONAL,ADmIRe,All randomized participants.,A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3375880 in Adult Subjects With Moderate-to-Severe Atopic Dermatitis: The ADmIRe Study",TERMINATED,,PHASE2,136.0,ACTUAL,Eli Lilly and Company,The study was terminated for lack of efficacy after an interim analysis was performed.,4.0,,The study was terminated for lack of efficacy after an interim analysis was performed,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://www.clinicalstudydatarequest.com,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,INDUSTRY,,,,,,,2020,0.0
NCT03238651,,2017-08-01,2021-08-17,,2023-02-06,2017-08-01,2017-08-03,ACTUAL,2021-08-17,2021-09-14,ACTUAL,,,,2023-02-06,2023-02-08,ACTUAL,2017-08-01,ACTUAL,2017-08-01,2023-02,2023-02-28,2020-08-17,ACTUAL,2020-08-17,2020-08-17,ACTUAL,2020-08-17,,INTERVENTIONAL,,The safety analysis set included participants who received at least 1 dose of study drug.,A Study of TAK-659 as a Single Agent in Adult East Asian Participants With Non-Hodgkin Lymphoma (NHL),"A Phase 1, Open-label Study of TAK-659 as a Single Agent in Adult East Asian Patients With Non-Hodgkin Lymphoma",TERMINATED,,PHASE1,17.0,ACTUAL,"Calithera Biosciences, Inc",,3.0,,Termination of the study by the sponsor due to business decision.,f,,,,f,f,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,INDUSTRY,,,,,,,2020,0.0
NCT04785144,,2021-03-04,2023-06-22,,2024-03-14,2021-03-04,2021-03-05,ACTUAL,2023-08-31,2023-09-13,ACTUAL,,,,2024-03-14,2024-03-18,ACTUAL,2021-03-31,ACTUAL,2021-03-31,2021-04-06,2021-04-06,2022-07-05,ACTUAL,2022-07-05,2022-07-05,ACTUAL,2022-07-05,,INTERVENTIONAL,,,Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults,"Phase 1, Open-Label, Randomized Study of the Safety and Immunogenicity of a SARS-CoV-2 Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults",COMPLETED,,PHASE1,135.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,10.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,NIH,,,,,,,2022,1.0
NCT01416636,,2011-08-12,2018-03-01,,2022-05-17,2011-08-12,2011-08-15,ESTIMATED,2019-03-08,2019-06-10,ACTUAL,,,,2022-05-17,2022-06-07,ACTUAL,2009-03,,2009-03-31,2022-05,2022-05-31,2021-04,ACTUAL,2021-04-30,2016-11,ACTUAL,2016-11-30,,INTERVENTIONAL,CTREPH,,Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Non-operable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH),A Double Blind Controlled Clinical Study to Investigate the Efficacy and Tolerability of Subcutaneous Treprostinil Sodium in Patients With Severe Non-operable Chronic Thromboembolic Pulmonary Hypertension (CTREPH),COMPLETED,,PHASE3,105.0,ACTUAL,SciPharm SàRL,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,INDUSTRY,,,,,,,2021,1.0
NCT04365582,,2020-04-23,,,2021-04-26,2020-04-26,2020-04-28,ACTUAL,,,,,,,2021-04-26,2021-04-27,ACTUAL,2020-05-07,ACTUAL,2020-05-07,2020-04,2020-04-30,2021-04-19,ACTUAL,2021-04-19,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,OUTCOV,,OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome,A Randomized Trial of Efficacy and Safety of an Early OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome: a Strategy to Prevent Hospitalization,WITHDRAWN,,PHASE3,0.0,ACTUAL,Fondation Hôpital Saint-Joseph,,4.0,,The PI decided.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,OTHER,,,,,,,2021,0.0
NCT05327816,,2022-04-13,2023-12-12,,2024-02-02,2022-04-13,2022-04-14,ACTUAL,2023-12-12,2024-01-02,ACTUAL,,,,2024-02-02,2024-02-05,ACTUAL,2022-04-13,ACTUAL,2022-04-13,2024-02,2024-02-29,2023-02-14,ACTUAL,2023-02-14,2023-01-16,ACTUAL,2023-01-16,,INTERVENTIONAL,,"The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.",A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Years and Older,"A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations of Various RSV.preF-based Vaccine Formulations in Adults Aged 60 Years and Older",TERMINATED,,PHASE1/PHASE2,132.0,ACTUAL,Janssen Vaccines & Prevention B.V.,"Study was terminated on sponsor's decision, hence, participants were enrolled in Cohort 1 only. Cohorts 2, 3, and 4 were not initiated. Participants enrolled in Cohort 1 completed visit up to Day 183 (6-months post vaccination) and safety evaluations were performed only for Cohort 1. Since the study was terminated prior to Cohort 2 enrolment and the data was planned for combined Cohorts 1 and 2, samples collected in Cohort 1 alone were not tested and no immunogenicity testing was performed.",19.0,,"Based on recent study data from VAC18193, it was decided to terminate the study. There are no underlying safety concerns to terminate VAC18195RSV1001",f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,INDUSTRY,,,,,,,2023,0.0
NCT05400577,,2022-04-29,,,2023-07-13,2022-05-31,2022-06-01,ACTUAL,,,,,,,2023-07-13,2023-07-17,ACTUAL,2022-07-13,ACTUAL,2022-07-13,2023-07,2023-07-31,2024-02-01,ESTIMATED,2024-02-01,2024-01-01,ESTIMATED,2024-01-01,,INTERVENTIONAL,,,"Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC","Neoadjuvant Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA Non-Small Cell Lung Cancer (NSCLC)",WITHDRAWN,,PHASE2,0.0,ACTUAL,Fox Chase Cancer Center,,1.0,,Grantor withdrew support due to slow accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,OTHER,,,,,,,2024,0.0
NCT03255083,,2017-08-17,2021-08-30,,2022-01-10,2017-08-17,2017-08-21,ACTUAL,2021-11-11,2022-01-11,ACTUAL,,,,2022-01-10,2022-01-19,ACTUAL,2019-04-10,ACTUAL,2019-04-10,2022-01,2022-01-31,2020-09-04,ACTUAL,2020-09-04,2020-09-04,ACTUAL,2020-09-04,,INTERVENTIONAL,,Demographic and baseline characteristics were assessed in the Full Analysis Set.,DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer,"A Multicenter, Open-Label Phase 1 Study of DS-1205c in Combination With Osimertinib in Subjects With Metastatic or Unresectable EGFR-Mutant Non-Small Cell Lung Cancer",TERMINATED,,PHASE1,13.0,ACTUAL,Daiichi Sankyo,This study was terminated based on a business decision by the Sponsor.,1.0,,This study was terminated based on a business decision by the Sponsor.,f,,,,f,f,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,INDUSTRY,,,,,,,2020,0.0
NCT05386550,,2022-05-17,,,2024-09-20,2022-05-17,2022-05-23,ACTUAL,,,,,,,2024-09-20,2024-09-23,ACTUAL,2022-10-06,ACTUAL,2022-10-06,2024-09,2024-09-30,2024-08-27,ACTUAL,2024-08-27,2024-08-27,ACTUAL,2024-08-27,,INTERVENTIONAL,,,"Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)","A Randomized, Double-blind, Placebo-controlled, 2-arm Phase III Study to Assess Efficacy and Safety of Xevinapant and Radiotherapy Compared to Placebo and Radiotherapy for Demonstrating Improvement of Disease-free Survival in Participants With Resected Squamous Cell Carcinoma of the Head and Neck, Who Are at High Risk for Relapse and Are Ineligible for High-dose Cisplatin (XRAY VISION)",TERMINATED,,PHASE3,166.0,ACTUAL,EMD Serono,,2.0,,"No major safety concerns were identified in XRAY VISION study, but Lack of evidence of efficacy of meaningful clinical benefit.",f,,,,t,t,f,,,,,,Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union,Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.,http://bit.ly/IPD21,YES,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21",2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,INDUSTRY,,,,,,,2024,0.0
NCT03872336,,2019-03-11,,,2020-07-20,2019-03-12,2019-03-13,ACTUAL,,,,,,,2020-07-20,2020-07-22,ACTUAL,2019-02-18,ACTUAL,2019-02-18,2020-07,2020-07-31,2020-07-20,ACTUAL,2020-07-20,2020-07-20,ACTUAL,2020-07-20,,INTERVENTIONAL,ALERT,,Acute Labetalol Use in Preeclampsia,Acute Labetalol Use in Preeclampsia Randomized Trial,TERMINATED,,PHASE4,15.0,ACTUAL,Albany Medical College,,2.0,,Slow enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,OTHER,,,,,,,2020,0.0
NCT03699904,,2018-10-01,,,2020-09-28,2018-10-05,2018-10-09,ACTUAL,,,,,,,2020-09-28,2020-09-30,ACTUAL,2018-10-11,ACTUAL,2018-10-11,2020-09,2020-09-30,2020-07-01,ACTUAL,2020-07-01,2020-05-07,ACTUAL,2020-05-07,,INTERVENTIONAL,EViSCO,,Epstein-Barr Virus Suppression in Chronic Obstructive Pulmonary Disease (EViSCO): a Phase 2 Randomised Control Trial,"A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Effect of Epstein-Barr Virus Suppression in Chronic Obstructive Pulmonary Disease (EViSCO).",TERMINATED,,PHASE2,85.0,ACTUAL,Belfast Health and Social Care Trust,,2.0,,In light of the evolving Covid19 pandemic ongoing study recruitment was felt to pose an unacceptable risk to patient safety.,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,OTHER,,,,,,,2020,0.0
NCT04480138,,2020-07-20,,,2022-07-08,2020-07-20,2020-07-21,ACTUAL,,,,,,,2022-07-08,2022-07-12,ACTUAL,2020-08-11,ACTUAL,2020-08-11,2021-06,2021-06-30,2021-06-21,ACTUAL,2021-06-21,2021-06-21,ACTUAL,2021-06-21,,INTERVENTIONAL,,,Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19),"A Phase II, Multicenter, Open-label, Randomized, Comparator Controlled Study to Evaluate the Efficacy and Safety of Pegylated Interferon - α2b in the Treatment of Adult Patients Diagnosed With SARS-CoV2 (COVID-19)",TERMINATED,,PHASE2,7.0,ACTUAL,Zydus Lifesciences Limited,,2.0,,Due to non availability of eligible subjects and slow recruitment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 00:10:40.306149,2024-10-16 00:10:40.306149,INDUSTRY,,,,,,,2021,0.0
NCT03073200,,2017-03-03,2020-02-06,,2021-08-30,2017-03-03,2017-03-08,ACTUAL,2020-03-06,2020-03-17,ACTUAL,,,,2021-08-30,2021-09-27,ACTUAL,2017-03-28,ACTUAL,2017-03-28,2021-08-16,2021-08-16,2021-03-23,ACTUAL,2021-03-23,2019-02-07,ACTUAL,2019-02-07,,INTERVENTIONAL,Ixora-peds,,Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis,"Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients From 6 to Less Than 18 Years of Age With Moderate-to-Severe Plaque Psoriasis",COMPLETED,,PHASE3,201.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,INDUSTRY,,,,,,,2021,1.0
NCT04684121,,2020-12-17,,,2023-06-19,2020-12-21,2020-12-24,ACTUAL,,,,,,,2023-06-19,2023-06-22,ACTUAL,2022-08-01,ESTIMATED,2022-08-01,2023-06,2023-06-30,2024-08-01,ESTIMATED,2024-08-01,2024-08-01,ESTIMATED,2024-08-01,,INTERVENTIONAL,,,Study of the Efficacy and Safety of Granexin® Gel to Improve Burn Wound Healing,"A Phase 2, Prospective, Randomized, Double-Blind, Parallel-Group, Within-Subject Vehicle Controlled Multicenter Study of the Efficacy and Safety of Granexin® Gel to Improve Burn Wound Healing",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Xequel Bio, Inc.",,2.0,,No longer aligned with company strategy,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,OTHER,,,,,,,2024,0.0
NCT05538312,,2022-09-08,2024-04-19,,2024-04-19,2022-09-08,2022-09-13,ACTUAL,2024-04-19,2024-09-23,ACTUAL,,,,2024-04-19,2024-09-23,ACTUAL,2023-02-23,ACTUAL,2023-02-23,2024-04,2024-04-30,2023-05-22,ACTUAL,2023-05-22,2023-04-24,ACTUAL,2023-04-24,,INTERVENTIONAL,,Baseline participants included all participants enrolled and who took at least 1 dose of study intervention.,A Study to Understand the Effect of Itraconazole on the Levels of a Study Medicine Called ARV-471 in Healthy Adults,"AN INTERVENTIONAL, PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSES OF ITRACONAZOLE ON THE PHARMACOKINETICS OF SINGLE DOSE ARV-471 IN THE FED CONDITION IN HEALTHY ADULT MALES, AND FEMALES OF NONCHILDBEARING POTENTIAL",COMPLETED,,PHASE1,12.0,ACTUAL,Pfizer,"AUCinf for ARV-473 could only be reported for 2 of 12 participants in Period 1 (ARV-471 alone) and 6 of 12 participants in Period 2 (ARV-471 + itraconazole) based on protocol prespecified criteria, therefore was not used as the primary endpoint for ARV-473. Furthermore, AUC120, was selected as the primary endpoint for ARV-473 in lieu of AUClast to account for the difference in sampling intervals between Test Treatment (0-168 hours) and Reference Treatment (0-120 hours).",1.0,,,f,,,,,f,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,INDUSTRY,,,,,,,2023,1.0
NCT03100006,,2017-03-21,,,2022-06-10,2017-03-28,2017-04-04,ACTUAL,,,,,,,2022-06-10,2022-06-13,ACTUAL,2017-02-22,ACTUAL,2017-02-22,2022-06,2022-06-30,2020-04-17,ACTUAL,2020-04-17,2019-06-07,ACTUAL,2019-06-07,,INTERVENTIONAL,ORION-01,,"Phase Ib/IIa Trial to Evaluate Oregovomab and Nivolumab in Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin","A Phase Ib/IIa Clinical Trial to Evaluate the Safety and Activity of Oregovomab and Nivolumab as a Combinatorial Immunotherapy Strategy in Patients With Recurrent Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin",TERMINATED,,PHASE1/PHASE2,13.0,ACTUAL,"National Cancer Centre, Singapore",,1.0,,The study had poor efficacy.,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,OTHER,,,,,,,2020,0.0
NCT05917470,,2023-06-07,,,2024-09-19,2023-06-15,2023-06-23,ACTUAL,,,,,,,2024-09-19,2024-09-23,ACTUAL,2023-09-20,ACTUAL,2023-09-20,2024-09,2024-09-30,2024-09-12,ACTUAL,2024-09-12,2024-09-12,ACTUAL,2024-09-12,,INTERVENTIONAL,,,A Clinical Study of ONCT-534 in Subjects with Metastatic Castration-resistant Prostate Cancer.,A Phase 1/2 Study of ONCT-534 in Subjects with Metastatic Castration-Resistant Prostate Cancer,TERMINATED,,PHASE1/PHASE2,21.0,ACTUAL,"Oncternal Therapeutics, Inc",,8.0,,"Interim Phase 1 results of ONCT-534 did not show clinically meaningful improvements of disease, including prostate-specific antigen (PSA) levels, in the 20 patients treated in eight dosing cohorts with various doses and schedules of administration.",f,,,,f,t,f,,,f,,,,,,UNDECIDED,,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,INDUSTRY,,,,,,,2024,0.0
NCT04274933,,2020-02-17,,,2020-10-28,2020-02-17,2020-02-18,ACTUAL,,,,,,,2020-10-28,2020-10-29,ACTUAL,2020-05-21,ACTUAL,2020-05-21,2020-10,2020-10-31,2020-10-08,ACTUAL,2020-10-08,2020-10-08,ACTUAL,2020-10-08,,INTERVENTIONAL,,,"A Study to Evaluate the Safety and Tolerability of Venetoclax Tablets in Combination With Capecitabine Tablets in Adult Participants With Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Had Disease Progression During or After CDK4/6 Inhibitor Therapy","A Phase 1b Study of Venetoclax and Capecitabine In Subjects With Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Experienced Disease Progression During or After CDK4/6 Inhibitor Therapy",TERMINATED,,PHASE1,4.0,ACTUAL,AbbVie,,2.0,,Company Decision,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,INDUSTRY,,,,,,,2020,0.0
NCT04231526,,2019-12-20,,,2024-07-29,2020-01-15,2020-01-18,ACTUAL,,,,,,,2024-07-29,2024-07-31,ACTUAL,2020-05-20,ACTUAL,2020-05-20,2024-07,2024-07-31,2022-12-01,ACTUAL,2022-12-01,2022-12-01,ACTUAL,2022-12-01,,INTERVENTIONAL,,,Pembrolizumab in Early Stage Colon Cancer,A Window of Opportunity Study of Pembrolizumab in Colon Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Chicago,,2.0,,unable to accrue,f,,,,f,t,f,,,,,,,,,,,2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,OTHER,,,,,,,2022,0.0
NCT05638334,,2022-10-28,,,2024-09-20,2022-12-05,2022-12-06,ACTUAL,,,,,,,2024-09-20,2024-09-23,ACTUAL,2022-11-21,ACTUAL,2022-11-21,2024-09,2024-09-30,2024-06-14,ACTUAL,2024-06-14,2024-06-14,ACTUAL,2024-06-14,,INTERVENTIONAL,,,Immuno-positron Emission Tomography Study of 89Zr-S095012 in Patients With Advanced Solid Tumours,"An Open Label, Multicentre, Positron Emission Tomography (PET) Imaging Study Using Zirconium-89 to Investigate the Biodistribution and Tumour Uptake of a PD-L1x4-1BB Bispecific Antibody (S095012) in Patients With Advanced Solid Tumours",TERMINATED,,PHASE1,3.0,ACTUAL,Servier,,1.0,,Sponsor decision,f,,,,,f,f,,,,,,After Marketing Authorisation in EEA or US if the study is used for the approval.,Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.,http://clinicaltrials.servier.com/,YES,"Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier.~* with a first patient enrolled as of 1 January 2004 onwards.~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.",2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,INDUSTRY,,,,,,,2024,0.0
NCT03389555,,2017-12-27,2020-11-24,,2021-01-29,2018-01-02,2018-01-03,ACTUAL,2021-01-11,2021-01-29,ACTUAL,,,,2021-01-29,2021-02-16,ACTUAL,2018-02-09,ACTUAL,2018-02-09,2021-01,2021-01-31,2020-02-28,ACTUAL,2020-02-28,2019-11-26,ACTUAL,2019-11-26,,INTERVENTIONAL,,,"Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial","Ascorbic Ccid, Hydrocortisone, and Thiamine in Sepsis and Septic Shock - A Randomized, Double-Blind, Placebo-Controlled Trial",COMPLETED,,PHASE2/PHASE3,205.0,ACTUAL,Beth Israel Deaconess Medical Center,"Ongoing or planned corticosteroid use was the most common exclusion criterion, perhaps eliminating a subset of patients more likely to benefit from corticosteroids. Some patients were discharged alive from the ICU within 96 hours of enrollment; thus, many patients did not receive a full 4 days of study drug",2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,OTHER,,,,,,,2020,1.0
NCT04659369,,2020-11-19,,,2024-04-07,2020-12-02,2020-12-09,ACTUAL,,,,,,,2024-04-07,2024-04-09,ACTUAL,2020-09-24,ACTUAL,2020-09-24,2023-05,2023-05-31,2023-10-16,ACTUAL,2023-10-16,2023-10-16,ACTUAL,2023-10-16,,INTERVENTIONAL,,,"Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC","Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck",TERMINATED,,PHASE1,21.0,ACTUAL,"Taizhou Mabtech Pharmaceutical Co.,Ltd",,2.0,,Difficult to recruit subjects,f,,,,f,f,f,,,t,,,,,,,,2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,INDUSTRY,,,,,,,2023,0.0
NCT03397394,,2017-12-21,2020-07-31,,2023-06-07,2018-01-05,2018-01-12,ACTUAL,2020-10-16,2020-10-19,ACTUAL,,,,2023-06-07,2023-06-09,ACTUAL,2018-06-01,ACTUAL,2018-06-01,2023-06,2023-06-30,2020-01-15,ACTUAL,2020-01-15,2019-12-12,ACTUAL,2019-12-12,,INTERVENTIONAL,ATLAS,,Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma,"A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma",TERMINATED,,PHASE2,97.0,ACTUAL,pharmaand GmbH,The study was terminated early based on an interim analysis by the Data Monitoring Committee that demonstrated that ORR did not meet the protocol-defined continuance criteria. There were no confirmed responses observed.,1.0,,Efficacy did not meet the continuance criteria and DMC recommended to stop enrollment.,f,,,,t,t,f,,,,,,,,,,,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,INDUSTRY,,,,,,,2020,0.0
NCT03995641,,2019-06-20,,,2023-10-09,2019-06-20,2019-06-24,ACTUAL,,,,,,,2023-10-09,2023-10-11,ACTUAL,2019-02-02,ACTUAL,2019-02-02,2023-10,2023-10-31,2023-09-12,ACTUAL,2023-09-12,2023-09-12,ACTUAL,2023-09-12,,INTERVENTIONAL,,,The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation,The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation: A Randomized Trial,TERMINATED,,PHASE4,19.0,ACTUAL,Kettering Health Network,,2.0,,Never received appropriate formulation.,f,,,,,t,f,,,f,,,,,,,,2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,OTHER,,,,,,,2023,0.0
NCT04048707,,2019-07-29,,,2024-03-04,2019-08-05,2019-08-07,ACTUAL,,,,,,,2024-03-04,2024-03-06,ACTUAL,2021-07-01,ESTIMATED,2021-07-01,2024-03,2024-03-31,2023-07-01,ESTIMATED,2023-07-01,2023-06-30,ESTIMATED,2023-06-30,,INTERVENTIONAL,ANTHEM,,Angiotensin 2 for Hepatorenal Syndrome,Angiotensin 2 as a Novel Treatment for Hepatorenal Syndrome,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, Los Angeles",,2.0,,Funding issues; the study was never started,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,OTHER,,,,,,,2023,0.0
NCT05016661,,2021-08-17,,,2024-09-18,2021-08-17,2021-08-23,ACTUAL,,,,,,,2024-09-18,2024-09-20,ACTUAL,2021-10-19,ACTUAL,2021-10-19,2024-09,2024-09-30,2024-08-30,ACTUAL,2024-08-30,2024-07-31,ACTUAL,2024-07-31,,INTERVENTIONAL,,,Extension Study of ABP-20001 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 for Migraine Prevention,"A Randomized, Multicenter, Dose-Blinded, Phase 2 Extension Study of ABP-450 (prabotulinumtoxinA) Purified Neurotoxin Complex for the Prevention of Migraine Headache",TERMINATED,,PHASE2,466.0,ACTUAL,"AEON Biopharma, Inc.",,2.0,,Study was terminated due to the analysis of the data not meeting the intended primary endpoint and key secondary endpoints.,f,,,,f,t,f,,,,,,,,,NO,"Individual Participant Data collected during the trial, after deidentification may be shared following review of the clinical study report by the FDA review division and if a decision is made to publish the results in a publication outside posting the results in clinicaltrials.gov.",2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,INDUSTRY,,,,,,,2024,0.0
NCT03717155,,2018-10-22,2021-09-23,,2022-05-13,2018-10-22,2018-10-24,ACTUAL,2021-11-08,2021-11-09,ACTUAL,,,,2022-05-13,2022-06-06,ACTUAL,2018-10-30,ACTUAL,2018-10-30,2022-04,2022-04-30,2021-05-27,ACTUAL,2021-05-27,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,,,Study of Avelumab and Cetuximab Plus Gemcitabine and Cisplatin in Participants With NSCLC,"A Phase IIa, Single-arm, Multicenter Study to Investigate the Clinical Activity and Safety of Avelumab in Combination With Cetuximab Plus Gemcitabine and Cisplatin in Participants With Advanced Squamous NSCLC",COMPLETED,,PHASE2,43.0,ACTUAL,"Merck KGaA, Darmstadt, Germany",,1.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,INDUSTRY,,,,,,,2021,1.0
NCT05207514,,2022-01-07,,,2024-05-15,2022-01-20,2022-01-26,ACTUAL,,,,,,,2024-05-15,2024-05-17,ACTUAL,2022-03-31,ACTUAL,2022-03-31,2023-05,2023-05-31,2024-05-09,ACTUAL,2024-05-09,2024-02-07,ACTUAL,2024-02-07,,INTERVENTIONAL,,,Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer,"Open-label, Randomized, Active-controlled, Multicenter, Phase III Clinical Trial to Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer",TERMINATED,,PHASE3,26.0,ACTUAL,Samyang Biopharmaceuticals Corporation,,2.0,,The Decision to Terminate Early Due to Difficulties in Recruiting Participants and Conducting the Study.,f,,,,,f,f,,,,,,,,,,,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,INDUSTRY,,,,,,,2024,0.0
NCT03974854,,2019-06-03,,,2024-02-06,2019-06-03,2019-06-05,ACTUAL,,,,,,,2024-02-06,2024-02-07,ACTUAL,2019-07-08,ACTUAL,2019-07-08,2024-01,2024-01-31,2024-02-01,ACTUAL,2024-02-01,2023-08-01,ACTUAL,2023-08-01,,INTERVENTIONAL,ALIX,,Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Advanced Pancreatic Adenocarcinoma,Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Advanced Pancreatic Adenocarcinoma (ALIX),TERMINATED,,PHASE2,25.0,ACTUAL,Centre Hospitalier Universitaire de Besancon,,2.0,,sponsor decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,OTHER,,,,,,,2024,0.0
NCT04737161,,2021-02-01,,,2021-04-14,2021-02-02,2021-02-03,ACTUAL,,,,,,,2021-04-14,2021-04-19,ACTUAL,2021-03,ESTIMATED,2021-03-31,2021-04,2021-04-30,2022-09,ESTIMATED,2022-09-30,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,Safety of T Regulatory Cell Therapy in Subjects With COVID-19 Induced Acute Respiratory Distress Syndrome,A Phase 1 Study to Assess the Safety of Living Related Donor Derived T Regulatory Cell Therapy in Subjects With COVID 19 Induced Acute Respiratory Distress Syndrome (ARDS),WITHDRAWN,,PHASE1,0.0,ACTUAL,Stanford University,,1.0,,Funding not secured,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,OTHER,,,,,,,2022,0.0
NCT03722186,,2018-10-25,,,2021-03-18,2018-10-25,2018-10-26,ACTUAL,,,,,,,2021-03-18,2021-03-22,ACTUAL,2018-11-13,ACTUAL,2018-11-13,2021-03,2021-03-31,2021-10,ESTIMATED,2021-10-31,2019-04-04,ACTUAL,2019-04-04,,INTERVENTIONAL,,,"Safety, Tolerability and Pharmacokinetics/Pharmacodynamics (PK/PD) of SHR-1603 in Subjects With Advanced Malignancies","An Open-label, Single-arm, Phase I Study of the Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of SHR-1603 in Subjects With Advanced Solid Tumor or Relapsed/Refractory Lymphoma",SUSPENDED,,PHASE1,128.0,ESTIMATED,"Jiangsu HengRui Medicine Co., Ltd.",,1.0,,Business Decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,INDUSTRY,,,,,,,2021,0.0
NCT02209545,,2014-07-23,2023-07-12,,2023-08-12,2014-08-04,2014-08-06,ESTIMATED,2023-08-12,2023-09-07,ACTUAL,,,,2023-08-12,2023-09-07,ACTUAL,2014-10,,2014-10-31,2023-08,2023-08-31,2022-07,ACTUAL,2022-07-31,2022-07,ACTUAL,2022-07-31,,INTERVENTIONAL,,,Misoprostol for Reduction of Blood Loss During Fibroid Surgery,Buccal Misoprostol Prior to Abdominal Myomectomy for Reduction of Intraoperative Blood Loss: A Randomized Placebo-Controlled Trial,TERMINATED,,PHASE4,47.0,ACTUAL,Northwestern University,,2.0,,The study was prematurely closed due to low enrollment rates.,f,,,,f,,,,,,,,,,,NO,,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,OTHER,,,,,,,2022,0.0
NCT05182840,,2022-01-05,2024-06-18,,2024-08-05,2022-01-05,2022-01-10,ACTUAL,2024-08-05,2024-08-29,ACTUAL,,,,2024-08-05,2024-08-29,ACTUAL,2022-01-11,ACTUAL,2022-01-11,2024-08,2024-08-31,2023-07-10,ACTUAL,2023-07-10,2023-06-19,ACTUAL,2023-06-19,,INTERVENTIONAL,,"Randomised Set (RS): This patient set included all entered and randomised patients based on the treatment groups they were randomised to at the randomisation prior to the treatment period (i.e. at second randomisation (R2)), regardless of being treated by BI 690517 or not.",A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease,"Randomised, Double-blind, Placebo-controlled and Parallel Dose Group Trial to Investigate Efficacy and Safety of Multiple Doses of Oral BI 690517 Over 14 Weeks, Alone and in Combination With Empagliflozin, in Patients With Diabetic and Non-diabetic Chronic Kidney Disease",COMPLETED,,PHASE2,714.0,ACTUAL,Boehringer Ingelheim,,10.0,,,f,,,,t,t,f,,,,,,"After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.",https://www.mystudywindow.com/msw/datasharing,YES,"Once the time frame criteria given under number 4 are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.",2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,INDUSTRY,,,,,,,2023,1.0
NCT02128958,,2014-04-27,2021-08-04,,2022-09-26,2014-04-30,2014-05-01,ESTIMATED,2021-11-30,2021-12-29,ACTUAL,,,,2022-09-26,2022-10-04,ACTUAL,2014-09,ACTUAL,2014-09-30,2022-09,2022-09-30,2021-12-31,ACTUAL,2021-12-31,2017-11-27,ACTUAL,2017-11-27,,INTERVENTIONAL,,,"Phase 2, Randomized, Double-Blind, Placebo-Controlled of the Efficacy and Safety of CF102 in Hepatocellular Carcinoma (HCC)",A Phase 2 Study in the Second-Line Treatment of Advanced Hepatocellular Carcinoma in Subjects With Child-Pugh Class B Cirrhosis,COMPLETED,,PHASE2,78.0,ACTUAL,Can-Fite BioPharma,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,INDUSTRY,,,,,,,2021,1.0
NCT04118036,,2019-10-04,,,2021-12-13,2019-10-04,2019-10-07,ACTUAL,,,,,,,2021-12-13,2021-12-14,ACTUAL,2021-12-01,ESTIMATED,2021-12-01,2021-12,2021-12-31,2024-12-01,ESTIMATED,2024-12-01,2023-12-01,ESTIMATED,2023-12-01,,INTERVENTIONAL,,,Abemaciclib + Pembrolizumab In Glioblastoma,A Phase 2 Study of Abemaciclib and Pembrolizumab in Recurrent Glioblastoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,Dana-Farber Cancer Institute,,2.0,,Safety concerns,f,,,,t,t,f,,,t,,,Data can be shared no earlier than 1 year following the date of publication,Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,OTHER,,,,,,,2024,0.0
NCT05001724,,2021-07-16,,,2023-04-23,2021-08-03,2021-08-12,ACTUAL,,,,,,,2023-04-23,2023-04-25,ACTUAL,2021-10-28,ACTUAL,2021-10-28,2023-04,2023-04-30,2023-04-07,ACTUAL,2023-04-07,2023-02-13,ACTUAL,2023-02-13,,INTERVENTIONAL,,,KN046 Plus Lenvatinib in Subject With Advanced Non-Small Cell Lung Cancer in the Failure of Anti-PD-(L)1 Agent,"A Randomized, Open-Label, Active-Controlled, Multi-Center Study to Compare Efficacy, Safety, and Tolerability of KN046 Combined With Lenvatinib Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer After Failure of Anti-PD-(L)1 Agent",TERMINATED,,PHASE2/PHASE3,16.0,ACTUAL,"Jiangsu Alphamab Biopharmaceuticals Co., Ltd",,2.0,,"Because the efficacy data did not meet expectations, the sponsor decided to terminate the study.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,INDUSTRY,,,,,,,2023,0.0
NCT01977417,,2013-10-30,2023-07-06,,2023-09-04,2013-11-05,2013-11-06,ESTIMATED,2023-09-04,2023-09-11,ACTUAL,,,,2023-09-04,2023-09-11,ACTUAL,2012-11,ACTUAL,2012-11-30,2023-09,2023-09-30,2021-04,ACTUAL,2021-04-30,2021-04,ACTUAL,2021-04-30,,INTERVENTIONAL,INCITE,,Inflammation Inhibition in Prediabetic Humans,Inflammation Inhibition for Microvascular and Autonomic Dysfunction in Obese Prediabetic Humans,TERMINATED,,PHASE2,21.0,ACTUAL,University of Iowa,,2.0,,No funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,OTHER,,,,,,,2021,0.0
NCT04650204,,2020-11-11,2023-05-27,,2023-05-27,2020-11-30,2020-12-02,ACTUAL,2023-05-27,2023-06-22,ACTUAL,,,,2023-05-27,2023-06-22,ACTUAL,2020-12-04,ACTUAL,2020-12-04,2023-05,2023-05-31,2023-04-30,ACTUAL,2023-04-30,2023-04-30,ACTUAL,2023-04-30,,INTERVENTIONAL,,,Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy,"A Phase IV, Prospective, Open-Label, Parallel Study Evaluating the Effect of an Adjunctive Anti-Seizure Medication Using a Glutamatergic Modulator in Patients With Focal Epilepsy and High-Grade Glioma",TERMINATED,,PHASE4,4.0,ACTUAL,Mayo Clinic,Study was terminated due to the funding sponsor(EISAI) sold the US rights to the medication and can no longer provide it to patients for the study.,2.0,,"The funding sponsor, EISAI, sold the US rights to the medication and can no longer provide it to patients for the study.",f,,,,f,t,f,,,,,,,,,,,2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,OTHER,,,,,,,2023,0.0
NCT03236506,,2017-07-04,2021-08-24,,2021-10-25,2017-07-27,2017-08-02,ACTUAL,2021-10-25,2021-11-18,ACTUAL,,,,2021-10-25,2021-11-18,ACTUAL,2018-01-19,ACTUAL,2018-01-19,2021-10,2021-10-31,2020-10-28,ACTUAL,2020-10-28,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,ADVANCE,,A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study,A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study,COMPLETED,,PHASE2,129.0,ACTUAL,University of Dundee,,3.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,OTHER,,,,,,,2020,1.0
NCT04219319,,2019-11-20,,,2022-08-12,2020-01-03,2020-01-07,ACTUAL,,,,,,,2022-08-12,2022-08-16,ACTUAL,2021-12-15,ACTUAL,2021-12-15,2022-08,2022-08-31,2022-07-20,ACTUAL,2022-07-20,2022-07-20,ACTUAL,2022-07-20,,INTERVENTIONAL,,,LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T-cell Lymphoma,"A Phase I, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T Lymphocyte Tumor Patiens",TERMINATED,,PHASE1,4.0,ACTUAL,The First Affiliated Hospital with Nanjing Medical University,,1.0,,Both the sponsors and collaborator are considering terminating the study,f,,,,,f,f,,,,,,,,,,,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,OTHER,,,,,,,2022,0.0
NCT04074161,,2019-08-28,2022-03-21,,2023-05-18,2019-08-28,2019-08-29,ACTUAL,2022-04-26,2022-04-27,ACTUAL,,,,2023-05-18,2023-05-19,ACTUAL,2019-09-11,ACTUAL,2019-09-11,2023-05,2023-05-31,2021-05-11,ACTUAL,2021-05-11,2021-03-27,ACTUAL,2021-03-27,,INTERVENTIONAL,STEP 8,The full analysis set (FAS) included all randomized participants.,Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity,Effect and Safety of Subcutaneous Semaglutide 2.4 mg Once Weekly Compared to Liraglutide 3.0 mg Once Daily on Weight Management in Subjects With Overweight or Obesity,COMPLETED,,PHASE3,338.0,ACTUAL,Novo Nordisk A/S,,4.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,INDUSTRY,,,,,,,2021,1.0
NCT04653038,,2020-11-16,,,2024-01-25,2020-11-26,2020-12-04,ACTUAL,,,,,,,2024-01-25,2024-01-29,ACTUAL,2020-10-29,ACTUAL,2020-10-29,2024-01,2024-01-31,2022-03-02,ACTUAL,2022-03-02,2022-03-02,ACTUAL,2022-03-02,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Efficacy of MGD013 in Patients With Melanoma,"An Open-label, Multi-cohort, Multi-center Phase I Study Evaluating the Efficacy and Safety of MGD013 in Patients With Unresectable, Recurrent or Metastatic Malignant Melanoma",TERMINATED,,PHASE1,92.0,ACTUAL,"Zai Lab (Hong Kong), Ltd.",,2.0,,rapid changes in the treatment mode of melanoma worldwide and in China and the development strategy change,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,INDUSTRY,,,,,,,2022,0.0
NCT03605836,,2018-06-28,2021-05-10,,2021-09-20,2018-07-26,2018-07-30,ACTUAL,2021-09-20,2021-10-18,ACTUAL,,,,2021-09-20,2021-10-18,ACTUAL,2019-01-16,ACTUAL,2019-01-16,2021-09,2021-09-30,2020-05-14,ACTUAL,2020-05-14,2020-05-14,ACTUAL,2020-05-14,,INTERVENTIONAL,,Participants who participated only in the Run-in Period and Full Analysis Set (FAS) of the Double-blind Treatment Period including all participants of the safety sample of Double-blind Treatment Period who had a Baseline value and at least one valid post-randomization efficacy evaluation for adult ADHD investigator symptom rating scale (AISRS) total score in the Double-blind Treatment Period.,"A Trial to Evaluate the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder","A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder",COMPLETED,,PHASE3,590.0,ACTUAL,"Otsuka Pharmaceutical Development & Commercialization, Inc.",,4.0,,,f,,,,,t,f,,,,,,"Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.",Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/,https://clinical-trials.otsuka.com,YES,Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,INDUSTRY,,,,,,,2020,1.0
NCT03788343,,2018-12-17,,,2023-03-06,2018-12-21,2018-12-27,ACTUAL,,,,,,,2023-03-06,2023-03-07,ACTUAL,2019-08-19,ACTUAL,2019-08-19,2023-03,2023-03-31,2022-06-17,ACTUAL,2022-06-17,2022-06-17,ACTUAL,2022-06-17,,INTERVENTIONAL,PICO,,Phenylalanine and Its Impact on Cognition,"PICO: Phenylalanine and Its Impact on Cognition - Impact of Phenylalanine on Cognitive, Cerebral and Neurometabolic Parameters in Adult Patients With Phenylketonuria",COMPLETED,,PHASE4,90.0,ACTUAL,"Insel Gruppe AG, University Hospital Bern",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 20:40:40.726513,2024-10-16 20:40:40.726513,OTHER,,,,,,,2022,1.0
NCT02982694,,2016-12-01,,,2021-10-04,2016-12-02,2016-12-05,ESTIMATED,,,,,,,2021-10-04,2021-10-12,ACTUAL,2017-11-24,ACTUAL,2017-11-24,2020-10,2020-10-31,2020-11-27,ACTUAL,2020-11-27,2020-11-27,ACTUAL,2020-11-27,,INTERVENTIONAL,,,"Study With Atezolizumab Plus Bevacizumab in Patients With Chemotherapy Resistant, MSI-like, Colorectal Cancer",A Phase II Open-label Study With the Anti-PD-L1 Atezolizumab Monoclonal Antibody in Combination With Bevacizumab in Patients With Advanced Chemotherapy Resistant Colorectal Cancer and MSI-like Molecular Signature,TERMINATED,,PHASE2,46.0,ACTUAL,Vall d'Hebron Institute of Oncology,,1.0,,"The results of the interim analysis showed that the efficacy in the MSS subgroup (MSI like) is inferior to the expected, and this situation is very unlikely to be reversed if the trial is fully completed.",f,,,,t,f,f,,,,,,,,,,,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,OTHER,,,,,,,2020,0.0
NCT04546581,,2020-09-08,2022-03-28,,2022-03-31,2020-09-08,2020-09-14,ACTUAL,2022-03-31,2022-04-04,ACTUAL,,,,2022-03-31,2022-04-04,ACTUAL,2020-10-08,ACTUAL,2020-10-08,2022-03,2022-03-31,2021-05-21,ACTUAL,2021-05-21,2021-05-21,ACTUAL,2021-05-21,,INTERVENTIONAL,,,Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC),"An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19",COMPLETED,,PHASE3,593.0,ACTUAL,University of Minnesota,,2.0,,,f,,,,t,t,f,,,t,,,,,,YES,A public data set will be made available at the end of the trial,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,OTHER,,,,,,,2021,0.0
NCT04051203,,2019-07-23,,,2024-02-02,2019-08-08,2019-08-09,ACTUAL,,,,,,,2024-02-02,2024-02-06,ACTUAL,2019-02-01,ACTUAL,2019-02-01,2023-10,2023-10-31,2023-12-01,ACTUAL,2023-12-01,2023-12-01,ACTUAL,2023-12-01,,INTERVENTIONAL,,,Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia,Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia: A Randomized Controlled Pilot Study,COMPLETED,,PHASE1,35.0,ACTUAL,University of Calgary,,3.0,,,f,,,,t,f,f,,,,,,,,,NO,"There is no plan, all participant data will be kept on a secured REDCap database.",2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,OTHER,,,,,,,2023,1.0
NCT04431466,,2020-06-10,,,2021-10-07,2020-06-11,2020-06-16,ACTUAL,,,,,,,2021-10-07,2021-10-12,ACTUAL,2020-07-01,ACTUAL,2020-07-01,2021-10,2021-10-31,2020-12-01,ACTUAL,2020-12-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,IFORS,,A Study to Compare the Efficacy and Safety of Different Doses of Ivermectin for COVID-19,Phase 2 Clinical Trial to Compare the Efficacy and Safety of Different Doses of Ivermectin in Patients Diagnosed With the New Coronavirus Infection (SARS-CoV-2),TERMINATED,,PHASE2,32.0,ACTUAL,Universidade Federal de Sao Carlos,,4.0,,"Preliminary data from a pilot study suggest that the administration of ivermectin in patients with SARS-CoV-2 is safe, reducing symptoms and viral load. The antiviral effects of ivermectin appear to depend on the dose administered.",f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,OTHER,,,,,,,2020,0.0
NCT04738292,,2021-02-01,2024-02-14,,2024-05-01,2021-02-01,2021-02-04,ACTUAL,2024-05-01,2024-05-03,ACTUAL,,,,2024-05-01,2024-05-03,ACTUAL,2021-10-05,ACTUAL,2021-10-05,2024-05,2024-05-31,2023-05-15,ACTUAL,2023-05-15,2023-04-03,ACTUAL,2023-04-03,,INTERVENTIONAL,,,Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study),"A Phase II Trial of OnapriStone in CoMbInation With FuLvestrant for Patients With ER-positive, and HER2-negative Metastatic Breast Cancer After Progression on Endocrine Therapy and CDK 4/6 Inhibitors",TERMINATED,,PHASE2,11.0,ACTUAL,"University of Wisconsin, Madison","Study was terminated early, sponsor closed study. Study not powered per protocol.",1.0,,funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,OTHER,,,,,,,2023,0.0
NCT04395105,,2020-05-16,,,2021-05-28,2020-05-18,2020-05-20,ACTUAL,,,,,,,2021-05-28,2021-06-02,ACTUAL,2020-05-21,ACTUAL,2020-05-21,2021-05,2021-05-31,2021-05-21,ACTUAL,2021-05-21,2021-04-05,ACTUAL,2021-04-05,,INTERVENTIONAL,,,"Dexamethasone for COVID-19 Related ARDS: a Multicenter, Randomized Clinical Trial",High Versus Low Dose Dexamethasone for the Treatment of COVID-19 Related ARDS: a Multicenter and Randomized Open-label Clinical Trial,TERMINATED,,PHASE3,100.0,ACTUAL,Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno,,2.0,,Low rate of recruitment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,OTHER,,,,,,,2021,0.0
NCT06087731,,2023-09-22,,,2023-11-23,2023-10-11,2023-10-18,ACTUAL,,,,,,,2023-11-23,2023-11-28,ACTUAL,2023-09-23,ACTUAL,2023-09-23,2023-04,2023-04-30,2023-09-23,ACTUAL,2023-09-23,2023-09-23,ACTUAL,2023-09-23,,INTERVENTIONAL,,,Efficacy and Safety of Tocilizumab for TAO,Efficacy and Safety of Tocilizumab for Patients With Thyroid-associated Ophthalmopathy,WITHDRAWN,,PHASE2,0.0,ACTUAL,Sun Yat-sen University,,1.0,,For some personal reasons.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,OTHER,,,,,,,2023,0.0
NCT04811131,,2021-03-18,2024-06-14,2022-06-29,2024-07-11,2021-03-19,2021-03-23,ACTUAL,2024-07-11,2024-07-12,ACTUAL,,2024-07-12,ACTUAL,2024-07-11,2024-07-12,ACTUAL,2021-03-04,ACTUAL,2021-03-04,2024-07,2024-07-31,2021-08-09,ACTUAL,2021-08-09,2021-08-09,ACTUAL,2021-08-09,,INTERVENTIONAL,,The Baseline Analysis Population is based on all treated participants.,Safety and Efficacy of ARQ-252 Cream 0.3% in Subjects With Non-Segmental Facial Vitiligo,"A Phase 2a, Proof of Concept, 24-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-252 Cream 0.3% in Subjects With Non-Segmental Facial Vitiligo",TERMINATED,,PHASE2,114.0,ACTUAL,"Arcutis Biotherapeutics, Inc.",,4.0,,Sponsor Decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,INDUSTRY,,,,,,,2021,0.0
NCT04982575,,2021-07-16,2023-07-06,,2024-06-28,2021-07-28,2021-07-29,ACTUAL,2023-07-06,2023-07-27,ACTUAL,,,,2024-06-28,2024-07-01,ACTUAL,2021-08-02,ACTUAL,2021-08-02,2024-06,2024-06-30,2022-07-07,ACTUAL,2022-07-07,2022-07-07,ACTUAL,2022-07-07,,INTERVENTIONAL,,Full analyis set (FAS) included all randomized participants.,Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes,Efficacy and Safety of Co-administration of Cagrilintide s.c. 2.4 mg and Semaglutide s.c. 2.4 mg Once Weekly in Subjects With Type 2 Diabetes,COMPLETED,,PHASE2,92.0,ACTUAL,Novo Nordisk A/S,,3.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,INDUSTRY,,,,,,,2022,1.0
NCT04810208,,2021-03-18,,,2021-12-22,2021-03-19,2021-03-22,ACTUAL,,,,,,,2021-12-22,2021-12-30,ACTUAL,2019-02-28,ACTUAL,2019-02-28,2021-12,2021-12-31,2021-10-07,ACTUAL,2021-10-07,2021-10-07,ACTUAL,2021-10-07,,INTERVENTIONAL,,,Intratumoural Injection of a Novel NanoZolid®-Docetaxel Depot Formulation in Patients With Advanced Solid Tumours,"A Phase Ia/Ib, First-in-human, Open Label, Multicentre, Dose-escalation and Dose-expansion Study of a Novel NanoZolid®-Docetaxel Depot Formulation (NZ-DTX Depot) Given as an Intra-tumoural Injection in Patients With Advanced Solid Tumours",TERMINATED,,PHASE1,6.0,ACTUAL,Lidds AB,,1.0,,Strategic decision,f,,,,t,f,f,,,,,,,,,,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,INDUSTRY,,,,,,,2021,0.0
NCT02867813,,2016-07-20,2023-02-02,,2023-04-05,2016-08-11,2016-08-16,ESTIMATED,2023-02-02,2023-02-28,ACTUAL,,,,2023-04-05,2023-04-07,ACTUAL,2016-09-02,ACTUAL,2016-09-02,2023-03,2023-03-31,2022-03-21,ACTUAL,2022-03-21,2022-03-21,ACTUAL,2022-03-21,,INTERVENTIONAL,FOURIER OLE,The Overall Number of Baseline Participants is made up of all of the participants that received study drug.,Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension,"A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Patients With Clinically Evident Cardiovascular Disease",COMPLETED,,PHASE3,5035.0,ACTUAL,Amgen,,1.0,,,f,,,,f,,,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,INDUSTRY,,,,,,,2022,1.0
NCT02514239,,2015-05-21,2021-06-29,,2022-02-10,2015-07-31,2015-08-03,ESTIMATED,2021-06-29,2021-07-22,ACTUAL,,,,2022-02-10,2022-02-24,ACTUAL,2015-07-08,ACTUAL,2015-07-08,2022-02,2022-02-28,2020-07-02,ACTUAL,2020-07-02,2018-07-17,ACTUAL,2018-07-17,,INTERVENTIONAL,,Treated set (TS): all patients who were administered trial medication.,Phase I Dose Escalation of i.v. BI 836909 Monotherapy in Last Line Multiple Myeloma Patients,"An Open Label, Phase I, Dose Escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Doses of BI 836909 in Relapsed and/or Refractory Multiple Myeloma Patients",COMPLETED,,PHASE1,43.0,ACTUAL,Boehringer Ingelheim,,13.0,,,f,,,,,,,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datatransparency",2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,INDUSTRY,,,,,,,2020,1.0
NCT02765997,,2016-05-05,,,2017-12-03,2016-05-05,2016-05-09,ESTIMATED,,,,,,,2017-12-03,2017-12-05,ACTUAL,2017-04,ESTIMATED,2017-04-30,2017-12,2017-12-31,2022-06,ESTIMATED,2022-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,StemRegenin-1 Expanded vs Unexpanded UCB for High Risk Heme Malignancies,"Single-Center, Open Label, Randomized Trial Comparing StemRegenin-1 Expanded Versus Unmanipulated Umbilical Cord Blood Transplantation In Patients With High-Risk Malignancy",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Masonic Cancer Center, University of Minnesota",,2.0,,IRB Disapproval,f,,,,,t,f,,,f,,,,,,,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,OTHER,,,,,,,2022,0.0
NCT01131169,,2010-05-25,2021-04-08,,2021-11-04,2010-05-25,2010-05-26,ESTIMATED,2021-11-04,2021-12-02,ACTUAL,,,,2021-11-04,2021-12-02,ACTUAL,2010-05,ACTUAL,2010-05-31,2019-06,2019-06-30,2020-05-15,ACTUAL,2020-05-15,2020-05-15,ACTUAL,2020-05-15,,INTERVENTIONAL,,,"Busulfan, Melphalan, Fludarabine and T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Followed by Post Transplantation Donor Lymphocyte Infusions","A Trial of Busulfan, Melphalan, Fludarabine and T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Followed by Post Transplantation Donor Lymphocyte Infusions for Patients With Relapsed or High-Risk Multiple Myeloma",COMPLETED,,PHASE2,66.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,OTHER,,,,,,,2020,1.0
NCT03866577,,2019-02-12,2024-06-03,2022-06-06,2024-06-03,2019-03-05,2019-03-07,ACTUAL,2024-06-03,2024-07-01,ACTUAL,2022-06-06,2022-06-08,ACTUAL,2024-06-03,2024-07-01,ACTUAL,2018-12-21,ACTUAL,2018-12-21,2024-05,2024-05-31,2021-06-09,ACTUAL,2021-06-09,2021-06-09,ACTUAL,2021-06-09,,INTERVENTIONAL,,,Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients,"A 4-part Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of M254 in Healthy Volunteers and in Patients With Immune Thrombocytopenic Purpura",TERMINATED,,PHASE1/PHASE2,50.0,ACTUAL,"Momenta Pharmaceuticals, Inc.","Part C (Group 2) and Part D were planned but not conducted based on sponsor decision to discontinue the study after completion of Part A, Part B, and Part C (Group 1). No safety concerns were identified and study was terminated for business reasons.",4.0,,Study was terminated based on Sponsor decision.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,INDUSTRY,,,,,,,2021,0.0
NCT02060305,,2014-02-05,,,2021-07-02,2014-02-07,2014-02-12,ESTIMATED,,,,,,,2021-07-02,2021-07-06,ACTUAL,2014-02-01,,2014-02-01,2021-07,2021-07-31,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,Intra-articular Bevacizumab for Recurrent Hemarthroses at Target Joints With Chronic Hemophilic Synovitis,A Pilot Study About the Safety and Efficacy of Intra-articular Bevacizumab (Avastin) for Recurrent Hemarthroses at Target Joints With Chronic Hemophilic Synovitis,TERMINATED,,PHASE1,5.0,ACTUAL,National Taiwan University Hospital,,1.0,,Very slow enrollment,f,,,,t,,,,,,,,,,,,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,OTHER,,,,,,,2020,0.0
NCT04396106,,2020-05-16,2023-01-04,,2023-02-08,2020-05-19,2020-05-20,ACTUAL,2023-02-08,2023-03-09,ACTUAL,,,,2023-02-08,2023-03-09,ACTUAL,2020-05-26,ACTUAL,2020-05-26,2023-02,2023-02-28,2022-02-28,ACTUAL,2022-02-28,2022-01-10,ACTUAL,2022-01-10,,INTERVENTIONAL,,Intent-to-treat,Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-527 in Subjects With Moderate COVID-19",TERMINATED,,PHASE2,83.0,ACTUAL,"Atea Pharmaceuticals, Inc.","Study was prematurely discontinued. At the time of study discontinuation, only 2 subjects were enrolled in Part B and both received placebo.",4.0,,Study closed out early due to evolving COVID-19 standard of care,f,,,,,t,f,,,,,,,,,,,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,INDUSTRY,,,,,,,2022,0.0
NCT03590210,,2018-06-21,,,2022-11-07,2018-07-05,2018-07-18,ACTUAL,,,,,,,2022-11-07,2022-11-08,ACTUAL,2018-06-08,ACTUAL,2018-06-08,2022-11,2022-11-30,2022-02-12,ACTUAL,2022-02-12,2022-02-12,ACTUAL,2022-02-12,,INTERVENTIONAL,NiTraSarc,,Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas,NiTraSarc Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas - The NiTraSarc Phase II Trial,COMPLETED,,PHASE2,92.0,ACTUAL,University Medicine Greifswald,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,OTHER,,,,,,,2022,1.0
NCT03730402,,2018-11-02,,,2021-06-28,2018-11-02,2018-11-05,ACTUAL,,,,,,,2021-06-28,2021-07-01,ACTUAL,2019-02-04,ACTUAL,2019-02-04,2021-06,2021-06-30,2021-04-14,ACTUAL,2021-04-14,2021-04-14,ACTUAL,2021-04-14,,INTERVENTIONAL,,,Laparoscopic Assisted Plane Block (LAPB) Trial,Laparoscopic Assisted Plane Block (LAPB) Trial: Bupivacaine Versus Liposomal Bupivacaine Versus Standard Local Anesthesia for Post-operative Analgesia,TERMINATED,,PHASE4,34.0,ACTUAL,Santa Barbara Cottage Hospital,,3.0,,There were not enough attendings/residents working on the study throughout the COVID-19 pandemic in order to enroll the number of patients required to meet statistical significance.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,OTHER,,,,,,,2021,0.0
NCT02524275,,2015-08-12,2022-08-10,,2023-08-25,2015-08-12,2015-08-14,ESTIMATED,2022-08-10,2022-09-01,ACTUAL,,,,2023-08-25,2023-09-08,ACTUAL,2015-03-30,ACTUAL,2015-03-30,2023-08,2023-08-31,2021-10-28,ACTUAL,2021-10-28,2021-10-28,ACTUAL,2021-10-28,,INTERVENTIONAL,,,Docetaxel and Capecitabine With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck,Phase II Study of Docetaxel and Capecitabine in Advanced Squamous Cell Carcinoma of the Head and Neck,TERMINATED,,PHASE2,14.0,ACTUAL,University of Nebraska,,1.0,,low enrollment,f,,,,t,t,f,,,f,,,,,,,,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,OTHER,,,,,,,2021,0.0
NCT06160609,,2023-11-29,2024-01-09,,2024-02-23,2023-11-29,2023-12-07,ACTUAL,2024-02-23,2024-03-12,ACTUAL,,,,2024-02-23,2024-03-12,ACTUAL,2019-10-07,ACTUAL,2019-10-07,2024-02,2024-02-29,2023-01-09,ACTUAL,2023-01-09,2023-01-09,ACTUAL,2023-01-09,,INTERVENTIONAL,,,Platform Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With aOX40 (GSK3174998) in Participants With RRMM,"A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)-DREAMM5. Sub-study 1 - Belantamab Mafodotin and aOX40 (GSK3174998) in Combination",TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,GlaxoSmithKline,,1.0,,The study was terminated due to lack of efficacy.,t,,,,f,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,INDUSTRY,,NCT03763370,AVAILABLE,,,,2023,0.0
NCT02832687,,2016-05-24,2021-08-31,,2021-11-10,2016-07-11,2016-07-14,ESTIMATED,2021-11-10,2021-12-09,ACTUAL,,,,2021-11-10,2021-12-09,ACTUAL,2017-06-19,ACTUAL,2017-06-19,2021-11,2021-11-30,2020-12-31,ACTUAL,2020-12-31,2020-09-01,ACTUAL,2020-09-01,,INTERVENTIONAL,,A total of 88 patients were enrolled; from 47 who were randomized to receive intravenous acetaminophen 45 completed the study; from 41 received placebo 41 completed. A total of 65 patients were included into analyses with 34 receiving intravenous acetaminophen and 31 receiving placebo.,Multi-dose Acetaminophen for Patients Undergoing General Anesthesia,"A Multi-center, Randomized, Double-blind, Pilot Study on the Effect of Intravenous Multi-dose Acetaminophen on Readiness for Discharge in Patients Undergoing Surgery With General Anesthesia",TERMINATED,,PHASE4,88.0,ACTUAL,"Rutgers, The State University of New Jersey",,2.0,,The study was halted due to the worldwide COVID-19 pandemic and the cancellation of all elective cases.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,OTHER,,,,,,,2020,0.0
NCT03850483,,2019-02-20,2022-04-07,,2022-06-03,2019-02-20,2019-02-21,ACTUAL,2022-06-03,2022-06-29,ACTUAL,,,,2022-06-03,2022-06-29,ACTUAL,2019-04-08,ACTUAL,2019-04-08,2022-06,2022-06-30,2021-04-20,ACTUAL,2021-04-20,2021-04-20,ACTUAL,2021-04-20,,INTERVENTIONAL,,Analysis population included participants who were randomly assigned to PF-06700841 and applied at least 1 dose of PF-06700841.,"Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis","A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL-GROUP, DOSE RANGING STUDY TO ASSESS EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 TOPICAL CREAM APPLIED ONCE OR TWICE DAILY FOR 12 WEEKS IN PARTICIPANTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS",COMPLETED,,PHASE2,344.0,ACTUAL,Pfizer,,9.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,INDUSTRY,,,,,,,2021,1.0
NCT04537078,,2020-08-28,2021-11-01,,2022-01-26,2020-08-28,2020-09-03,ACTUAL,2022-01-26,2022-02-17,ACTUAL,,,,2022-01-26,2022-02-17,ACTUAL,2020-09-01,ACTUAL,2020-09-01,2022-01,2022-01-31,2021-09-01,ACTUAL,2021-09-01,2021-03-01,ACTUAL,2021-03-01,,INTERVENTIONAL,,,Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders,Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders,COMPLETED,,PHASE3,90.0,ACTUAL,El Shatby University Hospital for Obstetrics and Gynecology,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,OTHER,,,,,,,2021,1.0
NCT02570789,,2015-09-17,,,2021-03-18,2015-10-06,2015-10-07,ESTIMATED,,,,,,,2021-03-18,2021-03-23,ACTUAL,2012-12,,2012-12-31,2021-03,2021-03-31,2021-03-01,ACTUAL,2021-03-01,2018-12,ACTUAL,2018-12-31,,INTERVENTIONAL,METASUN,,Evaluation of Predictive Markers for Toxicity and Efficacy in Patients With mccRCC Treated by Anti-VEGF Therapy,A Proof of Concept Study to Evaluate the Use of Metabonomics and Lipidomics in Predicting Toxicity and Efficacy of Anti-VEGF Therapy in Patients With Metastatic Clear Cell Renal Cell Carcinoma,TERMINATED,,PHASE4,90.0,ACTUAL,Cliniques universitaires Saint-Luc- Université Catholique de Louvain,,1.0,,not enough accrual,f,,,,t,,,,,,,,,,,,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,OTHER,,,,,,,2021,0.0
NCT03745989,,2018-11-16,2022-02-25,,2023-07-25,2018-11-16,2018-11-19,ACTUAL,2022-04-21,2023-01-25,ACTUAL,,,,2023-07-25,2023-07-27,ACTUAL,2019-02-22,ACTUAL,2019-02-22,2023-07,2023-07-31,2021-03-19,ACTUAL,2021-03-19,2021-03-19,ACTUAL,2021-03-19,,INTERVENTIONAL,,,Study of MK-8353 + Selumetinib in Advanced/Metastatic Solid Tumors (MK-8353-014),Phase 1b Open-label Study of MK-8353 in Combination With Selumetinib (MK-5618) in Participants With Advanced/Metastatic Solid Tumors,COMPLETED,,PHASE1,30.0,ACTUAL,Merck Sharp & Dohme LLC,,1.0,,,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 10:04:16.813335,2024-10-16 10:04:16.813335,INDUSTRY,,,,,,,2021,1.0
NCT03136497,,2017-04-20,2023-01-27,,2024-06-03,2017-04-27,2017-05-02,ACTUAL,2024-06-03,2024-09-23,ACTUAL,,,,2024-06-03,2024-09-23,ACTUAL,2017-09-05,ACTUAL,2017-09-05,2024-06,2024-06-30,2020-11-09,ACTUAL,2020-11-09,2020-11-09,ACTUAL,2020-11-09,,INTERVENTIONAL,,"10 patients consented, of which 9 were treated and 1 screen failure",A Study of ABT-199 Plus Ibrutinib and Rituximab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma,Phase Ib Dose Finding Study of ABT-199 (A-1195425.0) Plus Ibrutinib (PCI-32765) and Rituximab in Patients With Relapsed/Refractory Diffuse Large B-cell NHL (DLBCL),TERMINATED,,PHASE1,10.0,ACTUAL,Hackensack Meridian Health,,2.0,,Lack of enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,OTHER,,,,,,,2020,0.0
NCT03825783,,2019-01-25,,,2021-11-23,2019-01-29,2019-01-31,ACTUAL,,,,,,,2021-11-23,2021-12-07,ACTUAL,2019-04-15,ACTUAL,2019-04-15,2021-11,2021-11-30,2021-10,ESTIMATED,2021-10-31,2021-10,ESTIMATED,2021-10-31,,INTERVENTIONAL,,,A Gene Therapy Trial to Evaluate the Safety and Efficacy of RP-L201 in Subjects With Leukocyte Adhesion Deficiency-I,Gene Therapy for Leukocyte Adhesion Deficiency-I (LAD-I): A Phase I Clinical Trial to Evaluate the Safety and Efficacy of the Infusion of Autologous Hematopoietic Stem Cells Transduced With a Lentiviral Vector Encoding the ITGB2 Gene.,WITHDRAWN,,PHASE1,0.0,ACTUAL,Rocket Pharmaceuticals Inc.,,1.0,,Patients were enrolled under global Phase 1/2 protocol RP-L201-0318.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,INDUSTRY,,,,,,,2021,0.0
NCT03057990,,2016-11-30,,,2021-09-15,2017-02-15,2017-02-20,ACTUAL,,,,,,,2021-09-15,2021-09-22,ACTUAL,2019-09-11,ACTUAL,2019-09-11,2021-09,2021-09-30,2021-06-29,ACTUAL,2021-06-29,2021-06-29,ACTUAL,2021-06-29,,INTERVENTIONAL,,,Pyrimethamine for Intermediate/High-risk Myelodysplastic Syndromes (MDS),"A Phase 1 Study of Pyrimethamine, a STAT3 Inhibitor, for the Treatment of Intermediate/ High-risk Myelodysplastic Syndromes (MDS) That Has Relapsed or is Refractory to Azanucleosides",WITHDRAWN,,PHASE1,0.0,ACTUAL,Montefiore Medical Center,,1.0,,Study never opened; closed on 06/29/2021 due to no enrllment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,OTHER,,,,,,,2021,0.0
NCT04028349,,2019-07-03,,,2021-05-10,2019-07-19,2019-07-22,ACTUAL,,,,,,,2021-05-10,2021-05-12,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2021-05,2021-05-31,2021-03-19,ACTUAL,2021-03-19,2021-03-19,ACTUAL,2021-03-19,,INTERVENTIONAL,,,"ZEBOVAC (Ebola Vaccine Trial, Ad26.ZEBOV/MVA-BN-Filo)","An Open-label, Single Arm Study to Provide Additional Information on Immunogenicity and Safety of Ad26.ZEBOV/MVA-BN-Filo",COMPLETED,,PHASE2,800.0,ACTUAL,MRC/UVRI and LSHTM Uganda Research Unit,,1.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,OTHER,,,,,,,2021,1.0
NCT04447040,,2020-06-23,2024-03-14,2022-04-06,2024-03-14,2020-06-23,2020-06-25,ACTUAL,2024-03-14,2024-04-11,ACTUAL,2022-04-06,2022-04-08,ACTUAL,2024-03-14,2024-04-11,ACTUAL,2020-11-09,ACTUAL,2020-11-09,2024-03,2024-03-31,2021-05-03,ACTUAL,2021-05-03,2021-04-09,ACTUAL,2021-04-09,,INTERVENTIONAL,,,Acetaminophen/Naproxen Sodium Dose Ranging Study,"A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Five Strengths of a Fixed Combination of Acetaminophen/Naproxen Sodium in Postoperative Dental Pain",COMPLETED,,PHASE2,304.0,ACTUAL,Johnson & Johnson Consumer and Personal Products Worldwide,,6.0,,,,,,,f,t,f,,,,,,,,http://yoda.yale.edu.,YES,Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,INDUSTRY,,,,,,,2021,1.0
NCT04900428,,2021-05-20,,,2023-01-26,2021-05-21,2021-05-25,ACTUAL,,,,,,,2023-01-26,2023-01-30,ACTUAL,2021-07-16,ACTUAL,2021-07-16,2023-01,2023-01-31,2022-05-06,ACTUAL,2022-05-06,2022-03-22,ACTUAL,2022-03-22,,INTERVENTIONAL,,,Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (UK),"A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19",TERMINATED,,PHASE2,179.0,ACTUAL,"Sorrento Therapeutics, Inc.",,2.0,,Study was terminated at interim analysis due to drops not working on new variants,f,,,,,t,f,,,,,,,,,,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,INDUSTRY,,,,,,,2022,0.0
NCT03591874,,2018-07-09,2022-06-10,,2022-06-10,2018-07-09,2018-07-19,ACTUAL,2022-06-10,2022-07-06,ACTUAL,,,,2022-06-10,2022-07-06,ACTUAL,2018-12-23,ACTUAL,2018-12-23,2022-06,2022-06-30,2020-04-30,ACTUAL,2020-04-30,2020-04-30,ACTUAL,2020-04-30,,INTERVENTIONAL,oGVHD,"The safety set includes all participants who signed informed consent forms, were randomized into the study, and took at least one dose of study drug.",Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease,"A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease",TERMINATED,,PHASE3,59.0,ACTUAL,Ocugen,,2.0,,Primary endpoint was not met.,f,,,,f,t,f,,,,,,A clinical Study Report will be submitted once the study data has been analyzed.,,,YES,There is no current plan to share participant data with other researchers.,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,INDUSTRY,,,,,,,2020,0.0
NCT04252742,,2020-01-22,2024-08-06,,2024-08-06,2020-01-30,2020-02-05,ACTUAL,2024-08-06,2024-08-30,ACTUAL,,,,2024-08-06,2024-08-30,ACTUAL,2020-09-15,ACTUAL,2020-09-15,2024-07,2024-07-31,2023-10-26,ACTUAL,2023-10-26,2023-10-26,ACTUAL,2023-10-26,,INTERVENTIONAL,EMBRACE,The full analysis set included all participants who were randomized in the study.,Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine,"Comprehensive Assessment of Erenumab Efficacy in Subjects With High Frequency Episodic Migraine With at Least 1 Previously Failed Preventive Treatment: a Global, Double-blind, Placebo-controlled Phase 4 Study",COMPLETED,,PHASE4,512.0,ACTUAL,Amgen,,2.0,,,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s)and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,INDUSTRY,,,,,,,2023,1.0
NCT04274907,,2020-02-17,,,2021-02-10,2020-02-17,2020-02-18,ACTUAL,,,,,,,2021-02-10,2021-02-11,ACTUAL,2020-06-30,ACTUAL,2020-06-30,2021-02,2021-02-28,2021-02-02,ACTUAL,2021-02-02,2021-02-02,ACTUAL,2021-02-02,,INTERVENTIONAL,,,A Safety Study of Oral Venetoclax in Combination With Intravenous Pembrolizumab in Adult Participants With Previously Untreated Non-Small Cell Lung Cancer (NSCLC) With High Programmed Cell Death Ligand-1 (PD-L1) Expression,A Phase 1b Study of Venetoclax in Combination With Pembrolizumab in Subjects With Previously Untreated NSCLC Whose Tumors Have High PD-L1 Expression,TERMINATED,,PHASE1,2.0,ACTUAL,AbbVie,,3.0,,Company Decision,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,INDUSTRY,,,,,,,2021,0.0
NCT03026023,,2017-01-13,,,2018-12-18,2017-01-19,2017-01-20,ESTIMATED,,,,,,,2018-12-18,2018-12-20,ACTUAL,2018-08-01,ESTIMATED,2018-08-01,2018-12,2018-12-31,2021-06-30,ESTIMATED,2021-06-30,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Preemptive Zepatier Treatment in Donor HCV Positive to Recipient HCV Negative Cardiac Transplant,A Proof of Concept Study for Preemptive Treatment With Grazoprevir and Elbasvir in Donor HCV-positive to Recipient HCV-negative Cardiac Transplant,WITHDRAWN,,PHASE4,0.0,ACTUAL,Massachusetts General Hospital,,1.0,,moved forward with another protocol utilizing pan genotypic treatment once it became commercially available and FDA approved,f,,,,t,t,f,,,f,,,,,,YES,Deidentified patient data will be shared with research collaborators for safety and data analysis.,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,OTHER,,,,,,,2021,0.0
NCT05355753,,2022-04-23,,,2024-01-18,2022-04-29,2022-05-02,ACTUAL,,,,,,,2024-01-18,2024-01-19,ACTUAL,2022-03-25,ACTUAL,2022-03-25,2024-01,2024-01-31,2023-12-19,ACTUAL,2023-12-19,2023-12-19,ACTUAL,2023-12-19,,INTERVENTIONAL,,,"A Study to Assess the Safety and Tolerability of CFT8634 in Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors","A Phase 1/2 Open-Label, Multicenter Study to Characterize the Safety and Tolerability of CFT8634 in Subjects With Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors",TERMINATED,,PHASE1/PHASE2,50.0,ACTUAL,"C4 Therapeutics, Inc.",,4.0,,High levels of BRD9 degradation did not result in sufficient efficacy in heavily pre-treated synovial sarcoma and SMARCB1-null solid tumor patients treated with CFT8634 as a single agent.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,INDUSTRY,,,,,,,2023,0.0
NCT03574597,,2018-06-21,2024-06-18,,2024-08-06,2018-06-21,2018-07-02,ACTUAL,2024-08-06,2024-08-30,ACTUAL,,,,2024-08-06,2024-08-30,ACTUAL,2018-10-24,ACTUAL,2018-10-24,2024-08,2024-08-31,2023-06-29,ACTUAL,2023-06-29,2023-06-21,ACTUAL,2023-06-21,,INTERVENTIONAL,SELECT,FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.,Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity,SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity,COMPLETED,,PHASE3,17604.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,t,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,INDUSTRY,,,,,,,2023,1.0
NCT04912427,,2021-05-27,,,2024-02-06,2021-06-02,2021-06-03,ACTUAL,,,,,,,2024-02-06,2024-02-09,ACTUAL,2022-04-01,ACTUAL,2022-04-01,2024-02,2024-02-29,2024-01-26,ACTUAL,2024-01-26,2022-12-06,ACTUAL,2022-12-06,,INTERVENTIONAL,,,"Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease","A Phase Ib Study of Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease",TERMINATED,,PHASE1,1.0,ACTUAL,Washington University School of Medicine,,1.0,,Low accrual,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,OTHER,,,,,,,2024,0.0
NCT05005507,,2021-08-12,2024-02-08,2022-12-28,2024-02-08,2021-08-12,2021-08-13,ACTUAL,2024-02-08,2024-03-06,ACTUAL,2022-12-28,2022-12-29,ACTUAL,2024-02-08,2024-03-06,ACTUAL,2021-11-03,ACTUAL,2021-11-03,2024-01,2024-01-31,2021-12-29,ACTUAL,2021-12-29,2021-12-29,ACTUAL,2021-12-29,,INTERVENTIONAL,PENGUIN-2,,"A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection","A Phase 2, Open-label, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Patients With Chronic Hepatitis B Virus Infection",TERMINATED,,PHASE2,1.0,ACTUAL,"Janssen Research & Development, LLC",Only 1 participant was enrolled in the study in Arm 1. Participants were also planned to be enrolled in Arms 2 and 3 but were not enrolled as the study terminated prematurely based on a strategic decision and not for safety reasons.,3.0,,A strategic decision was made to not further execute the study. This decision was not based on a safety concern.,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu",2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,INDUSTRY,,,,,,,2021,0.0
NCT06065059,,2023-09-15,,,2024-08-12,2023-09-26,2023-10-03,ACTUAL,,,,,,,2024-08-12,2024-08-13,ACTUAL,2023-12-08,ACTUAL,2023-12-08,2024-08,2024-08-31,2024-05-22,ACTUAL,2024-05-22,2024-05-22,ACTUAL,2024-05-22,,INTERVENTIONAL,,,Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors,"Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of TNG348 Single Agent and in Combination With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or Other HRD+ Solid Tumors",TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,"Tango Therapeutics, Inc.",,8.0,,Terminated due to safety,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,INDUSTRY,,,,,,,2024,0.0
NCT04688671,,2020-12-25,2023-02-27,,2023-11-06,2020-12-25,2020-12-30,ACTUAL,2023-04-21,2023-05-16,ACTUAL,,,,2023-11-06,2023-11-07,ACTUAL,2020-11-09,ACTUAL,2020-11-09,2023-11,2023-11-30,2022-02-18,ACTUAL,2022-02-18,2022-02-09,ACTUAL,2022-02-09,,INTERVENTIONAL,,,Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain,"A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects With Diabetic Peripheral Neuropathic Pain",COMPLETED,,PHASE2,167.0,ACTUAL,Eliem Therapeutics (UK) Ltd.,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,INDUSTRY,,,,,,,2022,1.0
NCT04444167,,2020-06-21,,,2024-04-23,2020-06-21,2020-06-23,ACTUAL,,,,,,,2024-04-23,2024-04-25,ACTUAL,2020-07-07,ACTUAL,2020-07-07,2024-04,2024-04-30,2023-11-20,ACTUAL,2023-11-20,2023-11-20,ACTUAL,2023-11-20,,INTERVENTIONAL,,,A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Plus Lenvatinib in First-line Advanced Hepatocellular Carcinoma,An Open-Label Multi-Center Phase Ib/II Study of Anti-PD-1/CTLA-4 Bispecific Antibody AK104 in Combination With Lenvatinib As the First-Line Therapy for Patients With Advanced Hepatocellular Carcinoma,COMPLETED,,PHASE1/PHASE2,59.0,ACTUAL,Akeso,,1.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,INDUSTRY,,,,,,,2023,1.0
NCT02816736,,2016-06-13,2021-09-15,,2021-12-02,2016-06-28,2016-06-29,ESTIMATED,2021-12-02,2021-12-03,ACTUAL,,,,2021-12-02,2021-12-03,ACTUAL,2017-03-02,ACTUAL,2017-03-02,2021-12,2021-12-31,2020-09-29,ACTUAL,2020-09-29,2020-09-15,ACTUAL,2020-09-15,,INTERVENTIONAL,HFN-LIFE,,EntrestoTM (LCZ696) In Advanced Heart Failure (LIFE Study),EntrestoTM (LCZ696) In Advanced Heart Failure (LIFE Study),COMPLETED,,PHASE4,365.0,ACTUAL,Duke University,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,OTHER,,,,,,,2020,1.0
NCT05148442,,2021-11-25,,,2023-09-05,2021-11-25,2021-12-08,ACTUAL,,,,,,,2023-09-05,2023-09-08,ACTUAL,2021-12-28,ACTUAL,2021-12-28,2023-09,2023-09-30,2023-08-29,ACTUAL,2023-08-29,2023-06-19,ACTUAL,2023-06-19,,INTERVENTIONAL,,,"A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor","A Phase Ia/Ib Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor",TERMINATED,,PHASE1,1.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,1.0,,Due to the company's development strategy adjustment\],f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,INDUSTRY,,,,,,,2023,0.0
NCT03553576,,2018-05-30,,,2024-04-16,2018-06-11,2018-06-12,ACTUAL,,,,,,,2024-04-16,2024-04-18,ACTUAL,2020-01-09,ACTUAL,2020-01-09,2024-04,2024-04-30,2023-06-01,ACTUAL,2023-06-01,2023-05-31,ACTUAL,2023-05-31,,INTERVENTIONAL,CADD2,,Drug Concentration and Volume on Adequate Labor Analgesia With PIEB,The Relationship Between Local Anesthetic Concentration and Volume on Adequate Labor Analgesia With Programmed Intermittent Epidural Bolus,TERMINATED,,PHASE4,156.0,ACTUAL,Northwestern University,,2.0,,Lack of continued funding,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,OTHER,,,,,,,2023,0.0
NCT04560010,,2020-09-17,2024-02-01,,2024-02-27,2020-09-17,2020-09-23,ACTUAL,2024-02-27,2024-03-26,ACTUAL,,,,2024-02-27,2024-03-26,ACTUAL,2020-10-06,ACTUAL,2020-10-06,2024-02,2024-02-29,2023-03-11,ACTUAL,2023-03-11,2023-03-11,ACTUAL,2023-03-11,,INTERVENTIONAL,,,TXA in Anticoagulated Patients Study,The Effect of Tranexamic Acid in Anticoagulated Patients Undergoing Total Shoulder Athroplasty,TERMINATED,,PHASE4,17.0,ACTUAL,NYU Langone Health,,2.0,,Enrollment rate was slower than anticipated,f,,,,t,t,f,,,t,,,9 months and ending 36 months following article publication,Requests may be directed to the PI.,,YES,The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,OTHER,,,,,,,2023,0.0
NCT04276415,,2020-02-14,2023-05-31,,2024-02-14,2020-02-17,2020-02-19,ACTUAL,2024-02-14,2024-02-15,ACTUAL,,,,2024-02-14,2024-02-15,ACTUAL,2020-05-08,ACTUAL,2020-05-08,2024-02,2024-02-29,2022-03-11,ACTUAL,2022-03-11,2022-03-11,ACTUAL,2022-03-11,,INTERVENTIONAL,,Demographic and baseline characteristics were assessed in the Safety Analysis Set.,DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST),"Phase 1, Multicenter, Open-Label, First-in-Human Study of DS-6157a in Subjects With Advanced Gastrointestinal Stromal Tumor",TERMINATED,,PHASE1,34.0,ACTUAL,Daiichi Sankyo,,3.0,,The study was terminated due to a business decision.,f,,,,f,t,f,,,,,,"Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,INDUSTRY,,,,,,,2022,0.0
NCT04129489,,2019-03-18,,,2020-06-14,2019-10-15,2019-10-16,ACTUAL,,,,,,,2020-06-14,2020-06-16,ACTUAL,2019-02-07,ACTUAL,2019-02-07,2020-06,2020-06-30,2020-03-01,ACTUAL,2020-03-01,2020-03-01,ACTUAL,2020-03-01,,INTERVENTIONAL,,,A Phase 2a Study to Evaluate the Safety and Efficacy of Cannabidiol Only as Maintenance Therapy and Steroid Sparing in Patients With Stable Autoimmune Hepatitis,"A Phase 2a Open Label, Single Arm Study to Evaluate the Safety and Efficacy of Cannabidiol Only as Maintenance Therapy and Steroid Sparing in Patients With Stable Autoimmune Hepatitis",TERMINATED,,PHASE2,2.0,ACTUAL,Stero Biotechs Ltd.,,1.0,,low recruitment,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,INDUSTRY,,,,,,,2020,0.0
NCT04735510,,2021-01-25,,,2023-04-18,2021-01-28,2021-02-03,ACTUAL,,,,,,,2023-04-18,2023-04-19,ACTUAL,2021-05,ESTIMATED,2021-05-31,2023-04,2023-04-30,2021-09,ESTIMATED,2021-09-30,2021-09,ESTIMATED,2021-09-30,,INTERVENTIONAL,,,Novel Use of Restasis and PROSE Devices,Novel Use of Restasis (Cyclosporine Ophthalmic Emulsion 0.05%) on Application of PROSE Devices for Management of Patients With Ocular Surface Disease: A Pilot Study,WITHDRAWN,,PHASE3,0.0,ACTUAL,Boston Sight,,1.0,,study redesigned,f,,,,f,t,f,,,,,,,,,NO,There is no plan to share IPD,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,OTHER,,,,,,,2021,0.0
NCT04001036,,2019-06-26,,,2023-03-02,2019-06-26,2019-06-27,ACTUAL,,,,,,,2023-03-02,2023-03-03,ACTUAL,2019-09-01,ACTUAL,2019-09-01,2022-08,2022-08-31,2022-08-30,ACTUAL,2022-08-30,2022-08-30,ACTUAL,2022-08-30,,INTERVENTIONAL,,,"Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD","Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol and L-Carnitine Compared to Standard PD Solutions in Continuous Ambulatory Peritoneal Dialysis (CAPD)",TERMINATED,,PHASE2,11.0,ACTUAL,Iperboreal Pharma Srl,,2.0,,prematurely interrupted due to significant difficulties in the completion of the sample size defined by the study protocol,f,,,,f,f,f,,,,,,,,,,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,INDUSTRY,,,,,,,2022,0.0
NCT03722589,,2018-10-15,2023-05-10,,2024-07-18,2018-10-25,2018-10-29,ACTUAL,2024-07-18,2024-07-22,ACTUAL,,,,2024-07-18,2024-07-22,ACTUAL,2018-09-12,ACTUAL,2018-09-12,2024-07,2024-07-31,2020-07-31,ACTUAL,2020-07-31,2020-07-31,ACTUAL,2020-07-31,,INTERVENTIONAL,,Baseline characteristics are presented for Year 1 participants. There were no Fluzone High-Dose participants enrolled in year 1.,Immunogenicity Trial of Egg- Versus Non-Egg-Based Influenza Vaccines Among HCP,Randomized Open-Label Trial to Compare the Immunogenicity of Cell Culture-Based and Recombinant Unadjuvanted Quadrivalent Influenza Vaccines to Conventional Egg-Based Unadjuvanted Quadrivalent Influenza Vaccines Among Healthcare Personnel Aged 18-64 Years,COMPLETED,,PHASE4,944.0,ACTUAL,Centers for Disease Control and Prevention,,5.0,,,f,,,,f,t,f,,,t,,,Study period,,,YES,IPD will be made available to contractor and site research staff. This data can be made available to other researchers upon request.,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,FED,,,,,,,2020,1.0
NCT03123744,,2017-03-03,,,2018-06-19,2017-04-20,2017-04-21,ACTUAL,,,,,,,2018-06-19,2018-06-21,ACTUAL,2018-07-01,ESTIMATED,2018-07-01,2018-06,2018-06-30,2024-02-01,ESTIMATED,2024-02-01,2020-02-01,ESTIMATED,2020-02-01,,INTERVENTIONAL,,,Histology-Independent Study of Palbociclib in Patients With Advanced Cancer,A Histology-Independent Study of the Cyclin Inhibitor Palbociclib in Patients With Advanced Cancer Harboring Aberrations in the Cyclin Pathway,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, San Diego",,1.0,,No study funding available.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,OTHER,,,,,,,2024,0.0
NCT03100877,,2017-03-29,,,2017-12-11,2017-03-29,2017-04-04,ACTUAL,,,,,,,2017-12-11,2017-12-13,ACTUAL,2018-01,ESTIMATED,2018-01-31,2017-12,2017-12-31,2020-05-24,ESTIMATED,2020-05-24,2020-05-24,ESTIMATED,2020-05-24,,INTERVENTIONAL,,,"Melphalan, Total Marrow Irradiation, and Autologous Stem Cell Transplantation in Treating Patients With High-Risk Multiple Myeloma",Phase I-II Single Cycle Melphalan/Total Marrow Irradiation (TMI) and Autologous Stem Cell Transplantation (ASCT) Followed by Maintenance in Patients With High-Risk Myeloma and/or Poor Response to Induction Therapy Within 12 Months of Diagnosis,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,City of Hope Medical Center,,1.0,,Feasibility Issues,f,,,,t,t,f,,,,,,,,,,,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,OTHER,,,,,,,2020,0.0
NCT05422001,,2022-05-27,,,2023-09-21,2022-06-14,2022-06-16,ACTUAL,,,,,,,2023-09-21,2023-09-26,ACTUAL,2022-05-31,ACTUAL,2022-05-31,2023-09,2023-09-30,2023-08-15,ACTUAL,2023-08-15,2023-08-15,ACTUAL,2023-08-15,,INTERVENTIONAL,KetMo,,Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED,"Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED: a Randomized, Double-blinded Clinical Trial",TERMINATED,,PHASE4,116.0,ACTUAL,University of Aarhus,,2.0,,Not able to recruit opioid tolerant patients as expected,f,,,,f,f,f,,,f,,,,,,YES,"Six month after the publication of the last results, all de-identified individual patient data will be made available for data sharing",2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,OTHER,,,,,,,2023,0.0
NCT03867240,,2019-03-06,,,2021-02-03,2019-03-06,2019-03-07,ACTUAL,,,,,,,2021-02-03,2021-02-08,ACTUAL,2019-06,ESTIMATED,2019-06-30,2021-02,2021-02-28,2022-09,ESTIMATED,2022-09-30,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,CPSP,,Gabapentin and Chronic Post Surgical Pain,"The Use of Perioperative Gabapentin in Adolescents Undergoing Posterior Spinal Fusion for Idiopathic Scoliosis to Prevent Chronic Postsurgical Pain, a Pilot Study.",WITHDRAWN,,PHASE3,0.0,ACTUAL,Emory University,,2.0,,Study initially suspended recruitment due to COVID-19. Study withdrawn due to PI leaving institution in early 2021.,f,,,,t,t,f,,,f,,,Data will become available immediately following publication and ending 5 years following article publication.,Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared for individual participant data meta-analysis.,,YES,"Individual participant data that underlie the results after de-identification (text, tables, figures and appendices) will be shared. The following related documents will be available: study protocol, statistical analysis plan, analytic code. Data will become available immediately following publication and ending 5 years following article publication. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared for individual participant data meta-analysis. Request for proposal should be directed to Cheryl.maenpaa@emory.edu.To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.",2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,OTHER,,,,,,,2022,0.0
NCT03103087,,2017-02-08,2022-03-23,2020-05-11,2022-03-23,2017-03-31,2017-04-06,ACTUAL,2022-03-23,2022-04-20,ACTUAL,2020-05-11,2020-05-13,ACTUAL,2022-03-23,2022-04-20,ACTUAL,2017-06-14,ACTUAL,2017-06-14,2021-09,2021-09-30,2020-09-16,ACTUAL,2020-09-16,2019-07-10,ACTUAL,2019-07-10,,INTERVENTIONAL,,All participants who were enrolled and randomized in the study.,LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids,"LIBERTY 2: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids",COMPLETED,,PHASE3,382.0,ACTUAL,Myovant Sciences GmbH,None reported,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,INDUSTRY,,,,,,,2020,1.0
NCT03628144,,2018-08-09,,,2020-09-09,2018-08-09,2018-08-14,ACTUAL,,,,,,,2020-09-09,2020-09-10,ACTUAL,2020-07,ESTIMATED,2020-07-31,2020-09,2020-09-30,2023-09,ESTIMATED,2023-09-30,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer,The Use of Immunonutrition to Reduce Toxicities From Concurrent Chemotherapy and Radiotherapy for Treatment of Unresectable Stage IIIA-B Non-Small Cell Lung Cancer (NSCLC),WITHDRAWN,,PHASE2,0.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,2.0,,Funding unavailable,,,,,f,t,f,,,,,,,,,,,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,OTHER,,,,,,,2023,0.0
NCT04277663,,2020-02-18,,,2023-03-07,2020-02-18,2020-02-20,ACTUAL,,,,,,,2023-03-07,2023-03-09,ACTUAL,2020-04-17,ACTUAL,2020-04-17,2023-03,2023-03-31,2023-02-28,ACTUAL,2023-02-28,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,,,The Study of IBI310 in Combination With IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery,"A Phase 3, Open-label, Multicenter Study, IBI310 in Combination With IBI308 and IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery",TERMINATED,,PHASE3,136.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,3.0,,Due to the company's development strategy adjustment ，Innovent Bioligics decided not to continue the study after consultation with investigators,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 23:47:47.465427,2024-10-14 23:47:47.465427,INDUSTRY,,,,,,,2023,0.0
NCT01582776,,2012-04-20,,,2023-03-16,2012-04-20,2012-04-23,ESTIMATED,,,,,,,2023-03-16,2023-03-17,ACTUAL,2012-10-03,ACTUAL,2012-10-03,2023-03,2023-03-31,2022-05-20,ACTUAL,2022-05-20,2018-07-11,ACTUAL,2018-07-11,,INTERVENTIONAL,,,Study of OBINUTUZUMAB Combined to LENALIDOMIDE for the Treatment of Relapsed/Refractory Follicular and Aggressive B-cell Lymphoma,A Phase Ib/II Study of OBINUTUZUMAB Combined to LENALIDOMIDE for the Treatment of Follicular and Relapsed/Refractory Aggressive (DLBCL and MCL) B-cell Lymphoma,COMPLETED,,PHASE1/PHASE2,317.0,ACTUAL,The Lymphoma Academic Research Organisation,,1.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 20:47:06.80761,2024-10-16 20:47:06.80761,OTHER,,,,,,,2022,1.0
NCT05956275,,2023-07-04,,,2023-07-13,2023-07-13,2023-07-21,ACTUAL,,,,,,,2023-07-13,2023-07-21,ACTUAL,2020-12-08,ACTUAL,2020-12-08,2023-07,2023-07-31,2021-10-02,ACTUAL,2021-10-02,2021-10-01,ACTUAL,2021-10-01,,INTERVENTIONAL,,,USG-Guided Infiltration Popliteal Artery Capsule Knee Block Versus Adductor Canal Block Application as Postoperative Analgesia,Comparison Between USG-Guided Infiltration Popliteal Artery Capsule Knee Block Versus Adductor Canal Block Application as Postoperative Analgesia in Total Knee Prosthesis Under General Anesthesia: Randomized Clinical Trial,COMPLETED,,PHASE4,20.0,ACTUAL,Siirt Training and Research Hospital,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,This study is a thesis that I did and presented two years ago. The raw data has not been backed up after going through statistical analysis.,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,OTHER_GOV,,,,,,,2021,1.0
NCT04641962,,2020-11-19,,,2024-08-28,2020-11-19,2020-11-24,ACTUAL,,,,,,,2024-08-28,2024-08-30,ACTUAL,2021-05-17,ACTUAL,2021-05-17,2024-08,2024-08-31,2024-05-08,ACTUAL,2024-05-08,2024-05-08,ACTUAL,2024-05-08,,INTERVENTIONAL,MOUNTAINSIDE,,A Study to Evaluate ASP0367 in Participants With Primary Mitochondrial Myopathy,"A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Assess the Efficacy, Safety and Tolerability of ASP0367 in Participants With Primary Mitochondrial Myopathy",TERMINATED,,PHASE2,34.0,ACTUAL,Astellas Pharma Inc,,3.0,,Due to failure to meet the pre-specified criteria for efficacy,f,,,,t,t,f,,,,,,,,,NO,Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.,2024-10-15 13:48:32.231755,2024-10-15 13:48:32.231755,INDUSTRY,,,,,,,2024,0.0
NCT05588440,,2022-09-23,,,2024-09-19,2022-10-18,2022-10-20,ACTUAL,,,,,,,2024-09-19,2024-09-23,ACTUAL,2023-05-09,ACTUAL,2023-05-09,2024-06,2024-06-30,2024-09-12,ACTUAL,2024-09-12,2024-09-12,ACTUAL,2024-09-12,,INTERVENTIONAL,,,A Clinical Study of ONCT-808 in Subjects with Relapsed or Refractory B-Cell Malignancies,Phase 1/2 Multi-Center Study to Evaluate the Safety and Efficacy of ONCT-808 in Adult Subjects with Relapsed or Refractory Aggressive B-Cell Malignancies,TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,"Oncternal Therapeutics, Inc",,2.0,,"Based on the available clinical data and capital requirements for continued development, the Company has decided to terminate this study.",f,,,,f,t,f,,,f,,,,,,UNDECIDED,,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,INDUSTRY,,,,,,,2024,0.0
NCT03425006,,2018-01-22,2023-06-29,2022-05-24,2023-08-31,2018-02-05,2018-02-07,ACTUAL,2023-08-31,2023-09-13,ACTUAL,,2023-09-13,ACTUAL,2023-08-31,2023-09-13,ACTUAL,2018-06-18,ACTUAL,2018-06-18,2023-08,2023-08-31,2021-10-11,ACTUAL,2021-10-11,2021-06-17,ACTUAL,2021-06-17,,INTERVENTIONAL,,,Pembrolizumab and Itacitinib (INCB039110) for Non-Small Cell Lung Cancer,Phase II Study of Pembrolizumab and Itacitinib (INCB039110) for First Line Treatment of Metastatic Non-Small Cell Lung Cancer Expressing PD-L1,TERMINATED,,PHASE2,23.0,ACTUAL,University of Pennsylvania,,1.0,,Administrative reasons,f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,OTHER,,,,,,,2021,0.0
NCT05475665,,2022-07-24,,,2023-08-15,2022-07-24,2022-07-27,ACTUAL,,,,,,,2023-08-15,2023-08-18,ACTUAL,2022-07-14,ACTUAL,2022-07-14,2023-08,2023-08-31,2023-06-13,ACTUAL,2023-06-13,2023-03-30,ACTUAL,2023-03-30,,INTERVENTIONAL,,,Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension Patients,"A Randomized, Double-blind, Multicenter, Placebo-control, Parallel Group Phase # Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients",COMPLETED,,PHASE3,157.0,ACTUAL,Handok Inc.,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,INDUSTRY,,,,,,,2023,1.0
NCT04634344,,2020-11-02,,,2022-07-06,2020-11-12,2020-11-18,ACTUAL,,,,,,,2022-07-06,2022-07-11,ACTUAL,2021-04-12,ACTUAL,2021-04-12,2022-07,2022-07-31,2022-05-05,ACTUAL,2022-05-05,2022-05-05,ACTUAL,2022-05-05,,INTERVENTIONAL,,,"Assess the Safety, Tolerability, PK and Anti-tumor Efficacy of DZD2269 in Patients With MCRPC","A Phase I, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD2269 in Patients With Metastatic Castration Resistant Prostate Cancer",TERMINATED,,PHASE1,16.0,ACTUAL,Dizal Pharmaceuticals,,1.0,,"Due to reasons of internal business strategy, not related to study or site conduct.",f,,,,,t,f,,,,,,,,,NO,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,INDUSTRY,,,,,,,2022,0.0
NCT03282669,,2017-09-12,,,2022-05-05,2017-09-12,2017-09-14,ACTUAL,,,,,,,2022-05-05,2022-05-06,ACTUAL,2019-08,ESTIMATED,2019-08-31,2022-05,2022-05-31,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,TC02 Obese Women Using It Morphine vs PCA IV Hydromorphone for Post-Cesarean Analgesia,Randomized Controlled Trial Evaluating the Transcutaneous Carbon Dioxide Measurements in Obese Women Using Intrathecal Morphine Versus Patient-Controlled Intravenous Hydromorphone for Post-Cesarean Analgesia,WITHDRAWN,,PHASE4,0.0,ACTUAL,Northwestern University,,2.0,,Change in institutional policy. Change in resources available.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,OTHER,,,,,,,2021,0.0
NCT03360448,,2017-11-13,,,2019-06-05,2017-11-27,2017-12-04,ACTUAL,,,,,,,2019-06-05,2019-06-07,ACTUAL,2019-06,ESTIMATED,2019-06-30,2019-06,2019-06-30,2023-06,ESTIMATED,2023-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,FLOURISH,,AC6 Gene Transfer in Patients With Reduced Left Ventricular Ejection Fraction Heart Failure,"Randomized, Phase 3, Placebo-Controlled Double-Blind, Multicenter Trial of a One Time Intracoronary Administration of Ad5.hAC6 Gene Transfer for Patients With Reduced Left Ventricular Heart Failure",WITHDRAWN,,PHASE3,0.0,ACTUAL,Renova Therapeutics,,2.0,,Clinical development plans and strategy for RT-100 being re-evaluated,f,,,,t,t,f,,,,,,,,,UNDECIDED,Blinded study - de-identified participant data to become available after completion of study.,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,INDUSTRY,,,,,,,2023,0.0
NCT04370548,,2020-04-03,2021-06-11,,2022-12-06,2020-04-28,2020-05-01,ACTUAL,2021-06-11,2021-07-02,ACTUAL,,,,2022-12-06,2022-12-08,ACTUAL,2020-06-16,ACTUAL,2020-06-16,2022-12,2022-12-31,2020-12-07,ACTUAL,2020-12-07,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,,,DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE),"A Phase 3 Multi-Center, Double-Blind, Placebo-Controlled, Randomized Study of DARE-BV1 in the Treatment of Bacterial Vaginosis",COMPLETED,,PHASE3,307.0,ACTUAL,"Daré Bioscience, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,INDUSTRY,,,,,,,2020,1.0
NCT03193814,,2017-06-17,,,2023-12-31,2017-06-20,2017-06-21,ACTUAL,,,,,,,2023-12-31,2024-01-03,ACTUAL,2019-12-01,ACTUAL,2019-12-01,2023-12,2023-12-31,2024-12-01,ESTIMATED,2024-12-01,2022-12-01,ESTIMATED,2022-12-01,,INTERVENTIONAL,XHZL,,Safety and Efficacy Study of Chemotherapy Plus Apatinib as Second-line Therapy in Metastatic Colorectal Cancer,Study Evaluating the Safety and Efficacy of FOLFOX Plus Apatinib or FOLFIRI Plus Apatinib as Second-line Therapy in Metastatic Colorectal Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Wuhan Union Hospital, China",,1.0,,Inadequate patient enrollment,f,,,,,f,f,,,,,,,,,,,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,OTHER,,,,,,,2024,0.0
NCT03102996,,2017-03-31,,,2022-04-21,2017-04-05,2017-04-06,ACTUAL,,,,,,,2022-04-21,2022-04-22,ACTUAL,2017-06-12,ACTUAL,2017-06-12,2022-04,2022-04-30,2021-07-26,ACTUAL,2021-07-26,2021-06-29,ACTUAL,2021-06-29,,INTERVENTIONAL,,,Preserve-Transplant Study,Preservation of Kidney Function in Kidney Transplant Recipients by Alkali Therapy (Preserve-Transplant Study): a Multi-center Randomized Single-blind Placebo- Controlled Trial,COMPLETED,,PHASE4,240.0,ACTUAL,University of Zurich,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,OTHER,,,,,,,2021,0.0
NCT02509039,,2015-07-23,2024-05-06,,2024-05-06,2015-07-23,2015-07-27,ESTIMATED,2024-05-06,2024-09-23,ACTUAL,,,,2024-05-06,2024-09-23,ACTUAL,2015-09-02,ACTUAL,2015-09-02,2024-04,2024-04-30,2023-05-09,ACTUAL,2023-05-09,2023-05-09,ACTUAL,2023-05-09,,INTERVENTIONAL,,,A Study of CC-122 to Assess the Safety and Tolerability in Japanese Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma (NHL),"A Phase 1, Multi-center, Open-label Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of CC-122 Administered Orally to Adult Japanese Subjects With Advanced Solid Tumors or Non-Hodgkin's Lymphoma",TERMINATED,,PHASE1,15.0,ACTUAL,Celgene,,1.0,,Replaced it with another clinical trial.,f,,,,,,,,,,,,,,,,,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,INDUSTRY,,,,,,,2023,0.0
NCT03411031,,2018-01-19,2022-02-18,,2023-03-28,2018-01-24,2018-01-25,ACTUAL,2022-03-21,2022-04-14,ACTUAL,,,,2023-03-28,2023-03-29,ACTUAL,2018-10-04,ACTUAL,2018-10-04,2023-03,2023-03-31,2021-11-04,ACTUAL,2021-11-04,2021-02-18,ACTUAL,2021-02-18,,INTERVENTIONAL,,,Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide,A Randomized Parallel Phase 2 Study of Elotuzumab Plus Lenalidomide (Elo/Rev) for the Treatment of Serologic Relapse/Progression While on Lenalidomide Maintenance for Multiple Myeloma,TERMINATED,,PHASE2,18.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,2.0,,Sponsor no longer providing drug,f,,,,f,t,f,,,,,,,,,,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,OTHER,,,,,,,2021,0.0
NCT01253070,,2010-12-02,2016-01-13,,2022-08-03,2010-12-02,2010-12-03,ESTIMATED,2016-01-13,2016-02-11,ESTIMATED,,,,2022-08-03,2022-08-04,ACTUAL,2011-04-01,ACTUAL,2011-04-01,2022-08,2022-08-31,2021-04-15,ACTUAL,2021-04-15,2014-10-31,ACTUAL,2014-10-31,,INTERVENTIONAL,,,Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia,A Phase II Study Incorporating Sorafenib (NSC 724772) Into the Therapy of Patients &gt;/= 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia,COMPLETED,,PHASE2,54.0,ACTUAL,National Cancer Institute (NCI),,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,NIH,,,,,,,2021,1.0
NCT03162562,,2017-05-04,,,2020-12-18,2017-05-19,2017-05-22,ACTUAL,,,,,,,2020-12-18,2020-12-22,ACTUAL,2017-05-30,ACTUAL,2017-05-30,2020-12,2020-12-31,2020-11-05,ACTUAL,2020-11-05,2020-11-05,ACTUAL,2020-11-05,,INTERVENTIONAL,,,The Safety and Antitumor Activity of the Combination of Oregovomab and Hiltonol in Recurrent Advanced Ovarian Cancer,"Prospective Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of Oregovomab and Hiltonol® as a Combinatorial Immunotherapy Strategy in Patients With Recurrent Advanced Epithelial Cancer of Ovarian, Tubal, or Peritoneal Origin",TERMINATED,,PHASE1,10.0,ACTUAL,CanariaBio Inc.,,1.0,,Sponsor Decision to discontinue long-term follow-up,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,INDUSTRY,,,,,,,2020,0.0
NCT03733249,,2018-11-02,2023-06-22,,2023-09-22,2018-11-05,2018-11-07,ACTUAL,2023-09-22,2023-09-26,ACTUAL,,,,2023-09-22,2023-09-26,ACTUAL,2017-01,ACTUAL,2017-01-31,2023-09,2023-09-30,2023-04-14,ACTUAL,2023-04-14,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,HSCT safety population: All enrolled patients who received hematopoietic stem cell transplantation,Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study,Follow-up of Phase 1/2 Study of CaspaCIDe T Cells (BPX-501) From an HLA-partially Matched Family Donor After Negative Selection of TCR αβ+T Cells in Pediatric Patients Affected by Hematological Disorders,TERMINATED,,PHASE1/PHASE2,187.0,ACTUAL,Bellicum Pharmaceuticals,,1.0,,,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 10:10:04.261258,2024-10-16 10:10:04.261258,INDUSTRY,,,,,,,2023,0.0
NCT01509339,,2012-01-09,,,2021-12-23,2012-01-10,2012-01-13,ESTIMATED,,,,,,,2021-12-23,2022-01-12,ACTUAL,2012-01,ESTIMATED,2012-01-31,2021-12,2021-12-31,2021-12-23,ACTUAL,2021-12-23,2021-12-23,ACTUAL,2021-12-23,,INTERVENTIONAL,,,Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis,Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis,WITHDRAWN,,PHASE1,0.0,ACTUAL,Case Western Reserve University,,1.0,,Lab unable to measure vancomycin levels in Sputum,f,,,,t,,,,,,,,,,,,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,OTHER,,,,,,,2021,0.0
NCT04475549,,2020-07-14,2023-10-17,2023-01-20,2024-08-13,2020-07-14,2020-07-17,ACTUAL,2023-11-13,2023-11-15,ACTUAL,,2023-11-15,ACTUAL,2024-08-13,2024-08-29,ACTUAL,2020-11-13,ACTUAL,2020-11-13,2024-08,2024-08-31,2022-01-23,ACTUAL,2022-01-23,2022-01-23,ACTUAL,2022-01-23,,INTERVENTIONAL,,,"Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)","A Phase 2a Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Individuals With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)",TERMINATED,,PHASE2,8.0,ACTUAL,Tisento Therapeutics,,1.0,,Study terminated due to enrollment challenges.,,,,,f,t,f,,,,,,,,,NO,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,INDUSTRY,,,,,,,2022,0.0
NCT03661567,,2018-09-01,,,2022-11-25,2018-09-05,2018-09-07,ACTUAL,,,,,,,2022-11-25,2022-11-30,ACTUAL,2018-08-09,ACTUAL,2018-08-09,2022-11,2022-11-30,2021-09-10,ACTUAL,2021-09-10,2021-09-10,ACTUAL,2021-09-10,,INTERVENTIONAL,,,Methylprednisolone After Split-course Chemoradiotherapy For Bulky Local Advanced None-small Cell Lung Cancer,"A Prospective, Randomized, Controlled Phase Ⅱ Study of Preventively Use of Methylprednisolone After Split-course Chemoradiotherapy to Reduce the Risk of Radiation-induced Pulmonary Injury For Bulky Local Advanced None-small Cell Lung Cancer",TERMINATED,,PHASE2,52.0,ACTUAL,Sun Yat-sen University,,2.0,,slow enrollment,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,OTHER,,,,,,,2021,0.0
NCT02633293,,2015-12-11,2022-07-26,,2022-11-08,2015-12-14,2015-12-17,ESTIMATED,2022-11-08,2022-12-02,ACTUAL,,,,2022-11-08,2022-12-02,ACTUAL,2016-09-15,ACTUAL,2016-09-15,2022-11,2022-11-30,2021-08-01,ACTUAL,2021-08-01,2021-08-01,ACTUAL,2021-08-01,,INTERVENTIONAL,,Safety Population,An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE,An Open-Label Extension Study of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Parenchymal Lung Disease,TERMINATED,,PHASE2/PHASE3,243.0,ACTUAL,United Therapeutics,,1.0,,Inhaled treprostinil became commercially available in the US following its approval for PH-ILD,f,,,,t,,,,,,,,,,,,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,INDUSTRY,,,,,,,2021,0.0
NCT03300947,,2017-09-14,,,2024-08-29,2017-10-02,2017-10-04,ACTUAL,,,,,,,2024-08-29,2024-08-30,ACTUAL,2019-01-02,ACTUAL,2019-01-02,2024-08,2024-08-31,2023-12-30,ACTUAL,2023-12-30,2023-10-30,ACTUAL,2023-10-30,,INTERVENTIONAL,PSILOCD,,Psilocybin for Treatment of Obsessive Compulsive Disorder,Psilocybin for Treatment of Obsessive Compulsive Disorder,COMPLETED,,PHASE1,15.0,ACTUAL,University of Arizona,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,OTHER,,,,,,,2023,1.0
NCT04501211,,2018-10-31,,,2022-02-11,2020-08-01,2020-08-06,ACTUAL,,,,,,,2022-02-11,2022-02-14,ACTUAL,2019-01-01,ESTIMATED,2019-01-01,2022-02,2022-02-28,2021-12-31,ESTIMATED,2021-12-31,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Open Label Transdermal Granisetron to Relieve Chronic Nausea and Emesis,Open Label Transdermal Granisetron to Relieve Chronic Nausea and Emesis and to Reduce Medical Utilization in Patients With Gastroparesis,WITHDRAWN,,PHASE2,0.0,ACTUAL,Indiana University,,1.0,,Abandoned due to limited resources,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,OTHER,,,,,,,2021,0.0
NCT04389450,,2020-05-14,,,2024-08-29,2020-05-14,2020-05-15,ACTUAL,,,,,,,2024-08-29,2024-08-30,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2024-08,2024-08-31,2023-06-07,ACTUAL,2023-06-07,2021-05-17,ACTUAL,2021-05-17,,INTERVENTIONAL,,,"Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19","A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of Severe COVID-19",TERMINATED,,PHASE2,66.0,ACTUAL,Pluristem Ltd.,,5.0,,"The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients",,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,INDUSTRY,,,,,,,2023,0.0
NCT04305184,,2020-03-10,2024-01-11,,2024-09-06,2020-03-10,2020-03-12,ACTUAL,2024-01-11,2024-02-07,ACTUAL,,,,2024-09-06,2024-09-20,ACTUAL,2020-09-10,ACTUAL,2020-09-10,2024-08,2024-08-31,2023-01-24,ACTUAL,2023-01-24,2023-01-24,ACTUAL,2023-01-24,,INTERVENTIONAL,,Safety Analysis Set (SAF) consisted of all randomized participants who received a dose of study drug.,A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP),"A Phase 1/2, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of ASP0598 Otic Solution Following Topical Application Into the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP)",TERMINATED,,PHASE1/PHASE2,36.0,ACTUAL,Astellas Pharma Inc,"Due to limitations of the TM imaging data as evaluated by the central reader, secondary endpoints related to change in TMP size could not be fully evaluated. Following SAD and MAD data review by DMC, the single dose of ASP0598 Otic Solution provided insufficient efficacy to open the single dose expansion study.",8.0,,Lack of Efficacy,f,,,,f,t,f,,,,,,,,,NO,Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,INDUSTRY,,,,,,,2023,0.0
NCT05122182,,2021-11-14,,,2023-09-13,2021-11-14,2021-11-16,ACTUAL,,,,,,,2023-09-13,2023-09-15,ACTUAL,2022-01-07,ACTUAL,2022-01-07,2023-09,2023-09-30,2023-01-28,ACTUAL,2023-01-28,2022-08-15,ACTUAL,2022-08-15,,INTERVENTIONAL,CLARITY 2,,Controlled Trial of Angiotensin Receptor Blocker (ARB) & Chemokine Receptor Type 2 (CCR2) Antagonist for the Treatment of COVID-19,"An Investigator Initiated, International Multi-Centre, Multi-Arm, Multi-Stage Randomised Double Blind Placebo Controlled Trial of Angiotensin Receptor Blocker (ARB) & Chemokine Receptor Type 2 (CCR2) Antagonist for the Treatment of COVID-19",TERMINATED,,PHASE2,49.0,ACTUAL,University of Sydney,,3.0,,Withdrawal of funding support from the trial funder.,f,,,,t,f,f,,,,,,,Data will be available after publication for an indefinite time / for a finite time (specify dates) All data requests will be considered by the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement that the requester must agree to before access is granted.~Access can be requested via the Health Data Australia catalogue,https://researchdata.edu.au/health/,YES,"Trial data will be disseminated in the form of a publication to a relevant clinical journal and presentation at appropriate scientific conferences.~Individual participant data that underlie the results reported, after de-identification (text, tables, figures, and appendices), may be shared with Investigators whose proposed use of the data has been approved by an independent review committee (learned intermediary) identified for this purpose.",2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,OTHER,,,,,,,2023,0.0
NCT03517501,,2018-04-23,,,2019-09-11,2018-05-04,2018-05-07,ACTUAL,,,,,,,2019-09-11,2019-09-13,ACTUAL,2019-07,ESTIMATED,2019-07-31,2019-06,2019-06-30,2023-05,ESTIMATED,2023-05-31,2022-04,ESTIMATED,2022-04-30,,INTERVENTIONAL,Scarlet2,,The Safety And Efficacy of ART-123 in Subjects With Sepsis and Coagulopathy,"Scarlet-2: A Randomized, Double-Blind,Placebo-Controlled, Phase 3 Study to Assess The Safety And Efficacy of ART-123 in Subjects With Sepsis and Coagulopathy",WITHDRAWN,,PHASE3,0.0,ACTUAL,Asahi Kasei Pharma America Corporation,,2.0,,Sponsor will amend study design by incorporating reconfirmation of coagulopathy following discussion with FDA regarding findings from SCARLET1 study.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,INDUSTRY,,,,,,,2023,0.0
NCT04594031,,2020-09-28,,,2022-06-29,2020-10-18,2020-10-20,ACTUAL,,,,,,,2022-06-29,2022-07-05,ACTUAL,2021-07-13,ACTUAL,2021-07-13,2022-06,2022-06-30,2024-02-02,ESTIMATED,2024-02-02,2023-09-01,ESTIMATED,2023-09-01,,INTERVENTIONAL,,,US Phase I Study of ECT-001-CB in Patients With Sickle-Cell Disease,A Phase I Multicenter Study of Hematopoietic Stem Cell Transplant of ECT-001-Expanded Cord Blood With a Reduced Toxicity Conditioning Regimen in Patients With Severe Sickle Cell Disease,WITHDRAWN,,PHASE1,0.0,ACTUAL,ExCellThera inc.,,1.0,,Preference given to gene therapy approaches by the SCD research community and patients' associations,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,INDUSTRY,,,,,,,2024,0.0
NCT02869243,,2016-08-02,,,2024-02-15,2016-08-11,2016-08-16,ESTIMATED,,,,,,,2024-02-15,2024-02-16,ACTUAL,2017-07-18,ACTUAL,2017-07-18,2024-02,2024-02-29,2021-06-30,ACTUAL,2021-06-30,2020-10-16,ACTUAL,2020-10-16,,INTERVENTIONAL,,,A Dose Escalation Phase I Study Of Human- Recombinant Bone Morphogenetic Protein 4 Administrated Via CED In GBM Patients,A Dose Escalation Phase I Study Of Human- Recombinant Bone Morphogenetic Protein 4 Administrated Via Convection-Enhanced Delivery In Patients With Progressive And/Or Multiple Recurrent Glioblastoma Multiforme,COMPLETED,,PHASE1,15.0,ACTUAL,Stemgen,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,INDUSTRY,,,,,,,2021,1.0
NCT04708236,,2021-01-08,,,2021-06-09,2021-01-12,2021-01-13,ACTUAL,,,,,,,2021-06-09,2021-06-14,ACTUAL,2021-04,ESTIMATED,2021-04-30,2021-06,2021-06-30,2021-07,ESTIMATED,2021-07-31,2021-05,ESTIMATED,2021-05-31,,INTERVENTIONAL,,,A Study of ORTD-1 in Patients Hospitalized With COVID-19 Related Pneumonia,"A Blinded, Controlled, Escalating Dose Study of ORTD-1 for Treatment of Hospitalized Patients With SARS-CoV-2 (COVID-19) Related Pneumonia.",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Oryn Therapeutics, LLC",,4.0,,recruitment,f,,,,t,t,f,,,,,,,,,,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,INDUSTRY,,,,,,,2021,0.0
NCT03015402,,2017-01-05,2024-03-13,2024-01-25,2024-06-06,2017-01-06,2017-01-10,ESTIMATED,2024-06-06,2024-06-07,ACTUAL,,2024-06-07,ACTUAL,2024-06-06,2024-06-07,ACTUAL,2017-10-30,ACTUAL,2017-10-30,2024-06,2024-06-30,2023-01-25,ACTUAL,2023-01-25,2023-01-25,ACTUAL,2023-01-25,,INTERVENTIONAL,PH-HFpEF,,Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction,Phase II Clinical Investigation of Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (PH-HFpEF),COMPLETED,,PHASE2,33.0,ACTUAL,University of Pittsburgh,This was a small clinical trial that under-enrolled due to the pandemic.,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,OTHER,,,,,,,2023,1.0
NCT05072080,,2021-09-28,2024-04-02,2023-11-22,2024-08-06,2021-09-28,2021-10-08,ACTUAL,2024-08-06,2024-08-30,ACTUAL,,2024-08-30,ACTUAL,2024-08-06,2024-08-30,ACTUAL,2021-09-29,ACTUAL,2021-09-29,2024-08,2024-08-31,2023-04-03,ACTUAL,2023-04-03,2023-04-03,ACTUAL,2023-04-03,,INTERVENTIONAL,,,A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (CHIKV VLP Vaccine),"A Phase 3 Safety, Immunogenicity, and Lot-Consistency Trial of the VLP-Based Chikungunya Vaccine PXVX0317 in Healthy Adults and Adolescents",COMPLETED,,PHASE3,3258.0,ACTUAL,Bavarian Nordic,,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,INDUSTRY,,,,,,,2023,1.0
NCT03634228,,2018-08-09,2023-04-03,,2023-05-22,2018-08-14,2018-08-16,ACTUAL,2023-05-22,2023-06-15,ACTUAL,,,,2023-05-22,2023-06-15,ACTUAL,2018-12-17,ACTUAL,2018-12-17,2023-05,2023-05-31,2022-04-03,ACTUAL,2022-04-03,2022-04-03,ACTUAL,2022-04-03,,INTERVENTIONAL,,,Milademetan Tosylate and Low-Dose Cytarabine With or Without Venetoclax in Treating Participants With Recurrent or Refractory Acute Myeloid Leukemia,A Phase I/II Study of the Oral MDM2 Inhibitor DS-3032b (Milademetan) in Combination With Low Dose Cytarabine (LDAC) in Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia (AML),TERMINATED,,PHASE1/PHASE2,16.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,"This study was terminated early due to lack of adequate response, and did not move to the Phase II portion of the study",f,,,,f,t,f,,,,,,,,,,,2024-10-16 10:10:04.261258,2024-10-16 10:10:04.261258,OTHER,,,,,,,2022,0.0
NCT03644589,,2018-08-22,,,2019-04-24,2018-08-22,2018-08-23,ACTUAL,,,,,,,2019-04-24,2019-04-26,ACTUAL,2019-04-01,ESTIMATED,2019-04-01,2019-04,2019-04-30,2022-10-30,ESTIMATED,2022-10-30,2021-10-30,ESTIMATED,2021-10-30,,INTERVENTIONAL,,,"Effect of Pembrolizumab and Cisplatin on Metastatic, Locally Recurrent or Inoperable Triple-Negative Breast Cancer",A Phase II Trial Evaluating Safety and Efficacy of Pembrolizumab and Cisplatin in Patients With Advanced Triple Negative Breast Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Washington,,1.0,,No participants enrolled.,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 10:10:04.261258,2024-10-16 10:10:04.261258,OTHER,,,,,,,2022,0.0
NCT03894007,,2019-03-21,,,2021-09-22,2019-03-26,2019-03-28,ACTUAL,,,,,,,2021-09-22,2021-09-23,ACTUAL,2019-05-23,ACTUAL,2019-05-23,2021-09,2021-09-30,2021-06-30,ACTUAL,2021-06-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,PREDIXIIHER2,,Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer,Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes,TERMINATED,,PHASE2,6.0,ACTUAL,Karolinska University Hospital,,2.0,,Security and effect data from another ongoing study.,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,OTHER,,,,,,,2021,0.0
NCT04376684,,2020-05-04,2022-02-28,,2024-09-06,2020-05-04,2020-05-06,ACTUAL,2022-02-28,2022-03-09,ACTUAL,,,,2024-09-06,2024-09-23,ACTUAL,2020-05-28,ACTUAL,2020-05-28,2024-09,2024-09-30,2021-08-16,ACTUAL,2021-08-16,2021-07-15,ACTUAL,2021-07-15,,INTERVENTIONAL,OSCAR,Baseline characteristics were presented for Enrolled Population.,Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease,"A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19 Related Disease",COMPLETED,,PHASE2,1156.0,ACTUAL,GlaxoSmithKline,,4.0,,,f,,,,t,t,f,,,,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://www.gsk.com/en-gb/innovation/trials/data-transparency,YES,Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,INDUSTRY,,,,,,,2021,1.0
NCT04724772,,2021-01-05,,,2024-07-19,2021-01-25,2021-01-26,ACTUAL,,,,,,,2024-07-19,2024-07-23,ACTUAL,2020-02-20,ACTUAL,2020-02-20,2024-07,2024-07-31,2023-09-20,ESTIMATED,2023-09-20,2023-07-20,ESTIMATED,2023-07-20,,INTERVENTIONAL,,,Use of Tranexamic Acid in Blepharoplasties,Comparison of Clinical Outcomes Following Upper Lid Blepharoplasty With and Without Tranexamic Acid as an Additive to Traditional Local Anesthetic.,WITHDRAWN,,PHASE3,0.0,ACTUAL,Northwestern University,,1.0,,Stopped study due to pharmacy issues before treating patients,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 10:10:04.261258,2024-10-16 10:10:04.261258,OTHER,,,,,,,2023,0.0
NCT05317312,,2022-03-16,2023-06-14,,2023-08-03,2022-04-06,2022-04-07,ACTUAL,2023-08-03,2023-08-07,ACTUAL,,,,2023-08-03,2023-08-07,ACTUAL,2022-03-31,ACTUAL,2022-03-31,2023-08,2023-08-31,2022-06-20,ACTUAL,2022-06-20,2022-06-15,ACTUAL,2022-06-15,,INTERVENTIONAL,,,Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.,"A Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Response Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.",COMPLETED,,PHASE2,111.0,ACTUAL,Viatris Inc.,,4.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,INDUSTRY,,,,,,,2022,1.0
NCT03373877,,2017-11-29,,,2022-11-14,2017-12-11,2017-12-14,ACTUAL,,,,,,,2022-11-14,2022-11-15,ACTUAL,2018-05-24,ACTUAL,2018-05-24,2022-11,2022-11-30,2020-03-10,ACTUAL,2020-03-10,2019-10-17,ACTUAL,2019-10-17,,INTERVENTIONAL,,,Evaluation of Ruxolitinib in Combination With PU-H71 for Treatment of Myelofibrosis,"A Phase Ib Study of Ruxolitinib in Combination With PU-H71 for the Treatment of Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV MF), and Post-EssentialThrombocythemia MF (Post-ET MF)",TERMINATED,,PHASE1,4.0,ACTUAL,"Samus Therapeutics, Inc.",,4.0,,Samus is focusing all of their efforts in myelofibrosis on the new oral formulation of PU-H71.,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,INDUSTRY,,,,,,,2020,0.0
NCT02111798,,2014-03-28,2021-05-17,,2021-08-24,2014-04-10,2014-04-11,ESTIMATED,2021-08-24,2021-09-20,ACTUAL,,,,2021-08-24,2021-09-20,ACTUAL,2014-07,,2014-07-31,2021-08,2021-08-31,2021-01,ACTUAL,2021-01-31,2020-05,ACTUAL,2020-05-31,,INTERVENTIONAL,,,Bupropion-Enhanced Contingency Management (CM) for Cocaine Dependence,Bupropion-Enhanced CM for Cocaine Dependence,COMPLETED,,PHASE2/PHASE3,83.0,ACTUAL,Johns Hopkins University,,4.0,,,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,OTHER,,,,,,,2021,1.0
NCT05961696,,2023-07-18,,,2023-10-06,2023-07-18,2023-07-27,ACTUAL,,,,,,,2023-10-06,2023-10-10,ACTUAL,2023-07-05,ACTUAL,2023-07-05,2023-10,2023-10-31,2023-10-03,ACTUAL,2023-10-03,2023-10-03,ACTUAL,2023-10-03,,INTERVENTIONAL,,,A Phase I Study of Mosunetuzumab for Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia,A Phase I Study of Mosunetuzumab for Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia,WITHDRAWN,,PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,0 accrual,,,,,t,t,f,,,,,,,,,,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,OTHER,,,,,,,2023,0.0
NCT03696212,,2018-10-03,,,2021-02-19,2018-10-03,2018-10-04,ACTUAL,,,,,,,2021-02-19,2021-02-21,ACTUAL,2019-01-08,ACTUAL,2019-01-08,2021-02,2021-02-28,2021-02-15,ACTUAL,2021-02-15,2021-02-15,ACTUAL,2021-02-15,,INTERVENTIONAL,,,Grapiprant (ARY-007) and Pembrolizumab in Patients With Advanced or Metastatic Post-PD-1/L1 NSCLC Adenocarcinoma,"Open Label, Single Arm, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Grapiprant (ARY-007) in Combination With Pembrolizumab in Patients With Advanced or Metastatic Post-PD-1/L1 Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma",TERMINATED,,PHASE1/PHASE2,18.0,ACTUAL,Arrys Therapeutics,,1.0,,"Based on the totality of the generated combined safety and efficacy data in the interim period, the company decided to terminate the combination study in NSCLC patients. There are no subjects on study drug at this time or in the EOT Follow-up period.",f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,INDUSTRY,,,,,,,2021,0.0
NCT03395288,,2017-12-28,2021-05-12,,2022-01-07,2018-01-03,2018-01-10,ACTUAL,2022-01-07,2022-02-04,ACTUAL,,,,2022-01-07,2022-02-04,ACTUAL,2018-03-22,ACTUAL,2018-03-22,2022-01,2022-01-31,2020-04-25,ACTUAL,2020-04-25,2020-04-25,ACTUAL,2020-04-25,,INTERVENTIONAL,,,Nutraceutical Efficacy for rUTI,"Randomized, Controlled Trial to Determine the Efficacy of Nutraceutical vs Control as Non-antibiotic Prophylaxis for Recurrent Urinary Tract Infection in Postmenopausal Women Using Vaginal Estrogen Therapy",TERMINATED,,PHASE2/PHASE3,61.0,ACTUAL,Washington University School of Medicine,The primary limitation of this study was the low recruitment and retention encountered. Study retention was lower than expected. A futility analysis was performed at the interim analysis and we found that we do not have power to detect the effect size difference that we originally estimated.,3.0,,Performed a futility analysis and determined that study objectives could not be met.,f,,,,t,t,f,,,,,,,,,NO,There is no plan to share individual participant data,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,OTHER,,,,,,,2020,0.0
NCT04042506,,2019-07-31,,,2021-04-07,2019-08-01,2019-08-02,ACTUAL,,,,,,,2021-04-07,2021-04-12,ACTUAL,2019-11-26,ACTUAL,2019-11-26,2020-04,2020-04-30,2021-01-26,ACTUAL,2021-01-26,2019-11-26,ACTUAL,2019-11-26,,INTERVENTIONAL,,,SBRT as a Vaccination for Metastatic Melanoma,In Situ Vaccination With Stereotactic Body Radiation Therapy (SBRT) as a Strategy to Overcome Resistance to Immune Checkpoint Blockade: a Phase II Clinical Trial of SBRT and Anti-PD-1 Therapy With Immunologic Correlates,WITHDRAWN,,PHASE2,0.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,Unable to enroll patients in this study,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,OTHER,,,,,,,2021,0.0
NCT03477006,,2018-03-19,2021-09-04,,2021-09-09,2018-03-19,2018-03-26,ACTUAL,2021-09-09,2021-10-06,ACTUAL,,,,2021-09-09,2021-10-06,ACTUAL,2018-11-20,ACTUAL,2018-11-20,2021-09,2021-09-30,2020-10-30,ACTUAL,2020-10-30,2020-10-30,ACTUAL,2020-10-30,,INTERVENTIONAL,PPOWER,,Pragmatic Prehospital Group O Whole Blood Early Resuscitation Trial,"Pragmatic Prehospital Group O Whole Blood Early Resuscitation (PPOWER) Trial: A Prospective, Interventional,Randomized, 3 Year, Pilot Clinical Trial",TERMINATED,,PHASE3,86.0,ACTUAL,University of Pittsburgh,,2.0,,"Slow enrollment, financial considerations and global pandemic",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,OTHER,,,,,,,2020,0.0
NCT04752566,,2021-02-09,2023-06-06,,2023-06-06,2021-02-09,2021-02-12,ACTUAL,2023-06-06,2024-02-09,ACTUAL,,,,2023-06-06,2024-02-09,ACTUAL,2021-03-08,ACTUAL,2021-03-08,2023-05,2023-05-31,2022-08-03,ACTUAL,2022-08-03,2022-08-03,ACTUAL,2022-08-03,,INTERVENTIONAL,,Full analysis set included all randomized participants who received at least 1 dose of study drug and had a baseline functional grade (FG) score and at least 1 postbaseline FG score.,A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome,"A Phase 3, Prospective, Multicenter, Double Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Eculizumab in Patients With Guillain-Barré Syndrome (GBS)",COMPLETED,,PHASE3,57.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,INDUSTRY,,,,,,,2022,1.0
NCT04158141,,2019-11-05,,,2024-09-18,2019-11-06,2019-11-08,ACTUAL,,,,,,,2024-09-18,2024-09-20,ACTUAL,2020-01-29,ACTUAL,2020-01-29,2024-09,2024-09-30,2023-11-20,ACTUAL,2023-11-20,2023-11-20,ACTUAL,2023-11-20,,INTERVENTIONAL,,,Testing the Addition of Targeted Radiation Therapy to Surgery and the Usual Chemotherapy Treatment (Pemetrexed and Cisplatin [or Carboplatin]) for Stage I-IIIA Malignant Pleural Mesothelioma,Phase III Randomized Trial of Pleurectomy/Decortication Plus Systemic Therapy With or Without Adjuvant Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for Malignant Pleural Mesothelioma (MPM),TERMINATED,,PHASE3,16.0,ACTUAL,NRG Oncology,,2.0,,Permanent Administrative Closure,f,,,,t,t,f,,,,,,,,,,,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,OTHER,,,,,,,2023,0.0
NCT03170518,,2017-05-26,,2024-09-18,2024-09-19,2017-05-26,2017-05-31,ACTUAL,,,,,2024-09-19,ACTUAL,2024-09-19,2024-09-23,ACTUAL,2017-07-21,ACTUAL,2017-07-21,2024-09,2024-09-30,2023-09-20,ACTUAL,2023-09-20,2023-09-20,ACTUAL,2023-09-20,,INTERVENTIONAL,,,A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus,"A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (≥10 to <18 Years) With Type 2 Diabetes Mellitus",COMPLETED,,PHASE3,171.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,INDUSTRY,,,,,,,2023,0.0
NCT02595918,,2015-11-03,,,2020-10-22,2015-11-03,2015-11-04,ESTIMATED,,,,,,,2020-10-22,2020-10-23,ACTUAL,2016-05-19,ACTUAL,2016-05-19,2020-10,2020-10-31,2020-08-01,ACTUAL,2020-08-01,2020-08-01,ACTUAL,2020-08-01,,INTERVENTIONAL,,,Nivolumab in Treating Patients With High-Risk Kidney Cancer Before Surgery,A Pilot Study of Preoperative Nivolumab in High-Risk Non-Metastatic and Metastatic Renal Cell Carcinoma,TERMINATED,,PHASE1,19.0,ACTUAL,National Cancer Institute (NCI),,1.0,,Inadequate accrual rate,f,,,,t,t,f,,,,,,,,,,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,NIH,,,,,,,2020,0.0
NCT03354598,,2017-11-20,2020-11-20,,2020-12-17,2017-11-25,2017-11-28,ACTUAL,2020-11-20,2020-12-17,ACTUAL,,,,2020-12-17,2021-01-12,ACTUAL,2018-08-01,ACTUAL,2018-08-01,2019-12,2019-12-31,2020-01-20,ACTUAL,2020-01-20,2020-01-16,ACTUAL,2020-01-16,,INTERVENTIONAL,,Intent to Treat (ITT) Participants,Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women,A Prospective Phase 3 Randomized Multi-center Double-blind Study of Efficacy Tolerability & Safety of Oral Sulopenem-etzadroxil/Probenecid vs Ciprofloxacin for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women,COMPLETED,,PHASE3,1671.0,ACTUAL,"Iterum Therapeutics, International Limited",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,INDUSTRY,,,,,,,2020,1.0
NCT03312244,,2017-04-01,,,2020-04-08,2017-10-16,2017-10-17,ACTUAL,,,,,,,2020-04-08,2020-04-10,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2020-04,2020-04-30,2022-06-30,ESTIMATED,2022-06-30,2021-06-30,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,Pyridostigmine as Immunomodulator in People Living With HIV,Study of the Role of Peripheral Acetylcholinesterase Inhibitor Pyridostigmine as Immunomodulators in a Population of Patients Living With Human Immunodeficiency Virus Infection.,SUSPENDED,,PHASE2,60.0,ESTIMATED,Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran,,2.0,,"Due to COVID-19, effective 3/19/2020 recruitment is halted until further notice",f,,,,t,f,f,,,f,,,Data will be available after finishing with recruitment.,Data will be made available by request.,,YES,All data will be freely available to all research parties involved,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,OTHER,,,,,,,2022,0.0
NCT04140695,,2019-10-24,2024-04-01,,2024-04-23,2019-10-24,2019-10-28,ACTUAL,2024-04-23,2024-05-14,ACTUAL,,,,2024-04-23,2024-05-14,ACTUAL,2019-10-21,ACTUAL,2019-10-21,2024-04,2024-04-30,2020-10-14,ACTUAL,2020-10-14,2020-10-14,ACTUAL,2020-10-14,,INTERVENTIONAL,,,Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2),"A Randomized, Double-blind, Placebo-controlled, Efficacy Study of the Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis",TERMINATED,,PHASE3,87.0,ACTUAL,Vanda Pharmaceuticals,This study was discontinued early and therefore the study was not powered for appropriate examination of primary and secondary endpoints.,2.0,,Business Decision,f,,,,,t,f,,,,,,,,,,,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,INDUSTRY,,,,,,,2020,0.0
NCT03433833,,2018-02-08,,,2024-09-18,2018-02-08,2018-02-15,ACTUAL,,,,,,,2024-09-18,2024-09-20,ACTUAL,2019-11-10,ACTUAL,2019-11-10,2024-09,2024-09-30,2024-12-31,ESTIMATED,2024-12-31,2024-04-16,ACTUAL,2024-04-16,,INTERVENTIONAL,,,Digoxin for Congenital Erythrocytosis Due to Up-Regulated Hypoxia Sensing,Phase 1 Study of Digoxin for Congenital Erythrocytosis Due to Up-Regulated Hypoxia Sensing,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Illinois at Chicago,,1.0,,Study Not Funded,f,,,,t,t,f,,,f,,,,,,NO,The research data will be shared with the co-investigators and the referring physicians.,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,OTHER,,,,,,,2024,0.0
NCT05641298,,2022-11-29,,,2023-07-17,2022-11-29,2022-12-07,ACTUAL,,,,,,,2023-07-17,2023-07-19,ACTUAL,2023-02-10,ACTUAL,2023-02-10,2023-02,2023-02-28,2023-09,ESTIMATED,2023-09-30,2023-09,ESTIMATED,2023-09-30,,INTERVENTIONAL,REPRIEVE,,Study to Determine the Efficacy&Safety of ARV-1801(ACG-701) for the Treatment of Cystic Fibrosis Pulmonary Exacerbations,"A Phase 2, Randomized, DB, Placebo-controlled Study to Determine the Efficacy, Safety and PK Profile of ARV-1801 in Combination With Optimized Background Therapy for the Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis",WITHDRAWN,,PHASE2,0.0,ACTUAL,Aceragen,,2.0,,Corporate finances,f,,,,t,t,f,,,,,,,,,,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,INDUSTRY,,,,,,,2023,0.0
NCT04594681,,2020-09-22,,,2023-05-16,2020-10-14,2020-10-20,ACTUAL,,,,,,,2023-05-16,2023-05-18,ACTUAL,2020-09-16,ACTUAL,2020-09-16,2023-05,2023-05-31,2022-08-26,ACTUAL,2022-08-26,2022-08-26,ACTUAL,2022-08-26,,INTERVENTIONAL,,,A Safety Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration,A Phase I Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration,TERMINATED,,PHASE1,116.0,ACTUAL,"Kyowa Kirin Co., Ltd.",,2.0,,"The Sponsor judged that the objectives of this Phase 1 study were satisfied, and the study was terminated after the completion of Cohort 3 Step 3.",f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,INDUSTRY,,,,,,,2022,0.0
NCT03317002,,2017-10-05,2021-03-30,,2021-06-29,2017-10-17,2017-10-23,ACTUAL,2021-06-29,2021-06-30,ACTUAL,,,,2021-06-29,2021-06-30,ACTUAL,2017-10-30,ACTUAL,2017-10-30,2021-06,2021-06-30,2020-04-08,ACTUAL,2020-04-08,2020-04-08,ACTUAL,2020-04-08,,INTERVENTIONAL,FLAVOUR,,"AZD5718 Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 in Patients With Coronary Artery Disease (CAD).","A 12-week, Randomized, Single-blind, Placebo-controlled, Multi-centre, Parallel Group, Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 After 4 and 12-weeks of Treatment in Patients With Coronary Artery Disease (CAD)",COMPLETED,,PHASE2,129.0,ACTUAL,AstraZeneca,,3.0,,,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,INDUSTRY,,,,,,,2020,1.0
NCT04526288,,2020-08-21,2024-02-06,,2024-04-29,2020-08-21,2020-08-25,ACTUAL,2024-04-29,2024-05-23,ACTUAL,,,,2024-04-29,2024-05-23,ACTUAL,2021-08-09,ACTUAL,2021-08-09,2024-04,2024-04-30,2023-08-27,ACTUAL,2023-08-27,2023-08-27,ACTUAL,2023-08-27,,INTERVENTIONAL,,Single Arm A participant followed for survival only.,CPX-351 Versus Immediate Stem Cell Transplantation for the Treatment of High-Grade Myeloid Cancers With Measurable Residual Disease,A Randomized Trial for Patients With High-Grade Myeloid Neoplasms With Measurable Residual Disease (MRD): CPX-351 vs. Immediate Allogeneic Hematopoietic Cell Transplantation,TERMINATED,,PHASE2,1.0,ACTUAL,Fred Hutchinson Cancer Center,"Low accrual lead to early termination of the study. The single individual enrolled was randomized to the non-investigational arm of the study (Arm A) and was removed from the study prior to conditioning which only allowed for follow-up of overall survival. Therefore, there is little to no interpretable data to report.",2.0,,Terminated due to low accrual,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,OTHER,,,,,,,2023,0.0
NCT04524962,,2020-08-19,,,2024-06-12,2020-08-20,2020-08-24,ACTUAL,,,,,,,2024-06-12,2024-06-14,ACTUAL,2021-02-23,ACTUAL,2021-02-23,2024-06,2024-06-30,2023-09-09,ACTUAL,2023-09-09,2022-09-09,ACTUAL,2022-09-09,,INTERVENTIONAL,,,Study of Descartes-30 in Acute Respiratory Distress Syndrome,Phase I/IIA Study of Descartes-30 in Acute Respiratory Distress Syndrome,TERMINATED,,PHASE1,12.0,ACTUAL,Cartesian Therapeutics,,1.0,,Phase 1 enrollment completed. Further clinical development terminated,f,,,,f,t,f,,,,,,,,,,,2024-10-16 10:10:04.261258,2024-10-16 10:10:04.261258,INDUSTRY,,,,,,,2023,0.0
NCT04315298,,2020-03-15,2021-07-23,,2021-09-16,2020-03-17,2020-03-19,ACTUAL,2021-09-16,2021-09-23,ACTUAL,,,,2021-09-16,2021-09-23,ACTUAL,2020-03-18,ACTUAL,2020-03-18,2021-09,2021-09-30,2020-09-02,ACTUAL,2020-09-02,2020-07-24,ACTUAL,2020-07-24,,INTERVENTIONAL,,,Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19,"An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID-19",COMPLETED,,PHASE2/PHASE3,1912.0,ACTUAL,Regeneron Pharmaceuticals,,6.0,,,f,,,,t,t,f,,,,,,"Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification","Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, EMA, PMDA, etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).",https://vivli.org/,YES,All IPD that underlie publicly available results will be considered for sharing,2024-10-16 10:10:04.261258,2024-10-16 10:10:04.261258,INDUSTRY,,,,,,,2020,1.0
NCT04676061,,2020-12-11,,,2024-01-31,2020-12-17,2020-12-19,ACTUAL,,,,,,,2024-01-31,2024-02-02,ACTUAL,2021-02-11,ACTUAL,2021-02-11,2023-03,2023-03-31,2023-03-10,ACTUAL,2023-03-10,2022-07-18,ACTUAL,2022-07-18,,INTERVENTIONAL,,,Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™,Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™; a Randomized Double-Blinded Placebo-Controlled Trial,TERMINATED,,PHASE4,51.0,ACTUAL,Baylor Research Institute,,2.0,,It was in the best interest of the investigator to terminate the study earlier than anticipated.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,OTHER,,,,,,,2023,0.0
NCT03952832,,2019-02-01,,,2019-11-12,2019-05-15,2019-05-16,ACTUAL,,,,,,,2019-11-12,2019-11-14,ACTUAL,2019-12-11,ESTIMATED,2019-12-11,2019-11,2019-11-30,2021-06-11,ESTIMATED,2021-06-11,2021-06-11,ESTIMATED,2021-06-11,,INTERVENTIONAL,,,Leflunomide in Treating Patients With High-Risk Smoldering Multiple Myeloma,Phase 2 Trial of Leflunomide in Patients With High-Risk Smoldering Multiple Myeloma,WITHDRAWN,,PHASE2,0.0,ACTUAL,City of Hope Medical Center,,1.0,,Budget issues,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,OTHER,,,,,,,2021,0.0
NCT03238300,,2017-07-31,2023-04-17,,2023-06-20,2017-08-02,2017-08-03,ACTUAL,2023-06-20,2023-06-22,ACTUAL,,,,2023-06-20,2023-06-22,ACTUAL,2017-10-16,ACTUAL,2017-10-16,2023-06,2023-06-30,2022-03-01,ACTUAL,2022-03-01,2022-03-01,ACTUAL,2022-03-01,,INTERVENTIONAL,,,Neuroscience-Informed Treatment Development for Adolescent Alcohol Use,Neuroscience-Informed Treatment Development for Adolescent Alcohol Use,COMPLETED,,PHASE2,57.0,ACTUAL,Medical University of South Carolina,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,OTHER,,,,,,,2022,1.0
NCT03802864,,2019-01-04,2020-10-26,,2020-11-23,2019-01-10,2019-01-14,ACTUAL,2020-11-23,2020-12-17,ACTUAL,,,,2020-11-23,2020-12-17,ACTUAL,2019-02-04,ACTUAL,2019-02-04,2020-11,2020-11-30,2020-01-30,ACTUAL,2020-01-30,2020-01-30,ACTUAL,2020-01-30,,INTERVENTIONAL,,,Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine,Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine,COMPLETED,,PHASE4,50.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,OTHER,,,,,,,2020,1.0
NCT03685591,,2018-09-20,2023-03-16,,2024-06-24,2018-09-25,2018-09-26,ACTUAL,2024-06-24,2024-06-26,ACTUAL,,,,2024-06-24,2024-06-26,ACTUAL,2018-10-04,ACTUAL,2018-10-04,2024-06,2024-06-30,2022-03-30,ACTUAL,2022-03-30,2022-03-30,ACTUAL,2022-03-30,,INTERVENTIONAL,,All enrolled participants who received at least one dose of study treatment.,PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors,"A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF 06952229 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS",TERMINATED,,PHASE1,49.0,ACTUAL,Pfizer,"The trial began on 04 October 2018 with LPLV occurring on 30 March 2022 following Pfizer's strategic decision (not due to any specific safety reasons or request from a regulatory authority) to terminate the study, which included the period during which the COVID-19 pandemic was occurring globally since 11 March 2020.",15.0,,The decision to stop enrollment was due to strategic considerations and not due to any specific safety reasons or request from a regulatory authority.,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,INDUSTRY,,,,,,,2022,0.0
NCT04750473,,2021-02-09,,,2024-09-05,2021-02-09,2021-02-11,ACTUAL,,,,,,,2024-09-05,2024-09-19,ACTUAL,2021-07-16,ACTUAL,2021-07-16,2024-09,2024-09-30,2024-03-21,ACTUAL,2024-03-21,2023-03-21,ACTUAL,2023-03-21,,INTERVENTIONAL,,,Fluciclovine and PSMA PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer,Phase 1 Feasibility Trial: Improved Staging of Lobular Breast Cancer With Novel Amino Acid Metabolic and Tumor Neovasculature Receptor Imaging,COMPLETED,,PHASE1,22.0,ACTUAL,Emory University,,1.0,,,,,,,t,t,f,,,f,,,,,,,,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,OTHER,,,,,,,2024,1.0
NCT02659761,,2016-01-08,,,2024-05-07,2016-01-15,2016-01-20,ESTIMATED,,,,,,,2024-05-07,2024-05-09,ACTUAL,2016-11,ACTUAL,2016-11-30,2024-05,2024-05-31,2021-09,ACTUAL,2021-09-30,2021-09,ACTUAL,2021-09-30,,INTERVENTIONAL,TAISTR,,Triumeq As an Integrase Single Tablet Regimen in People With HIV Who Inject Drugs,"A Prospective, Single Arm, Open-label 96 Week Observational Trial of the Tolerability, Adherence and Efficacy of a Dolutegravir/Abacavir/Lamivudine Single Tablet Regimen in HIV-1 Antibody Positive People Living With HIV With a History of Injection Drug Use Switching From Existing ART or Starting Treatment After Discontinuation of ART",TERMINATED,,PHASE4,33.0,ACTUAL,University College Dublin,,1.0,,Sponsor decision due to slow recruitment rates and no future recruitment foreseen,f,,,,t,,,,,,,,,,,,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,OTHER,,,,,,,2021,0.0
NCT02856113,,2016-08-02,2022-07-29,,2022-10-14,2016-08-02,2016-08-04,ESTIMATED,2022-10-14,2022-10-19,ACTUAL,,,,2022-10-14,2022-10-19,ACTUAL,2016-10-14,ACTUAL,2016-10-14,2022-10,2022-10-31,2022-02-14,ACTUAL,2022-02-14,2021-08-06,ACTUAL,2021-08-06,,INTERVENTIONAL,,Safety Set included all participants who took at least 1 dose of study medication.,Phase 3 Alogliptin Pediatric Study,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alogliptin Compared With Placebo in Pediatric Subjects With Type 2 Diabetes Mellitus",COMPLETED,,PHASE3,152.0,ACTUAL,Takeda,,2.0,,,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect Participant privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,INDUSTRY,,,,,,,2022,1.0
NCT04322305,,2020-03-24,,,2024-09-20,2020-03-24,2020-03-26,ACTUAL,,,,,,,2024-09-20,2024-09-23,ACTUAL,2021-01-11,ACTUAL,2021-01-11,2024-09,2024-09-30,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,GABI2,,Pregabalin Trial for the Treatment of Alcohol Use Disorder,"A Double-blind, Placebo-Controlled Trial of Pregabalin for the Treatment of Alcohol Use Disorder",SUSPENDED,,PHASE2,50.0,ESTIMATED,New York State Psychiatric Institute,,2.0,,"U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume recruitment after OHRP has approved the resumption of research.",f,,,,t,t,f,,,t,,,beginning 12 months and ending 5 years after article publication,to researcher who provides a methodologically sound proposal to achieve aims in the approved proposal,,YES,"Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures)",2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,OTHER,,,,,,,2024,0.0
NCT04341493,,2020-04-07,,,2021-03-29,2020-04-07,2020-04-10,ACTUAL,,,,,,,2021-03-29,2021-04-01,ACTUAL,2020-04-06,ACTUAL,2020-04-06,2021-03,2021-03-31,2020-12-30,ACTUAL,2020-12-30,2020-08-30,ACTUAL,2020-08-30,,INTERVENTIONAL,,,Hydroxychloroquine vs Nitazoxanide in Patients With COVID-19,Treatment With Hydroxychloroquine vs Nitazoxanide + Hydroxychloroquine in Patients With COVID-19 With Risk Factors for Poor Outcome,TERMINATED,,PHASE4,44.0,ACTUAL,Materno-Perinatal Hospital of the State of Mexico,,2.0,,Concerns about safety of Hydroxychloroquine,f,,,,f,f,f,,,,,,After finishing the study.,Requested by the journal or after publication if any researcher in the world express interest if the information of this survey.,,YES,"If the final selected medical journal to send the paper of our research request it, we will add the full database of the studied population.",2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,OTHER,,,,,,,2020,0.0
NCT05733390,,2023-02-08,,,2023-12-19,2023-02-08,2023-02-17,ACTUAL,,,,,,,2023-12-19,2023-12-22,ACTUAL,2023-06-30,ACTUAL,2023-06-30,2023-12,2023-12-31,2023-11-09,ACTUAL,2023-11-09,2023-11-09,ACTUAL,2023-11-09,,INTERVENTIONAL,,,A Study of JZP541 in Adults With Irritability Associated With Autism Spectrum Disorder,"A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of JZP541 in Adults With Irritability Associated With Autism Spectrum Disorder",TERMINATED,,PHASE2,1.0,ACTUAL,Jazz Pharmaceuticals,,2.0,,A decision has been made to prioritize other pipeline programs and terminate this study.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,INDUSTRY,,,,,,,2023,0.0
NCT02408861,,2015-04-03,,,2024-09-20,2015-04-03,2015-04-06,ESTIMATED,,,,,,,2024-09-20,2024-09-23,ACTUAL,2015-10-21,ACTUAL,2015-10-21,2024-09,2024-09-30,2024-08-31,ACTUAL,2024-08-31,2024-05-01,ACTUAL,2024-05-01,,INTERVENTIONAL,,,Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery,A Phase I Study of Ipilimumab and Nivolumab in Advanced HIV Associated Solid Tumors With an Expansion Cohort in HIV Associated Solid Tumors and a Cohort of HIV-Associated Classical Hodgkin Lymphoma,TERMINATED,,PHASE1,95.0,ACTUAL,National Cancer Institute (NCI),,1.0,,Inadequate accrual rate,f,,,,f,,,,,,,,,,,,,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,NIH,,,,,,,2024,0.0
NCT02245230,,2014-09-17,,,2024-01-08,2014-09-18,2014-09-19,ESTIMATED,,,,,,,2024-01-08,2024-01-09,ACTUAL,2015-01,ACTUAL,2015-01-31,2024-01,2024-01-31,2023-12,ACTUAL,2023-12-31,2023-12,ACTUAL,2023-12-31,,INTERVENTIONAL,,,Cardiovascular Effects of Angiotensin (1-7) in Essential Hypertension,Cardiovascular Effects of Angiotensin (1-7) in Essential Hypertension,TERMINATED,,PHASE1,24.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,"We were not able to enroll adequate number of participants that met the inclusion/exclusion criteria, and we run out of funding.",f,,,,t,,,,,,,,,,,NO,,2024-10-16 10:10:04.261258,2024-10-16 10:10:04.261258,OTHER,,,,,,,2023,0.0
NCT05276830,,2022-02-28,2023-08-02,,2023-08-24,2022-03-09,2022-03-11,ACTUAL,2023-08-24,2023-08-25,ACTUAL,,,,2023-08-24,2023-08-25,ACTUAL,2022-02-08,ACTUAL,2022-02-08,2023-08,2023-08-31,2022-04-01,ACTUAL,2022-04-01,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,,,"An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of BXCL501 For The Treatment of Agitation Associated With Dementia",TERMINATED,,PHASE2,5.0,ACTUAL,BioXcel Therapeutics Inc,The study was terminated prematurely due to business reasons. There were no Safety or Efficacy Concerns.,3.0,,Study was terminated for business reasons; not due to safety or efficacy concerns,f,,,,f,t,f,,,,,,,,,,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,INDUSTRY,,,,,,,2022,0.0
NCT04918069,,2021-06-02,,,2022-05-14,2021-06-02,2021-06-08,ACTUAL,,,,,,,2022-05-14,2022-05-20,ACTUAL,2019-10-18,ACTUAL,2019-10-18,2022-05,2022-05-31,2022-05-14,ACTUAL,2022-05-14,2022-05-14,ACTUAL,2022-05-14,,INTERVENTIONAL,CapCIN,,Capsaicin to Prevent Delayed Chemotherapy Induced Nausea and Vomiting (CapCIN),"Single-blinded, Randomized Study of Capsaicin to Prevent Delayed Chemotherapy-induced Nausea and Vomiting",COMPLETED,,PHASE2,160.0,ACTUAL,"Christian Medical College, Vellore, India",,2.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,IPD may be shared depending on prevailing local institutional policies.,2024-10-16 10:10:04.261258,2024-10-16 10:10:04.261258,OTHER,,,,,,,2022,1.0
NCT01590225,,2012-05-01,,,2021-01-26,2012-05-01,2012-05-02,ESTIMATED,,,,,,,2021-01-26,2021-01-29,ACTUAL,2013-01-28,ACTUAL,2013-01-28,2021-01,2021-01-31,2021-08-18,ESTIMATED,2021-08-18,2021-08-18,ESTIMATED,2021-08-18,,INTERVENTIONAL,,,Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034),A Phase 3 Study to Assess the Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1,WITHDRAWN,,PHASE3,0.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,INDUSTRY,,,,,,,2021,0.0
NCT01743989,,2012-12-04,2021-06-23,,2021-06-23,2012-12-05,2012-12-06,ESTIMATED,2021-06-23,2021-07-15,ACTUAL,,,,2021-06-23,2021-07-15,ACTUAL,2013-04-15,ACTUAL,2013-04-15,2021-06,2021-06-30,2020-07-08,ACTUAL,2020-07-08,2020-07-08,ACTUAL,2020-07-08,,INTERVENTIONAL,ENESTPath,,A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.,"A Prospective, Randomized, Open Label, Two Arm Phase III Study to Evaluate Treatment Free Remission (TFR) Rate in Patients With Philadelphia-positive CML After Two Different Durations of Consolidation Treatment With Nilotinib 300mg BID.",COMPLETED,,PHASE3,620.0,ACTUAL,Novartis,,3.0,,,f,,,,t,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,INDUSTRY,,,,,,,2020,1.0
NCT04178460,,2019-11-25,,,2022-05-25,2019-11-25,2019-11-26,ACTUAL,,,,,,,2022-05-25,2022-06-01,ACTUAL,2020-02-03,ACTUAL,2020-02-03,2022-05,2022-05-31,2022-03-02,ACTUAL,2022-03-02,2022-03-02,ACTUAL,2022-03-02,,INTERVENTIONAL,,,A Study of Niraparib Combined With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment,"A Multicenter, Open-label, Single-arm, Phase Ib Dose Escalation and Multi-cohort Expansion Clinical Study to Assess the Safety and Antitumor Activity of Niraparib in Combination With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment",TERMINATED,,PHASE1,60.0,ACTUAL,"Zai Lab (Hong Kong), Ltd.",,1.0,,This termination decision is a business decision and is not due to any safety concerns.,f,,,,t,f,f,,,,,,,,,,,2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,INDUSTRY,,,,,,,2022,0.0
NCT04455620,,2020-06-29,,,2024-06-25,2020-06-29,2020-07-02,ACTUAL,,,,,,,2024-06-25,2024-06-26,ACTUAL,2021-01-26,ACTUAL,2021-01-26,2024-06,2024-06-30,2024-05-28,ACTUAL,2024-05-28,2024-05-28,ACTUAL,2024-05-28,,INTERVENTIONAL,,,BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors,"Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors",TERMINATED,,PHASE1/PHASE2,62.0,ACTUAL,BioNTech SE,,1.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:16:33.466912,2024-10-16 00:16:33.466912,INDUSTRY,,,,,,,2024,0.0
NCT03817931,,2019-01-24,,,2024-01-31,2019-01-24,2019-01-28,ACTUAL,,,,,,,2024-01-31,2024-02-02,ACTUAL,2019-08-05,ACTUAL,2019-08-05,2019-08,2019-08-31,2022-02-26,ACTUAL,2022-02-26,2022-02-02,ACTUAL,2022-02-02,,INTERVENTIONAL,,,"Higher Neural Changes Following Anticholinergic, Beta 3 Agonist, or Placebo in Patients With Overactive Bladder",Higher Neural and Cognitive Changes Following Anticholinergic Versus Beta 3 Agonist Versus Placebo Treatments in Female Patients With Overactive Bladder: a Multicenter Randomized Controlled Pilot Trial,COMPLETED,,PHASE4,12.0,ACTUAL,Baylor Research Institute,,3.0,,,f,,,,t,t,f,,,t,,,,,,NO,There is not a plan.,2024-10-16 10:10:04.261258,2024-10-16 10:10:04.261258,OTHER,,,,,,,2022,0.0
NCT01995513,,2013-11-18,2017-10-13,,2023-08-22,2013-11-21,2013-11-26,ESTIMATED,2017-10-17,2017-11-17,ACTUAL,,,,2023-08-22,2023-09-18,ACTUAL,2013-10-22,ACTUAL,2013-10-22,2023-08,2023-08-31,2022-08-31,ACTUAL,2022-08-31,2016-11-15,ACTUAL,2016-11-15,,INTERVENTIONAL,PLATO,ITT (Intent to treat) population included all participants randomly assigned to study treatment.,Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients,"A PHASE 4, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CONTINUED ENZALUTAMIDE TREATMENT BEYOND PROGRESSION IN PATIENTS WITH CHEMOTHERAPY-NAÏVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER",COMPLETED,,PHASE4,509.0,ACTUAL,Pfizer,,2.0,,,f,,,,f,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 20:53:48.02213,2024-10-16 20:53:48.02213,INDUSTRY,,,,,,,2022,1.0
NCT04807972,,2021-03-17,,,2024-09-19,2021-03-17,2021-03-19,ACTUAL,,,,,,,2024-09-19,2024-09-23,ACTUAL,2021-05-28,ACTUAL,2021-05-28,2024-05,2024-05-31,2024-03-25,ACTUAL,2024-03-25,2024-03-25,ACTUAL,2024-03-25,,INTERVENTIONAL,,,Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis,"A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination With Modified FOLFIRINOX (mFFX) With or Without Budigalimab Compared to mFFX in Subjects With Untreated Metastatic Pancreatic Adenocarcinoma",TERMINATED,,PHASE1/PHASE2,40.0,ACTUAL,AbbVie,,4.0,,Strategic considerations,f,,,,t,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,INDUSTRY,,,,,,,2024,0.0
NCT05582707,,2022-10-03,,,2024-09-19,2022-10-12,2022-10-17,ACTUAL,,,,,,,2024-09-19,2024-09-23,ACTUAL,2023-05-08,ACTUAL,2023-05-08,2024-09,2024-09-30,2024-09-19,ACTUAL,2024-09-19,2024-09-19,ACTUAL,2024-09-19,,INTERVENTIONAL,ENRICHPLUS,,Safety and Suitability of Supplementing Early MIP Surgery (MIPS) of ICH With Pioglitazone,A Non-Randomized Controlled Trial to Examine the Safety and Suitability of Supplementing Early Minimally Invasive Parafascicular Surgery (MIPS) for Clot Evacuation of Basal Ganglia Intracerebral Hemorrhage (ICH) With Pioglitazone,TERMINATED,,PHASE2,1.0,ACTUAL,"University of Maryland, Baltimore",,2.0,,Loss of Financial Sponsor,f,,,,t,t,f,,,,,,,,,,,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,OTHER,,,,,,,2024,0.0
NCT05487040,,2022-08-02,2024-05-28,,2024-05-28,2022-08-02,2022-08-04,ACTUAL,2024-05-28,2024-09-23,ACTUAL,,,,2024-05-28,2024-09-23,ACTUAL,2022-09-07,ACTUAL,2022-09-07,2024-05,2024-05-31,2023-07-11,ACTUAL,2023-07-11,2023-07-11,ACTUAL,2023-07-11,,INTERVENTIONAL,,The baseline population was the safety analysis set (SAS) which was all participants enrolled and took at least 1 dose of study intervention.,A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease,"A PHASE 1, OPEN-LABEL, NON-RANDOMIZED STUDY TO INVESTIGATE THE SAFETY AND PK FOLLOWING MULTIPLE ORAL DOSES OF PF-07321332 (NIRMATRELVIR)/RITONAVIR IN ADULT PARTICIPANTS WITH COVID-19 AND SEVERE RENAL IMPAIRMENT EITHER ON HEMODIALYSIS OR NOT ON HEMODIALYSIS",TERMINATED,,PHASE1,15.0,ACTUAL,Pfizer,,2.0,,Decision to terminate study was due to slow enrolment and FDA input that available data may be enough for dosing recommendations for severe renal disease (subject to review by FDA).,f,,,,,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,INDUSTRY,,,,,,,2023,0.0
NCT01455389,,2011-10-17,,,2022-02-11,2011-10-17,2011-10-20,ESTIMATED,,,,,,,2022-02-11,2022-03-02,ACTUAL,2014-02,ACTUAL,2014-02-28,2022-02,2022-02-28,2020-09-28,ACTUAL,2020-09-28,2016-10-27,ACTUAL,2016-10-27,,INTERVENTIONAL,,,TUSC2-nanoparticles and Erlotinib in Stage IV Lung Cancer,Phase I/II Clinical Trial Combining TUSC2-nanoparticles and Erlotinib in Stage IV Lung Cancer,TERMINATED,,PHASE1/PHASE2,25.0,ACTUAL,"Genprex, Inc.",,1.0,,Trial terminated by sponsor after decision to evaluate combination of quaratusugene ozeplasmid and osimertinib instead of further evaluating quaratusugene ozeplasmid and erlotinib.,f,,,,f,,,,,,,,,,,,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,INDUSTRY,,,,,,,2020,0.0
NCT03352557,,2017-11-21,2022-08-26,,2022-10-18,2017-11-21,2017-11-24,ACTUAL,2022-10-18,2022-11-08,ACTUAL,,,,2022-10-18,2022-11-08,ACTUAL,2018-05-03,ACTUAL,2018-05-03,2022-10,2022-10-31,2021-08-30,ACTUAL,2021-08-30,2021-08-30,ACTUAL,2021-08-30,,INTERVENTIONAL,TANGO,Randomized participants included enrolled participants who received a randomization treatment assignment from the Interactive Response Technology (BIIB092 or placebo).,Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease,"Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of BIIB092 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease",TERMINATED,,PHASE2,654.0,ACTUAL,Biogen,The study was terminated based on lack of efficacy following the placebo-controlled period readout.,4.0,,The study (NCT03352557) was terminated based on lack of efficacy following the placebo-controlled period readout.,f,,,,t,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,INDUSTRY,,,,,,,2021,0.0
NCT02929589,,2016-10-04,2024-01-12,,2024-03-25,2016-10-07,2016-10-11,ESTIMATED,2024-03-25,2024-03-26,ACTUAL,,,,2024-03-25,2024-03-26,ACTUAL,2018-07-05,ACTUAL,2018-07-05,2024-03,2024-03-31,2021-08-23,ACTUAL,2021-08-23,2021-08-23,ACTUAL,2021-08-23,,INTERVENTIONAL,,Study was terminated before any subject data collected could be analyzed. Raw data are reported. No data collected was analyzed by a biostatistician.,Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy,"Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy: A Prospective, Placebo-Controlled, Double-Blind, Randomized Controlled Trial",TERMINATED,,PHASE3,18.0,ACTUAL,Mike O'Callaghan Military Hospital,This study was terminated early as the advent of the use of robotic surgery made this study obsolete.,4.0,,The use of robotic surgery made this study obsolete.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,FED,,,,,,,2021,0.0
NCT03710291,,2018-10-11,,,2022-10-13,2018-10-15,2018-10-18,ACTUAL,,,,,,,2022-10-13,2022-10-14,ACTUAL,2018-11-20,ACTUAL,2018-11-20,2022-10,2022-10-31,2022-09-27,ACTUAL,2022-09-27,2022-08-23,ACTUAL,2022-08-23,,INTERVENTIONAL,VALOR-CKD,,Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis,"A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis",TERMINATED,,PHASE3,1480.0,ACTUAL,"Tricida, Inc.",,2.0,,Administrative reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:10:04.261258,2024-10-16 10:10:04.261258,INDUSTRY,,,,,,,2022,0.0
NCT05312632,,2022-03-28,2024-05-23,,2024-05-23,2022-03-28,2022-04-05,ACTUAL,2024-05-23,2024-09-23,ACTUAL,,,,2024-05-23,2024-09-23,ACTUAL,2022-04-05,ACTUAL,2022-04-05,2023-10,2023-10-31,2023-05-25,ACTUAL,2023-05-25,2023-05-25,ACTUAL,2023-05-25,,INTERVENTIONAL,,The safety analysis population included participants who received at least 1 dose of study drug and completed at least 1 post-dose safety assessment.,A Study to Evaluate the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Participants With Motor Fluctuation in South Korea,"A Multi-center, Open-label Phase 4 Study Evaluating the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Patients With Motor Fluctuation in South Korea",COMPLETED,,PHASE4,201.0,ACTUAL,Eisai Inc.,,1.0,,,f,,,,f,f,f,,,,,,,,,YES,Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,INDUSTRY,,,,,,,2023,1.0
NCT04629703,,2020-11-13,,2023-08-15,2023-08-15,2020-11-13,2020-11-16,ACTUAL,,,,,2023-08-18,ACTUAL,2023-08-15,2023-08-18,ACTUAL,2021-03-25,ACTUAL,2021-03-25,2023-08,2023-08-31,2022-09-05,ACTUAL,2022-09-05,2022-09-05,ACTUAL,2022-09-05,,INTERVENTIONAL,,,"Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects","Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects",COMPLETED,,PHASE3,280.0,ACTUAL,Rigel Pharmaceuticals,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,INDUSTRY,,,,,,,2022,0.0
NCT04773067,,2021-02-23,,,2022-08-25,2021-02-24,2021-02-26,ACTUAL,,,,,,,2022-08-25,2022-08-26,ACTUAL,2021-01-30,ACTUAL,2021-01-30,2022-06,2022-06-30,2022-03-08,ACTUAL,2022-03-08,2022-03-08,ACTUAL,2022-03-08,,INTERVENTIONAL,,,"A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers","A Phase II, Placebo-controlled, Randomized, Observer-blind Study to Evaluate the Immunogenicity, Safety, and Tolerability of UB-612 Vaccine Against COVID-19 in Adolescent, Younger and Elderly Adult Volunteers",TERMINATED,,PHASE2,3877.0,ACTUAL,"United Biomedical Inc., Asia",,2.0,,"Under the limited resources, to re-plan the ongoing clinical trials of this product.",f,,,,t,f,f,,,,,,,,,,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,INDUSTRY,,,,,,,2022,0.0
NCT03235752,,2017-07-28,,,2021-01-03,2017-07-28,2017-08-01,ACTUAL,,,,,,,2021-01-03,2021-01-05,ACTUAL,2018-02-06,ACTUAL,2018-02-06,2020-12,2020-12-31,2020-12-21,ACTUAL,2020-12-21,2020-12-21,ACTUAL,2020-12-21,,INTERVENTIONAL,,,Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis,"A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients With Active Ulcerative Colitis",COMPLETED,,PHASE2,91.0,ACTUAL,I-Mab Biopharma HongKong Limited,,3.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,INDUSTRY,,,,,,,2020,1.0
NCT02957032,,2016-10-17,,,2023-10-06,2016-11-03,2016-11-06,ESTIMATED,,,,,,,2023-10-06,2023-10-10,ACTUAL,2016-04-13,ACTUAL,2016-04-13,2023-10,2023-10-31,2023-09-29,ACTUAL,2023-09-29,2023-09-29,ACTUAL,2023-09-29,,INTERVENTIONAL,,,A Study of the Tumor-targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Very Low-dose Cytarabine in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation,A Dose-finding Phase I Study of the Tumor-targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Very Low-dose Cytarabine in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation,TERMINATED,,PHASE1,30.0,ESTIMATED,Philogen S.p.A.,,1.0,,New agents for the same indication impacted on patients' recruitment,f,,,,,,,,,,,,,,,,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,INDUSTRY,,,,,,,2023,0.0
NCT03294694,,2017-09-19,,,2022-03-16,2017-09-25,2017-09-27,ACTUAL,,,,,,,2022-03-16,2022-03-31,ACTUAL,2017-11-08,ACTUAL,2017-11-08,2022-03,2022-03-31,2020-10-14,ACTUAL,2020-10-14,2020-10-14,ACTUAL,2020-10-14,,INTERVENTIONAL,,,Ribociclib + PDR001 in Breast Cancer and Ovarian Cancer,A Phase 1 Study of the CDK4/6 Inhibitor Ribociclib (LEE011) in Combination With the PD-1 Inhibitor PDR001 in Patients With Metastatic Hormone Receptor-positive Breast Cancer and Metastatic Ovarian Cancer,TERMINATED,,PHASE1,33.0,ACTUAL,Dana-Farber Cancer Institute,,2.0,,Safety Implications,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,OTHER,,,,,,,2020,0.0
NCT01845441,,2013-04-29,2022-10-12,,2022-11-29,2013-05-01,2013-05-03,ESTIMATED,2022-11-29,2022-12-28,ACTUAL,,,,2022-11-29,2022-12-28,ACTUAL,2012-04,,2012-04-30,2022-11,2022-11-30,2021-12,ACTUAL,2021-12-31,2021-12,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Use of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions,"A Randomized, Controlled Trial on Dexmedetomidine for Providing Adequate Sedation and Preserved Neurologic Examination for Endovascular Treatment of Acute Ischemic Stroke or Cerebral Vasospasm.",TERMINATED,,PHASE2,7.0,ACTUAL,University Hospitals Cleveland Medical Center,,2.0,,The principal investigator left employment at the sponsoring Institution,f,,,,t,,,,,,,,,,,,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,OTHER,,,,,,,2021,0.0
NCT04205643,,2019-12-18,2023-07-06,,2023-09-26,2019-12-18,2019-12-19,ACTUAL,2023-09-26,2023-09-28,ACTUAL,,,,2023-09-26,2023-09-28,ACTUAL,2020-09-01,ACTUAL,2020-09-01,2023-08,2023-08-31,2023-07-11,ACTUAL,2023-07-11,2022-07-07,ACTUAL,2022-07-07,,INTERVENTIONAL,,All-randomized population,CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC),"A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis",COMPLETED,,PHASE3,548.0,ACTUAL,Celltrion,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2023,1.0
NCT04933227,,2021-06-17,,,2024-03-07,2021-06-17,2021-06-21,ACTUAL,,,,,,,2024-03-07,2024-03-12,ACTUAL,2021-08-06,ACTUAL,2021-08-06,2024-03,2024-03-31,2023-11-17,ACTUAL,2023-11-17,2023-11-17,ACTUAL,2023-11-17,,INTERVENTIONAL,,,"A Study to Explore the Efficacy and Safety of Atezolizumab Plus Tiragolumab and Chemotherapy in 1st Line HER2 Negative Unresectable, Recurrent or Metastatic Gastric Cancer or Adenocarcinoma of Gastroesophageal Junction (GEJ)","A Phase II, Single-Arm Study to Explore the Efficacy and Safety of Atezolizumab Plus Tiragolumab and Chemotherapy in 1st Line HER2 Negative Unresectable, Recurrent or Metastatic Gastric Cancer or Adenocarcinoma of Gastroesophageal Junction (GEJ)",TERMINATED,,PHASE2,29.0,ACTUAL,Hoffmann-La Roche,,1.0,,Sponsor's decision to terminate the study after Stage 1; will not proceed with Stage 2.,f,,,,,t,f,,,t,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2023,0.0
NCT02944864,,2016-10-24,,,2024-09-19,2016-10-24,2016-10-26,ESTIMATED,,,,,,,2024-09-19,2024-09-23,ACTUAL,2017-09-13,ACTUAL,2017-09-13,2016-12,2016-12-31,2022-09-15,ACTUAL,2022-09-15,2021-05-23,ACTUAL,2021-05-23,,INTERVENTIONAL,,,A Phase I Study of TQ-B3395 on Tolerance and Pharmacokinetics,Phase I Study of Tolerance and Pharmacokinetics of TQ-B3395 in Patients With Advanced Cancer,TERMINATED,,PHASE1,53.0,ACTUAL,"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",,1.0,,Per sponsor request.,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,INDUSTRY,,,,,,,2022,0.0
NCT02981173,,2016-11-11,,,2023-12-08,2016-11-30,2016-12-05,ESTIMATED,,,,,,,2023-12-08,2023-12-15,ACTUAL,2016-12-05,ACTUAL,2016-12-05,2023-12,2023-12-31,2022-10-21,ACTUAL,2022-10-21,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,,Psilocybin for the Treatment of Cluster Headache,Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders,COMPLETED,,PHASE1,25.0,ACTUAL,Yale University,,3.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 10:10:04.261258,2024-10-16 10:10:04.261258,OTHER,,,,,,,2022,1.0
NCT03752190,,2018-11-21,,,2019-05-08,2018-11-21,2018-11-23,ACTUAL,,,,,,,2019-05-08,2019-05-10,ACTUAL,2019-07,ESTIMATED,2019-07-31,2019-05,2019-05-31,2020-12-31,ESTIMATED,2020-12-31,2020-09-30,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,Comparison of Intramuscular and Intravenous ACTH Stimulation Test in Normal Volunteers,Comparison of Intramuscular and Intravenous ACTH Stimulation Test in Normal Volunteers,WITHDRAWN,,PHASE4,0.0,ACTUAL,Johns Hopkins University,,1.0,,Change in personnel leading to inability to conduct study.,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,OTHER,,,,,,,2020,0.0
NCT05210517,,2022-01-13,,,2023-04-28,2022-01-13,2022-01-27,ACTUAL,,,,,,,2023-04-28,2023-05-01,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2023-04,2023-04-30,2021-09-01,ACTUAL,2021-09-01,2021-06-08,ACTUAL,2021-06-08,,INTERVENTIONAL,UREX,,SGLT2 Inhibition: Uric Acid Excretion Study,Uric Acid Excretion Study: Open-label Randomised Cross Over Study,COMPLETED,,PHASE4,10.0,ACTUAL,"Amsterdam UMC, location VUmc",,4.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,OTHER,,,,,,,2021,1.0
NCT05184101,,2022-01-06,,,2024-02-22,2022-01-06,2022-01-11,ACTUAL,,,,,,,2024-02-22,2024-02-26,ACTUAL,2023-08,ESTIMATED,2023-08-31,2024-02,2024-02-29,2024-03-01,ESTIMATED,2024-03-01,2023-12-01,ESTIMATED,2023-12-01,,INTERVENTIONAL,INHALE-HEP,,Inhaled Heparin for Hospitalised Patients With Coronavirus Disease 2019 (COVID-19),INHALEd Nebulised Unfractionated HEParin for the Treatment of Hospitalised Patients With COVID-19 (INHALE-HEP) Australia,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Australian National University,,2.0,,"COVID-19 hospitalisations limited in Australia, unable to recruit patients due to low numbers of hospitalisations.",f,,,,t,f,f,,,,,,real-time,,,YES,Planned international meta-trial see NCT04635241,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,OTHER,,,,,,,2024,0.0
NCT04427540,,2020-06-05,,,2021-04-07,2020-06-08,2020-06-11,ACTUAL,,,,,,,2021-04-07,2021-04-12,ACTUAL,2021-12,ESTIMATED,2021-12-31,2021-04,2021-04-30,2022-12,ESTIMATED,2022-12-31,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,Oxytocin Pharmacokinetics After Intramuscular Injection,Oxytocin Pharmacokinetics After Intramuscular Injection,WITHDRAWN,,PHASE2,0.0,ACTUAL,Wake Forest University Health Sciences,,1.0,,Study was not initiated; no subjects were consented or enrolled,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,OTHER,,,,,,,2022,0.0
NCT04911790,,2021-06-02,,,2023-09-21,2021-06-02,2021-06-03,ACTUAL,,,,,,,2023-09-21,2023-09-25,ACTUAL,2021-06-05,ACTUAL,2021-06-05,2021-05,2021-05-31,2023-08-31,ACTUAL,2023-08-31,2023-01-02,ACTUAL,2023-01-02,,INTERVENTIONAL,,,Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Adults,"Safety Observation of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Population Aged 18 Years and Older: A Multicenter,Open-label Study",COMPLETED,,PHASE4,131650.0,ACTUAL,"Sinovac Biotech Co., Ltd",,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,INDUSTRY,,,,,,,2023,1.0
NCT00669669,,2008-04-29,2018-11-07,,2022-04-29,2008-04-29,2008-04-30,ESTIMATED,2018-12-06,2018-12-28,ACTUAL,,,,2022-04-29,2022-05-18,ACTUAL,2009-02-25,ACTUAL,2009-02-25,2022-01,2022-01-31,2021-01-20,ACTUAL,2021-01-20,2018-07-06,ACTUAL,2018-07-06,,INTERVENTIONAL,,,O6-Benzylguanine-Mediated Tumor Sensitization With Chemoprotected Autologous Stem Cell in Treating Patients With Malignant Gliomas,Benzylguanine-Mediated Tumor Sensitization With Chemoprotected Autologous Stem Cells for Patients With Malignant Gliomas,TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,Terminated due to loss in funding.,f,,,,t,,,,,,,,,,,,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,OTHER,,,,,,,2021,0.0
NCT05820152,,2023-04-06,,,2024-09-18,2023-04-06,2023-04-19,ACTUAL,,,,,,,2024-09-18,2024-09-20,ACTUAL,2023-08-15,ACTUAL,2023-08-15,2024-09,2024-09-30,2024-06-24,ACTUAL,2024-06-24,2024-06-24,ACTUAL,2024-06-24,,INTERVENTIONAL,,,Gene Therapy Clinical Trial for the Treatment of Leber's Hereditary Optic Neuropathy Associated With ND1 Mutations,"A Phase 1/2, Multi-regional, Single-Arm, Open-Label, Dose-Finding Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Gene Therapy for Leber's Hereditary Optic Neuropathy (LHON) Associated With ND1 Mutation",TERMINATED,,PHASE1/PHASE2,11.0,ACTUAL,Neurophth Therapeutics Inc,,1.0,,Due to the sponsor circumstances and external reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:53:37.032679,2024-10-14 23:53:37.032679,OTHER,,,,,,,2024,0.0
NCT05304130,,2022-03-22,,,2023-01-24,2022-03-22,2022-03-31,ACTUAL,,,,,,,2023-01-24,2023-01-26,ACTUAL,2023-02-08,ESTIMATED,2023-02-08,2023-01,2023-01-31,2023-05-04,ESTIMATED,2023-05-04,2023-05-04,ESTIMATED,2023-05-04,,INTERVENTIONAL,,,A Study in Healthy Japanese Participants to Evaluate the Safety and Pharmacokinetics of Otilimab,"A Single Center, Single Dose, Open-label Study in Healthy Japanese Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Otilimab",WITHDRAWN,,PHASE1,0.0,ACTUAL,GlaxoSmithKline,,1.0,,This study was cancelled because of the limited efficacy demonstrated in the ContRAst phase III programme as a potential treatment for rheumatoid arthritis. GSK has decided not to progress with regulatory submissions,f,,,,f,f,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2023,0.0
NCT05467761,,2022-07-18,,,2023-05-11,2022-07-18,2022-07-20,ACTUAL,,,,,,,2023-05-11,2023-05-15,ACTUAL,2023-06,ESTIMATED,2023-06-30,2023-05,2023-05-31,2024-03,ESTIMATED,2024-03-31,2024-03,ESTIMATED,2024-03-31,,INTERVENTIONAL,,,Bioavailability Study of Psilocybin in Normal Adults,A Phase 1 Study Comparing the Pharmacokinetics and Safety of Intravenous and Oral Psilocybin,WITHDRAWN,,PHASE1,0.0,ACTUAL,"University of Wisconsin, Madison",,1.0,,Sponsor was not financially able or willing to continue to support the study,f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,OTHER,,,,,,,2024,0.0
NCT05257148,,2022-02-16,2022-12-23,,2024-05-21,2022-02-16,2022-02-25,ACTUAL,2024-05-21,2024-09-20,ACTUAL,,,,2024-05-21,2024-09-20,ACTUAL,2021-05-26,ACTUAL,2021-05-26,2023-11,2023-11-30,2021-12-22,ACTUAL,2021-12-22,2021-12-22,ACTUAL,2021-12-22,,INTERVENTIONAL,Masaccio,Intentio to treat population,Effectiveness and Safety of Combination of Nebivolol and Zofenopril in Hypertensive patIents Versus Each Monotherapy,"Open-label, Multicenter, Multinational, Interventional Clinical Trial to Assess Effectiveness and SAfety of the Extemporaneous Combination of Nebivolol and Zofenopril Calcium in Grade 1 to 2 Hypertensive patIents Versus Each mOnotherapy",COMPLETED,,PHASE4,283.0,ACTUAL,Menarini International Operations Luxembourg SA,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,INDUSTRY,,,,,,,2021,1.0
NCT05321498,,2022-03-03,,,2023-09-26,2022-04-04,2022-04-11,ACTUAL,,,,,,,2023-09-26,2023-09-28,ACTUAL,2023-06,ESTIMATED,2023-06-30,2023-09,2023-09-30,2023-10-26,ESTIMATED,2023-10-26,2023-10-26,ESTIMATED,2023-10-26,,INTERVENTIONAL,,,Study to Assess the Efficacy of XPro1595 in Patients With Mild Cognitive Impairment With Biomarkers of Inflammation,"A Phase 2, Randomized, Placebo-Controlled, Double-Blind Study of XPro1595 in Patients With Mild Cognitive Impairment (MCI) With Biomarkers of Inflammation",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Inmune Bio, Inc.",,2.0,,MCI patients will now be enrolled in the XPro1595-AD-02 study.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,INDUSTRY,,,,,,,2023,0.0
NCT03763422,,2018-11-13,,,2022-01-31,2018-12-02,2018-12-04,ACTUAL,,,,,,,2022-01-31,2022-02-01,ACTUAL,2020-03-16,ACTUAL,2020-03-16,2022-01,2022-01-31,2021-12-29,ACTUAL,2021-12-29,2021-12-29,ACTUAL,2021-12-29,,INTERVENTIONAL,IWOT,,Trial in Low Grade Glioma Patients: Wait or Treat,IDH Mutated 1p/19q Intact Lower Grade Glioma Following Resection: Wait Or Treat? IWOT - a Phase III Study,TERMINATED,,PHASE3,19.0,ACTUAL,European Organisation for Research and Treatment of Cancer - EORTC,,2.0,,Poorly recruiting,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,NETWORK,,,,,,,2021,0.0
NCT03497598,,2018-04-05,,,2020-09-01,2018-04-12,2018-04-13,ACTUAL,,,,,,,2020-09-01,2020-09-02,ACTUAL,2018-05-09,ACTUAL,2018-05-09,2020-09,2020-09-30,2020-05-31,ACTUAL,2020-05-31,2020-05-31,ACTUAL,2020-05-31,,INTERVENTIONAL,PUTIM,,Preventing Recurrent Urinary Tract Infections With α-D-mannose,"Preventing Recurrent Urinary Tract Infections With α-D-mannose: a Prospective, Randomized, Double-blinded Placebo-controlled Trial",TERMINATED,,PHASE4,15.0,ACTUAL,Kantonsspital Aarau,,2.0,,not enough patients,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,OTHER,,,,,,,2020,0.0
NCT04052204,,2019-08-02,2021-08-02,,2021-09-17,2019-08-07,2019-08-09,ACTUAL,2021-09-17,2021-10-14,ACTUAL,,,,2021-09-17,2021-10-14,ACTUAL,2019-12-30,ACTUAL,2019-12-30,2021-09,2021-09-30,2020-09-29,ACTUAL,2020-09-29,2020-09-29,ACTUAL,2020-09-29,,INTERVENTIONAL,,,Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors,A Phase 1b/2 Study to Evaluate Safety and Clinical Activity of Avelumab in Combination With Bempegaldesleukin(NKTR-214) With or Without Talazoparib or Enzalutamide in Participants With Locally Advanced or Metastatic Solid Tumors,TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,Pfizer,"Phase 1b part of Combination A was conducted but not completed as company terminated this study on 21 May 2021. Termination was not due to a regulatory request or new emerging safety signals. Test for Combination B, Combination C and Phase 2 expansion for Combination A planned in the protocol were not conducted.",3.0,,Study prematurely terminated as the experimental treatments evaluated in study B9991040 may not provide additional clinical benefit over current or future Standard of Care in the different therapeutic indications that this trial was to evaluate.,f,,,,f,t,f,,,t,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,INDUSTRY,,,,,,,2020,0.0
NCT04585932,,2020-05-19,,,2021-01-14,2020-10-06,2020-10-14,ACTUAL,,,,,,,2021-01-14,2021-01-20,ACTUAL,2020-11-24,ACTUAL,2020-11-24,2021-01,2021-01-31,2021-01-08,ACTUAL,2021-01-08,2021-01-08,ACTUAL,2021-01-08,,INTERVENTIONAL,,,"Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study",Phase 2 Response Evaluation of Finite Systemic Therapy With Advanced Androgen Signaling Inhibition and Radiation Therapy for Oligorecurrent Prostate Cancer (RESTART),WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,At the request of the ad interim Department Chairman due to PI is no longer at institution.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,OTHER,,,,,,,2021,0.0
NCT04517864,,2020-08-14,2022-10-17,,2024-05-22,2020-08-14,2020-08-18,ACTUAL,2022-12-05,2022-12-28,ACTUAL,,,,2024-05-22,2024-06-18,ACTUAL,2020-09-15,ACTUAL,2020-09-15,2024-05,2024-05-31,2024-05-07,ACTUAL,2024-05-07,2022-01-04,ACTUAL,2022-01-04,,INTERVENTIONAL,Allegro2a,Baseline analysis population included all participants taking at least 1 dose of study intervention.,PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA,"A PHASE 2a, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY INVESTIGATING THE SAFETY OF RITLECITINIB (PF-06651600) IN ADULT PARTICIPANTS WITH ALOPECIA AREATA",TERMINATED,,PHASE2,71.0,ACTUAL,Pfizer,,2.0,,For business reasons,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,INDUSTRY,,,,,,,2024,0.0
NCT03367195,,2017-11-27,,,2021-01-06,2017-12-07,2017-12-08,ACTUAL,,,,,,,2021-01-06,2021-01-07,ACTUAL,2018-08-16,ACTUAL,2018-08-16,2021-01,2021-01-31,2020-09-09,ACTUAL,2020-09-09,2020-05-04,ACTUAL,2020-05-04,,INTERVENTIONAL,,,Efficacy and Safety of DLBS2411 in the Management of GERD,Efficacy and Safety of DLBS2411 Compared to Omeprazole in the Management of Gastroesophageal Reflux Disease (GERD),TERMINATED,,PHASE3,32.0,ACTUAL,Dexa Medica Group,,2.0,,"Very low recruitment rate. The Study Site classifies as tertiary referral hospital. Therefore, GERD Patients being referred to the site are mostly those with comorbidities included in the exclusion criteria.",f,,,,f,f,f,,,,,,,,,,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2020,0.0
NCT05220293,,2022-01-21,,,2024-04-30,2022-01-21,2022-02-02,ACTUAL,,,,,,,2024-04-30,2024-05-02,ACTUAL,2022-02-23,ACTUAL,2022-02-23,2024-04,2024-04-30,2023-12-30,ACTUAL,2023-12-30,2023-12-30,ACTUAL,2023-12-30,,INTERVENTIONAL,OT-007,,Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream,The Effect of Betamethasone Dipropionate on Patients With Eosinophilic Chronic Rhinosinusitis,TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,Oticara Australia PTY LTD,,1.0,,Single site study OT-007 re-opened as multi-site OT-007B study,f,,,,f,t,t,t,,t,,,,,,NO,There is not a plan to make IPD available.,2024-10-16 10:10:04.261258,2024-10-16 10:10:04.261258,INDUSTRY,,,,,,,2023,0.0
NCT03291288,,2017-09-19,2020-02-12,,2021-04-19,2017-09-20,2017-09-25,ACTUAL,2020-03-05,2020-03-19,ACTUAL,,,,2021-04-19,2021-05-14,ACTUAL,2018-02-26,ACTUAL,2018-02-26,2021-04,2021-04-30,2021-04-16,ACTUAL,2021-04-16,2018-09-26,ACTUAL,2018-09-26,,INTERVENTIONAL,,,Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics),"An Open-label, Single Sequence, Crossover Drug-drug Interaction Study Assessing the Effect of Pexidartinib on the Pharmacokinetics of CYP3A4 and CYP2C9 Substrates in Patients",COMPLETED,,PHASE1,32.0,ACTUAL,Daiichi Sankyo,,1.0,,,f,,,,f,t,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,INDUSTRY,,,,,,,2021,1.0
NCT05395260,,2022-05-19,,,2022-08-17,2022-05-24,2022-05-27,ACTUAL,,,,,,,2022-08-17,2022-08-19,ACTUAL,2022-08-22,ESTIMATED,2022-08-22,2022-08,2022-08-31,2022-12-28,ESTIMATED,2022-12-28,2022-11-28,ESTIMATED,2022-11-28,,INTERVENTIONAL,,,FL- 101 Study in Non-Metastatic MIBC,A Pilot Window of Opportunity Trial: FL-101 in Non-Metastatic Muscle Invasive Bladder Cancer,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Flame Biosciences,,1.0,,Sponsor Decision,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2022,0.0
NCT04868708,,2021-04-05,,,2024-04-23,2021-04-30,2021-05-03,ACTUAL,,,,,,,2024-04-23,2024-04-25,ACTUAL,2021-04-01,ACTUAL,2021-04-01,2024-04,2024-04-30,2024-02-28,ACTUAL,2024-02-28,2024-02-28,ACTUAL,2024-02-28,,INTERVENTIONAL,,,A Study of AK104（ an Anti-PD-1 and Anti-CTLA-4 Bispecific Antibody) in Recurrent or Metastatic Cervical Cancer,"A Multicenter, Open-label, Phase II Study of AK104（an Anti-PD-1 and Anti-CTLA-4 Bispecific Antibody) in the Treatment of Recurrent or Metastatic Cervical Cancer",COMPLETED,,PHASE2,50.0,ACTUAL,Akeso,,3.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2024,1.0
NCT04037462,,2019-07-26,2023-07-27,,2024-05-20,2019-07-26,2019-07-30,ACTUAL,2024-05-20,2024-06-14,ACTUAL,,,,2024-05-20,2024-06-14,ACTUAL,2021-07-07,ACTUAL,2021-07-07,2024-05,2024-05-31,2023-02-23,ACTUAL,2023-02-23,2022-02-23,ACTUAL,2022-02-23,,INTERVENTIONAL,,,Induction of Sensecence Using Dexamethasone to Re-sensitize NSCLC to Anti-PD1 Therapy,Induction of Sensecence Using Dexamethasone to Re-sensitize NSCLC to Anti-PD1 Therapy,TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,VA Office of Research and Development,"We consented 3 participants and had one subject rescind consent leaving us with 2 enrolled participants. of the 2 participants only was was evaluable. Therefore, we do not have sufficient data to prove outcomes measures",1.0,,Low accrual,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 10:10:04.261258,2024-10-16 10:10:04.261258,FED,,,,,,,2023,0.0
NCT05393037,,2022-05-23,2024-06-27,,2024-06-27,2022-05-23,2022-05-26,ACTUAL,2024-06-27,2024-07-25,ACTUAL,,,,2024-06-27,2024-07-25,ACTUAL,2022-07-13,ACTUAL,2022-07-13,2024-06,2024-06-30,2024-01-25,ACTUAL,2024-01-25,2023-07-13,ACTUAL,2023-07-13,,INTERVENTIONAL,,,"Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)","A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults Living With HIV",COMPLETED,,PHASE3,313.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2024,1.0
NCT04887064,,2021-05-11,2023-01-23,,2023-11-07,2021-05-11,2021-05-14,ACTUAL,2023-11-07,2024-04-19,ACTUAL,,,,2023-11-07,2024-04-19,ACTUAL,2021-04-22,ACTUAL,2021-04-22,2023-01,2023-01-31,2022-03-09,ACTUAL,2022-03-09,2022-03-09,ACTUAL,2022-03-09,,INTERVENTIONAL,,Safety Population: All participants who received sotorasib and had at least 1 postdose safety assessment.,Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment,An Open-label Single-dose Study to Evaluate the Pharmacokinetics of Sotorasib in Healthy Subjects and Subjects With Moderate or Severe Hepatic Impairment,COMPLETED,,PHASE1,20.0,ACTUAL,Amgen,,3.0,,,t,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,INDUSTRY,,NCT04667234,NO_LONGER_AVAILABLE,,,,2022,1.0
NCT03814148,,2019-01-22,,,2021-02-22,2019-01-22,2019-01-23,ACTUAL,,,,,,,2021-02-22,2021-02-24,ACTUAL,2019-06,ESTIMATED,2019-06-30,2021-02,2021-02-28,2020-09,ESTIMATED,2020-09-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension,"Randomized, Double-blind, Double-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension",WITHDRAWN,,PHASE3,0.0,ACTUAL,EMS,,2.0,,The design of this protocol was rewritten due to regulatory recommendations.,f,,,,t,f,f,,,,,,,,,,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,INDUSTRY,,,,,,,2020,0.0
NCT03262142,,2017-08-21,,,2023-05-24,2017-08-23,2017-08-25,ACTUAL,,,,,,,2023-05-24,2023-05-25,ACTUAL,2018-01-10,ACTUAL,2018-01-10,2023-05,2023-05-31,2023-03-01,ACTUAL,2023-03-01,2023-03-01,ACTUAL,2023-03-01,,INTERVENTIONAL,Target-ABC,,Targeted AntiBiotics for Chronic Pulmonary Diseases,"Targeted AntiBiotics for Chronic Pulmonary Disease: Can Targeted Antibiotic Therapy Improve the Prognosis of Pseudomonas Aeruginosa Infected Patients With Chronic Pulmonary Obstructive Disease, Non-cystic Fibrosis Bronchiectasis and Asthma? A Multicenter, Randomized, Controlled, Open-label Trial.",TERMINATED,,PHASE4,51.0,ACTUAL,"Chronic Obstructive Pulmonary Disease Trial Network, Denmark",,2.0,,Slow recruitment,f,,,,t,f,f,,,,,,,,,YES,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,OTHER,,,,,,,2023,0.0
NCT04607668,,2020-10-20,,,2023-04-05,2020-10-23,2020-10-29,ACTUAL,,,,,,,2023-04-05,2023-04-07,ACTUAL,2020-10-16,ACTUAL,2020-10-16,2023-04,2023-04-30,2023-03-31,ACTUAL,2023-03-31,2023-02-13,ACTUAL,2023-02-13,,INTERVENTIONAL,PRESERVE1,,"Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):","PRESERVE 1: A Phase 3 Randomized, Double-blind Trial of Trilaciclib Versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer",TERMINATED,,PHASE3,326.0,ACTUAL,"G1 Therapeutics, Inc.",,2.0,,"Despite achieving co-primary endpoints \& other secondary measures of myeloprotection \& tolerability, early anti-tumor efficacy data favor patients receiving placebo. Given the low likelihood of achieving PFS \& OS endpoints, G1 decided to discontinue",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,INDUSTRY,,,,,,,2023,0.0
NCT04480190,,2020-06-25,,,2022-04-12,2020-07-16,2020-07-21,ACTUAL,,,,,,,2022-04-12,2022-04-20,ACTUAL,2021-02-04,ACTUAL,2021-02-04,2022-04,2022-04-30,2022-04-04,ACTUAL,2022-04-04,2022-04-04,ACTUAL,2022-04-04,,INTERVENTIONAL,,,Neoadjuvant Therapy in Biliary Adenocarcinoma,Feasibility of Total Neoadjuvant Therapy in Resectable Biliary Adenocarcinoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Cincinnati,,1.0,,Difficulty accruing,f,,,,t,t,t,,,,,,,,,NO,,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,OTHER,,,,,,,2022,0.0
NCT03901352,,2019-04-01,2022-11-22,,2024-05-01,2019-04-01,2019-04-03,ACTUAL,2024-05-01,2024-09-23,ACTUAL,,,,2024-05-01,2024-09-23,ACTUAL,2019-03-12,ACTUAL,2019-03-12,2024-05,2024-05-31,2020-12-28,ACTUAL,2020-12-28,2020-12-28,ACTUAL,2020-12-28,,INTERVENTIONAL,,"Data were based on the modified Intent-to-Treat population (mITT). Mirogabalin starting dose and titration schedule were based on creatinine clearance per the Japanese drug insert. All mirogabalin patients who received any dose were assessed as 1 group for efficacy/safety as prespecified in the protocol. The sponsor considers it undesirable to conduct a separate analysis per dose level, as it would involve publishing completely separate analyses than the insert and report previously submitted.",Study of Mirogabalin for Central Neuropathic Pain,"An Asian, Multicenter, Randomized, Double-blind, Placebo-controlled, 14-week Study of Mirogabalin in Participants With Central Neuropathic Pain Followed by a 52-week, Open-label Extension",COMPLETED,,PHASE3,300.0,ACTUAL,Daiichi Sankyo,,2.0,,,f,,,,f,f,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",http://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,INDUSTRY,,,,,,,2020,1.0
NCT02384759,,2015-01-28,2022-12-21,,2024-07-05,2015-03-04,2015-03-10,ESTIMATED,2024-07-05,2024-07-10,ACTUAL,,,,2024-07-05,2024-07-10,ACTUAL,2015-05,ACTUAL,2015-05-31,2024-07,2024-07-31,2021-06,ACTUAL,2021-06-30,2021-06,ACTUAL,2021-06-30,,INTERVENTIONAL,FOLFA,Baseline population is the mITT population meaning all the patients randomized into the study and having received at least one dose of study treatment,Aflibercept +/- LV5FU2 in First Line of Non-resectalbe Metastatic Colorectal Cancers,Phase II Randomized Trial Evaluting Aflibercept Associated With LV5FU2 Regimen as First Line Treatment of Non-resectalbe Metastatic Colorectal Cancers,COMPLETED,,PHASE2,117.0,ACTUAL,Federation Francophone de Cancerologie Digestive,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,OTHER,,,,,,,2021,1.0
NCT02656303,,2016-01-13,2023-05-26,,2023-05-26,2016-01-13,2016-01-14,ESTIMATED,2023-05-26,2023-06-22,ACTUAL,,,,2023-05-26,2023-06-22,ACTUAL,2016-01-07,ACTUAL,2016-01-07,2023-05,2023-05-31,2022-07-11,ACTUAL,2022-07-11,2022-05-26,ACTUAL,2022-05-26,,INTERVENTIONAL,,The Safety Population included all participants who were enrolled and received at least one dose of study drug.,A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304,"A Multi-Center, Open-Label, Compassionate Use Extension Study of Ublituximab (TG-1101) in Combination With Umbralisib (TGR-1202) for Patients Previously Enrolled in Protocol UTX-TGR-304",TERMINATED,,PHASE2,116.0,ACTUAL,"TG Therapeutics, Inc.","Due to sponsor's business decision, the clinical trial was terminated by the sponsor.",3.0,,Strategic/Business Decision,f,,,,f,t,f,,,,,,,,,,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2022,0.0
NCT04152837,,2019-10-31,2023-02-07,,2023-03-14,2019-11-04,2019-11-05,ACTUAL,2023-03-14,2023-04-10,ACTUAL,,,,2023-03-14,2023-04-10,ACTUAL,2020-09-02,ACTUAL,2020-09-02,2023-03,2023-03-31,2022-07-29,ACTUAL,2022-07-29,2022-07-29,ACTUAL,2022-07-29,,INTERVENTIONAL,ALERT,,Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease,An Open-Label Study of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Previously Experienced Abnormal Liver Chemistry Test Results While Receiving Tolvaptan: The ALERT Study,TERMINATED,,PHASE3,7.0,ACTUAL,Palladio Biosciences,Efficacy and safety results are limited by the early termination of the trial and the small number of subjects. Early termination was due to a sponsor decision for reasons unrelated to safety.,1.0,,The decision is based on a thorough reassessment of the commercial potential of lixivaptan as a potential best-in-class therapy for patients with ADPKD,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2022,0.0
NCT03759392,,2018-11-15,2023-01-06,,2023-02-11,2018-11-28,2018-11-30,ACTUAL,2023-02-11,2023-03-07,ACTUAL,,,,2023-02-11,2023-03-07,ACTUAL,2019-04-09,ACTUAL,2019-04-09,2023-02,2023-02-28,2022-01-06,ACTUAL,2022-01-06,2021-11-08,ACTUAL,2021-11-08,,INTERVENTIONAL,METEORIC-HF,,Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure,"A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure With Reduced Ejection Fraction and Decreased Exercise Tolerance",COMPLETED,,PHASE3,276.0,ACTUAL,Cytokinetics,,2.0,,,f,,,,t,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2022,1.0
NCT05215977,,2022-01-18,,,2023-10-08,2022-01-18,2022-01-31,ACTUAL,,,,,,,2023-10-08,2023-10-11,ACTUAL,2019-12-27,ACTUAL,2019-12-27,2023-10,2023-10-31,2021-09-27,ACTUAL,2021-09-27,2021-09-27,ACTUAL,2021-09-27,,INTERVENTIONAL,,,Efficacy and Safety of MW031 in PMO Subjects,"A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study, Evaluating the Efficacy and Safety of Recombinant Fully Human Anti-RANKL Monoclonal Antibody in Postmenopausal Osteoporosis Subjects With Increased Bone Fracture Risk",COMPLETED,,PHASE3,448.0,ACTUAL,"Mabwell (Shanghai) Bioscience Co., Ltd.",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2021,1.0
NCT04149821,,2019-10-30,2023-04-20,,2023-05-23,2019-10-30,2019-11-04,ACTUAL,2023-05-23,2023-06-15,ACTUAL,,,,2023-05-23,2023-06-15,ACTUAL,2021-02-10,ACTUAL,2021-02-10,2023-05,2023-05-31,2022-06-09,ACTUAL,2022-06-09,2022-01-21,ACTUAL,2022-01-21,,INTERVENTIONAL,,0 subjects were enrolled in Cohort A.,Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy,Phase II Study of Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy,TERMINATED,,PHASE2,1.0,ACTUAL,Weill Medical College of Cornell University,The study did not reach the target number of participants needed to achieve target power and statistically reliable results,2.0,,Terminated due to low accrual,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,OTHER,,,,,,,2022,0.0
NCT05473442,,2022-07-18,,,2023-12-15,2022-07-21,2022-07-26,ACTUAL,,,,,,,2023-12-15,2023-12-21,ACTUAL,2022-12-27,ACTUAL,2022-12-27,2023-12,2023-12-31,2023-07-01,ACTUAL,2023-07-01,2023-07-01,ACTUAL,2023-07-01,,INTERVENTIONAL,,,Study of EQU-001 for Uncontrolled Focal Onset Seizures,A Randomized Phase 2 Study of Adjunctive EQU-001 for Uncontrolled Focal Onset Seizures,TERMINATED,,PHASE2,27.0,ACTUAL,Equilibre Biopharmaceuticals B.V.,,3.0,,insufficient funding to complete the study,f,,,,f,t,f,,,,,,,,,,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,INDUSTRY,,,,,,,2023,0.0
NCT04090229,,2019-09-11,,,2022-01-11,2019-09-13,2019-09-16,ACTUAL,,,,,,,2022-01-11,2022-01-12,ACTUAL,2019-09-09,ACTUAL,2019-09-09,2022-01,2022-01-31,2021-12-03,ACTUAL,2021-12-03,2021-10-28,ACTUAL,2021-10-28,,INTERVENTIONAL,,,"A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis","A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis",COMPLETED,,PHASE1,52.0,ACTUAL,ASLAN Pharmaceuticals,,2.0,,,,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,OTHER,,,,,,,2021,1.0
NCT03237572,,2017-07-31,,,2022-09-07,2017-07-31,2017-08-02,ACTUAL,,,,,,,2022-09-07,2022-09-13,ACTUAL,2017-09-25,ACTUAL,2017-09-25,2022-09,2022-09-30,2022-06-17,ACTUAL,2022-06-17,2022-06-01,ACTUAL,2022-06-01,,INTERVENTIONAL,Breast-48,,Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer,Focused Ultrasound Therapy to Augment Antigen Presentation and Immune-Specificity of Checkpoint Inhibitor Therapy With Pembrolizumab in Metastatic Breast Cancer,TERMINATED,,PHASE1,13.0,ACTUAL,University of Virginia,,2.0,,Low rate of enrollment,f,,,,t,t,t,t,,,,,,,,,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,OTHER,,,,,,,2022,0.0
NCT05232864,,2022-01-31,2024-08-06,,2024-08-06,2022-01-31,2022-02-10,ACTUAL,2024-08-06,2024-08-30,ACTUAL,,,,2024-08-06,2024-08-30,ACTUAL,2022-08-22,ACTUAL,2022-08-22,2024-07,2024-07-31,2023-08-23,ACTUAL,2023-08-23,2023-08-23,ACTUAL,2023-08-23,,INTERVENTIONAL,,,"Open-label Extension Study of Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Lupus Nephritis","A Three-year, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Efficacy, Safety and Tolerability in Patients With Active Lupus Nephritis",TERMINATED,,PHASE3,31.0,ACTUAL,Novartis,,1.0,,Study terminated by sponsor based on a futility analysis of the core study CAIN457Q12301,f,,,,t,t,f,,,,,,,,,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,INDUSTRY,,,,,,,2023,0.0
NCT04811872,,2021-03-11,,,2022-06-13,2021-03-20,2021-03-23,ACTUAL,,,,,,,2022-06-13,2022-06-15,ACTUAL,2021-01-01,ACTUAL,2021-01-01,2022-06,2022-06-30,2021-10-01,ACTUAL,2021-10-01,2021-09-01,ACTUAL,2021-09-01,,INTERVENTIONAL,,,Placental Transfusion Effect on Hemodynamics of Premature Newborns,Evaluation of the Effect of Placental Transfusion on Hemodynamics in Premature Newborns,COMPLETED,,PHASE2/PHASE3,57.0,ACTUAL,Alexandria University,,3.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,OTHER,,,,,,,2021,0.0
NCT04392141,,2020-05-15,2020-11-25,,2021-04-16,2020-05-15,2020-05-18,ACTUAL,2021-04-16,2021-04-20,ACTUAL,,,,2021-04-16,2021-04-20,ACTUAL,2020-04-01,ACTUAL,2020-04-01,2021-04,2021-04-30,2020-11-01,ACTUAL,2020-11-01,2020-11-01,ACTUAL,2020-11-01,,INTERVENTIONAL,,,Colchicine Plus Phenolic Monoterpenes to Treat COVID-19,Application of Colchicine Plus Herbal Phenolic Monoterpene Fractions to Treat COVID-19,COMPLETED,,PHASE1/PHASE2,120.0,ACTUAL,Kermanshah University of Medical Sciences,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,OTHER,,,,,,,2020,1.0
NCT03093831,,2017-03-23,,,2023-10-09,2017-03-23,2017-03-28,ACTUAL,,,,,,,2023-10-09,2023-10-11,ACTUAL,2016-07-08,ACTUAL,2016-07-08,2023-10,2023-10-31,2020-07-17,ACTUAL,2020-07-17,2020-07-17,ACTUAL,2020-07-17,,INTERVENTIONAL,,,Phase II Study of Ibrutinib in Patients With Relapsed or Refractory Marginal Zone Lymphoma,A Phase II Investigator Sponsored Multi-Centre Trial of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Patients With Relapsed or Refractory Marginal Zone Lymphoma,TERMINATED,,PHASE2,5.0,ACTUAL,"National Cancer Centre, Singapore",,1.0,,Study did not meet the objectives and terminated early on 17 Jul 2020 due to poor recruitment,f,,,,f,,,,,,,,,,,NO,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,OTHER,,,,,,,2020,0.0
NCT02440464,,2015-05-07,2021-11-02,,2022-12-12,2015-05-07,2015-05-12,ESTIMATED,2021-12-22,2022-01-21,ACTUAL,,,,2022-12-12,2023-01-04,ACTUAL,2015-08,,2015-08-31,2022-12,2022-12-31,2020-10-01,ACTUAL,2020-10-01,2020-10-01,ACTUAL,2020-10-01,,INTERVENTIONAL,,Participants who were transplanted and randomized are included.,Allogeneic Hematopoietic Stem Cell Transplantation With Ixazomib for High Risk Multiple Myeloma (BMT CTN 1302),"Multicenter Phase II, Double-blind Placebo Controlled Trial of Maintenance Ixazomib After Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Multiple Myeloma (BMT CTN 1302)",COMPLETED,,PHASE2,57.0,ACTUAL,"National Heart, Lung, and Blood Institute (NHLBI)",,2.0,,,f,,,,t,t,f,,,,,,Within 6 months of official study closure at participating sites.,Available to the public,https://biolincc.nhlbi.nih.gov/home/,YES,"Results will be published in a manuscript and supporting information submitted to the NIH Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc where indicated).",2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,NIH,,,,,,,2020,1.0
NCT01307579,,2011-03-01,2019-06-11,,2021-03-26,2011-03-01,2011-03-03,ESTIMATED,2019-08-28,2019-09-17,ACTUAL,,,,2021-03-26,2021-03-30,ACTUAL,2011-04-04,ACTUAL,2011-04-04,2019-06,2019-06-30,2020-06-30,ACTUAL,2020-06-30,2018-06-30,ACTUAL,2018-06-30,,INTERVENTIONAL,,,Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia,A Randomized Open-Label Trial of Caspofungin Versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML),COMPLETED,,PHASE3,517.0,ACTUAL,Children's Oncology Group,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,NETWORK,,,,,,,2020,1.0
NCT04830969,,2021-03-31,2022-07-12,,2023-01-30,2021-03-31,2021-04-05,ACTUAL,2023-01-30,2023-03-01,ACTUAL,,,,2023-01-30,2023-03-01,ACTUAL,2016-11-08,ACTUAL,2016-11-08,2023-01,2023-01-31,2021-01-28,ACTUAL,2021-01-28,2021-01-28,ACTUAL,2021-01-28,,INTERVENTIONAL,DMRCT,"In this study, unit participant is assigned to Arms/Groups in all measures. For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each subject. And the outcome of each participant were analyzed in each Aim.",Impact of Periodontal Therapy on Patients With Diabetes,Impact of Periodontal Therapy on Patients With Diabetes: A Pilot Study,COMPLETED,,PHASE2,116.0,ACTUAL,State University of New York at Buffalo,,4.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,OTHER,,,,,,,2021,1.0
NCT02904772,,2016-05-10,,,2017-08-14,2016-09-13,2016-09-19,ESTIMATED,,,,,,,2017-08-14,2017-08-17,ACTUAL,2016-10,,2016-10-31,2017-07,2017-07-31,2020-09,ESTIMATED,2020-09-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,Alipogene Tiparvovec for the Treatment of LPLD Patients,"An Open Label, Multi-centre Trial of Alipogene Tiparvovec for the Treatment of LPLD Patients",WITHDRAWN,,PHASE2,0.0,ACTUAL,UniQure Biopharma B.V.,,2.0,,"uniQure, has decided not to renew the Marketing Authorization of Glybera in the EU. This decision is not related to any safety, efficacy or quality issue",f,,,,f,,,,,,,,,,,NO,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2020,0.0
NCT02540330,,2015-08-28,2022-02-18,,2024-04-01,2015-09-01,2015-09-03,ESTIMATED,2022-03-15,2022-04-05,ACTUAL,,,,2024-04-01,2024-04-03,ACTUAL,2016-03,ACTUAL,2016-03-31,2024-04,2024-04-30,2020-08-13,ACTUAL,2020-08-13,2020-08-13,ACTUAL,2020-08-13,,INTERVENTIONAL,007,,A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant,"An Open Label, Phase 2 Pharmacokinetic Study of Pre-Surgical Intramuscular and Intraductal Fulvestrant in Women With Invasive Breast Cancer or DCIS Undergoing Mastectomy or Lumpectomy",TERMINATED,,PHASE2,3.0,ACTUAL,"Atossa Therapeutics, Inc.",,2.0,,Business decision (See Detailed Description),f,,,,f,t,f,,,,,,,,,NO,,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,INDUSTRY,,,,,,,2020,0.0
NCT02714218,,2016-03-16,2019-01-02,2018-04-16,2022-06-17,2016-03-18,2016-03-21,ESTIMATED,2019-03-29,2019-04-23,ACTUAL,2018-04-18,2018-04-27,ACTUAL,2022-06-17,2022-06-24,ACTUAL,2016-04-04,ACTUAL,2016-04-04,2022-06,2022-06-30,2021-05-28,ACTUAL,2021-05-28,2017-04-20,ACTUAL,2017-04-20,,INTERVENTIONAL,,,"A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma","Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination With Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination With Ipilimumab 3 mg/kg in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma",COMPLETED,,PHASE3,387.0,ACTUAL,Bristol-Myers Squibb,,3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2021,1.0
NCT02178657,,2014-06-27,,,2024-02-06,2014-06-27,2014-07-01,ESTIMATED,,,,,,,2024-02-06,2024-02-07,ACTUAL,2015-04,,2015-04-30,2024-02,2024-02-29,2023-04-12,ACTUAL,2023-04-12,2021-10-27,ACTUAL,2021-10-27,,INTERVENTIONAL,,,Intra-arterial Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke,"Intra-arterial Autologous Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke. A Phase II, Open-label, Multicenter, Randomized and Controlled Clinical Trial.",COMPLETED,,PHASE2,76.0,ACTUAL,Andalusian Initiative for Advanced Therapies,,3.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,OTHER_GOV,,,,,,,2023,1.0
NCT04348786,,2020-01-29,,,2020-09-15,2020-04-14,2020-04-16,ACTUAL,,,,,,,2020-09-15,2020-09-16,ACTUAL,2019-02-01,ACTUAL,2019-02-01,2020-09,2020-09-30,2020-09-01,ACTUAL,2020-09-01,2020-08-30,ACTUAL,2020-08-30,,INTERVENTIONAL,,,Comparing Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinadizole on Treatment Helicobacter Pylori,Comparing the Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinidazole on Rate of Eradication of Helicobacter Pylori Infected Patients on Syrian Population,COMPLETED,,PHASE4,78.0,ACTUAL,Damascus Hospital,,2.0,,,f,,,,f,f,f,,,,,,Within 5 year of study completion,,,YES,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,OTHER,,,,,,,2020,0.0
NCT01908192,,2013-07-23,,,2024-05-07,2013-07-23,2013-07-25,ESTIMATED,,,,,,,2024-05-07,2024-05-09,ACTUAL,2014-06,,2014-06-30,2024-05,2024-05-31,2023-10-26,ACTUAL,2023-10-26,2023-10-26,ACTUAL,2023-10-26,,INTERVENTIONAL,,,Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen®,"An Adaptive, Phase IIb/III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy OF NaBen® , A D-Amino Acid Oxidase Inhibitor, as an Add-on Treatment for Schizophrenia in Adolescents",TERMINATED,,PHASE2/PHASE3,60.0,ACTUAL,SyneuRx International (Taiwan) Corp,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,INDUSTRY,,,,,,,2023,0.0
NCT02042989,,2014-01-21,,,2022-07-08,2014-01-21,2014-01-23,ESTIMATED,,,,,,,2022-07-08,2022-07-11,ACTUAL,2014-06-27,ACTUAL,2014-06-27,2022-07,2022-07-31,2020-01-22,ACTUAL,2020-01-22,2020-01-22,ACTUAL,2020-01-22,,INTERVENTIONAL,,,MLN9708 and Vorinostat in Patients With Advanced p53 Mutant Malignancies,A Phase I Study of MLN9708 and Vorinostat to Target Autophagy in Patients With Advanced p53 Mutant Malignancies,COMPLETED,,PHASE1,68.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,OTHER,,,,,,,2020,1.0
NCT03743051,,2018-11-14,2024-04-18,2023-04-03,2024-06-05,2018-11-14,2018-11-15,ACTUAL,2024-06-05,2024-06-26,ACTUAL,,2024-06-26,ACTUAL,2024-06-05,2024-06-26,ACTUAL,2019-03-05,ACTUAL,2019-03-05,2024-06,2024-06-30,2023-02-11,ACTUAL,2023-02-11,2023-02-11,ACTUAL,2023-02-11,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC),"A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)",COMPLETED,,PHASE3,318.0,ACTUAL,Helsinn Healthcare SA,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2023,1.0
NCT04091750,,2019-09-13,,,2023-08-09,2019-09-13,2019-09-17,ACTUAL,,,,,,,2023-08-09,2023-08-14,ACTUAL,2020-03-02,ACTUAL,2020-03-02,2023-08,2023-08-31,2024-05,ESTIMATED,2024-05-31,2023-03-03,ACTUAL,2023-03-03,,INTERVENTIONAL,,,Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma,Phase II Study of Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma,SUSPENDED,,PHASE2,27.0,ESTIMATED,Georgetown University,,1.0,,futility stage with the first 14 subjects completed,f,,,,t,t,f,,,,,,,,,,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,OTHER,,,,,,,2024,0.0
NCT04958642,,2021-06-29,2023-08-04,2022-10-19,2023-08-04,2021-07-01,2021-07-12,ACTUAL,2023-08-04,2023-08-29,ACTUAL,2022-10-19,2022-10-24,ACTUAL,2023-08-04,2023-08-29,ACTUAL,2015-12-23,ACTUAL,2015-12-23,2023-08,2023-08-31,2022-04-11,ACTUAL,2022-04-11,2022-04-11,ACTUAL,2022-04-11,,INTERVENTIONAL,,The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.,Adrabetadex to Treat Niemann-Pick Type C1 (NPC1) Disease,"A Phase 2B/3 Prospective, Randomized, Double-Blind, Sham-Controlled Trial of VTS-270 (2-hydroxypropyl-β-cyclodextrin) in Subjects With Neurologic Manifestations of Niemann-Pick Type C1 (NPC1) Disease",TERMINATED,,PHASE2/PHASE3,66.0,ACTUAL,Mandos LLC,The development program for adrabetadex was discontinued and Part C of the study was terminated by the Sponsor.,1.0,,Terminated by previous Sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,INDUSTRY,,,,,,,2022,0.0
NCT04316611,,2020-02-07,,,2024-01-18,2020-03-18,2020-03-20,ACTUAL,,,,,,,2024-01-18,2024-01-19,ACTUAL,2023-12,ESTIMATED,2023-12-31,2024-01,2024-01-31,2024-12,ESTIMATED,2024-12-31,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,POTACREH,,Potassium Chloride in Out-of-hospital Cardiac Arrest Due to Refractory Ventricular Fibrillation,Evaluation of the Effectiveness of Potassium Chloride in the Management of Out-of-hospital Cardiac Arrest by Refractory Ventricular Fibrillation,WITHDRAWN,,PHASE2,0.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,1.0,,"As the inclusion period in the study has ended and regulatory authorizations have expired on 26/12/2023, with no inclusions conducted.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,OTHER,,,,,,,2024,0.0
NCT05666453,,2022-12-17,,,2024-08-29,2022-12-17,2022-12-27,ACTUAL,,,,,,,2024-08-29,2024-08-30,ACTUAL,2022-04-25,ACTUAL,2022-04-25,2024-08,2024-08-31,2024-07-01,ACTUAL,2024-07-01,2024-05-07,ACTUAL,2024-05-07,,INTERVENTIONAL,,,A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in ABO-Incompatible Liver Transplantation,"A Multi-center, Prospective, Randomized, Controlled, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Immunoglobulin to Prevent Biliary Complications After ABO Incompatible Adult to Adult Living Donor Liver Transplantation",TERMINATED,,PHASE2,59.0,ACTUAL,"SK Plasma Co., Ltd.",,3.0,,Change of Clincal Development Plan,f,,,,f,f,f,,,f,,,,,,,,2024-10-15 13:54:14.880753,2024-10-15 13:54:14.880753,INDUSTRY,,,,,,,2024,0.0
NCT01741038,,2012-11-29,,,2020-01-17,2012-11-30,2012-12-04,ESTIMATED,,,,,,,2020-01-17,2020-01-22,ACTUAL,2017-12,ESTIMATED,2017-12-31,2016-08,2016-08-31,2020-10,ESTIMATED,2020-10-31,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,AlloStim® In-Situ Vaccine in Pre-Treated Metastatic Colorectal Cancer,"A Phase II/III, Randomized, Open Label, Controlled, Two Arm Study Comparing Overall Survival of AlloStim® Combined With Cryoablation to a Physician's Choice Combined With Cryoablation in 3rd Line Treatment for Metastatic Colorectal Cancer",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,"Mirror Biologics, Inc.",,2.0,,moved study to USA,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2020,0.0
NCT03730961,,2018-11-01,2020-12-10,,2021-02-24,2018-11-02,2018-11-05,ACTUAL,2021-01-06,2021-01-26,ACTUAL,,,,2021-02-24,2021-02-26,ACTUAL,2019-01-17,ACTUAL,2019-01-17,2021-02,2021-02-28,2020-01-09,ACTUAL,2020-01-09,2019-12-11,ACTUAL,2019-12-11,,INTERVENTIONAL,,,An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic,"A Randomized, Double-Blind, Placebo-Controlled, Cross-over Phase 2 Study of Continuous 8-Hour Intravenous Infusions of BMS-986231 in Patients With Heart Failure and Impaired Systolic Function Given a Standard Dose of Loop Diuretic",COMPLETED,,PHASE2,23.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,,t,f,,,t,,,,,,,,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,INDUSTRY,,,,,,,2020,1.0
NCT03399786,,2018-01-08,2021-02-12,2020-05-28,2021-04-26,2018-01-08,2018-01-16,ACTUAL,2021-04-26,2021-05-18,ACTUAL,2021-04-26,2021-05-18,ACTUAL,2021-04-26,2021-05-18,ACTUAL,2018-01-18,ACTUAL,2018-01-18,2021-04,2021-04-30,2020-03-17,ACTUAL,2020-03-17,2019-06-10,ACTUAL,2019-06-10,,INTERVENTIONAL,,,Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia,"A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia",COMPLETED,,PHASE3,65.0,ACTUAL,Regeneron Pharmaceuticals,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,INDUSTRY,,,,,,,2020,1.0
NCT02736552,,2016-04-04,,,2019-05-06,2016-04-07,2016-04-13,ESTIMATED,,,,,,,2019-05-06,2019-05-08,ACTUAL,2016-03,,2016-03-31,2019-05,2019-05-31,2023-03,ESTIMATED,2023-03-31,2019-03,ESTIMATED,2019-03-31,,INTERVENTIONAL,,,"Compare S-1 for 6 Months to 1 Year as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer Staged II , IIIA or IIIB.","A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 for 6 Months to 1 Year as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer Staged II , IIIA or IIIB.",WITHDRAWN,,PHASE3,0.0,ACTUAL,Fudan University,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,OTHER,,,,,,,2023,0.0
NCT03476928,,2018-03-20,,,2022-07-06,2018-03-20,2018-03-26,ACTUAL,,,,,,,2022-07-06,2022-07-08,ACTUAL,2018-03-30,ACTUAL,2018-03-30,2022-06,2022-06-30,2021-07-12,ACTUAL,2021-07-12,2021-07-12,ACTUAL,2021-07-12,,INTERVENTIONAL,ASTEROID 8,,A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding,"An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding",TERMINATED,,PHASE3,153.0,ACTUAL,Bayer,,2.0,,"Due to a change in the development program, the study was closed prematurely.",f,,,,f,f,f,,,,,,,,,UNDECIDED,"Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,INDUSTRY,,,,,,,2021,0.0
NCT06024174,,2023-08-29,,,2024-06-07,2023-08-29,2023-09-06,ACTUAL,,,,,,,2024-06-07,2024-06-10,ACTUAL,2023-11-09,ACTUAL,2023-11-09,2024-05,2024-05-31,2024-05-13,ACTUAL,2024-05-13,2024-05-13,ACTUAL,2024-05-13,,INTERVENTIONAL,,,A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors,Phase 1/2 Open-label Study of BMS-986466 in Combination With Adagrasib With or Without Cetuximab in Participants With KRAS G12C-mutant Advanced Solid Tumors,TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,Bristol-Myers Squibb,,3.0,,Business objectives have changed,f,,,,f,t,f,,,,,,See Plan Description,See Plan Description,https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html,YES,"BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html",2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2024,0.0
NCT02509052,,2015-07-23,2021-10-07,,2023-09-15,2015-07-23,2015-07-27,ESTIMATED,2023-09-15,2023-10-10,ACTUAL,,,,2023-09-15,2023-10-10,ACTUAL,2015-12-02,ACTUAL,2015-12-02,2023-09,2023-09-30,2022-06-09,ACTUAL,2022-06-09,2018-09-18,ACTUAL,2018-09-18,,INTERVENTIONAL,,"Because we obtained preclinical data indicating a synergistic effect between leflunomide and lenalidomide, we determined that investigating leflunomide-based combinational therapy was favorable over pursuing a phase 2 study of single-agent leflunomide. There were no dose de-escalations, so there were no patients accrued to the arms for 10mg, 30mg, or 50mg.",Leflunomide in Treating Patients With Relapsed or Refractory Multiple Myeloma,A Phase I/II Dose-Escalation Trial of Leflunomide in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma,COMPLETED,,PHASE1/PHASE2,12.0,ACTUAL,City of Hope Medical Center,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,OTHER,,,,,,,2022,1.0
NCT02530502,,2015-08-19,,,2023-11-16,2015-08-20,2015-08-21,ESTIMATED,,,,,,,2023-11-16,2023-11-18,ACTUAL,2015-09-30,ACTUAL,2015-09-30,2023-11,2023-11-30,2020-02-12,ACTUAL,2020-02-12,2016-05-10,ACTUAL,2016-05-10,,INTERVENTIONAL,,,Radiation Therapy With Temozolomide and Pembrolizumab in Treating Patients With Newly Diagnosed Glioblastoma,Phase I Trial of Radiation Therapy Plus Temozolomide With MK-3475 in Patients With Newly Diagnosed Glioblastoma (GBM),TERMINATED,,PHASE1,4.0,ACTUAL,Northwestern University,,1.0,,The protocol was amendment to be stopped after phase I (phase 2 removed from protocol),f,,,,t,,,,,,,,,,,,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,OTHER,,,,,,,2020,0.0
NCT03207815,,2017-06-30,2021-12-23,,2021-12-23,2017-06-30,2017-07-05,ACTUAL,2021-12-23,2022-01-21,ACTUAL,,,,2021-12-23,2022-01-21,ACTUAL,2017-07-26,ACTUAL,2017-07-26,2021-12,2021-12-31,2021-04-22,ACTUAL,2021-04-22,2020-12-29,ACTUAL,2020-12-29,,INTERVENTIONAL,HUMBOLDT,Safety Analysis Set included all participants who received at least 1 dose of study drug.,Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis,"A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis",TERMINATED,,PHASE2,74.0,ACTUAL,Gilead Sciences,"Study was terminated early due to termination of the development program. Due to early termination and small sample size, pharmacokinetic (PK) analysis was not performed for this study.",2.0,,Development program terminated,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2021,0.0
NCT02054559,,2014-01-29,,,2016-02-20,2014-02-02,2014-02-04,ESTIMATED,,,,,,,2016-02-20,2016-02-23,ESTIMATED,,,,2016-02,2016-02-29,2020-01,ESTIMATED,2020-01-31,2020-01,ESTIMATED,2020-01-31,,INTERVENTIONAL,ASPIRE,,R-CHOP Alone vs. R-CHOP Plus Radiotherapy for Localized CD20+ DLBCL,Randomized Phase III Trial Comparing R-CHOP Alone and R-CHOP Plus Radiotherapy for Localized CD20+ Diffuse Large B-cell Lymphoma (DLBCL),WITHDRAWN,,PHASE3,0.0,ACTUAL,Asan Medical Center,,2.0,,No consensus among trial centers regarding protocol,f,,,,t,,,,,,,,,,,,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,OTHER,,,,,,,2020,0.0
NCT04036461,,2019-07-25,,,2024-08-28,2019-07-25,2019-07-29,ACTUAL,,,,,,,2024-08-28,2024-08-30,ACTUAL,2019-08-26,ACTUAL,2019-08-26,2024-08,2024-08-31,2024-08-19,ACTUAL,2024-08-19,2024-07-08,ACTUAL,2024-07-08,,INTERVENTIONAL,,,"A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma","A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma",TERMINATED,,PHASE1,47.0,ACTUAL,Celgene,,2.0,,Slow accrual,f,,,,f,t,f,,,,,,See Plan Description,See Plan Description,https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,INDUSTRY,,,,,,,2024,0.0
NCT05676853,,2022-12-21,,,2023-07-25,2023-01-06,2023-01-09,ACTUAL,,,,,,,2023-07-25,2023-07-27,ACTUAL,2023-04-04,ACTUAL,2023-04-04,2023-07,2023-07-31,2023-04-27,ACTUAL,2023-04-27,2023-04-27,ACTUAL,2023-04-27,,INTERVENTIONAL,,,A Study of Safety of Weekly Subcutaneous Pegzilarginase in Subjects With Arginase 1 Deficiency,A Phase 3 Open-Label Study of Safety of Weekly Subcutaneous Pegzilarginase in Subjects With Arginase 1 Deficiency,TERMINATED,,PHASE3,3.0,ACTUAL,Aeglea Biotherapeutics,,1.0,,Sponsor Decision,,,,,,t,f,,,,,,,,,,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,INDUSTRY,,,,,,,2023,0.0
NCT02824354,,2016-06-29,,,2023-07-18,2016-07-01,2016-07-06,ESTIMATED,,,,,,,2023-07-18,2023-07-20,ACTUAL,2018-12-01,ACTUAL,2018-12-01,2023-07,2023-07-31,2022-12-01,ACTUAL,2022-12-01,2022-12-01,ACTUAL,2022-12-01,,INTERVENTIONAL,NalmeCir,,Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.,"Multicentre, Randomised, Double-blind, Placebo-controlled Trial of Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Centre Hospitalier Universitaire, Amiens",,2.0,,no participants enrolled,f,,,,f,f,f,,,,,,,,,,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,OTHER,,,,,,,2022,0.0
NCT03595982,,2018-07-11,2022-06-05,,2022-06-05,2018-07-11,2018-07-23,ACTUAL,2022-06-05,2022-06-30,ACTUAL,,,,2022-06-05,2022-06-30,ACTUAL,2018-09-15,ACTUAL,2018-09-15,2022-06,2022-06-30,2020-02-20,ACTUAL,2020-02-20,2020-02-20,ACTUAL,2020-02-20,,INTERVENTIONAL,,,Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily?,Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily?,TERMINATED,,PHASE4,5.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,2.0,,Low enrollment,f,,,,f,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,OTHER,,,,,,,2020,0.0
NCT04242498,,2020-01-23,,2022-11-08,2023-10-16,2020-01-23,2020-01-27,ACTUAL,,,,2022-11-08,2022-11-10,ACTUAL,2023-10-16,2023-10-17,ACTUAL,2020-03-02,ACTUAL,2020-03-02,2023-10,2023-10-31,2022-09-28,ACTUAL,2022-09-28,2021-11-09,ACTUAL,2021-11-09,,INTERVENTIONAL,BE HEARD II,,A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa",COMPLETED,,PHASE3,509.0,ACTUAL,UCB Pharma,,4.0,,,f,,,,t,t,f,,,f,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",http://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-16 20:59:50.237862,2024-10-16 20:59:50.237862,INDUSTRY,,,,,,,2022,1.0
NCT03697109,,2018-09-27,,,2024-08-27,2018-10-03,2018-10-05,ACTUAL,,,,,,,2024-08-27,2024-08-29,ACTUAL,2018-11-15,ACTUAL,2018-11-15,2024-08,2024-08-31,2024-04-15,ACTUAL,2024-04-15,2024-04-08,ACTUAL,2024-04-08,,INTERVENTIONAL,GRACE,,A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome,"Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant",COMPLETED,,PHASE3,152.0,ACTUAL,Corcept Therapeutics,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,INDUSTRY,,,,,,,2024,1.0
NCT05514002,,2022-08-08,,,2024-05-13,2022-08-22,2022-08-24,ACTUAL,,,,,,,2024-05-13,2024-05-14,ACTUAL,2022-09-13,ACTUAL,2022-09-13,2024-05,2024-05-31,2023-12-31,ACTUAL,2023-12-31,2023-12-31,ACTUAL,2023-12-31,,INTERVENTIONAL,,,Comparison of Recombinant Influenza Vaccine Versus Standard Egg-Based Inactivated Influenza Vaccine in Adults 18-64 Years,Randomized Participant- and Investigator-Blinded Trial to Compare the Clinical Efficacy of Recombinant Influenza Vaccine to Standard Dose Egg-Based Inactivated Influenza Vaccine Among Adults Aged 18-64 Years in the United States,TERMINATED,,PHASE4,3988.0,ACTUAL,Centers for Disease Control and Prevention,,2.0,,Insufficient funding.,f,,,,f,t,f,,,t,,,Upon the completion of all study deliverables and dissemination of analyses to meet the protocol objectives.,,,YES,"Upon the completion of all study deliverables and after a suitable moratorium, external parties may request de-identified study data from the steering committee as specified in U.S. Government Data Sharing guidelines.",2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,FED,,,,,,,2023,0.0
NCT02220855,,2014-08-07,2018-08-09,,2022-03-14,2014-08-19,2014-08-20,ESTIMATED,2018-11-27,2018-12-19,ACTUAL,,,,2022-03-14,2022-04-11,ACTUAL,2014-10-01,ACTUAL,2014-10-01,2022-03,2022-03-31,2021-03-09,ACTUAL,2021-03-09,2017-03-27,ACTUAL,2017-03-27,,INTERVENTIONAL,,,A Study of BKM120 (Buparlisib) in Relapsed or Refractory Thymomas,A Phase II Study of BKM120 (Buparlisib) in Relapsed or Refractory Thymomas,COMPLETED,,PHASE2,14.0,ACTUAL,Indiana University,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,OTHER,,,,,,,2021,0.0
NCT03894969,,2019-03-27,2021-08-30,,2024-09-09,2019-03-27,2019-03-29,ACTUAL,2021-08-30,2021-09-27,ACTUAL,,,,2024-09-09,2024-09-23,ACTUAL,2019-04-23,ACTUAL,2019-04-23,2024-09,2024-09-30,2021-08-13,ACTUAL,2021-08-13,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,,,Study to Assess the Immunogenicity and Safety of GSK's Investigational Vaccine (GSK3277511A) When Given to Healthy Smokers and Ex-smokers After Administration of Shingrix Vaccine,Immunogenicity and Safety Study of GSK's Investigational Vaccine (GSK3277511A) When Administered in Healthy Smokers and Ex-smokers Following Receipt of Shingrix Vaccine,COMPLETED,,PHASE2,541.0,ACTUAL,GlaxoSmithKline,,5.0,,,f,,,,f,t,f,,,,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf,YES,"GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf",2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,INDUSTRY,,,,,,,2021,1.0
NCT05179603,,2021-12-16,,2024-09-12,2024-09-18,2021-12-16,2022-01-05,ACTUAL,,,,,2024-03-28,ACTUAL,2024-09-18,2024-09-20,ACTUAL,2021-12-07,ACTUAL,2021-12-07,2024-09,2024-09-30,2024-09-06,ACTUAL,2024-09-06,2023-09-14,ACTUAL,2023-09-14,,INTERVENTIONAL,,,A Study of SAR444245 With or Without Other Anticancer Therapies for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Lymphoma (Master Protocol) [Pegathor Lymphoma 205],"Phase 2 Non-randomized, Open-label, Multi-cohort, Multicenter Study Assessing the Clinical Benefit of SAR444245 (THOR-707) With or Without Other Anticancer Therapies for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Lymphoma",TERMINATED,,PHASE2,14.0,ACTUAL,Sanofi,,2.0,,Early discontinuation based on strategic sponsor decision not driven by any safety concerns.,,,,,t,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,INDUSTRY,,,,,,,2024,0.0
NCT05243563,,2022-02-07,,,2024-09-19,2022-02-07,2022-02-17,ACTUAL,,,,,,,2024-09-19,2024-09-23,ACTUAL,2022-04-13,ACTUAL,2022-04-13,2023-12,2023-12-31,2024-06-03,ACTUAL,2024-06-03,2024-06-03,ACTUAL,2024-06-03,,INTERVENTIONAL,,,Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone?,"A Randomized, Unblinded Trial of Topical Steroids Plus CO2 Laser Compared to Steroids Alone in the Treatment of Vulvovaginal Lichen Sclerosus",TERMINATED,,PHASE2/PHASE3,11.0,ACTUAL,University of South Alabama,,2.0,,Inability to obtain recruitment levels needed for study to continue.,f,,,,f,t,t,,,f,,,,,,NO,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,OTHER,,,,,,,2024,0.0
NCT04530448,,2020-08-20,2022-09-13,,2023-12-04,2020-08-26,2020-08-28,ACTUAL,2023-12-04,2023-12-22,ACTUAL,,,,2023-12-04,2023-12-22,ACTUAL,2020-10-05,ACTUAL,2020-10-05,2023-12,2023-12-31,2021-07-15,ACTUAL,2021-07-15,2021-07-15,ACTUAL,2021-07-15,,INTERVENTIONAL,,"Unable to recruit enough subjects to complete the study. Only 3 subjects enrolled. However, those subjects did not complete the study as the PI terminated the study.",Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization,Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization,TERMINATED,,PHASE4,3.0,ACTUAL,West Virginia University,,2.0,,"Unable to recruit enough subjects to complete the study. Only 3 subjects enrolled. However, those subjects did not complete the study as the PI terminated the study and data was not collected.",f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,OTHER,,,,,,,2021,0.0
NCT02026089,,2013-12-23,,,2021-02-04,2013-12-30,2014-01-01,ESTIMATED,,,,,,,2021-02-04,2021-02-09,ACTUAL,2021-12,ESTIMATED,2021-12-31,2021-02,2021-02-28,2022-06,ESTIMATED,2022-06-30,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,Persistence of Varicella Immunity in Hospital Employees Receiving Varicella Vaccine,Persistence of Varicella Immunity in Hospital Employees Receiving Varicella Vaccine,WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of Colorado, Denver",,2.0,,Unforeseen reduction of recruitment resource.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,OTHER,,,,,,,2022,0.0
NCT03330405,,2017-10-16,2023-02-10,,2023-10-11,2017-10-30,2017-11-06,ACTUAL,2023-05-17,2023-06-12,ACTUAL,,,,2023-10-11,2023-10-13,ACTUAL,2017-10-19,ACTUAL,2017-10-19,2023-10,2023-10-31,2023-01-04,ACTUAL,2023-01-04,2022-02-22,ACTUAL,2022-02-22,,INTERVENTIONAL,,,Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors,A PHASE 1B/2 STUDY TO EVALUATE SAFETY AND ANTI TUMOR ACTIVITY OF AVELUMAB IN COMBINATION WITH THE POLY(ADENOSINE DIPHOSPHATE [ADP]-RIBOSE) POLYMERASE (PARP) INHIBITOR TALAZOPARIB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS,TERMINATED,,PHASE1/PHASE2,223.0,ACTUAL,Pfizer,,13.0,,The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the investigational treatments have been moved to a continuation study (NCT05059522).,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,INDUSTRY,,,,,,,2023,0.0
NCT04409145,,2020-05-11,,,2022-08-01,2020-05-26,2020-06-01,ACTUAL,,,,,,,2022-08-01,2022-08-04,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2022-08,2022-08-31,2022-04-13,ACTUAL,2022-04-13,2022-04-13,ACTUAL,2022-04-13,,INTERVENTIONAL,,,First in Human Trial of Topical VT30 in Pts With Venous/Lymphatic Malformations Assoc With PIK3CA or TEK Gene Mutations,"Open-Label, Intra Subject, Dose Escalation (Part 1) Followed by Randomized, Double Blind, Placebo Controlled (Part 2) Trial of Topical VT30 in Pts With Venous, Lymphatic or Mixed Malformations Associated With PIK3CA or TEK Genetic Mutations",TERMINATED,,PHASE1/PHASE2,15.0,ACTUAL,"Venthera, Inc., a BridgeBio company",,1.0,,Part 1 complete; Part 2 will not be completed.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,INDUSTRY,,,,,,,2022,0.0
NCT03661983,,2018-09-05,2020-12-23,,2021-02-16,2018-09-05,2018-09-07,ACTUAL,2020-12-23,2021-01-22,ACTUAL,,,,2021-02-16,2021-03-09,ACTUAL,2018-10-13,ACTUAL,2018-10-13,2021-02,2021-02-28,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,The Enrolled Sample included all participants who entered the open-label stabilization phase.,Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Participants With Tourette's Disorder,"A Randomized, Placebo-controlled Trial to Evaluate the Long-term (ie, Maintenance) Efficacy of Oral Aripiprazole in the Treatment of Pediatric Subjects With Tourette's Disorder",TERMINATED,,PHASE4,36.0,ACTUAL,"Otsuka Pharmaceutical Development & Commercialization, Inc.",This trial was terminated early due to the withdrawal of post-marketing commitment (PMC) to FDA. The planned interim analysis was not conducted either.,4.0,,Lack of feasibility for completion of the trial within a reasonable time frame.,f,,,,t,t,f,,,,,,"Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.",Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com,http://clinical-trials.otsuka.com,YES,Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,INDUSTRY,,,,,,,2020,0.0
NCT04524026,,2018-09-07,,,2021-01-13,2020-08-21,2020-08-24,ACTUAL,,,,,,,2021-01-13,2021-01-14,ACTUAL,2018-09-18,ACTUAL,2018-09-18,2021-01,2021-01-31,2020-11-30,ACTUAL,2020-11-30,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,RIOTC,,RIOTC: Reducing the Impact of Ovarian Stimulation. Novel Approaches to Luteal Support in IVF-Study 2,RIOTC: Reducing the Impact of Ovarian Stimulation. Novel Approaches to Luteal Support in IVF - Study 2,COMPLETED,,PHASE2,25.0,ACTUAL,Zealand University Hospital,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,OTHER,,,,,,,2020,1.0
NCT04385589,,2020-05-09,,,2022-02-15,2020-05-12,2020-05-13,ACTUAL,,,,,,,2022-02-15,2022-02-16,ACTUAL,2020-05-01,ACTUAL,2020-05-01,2022-02,2022-02-28,2020-12-20,ACTUAL,2020-12-20,2020-12-15,ACTUAL,2020-12-15,,INTERVENTIONAL,,,Dapagliflozin in Diabetic Patients (Type 2) With Decompensated Heart Failure,Safety and Efficacy of Adding Dapagliflozin and Furosemide in Diabetic Patients (Type 2) With Decompensated Heart Failure With Reduced Ejection Fraction (HFrEF),COMPLETED,,PHASE4,100.0,ACTUAL,Assiut University,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,OTHER,,,,,,,2020,1.0
NCT03380546,,2017-11-07,,,2024-07-02,2017-12-20,2017-12-21,ACTUAL,,,,,,,2024-07-02,2024-07-03,ACTUAL,2018-07-04,ACTUAL,2018-07-04,2024-07,2024-07-31,2024-02-22,ACTUAL,2024-02-22,2023-08-12,ACTUAL,2023-08-12,,INTERVENTIONAL,ACARB-GDM,,Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus.,Non-inferiority Between Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial. ACARB-GDM Study.,TERMINATED,,PHASE3,341.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,difficulty in recruiting,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,OTHER,,,,,,,2024,0.0
NCT04188379,,2019-12-04,,2023-02-02,2024-03-04,2019-12-04,2019-12-05,ACTUAL,,,,2023-02-02,2023-02-09,ACTUAL,2024-03-04,2024-03-07,ACTUAL,2019-12-16,ACTUAL,2019-12-16,2024-03,2024-03-31,2022-02-03,ACTUAL,2022-02-03,2022-02-03,ACTUAL,2022-02-03,,INTERVENTIONAL,ADVANCE,,A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).,"A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia",COMPLETED,,PHASE3,131.0,ACTUAL,argenx,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,INDUSTRY,,,,,,,2022,1.0
NCT03334851,,2017-11-03,2023-01-10,,2023-01-10,2017-11-03,2017-11-07,ACTUAL,2023-01-10,2023-10-30,ACTUAL,,,,2023-01-10,2023-10-30,ACTUAL,2017-11-17,ACTUAL,2017-11-17,2023-01,2023-01-31,2022-02-15,ACTUAL,2022-02-15,2022-02-15,ACTUAL,2022-02-15,,INTERVENTIONAL,,Baseline analysis population included all enrolled participants who received at least one dose of study treatment.,Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis,"A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS",COMPLETED,,PHASE1,74.0,ACTUAL,Pfizer,,14.0,,,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,INDUSTRY,,,,,,,2022,1.0
NCT04834310,,2021-04-03,,,2022-09-09,2021-04-05,2021-04-08,ACTUAL,,,,,,,2022-09-09,2022-09-14,ACTUAL,2021-04-01,ESTIMATED,2021-04-01,2022-09,2022-09-30,2024-07-30,ESTIMATED,2024-07-30,2024-05-30,ESTIMATED,2024-05-30,,INTERVENTIONAL,,,Postoperative Antibiotics Following Primary and Secondary Breast Augmentation,"Postoperative Antibiotics Following Primary and Secondary Breast Augmentation: A Double-Blinded, Randomized Trial",WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of California, Los Angeles",,2.0,,Do not have adequate funding to proceed with project.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,OTHER,,,,,,,2024,0.0
NCT05074888,,2021-10-05,2023-10-19,,2024-05-21,2021-10-08,2021-10-12,ACTUAL,2024-05-21,2024-09-23,ACTUAL,,,,2024-05-21,2024-09-23,ACTUAL,2021-10-15,ACTUAL,2021-10-15,2023-01,2023-01-31,2022-06-08,ACTUAL,2022-06-08,2022-06-08,ACTUAL,2022-06-08,,INTERVENTIONAL,,,Сlinical Trial of Efficacy and Safety of Prospekta in the Treatment of Post-COVID-19 Asthenia.,"A Multicenter, Double-blind, Placebo-controlled, Parallel-group, Randomized Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Patients With Post-COVID-19 Asthenia.",COMPLETED,,PHASE3,676.0,ACTUAL,Materia Medica Holding,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,INDUSTRY,,,,,,,2022,1.0
NCT02316002,,2014-12-10,2019-10-14,,2024-01-31,2014-12-11,2014-12-12,ESTIMATED,2019-11-07,2019-11-12,ACTUAL,,,,2024-01-31,2024-02-02,ACTUAL,2015-01-21,ACTUAL,2015-01-21,2024-01,2024-01-31,2022-12,ACTUAL,2022-12-31,2018-09-30,ACTUAL,2018-09-30,,INTERVENTIONAL,,,Phase II Study of Pembrolizumab After Curative Intent Treatment for Oligometastatic Non-Small Cell Lung Cancer,Phase II Study of Pembrolizumab After Curative Intent Treatment for Oligometastatic Non-Small Cell Lung Cancer,COMPLETED,,PHASE2,51.0,ACTUAL,Abramson Cancer Center at Penn Medicine,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,OTHER,,,,,,,2022,1.0
NCT03661424,,2018-08-22,,,2022-12-15,2018-09-04,2018-09-07,ACTUAL,,,,,,,2022-12-15,2022-12-20,ACTUAL,2019-02-26,ACTUAL,2019-02-26,2022-12,2022-12-31,2021-12-14,ACTUAL,2021-12-14,2021-12-14,ACTUAL,2021-12-14,,INTERVENTIONAL,,,BATs in Patients With Breast Cancer and Leptomeningeal Metastases,A Phase I Study of Anti-CD3 x Anti-Her2/Neu (Her2Bi) Armed Activated T Cells (ATC) in Patients With Breast Cancer Leptomeningeal Metastases,TERMINATED,,PHASE1,3.0,ACTUAL,University of Virginia,,1.0,,"slow study accrual, partially due to pandemic",f,,,,t,t,f,,,,,,,,,NO,,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,OTHER,,,,,,,2021,0.0
NCT03307603,,2017-09-07,,,2018-02-24,2017-10-06,2017-10-11,ACTUAL,,,,,,,2018-02-24,2018-02-27,ACTUAL,2018-12,ESTIMATED,2018-12-31,2018-02,2018-02-28,2021-03,ESTIMATED,2021-03-31,2019-03,ESTIMATED,2019-03-31,,INTERVENTIONAL,,,Yttrium-90 Radioembolization + Nivolumab for Liver + Extra-hepatic Metastases From Colorectal Cancer,A Phase Ib/II Study of Yttrium-90 Radioembolization With Nivolumab for Treatment of Liver and Extra-hepatic Metastases From Colorectal Cancer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Case Comprehensive Cancer Center,,1.0,,Sponsor chose not to continue,f,,,,t,t,f,,,f,,,,,,,,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,OTHER,,,,,,,2021,0.0
NCT03367819,,2017-12-05,2022-03-08,,2022-04-21,2017-12-05,2017-12-11,ACTUAL,2022-04-21,2022-05-16,ACTUAL,,,,2022-04-21,2022-05-16,ACTUAL,2018-01-04,ACTUAL,2018-01-04,2022-04,2022-04-30,2021-03-10,ACTUAL,2021-03-10,2021-03-10,ACTUAL,2021-03-10,,INTERVENTIONAL,,"Analysis was performed on all-treated population which included all participants who signed the study informed consent (IC) and received at least 1 dose (even incomplete) of the study treatments, either isatuximab or REGN2810.",Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies,"A Phase 1/2 Open-label, Multi-center, Safety, Preliminary Efficacy and Pharmacokinetic (PK) Study of Isatuximab (SAR650984) in Combination With REGN2810, or Isatuximab Alone, in Patients With Advanced Malignancies",TERMINATED,,PHASE1/PHASE2,44.0,ACTUAL,Sanofi,The study was terminated after the interim analysis of the primary endpoint. Few planned outcome measures per-protocol were not analyzed because overall efficacy results were not sufficient at the time of interim analyses of both the cohorts.,6.0,,"The study was stopped after interim analysis indicated that overall result was not sufficient to satisfy per-protocol criteria to move forward in metastatic, castration-resistant prostate cancer (mCRPC) and non-small cell lung cancer (NSCLC) cohorts.",f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,INDUSTRY,,,,,,,2021,0.0
NCT05648006,,2022-12-05,,,2024-04-28,2022-12-05,2022-12-13,ACTUAL,,,,,,,2024-04-28,2024-04-30,ACTUAL,2023-10-17,ACTUAL,2023-10-17,2024-04,2024-04-30,2024-04-15,ACTUAL,2024-04-15,2024-04-15,ACTUAL,2024-04-15,,INTERVENTIONAL,,,First-line Maintenance of OH2 Injection for Advanced Colorectal Cancer,"A Prospective, Multicenter, Open, Randomized Controlled Phase II Clinical Study Evaluating Recombinant Oncolytic HSV2（OH2）Therapeutic Injecta(Vero Cell) for Human Use(rHSV2hGM-CSF) in Combination With Capecitabine for First-line Maintenance Therapy in Advanced Colorectal Cancer",TERMINATED,,PHASE2,7.0,ACTUAL,"Binhui Biopharmaceutical Co., Ltd.",,2.0,,Strategy adjustment,f,,,,,f,f,,,,,,,,,,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,INDUSTRY,,,,,,,2024,0.0
NCT04022057,,2019-07-08,,,2024-06-04,2019-07-12,2019-07-16,ACTUAL,,,,,,,2024-06-04,2024-06-06,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2024-06,2024-06-30,2020-03-15,ACTUAL,2020-03-15,2020-03-15,ACTUAL,2020-03-15,,INTERVENTIONAL,,,The Impact of a Preoperative Nerve Block in Foot and Ankle Surgery on the Consumption of Sevoflurane,The Impact of a Preoperative Nerve Block in Foot and Ankle Surgery on the Consumption of Sevoflurane,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,University of Alberta,,2.0,,COVID-19 Pandemic,f,,,,f,f,f,,,,,,,,,,,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,OTHER,,,,,,,2020,0.0
NCT03784599,,2018-10-31,,,2022-11-07,2018-12-21,2018-12-24,ACTUAL,,,,,,,2022-11-07,2022-11-10,ACTUAL,2018-12-18,ACTUAL,2018-12-18,2022-11,2022-11-30,2021-05-17,ACTUAL,2021-05-17,2021-05-17,ACTUAL,2021-05-17,,INTERVENTIONAL,TRAEMOS,,T-DM1 and Osimertinib Combination Treatment to Target HER2 Bypass Track Resistance in EGFR Mutation Positive NSCLC,Trastuzumab-emtansine and Osimertinib Combination Treatment to Target HER2 Bypass Track Resistance in EGFR Mutation Positive NSCLC,TERMINATED,,PHASE2,28.0,ACTUAL,The Netherlands Cancer Institute,,1.0,,insufficient effectiveness,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,OTHER,,,,,,,2021,0.0
NCT03382834,,2017-12-19,2019-12-02,,2024-06-06,2017-12-19,2017-12-26,ACTUAL,2019-12-02,2019-12-18,ACTUAL,,,,2024-06-06,2024-07-03,ACTUAL,2018-04-26,ACTUAL,2018-04-26,2023-08,2023-08-31,2023-07-27,ACTUAL,2023-07-27,2018-12-04,ACTUAL,2018-12-04,,INTERVENTIONAL,,All enrolled participants,Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors,Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors,COMPLETED,,PHASE2,31.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,t,t,f,,,,,,Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by the NIH.,With whom?~Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~For what types of analyses?~To achieve aims in the proposal approved by the AIDS Clinical Trials Group. By what mechanism will data be made available?~Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at: https://submit.mis.s-3.net/. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.,,YES,"Individual participant data that underlie results in the publication, after deidentification.",2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,NIH,,,,,,,2023,1.0
NCT05159531,,2021-11-03,,,2024-04-16,2021-12-06,2021-12-16,ACTUAL,,,,,,,2024-04-16,2024-04-18,ACTUAL,2023-05-01,ACTUAL,2023-05-01,2024-04,2024-04-30,2023-06-08,ACTUAL,2023-06-08,2023-06-08,ACTUAL,2023-06-08,,INTERVENTIONAL,VPrEP,,Virtual PrEP: Rendering PrEP Delivery More Efficient,Virtual PrEP: Rendering PrEP Delivery More Efficient Using an mHealth Intervention and TAF/FTC,TERMINATED,,PHASE4,2.0,ACTUAL,Unity Health Toronto,,2.0,,Funding withdrawn,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,OTHER,,,,,,,2023,0.0
NCT04200651,,2019-12-12,2023-11-13,,2024-01-07,2019-12-12,2019-12-16,ACTUAL,2024-01-07,2024-01-31,ACTUAL,,,,2024-01-07,2024-01-31,ACTUAL,2020-01-13,ACTUAL,2020-01-13,2024-01,2024-01-31,2023-07-12,ACTUAL,2023-07-12,2023-07-12,ACTUAL,2023-07-12,,INTERVENTIONAL,SUSTAIN,"24 eyes from 20 subjects were consented and met criteria for the study (see Participant Flow Overview). However, prior to full baseline assessment and prior to surgery, 6 eyes from 4 subjects dropped out, leaving 18 eyes from 16 subjects. Additionally, given that a mixed-eye sample can impact statistical assumptions of independence, baseline data comparisons were separated between single eyes and fellow-eyes.",Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery,Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery,TERMINATED,,PHASE4,25.0,ACTUAL,The New York Eye Surgery Center,"Early termination related to COVID-19 recruitment difficulties and loss to follow-up leading to small numbers of eyes analyzed. Length of follow-up limited to 3 months. Use of only three types of minimally invasive glaucoma surgery. Single-site, single-surgeon, open-label design.",2.0,,COVID-19 challenges to recruitment,,,,,t,t,f,,,,,,,,,NO,There is not a plan to make IPD available.,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,OTHER,,,,,Eyes,,2023,0.0
NCT04372979,,2020-04-24,,,2022-04-06,2020-04-29,2020-05-04,ACTUAL,,,,,,,2022-04-06,2022-04-14,ACTUAL,2020-09-14,ACTUAL,2020-09-14,2022-04,2022-04-30,2021-06-01,ACTUAL,2021-06-01,2021-06-01,ACTUAL,2021-06-01,,INTERVENTIONAL,PLASCOSSA,,Efficacy of Convalescent Plasma Therapy in the Early Care of COVID-19 Patients.,Evaluation Of Efficacy Of COVID-19 Convalescent Plasma Versus Standard Plasma In The Early Care Of COVID-19 Patients Hospitalized Outside Intensive Care Units.,TERMINATED,,PHASE3,18.0,ACTUAL,Direction Centrale du Service de Santé des Armées,,2.0,,Reluctance of patients and physicians in this transfusion study setting. Blood products have expired. New variants have appeared since the plasma collection period. Some recent publications question the effectiveness of transfusion.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,OTHER,,,,,,,2021,0.0
NCT02358031,,2015-02-03,2020-01-29,,2024-09-05,2015-02-03,2015-02-06,ESTIMATED,2020-02-03,2020-02-17,ACTUAL,,,,2024-09-05,2024-09-20,ACTUAL,2015-03-19,ACTUAL,2015-03-19,2024-09,2024-09-30,2023-07-19,ACTUAL,2023-07-19,2019-02-25,ACTUAL,2019-02-25,,INTERVENTIONAL,,,A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048),A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma,COMPLETED,,PHASE3,882.0,ACTUAL,Merck Sharp & Dohme LLC,,3.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,INDUSTRY,,,,,,,2023,1.0
NCT01381211,,2011-06-14,,,2022-12-13,2011-06-22,2011-06-27,ESTIMATED,,,,,,,2022-12-13,2022-12-15,ACTUAL,2011-09,ACTUAL,2011-09-30,2019-09,2019-09-30,2020-03,ACTUAL,2020-03-31,2018-03,ACTUAL,2018-03-31,,INTERVENTIONAL,TRACE,,Transarterial RAdioembolization Versus ChemoEmbolization for the Treatment of Hepatocellular Carcinoma (HCC),Transarterial RAdioembolization Versus ChemoEmbolization for the Treatment of HCC: A Multicenter Randomized Controlled Trial (TRACE Trial),TERMINATED,,PHASE2,72.0,ACTUAL,"University Hospital, Ghent",,2.0,,based on interim analysis results,f,,,,f,,,,,,,,,,,,,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,OTHER,,,,,,,2020,0.0
NCT04584034,,2020-09-03,,,2021-07-16,2020-10-08,2020-10-12,ACTUAL,,,,,,,2021-07-16,2021-07-23,ACTUAL,2021-09,ESTIMATED,2021-09-30,2021-07,2021-07-31,2023-04,ESTIMATED,2023-04-30,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,KIWI,,"Bronchodilators for Wheeze in Young Children Presenting to Primary Care: a Randomised, Placebo-controlled, Multicentre, Parallel Group Trial","Bronchodilators for Wheeze in Young Children Presenting to Primary Care: a Randomised, Placebo-controlled, Multicentre, Parallel Group Trial",WITHDRAWN,,PHASE4,0.0,ACTUAL,UMC Utrecht,,2.0,,Premature ending of the study due to impossibility of obtaining a suitable placebo-inhaler,f,,,,f,t,f,,,t,,,Data will only be accessable after publication of trial results. Data will be stored for at least 25 years.,"On request, after approval of principle investigator.",,YES,"We will make our data accessable for verification and future research (other researchers / spin-off projects), yet these will be shared under restrictions. Data cannot be reused without consulting the research team.",2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,OTHER,,,,,,,2023,0.0
NCT03904251,,2019-04-03,,,2023-11-17,2019-04-03,2019-04-05,ACTUAL,,,,,,,2023-11-17,2023-11-18,ACTUAL,2019-07-18,ACTUAL,2019-07-18,2023-11,2023-11-30,2023-10-25,ACTUAL,2023-10-25,2023-10-25,ACTUAL,2023-10-25,,INTERVENTIONAL,,,CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia,A Phase Ib Trial With Dose Expansion Evaluating CPX-351 Plus Gemtuzumab Ozogamicin for Relapsed Acute Myelogenous Leukemia,TERMINATED,,PHASE1,13.0,ACTUAL,Jonsson Comprehensive Cancer Center,,1.0,,slow accrual,,,,,t,t,f,,,t,,,,,,,,2024-10-16 21:24:29.407204,2024-10-16 21:24:29.407204,OTHER,,,,,,,2023,0.0
NCT02673398,,2016-01-21,2021-07-29,,2023-06-14,2016-02-01,2016-02-03,ESTIMATED,2022-03-14,2022-03-16,ACTUAL,,,,2023-06-14,2023-06-18,ACTUAL,2016-12-02,ACTUAL,2016-12-02,2023-06,2023-06-30,2022-09-22,ACTUAL,2022-09-22,2020-03-12,ACTUAL,2020-03-12,,INTERVENTIONAL,,,Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer,Phase II Study of Neratinib in Patients 60 and Older With HER2 Positive Metastatic Breast Cancer,COMPLETED,,PHASE2,25.0,ACTUAL,City of Hope Medical Center,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,OTHER,,,,,,,2022,1.0
NCT05211284,,2022-01-24,,2024-10-01,2024-09-18,2022-01-24,2022-01-27,ACTUAL,,,,,,,2024-09-18,2024-09-23,ACTUAL,2022-12-08,ACTUAL,2022-12-08,2024-09,2024-09-30,2023-10-02,ACTUAL,2023-10-02,2023-10-02,ACTUAL,2023-10-02,,INTERVENTIONAL,SARONAPLUS,,Saroglitazar Magnesium 4 mg for NAFLD in People Living With HIV in the US,"A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Saroglitazar Magnesium for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With Human Immunodeficiency Virus (HIV) in the US",TERMINATED,,PHASE2,4.0,ACTUAL,Zydus Therapeutics Inc.,,2.0,,Sponsor Decision,,,,,t,t,f,,,,,,,,,,,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,INDUSTRY,,,,,,,2023,0.0
NCT02994953,,2016-12-14,2023-10-31,,2024-05-13,2016-12-14,2016-12-16,ESTIMATED,2024-05-13,2024-09-20,ACTUAL,,,,2024-05-13,2024-09-20,ACTUAL,2017-01-31,ACTUAL,2017-01-31,2024-05,2024-05-31,2020-10-08,ACTUAL,2020-10-08,2020-10-08,ACTUAL,2020-10-08,,INTERVENTIONAL,COMBO,,"A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12)","A Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination With M9241(NHS-IL12) in Subjects With Locally Advanced, Unresectable, or Metastatic Solid Tumors",TERMINATED,,PHASE1,52.0,ACTUAL,EMD Serono,The study was terminated due to pre-specified futility criteria met.,6.0,,The study was terminated due to pre-specified futility criteria met.,f,,,,f,t,f,,,,,,,,,NO,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21",2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,INDUSTRY,,,,,,,2020,0.0
NCT03549871,,2018-05-25,2023-01-10,,2023-01-10,2018-06-06,2018-06-08,ACTUAL,2023-01-10,2023-02-06,ACTUAL,,,,2023-01-10,2023-02-06,ACTUAL,2018-07-25,ACTUAL,2018-07-25,2023-01,2023-01-31,2022-03-25,ACTUAL,2022-03-25,2022-01-20,ACTUAL,2022-01-20,,INTERVENTIONAL,ATLAS-PPX,Baseline analysis population included all completed participants from BPA/factor prophylaxis period + 2 participants from Cohort A subgroup who directly enrolled to fitusiran treatment period.,A Study of Fitusiran in Severe Hemophilia A and B Patients Previously Receiving Factor or Bypassing Agent Prophylaxis,"ATLAS-PPX: an Open-label, Multinational, Switching Study to Describe the Efficacy and Safety of Fitusiran Prophylaxis in Patients With Hemophilia A and B Previously Receiving Factor or Bypassing Agent Prophylaxis.",COMPLETED,,PHASE3,80.0,ACTUAL,Sanofi,,1.0,,,f,,,,t,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,INDUSTRY,,,,,,,2022,1.0
NCT03927573,,2019-04-16,,,2023-07-07,2019-04-24,2019-04-25,ACTUAL,,,,,,,2023-07-07,2023-07-10,ACTUAL,2019-04-15,ACTUAL,2019-04-15,2023-07,2023-07-31,2023-06-28,ACTUAL,2023-06-28,2023-06-28,ACTUAL,2023-06-28,,INTERVENTIONAL,,,"Study With Bispecific Antibody Engaging T-cells, in Patients With Progressive Cancer Diseases With Positive PSCA Marker","A Multicenter, Open-label, Dose-escalating, Phase I Trial With GEM3PSCA, a PSCA Targeted Bispecific Antibody Engaging T-cells, in Patients With Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSCA Marker",TERMINATED,,PHASE1,23.0,ACTUAL,AvenCell Europe GmbH,,1.0,,business decision by sponsor,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,INDUSTRY,,,,,,,2023,0.0
NCT03313180,,2017-10-13,2024-01-24,,2024-01-24,2017-10-17,2017-10-18,ACTUAL,2024-01-24,2024-02-20,ACTUAL,,,,2024-01-24,2024-02-20,ACTUAL,2017-11-27,ACTUAL,2017-11-27,2024-01,2024-01-31,2023-01-25,ACTUAL,2023-01-25,2023-01-25,ACTUAL,2023-01-25,,INTERVENTIONAL,,Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication,A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis,An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD),COMPLETED,,PHASE3,444.0,ACTUAL,Boehringer Ingelheim,,1.0,,,t,,,,f,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,INDUSTRY,,NCT03843892,APPROVED_FOR_MARKETING,,,,2023,1.0
NCT04050852,,2019-08-07,,,2021-06-25,2019-08-07,2019-08-08,ACTUAL,,,,,,,2021-06-25,2021-06-29,ACTUAL,2019-07-17,ACTUAL,2019-07-17,2021-06,2021-06-30,2021-04-01,ACTUAL,2021-04-01,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,,,Pulmonary Function Test Changes and Respiratory Muscle Strength Trends in Spinal Muscular Atrophy Patients Receiving Nusinersen Treatments,Pulmonary Function Test Changes and Respiratory Muscle Strength Trends in Spinal Muscular Atrophy Patients Receiving Nusinersen Treatments,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,NYU Langone Health,,1.0,,no enrolled prospects,f,,,,f,t,f,,,,,,,,,,,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,OTHER,,,,,,,2021,0.0
NCT03144661,,2017-05-05,,,2020-07-13,2017-05-05,2017-05-09,ACTUAL,,,,,,,2020-07-13,2020-07-15,ACTUAL,2017-05-25,ACTUAL,2017-05-25,2020-07,2020-07-31,2020-06-10,ACTUAL,2020-06-10,2020-06-10,ACTUAL,2020-06-10,,INTERVENTIONAL,,,An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies,"A Phase 1, Open-Label, Dose-Escalation and Expansion, Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies",TERMINATED,,PHASE1,25.0,ACTUAL,Incyte Corporation,,4.0,,Strategic Business Decision,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,INDUSTRY,,,,,,,2020,0.0
NCT03858972,,2019-02-26,,,2021-07-26,2019-02-28,2019-03-01,ACTUAL,,,,,,,2021-07-26,2021-07-30,ACTUAL,2019-02-05,ACTUAL,2019-02-05,2021-07,2021-07-31,2021-06-11,ACTUAL,2021-06-11,2021-06-11,ACTUAL,2021-06-11,,INTERVENTIONAL,CONTESSA 2,,"Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC","Multinational, Multicenter, Phase 2 Study of Tesetaxel Plus a Reduced Dose of Capecitabine in Patients With HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane",TERMINATED,,PHASE2,152.0,ACTUAL,"Odonate Therapeutics, Inc.",,1.0,,The Sponsor has discontinued the development of tesetaxel,f,,,,f,t,f,,,,,,,,,,,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,INDUSTRY,,,,,,,2021,0.0
NCT03275597,,2017-09-05,,,2023-05-11,2017-09-05,2017-09-07,ACTUAL,,,,,,,2023-05-11,2023-05-15,ACTUAL,2018-02-20,ACTUAL,2018-02-20,2023-05,2023-05-31,2020-07-01,ACTUAL,2020-07-01,2020-07-01,ACTUAL,2020-07-01,,INTERVENTIONAL,,,Phase Ib Study of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Non-small Lung Cancer (NSCLC) With Dual Immune Checkpoint Inhibition,Comprehensive Stereotactic Body Radiotherapy (SBRT) to All Sites of Oligometastatic Non-small Cell Lung Cancer (NSCLC) Combined With Durvalumab (MEDI4736) and Tremelimumab Dual Immune Checkpoint Inhibition.,TERMINATED,,PHASE1,17.0,ACTUAL,"University of Wisconsin, Madison",,1.0,,slow accrual,f,,,,,t,f,,,,,,,,,,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,OTHER,,,,,,,2020,0.0
NCT03395405,,2018-01-04,2022-08-18,,2023-09-28,2018-01-04,2018-01-10,ACTUAL,2022-09-26,2022-10-24,ACTUAL,,,,2023-09-28,2023-10-11,ACTUAL,2018-10-15,ACTUAL,2018-10-15,2021-06-25,2021-06-25,2021-08-24,ACTUAL,2021-08-24,2021-08-24,ACTUAL,2021-08-24,,INTERVENTIONAL,,,NNITS-Nitazoxanide for Norovirus in Transplant Patients Study,"A Phase 2 Multi-Center, Prospective, Randomized, Double-Blind Study to Assess the Clinical and Antiviral Efficacy and Safety of Nitazoxanide for the Treatment of Norovirus in Hematopoietic Stem Cell and Solid Organ Transplant Recipients",COMPLETED,,PHASE2,31.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,NIH,,,,,,,2021,1.0
NCT04189952,,2019-12-04,2022-08-23,,2022-08-23,2019-12-04,2019-12-06,ACTUAL,2022-08-23,2022-09-19,ACTUAL,,,,2022-08-23,2022-09-19,ACTUAL,2020-09-22,ACTUAL,2020-09-22,2022-08,2022-08-31,2022-03-01,ACTUAL,2022-03-01,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,,,Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma,"A Phase 2, Open-Label Study of Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Non-Germinal Center Diffuse Large B Cell Lymphoma, Transformed Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia or Transformed Marginal Zone Lymphoma",TERMINATED,,PHASE2,2.0,ACTUAL,University of Miami,"To protect participant privacy and maintain confidentiality, results will not be reported.",1.0,,Investigator Decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:22:30.048582,2024-10-16 00:22:30.048582,OTHER,,,,,,,2022,0.0
NCT02460692,,2015-05-29,2023-06-16,,2023-09-02,2015-06-01,2015-06-02,ESTIMATED,2023-09-02,2023-09-28,ACTUAL,,,,2023-09-02,2023-09-28,ACTUAL,2016-12,ACTUAL,2016-12-31,2023-09,2023-09-30,2020-03-25,ACTUAL,2020-03-25,2020-03-25,ACTUAL,2020-03-25,,INTERVENTIONAL,,,Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain,A Randomized Controlled Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain,COMPLETED,,PHASE2,131.0,ACTUAL,"University of California, San Diego",,3.0,,,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,OTHER,,,,,,,2020,1.0
NCT03006770,,2016-12-27,,,2024-08-29,2016-12-27,2016-12-30,ESTIMATED,,,,,,,2024-08-29,2024-08-30,ACTUAL,2017-05-22,ACTUAL,2017-05-22,2024-08,2024-08-31,2022-04-20,ACTUAL,2022-04-20,2021-03-03,ACTUAL,2021-03-03,,INTERVENTIONAL,,,"Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization","Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization",COMPLETED,,PHASE3,213.0,ACTUAL,Pluristem Ltd.,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,INDUSTRY,,,,,,,2022,1.0
NCT04072601,,2019-06-05,,,2023-01-11,2019-08-27,2019-08-28,ACTUAL,,,,,,,2023-01-11,2023-01-13,ACTUAL,2019-11-08,ACTUAL,2019-11-08,2023-01,2023-01-31,2023-01-10,ACTUAL,2023-01-10,2022-07-31,ACTUAL,2022-07-31,,INTERVENTIONAL,STATLiver,,Statins for Prevention of Disease Progression and Hospitalization in Liver Cirrhosis,"Statins for Prevention of Disease Progression and Hospitalization in Liver Cirrhosis: A Multi-center, Randomized, Double Blind, Placebo-controlled Trial. The STATLiver Trial",TERMINATED,,PHASE4,78.0,ACTUAL,"Copenhagen University Hospital, Hvidovre",,2.0,,Study part one completed,f,,,,t,f,f,,,,,,"Data will be stored for up to 10 years after completion of the trial, depending on approval from Danish Health Authorities, Scientific Ethics Comittee and the Danish Data Protection Regulation.",upon request,,YES,"IPD and supporting information are planned to be shared via data repository sites, such as UCPH data repository or other public data repository.",2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,OTHER,,,,,,,2023,0.0
NCT03870880,,2019-02-26,2022-01-28,2020-11-26,2022-02-24,2019-03-08,2019-03-12,ACTUAL,2022-01-28,2022-02-23,ACTUAL,2020-11-26,2020-11-30,ACTUAL,2022-02-24,2022-03-25,ACTUAL,2017-08-25,ACTUAL,2017-08-25,2019-03,2019-03-31,2020-01-08,ACTUAL,2020-01-08,2020-01-08,ACTUAL,2020-01-08,,INTERVENTIONAL,PRISMA-3_OLE,All analyses were undertaken on the population of patients who received at least one dose of study drug during the OLE study.,Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension,"Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Injections of Risperidone ISM® in Patients With Acute Exacerbation of Schizophrenia: Open Label Extension (PRISMA-3_OLE)",COMPLETED,,PHASE3,215.0,ACTUAL,Rovi Pharmaceuticals Laboratories,,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,INDUSTRY,,,,,,,2020,1.0
NCT03950414,,2019-04-15,,,2024-02-15,2019-05-10,2019-05-15,ACTUAL,,,,,,,2024-02-15,2024-02-20,ACTUAL,2019-09-27,ACTUAL,2019-09-27,2024-02,2024-02-29,2022-07-11,ACTUAL,2022-07-11,2022-07-11,ACTUAL,2022-07-11,,INTERVENTIONAL,,,A Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients,A Phase I Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients,TERMINATED,,PHASE1,2.0,ACTUAL,"University of Wisconsin, Madison",,1.0,,Insufficient Patient Population,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,OTHER,,,,,,,2022,0.0
NCT04108468,,2019-09-26,,,2024-01-09,2019-09-27,2019-09-30,ACTUAL,,,,,,,2024-01-09,2024-01-10,ACTUAL,2015-10-27,ACTUAL,2015-10-27,2024-01,2024-01-31,2023-07,ACTUAL,2023-07-31,2023-07,ACTUAL,2023-07-31,,INTERVENTIONAL,GOLMePsA,,GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA (GOLMEPsA),"An Investigator-initiated Double-blind, Parallel-group Randomised Controlled Trial of GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA Using Clinical and Whole Body MRI Outcomes: the GOLMePsA Study.",COMPLETED,,PHASE3,84.0,ACTUAL,The Leeds Teaching Hospitals NHS Trust,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,OTHER,,,,,,,2023,0.0
NCT03926117,,2019-04-19,2023-06-25,2021-05-31,2023-08-08,2019-04-19,2019-04-24,ACTUAL,2023-08-08,2023-08-09,ACTUAL,,2023-08-09,ACTUAL,2023-08-08,2023-08-09,ACTUAL,2019-06-03,ACTUAL,2019-06-03,2023-08,2023-08-31,2020-06-26,ACTUAL,2020-06-26,2020-06-26,ACTUAL,2020-06-26,,INTERVENTIONAL,RESCUE,Intent-to-treat (ITT) analysis population included all randomized participants.,Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition,"A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition",COMPLETED,,PHASE2,264.0,ACTUAL,Novo Nordisk A/S,,4.0,,,,,,,t,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,INDUSTRY,,,,,,,2020,1.0
NCT03222973,,2017-07-17,2022-02-10,,2022-04-01,2017-07-17,2017-07-19,ACTUAL,2022-04-01,2022-04-28,ACTUAL,,,,2022-04-01,2022-04-28,ACTUAL,2017-11-15,ACTUAL,2017-11-15,2022-03,2022-03-31,2021-02-12,ACTUAL,2021-02-12,2021-02-12,ACTUAL,2021-02-12,,INTERVENTIONAL,AFFINITY,Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to their treatment assignment regardless of actual treatment received.,Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS),"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies",TERMINATED,,PHASE2,263.0,ACTUAL,Biogen,The top-line results from the Part 1 did not meet the pre-specified primary endpoint nor the key secondary endpoints. The decision to discontinue study 215MS202 Part 2 was not based on safety concerns.,2.0,,The top-line results from the Part 1 did not meet the pre-specified primary endpoint nor the key secondary endpoints. The decision to discontinue study 215MS202 Part 2 was not based on safety concerns.,f,,,,t,t,f,,,,,,,,,,,2024-10-14 23:59:37.480946,2024-10-14 23:59:37.480946,INDUSTRY,,,,,,,2021,0.0
NCT04504331,,2020-08-05,2023-04-04,2022-10-21,2023-05-30,2020-08-05,2020-08-07,ACTUAL,2023-05-30,2023-06-01,ACTUAL,2022-10-21,2022-10-25,ACTUAL,2023-05-30,2023-06-01,ACTUAL,2020-10-13,ACTUAL,2020-10-13,2023-05,2023-05-31,2021-10-22,ACTUAL,2021-10-22,2021-10-22,ACTUAL,2021-10-22,,INTERVENTIONAL,,,"Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer","A Phase 1B Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer",TERMINATED,,PHASE1,4.0,ACTUAL,Stanford University,,3.0,,Drug manufacturer decision to terminate development.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,OTHER,,,,,,,2021,0.0
NCT00114140,,2005-06-13,2017-01-17,,2024-07-03,2005-06-13,2005-06-14,ESTIMATED,2017-10-02,2017-11-06,ACTUAL,,,,2024-07-03,2024-07-08,ACTUAL,2005-01,,2005-01-31,2022-05,2022-05-31,2022-05-20,ACTUAL,2022-05-20,2013-02,ACTUAL,2013-02-28,,INTERVENTIONAL,,Eligible patients,Temozolomide and Radiation Therapy in Treating Patients With Gliomas,A Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High-Risk Low-Grade Gliomas,COMPLETED,,PHASE2,136.0,ACTUAL,Radiation Therapy Oncology Group,Quality of life endpoint was added via an amendment while study was in progress.,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,NETWORK,,,,,,,2022,1.0
NCT03992131,,2019-06-04,2023-12-04,,2024-01-12,2019-06-18,2019-06-20,ACTUAL,2024-01-12,2024-01-16,ACTUAL,,,,2024-01-12,2024-01-16,ACTUAL,2019-06-28,ACTUAL,2019-06-28,2024-01,2024-01-31,2022-04-22,ACTUAL,2022-04-22,2022-03-08,ACTUAL,2022-03-08,,INTERVENTIONAL,,Safety population included all participants who have received at least 1 dose of study drug.,A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR),"SEASTAR: A Phase 1b/2, Open-label, Parallel Arm Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor",TERMINATED,,PHASE1/PHASE2,25.0,ACTUAL,pharmaand GmbH,The study was terminated due to Sponsor's decision to discontinue development of the combination of rucaparib and sacituzumab govitecan.,3.0,,"Due to a change in development priorities, no further clinical development of the lucitanib plus rucaparib or lucitanib plus sacituzumab govitecan combinations is planned at this time.",f,,,,t,t,f,,,,,,,,,,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,,,,,,2022,0.0
NCT04725240,,2021-01-06,2023-06-21,,2023-08-30,2021-01-22,2021-01-26,ACTUAL,2023-08-30,2023-09-21,ACTUAL,,,,2023-08-30,2023-09-21,ACTUAL,2021-06-07,ACTUAL,2021-06-07,2023-08,2023-08-31,2022-06-28,ACTUAL,2022-06-28,2022-06-28,ACTUAL,2022-06-28,,INTERVENTIONAL,,The Full Analysis Set included all participants who received at least 1 dose of setmelanotide and had baseline data.,Open-Label Study of Setmelanotide in Hypothalamic Obesity,"A Phase 2, Open-Label 20-Week Study to Evaluate the Safety and Efficacy of Setmelanotide in Subjects With Hypothalamic Obesity",COMPLETED,,PHASE2,18.0,ACTUAL,"Rhythm Pharmaceuticals, Inc.",,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,,,,,,2022,1.0
NCT03984370,,2019-06-06,,,2020-03-28,2019-06-11,2019-06-13,ACTUAL,,,,,,,2020-03-28,2020-03-31,ACTUAL,2019-09-18,ACTUAL,2019-09-18,2020-03,2020-03-31,2020-02-26,ACTUAL,2020-02-26,2020-02-26,ACTUAL,2020-02-26,,INTERVENTIONAL,,,Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass,Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass,COMPLETED,,PHASE2,10.0,ACTUAL,"University Hospital, Gentofte, Copenhagen",,3.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,OTHER,,,,,,,2020,1.0
NCT04165031,,2019-11-14,2021-10-27,,2021-10-27,2019-11-14,2019-11-15,ACTUAL,2021-10-27,2021-11-24,ACTUAL,,,,2021-10-27,2021-11-24,ACTUAL,2019-11-28,ACTUAL,2019-11-28,2021-10,2021-10-31,2020-10-30,ACTUAL,2020-10-30,2020-10-30,ACTUAL,2020-10-30,,INTERVENTIONAL,,All participants who received at least one dose of study drug,A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation,A Phase 1/2 Study of LY3499446 Administered to Patients With Advanced Solid Tumors With KRAS G12C Mutation,TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,Eli Lilly and Company,The study was terminated due to an unexpected toxicity finding.,6.0,,The study was terminated due to an unexpected toxicity finding.,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,,,,,,2020,0.0
NCT03603080,,2018-07-18,,,2023-02-13,2018-07-24,2018-07-27,ACTUAL,,,,,,,2023-02-13,2023-02-14,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2023-02,2023-02-28,2022-09-01,ACTUAL,2022-09-01,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,,,Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy,A Prospective Randomized Study Evaluating the Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy,TERMINATED,,PHASE4,12.0,ACTUAL,Hartford Hospital,,2.0,,Difficulty with enrollment and then Covid pandemic,f,,,,,t,f,,,t,,,,,,NO,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,OTHER,,,,,,,2022,0.0
NCT04387240,,2020-05-12,,,2022-04-26,2020-05-12,2020-05-13,ACTUAL,,,,,,,2022-04-26,2022-05-02,ACTUAL,2022-01,ESTIMATED,2022-01-31,2022-04,2022-04-30,2022-12,ESTIMATED,2022-12-31,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19,Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19,WITHDRAWN,,PHASE2,0.0,ACTUAL,Princess Nourah Bint Abdulrahman University,,2.0,,did not get enough fund and IRB request,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,OTHER,,,,,,,2022,0.0
NCT04358458,,2020-04-01,2024-05-16,2023-09-12,2024-08-09,2020-04-20,2020-04-24,ACTUAL,2024-08-09,2024-08-13,ACTUAL,,2024-08-13,ACTUAL,2024-08-09,2024-08-13,ACTUAL,2020-03-13,ACTUAL,2020-03-13,2024-08,2024-08-31,2023-07-28,ACTUAL,2023-07-28,2022-11-21,ACTUAL,2022-11-21,,INTERVENTIONAL,,The Full analysis set (FAS) comprises all participants to whom study drug had been assigned and who had received at least 1 dose of GEN3009.,First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas,"Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A First-in-Human, Open-label, Phase 1/2a Dose Escalation Trial With Dose Expansion Cohorts",TERMINATED,,PHASE1/PHASE2,46.0,ACTUAL,Genmab,"The trial was terminated due to strategic evaluation of GEN3009 within context of Genmab's portfolio, decision not based on any safety or regulatory concerns.",2.0,,"Due to strategic evaluation of GEN3009 within context of Genmab's portfolio, decision not based on any safety or regulatory concerns.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,INDUSTRY,,,,,,,2023,0.0
NCT05370040,,2022-05-09,2024-04-09,,2024-04-09,2022-05-09,2022-05-11,ACTUAL,2024-04-09,2024-05-01,ACTUAL,,,,2024-04-09,2024-05-01,ACTUAL,2022-05-05,ACTUAL,2022-05-05,2024-04,2024-04-30,2024-03-11,ACTUAL,2024-03-11,2024-03-11,ACTUAL,2024-03-11,,INTERVENTIONAL,,,THEMBA II T-Cell Vaccine: Vaccination With saRNA COVID-19 Vaccines,"THEMBA II T-CELL Vaccine: A Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of Vaccination With saRNA COVID-19 Vaccines",TERMINATED,,PHASE1/PHASE2,60.0,ACTUAL,"ImmunityBio, Inc.",The study was terminated early. Only the safety data is provided.~Only one adverse event table per AE category was presented to reduce data entry redundancy.,10.0,,Discontinued prior to enroll in Phase 2,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,INDUSTRY,,,,,,,2024,0.0
NCT04638634,,2020-11-19,,,2021-12-09,2020-11-19,2020-11-20,ACTUAL,,,,,,,2021-12-09,2021-12-10,ACTUAL,2021-02-02,ACTUAL,2021-02-02,2021-12,2021-12-31,2021-06-09,ACTUAL,2021-06-09,2021-06-09,ACTUAL,2021-06-09,,INTERVENTIONAL,,,"Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects","A Single Center, Phase 1, Single-Ascending Dose, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects",TERMINATED,,PHASE1,12.0,ACTUAL,CSL Behring,,2.0,,"For business reasons, not a safety issue",f,,,,f,f,f,,,,,,IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.,Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.~An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.~The requesting party must execute an appropriate data sharing agreement before IPD will be made available.,,YES,"CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.~Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.~If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.",2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,,,,,,2021,0.0
NCT03319537,,2017-10-20,2024-04-30,,2024-04-30,2017-10-20,2017-10-24,ACTUAL,2024-04-30,2024-05-23,ACTUAL,,,,2024-04-30,2024-05-23,ACTUAL,2017-10-05,ACTUAL,2017-10-05,2024-04,2024-04-30,2023-06-05,ACTUAL,2023-06-05,2023-06-05,ACTUAL,2023-06-05,,INTERVENTIONAL,,No participants accrued to pevonedistat in combination with pemetrexed and cisplatin cohort,Pevonedistat Alone and in Combination With Chemotherapy in Patients With Mesothelioma,Pevonedistat as a Single Agent and in Combination With Chemotherapy in Patients With Malignant Mesothelioma,TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,2.0,,Sponsor terminated study agreement,f,,,,,t,f,,,,,,,,,,,2024-10-15 14:13:07.075647,2024-10-15 14:13:07.075647,OTHER,,,,,,,2023,0.0
NCT06009237,,2023-08-21,,,2023-11-09,2023-08-21,2023-08-24,ACTUAL,,,,,,,2023-11-09,2023-11-13,ACTUAL,2023-08-23,ACTUAL,2023-08-23,2023-11,2023-11-30,2023-10-30,ACTUAL,2023-10-30,2023-10-30,ACTUAL,2023-10-30,,INTERVENTIONAL,,,"A Study to Assess Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Participants","A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Subjects",TERMINATED,,PHASE1,24.0,ACTUAL,AbbVie,,5.0,,Strategic considerations,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,INDUSTRY,,,,,,,2023,0.0
NCT03534284,,2018-05-01,2024-01-08,,2024-02-02,2018-05-11,2018-05-23,ACTUAL,2024-02-02,2024-02-05,ACTUAL,,,,2024-02-02,2024-02-05,ACTUAL,2018-09-19,ACTUAL,2018-09-19,2024-02,2024-02-29,2022-11-17,ACTUAL,2022-11-17,2022-10-17,ACTUAL,2022-10-17,,INTERVENTIONAL,Sleep-HD,,Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis,Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis (Sleep-HD),COMPLETED,,PHASE3,126.0,ACTUAL,University of Washington,,3.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,OTHER,,,,,,,2022,1.0
NCT04852367,,2021-04-07,,,2023-04-11,2021-04-15,2021-04-21,ACTUAL,,,,,,,2023-04-11,2023-04-12,ACTUAL,2021-06-16,ACTUAL,2021-06-16,2023-03,2023-03-31,2023-03-30,ACTUAL,2023-03-30,2023-03-30,ACTUAL,2023-03-30,,INTERVENTIONAL,PanDox,,PanDox: Targeted Doxorubicin in Pancreatic Tumours,PanDox: Feasibility of Enhanced Chemotherapy Delivery to Non-resectable Primary Pancreatic Tumours Using Thermosensitive Liposomal Doxorubicin (ThermoDox®) and Focused Ultrasound,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Oxford,,2.0,,Lack of recruitment,f,,,,f,f,f,,,,,,,,,NO,Plan to anonymise patient data (assigned trial number) and results to be published in peer reviewed journal as anonymous data points/averaged data,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,OTHER,,,,,,,2023,0.0
NCT04533737,,2020-08-26,2023-09-07,,2024-07-23,2020-08-26,2020-09-01,ACTUAL,2024-01-08,2024-01-09,ACTUAL,,,,2024-07-23,2024-08-13,ACTUAL,2020-12-17,ACTUAL,2020-12-17,2024-02,2024-02-29,2022-12-07,ACTUAL,2022-12-07,2022-09-08,ACTUAL,2022-09-08,,INTERVENTIONAL,COBRA,ITT: All randomized subjects,Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab,Efficacy and Safety Comparison of Brodalumab Versus Guselkumab in Adult Subjects With Moderate-to-severe Plaque Psoriasis and Inadequate Response to Ustekinumab,TERMINATED,,PHASE4,113.0,ACTUAL,LEO Pharma,,2.0,,The recruitment was terminated early due to delays and slow recruitment that significantly jeopardized the trial timelines. There were no safety concerns related to the early termination of the trial.,f,,,,f,t,f,,,t,,,,De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.,http://leopharmatrials.com/for-researchers,YES,,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,INDUSTRY,,,,,,,2022,0.0
NCT04857931,,2021-03-29,,,2023-04-24,2021-04-20,2021-04-23,ACTUAL,,,,,,,2023-04-24,2023-04-26,ACTUAL,2022-06-17,ACTUAL,2022-06-17,2023-04,2023-04-30,2023-03-07,ACTUAL,2023-03-07,2023-03-07,ACTUAL,2023-03-07,,INTERVENTIONAL,COLpEF,,Colchicine in HFpEF,A Biomarker Study Assessing the Effects of Colchicine on Inflammation and Extra-Cellular Matrix Turnover in Patients With Heart Failure and Preserved Ejection Fraction.,TERMINATED,,PHASE2,14.0,ACTUAL,Montreal Heart Institute,,3.0,,"Lack of funds to support opening of new sites to help patient recruitment, which was found to be more challenging than initially expected.",f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 14:13:07.075647,2024-10-15 14:13:07.075647,OTHER,,,,,,,2023,0.0
NCT01824823,,2013-04-02,2015-12-22,,2023-06-13,2013-04-02,2013-04-05,ESTIMATED,2016-03-04,2016-04-04,ESTIMATED,,,,2023-06-13,2023-06-28,ACTUAL,2014-06-30,ACTUAL,2014-06-30,2023-06,2023-06-30,2020-12,ACTUAL,2020-12-31,2015-12-13,ACTUAL,2015-12-13,,INTERVENTIONAL,,All randomized patients,Afatinib After Chemoradiation and Surgery in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck at High-Risk of Recurrence,A Randomized Placebo Controlled Phase II Trial of Afatinib (BIBW2992) as Adjuvant Therapy Following Chemoradiation in Patients With Head and Neck Squamous Cell Carcinoma at High Risk of Recurrence,TERMINATED,,PHASE2,3.0,ACTUAL,Eastern Cooperative Oncology Group,"Due to the small sample size, estimates on median DFS and 95% confidence intervals could be unreliable.",2.0,,Slow accrual,f,,,,t,,,,,,,,,,,YES,Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.,2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,NETWORK,,,,,,,2020,0.0
NCT03103490,,2017-03-10,2023-03-15,,2023-03-15,2017-03-31,2017-04-06,ACTUAL,2023-03-15,2023-04-07,ACTUAL,,,,2023-03-15,2023-04-07,ACTUAL,2017-08-02,ACTUAL,2017-08-02,2023-03,2023-03-31,2021-09-28,ACTUAL,2021-09-28,2021-09-28,ACTUAL,2021-09-28,,INTERVENTIONAL,,,18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation,18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation,TERMINATED,,PHASE2,45.0,ACTUAL,Stanford University,,1.0,,Loss of funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,OTHER,,,,,,,2021,0.0
NCT04157751,,2019-11-04,2022-05-10,,2022-06-28,2019-11-06,2019-11-08,ACTUAL,2022-05-10,2022-06-06,ACTUAL,,,,2022-06-28,2022-07-19,ACTUAL,2020-05-18,ACTUAL,2020-05-18,2022-06,2022-06-30,2021-06-02,ACTUAL,2021-06-02,2021-05-28,ACTUAL,2021-05-28,,INTERVENTIONAL,,"Randomised Set (RS), including all randomised patients.",A Study to Test the Effect of Empagliflozin in Patients Who Are in Hospital for Acute Heart Failure,"A Multicentre, Randomised, Double-blind, 90-day Superiority Trial to Evaluate the Effect on Clinical Benefit, Safety and Tolerability of Once Daily Oral EMPagliflozin 10 mg Compared to Placebo, Initiated in Patients Hospitalised for acUte Heart faiLure (de Novo or Decompensated Chronic HF) Who Have Been StabilisEd (EMPULSE)",COMPLETED,,PHASE3,530.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,INDUSTRY,,,,,,,2021,1.0
NCT04602078,,2020-10-06,,,2024-03-20,2020-10-20,2020-10-26,ACTUAL,,,,,,,2024-03-20,2024-03-21,ACTUAL,2020-12-23,ACTUAL,2020-12-23,2023-08,2023-08-31,2024-02-02,ACTUAL,2024-02-02,2024-02-02,ACTUAL,2024-02-02,,INTERVENTIONAL,AUREA,,Study of Atezolizumab Combined With Split-dose Gemcitabine Plus Cisplatin in Urothelial Carcinoma,"Phase II, Multicenter, Non-randomized, Single-arm, Open-label Trial of Atezolizumab in Combination of Split-doses of Gemcitabine Plus Cisplatin in Patients With Locally Advanced or Metastatic Urothelial Carcinoma",COMPLETED,,PHASE2,66.0,ACTUAL,Spanish Oncology Genito-Urinary Group,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,OTHER,,,,,,,2024,1.0
NCT04007406,,2019-07-01,,,2022-06-16,2019-07-02,2019-07-05,ACTUAL,,,,,,,2022-06-16,2022-06-21,ACTUAL,2019-11-21,ACTUAL,2019-11-21,2022-06,2022-06-30,2022-05-02,ACTUAL,2022-05-02,2022-05-02,ACTUAL,2022-05-02,,INTERVENTIONAL,,,DP13 - A Phase II Study in Patients With Primary Aldosteronism,"DP13 - A Phase II Study in Patients With Primary Aldosteronism to Evaluate the Efficacy, Safety and Tolerability of DP13, Over an 8-week Treatment Period",COMPLETED,,PHASE2,36.0,ACTUAL,Damian Pharma AG,,3.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,,,,,,2022,1.0
NCT04495179,,2020-07-23,2022-10-27,,2023-07-21,2020-07-30,2020-07-31,ACTUAL,2023-07-21,2023-08-09,ACTUAL,,,,2023-07-21,2023-08-09,ACTUAL,2020-08-04,ACTUAL,2020-08-04,2023-07,2023-07-31,2022-08-08,ACTUAL,2022-08-08,2021-11-01,ACTUAL,2021-11-01,,INTERVENTIONAL,AARDVARC,Safety analysis set consisted of all patients who received at least one dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.,A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.,"A Phase II, Open-label, Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination With Durvalumab and in Combination With Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC)",COMPLETED,,PHASE2,30.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,INDUSTRY,,,,,,,2022,0.0
NCT02045446,,2014-01-14,2023-02-16,,2023-04-25,2014-01-22,2014-01-24,ESTIMATED,2023-03-15,2023-04-07,ACTUAL,,,,2023-04-25,2023-05-23,ACTUAL,2014-02,ACTUAL,2014-02-28,2023-04,2023-04-30,2022-05-02,ACTUAL,2022-05-02,2022-02-17,ACTUAL,2022-02-17,,INTERVENTIONAL,,,Maintenance Chemotherapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Chemotherapy for Stage IV Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II Trial,Maintenance Chemotherapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Chemotherapy for Stage IV Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II Trial,COMPLETED,,PHASE2,29.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,OTHER,,,,,,,2022,1.0
NCT03194542,,2017-06-15,2023-07-18,,2023-08-22,2017-06-20,2017-06-21,ACTUAL,2023-08-22,2023-08-24,ACTUAL,,,,2023-08-22,2023-08-24,ACTUAL,2017-11-15,ACTUAL,2017-11-15,2023-08,2023-08-31,2022-07-18,ACTUAL,2022-07-18,2022-07-18,ACTUAL,2022-07-18,,INTERVENTIONAL,,,A Safety and Efficacy Study to Evaluate Luspatercept in Subjects With Myeloproliferative Neoplasm-associated Myelofibrosis Who Have Anemia With and Without Red Blood Cell-transfusion Dependence,A Phase-2 Study To Determine Efficacy and Safety of Luspatercept in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis and Anemia With or Without Red Blood Cell-Transfusion Dependence,COMPLETED,,PHASE2,95.0,ACTUAL,Celgene,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,INDUSTRY,,,,,,,2022,1.0
NCT03859427,,2019-01-14,2024-03-25,,2024-08-09,2019-02-27,2019-03-01,ACTUAL,2024-03-25,2024-04-18,ACTUAL,,,,2024-08-09,2024-08-13,ACTUAL,2019-05-08,ACTUAL,2019-05-08,2024-08,2024-08-31,2023-03-31,ACTUAL,2023-03-31,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,ARROW2,,A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma,"A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2)",COMPLETED,,PHASE3,454.0,ACTUAL,Amgen,,2.0,,,f,,,,t,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,INDUSTRY,,,,,,,2023,1.0
NCT03885661,,2019-03-19,2021-07-26,,2021-10-15,2019-03-19,2019-03-21,ACTUAL,2021-10-15,2021-11-11,ACTUAL,,,,2021-10-15,2021-11-11,ACTUAL,2016-01-11,ACTUAL,2016-01-11,2021-10,2021-10-31,2021-06,ACTUAL,2021-06-30,2018-08,ACTUAL,2018-08-31,,INTERVENTIONAL,VALUE,,Vascepa to Accelerate Lipoprotein Uptake and Elimination,"Vascepa to Accelerate Lipoprotein Uptake and Elimination (VALUE): An Open-Label, Mechanistic, Randomized, Controlled, Single-Center Trial of AMR101 in Patients With Dyslipidemia",COMPLETED,,PHASE1,20.0,ACTUAL,University of Pennsylvania,,2.0,,,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,OTHER,,,,,,,2021,1.0
NCT05055258,,2021-09-14,,2023-10-05,2023-10-05,2021-09-14,2021-09-24,ACTUAL,,,,,2023-10-10,ACTUAL,2023-10-05,2023-10-10,ACTUAL,2021-09-27,ACTUAL,2021-09-27,2023-10,2023-10-31,2022-10-27,ACTUAL,2022-10-27,2022-10-27,ACTUAL,2022-10-27,,INTERVENTIONAL,KVD824-201,,A Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatment of HAE Type I or II,"Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of 3 Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II",TERMINATED,,PHASE2,33.0,ACTUAL,"KalVista Pharmaceuticals, Ltd.",,4.0,,Terminated by Sponsor due to adverse events reported,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,INDUSTRY,,,,,,,2022,0.0
NCT04797650,,2021-03-10,2023-06-05,,2023-06-30,2021-03-10,2021-03-15,ACTUAL,2023-06-30,2023-07-03,ACTUAL,,,,2023-06-30,2023-07-03,ACTUAL,2021-06-10,ACTUAL,2021-06-10,2023-06,2023-06-30,2022-06-29,ACTUAL,2022-06-29,2022-06-08,ACTUAL,2022-06-08,,INTERVENTIONAL,THRIVE-AA2,All randomized participants included all participants who were randomized in the study.,Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2),"A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata",COMPLETED,,PHASE3,517.0,ACTUAL,Concert Pharmaceuticals,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,,,,,,2022,1.0
NCT02659800,,2016-01-15,,,2023-10-04,2016-01-15,2016-01-20,ESTIMATED,,,,,,,2023-10-04,2023-10-06,ACTUAL,2018-10-30,ACTUAL,2018-10-30,2023-10,2023-10-31,2023-10-03,ACTUAL,2023-10-03,2022-03-30,ACTUAL,2022-03-30,,INTERVENTIONAL,,,Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas,A Phase I and Pilot Study of the Effect of rhIL-7-hyFc (NT-I7) on CD4 Counts in Patients With High Grade Gliomas and Severe Treatment-related CD4 Lymphopenia After Concurrent Radiation and Temozolomide,TERMINATED,,PHASE1,12.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,5.0,,Terminated \[NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer\],f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,OTHER,,,,,,,2023,0.0
NCT03920293,,2019-04-16,2022-05-03,2022-03-11,2024-04-26,2019-04-16,2019-04-18,ACTUAL,2022-05-03,2022-05-26,ACTUAL,2022-03-11,2022-03-15,ACTUAL,2024-04-26,2024-05-28,ACTUAL,2019-03-12,ACTUAL,2019-03-12,2024-04,2024-04-30,2023-05-25,ACTUAL,2023-05-25,2021-05-11,ACTUAL,2021-05-11,,INTERVENTIONAL,,Full Analysis Set: All randomized participants who received at least 1 dose of study drug.,Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis",COMPLETED,,PHASE3,175.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,INDUSTRY,,,,,,,2023,1.0
NCT03831880,,2018-12-21,2021-08-20,,2021-10-12,2019-02-01,2019-02-06,ACTUAL,2021-10-12,2021-10-14,ACTUAL,,,,2021-10-12,2021-10-14,ACTUAL,2019-02-07,ACTUAL,2019-02-07,2021-10,2021-10-31,2020-08-28,ACTUAL,2020-08-28,2020-08-28,ACTUAL,2020-08-28,,INTERVENTIONAL,,The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received.,Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD,"A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN (REGISTERED)) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY",COMPLETED,,PHASE3,87.0,ACTUAL,Pfizer,,2.0,,,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,INDUSTRY,,,,,,,2020,1.0
NCT04102579,,2019-09-23,2023-09-15,2022-09-29,2023-09-15,2019-09-23,2019-09-25,ACTUAL,2023-09-15,2023-10-11,ACTUAL,2022-09-29,2022-10-05,ACTUAL,2023-09-15,2023-10-11,ACTUAL,2019-11-13,ACTUAL,2019-11-13,2023-09,2023-09-30,2021-10-26,ACTUAL,2021-10-26,2021-10-15,ACTUAL,2021-10-15,,INTERVENTIONAL,KINECT-HD,All participants who received at least 1 dose of study drug.,"Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease",COMPLETED,,PHASE3,128.0,ACTUAL,Neurocrine Biosciences,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,INDUSTRY,,,,,,,2021,1.0
NCT03905330,,2019-04-01,2023-08-01,,2023-12-07,2019-04-04,2019-04-05,ACTUAL,2023-12-07,2023-12-11,ACTUAL,,,,2023-12-07,2023-12-11,ACTUAL,2019-07-09,ACTUAL,2019-07-09,2023-12,2023-12-31,2022-09-01,ACTUAL,2022-09-01,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,MARCH-PFIC,,A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC),MRX-502: Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC) - MARCH-PFIC,COMPLETED,,PHASE3,93.0,ACTUAL,"Mirum Pharmaceuticals, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,INDUSTRY,,,,,,,2022,1.0
NCT03579472,,2018-06-15,,,2022-10-27,2018-06-25,2018-07-06,ACTUAL,,,,,,,2022-10-27,2022-10-31,ACTUAL,2018-05-30,ACTUAL,2018-05-30,2022-10,2022-10-31,2022-09-21,ACTUAL,2022-09-21,2022-09-21,ACTUAL,2022-09-21,,INTERVENTIONAL,,,M7824 and Eribulin Mesylate in Treating Patients With Metastatic Triple Negative Breast Cancer,A Phase Ib Trial of M7824 and Eribulin in Patients With Metastatic Triple Negative Breast Cancer (TNBC),TERMINATED,,PHASE1,38.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Due to the fact that the sponsor decided not to move forward with the development of M7824,,,,,f,t,f,,,,,,,,,,,2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,OTHER,,,,,,,2022,0.0
NCT02663518,,2016-01-19,2023-11-20,,2023-11-20,2016-01-25,2016-01-26,ESTIMATED,2023-11-20,2024-05-10,ACTUAL,,,,2023-11-20,2024-05-10,ACTUAL,2016-01-28,ACTUAL,2016-01-28,2023-11,2023-11-30,2022-11-23,ACTUAL,2022-11-23,2022-11-23,ACTUAL,2022-11-23,,INTERVENTIONAL,,Analysis population included all the participants who received at least one dose of study treatment.,A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors,"A Phase 1a/1b Dose Escalation and Expansion Trial of TTI-621, a Novel Biologic Targeting CD47, in Subjects With Relapsed or Refractory Hematologic Malignancies and Selected Solid Tumors",TERMINATED,,PHASE1,249.0,ACTUAL,Pfizer,,16.0,,Pfizer decided terminating study for administrative reasons on 22Mar2022 (stopping enrollment as of 15Apr2022). The decision wasn't due to safety concerns or requests from regulatory authorities.,f,,,,f,,,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,,,,,,2022,0.0
NCT03762265,,2018-11-29,2022-07-13,,2023-07-21,2018-11-30,2018-12-03,ACTUAL,2022-08-26,2022-09-21,ACTUAL,,,,2023-07-21,2023-08-02,ACTUAL,2019-01-08,ACTUAL,2019-01-08,2023-07,2023-07-31,2021-12-17,ACTUAL,2021-12-17,2021-07-30,ACTUAL,2021-07-30,,INTERVENTIONAL,,Analysis was performed on randomized population.,A Study of PRN1008 in Patients With Pemphigus,"A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor Rilzabrutinib (PRN1008) in Moderate to Severe Pemphigus",TERMINATED,,PHASE3,131.0,ACTUAL,Sanofi,Study was terminated prematurely by the Sponsor.,2.0,,Sponsor decision based on lack of efficacy,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 21:05:46.62035,2024-10-16 21:05:46.62035,INDUSTRY,,,,,,,2021,0.0
NCT02885324,,2016-08-24,2022-07-21,,2022-10-04,2016-08-26,2016-08-31,ESTIMATED,2022-07-21,2022-08-15,ACTUAL,,,,2022-10-04,2022-10-06,ACTUAL,2017-05-18,ACTUAL,2017-05-18,2022-10,2022-10-31,2020-08-25,ACTUAL,2020-08-25,2020-08-25,ACTUAL,2020-08-25,,INTERVENTIONAL,,,Pilot Study of Cabozantinib for Recurrent or Progressive Central Nervous System Tumors in Children,Pilot Study of Cabozantinib for Recurrent or Progressive Central Nervous System Tumors in Children,TERMINATED,,PHASE2,4.0,ACTUAL,Indiana University,Early termination leading to small numbers of subjects analyzed.,1.0,,Failure to meet accrual goals.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,OTHER,,,,,,,2020,0.0
NCT04631016,,2020-10-20,,2024-04-12,2024-04-16,2020-11-10,2020-11-16,ACTUAL,,,,,2023-12-15,ACTUAL,2024-04-16,2024-04-17,ACTUAL,2020-12-14,ACTUAL,2020-12-14,2024-04,2024-04-30,2023-11-13,ACTUAL,2023-11-13,2023-05-30,ACTUAL,2023-05-30,,INTERVENTIONAL,FRONTIER-4,,"A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis","A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of MEDI3506 in Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis (FRONTIER 4)",COMPLETED,,PHASE2,136.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,INDUSTRY,,,,,,,2023,0.0
NCT03610581,,2018-07-26,2021-10-11,,2021-11-23,2018-07-26,2018-08-01,ACTUAL,2021-10-11,2021-11-09,ACTUAL,,,,2021-11-23,2021-11-24,ACTUAL,2018-09-27,ACTUAL,2018-09-27,2021-11,2021-11-30,2020-10-15,ACTUAL,2020-10-15,2020-10-15,ACTUAL,2020-10-15,,INTERVENTIONAL,,Full analysis set (FAS) included all participants with at least one vaccination.,"Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With HPV16 or HPV18 Infection of the Cervix","A Randomized, Double-blind, Placebo-controlled, First-in-Human, Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Otherwise Healthy Women With HPV16 or 18 Infection of the Cervix",TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,Janssen Vaccines & Prevention B.V.,"As the study was terminated prematurely, the Sponsor performed a limited analysis on the available data to meet the requirement for reporting the study.",4.0,,"Low enrolment and increasing COVID restrictions, following an earlier enrolment pause in April made it clear that completion of the study would not be feasible",f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,INDUSTRY,,,,,,,2020,0.0
NCT03996057,,2019-06-17,,,2022-07-06,2019-06-20,2019-06-24,ACTUAL,,,,,,,2022-07-06,2022-07-08,ACTUAL,2018-06-20,ACTUAL,2018-06-20,2022-07,2022-07-31,2022-02-11,ACTUAL,2022-02-11,2022-02-11,ACTUAL,2022-02-11,,INTERVENTIONAL,,,"Methenamine in a Non-antibiotic, Multimodal Approach to UTI Prevention","The Efficacy and Effect of Methenamine Hippurate in a Non-antibiotic, Multimodal Approach to UTI Prevention",WITHDRAWN,,PHASE4,0.0,ACTUAL,Washington University School of Medicine,,2.0,,"Project canceled due to PI leaving institution, staff changes and COVID~Project canceled for other reason , describe: - Due to staff changes and COVID~Project canceled due to PI leaving, staff changes and COVID",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,OTHER,,,,,,,2022,0.0
NCT05062759,,2021-08-23,2023-03-09,,2023-06-20,2021-09-21,2021-09-30,ACTUAL,2023-04-14,2023-04-21,ACTUAL,,,,2023-06-20,2023-06-22,ACTUAL,2021-08-23,ACTUAL,2021-08-23,2023-06,2023-06-30,2022-07-18,ACTUAL,2022-07-18,2022-03-21,ACTUAL,2022-03-21,,INTERVENTIONAL,VECTOR,"All patients randomised and receiving any study intervention were included in the Full analysis set, irrespective of their CSP adherence and continued participation in the study.",Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma,"A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Potential Effect of Tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Adolescent and Young Adult Participants With Moderate to Severe Asthma (VECTOR)",COMPLETED,,PHASE3,70.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:~https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:~https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,,,,,,2022,1.0
NCT02846766,,2016-05-12,,,2018-07-31,2016-07-22,2016-07-27,ESTIMATED,,,,,,,2018-07-31,2018-08-02,ACTUAL,2018-07-01,ESTIMATED,2018-07-01,2018-07,2018-07-31,2021-06-01,ESTIMATED,2021-06-01,2020-06-01,ESTIMATED,2020-06-01,,INTERVENTIONAL,,,Study of Lenvatinib in Patients With Advanced Cancer and Aberrations in FGF/FGFR Signaling,"A Multicenter, Histology-Independent Study of the Fibroblast Growth Factor Receptor (FGFR) Inhibitor Lenvatinib (E7080) in Patients With Advanced Cancer and Aberrations in FGF/FGFR Signaling",WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, San Diego",,1.0,,Unable to execute a contract agreement with the drug manufacturer.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,OTHER,,,,,,,2021,0.0
NCT04102202,,2019-09-15,,,2021-03-22,2019-09-22,2019-09-25,ACTUAL,,,,,,,2021-03-22,2021-03-24,ACTUAL,2020-11-15,ESTIMATED,2020-11-15,2021-03,2021-03-31,2021-03-22,ACTUAL,2021-03-22,2021-03-22,ESTIMATED,2021-03-22,,INTERVENTIONAL,,,BOL-DP-o-05 as an Add-On Treatment of Subjects With Newly Diagnosed Type 1 Diabetes Mellitus,"A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, Safety & Efficacy Trial of BOL-DP-o-05 as an Add-On Treatment for Preservation of Beta-Cell Function in Subjects With Newly-Diagnosed T1DM",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Breath of Life International Pharma Ltd,,2.0,,Due to company strategic decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,INDUSTRY,,,,,,,2021,0.0
NCT04762160,,2021-02-05,2023-07-31,,2024-03-21,2021-02-16,2021-02-21,ACTUAL,2023-11-02,2023-11-21,ACTUAL,,,,2024-03-21,2024-03-25,ACTUAL,2020-12-15,ACTUAL,2020-12-15,2024-03,2024-03-31,2022-03-22,ACTUAL,2022-03-22,2022-03-22,ACTUAL,2022-03-22,,INTERVENTIONAL,,"The Safety population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety evaluation, regardless of enhancer of zeste homolog 2 (EZH2) mutation status (mutant-type \[MT\] or wild-type \[WT\]).","SYMPHONY-2, A Trial to Examine Combination of Tazemetostat With Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma","SYMPHONY-II: A Phase II Open-Label, Multicenter Trial of Oral Tazemetostat in Combination With Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma",TERMINATED,,PHASE2,5.0,ACTUAL,Ipsen,The study was terminated early due to business reasons prior to enrolling the target number of participants needed to achieve target power and was insufficient to produce statistically reliable results and was not due to any safety concerns. No summary statistics are available given the limited data from the small number of evaluable participants and individual participant data are also not presented to protect the privacy of the individuals.,1.0,,Decision to terminate EZH-1401 was solely due to company business decision.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,INDUSTRY,,,,,,,2022,0.0
NCT03493854,,2018-04-04,2020-06-03,,2024-06-21,2018-04-04,2018-04-11,ACTUAL,2020-06-03,2020-06-25,ACTUAL,,,,2024-06-21,2024-06-26,ACTUAL,2018-06-14,ACTUAL,2018-06-14,2024-06,2024-06-30,2023-06-02,ACTUAL,2023-06-02,2019-07-04,ACTUAL,2019-07-04,,INTERVENTIONAL,FeDeriCa,,"A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer","A Phase III, Randomized, Multicenter, Open-Label, Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Patients With HER2-Positive Early Breast Cancer",COMPLETED,,PHASE3,500.0,ACTUAL,Hoffmann-La Roche,,2.0,,,t,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).~For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).",2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,INDUSTRY,,NCT04395508,APPROVED_FOR_MARKETING,,,,2023,1.0
NCT02578680,,2015-10-15,2018-09-11,,2024-09-05,2015-10-15,2015-10-19,ESTIMATED,2018-10-29,2018-11-28,ACTUAL,,,,2024-09-05,2024-09-20,ACTUAL,2016-01-15,ACTUAL,2016-01-15,2024-09,2024-09-30,2023-06-22,ACTUAL,2023-06-22,2017-11-08,ACTUAL,2017-11-08,,INTERVENTIONAL,,The Baseline Analysis Population consisted of all randomized participants.,Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189),"A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189)",COMPLETED,,PHASE3,616.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,INDUSTRY,,,,,,,2023,1.0
NCT04244552,,2020-01-21,,,2023-12-26,2020-01-24,2020-01-28,ACTUAL,,,,,,,2023-12-26,2023-12-29,ACTUAL,2020-02-11,ACTUAL,2020-02-11,2023-12,2023-12-31,2023-11-01,ACTUAL,2023-11-01,2023-11-01,ACTUAL,2023-11-01,,INTERVENTIONAL,,,A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies,"A Phase 1b Dose Escalation and Expansion Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Biological Activity of ATRC-101 as Monotherapy and in Combination With Other Anticancer Agents in Adults With Advanced Solid Malignancies",TERMINATED,,PHASE1,87.0,ACTUAL,"Atreca, Inc.",,4.0,,Sponsor Decision,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,INDUSTRY,,,,,,,2023,0.0
NCT04489940,,2020-07-27,2023-01-25,,2023-03-15,2020-07-27,2020-07-28,ACTUAL,2023-03-15,2023-04-10,ACTUAL,,,,2023-03-15,2023-04-10,ACTUAL,2020-10-12,ACTUAL,2020-10-12,2023-03,2023-03-31,2022-07-08,ACTUAL,2022-07-08,2022-01-27,ACTUAL,2022-01-27,,INTERVENTIONAL,,"The Full analysis set (FAS) included all participants, who were administered at least one infusion of bintrafusp alfa.",Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer,"A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With HMGA2-expressing Triple Negative Breast Cancer",TERMINATED,,PHASE2,11.0,ACTUAL,EMD Serono,"Based on sponsors decision for early termination of the study due to lack of probability to achieve interim data allowing expansion of this study.~Hence, analysis for efficacy, or biomarker were not performed.",1.0,,The study was prematurely discontinued by the sponsor due to probability of success which was too low to justify the continuation of recruitment.,f,,,,f,t,f,,,,,,Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union,Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.,http://bit.ly/IPD21,YES,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21",2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,INDUSTRY,,,,,,,2022,0.0
NCT04611958,,2020-10-27,,,2021-07-15,2020-10-27,2020-11-02,ACTUAL,,,,,,,2021-07-15,2021-07-21,ACTUAL,2021-07-01,ACTUAL,2021-07-01,2021-07,2021-07-31,2021-07-01,ACTUAL,2021-07-01,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,,,Intraductal Liposomal Bupivacaine for Chronic Pancreatitis,Intraductal Liposomal Bupivacaine as a Therapeutic Trial to Determine the Contribution of Peripheral Versus Central Sensitization in the Pathogenesis of Pain in Chronic Pancreatitis- a Pilot and Feasibility Study,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Johns Hopkins University,,1.0,,The FDA requirements for the IND are not feasible to complete.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,OTHER,,,,,,,2021,0.0
NCT04398290,,2020-05-20,,,2020-08-17,2020-05-20,2020-05-21,ACTUAL,,,,,,,2020-08-17,2020-08-19,ACTUAL,2020-12-01,ESTIMATED,2020-12-01,2020-08,2020-08-31,2021-07-15,ESTIMATED,2021-07-15,2021-06-01,ESTIMATED,2021-06-01,,INTERVENTIONAL,NO-COVER,,iNOPulse for COVID-19,Randomized Controlled Trial Of A Delivered Continuously By Nasal Cannula For The Treatment Of Patients With COVID-19 And Mild To Moderate Hypoxemia Requiring Supplemental Oxygen,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Miami,,2.0,,IRB AND FDA REVIEWS DEFERRED,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,OTHER,,,,,,,2021,0.0
NCT06417697,,2024-05-08,,,2024-09-19,2024-05-11,2024-05-16,ACTUAL,,,,,,,2024-09-19,2024-09-24,ACTUAL,2024-05-24,ACTUAL,2024-05-24,2024-09,2024-09-30,2024-09-09,ACTUAL,2024-09-09,2024-09-09,ACTUAL,2024-09-09,,INTERVENTIONAL,,,A Phase 1b Study to Evaluate the Safety of XEN-101,"A Phase 1b, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Effects of XEN-101 on Safety, Tolerability, and Pharmacodynamics in Subjects with Obesity",TERMINATED,,PHASE1,33.0,ACTUAL,Xeno Biosciences,,2.0,,Study not stopped for safety reasons. Data were reviewed after the first 23 patients had completed scheduled dosing and there was no signal of efficacy for change in body weight. This clinical trial has been determined to be futile.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,,,,,,2024,0.0
NCT02303795,,2014-11-19,,,2022-04-04,2014-11-25,2014-12-01,ESTIMATED,,,,,,,2022-04-04,2022-04-12,ACTUAL,2015-08,ACTUAL,2015-08-31,2022-04,2022-04-30,2020-08,ACTUAL,2020-08-31,2020-08,ACTUAL,2020-08-31,,INTERVENTIONAL,,,RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial,"A Phase 2, Randomized, Open Label, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Rivaroxaban Compared With Vitamin K Antagonism in Patients With Atrial Fibrillation With Bioprosthetic Mitral Valves - RIVER",COMPLETED,,PHASE2,1005.0,ACTUAL,Hospital do Coracao,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,OTHER,,,,,,,2020,1.0
NCT04969679,,2021-07-07,,,2021-07-16,2021-07-16,2021-07-21,ACTUAL,,,,,,,2021-07-16,2021-07-21,ACTUAL,2018-03-16,ACTUAL,2018-03-16,2021-07,2021-07-31,2020-06-03,ACTUAL,2020-06-03,2020-06-03,ACTUAL,2020-06-03,,INTERVENTIONAL,,,Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment.,"A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Mutaflor in Patients With Mild-to-moderate Ulcerative Colitis on 5-ASA Treatment.",COMPLETED,,PHASE4,134.0,ACTUAL,Kangbuk Samsung Hospital,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,OTHER,,,,,,,2020,1.0
NCT02192502,,2014-07-15,2022-09-21,,2023-02-09,2014-07-15,2014-07-16,ESTIMATED,2023-02-09,2023-02-14,ACTUAL,,,,2023-02-09,2023-02-14,ACTUAL,2015-03,ACTUAL,2015-03-31,2023-02,2023-02-28,2020-02,ACTUAL,2020-02-29,2018-02,ACTUAL,2018-02-28,,INTERVENTIONAL,SHARP,,Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients,A Randomized Controlled Investigation of the Effects of 6% Hydroxyethylstarch 130/0.4 (Voluven) on Renal Function in Patients Having Aortic Valve Replacement With or Without Coronary Artery Bypass Grafting,COMPLETED,,PHASE3,149.0,ACTUAL,The Cleveland Clinic,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,OTHER,,,,,,,2020,1.0
NCT04847232,,2021-04-08,,,2024-04-10,2021-04-14,2021-04-19,ACTUAL,,,,,,,2024-04-10,2024-04-11,ACTUAL,2021-04-30,ACTUAL,2021-04-30,2024-04,2024-04-30,2024-03-07,ACTUAL,2024-03-07,2024-03-07,ACTUAL,2024-03-07,,INTERVENTIONAL,,,Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes),"An International, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)",TERMINATED,,PHASE3,2698.0,ACTUAL,AstraZeneca,,2.0,,"The event rate observed in the study continued to be below primary assumptions, so that the completion of the study within a reasonable timeframe was deemed very unlikely.",f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,,,,,,2024,0.0
NCT03834506,,2019-02-06,2023-05-23,,2024-09-05,2019-02-06,2019-02-08,ACTUAL,2023-05-23,2023-06-18,ACTUAL,,,,2024-09-05,2024-09-20,ACTUAL,2019-05-02,ACTUAL,2019-05-02,2024-09,2024-09-30,2023-07-18,ACTUAL,2023-07-18,2022-06-20,ACTUAL,2022-06-20,,INTERVENTIONAL,,The baseline analysis population consisted of all randomized participants.,Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921),"A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)",COMPLETED,,PHASE3,1030.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,INDUSTRY,,,,,,,2023,1.0
NCT05438602,,2022-06-28,2024-07-15,,2024-09-16,2022-06-28,2022-06-30,ACTUAL,2024-09-16,2024-09-23,ACTUAL,,,,2024-09-16,2024-09-23,ACTUAL,2022-08-03,ACTUAL,2022-08-03,2024-09,2024-09-30,2023-11-13,ACTUAL,2023-11-13,2023-07-17,ACTUAL,2023-07-17,,INTERVENTIONAL,,Safety population included all randomised participants who received at least 1 dose of the study intervention.,A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System,"AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE NIRMATRELVIR/RITONAVIR IN NONHOSPITALIZED PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH SYMPTOMATIC COVID-19 WHO ARE IMMUNOCOMPROMISED",COMPLETED,,PHASE2,158.0,ACTUAL,Pfizer,"For outcome measure data have not been reported for RP separately, since there was 1 participant each in 2 arms (Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day and Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 day), it could have led to re-identification of RP participants. In other sections of results data for RP and MSP have been combined.",3.0,,,f,,,,,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,INDUSTRY,,,,,,,2023,1.0
NCT04085991,,2019-09-08,,,2023-04-10,2019-09-10,2019-09-11,ACTUAL,,,,,,,2023-04-10,2023-04-12,ACTUAL,2020-07-31,ACTUAL,2020-07-31,2023-04,2023-04-30,2023-01-15,ACTUAL,2023-01-15,2023-01-15,ACTUAL,2023-01-15,,INTERVENTIONAL,CROSSBOW,,Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer,Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer,TERMINATED,,PHASE2,11.0,ACTUAL,Sir Mortimer B. Davis - Jewish General Hospital,,1.0,,Drug no longer available,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,OTHER,,,,,,,2023,0.0
NCT03756129,,2018-11-13,2021-02-15,,2021-10-07,2018-11-26,2018-11-28,ACTUAL,2021-04-28,2021-05-19,ACTUAL,,,,2021-10-07,2021-10-08,ACTUAL,2019-02-08,ACTUAL,2019-02-08,2021-10,2021-10-31,2020-03-23,ACTUAL,2020-03-23,2020-03-23,ACTUAL,2020-03-23,,INTERVENTIONAL,,,Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression,"A Multi-center, Randomized, subject-and Investigator Blinded, Placebo-controlled, Active Comparator, Parallel-group Proof of Concept Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Patients With Treatment-resistant Depression",COMPLETED,,PHASE2,70.0,ACTUAL,Novartis,,6.0,,,f,,,,f,t,f,,,,,,,,https://www.clinicalstudydatarequest.com/,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,,,,,,2020,1.0
NCT04677179,,2020-12-08,2023-08-08,,2023-08-08,2020-12-17,2020-12-21,ACTUAL,2023-08-08,2023-09-05,ACTUAL,,,,2023-08-08,2023-09-05,ACTUAL,2021-03-22,ACTUAL,2021-03-22,2023-08,2023-08-31,2022-08-09,ACTUAL,2022-08-09,2022-08-09,ACTUAL,2022-08-09,,INTERVENTIONAL,INSTRUCT-UC,All randomized participants.,A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC),"An Adaptive Phase 2, Randomized, Double Blind, Placebo Controlled Study of LY3471851 (NKTR 358) in Patients With Moderately to Severely Active Ulcerative Colitis",TERMINATED,,PHASE2,81.0,ACTUAL,Nektar Therapeutics,,3.0,,Study terminated due to enrollment futility.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,,,,,,2022,0.0
NCT03252093,,2017-08-01,,,2022-05-24,2017-08-14,2017-08-17,ACTUAL,,,,,,,2022-05-24,2022-05-26,ACTUAL,2017-07-20,ACTUAL,2017-07-20,2022-05,2022-05-31,2022-11-15,ESTIMATED,2022-11-15,2022-11-15,ESTIMATED,2022-11-15,,INTERVENTIONAL,,,Evaluation of the Safety and Efficacy of Ang-(1-7) to Enhance Cognitive Function in Participants Undergoing CABG,"A Randomized, Placebo-controlled, Double Blind Evaluation of the Safety and Efficacy of Angiotensin 1-7 (Ang-(1-7)) to Enhance Cognitive Function in Participants Undergoing Coronary Artery Bypass Graft (CABG) Surgery.",SUSPENDED,,PHASE2,6.0,ACTUAL,University of Arizona,,2.0,,Due to funding,f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,OTHER,,,,,,,2022,0.0
NCT04178902,,2019-11-25,,,2021-07-20,2019-11-25,2019-11-26,ACTUAL,,,,,,,2021-07-20,2021-07-26,ACTUAL,2020-05-19,ACTUAL,2020-05-19,2021-07,2021-07-31,2021-04-16,ACTUAL,2021-04-16,2021-04-16,ACTUAL,2021-04-16,,INTERVENTIONAL,,,A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma,"A First In Human Study of the MCL-1 Inhibitor, ABBV-467",TERMINATED,,PHASE1,8.0,ACTUAL,AbbVie,,2.0,,Strategic considerations,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,INDUSTRY,,,,,,,2021,0.0
NCT04538833,,2020-08-30,,,2022-11-19,2020-09-01,2020-09-04,ACTUAL,,,,,,,2022-11-19,2022-11-23,ACTUAL,2020-09-09,ACTUAL,2020-09-09,2022-11,2022-11-30,2022-08-22,ACTUAL,2022-08-22,2022-08-22,ACTUAL,2022-08-22,,INTERVENTIONAL,,,GM1 in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel,"Monosialoganglioside in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel : a Multicenter, Double-blind, Randomized Controlled Phase II Clinical Trial",WITHDRAWN,,PHASE2,0.0,ACTUAL,Henan Cancer Hospital,,2.0,,"In the clinical treatment, no patient with a score of less than 38(FACT Ntx Score) points after 1-2 weeks of application of albumin bound paclitaxel in this project, therefore, there is no suitable subject after screening",f,,,,,f,f,,,,,,,,,,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,OTHER_GOV,,,,,,,2022,0.0
NCT03760445,,2018-11-13,,,2020-01-06,2018-11-28,2018-11-30,ACTUAL,,,,,,,2020-01-06,2020-01-09,ACTUAL,2019-11-15,ESTIMATED,2019-11-15,2020-01,2020-01-31,2023-06-13,ESTIMATED,2023-06-13,2021-07-22,ESTIMATED,2021-07-22,,INTERVENTIONAL,,,HDM201 Added to CT in R/R or Newly Diagnosed AML,A Phase I/II Multi-center Study of HDM201 Added to Chemotherapy in Adult Subjects With Relapsed/Refractory (R/R) or Newly Diagnosed Acute Myeloid Leukemia (AML),WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Novartis,,8.0,,It was determined that the study design may not be optimal given the changing AML treatment landscape.,f,,,,f,t,f,,,,,,,,,UNDECIDED,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.",2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,,,,,,2023,0.0
NCT04464174,,2020-07-06,,,2024-07-24,2020-07-06,2020-07-09,ACTUAL,,,,,,,2024-07-24,2024-07-26,ACTUAL,2020-10-08,ACTUAL,2020-10-08,2022-06,2022-06-30,2023-11-10,ACTUAL,2023-11-10,2023-11-10,ACTUAL,2023-11-10,,INTERVENTIONAL,PATHFINDER,,Ipatasertib Plus Non-Taxane Chemotherapy for Advanced or Metastatic Triple-Negative Breast Cancer,"A Multicenter, Open-Label, Non-Comparative, Three-Arm, Phase IIa Trial of Ipatasertib (GDC-0068) in Combination With Non-Taxane Chemotherapy Agents for Taxane-Pretreated Unresectable Locally Advanced or Metastatic TNBC Patients",COMPLETED,,PHASE2,54.0,ACTUAL,MedSIR,,3.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,OTHER,,,,,,,2023,1.0
NCT02073838,,2014-02-21,,,2023-09-28,2014-02-25,2014-02-27,ESTIMATED,,,,,,,2023-09-28,2023-09-29,ACTUAL,2015-05,ACTUAL,2015-05-31,2023-09,2023-09-30,2022-11,ACTUAL,2022-11-30,2022-11,ACTUAL,2022-11-30,,INTERVENTIONAL,,,Ribavirin and Hedgehog Inhibitor With or Without Decitabine in AML,"A Phase II, Multi-center, Open Label, Randomized Study of Ribavirin and Hedgehog Inhibitor With or Without Decitabine in Acute Myeloid Leukemia (AML)",COMPLETED,,PHASE2,23.0,ACTUAL,Jewish General Hospital,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,OTHER,,,,,,,2022,1.0
NCT01413620,,2011-08-09,,,2021-09-20,2011-08-09,2011-08-10,ESTIMATED,,,,,,,2021-09-20,2021-09-21,ACTUAL,2011-08,,2011-08-31,2021-09,2021-09-30,2021-08,ESTIMATED,2021-08-31,2017-08,ESTIMATED,2017-08-31,,INTERVENTIONAL,,,Vitamin E Supplementation in Burn Patients,Vitamin E Supplementation in Burn Patients,WITHDRAWN,,PHASE1,0.0,ACTUAL,Shriners Hospitals for Children,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,OTHER,,,,,,,2021,0.0
NCT01949311,,2013-09-20,2023-06-23,,2023-10-16,2013-09-20,2013-09-24,ESTIMATED,2023-10-16,2023-10-17,ACTUAL,,,,2023-10-16,2023-10-17,ACTUAL,2013-10-10,ACTUAL,2013-10-10,2023-10,2023-10-31,2022-06-27,ACTUAL,2022-06-27,2022-06-27,ACTUAL,2022-06-27,,INTERVENTIONAL,,,Open-label Study of Dupilumab in Patients With Atopic Dermatitis,An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials,COMPLETED,,PHASE3,2733.0,ACTUAL,Regeneron Pharmaceuticals,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 14:00:57.620255,2024-10-15 14:00:57.620255,INDUSTRY,,,,,,,2022,1.0
NCT03521232,,2018-04-17,,,2022-11-28,2018-05-09,2018-05-11,ACTUAL,,,,,,,2022-11-28,2022-11-29,ACTUAL,2018-05-15,ACTUAL,2018-05-15,2022-08,2022-08-31,2022-10-04,ACTUAL,2022-10-04,2022-09-19,ACTUAL,2022-09-19,,INTERVENTIONAL,,,A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis,"A Phase I/IIA, Open-Label, Three-Stage Study to Investigate the Safety, the Efficacy and the Pharmacokinetics of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Procto-Sigmoiditis",TERMINATED,,PHASE1/PHASE2,27.0,ACTUAL,Entero Therapeutics,,2.0,,Covid-19,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,INDUSTRY,,,,,,,2022,0.0
NCT04031846,,2019-07-22,2022-03-09,,2023-07-20,2019-07-22,2019-07-24,ACTUAL,2022-06-23,2023-05-03,ACTUAL,,,,2023-07-20,2023-07-28,ACTUAL,2019-09-04,ACTUAL,2019-09-04,2023-07,2023-07-31,2021-08-05,ACTUAL,2021-08-05,2021-08-05,ACTUAL,2021-08-05,,INTERVENTIONAL,PNEU-PED-EU-1,,"Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)","A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (PNEU-PED-EU-1)",COMPLETED,,PHASE3,1184.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,f,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,INDUSTRY,,,,,,,2021,1.0
NCT05079451,,2021-09-02,,,2023-09-06,2021-10-12,2021-10-15,ACTUAL,,,,,,,2023-09-06,2023-09-07,ACTUAL,2024-01-01,ESTIMATED,2024-01-01,2023-08,2023-08-31,2024-02-15,ESTIMATED,2024-02-15,2024-01-15,ESTIMATED,2024-01-15,,INTERVENTIONAL,,,Broadly Neutralizing Antibodies 3BNC117-LS & 10-1074-LS to Prevent Relapse During ATI,"A Phase I, Open-Label Study of the Safety and Ability of Broadly Neutralizing Antibodies 3BNC117-LS and 10-1074-LS in Combination to Durably Prevent Viral Relapse During a Monitored Analytical Treatment Interruption",WITHDRAWN,,PHASE1,0.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,1.0,,Protocol Withdrawal,f,,,,,t,f,,,,,,Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.,* With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism will data be made available? Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.,,YES,"Individual participant data that underlie results in the publication, after deidentification.",2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,NIH,,,,,,,2024,0.0
NCT03442751,,2018-02-16,2023-06-22,2020-12-16,2024-01-29,2018-02-16,2018-02-22,ACTUAL,2024-01-29,2024-01-30,ACTUAL,,2024-01-30,ACTUAL,2024-01-29,2024-01-30,ACTUAL,2018-04-06,ACTUAL,2018-04-06,2024-01,2024-01-31,2020-08-10,ACTUAL,2020-08-10,2019-11-01,ACTUAL,2019-11-01,,INTERVENTIONAL,,Subjects with progressive keratoconus in at least one eye (study eye). Subjects may contribute more than one eye if both eyes qualify. Eyes vs. subjects were randomized to the treatment arms.,Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus,"A Phase III, Multi-center Study to Evaluate the Safety and Efficacy of Epithelium-on Corneal Collagen Cross-linking in Eyes With Progressive Keratoconus",COMPLETED,,PHASE3,201.0,ACTUAL,Glaukos Corporation,,2.0,,,f,,,,f,t,t,t,,,,,,,,NO,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,INDUSTRY,,,,,Eyes,,2020,1.0
NCT05333289,,2022-04-11,2023-11-21,,2024-01-08,2022-04-11,2022-04-18,ACTUAL,2024-01-08,2024-02-01,ACTUAL,,,,2024-01-08,2024-02-01,ACTUAL,2022-04-06,ACTUAL,2022-04-06,2024-01,2024-01-31,2022-11-22,ACTUAL,2022-11-22,2022-11-22,ACTUAL,2022-11-22,,INTERVENTIONAL,,The Randomization Set consisted of all participants who were randomly assigned.,A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults,"Phase 1/2, Randomized, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1020 and mRNA-1030 Candidate Seasonal Influenza Vaccines in Healthy Adults",COMPLETED,,PHASE1/PHASE2,572.0,ACTUAL,"ModernaTX, Inc.",,8.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,INDUSTRY,,,,,,,2022,0.0
NCT04839965,,2021-04-08,2022-10-17,,2022-11-09,2021-04-08,2021-04-09,ACTUAL,2022-11-09,2022-11-30,ACTUAL,,,,2022-11-09,2022-11-30,ACTUAL,2021-07-05,ACTUAL,2021-07-05,2022-03,2022-03-31,2022-04-04,ACTUAL,2022-04-04,2022-02-07,ACTUAL,2022-02-07,,INTERVENTIONAL,,,Study of Intravenous Ampion in Adult COVID-19 Patients Requiring Supplemental Oxygen,"A Randomized, Double-Blinded, Placebo Controlled Phase II Study to Evaluate the Safety and Efficacy of IV Ampion in Adult COVID-19 Patients Requiring Oxygen Supplementation",TERMINATED,,PHASE2,36.0,ACTUAL,Ampio Pharmaceuticals. Inc.,The AP-017 study was prematurely terminated by the sponsor after an interim analysis.,2.0,,The AP-017 study was prematurely terminated by the sponsor after an interim analysis.,,,,,t,t,f,,,,,,,,,,,2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,INDUSTRY,,,,,,,2022,0.0
NCT02926248,,2016-06-24,,,2020-07-27,2016-10-05,2016-10-06,ESTIMATED,,,,,,,2020-07-27,2020-07-28,ACTUAL,2016-05,,2016-05-31,2020-07,2020-07-31,2021-03,ESTIMATED,2021-03-31,2020-03-21,ACTUAL,2020-03-21,,INTERVENTIONAL,Colchine MUA,,Effect of Colchicine on Range of Motion After Manipulation Under Anesthesia for the Stiff Total Knee Replacement,Effect of Colchicine on Range of Motion After Manipulation Under Anesthesia for the Stiff Total Knee Replacement: A Prospective Randomized Controlled Trial,SUSPENDED,,PHASE4,112.0,ESTIMATED,"Hospital for Special Surgery, New York",,2.0,,Continuing IRB review was not submitted. Study was inactivated with the institutional IRB.,f,,,,f,,,,,,,,,,,NO,,2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,OTHER,,,,,,,2021,0.0
NCT02506517,,2015-07-15,,,2023-07-28,2015-07-21,2015-07-23,ESTIMATED,,,,,,,2023-07-28,2023-08-01,ACTUAL,2015-08,,2015-08-31,2023-07,2023-07-31,2023-05-04,ACTUAL,2023-05-04,2023-05-04,ACTUAL,2023-05-04,,INTERVENTIONAL,,,A Study of Afatinib in Patients With Advanced Cancer With Changes in the HER Gene,Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies,COMPLETED,,PHASE2,12.0,ACTUAL,"University Health Network, Toronto",,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,OTHER,,,,,,,2023,1.0
NCT03678428,,2018-09-18,,,2023-02-14,2018-09-18,2018-09-19,ACTUAL,,,,,,,2023-02-14,2023-02-16,ACTUAL,2021-12-31,ACTUAL,2021-12-31,2023-02,2023-02-28,2022-12-31,ACTUAL,2022-12-31,2022-10-31,ACTUAL,2022-10-31,,INTERVENTIONAL,,,FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM,FUDR/Oxaliplatin HAI Plus Irinotecan Chemotherapy vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM,TERMINATED,,PHASE3,92.0,ACTUAL,Sun Yat-sen University,,2.0,,Production halt of FUDR in China,f,,,,,f,f,,,,,,,,,,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,OTHER,,,,,,,2022,0.0
NCT03926130,,2019-04-23,,,2023-12-07,2019-04-23,2019-04-24,ACTUAL,,,,,,,2023-12-07,2023-12-08,ACTUAL,2019-07-23,ACTUAL,2019-07-23,2023-12,2023-12-31,2023-10-02,ACTUAL,2023-10-02,2023-08-23,ACTUAL,2023-08-23,,INTERVENTIONAL,VIVID-1,,A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease,"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease",COMPLETED,,PHASE3,1158.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,INDUSTRY,,,,,,,2023,1.0
NCT03764774,,2018-12-04,,,2020-12-18,2018-12-04,2018-12-05,ACTUAL,,,,,,,2020-12-18,2020-12-21,ACTUAL,2018-12-06,ACTUAL,2018-12-06,2020-12,2020-12-31,2020-12-07,ACTUAL,2020-12-07,2020-12-07,ACTUAL,2020-12-07,,INTERVENTIONAL,,,A Study of LY3463251 in Healthy Participants,"A Randomized, Placebo-Controlled, Subject- and Investigator-Blind, Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetics Study of LY3463251 in Healthy and Overweight Healthy Subjects",TERMINATED,,PHASE1,118.0,ACTUAL,Eli Lilly and Company,,4.0,,Trial was terminated due to an insufficient benefit/tolerability ratio,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,INDUSTRY,,,,,,,2020,0.0
NCT04432766,,2020-06-12,,,2021-08-06,2020-06-15,2020-06-16,ACTUAL,,,,,,,2021-08-06,2021-08-12,ACTUAL,2020-10-20,ESTIMATED,2020-10-20,2021-08,2021-08-31,2021-08-18,ESTIMATED,2021-08-18,2021-01-20,ESTIMATED,2021-01-20,,INTERVENTIONAL,,,A Phase 1/2 Study to Assess Safety and Efficacy of BAT2020 in Hospitalized COVID-19 Patients,"A Phase 1/2, Multi-Center, Randomized Study to Assess Safety, Pharmacokinetics, Immunogenicity, and Efficacy of BAT2020 in Hospitalized Patients Infected With SARS-CoV-2 (COVID-19)",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Bio-Thera Solutions,,3.0,,strategic decision,f,,,,,t,f,,,f,,,,,,,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,INDUSTRY,,,,,,,2021,0.0
NCT03945188,,2019-05-08,2022-11-28,,2022-11-28,2019-05-08,2019-05-10,ACTUAL,2022-11-28,2022-12-20,ACTUAL,,,,2022-11-28,2022-12-20,ACTUAL,2019-06-13,ACTUAL,2019-06-13,2022-03,2022-03-31,2022-02-16,ACTUAL,2022-02-16,2022-02-08,ACTUAL,2022-02-08,,INTERVENTIONAL,ELEVATE UC 52,Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study treatment.,Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis",COMPLETED,,PHASE3,433.0,ACTUAL,Arena Pharmaceuticals,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,INDUSTRY,,,,,,,2022,1.0
NCT02813655,,2016-06-22,,,2023-11-14,2016-06-24,2016-06-27,ESTIMATED,,,,,,,2023-11-14,2023-11-18,ACTUAL,2016-10,ACTUAL,2016-10-31,2023-11,2023-11-30,2022-11-21,ACTUAL,2022-11-21,2022-11,ACTUAL,2022-11-30,,INTERVENTIONAL,ESYBRECHE,,Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE),Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE),TERMINATED,,PHASE2,46.0,ACTUAL,Hospices Civils de Lyon,,2.0,,"Interim analysis and decision of the independent committee, investigators and sponsor (futility) (2023/10/05)",f,,,,t,,,,,,,,,,,,,2024-10-15 00:06:19.604021,2024-10-15 00:06:19.604021,OTHER,,,,,,,2022,0.0
NCT05074394,,2021-10-07,,,2022-01-21,2021-10-07,2021-10-12,ACTUAL,,,,,,,2022-01-21,2022-02-03,ACTUAL,2021-11,ESTIMATED,2021-11-30,2022-01,2022-01-31,2023-01,ESTIMATED,2023-01-31,2022-11,ESTIMATED,2022-11-30,,INTERVENTIONAL,US,,Randomized Study to Evaluate Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With Mild COVID-19 Infection,"A Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal STI-2099 (COVI-DROPS™) as Treatment for COVID-19 Infection in Outpatient Adults",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,2.0,,to be replaced with a different protocol,f,,,,,t,f,,,,,,,,,,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,INDUSTRY,,,,,,,2023,0.0
NCT02962102,,2016-11-03,2021-12-07,,2022-01-05,2016-11-09,2016-11-11,ESTIMATED,2022-01-05,2022-02-03,ACTUAL,,,,2022-01-05,2022-02-03,ACTUAL,2017-04-03,ACTUAL,2017-04-03,2022-01,2022-01-31,2020-08-06,ACTUAL,2020-08-06,2020-07-16,ACTUAL,2020-07-16,,INTERVENTIONAL,ACTIVATE-AKI,,Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury,Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury (ACTIVATE-AKI),COMPLETED,,PHASE2,150.0,ACTUAL,Brigham and Women's Hospital,Limited sample size and AKI event rate,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,OTHER,,,,,,,2020,1.0
NCT04726592,,2021-01-24,,,2024-07-30,2021-01-26,2021-01-27,ACTUAL,,,,,,,2024-07-30,2024-08-02,ACTUAL,2021-07-08,ACTUAL,2021-07-08,2024-06,2024-06-30,2024-04-10,ACTUAL,2024-04-10,2024-04-10,ACTUAL,2024-04-10,,INTERVENTIONAL,,,Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room,Randomized Double Blinded Monocentric Study Evaluating the Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room,TERMINATED,,PHASE3,323.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,It has been determined that continuing with enrollments in this study is no longer justified due to the lack of significant impact on the expected outcomes.,f,,,,,f,f,,,,,,,,,,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,OTHER,,,,,,,2024,0.0
NCT04955574,,2021-06-11,,,2023-06-26,2021-07-05,2021-07-09,ACTUAL,,,,,,,2023-06-26,2023-06-28,ACTUAL,2023-01,ESTIMATED,2023-01-31,2023-06,2023-06-30,2024-12,ESTIMATED,2024-12-31,2024-01,ESTIMATED,2024-01-31,,INTERVENTIONAL,,,Probiotic and Antibiotic Therapies in Women With Unexplained Infertility,Probiotic and Antibiotic Therapies in Women With Unexplained Infertility,WITHDRAWN,,PHASE2,0.0,ACTUAL,McMaster University,,3.0,,Change in departmental research focus.,f,,,,,f,f,,,f,,,,,,NO,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,OTHER,,,,,,,2024,0.0
NCT02636270,,2015-11-10,2023-11-09,,2024-02-26,2015-12-16,2015-12-21,ESTIMATED,2024-02-26,2024-02-28,ACTUAL,,,,2024-02-26,2024-02-28,ACTUAL,2015-12-21,ACTUAL,2015-12-21,2024-02,2024-02-29,2022-12-01,ACTUAL,2022-12-01,2022-10-14,ACTUAL,2022-10-14,,INTERVENTIONAL,,,IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency,Treatment With Recombinant Human Insulin-like Growth Factor 1 (rhIGF-1) in Patients With Pappalysin-2 (PAPP-A2) Gene Mutation.,COMPLETED,,PHASE1/PHASE2,7.0,ACTUAL,"Children's Hospital Medical Center, Cincinnati",,1.0,,,f,,,,t,,,,,,,,"The participant data will be available when the treatment trial is actively ongoing. Per study protocol, the study will provide clinical updates to the participants primary Endocrinologist. Should the family request any further information be shared once the study is closed, it can be given to a physician specified by the family.",De-identifiable data may be shared with physician that is treating the only other two patients in the world with this genetic mutation.,,YES,De-identifiable data may be shared with physician that is treating the only other two patients in the world with this genetic mutation.,2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,OTHER,,,,,,,2022,1.0
NCT04189315,,2019-12-04,,,2020-06-01,2019-12-04,2019-12-06,ACTUAL,,,,,,,2020-06-01,2020-06-04,ACTUAL,2020-04,ESTIMATED,2020-04-30,2020-06,2020-06-30,2022-08,ESTIMATED,2022-08-31,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,REBUILD,,Relieving Burden of Hypophosphatasia in Adults With Functional Impairment Due to Chronic Disease,"A Phase 4, Randomized, Multicenter, Open-Label, 2-Dosage Regimen, Safety and Tolerability, Efficacy, Pharmacokinetic, and Pharmacodynamic Study of Asfotase Alfa in Adult Patients With Pediatric-Onset Hypophosphatasia",WITHDRAWN,,PHASE4,0.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,2.0,,R\&D portfolio review and in light of the global impact of the COVID-19 pandemic,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,INDUSTRY,,,,,,,2022,0.0
NCT03259425,,2017-08-18,2019-09-20,,2022-06-09,2017-08-22,2017-08-23,ACTUAL,2019-09-20,2019-10-10,ACTUAL,,,,2022-06-09,2022-06-13,ACTUAL,2018-01-03,ACTUAL,2018-01-03,2022-06,2022-06-30,2020-09-25,ACTUAL,2020-09-25,2018-09-21,ACTUAL,2018-09-21,,INTERVENTIONAL,,,"Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma","Phase II Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma (Neo-NivoHF10)",TERMINATED,,PHASE2,7.0,ACTUAL,University of Utah,,1.0,,DSMC Recommendation,f,,,,t,t,f,,,,,,,,,,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,OTHER,,,,,,,2020,0.0
NCT01960764,,2013-09-30,,,2020-11-03,2013-10-10,2013-10-11,ESTIMATED,,,,,,,2020-11-03,2020-11-05,ACTUAL,2016-06,,2016-06-30,2020-11,2020-11-30,2022-12,ESTIMATED,2022-12-31,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,Examination of Whether Host Preconditioning Modifies Short-term Transplant Survival,Phase 1 Study of Whether Host Preconditioning Modifies Short-term Transplant Survival,WITHDRAWN,,PHASE1,0.0,ACTUAL,"University of California, San Diego",,2.0,,This sub-study was not done because main study results reached significance.,f,,,,f,,,,,,,,,,,,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,OTHER,,,,,,,2022,0.0
NCT04087993,,2019-08-29,,,2024-08-27,2019-09-10,2019-09-12,ACTUAL,,,,,,,2024-08-27,2024-08-28,ACTUAL,2020-05-15,ESTIMATED,2020-05-15,2024-08,2024-08-31,2020-12-31,ESTIMATED,2020-12-31,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,IDA-I,,Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients,"Randomised, Open Lable, Active Controlled Clinical Trial to Demonstrate Safety and Efficacy of an i.v. Administration of Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients With Elective Non-cardiac Surgery (IDA I)",WITHDRAWN,,PHASE3,0.0,ACTUAL,Fraunhofer Institute for Translational Medicine and Pharmacology ITMP,,3.0,,difficult recruitment - redesign in discussion,f,,,,t,f,f,,,,,,,,,,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,OTHER,,,,,,,2020,0.0
NCT03935594,,2019-04-30,2022-10-24,,2022-12-13,2019-04-30,2019-05-02,ACTUAL,2022-12-13,2023-01-09,ACTUAL,,,,2022-12-13,2023-01-09,ACTUAL,2020-09-18,ACTUAL,2020-09-18,2022-12,2022-12-31,2022-10-19,ACTUAL,2022-10-19,2021-05-24,ACTUAL,2021-05-24,,INTERVENTIONAL,,,Use of Autologous Platelet-Rich Plasma to Treat Hypertrophic Burn Scars,Use of Autologous Platelet-Rich Plasma to Treat Hypertrophic Burn Scars; A Randomized Controlled Double-Blinded Trial,TERMINATED,,PHASE2,3.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,Intervention causing discomfort to participants,f,,,,t,t,f,,,f,,,,,,NO,"All reasonable efforts will be made to keep a patient's protected health information (PHI) private and confidential. Electronic records will be stored in restricted access database (Redcap, Vanderbilt) open only to the study team or on sponsor electronic databases which are password protected.",2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,OTHER,,,,,,,2022,0.0
NCT04620746,,2020-11-03,2023-06-02,,2023-09-20,2020-11-03,2020-11-09,ACTUAL,2023-09-20,2023-09-21,ACTUAL,,,,2023-09-20,2023-09-21,ACTUAL,2021-06-01,ACTUAL,2021-06-01,2023-09,2023-09-30,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,Penicillin Allergy Testing in STD Clinics,Validate an Easy to Administer Algorithm to Define Penicillin (PCN-B-lactam) Allergy Status in Sexually Transmitted Disease (STD) Clinic Outpatients,COMPLETED,,PHASE4,284.0,ACTUAL,Johns Hopkins University,,2.0,,,f,,,,f,t,f,,,f,,,Data will be uploaded and provided when study is completed and analyzed. Completed May 2023,,,YES,Blinded data set is available,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,OTHER,,,,,,,2022,1.0
NCT01566695,,2012-03-27,2020-01-25,,2024-01-24,2012-03-28,2012-03-29,ESTIMATED,2020-02-12,2020-02-26,ACTUAL,,,,2024-01-24,2024-01-26,ACTUAL,2013-04-26,ACTUAL,2013-04-26,2024-01,2024-01-31,2023-12-21,ACTUAL,2023-12-21,2019-01-25,ACTUAL,2019-01-25,,INTERVENTIONAL,,"The intent-to-treat (ITT) population included all participants who were randomized, regardless of whether they received treatment or not.",The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS),"A Phase 3, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia Due to IPSS Lower-risk Myelodysplastic Syndromes.",COMPLETED,,PHASE3,216.0,ACTUAL,Celgene,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,INDUSTRY,,,,,,,2023,1.0
NCT03492125,,2018-03-24,,,2024-09-20,2018-04-02,2018-04-10,ACTUAL,,,,,,,2024-09-20,2024-09-24,ACTUAL,2018-05-25,ACTUAL,2018-05-25,2024-09,2024-09-30,2023-11-28,ACTUAL,2023-11-28,2023-11-28,ACTUAL,2023-11-28,,INTERVENTIONAL,,,A Study of the Selective PKC-β Inhibitor MS- 553,A Phase I/II Dose-Escalation and Expansion Study of the Selective PKC-β Inhibitor MS-553 in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma,TERMINATED,,PHASE1/PHASE2,63.0,ACTUAL,"MingSight Pharmaceuticals, Inc",,8.0,,The study is terminated due to major protocol revisions. A new study in CLL patients is planned.,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,,,,,,2023,0.0
NCT01556191,,2012-03-08,,,2021-01-06,2012-03-15,2012-03-16,ESTIMATED,,,,,,,2021-01-06,2021-01-08,ACTUAL,2012-05-15,ACTUAL,2012-05-15,2021-01,2021-01-31,2020-06-17,ACTUAL,2020-06-17,2018-05-15,ACTUAL,2018-05-15,,INTERVENTIONAL,LADIE,,Lung Cancer in Women Treated With Anti-oestrogens anD Inhibitors of EGFR,Phase II Randomised Clinical Trial Evaluating an EGFR Tyrosine Kinase Inhibitor (EGFR-TKI) Versus an EGFR-TKI Combined With an Anti-oestrogen Treatment (Fulvestrant) in Women With Advanced Stage Non-squamous Lung Cancer,COMPLETED,,PHASE2,379.0,ACTUAL,Intergroupe Francophone de Cancerologie Thoracique,,4.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,OTHER,,,,,,,2020,0.0
NCT04958044,,2021-06-24,,,2022-10-25,2021-07-01,2021-07-12,ACTUAL,,,,,,,2022-10-25,2022-10-26,ACTUAL,2021-05-25,ACTUAL,2021-05-25,2022-10,2022-10-31,2022-06-13,ACTUAL,2022-06-13,2022-06-13,ACTUAL,2022-06-13,,INTERVENTIONAL,,,Endoscopic Assisted Calcium Electroporation in Esophageal Cancer,Endoscopic Assisted Calcium Electroporation in Esophageal Cancer - a Safety Study,COMPLETED,,PHASE1,10.0,ACTUAL,"Rigshospitalet, Denmark",,1.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,OTHER,,,,,,,2022,1.0
NCT03608033,,2018-06-21,,,2024-03-12,2018-07-23,2018-07-31,ACTUAL,,,,,,,2024-03-12,2024-03-15,ACTUAL,2018-02-16,ACTUAL,2018-02-16,2024-03,2024-03-31,2023-10-18,ACTUAL,2023-10-18,2023-10-16,ACTUAL,2023-10-16,,INTERVENTIONAL,,,Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy,"A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN)",TERMINATED,,PHASE3,356.0,ACTUAL,Omeros Corporation,,2.0,,"IA did not show positive results. Study is terminated, and in process of closing",f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,INDUSTRY,,,,,,,2023,0.0
NCT02052908,,2014-01-30,,,2021-01-22,2014-01-30,2014-02-03,ESTIMATED,,,,,,,2021-01-22,2021-01-25,ACTUAL,2014-01-27,ACTUAL,2014-01-27,2021-01,2021-01-31,2021-01-05,ACTUAL,2021-01-05,2019-10-25,ACTUAL,2019-10-25,,INTERVENTIONAL,,,Naproxen in Preventing DNA Mismatch Repair Deficient Colorectal Cancer in Patients With Lynch Syndrome,A Phase Ib Biomarker Trial of Naproxen in Patients at Risk for DNA Mismatch Repair Deficient Colorectal Cancer,COMPLETED,,PHASE1,81.0,ACTUAL,National Cancer Institute (NCI),,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,NIH,,,,,,,2021,1.0
NCT04671420,,2020-03-30,,,2020-12-10,2020-12-10,2020-12-17,ACTUAL,,,,,,,2020-12-10,2020-12-17,ACTUAL,2020-10,ESTIMATED,2020-10-31,2020-12,2020-12-31,2022-10,ESTIMATED,2022-10-31,2022-04,ESTIMATED,2022-04-30,,INTERVENTIONAL,,,Evaluate the Efficacy and Safety of HLX01 Versus Mabthera in Patients With Low Tumour Burden Follicular Lymphoma.,"A Phase 3 Multi-Centre, Randomised, Double-Blind, Parallel-Arm Study to Evaluate the Efficacy and Safety of HLX01 Versus Rituximab (Mabthera®) as First Line Treatment in Patients With Low Tumour Burden Follicular Lymphoma.",WITHDRAWN,,PHASE3,0.0,ACTUAL,Shanghai Henlius Biotech,,2.0,,sponsor strategy decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,INDUSTRY,,,,,,,2022,0.0
NCT02477540,,2015-06-10,,,2019-03-21,2015-06-19,2015-06-22,ESTIMATED,,,,,,,2019-03-21,2019-03-22,ACTUAL,2019-12,ESTIMATED,2019-12-31,2019-03,2019-03-31,2020-06,ESTIMATED,2020-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,A Safety and Efficacy Study of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia,"An Open Labeled, Single-center, Phase I Study Assessing the Safety and Efficacy of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Pharmicell Co., Ltd.",,1.0,,Study was stopped by sponsers internal reason.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,INDUSTRY,,,,,,,2020,0.0
NCT02445248,,2015-05-05,2023-12-16,,2024-03-22,2015-05-14,2015-05-15,ESTIMATED,2024-03-22,2024-04-18,ACTUAL,,,,2024-03-22,2024-04-18,ACTUAL,2015-07-29,ACTUAL,2015-07-29,2024-03,2024-03-31,2022-12-22,ACTUAL,2022-12-22,2022-12-22,ACTUAL,2022-12-22,,INTERVENTIONAL,JULIET,Full analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel.,Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients,"A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)",COMPLETED,,PHASE2,115.0,ACTUAL,Novartis,,1.0,,,t,,,,t,t,f,,,,,,,,https://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,INDUSTRY,,NCT03601442,AVAILABLE,,,,2022,1.0
NCT04003155,,2019-06-27,2022-07-13,2021-10-28,2023-09-01,2019-06-27,2019-07-01,ACTUAL,2022-07-13,2022-08-12,ACTUAL,2021-10-28,2021-11-01,ACTUAL,2023-09-01,2023-09-06,ACTUAL,2019-07-11,ACTUAL,2019-07-11,2023-08,2023-08-31,2021-08-11,ACTUAL,2021-08-11,2020-10-29,ACTUAL,2020-10-29,,INTERVENTIONAL,Skylight 1,All randomized participants.,A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause,"A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, Followed by a Non-Controlled Extension Treatment Period, to Assess the Efficacy and Safety of Fezolinetant in Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause",COMPLETED,,PHASE3,527.0,ACTUAL,Astellas Pharma Inc,,5.0,,,f,,,,t,t,f,,,,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://www.clinicalstudydatarequest.com/,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,INDUSTRY,,,,,,,2021,1.0
NCT04662073,,2020-12-08,2022-09-30,,2023-06-09,2020-12-09,2020-12-10,ACTUAL,2022-11-17,2022-12-13,ACTUAL,,,,2023-06-09,2023-06-28,ACTUAL,2021-04-23,ACTUAL,2021-04-23,2023-06,2023-06-30,2022-03-04,ACTUAL,2022-03-04,2021-06-08,ACTUAL,2021-06-08,,INTERVENTIONAL,COPPS,No participants were enrolled in the placebo arm.,COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Camostat Sub-Protocol,"COVID-19 Outpatient Pragmatic Platform Study (COPPS): A Pragmatic Multi-arm, Adaptive, Phase 2, Blinded, Randomized Placebo-controlled Platform Trial to Assess the Efficacy of Different Investigational Therapeutics in Reducing Time to Disease Resolution or Viral Load Cessation, as Compared to Standard Supportive Care in Outpatients With COVID-19",TERMINATED,,PHASE2,2.0,ACTUAL,Stanford University,This study did not meet its planned enrollment and did not achieve statistical power as specified in the protocol.,2.0,,Enrollment into the camostat subprotocol was halted prematurely as a result of loss of equipoise due to external findings including those related to monoclonal antibodies.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,OTHER,,,,,,,2022,0.0
NCT03815682,,2019-01-14,,,2022-12-02,2019-01-23,2019-01-24,ACTUAL,,,,,,,2022-12-02,2022-12-06,ACTUAL,2018-10-24,ACTUAL,2018-10-24,2022-12,2022-12-31,2022-10-11,ACTUAL,2022-10-11,2022-09-07,ACTUAL,2022-09-07,,INTERVENTIONAL,,,RPTR-147 in Patients With Selected Solid Tumors and Lymphomas,A Phase 1/2 Study of Deep IL-15 Loaded T-Cells Alone and in Combination With Pembrolizumab in Patients With Select Solid Tumors and Lymphomas,TERMINATED,,PHASE1,23.0,ACTUAL,Repertoire Immune Medicines,,3.0,,Development program terminated,,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,,,,,,2022,0.0
NCT03332355,,2017-10-16,,,2023-05-22,2017-10-31,2017-11-06,ACTUAL,,,,,,,2023-05-22,2023-05-24,ACTUAL,2017-10-01,ACTUAL,2017-10-01,2022-06,2022-06-30,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 2,(STM-03) Phase I Study of Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 2,TERMINATED,,PHASE1,18.0,ACTUAL,"Vanquish Oncology, Inc.",,1.0,,Business Reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,INDUSTRY,,,,,,,2021,0.0
NCT05593445,,2022-10-21,2024-08-29,,2024-08-29,2022-10-21,2022-10-25,ACTUAL,2024-08-29,2024-09-24,ACTUAL,,,,2024-08-29,2024-09-24,ACTUAL,2022-11-18,ACTUAL,2022-11-18,2024-08,2024-08-31,2023-12-21,ACTUAL,2023-12-21,2023-09-01,ACTUAL,2023-09-01,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus,"A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus",COMPLETED,,PHASE2,61.0,ACTUAL,Incyte Corporation,,2.0,,,t,,,,f,t,f,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,NCT03147742,APPROVED_FOR_MARKETING,,,,2023,1.0
NCT05945147,,2023-06-26,,,2024-02-20,2023-07-11,2023-07-14,ACTUAL,,,,,,,2024-02-20,2024-02-22,ACTUAL,2024-01-01,ESTIMATED,2024-01-01,2024-02,2024-02-29,2024-05-31,ESTIMATED,2024-05-31,2024-04-30,ESTIMATED,2024-04-30,,INTERVENTIONAL,,,Ketamine and Midazolam Infusions for CRPS: Feasibility Study,Feasibility Study Comparing a Ketamine and Midazolam Infusion to a Midazolam-Only Infusion for Complex Regional Pain Syndrome,WITHDRAWN,,PHASE2,0.0,ACTUAL,Stanford University,,2.0,,Lack of funding,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,OTHER,,,,,,,2024,0.0
NCT05505539,,2022-06-06,,,2022-09-20,2022-08-15,2022-08-17,ACTUAL,,,,,,,2022-09-20,2022-09-22,ACTUAL,2022-09-30,ESTIMATED,2022-09-30,2022-09,2022-09-30,2023-12-31,ESTIMATED,2023-12-31,2023-08-31,ESTIMATED,2023-08-31,,INTERVENTIONAL,OL_5FU,,Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia,Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia: a Pilot Study,WITHDRAWN,,PHASE1,0.0,ACTUAL,"University of California, San Francisco",,1.0,,Principal Investigator no longer with university.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 10:15:59.39815,2024-10-16 10:15:59.39815,OTHER,,,,,,,2023,0.0
NCT03945227,,2019-04-24,,,2020-10-14,2019-05-07,2019-05-10,ACTUAL,,,,,,,2020-10-14,2020-10-19,ACTUAL,2019-06,ESTIMATED,2019-06-30,2020-10,2020-10-31,2022-01,ESTIMATED,2022-01-31,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,,,Clinical Trial for Evaluating Efficacy and Safety of PDR001 in Concurrent Plus Consolidation Versus Consolidation Only in Addition to Standard Chemoradiotherapy in Unresectable Stage III NSCLC Patients (PASTURE),A Phase II Clinical Trial for Evaluating Efficacy and Safety of PDR001 in Concurrent Plus Consolidation Versus Consolidation Only in Addition to Standard Chemoradiotherapy in Unresectable Stage III NSCLC Patients (PASTURE),WITHDRAWN,,PHASE2,0.0,ACTUAL,Yonsei University,,2.0,,"Due to the delay in the study shceduled, due to the start of competitive study and the approval of Durvalumab from the Ministry of Food and Drug Safety, it was judged that it was difficult to enroll subjects.",f,,,,f,f,f,,,,,,,,,,,2024-10-16 21:11:55.969063,2024-10-16 21:11:55.969063,OTHER,,,,,,,2022,0.0
NCT04513652,,2020-08-09,2022-08-04,,2022-08-30,2020-08-11,2020-08-14,ACTUAL,2022-08-30,2022-09-28,ACTUAL,,,,2022-08-30,2022-09-28,ACTUAL,2020-09-03,ACTUAL,2020-09-03,2022-08,2022-08-31,2020-12-17,ACTUAL,2020-12-17,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,,,A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution,"A Randomized, Double-Masked, Vehicle-Controlled, Parallel Evaluation of the Local Anesthetic Effect of Articaine Sterile Topical Ophthalmic Solution",COMPLETED,,PHASE3,120.0,ACTUAL,"American Genomics, LLC",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:28:31.109149,2024-10-16 00:28:31.109149,INDUSTRY,,,,,,,2020,1.0
NCT03807479,,2018-11-07,,,2023-09-12,2019-01-14,2019-01-17,ACTUAL,,,,,,,2023-09-12,2023-09-14,ACTUAL,2018-12-11,ACTUAL,2018-12-11,2022-09,2022-09-30,2023-08-31,ACTUAL,2023-08-31,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,PONS,,Study in Patients With Chronic Leukemia,Phase 2 Clinical Trial With Ponatinib as a Second Line Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Prior First Line Tyrosine Kinase Inhibitor Treatment,TERMINATED,,PHASE2,18.0,ACTUAL,GWT-TUD GmbH,,1.0,,less recruting,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,OTHER,,,,,,,2023,0.0
NCT02787044,,2016-05-25,2021-05-24,,2021-12-22,2016-05-31,2016-06-01,ESTIMATED,2021-08-18,2021-09-14,ACTUAL,,,,2021-12-22,2022-01-21,ACTUAL,2016-08-01,ACTUAL,2016-08-01,2021-12,2021-12-31,2020-05-31,ACTUAL,2020-05-31,2020-05-31,ACTUAL,2020-05-31,,INTERVENTIONAL,INVESTED,,INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure,INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure,COMPLETED,,PHASE4,5388.0,ACTUAL,Brigham and Women's Hospital,,2.0,,,f,,,,t,,,,,,,,"Data will be available as per NIH guidelines on December 4, 2022 (2 years from the primary study publication date).",Data will be available to all qualified researchers based on the NIH BIOLINCC criteria.,https://biolincc.nhlbi.nih.gov/home/,YES,Data will be shared according to NIH data sharing rules,2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,OTHER,,,,,,,2020,1.0
NCT03566303,,2018-06-08,,,2020-05-13,2018-06-21,2018-06-25,ACTUAL,,,,,,,2020-05-13,2020-05-15,ACTUAL,2018-07-10,ACTUAL,2018-07-10,2020-05,2020-05-31,2020-04-26,ACTUAL,2020-04-26,2020-04-26,ACTUAL,2020-04-26,,INTERVENTIONAL,RIWA,,Rivaroxaban vs Warfarin in Patients With Metallic Prosthesis,Rivaroxaban vs Warfarin in Patients With Metallic Prosthesis,TERMINATED,,PHASE2/PHASE3,50.0,ACTUAL,Hospital Geral Roberto Santos,,2.0,,Coronavirus Pandemic,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,OTHER,,,,,,,2020,0.0
NCT04002115,,2019-06-24,2023-08-09,,2023-09-07,2019-06-26,2019-06-28,ACTUAL,2023-09-07,2023-09-14,ACTUAL,,,,2023-09-07,2023-09-14,ACTUAL,2020-06-03,ACTUAL,2020-06-03,2023-09,2023-09-30,2022-11-07,ACTUAL,2022-11-07,2022-08-30,ACTUAL,2022-08-30,,INTERVENTIONAL,,,Clofarabine Pre-conditioning Followed by Stem Cell Transplant for Non-remission AML,Clofarabine Pre-conditioning Followed by Hematopoietic Stem Cell Transplant With Post-Transplant Cyclophosphamide for Non-remission Acute Myeloid Leukemia,TERMINATED,,PHASE2,2.0,ACTUAL,Milton S. Hershey Medical Center,"Due to slow accrual, the study was terminated.",1.0,,terminated due to low accrual,f,,,,t,t,f,,,,,,,,,NO,At this time there is no plan to share IPD with other researchers outside of Penn State University,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,OTHER,,,,,,,2022,0.0
NCT04479436,,2020-07-13,,2023-01-10,2023-01-10,2020-07-19,2020-07-21,ACTUAL,,,,2023-01-10,2023-01-13,ACTUAL,2023-01-10,2023-01-13,ACTUAL,2020-09-14,ACTUAL,2020-09-14,2023-01,2023-01-31,2022-02-03,ACTUAL,2022-02-03,2022-02-03,ACTUAL,2022-02-03,,INTERVENTIONAL,,,A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer,"A Multi-Center, Open-Label, Phase 2 Study to Evaluate Safety and Efficacy of U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer (CRC)",TERMINATED,,PHASE2,40.0,ACTUAL,Daiichi Sankyo,,2.0,,Study was terminated early given the Interim Analysis for Part 1 (signal finding) did not meet pre-specified criteria and will not proceed to Part 2. Sponsor will proceed closing the study.,f,,,,f,t,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,INDUSTRY,,,,,,,2022,0.0
NCT01490502,,2011-12-06,2022-05-13,,2022-09-12,2011-12-12,2011-12-13,ESTIMATED,2022-09-12,2022-09-28,ACTUAL,,,,2022-09-12,2022-09-28,ACTUAL,2012-03,ACTUAL,2012-03-31,2022-09,2022-09-30,2021-05-15,ACTUAL,2021-05-15,2021-05-15,ACTUAL,2021-05-15,,INTERVENTIONAL,,,Vitamin D Supplementation in Multiple Sclerosis,A Randomized Controlled Trial of Vitamin D Supplementation in Multiple Sclerosis,COMPLETED,,PHASE3,172.0,ACTUAL,Johns Hopkins University,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,OTHER,,,,,,,2021,1.0
NCT03304054,,2017-09-28,2021-04-13,,2024-03-07,2017-10-02,2017-10-06,ACTUAL,2021-07-21,2021-08-13,ACTUAL,,,,2024-03-07,2024-03-12,ACTUAL,2018-04-18,ACTUAL,2018-04-18,2021-07,2021-07-31,2020-03-15,ACTUAL,2020-03-15,2020-01-31,ACTUAL,2020-01-31,,INTERVENTIONAL,,"The analysis of baseline characteristics included all patients in the Safety population, who are those patients who enrolled and received at least one dose of amifampridine. Patients who began the run-in period belong to the Safety population whether they were randomized to treatment or not.",Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG,"A Randomized, Placebo-control, Parallel Group Study to Evaluate the Effect of Amifampridine Phosphate in Patients With MuSK Antibody Positive Myasthenia Gravis, and a Sample of AChR Antibody Positive Myasthenia Gravis Patients",COMPLETED,,PHASE3,93.0,ACTUAL,"Catalyst Pharmaceuticals, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,INDUSTRY,,,,,,,2020,1.0
NCT02075047,,2014-02-27,2021-02-01,,2021-06-15,2014-02-27,2014-03-03,ESTIMATED,2021-03-29,2021-04-01,ACTUAL,,,,2021-06-15,2021-06-16,ACTUAL,2014-05-23,ACTUAL,2014-05-23,2021-06,2021-06-30,2020-05-18,ACTUAL,2020-05-18,2020-04-11,ACTUAL,2020-04-11,,INTERVENTIONAL,,The safety analysis set included all participants who were randomized and took at least 1 dose of study medication (ziprasidone or placebo).,Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder,"A PHASE 3, MULTICENTER, FOUR-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP EFFICACY AND SAFETY TRIAL OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (CURRENT OR MOST RECENT EPISODE MANIC)",TERMINATED,,PHASE3,171.0,ACTUAL,Pfizer,,2.0,,"Based on recent input from FDA, the pre-specified final analysis will be performed at the current enrollment using a re-estimation of the sample size.",f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,INDUSTRY,,,,,,,2020,0.0
NCT02596555,,2015-11-03,,,2020-02-12,2015-11-03,2015-11-04,ESTIMATED,,,,,,,2020-02-12,2020-02-17,ACTUAL,2016-01,ACTUAL,2016-01-31,2020-02,2020-02-29,2020-02,ACTUAL,2020-02-29,2020-02,ACTUAL,2020-02-29,,INTERVENTIONAL,PEITHO-2,,Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for Acute Intermediate-Risk Pulmonary Embolism.,Safety and Efficacy of Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for the Treatment of Acute Intermediate-Risk Pulmonary Embolism,TERMINATED,,PHASE4,400.0,ACTUAL,Johannes Gutenberg University Mainz,,1.0,,1. Interim results suggested a reduction of sample size.~2. Anticipated length of enrolment period with resulting funding issues to pose a threat to the study.,f,,,,t,,,,,,,,,,,,,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,OTHER,,,,,,,2020,0.0
NCT03690739,,2018-09-26,,,2022-02-08,2018-09-27,2018-10-01,ACTUAL,,,,,,,2022-02-08,2022-02-24,ACTUAL,2019-08-09,ACTUAL,2019-08-09,2022-02,2022-02-28,2021-03-03,ACTUAL,2021-03-03,2021-03-03,ACTUAL,2021-03-03,,INTERVENTIONAL,,,Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer,Trabectedin/PLD Versus Continuation of Platinum-based Chemo-therapy in Patients With Disease Stabilization and no Symptom Benefit Under Platinum-based Chemotherapy for Recurrent Ovarian Cancer,TERMINATED,,PHASE3,9.0,ACTUAL,AGO Research GmbH,,2.0,,Insufficient Recruitment,f,,,,t,f,f,,,,,,,,,,,2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,INDUSTRY,,,,,,,2021,0.0
NCT05388279,,2022-05-10,,,2023-03-20,2022-05-19,2022-05-24,ACTUAL,,,,,,,2023-03-20,2023-03-23,ACTUAL,2022-04-28,ACTUAL,2022-04-28,2023-03,2023-03-31,2022-09-19,ACTUAL,2022-09-19,2022-09-19,ACTUAL,2022-09-19,,INTERVENTIONAL,,,A Clinical Study to Evaluate the Safety and Tolerability of JS012 in Advanced or Metastatic Solid Tumors,"A Phase I Clinical Study Evaluating the Safety ,Tolerability, Pharmacokinetics of JS012 in Patients With Advanced or Metastatic Solid Tumors",TERMINATED,,PHASE1,3.0,ACTUAL,"Shanghai Junshi Bioscience Co., Ltd.",,2.0,,"Due to the adjustment and change of the sponsor's R\&D strategy, we now plan to voluntarily terminate this clinical trial.",f,,,,t,f,f,,,,,,,,,,,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,OTHER,,,,,,,2022,0.0
NCT05864391,,2023-04-20,,,2024-05-08,2023-05-16,2023-05-18,ACTUAL,,,,,,,2024-05-08,2024-05-10,ACTUAL,2023-03-31,ACTUAL,2023-03-31,2024-05,2024-05-31,2024-03-20,ACTUAL,2024-03-20,2024-03-20,ACTUAL,2024-03-20,,INTERVENTIONAL,,,"A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD7503 in Participants With Suspected NASH.","A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7503 Following Multiple Ascending Dose Administration to Patients With Suspected Non-cirrhotic Non-alcoholic Steatohepatitis (NASH)",TERMINATED,,PHASE1,40.0,ACTUAL,AstraZeneca,,3.0,,AstraZeneca have decided to not move forward with the development of the compound.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,INDUSTRY,,,,,,,2024,0.0
NCT00515554,,2007-08-10,,,2020-11-11,2007-08-10,2007-08-13,ESTIMATED,,,,,,,2020-11-11,2020-11-13,ACTUAL,2008-05,ACTUAL,2008-05-31,2020-11,2020-11-30,2020-07,ACTUAL,2020-07-31,2019-07,ACTUAL,2019-07-31,,INTERVENTIONAL,,,HD18 for Advanced Stages in Hodgkins Lymphoma,,COMPLETED,,PHASE3,1500.0,ACTUAL,University of Cologne,,4.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,OTHER,,,,,,,2020,0.0
NCT04096820,,2019-09-18,2023-11-14,,2024-05-29,2019-09-18,2019-09-20,ACTUAL,2024-05-29,2024-05-30,ACTUAL,,,,2024-05-29,2024-05-30,ACTUAL,2019-09-06,ACTUAL,2019-09-06,2024-05,2024-05-31,2023-01-01,ACTUAL,2023-01-01,2022-10-31,ACTUAL,2022-10-31,,INTERVENTIONAL,,The study was terminated because of Covid related delay and problems with enrollment as well as cost considerations (funds ran out).,Uromune in Treating Recurrent Urinary Tract Infections in Women,"Protocol 19-01: Canadian, Single Centre, Pilot, Open Label Study to Evaluate the Efficacy and Safety of the Bacterial Vaccine Uromune in Treating Recurrent Urinary Tract Infections in Women.",TERMINATED,,PHASE2,67.0,ACTUAL,Queen's University,,1.0,,Convenience sample based on available funding. Increased Covid-related costs of clinical research resulted in early termination,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,OTHER,,,,,,,2023,0.0
NCT01602861,,2012-05-17,,,2021-09-08,2012-05-18,2012-05-21,ESTIMATED,,,,,,,2021-09-08,2021-09-09,ACTUAL,2013-02,,2013-02-28,2021-09,2021-09-30,2021-04,ACTUAL,2021-04-30,2021-04,ACTUAL,2021-04-30,,INTERVENTIONAL,SPIREN,,The Effects of Spironolactone on Calcineurin Inhibitor Induced Nephrotoxicity,The Effects of Spironolactone on Calcineurin Inhibitor Induced Nephrotoxicity,COMPLETED,,PHASE4,188.0,ACTUAL,Odense University Hospital,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,OTHER,,,,,,,2021,0.0
NCT02947165,,2016-10-18,,,2022-01-28,2016-10-25,2016-10-27,ESTIMATED,,,,,,,2022-01-28,2022-01-31,ACTUAL,2017-04-25,ACTUAL,2017-04-25,2022-01,2022-01-31,2021-06-18,ACTUAL,2021-06-18,2021-06-18,ACTUAL,2021-06-18,,INTERVENTIONAL,,,Phase I/Ib Study of NIS793 in Combination With PDR001 in Patients With Advanced Malignancies.,"A Phase I/Ib, Open-label, Multi-center Dose Escalation Study of NIS793 in Combination With PDR001 in Adult Patients With Advanced Malignancies",COMPLETED,,PHASE1,120.0,ACTUAL,Novartis,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,INDUSTRY,,,,,,,2021,1.0
NCT02721654,,2016-03-15,,,2023-08-06,2016-03-22,2016-03-29,ESTIMATED,,,,,,,2023-08-06,2023-08-08,ACTUAL,2017-09-01,ACTUAL,2017-09-01,2023-08,2023-08-31,2021-06-30,ACTUAL,2021-06-30,2021-03-30,ACTUAL,2021-03-30,,INTERVENTIONAL,PLUS,,Plasma-Lyte 148® versUs Saline Study,Comparison of Plasmalyte 148® and Saline for Fluid Resuscitation and Intravenous Fluid Therapy in Critically Ill Adults,COMPLETED,,PHASE4,5037.0,ACTUAL,The George Institute,,2.0,,,f,,,,t,f,f,,,,,,,,,YES,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,OTHER,,,,,,,2021,1.0
NCT05466240,,2022-06-21,2024-01-16,,2024-02-07,2022-07-18,2022-07-20,ACTUAL,2024-02-07,2024-03-05,ACTUAL,,,,2024-02-07,2024-03-05,ACTUAL,2022-04-29,ACTUAL,2022-04-29,2024-02,2024-02-29,2023-01-19,ACTUAL,2023-01-19,2023-01-19,ACTUAL,2023-01-19,,INTERVENTIONAL,,,Study of AT-752 in Patients With Dengue Infection,"A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of AT-752 in Patients With Dengue Infection",TERMINATED,,PHASE2,21.0,ACTUAL,"Atea Pharmaceuticals, Inc.",Early discontinuation leading to small numbers of subjects analyzed.,3.0,,Sponsor decision to deprioritize the dengue program,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,INDUSTRY,,,,,,,2023,0.0
NCT02054806,,2014-02-03,2022-04-19,,2023-02-06,2014-02-03,2014-02-04,ESTIMATED,2023-02-06,2023-10-30,ACTUAL,,,,2023-02-06,2023-10-30,ACTUAL,2014-02-17,ACTUAL,2014-02-17,2023-02,2023-02-28,2021-04-30,ACTUAL,2021-04-30,2021-04-30,ACTUAL,2021-04-30,,INTERVENTIONAL,,"The analysis population consisted of all allocated participants who received at least one dose of study drug. Per protocol, Baseline Characteristics were summarized by treatment dose.",Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28),Phase IB Study of Pembrolizumab (MK-3475) in Subjects With Select Advanced Solid Tumors,COMPLETED,,PHASE1,477.0,ACTUAL,Merck Sharp & Dohme LLC,,1.0,,,f,,,,f,,,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,INDUSTRY,,,,,,,2021,1.0
NCT02569801,,2015-10-06,2021-02-05,,2021-04-21,2015-10-06,2015-10-07,ESTIMATED,2021-04-21,2021-04-23,ACTUAL,,,,2021-04-21,2021-04-23,ACTUAL,2015-12-04,ACTUAL,2015-12-04,2021-04,2021-04-30,2020-02-28,ACTUAL,2020-02-28,2020-02-28,ACTUAL,2020-02-28,,INTERVENTIONAL,HydranGea,,A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy,"A Phase II, Open-Label, Randomized Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic ER+ /HER2- Breast Cancer Resistant to Aromatase Inhibitor Therapy",TERMINATED,,PHASE2,71.0,ACTUAL,"Genentech, Inc.",,2.0,,"The Sponsor decided to halt the development of GDC-0810, but not due to any safety concerns.",f,,,,,t,f,,,,,,,,,,,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,INDUSTRY,,,,,,,2020,0.0
NCT05180500,,2021-12-17,2023-11-28,,2024-04-01,2021-12-17,2022-01-06,ACTUAL,2023-12-14,2024-01-05,ACTUAL,,,,2024-04-01,2024-04-23,ACTUAL,2022-03-15,ACTUAL,2022-03-15,2024-04,2024-04-30,2022-12-07,ACTUAL,2022-12-07,2022-12-07,ACTUAL,2022-12-07,,INTERVENTIONAL,,All randomized participants,Safety and Acceptability of Q GRFT Nasal Spray for COVID-19 Prophylaxis,Phase 1 Clinical Trial of a Q GRFT Nasal Spray,COMPLETED,,PHASE1,50.0,ACTUAL,University of Pittsburgh,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,OTHER,,,,,,,2022,1.0
NCT04939987,,2021-06-01,,,2022-08-31,2021-06-17,2021-06-25,ACTUAL,,,,,,,2022-08-31,2022-09-06,ACTUAL,2022-08,ESTIMATED,2022-08-31,2022-05,2022-05-31,2022-10,ESTIMATED,2022-10-31,2022-10,ESTIMATED,2022-10-31,,INTERVENTIONAL,,,Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy,Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy: A Randomized Controlled Trial,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,PI left institution and study was not transferred to new PI,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,OTHER,,,,,,,2022,0.0
NCT02773849,,2016-04-19,2022-05-11,2020-05-11,2024-07-26,2016-05-12,2016-05-16,ESTIMATED,2022-06-17,2022-07-13,ACTUAL,2020-05-11,2020-05-13,ACTUAL,2024-07-26,2024-07-29,ACTUAL,2016-09-19,ACTUAL,2016-09-19,2024-07,2024-07-31,2023-05-24,ACTUAL,2023-05-24,2019-05-24,ACTUAL,2019-05-24,,INTERVENTIONAL,,,"ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)","A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN® (rAd-IFN)/Syn3) Administered Intravesically to Patients With High-Grade, BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)",COMPLETED,,PHASE3,157.0,ACTUAL,Ferring Pharmaceuticals,,1.0,,,f,,,,t,t,,,,,,,,,,NO,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,INDUSTRY,,,,,,,2023,1.0
NCT03777436,,2018-12-14,2022-10-21,,2024-05-10,2018-12-14,2018-12-17,ACTUAL,2022-11-17,2022-12-15,ACTUAL,,,,2024-05-10,2024-05-14,ACTUAL,2019-02-11,ACTUAL,2019-02-11,2024-05,2024-05-31,2022-02-09,ACTUAL,2022-02-09,2021-09-23,ACTUAL,2021-09-23,,INTERVENTIONAL,DISCREET,The intent-to-treat (ITT) analysis set consisted of all participants who are randomized regardless of whether the participant received investigational product (IP).,An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis,"A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double Blind-Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis",COMPLETED,,PHASE3,289.0,ACTUAL,Amgen,,2.0,,,t,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,INDUSTRY,,NCT03740516,NO_LONGER_AVAILABLE,,,,2022,1.0
NCT03523715,,2018-05-01,2021-03-11,,2021-03-11,2018-05-01,2018-05-14,ACTUAL,2021-03-11,2021-04-08,ACTUAL,,,,2021-03-11,2021-04-08,ACTUAL,2017-11-30,ACTUAL,2017-11-30,2021-03,2021-03-31,2020-07-31,ACTUAL,2020-07-31,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,Prunes for Gastrointestinal Function After Gynecologic Surgery,Effect of Prunes on Gastrointestinal Function After Gynecological Surgery: A Randomized Controlled Trial,TERMINATED,,PHASE4,77.0,ACTUAL,University of Southern California,,2.0,,Difficulty in recruiting participants,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,OTHER,,,,,,,2020,0.0
NCT05454709,,2022-05-06,,,2023-12-29,2022-07-07,2022-07-12,ACTUAL,,,,,,,2023-12-29,2024-01-03,ACTUAL,2023-12-29,ESTIMATED,2023-12-29,2023-12,2023-12-31,2023-12-29,ESTIMATED,2023-12-29,2023-12-29,ESTIMATED,2023-12-29,,INTERVENTIONAL,STABLE-1,,A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System,A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System; a Feasibility Study,WITHDRAWN,,PHASE2,0.0,ACTUAL,Inreda Diabetic B.V.,,2.0,,Study medication could not be delivered by manufacturer.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,INDUSTRY,,,,,,,2023,0.0
NCT02907177,,2016-08-25,2021-03-24,,2021-04-27,2016-09-15,2016-09-20,ESTIMATED,2021-04-27,2021-05-18,ACTUAL,,,,2021-04-27,2021-05-18,ACTUAL,2017-03-30,ACTUAL,2017-03-30,2021-04,2021-04-30,2020-03-26,ACTUAL,2020-03-26,2020-03-26,ACTUAL,2020-03-26,,INTERVENTIONAL,POINT,Randomized Analysis Set included all participants who were randomized in this study.,Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®),"Multicenter, Randomized, Double-blind, Parallel-group, add-on, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)",TERMINATED,,PHASE3,136.0,ACTUAL,Actelion,"Due to slow recruitment rate the study was considered futile by the Independent Data Monitoring Committee and the sponsor agreed to prematurely terminate the study. Due to this premature termination of study, the insufficient sample size did not allow to detect the differences for the main efficacy endpoints. The safety profile of ponesimod as add-on to DMF therapy could not be fully characterized due to limited data.",2.0,,sponsor decision due to low recruitment,f,,,,t,t,f,,,,,,,,,,,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,INDUSTRY,,,,,,,2020,0.0
NCT02807636,,2016-06-17,2023-08-22,,2024-04-23,2016-06-20,2016-06-21,ESTIMATED,2023-12-11,2023-12-13,ACTUAL,,,,2024-04-23,2024-04-29,ACTUAL,2016-06-30,ACTUAL,2016-06-30,2024-04,2024-04-30,2024-02-12,ACTUAL,2024-02-12,2022-08-31,ACTUAL,2022-08-31,,INTERVENTIONAL,IMvigor130,,Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma,"A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) as Monotherapy and in Combination With Platinum-Based Chemotherapy in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma",COMPLETED,,PHASE3,1213.0,ACTUAL,Hoffmann-La Roche,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,INDUSTRY,,,,,,,2024,1.0
NCT04221256,,2020-01-06,,,2021-07-19,2020-01-07,2020-01-09,ACTUAL,,,,,,,2021-07-19,2021-07-23,ACTUAL,2020-03-11,ACTUAL,2020-03-11,2021-07,2021-07-31,2021-02-09,ACTUAL,2021-02-09,2021-02-09,ACTUAL,2021-02-09,,INTERVENTIONAL,,,Dose-finding Study of Selective Serotonin Reuptake Inhibitors to Enhance Neuroplasticity,Dose-finding Study of Selective Serotonin Reuptake Inhibitors to Enhance Neuroplasticity,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Burke Medical Research Institute,,2.0,,Closure due to COVID-19 pandemic,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,OTHER,,,,,,,2021,0.0
NCT03496519,,2018-03-23,,,2018-10-04,2018-04-05,2018-04-12,ACTUAL,,,,,,,2018-10-04,2018-10-09,ACTUAL,2018-10-01,ESTIMATED,2018-10-01,2018-10,2018-10-31,2021-10-31,ESTIMATED,2021-10-31,2021-10-31,ESTIMATED,2021-10-31,,INTERVENTIONAL,,,Assessing the Combination of Durvalumab (MEDI4736) and Trabectedin in Solid Tumors,A Phase I Study Assessing the Combination of Durvalumab (MEDI4736) and Trabectedin in Solid Tumors,WITHDRAWN,,PHASE1,0.0,ACTUAL,"University of Colorado, Denver",,2.0,,Contract Issues,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,OTHER,,,,,,,2021,0.0
NCT03285087,,2017-09-14,,,2021-01-12,2017-09-14,2017-09-15,ACTUAL,,,,,,,2021-01-12,2021-01-14,ACTUAL,2021-06,ESTIMATED,2021-06-30,2021-01,2021-01-31,2022-08,ESTIMATED,2022-08-31,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,DEXSEDATION,,Risk Prediction of Dexmedetomidine-associated Hemodynamic Instability,Risk Prediction and Consequences of Dexmedetomidine-associated Hemodynamic Instability in Intubated Mechanically Ventilated Intensive Care Unit Patients,SUSPENDED,,PHASE2/PHASE3,250.0,ESTIMATED,Assiut University,,1.0,,dexmedetomidine is unavailable in this time,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,OTHER,,,,,,,2022,0.0
NCT04735432,,2021-01-26,2022-11-22,,2023-01-31,2021-02-01,2021-02-03,ACTUAL,2023-01-31,2023-02-28,ACTUAL,,,,2023-01-31,2023-02-28,ACTUAL,2021-02-05,ACTUAL,2021-02-05,2023-01,2023-01-31,2021-12-13,ACTUAL,2021-12-13,2021-11-02,ACTUAL,2021-11-02,,INTERVENTIONAL,ADAPTsc,ITT analysis set: All randomized participants who were exposed to the IMP. mITT analysis set: All randomized participants with a value for total IgG levels at baseline and at least 1 postbaseline time point. Safety analysis set: All randomized participants who were exposed to IMP. PK analysis set: A subset of the safety analysis set with at least 1 post dose PK measurement.,Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis,"A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC With Multiple Intravenous Infusions of Efgartigimod in Patients With Generalized Myasthenia Gravis",COMPLETED,,PHASE3,110.0,ACTUAL,argenx,None reported.,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,INDUSTRY,,,,,,,2021,1.0
NCT00982111,,2009-09-18,2015-12-21,2010-09-14,2021-12-12,2009-09-21,2009-09-22,ESTIMATED,2016-05-20,2016-06-27,ESTIMATED,2010-09-14,2010-09-16,ESTIMATED,2021-12-12,2022-01-11,ACTUAL,2009-11-02,ACTUAL,2009-11-02,2021-12,2021-12-31,2020-12-23,ACTUAL,2020-12-23,2012-11-14,ACTUAL,2012-11-14,,INTERVENTIONAL,INSPIRE,,First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin,"A Randomized, Multicenter, Open-Label Phase 3 Study of Pemetrexed-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Pemetrexed-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer (NSCLC)",COMPLETED,,PHASE3,633.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,,,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and assigned data sharing agreement.,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,INDUSTRY,,,,,,,2020,1.0
NCT04938180,,2021-06-16,2023-04-17,,2024-05-22,2021-06-22,2021-06-24,ACTUAL,2024-05-22,2024-05-24,ACTUAL,,,,2024-05-22,2024-05-24,ACTUAL,2021-09-16,ACTUAL,2021-09-16,2024-05,2024-05-31,2022-05-17,ACTUAL,2022-05-17,2022-04-20,ACTUAL,2022-04-20,,INTERVENTIONAL,,"A total of 48 subjects were planned. However, enrollment into the study was stopped in November 2021 after 4 subjects were enrolled to focus more on AMB-05X intra-articular administration.",A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients,"A Phase 2, Adaptive, Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Intravenous AMB-05X in Subjects With Tenosynovial Giant Cell Tumor",TERMINATED,,PHASE2,4.0,ACTUAL,"AmMax Bio, Inc.","A decision was made in November 2021 to stop further enrollment into the study to allow development to focus on AMB-05X intra-articular administration for TGCT. A total of 4 subjects had been enrolled into the study at the time the decision to cease further enrollment was made, limiting the ability to interpret the resulting data.",1.0,,"Further enrollment was halted in November 2021, enrolled subjects completed the study. Sponsor stopped further recruitment in this intravenous study to focus on intra-articular route of administration in subjects with tenosynovial giant cell tumor.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,INDUSTRY,,,,,,,2022,0.0
NCT03785067,,2018-12-06,,,2021-03-29,2018-12-19,2018-12-24,ACTUAL,,,,,,,2021-03-29,2021-04-01,ACTUAL,2020-02-27,ACTUAL,2020-02-27,2021-03,2021-03-31,2021-02-03,ACTUAL,2021-02-03,2021-02-03,ACTUAL,2021-02-03,,INTERVENTIONAL,TRIDENT COG,,Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Cognitive Sub-Study,Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Cognitive Sub-Study,TERMINATED,,PHASE3,1.0,ACTUAL,The George Institute,,2.0,,Contractual and financial issues.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,OTHER,,,,,,,2021,0.0
NCT03225105,,2017-07-19,2022-01-27,,2023-02-09,2017-07-19,2017-07-21,ACTUAL,2023-02-09,2023-11-22,ACTUAL,,,,2023-02-09,2023-11-22,ACTUAL,2017-09-06,ACTUAL,2017-09-06,2023-01,2023-01-31,2020-04-27,ACTUAL,2020-04-27,2019-09-02,ACTUAL,2019-09-02,,INTERVENTIONAL,,Safety analysis set included all participants who received at least 1 dose of M3541.,M3541 in Combination With Radiotherapy in Solid Tumors,"A Phase I, Open-label, Uncontrolled, Multicenter, Dose-escalation Study of M3541 in Combination With Palliative Radiotherapy in Subjects With Solid Tumors",TERMINATED,,PHASE1,15.0,ACTUAL,EMD Serono,The study was terminated early per sponsor decision to halt further development of M3541 due to pharmaceutical and PK/pharmacodynamics properties that precluded further clinical development.,4.0,,The study was terminated early per sponsor decision to halt further development of M3541 due to pharmaceutical and PK/pharmacodynamics properties that precluded further clinical development.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,INDUSTRY,,,,,,,2020,0.0
NCT04741204,,2021-01-28,,,2023-07-05,2021-02-02,2021-02-05,ACTUAL,,,,,,,2023-07-05,2023-07-06,ACTUAL,2022-09,ESTIMATED,2022-09-30,2023-07,2023-07-31,2022-09,ESTIMATED,2022-09-30,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,METBC,,Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer,Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer Response to Neoadjuvant Treatment,WITHDRAWN,,PHASE4,0.0,ACTUAL,Woman's,,2.0,,Limited staff to carry out study,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,OTHER,,,,,,,2022,0.0
NCT04123067,,2019-10-08,2022-07-29,,2022-08-23,2019-10-09,2019-10-10,ACTUAL,2022-08-23,2022-09-15,ACTUAL,,,,2022-08-23,2022-09-15,ACTUAL,2020-09-01,ACTUAL,2020-09-01,2022-08,2022-08-31,2021-04-07,ACTUAL,2021-04-07,2021-04-07,ACTUAL,2021-04-07,,INTERVENTIONAL,,Pioglitazone Group contains 0 participants because the Responsible Party terminated the study following the enrollment of first study subject,Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke,Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke: Effects on the Stress-Immune Response,TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,Milton S. Hershey Medical Center,Study was terminated early due to lack of funding and Responsible Party relocating to another institution,2.0,,Temporarily suspended due to Pandemic.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,OTHER,,,,,,,2021,0.0
NCT04867226,,2021-04-25,,,2021-06-19,2021-04-28,2021-04-30,ACTUAL,,,,,,,2021-06-19,2021-06-22,ACTUAL,2021-05-08,ACTUAL,2021-05-08,2021-06,2021-06-30,2021-06-18,ACTUAL,2021-06-18,2021-06-18,ACTUAL,2021-06-18,,INTERVENTIONAL,,,Effectiveness of Colchicine Among Patients With COVID-19 Infection,Effectiveness of Colchicine Among Patients With COVID-19 Infection,COMPLETED,,PHASE2,100.0,ACTUAL,Hawler Medical University,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,OTHER,,,,,,,2021,0.0
NCT04552899,,2020-09-14,2024-02-02,,2024-03-21,2020-09-16,2020-09-17,ACTUAL,2024-03-21,2024-04-18,ACTUAL,,,,2024-03-21,2024-04-18,ACTUAL,2021-03-19,ACTUAL,2021-03-19,2024-03,2024-03-31,2023-02-10,ACTUAL,2023-02-10,2023-02-10,ACTUAL,2023-02-10,,INTERVENTIONAL,STARSCAPE,The randomized population included all randomized participants.,A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis,"A Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis",TERMINATED,,PHASE3,665.0,ACTUAL,Hoffmann-La Roche,This study was terminated early based on the futility analysis which concluded that zinpentraxin alfa was unlikely to meet its primary endpoint.,2.0,,The study was terminated by Sponsor as the futility analysis outcome indicated that the study was unlikely to meet the predefined primary objective of the study. No new safety concerns were identified.,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).~For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,INDUSTRY,,,,,,,2023,0.0
NCT02708849,,2016-03-09,2020-04-27,,2020-06-18,2016-03-09,2016-03-15,ESTIMATED,2020-06-18,2020-07-02,ACTUAL,,,,2020-06-18,2020-07-02,ACTUAL,2015-06,,2015-06-30,2020-06,2020-06-30,2020-03,ACTUAL,2020-03-31,2020-03,ACTUAL,2020-03-31,,INTERVENTIONAL,,,The Sustained Effects of Ketamine,The Sustained Effects of Ketamine,TERMINATED,,PHASE1,3.0,ACTUAL,Yale University,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,OTHER,,,,,,,2020,0.0
NCT04652102,,2020-12-01,2022-12-09,,2023-11-20,2020-12-01,2020-12-03,ACTUAL,2023-11-20,2024-04-29,ACTUAL,,,,2023-11-20,2024-04-29,ACTUAL,2020-12-11,ACTUAL,2020-12-11,2023-11,2023-11-30,2022-06-10,ACTUAL,2022-06-10,2022-06-10,ACTUAL,2022-06-10,,INTERVENTIONAL,,Safety Analysis Set: Included all participants randomized into Phase 2b or 3 who received at least one dose of CVnCoV or placebo.,"A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older","COVID-19: A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older",COMPLETED,,PHASE2/PHASE3,39680.0,ACTUAL,CureVac,,5.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,INDUSTRY,,,,,,,2022,1.0
NCT03484962,,2018-03-26,,,2020-10-13,2018-03-26,2018-04-02,ACTUAL,,,,,,,2020-10-13,2020-10-19,ACTUAL,2018-03-25,ACTUAL,2018-03-25,2020-05,2020-05-31,2020-08-25,ACTUAL,2020-08-25,2020-05-25,ACTUAL,2020-05-25,,INTERVENTIONAL,,,Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Liver Cancer,Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Liver Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Fuda Cancer Hospital, Guangzhou",,3.0,,No participants enrolled,f,,,,t,f,f,,,,,,,,,,,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,OTHER,,,,,,,2020,0.0
NCT04814368,,2021-03-22,,,2024-08-09,2021-03-22,2021-03-24,ACTUAL,,,,,,,2024-08-09,2024-08-13,ACTUAL,2021-08-27,ACTUAL,2021-08-27,2024-08,2024-08-31,2024-06-24,ACTUAL,2024-06-24,2024-06-24,ACTUAL,2024-06-24,,INTERVENTIONAL,,,A Safety and Efficacy Study of Anti-inflammatory (Canakinumab) and Cartilage Stimulating (LNA043) Drugs Injected Into the Knee Joint of Participants With Knee Osteoarthritis (OA),"A Randomized, Four-arm, Canakinumab Placebo-controlled, Participant, Investigator and Sponsor-blinded Study Investigating the Safety, Tolerability and Efficacy of Intra-articular Canakinumab Followed by Intra-articular LNA043 in Patients With Knee Osteoarthritis",TERMINATED,,PHASE2,23.0,ACTUAL,Novartis,,4.0,,Sponsor Decision,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the study in line with applicable laws and regulations.~This study data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,INDUSTRY,,,,,,,2024,0.0
NCT02586025,,2015-10-23,2018-10-22,,2023-04-26,2015-10-23,2015-10-26,ESTIMATED,2018-12-10,2019-01-03,ACTUAL,,,,2023-04-26,2023-05-22,ACTUAL,2016-03-14,ACTUAL,2016-03-14,2023-04,2023-04-30,2022-03-14,ACTUAL,2022-03-14,2017-10-23,ACTUAL,2017-10-23,,INTERVENTIONAL,PEONY,Intent-to-Treat (ITT) population included all participants who were enrolled regardless of whether they received any study treatment.,Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer to Evaluate Treatment With Trastuzumab Plus (+) Pertuzumab + Docetaxel Compared With Trastuzumab + Placebo + Docetaxel,"A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate Pertuzumab in Combination With Docetaxel and Trastuzumab as Neoadjuvant Therapy, and Pertuzumab in Combination With Trastuzumab as Adjuvant Therapy After Surgery and Chemotherapy in Patients With Early-Stage or Locally Advanced HER2-Positive Breast Cancer",COMPLETED,,PHASE3,329.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,t,f,,,t,,,,,,,,2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,INDUSTRY,,,,,,,2022,1.0
NCT03960008,,2019-04-30,2024-04-04,,2024-08-02,2019-05-21,2019-05-22,ACTUAL,2024-08-02,2024-08-28,ACTUAL,,,,2024-08-02,2024-08-28,ACTUAL,2020-03-01,ACTUAL,2020-03-01,2024-08,2024-08-31,2024-02-28,ACTUAL,2024-02-28,2024-02-28,ACTUAL,2024-02-28,,INTERVENTIONAL,SBRTvsTACE,,Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant,A Randomized Multi-Center Phase III Study of Individualized Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as a Bridge to Transplant in Hepatocellular Carcinoma.,TERMINATED,,PHASE3,9.0,ACTUAL,Lahey Clinic,"This study closed to accrual early, with the limited number of participants, we were unable to analyze the data.",2.0,,This study was closed early due to lack of enrollments and insufficient funding.,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,OTHER,,,,,,,2024,0.0
NCT04540874,,2020-09-04,2022-09-26,,2022-09-26,2020-09-04,2020-09-07,ACTUAL,2022-09-26,2023-08-16,ACTUAL,,,,2022-09-26,2023-08-16,ACTUAL,2020-10-05,ACTUAL,2020-10-05,2022-09,2022-09-30,2020-11-12,ACTUAL,2020-11-12,2020-11-12,ACTUAL,2020-11-12,,INTERVENTIONAL,,Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of investigational medicinal product. The treatment assignment will be determined based on the first treatment the subjects received.,A Study in Healthy Japanese Men to Test How Different Doses of BI 894416 Are Tolerated,"Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 894416 Versus Placebo in Healthy Male Japanese Subjects (Single-blind, Randomized, Placebo-controlled Within Dose Group)",TERMINATED,,PHASE1,8.0,ACTUAL,Boehringer Ingelheim,"The study was terminated by the sponsor after the first dosage group (25 mg BI 894416), only a subset of the analyses planned in the protocol was performed. No dose-proportionality analysis was done. Secondary endpoints were analysed descriptively only.",2.0,,due to company decision,f,,,,f,f,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: http://trials.boehringer-ingelheim.com/",2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,INDUSTRY,,,,,,,2020,0.0
NCT03662074,,2018-09-05,2021-08-18,,2023-07-26,2018-09-05,2018-09-07,ACTUAL,2021-10-15,2021-11-12,ACTUAL,,,,2023-07-26,2023-08-02,ACTUAL,2018-11-07,ACTUAL,2018-11-07,2023-07,2023-07-31,2022-02-03,ACTUAL,2022-02-03,2020-10-07,ACTUAL,2020-10-07,,INTERVENTIONAL,,,Subsequent Line Gemcitabine and Nivolumab in Treating Participants With Metastatic Small Cell Lung Cancer,Phase II Pilot Study of Subsequent Line Gemcitabine and Nivolumab for Advanced SCLC,TERMINATED,,PHASE2,14.0,ACTUAL,Wake Forest University Health Sciences,,1.0,,After interim analysis decided not to move forward with continuing the trial.,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,OTHER,,,,,,,2022,0.0
NCT03822091,,2019-01-28,,,2023-05-07,2019-01-28,2019-01-30,ACTUAL,,,,,,,2023-05-07,2023-05-09,ACTUAL,2019-01-28,ACTUAL,2019-01-28,2023-05,2023-05-31,2020-01-30,ACTUAL,2020-01-30,2020-01-30,ACTUAL,2020-01-30,,INTERVENTIONAL,,,Terlipressin Infusion Alone Vs Terlipressin With Noradrenaline Infusion In The Treatment of Hepatorenal Syndrome Type 1,Comparison of The Effectiveness of Terlipressin Infusion Alone Vs Terlipressin With Noradrenaline Infusion In The Treatment of Hepatorenal Syndrome Type 1,COMPLETED,,PHASE3,60.0,ACTUAL,PGIMER,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,UNKNOWN,,,,,,,2020,0.0
NCT04782245,,2021-03-01,,,2023-08-03,2021-03-03,2021-03-04,ACTUAL,,,,,,,2023-08-03,2023-08-07,ACTUAL,2022-09,ESTIMATED,2022-09-30,2023-08,2023-08-31,2024-04,ESTIMATED,2024-04-30,2024-04,ESTIMATED,2024-04-30,,INTERVENTIONAL,ARCADIA-HF,,Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List,"Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List: a Multicenter, Double-blind, Randomized Clinical Trial.",WITHDRAWN,,PHASE2,0.0,ACTUAL,Hospices Civils de Lyon,,2.0,,New recommandations,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,OTHER,,,,,,,2024,0.0
NCT05013385,,2021-08-13,2023-05-30,,2023-05-30,2021-08-13,2021-08-19,ACTUAL,2023-05-30,2023-06-26,ACTUAL,,,,2023-05-30,2023-06-26,ACTUAL,2021-11-09,ACTUAL,2021-11-09,2023-05,2023-05-31,2022-05-31,ACTUAL,2022-05-31,2022-05-31,ACTUAL,2022-05-31,,INTERVENTIONAL,,Enrolled patients: Fibrostenotic Crohn's Disease patients who were eligible to enter the Lead-In period of the trial.,A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction,"Multi-center, Double-blind, Randomized, Placebo-controlled, Phase IIa Trial to Evaluate Spesolimab (BI 655130) Efficacy in Patients With Fibrostenotic Crohn's Disease",TERMINATED,,PHASE2,5.0,ACTUAL,Boehringer Ingelheim,,2.0,,Sponsor decision,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,INDUSTRY,,,,,,,2022,0.0
NCT03871348,,2019-01-24,,,2024-03-01,2019-03-10,2019-03-12,ACTUAL,,,,,,,2024-03-01,2024-03-05,ACTUAL,2019-01-03,ACTUAL,2019-01-03,2024-03,2024-03-31,2024-02-21,ACTUAL,2024-02-21,2022-07-25,ACTUAL,2022-07-25,,INTERVENTIONAL,,,A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors,"A Phase 1 First-in-Human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR441000 Administered Intratumorally as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1,77.0,ACTUAL,Sanofi,,6.0,,Sponsor terminated the study for non-safety reasons,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,INDUSTRY,,,,,,,2024,0.0
NCT04840199,,2021-04-07,,,2024-01-10,2021-04-07,2021-04-09,ACTUAL,,,,,,,2024-01-10,2024-01-11,ACTUAL,2022-11-02,ACTUAL,2022-11-02,2023-04,2023-04-30,2023-11-30,ACTUAL,2023-11-30,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,ELICIT,,"A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes.","Randomized, Controlled Trial to Evaluate the Anti-inflammatory Efficacy of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive ART and Its Effect on Chronic Inflammation, HIV Persistence, and Other Clinical Outcomes",COMPLETED,,PHASE2,44.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,t,t,f,,,,,,Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.,* With whom?~  * Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses?~  * To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism with data be made available?~  * Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at: https://submit.mis.s-3.net/. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.,https://submit.mis.s-3.net/,YES,"Individual participant data that underlie results in the publication, after de-identification.",2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,NIH,,,,,,,2023,0.0
NCT04472000,,2020-07-10,,,2024-06-13,2020-07-10,2020-07-15,ACTUAL,,,,,,,2024-06-13,2024-06-14,ACTUAL,2021-04-27,ACTUAL,2021-04-27,2024-06,2024-06-30,2024-04-21,ACTUAL,2024-04-21,2023-05-16,ACTUAL,2023-05-16,,INTERVENTIONAL,VitC,,Can Vitamin C Reduce the Risk of Postoperative Shoulder Stiffness?,"Can Vitamin C Reduce the Risk of Postoperative Shoulder Stiffness? A Multi-center, Double-blinded, Randomized and Placebo-controlled Study",TERMINATED,,PHASE4,46.0,ACTUAL,Lindenhofgruppe AG,,2.0,,The study had to be stopped due to difficulties in recruiting patients.,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,INDUSTRY,,,,,,,2024,0.0
NCT04027348,,2019-07-18,2022-09-21,,2022-11-09,2019-07-18,2019-07-22,ACTUAL,2022-11-09,2022-11-29,ACTUAL,,,,2022-11-09,2022-11-29,ACTUAL,2019-06-26,ACTUAL,2019-06-26,2022-09,2022-09-30,2021-09-03,ACTUAL,2021-09-03,2021-09-03,ACTUAL,2021-09-03,,INTERVENTIONAL,,,Palliative Management of Inoperable Malignant Bowel Obstruction,"Palliative Management of Inoperable Malignant Bowel Obstruction: A Prospective, Open Label, Phase-2 Study at an NCI Comprehensive Cancer Center",TERMINATED,,PHASE2,15.0,ACTUAL,Roswell Park Cancer Institute,,1.0,,low accrual,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,OTHER,,,,,,,2021,0.0
NCT02546440,,2015-09-06,,,2023-03-28,2015-09-09,2015-09-10,ESTIMATED,,,,,,,2023-03-28,2023-03-31,ACTUAL,2015-09,ACTUAL,2015-09-30,2023-03,2023-03-31,2022-09,ACTUAL,2022-09-30,2021-09,ACTUAL,2021-09-30,,INTERVENTIONAL,DMF-CTCL,,Study on Therapy With Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL),Phase IIA Study on Therapy With the NF-κB Inhibiting and Apoptosis Inducing Drug Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL),COMPLETED,,PHASE2,25.0,ACTUAL,Universitätsmedizin Mannheim,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,OTHER,,,,,,,2022,1.0
NCT02401074,,2015-03-24,,,2020-12-05,2015-03-26,2015-03-27,ESTIMATED,,,,,,,2020-12-05,2020-12-09,ACTUAL,2018-11-08,ACTUAL,2018-11-08,2020-11,2020-11-30,2020-06,ESTIMATED,2020-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,RATE,,Airway Temperature,Role of Airway Tissue Temperature in Asthma Exacerbation,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Kentucky,,1.0,,"Study was withdrawn prior to patient enrollment due to COVID-19, funding termination and lack of eligible study participants.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:06:57.733473,2024-10-15 14:06:57.733473,OTHER,,,,,,,2020,0.0
NCT04503668,,2020-08-03,,,2024-06-06,2020-08-03,2020-08-07,ACTUAL,,,,,,,2024-06-06,2024-06-10,ACTUAL,2020-12-28,ACTUAL,2020-12-28,2024-06,2024-06-30,2024-03-11,ACTUAL,2024-03-11,2024-01-03,ACTUAL,2024-01-03,,INTERVENTIONAL,,,Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients,Phase III Randomized Control Trial Investigating Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients With Gynecologic Malignancies Receiving Every 3-week Carboplatin and Paclitaxel Chemotherapy,TERMINATED,,PHASE3,62.0,ACTUAL,University of Michigan Rogel Cancer Center,,2.0,,Lack of Patient Population,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,OTHER,,,,,,,2024,0.0
NCT04390113,,2020-05-12,2024-04-18,,2024-04-18,2020-05-12,2020-05-15,ACTUAL,2024-04-18,2024-05-14,ACTUAL,,,,2024-04-18,2024-05-14,ACTUAL,2021-03-18,ACTUAL,2021-03-18,2024-04,2024-04-30,2024-01-30,ACTUAL,2024-01-30,2024-01-30,ACTUAL,2024-01-30,,INTERVENTIONAL,,,Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC),"Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant (HCT)",TERMINATED,,PHASE3,97.0,ACTUAL,AlloVir,AlloVir decided to discontinue the trial on 22-Dec-2023 following a pre-planned DSMB futility analysis concluding the study was unlikely to meet its primary endpoint; no safety concerns were identified.,2.0,,Study discontinued as DSMB determined it was futile. No safety concerns were noted.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,INDUSTRY,,,,,,,2024,0.0
NCT01737827,,2012-11-12,2024-03-25,,2024-09-18,2012-11-29,2012-11-30,ESTIMATED,2024-09-18,2024-09-24,ACTUAL,,,,2024-09-18,2024-09-24,ACTUAL,2013-03-25,ACTUAL,2013-03-25,2024-09,2024-09-30,2023-05-24,ACTUAL,2023-05-24,2023-04-24,ACTUAL,2023-04-24,,INTERVENTIONAL,,,Study Efficacy and Safety of INC280 in Patients With Advanced Hepatocellular Carcinoma.,"A Phase II, Open Label, Single Arm, Multicenter Study of INC280 Administered Orally in Adults With Advanced Hepatocellular Carcinoma",TERMINATED,,PHASE2,38.0,ACTUAL,Novartis,,1.0,,The study recruitment was ended due to difficulties in identifying subjects who meet the eligibility criteria and therefore the study never reached its planned sample size per protocol. The study termination was not due to any safety concerns.,f,,,,f,,,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,INDUSTRY,,,,,,,2023,0.0
NCT04737187,,2021-01-29,2023-10-17,2023-07-12,2024-08-30,2021-02-02,2021-02-03,ACTUAL,2023-12-05,2023-12-26,ACTUAL,,2023-12-26,ACTUAL,2024-08-30,2024-09-24,ACTUAL,2020-11-25,ACTUAL,2020-11-25,2024-08,2024-08-31,2023-09-12,ACTUAL,2023-09-12,2022-07-19,ACTUAL,2022-07-19,,INTERVENTIONAL,SUNLIGHT,Full Analysis Set (FAS): all participants to whom a therapeutic unit was randomly assigned using Interactive Web Response System (IWRS). Participants were analyzed in the arm they were assigned by randomization.,Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients,"An Open-label, Randomized, Phase III Study Comparing Trifluridine/Tipiracil in Combination With Bevacizumab to Trifluridine/Tipiracil Monotherapy in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT Study)",COMPLETED,,PHASE3,492.0,ACTUAL,"Taiho Oncology, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,INDUSTRY,,,,,,,2023,1.0
NCT04409223,,2020-05-27,,,2024-02-07,2020-05-29,2020-06-01,ACTUAL,,,,,,,2024-02-07,2024-02-09,ACTUAL,2020-09-12,ACTUAL,2020-09-12,2024-02,2024-02-29,2022-03-25,ACTUAL,2022-03-25,2022-03-25,ACTUAL,2022-03-25,,INTERVENTIONAL,,,Efficacy and Safety of Famitinib Versus Sunitinib in the Treatment of Advanced Gastrointestinal Stromal Tumour Patients After Failure of Imatinib,"A Phase III, Open Label, Randomised，Controlled, Multi-centre Study to Assess the Efficacy and Safety of Famitinib Versus Sunitinib in the Treatment of Advanced Gastrointestinal Stromal Tumour Patients After Failure of Imatinib",TERMINATED,,PHASE3,185.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,2.0,,R\&D strategy adjustment,f,,,,,f,f,,,,,,,,,,,2024-10-16 21:18:15.643917,2024-10-16 21:18:15.643917,INDUSTRY,,,,,,,2022,0.0
NCT03929744,,2019-04-25,,,2020-11-17,2019-04-25,2019-04-29,ACTUAL,,,,,,,2020-11-17,2020-11-18,ACTUAL,2019-06-12,ACTUAL,2019-06-12,2020-11,2020-11-30,2020-11-02,ACTUAL,2020-11-02,2020-11-02,ACTUAL,2020-11-02,,INTERVENTIONAL,,,A Study of LY3502970 in Healthy Participants,"A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Healthy Subjects",COMPLETED,,PHASE1,133.0,ACTUAL,Eli Lilly and Company,,9.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,INDUSTRY,,,,,,,2020,1.0
NCT04209114,,2019-12-20,2024-06-05,,2024-06-05,2019-12-20,2019-12-23,ACTUAL,2024-06-05,2024-06-27,ACTUAL,,,,2024-06-05,2024-06-27,ACTUAL,2020-02-05,ACTUAL,2020-02-05,2024-06,2024-06-30,2023-06-07,ACTUAL,2023-06-07,2023-06-07,ACTUAL,2023-06-07,,INTERVENTIONAL,,,"A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer","A Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus Bempegaldesleukin (NKTR-214), Versus Nivolumab Alone Versus Standard of Care in Participants With Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible",COMPLETED,,PHASE3,114.0,ACTUAL,Bristol-Myers Squibb,"BMS and Nektar Therapeutics jointly decided to terminate the clinical development program for bempegaldesleukin (NKTR-214) in combination with nivolumab. Discontinued survival follow-up and the stopping of submission of local labs to vendors, imaging to the BICR vendor, and PROs have resulted in confounded and incomplete trial results.",3.0,,,f,,,,t,t,f,,,,,,,,,YES,"Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html",2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,INDUSTRY,,,,,,,2023,0.0
NCT05330689,,2022-04-09,,,2024-03-24,2022-04-09,2022-04-15,ACTUAL,,,,,,,2024-03-24,2024-03-26,ACTUAL,2022-03-06,ACTUAL,2022-03-06,2024-03,2024-03-31,2022-09-07,ACTUAL,2022-09-07,2022-09-07,ACTUAL,2022-09-07,,INTERVENTIONAL,,,How Does Platelet Dose Impact Clinical Outcomes After PRP Treatment?,How Does Platelet Dose Impact Clinical Outcomes After PRP Treatment?,WITHDRAWN,,PHASE2,0.0,ACTUAL,Vanderbilt University Medical Center,,5.0,,Funding for study equipment,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,OTHER,,,,,,,2022,0.0
NCT03228836,,2017-07-22,2020-11-18,,2020-12-20,2017-07-22,2017-07-25,ACTUAL,2020-11-18,2020-12-17,ACTUAL,,,,2020-12-20,2021-01-12,ACTUAL,2017-08-23,ACTUAL,2017-08-23,2020-12,2020-12-31,2020-02-28,ACTUAL,2020-02-28,2020-02-28,ACTUAL,2020-02-28,,INTERVENTIONAL,ORIENT-4,,Efficacy and Safety Evaluation of IBI308 in Patients With Extranodal NK/T Cell Lymphoma Patients,"Efficacy and Safety Evaluation of IBI308 in Patients With Relapsed/Refractory Extranodal NK/T Cell Lymphoma, Nasal Type: a Multicenter, Single Arm, Phase 2 Study (ORIENT-4)",COMPLETED,,PHASE2,28.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,INDUSTRY,,,,,,,2020,1.0
NCT04691141,,2020-12-23,,,2024-04-15,2020-12-29,2020-12-31,ACTUAL,,,,,,,2024-04-15,2024-04-17,ACTUAL,2021-02-23,ACTUAL,2021-02-23,2024-03,2024-03-31,2023-09-19,ACTUAL,2023-09-19,2023-09-19,ACTUAL,2023-09-19,,INTERVENTIONAL,HATCH,,"A Study to Evaluating the Pharmacokinetics, Safety, and Efficacy of ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome (MDS)","A Phase I/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome (MDS) Patients After Failure of Hypomethylating Agent (HMA)-Based Therapy",TERMINATED,,PHASE1/PHASE2,15.0,ACTUAL,Antengene Corporation,,1.0,,The study was stopped early because the sponsor decided to change the study-drug development strategy,f,,,,,f,f,,,,,,,,,,,2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,INDUSTRY,,,,,,,2023,0.0
NCT03420781,,2018-01-24,2021-10-05,,2021-11-24,2018-02-01,2018-02-05,ACTUAL,2021-11-24,2021-12-22,ACTUAL,,,,2021-11-24,2021-12-22,ACTUAL,2018-01-24,ACTUAL,2018-01-24,2021-11,2021-11-30,2020-10-30,ACTUAL,2020-10-30,2020-10-30,ACTUAL,2020-10-30,,INTERVENTIONAL,,ITT Population included all participants who entered the 40-week treatment period.,A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03,"A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis",TERMINATED,,PHASE3,467.0,ACTUAL,Allergan,,5.0,,The Relamorelin program is being terminated solely based on a business decision.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 14:13:07.075647,2024-10-15 14:13:07.075647,INDUSTRY,,,,,,,2020,0.0
NCT03345160,,2017-11-06,2021-09-29,,2021-10-27,2017-11-13,2017-11-17,ACTUAL,2021-10-27,2021-10-29,ACTUAL,,,,2021-10-27,2021-10-29,ACTUAL,2018-04-27,ACTUAL,2018-04-27,2021-10,2021-10-31,2020-10-07,ACTUAL,2020-10-07,2020-10-07,ACTUAL,2020-10-07,,INTERVENTIONAL,,,Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study,Open Label Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study,COMPLETED,,PHASE2,7.0,ACTUAL,Johns Hopkins University,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,Data will not be shared,2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,OTHER,,,,,,,2020,1.0
NCT03206918,,2017-06-29,2020-08-10,,2021-09-29,2017-06-29,2017-07-02,ACTUAL,2020-09-04,2020-09-25,ACTUAL,,,,2021-09-29,2021-10-04,ACTUAL,2017-03-09,ACTUAL,2017-03-09,2021-09,2021-09-30,2020-09-10,ACTUAL,2020-09-10,2018-06-15,ACTUAL,2018-06-15,,INTERVENTIONAL,,Safety Analysis Set: All participants who received any dose of study drug.,Efficacy and Safety of Zanubrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma,"A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Safety and Efficacy of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)",COMPLETED,,PHASE2,91.0,ACTUAL,BeiGene,,1.0,,,f,,,,t,f,f,,,,,,,,,YES,,2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,INDUSTRY,,,,,,,2020,1.0
NCT03828747,,2019-01-29,2022-07-15,,2024-08-29,2019-01-31,2019-02-04,ACTUAL,2022-09-01,2022-10-03,ACTUAL,,,,2024-08-29,2024-09-24,ACTUAL,2019-01-25,ACTUAL,2019-01-25,2024-08,2024-08-31,2023-08-30,ACTUAL,2023-08-30,2021-07-20,ACTUAL,2021-07-20,,INTERVENTIONAL,,,A Study of Semorinemab in Patients With Moderate Alzheimer's Disease,"A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Moderate Alzheimer's Disease",COMPLETED,,PHASE2,272.0,ACTUAL,"Genentech, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)",2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,INDUSTRY,,,,,,,2023,1.0
NCT03641248,,2018-08-16,,,2022-05-19,2018-08-16,2018-08-21,ACTUAL,,,,,,,2022-05-19,2022-05-26,ACTUAL,2021-05-01,ESTIMATED,2021-05-01,2022-05,2022-05-31,2021-08-31,ESTIMATED,2021-08-31,2021-07-31,ESTIMATED,2021-07-31,,INTERVENTIONAL,,,Bioavailability and Pharmacokinetic Measures of H. Procumbens Extract,Study to Establish the Bioavailability and Pharmacokinetic Measures of H. Procumbens Extract in Humans,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Missouri-Columbia,,2.0,,Recruitment was not possible due to COVID19.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:12:34.283115,2024-10-15 00:12:34.283115,OTHER,,,,,,,2021,0.0
NCT05246280,,2021-12-16,,,2024-07-23,2022-02-08,2022-02-18,ACTUAL,,,,,,,2024-07-23,2024-07-25,ACTUAL,2022-03-02,ACTUAL,2022-03-02,2024-07,2024-07-31,2024-07-09,ACTUAL,2024-07-09,2024-07-09,ACTUAL,2024-07-09,,INTERVENTIONAL,,,Tc 99m Tilmanocept Imaging for Early Prediction of Anti-TNFα Therapy Response in Moderate to Severe Active RA,Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFα Therapy Response in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA),TERMINATED,,PHASE3,196.0,ACTUAL,Navidea Biopharmaceuticals,,1.0,,Sponsor Decision,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,INDUSTRY,,,,,,,2024,0.0
NCT03758170,,2018-11-16,,,2022-03-09,2018-11-28,2018-11-29,ACTUAL,,,,,,,2022-03-09,2022-03-10,ACTUAL,2019-01-29,ACTUAL,2019-01-29,2022-03,2022-03-31,2022-02-01,ACTUAL,2022-02-01,2022-02-01,ACTUAL,2022-02-01,,INTERVENTIONAL,,,High-Dose Steroid for Knee Arthroplasty,High-Dose Steroid for Total Knee Arthroplasty - A Randomized Doubleblinded Controlled Trial,COMPLETED,,PHASE4,160.0,ACTUAL,"Copenhagen University Hospital, Hvidovre",,2.0,,,f,,,,t,f,f,,,,,,"From 1 year after last included patient, and onto 4 years after end of trial.",Upon reasonable request to the corresponding author,,YES,Data will be available upon reasonable request,2024-10-15 14:13:07.075647,2024-10-15 14:13:07.075647,OTHER,,,,,,,2022,0.0
NCT03866538,,2019-02-27,2022-08-03,,2022-08-03,2019-03-06,2019-03-07,ACTUAL,2022-08-03,2022-08-26,ACTUAL,,,,2022-08-03,2022-08-26,ACTUAL,2019-09-10,ACTUAL,2019-09-10,2022-08,2022-08-31,2021-10-19,ACTUAL,2021-10-19,2021-10-19,ACTUAL,2021-10-19,,INTERVENTIONAL,,Study was terminated due to recruitment being difficult and not achieved,Budesonide in Patients With Immune Mediated Enteropathies,Open-label Withdrawal Trial of Budesonide in Patients With Immune Mediated Enteropathies,TERMINATED,,PHASE4,1.0,ACTUAL,Mayo Clinic,Study was terminated due to recruitment being difficult and not achieved.,2.0,,Study recruitment was difficult and not acheived,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,OTHER,,,,,,,2021,0.0
NCT03121677,,2017-04-17,,,2023-08-09,2017-04-17,2017-04-20,ACTUAL,,,,,,,2023-08-09,2023-08-14,ACTUAL,2018-10-16,ACTUAL,2018-10-16,2023-08,2023-08-31,2023-08-07,ACTUAL,2023-08-07,2020-09-24,ACTUAL,2020-09-24,,INTERVENTIONAL,,,Personalized Tumor Vaccine Strategy and PD-1 Blockade in Patients With Follicular Lymphoma,Pilot Study of a Personalized Tumor Vaccine Strategy and PD-1 Blockade in Patients With Follicular Lymphoma,TERMINATED,,PHASE1,4.0,ACTUAL,Washington University School of Medicine,,1.0,,Vaccine manufacturing has been suspended,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,OTHER,,,,,,,2023,0.0
NCT02933073,,2016-09-20,,,2022-11-01,2016-10-11,2016-10-14,ESTIMATED,,,,,,,2022-11-01,2022-11-07,ACTUAL,2016-11,,2016-11-30,2022-11,2022-11-30,2022-08,ACTUAL,2022-08-31,2022-08,ACTUAL,2022-08-31,,INTERVENTIONAL,,,Study of Oncoimmunome for the Treatment of Stage III/IV Ovarian Carcinoma,A Phase I Study of Oncoimmunome for the Treatment of Stage III/IV Ovarian Carcinoma,TERMINATED,,PHASE1,8.0,ACTUAL,UConn Health,,1.0,,Study recruitment is temporary on hold by the sponsor due to patient recruitment challenges and the ongoing review of the investigational adjuvant.,f,,,,t,,,,,,,,,,,NO,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,OTHER,,,,,,,2022,0.0
NCT04829799,,2021-03-31,,,2022-06-09,2021-03-31,2021-04-02,ACTUAL,,,,,,,2022-06-09,2022-06-13,ACTUAL,2022-02,ESTIMATED,2022-02-28,2022-06,2022-06-30,2023-08,ESTIMATED,2023-08-31,2023-08,ESTIMATED,2023-08-31,,INTERVENTIONAL,,,Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain,Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Florida,,2.0,,"Per study team, the study will not proceed",f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,OTHER,,,,,,,2023,0.0
NCT04021017,,2019-07-12,,,2022-12-14,2019-07-12,2019-07-16,ACTUAL,,,,,,,2022-12-14,2022-12-16,ACTUAL,2020-01-21,ACTUAL,2020-01-21,2022-12,2022-12-31,2022-12-13,ACTUAL,2022-12-13,2022-12-13,ACTUAL,2022-12-13,,INTERVENTIONAL,PRE-GAiN,,PRE-GAiN Bone Health Pilot Study,PRE-GAIN Bone Health Pilot Study - Physiologic Replacement of EstroGen for Adolescent Females With AnorexIa Nervosa for Bone Health Pilot Study,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Saskatchewan,,2.0,,PI Workload,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 14:13:07.075647,2024-10-15 14:13:07.075647,OTHER,,,,,,,2022,0.0
NCT03685253,,2018-09-21,,,2022-03-24,2018-09-24,2018-09-26,ACTUAL,,,,,,,2022-03-24,2022-04-05,ACTUAL,2019-01-24,ACTUAL,2019-01-24,2022-03,2022-03-31,2024-10-01,ESTIMATED,2024-10-01,2022-10-01,ESTIMATED,2022-10-01,,INTERVENTIONAL,NiRiD,,Nicotinamide Riboside for Diabetic Neuropathy,Nicotinamide Riboside in Diabetic Polyneuropathy,SUSPENDED,,PHASE1/PHASE2,54.0,ESTIMATED,"University of Maryland, Baltimore",,2.0,,pilot component of study completed,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:24:29.407204,2024-10-16 21:24:29.407204,OTHER,,,,,,,2024,0.0
NCT02802163,,2016-06-13,,,2017-04-24,2016-06-13,2016-06-16,ESTIMATED,,,,,,,2017-04-24,2017-04-25,ACTUAL,2017-06,ESTIMATED,2017-06-30,2017-04,2017-04-30,2020-12,ESTIMATED,2020-12-31,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,"Induction Therapy for Multiple Myeloma With Carfilzomib, Lenalidomide,Dexamethasone,Panobinostat","Phase I-II Study of Carfilzomib, Lenalidomide, Dexamethasone, and Panobinostat, Ca-R-Pa-Diem, as Induction Therapy for Newly Diagnosed, Untreated, Transplant-Eligible, Multiple Myeloma Patients",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,1.0,,study drug unavailable,f,,,,f,t,f,,,,,,,,,,,2024-10-15 14:13:07.075647,2024-10-15 14:13:07.075647,OTHER,,,,,,,2020,0.0
NCT04458311,,2020-06-11,,,2024-04-23,2020-06-30,2020-07-07,ACTUAL,,,,,,,2024-04-23,2024-04-25,ACTUAL,2020-12-01,ACTUAL,2020-12-01,2024-04,2024-04-30,2023-11-15,ACTUAL,2023-11-15,2023-04-01,ACTUAL,2023-04-01,,INTERVENTIONAL,ACTIon,,Abiraterone Acetate in Combination With Tildrakizumab,ACTION: Phase I/II Trial of Abiraterone Acetate in Combination With Tildrakizumab (Anti-IL23 Targeting Monoclonal Antibody) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC),TERMINATED,,PHASE1/PHASE2,13.0,ACTUAL,"Institute of Cancer Research, United Kingdom",,2.0,,Funder decided that response outcomes to date did not support continuation of the study.,f,,,,,t,f,,,t,,,,,,,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,OTHER,,,,,,,2023,0.0
NCT05486195,,2022-08-02,,,2022-08-02,2022-08-02,2022-08-03,ACTUAL,,,,,,,2022-08-02,2022-08-03,ACTUAL,2019-03-14,ACTUAL,2019-03-14,2022-08,2022-08-31,2020-03-11,ACTUAL,2020-03-11,2019-07-29,ACTUAL,2019-07-29,,INTERVENTIONAL,,,A Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects Including an Assessment of Receptor Occupancy and Food Effect,"A First-in-Human, Randomized, Placebo-controlled, Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects Including Receptor Occupancy Measurements After Single Dose of SDI-118 and an Assessment of Food Effect",COMPLETED,,PHASE1,32.0,ACTUAL,AbbVie,,7.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 21:24:29.407204,2024-10-16 21:24:29.407204,INDUSTRY,,,,,,,2020,1.0
NCT02655523,,2016-01-12,,,2022-06-17,2016-01-13,2016-01-14,ESTIMATED,,,,,,,2022-06-17,2022-06-23,ACTUAL,2015-12,,2015-12-31,2022-06,2022-06-30,2022-06,ACTUAL,2022-06-30,2022-06,ACTUAL,2022-06-30,,INTERVENTIONAL,,,A Comparison of Dexamethasone and Triamcinolone for Ultrasound-guided Occipital C2 Nerve Blocks,A Comparison of Dexamethasone and Triamcinolone in Combination With Bupivacaine for Ultrasound-guided Occipital C2 Nerve Blocks: A Randomized Controlled Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,Northwestern University,,3.0,,lack of recruitment,f,,,,f,,,,,,,,,,,NO,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,OTHER,,,,,,,2022,0.0
NCT03711929,,2018-10-17,2023-08-24,,2023-11-08,2018-10-17,2018-10-19,ACTUAL,2023-11-08,2023-12-04,ACTUAL,,,,2023-11-08,2023-12-04,ACTUAL,2018-11-19,ACTUAL,2018-11-19,2023-11,2023-11-30,2022-06-14,ACTUAL,2022-06-14,2022-06-14,ACTUAL,2022-06-14,,INTERVENTIONAL,,,"LUMINA Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye","LUMINA: A Phase III, Multicenter, Sham-Controlled, Randomized, Double-Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye.",TERMINATED,,PHASE3,145.0,ACTUAL,Santen Inc.,,4.0,,Business decision,f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,INDUSTRY,,,,,,,2022,0.0
NCT04347902,,2020-04-13,,,2020-04-15,2020-04-13,2020-04-15,ACTUAL,,,,,,,2020-04-15,2020-04-17,ACTUAL,2016-01,ACTUAL,2016-01-31,2020-04,2020-04-30,2020-04,ACTUAL,2020-04-30,2020-03,ACTUAL,2020-03-31,,INTERVENTIONAL,5ylipids,,Lipid Emulsions and Liver Function - Results After 5 Years.,Intravenous Lipid Emulsions and Liver Function in Adult Chronic Intestinal Failure Patients: New Results After 5 Years.,COMPLETED,,PHASE4,65.0,ACTUAL,Stanley Dudrick's Memorial Hospital,,3.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,OTHER,,,,,,,2020,1.0
NCT02425891,,2015-04-21,2021-03-24,,2022-06-28,2015-04-21,2015-04-24,ESTIMATED,2021-04-23,2021-05-17,ACTUAL,,,,2022-06-28,2022-07-19,ACTUAL,2015-06-23,ACTUAL,2015-06-23,2022-06,2022-06-30,2021-08-31,ACTUAL,2021-08-31,2020-04-14,ACTUAL,2020-04-14,,INTERVENTIONAL,,,A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130),"A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer",COMPLETED,,PHASE3,902.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,INDUSTRY,,,,,,,2021,1.0
NCT03968159,,2019-05-13,2021-05-21,,2021-10-19,2019-05-29,2019-05-30,ACTUAL,2021-10-19,2021-11-17,ACTUAL,,,,2021-10-19,2021-11-17,ACTUAL,2019-04-25,ACTUAL,2019-04-25,2021-10,2021-10-31,2020-05-29,ACTUAL,2020-05-29,2020-04-30,ACTUAL,2020-04-30,,INTERVENTIONAL,,,Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment,"Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment (ACP-103-054/059)",COMPLETED,,PHASE3,298.0,ACTUAL,ACADIA Pharmaceuticals Inc.,"In March 2020, recruitment of new patients was paused due to the emerging coronavirus disease 2019 (COVID-19) pandemic. At that point in time, about half of the planned patients had been randomized. The Sponsor decided to combine this trial with the identically designed trial ACP-103-054, with a prespecified combined statistical analysis plan. As a result, both trials were closed and proceeded with database lock and statistical analysis of the combined data. No further patients were enrolled.",2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,INDUSTRY,,,,,,,2020,1.0
NCT03032614,,2017-01-23,,,2017-10-06,2017-01-23,2017-01-26,ESTIMATED,,,,,,,2017-10-06,2017-10-10,ACTUAL,2017-09-30,ESTIMATED,2017-09-30,2017-08,2017-08-31,2020-04-30,ESTIMATED,2020-04-30,2019-03-31,ESTIMATED,2019-03-31,,INTERVENTIONAL,,,"Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients","Phase II Clinical Trial on the Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients With Homologous Recombination Deficiency",WITHDRAWN,,PHASE2,0.0,ACTUAL,The University of Texas Health Science Center at San Antonio,,1.0,,Lack of funding,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,OTHER,,,,,,,2020,0.0
NCT03202667,,2017-06-27,,,2021-12-10,2017-06-27,2017-06-28,ACTUAL,,,,,,,2021-12-10,2021-12-13,ACTUAL,2017-12-15,ACTUAL,2017-12-15,2021-12,2021-12-31,2021-12-06,ACTUAL,2021-12-06,2021-08-26,ACTUAL,2021-08-26,,INTERVENTIONAL,SANDx,,Effects of the SGLT2-inhibitor Empagliflozin on Patients With Chronic SIADH - the SANDx Study,Effects of the SGLT2-inhibitor Empagliflozin on Patients With Chronic SIADH - the SANDx Study,COMPLETED,,PHASE2/PHASE3,17.0,ACTUAL,"University Hospital, Basel, Switzerland",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,OTHER,,,,,,,2021,1.0
NCT04366739,,2020-04-24,,,2024-07-09,2020-04-28,2020-04-29,ACTUAL,,,,,,,2024-07-09,2024-07-10,ACTUAL,2020-04-29,ESTIMATED,2020-04-29,2020-04,2020-04-30,2020-09-30,ESTIMATED,2020-09-30,2020-08-30,ESTIMATED,2020-08-30,,INTERVENTIONAL,reCoVery,,Repurposing of Chlorpromazine in Covid-19 Treatment,Repurposing of Chlorpromazine in Covid-19 Treatment,WITHDRAWN,,PHASE3,0.0,ACTUAL,Centre Hospitalier St Anne,,2.0,,No favourable opinion obtained from the Ethics Committee,f,,,,t,f,f,,,,,,,,,,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,OTHER,,,,,,,2020,0.0
NCT04493684,,2020-07-20,2022-08-29,,2023-08-20,2020-07-29,2020-07-30,ACTUAL,2023-08-20,2023-08-23,ACTUAL,,,,2023-08-20,2023-08-23,ACTUAL,2020-07-31,ACTUAL,2020-07-31,2023-08,2023-08-31,2021-08-30,ACTUAL,2021-08-30,2021-08-30,ACTUAL,2021-08-30,,INTERVENTIONAL,,,GSK3739937 First-Time-In-Human (FTIH) Study in Healthy Volunteers,"A Double-Blind (Sponsor Unblinded), Randomized, Placebo-Controlled, Single and Repeated Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK3739937 in Healthy Participants",COMPLETED,,PHASE1,91.0,ACTUAL,ViiV Healthcare,,15.0,,,f,,,,f,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,INDUSTRY,,,,,,,2021,1.0
NCT03152084,,2017-04-18,2021-03-17,,2021-05-25,2017-05-11,2017-05-12,ACTUAL,2021-05-25,2021-05-28,ACTUAL,,,,2021-05-25,2021-05-28,ACTUAL,2017-07-12,ACTUAL,2017-07-12,2021-05,2021-05-31,2020-03-20,ACTUAL,2020-03-20,2020-03-20,ACTUAL,2020-03-20,,INTERVENTIONAL,DAPASALT,Safety Set: All patients who received at least one dose of study drug and had data from at least one post-dose safety assessment available were included in the safety set.,The Study Will Evaluate Average 24-hr Sodium Excretion During Dapagliflozin Treatment in Patients With Type 2 Diabetes Mellitus With Preserved or Impaired Renal Function or Non-diabetics With Impaired Renal Function.,"DAPASALT: An Open Label, Phase IV, Mechanistic, Three-Arm Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin Treatment in Type 2 Diabetes Mellitus Patients With Either Preserved or Impaired Renal Function and Non-Diabetics With Impaired Renal Function",TERMINATED,,PHASE4,24.0,ACTUAL,AstraZeneca,"The study was prematurely closed due to unsatisfactory recruitment rate. Of 5 patients enrolled in the Group 1, none were enrolled into the Run-in set due to failure to meet inclusion/exclusion criteria, screen failure, withdrawal or other reason and hence it was decided that no more Group 1 patients would be enrolled in the study. In Group 2 and 3, 17 and 7 patients received the investigational product and completed the study, respectively.",3.0,,Poor recruitment.,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-15 14:13:07.075647,2024-10-15 14:13:07.075647,INDUSTRY,,,,,,,2020,0.0
NCT05061693,,2021-09-20,2024-08-02,,2024-08-28,2021-09-20,2021-09-29,ACTUAL,2024-08-02,2024-08-27,ACTUAL,,,,2024-08-28,2024-08-29,ACTUAL,2021-11-04,ACTUAL,2021-11-04,2024-08,2024-08-31,2024-02-28,ACTUAL,2024-02-28,2023-08-11,ACTUAL,2023-08-11,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis",COMPLETED,,PHASE2,146.0,ACTUAL,Incyte Corporation,,4.0,,,f,,,,f,t,f,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency,2024-10-16 21:24:29.407204,2024-10-16 21:24:29.407204,INDUSTRY,,,,,,,2024,1.0
NCT03674320,,2018-09-13,,,2022-01-18,2018-09-14,2018-09-17,ACTUAL,,,,,,,2022-01-18,2022-02-02,ACTUAL,2021-12-01,ESTIMATED,2021-12-01,2021-01,2021-01-31,2024-12-01,ESTIMATED,2024-12-01,2024-08-01,ESTIMATED,2024-08-01,,INTERVENTIONAL,,,Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD,Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,"The University of Texas Medical Branch, Galveston",,2.0,,No Funding,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 21:24:29.407204,2024-10-16 21:24:29.407204,OTHER,,,,,,,2024,0.0
NCT02363374,,2015-02-03,,,2023-11-28,2015-02-13,2015-02-16,ESTIMATED,,,,,,,2023-11-28,2023-12-04,ACTUAL,2015-03-25,ACTUAL,2015-03-25,2023-11,2023-11-30,2023-06-16,ACTUAL,2023-06-16,2018-09,ACTUAL,2018-09-30,,INTERVENTIONAL,CAOAROAIO-12,,Induction Chemotherapy Before or After Preoperative Chemoradiotherapy and Surgery for Locally Advanced Rectal Cancer,Induction Chemotherapy Before or After Preoperative Chemoradiotherapy and Surgery for Locally Advanced Rectal Cancer: A Randomized Phase II Trial of the German Rectal Cancer Study Group,COMPLETED,,PHASE2,311.0,ACTUAL,Goethe University,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,OTHER,,,,,,,2023,1.0
NCT03861390,,2019-03-01,2024-04-25,,2024-05-29,2019-03-01,2019-03-04,ACTUAL,2024-04-25,2024-05-23,ACTUAL,,,,2024-05-29,2024-06-25,ACTUAL,2019-03-22,ACTUAL,2019-03-22,2024-04,2024-04-30,2023-05-12,ACTUAL,2023-05-12,2023-05-12,ACTUAL,2023-05-12,,INTERVENTIONAL,Smokisone,,Woodsmoke Particulate + Prednisone,"Phase I/II Randomized, Double-blind, Placebo-controlled Cross-over Study of Prednisone on Airway Inflammatory Response to Inhaled Wood Smoke",COMPLETED,,PHASE1/PHASE2,12.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 21:24:29.407204,2024-10-16 21:24:29.407204,OTHER,,,,,,,2023,1.0
NCT04054115,,2019-08-09,,,2023-02-03,2019-08-12,2019-08-13,ACTUAL,,,,,,,2023-02-03,2023-02-08,ACTUAL,2019-07-23,ACTUAL,2019-07-23,2023-02,2023-02-28,2022-11-09,ACTUAL,2022-11-09,2021-02-24,ACTUAL,2021-02-24,,INTERVENTIONAL,Alprostadil,,Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow,The Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow After the Bidirectional Cavopulmonary Connection,TERMINATED,,PHASE1,10.0,ACTUAL,The Hospital for Sick Children,,1.0,,Covid 19 and difficulty with recruitment,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 21:24:29.407204,2024-10-16 21:24:29.407204,OTHER,,,,,,,2022,0.0
NCT01712659,,2012-10-20,2022-11-10,,2022-12-15,2012-10-20,2012-10-23,ESTIMATED,2022-12-15,2023-01-10,ACTUAL,,,,2022-12-15,2023-01-10,ACTUAL,2012-10-26,ACTUAL,2012-10-26,2022-12,2022-12-31,2022-01-18,ACTUAL,2022-01-18,2021-11-12,ACTUAL,2021-11-12,,INTERVENTIONAL,,,Ruxolitinib for Adult T-Cell Leukemia,Phase I/II Trial Evaluating the Safety and Efficacy of Ruxolitinib in Subjects With Smoldering and Chronic Adult T-cell Leukemia (ATL),TERMINATED,,PHASE1/PHASE2,19.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,The adult T-cell leukemia (ATL) research program was terminated after the death of the T-cell malignancy group Lead investigator.,f,,,,f,t,f,,,f,,,Clinical data available during the study and indefinitely.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).,,YES,All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.~All collected IPD will be shared with collaborators under the terms of collaborative agreements.,2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,NIH,,,,,,,2022,0.0
NCT03546400,,2018-05-04,,,2018-10-30,2018-06-01,2018-06-06,ACTUAL,,,,,,,2018-10-30,2018-11-01,ACTUAL,2018-09-25,ESTIMATED,2018-09-25,2018-10,2018-10-31,2020-12-03,ESTIMATED,2020-12-03,2020-12-03,ESTIMATED,2020-12-03,,INTERVENTIONAL,,,"Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.","A Phase 4, Open-label, Safety, Tolerability And Pharmacokinetic Study Of Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)",WITHDRAWN,,PHASE4,0.0,ACTUAL,Pfizer,,1.0,,The study was cancelled prior to the enrollment of any participants.,f,,,,t,t,f,,,,,,,,,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests,2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,INDUSTRY,,,,,,,2020,0.0
NCT04862650,,2021-03-26,,,2024-09-21,2021-04-26,2021-04-28,ACTUAL,,,,,,,2024-09-21,2024-09-24,ACTUAL,2021-11-30,ACTUAL,2021-11-30,2024-09,2024-09-30,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,"Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck",A Phase II Trial of the Efficacy and Safety of the Combination of Cemiplimab and Low-Dose Paclitaxel and Carboplatin in Patients with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck,SUSPENDED,,PHASE2,42.0,ESTIMATED,Ohio State University Comprehensive Cancer Center,,1.0,,Enrollment goal met,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,OTHER,,,,,,,2024,0.0
NCT04048876,,2019-07-17,2022-09-28,,2023-06-06,2019-08-06,2019-08-07,ACTUAL,2023-06-06,2023-06-07,ACTUAL,,,,2023-06-06,2023-06-07,ACTUAL,2019-08-14,ACTUAL,2019-08-14,2023-06,2023-06-30,2021-09-28,ACTUAL,2021-09-28,2021-09-28,ACTUAL,2021-09-28,,INTERVENTIONAL,,,Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study To Evaluate The Efficacy and Safety Of CC-90001 In Subjects With Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis",TERMINATED,,PHASE2,56.0,ACTUAL,Celgene,,4.0,,Business objectives have changed,f,,,,t,t,f,,,,,,See Plan Description,See Plan Description,https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,INDUSTRY,,,,,,,2021,0.0
NCT03006926,,2016-12-27,2020-10-22,,2023-11-20,2016-12-29,2016-12-30,ESTIMATED,2020-12-07,2020-12-31,ACTUAL,,,,2023-11-20,2023-12-13,ACTUAL,2017-02-13,ACTUAL,2017-02-13,2023-11,2023-11-30,2022-11-22,ACTUAL,2022-11-22,2019-10-31,ACTUAL,2019-10-31,,INTERVENTIONAL,,The efficacy analysis set included all participants who had received at least 1 dose of study drug.,A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular Carcinoma,An Open-Label Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma,COMPLETED,,PHASE1,104.0,ACTUAL,Eisai Inc.,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 10:22:11.344671,2024-10-16 10:22:11.344671,INDUSTRY,,,,,,,2022,1.0
NCT04381325,,2020-05-07,,,2023-03-31,2020-05-07,2020-05-08,ACTUAL,,,,,,,2023-03-31,2023-04-05,ACTUAL,2020-04-01,ACTUAL,2020-04-01,2023-03,2023-03-31,2022-06-08,ACTUAL,2022-06-08,2022-06-08,ACTUAL,2022-06-08,,INTERVENTIONAL,,,A Study of MSB0254 Injection in Advanced Solid Tumors,Phase I Clinical Trial to Evaluate the Safety and Tolerability and Pharmacokinetics of MSB0254 Injection in Patients With Advanced Solid Tumors,TERMINATED,,PHASE1,25.0,ACTUAL,"Suzhou Transcenta Therapeutics Co., Ltd.",,1.0,,Sponsor Decision,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,INDUSTRY,,,,,,,2022,0.0
NCT03657420,,2018-08-30,,,2019-08-12,2018-09-02,2018-09-05,ACTUAL,,,,,,,2019-08-12,2019-08-14,ACTUAL,2019-05-30,ESTIMATED,2019-05-30,2019-08,2019-08-31,2024-09-30,ESTIMATED,2024-09-30,2021-09-30,ESTIMATED,2021-09-30,,INTERVENTIONAL,,,Safety and Efficacy of ABI-009 (Nab-rapamycin) in Combination With Pomalidomide and Dexamethasone for Relapsed and Refractory Multiple Myeloma,A Phase Ib Investigation of the Safety and Efficacy of ABI-009 (Nab-rapamycin) in Combination With Pomalidomide and Dexamethasone for Relapsed and Refractory Multiple Myeloma,WITHDRAWN,,PHASE1,0.0,ACTUAL,Massachusetts General Hospital,,1.0,,Funding withdrawn by sponsor,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:24:29.407204,2024-10-16 21:24:29.407204,OTHER,,,,,,,2024,0.0
NCT04476251,,2020-07-16,2021-11-09,,2021-12-07,2020-07-16,2020-07-20,ACTUAL,2021-11-09,2021-12-08,ACTUAL,,,,2021-12-07,2021-12-15,ACTUAL,2021-01-14,ACTUAL,2021-01-14,2021-12,2021-12-31,2021-09-15,ACTUAL,2021-09-15,2021-09-15,ACTUAL,2021-09-15,,INTERVENTIONAL,,,E7 TCR T Cell Induction Immunotherapy for Stage IIB-IVA Cervical Cancer,A Pilot Study of E7 TCR T Cell Induction Immunotherapy for Stage IIB-IVA Cervical Cancer,TERMINATED,,EARLY_PHASE1,1.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,Multiple logistical challenges,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:34:14.786307,2024-10-16 00:34:14.786307,NIH,,,,,,,2021,0.0
NCT04305327,,2020-03-10,2023-12-18,,2024-07-31,2020-03-10,2020-03-12,ACTUAL,2024-02-05,2024-02-28,ACTUAL,,,,2024-07-31,2024-08-28,ACTUAL,2022-12-07,ACTUAL,2022-12-07,2024-07,2024-07-31,2023-05-05,ACTUAL,2023-05-05,2023-05-05,ACTUAL,2023-05-05,,INTERVENTIONAL,EMBRACE 1,"Due to low enrollment, baseline data are not reported to protect participant confidentiality.",Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis,"A Phase 3, Randomised, Double-blind, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Brodalumab Treatment Compared to Placebo and Ustekinumab in Adolescent Subjects With Moderate-to-severe Plaque Psoriasis",TERMINATED,,PHASE3,12.0,ACTUAL,LEO Pharma,,4.0,,Early terminated due to difficulty recruiting participants,f,,,,t,t,f,,,t,,,,De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.,http://leopharmatrials.com/for-researchers,YES,,2024-10-16 21:24:29.407204,2024-10-16 21:24:29.407204,INDUSTRY,,,,,,,2023,0.0
NCT03847272,,2019-02-15,,,2024-01-10,2019-02-19,2019-02-20,ACTUAL,,,,,,,2024-01-10,2024-01-12,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2024-01,2024-01-31,2023-10-25,ACTUAL,2023-10-25,2023-10-25,ACTUAL,2023-10-25,,INTERVENTIONAL,USTEKINISU,,A Multicenter Phase 2 Single-arm Proof-of-concept Trial to Assess the Efficacy and Safety of Ustekinumab in Association With Prednisone for the Treatment of Non-infectious Severe Uveitis (NISU),A Multicenter Phase 2 Single-arm Proof-of-concept Trial to Assess the Efficacy and Safety of Ustekinumab in Association With Prednisone for the Treatment of Non-infectious Severe Uveitis (NISU),TERMINATED,,PHASE2,15.0,ACTUAL,Centre Hospitalier Universitaire Dijon,,1.0,,The long inclusion period meant that the question could not be answered within an appropriate timeframe.,f,,,,,f,f,,,,,,,,,,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER,,,,,,,2023,0.0
NCT04560166,,2020-09-17,2024-02-08,,2024-03-14,2020-09-22,2020-09-23,ACTUAL,2024-03-14,2024-03-18,ACTUAL,,,,2024-03-14,2024-03-18,ACTUAL,2021-11-08,ACTUAL,2021-11-08,2024-02,2024-02-29,2022-09-21,ACTUAL,2022-09-21,2022-09-21,ACTUAL,2022-09-21,,INTERVENTIONAL,,,Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma,"Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor in Combination With Irinotecan and Temozolomide in Patients With High-Risk Neuroblastoma With Primary Refractory Disease or in First Relapse. An International, Single-Arm, Multicenter Phase 2 Trial.",TERMINATED,,PHASE2,2.0,ACTUAL,Y-mAbs Therapeutics,Terminated due to business priorities resulting from slow recruitment.,1.0,,Due to business priorities,f,,,,t,t,f,,,,,,,,,,,2024-10-15 14:13:07.075647,2024-10-15 14:13:07.075647,INDUSTRY,,,,,,,2022,0.0
NCT02691182,,2016-02-02,2024-01-08,,2024-04-22,2016-02-19,2016-02-25,ESTIMATED,2024-04-22,2024-05-16,ACTUAL,,,,2024-04-22,2024-05-16,ACTUAL,2016-04,ACTUAL,2016-04-30,2024-04,2024-04-30,2021-05,ACTUAL,2021-05-31,2021-05,ACTUAL,2021-05-31,,INTERVENTIONAL,,Safety Population: Safety population is defined as all subjects who received at least 1 dose of study drug during the study.,Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4),Open-Label Extension Study to Evaluate the Long-Term Safety of Molindone Hydrochloride Extended-Release Tablets for the Treatment of Impulsive Aggression in Pediatric and Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment,TERMINATED,,PHASE3,491.0,ACTUAL,"Supernus Pharmaceuticals, Inc.",,1.0,,The program was shut down due to a lack of efficacy.,f,,,,,,,,,,,,,,,,,2024-10-15 14:13:07.075647,2024-10-15 14:13:07.075647,INDUSTRY,,,,,,,2021,0.0
NCT00321698,,2006-05-02,2014-12-30,,2024-08-26,2006-05-02,2006-05-04,ESTIMATED,2016-12-28,2016-12-30,ESTIMATED,,,,2024-08-26,2024-08-29,ACTUAL,2006-04-21,ACTUAL,2006-04-21,2024-08,2024-08-31,2023-08-18,ACTUAL,2023-08-18,2009-10-01,ACTUAL,2009-10-01,,INTERVENTIONAL,,,Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer,Phase I/II Study of Preoperative Radiation and Docetaxel Activity in High Risk Localized Prostate Cancer,TERMINATED,,PHASE1/PHASE2,25.0,ACTUAL,OHSU Knight Cancer Institute,Patient accrual was not completed due to the sponsor withdrawing funding.,2.0,,Funding withdrawal,f,,,,t,,,,,,,,,,,,,2024-10-16 21:24:29.407204,2024-10-16 21:24:29.407204,OTHER,,,,,,,2023,0.0
NCT03897946,,2019-03-29,,,2021-03-01,2019-03-29,2019-04-01,ACTUAL,,,,,,,2021-03-01,2021-03-03,ACTUAL,2019-08-20,ACTUAL,2019-08-20,2021-03,2021-03-31,2021-02-05,ACTUAL,2021-02-05,2021-02-05,ACTUAL,2021-02-05,,INTERVENTIONAL,,,Evaluating Immunogenicity of a Birth Dose of HBV Vaccine in the DRC,Evaluating Immunogenicity of a Birth Dose of HBV Vaccine in the DRC,COMPLETED,,PHASE4,569.0,ACTUAL,"University of North Carolina, Chapel Hill",,3.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,OTHER,,,,,,,2021,1.0
NCT03366103,,2017-12-07,2022-11-30,,2023-09-22,2017-12-07,2017-12-08,ACTUAL,2023-04-27,2023-05-03,ACTUAL,,,,2023-09-22,2023-10-17,ACTUAL,2018-03-20,ACTUAL,2018-03-20,2023-09,2023-09-30,2022-09-21,ACTUAL,2022-09-21,2021-07-28,ACTUAL,2021-07-28,,INTERVENTIONAL,,,Navitoclax and Vistusertib in Treating Patients With Relapsed Small Cell Lung Cancer and Other Solid Tumors,Phase 1/2 Study of Navitoclax Plus Vistusertib in Patients With Relapsed Small Cell Lung Cancer (SCLC) and Other Solid Tumors,TERMINATED,,PHASE1/PHASE2,15.0,ACTUAL,National Cancer Institute (NCI),Only 1 participant was enrolled to Phase 2 before the study was closed to accrual for low accrual.,1.0,,Drug supply issues,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,NIH,,,,,,,2022,0.0
NCT02395848,,2015-02-26,2022-02-28,,2022-06-13,2015-03-17,2015-03-24,ESTIMATED,2022-06-13,2023-03-24,ACTUAL,,,,2022-06-13,2023-03-24,ACTUAL,2015-07,,2015-07-31,2022-06,2022-06-30,2021-08-30,ACTUAL,2021-08-30,2021-08-30,ACTUAL,2021-08-30,,INTERVENTIONAL,,,Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection,"Prospective, Open-label Trial to Evaluate Efficacy of 30-day Duration of Fidaxomicin in Patients With Recurrent C. Difficile Infection",TERMINATED,,PHASE3,31.0,ACTUAL,McMaster University,,1.0,,Insufficient resource to complete the study,f,,,,t,,,,,,,,,,,,,2024-10-16 21:24:29.407204,2024-10-16 21:24:29.407204,OTHER,,,,,,,2021,0.0
NCT03242772,,2017-08-04,2021-12-20,,2022-03-11,2017-08-07,2017-08-08,ACTUAL,2022-02-11,2022-03-09,ACTUAL,,,,2022-03-11,2022-03-22,ACTUAL,2018-12-14,ACTUAL,2018-12-14,2022-03,2022-03-31,2021-04-19,ACTUAL,2021-04-19,2020-12-28,ACTUAL,2020-12-28,,INTERVENTIONAL,,,Impact of Combined Medication and Behavioral Treatment for ASD & ADHD,Impact of Combined Medication and Behavioral Treatment in Young Children With Comorbid ASD and ADHD,TERMINATED,,PHASE2,18.0,ACTUAL,Duke University,,2.0,,The study stopped recruitment of new participants due to COVID. A substudy was developed with adaptations to the main design.,f,,,,t,t,f,,,f,,,1 year after publication of the results for each of the specific aims or 3 years after the statistical analyses are completed,determined by committee of researchers/administrator at NDAR,https://nda.nih.gov,YES,"Through NDAR, core assessment and diagnostic data that is de-identified, including measures such as ADOS and Vineland.",2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,OTHER,,,,,,,2021,0.0
NCT05270265,,2022-01-28,,,2024-08-07,2022-03-07,2022-03-08,ACTUAL,,,,,,,2024-08-07,2024-08-09,ACTUAL,2022-02-09,ACTUAL,2022-02-09,2024-08,2024-08-31,2023-07-31,ACTUAL,2023-07-31,2023-07-31,ACTUAL,2023-07-31,,INTERVENTIONAL,,,Safety and Immunogenicity of Pvs25-IMX313/Matrix-M1 Vaccine,A Phase Ia Study to Assess Safety and Immunogenicity of the Plasmodium Vivax Malaria Vaccine Candidate Pvs25-IMX313 in Matrix-M1 Adjuvant in Healthy Adults Living in the UK,TERMINATED,,EARLY_PHASE1,25.0,ACTUAL,University of Oxford,,3.0,,"The study was terminated due to administrative delays in the approval of a substantial amendment to extend the shelf-life of Pvs25-IMX313. Regulatory approval was only received on 11 August 2023, after end of study visits had already been conducted.",f,,,,t,f,f,,,,,,,,,,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER,,,,,,,2023,0.0
NCT05405439,,2022-05-24,,,2023-11-01,2022-06-01,2022-06-06,ACTUAL,,,,,,,2023-11-01,2023-11-03,ACTUAL,2022-08-25,ACTUAL,2022-08-25,2023-11,2023-11-30,2023-07-19,ACTUAL,2023-07-19,2023-07-19,ACTUAL,2023-07-19,,INTERVENTIONAL,,,To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer,Phase Ib/II Clinical Study of TQB3823 Tablets Combined With Abiraterone Acetate Tablets and Prednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer,TERMINATED,,PHASE1/PHASE2,39.0,ACTUAL,"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",,1.0,,The sponsor voluntarily terminated the study,f,,,,,f,f,,,,,,,,,,,2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,INDUSTRY,,,,,,,2023,0.0
NCT04988867,,2021-07-23,2024-08-19,,2024-09-17,2021-08-03,2021-08-04,ACTUAL,2024-09-17,2024-09-24,ACTUAL,,,,2024-09-17,2024-09-24,ACTUAL,2021-09-22,ACTUAL,2021-09-22,2024-09,2024-09-30,2023-05-31,ACTUAL,2023-05-31,2023-05-31,ACTUAL,2023-05-31,,INTERVENTIONAL,DAFFODIL™,All patients enrolled and treated,An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome,An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome,TERMINATED,,PHASE2/PHASE3,15.0,ACTUAL,ACADIA Pharmaceuticals Inc.,"As a result of marketing approval of trofinetide on 10 March 2023, the study was terminated by the Sponsor with the intent of switching patients to commercially available product. The study was terminated on 31 May 2023.",1.0,,"As a result of marketing approval of trofinetide on 10 March 2023, the study was terminated by the Sponsor with the intent of switching patients to commercially available product.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,INDUSTRY,,,,,,,2023,0.0
NCT02699723,,2016-03-01,,,2020-10-20,2016-03-01,2016-03-04,ESTIMATED,,,,,,,2020-10-20,2020-10-22,ACTUAL,2020-12,ESTIMATED,2020-12-31,2020-10,2020-10-31,2021-09,ESTIMATED,2021-09-30,2021-09,ESTIMATED,2021-09-30,,INTERVENTIONAL,,,Arsenic Trioxide and Itraconazole in Treating Patients With Advanced Basal Cell Cancer,Oral Arsenic Trioxide and Itraconazole for the Treatment of Patients With Advanced Basal Cell Carcinoma,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Stanford University,,1.0,,Logistics,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,OTHER,,,,,,,2021,0.0
NCT03412747,,2018-01-22,2022-02-04,2020-02-06,2023-12-15,2018-01-25,2018-01-26,ACTUAL,2022-02-04,2022-03-02,ACTUAL,2020-02-06,2020-02-11,ACTUAL,2023-12-15,2023-12-20,ACTUAL,2018-01-26,ACTUAL,2018-01-26,2023-12,2023-12-31,2020-02-26,ACTUAL,2020-02-26,2019-02-07,ACTUAL,2019-02-07,,INTERVENTIONAL,BE SURE,Baseline Characteristics refer to the Randomized Set (RS) which consisted of all randomized study participants.,A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis,"A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis",COMPLETED,,PHASE3,478.0,ACTUAL,UCB Pharma,,3.0,,,f,,,,t,t,f,,,f,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",http://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,INDUSTRY,,,,,,,2020,1.0
NCT04700046,,2021-01-05,,,2024-05-03,2021-01-05,2021-01-07,ACTUAL,,,,,,,2024-05-03,2024-05-06,ACTUAL,2021-09-03,ACTUAL,2021-09-03,2024-05,2024-05-31,2024-08-12,ESTIMATED,2024-08-12,2024-07-01,ESTIMATED,2024-07-01,,INTERVENTIONAL,MIND,,Study to Investigate the Efficacy and Safety of Mexiletine in Patients With Myotonic Dystrophy Type 1 and Type 2,"A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Investigate the Efficacy and Safety of Mexiletine During 26 Weeks of Treatment in Patients With Myotonic Dystrophy Type 1 and Type 2 [The MIND Study]",WITHDRAWN,,PHASE3,0.0,ACTUAL,Lupin Ltd.,,2.0,,Assessing novel alternative study designs and regulatory pathways,f,,,,t,f,f,,,,,,,,,,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,INDUSTRY,,,,,,,2024,0.0
NCT04390503,,2020-05-14,2023-03-22,,2024-08-04,2020-05-14,2020-05-15,ACTUAL,2024-08-04,2024-08-28,ACTUAL,,,,2024-08-04,2024-08-28,ACTUAL,2021-03-12,ACTUAL,2021-03-12,2024-08,2024-08-31,2022-01-06,ACTUAL,2022-01-06,2022-01-06,ACTUAL,2022-01-06,,INTERVENTIONAL,,,Convalescent Plasma for Early Treatment of COVID-19,"A Phase 2 Randomized, Double-blinded Trial to Evaluate the Efficacy and Safety of Human Anti-SARS-CoV-2 Plasma for Early Treatment of COVID-19",TERMINATED,,PHASE2,223.0,ACTUAL,Columbia University,,2.0,,Enrollment challenges,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:24:29.407204,2024-10-16 21:24:29.407204,OTHER,,,,,,,2022,0.0
NCT05559476,,2022-09-26,2024-03-07,,2024-09-09,2022-09-26,2022-09-29,ACTUAL,2024-03-07,2024-04-04,ACTUAL,,,,2024-09-09,2024-09-24,ACTUAL,2022-10-20,ACTUAL,2022-10-20,2024-09,2024-09-30,2023-08-15,ACTUAL,2023-08-15,2023-03-07,ACTUAL,2023-03-07,,INTERVENTIONAL,,,A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above,"A Phase 3, Open-label, Randomized, Controlled, Multicountry Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU HD Vaccine in Adults Aged 65 Years and Above",COMPLETED,,PHASE3,1029.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,f,t,f,,,t,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf,YES,"GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf",2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,INDUSTRY,,,,,,,2023,1.0
NCT04451174,,2020-06-26,,,2021-05-30,2020-06-26,2020-06-30,ACTUAL,,,,,,,2021-05-30,2021-06-03,ACTUAL,2020-06-23,ACTUAL,2020-06-23,2021-05,2021-05-31,2021-01-30,ACTUAL,2021-01-30,2021-01-30,ACTUAL,2021-01-30,,INTERVENTIONAL,PREDCOVID,,Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia,Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID),TERMINATED,,PHASE3,60.0,ACTUAL,University of Chile,,2.0,,Corticosteroid use approval,f,,,,f,f,f,,,,,,starting 6 months after publication,,,YES,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,OTHER,,,,,,,2021,0.0
NCT04547985,,2020-08-31,2024-06-28,,2024-08-06,2020-09-11,2020-09-14,ACTUAL,2024-08-06,2024-08-28,ACTUAL,,,,2024-08-06,2024-08-28,ACTUAL,2021-01-05,ACTUAL,2021-01-05,2024-08,2024-08-31,2023-10-16,ACTUAL,2023-10-16,2023-10-16,ACTUAL,2023-10-16,,INTERVENTIONAL,PGD,,Naltrexone Treatment for Prolonged Grief Disorder (PGD),Naltrexone Treatment for Prolonged Grief Disorder: A Pilot Study,TERMINATED,,PHASE4,9.0,ACTUAL,Weill Medical College of Cornell University,"Due to low accrual, only descriptive statistics are presented.",2.0,,We are terminating the study due to low accrual.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,OTHER,,,,,,,2023,0.0
NCT02920008,,2016-09-28,2023-01-13,2021-01-15,2024-07-31,2016-09-28,2016-09-30,ESTIMATED,2023-05-01,2023-05-25,ACTUAL,,2023-05-25,ACTUAL,2024-07-31,2024-08-28,ACTUAL,2017-03-16,ACTUAL,2017-03-16,2024-07,2024-07-31,2020-06-01,ACTUAL,2020-06-01,2020-01-20,ACTUAL,2020-01-20,,INTERVENTIONAL,,,"Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia","A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Previously Treated Acute Myeloid Leukemia",COMPLETED,,PHASE3,302.0,ACTUAL,"Astex Pharmaceuticals, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,INDUSTRY,,,,,,,2020,1.0
NCT05059873,,2021-09-18,,,2024-08-27,2021-09-18,2021-09-28,ACTUAL,,,,,,,2024-08-27,2024-08-28,ACTUAL,2023-03-05,ACTUAL,2023-03-05,2024-08,2024-08-31,2024-05-31,ACTUAL,2024-05-31,2024-04-30,ACTUAL,2024-04-30,,INTERVENTIONAL,,,Treatment Efficacy of Systemic Corticosteroids in AECOPD Patients With Higher Blood Eosinophil Levels,A Multicenter Double-blind Randomized Controlled Trial of Systemic Corticosteroid Therapy in AECOPD Patients Admitted to Hospital With Higher Blood Eosinophil Levels,TERMINATED,,PHASE4,11.0,ACTUAL,Capital Medical University,,2.0,,Difficulty in recruiting subjects,f,,,,t,f,f,,,,,,After the main results of the ECHO study have been published,Supporting information will be available from the corresponding author Zhaohui Tong (Email: tongzhaohuicy@sina.com),,YES,Data about individual deidentified participants of this trial will be available from the corresponding author Zhaohui Tong (Email: tongzhaohuicy@sina.com) on reasonable request after the main results of the ECHO study have been published,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,OTHER,,,,,,,2024,0.0
NCT03693612,,2018-10-01,2022-06-10,,2024-08-05,2018-10-01,2018-10-03,ACTUAL,2022-07-28,2022-08-22,ACTUAL,,,,2024-08-05,2024-08-28,ACTUAL,2018-11-26,ACTUAL,2018-11-26,2024-08,2024-08-31,2021-09-16,ACTUAL,2021-09-16,2021-06-25,ACTUAL,2021-06-25,,INTERVENTIONAL,,The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.,GSK3359609 Plus Tremelimumab for the Treatment of Advanced Solid Tumors,"A Phase I/II, Open-label, Two Part Study of GSK3359609 in Combination With Tremelimumab in Participants With Selected, Advanced Solid Tumors",COMPLETED,,PHASE1/PHASE2,26.0,ACTUAL,GlaxoSmithKline,The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.,3.0,,,f,,,,f,t,f,,,,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf,YES,"GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf",2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,INDUSTRY,,,,,,,2021,0.0
NCT04482686,,2020-07-21,,,2024-09-20,2020-07-21,2020-07-22,ACTUAL,,,,,,,2024-09-20,2024-09-24,ACTUAL,2020-12-09,ACTUAL,2020-12-09,2024-09,2024-09-30,2022-07-15,ACTUAL,2022-07-15,2022-05-15,ACTUAL,2022-05-15,,INTERVENTIONAL,,,Trial of Combination Therapy to Treat COVID-19 Infection,A Phase I Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infection,COMPLETED,,PHASE1,31.0,ACTUAL,ProgenaBiome,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,OTHER,,,,,,,2022,1.0
NCT04809649,,2021-03-01,,,2021-07-13,2021-03-18,2021-03-22,ACTUAL,,,,,,,2021-07-13,2021-07-19,ACTUAL,2021-05-15,ESTIMATED,2021-05-15,2021-07,2021-07-31,2022-09,ESTIMATED,2022-09-30,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,SITRIS,,SUBA-Itraconazole Therapy for Coccidioidomycosis Refractory or Intolerant to Fluconazole,SUBA-Itraconazole Therapy for Coccidioidomycosis Refractory or Intolerant to Fluconazole,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, Davis",,1.0,,Sponsor is not proceeding with study due to budget cuts as a result of COVID-19.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER,,,,,,,2022,0.0
NCT04436471,,2020-06-16,,,2020-08-11,2020-06-17,2020-06-18,ACTUAL,,,,,,,2020-08-11,2020-08-12,ACTUAL,2020-06-17,ACTUAL,2020-06-17,2020-06,2020-06-30,2020-08-10,ACTUAL,2020-08-10,2020-08-03,ACTUAL,2020-08-03,,INTERVENTIONAL,,,"An Open Study of the Safety, Tolerability and Immunogenicity of the Drug Gam-COVID-Vac Vaccine Against COVID-19","An Open Study of the Safety, Tolerability and Immunogenicity of the Drug Gam-COVID-Vac a Solution for Intramuscular Injection With the Participation of Healthy Volunteers",COMPLETED,,PHASE1/PHASE2,38.0,ACTUAL,"Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation",,3.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,OTHER,,,,,,,2020,1.0
NCT03187210,,2017-06-12,,,2024-05-07,2017-06-13,2017-06-14,ACTUAL,,,,,,,2024-05-07,2024-05-09,ACTUAL,2018-09-01,ACTUAL,2018-09-01,2024-05,2024-05-31,2024-11-30,ESTIMATED,2024-11-30,2023-11-02,ACTUAL,2023-11-02,,INTERVENTIONAL,BAL,,Brentuximab Vedotin and BeEAM High-dose Chemotherapy in Lymphomas,"Brentuximab Vedotin and BeEAM High-dose Chemotherapy (B-BeEAM) With Autologous Stem Cell Transplantation for CD30+ Lymphomas, a Phase I/II Study",SUSPENDED,,PHASE1/PHASE2,20.0,ACTUAL,"Insel Gruppe AG, University Hospital Bern",,3.0,,low accrual,f,,,,f,f,f,,,,,,,,,YES,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER,,,,,,,2024,0.0
NCT05180318,,2021-12-01,,,2024-04-25,2022-01-05,2022-01-06,ACTUAL,,,,,,,2024-04-25,2024-04-29,ACTUAL,2024-10-01,ESTIMATED,2024-10-01,2024-04,2024-04-30,2024-12-31,ESTIMATED,2024-12-31,2024-11-30,ESTIMATED,2024-11-30,,INTERVENTIONAL,,,Prophylactic Effects of Esketamine in Surgical Patients,Effects of Esketamine Pre-administration on Blood Lymphocyte Subsets and Inflammatory Factors in Early Postoperative Period:,WITHDRAWN,,PHASE4,0.0,ACTUAL,"Wuhan Union Hospital, China",,2.0,,No Participants Enrolled,f,,,,f,f,f,,,,,,Six months after publication.,Upon reasonable request.,,YES,"After publication, the data supporting the findings of this study can be provided by the corresponding author upon reasonable request. Participant data without names and identifiers can be provided by the corresponding author and the Wuhan Union Hospital after approval. The research team will provide an email address for communication purposes once approval is obtained regarding sharing the data with others. The proposal with detailed description of the study objectives and statistical analysis plan will be needed for evaluation of the purpose for the data request. Additional materials may also be required during the process of evaluation.",2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,OTHER,,,,,,,2024,0.0
NCT03963232,,2019-05-16,2022-06-29,,2023-03-01,2019-05-23,2019-05-24,ACTUAL,2022-07-27,2022-08-19,ACTUAL,,,,2023-03-01,2023-03-28,ACTUAL,2019-07-30,ACTUAL,2019-07-30,2023-03,2023-03-31,2022-03-11,ACTUAL,2022-03-11,2021-07-27,ACTUAL,2021-07-27,,INTERVENTIONAL,PERSIST,All randomized participants.,A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Galcanezumab in Patients With Episodic Migraine-the Persist Study",COMPLETED,,PHASE3,520.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,INDUSTRY,,,,,,,2022,1.0
NCT03977675,,2019-06-05,,,2021-01-20,2019-06-05,2019-06-06,ACTUAL,,,,,,,2021-01-20,2021-01-22,ACTUAL,2019-05-15,ACTUAL,2019-05-15,2021-01,2021-01-31,2020-07-02,ACTUAL,2020-07-02,2020-07-02,ACTUAL,2020-07-02,,INTERVENTIONAL,,,The Role of HNKs in the Antidepressant Effect of Ketamine,The Role of HNKs in the Antidepressant Effect of Ketamine,TERMINATED,,PHASE1,8.0,ACTUAL,Columbia University,,3.0,,PI left the institution,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 14:13:07.075647,2024-10-15 14:13:07.075647,OTHER,,,,,,,2020,0.0
NCT04059757,,2019-08-07,,,2022-07-01,2019-08-14,2019-08-16,ACTUAL,,,,,,,2022-07-01,2022-07-07,ACTUAL,2022-05,ESTIMATED,2022-05-31,2022-07,2022-07-31,2023-09,ESTIMATED,2023-09-30,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,Fecal Microbiota Transplantation For The Treatment Of Gastro-Intestinal Acute GVHD,Fecal Microbiota Transplantation For The Treatment Of Gastro-Intestinal Acute Graft Versus Host Disease,WITHDRAWN,,PHASE2,0.0,ACTUAL,Case Comprehensive Cancer Center,,1.0,,Drugs unavailable,f,,,,t,t,f,,,,,,Beginning 3 months and ending 5 years following article publication,Investigators who provide a methodologically sound proposal for use of requested data.,,YES,Individual participant data that underline or influence the results observed from the study.,2024-10-15 14:13:07.075647,2024-10-15 14:13:07.075647,OTHER,,,,,,,2023,0.0
NCT02975570,,2016-10-21,,,2017-09-07,2016-11-28,2016-11-29,ESTIMATED,,,,,,,2017-09-07,2017-09-11,ACTUAL,2017-08,ESTIMATED,2017-08-31,2017-09,2017-09-30,2022-08,ESTIMATED,2022-08-31,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,DAZZLE,,"Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin","Prospective, Randomized, Open Label Phase 3 Study of the Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin for Treatment of Patients With Fluoroquinolone-susceptible Multidrugresistant--Tuberculosis (MDR-TB)",WITHDRAWN,,PHASE3,0.0,ACTUAL,Boston University,,6.0,,The study could not be conducted since funding was not obtained.,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-15 14:13:07.075647,2024-10-15 14:13:07.075647,OTHER,,,,,,,2022,0.0
NCT04905563,,2021-05-21,2024-01-16,,2024-03-06,2021-05-26,2021-05-27,ACTUAL,2024-03-06,2024-03-08,ACTUAL,,,,2024-03-06,2024-03-08,ACTUAL,2021-06-07,ACTUAL,2021-06-07,2024-03,2024-03-31,2024-01-05,ACTUAL,2024-01-05,2024-01-05,ACTUAL,2024-01-05,,INTERVENTIONAL,,,NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures,"Post-operative Pain Management in Supracondylar Humerus Fractures: A Randomized, Double-blinded, Prospective Study",TERMINATED,,PHASE4,30.0,ACTUAL,Le Bonheur Children's Hospital,,2.0,,Clinical evidence supporting the hypothesis of this study has been published,f,,,,f,t,f,,,t,,,,,,NO,No Plan has been made for such data sharing,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER,,,,,,,2024,0.0
NCT03628391,,2017-10-09,,,2022-05-06,2018-08-09,2018-08-14,ACTUAL,,,,,,,2022-05-06,2022-05-11,ACTUAL,2018-02-22,ACTUAL,2018-02-22,2022-05,2022-05-31,2021-01-23,ACTUAL,2021-01-23,2020-02-03,ACTUAL,2020-02-03,,INTERVENTIONAL,EuRIDICE,,Haloperidol for Delirium in Adult Critically Ill Patients,Efficacy of Haloperidol to Decrease the Burden of Delirium in Adult Critically Ill Patients (EuRIDICE): a Prospective Randomised Multi-center Double-blind Placebo-controlled Clinical Trial,TERMINATED,,PHASE3,142.0,ACTUAL,Erasmus Medical Center,,2.0,,The study was stopped because of futility of being able to reach a one-day difference between treatment groups in the primary outcome of DCFD in the intended sample size.,f,,,,t,f,f,,,f,,,,,,UNDECIDED,Can be retrieved after contacting the principal investigator,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER,,,,,,,2021,0.0
NCT00075946,,2004-01-12,2015-02-09,,2024-01-30,2004-01-13,2004-01-14,ESTIMATED,2015-06-03,2015-06-22,ESTIMATED,,,,2024-01-30,2024-02-01,ACTUAL,2004-01-23,ACTUAL,2004-01-23,2024-01,2024-01-31,2021-08,ACTUAL,2021-08-31,2013-09,ACTUAL,2013-09-30,,INTERVENTIONAL,,"As the primary analysis only includes randomized patients, the baseline characteristics were provided among patients who were correctly randomized to one of the two arms for maintenance therapy.",Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma,Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma,COMPLETED,,PHASE3,545.0,ACTUAL,Eastern Cooperative Oncology Group,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,NETWORK,,,,,,,2021,1.0
NCT04863248,,2021-04-16,2023-01-23,,2023-03-23,2021-04-23,2021-04-28,ACTUAL,2023-03-23,2023-04-14,ACTUAL,,,,2023-03-23,2023-04-14,ACTUAL,2021-04-30,ACTUAL,2021-04-30,2023-01,2023-01-31,2022-02-02,ACTUAL,2022-02-02,2022-02-02,ACTUAL,2022-02-02,,INTERVENTIONAL,PRESERVE 4,,"Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Docetaxel for Metastatic Non-Small Cell Lung Cancer (NSCLC) (PRESERVE 4)","A Phase 2 Randomized, Double-blind, Clinical Trial of Trilaciclib Versus Placebo in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Treated With Docetaxel in the 2nd/3rd Line Setting (PRESERVE 4)",TERMINATED,,PHASE2,10.0,ACTUAL,"G1 Therapeutics, Inc.","This study was terminated earlier than initially proposed by the Sponsor for non-safety related reasons; only 7 patients were randomized and treated. Therefore, only limited safety summary tables were generated, and no efficacy analyses were conducted.",2.0,,"Treatment paradigm in second- and third-line NSCLC is shifting away from docetaxel, the backbone chemotherapy therapy used in this study.",f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,INDUSTRY,,,,,,,2022,0.0
NCT02092324,,2014-03-18,2020-08-17,,2020-10-22,2014-03-18,2014-03-20,ESTIMATED,2020-10-22,2020-11-16,ACTUAL,,,,2020-10-22,2020-11-16,ACTUAL,2014-07-08,ACTUAL,2014-07-08,2020-10,2020-10-31,2020-01-24,ACTUAL,2020-01-24,2019-11-22,ACTUAL,2019-11-22,,INTERVENTIONAL,,,Ruxolitinib Phosphate in Treating Patients With Chronic Neutrophilic Leukemia or Atypical Chronic Myeloid Leukemia,Prospective Evaluation of Ruxolitinib Efficacy for CNL/aCML Patients With Mutation of CSF3R,COMPLETED,,PHASE2,51.0,ACTUAL,OHSU Knight Cancer Institute,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER,,,,,,,2020,1.0
NCT03526861,,2018-05-04,2021-09-30,2021-03-24,2024-08-06,2018-05-04,2018-05-16,ACTUAL,2021-09-30,2021-10-29,ACTUAL,2021-03-24,2021-03-29,ACTUAL,2024-08-06,2024-08-29,ACTUAL,2018-06-19,ACTUAL,2018-06-19,2023-05,2023-05-31,2021-03-16,ACTUAL,2021-03-16,2020-04-15,ACTUAL,2020-04-15,,INTERVENTIONAL,,,Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).,"A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy",COMPLETED,,PHASE3,301.0,ACTUAL,LEO Pharma,,8.0,,,f,,,,t,t,f,,,,,,,De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.,http://leopharmatrials.com/en/for-researchers,YES,,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,INDUSTRY,,,,,,,2021,1.0
NCT03852472,,2019-02-22,2023-08-09,,2024-02-14,2019-02-22,2019-02-25,ACTUAL,2024-02-14,2024-03-15,ACTUAL,,,,2024-02-14,2024-03-15,ACTUAL,2018-12-21,ACTUAL,2018-12-21,2024-02,2024-02-29,2021-03-09,ACTUAL,2021-03-09,2021-01-14,ACTUAL,2021-01-14,,INTERVENTIONAL,,,Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA),"A Randomized , Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa",COMPLETED,,PHASE2,435.0,ACTUAL,ChemoCentryx,,5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,INDUSTRY,,,,,,,2021,1.0
NCT05077085,,2021-09-21,,,2023-03-24,2021-09-30,2021-10-13,ACTUAL,,,,,,,2023-03-24,2023-03-28,ACTUAL,2022-01,ESTIMATED,2022-01-31,2023-03,2023-03-31,2024-12,ESTIMATED,2024-12-31,2024-07,ESTIMATED,2024-07-31,,INTERVENTIONAL,BSTEP,,Bezlotoxumab Versus FMT for Multiple Recurrent CDI,New Treatment Strategy for Patients With Multiple Recurrent Clostridioides Difficile Infection With Bezlotoxumab as First Option,WITHDRAWN,,PHASE4,0.0,ACTUAL,Leiden University Medical Center,,2.0,,Withdrawn,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,OTHER,,,,,,,2024,0.0
NCT03539900,,2018-05-16,2023-04-17,,2024-03-11,2018-05-16,2018-05-29,ACTUAL,2023-06-30,2023-07-24,ACTUAL,,,,2024-03-11,2024-04-03,ACTUAL,2018-04-17,ACTUAL,2018-04-17,2024-03,2024-03-31,2023-03-22,ACTUAL,2023-03-22,2022-04-19,ACTUAL,2022-04-19,,INTERVENTIONAL,,,Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder,Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder,COMPLETED,,PHASE2/PHASE3,89.0,ACTUAL,Yale University,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,OTHER,,,,,,,2023,1.0
NCT03461952,,2018-03-05,2022-02-28,,2024-02-20,2018-03-05,2018-03-12,ACTUAL,2024-02-20,2024-02-22,ACTUAL,,,,2024-02-20,2024-02-22,ACTUAL,2019-03-11,ACTUAL,2019-03-11,2024-02,2024-02-29,2022-02-09,ACTUAL,2022-02-09,2021-06-01,ACTUAL,2021-06-01,,INTERVENTIONAL,NIMBLe,,Nivolumab Ipilimumab in Patients With hyperMutated Cancers Detected in Blood (NIMBLe),"A Phase II Open Label, Randomized Non-Comparative Trial of Nivolumab Alone or in Combination With Ipilimumab for the Treatment of Patients With Advanced Hypermutated Solid Tumors Detected by a Blood Based Assay",TERMINATED,,PHASE2,4.0,ACTUAL,Canadian Cancer Trials Group,,2.0,,cfDNA screening data found that the prevalence of POLE/POLD1 mutations was lower than expected. It was determined that there are no feasible options to amend this study in a fashion that would not be duplicative of other currently accruing trials.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,NETWORK,,,,,,,2022,0.0
NCT03978637,,2019-06-05,,,2023-11-10,2019-06-05,2019-06-07,ACTUAL,,,,,,,2023-11-10,2023-11-14,ACTUAL,2020-02-04,ACTUAL,2020-02-04,2023-11,2023-11-30,2023-10-13,ACTUAL,2023-10-13,2023-10-13,ACTUAL,2023-10-13,,INTERVENTIONAL,,,Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation,"An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation",TERMINATED,,PHASE1/PHASE2,23.0,ACTUAL,Incyte Corporation,,4.0,,Business Decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,INDUSTRY,,,,,,,2023,0.0
NCT03664674,,2018-08-31,2022-10-20,,2022-11-15,2018-09-06,2018-09-10,ACTUAL,2022-11-15,2022-12-07,ACTUAL,,,,2022-11-15,2022-12-07,ACTUAL,2018-08-27,ACTUAL,2018-08-27,2022-11,2022-11-30,2020-12-22,ACTUAL,2020-12-22,2020-12-22,ACTUAL,2020-12-22,,INTERVENTIONAL,,"This population is designated as the Safety Analysis Set, which is comprised of all subjects that were randomized and received study drug. They are grouped based on what they received, not what they were randomized to receive.",Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease,"A Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease",COMPLETED,,PHASE3,148.0,ACTUAL,"Otonomy, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,INDUSTRY,,,,,,,2020,1.0
NCT02933801,,2016-10-13,,,2024-03-11,2016-10-13,2016-10-14,ESTIMATED,,,,,,,2024-03-11,2024-03-13,ACTUAL,2017-03-31,ACTUAL,2017-03-31,2024-03,2024-03-31,2023-11-15,ACTUAL,2023-11-15,2021-06-28,ACTUAL,2021-06-28,,INTERVENTIONAL,,,ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents.,ODM-201 Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Non-progressive Disease After Subsequent Treatment With a Taxane: A Multicenter Randomized Double-blind Placebo-controlled Phase II Trial.,TERMINATED,,PHASE2,92.0,ACTUAL,Swiss Group for Clinical Cancer Research,,2.0,,Decision Board no further financial support after 3 years of follow-up as remaining patients in follow-up phase would not relevantly change the endpoints.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 14:13:07.075647,2024-10-15 14:13:07.075647,OTHER,,,,,,,2023,0.0
NCT04274452,,2020-02-14,,,2020-09-11,2020-02-17,2020-02-18,ACTUAL,,,,,,,2020-09-11,2020-09-14,ACTUAL,2020-06-29,ACTUAL,2020-06-29,2020-09,2020-09-30,2021-09-01,ESTIMATED,2021-09-01,2021-09-01,ESTIMATED,2021-09-01,,INTERVENTIONAL,ADVANCE2,,A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP),"A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia (ITP)",WITHDRAWN,,PHASE3,0.0,ACTUAL,argenx,,2.0,,The ARGX-113-1908 study will be replaced by a similar design with a subcutaneous formulation (ARGX-113-2004),,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 14:13:07.075647,2024-10-15 14:13:07.075647,INDUSTRY,,,,,,,2021,0.0
NCT04707469,,2021-01-12,2024-03-05,,2024-03-05,2021-01-12,2021-01-13,ACTUAL,2024-03-05,2024-04-03,ACTUAL,,,,2024-03-05,2024-04-03,ACTUAL,2021-01-15,ACTUAL,2021-01-15,2024-02,2024-02-29,2023-03-08,ACTUAL,2023-03-08,2023-03-07,ACTUAL,2023-03-07,,INTERVENTIONAL,PIONEER PLUS,Full analysis set (FAS) included all randomised participants.,Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes,Efficacy and Safety of Once-daily Oral Semaglutide 25 mg and 50 mg Compared With 14 mg in Subjects With Type 2 Diabetes,COMPLETED,,PHASE3,1606.0,ACTUAL,Novo Nordisk A/S,,3.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,INDUSTRY,,,,,,,2023,1.0
NCT02909335,,2016-09-09,,,2022-12-13,2016-09-16,2016-09-21,ESTIMATED,,,,,,,2022-12-13,2022-12-14,ACTUAL,2016-11,,2016-11-30,2022-12,2022-12-31,2021-11,ESTIMATED,2021-11-30,2021-11,ESTIMATED,2021-11-30,,INTERVENTIONAL,FOREVER,,"De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study","De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study",WITHDRAWN,,PHASE3,0.0,ACTUAL,Rennes University Hospital,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,OTHER,,,,,,,2021,0.0
NCT03325816,,2017-10-26,2021-01-24,,2021-02-22,2017-10-26,2017-10-30,ACTUAL,2021-02-22,2021-03-16,ACTUAL,,,,2021-02-22,2021-03-16,ACTUAL,2017-11-20,ACTUAL,2017-11-20,2021-02,2021-02-28,2020-08-11,ACTUAL,2020-08-11,2019-03-28,ACTUAL,2019-03-28,,INTERVENTIONAL,,,Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer,Phase I/II Trial of Anti-PD-1 Checkpoint Inhibitor Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer,COMPLETED,,PHASE1/PHASE2,9.0,ACTUAL,Georgetown University,,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,OTHER,,,,,,,2020,1.0
NCT03933410,,2019-04-29,,2022-01-20,2022-01-20,2019-04-29,2019-05-01,ACTUAL,,,,2022-01-20,2022-01-25,ACTUAL,2022-01-20,2022-01-25,ACTUAL,2019-09-17,ACTUAL,2019-09-17,2022-01,2022-01-31,2021-03-02,ACTUAL,2021-03-02,2021-02-02,ACTUAL,2021-02-02,,INTERVENTIONAL,UNLOCKED,,"UNLOCKED: A Phase 2, Open-label Trial With KB195 in Subjects With a Urea Cycle Disorder","A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of KB195 in Subjects With A Urea Cycle Disorder With Inadequate Control on Standard of Care",TERMINATED,,PHASE2,13.0,ACTUAL,Kaleido Biosciences,,1.0,,"Kaleido Biosciences, Inc. closed the K020-218 trial due to business reasons, and not due to any safety concerns.",f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,INDUSTRY,,,,,,,2021,0.0
NCT04097821,,2019-09-17,,,2024-09-19,2019-09-19,2019-09-20,ACTUAL,,,,,,,2024-09-19,2024-09-23,ACTUAL,2019-09-26,ACTUAL,2019-09-26,2024-09,2024-09-30,2024-08-28,ACTUAL,2024-08-28,2023-05-03,ACTUAL,2023-05-03,,INTERVENTIONAL,ADORE,,Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients,"A Randomized, Open-label, Phase I/II Open Platform Study Evaluating Safety and Efficacy of Novel Ruxolitinib Combinations in Myelofibrosis Patients",COMPLETED,,PHASE1/PHASE2,45.0,ACTUAL,Novartis,,14.0,,,f,,,,t,f,f,,,,,,,,https://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.",2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,INDUSTRY,,,,,,,2024,0.0
NCT04236440,,2020-01-21,,,2022-08-04,2020-01-21,2020-01-22,ACTUAL,,,,,,,2022-08-04,2022-08-08,ACTUAL,2020-02-04,ACTUAL,2020-02-04,2022-08,2022-08-31,2021-06-24,ACTUAL,2021-06-24,2021-05-06,ACTUAL,2021-05-06,,INTERVENTIONAL,KOALA,,Study on the Safety of Drug BAY2586116 and How it Works in Patients With Obstructive Sleep Apnea (a Sleep Disorder Caused by the Narrowing and Collapse of the Airway During Sleep) Including the Blood Level of the Drug and Effect of Its Doses and Routes of Administration,"Proof-of-mechanism Single-center, Randomized, Double-blind, Placebo-controlled 2-way Crossover Study to Investigate Pharmacodynamics, Safety, Tolerability and Exposure of BAY 2586116 (Part A) and an Open-label Comparison of Different Application Modes for Single Nasal/Pharyngeal Dose Administrations (Part B and Part C) in 12 Participants With Obstructive Sleep Apnea",COMPLETED,,PHASE2,14.0,ACTUAL,Bayer,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,"Availability of this study's data will be later determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,INDUSTRY,,,,,,,2021,1.0
NCT04648189,,2020-11-13,,,2023-10-17,2020-11-23,2020-12-01,ACTUAL,,,,,,,2023-10-17,2023-10-19,ACTUAL,2022-01-01,ESTIMATED,2022-01-01,2023-10,2023-10-31,2022-09-19,ACTUAL,2022-09-19,2022-09-19,ACTUAL,2022-09-19,,INTERVENTIONAL,,,Cetuxibab to Reduce Circulating Tumor Cells in Early Stage NSCLC,Are Anti-EGFR Monoclonal Antibodies the Magic Bullets That Remove Circulating EGFR+EpCAM+ Tumor Cells in Patients With Non-small Cell Lung Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,The Netherlands Cancer Institute,,1.0,,One of the participating specialties has decided to no longer cooperate in this research,f,,,,f,f,f,,,f,,,,,,UNDECIDED,to be decided,2024-10-15 14:13:07.075647,2024-10-15 14:13:07.075647,OTHER,,,,,,,2022,0.0
NCT03347279,,2017-11-09,2021-09-07,,2021-10-29,2017-11-17,2017-11-20,ACTUAL,2021-10-29,2021-11-26,ACTUAL,,,,2021-10-29,2021-11-26,ACTUAL,2017-11-23,ACTUAL,2017-11-23,2021-10,2021-10-31,2020-11-12,ACTUAL,2020-11-12,2020-09-08,ACTUAL,2020-09-08,,INTERVENTIONAL,NAVIGATOR,,Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma,"A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)",COMPLETED,,PHASE3,1061.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,INDUSTRY,,,,,,,2020,1.0
NCT03803007,,2018-12-12,,,2021-10-05,2019-01-11,2019-01-14,ACTUAL,,,,,,,2021-10-05,2021-10-06,ACTUAL,2019-03-06,ACTUAL,2019-03-06,2021-10,2021-10-31,2021-09-27,ACTUAL,2021-09-27,2021-09-27,ACTUAL,2021-09-27,,INTERVENTIONAL,ACTIMIS,,Acute Ischemic Stroke Interventional Study,"Randomized, Double Blind, Multi Center, Multinational, Placebo Controlled, Single Parallel Escalating Dose Safety and Efficacy Study of ACT017 Used as an Add on Therapy on Top of Standard of Care of Acute Ischemic Stroke",COMPLETED,,PHASE1/PHASE2,160.0,ACTUAL,Acticor Biotech,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,INDUSTRY,,,,,,,2021,1.0
NCT04042623,,2019-07-31,2021-11-30,,2022-01-18,2019-07-31,2019-08-02,ACTUAL,2022-01-18,2022-02-10,ACTUAL,,,,2022-01-18,2022-02-10,ACTUAL,2019-11-27,ACTUAL,2019-11-27,2022-01,2022-01-31,2020-08-01,ACTUAL,2020-08-01,2020-08-01,ACTUAL,2020-08-01,,INTERVENTIONAL,,,Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy,An Open-Label Phase 2a Study to Evaluate the Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy,TERMINATED,,PHASE2,1.0,ACTUAL,"Aravive, Inc.","After enrollment of one subject, the study was paused due to the COVID-19 pandemic. Subsequently, the sponsor terminated the study due to a change in sponsor priorities.",1.0,,Business reasons,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,INDUSTRY,,,,,,,2020,0.0
NCT04478695,,2020-07-16,2023-08-11,,2023-08-11,2020-07-16,2020-07-21,ACTUAL,2023-08-11,2024-03-08,ACTUAL,,,,2023-08-11,2024-03-08,ACTUAL,2020-09-29,ACTUAL,2020-09-29,2023-06,2023-06-30,2020-10-23,ACTUAL,2020-10-23,2020-10-23,ACTUAL,2020-10-23,,INTERVENTIONAL,,The study was terminated with only 1 participant enrolled into Cohort 1 (0 participants were enrolled into Cohort 2). No data are reported here to maintain participant confidentiality.,Study of AMG 330 in Combination With Pembrolizumab in Adult With Relapsed or Refractory Acute Myeloid Leukemia,"A Phase 1b Study Assessing Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 330 cIV in Combination With Pembrolizumab in Adult Subjects With Relapsed or Refractory Acute Myeloid Leukemia",TERMINATED,,PHASE1,1.0,ACTUAL,Amgen,"This study was early terminated, leading to a small number of participants enrolled and analyzed.",2.0,,Amgen Decision,f,,,,,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,INDUSTRY,,,,,,,2020,0.0
NCT05189977,,2021-10-22,,,2024-01-22,2021-12-23,2022-01-13,ACTUAL,,,,,,,2024-01-22,2024-01-23,ACTUAL,2022-09-07,ACTUAL,2022-09-07,2024-01,2024-01-31,2023-08-03,ACTUAL,2023-08-03,2023-08-03,ACTUAL,2023-08-03,,INTERVENTIONAL,,,A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline,"A Phase 1, Open-label, Fixed-sequence, Cross-over Trial to Assess the Effects of a Single Dose of Prazosin or Propranolol in the Presence of Brexpiprazole/Sertraline at Steady-state on Blood Pressure",TERMINATED,,PHASE1,34.0,ACTUAL,"Otsuka Pharmaceutical Development & Commercialization, Inc.",,2.0,,"The decision to terminate the trial early was not based on safety concerns. The trial was terminated early due to some implausible blood pressure values being captured, which was the primary endpoint of the study.",f,,,,f,t,f,,,,,,,,,,,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,INDUSTRY,,,,,,,2023,0.0
NCT01556776,,2012-03-14,,,2021-12-16,2012-03-15,2012-03-16,ESTIMATED,,,,,,,2021-12-16,2022-01-05,ACTUAL,2012-07-20,ACTUAL,2012-07-20,2021-08,2021-08-31,2021-01-14,ACTUAL,2021-01-14,2016-03,ACTUAL,2016-03-31,,INTERVENTIONAL,,,A Study of Lenalidomide Maintenance for High-risk Patients With CLL Following First-line Therapy,"CLLM1-Protocol of the German CLL-Study Group (GCLLSG) A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for High-risk Patients With Chronic Lymphocytic Leukemia Following First-line Therapy",COMPLETED,,PHASE3,89.0,ACTUAL,German CLL Study Group,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,OTHER,,,,,,,2021,1.0
NCT02725593,,2016-03-29,2020-10-02,,2022-01-28,2016-03-29,2016-04-01,ESTIMATED,2020-11-10,2020-12-02,ACTUAL,,,,2022-01-28,2022-02-23,ACTUAL,2016-06-22,ACTUAL,2016-06-22,2022-01,2022-01-31,2020-04-06,ACTUAL,2020-04-06,2020-04-06,ACTUAL,2020-04-06,,INTERVENTIONAL,,,Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years,"A 24 Week, Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial With a 28 Week Long Term Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 10 mg in T2DM Patients Aged 10-24 Years",COMPLETED,,PHASE3,72.0,ACTUAL,AstraZeneca,,2.0,,,,,,,t,,,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,INDUSTRY,,,,,,,2020,1.0
NCT04556721,,2020-07-22,,,2021-09-10,2020-09-14,2020-09-21,ACTUAL,,,,,,,2021-09-10,2021-09-17,ACTUAL,2021-09-10,ACTUAL,2021-09-10,2021-09,2021-09-30,2021-09-10,ACTUAL,2021-09-10,2021-09-10,ACTUAL,2021-09-10,,INTERVENTIONAL,,,A Pharmacokinetic Study of Sugammadex in Dialysis Patients,Assessing the Post-Surgical Trend of Sugammadex Concentration in Dialysis Dependent Patients,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Pittsburgh,,1.0,,Difficulty and lack of recruitment of the patients,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,OTHER,,,,,,,2021,0.0
NCT04909502,,2021-05-14,,,2022-10-19,2021-05-27,2021-06-01,ACTUAL,,,,,,,2022-10-19,2022-10-21,ACTUAL,2021-10-19,ACTUAL,2021-10-19,2022-04,2022-04-30,2024-04,ESTIMATED,2024-04-30,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,"Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Relapsing Forms of Multiple Sclerosis","A Phase IIa, Open-label, Multicentre Dose-Finding Trial in Patients With Relapsing Forms of Multiple Sclerosis (RMS) to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101",SUSPENDED,,PHASE2,50.0,ESTIMATED,Emerald Health Pharmaceuticals,,2.0,,"Temporary recruitment pause to re-assess the protocol design, specifically the eligibility criteria",f,,,,,t,f,,,t,,,,,,,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,INDUSTRY,,,,,,,2024,0.0
NCT04139577,,2019-10-23,,,2024-03-06,2019-10-23,2019-10-25,ACTUAL,,,,,,,2024-03-06,2024-03-07,ACTUAL,2021-06-18,ACTUAL,2021-06-18,2024-03,2024-03-31,2023-01-05,ACTUAL,2023-01-05,2022-08-03,ACTUAL,2022-08-03,,INTERVENTIONAL,,,FMT In High-Risk Acute GVHD After ALLO HCT,Fecal Microbiota Transplantation (FMT) in for the Treatment of High-Risk Acute Graft-Versus-Host Disease (GVHD) After Allogeneic Hematopoietic Cell Transplantation (HCT),COMPLETED,,PHASE1,10.0,ACTUAL,Massachusetts General Hospital,,1.0,,,f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,Contact the Partners Innovations team at http://www.partners.org/innovation,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to the Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,OTHER,,,,,,,2023,0.0
NCT03371862,,2017-10-25,,,2020-08-12,2017-12-06,2017-12-13,ACTUAL,,,,,,,2020-08-12,2020-08-14,ACTUAL,2017-10-20,ACTUAL,2017-10-20,2020-08,2020-08-31,2020-09-30,ESTIMATED,2020-09-30,2020-08-06,ACTUAL,2020-08-06,,INTERVENTIONAL,SLIPS,,Liraglutide on Decreasing Parenteral Support in Short Bowel Patients (SLIPS),"Pilot Study of the GLP-1 Agonist, Liraglutide, on Decreasing Parenteral Support Requirements in Short Bowel Patients.",WITHDRAWN,,PHASE2,0.0,ACTUAL,Imperial College London,,1.0,,No participants recruited. Not able to recruit due to COVID 19.,f,,,,f,f,f,,,f,,,,,,UNDECIDED,,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,OTHER,,,,,,,2020,0.0
NCT02647892,,2015-12-17,,,2023-08-16,2016-01-05,2016-01-06,ESTIMATED,,,,,,,2023-08-16,2023-08-21,ACTUAL,2016-01-08,ACTUAL,2016-01-08,2023-08,2023-08-31,2021-11-05,ACTUAL,2021-11-05,2021-11-05,ACTUAL,2021-11-05,,INTERVENTIONAL,,,Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia,Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia,TERMINATED,,PHASE4,70.0,ACTUAL,University of Nebraska,,4.0,,"IRB protocol administratively closed, Continuing Review or Study Completion Report not submitted",f,,,,f,,,,,,,,,,,NO,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER,,,,,,,2021,0.0
NCT04493216,,2020-07-10,2023-09-05,,2024-05-29,2020-07-27,2020-07-30,ACTUAL,2023-10-26,2023-11-18,ACTUAL,,,,2024-05-29,2024-06-26,ACTUAL,2020-11-18,ACTUAL,2020-11-18,2024-05,2024-05-31,2023-05-29,ACTUAL,2023-05-29,2022-09-05,ACTUAL,2022-09-05,,INTERVENTIONAL,DOMINO,,A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults,"A Phase IIb, Randomized, Partially Blind, Active Controlled, Dose-range Finding Study of GSK3640254 Compared to a Reference Arm of Dolutegravir, Each in Combination With Nucleoside Reverse Transcriptase Inhibitors, in HIV-1 Infected Antiretroviral Treatment-naive Adults",TERMINATED,,PHASE2,161.0,ACTUAL,ViiV Healthcare,,4.0,,Company decision to stop compound development. The decision is not based on any safety or efficacy concerns. It reflects the company strategy for portfolio progression.,f,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,INDUSTRY,,,,,,,2023,0.0
NCT04465877,,2020-07-01,2022-02-08,,2022-04-28,2020-07-09,2020-07-10,ACTUAL,2022-04-28,2023-01-27,ACTUAL,,,,2022-04-28,2023-01-27,ACTUAL,2020-06-15,ACTUAL,2020-06-15,2022-04,2022-04-30,2021-02-17,ACTUAL,2021-02-17,2021-02-17,ACTUAL,2021-02-17,,INTERVENTIONAL,,,"Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes","Single-blind, Randomized, Placebo-controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JTT-662 Administered for 28 Days in Subjects With Type 2 Diabetes Mellitus on Metformin Monotherapy",COMPLETED,,PHASE1,37.0,ACTUAL,Akros Pharma Inc.,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:18:36.014807,2024-10-15 00:18:36.014807,INDUSTRY,,,,,,,2021,1.0
NCT02961114,,2016-11-08,,,2021-01-09,2016-11-09,2016-11-10,ESTIMATED,,,,,,,2021-01-09,2021-01-12,ACTUAL,2019-11-01,ACTUAL,2019-11-01,2021-01,2021-01-31,2023-07,ESTIMATED,2023-07-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,SVF-BPN,,Use of Autologous Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Symptomatic Benign Prostate Hypertrophy,Use of Autologous Adipose-Derived Stem/Stromal Cells In Symptomatic Benign Prostate Hypertrophy,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Healeon Medical Inc,,3.0,,COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform,f,,,,t,f,f,,,,,,,,,YES,Annual Data Update to All Collaborators,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,INDUSTRY,,,,,,,2023,0.0
NCT03582033,,2018-06-12,,,2023-11-29,2018-07-03,2018-07-10,ACTUAL,,,,,,,2023-11-29,2023-12-06,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2023-11,2023-11-30,2023-11-09,ACTUAL,2023-11-09,2023-11-09,ACTUAL,2023-11-09,,INTERVENTIONAL,,,A Safety Study of SEA-BCMA in Patients With Multiple Myeloma,A Phase 1 Study of SEA-BCMA in Patients With Relapsed or Refractory Multiple Myeloma,TERMINATED,,PHASE1,83.0,ACTUAL,Seagen Inc.,,3.0,,Study closed due to portfolio prioritization,f,,,,f,t,f,,,,,,,,,,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,INDUSTRY,,,,,,,2023,0.0
NCT02998905,,2016-11-25,,,2020-03-18,2016-12-16,2016-12-21,ESTIMATED,,,,,,,2020-03-18,2020-03-20,ACTUAL,2017-04-26,ACTUAL,2017-04-26,2020-03,2020-03-31,2020-02-18,ACTUAL,2020-02-18,2019-10-31,ACTUAL,2019-10-31,,INTERVENTIONAL,NASPAF-ICH,,NOACs for Stroke Prevention in Patients With Atrial Fibrillation and Previous ICH,Non-Vitamin K Antagonist Oral Anticoagulants for Stroke Prevention in Patients With Atrial Fibrillation and Previous Intracerebral Hemorrhage Study,COMPLETED,,PHASE2,30.0,ACTUAL,Population Health Research Institute,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,OTHER,,,,,,,2020,0.0
NCT03645525,,2018-08-16,,,2023-12-27,2018-08-23,2018-08-24,ACTUAL,,,,,,,2023-12-27,2023-12-29,ACTUAL,2019-12-01,ACTUAL,2019-12-01,2023-12,2023-12-31,2023-04-01,ESTIMATED,2023-04-01,2022-10-30,ESTIMATED,2022-10-30,,INTERVENTIONAL,IUMTB,,Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD),Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD),WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Children's Hospital of Fudan University,,2.0,,The certification of cell-based treatment in the settings need to be updated.,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,OTHER,,,,,,,2023,0.0
NCT05382819,,2022-04-04,,,2023-08-22,2022-05-18,2022-05-19,ACTUAL,,,,,,,2023-08-22,2023-08-24,ACTUAL,2022-05-16,ACTUAL,2022-05-16,2023-08,2023-08-31,2023-08-11,ACTUAL,2023-08-11,2023-02-08,ACTUAL,2023-02-08,,INTERVENTIONAL,,,"A Safety, Tolerability and Preliminary Efficacy Study of FRTX-02 Capsules in Healthy Subjects and Subjects With Atopic Dermatitis","A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Single and Multiple Ascending Doses of FRTX-02 in Healthy Subjects and Subjects With Atopic Dermatitis",TERMINATED,,PHASE1,89.0,ACTUAL,"Fresh Tracks Therapeutics, Inc.",,6.0,,Business Decision,f,,,,,f,f,,,f,,,,,,NO,,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,INDUSTRY,,,,,,,2023,0.0
NCT02888041,,2016-08-24,,,2024-08-27,2016-08-29,2016-09-02,ESTIMATED,,,,,,,2024-08-27,2024-08-28,ACTUAL,2016-12,ACTUAL,2016-12-31,2024-08,2024-08-31,2022-04-23,ACTUAL,2022-04-23,2022-04-23,ACTUAL,2022-04-23,,INTERVENTIONAL,RE-DINO,,"Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term?","Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term?",TERMINATED,,PHASE3,160.0,ACTUAL,"University Hospital, Limoges",,2.0,,Not enough patients,f,,,,t,,,,,,,,,,,NO,,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,OTHER,,,,,,,2022,0.0
NCT03245840,,2017-08-08,2022-09-27,,2022-11-10,2017-08-08,2017-08-10,ACTUAL,2022-11-10,2022-12-07,ACTUAL,,,,2022-11-10,2022-12-07,ACTUAL,2017-10-05,ACTUAL,2017-10-05,2022-11,2022-11-30,2022-04-26,ACTUAL,2022-04-26,2022-04-26,ACTUAL,2022-04-26,,INTERVENTIONAL,,The safety analysis set (SAS) consisted of all participants who received at least 1 dose of BOS.,Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE),"A Phase 3, Multicenter, Open-label Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Subjects With Eosinophilic Esophagitis (EoE)",TERMINATED,,PHASE3,133.0,ACTUAL,Takeda,The study was discontinued prematurely as per sponsor's decision.,1.0,,Sponsor decision,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,INDUSTRY,,,,,,,2022,0.0
NCT03751657,,2018-11-16,2020-12-11,,2021-03-05,2018-11-21,2018-11-23,ACTUAL,2021-01-28,2021-02-01,ACTUAL,,,,2021-03-05,2021-04-02,ACTUAL,2018-11-29,ACTUAL,2018-11-29,2021-03,2021-03-31,2020-01-17,ACTUAL,2020-01-17,2019-12-16,ACTUAL,2019-12-16,,INTERVENTIONAL,,Full analysis set (FAS) included all randomised participants.,A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine (100 Units/mL) Once a Day in People With Type 2 Diabetes.,"An Investigational Trial Comparing the Efficacy and Safety of Once Weekly NNC0148-0287 C (Insulin 287) Versus Once Daily Insulin Glargine, Both in Combination With Metformin, With or Without DPP-4 Inhibitors, in Insulin naïve Subjects With Type 2 Diabetes Mellitus",COMPLETED,,PHASE2,247.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,INDUSTRY,,,,,,,2020,1.0
NCT03952325,,2019-05-14,,,2021-07-26,2019-05-14,2019-05-16,ACTUAL,,,,,,,2021-07-26,2021-07-30,ACTUAL,2019-07-09,ACTUAL,2019-07-09,2021-07,2021-07-31,2021-06-23,ACTUAL,2021-06-23,2021-06-23,ACTUAL,2021-06-23,,INTERVENTIONAL,CONTESSA TRIO,,Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Triple-Negative MBC and Tesetaxel Monotherapy in Patients With HER2-Negative MBC,"A Multicenter, Phase 2 Study of Tesetaxel Plus Three Different PD-(L)1 Inhibitors in Patients With Triple-Negative, Locally Advanced or Metastatic Breast Cancer and Tesetaxel Monotherapy in Elderly and Non-Elderly Adult Patients With HER2-Negative, Locally Advanced or Metastatic Breast Cancer",TERMINATED,,PHASE2,294.0,ACTUAL,"Odonate Therapeutics, Inc.",,5.0,,The Sponsor has discontinued the development of tesetaxel,f,,,,t,t,f,,,,,,,,,,,2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,INDUSTRY,,,,,,,2021,0.0
NCT03180294,,2017-06-06,2022-02-10,,2022-02-10,2017-06-06,2017-06-08,ACTUAL,2022-02-10,2022-03-08,ACTUAL,,,,2022-02-10,2022-03-08,ACTUAL,2017-05-31,ACTUAL,2017-05-31,2022-02,2022-02-28,2021-02-22,ACTUAL,2021-02-22,2021-02-22,ACTUAL,2021-02-22,,INTERVENTIONAL,,Eligible participants,Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer,Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women With Breast or Gynecologic Cancer,COMPLETED,,PHASE2,230.0,ACTUAL,NRG Oncology,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER,,,,,,,2021,1.0
NCT02901067,,2016-01-24,2022-05-20,,2023-04-25,2016-09-14,2016-09-15,ESTIMATED,2023-04-25,2023-04-27,ACTUAL,,,,2023-04-25,2023-04-27,ACTUAL,2017-02-03,ACTUAL,2017-02-03,2023-04,2023-04-30,2021-08-01,ACTUAL,2021-08-01,2021-05-24,ACTUAL,2021-05-24,,INTERVENTIONAL,STAT,,STAT-STatin and Aspirin in Trauma,"STAT (STatins and Aspirin in Trauma) Trial: A Phase II, Pragmatic, Prospective, Randomized, Double-blind, Adaptive Clinical Trial Examining the Efficacy of Statins and Aspirin in the Reduction of Acute Lung Injury and Venous Thromboembolism in Patients With Fibrinolysis Shutdown",TERMINATED,,PHASE2,43.0,ACTUAL,Denver Health and Hospital Authority,,2.0,,COVID-19 pandemic and high proportion of patients meeting exclusion criteria.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,OTHER,,,,,,,2021,0.0
NCT04896632,,2021-05-12,,,2023-09-26,2021-05-20,2021-05-21,ACTUAL,,,,,,,2023-09-26,2023-09-28,ACTUAL,2021-05-13,ACTUAL,2021-05-13,2023-09,2023-09-30,2022-11-24,ACTUAL,2022-11-24,2022-11-24,ACTUAL,2022-11-24,,INTERVENTIONAL,,,"Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants","A Randomized, Participant- and Investigator-blinded, Placebo-controlled, Single Ascending Dose and Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants",TERMINATED,,PHASE1,64.0,ACTUAL,Novartis,,2.0,,Sponsor's decision.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,INDUSTRY,,,,,,,2022,0.0
NCT04332523,,2020-04-01,,,2022-06-09,2020-04-01,2020-04-02,ACTUAL,,,,,,,2022-06-09,2022-06-13,ACTUAL,2020-08-17,ACTUAL,2020-08-17,2022-06,2022-06-30,2022-03-16,ACTUAL,2022-03-16,2022-03-16,ACTUAL,2022-03-16,,INTERVENTIONAL,,,A Study of JNJ-53718678 in Participants With Hepatic Impairment,"A Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on the Pharmacokinetics of JNJ-53718678",TERMINATED,,PHASE1,25.0,ACTUAL,"Janssen Research & Development, LLC",,4.0,,A strategic decision was made to discontinue the study. The decision was not based on a safety concern.,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,INDUSTRY,,,,,,,2022,0.0
NCT02972294,,2016-11-21,,,2022-07-28,2016-11-21,2016-11-23,ESTIMATED,,,,,,,2022-07-28,2022-08-02,ACTUAL,2017-03-31,ACTUAL,2017-03-31,2022-07,2022-07-31,2021-09-16,ACTUAL,2021-09-16,2021-09-16,ACTUAL,2021-09-16,,INTERVENTIONAL,HiFIT,,HiFIT Study : Hip Fracture: Iron and Tranexamic Acid,HiFIT Study: Interest of Intravenous Iron and Tranexamic Acid to Reduce Transfusion in Hip Fracture Patients,TERMINATED,,PHASE3,419.0,ACTUAL,"University Hospital, Angers",,4.0,,1year inclusion hold due to PV new fact (Monofer hold for risk revaluation) DSMB Interim analysis : 1treatment with important transfusion risk reduction/inclusions issues (COVID)/sites change of practice if study continue=\>stop inclusions,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER_GOV,,,,,,,2021,0.0
NCT02101385,,2014-03-21,2022-10-17,,2023-08-31,2014-03-28,2014-04-02,ESTIMATED,2023-08-31,2023-09-28,ACTUAL,,,,2023-08-31,2023-09-28,ACTUAL,2014-04-03,ACTUAL,2014-04-03,2023-08,2023-08-31,2022-09-09,ACTUAL,2022-09-09,2021-02-21,ACTUAL,2021-02-21,,INTERVENTIONAL,,This population includes all subjects who were enrolled and found eligible and evaluable for this trial.,Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer,A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients With Triple Negative Breast Cancer: Hoosier Oncology Group BRE12-158,COMPLETED,,PHASE2,193.0,ACTUAL,Hoosier Cancer Research Network,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,OTHER,,,,,,,2022,0.0
NCT03814798,,2019-01-22,,,2020-04-08,2019-01-22,2019-01-24,ACTUAL,,,,,,,2020-04-08,2020-04-10,ACTUAL,2019-12,ESTIMATED,2019-12-31,2020-04,2020-04-30,2020-09,ESTIMATED,2020-09-30,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,Study Evaluating IGSC 20% Flexible Dosing in Treatment-Experienced and Treatment-Naive Subjects With Primary Immunodeficiency,"A Multicenter, Randomized, Cross-over, Open-label Study to Evaluate IGSC 20% Flexible Dosing Including Daily Push Dosing In Treatment-Experienced Subjects With Primary Immunodeficiency (PI) and Evaluation of Loading/Maintenance IGSC 20% in Treatment-Naïve Subjects With PI",WITHDRAWN,,PHASE3,0.0,ACTUAL,Grifols Therapeutics LLC,,4.0,,"Due to the regulatory approval of the product in this indication, a large portion of the study becomes unnecessary.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,INDUSTRY,,,,,,,2020,0.0
NCT04247282,,2020-01-25,2023-06-24,,2024-06-20,2020-01-29,2020-01-30,ACTUAL,2023-07-19,2023-08-08,ACTUAL,,,,2024-06-20,2024-07-16,ACTUAL,2020-06-09,ACTUAL,2020-06-09,2024-06,2024-06-30,2023-06-12,ACTUAL,2023-06-12,2021-08-24,ACTUAL,2021-08-24,,INTERVENTIONAL,,Baseline characteristic data collected for one participant that was enrolled but not treated is reported here.,Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection,"A Sequential Window of Opportunity Trial of Anti-PD-L1/TGF-beta Trap (M7824 ) Alone and in Combination With TriAd Vaccine, and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection.",COMPLETED,,PHASE1/PHASE2,21.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,,f,,,,f,t,f,,,,,,Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.,,YES,All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. All large- scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,NIH,,,,,,,2023,1.0
NCT03459443,,2018-02-26,2022-03-28,,2023-08-17,2018-03-07,2018-03-09,ACTUAL,2022-08-09,2022-08-11,ACTUAL,,,,2023-08-17,2023-08-21,ACTUAL,2018-06-20,ACTUAL,2018-06-20,2023-08,2023-08-31,2021-03-29,ACTUAL,2021-03-29,2021-03-29,ACTUAL,2021-03-29,,INTERVENTIONAL,,All participants who received at least 1 dose of study drug during treatment period.,A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471,An Open-Label Phase 2 Proof-of-Concept Study in Patients With C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated With ACH-0144471,TERMINATED,,PHASE2,22.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,1.0,,The reason for terminating study early was inconclusive efficacy results. No safety findings were identified.,f,,,,f,t,f,,,,,,,,,YES,"Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.",2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,INDUSTRY,,,,,,,2021,0.0
NCT05086276,,2021-10-08,2023-03-30,,2023-04-20,2021-10-08,2021-10-20,ACTUAL,2023-04-20,2023-04-21,ACTUAL,,,,2023-04-20,2023-04-21,ACTUAL,2021-10-12,ACTUAL,2021-10-12,2023-04,2023-04-30,2022-12-30,ACTUAL,2022-12-30,2022-12-30,ACTUAL,2022-12-30,,INTERVENTIONAL,,"Full analysis set is defined as the subjects who met all inclusion criteria who received at least 1 dose of study drug. Note that 2 subjects who received FX-322 treatment were ultimately not included in the Full Analysis Set because, after they had been treated and as study assessments progressed, they were deemed to not meet the inclusion criteria for sensorineural hearing loss (SNHL) and were excluded from the FAS.",FX-322 in Adults With Acquired Sensorineural Hearing Loss,"A Phase 2, Prospective, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Multicenter Study to Evaluate the Efficacy of FX-322 Administered by Intratympanic Injection in Adults With Acquired Sensorineural Hearing Loss",COMPLETED,,PHASE2,142.0,ACTUAL,Frequency Therapeutics,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,INDUSTRY,,,,,,,2022,1.0
NCT04211922,,2019-12-23,,,2024-04-25,2019-12-23,2019-12-26,ACTUAL,,,,,,,2024-04-25,2024-04-26,ACTUAL,2020-01-21,ACTUAL,2020-01-21,2024-04,2024-04-30,2022-10-11,ACTUAL,2022-10-11,2022-10-11,ACTUAL,2022-10-11,,INTERVENTIONAL,,,Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib,"A Phase II, Multicenter, Single-arm Study to Evaluate Safety and Efficacy of Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib",TERMINATED,,PHASE2,4.0,ACTUAL,"Suzhou Zelgen Biopharmaceuticals Co.,Ltd",,1.0,,Sponsor R\&D Strategy Adjustment,f,,,,f,f,f,,,,,,,,,,,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,INDUSTRY,,,,,,,2022,0.0
NCT04410523,,2020-05-06,2023-07-18,2023-06-07,2024-06-17,2020-05-27,2020-06-01,ACTUAL,2023-07-18,2023-08-07,ACTUAL,,2023-06-13,ACTUAL,2024-06-17,2024-06-20,ACTUAL,2020-09-09,ACTUAL,2020-09-09,2024-06,2024-06-30,2022-09-06,ACTUAL,2022-09-06,2022-07-12,ACTUAL,2022-07-12,,INTERVENTIONAL,,,Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma,"A 12-week, Multicenter, Randomized, Double-blind, Parallel-arm, Placebo-controlled Study to Assess the Efficacy and Safety of CSJ117, When Added to Existing Asthma Therapy in Patients ≥ 18 Years of Age With Severe Uncontrolled Asthma.",TERMINATED,,PHASE2,335.0,ACTUAL,Novartis,,6.0,,Sponsor Desicion,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,INDUSTRY,,,,,,,2022,0.0
NCT04602221,,2020-10-16,2023-08-10,,2023-08-10,2020-10-20,2020-10-26,ACTUAL,2023-08-10,2024-03-12,ACTUAL,,,,2023-08-10,2024-03-12,ACTUAL,2020-12-01,ACTUAL,2020-12-01,2023-08,2023-08-31,2022-08-12,ACTUAL,2022-08-12,2022-08-01,ACTUAL,2022-08-01,,INTERVENTIONAL,,Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of Investigational medicinal product (IMP)/Placebo or ketamine.,"A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine","A Randomized, Placebo Controlled, Double-blind, Double-dummy Three-way Cross Over Trial to Investigate the Effect of BI 409306, BI 425809 and Lamotrigine on Ketamine-induced Cognitive Deficits in Healthy Male Subjects",COMPLETED,,PHASE1,40.0,ACTUAL,Boehringer Ingelheim,,18.0,,,f,,,,f,t,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,INDUSTRY,,,,,,,2022,1.0
NCT03532425,,2018-05-09,2022-09-19,,2022-11-21,2018-05-09,2018-05-22,ACTUAL,2022-11-21,2022-12-14,ACTUAL,,,,2022-11-21,2022-12-14,ACTUAL,2018-10-29,ACTUAL,2018-10-29,2022-11,2022-11-30,2020-09-03,ACTUAL,2020-09-03,2020-08-03,ACTUAL,2020-08-03,,INTERVENTIONAL,,,B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults,"Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate to Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Virologically Suppressed Adults",TERMINATED,,PHASE4,28.0,ACTUAL,University of Alberta,,2.0,,Difficulties enrolling participants,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,OTHER,,,,,,,2020,0.0
NCT03756285,,2018-11-19,2021-05-07,,2021-06-29,2018-11-26,2018-11-28,ACTUAL,2021-06-29,2021-07-19,ACTUAL,,,,2021-06-29,2021-07-19,ACTUAL,2018-12-11,ACTUAL,2018-12-11,2021-06,2021-06-30,2020-05-07,ACTUAL,2020-05-07,2020-05-07,ACTUAL,2020-05-07,,INTERVENTIONAL,SATELLITE,,Safety and Tolerability Study of AZD4831 in Patients With Heart Failure.,"A Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicentre, Phase 2a Study to Assess Target Engagement, Safety and Tolerability of AZD4831 in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)",TERMINATED,,PHASE2,41.0,ACTUAL,AstraZeneca,"Due to premature study termination, the statistical assumptions for the study design according to the Clinical Study Protocol could not be fulfilled, therefore, no statistical conclusions can be made based on primary or secondary efficacy objectives. Statistical significance could not be evaluated for any efficacy objectives and the p-values presented are viewed as nominal.",2.0,,A decision was made to stop the study early when AstraZeneca evaluated the available data and it was considered that completing the study would provide limited additional information and unlikely to change the study conclusions.,f,,,,f,t,f,,,f,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,INDUSTRY,,,,,,,2020,0.0
NCT02757443,,2016-04-13,,,2021-06-28,2016-04-27,2016-05-02,ESTIMATED,,,,,,,2021-06-28,2021-07-01,ACTUAL,2016-06,ACTUAL,2016-06-30,2021-06,2021-06-30,2021-05,ACTUAL,2021-05-31,2021-04,ACTUAL,2021-04-30,,INTERVENTIONAL,PRISE,,Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients,Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients: a Single-center Randomised Double-blind Placebo-controlled Exploratory Pilot Clinical Trial,COMPLETED,,PHASE3,120.0,ACTUAL,Meshalkin Research Institute of Pathology of Circulation,,2.0,,,f,,,,t,,,,,,,,,,,YES,,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,NETWORK,,,,,,,2021,0.0
NCT05147415,,2021-11-24,,,2022-12-09,2021-11-24,2021-12-07,ACTUAL,,,,,,,2022-12-09,2022-12-13,ACTUAL,2021-11-11,ACTUAL,2021-11-11,2022-12,2022-12-31,2022-12-09,ACTUAL,2022-12-09,2022-12-09,ACTUAL,2022-12-09,,INTERVENTIONAL,,,Study of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO),"A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding, Multi-center, 36-week Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Hypothalamic Obesity",WITHDRAWN,,PHASE2,0.0,ACTUAL,Saniona,,4.0,,Due to financial considerations Sponsor is unable to complete the trial and assess the planned objectives/endpoints. No subjects have been randomized to treatment in the clinical trial and the decision therefore has no safety concern for patients,f,,,,t,t,f,,,,,,Following completion of Tesomet clinical development,,,YES,The Sponsor will consider requests from qualified researchers for access to TM008 study materials,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,INDUSTRY,,,,,,,2022,0.0
NCT02908685,,2016-09-19,2020-08-27,,2024-04-01,2016-09-19,2016-09-21,ESTIMATED,2021-05-20,2021-06-15,ACTUAL,,,,2024-04-01,2024-04-24,ACTUAL,2016-10-19,ACTUAL,2016-10-19,2024-03,2024-03-31,2023-10-02,ACTUAL,2023-10-02,2019-09-06,ACTUAL,2019-09-06,,INTERVENTIONAL,SUNFISH,,"A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy (SMA) Participants","A Two Part Seamless, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy Patients",COMPLETED,,PHASE2,231.0,ACTUAL,Hoffmann-La Roche,,6.0,,,t,,,,,,,,,,,,,,,,,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,INDUSTRY,,NCT04256265,APPROVED_FOR_MARKETING,,,,2023,1.0
NCT03832114,,2019-01-28,2022-04-22,,2024-01-22,2019-02-04,2019-02-06,ACTUAL,2022-06-13,2022-07-08,ACTUAL,,,,2024-01-22,2024-01-30,ACTUAL,2019-02-20,ACTUAL,2019-02-20,2024-01,2024-01-31,2021-04-23,ACTUAL,2021-04-23,2021-04-23,ACTUAL,2021-04-23,,INTERVENTIONAL,,"For all analysis sets, patients were analyzed according to study drug received for Cohort A and B. Safety analysis set included all patients that received any study drug. PK analysis set included all patients with available PK data and no protocol deviations with relevant impact on PK data.",Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted,"An Open-label, Non-randomized Study on Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of LNP023 in Two Patient Populations With C3 Glomerulopathy",COMPLETED,,PHASE2,27.0,ACTUAL,Novartis,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,INDUSTRY,,,,,,,2021,1.0
NCT04382625,,2020-04-14,,,2021-02-04,2020-05-08,2020-05-11,ACTUAL,,,,,,,2021-02-04,2021-02-05,ACTUAL,2020-10,ESTIMATED,2020-10-31,2020-05,2020-05-31,2022-06-01,ESTIMATED,2022-06-01,2022-01-01,ESTIMATED,2022-01-01,,INTERVENTIONAL,,,Hydroxychloroquine in SARS-CoV-2 (COVID-19) Pneumonia Trial,Hydroxychloroquine in SARS-CoV-2 (COVID-19) Pneumonia Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,Kootenai Health,,2.0,,"Secondary to other study results, suspended for a scientific review",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,OTHER,,,,,,,2022,0.0
NCT04614025,,2020-11-02,,,2024-08-28,2020-11-02,2020-11-03,ACTUAL,,,,,,,2024-08-28,2024-08-29,ACTUAL,2020-10-19,ACTUAL,2020-10-19,2024-08,2024-08-31,2023-02-07,ACTUAL,2023-02-07,2021-08-04,ACTUAL,2021-08-04,,INTERVENTIONAL,,,Open-label Multicenter Study to Evaluate the Efficacy of PLX-PAD for the Treatment of COVID-19,"A Randomized, Controlled, Multicenter, Parallel-Group Phase IIa Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of Severe COVID-19",TERMINATED,,PHASE2,23.0,ACTUAL,Pluristem Ltd.,,2.0,,"The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients.",f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,INDUSTRY,,,,,,,2023,0.0
NCT04857840,,2021-04-20,,,2023-01-13,2021-04-20,2021-04-23,ACTUAL,,,,,,,2023-01-13,2023-01-17,ACTUAL,2021-08-05,ACTUAL,2021-08-05,2023-01,2023-01-31,2023-01-09,ACTUAL,2023-01-09,2023-01-09,ACTUAL,2023-01-09,,INTERVENTIONAL,REFRESH,,Randomized Study of Extended Treatment With Firibastat in Treatment-Resistant Hypertension (REFRESH),"A Phase 3, Double-blind, Placebo-controlled and Open-label Efficacy and Long-term Safety Study of Firibastat (QGC001) Administered Orally, Once Daily, for Up to 48 Weeks in Patients With Difficult-to-treat/Resistant Hypertension.",TERMINATED,,PHASE3,419.0,ACTUAL,Quantum Genomics SA,,2.0,,No Efficacy demonstrated inn the QGC001-3QG1 study,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,INDUSTRY,,,,,,,2023,0.0
NCT05966584,,2023-07-20,2024-08-07,,2024-08-07,2023-07-20,2023-07-28,ACTUAL,2024-08-07,2024-08-29,ACTUAL,,,,2024-08-07,2024-08-29,ACTUAL,2023-07-06,ACTUAL,2023-07-06,2024-08,2024-08-31,2024-08-02,ACTUAL,2024-08-02,2024-08-02,ACTUAL,2024-08-02,,INTERVENTIONAL,,,A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer,RETENTION: An Open-Label Phase 2 Trial of InteRlEukin (5) InhibiTion for the prEveNTION of Alpelisib Rash in Metastatic PIK3CA-mutant Hormone-Receptor Positive Breast Cancer,TERMINATED,,PHASE2,1.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,Limited amount of eligible participants,f,,,,,t,f,,,f,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-16 21:30:42.338384,2024-10-16 21:30:42.338384,OTHER,,,,,,,2024,0.0
NCT04496999,,2020-07-29,,,2022-10-03,2020-07-29,2020-08-04,ACTUAL,,,,,,,2022-10-03,2022-10-06,ACTUAL,2020-07-13,ACTUAL,2020-07-13,2022-10,2022-10-31,2022-09-09,ACTUAL,2022-09-09,2022-09-09,ACTUAL,2022-09-09,,INTERVENTIONAL,HDMM,,HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt.,HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt; a Phase I Study.,TERMINATED,,PHASE1,2.0,ACTUAL,"Insel Gruppe AG, University Hospital Bern",,1.0,,Insufficient recruitment,f,,,,f,f,f,,,,,,,,,YES,,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,OTHER,,,,,,,2022,0.0
NCT05238844,,2022-01-13,,,2022-05-25,2022-02-03,2022-02-14,ACTUAL,,,,,,,2022-05-25,2022-05-31,ACTUAL,2022-04-11,ACTUAL,2022-04-11,2022-05,2022-05-31,2022-05-25,ACTUAL,2022-05-25,2022-05-25,ACTUAL,2022-05-25,,INTERVENTIONAL,,,A Study of Safety and Efficacy of ATI-2173 and Vebicorvir in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection,"A Phase 2a Randomized, Double-blinded, Placebo-controlled, Multi Center, Dose Ranging Study of the Safety and Efficacy of ATI-2173 and Vebicorvir in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection",TERMINATED,,PHASE2,2.0,ACTUAL,"Antios Therapeutics, Inc",,2.0,,Sponsor stopped due to partner collaboration ending,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,INDUSTRY,,,,,,,2022,0.0
NCT03641326,,2018-08-21,2022-02-14,,2022-03-24,2018-08-21,2018-08-22,ACTUAL,2022-03-24,2022-04-19,ACTUAL,,,,2022-03-24,2022-04-19,ACTUAL,2019-02-21,ACTUAL,2019-02-21,2022-03,2022-03-31,2021-04-02,ACTUAL,2021-04-02,2021-04-02,ACTUAL,2021-04-02,,INTERVENTIONAL,,,Sunitinib in Sarcomas of the Central Nervous System,Phase II Clinical Trial of Sunitinib in Sarcomas of the Central Nervous System,TERMINATED,,PHASE2,5.0,ACTUAL,National Institutes of Health Clinical Center (CC),"National Institutes of Health (NIH) clinical center is a quaternary care facility where we rely heavily on self-referrals and outside physician referrals for accrual. Competing trials at NIH and outside institutions have shifted interest from this study and physicians are not referring patients for this study. Consequently, we have had low accrual.",3.0,,Poor accrual,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,NIH,,,,,,,2021,0.0
NCT04762875,,2021-02-12,2024-07-23,2022-08-25,2024-08-26,2021-02-16,2021-02-21,ACTUAL,2024-08-26,2024-08-29,ACTUAL,,2024-08-29,ACTUAL,2024-08-26,2024-08-29,ACTUAL,2021-06-16,ACTUAL,2021-06-16,2024-08,2024-08-31,2022-03-14,ACTUAL,2022-03-14,2021-09-14,ACTUAL,2021-09-14,,INTERVENTIONAL,,,MGTA-145 + Plerixafor in the Mobilization of HSCs for Allogeneic Transplant in Hematologic Malignancies,A Phase II Study Evaluating the Safety and Efficacy of MGTA-145 in Combination With Plerixafor for the Mobilization and Transplantation of HLA-Matched Donor Hematopoietic Stem Cells in Recipients With Hematological Malignancies,TERMINATED,,PHASE2,7.0,ACTUAL,Ensoma,,1.0,,This study was voluntarily terminated due to a business decision not to proceed and not due to any safety issue,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,INDUSTRY,,,,,,,2022,0.0
NCT03668119,,2018-09-11,2023-04-24,,2024-07-31,2018-09-11,2018-09-12,ACTUAL,2023-04-24,2023-05-18,ACTUAL,,,,2024-07-31,2024-08-28,ACTUAL,2018-10-31,ACTUAL,2018-10-31,2024-07,2024-07-31,2023-08-02,ACTUAL,2023-08-02,2022-05-03,ACTUAL,2022-05-03,,INTERVENTIONAL,CheckMate 848,,A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H),"A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)",COMPLETED,,PHASE2,212.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,INDUSTRY,,,,,,,2023,1.0
NCT04454398,,2020-06-30,,,2021-01-06,2020-06-30,2020-07-01,ACTUAL,,,,,,,2021-01-06,2021-01-08,ACTUAL,2020-09,ESTIMATED,2020-09-30,2021-01,2021-01-31,2021-01,ESTIMATED,2021-01-31,2021-01,ESTIMATED,2021-01-31,,INTERVENTIONAL,,,Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19,"A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-1499 (COVI-GUARD™) in Hospitalized Patients With Moderate COVID-19",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,2.0,,Difficulty recruiting,f,,,,t,t,f,,,,,,,,,,,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,INDUSTRY,,,,,,,2021,0.0
NCT03695380,,2018-09-30,,,2023-08-11,2018-10-02,2018-10-04,ACTUAL,,,,,,,2023-08-11,2023-08-14,ACTUAL,2019-01-09,ACTUAL,2019-01-09,2023-08,2023-08-31,2023-07-12,ACTUAL,2023-07-12,2023-07-12,ACTUAL,2023-07-12,,INTERVENTIONAL,,,"A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer","A Phase Ib Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab, To Patients With Advanced Platinum-sensitive Ovarian Cancer",COMPLETED,,PHASE1,77.0,ACTUAL,Hoffmann-La Roche,,4.0,,,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,INDUSTRY,,,,,,,2023,1.0
NCT04871711,,2021-04-29,2023-10-30,,2024-05-25,2021-04-29,2021-05-04,ACTUAL,2024-05-25,2024-09-23,ACTUAL,,,,2024-05-25,2024-09-23,ACTUAL,2021-05-10,ACTUAL,2021-05-10,2024-05,2024-05-31,2022-10-31,ACTUAL,2022-10-31,2022-10-31,ACTUAL,2022-10-31,,INTERVENTIONAL,DELTA 1,,Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema,A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 1),COMPLETED,,PHASE3,487.0,ACTUAL,LEO Pharma,,2.0,,,f,,,,f,f,f,,,,,,Data is available to request after results of the trial are available on leopharmatrials.com,Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.,http://leopharmatrials.com/for-professionals,YES,De-identified IPD can be made available to researchers in a closed environment for a specified period of time.,2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,INDUSTRY,,,,,,,2022,1.0
NCT04370873,,2020-04-29,2023-01-05,,2024-07-31,2020-04-29,2020-05-01,ACTUAL,2023-11-16,2024-04-26,ACTUAL,,,,2024-07-31,2024-08-28,ACTUAL,2020-06-05,ACTUAL,2020-06-05,2024-07,2024-07-31,2022-01-12,ACTUAL,2022-01-12,2022-01-12,ACTUAL,2022-01-12,,INTERVENTIONAL,,One participant in Part 1 also participated in Part 2. That participant is counted only in Part 1 for baseline characteristics.,MK-5475 in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD) (MK-5475-006),"A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose MK-5475 in Participants With Pulmonary Hypertension Associated With COPD",COMPLETED,,PHASE1,22.0,ACTUAL,Merck Sharp & Dohme LLC,,4.0,,,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,INDUSTRY,,,,,,,2022,0.0
NCT03831113,,2019-01-22,2024-07-30,,2024-08-23,2019-02-04,2019-02-05,ACTUAL,2024-08-23,2024-08-29,ACTUAL,,,,2024-08-23,2024-08-29,ACTUAL,2019-04-13,ACTUAL,2019-04-13,2024-08,2024-08-31,2022-12-22,ACTUAL,2022-12-22,2022-12-22,ACTUAL,2022-12-22,,INTERVENTIONAL,,,Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy,Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy,TERMINATED,,PHASE2,13.0,ACTUAL,University of Pittsburgh,This portion of the study was terminated due to poor recruitment and poor compliance of recruited subjects,2.0,,poor recruitment,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,OTHER,,,,,,,2022,0.0
NCT03726515,,2018-10-26,,,2023-06-20,2018-10-30,2018-10-31,ACTUAL,,,,,,,2023-06-20,2023-06-22,ACTUAL,2019-03-11,ACTUAL,2019-03-11,2021-03,2021-03-31,2021-02-27,ACTUAL,2021-02-27,2021-02-27,ACTUAL,2021-02-27,,INTERVENTIONAL,,,CART-EGFRvIII + Pembrolizumab in GBM,"Phase 1 Study of EGFRvIII-Directed CAR T Cells Combined With PD-1 Inhibition in Patients With Newly Diagnosed, MGMT-Unmethylated Glioblastoma",COMPLETED,,PHASE1,7.0,ACTUAL,University of Pennsylvania,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,OTHER,,,,,,,2021,0.0
NCT03162510,,2016-11-15,,,2022-04-05,2017-05-19,2017-05-22,ACTUAL,,,,,,,2022-04-05,2022-04-07,ACTUAL,2018-06-26,ACTUAL,2018-06-26,2021-06,2021-06-30,2022-01-31,ACTUAL,2022-01-31,2021-06-07,ACTUAL,2021-06-07,,INTERVENTIONAL,SOLAR,,"Biweekly SOLAR, as First-line C/T in Pts With Gastric, Pancreatic and Biliary Cancers","An Phase I Dose-Escalation Study of Biweekly Abraxane in Combination With Oxaliplatin and Oral S-1/LV (SOLAR Regimen) as First-line Chemotherapy in Patients With Advanced Gastric, Pancreatic and Biliary Cancers",COMPLETED,,PHASE1,18.0,ACTUAL,"National Health Research Institutes, Taiwan",,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,OTHER,,,,,,,2022,1.0
NCT02680574,,2016-02-09,2022-04-25,2021-06-17,2022-06-07,2016-02-09,2016-02-11,ESTIMATED,2022-06-07,2022-06-27,ACTUAL,2021-06-17,2021-06-22,ACTUAL,2022-06-07,2022-06-27,ACTUAL,2016-02,ACTUAL,2016-02-29,2022-06,2022-06-30,2020-07-31,ACTUAL,2020-07-31,2020-06-18,ACTUAL,2020-06-18,,INTERVENTIONAL,,,Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD),"Phase 3, Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CONVERSION)",COMPLETED,,PHASE3,1725.0,ACTUAL,Akebia Therapeutics,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,INDUSTRY,,,,,,,2020,1.0
NCT04677426,,2020-12-16,,,2022-09-06,2020-12-16,2020-12-21,ACTUAL,,,,,,,2022-09-06,2022-09-10,ACTUAL,2022-05-01,ACTUAL,2022-05-01,2022-09,2022-09-30,2022-08-01,ACTUAL,2022-08-01,2022-08-01,ACTUAL,2022-08-01,,INTERVENTIONAL,,,129Xe Gas Exchange Imaging in IPF and cHP: A Reliability Study,129Xe Gas Exchange Imaging in IPF and cHP: A Reliability Study,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Kansas Medical Center,,1.0,,Sponsor withdrew Funding,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,OTHER,,,,,,,2022,0.0
NCT01757535,,2012-11-21,2020-09-29,2019-10-16,2024-08-12,2012-12-21,2012-12-31,ESTIMATED,2020-11-04,2020-11-06,ACTUAL,2019-10-16,2019-10-24,ACTUAL,2024-08-12,2024-08-28,ACTUAL,2013-04-24,ACTUAL,2013-04-24,2024-08,2024-08-31,2024-06-18,ACTUAL,2024-06-18,2019-07-15,ACTUAL,2019-07-15,,INTERVENTIONAL,QUAZAR AML-001,"The intent to treat (ITT) population includes participants who were randomized, regardless of whether they received treatment or not.",Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission",COMPLETED,,PHASE3,472.0,ACTUAL,Celgene,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,INDUSTRY,,,,,,,2024,1.0
NCT04383691,,2020-04-16,,,2023-01-12,2020-05-08,2020-05-12,ACTUAL,,,,,,,2023-01-12,2023-01-17,ACTUAL,2020-12-11,ACTUAL,2020-12-11,2023-01,2023-01-31,2022-12-23,ACTUAL,2022-12-23,2022-12-23,ACTUAL,2022-12-23,,INTERVENTIONAL,,,A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression,"A Randomized, 6-Week, Multicenter, Double-Blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression",TERMINATED,,PHASE3,124.0,ACTUAL,"Sumitomo Pharma (Suzhou) Co., Ltd.",,2.0,,Company's business decision,f,,,,f,f,f,,,,,,,,,NO,There is no plan to share IPD.,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,INDUSTRY,,,,,,,2022,0.0
NCT03733132,,2018-10-16,2024-04-03,,2024-05-24,2018-11-06,2018-11-07,ACTUAL,2024-05-24,2024-06-18,ACTUAL,,,,2024-05-24,2024-06-18,ACTUAL,2019-03-15,ACTUAL,2019-03-15,2024-05,2024-05-31,2023-04-05,ACTUAL,2023-04-05,2023-04-05,ACTUAL,2023-04-05,,INTERVENTIONAL,,,Metformin Effect on Brain Function in Insulin Resistant Elderly People,Metformin Effect on Brain Function in Insulin Resistant Elderly People,COMPLETED,,PHASE2,40.0,ACTUAL,Mayo Clinic,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER,,,,,,,2023,1.0
NCT06110494,,2023-10-25,2024-02-12,,2024-08-04,2023-10-25,2023-10-31,ACTUAL,2024-08-04,2024-08-28,ACTUAL,,,,2024-08-04,2024-08-28,ACTUAL,2020-07-13,ACTUAL,2020-07-13,2024-08,2024-08-31,2022-03-10,ACTUAL,2022-03-10,2022-03-10,ACTUAL,2022-03-10,,INTERVENTIONAL,,,A New Clinical Use of Ferumoxytol Nanoparticles: An Antibiofilm Treatment,A New Clinical Use of Ferumoxytol Nanoparticles: An Antibiofilm Treatment,COMPLETED,,PHASE4,44.0,ACTUAL,University of Pennsylvania,we emphasize the limitation of our clinical study. Limitations include the small sample size,3.0,,,f,,,,t,t,f,,,t,,,the supporting information will be available with the publication,,,YES,"Only the participants chart numbers were collected during the study. The study protocol, statistical analysis plan and informed consent form will be published as supporting information with the final manuscript",2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,OTHER,,,,,,,2022,1.0
NCT04164732,,2019-11-13,2024-08-05,,2024-08-05,2019-11-13,2019-11-15,ACTUAL,2024-08-05,2024-08-29,ACTUAL,,,,2024-08-05,2024-08-29,ACTUAL,2020-01-08,ACTUAL,2020-01-08,2024-08,2024-08-31,2023-08-22,ACTUAL,2023-08-22,2023-08-22,ACTUAL,2023-08-22,,INTERVENTIONAL,,,Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy,"A Multi-center, Randomized, Placebo-controlled Patient and Investigator-blinded Study to Explore the Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy (nHCM)",COMPLETED,,PHASE2,46.0,ACTUAL,Novartis,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,INDUSTRY,,,,,,,2023,1.0
NCT04428268,,2020-04-26,,,2021-02-16,2020-06-10,2020-06-11,ACTUAL,,,,,,,2021-02-16,2021-02-18,ACTUAL,2020-03-10,ACTUAL,2020-03-10,2021-02,2021-02-28,2021-02-16,ACTUAL,2021-02-16,2020-06-10,ACTUAL,2020-06-10,,INTERVENTIONAL,,,Chloroquine + Losartan Compared to Chloroquine Alone for the Treatment of COVID-19 Pneumonia,"Phase II, Randomized, Double-blind, Controlled Clinical Trial Evaluating the Efficacy and Safety of Chloroquine + Low Dose Losartan Compared to Chloroquine Monotherapy in Subjects With SARS-CoV-2 Pneumonia",WITHDRAWN,,PHASE2,0.0,ACTUAL,Hospital Universitario Dr. Jose E. Gonzalez,,2.0,,evidence showed chloroquine is not effective against COVID-19,f,,,,f,f,f,,,f,,,,,,,,2024-10-16 00:39:57.765123,2024-10-16 00:39:57.765123,OTHER,,,,,,,2021,0.0
NCT04351919,,2020-04-15,,,2020-08-26,2020-04-16,2020-04-17,ACTUAL,,,,,,,2020-08-26,2020-08-28,ACTUAL,2020-05-05,ESTIMATED,2020-05-05,2020-08,2020-08-31,2020-07-15,ESTIMATED,2020-07-15,2020-07-15,ESTIMATED,2020-07-15,,INTERVENTIONAL,COVID+PA,,Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+),"Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+), inTunisia",WITHDRAWN,,PHASE4,0.0,ACTUAL,Abderrahmane Mami Hospital,,1.0,,- Interest in the use of HCQ is controversial.,f,,,,t,f,f,,,,,,,,,,,2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,OTHER,,,,,,,2020,0.0
NCT04297748,,2020-03-04,,,2023-01-13,2020-03-04,2020-03-05,ACTUAL,,,,,,,2023-01-13,2023-01-17,ACTUAL,2020-06-01,ACTUAL,2020-06-01,2023-01,2023-01-31,2022-11-30,ACTUAL,2022-11-30,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,,,Bioimaging Study of 89Zr-M7824 in NSCLC,A Bioimaging Study of 89Zr-M7824 PET Scans in Patients With Advanced or Metastatic NSCLC Receiving M7824 Alone or in Combination With Chemotherapy,TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,Olivia Newton-John Cancer Research Institute,,2.0,,Efficacy finding,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,OTHER,,,,,,,2022,0.0
NCT04114630,,2019-08-21,,,2020-05-28,2019-10-01,2019-10-03,ACTUAL,,,,,,,2020-05-28,2020-06-01,ACTUAL,2019-10-30,ESTIMATED,2019-10-30,2019-09,2019-09-30,2022-01-07,ESTIMATED,2022-01-07,2021-12-06,ESTIMATED,2021-12-06,,INTERVENTIONAL,COMIG,,Study of Quality of Life in Subjects With Chronic or High-frequency Episodic Migraine and Associated Comorbidities Treated With Erenumab,"A 12-month Prospective, Phase IIIb, Multicenter, Open-label Clinical Trial to Assess Health-related Quality of Life (HRQoL) in Patients With Chronic or High-frequency Episodic Migraine Treated With Erenumab Who Present Associated Comorbidities",WITHDRAWN,,PHASE3,0.0,ACTUAL,Novartis,,1.0,,No patients were enrolled and global prioritization of pipeline and research strategy,f,,,,f,t,f,,,t,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,INDUSTRY,,,,,,,2022,0.0
NCT04545008,,2020-09-01,2022-02-04,,2022-02-16,2020-09-09,2020-09-10,ACTUAL,2022-02-16,2022-02-18,ACTUAL,,,,2022-02-16,2022-02-18,ACTUAL,2020-10-20,ACTUAL,2020-10-20,2022-02,2022-02-28,2021-06-02,ACTUAL,2021-06-02,2021-06-02,ACTUAL,2021-06-02,,INTERVENTIONAL,,,Trial of Famotidine & N-Acetyl Cysteine for Outpatients With COVID-19,A Phase I Clinical Trial of the Combination of Famotidine (FAM) and Oral N-Acetyl Cysteine (NAC) Open Label for Outpatient Treatment of Subjects With Newly Diagnosed SARS-CoV-2 Infection,TERMINATED,,PHASE1,2.0,ACTUAL,Prisma Health-Upstate,Decrease in COVID-19 infections in the area followed by other treatment options led to to poor enrollment (n=2) and early termination of the study.,12.0,,Study was stopped due to poor accrual.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,OTHER,,,,,,,2021,0.0
NCT04192019,,2019-12-06,,,2023-08-30,2019-12-06,2019-12-10,ACTUAL,,,,,,,2023-08-30,2023-09-01,ACTUAL,2023-04,ESTIMATED,2023-04-30,2023-08,2023-08-31,2024-06,ESTIMATED,2024-06-30,2024-04,ESTIMATED,2024-04-30,,INTERVENTIONAL,,,Micro Glucagon During Exercise in Type 1 Diabetes,Subcutaneous Dasiglucagon Use During Exercise In People With Type 1 Diabetes: Effects On Plasma Glucose And Exercise Metabolism,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,"Insel Gruppe AG, University Hospital Bern",,3.0,,Prioritization of other projects,f,,,,,f,f,,,f,,,,,,NO,,2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,OTHER,,,,,,,2024,0.0
NCT03726749,,2018-10-30,2022-09-21,,2022-11-15,2018-10-30,2018-10-31,ACTUAL,2022-11-15,2022-12-02,ACTUAL,,,,2022-11-15,2022-12-02,ACTUAL,2018-11-28,ACTUAL,2018-11-28,2022-11,2022-11-30,2021-12-29,ACTUAL,2021-12-29,2021-12-15,ACTUAL,2021-12-15,,INTERVENTIONAL,,,Tocilizumab Plus a Short Prednisone Taper for GCA,Tocilizumab Plus a Short Prednisone Taper for Giant Cell Arteritis (GCA),COMPLETED,,PHASE4,30.0,ACTUAL,Massachusetts General Hospital,,1.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER,,,,,,,2021,1.0
NCT05251337,,2022-02-03,2024-02-06,,2024-04-19,2022-02-11,2022-02-22,ACTUAL,2024-04-19,2024-05-16,ACTUAL,,,,2024-04-19,2024-05-16,ACTUAL,2022-03-07,ACTUAL,2022-03-07,2024-04,2024-04-30,2023-06-22,ACTUAL,2023-06-22,2023-06-22,ACTUAL,2023-06-22,,INTERVENTIONAL,,,Use of Aromatherapy to Reduce Symptom Burden,Use of Aromatherapy to Reduce Symptom Burden in Patients Receiving Stem Cell Transplantation,COMPLETED,,PHASE2,92.0,ACTUAL,Indiana University,,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,OTHER,,,,,,,2023,1.0
NCT04373616,,2020-04-27,,,2021-10-14,2020-05-01,2020-05-04,ACTUAL,,,,,,,2021-10-14,2021-10-22,ACTUAL,2021-10,ESTIMATED,2021-10-31,2021-10,2021-10-31,2024-10,ESTIMATED,2024-10-31,2024-04,ESTIMATED,2024-04-30,,INTERVENTIONAL,,,A Study of ACI-24 in Adults With Down Syndrome,"A Phase 2 Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability and Target Engagement of ACI-24 in Adults With Down Syndrome",WITHDRAWN,,PHASE2,0.0,ACTUAL,AC Immune SA,,2.0,,decision to proceed with an optimized study design and optimized vaccine formulation,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,INDUSTRY,,,,,,,2024,0.0
NCT03727802,,2018-10-24,2022-12-21,,2022-12-21,2018-10-31,2018-11-01,ACTUAL,2022-12-21,2023-10-23,ACTUAL,,,,2022-12-21,2023-10-23,ACTUAL,2018-11-28,ACTUAL,2018-11-28,2022-06,2022-06-30,2022-04-01,ACTUAL,2022-04-01,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,,,"Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis","TRK-250 - A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Inhaled Dose, Safety, Tolerability, and Pharmacokinetic Study of TRK-250 in Subjects With Idiopathic Pulmonary Fibrosis",COMPLETED,,PHASE1,34.0,ACTUAL,"Toray Industries, Inc",,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,INDUSTRY,,,,,,,2022,1.0
NCT03770728,,2018-12-07,2021-11-04,,2021-11-04,2018-12-07,2018-12-10,ACTUAL,2021-11-04,2021-12-02,ACTUAL,,,,2021-11-04,2021-12-02,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2021-11,2021-11-30,2020-12-27,ACTUAL,2020-12-27,2020-11-28,ACTUAL,2020-11-28,,INTERVENTIONAL,AMPLITUDE-S,"Analysis was performed on Intent-to-treat (ITT) population, which included all participants randomized irrespective of rescue therapy use and compliance with the study protocol and procedures, and were analyzed according to the treatment group allocated by randomization.",Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea,"A 30-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea",TERMINATED,,PHASE3,312.0,ACTUAL,Sanofi,"The study was terminated early by the Sponsor on 09 September 2020. Due to early termination of the study, few efficacy evaluations and analyses originally planned in the protocol were no longer considered to be applicable and were not performed. Primary, and secondary efficacy data were descriptively summarized.",4.0,,"Sponsor decision to cancel TRIAL, not related to safety concern",f,,,,t,t,f,,,f,,,,,,NO,No plan to share individual participant data (IPD) by SANOFI: Product rights transferred to Hanmi Pharmaceutical.,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,INDUSTRY,,,,,,,2020,0.0
NCT05669417,,2022-12-08,,,2024-08-26,2022-12-21,2022-12-30,ACTUAL,,,,,,,2024-08-26,2024-08-28,ACTUAL,2022-08-01,ACTUAL,2022-08-01,2024-08,2024-08-31,2023-08-06,ACTUAL,2023-08-06,2023-07-17,ACTUAL,2023-07-17,,INTERVENTIONAL,POMPAE,,Peri-Operative Magnesium Infusion to Prevent Atrial Fibrillation Evaluated.,Randomized Controlled Trial of Magnesium Sulfate Versus Placebo on the Prevention of Atrial Fibrillation Post Cardiac Surgery.,TERMINATED,,PHASE2/PHASE3,265.0,ACTUAL,HagaZiekenhuis,,2.0,,Futility after interim analysis,f,,,,t,f,f,,,f,,,"2023/2024, a study protocol will be prepared as a separate manuscript and submitted for publication in a peer reviewed journal. This will also include the Statistical Analysis Plan.","Upon acceptance of the study protocol in a peer reviewed journal, the materials are available online.",,YES,"If required and request is made, this will be discussed within the study group and shared if no concerns are raised.",2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,OTHER,,,,,,,2023,0.0
NCT04526717,,2020-07-30,,,2021-06-08,2020-08-21,2020-08-26,ACTUAL,,,,,,,2021-06-08,2021-06-11,ACTUAL,2021-12,ESTIMATED,2021-12-31,2021-06,2021-06-30,2022-12,ESTIMATED,2022-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Heat Shock Protein Inhibitor- MPT0B640 for COVID-19 Infection,"Phase 1, Open Label, Single Arm Study to Evaluate the Safety, Tolerability and Efficacy of MPT0B640 in Patients With COVID-19 Infection",WITHDRAWN,,PHASE1,0.0,ACTUAL,J Ints Bio,,1.0,,Study was determined not to initiate.,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,INDUSTRY,,,,,,,2022,0.0
NCT05098249,,2021-10-14,,,2023-05-23,2021-10-27,2021-10-28,ACTUAL,,,,,,,2023-05-23,2023-05-24,ACTUAL,2021-11-11,ACTUAL,2021-11-11,2023-05,2023-05-31,2023-05-23,ACTUAL,2023-05-23,2023-05-09,ACTUAL,2023-05-09,,INTERVENTIONAL,,,Ferric Carboxymaltose With or Without Phosphate Substitution for the Treatment of Iron Deficiency or Iron Deficiency Anemia,Ferric Carboxymaltose With or Without Phosphate Substitution for the Treatment of Iron Deficiency or Iron Deficiency Anemia Before Elective Surgery - the DeFICIT Trial,COMPLETED,,PHASE4,92.0,ACTUAL,University of Zurich,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER,,,,,,,2023,1.0
NCT03866798,,2019-03-06,2024-07-15,,2024-09-09,2019-03-06,2019-03-07,ACTUAL,2024-07-15,2024-08-07,ACTUAL,,,,2024-09-09,2024-09-24,ACTUAL,2020-01-21,ACTUAL,2020-01-21,2024-09,2024-09-30,2024-05-17,ACTUAL,2024-05-17,2023-09-19,ACTUAL,2023-09-19,,INTERVENTIONAL,,,Study to Evaluate the Efficacy and Safety of PANZYGA in Pediatric Patients With Chronic Immune Thrombocytopenia (ITP),Post-Marketing Study to Evaluate the Efficacy and Safety of PANZYGA in Pediatric Patients With Chronic Immune Thrombocytopenia (ITP),TERMINATED,,PHASE4,6.0,ACTUAL,Octapharma,,1.0,,FDA released Octapharma from the pediatric post marketing requirement.,,,,,,t,f,,,,,,,,,NO,,2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,INDUSTRY,,,,,,,2024,0.0
NCT02741570,,2016-04-13,2022-04-06,,2023-08-31,2016-04-14,2016-04-18,ESTIMATED,2022-04-06,2022-05-03,ACTUAL,,,,2023-08-31,2023-09-21,ACTUAL,2016-10-05,ACTUAL,2016-10-05,2023-08,2023-08-31,2022-09-22,ACTUAL,2022-09-22,2021-05-10,ACTUAL,2021-05-10,,INTERVENTIONAL,CheckMate 651,,Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck,"An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination With Ipilimumab Versus Extreme Study Regimen (Cetuximab + Cisplatin/Carboplatin + Fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)",COMPLETED,,PHASE3,947.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,INDUSTRY,,,,,,,2022,1.0
NCT02664051,,2015-11-24,,,2024-07-09,2016-01-21,2016-01-26,ESTIMATED,,,,,,,2024-07-09,2024-07-10,ACTUAL,2013-08,,2013-08-31,2015-11,2015-11-30,2021-06-29,ACTUAL,2021-06-29,2016-12,ACTUAL,2016-12-31,,INTERVENTIONAL,,,Mast Cells in Acid-induced Intestinal Permeability,The Role of Mast Cells on Duodenal Permeability After Duodenal Acid Perfusion in Healthy Volunteers,TERMINATED,,PHASE4,20.0,ACTUAL,Universitaire Ziekenhuizen KU Leuven,,2.0,,Inactive,f,,,,f,,,,,,,,,,,,,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,OTHER,,,,,,,2021,0.0
NCT04506463,,2020-08-06,2024-06-17,2023-03-29,2024-08-02,2020-08-06,2020-08-10,ACTUAL,2024-08-02,2024-08-29,ACTUAL,,2024-08-29,ACTUAL,2024-08-02,2024-08-29,ACTUAL,2020-12-22,ACTUAL,2020-12-22,2024-06,2024-06-30,2022-08-10,ACTUAL,2022-08-10,2022-05-04,ACTUAL,2022-05-04,,INTERVENTIONAL,,,Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis,"A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Single-administration, Multiple-Dose Study to Demonstrate the Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis",COMPLETED,,PHASE2,397.0,ACTUAL,Sun Pharmaceutical Industries Limited,,6.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,INDUSTRY,,,,,,,2022,1.0
NCT03943550,,2019-05-07,2022-07-21,,2023-06-22,2019-05-08,2019-05-09,ACTUAL,2023-06-22,2024-02-15,ACTUAL,,,,2023-06-22,2024-02-15,ACTUAL,2019-05-13,ACTUAL,2019-05-13,2023-06,2023-06-30,2021-07-22,ACTUAL,2021-07-22,2021-07-22,ACTUAL,2021-07-22,,INTERVENTIONAL,,Intent-to-Treat (ITT) population included all randomized participants.,"Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Participants With Ulcerative Colitis (UC)","A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy, and Pharmacodynamics of Subcutaneously Administered RO7049665 in Participants With Active Ulcerative Colitis",TERMINATED,,PHASE1,45.0,ACTUAL,Hoffmann-La Roche,,2.0,,"The decision to terminate study WP40161 was based on that treatment with RO7049665 showed trends in efficacy, however these data were below expectations and would not have supported superiority over standard of care.",f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,INDUSTRY,,,,,,,2021,0.0
NCT03315143,,2017-10-16,2022-09-30,2020-10-23,2022-09-30,2017-10-16,2017-10-19,ACTUAL,2022-09-30,2022-10-28,ACTUAL,2020-10-23,2020-10-28,ACTUAL,2022-09-30,2022-10-28,ACTUAL,2017-12-19,ACTUAL,2017-12-19,2022-09,2022-09-30,2020-07-08,ACTUAL,2020-07-08,2020-07-08,ACTUAL,2020-07-08,,INTERVENTIONAL,SCORED,Intent-to-treat (ITT) population included all randomized participants analyzed according to the treatment group.,Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk,"A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function",TERMINATED,,PHASE3,10584.0,ACTUAL,Lexicon Pharmaceuticals,The study was terminated prematurely due to business decision.,2.0,,study terminated due to business decision,f,,,,t,t,f,,,f,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.",2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,INDUSTRY,,,,,,,2020,0.0
NCT03763929,,2018-12-03,2021-05-24,,2021-05-24,2018-12-03,2018-12-04,ACTUAL,2021-05-24,2021-06-18,ACTUAL,,,,2021-05-24,2021-06-18,ACTUAL,2019-08-22,ACTUAL,2019-08-22,2020-12,2020-12-31,2020-10-19,ACTUAL,2020-10-19,2020-10-19,ACTUAL,2020-10-19,,INTERVENTIONAL,PHAST-TSC,,Efficacy and Safety of Trans Sodium Crocetinate (TSC) for Treatment of Suspected Stroke,"Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of Efficacy and Safety of Trans Sodium Crocetinate (TSC) Administered Onboard Emergency Vehicles for Treatment of Suspected Stroke: PHAST-TSC",TERMINATED,,PHASE2,6.0,ACTUAL,Diffusion Pharmaceuticals Inc,"The trial was early terminated after 6 subjects were enrolled due to logistical issues surrounding the COVID-19 pandemic. Due to this low enrollment number, the statistical plan outlined in the protocol was not utilized. Data listings and tables were instead created, which captured data on the 6 subjects in a descriptive manner. Therefore, no substantive conclusions could be drawn.",2.0,,The study was stopped due to lack of meaningful enrollment due to the COVID-19 pandemic.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,INDUSTRY,,,,,,,2020,0.0
NCT01270074,,2010-12-23,,,2021-09-08,2011-01-04,2011-01-05,ESTIMATED,,,,,,,2021-09-08,2021-09-16,ACTUAL,2012-04,ACTUAL,2012-04-30,2019-11,2019-11-30,2021-03,ACTUAL,2021-03-31,2020-03,ACTUAL,2020-03-31,,INTERVENTIONAL,COMBATCF,,Prevention of Bronchiectasis in Infants With Cystic Fibrosis,A Phase 3 Multi-centre Randomised Placebo-controlled Study of Azithromycin in the Primary Prevention of Radiologically-defined Bronchiectasis in Infants With Cystic Fibrosis.,COMPLETED,,PHASE3,130.0,ACTUAL,The University of Queensland,,2.0,,,f,,,,t,,,,,,,,,,,YES,,2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,OTHER,,,,,,,2021,1.0
NCT03396484,,2018-01-04,,,2020-06-26,2018-01-04,2018-01-11,ACTUAL,,,,,,,2020-06-26,2020-06-30,ACTUAL,2020-09,ESTIMATED,2020-09-30,2020-06,2020-06-30,2022-03,ESTIMATED,2022-03-31,2022-03,ESTIMATED,2022-03-31,,INTERVENTIONAL,TN-23,,Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes,Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes Mellitus,WITHDRAWN,,PHASE2,0.0,ACTUAL,National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),,2.0,,Study not begun due to continued laboratory work on the feasibility of outcome measures.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,NIH,,,,,,,2022,0.0
NCT03841773,,2019-02-12,,,2021-02-08,2019-02-13,2019-02-15,ACTUAL,,,,,,,2021-02-08,2021-02-11,ACTUAL,2019-03-07,ACTUAL,2019-03-07,2021-02,2021-02-28,2020-04-24,ACTUAL,2020-04-24,2020-04-24,ACTUAL,2020-04-24,,INTERVENTIONAL,RECOVERY,,A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD,"A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)",TERMINATED,,PHASE3,192.0,ACTUAL,"Tonix Pharmaceuticals, Inc.",,2.0,,Interim Analysis results,f,,,,f,t,f,,,,,,,,,,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,INDUSTRY,,,,,,,2020,0.0
NCT03866239,,2019-03-06,,,2024-08-07,2019-03-06,2019-03-07,ACTUAL,,,,,,,2024-08-07,2024-08-09,ACTUAL,2019-05-07,ACTUAL,2019-05-07,2024-08,2024-08-31,2024-03-13,ACTUAL,2024-03-13,2024-03-13,ACTUAL,2024-03-13,,INTERVENTIONAL,,,"A Phase Ib Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Participants With Previously Treated Metastatic Colorectal Adenocarcinoma","A Phase Ib, Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Patients With Previously Treated Metastatic, Microsatellite-Stable Colorectal Adenocarcinoma With High CEACAM5 Expression",TERMINATED,,PHASE1,47.0,ACTUAL,Hoffmann-La Roche,,1.0,,The Sponsor terminated the study because development of cibisatamab has been discontinued.,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,INDUSTRY,,,,,,,2024,0.0
NCT03806933,,2019-01-15,2023-09-07,2021-09-07,2023-11-10,2019-01-15,2019-01-16,ACTUAL,2023-09-07,2023-10-04,ACTUAL,2021-09-07,2021-09-10,ACTUAL,2023-11-10,2023-11-15,ACTUAL,2019-01-23,ACTUAL,2019-01-23,2023-11,2023-11-30,2020-10-08,ACTUAL,2020-10-08,2020-09-10,ACTUAL,2020-09-10,,INTERVENTIONAL,,The full analysis set (FAS) was subset of participants exposed to study medication for whom any efficacy variable was available.,Study to Investigate the Safety and Duration of Effect of Different Botulinum Toxin A (NT 201) Dose Groups Following the Treatment of Glabellar Frown Lines,"A Prospective, Randomized, Double-blind, Multicenter Study to Investigate the Safety and Duration of Effect of Different NT 201 Dose Groups Following the Treatment of Glabellar Frown Lines",COMPLETED,,PHASE2,241.0,ACTUAL,"Merz North America, Inc.",,5.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,INDUSTRY,,,,,,,2020,1.0
NCT04510844,,2020-06-30,,,2022-07-27,2020-08-11,2020-08-12,ACTUAL,,,,,,,2022-07-27,2022-07-28,ACTUAL,2021-03-01,ACTUAL,2021-03-01,2022-07,2022-07-31,2021-10-01,ACTUAL,2021-10-01,2021-10-01,ACTUAL,2021-10-01,,INTERVENTIONAL,EVO-CKD,,Evolocumab In Advanced Chronic Kidney Disease Trial,"A Phase IV, Double-Blind, Placebo-Controlled, Multi-Center Trial To Study The Effects Of Evolocumab In Stage IV-V Chronic Kidney Disease: The Cardiovascular and Lipid-Lowering Effects Of Evolocumab In Advanced Chronic Kidney Disease Trial",WITHDRAWN,,PHASE4,0.0,ACTUAL,NYU Langone Health,,2.0,,loss of funding,f,,,,t,t,f,,,t,,,Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.,"The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to David.charytan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.",,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).",2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER,,,,,,,2021,0.0
NCT01601093,,2012-04-27,,,2019-07-02,2012-05-16,2012-05-17,ESTIMATED,,,,,,,2019-07-02,2019-07-05,ACTUAL,2011-11,,2011-11-30,2019-07,2019-07-31,2022-12-15,ESTIMATED,2022-12-15,2022-08-15,ESTIMATED,2022-08-15,,INTERVENTIONAL,CAZ-SBT,,Study on Ceftazidime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection,Phase Ⅱ Study on Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection,SUSPENDED,,PHASE2,288.0,ESTIMATED,"Xiangbei Welman Pharmaceutical Co., Ltd",,3.0,,other project got priority,f,,,,t,,,,,,,,,,,,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,INDUSTRY,,,,,,,2022,0.0
NCT00033293,,2002-04-09,2016-01-28,,2023-03-22,2003-01-26,2003-01-27,ESTIMATED,2016-08-09,2016-10-03,ESTIMATED,,,,2023-03-22,2023-04-18,ACTUAL,2004-03-15,ACTUAL,2004-03-15,2023-01,2023-01-31,2022-12-31,ACTUAL,2022-12-31,2013-12-10,ACTUAL,2013-12-10,,INTERVENTIONAL,,,Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma,A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone,COMPLETED,,PHASE3,53.0,ACTUAL,Children's Oncology Group,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,NETWORK,,,,,,,2022,1.0
NCT04308395,,2020-03-11,2024-07-21,,2024-08-28,2020-03-11,2020-03-16,ACTUAL,2024-08-28,2024-09-24,ACTUAL,,,,2024-08-28,2024-09-24,ACTUAL,2020-06-03,ACTUAL,2020-06-03,2024-07,2024-07-31,2021-07-14,ACTUAL,2021-07-14,2021-07-14,ACTUAL,2021-07-14,,INTERVENTIONAL,,,"Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)","A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)",TERMINATED,,PHASE3,108.0,ACTUAL,"Sol-Gel Technologies, Ltd.",,1.0,,"Study was terminated early due to low blinded event rate and this study termination is not related to safety of the drug Patidegib Topical Gel, 2%.",f,,,,f,t,f,,,,,,,,,,,2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,INDUSTRY,,,,,,,2021,0.0
NCT01045382,,2010-01-08,,,2021-08-31,2010-01-08,2010-01-11,ESTIMATED,,,,,,,2021-08-31,2021-09-08,ACTUAL,2010-07,ACTUAL,2010-07-31,2021-08,2021-08-31,2021-08,ACTUAL,2021-08-31,2021-08,ACTUAL,2021-08-31,,INTERVENTIONAL,,,MSC and HSC Coinfusion in Mismatched Minitransplants,Co-transplantation of Mesenchymal Stem Cells and HLA-mismatched Allogeneic Hematopoietic Cells After Nonmyeloablative Conditioning: a Phase II Randomized Double-blind Study,TERMINATED,,PHASE2,39.0,ACTUAL,University of Liege,,2.0,,recruitment too slow,f,,,,f,,,,,,,,,,,,,2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,OTHER,,,,,,,2021,0.0
NCT04493502,,2020-07-29,2023-03-14,,2023-04-26,2020-07-29,2020-07-30,ACTUAL,2023-04-26,2023-04-28,ACTUAL,,,,2023-04-26,2023-04-28,ACTUAL,2020-08-26,ACTUAL,2020-08-26,2023-04-01,2023-04-01,2022-10-13,ACTUAL,2022-10-13,2022-03-15,ACTUAL,2022-03-15,,INTERVENTIONAL,,All randomized participants who received at least one dose of study drug.,A Study of LY3041658 in Adults With Hidradenitis Suppurativa,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3041658 in Adults With Moderate-to-Severe Hidradenitis Suppurativa",COMPLETED,,PHASE2,72.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,INDUSTRY,,,,,,,2022,1.0
NCT04080752,,2019-09-04,2022-09-02,,2023-06-30,2019-09-04,2019-09-06,ACTUAL,2022-09-02,2022-09-29,ACTUAL,,,,2023-06-30,2023-07-03,ACTUAL,2019-09-17,ACTUAL,2019-09-17,2023-06,2023-06-30,2021-09-02,ACTUAL,2021-09-02,2021-09-02,ACTUAL,2021-09-02,,INTERVENTIONAL,,The safety analysis set included all randomized participants who received at least 1 dose of study agent.,A Study of JNJ-61393215 in the Treatment of Depression,"Double-Blind, Placebo-Controlled, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-61393215 as Adjunctive Treatment in Adults With Major Depressive Disorder With Anxious Distress With Suboptimal Response to Standard Antidepressants",COMPLETED,,PHASE2,222.0,ACTUAL,"Janssen Research & Development, LLC","The study was limited to a single dose level. During the study, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic emerged. Public health measures required progressive restriction of movement of participants, site staff, and sponsor staff. The recruitment and enrollment were halted on 17 March 2020. All ongoing participants were permitted to continue the study if they were able to attend the on-site scheduled visits.",2.0,,,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,INDUSTRY,,,,,,,2021,1.0
NCT03054038,,2016-10-25,,,2022-04-06,2017-02-10,2017-02-15,ACTUAL,,,,,,,2022-04-06,2022-04-14,ACTUAL,2017-07-20,ACTUAL,2017-07-20,2022-04,2022-04-30,2022-03-23,ACTUAL,2022-03-23,2022-03-23,ACTUAL,2022-03-23,,INTERVENTIONAL,,,Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer,Phase I Trial of Combination Afatinib and Necitumumab in EGFR Mutation Positive NSCLC With Acquired Resistance to First or Third Generation EGFR TKIs,TERMINATED,,PHASE1,22.0,ACTUAL,Vanderbilt-Ingram Cancer Center,,1.0,,Low accrual,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,OTHER,,,,,,,2022,0.0
NCT03193359,,2017-06-19,,,2017-07-12,2017-06-19,2017-06-20,ACTUAL,,,,,,,2017-07-12,2017-07-14,ACTUAL,2018-01-15,ESTIMATED,2018-01-15,2017-07,2017-07-31,2021-09-09,ESTIMATED,2021-09-09,2021-09-09,ESTIMATED,2021-09-09,,INTERVENTIONAL,,,Open Label Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine,"A Multicenter, Open-label, Safety, Tolerability and Efficacy Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine",WITHDRAWN,,PHASE3,0.0,ACTUAL,Allergan,,1.0,,Corporate Decision,f,,,,f,f,f,,,,,,,,,,,2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,INDUSTRY,,,,,,,2021,0.0
NCT04770064,,2021-02-16,,,2022-07-26,2021-02-22,2021-02-25,ACTUAL,,,,,,,2022-07-26,2022-07-29,ACTUAL,2023-06,ESTIMATED,2023-06-30,2022-07,2022-07-31,2024-05-31,ESTIMATED,2024-05-31,2024-05-31,ESTIMATED,2024-05-31,,INTERVENTIONAL,ROPE,,Targeting Senescence to Reduce Osteoarthritis Pain and cartilagE Breakdown (ROPE),Targeting Senescence to Reduce Osteoarthritis Pain and cartilagE Breakdown (ROPE),WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Kentucky,,3.0,,Funding was not awarded,f,,,,t,t,f,,,,,,,,,NO,Individual participant data (IDP) will not be made available to other researchers.,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,OTHER,,,,,,,2024,0.0
NCT04626089,,2020-10-23,,,2021-04-05,2020-11-10,2020-11-12,ACTUAL,,,,,,,2021-04-05,2021-04-08,ACTUAL,2021-02,ESTIMATED,2021-02-28,2020-11,2020-11-30,2021-02,ESTIMATED,2021-02-28,2021-02,ESTIMATED,2021-02-28,,INTERVENTIONAL,DMMETCOV19,,"Metformin Glycinate in Patients With MS or DM2 , Hospitalized With COVID-19 and SARS Secondary to SARS-CoV-2","Adaptive Study for Efficacy and Safety of Metformin Glycinate for the Treatment of Patients With MS and DM2, Hospitalized With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. Randomized, Double-Blind, Phase IIIb.",WITHDRAWN,,PHASE2,0.0,ACTUAL,Laboratorios Silanes S.A. de C.V.,,2.0,,Administrative decision of the company,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,INDUSTRY,,,,,,,2021,0.0
NCT04028050,,2019-07-19,,,2024-07-15,2019-07-19,2019-07-22,ACTUAL,,,,,,,2024-07-15,2024-07-16,ACTUAL,2019-08-12,ACTUAL,2019-08-12,2024-07,2024-07-31,2023-07-13,ACTUAL,2023-07-13,2023-07-13,ACTUAL,2023-07-13,,INTERVENTIONAL,MAURIS,,A Study of Atezolizumab in Combination With Carboplatin Plus Etoposide to Investigate Safety and Efficacy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer,"A Phase IIIB, Single Arm, Multicenter Study of Atezolizumab (Tecentriq) in Combination With Carboplatin Plus Etoposide to Investigate Safety and Efficacy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer - MAURIS",COMPLETED,,PHASE3,155.0,ACTUAL,Hoffmann-La Roche,,1.0,,,f,,,,f,f,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,INDUSTRY,,,,,,,2023,1.0
NCT03678506,,2018-09-08,,,2023-02-22,2018-09-18,2018-09-19,ACTUAL,,,,,,,2023-02-22,2023-02-24,ACTUAL,2018-08-16,ACTUAL,2018-08-16,2023-02,2023-02-28,2023-01-31,ACTUAL,2023-01-31,2021-09-01,ACTUAL,2021-09-01,,INTERVENTIONAL,APIDULCIS,,Apixaban for Extended Anticoagulation (APIDULCIS),APIDULCIS: Extended Anticoagulation With Low-dose Apixaban After a Standard Course Anticoagulation in Patients With a First Venous Thromboembolism Who Have Positive D-dimer,TERMINATED,,PHASE4,800.0,ACTUAL,Arianna Anticoagulazione Foundation,,2.0,,"The study was interrupted after a planned interim analysis for the high rate of primary outcomes (7.3%; 95% confidence interval \[CI\], 4.5-11.2)",f,,,,t,f,f,,,,,,The data will be available after the publication of global results of the study or after 18 months from the enrollment of the last patients,Data access requests will be reviewed by the Scientific board of the study.,,YES,All collected data will be shared,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER,,,,,,,2023,0.0
NCT02681302,,2016-01-29,,,2024-06-14,2016-02-11,2016-02-12,ESTIMATED,,,,,,,2024-06-14,2024-06-17,ACTUAL,2016-06-07,ACTUAL,2016-06-07,2024-06,2024-06-30,2024-05-10,ACTUAL,2024-05-10,2024-05-10,ACTUAL,2024-05-10,,INTERVENTIONAL,CPIT001,,Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant Recurrence,Phase Ib-IIA Study of Combined Check Point Inhibition After Autologous Hematopoietic Stem Cell Transplantation in Patients at High Risk for Post-transplant Recurrence,TERMINATED,,PHASE1/PHASE2,35.0,ACTUAL,Hackensack Meridian Health,,1.0,,Lack of Accrual,f,,,,f,,,,,,,,,,,,,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,OTHER,,,,,,,2024,0.0
NCT03775200,,2018-12-11,2023-02-07,,2023-04-21,2018-12-11,2018-12-13,ACTUAL,2023-04-21,2023-04-24,ACTUAL,,,,2023-04-21,2023-04-24,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2023-04,2023-04-30,2021-09-27,ACTUAL,2021-09-27,2021-07-30,ACTUAL,2021-07-30,,INTERVENTIONAL,P-TRD,The Safety Analysis Set included all randomised participants who received study drug.,The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression,The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression,COMPLETED,,PHASE2,233.0,ACTUAL,COMPASS Pathways,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,INDUSTRY,,,,,,,2021,1.0
NCT04963413,,2021-07-12,,,2024-01-10,2021-07-12,2021-07-15,ACTUAL,,,,,,,2024-01-10,2024-01-12,ACTUAL,2022-01-13,ACTUAL,2022-01-13,2024-01,2024-01-31,2023-09-28,ACTUAL,2023-09-28,2023-09-28,ACTUAL,2023-09-28,,INTERVENTIONAL,,,RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.,RENEW: Pilot Study of Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.,TERMINATED,,PHASE1,6.0,ACTUAL,University of Florida,,1.0,,Terminated by mutual agreement by sponsor and institution.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,OTHER,,,,,,,2023,0.0
NCT03938545,,2019-05-01,2022-08-02,,2022-08-26,2019-05-02,2019-05-06,ACTUAL,2022-08-26,2022-09-22,ACTUAL,,,,2022-08-26,2022-09-22,ACTUAL,2019-07-23,ACTUAL,2019-07-23,2022-08,2022-08-31,2021-04-15,ACTUAL,2021-04-15,2021-02-02,ACTUAL,2021-02-02,,INTERVENTIONAL,,,"ASCEND GO-2: Study of RVT-1401 for the Treatment of Participants With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )","ASCEND GO-2: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study of RVT-1401 for the Treatment of Patients With Active, Moderate to Severe Graves' Ophthalmopathy",TERMINATED,,PHASE2,65.0,ACTUAL,Immunovant Sciences GmbH,The study was terminated early due to a safety finding (hypercholesterolemia).,4.0,,Sponsor decision based on premature unblinding of treatment allocations necessitated by program-wide review,f,,,,f,t,f,,,,,,,,,,,2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,INDUSTRY,,,,,,,2021,0.0
NCT03656510,,2018-08-15,2023-04-11,,2023-09-19,2018-08-31,2018-09-04,ACTUAL,2023-09-19,2023-09-21,ACTUAL,,,,2023-09-19,2023-09-21,ACTUAL,2018-11-29,ACTUAL,2018-11-29,2023-09,2023-09-30,2022-04-18,ACTUAL,2022-04-18,2022-04-18,ACTUAL,2022-04-18,,INTERVENTIONAL,,,Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection,"A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses of JNJ-53718678 in Children >=28 Days and <=3 Years of Age With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection",TERMINATED,,PHASE2,246.0,ACTUAL,"Janssen Research & Development, LLC",,3.0,,Janssen made the strategic decision to discontinue the CROCuS study. This decision is not based on any safety concerns.,t,,,,t,t,f,,,,,,,,,,,2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,INDUSTRY,,NCT04221412,NO_LONGER_AVAILABLE,,,,2022,0.0
NCT04050540,,2019-08-06,2023-12-16,,2024-07-03,2019-08-06,2019-08-08,ACTUAL,2024-07-03,2024-07-10,ACTUAL,,,,2024-07-03,2024-07-10,ACTUAL,2020-02-05,ACTUAL,2020-02-05,2024-07,2024-07-31,2022-10-30,ACTUAL,2022-10-30,2022-10-30,ACTUAL,2022-10-30,,INTERVENTIONAL,dPEP-KE,,Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP,PrEP and dPEP: Doxycycline Post-exposure Prophylaxis for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV Pre-exposure Prophylaxis,COMPLETED,,PHASE4,449.0,ACTUAL,University of Washington,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER,,,,,,,2022,0.0
NCT03645395,,2018-07-19,2022-06-01,,2022-07-18,2018-08-22,2018-08-24,ACTUAL,2022-07-18,2022-08-16,ACTUAL,,,,2022-07-18,2022-08-16,ACTUAL,2019-04-08,ACTUAL,2019-04-08,2022-07,2022-07-31,2021-03-10,ACTUAL,2021-03-10,2021-03-10,ACTUAL,2021-03-10,,INTERVENTIONAL,,Part 2 was not initiated due to Sponsor's decision to terminate the trial.,"Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Lenalidomide for the Treatment of Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (MT-3724_NHL_003)","A Phase 2a Open-label Study to Investigate Safety and Tolerability (Including the Maximum Tolerated Dose), Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of MT-3724 in Combination With Lenalidomide in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma",TERMINATED,,PHASE2,9.0,ACTUAL,"Molecular Templates, Inc.",,5.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:37:12.763616,2024-10-16 21:37:12.763616,INDUSTRY,,,,,,,2021,0.0
NCT03713242,,2018-10-18,,,2020-07-01,2018-10-18,2018-10-19,ACTUAL,,,,,,,2020-07-01,2020-07-02,ACTUAL,2018-02-26,ACTUAL,2018-02-26,2020-07,2020-07-31,2020-02-27,ACTUAL,2020-02-27,2020-02-27,ACTUAL,2020-02-27,,INTERVENTIONAL,,,"A Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment","A Single-center, Open-label, Single-dose, Phase 1 Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment",COMPLETED,,PHASE1,32.0,ACTUAL,Idorsia Pharmaceuticals Ltd.,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,INDUSTRY,,,,,,,2020,1.0
NCT05035368,,2021-08-30,,,2023-12-21,2021-08-30,2021-09-05,ACTUAL,,,,,,,2023-12-21,2023-12-22,ACTUAL,2021-09-30,ACTUAL,2021-09-30,2022-01,2022-01-31,2023-06,ESTIMATED,2023-06-30,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,Ladarixin as Adjunctive Therapy to Improve Insulin Sensitivity and Glucometabolic Outcomes in Type 1 Diabetes,Ladarixin 400 mg Twice a Day as Adjunctive Therapy to Improve Insulin Sensitivity and Glucometabolic Outcomes in Overweight Insulin-resistant Type 1 Diabetic Patients,WITHDRAWN,,PHASE2,0.0,ACTUAL,Dompé Farmaceutici S.p.A,,2.0,,"Dompé decided to withdraw LDX0121 following an internal re-planning and an extensive review of the study design.~At the time of withdrawal, no site had been activated and the drug had not been sent to investigators. No patients had been enrolled.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,INDUSTRY,,,,,,,2023,0.0
NCT03988634,,2019-06-13,2023-11-22,,2024-07-25,2019-06-13,2019-06-17,ACTUAL,2024-07-25,2024-07-29,ACTUAL,,,,2024-07-25,2024-07-29,ACTUAL,2019-06-29,ACTUAL,2019-06-29,2024-07,2024-07-31,2022-12-14,ACTUAL,2022-12-14,2022-12-14,ACTUAL,2022-12-14,,INTERVENTIONAL,PARAGLIDE-HF,"Demographic and baseline characteristics are based on the full analysis set (FAS), as primary and secondary analysis are based on the FAS.~The FAS consisted of all patients to whom study treatment was assigned by randomization and at least 1 dose of study treatment received.","Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)","A Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled Study to Evaluate the Effect of Sacubitril/Valsartan (LCZ696) Versus Valsartan on Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)",COMPLETED,,PHASE3,467.0,ACTUAL,Novartis,"No efficacy analyses include OPEN LABEL' data. After Protocol Amendment 01, the open-label option was removed from the study, only the 233 patients randomized in the Double-blind Phase Sacubitril+ Valsartan (LCZ696) and the 233 patients randomized in the Double-blind Phase Valsartan arms were included in the efficacy analysis.",2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of the patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,INDUSTRY,,,,,,,2022,1.0
NCT02907307,,2015-09-23,,,2019-03-06,2016-09-14,2016-09-20,ESTIMATED,,,,,,,2019-03-06,2019-03-08,ACTUAL,2018-12,ESTIMATED,2018-12-31,2017-12,2017-12-31,2020-07,ESTIMATED,2020-07-31,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,"Efficacy, Safety LactiSal 1% Gel, LactSal 50 mg, Clotrimazole 100 mg Tablet in Treatment Vulvovaginal Candidiasis",Comparative Study of the Efficacy and Safety of LactiSal 1% Vaginal Gel and LactSal 50 mg Vaginal Tablet Versus Clotrimazole 100 mg Vaginal Tablet in the Treatment of Vulvovaginal Candidiasis (VVC),WITHDRAWN,,PHASE3,0.0,ACTUAL,Medinova AG,,3.0,,Development project stopped,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,INDUSTRY,,,,,,,2020,0.0
NCT03770494,,2018-12-07,,,2021-11-03,2018-12-07,2018-12-10,ACTUAL,,,,,,,2021-11-03,2021-11-08,ACTUAL,2019-01-31,ACTUAL,2019-01-31,2021-11,2021-11-30,2021-02-04,ACTUAL,2021-02-04,2021-02-04,ACTUAL,2021-02-04,,INTERVENTIONAL,,,A Study of LY3405105 in Participants With Advanced Cancer,A Phase 1a/1b Study of LY3405105 Administered to Patients With Advanced Solid Tumors,TERMINATED,,PHASE1,54.0,ACTUAL,Eli Lilly and Company,,1.0,,The study was terminated for lack of sufficient efficacy.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,INDUSTRY,,,,,,,2021,0.0
NCT02980731,,2016-11-30,2022-12-21,,2023-01-23,2016-11-30,2016-12-02,ESTIMATED,2023-01-23,2023-02-22,ACTUAL,,,,2023-01-23,2023-02-22,ACTUAL,2016-12-13,ACTUAL,2016-12-13,2023-01,2023-01-31,2021-12-29,ACTUAL,2021-12-29,2021-12-29,ACTUAL,2021-12-29,,INTERVENTIONAL,VENICE II,All enrolled participants who received at least one dose of venetoclax,A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).,"Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Impact of Venetoclax on the Quality of Life of Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL) (VENICE II)",COMPLETED,,PHASE3,210.0,ACTUAL,AbbVie,,1.0,,,f,,,,t,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,INDUSTRY,,,,,,,2021,1.0
NCT01958021,,2013-10-04,2017-04-04,,2023-04-25,2013-10-07,2013-10-08,ESTIMATED,2017-04-04,2017-05-12,ACTUAL,,,,2023-04-25,2023-04-26,ACTUAL,2013-12-17,ACTUAL,2013-12-17,2023-04,2023-04-30,2023-03-16,ACTUAL,2023-03-16,2016-01-29,ACTUAL,2016-01-29,,INTERVENTIONAL,MONALEESA-2,The Full Analysis Set (FAS-population) consisted of all randomized patients.,Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2),"A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease",COMPLETED,,PHASE3,668.0,ACTUAL,Novartis,Four patients who were randomized to the placebo plus letrozole arm did not receive study treatment and so are not part of the Safety Set.,2.0,,,f,,,,t,t,f,,,,,,,,http://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.",2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,INDUSTRY,,,,,,,2023,1.0
NCT00195091,,2005-09-14,2024-02-29,,2024-03-28,2005-09-14,2005-09-19,ESTIMATED,2024-03-28,2024-04-23,ACTUAL,,,,2024-03-28,2024-04-23,ACTUAL,2003-12,,2003-12-31,2024-02,2024-02-29,2023-03-02,ACTUAL,2023-03-02,2023-03-02,ACTUAL,2023-03-02,,INTERVENTIONAL,,,Phase II Study of Tetrathiomolybdate (TM) in Patients With Breast Cancer,A Phase II Study of Tetrathiomolybdate (TM) in Patients With Breast Cancer at Moderate to High Risk of Recurrence,TERMINATED,,PHASE2,16.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,PI left MSKCC,f,,,,,t,f,,,,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,OTHER,,,,,,,2023,0.0
NCT03836716,,2019-02-07,2023-05-15,,2023-08-22,2019-02-08,2019-02-11,ACTUAL,2023-08-22,2023-08-24,ACTUAL,,,,2023-08-22,2023-08-24,ACTUAL,2019-09-19,ACTUAL,2019-09-19,2023-08,2023-08-31,2021-07-02,ACTUAL,2021-07-02,2021-07-02,ACTUAL,2021-07-02,,INTERVENTIONAL,,,Arimoclomol in Amyotropic Lateral Sclerosis - Open Label Extension Trial,"Open Label, Non-randomized Extension Trial to Assess Long Term Safety and Efficacy of Arimoclomol in Subjects With Amyotropic Lateral Sclerosis Who Have Completed the ORARIALS-01 Trial",TERMINATED,,PHASE3,120.0,ACTUAL,ZevraDenmark,Early termination led to data for a limited number of patients. No conclusions can be drawn from the laboratory results due to data for only a few patients.,1.0,,"As a consequence of the results of ORARIALS-01 which did not meet any of its efficacy endpoints. The planned duration was 152 weeks. After termination, the actual mean duration of treatment was approx. 28 weeks (range approx. 2 to 71 weeks).",f,,,,f,t,f,,,,,,,,,,,2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,INDUSTRY,,,,,,,2021,0.0
NCT04322123,,2020-03-24,,,2022-04-03,2020-03-24,2020-03-26,ACTUAL,,,,,,,2022-04-03,2022-04-05,ACTUAL,2020-04-01,ACTUAL,2020-04-01,2022-04,2022-04-30,2020-06-02,ACTUAL,2020-06-02,2020-06-02,ACTUAL,2020-06-02,,INTERVENTIONAL,Coalition-I,,Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-Cov-2 Virus (COVID-19),"An Open-label, Randomized Controlled Trial of Hydroxychloroquine and Azithromycin for COVID-19 Infection on Hospitalized, Noncritical Patients",COMPLETED,,PHASE3,667.0,ACTUAL,Hospital do Coracao,,3.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,OTHER,,,,,,,2020,0.0
NCT05788328,,2023-03-15,,,2023-10-05,2023-03-15,2023-03-28,ACTUAL,,,,,,,2023-10-05,2023-10-10,ACTUAL,2023-03-27,ACTUAL,2023-03-27,2023-10,2023-10-31,2023-09-11,ACTUAL,2023-09-11,2023-09-11,ACTUAL,2023-09-11,,INTERVENTIONAL,,,A Drug-Drug Interaction Study to Estimate the Effect of PF-07081532 on the Pharmacokinetics of Dabigatran and Rosuvastatin in Overweight or Obese Adult Participants,"A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO ESTIMATE THE EFFECT OF PF-07081532 ADMINISTRATION ON THE SINGLE-DOSE PHARMACOKINETICS OF DABIGATRAN AND ROSUVASTATIN IN OVERWEIGHT OR OBESE ADULT PARTICIPANTS",TERMINATED,,PHASE1,16.0,ACTUAL,Pfizer,,8.0,,The decision to terminate clinical development of lotiglipron is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,INDUSTRY,,,,,,,2023,0.0
NCT04209725,,2019-12-20,2022-04-18,,2023-12-01,2019-12-20,2019-12-24,ACTUAL,2022-05-10,2022-06-03,ACTUAL,,,,2023-12-01,2023-12-05,ACTUAL,2020-06-03,ACTUAL,2020-06-03,2022-05,2022-05-31,2021-04-20,ACTUAL,2021-04-20,2021-04-20,ACTUAL,2021-04-20,,INTERVENTIONAL,,Only 1 patient was enrolled and treated before study was terminated due to slow accrual,A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia,A Phase II Study Assessing CPX-351 (Vyxeos™) With Quizartinib for the Treatment of Relapsed or Refractory FLT3-ITD Mutation-Positive AML,TERMINATED,,PHASE2,1.0,ACTUAL,"SCRI Development Innovations, LLC",,1.0,,Closed due to slow enrollment,f,,,,f,t,f,,,,,,,,,,,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,OTHER,,,,,,,2021,0.0
NCT04124926,,2019-10-10,2022-07-06,,2022-07-06,2019-10-10,2019-10-14,ACTUAL,2022-07-06,2022-07-29,ACTUAL,,,,2022-07-06,2022-07-29,ACTUAL,2019-10-28,ACTUAL,2019-10-28,2022-07,2022-07-31,2021-08-24,ACTUAL,2021-08-24,2021-07-29,ACTUAL,2021-07-29,,INTERVENTIONAL,,The Randomized Set included all participants randomly assigned to receive study drug regardless of whether or not they received a dose of study drug.,Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis,"A Phase 3, Randomized, Double-Blind, Two Phase, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 20 mg Compared to Lansoprazole 30 mg for Healing in Patients With Erosive Esophagitis and to Evaluate the Efficacy and Safety of Vonoprazan (10 mg and 20 mg) Compared to Lansoprazole 15 mg for the Maintenance of Healing in Patients With Healed Erosive Esophagitis",COMPLETED,,PHASE3,1027.0,ACTUAL,"Phathom Pharmaceuticals, Inc.",,5.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,"Data from this study will be published; however, it is undecided if patient level data will be made available at this time.",2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,INDUSTRY,,,,,,,2021,1.0
NCT02929329,,2016-09-30,2021-05-24,,2021-11-02,2016-10-07,2016-10-11,ESTIMATED,2021-07-16,2021-07-20,ACTUAL,,,,2021-11-02,2021-11-05,ACTUAL,2017-01-06,ACTUAL,2017-01-06,2021-11,2021-11-30,2020-09-14,ACTUAL,2020-09-14,2020-09-14,ACTUAL,2020-09-14,,INTERVENTIONAL,GALACTIC-HF,The full analysis set included all the randomized participants except for 24 patients from a single site who were excluded on the basis of Good Clinical Practice violations.,Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction,"A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)",COMPLETED,,PHASE3,8256.0,ACTUAL,Cytokinetics,,2.0,,,f,,,,t,,,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,INDUSTRY,,,,,,,2020,1.0
NCT05056779,,2021-09-15,,,2023-09-18,2021-09-15,2021-09-27,ACTUAL,,,,,,,2023-09-18,2023-09-21,ACTUAL,2023-01,ESTIMATED,2023-01-31,2021-09,2021-09-30,2023-07,ESTIMATED,2023-07-31,2023-07,ESTIMATED,2023-07-31,,INTERVENTIONAL,,,Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporine A is Not Medically Advisable,"A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporine A is Not Medically Advisable",WITHDRAWN,,PHASE3,0.0,ACTUAL,Galderma R&D,,2.0,,The study data will not be utilized in the IND and is only being conducted in EU.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,INDUSTRY,,,,,,,2023,0.0
NCT00424099,,2007-01-16,2022-10-24,,2023-05-31,2007-01-16,2007-01-18,ESTIMATED,2023-05-31,2023-06-01,ACTUAL,,,,2023-05-31,2023-06-01,ACTUAL,2007-01-09,ACTUAL,2007-01-09,2023-05,2023-05-31,2021-11-22,ACTUAL,2021-11-22,2021-11-22,ACTUAL,2021-11-22,,INTERVENTIONAL,,Analyses included all randomized participants,Methylphenidate and a Nursing Telephone Intervention for Fatigue,A Randomized Controlled Trial of Methylphenidate and a Nursing Telephone Intervention (NTI) for Fatigue in Advanced Cancer Patients,COMPLETED,,PHASE2/PHASE3,197.0,ACTUAL,M.D. Anderson Cancer Center,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,OTHER,,,,,,,2021,1.0
NCT03151681,,2017-04-29,,,2022-12-15,2017-05-11,2017-05-12,ACTUAL,,,,,,,2022-12-15,2022-12-19,ACTUAL,2015-11-01,ACTUAL,2015-11-01,2022-12,2022-12-31,2022-06-06,ACTUAL,2022-06-06,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,,,The Trauma of Betrayal: Treating Adjustment Disorder With Reconsolidation Blockade Under Propranolol,Treating Adjustment Disorders Stemming From Romantic Betrayals: An Open-label Trial of Impairing Memory Reconsolidation Using Propranolol,COMPLETED,,PHASE2/PHASE3,84.0,ACTUAL,Douglas Mental Health University Institute,,3.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 14:19:18.81207,2024-10-15 14:19:18.81207,OTHER,,,,,,,2022,1.0
NCT03093974,,2017-03-09,2023-01-18,,2023-11-14,2017-03-22,2017-03-28,ACTUAL,2023-11-14,2023-11-15,ACTUAL,,,,2023-11-14,2023-11-15,ACTUAL,2017-06-06,ACTUAL,2017-06-06,2023-01,2023-01-31,2021-04-09,ACTUAL,2021-04-09,2021-04-09,ACTUAL,2021-04-09,,INTERVENTIONAL,PROMIS-I,The Intention-To-Treat Population will include all subjects who provided informed consent and received a patient number (randomisation number) whether or not they receive IMP.,Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infection. (PROMIS-I),"Double-blind, Placebo-controlled, Clinical Trial on Efficacy and Safety of 12-months Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With P. Aeruginosa",COMPLETED,,PHASE3,377.0,ACTUAL,Zambon SpA,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,INDUSTRY,,,,,,,2021,1.0
NCT04498182,,2020-07-31,2024-07-10,2022-07-19,2024-08-06,2020-07-31,2020-08-04,ACTUAL,2024-07-10,2024-08-06,ACTUAL,2022-07-19,2022-07-21,ACTUAL,2024-08-06,2024-08-28,ACTUAL,2020-10-26,ACTUAL,2020-10-26,2024-08,2024-08-31,2021-07-17,ACTUAL,2021-07-17,2021-07-17,ACTUAL,2021-07-17,,INTERVENTIONAL,COMET-1,All randomized participants,A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease,A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease (COMET-1),COMPLETED,,PHASE2,369.0,ACTUAL,Aerie Pharmaceuticals,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,INDUSTRY,,,,,,,2021,1.0
NCT04349228,,2020-04-14,,,2020-08-26,2020-04-15,2020-04-16,ACTUAL,,,,,,,2020-08-26,2020-08-28,ACTUAL,2020-04-28,ACTUAL,2020-04-28,2020-08,2020-08-31,2020-07-15,ESTIMATED,2020-07-15,2020-07-15,ESTIMATED,2020-07-15,,INTERVENTIONAL,COVID_2Pro,,Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals,"Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric Randomized Comparative Study",WITHDRAWN,,PHASE3,0.0,ACTUAL,Abderrahmane Mami Hospital,,2.0,,- Interest in the use of HCQ is controversial.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,OTHER,,,,,,,2020,0.0
NCT03469284,,2018-03-13,2022-12-06,,2023-04-20,2018-03-13,2018-03-19,ACTUAL,2023-04-19,2023-04-21,ACTUAL,,,,2023-04-20,2023-04-25,ACTUAL,2019-02-28,ACTUAL,2019-02-28,2023-04,2023-04-30,2022-02-03,ACTUAL,2022-02-03,2022-02-03,ACTUAL,2022-02-03,,INTERVENTIONAL,,,MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN),"Randomized Controlled Trial Comparing 4 Intervention Arms, Including 3 Different Concentrations of Methylene Blue Oral Rinse Combined With Conventional Therapy and Conventional Therapy, in Patients With Intractable Pain Associated With Oral Mucositis",COMPLETED,,PHASE2,69.0,ACTUAL,M.D. Anderson Cancer Center,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,OTHER,,,,,,,2022,1.0
NCT03081052,,2017-03-08,2021-10-05,,2023-02-14,2017-03-14,2017-03-15,ACTUAL,2022-02-14,2022-03-10,ACTUAL,,,,2023-02-14,2023-02-16,ACTUAL,2017-05-04,ACTUAL,2017-05-04,2023-02,2023-02-28,2021-09-05,ACTUAL,2021-09-05,2020-10-05,ACTUAL,2020-10-05,,INTERVENTIONAL,INSPIRE-FLO,"Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment.",Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes,Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes,COMPLETED,,PHASE4,519.0,ACTUAL,Duke University,,4.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,OTHER,,,,,,,2021,1.0
NCT01464164,,2011-10-31,2021-10-12,,2023-02-27,2011-11-02,2011-11-03,ESTIMATED,2021-11-22,2021-12-21,ACTUAL,,,,2023-02-27,2023-03-17,ACTUAL,2012-01,ACTUAL,2012-01-31,2023-02,2023-02-28,2021-04-13,ACTUAL,2021-04-13,2021-04-13,ACTUAL,2021-04-13,,INTERVENTIONAL,ACE-011-DBA,There were no subjects in Cohort 5a at the time of the closure of the study.,Safety and Efficacy Study of Sotatercept in Adults With Transfusion Dependent Diamond Blackfan Anemia,"Phase I/II, Open-Label Study to Determine Safety and Efficacy of Sotatercept (ACE-011) in Adults With Red Blood Cell Transfusion- Dependent Diamond Blackfan Anemia",TERMINATED,,PHASE1/PHASE2,19.0,ACTUAL,Northwell Health,"Early termination of 3 subjects lead to small numbers of subjects analyzed, as does the early closure of the study.~Time to response was unable to be evaluated as no subjects attained response. Response duration was also not evaluated as no subjects responded.",2.0,,Supporter terminated the study due to no active patients (secondary to travel restrictions due to COVID).,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,OTHER,,,,,,,2021,0.0
NCT03759587,,2018-11-29,2020-03-01,,2024-05-23,2018-11-29,2018-11-30,ACTUAL,2020-03-23,2020-03-25,ACTUAL,,,,2024-05-23,2024-06-07,ACTUAL,2018-12-28,ACTUAL,2018-12-28,2024-05,2024-05-31,2022-12-28,ACTUAL,2022-12-28,2019-03-17,ACTUAL,2019-03-17,,INTERVENTIONAL,,Safety Analysis Set included participants who received at least 1 dose of study drug.,Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer,"A Phase 2, Multicenter, Open-label, Single-arm Study to Evaluate the Safety of Niraparib in Japanese Patients With Platinum-sensitive, Relapsed Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Achieved CR or PR in the Last Chemotherapy Containing Platinum-based Anticancer Agents",COMPLETED,,PHASE2,19.0,ACTUAL,Takeda,,1.0,,,f,,,,f,t,f,,,t,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,INDUSTRY,,,,,,,2022,1.0
NCT05342623,,2022-04-18,,,2024-05-06,2022-04-18,2022-04-22,ACTUAL,,,,,,,2024-05-06,2024-05-07,ACTUAL,2022-05-17,ACTUAL,2022-05-17,2024-05,2024-05-31,2024-02-29,ACTUAL,2024-02-29,2024-02-29,ACTUAL,2024-02-29,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus,"A Multicenter, Randomized, Double-blind, Placebo-controlled 12-Week Study to Evaluate the Safety and Efficacy of Oral Difelikefalin in Advanced Chronic Kidney Disease Subjects With Moderate-to-Severe Pruritus With an up to 52-Week Long-term Extension",TERMINATED,,PHASE3,286.0,ACTUAL,"Cara Therapeutics, Inc.",,2.0,,Corporate decision to discontinue work in advanced chronic kidney disease.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,INDUSTRY,,,,,,,2024,0.0
NCT04322604,,2020-03-24,2023-12-13,,2023-12-13,2020-03-25,2020-03-26,ACTUAL,2023-12-13,2024-01-02,ACTUAL,,,,2023-12-13,2024-01-02,ACTUAL,2020-06-18,ACTUAL,2020-06-18,2023-12,2023-12-31,2022-01-12,ACTUAL,2022-01-12,2021-11-29,ACTUAL,2021-11-29,,INTERVENTIONAL,ENIGMA 2,,A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis),"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)",COMPLETED,,PHASE3,181.0,ACTUAL,Allakos Inc.,,2.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,INDUSTRY,,,,,,,2022,1.0
NCT02333344,,2014-10-12,,,2019-09-12,2015-01-06,2015-01-07,ESTIMATED,,,,,,,2019-09-12,2019-09-16,ACTUAL,2015-07-30,ACTUAL,2015-07-30,2019-09,2019-09-30,2020-01-28,ESTIMATED,2020-01-28,2020-01-28,ESTIMATED,2020-01-28,,INTERVENTIONAL,,,The Efficacy Study of Aclasta on Prosthetic Fixation in Postmenopausal Women After THA,"The Efficacy Study of Aclasta (Zoledronic Acid 5mg) on Prosthetic Fixation in Postmenopausal Women After Cementless Total Hip Arthroplasty (THA): a 24 Months, Single Center, Open- Label, Randomized, Parallel Controlled Study",WITHDRAWN,,PHASE4,0.0,ACTUAL,Novartis,,2.0,,"Study halted prematurely, prior to enrollment of first participant, for strategic reasons",f,,,,f,,,,,,,,,,,,,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,INDUSTRY,,,,,,,2020,0.0
NCT04751955,,2021-02-04,,,2023-10-29,2021-02-08,2021-02-12,ACTUAL,,,,,,,2023-10-29,2023-10-31,ACTUAL,2022-01-01,ESTIMATED,2022-01-01,2023-10,2023-10-31,2024-08-31,ESTIMATED,2024-08-31,2023-10-31,ESTIMATED,2023-10-31,,INTERVENTIONAL,,,"A Phase lb/ll, Open Label, Single Arm Study With Olinvacimab and Capecitabine in mCRC Patients (OLCAP)","A Phase lb/ll, Multicenter, Open Label, Single Arm Study to Assess the Safety and Efficacy of the Anti-VEGFR2 Monoclonal Antibody Olinvacimab and the Capecitabine in Patients With mCRC Who Failed Two Prior Chemotherapies",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Korean Cancer Study Group,,1.0,,This clinical trial was not finally approved by the Korea FDA.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,OTHER,,,,,,,2024,0.0
NCT04349280,,2020-04-15,2023-08-14,,2024-04-12,2020-04-15,2020-04-16,ACTUAL,2024-04-12,2024-04-18,ACTUAL,,,,2024-04-12,2024-04-18,ACTUAL,2020-10-15,ACTUAL,2020-10-15,2024-04,2024-04-30,2022-08-15,ACTUAL,2022-08-15,2022-08-15,ACTUAL,2022-08-15,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer,A Phase Ib Trial to Evaluate the Efficacy and Safety of Bintrafusp Alfa Monotherapy in Metastatic or Locally Advanced/Unresectable Urothelial Cancer With Disease Progression or Recurrence Following Treatment With a Platinum Agent,TERMINATED,,PHASE1,25.0,ACTUAL,GlaxoSmithKline,,1.0,,Primary investigator withdrew the participant due to an SAE,f,,,,f,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,INDUSTRY,,,,,,,2022,0.0
NCT02040857,,2014-01-13,2020-06-30,,2024-02-20,2014-01-17,2014-01-20,ESTIMATED,2020-12-01,2020-12-23,ACTUAL,,,,2024-02-20,2024-02-22,ACTUAL,2014-01,,2014-01-31,2024-02,2024-02-29,2020-05,ACTUAL,2020-05-31,2018-05,ACTUAL,2018-05-31,,INTERVENTIONAL,,,"Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer",A Phase 2 Pilot Feasibility Study of Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive Invasive Breast Carcinoma,COMPLETED,,PHASE2,162.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,OTHER,,,,,,,2020,1.0
NCT03291886,,2017-09-14,,,2022-06-15,2017-09-21,2017-09-25,ACTUAL,,,,,,,2022-06-15,2022-06-21,ACTUAL,2017-09-22,ACTUAL,2017-09-22,2022-06,2022-06-30,2021-03-26,ACTUAL,2021-03-26,2019-04-04,ACTUAL,2019-04-04,,INTERVENTIONAL,,,Phase 2 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer,Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer,COMPLETED,,PHASE2,133.0,ACTUAL,"Kyowa Kirin Co., Ltd.",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,INDUSTRY,,,,,,,2021,1.0
NCT02639182,,2015-12-21,2020-08-20,,2021-11-09,2015-12-23,2015-12-24,ESTIMATED,2020-09-21,2020-09-23,ACTUAL,,,,2021-11-09,2021-11-10,ACTUAL,2016-05-03,ACTUAL,2016-05-03,2021-11,2021-11-30,2020-10-02,ACTUAL,2020-10-02,2020-10-02,ACTUAL,2020-10-02,,INTERVENTIONAL,,Full Analysis Set (FAS): All participants who were randomized to study drug.,A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma,"A Multi-Center, Open Label, Randomized Phase 2 Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma",COMPLETED,,PHASE2,133.0,ACTUAL,Astellas Pharma Inc,,2.0,,,f,,,,t,t,f,,,,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://www.clinicalstudydatarequest.com/,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-16 10:28:16.619721,2024-10-16 10:28:16.619721,INDUSTRY,,,,,,,2020,1.0
NCT04227704,,2019-11-20,2022-08-16,,2023-01-06,2020-01-13,2020-01-14,ACTUAL,2023-01-06,2023-01-26,ACTUAL,,,,2023-01-06,2023-01-26,ACTUAL,2020-11-12,ACTUAL,2020-11-12,2023-01,2023-01-31,2021-08-09,ACTUAL,2021-08-09,2021-08-09,ACTUAL,2021-08-09,,INTERVENTIONAL,PoCKet,,Ketamine to Prevent PPD After Cesarean,Postpartum Depression After Cesarean Delivery: Ketamine as a Preventative Intervention: A Feasibility Pilot-study,COMPLETED,,PHASE3,25.0,ACTUAL,Washington University School of Medicine,,3.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,OTHER,,,,,,,2021,1.0
NCT02908165,,2016-09-06,,,2018-01-08,2016-09-15,2016-09-20,ESTIMATED,,,,,,,2018-01-08,2018-01-10,ACTUAL,2016-06,,2016-06-30,2018-01,2018-01-31,2020-06,ESTIMATED,2020-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,Randomized Phase II Trial of Chemoembolization and Sorafenib,Randomized Phase II Trial of Chemoembolization and Sorafenib: Comparison Between Continuous and Sequential Treatment Regimens,WITHDRAWN,,PHASE2,0.0,ACTUAL,Yale University,,2.0,,A future study will be taking place using the same patient population.,f,,,,f,,,,,,,,,,,NO,,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,OTHER,,,,,,,2020,0.0
NCT03580005,,2018-05-16,,,2018-10-30,2018-07-05,2018-07-09,ACTUAL,,,,,,,2018-10-30,2018-11-01,ACTUAL,2018-10-31,ESTIMATED,2018-10-31,2018-10,2018-10-31,2021-10-12,ESTIMATED,2021-10-12,2021-10-12,ESTIMATED,2021-10-12,,INTERVENTIONAL,,,A 6-week Study to Evaluate the Safety and Efficacy of Quillichew ERCT in 4-5 Year Old Children With ADHD.,"A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Quillichew (Methylphenidate Hydrochloride (Hcl)) Extended Release Chewable Tablets (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)",WITHDRAWN,,PHASE4,0.0,ACTUAL,Pfizer,,2.0,,The study was cancelled prior to the enrollment of any participants.,f,,,,t,t,f,,,,,,,,,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests,2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,INDUSTRY,,,,,,,2021,0.0
NCT04677829,,2020-12-06,,,2022-06-23,2020-12-16,2020-12-21,ACTUAL,,,,,,,2022-06-23,2022-06-29,ACTUAL,2021-03-29,ACTUAL,2021-03-29,2022-06,2022-06-30,2021-04-12,ACTUAL,2021-04-12,2021-04-12,ACTUAL,2021-04-12,,INTERVENTIONAL,,,Safety and Tolerability of PNT001 in Patients With Acute Traumatic Brain Injury (TBI),"Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Trial to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Intravenous PNT001 in Hospitalized Patients With Traumatic Brain Injury (TBI)",TERMINATED,,PHASE1,1.0,ACTUAL,"Pinteon Therapeutics, Inc",,3.0,,"The study was terminated due to administrative, non-safety related reasons.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,INDUSTRY,,,,,,,2021,0.0
NCT02596971,,2015-11-03,2019-04-09,,2021-04-26,2015-11-03,2015-11-04,ESTIMATED,2019-05-21,2019-06-13,ACTUAL,,,,2021-04-26,2021-05-24,ACTUAL,2015-12-22,ACTUAL,2015-12-22,2021-04,2021-04-30,2020-05-08,ACTUAL,2020-05-08,2018-04-11,ACTUAL,2018-04-11,,INTERVENTIONAL,,"3 populations for the Atezo-G-Benda cohort: safety, efficacy, and pharmacokinetic (PK). All participants (n = 42) in Atezo-G-Benda cohort included in safety and positron emission tomography (PET) evaluable populations. Two participants were excluded from efficacy evaluable population due to diagnosis of relapsed/ refractory follicular lymphoma (r/r FL). All 42 FL participants in Atezo-G-Benda cohort included in PK evaluable population.","A Study of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus (+) Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Follicular Lymphoma (FL) or Rituximab + CHOP in Participants With Diffuse Large B-Cell Lymphoma (DLBCL)",A Phase IB/II Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus CHOP in Patients With Follicular Lymphoma or Rituximab Plus CHOP in Patients With Diffuse Large B-Cell Lymphoma,COMPLETED,,PHASE1/PHASE2,91.0,ACTUAL,Hoffmann-La Roche,Development of the atezolizumab combination treatment was discontinued as there was insufficient evidence regarding the additive efficacy of this therapy.,3.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,INDUSTRY,,,,,,,2020,0.0
NCT04104919,,2019-09-24,,,2020-07-09,2019-09-24,2019-09-26,ACTUAL,,,,,,,2020-07-09,2020-07-13,ACTUAL,2021-01,ESTIMATED,2021-01-31,2020-07,2020-07-31,2022-02,ESTIMATED,2022-02-28,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,,,Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Mastectomy in Patients With High PCS Scores,"A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Intrathecal Preoperative Administration of Brivoligide Injection in Patients With a Pain Catastrophizing Scale Score ≥16 Undergoing Mastectomy With Immediate Tissue Expander or Implant Placement",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Adynxx, Inc.",,2.0,,Study Initiation delayed due to COVID 19,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:24:31.492927,2024-10-15 00:24:31.492927,INDUSTRY,,,,,,,2022,0.0
NCT03220399,,2017-06-30,,,2019-08-21,2017-07-17,2017-07-18,ACTUAL,,,,,,,2019-08-21,2019-08-26,ACTUAL,2019-12-01,ESTIMATED,2019-12-01,2019-08,2019-08-31,2020-07-31,ESTIMATED,2020-07-31,2020-03-28,ESTIMATED,2020-03-28,,INTERVENTIONAL,,,Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2,Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2 in Healthy Male Volunteers,WITHDRAWN,,PHASE1,0.0,ACTUAL,NVP Healthcare,,3.0,,Decided to stop drug development,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,INDUSTRY,,,,,,,2020,0.0
NCT04089904,,2019-08-20,2024-03-08,,2024-05-13,2019-09-12,2019-09-13,ACTUAL,2024-05-13,2024-05-20,ACTUAL,,,,2024-05-13,2024-05-20,ACTUAL,2019-10-11,ACTUAL,2019-10-11,2024-05,2024-05-31,2023-03-11,ACTUAL,2023-03-11,2023-03-11,ACTUAL,2023-03-11,,INTERVENTIONAL,,,Phase II Trial of Neoadjuvant Pembrolizumab for Patients With Early Stage Gastroesophageal Adenocarcinoma,A Phase II Trial of Neoadjuvant Pembrolizumab for Resectable Early Stage Gastroesophageal Adenocarcinoma,TERMINATED,,PHASE2,3.0,ACTUAL,University of Chicago,,1.0,,Low accrual.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,OTHER,,,,,,,2023,0.0
NCT03035058,,2017-01-25,,,2017-03-07,2017-01-25,2017-01-27,ESTIMATED,,,,,,,2017-03-07,2017-03-08,ACTUAL,2017-02,,2017-02-28,2017-03,2017-03-31,2021-01,ESTIMATED,2021-01-31,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,Efficacy and Safety of Vedolizumab Intravenous (IV) in the Treatment of Primary Sclerosing Cholangitis in Subjects With Underlying Inflammatory Bowel Disease,"A Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Vedolizumab IV for the Treatment of Primary Sclerosing Cholangitis, With Underlying Inflammatory Bowel Disease",WITHDRAWN,,PHASE3,0.0,ACTUAL,Takeda,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,INDUSTRY,,,,,,,2021,0.0
NCT04315051,,2020-03-12,,,2021-06-16,2020-03-18,2020-03-19,ACTUAL,,,,,,,2021-06-16,2021-06-18,ACTUAL,2019-09-12,ACTUAL,2019-09-12,2021-02,2021-02-28,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,A Trial of Safety/Efficacy of Test Article in Patients With Interdigital T. Pedis,"Clinical Trial Protocol DBI-204 Double-Blind, Randomized, Placebo Controlled Trial of the Safety and Efficacy of DBI-001 Gel in Patients With Interdigital Tinea Pedis",TERMINATED,,PHASE2,39.0,ACTUAL,"DermBiont, Inc.",,2.0,,Covid- 19 has shut the clinic,f,,,,t,f,f,,,,,,,,,,,2024-10-16 00:45:45.493002,2024-10-16 00:45:45.493002,INDUSTRY,,,,,,,2020,0.0
NCT05284604,,2022-03-08,,,2023-02-02,2022-03-16,2022-03-17,ACTUAL,,,,,,,2023-02-02,2023-02-06,ACTUAL,2023-01-31,ACTUAL,2023-01-31,2023-02,2023-02-28,2023-01-31,ACTUAL,2023-01-31,2023-01-31,ACTUAL,2023-01-31,,INTERVENTIONAL,MESCAFY,,Mesenchymal Stem Cells for Age-Related Frailty,A Pilot Study of Mesenchymal Stem Cells as Novel Therapy for Age-Related Frailty in Veterans,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,VA Office of Research and Development,,3.0,,Insufficient funding,f,,,,t,t,f,,,t,,,,,,NO,"MEDVAMC will not provide unrestricted, open public access to large scale health related datasets because of re-identification concerns and the obligation to protect Veterans' private information. However, controlled public access will be provided to the greatest extent possible under specific DUAs or other written agreements, and open access will be provided to the final datasets underlying peer-reviewed publications (aggregated data that can be released with privacy and confidentiality risks).",2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,FED,,,,,,,2023,0.0
NCT04868045,,2021-04-28,,,2023-02-16,2021-04-29,2021-04-30,ACTUAL,,,,,,,2023-02-16,2023-02-21,ACTUAL,2021-04-27,ACTUAL,2021-04-27,2023-02,2023-02-28,2023-02-15,ACTUAL,2023-02-15,2023-02-15,ACTUAL,2023-02-15,,INTERVENTIONAL,,,Study of Resistance to Thyroid Hormone After Long-term Exposure in People With Thyroid Cancer,Evaluation of The Development of Central Resistance to Thyroid Hormone After Prolonged Exposure to Excess Thyroid Hormone in Thyroid Cancer Patients,WITHDRAWN,,PHASE1,0.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,2.0,,Lack of accrual,,,,,,t,f,,,,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,OTHER,,,,,,,2023,0.0
NCT03941873,,2018-12-23,,,2023-04-10,2019-05-07,2019-05-08,ACTUAL,,,,,,,2023-04-10,2023-04-12,ACTUAL,2019-02-28,ACTUAL,2019-02-28,2023-04,2023-04-30,2023-03-31,ACTUAL,2023-03-31,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,,,A Study to Investigate Sitravatinib as Monotherapy and in Combination With Tislelizumab in Participants With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) or Gastric/Gastroesophageal Junction Cancer (GC/GEJC),"A Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib as Monotherapy and in Combination With Tislelizumab in Patients With Unresectable Locally Advanced or Metastatic HCC or GC/GEJC",COMPLETED,,PHASE1/PHASE2,111.0,ACTUAL,BeiGene,,6.0,,,f,,,,f,f,f,,,t,,,,,,YES,,2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,INDUSTRY,,,,,,,2023,1.0
NCT04382924,,2020-05-08,2021-11-22,,2021-12-01,2020-05-08,2020-05-11,ACTUAL,2021-12-01,2021-12-03,ACTUAL,,,,2021-12-01,2021-12-03,ACTUAL,2020-08-05,ACTUAL,2020-08-05,2021-12,2021-12-31,2021-01-26,ACTUAL,2021-01-26,2020-12-24,ACTUAL,2020-12-24,,INTERVENTIONAL,,,Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patient With Confirmed COVID-19 Disease,A Randomized Open Label Phase 2b/3 Study of the Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patient With Confirmed COVID-19 Disease,COMPLETED,,PHASE2/PHASE3,168.0,ACTUAL,Algernon Pharmaceuticals,,3.0,,,,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,INDUSTRY,,,,,,,2021,1.0
NCT04235036,,2019-08-19,,,2023-11-07,2020-01-17,2020-01-21,ACTUAL,,,,,,,2023-11-07,2023-11-09,ACTUAL,2019-12-16,ACTUAL,2019-12-16,2023-11,2023-11-30,2022-12-23,ACTUAL,2022-12-23,2022-12-23,ACTUAL,2022-12-23,,INTERVENTIONAL,,,Ibrutinib and Rituxan for Chronic GVHD,Phase II Trial Evaluating the Safety and Efficacy of Combined CD20- and BTK-Targeted B Cell Depleting Therapy With Rituximab and Ibrutinib in the Primary Treatment of Chronic Graft-Versus-Host Disease,TERMINATED,,PHASE2,19.0,ACTUAL,"Northside Hospital, Inc.",,1.0,,Low Recruitment,,,,,,t,f,,,,,,,,,NO,,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,OTHER,,,,,,,2022,0.0
NCT03587142,,2018-07-02,2023-04-13,,2023-06-14,2018-07-02,2018-07-16,ACTUAL,2023-06-14,2023-06-15,ACTUAL,,,,2023-06-14,2023-06-15,ACTUAL,2019-08-27,ACTUAL,2019-08-27,2023-06,2023-06-30,2022-04-30,ACTUAL,2022-04-30,2022-04-15,ACTUAL,2022-04-15,,INTERVENTIONAL,BESST,,Buspirone for Early Satiety and Symptoms of Gastroparesis,"Buspirone for Early Satiety and Symptoms of Gastroparesis: A Multicenter, Randomized, Placebo-Controlled, Double-Masked Trial (BESST)",COMPLETED,,PHASE2,96.0,ACTUAL,Johns Hopkins Bloomberg School of Public Health,,2.0,,,f,,,,t,t,f,,,t,,,The analytic datasets to produce the primary result manuscript will be submitted within one year of publication of the primary result manuscript. The full clinical dataset for all Clinical Study Reports (CSRs) without proprietary restrictions will be submitted within 2 years of the primary result manuscript publication. This data will be available publicly indefinitely.,An investigator interested in acquiring BESST study data should contact the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository at https://www.niddkrepository.org/search/study/ and apply to obtain the data required for their study.,https://repository.niddk.nih.gov/home/,YES,"The study will comply with the NIH Data Sharing Policy. The data will be first de-identified so that no individual participant identifiers will be included in the dataset (no names, addresses, dates, comments, etc). If a characteristic is an extreme value for this population, then those values will be categorized into one frequency group. If a CSR has multiple versions, then all data will be recoded into the format of the most current form version. A random unique identification number will be substituted for the unique BESST identification number. If a clinical item was obtained from surveys with restrictions due to licensing, then that data will be excluded. The data will be shared in 2 stages: the first will be the analytic datasets to produce the primary outcome paper. For this dataset, the documentation will include analytic code. The full dataset by CSR will be provided in the second stage.",2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,OTHER,,,,,,,2022,1.0
NCT03088709,,2017-02-22,,,2024-07-09,2017-03-17,2017-03-23,ACTUAL,,,,,,,2024-07-09,2024-07-10,ACTUAL,2017-01-18,ACTUAL,2017-01-18,2024-07,2024-07-31,2022-01-31,ACTUAL,2022-01-31,2022-01-31,ACTUAL,2022-01-31,,INTERVENTIONAL,,,Haploidentical Stem Cell Transplantation Using Post-Transplant Cyclophosphamide,"Safety, Efficacy and Feasibility of Haploidentical Stem Cell Transplantation (Haplo-SCT) Using Post-Transplant Cyclophosphamide (PTCy) as an Alternative Donor Source for Patients Who Lack a Matched Sibling/Unrelated Donor Options",TERMINATED,,PHASE2,5.0,ACTUAL,Loyola University,,1.0,,Poor accrual,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,OTHER,,,,,,,2022,0.0
NCT05898828,,2023-06-09,,,2024-08-02,2023-06-09,2023-06-12,ACTUAL,,,,,,,2024-08-02,2024-08-05,ACTUAL,2024-08-02,ACTUAL,2024-08-02,2024-08,2024-08-31,2024-08-02,ACTUAL,2024-08-02,2024-08-02,ACTUAL,2024-08-02,,INTERVENTIONAL,,,Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With Entinostat and Nivolumab as Adjuvant Therapy Following Chemoradiation Therapy With or Without Surgery for Locally Advanced Esophageal Cancer,Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With Entinostat and Nivolumab as Adjuvant Therapy Following Chemoradiation Therapy With or Without Surgery for Locally Advanced Esophageal Cancer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,No enrollment,f,,,,,t,f,,,,,,Data from this study may be requested from other researchers after the trial has been completed and closed.,Data from this study may be requested by contacting the PI.,,YES,.All IPD recorded will be shared upon request.,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,NIH,,,,,,,2024,0.0
NCT04425902,,2020-06-05,2022-03-03,,2023-12-22,2020-06-05,2020-06-11,ACTUAL,2022-03-03,2022-05-23,ACTUAL,,,,2023-12-22,2024-01-05,ACTUAL,2020-12-16,ACTUAL,2020-12-16,2023-12,2023-12-31,2021-03-10,ACTUAL,2021-03-10,2021-03-10,ACTUAL,2021-03-10,,INTERVENTIONAL,,Safety Population consisted of all participants who received at least 1 dose of study medication.,"Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults","Effects of GSK3640254 on the Single-Dose Pharmacokinetics of Probe Substrates (Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin) in Healthy Subjects",COMPLETED,,PHASE1,20.0,ACTUAL,ViiV Healthcare,,1.0,,,f,,,,f,t,f,,,,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/,YES,Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,INDUSTRY,,,,,,,2021,1.0
NCT03809663,,2019-01-10,2022-01-25,2021-02-18,2022-03-09,2019-01-17,2019-01-18,ACTUAL,2022-03-09,2022-03-10,ACTUAL,2022-03-09,2022-03-10,ACTUAL,2022-03-09,2022-03-10,ACTUAL,2019-03-15,ACTUAL,2019-03-15,2022-03,2022-03-31,2020-12-22,ACTUAL,2020-12-22,2020-05-12,ACTUAL,2020-05-12,,INTERVENTIONAL,,Full analysis set (FAS): All randomized participants in Part A.,A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis,"A Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tezepelumab Alone or Combined With Topical Corticosteroids in Moderate-to-Severe Atopic Dermatitis",TERMINATED,,PHASE2,251.0,ACTUAL,Amgen,Enrollment of Part A of this study was completed as of 27 July 2020. The study was terminated prior to the enrollment of any participants into Part B.,6.0,,Tezepelumab as a monotherapy in atopic dermatitis did not reach the targeted efficacy level pre-established for this patient population.,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,INDUSTRY,,,,,,,2020,0.0
NCT02960113,,2016-11-07,2022-08-07,,2022-11-25,2016-11-07,2016-11-09,ESTIMATED,2022-11-25,2022-12-28,ACTUAL,,,,2022-11-25,2022-12-28,ACTUAL,2016-05,ACTUAL,2016-05-31,2022-11,2022-11-30,2021-09,ACTUAL,2021-09-30,2021-09,ACTUAL,2021-09-30,,INTERVENTIONAL,,,Scopolamine Patch and Acupressure Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean Section,Is the Application of Scopolamine Patch With or Without Intra-operative Acupressure Point P6 Stimulation More Effective Than Intra-operative Acupressure Point P6 Stimulation Alone?,COMPLETED,,PHASE4,240.0,ACTUAL,"Rutgers, The State University of New Jersey",,3.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,OTHER,,,,,,,2021,1.0
NCT04631601,,2020-11-13,,2024-08-27,2024-08-27,2020-11-13,2020-11-17,ACTUAL,,,,,2023-11-07,ACTUAL,2024-08-27,2024-08-29,ACTUAL,2021-01-15,ACTUAL,2021-01-15,2024-08,2024-08-31,2023-10-23,ACTUAL,2023-10-23,2023-10-23,ACTUAL,2023-10-23,,INTERVENTIONAL,,,Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC),A Master Protocol Evaluating the Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC),TERMINATED,,PHASE1/PHASE2,65.0,ACTUAL,Amgen,,11.0,,Amgen made a business decision to discontinue all AMG 160 clinical trials. This decision is not related to safety.,f,,,,,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,INDUSTRY,,,,,,,2023,0.0
NCT02478710,,2015-04-30,2022-07-27,,2023-05-26,2015-06-17,2015-06-23,ESTIMATED,2023-04-25,2023-05-22,ACTUAL,,,,2023-05-26,2023-05-31,ACTUAL,2015-06,,2015-06-30,2023-05,2023-05-31,2022-07,ACTUAL,2022-07-31,2017-02,ACTUAL,2017-02-28,,INTERVENTIONAL,AAINTVAP,,Aerosolized Antibiotics in the Treatment of Ventilator Associated Pneumonia,Aerosolized Antibiotics in the Treatment of Ventilator Associated Pneumonia: A Pilot Study,TERMINATED,,PHASE4,16.0,ACTUAL,Wright State University,Data was not collected for the Secondary Outcomes.,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,OTHER,,,,,,,2022,0.0
NCT01028716,,2009-12-08,2022-10-06,,2023-01-04,2009-12-08,2009-12-09,ESTIMATED,2023-01-04,2023-01-23,ACTUAL,,,,2023-01-04,2023-01-23,ACTUAL,2010-05-19,ACTUAL,2010-05-19,2023-01,2023-01-31,2021-10-07,ACTUAL,2021-10-07,2021-10-07,ACTUAL,2021-10-07,,INTERVENTIONAL,,,Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies,"Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Phase II Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source",TERMINATED,,PHASE2,46.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,The study experienced lower accrual rates after the onset of COVID. Upon review of the collected data it was deemed that an adequate amount of subjects has been enrolled to date to assess study aims.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,OTHER,,,,,,,2021,0.0
NCT04267679,,2020-02-06,,,2020-12-17,2020-02-10,2020-02-13,ACTUAL,,,,,,,2020-12-17,2020-12-19,ACTUAL,2020-03-01,ACTUAL,2020-03-01,2020-12,2020-12-31,2020-12-01,ACTUAL,2020-12-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,,,Cannabidiol for Anxiety,Prospective Evaluation of Cannabidiol (CBD) on Anxiety: A Pilot Study,WITHDRAWN,,PHASE2,0.0,ACTUAL,CB2 Insights,,1.0,,Stopped due to COVID-19 pandemic.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,OTHER,,,,,,,2020,0.0
NCT05472506,,2022-07-20,,,2024-03-14,2022-07-22,2022-07-25,ACTUAL,,,,,,,2024-03-14,2024-03-15,ACTUAL,2023-03,ESTIMATED,2023-03-31,2024-03,2024-03-31,2023-04,ESTIMATED,2023-04-30,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,,,Oral AHR Antagonist in Combination With Nivolumab in Patients With PD-1 Resistant Metastatic or Recurrent Head and Neck Cancer,"A Phase 1b, Open-Label, Single-Arm Dose-Expansion Study of IK-175, an Oral Aryl Hydrocarbon Receptor Inhibitor, in Combination With Nivolumab in Patients With Primary PD-1 Inhibitor Resistant Metastatic or Locally Incurable, Recurrent HNSCC",WITHDRAWN,,PHASE1,0.0,ACTUAL,Ikena Oncology,,2.0,,Sponsor Decision,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,INDUSTRY,,,,,,,2023,0.0
NCT04194203,,2019-12-09,,,2024-07-18,2019-12-09,2019-12-11,ACTUAL,,,,,,,2024-07-18,2024-07-19,ACTUAL,2020-04-09,ACTUAL,2020-04-09,2024-07,2024-07-31,2024-06-27,ACTUAL,2024-06-27,2023-02-02,ACTUAL,2023-02-02,,INTERVENTIONAL,,,"A Study of Bevacizumab, Carboplatin, and Paclitaxel or Pemetrexed With or Without Atezolizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (IMpower151)","A Phase III, Randomized, Double-Blind Study of Bevacizumab, Carboplatin, and Paclitaxel or Pemetrexed With or Without Atezolizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (IMpower151)",COMPLETED,,PHASE3,305.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,f,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,INDUSTRY,,,,,,,2024,0.0
NCT05060276,,2021-08-20,,,2023-01-24,2021-09-17,2021-09-29,ACTUAL,,,,,,,2023-01-24,2023-01-26,ACTUAL,2022-12,ESTIMATED,2022-12-31,2023-01,2023-01-31,2024-12,ESTIMATED,2024-12-31,2024-05,ESTIMATED,2024-05-31,,INTERVENTIONAL,,,Study to Assess an Anti-Trop2 Antibody Drug Conjugate in Relapsed or Refractory Solid Tumors,"A Phase 1B, Dose-Escalation Study of the Safety and Preliminary Efficacy of an Anti-Trop2 Antibody Drug Conjugate (STI-3258) in Patients With Relapsed or Refractory Solid Tumors",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,1.0,,Protocol changed to Phase 2,f,,,,,t,f,,,,,,,,,,,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,INDUSTRY,,,,,,,2024,0.0
NCT04025567,,2019-07-18,,,2020-03-13,2019-07-18,2019-07-19,ACTUAL,,,,,,,2020-03-13,2020-03-16,ACTUAL,2020-03-12,ESTIMATED,2020-03-12,2020-03,2020-03-31,2021-12-31,ESTIMATED,2021-12-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Vancomycin in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLC) Oral,Phase II Study of Oral Vancomycin in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLC),WITHDRAWN,,PHASE2,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,slow/insufficient accrual.,f,,,,,f,f,,,,,,,,,,,2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,NIH,,,,,,,2021,0.0
NCT04074590,,2019-08-29,2023-10-18,,2024-06-17,2019-08-29,2019-08-30,ACTUAL,2023-10-18,2023-11-09,ACTUAL,,,,2024-06-17,2024-06-20,ACTUAL,2020-02-03,ACTUAL,2020-02-03,2024-06,2024-06-30,2022-11-07,ACTUAL,2022-11-07,2022-11-07,ACTUAL,2022-11-07,,INTERVENTIONAL,,,"Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis","A Randomized, Multi-center, Subject and Investigator-blinded, Placebo-controlled, Parallel-group Study to Assess the Efficacy Safety and Tolerability of LYS006 in Patients With Mild to Moderate Ulcerative Colitis",TERMINATED,,PHASE2,23.0,ACTUAL,Novartis,,2.0,,Sponsor decision due to strategic considerations,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,INDUSTRY,,,,,,,2022,0.0
NCT03648372,,2018-08-24,,,2024-02-09,2018-08-24,2018-08-27,ACTUAL,,,,,,,2024-02-09,2024-02-12,ACTUAL,2018-10-01,ACTUAL,2018-10-01,2024-02,2024-02-29,2023-12-18,ACTUAL,2023-12-18,2023-11-22,ACTUAL,2023-11-22,,INTERVENTIONAL,,,A Study of TAK-981 in People With Advanced Solid Tumors or Cancers in the Immune System,"An Open Label, Dose-Escalation, Phase 1/2 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of TAK-981 in Adult Patients With Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies",TERMINATED,,PHASE1/PHASE2,109.0,ACTUAL,Takeda,,7.0,,Enrolment Challenges,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,INDUSTRY,,,,,,,2023,0.0
NCT04601077,,2020-10-21,,,2022-12-02,2020-10-22,2020-10-23,ACTUAL,,,,,,,2022-12-02,2022-12-06,ACTUAL,2020-11-01,ACTUAL,2020-11-01,2022-12,2022-12-31,2022-11-30,ACTUAL,2022-11-30,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,,,The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin,Pilot Study: The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin,TERMINATED,,PHASE1/PHASE2,524.0,ACTUAL,Nitric Oxide Innovations LLC,,2.0,,The study stopped due to futility.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,INDUSTRY,,,,,,,2022,0.0
NCT03300570,,2017-10-02,2019-11-07,,2021-05-19,2017-10-02,2017-10-03,ACTUAL,2019-12-04,2019-12-17,ACTUAL,,,,2021-05-19,2021-06-14,ACTUAL,2018-07-27,ACTUAL,2018-07-27,2021-05,2021-05-31,2021-05-17,ACTUAL,2021-05-17,2019-01-02,ACTUAL,2019-01-02,,INTERVENTIONAL,,,Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers,"Phase I Double-Blind, Placebo-Controlled Trial of 27 mg Dolcanatide (SP-333) to Demonstrate Colorectal Bioactivity in Healthy Volunteers",COMPLETED,,PHASE1,27.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,,,,,t,t,f,,,,,,,,,,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,NIH,,,,,,,2021,1.0
NCT03397134,,2017-12-29,2022-12-09,2021-01-05,2023-04-26,2018-01-05,2018-01-11,ACTUAL,2023-04-26,2023-04-28,ACTUAL,,2023-04-28,ACTUAL,2023-04-26,2023-04-28,ACTUAL,2017-12-15,ACTUAL,2017-12-15,2023-04,2023-04-30,2021-02-15,ACTUAL,2021-02-15,2020-05-26,ACTUAL,2020-05-26,,INTERVENTIONAL,,Patients who Started Treatment.,Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia,"A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, 12-Week Study to Evaluate the Efficacy and Safety of 2 Fixed Doses of MIN-101 in Adult Patients With Negative Symptoms of Schizophrenia, Followed by a 40-Week Open-Label Extension",COMPLETED,,PHASE3,515.0,ACTUAL,Minerva Neurosciences,,4.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,INDUSTRY,,,,,,,2021,1.0
NCT02536300,,2015-08-27,2023-06-30,,2023-08-09,2015-08-27,2015-08-31,ESTIMATED,2023-08-09,2023-08-14,ACTUAL,,,,2023-08-09,2023-08-14,ACTUAL,2016-01-14,ACTUAL,2016-01-14,2023-08,2023-08-31,2022-09-27,ACTUAL,2022-09-27,2022-09-27,ACTUAL,2022-09-27,,INTERVENTIONAL,,Safety analysis set included all participants who received at least 1 dose of study drug.,Dose Optimization Study of Idelalisib in Follicular Lymphoma,Dose Optimization Study of Idelalisib in Follicular Lymphoma,TERMINATED,,PHASE3,96.0,ACTUAL,Gilead Sciences,,3.0,,Gilead has made the decision to close the study due to enrollment challenges,f,,,,t,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gileadclinicaltrials.com/transparency-policy/,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/",2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,INDUSTRY,,,,,,,2022,0.0
NCT03110445,,2016-05-11,,,2020-02-05,2017-04-11,2017-04-12,ACTUAL,,,,,,,2020-02-05,2020-02-07,ACTUAL,2020-03,ESTIMATED,2020-03-31,2020-02,2020-02-29,2021-09,ESTIMATED,2021-09-30,2021-09,ESTIMATED,2021-09-30,,INTERVENTIONAL,rVV-740CTA,,Cancer/Testis Antigen Immunotherapy Phase I Study With 740-CTA Vaccinia Virus,Monocentric Open Label Phase I Immunotherapy Trial of Breast Cancer Patients With a Non-replicating Recombinant Vaccinia Virus Expressing Cancer/Testis Antigens and Cluster of Differentiation Antigen 80 (CD80)-CD40L Costimulatory Molecules.,WITHDRAWN,,PHASE1,0.0,ACTUAL,"University Hospital, Basel, Switzerland",,1.0,,not sufficiently staff available to perform trial,f,,,,f,f,f,,,,,,,,,NO,publication per reviewed journal,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,OTHER,,,,,,,2021,0.0
NCT05203367,,2021-12-04,,,2024-06-17,2022-01-05,2022-01-24,ACTUAL,,,,,,,2024-06-17,2024-06-20,ACTUAL,2022-11-25,ESTIMATED,2022-11-25,2024-06,2024-06-30,2023-03-30,ESTIMATED,2023-03-30,2023-03-30,ESTIMATED,2023-03-30,,INTERVENTIONAL,,,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BAR 502 in Healthy Subjects","Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of BAR 502 in Healthy Subjects",WITHDRAWN,,PHASE1,0.0,ACTUAL,BAR Pharmaceuticals s.r.l.,,2.0,,Update development program,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,NETWORK,,,,,,,2023,0.0
NCT03745352,,2018-11-16,,,2023-06-23,2018-11-16,2018-11-19,ACTUAL,,,,,,,2023-06-23,2023-06-27,ACTUAL,2019-05-20,ESTIMATED,2019-05-20,2022-06,2022-06-30,2021-08-19,ESTIMATED,2021-08-19,2021-08-19,ESTIMATED,2021-08-19,,INTERVENTIONAL,,,Pevonedistat With Azacitidine Versus Azacitidine Alone in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia,A Randomized Phase II Trial of MLN4924 (Pevonedistat) With Azacitidine Versus Azacitidine in Adult Relapsed or Refractory Acute Myeloid Leukemia,WITHDRAWN,,PHASE2,0.0,ACTUAL,National Cancer Institute (NCI),,2.0,,Inadequate accrual rate,f,,,,t,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page",2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,NIH,,,,,,,2021,0.0
NCT06254118,,2024-01-28,,,2024-02-08,2024-02-08,2024-02-12,ACTUAL,,,,,,,2024-02-08,2024-02-12,ACTUAL,2020-01-22,ACTUAL,2020-01-22,2024-02,2024-02-29,2023-01-30,ACTUAL,2023-01-30,2022-01-22,ACTUAL,2022-01-22,,INTERVENTIONAL,,,Treatment of Periodontitis in Menopausal Patients,Non-Surgical Treatment of Periodontitis in Menopausal Patients,COMPLETED,,PHASE4,20.0,ACTUAL,King Abdulaziz University,,2.0,,,f,,,,f,f,f,,,f,,,,,,NO,no IPD to be shared,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,OTHER,,,,,,,2023,1.0
NCT03787082,,2018-12-24,,,2022-07-05,2018-12-24,2018-12-26,ACTUAL,,,,,,,2022-07-05,2022-07-07,ACTUAL,2022-12,ESTIMATED,2022-12-31,2022-07,2022-07-31,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Chlorhexidine Mouthwash and Oral Nitrate in Adults With Pulmonary Hypertension,A Randomized Trial of Chlorhexidine Mouthwash and Oral Nitrate in Adults With Pulmonary Hypertension,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Pittsburgh,,2.0,,Study was never able to start after the pandemic restrictions lifted,f,,,,t,t,f,,,,,,Data will be made following publication.,Data will be available publicly.,,YES,"After de-identification, all participant data collected during the trial will be made available.",2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,OTHER,,,,,,,2023,0.0
NCT04676867,,2020-12-17,2022-08-31,,2022-11-10,2020-12-18,2020-12-21,ACTUAL,2022-11-10,2022-12-07,ACTUAL,,,,2022-11-10,2022-12-07,ACTUAL,2021-01-11,ACTUAL,2021-01-11,2021-06,2021-06-30,2021-05-17,ACTUAL,2021-05-17,2021-05-17,ACTUAL,2021-05-17,,INTERVENTIONAL,,"Of the 225 randomized subjects, a total of 208 subjects received at least one dose of study medication, for which baseline data are presented here. The overall number of baseline participants in each arm reflects the number of subjects who took at least one dose of study medication in each arm, not the total number randomized in each arm.",Effect of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19,"A Double-blind, Placebo-controlled, Phase 2a Proof-of-concept Trial of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19",COMPLETED,,PHASE2,227.0,ACTUAL,DalCor Pharmaceuticals,"Small sample size, remote study, and patients were self-sampling for the polymerase chain reaction (PCR) testing albeit under supervision.",4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,INDUSTRY,,,,,,,2021,1.0
NCT04098406,,2019-09-19,2024-02-08,,2024-06-10,2019-09-19,2019-09-23,ACTUAL,2024-06-10,2024-07-03,ACTUAL,,,,2024-06-10,2024-07-03,ACTUAL,2019-12-19,ACTUAL,2019-12-19,2024-06,2024-06-30,2021-07-13,ACTUAL,2021-07-13,2021-07-13,ACTUAL,2021-07-13,,INTERVENTIONAL,RESCUE-ALS,,Therapeutic Nanocatalysis to Slow Disease Progression of Amyotrophic Lateral Sclerosis (ALS),"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study in Early Symptomatic Amyotrophic Lateral Sclerosis Patients on Stable Background Therapy to Assess Bioenergetic Catalysis With CNM-Au8 to Slow Disease Progression in ALS.",COMPLETED,,PHASE2,45.0,ACTUAL,Clene Nanomedicine,,2.0,,,t,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,INDUSTRY,,NCT04081714,AVAILABLE,,,,2021,1.0
NCT06044805,,2023-07-06,,,2023-09-19,2023-09-17,2023-09-21,ACTUAL,,,,,,,2023-09-19,2023-09-22,ACTUAL,2022-12-19,ACTUAL,2022-12-19,2023-09,2023-09-30,2023-03-15,ACTUAL,2023-03-15,2023-03-13,ACTUAL,2023-03-13,,INTERVENTIONAL,CQ+PQ,,Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax,"Monitoring Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax Based on Clinical, Parasitologic and Hematologic Parameters in Shecha Health Center: Open Label Clinical Trial",COMPLETED,,PHASE4,100.0,ACTUAL,Wollega University,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,OTHER,,,,,,,2023,1.0
NCT03020992,,2017-01-11,2020-12-02,,2021-01-20,2017-01-11,2017-01-13,ESTIMATED,2020-12-02,2020-12-31,ACTUAL,,,,2021-01-20,2021-02-09,ACTUAL,2016-12-21,ACTUAL,2016-12-21,2021-01,2021-01-31,2020-01-23,ACTUAL,2020-01-23,2019-12-04,ACTUAL,2019-12-04,,INTERVENTIONAL,C-VIEW,The Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who had received at least 1 dose of IMP.,A Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis (AU) Flares in Axial Spondyloarthritis Subjects With a Documented History of AU,"Multicenter, Open-Label Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis Flares in Axial Spondyloarthritis Subjects With a History of Anterior Uveitis (C-VIEW)",COMPLETED,,PHASE4,89.0,ACTUAL,UCB Pharma,,1.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,INDUSTRY,,,,,,,2020,1.0
NCT04046887,,2019-08-01,,,2024-01-02,2019-08-02,2019-08-06,ACTUAL,,,,,,,2024-01-02,2024-01-05,ACTUAL,2019-09-11,ACTUAL,2019-09-11,2024-01,2024-01-31,2023-10-04,ACTUAL,2023-10-04,2021-05-10,ACTUAL,2021-05-10,,INTERVENTIONAL,,,Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC),Phase I Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC),TERMINATED,,PHASE1,14.0,ACTUAL,Indiana University,,1.0,,Unable to proceed due to Neulasta difficulties and other complications.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 21:43:36.316889,2024-10-16 21:43:36.316889,OTHER,,,,,,,2023,0.0
NCT02288247,,2014-11-07,2021-09-29,2021-04-29,2024-04-04,2014-11-07,2014-11-11,ESTIMATED,2021-11-17,2021-12-15,ACTUAL,2021-04-29,2021-05-03,ACTUAL,2024-04-04,2024-04-05,ACTUAL,2014-12-01,ACTUAL,2014-12-01,2024-03,2024-03-31,2024-03-13,ACTUAL,2024-03-13,2020-04-30,ACTUAL,2020-04-30,,INTERVENTIONAL,PRESIDE,Safety Analysis Set 1 included all participants who received at least one dose of investigational medicinal product (IMP) in period 1.,A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone,"A Randomized, Double Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients Treated With Docetaxel Plus Prednisolone Who Have Progressed on Enzalutamide Alone",COMPLETED,,PHASE3,688.0,ACTUAL,Astellas Pharma Inc,,2.0,,,f,,,,t,t,f,,,t,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://www.clinicalstudydatarequest.com,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,INDUSTRY,,,,,,,2024,1.0
NCT04985968,,2021-07-22,,,2023-12-21,2021-07-30,2021-08-02,ACTUAL,,,,,,,2023-12-21,2023-12-27,ACTUAL,2021-11-24,ACTUAL,2021-11-24,2023-12,2023-12-31,2023-12-20,ACTUAL,2023-12-20,2023-12-20,ACTUAL,2023-12-20,,INTERVENTIONAL,CONCLUDE,,The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis,A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis,TERMINATED,,PHASE3,171.0,ACTUAL,InDex Pharmaceuticals,,3.0,,Due to futility,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,INDUSTRY,,,,,,,2023,0.0
NCT02874651,,2016-08-01,,,2021-12-25,2016-08-17,2016-08-22,ESTIMATED,,,,,,,2021-12-25,2022-01-11,ACTUAL,2016-10,,2016-10-31,2021-12,2021-12-31,2020-08-27,ACTUAL,2020-08-27,2018-11-29,ACTUAL,2018-11-29,,INTERVENTIONAL,ADVANCE,,ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy,ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy With or Without Chemotherapy,TERMINATED,,PHASE2,25.0,ACTUAL,Sun Yat-sen University,,2.0,,Unacceptable toxicity (nasopharynx necrosis and massive hemorrhage),f,,,,t,,,,,,,,,,,NO,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,OTHER,,,,,,,2020,0.0
NCT03829618,,2019-01-24,2021-09-08,,2021-10-08,2019-02-01,2019-02-04,ACTUAL,2021-10-08,2021-10-12,ACTUAL,,,,2021-10-08,2021-10-12,ACTUAL,2019-04-01,ACTUAL,2019-04-01,2021-09,2021-09-30,2020-08-31,ACTUAL,2020-08-31,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,,,Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound,Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound,TERMINATED,,PHASE3,29.0,ACTUAL,Milton S. Hershey Medical Center,The target enrollment was not reached secondary to the COVID-19 pandemic.,3.0,,COVID lack of cases/recruitment,f,,,,,t,f,,,t,,,,,,NO,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,OTHER,,,,,,,2020,0.0
NCT05953688,,2023-06-29,,,2024-08-27,2023-07-18,2023-07-20,ACTUAL,,,,,,,2024-08-27,2024-08-28,ACTUAL,2023-06-14,ACTUAL,2023-06-14,2024-08,2024-08-31,2024-08-13,ACTUAL,2024-08-13,2024-08-13,ACTUAL,2024-08-13,,INTERVENTIONAL,OPTYK-1,,"POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU","A Proof-of-Concept, Randomized, Double-Masked Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Noninfectious Intermediate, Posterior, or Panuveitis (OPTYK-1)",TERMINATED,,PHASE2,36.0,ACTUAL,Alumis Inc,,2.0,,Terminated based on interim efficacy data that did not meet the Sponsor's criteria.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,INDUSTRY,,,,,,,2024,0.0
NCT04070326,,2019-08-26,2022-04-29,,2022-04-29,2019-08-26,2019-08-28,ACTUAL,2022-04-29,2022-05-26,ACTUAL,,,,2022-04-29,2022-05-26,ACTUAL,2019-08-19,ACTUAL,2019-08-19,2022-04,2022-04-30,2021-10-30,ACTUAL,2021-10-30,2021-10-30,ACTUAL,2021-10-30,,INTERVENTIONAL,SPRING,The Safety Analysis Set consisted of all participants who received any study drug.,A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children,"SPRING STUDY: An Open-Label, Multicenter, Phase 3 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab for Prevention Against Acute Attacks of Hereditary Angioedema (HAE) in Pediatric Subjects 2 to <12 Years of Age",COMPLETED,,PHASE3,21.0,ACTUAL,Takeda,,2.0,,,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,INDUSTRY,,,,,,,2021,1.0
NCT04610801,,2020-10-26,,,2023-10-12,2020-10-26,2020-11-02,ACTUAL,,,,,,,2023-10-12,2023-10-16,ACTUAL,2021-12-08,ACTUAL,2021-12-08,2023-10,2023-10-31,2022-08-08,ACTUAL,2022-08-08,2022-06-08,ACTUAL,2022-06-08,,INTERVENTIONAL,,,Evaluation of the Efficacy of Xylitol Nasal Spray Against SARS-CoV-2,A Randomized Placebo Control Trial to Evaluate the Efficacy of Xylitol Nasal Spray vs. Placebo for Acute COVID-19 Infection,WITHDRAWN,,PHASE3,0.0,ACTUAL,Larkin Community Hospital,,3.0,,Study Period Ended/ Not Completed,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,OTHER,,,,,,,2022,0.0
NCT03318861,,2017-10-13,2020-05-06,,2023-10-17,2017-10-20,2017-10-24,ACTUAL,2020-05-06,2020-05-26,ACTUAL,,,,2023-10-17,2023-10-19,ACTUAL,2017-10-20,ACTUAL,2017-10-20,2023-10,2023-10-31,2022-09-16,ACTUAL,2022-09-16,2018-12-17,ACTUAL,2018-12-17,,INTERVENTIONAL,,The Full Analysis Set included all participants who were enrolled in the study.,Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma,"A Phase 1 Multicenter Study of KITE-585, an Autologous Anti-BCMA CAR T-Cell Therapy, in Subjects With Relapsed/Refractory Multiple Myeloma",TERMINATED,,PHASE1,17.0,ACTUAL,Gilead Sciences,,5.0,,The study was terminated due to lack of efficacy,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,INDUSTRY,,,,,,,2022,0.0
NCT04244084,,2019-12-13,2021-05-24,,2022-04-28,2020-01-27,2020-01-28,ACTUAL,2021-09-08,2021-10-06,ACTUAL,,,,2022-04-28,2022-05-17,ACTUAL,2019-10-08,ACTUAL,2019-10-08,2021-10,2021-10-31,2020-04-09,ACTUAL,2020-04-09,2020-04-09,ACTUAL,2020-04-09,,INTERVENTIONAL,,,Clinical Trial of Efficacy and Safety of ММН-407 in Acute Respiratory Viral Infection,Multicenter Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of MMH-407 in the Treatment of Acute Respiratory Viral Infection,COMPLETED,,PHASE3,240.0,ACTUAL,Materia Medica Holding,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,INDUSTRY,,,,,,,2020,1.0
NCT03541174,,2018-05-17,2022-11-08,,2023-03-16,2018-05-29,2018-05-30,ACTUAL,2023-03-16,2023-03-21,ACTUAL,,,,2023-03-16,2023-03-21,ACTUAL,2018-06-18,ACTUAL,2018-06-18,2023-03,2023-03-31,2022-04-25,ACTUAL,2022-04-25,2021-05-14,ACTUAL,2021-05-14,,INTERVENTIONAL,PRECISION,,A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety,"Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)",COMPLETED,,PHASE3,730.0,ACTUAL,Idorsia Pharmaceuticals Ltd.,,6.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,INDUSTRY,,,,,,,2022,1.0
NCT04606394,,2020-10-19,2023-01-16,,2023-05-04,2020-10-22,2020-10-28,ACTUAL,2023-05-04,2023-05-08,ACTUAL,,,,2023-05-04,2023-05-08,ACTUAL,2020-12-02,ACTUAL,2020-12-02,2020-12,2020-12-31,2021-12-15,ACTUAL,2021-12-15,2021-12-15,ACTUAL,2021-12-15,,INTERVENTIONAL,,,Peak Inspiratory Flow and Dry Powder Inhaler Performance in COPD,Peak Inspiratory Flow (PIF) and Dry Powder Inhaler (DPI) Performance in Chronic Obstructive Pulmonary Disease (COPD),COMPLETED,,PHASE4,30.0,ACTUAL,Pulmonary Research Institute of Southeast Michigan,No primary information was available to derive power calculations to estimate the number of subjects needed to test the study hypothesis,1.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,OTHER,,,,,,,2021,1.0
NCT02991482,,2016-12-09,2021-09-08,,2022-08-23,2016-12-09,2016-12-13,ESTIMATED,2021-12-31,2022-02-07,ACTUAL,,,,2022-08-23,2022-08-24,ACTUAL,2017-09-12,ACTUAL,2017-09-12,2022-08,2022-08-31,2021-11-30,ACTUAL,2021-11-30,2019-02-20,ACTUAL,2019-02-20,,INTERVENTIONAL,PROMISE-meso,,PembROlizuMab Immunotherapy Versus Standard Chemotherapy for Advanced prE-treated Malignant Pleural Mesothelioma,A Multicentre Randomised Phase III Trial Comparing Pembrolizumab Versus Standard Chemotherapy for Advanced Pre-treated Malignant Pleural Mesothelioma,COMPLETED,,PHASE3,144.0,ACTUAL,ETOP IBCSG Partners Foundation,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,NETWORK,,,,,,,2021,1.0
NCT04340193,,2020-04-07,,,2024-01-10,2020-04-07,2020-04-09,ACTUAL,,,,,,,2024-01-10,2024-01-11,ACTUAL,2020-09-15,ACTUAL,2020-09-15,2024-01,2024-01-31,2023-12-12,ACTUAL,2023-12-12,2023-12-12,ACTUAL,2023-12-12,,INTERVENTIONAL,CheckMate 74W,,A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer,"A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination With Trans-arterial ChemoEmbolization (TACE) in Patients With Intermediate-stage Hepatocellular Carcinoma (HCC)",TERMINATED,,PHASE3,26.0,ACTUAL,Bristol-Myers Squibb,,3.0,,Slow accrual,t,,,,t,t,f,,,,,,,,,,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,INDUSTRY,,NCT03126643,APPROVED_FOR_MARKETING,,,,2023,0.0
NCT03330106,,2017-10-31,2022-06-13,,2022-06-13,2017-10-31,2017-11-06,ACTUAL,2022-06-13,2023-03-28,ACTUAL,,,,2022-06-13,2023-03-28,ACTUAL,2017-11-15,ACTUAL,2017-11-15,2022-06,2022-06-30,2021-06-21,ACTUAL,2021-06-21,2019-01-07,ACTUAL,2019-01-07,,INTERVENTIONAL,,Randomized Population included all participants who had a randomization date and had been randomized to a treatment sequence.,A Study to Evaluate the Effects of Pevonedistat on the Corrected QT (QTc) Interval in Participants With Advanced Solid Tumors,"A Randomized, Crossover Phase 1 Study to Evaluate the Effects of Pevonedistat on the QTc Interval in Patients With Advanced Solid Tumors",COMPLETED,,PHASE1,68.0,ACTUAL,Takeda,,3.0,,,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,INDUSTRY,,,,,,,2021,0.0
NCT01453088,,2011-06-30,2023-10-06,,2023-11-06,2011-10-13,2011-10-17,ESTIMATED,2023-11-06,2023-11-28,ACTUAL,,,,2023-11-06,2023-11-28,ACTUAL,2010-06-24,ACTUAL,2010-06-24,2023-11,2023-11-30,2022-05-01,ACTUAL,2022-05-01,2022-05-01,ACTUAL,2022-05-01,,INTERVENTIONAL,,,Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myeloma Age 65 Years or Older,(PRO#11307) Phase III Randomized Study of Autologous Stem Cell Transplantation With High-dose Melphalan Versus High-dose Melphalan and Bortezomib in Patients With Multiple Myeloma 65 Year or Older,TERMINATED,,PHASE2,63.0,ACTUAL,Hackensack Meridian Health,,2.0,,Lack of Accrual,f,,,,t,,,,,,,,,,,,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,OTHER,,,,,,,2022,0.0
NCT05313386,,2021-03-31,,,2022-04-01,2022-04-01,2022-04-06,ACTUAL,,,,,,,2022-04-01,2022-04-06,ACTUAL,2021-02-23,ACTUAL,2021-02-23,2022-04,2022-04-30,2022-02-21,ESTIMATED,2022-02-21,2022-02-21,ESTIMATED,2022-02-21,,INTERVENTIONAL,,,Study of BXCL501 In Agitation Associated With Delirium in ICU Patients,"A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled, Ascending Starting Dose Finding, Safety, and Efficacy Study of BXCL501 in Agitation Associated With Delirium in ICU Patients.",WITHDRAWN,,PHASE2,0.0,ACTUAL,BioXcel Therapeutics Inc,,4.0,,"The study stopped early, before enrolling its first participant",f,,,,f,t,f,,,,,,,,,,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,INDUSTRY,,,,,,,2022,0.0
NCT01870505,,2013-06-03,,,2022-03-01,2013-06-03,2013-06-06,ESTIMATED,,,,,,,2022-03-01,2022-03-02,ACTUAL,2013-05,ACTUAL,2013-05-31,2022-03,2022-03-31,2022-02-28,ACTUAL,2022-02-28,2022-02-28,ACTUAL,2022-02-28,,INTERVENTIONAL,,,BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer,A Phase I Trial of BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer,COMPLETED,,PHASE1,52.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,4.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,OTHER,,,,,,,2022,1.0
NCT05061654,,2021-09-20,,,2023-08-10,2021-09-20,2021-09-29,ACTUAL,,,,,,,2023-08-10,2023-08-14,ACTUAL,2022-08,ESTIMATED,2022-08-31,2021-09,2021-09-30,2024-06,ESTIMATED,2024-06-30,2024-01,ESTIMATED,2024-01-31,,INTERVENTIONAL,CEF-10,,CEFtolozane-Tazobactam for the Empiric Anti-bacterial Treatment of Neutropenic Fever in Hematology Patients,"CEFtolozane-Tazobactam for the Empiric Anti-bacterial Treatment of Neutropenic Fever in Hematology Patients; a Single-arm, Single-center, Open-label Clinical Trial (CEF-10 Study)",WITHDRAWN,,PHASE4,0.0,ACTUAL,Hamad Medical Corporation,,1.0,,Administrative constraints,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,INDUSTRY,,,,,,,2024,0.0
NCT04041674,,2019-07-31,,,2021-10-13,2019-07-31,2019-08-01,ACTUAL,,,,,,,2021-10-13,2021-10-15,ACTUAL,2022-03-01,ESTIMATED,2022-03-01,2021-10,2021-10-31,2023-05-31,ESTIMATED,2023-05-31,2022-09-30,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,"Evaluating the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of GEO-D02 DNA and MVA/HIV62B With and Without B63521^11 gp120 and IHV01 gp120 Env Proteins in Healthy, HIV-uninfected Adult Participants","A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of GEO-D02 DNA and MVA/HIV62B With and Without B63521^11 gp120 and IHV01 gp120 Env Proteins in Healthy, HIV-uninfected Adult Participants *Imatinib Mesylate Per Oral as a Clinical Therapeutic for TB",WITHDRAWN,,PHASE1,0.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,5.0,,Protocol undergoing additional revisions.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,NIH,,,,,,,2023,0.0
NCT03034538,,2017-01-25,,,2021-11-15,2017-01-26,2017-01-27,ESTIMATED,,,,,,,2021-11-15,2021-11-23,ACTUAL,2016-04-08,ACTUAL,2016-04-08,2021-11,2021-11-30,2022-12-31,ESTIMATED,2022-12-31,2022-12-01,ESTIMATED,2022-12-01,,INTERVENTIONAL,,,An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease,An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease,SUSPENDED,,PHASE4,20.0,ESTIMATED,The Cooper Health System,,2.0,,Site staffing,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,OTHER,,,,,,,2022,0.0
NCT04854512,,2021-04-19,,,2023-03-10,2021-04-19,2021-04-22,ACTUAL,,,,,,,2023-03-10,2023-03-14,ACTUAL,2021-05-18,ACTUAL,2021-05-18,2023-03,2023-03-31,2024-06-30,ESTIMATED,2024-06-30,2023-12-01,ESTIMATED,2023-12-01,,INTERVENTIONAL,DREAM-T2D,,Investigational Study of Delayed Release Metformin,"Randomized, Multicenter, Double-blind, Parallel-Group, Placebo & Comparator-Controlled Study to Compare the Glycemic Effects, Safety & Tolerability of Metformin Delayed-Release Tablets in Patients With Type 2 Diabetes Mellitus",SUSPENDED,,PHASE3,675.0,ESTIMATED,Anji Pharma,,3.0,,Strategic company decision - not related to a safety concern,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,INDUSTRY,,,,,,,2024,0.0
NCT04486326,,2020-07-20,,,2022-12-13,2020-07-20,2020-07-24,ACTUAL,,,,,,,2022-12-13,2022-12-15,ACTUAL,2020-08-20,ACTUAL,2020-08-20,2022-12,2022-12-31,2022-09-23,ACTUAL,2022-09-23,2022-09-23,ACTUAL,2022-09-23,,INTERVENTIONAL,,,Crofelemer for Functional Diarrhea,Crofelemer for Functional Diarrhea,TERMINATED,,PHASE4,17.0,ACTUAL,Beth Israel Deaconess Medical Center,,2.0,,low enrollment,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,OTHER,,,,,,,2022,0.0
NCT04115020,,2019-10-02,,,2020-01-07,2019-10-02,2019-10-03,ACTUAL,,,,,,,2020-01-07,2020-01-09,ACTUAL,2020-01,ESTIMATED,2020-01-31,2020-01,2020-01-31,2020-01-07,ACTUAL,2020-01-07,2020-01-07,ACTUAL,2020-01-07,,INTERVENTIONAL,,,Low Dose Naltrexone for Chronic Pain in Osteoarthritis and Inflammatory Arthritis,Low Dose Naltrexone for Chronic Pain in Osteoarthritis and Inflammatory Arthritis,WITHDRAWN,,PHASE2,0.0,ACTUAL,Brigham and Women's Hospital,,2.0,,A pilot study was negative.,f,,,,f,t,f,,,f,,,Protocol will be uploaded when results are reported.,,,YES,"A de-identified, anonymized dataset containing all the primary study data will be created and shared consistent with institutional policies. This dataset will be included as a supplementary file attached to the published manuscript, which in turn will be available through PubMed Central. In the event that the study has not been published, the dataset will be made available by other means within 3 years of study completion. The publicly available dataset will not include any identifiers, e.g. age will be included but not birthdate",2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,OTHER,,,,,,,2020,0.0
NCT04360135,,2020-04-17,,,2022-08-16,2020-04-21,2020-04-24,ACTUAL,,,,,,,2022-08-16,2022-08-18,ACTUAL,2020-05-06,ACTUAL,2020-05-06,2022-08,2022-08-31,2021-03-08,ACTUAL,2021-03-08,2021-03-08,ACTUAL,2021-03-08,,INTERVENTIONAL,,,Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy,Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy: a Randomized Control Trial,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Montefiore Medical Center,,2.0,,The study was closed on 3/8/2021 as per final progress report issued by the IRB on 3/12/2021. No subjects were enrolled in the study following approval. Status changed to Withdrawn (No Participants Enrolled) accordingly.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,OTHER,,,,,,,2021,0.0
NCT03240068,,2017-08-02,,,2024-05-02,2017-08-03,2017-08-04,ACTUAL,,,,,,,2024-05-02,2024-05-03,ACTUAL,2017-09-01,ACTUAL,2017-09-01,2024-05,2024-05-31,2020-03-09,ACTUAL,2020-03-09,2020-03-09,ACTUAL,2020-03-09,,INTERVENTIONAL,,,Angiotensin-(1-7) in Peripheral Arterial Disease,Protective Effects of Angiotensin-(1-7) in Peripheral Arterial Disease,TERMINATED,,EARLY_PHASE1,6.0,ACTUAL,Milton S. Hershey Medical Center,,2.0,,Study funding ended prior to completion.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,OTHER,,,,,,,2020,0.0
NCT03143985,,2017-05-04,,,2024-05-23,2017-05-04,2017-05-08,ACTUAL,,,,,,,2024-05-23,2024-05-24,ACTUAL,2017-07-21,ACTUAL,2017-07-21,2024-05,2024-05-31,2022-09-01,ACTUAL,2022-09-01,2022-02-27,ACTUAL,2022-02-27,,INTERVENTIONAL,,,Vactosertib in Combination w/ Pomalidomide in Relapsed or Relapsed and Refractory Multiple Myeloma,A Phase 1b Trial of Vactosertib in Combination With Pomalidomide (POM) in Relapsed or Relapsed and Refractory Multiple Myeloma (RRMM),COMPLETED,,PHASE1,18.0,ACTUAL,Case Comprehensive Cancer Center,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,OTHER,,,,,,,2022,1.0
NCT04336748,,2020-04-04,,,2022-04-04,2020-04-04,2020-04-07,ACTUAL,,,,,,,2022-04-04,2022-04-12,ACTUAL,2020-04,ESTIMATED,2020-04-30,2022-04,2022-04-30,2020-08,ESTIMATED,2020-08-31,2020-07,ESTIMATED,2020-07-31,,INTERVENTIONAL,,,HCQ for Primary Prophylaxis Against COVID19 in Health-care Workers,"Low-dose Hydroxychloroquine for Primary Prophylaxis Against SARS-CoV-2 in Health-care Workers - a Randomized, Double-blind, Controlled Trial",WITHDRAWN,,PHASE3,0.0,ACTUAL,Medical University of Vienna,,2.0,,Not feasible,f,,,,,f,f,,,,,,,,,,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,OTHER,,,,,,,2020,0.0
NCT04533399,,2020-08-28,,,2022-02-14,2020-08-28,2020-08-31,ACTUAL,,,,,,,2022-02-14,2022-02-17,ACTUAL,2020-08-17,ACTUAL,2020-08-17,2022-02,2022-02-28,2022-01-19,ACTUAL,2022-01-19,2021-12-07,ACTUAL,2021-12-07,,INTERVENTIONAL,,,A Study Looking at the Effectiveness and Safety of a COVID-19 Vaccine in South African Adults,"A Phase 2A/B, Randomized, Observer-blinded, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in South African Adult Subjects Living Without HIV; and Safety and Immunogenicity in Adults Living With HIV",COMPLETED,,PHASE2,4422.0,ACTUAL,Novavax,,4.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,INDUSTRY,,,,,,,2022,1.0
NCT03920059,,2019-04-01,,,2021-01-27,2019-04-17,2019-04-18,ACTUAL,,,,,,,2021-01-27,2021-02-01,ACTUAL,2019-08-20,ACTUAL,2019-08-20,2021-01,2021-01-31,2020-01-30,ACTUAL,2020-01-30,2020-01-30,ACTUAL,2020-01-30,,INTERVENTIONAL,,,Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis,A Randomized Open-label Study of Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis,TERMINATED,,PHASE4,2.0,ACTUAL,Chulalongkorn University,,2.0,,Slow recruitment rate,f,,,,,f,f,,,,,,,,,,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,OTHER,,,,,,,2020,0.0
NCT01966471,,2013-10-17,2020-11-17,,2022-06-13,2013-10-17,2013-10-21,ESTIMATED,2020-12-18,2021-01-12,ACTUAL,,,,2022-06-13,2022-06-14,ACTUAL,2014-01-31,ACTUAL,2014-01-31,2022-06,2022-06-30,2021-06-04,ACTUAL,2021-06-04,2019-11-27,ACTUAL,2019-11-27,,INTERVENTIONAL,,Baseline Measures are based on the Intent-to-Treat (ITT) population.,A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer,"A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer",COMPLETED,,PHASE3,1846.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,INDUSTRY,,,,,,,2021,1.0
NCT03907072,,2019-04-05,2021-04-05,,2021-04-29,2019-04-05,2019-04-08,ACTUAL,2021-04-29,2021-05-20,ACTUAL,,,,2021-04-29,2021-05-20,ACTUAL,2019-09-04,ACTUAL,2019-09-04,2021-04,2021-04-30,2020-01-09,ACTUAL,2020-01-09,2019-12-16,ACTUAL,2019-12-16,,INTERVENTIONAL,DYSTANCE 51,,Efficacy and Safety Study of WVE-210201 (Suvodirsen) With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy,"A Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy (DYSTANCE 51)",TERMINATED,,PHASE2/PHASE3,6.0,ACTUAL,Wave Life Sciences Ltd.,,3.0,,Lack of efficacy,f,,,,t,t,f,,,,,,,,,,,2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,INDUSTRY,,,,,,,2020,0.0
NCT04371640,,2020-04-28,,,2021-12-02,2020-04-28,2020-05-01,ACTUAL,,,,,,,2021-12-02,2021-12-03,ACTUAL,2020-07-06,ACTUAL,2020-07-06,2021-12,2021-12-31,2021-07-30,ACTUAL,2021-07-30,2021-07-30,ACTUAL,2021-07-30,,INTERVENTIONAL,SirCO-1,,Sirolimus in COVID-19 Phase 1,"A Randomized, Double-Blinded, Placebo-Controlled Trial Evaluating the Virological Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sirolimus Adjuvant Therapy in Patients With Coronavirus Disease (COVID-19)",WITHDRAWN,,PHASE1,0.0,ACTUAL,Thomas Jefferson University,,2.0,,Study population not regularly admitted to hospital and approaches have shifted away from repurposing old drugs.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,OTHER,,,,,,,2021,0.0
NCT05084560,,2021-10-05,,,2023-09-19,2021-10-19,2021-10-20,ACTUAL,,,,,,,2023-09-19,2023-09-21,ACTUAL,2021-12-10,ACTUAL,2021-12-10,2023-09,2023-09-30,2023-05-22,ACTUAL,2023-05-22,2023-05-22,ACTUAL,2023-05-22,,INTERVENTIONAL,AWOL,,"Development of AWZ1066S, a Small Molecule Anti-Wolbachia Candidate Macrofilaricide Drug","Development of AWZ1066S, a Small Molecule Anti-Wolbachia Candidate Macrofilaricide Drug",TERMINATED,,PHASE1,30.0,ACTUAL,Liverpool School of Tropical Medicine,,2.0,,Safety issues,f,,,,t,f,f,,,,,,,,,NO,Commercial sensitivity,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,OTHER,,,,,,,2023,0.0
NCT04707625,,2021-01-11,,,2024-04-25,2021-01-11,2021-01-13,ACTUAL,,,,,,,2024-04-25,2024-04-29,ACTUAL,2021-10-06,ACTUAL,2021-10-06,2023-12,2023-12-31,2023-12-18,ACTUAL,2023-12-18,2023-12-18,ACTUAL,2023-12-18,,INTERVENTIONAL,,,Vascular Endothelial Growth Factor (VEGF) Levels in Retinal Vein Occlusion (RVO) During Anti-VEGF Treatment,Correlation of Vascular Endothelial Growth Factor Levels in Anterior Chamber Fluid to Disease State in Patients With Retinal Vein Occlusion Receiving Standard of Care Treatment,TERMINATED,,PHASE4,17.0,ACTUAL,Wake Forest University Health Sciences,,1.0,,IRB stopped study due to safety concerns. No further data collection and what has been collected is not appropriate for analysis.,f,,,,f,t,f,,,t,,,,,,NO,There is no plan to share IPD at this time.,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,OTHER,,,,,,,2023,0.0
NCT04614051,,2020-10-22,,,2022-12-29,2020-10-28,2020-11-03,ACTUAL,,,,,,,2022-12-29,2023-01-03,ACTUAL,2021-03-30,ACTUAL,2021-03-30,2022-12,2022-12-31,2022-05-10,ACTUAL,2022-05-10,2022-05-10,ACTUAL,2022-05-10,,INTERVENTIONAL,,,Safety Evaluation of Autologous Dendritic Cell Anticancer Immune Cell Therapy (Cellgram-DC),"An Open Label, Single-center, Phase 1 Study to Evaluate the Safety of Cancer Immunotherapy With Autologous Dendritic Cells in Patients With Advanced or Recurrent Epithelial Ovarian Cancer",TERMINATED,,PHASE1,2.0,ACTUAL,"Pharmicell Co., Ltd.",,1.0,,Difficult recruitment,f,,,,f,f,f,,,,,,,,,,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,INDUSTRY,,,,,,,2022,0.0
NCT04173780,,2019-11-20,,,2024-08-28,2019-11-20,2019-11-22,ACTUAL,,,,,,,2024-08-28,2024-08-29,ACTUAL,2020-02-12,ACTUAL,2020-02-12,2024-08,2024-08-31,2024-06-03,ACTUAL,2024-06-03,2024-05-15,ACTUAL,2024-05-15,,INTERVENTIONAL,Myopie-STOP,,Topical 0.01% Atropine for the Control of Fast Progressing Myopia,Topical 0.01% Atropine for the Control of Fast Progressing Myopia,TERMINATED,,PHASE2/PHASE3,60.0,ACTUAL,"University Hospital, Strasbourg, France",,2.0,,recruitment difficulties,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,OTHER,,,,,,,2024,0.0
NCT03687333,,2018-09-24,,,2022-04-05,2018-09-25,2018-09-27,ACTUAL,,,,,,,2022-04-05,2022-04-13,ACTUAL,2018-12-04,ACTUAL,2018-12-04,2022-04,2022-04-30,2020-12-30,ACTUAL,2020-12-30,2020-12-30,ACTUAL,2020-12-30,,INTERVENTIONAL,APOLLO-IOPD,,Evaluate Efficacy and Safety in Chinese Patients With Infantile-Onset Pompe Disease With One Year Alglucosidase Alfa Treatment,"A Single Arm, Prospective, Open-label, Multi-center Study to Evaluate Efficacy and Safety in Chinese Patients With Infantile-Onset Pompe Disease With One Year Alglucosidase Alfa Treatment",COMPLETED,,PHASE4,10.0,ACTUAL,Sanofi,,1.0,,,f,,,,f,f,f,,,f,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,INDUSTRY,,,,,,,2020,1.0
NCT03824704,,2019-01-21,2021-05-19,,2023-06-07,2019-01-30,2019-01-31,ACTUAL,2021-05-19,2021-06-15,ACTUAL,,,,2023-06-07,2023-06-12,ACTUAL,2019-08-23,ACTUAL,2019-08-23,2023-06,2023-06-30,2020-08-24,ACTUAL,2020-08-24,2020-08-24,ACTUAL,2020-08-24,,INTERVENTIONAL,,,A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES),"A Phase 2, Open-label Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)",TERMINATED,,PHASE2,1.0,ACTUAL,pharmaand GmbH,The Sponsor made a business decision to discontinue the study due to low accrual.,1.0,,Sponsor made a business decision to discontinue the study due to low accrual.,,,,,t,t,f,,,,,,,,,,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,INDUSTRY,,,,,,,2020,0.0
NCT02964507,,2016-11-12,2021-09-27,,2024-08-06,2016-11-12,2016-11-16,ESTIMATED,2021-11-18,2022-01-27,ACTUAL,,,,2024-08-06,2024-08-29,ACTUAL,2019-09-26,ACTUAL,2019-09-26,2024-08,2024-08-31,2021-07-19,ACTUAL,2021-07-19,2020-09-29,ACTUAL,2020-09-29,,INTERVENTIONAL,,"The interim analysis failed to demonstrate clinically meaningful activity, hence Phase II was not initiated.",Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Participants With Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced or Metastatic Breast Cancer,"A Phase I/II Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Combination With Fulvestrant in Subjects With Hormone Receptor-positive/HER2-negative (HR+/HER2-) Advanced or Metastatic Breast Cancer",TERMINATED,,PHASE1,124.0,ACTUAL,GlaxoSmithKline,,3.0,,This study has been terminated due to meeting protocol defined futility.,f,,,,f,t,f,,,,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf,YES,"GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf",2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,INDUSTRY,,,,,,,2021,0.0
NCT02257567,,2014-10-02,2022-10-18,,2022-10-18,2014-10-03,2014-10-06,ESTIMATED,2022-10-18,2022-11-14,ACTUAL,,,,2022-10-18,2022-11-14,ACTUAL,2014-10-15,ACTUAL,2014-10-15,2022-10,2022-10-31,2021-10-21,ACTUAL,2021-10-21,2021-10-21,ACTUAL,2021-10-21,,INTERVENTIONAL,,"Intent-to-treat (ITT) population included all participants who were randomized, whether or not the participants received the assigned treatment.",A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma,"A Phase IB/II Study Evaluating The Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin in Combination With Rituximab (R) or Obinutuzumab (G) Plus Bendamustine (B) in Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma",COMPLETED,,PHASE1/PHASE2,331.0,ACTUAL,Hoffmann-La Roche,,12.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,INDUSTRY,,,,,,,2021,1.0
NCT03303469,,2017-09-13,2021-01-27,,2021-02-15,2017-10-02,2017-10-06,ACTUAL,2021-02-15,2021-02-21,ACTUAL,,,,2021-02-15,2021-02-21,ACTUAL,2017-10-30,ACTUAL,2017-10-30,2021-02,2021-02-28,2021-01-06,ACTUAL,2021-01-06,2021-01-06,ACTUAL,2021-01-06,,INTERVENTIONAL,,,Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging,Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: [18F]Fluoromisonidazole (FMISO) Imaging,TERMINATED,,PHASE2,3.0,ACTUAL,University of Alabama at Birmingham,,1.0,,study was terminated due to poor enrollment,f,,,,,t,f,,,,,,,,,,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,OTHER,,,,,,,2021,0.0
NCT03846102,,2019-02-07,,,2021-05-03,2019-02-18,2019-02-19,ACTUAL,,,,,,,2021-05-03,2021-05-06,ACTUAL,2019-01-28,ACTUAL,2019-01-28,2021-05,2021-05-31,2020-02-18,ACTUAL,2020-02-18,2020-02-18,ACTUAL,2020-02-18,,INTERVENTIONAL,MORFICUS,,MORphine Use in the Fascia Iliaca Compartment Block With UltraSound,MORphine Use in the Fascia Iliaca Compartment Block With UltraSound,TERMINATED,,PHASE4,55.0,ACTUAL,Zuyderland Medisch Centrum,,2.0,,COVID-19 crisis.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,OTHER,,,,,,,2020,0.0
NCT05711862,,2023-01-13,,,2024-05-02,2023-02-02,2023-02-03,ACTUAL,,,,,,,2024-05-02,2024-05-06,ACTUAL,2023-03-09,ACTUAL,2023-03-09,2024-05,2024-05-31,2024-03-28,ACTUAL,2024-03-28,2024-03-28,ACTUAL,2024-03-28,,INTERVENTIONAL,,,"The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder","The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder",TERMINATED,,PHASE2,7.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,Lack of enrollment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,OTHER,,,,,,,2024,0.0
NCT04859582,,2021-04-23,,,2021-12-15,2021-04-23,2021-04-26,ACTUAL,,,,,,,2021-12-15,2021-12-16,ACTUAL,2018-11-08,ACTUAL,2018-11-08,2021-12,2021-12-31,2024-11-29,ESTIMATED,2024-11-29,2024-11-29,ESTIMATED,2024-11-29,,INTERVENTIONAL,,,Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)-China Extension,"A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)",WITHDRAWN,,PHASE3,0.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,Withdrawn due to protocol amendment,f,,,,t,t,f,,,t,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,INDUSTRY,,,,,,,2024,0.0
NCT03973879,,2019-05-31,,,2020-02-07,2019-06-03,2019-06-04,ACTUAL,,,,,,,2020-02-07,2020-02-11,ACTUAL,2020-02,ESTIMATED,2020-02-29,2020-02,2020-02-29,2024-01,ESTIMATED,2024-01-31,2024-01,ESTIMATED,2024-01-31,,INTERVENTIONAL,,,Combination of PVSRIPO and Atezolizumab for Adults With Recurrent Malignant Glioma,A Phase 1b/2 Trial of PVSRIPO in Combination With Atezolizumab in Recurrent WHO Grade IV Malignant Glioma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Duke University,,1.0,,Re-submission Planned,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,OTHER,,,,,,,2024,0.0
NCT05209308,,2022-01-12,,,2023-03-14,2022-01-12,2022-01-26,ACTUAL,,,,,,,2023-03-14,2023-03-16,ACTUAL,2022-11-22,ACTUAL,2022-11-22,2023-03,2023-03-31,2023-03-15,ACTUAL,2023-03-15,2023-03-15,ACTUAL,2023-03-15,,INTERVENTIONAL,CORAL,,Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL,"A Phase 2 Single-Arm, Open-Label Study to Assess the Safety and Efficacy of Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia - The CORAL Study",WITHDRAWN,,PHASE2,0.0,ACTUAL,"MEI Pharma, Inc.",,2.0,,Discontinuation of zandelisib development,f,,,,f,t,f,,,,,,,,,,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,INDUSTRY,,,,,,,2023,0.0
NCT05249829,,2022-02-19,2024-07-11,,2024-07-11,2022-02-19,2022-02-22,ACTUAL,2024-07-11,2024-08-09,ACTUAL,,,,2024-07-11,2024-08-09,ACTUAL,2022-02-16,ACTUAL,2022-02-16,2024-07,2024-07-31,2023-06-23,ACTUAL,2023-06-23,2023-06-23,ACTUAL,2023-06-23,,INTERVENTIONAL,,The Safety Set included all randomized participants who received the study vaccine. Participants were included in the study vaccine arm that they actually received.,A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19,"A Phase 2/3, Randomized, Observer-blind, Active-controlled, Multicenter Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 (Prototype) Booster Vaccine",COMPLETED,,PHASE2/PHASE3,3548.0,ACTUAL,"ModernaTX, Inc.",,4.0,,,f,,,,,t,f,,,t,,,,,,NO,,2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,INDUSTRY,,,,,,,2023,1.0
NCT05206656,,2021-12-16,,,2022-11-21,2022-01-11,2022-01-25,ACTUAL,,,,,,,2022-11-21,2022-11-23,ACTUAL,2020-10-09,ACTUAL,2020-10-09,2022-11,2022-11-30,2022-07-20,ACTUAL,2022-07-20,2022-04-30,ACTUAL,2022-04-30,,INTERVENTIONAL,,,Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer,"Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer Patients: An Open-Labeled, Single-center, Prospective Study",COMPLETED,,PHASE2,80.0,ACTUAL,Hunan Cancer Hospital,,2.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,OTHER,,,,,,,2022,1.0
NCT03515551,,2018-04-05,2021-12-08,,2022-03-09,2018-05-02,2018-05-03,ACTUAL,2022-03-09,2022-03-11,ACTUAL,,,,2022-03-09,2022-03-11,ACTUAL,2018-06-15,ACTUAL,2018-06-15,2022-03,2022-03-31,2021-05-10,ACTUAL,2021-05-10,2021-05-10,ACTUAL,2021-05-10,,INTERVENTIONAL,,The Full Analysis Set includes all participants assigned to treatment who receive at least 1 full or partial dose of study drug; one participant that sequentially enrolled in two cohorts (10 mcg and 30-100 mcg) is represented in the 30-100 mcg cohort.,Safety and Efficacy of IMCnyeso in Advanced NY-ESO-1 and/or LAGE-1A Positive Cancers,"A Phase I/II Study of IMCnyeso, HLA- A*0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, in HLA-A*0201 Positive Patients With Advanced NY-ESO-1 and/or LAGE - 1A Positive Cancer",TERMINATED,,PHASE1/PHASE2,29.0,ACTUAL,Immunocore Ltd,,2.0,,Strategic decision to stop development and not based on any safety concerns,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,INDUSTRY,,,,,,,2021,0.0
NCT04143165,,2019-10-26,,,2020-04-03,2019-10-28,2019-10-29,ACTUAL,,,,,,,2020-04-03,2020-04-07,ACTUAL,2019-10-12,ACTUAL,2019-10-12,2020-04,2020-04-30,2020-02-12,ACTUAL,2020-02-12,2020-01-12,ACTUAL,2020-01-12,,INTERVENTIONAL,,,Ultrasound Guided Epidural Block in Axial SPA,Ultrasound Guided Epidural Block in Axial SPA Patient With Limited Spine Mobility: a Prospective Pilot Randomized Controlled Trial,COMPLETED,,PHASE4,52.0,ACTUAL,Sohag University,,2.0,,,f,,,,,f,f,,,,,,,,,NO,The consent form does not include this item,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,OTHER,,,,,,,2020,1.0
NCT03240523,,2017-07-21,,,2023-06-06,2017-08-02,2017-08-07,ACTUAL,,,,,,,2023-06-06,2023-06-07,ACTUAL,2017-07-31,ACTUAL,2017-07-31,2023-06,2023-06-30,2021-10-25,ACTUAL,2021-10-25,2020-06-28,ACTUAL,2020-06-28,,INTERVENTIONAL,ASTEROID 5,,Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids,"A Randomized, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",TERMINATED,,PHASE3,766.0,ACTUAL,Bayer,,3.0,,"Due to a change in the development program, the study was closed prematurely.",f,,,,f,f,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,INDUSTRY,,,,,,,2021,0.0
NCT03773172,,2018-12-10,,,2020-12-10,2018-12-11,2018-12-12,ACTUAL,,,,,,,2020-12-10,2020-12-11,ACTUAL,2019-01-31,ACTUAL,2019-01-31,2020-12,2020-12-31,2020-05-20,ACTUAL,2020-05-20,2020-05-20,ACTUAL,2020-05-20,,INTERVENTIONAL,,,Study to Evaluate the Effects of MEDI6012 on Apolipoprotein B100 Metabolism,Study to Evaluate the Effects of Two Doses Over 48 Hours of MEDI6012 on Apolipoprotein B100 Metabolism in Subjects With Stable Atherosclerotic Cardiovascular Disease,TERMINATED,,PHASE2,7.0,ACTUAL,Columbia University,,2.0,,Early termination due to COVID-19,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,OTHER,,,,,,,2020,0.0
NCT04419389,,2020-06-01,,,2023-08-04,2020-06-03,2020-06-05,ACTUAL,,,,,,,2023-08-04,2023-08-07,ACTUAL,2021-03-02,ACTUAL,2021-03-02,2023-08,2023-08-31,2021-08-24,ACTUAL,2021-08-24,2021-08-23,ACTUAL,2021-08-23,,INTERVENTIONAL,R/R,,APR-246 in Combination With Acalabrutinib or Venetoclax Based Therapy in Subjects With R/R Non Hodgkin Lymphomas (NHL),Phase 1 and Dose Expansion Study of APR-246 in Combination With Acalabrutinib or Venetoclax-based Therapy in Subjects With R/R NHL Including Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL),TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,Aprea Therapeutics,,4.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,INDUSTRY,,,,,,,2021,0.0
NCT04117958,,2019-10-04,,,2023-06-19,2019-10-04,2019-10-07,ACTUAL,,,,,,,2023-06-19,2023-06-22,ACTUAL,2020-01-20,ACTUAL,2020-01-20,2023-06,2023-06-30,2023-06-01,ACTUAL,2023-06-01,2023-06-01,ACTUAL,2023-06-01,,INTERVENTIONAL,,,"Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers","A Global Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of the Half-life Extended Bispecific T-cell Engager AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers",TERMINATED,,PHASE1,58.0,ACTUAL,Amgen,,2.0,,Business decision,,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,INDUSTRY,,,,,,,2023,0.0
NCT04536922,,2020-09-02,,,2021-01-29,2020-09-02,2020-09-03,ACTUAL,,,,,,,2021-01-29,2021-02-01,ACTUAL,2021-01-27,ACTUAL,2021-01-27,2021-01,2021-01-31,2021-01-27,ACTUAL,2021-01-27,2021-01-27,ACTUAL,2021-01-27,,INTERVENTIONAL,,,Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated or Viral Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab,Single Patient Protocol: A Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated or Viral Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab,WITHDRAWN,,PHASE2,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,Subject no longer able to participate in this single pt study.,f,,,,,t,f,,,,,,,,,,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,NIH,,,,,,,2021,0.0
NCT02362230,,2015-02-08,,,2021-01-26,2015-02-08,2015-02-12,ESTIMATED,,,,,,,2021-01-26,2021-01-29,ACTUAL,2015-01,ACTUAL,2015-01-31,2021-01,2021-01-31,2020-12-15,ACTUAL,2020-12-15,2020-12-15,ACTUAL,2020-12-15,,INTERVENTIONAL,,,Evaluation of Icotinib in Metastatic Triple-negative Breast Cancer After Second-line Therapy,Sun Yat-sen University Cancer Center,TERMINATED,,PHASE2,26.0,ACTUAL,Sun Yat-sen University,,1.0,,Difficulty accruing subjects the study accrual was closed,f,,,,t,,,,,,,,,,,NO,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,OTHER,,,,,,,2020,0.0
NCT03056638,,2017-02-15,2024-08-02,,2024-08-02,2017-02-16,2017-02-17,ACTUAL,2024-08-02,2024-08-28,ACTUAL,,,,2024-08-02,2024-08-28,ACTUAL,2017-03-28,ACTUAL,2017-03-28,2024-08,2024-08-31,2023-08-16,ACTUAL,2023-08-16,2023-08-16,ACTUAL,2023-08-16,,INTERVENTIONAL,,,Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer,Phase III Randomized Trial Comparing Short Course Androgen Deprivation Therapy and Ultra-Hypofractionated SBRT Versus SBRT Alone For Intermediate Prostate Cancer,TERMINATED,,PHASE3,56.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,2.0,,Due to low accrual,f,,,,,t,f,,,,,,,,,,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,OTHER,,,,,,,2023,0.0
NCT03412734,,2018-01-22,2020-10-26,,2021-01-06,2018-01-22,2018-01-26,ACTUAL,2020-10-26,2020-11-18,ACTUAL,,,,2021-01-06,2021-01-11,ACTUAL,2018-05-18,ACTUAL,2018-05-18,2021-01,2021-01-31,2020-01-29,ACTUAL,2020-01-29,2019-08-26,ACTUAL,2019-08-26,,INTERVENTIONAL,,,Vaginal Preparation Prior to Hysterectomy,Is Chlorhexidine Vaginal Preparation Prior to Hysterectomy Superior to Iodine in Reducing Bacterial Count; a Randomized Controlled Trial,TERMINATED,,PHASE4,94.0,ACTUAL,TriHealth Inc.,,2.0,,The institutional review board recommended the study stop enrollment prior to achieving its initial sample size for patient safety.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,OTHER,,,,,,,2020,0.0
NCT05172349,,2021-12-07,,,2022-08-02,2021-12-27,2021-12-29,ACTUAL,,,,,,,2022-08-02,2022-08-05,ACTUAL,2022-04,ESTIMATED,2022-04-30,2022-08,2022-08-31,2022-09,ESTIMATED,2022-09-30,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Trophic Ulcers,"Pilote Study of the Use of a Double Amniotic Membrane Inserted in a Ring of Umbilical Vessels With Wharton's Jelly, Tissues Treated by the AMTRIX Process, in the Treatment of Trophic Ulcers",WITHDRAWN,,PHASE2,0.0,ACTUAL,TBF Genie Tissulaire,,1.0,,Change in sponsor's strategy,f,,,,f,f,f,,,,,,,,,,,2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,INDUSTRY,,,,,,,2022,0.0
NCT03818399,,2019-01-04,2022-02-24,,2022-04-08,2019-01-24,2019-01-28,ACTUAL,2022-04-08,2022-05-05,ACTUAL,,,,2022-04-08,2022-05-05,ACTUAL,2019-01-04,ACTUAL,2019-01-04,2022-04,2022-04-30,2021-02-24,ACTUAL,2021-02-24,2021-02-24,ACTUAL,2021-02-24,,INTERVENTIONAL,VOTIVE,,Virginia Opioid Overdose Treatment InitiatVE,Virginia Opioid Overdose Treatment InitiatVE,TERMINATED,,PHASE3,19.0,ACTUAL,Virginia Commonwealth University,,1.0,,"Due to a financial business decision by the company supporting the research study (Indivior). The decision was not due to adverse events, safety reasons, or scientific reasons, but was a business decision.",,,,,,t,f,,,,,,,,,,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,OTHER,,,,,,,2021,0.0
NCT04909892,,2021-05-29,,,2021-09-14,2021-05-29,2021-06-02,ACTUAL,,,,,,,2021-09-14,2021-09-16,ACTUAL,2021-08,ESTIMATED,2021-08-31,2021-09,2021-09-30,2022-01,ESTIMATED,2022-01-31,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,,,Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 Long Haul Pulmonary Compromise,A Phase 2a Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 Long Haul Pulmonary Compromise,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,2.0,,Replaced by a different protocol.,f,,,,,t,f,,,,,,,,,,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,INDUSTRY,,,,,,,2022,0.0
NCT04333420,,2020-04-01,2022-12-22,,2023-05-25,2020-04-01,2020-04-03,ACTUAL,2023-05-25,2023-06-05,ACTUAL,,,,2023-05-25,2023-06-05,ACTUAL,2020-03-31,ACTUAL,2020-03-31,2023-03,2023-03-31,2021-12-01,ACTUAL,2021-12-01,2021-10-31,ACTUAL,2021-10-31,,INTERVENTIONAL,PANAMO,Full Analysis Set (excluding one subject who was randomized in error to group Phase III: IFX-1 + SOC),"Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia","A Pragmatic Adaptive Randomized, Controlled Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia",COMPLETED,,PHASE2/PHASE3,399.0,ACTUAL,InflaRx GmbH,,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,INDUSTRY,,,,,,,2021,1.0
NCT03596073,,2018-07-10,,,2024-03-15,2018-07-19,2018-07-23,ACTUAL,,,,,,,2024-03-15,2024-03-18,ACTUAL,2018-11-07,ACTUAL,2018-11-07,2024-03,2024-03-31,2020-08-31,ACTUAL,2020-08-31,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,,,Topical Calcipotriene Treatment for Breast Cancer Immunoprevention,A Pilot Trial of Topical Calcipotriene Treatment for Breast Cancer Immunoprevention,TERMINATED,,PHASE1,43.0,ACTUAL,Massachusetts General Hospital,,2.0,,Interim analysis did not show the required cytokine induction by topical calcipotriene to justify continuation of the trial,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,OTHER,,,,,,,2020,0.0
NCT04143958,,2019-10-28,,,2023-04-05,2019-10-28,2019-10-30,ACTUAL,,,,,,,2023-04-05,2023-04-07,ACTUAL,2020-09,ESTIMATED,2020-09-30,2023-04,2023-04-30,2023-11,ESTIMATED,2023-11-30,2023-11,ESTIMATED,2023-11-30,,INTERVENTIONAL,BCLEAR1,,To Assess the Glycosphingolipid Clearance and Clinical Effects of Switching to Agalsidase Beta (Fabrazyme) Versus Continuing on Agalsidase Alfa (Replagal) in Male Patients With Classic Fabry Disease,"A Randomized, Open-label, Active Comparator, 2-arm, Prospective Study to Assess the Glycosphingolipid Clearance and Clinical Effects of Switching to Agalsidase Beta (Fabrazyme) Versus Continuing on Agalsidase Alfa (Replagal) in Male Patients With Classic Fabry Disease",WITHDRAWN,,PHASE4,0.0,ACTUAL,Sanofi,,2.0,,The Sponsor terminated the study due to recruitment infeasibility without having enrolled any patient.,f,,,,,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,INDUSTRY,,,,,,,2023,0.0
NCT04591028,,2020-10-15,,,2023-07-17,2020-10-15,2020-10-19,ACTUAL,,,,,,,2023-07-17,2023-07-19,ACTUAL,2022-01,ESTIMATED,2022-01-31,2023-07,2023-07-31,2022-08-10,ESTIMATED,2022-08-10,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,,,A Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients,Indocyanine Green Lymphangiography as a Tool for Improving Lymphadenectomy in Gastric Cancer,WITHDRAWN,,PHASE4,0.0,ACTUAL,Mayo Clinic,,1.0,,Lack of funding.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,OTHER,,,,,,,2022,0.0
NCT03813238,,2019-01-22,2023-06-30,,2023-08-14,2019-01-22,2019-01-23,ACTUAL,2023-08-14,2023-09-08,ACTUAL,,,,2023-08-14,2023-09-08,ACTUAL,2019-08-06,ACTUAL,2019-08-06,2023-08,2023-08-31,2022-07-21,ACTUAL,2022-07-21,2022-07-05,ACTUAL,2022-07-05,,INTERVENTIONAL,RECLAIM-DCP,The intent-to-treat (ITT) analysis set included all randomized participants.,A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents,"A Randomized, Double-Blind, Placebo-Controlled Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents",COMPLETED,,PHASE3,63.0,ACTUAL,"Teva Branded Pharmaceutical Products R&D, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.",2024-10-15 14:25:03.592763,2024-10-15 14:25:03.592763,INDUSTRY,,,,,,,2022,1.0
NCT02842580,,2016-07-13,2022-08-19,,2024-07-05,2016-07-20,2016-07-25,ESTIMATED,2024-07-05,2024-07-10,ACTUAL,,,,2024-07-05,2024-07-10,ACTUAL,2016-09,ACTUAL,2016-09-30,2024-07,2024-07-31,2020-10,ACTUAL,2020-10-31,2020-10,ACTUAL,2020-10-31,,INTERVENTIONAL,HIGH-LIGHT,Baseline population is the ITT population meaning all the patients randomized into the study,De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer,Randomized Phase II Study Assessing the Efficacy and Safety of 2 Therapeutic Strategies Combining Bevacizumab With Chemotherapy: De-escalation Versus Escalation in Patients With Non-pretreated Unresectable Metastatic Colorectal Cancer,TERMINATED,,PHASE2,21.0,ACTUAL,Federation Francophone de Cancerologie Digestive,,2.0,,Inclusion rythm too slow.,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-16 21:49:29.043409,2024-10-16 21:49:29.043409,OTHER,,,,,,,2020,0.0
NCT02525939,,2015-08-13,2022-09-01,,2022-10-09,2015-08-14,2015-08-18,ESTIMATED,2022-10-09,2022-10-12,ACTUAL,,,,2022-10-09,2022-10-12,ACTUAL,2016-04,ACTUAL,2016-04-30,2022-09,2022-09-30,2021-10,ACTUAL,2021-10-31,2021-10,ACTUAL,2021-10-31,,INTERVENTIONAL,dal-GenE,,Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS,"A Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial",COMPLETED,,PHASE3,6147.0,ACTUAL,DalCor Pharmaceuticals,The main limitation of this study is the occurrence of the COVID-19 pandemic during study conduct.,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 00:30:16.466235,2024-10-15 00:30:16.466235,INDUSTRY,,,,,,,2021,1.0
NCT03322540,,2017-10-24,2020-01-06,,2022-01-19,2017-10-24,2017-10-26,ACTUAL,2020-01-06,2020-02-05,ACTUAL,,,,2022-01-19,2022-01-24,ACTUAL,2017-12-15,ACTUAL,2017-12-15,2022-01,2022-01-31,2020-11-09,ACTUAL,2020-11-09,2019-01-10,ACTUAL,2019-01-10,,INTERVENTIONAL,,Intent-to-treat (ITT) population consisted of all randomized participants.,Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05),"A Phase 2, Randomized, Double-Blind Study of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Versus Pembrolizumab Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer Expressing High Levels of PD-L1",COMPLETED,,PHASE2,154.0,ACTUAL,Incyte Corporation,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,INDUSTRY,,,,,,,2020,1.0
NCT01774487,,2013-01-22,2023-05-27,,2024-01-09,2013-01-22,2013-01-24,ESTIMATED,2023-09-19,2023-10-12,ACTUAL,,,,2024-01-09,2024-01-11,ACTUAL,2013-02-04,ACTUAL,2013-02-04,2024-01,2024-01-31,2023-02-20,ACTUAL,2023-02-20,2018-02-07,ACTUAL,2018-02-07,,INTERVENTIONAL,,,Pentoxifylline Therapy in Biliary Atresia,A Phase II Trial of Pentoxifylline in Newly-Diagnosed Biliary Atresia,TERMINATED,,PHASE2,17.0,ACTUAL,Baylor College of Medicine,"Because of early termination, this study did not reach the target number of participants needed to achieve target power and statistically reliable results.",1.0,,"Target enrollment was not reached because the medication, pentoxifylline, has a taste that is not well tolerated by infants. The study team decided to end the study before meeting the enrollment goal because of the medication taste.",f,,,,t,t,f,,,,,,,,,NO,The data for subjects will be shared in aggregate.,2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,OTHER,,,,,,,2023,0.0
NCT02789254,,2016-05-13,,,2023-12-21,2016-05-27,2016-06-02,ESTIMATED,,,,,,,2023-12-21,2023-12-28,ACTUAL,2017-02-07,ACTUAL,2017-02-07,2023-12,2023-12-31,2021-09-27,ACTUAL,2021-09-27,2021-09-27,ACTUAL,2021-09-27,,INTERVENTIONAL,FLYSYN-101,,FLYSYN in MRD Positive AML,"First in Man Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Fc-optimized FLT3 Antibody FLYSYN for the Treatment of Acute Myeloid Leukemia Patients With Minimal Residual Disease",COMPLETED,,PHASE1/PHASE2,31.0,ACTUAL,Synimmune GmbH,,1.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,publication,2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,INDUSTRY,,,,,,,2021,1.0
NCT04740827,,2021-02-02,2023-08-03,,2023-09-19,2021-02-02,2021-02-05,ACTUAL,2023-09-19,2023-09-21,ACTUAL,,,,2023-09-19,2023-09-21,ACTUAL,2021-03-05,ACTUAL,2021-03-05,2023-09,2023-09-30,2022-08-04,ACTUAL,2022-08-04,2022-08-04,ACTUAL,2022-08-04,,INTERVENTIONAL,ELEVATE,Intent-to-Treat (ITT) Population included all randomized participants.,Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.,"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prophylaxis of Migraine in Participants With Episodic Migraine Who Have Previously Failed 2 to 4 Classes of Oral Prophylactic Treatments (ELEVATE)",COMPLETED,,PHASE3,315.0,ACTUAL,Allergan,,2.0,,,f,,,,t,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 21:55:30.334217,2024-10-16 21:55:30.334217,INDUSTRY,,,,,,,2022,1.0
NCT03491462,,2018-03-27,2023-01-24,,2023-08-22,2018-04-06,2018-04-09,ACTUAL,2023-08-22,2023-08-24,ACTUAL,,,,2023-08-22,2023-08-24,ACTUAL,2018-07-31,ACTUAL,2018-07-31,2023-08,2023-08-31,2020-12-18,ACTUAL,2020-12-18,2020-12-18,ACTUAL,2020-12-18,,INTERVENTIONAL,,All participants in the modified intention-to-treat (mITT) population,Arimoclomol in Amyotropic Lateral Sclerosis,"A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotropic Lateral Sclerosis",COMPLETED,,PHASE3,245.0,ACTUAL,ZevraDenmark,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 21:55:30.334217,2024-10-16 21:55:30.334217,INDUSTRY,,,,,,,2020,1.0
NCT02256124,,2014-09-17,,,2020-04-10,2014-10-01,2014-10-03,ESTIMATED,,,,,,,2020-04-10,2020-04-14,ACTUAL,2014-10,,2014-10-31,2020-04,2020-04-30,2020-04,ACTUAL,2020-04-30,2020-04,ACTUAL,2020-04-30,,INTERVENTIONAL,NF1-EXCEL,,Effect of Lamotrigine on Cognition in NF1,The Effect of Lamotrigine on Cognitive Deficits Associated With Neurofibromatosis Type 1: a Phase II Randomized Controlled Multi-centre Trial (NF1-EXCEL),TERMINATED,,PHASE2/PHASE3,41.0,ACTUAL,Erasmus Medical Center,,2.0,,"Due to our experience, the small number of new inclusions, and the uncertainty regarding the COVID-19 outbreak, we have decided to discontinue the study.",f,,,,t,,,,,,,,,,,,,2024-10-16 21:55:30.334217,2024-10-16 21:55:30.334217,OTHER,,,,,,,2020,0.0
NCT02737930,,2016-04-01,2021-08-04,,2021-09-16,2016-04-13,2016-04-14,ESTIMATED,2021-09-16,2021-10-13,ACTUAL,,,,2021-09-16,2021-10-13,ACTUAL,2016-05,,2016-05-31,2021-09,2021-09-30,2020-08,ACTUAL,2020-08-31,2020-08,ACTUAL,2020-08-31,,INTERVENTIONAL,FLUORESCE,,Fluoxetine for Visual Recovery After Ischemic Stroke,Fluoxetine for Visual Recovery After Ischemic Stroke,TERMINATED,,PHASE2,17.0,ACTUAL,University of Rochester,,2.0,,Slow recruitment and lack of funding to expand to other sites.,f,,,,,t,f,,,,,,,,,,,2024-10-16 21:55:30.334217,2024-10-16 21:55:30.334217,OTHER,,,,,,,2020,0.0
NCT03123289,,2017-04-04,,,2021-04-12,2017-04-18,2017-04-21,ACTUAL,,,,,,,2021-04-12,2021-04-15,ACTUAL,2017-03-06,ACTUAL,2017-03-06,2021-04,2021-04-30,2020-10-14,ACTUAL,2020-10-14,2020-10-14,ACTUAL,2020-10-14,,INTERVENTIONAL,,,Novel Gallium 68 Citrate in Orthopedic Infections,Novel Gallium 68 Citrate in Orthopedic Infections,TERMINATED,,PHASE2,1.0,ACTUAL,"Rutgers, The State University of New Jersey",,2.0,,PI left the institute and the funding expired.,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,OTHER,,,,,,,2020,0.0
NCT05166031,,2020-10-26,,,2021-12-29,2021-12-08,2021-12-21,ACTUAL,,,,,,,2021-12-29,2022-01-14,ACTUAL,2020-12,ESTIMATED,2020-12-31,2021-12,2021-12-31,2021-10-18,ESTIMATED,2021-10-18,2021-04,ESTIMATED,2021-04-30,,INTERVENTIONAL,,,Evaluation of the Immunogenicity and Safety of Concomitant Administration of Novel Oral Polio Type 2 Vaccine and Bivalent Oral Polio Vaccine,A Phase III Study to Evaluate the Immunogenicity and Safety of Concomitant Administration of Two Doses of a Novel Oral Polio Type 2 Vaccine and Bivalent Oral Polio Vaccine in Healthy Infants,WITHDRAWN,,PHASE3,0.0,ACTUAL,Fidec Corporation,,3.0,,Sponsor decided not to conduct it,f,,,,t,f,f,,,,,,,,,,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,OTHER,,,,,,,2021,0.0
NCT01869361,,2013-05-29,,,2021-11-23,2013-05-31,2013-06-05,ESTIMATED,,,,,,,2021-11-23,2021-12-07,ACTUAL,2020-08-01,ACTUAL,2020-08-01,2021-11,2021-11-30,2021-11-23,ACTUAL,2021-11-23,2021-11-23,ACTUAL,2021-11-23,,INTERVENTIONAL,,,Indomethacin for Tocolysis of Preterm Labor,"Randomized, Placebo Controlled Trial of Indomethacin for Tocolysis",WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,MetroHealth Medical Center,,2.0,,"Due to much lower than expected numbers of eligible patients and lack of PI time, the study was not started.",f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,OTHER,,,,,,,2021,0.0
NCT03897062,,2019-03-26,,,2023-02-13,2019-03-29,2019-04-01,ACTUAL,,,,,,,2023-02-13,2023-02-15,ACTUAL,2019-08-26,ACTUAL,2019-08-26,2023-02,2023-02-28,2022-07-31,ACTUAL,2022-07-31,2022-07-31,ACTUAL,2022-07-31,,INTERVENTIONAL,,,Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence,"A Placebo-controlled, Double -Blind Randomised Trial of Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence",TERMINATED,,PHASE2,22.0,ACTUAL,The Florey Institute of Neuroscience and Mental Health,,2.0,,Recruitment problems during covid lockdowns resulted in Merck ceasing supply of suvorexant/placebo,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,OTHER,,,,,,,2022,0.0
NCT03461406,,2018-03-02,2023-01-24,,2023-04-12,2018-03-08,2018-03-12,ACTUAL,2023-03-14,2023-04-07,ACTUAL,,,,2023-04-12,2023-04-14,ACTUAL,2019-01-18,ACTUAL,2019-01-18,2023-04,2023-04-30,2022-05-20,ACTUAL,2022-05-20,2022-04-15,ACTUAL,2022-04-15,,INTERVENTIONAL,,"Intent-to-Treat (ITT) population included all participants who were randomized, regardless of meeting intra-operative enrollment criteria and regardless of whether the IP was administered to the participant.",A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants,"A Prospective, Randomized, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis During Surgery in Paediatric Subjects",COMPLETED,,PHASE3,186.0,ACTUAL,Grifols Therapeutics LLC,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,INDUSTRY,,,,,,,2022,1.0
NCT02884908,,2016-08-26,2023-10-23,,2024-02-15,2016-08-26,2016-08-31,ESTIMATED,2024-02-15,2024-03-13,ACTUAL,,,,2024-02-15,2024-03-13,ACTUAL,2017-07-07,ACTUAL,2017-07-07,2024-02,2024-02-29,2022-01-19,ACTUAL,2022-01-19,2022-01-19,ACTUAL,2022-01-19,,INTERVENTIONAL,,,Pharmacogenetic Treatment With Anti-Glutaminergic Agents for Comorbid PTSD & AUD,Pharmacogenetic Treatment With Anti-Glutaminergic Agents for Comorbid PTSD & AUD,COMPLETED,,PHASE3,57.0,ACTUAL,"University of Maryland, Baltimore","Sample size calculated for effect size=0.31, attrition=25%, correlation among repeated measures=0.55. With power=0.80 \& alpha-level=.05/2=.025, N=198 randomized. Due to interruptions/pandemic, N=57 randomized; final analysis N=44 (26 pregabalin/18 placebo). Re-calculated power based on modified primary analysis, achieved sample size, observed attrition rates (40%), \& average correlation among repeated measures. Aim1 effect size=0.67, 2-sided alpha=0.05, power=0.80. Aim2 effect sizes=0.68 \& 0.63.",4.0,,,f,,,,t,t,f,,,f,,,,,,YES,"Following the NIH policy, and the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources, the investigators will provide all of our research resources available for research purposes to qualified individuals within the scientific community after publication of our results.~Sharing of all of the research resources generated by this funded project will be in accordance with the federal rules or regulations imposed upon by the University of Maryland, Baltimore. The investigators will make the results available in accordance with the NIH Data Sharing policy. The investigators will analyze data and submit for peer reviewed publications in scientific journals. The investigators will also present the data in scientific meetings, symposia, or other scientific communications consistent with academic standards.",2024-10-16 00:51:26.642858,2024-10-16 00:51:26.642858,OTHER,,,,,,,2022,1.0
NCT04575818,,2020-09-29,,,2021-05-07,2020-09-29,2020-10-05,ACTUAL,,,,,,,2021-05-07,2021-05-11,ACTUAL,2020-09-16,ACTUAL,2020-09-16,2021-05,2021-05-31,2021-04-08,ACTUAL,2021-04-08,2021-04-08,ACTUAL,2021-04-08,,INTERVENTIONAL,,,"A Study in Healthy Male Volunteers Investigating the Safety, Absorption and Elimination of Single Doses of GLPG4059","A First-in-human, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of GLPG4059 in Adult, Healthy, Male Subjects",TERMINATED,,PHASE1,32.0,ACTUAL,Galapagos NV,,5.0,,Development of compound has been stopped,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,INDUSTRY,,,,,,,2021,0.0
NCT03055312,,2017-01-09,,,2021-01-26,2017-02-13,2017-02-16,ACTUAL,,,,,,,2021-01-26,2021-01-28,ACTUAL,2016-12-20,ACTUAL,2016-12-20,2021-01,2021-01-31,2020-11-15,ACTUAL,2020-11-15,2020-11-15,ACTUAL,2020-11-15,,INTERVENTIONAL,SYSUCC-007,,Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer,"A Randomized, Multicenter,Phase III Study of Bicalutamide Versus Chemotherapy in First Line Treatment of AR Positive Metastatic Triple Negative Breast Cancer",TERMINATED,,PHASE3,36.0,ACTUAL,Sun Yat-sen University,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 21:55:30.334217,2024-10-16 21:55:30.334217,OTHER,,,,,,,2020,0.0
NCT05158296,,2021-11-23,2022-11-15,,2024-07-11,2021-12-01,2021-12-15,ACTUAL,2024-07-11,2024-07-12,ACTUAL,,,,2024-07-11,2024-07-12,ACTUAL,2021-12-08,ACTUAL,2021-12-08,2022-12,2022-12-31,2022-10-12,ACTUAL,2022-10-12,2022-10-12,ACTUAL,2022-10-12,,INTERVENTIONAL,,,Study to Evaluate the Efficacy Safety and Tolerability of Ultevursen in Subjects With RP Due to Mutations in Exon 13 of the USH2A Gene (Sirius),"A Double-Masked, Randomized, Controlled, Multiple-Dose Study to Evaluate the Efficacy, Safety and Tolerability of Ultevursen in Subjects With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene (Sirius)",TERMINATED,,PHASE2/PHASE3,7.0,ACTUAL,Laboratoires Thea,Study prematurely terminated due to sponsor decision for reasons unrelated to safety.,3.0,,Business decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,INDUSTRY,,,,,,,2022,0.0
NCT03236649,,2017-07-26,,,2023-02-07,2017-07-28,2017-08-02,ACTUAL,,,,,,,2023-02-07,2023-02-08,ACTUAL,2017-09-20,ACTUAL,2017-09-20,2021-01,2021-01-31,2022-02-08,ACTUAL,2022-02-08,2022-02-08,ACTUAL,2022-02-08,,INTERVENTIONAL,,,The Phase III Study of Icaritin Versus Sorafenib in PD-L1 Positive Advanced Hepatocellular Carcinoma Subjects,"Comparison of Efficacy and Safety of Icaritin Versus Sorafenib in First-line Treatment of PD-L1 Positive Advanced Hepatocellular Carcinoma Subjects: a Multicenter, Randomized, Opened Phase III Clinical Trial",TERMINATED,,PHASE3,89.0,ACTUAL,"Beijing Shenogen Biomedical Co., Ltd",,2.0,,Because the clinical development plan has been changed.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,INDUSTRY,,,,,,,2022,0.0
NCT04155190,,2019-11-01,,,2023-05-29,2019-11-05,2019-11-07,ACTUAL,,,,,,,2023-05-29,2023-05-31,ACTUAL,2019-12-20,ACTUAL,2019-12-20,2023-05,2023-05-31,2021-04-23,ACTUAL,2021-04-23,2021-04-23,ACTUAL,2021-04-23,,INTERVENTIONAL,,,"An Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC","A Multicenter, Randomized, Double Blind, Vehicle-controlled, Phase 2 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Patients With Non-Gorlin High Frequency BCC",TERMINATED,,PHASE2,47.0,ACTUAL,"Sol-Gel Technologies, Ltd.",,2.0,,Terminated early due to low blinded event rate,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,INDUSTRY,,,,,,,2021,0.0
NCT02689141,,2016-01-29,,,2020-06-09,2016-02-18,2016-02-23,ESTIMATED,,,,,,,2020-06-09,2020-06-11,ACTUAL,2016-02-04,ACTUAL,2016-02-04,2020-06,2020-06-30,2020-02-06,ACTUAL,2020-02-06,2017-07-13,ACTUAL,2017-07-13,,INTERVENTIONAL,,,Sequential Regimen of Bendamustin-Debulking Followed by Ofatumumab and Ibrutinib in CLL Patients (CLL2-BIO),"Prospective, Open-label, Multicentre Phase-II Trial to Evaluate Efficacy and Safety of a Sequential Regimen of Bendamustine Followed by Ofatumumab and Ibrutinib Followed by Ibrutinib and Ofatumumab Maintenance in CLL Patients",COMPLETED,,PHASE2,66.0,ACTUAL,German CLL Study Group,,1.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,OTHER,,,,,,,2020,1.0
NCT03151772,,2017-05-09,,,2020-09-24,2017-05-10,2017-05-12,ACTUAL,,,,,,,2020-09-24,2020-09-28,ACTUAL,2018-01-29,ACTUAL,2018-01-29,2020-09,2020-09-30,2020-09-24,ACTUAL,2020-09-24,2020-09-24,ACTUAL,2020-09-24,,INTERVENTIONAL,INSIDE,,Bioavailability of Disulfiram and Metformin in Glioblastomas,Drug Level and Investigation of Novel Substances Indicated Downstream Effect in Glioblastoma,TERMINATED,,EARLY_PHASE1,3.0,ACTUAL,"Sahlgrenska University Hospital, Sweden",,2.0,,Problems with including patients,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,OTHER,,,,,,,2020,0.0
NCT05003102,,2021-07-29,,,2022-05-04,2021-08-05,2021-08-12,ACTUAL,,,,,,,2022-05-04,2022-05-10,ACTUAL,2023-02-20,ESTIMATED,2023-02-20,2022-05,2022-05-31,2023-06-30,ESTIMATED,2023-06-30,2023-06-30,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,Dexmedetomidine Cycling and Sleep in the Pediatric ICU,Dexmedetomidine Cycling and Sleep in the Pediatric ICU,WITHDRAWN,,PHASE4,0.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,"No enrollment, IRB closed",f,,,,f,t,f,,,t,,,,,,NO,There is no plan to make IPD available to other researchers,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,OTHER,,,,,,,2023,0.0
NCT04492358,,2020-07-28,,,2023-02-17,2020-07-29,2020-07-30,ACTUAL,,,,,,,2023-02-17,2023-02-21,ACTUAL,2020-10-22,ACTUAL,2020-10-22,2023-02,2023-02-28,2021-05-31,ACTUAL,2021-05-31,2021-05-31,ACTUAL,2021-05-31,,INTERVENTIONAL,,,"Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in a Transicional Care Center","Phase 2/3, Randomized, Open Study to Compare the Efficacy and Safety of Colchicine and Glucocorticoids Compared With the Standard of Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in a Transicional Care Center",TERMINATED,,PHASE2/PHASE3,54.0,ACTUAL,Fundacion Clinic per a la Recerca Biomédica,,2.0,,No candidates for the recruitment,f,,,,t,f,f,,,,,,,,,,,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,OTHER,,,,,,,2021,0.0
NCT04342689,,2020-04-08,2022-07-06,,2022-09-27,2020-04-08,2020-04-13,ACTUAL,2022-09-27,2022-10-05,ACTUAL,,,,2022-09-27,2022-10-05,ACTUAL,2020-06-03,ACTUAL,2020-06-03,2022-09,2022-09-30,2021-04-15,ACTUAL,2021-04-15,2021-04-15,ACTUAL,2021-04-15,,INTERVENTIONAL,,,The Role of Resistant Starch in COVID-19 Infection,The Role of Resistant Starch in COVID-19 Infection,TERMINATED,,PHASE2/PHASE3,226.0,ACTUAL,Yale University,,2.0,,Study was terminated due to low enrollment.,f,,,,t,t,f,,,,,,"After publication, indefinitely",,,YES,Deidentified data underlying results for publication are planned to be made available after publication.,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,OTHER,,,,,,,2021,0.0
NCT04790487,,2021-03-06,,,2023-10-12,2021-03-09,2021-03-10,ACTUAL,,,,,,,2023-10-12,2023-10-16,ACTUAL,2019-07-30,ACTUAL,2019-07-30,2023-10,2023-10-31,2021-12-30,ACTUAL,2021-12-30,2020-12-30,ACTUAL,2020-12-30,,INTERVENTIONAL,,,Chlorpheniramine Maleate Nasal Spray for Chronic Rhinitis,A Randomized Placebo Control Trial to Evaluate the Efficacy of Chlorpheniramine Maleate Nasal Spray vs. Placebo for Acute or Chronic Rhinitis,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Larkin Community Hospital,,2.0,,Study Period Ended/Not Completed,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,OTHER,,,,,,,2021,0.0
NCT05516849,,2022-08-16,,,2023-08-08,2022-08-24,2022-08-26,ACTUAL,,,,,,,2023-08-08,2023-08-14,ACTUAL,2022-05-19,ESTIMATED,2022-05-19,2023-08,2023-08-31,2023-08-03,ESTIMATED,2023-08-03,2023-08-03,ESTIMATED,2023-08-03,,INTERVENTIONAL,,,Placebo Versus Oxandrolone Supplementation in Trauma,Placebo Versus Oxandrolone Supplementation in Trauma: A Randomized Multi-Center Double Blind Clinical Trial in High-Energy Lower Extremity Trauma (POST-Injury Trial),WITHDRAWN,,PHASE3,0.0,ACTUAL,Sunnybrook Health Sciences Centre,,2.0,,"FDA requested manufacturers of Oxandrolone Tablets, to voluntarily remove previously approved drug applications for Oxandrolone from the U.S. market \& the funding decided to prematurely terminate the funding.",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,OTHER,,,,,,,2023,0.0
NCT04610827,,2020-10-26,2024-04-26,,2024-05-21,2020-10-26,2020-11-02,ACTUAL,2024-05-21,2024-05-22,ACTUAL,,,,2024-05-21,2024-05-22,ACTUAL,2020-11-16,ACTUAL,2020-11-16,2024-05,2024-05-31,2021-06-29,ACTUAL,2021-06-29,2021-06-29,ACTUAL,2021-06-29,,INTERVENTIONAL,,,Oral Iron Frequency for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder,Optimum Frequency and Timing of Oral Iron Administration for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder,TERMINATED,,PHASE4,6.0,ACTUAL,Mayo Clinic,Study terminated due to change in personnel and lack of resources to continue.,3.0,,Change in personnel and lack of resources to continue.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,OTHER,,,,,,,2021,0.0
NCT04580277,,2020-10-02,2023-11-22,,2024-03-28,2020-10-02,2020-10-08,ACTUAL,2024-03-28,2024-04-04,ACTUAL,,,,2024-03-28,2024-04-04,ACTUAL,2021-01-25,ACTUAL,2021-01-25,2024-03,2024-03-31,2023-05-15,ACTUAL,2023-05-15,2022-12-01,ACTUAL,2022-12-01,,INTERVENTIONAL,,,Tofacitinib For Treatment Of Chronic Pouchitis,A Single Center Open-Label Prospective Study Of Oral Tofacitinib In Patients With Chronic Pouchitis,TERMINATED,,PHASE2,6.0,ACTUAL,Cedars-Sinai Medical Center,"Limitations of this study included a single center design, small sample size, and absence of a control arm. This study also lacked long-term follow-up data to assess durability of response to tofacitinib and its long-term safety in chronic pouchitis. This study also only included patients with chronic pouchitis and its findings may not be applicable to other chronic inflammatory pouch disorders. Study recruitment was terminated prematurely due to COVID-19 pandemic-related recruitment challenges.",1.0,,low recruitment,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,OTHER,,,,,,,2023,0.0
NCT02720601,,2016-03-23,,,2018-01-23,2016-03-23,2016-03-28,ESTIMATED,,,,,,,2018-01-23,2018-01-25,ACTUAL,2015-11,,2015-11-30,2018-01,2018-01-31,2020-03,ESTIMATED,2020-03-31,2018-03,ESTIMATED,2018-03-31,,INTERVENTIONAL,,,Irinotecan and Capecitabine as Second-line Treatment for Advanced/Metastatic Biliary Tract Cancers,A Phase II Trial of Combination Irinotecan and Capecitabine as Second-Line Treatment for Patients With Locally Advanced/Metastatic Biliary Tract Cancers Who Progressed or Intolerant to Front-Line Gemcitabine and Platinum Combination,WITHDRAWN,,PHASE2,0.0,ACTUAL,New Mexico Cancer Care Alliance,,1.0,,Study was never submitted to the IRB \& never opened. PI is leaving institution.,f,,,,t,,,,,,,,,,,,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,OTHER,,,,,,,2020,0.0
NCT04411602,,2020-05-22,,,2021-07-06,2020-05-29,2020-06-02,ACTUAL,,,,,,,2021-07-06,2021-07-09,ACTUAL,2020-04-07,ACTUAL,2020-04-07,2021-07,2021-07-31,2021-04-07,ACTUAL,2021-04-07,2021-04-07,ACTUAL,2021-04-07,,INTERVENTIONAL,,,Intermediate IND Severe Illness COVID-19 CP,Intermediate IND Severe Illness COVID-19 CP,WITHDRAWN,,PHASE1,0.0,ACTUAL,Ascension South East Michigan,,1.0,,No participants due to waning pandemic.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,OTHER,,,,,,,2021,0.0
NCT03991299,,2019-06-07,2022-11-18,,2023-02-06,2019-06-18,2019-06-19,ACTUAL,2023-02-06,2023-02-28,ACTUAL,,,,2023-02-06,2023-02-28,ACTUAL,2021-04-29,ACTUAL,2021-04-29,2023-02,2023-02-28,2022-02-11,ACTUAL,2022-02-11,2022-02-11,ACTUAL,2022-02-11,,INTERVENTIONAL,,Participants analysis not done.,"Investigating Effects of BOTOX on Weight Loss and Glucose Tolerance in Obese, Type 2 Diabetic Subjects","Investigating Effects of BOTOX on Weight Loss and Glucose Tolerance in Obese, Type 2 Diabetic Subjects",TERMINATED,,PHASE1/PHASE2,4.0,ACTUAL,Vanderbilt University Medical Center,Early termination leading to small numbers of subjects enrolled.~Technical problems due to limited enrollment leading to uninterpretable data.,1.0,,Sponsor Decision.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 21:55:30.334217,2024-10-16 21:55:30.334217,OTHER,,,,,,,2022,0.0
NCT04224688,,2020-01-08,2023-05-15,2022-12-19,2023-08-04,2020-01-08,2020-01-13,ACTUAL,2023-08-04,2023-08-08,ACTUAL,,2023-08-08,ACTUAL,2023-08-04,2023-08-08,ACTUAL,2020-06-03,ACTUAL,2020-06-03,2023-08,2023-08-31,2022-05-05,ACTUAL,2022-05-05,2022-04-25,ACTUAL,2022-04-25,,INTERVENTIONAL,myOpportunITy2,Baseline Characteristics refer to Randomized Set which consisted of all enrolled study participants who were randomized.,"A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)","A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)",TERMINATED,,PHASE3,30.0,ACTUAL,UCB Pharma,,2.0,,Strategic Business Decision; Not a safety decision,f,,,,t,t,f,,,f,,,"Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",https://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,INDUSTRY,,,,,,,2022,0.0
NCT03626662,,2018-06-19,,,2023-10-17,2018-08-09,2018-08-13,ACTUAL,,,,,,,2023-10-17,2023-10-18,ACTUAL,2018-07-30,ACTUAL,2018-07-30,2023-10,2023-10-31,2023-04-18,ACTUAL,2023-04-18,2023-04-18,ACTUAL,2023-04-18,,INTERVENTIONAL,,,"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)","A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)",COMPLETED,,PHASE1,79.0,ACTUAL,Amgen,,2.0,,,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-16 21:55:30.334217,2024-10-16 21:55:30.334217,INDUSTRY,,,,,,,2023,1.0
NCT05597722,,2022-10-27,2024-05-07,,2024-06-26,2022-10-27,2022-10-28,ACTUAL,2024-06-26,2024-07-22,ACTUAL,,,,2024-06-26,2024-07-22,ACTUAL,2023-04-04,ACTUAL,2023-04-04,2023-05,2023-05-31,2023-05-18,ACTUAL,2023-05-18,2023-05-18,ACTUAL,2023-05-18,,INTERVENTIONAL,,The study was terminated prior to any baseline assessments being analyzed.,Addressing Cognitive Fog in Long-COVID-19 Patients,Randomized Study to Evaluate Strategies to Address Cognitive Fog in Long-COVID-19 Patients,TERMINATED,,PHASE4,7.0,ACTUAL,University of Pittsburgh,,2.0,,"Due to the evolving nature of COVID-related cognitive fog, it was determined that the study would be terminated at this time. The team agreed that it isn't feasible to collect enough data to evaluate the efficacy of the treatments.",f,,,,t,t,f,,,f,,,,,,NO,Individual participant data will not be shared. Data is shared at the aggregate level.,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,OTHER,,,,,,,2023,0.0
NCT05354856,,2022-02-15,,,2024-04-30,2022-04-26,2022-05-02,ACTUAL,,,,,,,2024-04-30,2024-05-02,ACTUAL,2022-03-11,ACTUAL,2022-03-11,2024-04,2024-04-30,2023-12-30,ACTUAL,2023-12-30,2023-12-29,ACTUAL,2023-12-29,,INTERVENTIONAL,,,The Effect of Chemoradiotherapy on Gastric Perfusion in Patients With Gastric Cancer.,The Effect of Chemoradiotherapy on Gastric Perfusion in Patients With Gastric Cancer.,TERMINATED,,PHASE4,11.0,ACTUAL,"Rigshospitalet, Denmark",,1.0,,recruiting issues,f,,,,t,f,f,,,,,,,,,,,2024-10-16 21:55:30.334217,2024-10-16 21:55:30.334217,OTHER,,,,,,,2023,0.0
NCT04109066,,2019-09-27,2024-01-12,,2024-02-13,2019-09-27,2019-09-30,ACTUAL,2024-02-13,2024-03-12,ACTUAL,,,,2024-02-13,2024-03-12,ACTUAL,2019-11-20,ACTUAL,2019-11-20,2024-02,2024-02-29,2023-12-27,ACTUAL,2023-12-27,2023-01-16,ACTUAL,2023-01-16,,INTERVENTIONAL,CheckMate 7FL,,"Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer","A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer",COMPLETED,,PHASE3,521.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,t,,,,t,t,f,,,,,,,,,,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,INDUSTRY,,NCT02475382,NO_LONGER_AVAILABLE,,,,2023,1.0
NCT05594667,,2022-10-19,,,2023-07-04,2022-10-25,2022-10-26,ACTUAL,,,,,,,2023-07-04,2023-07-06,ACTUAL,2023-01-01,ACTUAL,2023-01-01,2023-07,2023-07-31,2023-03-14,ACTUAL,2023-03-14,2023-03-14,ACTUAL,2023-03-14,,INTERVENTIONAL,,,Effect of SSRIs on Response to Psilocybin Therapy,Evaluating the Effect of Length of Time on Selective Serotonin Reuptake Inhibitors (SSRIs) on the Response to Psilocybin-assisted Therapy in Individuals With Mild-moderate Major Depressive Disorder (MDD),WITHDRAWN,,PHASE2,0.0,ACTUAL,Cybin Therapeutics Inc.,,1.0,,Funding,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,INDUSTRY,,,,,,,2023,0.0
NCT02674958,,2016-01-06,,,2023-01-12,2016-02-02,2016-02-05,ESTIMATED,,,,,,,2023-01-12,2023-01-17,ACTUAL,2016-05,ACTUAL,2016-05-31,2023-01,2023-01-31,2022-04-01,ACTUAL,2022-04-01,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,TROPHIC 3,,Mobilization of Endothelial Progenitor Cells and Aspirin,Mobilization of Endothelial Progenitor Cells Following Alcohol Septal Ablation in Hypertrophic Obstructive Cardiomyopathy: Randomized Controlled Trial of Aspirin,TERMINATED,,PHASE3,6.0,ACTUAL,Ottawa Heart Institute Research Corporation,,2.0,,Covid-19 pandemic,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-16 21:55:30.334217,2024-10-16 21:55:30.334217,OTHER,,,,,,,2022,0.0
NCT02387229,,2015-02-26,,,2024-06-05,2015-03-06,2015-03-12,ESTIMATED,,,,,,,2024-06-05,2024-06-06,ACTUAL,2015-03,ACTUAL,2015-03-31,2024-06,2024-06-30,2024-05-18,ACTUAL,2024-05-18,2024-05-18,ACTUAL,2024-05-18,,INTERVENTIONAL,BRAIN-AF,,Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in AF,Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in AF (BRAIN-AF),TERMINATED,,PHASE3,1238.0,ACTUAL,Montreal Heart Institute,,2.0,,Consensus BRAIN-AF Executive Steering Committee to terminate.,f,,,,t,,,,,,,,,,,,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,OTHER,,,,,,,2024,0.0
NCT05044325,,2021-09-06,2023-11-03,,2023-11-03,2021-09-06,2021-09-14,ACTUAL,2023-11-03,2024-05-02,ACTUAL,,,,2023-11-03,2024-05-02,ACTUAL,2021-09-20,ACTUAL,2021-09-20,2023-11,2023-11-30,2022-08-05,ACTUAL,2022-08-05,2022-08-05,ACTUAL,2022-08-05,,INTERVENTIONAL,,,"A First Time in Human (FTIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK3884464 in Healthy Participants","A Two-Part First Time in Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Oral Doses of GSK3884464 in a Randomized, Double Blind, Placebo-Controlled, Dose Escalation Study in Healthy Participants",TERMINATED,,PHASE1,27.0,ACTUAL,GlaxoSmithKline,,10.0,,To allow for additional assessments from supplementary non-clinical activities.,f,,,,f,f,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,INDUSTRY,,,,,,,2022,0.0
NCT04433546,,2020-05-28,,,2020-12-09,2020-06-13,2020-06-16,ACTUAL,,,,,,,2020-12-09,2020-12-11,ACTUAL,2020-07-15,ACTUAL,2020-07-15,2020-12,2020-12-31,2020-12-02,ACTUAL,2020-12-02,2020-12-02,ACTUAL,2020-12-02,,INTERVENTIONAL,VANGARD,,"Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS).","A Randomized, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of Once Weekly Subcutaneous Injections of Pemziviptadil (PB1046), a Sustained-Release VIP (Vasoactive Intestinal Peptide) ANalogue, in Hospitalized COVID-19 Patients at HiGh Risk for Rapid Clinical Deterioration and ARDS (PB1046 VANGARD Study)",TERMINATED,,PHASE2,54.0,ACTUAL,PhaseBio Pharmaceuticals Inc.,,3.0,,Company no longer pursing indication,f,,,,t,t,f,,,,,,,,,,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,INDUSTRY,,,,,,,2020,0.0
NCT02908672,,2016-09-19,2020-09-15,,2024-09-13,2016-09-19,2016-09-21,ESTIMATED,2020-10-26,2020-11-19,ACTUAL,,,,2024-09-13,2024-10-01,ACTUAL,2017-01-13,ACTUAL,2017-01-13,2024-09,2024-09-30,2024-07-01,ACTUAL,2024-07-01,2019-10-11,ACTUAL,2019-10-11,,INTERVENTIONAL,,,A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma,"A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma",COMPLETED,,PHASE3,514.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,INDUSTRY,,,,,,,2024,1.0
NCT05020665,,2021-08-19,2023-12-19,,2023-12-19,2021-08-19,2021-08-25,ACTUAL,2023-12-19,2024-01-10,ACTUAL,,,,2023-12-19,2024-01-10,ACTUAL,2021-11-24,ACTUAL,2021-11-24,2023-12,2023-12-31,2023-03-30,ACTUAL,2023-03-30,2023-03-30,ACTUAL,2023-03-30,,INTERVENTIONAL,,,Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML,"A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Entospletinib in Combination With Intensive Induction and Consolidation Chemotherapy in Adults With Newly Diagnosed Nucleophosmin 1-mutated Acute Myeloid Leukemia",TERMINATED,,PHASE3,15.0,ACTUAL,Kronos Bio,"Early termination was due to significant unforeseen challenges associated with global enrollment of participants with genetically-defined, newly diagnosed, AML who are candidates for intensive induction therapy and other challenges associated with post-COVID impacts.",2.0,,Termination was due to significant challenges associated with study enrollment in a genetic subset of fit participants in the front-line acute myeloid leukemia (AML) setting and other challenges associated with post-COVID impacts.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 21:55:30.334217,2024-10-16 21:55:30.334217,INDUSTRY,,,,,,,2023,0.0
NCT04532554,,2020-08-24,,,2020-09-15,2020-08-28,2020-08-31,ACTUAL,,,,,,,2020-09-15,2020-09-16,ACTUAL,2020-10-26,ESTIMATED,2020-10-26,2020-09,2020-09-30,2020-12-20,ESTIMATED,2020-12-20,2020-12-10,ESTIMATED,2020-12-10,,INTERVENTIONAL,,,Growth Hormone in Obese Cases With Covid-19,The Impact of Growth Hormone in Obese Cases With Covid-19,WITHDRAWN,,PHASE4,0.0,ACTUAL,ClinAmygate,,2.0,,No participants enrolled,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,OTHER,,,,,,,2020,0.0
NCT03167957,,2017-05-23,,,2019-03-06,2017-05-24,2017-05-30,ACTUAL,,,,,,,2019-03-06,2019-03-08,ACTUAL,2019-12,ESTIMATED,2019-12-31,2019-03,2019-03-31,2020-12,ESTIMATED,2020-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis,"A Single-Center, Open-Label, Pilot Study to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Matinas BioPharma Nanotechnologies, Inc.",,2.0,,No longer target indication,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,INDUSTRY,,,,,,,2020,0.0
NCT04962230,,2021-07-10,2022-09-08,,2023-10-06,2021-07-10,2021-07-14,ACTUAL,2023-10-06,2023-10-10,ACTUAL,,,,2023-10-06,2023-10-10,ACTUAL,2021-07-15,ACTUAL,2021-07-15,2023-10,2023-10-31,2021-10-09,ACTUAL,2021-10-09,2021-10-09,ACTUAL,2021-10-09,,INTERVENTIONAL,,All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.,Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With Ritonavir,"A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD CROSSOVER STUDY TO ESTIMATE THE EFFECT OF CARBAMAZEPINE ON THE PHARMACOKINETICS OF PF-07321332 BOOSTED WITH RITONAVIR IN HEALTHY PARTICIPANTS",COMPLETED,,PHASE1,12.0,ACTUAL,Pfizer,,2.0,,,,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,INDUSTRY,,,,,,,2021,1.0
NCT04869228,,2021-04-29,,,2023-08-14,2021-04-29,2021-05-03,ACTUAL,,,,,,,2023-08-14,2023-08-18,ACTUAL,2021-08-04,ACTUAL,2021-08-04,2023-08,2023-08-31,2023-08-02,ACTUAL,2023-08-02,2022-09-02,ACTUAL,2022-09-02,,INTERVENTIONAL,,,"A Phase 3 Randomized, Double-Blind Placebo Controlled, Multi-regional Trial to Evaluate the Efficacy and Safety of GT0918 for the Treatment of Mild to Moderate COVID-19 Male Patients","A Phase 3 Randomized, Double-Blind Placebo Controlled, Multi-regional Trial to Evaluate the Efficacy and Safety of GT0918 for the Treatment of Mild to Moderate COVID-19 Male Patients",TERMINATED,,PHASE3,380.0,ACTUAL,"Suzhou Kintor Pharmaceutical Inc,",,2.0,,This decision is made on changing the development strategy of GT0918 to adapt ever-changing COVID-19 pandemic management globally.,f,,,,,f,f,,,f,,,,,,,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,INDUSTRY,,,,,,,2023,0.0
NCT05244070,,2022-02-08,,,2023-07-14,2022-02-08,2022-02-17,ACTUAL,,,,,,,2023-07-14,2023-07-18,ACTUAL,2022-09-14,ACTUAL,2022-09-14,2023-07,2023-07-31,2023-05-04,ACTUAL,2023-05-04,2023-05-04,ACTUAL,2023-05-04,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Tolerability of BMS-986403 in Participants With Relapsed and/or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma,"A Phase 1, Multicenter, Open-label Study of BMS-986403 in Subjects With Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)",TERMINATED,,PHASE1,5.0,ACTUAL,Bristol-Myers Squibb,,1.0,,Business objectives have changed.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 21:55:30.334217,2024-10-16 21:55:30.334217,INDUSTRY,,,,,,,2023,0.0
NCT04045730,,2019-07-02,,,2020-01-06,2019-08-02,2019-08-05,ACTUAL,,,,,,,2020-01-06,2020-01-09,ACTUAL,2019-11-15,ESTIMATED,2019-11-15,2020-01,2020-01-31,2021-07-31,ESTIMATED,2021-07-31,2019-12-31,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,The Study of Gemcitabine Plus Nab-Paclitaxel in Combination With Pegvorhyaluronidase Alfa (PVHA; PEGPH20) and Pembrolizumab as Front-line Treatment for Metastatic Pancreatic Adenocarcinoma.,A Single Arm Phase 2 Study of Gemcitabine Plus Nab-Paclitaxel in Combination With Pegvorhyaluronidase Alfa (PVHA; PEGPH20) and Pembrolizumab as Front-line Treatment for Metastatic Pancreatic Adenocarcinoma.,WITHDRAWN,,PHASE2,0.0,ACTUAL,Yale University,,1.0,,Halozyme isn't allowing this trial to move forward until their current clinical trial results are released.,f,,,,,f,f,,,,,,,,,,,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,OTHER,,,,,,,2021,0.0
NCT04267939,,2020-02-11,,,2023-12-18,2020-02-11,2020-02-13,ACTUAL,,,,,,,2023-12-18,2023-12-21,ACTUAL,2020-02-26,ACTUAL,2020-02-26,2023-12,2023-12-31,2023-12-01,ACTUAL,2023-12-01,2023-12-01,ACTUAL,2023-12-01,,INTERVENTIONAL,,,ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer,"An Open-label Phase 1b Study to Determine the Maximum Tolerated and/or Recommended Phase 2 Dose of the ATR Inhibitor Elimusertib (BAY 1895344) in Combination With PARP Inhibitor Niraparib, in Participants With Recurrent Advanced Solid Tumors and Ovarian Cancer",TERMINATED,,PHASE1,14.0,ACTUAL,Bayer,,6.0,,There was no anticipated benefit of the experimental combination as tested over available standard therapies; therefore Sponsor has decided to terminate the investigation.,f,,,,f,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,INDUSTRY,,,,,,,2023,0.0
NCT04200989,,2019-12-12,,,2022-11-18,2019-12-13,2019-12-16,ACTUAL,,,,,,,2022-11-18,2022-11-22,ACTUAL,2021-03-01,ESTIMATED,2021-03-01,2021-02,2021-02-28,2021-12-31,ESTIMATED,2021-12-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Novel Treatment for Patients With Peanut Allergy: Intralymphatic Immunotherapy,Intra-lymphatic Immunotherapy for the Management of Peanut Allergy,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Scripps Health,,1.0,,Lack of funding,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 21:55:30.334217,2024-10-16 21:55:30.334217,OTHER,,,,,,,2021,0.0
NCT02590601,,2015-10-12,,,2023-03-31,2015-10-27,2015-10-29,ESTIMATED,,,,,,,2023-03-31,2023-04-04,ACTUAL,2017-01-01,ACTUAL,2017-01-01,2023-03,2023-03-31,2023-01-01,ESTIMATED,2023-01-01,2023-01-01,ESTIMATED,2023-01-01,,INTERVENTIONAL,BRO-HF,,Bromocriptine in the Treatment of Peripartum Cardiomyopathy,"Bromocriptine in the Treatment of Peripartum Cardiomyopathy, A Bayesian Randomized Registry Trial",WITHDRAWN,,PHASE3,0.0,ACTUAL,Montreal Heart Institute,,2.0,,Not enough patients,f,,,,t,,,,,,,,,,,,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,OTHER,,,,,,,2023,0.0
NCT04856007,,2021-04-09,,,2022-04-25,2021-04-20,2021-04-22,ACTUAL,,,,,,,2022-04-25,2022-04-29,ACTUAL,2021-04-12,ACTUAL,2021-04-12,2022-04,2022-04-30,2021-06-14,ACTUAL,2021-06-14,2021-06-14,ACTUAL,2021-06-14,,INTERVENTIONAL,,,A Study to Assess the Bioequivalence of Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Healthy Chinese Subjects.,"A Single-centre, Parallel-cohort, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects in the Fed State.",COMPLETED,,PHASE1,80.0,ACTUAL,AstraZeneca,,4.0,,,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-16 21:55:30.334217,2024-10-16 21:55:30.334217,INDUSTRY,,,,,,,2021,1.0
NCT04557475,,2020-09-15,,,2021-06-11,2020-09-15,2020-09-21,ACTUAL,,,,,,,2021-06-11,2021-06-16,ACTUAL,2022-06-11,ESTIMATED,2022-06-11,2021-06,2021-06-30,2023-06-11,ESTIMATED,2023-06-11,2023-06-11,ESTIMATED,2023-06-11,,INTERVENTIONAL,,,Transplacental Aspirin Therapy for Early Onset Fetal Growth Restriction,A Randomized Trial of Transplacental Aspirin Therapy for Early Onset Fetal Growth,WITHDRAWN,,PHASE3,0.0,ACTUAL,Johns Hopkins University,,2.0,,We are modifying this trial's protocol and will resubmit a new application at a later date.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,OTHER,,,,,,,2023,0.0
NCT02867618,,2016-08-09,2021-06-28,,2021-06-28,2016-08-11,2016-08-16,ESTIMATED,2021-06-28,2021-07-16,ACTUAL,,,,2021-06-28,2021-07-16,ACTUAL,2016-10-16,ACTUAL,2016-10-16,2021-06,2021-06-30,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,"3 out of 14 subjects were enrolled but not accrued into study; however, baseline information was collected for all 14 subjects.",Carfilzomib and TGR-1202 in Treatment of R/R Lymphoma,Phase I/II Study of Carfilzomib and a PI3Kdelta Inhibitor TGR-1202 in the Treatment of Patients With Relapsed or Refractory Lymphoma,TERMINATED,,PHASE1/PHASE2,14.0,ACTUAL,Columbia University,,1.0,,PI left institution,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,OTHER,,,,,,,2020,0.0
NCT04975022,,2021-07-21,,,2021-07-22,2021-07-22,2021-07-23,ACTUAL,,,,,,,2021-07-22,2021-07-28,ACTUAL,2019-12-10,ACTUAL,2019-12-10,2021-07,2021-07-31,2020-08-14,ACTUAL,2020-08-14,2020-08-14,ACTUAL,2020-08-14,,INTERVENTIONAL,,,A Study Evaluating the Bioavailability of Oral Insulin (N11005),Research on Clinical Application of New Therapies for Diabetes and Its Complications and Related Translational Medicine Research,COMPLETED,,PHASE1,12.0,ACTUAL,Beijing Hospital,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,OTHER_GOV,,,,,,,2020,1.0
NCT02201108,,2014-07-17,2020-10-20,,2024-08-12,2014-07-24,2014-07-25,ESTIMATED,2020-11-27,2020-11-30,ACTUAL,,,,2024-08-12,2024-08-29,ACTUAL,2014-07-16,ACTUAL,2014-07-16,2024-08,2024-08-31,2024-07-29,ACTUAL,2024-07-29,2019-10-25,ACTUAL,2019-10-25,,INTERVENTIONAL,TERIKIDS,Analysis was performed on all randomized participants.,"Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis","A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension",COMPLETED,,PHASE3,166.0,ACTUAL,Sanofi,,2.0,,,f,,,,t,t,,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 21:55:30.334217,2024-10-16 21:55:30.334217,INDUSTRY,,,,,,,2024,1.0
NCT03099499,,2017-03-23,,,2024-01-12,2017-03-28,2017-04-04,ACTUAL,,,,,,,2024-01-12,2024-01-16,ACTUAL,2017-06-08,ACTUAL,2017-06-08,2024-01,2024-01-31,2020-09-09,ACTUAL,2020-09-09,2020-09-09,ACTUAL,2020-09-09,,INTERVENTIONAL,,,Single Agent ONC201 in Recurrent or Metastatic Endometrial Cancer,A Phase 2 Study of Single Agent ONC201 in Recurrent or Metastatic Endometrial Cancer,TERMINATED,,PHASE2,19.0,ACTUAL,Fox Chase Cancer Center,,1.0,,Slow accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,OTHER,,,,,,,2020,0.0
NCT03616470,,2018-07-26,,,2024-07-26,2018-07-27,2018-08-06,ACTUAL,,,,,,,2024-07-26,2024-07-29,ACTUAL,2018-10-15,ACTUAL,2018-10-15,2024-07,2024-07-31,2024-03-31,ACTUAL,2024-03-31,2024-03-31,ACTUAL,2024-03-31,,INTERVENTIONAL,,,Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia,"A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered With Chemotherapy Versus Chemotherapy Alone in Patients With Relapsed/Refractory Acute Myeloid Leukemia",TERMINATED,,PHASE3,388.0,ACTUAL,GlycoMimetics Incorporated,,2.0,,Trial failed to meet primary endpoint.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,INDUSTRY,,,,,,,2024,0.0
NCT02704754,,2016-02-17,2022-03-02,,2023-01-23,2016-03-04,2016-03-10,ESTIMATED,2023-01-23,2023-02-15,ACTUAL,,,,2023-01-23,2023-02-15,ACTUAL,2016-05-01,ACTUAL,2016-05-01,2023-01,2023-01-31,2021-04-30,ACTUAL,2021-04-30,2021-04-30,ACTUAL,2021-04-30,,INTERVENTIONAL,,,Suvorexant and Trauma Related Insomnia,Suvorexant and Trauma Related Insomnia,COMPLETED,,PHASE4,41.0,ACTUAL,Howard University,,2.0,,,f,,,,f,,,,,,,,"now, for 5 years",reasonable request made directly to investigator,,YES,Reasonable requests will be accomodated via emailing the principal investigator.,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,OTHER,,,,,,,2021,1.0
NCT01954966,,2012-11-06,2022-04-26,,2022-06-07,2013-09-26,2013-10-07,ESTIMATED,2022-06-07,2022-07-05,ACTUAL,,,,2022-06-07,2022-07-05,ACTUAL,2010-11,ACTUAL,2010-11-30,2022-06,2022-06-30,2021-12,ACTUAL,2021-12-31,2021-12,ACTUAL,2021-12-31,,INTERVENTIONAL,,"A total of 81 participants were enrolled, but N = 15 were lost to early follow-up and were not randomized. Therefore, the analysis cohort includes N = 66 participants.",Progesterone and Brain Imaging Study,Multimodal Imaging of Progesterone/Neurosteroid Effects in Nicotine Addiction,COMPLETED,,PHASE4,81.0,ACTUAL,University of Pennsylvania,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,OTHER,,,,,,,2021,1.0
NCT02753127,,2016-04-25,2021-10-26,,2023-11-13,2016-04-26,2016-04-27,ESTIMATED,2022-03-30,2022-04-26,ACTUAL,,,,2023-11-13,2023-11-15,ACTUAL,2016-06,,2016-06-30,2023-11,2023-11-30,2021-05-12,ACTUAL,2021-05-12,2020-04-28,ACTUAL,2020-04-28,,INTERVENTIONAL,CanStem303C,,A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer,"A Phase 3 Study of BBI-608 in Combination With 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC).",COMPLETED,,PHASE3,1253.0,ACTUAL,"Sumitomo Pharma America, Inc.",,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,INDUSTRY,,,,,,,2021,1.0
NCT04474210,,2020-07-14,,,2021-07-19,2020-07-14,2020-07-16,ACTUAL,,,,,,,2021-07-19,2021-07-23,ACTUAL,2020-08-19,ACTUAL,2020-08-19,2021-07,2021-07-31,2020-11-30,ACTUAL,2020-11-30,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,,,A Study to Evaluate the Effect of Renal Impairment on JNJ-56136379 in Adult Participants,"An Open-Label, Single-Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-56136379 in Adult Participants",TERMINATED,,PHASE1,1.0,ACTUAL,"Janssen Research & Development, LLC",,5.0,,Strategic Decision,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,INDUSTRY,,,,,,,2020,0.0
NCT02126579,,2014-04-24,2022-04-28,,2024-02-02,2014-04-28,2014-04-30,ESTIMATED,2023-10-12,2023-11-03,ACTUAL,,,,2024-02-02,2024-02-28,ACTUAL,2014-05-01,ACTUAL,2014-05-01,2024-02,2024-02-29,2021-05-05,ACTUAL,2021-05-05,2019-11-20,ACTUAL,2019-11-20,,INTERVENTIONAL,MEL60,,Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists,"Open Label, Randomized, Phase I/II Study of a Long Peptide Vaccine Plus TLR Agonists for Resected Stage IIb-IV Melanoma. (MEL60)",COMPLETED,,PHASE1/PHASE2,50.0,ACTUAL,University of Virginia,,8.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,OTHER,,,,,,,2021,1.0
NCT03964337,,2019-05-23,2022-06-03,,2022-06-03,2019-05-23,2019-05-28,ACTUAL,2022-06-03,2022-06-29,ACTUAL,,,,2022-06-03,2022-06-29,ACTUAL,2020-03-17,ACTUAL,2020-03-17,2022-06,2022-06-30,2021-06-04,ACTUAL,2021-06-04,2021-06-04,ACTUAL,2021-06-04,,INTERVENTIONAL,SPARC,"Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B).",Immediate Prostatectomy vs. Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer,"A Phase II, Open-Label Randomized Study of Immediate Prostatectomy vs. Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer (SPARC)",TERMINATED,,PHASE2,3.0,ACTUAL,Duke University,"Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B).",2.0,,Poor accrual.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,OTHER,,,,,,,2021,0.0
NCT03980184,,2019-03-29,2023-11-26,,2024-03-18,2019-06-06,2019-06-10,ACTUAL,2024-01-05,2024-01-08,ACTUAL,,,,2024-03-18,2024-03-20,ACTUAL,2019-11-01,ACTUAL,2019-11-01,2024-03,2024-03-31,2022-11-30,ACTUAL,2022-11-30,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,,Data represented here is from participants that started treatment.,Guanfacine to Improve Substance Use Outcomes in Women,"The Use of Guanfacine (GUA) (3mg/Day) to Reduce Drug Craving, Improve Cognitive Flexibility and Result in Associated Lower Drug Use in Women With Substance Use Disorder (SUD).",COMPLETED,,PHASE2,74.0,ACTUAL,Yale University,"Small sample sizes, sample being limited to men were limitations. Caveats include small sample size limited examining treatment effects for specific drug use. Also, medication compliance moderated guanfacine effects on primary and secondary outcomes.",2.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,OTHER,,,,,,,2022,1.0
NCT02811783,,2016-06-15,,,2022-10-26,2016-06-22,2016-06-23,ESTIMATED,,,,,,,2022-10-26,2022-10-28,ACTUAL,2017-01,ACTUAL,2017-01-31,2022-10,2022-10-31,2022-09,ACTUAL,2022-09-30,2022-09,ACTUAL,2022-09-30,,INTERVENTIONAL,,,Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL,A Double Blind Randomized Vehicle Controlled Crossover Study to Evaluate the Safety and Efficacy of Topical Naloxone Hydrochloride Lotion 0.5% for the Relief of Pruritus in Patients With the MF or SS Forms of Cutaneous T-Cell Lymphoma,TERMINATED,,PHASE3,59.0,ACTUAL,"Elorac, Inc.",,2.0,,Sponsor decision,f,,,,f,,,,,,,,,,,NO,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,INDUSTRY,,,,,,,2022,0.0
NCT04498325,,2020-07-30,,,2021-07-29,2020-08-03,2020-08-04,ACTUAL,,,,,,,2021-07-29,2021-08-05,ACTUAL,2021-07-31,ESTIMATED,2021-07-31,2021-07,2021-07-31,2022-04-30,ESTIMATED,2022-04-30,2022-04-30,ESTIMATED,2022-04-30,,INTERVENTIONAL,,,"Evaluating the Effect of NT-I7, a Long Acting Interleukin-7, to Increase Lymphocyte Counts and Enhance Immune Clearance of SARS-CoV-2 (COVID-19)","A Phase I and Pilot Study Evaluating the Effect of NT-I7, a Long Acting Interleukin-7, to Increase Lymphocyte Counts and Enhance Immune Clearance of SARS-CoV-2",WITHDRAWN,,PHASE1,0.0,ACTUAL,Washington University School of Medicine,,3.0,,Principal investigator is leaving the institution.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,OTHER,,,,,,,2022,0.0
NCT01877655,,2013-06-12,2018-09-17,,2022-12-16,2013-06-12,2013-06-14,ESTIMATED,2018-11-01,2018-11-28,ACTUAL,,,,2022-12-16,2022-12-20,ACTUAL,2013-09-11,ACTUAL,2013-09-11,2022-12,2022-12-31,2022-03-01,ACTUAL,2022-03-01,2017-09-28,ACTUAL,2017-09-28,,INTERVENTIONAL,HELIOS,The analysis population was the All Randomized which consisted of all randomized participants whether they received study drug or not.,"A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)","A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)",COMPLETED,,PHASE3,514.0,ACTUAL,Astellas Pharma Inc,In Oct 2014 data monitoring committee informed Astellas of the results of the first futility analysis. The FDA considered data for 68 participants included in futility analysis compromised and asked that it is not included in final efficacy analysis.,2.0,,,f,,,,t,,,,,,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://www.clinicalstudydatarequest.com/,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,INDUSTRY,,,,,,,2022,1.0
NCT02407236,,2015-03-30,2019-11-15,2019-08-08,2023-01-03,2015-03-30,2015-04-02,ESTIMATED,2019-12-20,2019-12-23,ACTUAL,2019-08-08,2019-08-13,ACTUAL,2023-01-03,2023-01-05,ACTUAL,2015-07-10,ACTUAL,2015-07-10,2023-01,2023-01-31,2021-11-30,ACTUAL,2021-11-30,2018-08-10,ACTUAL,2018-08-10,,INTERVENTIONAL,UNIFI,The primary efficacy analysis set consisted of all participants randomized in the study.,A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis,"A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis",COMPLETED,,PHASE3,961.0,ACTUAL,"Janssen Research & Development, LLC",,10.0,,,f,,,,t,,f,,,,,,,,,,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,INDUSTRY,,,,,,,2021,1.0
NCT04047420,,2019-08-05,2023-09-14,,2023-12-04,2019-08-05,2019-08-06,ACTUAL,2023-12-04,2023-12-22,ACTUAL,,,,2023-12-04,2023-12-22,ACTUAL,2019-12-11,ACTUAL,2019-12-11,2023-12,2023-12-31,2021-04-07,ACTUAL,2021-04-07,2021-03-03,ACTUAL,2021-03-03,,INTERVENTIONAL,,,Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Administered Rectally,A Phase 1 Open Label Safety and Pharmacokinetic Study of Rectal Administration of a Tenofovir Alafenamide/Elvitegravir Insert at Two Dose Levels,COMPLETED,,PHASE1,23.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,1.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,NIH,,,,,,,2021,1.0
NCT04001231,,2019-05-07,,,2020-06-02,2019-06-25,2019-06-28,ACTUAL,,,,,,,2020-06-02,2020-06-04,ACTUAL,2020-06-30,ESTIMATED,2020-06-30,2020-05,2020-05-31,2021-07-02,ESTIMATED,2021-07-02,2021-07-02,ESTIMATED,2021-07-02,,INTERVENTIONAL,,,Study of Exenatide Once-Weekly Suspension in Chinese Patients With Type 2 Diabetes Mellitus,"A Phase 1, Open-Label Study to Evaluate Single and Multiple Dose Pharmacokinetics, Safety, and Tolerability of Exenatide Once-Weekly Suspension in Chinese Patients With Type 2 Diabetes Mellitus",WITHDRAWN,,PHASE1,0.0,ACTUAL,AstraZeneca,,1.0,,The study is stopped based upon strategic considerations impacting the clinical development of exenatide once-weekly suspension in China,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,INDUSTRY,,,,,,,2021,0.0
NCT04236141,,2020-01-16,2022-07-07,,2023-02-03,2020-01-20,2020-01-22,ACTUAL,2022-07-07,2022-08-04,ACTUAL,,,,2023-02-03,2023-03-03,ACTUAL,2020-07-10,ACTUAL,2020-07-10,2023-02,2023-02-28,2022-02-07,ACTUAL,2022-02-07,2021-07-12,ACTUAL,2021-07-12,,INTERVENTIONAL,,"ITT population included all participants randomized, whether or not the participants received the assigned treatment.",A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL).,"A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma.",TERMINATED,,PHASE3,42.0,ACTUAL,Hoffmann-La Roche,,2.0,,"Sponsor's decision, no safety concerns",f,,,,,t,f,,,t,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,INDUSTRY,,,,,,,2022,0.0
NCT04346667,,2020-04-13,,,2021-03-08,2020-04-14,2020-04-15,ACTUAL,,,,,,,2021-03-08,2021-03-10,ACTUAL,2020-04-14,ACTUAL,2020-04-14,2021-03,2021-03-31,2020-08-30,ACTUAL,2020-08-30,2020-08-23,ACTUAL,2020-08-23,,INTERVENTIONAL,PEACE,,Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds,Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Real Time Polymerase Chain Reaction (RT-PCR) Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Infectious Disease 2019 (COVID-19) Patients to RT- PCR-Negative as a Means to Reduce Hospitalization Rate,TERMINATED,,PHASE4,125.0,ACTUAL,"Government of Punjab, Specialized Healthcare and Medical Education Department",,4.0,,Poor accrual.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,OTHER_GOV,,,,,,,2020,0.0
NCT02998047,,2016-12-12,,,2022-02-22,2016-12-16,2016-12-20,ESTIMATED,,,,,,,2022-02-22,2022-03-08,ACTUAL,2016-12,,2016-12-31,2022-02,2022-02-28,2020-05,ACTUAL,2020-05-31,2020-05,ACTUAL,2020-05-31,,INTERVENTIONAL,,,A Phase I Study of Lintuzumab-Ac225 in Patients With Refractory Multiple Myeloma,A Phase I Study of Lintuzumab-Ac225 in Patients With Refractory Multiple Myeloma,TERMINATED,,PHASE1,2.0,ACTUAL,Actinium Pharmaceuticals,,1.0,,Poor recruitment,f,,,,t,,,,,,,,,,,NO,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,INDUSTRY,,,,,,,2020,0.0
NCT02466074,,2015-06-03,2023-02-03,,2023-03-31,2015-06-08,2015-06-09,ESTIMATED,2023-02-03,2023-03-01,ACTUAL,,,,2023-03-31,2023-04-27,ACTUAL,2016-08-17,ACTUAL,2016-08-17,2023-03,2023-03-31,2022-02-07,ACTUAL,2022-02-07,2022-02-07,ACTUAL,2022-02-07,,INTERVENTIONAL,perfuseMS,No participants were assigned to the placebo arm.,Augmenting Cerebral Blood Flow to Treat Established Multiple Sclerosis,Augmenting Cerebral Blood Flow to Treat Established Multiple Sclerosis,TERMINATED,,PHASE2,5.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,Inadequate recruitment; termination of funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,OTHER,,,,,,,2022,0.0
NCT00490139,,2007-06-20,2014-07-30,,2021-07-22,2007-06-20,2007-06-22,ESTIMATED,2014-07-30,2014-08-18,ESTIMATED,,,,2021-07-22,2021-07-23,ACTUAL,2007-05-16,ACTUAL,2007-05-16,2021-07,2021-07-31,2021-07-01,ACTUAL,2021-07-01,2013-12-06,ACTUAL,2013-12-06,,INTERVENTIONAL,ALTTO,,ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D,"A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer",COMPLETED,,PHASE3,8382.0,ACTUAL,Novartis,,4.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,INDUSTRY,,,,,,,2021,1.0
NCT04907968,,2021-05-12,,,2023-10-06,2021-05-25,2021-06-01,ACTUAL,,,,,,,2023-10-06,2023-10-10,ACTUAL,2021-06-11,ACTUAL,2021-06-11,2023-10,2023-10-31,2023-10-03,ACTUAL,2023-10-03,2023-10-03,ACTUAL,2023-10-03,,INTERVENTIONAL,UPGRADE,,Study of Upifitamab Rilsodotin in Combination With Carboplatin in Participants With High-grade Serous Ovarian Cancer,"Upifitamab Rilsodotin (Xmt-1536) An Open-Label, Multicenter, Dose Escalation And Expansion Study Of Upifitamab Rilsodotin In Combination With Carboplatin In Participants With High Grade Serous Ovarian Cancer (Upgrade-A)",TERMINATED,,PHASE1,31.0,ACTUAL,Mersana Therapeutics,,2.0,,Study Terminated by Sponsor,f,,,,f,t,f,,,,,,,,,,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,INDUSTRY,,,,,,,2023,0.0
NCT02876328,,2016-08-16,2022-07-14,,2024-06-14,2016-08-18,2016-08-23,ESTIMATED,2022-08-30,2022-09-28,ACTUAL,,,,2024-06-14,2024-06-26,ACTUAL,2017-03-27,ACTUAL,2017-03-27,2024-06,2024-06-30,2023-12-20,ACTUAL,2023-12-20,2019-12-24,ACTUAL,2019-12-24,,INTERVENTIONAL,PREVAC,,Partnership for Research on Ebola VACcinations,Partnership for Research on Ebola VACcinations (PREVAC),COMPLETED,,PHASE2,4789.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,5.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,NIH,,,,,,,2023,1.0
NCT02761694,,2016-04-29,2022-03-07,,2023-05-02,2016-05-03,2016-05-04,ESTIMATED,2022-06-14,2022-06-15,ACTUAL,,,,2023-05-02,2023-05-06,ACTUAL,2016-06-26,ACTUAL,2016-06-26,2023-05,2023-05-31,2021-03-10,ACTUAL,2021-03-10,2021-03-10,ACTUAL,2021-03-10,,INTERVENTIONAL,,,"Vevorisertib (ARQ 751) as a Single Agent or in Combination With Other Anti-Cancer Agents, in Solid Tumors With PIK3CA / AKT / PTEN Mutations (MK-4440-001)",A Phase 1b Study of ARQ 751 as a Single Agent or in Combination With Other Anti-cancer Agents in Adult Subjects With Advanced Solid Tumors With PIK3CA / AKT / PTEN Mutations,TERMINATED,,PHASE1,78.0,ACTUAL,"ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)",,12.0,,Business Reasons,f,,,,f,,,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,INDUSTRY,,,,,,,2021,0.0
NCT02277613,,2014-10-24,,,2021-07-21,2014-10-27,2014-10-29,ESTIMATED,,,,,,,2021-07-21,2021-07-22,ACTUAL,2015-12,ACTUAL,2015-12-31,2021-07,2021-07-31,2020-01,ACTUAL,2020-01-31,2019-06,ACTUAL,2019-06-30,,INTERVENTIONAL,MI-NSTEMI,,A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction,"A Phase 2 Prospective, Randomized, Double-blind, Sham-controlled, Parallel-group, Multi-center Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction",TERMINATED,,PHASE2,34.0,ACTUAL,Healios K.K.,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,INDUSTRY,,,,,,,2020,0.0
NCT00667823,,2008-04-24,2021-12-02,,2022-01-19,2008-04-24,2008-04-28,ESTIMATED,2022-01-19,2022-02-10,ACTUAL,,,,2022-01-19,2022-02-10,ACTUAL,2008-10-17,ACTUAL,2008-10-17,2022-01,2022-01-31,2020-12-07,ACTUAL,2020-12-07,2020-12-07,ACTUAL,2020-12-07,,INTERVENTIONAL,SERAPHIN OL,,Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension,"Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension",COMPLETED,,PHASE3,550.0,ACTUAL,Actelion,"The limitation of the open-label study design was the open label nature of the trial due to which the number of participants decreased over time to the extent that 10 percent (%) and 2.4% of participants (N=550) remained in the study at Years 7 and 9, respectively.",1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,INDUSTRY,,,,,,,2020,1.0
NCT02333149,,2014-12-16,,,2021-11-05,2015-01-05,2015-01-07,ESTIMATED,,,,,,,2021-11-05,2021-11-15,ACTUAL,2019-01-01,ACTUAL,2019-01-01,2021-11,2021-11-30,2021-11-04,ACTUAL,2021-11-04,2021-11-04,ACTUAL,2021-11-04,,INTERVENTIONAL,MYNAP,,Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population,Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population,WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Alberta,,2.0,,Issues surrounding the current COVID-19 pandemic.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,OTHER,,,,,,,2021,0.0
NCT04035564,,2019-07-23,2020-03-25,,2020-04-20,2019-07-25,2019-07-29,ACTUAL,2020-03-25,2020-04-08,ACTUAL,,,,2020-04-20,2020-04-21,ACTUAL,2018-03-30,ACTUAL,2018-03-30,2020-04,2020-04-30,2020-03-20,ACTUAL,2020-03-20,2020-03-02,ACTUAL,2020-03-02,,INTERVENTIONAL,,,Early Sodium Intake in Preterm Newborns,Early Sodium Intake in Preterm Newborns; Randomized Clinical Trial,COMPLETED,,PHASE4,52.0,ACTUAL,Hospital del Niño Dr. Federico Gomez Santos,Small numbers of subjects analyzed.,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,OTHER,,,,,,,2020,1.0
NCT03113084,,2017-03-29,,,2019-10-11,2017-04-07,2017-04-13,ACTUAL,,,,,,,2019-10-11,2019-10-14,ACTUAL,2022-08-20,ESTIMATED,2022-08-20,2019-06,2019-06-30,2023-10-10,ESTIMATED,2023-10-10,2023-04-20,ESTIMATED,2023-04-20,,INTERVENTIONAL,,,Study With Heparin Sodium in Subcutaneous Administration,Phase I Study With Pharmacodynamic Determination of Unfractionated Heparin of Porcine Origin of the Company União Química of Subcutaneous Use in Healthy Participants,SUSPENDED,,PHASE1,38.0,ESTIMATED,União Química Farmacêutica Nacional S/A,,2.0,,Delay in the R\&D stage,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,INDUSTRY,,,,,,,2023,0.0
NCT04860817,,2021-04-22,,,2022-11-23,2021-04-25,2021-04-27,ACTUAL,,,,,,,2022-11-23,2022-11-29,ACTUAL,2021-12-01,ESTIMATED,2021-12-01,2022-11,2022-11-30,2023-11-01,ESTIMATED,2023-11-01,2023-04-30,ESTIMATED,2023-04-30,,INTERVENTIONAL,,,A Study of Anti-CD7 CAR-T Cells in Pediatric and Young Adult Patients With Relapse and Refractory T-ALL/ T-LBL,Investigating the Safety and Efficacy of Anti-CD7 CAR-T Cell Immunotherapy in Patients With Relapse and Refractory T-cell Acute Lymphoblastic Leukemia or T Lymphoblastic Lymphoma,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,920th Hospital of Joint Logistics Support Force of People's Liberation Army of China,,1.0,,No proper participant is found.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,OTHER,,,,,,,2023,0.0
NCT03479203,,2018-02-28,2023-08-14,,2024-04-15,2018-03-23,2018-03-27,ACTUAL,2024-04-15,2024-05-08,ACTUAL,,,,2024-04-15,2024-05-08,ACTUAL,2018-05-22,ACTUAL,2018-05-22,2024-04,2024-04-30,2022-08-31,ACTUAL,2022-08-31,2022-08-31,ACTUAL,2022-08-31,,INTERVENTIONAL,,Pre-intervention status (i.e. pre-vaping).,Acute Effects of E-Cigarette Aerosol Inhalation,Acute and Long-term Effects of E-Cigarette Aerosol Inhalation on Biomarkers of Endothelial Function and Vascular Reactivity,COMPLETED,,EARLY_PHASE1,31.0,ACTUAL,University of Pennsylvania,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,OTHER,,,,,,,2022,1.0
NCT05458102,,2022-07-11,,,2023-11-13,2022-07-11,2022-07-14,ACTUAL,,,,,,,2023-11-13,2023-11-15,ACTUAL,2022-08-19,ACTUAL,2022-08-19,2023-11,2023-11-30,2023-10-13,ACTUAL,2023-10-13,2023-10-13,ACTUAL,2023-10-13,,INTERVENTIONAL,,,Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels,"A Phase 1, Open-label, Multicohort Study to Evaluate the Impact of Inhibitors and Inducers of Cytochrome P450 Enzyme (CYP)3A, P-glycoprotein (P-gp), and Breast Cancer Resistant Protein (BCRP) on the Pharmacokinetics (PK) of Vesatolimod (VES) in Virologically Suppressed Adults With HIV-1 on Antiretroviral Therapy (ART)",TERMINATED,,PHASE1,18.0,ACTUAL,Gilead Sciences,,2.0,,Sponsor's decision to change the clinical development plan of this molecule. This decision is not based on efficacy or safety concerns.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,INDUSTRY,,,,,,,2023,0.0
NCT02626130,,2015-12-04,,,2022-07-06,2015-12-09,2015-12-10,ESTIMATED,,,,,,,2022-07-06,2022-07-07,ACTUAL,2016-03-30,ACTUAL,2016-03-30,2022-07,2022-07-31,2022-06-20,ACTUAL,2022-06-20,2022-06-20,ACTUAL,2022-06-20,,INTERVENTIONAL,,,Tremelimumab With or Without Cryoablation in Treating Patients With Metastatic Kidney Cancer,A Pilot Study of Tremelimumab With or Without Tissue Cryoablation in Patients With Metastatic Renal Cell Carcinoma,COMPLETED,,EARLY_PHASE1,29.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,OTHER,,,,,,,2022,1.0
NCT05330429,,2022-04-08,,,2024-07-22,2022-04-08,2022-04-15,ACTUAL,,,,,,,2024-07-22,2024-07-23,ACTUAL,2022-07-08,ACTUAL,2022-07-08,2024-07,2024-07-31,2024-06-26,ACTUAL,2024-06-26,2024-06-26,ACTUAL,2024-06-26,,INTERVENTIONAL,ELEVATE CRC,,Study of Magrolimab Given Together With FOLFIRI/BEV in Patients With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC),"A Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Bevacizumab and FOLFIRI Versus Bevacizumab and FOLFIRI in Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)",TERMINATED,,PHASE2,77.0,ACTUAL,Gilead Sciences,,3.0,,Sponsor decision to terminate study,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,INDUSTRY,,,,,,,2024,0.0
NCT03125902,,2017-04-20,2020-11-10,,2024-03-01,2017-04-20,2017-04-24,ACTUAL,2020-12-09,2021-01-07,ACTUAL,,,,2024-03-01,2024-03-26,ACTUAL,2017-08-25,ACTUAL,2017-08-25,2024-03,2024-03-31,2023-01-17,ACTUAL,2023-01-17,2019-11-15,ACTUAL,2019-11-15,,INTERVENTIONAL,IMpassion131,,A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC),"A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Paclitaxel Compared With Placebo With Paclitaxel for Patients With Previously Untreated Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer",COMPLETED,,PHASE3,653.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 10:34:10.992736,2024-10-16 10:34:10.992736,INDUSTRY,,,,,,,2023,1.0
NCT02981082,,2016-11-30,2021-10-26,,2022-03-15,2016-11-30,2016-12-02,ESTIMATED,2022-03-15,2022-03-17,ACTUAL,,,,2022-03-15,2022-03-17,ACTUAL,2016-12,,2016-12-31,2022-03,2022-03-31,2020-02-10,ACTUAL,2020-02-10,2020-02-10,ACTUAL,2020-02-10,,INTERVENTIONAL,,,Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension,"A Double-blinded, Placebo-controlled Pilot Study of Dimethyl Fumarate (DMF) in Pulmonary Arterial Hypertension (PAH) Associated With Systemic Sclerosis (SSc-PAH): The Effect of DMF on Clinical Disease and Biomarkers of Oxidative Stress.",TERMINATED,,PHASE1,6.0,ACTUAL,University of Pittsburgh,Early study termination due to low recruitment; not enough participants for statistically reliable analyses.,2.0,,Low recruitment,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,OTHER,,,,,,,2020,0.0
NCT01615055,,2012-06-06,,,2018-10-10,2012-06-07,2012-06-08,ESTIMATED,,,,,,,2018-10-10,2018-10-15,ACTUAL,2018-06,ESTIMATED,2018-06-30,2018-10,2018-10-31,2020-10,ESTIMATED,2020-10-31,2020-10,ESTIMATED,2020-10-31,,INTERVENTIONAL,,,Fluoxetine Prevention Trial,"Prevention of Cognitive Decline After Chemotherapy, With Fluoxetine Treatment",WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,"University of California, Los Angeles",,2.0,,Study withdrawn. No participants enrolled.,f,,,,t,t,t,,,,,,,,,,,2024-10-15 00:35:57.742286,2024-10-15 00:35:57.742286,OTHER,,,,,,,2020,0.0
NCT05284032,,2022-03-08,,,2024-07-29,2022-03-08,2022-03-17,ACTUAL,,,,,,,2024-07-29,2024-07-31,ACTUAL,2022-11-29,ACTUAL,2022-11-29,2024-07,2024-07-31,2024-06-11,ACTUAL,2024-06-11,2024-06-11,ACTUAL,2024-06-11,,INTERVENTIONAL,,,A Pilot Trial Using Isatuximab to Overcome Platelet Transfusion Refractoriness in Human Leukocyte Antigen Allo-Immunized Patients (SuppCare 001),A Pilot Trial Using Isatuximab to Overcome Platelet Transfusion Refractoriness in Human Leukocyte Antigen Allo-Immunized Patients,TERMINATED,,EARLY_PHASE1,3.0,ACTUAL,University of Virginia,,1.0,,Slow accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,OTHER,,,,,,,2024,0.0
NCT03576963,,2018-06-21,,,2021-04-01,2018-06-21,2018-07-05,ACTUAL,,,,,,,2021-04-01,2021-04-05,ACTUAL,2020-01-30,ACTUAL,2020-01-30,2021-04,2021-04-30,2023-01-30,ESTIMATED,2023-01-30,2022-01-30,ESTIMATED,2022-01-30,,INTERVENTIONAL,,,Guadecitabine and Nivolumab in Treating Refractory Metastatic Colorectal Cancer,A Phase Ib/II Study of Guadecitabine (SGI-110) Plus Nivolumab in Refractory CIMP+ Metastatic Colorectal Cancer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Southern California,,1.0,,No funding,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,OTHER,,,,,,,2023,0.0
NCT04844749,,2021-04-09,,,2024-02-02,2021-04-13,2021-04-14,ACTUAL,,,,,,,2024-02-02,2024-02-05,ACTUAL,2021-06-24,ACTUAL,2021-06-24,2024-02,2024-02-29,2023-05-04,ACTUAL,2023-05-04,2023-05-04,ACTUAL,2023-05-04,,INTERVENTIONAL,VERACITY,,Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent,"VERACITY - Randomized, Active-Controlled, Phase 3 Study of VERU-111 for the Treatment of Metastatic Castration-Resistant Prostate Cancer in Patients Who Have Failed Prior Treatment With at Least One Androgen Receptor Targeting Agent",TERMINATED,,PHASE3,105.0,ACTUAL,Veru Inc.,,2.0,,Administrative reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,INDUSTRY,,,,,,,2023,0.0
NCT04671082,,2020-12-10,,,2022-03-21,2020-12-15,2020-12-17,ACTUAL,,,,,,,2022-03-21,2022-03-22,ACTUAL,2020-12-15,ACTUAL,2020-12-15,2022-03,2022-03-31,2022-03-21,ACTUAL,2022-03-21,2021-12-13,ACTUAL,2021-12-13,,INTERVENTIONAL,RESUME-1,,Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm,"A Phase 3, 14-Day, Double-blind, Randomized, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm",COMPLETED,,PHASE3,1004.0,ACTUAL,"Neurana Pharmaceuticals, Inc.",,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,INDUSTRY,,,,,,,2022,1.0
NCT02120365,,2014-04-17,2023-03-21,,2023-08-14,2014-04-17,2014-04-22,ESTIMATED,2023-08-14,2023-08-18,ACTUAL,,,,2023-08-14,2023-08-18,ACTUAL,2019-06-01,ACTUAL,2019-06-01,2023-08,2023-08-31,2022-02-16,ACTUAL,2022-02-16,2022-02-15,ACTUAL,2022-02-15,,INTERVENTIONAL,,Non-treatment seeking heavy drinkers- This is a crossover design. Subjects each completed at least one of the three dosages for a lab day.,Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence,Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence,COMPLETED,,PHASE1/PHASE2,22.0,ACTUAL,Virginia Commonwealth University,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,OTHER,,,,,,,2022,1.0
NCT04323631,,2020-03-25,,,2020-06-28,2020-03-25,2020-03-26,ACTUAL,,,,,,,2020-06-28,2020-06-30,ACTUAL,2020-04-30,ACTUAL,2020-04-30,2020-06,2020-06-30,2020-04-30,ACTUAL,2020-04-30,2020-04-30,ACTUAL,2020-04-30,,INTERVENTIONAL,,,Hydroxychloroquine for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection or Death,Hydroxychloroquine for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection or Death,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Rambam Health Care Campus,,2.0,,Trial not started due to accumulating evidence against HCQ for COVID,f,,,,,f,f,,,,,,,,,,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,OTHER,,,,,,,2020,0.0
NCT02111577,,2014-04-09,2021-01-22,,2021-03-10,2014-04-10,2014-04-11,ESTIMATED,2021-03-10,2021-04-06,ACTUAL,,,,2021-03-10,2021-04-06,ACTUAL,2014-05-26,ACTUAL,2014-05-26,2021-03,2021-03-31,2020-01-28,ACTUAL,2020-01-28,2020-01-28,ACTUAL,2020-01-28,,INTERVENTIONAL,VIABLE,,Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer,"A Randomized, Double Blind, Multicenter, Parallel-group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men With Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy",COMPLETED,,PHASE3,1182.0,ACTUAL,Sotio Biotech Inc.,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,INDUSTRY,,,,,,,2020,1.0
NCT02485652,,2015-06-22,,,2021-01-17,2015-06-25,2015-06-30,ESTIMATED,,,,,,,2021-01-17,2021-01-22,ACTUAL,2015-08-31,ACTUAL,2015-08-31,2021-01,2021-01-31,2020-12-08,ACTUAL,2020-12-08,2020-12-08,ACTUAL,2020-12-08,,INTERVENTIONAL,,,Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung,"A Single Arm, Open-label, Phase 2 Study Evaluating the Efficacy, Safety and PK of HM61713 in Patients With T790M-positive NSCLC After Treatment With an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor",TERMINATED,,PHASE2,162.0,ACTUAL,Hanmi Pharmaceutical Company Limited,,1.0,,Study termination by the Sponsor,f,,,,t,,,,,,,,,,,,,2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,INDUSTRY,,,,,,,2020,0.0
NCT04480424,,2020-07-20,2022-05-20,,2022-10-06,2020-07-20,2020-07-21,ACTUAL,2022-10-06,2022-10-07,ACTUAL,,,,2022-10-06,2022-10-07,ACTUAL,2020-09-17,ACTUAL,2020-09-17,2022-10,2022-10-31,2021-10-25,ACTUAL,2021-10-25,2021-08-25,ACTUAL,2021-08-25,,INTERVENTIONAL,,The intent to treat (ITT) population included all participants who were randomized.,Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19),"A Multicenter, Randomized, Open-label Parallel Group Pilot Study to Evaluate Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Subjects With COVID-19 Requiring Admission to the Intensive Care Unit",COMPLETED,,PHASE2,100.0,ACTUAL,Grifols Therapeutics LLC,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,INDUSTRY,,,,,,,2021,1.0
NCT02695160,,2016-02-24,2022-04-14,,2024-02-07,2016-02-24,2016-03-01,ESTIMATED,2024-02-07,2024-07-19,ACTUAL,,,,2024-02-07,2024-07-19,ACTUAL,2016-11-15,ACTUAL,2016-11-15,2024-02,2024-02-29,2021-04-19,ACTUAL,2021-04-19,2021-04-19,ACTUAL,2021-04-19,,INTERVENTIONAL,,All subjects in this study who received any portion of the SB-FIX infusion,Ascending Dose Study of Genome Editing by Zinc Finger Nuclease Therapeutic SB-FIX in Subjects With Severe Hemophilia B,"A Phase I, Open-Label, Ascending Dose Study to Assess the Safety and Tolerability of AAV2/6 Factor IX Gene Therapy Via Zinc Finger Nuclease (ZFN) Mediated Targeted Integration of SB-FIX in Adult Subjects With Severe Hemophilia B",TERMINATED,,PHASE1,1.0,ACTUAL,Sangamo Therapeutics,"Due to the limited sample size of 1 subject, the primary and secondary endpoints could not be analyzed, and this study could not report any conclusions.",3.0,,,f,,,,t,,f,,,,,,,,,NO,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,INDUSTRY,,,,,,,2021,0.0
NCT04607655,,2020-10-19,,,2021-02-02,2020-10-23,2020-10-29,ACTUAL,,,,,,,2021-02-02,2021-02-04,ACTUAL,2021-03,ESTIMATED,2021-03-31,2020-10,2020-10-31,2022-07,ESTIMATED,2022-07-31,2022-07,ESTIMATED,2022-07-31,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GB1211 in Participants With Suspected or Confirmed Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis","GULLIVER-1 - A Randomised, Double-Blind, Placebo Controlled, Phase Ib, 12-week Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GB1211 in Participants With Suspected or Confirmed Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Galecto Biotech AB,,3.0,,Due to COVID-19 pandemic and change in the clinical development strategy for the GB1211 compound,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,INDUSTRY,,,,,,,2022,0.0
NCT03812224,,2019-01-18,2021-01-29,,2024-02-15,2019-01-18,2019-01-23,ACTUAL,2021-03-02,2021-03-04,ACTUAL,,,,2024-02-15,2024-02-21,ACTUAL,2019-04-12,ACTUAL,2019-04-12,2024-02,2024-02-29,2020-11-25,ACTUAL,2020-11-25,2020-03-16,ACTUAL,2020-03-16,,INTERVENTIONAL,,The full analysis set (FAS) included all participants who were randomized in the study.,A Controlled Trial of Erenumab in Migraine Prevention,"A Phase 3 Japanese Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention",COMPLETED,,PHASE3,261.0,ACTUAL,Amgen,,2.0,,,f,,,,f,t,f,,,t,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either~1. the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or~2. clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,INDUSTRY,,,,,,,2020,1.0
NCT03880123,,2019-03-15,,,2020-11-24,2019-03-15,2019-03-19,ACTUAL,,,,,,,2020-11-24,2020-11-27,ACTUAL,2020-11,ESTIMATED,2020-11-30,2020-11,2020-11-30,2020-11-24,ACTUAL,2020-11-24,2020-11-24,ACTUAL,2020-11-24,,INTERVENTIONAL,,,Selinexor in Combination With Ixazomib for the Treatment of Advanced Sarcoma,A Phase I Study of the Selective Inhibitor of Nuclear Export (SINE) Selinexor in Combination With the Proteasome Inhibitor Ixazomib for the Treatment of Advanced Sarcoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,Columbia University,,1.0,,"Study will not proceed, no participants enrolled.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,OTHER,,,,,,,2020,0.0
NCT02502799,,2015-07-15,2022-11-15,,2023-02-23,2015-07-16,2015-07-20,ESTIMATED,2023-02-23,2023-03-22,ACTUAL,,,,2023-02-23,2023-03-22,ACTUAL,2015-07,,2015-07-31,2022-12,2022-12-31,2021-08,ACTUAL,2021-08-31,2021-08,ACTUAL,2021-08-31,,INTERVENTIONAL,,,Intervention for Teens With ADHD and Substance Use,Intervention for Teens With ADHD and Substance Use,TERMINATED,,PHASE3,158.0,ACTUAL,Florida International University,"Enrollment in this study fell well short of the planned 300 participants, despite substantial efforts to increase enrollment over the life of the project, and the study was terminated prior to reaching the planned enrollment target. As a result, the number of participants randomized to treatment condition was insufficient to conduct planned analyses. Furthermore, of those participants randomized, many refused assigned treatments.",3.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,OTHER,,,,,,,2021,0.0
NCT04252625,,2020-01-23,,,2024-07-25,2020-01-30,2020-02-05,ACTUAL,,,,,,,2024-07-25,2024-07-29,ACTUAL,2022-11-14,ACTUAL,2022-11-14,2024-07,2024-07-31,2024-01-25,ACTUAL,2024-01-25,2023-12-27,ACTUAL,2023-12-27,,INTERVENTIONAL,Q-Urol,,"Trial of Quercetin, Bromelain, Rye Flower Pollen & Papain on Reducing Severity of Radiation-Induced Prostatitis","A Phase II Randomized Controlled Trial of a Supplement Containing Quercetin, Bromelain, Rye Flower Pollen, and Papain on Reducing the Severity of Radiation-Induced Prostatitis",TERMINATED,,PHASE2,10.0,ACTUAL,University of Utah,,2.0,,Drug Supply Issue,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,OTHER,,,,,,,2024,0.0
NCT05127525,,2021-10-19,,,2022-05-17,2021-11-18,2021-11-19,ACTUAL,,,,,,,2022-05-17,2022-05-24,ACTUAL,2021-11-15,ACTUAL,2021-11-15,2022-05,2022-05-31,2022-01-31,ACTUAL,2022-01-31,2022-01-31,ACTUAL,2022-01-31,,INTERVENTIONAL,CLEAN,,"EffiCacy, Safety and ToLErability of a Novel Ocular ANtiseptic for Ocular Use (CLEAN)","Randomized, Double-Masked, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of IRX-101 Versus 5% Povidone-Iodine as an Ocular Surface Sterilizer",TERMINATED,,PHASE3,5.0,ACTUAL,"iRenix Medical, Inc.",,2.0,,Adverse event,,,,,f,t,f,,,,,,,,,NO,,2024-10-15 14:30:53.16053,2024-10-15 14:30:53.16053,INDUSTRY,,,,,,,2022,0.0
NCT05060003,,2021-09-16,2024-01-18,,2024-02-14,2021-09-16,2021-09-28,ACTUAL,2024-02-13,2024-02-15,ACTUAL,,,,2024-02-14,2024-02-20,ACTUAL,2022-11-08,ACTUAL,2022-11-08,2024-02,2024-02-29,2023-11-27,ACTUAL,2023-11-27,2023-11-27,ACTUAL,2023-11-27,,INTERVENTIONAL,,,Tiragolumab Plus Atezolizumab Versus Atezolizumab in the Treatment of Stage II Melanoma Patients Who Are ctDNA-positive Following Resection,A Phase II Randomized Study of Tiragolumab Plus Atezolizumab Versus Atezolizumab in the Treatment of Stage II Melanoma Patients Who Are ctDNA-positive Following Resection,TERMINATED,,PHASE2,7.0,ACTUAL,Washington University School of Medicine,,2.0,,Sponsor made decision to terminate study.,f,,,,t,t,t,t,,f,,,,,,NO,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,OTHER,,,,,,,2023,0.0
NCT05237713,,2022-01-21,,,2024-05-03,2022-02-02,2022-02-14,ACTUAL,,,,,,,2024-05-03,2024-05-06,ACTUAL,2022-04-26,ACTUAL,2022-04-26,2024-05,2024-05-31,2024-02-29,ACTUAL,2024-02-29,2024-02-29,ACTUAL,2024-02-29,,INTERVENTIONAL,,,Efficacy and Safety of Canakinumab for the Treatment of Anemia in LR-MDS Patients,"A Phase II, Single-Arm, Open-Label Study to Assess the Efficacy and Safety of Canakinumab for the Treatment of Anemia in Patients With IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes or MDS/MPN",TERMINATED,,PHASE2,10.0,ACTUAL,University of Leipzig,,1.0,,Slow recruitment. It is not considered likely that the CANFIRE trial will be able to reach the target number of patients. Clinical responders will be further treated within the trial (expected duration: 3 years after stop of enrollment).,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,OTHER,,,,,,,2024,0.0
NCT05550363,,2022-09-16,,,2024-04-02,2022-09-19,2022-09-22,ACTUAL,,,,,,,2024-04-02,2024-04-03,ACTUAL,2022-09,ESTIMATED,2022-09-30,2022-09,2022-09-30,2023-09,ESTIMATED,2023-09-30,2023-09,ESTIMATED,2023-09-30,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery (2),"A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery",WITHDRAWN,,PHASE3,0.0,ACTUAL,"EyePoint Pharmaceuticals, Inc.",,2.0,,Not currently pursuing indication,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,INDUSTRY,,,,,,,2023,0.0
NCT03436693,,2018-02-01,2023-03-30,,2024-01-28,2018-02-12,2018-02-19,ACTUAL,2024-01-28,2024-07-15,ACTUAL,,,,2024-01-28,2024-07-15,ACTUAL,2018-02-15,ACTUAL,2018-02-15,2024-01,2024-01-31,2021-01-21,ACTUAL,2021-01-21,2021-01-21,ACTUAL,2021-01-21,,INTERVENTIONAL,,,Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy,"A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy",COMPLETED,,PHASE3,308.0,ACTUAL,Mitsubishi Tanabe Pharma Corporation,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,INDUSTRY,,,,,,,2021,1.0
NCT03745690,,2018-11-15,,,2022-03-02,2018-11-15,2018-11-19,ACTUAL,,,,,,,2022-03-02,2022-03-17,ACTUAL,2018-12-12,ACTUAL,2018-12-12,2022-03,2022-03-31,2021-06-08,ESTIMATED,2021-06-08,2021-06-08,ESTIMATED,2021-06-08,,INTERVENTIONAL,,,Near-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer,"Phase 1B/2, Open-Label Study Evaluating Safety and Efficacy of Enhanced Permeability and Retention Effect for Near-Infrared Image Guided Surgical Resection of Head and Neck Cancers With Indocyanine Green",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Jonsson Comprehensive Cancer Center,,1.0,,no enrollment,,,,,t,t,f,,,t,,,,,,,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,OTHER,,,,,,,2021,0.0
NCT05444569,,2022-06-30,,,2023-02-28,2022-06-30,2022-07-06,ACTUAL,,,,,,,2023-02-28,2023-03-01,ACTUAL,2022-08-08,ACTUAL,2022-08-08,2023-02,2023-02-28,2023-02-24,ACTUAL,2023-02-24,2023-02-24,ACTUAL,2023-02-24,,INTERVENTIONAL,,,A Study of LY3537021 in Healthy Participants,"A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of LY3537021 When Combined With GLP-1 Receptor Agonist in Healthy Participants",COMPLETED,,PHASE1,47.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,INDUSTRY,,,,,,,2023,1.0
NCT03301896,,2017-09-29,,,2024-06-17,2017-09-29,2017-10-04,ACTUAL,,,,,,,2024-06-17,2024-06-20,ACTUAL,2018-01-31,ACTUAL,2018-01-31,2024-06,2024-06-30,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,,Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies,"A Phase I/Ib, Open-label, Multi-center Dose-escalation and Dose-expansion Study of the Safety and Tolerability of Intra-tumorally Administered LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies",TERMINATED,,PHASE1,45.0,ACTUAL,Novartis,,2.0,,Business reasons,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,INDUSTRY,,,,,,,2022,0.0
NCT03662659,,2018-09-06,2022-04-13,2021-08-26,2024-02-12,2018-09-06,2018-09-07,ACTUAL,2022-04-13,2022-05-09,ACTUAL,2021-08-26,2021-08-31,ACTUAL,2024-02-12,2024-02-13,ACTUAL,2018-10-16,ACTUAL,2018-10-16,2024-02,2024-02-29,2024-01-18,ACTUAL,2024-01-18,2020-08-27,ACTUAL,2020-08-27,,INTERVENTIONAL,,,An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers,"A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma",COMPLETED,,PHASE2,274.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,INDUSTRY,,,,,,,2024,0.0
NCT02407990,,2015-03-26,2021-08-06,,2021-10-18,2015-03-31,2015-04-03,ESTIMATED,2021-10-18,2021-11-17,ACTUAL,,,,2021-10-18,2021-11-17,ACTUAL,2015-06-02,ACTUAL,2015-06-02,2021-10,2021-10-31,2020-08-12,ACTUAL,2020-08-12,2020-08-12,ACTUAL,2020-08-12,,INTERVENTIONAL,,,"Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors","A Phase 1A/1B, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Subjects With Advanced Tumors",COMPLETED,,PHASE1,451.0,ACTUAL,BeiGene,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,INDUSTRY,,,,,,,2020,1.0
NCT03728426,,2018-10-31,2023-01-06,,2023-02-09,2018-10-31,2018-11-02,ACTUAL,2023-02-09,2023-03-08,ACTUAL,,,,2023-02-09,2023-03-08,ACTUAL,2019-01-11,ACTUAL,2019-01-11,2023-02,2023-02-28,2022-03-28,ACTUAL,2022-03-28,2022-03-28,ACTUAL,2022-03-28,,INTERVENTIONAL,,,Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection,A Phase 2 Study of Letermovir Treatment for Patients Experiencing Refractory or Resistant Cytomegalovirus Infection or Disease With Concurrent Organ Dysfunction,COMPLETED,,PHASE2,10.0,ACTUAL,Dana-Farber Cancer Institute,This study did not reach the target number of participants needed to achieve target power and statistically reliable results. The study was closed early due to difficulty in recruiting during the COVID-19 pandemic.,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,OTHER,,,,,,,2022,1.0
NCT04097301,,2019-08-05,2021-10-04,,2021-12-20,2019-09-19,2019-09-20,ACTUAL,2021-12-20,2022-01-19,ACTUAL,,,,2021-12-20,2022-01-19,ACTUAL,2019-08-27,ACTUAL,2019-08-27,2021-12,2021-12-31,2021-06-18,ACTUAL,2021-06-18,2021-06-18,ACTUAL,2021-06-18,,INTERVENTIONAL,,"Overall, 8 patients were enrolled in the study and underwent the screening phase to evaluate the compliance to the clinical inclusion / exclusion criteria as well as the CD44v6 expression by tumor cells (Table 10).~Of the 8 enrolled patients, 2 were treated with MLM-CAR44.1 T-cell at the first dose level. Five patients were screening failures and 1 patient dropped-out before lymphocyte apheresis for fulminant disease progression.",Study of CAR T-cell Therapy in Acute Myeloid Leukemia and Multiple Myeloma,A Phase I-IIa Trial to Assess the Safety and Antitumor Activity of Autologous CD44v6 CAR T-cells in Acute Myeloid Leukemia and Multiple Myeloma Expressing CD44v6,TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,AGC Biologics S.p.A.,"The early termination of this study is due to the analysis of its feasibility, based on the low patient recruitment rate (due to the lower-than-expected proportion of myeloma and leukemia expressing the CD44v6). A further decrease in the recruitment occurred with the diffusion of the COVID-19 emergency and the availability of new drugs for the treatment of myeloma and leukemia. These reasons make impossible to foresee the conclusion of the study in a clinically relevant time frame.",1.0,,Inability to close the study in a clinically relevant time frame,f,,,,t,f,f,,,,,,,,,,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,INDUSTRY,,,,,,,2021,0.0
NCT02893332,,2016-08-24,,,2021-01-29,2016-09-07,2016-09-08,ESTIMATED,,,,,,,2021-01-29,2021-02-03,ACTUAL,2016-01-15,ACTUAL,2016-01-15,2021-01,2021-01-31,2020-08-30,ACTUAL,2020-08-30,2020-08-30,ACTUAL,2020-08-30,,INTERVENTIONAL,Sindas,,Stereotactic Body Radiation Therapy (SBRT) in Newly Diagnosed Advanced Staged Lung Adenocarcinoma (Sindas),Tyrosine-kinase Inhibitor （TKI） With or Without SBRT in Newly Diagnosed EGFRm Advanced Staged Lung Adenocarcinoma,TERMINATED,,PHASE3,200.0,ESTIMATED,Sichuan Provincial People's Hospital,,2.0,,"After interim analysis, IRB recommend termination.",f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,OTHER,,,,,,,2020,0.0
NCT03345849,,2017-11-15,2022-10-03,,2022-10-31,2017-11-15,2017-11-17,ACTUAL,2022-10-31,2022-11-23,ACTUAL,,,,2022-10-31,2022-11-23,ACTUAL,2017-12-07,ACTUAL,2017-12-07,2022-10,2022-10-31,2022-01-13,ACTUAL,2022-01-13,2021-10-15,ACTUAL,2021-10-15,,INTERVENTIONAL,U-EXCEL,Intention-to-treat (ITT) population for the 12-week double-blind induction period includes all randomized participants who received at least one dose of double-blind study drug during Part 1.,A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies",COMPLETED,,PHASE3,526.0,ACTUAL,AbbVie,,2.0,,,f,,,,t,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,INDUSTRY,,,,,,,2022,1.0
NCT04073472,,2019-08-23,,,2022-04-01,2019-08-27,2019-08-29,ACTUAL,,,,,,,2022-04-01,2022-04-05,ACTUAL,2021-06-01,ESTIMATED,2021-06-01,2022-04,2022-04-30,2023-06-01,ESTIMATED,2023-06-01,2022-06-01,ESTIMATED,2022-06-01,,INTERVENTIONAL,IPAAF,,Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in Crohn's,A Phase I Study of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Ileal Anal Anastomosis and Ileal Pouch Fistulas in the Setting of Crohn's Disease of the Pouch,WITHDRAWN,,PHASE1,0.0,ACTUAL,The Cleveland Clinic,,1.0,,This clinical trial was entered in error. Please refer to the correct entry of this study using the following link: https://clinicaltrials.gov/ct2/show/NCT04519684,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,OTHER,,,,,,,2023,0.0
NCT04684394,,2020-12-21,2022-10-04,,2022-10-04,2020-12-21,2020-12-24,ACTUAL,2022-10-04,2022-10-31,ACTUAL,,,,2022-10-04,2022-10-31,ACTUAL,2020-12-29,ACTUAL,2020-12-29,2022-03,2022-03-31,2022-02-18,ACTUAL,2022-02-18,2022-01-10,ACTUAL,2022-01-10,,INTERVENTIONAL,,The Full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug (GEM103 or sham).,A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration,"A Multicenter, Multiple-Dose Study in Neovascular Age-related Macular Degeneration (nAMD) to Evaluate the Safety, Tolerability, Pharmacodynamics, Immunogenicity, and Clinical Effect of Repeat Intravitreal (IVT) Injections of GEM103 as an Adjunct to Standard of Care Aflibercept Therapy",TERMINATED,,PHASE2,50.0,ACTUAL,"Gemini Therapeutics, Inc.",,2.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,INDUSTRY,,,,,,,2022,0.0
NCT04427306,,2020-04-07,,,2023-09-13,2020-06-09,2020-06-11,ACTUAL,,,,,,,2023-09-13,2023-09-15,ACTUAL,2020-05-21,ACTUAL,2020-05-21,2023-09,2023-09-30,2024-05-21,ESTIMATED,2024-05-21,2022-06-27,ACTUAL,2022-06-27,,INTERVENTIONAL,,,Neoadjuvant T-VEC in High Risk Early Melanoma,Biomarker Analysis of Neoadjuvant Intralesional Therapy in High Risk Early Melanoma,SUSPENDED,,PHASE2,6.0,ACTUAL,"University of California, Davis",,1.0,,low enrollment,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,OTHER,,,,,,,2024,0.0
NCT02956785,,2016-10-29,,,2022-11-09,2016-11-03,2016-11-06,ESTIMATED,,,,,,,2022-11-09,2022-11-14,ACTUAL,2017-01,ACTUAL,2017-01-31,2022-11,2022-11-30,2022-11,ACTUAL,2022-11-30,2022-11,ACTUAL,2022-11-30,,INTERVENTIONAL,PRODUCT,,What After the First Propess,What After the First Propess. A Randomised Comparative Prospective Study,TERMINATED,,PHASE2,85.0,ACTUAL,South Warwickshire NHS Foundation Trust,,3.0,,Inability to recruit more women because of the COVID-19 and staffing/resources issues,f,,,,f,,,,,,,,,,,,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,OTHER,,,,,,,2022,0.0
NCT04668235,,2020-12-04,,,2022-08-10,2020-12-14,2020-12-16,ACTUAL,,,,,,,2022-08-10,2022-08-12,ACTUAL,2021-04-23,ACTUAL,2021-04-23,2022-08,2022-08-31,2022-08-10,ACTUAL,2022-08-10,2022-08-10,ACTUAL,2022-08-10,,INTERVENTIONAL,,,Study on Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected),"Evaluation of Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected): Phase III, Randomized, Double-blind, PLACEBO Controlled Trial",COMPLETED,,PHASE3,180.0,ACTUAL,HRH Pharmaceuticals Limited,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,OTHER,,,,,,,2022,1.0
NCT03783403,,2018-12-19,,,2024-09-04,2018-12-19,2018-12-21,ACTUAL,,,,,,,2024-09-04,2024-09-19,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2024-09,2024-09-30,2024-08-05,ACTUAL,2024-08-05,2024-08-05,ACTUAL,2024-08-05,,INTERVENTIONAL,,,"A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers","A Phase 1, Open-label, Dose Finding Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers",TERMINATED,,PHASE1,206.0,ACTUAL,Celgene,,3.0,,Business objectives have changed.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,INDUSTRY,,,,,,,2024,0.0
NCT05429762,,2022-06-08,,,2024-06-06,2022-06-22,2022-06-23,ACTUAL,,,,,,,2024-06-06,2024-06-07,ACTUAL,2022-10-03,ACTUAL,2022-10-03,2024-06,2024-06-30,2024-04-10,ACTUAL,2024-04-10,2023-08-01,ACTUAL,2023-08-01,,INTERVENTIONAL,TusaRav-QT,,Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors,Open-label Study Evaluating the Effect of Tusamitamab Ravtansine on the QTc Interval in Participants With Metastatic Solid Tumors,TERMINATED,,PHASE1,56.0,ACTUAL,Sanofi,,1.0,,Tusamitamab ravtansine clinical development program is discontinued as CARMEN-LC03 trial did not meet dual primary endpoint of improving progression-free survival. The decision is not related to any safety concern.,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,INDUSTRY,,,,,,,2024,0.0
NCT03814187,,2019-01-17,2024-02-09,,2024-02-09,2019-01-22,2019-01-23,ACTUAL,2024-02-09,2024-03-06,ACTUAL,,,,2024-02-09,2024-03-06,ACTUAL,2019-04-16,ACTUAL,2019-04-16,2024-02,2024-02-29,2023-02-13,ACTUAL,2023-02-13,2023-02-13,ACTUAL,2023-02-13,,INTERVENTIONAL,ORION-8,"Demographic and baseline characteristics are based on the safety population, as primary and secondary analysis are based on the safety population.~The safety population consisted of all ORION-3 rollover subjects who signed the informed consent to Study ORION-8, and all ORION-9/ORION-10/ORION-11 rollover subjects with at least one study drug administration in Study ORION-8",Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C,An Open-label Extension Trial of the Phase III Lipid-lowering Trials to Assess the Effect of Long Term Dosing of Inclisiran Given as Subcutaneous Injections in Subjects With High Cardiovascular Risk and Elevated LDL-C,COMPLETED,,PHASE3,3275.0,ACTUAL,Novartis,,1.0,,,f,,,,t,t,f,,,,,,,,,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,INDUSTRY,,,,,,,2023,1.0
NCT03730077,,2018-10-31,,,2021-03-15,2018-11-02,2018-11-05,ACTUAL,,,,,,,2021-03-15,2021-03-18,ACTUAL,2019-02-01,ACTUAL,2019-02-01,2021-03,2021-03-31,2021-02-18,ACTUAL,2021-02-18,2021-02-18,ACTUAL,2021-02-18,,INTERVENTIONAL,,,FMISO PET/CT Imaging Trial for Assessing Hypoxia in Soft Tissue Sarcomas,Integrated Biomarker PET/CT Imaging Trial for Assessing Hypoxia in Soft Tissue Sarcomas Using a Novel PET/CT Tracer,TERMINATED,,PHASE1,5.0,ACTUAL,University of Pennsylvania,,2.0,,PI Left Institution,f,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,OTHER,,,,,,,2021,0.0
NCT02565901,,2015-09-25,2021-06-08,,2021-09-03,2015-09-29,2015-10-01,ESTIMATED,2021-09-03,2021-10-01,ACTUAL,,,,2021-09-03,2021-10-01,ACTUAL,2016-02-29,ACTUAL,2016-02-29,2021-09,2021-09-30,2020-06-16,ACTUAL,2020-06-16,2020-06-16,ACTUAL,2020-06-16,,INTERVENTIONAL,,,"Sirolimus, Docetaxel, and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer","A Phase 1-2 Study of Sirolimus, Docetaxel and Carboplatin for Treatment of Patients With Metastatic, Castration Resistant Prostate Cancer: (Rapamycin Inhibition of DDSP [RID])",TERMINATED,,PHASE1/PHASE2,28.0,ACTUAL,University of Washington,,2.0,,Terminated due to insufficient funding,f,,,,f,t,f,,,,,,,,,,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,OTHER,,,,,,,2020,0.0
NCT03988920,,2019-06-14,2023-03-03,,2023-03-03,2019-06-14,2019-06-18,ACTUAL,2023-03-03,2023-03-29,ACTUAL,,,,2023-03-03,2023-03-29,ACTUAL,2019-06-15,ACTUAL,2019-06-15,2023-03,2023-03-31,2021-07-31,ACTUAL,2021-07-31,2021-06-26,ACTUAL,2021-06-26,,INTERVENTIONAL,NORMALIZE,,A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP,"A Long-Term, Open Label Study to Evaluate the Ability of Tenapanor Alone or in Combination With Sevelamer to Treat to Goal Serum Phosphorus in Patients With End-Stage Kidney Disease on Dialysis (NORMALIZE)",COMPLETED,,PHASE4,172.0,ACTUAL,Ardelyx,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,INDUSTRY,,,,,,,2021,1.0
NCT05525572,,2022-04-13,,,2024-08-08,2022-08-30,2022-09-01,ACTUAL,,,,,,,2024-08-08,2024-08-12,ACTUAL,2024-02-12,ACTUAL,2024-02-12,2024-08,2024-08-31,2024-08-02,ACTUAL,2024-08-02,2024-08-02,ACTUAL,2024-08-02,,INTERVENTIONAL,COCKTAIL-DM,,Combining Shockwave Therapy and Platelet Rich Plasma to Treat Erectile Dysfunction in Diabetic Men (COCKTAIL-DM),Combining Shockwave Therapy and Platelet Rich Plasma to Treat Erectile Dysfunction in Diabetic Men (COCKTAIL-DM),TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,University of Miami,,1.0,,Funding ended,f,,,,t,t,t,,,f,,,,,,NO,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,OTHER,,,,,,,2024,0.0
NCT05643170,,2022-11-22,2024-05-03,,2024-06-11,2022-12-01,2022-12-08,ACTUAL,2024-06-11,2024-06-12,ACTUAL,,,,2024-06-11,2024-06-12,ACTUAL,2022-11-08,ACTUAL,2022-11-08,2023-07,2023-07-31,2023-03-08,ACTUAL,2023-03-08,2023-03-01,ACTUAL,2023-03-01,,INTERVENTIONAL,PENNANT,,"An Open-label Study to Assess the Long-term Safety, Tolerability, Effectiveness, and Durability of Effect of KarXT in Patients With DSM-5 Diagnosis of Schizophrenia","A Multi-center, Open-label Study to Assess the Effectiveness, Long-term Safety, Tolerability, and Durability of Effect of KarXT in Patients With DSM-5 Diagnosis of Schizophrenia",TERMINATED,,PHASE3,4.0,ACTUAL,Karuna Therapeutics,,1.0,,Company's business decision.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,INDUSTRY,,,,,,,2023,0.0
NCT02545933,,2015-09-08,2020-08-10,,2020-09-15,2015-09-09,2015-09-10,ESTIMATED,2020-08-10,2020-08-25,ACTUAL,,,,2020-09-15,2020-09-16,ACTUAL,2016-02,ACTUAL,2016-02-29,2020-09,2020-09-30,2020-01,ACTUAL,2020-01-31,2019-05,ACTUAL,2019-05-31,,INTERVENTIONAL,VORA-PRATIC,,Vorapaxar in Patients With Prior Myocardial Infarction Treated With Prasugrel and Ticagrelor,"Adjunctive Vorapaxar Therapy in Patients With Prior Myocardial Infarction Treated With New Generation P2Y12 Receptor Inhibitors Prasugrel and Ticagrelor (VORA-PRATIC): A Prospective, Randomized, Pharmacodynamic Study",COMPLETED,,PHASE4,130.0,ACTUAL,University of Florida,,3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,OTHER,,,,,,,2020,1.0
NCT04278937,,2020-02-19,,,2020-06-13,2020-02-19,2020-02-20,ACTUAL,,,,,,,2020-06-13,2020-06-16,ACTUAL,2019-04-15,ACTUAL,2019-04-15,2020-06,2020-06-30,2020-04-15,ACTUAL,2020-04-15,2020-02-15,ACTUAL,2020-02-15,,INTERVENTIONAL,,,Antenatal Azithromycin to Prevent Preterm Birth in Pregnant Women With Vaginal Cerclage,Antenatal Azithromycin to Prevent Preterm Birth in Pregnant Women With Vaginal Cerclage. A Randomized Controlled Trial,COMPLETED,,PHASE4,50.0,ACTUAL,Ain Shams Maternity Hospital,,2.0,,,f,,,,f,f,f,,,f,,,,,,,,2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,OTHER,,,,,,,2020,1.0
NCT03245255,,2017-08-04,2021-12-15,,2024-05-01,2017-08-07,2017-08-10,ACTUAL,2024-05-01,2024-05-29,ACTUAL,,,,2024-05-01,2024-05-29,ACTUAL,2017-12-04,ACTUAL,2017-12-04,2024-05,2024-05-31,2023-06-07,ACTUAL,2023-06-07,2020-09-18,ACTUAL,2020-09-18,,INTERVENTIONAL,,,Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound,Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound,COMPLETED,,PHASE2,80.0,ACTUAL,Thomas Jefferson University,,1.0,,,f,,,,f,t,f,,,,,,2018-08-01 (anticipated) or starting 6 months after publication,Accessible research platform,,YES,"This project will generate pressure values in the aorta, and left and right ventricles using the proposed research method (i.e., SHAPE) and using the standard of care (i.e., catheter based pressure values). Additionally peripheral and central pressures will be generated. All of the pressure values will be made available. Further, all ultrasound data obtained for SHAPE measurements will be made available after anonymizing the data-set to remove any patient information",2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,OTHER,,,,,,,2023,1.0
NCT03184584,,2017-06-09,,,2020-10-30,2017-06-09,2017-06-12,ACTUAL,,,,,,,2020-10-30,2020-11-03,ACTUAL,2017-10-09,ACTUAL,2017-10-09,2020-10,2020-10-31,2020-05-08,ACTUAL,2020-05-08,2020-05-08,ACTUAL,2020-05-08,,INTERVENTIONAL,,,Open-Label Rollover Study of PBI 4050 in Subjects With Alström Syndrome,An Open-Label Rollover Study of PBI 4050 in Subjects With Alström Syndrome,TERMINATED,,PHASE2/PHASE3,10.0,ACTUAL,Liminal BioSciences Ltd.,,1.0,,Terminated early due to redeployment of study site staff during Covid-19 pandemic,f,,,,t,f,f,,,,,,,,,,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,INDUSTRY,,,,,,,2020,0.0
NCT03265951,,2017-08-25,,,2021-04-08,2017-08-25,2017-08-29,ACTUAL,,,,,,,2021-04-08,2021-04-09,ACTUAL,2018-01-01,ACTUAL,2018-01-01,2020-10,2020-10-31,2020-06-30,ACTUAL,2020-06-30,2019-09-30,ACTUAL,2019-09-30,,INTERVENTIONAL,DORMI,,Ramelteon for Complex Insomnia in Veterans With PTSD,"A Pilot, Randomized, Double-blind, Placebo Controlled, Trial of Ramelteon for CPAP Non-Adherent Veterans With PTSD and Complex Insomnia",WITHDRAWN,,PHASE4,0.0,ACTUAL,State University of New York at Buffalo,,2.0,,Lack of response,f,,,,f,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,OTHER,,,,,,,2020,0.0
NCT02667587,,2016-01-26,2021-11-30,,2024-05-10,2016-01-26,2016-01-29,ESTIMATED,2022-01-06,2022-02-03,ACTUAL,,,,2024-05-10,2024-05-29,ACTUAL,2016-05-09,ACTUAL,2016-05-09,2024-05,2024-05-31,2024-04-09,ACTUAL,2024-04-09,2020-12-22,ACTUAL,2020-12-22,,INTERVENTIONAL,CheckMate548,Demographic characteristics are based off all randomized participants,"An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)",A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma,COMPLETED,,PHASE3,716.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,t,,,,t,t,f,,,,,,,,,,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,INDUSTRY,,NCT02475382,NO_LONGER_AVAILABLE,,,,2024,1.0
NCT03526536,,2018-05-03,,,2020-10-22,2018-05-03,2018-05-16,ACTUAL,,,,,,,2020-10-22,2020-10-26,ACTUAL,2018-05-01,ACTUAL,2018-05-01,2020-10,2020-10-31,2020-09-03,ACTUAL,2020-09-03,2020-09-03,ACTUAL,2020-09-03,,INTERVENTIONAL,,,Pilot: Insulin Sensitivity/Management in Hyperglycemic Patients in Perioperative Period ESRD/Non-ESRD,A Comparison of Insulin Sensitivity and Management in Hyperglycemic Patients in the Perioperative Period: ESRD vs. Non-ESRD,TERMINATED,,PHASE4,40.0,ACTUAL,State University of New York - Downstate Medical Center,,2.0,,The study required more participants than anticipated for statistical significance.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 22:01:28.305593,2024-10-16 22:01:28.305593,OTHER,,,,,,,2020,0.0
NCT02822144,,2016-06-27,,,2023-05-19,2016-06-29,2016-07-04,ESTIMATED,,,,,,,2023-05-19,2023-05-23,ACTUAL,2016-09-29,ACTUAL,2016-09-29,2023-05,2023-05-31,2020-08,ACTUAL,2020-08-31,2020-08,ACTUAL,2020-08-31,,INTERVENTIONAL,GASS,,General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke,General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke,COMPLETED,,PHASE3,351.0,ACTUAL,Rennes University Hospital,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,OTHER,,,,,,,2020,1.0
NCT05061537,,2021-09-22,2023-10-09,,2023-10-09,2021-09-22,2021-09-29,ACTUAL,2023-10-09,2024-04-12,ACTUAL,,,,2023-10-09,2024-04-12,ACTUAL,2021-10-20,ACTUAL,2021-10-20,2023-10,2023-10-31,2022-10-14,ACTUAL,2022-10-14,2022-10-14,ACTUAL,2022-10-14,,INTERVENTIONAL,,Safety analysis set included all enrolled participants who received at least one dose of study intervention. Data was not collected for Part 1B and Part 2 as no participants were enrolled due to early termination.,Study of PF-07263689 in Participants With Selected Advanced Solid Tumors,"A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY AND PHARMACODYNAMICS OF PF-07263689, EITHER ALONE OR IN COMBINATION WITH AN ANTI-PD-1 ANTIBODY, IN PREVIOUSLY TREATED PARTICIPANTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC SOLID TUMORS",TERMINATED,,PHASE1,13.0,ACTUAL,Pfizer,Data was not collected for Part 1B and Part 2 as no participants were enrolled due to early termination.,5.0,,The study was terminated by the Sponsor due to business decision and not due to any safety concerns with PF-07263689. There are no changes to the risk-benefit for participants who have received PF-07263689 in the study.,f,,,,,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,INDUSTRY,,,,,,,2022,0.0
NCT03682705,,2018-09-21,2021-03-04,,2021-04-06,2018-09-21,2018-09-25,ACTUAL,2021-04-06,2021-05-03,ACTUAL,,,,2021-04-06,2021-05-03,ACTUAL,2018-10-08,ACTUAL,2018-10-08,2021-04,2021-04-30,2020-03-26,ACTUAL,2020-03-26,2020-03-26,ACTUAL,2020-03-26,,INTERVENTIONAL,,Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug,A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis,Rheumatoid Arthritis: A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599 Combination) With a Background of Conventional Synthetic DMARDs in Subjects With Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs,COMPLETED,,PHASE2,242.0,ACTUAL,AbbVie,,6.0,,,f,,,,t,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,INDUSTRY,,,,,,,2020,1.0
NCT03520946,,2018-04-17,,,2024-08-08,2018-04-27,2018-05-11,ACTUAL,,,,,,,2024-08-08,2024-08-09,ACTUAL,2019-01-24,ACTUAL,2019-01-24,2024-08,2024-08-31,2024-07-30,ACTUAL,2024-07-30,2024-07-30,ACTUAL,2024-07-30,,INTERVENTIONAL,RAMTAS,,RAMucirumab in Combination Wth TAS102 vs. TAS102 Alone in Chemotherapy Refractory Metastatic Colorectal Cancer Patients,A Phase III Study of RAMucirumab in Combination With TAS102 vs. TAS102 Monotherapy in Chemotherapy Refractory Metastatic Colorectal Cancer Patients,COMPLETED,,PHASE3,430.0,ACTUAL,Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,No IPD will be shared,2024-10-16 00:57:03.935747,2024-10-16 00:57:03.935747,OTHER,,,,,,,2024,0.0
NCT04671901,,2020-12-11,2023-10-31,,2023-10-31,2020-12-11,2020-12-17,ACTUAL,2023-10-31,2023-11-18,ACTUAL,,,,2023-10-31,2023-11-18,ACTUAL,2020-12-10,ACTUAL,2020-12-10,2023-03,2023-03-31,2023-03-29,ACTUAL,2023-03-29,2023-03-29,ACTUAL,2023-03-29,,INTERVENTIONAL,,,A Study of Romiplostim to Prevent Low Platelet Counts in Children and Young Adults Receiving Chemotherapy for Solid Tumors,A Single Arm Open-Label Pilot Study of Prophylactic Romiplostim Use Compared to Benchmark Rate in the Prevention of Chemotherapy Induced Thrombocytopenia in Pediatric Solid Tumors Patients Undergoing Myelosuppressive Chemotherapy,TERMINATED,,PHASE2,2.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,Lack of accrual,,,,,,t,f,,,,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,OTHER,,,,,,,2023,0.0
NCT04928430,,2021-05-27,,,2023-01-19,2021-06-14,2021-06-16,ACTUAL,,,,,,,2023-01-19,2023-01-23,ACTUAL,2021-04-28,ACTUAL,2021-04-28,2023-01,2023-01-31,2022-11-28,ACTUAL,2022-11-28,2022-11-28,ACTUAL,2022-11-28,,INTERVENTIONAL,,,Efficacy and Safety of XAV-19 for the Treatment of Moderate-to-severe COVID-19,"An International, Placebo-controlled, Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of 150 mg XAV-19 Infusion, in Patients With Moderate to Severe COVID-19: the EUROXAV Study",TERMINATED,,PHASE2/PHASE3,290.0,ACTUAL,Xenothera SAS,,2.0,,Lack of recruitment,f,,,,t,f,f,,,,,,,,,,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2022,0.0
NCT05569031,,2022-10-03,,,2022-10-05,2022-10-05,2022-10-06,ACTUAL,,,,,,,2022-10-05,2022-10-06,ACTUAL,2019-01-01,ACTUAL,2019-01-01,2022-10,2022-10-31,2022-06-15,ACTUAL,2022-06-15,2021-12-15,ACTUAL,2021-12-15,,INTERVENTIONAL,,,Treatment of Withdrawal Symptoms and Prevention of Relapse in Patients With Tramadol Abuse,A Comparative Study of the Efficacy of Venlafaxine and Naltrexone for Relapse Prevention in Patients With Opioid Use Disorder Attributed to Tramadol,COMPLETED,,PHASE4,52.0,ACTUAL,Zagazig University,,2.0,,,f,,,,,f,f,,,f,,,,,,NO,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,OTHER_GOV,,,,,,,2022,1.0
NCT05076149,,2021-09-29,2024-05-16,,2024-05-16,2021-09-29,2021-10-13,ACTUAL,2024-05-16,2024-06-13,ACTUAL,,,,2024-05-16,2024-06-13,ACTUAL,2021-10-27,ACTUAL,2021-10-27,2024-05,2024-05-31,2023-11-30,ACTUAL,2023-11-30,2023-05-18,ACTUAL,2023-05-18,,INTERVENTIONAL,,All participants who received at least 1 dose of study drug during the treatment Period.,"A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation","A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation",COMPLETED,,PHASE3,597.0,ACTUAL,Vertex Pharmaceuticals Incorporated,,2.0,,,f,,,,,t,f,,,,,,,,,NO,Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,INDUSTRY,,,,,,,2023,1.0
NCT03736343,,2018-11-06,,,2023-11-29,2018-11-07,2018-11-09,ACTUAL,,,,,,,2023-11-29,2023-12-06,ACTUAL,2019-05-01,ACTUAL,2019-05-01,2023-11,2023-11-30,2022-10-17,ACTUAL,2022-10-17,2020-05-31,ACTUAL,2020-05-31,,INTERVENTIONAL,IDEA,,Impulsivity and Alcohol Response,Individual Differences in the Effects of Alcohol (IDEA) Study,TERMINATED,,EARLY_PHASE1,24.0,ACTUAL,University of Florida,,2.0,,"The COVID-19 outbreak began, precluding further participant recruitment for this protocol, which could only be conducted in-person. A decision was made that ample data was available to end data collection earlier than anticipated.",f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,OTHER,,,,,,,2022,0.0
NCT02716038,,2016-03-17,2023-10-01,,2023-11-21,2016-03-17,2016-03-22,ESTIMATED,2023-11-21,2023-12-12,ACTUAL,,,,2023-11-21,2023-12-12,ACTUAL,2016-06-07,ACTUAL,2016-06-07,2023-11,2023-11-30,2022-10-01,ACTUAL,2022-10-01,2022-10-01,ACTUAL,2022-10-01,,INTERVENTIONAL,,,"Neoadjuvant MPDL3280A, Nab-paclitaxel and Carboplatin (MAC) in NSCLC","A Single-arm, Phase II Study of Neoadjuvant MPDL3280A, Nab-paclitaxel and Carboplatin (MAC) in Resectable Non-small Cell Lung Cancer (NSCLC)",COMPLETED,,PHASE2,39.0,ACTUAL,Columbia University,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,OTHER,,,,,,,2022,1.0
NCT03665129,,2018-09-01,,,2022-01-12,2018-09-07,2018-09-11,ACTUAL,,,,,,,2022-01-12,2022-01-27,ACTUAL,2018-09-07,ACTUAL,2018-09-07,2022-01,2022-01-31,2021-02-24,ACTUAL,2021-02-24,2021-02-24,ACTUAL,2021-02-24,,INTERVENTIONAL,STELLAR-001,,IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors,"A Phase I Study of the Anti-C5aR, IPH5401, in Combination With the Anti-PD-L1, Durvalumab, in Patients With Selected Advanced Solid Tumors",TERMINATED,,PHASE1,73.0,ACTUAL,Innate Pharma,,4.0,,early termination,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,INDUSTRY,,,,,,,2021,0.0
NCT04533074,,2020-08-27,,,2022-03-13,2020-08-27,2020-08-31,ACTUAL,,,,,,,2022-03-13,2022-03-29,ACTUAL,2018-08-23,ACTUAL,2018-08-23,2022-03,2022-03-31,2021-03-15,ACTUAL,2021-03-15,2021-03-10,ACTUAL,2021-03-10,,INTERVENTIONAL,,,Microbiological Evaluation of Single Versus Multiple Visits Regeneration Using MALDI-TOF Mass Spectrometry,Microbiological Evaluation of Single Versus Multiple Visits Regeneration Using MALDI-TOF Mass Spectrometry (A Randomized Controlled Clinical Trial),TERMINATED,,PHASE2,16.0,ACTUAL,University of Alexandria,,2.0,,due to the COVID-19 pandemic,f,,,,,f,f,,,,,,,,,,,2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,OTHER,,,,,,,2021,0.0
NCT04026880,,2019-07-17,,,2022-07-18,2019-07-18,2019-07-19,ACTUAL,,,,,,,2022-07-18,2022-07-20,ACTUAL,2021-01-01,ESTIMATED,2021-01-01,2022-07,2022-07-31,2022-06-01,ESTIMATED,2022-06-01,2022-01-01,ESTIMATED,2022-01-01,,INTERVENTIONAL,TPELVIC,,Testosterone Effects on Pelvic Floor Muscles,A Pilot Study To Evaluate The Effect of Testosterone Enanthate On Structural and Functional Characteristics of Pelvic Floor Muscles In Postmenopausal Women With Urinary Incontinence,WITHDRAWN,,PHASE3,0.0,ACTUAL,Brigham and Women's Hospital,,2.0,,Lack of funds,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,OTHER,,,,,,,2022,0.0
NCT02419170,,2015-02-04,,,2016-07-14,2015-04-16,2015-04-17,ESTIMATED,,,,,,,2016-07-14,2016-07-18,ESTIMATED,2016-07,,2016-07-31,2016-07,2016-07-31,2023-10,ESTIMATED,2023-10-31,2019-10,ESTIMATED,2019-10-31,,INTERVENTIONAL,,,Mature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC),Mature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC),WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Washington University School of Medicine,,1.0,,Investigator who manufactured the vaccine left the university.,f,,,,f,,,,,,,,,,,,,2024-10-15 01:15:09.927277,2024-10-15 01:15:09.927277,OTHER,,,,,,,2023,0.0
NCT04611321,,2020-10-27,,,2023-03-24,2020-10-27,2020-11-02,ACTUAL,,,,,,,2023-03-24,2023-03-28,ACTUAL,2020-12-01,ACTUAL,2020-12-01,2023-03,2023-03-31,2023-03-10,ACTUAL,2023-03-10,2023-03-10,ACTUAL,2023-03-10,,INTERVENTIONAL,,,Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma,"A Phase Ib/II, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of IBI318 in Participants With Advanced Cutaneous Squamous Cell Carcinoma.",TERMINATED,,PHASE1/PHASE2,15.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,1.0,,"Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.",f,,,,t,f,f,,,,,,,,,,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2023,0.0
NCT02587598,,2015-10-26,2021-08-03,,2021-11-09,2015-10-26,2015-10-27,ESTIMATED,2021-11-09,2021-12-08,ACTUAL,,,,2021-11-09,2021-12-08,ACTUAL,2015-12-29,ACTUAL,2015-12-29,2021-11,2021-11-30,2020-08-11,ACTUAL,2020-08-11,2020-08-11,ACTUAL,2020-08-11,,INTERVENTIONAL,,,Study of INCB053914 in Subjects With Advanced Malignancies,A Phase 1/2 Study of INCB053914 in Subjects With Advanced Malignancies,TERMINATED,,PHASE1/PHASE2,97.0,ACTUAL,Incyte Corporation,,9.0,,,t,,,,f,,f,,,,,,,,,,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,INDUSTRY,,NCT03147742,APPROVED_FOR_MARKETING,,,,2020,0.0
NCT03324880,,2017-10-10,2023-05-03,,2023-05-12,2017-10-24,2017-10-30,ACTUAL,2023-05-12,2023-06-09,ACTUAL,,,,2023-05-12,2023-06-09,ACTUAL,2018-01-24,ACTUAL,2018-01-24,2023-05,2023-05-31,2022-05-19,ACTUAL,2022-05-19,2022-05-19,ACTUAL,2022-05-19,,INTERVENTIONAL,,Safety Analysis Set included all participants in the Intention-to-Treat (ITT) Set who took at least 1 dose of investigational product (study drug or placebo).,A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE),"A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)]",COMPLETED,,PHASE4,93.0,ACTUAL,Takeda,,2.0,,,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,INDUSTRY,,,,,,,2022,1.0
NCT05808881,,2023-03-15,,,2023-07-10,2023-03-30,2023-04-12,ACTUAL,,,,,,,2023-07-10,2023-07-12,ACTUAL,2023-06,ESTIMATED,2023-06-30,2023-07,2023-07-31,2024-05,ESTIMATED,2024-05-31,2024-05,ESTIMATED,2024-05-31,,INTERVENTIONAL,COINED,,Clinical Outcomes From Nalmefene,Clinical Outcomes From Injectable Nalmefene in the Emergency Department (COINED),WITHDRAWN,,PHASE4,0.0,ACTUAL,Purdue Pharma LP,,2.0,,Due to changes in research objectives and methodological approach.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2024,0.0
NCT04095689,,2019-09-18,,,2024-02-19,2019-09-18,2019-09-19,ACTUAL,,,,,,,2024-02-19,2024-02-21,ACTUAL,2021-03-17,ACTUAL,2021-03-17,2024-02,2024-02-29,2024-12,ESTIMATED,2024-12-31,2024-06,ESTIMATED,2024-06-30,,INTERVENTIONAL,INTEGRAL,,Docetaxel Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy in Triple Negative Breast Cancer,Phase II Study of Docetaxel Chemotherapy With Pembrolizumab and Interleukin-12 Gene Therapy in Patients With Anthracycline- Refractory Triple Negative Breast Cancer (INTEGRAL),SUSPENDED,,PHASE2,30.0,ESTIMATED,The Methodist Hospital Research Institute,,1.0,,"Stopping rules met per protocol, comprehensive review needed prior to enrolling again",f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,OTHER,,,,,,,2024,0.0
NCT05362474,,2022-04-21,,,2024-04-01,2022-05-02,2022-05-05,ACTUAL,,,,,,,2024-04-01,2024-04-02,ACTUAL,2022-07-01,ACTUAL,2022-07-01,2024-04,2024-04-30,2023-06-20,ACTUAL,2023-06-20,2023-06-20,ACTUAL,2023-06-20,,INTERVENTIONAL,,,Targeting Leukotrienes in Kidney Disease,Targeting Leukotrienes in Kidney Disease: A Pilot Study,TERMINATED,,PHASE3,5.0,ACTUAL,"University of Colorado, Denver",,1.0,,Funding not available,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,OTHER,,,,,,,2023,0.0
NCT01866111,,2013-05-28,2020-08-20,2016-10-12,2022-04-04,2013-05-28,2013-05-31,ESTIMATED,2022-04-04,2022-04-29,ACTUAL,2016-10-12,2016-10-13,ESTIMATED,2022-04-04,2022-04-29,ACTUAL,2013-07-31,ACTUAL,2013-07-31,2022-04,2022-04-30,2021-10-31,ACTUAL,2021-10-31,2021-04-05,ACTUAL,2021-04-05,,INTERVENTIONAL,,"Overall number of baseline participants includes all randomized pts, 437. Baseline analysis population includes all randomized pts who took at least 1 dose of study drug with any post-baseline seizure data (434): Pbo (n=106), Cnb: 100mg (n=108), 200mg (n=109), 400mg (n=111). Baseline seizure frequency and enrollment region used analysis population.","A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures","A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension",COMPLETED,,PHASE2,437.0,ACTUAL,"SK Life Science, Inc.",,4.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,INDUSTRY,,,,,,,2021,1.0
NCT03704584,,2018-10-10,2022-08-04,2022-01-24,2022-09-14,2018-10-10,2018-10-15,ACTUAL,2022-09-14,2022-10-12,ACTUAL,2022-09-14,2022-10-12,ACTUAL,2022-09-14,2022-10-12,ACTUAL,2019-05-14,ACTUAL,2019-05-14,2022-09,2022-09-30,2020-01-14,ACTUAL,2020-01-14,2020-01-14,ACTUAL,2020-01-14,,INTERVENTIONAL,,"62 individuals were consented to participate, and 74 digits were randomized and injected as a part of this study. One individual with one digit withdrew from the study after injection. 61 individuals completed the study, and 73 digits are available for analysis.",Corticosteroid(CS) + Lido or Corticosteroid(CS) Alone,"Corticosteroid(CS) Injections for the Treatment of Common Upper Extremity Pathologies, With or Without Lidocaine",TERMINATED,,PHASE4,62.0,ACTUAL,Emory University,,2.0,,Enrollment and study activities were initially suspended due to COVID-19. The investigator has also left Emory and the study will not resume.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,OTHER,,,,,Digits,,2020,0.0
NCT03536754,,2018-03-28,2023-08-17,,2023-12-04,2018-05-23,2018-05-25,ACTUAL,2023-12-04,2023-12-05,ACTUAL,,,,2023-12-04,2023-12-05,ACTUAL,2018-05-17,ACTUAL,2018-05-17,2023-11,2023-11-30,2020-02-19,ACTUAL,2020-02-19,2020-02-19,ACTUAL,2020-02-19,,INTERVENTIONAL,,,A Study of CCX140-B in Subjects With FSGS,"A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Focal Segmental Glomerulosclerosis (FSGS)",COMPLETED,,PHASE2,46.0,ACTUAL,ChemoCentryx,Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.,4.0,,,,,,,t,t,f,,,,,,,,,,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2020,1.0
NCT02013141,,2013-12-11,2023-04-05,,2024-01-12,2013-12-16,2013-12-17,ESTIMATED,2024-01-12,2024-06-24,ACTUAL,,,,2024-01-12,2024-06-24,ACTUAL,2014-12,ACTUAL,2014-12-31,2024-01,2024-01-31,2021-03,ACTUAL,2021-03-31,2021-03,ACTUAL,2021-03-31,,INTERVENTIONAL,,,Telavancin Pediatric PK Study (Ages >12 Months to 17 Years),An Open-Label Study of the Pharmacokinetics of a Single Dose of Telavancin in Pediatric Subjects Aged 12 Months to 17 Years,TERMINATED,,PHASE1,22.0,ACTUAL,Cumberland Pharmaceuticals,"Information on the pharmacokinetics and safety of a single dose of telavancin in subjects aged 2 to 5 years is limited as Cohort 3 only enrolled 1 participant due to early termination of the study. No infants were enrolled due to early termination of the study, and therefore, no information is available on the pharmacokinetics and safety of a single dose of telavancin in infants.",1.0,,FDA waived the pediatric study requirement for this application,f,,,,t,,,,,,,,,,,,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,INDUSTRY,,,,,,,2021,0.0
NCT03330704,,2017-10-23,,,2020-03-17,2017-10-31,2017-11-06,ACTUAL,,,,,,,2020-03-17,2020-03-19,ACTUAL,2017-11-28,ACTUAL,2017-11-28,2019-02,2019-02-28,2020-01-01,ACTUAL,2020-01-01,2020-01-01,ACTUAL,2020-01-01,,INTERVENTIONAL,,,"Small-Volume, Patient-Specific, Balanced Hypertonic Fluid Protocol Validation",Randomized Controlled Trial for the Use of Patient Tailored Balanced Hypertonic Solutions in Patients With Cerebral Edema,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Stanford University,,2.0,,lack of eligible study participants,f,,,,f,t,f,,,f,,,,,,NO,No plan to share data,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,OTHER,,,,,,,2020,0.0
NCT03656692,,2018-08-21,2021-06-18,,2021-07-12,2018-08-30,2018-09-04,ACTUAL,2021-07-12,2021-08-03,ACTUAL,,,,2021-07-12,2021-08-03,ACTUAL,2018-10-05,ACTUAL,2018-10-05,2021-07,2021-07-31,2020-07-14,ACTUAL,2020-07-14,2020-07-14,ACTUAL,2020-07-14,,INTERVENTIONAL,,Modified Intent to Treat population included all participants who received at least one dose of study treatment.,Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer),"A Multicenter, Open Label Pilot Study to Explore the Efficacy and Safety of Acthar Gel in Subjects With Severe Noninfectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis (NIPPU)",TERMINATED,,PHASE4,5.0,ACTUAL,Mallinckrodt,,1.0,,Logistical challenges; no safety concerns,f,,,,f,t,f,,,t,,,,,,NO,Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03656692) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,INDUSTRY,,,,,,,2020,0.0
NCT04665115,,2020-12-10,,,2022-08-02,2020-12-10,2020-12-11,ACTUAL,,,,,,,2022-08-02,2022-08-03,ACTUAL,2020-11-23,ACTUAL,2020-11-23,2022-08,2022-08-31,2022-07-22,ACTUAL,2022-07-22,2021-11-19,ACTUAL,2021-11-19,,INTERVENTIONAL,,,Ibrutinib for the Treatment of Patients With B-Cell Malignancies Who Are Infected With Coronavirus Disease 2019 (COVID-19),A Prospective Study of Patients With B-Cell Hematologic Malignancies on Ibrutinib Therapy Who Are Infected With Coronavirus Disease 2019 (COVID-19),WITHDRAWN,,PHASE2,0.0,ACTUAL,Academic and Community Cancer Research United,,3.0,,"Permanently closed 11/19/201. The widespread availability of COVID vaccination, the projected decline in infection rates, and the increasing use of non-ibrutinib containing BTKi therapy, we have not been able to get support for this study",f,,,,f,t,f,,,f,,,,,,,,2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,OTHER,,,,,,,2022,0.0
NCT04461483,,2020-07-03,2021-11-10,,2021-11-10,2020-07-03,2020-07-08,ACTUAL,2021-11-10,2022-01-11,ACTUAL,,,,2021-11-10,2022-01-11,ACTUAL,2020-08-13,ACTUAL,2020-08-13,2020-11,2020-11-30,2020-11-14,ACTUAL,2020-11-14,2020-11-14,ACTUAL,2020-11-14,,INTERVENTIONAL,,The safety analysis set included all participants who received at least 1 dose of study drug.,"A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Doses With Titration of TAK-935 in Healthy Japanese Participants","A Randomized, Double-blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Doses With Titration of TAK-935 in Healthy Japanese Subjects",COMPLETED,,PHASE1,33.0,ACTUAL,Takeda,,8.0,,,f,,,,f,f,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2020,0.0
NCT03024944,,2017-01-17,,,2017-12-27,2017-01-17,2017-01-19,ESTIMATED,,,,,,,2017-12-27,2017-12-29,ACTUAL,2017-12,ESTIMATED,2017-12-31,2017-12,2017-12-31,2020-01,ESTIMATED,2020-01-31,2019-01,ESTIMATED,2019-01-31,,INTERVENTIONAL,TAUPET,,TAU PET Imaging in Northern Manhattan Study of Metabolism and Mind,TAU PET Imaging in Northern Manhattan Study of Metabolism and Mind,WITHDRAWN,,PHASE2,0.0,ACTUAL,Columbia University,,1.0,,18F-THK5351 was reported non-specific binding of MAO receptors.,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,OTHER,,,,,,,2020,0.0
NCT05265728,,2022-02-23,,,2024-07-03,2022-02-23,2022-03-03,ACTUAL,,,,,,,2024-07-03,2024-07-05,ACTUAL,2022-04-26,ACTUAL,2022-04-26,2024-07,2024-07-31,2024-05-27,ACTUAL,2024-05-27,2024-01-18,ACTUAL,2024-01-18,,INTERVENTIONAL,,,"A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple Sclerosis","A Single-Arm, Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered to Japanese Participants With Relapsing-Remitting Multiple Sclerosis Via a Subcutaneous Route of Administration",TERMINATED,,PHASE3,21.0,ACTUAL,Biogen,,1.0,,"Due to sponsor decision, not for efficacy or safety reasons.",f,,,,f,t,f,,,t,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,INDUSTRY,,,,,,,2024,0.0
NCT02523768,,2015-08-04,,,2021-01-15,2015-08-13,2015-08-14,ESTIMATED,,,,,,,2021-01-15,2021-01-20,ACTUAL,2011-01-08,ACTUAL,2011-01-08,2021-01,2021-01-31,2020-02-24,ACTUAL,2020-02-24,2020-01-24,ACTUAL,2020-01-24,,INTERVENTIONAL,PIRAT,,Prevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive Treatment,Prevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive Treatment,TERMINATED,,PHASE4,117.0,ACTUAL,Centre Hospitalier Universitaire de Saint Etienne,,2.0,,Difficulties for recruting patients,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,OTHER,,,,,,,2020,0.0
NCT02755597,,2016-04-20,2023-07-12,2021-07-16,2023-08-18,2016-04-27,2016-04-29,ESTIMATED,2023-08-18,2023-08-22,ACTUAL,2021-07-16,2021-07-20,ACTUAL,2023-08-18,2023-08-22,ACTUAL,2016-07-11,ACTUAL,2016-07-11,2023-08,2023-08-31,2022-08-15,ACTUAL,2022-08-15,2021-03-15,ACTUAL,2021-03-15,,INTERVENTIONAL,Bellini,"Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization",A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy,"A Phase 3, Multicenter, Randomized, Double Blind Study of Bortezomib and Dexamethasone in Combination With Either Venetoclax or Placebo in Subjects With Relapsed or Refractory Multiple Myeloma Who Are Sensitive or Naïve to Proteasome Inhibitors",COMPLETED,,PHASE3,291.0,ACTUAL,AbbVie,,2.0,,,t,,,,t,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,INDUSTRY,,NCT03123029,AVAILABLE,,,,2022,1.0
NCT01889186,,2013-06-26,2021-10-06,,2021-11-19,2013-06-27,2013-06-28,ESTIMATED,2021-11-19,2021-12-16,ACTUAL,,,,2021-11-19,2021-12-16,ACTUAL,2013-06-27,ACTUAL,2013-06-27,2021-11,2021-11-30,2020-12-15,ACTUAL,2020-12-15,2020-10-28,ACTUAL,2020-10-28,,INTERVENTIONAL,,All treated participants: all participants who received at least one dose of ABT-199 in either the Main Cohort or Safety Expansion Cohort,A Study of the Efficacy of ABT-199 in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia With the 17p Deletion,A Phase 2 Open-Label Study of the Efficacy of ABT-199 (GDC-0199) in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia Harboring the 17p Deletion,COMPLETED,,PHASE2,158.0,ACTUAL,AbbVie,,2.0,,,t,,,,t,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,INDUSTRY,,NCT03123029,AVAILABLE,,,,2020,1.0
NCT03646916,,2018-08-23,,,2021-01-19,2018-08-23,2018-08-24,ACTUAL,,,,,,,2021-01-19,2021-01-22,ACTUAL,2020-09-15,ACTUAL,2020-09-15,2021-01,2021-01-31,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Intraoperative Dexamethasone and Its Effect on Hyperglycemia,Effect of Pre-Operative Dexamethasone Dose on the Post-Operative Management of Blood Sugar in Diabetic Patients,WITHDRAWN,,PHASE4,0.0,ACTUAL,Ascension Health,,2.0,,Lack of patients,f,,,,f,t,f,,,,,,,,,,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,INDUSTRY,,,,,,,2020,0.0
NCT03761030,,2018-11-29,2023-05-02,,2023-05-18,2018-11-29,2018-12-03,ACTUAL,2023-05-18,2023-05-22,ACTUAL,,,,2023-05-18,2023-05-22,ACTUAL,2019-01-09,ACTUAL,2019-01-09,2023-05,2023-05-31,2021-09-08,ACTUAL,2021-09-08,2021-09-08,ACTUAL,2021-09-08,,INTERVENTIONAL,,,L-DOPA vs. Placebo for Depression and Psychomotor Slowing in Older Adults,Targeting Dopaminergic Mechanisms of Slowing to Improve Late Life Depression,TERMINATED,,PHASE4,51.0,ACTUAL,New York State Psychiatric Institute,Data collected in the trial have been presented as required but are considered unreliable.,2.0,,The project end date was reached prior to the full sample enrollment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,OTHER,,,,,,,2021,0.0
NCT03515941,,2018-04-24,2020-08-13,,2020-10-09,2018-04-24,2018-05-04,ACTUAL,2020-10-09,2020-10-12,ACTUAL,,,,2020-10-09,2020-10-12,ACTUAL,2018-06-22,ACTUAL,2018-06-22,2020-10,2020-10-31,2020-06-18,ACTUAL,2020-06-18,2020-03-17,ACTUAL,2020-03-17,,INTERVENTIONAL,GABLE,,Postoperative Chemoradiation or Chemotherapy After Preoperative Chemotherapy for Gastric Cancers,"A Pilot Study in Gastric Cancer of Assignment to Postoperative Chemoradiation or Chemotherapy Based Upon Surgical Lymph Node Assessment After Preoperative Chemotherapy, With Gene Assay as Correlate of Biologic Response",TERMINATED,,EARLY_PHASE1,6.0,ACTUAL,Baylor College of Medicine,,2.0,,The PI has decided to close the study due to the outdated study design.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,OTHER,,,,,,,2020,0.0
NCT02897830,,2015-07-17,,,2020-11-09,2016-09-07,2016-09-13,ESTIMATED,,,,,,,2020-11-09,2020-11-12,ACTUAL,2016-08-05,ACTUAL,2016-08-05,2020-11,2020-11-30,2020-08-31,ACTUAL,2020-08-31,2018-11,ACTUAL,2018-11-30,,INTERVENTIONAL,IFM2014-03,,"Ixazomib, Lenalidomide, Dexamethasone Induction and Extended Consolidation Plus Lenalidomide Maintenance in Multiple Myeloma","Evaluation of Ixazomib, Lenalidomide, Dexamethasone Induction and Extended Consolidation Followed by Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients ≤65 Years Eligible for High Dose Therapy",TERMINATED,,PHASE2,46.0,ACTUAL,"University Hospital, Toulouse",,1.0,,negatives results,f,,,,f,,,,,,,,,,,NO,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,OTHER,,,,,,,2020,0.0
NCT03234153,,2017-07-26,,,2020-06-16,2017-07-26,2017-07-31,ACTUAL,,,,,,,2020-06-16,2020-06-17,ACTUAL,2018-07-15,ACTUAL,2018-07-15,2020-06,2020-06-30,2020-05-18,ACTUAL,2020-05-18,2019-11-08,ACTUAL,2019-11-08,,INTERVENTIONAL,NITIMIB,,Neoadjuvant Immunotherapy With Durvalumab and Tremelimumab for Bladder Cancer Patients Ineligible for Cisplatin,Neoadjuvant Immunotherapy With Durvalumab in Combination With Tremelimumab in Patients With Muscle-invasive Bladder Cancer Ineligible for Cisplatin-based Chemotherapy.,TERMINATED,,PHASE2,6.0,ACTUAL,"Insel Gruppe AG, University Hospital Bern",,1.0,,low accrual,f,,,,f,f,f,,,,,,,,,,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,OTHER,,,,,,,2020,0.0
NCT02792192,,2016-06-02,2021-08-23,,2021-09-29,2016-06-02,2016-06-07,ESTIMATED,2021-09-29,2021-10-28,ACTUAL,,,,2021-09-29,2021-10-28,ACTUAL,2016-06-13,ACTUAL,2016-06-13,2021-09,2021-09-30,2020-09-29,ACTUAL,2020-09-29,2020-09-29,ACTUAL,2020-09-29,,INTERVENTIONAL,,"Participants were enrolled only in Cohort 1 of this study. The Sponsor decided to stop further enrollment for Cohorts 2 and 3 after the enrollment of 24 participants in Cohort 1 (BCG-unresponsive cohort), as the study had met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.",Safety and Pharmacology Study of Atezolizumab Alone and in Combination With Bacille Calmette-Guérin (BCG) in High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Participants,"A Phase Ib/II, Open-Label Study of the Safety and Pharmacology of Atezolizumab Administered With or Without Bacille Calmette-Guérin in Patients With High-Risk Non-Muscle-Invasive Bladder Cancer",TERMINATED,,PHASE1/PHASE2,24.0,ACTUAL,Hoffmann-La Roche,"Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1 (BCG-unresponsive cohort), as the study had met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.",4.0,,The study was terminated early as the study had met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.,f,,,,t,,,,,,,,,,,,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,INDUSTRY,,,,,,,2020,0.0
NCT04272333,,2020-02-10,,,2022-04-06,2020-02-12,2020-02-17,ACTUAL,,,,,,,2022-04-06,2022-04-14,ACTUAL,2021-10-15,ACTUAL,2021-10-15,2022-04,2022-04-30,2022-03-25,ACTUAL,2022-03-25,2022-03-25,ACTUAL,2022-03-25,,INTERVENTIONAL,,,Intratumoral Microdosing of Motolimod in HNSCC,A Phase 0 Study Using the CIVO® Platform to Evaluate Intratumoral Microdoses of Motolimod Singly and in Combination With Nivolumab in Patients With Head and Neck Cancer,TERMINATED,,EARLY_PHASE1,1.0,ACTUAL,Presage Biosciences,,1.0,,Partner Termination,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,INDUSTRY,,,,,,,2022,0.0
NCT04084444,,2019-09-05,,,2023-03-28,2019-09-06,2019-09-10,ACTUAL,,,,,,,2023-03-28,2023-03-31,ACTUAL,2019-12-25,ACTUAL,2019-12-25,2022-07,2022-07-31,2022-07-05,ACTUAL,2022-07-05,2022-07-05,ACTUAL,2022-07-05,,INTERVENTIONAL,,,Safety and Efficacy of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients,"Efficacy and Safety of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients: A Multicenter, Randomized, Double-blind, Dose-finding, Placebo-controlled Study",COMPLETED,,PHASE2,151.0,ACTUAL,"Shanghai Pharmaceuticals Holding Co., Ltd",,3.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,INDUSTRY,,,,,,,2022,1.0
NCT03426267,,2018-02-02,2021-03-03,,2021-05-14,2018-02-02,2018-02-08,ACTUAL,2021-05-14,2021-05-17,ACTUAL,,,,2021-05-14,2021-05-17,ACTUAL,2018-09-28,ACTUAL,2018-09-28,2021-05,2021-05-31,2020-03-05,ACTUAL,2020-03-05,2020-03-05,ACTUAL,2020-03-05,,INTERVENTIONAL,,modified intent-to-treat population,Evaluation of Efficacy and Safety of SDN-037,"A Randomized, Double-Masked, Parallel Group, Multicenter, Study To Evaluate Efficacy And Safety of SDN -037 Twice Daily Compared With Vehicle For The Treatment Of Inflammation And Pain Associated With Ocular Surgery.",COMPLETED,,PHASE3,325.0,ACTUAL,Sun Pharma Advanced Research Company Limited,,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2020,1.0
NCT04347980,,2020-04-09,,,2021-08-06,2020-04-14,2020-04-15,ACTUAL,,,,,,,2021-08-06,2021-08-12,ACTUAL,2020-04-17,ACTUAL,2020-04-17,2021-08,2021-08-31,2020-08-07,ACTUAL,2020-08-07,2020-08-07,ACTUAL,2020-08-07,,INTERVENTIONAL,DHYSCO,,Dexamethasone Treatment for Severe Acute Respiratory Distress Syndrome Induced by COVID-19,"Dexamethasone Combined With Hydroxychloroquine Compared to Hydroxychloroquine Alone for Treatment of Severe Acute Respiratory Distress Syndrome Induced by Coronavirus Disease 19 (COVID-19): a Multicentre, Randomised Controlled Trial",TERMINATED,,PHASE3,5.0,ACTUAL,Centre Chirurgical Marie Lannelongue,,2.0,,ANSM RECOMMANDATION,f,,,,t,f,f,,,f,,,Beginning 3 months and ending 24 months following article publication,Researchers who provide a methodologically sound and proposal. Data are available for 24 months and request should be addressed by email,,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)",2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,OTHER,,,,,,,2020,0.0
NCT04622774,,2020-10-27,,,2024-03-13,2020-11-04,2020-11-10,ACTUAL,,,,,,,2024-03-13,2024-03-15,ACTUAL,2020-10-26,ACTUAL,2020-10-26,2024-03,2024-03-31,2023-12-31,ACTUAL,2023-12-31,2023-12-31,ACTUAL,2023-12-31,,INTERVENTIONAL,,,First-in-Human Study of IMGC936 in Patients With Advanced Solid Tumors,"A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGC936 (Anti-ADAM9 Antibody Drug Conjugate) in Patients With Advanced Solid Tumors",COMPLETED,,PHASE1/PHASE2,56.0,ACTUAL,"ImmunoGen, Inc.",,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2023,1.0
NCT03892044,,2019-03-25,,,2024-04-30,2019-03-25,2019-03-27,ACTUAL,,,,,,,2024-04-30,2024-05-02,ACTUAL,2019-11-05,ACTUAL,2019-11-05,2024-04,2024-04-30,2024-02-14,ACTUAL,2024-02-14,2024-02-14,ACTUAL,2024-02-14,,INTERVENTIONAL,,,Duvelisib and Nivolumab in Treating Patients With Richter Syndrome or Transformed Follicular Lymphoma,A Phase I Study of Duvelisib in Combination With Nivolumab for Patients With Richter's Syndrome and Transformed Follicular Lymphoma,COMPLETED,,PHASE1,7.0,ACTUAL,Ohio State University Comprehensive Cancer Center,,1.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,OTHER,,,,,,,2024,1.0
NCT04228666,,2020-01-03,,,2021-07-02,2020-01-10,2020-01-14,ACTUAL,,,,,,,2021-07-02,2021-07-07,ACTUAL,2020-03-01,ACTUAL,2020-03-01,2021-02,2021-02-28,2022-02-01,ESTIMATED,2022-02-01,2022-02-01,ESTIMATED,2022-02-01,,INTERVENTIONAL,,,A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Alzheimer's Disease,A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Alzheimer's Disease,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Hope Biosciences,,1.0,,Due to COVID 19 Pandemic,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,INDUSTRY,,,,,,,2022,0.0
NCT03319784,,2017-09-16,,,2019-02-11,2017-10-19,2017-10-24,ACTUAL,,,,,,,2019-02-11,2019-02-15,ACTUAL,2018-09-05,ESTIMATED,2018-09-05,2019-02,2019-02-28,2020-10-05,ESTIMATED,2020-10-05,2020-09-05,ESTIMATED,2020-09-05,,INTERVENTIONAL,,,Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients,A Randomized Single Blinded Prospective Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients,WITHDRAWN,,PHASE4,0.0,ACTUAL,Milton S. Hershey Medical Center,,2.0,,never initiated,f,,,,,t,f,,,f,,,,,,,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,OTHER,,,,,,,2020,0.0
NCT02649439,,2016-01-06,2021-03-24,,2022-11-10,2016-01-06,2016-01-07,ESTIMATED,2021-06-11,2021-07-06,ACTUAL,,,,2022-11-10,2022-11-14,ACTUAL,2015-12-22,ACTUAL,2015-12-22,2022-11,2022-11-30,2022-10-01,ACTUAL,2022-10-01,2019-03-28,ACTUAL,2019-03-28,,INTERVENTIONAL,,,Prostvac in Patients With Biochemically Recurrent Prostate Cancer,Prostvac in Patients With Biochemically Recurrent Prostate Cancer,COMPLETED,,PHASE2,97.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,NIH,,,,,,,2022,1.0
NCT05120375,,2021-11-03,,,2023-10-08,2021-11-03,2021-11-15,ACTUAL,,,,,,,2023-10-08,2023-10-11,ACTUAL,2022-02-17,ACTUAL,2022-02-17,2023-10,2023-10-31,2023-04-07,ACTUAL,2023-04-07,2023-04-07,ACTUAL,2023-04-07,,INTERVENTIONAL,,,Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients in China,"A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6021 as Mono Therapy or in Combination With Tislelizumab in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1,5.0,ACTUAL,Bio-Thera Solutions,,8.0,,"Based on the disclosed global research data on the same target drugs, the company has carefully considered and decided to terminate the project to optimize the existing research pipeline.",f,,,,,f,f,,,,,,,,,NO,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,INDUSTRY,,,,,,,2023,0.0
NCT04411472,,2020-05-28,2024-02-01,,2024-05-31,2020-05-28,2020-06-02,ACTUAL,2024-05-31,2024-06-03,ACTUAL,,,,2024-05-31,2024-06-03,ACTUAL,2020-11-02,ACTUAL,2020-11-02,2024-05,2024-05-31,2022-08-18,ACTUAL,2022-08-18,2022-08-18,ACTUAL,2022-08-18,,INTERVENTIONAL,,Baseline characteristics are presented for the modified intent-to-treat population,(Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI,"A DB, Placebo-Controlled, Two-Arm Parallel-Group, Phase 3 RCT to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients With SA-AKI",TERMINATED,,PHASE3,676.0,ACTUAL,AM-Pharma,The trial was terminated early due to futility being reached for the primary endpoint of all cause mortality at day 28 at the interim analysis.,2.0,,The Data Monitoring Committee (DMC) concluded that the pre-specified futility threshold was met and that there was no safety concern.,,,,,t,t,f,,,,,,,,,,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,INDUSTRY,,,,,,,2022,0.0
NCT02527434,,2015-08-12,2019-02-13,,2023-11-14,2015-08-18,2015-08-19,ESTIMATED,2019-02-13,2019-03-05,ACTUAL,,,,2023-11-14,2023-11-15,ACTUAL,2015-11-02,ACTUAL,2015-11-02,2023-10,2023-10-31,2023-03-28,ACTUAL,2023-03-28,2018-02-17,ACTUAL,2018-02-17,,INTERVENTIONAL,,Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).,Study of Tremelimumab in Patients With Advanced Solid Tumors,"A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors",COMPLETED,,PHASE2,64.0,ACTUAL,AstraZeneca,,1.0,,,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,INDUSTRY,,,,,,,2023,1.0
NCT03439254,,2018-02-14,2023-09-07,,2023-10-19,2018-02-19,2018-02-20,ACTUAL,2023-10-19,2023-10-23,ACTUAL,,,,2023-10-19,2023-10-23,ACTUAL,2017-08-30,ACTUAL,2017-08-30,2023-10,2023-10-31,2022-09-08,ACTUAL,2022-09-08,2022-09-08,ACTUAL,2022-09-08,,INTERVENTIONAL,REVERSE,Intent-To-Treat (ITT) Population: included all randomized participants.,Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis,"A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis",COMPLETED,,PHASE3,919.0,ACTUAL,Intercept Pharmaceuticals,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2022,1.0
NCT02361346,,2015-02-03,2022-05-24,,2022-07-18,2015-02-06,2015-02-11,ESTIMATED,2022-07-18,2022-08-18,ACTUAL,,,,2022-07-18,2022-08-18,ACTUAL,2015-02,ACTUAL,2015-02-28,2022-07,2022-07-31,2021-03-22,ACTUAL,2021-03-22,2021-03-22,ACTUAL,2021-03-22,,INTERVENTIONAL,MT-3724NHL001,"Part 2 was analyzed as a single arm as data was not collected for each dose level separately. As no participants from Part 3 had shown a response and as potential risks outweighed benefits, the study was terminated and no participants entered Part 4.","Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL","Safety, Pharmacodynamics and Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL",TERMINATED,,PHASE1/PHASE2,38.0,ACTUAL,"Molecular Templates, Inc.",,9.0,,Sponsor decision following clinical hold,f,,,,t,,,,,,,,,,,NO,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,INDUSTRY,,,,,,,2021,0.0
NCT04430036,,2020-05-08,2024-03-06,,2024-04-01,2020-06-10,2020-06-12,ACTUAL,2024-04-01,2024-04-04,ACTUAL,,,,2024-04-01,2024-04-04,ACTUAL,2020-10-14,ACTUAL,2020-10-14,2024-04,2024-04-30,2022-03-14,ACTUAL,2022-03-14,2021-10-18,ACTUAL,2021-10-18,,INTERVENTIONAL,,,AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer,A Phase II Trial of Neoadjuvant AGEN1884 Plus AGEN2034 in Combination With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer Prior to Radical Cystectomy,TERMINATED,,PHASE2,4.0,ACTUAL,The University of Texas Health Science Center at San Antonio,,1.0,,PI left the institution,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,OTHER,,,,,,,2022,0.0
NCT04961658,,2021-06-24,,,2024-04-12,2021-07-05,2021-07-14,ACTUAL,,,,,,,2024-04-12,2024-04-16,ACTUAL,2021-08-11,ACTUAL,2021-08-11,2024-04,2024-04-30,2024-01-08,ACTUAL,2024-01-08,2023-08-10,ACTUAL,2023-08-10,,INTERVENTIONAL,AMETHYST,,Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients,Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients,TERMINATED,,PHASE1,11.0,ACTUAL,Northern Therapeutics,,4.0,,Funding Decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2024,0.0
NCT02041533,,2014-01-19,2017-06-26,,2023-02-02,2014-01-19,2014-01-22,ESTIMATED,2017-06-26,2017-07-26,ACTUAL,,,,2023-02-02,2023-03-02,ACTUAL,2014-03-27,ACTUAL,2014-03-27,2023-02,2023-02-28,2022-05-27,ACTUAL,2022-05-27,2016-07-01,ACTUAL,2016-07-01,,INTERVENTIONAL,,All randomized participants,"An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)","An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer",COMPLETED,,PHASE3,541.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,INDUSTRY,,,,,,,2022,1.0
NCT03752099,,2018-11-20,,,2023-09-22,2018-11-21,2018-11-23,ACTUAL,,,,,,,2023-09-22,2023-09-26,ACTUAL,2019-01-18,ACTUAL,2019-01-18,2023-09,2023-09-30,2023-03-15,ACTUAL,2023-03-15,2023-03-15,ACTUAL,2023-03-15,,INTERVENTIONAL,,,To Evaluate Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer,A Phase 1b/2 Study to Evaluate the Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer,TERMINATED,,PHASE1/PHASE2,80.0,ACTUAL,Veru Inc.,,6.0,,Administrative decision,,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2023,0.0
NCT04236258,,2020-01-16,2022-06-30,,2022-11-10,2020-01-17,2020-01-22,ACTUAL,2022-11-10,2022-11-30,ACTUAL,,,,2022-11-10,2022-11-30,ACTUAL,2020-01-24,ACTUAL,2020-01-24,2022-11,2022-11-30,2021-06-30,ACTUAL,2021-06-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,,,Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period,A Randomized Controlled Trial Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period,COMPLETED,,PHASE4,94.0,ACTUAL,Brigham and Women's Hospital,The trial was conducted during the COVID pandemic which fundamentally changed the way patients interact with the medical system.,2.0,,,f,,,,f,t,f,,,,,,The data will be available for approximately six months after the study's conclusion.,Data access requests will be reviewed by the internal Institutional Review Board.,,YES,De-identified individual participant data will be made available to other researchers for all primary and secondary outcomes as well as demographic data.,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,OTHER,,,,,,,2021,1.0
NCT04437368,,2020-06-03,,,2024-07-03,2020-06-17,2020-06-18,ACTUAL,,,,,,,2024-07-03,2024-07-08,ACTUAL,2020-07-14,ACTUAL,2020-07-14,2024-07,2024-07-31,2024-04-05,ACTUAL,2024-04-05,2024-04-05,ACTUAL,2024-04-05,,INTERVENTIONAL,EXPLORE,,EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005,"EXPLORE: A Phase II, Outcomes Assessor-masked, Multicentre, Randomised Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration",TERMINATED,,PHASE2,98.0,ACTUAL,Gyroscope Therapeutics Limited,,5.0,,The study was terminated due to the interim analysis demonstrating lack of treatment efficacy.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,INDUSTRY,,,,,,,2024,0.0
NCT04382755,,2020-05-07,2022-07-04,,2023-09-01,2020-05-08,2020-05-11,ACTUAL,2023-09-01,2023-09-14,ACTUAL,,,,2023-09-01,2023-09-14,ACTUAL,2020-05-22,ACTUAL,2020-05-22,2023-09,2023-09-30,2021-04-09,ACTUAL,2021-04-09,2020-12-29,ACTUAL,2020-12-29,,INTERVENTIONAL,ZILU-COV,,"Zilucoplan® in Improving Oxygenation, Short-, Longterm Outcome of COVID19 Patients With Acute Hypoxic Respiratory Failure",A Prospective Randomized Open-label Interventional Study to Investigate the Efficacy of Complement C5 Inhibition With Zilucoplan® in Improving Oxygenation and Short-and Longterm Outcome of COVID19 Patients With Acute Hypoxic Respiratory Failure,COMPLETED,,PHASE2,81.0,ACTUAL,"University Hospital, Ghent",,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,OTHER,,,,,,,2021,1.0
NCT02411786,,2015-03-27,,,2021-02-02,2015-04-03,2015-04-08,ESTIMATED,,,,,,,2021-02-02,2021-02-04,ACTUAL,2015-08-24,ACTUAL,2015-08-24,2021-02,2021-02-28,2020-11-28,ACTUAL,2020-11-28,2019-05-01,ACTUAL,2019-05-01,,INTERVENTIONAL,,,A Phase I Study of a DNA Vaccine Encoding Androgen Receptor Ligand-Binding Domain (AR LBD) +/-GMCSF,"A Phase I Study of a DNA Vaccine Encoding Androgen Receptor Ligand-Binding Domain (AR LBD), With or Without Granulocyte Macrophage Colony-Stimulating Factor Adjuvant, in Patients With Metastatic Prostate Cancer",COMPLETED,,PHASE1,40.0,ACTUAL,"University of Wisconsin, Madison",,4.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,OTHER,,,,,,,2020,1.0
NCT02597153,,2015-11-03,,,2017-05-23,2015-11-03,2015-11-05,ESTIMATED,,,,,,,2017-05-23,2017-05-24,ACTUAL,2015-10,ACTUAL,2015-10-31,2017-05,2017-05-31,2020-10,ESTIMATED,2020-10-31,2017-10,ESTIMATED,2017-10-31,,INTERVENTIONAL,,,Phase II Clinical Study of PLM60 for the Treatment of Cutaneous T Cell Lymphomas,"A Single-arm, Open, Multi-center Phase II Clinical Trial of Mitoxantrone HCL Liposome Injection in Subjects With Relapsed Cutaneous T Cell Lymphomas",TERMINATED,,PHASE2,1.0,ACTUAL,"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.",,1.0,,Just one subject enrolled in this trial during one and a half years.,f,,,,f,,,,,,,,,,,,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,INDUSTRY,,,,,,,2020,0.0
NCT03652974,,2018-08-25,,,2022-09-01,2018-08-28,2018-08-31,ACTUAL,,,,,,,2022-09-01,2022-09-06,ACTUAL,2018-09-06,ACTUAL,2018-09-06,2021-06,2021-06-30,2021-08-30,ACTUAL,2021-08-30,2021-08-30,ACTUAL,2021-08-30,,INTERVENTIONAL,,,Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy,Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy,COMPLETED,,PHASE4,145.0,ACTUAL,Shanghai Mental Health Center,,4.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,OTHER,,,,,,,2021,1.0
NCT03861988,,2019-03-01,2023-09-03,,2023-10-03,2019-03-04,2019-03-05,ACTUAL,2023-10-03,2023-10-05,ACTUAL,,,,2023-10-03,2023-10-05,ACTUAL,2019-08-22,ACTUAL,2019-08-22,2023-10,2023-10-31,2022-09-27,ACTUAL,2022-09-27,2022-09-22,ACTUAL,2022-09-22,,INTERVENTIONAL,,,Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery,Double-blind Trial of Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery,COMPLETED,,PHASE4,45.0,ACTUAL,Stanford University,,3.0,,,f,,,,f,t,f,,,f,,,,,,NO,No current plan to share data.,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,OTHER,,,,,,,2022,1.0
NCT03371173,,2017-10-16,,,2020-04-17,2017-12-06,2017-12-13,ACTUAL,,,,,,,2020-04-17,2020-04-21,ACTUAL,2018-03-27,ACTUAL,2018-03-27,2019-06,2019-06-30,2020-03-19,ACTUAL,2020-03-19,2020-03-19,ACTUAL,2020-03-19,,INTERVENTIONAL,ORION-PH-1,,ORal IrON Supplementation With Ferric Maltol in Patients With Pulmonary Hypertension (ORION-PH-1),"A Pilot Study to Explore Preliminary Safety, Tolerability and Efficacy of ORal IrON Supplementation With Ferric Maltol in Treating Iron Deficiency in Patients With Pulmonary Hypertension and Iron Deficiency Anemia",TERMINATED,,PHASE3,22.0,ACTUAL,Hannover Medical School,,1.0,,low recruitment rate; difficulties to achieve planned number of participants within reasonable time frame,f,,,,f,f,f,,,f,,,,,,,,2024-10-15 00:41:27.311377,2024-10-15 00:41:27.311377,OTHER,,,,,,,2020,0.0
NCT03187691,,2017-05-31,,,2019-03-06,2017-06-13,2017-06-15,ACTUAL,,,,,,,2019-03-06,2019-03-08,ACTUAL,2019-08,ESTIMATED,2019-08-31,2019-03,2019-03-31,2020-12,ESTIMATED,2020-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Safety and PK of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous and Lymphoblastic Leukaemia,An Open Label Phase II Clinical Study to Evaluate the Safety and Pharmacokinetics of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous (AML) and Lymphoblastic Leukaemia (ALL),WITHDRAWN,,PHASE2,0.0,ACTUAL,"Matinas BioPharma Nanotechnologies, Inc.",,3.0,,Protocol redundancy,,,,,f,t,f,,,,,,,,,NO,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2020,0.0
NCT05540665,,2022-09-12,,,2024-05-02,2022-09-12,2022-09-15,ACTUAL,,,,,,,2024-05-02,2024-05-03,ACTUAL,2023-04-26,ACTUAL,2023-04-26,2024-05,2024-05-31,2024-01-04,ACTUAL,2024-01-04,2024-01-04,ACTUAL,2024-01-04,,INTERVENTIONAL,,,Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN),"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating the Efficacy and Safety of Daxdilimab in Adult Participants With Active Proliferative Lupus Nephritis",TERMINATED,,PHASE2,19.0,ACTUAL,Amgen,,3.0,,Sponsor Decision,f,,,,t,t,f,,,t,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,INDUSTRY,,,,,,,2024,0.0
NCT04679350,,2020-12-21,,,2024-02-14,2020-12-21,2020-12-22,ACTUAL,,,,,,,2024-02-14,2024-02-15,ACTUAL,2021-03-18,ACTUAL,2021-03-18,2024-02,2024-02-29,2022-12-30,ACTUAL,2022-12-30,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,,,Efficacy and Safety of hzVSFv13 in Patients With COVID-19 Pneumonia,"A Multi Center, Randomized, Double-blind, Parallel Design, Phase 2 Study to Evaluate the Efficacy and Safety of hzVSFv13 Compared to Standard of Care After Intravenous(IV) Administration With Add-on Standard of Care in COVID-19 Moderate to Severe Patients",TERMINATED,,PHASE2,1.0,ACTUAL,"ImmuneMed, Inc.",,4.0,,A new study combining Phase III clinical trials has been planned.,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,INDUSTRY,,,,,,,2022,0.0
NCT03401229,,2017-12-13,2021-07-27,,2021-10-08,2018-01-09,2018-01-17,ACTUAL,2021-10-08,2021-10-12,ACTUAL,,,,2021-10-08,2021-10-12,ACTUAL,2018-01-15,ACTUAL,2018-01-15,2021-10,2021-10-31,2020-07-31,ACTUAL,2020-07-31,2020-07-31,ACTUAL,2020-07-31,,INTERVENTIONAL,OSTRO,"Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment.",Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis,"A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients With Severe Nasal Polyposis",COMPLETED,,PHASE3,413.0,ACTUAL,AstraZeneca,"During COVID-19 pandemic, for ongoing patients, patient dosing, scheduled visits, and nasal endoscopies are inevitable impacted. Week 40 was made as the primary timepoint to mitigate the impact of COVID disruptions on the primary endpoint.",2.0,,,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2020,1.0
NCT03222089,,2017-07-03,,,2018-03-23,2017-07-16,2017-07-19,ACTUAL,,,,,,,2018-03-23,2018-03-27,ACTUAL,2017-07-20,ESTIMATED,2017-07-20,2018-03,2018-03-31,2020-07-20,ESTIMATED,2020-07-20,2019-07-20,ESTIMATED,2019-07-20,,INTERVENTIONAL,,,Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC,FOLFOXIRI in Combination With GM-CSF and IL-2 (FOLFOXIGIL) Versus FOLFOXIRI as First-line Treatment for Patients With Metastatic Colorectal Cancer: a Phase II Trial by the FNF Team.,WITHDRAWN,,PHASE2,0.0,ACTUAL,Fujian Cancer Hospital,,2.0,,Another study enrolling the similar group of patient are ongoing,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,OTHER_GOV,,,,,,,2020,0.0
NCT04092179,,2019-09-13,,,2024-01-23,2019-09-13,2019-09-17,ACTUAL,,,,,,,2024-01-23,2024-01-24,ACTUAL,2020-11-05,ACTUAL,2020-11-05,2024-01,2024-01-31,2023-10-26,ACTUAL,2023-10-26,2023-10-26,ACTUAL,2023-10-26,,INTERVENTIONAL,,,Study of Enasidenib and Venetoclax in IDH2-Mutated Blood Cancers,Phase Ib/II Study of IDH2 Inhibitor Enasidenib in Combination With BCL2 Inhibitor Venetoclax in Patients With IDH2-Mutated Myeloid Malignancies (ENAVEN-AML),TERMINATED,,PHASE1/PHASE2,27.0,ACTUAL,"University Health Network, Toronto",,1.0,,Insufficient Funding,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,OTHER,,,,,,,2023,0.0
NCT04189263,,2019-12-04,,,2023-04-16,2019-12-04,2019-12-06,ACTUAL,,,,,,,2023-04-16,2023-04-19,ACTUAL,2020-02-04,ACTUAL,2020-02-04,2023-04,2023-04-30,2023-03-30,ACTUAL,2023-03-30,2023-03-30,ACTUAL,2023-03-30,,INTERVENTIONAL,,,BREADS: Breast Adjuvant Diet Study,IIT2018-21-Amersi-BREADS BREADS: Breast Adjuvant Diet Study,TERMINATED,,PHASE2,6.0,ACTUAL,Cedars-Sinai Medical Center,,2.0,,"Low participant compliance, slow recruitment",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,OTHER,,,,,,,2023,0.0
NCT04843722,,2021-04-09,,,2021-12-14,2021-04-09,2021-04-13,ACTUAL,,,,,,,2021-12-14,2022-01-04,ACTUAL,2021-12,ESTIMATED,2021-12-31,2021-04,2021-04-30,2022-08,ESTIMATED,2022-08-31,2022-03,ESTIMATED,2022-03-31,,INTERVENTIONAL,,,COVID-19 Supplemental Vaccine Boost to Enhance T Cell Protection in Those Who Have Already Received EUA S-Based Vaccines,"Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of a Supplemental Spike & Nucleocapsid-targeted COVID-19 Vaccine to Enhance T Cell Based Immunogenicity in Participants Who Have Already Received Prime + Boost Vaccines Authorized For Emergency Use",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"ImmunityBio, Inc.",,2.0,,The sponsor has changed the development plans which is not for safety reasons.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,INDUSTRY,,,,,,,2022,0.0
NCT04589949,,2020-10-12,,,2022-03-22,2020-10-15,2020-10-19,ACTUAL,,,,,,,2022-03-22,2022-04-01,ACTUAL,2020-10-12,ACTUAL,2020-10-12,2022-03,2022-03-31,2022-03-01,ACTUAL,2022-03-01,2021-10-01,ACTUAL,2021-10-01,,INTERVENTIONAL,CoV-Early,,Early Convalescent Plasma Therapy for High-risk Patients With COVID-19 in Primary Care (the CoV-Early Study),Early Convalescent Plasma Therapy for High-risk Patients With COVID-19 in Primary Care (the CoV-Early Study),TERMINATED,,PHASE3,420.0,ACTUAL,Erasmus Medical Center,,2.0,,vaccination uptake 80% in the target population/new COVID variant,f,,,,t,f,f,,,,,,,,,,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,OTHER,,,,,,,2022,0.0
NCT04006925,,2019-06-27,2023-02-01,,2023-04-18,2019-07-01,2019-07-05,ACTUAL,2023-04-18,2023-05-10,ACTUAL,,,,2023-04-18,2023-05-10,ACTUAL,2019-09-10,ACTUAL,2019-09-10,2023-04,2023-04-30,2022-02-01,ACTUAL,2022-02-01,2022-02-01,ACTUAL,2022-02-01,,INTERVENTIONAL,,,Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate,Sodium Oxybate in Treatment-Resistant REM Sleep Behavior Disorder (RBD): A Randomized Placebo-Controlled Trial,COMPLETED,,PHASE4,24.0,ACTUAL,Stanford University,,2.0,,,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,OTHER,,,,,,,2022,1.0
NCT05022303,,2021-08-09,,,2024-06-12,2021-08-23,2021-08-26,ACTUAL,,,,,,,2024-06-12,2024-06-13,ACTUAL,2021-10-01,ACTUAL,2021-10-01,2024-06,2024-06-30,2024-05-15,ACTUAL,2024-05-15,2024-05-15,ACTUAL,2024-05-15,,INTERVENTIONAL,,,AT1001 for the Treatment of COVID-19 Related MIS-C,"A Phase 2a (Proof of Concept), Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AT1001 for the Treatment of COVID-19 Related Multisystem Inflammatory Syndrome in Children (MIS-C)",TERMINATED,,PHASE2,12.0,ACTUAL,Massachusetts General Hospital,,2.0,,Decline in MISC cases,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,OTHER,,,,,,,2024,0.0
NCT04167995,,2019-11-12,,,2022-12-23,2019-11-18,2019-11-19,ACTUAL,,,,,,,2022-12-23,2022-12-27,ACTUAL,2020-06-09,ACTUAL,2020-06-09,2022-12,2022-12-31,2021-10-30,ACTUAL,2021-10-30,2020-11-09,ACTUAL,2020-11-09,,INTERVENTIONAL,ADHD,,Assessment of Probiotics Lactobacillus in the Management of Attention Deficit Hyperactive Disorder,Assessment of Probiotic Strain Lactobacillus Acidophilus LB Supplementation as Adjunctive Management of Attention-deficit Hyperactivity Disorder in Children and Adolescents: a Randomized Controlled Clinical Trial,COMPLETED,,EARLY_PHASE1,80.0,ACTUAL,Ain Shams University,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,OTHER,,,,,,,2021,1.0
NCT03526874,,2018-05-04,2024-03-08,,2024-04-03,2018-05-04,2018-05-16,ACTUAL,2024-04-03,2024-04-30,ACTUAL,,,,2024-04-03,2024-04-30,ACTUAL,2019-04-03,ACTUAL,2019-04-03,2024-04,2024-04-30,2023-03-10,ACTUAL,2023-03-10,2023-03-10,ACTUAL,2023-03-10,,INTERVENTIONAL,,,Occipital Blocks for Acute Migraine,Occipital Nerve Blocks for Acute Treatment of Pediatric Migraine,COMPLETED,,PHASE3,63.0,ACTUAL,Children's Hospital of Philadelphia,,2.0,,,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,OTHER,,,,,,,2023,1.0
NCT03944473,,2019-04-30,,,2019-11-14,2019-05-08,2019-05-09,ACTUAL,,,,,,,2019-11-14,2019-11-18,ACTUAL,2019-06-20,ESTIMATED,2019-06-20,2019-11,2019-11-30,2020-07-20,ESTIMATED,2020-07-20,2020-07-20,ESTIMATED,2020-07-20,,INTERVENTIONAL,Sugammadex,,Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries,Accessor Blinded Randomized Controlled Study Evaluating the Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries,WITHDRAWN,,PHASE4,0.0,ACTUAL,Montefiore Medical Center,,2.0,,Stopped before IRB approval,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,OTHER,,,,,,,2020,0.0
NCT03589794,,2018-07-05,,,2023-07-06,2018-07-05,2018-07-18,ACTUAL,,,,,,,2023-07-06,2023-07-10,ACTUAL,2018-12-21,ACTUAL,2018-12-21,2021-04-19,2021-04-19,2022-07-05,ACTUAL,2022-07-05,2022-07-05,ACTUAL,2022-07-05,,INTERVENTIONAL,,,rCSP/AP10-602 [GLA-LSQ] Vaccine Trial,"A Phase I Challenge Study to Evaluate Safety, Immunogenicity, and Efficacy of a Malaria Vaccine (rCSP Adjuvanted With AP 10-602 [GLA-LSQ]), in Healthy Adults",COMPLETED,,PHASE1,65.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,7.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-16 10:40:01.720755,2024-10-16 10:40:01.720755,NIH,,,,,,,2022,1.0
NCT03283150,,2017-09-06,2023-01-20,,2024-06-24,2017-09-13,2017-09-14,ACTUAL,2023-03-23,2023-03-27,ACTUAL,,,,2024-06-24,2024-07-05,ACTUAL,2017-12-01,ACTUAL,2017-12-01,2024-06,2024-06-30,2022-01-20,ACTUAL,2022-01-20,2022-01-20,ACTUAL,2022-01-20,,INTERVENTIONAL,,No subjects were accrued to the baseline propofol and dexmedetomidine groups. The study was stopped early due to COVID decreasing participant flow and the frequency of the surgery dropping due to surgeon loss.,Deep Brain Stimulation (DBS) Sedation,Effects of Anesthesia Drugs on Neuronal Activity in the Basal Ganglia and Thalamus During Deep Brain Stimulation Electrode Implantation Surgery,TERMINATED,,PHASE4,20.0,ACTUAL,"University of Wisconsin, Madison",,3.0,,"Due to a decrease in scheduled study-eligible patients, we terminated the study prematurely",f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,OTHER,,,,,,,2022,0.0
NCT03315130,,2017-10-16,2022-05-31,2020-08-25,2022-07-26,2017-10-18,2017-10-19,ACTUAL,2022-05-31,2022-06-27,ACTUAL,2020-08-25,2020-09-01,ACTUAL,2022-07-26,2022-07-27,ACTUAL,2017-10-11,ACTUAL,2017-10-11,2022-07,2022-07-31,2020-11-19,ACTUAL,2020-11-19,2018-12-10,ACTUAL,2018-12-10,,INTERVENTIONAL,,Intent-to-Treat (ITT) population included all randomized participants.,Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis,"A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of RA101495 in Subjects With Generalized Myasthenia Gravis",COMPLETED,,PHASE2,45.0,ACTUAL,UCB Pharma,,3.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,INDUSTRY,,,,,,,2020,1.0
NCT05349617,,2022-04-21,,2024-06-18,2024-06-18,2022-04-21,2022-04-27,ACTUAL,,,,,2024-06-20,ACTUAL,2024-06-18,2024-06-20,ACTUAL,2022-05-12,ACTUAL,2022-05-12,2024-06,2024-06-30,2023-08-08,ACTUAL,2023-08-08,2023-06-19,ACTUAL,2023-06-19,,INTERVENTIONAL,,,Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years,A Phase 3 Safety and Immunogenicity Trial of the VLP-Based Chikungunya Virus Vaccine PXVX0317 in Adults ≥65 Years of Age,COMPLETED,,PHASE3,413.0,ACTUAL,Bavarian Nordic,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,INDUSTRY,,,,,,,2023,1.0
NCT06048770,,2023-09-11,,,2024-08-02,2023-09-20,2023-09-21,ACTUAL,,,,,,,2024-08-02,2024-08-06,ACTUAL,2023-09-01,ACTUAL,2023-09-01,2024-08,2024-08-31,2024-07-31,ACTUAL,2024-07-31,2024-07-31,ACTUAL,2024-07-31,,INTERVENTIONAL,,,A Study of RBI-4000 in Healthy Participants,"A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of RBI-4000 in Healthy Volunteers",TERMINATED,,PHASE1,89.0,ACTUAL,Replicate Bioscience,,5.0,,"Strategic business decision (not related to safety, efficacy, or quality)",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,INDUSTRY,,,,,,,2024,0.0
NCT04039477,,2019-07-26,,,2020-08-05,2019-07-29,2019-07-31,ACTUAL,,,,,,,2020-08-05,2020-08-07,ACTUAL,2020-07,ESTIMATED,2020-07-31,2020-08,2020-08-31,2020-08-05,ACTUAL,2020-08-05,2020-08-05,ACTUAL,2020-08-05,,INTERVENTIONAL,MARINA,,A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITP,"A Phase 2 Randomized, Dose-blind, Multicenter Study to Evaluate the Safety and Efficacy of KZR-616 in the Treatment of Patients With Autoimmune Hemolytic Anemia (AIHA) and Immune Thrombocytopenia (ITP)",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Kezar Life Sciences, Inc.",,2.0,,"Clinical trial activity slowdown due to COVID-19 pandemic, high screen fail rate, and lack of enrollment led to the decision to withdraw the MARINA study.",f,,,,,t,f,,,,,,,,,NO,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2020,0.0
NCT05096208,,2021-10-14,2023-03-17,,2023-03-17,2021-10-14,2021-10-27,ACTUAL,2023-03-17,2023-04-12,ACTUAL,,,,2023-03-17,2023-04-12,ACTUAL,2021-10-21,ACTUAL,2021-10-21,2023-03,2023-03-31,2022-04-04,ACTUAL,2022-04-04,2022-04-04,ACTUAL,2022-04-04,,INTERVENTIONAL,,Safety population included all randomized participants who received study intervention.,Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤49 Years of Age,"A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 3 LOTS OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN HEALTHY ADULTS",COMPLETED,,PHASE3,1028.0,ACTUAL,Pfizer,,4.0,,,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,INDUSTRY,,,,,,,2022,1.0
NCT05517837,,2022-08-24,,,2023-09-08,2022-08-24,2022-08-26,ACTUAL,,,,,,,2023-09-08,2023-09-13,ACTUAL,2022-09-13,ACTUAL,2022-09-13,2023-09,2023-09-30,2023-07-14,ACTUAL,2023-07-14,2023-07-14,ACTUAL,2023-07-14,,INTERVENTIONAL,,,"A Phase 1, First-in-Human Study of BMS-986421 in Healthy Participants","A Phase 1, Randomized, Multi-Part, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BMS-986421 in Healthy Participants",TERMINATED,,EARLY_PHASE1,46.0,ACTUAL,Bristol-Myers Squibb,,2.0,,Adverse change in the risk/benefit.,f,,,,f,t,f,,,,,,,,,NO,"BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html",2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2023,0.0
NCT04795531,,2021-03-10,,2022-11-11,2023-11-03,2021-03-10,2021-03-12,ACTUAL,,,,2022-11-11,2022-11-21,ACTUAL,2023-11-03,2023-11-07,ACTUAL,2021-03-24,ACTUAL,2021-03-24,2023-11,2023-11-30,2022-06-23,ACTUAL,2022-06-23,2022-06-23,ACTUAL,2022-06-23,,INTERVENTIONAL,ONWARDS 3,,"A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3)","A 26-week Double Blinded, Multiregional, Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Drugs, in Insulin naïve Subjects With Type 2 Diabetes.",COMPLETED,,PHASE3,588.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2022,1.0
NCT04549363,,2020-09-08,2023-11-21,,2023-11-21,2020-09-08,2020-09-16,ACTUAL,2023-11-21,2023-12-13,ACTUAL,,,,2023-11-21,2023-12-13,ACTUAL,2020-12-21,ACTUAL,2020-12-21,2023-11,2023-11-30,2022-11-21,ACTUAL,2022-11-21,2022-11-21,ACTUAL,2022-11-21,,INTERVENTIONAL,,,Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin,Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin (GSK2857916),TERMINATED,,PHASE3,16.0,ACTUAL,GlaxoSmithKline,,2.0,,The study has been terminated for reasons pertaining to feasibility,t,,,,f,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 14:36:41.749507,2024-10-15 14:36:41.749507,INDUSTRY,,NCT03763370,AVAILABLE,,,,2022,0.0
NCT04563871,,2020-09-14,,,2023-12-28,2020-09-20,2020-09-25,ACTUAL,,,,,,,2023-12-28,2024-01-03,ACTUAL,2020-11-17,ACTUAL,2020-11-17,2023-12,2023-12-31,2023-10-25,ACTUAL,2023-10-25,2023-10-25,ACTUAL,2023-10-25,,INTERVENTIONAL,BLOSSOM,,Efficacy and Safety of 80mg Osimertinib in Patients With Non-small Cell Lung Cancer(NSCLC),"A Phase II, Open-label, Single-arm, Multicenter, Efficacy and Safety of 80mg Osimertinib in Patients With Leptomeningeal Metastases(LM) Associated With EGFR Mutation-positive Non-small Cell Lung Cancer(NSCLC)",COMPLETED,,PHASE2,73.0,ACTUAL,Samsung Medical Center,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,OTHER,,,,,,,2023,1.0
NCT03077698,,2017-02-27,2022-03-09,,2022-05-18,2017-03-07,2017-03-13,ACTUAL,2022-05-18,2022-06-07,ACTUAL,,,,2022-05-18,2022-06-07,ACTUAL,2017-06-14,ACTUAL,2017-06-14,2022-05,2022-05-31,2020-07-17,ACTUAL,2020-07-17,2020-07-17,ACTUAL,2020-07-17,,INTERVENTIONAL,,,An Endometrial Cancer Study for Women With Recurrent or Persistent Endometrial Cancer,"A Phase 2, Single Arm, Two Period Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Endometrial Carcinoma",TERMINATED,,PHASE2,25.0,ACTUAL,"Xenetic Biosciences, Inc.","The study was discontinued early due to a change in development strategy and not due safety concern. No safety concerns were noted during the trial. This change in development strategy was the determining factor in the decision to discontinue the study. Because the study was terminated early, the planned analysis was not conducted, as full enrollment was not met.",1.0,,The study was discontinued due to a change in development strategy and not due safety concern.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,INDUSTRY,,,,,,,2020,0.0
NCT02394028,,2015-02-27,2022-09-01,,2022-10-21,2015-03-16,2015-03-20,ESTIMATED,2022-10-21,2022-11-16,ACTUAL,,,,2022-10-21,2022-11-16,ACTUAL,2015-03-20,ACTUAL,2015-03-20,2022-10,2022-10-31,2021-09-07,ACTUAL,2021-09-07,2021-09-07,ACTUAL,2021-09-07,,INTERVENTIONAL,BERGAMOT,"Safety Population: All participants randomized who received at least one dose of study treatment, grouped under the treatment arm received.",A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease,"A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease",COMPLETED,,PHASE3,1035.0,ACTUAL,Hoffmann-La Roche,,11.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,INDUSTRY,,,,,,,2021,1.0
NCT04229095,,2020-01-09,2023-01-03,,2023-04-04,2020-01-13,2020-01-14,ACTUAL,2023-04-04,2023-04-26,ACTUAL,,,,2023-04-04,2023-04-26,ACTUAL,2021-11-17,ACTUAL,2021-11-17,2023-04,2023-04-30,2022-11-08,ACTUAL,2022-11-08,2022-11-08,ACTUAL,2022-11-08,,INTERVENTIONAL,,,Medication Development in Alcoholism: Suvorexant Versus Placebo,Medication Development for Protracted Abstinence in Alcoholism: Suvorexant Versus Placebo,COMPLETED,,PHASE2,26.0,ACTUAL,The Scripps Research Institute,"The actual enrollment was 26 subjects, relative to the planned enrollment of 50 subjects, due to chronic staffing problems for overnight studies at the Altman Clinical and Translational Research Institute (ACTRI) at the University of California-San Diego (UCSD) that resulted in multiple pre-randomization visit cancellations. Alternative inpatient beds were not available at general hospitals due to the prioritization of their facilities for COVID-19 patients.",2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,OTHER,,,,,,,2022,1.0
NCT04562597,,2020-09-10,2022-11-18,,2023-01-19,2020-09-18,2020-09-24,ACTUAL,2023-01-19,2023-02-14,ACTUAL,,,,2023-01-19,2023-02-14,ACTUAL,2021-01-20,ACTUAL,2021-01-20,2023-01,2023-01-31,2022-05-21,ACTUAL,2022-05-21,2022-05-20,ACTUAL,2022-05-20,,INTERVENTIONAL,,,A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery.,A Pilot Trial to Determine the Effective Dose of N-acetylcysteine for Opioid Reduction in Patients Undergoing Spine Surgery.,COMPLETED,,PHASE1/PHASE2,50.0,ACTUAL,Medical University of South Carolina,"* Opioid consumption was highly variable. This is likely due to the small sample size.~* Data only collected up to 48 hours postoperative, and this limits our ability to comment more on the usefulness of NAC as an agent for patients with chronic pain.",6.0,,,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,OTHER,,,,,,,2022,1.0
NCT03615144,,2018-07-30,2021-02-05,,2021-03-01,2018-07-30,2018-08-03,ACTUAL,2021-02-05,2021-02-24,ACTUAL,,,,2021-03-01,2021-03-24,ACTUAL,2018-07-23,ACTUAL,2018-07-23,2020-11,2020-11-30,2020-11-13,ACTUAL,2020-11-13,2020-11-13,ACTUAL,2020-11-13,,INTERVENTIONAL,,Participant accrual low and the study was closed.,"TCR Alpha Beta T-cell and CD19 B-cell Depleted Peripheral Blood Stem Cell Transplantation Using the CliniMACS System for Patients With Non-Malignant Hematologic Disorders From Matched or Mismatched, Related or Unrelated Donors","A Phase II Trial of Alpha Beta T-cell and CD19 B-cell Depleted Peripheral Blood Stem Cell Transplantation Using the CliniMACS System for Patients With Non-Malignant Hematologic Disorders From Matched or Mismatched, Related or Unrelated Donors",TERMINATED,,PHASE2,1.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,2.0,,Participant accrual low and the study was closed,,,,,,t,f,,,,,,,,,,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,OTHER,,,,,,,2020,0.0
NCT04306692,,2020-02-12,,,2022-12-16,2020-03-12,2020-03-13,ACTUAL,,,,,,,2022-12-16,2022-12-21,ACTUAL,2020-07-02,ACTUAL,2020-07-02,2022-12,2022-12-31,2022-01-31,ACTUAL,2022-01-31,2021-04-20,ACTUAL,2021-04-20,,INTERVENTIONAL,,,Myo-inositol Versus Clomiphene Citrate in PCOS,Myo-inositol Versus Clomiphene Citrate as First Line Treatment for Ovulation Induction in PCOS,TERMINATED,,PHASE4,12.0,ACTUAL,"University Hospital, Ghent",,2.0,,clomiphene citrate is no longer being considered as standard treatment for polycystic ovary syndrome,f,,,,,f,f,,,,,,,,,,,2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,OTHER,,,,,,,2022,0.0
NCT04016779,,2019-07-10,2022-05-19,,2022-06-16,2019-07-10,2019-07-11,ACTUAL,2022-06-16,2022-07-12,ACTUAL,,,,2022-06-16,2022-07-12,ACTUAL,2019-11-20,ACTUAL,2019-11-20,2022-06,2022-06-30,2020-10-10,ACTUAL,2020-10-10,2020-10-10,ACTUAL,2020-10-10,,INTERVENTIONAL,,"Full analysis set (FAS) Population: The FAS population includes subjects who were randomized, took at least one dose of study medication, have a baseline Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) assessment and have at least one post-baseline AISRS assessment.",Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Flexible-Dose Study of the Efficacy and Safety of SPN-812 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)",COMPLETED,,PHASE3,374.0,ACTUAL,"Supernus Pharmaceuticals, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,INDUSTRY,,,,,,,2020,1.0
NCT02231879,,2014-09-03,2021-12-23,,2023-04-06,2014-09-03,2014-09-04,ESTIMATED,2023-04-06,2023-04-07,ACTUAL,,,,2023-04-06,2023-04-07,ACTUAL,2014-10-14,ACTUAL,2014-10-14,2021-03,2021-03-31,2021-02-24,ACTUAL,2021-02-24,2020-10-08,ACTUAL,2020-10-08,,INTERVENTIONAL,,,Plerixafor Versus G-CSF in the Treatment of People With WHIM Syndrome,A Phase III Double-Blind Randomized Crossover Study of Plerixafor Versus G-CSF in the Treatment of Patients With WHIM Syndrome.,COMPLETED,,PHASE2/PHASE3,20.0,ACTUAL,National Institutes of Health Clinical Center (CC),"1. Highly variable disease phenotypic expression made crossover design optimal but a placebo arm was not included due to infection risk of severe neutropenia~2. Prophylactic supplemental immunoglobulin and antibiotics were allowed~3. Tolerance of G-CSF was insured prior to randomization but plerixafor was never used before randomization in 17/19 patients,~4. Non-inferiority analysis of primary endpoint was not planned because there were no defined equivalence margins",2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 22:07:27.6665,2024-10-16 22:07:27.6665,NIH,,,,,,,2021,1.0
NCT03396315,,2018-01-05,2024-04-16,,2024-04-16,2018-01-05,2018-01-10,ACTUAL,2024-04-16,2024-05-08,ACTUAL,,,,2024-04-16,2024-05-08,ACTUAL,2018-01-29,ACTUAL,2018-01-29,2024-04,2024-04-30,2023-06-09,ACTUAL,2023-06-09,2023-06-09,ACTUAL,2023-06-09,,INTERVENTIONAL,,,Bisphosphonates for Prevention of Post-Denosumab Bone Loss,Bisphosphonates for Prevention of Post-Denosumab Bone Loss in Premenopausal Women With Idiopathic Osteoporosis,COMPLETED,,PHASE2,24.0,ACTUAL,Columbia University,,2.0,,,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,OTHER,,,,,,,2023,1.0
NCT04438902,,2020-06-15,,,2023-02-17,2020-06-17,2020-06-19,ACTUAL,,,,,,,2023-02-17,2023-02-21,ACTUAL,2020-12-12,ACTUAL,2020-12-12,2021-06,2021-06-30,2023-02-16,ACTUAL,2023-02-16,2022-12-08,ACTUAL,2022-12-08,,INTERVENTIONAL,,,Osimertinib Combined With Anlotinib in EGFR T790M Mutated NSCLC Patients With Progression on Osimertinib Treatment,"A Prospective, Multi-center, Interventional Study of Osimertinib Combined With Anlotinib in Acquired EGFR T790M Mutated NSCLC Patients With Gradual Progression on Osimertinib Treatment",TERMINATED,,PHASE2,3.0,ACTUAL,First Affiliated Hospital of Zhejiang University,,1.0,,Many patients can't tolerate the combination treatment due to adverse events.,f,,,,f,f,f,,,,,,,,,NO,No plan to share participant data of the trial.,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,OTHER,,,,,,,2023,0.0
NCT05007808,,2021-07-22,2024-02-26,,2024-03-26,2021-08-09,2021-08-16,ACTUAL,2024-03-26,2024-04-23,ACTUAL,,,,2024-03-26,2024-04-23,ACTUAL,2021-01-06,ACTUAL,2021-01-06,2024-03,2024-03-31,2023-01-10,ACTUAL,2023-01-10,2023-01-04,ACTUAL,2023-01-04,,INTERVENTIONAL,,,Efficacy and Safety of G001 in Patients With Osteoarthritis (OA) of the Knee,"Phase 2 Multicenter, Double-blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate the Efficacy, Safety, and Local Tolerability of G001 in Patients With Osteoarthritis (OA) of the Knee",COMPLETED,,PHASE2,210.0,ACTUAL,BUZZZ Pharmaceuticals Limited,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2023,1.0
NCT05216055,,2022-01-04,,,2023-03-03,2022-01-25,2022-01-31,ACTUAL,,,,,,,2023-03-03,2023-03-06,ACTUAL,2022-04-19,ACTUAL,2022-04-19,2023-03,2023-03-31,2022-12-27,ACTUAL,2022-12-27,2022-12-16,ACTUAL,2022-12-16,,INTERVENTIONAL,TAP,,Transverse Abdominus Plane Block Study,Effect of Laparoscopic-Guided Transversus Abdominus Plane (TAP) Block on Opioid Consumption Using Dual-Adjunct Therapy With Dexmedetomidine and Dexamethasone Versus Liposomal Bupivacaine (Exparel®) Following Minimally Invasive Colorectal Surgery: A Single-Blinded Randomized Clinical Trial.,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of Colorado, Denver",,2.0,,No Accrual. PI left Institution,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,OTHER,,,,,,,2022,0.0
NCT04250597,,2020-01-27,,,2024-05-03,2020-01-30,2020-01-31,ACTUAL,,,,,,,2024-05-03,2024-05-06,ACTUAL,2020-07-29,ACTUAL,2020-07-29,2024-05,2024-05-31,2023-07-26,ACTUAL,2023-07-26,2023-07-26,ACTUAL,2023-07-26,,INTERVENTIONAL,,,Study of GNX102 in Patients With Advanced Solid Tumors,A Phase I Study of GNX102 in Patients With Advanced Solid Tumors,TERMINATED,,PHASE1,46.0,ACTUAL,"GlycoNex, Inc.",,3.0,,Maximum tolerated dose reached; expansion phase not performed per Sponsor business decision.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,INDUSTRY,,,,,,,2023,0.0
NCT03929757,,2019-04-25,2023-05-25,2021-12-07,2023-10-11,2019-04-25,2019-04-29,ACTUAL,2023-05-25,2023-06-22,ACTUAL,2021-12-07,2021-12-10,ACTUAL,2023-10-11,2023-10-13,ACTUAL,2019-08-19,ACTUAL,2019-08-19,2023-10,2023-10-31,2022-09-28,ACTUAL,2022-09-28,2022-08-22,ACTUAL,2022-08-22,,INTERVENTIONAL,,,A Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in Infants,"A Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of a Heterologous 2-dose Vaccination Regimen Using Ad26.ZEBOV and MVA-BN®-Filo in Infants Aged 4-11 Months in Guinea and Sierra Leone",COMPLETED,,PHASE2,108.0,ACTUAL,Janssen Vaccines & Prevention B.V.,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2022,1.0
NCT03737474,,2018-07-29,2023-01-17,,2023-11-14,2018-11-07,2018-11-09,ACTUAL,2023-11-14,2024-04-29,ACTUAL,,,,2023-11-14,2024-04-29,ACTUAL,2018-10-04,ACTUAL,2018-10-04,2023-11,2023-11-30,2021-04-13,ACTUAL,2021-04-13,2021-03-17,ACTUAL,2021-03-17,,INTERVENTIONAL,,"This trial was conducted in 248 participants in Japan. Of the 248 subjects who were administered investigational medicinal product, the efficacy analysis set and the safety analysis set comprised 247 subjects (216 rollover subjects, 31 newly enrolled subjects) of the total brexpiprazole population.",A Long-Term Study of Brexpiprazole in Patients With Major Depressive Disorder,"A Multi-center, Open-label Trial to Assess the Long-term Safety and Efficacy of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive Disorder",COMPLETED,,PHASE3,248.0,ACTUAL,"Otsuka Pharmaceutical Co., Ltd.",,1.0,,,f,,,,f,f,f,,,,,,"Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.",Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.,,YES,Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,INDUSTRY,,,,,,,2021,1.0
NCT03541187,,2018-05-07,2023-02-21,,2023-05-18,2018-05-17,2018-05-30,ACTUAL,2023-05-18,2023-05-22,ACTUAL,,,,2023-05-18,2023-05-22,ACTUAL,2018-07-16,ACTUAL,2018-07-16,2023-05,2023-05-31,2022-06-03,ACTUAL,2022-06-03,2022-06-02,ACTUAL,2022-06-02,,INTERVENTIONAL,CRITICAL,Intent-to-treat population with available data,Cockroach Immunotherapy in Children and Adolescents,Cockroach Immunotherapy in Children and Adolescents,COMPLETED,,PHASE2,82.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,t,t,f,,,,,,The aim is to share data with the public within 24 months upon completion of the study.,ImmPort public data access.,http://www.immport.org/immport-open/public/home/home,YES,"Participant level data access will be made available to the public at some point in the future via the mechanism of the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.",2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,NIH,,,,,,,2022,1.0
NCT05268744,,2022-02-24,2024-01-04,,2024-01-31,2022-02-24,2022-03-07,ACTUAL,2024-01-31,2024-02-29,ACTUAL,,,,2024-01-31,2024-02-29,ACTUAL,2022-11-14,ACTUAL,2022-11-14,2024-01,2024-01-31,2023-01-30,ACTUAL,2023-01-30,2023-01-14,ACTUAL,2023-01-14,,INTERVENTIONAL,,,Micronutrient Supplementation in Children With ASD,Micronutrient Supplementation in Children With Autism Spectrum Disorder (ASD): A Clinical Trial Examining Mechanism of Action,COMPLETED,,PHASE2,16.0,ACTUAL,"University of California, San Francisco","The limited sample size (N=11) has indeed constrained the statistical power of the analysis.~The absence of a control group prevents direct comparisons between treated participants and untreated individuals, limiting our ability to isolate the effects of the micronutrient supplement from other confounding factors.~We do not have information regarding the types of diets the participants were on which could have influenced their response to the micronutrient supplementation.",1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,OTHER,,,,,,,2023,1.0
NCT01945775,,2013-09-11,2018-09-05,,2021-12-20,2013-09-16,2013-09-19,ESTIMATED,2018-09-05,2018-10-03,ACTUAL,,,,2021-12-20,2022-01-20,ACTUAL,2013-10-14,ACTUAL,2013-10-14,2021-12,2021-12-31,2021-03-05,ACTUAL,2021-03-05,2017-09-15,ACTUAL,2017-09-15,,INTERVENTIONAL,EMBRACA,Intent-to-treat (ITT) analysis population included all randomized participants.,"A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)","A PHASE 3, OPEN-LABEL, RANDOMIZED PARALLEL,2-ARM,MULTI-CENTER STUDY OF TALAZOPARIB(BMN 673) VERSUS PHYSICIAN'S CHOICE IN GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY REGIMENS FOR METASTATIC DISEASE",COMPLETED,,PHASE3,431.0,ACTUAL,Pfizer,,2.0,,,f,,,,f,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,INDUSTRY,,,,,,,2021,1.0
NCT04988997,,2021-07-19,,,2022-12-16,2021-08-02,2021-08-04,ACTUAL,,,,,,,2022-12-16,2022-12-20,ACTUAL,2021-06-14,ACTUAL,2021-06-14,2022-12,2022-12-31,2022-08-24,ACTUAL,2022-08-24,2022-08-05,ACTUAL,2022-08-05,,INTERVENTIONAL,,,VIBRANT Study of Vurolenatide in Adult Patients With Short Bowel Syndrome.,"A Phase 2, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study of the Efficacy, Safety, and Tolerability of Vurolenatide in Adult Patients With Short Bowel Syndrome",TERMINATED,,PHASE2,12.0,ACTUAL,"9 Meters Biopharma, Inc.",,4.0,,Trial terminated by Sponsor,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,INDUSTRY,,,,,,,2022,0.0
NCT03164083,,2017-05-21,,,2020-03-16,2017-05-21,2017-05-23,ACTUAL,,,,,,,2020-03-16,2020-03-18,ACTUAL,2019-11-10,ESTIMATED,2019-11-10,2019-01,2019-01-31,2020-12-05,ESTIMATED,2020-12-05,2020-08-21,ESTIMATED,2020-08-21,,INTERVENTIONAL,,,The Effects of Stromal Vascular Fraction and Mesenchymal Stem Cells as Intra-articular Injection in Knee Joint Osteoarthritis,"Evaluation the Effects of Intra-articular Injection of Mesenchymal Stem Cells and Stromal Vascular Fraction Patients With Knee Joint Osteoarthritis, Triple Blind Randomized Clinical Trial",WITHDRAWN,,PHASE2,0.0,ACTUAL,"SCARM Institute, Tabriz, Iran",,2.0,,not approved by sponsor,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,OTHER_GOV,,,,,,,2020,0.0
NCT02533141,,2015-08-24,,,2020-02-19,2015-08-25,2015-08-26,ESTIMATED,,,,,,,2020-02-19,2020-02-20,ACTUAL,2019-10,ESTIMATED,2019-10-31,2020-02,2020-02-29,2020-12,ESTIMATED,2020-12-31,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,Effect of Simvastatin Withdrawal on Ocular Endothelial Function,Effect of Simvastatin Withdrawal on Ocular Endothelial Function,WITHDRAWN,,PHASE4,0.0,ACTUAL,Medical University of Vienna,,2.0,,no funding,f,,,,f,f,f,,,,,,,,,,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,OTHER,,,,,,,2020,0.0
NCT03393702,,2017-12-28,,,2021-08-31,2018-01-05,2018-01-08,ACTUAL,,,,,,,2021-08-31,2021-09-08,ACTUAL,2017-05-09,ACTUAL,2017-05-09,2021-08,2021-08-31,2020-12-03,ACTUAL,2020-12-03,2019-12-30,ACTUAL,2019-12-30,,INTERVENTIONAL,,,Pain Control in Children and Adolescent After Thoracic Surgery: The Effect of Gabapentin,Efficacy of Gabapentin as Adjuvant for Postoperative Pain in Pediatric Thoracic Surgery - a Randomized Quadruple Blind Study,COMPLETED,,PHASE4,104.0,ACTUAL,"National Institute for Tuberculosis and Lung Diseases, Poland",,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,OTHER,,,,,,,2020,1.0
NCT04241744,,2020-01-21,,,2020-01-24,2020-01-24,2020-01-27,ACTUAL,,,,,,,2020-01-24,2020-01-27,ACTUAL,2019-10-29,ACTUAL,2019-10-29,2020-01,2020-01-31,2020-01-13,ACTUAL,2020-01-13,2020-01-13,ACTUAL,2020-01-13,,INTERVENTIONAL,,,Prospective Trial of Oral Vancomycin Therapy vs. Placebo for Prevention of CDI,"Prospective, Randomized, Double-Blind, Trial of Oral Vancomycin Therapy Compared to Placebo As Primary Prevention for C. Difficile-associated Infection (CDI)",WITHDRAWN,,PHASE4,0.0,ACTUAL,Creighton University,,2.0,,difficulty enrolling patients,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,OTHER,,,,,,,2020,0.0
NCT01366612,,2011-06-02,2022-11-18,,2023-06-09,2011-06-03,2011-06-06,ESTIMATED,2022-11-18,2022-12-16,ACTUAL,,,,2023-06-09,2023-06-13,ACTUAL,2010-06-16,ACTUAL,2010-06-16,2023-06,2023-06-30,2020-08-18,ACTUAL,2020-08-18,2020-08-17,ACTUAL,2020-08-17,,INTERVENTIONAL,FLUBUTBI,"Of the 53 consented, Forty-Seven patients with myeloid diseases were randomized into Flu/Bu4 (25 patients) or Flu/Bu4/TBI (22 patients)","PRO#1278: Fludarabine and Busulfan vs. Fludarabine, Busulfan and Total Body Irradiation","PRO#1278: A Phase III Study of Fludarabine and Busulfan Versus Fludarabine, Busulfan and Low Dose Total Body Irradiation in Patients Receiving an Allogeneic Hematopoietic Stem Cell Transplant",TERMINATED,,PHASE3,53.0,ACTUAL,Hackensack Meridian Health,,2.0,,Lack of Accrual,f,,,,t,,,,,,,,,,,,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,OTHER,,,,,,,2020,0.0
NCT03831945,,2019-02-05,2021-08-02,,2021-09-22,2019-02-05,2019-02-06,ACTUAL,2021-09-22,2021-10-12,ACTUAL,,,,2021-09-22,2021-10-12,ACTUAL,2019-04-04,ACTUAL,2019-04-04,2021-08,2021-08-31,2020-12-08,ACTUAL,2020-12-08,2020-12-08,ACTUAL,2020-12-08,,INTERVENTIONAL,,,Combination Therapy With VRC01 and 10-1074 in HIV-Infected Individuals Undergoing Sequential Treatment Interruptions,An Exploratory Study of Combination Therapy With VRC-HIVMAB060-00-AB (VRC01) and 10-1074 in HIVInfected Individuals Undergoing Sequential Treatment Interruptions,TERMINATED,,PHASE1,27.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,unable to recruit due to COVID pandemic,f,,,,,t,f,,,,,,,,,,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,NIH,,,,,,,2020,0.0
NCT02066285,,2014-02-14,,,2023-03-24,2014-02-17,2014-02-19,ESTIMATED,,,,,,,2023-03-24,2023-03-27,ACTUAL,2014-06,ACTUAL,2014-06-30,2023-03,2023-03-31,2023-03-24,ACTUAL,2023-03-24,2019-12,ACTUAL,2019-12-31,,INTERVENTIONAL,,,Trial of Pazopanib in Patients With Solitary Fibrous Tumor and Extraskeletal Myxoid Chondrosarcoma,A Phase II Open-Label Trial of Pazopanib Administered as a Single Agent in Patients With Unresectable or Metastatic Solitary Fibrous Tumor (SFT) and Extraskeletal Myxoid Chondrosarcoma (EMC),COMPLETED,,PHASE2,96.0,ACTUAL,Grupo Espanol de Investigacion en Sarcomas,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 01:03:03.76992,2024-10-16 01:03:03.76992,OTHER,,,,,,,2023,1.0
NCT00316888,,2006-04-19,2016-07-18,,2023-06-15,2006-04-19,2006-04-21,ESTIMATED,2016-07-18,2016-08-29,ESTIMATED,,,,2023-06-15,2023-06-29,ACTUAL,2007-02-28,ACTUAL,2007-02-28,2023-06,2023-06-30,2021-08-17,ACTUAL,2021-08-17,2015-11,ACTUAL,2015-11-30,,INTERVENTIONAL,,all eligible and treated patients,"Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer","Phase II Trial of Cetuximab Plus Cisplatin, 5- Fluorouracil and Radiation in Immunocompetent Patients With Anal Carcinoma",COMPLETED,,PHASE2,63.0,ACTUAL,Eastern Cooperative Oncology Group,,2.0,,,f,,,,f,,,,,,,,,,,YES,Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,NETWORK,,,,,,,2021,1.0
NCT04384107,,2020-05-11,2022-09-06,,2023-07-20,2020-05-11,2020-05-12,ACTUAL,2022-10-26,2022-11-15,ACTUAL,,,,2023-07-20,2023-07-28,ACTUAL,2020-07-01,ACTUAL,2020-07-01,2023-07,2023-07-31,2021-12-01,ACTUAL,2021-12-01,2021-12-01,ACTUAL,2021-12-01,,INTERVENTIONAL,,,"Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)","A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants",COMPLETED,,PHASE3,694.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,f,t,f,,,t,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,INDUSTRY,,,,,,,2021,1.0
NCT05174065,,2021-12-14,,2024-04-19,2024-06-26,2021-12-14,2021-12-30,ACTUAL,,,,,2024-02-01,ACTUAL,2024-06-26,2024-06-28,ACTUAL,2022-03-08,ACTUAL,2022-03-08,2024-06,2024-06-30,2024-06-01,ACTUAL,2024-06-01,2023-08-19,ACTUAL,2023-08-19,,INTERVENTIONAL,,,"Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Apremilast (AMG 407) in Japanese Subjects With Palmoplantar Pustulosis (PPP)",COMPLETED,,PHASE3,176.0,ACTUAL,Amgen,,2.0,,,f,,,,f,t,f,,,t,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,INDUSTRY,,,,,,,2024,0.0
NCT03559699,,2018-03-26,2021-11-12,,2021-12-14,2018-06-06,2018-06-18,ACTUAL,2021-11-12,2021-12-10,ACTUAL,,,,2021-12-14,2022-01-04,ACTUAL,2018-06-26,ACTUAL,2018-06-26,2021-12,2021-12-31,2020-11-12,ACTUAL,2020-11-12,2020-11-12,ACTUAL,2020-11-12,,INTERVENTIONAL,,Full analysis set included all participants who received at least 1 dose of study drug.,A Study Evaluating the Efficacy and Safety of AG-348 in Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD),An Open-Label Study To Evaluate the Efficacy and Safety of AG-348 in Regularly Transfused Adult Subjects With Pyruvate Kinase (PK) Deficiency,COMPLETED,,PHASE3,27.0,ACTUAL,"Agios Pharmaceuticals, Inc.",,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,INDUSTRY,,,,,,,2020,1.0
NCT04018599,,2019-07-11,,,2020-03-23,2019-07-11,2019-07-12,ACTUAL,,,,,,,2020-03-23,2020-03-25,ACTUAL,2019-07-15,ACTUAL,2019-07-15,2020-03,2020-03-31,2020-03-17,ACTUAL,2020-03-17,2020-03-17,ACTUAL,2020-03-17,,INTERVENTIONAL,,,Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS,"A Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy Subjects",COMPLETED,,PHASE1,216.0,ACTUAL,Fresenius Kabi SwissBioSim GmbH,,2.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,INDUSTRY,,,,,,,2020,1.0
NCT04594070,,2020-09-30,2024-04-05,,2024-06-18,2020-10-14,2020-10-20,ACTUAL,2024-06-18,2024-06-24,ACTUAL,,,,2024-06-18,2024-06-24,ACTUAL,2020-10-27,ACTUAL,2020-10-27,2024-06,2024-06-30,2024-01-12,ACTUAL,2024-01-12,2024-01-12,ACTUAL,2024-01-12,,INTERVENTIONAL,,,Daily Versus Alternate Day Iron Supplementation for the Treatment of Iron Deficiency Anemia in Pregnancy,A Randomized Trial of Intermittent Oral Iron Supplementation vs. Daily Oral Iron Supplementation for the Treatment of Anemia in Pregnancy,TERMINATED,,PHASE4,14.0,ACTUAL,"The University of Texas Medical Branch, Galveston",,2.0,,Unable to recruit enough participants,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,OTHER,,,,,,,2024,0.0
NCT02720744,,2016-03-22,2022-01-06,,2022-03-18,2016-03-25,2016-03-28,ESTIMATED,2022-03-18,2022-03-22,ACTUAL,,,,2022-03-18,2022-03-22,ACTUAL,2016-11-17,ACTUAL,2016-11-17,2022-03,2022-03-31,2020-03-25,ACTUAL,2020-03-25,2020-03-25,ACTUAL,2020-03-25,,INTERVENTIONAL,,,Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy,"A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects With Narcolepsy",COMPLETED,,PHASE3,212.0,ACTUAL,Avadel,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,INDUSTRY,,,,,,,2020,1.0
NCT04386811,,2020-05-07,,,2024-02-05,2020-05-11,2020-05-13,ACTUAL,,,,,,,2024-02-05,2024-02-07,ACTUAL,2020-08-05,ACTUAL,2020-08-05,2024-02,2024-02-29,2020-09-29,ACTUAL,2020-09-29,2020-09-29,ACTUAL,2020-09-29,,INTERVENTIONAL,,,Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD: a Proof-of-concept Tele-health Study of Stimulant-induced Improvement in Neurocognitive Functioning.,Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD: a Proof-of-concept Tele-health Study of Stimulant-induced Improvement in Neurocognitive Functioning.,TERMINATED,,PHASE1,3.0,ACTUAL,Yale University,,2.0,,"Following Yale University resuming in-person research activities, the investigators no longer had dedicated funding for the study and were unable to secure additional funding to meet the research goals.",f,,,,f,f,f,,,f,,,,,,UNDECIDED,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,OTHER,,,,,,,2020,0.0
NCT03180684,,2017-06-06,2023-07-14,2021-07-16,2023-08-23,2017-06-06,2017-06-08,ACTUAL,2023-08-23,2023-08-25,ACTUAL,,2023-08-25,ACTUAL,2023-08-23,2023-08-25,ACTUAL,2017-08-31,ACTUAL,2017-08-31,2023-08,2023-08-31,2020-12-18,ACTUAL,2020-12-18,2020-07-23,ACTUAL,2020-07-23,,INTERVENTIONAL,,mITT population included all participants who received at least 1 dose of VGX-3100 + EP (with or without imiquimod) and had an analysis endpoint of interest.,Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL (Also Referred as: VIN 2 or VIN 3),"A Phase 2, Randomized, Open Label, Efficacy Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™ 2000 Alone or in Combination With Imiquimod, for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Vulva",COMPLETED,,PHASE2,33.0,ACTUAL,Inovio Pharmaceuticals,,2.0,,,f,,,,t,t,t,,,,,,,,,NO,,2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,INDUSTRY,,,,,,,2020,1.0
NCT04066790,,2019-08-19,,,2020-05-16,2019-08-22,2019-08-26,ACTUAL,,,,,,,2020-05-16,2020-05-19,ACTUAL,2019-09-09,ACTUAL,2019-09-09,2020-05,2020-05-31,2020-04-30,ACTUAL,2020-04-30,2020-04-30,ACTUAL,2020-04-30,,INTERVENTIONAL,,,Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer,"A Randomised, Multicenter, Open-label, Phase II Study Evaluating Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in Early Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2 - Positive Breast Cancer",TERMINATED,,PHASE2,12.0,ACTUAL,Shanghai Jiao Tong University School of Medicine,,2.0,,We terminated this trial and initiated a new one including pertuzumab.,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,OTHER,,,,,,,2020,0.0
NCT04583956,,2020-10-09,2022-09-13,,2023-05-12,2020-10-09,2020-10-12,ACTUAL,2022-11-23,2022-12-19,ACTUAL,,,,2023-05-12,2023-05-16,ACTUAL,2020-10-23,ACTUAL,2020-10-23,2021-09,2021-09-30,2021-09-13,ACTUAL,2021-09-13,2021-09-13,ACTUAL,2021-09-13,,INTERVENTIONAL,,The intention-to-treat (ITT) population includes all participants who were enrolled and randomized.,ACTIV-5 / Big Effect Trial (BET-A) for the Treatment of COVID-19,A Multicenter Platform Trial of Putative Therapeutics for the Treatment of COVID-19 in Hospitalized Adults,COMPLETED,,PHASE2,214.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-15 01:15:09.927277,2024-10-15 01:15:09.927277,NIH,,,,,,,2021,1.0
NCT03019796,,2016-12-31,2020-09-09,,2021-05-18,2017-01-10,2017-01-13,ESTIMATED,2021-05-16,2021-05-18,ACTUAL,,,,2021-05-18,2021-06-14,ACTUAL,2015-07,ACTUAL,2015-07-31,2021-05,2021-05-31,2020-08,ACTUAL,2020-08-31,2018-04,ACTUAL,2018-04-30,,INTERVENTIONAL,METSYND,"The baseline trial is the non-medicated, no-exercise",Exercise Training Effects on Metabolic Syndrome: Interactions With Medication,Effects of Exercise Training as a Non-pharmacological Treatment for Metabolic Syndrome and Its Interactions With Subjects Habitual Medications.,COMPLETED,,EARLY_PHASE1,40.0,ACTUAL,University of Castilla-La Mancha,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,OTHER,,,,,,,2020,1.0
NCT03087019,,2017-03-13,2021-02-26,,2022-10-08,2017-03-21,2017-03-22,ACTUAL,2021-03-29,2021-04-22,ACTUAL,,,,2022-10-08,2022-10-14,ACTUAL,2017-04-25,ACTUAL,2017-04-25,2022-10,2022-10-31,2020-08-04,ACTUAL,2020-08-04,2020-08-04,ACTUAL,2020-08-04,,INTERVENTIONAL,,,Pembrolizumab With or Without Radiation in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma,A Phase II Trial of Pembrolizumab With or Without Radiation in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma,COMPLETED,,PHASE2,21.0,ACTUAL,Dana-Farber Cancer Institute,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,OTHER,,,,,,,2020,1.0
NCT04161495,,2019-11-05,2023-01-25,,2023-04-28,2019-11-11,2019-11-13,ACTUAL,2023-04-28,2023-05-24,ACTUAL,,,,2023-04-28,2023-05-24,ACTUAL,2019-11-19,ACTUAL,2019-11-19,2023-04,2023-04-30,2022-02-03,ACTUAL,2022-02-03,2022-02-03,ACTUAL,2022-02-03,,INTERVENTIONAL,XTEND-1,,"A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A","A Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients ≥12 Years of Age With Severe Hemophilia A",COMPLETED,,PHASE3,159.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,INDUSTRY,,,,,,,2022,1.0
NCT03572478,,2018-06-19,2021-01-26,,2021-02-15,2018-06-19,2018-06-28,ACTUAL,2021-01-26,2021-02-12,ACTUAL,,,,2021-02-15,2021-03-09,ACTUAL,2018-08-14,ACTUAL,2018-08-14,2021-02,2021-02-28,2020-10-01,ACTUAL,2020-10-01,2020-02-29,ACTUAL,2020-02-29,,INTERVENTIONAL,,,Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer,A Phase Ib/IIa Study of Rucaparib (PARP Inhibitor) Combined With Nivolumab in Metastatic Castrate - Resistant Prostate Cancer and Advanced/Recurrent Endometrial Cancer,TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,University of Chicago,,4.0,,The study was terminated due to lack of efficacy.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,OTHER,,,,,,,2020,0.0
NCT03426631,,2018-02-02,2020-01-24,,2020-02-11,2018-02-02,2018-02-08,ACTUAL,2020-01-24,2020-02-07,ACTUAL,,,,2020-02-11,2020-02-19,ACTUAL,2017-09-15,ACTUAL,2017-09-15,2020-02,2020-02-29,2020-01-20,ACTUAL,2020-01-20,2019-10-01,ACTUAL,2019-10-01,,INTERVENTIONAL,OsaStimB2,,DAW1033B2 in Obstructive Sleep Apnea,Effect of DAW1033B2 on Obstructive Sleep Apnea,COMPLETED,,PHASE1/PHASE2,13.0,ACTUAL,Brigham and Women's Hospital,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,OTHER,,,,,,,2020,1.0
NCT04754230,,2021-02-10,2023-03-09,,2023-03-09,2021-02-10,2021-02-15,ACTUAL,2023-03-09,2023-04-05,ACTUAL,,,,2023-03-09,2023-04-05,ACTUAL,2021-06-17,ACTUAL,2021-06-17,2023-03,2023-03-31,2022-02-20,ACTUAL,2022-02-20,2022-02-20,ACTUAL,2022-02-20,,INTERVENTIONAL,,,Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery,Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery,COMPLETED,,PHASE4,40.0,ACTUAL,Stanford University,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,No current plan to share data.,2024-10-15 01:15:09.927277,2024-10-15 01:15:09.927277,OTHER,,,,,,,2022,1.0
NCT04540393,,2020-08-26,,,2021-09-27,2020-09-04,2020-09-07,ACTUAL,,,,,,,2021-09-27,2021-10-01,ACTUAL,2020-09-02,ACTUAL,2020-09-02,2021-09,2021-09-30,2022-05-11,ESTIMATED,2022-05-11,2020-12-04,ESTIMATED,2020-12-04,,INTERVENTIONAL,,,AZD1222 Vaccine for the Prevention of COVID-19,"A Phase III Open-label Study in Adults to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19",WITHDRAWN,,PHASE3,0.0,ACTUAL,AstraZeneca,,1.0,,"The study was put on hold in September 2020 due to a safety concern in another trial but never restarted. In the meantime our clinical development program now includes a similar study with a different design, which we prefer to complete now.",f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,INDUSTRY,,,,,,,2022,0.0
NCT02671084,,2016-01-20,,,2020-04-24,2016-01-28,2016-02-02,ESTIMATED,,,,,,,2020-04-24,2020-04-28,ACTUAL,2016-02,ACTUAL,2016-02-29,2020-04,2020-04-30,2020-04,ACTUAL,2020-04-30,2020-04,ACTUAL,2020-04-30,,INTERVENTIONAL,,,Sevoflurane and Percutaneous Coronary Intervention by Stent,Effect of Sevoflurane on CKMB Release After PCI With Drug-eluting Stents: a Randomised Trial,TERMINATED,,PHASE4,701.0,ACTUAL,Instituto Dante Pazzanese de Cardiologia,,2.0,,interim analysis suggests futility,f,,,,t,f,,,,,,,,,,YES,Data will be published in journals,2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,OTHER,,,,,,,2020,0.0
NCT02900560,,2016-09-01,2022-04-26,,2022-05-17,2016-09-08,2016-09-14,ESTIMATED,2022-05-17,2022-06-10,ACTUAL,,,,2022-05-17,2022-06-10,ACTUAL,2016-12-20,ACTUAL,2016-12-20,2022-05,2022-05-31,2021-05-27,ACTUAL,2021-05-27,2021-05-27,ACTUAL,2021-05-27,,INTERVENTIONAL,,,Study of Pembrolizumab With or Without CC-486 in Patients With Platinum-resistant Ovarian Cancer,"Phase II Randomized Study of Pembrolizumab With or Without Epigenetic Modulation With CC-486 in Patients With Platinum-resistant Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer",TERMINATED,,PHASE2,34.0,ACTUAL,Translational Research in Oncology,"Trial closed prematurely with 34 participant enrolled in Part A of the study. All of the treatment cohorts met at least one of the safety rejection criteria. Enrollment took 31 months, significantly longer than anticipated (24 months).",4.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,OTHER,,,,,,,2021,0.0
NCT03761537,,2018-11-30,2021-09-27,2021-03-15,2024-07-23,2018-11-30,2018-12-03,ACTUAL,2021-09-27,2021-10-26,ACTUAL,2021-03-15,2021-03-19,ACTUAL,2024-07-23,2024-08-01,ACTUAL,2018-12-13,ACTUAL,2018-12-13,2023-05,2023-05-31,2020-09-28,ACTUAL,2020-09-28,2020-04-21,ACTUAL,2020-04-21,,INTERVENTIONAL,ECZTRA 7,,Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7,"A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase 3 Trial Investigating the Efficacy, Safety, and Tolerability of Tralokinumab Administered in Combination With Topical Corticosteroids to Adult Subjects With Severe Atopic Dermatitis",COMPLETED,,PHASE3,277.0,ACTUAL,LEO Pharma,,2.0,,,f,,,,,t,f,,,t,,,,De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.,https://www.leopharmatrials.com/en/for-researchers,YES,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,INDUSTRY,,,,,,,2020,1.0
NCT04883528,,2021-05-06,2024-06-06,,2024-06-06,2021-05-11,2021-05-12,ACTUAL,2024-06-06,2024-07-03,ACTUAL,,,,2024-06-06,2024-07-03,ACTUAL,2021-08-06,ACTUAL,2021-08-06,2024-06,2024-06-30,2023-06-13,ACTUAL,2023-06-13,2023-06-13,ACTUAL,2023-06-13,,INTERVENTIONAL,PARACOR-19,,Protecting With ARNI Against Cardiac Consequences of Coronavirus Disease 2019,Protecting With ARNI Against Cardiac Consequences of Coronavirus Disease 2019,COMPLETED,,PHASE1/PHASE2,42.0,ACTUAL,Duke University,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,OTHER,,,,,,,2023,1.0
NCT01506609,,2012-01-06,2021-09-27,2019-11-12,2021-09-27,2012-01-09,2012-01-10,ESTIMATED,2021-09-27,2021-10-25,ACTUAL,2019-11-12,2019-11-15,ACTUAL,2021-09-27,2021-10-25,ACTUAL,2012-01-23,ACTUAL,2012-01-23,2021-09,2021-09-30,2020-09-02,ACTUAL,2020-09-02,2018-12-13,ACTUAL,2018-12-13,,INTERVENTIONAL,,,Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer,"A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer",COMPLETED,,PHASE2,294.0,ACTUAL,AbbVie,,3.0,,,t,,,,t,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,INDUSTRY,,NCT03123211,NO_LONGER_AVAILABLE,,,,2020,1.0
NCT04023071,,2019-07-09,,,2023-10-25,2019-07-15,2019-07-17,ACTUAL,,,,,,,2023-10-25,2023-10-26,ACTUAL,2019-10-04,ACTUAL,2019-10-04,2023-10,2023-10-31,2023-10-23,ACTUAL,2023-10-23,2023-10-23,ACTUAL,2023-10-23,,INTERVENTIONAL,,,FT516 in Subjects With Advanced Hematologic Malignancies,A Phase I Study of FT516 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory B-Cell Lymphoma,TERMINATED,,PHASE1,72.0,ACTUAL,Fate Therapeutics,,4.0,,The study was terminated by the Sponsor.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,INDUSTRY,,,,,,,2023,0.0
NCT04119453,,2019-09-24,,2024-06-21,2024-06-21,2019-10-07,2019-10-08,ACTUAL,,,,,2024-06-24,ACTUAL,2024-06-21,2024-06-24,ACTUAL,2020-01-22,ACTUAL,2020-01-22,2024-06,2024-06-30,2023-06-28,ACTUAL,2023-06-28,2023-06-28,ACTUAL,2023-06-28,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of Rivoceranib in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC),"A Phase 2 Open-Label, Multicenter, Study to Evaluate the Efficacy and Safety of Rivoceranib in Subjects With Recurrent or Metastatic Adenoid Cystic Carcinoma of All Anatomic Sites of Origin",TERMINATED,,PHASE2,80.0,ACTUAL,Elevar Therapeutics,,1.0,,The RM-202 study was terminated by the Sponsor due to redirection of the rivoceranib development plan.,f,,,,,t,f,,,,,,,,,,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,INDUSTRY,,,,,,,2023,0.0
NCT03883113,,2019-02-21,2020-12-04,,2021-03-17,2019-03-18,2019-03-20,ACTUAL,2021-03-17,2021-03-18,ACTUAL,,,,2021-03-17,2021-03-18,ACTUAL,2019-06-03,ACTUAL,2019-06-03,2021-03,2021-03-31,2020-04-17,ACTUAL,2020-04-17,2019-12-16,ACTUAL,2019-12-16,,INTERVENTIONAL,,,Efficacy of MVA-NP+M1 in the Influenza H3N2 Human Challenge Model,Efficacy of MVA-NP+M1 in the Influenza H3N2 Human Challenge Model,COMPLETED,,PHASE2,145.0,ACTUAL,Barinthus Biotherapeutics,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,INDUSTRY,,,,,,,2020,1.0
NCT04054752,,2019-08-10,,,2023-11-01,2019-08-10,2019-08-13,ACTUAL,,,,,,,2023-11-01,2023-11-02,ACTUAL,2023-05-30,ACTUAL,2023-05-30,2023-11,2023-11-30,2023-11-01,ACTUAL,2023-11-01,2023-11-01,ACTUAL,2023-11-01,,INTERVENTIONAL,,,Vaccine Response With NT-I7,A Phase 1/1b Study of Enhancement of Immune Reconstitution and Vaccine Responses With Administration of Recombinant Human IL-7-hyFc (NT-I7) in Older Subjects Following Chemotherapy,WITHDRAWN,,PHASE1,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,No subjects enrolled.,f,,,,,t,f,,,,,,Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.,Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.,,YES,".All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGAP.",2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,NIH,,,,,,,2023,0.0
NCT04176016,,2019-11-20,,,2024-01-31,2019-11-21,2019-11-25,ACTUAL,,,,,,,2024-01-31,2024-02-02,ACTUAL,2020-01-10,ACTUAL,2020-01-10,2024-01,2024-01-31,2024-01-11,ACTUAL,2024-01-11,2024-01-11,ACTUAL,2024-01-11,,INTERVENTIONAL,,,Phase I Study of Radiolabeled OTSA101-DTPA in Patients With Relapsed or Refractory Synovial Sarcoma,"Safety Study of Radiolabeled (111In or 90Y) OTSA101-DTPA, an Anti-Frizzled Homolog 10 (FZD10) Monoclonal Antibody, to Evaluate Safety and Pharmacokinetics in Patients With Relapsed or Refractory Synovial Sarcoma",TERMINATED,,PHASE1,12.0,ACTUAL,"OncoTherapy Science, Inc.",,1.0,,Some of the raw materials for the investigational drug are difficult to obtain and expensive.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,INDUSTRY,,,,,,,2024,0.0
NCT04878484,,2021-03-01,,,2022-08-31,2021-05-05,2021-05-07,ACTUAL,,,,,,,2022-08-31,2022-09-02,ACTUAL,2021-08-11,ACTUAL,2021-08-11,2022-08,2022-08-31,2024-12,ESTIMATED,2024-12-31,2022-10,ESTIMATED,2022-10-31,,INTERVENTIONAL,,,Evaluate TCRT-ESO-A2 Autologous T Cells Expressing TCR Specific for NY-ESO-1 in Subjects With Advanced Solid Tumors,"A Phase 1 Open-label Study to Evaluate the Safety, Tolerability, and Activity of TCRT-ESO-A2 Autologous T Cells Expressing TCR Specific for NY-ESO-1 in Subjects With Advanced Solid Tumors",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Athenex, Inc.",,3.0,,Poor recruitment,f,,,,f,t,f,,,,,,,,,NO,No patients enrolled therefore no data available to share.,2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,INDUSTRY,,,,,,,2024,0.0
NCT03554395,,2018-05-31,,,2020-10-13,2018-05-31,2018-06-13,ACTUAL,,,,,,,2020-10-13,2020-10-19,ACTUAL,2018-04-05,ACTUAL,2018-04-05,2020-05,2020-05-31,2020-08-05,ACTUAL,2020-08-05,2020-05-20,ACTUAL,2020-05-20,,INTERVENTIONAL,,,Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Gastric Cancer,Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Gastric Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Fuda Cancer Hospital, Guangzhou",,3.0,,No participants enrolled,f,,,,f,f,f,,,,,,,,,,,2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,OTHER,,,,,,,2020,0.0
NCT05458375,,2022-07-11,,,2023-05-09,2022-07-11,2022-07-14,ACTUAL,,,,,,,2023-05-09,2023-05-11,ACTUAL,2022-12-29,ACTUAL,2022-12-29,2022-06,2022-06-30,2023-04-26,ACTUAL,2023-04-26,2023-04-26,ACTUAL,2023-04-26,,INTERVENTIONAL,,,Vaginal Estradiol Use in Pessary Care,Vaginal Estradiol Use in Pessary Management: A Randomized Controlled Trial,TERMINATED,,EARLY_PHASE1,11.0,ACTUAL,University of South Florida,,2.0,,"There is a lack of potential study participants at our study site that would meet inclusion criteria, therefore, the study is not feasible and is being terminated.",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,OTHER,,,,,,,2023,0.0
NCT04680949,,2020-12-18,,,2022-09-02,2020-12-22,2020-12-23,ACTUAL,,,,,,,2022-09-02,2022-09-06,ACTUAL,2020-12-23,ACTUAL,2020-12-23,2022-09,2022-09-30,2022-02-06,ACTUAL,2022-02-06,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,SAVE-MORE,,suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19,"suPAR-Guided Anakinra Treatment for Validation of the Risk and Early Management of Severe Respiratory Failure by COVID-19: The SAVE-MORE Double-blind, Randomized, Phase III Confirmatory Trial",COMPLETED,,PHASE3,606.0,ACTUAL,Hellenic Institute for the Study of Sepsis,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 01:15:09.927277,2024-10-15 01:15:09.927277,OTHER,,,,,,,2022,1.0
NCT04555096,,2020-09-16,2022-03-14,,2022-03-14,2020-09-16,2020-09-18,ACTUAL,2022-03-14,2022-03-18,ACTUAL,,,,2022-03-14,2022-03-18,ACTUAL,2020-09-09,ACTUAL,2020-09-09,2022-03,2022-03-31,2021-05-28,ACTUAL,2021-05-28,2021-05-28,ACTUAL,2021-05-28,,INTERVENTIONAL,,Baseline analysis population is the same.,A Trial of GC4419 in Patients With Critical Illness Due to COVID-19,"A Pilot, Randomized, Placebo-Controlled Trial of GC4419 (Avasopasem Manganese) in Patients With Critical Illness Due to SARS-CoV-2 Infection (COVID-19)",TERMINATED,,PHASE2,16.0,ACTUAL,"Galera Therapeutics, Inc.",Study was terminated early due to the inability to enroll critically ill COVID 19 patients as the height of the pandemic was over and the sites that were open for enrollment to the clinical study were no longer treating these types of patients.,2.0,,Participants are no longer receiving intervention,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,INDUSTRY,,,,,,,2021,0.0
NCT05553639,,2022-08-17,,,2024-06-10,2022-09-21,2022-09-23,ACTUAL,,,,,,,2024-06-10,2024-06-12,ACTUAL,2023-05-23,ACTUAL,2023-05-23,2024-06,2024-06-30,2024-04-29,ACTUAL,2024-04-29,2024-04-29,ACTUAL,2024-04-29,,INTERVENTIONAL,,,HB-302/HB-301 Therapy in Participants With Metastatic Castration-Resistant Prostate Cancer,A Phase 1/2 Study of Replicating Arenavirus-based Vector(s) Encoding Prostate Cancer-Associated Antigens in Participants With Metastatic Castration-Resistant Prostate Cancer,TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,Hookipa Biotech GmbH,,1.0,,Decision by the company to terminate the H-300-001 study early for non-safety related reasons.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,INDUSTRY,,,,,,,2024,0.0
NCT02927262,,2016-10-05,2022-04-19,,2024-03-13,2016-10-05,2016-10-07,ESTIMATED,2022-06-03,2022-06-27,ACTUAL,,,,2024-03-13,2024-03-15,ACTUAL,2017-01-10,ACTUAL,2017-01-10,2024-03,2024-03-31,2024-02-19,ACTUAL,2024-02-19,2021-05-25,ACTUAL,2021-05-25,,INTERVENTIONAL,,The full analysis set (FAS) consisted of all participants who were randomized.,"A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission","A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FLT3/ITD AML in First Complete Remission",COMPLETED,,PHASE2,98.0,ACTUAL,Astellas Pharma Inc,,2.0,,,t,,,,t,,,,,,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",http://www.clinicalstudydatarequest.com,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,INDUSTRY,,NCT03070093,APPROVED_FOR_MARKETING,,,,2024,1.0
NCT03767270,,2018-11-28,,,2019-09-12,2018-12-04,2018-12-06,ACTUAL,,,,,,,2019-09-12,2019-09-17,ACTUAL,2019-12,ESTIMATED,2019-12-31,2019-09,2019-09-30,2022-07,ESTIMATED,2022-07-31,2022-07,ESTIMATED,2022-07-31,,INTERVENTIONAL,STEP-OTC,,"Safety, Tolerability and PK/PD Evaluation of Intravenous Administration of MRT5201 in Patients With OTC Deficiency","A Phase 1/2 Single Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered MRT5201 in Subjects With Ornithine Transcarbamylase Deficiency",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Translate Bio, Inc.",,2.0,,Program was discontinued.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,INDUSTRY,,,,,,,2022,0.0
NCT04515849,,2020-07-06,,,2022-03-28,2020-08-11,2020-08-17,ACTUAL,,,,,,,2022-03-28,2022-03-29,ACTUAL,2020-08-31,ACTUAL,2020-08-31,2022-03,2022-03-31,2022-03-08,ACTUAL,2022-03-08,2022-03-08,ACTUAL,2022-03-08,,INTERVENTIONAL,,,A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus,"A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled, and Open-label Comparator Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus",COMPLETED,,PHASE2,247.0,ACTUAL,AstraZeneca,,5.0,,,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,INDUSTRY,,,,,,,2022,0.0
NCT03875482,,2019-03-13,2021-02-19,,2021-02-19,2019-03-13,2019-03-14,ACTUAL,2021-02-19,2021-03-16,ACTUAL,,,,2021-02-19,2021-03-16,ACTUAL,2019-05-13,ACTUAL,2019-05-13,2021-02,2021-02-28,2020-07-15,ACTUAL,2020-07-15,2020-02-20,ACTUAL,2020-02-20,,INTERVENTIONAL,,Intent-to-treat (ITT) population: all randomized participants,A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis",COMPLETED,,PHASE3,157.0,ACTUAL,AbbVie,,2.0,,,f,,,,f,t,f,,,t,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,INDUSTRY,,,,,,,2020,1.0
NCT03781791,,2018-11-27,2023-10-02,,2024-01-31,2018-12-18,2018-12-20,ACTUAL,2023-11-30,2023-12-04,ACTUAL,,,,2024-01-31,2024-02-20,ACTUAL,2018-12-10,ACTUAL,2018-12-10,2024-01,2024-01-31,2021-12-14,ACTUAL,2021-12-14,2021-12-14,ACTUAL,2021-12-14,,INTERVENTIONAL,KARMET,,Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET),"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease-Related Constipation (KARMET)",COMPLETED,,PHASE2,151.0,ACTUAL,Enterin Inc.,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,INDUSTRY,,,,,,,2021,1.0
NCT04390217,,2020-05-13,,,2022-05-09,2020-05-13,2020-05-15,ACTUAL,,,,,,,2022-05-09,2022-05-13,ACTUAL,2021-10-31,ESTIMATED,2021-10-31,2022-05,2022-05-31,2022-03-31,ESTIMATED,2022-03-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia,A Phase 2 Study to Evaluate LB1148 for the Treatment of Pulmonary Dysfunction Associated With COVID-19 Pneumonia,WITHDRAWN,,PHASE2,0.0,ACTUAL,Palisade Bio,,2.0,,Company focused on other clinical programs,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,INDUSTRY,,,,,,,2022,0.0
NCT03644823,,2018-02-06,,,2021-03-25,2018-08-21,2018-08-23,ACTUAL,,,,,,,2021-03-25,2021-03-30,ACTUAL,2018-08-15,ACTUAL,2018-08-15,2021-03,2021-03-31,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,COM-IT-1,,Combinatory ImmunoTherapy-1 (Com-IT-1) Irradiation and PD-1 Blockade in Locally Advanced / Advanced NSCLC,Combinatory ImmunoTherapy-1 (Com-IT-1) Irradiation and PD-1 Blockade in Locally Advanced / Advanced NSCLC,TERMINATED,,PHASE2,21.0,ACTUAL,Oslo University Hospital,,1.0,,slow recruiting,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,OTHER,,,,,,,2020,0.0
NCT04679311,,2020-12-15,2024-01-03,,2024-02-28,2020-12-21,2020-12-22,ACTUAL,2024-02-28,2024-03-27,ACTUAL,,,,2024-02-28,2024-03-27,ACTUAL,2020-12-22,ACTUAL,2020-12-22,2024-02,2024-02-29,2023-01-31,ACTUAL,2023-01-31,2023-01-31,ACTUAL,2023-01-31,,INTERVENTIONAL,,No patients were randomized to the High ACE FFP. Study was terminated due to end of funding period.,Treatment of Angiotensin Converting Enzyme Inhibitor-induced Angioedema,High Angiotensin Converting Enzyme Activity-containing Plasma for the Treatment of Angiotensin Converting Enzyme Inhibitor-induced Angioedema,TERMINATED,,PHASE2,2.0,ACTUAL,Washington University School of Medicine,,2.0,,End of funding period,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,OTHER,,,,,,,2023,0.0
NCT04571645,,2020-09-25,2023-10-23,,2024-03-18,2020-09-30,2020-10-01,ACTUAL,2024-03-18,2024-04-15,ACTUAL,,,,2024-03-18,2024-04-15,ACTUAL,2021-04-30,ACTUAL,2021-04-30,2024-03,2024-03-31,2022-05-16,ACTUAL,2022-05-16,2022-05-16,ACTUAL,2022-05-16,,INTERVENTIONAL,AML,,Dociparstat in Combination With Standard Chemotherapy for the Treatment of Acute Myeloid Leukemia,"A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dociparstat Sodium in Combination With Standard Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia",TERMINATED,,PHASE3,9.0,ACTUAL,Chimerix,"Due to low subject accrual, study enrollment was prematurely terminated on 16 May 2021. Therefore, formal statistical analyses were not performed, and no conclusions can be drawn about dociparstat with regards to efficacy.",2.0,,Study enrollment was terminated on 16 May 2022 due to slow recruitment.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,INDUSTRY,,,,,,,2022,0.0
NCT02805179,,2016-05-12,2021-02-05,,2021-03-21,2016-06-14,2016-06-17,ESTIMATED,2021-03-21,2021-04-15,ACTUAL,,,,2021-03-21,2021-04-15,ACTUAL,2016-09-22,ACTUAL,2016-09-22,2021-03,2021-03-31,2020-11-18,ACTUAL,2020-11-18,2020-02-06,ACTUAL,2020-02-06,,INTERVENTIONAL,,,A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma,Phase II Study of High Dose Radiotherapy and Concurrent Temozolomide Using Biologically-Based Target Volume Definition in Patients With Newly Diagnosed Glioblastoma,COMPLETED,,PHASE2,26.0,ACTUAL,University of Michigan Rogel Cancer Center,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,OTHER,,,,,,,2020,1.0
NCT03191786,,2017-06-15,2023-04-18,,2023-11-01,2017-06-15,2017-06-19,ACTUAL,2023-05-15,2023-05-17,ACTUAL,,,,2023-11-01,2023-11-07,ACTUAL,2017-09-11,ACTUAL,2017-09-11,2023-11,2023-11-30,2023-10-25,ACTUAL,2023-10-25,2022-04-30,ACTUAL,2022-04-30,,INTERVENTIONAL,IPSOS,,A Study of Atezolizumab Compared With a Single-Agent Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Doublet Chemotherapy,"A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab Compared With Chemotherapy in Patients With Treatment Naïve Advanced or Recurrent (Stage IIIb Not Amenable for Multimodality Treatment) or Metastatic (Stage IV) Non-Small Cell Lung Cancer Who Are Deemed Unsuitable for Platinum-Containing Therapy",COMPLETED,,PHASE3,453.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,INDUSTRY,,,,,,,2023,1.0
NCT03064854,,2017-02-06,,,2022-08-11,2017-02-22,2017-02-27,ACTUAL,,,,,,,2022-08-11,2022-08-15,ACTUAL,2017-05-24,ACTUAL,2017-05-24,2022-08,2022-08-31,2021-07-28,ACTUAL,2021-07-28,2021-07-28,ACTUAL,2021-07-28,,INTERVENTIONAL,,,"PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients","Phase Ib, Multicenter, Open Label Study of PDR001 in Combination With Platinum Doublet Chemotherapy and Other Immunooncology Agents in PD-L1 Unselected, Metastatic NSCLS Patients (ElevatION:NSCLC-101 Trial)",TERMINATED,,PHASE1,111.0,ACTUAL,Novartis,,4.0,,Recruitment halted prematurely due to competitive landscape for lung cancer therapies,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,INDUSTRY,,,,,,,2021,0.0
NCT05408871,,2022-06-01,,,2024-02-13,2022-06-01,2022-06-07,ACTUAL,,,,,,,2024-02-13,2024-02-15,ACTUAL,2023-02-21,ACTUAL,2023-02-21,2024-02,2024-02-29,2024-01-31,ACTUAL,2024-01-31,2024-01-31,ACTUAL,2024-01-31,,INTERVENTIONAL,,,Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases,Pilot Study of Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases,TERMINATED,,PHASE1,7.0,ACTUAL,Yale University,,2.0,,PI changed institutions,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:13:41.132594,2024-10-16 22:13:41.132594,OTHER,,,,,,,2024,0.0
NCT03283397,,2017-09-12,,,2024-08-11,2017-09-12,2017-09-14,ACTUAL,,,,,,,2024-08-11,2024-08-13,ACTUAL,2019-03-26,ACTUAL,2019-03-26,2023-02,2023-02-28,2023-07-01,ACTUAL,2023-07-01,2023-07-01,ACTUAL,2023-07-01,,INTERVENTIONAL,,,"A Phase IIIb, Multicenter, International Study to Evaluate the Efficacy, Safety and Tolerability of EK-12 in Patients With RRMS","A Phase IIIb, Multi-center, International, Randomized, Assessor-blind, Active-controlled Parallel Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Neuropeptide Combination of Metenkefalin and Tridecactide (EK-12) in Comparison to Interferon Beta-1a (REBIF®) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)",TERMINATED,,PHASE3,301.0,ACTUAL,Bosnalijek D.D,,2.0,,"During the Covid-19 pandemic, the study was unable to enrol further patients.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,INDUSTRY,,,,,,,2023,0.0
NCT05065567,,2021-09-23,,,2023-11-22,2021-10-01,2021-10-04,ACTUAL,,,,,,,2023-11-22,2023-11-28,ACTUAL,2021-08-30,ACTUAL,2021-08-30,2023-11,2023-11-30,2023-11-20,ACTUAL,2023-11-20,2023-11-20,ACTUAL,2023-11-20,,INTERVENTIONAL,,,"Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis",A Comparison of Haloperidol 5mg IM vs Droperidol 2.5mg and Ondansetron for the Treatment of Hyperemesis in Cannabis Hyperemesis Syndrome,TERMINATED,,PHASE2,38.0,ACTUAL,Spectrum Health - Lakeland,,3.0,,"Lost too many patients to follow up, unable to enroll enough patients",f,,,,,t,f,,,f,,,,,,YES,,2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,OTHER,,,,,,,2023,0.0
NCT05887843,,2023-05-24,,,2023-09-26,2023-05-24,2023-06-05,ACTUAL,,,,,,,2023-09-26,2023-09-28,ACTUAL,2023-06-08,ACTUAL,2023-06-08,2023-09,2023-09-30,2023-09-08,ACTUAL,2023-09-08,2023-09-08,ACTUAL,2023-09-08,,INTERVENTIONAL,,,Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents and Young Adults With Seasonal Allergic Rhinitis,"An Open-label, Single-Dose, Three-way Crossover Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents (12 to 17 Years of Age) and Young Adults (18 to 24 Years of Age) With Seasonal Allergic Rhinitis",TERMINATED,,PHASE1,38.0,ACTUAL,Sandoz,,3.0,,Business decision (no safety concerns).,f,,,,f,f,f,,,,,,,,,,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,INDUSTRY,,,,,,,2023,0.0
NCT01876784,,2013-06-11,2017-01-23,,2024-06-26,2013-06-11,2013-06-13,ESTIMATED,2017-01-23,2017-03-13,ACTUAL,,,,2024-06-26,2024-07-23,ACTUAL,2013-09-17,ACTUAL,2013-09-17,2024-06,2024-06-30,2022-01-22,ACTUAL,2022-01-22,2015-08-30,ACTUAL,2015-08-30,,INTERVENTIONAL,VERIFY,Analysis was performed on all randomized participants.,"Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer","A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Phase III Study to Assess the Efficacy and Safety of Vandetanib (CAPRELSA™; SAR390530 (Formerly AstraZeneca ZD6474)) 300 mg in Patients With Differentiated Thyroid Cancer That Is Either Locally Advanced or Metastatic Who Are Refractory or Unsuitable for Radioiodine (RAI) Therapy",COMPLETED,,PHASE3,238.0,ACTUAL,Sanofi,This study was part of the drug acquisition where model-based PK analysis was not performed by the legacy company. Available PK descriptive statistics have been reported.,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,INDUSTRY,,,,,,,2022,1.0
NCT02949843,,2016-10-27,2024-03-06,,2024-06-26,2016-10-27,2016-10-31,ESTIMATED,2024-06-26,2024-06-28,ACTUAL,,,,2024-06-26,2024-06-28,ACTUAL,2017-03-10,ACTUAL,2017-03-10,2024-06,2024-06-30,2021-01-12,ACTUAL,2021-01-12,2018-01-08,ACTUAL,2018-01-08,,INTERVENTIONAL,,,Targeted Therapy in Treating Patients With Incurable Non-Small Cell Lung Cancer With Genetic Mutations,Phase II Pilot Study Evaluating Strategies to Overcome Resistance at the Time of Progression for Patients With Non-small Cell Lung Cancers Harboring Major Oncogenic Drivers,TERMINATED,,PHASE2,19.0,ACTUAL,Wake Forest University Health Sciences,,3.0,,"Slow accrual, closed by IRB",f,,,,t,t,f,,,f,,,,,,,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,OTHER,,,,,,,2021,0.0
NCT03626545,,2018-07-25,2022-09-02,2021-12-01,2023-08-16,2018-08-08,2018-08-13,ACTUAL,2023-06-20,2023-06-22,ACTUAL,,2023-06-22,ACTUAL,2023-08-16,2023-08-21,ACTUAL,2019-01-23,ACTUAL,2019-01-23,2023-08,2023-08-31,2021-12-20,ACTUAL,2021-12-20,2021-01-08,ACTUAL,2021-01-08,,INTERVENTIONAL,CANOPY-2,,Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy,"A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Canakinumab in Combination With Docetaxel Versus Placebo in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancer (NSCLC) Previously Treated With PD-(L)1 Inhibitors and Platinum-based Chemotherapy (CANOPY 2)",TERMINATED,,PHASE3,245.0,ACTUAL,Novartis,,3.0,,The study was early terminated due to the lack of efficacy of study treatment observed in the analysis of the primary endpoint of the randomized part,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.",2024-10-15 00:47:12.755784,2024-10-15 00:47:12.755784,INDUSTRY,,,,,,,2021,0.0
NCT03689374,,2018-09-27,2022-02-21,,2022-11-10,2018-09-27,2018-09-28,ACTUAL,2022-04-28,2022-05-04,ACTUAL,,,,2022-11-10,2022-11-14,ACTUAL,2018-10-01,ACTUAL,2018-10-01,2022-11,2022-11-30,2021-02-22,ACTUAL,2021-02-22,2021-02-22,ACTUAL,2021-02-22,,INTERVENTIONAL,SUSTAIN 11,Full analysis set included all randomized participants.,"A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes","Effect of Semaglutide Once-weekly Versus Insulin Aspart Three Times Daily, Both as Add on to Metformin and Optimised Insulin Glargine (U100) in Subjects With Type 2 Diabetes A 52-week, Multi-centre, Multinational, Open-label, Active-controlled, Two Armed, Parallel-group, Randomised Trial in Subjects With Type 2 Diabetes",COMPLETED,,PHASE3,2274.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,t,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,INDUSTRY,,,,,,,2021,1.0
NCT05087914,,2021-10-11,,,2024-03-14,2021-10-20,2021-10-21,ACTUAL,,,,,,,2024-03-14,2024-03-18,ACTUAL,2021-11-01,ACTUAL,2021-11-01,2024-03,2024-03-31,2024-01-30,ESTIMATED,2024-01-30,2023-12-30,ESTIMATED,2023-12-30,,INTERVENTIONAL,,,Novel Non-opioid Post-surgical Pain Treatment in Females,Novel Non-opioid Post-surgical Pain Treatment in Females,WITHDRAWN,,PHASE2,0.0,ACTUAL,Northwestern University,,2.0,,"Study was not started, therefore recruitment did not happen",f,,,,f,t,f,,,f,,,,,,YES,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,OTHER,,,,,,,2024,0.0
NCT04051944,,2019-08-08,2022-10-06,,2022-10-06,2019-08-08,2019-08-09,ACTUAL,2022-10-06,2022-11-03,ACTUAL,,,,2022-10-06,2022-11-03,ACTUAL,2019-08-21,ACTUAL,2019-08-21,2022-10,2022-10-31,2021-11-10,ACTUAL,2021-11-10,2021-11-10,ACTUAL,2021-11-10,,INTERVENTIONAL,,Baseline Characteristics refers to the Safety Set (SS) which consisted of all enrolled study participants who were administered at least one dose of rozanolixizumab in CIDP04.,"A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy","An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)",COMPLETED,,PHASE2,21.0,ACTUAL,UCB Pharma,,1.0,,,t,,,,t,t,f,,,f,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",https://vivli.org/,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,INDUSTRY,,NCT05014724,NO_LONGER_AVAILABLE,,,,2021,0.0
NCT06297629,,2024-02-21,,,2024-07-12,2024-03-06,2024-03-07,ACTUAL,,,,,,,2024-07-12,2024-07-15,ACTUAL,2024-07-01,ACTUAL,2024-07-01,2024-07,2024-07-31,2024-07-11,ACTUAL,2024-07-11,2024-07-11,ACTUAL,2024-07-11,,INTERVENTIONAL,,,A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation,A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation,WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,Abandoned,,,,,t,t,f,,,,,,,,,,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,OTHER,,,,,,,2024,0.0
NCT04762225,,2021-02-16,,,2022-12-02,2021-02-18,2021-02-21,ACTUAL,,,,,,,2022-12-02,2022-12-06,ACTUAL,2021-05-10,ACTUAL,2021-05-10,2022-12,2022-12-31,2022-10-11,ACTUAL,2022-10-11,2022-09-14,ACTUAL,2022-09-14,,INTERVENTIONAL,,,RPTR-168 in Patients With Human Papillomavirus Strain 16 (HPV-16) E6/E7 Positive Tumors and Melanoma,A Phase 1/2 Open-Label Multi-Center Study to Characterize the Safety and Tolerability of RPTR-168 in Patients With Relapsed/Refractory HPV-16 E6/E7 Positive Tumors and Melanoma,TERMINATED,,PHASE1,7.0,ACTUAL,Repertoire Immune Medicines,,1.0,,Development program terminated,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,INDUSTRY,,,,,,,2022,0.0
NCT03163277,,2017-05-19,,,2020-11-05,2017-05-22,2017-05-23,ACTUAL,,,,,,,2020-11-05,2020-11-06,ACTUAL,2017-05-15,ACTUAL,2017-05-15,2020-11,2020-11-30,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,(MARAND-X),,Using Less Neurotoxic Drugs in Patients With HAND (MARAND-X),MARaviroc-based Treatment Switch in HIV-positive Patients With HAND: Consequences of Reducing Antiretroviral-associated Neurotoxicity,TERMINATED,,PHASE4,38.0,ACTUAL,"University of Turin, Italy",,2.0,,Sloww accrual and COVID-19 related problems (impossible to perform LPs),f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,OTHER,,,,,,,2020,0.0
NCT02294630,,2014-11-12,2021-03-26,,2021-07-30,2014-11-15,2014-11-19,ESTIMATED,2021-07-30,2021-08-25,ACTUAL,,,,2021-07-30,2021-08-25,ACTUAL,2014-12,,2014-12-31,2021-07,2021-07-31,2020-07,ACTUAL,2020-07-31,2019-07,ACTUAL,2019-07-31,,INTERVENTIONAL,AS-02,,Aerosolized Surfactant in Neonatal RDS,Aerosolized Survanta in Neonatal Respiratory Distress Syndrome: Phase I/II Study,COMPLETED,,PHASE1/PHASE2,159.0,ACTUAL,"Sood, Beena G., MD, MS",,4.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,INDIV,,,,,,,2020,1.0
NCT03498222,,2018-04-06,,,2020-02-24,2018-04-06,2018-04-13,ACTUAL,,,,,,,2020-02-24,2020-02-25,ACTUAL,2018-06-01,ESTIMATED,2018-06-01,2020-02,2020-02-29,2021-12-31,ESTIMATED,2021-12-31,2020-01-31,ESTIMATED,2020-01-31,,INTERVENTIONAL,iTRAP,,"Study in Patients With Tumours Requiring Arginine to Assess ADI-PEG 20 With Atezolizumab, Pemetrexed and Carboplatin","Phase I Study in Patients With Tumours Requiring Arginine to Assess ADI-PEG 20 With Atezolizumab, Pemetrexed and Carboplatin (ADIAtezoPemCarbo) (iTRAP Study)",WITHDRAWN,,PHASE1,0.0,ACTUAL,Queen Mary University of London,,3.0,,Funder and IMP manufacturer withdrew support,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,OTHER,,,,,,,2021,0.0
NCT03655821,,2018-05-14,,,2022-05-09,2018-08-30,2018-08-31,ACTUAL,,,,,,,2022-05-09,2022-05-13,ACTUAL,2019-02-01,ACTUAL,2019-02-01,2022-05,2022-05-31,2021-05-11,ACTUAL,2021-05-11,2021-05-11,ACTUAL,2021-05-11,,INTERVENTIONAL,IMPROVE-II,,Dose Individualization of Pemetrexed - IMPROVE-II,Individualized Pemetrexed Dosing in Patients With Non-small Cell Lung Cancer or Mesothelioma Based on Renal Function to Improve Treatment Response,TERMINATED,,PHASE4,81.0,ACTUAL,Radboud University Medical Center,,2.0,,"81 patients included, difficult inclusion and full inclusion would not change the results",f,,,,f,f,f,,,,,,,,,,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,OTHER,,,,,,,2021,0.0
NCT04596033,,2020-09-30,,,2022-07-13,2020-10-15,2020-10-22,ACTUAL,,,,,,,2022-07-13,2022-07-15,ACTUAL,2020-11-11,ACTUAL,2020-11-11,2022-07,2022-07-31,2022-06-27,ACTUAL,2022-06-27,2022-06-27,ACTUAL,2022-06-27,,INTERVENTIONAL,,,"TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy","A Phase 1 Study to Evaluate the Safety, Proliferation and Persistence of GEN-011, an Autologous Adoptive Cell Therapy Targeting Neoantigens in Solid Tumors",TERMINATED,,PHASE1,49.0,ACTUAL,"Genocea Biosciences, Inc.",,2.0,,Business reasons,f,,,,t,t,f,,,,,,,,,,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,INDUSTRY,,,,,,,2022,0.0
NCT05064449,,2021-09-22,2022-11-28,,2022-11-28,2021-09-22,2021-10-01,ACTUAL,2022-11-28,2023-10-03,ACTUAL,,,,2022-11-28,2023-10-03,ACTUAL,2021-10-14,ACTUAL,2021-10-14,2022-11,2022-11-30,2021-11-30,ACTUAL,2021-11-30,2021-11-21,ACTUAL,2021-11-21,,INTERVENTIONAL,,All participants who received at least one dose of the study drug(s) were included in the safety analysis set.,A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults,"A Phase 1, Open-Label Study to Evaluate the Effect of Itraconazole and Mefenamic Acid on the Single-Dose Pharmacokinetic Profile of Soticlestat in Healthy Participants",COMPLETED,,PHASE1,28.0,ACTUAL,Takeda,,2.0,,,f,,,,f,t,f,,,f,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,INDUSTRY,,,,,,,2021,1.0
NCT02586610,,2015-10-22,,,2017-01-18,2015-10-23,2015-10-26,ESTIMATED,,,,,,,2017-01-18,2017-01-20,ESTIMATED,2016-10,ACTUAL,2016-10-31,2017-01,2017-01-31,2020-12,ESTIMATED,2020-12-31,2018-06,ESTIMATED,2018-06-30,,INTERVENTIONAL,,,Trial of Chemoradiation and Pembrolizumab in Patients With Rectal Cancer,A Phase II Trial of Neoadjuvant Chemoradiation (CRT) and Pembrolizumab in Patients With Rectal Cancer: Hoosier Cancer Research Network GI15-213,WITHDRAWN,,PHASE2,0.0,ACTUAL,Hoosier Cancer Research Network,,1.0,,Dr. Rahma decided to run the study through a different group,f,,,,t,,,,,,,,,,,,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,OTHER,,,,,,,2020,0.0
NCT03523429,,2018-05-01,,,2022-07-26,2018-05-01,2018-05-14,ACTUAL,,,,,,,2022-07-26,2022-07-27,ACTUAL,2018-06-30,ACTUAL,2018-06-30,2022-07,2022-07-31,2022-03-09,ACTUAL,2022-03-09,2019-12-24,ACTUAL,2019-12-24,,INTERVENTIONAL,,,PETHEMA-BLIN-01/PET069014 (BLIN-01),"A Phase II, Open-label Study to Evaluate the Effect of Blinatumomab Administered During Consolidation to Reduce the Level of Minimal Residual Disease (MRD) Assessed Through Flow Cytometry in Adult Patients up to 55 Years of Age With High-risk Philadelphia Chromosome-negative (Ph-) Acute Lymphoblastic Leukaemia (ALL) With Good Response (MRD < 0.1%) After Induction Therapy",TERMINATED,,PHASE2,11.0,ACTUAL,PETHEMA Foundation,,1.0,,Low rate of recruitment,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,OTHER,,,,,,,2022,0.0
NCT03862846,,2019-02-28,,,2020-07-14,2019-03-01,2019-03-05,ACTUAL,,,,,,,2020-07-14,2020-07-16,ACTUAL,2019-05-10,ACTUAL,2019-05-10,2020-03,2020-03-31,2020-04-23,ACTUAL,2020-04-23,2020-04-23,ACTUAL,2020-04-23,,INTERVENTIONAL,,,A Study of the Safety of REN001 in Patients With Primary Mitochondrial Myopathy,"An Open-label Study to Evaluate the Safety and Tolerability of 12 Weeks Treatment With Oral REN001 in Patients With Primary Mitochondrial Myopathy (PMM), With an Optional Extension of Treatment",TERMINATED,,PHASE1,23.0,ACTUAL,Reneo Pharma Ltd,,1.0,,COVID-19 Pandemic sufficient data gathered to achieve the study objective,f,,,,f,f,f,,,,,,,,,,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,INDUSTRY,,,,,,,2020,0.0
NCT05559125,,2022-09-26,,,2024-05-20,2022-09-26,2022-09-29,ACTUAL,,,,,,,2024-05-20,2024-05-22,ACTUAL,2022-11-08,ACTUAL,2022-11-08,2023-12,2023-12-31,2024-03-26,ACTUAL,2024-03-26,2024-03-26,ACTUAL,2024-03-26,,INTERVENTIONAL,,,A Study of STSA-1002 Combined With STSA-1005 in Healthy Subjects,"An Open-label, Single-ascending Dose Phase I Study to Evaluate the Safety and Tolerability of STSA-1002 Combined With STSA-1005 in Healthy Subjects",TERMINATED,,PHASE1,50.0,ACTUAL,"Staidson (Beijing) Biopharmaceuticals Co., Ltd",,4.0,,"Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.",f,,,,f,f,f,,,,,,,,,,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2024,0.0
NCT03033316,,2017-01-03,,,2020-11-04,2017-01-24,2017-01-26,ESTIMATED,,,,,,,2020-11-04,2020-11-06,ACTUAL,2017-01,ACTUAL,2017-01-31,2020-11,2020-11-30,2020-08,ACTUAL,2020-08-31,2020-08,ACTUAL,2020-08-31,,INTERVENTIONAL,AMETHYST,,A Evaluation of the Safety of Oncocort IV Pegylated Liposomal Dexamethasone Phosphate in Patients With Progressive Multiple Myeloma,"A Phase I-IIa, Open Label, Multi-Center, Dose Escalating Study to Evaluate the Safety of Intravenous Pegylated Liposomal Dexamethasone Sodium Phosphate (Oncocort) as Monotherapy in Patients With Previously Treated Progressive Multiple Myeloma",TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,Enceladus Pharmaceuticals BV,,1.0,,Patient enrolment issues,f,,,,t,,,,,,,,,,,NO,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,INDUSTRY,,,,,,,2020,0.0
NCT02198794,,2014-07-22,2020-11-30,,2022-03-31,2014-07-22,2014-07-24,ESTIMATED,2021-02-09,2021-03-01,ACTUAL,,,,2022-03-31,2022-04-01,ACTUAL,2014-10-20,ACTUAL,2014-10-20,2022-03,2022-03-31,2020-12-14,ACTUAL,2020-12-14,2019-12-06,ACTUAL,2019-12-06,,INTERVENTIONAL,RIM-TD,"ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug.",Reducing Involuntary Movements in Participants With Tardive Dyskinesia,"An Open-Label, Long-Term Safety Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia",COMPLETED,,PHASE3,343.0,ACTUAL,"Teva Branded Pharmaceutical Products R&D, Inc.",,4.0,,,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.)",2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2020,1.0
NCT04125732,,2019-10-04,,,2024-01-29,2019-10-11,2019-10-14,ACTUAL,,,,,,,2024-01-29,2024-01-30,ACTUAL,2020-01-24,ACTUAL,2020-01-24,2024-01,2024-01-31,2023-05-30,ACTUAL,2023-05-30,2023-01-31,ACTUAL,2023-01-31,,INTERVENTIONAL,EXACT,,Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial),"A Phase 1/2 Trial of Direct Administration of AdVEGF-All6A+, a Replication Deficient Adenovirus Vector Expressing a cDNA/Genomic Hybrid of Human VEGF, to the Ischemic Myocardium of Subjects With Angina Pectoris",COMPLETED,,PHASE1/PHASE2,41.0,ACTUAL,"XyloCor Therapeutics, Inc.",,4.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,INDUSTRY,,,,,,,2023,1.0
NCT03689712,,2018-09-27,2023-02-15,,2023-10-19,2018-09-27,2018-09-28,ACTUAL,2023-04-12,2023-04-13,ACTUAL,,,,2023-10-19,2023-10-24,ACTUAL,2018-10-03,ACTUAL,2018-10-03,2023-10,2023-10-31,2023-08-25,ACTUAL,2023-08-25,2021-08-13,ACTUAL,2021-08-13,,INTERVENTIONAL,,"Intent-to-Treat (ITT) population includes all randomized subjects who received at least one dose of GC4419/Placebo, with the exception of the 28 subjects whose treatment course was discontinued during the Sponsor's voluntary suspension of dosing.",ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients,"ROMAN: Reduction in Oral Mucositis With Avasopasem Manganese (GC4419) - Phase 3 Trial in Patients Receiving Chemoradiotherapy for Locally-Advanced, Non-Metastatic Head and Neck Cancer",COMPLETED,,PHASE3,455.0,ACTUAL,"Galera Therapeutics, Inc.",,2.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2023,1.0
NCT04197999,,2019-12-04,,,2022-03-07,2019-12-11,2019-12-13,ACTUAL,,,,,,,2022-03-07,2022-03-22,ACTUAL,2019-11-21,ACTUAL,2019-11-21,2022-03,2022-03-31,2021-08-25,ACTUAL,2021-08-25,2021-08-25,ACTUAL,2021-08-25,,INTERVENTIONAL,,,A Study to Determine Safety and Tolerability of GMI-1359 in Subjects With HR+ Metastatic Breast Cancer,"A Phase 1b, Single and Multiple Dose, Open-Label Trial of Intravenous GMI-1359 in HR+ Metastatic Breast Cancer Subjects",TERMINATED,,PHASE1,4.0,ACTUAL,GlycoMimetics Incorporated,,1.0,,"After demonstrating the on target effect of GMI-1359 via pharmacodynamic markers (CXCR4 and E-selectin), Sponsor terminated the trial due to COVID-related slow enrollment.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,INDUSTRY,,,,,,,2021,0.0
NCT02855944,,2016-07-22,2021-11-29,,2023-06-07,2016-08-01,2016-08-04,ESTIMATED,2022-01-19,2022-02-11,ACTUAL,,,,2023-06-07,2023-06-09,ACTUAL,2017-03-01,ACTUAL,2017-03-01,2023-06,2023-06-30,2022-09-16,ACTUAL,2022-09-16,2020-12-03,ACTUAL,2020-12-03,,INTERVENTIONAL,,,"ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients","ARIEL4 (Assessment of Rucaparib In Ovarian CancEr TriaL): A Phase 3 Multicenter, Randomized Study of Rucaparib Versus Chemotherapy in Patients With Relapsed, BRCA Mutant, High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer",COMPLETED,,PHASE3,349.0,ACTUAL,pharmaand GmbH,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2022,1.0
NCT00695786,,2008-06-10,2021-07-11,,2021-09-28,2008-06-10,2008-06-12,ESTIMATED,2021-09-01,2021-09-29,ACTUAL,,,,2021-09-28,2021-10-20,ACTUAL,2008-06-10,ACTUAL,2008-06-10,2021-09,2021-09-30,2020-07-11,ACTUAL,2020-07-11,2020-07-11,ACTUAL,2020-07-11,,INTERVENTIONAL,,,Lenalidomide in Combination With Rituximab in Treating Participants With Stage III/IV Indolent Non-Hodgkin Lymphoma,A Phase II Study of Revlimid in Combination With Rituximab as Initial Treatment for Patients With Indolent Non-Hodgkin's Lymphoma (NHL),COMPLETED,,PHASE2,156.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,OTHER,,,,,,,2020,1.0
NCT04847557,,2021-02-26,,,2024-07-19,2021-04-13,2021-04-19,ACTUAL,,,,,,,2024-07-19,2024-07-22,ACTUAL,2021-04-20,ACTUAL,2021-04-20,2024-07,2024-07-31,2024-07-02,ACTUAL,2024-07-02,2024-07-02,ACTUAL,2024-07-02,,INTERVENTIONAL,,,A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial,"A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)",COMPLETED,,PHASE3,731.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2024,1.0
NCT03395080,,2018-01-02,2023-01-17,,2023-06-27,2018-01-08,2018-01-10,ACTUAL,2023-05-16,2023-06-09,ACTUAL,,,,2023-06-27,2023-07-12,ACTUAL,2018-03-05,ACTUAL,2018-03-05,2023-05,2023-05-31,2021-01-27,ACTUAL,2021-01-27,2020-09-09,ACTUAL,2020-09-09,,INTERVENTIONAL,P204,,A Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial or Epithelial Ovarian Cancer or Carcinosarcoma,"A Phase 2 Study Evaluating the Efficacy and Safety of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial, Epithelial Ovarian Cancer, or Carcinosarcoma",COMPLETED,,PHASE2,111.0,ACTUAL,"Leap Therapeutics, Inc.",,6.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,INDUSTRY,,,,,,,2021,1.0
NCT02252432,,2014-09-26,2024-01-16,,2024-02-05,2014-09-29,2014-09-30,ESTIMATED,2024-02-05,2024-02-29,ACTUAL,,,,2024-02-05,2024-02-29,ACTUAL,2013-02,ACTUAL,2013-02-28,2024-02,2024-02-29,2023-01,ACTUAL,2023-01-31,2023-01,ACTUAL,2023-01-31,,INTERVENTIONAL,,,The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy,"Intraoperative Ketamine and Methadone for Laminectomy: Effect on Recovery, Postoperative Pain, and Opioid Requirements",TERMINATED,,PHASE4,13.0,ACTUAL,Cedars-Sinai Medical Center,,3.0,,"No enough recruitments, very slow enrollment over the years",f,,,,f,,,,,,,,,,,,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,OTHER,,,,,,,2023,0.0
NCT05463068,,2022-07-14,,2023-03-29,2023-07-18,2022-07-14,2022-07-18,ACTUAL,,,,,2023-04-06,ACTUAL,2023-07-18,2023-07-20,ACTUAL,2022-07-11,ACTUAL,2022-07-11,2023-07,2023-07-31,2022-09-01,ACTUAL,2022-09-01,2022-08-17,ACTUAL,2022-08-17,,INTERVENTIONAL,,,Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults,"A Randomized, Observer-Blinded, Phase 3 Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults",COMPLETED,,PHASE3,911.0,ACTUAL,Novavax,,3.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2022,1.0
NCT02176863,,2014-06-25,,2023-11-23,2023-11-23,2014-06-25,2014-06-27,ESTIMATED,,,,,2023-11-27,ACTUAL,2023-11-23,2023-11-27,ACTUAL,2014-09-23,ACTUAL,2014-09-23,2023-11,2023-11-30,2022-11-24,ACTUAL,2022-11-24,2022-11-24,ACTUAL,2022-11-24,,INTERVENTIONAL,FORCE,,Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in Patients With Post-polio Syndrome,"A Multicenter, Prospective, Randomized, Placebo-controlled, Double-blind, Parallel-group Clinical Trial to Assess the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in Patients With Post-Polio Syndrome",TERMINATED,,PHASE2/PHASE3,191.0,ACTUAL,Grifols Therapeutics LLC,,5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,INDUSTRY,,,,,,,2022,0.0
NCT00085202,,2004-06-10,2013-11-04,,2024-01-11,2004-06-10,2004-06-11,ESTIMATED,2014-01-09,2014-02-27,ESTIMATED,,,,2024-01-11,2024-02-08,ACTUAL,2003-08,,2003-08-31,2024-01,2024-01-31,2023-12-31,ACTUAL,2023-12-31,2016-12,ACTUAL,2016-12-31,,INTERVENTIONAL,,"Participants had a diagnosis of medulloblastoma, supratentorial primitive neuroectodermal tumor (PNET), PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma), or atypical teratoid rhabdoid tumor (ATRT).","Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor","Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor",COMPLETED,,PHASE3,416.0,ACTUAL,St. Jude Children's Research Hospital,The study participants for Secondary Outcome Measure #4 were randomized to standard-of-care group vs. reading intervention after medical treatment. The participants were a subset of patients who contributed to the primary aim and who signed a separate consent form distinct from the main medical treatment consent. They were then randomly assigned to either the standard-of-care group (SOC) or to the reading intervention (RI) group.,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,OTHER,,,,,,,2023,1.0
NCT02833844,,2016-06-13,2020-06-25,,2022-07-15,2016-07-12,2016-07-14,ESTIMATED,2020-07-20,2020-07-21,ACTUAL,,,,2022-07-15,2022-07-22,ACTUAL,2017-05-22,ACTUAL,2017-05-22,2022-07,2022-07-31,2020-01-27,ACTUAL,2020-01-27,2019-07-09,ACTUAL,2019-07-09,,INTERVENTIONAL,,,"Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia","A Double Blind, Randomized, Placebo Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy on LDL-C of Evolocumab (AMG 145) in Subjects With HIV and With Hyperlipidemia and/or Mixed Dyslipidemia",COMPLETED,,PHASE3,467.0,ACTUAL,Amgen,,2.0,,,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,INDUSTRY,,,,,,,2020,1.0
NCT02887248,,2016-08-29,2021-11-16,,2023-12-01,2016-08-29,2016-09-02,ESTIMATED,2021-12-15,2022-01-13,ACTUAL,,,,2023-12-01,2023-12-05,ACTUAL,2017-01-12,ACTUAL,2017-01-12,2021-12,2021-12-31,2020-05-01,ACTUAL,2020-05-01,2020-05-01,ACTUAL,2020-05-01,,INTERVENTIONAL,,,Nab-paclitaxel Plus Gemcitabine as First-line Therapy for Cisplatin-ineligible or Cisplatin-incurable Advanced Urothelial Carcinoma,Phase II Study of Nanoparticle Albumin-bound Paclitaxel Plus Gemcitabine as First-line Therapy for the Treatment of Cisplatin-ineligible or Cisplatin-incurable Advanced Urothelial Carcinoma,TERMINATED,,PHASE2,3.0,ACTUAL,"SCRI Development Innovations, LLC",,1.0,,Enrollment issues,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,OTHER,,,,,,,2020,0.0
NCT04896112,,2021-05-08,,,2023-06-15,2021-05-17,2021-05-21,ACTUAL,,,,,,,2023-06-15,2023-06-18,ACTUAL,2021-04-08,ACTUAL,2021-04-08,2023-06,2023-06-30,2022-10-20,ACTUAL,2022-10-20,2022-10-20,ACTUAL,2022-10-20,,INTERVENTIONAL,,,"A Study of LNK01002 in Patients With Primary or Secondary Myelofibrosis,Polycythemia Vera or Acute Myeloid Leukemia","An Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of LNK01002 in Patients With Malignant Myeloid Hematologic Neoplasms",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Lynk Pharmaceuticals Co., Ltd",,10.0,,sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,INDUSTRY,,,,,,,2022,0.0
NCT03444753,,2018-02-20,,,2022-05-17,2018-02-20,2018-02-23,ACTUAL,,,,,,,2022-05-17,2022-05-23,ACTUAL,2018-04-05,ACTUAL,2018-04-05,2022-05,2022-05-31,2022-02-14,ACTUAL,2022-02-14,2022-02-14,ACTUAL,2022-02-14,,INTERVENTIONAL,,,An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed,A Phase I Study of BMS-986299 as Monotherapy and in Combination With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers,TERMINATED,,PHASE1,82.0,ACTUAL,Bristol-Myers Squibb,,2.0,,business objectives have changed,f,,,,f,t,f,,,,,,,,,,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,INDUSTRY,,,,,,,2022,0.0
NCT02771626,,2016-05-06,2023-01-23,2021-01-29,2023-02-21,2016-05-12,2016-05-13,ESTIMATED,2023-02-21,2023-03-17,ACTUAL,2021-01-29,2021-02-02,ACTUAL,2023-02-21,2023-03-17,ACTUAL,2016-08-01,ACTUAL,2016-08-01,2023-02,2023-02-28,2020-04-24,ACTUAL,2020-04-24,2020-04-24,ACTUAL,2020-04-24,,INTERVENTIONAL,,,"Study CB-839 in Combination With Nivolumab in Patients With Melanoma, Clear Cell Renal Cell Carcinoma (ccRCC) and Non-Small Cell Lung Cancer (NSCLC)","A Phase 1/2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Glutaminase Inhibitor CB-839 in Combination With Nivolumab in Patients With Advanced/Metastatic Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer",TERMINATED,,PHASE1/PHASE2,118.0,ACTUAL,"Calithera Biosciences, Inc",,6.0,,lack of efficacy,f,,,,f,,,,,,,,,,,NO,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2020,0.0
NCT04333628,,2020-04-01,,,2020-10-13,2020-04-02,2020-04-03,ACTUAL,,,,,,,2020-10-13,2020-10-14,ACTUAL,2020-06-01,ACTUAL,2020-06-01,2020-10,2020-10-31,2020-09-01,ACTUAL,2020-09-01,2020-09-01,ACTUAL,2020-09-01,,INTERVENTIONAL,,,Chloroquine for Mild Symptomatic and Asymptomatic COVID-19,"Chloroquine for Mild Symptomatic and Asymptomatic COVID-19 in A Two Staged, Multicenter, Open Label and Randomized Trial",TERMINATED,,PHASE2/PHASE3,5.0,ACTUAL,"HaEmek Medical Center, Israel",,3.0,,Teminated due to changes in treatment guidelines .,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,OTHER,,,,,,,2020,0.0
NCT04526509,,2020-08-21,2023-12-01,,2023-12-01,2020-08-21,2020-08-25,ACTUAL,2023-12-01,2024-05-10,ACTUAL,,,,2023-12-01,2024-05-10,ACTUAL,2020-12-21,ACTUAL,2020-12-21,2023-11,2023-11-30,2023-06-08,ACTUAL,2023-06-08,2023-06-08,ACTUAL,2023-06-08,,INTERVENTIONAL,,Intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.,Master Protocol to Assess Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors,"Master Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T-cells, Alone or in Combination With Other Agents, in Participants With Advanced Tumors",TERMINATED,,PHASE1,12.0,ACTUAL,GlaxoSmithKline,,4.0,,The study was terminated due to a change in GSK's R\&D priorities.,f,,,,f,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,INDUSTRY,,,,,,,2023,0.0
NCT04835168,,2021-03-10,,,2023-06-06,2021-04-05,2021-04-08,ACTUAL,,,,,,,2023-06-06,2023-06-07,ACTUAL,2022-01-30,ESTIMATED,2022-01-30,2023-06,2023-06-30,2022-06-30,ESTIMATED,2022-06-30,2022-04-30,ESTIMATED,2022-04-30,,INTERVENTIONAL,,,Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis,"A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis",WITHDRAWN,,PHASE1,0.0,ACTUAL,NImmune Biopharma,,3.0,,The closure of the study is driven by the decision to redesign the study protocol for future studies.,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2022,0.0
NCT04586920,,2020-10-13,,,2022-12-19,2020-10-13,2020-10-14,ACTUAL,,,,,,,2022-12-19,2022-12-21,ACTUAL,2020-10-20,ACTUAL,2020-10-20,2022-12,2022-12-31,2022-10-14,ACTUAL,2022-10-14,2022-10-14,ACTUAL,2022-10-14,,INTERVENTIONAL,,,A Study of LY3509754 in Healthy Non-Japanese and Japanese Participants,"A Phase 1, Randomized, Participant-and Investigator-Blind, Placebo-Controlled, Single-and Multiple-Ascending Dose, Drug-Drug Interaction and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3509754 in Healthy Non-Japanese and Japanese Participants",TERMINATED,,PHASE1,104.0,ACTUAL,Eli Lilly and Company,,8.0,,Terminated due to safety findings,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,INDUSTRY,,,,,,,2022,0.0
NCT02278120,,2014-10-22,2018-08-17,2018-07-16,2024-02-13,2014-10-28,2014-10-29,ESTIMATED,2019-02-04,2019-02-26,ACTUAL,2018-07-16,2018-07-18,ACTUAL,2024-02-13,2024-03-12,ACTUAL,2014-11-20,ACTUAL,2014-11-20,2024-02,2024-02-29,2023-04-20,ACTUAL,2023-04-20,2017-08-21,ACTUAL,2017-08-21,,INTERVENTIONAL,MONALEESA-7,,"Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer","A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer",COMPLETED,,PHASE3,672.0,ACTUAL,Novartis,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,INDUSTRY,,,,,,,2023,1.0
NCT03517995,,2018-04-26,,,2020-05-26,2018-04-26,2018-05-08,ACTUAL,,,,,,,2020-05-26,2020-05-28,ACTUAL,2020-04,ESTIMATED,2020-04-30,2020-02,2020-02-29,2022-12,ESTIMATED,2022-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,"Randomized, Phase II Clinical Trial of Sulforaphane in Bladder Cancer Chemoprevention","Randomized, Phase II Clinical Trial of Sulforaphane in Bladder Cancer Chemoprevention",WITHDRAWN,,PHASE2,0.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,2.0,,Grant not approved,,,,,f,t,f,,,,,,,,,,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,OTHER,,,,,,,2022,0.0
NCT03884517,,2019-03-15,,,2023-04-27,2019-03-20,2019-03-21,ACTUAL,,,,,,,2023-04-27,2023-05-01,ACTUAL,2019-03-15,ACTUAL,2019-03-15,2023-04,2023-04-30,2021-02-08,ACTUAL,2021-02-08,2021-02-08,ACTUAL,2021-02-08,,INTERVENTIONAL,,,Clinical Trial of BAT8003 (for Injection) for Patients With Advanced Epithelial Cancer,"An Open, Escalating Phase I Clinical Trial of BAT8003 (for Injection) on the Safety, Tolerability and Pharmacokinetics for Patients With Advanced Epithelial Cancer",TERMINATED,,PHASE1,5.0,ACTUAL,Bio-Thera Solutions,,9.0,,"Considering that the safety risk will affect the subsequent development, it is decided to terminate the test voluntarily",f,,,,f,f,f,,,,,,,,,,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,INDUSTRY,,,,,,,2021,0.0
NCT02054520,,2014-02-03,2020-01-31,2019-04-17,2023-03-27,2014-02-03,2014-02-04,ESTIMATED,2020-04-20,2020-04-29,ACTUAL,2019-05-17,2019-05-24,ACTUAL,2023-03-27,2023-04-18,ACTUAL,2014-06,,2014-06-30,2023-03,2023-03-31,2021-01-05,ACTUAL,2021-01-05,2018-04-05,ACTUAL,2018-04-05,,INTERVENTIONAL,,,Immunotherapy Study for Patients With Stage IV Melanoma,A Phase 2b Study of Immune Checkpoint Inhibition With or Without Dorgenmeltucel-L (HyperAcute Melanoma) Immunotherapy for Stage IV Melanoma Patients,TERMINATED,,PHASE2,47.0,ACTUAL,Lumos Pharma,Early termination leading to small numbers of subjects analyzed. The enrollment and treatment phase of this trial was terminated early and the IND has been closed.,6.0,,Withdrawal of IND,f,,,,,,,,,,,,,,,,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,INDUSTRY,,,,,,,2021,0.0
NCT03037931,,2017-01-25,2024-02-02,,2024-06-07,2017-01-27,2017-01-31,ESTIMATED,2024-06-07,2024-07-03,ACTUAL,,,,2024-06-07,2024-07-03,ACTUAL,2017-03-15,ACTUAL,2017-03-15,2024-02,2024-02-29,2023-02-02,ACTUAL,2023-02-02,2023-02-02,ACTUAL,2023-02-02,,INTERVENTIONAL,HEART-FID,,Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study,"A Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure With Iron Deficiency /and Sub-Study",COMPLETED,,PHASE3,3065.0,ACTUAL,"American Regent, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,INDUSTRY,,,,,,,2023,0.0
NCT04707703,,2021-01-08,,,2022-11-23,2021-01-11,2021-01-13,ACTUAL,,,,,,,2022-11-23,2022-11-25,ACTUAL,2021-03-16,ACTUAL,2021-03-16,2022-07,2022-07-31,2021-10-25,ACTUAL,2021-10-25,2021-10-25,ACTUAL,2021-10-25,,INTERVENTIONAL,Isavu-CAPA,,Isavuconazole for the Prevention of COVID-19-associated Pulmonary Aspergillosis,Isavuconazole for the Prevention of SARS-CoV-2-associated Invasive Aspergillosis in Critically-Ill Patients,TERMINATED,,PHASE3,8.0,ACTUAL,"University of California, San Diego",,2.0,,Participant enrollment challenges,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,OTHER,,,,,,,2021,0.0
NCT04950504,,2021-06-03,,,2023-09-14,2021-06-23,2021-07-06,ACTUAL,,,,,,,2023-09-14,2023-09-18,ACTUAL,2021-06-02,ACTUAL,2021-06-02,2023-09,2023-09-30,2022-07-29,ACTUAL,2022-07-29,2022-06-24,ACTUAL,2022-06-24,,INTERVENTIONAL,,,"Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-201 in Subjects Ages 16-35 With Peanut Allergy","A Two-Part 1b/2a Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-201 in Subjects Ages 16-35 With Peanut Allergy",TERMINATED,,PHASE1,9.0,ACTUAL,"COUR Pharmaceutical Development Company, Inc.",,4.0,,Lagging Enrollment. Opened a separate study.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,INDUSTRY,,,,,,,2022,0.0
NCT01783041,,2013-01-25,2022-01-14,,2023-02-13,2013-01-31,2013-02-04,ESTIMATED,2022-03-07,2022-03-08,ACTUAL,,,,2023-02-13,2023-03-08,ACTUAL,2013-01,,2013-01-31,2023-02,2023-02-28,2021-12-28,ACTUAL,2021-12-28,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants,"A Double-Blind, Controlled, Randomized Clinical Trial of the Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants",COMPLETED,,PHASE2/PHASE3,144.0,ACTUAL,Montefiore Medical Center,This is a single center study.,2.0,,,f,,,,t,t,,,,t,,,,,,,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,OTHER,,,,,,,2021,1.0
NCT04326764,,2019-03-21,,,2023-02-14,2020-03-26,2020-03-30,ACTUAL,,,,,,,2023-02-14,2023-02-16,ACTUAL,2018-07-24,ACTUAL,2018-07-24,2023-02,2023-02-28,2023-02-13,ACTUAL,2023-02-13,2023-02-13,ACTUAL,2023-02-13,,INTERVENTIONAL,,,Panobinostat Maintenance After HSCT fo High-risk AML and MDS,"A Randomized, Multicenter Phase III Study to Assess the Efficacy of Panobinostat Maintenance Therapy vs. Standard of Care Following Allogeneic Stem Cell Transplantation in Patients With High-risk AML or MDS (ETAL-4 / HOVON-145)",TERMINATED,,PHASE3,52.0,ACTUAL,Goethe University,,2.0,,Change of marketing authorisation holder,f,,,,t,f,f,,,,,,,,,,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,OTHER,,,,,,,2023,0.0
NCT01412333,,2011-08-08,2017-03-30,2016-10-21,2024-03-07,2011-08-08,2011-08-09,ESTIMATED,2017-07-17,2017-07-18,ACTUAL,2016-10-25,2016-10-26,ESTIMATED,2024-03-07,2024-03-08,ACTUAL,2011-09-20,ACTUAL,2011-09-20,2024-03,2024-03-31,2022-12-30,ACTUAL,2022-12-30,2015-05-12,ACTUAL,2015-05-12,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all randomized participants in the study.,A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis,"A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis",COMPLETED,,PHASE3,835.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,INDUSTRY,,,,,,,2022,1.0
NCT04730427,,2021-01-20,,,2022-11-25,2021-01-27,2021-01-29,ACTUAL,,,,,,,2022-11-25,2022-11-30,ACTUAL,2021-03-24,ACTUAL,2021-03-24,2022-03,2022-03-31,2022-07-07,ACTUAL,2022-07-07,2022-05-08,ACTUAL,2022-05-08,,INTERVENTIONAL,,,Safety and Preliminary Efficacy Study of GX-I7 in Patients With COVID-19,A Phase 1b Study to Investigate the Safety and Preliminary Efficacy of GX-I7 in Patients With COVID-19,TERMINATED,,PHASE1,10.0,ACTUAL,"Genexine, Inc.",,2.0,,Sponsor's decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2022,0.0
NCT04061590,,2019-08-16,,,2022-02-17,2019-08-16,2019-08-20,ACTUAL,,,,,,,2022-02-17,2022-03-04,ACTUAL,2020-05-29,ACTUAL,2020-05-29,2022-02,2022-02-28,2023-08-31,ESTIMATED,2023-08-31,2023-08-31,ESTIMATED,2023-08-31,,INTERVENTIONAL,,,Pembrolizumab With or Without Chemotherapy Before Surgery in Treating Patients With Stage I-IIIA Non-Small Cell Lung Cancer,A Phase 2 Study of Neoadjuvant Pembrolizumab-Based Combination Immunotherapy in the Treatment of Early Stage Non-Small Cell Lung Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, San Francisco",,2.0,,Low Accrual,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,OTHER,,,,,,,2023,0.0
NCT04832139,,2021-03-26,,,2022-07-07,2021-04-02,2021-04-05,ACTUAL,,,,,,,2022-07-07,2022-07-11,ACTUAL,2021-03-30,ACTUAL,2021-03-30,2022-07,2022-07-31,2021-11-22,ACTUAL,2021-11-22,2021-11-22,ACTUAL,2021-11-22,,INTERVENTIONAL,,,A Study of Marstacimab to Compare Prefilled Pen (PFP) Device to Prefilled Syringe (PFS) Device,"A PHASE 1, OPEN-LABEL, RANDOMIZED, 4-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF MARSTACIMAB (PF-06741086) PREFILLED SYRINGE DEVICE AND PREFILLED PEN DEVICE FOLLOWING SUBCUTANEOUS ADMINISTRATION IN HEALTHY ADULT MALE PARTICIPANTS",TERMINATED,,PHASE1,22.0,ACTUAL,Pfizer,,2.0,,The study was terminated due to a change in the benefit/risk assessment for the further administration of marstacimab in a healthy volunteer population.,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2021,0.0
NCT04262817,,2020-02-04,2023-01-10,,2023-05-01,2020-02-06,2020-02-10,ACTUAL,2023-05-01,2023-05-26,ACTUAL,,,,2023-05-01,2023-05-26,ACTUAL,2020-11-01,ACTUAL,2020-11-01,2023-05,2023-05-31,2022-02-02,ACTUAL,2022-02-02,2022-01-10,ACTUAL,2022-01-10,,INTERVENTIONAL,,"Of the 20 participants enrolled, only 16 were randomized and participated in the study.",The Interaction of Flavor With Nicotine Form in Adult Smokers,The Interaction of Flavor With Nicotine Form in Adult Smokers,COMPLETED,,PHASE1,20.0,ACTUAL,Yale University,,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,OTHER,,,,,,,2022,1.0
NCT04873895,,2021-04-30,,,2024-04-25,2021-04-30,2021-05-05,ACTUAL,,,,,,,2024-04-25,2024-04-26,ACTUAL,2022-01-24,ACTUAL,2022-01-24,2024-04,2024-04-30,2024-04-25,ACTUAL,2024-04-25,2024-04-25,ACTUAL,2024-04-25,,INTERVENTIONAL,TACE-Ax-HCQ,,TACE Plus Axitinib and Hydroxychlorquine for Liver-Dominant Metastatic Colorectal Cancer (CRC),Phase 1B Study of Hepatic Chemoembolization Plus Axitinib and Hydroxychlorquine for Liver-Dominant Metastatic Adenocarcinoma Of The Colon And Rectum,TERMINATED,,PHASE1,5.0,ACTUAL,Abramson Cancer Center at Penn Medicine,,1.0,,failure to accrue,f,,,,f,t,t,,,f,,,,,,NO,,2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,OTHER,,,,,,,2024,0.0
NCT04218071,,2020-01-02,,,2024-02-05,2020-01-03,2020-01-06,ACTUAL,,,,,,,2024-02-05,2024-02-07,ACTUAL,2020-08-20,ACTUAL,2020-08-20,2024-02,2024-02-29,2024-01-18,ACTUAL,2024-01-18,2022-10-13,ACTUAL,2022-10-13,,INTERVENTIONAL,,,Actuate 1901: 9-ING-41 in Myelofibrosis,"Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase 3 Beta (GSK 3β) Inhibitor, as a Single Agent or Combined With Ruxolitinib, in Patients With Myelofibrosis",COMPLETED,,PHASE2,17.0,ACTUAL,Actuate Therapeutics Inc.,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2024,1.0
NCT04657003,,2020-12-01,2024-03-08,,2024-03-08,2020-12-01,2020-12-07,ACTUAL,2024-03-08,2024-04-08,ACTUAL,,,,2024-03-08,2024-04-08,ACTUAL,2021-03-29,ACTUAL,2021-03-29,2024-03,2024-03-31,2023-04-10,ACTUAL,2023-04-10,2023-03-16,ACTUAL,2023-03-16,,INTERVENTIONAL,SURMOUNT-2,All randomized participants.,A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight,"Efficacy and Safety of Tirzepatide Once Weekly in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-2)",COMPLETED,,PHASE3,938.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,f,t,f,,,,,,"Time Frame:~Data are available 6 months after the primary publication or approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://www.vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,INDUSTRY,,,,,,,2023,1.0
NCT02973711,,2016-11-22,,,2021-02-11,2016-11-22,2016-11-25,ESTIMATED,,,,,,,2021-02-11,2021-02-16,ACTUAL,2018-01,ESTIMATED,2018-01-31,2021-02,2021-02-28,2021-08,ESTIMATED,2021-08-31,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,,,A Study of Ruxolitinib in Combination With Nilotinib in Patients With Chronic Phase CML,"A Phase I/II Study of Ruxolitinib in Combination With Nilotinib in Patients With Chronic Phase CML Who Have Achieved a Complete Hematologic Remission, Complete Cytogenetic Remission, and Major Molecular Remission, But Not a Complete Molecular Remission on a Tyrosine Kinase Inhibitor Alone.",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Michigan Rogel Cancer Center,,1.0,,lack of funding,f,,,,t,t,f,,,,,,,,,,,2024-10-16 01:08:56.059499,2024-10-16 01:08:56.059499,OTHER,,,,,,,2021,0.0
NCT03287414,,2017-09-12,2023-02-13,2021-10-26,2024-06-14,2017-09-14,2017-09-19,ACTUAL,2023-02-13,2023-03-10,ACTUAL,2021-10-26,2021-10-28,ACTUAL,2024-06-14,2024-06-18,ACTUAL,2017-12-20,ACTUAL,2017-12-20,2024-06,2024-06-30,2022-02-14,ACTUAL,2022-02-14,2020-11-25,ACTUAL,2020-11-25,,INTERVENTIONAL,,Baseline characteristics are provided for all participants who received at least one dose of any study drug,"Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis","A Subject-, Investigator-, and Sponsor-blinded, Randomized, Placebo-controlled, Multicenter Study to Investigate Efficacy, Safety, and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis",TERMINATED,,PHASE2,30.0,ACTUAL,Novartis,,2.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,INDUSTRY,,,,,,,2022,0.0
NCT02696564,,2016-02-25,2022-03-24,,2022-05-04,2016-02-25,2016-03-02,ESTIMATED,2022-05-04,2022-06-01,ACTUAL,,,,2022-05-04,2022-06-01,ACTUAL,2017-05-23,ACTUAL,2017-05-23,2022-05,2022-05-31,2021-06-30,ACTUAL,2021-06-30,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,LEEP,,Losartan Effects on Emphysema Progression,Losartan Effects on Emphysema Progression,COMPLETED,,PHASE4,220.0,ACTUAL,JHSPH Center for Clinical Trials,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC),2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,OTHER,,,,,,,2021,1.0
NCT02978443,,2016-11-23,2023-12-15,,2024-03-07,2016-11-28,2016-12-01,ESTIMATED,2024-03-07,2024-04-04,ACTUAL,,,,2024-03-07,2024-04-04,ACTUAL,2017-07-26,ACTUAL,2017-07-26,2024-03,2024-03-31,2022-08-02,ACTUAL,2022-08-02,2020-07-28,ACTUAL,2020-07-28,,INTERVENTIONAL,,,A Biomarker Study in Advanced Mucosal or Acral Lentiginous Melanoma Receiving Nivolumab in Combination With Ipilimumab,A Study to Estimate the Anti-Tumor Activity and Identify Potential Predictors of Response in Patients With Advanced Mucosal or Acral Lentiginous Melanoma Receiving Standard Nivolumab in Combination With Ipilimumab Followed by Nivolumab Monotherapy,TERMINATED,,PHASE2,14.0,ACTUAL,Georgetown University,,1.0,,Lack of Enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,OTHER,,,,,,,2022,0.0
NCT04880642,,2021-04-28,2023-08-23,,2023-12-11,2021-05-10,2021-05-11,ACTUAL,2023-12-11,2023-12-14,ACTUAL,,,,2023-12-11,2023-12-14,ACTUAL,2021-09-16,ACTUAL,2021-09-16,2023-12,2023-12-31,2022-04-25,ACTUAL,2022-04-25,2022-04-25,ACTUAL,2022-04-25,,INTERVENTIONAL,ATTRACT-3,,A Trial to Investigate Recovery From COVID-19 With C21 in Adult Subjects,"A Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 3, Multicenter Trial Investigating the Efficacy and Safety of C21 as add-on to Standard of Care in Adult Subjects With COVID-19",COMPLETED,,PHASE3,272.0,ACTUAL,Vicore Pharma AB,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,INDUSTRY,,,,,,,2022,1.0
NCT02907918,,2016-09-14,2021-08-10,,2021-09-08,2016-09-14,2016-09-20,ESTIMATED,2021-08-10,2021-09-05,ACTUAL,,,,2021-09-08,2021-09-29,ACTUAL,2017-06-30,ACTUAL,2017-06-30,2021-09,2021-09-30,2020-09-23,ACTUAL,2020-09-23,2020-08-24,ACTUAL,2020-08-24,,INTERVENTIONAL,PALTAN,,Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer,A Phase II Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab as Neoadjuvant Treatment of Stage II-III ER+ HER2+ Breast Cancer (PALTAN),TERMINATED,,PHASE2,26.0,ACTUAL,Washington University School of Medicine,,1.0,,Futility,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,OTHER,,,,,,,2020,0.0
NCT02764801,,2016-04-21,2023-06-28,,2023-11-28,2016-05-03,2016-05-06,ESTIMATED,2023-08-29,2023-09-21,ACTUAL,,,,2023-11-28,2023-12-19,ACTUAL,2016-04,,2016-04-30,2023-11,2023-11-30,2023-02-01,ACTUAL,2023-02-01,2021-12,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Contrast-enhanced Ultrasound Evaluation of Chemoembolization,2D and 4D Contrast-enhanced Ultrasound Evaluation of Hepatocellular Carcinoma Chemoembolization,COMPLETED,,PHASE3,131.0,ACTUAL,Thomas Jefferson University,,1.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,OTHER,,,,,,,2023,1.0
NCT04826016,,2021-03-25,,,2023-03-16,2021-03-30,2021-04-01,ACTUAL,,,,,,,2023-03-16,2023-03-20,ACTUAL,2022-03-16,ACTUAL,2022-03-16,2023-03,2023-03-31,2022-03-16,ACTUAL,2022-03-16,2022-03-16,ACTUAL,2022-03-16,,INTERVENTIONAL,POLTER,,POL6326 (Balixafortide) Plus Nab-paclitaxel or Eribulin in Patients With HER2-negative Advanced Breast Cancer,A Phase Ib/II Study to Optimize POL6326 (Balixafortide) in Combination With Nab-paclitaxel or Eribulin in Patients With HER2-negative Advanced Breast Cancer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,MedSIR,,4.0,,Funder decision,f,,,,,f,f,,,,,,,,,,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,OTHER,,,,,,,2022,0.0
NCT04534114,,2020-08-20,2023-05-06,2023-01-12,2023-06-14,2020-08-30,2020-09-01,ACTUAL,2023-06-14,2023-07-03,ACTUAL,,2023-07-03,ACTUAL,2023-06-14,2023-07-03,ACTUAL,2020-09-04,ACTUAL,2020-09-04,2023-06,2023-06-30,2022-05-12,ACTUAL,2022-05-12,2022-01-24,ACTUAL,2022-01-24,,INTERVENTIONAL,RE-THINc ESRD,,"Factor XI LICA to Reduce Events Such as Heart Attack and Stroke in Patients Whose Kidneys Are no Longer Able to Work as They Should and Require Treatment to Filter Wastes From the Blood: Focus is on the Safety of BAY2976217 and the Way the Body Absorbs, Distributes and Removes the Study Drug","Factor XI LICA to Reduce Thrombotic Events in End-Stage Renal Disease Patients on Hemodialysis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of BAY 2976217",COMPLETED,,PHASE2,307.0,ACTUAL,Bayer,,4.0,,,f,,,,t,t,f,,,,,,,,,NO,There are no current plans to share data. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,INDUSTRY,,,,,,,2022,1.0
NCT05093387,,2021-09-29,,,2022-11-10,2021-10-13,2021-10-26,ACTUAL,,,,,,,2022-11-10,2022-11-15,ACTUAL,2022-11-10,ACTUAL,2022-11-10,2022-11,2022-11-30,2022-11-10,ACTUAL,2022-11-10,2022-11-10,ACTUAL,2022-11-10,,INTERVENTIONAL,,,"SGT-53, Carboplatin, and Pembrolizumab for the Treatment of Metastatic Triple Negative Inflammatory Breast Cancer",A Pilot Study of SGT-53 With Carboplatin and Pembrolizumab in Metastatic Triple Negative Inflammatory Breast Cancer,WITHDRAWN,,PHASE1,0.0,ACTUAL,Northwestern University,,1.0,,funding issues and pharmacy preparation for the drug,,,,,t,t,f,,,f,,,,,,,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,OTHER,,,,,,,2022,0.0
NCT04190628,,2019-12-03,,,2024-05-17,2019-12-04,2019-12-09,ACTUAL,,,,,,,2024-05-17,2024-05-21,ACTUAL,2020-06-16,ACTUAL,2020-06-16,2024-05,2024-05-31,2024-04-05,ACTUAL,2024-04-05,2024-04-05,ACTUAL,2024-04-05,,INTERVENTIONAL,,,Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors,"A Phase I, First-In-Human, Multicenter, Open-Label Dose Escalation and Dose Expansion Study of ABM-1310, as a Monotherapy and a Combination Therapy, Administered Orally in Adult Patients With Advanced Solid Tumors Harboring BRAF Mutations",TERMINATED,,PHASE1,53.0,ACTUAL,ABM Therapeutics Corporation,,6.0,,Not related to safety concerns or lack of efficacy,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 14:42:51.330629,2024-10-15 14:42:51.330629,INDUSTRY,,,,,,,2024,0.0
NCT03843541,,2019-02-13,2022-01-20,,2022-04-08,2019-02-13,2019-02-18,ACTUAL,2022-04-08,2023-01-05,ACTUAL,,,,2022-04-08,2023-01-05,ACTUAL,2019-06-25,ACTUAL,2019-06-25,2022-04,2022-04-30,2021-02-05,ACTUAL,2021-02-05,2021-01-23,ACTUAL,2021-01-23,,INTERVENTIONAL,,mITT population - The Modified ITT (mITT) Population comprised all participants in the ITT population who received at least 1 dose or partial dose of the Investigational Medicinal Product (IMP).,"A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions","A Phase III, Multi-centre, Randomized, Rater- and Patient-blind, Placebo- and Active-controlled, Parallel Group Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily (Active Test Treatment), Ambroxol Hydrochloride 30 mg Twice Daily (Active Control Treatment) and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions",COMPLETED,,PHASE3,333.0,ACTUAL,Zambon SpA,,3.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,INDUSTRY,,,,,,,2021,1.0
NCT02301156,,2014-11-20,2022-04-25,2021-03-23,2022-04-25,2014-11-24,2014-11-25,ESTIMATED,2022-04-25,2022-05-20,ACTUAL,2021-03-23,2021-03-26,ACTUAL,2022-04-25,2022-05-20,ACTUAL,2015-01-27,ACTUAL,2015-01-27,2022-04,2022-04-30,2020-04-01,ACTUAL,2020-04-01,2020-04-01,ACTUAL,2020-04-01,,INTERVENTIONAL,GENUINE,ITT Population included all randomized participants.,Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL),"A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination With Ibrutinib Compared to Ibrutinib Alone, in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)",COMPLETED,,PHASE3,126.0,ACTUAL,"TG Therapeutics, Inc.",,2.0,,,f,,,,t,t,,,,,,,,,,NO,TG Therapeutics does not currently plan to share IPD.,2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,INDUSTRY,,,,,,,2020,1.0
NCT04835714,,2021-04-06,,,2023-01-31,2021-04-06,2021-04-08,ACTUAL,,,,,,,2023-01-31,2023-02-01,ACTUAL,2021-04-20,ACTUAL,2021-04-20,2023-01,2023-01-31,2022-01-18,ACTUAL,2022-01-18,2022-01-18,ACTUAL,2022-01-18,,INTERVENTIONAL,,,A Study to Find a Safe and Effective Dose of BI 1701963 Alone and in Combination With BI 3011441 in Patients With Advanced Cancer and a Certain Mutation (Kirsten Rat Sarcoma Viral Oncogene Homologue [KRAS]),A Phase I Open-label Dose Escalation Trial of BI 1701963 as Monotherapy and in Combination With BI 3011441 in Patients With KRAS Mutated Advanced or Metastatic Solid Tumours,TERMINATED,,PHASE1,8.0,ACTUAL,Boehringer Ingelheim,,4.0,,Sponsor decision,f,,,,f,f,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,INDUSTRY,,,,,,,2022,0.0
NCT05724628,,2022-12-18,,,2024-03-22,2023-02-09,2023-02-13,ACTUAL,,,,,,,2024-03-22,2024-03-26,ACTUAL,2023-10,ESTIMATED,2023-10-31,2024-03,2024-03-31,2023-11,ESTIMATED,2023-11-30,2023-11,ESTIMATED,2023-11-30,,INTERVENTIONAL,,,Non-operative vs. Operative Management of Acute Appendicitis in Vulnerable Patient Populations,A Pilot Randomized Trial of Non-operative Versus Operative Management of Acute Appendicitis in Vulnerable Patient Populations,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,Project did not receive final IRB approvals. PI decided to withdrawn research study.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,OTHER,,,,,,,2023,0.0
NCT03483961,,2018-03-16,2021-09-14,,2023-06-29,2018-03-23,2018-03-30,ACTUAL,2021-10-12,2021-11-09,ACTUAL,,,,2023-06-29,2023-07-03,ACTUAL,2018-04-18,ACTUAL,2018-04-18,2023-06,2023-06-30,2020-09-21,ACTUAL,2020-09-21,2020-09-14,ACTUAL,2020-09-14,,INTERVENTIONAL,,Randomized participants.,"Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults","A Phase 2 Parallel-Group, Randomized, Double-Blind Study to Assess the Safety and Immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV-VLP], Unadjuvanted or Alum-adjuvanted)",COMPLETED,,PHASE2,445.0,ACTUAL,Bavarian Nordic,,10.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,INDUSTRY,,,,,,,2020,1.0
NCT03369184,,2017-11-28,,,2020-09-30,2017-12-08,2017-12-11,ACTUAL,,,,,,,2020-09-30,2020-10-05,ACTUAL,2018-01-01,ACTUAL,2018-01-01,2020-09,2020-09-30,2020-08-01,ACTUAL,2020-08-01,2019-05-01,ACTUAL,2019-05-01,,INTERVENTIONAL,EPOXY-IMR,,Elective Percutaneous Coronary Intervention With or Without Supplemental OXYgen,Elective Percutaneous Coronary Intervention With or Without Supplemental OXYgen and Evaluation of Effects on Coronary Microcirculation Using the Index of Microcirculatory Resistance,TERMINATED,,PHASE3,65.0,ACTUAL,Karolinska Institutet,,2.0,,Slow recruitment,f,,,,f,f,f,,,f,,,,,,,,2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,OTHER,,,,,,,2020,0.0
NCT04589832,,2020-10-09,2023-09-19,,2023-11-01,2020-10-09,2020-10-19,ACTUAL,2023-11-01,2023-11-22,ACTUAL,,,,2023-11-01,2023-11-22,ACTUAL,2021-01-11,ACTUAL,2021-01-11,2023-11,2023-11-30,2022-06-24,ACTUAL,2022-06-24,2022-03-22,ACTUAL,2022-03-22,,INTERVENTIONAL,,,Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma,Phase 1B/2 Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma,TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,Hoosier Cancer Research Network,,1.0,,This study required dose reductions to the lower dose level (Dose level -1). But this dose level (Dose level -1) was not further explored because of lack of funding.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,OTHER,,,,,,,2022,0.0
NCT05135546,,2021-11-24,,,2023-06-29,2021-11-24,2021-11-26,ACTUAL,,,,,,,2023-06-29,2023-07-03,ACTUAL,2021-12-27,ACTUAL,2021-12-27,2023-06,2023-06-30,2023-05-31,ACTUAL,2023-05-31,2023-02-01,ACTUAL,2023-02-01,,INTERVENTIONAL,FORRIF,,Inhaled Recombinant Non-immunogenic Staphylokinase vs Placebo in Patients With COVID-19 - FORRIF Trial,Inhaled Recombinant Non-immunogenic Staphylokinase vs Placebo in Patients With COVID-19 - FORRIF Trial,TERMINATED,,PHASE2/PHASE3,4.0,ACTUAL,"Supergene, LLC",,2.0,,No patients,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,INDUSTRY,,,,,,,2023,0.0
NCT03400176,,2018-01-09,,,2024-09-02,2018-01-09,2018-01-17,ACTUAL,,,,,,,2024-09-02,2024-09-19,ACTUAL,2018-04-09,ACTUAL,2018-04-09,2024-09,2024-09-30,2023-09-29,ACTUAL,2023-09-29,2023-09-29,ACTUAL,2023-09-29,,INTERVENTIONAL,,,VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib,Phase Ib Open-label Study of VAY736 and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) on Ibrutinib Therapy,TERMINATED,,PHASE1,39.0,ACTUAL,Novartis,,2.0,,Business reasons,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,INDUSTRY,,,,,,,2023,0.0
NCT03422523,,2018-01-11,,,2022-08-19,2018-02-02,2018-02-05,ACTUAL,,,,,,,2022-08-19,2022-08-22,ACTUAL,2018-05-09,ACTUAL,2018-05-09,2022-08,2022-08-31,2021-11-18,ACTUAL,2021-11-18,2021-01-31,ACTUAL,2021-01-31,,INTERVENTIONAL,ARGO,,"Atezolizumab, Rituximab, Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory DLBCL Not Suitable for High-dose Therapy","A Phase II Study of Atezolizumab With Rituximab, Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Who Are Not Candidates for High-dose Therapy",TERMINATED,,PHASE2,53.0,ACTUAL,University Hospital Southampton NHS Foundation Trust,,2.0,,Failure to reach pre-specified futility boundary,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,OTHER,,,,,,,2021,0.0
NCT03759041,,2018-11-27,2022-05-24,,2022-07-19,2018-11-28,2018-11-29,ACTUAL,2022-05-24,2022-06-21,ACTUAL,,,,2022-07-19,2022-08-12,ACTUAL,2018-12-19,ACTUAL,2018-12-19,2022-07,2022-07-31,2021-10-13,ACTUAL,2021-10-13,2021-05-28,ACTUAL,2021-05-28,,INTERVENTIONAL,ECO-RESET,Intent-to-treat,A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis,"ECO-RESET: A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis",TERMINATED,,PHASE2,203.0,ACTUAL,"Seres Therapeutics, Inc.",,3.0,,"Due to the lack of a clinical efficacy signal in the induction treatment phase, Seres closed the dosing phases of open label and maintenance portions of the study. Patients who had received prior doses were followed for safety data.",f,,,,f,t,f,,,,,,,,,,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2021,0.0
NCT04977336,,2021-07-15,,2023-02-16,2023-02-16,2021-07-15,2021-07-26,ACTUAL,,,,,2023-02-27,ACTUAL,2023-02-16,2023-02-27,ACTUAL,2021-07-19,ACTUAL,2021-07-19,2023-02,2023-02-28,2022-03-04,ACTUAL,2022-03-04,2022-02-17,ACTUAL,2022-02-17,,INTERVENTIONAL,,,A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy,"A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy",COMPLETED,,PHASE2,274.0,ACTUAL,Vertex Pharmaceuticals Incorporated,,3.0,,,f,,,,,t,f,,,,,,,,,NO,Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing,2024-10-16 22:20:12.26436,2024-10-16 22:20:12.26436,INDUSTRY,,,,,,,2022,1.0
NCT05061277,,2021-09-20,,,2023-04-12,2021-09-20,2021-09-29,ACTUAL,,,,,,,2023-04-12,2023-04-18,ACTUAL,2023-10-25,ESTIMATED,2023-10-25,2023-04,2023-04-30,2024-06-16,ESTIMATED,2024-06-16,2023-12-12,ESTIMATED,2023-12-12,,INTERVENTIONAL,,,"Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Recifercept in Healthy Chinese Participants","A PHASE 1, OPEN-LABEL, SINGLE SUBCUTANEOUS DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF LYOPHILIZED FORMULATION OF RECIFERCEPT IN HEALTHY CHINESE PARTICIPANTS",WITHDRAWN,,PHASE1,0.0,ACTUAL,Pfizer,,1.0,,Pfizer has decided to cancel study C4181006 due to strategic considerations. This decision is not due to any specific reasons or requests from any regulatory authorities. No participants have been enrolled in this study.,f,,,,,t,f,,,t,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,INDUSTRY,,,,,,,2024,0.0
NCT06329687,,2024-03-19,,,2024-04-17,2024-03-19,2024-03-26,ACTUAL,,,,,,,2024-04-17,2024-04-18,ACTUAL,2024-02-21,ACTUAL,2024-02-21,2024-03,2024-03-31,2024-02-28,ACTUAL,2024-02-28,2024-02-28,ACTUAL,2024-02-28,,INTERVENTIONAL,,,A Study Evaluating the Safety of the Nasal Pump,"A Phase 4, Single-Center, Open-Label Study Evaluating the Safety of the Tyrvaya Nasal Pump",TERMINATED,,PHASE4,5.0,ACTUAL,"Oyster Point Pharma, Inc.",,1.0,,Internal strategy change. Not related to safety concerns.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,INDUSTRY,,,,,,,2024,0.0
NCT04810611,,2021-03-09,,,2024-05-15,2021-03-18,2021-03-23,ACTUAL,,,,,,,2024-05-15,2024-05-17,ACTUAL,2021-06-18,ACTUAL,2021-06-18,2024-05,2024-05-31,2024-04-19,ACTUAL,2024-04-19,2024-04-19,ACTUAL,2024-04-19,,INTERVENTIONAL,,,Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS,"A Phase Ib, Multicenter, Open-label Platform Study of Select Drug Combinations in Adult Patients With Lower Risk (Very Low, Low, or Intermediate Risk) Myelodysplastic Syndrome",TERMINATED,,PHASE1,33.0,ACTUAL,Novartis,,5.0,,Business reasons,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2024,0.0
NCT02757391,,2016-04-26,,,2020-10-28,2016-04-27,2016-05-02,ESTIMATED,,,,,,,2020-10-28,2020-10-30,ACTUAL,2019-08-09,ACTUAL,2019-08-09,2020-10,2020-10-31,2020-10-02,ACTUAL,2020-10-02,2020-10-02,ACTUAL,2020-10-02,,INTERVENTIONAL,,,CD8+ T Cell Therapy and Pembrolizumab in Treating Patients With Metastatic Gastrointestinal Tumors,Pilot Study of Feasibility and Safety of Personalized Autologous CD8+ T Cell Therapy Plus Anti-PD1 Antibody in Advanced Solid Malignancies,TERMINATED,,PHASE1,1.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,OTHER,,,,,,,2020,0.0
NCT04149574,,2019-10-31,,,2024-04-18,2019-10-31,2019-11-04,ACTUAL,,,,,,,2024-04-18,2024-04-19,ACTUAL,2020-01-15,ACTUAL,2020-01-15,2024-04,2024-04-30,2023-10-31,ACTUAL,2023-10-31,2023-10-31,ACTUAL,2023-10-31,,INTERVENTIONAL,CheckMate 7G8,,A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC),"A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG",TERMINATED,,PHASE3,13.0,ACTUAL,Bristol-Myers Squibb,,2.0,,"Insufficient enrollment, inability to meet protocol objectives, and slow accrual.",t,,,,f,t,f,,,,,,,,,,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,NCT03126643,APPROVED_FOR_MARKETING,,,,2023,0.0
NCT04197869,,2019-12-09,,,2023-09-20,2019-12-11,2019-12-13,ACTUAL,,,,,,,2023-09-20,2023-09-21,ACTUAL,2019-12-09,ACTUAL,2019-12-09,2023-09,2023-09-30,2023-06-21,ACTUAL,2023-06-21,2023-06-21,ACTUAL,2023-06-21,,INTERVENTIONAL,,,Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy,Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy: A Randomized Controlled Trial,COMPLETED,,PHASE4,48.0,ACTUAL,Northwell Health,,2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,OTHER,,,,,,,2023,0.0
NCT05052554,,2021-08-06,,,2022-05-05,2021-09-13,2021-09-22,ACTUAL,,,,,,,2022-05-05,2022-05-11,ACTUAL,2021-08-10,ACTUAL,2021-08-10,2022-05,2022-05-31,2022-04-12,ACTUAL,2022-04-12,2022-04-12,ACTUAL,2022-04-12,,INTERVENTIONAL,Fuchs Focus,,"Study With QR-504a to Evaluate Safety, Tolerability & Corneal Endothelium Molecular Biomarker(s) in Subjects With FECD3","Open-Label, Single-Dose, Exploratory Study With QR-504a to Evaluate Safety, Tolerability, and Corneal Endothelium Molecular Biomarker(s) in Subjects With Fuchs Endothelial Corneal Dystrophy With Trinucleotide Repeat Expansion in the TCF4 Gene (FECD3)",WITHDRAWN,,PHASE1,0.0,ACTUAL,ProQR Therapeutics,,2.0,,No patients,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,INDUSTRY,,,,,,,2022,0.0
NCT04448132,,2020-06-23,,,2021-06-21,2020-06-23,2020-06-25,ACTUAL,,,,,,,2021-06-21,2021-06-22,ACTUAL,2020-11-20,ACTUAL,2020-11-20,2021-06,2021-06-30,2021-05-03,ACTUAL,2021-05-03,2021-05-03,ACTUAL,2021-05-03,,INTERVENTIONAL,,,Evaluation of Persistence of Immunity in 4-year-old Children Previously Immunised With IPV-Al AJV (Picovax®),"Evaluation of the Persistence of the Immunity in 4-year-old Children Previously Immunised With an Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al AJV (Picovax®) by Measuring the Response to an Additional Dose of IPV-Al AJV",COMPLETED,,PHASE4,163.0,ACTUAL,AJ Vaccines A/S,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,INDUSTRY,,,,,,,2021,1.0
NCT04585776,,2020-10-08,2022-05-06,,2022-05-06,2020-10-08,2020-10-14,ACTUAL,2022-05-06,2022-06-03,ACTUAL,,,,2022-05-06,2022-06-03,ACTUAL,2020-10-30,ACTUAL,2020-10-30,2022-05,2022-05-31,2021-05-27,ACTUAL,2021-05-27,2021-05-27,ACTUAL,2021-05-27,,INTERVENTIONAL,,All enrolled participants.,A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes,An Exploratory Study Assessing Time in Target Glucose Range Using a New Titration Scheme of LY900014 and Insulin Degludec in Patients With Type 1 Diabetes,COMPLETED,,PHASE2,31.0,ACTUAL,Eli Lilly and Company,,1.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,INDUSTRY,,,,,,,2021,1.0
NCT03852628,,2019-02-12,2023-04-19,,2023-09-01,2019-02-21,2019-02-25,ACTUAL,2023-05-16,2023-06-07,ACTUAL,,,,2023-09-01,2023-09-14,ACTUAL,2019-05-20,ACTUAL,2019-05-20,2023-04,2023-04-30,2023-01-30,ACTUAL,2023-01-30,2022-05-02,ACTUAL,2022-05-02,,INTERVENTIONAL,,,Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD,Kappa Opioid Receptor Antagonism for the Treatment of Alcohol Use Disorder (AUD) and Comorbid Post-Traumatic Stress Disorder (PTSD),TERMINATED,,PHASE2,69.0,ACTUAL,Pharmacotherapies for Alcohol and Substance Use Disorders Alliance,There are no secondary outcome results to report as this study was closed for futility before enough data was collected to report secondary outcomes. .,2.0,,Futility analysis,f,,,,t,t,f,,,,,,,,,YES,CDMRP has a policy to share and make available to the public the results and accomplishments of the activities that it funds. The PASA consortium plans to share de-identified data after final publication in a government-supported data repository.,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,OTHER,,,,,,,2023,0.0
NCT05668936,,2022-12-20,,,2023-04-01,2022-12-20,2022-12-30,ACTUAL,,,,,,,2023-04-01,2023-04-05,ACTUAL,2023-01-03,ACTUAL,2023-01-03,2023-03,2023-03-31,2023-03-10,ACTUAL,2023-03-10,2023-03-10,ACTUAL,2023-03-10,,INTERVENTIONAL,,,A Thorough QTC Study to Assess the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants,"A Thorough QTc Evaluation of the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants: A Randomized, Double-blind, Placebo-controlled, 3-arm Parallel Study With a Nested Crossover Design for Positive Control With Moxifloxacin Administration",TERMINATED,,PHASE1,31.0,ACTUAL,AstraZeneca,,3.0,,"Discontinuing the development of cotadutide, a daily injectable GLP-1/glucagon co-agonist, is based on strategic pipeline considerations. The premature closure is not due to any newly observed safety signals or a change in the risk/benefit profile.",f,,,,,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,INDUSTRY,,,,,,,2023,0.0
NCT03443622,,2018-02-07,,,2020-10-19,2018-02-17,2018-02-23,ACTUAL,,,,,,,2020-10-19,2020-10-22,ACTUAL,2021-05,ESTIMATED,2021-05-31,2020-10,2020-10-31,2023-06,ESTIMATED,2023-06-30,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Phase I Study of SC-43 Oral Solution in Subjects With Refractory Solid Tumors,"Phase I Open-Label Dose-Escalating Study to Determine the Safety, Tolerability, Maximum Tolerated Dose, and Pharmacokinetics of SC-43 Oral Solution in Subjects With Refractory Solid Tumors",WITHDRAWN,,PHASE1,0.0,ACTUAL,SupremeCure Pharma Inc.,,6.0,,Another study has been started in other country.,f,,,,,f,f,,,,,,,,,,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,INDUSTRY,,,,,,,2023,0.0
NCT03364764,,2017-11-21,,,2021-07-01,2017-12-01,2017-12-07,ACTUAL,,,,,,,2021-07-01,2021-07-06,ACTUAL,2018-02-01,ACTUAL,2018-02-01,2020-06,2020-06-30,2021-05-01,ACTUAL,2021-05-01,2019-02-01,ACTUAL,2019-02-01,,INTERVENTIONAL,,,Sirolimus Treatment for Refractory PRCA,"Sirolimus Treatment for Refractory Pure Red Cell Aplasia, a Prospective Study",COMPLETED,,PHASE4,64.0,ACTUAL,Peking Union Medical College Hospital,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,OTHER,,,,,,,2021,1.0
NCT03577028,,2018-06-22,2023-11-14,,2024-01-18,2018-06-22,2018-07-05,ACTUAL,2024-01-18,2024-02-14,ACTUAL,,,,2024-01-18,2024-02-14,ACTUAL,2018-07-24,ACTUAL,2018-07-24,2024-01,2024-01-31,2023-02-27,ACTUAL,2023-02-27,2023-02-27,ACTUAL,2023-02-27,,INTERVENTIONAL,,"Safety Population. The study was terminated early, therefore the primary goal of the final data analysis was to look at dosing schedule rather than individual dose levels. The results displayed are shown broken out by dosing schedules and no analysis of specific dose levels was performed. This analysis is as outlined in the final Statistical Analysis Plan.",Study of HPN424 in Patients With Advanced Prostate Cancer,"A Phase 1/2a Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN424 in Patients With Advanced Prostate Cancer Refractory to Androgen Therapy",TERMINATED,,PHASE1/PHASE2,104.0,ACTUAL,"Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)",,6.0,,Decision not to continue to the expansion portion of the study,f,,,,f,t,f,,,,,,,,,,,2024-10-16 10:46:19.641007,2024-10-16 10:46:19.641007,INDUSTRY,,,,,,,2023,0.0
NCT03092895,,2017-03-15,,,2023-02-06,2017-03-22,2017-03-28,ACTUAL,,,,,,,2023-02-06,2023-02-08,ACTUAL,2017-04-27,ACTUAL,2017-04-27,2022-04,2022-04-30,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,,,A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC,A Phase 2 Study of SHR-1210 (PD-1 Antibody) in Combination With Apatinib or Chemotherapy (FOLFOX4 or GEMOX) in Subjects With Advanced Primary Liver Cancer（PLC）or Biliary Tract Carcinoma (BTC),COMPLETED,,PHASE2,157.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,INDUSTRY,,,,,,,2021,1.0
NCT04054973,,2019-08-02,,,2022-01-04,2019-08-09,2019-08-13,ACTUAL,,,,,,,2022-01-04,2022-01-20,ACTUAL,2019-09-11,ACTUAL,2019-09-11,2022-01,2022-01-31,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,L-arginine Study for Persistent Symptoms of Schizophrenia,An Open-label Feasibility Trial of Adjunctive L-arginine and Tetrahydrobiopterin Combination in Patients With Treatment Resistant Schizophrenia,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of Massachusetts, Worcester",,1.0,,Study was unable to be started due to unavailability of study medication.,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,OTHER,,,,,,,2021,0.0
NCT05956509,,2023-07-14,,,2024-06-28,2023-07-14,2023-07-21,ACTUAL,,,,,,,2024-06-28,2024-07-01,ACTUAL,2024-01-12,ACTUAL,2024-01-12,2024-06,2024-06-30,2024-06-02,ACTUAL,2024-06-02,2024-06-02,ACTUAL,2024-06-02,,INTERVENTIONAL,,,Study of Intramuscular Injections of ABBV-950 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Spasticity,"A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Efficacy, and Tolerability of ABBV-950 for the Treatment of Upper Limb Spasticity in Adult Post-Stroke Patients",TERMINATED,,PHASE1,1.0,ACTUAL,AbbVie,,11.0,,Strategic considerations,f,,,,t,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.",2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2024,0.0
NCT04376827,,2020-05-04,2024-02-01,,2024-03-21,2020-05-04,2020-05-06,ACTUAL,2024-03-21,2024-04-16,ACTUAL,,,,2024-03-21,2024-04-16,ACTUAL,2020-09-15,ACTUAL,2020-09-15,2024-03,2024-03-31,2023-02-01,ACTUAL,2023-02-01,2023-02-01,ACTUAL,2023-02-01,,INTERVENTIONAL,ORCHID-LN,,A Study of Guselkumab in Participants With Active Lupus Nephritis,"A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects With Active Lupus Nephritis",TERMINATED,,PHASE2,33.0,ACTUAL,"Janssen Research & Development, LLC","Due to enrollment challenges, the Sponsor decided to stop screening of new participants and stop the study early. Since a small number of participants only entered the LTE phase than the planned enrollment count, some of the planned safety analyses were not performed for the LTE phase participants.",2.0,,"Due to enrollment challenges, J\&J Innovative Medicine decided to stop screening and terminate the study early. This decision was not based on a safety concern.",f,,,,t,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2023,0.0
NCT05161481,,2021-12-06,,,2024-10-01,2021-12-06,2021-12-17,ACTUAL,,,,,,,2024-10-01,2024-10-02,ACTUAL,2022-02-03,ACTUAL,2022-02-03,2024-09,2024-09-30,2024-06-12,ACTUAL,2024-06-12,2024-05-02,ACTUAL,2024-05-02,,INTERVENTIONAL,,,A Study to Test Whether Two Different Doses of Avenciguat Help People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Live,"Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Investigate the Effects of Two Doses (Up-titration to a Fixed Dose Regimen) of Oral BI 685509 on Portal Hypertension After 24 Weeks Treatment in Patients With Clinically Significant Portal Hypertension (CSPH) in Compensated Cirrhosis",TERMINATED,,PHASE2,80.0,ACTUAL,Boehringer Ingelheim,,3.0,,Company decision,f,,,,t,t,f,,,,,,"After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.",https://www.mystudywindow.com/msw/datasharing,YES,"Once the time frame criteria given under number 4 are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.",2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,INDUSTRY,,,,,,,2024,0.0
NCT04465760,,2020-06-25,2023-11-07,,2024-01-20,2020-07-07,2020-07-10,ACTUAL,2023-12-29,2024-01-02,ACTUAL,,,,2024-01-20,2024-01-24,ACTUAL,2021-02-25,ACTUAL,2021-02-25,2024-01,2024-01-31,2021-11-05,ACTUAL,2021-11-05,2021-10-05,ACTUAL,2021-10-05,,INTERVENTIONAL,,,Xisomab 3G3 for the Prevention of Catheter-Associated Thrombosis in Patients With Cancer Receiving Chemotherapy,"A Phase II Study of Xisomab 3G3, a Monoclonal Antibody Preventing the Activation of FXI by FXIIa, for the Prophylaxis of Catheter-Associated Thrombosis",TERMINATED,,PHASE2,9.0,ACTUAL,OHSU Knight Cancer Institute,Early termination leading to small numbers of subjects analyzed.,1.0,,Insufficient accrual rate,,,,,t,t,f,,,,,,,,,,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,OTHER,,,,,,,2021,0.0
NCT05375955,,2022-05-11,2024-07-23,,2024-09-06,2022-05-11,2022-05-17,ACTUAL,2024-09-06,2024-10-02,ACTUAL,,,,2024-09-06,2024-10-02,ACTUAL,2022-09-26,ACTUAL,2022-09-26,2024-09,2024-09-30,2023-07-31,ACTUAL,2023-07-31,2023-07-31,ACTUAL,2023-07-31,,INTERVENTIONAL,,Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention.,A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.,"A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MULTIPLE DOSE LEVELS OF PF-07038124 OINTMENT FOR 12 WEEKS IN PARTICIPANTS 12 YEARS AND OLDER AND WITH MILD-TO-MODERATE ATOPIC DERMATITIS OR MILD-TO-SEVERE PLAQUE PSORIASIS",COMPLETED,,PHASE2,263.0,ACTUAL,Pfizer,,7.0,,,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,INDUSTRY,,,,,,,2023,1.0
NCT04268823,,2020-01-29,2023-09-07,,2024-06-17,2020-02-11,2020-02-13,ACTUAL,2023-09-07,2023-10-04,ACTUAL,,,,2024-06-17,2024-06-20,ACTUAL,2020-09-10,ACTUAL,2020-09-10,2024-06,2024-06-30,2022-09-20,ACTUAL,2022-09-20,2022-09-13,ACTUAL,2022-09-13,,INTERVENTIONAL,,,Clinical Study to Assess the Mode of Action of QBW251 in Patients With Chronic Obstructive Pulmonary Disease (COPD),"A Randomized, Subjects and Investigator Blinded, Placebo Controlled Parallel Group Study to Assess the Mode of Action of QBW251 in Patients With Chronic Obstructive Pulmonary Disease (COPD)",TERMINATED,,PHASE2,54.0,ACTUAL,Novartis,,2.0,,Sponsor decision,,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,INDUSTRY,,,,,,,2022,0.0
NCT05943990,,2023-07-05,2023-09-01,,2023-09-01,2023-07-05,2023-07-13,ACTUAL,2023-09-01,2024-03-18,ACTUAL,,,,2023-09-01,2024-03-18,ACTUAL,2020-12-21,ACTUAL,2020-12-21,2023-09,2023-09-30,2022-10-24,ACTUAL,2022-10-24,2022-10-24,ACTUAL,2022-10-24,,INTERVENTIONAL,,,Study of GSK3845097 in Previously Treated Participants With Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma,"Assessment of Safety and Recommended Phase 2 Dose of Autologous T Cells Engineered With an Affinity-enhanced TCR Targeting NY ESO 1 and LAGE 1a, and Co-expressing the dnTGF-βRII (GSK3845097) in Participants With NY ESO 1 and/or LAGE 1a Positive Previously Treated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma",TERMINATED,,PHASE1,5.0,ACTUAL,GlaxoSmithKline,,1.0,,The study was terminated due to a change in GSK's R\&D priorities.,f,,,,f,t,f,,,,,,"Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",http://www.gsk.com/en-gb/innovation/trials/data-transparency/,YES,Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2022,0.0
NCT04491136,,2020-06-22,,,2024-02-20,2020-07-28,2020-07-29,ACTUAL,,,,,,,2024-02-20,2024-02-21,ACTUAL,2020-11-11,ACTUAL,2020-11-11,2024-02,2024-02-29,2023-06-08,ACTUAL,2023-06-08,2023-06-08,ACTUAL,2023-06-08,,INTERVENTIONAL,RHYTHM,,Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM),"A Multicenter, Interventional, Open-label and Single-arm Study to Investigate the Effect of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D",TERMINATED,,PHASE4,201.0,ACTUAL,Novartis,,1.0,,Company decision,f,,,,,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2023,0.0
NCT04448834,,2020-06-22,,,2022-02-14,2020-06-24,2020-06-26,ACTUAL,,,,,,,2022-02-14,2022-03-02,ACTUAL,2022-01,ESTIMATED,2022-01-31,2022-02,2022-02-28,2023-06-01,ESTIMATED,2023-06-01,2023-06-01,ESTIMATED,2023-06-01,,INTERVENTIONAL,,,Blincyto Amgen Acrotech BioPharma PH2 Blincyto Marqibo R/R Philadelphi CD19+ ALL,"A Phase 2 Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE® Antibody Blinatumomab (Blincyto) and Vincristine Sulfate Liposomal Injection (Marqibo) in Adult Subjects With Relapsed/Refractory Philadelphia Negative CD19+ Acute Lymphoblastic Leukemia",WITHDRAWN,,PHASE2,0.0,ACTUAL,Duke University,,1.0,,Study not moving forward,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,OTHER,,,,,,,2023,0.0
NCT02255305,,2014-09-30,2022-11-11,,2023-02-01,2014-09-30,2014-10-02,ESTIMATED,2023-02-01,2023-03-03,ACTUAL,,,,2023-02-01,2023-03-03,ACTUAL,2015-01,,2015-01-31,2023-02,2023-02-28,2020-01,ACTUAL,2020-01-31,2020-01,ACTUAL,2020-01-31,,INTERVENTIONAL,,,FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI,Fecal Microbiota Transplantation Versus Standard Medical Therapy for Initial Treatment of Recurrent Clostridium Difficile Infection,TERMINATED,,PHASE2,6.0,ACTUAL,NorthShore University HealthSystem,"Study ended early due to personnel needed for study completion (enrollment, follow-up, FMT procedure) and did not reach enrollment goals.",2.0,,"Due to personnel issues for finding and enrolling patients, performing appropriate follow-up and performing FMT procedure",f,,,,t,,,,,,,,,,,,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,OTHER,,,,,,,2020,0.0
NCT03585101,,2018-06-29,,,2018-08-03,2018-06-29,2018-07-12,ACTUAL,,,,,,,2018-08-03,2018-08-07,ACTUAL,2018-08,ESTIMATED,2018-08-31,2018-08,2018-08-31,2020-04,ESTIMATED,2020-04-30,2019-06,ESTIMATED,2019-06-30,,INTERVENTIONAL,HEART-C,,A Single-arm Evaluation of the Effect of HCV Treatment on Cardiovascular Disease Risk,A Single-arm Evaluation of the Effect of Elbasvir/Grazoprevir on Cardiometabolic Parameters in Patients With Hepatitis C Infection and Underlying Metabolic Disease,WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of California, Los Angeles",,1.0,,Funding no longer available,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,OTHER,,,,,,,2020,0.0
NCT04788511,,2021-03-05,2024-04-18,,2024-06-08,2021-03-05,2021-03-09,ACTUAL,2024-06-08,2024-06-11,ACTUAL,,,,2024-06-08,2024-06-11,ACTUAL,2021-03-16,ACTUAL,2021-03-16,2024-06,2024-06-30,2023-04-18,ACTUAL,2023-04-18,2023-04-18,ACTUAL,2023-04-18,,INTERVENTIONAL,STEP-HFpEF,Full analysis set (FAS) population included all the randomized participants for this trial.,Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity,Effect of Semaglutide 2.4 mg Once Weekly on Function and Symptoms in Subjects With Obesity-related Heart Failure With Preserved Ejection Fraction,COMPLETED,,PHASE3,529.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,INDUSTRY,,,,,,,2023,1.0
NCT03404726,,2017-11-29,,,2021-12-20,2018-01-12,2018-01-19,ACTUAL,,,,,,,2021-12-20,2022-01-11,ACTUAL,2018-03-29,ACTUAL,2018-03-29,2021-12,2021-12-31,2021-01-26,ACTUAL,2021-01-26,2021-01-26,ACTUAL,2021-01-26,,INTERVENTIONAL,,,"A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies","An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies",TERMINATED,,PHASE1,40.0,ACTUAL,Bayer,,3.0,,Lack of sufficient clinical benefit,f,,,,f,t,f,,,,,,,,,,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,INDUSTRY,,,,,,,2021,0.0
NCT02960763,,2016-10-28,2022-02-01,,2024-09-18,2016-11-07,2016-11-10,ESTIMATED,2022-05-20,2022-05-24,ACTUAL,,,,2024-09-18,2024-10-03,ACTUAL,2017-02-24,ACTUAL,2017-02-24,2024-09,2024-09-30,2021-09-01,ACTUAL,2021-09-01,2020-09-28,ACTUAL,2020-09-28,,INTERVENTIONAL,OPTIMUM,"In Participant Flow, Step 2 milestones shows numbers recorded for those who switched from Step 1 to Step 2, and the numbers for those who started Step 2 without having first participated in Step 1.~125 participants from the Step 1 arms (aripiprazole augmentation, bupropion augmentation, and switch to bupropion) also participated in Step 2.~A grand total of 742 unique participants were randomized in the study.",Optimizing Outcomes of Treatment-Resistant Depression in Older Adults,Optimizing Outcomes of Treatment-Resistant Depression in Older Adults,COMPLETED,,PHASE4,742.0,ACTUAL,Washington University School of Medicine,,5.0,,,f,,,,t,t,f,,,f,,,,,,YES,"A cleaned, complete, and de-identified copy of the final data set including administrative and technical metadata records will be made available through a Washington University in St. Louis (WUSTL) secure repository and registered at clinicaltrials.gov.",2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,OTHER,,,,,,,2021,1.0
NCT03691779,,2018-09-28,2021-08-06,,2021-09-24,2018-09-28,2018-10-02,ACTUAL,2021-09-24,2021-10-22,ACTUAL,,,,2021-09-24,2021-10-22,ACTUAL,2018-10-02,ACTUAL,2018-10-02,2021-08,2021-08-31,2020-08-07,ACTUAL,2020-08-07,2020-08-07,ACTUAL,2020-08-07,,INTERVENTIONAL,,The analysis population included all enrolled participants who carry the intended CFTR allele mutation and received at least 1 dose of study drug in the respective part of the study.,Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age,"A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age",COMPLETED,,PHASE3,71.0,ACTUAL,Vertex Pharmaceuticals Incorporated,,2.0,,,t,,,,,t,f,,,,,,,,,,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,NCT04058210,APPROVED_FOR_MARKETING,,,,2020,1.0
NCT03467217,,2018-03-09,2021-05-30,,2021-09-23,2018-03-14,2018-03-15,ACTUAL,2021-09-23,2021-10-21,ACTUAL,,,,2021-09-23,2021-10-21,ACTUAL,2018-10-02,ACTUAL,2018-10-02,2021-09,2021-09-30,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,STOP-NAFLD,,Losartan for the Treatment of Pediatric NAFLD,"Losartan for the Treatment of Pediatric NAFLD (STOP-NAFLD): A Phase 2, Randomized, Placebo-Controlled Clinical Trial",TERMINATED,,PHASE2,83.0,ACTUAL,National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),,2.0,,Trial stopped for futility,f,,,,t,t,f,,,f,,,Data from this study may be requested from the NIDDK Central Repository (https://www.niddkrepository.org/search/study/) two years after the completion of the primary outcome.,Apply through the NIDDK Central Repository:,https://repository.niddk.nih.gov/home/,YES,This study will comply with the NIH Data Sharing Policy and Results information from this trial will be submitted to ClinicalTrials.gov and a public use database deposited with the NIDDK Central Repository.,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,NIH,,,,,,,2020,0.0
NCT02636946,,2015-12-10,2022-01-25,,2022-02-22,2015-12-18,2015-12-22,ESTIMATED,2022-02-22,2022-02-23,ACTUAL,,,,2022-02-22,2022-02-23,ACTUAL,2016-02-24,ACTUAL,2016-02-24,2022-02,2022-02-28,2021-01-26,ACTUAL,2021-01-26,2021-01-26,ACTUAL,2021-01-26,,INTERVENTIONAL,,Intent-to-treat (ITT) Population was defined as all randomized participants.,A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension,A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension,COMPLETED,,PHASE3,144.0,ACTUAL,Allergan,,2.0,,,f,,,,f,t,f,,,,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2021,1.0
NCT00896181,,2009-05-07,2021-02-03,,2021-03-10,2009-05-08,2009-05-11,ESTIMATED,2021-03-10,2021-04-06,ACTUAL,,,,2021-03-10,2021-04-06,ACTUAL,2008-12-10,ACTUAL,2008-12-10,2021-03,2021-03-31,2020-12,ACTUAL,2020-12-31,2020-01-03,ACTUAL,2020-01-03,,INTERVENTIONAL,,,Phase 2 Sequential and Concurrent Chemoradiation for Advanced Nasopharyngeal Carcinoma (NPC),A Phase 2 Study of Sequential and Concurrent Chemoradiation for Patients With Advanced Nasopharyngeal Carcinoma (NPC),COMPLETED,,PHASE2,26.0,ACTUAL,Stanford University,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,OTHER,,,,,,,2020,1.0
NCT02973191,,2016-11-22,,,2017-04-07,2016-11-22,2016-11-25,ESTIMATED,,,,,,,2017-04-07,2017-04-10,ACTUAL,2016-12-20,ESTIMATED,2016-12-20,2017-04,2017-04-30,2021-01-24,ESTIMATED,2021-01-24,2019-06-25,ESTIMATED,2019-06-25,,INTERVENTIONAL,ORBIT,,"A Study to Determine Safety, Feasibility and Efficacy of JCAR015 in Adult Subjects With B-Cell Acute Lymphoblastic Leukemia","A Phase 2, Open-label, Multiple Cohort, Single-arm, Multi-center Trial to Determine the Safety, Feasibility and Efficacy of JCAR015 in Adult Subjects With B-cell Acute Lymphoblastic Leukemia.",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Celgene,,1.0,,Development of JCAR015 has been discontinued. No subjects were enrolled/treated under protocol JCAR015-ALL-001,f,,,,t,,,,,,,,,,,,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,INDUSTRY,,,,,,,2021,0.0
NCT04531462,,2020-08-26,2023-08-14,,2024-04-11,2020-08-26,2020-08-28,ACTUAL,2023-08-14,2024-03-12,ACTUAL,,,,2024-04-11,2024-05-02,ACTUAL,2020-10-05,ACTUAL,2020-10-05,2024-04,2024-04-30,2022-08-26,ACTUAL,2022-08-26,2022-08-19,ACTUAL,2022-08-19,,INTERVENTIONAL,,"Full Analysis Set (FAS): This set included all patients randomised, treated with at least one dose of trial medication, and with a baseline and at least one on-treatment glycated haemoglobin (HbA1c) value.",A Study to Test How Well Empagliflozin Works in Japanese People With Type 2 Diabetes Who Are Older Than 65 Years,"A Randomised, Double-blind, Placebo-controlled, Parallel Group, 52 Weeks Phase IV Trial to Evaluate Efficacy and Safety of Oral, Once Daily Empagliflozin in Elderly Japanese Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control",COMPLETED,,PHASE4,129.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,f,f,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'.For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.",2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,INDUSTRY,,,,,,,2022,1.0
NCT05279235,,2022-03-08,,,2023-02-06,2022-03-14,2022-03-15,ACTUAL,,,,,,,2023-02-06,2023-02-08,ACTUAL,2022-03-14,ACTUAL,2022-03-14,2022-02,2022-02-28,2022-12-15,ACTUAL,2022-12-15,2022-12-15,ACTUAL,2022-12-15,,INTERVENTIONAL,,,Efficacy and Safety of JT001 (VV116) Compared With Favipiravir,"A Multi-center, Double-blinded, Randomized, Phase III Study to Evaluate the Efficacy and Safety of JT001 (VV116) Compared With Favipiravir in Participants With Moderate to Severe Coronavirus Disease 2019 (COVID-19)",TERMINATED,,PHASE3,290.0,ACTUAL,"Shanghai Vinnerna Biosciences Co., Ltd.",,2.0,,Development strategy adjustment,f,,,,f,f,f,,,,,,,,,UNDECIDED,Undecided,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,INDUSTRY,,,,,,,2022,0.0
NCT03489512,,2018-03-14,,,2020-06-10,2018-04-04,2018-04-05,ACTUAL,,,,,,,2020-06-10,2020-06-11,ACTUAL,2019-10-01,ESTIMATED,2019-10-01,2019-08,2019-08-31,2021-04-01,ESTIMATED,2021-04-01,2020-10-01,ESTIMATED,2020-10-01,,INTERVENTIONAL,,,Comparison Trial for Chloraprep Versus Aqueous Chlorhexidine (2%) for the Prevention of Catheter-related Bacteremia,Clinical Phase IV Comparison Trial for 2% Chlorhexidine Skin Asepsis +70% Alcohol Versus Aqueous Chlorhexidine (2%) for the Prevention of Catheter-related Bacteremia in Critical Patients: Preliminary Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,Instituto de Investigacion Sanitaria La Fe,,2.0,,Administrative issues,f,,,,f,f,f,,,,,,,,,,,2024-10-15 00:52:42.601721,2024-10-15 00:52:42.601721,OTHER,,,,,,,2021,0.0
NCT03463915,,2018-02-28,2021-06-25,,2021-08-08,2018-03-06,2018-03-13,ACTUAL,2021-08-08,2021-09-01,ACTUAL,,,,2021-08-08,2021-09-01,ACTUAL,2019-01-25,ACTUAL,2019-01-25,2021-08,2021-08-31,2020-10-23,ACTUAL,2020-10-23,2020-10-23,ACTUAL,2020-10-23,,INTERVENTIONAL,,,Clinical Trial Comparing Two Bladder Instillations for IC/BPS,Randomized Controlled Trial Comparing Two Different Bladder Instillation Treatments for Interstitial Cystitis/Bladder Pain Syndrome,COMPLETED,,PHASE3,90.0,ACTUAL,University of Louisville,,2.0,,,f,,,,,t,f,,,t,,,Data will be available beginning 1 month and ending 24 months following article publication.,"Available to investigators whose proposed use of the data is for individual participant data meta-analysis and has been approved by an independent review committee for this purpose. To gain access, data requestors will need to sign a data access agreement.",,YES,De-identified raw data and other supporting materials will be made available to approved investigators. Email requests to olivia.cardenas-trowers@louisville.edu.,2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,OTHER,,,,,,,2020,0.0
NCT03087097,,2016-12-12,,,2021-01-11,2017-03-15,2017-03-22,ACTUAL,,,,,,,2021-01-11,2021-01-13,ACTUAL,2019-04-11,ACTUAL,2019-04-11,2021-01,2021-01-31,2020-07-21,ACTUAL,2020-07-21,2020-07-21,ACTUAL,2020-07-21,,INTERVENTIONAL,THRIVE,,Transfer of Healthy Gut Flora for Restoration of Intestinal Microbiota Via Enema for Patients in the Rehabilitative Phase of Malnutrition,"Transfer of Healthy Gut Flora for Restoration of Intestinal Microbiota Via Enema (THRIVE) for Patients in the Rehabilitative Phase of Malnutrition: A Pilot Study Evaluating Microbial Engraftment, Safety and Nutritional Outcomes",TERMINATED,,PHASE1,5.0,ACTUAL,Microbiome Health Research Institute,,2.0,,COVID-19 pandemic and resource constraints,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,OTHER,,,,,,,2020,0.0
NCT05624320,,2022-11-14,,,2024-04-05,2022-11-14,2022-11-22,ACTUAL,,,,,,,2024-04-05,2024-04-09,ACTUAL,2022-12-01,ESTIMATED,2022-12-01,2022-11,2022-11-30,2023-06-30,ESTIMATED,2023-06-30,2023-05-30,ESTIMATED,2023-05-30,,INTERVENTIONAL,,,"Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses","Improved Near Vision and Intermediate Without Loss of Binocular Distance Vision Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses for Distance Vision Correction in Both Eyes",WITHDRAWN,,PHASE4,0.0,ACTUAL,Gordon Schanzlin New Vision,,1.0,,Lack of interest,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,OTHER,,,,,,,2023,0.0
NCT04528927,,2020-05-06,,,2020-08-26,2020-08-26,2020-08-27,ACTUAL,,,,,,,2020-08-26,2020-08-27,ACTUAL,2020-05-15,ESTIMATED,2020-05-15,2020-08,2020-08-31,2020-07-15,ESTIMATED,2020-07-15,2020-07-15,ESTIMATED,2020-07-15,,INTERVENTIONAL,THINC,,"Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Acute Respiratory Failure, in Tunisia","Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Acute Respiratory Failure, in Tunisia Multicentric Randomized Comparative Study",WITHDRAWN,,PHASE3,0.0,ACTUAL,Abderrahmane Mami Hospital,,3.0,,- Interest in the use of HCQ is controversial.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,OTHER,,,,,,,2020,0.0
NCT02613169,,2015-09-16,2020-11-12,,2023-03-31,2015-11-19,2015-11-24,ESTIMATED,2021-05-15,2021-06-10,ACTUAL,,,,2023-03-31,2023-04-28,ACTUAL,2016-08,,2016-08-31,2023-03,2023-03-31,2020-12,ACTUAL,2020-12-31,2019-10,ACTUAL,2019-10-31,,INTERVENTIONAL,iTIPS,,Infant TB Infection Prevention Study,Preventing Mycobacterium Tuberculosis Infection in HIV-Exposed Infants,COMPLETED,,PHASE2,300.0,ACTUAL,University of Washington,,2.0,,,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,OTHER,,,,,,,2020,0.0
NCT03327064,,2017-10-26,,,2024-08-06,2017-10-26,2017-10-31,ACTUAL,,,,,,,2024-08-06,2024-08-07,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2024-08,2024-08-31,2023-08-31,ACTUAL,2023-08-31,2023-08-31,ACTUAL,2023-08-31,,INTERVENTIONAL,,,A Biomarker Evaluation Trial of UAB30 in Renal Transplant Recipients at High Risk for Non-melanoma Skin Cancer,A Biomarker Evaluation Trial of UAB30 in Renal Transplant Recipients at High Risk for Non-melanoma Skin Cancer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Alabama at Birmingham,,2.0,,"COVID-19 pandemic, unable to enroll participants",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,OTHER,,,,,,,2023,0.0
NCT03363763,,2017-12-01,,,2023-03-28,2017-12-01,2017-12-06,ACTUAL,,,,,,,2023-03-28,2023-03-30,ACTUAL,2017-04-12,ACTUAL,2017-04-12,2023-03,2023-03-31,2023-03-24,ACTUAL,2023-03-24,2023-03-24,ACTUAL,2023-03-24,,INTERVENTIONAL,,,Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis Complex,Phase 2 Multi Center Prospective Rand. Double Blind Placebo Cont. Parallel Design Study to Evaluate Safety & Efficacy of Topical Sirolimus for Cutaneous Angiofibromas in Subjects W/ Tuberous Sclerosis Complex Followed by Opt. Open Label,TERMINATED,,PHASE2,24.0,ACTUAL,"Aucta Pharmaceuticals, Inc",,3.0,,Terminated (The clinical trial has ended prematurely due to low patient recruitment),f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,INDUSTRY,,,,,,,2023,0.0
NCT04183738,,2019-11-28,,,2020-11-08,2019-11-28,2019-12-03,ACTUAL,,,,,,,2020-11-08,2020-11-10,ACTUAL,2021-02-01,ESTIMATED,2021-02-01,2020-11,2020-11-30,2022-12-19,ESTIMATED,2022-12-19,2022-12-19,ESTIMATED,2022-12-19,,INTERVENTIONAL,i2-D²EFT,,Inflammation and Co-Infections in D²EFT,The Impact of Co-infections on Inflammation in Patients Commencing Second-line Antiretroviral Therapy. A Sub-study of D²EFT (Dolutegravir and Darunavir Evaluation in Adults Failing Therapy),WITHDRAWN,,PHASE4,0.0,ACTUAL,Kirby Institute,,3.0,,In the context of COVID-19 pandemic.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,OTHER_GOV,,,,,,,2022,0.0
NCT04943692,,2021-06-21,,,2021-06-21,2021-06-21,2021-06-29,ACTUAL,,,,,,,2021-06-21,2021-06-29,ACTUAL,2021-08,ESTIMATED,2021-08-31,2021-06,2021-06-30,2021-08,ESTIMATED,2021-08-31,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,COMETII,,Efficacy and Safety of Metformin Glycinate Compared to Metformin Hydrochloride on the Progression of Type 2 Diabetes,Efficacy and Safety of Metformin Glycinate Compared to Metformin Hydrochloride on the Progression of Type 2 Diabetes,SUSPENDED,,PHASE3,500.0,ESTIMATED,Laboratorios Silanes S.A. de C.V.,,2.0,,Administrative decision of the investigation direction,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,INDUSTRY,,,,,,,2021,0.0
NCT04223635,,2020-01-06,2021-05-11,,2021-06-11,2020-01-07,2020-01-10,ACTUAL,2021-05-11,2021-06-07,ACTUAL,,,,2021-06-11,2021-06-22,ACTUAL,2020-01-07,ACTUAL,2020-01-07,2021-06,2021-06-30,2020-10-02,ACTUAL,2020-10-02,2020-10-02,ACTUAL,2020-10-02,,INTERVENTIONAL,,Baseline characteristics were assessed using the Safety Analysis Set.,Study of Pexidartinib in Participants With Moderate Hepatic Impairment Compared With Healthy Participants,"An Open-label, Single-dose Study to Assess the Pharmacokinetics of Pexidartinib in Subjects With Moderate Hepatic Impairment Compared to Healthy Subjects",COMPLETED,,EARLY_PHASE1,16.0,ACTUAL,Daiichi Sankyo,,2.0,,,f,,,,f,t,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,INDUSTRY,,,,,,,2020,1.0
NCT03545997,,2018-05-16,,,2021-02-15,2018-06-04,2018-06-06,ACTUAL,,,,,,,2021-02-15,2021-02-17,ACTUAL,2019-11-29,ACTUAL,2019-11-29,2021-02,2021-02-28,2020-03-20,ACTUAL,2020-03-20,2020-03-20,ACTUAL,2020-03-20,,INTERVENTIONAL,MONTSAS,,Montelukast for Patients With Obstructive Sleep Apnea Syndrome,Impact of Blocked Cysteinyl Leukotriene Pathway on Endothelial Function in Patients With Obstructive Sleep Apnea Syndrome: Multicenter Randomized Placebo Controlled Crossover Trial,TERMINATED,,PHASE3,1.0,ACTUAL,"University Hospital, Grenoble",,2.0,,lack of recruitment,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,OTHER,,,,,,,2020,0.0
NCT02519777,,2015-08-06,2021-12-17,2020-01-15,2022-04-20,2015-08-06,2015-08-11,ESTIMATED,2022-02-04,2022-03-02,ACTUAL,2020-01-15,2020-02-05,ACTUAL,2022-04-20,2022-04-22,ACTUAL,2016-04-21,ACTUAL,2016-04-21,2022-04,2022-04-30,2021-01-05,ACTUAL,2021-01-05,2019-12-02,ACTUAL,2019-12-02,,INTERVENTIONAL,,All participants were included in the analysis.,Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND),"A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification With Maraviroc and Dolutegravir With No Intensification or Intensification With Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV",COMPLETED,,PHASE4,191.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,NIH,,,,,,,2021,1.0
NCT03937908,,2019-04-23,2022-03-15,,2022-04-08,2019-05-01,2019-05-06,ACTUAL,2022-04-08,2022-05-04,ACTUAL,,,,2022-04-08,2022-05-04,ACTUAL,2019-10-31,ACTUAL,2019-10-31,2022-04,2022-04-30,2020-12-21,ACTUAL,2020-12-21,2020-12-21,ACTUAL,2020-12-21,,INTERVENTIONAL,,,Pharmacokinetics Centella Asiatica Product (CAP) in Mild Cognitive Impairment,A Pharmacokinetic Study of Centella Asiatica Product (CAP) in Elderly Participants With Mild Cognitive Impairment Receiving Cholinesterase Inhibitor Therapy,TERMINATED,,EARLY_PHASE1,5.0,ACTUAL,Oregon Health and Science University,Study was discontinued before the target number of participants were enrolled due to pandemic-related restrictions.,2.0,,Participant study visits not possible during COVID-19 pandemic. Funder not able to support a continuation at some future date.,f,,,,t,t,f,,,,,,Immediately after publication and for a period of 3 years following publication.,"Anyone who wishes access to the data, for any reason. Requests should be directed to Dr. Amala Soumyanath at soumyana@ohsu.edu",,YES,ALL IPD that underlie results in a publication will be shared via a published journal article.,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,OTHER,,,,,,,2020,0.0
NCT03502616,,2018-04-11,2020-12-15,,2021-08-19,2018-04-11,2018-04-18,ACTUAL,2020-12-15,2021-01-11,ACTUAL,,,,2021-08-19,2021-09-17,ACTUAL,2018-06-07,ACTUAL,2018-06-07,2021-08,2021-08-31,2020-08-20,ACTUAL,2020-08-20,2019-12-19,ACTUAL,2019-12-19,,INTERVENTIONAL,,"Safety analysis set: included all participants who were randomized and received at least one dose of the investigational product (that is \[i.e.\], tofacitinib or placebo).",Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS),"A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)",COMPLETED,,PHASE3,270.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,INDUSTRY,,,,,,,2020,1.0
NCT06061523,,2023-09-25,,,2024-04-10,2023-09-25,2023-09-29,ACTUAL,,,,,,,2024-04-10,2024-04-12,ACTUAL,2024-07-15,ESTIMATED,2024-07-15,2024-04,2024-04-30,2024-09-09,ESTIMATED,2024-09-09,2024-09-09,ESTIMATED,2024-09-09,,INTERVENTIONAL,,,A Clinical Trial to Evaluate Bioavailability and Effect of Food for Sotorasib in Healthy Participants,"A Phase I, Open-label, Randomized Crossover Study to Evaluate the Relative Bioavailability and the Effect of Food for Sotorasib Tablets in Healthy Participants",WITHDRAWN,,PHASE1,0.0,ACTUAL,Amgen,,2.0,,FDA and EMA agreed existing data are appropriate for approval and no further BE studies are required.,f,,,,,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,INDUSTRY,,,,,,,2024,0.0
NCT04216693,,2019-12-31,,,2023-02-19,2019-12-31,2020-01-03,ACTUAL,,,,,,,2023-02-19,2023-02-22,ACTUAL,2020-06-01,ESTIMATED,2020-06-01,2022-07,2022-07-31,2023-06-01,ESTIMATED,2023-06-01,2022-12-01,ESTIMATED,2022-12-01,,INTERVENTIONAL,,,Digoxin for Patients With Non-alcoholic Steatohepatitis (NASH),"Efficacy and Safety of Digoxin in the Treatment of Adults Patients With Non-alcoholic Steatohepatitis: a Multi-center, Randomized, Placebo-controlled Trial",WITHDRAWN,,PHASE2,0.0,ACTUAL,The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School,,2.0,,Administrative decision to terminate.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,OTHER,,,,,,,2023,0.0
NCT04860518,,2021-04-22,2022-09-12,,2023-07-03,2021-04-22,2021-04-27,ACTUAL,2022-10-12,2022-10-14,ACTUAL,,,,2023-07-03,2023-07-21,ACTUAL,2021-08-23,ACTUAL,2021-08-23,2023-07,2023-07-31,2022-04-04,ACTUAL,2022-04-04,2022-04-04,ACTUAL,2022-04-04,,INTERVENTIONAL,HIBISCUS,,Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19,"A Phase II Multi-Center, Double-Blind, Randomized and Controlled Study of the Safety and Efficacy of Intravenous Recombinant Human Interferon Beta-1a in Comparison to Dexamethasone for the Treatment of Hospitalized Patients With COVID-19 Infection",TERMINATED,,PHASE2,7.0,ACTUAL,Faron Pharmaceuticals Ltd,No formal statistical hypotheses were analysed due the early termination of the study with only 5 dosed subjects.,2.0,,The decision is based on changes in the pandemic and further weakening of the recruitment that will not enable a completion of the study in any reasonable time,f,,,,t,t,f,,,,,,,,,,,2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,INDUSTRY,,,,,,,2022,0.0
NCT05579769,,2022-10-11,,,2024-07-09,2022-10-11,2022-10-14,ACTUAL,,,,,,,2024-07-09,2024-07-10,ACTUAL,2023-03-14,ACTUAL,2023-03-14,2024-07,2024-07-31,2024-05-08,ACTUAL,2024-05-08,2024-05-08,ACTUAL,2024-05-08,,INTERVENTIONAL,,,A Phase II Pediatric Study of a Graft-VS.-Host Disease (GVHD) Prophylaxis Regimen With no Calcineurin Inhibitors After Day +60 Post First Allogeneic Hematopoietic Cell Transplant for Hematological Malignancies,A Phase II Pediatric Study of a Graft-VS.-Host Disease (GVHD) Prophylaxis Regimen With no Calcineurin Inhibitors After Day +60 Post First Allogeneic Hematopoietic Cell Transplant for Hematological Malignancies,TERMINATED,,PHASE2,3.0,ACTUAL,St. Jude Children's Research Hospital,,2.0,,Principal Investigator left institution,f,,,,f,t,f,,,t,,,Data will be made available at the time of article publication.,"Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.",,YES,"Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.",2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,OTHER,,,,,,,2024,0.0
NCT04170829,,2019-11-14,,,2020-11-29,2019-11-18,2019-11-20,ACTUAL,,,,,,,2020-11-29,2020-12-01,ACTUAL,2019-12-17,ACTUAL,2019-12-17,2020-11,2020-11-30,2020-11-26,ACTUAL,2020-11-26,2020-11-26,ACTUAL,2020-11-26,,INTERVENTIONAL,,,A Clinical Trial to Determine the Safety and Immunogenicity of Healthy Candidate MERS-CoV Vaccine (MERS002),A Phase Ib Study to Determine the Safety and Immunogenicity of the Candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Vaccine ChAdOx1 MERS in Healthy Adult Middle Eastern Volunteers,COMPLETED,,PHASE1,24.0,ACTUAL,King Abdullah International Medical Research Center,,3.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,OTHER,,,,,,,2020,1.0
NCT04305249,,2020-03-05,,,2024-07-22,2020-03-10,2020-03-12,ACTUAL,,,,,,,2024-07-22,2024-07-23,ACTUAL,2020-08-15,ACTUAL,2020-08-15,2024-04,2024-04-30,2024-05-24,ACTUAL,2024-05-24,2024-04-11,ACTUAL,2024-04-11,,INTERVENTIONAL,ERASER,,Safety and Preliminary Efficacy of ATG-017 Monotherapy or Combination Therapy With Nivolumab in Advanced Solid Tumors and Hematological Malignancies,"A Phase I, Open-Label, Multi-Center Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG-017 Monotherapy or Combination Therapy With Nivolumab in Patients With Advanced Solid Tumors and Hematological Malignancies",TERMINATED,,PHASE1,36.0,ACTUAL,Antengene Corporation,,2.0,,The study was terminated based on the internal need to re-prioritization the whole pipeline and phase 1 portfolio.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,INDUSTRY,,,,,,,2024,0.0
NCT04032535,,2019-07-17,,,2023-01-23,2019-07-23,2019-07-25,ACTUAL,,,,,,,2023-01-23,2023-01-25,ACTUAL,2019-07-24,ACTUAL,2019-07-24,2023-01,2023-01-31,2022-12-05,ACTUAL,2022-12-05,2022-12-05,ACTUAL,2022-12-05,,INTERVENTIONAL,CHF6523,,"Investigate the Safety, Tolerability and Pharmacokinetics of CHF6523 in Healthy and in COPD Subjects","A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of CHF 6523 After Single or Multiple Ascending Doses in Healthy Subjects, Followed by a Placebo Controlled Repeated Dose 2-way Crossover in COPD Subjects",COMPLETED,,PHASE1,136.0,ACTUAL,Chiesi Farmaceutici S.p.A.,,3.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,INDUSTRY,,,,,,,2022,0.0
NCT03800641,,2019-01-07,,,2022-01-07,2019-01-09,2019-01-11,ACTUAL,,,,,,,2022-01-07,2022-01-11,ACTUAL,2019-01-11,ACTUAL,2019-01-11,2022-01,2022-01-31,2020-01-23,ACTUAL,2020-01-23,2019-03-29,ACTUAL,2019-03-29,,INTERVENTIONAL,,,A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation,"A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation With Administration of Oral, Intravenous and Nasal Drops",COMPLETED,,PHASE4,45.0,ACTUAL,Eye & ENT Hospital of Fudan University,,3.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,OTHER,,,,,,,2020,1.0
NCT05622058,,2022-06-01,,,2023-02-24,2022-11-16,2022-11-18,ACTUAL,,,,,,,2023-02-24,2023-02-27,ACTUAL,2023-01-09,ACTUAL,2023-01-09,2023-02,2023-02-28,2023-02-22,ACTUAL,2023-02-22,2023-02-22,ACTUAL,2023-02-22,,INTERVENTIONAL,,,A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer,"A Phase 1b Clinical Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, as a Chemoprotection Agent in Patients With TP53-Mutated, HER2 Negative Breast Cancer Receiving Neoadjuvant or Adjuvant Chemotherapy With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)",TERMINATED,,PHASE1,6.0,ACTUAL,"Aileron Therapeutics, Inc.",,1.0,,The study has been terminated early given that the first four patients enrolled have experienced Grade 4 neutropenia and alopecia after cycle 1 and as such failed to meet the primary endpoint and the main secondary endpoint.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,INDUSTRY,,,,,,,2023,0.0
NCT05504486,,2022-05-31,,,2023-01-26,2022-08-15,2022-08-17,ACTUAL,,,,,,,2023-01-26,2023-01-30,ACTUAL,2022-08-29,ESTIMATED,2022-08-29,2023-01,2023-01-31,2023-04-05,ESTIMATED,2023-04-05,2023-03-22,ESTIMATED,2023-03-22,,INTERVENTIONAL,,,Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety,"A Phase 4, Multicenter, Single-arm, Open-label, Interventional fMRI Trial to Assess the Effect of Brexpiprazole as Adjunctive Therapy on Functional Brain Network Organization in Adults With Major Depressive Disorder and Symptoms of Anxiety",WITHDRAWN,,PHASE4,0.0,ACTUAL,"Otsuka Pharmaceutical Development & Commercialization, Inc.",,1.0,,Sponsor strategic decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,INDUSTRY,,,,,,,2023,0.0
NCT04038437,,2019-07-26,,,2022-11-07,2019-07-29,2019-07-30,ACTUAL,,,,,,,2022-11-07,2022-11-09,ACTUAL,2019-10-15,ACTUAL,2019-10-15,2022-11,2022-11-30,2022-09-24,ACTUAL,2022-09-24,2022-04-26,ACTUAL,2022-04-26,,INTERVENTIONAL,,,A Trial of CPX-351 Lower Intensity Therapy (LIT) Plus Venetoclax as First Line Treatment for Subjects With AML,A Phase 1b Trial of CPX-351 Lower Intensity Therapy (LIT) Plus Venetoclax as First Line Treatment for Subjects With AML Who Are Unfit for Intensive Chemotherapy,COMPLETED,,PHASE1,35.0,ACTUAL,Jazz Pharmaceuticals,,1.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,INDUSTRY,,,,,,,2022,1.0
NCT03597282,,2018-07-13,,,2020-09-01,2018-07-13,2018-07-24,ACTUAL,,,,,,,2020-09-01,2020-09-03,ACTUAL,2018-10-08,ACTUAL,2018-10-08,2020-09,2020-09-30,2020-08-11,ACTUAL,2020-08-11,2020-05-05,ACTUAL,2020-05-05,,INTERVENTIONAL,,,A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma,"An Open-label, Phase 1B Study of NEO-PV-01 + CD40 Agonist Antibody (APX005M) or Ipilimumab With Nivolumab in Patients With Advanced or Metastatic Melanoma",TERMINATED,,PHASE1,22.0,ACTUAL,BioNTech SE,,7.0,,Closed due to historically slow enrollment compounded by the COVID-19 pandemic.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,INDUSTRY,,,,,,,2020,0.0
NCT04079413,,2019-09-03,,,2020-07-21,2019-09-03,2019-09-06,ACTUAL,,,,,,,2020-07-21,2020-07-23,ACTUAL,2019-06-03,ACTUAL,2019-06-03,2019-09,2019-09-30,2020-01-21,ACTUAL,2020-01-21,2020-01-21,ACTUAL,2020-01-21,,INTERVENTIONAL,,,Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients,"An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of GP40071 (OOO GEROPHARM, Russia) Compared to NovoRapid® Penfill® (Novo Nordisk A/S, Denmark) in Type 1 Diabetes Mellitus Patients",COMPLETED,,PHASE3,264.0,ACTUAL,Geropharm,,2.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,INDUSTRY,,,,,,,2020,1.0
NCT05564416,,2022-09-30,,,2024-03-01,2022-09-30,2022-10-03,ACTUAL,,,,,,,2024-03-01,2024-03-05,ACTUAL,2023-10-12,ESTIMATED,2023-10-12,2023-07,2023-07-31,2023-11-03,ESTIMATED,2023-11-03,2023-11-03,ESTIMATED,2023-11-03,,INTERVENTIONAL,,,"Testing Anti-Cancer Drugs Erdafitinib With or Without Atezolizumab in Patients With Localized Bladder Cancer Not Able to Receive Cisplatin Chemotherapy, NERA Trial","An Open Label, Randomized Phase II Study Neoadjuvant Erdafitinib With or Without Atezolizumab in Cisplatin-Ineligible Patients With Muscle Invasive Bladder Cancer (NERA)",WITHDRAWN,,PHASE2,0.0,ACTUAL,National Cancer Institute (NCI),,2.0,,Feasibility issues per Complete Sheet,f,,,,f,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.",2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,NIH,,,,,,,2023,0.0
NCT05735756,,2022-01-26,,,2023-02-09,2023-02-09,2023-02-21,ACTUAL,,,,,,,2023-02-09,2023-02-21,ACTUAL,2022-01-17,ACTUAL,2022-01-17,2023-02,2023-02-28,2022-04-22,ACTUAL,2022-04-22,2022-04-22,ACTUAL,2022-04-22,,INTERVENTIONAL,Ci-FCP,,Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain,Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain,TERMINATED,,PHASE4,1.0,ACTUAL,Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA),,2.0,,The clinical trial has ended prematurely due to low patient recruitment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,OTHER,,,,,,,2022,0.0
NCT05192213,,2021-06-07,,,2024-01-26,2021-12-30,2022-01-14,ACTUAL,,,,,,,2024-01-26,2024-01-30,ACTUAL,2021-08-01,ACTUAL,2021-08-01,2024-01,2024-01-31,2022-09-19,ACTUAL,2022-09-19,2022-07-14,ACTUAL,2022-07-14,,INTERVENTIONAL,,,"Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock","Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock: a Randomized Clinical Study (VITAMIN TRIAL)",TERMINATED,,PHASE3,71.0,ACTUAL,Hospital Sirio-Libanes,,2.0,,"In order to preserve the safety of the patients and prevent any harm from occurring, we opted to discontinue the study based on previous results (LOVIT study) published at 2022. Were recruited 71 than 1090 participants.",f,,,,t,f,f,,,,,,,,,NO,The study protocol and SAP are not submitted.,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,OTHER,,,,,,,2022,0.0
NCT04589260,,2020-10-08,,,2022-02-07,2020-10-14,2020-10-19,ACTUAL,,,,,,,2022-02-07,2022-02-23,ACTUAL,2020-10-15,ACTUAL,2020-10-15,2022-02,2022-02-28,2021-10-04,ACTUAL,2021-10-04,2021-05-06,ACTUAL,2021-05-06,,INTERVENTIONAL,,,TD-1058 First-In-Human Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis,"A Ph 1, Rndmzd, Dbl-Blinded, Pbo-Controlled, 4-Part Study to Eval the Safety, Tolerability, PK, and PD of TD-1058 Admin by Inhalation of Single (A) and Multiple (B) Ascending Doses in Healthy Subjs and Subjs With IPF (C) and Following Admin Microtracer Doses (D)",TERMINATED,,PHASE1,72.0,ACTUAL,Theravance Biopharma,,2.0,,The Sponsor has decided to stop the study due to business reasons. Study was terminated before initiation of part C and D (Decision to not proceed with Parts C and D was not for safety reasons and do not impact the overall risk benefit of the IMP.),f,,,,f,f,f,,,,,,,,,NO,"Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.",2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,INDUSTRY,,,,,,,2021,0.0
NCT00585195,,2007-12-29,2021-07-30,,2023-01-10,2007-12-29,2008-01-03,ESTIMATED,2021-09-17,2021-10-14,ACTUAL,,,,2023-01-10,2023-02-08,ACTUAL,2006-04-19,ACTUAL,2006-04-19,2023-01,2023-01-31,2022-01-19,ACTUAL,2022-01-19,2020-07-30,ACTUAL,2020-07-30,,INTERVENTIONAL,PROFILE 1001,Safety analysis (SA) set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.,"A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer","PHASE 1 SAFETY, PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF PF-02341066, A MET/HGFR SELECTIVE TYROSINE KINASE INHIBITOR, ADMINISTERED ORALLY TO PATIENTS WITH ADVANCED CANCER",COMPLETED,,PHASE1,596.0,ACTUAL,Pfizer,,1.0,,,f,,,,f,,,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,INDUSTRY,,,,,,,2022,1.0
NCT03847909,,2019-02-15,2024-03-27,2022-06-20,2024-05-17,2019-02-18,2019-02-20,ACTUAL,2024-05-17,2024-05-22,ACTUAL,,2024-05-22,ACTUAL,2024-05-17,2024-05-22,ACTUAL,2019-10-28,ACTUAL,2019-10-28,2024-05,2024-05-31,2021-06-29,ACTUAL,2021-06-29,2021-06-21,ACTUAL,2021-06-21,,INTERVENTIONAL,PHYOX2,,A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2,"A Phase 2 Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of DCR-PHXC Solution for Injection (Subcutaneous Use) in Patients With Primary Hyperoxaluria",COMPLETED,,PHASE2,35.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,INDUSTRY,,,,,,,2021,1.0
NCT04328636,,2020-03-29,,,2020-08-14,2020-03-29,2020-03-31,ACTUAL,,,,,,,2020-08-14,2020-08-18,ACTUAL,2017-11-01,ACTUAL,2017-11-01,2020-08,2020-08-31,2020-08-01,ACTUAL,2020-08-01,2020-07-01,ACTUAL,2020-07-01,,INTERVENTIONAL,NebMag,,Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn,Nebulized Magnesium Sulfate for Treatment of Persistent Pulmonary Hypertension of The Newborn,COMPLETED,,PHASE1/PHASE2,28.0,ACTUAL,Sohag University,,2.0,,,f,,,,,f,f,,,f,,,,,,,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,OTHER,,,,,,,2020,1.0
NCT04274803,,2020-02-15,,,2021-06-09,2020-02-15,2020-02-18,ACTUAL,,,,,,,2021-06-09,2021-06-14,ACTUAL,2020-04-01,ACTUAL,2020-04-01,2021-06,2021-06-30,2021-05-31,ESTIMATED,2021-05-31,2021-05-31,ESTIMATED,2021-05-31,,INTERVENTIONAL,,,Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?,Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?,WITHDRAWN,,PHASE4,0.0,ACTUAL,Tanta University,,2.0,,no patient enrolled,f,,,,t,f,f,,,f,,,9 months,,,YES,when approved by ethical committee,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,OTHER,,,,,,,2021,0.0
NCT03970616,,2019-05-28,,,2023-07-10,2019-05-30,2019-05-31,ACTUAL,,,,,,,2023-07-10,2023-07-12,ACTUAL,2019-09-30,ACTUAL,2019-09-30,2023-07,2023-07-31,2023-04-04,ACTUAL,2023-04-04,2023-04-04,ACTUAL,2023-04-04,,INTERVENTIONAL,DEDUCTIVE,,A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma,"A Phase 1b/2, Open-Label, Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma",TERMINATED,,PHASE1/PHASE2,27.0,ACTUAL,"AVEO Pharmaceuticals, Inc.",,1.0,,The study was terminated due to regulatory approval of newer therapeutic options and slower than anticipated accrual.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,INDUSTRY,,,,,,,2023,0.0
NCT04523090,,2020-08-20,,,2022-08-12,2020-08-20,2020-08-21,ACTUAL,,,,,,,2022-08-12,2022-08-16,ACTUAL,2020-08-27,ACTUAL,2020-08-27,2022-08,2022-08-31,2022-08-12,ACTUAL,2022-08-12,2021-12-21,ACTUAL,2021-12-21,,INTERVENTIONAL,C3-RCT,,Catalysing the Containment of COVID-19,"The C3 Nitazoxanide for Mild to Moderate COVID-19 in HIV-infected and HIV-uninfected Adults With Enhanced Risk: a Double-blind, Randomised, Placebo-controlled Trial in a Resource-poor Setting",TERMINATED,,PHASE2/PHASE3,322.0,ACTUAL,University of Cape Town,,2.0,,Signal of futility at interim analysis,f,,,,t,f,f,,,,,,,,,,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,OTHER,,,,,,,2022,0.0
NCT03865615,,2018-12-21,,,2022-06-01,2019-03-05,2019-03-07,ACTUAL,,,,,,,2022-06-01,2022-06-06,ACTUAL,2023-11-01,ESTIMATED,2023-11-01,2022-06,2022-06-30,2024-04-20,ESTIMATED,2024-04-20,2024-04-20,ESTIMATED,2024-04-20,,INTERVENTIONAL,,,Oxytocin on Approach Bias and Craving,The Effects of Intranasal Oxytocin on Approach Bias and Craving in Moderate to Heavy Alcohol Drinkers,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, San Francisco",,2.0,,COVID made study visits impossible during the funding period.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,OTHER,,,,,,,2024,0.0
NCT03729245,,2018-10-29,2023-02-17,,2023-03-17,2018-10-31,2018-11-02,ACTUAL,2023-03-17,2023-04-11,ACTUAL,,,,2023-03-17,2023-04-11,ACTUAL,2018-12-18,ACTUAL,2018-12-18,2023-03,2023-03-31,2022-10-19,ACTUAL,2022-10-19,2022-01-07,ACTUAL,2022-01-07,,INTERVENTIONAL,,"A total of 623 patients were randomized in the ITT International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) All-risk population, including 514 patients for the ITT I/P-risk population:~* NKTR-214/nivolumab: 311 and 256, respectively~* Sunitinib or cabozantinib: 312 and 258, respectively",A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC),A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined With Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients With Previously Untreated Advanced Renal Cell Carcinoma,TERMINATED,,PHASE3,623.0,ACTUAL,Nektar Therapeutics,,2.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,INDUSTRY,,,,,,,2022,0.0
NCT04627532,,2020-10-21,,,2021-01-04,2020-11-08,2020-11-13,ACTUAL,,,,,,,2021-01-04,2021-01-06,ACTUAL,2020-10-23,ACTUAL,2020-10-23,2020-12,2020-12-31,2020-12-17,ACTUAL,2020-12-17,2020-12-17,ACTUAL,2020-12-17,,INTERVENTIONAL,,,Single Ascending Dose Study of Intravenous Infusion of PF 07304814 in Healthy Adult Participants,"A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING DOSES OF PF-07304814 ADMINISTERED AS A 24-H IV INFUSION IN HEALTHY ADULT PARTICIPANTS",COMPLETED,,PHASE1,16.0,ACTUAL,Pfizer,,2.0,,,f,,,,,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,INDUSTRY,,,,,,,2020,1.0
NCT02434965,,2015-04-27,,,2021-02-19,2015-04-30,2015-05-06,ESTIMATED,,,,,,,2021-02-19,2021-02-23,ACTUAL,2019-12,ESTIMATED,2019-12-31,2019-09,2019-09-30,2022-01,ESTIMATED,2022-01-31,2021-01,ESTIMATED,2021-01-31,,INTERVENTIONAL,HPDSC+HIE,,Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy,A Safety and Feasibility Study of Autologous Cord Blood (CB) and Human Placental Derived Stem Cells (HPDSC) in Neonates With Severe Hypoxic-Ischemic Encephalopathy (HIE),WITHDRAWN,,PHASE2,0.0,ACTUAL,New York Medical College,,1.0,,Study not started,f,,,,f,t,f,,,,,,,,,NO,Study not enrolling,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,OTHER,,,,,,,2022,0.0
NCT03057977,,2017-02-16,2021-04-26,,2021-04-26,2017-02-16,2017-02-20,ACTUAL,2021-04-26,2021-05-18,ACTUAL,,,,2021-04-26,2021-05-18,ACTUAL,2017-03-06,ACTUAL,2017-03-06,2021-04,2021-04-30,2020-05-28,ACTUAL,2020-05-28,2020-05-01,ACTUAL,2020-05-01,,INTERVENTIONAL,,Randomised Set (RS): All randomised patients.,EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced),"A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)",COMPLETED,,PHASE3,3730.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,INDUSTRY,,,,,,,2020,1.0
NCT04590586,,2020-10-14,2022-05-24,,2022-06-23,2020-10-14,2020-10-19,ACTUAL,2022-06-23,2022-06-29,ACTUAL,,,,2022-06-23,2022-06-29,ACTUAL,2020-11-24,ACTUAL,2020-11-24,2022-06,2022-06-30,2021-08-03,ACTUAL,2021-08-03,2021-08-03,ACTUAL,2021-08-03,,INTERVENTIONAL,COMMUNITY,"Baseline characteristics are reported for the full analysis set, which includes all participants who were randomized to the sub-protocol candidate agent arm as well as all participants who were randomized to any placebo arm included in the control arm of the candidate agent. The Total number of participants (621) includes participants randomized to placebo and included in more than one placebo control group (106 participants); 515 unique participants were enrolled in the study.",Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients,Industry Alliance Platform Trial to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients,COMPLETED,,PHASE3,515.0,ACTUAL,Amgen,,6.0,,,f,,,,t,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,INDUSTRY,,,,,,,2021,1.0
NCT03589976,,2018-07-05,2021-11-08,,2021-11-08,2018-07-05,2018-07-18,ACTUAL,2021-11-08,2021-12-07,ACTUAL,,,,2021-11-08,2021-12-07,ACTUAL,2018-09-01,ACTUAL,2018-09-01,2021-11,2021-11-30,2021-01-01,ACTUAL,2021-01-01,2020-11-20,ACTUAL,2020-11-20,,INTERVENTIONAL,,,A Futility Trial of Sirolimus in Multiple System Atrophy,"A Single Center Randomized,Double Blind, Placebo-controlled Futility Trial to Determine if Sirolimus is of Sufficient Promise to Slow the Progression of Multiple System Atrophy",TERMINATED,,PHASE2,47.0,ACTUAL,NYU Langone Health,,2.0,,Interim analysis showed early evidence of futility of sirolimus. Trial stopped per DSMB recommendation.,f,,,,t,t,f,,,,,,Beginning 3 months and ending 5 years following article publication.,Researchers who provide a methodologically sound proposal that has been approved by a local Institutional Review Board.,,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).",2024-10-16 22:27:14.60138,2024-10-16 22:27:14.60138,OTHER,,,,,,,2021,0.0
NCT02074436,,2014-02-26,2022-05-18,,2022-06-26,2014-02-26,2014-02-28,ESTIMATED,2022-06-26,2022-07-19,ACTUAL,,,,2022-06-26,2022-07-19,ACTUAL,2014-05-23,ACTUAL,2014-05-23,2022-06,2022-06-30,2021-05-14,ACTUAL,2021-05-14,2020-11-24,ACTUAL,2020-11-24,,INTERVENTIONAL,PROBLEMA,,PRevention Of BLeeding in hEmatological Malignancies With Antifibrinolytic (Epsilon Aminocaproic Acid),Randomized Trial of Epsilon Aminocaproic Acid Versus Platelet Transfusions for the Prevention of Bleeding in Thrombocytopenic Patients With Hematological Malignancies,TERMINATED,,PHASE2,29.0,ACTUAL,Emory University,Early termination of the study because of recruitment difficulties lead to insufficient data collection and analysis of primary and secondary outcome measures.,2.0,,Slow accrual,f,,,,t,,,,,,,,,,,,,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,OTHER,,,,,,,2021,0.0
NCT04515329,,2020-08-05,,,2023-12-10,2020-08-13,2020-08-17,ACTUAL,,,,,,,2023-12-10,2023-12-18,ACTUAL,2023-12-08,ACTUAL,2023-12-08,2023-12,2023-12-31,2023-12-08,ACTUAL,2023-12-08,2023-12-08,ACTUAL,2023-12-08,,INTERVENTIONAL,,,Tear Film Markers in Dry Eye Syndrome,Tear Film Markers in Dry Eye Syndrome: Impact of Immunomodulatory Therapy,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Pittsburgh,,2.0,,No participants were enrolled. Study never started.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,OTHER,,,,,,,2023,0.0
NCT04629781,,2020-10-22,,,2024-07-31,2020-11-10,2020-11-16,ACTUAL,,,,,,,2024-07-31,2024-08-01,ACTUAL,2021-05-28,ACTUAL,2021-05-28,2024-07,2024-07-31,2024-01-29,ACTUAL,2024-01-29,2024-01-29,ACTUAL,2024-01-29,,INTERVENTIONAL,,,Open-label Dose Escalation Phase 1b Trial of a New Micellar Docetaxel Compound in Patients With mCRPC,Open-label Dose Escalation Phase 1b Trial of a New Micellar Docetaxel Compound in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC),TERMINATED,,PHASE1,11.0,ACTUAL,Swiss Group for Clinical Cancer Research,,1.0,,SAKK decided to premature terminate this trial as additional follow-up visits do not further contribute to the efficacy data. This decision does not adversely impact the patients.,f,,,,t,f,f,,,,,,,,,,,2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,OTHER,,,,,,,2024,0.0
NCT03357133,,2017-11-23,,,2020-09-06,2017-11-23,2017-11-29,ACTUAL,,,,,,,2020-09-06,2020-09-09,ACTUAL,2017-12-16,ACTUAL,2017-12-16,2020-09,2020-09-30,2020-08-31,ACTUAL,2020-08-31,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,MR TEA,,Tirofiban for Patients Treated With Alteplase,"A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Early Administration of Tirofiban in Acute Ischemic Stroke Patients Treated With Intravenous Alteplase Thrombolysis",TERMINATED,,PHASE2/PHASE3,30.0,ACTUAL,Capital Medical University,,2.0,,The number and speed of enrollment were significantly less than expected.,f,,,,,f,f,,,,,,,,,,,2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,OTHER,,,,,,,2020,0.0
NCT04080908,,2019-09-04,2023-06-29,,2023-06-29,2019-09-04,2019-09-06,ACTUAL,2023-06-29,2023-07-18,ACTUAL,,,,2023-06-29,2023-07-18,ACTUAL,2020-01-15,ACTUAL,2020-01-15,2023-06,2023-06-30,2021-10-19,ACTUAL,2021-10-19,2021-10-19,ACTUAL,2021-10-19,,INTERVENTIONAL,AMAGFeraheme,,Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support,Open Label Single Arm Pilot Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support,TERMINATED,,PHASE4,1.0,ACTUAL,NYU Langone Health,,1.0,,Unable to meet enrollment goals.,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,OTHER,,,,,,,2021,0.0
NCT03338621,,2017-11-03,2023-09-08,,2024-03-05,2017-11-08,2017-11-09,ACTUAL,2023-10-16,2023-11-08,ACTUAL,,,,2024-03-05,2024-03-07,ACTUAL,2018-07-30,ACTUAL,2018-07-30,2024-03,2024-03-31,2022-06-10,ACTUAL,2022-06-10,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,,,"Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients","An Open-Label, Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of a 4-month Treatment of Bedaquiline Plus Pretomanid Plus Moxifloxacin Plus Pyrazinamide (BPaMZ) Compared to a 6-month Treatment of HRZE/HR (Control) in Adult Participants With Drug-Sensitive Smear-Positive Pulmonary Tuberculosis (DS-TB) and a 6-month Treatment of BPaMZ in Adult Participants With Drug Resistant, Smear-Positive Pulmonary Tuberculosis (DR-TB)",COMPLETED,,PHASE2/PHASE3,455.0,ACTUAL,Global Alliance for TB Drug Development,,3.0,,,f,,,,t,t,f,,,,,,Data is expected to become available in mid-2024.,Researchers must agree to the Terms and Conditions for Use of the TB-PACTS data platform and submit an online application form to request access to the data platform.,https://c-path.org/tools-platforms/tb-pacts/,YES,"IPD from the trial will be submitted to Critical Path Institute which will make fully anonymized data available through the Tuberculosis Platform for Aggregation of Clinical TB Studies (TB-PACTS) database. Data sets for Drug susceptibility data, Demographic data, MTB diagnostic testing results, Concomitant medications information, Adverse event information, Treatment adherence information, Co-morbidities, Treatment outcomes, HIV co-infection information, CD4 counts, TB disease symptoms from all collected IPD will be made available.",2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,OTHER,,,,,,,2022,1.0
NCT03946800,,2019-05-06,,,2024-09-30,2019-05-10,2019-05-13,ACTUAL,,,,,,,2024-09-30,2024-10-02,ACTUAL,2019-05-08,ACTUAL,2019-05-08,2024-09,2024-09-30,2023-08-24,ACTUAL,2023-08-24,2023-08-24,ACTUAL,2023-08-24,,INTERVENTIONAL,,,A Study of MEDI1191 in Sequential and Concurrent Combination With Durvalumab in Subjects With Advanced Solid Tumors,"A Phase 1, Open-label, Dose-escalation and Expansion Study of MEDI1191 Administered Intratumorally as Monotherapy and in Combination With Durvalumab in Subjects With Advanced Solid Tumors",COMPLETED,,PHASE1,61.0,ACTUAL,MedImmune LLC,,2.0,,,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,INDUSTRY,,,,,,,2023,1.0
NCT03556020,,2018-06-01,,2022-08-18,2022-08-18,2018-06-01,2018-06-14,ACTUAL,,,,2022-08-18,2022-08-23,ACTUAL,2022-08-18,2022-08-23,ACTUAL,2018-07-15,ACTUAL,2018-07-15,2022-08,2022-08-31,2022-01-07,ACTUAL,2022-01-07,2022-01-07,ACTUAL,2022-01-07,,INTERVENTIONAL,VIP,,"Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAH","A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous (SC) Injections of a Sustained-Release Vasoactive Intestinal Peptide (VIP) Analogue, Pemziviptadil (PB1046), in Adult Subjects With Symptomatic Pulmonary Arterial Hypertension (PAH)",TERMINATED,,PHASE2,35.0,ACTUAL,PhaseBio Pharmaceuticals Inc.,,2.0,,Terminated: Study drug resupply delayed (Covid-19),f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,INDUSTRY,,,,,,,2022,0.0
NCT05764915,,2023-01-11,,,2024-07-30,2023-02-28,2023-03-13,ACTUAL,,,,,,,2024-07-30,2024-08-01,ACTUAL,2023-02-15,ACTUAL,2023-02-15,2024-07,2024-07-31,2024-02-20,ACTUAL,2024-02-20,2024-02-20,ACTUAL,2024-02-20,,INTERVENTIONAL,,,A Phase I Study of RGT-264 in Subjects With Advanced Solid Tumors,"A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of RGT-264 Phosphate Tablets in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,11.0,ACTUAL,Regor Pharmaceuticals Inc.,,1.0,,Due to the change in study plan and not due to safety reasons,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,INDUSTRY,,,,,,,2024,0.0
NCT04713592,,2021-01-13,2024-03-18,,2024-06-13,2021-01-14,2021-01-19,ACTUAL,2024-06-13,2024-06-14,ACTUAL,,,,2024-06-13,2024-06-14,ACTUAL,2021-02-26,ACTUAL,2021-02-26,2024-06,2024-06-30,2023-04-20,ACTUAL,2023-04-20,2023-04-20,ACTUAL,2023-04-20,,INTERVENTIONAL,IMMprint,"Intent to Treat Population: all randomized participants, analyzed according to the treatment groups to which they were randomized during the Double-blind Period",Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement,"IMMprint: A Phase 3b Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Safety and Efficacy of Risankizumab Compared to Placebo in Adult Subjects With Moderate to Severe Plaque Psoriasis With Palmoplantar (Non-Pustular) Involvement (PPPsO)",COMPLETED,,PHASE3,174.0,ACTUAL,AbbVie,,2.0,,,f,,,,f,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,INDUSTRY,,,,,,,2023,1.0
NCT03429543,,2018-02-06,2023-11-28,2023-10-18,2024-02-22,2018-02-06,2018-02-12,ACTUAL,2024-02-22,2024-02-23,ACTUAL,,2024-02-23,ACTUAL,2024-02-22,2024-02-23,ACTUAL,2018-03-20,ACTUAL,2018-03-20,2024-02,2024-02-29,2023-05-31,ACTUAL,2023-05-31,2022-10-19,ACTUAL,2022-10-19,,INTERVENTIONAL,,"The randomised set (RS) included all randomised patients, regardless whether they took trial medication",Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM,"A Double-blind, Randomised, Placebo-controlled, Parallel Group Trial to Evaluate the Efficacy and Safety of Empagliflozin and Linagliptin Over 26 Weeks, With a Double-blind Active Treatment Safety Extension Period up to 52 Weeks, in Children and Adolescents With Type 2 Diabetes Mellitus",COMPLETED,,PHASE3,175.0,ACTUAL,Boehringer Ingelheim,,7.0,,,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,INDUSTRY,,,,,,,2023,1.0
NCT02937454,,2016-10-14,2021-04-23,,2021-05-25,2016-10-14,2016-10-18,ESTIMATED,2021-05-25,2021-06-18,ACTUAL,,,,2021-05-25,2021-06-18,ACTUAL,2017-04-03,ACTUAL,2017-04-03,2021-05,2021-05-31,2020-07-21,ACTUAL,2020-07-21,2020-07-21,ACTUAL,2020-07-21,,INTERVENTIONAL,Affirm-AHF,,Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency,"A Randomised, Double-Blind Placebo Controlled Trial Comparing the Effect of Intravenous Ferric Carboxymaltose on Hospitalisations and Mortality in Iron Deficient Patients Admitted for Acute Heart Failure (Affirm-AHF)",COMPLETED,,PHASE4,1132.0,ACTUAL,Vifor Pharma,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,INDUSTRY,,,,,,,2020,1.0
NCT04064346,,2019-08-19,2022-12-12,,2023-01-10,2019-08-19,2019-08-21,ACTUAL,2023-01-10,2023-02-06,ACTUAL,,,,2023-01-10,2023-02-06,ACTUAL,2021-10-28,ACTUAL,2021-10-28,2023-01,2023-01-31,2022-08-03,ACTUAL,2022-08-03,2022-08-03,ACTUAL,2022-08-03,,INTERVENTIONAL,ACTION,,Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease,"A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants With Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-label Phase: The ACTION Study",TERMINATED,,PHASE3,12.0,ACTUAL,Palladio Biosciences,,2.0,,The decision is based on a thorough reassessment of the commercial potential of lixivaptan as a potential best-in-class therapy for patients with autosomal dominant polycystic kidney disease (ADPKD).,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,INDUSTRY,,,,,,,2022,0.0
NCT03333148,,2017-10-20,,,2020-08-13,2017-11-01,2017-11-06,ACTUAL,,,,,,,2020-08-13,2020-08-17,ACTUAL,2020-06-01,ESTIMATED,2020-06-01,2020-08,2020-08-31,2022-01-01,ESTIMATED,2022-01-01,2021-06-01,ESTIMATED,2021-06-01,,INTERVENTIONAL,PINT,,Preoperative Oral ImmunoNuTrition to Improve Surgical Outcomes for IBD Patients (PINT),Preoperative Oral ImmunoNuTrition to Improve Surgical Outcomes for Inflammatory Bowel Disease Patients (PINT): A Randomized Controlled Trial,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Alabama at Birmingham,,2.0,,never enrolled,f,,,,f,t,f,,,,,,,,,,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,OTHER,,,,,,,2022,0.0
NCT02989129,,2016-12-08,,,2018-04-16,2016-12-08,2016-12-12,ESTIMATED,,,,,,,2018-04-16,2018-04-18,ACTUAL,2018-04,ESTIMATED,2018-04-30,2018-04,2018-04-30,2020-04,ESTIMATED,2020-04-30,2020-04,ESTIMATED,2020-04-30,,INTERVENTIONAL,,,Trial of Quercetin in the Treatment and Prevention of Chemotherapy-induced Neuropathic Pain in Cancer Patients,Prospective Open Labeled Pilot Trial of Quercetin in the Treatment and Prevention of Chemotherapy-induced Neuropathic Pain in Cancer Patients,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,FDA IND Approval,f,,,,f,t,f,,,,,,,,,,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,OTHER,,,,,,,2020,0.0
NCT03945019,,2019-05-08,2023-08-09,,2023-09-26,2019-05-08,2019-05-10,ACTUAL,2023-09-26,2023-10-23,ACTUAL,,,,2023-09-26,2023-10-23,ACTUAL,2019-10-28,ACTUAL,2019-10-28,2023-09,2023-09-30,2023-08-22,ACTUAL,2023-08-22,2022-08-23,ACTUAL,2022-08-23,,INTERVENTIONAL,,All-randomized population,CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD),"A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease",COMPLETED,,PHASE3,396.0,ACTUAL,Celltrion,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,INDUSTRY,,,,,,,2023,1.0
NCT02815995,,2016-06-16,,,2024-06-19,2016-06-27,2016-06-28,ESTIMATED,,,,,,,2024-06-19,2024-06-21,ACTUAL,2016-08-16,ACTUAL,2016-08-16,2024-06,2024-06-30,2024-06-17,ACTUAL,2024-06-17,2024-06-17,ACTUAL,2024-06-17,,INTERVENTIONAL,,,Multi-Arm Study to Test the Efficacy of Immunotherapeutic Agents in Multiple Sarcoma Subtypes,A Phase II Multi-Arm Study to Test the Efficacy of Immunotherapeutic Agents in Multiple Sarcoma Subtypes,COMPLETED,,PHASE2,56.0,ACTUAL,M.D. Anderson Cancer Center,,6.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,OTHER,,,,,,,2024,1.0
NCT04123574,,2019-04-30,,,2022-02-08,2019-10-09,2019-10-11,ACTUAL,,,,,,,2022-02-08,2022-02-24,ACTUAL,2019-10-15,ESTIMATED,2019-10-15,2022-02,2022-02-28,2021-12-06,ESTIMATED,2021-12-06,2021-12-06,ESTIMATED,2021-12-06,,INTERVENTIONAL,,,A Pilot Study of BXCL701 in Patients With Pancreatic Cancer,"A Pilot Proof of Mechanism Study of BXCL701, a Small Molecule Inhibitor of Dipeptidyl Peptidases (DPPs), in Patients With Pancreatic Cancer",WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,BioXcel Therapeutics Inc,,1.0,,No longer relevant to field,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,INDUSTRY,,,,,,,2021,0.0
NCT04436458,,2020-06-16,,,2022-02-04,2020-06-17,2020-06-18,ACTUAL,,,,,,,2022-02-04,2022-02-21,ACTUAL,2022-01-20,ACTUAL,2022-01-20,2021-02,2021-02-28,2022-01-20,ACTUAL,2022-01-20,2022-01-20,ACTUAL,2022-01-20,,INTERVENTIONAL,,,Niclosamide In Moderate COVID-19,"Phase 2, Multicentre, Randomized, Double Blind, 2 Arms Placebo-controlled Study in Adults With Moderate COVID-19 With Gastrointestinal Signs and Symptoms",WITHDRAWN,,PHASE2,0.0,ACTUAL,Entero Therapeutics,,2.0,,Sponsor asset acquired by another pharma company who opened their own IND for this compound. First Wave Bio never started this study in the US or ex-US.,f,,,,,f,f,,,f,,,,,,,,2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,INDUSTRY,,,,,,,2022,0.0
NCT04392128,,2020-05-15,,,2020-09-02,2020-05-15,2020-05-18,ACTUAL,,,,,,,2020-09-02,2020-09-04,ACTUAL,2020-09-02,ACTUAL,2020-09-02,2020-09,2020-09-30,2020-09-02,ACTUAL,2020-09-02,2020-09-02,ACTUAL,2020-09-02,,INTERVENTIONAL,HYACINTHE,,Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE),"Randomised, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies",WITHDRAWN,,PHASE2,0.0,ACTUAL,Institut de cancérologie Strasbourg Europe,,2.0,,competent authority decision,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,OTHER,,,,,,,2020,0.0
NCT04018313,,2019-07-09,2022-06-30,,2022-06-30,2019-07-10,2019-07-12,ACTUAL,2022-06-30,2023-05-11,ACTUAL,,,,2022-06-30,2023-05-11,ACTUAL,2020-05-28,ACTUAL,2020-05-28,2021-09,2021-09-30,2021-04-30,ACTUAL,2021-04-30,2021-03-27,ACTUAL,2021-03-27,,INTERVENTIONAL,,"ITT set: all subjects enrolled and randomly assigned to receive a dose of any study drug, regardless of whether or not any study drug was administered.","To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects","A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects",COMPLETED,,PHASE1,176.0,ACTUAL,Celltrion,,5.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,INDUSTRY,,,,,,,2021,1.0
NCT03908827,,2019-04-07,,,2020-05-04,2019-04-08,2019-04-09,ACTUAL,,,,,,,2020-05-04,2020-05-06,ACTUAL,2019-12,ESTIMATED,2019-12-31,2020-05,2020-05-31,2023-03,ESTIMATED,2023-03-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,BMAC in Severe Hip or Knee Osteoarthritis Awaiting Arthroplasty,The Effectiveness of Bone Marrow Aspirate Concentrate (BMAC) in Patients With Severe Hip or Knee Osteoarthritis Awaiting Arthroplasty - A Randomized Controlled Trial,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,CAPRI Clinic,,2.0,,Change of study design,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 00:58:15.380577,2024-10-15 00:58:15.380577,NETWORK,,,,,,,2023,0.0
NCT03360006,,2017-11-28,,,2021-03-22,2017-11-28,2017-12-02,ACTUAL,,,,,,,2021-03-22,2021-03-24,ACTUAL,2018-03-16,ACTUAL,2018-03-16,2021-03,2021-03-31,2020-12-19,ACTUAL,2020-12-19,2020-12-19,ACTUAL,2020-12-19,,INTERVENTIONAL,,,A Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Participants With Relapsed/Refractory Acute Myeloid Leukemia (AML) Cancer,A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML),TERMINATED,,PHASE1,30.0,ACTUAL,AbbVie,,2.0,,Strategic Reasons,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,INDUSTRY,,,,,,,2020,0.0
NCT04466826,,2020-07-06,,,2021-02-05,2020-07-06,2020-07-10,ACTUAL,,,,,,,2021-02-05,2021-02-10,ACTUAL,2021-01-02,ACTUAL,2021-01-02,2021-02,2021-02-28,2021-02-05,ACTUAL,2021-02-05,2021-02-05,ACTUAL,2021-02-05,,INTERVENTIONAL,,,Transnasal Sphenopalatine Ganglia Block for Management of Chronic Migraines in Pediatric Patients,Transnasal Sphenopalatine Ganglia Block for Management of Chronic Migraines in Pediatric Patients,WITHDRAWN,,PHASE2,0.0,ACTUAL,Washington University School of Medicine,,1.0,,Low enrollment,f,,,,f,t,t,,,t,,,,,,,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,OTHER,,,,,,,2021,0.0
NCT03635489,,2018-08-14,2022-05-26,,2024-06-20,2018-08-14,2018-08-17,ACTUAL,2022-05-26,2023-03-17,ACTUAL,,,,2024-06-20,2024-10-03,ACTUAL,2018-08-15,ACTUAL,2018-08-15,2024-06,2024-06-30,2023-05-11,ACTUAL,2023-05-11,2021-05-26,ACTUAL,2021-05-26,,INTERVENTIONAL,,,"A Study of the Efficacy and Safety of Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin Paclitaxel Plus Concurrent and Extended Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated, Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer",COMPLETED,,PHASE3,100.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,INDUSTRY,,,,,,,2023,1.0
NCT05204160,,2022-01-11,,,2024-07-02,2022-01-11,2022-01-24,ACTUAL,,,,,,,2024-07-02,2024-07-03,ACTUAL,2022-04-11,ACTUAL,2022-04-11,2024-07,2024-07-31,2024-02-27,ACTUAL,2024-02-27,2024-02-27,ACTUAL,2024-02-27,,INTERVENTIONAL,,,Pembrolizumab as Salvage Therapy for the Treatment of Multiple Myeloma in Patients Progressing on CAR-T Cell Therapy,Phase II Study of Pembrolizumab as Salvage Therapy Among Multiple Myeloma Patients Progressing on CAR-T Cell Therapy,WITHDRAWN,,PHASE2,0.0,ACTUAL,Emory University,,1.0,,slow accrual,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,OTHER,,,,,,,2024,0.0
NCT03286114,,2017-09-08,,,2022-11-01,2017-09-15,2017-09-18,ACTUAL,,,,,,,2022-11-01,2022-11-04,ACTUAL,2017-12-21,ACTUAL,2017-12-21,2022-11,2022-11-30,2021-04-28,ACTUAL,2021-04-28,2020-10-22,ACTUAL,2020-10-22,,INTERVENTIONAL,,,Augmentation of the Graft vs. Leukemia Effect Via Checkpoint Blockade With Pembrolizumab,Augmentation of the Graft vs. Leukemia Effect Via Checkpoint Blockade With Pembrolizumab for Relapse of Primary Malignancy After Allogeneic Hematopoietic Stem Cell Transplant: A Feasibility Study,TERMINATED,,PHASE1,16.0,ACTUAL,University of Michigan Rogel Cancer Center,,1.0,,Lack of patient population,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,OTHER,,,,,,,2021,0.0
NCT02923739,,2016-09-30,2023-08-17,,2024-03-12,2016-09-30,2016-10-05,ESTIMATED,2023-10-09,2023-10-10,ACTUAL,,,,2024-03-12,2024-03-13,ACTUAL,2017-05-05,ACTUAL,2017-05-05,2024-03,2024-03-31,2022-09-27,ACTUAL,2022-09-27,2022-09-27,ACTUAL,2022-09-27,,INTERVENTIONAL,,The study was terminated early by the sponsor,"Paclitaxel and Bevacizumab With or Without Emactuzumab in Treating Patients With Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","A Randomized Phase II Induction Discontinuation Trial of Emactuzumab Following Paclitaxel and Bevacizumab in Patients With Platinum-Resistant, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer",TERMINATED,,PHASE2,9.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,The study was terminated early by the Sponsor,f,,,,t,t,f,,,,,,,,,,,2024-10-15 14:48:42.765064,2024-10-15 14:48:42.765064,OTHER,,,,,,,2022,0.0
NCT03213457,,2017-07-07,2021-03-24,,2023-12-15,2017-07-07,2017-07-11,ACTUAL,2021-03-24,2021-04-20,ACTUAL,,,,2023-12-15,2023-12-20,ACTUAL,2017-07-07,ACTUAL,2017-07-07,2023-12,2023-12-31,2023-12-06,ACTUAL,2023-12-06,2020-03-27,ACTUAL,2020-03-27,,INTERVENTIONAL,,Full Analysis Set: all randomized participants who received at least 1 dose of study drug.,A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain,A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Estradiol/Norethindrone Acetate in Subjects With Moderate to Severe Endometriosis-Associated Pain,COMPLETED,,PHASE3,681.0,ACTUAL,AbbVie,,3.0,,,f,,,,f,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,INDUSTRY,,,,,,,2023,1.0
NCT02529475,,2015-08-18,,,2020-11-16,2015-08-19,2015-08-20,ESTIMATED,,,,,,,2020-11-16,2020-11-18,ACTUAL,2016-02-01,ACTUAL,2016-02-01,2020-11,2020-11-30,2020-09,ACTUAL,2020-09-30,2020-09,ACTUAL,2020-09-30,,INTERVENTIONAL,HYDROPS,,Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS),Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS),TERMINATED,,PHASE4,25.0,ACTUAL,"University Hospital, Grenoble",,1.0,,recruitment problem-covid-,f,,,,t,,,,,,,,,,,,,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,OTHER,,,,,,,2020,0.0
NCT04459286,,2020-07-03,,,2022-02-14,2020-07-03,2020-07-07,ACTUAL,,,,,,,2022-02-14,2022-03-02,ACTUAL,2020-10-09,ACTUAL,2020-10-09,2022-02,2022-02-28,2021-05-02,ACTUAL,2021-05-02,2021-05-02,ACTUAL,2021-05-02,,INTERVENTIONAL,NACOVID,,The Nitazoxanide Plus Atazanavir for COVID-19 Study,"A Randomized, Open Label Trial to Investigate the Efficacy and Safety of Nitazoxanide Plus Atazanavir/Ritonavir for the Treatment of COVID-19: a Pilot Study",TERMINATED,,PHASE2,57.0,ACTUAL,Obafemi Awolowo University,,2.0,,IDSMB recommendation,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,OTHER,,,,,,,2021,0.0
NCT04566926,,2020-09-24,,,2022-04-27,2020-09-24,2020-09-28,ACTUAL,,,,,,,2022-04-27,2022-04-28,ACTUAL,2020-09-29,ACTUAL,2020-09-29,2022-04,2022-04-30,2021-04-05,ACTUAL,2021-04-05,2021-04-05,ACTUAL,2021-04-05,,INTERVENTIONAL,AMPAR,,A Study of JNJ-64140284 in Healthy Male Participants,"A 3-Part, Randomized, Placebo-controlled, Double-blind, Single Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64140284 in Healthy Male Participants",TERMINATED,,PHASE1,33.0,ACTUAL,"Janssen Pharmaceutica N.V., Belgium",,4.0,,business decision,f,,,,f,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,INDUSTRY,,,,,,,2021,0.0
NCT03377309,,2017-12-14,,,2021-08-27,2017-12-18,2017-12-19,ACTUAL,,,,,,,2021-08-27,2021-09-01,ACTUAL,2019-12-01,ACTUAL,2019-12-01,2021-08,2021-08-31,2021-07-01,ACTUAL,2021-07-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,,,Safety and Tolerability of Perampanel in Amyotrophic Lateral Sclerosis Patients,Safety and Tolerability of Perampanel in Amyotrophic Lateral Sclerosis Patients,TERMINATED,,PHASE2,6.0,ACTUAL,American University of Beirut Medical Center,,1.0,,Study halted due to adverse events,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,OTHER,,,,,,,2021,0.0
NCT02322814,,2014-12-19,2019-08-09,,2023-03-16,2014-12-19,2014-12-23,ESTIMATED,2019-10-24,2019-11-13,ACTUAL,,,,2023-03-16,2023-04-13,ACTUAL,2015-03-12,ACTUAL,2015-03-12,2023-03,2023-03-31,2021-09-17,ACTUAL,2021-09-17,2018-08-10,ACTUAL,2018-08-10,,INTERVENTIONAL,,"The intent-to-treat (ITT) population was defined as all enrolled participants, whether or not the assigned study treatment was received.","A Study of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as Initial Treatment for Participants With Triple-Negative Breast Cancer That Has Spread","A Multistage, Phase II Study Evaluating the Safety and Efficacy of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as First-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer",TERMINATED,,PHASE2,169.0,ACTUAL,Hoffmann-La Roche,,4.0,,Sponsor's decision,f,,,,,,,,,,,,,,,,,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,INDUSTRY,,,,,,,2021,0.0
NCT03202095,,2017-06-26,,,2024-06-10,2017-06-26,2017-06-28,ACTUAL,,,,,,,2024-06-10,2024-06-11,ACTUAL,2017-08-01,ACTUAL,2017-08-01,2024-06,2024-06-30,2024-06-10,ACTUAL,2024-06-10,2024-06-10,ACTUAL,2024-06-10,,INTERVENTIONAL,,,Creatine for Treatment of Depression Associated With Type 2 Diabetes,Creatine for Treatment of Depression Associated With Type 2 Diabetes,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Utah,,1.0,,No referral from diabetes clinic.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,OTHER,,,,,,,2024,0.0
NCT05099159,,2021-10-19,,2024-05-28,2024-05-28,2021-10-19,2021-10-29,ACTUAL,,,,,2024-05-29,ACTUAL,2024-05-28,2024-05-29,ACTUAL,2021-10-29,ACTUAL,2021-10-29,2024-05,2024-05-31,2023-10-10,ACTUAL,2023-10-10,2023-06-13,ACTUAL,2023-06-13,,INTERVENTIONAL,,,A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2),"A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 26 Weeks in Postmenopausal Women",COMPLETED,,PHASE3,400.0,ACTUAL,Bayer,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,INDUSTRY,,,,,,,2023,1.0
NCT03743064,,2018-11-14,2024-04-18,2023-04-03,2024-06-05,2018-11-14,2018-11-15,ACTUAL,2024-06-05,2024-06-26,ACTUAL,,2024-06-26,ACTUAL,2024-06-05,2024-06-26,ACTUAL,2019-05-06,ACTUAL,2019-05-06,2024-06,2024-06-30,2022-12-27,ACTUAL,2022-12-27,2022-12-27,ACTUAL,2022-12-27,,INTERVENTIONAL,,The Intent-to-Treat (ITT) Set included all randomized patients and was analyzed as per planned treatment.,A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC),"A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)",COMPLETED,,PHASE3,318.0,ACTUAL,Helsinn Healthcare SA,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,INDUSTRY,,,,,,,2022,1.0
NCT05212701,,2021-12-29,,,2024-04-29,2022-01-14,2022-01-28,ACTUAL,,,,,,,2024-04-29,2024-04-30,ACTUAL,2022-04-19,ACTUAL,2022-04-19,2024-04,2024-04-30,2024-07,ESTIMATED,2024-07-31,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,To Assess Efficacy and Safety of Oral Reparixin in Patients With Fatigue and Locally Advanced / Metastatic Breast Cancer,"A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Assess Efficacy and Safety of Reparixin in Cancer Related Fatigue in Pts With Advanced / Metastatic Breast Cancer Undergoing Taxane-based Chemotherapy.",WITHDRAWN,,PHASE2,0.0,ACTUAL,Dompé Farmaceutici S.p.A,,2.0,,"Dompé decided to withdraw the study due to the numerous difficulties encountered in enrollment, mainly due to the rapidly and continuously changing oncology drug scenario . No patients were enrolled.",f,,,,t,t,f,,,,,,,,,,,2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,INDUSTRY,,,,,,,2024,0.0
NCT03809429,,2019-01-07,2023-02-15,,2023-12-01,2019-01-17,2019-01-18,ACTUAL,2023-12-01,2024-05-13,ACTUAL,,,,2023-12-01,2024-05-13,ACTUAL,2019-04-29,ACTUAL,2019-04-29,2022-09,2022-09-30,2022-02-16,ACTUAL,2022-02-16,2022-02-16,ACTUAL,2022-02-16,,INTERVENTIONAL,BEYOND,,Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND),"A Randomised, Controlled, Open Label, Parallel Group, Multicentre Trial Comparing the Efficacy and Safety of Individualised FE 999049 (Follitropin Delta) Dosing, Using a Long GnRH Agonist Protocol and a GnRH Antagonist Protocol in Women Undergoing Controlled Ovarian Stimulation",COMPLETED,,PHASE3,437.0,ACTUAL,Ferring Pharmaceuticals,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,INDUSTRY,,,,,,,2022,1.0
NCT04196010,,2019-12-10,,,2023-12-19,2019-12-10,2019-12-12,ACTUAL,,,,,,,2023-12-19,2023-12-28,ACTUAL,2020-05-08,ACTUAL,2020-05-08,2022-01,2022-01-31,2021-10-13,ACTUAL,2021-10-13,2021-10-13,ACTUAL,2021-10-13,,INTERVENTIONAL,,,Continuous Infusion Chemotherapy (CI-CLAM) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms,"Dose-Finding (Phase 1) Study of Continuous Infusion Cladribine, Cytarabine and Mitoxantrone (CI-CLAM) for Adults With Relapsed/Refractory Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms Treated at UW/SCCA",TERMINATED,,PHASE1,13.0,ACTUAL,University of Washington,,1.0,,Terminated due to unfavorable risk-benefit ratio of investigational regimen.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,OTHER,,,,,,,2021,0.0
NCT03445780,,2018-02-13,,,2020-01-22,2018-02-22,2018-02-26,ACTUAL,,,,,,,2020-01-22,2020-01-27,ACTUAL,2019-06,ESTIMATED,2019-06-30,2020-01,2020-01-31,2020-04,ESTIMATED,2020-04-30,2020-04,ESTIMATED,2020-04-30,,INTERVENTIONAL,,,Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection,Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection,WITHDRAWN,,PHASE1,0.0,ACTUAL,NYU Langone Health,,4.0,,No patients were enrolled; Senior author (Dr. Melamed) departed institution,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,OTHER,,,,,,,2020,0.0
NCT02860494,,2016-08-04,,,2021-04-28,2016-08-04,2016-08-09,ESTIMATED,,,,,,,2021-04-28,2021-05-03,ACTUAL,2020-12,ESTIMATED,2020-12-31,2021-04,2021-04-30,2024-12,ESTIMATED,2024-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,EVEROST,,Topical Everolimus in Patients With Tuberous Sclerosis Complex,"Topical Everolimus Versus Placebo for the Treatment of Facial Angiofibromas in Patients With Tuberous Sclerosis Complex. A Phase II/III, Multicentre, Randomized, Double-blind, Placebo-controlled Study of 3 Doses of Topical Everolimus.",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Hospices Civils de Lyon,,4.0,,Pharmaceutical and financial difficulties,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,OTHER,,,,,,,2024,0.0
NCT03991104,,2019-06-15,,,2023-09-17,2019-06-18,2019-06-19,ACTUAL,,,,,,,2023-09-17,2023-09-21,ACTUAL,2019-05-01,ACTUAL,2019-05-01,2023-09,2023-09-30,2023-12-31,ESTIMATED,2023-12-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,SOX-based CRT for Esophageal Cancer.,A Phase I/II Study of S-1 and Oxaliplatin Based Definitive Concurrent Chemoradiotherapy (SOX-CRT-01) for Unresectable Locally Advanced Esophageal Cancer.,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Zhejiang Provincial People's Hospital,,1.0,,No eligible patients enrolled. We have to withdraw the trial.,f,,,,,f,f,,,,,,,,,,,2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,OTHER,,,,,,,2023,0.0
NCT03082014,,2017-03-08,,,2023-03-07,2017-03-16,2017-03-17,ACTUAL,,,,,,,2023-03-07,2023-03-09,ACTUAL,2018-02-22,ACTUAL,2018-02-22,2023-03,2023-03-31,2022-07-28,ACTUAL,2022-07-28,2022-07-28,ACTUAL,2022-07-28,,INTERVENTIONAL,TREAT-SVDs,,Effects of Amlodipine and Other Blood Pressure Lowering Agents on Microvascular Function,EffecTs of Amlodipine and Other Blood PREssure Lowering Agents on Microvascular FuncTion in Small Vessel Diseases,TERMINATED,,PHASE3,101.0,ACTUAL,Ludwig-Maximilians - University of Munich,,3.0,,"completed for the primary study group of sporadic SVD patients, halted prematurely for the additional study group due to slow recruitment at 26 of 30 CADASIL patients in December 2022",f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,OTHER,,,,,,,2022,0.0
NCT04300309,,2020-02-18,2024-06-25,,2024-06-25,2020-03-05,2020-03-09,ACTUAL,2024-06-25,2024-10-03,ACTUAL,,,,2024-06-25,2024-10-03,ACTUAL,2020-12-21,ACTUAL,2020-12-21,2024-06,2024-06-30,2024-05-10,ACTUAL,2024-05-10,2023-07-02,ACTUAL,2023-07-02,,INTERVENTIONAL,CALINA,,"Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria","Multicenter, Open-label, Single-arm Study to Evaluate the PK, Safety, Tolerability and Efficacy of a New Artemether:Lumefantrine (2.5 mg:30 mg) Dispersible Tablet in the Treatment of Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria",TERMINATED,,PHASE2/PHASE3,28.0,ACTUAL,Novartis,,1.0,,Sponsor decision,f,,,,t,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,INDUSTRY,,,,,,,2024,0.0
NCT02043678,,2014-01-21,2019-02-12,,2024-02-20,2014-01-21,2014-01-23,ESTIMATED,2019-02-12,2019-03-05,ACTUAL,,,,2024-02-20,2024-02-26,ACTUAL,2014-03-30,ACTUAL,2014-03-30,2024-02,2024-02-29,2024-02-08,ACTUAL,2024-02-08,2018-02-15,ACTUAL,2018-02-15,,INTERVENTIONAL,ERA 223,Intent-to-treat analysis set (ITT) included all randomized participants.,"Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms","A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer(CRPC)",COMPLETED,,PHASE3,806.0,ACTUAL,Bayer,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-16 01:14:57.46866,2024-10-16 01:14:57.46866,INDUSTRY,,,,,,,2024,1.0
NCT03840343,,2019-02-11,,,2023-04-03,2019-02-11,2019-02-15,ACTUAL,,,,,,,2023-04-03,2023-04-05,ACTUAL,2019-10-23,ACTUAL,2019-10-23,2023-04,2023-04-30,2020-08-04,ACTUAL,2020-08-04,2020-08-04,ACTUAL,2020-08-04,,INTERVENTIONAL,,,Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease,Intra-arterially Delivered Autologous Mesenchymal Stem/Stromal Cell Therapy in Patients With Diabetic Kidney Disease: A Phase I Study,TERMINATED,,PHASE1,2.0,ACTUAL,Mayo Clinic,,2.0,,Principal Investigator relocation,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,OTHER,,,,,,,2020,0.0
NCT03430479,,2018-02-06,,,2023-01-18,2018-02-06,2018-02-13,ACTUAL,,,,,,,2023-01-18,2023-01-19,ACTUAL,2017-06-22,ACTUAL,2017-06-22,2023-01,2023-01-31,2021-04-01,ACTUAL,2021-04-01,2018-11-30,ACTUAL,2018-11-30,,INTERVENTIONAL,,,Anti PD-1 Antibody With Radiation Therapy in Patients With HER2-negative Metastatic Breast Cancer,"Phase Ib/II Study to Assess Efficacy, Safety & Immunological Biomarker of Anti PD-1 Antibody With Radiation Therapy in Patients With HER2-negative Metastatic Breast Cancer",COMPLETED,,PHASE1/PHASE2,32.0,ACTUAL,Kyoto Breast Cancer Research Network,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,OTHER,,,,,,,2021,1.0
NCT01093066,,2010-03-24,,,2021-12-10,2010-03-24,2010-03-25,ESTIMATED,,,,,,,2021-12-10,2021-12-30,ACTUAL,2010-09-21,ACTUAL,2010-09-21,2021-12,2021-12-31,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,ReChiVe,,Prospective Multicentric Evaluation of a Bladder Preservation Strategy,Prospective Multicentric Evaluation of a Bladder Preservation Strategy Using a Combination of Neoadjuvant Chemotherapy and Optimal Bladder Transurethral Resection in Patients With a Urothelial Carcinoma,TERMINATED,,PHASE2,77.0,ESTIMATED,Centre Hospitalier Universitaire de Saint Etienne,,1.0,,Difficulties in the inclusion and follow-up of patients,f,,,,t,f,f,,,,,,,,,,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,OTHER,,,,,,,2020,0.0
NCT04845191,,2021-04-09,,,2021-12-14,2021-04-12,2021-04-14,ACTUAL,,,,,,,2021-12-14,2022-01-04,ACTUAL,2021-12,ESTIMATED,2021-12-31,2021-04,2021-04-30,2022-08,ESTIMATED,2022-08-31,2022-03,ESTIMATED,2022-03-31,,INTERVENTIONAL,,,COVID-19 Subcutaneously and Orally Administered Supplemental Vaccine Boost to Enhance T Cell Protection in Those Who Have Already Received EUA S-Based Vaccines,"Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of a Subcutaneously- and Orally- Administered Supplemental Spike & Nucleocapsid-targeted COVID-19 Vaccine to Enhance T Cell Based Immunogenicity in Participants Who Have Already Received Prime + Boost Vaccines Authorized For Emergency Use",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"ImmunityBio, Inc.",,2.0,,The sponsor has changed the development plans which is not for safety reasons.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,INDUSTRY,,,,,,,2022,0.0
NCT03063190,,2017-02-21,,,2021-09-29,2017-02-21,2017-02-24,ACTUAL,,,,,,,2021-09-29,2021-09-30,ACTUAL,2022-03-31,ESTIMATED,2022-03-31,2019-10,2019-10-31,2023-03,ESTIMATED,2023-03-31,2022-03-31,ESTIMATED,2022-03-31,,INTERVENTIONAL,RLS,,Cholecalciferol Supplementation in Restless Leg Syndrome in Patients With Chronic Kidney Disease,Evaluation of Cholecalciferol Supplementation in Chronic Kidney Disease Patients With Restless Leg Syndrome,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Sao Paulo General Hospital,,4.0,,the main research is no longer in the Institution,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,OTHER,,,,,,,2023,0.0
NCT02736968,,2016-04-07,2022-11-17,2022-02-24,2022-12-29,2016-04-07,2016-04-13,ESTIMATED,2022-12-29,2023-01-26,ACTUAL,2022-02-24,2022-02-28,ACTUAL,2022-12-29,2023-01-26,ACTUAL,2016-11-06,ACTUAL,2016-11-06,2020-04-21,2020-04-21,2021-03-10,ACTUAL,2021-03-10,2021-03-10,ACTUAL,2021-03-10,,INTERVENTIONAL,,"No analyses performed on the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo. Because only one participant was enrolled in Asymptomatic E. histolytica- Placebo, no analyses were performed.",Auranofin for Giardia Protozoa,"Phase IIa Randomized, Single-Blinded, Placebo-Controlled Clinical Trial of the Reprofiled Drug Auranofin for GI Protozoa",COMPLETED,,PHASE2,93.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,4.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,NIH,,,,,,,2021,1.0
NCT04433013,,2020-06-14,,,2021-11-22,2020-06-14,2020-06-16,ACTUAL,,,,,,,2021-11-22,2021-11-23,ACTUAL,2020-07,ESTIMATED,2020-07-31,2021-11,2021-11-30,2021-02,ESTIMATED,2021-02-28,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,A Randomized Controlled Trial Assessing the Efficacy of Lianhua Qingwen as an Adjuvant Treatment in Patients With Mild Symptoms of COVID-19,A Randomized Controlled Trial Assessing the Efficacy of Lianhua Qingwen as an Adjuvant Treatment in Patients With Mild Symptoms of COVID-19,WITHDRAWN,,PHASE3,0.0,ACTUAL,Nanyang Technological University,,2.0,,"Unable to find suitable site Principal Investigator. This study did not start and was withdrawn as of Aug 2020 (have updated as of Sept 2020, please proceed to update the status of study withdrawal accordingly)",f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,OTHER,,,,,,,2021,0.0
NCT04385667,,2020-05-09,,,2022-12-30,2020-05-09,2020-05-13,ACTUAL,,,,,,,2022-12-30,2023-01-03,ACTUAL,2020-05-20,ACTUAL,2020-05-20,2022-12,2022-12-31,2022-12-25,ACTUAL,2022-12-25,2022-12-01,ACTUAL,2022-12-01,,INTERVENTIONAL,,,LVN- IUS Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia,The Efficacy of Levonorgestrel Intrauterine System Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia. A Randomized Controlled Trial.,COMPLETED,,PHASE2/PHASE3,143.0,ACTUAL,Zagazig University,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,OTHER_GOV,,,,,,,2022,1.0
NCT05245916,,2022-01-26,,,2023-08-31,2022-02-08,2022-02-18,ACTUAL,,,,,,,2023-08-31,2023-09-05,ACTUAL,2022-04-14,ACTUAL,2022-04-14,2023-08,2023-08-31,2023-08-24,ACTUAL,2023-08-24,2023-08-24,ACTUAL,2023-08-24,,INTERVENTIONAL,,,IBI397 or Combination Therapies in Patients With Advanced Malignancies,"A Phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI397 or Combination Therapies in Patients With Advanced Malignancies",WITHDRAWN,,PHASE1,0.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,3.0,,Due to the company's development strategy adjustment,f,,,,f,f,f,,,,,,,,,,,2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,INDUSTRY,,,,,,,2023,0.0
NCT02631603,,2015-11-29,,,2019-03-01,2015-12-15,2015-12-16,ESTIMATED,,,,,,,2019-03-01,2019-03-04,ACTUAL,2015-04,,2015-04-30,2019-03,2019-03-31,2024-04,ESTIMATED,2024-04-30,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,chILD-EU_EAA,,Stop Exogenous Allergic Alveolitis (EAA) in Childhood,"Stop Exogenous Allergic Alveolitis (EAA) in Childhood: Healthy Into Adulthood - A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Prednisolone Treatment and Course of Disease",SUSPENDED,,PHASE2,45.0,ESTIMATED,Ludwig-Maximilians - University of Munich,,2.0,,funding pending,f,,,,t,,,,,,,,,,,,,2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,OTHER,,,,,,,2024,0.0
NCT03935555,,2019-03-14,,,2022-11-14,2019-04-30,2019-05-02,ACTUAL,,,,,,,2022-11-14,2022-11-17,ACTUAL,2019-08-12,ACTUAL,2019-08-12,2022-11,2022-11-30,2022-11-04,ACTUAL,2022-11-04,2022-10-19,ACTUAL,2022-10-19,,INTERVENTIONAL,,,"Assess the Safety, Tolerability Oral PU-H71 in Subjects Taking Ruxolitinib","Phase 1b Study of PU-H71 for the Treatment of Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), Treated With Ruxolitinib",TERMINATED,,PHASE1,11.0,ACTUAL,"Samus Therapeutics, Inc.",,4.0,,Samus Therapeutics company closure,,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,INDUSTRY,,,,,,,2022,0.0
NCT04549025,,2020-09-01,,,2024-05-21,2020-09-08,2020-09-16,ACTUAL,,,,,,,2024-05-21,2024-05-22,ACTUAL,2020-10-19,ACTUAL,2020-10-19,2024-05,2024-05-31,2024-04-25,ACTUAL,2024-04-25,2024-04-25,ACTUAL,2024-04-25,,INTERVENTIONAL,SELECT,,Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen,"Phase 2 Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab, an ICOS Agonist, in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen",TERMINATED,,PHASE2,69.0,ACTUAL,"Jounce Therapeutics, Inc.",,3.0,,"The Sponsor decided to discontinue development of pimivalimab prior to the planned study completion. At the time of the decision to discontinue development, enrollment in the study had been completed.",f,,,,t,t,f,,,t,,,,,,,,2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,INDUSTRY,,,,,,,2024,0.0
NCT02470065,,2015-06-10,,,2016-01-21,2015-06-11,2015-06-12,ESTIMATED,,,,,,,2016-01-21,2016-01-22,ESTIMATED,2016-01,,2016-01-31,2016-01,2016-01-31,2021-01,ESTIMATED,2021-01-31,2018-09,ESTIMATED,2018-09-30,,INTERVENTIONAL,REMNANT,,Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer.,Resectable EGFR Mutant NSCLC With (or Without) Afatinib as Neoadjuvant Treatment; REMNANT an Exploratory Study of the EORTC Lung Cancer Group,SUSPENDED,,PHASE2,38.0,ESTIMATED,European Organisation for Research and Treatment of Cancer - EORTC,,2.0,,Study never started,f,,,,t,,,,,,,,,,,,,2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,NETWORK,,,,,,,2021,0.0
NCT02914561,,2016-09-22,2023-10-23,,2023-11-24,2016-09-22,2016-09-26,ESTIMATED,2023-11-24,2023-12-18,ACTUAL,,,,2023-11-24,2023-12-18,ACTUAL,2016-10-31,ACTUAL,2016-10-31,2023-11,2023-11-30,2022-11-11,ACTUAL,2022-11-11,2022-11-11,ACTUAL,2022-11-11,,INTERVENTIONAL,DIVERSITY1,The All Randomized Analysis Set included all participants who were randomized in the study.,Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease,"Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease",COMPLETED,,PHASE3,1372.0,ACTUAL,Galapagos NV,,11.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,INDUSTRY,,,,,,,2022,1.0
NCT04498377,,2020-07-31,2023-10-10,,2023-12-20,2020-07-31,2020-08-04,ACTUAL,2023-12-20,2023-12-21,ACTUAL,,,,2023-12-20,2023-12-21,ACTUAL,2021-01-26,ACTUAL,2021-01-26,2023-10,2023-10-31,2021-03-24,ACTUAL,2021-03-24,2021-03-24,ACTUAL,2021-03-24,,INTERVENTIONAL,,"This study enrolled only 1 patient in F-652 arm, no patient enrolled in placebo arm.",Study of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Multicenter Study to Evaluate the Efficacy and Safety of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19",TERMINATED,,PHASE2,1.0,ACTUAL,EVIVE Biotechnology,,2.0,,There have been significant changes in the FDA guidelines and clinical standard of care,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,INDUSTRY,,,,,,,2021,0.0
NCT03481634,,2018-03-13,2022-05-27,2021-01-06,2023-01-27,2018-03-27,2018-03-29,ACTUAL,2022-10-03,2022-10-28,ACTUAL,2022-10-03,2022-10-28,ACTUAL,2023-01-27,2023-01-30,ACTUAL,2018-07-23,ACTUAL,2018-07-23,2023-01,2023-01-31,2021-10-18,ACTUAL,2021-10-18,2020-11-11,ACTUAL,2020-11-11,,INTERVENTIONAL,KESTREL,,Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema,"A Two-year, Three-arm, Randomized, Double-masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Diabetic Macular Edema",COMPLETED,,PHASE3,566.0,ACTUAL,Novartis,,3.0,,,f,,,,,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,INDUSTRY,,,,,,,2021,1.0
NCT04807309,,2021-03-15,,,2023-02-12,2021-03-17,2021-03-19,ACTUAL,,,,,,,2023-02-12,2023-02-15,ACTUAL,2021-01-01,ACTUAL,2021-01-01,2023-02,2023-02-28,2022-01-01,ACTUAL,2022-01-01,2021-11-20,ACTUAL,2021-11-20,,INTERVENTIONAL,PRETELL,,PRETELL: PREvention of TELomere-related Complications After Lung Transplant,PRETELL: PREvention of TELomere-related Complications After Lung Transplant,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Brigham and Women's Hospital,,2.0,,Lack of financial support,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,OTHER,,,,,,,2022,0.0
NCT04810494,,2021-03-14,,,2022-12-08,2021-03-18,2021-03-23,ACTUAL,,,,,,,2022-12-08,2022-12-12,ACTUAL,2022-10-01,ESTIMATED,2022-10-01,2022-12,2022-12-31,2023-06-30,ESTIMATED,2023-06-30,2023-03-31,ESTIMATED,2023-03-31,,INTERVENTIONAL,,,Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting.,Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting. A Prospective Double Blind Randomized Controlled Study.,WITHDRAWN,,PHASE4,0.0,ACTUAL,Milton S. Hershey Medical Center,,2.0,,Change in study team,f,,,,,t,f,,,f,,,,,,,,2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,OTHER,,,,,,,2023,0.0
NCT04835389,,2020-12-11,,,2021-07-02,2021-04-05,2021-04-08,ACTUAL,,,,,,,2021-07-02,2021-07-08,ACTUAL,2021-06-01,ESTIMATED,2021-06-01,2021-07,2021-07-31,2022-06-30,ESTIMATED,2022-06-30,2022-03-01,ESTIMATED,2022-03-01,,INTERVENTIONAL,,,Study of AlloGen® Liquid Intra-articular Injection for Knee Osteoarthritis,A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of AlloGen® Liquid Intra-articular Injection for Knee Osteoarthritis,WITHDRAWN,,PHASE1,0.0,ACTUAL,"VIVEX Biologics, Inc.",,2.0,,Company decision,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,INDUSTRY,,,,,,,2022,0.0
NCT04146896,,2019-10-29,2023-03-02,,2023-04-07,2019-10-30,2019-10-31,ACTUAL,2023-04-07,2023-04-28,ACTUAL,,,,2023-04-07,2023-04-28,ACTUAL,2019-11-12,ACTUAL,2019-11-12,2023-04,2023-04-30,2022-02-23,ACTUAL,2022-02-23,2022-02-23,ACTUAL,2022-02-23,,INTERVENTIONAL,,,Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN),"A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy",COMPLETED,,PHASE2,228.0,ACTUAL,Aptinyx,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,INDUSTRY,,,,,,,2022,1.0
NCT05286255,,2022-03-16,,,2024-10-01,2022-03-16,2022-03-18,ACTUAL,,,,,,,2024-10-01,2024-10-03,ACTUAL,2024-10-01,ACTUAL,2024-10-01,2024-10,2024-10-31,2024-10-01,ACTUAL,2024-10-01,2024-10-01,ACTUAL,2024-10-01,,INTERVENTIONAL,SAMPSON-1,,Mesenchymal Stromal Cells for COVID-19 and Viral Pneumonias,"Safety and Tolerability of Allogeneic Umbilical Cord Derived Mesenchymal Stromal Cells (UC-MSCs) to Limit COVID Associated ComplicatioNs: An Open Label, Phase 1 Study in Hospitalized Patients (SAMPSON-1)",WITHDRAWN,,PHASE1,0.0,ACTUAL,Medical University of South Carolina,,1.0,,Funding,f,,,,t,t,f,,,,,,Samples and Matching Participant data will be shared at the end of the study,Email to strangec@musc.edu,,YES,Biosamples are stored in the MUSC COVID-19 Biorepository,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,OTHER,,,,,,,2024,0.0
NCT04403243,,2020-05-20,,,2022-11-21,2020-05-26,2020-05-27,ACTUAL,,,,,,,2022-11-21,2022-11-25,ACTUAL,2020-05-08,ACTUAL,2020-05-08,2022-11,2022-11-30,2020-08-23,ACTUAL,2020-08-23,2020-07-22,ACTUAL,2020-07-22,,INTERVENTIONAL,COLORIT,,COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19,COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19,COMPLETED,,PHASE2,70.0,ACTUAL,Lomonosov Moscow State University Medical Research and Educational Center,,4.0,,,f,,,,f,f,f,,,,,,4 month,Medical professionals By the request,,YES,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,OTHER,,,,,,,2020,0.0
NCT04844086,,2021-04-06,,,2022-05-11,2021-04-08,2021-04-14,ACTUAL,,,,,,,2022-05-11,2022-05-18,ACTUAL,2021-03-02,ACTUAL,2021-03-02,2022-05,2022-05-31,2022-05-12,ACTUAL,2022-05-12,2022-05-12,ACTUAL,2022-05-12,,INTERVENTIONAL,,,RPM CD19-mbIL15-CAR-T Cells in Patient With Advanced Lymphoid Malignancies,Infusion of CD19-Specific Chimeric Antigen Receptor T-cells Produced by Rapid Personalized Manufacture for Patients With Advanced Lymphoid Malignancies,TERMINATED,,PHASE1,2.0,ACTUAL,Eden BioCell Ltd.,,1.0,,CAR-T manufacturing technology can not meet the dose requirement for clinical patients.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,INDUSTRY,,,,,,,2022,0.0
NCT02563002,,2015-09-28,2022-01-06,,2024-09-18,2015-09-28,2015-09-29,ESTIMATED,2022-02-23,2022-03-16,ACTUAL,,,,2024-09-18,2024-10-03,ACTUAL,2015-11-30,ACTUAL,2015-11-30,2024-09,2024-09-30,2023-07-17,ACTUAL,2023-07-17,2021-02-19,ACTUAL,2021-02-19,,INTERVENTIONAL,,All randomized participants,Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177),A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177),COMPLETED,,PHASE3,307.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,INDUSTRY,,,,,,,2023,1.0
NCT04466215,,2020-07-06,2022-12-29,,2023-01-31,2020-07-06,2020-07-10,ACTUAL,2023-01-31,2023-02-03,ACTUAL,,,,2023-01-31,2023-02-03,ACTUAL,2021-04-15,ACTUAL,2021-04-15,2023-01,2023-01-31,2022-06-07,ACTUAL,2022-06-07,2022-04-15,ACTUAL,2022-04-15,,INTERVENTIONAL,,,Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo,Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo,COMPLETED,,PHASE2,50.0,ACTUAL,The Scripps Research Institute,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,OTHER,,,,,,,2022,1.0
NCT03452488,,2018-02-13,2024-01-16,,2024-09-05,2018-02-26,2018-03-02,ACTUAL,2024-09-05,2024-10-01,ACTUAL,,,,2024-09-05,2024-10-01,ACTUAL,2017-02-07,ACTUAL,2017-02-07,2024-09,2024-09-30,2020-04-26,ACTUAL,2020-04-26,2020-04-26,ACTUAL,2020-04-26,,INTERVENTIONAL,SARA-INT,One participant randomized but not treated with 175 mg BIO101.,"A Double-blind, Placebo-controlled, Randomized INTerventional Clinical Trial (SARA-INT)","Safety and Efficacy of BIO-101 175 mg b.i.d. and 350 mg b.i.d. 26-week Oral Administration to Patients Suffering From Age-related SARcopenia, Including Sarcopenic Obesity, Aged ≥65 Years and at Risk of Mobility Disability",COMPLETED,,PHASE2,233.0,ACTUAL,Biophytis,"Due to the coronavirus disease 2019 (COVID-19) outbreak, the implementation of the clinical protocol was affected, including but not limited to the scheduled site visit for safety and/or efficacy, site visits for monitoring, investigational product delivery, collection of adverse events (AEs) and concomitant medications. This led to \>50% loss of efficacy data for the primary endpoint and other performance assessments.",3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,INDUSTRY,,,,,,,2020,1.0
NCT04791319,,2021-03-09,2023-02-01,,2023-02-01,2021-03-09,2021-03-10,ACTUAL,2023-02-01,2023-03-01,ACTUAL,,,,2023-02-01,2023-03-01,ACTUAL,2021-05-03,ACTUAL,2021-05-03,2023-02,2023-02-28,2022-03-31,ACTUAL,2022-03-31,2022-02-02,ACTUAL,2022-02-02,,INTERVENTIONAL,GENESIS,The full analysis set (FAS) included all participants who were randomized at Week 0 and received at least 1 dose of study intervention.,A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis,"A Phase 2b, Multicenter, Randomized, Placebo- and Active-comparator-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Bermekimab (JNJ-77474462) for the Treatment of Participants With Moderate to Severe Atopic Dermatitis",TERMINATED,,PHASE2,199.0,ACTUAL,"Janssen Research & Development, LLC",,4.0,,Premature Termination due to Interim Analysis (100 patients at Week 16) meeting futility.,f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,INDUSTRY,,,,,,,2022,0.0
NCT04375397,,2020-05-04,2022-04-22,,2022-05-31,2020-05-04,2020-05-05,ACTUAL,2022-05-31,2022-06-01,ACTUAL,,,,2022-05-31,2022-06-01,ACTUAL,2020-06-06,ACTUAL,2020-06-06,2022-05,2022-05-31,2021-06-08,ACTUAL,2021-06-08,2021-05-10,ACTUAL,2021-05-10,,INTERVENTIONAL,iNSPIRE,Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug,Study of Oral Ibrutinib Capsules to Assess Respiratory Failure in Adult Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and Pulmonary Injury,IbrutiNib in SARS CoV-2 Induced Pulmonary Injury and Respiratory Failure (iNSPIRE),COMPLETED,,PHASE2,46.0,ACTUAL,AbbVie,,2.0,,,f,,,,t,t,f,,,t,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.",Requests for access to individual participant data from ibrutinib clinical studies conducted by AbbVie can be submitted through Yale Open Data Access (YODA) Project site at http://yoda.yale.edu,http://yoda.yale.edu/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,INDUSTRY,,,,,,,2021,1.0
NCT05033080,,2021-08-26,2024-05-10,,2024-09-18,2021-08-26,2021-09-02,ACTUAL,2024-06-07,2024-06-10,ACTUAL,,,,2024-09-18,2024-10-03,ACTUAL,2021-09-14,ACTUAL,2021-09-14,2024-09,2024-09-30,2023-11-21,ACTUAL,2023-11-21,2023-05-12,ACTUAL,2023-05-12,,INTERVENTIONAL,,All randomized participants who carry the intended CFTR genotype and received at least 1 dose of study drug in a study.,A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF),"A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)",COMPLETED,,PHASE3,435.0,ACTUAL,Vertex Pharmaceuticals Incorporated,,2.0,,,f,,,,,t,f,,,,,,,,,NO,Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,INDUSTRY,,,,,,,2023,1.0
NCT02715505,,2016-03-16,,,2018-11-26,2016-03-16,2016-03-22,ESTIMATED,,,,,,,2018-11-26,2018-11-28,ACTUAL,2017-10-10,ESTIMATED,2017-10-10,2018-11,2018-11-30,2020-05-18,ESTIMATED,2020-05-18,2020-05-18,ESTIMATED,2020-05-18,,INTERVENTIONAL,,,Safety and Exploratory Efficacy of HSC835 in Patients With Inherited Metabolic Disorders (IMD),"A Single-arm, Open-label, Study to Evaluate the Safety and Exploratory Efficacy of HSC835 in Patients With Inherited Metabolic Disorders (IMD) Undergoing Stem Cell Transplantation After Reduced Intensity Conditioning",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Novartis,,1.0,,This study was cancelled with no patients,f,,,,t,t,f,,,,,,,,,UNDECIDED,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,INDUSTRY,,,,,,,2020,0.0
NCT03931915,,2019-04-24,,,2020-12-10,2019-04-26,2019-04-30,ACTUAL,,,,,,,2020-12-10,2020-12-11,ACTUAL,2019-05-08,ACTUAL,2019-05-08,2020-07,2020-07-31,2020-09-28,ACTUAL,2020-09-28,2020-06-12,ACTUAL,2020-06-12,,INTERVENTIONAL,,,Clinical Study to Evaluate Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in Patients With Endometriosis,Phase III Clinical Study to Evaluate Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in Patients With Endometriosis,COMPLETED,,PHASE3,335.0,ACTUAL,"ASKA Pharmaceutical Co., Ltd.",,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,INDUSTRY,,,,,,,2020,1.0
NCT04094584,,2019-09-17,2023-05-01,,2023-05-26,2019-09-17,2019-09-19,ACTUAL,2023-05-26,2023-06-22,ACTUAL,,,,2023-05-26,2023-06-22,ACTUAL,2020-08-14,ACTUAL,2020-08-14,2023-05,2023-05-31,2022-05-01,ACTUAL,2022-05-01,2022-05-01,ACTUAL,2022-05-01,,INTERVENTIONAL,,,Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder,Feasibility of Emergency Department Initiated Extended-Release Naltrexone and Case Management Services for the Treatment of Alcohol Use Disorder,TERMINATED,,PHASE4,179.0,ACTUAL,"University of California, San Francisco",,1.0,,12 month follow up data not collected due to pandemic disruptions,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,OTHER,,,,,,,2022,0.0
NCT04369742,,2020-04-25,2022-03-31,,2022-04-20,2020-04-29,2020-04-30,ACTUAL,2022-04-20,2022-04-22,ACTUAL,,,,2022-04-20,2022-04-22,ACTUAL,2020-04-15,ACTUAL,2020-04-15,2022-04,2022-04-30,2021-04-01,ACTUAL,2021-04-01,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,,,Treating COVID-19 With Hydroxychloroquine (TEACH),"Treating COVID-19 With Hydroxychloroquine: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial in Hospitalized Adults",TERMINATED,,PHASE2,128.0,ACTUAL,NYU Langone Health,,2.0,,Investigator decision,f,,,,t,t,f,,,t,,,Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.,"Requests should be directed to mark.mulligan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.",,YES,The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: \[contact information for PI or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,OTHER,,,,,,,2021,0.0
NCT04999098,,2021-08-04,,,2024-08-05,2021-08-04,2021-08-10,ACTUAL,,,,,,,2024-08-05,2024-08-06,ACTUAL,2021-11-15,ACTUAL,2021-11-15,2024-08,2024-08-31,2023-08-15,ACTUAL,2023-08-15,2023-05-15,ACTUAL,2023-05-15,,INTERVENTIONAL,,,Echinaforce COVID-19 Shedding Study,"Randomized, Controlled, 3-arm, Open, Prospective Clinical Trial to Assess Antiviral Properties of Echinacea Reducing Oropharyngeal Concentration and Infectivity of SARS-CoV-2: The Shedding Study",TERMINATED,,PHASE4,40.0,ACTUAL,A. Vogel AG,,3.0,,insufficient recruitment,f,,,,f,f,f,,,f,,,,,,UNDECIDED,There is no plan yet,2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,INDUSTRY,,,,,,,2023,0.0
NCT02008357,,2013-12-06,2023-12-14,,2023-12-14,2013-12-06,2013-12-11,ESTIMATED,2023-12-14,2023-12-28,ACTUAL,,,,2023-12-14,2023-12-28,ACTUAL,2014-02-28,ACTUAL,2014-02-28,2023-12,2023-12-31,2023-06-08,ACTUAL,2023-06-08,2022-12-27,ACTUAL,2022-12-27,,INTERVENTIONAL,A4,All randomized participants.,Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss,Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study),COMPLETED,,PHASE3,1169.0,ACTUAL,Eli Lilly and Company,"Per protocol and SAP, delayed-start analyses were not conducted because no treatment difference was observed at the end of the double-blind (placebo-controlled) period. Hence, data were not evaluated for outcome measure analyses (week 336), but safety data were analyzed for open-label extension period.",2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,INDUSTRY,,,,,,,2023,1.0
NCT04598269,,2020-10-05,2023-08-28,2022-03-10,2023-09-26,2020-10-20,2020-10-22,ACTUAL,2023-09-26,2023-09-28,ACTUAL,,2023-09-28,ACTUAL,2023-09-26,2023-09-28,ACTUAL,2020-09-30,ACTUAL,2020-09-30,2023-09,2023-09-30,2021-04-22,ACTUAL,2021-04-22,2021-04-08,ACTUAL,2021-04-08,,INTERVENTIONAL,,All participants who received 1 dose of study drug.,Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis,"A Phase 2a, Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis",COMPLETED,,PHASE2,50.0,ACTUAL,"Aclaris Therapeutics, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,INDUSTRY,,,,,,,2021,1.0
NCT05178862,,2021-12-16,,,2023-11-14,2021-12-16,2022-01-05,ACTUAL,,,,,,,2023-11-14,2023-11-18,ACTUAL,2022-08-03,ACTUAL,2022-08-03,2023-11,2023-11-30,2024-08,ESTIMATED,2024-08-31,2024-06,ESTIMATED,2024-06-30,,INTERVENTIONAL,MARIO,,"A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole","A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO)",SUSPENDED,,PHASE3,220.0,ESTIMATED,"Scynexis, Inc.",,2.0,,"During a review of manufacturing equipment and cleaning activities at a supplier that manufactured study drug for this study, SCYNEXIS was made aware of potential cross-contamination risk with a non-antibacterial beta-lactam drug substance.",f,,,,,t,f,,,,,,,,,,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,INDUSTRY,,,,,,,2024,0.0
NCT03993236,,2019-06-17,,,2024-10-01,2019-06-19,2019-06-20,ACTUAL,,,,,,,2024-10-01,2024-10-03,ACTUAL,2019-09-09,ACTUAL,2019-09-09,2024-10,2024-10-31,2021-09-27,ACTUAL,2021-09-27,2021-09-27,ACTUAL,2021-09-27,,INTERVENTIONAL,,,Study on Rosuvastatin+Ezetimibe and Rosuvastatin for LDL-C Goal in Patients With Recent Ischemic Stroke,Moderate-intensity Rosuvastatin Plus Ezetimibe Versus High-intensity Rosuvastatin for Target LDL-C Goal Achievement in Patients With Recent Ischemic Stroke: a Randomized Clinical Trial,COMPLETED,,PHASE4,584.0,ACTUAL,Inje University,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,OTHER,,,,,,,2021,1.0
NCT04778059,,2021-02-26,2023-09-11,,2023-11-29,2021-02-26,2021-03-02,ACTUAL,2023-11-29,2023-12-01,ACTUAL,,,,2023-11-29,2023-12-01,ACTUAL,2021-07-27,ACTUAL,2021-07-27,2023-11,2023-11-30,2022-05-10,ACTUAL,2022-05-10,2022-05-10,ACTUAL,2022-05-10,,INTERVENTIONAL,,All enrolled subjects who received a USB002 or Placebo infusion were included in the analysis population for all outcomes analyzed.,Safety and Efficacy of USB002 for Respiratory Distress Due to COVID-19,"Phase 2 Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravenous USB002 to Treat Patients With Respiratory Distress Due to COVID-19 Infection",TERMINATED,,PHASE2,21.0,ACTUAL,"US Biotest, Inc.","Per protocol, this clinical trial was designed to include two parts (Part 1 - dose escalation phase; Part 2 - dose expansion phase). Part 2 did not proceed due to enrolment difficulty. Sponsor encountered challenges in finding subjects that met study eligibility criteria. This was likely due to the role COVID-19 vaccinations played, limiting the spread and hospitalizations of COVID-19 patients. Sponsor terminated the trial early, when 21 subjects (all Part 1) had been enrolled.",2.0,,Unable to enroll in timely manner due to nature of COVID,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,INDUSTRY,,,,,,,2022,0.0
NCT03928808,,2019-04-23,,,2023-01-26,2019-04-23,2019-04-26,ACTUAL,,,,,,,2023-01-26,2023-01-30,ACTUAL,2023-04-01,ESTIMATED,2023-04-01,2023-01,2023-01-31,2024-09,ESTIMATED,2024-09-30,2024-03,ESTIMATED,2024-03-31,,INTERVENTIONAL,,,Fecal Microbiota Transplantation (FMT) in Treatment of Severe and Enduring Anorexia Nervosa,Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Severe and Enduring Anorexia Nervosa (SE-AN),WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,"University of North Carolina, Chapel Hill",,1.0,,Withdrawn due to covid-19 protocols on inpatient eating disorders unit.,f,,,,t,t,f,,,,,,6 months after publication of the primary publication,To qualified applicants with documented IRB approval and analytic plan. A Data Use Agreement must be executed with UNC prior to actual sharing of data.,,YES,"Deidentified individual participant data (IPD) will be made available by controlled access. Qualified researchers with documented evidence of ethical approval and a clear research and statistical analysis plan will be given access through a secure file transfer protocol (FTP) site. Data to be shared include diagnostic information, age, non-identifying demographic data (including BMI and other anthropometric measures), psychometric, and sequence data along with a data dictionary.",2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,OTHER,,,,,,,2024,0.0
NCT04509726,,2020-08-10,,,2024-09-30,2020-08-10,2020-08-12,ACTUAL,,,,,,,2024-09-30,2024-10-02,ACTUAL,2023-03-01,ACTUAL,2023-03-01,2024-09,2024-09-30,2024-12,ESTIMATED,2024-12-31,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,EBV Specific Cytokine Secreting TCR-T Cells in the Treatment of EBV-Positive Metastatic/Refractory Nasopharyngeal Carcinoma,Single-Arm Trial of EBV Specific Cytokine Secreting TCR-T Cells in the Treatment of EBV-Positive Head and Neck Carcinoma Metastatic/Refractory Nasopharyngeal Carcinoma,SUSPENDED,,PHASE1/PHASE2,20.0,ESTIMATED,Xinqiao Hospital of Chongqing,,1.0,,Scheduled Pause,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,OTHER,,,,,,,2024,0.0
NCT03963102,,2019-03-19,,,2024-07-25,2019-05-23,2019-05-24,ACTUAL,,,,,,,2024-07-25,2024-07-26,ACTUAL,2019-10-30,ACTUAL,2019-10-30,2024-07,2024-07-31,2024-03-31,ACTUAL,2024-03-31,2024-03-31,ACTUAL,2024-03-31,,INTERVENTIONAL,,,Duration of Ameluz Application in Acral Actinic Keratoses Response,A Study to Investigate the Effect of Different Durations of Ameluz Application on Response to Treatment of Acral Actinic Keratoses,TERMINATED,,PHASE4,28.0,ACTUAL,Royal Cornwall Hospitals Trust,,2.0,,"Lack of appropriate personnel. Dr Xie abroad on other research, current PI Dr John Frewen not at main centre, no other available PI identified. Study suspended.",f,,,,t,f,f,,,f,,,,,,NO,Please contact study coordinators to see if non-patient identifiable information can be release.,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,OTHER,,,,,,,2024,0.0
NCT05044936,,2021-07-21,,,2023-05-15,2021-09-09,2021-09-16,ACTUAL,,,,,,,2023-05-15,2023-05-17,ACTUAL,2023-05-15,ACTUAL,2023-05-15,2023-05,2023-05-31,2023-05-15,ESTIMATED,2023-05-15,2023-05-15,ACTUAL,2023-05-15,,INTERVENTIONAL,,,Topical Cannabidiol Cream and Post-exercise Recovery,The Effects of Topical Cannabidiol Cream on Post-exercise Recovery,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of New Mexico,,1.0,,"The researchers were not able to acquire funding to initiate the study. Also, the study was not approved by the local IRB which requested a FDA new drug application.",f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 22:33:05.572878,2024-10-16 22:33:05.572878,OTHER,,,,,,,2023,0.0
NCT04675021,,2020-11-12,,,2021-01-25,2020-12-14,2020-12-19,ACTUAL,,,,,,,2021-01-25,2021-01-26,ACTUAL,2020-11-13,ACTUAL,2020-11-13,2021-01,2021-01-31,2021-01-11,ACTUAL,2021-01-11,2021-01-11,ACTUAL,2021-01-11,,INTERVENTIONAL,,,Absolute Bioavailability and ADME Study of Savolitinib in Healthy Male Subjects,"A Phase I Open-label Study to Assess the Absolute Bioavailability of Savolitinib and Absorption, Distribution, Metabolism, Excretion of [14C]Savolitinib in Healthy Male Subjects",COMPLETED,,PHASE1,8.0,ACTUAL,AstraZeneca,,1.0,,,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the AZ approved data access tool to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,INDUSTRY,,,,,,,2021,1.0
NCT00352027,,2006-07-13,2016-04-27,,2023-09-01,2006-07-13,2006-07-14,ESTIMATED,2016-09-19,2016-10-07,ESTIMATED,,,,2023-09-01,2023-09-22,ACTUAL,2006-07-20,ACTUAL,2006-07-20,2023-09,2023-09-30,2022-11-15,ACTUAL,2022-11-15,2015-05,ACTUAL,2015-05-31,,INTERVENTIONAL,,,Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma,Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma,COMPLETED,,PHASE2,81.0,ACTUAL,St. Jude Children's Research Hospital,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,OTHER,,,,,,,2022,1.0
NCT04399551,,2020-05-18,2023-03-06,,2024-04-04,2020-05-18,2020-05-22,ACTUAL,2023-04-24,2023-05-19,ACTUAL,,,,2024-04-04,2024-04-05,ACTUAL,2020-09-28,ACTUAL,2020-09-28,2024-04,2024-04-30,2023-03-13,ACTUAL,2023-03-13,2022-03-07,ACTUAL,2022-03-07,,INTERVENTIONAL,,,A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries,"A Phase IIIb, Open-label, Hybrid Type III Trial Evaluating Implementation Strategies for Long-acting Cabotegravir Plus Long-acting Rilpivirine Every Two Months in HIV-1 Infected, Virologically Suppressed Adults in Select European Healthcare Settings",COMPLETED,,PHASE3,437.0,ACTUAL,ViiV Healthcare,,2.0,,,f,,,,f,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,INDUSTRY,,,,,,,2023,1.0
NCT05787028,,2023-03-01,,,2023-11-28,2023-03-14,2023-03-28,ACTUAL,,,,,,,2023-11-28,2023-12-01,ACTUAL,2019-01-30,ACTUAL,2019-01-30,2023-11,2023-11-30,2020-05-31,ACTUAL,2020-05-31,2020-05-31,ACTUAL,2020-05-31,,INTERVENTIONAL,AD16,,"Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration","Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration",COMPLETED,,PHASE1,70.0,ACTUAL,South China Center For Innovative Pharmaceuticals,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,OTHER,,,,,,,2020,1.0
NCT04279938,,2018-01-12,,,2020-02-19,2020-02-19,2020-02-21,ACTUAL,,,,,,,2020-02-19,2020-02-21,ACTUAL,2018-09,ESTIMATED,2018-09-30,2020-02,2020-02-29,2021-01,ESTIMATED,2021-01-31,2020-03,ESTIMATED,2020-03-31,,INTERVENTIONAL,,,"A Phase Ib Combination Study of Rituximab, TinostamustinEAnd CHeckpoint Inhibition With Pembrolizumab in Relapsed/Refractory DLBCL","A Phase Ib Combination Study of Rituximab, TinostamustinEAnd CHeckpoint Inhibition With Pembrolizumab in Relapsed/Refractory DLBCL - REACH",WITHDRAWN,,PHASE1,0.0,ACTUAL,Royal Marsden NHS Foundation Trust,,1.0,,Safety data on drug,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,OTHER,,,,,,,2021,0.0
NCT04139057,,2019-10-23,,,2024-09-30,2019-10-23,2019-10-25,ACTUAL,,,,,,,2024-09-30,2024-10-02,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2024-09,2024-09-30,2024-12-01,ESTIMATED,2024-12-01,2024-12-01,ESTIMATED,2024-12-01,,INTERVENTIONAL,,,EBV-Specific Anti-PD1 TCR-T Cells in the Treatment of EBV-Positive NHSCC,Single-Arm Trial of EBV-Specific TCR-T Cells With Anti-PD1 Auto-secreted Element in the Treatment of EBV-Positive Head and Neck Carcinoma,SUSPENDED,,PHASE1/PHASE2,18.0,ESTIMATED,Xinqiao Hospital of Chongqing,,1.0,,Scheduled Pause,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,OTHER,,,,,,,2024,0.0
NCT04025177,,2019-05-27,,,2021-09-28,2019-07-16,2019-07-18,ACTUAL,,,,,,,2021-09-28,2021-10-06,ACTUAL,2020-01,ESTIMATED,2020-01-31,2020-03,2020-03-31,2022-02,ESTIMATED,2022-02-28,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,INDO,,Indomethacin PK-PD in Extremely Preterm Neonates,Pharmacokinetics and Pharmacodynamics of Indomethacin Used for PDA Treatment in Extremely Preterm Neonates <27 Weeks Gestational Age,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Manitoba,,1.0,,Halted due to feasibility issues,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,OTHER,,,,,,,2022,0.0
NCT04399356,,2020-05-19,2022-04-04,,2022-04-08,2020-05-21,2020-05-22,ACTUAL,2022-04-08,2022-04-12,ACTUAL,,,,2022-04-08,2022-04-12,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2022-04,2022-04-30,2021-08-19,ACTUAL,2021-08-19,2021-04-20,ACTUAL,2021-04-20,,INTERVENTIONAL,,,Niclosamide for Mild to Moderate COVID-19,Niclosamide for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19),COMPLETED,,PHASE2,73.0,ACTUAL,Tufts Medical Center,"There was a precipitous and persistent decrease in the rate of COVID-19 diagnoses in spring and summer 2021 that decreased our enrollment pool. Additionally, as vaccination rates rose, our predetermined exclusion criteria of individuals vaccinated against SARS-CoV-2 limited those available for enrollment.",2.0,,,,,,,f,t,f,,,f,,,,,,,,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,OTHER,,,,,,,2021,0.0
NCT05170789,,2021-10-11,,,2022-04-27,2021-12-08,2021-12-28,ACTUAL,,,,,,,2022-04-27,2022-05-04,ACTUAL,2022-04-27,ACTUAL,2022-04-27,2022-04,2022-04-30,2022-04-27,ACTUAL,2022-04-27,2022-04-27,ACTUAL,2022-04-27,,INTERVENTIONAL,ESdRRMM,,"Elotuzumab, Selinexor, and Dexamethasone for Relapsed Refractory Multiple Myeloma","A Phase II, Single-Arm, Study of Elotuzumab, Selinexor, and Dexamethasone in Patients With Relapsed Refractory Multiple Myeloma",WITHDRAWN,,PHASE2,0.0,ACTUAL,Tulane University,,1.0,,"The study collaborator -Karyopharm- is not doing Myeloma studies funding, so they let the study investigators know they are not funding the study anymore.",f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,OTHER,,,,,,,2022,0.0
NCT04614142,,2020-10-28,,,2022-03-04,2020-10-28,2020-11-03,ACTUAL,,,,,,,2022-03-04,2022-03-08,ACTUAL,2020-11-13,ACTUAL,2020-11-13,2022-03,2022-03-31,2021-08-04,ACTUAL,2021-08-04,2021-08-04,ACTUAL,2021-08-04,,INTERVENTIONAL,,,Single Patient Protocol for Donor HCV-positive to Recipient HCV-negative Kidney Transplant in a Patient at Risk for Loss of Dialysis Access,Single Patient Protocol for Donor HCV-positive to Recipient HCV-negative Kidney Transplant in a Patient at Risk for Loss of Dialysis Access,WITHDRAWN,,PHASE4,0.0,ACTUAL,Massachusetts General Hospital,,1.0,,Single patient the protocol was written for consented to another study.,f,,,,t,t,f,,,t,,,,,,NO,Data will not be shared outside of the research team.,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,OTHER,,,,,,,2021,0.0
NCT05920408,,2023-05-18,,,2023-11-06,2023-06-26,2023-06-27,ACTUAL,,,,,,,2023-11-06,2023-11-08,ACTUAL,2023-04-11,ACTUAL,2023-04-11,2023-11,2023-11-30,2023-10-23,ACTUAL,2023-10-23,2023-09-27,ACTUAL,2023-09-27,,INTERVENTIONAL,,,Study to Assess EXS21546 in Combination in Patients With Advanced Solid Tumours,"A Phase 1B/2A Study to Assess the Safety, Tolerability, Pharmacokinetic and Anti-tumoral Activity of EXS21546 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumours",TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,Exscientia AI Limited,,1.0,,Emerging data demonstrates challenge for EXS21546 to reach suitable therapeutic index.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,INDUSTRY,,,,,,,2023,0.0
NCT04450394,,2020-06-26,2022-10-06,,2022-10-06,2020-06-26,2020-06-29,ACTUAL,2022-10-06,2022-11-02,ACTUAL,,,,2022-10-06,2022-11-02,ACTUAL,2020-07-01,ACTUAL,2020-07-01,2022-10,2022-10-31,2021-10-08,ACTUAL,2021-10-08,2021-10-08,ACTUAL,2021-10-08,,INTERVENTIONAL,,All randomized participants.,A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus,"A Phase 2, Parallel, Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Insulin-Naïve Patients With Type 2 Diabetes Mellitus",COMPLETED,,PHASE2,278.0,ACTUAL,Eli Lilly and Company,"The study was initially designed as 3 arms: LY3209590 Algorithm 1 (Paper), LY3209590 Algorithm 2 (Digital), and Insulin Degludec. However, it was amended to terminate the LY3209590 Algorithm 2 (Digital) arm during early enrollment phase due to technical issues with data entry. Thus, this arm was excluded from the outcome measure analyses, but safety data was analysed and reported.",3.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,INDUSTRY,,,,,,,2021,1.0
NCT03826199,,2019-01-25,2023-01-05,,2023-11-28,2019-01-30,2019-02-01,ACTUAL,2023-03-13,2023-03-16,ACTUAL,,,,2023-11-28,2023-12-01,ACTUAL,2019-08-23,ACTUAL,2019-08-23,2023-11,2023-11-30,2023-09-30,ACTUAL,2023-09-30,2021-12-01,ACTUAL,2021-12-01,,INTERVENTIONAL,PrEP-PP,200 pregnant women enrolled in formative study and followed for 12 months postpartum,Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study),"Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town, South Africa (Formative Study)",COMPLETED,,PHASE4,200.0,ACTUAL,"University of California, Los Angeles",,,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,OTHER,,,,,,,2023,1.0
NCT03544099,,2018-05-21,,,2023-04-09,2018-05-31,2018-06-01,ACTUAL,,,,,,,2023-04-09,2023-04-11,ACTUAL,2019-05-07,ACTUAL,2019-05-07,2023-04,2023-04-30,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Pembrolizumab for Nasopharyngeal Carcinoma Patients With Detectable Plasma Epstein-Barr Virus DNA,Pembrolizumab for Nasopharyngeal Carcinoma Patients With Detectable Plasma Epstein-Barr Virus DNA But Without Clinically Detectable Residual Diseases and/or Metastases After Curative Chemoradiation - A Single Arm Phase II Trial,TERMINATED,,PHASE2,2.0,ACTUAL,"National Health Research Institutes, Taiwan",,1.0,,Difficult to recruit Nasopharyngeal Carcinoma Patients With Detectable Plasma Epstein-Barr Virus DNA,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,OTHER,,,,,,,2021,0.0
NCT03762447,,2018-11-19,,,2023-11-28,2018-11-30,2018-12-03,ACTUAL,,,,,,,2023-11-28,2023-11-29,ACTUAL,2018-12-10,ACTUAL,2018-12-10,2023-11,2023-11-30,2023-11-17,ACTUAL,2023-11-17,2023-11-17,ACTUAL,2023-11-17,,INTERVENTIONAL,,,"A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors","A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors",COMPLETED,,PHASE1,138.0,ACTUAL,Incyte Corporation,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,INDUSTRY,,,,,,,2023,1.0
NCT02520427,,2015-06-17,2023-04-17,,2024-02-15,2015-08-07,2015-08-11,ESTIMATED,2024-02-15,2024-07-31,ACTUAL,,,,2024-02-15,2024-07-31,ACTUAL,2015-08-31,ACTUAL,2015-08-31,2024-02,2024-02-29,2022-01-09,ACTUAL,2022-01-09,2022-01-09,ACTUAL,2022-01-09,,INTERVENTIONAL,,,A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies,"A Phase 1 First-in-human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 330 Administered as Continuous Intravenous Infusion in Subjects With Myeloid Malignancies",TERMINATED,,PHASE1,95.0,ACTUAL,Amgen,"Group 5 dose-escalation cohort and dose-expansion cohorts were not enrolled in the study, due to the study terminating early.",5.0,,"Amgen strategic business decision to cancel following portfolio review, re-prioritization.",f,,,,f,,,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,INDUSTRY,,,,,,,2022,0.0
NCT03826628,,2019-01-29,2023-07-19,,2023-08-17,2019-01-30,2019-02-01,ACTUAL,2023-08-09,2023-08-14,ACTUAL,,,,2023-08-17,2023-09-08,ACTUAL,2019-07-28,ACTUAL,2019-07-28,2022-07,2022-07-31,2022-09-01,ACTUAL,2022-09-01,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,,,Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex,"A Phase 2/3, Multi-Center, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Dose-Response Comparison of the Efficacy and Safety of a Topical Rapamycin Cream for the Treatment of Facial Angiofibromas (FA) Associated With Tuberous Sclerosis Complex (TSC) in Patients 6 Years of Age and Over",COMPLETED,,PHASE2/PHASE3,107.0,ACTUAL,Dermatology Specialties Limited Partnership,"Covid-19 pandemic halted recruitment, leading to a smaller number of patients recruited than intended (107/120).",3.0,,,f,,,,f,t,f,,,,,,,,,NO,Individual Participant Data is not planned to be shared with other researchers,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,INDUSTRY,,,,,,,2022,1.0
NCT02976701,,2016-11-21,,,2023-09-06,2016-11-24,2016-11-29,ESTIMATED,,,,,,,2023-09-06,2023-09-08,ACTUAL,2016-11,,2016-11-30,2023-09,2023-09-30,2023-03,ACTUAL,2023-03-31,2023-01,ACTUAL,2023-01-31,,INTERVENTIONAL,,,Effect of DLBS1033 After Primary PCI in Patients With STE-ACS,The Effect of DLBS1033 in Patients With ST Elevation Acute Coronary Syndrome (STE-ACS) After Primary Percutaneous Coronary Intervention,TERMINATED,,PHASE2/PHASE3,23.0,ACTUAL,Dexa Medica Group,,2.0,,The investigational cases were no longer relevant considering the recent implementation of our current national healthcare system.,f,,,,t,,,,,,,,,,,,,2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,INDUSTRY,,,,,,,2023,0.0
NCT05205161,,2022-01-05,,,2023-08-31,2022-01-05,2022-01-25,ACTUAL,,,,,,,2023-08-31,2023-09-05,ACTUAL,2022-07-05,ACTUAL,2022-07-05,2023-08,2023-08-31,2023-08-17,ACTUAL,2023-08-17,2023-08-17,ACTUAL,2023-08-17,,INTERVENTIONAL,,,A Phase I/II Study of AZD0466 as Monotherapy or in Combination With Anticancer Agents in Advanced Non-Hodgkin Lymphoma,"A Modular Phase I/II, Open-label, Dose Escalation and Expansion, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0466 as Monotherapy or in Combination With Anticancer Agents in Patients With Advanced Non-Hodgkin Lymphoma.",TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,AstraZeneca,,8.0,,Due to safety reasons.,,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:~https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patientlevel data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:~https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,INDUSTRY,,,,,,,2023,0.0
NCT03689244,,2018-09-27,2023-06-06,,2024-06-20,2018-09-27,2018-09-28,ACTUAL,2023-07-20,2023-08-09,ACTUAL,,,,2024-06-20,2024-06-21,ACTUAL,2019-01-23,ACTUAL,2019-01-23,2024-06,2024-06-30,2022-06-07,ACTUAL,2022-06-07,2022-06-07,ACTUAL,2022-06-07,,INTERVENTIONAL,SELECT,,A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment,"A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential, Adaptive, Phase 3 Study With Open-label Extension Period to Assess the Efficacy and Safety of Selexipag as an add-on to Standard of Care Therapy in Subjects With Inoperable or Persistent/Recurrent After Surgical and/or Interventional Treatment Chronic Thromboembolic Pulmonary Hypertension",TERMINATED,,PHASE3,128.0,ACTUAL,Actelion,"Failure to meet success on the primary outcome measure led to termination of the study for futility and thus the pre-planned testing hierarchy was no longer applicable, and all efficacy analyses other than the primary endpoint (PVR) were exploratory.",3.0,,"The study did not demonstrate efficacy on the primary endpoint, PVR vs. placebo at wk 20 at a planned interim analysis.",f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"Actelion is a Janssen pharmaceutical company of Johnson \& Johnson. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials\\transparency.~As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu",2024-10-15 01:03:51.046671,2024-10-15 01:03:51.046671,INDUSTRY,,,,,,,2022,0.0
NCT03263767,,2017-08-21,,,2022-07-13,2017-08-23,2017-08-28,ACTUAL,,,,,,,2022-07-13,2022-07-15,ACTUAL,2018-01-15,ACTUAL,2018-01-15,2022-07,2022-07-31,2022-06-21,ACTUAL,2022-06-21,2021-10-21,ACTUAL,2021-10-21,,INTERVENTIONAL,CYRIC,,Post Transplant Cyclophosphamide (PTCY) as Sole Graft Versus Host Disease (GVHD) Prophylaxis for Matched Allotransplant: CYRIC,Phase II Study Testing Prophylaxis Feasibility of Graft Versus Host Disease With Only High Dose Cyclophosphamide Post-transplantation for Patients Eligible to a Reduced-intensity Conditioning Regiment Prior to Allogenic Transplantation With a Compatible Familial or Non-familial Donor.,TERMINATED,,PHASE2,47.0,ACTUAL,Nantes University Hospital,,4.0,,Security criteria (MTD),f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,OTHER,,,,,,,2022,0.0
NCT04579133,,2020-10-01,,,2021-06-14,2020-10-01,2020-10-08,ACTUAL,,,,,,,2021-06-14,2021-06-16,ACTUAL,2021-03-01,ACTUAL,2021-03-01,2021-06,2021-06-30,2021-03-01,ACTUAL,2021-03-01,2021-03-01,ACTUAL,2021-03-01,,INTERVENTIONAL,,,Neoadjuvant Durvalumab Alone Versus Durvalumab With Olaparib in Patients Ineligible for Cisplatin With Muscle-Invasive Urothelial Carcinoma of the Bladder Followed by Radical Cystectomy,Phase II Randomized Study of Neoadjuvant Durvalumab (MEDI4736) Alone Versus Durvalumab (MEDI4736) With Olaparib (AZD2281) in Patients Ineligible for Cisplatin With Muscle-Invasive Urothelial Carcinoma of the Bladder Followed by Radical Cystectomy,TERMINATED,,PHASE2,140.0,ACTUAL,Latin American Cooperative Oncology Group,,2.0,,Not approved,f,,,,f,f,f,,,f,,,,,,,,2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,OTHER,,,,,,,2021,0.0
NCT04017832,,2019-07-11,2022-10-26,,2024-09-27,2019-07-11,2019-07-12,ACTUAL,2023-09-28,2023-09-29,ACTUAL,,,,2024-09-27,2024-10-01,ACTUAL,2019-07-29,ACTUAL,2019-07-29,2024-09,2024-09-30,2021-10-27,ACTUAL,2021-10-27,2021-10-27,ACTUAL,2021-10-27,,INTERVENTIONAL,PIONEER 12,Full analysis set (FAS) included all randomized participants.,A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes,China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus Treated With Metformin,COMPLETED,,PHASE3,1441.0,ACTUAL,Novo Nordisk A/S,,4.0,,,f,,,,f,f,f,,,,,,,,,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,INDUSTRY,,,,,,,2021,1.0
NCT04086212,,2019-09-02,,,2024-09-30,2019-09-10,2019-09-11,ACTUAL,,,,,,,2024-09-30,2024-10-01,ACTUAL,2019-10-02,ACTUAL,2019-10-02,2022-03,2022-03-31,2023-04,ESTIMATED,2023-04-30,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine,"Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine Compared to Icodextrin Alone, an Exploratory Study.",WITHDRAWN,,PHASE2,0.0,ACTUAL,Iperboreal Pharma Srl,,2.0,,The study never started,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,INDUSTRY,,,,,,,2023,0.0
NCT02625610,,2015-12-04,2021-09-30,2019-10-10,2022-05-11,2015-12-04,2015-12-09,ESTIMATED,2021-11-03,2021-11-04,ACTUAL,2019-10-10,2019-10-21,ACTUAL,2022-05-11,2022-06-09,ACTUAL,2015-12-24,ACTUAL,2015-12-24,2022-05,2022-05-31,2021-06-03,ACTUAL,2021-06-03,2019-09-13,ACTUAL,2019-09-13,,INTERVENTIONAL,,Full analysis set included all randomized participants included in treatment arm to which they were randomized.,Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100),"A Phase III Open-label, Multicenter Trial of Maintenance Therapy With Avelumab (MSB0010718C) Versus Continuation of First-line Chemotherapy in Subjects With Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro-esophageal Junction",COMPLETED,,PHASE3,499.0,ACTUAL,EMD Serono,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,INDUSTRY,,,,,,,2021,1.0
NCT04869943,,2021-04-27,,,2024-01-24,2021-04-30,2021-05-03,ACTUAL,,,,,,,2024-01-24,2024-01-26,ACTUAL,2021-10-12,ACTUAL,2021-10-12,2024-01,2024-01-31,2024-01-09,ACTUAL,2024-01-09,2024-01-09,ACTUAL,2024-01-09,,INTERVENTIONAL,ARTEST,,Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer,"Randomized Crossover Ph3 to Evaluate Efficacy/Safety of Enobosarm Monotherapy vs Active Control for Treatment of AR+/ER+/HER2- MBC With AR Staining Previously Treated w/Nonsteroidal Aromatase Inhibitor, SERD & CDK 4/6 Inhibitor",TERMINATED,,PHASE3,52.0,ACTUAL,Veru Inc.,,2.0,,Business decision,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,INDUSTRY,,,,,,,2024,0.0
NCT03274804,,2017-08-14,2021-02-01,,2022-05-17,2017-09-04,2017-09-07,ACTUAL,2021-03-23,2021-04-22,ACTUAL,,,,2022-05-17,2022-06-07,ACTUAL,2018-04-01,ACTUAL,2018-04-01,2022-05,2022-05-31,2020-03-01,ACTUAL,2020-03-01,2020-03-01,ACTUAL,2020-03-01,,INTERVENTIONAL,PICCASSO,The required parameters as defined in the inclusion and exclusion criteria are met by all patients.,Combined PD-1 and CCR5 Inhibition for the Treatment of Refractory Microsatellite Stable mCRC,A Phase I Trial of Combined PD-1 Inhibition (Pembrolizumab) and CCR5 Inhibition (Maraviroc) for the Treatment of Refractory Microsatellite Stable (MSS) Metastatic Colorectal Cancer (mCRC),COMPLETED,,PHASE1,20.0,ACTUAL,University Hospital Heidelberg,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,OTHER,,,,,,,2020,1.0
NCT05463744,,2022-07-15,,,2024-07-26,2022-07-15,2022-07-19,ACTUAL,,,,,,,2024-07-26,2024-07-29,ACTUAL,2022-08-12,ACTUAL,2022-08-12,2024-05,2024-05-31,2024-05-07,ACTUAL,2024-05-07,2024-05-07,ACTUAL,2024-05-07,,INTERVENTIONAL,QWINT-5,,A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy,"A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy",COMPLETED,,PHASE3,692.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,INDUSTRY,,,,,,,2024,1.0
NCT03562416,,2018-05-07,,,2023-04-05,2018-06-07,2018-06-19,ACTUAL,,,,,,,2023-04-05,2023-04-07,ACTUAL,2019-07-05,ACTUAL,2019-07-05,2023-04,2023-04-30,2021-12-21,ACTUAL,2021-12-21,2021-12-21,ACTUAL,2021-12-21,,INTERVENTIONAL,,,Continuation of Nintedanib After Single Lung Transplantation in IPF Subjects,Nintedanib Plus Usual Transplant Care Compared to Usual Transplant Care Alone After Single Lung Transplantation in Patients With Idiopathic Pulmonary Fibrosis: a Pilot Randomized Controlled Trial,TERMINATED,,PHASE2,1.0,ACTUAL,Temple University,,2.0,,Low enrollment,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,OTHER,,,,,,,2021,0.0
NCT05425732,,2022-06-15,2024-05-10,,2024-09-10,2022-06-15,2022-06-21,ACTUAL,2024-05-10,2024-06-10,ACTUAL,,,,2024-09-10,2024-10-01,ACTUAL,2022-07-13,ACTUAL,2022-07-13,2024-09,2024-09-30,2023-05-18,ACTUAL,2023-05-18,2023-05-18,ACTUAL,2023-05-18,,INTERVENTIONAL,,All vaccinated participants. Includes two participants from Cohort 1 who had unplanned vaccinations with both V116 and PCV20,"Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)","A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults",COMPLETED,,PHASE3,2663.0,ACTUAL,Merck Sharp & Dohme LLC,,4.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,INDUSTRY,,,,,,,2023,1.0
NCT01506141,,2011-12-15,,,2024-05-06,2012-01-06,2012-01-09,ESTIMATED,,,,,,,2024-05-06,2024-05-07,ACTUAL,2010-08-01,ACTUAL,2010-08-01,2024-05,2024-05-31,2024-04-30,ACTUAL,2024-04-30,2024-04-30,ACTUAL,2024-04-30,,INTERVENTIONAL,,,An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment,An Open-Label Extension of Study HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Intrathecal Idursulfase-IT Administered in Conjunction With Intravenous Elaprase® in Pediatric Patients With Hunter Syndrome and Cognitive Impairment,COMPLETED,,PHASE1/PHASE2,25.0,ACTUAL,Takeda,,1.0,,,f,,,,f,t,f,,,t,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,INDUSTRY,,,,,,,2024,1.0
NCT04370379,,2020-04-24,,,2021-11-10,2020-04-29,2020-04-30,ACTUAL,,,,,,,2021-11-10,2021-11-11,ACTUAL,2020-05-28,ACTUAL,2020-05-28,2021-11,2021-11-30,2021-05-08,ACTUAL,2021-05-08,2021-04-30,ACTUAL,2021-04-30,,INTERVENTIONAL,,,Trial to Evaluate the Safety and Tolerability of Repeated Intravitreal Injection of IBI302 in Neovascular AMD Patients,A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI302 in Patients With Neovascular Age-related Macular Degeneration (nAMD),COMPLETED,,PHASE1,18.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,3.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,INDUSTRY,,,,,,,2021,1.0
NCT05007977,,2021-07-20,,,2023-07-11,2021-08-16,2021-08-17,ACTUAL,,,,,,,2023-07-11,2023-07-12,ACTUAL,2021-07-08,ACTUAL,2021-07-08,2023-07,2023-07-31,2022-04-18,ACTUAL,2022-04-18,2022-04-12,ACTUAL,2022-04-12,,INTERVENTIONAL,,,Effect of ZT-01 on Glucagon During Hypoglycemia in Type 1 Diabetes Mellitus,Pharmacodynamic Evaluation of ZT-01 in a Stepped Hypoglycemic Clamp Model in Subjects With Type 1 Diabetes Mellitus,TERMINATED,,PHASE1,24.0,ACTUAL,Zucara Therapeutics Inc.,,6.0,,The study was completed following review of the assumptions underlying the power calculation and it was deemed that enough subjects had been recruited to complete enrollment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,INDUSTRY,,,,,,,2022,0.0
NCT03962725,,2019-05-21,,,2023-01-31,2019-05-23,2019-05-24,ACTUAL,,,,,,,2023-01-31,2023-02-02,ACTUAL,2019-08-07,ACTUAL,2019-08-07,2023-01,2023-01-31,2022-12-19,ACTUAL,2022-12-19,2022-12-19,ACTUAL,2022-12-19,,INTERVENTIONAL,,,Avoiding Neuromuscular Blockers to Reduce Complications,"Eliminating Use of Non Depolarizing Neuromuscular Blocking Agents to Reduce Postoperative Pulmonary Complications: A Multi-center, Randomized Control Trial",TERMINATED,,PHASE4,3.0,ACTUAL,Beth Israel Deaconess Medical Center,,2.0,,Study terminated due to lack of enrollment.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,OTHER,,,,,,,2022,0.0
NCT04737109,,2021-01-29,2023-03-28,,2023-10-23,2021-02-02,2021-02-03,ACTUAL,2023-10-23,2023-11-13,ACTUAL,,,,2023-10-23,2023-11-13,ACTUAL,2021-07-13,ACTUAL,2021-07-13,2023-10,2023-10-31,2022-08-15,ACTUAL,2022-08-15,2022-08-15,ACTUAL,2022-08-15,,INTERVENTIONAL,ADDItion,,"Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer","A Single Arm, Phase I/II Trial of Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer Big Ten Cancer Research Consortium BTCRC-GU19-404",TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,Big Ten Cancer Research Consortium,,2.0,,Funder Decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,OTHER,,,,,,,2022,0.0
NCT03426254,,2018-01-27,,,2023-03-27,2018-02-07,2018-02-08,ACTUAL,,,,,,,2023-03-27,2023-03-29,ACTUAL,2022-11-10,ESTIMATED,2022-11-10,2023-03,2023-03-31,2024-01-10,ESTIMATED,2024-01-10,2023-12-10,ESTIMATED,2023-12-10,,INTERVENTIONAL,,,Comparison of Safety and Clinical Benefit of Injections Subcutaneously Talazoparib Versus Oral Talazoparib in Patients With Solid Tumors,Comparison of Safety and Clinical Benefit of Injections Subcutaneously Talazoparib Versus Oral Talazoparib in Patients With Advanced Solid Tumors ( Phase I ),WITHDRAWN,,PHASE1,0.0,ACTUAL,Center Trials & Treatment,,2.0,,the company is liquidated,f,,,,f,f,f,,,,,,,,,,,2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,OTHER,,,,,,,2024,0.0
NCT04474314,,2020-06-26,2022-06-08,,2023-10-17,2020-07-15,2020-07-16,ACTUAL,2023-10-17,2023-10-18,ACTUAL,,,,2023-10-17,2023-10-18,ACTUAL,2020-08-13,ACTUAL,2020-08-13,2022-07,2022-07-31,2022-05-04,ACTUAL,2022-05-04,2022-03-02,ACTUAL,2022-03-02,,INTERVENTIONAL,,Intent to Treat Analysis set,A Study of IMR-687 in Subjects With Sickle Cell Disease,A Phase 2b Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects With Sickle Cell Disease,TERMINATED,,PHASE2,115.0,ACTUAL,"Imara, Inc.",,3.0,,"A recently conducted Interim analysis of IMR-SCD-301 demonstrated that while IMR-687 was generally well-tolerated, it failed to meet its primary efficacy endpoint. So, the sponsor has decided to discontinue this study.",,,,,t,t,f,,,,,,,,,,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,INDUSTRY,,,,,,,2022,0.0
NCT04594213,,2020-10-13,2024-04-11,2022-04-12,2024-04-11,2020-10-13,2020-10-20,ACTUAL,2024-04-11,2024-05-08,ACTUAL,2022-04-12,2022-04-15,ACTUAL,2024-04-11,2024-05-08,ACTUAL,2020-09-23,ACTUAL,2020-09-23,2024-04,2024-04-30,2022-05-09,ACTUAL,2022-05-09,2021-04-15,ACTUAL,2021-04-15,,INTERVENTIONAL,ULTRA I,The full analysis set (FAS) included all randomized subjects.,"Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Lateral Canthal Lines) in Subjects With Moderate to Severe Upper Facial Lines","A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)",COMPLETED,,PHASE3,362.0,ACTUAL,"Merz North America, Inc.",,6.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,INDUSTRY,,,,,,,2022,1.0
NCT05835011,,2023-04-18,2024-09-09,,2024-09-09,2023-04-18,2023-04-28,ACTUAL,2024-09-09,2024-10-02,ACTUAL,,,,2024-09-09,2024-10-02,ACTUAL,2023-06-27,ACTUAL,2023-06-27,2024-09,2024-09-30,2023-08-21,ACTUAL,2023-08-21,2023-08-21,ACTUAL,2023-08-21,,INTERVENTIONAL,,"The study was terminated by the Sponsor. Based on the low enrollment number (n=2), no data, except region of enrollment, is reported here to protect and maintain participant privacy/confidentiality.",A Study of Oral Decitabine/Cedazuridine in Combination With Magrolimab in Participants With Intermediate- to Very High-Risk Myelodysplastic Syndromes (MDS),A Phase 2 Study of Oral Decitabine/Cedazuridine in Combination With Magrolimab for Previously Untreated Subjects With Intermediate- to Very High-Risk Myelodysplastic Syndromes (MDS),TERMINATED,,PHASE2,2.0,ACTUAL,"Astex Pharmaceuticals, Inc.",The study was terminated prematurely due to discontinuation of magrolimab development in MDS.,1.0,,Termination due to discontinuation of magrolimab development in MDS.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,INDUSTRY,,,,,,,2023,0.0
NCT06153186,,2019-10-29,,,2023-11-29,2023-11-29,2023-12-01,ACTUAL,,,,,,,2023-11-29,2023-12-01,ACTUAL,2019-09-20,ACTUAL,2019-09-20,2023-11,2023-11-30,2023-05-26,ACTUAL,2023-05-26,2023-05-26,ACTUAL,2023-05-26,,INTERVENTIONAL,,,Flunarizine for Treatment Resistant Absence Epilepsy,Flunarizine for Treatment Resistant Absence Epilepsy,TERMINATED,,PHASE2,9.0,ACTUAL,University of British Columbia,,1.0,,The enrollment wasn't as predicted. We didn't have enough numbers to show statistical significance.,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,OTHER,,,,,,,2023,0.0
NCT04042727,,2019-07-31,2024-04-10,,2024-06-01,2019-07-31,2019-08-02,ACTUAL,2024-06-01,2024-06-04,ACTUAL,,,,2024-06-01,2024-06-04,ACTUAL,2019-08-21,ACTUAL,2019-08-21,2024-06,2024-06-30,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,C-RAD,,Controlling Rapid Atrial Fibrillation With Dexmedetomidine,Controlling Rapid Atrial Fibrillation With Dexmedetomidine (C-RAD) Trial,TERMINATED,,PHASE2/PHASE3,13.0,ACTUAL,Stony Brook University,,2.0,,"Futility, as a result of COVID-19 impact",f,,,,t,t,f,,,t,,,,,,,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,OTHER,,,,,,,2021,0.0
NCT04364009,,2020-04-17,,,2021-01-14,2020-04-24,2020-04-27,ACTUAL,,,,,,,2021-01-14,2021-01-15,ACTUAL,2020-04-27,ACTUAL,2020-04-27,2020-04,2020-04-30,2020-11-03,ACTUAL,2020-11-03,2020-10-20,ACTUAL,2020-10-20,,INTERVENTIONAL,ANACONDA,,Anakinra for COVID-19 Respiratory Symptoms,Efficacy and Safety of ANAkinra During Adult  COVID-19  With Aggravating Respiratory Symptoms: a Multicenter Open-label Controlled Randomized Trial,TERMINATED,,PHASE3,71.0,ACTUAL,"University Hospital, Tours",,2.0,,Efficiency and safety reasons,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,OTHER,,,,,,,2020,0.0
NCT04005079,,2019-06-28,,,2022-04-06,2019-06-28,2019-07-02,ACTUAL,,,,,,,2022-04-06,2022-04-07,ACTUAL,2019-06-05,ACTUAL,2019-06-05,2022-04,2022-04-30,2021-01-21,ACTUAL,2021-01-21,2021-01-21,ACTUAL,2021-01-21,,INTERVENTIONAL,PACCT,,Pilocarpine After Combined Cataract/Trabectome Surgery,A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Trabectome Surgery,WITHDRAWN,,PHASE3,0.0,ACTUAL,Montefiore Medical Center,,2.0,,not performing Trabectomes,f,,,,,t,f,,,t,,,,,,NO,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,OTHER,,,,,,,2021,0.0
NCT04740034,,2021-02-01,,,2024-09-30,2021-02-01,2021-02-05,ACTUAL,,,,,,,2024-09-30,2024-10-01,ACTUAL,2021-04-29,ACTUAL,2021-04-29,2024-09,2024-09-30,2024-06-24,ACTUAL,2024-06-24,2024-06-24,ACTUAL,2024-06-24,,INTERVENTIONAL,,,A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma,"A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of AMG 340, a Bispecific Antibody Targeting PSMA in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma",COMPLETED,,PHASE1,42.0,ACTUAL,Amgen,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,INDUSTRY,,,,,,,2024,0.0
NCT02901275,,2016-07-28,2021-03-30,,2023-11-01,2016-09-09,2016-09-15,ESTIMATED,2021-05-11,2021-06-07,ACTUAL,,,,2023-11-01,2023-11-07,ACTUAL,2016-12,ACTUAL,2016-12-31,2023-11,2023-11-30,2020-03-23,ACTUAL,2020-03-23,2020-03-23,ACTUAL,2020-03-23,,INTERVENTIONAL,,,Enhancing Medication-based Analgesia in Humans,Using Dronabinol to Enhance the Analgesic Effect of Hydromorphone in Humans,COMPLETED,,PHASE2,29.0,ACTUAL,Johns Hopkins University,,5.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,OTHER,,,,,,,2020,1.0
NCT03296033,,2017-07-06,2023-03-09,,2023-09-08,2017-09-26,2017-09-28,ACTUAL,2023-09-08,2023-10-05,ACTUAL,,,,2023-09-08,2023-10-05,ACTUAL,2017-10-24,ACTUAL,2017-10-24,2023-09,2023-09-30,2022-01-14,ACTUAL,2022-01-14,2022-01-14,ACTUAL,2022-01-14,,INTERVENTIONAL,,Baseline characteristics only collected for subjects who completed,Residual Anti-Xa Activity After Last Treatment Dose of Enoxaparin,Evaluation of Residual Anti-Xa Activity As A Function Of Time Following The Last Treatment Dose of Enoxaparin In Patients Presenting For Elective Surgery,TERMINATED,,PHASE4,122.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,enrollment proved to be a challenge due to the changing of the guidelines for bridging off the new anticoagulants that are being prescribed,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,OTHER,,,,,,,2022,0.0
NCT05098509,,2021-09-22,2023-09-06,,2023-09-26,2021-10-18,2021-10-28,ACTUAL,2023-09-26,2023-10-19,ACTUAL,,,,2023-09-26,2023-10-19,ACTUAL,2022-04-13,ACTUAL,2022-04-13,2023-09,2023-09-30,2022-10-31,ACTUAL,2022-10-31,2022-10-06,ACTUAL,2022-10-06,,INTERVENTIONAL,,"The Intent to Treat (ITT) Population included all randomized participants who received at least 1 dose of study drug. Due to the small sample size, data was not reported for confidentiality reasons.",A Study to Assess RAD011 (Cannabidiol Oral Solution) for the Treatment of Participants With Prader-Willi Syndrome,"A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients With Prader- Willi Syndrome",TERMINATED,,PHASE2/PHASE3,4.0,ACTUAL,"Radius Pharmaceuticals, Inc.","The study has been voluntarily terminated by the sponsor due to change in corporate priorities, for reasons other than safety. Due to early termination of study, no efficacy analyses were done.",4.0,,"Due to a change in corporate priorities, this study was voluntarily terminated by the Sponsor for reasons other than safety",f,,,,t,t,f,,,,,,,,,,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,INDUSTRY,,,,,,,2022,0.0
NCT03225833,,2017-07-17,2021-12-17,,2022-02-09,2017-07-20,2017-07-21,ACTUAL,2022-02-09,2022-02-10,ACTUAL,,,,2022-02-09,2022-02-10,ACTUAL,2017-07-17,ACTUAL,2017-07-17,2022-02,2022-02-28,2021-05-11,ACTUAL,2021-05-11,2021-05-11,ACTUAL,2021-05-11,,INTERVENTIONAL,PRECISION-HD1,,Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease,"A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120101 Administered Intrathecally in Patients With Huntington's Disease",TERMINATED,,PHASE1/PHASE2,61.0,ACTUAL,Wave Life Sciences Ltd.,,5.0,,Lack of Efficacy,f,,,,t,f,f,,,,,,,,,,,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,INDUSTRY,,,,,,,2021,0.0
NCT03852979,,2017-12-05,,,2020-01-07,2019-02-21,2019-02-25,ACTUAL,,,,,,,2020-01-07,2020-01-10,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2018-12,2018-12-31,2020-01-01,ACTUAL,2020-01-01,2020-01-01,ACTUAL,2020-01-01,,INTERVENTIONAL,NEOCON-F,,Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility,Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility,TERMINATED,,PHASE2,1.0,ACTUAL,The Netherlands Cancer Institute,,1.0,,study is merged with CONTESSA study,f,,,,f,f,f,,,,,,,,,UNDECIDED,to be determined,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,OTHER,,,,,,,2020,0.0
NCT04536181,,2020-08-26,,,2020-12-14,2020-08-28,2020-09-02,ACTUAL,,,,,,,2020-12-14,2020-12-17,ACTUAL,2021-01-01,ESTIMATED,2021-01-01,2020-12,2020-12-31,2022-10-01,ESTIMATED,2022-10-01,2022-09-01,ESTIMATED,2022-09-01,,INTERVENTIONAL,,,Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome,"Comparative Study of 3 or 6 Months Initial Steroid Treatment in Children Under 6 Years of Age With Steroid Sensitive Nephrotic Syndrome：a Randomized, Double-blind, Placebo-controlled Study",WITHDRAWN,,PHASE3,0.0,ACTUAL,Children's Hospital of Fudan University,,2.0,,lack of funding,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,OTHER,,,,,,,2022,0.0
NCT03301467,,2017-09-22,2022-05-19,,2024-05-01,2017-09-29,2017-10-04,ACTUAL,2022-10-12,2022-10-14,ACTUAL,,,,2024-05-01,2024-05-03,ACTUAL,2017-09-29,ACTUAL,2017-09-29,2024-05,2024-05-31,2021-10-27,ACTUAL,2021-10-27,2021-03-03,ACTUAL,2021-03-03,,INTERVENTIONAL,ACCOLADE,,Controlled Trial Evaluating Avacopan in C3 Glomerulopathy,"A Randomized, Double Blind, Placebo Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients With C3 Glomerulopathy",COMPLETED,,PHASE2,57.0,ACTUAL,ChemoCentryx,,2.0,,,,,,,t,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,INDUSTRY,,,,,,,2021,1.0
NCT04405245,,2020-05-23,2022-09-21,,2023-05-01,2020-05-23,2020-05-28,ACTUAL,2023-05-01,2023-05-25,ACTUAL,,,,2023-05-01,2023-05-25,ACTUAL,2020-06-06,ACTUAL,2020-06-06,2023-05,2023-05-31,2020-11-05,ACTUAL,2020-11-05,2020-11-05,ACTUAL,2020-11-05,,INTERVENTIONAL,,Each Baseline participant contributed one study eye and one fellow eye,"Study to Assess the Efficacy, Safety and Tolerability of AKB-9778 Ophthalmic Solution as and Adjunct to Latanoprost in Patients With Ocular Hypertension or Open Angle Glaucoma","Phase 2 Multi-Center, Double-Masked, Randomized, 28-Day Study to Assess the Efficacy, Safety and Tolerability of Single or Twice Daily Doses of AKB-9778 Ophthalmic Solution as an Adjunct to Latanoprost in Patients With Ocular Hypertension (OHT) or Open Angle Glaucoma (OAG)",COMPLETED,,PHASE2,194.0,ACTUAL,"EyePoint Pharmaceuticals, Inc.",,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,INDUSTRY,,,,,Eyes,,2020,1.0
NCT04732949,,2021-01-28,2022-12-15,,2023-03-24,2021-01-29,2021-02-01,ACTUAL,2023-03-24,2023-03-27,ACTUAL,,,,2023-03-24,2023-03-27,ACTUAL,2021-01-12,ACTUAL,2021-01-12,2021-01,2021-01-31,2022-02-10,ACTUAL,2022-02-10,2021-12-15,ACTUAL,2021-12-15,,INTERVENTIONAL,SPRINTER,The Intent-to-Treat (ITT) analysis population consisted of all randomised patients.,Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19,"A Randomised, Double-blind, Placebo-controlled, Phase III Trial to Determine the Efficacy and Safety of Inhaled SNG001 for the Treatment of Patients Hospitalised Due to Moderate COVID-19",COMPLETED,,PHASE3,623.0,ACTUAL,Synairgen Research Ltd.,,2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,INDUSTRY,,,,,,,2022,1.0
NCT04079881,,2019-08-29,2021-07-01,,2022-09-13,2019-09-03,2019-09-06,ACTUAL,2022-02-04,2022-03-02,ACTUAL,,,,2022-09-13,2022-10-07,ACTUAL,2020-02-13,ACTUAL,2020-02-13,2022-09,2022-09-30,2020-07-01,ACTUAL,2020-07-01,2020-07-01,ACTUAL,2020-07-01,,INTERVENTIONAL,,Trial was terminated due to COVID pandemic and loss of funding.,Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes,Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes,TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,Washington University School of Medicine,Study was terminated before completion due to COVID pandemic and loss of funding.,2.0,,Loss of funding,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,OTHER,,,,,,,2020,0.0
NCT03957876,,2019-04-10,2024-03-15,,2024-08-14,2019-05-20,2019-05-21,ACTUAL,2024-08-14,2024-08-15,ACTUAL,,,,2024-08-14,2024-08-15,ACTUAL,2019-07-25,ACTUAL,2019-07-25,2024-08,2024-08-31,2022-12-20,ACTUAL,2022-12-20,2022-12-20,ACTUAL,2022-12-20,,INTERVENTIONAL,,,CPX-351 Therapy for MDS After Hypomethylating Agent Failure,A Phase II Study of CPX-351 as a Novel Therapeutic Approach for Patients With Myelodysplastic Syndromes (MDS) After Hypomethylating Agent Failure,TERMINATED,,PHASE2,4.0,ACTUAL,Case Comprehensive Cancer Center,Early termination led to a small number of subjects analyzed.,1.0,,Slow Accrual,f,,,,t,t,f,,,,,,,,,NO,The study team does not plan to share IPD collected in this study,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,OTHER,,,,,,,2022,0.0
NCT04725812,,2021-01-19,2023-08-14,,2023-11-10,2021-01-21,2021-01-27,ACTUAL,2023-11-10,2023-11-29,ACTUAL,,,,2023-11-10,2023-11-29,ACTUAL,2021-09-13,ACTUAL,2021-09-13,2023-11,2023-11-30,2021-12-07,ACTUAL,2021-12-07,2021-12-07,ACTUAL,2021-12-07,,INTERVENTIONAL,CRUSH,,Complement Regulation to Undo Systemic Harm in Preeclampsia,Complement Regulation to Undo Systemic Harm in Preeclampsia: The CRUSH Study,TERMINATED,,PHASE2,2.0,ACTUAL,Cedars-Sinai Medical Center,"The PI, Dr. Richard Burwick left the institution where this research was being conducted in April 2022 and study activity halted at that time. Two subjects were consented to participate in the study and one withdrew participation before study procedures were completed. Study Funding was terminated by Sponsor.~Dr. Karumanchi is a co-investigator in this study who has been named as the Responsible Party within the PRS system solely for the purpose of reporting the results.",1.0,,PI moved institutions,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,OTHER,,,,,,,2021,0.0
NCT03486457,,2018-03-05,2022-03-08,,2023-06-03,2018-03-30,2018-04-03,ACTUAL,2023-06-03,2024-02-08,ACTUAL,,,,2023-06-03,2024-02-08,ACTUAL,2018-08-10,ACTUAL,2018-08-10,2023-06,2023-06-30,2021-04-28,ACTUAL,2021-04-28,2021-04-28,ACTUAL,2021-04-28,,INTERVENTIONAL,,Safety analysis set: included all participants who received at least one dose of the study drug (tofacitinib or placebo),Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis,"A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB (CP-690,550) IN CHINESE SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS AND AN INADEQUATE RESPONSE TO AT LEAST ONE CONVENTIONAL SYNTHETIC DMARD",COMPLETED,,PHASE3,204.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,f,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,INDUSTRY,,,,,,,2021,1.0
NCT05148234,,2021-12-04,2024-02-13,,2024-05-17,2021-12-07,2021-12-08,ACTUAL,2024-05-17,2024-06-11,ACTUAL,,,,2024-05-17,2024-06-11,ACTUAL,2022-11-29,ACTUAL,2022-11-29,2024-05,2024-05-31,2023-07-03,ACTUAL,2023-07-03,2023-02-02,ACTUAL,2023-02-02,,INTERVENTIONAL,,Data was collected and reported for one participant enrolled but not treated.,BMS-986253 in Myelodysplastic Syndromes,A Phase I/II Trial of BMS-986253 in Myelodysplastic Syndromes,TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,National Institutes of Health Clinical Center (CC),,4.0,,Company closed the trial.,f,,,,f,t,f,,,,,,Data from this study may be requested from other researchers after the completion of the primary endpoint. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.,Data from this study may be requested by contacting the principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.,,YES,"All collected individual participant data (IPD) will be shared. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).",2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,NIH,,,,,,,2023,0.0
NCT03472690,,2018-03-08,,,2021-05-14,2018-03-13,2018-03-21,ACTUAL,,,,,,,2021-05-14,2021-05-18,ACTUAL,2018-06-25,ACTUAL,2018-06-25,2021-05,2021-05-31,2021-02-25,ACTUAL,2021-02-25,2020-12-20,ACTUAL,2020-12-20,,INTERVENTIONAL,,,QBECO SSI for Clinical and Endoscopic Remission in Moderate to Severe Crohn's Disease,"A Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of QBECO SSI for the Induction and Maintenance of Clinical and Endoscopic Remission in Subjects With Moderate to Severe Crohn's Disease",TERMINATED,,PHASE2,20.0,ACTUAL,Qu Biologics Inc.,,2.0,,Corporate Decision to terminate study after Lead-In portion of the study completed.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,INDUSTRY,,,,,,,2021,0.0
NCT03749447,,2018-11-19,2024-02-20,,2024-02-20,2018-11-20,2018-11-21,ACTUAL,2024-02-20,2024-03-19,ACTUAL,,,,2024-02-20,2024-03-19,ACTUAL,2019-03-08,ACTUAL,2019-03-08,2024-02,2024-02-29,2023-08-23,ACTUAL,2023-08-23,2023-08-23,ACTUAL,2023-08-23,,INTERVENTIONAL,EAGLE,The safety population included all participants who had received at least 1 dose of bardoxolone methyl in the 402-C-1803 study.,An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE),An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease,TERMINATED,,PHASE3,270.0,ACTUAL,Biogen,Early termination of trial due to discontinuation of all bardoxolone chronic kidney disease programs.,1.0,,Discontinuation of all bardoxolone chronic kidney disease programs,f,,,,f,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,INDUSTRY,,,,,,,2023,0.0
NCT04033328,,2019-07-24,,,2023-12-11,2019-07-24,2019-07-26,ACTUAL,,,,,,,2023-12-11,2023-12-15,ACTUAL,2019-10-28,ACTUAL,2019-10-28,2023-12,2023-12-31,2023-12-04,ACTUAL,2023-12-04,2022-11-22,ACTUAL,2022-11-22,,INTERVENTIONAL,,,Study of ORIC-101 in Combination With Enzalutamide,An Open-Label Phase 1b Study of ORIC-101 in Combination With Enzalutamide in Patients With Metastatic Prostate Cancer Progressing on Enzalutamide,TERMINATED,,PHASE1,41.0,ACTUAL,ORIC Pharmaceuticals,,2.0,,IND Withdrawn,,,,,f,t,f,,,,,,,,,,,2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,INDUSTRY,,,,,,,2023,0.0
NCT04634825,,2020-11-12,2023-05-30,,2023-12-18,2020-11-12,2020-11-18,ACTUAL,2023-12-18,2023-12-20,ACTUAL,,,,2023-12-18,2023-12-20,ACTUAL,2021-03-17,ACTUAL,2021-03-17,2023-12,2023-12-31,2022-07-29,ACTUAL,2022-07-29,2022-07-29,ACTUAL,2022-07-29,,INTERVENTIONAL,,,Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer,A Phase 2 Open-Label Trial to Evaluate Enoblituzumab in Combination With Retifanlimab or Tebotelimab in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck,TERMINATED,,PHASE2,62.0,ACTUAL,MacroGenics,,2.0,,Based on internal review of safety data,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,INDUSTRY,,,,,,,2022,0.0
NCT03563365,,2018-05-23,,,2021-04-20,2018-06-08,2018-06-20,ACTUAL,,,,,,,2021-04-20,2021-04-23,ACTUAL,2018-06-04,ACTUAL,2018-06-04,2021-04,2021-04-30,2021-03-02,ACTUAL,2021-03-02,2021-03-02,ACTUAL,2021-03-02,,INTERVENTIONAL,,,The Functional and Emotional Benefits of Replenix Power of Three With Resveratrol,"A Randomized, Investigator Blinded, Single Site, Three Arm Clinical Study to Assess the Functional and Emotional Benefits of Replenix Power of Three Cream With Resveratrol , Replenix Power of Three Cream With Resveratrol With Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, and Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, Utilized to Treat Subjects With Facial Acne Vulgaris",TERMINATED,,PHASE4,43.0,ACTUAL,Yardley Dermatology Associates,,3.0,,Lack of Funding,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,OTHER,,,,,,,2021,0.0
NCT03560258,,2018-06-06,2022-02-08,,2022-03-28,2018-06-06,2018-06-18,ACTUAL,2022-03-28,2022-04-26,ACTUAL,,,,2022-03-28,2022-04-26,ACTUAL,2019-03-26,ACTUAL,2019-03-26,2022-03,2022-03-31,2021-02-10,ACTUAL,2021-02-10,2021-02-10,ACTUAL,2021-02-10,,INTERVENTIONAL,,Participants who received at least one study treatment dose.,HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) Vaccine Study,HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) as Therapeutic Vaccination in HIV-Infected Persons With Viral Suppression on Antiretroviral Therapy,COMPLETED,,PHASE1/PHASE2,45.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,3.0,,,f,,,,t,t,f,,,,,,Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.,* With whom?~  * Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses?~  * To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism will data be made available?~  * Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.,,YES,"Individual participant data that underlie results in the publication, after deidentification.",2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,NIH,,,,,,,2021,1.0
NCT05321251,,2022-04-01,,,2024-02-01,2022-04-01,2022-04-11,ACTUAL,,,,,,,2024-02-01,2024-02-05,ACTUAL,2022-06-01,ACTUAL,2022-06-01,2024-02,2024-02-29,2023-10-18,ACTUAL,2023-10-18,2023-10-18,ACTUAL,2023-10-18,,INTERVENTIONAL,,,Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.,Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,University of Alberta,,2.0,,Study never commenced due to logistical issues.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,OTHER,,,,,,,2023,0.0
NCT03593421,,2018-06-07,,,2018-12-31,2018-07-09,2018-07-20,ACTUAL,,,,,,,2018-12-31,2019-01-03,ACTUAL,2019-02-01,ESTIMATED,2019-02-01,2018-12,2018-12-31,2020-12-31,ESTIMATED,2020-12-31,2020-12-01,ESTIMATED,2020-12-01,,INTERVENTIONAL,,,Phase 2 Dose Finding sPIF in Patients With High Panel Reactive Antibodies,"Phase II, Open Label Adaptive Design Dose Finding Study to Investigate Effect of Synthetic PreImplantation Factor (sPIF) in Patients With High Panel Reactive Antibodies",WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Miami,,5.0,,BioInceptdecided not to pursue this drug target at this time.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,OTHER,,,,,,,2020,0.0
NCT04487912,,2020-07-22,,,2021-05-12,2020-07-24,2020-07-27,ACTUAL,,,,,,,2021-05-12,2021-05-14,ACTUAL,2020-11-24,ACTUAL,2020-11-24,2020-06,2020-06-30,2021-05-01,ACTUAL,2021-05-01,2021-05-01,ACTUAL,2021-05-01,,INTERVENTIONAL,,,Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer,Dynamics and Tracer Distribution of Tilmanocept Using Combined Subareolar and Peritumoral Injection Technique for Scintigraphic Sentinel Lymph Node Detection in Early Stage Breast Cancer,WITHDRAWN,,PHASE4,0.0,ACTUAL,"University Hospital, Ghent",,2.0,,Insufficient patient inclusion,f,,,,,f,f,,,f,,,,,,NO,,2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,OTHER,,,,,,,2021,0.0
NCT04483505,,2020-07-20,,,2023-12-27,2020-07-22,2020-07-23,ACTUAL,,,,,,,2023-12-27,2023-12-28,ACTUAL,2020-11-25,ACTUAL,2020-11-25,2023-12,2023-12-31,2023-04-04,ACTUAL,2023-04-04,2023-04-04,ACTUAL,2023-04-04,,INTERVENTIONAL,ROGABREAST,,"Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer.","Rogaratinib, Palbociclib and Fulvestrant in Advanced Hormone Receptor Positive, FGFR1/2/3-positive Breast Cancer: Phase I Clinical Trial Plus an Expansion Cohort",COMPLETED,,PHASE1,9.0,ACTUAL,Fundacion CRIS de Investigación para Vencer el Cáncer,,1.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,OTHER,,,,,,,2023,1.0
NCT05104567,,2021-10-21,,2024-07-24,2024-10-01,2021-10-21,2021-11-03,ACTUAL,,,,,2024-03-28,ACTUAL,2024-10-01,2024-10-02,ACTUAL,2021-12-09,ACTUAL,2021-12-09,2024-10,2024-10-31,2024-09-09,ACTUAL,2024-09-09,2023-07-26,ACTUAL,2023-07-26,,INTERVENTIONAL,,,A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203),"A Phase 2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR-707) Combined With Other Anticancer Therapies for the Treatment of Participants With Advanced and Metastatic Gastrointestinal Cancer",TERMINATED,,PHASE2,138.0,ACTUAL,Sanofi,,7.0,,Early discontinuation based on strategic sponsor decision not driven by any safety concerns.,f,,,,t,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,INDUSTRY,,,,,,,2024,0.0
NCT03511222,,2018-04-18,,,2020-07-27,2018-04-18,2018-04-27,ACTUAL,,,,,,,2020-07-27,2020-07-29,ACTUAL,2018-09-11,ACTUAL,2018-09-11,2020-07,2020-07-31,2020-05-28,ACTUAL,2020-05-28,2019-08-15,ACTUAL,2019-08-15,,INTERVENTIONAL,,,Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors,A Phase IB Trial of Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors,TERMINATED,,PHASE1,16.0,ACTUAL,Washington University School of Medicine,,3.0,,Low accrual,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 10:52:54.134897,2024-10-16 10:52:54.134897,OTHER,,,,,,,2020,0.0
NCT03618654,,2018-08-01,,,2024-03-11,2018-08-01,2018-08-07,ACTUAL,,,,,,,2024-03-11,2024-03-13,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2024-03,2024-03-31,2022-12-07,ACTUAL,2022-12-07,2021-11-20,ACTUAL,2021-11-20,,INTERVENTIONAL,,,Durvalumab With or Without Metformin in Treating Participants With Head and Neck Squamous Cell Carcinoma,Window of Opportunity for Durvalumab (MEDI4736) Plus Metformin Trial of in Squamous Cell Carcinoma of the Head and Neck,COMPLETED,,EARLY_PHASE1,38.0,ACTUAL,Thomas Jefferson University,,2.0,,,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,OTHER,,,,,,,2022,1.0
NCT03660553,,2018-09-04,2023-07-18,,2023-11-20,2018-09-04,2018-09-06,ACTUAL,2023-11-20,2023-12-12,ACTUAL,,,,2023-11-20,2023-12-12,ACTUAL,2018-10-10,ACTUAL,2018-10-10,2023-11,2023-11-30,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,,Simplified Insulin Regimen for the Elderly,Effect of Simplified Insulin Regimen on Glycemic Control and Quality of Life in an Elderly Population With Type 2 Diabetes,TERMINATED,,PHASE4,7.0,ACTUAL,University of Miami,This study was terminated and there was insufficient patient data for statistical analysis.,2.0,,PI left University of Miami,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 01:20:43.802286,2024-10-16 01:20:43.802286,OTHER,,,,,,,2022,0.0
NCT02728531,,2016-03-30,,,2023-10-31,2016-03-30,2016-04-05,ESTIMATED,,,,,,,2023-10-31,2023-11-01,ACTUAL,2016-04-18,ACTUAL,2016-04-18,2023-10,2023-10-31,2023-08-16,ACTUAL,2023-08-16,2019-01-16,ACTUAL,2019-01-16,,INTERVENTIONAL,,,Bendamustine and Rituximab Alternating With Cytarabine and Rituximab for Untreated Mantle Cell Lymphoma,A Pilot Study of Bendamustine and Rituximab Alternating With Cytarabine and Rituximab for Untreated Mantle Cell Lymphoma,COMPLETED,,PHASE1,18.0,ACTUAL,Washington University School of Medicine,,1.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,OTHER,,,,,,,2023,1.0
NCT01246752,,2010-11-22,,,2021-10-28,2010-11-22,2010-11-23,ESTIMATED,,,,,,,2021-10-28,2021-10-29,ACTUAL,2011-02-10,ACTUAL,2011-02-10,2021-10,2021-10-31,2020-04-30,ACTUAL,2020-04-30,2020-04-30,ACTUAL,2020-04-30,,INTERVENTIONAL,AML,,Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk) </= 60y. After First CR,Randomised Trial on Allogeneic Haematopoietic Stem Cell Transplantation in Patients Under the Age of 60 Years With Acute Myeloid Leukemia of Intermediate Risk in First Complete Remission and a Matched Sibling or Unrelated Donor (ETAL-1),TERMINATED,,PHASE3,143.0,ACTUAL,University Hospital Carl Gustav Carus,,2.0,,decreased recrucial rate as the likelihood of achieving the envisioned patient number in a realistic time-frame was very low.,f,,,,t,,,,,,,,,,,,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,OTHER,,,,,,,2020,0.0
NCT00712582,,2008-07-08,2022-01-21,,2022-05-23,2008-07-08,2008-07-10,ESTIMATED,2022-05-23,2022-06-21,ACTUAL,,,,2022-05-23,2022-06-21,ACTUAL,2008-07-01,ACTUAL,2008-07-01,2021-03,2021-03-31,2021-03-12,ACTUAL,2021-03-12,2021-03-12,ACTUAL,2021-03-12,,INTERVENTIONAL,,,"Therapy for Patients With Untreated Age-Adjusted International Prognostic Index Low-Intermediate Risk, High-Intermediate Risk, or High Risk Diffuse Large B Cell Lymphoma","Risk-Adapted Therapy for Patients With Untreated Age-Adjusted International Prognostic Index Low-Intermediate Risk, High-Intermediate Risk, or High Risk Diffuse Large B Cell Lymphoma",COMPLETED,,PHASE2,96.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,3.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,OTHER,,,,,,,2021,1.0
NCT03430531,,2018-02-06,2022-04-21,,2022-05-20,2018-02-06,2018-02-13,ACTUAL,2022-05-20,2022-06-15,ACTUAL,,,,2022-05-20,2022-06-15,ACTUAL,2019-05-31,ACTUAL,2019-05-31,2022-05,2022-05-31,2022-03-11,ACTUAL,2022-03-11,2020-01-16,ACTUAL,2020-01-16,,INTERVENTIONAL,,,Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache,Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache; A Pilot Study,TERMINATED,,PHASE2,6.0,ACTUAL,Milton S. Hershey Medical Center,The target enrollment was not reached secondary to the COVID-19 pandemic.,1.0,,Study suspended and subsequently terminated due to Pandemic,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,OTHER,,,,,,,2022,0.0
NCT03596450,,2018-07-11,2023-06-09,,2024-06-07,2018-07-11,2018-07-23,ACTUAL,2023-07-21,2023-08-15,ACTUAL,,,,2024-06-07,2024-07-03,ACTUAL,2018-07-13,ACTUAL,2018-07-13,2024-06,2024-06-30,2023-06-09,ACTUAL,2023-06-09,2022-06-09,ACTUAL,2022-06-09,,INTERVENTIONAL,,Full analysis set (FAS) included all randomized participants analyzed according to the treatment group to which they were assigned at randomization.,Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial,Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Clinical Trial,COMPLETED,,PHASE4,1278.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,t,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,INDUSTRY,,,,,,,2023,1.0
NCT05397171,,2022-05-24,2024-06-04,,2024-09-05,2022-05-27,2022-05-31,ACTUAL,2024-09-05,2024-10-01,ACTUAL,,,,2024-09-05,2024-10-01,ACTUAL,2022-06-07,ACTUAL,2022-06-07,2024-09,2024-09-30,2023-06-06,ACTUAL,2023-06-06,2023-06-06,ACTUAL,2023-06-06,,INTERVENTIONAL,,Safety set included all participants who received any amount of investigational product (IP).,A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours,"A Phase I/IIa First-in-human, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours",TERMINATED,,PHASE1/PHASE2,17.0,ACTUAL,AstraZeneca,"This study was terminated early as per protocol Section 4.4, based on overall risk-benefit profile observed to date. No safety concerns reported. Only Sub-study 1 Part A was started; Parts B \& C were not started.",2.0,,"This study was terminated early as per protocol Section 4.4, based on overall risk-benefit profile observed to date. No safety concerns reported. Only Substudy 1 Part A was started; Parts B \& C were not started. Entire Master Protocol was terminated.",f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,INDUSTRY,,,,,,,2023,0.0
NCT03594110,,2018-07-10,2023-06-30,,2024-09-05,2018-07-10,2018-07-20,ACTUAL,2023-06-30,2023-07-27,ACTUAL,,,,2024-09-05,2024-10-01,ACTUAL,2019-01-31,ACTUAL,2019-01-31,2024-09,2024-09-30,2024-07-02,ACTUAL,2024-07-02,2022-07-05,ACTUAL,2022-07-05,,INTERVENTIONAL,,"Randomised set (RS) included all randomised participants, whether treated or not.",EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin),A Multicentre International Randomized Parallel Group Double-blind Placebo-controlled Clinical Trial of EMPAgliflozin Once Daily to Assess Cardio-renal Outcomes in Patients With Chronic KIDNEY Disease,COMPLETED,,PHASE3,6609.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.",2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,INDUSTRY,,,,,,,2024,1.0
NCT03994705,,2019-06-19,,,2024-09-29,2019-06-19,2019-06-21,ACTUAL,,,,,,,2024-09-29,2024-10-01,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2024-09,2024-09-30,2021-06-11,ACTUAL,2021-06-11,2021-05-27,ACTUAL,2021-05-27,,INTERVENTIONAL,,,Descartes-11 in Multiple Myeloma,Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma,TERMINATED,,PHASE1,25.0,ACTUAL,Cartesian Therapeutics,,1.0,,Phase 1 enrollment completed. Further clinical development terminated.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,INDUSTRY,,,,,,,2021,0.0
NCT01608451,,2012-05-22,,,2022-04-26,2012-05-30,2012-05-31,ESTIMATED,,,,,,,2022-04-26,2022-05-02,ACTUAL,2007-09,ACTUAL,2007-09-30,2022-04,2022-04-30,2021-08-20,ACTUAL,2021-08-20,2021-08-20,ACTUAL,2021-08-20,,INTERVENTIONAL,,,Randomized Controlled Trial of Neo-adjuvant Progesterone and Vitamin D3 in Women With Large Operable Breast Cancer and Locally Advanced Breast Cancer,Randomized Controlled Trial of Neo-adjuvant Progesterone and Vitamin D3 in Women With Large Operable Breast Cancer and Locally Advanced Breast Cancer.,TERMINATED,,PHASE3,800.0,ACTUAL,Tata Memorial Hospital,,4.0,,Slow accrual implies that clinical questions being questioned have lost its significance.,f,,,,t,,,,,,,,,,,,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,OTHER_GOV,,,,,,,2021,0.0
NCT04033068,,2019-07-08,2021-10-28,,2021-10-28,2019-07-24,2019-07-25,ACTUAL,2021-10-28,2021-12-06,ACTUAL,,,,2021-10-28,2021-12-06,ACTUAL,2019-08-02,ACTUAL,2019-08-02,2021-10,2021-10-31,2020-06-10,ACTUAL,2020-06-10,2020-01-30,ACTUAL,2020-01-30,,INTERVENTIONAL,MV-ZIKA-RSP,,Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001),"Observer Blinded, Randomized Trial to Evaluate Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP",COMPLETED,,PHASE1,48.0,ACTUAL,Themis Bioscience GmbH,,4.0,,,f,,,,f,f,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,INDUSTRY,,,,,,,2020,1.0
NCT05156632,,2021-12-12,,,2023-02-07,2021-12-13,2021-12-14,ACTUAL,,,,,,,2023-02-07,2023-02-08,ACTUAL,2023-02-20,ESTIMATED,2023-02-20,2023-02,2023-02-28,2023-02-20,ESTIMATED,2023-02-20,2023-02-20,ESTIMATED,2023-02-20,,INTERVENTIONAL,,,"Efficacy,Immunogenicity and Safety of COVID-19 Vaccine , Inactivated Booster Dose in Adults Aged 18 Years and Above","A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ⅲb Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of COVID-19 Vaccine (Vero Cell), Inactivated Booster Dose in Adults Aged 18 Years and Above",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Sinovac Biotech Co., Ltd",,3.0,,The plan has changed,f,,,,f,f,f,,,,,,,,,,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,INDUSTRY,,,,,,,2023,0.0
NCT02548351,,2015-09-01,2024-08-14,,2024-09-05,2015-09-10,2015-09-14,ESTIMATED,2024-08-14,2024-09-05,ACTUAL,,,,2024-09-05,2024-10-01,ACTUAL,2015-09-22,ACTUAL,2015-09-22,2024-09,2024-09-30,2023-09-15,ACTUAL,2023-09-15,2023-09-15,ACTUAL,2023-09-15,,INTERVENTIONAL,REGENERATE,,Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment,"A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis",TERMINATED,,PHASE3,2477.0,ACTUAL,Intercept Pharmaceuticals,,3.0,,The FDA issued a CRL in response to Intercept's NDA for OCA for the treatment of NASH. Sponsor decided to terminate 747-303 before the planned completion date.,f,,,,t,,,,,,,,,,,,,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,INDUSTRY,,,,,,,2023,0.0
NCT04143594,,2019-10-28,2022-09-29,,2024-09-09,2019-10-28,2019-10-29,ACTUAL,2022-11-22,2022-12-19,ACTUAL,,,,2024-09-09,2024-10-02,ACTUAL,2019-11-22,ACTUAL,2019-11-22,2024-09,2024-09-30,2023-09-19,ACTUAL,2023-09-19,2021-10-05,ACTUAL,2021-10-05,,INTERVENTIONAL,CALIBRATE,Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.,Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV,"A Phase 2 Randomized, Open Label, Active Controlled Study Evaluating the Safety and Efficacy of Long-acting Capsid Inhibitor GS-6207 in Combination With Other Antiretroviral Agents in People Living With HIV",COMPLETED,,PHASE2,183.0,ACTUAL,Gilead Sciences,,4.0,,,f,,,,t,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gileadclinicaltrials.com/transparency-policy#Commitment,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment",2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,INDUSTRY,,,,,,,2023,1.0
NCT04028466,,2019-07-06,,,2023-11-20,2019-07-19,2019-07-22,ACTUAL,,,,,,,2023-11-20,2023-11-22,ACTUAL,2019-05-26,ACTUAL,2019-05-26,2023-11,2023-11-30,2020-03-30,ACTUAL,2020-03-30,2020-03-30,ACTUAL,2020-03-30,,INTERVENTIONAL,,,Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features,"Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features in a Primary Care Setting: A Pragmatic, Randomized, Single Blind Study",TERMINATED,,PHASE4,82.0,ACTUAL,"St. Luke's Medical Center, Philippines",,2.0,,Budget for the study was withdrawn and discontinued,f,,,,t,f,f,,,,,,,,,UNDECIDED,Approval from the Institutional review board should be secured before IPD will be made available,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,OTHER,,,,,,,2020,0.0
NCT04281004,,2020-02-19,2024-01-12,,2024-04-17,2020-02-19,2020-02-21,ACTUAL,2024-04-17,2024-04-18,ACTUAL,,,,2024-04-17,2024-04-18,ACTUAL,2020-07-10,ACTUAL,2020-07-10,2024-04,2024-04-30,2023-01-16,ACTUAL,2023-01-16,2023-01-16,ACTUAL,2023-01-16,,INTERVENTIONAL,,The population includes all subjects who provide informed consent and who are randomized into the trial and who have analyzable primary outcome data for at least one PRK-treated eye.,Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK),"A Phase I/II Randomized, Double-Masked Placebo-Controlled Study For Determining The Safety Of Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy",COMPLETED,,PHASE1/PHASE2,61.0,ACTUAL,University of Utah,"The limitations of this study include small sample size and limited duration for follow-up. A larger sample size may reveal whether pAF has a protective effect against haze formation, as haze after PRK is rare. Longer duration of follow-up can reveal whether it influences final visual acuity outcomes or late haze formation.",2.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,OTHER,,,,,,,2023,1.0
NCT04978818,,2021-07-16,2024-05-28,,2024-06-20,2021-07-16,2021-07-27,ACTUAL,2024-06-20,2024-06-24,ACTUAL,,,,2024-06-20,2024-06-24,ACTUAL,2022-01-27,ACTUAL,2022-01-27,2024-06,2024-06-30,2023-10-26,ACTUAL,2023-10-26,2023-10-26,ACTUAL,2023-10-26,,INTERVENTIONAL,,,Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study),Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children,COMPLETED,,PHASE4,333.0,ACTUAL,Johns Hopkins Bloomberg School of Public Health,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,OTHER,,,,,,,2023,1.0
NCT04030247,,2019-07-19,2022-03-31,,2022-03-31,2019-07-19,2019-07-23,ACTUAL,2022-03-31,2022-04-27,ACTUAL,,,,2022-03-31,2022-04-27,ACTUAL,2020-01-06,ACTUAL,2020-01-06,2022-03,2022-03-31,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,,Participants who completed the protocol are included in the analysis.,Impact of Plant Sterol Supplement on LDL-C Lowering in Low-to-Moderate Risk South Asian Patients,Impact of Plant Sterol Supplement on LDL-C Lowering in Low-to-Moderate Risk South Asian Patients Participating in a Cardiovascular Disease Prevention Program,COMPLETED,,PHASE4,50.0,ACTUAL,Stanford University,,1.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,OTHER,,,,,,,2021,1.0
NCT04421209,,2020-06-04,,,2021-03-12,2020-06-04,2020-06-09,ACTUAL,,,,,,,2021-03-12,2021-03-16,ACTUAL,2020-12,ESTIMATED,2020-12-31,2021-03,2021-03-31,2021-09-30,ESTIMATED,2021-09-30,2021-06-30,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,Analgesic Effects of Perioperative Propranolol Administration for Spine Surgery,Analgesic Effects of Perioperative Propranolol Administration for Spine Surgery,WITHDRAWN,,PHASE2,0.0,ACTUAL,Duke University,,2.0,,No funding source,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 01:09:28.991635,2024-10-15 01:09:28.991635,OTHER,,,,,,,2021,0.0
NCT01809002,,2013-03-04,2023-02-09,,2023-07-05,2013-03-08,2013-03-12,ESTIMATED,2023-07-05,2023-07-12,ACTUAL,,,,2023-07-05,2023-07-12,ACTUAL,2015-06,ACTUAL,2015-06-30,2023-07,2023-07-31,2021-08-30,ACTUAL,2021-08-30,2021-08-30,ACTUAL,2021-08-30,,INTERVENTIONAL,RECON,,Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair,"A Multicenter, Prospective, Randomized, Subject and Evaluator Blinded Comparative Study of Nerve Cuffs and Avance® Nerve Graft Evaluating Recovery Outcomes for the Repair of Nerve Discontinuities",COMPLETED,,PHASE3,220.0,ACTUAL,Axogen Corporation,"It is important to refer to the population being analyzed and the analysis methodology, as certain analyses include a repeated measures mixed modeling approach to address missing or incomplete data, while other analyses were conducted with as reported data. This resulted in certain populations containing extrapolated data for missing or incomplete data points and others excluded those subjects from the analysis.",2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,INDUSTRY,,,,,,,2021,1.0
NCT06621342,,2023-01-24,,,2024-09-27,2024-09-27,2024-10-01,ACTUAL,,,,,,,2024-09-27,2024-10-01,ACTUAL,2023-02-16,ACTUAL,2023-02-16,2023-01,2023-01-31,2023-02-16,ACTUAL,2023-02-16,2023-02-16,ACTUAL,2023-02-16,,INTERVENTIONAL,,,Platelet Rich Plasma Uterine Infusion,Evaluating Cytokine Concentrations in the Endometrium Before and After Autologous Platelet Rich Plasma Uterine Infusion Preceding Frozen Embryo Transfer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Kansas Medical Center,,2.0,,Study deferred/stopped by initiator before any study recruitment was initiated.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,OTHER,,,,,,,2023,0.0
NCT03592277,,2018-06-18,2022-03-22,,2022-09-09,2018-07-09,2018-07-19,ACTUAL,2022-09-09,2022-09-28,ACTUAL,,,,2022-09-09,2022-09-28,ACTUAL,2018-09-14,ACTUAL,2018-09-14,2022-09,2022-09-30,2021-02-22,ACTUAL,2021-02-22,2021-02-22,ACTUAL,2021-02-22,,INTERVENTIONAL,,,Vitamin C & Thiamine to Treat Sepsis and Septic Shock,Vitamins B1 and C to Improve Outcomes in Patients With Severe Sepsis,COMPLETED,,PHASE2,120.0,ACTUAL,Trinity Health Of New England,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,OTHER,,,,,,,2021,1.0
NCT03237182,,2017-07-27,,,2023-08-30,2017-07-31,2017-08-02,ACTUAL,,,,,,,2023-08-30,2023-09-01,ACTUAL,2017-06-14,ACTUAL,2017-06-14,2023-08,2023-08-31,2022-12-19,ACTUAL,2022-12-19,2022-12-19,ACTUAL,2022-12-19,,INTERVENTIONAL,InDEX,,The Individualized M(X) Drug-resistant TB Treatment Strategy Study,The Individualized M(X) Drug-resistant TB Treatment Strategy Study A Strategy to Improve Treatment Outcomes in Patients With Drug-resistant TB,TERMINATED,,PHASE4,205.0,ACTUAL,Centre for the AIDS Programme of Research in South Africa,,2.0,,WHO 2022 guidelines for DR-TB treatment are set to change. These guidelines recommend the use of an all-oral short course BPAL regimen.Therefore ongoing implementation of the study is considered futile.,f,,,,t,f,f,,,,,,Beginning 9 months and ending 36 months following article publication,Investigators wishing to access data from this study will need to contact the PI to request the data. Requests may be submitted up to 36 months following article publication. Investigators will need to complete a proposal for how the data will be used. The proposal will be reviewed by the CAPRISA Scientific Review Committee and the CAPRISA Executive Committee.,,YES,"Individual participant data that underlie the results of the objectives of the study, after deidentification",2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,NETWORK,,,,,,,2022,0.0
NCT04101682,,2019-08-26,,,2023-10-16,2019-09-22,2019-09-24,ACTUAL,,,,,,,2023-10-16,2023-10-18,ACTUAL,2020-09-25,ACTUAL,2020-09-25,2023-10,2023-10-31,2022-05-17,ACTUAL,2022-05-17,2022-05-17,ACTUAL,2022-05-17,,INTERVENTIONAL,,,Continuous Vs Single Shot Block After ACL,Continuous Vs Single Shot Adductor Canal Block After ACL Reconstruction - A Randomized Study,TERMINATED,,EARLY_PHASE1,9.0,ACTUAL,Northwell Health,,2.0,,Not enough enrollment,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,OTHER,,,,,,,2022,0.0
NCT02797067,,2016-05-29,2021-09-08,,2022-03-07,2016-06-10,2016-06-13,ESTIMATED,2022-03-07,2022-05-26,ACTUAL,,,,2022-03-07,2022-05-26,ACTUAL,2016-05-31,ACTUAL,2016-05-31,2022-03,2022-03-31,2021-08,ACTUAL,2021-08-31,2019-07,ACTUAL,2019-07-31,,INTERVENTIONAL,RIPEP,,Rectal Indomethacin to Prevent Post ESWL-pancreatitis,Rectally Administered Indomethacin to Prevent Post-ESWL-pancreatitis (RIPEP),COMPLETED,,PHASE4,1370.0,ACTUAL,Changhai Hospital,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,OTHER,,,,,,,2021,1.0
NCT05978063,,2023-07-25,,,2024-06-20,2023-08-03,2023-08-07,ACTUAL,,,,,,,2024-06-20,2024-06-21,ACTUAL,2023-08-01,ACTUAL,2023-08-01,2024-06,2024-06-30,2024-05-07,ACTUAL,2024-05-07,2024-04-22,ACTUAL,2024-04-22,,INTERVENTIONAL,,,Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica,"A 2-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate-to-Severe Pruritus in Adult Subjects With Notalgia Paresthetica",TERMINATED,,PHASE2/PHASE3,214.0,ACTUAL,"Cara Therapeutics, Inc.",,4.0,,"In Part A of CR845-310601, oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo. The drug was generally well tolerated with a safety profile similar to prior trials.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,INDUSTRY,,,,,,,2024,0.0
NCT04184323,,2019-11-27,,,2021-11-08,2019-12-02,2019-12-03,ACTUAL,,,,,,,2021-11-08,2021-11-17,ACTUAL,2022-01,ESTIMATED,2022-01-31,2020-11,2020-11-30,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,SAFER,,SIRT-1 Antagonism for Endometrial Receptivity,SIRT1-1 Antagonist Therapy Before Embryo Transfer to Improve Endometrial Receptivity and Life Pregnancy Rates,WITHDRAWN,,PHASE2,0.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,Lack of funding,f,,,,t,t,f,,,f,,,After completion of the study that includes live birth data,,,YES,"The demographic data, group assignment, and outcome data for each subject will be shared with other researchers including embryo grade, stage, pregnancy results (pregnant, not pregnant, miscarriage, ongoing pregnancy, Live birth)",2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,OTHER,,,,,,,2023,0.0
NCT04631705,,2020-11-10,2022-12-06,,2024-06-19,2020-11-14,2020-11-17,ACTUAL,2024-06-19,2024-10-03,ACTUAL,,,,2024-06-19,2024-10-03,ACTUAL,2020-12-14,ACTUAL,2020-12-14,2024-06,2024-06-30,2021-09-23,ACTUAL,2021-09-23,2021-09-23,ACTUAL,2021-09-23,,INTERVENTIONAL,,,SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Inhalation,A Phase 1/2a Trial of the Inhaled Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals,TERMINATED,,PHASE1/PHASE2,45.0,ACTUAL,University of Cologne,"- Small sample size, further reduced by early termination",7.0,,Change in viral variant epidemiology,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 14:54:22.532451,2024-10-15 14:54:22.532451,OTHER,,,,,,,2021,0.0
NCT03688568,,2018-09-11,,,2021-02-09,2018-09-26,2018-09-28,ACTUAL,,,,,,,2021-02-09,2021-02-12,ACTUAL,2018-09-01,ACTUAL,2018-09-01,2021-02,2021-02-28,2021-09-01,ESTIMATED,2021-09-01,2020-09-01,ACTUAL,2020-09-01,,INTERVENTIONAL,,,Study of Imatinib in Children With Neurofibromatosis and Airway Tumors,Phase 2 Study of Imatinib in Children With Neurofibromatosis and Airway Tumors,WITHDRAWN,,PHASE2,0.0,ACTUAL,Indiana University,,1.0,,Enrollment not feasible,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 01:15:09.927277,2024-10-15 01:15:09.927277,OTHER,,,,,,,2021,0.0
NCT03794258,,2019-01-03,,,2020-05-05,2019-01-03,2019-01-07,ACTUAL,,,,,,,2020-05-05,2020-05-07,ACTUAL,2019-05-01,ACTUAL,2019-05-01,2020-05,2020-05-31,2020-04-30,ACTUAL,2020-04-30,2020-04-15,ACTUAL,2020-04-15,,INTERVENTIONAL,,,Triple or Quadruple Combination DAAs Treatment for Subjects With HCV GT 1b Infection,"A Phase 2a, Open-label, Randomized Study of the Safety and Preliminary Efficacy of Triple or Quadruple Combination DAAs With Ultra-short Duration Therapy in Subjects With HCV Genotype 1b Infection (YANGTZE Study)",WITHDRAWN,,PHASE2,0.0,ACTUAL,Humanity & Health Medical Group Limited,,2.0,,Can not recruit the patients due to the pandemic of COVID-19,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,OTHER,,,,,,,2020,0.0
NCT05212662,,2022-01-26,,,2024-09-27,2022-01-26,2022-01-28,ACTUAL,,,,,,,2024-09-27,2024-10-01,ACTUAL,2024-09-27,ACTUAL,2024-09-27,2024-09,2024-09-30,2024-09-27,ACTUAL,2024-09-27,2024-09-27,ACTUAL,2024-09-27,,INTERVENTIONAL,,,Study of Cysteamine-pantetheine Disulfide (TTI-0102) in Mild to Moderate COVID-19,"A Multi-center, Randomized, Double-blind, Placebo-controlled, Study to Assess the Safety, Tolerability, Pharmacodynamics (PD) and Efficacy of TTI-0102 for the Treatment of Patients With Mild to Moderate COVID-19",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Thiogenesis Therapeutics, Inc.",,2.0,,Sponsor is not pursuing the COVID-19 indication at this time.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 22:39:10.997493,2024-10-16 22:39:10.997493,INDUSTRY,,,,,,,2024,0.0
NCT03072238,,2017-03-02,2023-03-15,2021-03-15,2024-05-22,2017-03-02,2017-03-07,ACTUAL,2023-03-15,2023-04-10,ACTUAL,2021-03-15,2021-03-19,ACTUAL,2024-05-22,2024-06-07,ACTUAL,2017-06-30,ACTUAL,2017-06-30,2024-05,2024-05-31,2024-04-24,ACTUAL,2024-04-24,2020-03-16,ACTUAL,2020-03-16,,INTERVENTIONAL,IPATential150,,"Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer","A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer",COMPLETED,,PHASE3,1101.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,INDUSTRY,,,,,,,2024,1.0
NCT03353350,,2017-11-21,2021-09-29,2021-01-26,2022-01-11,2017-11-21,2017-11-27,ACTUAL,2022-01-11,2022-01-18,ACTUAL,2022-01-11,2022-01-18,ACTUAL,2022-01-11,2022-01-18,ACTUAL,2017-12-05,ACTUAL,2017-12-05,2022-01,2022-01-31,2020-09-07,ACTUAL,2020-09-07,2020-01-29,ACTUAL,2020-01-29,,INTERVENTIONAL,AMPLITUDE-M,,Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise,"A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise",COMPLETED,,PHASE3,406.0,ACTUAL,Hanmi Pharmaceutical Company Limited,,4.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,INDUSTRY,,,,,,,2020,1.0
NCT01438684,,2011-09-21,,,2018-02-04,2011-09-21,2011-09-22,ESTIMATED,,,,,,,2018-02-04,2018-02-06,ACTUAL,2012-09,,2012-09-30,2017-08,2017-08-31,2020-10,ESTIMATED,2020-10-31,2019-01,ESTIMATED,2019-01-31,,INTERVENTIONAL,RPh-in-CVS,,The Impact of RPh201 on Chronic Vegetative State (CVS): fMRI Study,Phase 1 Study of RPh201 in Patients With Chronic Vegetative or Minimal Conscious State,SUSPENDED,,PHASE1,10.0,ESTIMATED,Hadassah Medical Organization,,2.0,,due to lack of supply of medication and technical problems with the MRI,f,,,,,,,,,,,,,,,,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,OTHER,,,,,,,2020,0.0
NCT04397458,,2020-05-04,,,2023-11-01,2020-05-20,2020-05-21,ACTUAL,,,,,,,2023-11-01,2023-11-03,ACTUAL,2022-01-01,ESTIMATED,2022-01-01,2023-11,2023-11-30,2022-06-30,ESTIMATED,2022-06-30,2022-06-30,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,Rescue Quadratus Lumborum Blocks for Post-cesarean Pain,Rescue Quadratus Lumborum Blocks for Post-cesarean Pain,WITHDRAWN,,PHASE4,0.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,COVID-19 pandemic and competing study that took precedence,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 01:15:09.927277,2024-10-15 01:15:09.927277,OTHER,,,,,,,2022,0.0
NCT03740997,,2018-10-31,2024-03-27,,2024-05-13,2018-11-13,2018-11-14,ACTUAL,2024-05-13,2024-05-17,ACTUAL,,,,2024-05-13,2024-05-17,ACTUAL,2020-12-01,ACTUAL,2020-12-01,2024-03,2024-03-31,2023-03-30,ACTUAL,2023-03-30,2023-03-30,ACTUAL,2023-03-30,,INTERVENTIONAL,,The Safety population consisted of all enrolled participants who received \>=1 dose of OPTISON in the study.,Study to Determine Safety and Dosage of OPTISON in Pediatric Participants,"A Phase 4, Open-Label, Non-Randomized, Multicenter Study to Evaluate Safety and Efficacy of Intravenous Administration of OPTISON™ for Contrast- Enhanced Echocardiography in Pediatric Patients",COMPLETED,,PHASE4,39.0,ACTUAL,GE Healthcare,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,INDUSTRY,,,,,,,2023,1.0
NCT05047601,,2021-09-01,2023-04-11,,2023-04-11,2021-09-15,2021-09-17,ACTUAL,2023-04-11,2023-05-06,ACTUAL,,,,2023-04-11,2023-05-06,ACTUAL,2021-09-09,ACTUAL,2021-09-09,2023-04,2023-04-30,2022-04-12,ACTUAL,2022-04-12,2022-04-12,ACTUAL,2022-04-12,,INTERVENTIONAL,,FAS (Full Analysis Set) included all participants randomly assigned to study intervention regardless of whether or not study intervention was administered.,A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection,"A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 2 REGIMENS OF ORALLY ADMINISTERED PF 07321332/RITONAVIR IN PREVENTING SYMPTOMATIC SARS-COV-2 INFECTION IN ADULT HOUSEHOLD CONTACTS OF AN INDIVIDUAL WITH SYMPTOMATIC COVID-19",COMPLETED,,PHASE2/PHASE3,2954.0,ACTUAL,Pfizer,,3.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,INDUSTRY,,,,,,,2022,1.0
NCT04371653,,2020-04-22,,,2024-05-10,2020-04-30,2020-05-01,ACTUAL,,,,,,,2024-05-10,2024-05-14,ACTUAL,2023-12-01,ESTIMATED,2023-12-01,2024-05,2024-05-31,2024-12-01,ESTIMATED,2024-12-01,2024-12-01,ESTIMATED,2024-12-01,,INTERVENTIONAL,,,"A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally in Subjects With Nonalcoholic Fatty Liver Disease","A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Nonalcoholic Fatty Liver Disease (NAFLD)",WITHDRAWN,,PHASE2,0.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,lack of funds,,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,OTHER,,,,,,,2024,0.0
NCT03995901,,2019-06-13,,,2023-03-01,2019-06-20,2019-06-24,ACTUAL,,,,,,,2023-03-01,2023-03-03,ACTUAL,2019-10-25,ACTUAL,2019-10-25,2023-03,2023-03-31,2023-02-16,ACTUAL,2023-02-16,2023-02-16,ACTUAL,2023-02-16,,INTERVENTIONAL,FREEDOM-1,,A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation,"A Randomized, Controlled, Multi-center, Safety and Efficacy Study of FCR001 Cell-based Therapy Relative to a Tacrolimus and Mycophenolate-based Regimen in de Novo Living Donor Renal Transplant Recipients, and Safety in FCR001 Donors",TERMINATED,,PHASE3,15.0,ACTUAL,Talaris Therapeutics Inc.,,2.0,,Talaris decided to discontinue living donor kidney transplant development program,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,INDUSTRY,,,,,,,2023,0.0
NCT03838692,,2019-02-11,,,2021-10-06,2019-02-11,2019-02-12,ACTUAL,,,,,,,2021-10-06,2021-10-13,ACTUAL,2019-07-26,ACTUAL,2019-07-26,2021-10,2021-10-31,2021-06-14,ACTUAL,2021-06-14,2021-06-14,ACTUAL,2021-06-14,,INTERVENTIONAL,,,Ponatinib in Advanced or Metastatic Medullary Thyroid Cancer,A Study of Ponatinib in Advanced or Metastatic Medullary Thyroid Cancer (MTC),WITHDRAWN,,PHASE2,0.0,ACTUAL,Columbia University,,1.0,,Closed by sponsor,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,OTHER,,,,,,,2021,0.0
NCT04932915,,2021-06-18,,,2022-02-02,2021-06-18,2021-06-21,ACTUAL,,,,,,,2022-02-02,2022-02-21,ACTUAL,2021-09-03,ACTUAL,2021-09-03,2022-02,2022-02-28,2022-01-10,ACTUAL,2022-01-10,2022-01-10,ACTUAL,2022-01-10,,INTERVENTIONAL,PREVENT,,Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19,A Randomized Placebo-controlled Phase 2 Study to Assess the Safety and Efficacy of UNI91103 Intranasal Administration in Adults With Asymptomatic or Mildly Symptomatic COVID-19,TERMINATED,,PHASE2,4.0,ACTUAL,UNION therapeutics,,2.0,,Failure of recruiting patients,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,INDUSTRY,,,,,,,2022,0.0
NCT03363659,,2017-11-30,2023-06-28,,2024-10-01,2017-11-30,2017-12-06,ACTUAL,2023-09-05,2023-09-08,ACTUAL,,,,2024-10-01,2024-10-03,ACTUAL,2018-03-28,ACTUAL,2018-03-28,2023-01,2023-01-31,2022-01-13,ACTUAL,2022-01-13,2022-01-13,ACTUAL,2022-01-13,,INTERVENTIONAL,,"15 subjects consented, 1 subject was a screen fail and 1 subject withdrew before any planned intervention.",Disulfiram and Copper Gluconate With Temozolomide in Unmethylated Glioblastoma Multiforme,"A Phase II, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Disulfiram and Copper Gluconate When Added to Standard Temozolomide Treatment in Patients With Newly Diagnosed Resected Unmethylated Glioblastoma Multiforme",TERMINATED,,PHASE2,15.0,ACTUAL,Wake Forest University Health Sciences,,1.0,,Investigator decision,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,OTHER,,,,,,,2022,0.0
NCT04994431,,2021-07-29,,,2024-09-27,2021-07-29,2021-08-06,ACTUAL,,,,,,,2024-09-27,2024-10-01,ACTUAL,2021-08-01,ACTUAL,2021-08-01,2024-09,2024-09-30,2023-10-04,ACTUAL,2023-10-04,2023-10-04,ACTUAL,2023-10-04,,INTERVENTIONAL,POUR,,Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin,Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin,TERMINATED,,PHASE4,8.0,ACTUAL,"University of Massachusetts, Worcester",,2.0,,inability to recruit,f,,,,f,t,f,,,f,,,,,,NO,No plan to share data,2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,OTHER,,,,,,,2023,0.0
NCT03020199,,2016-09-23,2024-06-13,,2024-06-13,2017-01-11,2017-01-13,ESTIMATED,2024-06-13,2024-10-01,ACTUAL,,,,2024-06-13,2024-10-01,ACTUAL,2017-03-27,ACTUAL,2017-03-27,2024-06,2024-06-30,2023-06-16,ACTUAL,2023-06-16,2021-11-30,ACTUAL,2021-11-30,,INTERVENTIONAL,STEPin,Subject disposition and baseline characteristics and presented using Randomized Set.,Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis,"A Randomized, Multicenter STudy to Evaluate the Effect of Secukinumab 300 mg s.c. Administered During 52 Weeks to Patients Suffering From New-onset Moderate to Severe Plaque Psoriasis as Early Intervention Compared to Standard Treatment With Narrow-band UVB (STEPIn Study)",TERMINATED,,PHASE4,196.0,ACTUAL,Novartis,,2.0,,"The study ended early due to few patients left in the long-term extension phase, hindering significant conclusions. This early termination did not impact the study's main or secondary goals, and the decision was not related to any safety concerns.",f,,,,f,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,INDUSTRY,,,,,,,2023,0.0
NCT03151707,,2017-05-04,2024-01-11,,2024-03-04,2017-05-11,2017-05-12,ACTUAL,2024-03-04,2024-03-05,ACTUAL,,,,2024-03-04,2024-03-05,ACTUAL,2017-10-01,ACTUAL,2017-10-01,2024-03,2024-03-31,2022-09-30,ACTUAL,2022-09-30,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,,,The Effects of Nicotinamide Riboside Supplementation on Brain NAD+/NADH Ratio and Bioenergetics,The Effects of Nicotinamide Riboside Supplementation on Nicotinamide Adenine Dinucleotide (NAD+/NADH) Ratio and Bioenergetics,TERMINATED,,PHASE4,11.0,ACTUAL,Mclean Hospital,Early termination leading to small numbers of subjects analyzed,1.0,,Lack of funding and appropriate staff,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2022,0.0
NCT04588298,,2020-09-08,,,2023-08-02,2020-10-08,2020-10-19,ACTUAL,,,,,,,2023-08-02,2023-08-03,ACTUAL,2020-11-02,ACTUAL,2020-11-02,2023-07,2023-07-31,2023-06-19,ACTUAL,2023-06-19,2023-06-19,ACTUAL,2023-06-19,,INTERVENTIONAL,SERENA-3,,"A Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2 Negative Primary Breast Cancer","A Randomised, Open-Label, Parallel-Group, Pre-surgical Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2-negative Primary Breast Cancer (SERENA-3)",COMPLETED,,PHASE2,135.0,ACTUAL,AstraZeneca,,7.0,,,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,INDUSTRY,,,,,,,2023,1.0
NCT04076423,,2019-08-27,,,2024-09-30,2019-08-30,2019-09-03,ACTUAL,,,,,,,2024-09-30,2024-10-01,ACTUAL,2019-10-10,ACTUAL,2019-10-10,2024-06,2024-06-30,2024-01-16,ACTUAL,2024-01-16,2023-06-15,ACTUAL,2023-06-15,,INTERVENTIONAL,InSTINCT,,A Phase IV Study to Assess the Impact of the Change of Antiretroviral Treatment From Dual Therapy to Triple Therapy on Inflammation in Patients With HIV Infection,"A Phase IV, Multicenter, Open and Randomized Study to Assess the Impact of the Change From Antiretroviral Treatment From Dual Therapy to Triple Therapy on Inflammation in Patients With Type 1 HIV Infection. InSTINCT Study",COMPLETED,,PHASE4,141.0,ACTUAL,Fundacion SEIMC-GESIDA,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,OTHER,,,,,,,2024,1.0
NCT05866926,,2023-05-10,,,2024-02-26,2023-05-10,2023-05-19,ACTUAL,,,,,,,2024-02-26,2024-02-28,ACTUAL,2023-03-06,ACTUAL,2023-03-06,2023-05,2023-05-31,2024-02-22,ACTUAL,2024-02-22,2024-01-09,ACTUAL,2024-01-09,,INTERVENTIONAL,ADOREXT,,Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis,"A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis",TERMINATED,,PHASE3,206.0,ACTUAL,Ferrer Internacional S.A.,,1.0,,After the analysis of the main ADORE study it is concluded that there is no clinical benefit for the patients.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,INDUSTRY,,,,,,,2024,0.0
NCT05062083,,2021-09-29,2024-04-29,,2024-06-24,2021-09-29,2021-09-30,ACTUAL,2024-06-24,2024-06-27,ACTUAL,,,,2024-06-24,2024-06-27,ACTUAL,2022-06-07,ACTUAL,2022-06-07,2024-01,2024-01-31,2024-01-30,ACTUAL,2024-01-30,2023-09-05,ACTUAL,2023-09-05,,INTERVENTIONAL,,,PET Imaging of Cyclooxygenase in Multiple Sclerosis,PET Imaging of Cyclooxygenases in Multiple Sclerosis,TERMINATED,,PHASE2,7.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,due to futility,f,,,,,t,f,,,,,,18 months after closure of protocol,Biomedical Translational Research Information System (BTRIS),,YES,.This study will also comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,NIH,,,,,,,2024,0.0
NCT04147650,,2019-10-30,2021-09-20,,2021-12-08,2019-10-30,2019-11-01,ACTUAL,2021-12-08,2021-12-10,ACTUAL,,,,2021-12-08,2021-12-10,ACTUAL,2019-10-14,ACTUAL,2019-10-14,2021-12,2021-12-31,2020-10-08,ACTUAL,2020-10-08,2020-09-17,ACTUAL,2020-09-17,,INTERVENTIONAL,AUDREY,,Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome,"A Randomized, Double-Masked, Vehicle-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution (VOS) in Subjects With Dry Eye Syndrome (DES)",COMPLETED,,PHASE2/PHASE3,508.0,ACTUAL,Aurinia Pharmaceuticals Inc.,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,INDUSTRY,,,,,,,2020,1.0
NCT04299438,,2020-02-25,2023-06-05,,2023-08-21,2020-03-03,2020-03-06,ACTUAL,2023-08-21,2023-08-23,ACTUAL,,,,2023-08-21,2023-08-23,ACTUAL,2020-07-14,ACTUAL,2020-07-14,2023-08,2023-08-31,2022-07-15,ACTUAL,2022-07-15,2022-06-15,ACTUAL,2022-06-15,,INTERVENTIONAL,PROPEL,trial stopped by DSMB after interim analysis,Propranolol Rescue of Prolonged Labor,"Propranolol Rescue of Prolonged Labor (PROPEL): A Randomized, Double-blind, Placebo-controlled Multicenter Investigation of Propranolol's Effect on Cesarean Delivery Rate Among Women With Prolonged Labor",TERMINATED,,PHASE3,164.0,ACTUAL,University of Pennsylvania,,2.0,,Stopped at interim analysis,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,OTHER,,,,,,,2022,0.0
NCT04157114,,2019-11-06,,,2022-02-23,2019-11-06,2019-11-08,ACTUAL,,,,,,,2022-02-23,2022-03-11,ACTUAL,2021-12,ESTIMATED,2021-12-31,2022-02,2022-02-28,2022-12,ESTIMATED,2022-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,MAP4343 Treatment for Alcohol Use Disorder,"A Double-Blind, Randomized, Controlled Trial of MAP4343 Treatment, a Ligand of the Neurospecific Microtubule Associated Protein-2, for Alcohol Use Disorder",WITHDRAWN,,PHASE2,0.0,ACTUAL,The Scripps Research Institute,,2.0,,The FDA requested Mapreg conduct an alcohol interaction study which was not feasible due to the COVID-19 pandemic.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,OTHER,,,,,,,2022,0.0
NCT04290442,,2020-02-26,,,2020-11-22,2020-02-26,2020-03-02,ACTUAL,,,,,,,2020-11-22,2020-11-24,ACTUAL,2021-01-01,ESTIMATED,2021-01-01,2020-11,2020-11-30,2021-06-01,ESTIMATED,2021-06-01,2021-03-15,ESTIMATED,2021-03-15,,INTERVENTIONAL,,,Adductor Canal Vs Adductor Canal Plus SPANK Block for Postoperative Pain in Knee Arthroplasty Surgery,A Prospective Randomized Parallel Study to Compare Post-operative Pain Control With Addition of Sensory Posterior Articular Nerve Block to Adductor Canal Block (SPANK) and Intraoperative Periarticular Infiltration in Total Knee Arthroplasty.,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Pittsburgh,,2.0,,"initially cessation due to covid, then fellow doing the study graduated with no time to complete the study; will take up again if a current fellow takes on the project",f,,,,f,t,f,,,,,,,,,NO,There is no plan to share individual participant data.,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,OTHER,,,,,,,2021,0.0
NCT03852901,,2019-02-22,2022-04-11,,2022-07-13,2019-02-22,2019-02-25,ACTUAL,2022-07-13,2022-08-02,ACTUAL,,,,2022-07-13,2022-08-02,ACTUAL,2019-03-28,ACTUAL,2019-03-28,2021-12-13,2021-12-13,2021-12-13,ACTUAL,2021-12-13,2020-11-12,ACTUAL,2020-11-12,,INTERVENTIONAL,,,Sodium-glucose Co Transporter 2 (sGLT2) Inhibitor and Endogenous Ketone Production,Sodium-Glucose CoTransporter 2 (sGLT2) Inhibitor and Endogenous Ketone Production,COMPLETED,,PHASE1,21.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,NIH,,,,,,,2021,1.0
NCT01121120,,2010-05-09,,,2020-12-07,2010-05-09,2010-05-12,ESTIMATED,,,,,,,2020-12-07,2020-12-08,ACTUAL,2010-06,,2010-06-30,2020-12,2020-12-31,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,TXA127-PBSC,,"Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant (PBSC) in Hodgkin, Non-Hodgkin Lymphoma or Multiple Myeloma Patients","Phase II Study Evaluating the Safety and Efficacy of TXA127 in the Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant in Patients With Hodgkin Lymphoma, Non-Hodgkin Lymphoma or Multiple Myeloma Undergoing Limited Reinfusion of CD34+ Cells",TERMINATED,,PHASE2,75.0,ACTUAL,Tarix Pharmaceuticals,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,INDUSTRY,,,,,,,2020,0.0
NCT04433585,,2020-06-15,2024-03-27,,2024-03-27,2020-06-15,2020-06-16,ACTUAL,2024-03-27,2024-04-23,ACTUAL,,,,2024-03-27,2024-04-23,ACTUAL,2020-08-19,ACTUAL,2020-08-19,2024-03,2024-03-31,2023-02-16,ACTUAL,2023-02-16,2023-01-10,ACTUAL,2023-01-10,,INTERVENTIONAL,ISLAND-SLE,,A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE),"A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus",COMPLETED,,PHASE2,291.0,ACTUAL,Nektar Therapeutics,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,INDUSTRY,,,,,,,2023,1.0
NCT03281304,,2017-09-11,2021-02-05,,2023-02-21,2017-09-11,2017-09-13,ACTUAL,2021-03-18,2021-04-15,ACTUAL,,,,2023-02-21,2023-03-21,ACTUAL,2017-11-16,ACTUAL,2017-11-16,2023-02,2023-02-28,2022-03-18,ACTUAL,2022-03-18,2020-02-14,ACTUAL,2020-02-14,,INTERVENTIONAL,,Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.,A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission,"A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION",TERMINATED,,PHASE4,140.0,ACTUAL,Pfizer,,2.0,,"The study terminated early due to business reasons, with the study already meeting its primary objective. The decision to terminate the trial was not based on any safety and/or efficacy concerns.",f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 01:15:09.927277,2024-10-15 01:15:09.927277,INDUSTRY,,,,,,,2022,0.0
NCT05332405,,2022-04-11,,,2023-06-27,2022-04-11,2022-04-18,ACTUAL,,,,,,,2023-06-27,2023-06-29,ACTUAL,2022-05-26,ACTUAL,2022-05-26,2023-06,2023-06-30,2024-04-01,ESTIMATED,2024-04-01,2023-10-01,ESTIMATED,2023-10-01,,INTERVENTIONAL,,,SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow,SPY Angiography To Determine the Extent of Nerve Release After Nerve Decompression,WITHDRAWN,,PHASE4,0.0,ACTUAL,NYU Langone Health,,1.0,,Obsolete study,f,,,,f,t,f,,,,,,,,,NO,IPD will only be used for this study,2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,OTHER,,,,,,,2024,0.0
NCT05169437,,2021-12-13,,,2024-09-26,2021-12-22,2021-12-27,ACTUAL,,,,,,,2024-09-26,2024-10-01,ACTUAL,2022-03-15,ACTUAL,2022-03-15,2024-09,2024-09-30,2024-08-27,ACTUAL,2024-08-27,2024-08-06,ACTUAL,2024-08-06,,INTERVENTIONAL,PAVO,,Niraparib in the Treatment of Patients with Advanced PALB2 Mutated Tumors,A Single-Arm Phase-II Study of Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations,TERMINATED,,PHASE2,22.0,ACTUAL,Tempus AI,,1.0,,Recruitment challenges,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,INDUSTRY,,,,,,,2024,0.0
NCT04459715,,2020-06-30,,,2024-09-29,2020-07-03,2020-07-07,ACTUAL,,,,,,,2024-09-29,2024-10-01,ACTUAL,2020-08-07,ACTUAL,2020-08-07,2024-09,2024-09-30,2024-09-18,ACTUAL,2024-09-18,2024-09-18,ACTUAL,2024-09-18,,INTERVENTIONAL,,,"A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)","A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)",TERMINATED,,PHASE3,730.0,ACTUAL,EMD Serono,,2.0,,Study has crossed the pre-defined futility boundary at the Interim Analysis.,f,,,,t,t,f,,,f,,,Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union,Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union,http://bit.ly/IPD21,YES,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21",2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,INDUSTRY,,,,,,,2024,0.0
NCT03718533,,2018-10-23,2021-11-03,,2024-02-27,2018-10-23,2018-10-24,ACTUAL,2023-05-18,2024-02-05,ACTUAL,,,,2024-02-27,2024-02-29,ACTUAL,2018-12-17,ACTUAL,2018-12-17,2024-02,2024-02-29,2020-11-03,ACTUAL,2020-11-03,2020-11-03,ACTUAL,2020-11-03,,INTERVENTIONAL,ELTION,,Study of Efficacy and Safety of Eltrombopag in Patients With Poor Graft Function,The ELTION Study - A Multicenter Open-label Interventional Study of Eltrombopag in Patients With Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation,TERMINATED,,PHASE2,10.0,ACTUAL,Novartis,,1.0,,"In the context of COVID-19 pandemic, the benefit / risk ratio of the participation of a patient with pancytopenia could be compromised. The decision of this premature termination was not the consequence of any safety reason inherent to the drug.",f,,,,f,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 01:26:21.754407,2024-10-16 01:26:21.754407,INDUSTRY,,,,,,,2020,0.0
NCT03688555,,2018-09-18,2021-11-12,,2022-03-09,2018-09-26,2018-09-28,ACTUAL,2021-11-12,2022-02-01,ACTUAL,,,,2022-03-09,2022-04-11,ACTUAL,2018-10-19,ACTUAL,2018-10-19,2022-03,2022-03-31,2020-12-01,ACTUAL,2020-12-01,2020-11-24,ACTUAL,2020-11-24,,INTERVENTIONAL,,This analysis set included all randomized participants who received at least one dose of the study treatment. Participants were evaluated according to the actual study treatment they received.,A Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis,"A Randomized, Double-blind, Placebo-controlled, 12-week Treatment Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis",COMPLETED,,PHASE2,10.0,ACTUAL,Idorsia Pharmaceuticals Ltd.,The study was initially planned as a single-center study. The protocol had to be updated accordingly for approvals for the second site in Germany.~The p-values need to be cautiously interpreted due to the small study population size.~Recruitment was put on hold on during the COVID-19 pandemic from 30 March to 28 May 2020 in Germany and from 31 March 2020 to 11 June 2020 in Belgium. Recruitment was subsequently restarted.,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 01:15:09.927277,2024-10-15 01:15:09.927277,INDUSTRY,,,,,,,2020,1.0
NCT04485130,,2020-07-22,2023-06-01,,2023-08-30,2020-07-22,2020-07-24,ACTUAL,2023-08-30,2023-09-13,ACTUAL,,,,2023-08-30,2023-09-13,ACTUAL,2021-08-18,ACTUAL,2021-08-18,2023-08,2023-08-31,2022-02-28,ACTUAL,2022-02-28,2022-02-28,ACTUAL,2022-02-28,,INTERVENTIONAL,DISCO,The trial stopped early so we were unable to enroll for Cohort 2.,DISulfiram for COvid-19 (DISCO) Trial,"DISulfiram for COvid-19 (DISCO) Trial: A Phase 2 Double-Blind, Randomized Placebo-Controlled Trial of Disulfiram Compared to Standard Care in Patients With Symptomatic COVID-19",TERMINATED,,PHASE2,11.0,ACTUAL,"University of California, San Francisco",,2.0,,"Low COVID case numbers, competing COVID treatments available",,,,,t,t,f,,,,,,After publication of study results,De-identified data,,YES,Planned sharing of de-identified individual participant data for the purposes of collaboration and meta-analyses.,2024-10-15 15:24:52.208295,2024-10-15 15:24:52.208295,OTHER,,,,,,,2022,0.0
NCT03988582,,2019-06-13,,,2020-06-09,2019-06-13,2019-06-17,ACTUAL,,,,,,,2020-06-09,2020-06-11,ACTUAL,2019-06-11,ACTUAL,2019-06-11,2020-06,2020-06-30,2020-06-08,ACTUAL,2020-06-08,2020-06-08,ACTUAL,2020-06-08,,INTERVENTIONAL,,,Safety and Effectiveness of EBV-specific Cytotoxic T Cells for the Treatment for EBV Lymphomas or Other EBV-associated Malignancies,A Phase II Trial of EBV-Specific Cytotoxic T Cells for the Treatment of EBV Lymphomas or Other EBV-associated Malignancies,WITHDRAWN,,PHASE2,0.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,3.0,,Lack of accrual,,,,,,t,f,,,,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,OTHER,,,,,,,2020,0.0
NCT03517566,,2018-03-27,2021-04-07,,2021-10-07,2018-04-24,2018-05-07,ACTUAL,2021-06-29,2021-07-20,ACTUAL,,,,2021-10-07,2021-10-08,ACTUAL,2018-11-14,ACTUAL,2018-11-14,2021-10,2021-10-31,2020-08-06,ACTUAL,2020-08-06,2020-07-15,ACTUAL,2020-07-15,,INTERVENTIONAL,,All subjects to whom study treatment was assigned. Two Mis-randomized (mis-randomized in Interactive Response Technology (IRT)) subjects in the placebo group were excluded. Mis-randomized subjects were defined as cases where IRT was contacted by the site either prematurely or inappropriately prior to confirmation of the subject's final randomization eligibility and no study medication was administered to the subject.,A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis,"A Randomized, Double-blind, Placebo-controlled Multicenter Dose Ranging Study to Assess the Safety and Efficacy of Multiple Oral ZPL389 Doses in Patients With Moderate to Severe Atopic Dermatitis (ZEST Trial)",TERMINATED,,PHASE2,293.0,ACTUAL,Novartis,,5.0,,Lack of efficacy,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 01:15:09.927277,2024-10-15 01:15:09.927277,INDUSTRY,,,,,,,2020,0.0
NCT04042116,,2019-07-19,,,2022-12-16,2019-07-30,2019-08-01,ACTUAL,,,,,,,2022-12-16,2022-12-20,ACTUAL,2019-07-29,ACTUAL,2019-07-29,2022-12,2022-12-31,2024-01,ESTIMATED,2024-01-31,2023-07,ESTIMATED,2023-07-31,,INTERVENTIONAL,,,A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor,"LIO-1: A Phase 1b/2, Open-Label Study to Evaluate the Safety and Efficacy of Lucitanib in Combination With Nivolumab in Patients With An Advanced, Metastatic Solid Tumor",SUSPENDED,,PHASE1/PHASE2,227.0,ESTIMATED,"Clovis Oncology, Inc.",,6.0,,Company decision,,,,,t,t,f,,,,,,"Data will be made available to qualified researchers after the primary, secondary, and/or exploratory outcomes of the study are reported or published and for 1 year thereafter.",Requests for de-identified datasets will be made available to qualified researchers following submission of a methodologically sound proposal to medinfo@clovisoncology.com.,,YES,De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations.~Data will be provided by Clovis Oncology.,2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,INDUSTRY,,,,,,,2024,0.0
NCT04776018,,2021-02-25,2024-07-30,,2024-09-09,2021-02-25,2021-03-01,ACTUAL,2024-09-09,2024-10-02,ACTUAL,,,,2024-09-09,2024-10-02,ACTUAL,2021-04-20,ACTUAL,2021-04-20,2024-09,2024-09-30,2023-11-09,ACTUAL,2023-11-09,2023-08-02,ACTUAL,2023-08-02,,INTERVENTIONAL,,"Safety analysis set included participants who received at least 1 dose, even if incomplete, of study drug.",A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM),"A Phase 1b/2 Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of TAK-981 in Combination With Monoclonal Antibodies in Adult Patients With Relapsed and/or Refractory Multiple Myeloma",TERMINATED,,PHASE1/PHASE2,27.0,ACTUAL,Takeda,The study was terminated early due to business reasons.,4.0,,Business Reasons,f,,,,,t,f,,,t,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,INDUSTRY,,,,,,,2023,0.0
NCT04772885,,2021-02-12,,,2022-10-21,2021-02-24,2021-02-26,ACTUAL,,,,,,,2022-10-21,2022-10-24,ACTUAL,2021-02-23,ACTUAL,2021-02-23,2022-10,2022-10-31,2022-10-20,ACTUAL,2022-10-20,2022-10-20,ACTUAL,2022-10-20,,INTERVENTIONAL,,,A Single and Multiple Ascending Dose Trial of KT-474 in Healthy Adult Volunteers and Patients With Atopic Dermatitis (AD) or Hidradenitis Suppurativa (HS),"A Phase 1 Randomized, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered KT-474 in Healthy Adult Volunteers and Patients With Atopic Dermatitis (AD) or Hidradenitis Suppurativa (HS)",COMPLETED,,PHASE1,154.0,ACTUAL,"Kymera Therapeutics, Inc.",,5.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,INDUSTRY,,,,,,,2022,1.0
NCT04129164,,2019-10-02,,2023-05-25,2024-09-30,2019-10-14,2019-10-16,ACTUAL,,,,,2023-05-30,ACTUAL,2024-09-30,2024-10-02,ACTUAL,2019-10-16,ACTUAL,2019-10-16,2024-09,2024-09-30,2023-03-10,ACTUAL,2023-03-10,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,SS,,A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome,"A Phase 2 Randomized, Double-blind, Placebo-controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in Subjects With Sjögren's Syndrome (SS)",COMPLETED,,PHASE2,183.0,ACTUAL,Amgen,,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,INDUSTRY,,,,,,,2023,1.0
NCT03603288,,2018-05-31,,2021-11-24,2021-11-24,2018-07-26,2018-07-27,ACTUAL,,,,,,,2021-11-24,2021-12-03,ACTUAL,2018-07-04,ACTUAL,2018-07-04,2021-11,2021-11-30,2020-11-25,ACTUAL,2020-11-25,2020-11-25,ACTUAL,2020-11-25,,INTERVENTIONAL,SIDEROS-E,,Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E),A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Who Completed the SIDEROS Study,TERMINATED,,PHASE3,161.0,ACTUAL,Santhera Pharmaceuticals,,1.0,,Interim analysis concluded to futility of main study SIDEROS (SNT-III-012),t,,,,t,t,f,,,,,,,,,,,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,INDUSTRY,,NCT03433807,NO_LONGER_AVAILABLE,,,,2020,0.0
NCT04040621,,2019-07-26,2022-03-25,,2022-03-25,2019-07-30,2019-08-01,ACTUAL,2022-03-25,2022-09-09,ACTUAL,,,,2022-03-25,2022-09-09,ACTUAL,2020-06-15,ACTUAL,2020-06-15,2022-03,2022-03-31,2021-05-07,ACTUAL,2021-05-07,2021-04-09,ACTUAL,2021-04-09,,INTERVENTIONAL,,The safety analysis set included all participants who received any amount of IV study dose of CAZ AVI.,Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia,"A PHASE 1, OPEN-LABEL, SINGLE-DOSE STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CEFTAZIDIME-AVIBACTAM (CAZ-AVI) IN CHILDREN FROM 3 MONTHS TO LESS THAN 18 YEARS OF AGE WHO ARE HOSPITALIZED AND RECEIVING SYSTEMIC ANTIBIOTIC THERAPY FOR SUSPECTED OR CONFIRMED NOSOCOMIAL PNEUMONIA, INCLUDING VENTILATOR-ASSOCIATED PNEUMONIA",TERMINATED,,PHASE1,4.0,ACTUAL,Pfizer,Only 4 participants were enrolled in this study. Outcome measures and AE data were not reported by cohort as planned in the protocol because doing so would risk re-dentification of the individual participants.,1.0,,"Following regulatory consultation, the Sponsor has decided to terminate the study and analyze the current dataset. The decision to terminate was solely based on a business decision, not due to safety concerns.",f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 01:15:09.927277,2024-10-15 01:15:09.927277,INDUSTRY,,,,,,,2021,0.0
NCT04752332,,2021-02-11,,,2024-07-24,2021-02-11,2021-02-12,ACTUAL,,,,,,,2024-07-24,2024-07-25,ACTUAL,2021-05-10,ACTUAL,2021-05-10,2024-07,2024-07-31,2024-06-26,ACTUAL,2024-06-26,2024-06-26,ACTUAL,2024-06-26,,INTERVENTIONAL,eMonarcHER,,A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer,"eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy",TERMINATED,,PHASE3,111.0,ACTUAL,Eli Lilly and Company,,2.0,,Study is terminated due to inability to enroll study participants,t,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 01:15:09.927277,2024-10-15 01:15:09.927277,INDUSTRY,,NCT03763604,AVAILABLE,,,,2024,0.0
NCT06061081,,2023-09-22,,,2024-09-27,2023-09-22,2023-09-29,ACTUAL,,,,,,,2024-09-27,2024-10-01,ACTUAL,2023-12-21,ACTUAL,2023-12-21,2024-09,2024-09-30,2024-11-04,ESTIMATED,2024-11-04,2024-11-04,ESTIMATED,2024-11-04,,INTERVENTIONAL,,,"A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1","A Randomized, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Adaptive Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in Treatment-Naïve Adults Living With HIV-1",SUSPENDED,,PHASE2,26.0,ESTIMATED,ViiV Healthcare,,2.0,,"Based on preliminary findings in a preclinical study of a similar maturation inhibitor, ViiV Healthcare have taken the decision to place the study 221773 of maturation inhibitor VH3739937 on temporary halt.",f,,,,f,t,f,,,f,,,"Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://www.gsk.com/en-gb/innovation/trials/data-transparency/,YES,Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/,2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,INDUSTRY,,,,,,,2024,0.0
NCT04506086,,2020-07-27,,,2024-10-15,2020-08-06,2020-08-10,ACTUAL,,,,,,,2024-10-15,2024-10-16,ESTIMATED,2021-08-26,ACTUAL,2021-08-26,2024-10,2024-10-31,2024-09-16,ACTUAL,2024-09-16,2024-09-16,ACTUAL,2024-09-16,,INTERVENTIONAL,,,Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL),"A Phase 4, Multi-center Open-label Feasibility Study to Evaluate Outpatient Blinatumomab Administration in Adult Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL) in Complete Hematologic Remission",TERMINATED,,PHASE4,10.0,ACTUAL,Amgen,,1.0,,The decision to terminate is not based on safety or efficacy but due to slow enrollment impacting the ability to complete the study as planned.,f,,,,f,t,t,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,INDUSTRY,,,,,,,2024,0.0
NCT04181515,,2019-11-24,,,2023-04-10,2019-11-27,2019-11-29,ACTUAL,,,,,,,2023-04-10,2023-04-13,ACTUAL,2023-04-10,ACTUAL,2023-04-10,2023-04,2023-04-30,2023-04-10,ACTUAL,2023-04-10,2023-04-10,ACTUAL,2023-04-10,,INTERVENTIONAL,OTC-1,,Using rTMS to Explore Neural Mechanisms of Stress-Induced Opioid Use,Using Repetitive Transcranial Magnetic Stimulation (rTMS) to Explore Neural Mechanisms of Stress-Induced Opioid Use,WITHDRAWN,,PHASE2,0.0,ACTUAL,Wayne State University,,4.0,,Lack of funding,f,,,,t,t,f,,,t,,,Available after the study is completed,Qualified investigators may apply in writing.,,YES,"After the study is completed, qualified investigators may apply in writing to receive the study protocol. At this time, it has not been determined whether data will be shared and the conditions for access.",2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,OTHER,,,,,,,2023,0.0
NCT05763875,,2023-02-28,,,2024-09-29,2023-02-28,2023-03-10,ACTUAL,,,,,,,2024-09-29,2024-10-01,ACTUAL,2023-03-15,ACTUAL,2023-03-15,2024-09,2024-09-30,2024-06-20,ACTUAL,2024-06-20,2024-06-20,ACTUAL,2024-06-20,,INTERVENTIONAL,V-Mono,,Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.,"A Double-blind, Randomized, Placebo- and Active-Comparator Controlled Study to Evaluate the Efficacy of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-Lowering Therapy (VictORION-Mono)",COMPLETED,,PHASE3,350.0,ACTUAL,Novartis,,3.0,,,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,INDUSTRY,,,,,,,2024,1.0
NCT04833959,,2021-04-02,,,2024-06-19,2021-04-02,2021-04-06,ACTUAL,,,,,,,2024-06-19,2024-06-21,ACTUAL,2021-03-26,ACTUAL,2021-03-26,2024-06,2024-06-30,2024-03,ESTIMATED,2024-03-31,2024-03,ESTIMATED,2024-03-31,,INTERVENTIONAL,,,Pilot Study of 89-Zr Panitumumab in Pancreas Cancer,Pilot Study of 89Zr Panitumumab in Pancreas Cancer,WITHDRAWN,,PHASE1,0.0,ACTUAL,Stanford University,,1.0,,Business Decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 01:15:09.927277,2024-10-15 01:15:09.927277,OTHER,,,,,,,2024,0.0
NCT03317119,,2017-10-18,,,2024-04-04,2017-10-18,2017-10-23,ACTUAL,,,,,,,2024-04-04,2024-04-08,ACTUAL,2018-04-11,ACTUAL,2018-04-11,2024-04,2024-04-30,2023-07-14,ACTUAL,2023-07-14,2023-07-14,ACTUAL,2023-07-14,,INTERVENTIONAL,,,"Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery",A Phase I Clinical Trial of Trametinib in Combination With TAS-102 in Patients With Chemotherapy-Resistant RAS-Mutated (PIK3CA/PTEN-Wild-Type) Metastatic Colorectal Cancer,COMPLETED,,PHASE1,26.0,ACTUAL,City of Hope Medical Center,,1.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-15 01:15:09.927277,2024-10-15 01:15:09.927277,OTHER,,,,,,,2023,0.0
NCT04064242,,2019-08-20,2024-09-09,,2024-09-09,2019-08-20,2019-08-21,ACTUAL,2024-09-09,2024-10-02,ACTUAL,,,,2024-09-09,2024-10-02,ACTUAL,2020-09-23,ACTUAL,2020-09-23,2024-09,2024-09-30,2023-12-12,ACTUAL,2023-12-12,2023-09-19,ACTUAL,2023-09-19,,INTERVENTIONAL,,,"Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis","A Subject and Investigator Blinded, Randomized, Placebo-controlled, Repeat-dose, Multicenter Study to Investigate Efficacy, Safety, and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis",COMPLETED,,PHASE2,62.0,ACTUAL,Novartis,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,INDUSTRY,,,,,,,2023,1.0
NCT01546571,,2012-02-26,,,2021-12-06,2012-03-01,2012-03-07,ESTIMATED,,,,,,,2021-12-06,2021-12-08,ACTUAL,2012-05-01,ACTUAL,2012-05-01,2021-12,2021-12-31,2021-06-30,ACTUAL,2021-06-30,2021-04-29,ACTUAL,2021-04-29,,INTERVENTIONAL,MAVIS,,"Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients","A Multicenter, Double-blind, Placebo-controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in Post-resection Melanoma Patients With a High Risk of Recurrence",TERMINATED,,PHASE3,504.0,ACTUAL,Polynoma LLC,,2.0,,"Planned interim analysis showed a strong signal of efficacy in a pre-specified patient population. Fast track designation was granted and a new, redesigned pivotal trial will be conducted.",f,,,,t,,,,,,,,,,,,,2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,INDUSTRY,,,,,,,2021,0.0
NCT03602066,,2018-07-17,2023-11-13,,2024-02-21,2018-07-17,2018-07-26,ACTUAL,2024-02-21,2024-03-20,ACTUAL,,,,2024-02-21,2024-03-20,ACTUAL,2019-02-14,ACTUAL,2019-02-14,2024-02,2024-02-29,2022-11-07,ACTUAL,2022-11-07,2022-11-07,ACTUAL,2022-11-07,,INTERVENTIONAL,,,Study Evaluating The Role of ClO2 on Mucositis for Pt. Undergoing Head/Neck Radiotherapy,A Pilot Phase II Study Evaluating the Role of Chlorine Dioxide on Mucositis for Patients Undergoing Head and Neck Radiotherapy,TERMINATED,,PHASE2,14.0,ACTUAL,University of Arizona,"This study stopped accrual early as the IP manufacturer terminated the study stopping funding and IP. 14 out of 20 subjects were accrued, 11 of which completed study. Due to early termination with few patients, only the counts of events have been calculated and no testing was done.",2.0,,Study terminated by pharmaceutical company,f,,,,t,t,f,,,,,,,,,,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,OTHER,,,,,,,2022,0.0
NCT04216589,,2019-12-30,2024-03-15,,2024-09-06,2019-12-30,2020-01-02,ACTUAL,2024-04-22,2024-05-17,ACTUAL,,,,2024-09-06,2024-10-01,ACTUAL,2021-02-19,ACTUAL,2021-02-19,2024-09,2024-09-30,2023-09-15,ACTUAL,2023-09-15,2023-03-16,ACTUAL,2023-03-16,,INTERVENTIONAL,,All participants who were enrolled to the study.,"Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome With Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)","A Single-Arm, Open-Label, Pilot Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome With Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)",COMPLETED,,PHASE2,51.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,1.0,,,f,,,,t,t,f,,,,,,Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.,* With whom?~  * Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses?~  * To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism will data be made available?~  * Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at: https://submit.mis.s-3.net/ Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.,,YES,"Individual participant data that underlie results in the publication, after deidentification.",2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,NIH,,,,,,,2023,1.0
NCT04756505,,2021-02-11,,,2023-12-21,2021-02-11,2021-02-16,ACTUAL,,,,,,,2023-12-21,2023-12-27,ACTUAL,2021-03-07,ACTUAL,2021-03-07,2023-12,2023-12-31,2022-02-16,ACTUAL,2022-02-16,2022-02-16,ACTUAL,2022-02-16,,INTERVENTIONAL,,,"Immunotherapy (NHS-IL12 & Bintrafusp Alfa) and Radiation Therapy for the Treatment of Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer, the REINA Trial","REINA: A Phase I Study of Radiation Enhanced IL 12-Necrosis Attraction in Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer Patients",WITHDRAWN,,PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Per Sponsor Request-no longer manufacturing the study drug,f,,,,f,t,f,,,,,,,,,,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2022,0.0
NCT04894123,,2021-05-16,,,2023-09-14,2021-05-16,2021-05-20,ACTUAL,,,,,,,2023-09-14,2023-09-18,ACTUAL,2022-02-07,ACTUAL,2022-02-07,2023-09,2023-09-30,2023-02-13,ACTUAL,2023-02-13,2023-02-13,ACTUAL,2023-02-13,,INTERVENTIONAL,,,Cardiovascular Events From Trifluridine/Tipiracil +/- Oxaliplatin in Colorectal/Oesogastric Adenocarcinoma Patients,A Phase II Study Evaluating the Rate of Cardiovascular Events During Trifluridine/Tipiracil +/- Oxaliplatin Treatment in Colorectal/Oesogastric Adenocarcinoma Patients That Have Experienced a Past Episode of Thoracic Angina-related Pain Due to Chemotherapy Including 5-fluorouracil/Capecitabine,TERMINATED,,PHASE2,1.0,ACTUAL,GERCOR - Multidisciplinary Oncology Cooperative Group,,1.0,,Recruitment failure,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,OTHER,,,,,,,2023,0.0
NCT05633992,,2022-11-21,2024-05-01,,2024-09-09,2022-11-21,2022-12-01,ACTUAL,2024-05-01,2024-05-30,ACTUAL,,,,2024-09-09,2024-10-02,ACTUAL,2023-01-10,ACTUAL,2023-01-10,2024-09,2024-09-30,2023-05-24,ACTUAL,2023-05-24,2023-05-24,ACTUAL,2023-05-24,,INTERVENTIONAL,,,"Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)","A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Japanese Adults 65 Years of Age or Older",COMPLETED,,PHASE3,450.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,f,t,f,,,t,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,INDUSTRY,,,,,,,2023,1.0
NCT04051320,,2019-08-07,2023-05-22,,2023-08-03,2019-08-07,2019-08-09,ACTUAL,2023-08-03,2023-08-25,ACTUAL,,,,2023-08-03,2023-08-25,ACTUAL,2020-01-02,ACTUAL,2020-01-02,2023-05,2023-05-31,2022-07-19,ACTUAL,2022-07-19,2022-07-15,ACTUAL,2022-07-15,,INTERVENTIONAL,,,Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model,Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model,COMPLETED,,PHASE2,23.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,,f,,,,,t,f,,,f,,,Deidentified individual data that supports the results will be shared beginning 18 to 24 months following publication.,"Approval from an IRB, IEC, or REB, as applicable and execution of a data use/sharing agreement with UNC.",,YES,"Deidentified individual data that supports the results will be shared beginning 18 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.",2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,OTHER,,,,,,,2022,1.0
NCT04497870,,2020-06-22,,,2023-12-07,2020-08-03,2020-08-04,ACTUAL,,,,,,,2023-12-07,2023-12-11,ACTUAL,2020-07-09,ACTUAL,2020-07-09,2023-12,2023-12-31,2023-09-14,ACTUAL,2023-09-14,2023-09-14,ACTUAL,2023-09-14,,INTERVENTIONAL,,,Peppermint Oil Pharmacokinetics/Dynamics,Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children With Functional Abdominal Pain,WITHDRAWN,,PHASE1,0.0,ACTUAL,Baylor College of Medicine,,2.0,,This study was superseded by NCT03295747,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,OTHER,,,,,,,2023,0.0
NCT03597035,,2018-03-05,2021-10-19,,2022-04-21,2018-07-13,2018-07-24,ACTUAL,2022-04-21,2022-05-16,ACTUAL,,,,2022-04-21,2022-05-16,ACTUAL,2018-07-17,ACTUAL,2018-07-17,2022-04,2022-04-30,2020-07-31,ACTUAL,2020-07-31,2020-07-23,ACTUAL,2020-07-23,,INTERVENTIONAL,MAGMAAddOn,,Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Add-On,Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Add-On,TERMINATED,,PHASE4,8.0,ACTUAL,University Hospitals Cleveland Medical Center,,1.0,,The study could not enroll patients owing to the inclusion exclusion criteria,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,OTHER,,,,,,,2020,0.0
NCT03093740,,2017-03-22,,,2018-12-18,2017-03-22,2017-03-28,ACTUAL,,,,,,,2018-12-18,2018-12-20,ACTUAL,2018-10-01,ESTIMATED,2018-10-01,2018-12,2018-12-31,2021-01-31,ESTIMATED,2021-01-31,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant,Use of Direct-acting Antiviral Therapy to Prevent Spread of HCV Infection for Patients Receiving a HCV Positive Kidney Transplant as a HCV Negative Recipient,WITHDRAWN,,PHASE4,0.0,ACTUAL,Massachusetts General Hospital,,2.0,,"Withdrew IRB application, never approved and no subjects enrolled",f,,,,t,t,f,,,f,,,,,,NO,No current plans to share participant data,2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,OTHER,,,,,,,2021,0.0
NCT05224856,,2022-02-03,,,2022-07-21,2022-02-03,2022-02-04,ACTUAL,,,,,,,2022-07-21,2022-07-25,ACTUAL,2022-04,ESTIMATED,2022-04-30,2022-07,2022-07-31,2023-01,ESTIMATED,2023-01-31,2022-11,ESTIMATED,2022-11-30,,INTERVENTIONAL,,,To Evaluate the Safety and Efficacy of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With COVID-19 Not Requiring Supplemental Oxygen,"A Phase 3, Randomized, Parallel-group, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With Coronavirus Disease 2019 (COVID-19) Not Requiring Supplemental Oxygen",WITHDRAWN,,PHASE3,0.0,ACTUAL,Celltrion,,2.0,,The sponsor has decided to stop development of the inhaled CT-P63/66 combination therapy.,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,INDUSTRY,,,,,,,2023,0.0
NCT05208866,,2022-01-07,2023-02-08,,2023-04-17,2022-01-07,2022-01-26,ACTUAL,2023-03-14,2023-04-10,ACTUAL,,,,2023-04-17,2023-05-12,ACTUAL,2022-02-10,ACTUAL,2022-02-10,2023-04,2023-04-30,2022-07-29,ACTUAL,2022-07-29,2022-06-29,ACTUAL,2022-06-29,,INTERVENTIONAL,,"Since only one participant completed the study, due to confidentiality issues, no data will be reported.",Roll-over Study to Assess Safety of Lixivaptan in Participants With ADPKD Who Completed Study PA-ADPKD-303,"PA-ADPKD-304: A Phase 3, Open-label, Roll-over Study to Assess Long-term Safety of Lixivaptan in Participants With Autosomal Dominant Polycystic Kidney Disease Who Completed Study PA-ADPKD-303: The ALERT Study",TERMINATED,,PHASE3,1.0,ACTUAL,Palladio Biosciences,Efficacy and safety results are limited by the early termination of the trial and the small number of subjects. Early termination was due to a sponsor decision for reasons unrelated to safety.,1.0,,The decision is based on a thorough reassessment of the commercial potential of lixivaptan as a potential best-in-class therapy for patients with ADPKD.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,INDUSTRY,,,,,,,2022,0.0
NCT04676126,,2020-12-09,,,2022-09-30,2020-12-17,2020-12-19,ACTUAL,,,,,,,2022-09-30,2022-10-04,ACTUAL,2021-05,ESTIMATED,2021-05-31,2022-09,2022-09-30,2022-05,ESTIMATED,2022-05-31,2022-05,ESTIMATED,2022-05-31,,INTERVENTIONAL,,,Augmented Macular Pigment-containing Nutraceutical and Central Visual Function,Augmented Macular Pigment Supplement and Pericentral Visual Function: a Randomized Controlled Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of the Incarnate Word,,2.0,,IRB records show administrative closure on 12/16/21. No subjects enrolled.,f,,,,f,t,f,,,,,,,,,NO,There is no plan to share IPD to other researches.,2024-10-15 15:24:52.208295,2024-10-15 15:24:52.208295,OTHER,,,,,,,2022,0.0
NCT02347891,,2015-01-22,2022-11-25,,2024-01-16,2015-01-22,2015-01-28,ESTIMATED,2024-01-16,2024-02-09,ACTUAL,,,,2024-01-16,2024-02-09,ACTUAL,2015-01,ACTUAL,2015-01-31,2024-01,2024-01-31,2020-11,ACTUAL,2020-11-30,2020-11,ACTUAL,2020-11-30,,INTERVENTIONAL,BIM,"29 screened, 19 enrolled, 2 withdrew consent before randomization. 17 patients started the trial and were randomized. Of 17 patients randomized, 15 received at least 5 doses of belimumab or placebo and were included in the final intention-to-treat analysis. 14 patients (8/9 in the belimumab arm and 6/7 in the placebo arm) completed all 40 weeks of randomized phase. Seven (7/9) patients from belimumab arm and 5 (5/7) from placebo arm completed 24 weeks of open label extension with IV belimumab.",Belimumab in Idiopathic Inflammatory Myositis,Belimumab for Maintenance Therapy in Idiopathic Inflammatory Myositis,COMPLETED,,PHASE2/PHASE3,17.0,ACTUAL,Northwell Health,,2.0,,,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,OTHER,,,,,,,2020,1.0
NCT02945644,,2016-10-11,,,2020-05-07,2016-10-24,2016-10-26,ESTIMATED,,,,,,,2020-05-07,2020-05-11,ACTUAL,2017-02-13,ACTUAL,2017-02-13,2020-05,2020-05-31,2020-12,ESTIMATED,2020-12-31,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,TrazoDose,,Trazodone Dose Tolerance and APAP Adherence,Randomized Controlled Trial of Trazodone Dose Tolerance and APAP Adherence,SUSPENDED,,PHASE1,45.0,ESTIMATED,Louis Stokes VA Medical Center,,3.0,,COVID19 pandemic,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 01:15:09.927277,2024-10-15 01:15:09.927277,FED,,,,,,,2020,0.0
NCT05737186,,2023-02-12,,,2024-04-27,2023-02-12,2023-02-21,ACTUAL,,,,,,,2024-04-27,2024-04-30,ACTUAL,2023-03-09,ACTUAL,2023-03-09,2024-04,2024-04-30,2024-04-16,ACTUAL,2024-04-16,2024-04-16,ACTUAL,2024-04-16,,INTERVENTIONAL,,,SGLT2 Inhibitors and Treatment of Heart Failure in Severe Renal Insufficiency,The Efficacy and Safety of SGLT2 Inhibitors in Improving Heart Failure in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) and Severe Renal Insufficiency,TERMINATED,,PHASE4,11.0,ACTUAL,Peking University People's Hospital,,2.0,,Double blind packaged drug is up to expiration date,f,,,,f,f,f,,,,,,,,,,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,OTHER,,,,,,,2024,0.0
NCT04853147,,2021-04-20,,,2022-12-26,2021-04-20,2021-04-21,ACTUAL,,,,,,,2022-12-26,2022-12-29,ACTUAL,2021-04-27,ACTUAL,2021-04-27,2022-12,2022-12-31,2022-10-12,ACTUAL,2022-10-12,2022-04-13,ACTUAL,2022-04-13,,INTERVENTIONAL,,,Triple Therapy for Postoperative Nausea and Vomiting in Laparoscopic Gastrointestinal Surgery,"Triple Combination of Fosaprepitant, Dexamethasone and Palonosetron Versus Combination of Dexamethasone and Palonosetron for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastrointestinal Surgery",COMPLETED,,PHASE3,1154.0,ACTUAL,"Sixth Affiliated Hospital, Sun Yat-sen University",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,OTHER,,,,,,,2022,1.0
NCT04460885,,2020-07-06,,2023-05-27,2024-07-03,2020-07-06,2020-07-08,ACTUAL,,,,,2023-05-31,ACTUAL,2024-07-03,2024-07-05,ACTUAL,2020-11-25,ACTUAL,2020-11-25,2024-07,2024-07-31,2022-12-01,ACTUAL,2022-12-01,2022-05-29,ACTUAL,2022-05-29,,INTERVENTIONAL,ONWARDS 1,,"A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before","A 78-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Treatment, in Insulin naïve Subjects With Type 2 Diabetes",COMPLETED,,PHASE3,984.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,INDUSTRY,,,,,,,2022,1.0
NCT05999708,,2023-08-11,,,2023-12-11,2023-08-11,2023-08-21,ACTUAL,,,,,,,2023-12-11,2023-12-15,ACTUAL,2023-10-31,ESTIMATED,2023-10-31,2023-12,2023-12-31,2024-12-05,ESTIMATED,2024-12-05,2024-12-05,ESTIMATED,2024-12-05,,INTERVENTIONAL,,,A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants,"A Randomized, Double-Blind, Placebo-Controlled, Single, Repeat Dose Escalation and Indomethacin Challenge Study to Evaluate Safety, Tolerability and Pharmacokinetics of GSK4381406 in Healthy Participants",WITHDRAWN,,PHASE1,0.0,ACTUAL,GlaxoSmithKline,,8.0,,Study terminated prior to FSFV for strategic business reasons.,f,,,,t,f,f,,,f,,,"Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://www.gsk.com/en-gb/innovation/trials/data-transparency/,YES,Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/,2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,INDUSTRY,,,,,,,2024,0.0
NCT02703272,,2016-03-03,2022-06-10,,2022-11-07,2016-03-03,2016-03-09,ESTIMATED,2022-11-07,2022-12-02,ACTUAL,,,,2022-11-07,2022-12-02,ACTUAL,2016-07-01,ACTUAL,2016-07-01,2022-11,2022-11-30,2021-06-11,ACTUAL,2021-06-11,2021-06-11,ACTUAL,2021-06-11,,INTERVENTIONAL,,,A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma,"A Randomized, Open-label, Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Patients With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma",TERMINATED,,PHASE3,72.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,"IDMC recommended that enrolment be stoped, as the EFS hazard ratio and associated p-value crossed the futility boundary specified in protocol (July 2020).",f,,,,t,,f,,,,,,,,,,,2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,INDUSTRY,,,,,,,2021,0.0
NCT03917472,,2019-04-11,2022-03-23,,2022-08-11,2019-04-15,2019-04-17,ACTUAL,2022-03-23,2022-04-21,ACTUAL,,,,2022-08-11,2022-08-12,ACTUAL,2019-07-17,ACTUAL,2019-07-17,2022-08,2022-08-31,2021-03-24,ACTUAL,2021-03-24,2021-03-24,ACTUAL,2021-03-24,,INTERVENTIONAL,KINGFISHER,,Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema,"A 12-Month, 2-Arm, Randomized, Double-Masked, Multicenter Phase III Study Assessing the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (KINGFISHER)",COMPLETED,,PHASE3,517.0,ACTUAL,Novartis,,2.0,,,f,,,,f,t,f,,,,,,,,https://clinicalstudydatarequest.com/Default.aspx,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of the patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,INDUSTRY,,,,,,,2021,1.0
NCT03389490,,2017-12-26,,,2021-08-02,2017-12-26,2018-01-03,ACTUAL,,,,,,,2021-08-02,2021-08-03,ACTUAL,2018-01-01,ACTUAL,2018-01-01,2021-08,2021-08-31,2020-05-01,ACTUAL,2020-05-01,2019-12-17,ACTUAL,2019-12-17,,INTERVENTIONAL,,,Toujeo Versus NPH Self-titration Study,A Pilot Study to Describe the Glycaemic Variability of Insulin Glargine 300U/ml Versus NPH (Neutral Protamine Hagedorn) in the Insulin-naïve Type 2 Diabetes Patients Following a Patient-adjusted Insulin Algorithm in Hong Kong,COMPLETED,,PHASE4,50.0,ACTUAL,Chinese University of Hong Kong,,2.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,OTHER,,,,,,,2020,1.0
NCT04325698,,2019-10-14,2022-04-29,,2024-06-25,2020-03-26,2020-03-27,ACTUAL,2024-06-25,2024-10-01,ACTUAL,,,,2024-06-25,2024-10-01,ACTUAL,2020-06-11,ACTUAL,2020-06-11,2024-06,2024-06-30,2021-05-10,ACTUAL,2021-05-10,2021-05-10,ACTUAL,2021-05-10,,INTERVENTIONAL,,,A BRIDGING STUDY OF PF-06439535 (CN) PLUS PACLITAXEL-CARBOPLATIN VERSUS BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN IN NSCLC,"A RANDOMIZED, DOUBLE-BLIND BRIDGING SAFETY AND EFFICACY STUDY OF PF-06439535 (CN) PLUS PACLITAXEL-CARBOPLATIN VERSUS BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF CHINESE PARTICIPANTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER",TERMINATED,,PHASE3,8.0,ACTUAL,Pfizer,"The study was terminated on 17 March 2021 by the Sponsor. The decision to terminate this study was based on a business review of the biosimilars market and the Sponsor's global manufacturing network. This decision was not based on any safety or regulatory concerns with the treatment of participants with PF-06439535 (CN). The results reported are limited to safety, PK and immunogenicity, and only safety is summarized.",2.0,,The study was terminated as part of the decision by Pfizer to halt its biosimilars programs in China.,f,,,,,f,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 22:46:07.58326,2024-10-16 22:46:07.58326,INDUSTRY,,,,,,,2021,0.0
NCT04855201,,2021-04-20,,,2023-12-11,2021-04-20,2021-04-22,ACTUAL,,,,,,,2023-12-11,2023-12-15,ACTUAL,2021-06-14,ACTUAL,2021-06-14,2023-12,2023-12-31,2022-12-16,ACTUAL,2022-12-16,2022-12-16,ACTUAL,2022-12-16,,INTERVENTIONAL,,,A Study to Evaluate ASP0367 in Participants With Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction,"A Phase 1b Multiple Oral Dose Study to Evaluate the Pharmacological Effect, Safety and Tolerability of ASP0367 in Participants With Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction",TERMINATED,,PHASE1,31.0,ACTUAL,Astellas Pharma Inc,,2.0,,Lack of Pharmacological effect,f,,,,t,t,f,,,,,,,,,NO,Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.,2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,INDUSTRY,,,,,,,2022,0.0
NCT05241470,,2022-01-05,2023-09-07,,2024-02-15,2022-02-04,2022-02-15,ACTUAL,2024-02-15,2024-03-13,ACTUAL,,,,2024-02-15,2024-03-13,ACTUAL,2021-05-17,ACTUAL,2021-05-17,2024-02,2024-02-29,2021-10-11,ACTUAL,2021-10-11,2021-10-11,ACTUAL,2021-10-11,,INTERVENTIONAL,,,Study of ST-100 as Treatment for Dry Eye Disease,"A Phase 2 Multi-Center, Randomized, Double Masked, Placebo Controlled Study to Assess the Safety and Efficacy of ST-100 Ophthalmic Solution in Subjects Diagnosed With Dry Eye Disease",COMPLETED,,PHASE2,160.0,ACTUAL,"Stuart Therapeutics, Inc.",,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,INDUSTRY,,,,,,,2021,1.0
NCT03104400,,2017-04-04,2021-12-27,2020-08-18,2024-09-16,2017-04-04,2017-04-07,ACTUAL,2021-12-27,2022-01-25,ACTUAL,2020-08-18,2020-08-25,ACTUAL,2024-09-16,2024-10-01,ACTUAL,2017-04-27,ACTUAL,2017-04-27,2024-09,2024-09-30,2024-09-09,ACTUAL,2024-09-09,2019-09-26,ACTUAL,2019-09-26,,INTERVENTIONAL,SELECT - PsA 1,The full analysis set included all randomized participants who received at least 1 dose of study drug.,A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD),"A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) - SELECT - PsA 1",COMPLETED,,PHASE3,1705.0,ACTUAL,AbbVie,,5.0,,,f,,,,t,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,INDUSTRY,,,,,,,2024,1.0
NCT02039726,,2014-01-15,2019-09-25,,2021-02-02,2014-01-16,2014-01-20,ESTIMATED,2020-01-14,2020-01-27,ACTUAL,,,,2021-02-02,2021-02-24,ACTUAL,2014-05,ACTUAL,2014-05-31,2021-02,2021-02-28,2020-09-08,ACTUAL,2020-09-08,2018-02-22,ACTUAL,2018-02-22,,INTERVENTIONAL,,Participants received standard of care salvage chemotherapy (administered subcutaneously \[LoDac\] or intravenously \[MEC and FLAG-IDA\]).,(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive,A Phase 3 Open-label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects With Tyrosine Kinase 3 - Internal Tandem Duplication (FLT3-ITD) Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation,COMPLETED,,PHASE3,367.0,ACTUAL,Daiichi Sankyo,,2.0,,,f,,,,t,,,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,INDUSTRY,,,,,,,2020,1.0
NCT05945160,,2023-07-05,,,2023-10-16,2023-07-05,2023-07-14,ACTUAL,,,,,,,2023-10-16,2023-10-18,ACTUAL,2024-01,ESTIMATED,2024-01-31,2023-10,2023-10-31,2024-12,ESTIMATED,2024-12-31,2024-08,ESTIMATED,2024-08-31,,INTERVENTIONAL,,,Vestibular Function Using Mitochondrial Antioxidant Therapy,A Randomized Controlled Study Using Alpha Lipoic Acid and CoQ-10 to Determine if Vestibular Function Can be Improved or Maintained Over the Course of One Year,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,The University of Texas Health Science Center at San Antonio,,2.0,,"Funding was terminated, the study will not enroll any subjects",f,,,,t,t,f,,,,,,At study completion when the PI publishes in a peer review journal.,,,YES,All collected deidentified IPD that underlie results in a publication,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,OTHER,,,,,,,2024,0.0
NCT04395092,,2020-05-06,,,2021-06-16,2020-05-14,2020-05-20,ACTUAL,,,,,,,2021-06-16,2021-06-22,ACTUAL,2020-11-13,ACTUAL,2020-11-13,2021-06,2021-06-30,2023-11,ESTIMATED,2023-11-30,2022-11,ESTIMATED,2022-11-30,,INTERVENTIONAL,,,Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM),Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM),WITHDRAWN,,PHASE2,0.0,ACTUAL,Kiadis Pharma,,1.0,,The sponsor decided to withdraw this study,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,INDUSTRY,,,,,,,2023,0.0
NCT04851522,,2021-04-16,,,2022-01-31,2021-04-16,2021-04-20,ACTUAL,,,,,,,2022-01-31,2022-02-15,ACTUAL,2021-06-09,ESTIMATED,2021-06-09,2022-01,2022-01-31,2023-04-01,ESTIMATED,2023-04-01,2022-04-01,ESTIMATED,2022-04-01,,INTERVENTIONAL,,,Dilute Bleach Compresses for Radiation Dermatitis,The Impact of Dilute Bleach Compresses on the Incidence and Severity of Radiation Dermatitis,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,Lack of patient accrual in the past year.,f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-16 10:59:04.412451,2024-10-16 10:59:04.412451,OTHER,,,,,,,2023,0.0
NCT01472562,,2011-03-24,2017-02-22,,2024-07-15,2011-11-10,2011-11-16,ESTIMATED,2017-02-23,2017-04-07,ACTUAL,,,,2024-07-15,2024-07-16,ACTUAL,2011-07-29,ACTUAL,2011-07-29,2024-07,2024-07-31,2023-07-30,ACTUAL,2023-07-30,2014-04,ACTUAL,2014-04-30,,INTERVENTIONAL,,,Lenalidomide Plus Rituxan for Untreated Mantle Cell Lymphoma,Phase II Study of Lenalidomide Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma,COMPLETED,,PHASE2,38.0,ACTUAL,Weill Medical College of Cornell University,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,OTHER,,,,,,,2023,1.0
NCT03118674,,2017-04-13,2023-05-05,,2023-06-14,2017-04-13,2017-04-18,ACTUAL,2023-06-14,2023-07-03,ACTUAL,,,,2023-06-14,2023-07-03,ACTUAL,2017-09-06,ACTUAL,2017-09-06,2023-05,2023-05-31,2022-03-04,ACTUAL,2022-03-04,2022-03-04,ACTUAL,2022-03-04,,INTERVENTIONAL,,Participants that started treatment,Harvoni Treatment Porphyria Cutanea Tarda,Newer Direct-Acting Anti-Viral Agents as Sole Therapy of Porphyria Cutanea Tarda in Subjects With Chronic Hepatitis C,COMPLETED,,PHASE2,23.0,ACTUAL,Wake Forest University Health Sciences,We were not able to recruit as many subjects as we had originally planned and hoped to enroll \[original target n = 49\].,1.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,OTHER,,,,,,,2022,1.0
NCT03701698,,2018-10-08,,,2024-09-27,2018-10-08,2018-10-10,ACTUAL,,,,,,,2024-09-27,2024-10-01,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2024-09,2024-09-30,2024-09-20,ACTUAL,2024-09-20,2024-09-20,ACTUAL,2024-09-20,,INTERVENTIONAL,,,Ruxolitinib and Steroid As First Line Therapy for Acute GVHD,Ruxolitinib and Methylprednisolone As First Line Therapy for Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation,TERMINATED,,PHASE2,1.0,ACTUAL,"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",,1.0,,Participants recruitment failure,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,OTHER,,,,,,,2024,0.0
NCT05008445,,2021-07-27,,,2023-03-07,2021-08-10,2021-08-17,ACTUAL,,,,,,,2023-03-07,2023-03-09,ACTUAL,2021-10-06,ACTUAL,2021-10-06,2023-03,2023-03-31,2023-02-28,ACTUAL,2023-02-28,2023-02-08,ACTUAL,2023-02-08,,INTERVENTIONAL,,,Study of LM-102 in Patients With Advance Solid Tumors,"A Phase I/II, Open-Label, Multiple Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-102 Monotherapy or Combination Therapy in Patients With CLDN18.2-Positive Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,11.0,ACTUAL,LaNova Medicines Limited,,7.0,,company adjusted strategy,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,INDUSTRY,,,,,,,2023,0.0
NCT04683939,,2020-12-21,2024-07-18,,2024-09-06,2020-12-21,2020-12-24,ACTUAL,2024-09-06,2024-10-02,ACTUAL,,,,2024-09-06,2024-10-02,ACTUAL,2022-01-18,ACTUAL,2022-01-18,2024-09,2024-09-30,2023-07-24,ACTUAL,2023-07-24,2023-07-24,ACTUAL,2023-07-24,,INTERVENTIONAL,,"Safety Set - All patients who received investigational medicinal product (IMP) (i.e., at least one dose of BNT141)","Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors","Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT141 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With CLDN18.2-positive Solid Tumors",TERMINATED,,PHASE1/PHASE2,13.0,ACTUAL,BioNTech SE,,3.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,INDUSTRY,,,,,,,2023,0.0
NCT03339973,,2017-10-11,,,2020-06-25,2017-11-09,2017-11-13,ACTUAL,,,,,,,2020-06-25,2020-06-29,ACTUAL,2018-03-05,ACTUAL,2018-03-05,2020-06,2020-06-30,2020-05-15,ACTUAL,2020-05-15,2020-05-15,ACTUAL,2020-05-15,,INTERVENTIONAL,,,Allogeneic ABCB5-positive Stem Cells for Treatment of PAOD,"A Randomised, Placebo-controlled, Double-blind, Interventional, Multicenter, Phase I/IIa Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-PAOD for the Treatment of Peripheral Arterial Occlusive Disease (PAOD)",TERMINATED,,PHASE1/PHASE2,24.0,ACTUAL,RHEACELL GmbH & Co. KG,,2.0,,Very slow recruitment of patients and the current COVID-19 pandemic situation.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,INDUSTRY,,,,,,,2020,0.0
NCT02951429,,2016-10-28,2020-08-18,,2020-10-20,2016-10-28,2016-11-01,ESTIMATED,2020-10-20,2020-11-12,ACTUAL,,,,2020-10-20,2020-11-12,ACTUAL,2016-12-31,ACTUAL,2016-12-31,2020-10,2020-10-31,2020-08-22,ACTUAL,2020-08-22,2019-09-26,ACTUAL,2019-09-26,,INTERVENTIONAL,,ITT Population -,"Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension","A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients With Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Group 3 Pulmonary Hypertension",COMPLETED,,PHASE2,177.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,INDUSTRY,,,,,,,2020,1.0
NCT03442985,,2017-10-11,2021-08-19,2020-10-23,2022-07-07,2018-02-21,2018-02-22,ACTUAL,2022-07-07,2022-08-01,ACTUAL,2022-07-07,2022-08-01,ACTUAL,2022-07-07,2022-08-01,ACTUAL,2018-03-22,ACTUAL,2018-03-22,2022-07,2022-07-31,2020-10-30,ACTUAL,2020-10-30,2020-03-24,ACTUAL,2020-03-24,,INTERVENTIONAL,MO-Ped,The Safety set included randomized participants who received at least 1 dose of study drug.,An Efficacy and Safety Study of Palovarotene for the Treatment of MO,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Palovarotene in Subjects With Multiple Osteochondromas",TERMINATED,,PHASE2,193.0,ACTUAL,Ipsen,"The Sponsor terminated the study early due to a partial clinical hold instituted by the Food and Drug Administration. Recruitment was stopped before full enrollment was reached, and study drug administration was discontinued.",3.0,,"Trial was terminated early to analyze the accumulated data and evaluate the efficacy, safety and future of palovarotene in MO.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,INDUSTRY,,,,,,,2020,0.0
NCT02446886,,2015-05-07,2020-12-04,,2020-12-31,2015-05-15,2015-05-18,ESTIMATED,2020-12-31,2021-01-22,ACTUAL,,,,2020-12-31,2021-01-22,ACTUAL,2016-06,ACTUAL,2016-06-30,2020-12,2020-12-31,2020-06,ACTUAL,2020-06-30,2020-03,ACTUAL,2020-03-31,,INTERVENTIONAL,,,Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS,Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS,TERMINATED,,PHASE4,15.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,Slow enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,OTHER,,,,,,,2020,0.0
NCT05619536,,2022-11-09,2024-06-24,,2024-06-24,2022-11-09,2022-11-17,ACTUAL,2024-06-24,2024-10-01,ACTUAL,,,,2024-06-24,2024-10-01,ACTUAL,2022-10-18,ACTUAL,2022-10-18,2024-06,2024-06-30,2023-07-14,ACTUAL,2023-07-14,2023-07-14,ACTUAL,2023-07-14,,INTERVENTIONAL,,The Safety Population analyzed consisted of all participants who received any amount of study drug.,Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects,"A Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD388 Subcutaneous Administration in Healthy Japanese Subjects",COMPLETED,,PHASE1,28.0,ACTUAL,Cidara Therapeutics Inc.,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,INDUSTRY,,,,,,,2023,1.0
NCT04158674,,2019-11-07,,,2024-09-27,2019-11-07,2019-11-12,ACTUAL,,,,,,,2024-09-27,2024-10-01,ACTUAL,2020-02-24,ACTUAL,2020-02-24,2024-09,2024-09-30,2023-10-11,ACTUAL,2023-10-11,2023-10-11,ACTUAL,2023-10-11,,INTERVENTIONAL,Weanilevo,,Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS,"Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS. Randomized, Controlled, Multicenter, Double-blind, Multicenter Clinical Trial",TERMINATED,,PHASE3,82.0,ACTUAL,Centre Hospitalier Universitaire Dijon,,2.0,,There was insufficient funding to continue the study in good conditions.,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,OTHER,,,,,,,2023,0.0
NCT02101034,,2014-03-27,2021-04-15,,2023-12-20,2014-03-27,2014-04-01,ESTIMATED,2021-05-17,2021-06-11,ACTUAL,,,,2023-12-20,2023-12-21,ACTUAL,2014-06-17,ACTUAL,2014-06-17,2023-12,2023-12-31,2023-11-10,ACTUAL,2023-11-10,2020-06-08,ACTUAL,2020-06-08,,INTERVENTIONAL,,,PD 0332991 and Cetuximab in Patients With Incurable SCCHN,Phase I/II Trial of the Addition of PD 0332991 to Cetuximab in Patients With Incurable SCCHN,COMPLETED,,PHASE1/PHASE2,96.0,ACTUAL,Washington University School of Medicine,,5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,OTHER,,,,,,,2023,1.0
NCT03658213,,2018-06-27,,,2021-05-06,2018-09-04,2018-09-05,ACTUAL,,,,,,,2021-05-06,2021-05-10,ACTUAL,2020-03-31,ESTIMATED,2020-03-31,2021-04,2021-04-30,2021-11-04,ESTIMATED,2021-11-04,2021-11-04,ESTIMATED,2021-11-04,,INTERVENTIONAL,LARES,,To Compare ZOLADEX 10.8 mg With ZOLADEX 3.6mg in Chinese Pre-menopausal ER+ HER2- Early Breast Cancer.,"An Open Label, Randomised, Parallel Group, Multicentre, Non-inferiority Study to Compare ZOLADEX 10.8 mg With ZOLADEX 3.6 mg in Chinese Pre-menopausal Patients With Estrogen Receptor-Positive and HER2 Negative Early Breast Cancer",WITHDRAWN,,PHASE3,0.0,ACTUAL,AstraZeneca,,2.0,,"CTP of LARES has been out of the expire date, we are trying RWS pathway for the indication expend",f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,INDUSTRY,,,,,,,2021,0.0
NCT04612790,,2020-10-12,,,2023-11-17,2020-10-27,2020-11-03,ACTUAL,,,,,,,2023-11-17,2023-11-18,ACTUAL,2021-03-31,ACTUAL,2021-03-31,2023-11,2023-11-30,2023-10-26,ACTUAL,2023-10-26,2023-10-26,ACTUAL,2023-10-26,,INTERVENTIONAL,FJORD,,A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid.,"A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab as a Treatment Option for Patients With Bullous Pemphigoid (FJORD)",TERMINATED,,PHASE3,67.0,ACTUAL,AstraZeneca,,2.0,,Independent Data Monitoring Committee recommended terminating the study following a pre-planned analysis as the efficacy results did not meet the pre-defined futility guidelines. There were no new safety concerns identified from this analysis.,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,INDUSTRY,,,,,,,2023,0.0
NCT03331861,,2017-11-01,2022-08-20,,2024-07-17,2017-11-01,2017-11-06,ACTUAL,2024-07-17,2024-07-18,ACTUAL,,,,2024-07-17,2024-07-18,ACTUAL,2019-02-15,ACTUAL,2019-02-15,2024-07,2024-07-31,2021-08-20,ACTUAL,2021-08-20,2021-08-20,ACTUAL,2021-08-20,,INTERVENTIONAL,Met-HeFT,,Metformin in Heart Failure Without Diabetes,Metformin in Heart Failure Without Diabetes,TERMINATED,,PHASE2,6.0,ACTUAL,Columbia University,"Study was terminated early, data was unblinded but not analyzed due to low enrollment and lack of statistical power.",2.0,,Lack of funding,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2021,0.0
NCT02707523,,2016-02-20,2020-05-08,2020-04-23,2020-07-07,2016-03-11,2016-03-14,ESTIMATED,2020-05-08,2020-05-27,ACTUAL,2020-04-23,2020-04-28,ACTUAL,2020-07-07,2020-07-22,ACTUAL,2016-01-01,ACTUAL,2016-01-01,2020-07,2020-07-31,2020-06-20,ACTUAL,2020-06-20,2019-02-06,ACTUAL,2019-02-06,,INTERVENTIONAL,,,Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children,Prospective Pilot Clinical Trial of Azithromycin Treatment In RSV-induced Respiratory Failure In Children,COMPLETED,,PHASE2,48.0,ACTUAL,University of Alabama at Birmingham,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,OTHER,,,,,,,2020,1.0
NCT04383938,,2020-05-07,,,2022-06-01,2020-05-11,2020-05-12,ACTUAL,,,,,,,2022-06-01,2022-06-03,ACTUAL,2020-06-25,ACTUAL,2020-06-25,2022-06,2022-06-30,2022-04-30,ACTUAL,2022-04-30,2022-04-30,ACTUAL,2022-04-30,,INTERVENTIONAL,,,Phase 1/2 Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies,Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies,COMPLETED,,PHASE1/PHASE2,37.0,ACTUAL,Aprea Therapeutics,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,INDUSTRY,,,,,,,2022,1.0
NCT01258075,,2010-12-09,2020-11-25,,2021-04-16,2010-12-09,2010-12-10,ESTIMATED,2020-11-25,2020-12-22,ACTUAL,,,,2021-04-16,2021-05-13,ACTUAL,2011-02-24,ACTUAL,2011-02-24,2021-04,2021-04-30,2020-04-21,ACTUAL,2020-04-21,2019-11-01,ACTUAL,2019-11-01,,INTERVENTIONAL,WELKid DM,Baseline demographic characteristics were assessed in the Randomized Set.,Colesevelam for Children With Type 2 Diabetes,Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus,COMPLETED,,PHASE4,236.0,ACTUAL,Daiichi Sankyo,,2.0,,,f,,,,t,t,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,INDUSTRY,,,,,,,2020,1.0
NCT04186299,,2019-11-21,,,2023-04-07,2019-12-03,2019-12-04,ACTUAL,,,,,,,2023-04-07,2023-04-10,ACTUAL,2021-08,ESTIMATED,2021-08-31,2023-04,2023-04-30,2022-12,ESTIMATED,2022-12-31,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,,,The Effect of Buccal Infiltration Administration of Clonidine on the Success Rate of Inferior Alveolar Nerve Block,The Effect of Buccal Infiltration Administration of Clonidine on the Success Rate of Inferior Alveolar Nerve Block on Mandibular Molars With Symptomatic Irreversible Pulpitis: a Randomized Double-blind Clinical Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of California, San Francisco",,2.0,,Study activities never commenced.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,OTHER,,,,,,,2022,0.0
NCT05251038,,2022-02-11,,,2023-05-10,2022-02-11,2022-02-22,ACTUAL,,,,,,,2023-05-10,2023-05-11,ACTUAL,2022-09-13,ACTUAL,2022-09-13,2023-02,2023-02-28,2023-01-31,ACTUAL,2023-01-31,2023-01-31,ACTUAL,2023-01-31,,INTERVENTIONAL,,,Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer,A Phase Ib/II Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of KRAS p. G12C Mutated Advanced Pancreatic Cancer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Hoosier Cancer Research Network,,1.0,,Funder Decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,OTHER,,,,,,,2023,0.0
NCT04787250,,2021-02-18,,,2022-03-22,2021-03-05,2021-03-08,ACTUAL,,,,,,,2022-03-22,2022-04-04,ACTUAL,2022-10,ESTIMATED,2022-10-31,2022-03,2022-03-31,2024-05,ESTIMATED,2024-05-31,2023-05,ESTIMATED,2023-05-31,,INTERVENTIONAL,,,Bacteriophage Therapy in Patients With Prosthetic Joint Infections,"Randomized Open Label, Parallel Group, Controlled Study to Evaluate the Safety and Surgery Sparing Effect of Phage Therapy With Antibiotics for Patients With Prosthetic Joint Infections Who Are Candidates for Two Stage Exchange Arthroplasty",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Adaptive Phage Therapeutics, Inc.",,2.0,,Changes to protocol design,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,INDUSTRY,,,,,,,2024,0.0
NCT04394650,,2020-05-14,,,2024-07-24,2020-05-14,2020-05-19,ACTUAL,,,,,,,2024-07-24,2024-07-26,ACTUAL,2020-08-18,ACTUAL,2020-08-18,2024-07,2024-07-31,2024-07-03,ACTUAL,2024-07-03,2024-07-03,ACTUAL,2024-07-03,,INTERVENTIONAL,,,"A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma","A Phase I, Multi Center, Open Label Study of CC-98633, BCMA Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed and/or Refractory Multiple Myeloma",COMPLETED,,PHASE1,78.0,ACTUAL,"Juno Therapeutics, a Subsidiary of Celgene",,1.0,,,f,,,,t,t,f,,,,,,See Plan Description,See Plan Description,https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,INDUSTRY,,,,,,,2024,1.0
NCT04826133,,2021-03-24,,,2023-08-07,2021-03-30,2021-04-01,ACTUAL,,,,,,,2023-08-07,2023-08-14,ACTUAL,2019-03-27,ACTUAL,2019-03-27,2023-08,2023-08-31,2020-01-17,ACTUAL,2020-01-17,2020-01-17,ACTUAL,2020-01-17,,INTERVENTIONAL,,,Vitamin D and Cocaine Administration,Testing Restoring Effects of Vitamin D on the Dopamine System: A Human Laboratory Study Among Cocaine Users.,TERMINATED,,EARLY_PHASE1,4.0,ACTUAL,Yale University,,2.0,,Could not obtain additional funding to continue the research.,f,,,,,t,f,,,,,,,,,,,2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,OTHER,,,,,,,2020,0.0
NCT01967927,,2013-10-18,,,2021-08-17,2013-10-18,2013-10-23,ESTIMATED,,,,,,,2021-08-17,2021-08-19,ACTUAL,2013-12,,2013-12-31,2021-08,2021-08-31,2021-08-17,ACTUAL,2021-08-17,2021-08-17,ACTUAL,2021-08-17,,INTERVENTIONAL,,,Understanding GRID Radiation Therapy Effects on Human Tumor Oxygenation and Interstitial Pressure to Increase Translation of Solid Tumor Therapy,Understanding GRID Radiation Therapy Effects on Human Tumor Oxygenation and Interstitial Pressure to Increase Translation of Solid Tumor Therapy,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Arkansas,,1.0,,Study has been open for 8 years with no enrollment. Procedures in 2013 protocol are outdated. Cannot make the radiopharmaceutical on campus anymore.,f,,,,t,,,,,,,,,,,,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,OTHER,,,,,,,2021,0.0
NCT05008835,,2021-08-10,,,2022-10-12,2021-08-10,2021-08-17,ACTUAL,,,,,,,2022-10-12,2022-10-14,ACTUAL,2021-07-20,ACTUAL,2021-07-20,2022-10,2022-10-31,2022-09-08,ACTUAL,2022-09-08,2022-08-12,ACTUAL,2022-08-12,,INTERVENTIONAL,,,Evaluate the Efficacy and Safety of ACP-044 in Subjects With Pain Associated With Osteoarthritis of the Knee,"A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ACP-044 in Subjects With Pain Associated With Osteoarthritis of the Knee",TERMINATED,,PHASE2,61.0,ACTUAL,ACADIA Pharmaceuticals Inc.,,3.0,,Study was terminated for business reasons.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,INDUSTRY,,,,,,,2022,0.0
NCT04930042,,2021-01-19,,,2023-02-01,2021-06-10,2021-06-18,ACTUAL,,,,,,,2023-02-01,2023-02-02,ACTUAL,2021-06-03,ACTUAL,2021-06-03,2022-05,2022-05-31,2022-10-11,ACTUAL,2022-10-11,2021-12-28,ACTUAL,2021-12-28,,INTERVENTIONAL,,,"Efficacy, Safety, and Immunogenicity of AVT04 With Moderate-to-Severe Chronic Plaque Psoriasis","A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Ustekinumab (AVT04) and Stelara® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis",COMPLETED,,PHASE3,581.0,ACTUAL,Alvotech Swiss AG,,2.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,INDUSTRY,,,,,,,2022,1.0
NCT04586335,,2020-08-25,,,2024-03-20,2020-10-07,2020-10-14,ACTUAL,,,,,,,2024-03-20,2024-03-21,ACTUAL,2020-09-28,ACTUAL,2020-09-28,2024-03,2024-03-31,2023-02-15,ACTUAL,2023-02-15,2023-02-15,ACTUAL,2023-02-15,,INTERVENTIONAL,,,Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.,"Open Label, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of CYH33, an Oral PI3K Inhibitor in Combination With Olaparib, an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.",TERMINATED,,PHASE1,24.0,ACTUAL,"Haihe Biopharma Co., Ltd.",,1.0,,Business decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,INDUSTRY,,,,,,,2023,0.0
NCT02808143,,2016-05-25,2022-07-27,,2024-06-05,2016-06-20,2016-06-21,ESTIMATED,2022-09-27,2022-10-20,ACTUAL,,,,2024-06-05,2024-06-26,ACTUAL,2017-02-10,ACTUAL,2017-02-10,2024-06,2024-06-30,2022-08-05,ACTUAL,2022-08-05,2020-05-15,ACTUAL,2020-05-15,,INTERVENTIONAL,,,Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer,A Phase 1 Dose-Escalation Study of Intravesical MK-3475 and Bacillus Calmette-Guerin (BCG) in Subjects With High Risk and BCG-Refractory Non-Muscle-Invasive Bladder Cancer,COMPLETED,,PHASE1,9.0,ACTUAL,Northwestern University,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,OTHER,,,,,,,2022,1.0
NCT03554798,,2018-05-08,2022-01-20,,2023-04-18,2018-06-12,2018-06-13,ACTUAL,2022-01-20,2022-03-23,ACTUAL,,,,2023-04-18,2024-01-19,ACTUAL,2018-12-04,ACTUAL,2018-12-04,2023-04,2023-04-30,2020-02-19,ACTUAL,2020-02-19,2020-02-19,ACTUAL,2020-02-19,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Immunogenicity of Novel Oral Polio Vaccine,A Phase 2 Study to Evaluate the Safety and Immunogenicity of Two Novel Oral Polio Type 2 (nOPV2) Vaccine Candidates in Healthy Children Aged 1 to 5 Years and in Healthy Bivalent Oral Polio Vaccine-inactivated Polio Vaccine (bOPV-IPV) Vaccinated Infants,COMPLETED,,PHASE2,1025.0,ACTUAL,Fidec Corporation,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,OTHER,,,,,,,2020,1.0
NCT02508324,,2015-04-07,2024-01-19,,2024-01-19,2015-07-22,2015-07-24,ESTIMATED,2024-01-19,2024-02-13,ACTUAL,,,,2024-01-19,2024-02-13,ACTUAL,2015-09-10,ACTUAL,2015-09-10,2024-01,2024-01-31,2022-06-24,ACTUAL,2022-06-24,2022-06-24,ACTUAL,2022-06-24,,INTERVENTIONAL,,No subjects were enrolled onto the Haploidentical arm due to graft selection criteria and suitable cord blood units being identified for subjects.,IPA Targeted Adoptive Immunotherapy vs Adult Haplo-identical Cell Infusion During Induction of High Risk Leukemia,Parallel Phase II Trial of IPA Targeted Adoptive Immunotherapy vs Adult Haplo-identical Cell Infusion During Induction of High Risk Leukemia,TERMINATED,,PHASE2,43.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,Slow accrual and change in direction of cord blood program,f,,,,f,t,f,,,,,,,,,,,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,OTHER,,,,,,,2022,0.0
NCT02936037,,2016-10-14,2020-10-29,,2020-10-29,2016-10-14,2016-10-18,ESTIMATED,2020-10-29,2020-11-23,ACTUAL,,,,2020-10-29,2020-11-23,ACTUAL,2016-12,ACTUAL,2016-12-31,2020-10,2020-10-31,2020-04-23,ACTUAL,2020-04-23,2019-11-15,ACTUAL,2019-11-15,,INTERVENTIONAL,SPI2,,Effect of MD1003 in Progressive Multiple Sclerosis (SPI2),Effect of MD1003 in Progressive Multiple Sclerosis: a Randomized Double Blind Placebo Controlled Study,TERMINATED,,PHASE3,642.0,ACTUAL,MedDay Pharmaceuticals SA,,2.0,,Sponsor decision for business purposes,f,,,,t,,,,,,,,,,,NO,,2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,INDUSTRY,,,,,,,2020,0.0
NCT04211415,,2019-12-23,,,2021-06-16,2019-12-23,2019-12-26,ACTUAL,,,,,,,2021-06-16,2021-06-22,ACTUAL,2020-01-13,ACTUAL,2020-01-13,2021-06,2021-06-30,2020-12-18,ACTUAL,2020-12-18,2020-03-14,ACTUAL,2020-03-14,,INTERVENTIONAL,,,Phase I Study of DS-2741a in Healthy Volunteers and Participants With Atopic Dermatitis,"DS-2741a Phase I Study- A Three-part First-in-human Study: Single Ascending Dose and Multiple Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DS-2741a After Subcutaneous Injection in Healthy Japanese Male Subjects, and Single Dose Study to Assess the Pharmacokinetics, Safety, Pharmacodynamics and Efficacy of DS-2741a After Subcutaneous Injection in Japanese Subjects With Moderate to Severe Atopic Dermatitis.",TERMINATED,,PHASE1,8.0,ACTUAL,Daiichi Sankyo,,11.0,,Company decision of termination of the clinical program.,f,,,,f,f,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://www.vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,INDUSTRY,,,,,,,2020,0.0
NCT02794168,,2016-05-31,,,2021-10-06,2016-06-07,2016-06-08,ESTIMATED,,,,,,,2021-10-06,2021-10-11,ACTUAL,2016-06,ACTUAL,2016-06-30,2021-10,2021-10-31,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,NOSTRA-III,,Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain Injury,"Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain Injury - (NOSTRA Phase III Trial): A Confirmatory, Placebo-controlled, Randomised, Double Blind, Multi-centre Study",COMPLETED,,PHASE3,224.0,ACTUAL,veriNOS operations GmbH,,2.0,,,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,INDUSTRY,,,,,,,2020,0.0
NCT02705339,,2016-01-12,,,2016-05-16,2016-03-04,2016-03-10,ESTIMATED,,,,,,,2016-05-16,2016-05-17,ESTIMATED,2016-05,,2016-05-31,2016-05,2016-05-31,2020-04,ESTIMATED,2020-04-30,2019-11,ESTIMATED,2019-11-30,,INTERVENTIONAL,,,Rociletinib Genomic Landscape in Non-small Cell Lung Cancer (NSCLC),Genomic Landscape of EGFR Mutant NSCLC Prior to Rociletinib and at the Time of Disease Progression Following Rociletinib,WITHDRAWN,,PHASE2,0.0,ACTUAL,Washington University School of Medicine,,1.0,,Clovis Oncology discontinued rociletinib.,f,,,,f,,,,,,,,,,,NO,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,OTHER,,,,,,,2020,0.0
NCT03740724,,2018-11-06,2022-05-20,,2024-01-04,2018-11-09,2018-11-14,ACTUAL,2022-06-16,2022-06-24,ACTUAL,,,,2024-01-04,2024-01-23,ACTUAL,2019-12-18,ACTUAL,2019-12-18,2024-01,2024-01-31,2022-04-21,ACTUAL,2022-04-21,2020-09-23,ACTUAL,2020-09-23,,INTERVENTIONAL,,,A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea),A Phase 1/2 Study of a Combination of FCX-013 (Genetically-Modified Autologous Human Dermal Fibroblasts) Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea),TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,"Castle Creek Biosciences, LLC.",,1.0,,Sponsor decision,,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,INDUSTRY,,,,,,,2022,0.0
NCT02947269,,2016-10-23,,,2021-09-27,2016-10-25,2016-10-27,ESTIMATED,,,,,,,2021-09-27,2021-09-29,ACTUAL,2017-10-25,ACTUAL,2017-10-25,2021-09,2021-09-30,2020-08-30,ACTUAL,2020-08-30,2020-08-30,ACTUAL,2020-08-30,,INTERVENTIONAL,,,Prucalopride in Postoperative Ileus,A Randomized Double-blind Placebo Controlled Trial of Prucalopride to Reduce the Duration of Postoperative Ileus in Patients Undergoing Elective Colorectal Surgery,COMPLETED,,PHASE3,150.0,ACTUAL,"University of Auckland, New Zealand",,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,OTHER,,,,,,,2020,0.0
NCT02237638,,2014-08-15,,,2021-04-14,2014-09-09,2014-09-11,ESTIMATED,,,,,,,2021-04-14,2021-04-19,ACTUAL,2014-04,,2014-04-30,2021-04,2021-04-30,2020-01-01,ACTUAL,2020-01-01,2020-01,ACTUAL,2020-01-31,,INTERVENTIONAL,,,Phase I Study on VEGF Vaccination in Metastatic Solid Tumors,"A Phase I Open-label Clinical Trial, Evaluating the Therapeutic Vaccine hVEGF26-104/RFASE in Patients With Advanced Solid Tumors",COMPLETED,,PHASE1,30.0,ACTUAL,"Amsterdam UMC, location VUmc",,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,OTHER,,,,,,,2020,0.0
NCT02052882,,2014-01-30,,,2023-11-13,2014-01-30,2014-02-03,ESTIMATED,,,,,,,2023-11-13,2023-11-14,ACTUAL,2014-01-30,ACTUAL,2014-01-30,2023-11,2023-11-30,2023-11-13,ACTUAL,2023-11-13,2023-11-13,ACTUAL,2023-11-13,,INTERVENTIONAL,,,Study of Romiplostim for Chemotherapy Induced Thrombocytopenia,An Open Label Phase II Study of Romiplostim for Chemotherapy Induced Thrombocytopenia,COMPLETED,,PHASE2,60.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,OTHER,,,,,,,2023,1.0
NCT04420585,,2020-05-21,2024-02-22,,2024-04-10,2020-06-04,2020-06-09,ACTUAL,2024-04-10,2024-05-07,ACTUAL,,,,2024-04-10,2024-05-07,ACTUAL,2020-07-07,ACTUAL,2020-07-07,2024-04,2024-04-30,2023-06-12,ACTUAL,2023-06-12,2023-06-12,ACTUAL,2023-06-12,,INTERVENTIONAL,,,Desmopressin for Bedwetting in Children With SCD,Desmopressin as a Therapy for Nocturnal Enuresis in Pediatric Patients With Sickle Cell Disease,TERMINATED,,PHASE4,8.0,ACTUAL,Montefiore Medical Center,,1.0,,Study was not able to meet recruitment after 9 years of trying to enroll patients on different versions of the protocol and changing recruitment strategies.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,OTHER,,,,,,,2023,0.0
NCT04794205,,2021-03-03,,,2021-10-26,2021-03-09,2021-03-11,ACTUAL,,,,,,,2021-10-26,2021-11-02,ACTUAL,2021-09,ESTIMATED,2021-09-30,2021-10,2021-10-31,2022-04,ESTIMATED,2022-04-30,2022-04,ESTIMATED,2022-04-30,,INTERVENTIONAL,BCP-Pain,,Acute Changes In Thermal Pain Response Following Single Oral Dose of Beta-Cary,Acute Changes In Thermal Pain Response Following Single Oral Dose of Beta-Cary,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Hartford Hospital,,4.0,,Delayed project onset; PI determined pilot data could be collected at a later date.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,OTHER,,,,,,,2022,0.0
NCT05520970,,2022-06-20,,,2023-06-20,2022-08-27,2022-08-30,ACTUAL,,,,,,,2023-06-20,2023-06-22,ACTUAL,2022-08-19,ACTUAL,2022-08-19,2023-06,2023-06-30,2022-11-08,ACTUAL,2022-11-08,2022-11-08,ACTUAL,2022-11-08,,INTERVENTIONAL,,,"Safety and Immunogenicity of COVID-19 Vaccine, AdCLD-CoV19-1","A Phase IIb, Multicenter, Observer-Blinded, Randomized, Placebo-Controlled Trial to Evaluate the Immunogenicity and Safety of the AdCLD-CoV19-1 in Healthy Adults Aged 19 Years Old and Above",TERMINATED,,PHASE2,4.0,ACTUAL,"Cellid Co., Ltd.",,3.0,,Study early terminated based on the sponsor(manufacture)'s decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,INDUSTRY,,,,,,,2022,0.0
NCT03409107,,2018-01-08,2021-10-05,,2024-04-01,2018-01-17,2018-01-24,ACTUAL,2021-10-05,2021-11-03,ACTUAL,,,,2024-04-01,2024-04-02,ACTUAL,2018-03-05,ACTUAL,2018-03-05,2024-03,2024-03-31,2020-10-07,ACTUAL,2020-10-07,2020-10-07,ACTUAL,2020-10-07,,INTERVENTIONAL,,,Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ),"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naïve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",COMPLETED,,PHASE3,614.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,f,t,f,,,,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://www.gsk.com/en-gb/innovation/trials/data-transparency,YES,Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/,2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,INDUSTRY,,,,,,,2020,1.0
NCT04662528,,2020-12-04,,,2021-09-09,2020-12-04,2020-12-10,ACTUAL,,,,,,,2021-09-09,2021-09-16,ACTUAL,2021-06,ESTIMATED,2021-06-30,2021-09,2021-09-30,2022-10,ESTIMATED,2022-10-31,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,AMPLIFY,,Safety and Efficacy of MAT9001(Omega-3-pentaenoic Acid) in Subjects With Triglycerides ≥500 mg/dL and <2000 mg/dL,"A Phase 3, Placebo-Controlled, Randomized, Double-blind, Parallel-arm Trial to Assess the Safety and Efficacy of MAT9001 in Subjects With Severe Hypertriglyceridemia: The AMPLIFY Trial",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Matinas Biopharma, Inc",,2.0,,suspended,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,INDUSTRY,,,,,,,2022,0.0
NCT02948959,,2016-10-27,2021-08-24,,2022-03-15,2016-10-27,2016-10-31,ESTIMATED,2021-10-06,2021-10-20,ACTUAL,,,,2022-03-15,2022-03-28,ACTUAL,2017-04-21,ACTUAL,2017-04-21,2022-03,2022-03-31,2020-08-26,ACTUAL,2020-08-26,2020-08-26,ACTUAL,2020-08-26,,INTERVENTIONAL,VOYAGE,Analysis was performed on intent to treat population which included all randomized participants.,Evaluation of Dupilumab in Children With Uncontrolled Asthma,"A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Children 6 to <12 Years of Age With Uncontrolled Persistent Asthma",COMPLETED,,PHASE3,408.0,ACTUAL,Sanofi,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,INDUSTRY,,,,,,,2020,1.0
NCT03207542,,2017-06-30,,,2018-07-23,2017-06-30,2017-07-02,ACTUAL,,,,,,,2018-07-23,2018-07-26,ACTUAL,2018-07,ESTIMATED,2018-07-31,2018-07,2018-07-31,2021-07,ESTIMATED,2021-07-31,2020-07,ESTIMATED,2020-07-31,,INTERVENTIONAL,,,Trial Evaluating the Efficacy and Safety of Daratumumab in Subjects With Relapsed/Refractory B-cell or T-cell Precursor Acute Lymphoblastic Leukemia (ALL),An Open-label Phase 2 Trial Evaluating the Efficacy and Safety of Daratumumab in Subjects With Relapsed/Refractory B-cell or T-cell Precursor Acute Lymphoblastic Leukemia (ALL),WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,PI request,f,,,,f,t,f,,,,,,,,,,,2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,OTHER,,,,,,,2021,0.0
NCT06137651,,2023-11-14,,,2024-03-28,2023-11-14,2023-11-18,ACTUAL,,,,,,,2024-03-28,2024-04-01,ACTUAL,2023-12-31,ESTIMATED,2023-12-31,2024-03,2024-03-31,2024-03-27,ACTUAL,2024-03-27,2024-03-27,ACTUAL,2024-03-27,,INTERVENTIONAL,,,Trotabresib in Combination With Vinorelbine and Radiation Therapy for the Treatment of HER2+ Breast Cancer With Central Nervous System or Leptomeningeal Metastasis,"A Phase I/Ib Trial of Trotabresib (BMS-986378), an Oral BET Inhibitor) in Combination With Vinorelbine and Radiation Therapy in HER2+ Breast Cancer Patients With Central Nervous System Metastasis and Leptomeningeal Disease (CA076-1008)",WITHDRAWN,,PHASE1,0.0,ACTUAL,Northwestern University,,2.0,,Study terminated by the sponsor,,,,,t,t,f,,,f,,,,,,,,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,OTHER,,,,,,,2024,0.0
NCT05977127,,2023-08-03,,,2024-03-26,2023-08-03,2023-08-04,ACTUAL,,,,,,,2024-03-26,2024-03-28,ACTUAL,2023-09-26,ACTUAL,2023-09-26,2024-03,2024-03-31,2024-03-21,ACTUAL,2024-03-21,2024-03-21,ACTUAL,2024-03-21,,INTERVENTIONAL,HVaNa,,Intradermal Administration of a COVID-19 mRNA Vaccine in Elderly,Intradermal Administration of a COVID-19 mRNA Vaccine in Elderly,TERMINATED,,PHASE2,48.0,ACTUAL,Radboud University Medical Center,,3.0,,Recruitment rate dropped because of national COVID-19 vaccination campaign taking place parallel to this study.,f,,,,f,f,f,,,f,,,,,,UNDECIDED,,2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,OTHER,,,,,,,2024,0.0
NCT04743804,,2021-01-28,2023-11-21,,2024-09-16,2021-02-04,2021-02-08,ACTUAL,2023-11-21,2023-12-12,ACTUAL,,,,2024-09-16,2024-10-01,ACTUAL,2021-06-29,ACTUAL,2021-06-29,2024-08,2024-08-31,2022-12-22,ACTUAL,2022-12-22,2022-12-22,ACTUAL,2022-12-22,,INTERVENTIONAL,,"The Modified Intent-to-Treat Analysis Set included all randomized participants, excluding participants who enrolled prior to availability of ST-HUS and ADAMTS13 central laboratory results and were subsequently found to be ineligible after randomization.",Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger,"A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants Who Have Thrombotic Microangiopathy Associated With a Trigger",TERMINATED,,PHASE3,16.0,ACTUAL,"Alexion Pharmaceuticals, Inc.","Due to continued enrollment challenges, Alexion decided to terminate this study prematurely. There were no safety or efficacy concerns throughout the course of study. The planned interim analysis for sample size re-estimation and the planned primary analysis as specified in Protocol Amendment 2 were not conducted due to early termination of the study. No hypothesis testing or inferential statistical analysis for the purpose of treatment comparisons was performed due to small sample size.",2.0,,Recruitment Challenges,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,INDUSTRY,,,,,,,2022,0.0
NCT03021954,,2017-01-11,2022-03-22,,2023-07-06,2017-01-12,2017-01-16,ESTIMATED,2023-07-06,2024-01-29,ACTUAL,,,,2023-07-06,2024-01-29,ACTUAL,2016-11,ACTUAL,2016-11-30,2023-07,2023-07-31,2020-01,ACTUAL,2020-01-31,2019-01,ACTUAL,2019-01-31,,INTERVENTIONAL,,,Platelet Rich Plasma in Levator Ani Muscle Trauma,The Role of Platelet Rich Plasma in Supporting the Recovery of Post-partum Levator Ani Muscle Trauma,COMPLETED,,PHASE2/PHASE3,116.0,ACTUAL,Dr Cipto Mangunkusumo General Hospital,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,OTHER,,,,,,,2020,1.0
NCT02822573,,2016-06-30,2023-07-24,,2023-08-17,2016-06-30,2016-07-04,ESTIMATED,2023-08-17,2023-09-13,ACTUAL,,,,2023-08-17,2023-09-13,ACTUAL,2017-05-30,ACTUAL,2017-05-30,2023-07,2023-07-31,2022-07-29,ACTUAL,2022-07-29,2022-07-29,ACTUAL,2022-07-29,,INTERVENTIONAL,Remember,All participants that were enrolled and randomized completed baseline assessments.,Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil,A Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil in Chemotherapy Exposed Breast Cancer Survivors With Cognitive Impairment,COMPLETED,,PHASE3,276.0,ACTUAL,Wake Forest University Health Sciences,"Our mainly non-Hispanic, white sample of breast cancer survivors, while geographically diverse, is not representative of all survivors. A lack of validated alternate forms of most of our tests may have contributed to a practice effect. We did not collect estrogen receptor, progesterone receptor or human epidermal growth factor receptor 2 (HER2) status.",2.0,,,f,,,,t,t,f,,,,,,See NIH Policy,request using link below,https://nctn-data-archive.nci.nih.gov/,YES,"Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base is committed to following the NIH Statement on Sharing Research Data. As of July 2018, the Wake Forest (WF) NCORP Research Base (RB) signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI National Clinical Trials Network (NCTN)/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide.",2024-10-16 22:52:59.705207,2024-10-16 22:52:59.705207,OTHER,,,,,,,2022,1.0
NCT04844918,,2021-04-01,2024-06-20,,2024-06-20,2021-04-12,2021-04-14,ACTUAL,2024-06-20,2024-07-16,ACTUAL,,,,2024-06-20,2024-07-16,ACTUAL,2021-05-10,ACTUAL,2021-05-10,2024-06,2024-06-30,2023-06-24,ACTUAL,2023-06-24,2023-06-24,ACTUAL,2023-06-24,,INTERVENTIONAL,SURMOUNT-J,"All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug.",A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease,"Efficacy and Safety of Once-Weekly Tirzepatide in Participants With Obesity Disease: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-J)",COMPLETED,,PHASE3,267.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,f,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,INDUSTRY,,,,,,,2023,1.0
NCT03496766,,2018-03-13,2023-10-05,,2024-03-28,2018-04-05,2018-04-12,ACTUAL,2024-03-28,2024-03-29,ACTUAL,,,,2024-03-28,2024-03-29,ACTUAL,2018-05-07,ACTUAL,2018-05-07,2024-03,2024-03-31,2022-11-09,ACTUAL,2022-11-09,2022-10-30,ACTUAL,2022-10-30,,INTERVENTIONAL,,,Tipifarnib in Advanced Squamous NSCLC With Oncogen HRAS MutAtionS,An Open Label Phase II Study of Tipifarnib in Advanced Squamous Non-small Cell Lung Cancer With HRAS Mutations,TERMINATED,,PHASE2,9.0,ACTUAL,Spanish Lung Cancer Group,"The recruitment was closed prematurely to due to slow recruitment, so there are no consistent data to achieve any relevant conclusion at this point.",1.0,,The recruitment was closed prematurely to due to slow recruitment.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,OTHER,,,,,,,2022,0.0
NCT04912141,,2021-05-21,,,2024-04-01,2021-05-27,2021-06-03,ACTUAL,,,,,,,2024-04-01,2024-04-03,ACTUAL,2021-04-21,ACTUAL,2021-04-21,2023-12,2023-12-31,2023-04-28,ACTUAL,2023-04-28,2023-04-28,ACTUAL,2023-04-28,,INTERVENTIONAL,AKI,,Prevention of Acute Kidney Injury in Patients With NSTEMI,"Conestat Alfa (a Recombinant Human C1 Esterase Inhibitor) for the Prevention of Acute Kidney Injury After Non-ST Elevation Myocardial Infarction: a Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2, Dose-finding Study",TERMINATED,,PHASE2,29.0,ACTUAL,Pharming Technologies B.V.,,4.0,,Lower than expected study enrolment rate. New strategic considerations.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 15:24:52.208295,2024-10-15 15:24:52.208295,INDUSTRY,,,,,,,2023,0.0
NCT02418273,,2015-04-06,,,2019-12-04,2015-04-13,2015-04-16,ESTIMATED,,,,,,,2019-12-04,2019-12-06,ACTUAL,2019-08-01,ESTIMATED,2019-08-01,2019-12,2019-12-31,2021-06,ESTIMATED,2021-06-30,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders,Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders: a Pilot Study,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Indiana University,,2.0,,was not funded,f,,,,t,t,f,,,,,,,,,,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,OTHER,,,,,,,2021,0.0
NCT05097014,,2021-10-12,,,2023-03-23,2021-10-25,2021-10-27,ACTUAL,,,,,,,2023-03-23,2023-03-24,ACTUAL,2021-10-28,ACTUAL,2021-10-28,2023-03,2023-03-31,2023-02-24,ACTUAL,2023-02-24,2023-02-24,ACTUAL,2023-02-24,,INTERVENTIONAL,TRIFORCE,,CHF5993 and CHF1535 pMDI on Lung Hyperinflation and Exercise Endurance Time in Subjects With COPD,"A Double Blind, Multicentre, Randomised, Placebo-Controlled, 3-Way Cross-Over Study To Evaluate The Effect Of A Triple Combination Of Beclometasone Dipropionate And Formoterol Fumarate Plus Glycopyrronium (CHF5993) And A Dual Combination Of Beclometasone Dipropionate Plus Formoterol Fumarate (CHF1535) Both Administered Via pMDI On Lung Hyperinflation And Exercise Endurance Time In Subjects With Chronic Obstructive Pulmonary Disease (COPD)",COMPLETED,,PHASE4,106.0,ACTUAL,Chiesi Farmaceutici S.p.A.,,3.0,,,f,,,,f,f,f,,,,,,,Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.,https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/,YES,"Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.~Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.",2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,INDUSTRY,,,,,,,2023,1.0
NCT04379076,,2020-05-05,,,2022-03-30,2020-05-05,2020-05-07,ACTUAL,,,,,,,2022-03-30,2022-04-07,ACTUAL,2020-05-14,ACTUAL,2020-05-14,2022-03,2022-03-31,2022-03-30,ACTUAL,2022-03-30,2022-02-28,ACTUAL,2022-02-28,,INTERVENTIONAL,ILIAD-7-UK,,InterLeukin-7 (CYT107) to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection UK Cohort,"A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection in UK",TERMINATED,,PHASE2,35.0,ACTUAL,Revimmune,,2.0,,POOR ACCRUAL,f,,,,t,f,f,,,f,,,,,,NO,publication,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,INDUSTRY,,,,,,,2022,0.0
NCT04964414,,2021-07-15,2024-01-10,,2024-06-03,2021-07-15,2021-07-16,ACTUAL,2024-01-10,2024-02-08,ACTUAL,,,,2024-06-03,2024-06-13,ACTUAL,2021-09-30,ACTUAL,2021-09-30,2024-06,2024-06-30,2023-03-29,ACTUAL,2023-03-29,2023-01-13,ACTUAL,2023-01-13,,INTERVENTIONAL,,,Treatment of Pediatric Patients That Lost Sense of Smell Due to COVID-19,Prospective Randomized Study of the Treatment of Pediatric Patients That Lost Sense of Smell Due to COVID-19,TERMINATED,,PHASE1/PHASE2,20.0,ACTUAL,University of Pittsburgh,Early termination and significant loss to follow-up leading to small numbers of subjects analyzed.,2.0,,Slow recruitment,f,,,,f,t,f,,,f,,,Beginning 1 year after publication of summary data. Ending 5 years after publication.,"Proposals should be directed to shafferad@upmc.edu. To gain access, data requestors will need to sign data access agreement.",,YES,"Individual participant data (IPD) may be shared, after de-identification, with researchers who provide a methodologically sound proposal. IPD to be shared will include that necessary to achieve the aims in the approved proposal.",2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,OTHER,,,,,,,2023,0.0
NCT02118337,,2014-04-11,2021-03-17,,2021-05-06,2014-04-16,2014-04-21,ESTIMATED,2021-05-06,2021-06-01,ACTUAL,,,,2021-05-06,2021-06-01,ACTUAL,2014-05-19,ACTUAL,2014-05-19,2021-05,2021-05-31,2020-03-17,ACTUAL,2020-03-17,2020-03-17,ACTUAL,2020-03-17,,INTERVENTIONAL,,"As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.","A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Participants With Select Advanced Malignancies","A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Subjects With Select Advanced Malignancies",COMPLETED,,PHASE1/PHASE2,97.0,ACTUAL,MedImmune LLC,,9.0,,,f,,,,f,,,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,INDUSTRY,,,,,,,2020,1.0
NCT03153137,,2017-05-12,2022-06-30,,2022-08-18,2017-05-12,2017-05-15,ACTUAL,2022-08-18,2022-09-13,ACTUAL,,,,2022-08-18,2022-09-13,ACTUAL,2017-08-14,ACTUAL,2017-08-14,2022-08,2022-08-31,2021-07-26,ACTUAL,2021-07-26,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,RUBATO,,Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects,"Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Adult and Adolescent Subjects",COMPLETED,,PHASE3,142.0,ACTUAL,Actelion,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,INDUSTRY,,,,,,,2021,1.0
NCT03098420,,2017-03-13,2021-05-23,,2021-05-23,2017-03-30,2017-03-31,ACTUAL,2021-05-23,2021-06-18,ACTUAL,,,,2021-05-23,2021-06-18,ACTUAL,2016-07,ACTUAL,2016-07-31,2021-05,2021-05-31,2021-05-20,ACTUAL,2021-05-20,2021-05-20,ACTUAL,2021-05-20,,INTERVENTIONAL,,,Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section,Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section: A Prospective Randomized Double-Blinded Clinical Study,TERMINATED,,PHASE2/PHASE3,29.0,ACTUAL,University of Alabama at Birmingham,"Early termination leading to small numbers of subjects analyzed, due to recruitment challenges related to competing studies in the women and infants center",3.0,,Low enrollment; recruitment challenges due to competing studies in women and infant center,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,OTHER,,,,,,,2021,0.0
NCT03172026,,2017-05-25,2021-07-12,,2021-07-12,2017-05-27,2017-05-31,ACTUAL,2021-07-12,2021-08-03,ACTUAL,,,,2021-07-12,2021-08-03,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2021-07,2021-07-31,2020-10-01,ACTUAL,2020-10-01,2020-10-01,ACTUAL,2020-10-01,,INTERVENTIONAL,MAROS,Only 2 participants were enrolled and began study activities before the study was halted prematurely due to recruitment difficulty.,Maraviroc to Augment Rehabilitation Outcomes After Stroke,Maraviroc to Augment Rehabilitation Outcomes After Stroke,TERMINATED,,PHASE2/PHASE3,2.0,ACTUAL,"University of California, Los Angeles",,2.0,,"Poor recruitment for each site, partly related to Covid epidemic.",f,,,,t,t,f,,,f,,,,,,,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,OTHER,,,,,,,2020,0.0
NCT04094662,,2019-09-17,,,2022-10-20,2019-09-17,2019-09-19,ACTUAL,,,,,,,2022-10-20,2022-10-24,ACTUAL,2019-09-18,ACTUAL,2019-09-18,2022-10,2022-10-31,2022-01-24,ACTUAL,2022-01-24,2022-01-17,ACTUAL,2022-01-17,,INTERVENTIONAL,,,"A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain","A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain",COMPLETED,,PHASE3,393.0,ACTUAL,Daiichi Sankyo,,2.0,,,f,,,,f,f,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,INDUSTRY,,,,,,,2022,1.0
NCT05222516,,2021-12-22,,,2023-08-04,2022-01-24,2022-02-03,ACTUAL,,,,,,,2023-08-04,2023-08-08,ACTUAL,2021-12-20,ACTUAL,2021-12-20,2023-04,2023-04-30,2023-07-13,ACTUAL,2023-07-13,2023-07-13,ACTUAL,2023-07-13,,INTERVENTIONAL,,,Immunomodulation by OM-85 (Broncho-Vaxom) in Early AD,"A Randomised, Double-Blind, Placebo-controlled, 32-week, Phase IIa Trial to Investigate the Efficacy of OM-85 Versus Matched Placebo in Reducing Disease Severity Children Aged 3 to 24 Months With Early Clinical Diagnosis of Moderate Atopic Dermatitis",TERMINATED,,PHASE2,63.0,ACTUAL,OM Pharma SA,,2.0,,Recommendation of DSMB (futility of Endpoints),f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,INDUSTRY,,,,,,,2023,0.0
NCT03532087,,2018-02-05,,,2020-01-16,2018-05-09,2018-05-22,ACTUAL,,,,,,,2020-01-16,2020-01-18,ACTUAL,2018-02,ESTIMATED,2018-02-28,2019-07,2019-07-31,2023-06,ESTIMATED,2023-06-30,2021-02,ESTIMATED,2021-02-28,,INTERVENTIONAL,PERIDENO,,Study to Identify the Impact of Denosumab on the Immune System in Patients With HER2 Negative Breast Cancer,Explorative Trial to Identify the Impact of Denosumab on the Systemic Immunity and Local Immunologic Microenvironment in Postmenopausal Patients With HER2 Negative Breast Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,Borstkanker Onderzoek Groep,,3.0,,Due to new insights,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,NETWORK,,,,,,,2023,0.0
NCT04419558,,2020-06-03,2024-06-26,,2024-08-08,2020-06-03,2020-06-05,ACTUAL,2024-08-08,2024-08-12,ACTUAL,,,,2024-08-08,2024-08-12,ACTUAL,2020-09-30,ACTUAL,2020-09-30,2024-08,2024-08-31,2023-09-04,ACTUAL,2023-09-04,2023-09-04,ACTUAL,2023-09-04,,INTERVENTIONAL,,The intent-to-treat (ITT) population included all randomized participants.,Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF),"Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)",TERMINATED,,PHASE3,372.0,ACTUAL,FibroGen,,2.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,INDUSTRY,,,,,,,2023,0.0
NCT04920331,,2021-06-03,,,2022-02-04,2021-06-03,2021-06-09,ACTUAL,,,,,,,2022-02-04,2022-02-22,ACTUAL,2021-09-07,ACTUAL,2021-09-07,2022-02,2022-02-28,2022-02-04,ACTUAL,2022-02-04,2022-02-04,ACTUAL,2022-02-04,,INTERVENTIONAL,,,Study of Intravenous Erenumab in Patients With Status Migrainosus,STATUS STUDY: Pilot Open-Label Trial of Intravenous Erenumab in Patients With Status Migrainosus,WITHDRAWN,,PHASE1,0.0,ACTUAL,Mayo Clinic,,1.0,,No Participants Enrolled,f,,,,f,t,f,,,,,,,,,,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,OTHER,,,,,,,2022,0.0
NCT04212221,,2019-12-19,2024-06-02,,2024-06-26,2019-12-23,2019-12-26,ACTUAL,2024-06-26,2024-07-23,ACTUAL,,,,2024-06-26,2024-07-23,ACTUAL,2020-04-20,ACTUAL,2020-04-20,2024-06,2024-06-30,2022-04-27,ACTUAL,2022-04-27,2022-04-27,ACTUAL,2022-04-27,,INTERVENTIONAL,,All patients who received at least one dose of study treatment (any component of combination treatment whichever is first).,MGD013 Monotherapy and Combination With Brivanib Dose Escalation and Expansion Study in Advanced Liver Cancer Patients,"A Multicenter, Open-label, Phase I/II Dose Escalation and Expansion Clinical Study to Assess the Safety and Efficacy of MGD013 Monotherapy and in Combination With Brivanib Alaninate (ZL-2301) in Patients With Advanced Liver Cancer",TERMINATED,,PHASE1/PHASE2,89.0,ACTUAL,"Zai Lab (Hong Kong), Ltd.",,2.0,,Due to the rapid shifting of liver cancer disease landscape and the company's adjustment of development strategy.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,INDUSTRY,,,,,,,2022,0.0
NCT04299048,,2020-02-19,2023-03-09,,2023-03-09,2020-03-04,2020-03-06,ACTUAL,2023-03-09,2023-12-14,ACTUAL,,,,2023-03-09,2023-12-14,ACTUAL,2020-11-17,ACTUAL,2020-11-17,2023-03,2023-03-31,2022-03-30,ACTUAL,2022-03-30,2022-03-30,ACTUAL,2022-03-30,,INTERVENTIONAL,,The baseline analysis was performed on treated participants.,Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.,"A PHASE 1B, 12-WEEK, OPEN-LABEL STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS FOLLOWING REPEATED SUBCUTANEOUS ADMINISTRATIONS OF PF-06946860 IN PATIENTS WITH CANCER AND CACHEXIA",COMPLETED,,PHASE1,11.0,ACTUAL,Pfizer,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 22:59:31.617874,2024-10-16 22:59:31.617874,INDUSTRY,,,,,,,2022,1.0
NCT03922945,,2019-04-16,2022-07-19,2022-02-28,2022-08-17,2019-04-18,2019-04-22,ACTUAL,2022-08-17,2022-09-10,ACTUAL,2022-08-17,2022-09-10,ACTUAL,2022-08-17,2022-09-10,ACTUAL,2019-05-02,ACTUAL,2019-05-02,2022-08,2022-08-31,2021-04-16,ACTUAL,2021-04-16,2021-04-16,ACTUAL,2021-04-16,,INTERVENTIONAL,,,A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity,"A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Determine the Safety and Efficacy of VI-0521 in Obese Adolescents",COMPLETED,,PHASE4,223.0,ACTUAL,VIVUS LLC,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,INDUSTRY,,,,,,,2021,1.0
NCT05172141,,2021-12-24,,,2023-02-27,2021-12-24,2021-12-29,ACTUAL,,,,,,,2023-02-27,2023-03-01,ACTUAL,2021-12-31,ACTUAL,2021-12-31,2023-02,2023-02-28,2023-01-31,ACTUAL,2023-01-31,2022-08-31,ACTUAL,2022-08-31,,INTERVENTIONAL,,,"A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19","A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19",TERMINATED,,PHASE1/PHASE2,222.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,2.0,,"Due to the company's development strategy adjustment, Innovant Biologics decided not to continue this study after consultation with investigators.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 01:32:01.57353,2024-10-16 01:32:01.57353,INDUSTRY,,,,,,,2023,0.0
NCT02978404,,2016-11-21,,,2024-06-27,2016-11-28,2016-12-01,ESTIMATED,,,,,,,2024-06-27,2024-06-28,ACTUAL,2017-06-02,ACTUAL,2017-06-02,2024-06,2024-06-30,2023-12-31,ACTUAL,2023-12-31,2021-01-31,ACTUAL,2021-01-31,,INTERVENTIONAL,,,Combining Radiosurgery and Nivolumab in the Treatment of Brain Metastases,"A Phase II, Multi-centre Study, of Combining Radiosurgery and Nivolumab in the Treatment of Brain Metastases From Non-small Cell Lung Cancer and Renal Cell Cancer",COMPLETED,,PHASE2,26.0,ACTUAL,Centre hospitalier de l'Université de Montréal (CHUM),,1.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,OTHER,,,,,,,2023,1.0
NCT02936206,,2016-10-14,2021-04-27,,2021-04-27,2016-10-14,2016-10-18,ESTIMATED,2021-04-27,2021-05-19,ACTUAL,,,,2021-04-27,2021-05-19,ACTUAL,2016-10,,2016-10-31,2021-04,2021-04-30,2020-05-01,ACTUAL,2020-05-01,2020-05-01,ACTUAL,2020-05-01,,INTERVENTIONAL,,"There were 2 participants in the study, both randomized to Tamoxifen arm.",Examination of Breast Cancer Cells of Pre-menopausal and Post-menopausal Women Before and After Exposure to Tamoxifen or Fulvestrant.,"Comparison in the Change of Proliferation Index Between Fulvestrant and Tamoxifen in Cyclin D1 +, Estrogen Receptor + Breast Cancer",TERMINATED,,PHASE1,2.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,2.0,,low accrual rate,f,,,,t,,,,,,,,,,,NO,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,OTHER,,,,,,,2020,0.0
NCT03525613,,2018-04-20,2023-05-15,2022-06-20,2023-06-29,2018-05-03,2018-05-15,ACTUAL,2023-06-29,2023-07-06,ACTUAL,,2023-07-06,ACTUAL,2023-06-29,2023-07-06,ACTUAL,2018-08-31,ACTUAL,2018-08-31,2023-06,2023-06-30,2022-06-28,ACTUAL,2022-06-28,2021-06-28,ACTUAL,2021-06-28,,INTERVENTIONAL,,The intent-to-treat (ITT) analysis set included all subjects assigned to treatment.,A Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration,"A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)",COMPLETED,,PHASE3,637.0,ACTUAL,"Apellis Pharmaceuticals, Inc.",,4.0,,,,,,,t,t,f,,,,,,,,,,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,INDUSTRY,,,,,,,2022,1.0
NCT04088591,,2019-09-11,,,2022-10-14,2019-09-11,2019-09-13,ACTUAL,,,,,,,2022-10-14,2022-10-18,ACTUAL,2022-10,ESTIMATED,2022-10-31,2022-10,2022-10-31,2023-12,ESTIMATED,2023-12-31,2023-11,ESTIMATED,2023-11-30,,INTERVENTIONAL,,,High-dose Intravenous Vitamin C as an Adjunctive Treatment for Sepsis in Rwanda,High-dose Intravenous Vitamin C as an Adjunctive Treatment for Sepsis in Rwanda: a Feasibility Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,Virginia Commonwealth University,,2.0,,Recent studies suggest an increase in mortality due to high-does Vitamin C,f,,,,f,t,f,,,t,,,Beginning 6 months and ending 5 years after study publication.,This data will be made available to researchers who present to the authors a methodologically sound proposal for meta-analysis.,,YES,"All of the individual participant data will be shared, after de-identification, to researchers who present to the authors a methodologically sound proposal for meta-analysis. Proposals should be directed to dahopk@gmail.com.",2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,OTHER,,,,,,,2023,0.0
NCT04521621,,2020-08-17,2024-07-12,,2024-09-04,2020-08-17,2020-08-20,ACTUAL,2024-07-12,2024-08-07,ACTUAL,,,,2024-09-04,2024-10-01,ACTUAL,2020-10-28,ACTUAL,2020-10-28,2024-09,2024-09-30,2023-07-25,ACTUAL,2023-07-25,2023-07-25,ACTUAL,2023-07-25,,INTERVENTIONAL,,No participants were enrolled in Part 2 Cohort D or Part 2 Cohort E arms due to early study termination.,A Study of Gebasaxturev (V937) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (V937-013),A Phase 1b/2 Clinical Study of Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors,TERMINATED,,PHASE1/PHASE2,76.0,ACTUAL,Merck Sharp & Dohme LLC,,8.0,,Business Reasons,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 22:59:31.617874,2024-10-16 22:59:31.617874,INDUSTRY,,,,,,,2023,0.0
NCT02628574,,2015-12-01,,,2020-10-23,2015-12-09,2015-12-11,ESTIMATED,,,,,,,2020-10-23,2020-10-26,ACTUAL,2016-01,ACTUAL,2016-01-31,2020-10,2020-10-31,2020-07-14,ACTUAL,2020-07-14,2020-07-14,ACTUAL,2020-07-14,,INTERVENTIONAL,,,"Phase 1 Open-label Study of TRX518 Monotherapy and TRX518 in Combination With Gemcitabine, Pembrolizumab, or Nivolumab","A Phase 1 Study of TRX518 Monotherapy and TRX518 in Combination With Gemcitabine, Pembrolizumab, or Nivolumab in Adults With Advanced Solid Tumors",COMPLETED,,PHASE1,109.0,ACTUAL,"Leap Therapeutics, Inc.",,4.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,INDUSTRY,,,,,,,2020,1.0
NCT04958226,,2021-07-01,,,2024-01-24,2021-07-01,2021-07-12,ACTUAL,,,,,,,2024-01-24,2024-01-25,ACTUAL,2021-10-15,ACTUAL,2021-10-15,2024-01,2024-01-31,2023-02-15,ACTUAL,2023-02-15,2023-02-06,ACTUAL,2023-02-06,,INTERVENTIONAL,,,A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours,"An Open-label, Fixed-sequence Study to Assess the Effect of Repeated Doses of Capivasertib on the Pharmacokinetics of Oral Midazolam (a CYP450 3A Probe) in Patients With Advanced Solid Tumours",COMPLETED,,PHASE1,21.0,ACTUAL,AstraZeneca,,1.0,,,,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,INDUSTRY,,,,,,,2023,1.0
NCT05620160,,2022-11-04,,,2023-05-22,2022-11-11,2022-11-17,ACTUAL,,,,,,,2023-05-22,2023-05-24,ACTUAL,2022-11-12,ACTUAL,2022-11-12,2023-05,2023-05-31,2023-03-28,ACTUAL,2023-03-28,2023-01-19,ACTUAL,2023-01-19,,INTERVENTIONAL,,,Study of RAY1216 Tablets Compared With Placebo in Patients With Mild to Moderate COVID-19,"A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study of RAY1216 Tablets in Patients With Mild to Moderate SARS-CoV-2 Infection",COMPLETED,,PHASE3,1359.0,ACTUAL,"Guangdong Raynovent Biotech Co., Ltd",,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,INDUSTRY,,,,,,,2023,1.0
NCT05262842,,2022-02-22,,,2022-09-18,2022-02-22,2022-03-02,ACTUAL,,,,,,,2022-09-18,2022-09-21,ACTUAL,2022-03-29,ESTIMATED,2022-03-29,2022-09,2022-09-30,2024-06-06,ESTIMATED,2024-06-06,2024-04-06,ESTIMATED,2024-04-06,,INTERVENTIONAL,,,JS001+IMP4297 in Patients With Advanced Cancer,"A Phase Ⅰ/Ⅰb Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of Toripalimab (Anti-PD-1 Antibody) in Combination With Senaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Shanghai Junshi Bioscience Co., Ltd.",,1.0,,The sponsor voluntarily terminated the study before it was initiated,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,OTHER,,,,,,,2024,0.0
NCT02899026,,2016-09-08,,,2017-11-16,2016-09-08,2016-09-13,ESTIMATED,,,,,,,2017-11-16,2017-11-20,ACTUAL,2018-03-15,ESTIMATED,2018-03-15,2017-11,2017-11-30,2021-08-26,ESTIMATED,2021-08-26,2020-08-26,ESTIMATED,2020-08-26,,INTERVENTIONAL,,,Efficacy and Safety Study of Sirukumab in Subjects With Polymyalgia Rheumatica,"A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in Subjects With Polymyalgia Rheumatica",WITHDRAWN,,PHASE3,0.0,ACTUAL,GlaxoSmithKline,,3.0,,GSK decision to return rights to sirukumab to Janssen and discontinue sirukumab development in polymyalgia rheumatica.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,INDUSTRY,,,,,,,2021,0.0
NCT04508023,,2020-08-10,2023-06-01,,2023-07-17,2020-08-10,2020-08-11,ACTUAL,2023-07-17,2023-07-18,ACTUAL,,,,2023-07-17,2023-07-18,ACTUAL,2020-08-13,ACTUAL,2020-08-13,2023-07,2023-07-31,2022-06-01,ACTUAL,2022-06-01,2022-06-01,ACTUAL,2022-06-01,,INTERVENTIONAL,PREVENT-HD,,"A Study of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic Coronavirus Disease 2019 (COVID-19) Infection","A Multicenter, Randomized, Placebo-Controlled, Pragmatic Phase 3 Study Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic COVID-19 Infection",TERMINATED,,PHASE3,1284.0,ACTUAL,"Janssen Research & Development, LLC",The study was terminated prematurely due to enrollment challenges.,2.0,,The study was terminated prematurely due to enrollment challenges.,f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,INDUSTRY,,,,,,,2022,0.0
NCT03417999,,2018-01-08,2022-09-28,,2023-09-19,2018-01-30,2018-01-31,ACTUAL,2023-09-19,2024-03-22,ACTUAL,,,,2023-09-19,2024-03-22,ACTUAL,2018-06-14,ACTUAL,2018-06-14,2023-09,2023-09-30,2021-10-12,ACTUAL,2021-10-12,2021-10-12,ACTUAL,2021-10-12,,INTERVENTIONAL,,,Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease,Dose Escalation Pharmacokinetic Study of Intranasal Atomized Dexmedetomidine in Pediatric Patients With Congenital Heart Disease,TERMINATED,,PHASE1,28.0,ACTUAL,Children's Hospital of Philadelphia,1. Unable to enroll subjects in Cohort 1B to determine if DEX PK is different in patients spontaneously ventilating with a natural airway versus mechanically ventilated via oral endotracheal tube.~2. Unable to sample long enough to determine elimination phase of IN DEX.~3. Small sample size and heterogenous population limit interpretation of results.~4. COVID delayed enrollment and loss of research personnel.~5. PI left institution prior to completion of study and so study was terminated.,2.0,,"All subjects who were enrolled completed the study. However, the PI left the institution and the study was terminated before all cohorts were enrolled.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,OTHER,,,,,,,2021,0.0
NCT05266586,,2022-02-23,2024-06-07,,2024-06-07,2022-03-03,2022-03-04,ACTUAL,2024-06-07,2024-07-03,ACTUAL,,,,2024-06-07,2024-07-03,ACTUAL,2022-03-09,ACTUAL,2022-03-09,2022-10,2022-10-31,2022-09-08,ACTUAL,2022-09-08,2022-08-12,ACTUAL,2022-08-12,,INTERVENTIONAL,ROSE2,Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.,Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy,"A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Study to Evaluate the Effect of Obicetrapib 10 mg Daily in Combination With Ezetimibe 10 mg Daily as an Adjunct to High-Intensity Statin Therapy: The ROSE 2 Study",COMPLETED,,PHASE2,119.0,ACTUAL,NewAmsterdam Pharma,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,INDUSTRY,,,,,,,2022,1.0
NCT03417102,,2018-01-25,2021-11-22,,2022-03-15,2018-01-30,2018-01-31,ACTUAL,2021-11-22,2021-12-21,ACTUAL,,,,2022-03-15,2022-03-28,ACTUAL,2018-02-14,ACTUAL,2018-02-14,2022-03,2022-03-31,2021-06-23,ACTUAL,2021-06-23,2020-11-25,ACTUAL,2020-11-25,,INTERVENTIONAL,ATLAS-INH,Analysis was performed on Intent-to-Treat (ITT) population which included all randomized participants who were analyzed according to the randomized treatment arm.,A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors,"ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, With Inhibitory Antibodies to Factor VIII or IX",COMPLETED,,PHASE3,60.0,ACTUAL,Sanofi,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,INDUSTRY,,,,,,,2021,1.0
NCT04455958,,2020-07-01,,,2021-04-22,2020-07-01,2020-07-02,ACTUAL,,,,,,,2021-04-22,2021-04-26,ACTUAL,2021-05-01,ESTIMATED,2021-05-01,2021-04,2021-04-30,2021-11-01,ESTIMATED,2021-11-01,2021-11-01,ESTIMATED,2021-11-01,,INTERVENTIONAL,,,Lopinavir/Ritonavir for the Treatment of COVID-19 Positive Patients With Cancer and Immune Suppression in the Last Year,"A Double-Blind, Randomized, Placebo-Controlled Phase II Study of Lopinavir/Ritonavir Versus Placebo in COVID-19 Positive Patients With Cancer and Immune Suppression in the Last Year",WITHDRAWN,,PHASE2,0.0,ACTUAL,OHSU Knight Cancer Institute,,2.0,,limited resources,f,,,,t,t,f,,,,,,,,,,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,OTHER,,,,,,,2021,0.0
NCT04249076,,2020-01-23,2022-11-03,,2022-11-30,2020-01-28,2020-01-30,ACTUAL,2022-11-30,2022-12-22,ACTUAL,,,,2022-11-30,2022-12-22,ACTUAL,2020-06-04,ACTUAL,2020-06-04,2022-11,2022-11-30,2021-04-14,ACTUAL,2021-04-14,2021-04-14,ACTUAL,2021-04-14,,INTERVENTIONAL,CLOSE-2,Safety population,Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-2),"A Phase 3, Multicenter, Randomized, Double-Masked Clinical Trial to Assess the Efficacy and Safety of Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% Compared to Placebo in the Treatment of Inflammation and Pain Associated With Cataract Surgery",COMPLETED,,PHASE3,215.0,ACTUAL,Salvat,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,INDUSTRY,,,,,,,2021,1.0
NCT03795233,,2018-11-21,2021-11-16,,2021-11-16,2019-01-03,2019-01-07,ACTUAL,2021-11-16,2021-12-15,ACTUAL,,,,2021-11-16,2021-12-15,ACTUAL,2019-08-23,ACTUAL,2019-08-23,2021-11,2021-11-30,2021-01-15,ACTUAL,2021-01-15,2021-01-15,ACTUAL,2021-01-15,,INTERVENTIONAL,,,Fecal Microbiota Transplant for Primary CDI,Fecal Microbiota Transplant (FMT) After Treatment for a First Episode of Clostridium Difficile Infection (CDI),TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,Boston Medical Center,The study was terminated after a covid-related suspension and the unavailability of drug. Data were not collected for 5 of the 6 outcomes measures and no data were collected for the primary outcome measure as no participant was in the study at the timeframe of 11 months.,2.0,,The study was terminated after a covid-related suspension and the unavailability of drug.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,OTHER,,,,,,,2021,0.0
NCT04411316,,2020-05-07,,,2021-09-01,2020-05-27,2020-06-02,ACTUAL,,,,,,,2021-09-01,2021-09-09,ACTUAL,2019-12-19,ACTUAL,2019-12-19,2021-09,2021-09-30,2022-12-19,ESTIMATED,2022-12-19,2022-12-19,ESTIMATED,2022-12-19,,INTERVENTIONAL,,,Catheter-directed Thrombolysis Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis,Pharmacomechanical Catheter-directed Thrombolysis (PCDT) Plus Anticoagulation Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis:,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Toledo,,2.0,,Zero Patients met criteria,f,,,,,t,t,,,t,,,,,,NO,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,OTHER,,,,,,,2022,0.0
NCT03019185,,2017-01-06,2023-09-18,2021-09-22,2024-02-01,2017-01-10,2017-01-12,ESTIMATED,2023-09-18,2023-10-11,ACTUAL,2021-09-22,2021-09-28,ACTUAL,2024-02-01,2024-02-02,ACTUAL,2017-03-02,ACTUAL,2017-03-02,2024-02,2024-02-29,2020-10-30,ACTUAL,2020-10-30,2020-10-06,ACTUAL,2020-10-06,,INTERVENTIONAL,CARDINAL,All enrolled patients,A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL,A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome,COMPLETED,,PHASE2/PHASE3,187.0,ACTUAL,Biogen,,3.0,,,f,,,,t,t,f,,,t,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,INDUSTRY,,,,,,,2020,1.0
NCT04344600,,2020-04-10,2022-06-01,,2022-07-12,2020-04-10,2020-04-14,ACTUAL,2022-07-12,2022-07-14,ACTUAL,,,,2022-07-12,2022-07-14,ACTUAL,2020-06-29,ACTUAL,2020-06-29,2022-07,2022-07-31,2021-09-24,ACTUAL,2021-09-24,2021-09-24,ACTUAL,2021-09-24,,INTERVENTIONAL,PROTECT,,Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 (COVID-19) Infection,Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 Infection,TERMINATED,,PHASE2,6.0,ACTUAL,Johns Hopkins University,,2.0,,Single center study with low enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,OTHER,,,,,,,2021,0.0
NCT01460160,,2011-10-25,2018-05-25,,2021-11-08,2011-10-25,2011-10-26,ESTIMATED,2018-07-27,2018-08-21,ACTUAL,,,,2021-11-08,2021-12-08,ACTUAL,2012-04-13,ACTUAL,2012-04-13,2021-11,2021-11-30,2021-06-01,ACTUAL,2021-06-01,2017-05-28,ACTUAL,2017-05-28,,INTERVENTIONAL,,,Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia,"A Phase 2 Multi-Center, Historically Controlled Study of Dasatinib Added to Standard Chemotherapy in Pediatric Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia",COMPLETED,,PHASE2,106.0,ACTUAL,Bristol-Myers Squibb,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 15:00:10.210556,2024-10-15 15:00:10.210556,INDUSTRY,,,,,,,2021,1.0
NCT04834349,,2021-03-05,,,2023-09-11,2021-04-02,2021-04-08,ACTUAL,,,,,,,2023-09-11,2023-09-13,ACTUAL,2021-03-09,ACTUAL,2021-03-09,2023-09,2023-09-30,2022-11-21,ACTUAL,2022-11-21,2022-11-21,ACTUAL,2022-11-21,,INTERVENTIONAL,,,Re-irradiation With NBTXR3 in Combination With Pembrolizumab for the Treatment of Inoperable Locoregional Recurrent Head and Neck Squamous Cell Cancer,A Phase II Study of Reirradiation With NBTXR3 in Patients With Inoperable Locoregional Recurrent Head and Neck Squamous Cell Carcinoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,No participants were enrolled,,,,,f,t,f,,,f,,,,,,,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,OTHER,,,,,,,2022,0.0
NCT04261335,,2020-02-01,,,2023-09-30,2020-02-06,2020-02-07,ACTUAL,,,,,,,2023-09-30,2023-10-03,ACTUAL,2020-03-04,ACTUAL,2020-03-04,2023-09,2023-09-30,2022-12-12,ACTUAL,2022-12-12,2021-09-29,ACTUAL,2021-09-29,,INTERVENTIONAL,SHIELD,,The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy,The Evaluation of Safety and Tolerability of CL2020 in Neonatal Hypoxic Ischemic Encephalopathy Patients With Therapeutic Hypothermia in the Dose Escalation Clinical Trial,COMPLETED,,PHASE1,9.0,ACTUAL,Nagoya University,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,OTHER,,,,,,,2022,1.0
NCT04096573,,2019-09-18,,,2021-11-07,2019-09-18,2019-09-20,ACTUAL,,,,,,,2021-11-07,2021-11-15,ACTUAL,2020-04,ESTIMATED,2020-04-30,2021-11,2021-11-30,2022-08,ESTIMATED,2022-08-31,2021-11,ESTIMATED,2021-11-30,,INTERVENTIONAL,,,Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis,"A Phase 2, Multi Center, Randomized, Placebo Controlled Parallel Group Study to Evaluate the Clinical Efficacy and Safety of LC51 0255 in Subjects With Moderately to Severely Active Ulcerative Colitis",WITHDRAWN,,PHASE2,0.0,ACTUAL,LG Chem,,4.0,,company decision,,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,INDUSTRY,,,,,,,2022,0.0
NCT04178967,,2019-11-25,2022-07-11,,2023-04-24,2019-11-25,2019-11-26,ACTUAL,2022-08-22,2022-09-16,ACTUAL,,,,2023-04-24,2023-05-24,ACTUAL,2019-10-29,ACTUAL,2019-10-29,2023-04,2023-04-30,2022-04-28,ACTUAL,2022-04-28,2021-07-12,ACTUAL,2021-07-12,,INTERVENTIONAL,ADvocate2,"All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.",Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis,"A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis.",COMPLETED,,PHASE3,445.0,ACTUAL,Eli Lilly and Company,One investigational site with eighteen participants was excluded from analysis due to GCP issues.,4.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,INDUSTRY,,,,,,,2022,1.0
NCT03573921,,2018-06-11,,,2023-10-30,2018-06-27,2018-06-29,ACTUAL,,,,,,,2023-10-30,2023-11-01,ACTUAL,2019-09-01,ACTUAL,2019-09-01,2023-10,2023-10-31,2022-12-19,ACTUAL,2022-12-19,2022-12-19,ACTUAL,2022-12-19,,INTERVENTIONAL,,,Gastrografin for Treating Small Bowel Obstruction in Children,The Therapeutic Role of Gastrografin for Treating Small Bowel Obstruction in Children: A Multi-Centre Canadian Prospective Study,TERMINATED,,PHASE2/PHASE3,2.0,ACTUAL,Lawson Health Research Institute,,2.0,,Poor recruitment to date.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,OTHER,,,,,,,2022,0.0
NCT03798366,,2019-01-03,2021-04-09,,2021-04-09,2019-01-08,2019-01-09,ACTUAL,2021-04-09,2021-05-04,ACTUAL,,,,2021-04-09,2021-05-04,ACTUAL,2019-01-14,ACTUAL,2019-01-14,2021-04,2021-04-30,2020-06-22,ACTUAL,2020-06-22,2020-05-21,ACTUAL,2020-05-21,,INTERVENTIONAL,NOVESA,Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of investigational product.,A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Systemic Sclerosis,"A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered GLPG1690 for 24 Weeks in Subjects With Systemic Sclerosis",COMPLETED,,PHASE2,33.0,ACTUAL,Galapagos NV,This was a proof-of-concept study not sized or powered to confirm any treatment effect.,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,INDUSTRY,,,,,,,2020,1.0
NCT04585789,,2020-10-09,2024-02-08,,2024-02-08,2020-10-09,2020-10-14,ACTUAL,2024-02-08,2024-03-05,ACTUAL,,,,2024-02-08,2024-03-05,ACTUAL,2021-03-11,ACTUAL,2021-03-11,2024-02,2024-02-29,2024-01-09,ACTUAL,2024-01-09,2023-02-08,ACTUAL,2023-02-08,,INTERVENTIONAL,INSIGHT,,A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection,"A Phase 2 Randomized, Open-label, Parallel-group, Multicenter Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Response to Combination Regimens Containing JNJ-73763989 and Nucleos(t)Ide Analog With or Without JNJ-56136379 in Patients With Chronic Hepatitis B Virus Infection",COMPLETED,,PHASE2,24.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 11:04:41.874093,2024-10-16 11:04:41.874093,INDUSTRY,,,,,,,2024,1.0
NCT03618823,,2018-08-01,2021-08-31,2021-06-03,2021-10-13,2018-08-01,2018-08-07,ACTUAL,2021-10-13,2021-11-10,ACTUAL,2021-10-13,2021-11-10,ACTUAL,2021-10-13,2021-11-10,ACTUAL,2018-10-25,ACTUAL,2018-10-25,2021-10,2021-10-31,2020-05-18,ACTUAL,2020-05-18,2020-05-18,ACTUAL,2020-05-18,,INTERVENTIONAL,,,Non-opioids for Analgesia After Adenotonsillectomy in Children,Randomized Clinical Trial of Non-Opioid Pain Medications After Adenotonsillectomy,TERMINATED,,PHASE1/PHASE2,268.0,ACTUAL,University of Pittsburgh,Early termination due to COVID-19 cases and cancelled surgeries.,2.0,,Early termination due to COVID-19 cases and cancelled surgeries.,f,,,,t,t,f,,,f,,,All data will be maintained for at least 7 years or until the child turns 23 per University of Pittsburgh policy.,All data will be shared as-needed for analysis amongst the listed co-investigators in the University of Pittsburgh IRB protocol for this study. It will be stored on the UPMC OneDrive.,,YES,Only co-investigators as listed under the University of Pittsburgh IRB (Institutional Review Board) protocol for this study will have access to all data and analysis. Data will be shared via UPMC-associated OneDrive and will only be shared between these investigators.,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,OTHER,,,,,,,2020,0.0
NCT02831933,,2016-07-01,2023-01-13,,2023-08-29,2016-07-11,2016-07-13,ESTIMATED,2023-08-29,2023-09-21,ACTUAL,,,,2023-08-29,2023-09-21,ACTUAL,2017-02-15,ACTUAL,2017-02-15,2023-08,2023-08-31,2020-11-05,ACTUAL,2020-11-05,2020-11-05,ACTUAL,2020-11-05,,INTERVENTIONAL,ENSIGN,,Trial of Radiation and Gene Therapy Before Nivolumab for Metastatic Non-Small Cell Lung Carcinoma and Uveal Melanoma,ENSIGN: Phase II Window of Opportunity Trial of Stereotactic Body Radiation Therapy and In Situ Gene Therapy Followed by Nivolumab in Metastatic Squamous or Non-Squamous Non-Small Cell Lung Carcinoma and Metastatic Uveal Melanoma,TERMINATED,,PHASE2,11.0,ACTUAL,The Methodist Hospital Research Institute,,1.0,,Lack of funding,f,,,,f,t,f,,,,,,,,,YES,"Data and materials on human subjects will be shared with other eligible investigators through appropriate means in accordance with the NIH policy on Sharing Research Data (NIH Guide, February 26, 2003). Data will be also shared with the funding agency and regulatory agencies as required. Data will be shared with other investigators within the limits of HIPAA and other patient confidentiality requirements. This will generally require removal of all patient identifiers for all source documents and the use of arbitrarily assigned one-way identifiers. In some cases, requestors will be asked to sign a formal data sharing agreement that will provide for a commitment to use data only for research purposes and not to identify individuals, keep the data secure, and destroy or return data after analyses are complete. Prior approval will be obtained from collaborating investigators, research sponsors, and/or other stake-holders before sharing if proprietary information or products are involved.",2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,OTHER,,,,,,,2020,0.0
NCT05614648,,2022-10-27,,,2024-04-24,2022-11-05,2022-11-14,ACTUAL,,,,,,,2024-04-24,2024-04-25,ACTUAL,2023-06-19,ACTUAL,2023-06-19,2024-04,2024-04-30,2024-03-30,ACTUAL,2024-03-30,2024-03-18,ACTUAL,2024-03-18,,INTERVENTIONAL,SERENITY CM,,Sciatica Epidural Radiculopathy Experimental New Interventional TherapY Clonidine Micropellet,"A Phase 3, Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Study of the Efficacy and Safety of STX-015 in the Treatment of Pain Associated With Lumbosacral Radiculopathy",TERMINATED,,PHASE3,17.0,ACTUAL,"Sollis Therapeutics, Inc.",,2.0,,Loss of funding- Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.,f,,,,t,t,t,t,,,,,,,,NO,,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,INDUSTRY,,,,,,,2024,0.0
NCT02777385,,2016-04-28,2024-04-23,,2024-07-31,2016-05-16,2016-05-19,ESTIMATED,2024-07-31,2024-08-01,ACTUAL,,,,2024-07-31,2024-08-01,ACTUAL,2016-05-31,ACTUAL,2016-05-31,2024-07,2024-07-31,2023-05-04,ACTUAL,2023-05-04,2023-04-24,ACTUAL,2023-04-24,,INTERVENTIONAL,,,Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy (IMRT) in Head and Neck Cancer,"Randomized, Phase II Study Evaluating Concurrent or Sequential Fixed-Dose Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy in Intermediate or High Risk, Previously Untreated, Locally Advanced Head and Neck Cancer",COMPLETED,,PHASE2,80.0,ACTUAL,University of Pittsburgh,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,OTHER,,,,,,,2023,1.0
NCT03502954,,2018-03-23,,,2020-06-16,2018-04-18,2018-04-19,ACTUAL,,,,,,,2020-06-16,2020-06-17,ACTUAL,2018-02-26,ACTUAL,2018-02-26,2020-06,2020-06-30,2020-03-20,ACTUAL,2020-03-20,2020-02-01,ACTUAL,2020-02-01,,INTERVENTIONAL,,,"A Study to Investigate the Safety, Tolerability and Pharmacokinetics of ABY-039","A Phase 1, First-in-human, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Pharmacokinetic Study of ABY 039 in Healthy Subjects",TERMINATED,,PHASE1,66.0,ACTUAL,Affibody,,4.0,,Halted prematurely,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,INDUSTRY,,,,,,,2020,0.0
NCT03189836,,2017-06-12,,,2021-10-04,2017-06-14,2017-06-16,ACTUAL,,,,,,,2021-10-04,2021-10-11,ACTUAL,2017-10-04,ACTUAL,2017-10-04,2021-10,2021-10-31,2020-09-21,ACTUAL,2020-09-21,2020-09-21,ACTUAL,2020-09-21,,INTERVENTIONAL,,,Study of ACTR707 in Combination With Rituximab in Subjects With Relapsed or Refractory B Cell Lymphoma,"Phase 1 Study of ACTR707, an Autologous T Cell Product, in Combination With Rituximab, in Subjects With Relapsed or Refractory CD20+ B Cell Lymphoma",TERMINATED,,PHASE1,26.0,ACTUAL,"Cogent Biosciences, Inc.",,1.0,,Business decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,INDUSTRY,,,,,,,2020,0.0
NCT03923010,,2019-04-18,,,2021-08-27,2019-04-18,2019-04-22,ACTUAL,,,,,,,2021-08-27,2021-09-01,ACTUAL,2019-08-06,ACTUAL,2019-08-06,2021-08,2021-08-31,2020-03-27,ACTUAL,2020-03-27,2020-03-25,ACTUAL,2020-03-25,,INTERVENTIONAL,,,A Study of Itraconazole in the Management of Superficial Fungal Infections in India,Itraconazole in the Management of Superficial Fungal Infections in India. A Pilot Study,TERMINATED,,PHASE4,40.0,ACTUAL,"Janssen Research & Development, LLC",,1.0,,Further recruitment not possible due to COVID 19 impact. Hence a decision to close study was taken by the sponsor in Aug 2020,f,,,,f,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,INDUSTRY,,,,,,,2020,0.0
NCT04540848,,2020-08-31,,,2021-10-27,2020-09-04,2020-09-07,ACTUAL,,,,,,,2021-10-27,2021-10-29,ACTUAL,2021-03-01,ESTIMATED,2021-03-01,2021-10,2021-10-31,2021-11-20,ESTIMATED,2021-11-20,2021-11-20,ESTIMATED,2021-11-20,,INTERVENTIONAL,,,Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?,Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?,WITHDRAWN,,PHASE4,0.0,ACTUAL,"The University of Texas Health Science Center, Houston",,3.0,,Lack of ability to communicate with the study population,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,OTHER,,,,,,,2021,0.0
NCT04220125,,2020-01-03,,,2023-02-02,2020-01-06,2020-01-07,ACTUAL,,,,,,,2023-02-02,2023-02-06,ACTUAL,2022-09-01,ACTUAL,2022-09-01,2023-02,2023-02-28,2023-02-02,ACTUAL,2023-02-02,2023-02-02,ACTUAL,2023-02-02,,INTERVENTIONAL,,,Preoperative Ketamine and Perioperative Depression,Preoperative Ketamine as a Strategy to Decrease Perioperative Depression During the Perioperative Period: a Randomized Active Controlled Pilot Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,Northwestern University,,2.0,,No enrollment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,OTHER,,,,,,,2023,0.0
NCT02695641,,2016-02-25,,,2020-07-06,2016-02-29,2016-03-01,ESTIMATED,,,,,,,2020-07-06,2020-07-08,ACTUAL,2019-08-01,ESTIMATED,2019-08-01,2020-07,2020-07-31,2021-11,ESTIMATED,2021-11-30,2020-08,ESTIMATED,2020-08-31,,INTERVENTIONAL,,,Reduction of Plasma Free VEGF-A Using Low-dose Bevacizumab in Hemodialysis Patients,A Phase 0 Study to Evaluate the Pharmacokinetics of Low-dose Bevacizumab and Its Efficacy on Reducing Plasma Free Vascular Endothelial Growth Factor-A (VEGF-A) in Hemodialysis Patients,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Mayo Clinic,,2.0,,Unable to enroll patients for the trial.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,OTHER,,,,,,,2021,0.0
NCT03699462,,2018-10-01,,,2020-10-29,2018-10-05,2018-10-09,ACTUAL,,,,,,,2020-10-29,2020-11-02,ACTUAL,2018-11-13,ACTUAL,2018-11-13,2020-10,2020-10-31,2020-10-17,ACTUAL,2020-10-17,2020-10-17,ACTUAL,2020-10-17,,INTERVENTIONAL,,,The Effect of Balanced Crystalloid Versus 5% Albumin on Endothelial Glycocalyx Degradation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery,The Effect of Balanced Crystalloid Versus 5% Albumin on Endothelial Glycocalyx Degradation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery,COMPLETED,,PHASE4,106.0,ACTUAL,Yonsei University,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 22:59:31.617874,2024-10-16 22:59:31.617874,OTHER,,,,,,,2020,1.0
NCT04681027,,2020-12-03,,,2020-12-22,2020-12-22,2020-12-23,ACTUAL,,,,,,,2020-12-22,2020-12-23,ACTUAL,2013-03-11,ACTUAL,2013-03-11,2020-12,2020-12-31,2021-01,ESTIMATED,2021-01-31,2017-04-04,ACTUAL,2017-04-04,,INTERVENTIONAL,,,"Safety, Tolerability, Effectiveness, and Pharmacokinetic Data in Opioid-experienced Children","A Multicenter Study of the Safety, Tolerability, Effectiveness, and Pharmacokinetics of Oxymorphone HCL Extended-Release Tablets in Pediatric Subjects Requiring an Around-The-Clock Opioid for an Extended Period of Time",SUSPENDED,,PHASE3,15.0,ACTUAL,Endo Pharmaceuticals,,2.0,,Study Suspended 06Feb2020 per FDA Request,f,,,,t,t,f,,,,,,,,,YES,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,INDUSTRY,,,,,,,2021,0.0
NCT03586687,,2018-06-21,2021-11-30,,2022-02-08,2018-07-02,2018-07-13,ACTUAL,2022-02-08,2022-03-02,ACTUAL,,,,2022-02-08,2022-03-02,ACTUAL,2018-07-13,ACTUAL,2018-07-13,2022-02,2022-02-28,2021-09-28,ACTUAL,2021-09-28,2021-09-28,ACTUAL,2021-09-28,,INTERVENTIONAL,,,Osteoarthritis Shoulder Injection Study,Clinical Outcomes Following Randomization of Steroid Concentration in Patients With Glenohumeral Osteoarthritis,TERMINATED,,PHASE4,19.0,ACTUAL,Milton S. Hershey Medical Center,Target enrollment was not reached due to the COVID pandemic. The secondary outcome measure involving SPADI at 12 months were not collected due to COVID pandemic.,3.0,,insufficient rate of accrual,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,OTHER,,,,,,,2021,0.0
NCT03386955,,2017-11-04,,,2022-05-13,2017-12-21,2017-12-29,ACTUAL,,,,,,,2022-05-13,2022-05-16,ACTUAL,2017-08-16,ACTUAL,2017-08-16,2022-05,2022-05-31,2021-12-23,ACTUAL,2021-12-23,2021-12-23,ACTUAL,2021-12-23,,INTERVENTIONAL,,,BPI-7711 Capsule in Patients With EGFR Mutation T790M Positive Non-small Cell Lung Cancer,"An Open-label, Single Arm, Phase I/IIa Study to Evaluate Safety, Dose Escalation Tolerability, Pharmacokinetics and Antineoplastic Activity of the BPI-7711 Capsule in Patients With EGFR Mutation Advanced or Recurrent NSCLC",COMPLETED,,PHASE1/PHASE2,215.0,ACTUAL,"Beta Pharma, Inc.",,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,INDUSTRY,,,,,,,2021,1.0
NCT04721535,,2021-01-20,,,2022-12-04,2021-01-20,2021-01-22,ACTUAL,,,,,,,2022-12-04,2022-12-07,ACTUAL,2021-06-07,ACTUAL,2021-06-07,2022-12,2022-12-31,2021-10-06,ACTUAL,2021-10-06,2021-09-23,ACTUAL,2021-09-23,,INTERVENTIONAL,,,A Study of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2,A Randomized Double-blinded Controlled Clinical Trial of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2,TERMINATED,,PHASE3,9.0,ACTUAL,Daewoong Pharmaceutical Co. LTD.,,2.0,,Termination of study due to sponsor's internal decision,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,INDUSTRY,,,,,,,2021,0.0
NCT03652233,,2018-08-20,,,2019-06-17,2018-08-27,2018-08-29,ACTUAL,,,,,,,2019-06-17,2019-06-20,ACTUAL,2018-11-02,ACTUAL,2018-11-02,2019-06,2019-06-30,2022-11,ESTIMATED,2022-11-30,2021-11,ESTIMATED,2021-11-30,,INTERVENTIONAL,,,Afatinib and Nivolumab as Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck,Afatinib and Nivolumab for Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) Not Previously Treated With Immunotherapy.,WITHDRAWN,,PHASE1,0.0,ACTUAL,Vanderbilt-Ingram Cancer Center,,1.0,,Low accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-16 22:59:31.617874,2024-10-16 22:59:31.617874,OTHER,,,,,,,2022,0.0
NCT06625359,,2024-09-30,,,2024-10-01,2024-10-01,2024-10-03,ACTUAL,,,,,,,2024-10-01,2024-10-03,ACTUAL,2015-06-01,ACTUAL,2015-06-01,2024-10,2024-10-31,2024-09-30,ACTUAL,2024-09-30,2024-09-30,ACTUAL,2024-09-30,,INTERVENTIONAL,,,"High-dose Chemotherapy with Thiotepa, Busulfan, and Cyclophosphamide Followed by Autologous Stem Cell Transplantation in Central Nervous System Lymphoma","Efficacy of High-dose Chemotherapy with Thiotepa, Busulfan, and Cyclophosphamide Before Autologous Stem Cell Transplantation in Patients with Primary/secondary Central Nervous System Lymphoma",TERMINATED,,PHASE2,17.0,ACTUAL,Seoul National University Hospital,,1.0,,slow enrollment,f,,,,f,f,f,,,f,,,,,,UNDECIDED,not determined,2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,OTHER,,,,,,,2024,0.0
NCT03320850,,2017-10-23,2021-07-21,,2021-07-21,2017-10-23,2017-10-25,ACTUAL,2021-07-21,2021-08-13,ACTUAL,,,,2021-07-21,2021-08-13,ACTUAL,2017-10-04,ACTUAL,2017-10-04,2021-07,2021-07-31,2020-07-21,ACTUAL,2020-07-21,2020-07-21,ACTUAL,2020-07-21,,INTERVENTIONAL,APOLLO,Stage 1: Safety Analysis Set included all participants who were randomized and treated; Stage 2: Intent-to-treat (ITT) Analysis Set included all randomized participants.,BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence,"A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-treatment, 2-stage, Dose-finding Study Evaluating the Efficacy and Safety of BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence",COMPLETED,,PHASE2,383.0,ACTUAL,Allergan,,8.0,,,f,,,,t,t,f,,,,,,,,,YES,* Phase II or III trials completed after 2008~* Listed on clinicaltrials.gov or EudraCT~* Have received regulatory approval in the United States and/or European Union (depending on registration plans) in a given indication~* Primary manuscript(s) from the trial have been published~Access to data is contingent upon the following:~* Researcher signs a data use agreement from Allergan~* Data is to be used for non-commercial purposes,2024-10-16 22:59:31.617874,2024-10-16 22:59:31.617874,INDUSTRY,,,,,,,2020,1.0
NCT04220502,,2020-01-03,,,2022-05-03,2020-01-03,2020-01-07,ACTUAL,,,,,,,2022-05-03,2022-05-09,ACTUAL,2020-08-01,ACTUAL,2020-08-01,2022-05,2022-05-31,2022-05-03,ACTUAL,2022-05-03,2022-05-03,ACTUAL,2022-05-03,,INTERVENTIONAL,,,Magic Shave Powder Gold's Affects on the Occurrence of Pseudofolliculitis Barbae,Depilatory Cream's Affect on the Occurrence of Pseudofolliculitis Barbae,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Wayne State University,,2.0,,Unable to recruit,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 11:10:27.881881,2024-10-16 11:10:27.881881,OTHER,,,,,,,2022,0.0
NCT04732429,,2021-01-21,,,2024-01-03,2021-01-26,2021-02-01,ACTUAL,,,,,,,2024-01-03,2024-01-05,ACTUAL,2021-03-15,ACTUAL,2021-03-15,2024-01,2024-01-31,2023-10-20,ACTUAL,2023-10-20,2023-10-20,ACTUAL,2023-10-20,,INTERVENTIONAL,HERO,,Study of HST5040 in Subjects With Propionic or Methylmalonic Acidemia,"A Phase 2 Open-label, Dose Escalation Study of HST5040 in Subjects With Propionic or Methylmalonic Acidemia Followed by a Randomized, Double-blind, Placebo-controlled, 2-period Crossover Study and an Open-label, Long-term Extension Study",TERMINATED,,PHASE2,26.0,ACTUAL,HemoShear Therapeutics,,2.0,,The decision to terminate the study was based on business considerations by the Sponsor.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,INDUSTRY,,,,,,,2023,0.0
NCT01659658,,2012-08-02,2023-07-10,,2024-04-19,2012-08-07,2012-08-08,ESTIMATED,2023-08-25,2023-09-21,ACTUAL,,,,2024-04-19,2024-04-25,ACTUAL,2012-12-26,ACTUAL,2012-12-26,2024-04,2024-04-30,2022-07-11,ACTUAL,2022-07-11,2022-07-11,ACTUAL,2022-07-11,,INTERVENTIONAL,,Intent-to-Treat (ITT) Population included all participants who were randomized.,Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physicians Choice of Treatment in Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis,"A Phase 3, Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physicians Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis",TERMINATED,,PHASE3,177.0,ACTUAL,Takeda,,5.0,,Sponsor's decision,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,INDUSTRY,,,,,,,2022,0.0
NCT04699461,,2021-01-05,2023-08-24,,2023-09-28,2021-01-05,2021-01-07,ACTUAL,2023-09-28,2023-10-23,ACTUAL,,,,2023-09-28,2023-10-23,ACTUAL,2021-11-04,ACTUAL,2021-11-04,2023-09,2023-09-30,2022-11-25,ACTUAL,2022-11-25,2022-11-25,ACTUAL,2022-11-25,,INTERVENTIONAL,LOTIS-6,,Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine Versus Idelalisib in Participants With Relapsed or Refractory Follicular Lymphoma,A Phase 2 Randomized Study of Loncastuximab Tesirine Versus Idelalisib in Patients With Relapsed or Refractory Follicular Lymphoma (LOTIS-6),TERMINATED,,PHASE2,6.0,ACTUAL,ADC Therapeutics S.A.,"The study was terminated (administrative decision) by the sponsor following the withdrawal of idelalisib from the US market for the relapsed FL indication (i.e., not due to any safety reasons emerging from this study).",2.0,,Administrative decision (not due to safety reason),f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,INDUSTRY,,,,,,,2022,0.0
NCT02437084,,2015-04-24,2021-03-11,,2021-03-11,2015-05-04,2015-05-07,ESTIMATED,2021-03-11,2021-04-06,ACTUAL,,,,2021-03-11,2021-04-06,ACTUAL,2015-05,ACTUAL,2015-05-31,2021-03,2021-03-31,2020-04,ACTUAL,2020-04-30,2020-02,ACTUAL,2020-02-29,,INTERVENTIONAL,,Participants who completed both baseline and end-of-study tests and did not receive treatment with a corticosteroid.,"Relationship Between Insulin Resistance and Statin Induced Type 2 Diabetes, and Integrative Personal Omics Profiling","Relationship Between Insulin Resistance and Statin Induced Type 2 Diabetes, and Integrative Personal Omics Profiling",COMPLETED,,PHASE4,115.0,ACTUAL,Stanford University,Our study was a single-center trial with a single dose of atorvastatin without a placebo control group. The study was also short term and longer trials are needed to assess for potential decreases in insulin secretion or further increases in insulin resistance.,1.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,OTHER,,,,,,,2020,1.0
NCT03535740,,2018-05-09,2021-09-24,,2024-09-17,2018-05-22,2018-05-24,ACTUAL,2021-09-24,2021-10-25,ACTUAL,,,,2024-09-17,2024-10-01,ACTUAL,2019-01-31,ACTUAL,2019-01-31,2024-09,2024-09-30,2024-08-21,ACTUAL,2024-08-21,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,ALTA-2,Full Analysis Set (FAS) included all participants who received at least 1 dose of brigatinib.,"A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib","Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib",COMPLETED,,PHASE2,103.0,ACTUAL,Takeda,,1.0,,,f,,,,f,t,f,,,t,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 22:59:31.617874,2024-10-16 22:59:31.617874,INDUSTRY,,,,,,,2024,1.0
NCT04936841,,2021-06-10,2024-02-08,,2024-03-06,2021-06-15,2021-06-23,ACTUAL,2024-03-06,2024-04-04,ACTUAL,,,,2024-03-06,2024-04-04,ACTUAL,2021-08-05,ACTUAL,2021-08-05,2024-03,2024-03-31,2022-10-04,ACTUAL,2022-10-04,2022-10-04,ACTUAL,2022-10-04,,INTERVENTIONAL,,,Bempegaldesleukin (NKTR-214) With Radiation and Anti-PD-1 Immunotherapy for Head and Neck Squamous Cell Carcinoma,Phase II Study of Bempegaldesleukin (NKTR-214) Together With Palliative Radiation and Anti-PD-1 Checkpoint Blockade in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC),TERMINATED,,PHASE2,5.0,ACTUAL,"University of Wisconsin, Madison",Study terminated early by the sponsor,1.0,,study closed by the sponsor,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,OTHER,,,,,,,2022,0.0
NCT04675996,,2020-12-08,,,2024-02-06,2020-12-15,2020-12-19,ACTUAL,,,,,,,2024-02-06,2024-02-08,ACTUAL,2020-12-18,ACTUAL,2020-12-18,2024-02,2024-02-29,2023-03-24,ACTUAL,2023-03-24,2023-03-24,ACTUAL,2023-03-24,,INTERVENTIONAL,,,First-in-Human Study of INT-1B3 in Patients With Advanced Solid Tumors,"Phase I/Ib, Open-label, Multiple Ascending Dose, First-in-Human Study, to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of INT-1B3 in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1,25.0,ACTUAL,InteRNA,,1.0,,insufficient funding,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,INDUSTRY,,,,,,,2023,0.0
NCT02649673,,2016-01-05,,,2023-12-01,2016-01-06,2016-01-07,ESTIMATED,,,,,,,2023-12-01,2023-12-05,ACTUAL,2016-03-23,ACTUAL,2016-03-23,2022-06,2022-06-30,2021-07-30,ACTUAL,2021-07-30,2021-07-30,ACTUAL,2021-07-30,,INTERVENTIONAL,,,LCL161 Plus Topotecan for Patients With Relapsed/Refractory Small Cell Lung Cancer and Select Gynecologic Malignancies,Phase Ib Dose-Escalation Study of LCL161 in Combination With Oral Topotecan for Patients With Relapsed/Refractory Small Cell Lung Cancer (SCLC) and Select Gynecologic Malignancies,TERMINATED,,PHASE1,34.0,ACTUAL,"SCRI Development Innovations, LLC",,1.0,,Clinical program was discontinued by Novartis,f,,,,f,,,,,,,,,,,,,2024-10-16 11:10:27.881881,2024-10-16 11:10:27.881881,OTHER,,,,,,,2021,0.0
NCT04209465,,2019-12-19,,,2022-10-13,2019-12-20,2019-12-24,ACTUAL,,,,,,,2022-10-13,2022-10-14,ACTUAL,2019-12-19,ACTUAL,2019-12-19,2022-10,2022-10-31,2022-09-16,ACTUAL,2022-09-16,2022-09-02,ACTUAL,2022-09-02,,INTERVENTIONAL,MasterKey-01,,"A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.","MasterKey-01: A Phase 1/2, Open-label, Two-part, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics & Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB Mutations, in Patients w/ Advanced Solid Malignancies",TERMINATED,,PHASE1/PHASE2,91.0,ACTUAL,"Black Diamond Therapeutics, Inc.",,2.0,,The development of BDTX-189 was discontinued by the sponsor.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,INDUSTRY,,,,,,,2022,0.0
NCT03556202,,2018-06-04,2023-02-03,,2023-03-17,2018-06-04,2018-06-14,ACTUAL,2023-03-17,2023-03-21,ACTUAL,,,,2023-03-17,2023-03-21,ACTUAL,2018-09-03,ACTUAL,2018-09-03,2023-03,2023-03-31,2022-02-07,ACTUAL,2022-02-07,2022-02-07,ACTUAL,2022-02-07,,INTERVENTIONAL,,All randomized participants.,A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3),"A Multicenter, Long-Term Extension to Evaluate the Long-term Safety and Maintenance of Treatment Effect of LY3074828 in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-3",TERMINATED,,PHASE3,1936.0,ACTUAL,Eli Lilly and Company,"This study was terminated before completion of the long-term extension trial, due to strategic business decision made by the company.",3.0,,The study was terminated due to a strategic business decision made by the Sponsor.,f,,,,t,t,f,,,,,,,,,YES,Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.~This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.,2024-10-16 11:10:27.881881,2024-10-16 11:10:27.881881,INDUSTRY,,,,,,,2022,0.0
NCT02285543,,2014-10-22,,,2023-11-21,2014-11-04,2014-11-07,ESTIMATED,,,,,,,2023-11-21,2023-11-22,ACTUAL,2016-12-01,ACTUAL,2016-12-01,2023-11,2023-11-30,2023-07-30,ACTUAL,2023-07-30,2023-07-30,ACTUAL,2023-07-30,,INTERVENTIONAL,,,A Phase II Trial of TPF Induction Chemotherapy in cN2 OSCC Patients,A Randomized Phase II Trial of TPF Induction Chemotherapy in cN2 Patients With Oral Squamous Cell Carcinoma,TERMINATED,,PHASE2,10.0,ACTUAL,Shanghai Jiao Tong University School of Medicine,,2.0,,No new participants could be enrolled.,f,,,,t,,,,,,,,,,,,,2024-10-16 22:59:31.617874,2024-10-16 22:59:31.617874,OTHER,,,,,,,2023,0.0
NCT03161574,,2017-05-18,,,2019-08-06,2017-05-19,2017-05-22,ACTUAL,,,,,,,2019-08-06,2019-08-08,ACTUAL,2017-08-11,ACTUAL,2017-08-11,2019-08,2019-08-31,2022-06-01,ESTIMATED,2022-06-01,2019-12-01,ESTIMATED,2019-12-01,,INTERVENTIONAL,,,FOLFOXIRI Chemotherapy Alone as Neoadjuvant Treatment for Circumferential Radial Margin (CRM) Positive Rectal Cancer,FOLFOXIRI Chemotherapy Alone as Neoadjuvant Treatment for MRI-defined Circumferential Radial Margin (CRM) Positive Rectal Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,Guangxi Medical University,,1.0,,No participants were recruited,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,OTHER,,,,,,,2022,0.0
NCT03326128,,2017-10-18,,,2023-07-13,2017-10-25,2017-10-31,ACTUAL,,,,,,,2023-07-13,2023-07-17,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2023-07,2023-07-31,2023-07-01,ACTUAL,2023-07-01,2023-07-01,ACTUAL,2023-07-01,,INTERVENTIONAL,,,High Dose Bupropion for Smoking Cessation - Pilot Study,High Dose Bupropion Treatment for Smoking Cessation - Pilot Study,TERMINATED,,PHASE2,12.0,ACTUAL,University of Southern California,,2.0,,"Due to the COVID-19 pandemic, it was difficult to recruit eligible participants.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 22:59:31.617874,2024-10-16 22:59:31.617874,OTHER,,,,,,,2023,0.0
NCT03829969,,2019-01-17,2022-03-31,,2024-04-08,2019-02-01,2019-02-04,ACTUAL,2024-04-08,2024-05-02,ACTUAL,,,,2024-04-08,2024-05-02,ACTUAL,2019-01-31,ACTUAL,2019-01-31,2024-02,2024-02-29,2023-09-30,ACTUAL,2023-09-30,2021-03-22,ACTUAL,2021-03-22,,INTERVENTIONAL,JUPITER06,,Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma,"A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Compare Toripalimab Injection (JS001) Combined With Standard Chemotherapy Versus Placebo Combined With Standard Chemotherapy in Treatment of Advanced or Metastatic Esophageal Squamous Cell Cancer (ESCC) Without Previous Systemic Chemotherapy",COMPLETED,,PHASE3,514.0,ACTUAL,"Shanghai Junshi Bioscience Co., Ltd.",,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 22:59:31.617874,2024-10-16 22:59:31.617874,OTHER,,,,,,,2023,1.0
NCT05108922,,2021-10-26,2023-09-07,,2023-10-11,2021-10-26,2021-11-05,ACTUAL,2023-10-11,2023-11-02,ACTUAL,,,,2023-10-11,2023-11-02,ACTUAL,2021-11-16,ACTUAL,2021-11-16,2023-10,2023-10-31,2023-09-19,ACTUAL,2023-09-19,2022-09-09,ACTUAL,2022-09-09,,INTERVENTIONAL,,All randomized participants who received at least one dose of study drug to donanemab or aducanumab.,A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4),"A Phase 3, Open-Label, Parallel-Group, 2-Arm Study to Investigate Amyloid Plaque Clearance With Donanemab Compared With Aducanumab-avwa in Participants With Early Symptomatic Alzheimer's Disease",COMPLETED,,PHASE3,148.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 22:59:31.617874,2024-10-16 22:59:31.617874,INDUSTRY,,,,,,,2023,1.0
NCT05060965,,2021-09-20,,,2023-08-10,2021-09-20,2021-09-29,ACTUAL,,,,,,,2023-08-10,2023-08-15,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2023-08,2023-08-31,2023-04,ESTIMATED,2023-04-30,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,,,Inpatient Smoking Cessation Pilot Program,Smoking Cessation Pilot Program on 9 South,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Johns Hopkins University,,1.0,,No Enrollees,f,,,,f,t,f,,,,,,,,,NO,De-identified participant data will be shared with researchers or sponsor upon review of a written request. The request will require a detailed description of the usage of the data and will require approval by the principal investigator. A data use agreement will be set-up and a plan for data removal (including timeline) will be established.,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,OTHER,,,,,,,2023,0.0
NCT03225846,,2017-07-17,2021-12-17,,2022-03-28,2017-07-19,2017-07-21,ACTUAL,2022-03-28,2022-04-25,ACTUAL,,,,2022-03-28,2022-04-25,ACTUAL,2017-07-17,ACTUAL,2017-07-17,2022-01,2022-01-31,2021-05-10,ACTUAL,2021-05-10,2021-05-10,ACTUAL,2021-05-10,,INTERVENTIONAL,PRECISION-HD2,,Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease,"A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120102 Administered Intrathecally in Patients With Huntington's Disease",TERMINATED,,PHASE1/PHASE2,88.0,ACTUAL,Wave Life Sciences Ltd.,,5.0,,Lack of efficacy,f,,,,t,t,f,,,,,,,,,,,2024-10-15 15:24:52.208295,2024-10-15 15:24:52.208295,INDUSTRY,,,,,,,2021,0.0
NCT04427501,,2020-06-09,2022-02-14,,2024-04-05,2020-06-11,2020-06-11,ACTUAL,2022-02-14,2022-03-07,ACTUAL,,,,2024-04-05,2024-04-11,ACTUAL,2020-06-17,ACTUAL,2020-06-17,2024-04,2024-04-30,2023-02-21,ACTUAL,2023-02-21,2023-02-21,ACTUAL,2023-02-21,,INTERVENTIONAL,BLAZE-1,All randomized participants who received at least one dose of study drug.,A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness,"A Randomized, Double-blind, Placebo-Controlled, Phase 2/3 Study to Evaluate the Efficacy and Safety of LY3819253 and LY3832479 in Participants With Mild to Moderate COVID-19 Illness",COMPLETED,,PHASE2/PHASE3,3307.0,ACTUAL,Eli Lilly and Company,,5.0,,,f,,,,t,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting","Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting",http://vivli.org/,YES,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,INDUSTRY,,,,,,,2023,1.0
NCT03324282,,2017-10-19,,,2022-04-26,2017-10-24,2017-10-27,ACTUAL,,,,,,,2022-04-26,2022-05-03,ACTUAL,2018-02-23,ACTUAL,2018-02-23,2022-04,2022-04-30,2022-01-14,ACTUAL,2022-01-14,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,GCISAVE,,First-line Gemcitabine/Cisplatin +/- Avelumab in Locally Advanced or Metastatic Bladder Carcinoma,Gemcitabine-cisplatin Plus Avelumab or Gemcitabine-cisplatin as First-line Treatment of Patients With Locally Advanced or Metastatic Urothelial Bladder Carcinoma (GCISAVE),TERMINATED,,PHASE2,65.0,ACTUAL,"University Hospital, Bordeaux",,2.0,,"ANSM's refusal to validate ATU requests for avelumab in bladder cancer, Decrease in recruitment, Most investigators would like to offer avelumab for maintenance, Absence of benefit to the chemo-immuno combination (pembro+gem-platinum) in phase III",f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 11:10:27.881881,2024-10-16 11:10:27.881881,OTHER,,,,,,,2022,0.0
NCT05073237,,2021-09-28,,,2024-05-07,2021-09-28,2021-10-11,ACTUAL,,,,,,,2024-05-07,2024-05-10,ACTUAL,2024-04-08,ACTUAL,2024-04-08,2024-05,2024-05-31,2024-04-08,ACTUAL,2024-04-08,2024-04-08,ACTUAL,2024-04-08,,INTERVENTIONAL,CE/BZA,,Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans,Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans,WITHDRAWN,,PHASE2,0.0,ACTUAL,VA Office of Research and Development,,2.0,,withdrawn,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,FED,,,,,,,2024,0.0
NCT04226365,,2020-01-09,,,2024-05-24,2020-01-09,2020-01-13,ACTUAL,,,,,,,2024-05-24,2024-05-29,ACTUAL,2020-02-15,ACTUAL,2020-02-15,2024-05,2024-05-31,2023-05-31,ACTUAL,2023-05-31,2023-05-31,ACTUAL,2023-05-31,,INTERVENTIONAL,PeCon,,Pediatric Concussion Outcomes,"Treatment for Post-concussive Headache: A Randomized, Placebo-controlled, Double Blinded Trial",TERMINATED,,PHASE4,8.0,ACTUAL,Lancaster General Hospital,,2.0,,The study was stopped prematurely due to a low enrollment rate.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 11:10:27.881881,2024-10-16 11:10:27.881881,OTHER,,,,,,,2023,0.0
NCT04891185,,2021-05-05,,,2023-10-02,2021-05-12,2021-05-18,ACTUAL,,,,,,,2023-10-02,2023-10-05,ACTUAL,2021-10-01,ACTUAL,2021-10-01,2023-05,2023-05-31,2023-10-01,ACTUAL,2023-10-01,2023-10-01,ACTUAL,2023-10-01,,INTERVENTIONAL,VIPIDO,,Visualisation of Indocyanine Green in Primary and Interval Debulking for Ovarian Cancer,Visualisation of Indocyanine Green in Primary and Interval Debulking for Ovarian Cancer,TERMINATED,,PHASE2,14.0,ACTUAL,Universitaire Ziekenhuizen KU Leuven,,2.0,,Clinical futility,f,,,,f,f,f,,,f,,,,,,UNDECIDED,According to FAIR principle will data sharing be possible after conclusion of this trial.,2024-10-15 01:21:06.325261,2024-10-15 01:21:06.325261,OTHER,,,,,,,2023,0.0
NCT03982069,,2019-06-06,2021-08-18,,2021-09-17,2019-06-06,2019-06-11,ACTUAL,2021-09-17,2021-10-14,ACTUAL,,,,2021-09-17,2021-10-14,ACTUAL,2019-09-20,ACTUAL,2019-09-20,2021-09,2021-09-30,2020-12-09,ACTUAL,2020-12-09,2020-12-09,ACTUAL,2020-12-09,,INTERVENTIONAL,,,Immunologic Response to FluMist vs. Flucelvax,"Immunological Response to Influenza Vaccination in Children, Adolescents, and Young Adults: A RCT of FluMist vs. Flucelvax",COMPLETED,,PHASE4,465.0,ACTUAL,University of Pittsburgh,,2.0,,,f,,,,t,t,f,,,f,,,Beginning 9 months and ending 36 months after article publication.,Researchers who provide a methodologically sound proposal and have appropriate data security and privacy plans in place,http://github.com/pittvax,YES,"Individual participant data that underlie the results reported in the primary article, after deidentification, will be placed at the site mentioned below.",2024-10-16 11:10:27.881881,2024-10-16 11:10:27.881881,OTHER,,,,,,,2020,1.0
NCT04920578,,2021-06-08,,,2024-03-13,2021-06-08,2021-06-10,ACTUAL,,,,,,,2024-03-13,2024-03-15,ACTUAL,2021-06-16,ACTUAL,2021-06-16,2024-03,2024-03-31,2023-02-27,ACTUAL,2023-02-27,2023-01-27,ACTUAL,2023-01-27,,INTERVENTIONAL,,,A Study of JNJ-69095897 in Healthy Participants,"A 3-Part, Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-69095897 in Healthy Participants",TERMINATED,,PHASE1,48.0,ACTUAL,"Janssen Research & Development, LLC",,3.0,,business decision to end clinical development of JNJ-69095897,f,,,,f,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,INDUSTRY,,,,,,,2023,0.0
NCT02545361,,2015-08-04,,,2018-08-14,2015-09-06,2015-09-10,ESTIMATED,,,,,,,2018-08-14,2018-08-16,ACTUAL,2018-04,ESTIMATED,2018-04-30,2018-08,2018-08-31,2020-04,ESTIMATED,2020-04-30,2020-04,ESTIMATED,2020-04-30,,INTERVENTIONAL,,,"Safety, Tolerability, and Anti-cancer Activity of KAHR-102 (The Study Drug) for the Treatment of Lymphoma Patients","A Phase 1/2a, Multi-center, Dose Escalation, 2 Stages Study to Evaluate the Safety, Tolerability, and Anti-cancer Activity of Subcutaneously Administered KAHR-102 for the Treatment of Lymphoma Patients Who Express Both B7 and FasR",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Kahr Medical,,1.0,,Program de-prioritized,f,,,,t,f,f,,,,,,,,,,,2024-10-16 22:59:31.617874,2024-10-16 22:59:31.617874,INDUSTRY,,,,,,,2020,0.0
NCT05368402,,2022-05-05,,,2023-12-21,2022-05-05,2022-05-10,ACTUAL,,,,,,,2023-12-21,2023-12-22,ACTUAL,2022-07-27,ACTUAL,2022-07-27,2023-11,2023-11-30,2023-09-18,ACTUAL,2023-09-18,2023-09-18,ACTUAL,2023-09-18,,INTERVENTIONAL,CONSERVA,,Clinical Trial on Ladarixin Adjunctive Therapy to Improve Glycemic Control in Type 1 Diabetes.,"Randomized, Placebo-controlled, Double-blinded, 2-parallel Arm, Clinical Trial Evaluating Ladarixin 400 mg Bid as Adjunctive Therapy to Improve Glycemic Control in Overweight Insulin-resistant Patients With Type 1 Diabetes.",TERMINATED,,PHASE2,2.0,ACTUAL,Dompé Farmaceutici S.p.A,,2.0,,low recruitment rate,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 22:59:31.617874,2024-10-16 22:59:31.617874,INDUSTRY,,,,,,,2023,0.0
NCT03645057,,2018-08-22,2022-07-06,,2022-10-27,2018-08-22,2018-08-24,ACTUAL,2022-10-27,2022-10-31,ACTUAL,,,,2022-10-27,2022-10-31,ACTUAL,2019-02-20,ACTUAL,2019-02-20,2022-10,2022-10-31,2021-08-01,ACTUAL,2021-08-01,2021-08-01,ACTUAL,2021-08-01,,INTERVENTIONAL,,,ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis,ASPIRE: DETERIMINING THE IMPACT OF CRISABOROLE (Eucrisa) AND TACROLIMUS 0.03% ON PATIENT-REPORTED OUTCOMES AND CAREGIVER BURDEN IN CHILDREN WITH ATOPIC DERMATITIS,COMPLETED,,PHASE3,92.0,ACTUAL,University of Rochester,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 01:37:36.674172,2024-10-16 01:37:36.674172,OTHER,,,,,,,2021,1.0
NCT03486587,,2018-03-18,,,2021-09-27,2018-03-31,2018-04-03,ACTUAL,,,,,,,2021-09-27,2021-10-04,ACTUAL,2018-04-15,ACTUAL,2018-04-15,2021-09,2021-09-30,2020-12-31,ACTUAL,2020-12-31,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,,,A Study Evaluating Bacillus Cereus in the Prevention of Afatinib-associated Diarrhea,"A Single-arm, Single-institutional, Phase II Study Evaluating the Efficacy and Safety of Bacillus Cereus (Changfukang®) in the Prevention of Afatinib-associated Diarrhea in NSCLC Patients",TERMINATED,,PHASE2,12.0,ACTUAL,Sun Yat-sen University,,1.0,,"Participants have better treatment selection, resulting in a slow recruitment.",f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,OTHER,,,,,,,2020,0.0
NCT03263780,,2017-08-22,2020-12-17,,2021-02-02,2017-08-22,2017-08-28,ACTUAL,2021-02-02,2021-02-21,ACTUAL,,,,2021-02-02,2021-02-21,ACTUAL,2017-12-07,ACTUAL,2017-12-07,2021-02,2021-02-28,2020-01-08,ACTUAL,2020-01-08,2020-01-08,ACTUAL,2020-01-08,,INTERVENTIONAL,,,High Resolution PET-MRI Before Prostate Cancer HIFU,"High-Resolution, 18F-fluciclovine PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy",COMPLETED,,PHASE2,21.0,ACTUAL,Cedars-Sinai Medical Center,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,OTHER,,,,,,,2020,1.0
NCT02489123,,2015-06-30,2021-06-11,,2021-07-16,2015-06-30,2015-07-02,ESTIMATED,2021-07-16,2021-08-10,ACTUAL,,,,2021-07-16,2021-08-10,ACTUAL,2015-08-11,ACTUAL,2015-08-11,2021-07,2021-07-31,2020-06-16,ACTUAL,2020-06-16,2020-06-16,ACTUAL,2020-06-16,,INTERVENTIONAL,,,Enzalutamide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma,Androgen Receptor Targeting in Mantle Cell Lymphoma: A Pilot Trial of Enzalutamide,TERMINATED,,PHASE2,8.0,ACTUAL,University of Washington,,1.0,,Accrual goal not met,f,,,,f,t,f,,,,,,,,,,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,OTHER,,,,,,,2020,0.0
NCT00319332,,2006-04-26,,,2015-04-15,2006-04-26,2006-04-27,ESTIMATED,,,,,,,2015-04-15,2015-04-17,ESTIMATED,2005-09,,2005-09-30,2015-04,2015-04-30,2021-02,ESTIMATED,2021-02-28,2021-02,ESTIMATED,2021-02-28,,INTERVENTIONAL,,,A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen,"A Multi-center, Randomized, Phase 3 Study of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen for Patients With Relapsed or Transformed Follicular Non-Hodgkin's Lymphoma",WITHDRAWN,,PHASE3,0.0,ACTUAL,GlaxoSmithKline,,,,This study has been cancelled prior to enrollment,f,,,,,,,,,,,,,,,,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,INDUSTRY,,,,,,,2021,0.0
NCT03101085,,2017-03-29,2022-06-21,,2024-07-16,2017-03-29,2017-04-04,ACTUAL,2024-07-11,2024-07-17,ACTUAL,,,,2024-07-16,2024-07-25,ACTUAL,2017-05-05,ACTUAL,2017-05-05,2024-07,2024-07-31,2021-03-01,ACTUAL,2021-03-01,2021-03-01,ACTUAL,2021-03-01,,INTERVENTIONAL,SEAD2,,S-Equol in Alzheimer's Disease 2 Trial,S-Equol in Alzheimer's Disease 2 (SEAD2) Trial,COMPLETED,,PHASE1/PHASE2,40.0,ACTUAL,University of Kansas Medical Center,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,OTHER,,,,,,,2021,1.0
NCT03743103,,2018-11-13,,,2023-02-07,2018-11-13,2018-11-15,ACTUAL,,,,,,,2023-02-07,2023-02-09,ACTUAL,2019-04-18,ACTUAL,2019-04-18,2023-01,2023-01-31,2021-10-31,ACTUAL,2021-10-31,2021-10-31,ACTUAL,2021-10-31,,INTERVENTIONAL,ETHICHS,,Esmolol for the Treatment of Hypertension After Intracerebral Hemorrhage Study (ETHICHS),"A Randomized, Exploratory, Open-label, Phase IV, Blinded Endpoint, Multicenter and Prospective Study to Evaluate the Effect of the Addition of Esmolol on the Current Therapeutic Regimen Used for the Treatment of Hemorrhagic Stroke",TERMINATED,,PHASE4,20.0,ACTUAL,Cristália Produtos Químicos Farmacêuticos Ltda.,,2.0,,Low enrollement,f,,,,f,f,f,,,,,,,,,,,2024-10-16 22:59:31.617874,2024-10-16 22:59:31.617874,INDUSTRY,,,,,,,2021,0.0
NCT02653131,,2016-01-10,,,2020-04-13,2016-01-10,2016-01-12,ESTIMATED,,,,,,,2020-04-13,2020-04-15,ACTUAL,2016-01,,2016-01-31,2020-04,2020-04-30,2020-04,ACTUAL,2020-04-30,2020-04,ACTUAL,2020-04-30,,INTERVENTIONAL,DPP-4,,The Use of DPP-4 Inhibitors in Short Bowel Syndrome,The Use of Dipeptidyl Peptidase-4 Inhibitor Influences the Absorption of Intestine in Short Bowel Syndrome,TERMINATED,,PHASE4,8.0,ACTUAL,Stanley Dudrick's Memorial Hospital,,2.0,,too many side-effects,f,,,,f,,,,,,,,,,,NO,All data is a part of a research,2024-10-16 11:10:27.881881,2024-10-16 11:10:27.881881,OTHER,,,,,,,2020,0.0
NCT04217590,,2020-01-02,2022-12-22,,2023-03-02,2020-01-02,2020-01-03,ACTUAL,2023-03-02,2023-03-28,ACTUAL,,,,2023-03-02,2023-03-28,ACTUAL,2020-11-16,ACTUAL,2020-11-16,2023-02,2023-02-28,2022-01-03,ACTUAL,2022-01-03,2022-01-03,ACTUAL,2022-01-03,,INTERVENTIONAL,DIALIZE China,"Baseline analysis was based on all patients in the full analysis set (FAS), which comprised all patients randomized. Patients were included in the analysis in the treatment arm to which they were randomized, regardless of the treatment they received.",Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects,"A Phase 3b, Multicentre, Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects",COMPLETED,,PHASE3,134.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,t,f,,,t,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,INDUSTRY,,,,,,,2022,1.0
NCT04225026,,2020-01-08,2022-11-17,,2023-03-22,2020-01-08,2020-01-13,ACTUAL,2023-03-22,2023-03-23,ACTUAL,,,,2023-03-22,2023-03-23,ACTUAL,2019-12-19,ACTUAL,2019-12-19,2022-06,2022-06-30,2022-03-27,ACTUAL,2022-03-27,2021-12-28,ACTUAL,2021-12-28,,INTERVENTIONAL,,The primary efficacy population includes all subjects who received at least one dose of GC4419 and either a.) completed their radiation therapy course of treatment or b.) discontinued their radiation therapy course of treatment but are known to have had acute radiation esophagitis.,Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer,A Phase 2a Open-Label Trial of the Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis in Subjects Receiving Chemoradiotherapy for Lung Cancer,TERMINATED,,PHASE2,39.0,ACTUAL,"Galera Therapeutics, Inc.",,1.0,,Lack of study enrollment,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 11:10:27.881881,2024-10-16 11:10:27.881881,INDUSTRY,,,,,,,2022,0.0
NCT02604433,,2015-10-21,2019-12-06,2018-05-23,2023-03-23,2015-11-10,2015-11-13,ESTIMATED,2020-01-23,2020-01-27,ACTUAL,2018-05-23,2018-05-25,ACTUAL,2023-03-23,2023-04-18,ACTUAL,2016-05-02,ACTUAL,2016-05-02,2023-03,2023-03-31,2021-01-05,ACTUAL,2021-01-05,2021-01-05,ACTUAL,2021-01-05,,INTERVENTIONAL,BELIEVE,All randomized participants,An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (β) Thalassemia,"A Phase 3, Double-Blind, Placebo Controlled Multicenter Study to Determine the Efficacy and Safety of Luspatercept (ACE-536) in Adults With Transfusion Dependent Beta (B)-Thalassemia",COMPLETED,,PHASE3,336.0,ACTUAL,Celgene,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,INDUSTRY,,,,,,,2021,1.0
NCT04784559,,2021-03-04,,,2023-03-07,2021-03-04,2021-03-05,ACTUAL,,,,,,,2023-03-07,2023-03-09,ACTUAL,2021-06-04,ACTUAL,2021-06-04,2023-03,2023-03-31,2023-03-01,ACTUAL,2023-03-01,2023-03-01,ACTUAL,2023-03-01,,INTERVENTIONAL,Neptuno,,Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection,"A Phase 3, Multicentre, Randomised, Controlled Trial to Determine the Efficacy and Safety of Two Dose Levels of Plitidepsin Versus Control in Adult Patient Requiring Hospitalisation for Management of Moderate COVID-19 Infection",TERMINATED,,PHASE3,205.0,ACTUAL,PharmaMar,,3.0,,"Sponsor has decided to end the study prematurely based on significant difficulties in the recruitment of patients, despite the implementation of corrective measures that still failed to increase the accrual rate required for a feasible completion.",f,,,,t,f,f,,,,,,,,,,,2024-10-16 11:10:27.881881,2024-10-16 11:10:27.881881,INDUSTRY,,,,,,,2023,0.0
NCT03040986,,2017-02-01,2020-10-18,,2021-01-20,2017-02-01,2017-02-02,ESTIMATED,2020-12-16,2021-01-11,ACTUAL,,,,2021-01-20,2021-02-09,ACTUAL,2017-07-21,ACTUAL,2017-07-21,2021-01,2021-01-31,2020-10-15,ACTUAL,2020-10-15,2018-08-10,ACTUAL,2018-08-10,,INTERVENTIONAL,,,Selumetinib Sulfate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12R Mutations,A Phase II Study of Selumetinib (AZD6244) for the Treatment of Advanced Pancreas Cancer Harboring KRAS G12R Mutations,COMPLETED,,PHASE2,8.0,ACTUAL,National Cancer Institute (NCI),,1.0,,,,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,NIH,,,,,,,2020,0.0
NCT02648477,,2016-01-05,2023-02-28,,2024-02-20,2016-01-05,2016-01-07,ESTIMATED,2023-03-28,2023-04-19,ACTUAL,,,,2024-02-20,2024-03-19,ACTUAL,2016-03-28,ACTUAL,2016-03-28,2024-02,2024-02-29,2023-12-30,ACTUAL,2023-12-30,2022-04-01,ACTUAL,2022-04-01,,INTERVENTIONAL,,,Pembrolizumab and Doxorubicin Hydrochloride or Anti-Estrogen Therapy in Treating Patients With Triple-Negative or Hormone Receptor-Positive Metastatic Breast Cancer,MK-3475 (Pembrolizumab) in Combination With an Anthracycline or Anti-estrogen Therapy in Patients With Triple Negative and Hormone Receptor Positive (HR+ HER2-) Metastatic Breast Cancer,COMPLETED,,PHASE2,30.0,ACTUAL,City of Hope Medical Center,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 22:59:31.617874,2024-10-16 22:59:31.617874,OTHER,,,,,,,2023,0.0
NCT04856904,,2021-04-20,2024-03-15,,2024-06-10,2021-04-20,2021-04-23,ACTUAL,2024-06-10,2024-06-11,ACTUAL,,,,2024-06-10,2024-06-11,ACTUAL,2021-05-28,ACTUAL,2021-05-28,2023-12,2023-12-31,2023-06-30,ACTUAL,2023-06-30,2023-02-08,ACTUAL,2023-02-08,,INTERVENTIONAL,START,Intent to treat (ITT) population included all randomized partcipants.,Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation,Evaluation of the Risk of Atrophic Acne Scar Formation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 μg/g Cream Versus Vehicle Cream Over 24 Weeks,COMPLETED,,PHASE4,121.0,ACTUAL,Galderma R&D,,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,INDUSTRY,,,,,,,2023,1.0
NCT04855266,,2021-04-19,,,2023-06-12,2021-04-19,2021-04-22,ACTUAL,,,,,,,2023-06-12,2023-06-13,ACTUAL,2021-04,ESTIMATED,2021-04-30,2023-06,2023-06-30,2023-05,ESTIMATED,2023-05-31,2023-05,ESTIMATED,2023-05-31,,INTERVENTIONAL,,,Iron Sucrose in Patients With Iron Deficiency and POTS,"A Randomized, Controlled, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Intravenous Iron Sucrose in Patients With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)",WITHDRAWN,,PHASE2,0.0,ACTUAL,Mayo Clinic,,2.0,,Unable to recruit participants,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,OTHER,,,,,,,2023,0.0
NCT02592551,,2015-10-19,2021-10-07,,2022-09-16,2015-10-29,2015-10-30,ESTIMATED,2021-12-14,2022-01-13,ACTUAL,,,,2022-09-16,2022-09-29,ACTUAL,2016-05-11,ACTUAL,2016-05-11,2022-09,2022-09-30,2022-09-01,ACTUAL,2022-09-01,2019-08-06,ACTUAL,2019-08-06,,INTERVENTIONAL,,The baseline analysis population includes all participants enrolled.,MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma,Window Of Opportunity Phase II Study Of MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma,COMPLETED,,PHASE2,24.0,ACTUAL,Baylor College of Medicine,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2022,1.0
NCT04278417,,2020-02-18,2024-06-24,,2024-09-17,2020-02-18,2020-02-20,ACTUAL,2024-07-30,2024-08-20,ACTUAL,,,,2024-09-17,2024-10-02,ACTUAL,2020-11-19,ACTUAL,2020-11-19,2024-09,2024-09-30,2024-08-19,ACTUAL,2024-08-19,2023-10-30,ACTUAL,2023-10-30,,INTERVENTIONAL,CONDOR,,Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy,"A 96-week, Two-arm, Randomized, Single-masked, Multi-center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy",COMPLETED,,PHASE3,689.0,ACTUAL,Novartis,,2.0,,,f,,,,f,t,f,,,,,,,,https://clinicalstudydatarequest.com/,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,INDUSTRY,,,,,,,2024,1.0
NCT04329091,,2020-03-30,2022-12-23,,2023-02-22,2020-03-30,2020-04-01,ACTUAL,2023-02-22,2023-02-24,ACTUAL,,,,2023-02-22,2023-02-24,ACTUAL,2020-10-16,ACTUAL,2020-10-16,2023-02,2023-02-28,2021-12-20,ACTUAL,2021-12-20,2021-12-20,ACTUAL,2021-12-20,,INTERVENTIONAL,,,Implications of Anesthetics on Sleep Consolidation,Implications of Anesthetics on Sleep Consolidation,TERMINATED,,PHASE4,9.0,ACTUAL,University of Chicago,,1.0,,Lack of participant recruitment,f,,,,f,t,f,,,f,,,,,,NO,No IPD will be shared with other researchers,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,OTHER,,,,,,,2021,0.0
NCT04540627,,2020-07-24,2021-06-22,,2021-09-07,2020-09-01,2020-09-07,ACTUAL,2021-09-07,2021-10-04,ACTUAL,,,,2021-09-07,2021-10-04,ACTUAL,2020-07-06,ACTUAL,2020-07-06,2021-09,2021-09-30,2020-10-23,ACTUAL,2020-10-23,2020-10-23,ACTUAL,2020-10-23,,INTERVENTIONAL,,,Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated With RSV,"A Double-Blind, Randomised, Placebo-Controlled Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated With Respiratory Syncytial Virus (RSV)",COMPLETED,,PHASE1,56.0,ACTUAL,mAbxience Research S.L.,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 11:10:27.881881,2024-10-16 11:10:27.881881,INDUSTRY,,,,,,,2020,1.0
NCT04498247,,2020-08-03,2021-12-20,,2021-12-20,2020-08-03,2020-08-04,ACTUAL,2021-12-20,2021-12-23,ACTUAL,,,,2021-12-20,2021-12-23,ACTUAL,2020-08-27,ACTUAL,2020-08-27,2021-12,2021-12-31,2021-03-05,ACTUAL,2021-03-05,2021-03-05,ACTUAL,2021-03-05,,INTERVENTIONAL,,,"A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001)","A Phase 1/Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Safety, Tolerability and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Younger and Older Participants",TERMINATED,,PHASE1/PHASE2,263.0,ACTUAL,Merck Sharp & Dohme LLC,The study was terminated based on an interim assessment of immunogenicity indicating that V591 was not predicted to provide adequate protection against disease caused by SARS-CoV-2.,10.0,,The study was terminated based on an interim assessment of immunogenicity,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,INDUSTRY,,,,,,,2021,0.0
NCT04130698,,2019-10-09,,,2022-10-24,2019-10-15,2019-10-17,ACTUAL,,,,,,,2022-10-24,2022-10-25,ACTUAL,2019-06-01,ACTUAL,2019-06-01,2022-10,2022-10-31,2022-07-31,ACTUAL,2022-07-31,2022-07-31,ESTIMATED,2022-07-31,,INTERVENTIONAL,BREATH,,Comparing Two Treatments That Both Target Smoking Cessation and Weight Loss at the Same Time.,Biobehavioral Regulation to Extinguish Smoking While Treating Another Health Risk,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Rhode Island College,,2.0,,"Due to COVID-19, public health guidelines prevent in-person group meetings.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,OTHER,,,,,,,2022,0.0
NCT03045341,,2017-02-03,2022-07-22,,2023-03-03,2017-02-03,2017-02-07,ESTIMATED,2022-11-23,2022-12-20,ACTUAL,,,,2023-03-03,2023-03-08,ACTUAL,2017-02-27,ACTUAL,2017-02-27,2023-03,2023-03-31,2022-12-16,ACTUAL,2022-12-16,2021-07-23,ACTUAL,2021-07-23,,INTERVENTIONAL,,,Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment,Behavioral and Pharmacologic Treatment of Binge Eating and Obesity,COMPLETED,,PHASE2/PHASE3,136.0,ACTUAL,Yale University,,4.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,OTHER,,,,,,,2022,1.0
NCT03806231,,2018-10-25,2021-08-11,,2021-08-11,2019-01-14,2019-01-16,ACTUAL,2021-08-11,2021-09-05,ACTUAL,,,,2021-08-11,2021-09-05,ACTUAL,2019-08-07,ACTUAL,2019-08-07,2021-08,2021-08-31,2020-04-11,ACTUAL,2020-04-11,2019-12-05,ACTUAL,2019-12-05,,INTERVENTIONAL,,,A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening,"A Trial of Cervidil (Dinoprostone, Prostaglandin E2 (PGE2), Insert) for Outpatient Pre-induction of Cervical Ripening in Women at 39.0-41.6 Weeks Gestation",TERMINATED,,PHASE3,8.0,ACTUAL,"Intermountain Health Care, Inc.",Trial terminated prior to meeting sufficient sample size for outcome analyses.,2.0,,Sponsor declined to provide further funding/product support.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,OTHER,,,,,,,2020,0.0
NCT05386784,,2022-05-18,,,2024-04-15,2022-05-18,2022-05-23,ACTUAL,,,,,,,2024-04-15,2024-04-17,ACTUAL,2020-12-16,ACTUAL,2020-12-16,2024-04,2024-04-30,2022-07-14,ACTUAL,2022-07-14,2022-07-14,ACTUAL,2022-07-14,,INTERVENTIONAL,,,Effect of Raloxifene Plus Cholecalciferol and Cholecalciferol Alone on the Bone Mineral Density in Postmenopausal Women With Osteopenia,Effect of Raloxifene Plus Cholecalciferol and Cholecalciferol Alone on the Bone Mineral Density in Postmenopausal Women With Osteopenia: an 1-year Randomized Controlled Trial,COMPLETED,,PHASE4,112.0,ACTUAL,Yonsei University,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,OTHER,,,,,,,2022,1.0
NCT03456999,,2018-03-01,,,2018-12-11,2018-03-01,2018-03-07,ACTUAL,,,,,,,2018-12-11,2018-12-13,ACTUAL,2018-10-15,ESTIMATED,2018-10-15,2018-12,2018-12-31,2020-11-16,ESTIMATED,2020-11-16,2020-07-13,ESTIMATED,2020-07-13,,INTERVENTIONAL,,,"Determine the Safety, Tolerability, and Efficacy of MAU868 for the Prevention of BK Virus Infection in Kidney Transplant Recipients","A Randomized, Double Blind, Placebo Controlled Study to Assess the Safety, Tolerability, and Efficacy of MAU868 for the Prevention of Allograft-threatening BK Virus Infection in Kidney Transplant Recipients",WITHDRAWN,,PHASE2,0.0,ACTUAL,Novartis,,2.0,,company decision,f,,,,f,t,f,,,,,,,,,,,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,INDUSTRY,,,,,,,2020,0.0
NCT04487834,,2020-07-22,2023-01-31,,2023-11-20,2020-07-22,2020-07-27,ACTUAL,2023-11-20,2023-11-22,ACTUAL,,,,2023-11-20,2023-11-22,ACTUAL,2020-04-16,ACTUAL,2020-04-16,2023-11,2023-11-30,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,Effects of Vivatlac Baby on Crying Behavior of Colicky Babies,Effects of Simethicone and Vivatlac Baby in Infantile Colic,COMPLETED,,PHASE2,87.0,ACTUAL,The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz,"A limitation of the study is the use of parental diaries to measure infants' crying behavior. Using paper diaries is not without problems. Nevertheless, it has been shown that paper diary recordings of common infant behavior can provide reasonably good estimates of durations, while behavioral frequencies may be underestimated. Another major limitation of the study is that medication was not blinded.",2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,OTHER,,,,,,,2020,1.0
NCT04390763,,2020-05-14,,,2024-05-15,2020-05-14,2020-05-18,ACTUAL,,,,,,,2024-05-15,2024-05-17,ACTUAL,2020-10-16,ACTUAL,2020-10-16,2024-05,2024-05-31,2024-05-02,ACTUAL,2024-05-02,2024-04-26,ACTUAL,2024-04-26,,INTERVENTIONAL,daNIS-1,,Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC),"A Phase II, Open Label, Randomized, Parallel Arm Study of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy Gemcitabine/Nab-paclitaxel, and Gemcitabine/Nab-paclitaxel Alone in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)",TERMINATED,,PHASE2,164.0,ACTUAL,Novartis,,4.0,,"The study was early terminated following the NIS793 treatment halt and urgent safety measure issued in July 2023, as the continued evaluation of Standard of Care alone will not support the original purpose of this phase 2 clinical trial.",f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,INDUSTRY,,,,,,,2024,0.0
NCT05673876,,2022-12-21,,,2024-01-29,2022-12-21,2023-01-06,ACTUAL,,,,,,,2024-01-29,2024-01-30,ACTUAL,2023-04-06,ACTUAL,2023-04-06,2024-01,2024-01-31,2024-01-15,ACTUAL,2024-01-15,2024-01-15,ACTUAL,2024-01-15,,INTERVENTIONAL,,,A Study to Assess the Safety and Pharmacokinetics of GDC-8264 in Combination With Standard of Care in Participants With Acute Graft-Versus-Host Disease (aGVHD),"A Phase Ib, Open-label, Randomized, Dose-finding, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of GDC-8264 in Combination With Standard of Care in the Treatment of Acute Graft-versus-Host Disease in Patients Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation",TERMINATED,,PHASE1,7.0,ACTUAL,"Genentech, Inc.",,2.0,,Study was terminated for business reasons. There were no safety or efficacy concerns regarding the study or study drug in the decision to terminate the study.,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,INDUSTRY,,,,,,,2024,0.0
NCT05327361,,2022-03-14,2024-01-17,,2024-03-05,2022-04-06,2022-04-14,ACTUAL,2024-03-05,2024-04-03,ACTUAL,,,,2024-03-05,2024-04-03,ACTUAL,2022-03-22,ACTUAL,2022-03-22,2024-03,2024-03-31,2023-03-06,ACTUAL,2023-03-06,2023-01-17,ACTUAL,2023-01-17,,INTERVENTIONAL,,,LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP),Evaluation of the Depigmenting Effect of Liftactiv B3 Serum (Split Face) in Patients With Mild to Moderate Facial Post-acne PIHP for 3 Months,TERMINATED,,PHASE2,13.0,ACTUAL,University of Miami,,2.0,,Enrollment timeline ended,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,OTHER,,,,,,,2023,0.0
NCT01376778,,2011-06-15,2022-10-21,,2023-01-17,2011-06-16,2011-06-20,ESTIMATED,2023-01-17,2023-02-02,ACTUAL,,,,2023-01-17,2023-02-02,ACTUAL,2012-04,,2012-04-30,2023-01,2023-01-31,2021-06-30,ACTUAL,2021-06-30,2019-10,ACTUAL,2019-10-31,,INTERVENTIONAL,CMV,,A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV),A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV),COMPLETED,,PHASE3,399.0,ACTUAL,The George Washington University Biostatistics Center,,2.0,,,f,,,,t,,,,,,,,,,,YES,The dataset will be shared per NIH policy after the completion and publication of the main analyses. Requests for datasets can be sent to mfmudatasets@bsc.gwu.edu.,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2021,1.0
NCT03334409,,2017-11-03,2022-02-04,,2022-03-18,2017-11-03,2017-11-07,ACTUAL,2022-03-14,2022-03-16,ACTUAL,,,,2022-03-18,2022-03-31,ACTUAL,2018-02-16,ACTUAL,2018-02-16,2020-10,2020-10-31,2021-03-13,ACTUAL,2021-03-13,2021-03-13,ACTUAL,2021-03-13,,INTERVENTIONAL,,,Pazopanib Hydrochloride With or Without Ascorbic Acid in Treating Patients With Kidney Cancer That Is Metastatic or Cannot Be Removed by Surgery,"Randomized, Phase II Trial of Intravenous Ascorbic Acid (Vitamin C) as an Adjunct to Pazopanib in the First-Line or Post-Immunotherapy Setting for Metastatic or Unresectable Clear Cell Renal Cell Carcinoma (ccRCC)",TERMINATED,,PHASE2,5.0,ACTUAL,Academic and Community Cancer Research United,,2.0,,Due to loss of funding from the private foundation source,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,OTHER,,,,,,,2021,0.0
NCT03684694,,2018-09-11,2023-11-21,,2024-01-10,2018-09-24,2018-09-26,ACTUAL,2024-01-10,2024-02-06,ACTUAL,,,,2024-01-10,2024-02-06,ACTUAL,2018-12-01,ACTUAL,2018-12-01,2024-01,2024-01-31,2022-11-08,ACTUAL,2022-11-08,2022-11-08,ACTUAL,2022-11-08,,INTERVENTIONAL,,"Measured in the safety analysis set, which included all participants who received study drug.",Safety and Efficacy Study of Loncastuximab Tesirine + Ibrutinib in Diffuse Large B-Cell or Mantle Cell Lymphoma,A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Loncastuximab Tesirine and Ibrutinib in Patients With Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma (LOTIS-3),TERMINATED,,PHASE1/PHASE2,136.0,ACTUAL,ADC Therapeutics S.A.,,4.0,,Administrative decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,INDUSTRY,,,,,,,2022,0.0
NCT03600896,,2018-07-03,,,2019-01-08,2018-07-16,2018-07-26,ACTUAL,,,,,,,2019-01-08,2019-01-10,ACTUAL,2018-11,ESTIMATED,2018-11-30,2019-01,2019-01-31,2024-11,ESTIMATED,2024-11-30,2023-11,ESTIMATED,2023-11-30,,INTERVENTIONAL,,,Recombinant Human Interleukin-7 (CYT107) to Promote T-Cell Recovery After Cord Blood Transplantation,Recombinant Human Interleukin-7 (CYT107) to Promote T-Cell Recovery After Cord Blood Transplantation,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,Supply issues from Sponsor,f,,,,f,t,f,,,,,,,,,,,2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,OTHER,,,,,,,2024,0.0
NCT04034225,,2019-07-16,2022-08-11,,2023-03-23,2019-07-23,2019-07-26,ACTUAL,2022-12-06,2022-12-30,ACTUAL,,,,2023-03-23,2023-03-24,ACTUAL,2019-11-11,ACTUAL,2019-11-11,2023-03,2023-03-31,2021-06-28,ACTUAL,2021-06-28,2021-06-28,ACTUAL,2021-06-28,,INTERVENTIONAL,,,Addition of SNS-301 to Checkpoint Inhibitor Treatment in Metastatic/Recurrent SCCHN,"An Open-Label, Multi-Center Trial of SNS-301 Added to Pembrolizumab in Patients With Locally Advanced Unresectable or Metastatic/Recurrent Squamous Cell Carcinoma of the Head and Neck",TERMINATED,,PHASE1/PHASE2,25.0,ACTUAL,"Sensei Biotherapeutics, Inc.",The study stopped prematurely for lack of efficacy 25 patients were enrolled. Lab analyzes were not performed.,1.0,,Terminated by the sponsor,f,,,,f,t,f,,,,,,Beginning 9 months and ending 36 months following article publication.,"Access will be considered to researchers who provide a methodologically sound proposal. Analysis must achieve the aims outlined in the approved proposal Proposals should be directed to info@senseibio.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 36 months following article publication.",,YES,"Individual participant data that underline the results reported in the article, after deidentification (text, tables, figures and appendices) will be shared to researchers who have provide a methodologically sound proposal and sign a data access agreement.",2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,INDUSTRY,,,,,,,2021,0.0
NCT03202537,,2017-06-21,,,2023-01-11,2017-06-27,2017-06-28,ACTUAL,,,,,,,2023-01-11,2023-01-12,ACTUAL,2017-07-01,ACTUAL,2017-07-01,2023-01,2023-01-31,2022-07-31,ACTUAL,2022-07-31,2022-07-31,ACTUAL,2022-07-31,,INTERVENTIONAL,,,Effectiveness of Physiologic Testing in PPI Non-Responders,Effectiveness of Physiologic Testing in PPI Non-Responders,COMPLETED,,EARLY_PHASE1,240.0,ACTUAL,Northwestern University,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,OTHER,,,,,,,2022,1.0
NCT03290196,,2017-09-18,,,2020-03-04,2017-09-19,2017-09-21,ACTUAL,,,,,,,2020-03-04,2020-03-06,ACTUAL,2015-09-03,ACTUAL,2015-09-03,2020-03,2020-03-31,2022-07,ESTIMATED,2022-07-31,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,,,"The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics","The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics",SUSPENDED,,PHASE4,60.0,ESTIMATED,Andrews Research & Education Foundation,,1.0,,Patients pain was not regulated well with this product.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,OTHER,,,,,,,2022,0.0
NCT04409262,,2020-05-28,2022-01-28,,2022-01-28,2020-05-28,2020-06-01,ACTUAL,2022-01-28,2022-02-14,ACTUAL,,,,2022-01-28,2022-02-14,ACTUAL,2020-06-16,ACTUAL,2020-06-16,2022-01,2022-01-31,2021-03-08,ACTUAL,2021-03-08,2021-02-01,ACTUAL,2021-02-01,,INTERVENTIONAL,REMDACTA,,A Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Participants With Severe COVID-19 Pneumonia,"A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia",COMPLETED,,PHASE3,649.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,INDUSTRY,,,,,,,2021,1.0
NCT04201821,,2019-12-13,2024-04-03,2023-11-07,2024-06-11,2019-12-13,2019-12-17,ACTUAL,2024-06-11,2024-06-12,ACTUAL,,2024-06-12,ACTUAL,2024-06-11,2024-06-12,ACTUAL,2021-01-14,ACTUAL,2021-01-14,2024-06,2024-06-30,2023-01-18,ACTUAL,2023-01-18,2023-01-18,ACTUAL,2023-01-18,,INTERVENTIONAL,FMT for FI,,Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women,Fecal Microbial Transplantation (FMT) For the Treatment of Fecal Incontinence in Women,TERMINATED,,PHASE1/PHASE2,10.0,ACTUAL,University of Pennsylvania,,1.0,,Administrative reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,OTHER,,,,,,,2023,0.0
NCT02901041,,2016-08-29,2023-01-03,,2023-05-19,2016-09-10,2016-09-15,ESTIMATED,2023-04-14,2023-05-06,ACTUAL,,,,2023-05-19,2023-06-18,ACTUAL,2017-09-21,ACTUAL,2017-09-21,2023-05,2023-05-31,2022-01-04,ACTUAL,2022-01-04,2022-01-04,ACTUAL,2022-01-04,,INTERVENTIONAL,,,Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism,Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism,COMPLETED,,PHASE3,81.0,ACTUAL,Boston University Charles River Campus,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,OTHER,,,,,,,2022,1.0
NCT05283304,,2022-02-28,,,2024-02-12,2022-03-11,2022-03-16,ACTUAL,,,,,,,2024-02-12,2024-02-14,ACTUAL,2023-03-24,ACTUAL,2023-03-24,2024-02,2024-02-29,2023-11-19,ACTUAL,2023-11-19,2023-10-20,ACTUAL,2023-10-20,,INTERVENTIONAL,CTN-0110,,Monthly Injectable BUP for MA Use Disorder (MURB) Trial,"Randomized, Double-blind, Placebo-controlled Trial of Monthly Injectable Buprenorphine (BUP) for Methamphetamine (MA) Use Disorder",TERMINATED,,PHASE2,18.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,Side effects of medication,f,,,,t,t,f,,,f,,,After the study is complete and the data is analyzed,Study-specific de-identification notes will be posted on the website (URL provided here),https://datashare.nida.nih.gov/,YES,"Data from this study will be available to researchers on the website https://datashare.nida.nih.gov/ after the study is complete and the data is analyzed. This website will not include information that can identify individual study participants. The following information will be posted: Study protocol, reference to study publication of primary outcome, data sets (SAS and ASCII ), annotated case report forms, define file (also known as Data Dictionary), study-specific de-identification notes. Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the National Institute on Drug Abuse (NIDA) Data Share Agreement.",2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,OTHER,,,,,,,2023,0.0
NCT04212026,,2019-12-19,,,2023-07-14,2019-12-23,2019-12-26,ACTUAL,,,,,,,2023-07-14,2023-07-18,ACTUAL,2020-06-28,ACTUAL,2020-06-28,2023-07,2023-07-31,2023-07-12,ACTUAL,2023-07-12,2023-07-12,ACTUAL,2023-07-12,,INTERVENTIONAL,,,Irreversible Electroporation (IRE) Followed by Nivolumab in Patients With Metastatic Pancreatic Cancer.,Irreversible Electroporation (IRE) Followed by Nivolumab in Patients With Metastatic Pancreatic Cancer: a Multicenter Single-arm Phase II Trial,TERMINATED,,PHASE2,8.0,ACTUAL,"University Hospital, Basel, Switzerland",,1.0,,difficult recruitement,f,,,,t,f,f,,,,,,,,,,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,OTHER,,,,,,,2023,0.0
NCT04115488,,2019-09-10,2023-04-28,,2023-06-13,2019-10-01,2019-10-04,ACTUAL,2023-06-13,2023-07-03,ACTUAL,,,,2023-06-13,2023-07-03,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2023-06,2023-06-30,2022-02-07,ACTUAL,2022-02-07,2021-08-23,ACTUAL,2021-08-23,,INTERVENTIONAL,Antelope,The Full Analysis Set (FAS) Population includes all patients who were randomized and have received at least one infusion of the study drug.,Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®,Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS),COMPLETED,,PHASE3,265.0,ACTUAL,Polpharma Biologics S.A.,,2.0,,,,,,,,t,f,,,,,,,,,NO,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,INDUSTRY,,,,,,,2022,1.0
NCT03725033,,2018-10-29,2020-12-18,,2021-01-14,2018-10-29,2018-10-30,ACTUAL,2020-12-18,2021-01-14,ACTUAL,,,,2021-01-14,2021-02-04,ACTUAL,2018-10-10,ACTUAL,2018-10-10,2019-11,2019-11-30,2020-03-23,ACTUAL,2020-03-23,2020-03-23,ACTUAL,2020-03-23,,INTERVENTIONAL,,,Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance,Multicentre Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance,COMPLETED,,PHASE3,538.0,ACTUAL,Materia Medica Holding,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,INDUSTRY,,,,,,,2020,1.0
NCT01759212,,2012-12-18,,,2022-07-20,2012-12-27,2013-01-03,ESTIMATED,,,,,,,2022-07-20,2022-07-25,ACTUAL,2012-10,,2012-10-31,2022-07,2022-07-31,2022-07,ACTUAL,2022-07-31,2022-07,ACTUAL,2022-07-31,,INTERVENTIONAL,,,Left Ventricular Assist Device Combined With Allogeneic Mesenchymal Stem Cells Implantation in Patients With End-stage Heart Failure.,Safety and Efficacy of Intramyocardial Implantation of Allogeneic Mesenchymal Stem Cells in Patients With End-stage Heart Failure Undergoing Left Ventricular Assist Device Implantation,TERMINATED,,PHASE2/PHASE3,1.0,ACTUAL,AHEPA University Hospital,,1.0,,Lack of eligible patients,f,,,,f,,,,,,,,,,,,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,OTHER,,,,,,,2022,0.0
NCT03245970,,2017-08-08,,,2020-08-03,2017-08-08,2017-08-10,ACTUAL,,,,,,,2020-08-03,2020-08-05,ACTUAL,2017-04-24,ACTUAL,2017-04-24,2020-08,2020-08-31,2020-02-29,ACTUAL,2020-02-29,2020-02-29,ACTUAL,2020-02-29,,INTERVENTIONAL,,,Impedance Cardiography to Decrease the Risk of Preeclampsia,Use of Impedance Cardiography to Decrease the Risk of Preeclampsia,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Tennessee Medical Center,,2.0,,Investigator retired. Other investigators did not want to continue study.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,OTHER,,,,,,,2020,0.0
NCT02683941,,2015-09-21,2021-09-30,2021-02-26,2022-06-16,2016-02-16,2016-02-17,ESTIMATED,2021-09-30,2021-10-29,ACTUAL,2021-02-26,2021-03-02,ACTUAL,2022-06-16,2022-07-06,ACTUAL,2017-03-06,ACTUAL,2017-03-06,2022-06,2022-06-30,2020-02-28,ACTUAL,2020-02-28,2020-02-28,ACTUAL,2020-02-28,,INTERVENTIONAL,SPINET,"The intention to treat (ITT) population included all randomised subjects. Subjects were analysed as randomised, regardless of the treatment received.",Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours,"A Phase 3, Prospective, Randomized, Double-blind, Multi-center Study of the Efficacy and Safety of Lanreotide Autogel®/Depot 120 mg Plus BSC vs. Placebo Plus BSC for Tumour Control in Subjects With Well Differentiated, Metastatic and/or Unresectable, Typical or Atypical, Lung Neuroendocrine Tumours",TERMINATED,,PHASE3,77.0,ACTUAL,Ipsen,The majority of subjects who entered the open-label treatment phase were withdrawn due to study termination by the sponsor.,2.0,,"National Comprehensive Cancer Network \& European Neuroendocrine Tumor Society guidelines (2015/2016) led to prescription of somatostatin analogues (SSAs) in this setting, thereby limiting recruitment.",f,,,,t,t,f,,,,,,,,,,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,INDUSTRY,,,,,,,2020,0.0
NCT04630067,,2020-10-27,,,2022-10-19,2020-11-13,2020-11-16,ACTUAL,,,,,,,2022-10-19,2022-10-20,ACTUAL,2020-11-17,ACTUAL,2020-11-17,2022-10,2022-10-31,2022-09-14,ACTUAL,2022-09-14,2022-09-14,ACTUAL,2022-09-14,,INTERVENTIONAL,,,"Assessment of Safety, Tolerability, Immunogenicity, and Pharmacokinetics of AZD3427","A Phase Ia/b Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Single Ascending Doses of AZD3427 in Healthy Volunteers and Multiple Ascending Doses of AZD3427 in Patients With Heart Failure (HFrEF and HF With EF ≥ 41%)",COMPLETED,,PHASE1,105.0,ACTUAL,AstraZeneca,,15.0,,,,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,INDUSTRY,,,,,,,2022,0.0
NCT04759365,,2021-02-15,,,2023-01-12,2021-02-15,2021-02-18,ACTUAL,,,,,,,2023-01-12,2023-01-17,ACTUAL,2021-06-02,ACTUAL,2021-06-02,2023-01,2023-01-31,2022-08-01,ACTUAL,2022-08-01,2022-08-01,ACTUAL,2022-08-01,,INTERVENTIONAL,,,"Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Oral ASN51 in Healthy Subjects and Subjects With Alzheimer's Disease","A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Oral ASN51 in Healthy Young Adult and Elderly Subjects and Elderly Subjects With Alzheimer's Disease",TERMINATED,,PHASE1,25.0,ACTUAL,Asceneuron S.A.,,2.0,,"Delays with sites, identifying/enrolling patients, impact of COVID, staffing, and duration",f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,INDUSTRY,,,,,,,2022,0.0
NCT04178642,,2019-11-04,,,2022-12-13,2019-11-25,2019-11-26,ACTUAL,,,,,,,2022-12-13,2022-12-14,ACTUAL,2020-09-22,ACTUAL,2020-09-22,2022-08,2022-08-31,2021-07-14,ACTUAL,2021-07-14,2021-07-14,ACTUAL,2021-07-14,,INTERVENTIONAL,LIDA-ADJ,,The Impact on Hepatic Recurrence After Adjuvant Chemotherapy With Intraarterial Infusion of Idarubicin-Lipiodol,Hepatocellular Carcinoma Under 3 cm Treated by Percutaneous Tumor Destruction: Multicentric Phase 2 Test Evaluating the Impact of Adjuvant Chemotherapy by Intra-arterial Infusion of Idarubicin-lipiodol on the Hepatic Recurrence,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University Hospital, Montpellier",,2.0,,no participants enrolled,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,OTHER,,,,,,,2021,0.0
NCT03311334,,2017-10-09,2023-12-21,,2024-03-25,2017-10-11,2017-10-17,ACTUAL,2024-03-25,2024-04-18,ACTUAL,,,,2024-03-25,2024-04-18,ACTUAL,2017-12-14,ACTUAL,2017-12-14,2024-03,2024-03-31,2022-11-29,ACTUAL,2022-11-29,2022-10-19,ACTUAL,2022-10-19,,INTERVENTIONAL,,,A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors,"A Phase 1b/2, Multicenter, Open-Label Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors Nivolumab or Pembrolizumab in Adult Patients With Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,47.0,ACTUAL,"Sumitomo Pharma America, Inc.",,2.0,,Sponsor's decision to terminate development of the program.,f,,,,,t,f,,,,,,,,,,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,INDUSTRY,,,,,,,2022,0.0
NCT03558958,,2018-06-05,,,2023-01-09,2018-06-05,2018-06-15,ACTUAL,,,,,,,2023-01-09,2023-01-11,ACTUAL,2018-08-08,ACTUAL,2018-08-08,2021-09,2021-09-30,2021-09-01,ACTUAL,2021-09-01,2021-09-01,ACTUAL,2021-09-01,,INTERVENTIONAL,,,Safety and Efficacy of P-188 NF in DMD Patients,"An Exploratory, Open-label Study to Assess the Effect of P-188 NF (Carmeseal-MD) on Safety, on Respiratory and Cardiac Dysfunction and on Upper Limb Strength in Non-ambulatory Patients With Duchenne Muscular Dystrophy (DMD)",TERMINATED,,PHASE2,2.0,ACTUAL,"Phrixus Pharmaceuticals, Inc.",,1.0,,Terminated due to lack of funding.,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,INDUSTRY,,,,,,,2021,0.0
NCT04409886,,2020-05-27,2021-05-25,,2021-06-25,2020-05-28,2020-06-01,ACTUAL,2021-06-25,2021-06-29,ACTUAL,,,,2021-06-25,2021-06-29,ACTUAL,2020-06-01,ACTUAL,2020-06-01,2021-06,2021-06-30,2021-01-31,ACTUAL,2021-01-31,2021-01-31,ACTUAL,2021-01-31,,INTERVENTIONAL,HBOT,,Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients,The Application of Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients - Randomized Controlled Trial,TERMINATED,,PHASE4,1.0,ACTUAL,Maimonides Medical Center,,1.0,,"This study is part of a larger national study. Only 1 patient was enrolled at Maimonides; Medical Center. The study was ended by the sponsor because the PI left; funding ended; , and no time, or personnel to do the study",f,,,,t,t,f,,,,,,,,,NO,Data will not be shared,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,OTHER,,,,,,,2021,0.0
NCT02702115,,2016-02-29,2022-11-03,,2023-01-06,2016-03-02,2016-03-08,ESTIMATED,2023-01-06,2023-01-26,ACTUAL,,,,2023-01-06,2023-01-26,ACTUAL,2017-05-24,ACTUAL,2017-05-24,2022-12,2022-12-31,2021-11-03,ACTUAL,2021-11-03,2021-11-03,ACTUAL,2021-11-03,,INTERVENTIONAL,,"The original protocol anticipated 9-12 subjects in 3 cohorts at ascending doses. However, enrollment ended after 3 subjects were enrolled in 2 cohorts. (No subjects were enrolled in cohort 3). After interim data analysis, the sponsor decided to stop enrollment in this study at 3 subjects enrolled, all adults, in 2 cohorts. (No subjects were enrolled in cohort 3) The sponsor continues to monitor the subjects in a 10-year,follow-up study ST-IVPRP-LT01 (NCT04628871).",Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-318 in Subjects With MPS I,"A Phase I / 2, Multicenter, Open-label, Single-dose, Dose-ranging Study to Assess the Safety and Tolerability of SB-318, a rAAV2/6-based Gene Transfer in Subjects With Mucopolysaccharidosis I (MPS I)",TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,Sangamo Therapeutics,"Continuous data will be summarized using the following descriptive statistics: the number of subjects (n), mean, standard deviation (SD), median, minimum and maximum, where appropriate. Categorial percentage (%) of subjects for each category, where appropriate.",3.0,,All three subjects dosed in the study have rolled over to the Long-Term Follow-up Study IVPRP-LT01 (NCT04628871),f,,,,t,t,f,,,,,,,,,,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,INDUSTRY,,,,,,,2021,0.0
NCT03343847,,2017-10-12,,,2018-01-17,2017-11-14,2017-11-17,ACTUAL,,,,,,,2018-01-17,2018-01-19,ACTUAL,2018-01-27,ESTIMATED,2018-01-27,2018-01,2018-01-31,2021-07-17,ESTIMATED,2021-07-17,2021-07-17,ESTIMATED,2021-07-17,,INTERVENTIONAL,,,Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Lymphoma.,A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Lymphomas,WITHDRAWN,,PHASE3,0.0,ACTUAL,Amgen,,2.0,,Study was not feasible,,,,,t,t,f,,,,,,,,,,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,INDUSTRY,,,,,,,2021,0.0
NCT03774251,,2018-12-04,,,2021-09-15,2018-12-11,2018-12-12,ACTUAL,,,,,,,2021-09-15,2021-09-20,ACTUAL,2019-10-01,ESTIMATED,2019-10-01,2021-09,2021-09-30,2021-01-01,ESTIMATED,2021-01-01,2020-01-01,ESTIMATED,2020-01-01,,INTERVENTIONAL,,,A Randomized Controlled Trial of Ultrasound-guided Platelet-Rich-Plasma (PRP) Injection Versus Extracorporeal Shock Wave Therapy (ESWT) for Great Trochanter Pain Syndrome (GTPS) With Gluteus Medius or Minimus Tendinopathy,A Randomized Controlled Trial of Ultrasound-guided Platelet-Rich-Plasma (PRP) Injection Versus Extracorporeal Shock Wave Therapy (ESWT) for Great Trochanter Pain Syndrome (GTPS) With Gluteus Medius or Minimus Tendinopathy,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Stanford University,,2.0,,Funding not secured,f,,,,t,t,t,t,,f,,,,,,NO,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,OTHER,,,,,,,2021,0.0
NCT03720418,,2018-10-16,,,2022-04-27,2018-10-24,2018-10-25,ACTUAL,,,,,,,2022-04-27,2022-05-03,ACTUAL,2018-10-17,ACTUAL,2018-10-17,2022-04,2022-04-30,2022-04-12,ACTUAL,2022-04-12,2022-04-12,ACTUAL,2022-04-12,,INTERVENTIONAL,SUNRISE-PD,,"Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral, Idiopathic Parkinson's Disease",A Phase I/II Safety and Dose Evaluation Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral Idiopathic Parkinson's Disease (SUNRISE-PD),TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,Sio Gene Therapies,,5.0,,"As a result of termination of development of OXB-102-01, it is no longer possible for Sio to either commence or to continue any related clinical trials.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,INDUSTRY,,,,,,,2022,0.0
NCT03859908,,2019-02-26,,,2023-05-08,2019-02-26,2019-03-01,ACTUAL,,,,,,,2023-05-08,2023-05-10,ACTUAL,2019-04-05,ACTUAL,2019-04-05,2023-05,2023-05-31,2021-01-27,ACTUAL,2021-01-27,2021-01-27,ACTUAL,2021-01-27,,INTERVENTIONAL,,,Comparison of Two Preoperative Antiseptic Solutions Alcohol Based in Abdominal Elective Surgeries,Iodine-Povidone Alcohol Compared to Chlorhexidine Alcohol as Preoperative Antiseptics in Major Abdominal Elective Clean Contaminated Surgery,TERMINATED,,PHASE4,18.0,ACTUAL,Universidad de El Salvador,,2.0,,Difficulties for recruitment due to COVID-19 pandemia and expiration of the material,f,,,,t,t,f,,,t,,,,,,NO,"If we decide to share IPD, it will be: study protocol, statistical analysis. Criteria to share: for systematic reviews we could share also individual data collected, after the study is published.~The study was stopped for recruitment due to COVID-19 emergency and elective surgeries diminished, and then the product used expired. Couldn't achieve not even 2% of Sample size",2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,OTHER,,,,,,,2021,0.0
NCT05107791,,2018-02-28,,,2024-05-18,2021-10-25,2021-11-04,ACTUAL,,,,,,,2024-05-18,2024-05-21,ACTUAL,2021-03-15,ACTUAL,2021-03-15,2024-05,2024-05-31,2021-08-31,ACTUAL,2021-08-31,2021-08-31,ACTUAL,2021-08-31,,INTERVENTIONAL,,,Effects of Stulln and Accommodative Training,Effects of Stulln Eye Drops and Accommodative Training on Accommodative Responses and Visual Fatigue,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Pacific University,,2.0,,unable to attend the drug for study,f,,,,f,t,f,,,f,,,,,,NO,IPD will not be shared.,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,OTHER,,,,,,,2021,0.0
NCT03382639,,2017-12-19,2023-12-08,2021-12-07,2024-01-30,2017-12-19,2017-12-26,ACTUAL,2024-01-30,2024-02-28,ACTUAL,,2024-02-28,ACTUAL,2024-01-30,2024-02-28,ACTUAL,2018-01-04,ACTUAL,2018-01-04,2024-01,2024-01-31,2021-01-12,ACTUAL,2021-01-12,2020-12-29,ACTUAL,2020-12-29,,INTERVENTIONAL,,The Full Analysis Set (FAS) will included all participants who were randomized and received at least 1 dose of the study drug during the Double-Blind Treatment Period.,A Study to Evaluate 3 Dose Levels of Luvadaxistat of Adults With Negative Symptoms of Schizophrenia,"A Phase 2, 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of 3 Dose Levels of TAK-831 in Adjunctive Treatment of Adult Subjects With Negative Symptoms of Schizophrenia",COMPLETED,,PHASE2,256.0,ACTUAL,Neurocrine Biosciences,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,INDUSTRY,,,,,,,2021,1.0
NCT04561960,,2020-09-16,,,2021-03-08,2020-09-22,2020-09-24,ACTUAL,,,,,,,2021-03-08,2021-03-10,ACTUAL,2020-09-30,ACTUAL,2020-09-30,2021-03,2021-03-31,2020-12-30,ACTUAL,2020-12-30,2020-12-10,ACTUAL,2020-12-10,,INTERVENTIONAL,,,Efficacy of Miswak in Oral Hygiene Maintenance,Efficacy of Miswak When Compared to Fluoridated Toothpaste for the Maintenance of Oral Hygiene in Young Adults,COMPLETED,,PHASE4,30.0,ACTUAL,Riyadh Elm University,,3.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,OTHER,,,,,,,2020,1.0
NCT02895945,,2016-08-15,2021-08-12,,2021-10-05,2016-09-06,2016-09-12,ESTIMATED,2021-10-05,2021-10-20,ACTUAL,,,,2021-10-05,2021-10-20,ACTUAL,2016-12-22,ACTUAL,2016-12-22,2021-10,2021-10-31,2021-01-22,ACTUAL,2021-01-22,2021-01-22,ACTUAL,2021-01-22,,INTERVENTIONAL,CHAWI,SAS comprised of all participants who received any amount of BAX 802.,BAX 802 in CHA With Inhibitors,"A Phase 3, Multicenter, Open-label Study of the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (BAX 802) in Subjects With Congenital Hemophilia A With Factor VIII Inhibitors Undergoing Surgical or Other Invasive Procedures",TERMINATED,,PHASE3,8.0,ACTUAL,Takeda,Study was discontinued as Takeda determined that the benefit/risk profile did not support continuation of the surgery study for this specific Congenital Hemophilia A with Inhibitors participant population.,1.0,,Takeda has determined that the benefit/risk profile does not support continuation of the surgery Study for this specific Congenital Hemophilia A with Inhibitors patient population.,f,,,,t,t,f,,,,,,,,,NO,De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants).,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,INDUSTRY,,,,,,,2021,0.0
NCT02296541,,2014-11-18,,,2023-04-20,2014-11-18,2014-11-20,ESTIMATED,,,,,,,2023-04-20,2023-04-24,ACTUAL,2014-12,,2014-12-31,2023-04,2023-04-30,2020-07-06,ACTUAL,2020-07-06,2016-11,ACTUAL,2016-11-30,,INTERVENTIONAL,,,"Evaluating the Safety and Immune Response to Three Different DNA HIV Vaccines Administered With a MVA-CMDR Boost Vaccine in Healthy, HIV-Uninfected Adults","A Phase 1 Randomized, Double-Blind, Placebo Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of 3 Different HIV-1 DNA Priming Regimens (Nat-B Env, CON-S Env, and Mosaic Env) With MVA-CMDR Boosts in Healthy, HIV-1-Uninfected Adults",COMPLETED,,PHASE1,105.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,6.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,NIH,,,,,,,2020,1.0
NCT05057897,,2021-09-15,,,2023-05-19,2021-09-24,2021-09-27,ACTUAL,,,,,,,2023-05-19,2023-05-22,ACTUAL,2022-01-31,ACTUAL,2022-01-31,2023-05,2023-05-31,2023-04-19,ACTUAL,2023-04-19,2023-04-19,ACTUAL,2023-04-19,,INTERVENTIONAL,VICTORIA,,"A Study of AZD1222, a Vaccine for the Prevention of COVID-19 in Immunocompromised Adults","A Phase IV Open-Label, Non-Randomized, Multi-Cohort, Multicenter Study in Previously Unvaccinated Immunocompromised Adults to Determine the Immunogenicity and Safety of AZD1222 Vaccine for the Prevention of COVID-19",TERMINATED,,PHASE4,34.0,ACTUAL,AstraZeneca,,6.0,,Removal of the commitment for Immune compromised study (D81111C00010) due to recruitment challenges.,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,INDUSTRY,,,,,,,2023,0.0
NCT05153148,,2021-11-26,2024-05-03,,2024-05-03,2021-12-09,2021-12-10,ACTUAL,2024-05-03,2024-05-31,ACTUAL,,,,2024-05-03,2024-05-31,ACTUAL,2022-01-06,ACTUAL,2022-01-06,2024-05,2024-05-31,2023-06-02,ACTUAL,2023-06-02,2023-05-04,ACTUAL,2023-05-04,,INTERVENTIONAL,,Full Analysis Set included all randomized participants who received at least one dose of study drug.,"A Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Participants With Active Psoriatic Arthritis","A Phase 2b, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Subjects With Active Psoriatic Arthritis",COMPLETED,,PHASE2,305.0,ACTUAL,Takeda,,4.0,,,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,INDUSTRY,,,,,,,2023,1.0
NCT04079803,,2019-08-26,2021-04-12,,2021-09-07,2019-09-04,2019-09-06,ACTUAL,2021-05-06,2021-06-01,ACTUAL,,,,2021-09-07,2021-09-29,ACTUAL,2019-09-09,ACTUAL,2019-09-09,2021-09,2021-09-30,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,,PTI-125 for Mild-to-moderate Alzheimer's Disease Patients,"A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multiple Dose, Biomarker and Safety Study of PTI-125 in Mild-to-moderate Alzheimer's Disease Patients",COMPLETED,,PHASE2,64.0,ACTUAL,"Cassava Sciences, Inc.",,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,INDUSTRY,,,,,,,2020,1.0
NCT03799198,,2019-01-08,2021-05-06,,2022-11-10,2019-01-08,2019-01-10,ACTUAL,2021-06-15,2021-06-18,ACTUAL,,,,2022-11-10,2022-11-14,ACTUAL,2019-01-07,ACTUAL,2019-01-07,2022-11,2022-11-30,2020-05-22,ACTUAL,2020-05-22,2020-05-22,ACTUAL,2020-05-22,,INTERVENTIONAL,,Full analysis set (FAS) comprised of all randomized participants.,Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity,Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity - a Pragmatic Randomized Trial,COMPLETED,,PHASE4,200.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://www.novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,INDUSTRY,,,,,,,2020,1.0
NCT04326439,,2020-03-13,2022-04-07,,2022-05-25,2020-03-27,2020-03-30,ACTUAL,2022-05-25,2022-06-15,ACTUAL,,,,2022-05-25,2022-06-15,ACTUAL,2020-01-24,ACTUAL,2020-01-24,2022-05,2022-05-31,2022-03-15,ACTUAL,2022-03-15,2022-03-15,ACTUAL,2022-03-15,,INTERVENTIONAL,,,AflacLL1901 (CHOA-AML),CHOA-AML: A Pilot Study for Newly Diagnosed Pediatric Patients With Acute Myeloid Leukemia (AML),TERMINATED,,PHASE2,8.0,ACTUAL,Emory University,,2.0,,"Due to unforeseen circumstances, the study team was limited in enrolling patients on this trial; thus, it was terminated.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,OTHER,,,,,,,2022,0.0
NCT04257656,,2020-01-31,,,2020-04-13,2020-02-03,2020-02-06,ACTUAL,,,,,,,2020-04-13,2020-04-15,ACTUAL,2020-02-06,ACTUAL,2020-02-06,2020-04,2020-04-30,2020-04-10,ACTUAL,2020-04-10,2020-03-30,ACTUAL,2020-03-30,,INTERVENTIONAL,,,A Trial of Remdesivir in Adults With Severe COVID-19,"A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir in Hospitalized Adult Patients With Severe COVID-19.",TERMINATED,,PHASE3,237.0,ACTUAL,Capital Medical University,,2.0,,"The epidemic of COVID-19 has been controlled well in China, no eligible patients can be enrolled at present.",f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,OTHER,,,,,,,2020,0.0
NCT06326138,,2024-03-11,,,2024-03-21,2024-03-21,2024-03-22,ACTUAL,,,,,,,2024-03-21,2024-03-22,ACTUAL,2024-03-11,ACTUAL,2024-03-11,2024-03,2024-03-31,2024-03-11,ACTUAL,2024-03-11,2024-03-11,ACTUAL,2024-03-11,,INTERVENTIONAL,EXPOSE,,Pharmacokinetics and Pharmacodynamics of Edoxaban Before and After Bariatric Surgery,Pharmacokinetics and Pharmacodynamics of Edoxaban in Subjects With Severe Obesity Before and After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass,WITHDRAWN,,PHASE1,0.0,ACTUAL,"Institut universitaire de cardiologie et de pneumologie de Québec, University Laval",,2.0,,No support form the sponsor,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,OTHER,,,,,,,2024,0.0
NCT05001854,,2021-07-08,,,2023-11-15,2021-08-03,2021-08-12,ACTUAL,,,,,,,2023-11-15,2023-11-18,ACTUAL,2022-03-31,ACTUAL,2022-03-31,2023-11,2023-11-30,2024-12,ESTIMATED,2024-12-31,2024-06,ESTIMATED,2024-06-30,,INTERVENTIONAL,FLUDROSEPSIS,,Hemodynamics Effects of Fludrocortisone on the Pressor Response to Noradrenaline Septic Shock Patients,Evaluation of the Hemodynamics Effects of Fludrocortisone on the Pressor Response to Noradrenaline in Septic Shock Patients,SUSPENDED,,PHASE2/PHASE3,40.0,ESTIMATED,Rennes University Hospital,,2.0,,study suspended until new therapeutic units are available,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,OTHER,,,,,,,2024,0.0
NCT02149823,,2014-05-21,,,2022-10-06,2014-05-23,2014-05-29,ESTIMATED,,,,,,,2022-10-06,2022-10-10,ACTUAL,2013-09,,2013-09-30,2022-10,2022-10-31,2022-06-14,ACTUAL,2022-06-14,2020-07,ACTUAL,2020-07-31,,INTERVENTIONAL,,,Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations,Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations,TERMINATED,,PHASE1,92.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,5.0,,All study proceedings stopped prematurely due to Covid-19 restrictions for intranasal formulations,f,,,,t,,,,,,,,,,,,,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,OTHER,,,,,,,2022,0.0
NCT04723186,,2021-01-22,,,2023-10-29,2021-01-22,2021-01-25,ACTUAL,,,,,,,2023-10-29,2023-10-31,ACTUAL,2020-12-02,ACTUAL,2020-12-02,2023-05,2023-05-31,2023-08-31,ACTUAL,2023-08-31,2023-08-31,ACTUAL,2023-08-31,,INTERVENTIONAL,,,MT1002 Phase II Study in ACS Patients With PCI,"Open-Label, Sequential-Dose Escalation/De-escalation Trial Testing MT1002 in Patients Undergoing PCI Due to Acute Coronary Syndrome With NSTEMI",TERMINATED,,PHASE2,6.0,ACTUAL,Shaanxi Micot Technology Limited Company,,1.0,,"The study was decided to be terminated due to commercial considerations,（not the safety issues of the product）.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 01:43:32.363503,2024-10-16 01:43:32.363503,INDUSTRY,,,,,,,2023,0.0
NCT04448756,,2020-06-25,2022-05-11,,2022-05-11,2020-06-25,2020-06-26,ACTUAL,2022-05-11,2022-06-06,ACTUAL,,,,2022-05-11,2022-06-06,ACTUAL,2020-07-29,ACTUAL,2020-07-29,2022-05,2022-05-31,2021-08-16,ACTUAL,2021-08-16,2021-08-16,ACTUAL,2021-08-16,,INTERVENTIONAL,,Safety analysis set included all participants who had received at least one dose of study intervention.,Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE),"A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of M5049 in Hospitalized Participants With COVID-19 Pneumonia (ANEMONE)",COMPLETED,,PHASE2,149.0,ACTUAL,EMD Serono,,3.0,,,f,,,,t,t,f,,,,,,Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union,Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.,http://bit.ly/IPD21,YES,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21",2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,INDUSTRY,,,,,,,2021,1.0
NCT03478163,,2018-03-12,2021-06-04,,2021-09-09,2018-03-23,2018-03-27,ACTUAL,2021-09-09,2021-10-07,ACTUAL,,,,2021-09-09,2021-10-07,ACTUAL,2018-03-08,ACTUAL,2018-03-08,2021-09,2021-09-30,2021-05-03,ACTUAL,2021-05-03,2021-05-03,ACTUAL,2021-05-03,,INTERVENTIONAL,,,Antibiotics During Intrauterine Balloon Tamponade Placement,Antibiotics During Intrauterine Balloon Tamponade Placement,TERMINATED,,PHASE4,11.0,ACTUAL,Cedars-Sinai Medical Center,,2.0,,Problems with recruitment,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,OTHER,,,,,,,2021,0.0
NCT01311518,,2011-03-07,,,2021-09-15,2011-03-08,2011-03-09,ESTIMATED,,,,,,,2021-09-15,2021-09-22,ACTUAL,2019-07,ESTIMATED,2019-07-31,2021-09,2021-09-30,2020-07,ESTIMATED,2020-07-31,2020-07,ESTIMATED,2020-07-31,,INTERVENTIONAL,,,A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Myocardial Infarction,"A Randomized, Double-blind, Placebo-Controlled, Study of the Safety and Efficacy of RGN-352 in Subjects With an Acute ST Elevation Myocardial Infarction (STEMI) After Occlusion of the Proximal Left Anterior Descending Coronary Artery",WITHDRAWN,,PHASE2,0.0,ACTUAL,"RegeneRx Biopharmaceuticals, Inc.",,2.0,,Trial never initiated,f,,,,f,t,f,,,,,,,,,,,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,INDUSTRY,,,,,,,2020,0.0
NCT04391894,,2020-05-13,2022-05-03,,2023-01-27,2020-05-13,2020-05-18,ACTUAL,2022-05-03,2022-05-26,ACTUAL,,,,2023-01-27,2023-01-30,ACTUAL,2020-10-06,ACTUAL,2020-10-06,2023-01,2023-01-31,2021-05-13,ACTUAL,2021-05-13,2021-05-13,ACTUAL,2021-05-13,,INTERVENTIONAL,,,A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease,"A Randomized, Double-masked, Multicenter Study to Evaluate the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease",COMPLETED,,PHASE2,558.0,ACTUAL,Novartis,,5.0,,,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,INDUSTRY,,,,,,,2021,1.0
NCT04311515,,2020-03-12,,,2022-11-14,2020-03-13,2020-03-17,ACTUAL,,,,,,,2022-11-14,2022-11-17,ACTUAL,2020-06-30,ACTUAL,2020-06-30,2022-11,2022-11-30,2022-11-15,ACTUAL,2022-11-15,2020-09-09,ACTUAL,2020-09-09,,INTERVENTIONAL,,,"To Evaluate Safety, Tolerability and Pharmacological Effects of PU AD in Subjects With Mild AD Dementia","A Phase 2A Study to Evaluate Safety, Tolerability and Pharmacological Effects of PU AD in Subjects With Mild Alzheimer's Disease (AD) Dementia",TERMINATED,,PHASE2,4.0,ACTUAL,"Samus Therapeutics, Inc.",,2.0,,Samus Therapeutics company closure,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,INDUSTRY,,,,,,,2022,0.0
NCT03287960,,2017-09-14,2023-04-11,,2023-05-18,2017-09-15,2017-09-19,ACTUAL,2023-05-18,2023-05-23,ACTUAL,,,,2023-05-18,2023-05-23,ACTUAL,2018-01-30,ACTUAL,2018-01-30,2023-05,2023-05-31,2020-09-25,ACTUAL,2020-09-25,2020-09-25,ACTUAL,2020-09-25,,INTERVENTIONAL,,,Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity,"An Open Label, 1-Year Trial, Including a Double-Blind Placebo-Controlled Withdrawal Period, of Setmelanotide (RM-493), a Melanocortin 4 Receptor (MC4R) Agonist, in Leptin Receptor (LEPR) Deficiency Obesity Due to Bi-Allelic Loss-of-Function LEPR Genetic Mutation",COMPLETED,,PHASE3,15.0,ACTUAL,"Rhythm Pharmaceuticals, Inc.","Based on meetings with the Federal Drug Administration (FDA), the structure of the endpoints was slightly different in the statistical analysis plan (SAP) and the protocol.~In addition, there was no planned comparison to a randomized placebo group given the rarity of monogenic LEPR deficiency obesity.",1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,INDUSTRY,,,,,,,2020,1.0
NCT05181865,,2021-12-17,,,2022-01-31,2022-01-05,2022-01-06,ACTUAL,,,,,,,2022-01-31,2022-02-07,ACTUAL,2022-01,ESTIMATED,2022-01-31,2022-01,2022-01-31,2022-01-18,ACTUAL,2022-01-18,2022-01-18,ACTUAL,2022-01-18,,INTERVENTIONAL,,,Phase 1/2a Study to Evaluate FL-301 in Patients With Advanced Solid Tumors,"A Phase 1/2a, First-In-Human, Open Label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FL-301 in Patients With Advanced Solid Tumors",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Flame Biosciences,,8.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,INDUSTRY,,,,,,,2022,0.0
NCT03266159,,2017-08-25,,,2017-12-07,2017-08-25,2017-08-30,ACTUAL,,,,,,,2017-12-07,2017-12-08,ACTUAL,2017-11-27,ESTIMATED,2017-11-27,2017-12,2017-12-31,2020-08-19,ESTIMATED,2020-08-19,2020-08-19,ESTIMATED,2020-08-19,,INTERVENTIONAL,,,"A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Clinical Activity of GSK525762 Plus Trametinib in Subjects With Solid Tumors","A Phase I/II Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 Plus Trametinib in Subjects With Small Cell Lung Cancer and Ras-Mutated Solid Tumors",WITHDRAWN,,PHASE2,0.0,ACTUAL,GlaxoSmithKline,,6.0,,Study withdrawn before active to fully evaluate impact of changing practice in target population.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,INDUSTRY,,,,,,,2020,0.0
NCT02587572,,2015-10-23,,,2023-02-14,2015-10-23,2015-10-27,ESTIMATED,,,,,,,2023-02-14,2023-02-16,ACTUAL,2023-12-01,ESTIMATED,2023-12-01,2023-02,2023-02-28,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,SIRONA,,Safety and Efficacy Trial Using Allogeneic Human Mesenchymal Stem Cells: The SIRONA Trial,"A Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety and Efficacy of Allogeneic Human Mesenchymal Stem Cells in Patients With Metabolic Syndrome.",WITHDRAWN,,PHASE2,0.0,ACTUAL,Longeveron Inc.,,4.0,,Sponsor has made decision not to conduct this clinical trial.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,INDUSTRY,,,,,,,2023,0.0
NCT04875533,,2021-05-03,2023-05-10,,2023-11-05,2021-05-03,2021-05-06,ACTUAL,2023-11-05,2023-11-28,ACTUAL,,,,2023-11-05,2023-11-28,ACTUAL,2021-06-14,ACTUAL,2021-06-14,2023-11,2023-11-30,2022-05-13,ACTUAL,2022-05-13,2022-05-13,ACTUAL,2022-05-13,,INTERVENTIONAL,,"All participants who receive at least 1 dose of the study intervention (20vPnC, 13vPnC, PPSV23 or saline).","20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan","A PHASE 3, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY-UNBLINDED TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 60 YEARS OF AGE AND OLDER IN JAPAN, KOREA, AND TAIWAN",COMPLETED,,PHASE3,1425.0,ACTUAL,Pfizer,,2.0,,,f,,,,f,t,f,,,t,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,INDUSTRY,,,,,,,2022,1.0
NCT02518191,,2015-08-05,2021-03-12,,2021-05-14,2015-08-05,2015-08-07,ESTIMATED,2021-04-07,2021-05-03,ACTUAL,,,,2021-05-14,2021-06-11,ACTUAL,2015-09-01,ACTUAL,2015-09-01,2021-05,2021-05-31,2021-01-12,ACTUAL,2021-01-12,2021-01-12,ACTUAL,2021-01-12,,INTERVENTIONAL,,,Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity,Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity in Women With Breast Cancer in China,COMPLETED,,PHASE3,345.0,ACTUAL,Shanghai Jiao Tong University Affiliated Sixth People's Hospital,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,OTHER,,,,,,,2021,1.0
NCT02408016,,2015-03-31,2021-06-30,,2021-08-16,2015-03-31,2015-04-03,ESTIMATED,2021-08-16,2021-09-13,ACTUAL,,,,2021-08-16,2021-09-13,ACTUAL,2015-05-22,ACTUAL,2015-05-22,2021-08,2021-08-31,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,No patients were treated in Arm II,Genetically Modified T Cells in Treating Patients With Stage III-IV Non-small Cell Lung Cancer or Mesothelioma,"Phase I/II Study in WT1-Expressing Non-small Cell Lung Cancer and Mesothelioma, Comparing Cellular Adoptive Immunotherapy With Polyclonal Autologous Central Memory to Naïve CD8+ T Cells That Have Been Transduced to Express a WT1-Specific T-Cell Receptor",TERMINATED,,PHASE1/PHASE2,11.0,ACTUAL,Fred Hutchinson Cancer Center,,3.0,,Terminated due to loss of funding,f,,,,t,t,f,,,,,,,,,,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,OTHER,,,,,,,2020,0.0
NCT01844505,,2013-04-29,2017-07-14,,2024-06-20,2013-04-30,2013-05-01,ESTIMATED,2017-08-28,2017-09-26,ACTUAL,,,,2024-06-20,2024-07-03,ACTUAL,2013-06-11,ACTUAL,2013-06-11,2024-06,2024-06-30,2024-04-19,ACTUAL,2024-04-19,2016-08-01,ACTUAL,2016-08-01,,INTERVENTIONAL,,All randomized participants,Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067),"A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma",COMPLETED,,PHASE3,1296.0,ACTUAL,Bristol-Myers Squibb,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,INDUSTRY,,,,,,,2024,1.0
NCT05760781,,2023-02-23,,,2023-12-13,2023-03-06,2023-03-08,ACTUAL,,,,,,,2023-12-13,2023-12-19,ACTUAL,2023-04-25,ACTUAL,2023-04-25,2023-12,2023-12-31,2023-12-11,ACTUAL,2023-12-11,2023-12-11,ACTUAL,2023-12-11,,INTERVENTIONAL,,,To Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B,"Phase Ib/II: Multicenter, Open, Dose-escalation Evaluation of the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B Treated With Oral Antiviral Therapy",TERMINATED,,PHASE2,9.0,ACTUAL,"Staidson (Beijing) Biopharmaceuticals Co., Ltd",,4.0,,"The preliminary effectiveness data observed at present did not meet the expectations, the benefit of the subjects receiving the experimental drug was limited.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,INDUSTRY,,,,,,,2023,0.0
NCT04661917,,2020-11-20,,,2021-05-19,2020-12-08,2020-12-10,ACTUAL,,,,,,,2021-05-19,2021-05-21,ACTUAL,2021-05-31,ESTIMATED,2021-05-31,2021-05,2021-05-31,2022-05-19,ESTIMATED,2022-05-19,2022-04-25,ESTIMATED,2022-04-25,,INTERVENTIONAL,ASSESS-CKD,,"A Trial to Learn More About How BAY2327949 Works and How Safe it is in Patients Whose Kidneys Are Damaged Due to High Blood Sugar Levels or High Blood Pressures, and With a Further Disease of the Heart or the Blood Vessels.","A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of BAY 2327949 in Patients With Chronic Kidney Disease (eGFR Range From 25 to 60 mL/Min/1.73 m²) Due to Type 2 Diabetes or Hypertension and at Least One Cardiovascular Comorbidity",WITHDRAWN,,PHASE2,0.0,ACTUAL,Bayer,,2.0,,Study withdrawn due to company decision,f,,,,f,f,f,,,,,,,,,UNDECIDED,"Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,INDUSTRY,,,,,,,2022,0.0
NCT03485976,,2018-03-20,2020-05-29,,2020-06-15,2018-03-26,2018-04-03,ACTUAL,2020-06-15,2020-07-01,ACTUAL,,,,2020-06-15,2020-07-01,ACTUAL,2018-05-23,ACTUAL,2018-05-23,2020-06,2020-06-30,2020-01-13,ACTUAL,2020-01-13,2019-10-14,ACTUAL,2019-10-14,,INTERVENTIONAL,,All enrolled patients at baseline,Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP),Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP),COMPLETED,,PHASE2,12.0,ACTUAL,Oregon Health and Science University,,1.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,OTHER,,,,,,,2020,1.0
NCT03434353,,2018-02-09,2022-03-08,2020-10-14,2022-03-08,2018-02-09,2018-02-15,ACTUAL,2022-03-08,2022-04-04,ACTUAL,2020-10-14,2020-10-20,ACTUAL,2022-03-08,2022-04-04,ACTUAL,2018-02-28,ACTUAL,2018-02-28,2022-03,2022-03-31,2021-01-26,ACTUAL,2021-01-26,2020-01-20,ACTUAL,2020-01-20,,INTERVENTIONAL,,The Safety Analysis Set included all participants who took at least 1 dose of any study drug.,Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB),"A Phase 2, Randomized, Open-Label, Active-Controlled Study to Evaluate the Safety and Antiviral Activity of GS-9992 Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Chronic Hepatitis B (CHB) Subjects",TERMINATED,,PHASE2,123.0,ACTUAL,Gilead Sciences,,5.0,,Study was terminated due to sponsor's decision to not pursue further development of inarigivir soproxil in chronic hepatitis B.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,INDUSTRY,,,,,,,2021,0.0
NCT04327505,,2020-03-25,,,2023-01-05,2020-03-27,2020-03-31,ACTUAL,,,,,,,2023-01-05,2023-01-09,ACTUAL,2020-06-03,ACTUAL,2020-06-03,2023-01,2023-01-31,2022-12-01,ACTUAL,2022-12-01,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,COVID-19-HBO,,Safety and Efficacy of Hyperbaric Oxygen for ARDS in Patients With COVID-19,"A Randomized, Controlled, Open Label, Multicentre Clinical Trial to Explore Safety and Efficacy of Hyperbaric Oxygen for Preventing ICU Admission, Morbidity and Mortality in Adult Patients With COVID-19",TERMINATED,,PHASE2/PHASE3,34.0,ACTUAL,Karolinska Institutet,,2.0,,"Futility, change of disease due to virus mutations and/or vaccination",f,,,,t,f,f,,,f,,,Starting after publication and for 36 months,A full description of the intended use of the data must be sent to the corresponding author for review and approval. Participant consent for data sharing is conditioned and new ethics approval may be required.,,YES,"The full study protocol, statistical plan and consent form will be publicly available when results are published. Data will be available on patient level; data will be pseudonymized. The full dataset and statistical code will be available upon request.",2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,OTHER,,,,,,,2022,0.0
NCT03926156,,2019-04-22,,,2021-08-14,2019-04-22,2019-04-24,ACTUAL,,,,,,,2021-08-14,2021-08-19,ACTUAL,2019-05-22,ACTUAL,2019-05-22,2021-08,2021-08-31,2021-08-14,ACTUAL,2021-08-14,2021-05-22,ACTUAL,2021-05-22,,INTERVENTIONAL,RISE MS,,RIvoraxaban in Mitral Stenosis,RIvoraxaban Safety and Efficacy in Patients With Mitral Stenosis,TERMINATED,,PHASE3,40.0,ACTUAL,Rajaie Cardiovascular Medical and Research Center,,2.0,,COVID-19 has impacted our study recruitment,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,OTHER,,,,,,,2021,0.0
NCT03812562,,2019-01-16,,,2024-02-19,2019-01-17,2019-01-23,ACTUAL,,,,,,,2024-02-19,2024-02-21,ACTUAL,2019-02-07,ACTUAL,2019-02-07,2024-02,2024-02-29,2023-10-19,ACTUAL,2023-10-19,2023-10-19,ACTUAL,2023-10-19,,INTERVENTIONAL,,,Nivolumab and Yttrium-90 in Treating Patients With Liver Cancer Undergoing Surgical Resection,Pilot Study of Nivolumab in Combination With Therasphere (Yttrium-90) for Treatment of Hepatocellular Carcinoma (HCC) With Intent for Resection,TERMINATED,,EARLY_PHASE1,2.0,ACTUAL,Northwestern University,,1.0,,Lack of funding,,,,,t,t,f,,,f,,,,,,,,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,OTHER,,,,,,,2023,0.0
NCT02318082,,2014-12-12,,,2020-06-22,2014-12-16,2014-12-17,ESTIMATED,,,,,,,2020-06-22,2020-06-23,ACTUAL,2015-02,,2015-02-28,2020-06,2020-06-30,2020-04-22,ACTUAL,2020-04-22,2017-10,ACTUAL,2017-10-31,,INTERVENTIONAL,,,Study of Individual Adult and Pediatric Patient Dose-escalated Interleukin-2 Therapy for Refractory Chronic GVHD,A Phase I Study of Individual Adult and Pediatric Patient Dose-escalated Interleukin-2 Therapy for Refractory Chronic Graft-versus-Host-Disease,COMPLETED,,PHASE1,21.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,OTHER,,,,,,,2020,1.0
NCT04643158,,2020-11-23,,,2023-08-14,2020-11-23,2020-11-24,ACTUAL,,,,,,,2023-08-14,2023-08-16,ACTUAL,2021-03-12,ACTUAL,2021-03-12,2023-08,2023-08-31,2023-07-20,ACTUAL,2023-07-20,2023-07-20,ACTUAL,2023-07-20,,INTERVENTIONAL,APATURA,,Efficacy and Safety of Inhaled AZD1402 Administered for Four Weeks in Adults With Asthma on Medium-to-High Dose Inhaled Corticosteroids,"A Two-part Phase IIa Randomised, Double-blind, Placebo-controlled, Dose-ranging, Multi-centre Study to Assess Efficacy and Safety of Inhaled AZD1402 Administered as a Dry Powder for Four Weeks in Adults With Asthma on Medium-to-High Dose Inhaled Corticosteroids",TERMINATED,,PHASE2,72.0,ACTUAL,AstraZeneca,,4.0,,"The decision was based on lung findings from a non-clinical 13-week Good Laboratory Practice (GLP) toxicology study, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development.",f,,,,t,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in a sponsor approved tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,INDUSTRY,,,,,,,2023,0.0
NCT05293236,,2022-03-18,,,2023-08-04,2022-03-23,2022-03-24,ACTUAL,,,,,,,2023-08-04,2023-08-07,ACTUAL,2022-01-14,ACTUAL,2022-01-14,2023-08,2023-08-31,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,ApTOLL for the Treatment of COVID-19,"A Double Blind, Placebo-Controlled, Randomized, Phase Ib Clinical Study of ApTOLL for the Treatment of COVID-19",TERMINATED,,PHASE1,5.0,ACTUAL,aptaTargets S.L.,,4.0,,Lack of patients due to reduced incidence in the COVID-19 infected population in Spain,f,,,,,f,f,,,,,,,,,UNDECIDED,We have not planned this point yet,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,INDUSTRY,,,,,,,2022,0.0
NCT04335552,,2020-04-03,2021-05-03,,2021-05-13,2020-04-03,2020-04-06,ACTUAL,2021-05-03,2021-05-12,ACTUAL,,,,2021-05-13,2021-05-17,ACTUAL,2020-04-17,ACTUAL,2020-04-17,2021-05,2021-05-31,2020-06-26,ACTUAL,2020-06-26,2020-06-17,ACTUAL,2020-06-17,,INTERVENTIONAL,,,"Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection","Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection",TERMINATED,,PHASE2,11.0,ACTUAL,Duke University,,4.0,,"Poor recruitment, strong evidence from larger trials of no therapeutic benefit",f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,OTHER,,,,,,,2020,0.0
NCT03196401,,2017-06-21,,,2018-08-02,2017-06-21,2017-06-22,ACTUAL,,,,,,,2018-08-02,2018-08-03,ACTUAL,2017-07-27,ACTUAL,2017-07-27,2018-08,2018-08-31,2020-06,ESTIMATED,2020-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,A Study of Durvalumab (Anti-PDL1) Plus Radiation Therapy for the Treatment of Solitary Bone Plasmacytoma,A Pilot Study to Evaluate for the Abscopal Effect of Durvalumab (Anti-PD-L1) in Combination With Definitive Radiation Therapy in Solitary Bone Plasmacytoma With Limited Clonal Bone Marrow Plasmacytosis,WITHDRAWN,,PHASE1,0.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,FDA recommendation,f,,,,,t,f,,,,,,,,,,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,OTHER,,,,,,,2020,0.0
NCT04000594,,2019-06-26,2023-01-13,,2024-06-18,2019-06-26,2019-06-27,ACTUAL,2024-06-18,2024-10-03,ACTUAL,,,,2024-06-18,2024-10-03,ACTUAL,2019-09-02,ACTUAL,2019-09-02,2024-06,2024-06-30,2022-01-18,ACTUAL,2022-01-18,2022-01-18,ACTUAL,2022-01-18,,INTERVENTIONAL,,,"A Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 (RG6042) in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's Disease","An Open-Label Adaptive Multiple-Dose Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's Disease",COMPLETED,,PHASE1,12.0,ACTUAL,Hoffmann-La Roche,,3.0,,,f,,,,,f,f,,,,,,,,,NO,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,INDUSTRY,,,,,,,2022,1.0
NCT05414734,,2022-05-27,,,2023-01-30,2022-06-07,2022-06-10,ACTUAL,,,,,,,2023-01-30,2023-02-01,ACTUAL,2022-07-01,ESTIMATED,2022-07-01,2023-01,2023-01-31,2023-03-01,ESTIMATED,2023-03-01,2023-02-15,ESTIMATED,2023-02-15,,INTERVENTIONAL,HHT120,,"Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Characteristics of HHT120 in Healthy Subjects","A Single and Multiple Assending Doses Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Characteristics and Food Effect After Administration of HHT120 Capsule in Healthy Subjects",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Zhejiang Huahai Pharmaceutical Co., Ltd.",,6.0,,Commercialization consideration. Without safety issues.,f,,,,f,f,f,,,,,,,,,,,2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,INDUSTRY,,,,,,,2023,0.0
NCT02980003,,2016-11-05,,,2022-05-19,2016-11-29,2016-12-02,ESTIMATED,,,,,,,2022-05-19,2022-05-23,ACTUAL,2015-03,,2015-03-31,2022-05,2022-05-31,2021-05-01,ACTUAL,2021-05-01,2020-10-30,ACTUAL,2020-10-30,,INTERVENTIONAL,TEATE,,PrevenTion of Contrast-inducEd nephroAThy With urinE Alkalinization,PrevenTion of Contrast-inducEd nephroAThy With urinE Alkalinization: the TEATE Study,COMPLETED,,PHASE3,240.0,ACTUAL,G. d'Annunzio University,,3.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,OTHER,,,,,,,2021,0.0
NCT04192513,,2019-12-02,,,2021-06-16,2019-12-06,2019-12-10,ACTUAL,,,,,,,2021-06-16,2021-06-18,ACTUAL,2019-05-20,ACTUAL,2019-05-20,2020-07,2020-07-31,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,"Observer-Blinded Dose Escalating, Single Dose to Study Safety and Antimicrobial Efficacy of Gel vs. Placebo","A Randomized, Observer-Blinded, Vehicle Controlled, Single Dose, Dose Escalating, Single Application Within-patient Bilateral Comparison to Study the Safety and Antimicrobial Efficacy of DBI-001 Gel Vs. Placebo",TERMINATED,,PHASE2,9.0,ACTUAL,"DermBiont, Inc.",,3.0,,Covid-19 has shut the clinic indefinitely,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,INDUSTRY,,,,,,,2020,0.0
NCT04304781,,2020-02-19,,,2022-11-17,2020-03-10,2020-03-11,ACTUAL,,,,,,,2022-11-17,2022-11-22,ACTUAL,2020-09-22,ACTUAL,2020-09-22,2022-11,2022-11-30,2021-12-17,ACTUAL,2021-12-17,2021-12-17,ACTUAL,2021-12-17,,INTERVENTIONAL,,,Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer,Phase 1 In-vivo Study of KSP/QRH Heptapeptide Dimer for Detection of Biliary Intra-epithelial Neoplasia,TERMINATED,,PHASE1,12.0,ACTUAL,University of Michigan,,1.0,,Terminated due to lack of dimer.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,OTHER,,,,,,,2021,0.0
NCT05116046,,2021-10-18,2023-12-11,,2024-02-06,2021-11-03,2021-11-10,ACTUAL,2024-02-06,2024-02-08,ACTUAL,,,,2024-02-06,2024-02-08,ACTUAL,2021-12-24,ACTUAL,2021-12-24,2024-02,2024-02-29,2023-03-30,ACTUAL,2023-03-30,2022-12-16,ACTUAL,2022-12-16,,INTERVENTIONAL,,Full Analysis Set (FAS) included all participants who received at least 1 dose of recifercept. Participants were analyzed according to the dose they actually received.,"Continuation Study of Long-term Safety, Tolerability, Pharmacokinetics and Efficacy of Recifercept in Achondroplasia","A PHASE 2 OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA",TERMINATED,,PHASE2,35.0,ACTUAL,Pfizer,Data was not collected for efficacy endpoints as study was terminated early based on sponsor discretion due to lack of efficacy at any of the tested doses. The decision to terminate the study was not related to a safety concern.,3.0,,The study was terminated due to lack of efficacy at any of the tested doses on 18th November 2022. The decision to terminate the study is not related to a safety concern.,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,INDUSTRY,,,,,,,2023,0.0
NCT03190304,,2017-06-14,,,2020-10-21,2017-06-14,2017-06-16,ACTUAL,,,,,,,2020-10-21,2020-10-22,ACTUAL,2017-06-14,ACTUAL,2017-06-14,2020-03,2020-03-31,2020-09-23,ACTUAL,2020-09-23,2020-09-14,ACTUAL,2020-09-14,,INTERVENTIONAL,NEPRIExTol,,The Effect of Neprilysin (LCZ696) on Exercise Tolerance in Patients With Heart Failure,"The Effect of NEPRIlysin (LCZ696) on EXercise TOLerance, Muscle Vasodilatation, Muscle Strength and Body Composition in Patients With Heart Failure - NEPRIExTol-HF Trial",COMPLETED,,PHASE4,52.0,ACTUAL,University of Sao Paulo General Hospital,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,OTHER,,,,,,,2020,0.0
NCT05214196,,2022-01-25,,,2022-01-28,2022-01-25,2022-01-28,ACTUAL,,,,,,,2022-01-28,2022-02-11,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2022-01,2022-01-31,2021-12-07,ACTUAL,2021-12-07,2021-12-01,ACTUAL,2021-12-01,,INTERVENTIONAL,,,The Efficacy of Oral Antiseptics Against COVID-19,The Effectiveness of Oral Antiseptics on the Intraoral Viral Load of SARS-CoV-2,COMPLETED,,PHASE4,75.0,ACTUAL,Ataturk University,,3.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,OTHER,,,,,,,2021,0.0
NCT03323866,,2017-10-24,,,2022-09-16,2017-10-24,2017-10-27,ACTUAL,,,,,,,2022-09-16,2022-09-21,ACTUAL,2017-05-01,ACTUAL,2017-05-01,2022-09,2022-09-30,2022-08-01,ACTUAL,2022-08-01,2022-05-01,ACTUAL,2022-05-01,,INTERVENTIONAL,,,Mometasone vs Budesonide in CRS With Polyposis,Randomized Controled Double-blinded Study Comparing Mometasone Nasal Spray to Budesonide Irrigations in Patients With Chronic Rhinosinusitis With Nasal Polyposis,TERMINATED,,PHASE3,36.0,ACTUAL,Université de Sherbrooke,,2.0,,Difficulty with recruitment,f,,,,f,f,f,,,f,,,,,,,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,OTHER,,,,,,,2022,0.0
NCT01920061,,2013-08-07,2021-01-06,,2022-08-20,2013-08-07,2013-08-09,ESTIMATED,2021-09-09,2021-10-07,ACTUAL,,,,2022-08-20,2022-09-13,ACTUAL,2013-09-10,ACTUAL,2013-09-10,2022-08,2022-08-31,2020-01-08,ACTUAL,2020-01-08,2020-01-08,ACTUAL,2020-01-08,,INTERVENTIONAL,,All enrolled participants who received at least one dose of study medication.,A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC),A PHASE 1B OPEN-LABEL THREE-ARM MULTI-CENTER STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF PF-05212384 (PI3K/MTOR INHIBITOR) IN COMBINATION WITH OTHER ANTI-TUMOR AGENTS,COMPLETED,,PHASE1,110.0,ACTUAL,Pfizer,,5.0,,,f,,,,f,,,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 11:16:27.059592,2024-10-16 11:16:27.059592,INDUSTRY,,,,,,,2020,1.0
NCT03761069,,2018-11-29,,,2022-01-18,2018-11-29,2018-12-03,ACTUAL,,,,,,,2022-01-18,2022-02-02,ACTUAL,2018-10-29,ACTUAL,2018-10-29,2022-01,2022-01-31,2021-12-28,ACTUAL,2021-12-28,2021-12-28,ACTUAL,2021-12-28,,INTERVENTIONAL,,,Study of PTC299 (Emvododstat) in Relapsed/Refractory Acute Leukemias,Phase 1B Study of PTC299 in Relapsed/Refractory Acute Leukemias,TERMINATED,,PHASE1,33.0,ACTUAL,PTC Therapeutics,,1.0,,Sponsor terminated the study.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,INDUSTRY,,,,,,,2021,0.0
NCT04167137,,2019-11-12,2022-10-27,,2023-11-22,2019-11-15,2019-11-18,ACTUAL,2023-11-22,2024-05-03,ACTUAL,,,,2023-11-22,2024-05-03,ACTUAL,2019-12-12,ACTUAL,2019-12-12,2023-11,2023-11-30,2021-12-09,ACTUAL,2021-12-09,2021-12-09,ACTUAL,2021-12-09,,INTERVENTIONAL,,"All participants who were enrolled, allocated to treatment, and received at least 1 dose of investigational product.",Safety and Tolerability of SYNB1891 Injection Alone or in Combination With Atezolizumab in Adult Participants,"A Phase 1, Open-label, Multicenter Study of SYNB1891 Administered by Intratumoral Injection to Patients With Advanced/Metastatic Solid Tumors and Lymphoma Alone and in Combination With Atezolizumab",TERMINATED,,PHASE1,32.0,ACTUAL,Synlogic,The study was terminated prematurely by the Sponsor prior to enrollment completion.,2.0,,Business reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,INDUSTRY,,,,,,,2021,0.0
NCT01231516,,2010-10-21,2013-08-15,,2022-03-14,2010-10-28,2010-11-01,ESTIMATED,2013-12-12,2014-01-31,ESTIMATED,,,,2022-03-14,2022-03-15,ACTUAL,2010-10-26,ACTUAL,2010-10-26,2022-03,2022-03-31,2021-02-02,ACTUAL,2021-02-02,2013-02-04,ACTUAL,2013-02-04,,INTERVENTIONAL,SAILING,Four participants from one closed site were removed from the ITT-E Population creating the modified ITT-E Population with 715 participants.,"A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults","A Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered With an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral-Experienced Adults",COMPLETED,,PHASE3,724.0,ACTUAL,ViiV Healthcare,,2.0,,,f,,,,f,,,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,INDUSTRY,,,,,,,2021,1.0
NCT00911339,,2009-05-29,,,2021-08-30,2009-05-29,2009-06-01,ESTIMATED,,,,,,,2021-08-30,2021-08-31,ACTUAL,2009-01,ACTUAL,2009-01-31,2021-08,2021-08-31,2021-05-13,ACTUAL,2021-05-13,2021-05-13,ACTUAL,2021-05-13,,INTERVENTIONAL,,,Mobilization of Endothelial Progenitor Cells Induced by Atorvastatin in Patients With Stable Coronary Artery Disease Treated With Anti-CD 34 Antibodies Coated Stents,Mobilization of Endothelial Progenitor Cells Induced by Atorvastatin in Patients With Stable Coronary Artery Disease Treated With Anti-CD 34 Antibodies Coated Stents,TERMINATED,,PHASE3,13.0,ACTUAL,Fondazione IRCCS Policlinico San Matteo di Pavia,,2.0,,prematurely interrupted because of difficulty in enrolment of patients.,f,,,,f,,,,,,,,,,,,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,OTHER,,,,,,,2021,0.0
NCT02374021,,2015-02-11,2022-07-26,,2022-10-25,2015-02-23,2015-02-27,ESTIMATED,2022-10-25,2022-10-26,ACTUAL,,,,2022-10-25,2022-10-26,ACTUAL,2016-07,,2016-07-31,2022-10,2022-10-31,2021-05,ACTUAL,2021-05-31,2021-05,ACTUAL,2021-05-31,,INTERVENTIONAL,TARGET,Baseline Patient Characteristics of Patients Included in Final Analyses,Treatments Against RA and Effect on FDG-PET/CT,Treatments Against RA and Effect on FDG-PET/CT (The TARGET Trial),COMPLETED,,PHASE4,159.0,ACTUAL,Brigham and Women's Hospital,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,OTHER,,,,,,,2021,1.0
NCT04780464,,2021-03-02,,,2024-02-21,2021-03-02,2021-03-03,ACTUAL,,,,,,,2024-02-21,2024-02-22,ACTUAL,2022-04-11,ACTUAL,2022-04-11,2024-02,2024-02-29,2023-11-11,ACTUAL,2023-11-11,2023-09-22,ACTUAL,2023-09-22,,INTERVENTIONAL,Tolerance,,A 3 Arm Randomized Study on Health-related QoL of Elderly Patients With Advanced Soft Tissue Sarcoma,a 3 Arm Randomized Study on Health-related Quality of Life of Elderly Patients With Advanced Soft Tissue Sarcoma Undergoing Doxorubicin Alone Every Three Weeks or Doxorubicin Weekly or Cyclophosphamide Plus Predniso(lo)ne Treatment,TERMINATED,,PHASE3,14.0,ACTUAL,European Organisation for Research and Treatment of Cancer - EORTC,,3.0,,Withdrawal grant provider,f,,,,t,f,f,,,,,,,,,,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,NETWORK,,,,,,,2023,0.0
NCT02540993,,2015-09-02,2021-04-05,,2023-07-20,2015-09-02,2015-09-04,ESTIMATED,2021-06-29,2021-07-19,ACTUAL,,,,2023-07-20,2023-07-24,ACTUAL,2015-09-17,ACTUAL,2015-09-17,2023-07,2023-07-31,2020-04-14,ACTUAL,2020-04-14,2020-04-14,ACTUAL,2020-04-14,,INTERVENTIONAL,FIDELIO-DKD,Full analysis set (FAS): the FAS comprised all randomized participants (except those with critical GCP violations),Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease,"A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease",COMPLETED,,PHASE3,5734.0,ACTUAL,Bayer,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,INDUSTRY,,,,,,,2020,1.0
NCT02945813,,2016-10-25,,,2022-04-07,2016-10-25,2016-10-26,ESTIMATED,,,,,,,2022-04-07,2022-04-14,ACTUAL,2017-10-24,ACTUAL,2017-10-24,2022-04,2022-04-30,2022-02-28,ACTUAL,2022-02-28,2022-02-28,ACTUAL,2022-02-28,,INTERVENTIONAL,,,SAKK 08/15 - PROMET - Salvage Radiotherapy +/- Metformin for Patients With Prostate Cancer After Prostatectomy,"SAKK 08/15 - PROMET - Multicenter, Randomized Phase II Trial of Salvage Radiotherapy +/- Metformin for Patients With Prostate Cancer After Prostatectomy",TERMINATED,,PHASE2,112.0,ACTUAL,Swiss Group for Clinical Cancer Research,,2.0,,Trial was prematurely closed for accrual by the SAKK Board and the follow-up period shortened to one year after last RT fraction of the last patient,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,OTHER,,,,,,,2022,0.0
NCT03292146,,2017-09-21,2022-07-20,,2022-09-19,2017-09-21,2017-09-25,ACTUAL,2022-09-19,2022-10-12,ACTUAL,,,,2022-09-19,2022-10-12,ACTUAL,2017-10-25,ACTUAL,2017-10-25,2022-09,2022-09-30,2021-07-22,ACTUAL,2021-07-22,2021-07-22,ACTUAL,2021-07-22,,INTERVENTIONAL,,"Women, age 20-60 years, with anorexia nervosa or atypical anorexia nervosa and BMD T-score \< -1.0",Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study,"Effects of Denosumab on Bone Mineral Density, Markers of Bone Metabolism and Bone Microarchitecture in Women With Anorexia Nervosa: A Pilot Study",COMPLETED,,PHASE3,30.0,ACTUAL,Massachusetts General Hospital,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,OTHER,,,,,,,2021,1.0
NCT03600623,,2018-07-17,,,2020-08-14,2018-07-17,2018-07-26,ACTUAL,,,,,,,2020-08-14,2020-08-18,ACTUAL,2017-09-25,ACTUAL,2017-09-25,2020-08,2020-08-31,2020-07-31,ACTUAL,2020-07-31,2020-07-30,ACTUAL,2020-07-30,,INTERVENTIONAL,,,Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer,Neoadjuvant Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy (SBRT) for Patients With Locally Advanced Pancreatic Cancer,TERMINATED,,EARLY_PHASE1,25.0,ACTUAL,University of Alabama at Birmingham,,2.0,,PI left the institution; no further accruals,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,OTHER,,,,,,,2020,0.0
NCT03595618,,2018-07-11,2021-04-20,,2021-07-27,2018-07-20,2018-07-23,ACTUAL,2021-04-20,2021-05-12,ACTUAL,,,,2021-07-27,2021-07-28,ACTUAL,2018-08-14,ACTUAL,2018-08-14,2021-07,2021-07-31,2020-07-14,ACTUAL,2020-07-14,2020-07-14,ACTUAL,2020-07-14,,INTERVENTIONAL,Roccella,Modified Randomised Set (mRS): All included participants to whom a therapeutic unit was randomly assigned using the interactive web response system.,A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis,"Efficacy and Safety of 3 Doses of S201086/GLPG1972 Administered Orally Once Daily in Patients With Knee Osteoarthritis. A 52-week International, Multi-regional, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study",COMPLETED,,PHASE2,932.0,ACTUAL,Galapagos NV,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,INDUSTRY,,,,,,,2020,1.0
NCT02798471,,2016-05-11,2022-11-16,,2023-02-03,2016-06-08,2016-06-14,ESTIMATED,2023-02-03,2023-03-06,ACTUAL,,,,2023-02-03,2023-03-06,ACTUAL,2017-03-27,ACTUAL,2017-03-27,2023-02,2023-02-28,2022-05-24,ACTUAL,2022-05-24,2022-05-24,ACTUAL,2022-05-24,,INTERVENTIONAL,,Baseline demographic characteristics were reported in the Randomized Analysis Set.,Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE),"A Phase 3, Open-label, Randomized, Multi-center, Controlled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Edoxaban and to Compare the Efficacy and Safety of Edoxaban With Standard of Care Anticoagulant Therapy in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed Venous Thromboembolism (VTE)",COMPLETED,,PHASE3,290.0,ACTUAL,Daiichi Sankyo,,2.0,,,f,,,,t,t,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,INDUSTRY,,,,,,,2022,1.0
NCT03209401,,2017-07-03,,,2024-02-01,2017-07-03,2017-07-06,ACTUAL,,,,,,,2024-02-01,2024-02-05,ACTUAL,2017-10-13,ACTUAL,2017-10-13,2024-02,2024-02-29,2023-10-16,ACTUAL,2023-10-16,2023-10-16,ACTUAL,2023-10-16,,INTERVENTIONAL,,,Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies,Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies,TERMINATED,,PHASE1,23.0,ACTUAL,Georgetown University,,1.0,,Lack of accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:06:27.097056,2024-10-15 15:06:27.097056,OTHER,,,,,,,2023,0.0
NCT04046848,,2019-07-18,,,2022-03-31,2019-08-02,2019-08-06,ACTUAL,,,,,,,2022-03-31,2022-04-08,ACTUAL,2019-07-03,ACTUAL,2019-07-03,2022-03,2022-03-31,2022-02-18,ACTUAL,2022-02-18,2022-02-18,ACTUAL,2022-02-18,,INTERVENTIONAL,,,Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A,Phase 1/2 Study to Assess the Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Previously Treated Adult Patients With Severe Hemophilia A,TERMINATED,,PHASE1/PHASE2,30.0,ACTUAL,Octapharma,,5.0,,Study was terminated due to SADRs,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,INDUSTRY,,,,,,,2022,0.0
NCT04972968,,2021-07-13,2024-07-18,,2024-10-10,2021-07-13,2021-07-22,ACTUAL,2024-10-10,2024-10-15,ACTUAL,,,,2024-10-10,2024-10-15,ACTUAL,2021-09-09,ACTUAL,2021-09-09,2024-10,2024-10-31,2023-07-24,ACTUAL,2023-07-24,2023-07-24,ACTUAL,2023-07-24,,INTERVENTIONAL,AIM-PMR,,"A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154","A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment",TERMINATED,,PHASE2,181.0,ACTUAL,AbbVie,AbbVie has decided to discontinue further subject enrollment in the M20-370 (ABBV-154) study. This decision is not based on a safety or an efficacy signal; rather this decision was made because of a change in AbbVie's development.,4.0,,Strategic considerations,f,,,,t,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,INDUSTRY,,,,,,,2023,0.0
NCT03787303,,2018-12-12,2022-03-17,,2022-05-11,2018-12-21,2018-12-26,ACTUAL,2022-05-11,2022-05-13,ACTUAL,,,,2022-05-11,2022-05-13,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2022-05,2022-05-31,2022-03-09,ACTUAL,2022-03-09,2022-03-09,ACTUAL,2022-03-09,,INTERVENTIONAL,B-TREUH,,Study of Euthyroid Hypothyroxinemia in Metastatic Breast Carcinoma,A Single Arm Phase II Pilot Study of Euthyroid Hypothyroxinemia in Metastatic Breast Carcinoma,TERMINATED,,PHASE2,7.0,ACTUAL,Aultman Health Foundation,Limitation is small sample size due to pandemic affecting clinical trial accrual. A larger sample is needed to adequately answer the research question.,1.0,,Relocation of Principal Investigator,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,OTHER,,,,,,,2022,0.0
NCT03624127,,2018-08-07,2022-10-06,2021-09-01,2023-01-09,2018-08-07,2018-08-09,ACTUAL,2023-01-09,2023-01-30,ACTUAL,2023-01-09,2023-01-30,ACTUAL,2023-01-09,2023-01-30,ACTUAL,2018-08-07,ACTUAL,2018-08-07,2023-01,2023-01-31,2020-09-02,ACTUAL,2020-09-02,2020-09-02,ACTUAL,2020-09-02,,INTERVENTIONAL,POETYK-PSO-1,,Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis,"A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis",COMPLETED,,PHASE3,666.0,ACTUAL,Bristol-Myers Squibb,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,INDUSTRY,,,,,,,2020,1.0
NCT04014361,,2019-07-09,2023-08-17,,2023-08-17,2019-07-09,2019-07-10,ACTUAL,2023-08-17,2024-03-12,ACTUAL,,,,2023-08-17,2024-03-12,ACTUAL,2019-08-09,ACTUAL,2019-08-09,2023-08,2023-08-31,2020-02-09,ACTUAL,2020-02-09,2020-02-09,ACTUAL,2020-02-09,,INTERVENTIONAL,,All randomized participants.,A Study of LY3154885 in Healthy Participants,"Single- and Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3154885 in Healthy Subjects",TERMINATED,,PHASE1,36.0,ACTUAL,Eli Lilly and Company,A strategic business decision was made to terminate the study prior to initiation of the multiple-ascending dose study (Part C). The secondary objectives pertaining to Part D were not evaluated as the study was terminated before the commencement of Part D.,7.0,,HUAA study is terminated early due to a business decision.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,INDUSTRY,,,,,,,2020,0.0
NCT04644315,,2020-11-20,2023-04-21,,2023-07-17,2020-11-20,2020-11-25,ACTUAL,2023-07-17,2023-08-07,ACTUAL,,,,2023-07-17,2023-08-07,ACTUAL,2021-05-24,ACTUAL,2021-05-24,2023-07,2023-07-31,2022-05-16,ACTUAL,2022-05-16,2022-05-16,ACTUAL,2022-05-16,,INTERVENTIONAL,ALpha-T,,A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors,"A Phase II, Open-Label, Single Arm Decentralized Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors",TERMINATED,,PHASE2,1.0,ACTUAL,Hoffmann-La Roche,,1.0,,The data from this study is no longer needed.,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,INDUSTRY,,,,,,,2022,0.0
NCT03966053,,2019-05-23,2021-11-22,,2022-11-18,2019-05-24,2019-05-29,ACTUAL,2022-11-18,2022-12-14,ACTUAL,,,,2022-11-18,2022-12-14,ACTUAL,2019-09-13,ACTUAL,2019-09-13,2022-11,2022-11-30,2021-10-13,ACTUAL,2021-10-13,2021-10-13,ACTUAL,2021-10-13,,INTERVENTIONAL,DBA,,The Use of Trifluoperazine in Transfusion Dependent DBA,"Phase I/II, Open Label Study to Determine Safety of Trifluoperazine (TFP) in Adults With Red Blood Cell Transfusion-Dependent Diamond Blackfan Anemia",TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,Northwell Health,Protocol closed early due to slow accrual secondary to COVID travel restrictions.,4.0,,Supporter terminated study due to slow subject accrual secondary to COVID pandemic limiting travel to research site.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,OTHER,,,,,,,2021,0.0
NCT05329545,,2022-03-24,,,2023-10-24,2022-04-07,2022-04-15,ACTUAL,,,,,,,2023-10-24,2023-10-26,ACTUAL,2022-06-23,ACTUAL,2022-06-23,2023-10,2023-10-31,2023-09-29,ACTUAL,2023-09-29,2023-09-29,ACTUAL,2023-09-29,,INTERVENTIONAL,UP-NEXT,,Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT),"A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Upifitamab Rilsodotin (XMT-1536) as Post-Platinum Maintenance Therapy for Participants With Recurrent, Platinum-Sensitive, Ovarian Cancer (UP-NEXT)",TERMINATED,,PHASE3,20.0,ACTUAL,Mersana Therapeutics,,2.0,,Study Terminated by Sponsor,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,INDUSTRY,,,,,,,2023,0.0
NCT05386368,,2022-05-17,2024-06-20,,2024-08-01,2022-05-17,2022-05-23,ACTUAL,2024-08-01,2024-08-09,ACTUAL,,,,2024-08-01,2024-08-09,ACTUAL,2023-03-22,ACTUAL,2023-03-22,2024-03,2024-03-31,2024-05-06,ACTUAL,2024-05-06,2023-07-07,ACTUAL,2023-07-07,,INTERVENTIONAL,,We only had one subject total and she received (A) Right receives Recell,RECELL to Promote Healing Following Carbon Dioxide (CO2) Laser Treatment in Cosmetic Patients,Application of RECELL to Promote Healing Following CO2 Laser Treatment in Cosmetic Facelift Patients,TERMINATED,,PHASE4,1.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. PI decided to terminate due to slow enrollment.,f,,,,t,t,f,,,f,,,,,,NO,We do not plan on sharing individual participant data with other researchers at this time.,2024-10-16 11:22:33.405328,2024-10-16 11:22:33.405328,OTHER,,,,,,,2024,0.0
NCT00455039,,2007-03-30,,,2023-08-09,2007-03-30,2007-04-03,ESTIMATED,,,,,,,2023-08-09,2023-08-14,ACTUAL,2023-07-31,ACTUAL,2023-07-31,2023-07,2023-07-31,2023-07-31,ACTUAL,2023-07-31,2023-07-31,ACTUAL,2023-07-31,,INTERVENTIONAL,,,INST 0514C- Biologic Correlative Study: Trial of GW572016 in HER2 Overexpressing Breast Cancer Patients,INST 0514C- A Neoadjuvant Phase II Trial of GW572016 in HER2 Overexpressing Breast Cancer Patients: Biologic Correlative Study,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of New Mexico,,1.0,,This is a duplicate record and the sponsor has submitted under NCT00206427.,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 11:22:33.405328,2024-10-16 11:22:33.405328,OTHER,,,,,,,2023,0.0
NCT04188431,,2019-12-01,,,2024-04-16,2019-12-03,2019-12-05,ACTUAL,,,,,,,2024-04-16,2024-04-18,ACTUAL,2020-11-01,ACTUAL,2020-11-01,2024-04,2024-04-30,2024-03-01,ACTUAL,2024-03-01,2023-03-30,ACTUAL,2023-03-30,,INTERVENTIONAL,Blueberry,,Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children,"Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children: Double-blind, Randomized, Placebo Control, Multi-centre, International, Pragmatic, Non-inferiority Trial",TERMINATED,,PHASE4,523.0,ACTUAL,"University Hospital, Geneva",,2.0,,Lack of finance,f,,,,t,f,f,,,,,,Up to 2 years following study completion,Data access requests from National coordinators or from local investigators will be examined by the steering committee and an agreement will be signed prior to Data access,,YES,De-identified individual participant data for all primary and secondary outcome measures will be made available,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,OTHER,,,,,,,2024,0.0
NCT02539160,,2015-08-31,2021-11-02,,2022-01-26,2015-08-31,2015-09-02,ESTIMATED,2022-01-26,2022-01-28,ACTUAL,,,,2022-01-26,2022-01-28,ACTUAL,2016-02,ACTUAL,2016-02-29,2022-01,2022-01-31,2020-06-17,ACTUAL,2020-06-17,2019-11-14,ACTUAL,2019-11-14,,INTERVENTIONAL,,"77 patients (DM-CKD, n=38; DM-non-CKD, n=39) had pharmacodynamic (PD) data on study drug and represented the PD population that was used for the analysis.",Impact of Chronic Kidney Disease on the Effects of Ticagrelor in Patients With Diabetes and Coronary Artery Disease,Impact of Chronic Kidney Disease on the Pharmacodynamic and Pharmacokinetic Effects of Ticagrelor in Patients With Diabetes Mellitus and Coronary Artery Disease,COMPLETED,,PHASE4,101.0,ACTUAL,University of Florida,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 11:22:33.405328,2024-10-16 11:22:33.405328,OTHER,,,,,,,2020,1.0
NCT03406780,,2018-01-15,,,2020-06-03,2018-01-19,2018-01-23,ACTUAL,,,,,,,2020-06-03,2020-06-05,ACTUAL,2018-03-04,ACTUAL,2018-03-04,2020-06,2020-06-30,2020-03-10,ACTUAL,2020-03-10,2020-03-10,ACTUAL,2020-03-10,,INTERVENTIONAL,HOPE-2,,A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects With Duchenne Muscular Dystrophy",COMPLETED,,PHASE2,18.0,ACTUAL,Capricor Inc.,,2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 11:22:33.405328,2024-10-16 11:22:33.405328,INDUSTRY,,,,,,,2020,1.0
NCT05604521,,2022-10-28,,,2024-01-18,2022-10-28,2022-11-03,ACTUAL,,,,,,,2024-01-18,2024-01-19,ACTUAL,2022-12-06,ACTUAL,2022-12-06,2024-01,2024-01-31,2023-09-05,ACTUAL,2023-09-05,2023-09-05,ACTUAL,2023-09-05,,INTERVENTIONAL,,,"A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous CHMI","A Randomized, Double-blind, Placebo-controlled, Clinical Trial of a 3-dose, 28-day Regimen of PfSPZ Vaccine in Healthy, Adult Participants to Determine Safety, Tolerability and Efficacy Against Heterologous Plasmodium Falciparum Controlled Human Malaria Infection Conducted 3 or 12 Weeks After Immunization",TERMINATED,,PHASE1,60.0,ACTUAL,Sanaria Inc.,,4.0,,The main reason for trial discontinuation was the inability to address the primary objectives of the study following an extended gap between the second and third doses.,f,,,,,t,f,,,,,,,,,,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,INDUSTRY,,,,,,,2023,0.0
NCT04592861,,2020-09-11,,,2024-01-02,2020-10-13,2020-10-19,ACTUAL,,,,,,,2024-01-02,2024-01-05,ACTUAL,2020-11-01,ACTUAL,2020-11-01,2024-01,2024-01-31,2022-08-24,ACTUAL,2022-08-24,2022-08-24,ACTUAL,2022-08-24,,INTERVENTIONAL,,,Carbon Ion RT for Locally Advanced Pancreatic Cancer,"A Prospective, Randomized, Phase 3 Trial of Carbon Ion Radiation Therapy Versus Standard Care for Locally Advanced Pancreatic Cancer",TERMINATED,,PHASE3,5.0,ACTUAL,Albert Einstein College of Medicine,,2.0,,Study administratively closed out by the Einstein IRB. NO US enrolling sites.,f,,,,t,f,f,,,t,,,,,,NO,,2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,OTHER,,,,,,,2022,0.0
NCT02593786,,2015-10-30,2022-09-26,,2022-09-26,2015-10-30,2015-11-01,ESTIMATED,2022-09-26,2022-10-24,ACTUAL,,,,2022-09-26,2022-10-24,ACTUAL,2016-01-07,ACTUAL,2016-01-07,2022-09,2022-09-30,2021-09-27,ACTUAL,2021-09-27,2021-09-27,ACTUAL,2021-09-27,,INTERVENTIONAL,CheckMate 077,,"A Study of Safety, Tolerability and Pharmacokinetics of Nivolumab in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors","A Phase 1/2, Open-Label Study of Nivolumab (BMS-936558) in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors (CheckMate 077: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 077)",COMPLETED,,PHASE1/PHASE2,58.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,INDUSTRY,,,,,,,2021,1.0
NCT03507374,,2018-04-13,,,2020-04-18,2018-04-13,2018-04-25,ACTUAL,,,,,,,2020-04-18,2020-04-21,ACTUAL,2018-10-30,ACTUAL,2018-10-30,2020-04,2020-04-30,2020-04-17,ACTUAL,2020-04-17,2020-04-17,ACTUAL,2020-04-17,,INTERVENTIONAL,PINNACLE,,PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis,PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis,TERMINATED,,EARLY_PHASE1,20.0,ACTUAL,University of Utah,,2.0,,Funding withdrawn,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 01:49:08.079671,2024-10-16 01:49:08.079671,OTHER,,,,,,,2020,0.0
NCT04372121,,2020-04-29,,,2023-01-12,2020-04-29,2020-05-01,ACTUAL,,,,,,,2023-01-12,2023-01-13,ACTUAL,2020-03-23,ACTUAL,2020-03-23,2021-12,2021-12-31,2021-02-16,ACTUAL,2021-02-16,2021-01-08,ACTUAL,2021-01-08,,INTERVENTIONAL,EDELWEISS 5,,Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain,A Double-blind Randomized Extension Study to Assess the Long-term Efficacy and Safety of Linzagolix in Subjects With Endometriosis-associated Pain,TERMINATED,,PHASE3,30.0,ACTUAL,"Kissei Pharmaceutical Co., Ltd.",,2.0,,"This study is an extension of Study 18-OBE2109-002 that has been terminated due to enrolment challenges. Consequently, this study has also been terminated.",f,,,,t,t,f,,,,,,,,,,,2024-10-16 11:22:33.405328,2024-10-16 11:22:33.405328,INDUSTRY,,,,,,,2021,0.0
NCT04718376,,2020-12-14,,,2024-03-05,2021-01-20,2021-01-22,ACTUAL,,,,,,,2024-03-05,2024-03-07,ACTUAL,2021-01-12,ACTUAL,2021-01-12,2021-05,2021-05-31,2023-05-22,ACTUAL,2023-05-22,2023-05-22,ACTUAL,2023-05-22,,INTERVENTIONAL,,,A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed Ovarian Cancer,"A Multicenter, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Platinum-Resistant or Platinum-Refractory Relapsed Ovarian Cancer",TERMINATED,,PHASE1,56.0,ACTUAL,"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.",,1.0,,The sponsor has adjusted its R\&D strategy.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 11:22:33.405328,2024-10-16 11:22:33.405328,INDUSTRY,,,,,,,2023,0.0
NCT03580616,,2018-06-26,,,2023-09-06,2018-06-26,2018-07-09,ACTUAL,,,,,,,2023-09-06,2023-09-07,ACTUAL,2018-10-24,ACTUAL,2018-10-24,2023-08,2023-08-31,2022-12-20,ACTUAL,2022-12-20,2022-08-03,ACTUAL,2022-08-03,,INTERVENTIONAL,ALS,,Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis (ALS),Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis: A Phase IIa Study,TERMINATED,,PHASE2,43.0,ACTUAL,Dartmouth-Hitchcock Medical Center,,1.0,,Study was terminated by the IRB due to continued noncompliance.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,OTHER,,,,,,,2022,0.0
NCT04209621,,2019-12-21,2021-12-20,,2022-02-15,2019-12-21,2019-12-24,ACTUAL,2022-02-15,2022-03-09,ACTUAL,,,,2022-02-15,2022-03-09,ACTUAL,2020-07-31,ACTUAL,2020-07-31,2022-02,2022-02-28,2021-01-22,ACTUAL,2021-01-22,2021-01-22,ACTUAL,2021-01-22,,INTERVENTIONAL,,,Duvelisib for Ibrutinib-Resistant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma,Duvelisib for Ibrutinib-Resistant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL),TERMINATED,,PHASE2,3.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,Due to unexpected sudden death on study.,f,,,,,t,f,,,,,,,,,,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,NIH,,,,,,,2021,0.0
NCT05900674,,2023-05-28,,,2024-04-05,2023-05-28,2023-06-12,ACTUAL,,,,,,,2024-04-05,2024-04-09,ACTUAL,2023-07,ESTIMATED,2023-07-31,2023-05,2023-05-31,2024-07,ESTIMATED,2024-07-31,2024-07,ESTIMATED,2024-07-31,,INTERVENTIONAL,[ESTAR],,Endovascular Stroke Treatment And Reteplase Protocol,Endovascular Stroke Treatment And Reteplase Protocol,WITHDRAWN,,PHASE2,0.0,ACTUAL,Zeenat Qureshi Stroke Institute,,3.0,,Sponsor,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 11:22:33.405328,2024-10-16 11:22:33.405328,OTHER,,,,,,,2024,0.0
NCT03001349,,2016-12-20,,,2021-02-11,2016-12-20,2016-12-23,ESTIMATED,,,,,,,2021-02-11,2021-02-15,ACTUAL,2017-05-16,ACTUAL,2017-05-16,2021-02,2021-02-28,2021-02-05,ACTUAL,2021-02-05,2021-02-05,ACTUAL,2021-02-05,,INTERVENTIONAL,,,68Ga-DOTA-TOC PET/CT in Imaging Participants With Neuroendocrine Tumors,An Expanded Access Imaging of Neuroendocrine Tumors Using 68Ga-DOTA-TOC,TERMINATED,,EARLY_PHASE1,4.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Per PI Request,,,,,f,t,f,,,,,,,,,,,2024-10-16 23:05:55.307763,2024-10-16 23:05:55.307763,OTHER,,,,,,,2021,0.0
NCT03295656,,2017-09-25,,,2020-07-15,2017-09-25,2017-09-28,ACTUAL,,,,,,,2020-07-15,2020-07-17,ACTUAL,2020-07-15,ACTUAL,2020-07-15,2020-07,2020-07-31,2020-07-15,ACTUAL,2020-07-15,2020-07-15,ACTUAL,2020-07-15,,INTERVENTIONAL,,,Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis,Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis,WITHDRAWN,,PHASE1,0.0,ACTUAL,Boston Children's Hospital,,1.0,,Unanticipated delays.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,OTHER,,,,,,,2020,0.0
NCT04105972,,2019-09-24,2021-07-23,,2021-07-23,2019-09-24,2019-09-26,ACTUAL,2021-07-23,2021-08-18,ACTUAL,,,,2021-07-23,2021-08-18,ACTUAL,2019-10-03,ACTUAL,2019-10-03,2021-07,2021-07-31,2020-07-24,ACTUAL,2020-07-24,2020-07-24,ACTUAL,2020-07-24,,INTERVENTIONAL,,,"A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del","A Phase 3b, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del",COMPLETED,,PHASE3,176.0,ACTUAL,Vertex Pharmaceuticals Incorporated,,2.0,,,t,,,,,t,f,,,,,,,,,NO,Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent research/clinical-trial-data-sharing.,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,INDUSTRY,,NCT04058210,APPROVED_FOR_MARKETING,,,,2020,1.0
NCT05150496,,2021-11-25,,,2022-08-09,2021-11-25,2021-12-09,ACTUAL,,,,,,,2022-08-09,2022-08-11,ACTUAL,2022-12-15,ESTIMATED,2022-12-15,2021-11,2021-11-30,2023-01-15,ESTIMATED,2023-01-15,2023-01-15,ESTIMATED,2023-01-15,,INTERVENTIONAL,,,Immunogenicity and Safety Study of the 3rd Booster Dose Using the High or Medium Dose of Inactivated (CoronaVac®) Vaccine in Healthy Adults in Turkey,A Phase IIb Randomized Double-Blinded Positive Controlled Trial to Evaluate the Immunogenicity and Safety Study of the 3rd Booster Dose Using the High or Medium Dose of Inactivated (CoronaVac®) Vaccine in Healthy Adults Who Have Completed Two Doses of CoronaVac® or the mRNA Vaccine (Comirnaty) in Turkey,SUSPENDED,,PHASE2,640.0,ESTIMATED,"Sinovac Biotech Co., Ltd",,4.0,,The plan has changed,f,,,,f,f,f,,,,,,,,,,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2023,0.0
NCT05665088,,2022-12-16,,2023-12-04,2023-12-08,2022-12-16,2022-12-27,ACTUAL,,,,,2023-12-06,ACTUAL,2023-12-08,2023-12-11,ACTUAL,2022-12-14,ACTUAL,2022-12-14,2023-12,2023-12-31,2023-09-11,ACTUAL,2023-09-11,2023-09-11,ACTUAL,2023-09-11,,INTERVENTIONAL,,,Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III),"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of PRN Dosing of BXCL501 Over a 12 Week Treatment Period in Subjects With Agitation Associated With Dementia",TERMINATED,,PHASE3,13.0,ACTUAL,BioXcel Therapeutics Inc,,3.0,,Study was terminated for business reasons; not due to safety or efficacy concerns,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2023,0.0
NCT03690141,,2018-09-10,2023-10-04,,2024-06-18,2018-09-27,2018-10-01,ACTUAL,2024-06-18,2024-06-21,ACTUAL,,,,2024-06-18,2024-06-21,ACTUAL,2018-11-27,ACTUAL,2018-11-27,2024-06,2024-06-30,2020-04-27,ACTUAL,2020-04-27,2020-04-27,ACTUAL,2020-04-27,,INTERVENTIONAL,,,An Open-label Study of the Effect of Tomivosertib (eFT508) in Patients With Advanced Castrate-resistant Prostate Cancer,A Phase 2 Non-randomized Open-label Study Examining the Effect of Tomivosertib (eFT508) in Patients With Advanced Castrate-resistant Prostate Cancer (CRPC),TERMINATED,,PHASE2,16.0,ACTUAL,Effector Therapeutics,,1.0,,Terminated early due to a lack of efficacy.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2020,0.0
NCT04604678,,2020-10-26,,,2022-10-03,2020-10-26,2020-10-27,ACTUAL,,,,,,,2022-10-03,2022-10-04,ACTUAL,2021-02,ESTIMATED,2021-02-28,2022-10,2022-10-31,2021-10,ESTIMATED,2021-10-31,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,,,Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19,Pilot Study Into the Use of Metformin and Low Dose Naltrexone (LDN) for Patients With Coronavirus Disease 2019 (COVID-19) - Assessment of Short and Long Term Effects,WITHDRAWN,,PHASE2,0.0,ACTUAL,AgelessRx,,2.0,,Unable to recruit participants due to restrictive inclusion/exclusion criteria. Will update protocol with IRB \& begin anew after approval.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2021,0.0
NCT03192995,,2017-06-12,2021-08-23,2021-02-05,2023-08-09,2017-06-19,2017-06-20,ACTUAL,2023-08-09,2023-08-14,ACTUAL,,2023-08-14,ACTUAL,2023-08-09,2023-08-14,ACTUAL,2018-01-01,ACTUAL,2018-01-01,2023-08,2023-08-31,2020-06-30,ACTUAL,2020-06-30,2020-02-28,ACTUAL,2020-02-28,,INTERVENTIONAL,TLC,Treatment and control assignments,Treatment With Lorcaserin for Cocaine Use: The TLC Study,Treatment With Lorcaserin for Cocaine Use: The TLC Study,TERMINATED,,PHASE2,22.0,ACTUAL,"University of California, San Francisco",The study was terminated early by the FDA due to the publication of a long-term safety study that showed an increase risk for cancer by the lorcaserin arm.,2.0,,FDA alert regarding study drug safety,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,OTHER,,,,,,,2020,0.0
NCT03503513,,2018-04-06,2024-03-14,,2024-05-29,2018-04-11,2018-04-19,ACTUAL,2024-05-29,2024-06-25,ACTUAL,,,,2024-05-29,2024-06-25,ACTUAL,2018-08-24,ACTUAL,2018-08-24,2024-05,2024-05-31,2023-09-30,ACTUAL,2023-09-30,2023-09-08,ACTUAL,2023-09-08,,INTERVENTIONAL,,Baseline data is provided for all participants who started treatment,Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury,The Effect of Gentamicin Intravesical Installations on Decreasing Urinary Tract Infections in Patients With Neurogenic Bladder After Spinal Cord Injury: A Clinical Trial,COMPLETED,,PHASE2/PHASE3,23.0,ACTUAL,University of Michigan,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,OTHER,,,,,,,2023,1.0
NCT01058902,,2010-01-26,,,2016-03-04,2010-01-28,2010-01-29,ESTIMATED,,,,,,,2016-03-04,2016-03-07,ESTIMATED,2010-08,,2010-08-31,2016-03,2016-03-31,2020-08,ESTIMATED,2020-08-31,2015-08,ESTIMATED,2015-08-31,,INTERVENTIONAL,,,The Effect Of Aspirin On Survival in Lung Cancer,The Effect Of Aspirin On Survival Following Potentially Curative Resection Of Non Small Cell Carcinoma Of The Lung The Big A Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,Liverpool Heart and Chest Hospital NHS Foundation Trust,,4.0,,failed to achive funding,f,,,,t,,,,,,,,,,,,,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,OTHER,,,,,,,2020,0.0
NCT04672564,,2020-12-16,,,2023-02-22,2020-12-16,2020-12-17,ACTUAL,,,,,,,2023-02-22,2023-02-23,ACTUAL,2021-03-30,ACTUAL,2021-03-30,2023-02,2023-02-28,2022-05-09,ACTUAL,2022-05-09,2022-03-24,ACTUAL,2022-03-24,,INTERVENTIONAL,,,Study to Evaluate Safety and Efficacy of Carrimycin for Treatment of Severe Coronavirus Disease 2019 (COVID-19) in Hospitalized Patients,"A Phase 3, Randomized, Multicenter, Placebo-controlled, Double-blind Clinical Study of the Safety and Efficacy of Carrimycin for Treatment of Severe COVID-19 in Hospitalized Patients",TERMINATED,,PHASE3,93.0,ACTUAL,"Shenyang Tonglian Group CO., Ltd",,2.0,,sponsor strategy change,,,,,t,t,f,,,,,,,,,,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,INDUSTRY,,,,,,,2022,0.0
NCT03295552,,2017-09-20,,,2022-03-28,2017-09-24,2017-09-28,ACTUAL,,,,,,,2022-03-28,2022-04-06,ACTUAL,2017-11-15,ACTUAL,2017-11-15,2022-03,2022-03-31,2021-06-01,ACTUAL,2021-06-01,2021-06-01,ACTUAL,2021-06-01,,INTERVENTIONAL,DETECT,,Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC,Decitabine Plus Carboplatin in the Treatment of Metastatic Triple Negative Breast Cancer,TERMINATED,,PHASE2,12.0,ACTUAL,Shanghai Jiao Tong University School of Medicine,,1.0,,Slow enrollment.,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,OTHER,,,,,,,2021,0.0
NCT04513704,,2020-08-12,,,2023-05-11,2020-08-12,2020-08-14,ACTUAL,,,,,,,2023-05-11,2023-05-12,ACTUAL,2020-08-28,ACTUAL,2020-08-28,2023-05,2023-05-31,2021-05-26,ACTUAL,2021-05-26,2021-04-20,ACTUAL,2021-04-20,,INTERVENTIONAL,,,A Clinical Trial Comparing Semaglutide in Healthy People Who Eat and Take the Medicine at Different Times,"Oral Semaglutide Pharmacokinetics in Healthy Subjects, Effect of Dosing Schedules",COMPLETED,,PHASE1,156.0,ACTUAL,Novo Nordisk A/S,,5.0,,,f,,,,f,t,f,,,t,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2021,1.0
NCT04956042,,2021-06-30,,,2024-02-09,2021-06-30,2021-07-09,ACTUAL,,,,,,,2024-02-09,2024-02-12,ACTUAL,2021-08-27,ACTUAL,2021-08-27,2024-02,2024-02-29,2023-12-31,ACTUAL,2023-12-31,2023-12-31,ACTUAL,2023-12-31,,INTERVENTIONAL,,,Study of Fosciclopirox in Patients With Relapsed/Refractory Acute Myeloid Leukemia,"A Phase 1B/2A, Open-label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Fosciclopirox Alone and In Combination With Cytarabine in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)",TERMINATED,,PHASE1/PHASE2,18.0,ACTUAL,CicloMed LLC,,2.0,,Discontinued,f,,,,f,t,f,,,,,,,,,,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2023,0.0
NCT02366728,,2014-10-28,2021-10-20,,2023-06-06,2015-02-12,2015-02-19,ESTIMATED,2022-01-03,2022-02-01,ACTUAL,,,,2023-06-06,2023-06-08,ACTUAL,2015-10-12,ACTUAL,2015-10-12,2023-06,2023-06-30,2020-10-31,ACTUAL,2020-10-31,2020-10-31,ACTUAL,2020-10-31,,INTERVENTIONAL,ELEVATE,Participants who received at least one ppp65 vaccine.,DC Migration Study for Newly-Diagnosed GBM,Evaluation of Overcoming Limited Migration and Enhancing Cytomegalovirus-specific Dendritic Cell Vaccines With Adjuvant TEtanus Pre-conditioning in Patients With Newly-diagnosed Glioblastoma,COMPLETED,,PHASE2,64.0,ACTUAL,Duke University,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,OTHER,,,,,,,2020,1.0
NCT05237284,,2022-02-02,,,2024-04-02,2022-02-02,2022-02-14,ACTUAL,,,,,,,2024-04-02,2024-04-03,ACTUAL,2022-04-13,ACTUAL,2022-04-13,2024-04,2024-04-30,2024-03-07,ACTUAL,2024-03-07,2024-03-07,ACTUAL,2024-03-07,,INTERVENTIONAL,HIMALAYA,,Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS),"A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR443820 in Adult Participants With Amyotrophic Lateral Sclerosis, Followed by an Open-label Extension",TERMINATED,,PHASE2,305.0,ACTUAL,Sanofi,,2.0,,The study was terminated as its Part A did not meet the primary endpoint.,f,,,,t,t,f,,,f,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,INDUSTRY,,,,,,,2024,0.0
NCT02653300,,2015-12-24,2021-07-27,,2024-03-12,2016-01-08,2016-01-12,ESTIMATED,2021-08-27,2021-09-23,ACTUAL,,,,2024-03-12,2024-03-13,ACTUAL,2018-09-20,ACTUAL,2018-09-20,2024-03,2024-03-31,2020-04-01,ACTUAL,2020-04-01,2020-03-01,ACTUAL,2020-03-01,,INTERVENTIONAL,,,A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH),"An Open-Label Pilot Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Potential of Oral Insulin to Reduce Liver Fat Content and Fibrosis in Patients With Nonalcolholic Steatohepatitis (NASH)",COMPLETED,,PHASE2,10.0,ACTUAL,"Oramed, Ltd.","This is a pilot study with ten subjects enrolled, and eight subjects analyzed.",1.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2020,1.0
NCT06037408,,2023-09-07,2024-06-13,,2024-07-11,2023-09-07,2023-09-14,ACTUAL,2024-06-13,2024-07-09,ACTUAL,,,,2024-07-11,2024-08-07,ACTUAL,2023-08-15,ACTUAL,2023-08-15,2024-07,2024-07-31,2024-05-20,ACTUAL,2024-05-20,2024-05-16,ACTUAL,2024-05-16,,INTERVENTIONAL,,,The Effect of N115 on Coughing in IPF Patients,The Effect of Sodium Pyruvate Nasal Spray on Coughing in Patients With Idiopathic Pulmonary Fibrosis,COMPLETED,,PHASE3,50.0,ACTUAL,"Cellular Sciences, inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,INDUSTRY,,,,,,,2024,1.0
NCT06032936,,2023-07-31,,,2024-06-24,2023-09-04,2023-09-13,ACTUAL,,,,,,,2024-06-24,2024-06-25,ACTUAL,2023-07-27,ACTUAL,2023-07-27,2024-06,2024-06-30,2024-03-29,ACTUAL,2024-03-29,2024-03-29,ACTUAL,2024-03-29,,INTERVENTIONAL,,,BBP-398 in Combination With Osimertinib in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutations,"An Open-label, Non-randomized, Multi-cohort, Multi-center Phase Ia/Ib Study Evaluating the Efficacy and Safety of BBP-398 in Combination With Osimertinib in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutations",TERMINATED,,PHASE1,4.0,ACTUAL,LianBio LLC,,1.0,,Business reason,f,,,,f,f,f,,,,,,,,,,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2024,0.0
NCT04656262,,2020-11-25,,,2024-07-04,2020-12-04,2020-12-07,ACTUAL,,,,,,,2024-07-04,2024-07-08,ACTUAL,2018-09-10,ACTUAL,2018-09-10,2024-07,2024-07-31,2024-05-23,ACTUAL,2024-05-23,2024-05-23,ACTUAL,2024-05-23,,INTERVENTIONAL,METROPHOLYS,,Low Dose Continuous Cyclophosphamide vs Standard Doxorubicin in Advanced Sarcoma Elderly Patients,"The METROPHOLYS Study Metronomic Cyclophosphamide vs Doxorubicin in Elderly Patients With Advanced Soft Tissue Sarcomas Randomized, Controlled Open Label Clinical Trial",TERMINATED,,PHASE3,79.0,ACTUAL,Istituto Oncologico Veneto IRCCS,,2.0,,enrollment too slow to reach the target in a reasonable time frame,f,,,,f,f,f,,,,,,,,,,,2024-10-16 11:22:33.405328,2024-10-16 11:22:33.405328,OTHER,,,,,,,2024,0.0
NCT04507061,,2020-08-06,,,2023-03-31,2020-08-06,2020-08-10,ACTUAL,,,,,,,2023-03-31,2023-04-04,ACTUAL,2020-09-01,ACTUAL,2020-09-01,2023-03,2023-03-31,2022-04-05,ACTUAL,2022-04-05,2022-03-08,ACTUAL,2022-03-08,,INTERVENTIONAL,CONCORD,,Study on the Safety of the Drug Runcaciguat and How Well it Works When Given at the Highest Dose as Tolerated by Individual Patient Whose Kidneys Are Not Working Properly and Suffering at the Same Time From High Blood Sugar and/or High Blood Pressure and a Disease of the Heart and the Blood Vessels.,"A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Individually Titrated Oral Doses of Runcaciguat in Subjects With Clinical Diagnosis of Chronic Kidney Disease With Diabetes and/or Hypertension and at Least One Cardiovascular Comorbidity",COMPLETED,,PHASE2,243.0,ACTUAL,Bayer,,2.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,"Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2022,1.0
NCT03952806,,2019-05-15,2023-06-27,2022-07-25,2023-09-06,2019-05-15,2019-05-16,ACTUAL,2023-09-06,2023-09-29,ACTUAL,,2023-09-29,ACTUAL,2023-09-06,2023-09-29,ACTUAL,2019-07-29,ACTUAL,2019-07-29,2023-09,2023-09-30,2022-06-30,ACTUAL,2022-06-30,2021-07-29,ACTUAL,2021-07-29,,INTERVENTIONAL,M-STAR,Treated participants included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).,Study of BHV-3241 in Participants With Multiple System Atrophy,"Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects With Multiple System Atrophy (M-STAR Study)",COMPLETED,,PHASE3,421.0,ACTUAL,"Biohaven Pharmaceuticals, Inc.",,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2022,1.0
NCT03879811,,2019-03-15,,,2019-12-10,2019-03-15,2019-03-19,ACTUAL,,,,,,,2019-12-10,2019-12-12,ACTUAL,2019-03-13,ACTUAL,2019-03-13,2019-12,2019-12-31,2021-03,ESTIMATED,2021-03-31,2021-03,ESTIMATED,2021-03-31,,INTERVENTIONAL,,,Determining the Effects of Temozolomide Followed by Nivolumab in Patients With Colorectal Cancer,Phase II Study of Temozolomide and Nivolumab in MMR-Proficient Colorectal Cancer (CA209-8JN),WITHDRAWN,,PHASE2,0.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,No accrual,f,,,,,t,f,,,,,,,,,YES,"Here is the final approved MSK data sharing statement for posting on any trial opened 1/1/19 or later -~• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-16 11:22:33.405328,2024-10-16 11:22:33.405328,OTHER,,,,,,,2021,0.0
NCT02953366,,2016-11-01,,,2020-11-03,2016-11-01,2016-11-02,ESTIMATED,,,,,,,2020-11-03,2020-11-04,ACTUAL,2019-05,ESTIMATED,2019-05-31,2020-11,2020-11-30,2020-05,ESTIMATED,2020-05-31,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis,"Phase III, National, Multicenter, Randomized, Single-blind, Non-inferiority to Compare the Efficacy of Mometasone Nasal Gel Compared to Mometasone Nasal Spray in the Treatment of Persistent or Intermittent Allergic Rhinitis in Childrens",WITHDRAWN,,PHASE3,0.0,ACTUAL,EMS,,2.0,,Sponsor decision,f,,,,t,f,f,,,,,,,,,,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2020,0.0
NCT04352166,,2020-04-16,,,2024-02-01,2020-04-17,2020-04-20,ACTUAL,,,,,,,2024-02-01,2024-02-02,ACTUAL,2020-12-15,ACTUAL,2020-12-15,2024-02,2024-02-29,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder,Randomized Controlled Trial of Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder Patients Using Fentanyl,SUSPENDED,,PHASE2,40.0,ESTIMATED,New York State Psychiatric Institute,,2.0,,"U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume recruitment after OHRP has approved the resumption of research.",f,,,,f,t,f,,,,,,beginning twelve months and ending 5 years after article publication,to researcher who provides a methodologically sound proposal to achieve aims in approved proposal,,YES,"Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures)",2024-10-16 11:22:33.405328,2024-10-16 11:22:33.405328,OTHER,,,,,,,2024,0.0
NCT03817034,,2018-11-23,,,2021-03-28,2019-01-24,2019-01-25,ACTUAL,,,,,,,2021-03-28,2021-04-01,ACTUAL,2021-03-11,ACTUAL,2021-03-11,2021-03,2021-03-31,2021-03-11,ACTUAL,2021-03-11,2021-03-11,ACTUAL,2021-03-11,,INTERVENTIONAL,,,Multimodal Analgesia for the Reduction of Postoperative Opioid Consumption,Multimodal Analgesia for the Reduction of Postoperative Opioid Consumption,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Massachusetts General Hospital,,1.0,,We decided to close this study and come up with a new study design.,,,,,,t,f,,,f,,,,,,,,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,OTHER,,,,,,,2021,0.0
NCT04356352,,2020-04-19,2024-08-09,,2024-09-09,2020-04-19,2020-04-22,ACTUAL,2024-09-09,2024-09-19,ACTUAL,,,,2024-09-09,2024-09-19,ACTUAL,2020-09-09,ACTUAL,2020-09-09,2023-09,2023-09-30,2023-08-25,ACTUAL,2023-08-25,2023-08-25,ACTUAL,2023-08-25,,INTERVENTIONAL,,,"Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain","A Comparison of Lidocaine, Esmolol, and Placebo Without Use of a Tourniquet for Relieving Pain From Intravenous Administration of Propofol",TERMINATED,,PHASE2/PHASE3,33.0,ACTUAL,Wake Forest University Health Sciences,,3.0,,feasibility of enrollment,f,,,,f,t,f,,,t,,,,,,,,2024-10-15 01:26:40.947049,2024-10-15 01:26:40.947049,OTHER,,,,,,,2023,0.0
NCT03430063,,2018-01-29,2022-10-10,,2022-10-10,2018-02-09,2018-02-12,ACTUAL,2022-10-10,2022-11-03,ACTUAL,,,,2022-10-10,2022-11-03,ACTUAL,2018-05-29,ACTUAL,2018-05-29,2022-10,2022-10-31,2021-10-27,ACTUAL,2021-10-27,2021-10-27,ACTUAL,2021-10-27,,INTERVENTIONAL,,Safety analysis set (SAF) included all randomized participants who received any study drug; it is based on the treatment received (as treated).,A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer,"A Randomized, Open-Label Study of Combinations of Standard and High Dose REGN2810 (Cemiplimab; Anti-PD-1 Antibody) and Ipilimumab (Anti-CTLA-4 Antibody) in the Second-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer",TERMINATED,,PHASE2,28.0,ACTUAL,Regeneron Pharmaceuticals,"All participants' tumors had PD-L1 expression levels of \<50% at baseline. Therefore, the results do not present efficacy for participants with PD-L1 expression levels of ≥50% of tumor cells versus all participants.",3.0,,Business decision,f,,,,t,t,f,,,,,,,,,,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,INDUSTRY,,,,,,,2021,0.0
NCT03002519,,2016-12-13,,,2022-12-15,2016-12-20,2016-12-23,ESTIMATED,,,,,,,2022-12-15,2022-12-16,ACTUAL,2017-02-08,ACTUAL,2017-02-08,2022-12,2022-12-31,2021-10-30,ACTUAL,2021-10-30,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,,,Safety Evaluation of Intramuscular Injections of PLX-R18 in Subjects With Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation,A Phase I Open-label Dose-escalation Study to Evaluate the Safety of Intramuscular Injections of PLX-R18 in Subjects With Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation,COMPLETED,,PHASE1,21.0,ACTUAL,Pluristem Ltd.,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2021,1.0
NCT03321734,,2017-10-23,,,2023-08-30,2017-10-23,2017-10-26,ACTUAL,,,,,,,2023-08-30,2023-09-01,ACTUAL,2019-01-18,ACTUAL,2019-01-18,2023-08,2023-08-31,2023-06-01,ACTUAL,2023-06-01,2023-06-01,ACTUAL,2023-06-01,,INTERVENTIONAL,ICAF,,Intermittent Hypoxia and Caffeine in Infants Born Preterm,Intermittent Hypoxia and Caffeine in Infants Born Preterm (ICAF),COMPLETED,,PHASE2,170.0,ACTUAL,Children's National Research Institute,,2.0,,,f,,,,t,t,f,,,f,,,Starting 6 months after publication,De-identified patient data will be made available to other investigators at their request providing written required IRB (institutional review board) approval in obtained.,,YES,"The Executive Committee will be responsible for developing publication procedures and resolving authorship issues.~This study will be conducted in accordance with the National Institutes of Health (NIH) Public Access Policy, ensuring that the public has access to the published results of NIH funded research. Scientists are required to submit final peer-reviewed journal manuscripts that arise from NIH funds to PubMed Central upon acceptance for publication. This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. This trial will be registered at, and results from, submitted to ClinicalTrials.gov. Every attempt will be made to publish results in peer-reviewed journals. Data may be requested from other researchers starting 6 months after the completion of the primary endpoint by contacting the DCC(data collection center).",2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,OTHER,,,,,,,2023,1.0
NCT04635683,,2020-11-13,,,2022-09-28,2020-11-13,2020-11-19,ACTUAL,,,,,,,2022-09-28,2022-09-30,ACTUAL,2022-09-30,ESTIMATED,2022-09-30,2022-09,2022-09-30,2024-12-31,ESTIMATED,2024-12-31,2023-12-31,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,"Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma","A Phase I Trial of Lenalidomide, Umbralisib and Ublituximab in Patients With Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma",WITHDRAWN,,PHASE1,0.0,ACTUAL,Ohio State University Comprehensive Cancer Center,,1.0,,Investigational Drug removed from the market,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,OTHER,,,,,,,2024,0.0
NCT04637698,,2020-11-16,,,2023-11-21,2020-11-16,2020-11-20,ACTUAL,,,,,,,2023-11-21,2023-11-24,ACTUAL,2021-02-02,ACTUAL,2021-02-02,2023-11,2023-11-30,2023-05-04,ACTUAL,2023-05-04,2023-05-04,ACTUAL,2023-05-04,,INTERVENTIONAL,,,OH2 Oncolytic Viral Therapy in Pancreatic Cancer,"Phase Ib/II Study of OH2 Injection, an Oncolytic Type 2 Herpes Simplex Virus Expressing Granulocyte Macrophage Colony-Stimulating Factor, in Pancreatic Cancer",TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,"Binhui Biopharmaceutical Co., Ltd.",,1.0,,Strategy adjustment,f,,,,,f,f,,,,,,,,,,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2023,0.0
NCT03249714,,2017-08-11,2021-07-23,,2022-04-27,2017-08-11,2017-08-15,ACTUAL,2021-12-02,2022-02-18,ACTUAL,,,,2022-04-27,2022-04-29,ACTUAL,2018-03-15,ACTUAL,2018-03-15,2022-04,2022-04-30,2020-07-29,ACTUAL,2020-07-29,2019-12-26,ACTUAL,2019-12-26,,INTERVENTIONAL,,,Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab,"A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab",COMPLETED,,PHASE2,64.0,ACTUAL,Novartis,,2.0,,,f,,,,t,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.",2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2020,1.0
NCT03954041,,2019-05-15,2023-11-29,,2024-04-26,2019-05-15,2019-05-17,ACTUAL,2023-11-29,2023-12-20,ACTUAL,,,,2024-04-26,2024-04-30,ACTUAL,2019-10-06,ACTUAL,2019-10-06,2023-11,2023-11-30,2023-06-27,ACTUAL,2023-06-27,2023-06-27,ACTUAL,2023-06-27,,INTERVENTIONAL,ASTRAL,All dosed population included all the randomized participants who received any study drug (BIIB093 or a placebo).,A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion,"A Multicenter, Double-Blind, Multidose, Placebo-Controlled, Randomized, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Patients With Brain Contusion",TERMINATED,,PHASE2,92.0,ACTUAL,"Remedy Pharmaceuticals, Inc.","Early termination of trial due to strategic considerations, not for efficacy or safety reasons.",3.0,,"Early completed due to strategic considerations, not for efficacy or safety reasons.",f,,,,f,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,INDUSTRY,,,,,,,2023,0.0
NCT03538691,,2018-04-13,2023-07-06,,2023-10-10,2018-05-24,2018-05-29,ACTUAL,2023-10-10,2023-10-12,ACTUAL,,,,2023-10-10,2023-10-12,ACTUAL,2018-07-13,ACTUAL,2018-07-13,2023-10,2023-10-31,2022-07-29,ACTUAL,2022-07-29,2022-07-08,ACTUAL,2022-07-08,,INTERVENTIONAL,,Enrolled Sample included all participants who signed the informed consent form and entered Phase A.,"A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole as Adjunctive Therapy in the Maintenance Treatment of Adults With Major Depressive Disorder",COMPLETED,,PHASE3,1149.0,ACTUAL,"Otsuka Pharmaceutical Development & Commercialization, Inc.",,4.0,,,f,,,,,t,f,,,,,,"Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.",Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/,https://clinical-trials.otsuka.com,YES,Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,INDUSTRY,,,,,,,2022,1.0
NCT04145037,,2019-08-27,2023-11-09,,2024-01-04,2019-10-28,2019-10-30,ACTUAL,2024-01-04,2024-01-18,ACTUAL,,,,2024-01-04,2024-01-18,ACTUAL,2019-05-30,ACTUAL,2019-05-30,2023-10,2023-10-31,2023-08-21,ACTUAL,2023-08-21,2023-08-21,ACTUAL,2023-08-21,,INTERVENTIONAL,,Treatment-naïve arm did not enroll any subjects at the time of study termination.,Lentiviral Vector Gene Therapy - The Guard1 Trial of AVR-RD-02 for Subjects With Type 1 Gaucher Disease,"The Guard1 Trial, an Open-Label, Multinational Phase 1/2 Study of the Safety and Efficacy of Ex Vivo, Lentiviral Vector-Mediated Gene Therapy AVR-RD-02 for Subjects With Type 1 Gaucher Disease",TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,AVROBIO,"GCase PBL results were not available at many timepoints due to sample instability. CFB in chitotriosidase was calculated for only 2 subjects because timepoints for the other 2 subjects exceeded ULOQ of the assay and could not be quantified. BMA samples were collected and batched for VCN analysis, but due to study termination, they were not analyzed and thus discarded. Change from baseline BMD scores were not able to be evaluated for some subjects due to missing baseline and/or Week 52 data.",2.0,,This study was voluntarily terminated by the sponsor to halt development and was not based on any safety or medical reasons.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,INDUSTRY,,,,,,,2023,0.0
NCT04412837,,2020-05-21,,,2023-01-17,2020-05-29,2020-06-02,ACTUAL,,,,,,,2023-01-17,2023-01-19,ACTUAL,2022-10,ESTIMATED,2022-10-31,2023-01,2023-01-31,2024-02,ESTIMATED,2024-02-29,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,The Use of Cannabinoid Patch for Knee Osteoarthritis,The Use of Cannabinoid Patch for Knee Osteoarthritis,WITHDRAWN,,PHASE2,0.0,ACTUAL,Northwell Health,,2.0,,Inadequate funding,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,OTHER,,,,,,,2024,0.0
NCT04930562,,2021-06-11,2023-10-08,,2023-12-26,2021-06-11,2021-06-18,ACTUAL,2023-10-08,2023-11-01,ACTUAL,,,,2023-12-26,2024-01-17,ACTUAL,2021-04-27,ACTUAL,2021-04-27,2023-12,2023-12-31,2022-12-10,ACTUAL,2022-12-10,2022-06-10,ACTUAL,2022-06-10,,INTERVENTIONAL,,,Efficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD),"A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of BN101 in Subject With Chronic Graft Versus Host Disease (cGVHD) After at Least Fist Line of Systemic Therapy",COMPLETED,,PHASE2,30.0,ACTUAL,BioNova Pharmaceuticals (Shanghai) LTD.,,1.0,,,f,,,,,t,f,,,t,,,,,,,,2024-10-16 11:22:33.405328,2024-10-16 11:22:33.405328,INDUSTRY,,,,,,,2022,1.0
NCT04326868,,2020-03-04,,,2021-07-26,2020-03-26,2020-03-30,ACTUAL,,,,,,,2021-07-26,2021-08-02,ACTUAL,2019-11-11,ACTUAL,2019-11-11,2021-07,2021-07-31,2021-01-30,ACTUAL,2021-01-30,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,BenziR,,Human Soil Transmitted Helminths (STH) Resistance to Benzimidazole in School Aged Children Living in Gabon,Human Soil Transmitted Helminths (STH) Resistance to Benzimidazole in School Aged Children Living in Gabon,COMPLETED,,PHASE4,255.0,ACTUAL,Centre de Recherche Médicale de Lambaréné,,3.0,,,f,,,,f,t,f,,,t,,,The date will be available around December 2020 until september 2021.,The Data will be shared12 months after study completion in research journal. A lle the result will be publicly available the,,YES,The Data will be shared in RedCap database.,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,OTHER,,,,,,,2021,1.0
NCT03258008,,2017-08-21,2022-11-01,,2022-11-22,2017-08-21,2017-08-22,ACTUAL,2022-11-22,2022-12-16,ACTUAL,,,,2022-11-22,2022-12-16,ACTUAL,2018-04-04,ACTUAL,2018-04-04,2022-11,2022-11-30,2021-11-05,ACTUAL,2021-11-05,2021-11-05,ACTUAL,2021-11-05,,INTERVENTIONAL,,All participants who signed the consent are included in the baseline characteristics.,Utomilumab and ISA101b Vaccination in Patients With HPV-16-Positive Incurable Oropharyngeal Cancer,Phase II Trial of Utomilumab and ISA101b Vaccination in Patients With HPV-16-Positive Incurable Oropharyngeal Cancer,TERMINATED,,PHASE2,3.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Closed the trial for infeasibility due to slow accrual,f,,,,f,t,f,,,,,,,,,,,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,OTHER,,,,,,,2021,0.0
NCT05399290,,2022-05-26,2022-10-26,,2023-03-07,2022-05-26,2022-06-01,ACTUAL,2023-03-07,2023-04-03,ACTUAL,,,,2023-03-07,2023-04-03,ACTUAL,2020-11-19,ACTUAL,2020-11-19,2023-03,2023-03-31,2021-11-08,ACTUAL,2021-11-08,2021-11-08,ACTUAL,2021-11-08,,INTERVENTIONAL,,,Subantimicrobial Doxycycline in Acne,A Randomized Controlled Trial Investigating the Pediatric Patient Experience of Subantimicrobial Dose Doxycycline for Acne Treatment,COMPLETED,,PHASE4,22.0,ACTUAL,Michigan State University,,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,OTHER,,,,,,,2021,1.0
NCT04075136,,2019-08-29,,,2024-03-20,2019-08-29,2019-08-30,ACTUAL,,,,,,,2024-03-20,2024-03-22,ACTUAL,2023-03-30,ACTUAL,2023-03-30,2023-04,2023-04-30,2024-12,ESTIMATED,2024-12-31,2024-11,ESTIMATED,2024-11-30,,INTERVENTIONAL,,,Optical Coherence Tomography Angiography (OCTA) - Directed PDT Triple Therapy,OCTA-Directed PDT Triple Therapy for Treatment-Naïve Patients With Exudative Age-Related Macular Degeneration Versus Standard of Care Anti-VEGF(Anti-vascular Endothelial Growth Factor) Monotherapy,WITHDRAWN,,PHASE4,0.0,ACTUAL,Wake Forest University Health Sciences,,3.0,,IRB stopped study due to safety concerns before any participants were enrolled.,f,,,,f,t,t,,,,,,,,,NO,Results will updated once final analysis is complete.,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,OTHER,,,,,,,2024,0.0
NCT03104270,,2017-02-27,,,2022-03-15,2017-04-06,2017-04-07,ACTUAL,,,,,,,2022-03-15,2022-03-31,ACTUAL,2017-03-13,ACTUAL,2017-03-13,2022-03,2022-03-31,2020-01-23,ACTUAL,2020-01-23,2019-10-25,ACTUAL,2019-10-25,,INTERVENTIONAL,,,Combination Study for High Risk Multiple Myeloma Patients,"A Phase 2 Trial of the Efficacy and Safety of Elotuzumab in Combination With Pomalidomide, Carfilzomib and Dexamethasone Among High Risk Relapsed/ Refractory Multiple Myeloma Patients",TERMINATED,,PHASE2,13.0,ACTUAL,Oncotherapeutics,,1.0,,The study was terminated early by Funding Sponsor due to low enrollment.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 11:22:33.405328,2024-10-16 11:22:33.405328,INDUSTRY,,,,,,,2020,0.0
NCT02061293,,2014-02-07,2022-09-19,,2022-10-18,2014-02-10,2014-02-12,ESTIMATED,2022-09-19,2022-10-18,ACTUAL,,,,2022-10-18,2022-11-08,ACTUAL,2014-06,ACTUAL,2014-06-30,2022-10,2022-10-31,2021-07-30,ACTUAL,2021-07-30,2021-07-30,ACTUAL,2021-07-30,,INTERVENTIONAL,,,A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence,A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence,COMPLETED,,PHASE2,95.0,ACTUAL,NYU Langone Health,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,OTHER,,,,,,,2021,1.0
NCT04052425,,2019-08-08,2022-07-20,2022-03-08,2022-08-25,2019-08-08,2019-08-09,ACTUAL,2022-08-25,2022-09-21,ACTUAL,2022-08-25,2022-09-21,ACTUAL,2022-08-25,2022-09-21,ACTUAL,2019-09-20,ACTUAL,2019-09-20,2022-08,2022-08-31,2021-10-21,ACTUAL,2021-10-21,2021-03-18,ACTUAL,2021-03-18,,INTERVENTIONAL,,"Baseline data are reported for members of the Safety Population, comprised of all participants who applied ruxolitinib cream or vehicle cream at least once. Treatment groups for this population were determined according to the actual treatment the participant applied on Day 1.",Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1),"Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo",COMPLETED,,PHASE3,330.0,ACTUAL,Incyte Corporation,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,INDUSTRY,,,,,,,2021,1.0
NCT03993314,,2019-06-17,2021-11-18,,2021-12-16,2019-06-17,2019-06-20,ACTUAL,2021-12-16,2021-12-17,ACTUAL,,,,2021-12-16,2021-12-17,ACTUAL,2019-08-13,ACTUAL,2019-08-13,2021-12,2021-12-31,2020-12-03,ACTUAL,2020-12-03,2020-12-03,ACTUAL,2020-12-03,,INTERVENTIONAL,,,Optimizing Anesthesia for Post Partum Tubal Ligations,Comparing 1% Spinal Chloroprocaine to Low-dose Bupivacaine Using the Epidural Volume Extension Technique for Post-Partum Tubal Ligation,TERMINATED,,PHASE2,15.0,ACTUAL,University of Alabama at Birmingham,,2.0,,Lack of recruitment due to COVID-19 pandemic; chloroprocaine shortage,f,,,,,t,f,,,t,,,,,,NO,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,OTHER,,,,,,,2020,0.0
NCT03933397,,2019-04-29,2023-05-05,,2023-06-13,2019-04-29,2019-05-01,ACTUAL,2023-06-13,2023-07-03,ACTUAL,,,,2023-06-13,2023-07-03,ACTUAL,2019-08-13,ACTUAL,2019-08-13,2023-06,2023-06-30,2022-05-20,ACTUAL,2022-05-20,2022-05-13,ACTUAL,2022-05-13,,INTERVENTIONAL,COMPARE-VOE,"Participants arrived at the emergency department and once determined that they were not COVID + and were there for a vaso-occlusive episode and bed placement occurred, baseline data were collected. Baseline data were not collected on 8 participants following bed placement. 1 withdrew consent, 2 were investigator decision, 3 confirmed COVID + and 1 did not provide baseline information.",Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease,A Comparison of Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease,TERMINATED,,PHASE3,328.0,ACTUAL,Duke University,,2.0,,Due to COVID enrollment numbers needed to meet the primary endpoint will not be met.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,OTHER,,,,,,,2022,0.0
NCT05528913,,2022-09-01,,,2024-01-04,2022-09-01,2022-09-06,ACTUAL,,,,,,,2024-01-04,2024-01-08,ACTUAL,2023-10,ESTIMATED,2023-10-31,2024-01,2024-01-31,2023-10-19,ACTUAL,2023-10-19,2023-10-19,ACTUAL,2023-10-19,,INTERVENTIONAL,,,Benralizumab in Chronic Prurigo - Investigating Clinical Efficacy (BICPIC),"A Randomized, Double-blind, Placebo-controlled, Phase 2, 12-Week Treatment Study With a 10-Week Follow-up Period to Assess the Efficacy and Safety of Benralizumab (Anti-IL5Rα) in Adult Patients With Chronic Prurigo",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Charite University, Berlin, Germany",,2.0,,Financing has been withdrawn,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,OTHER,,,,,,,2023,0.0
NCT05932979,,2023-05-12,,,2024-02-14,2023-07-03,2023-07-06,ACTUAL,,,,,,,2024-02-14,2024-02-15,ACTUAL,2023-05-02,ACTUAL,2023-05-02,2024-02,2024-02-29,2023-12-30,ESTIMATED,2023-12-30,2023-11-01,ESTIMATED,2023-11-01,,INTERVENTIONAL,L-ARGPRES,,Effect of the Administration of L-arginine vs. Placebo in Patients Diagnosed With Presbyvestibulopathy.,"Effect of the Administration of L-arginine vs. Placebo on the vHIT Result, Vestibular Caloric Tests and Symptoms of Patients Diagnosed With Presbyvestibulopathy.",WITHDRAWN,,PHASE2,0.0,ACTUAL,Centro Universitario de Tonalá,,2.0,,the investigation was cancelled because there was no monetary resource to complete it.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,OTHER,,,,,,,2023,0.0
NCT04183634,,2019-11-28,,,2020-11-05,2019-11-28,2019-12-03,ACTUAL,,,,,,,2020-11-05,2020-11-09,ACTUAL,2019-12-03,ACTUAL,2019-12-03,2020-11,2020-11-30,2020-03-16,ACTUAL,2020-03-16,2020-03-16,ACTUAL,2020-03-16,,INTERVENTIONAL,,,"An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.","An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.",TERMINATED,,PHASE1,31.0,ACTUAL,Sandoz,,2.0,,Company Decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,INDUSTRY,,,,,,,2020,0.0
NCT03049735,,2017-02-08,2022-01-03,2020-04-02,2022-03-23,2017-02-08,2017-02-10,ACTUAL,2022-03-23,2022-04-19,ACTUAL,2022-03-23,2022-04-19,ACTUAL,2022-03-23,2022-04-19,ACTUAL,2017-04-26,ACTUAL,2017-04-26,2022-03,2022-03-31,2020-08-24,ACTUAL,2020-08-24,2019-04-29,ACTUAL,2019-04-29,,INTERVENTIONAL,,All participants who were enrolled and randomized in the study.,LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids,"LIBERTY 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids",COMPLETED,,PHASE3,388.0,ACTUAL,Myovant Sciences GmbH,None reported,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2020,1.0
NCT03970330,,2019-05-15,2022-08-18,,2022-10-08,2019-05-29,2019-05-31,ACTUAL,2022-10-08,2022-11-03,ACTUAL,,,,2022-10-08,2022-11-03,ACTUAL,2020-01-16,ACTUAL,2020-01-16,2022-10,2022-10-31,2021-06-21,ACTUAL,2021-06-21,2021-06-21,ACTUAL,2021-06-21,,INTERVENTIONAL,,,Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis,A Randomized Double-Blind Placebo-Controlled Trial to Assess the Effectiveness of Low-Dose Naltrexone in Combination With Standard Treatment in Women With Chronic Pelvic Pain Secondary to Endometriosis,TERMINATED,,PHASE3,9.0,ACTUAL,Milton S. Hershey Medical Center,,2.0,,"Original PI left institution, lack of funding to continue",f,,,,t,t,f,,,,,,Data will be available one year after publication according to PMCID journal guidelines.,Data will plan to be published in a peer-reviewed journal and /or posted at clinicaltrials.gov websites or other websites per request of the NIH. Materials will also be accessible through email contact of Primary Investigator.,,YES,"Participant data will be shared that underlie the results reported in this article, after deidentification. Documents that will be available are the study protocol, statistical analysis plan, informed consent. Analyses is to achieve the study aims in the approved proposal.",2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,OTHER,,,,,,,2021,0.0
NCT02328287,,2014-12-23,,,2020-06-09,2014-12-30,2014-12-31,ESTIMATED,,,,,,,2020-06-09,2020-06-11,ACTUAL,2014-09,ACTUAL,2014-09-30,2020-06,2020-06-30,2020-04,ACTUAL,2020-04-30,2018-04,ACTUAL,2018-04-30,,INTERVENTIONAL,,,Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion,"A Pilot Phase 2a, Multicentre, Open, Proof-of-concept Study on the Safety and the Efficacy of Allogeneic Osteoblastic Cells (ALLOB®) Implantation in Rescue Interbody Fusion",TERMINATED,,PHASE2,6.0,ACTUAL,Bone Therapeutics S.A,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2020,0.0
NCT04195958,,2019-12-09,2022-01-07,,2022-02-16,2019-12-10,2019-12-12,ACTUAL,2022-02-16,2022-03-15,ACTUAL,,,,2022-02-16,2022-03-15,ACTUAL,2020-11-30,ACTUAL,2020-11-30,2022-02,2022-02-28,2021-10-18,ACTUAL,2021-10-18,2021-10-18,ACTUAL,2021-10-18,,INTERVENTIONAL,EDURO,"This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.","A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma","A Multicenter, Open-Label, Single-Arm Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Patients With Moderate to Severe Allergic Asthma",TERMINATED,,PHASE4,3.0,ACTUAL,"Genentech, Inc.","This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on this, there were not enough participants enrolled to perform a meaningful analysis.",1.0,,"Due to low enrollment, this study was terminated early.",f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).~For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 01:55:18.907458,2024-10-16 01:55:18.907458,INDUSTRY,,,,,,,2021,0.0
NCT02677896,,2016-02-05,2020-01-08,2019-10-01,2024-08-13,2016-02-05,2016-02-09,ESTIMATED,2020-01-08,2020-01-21,ACTUAL,2019-10-01,2019-10-09,ACTUAL,2024-08-13,2024-09-04,ACTUAL,2016-03-09,ACTUAL,2016-03-09,2024-08,2024-08-31,2024-07-31,ACTUAL,2024-07-31,2018-10-14,ACTUAL,2018-10-14,,INTERVENTIONAL,ARCHES,All Randomized Participants,A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC),"A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)",COMPLETED,,PHASE3,1150.0,ACTUAL,Astellas Pharma Inc,,3.0,,,f,,,,t,t,f,,,,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://www.clinicalstudydatarequest.com/,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,INDUSTRY,,,,,,,2024,1.0
NCT04481191,,2020-07-20,2023-01-23,2022-03-29,2024-07-18,2020-07-20,2020-07-22,ACTUAL,2023-01-23,2023-02-17,ACTUAL,2022-03-29,2022-03-31,ACTUAL,2024-07-18,2024-07-26,ACTUAL,2020-08-25,ACTUAL,2020-08-25,2024-07,2024-07-31,2021-05-08,ACTUAL,2021-05-08,2021-05-08,ACTUAL,2021-05-08,,INTERVENTIONAL,,,Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074),"A Phase 3 Randomized, Open-Label, Clinical Trial to Study the Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of V260 and Inactivated Poliomyelitis Vaccine (IPV) in Chinese Healthy Infants",COMPLETED,,PHASE3,400.0,ACTUAL,Merck Sharp & Dohme LLC,Protocol Amendment 3 was issued after study completion. The purpose of the amendment was to update the Sponsor entity name and address.,2.0,,,f,,,,f,t,f,,,t,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,INDUSTRY,,,,,,,2021,1.0
NCT04233034,,2020-01-14,,,2022-10-31,2020-01-15,2020-01-18,ACTUAL,,,,,,,2022-10-31,2022-11-03,ACTUAL,2020-07-09,ACTUAL,2020-07-09,2022-10,2022-10-31,2022-09-30,ACTUAL,2022-09-30,2022-09-15,ACTUAL,2022-09-15,,INTERVENTIONAL,CLVer,,Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes,Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer),COMPLETED,,PHASE3,113.0,ACTUAL,Jaeb Center for Health Research,,4.0,,,f,,,,t,t,t,t,,,,,,,,,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,OTHER,,,,,,,2022,1.0
NCT04665310,,2019-04-02,,,2020-12-10,2020-12-10,2020-12-11,ACTUAL,,,,,,,2020-12-10,2020-12-11,ACTUAL,2018-09-01,ACTUAL,2018-09-01,2020-12,2020-12-31,2022-10-31,ESTIMATED,2022-10-31,2020-10-31,ESTIMATED,2020-10-31,,INTERVENTIONAL,,,"Evaluation of Anti-rejection Drug, Tacrolimus, in African-Americans With Kidney Transplant",Evaluation of Early Dose Escalation Using Extended-Release Tacrolimus (Envarsus XR®) to Reduce Acute Rejection and Donor Specific Antibodies in African American Renal Transplant Recipients,WITHDRAWN,,PHASE4,0.0,ACTUAL,The Methodist Hospital Research Institute,,6.0,,"Study not started, funding",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,OTHER,,,,,,,2022,0.0
NCT02992886,,2016-11-30,,,2021-09-01,2016-12-13,2016-12-14,ESTIMATED,,,,,,,2021-09-01,2021-09-09,ACTUAL,2016-09,,2016-09-30,2021-09,2021-09-30,2021-08,ACTUAL,2021-08-31,2021-05,ACTUAL,2021-05-31,,INTERVENTIONAL,,,Preoperative Chemoradiotherapy With Raltitrexed for Intermediate or Locally Advanced Rectal Cancer in the Fit Elderly,"Multicenter, Phase II Study of Preoperative Chemoradiotherapy With Raltitrexed for Intermediate or Locally Advanced Rectal Cancer in the Fit Elderly",COMPLETED,,PHASE2,68.0,ACTUAL,ChineseAMS,,1.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 02:01:05.709567,2024-10-16 02:01:05.709567,UNKNOWN,,,,,,,2021,1.0
NCT04853368,,2021-04-19,2024-06-03,,2024-07-15,2021-04-19,2021-04-21,ACTUAL,2024-07-15,2024-07-16,ACTUAL,,,,2024-07-15,2024-07-16,ACTUAL,2021-09-20,ACTUAL,2021-09-20,2024-07,2024-07-31,2023-06-05,ACTUAL,2023-06-05,2023-06-05,ACTUAL,2023-06-05,,INTERVENTIONAL,,The Full Analysis Set (FAS) includes all enrolled subjects (randomized subjects for Cohort 2) who received at least 1 dose of study drug as dual or triple combination (or corresponding placebo). The FAS was used for demographics and baseline characteristics analyses.,Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Adult Participants With Cystic Fibrosis,A Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation,TERMINATED,,PHASE2,48.0,ACTUAL,AbbVie,,4.0,,Strategic considerations,f,,,,t,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,INDUSTRY,,,,,,,2023,0.0
NCT03708926,,2018-10-09,,,2021-04-07,2018-10-16,2018-10-17,ACTUAL,,,,,,,2021-04-07,2021-04-12,ACTUAL,2021-03,ESTIMATED,2021-03-31,2020-05,2020-05-31,2024-02,ESTIMATED,2024-02-29,2023-08,ESTIMATED,2023-08-31,,INTERVENTIONAL,,,Effect of Abaloparatide on Lumbar Disc Degeneration,Effect of Abaloparatide on Lumbar Disc Degeneration,WITHDRAWN,,PHASE2,0.0,ACTUAL,Johns Hopkins University,,2.0,,Inability to obtain drugs from supplier.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,OTHER,,,,,,,2024,0.0
NCT04731740,,2021-01-26,,,2024-03-21,2021-01-26,2021-02-01,ACTUAL,,,,,,,2024-03-21,2024-03-25,ACTUAL,2020-12-28,ACTUAL,2020-12-28,2024-03,2024-03-31,2023-12-28,ACTUAL,2023-12-28,2023-12-28,ACTUAL,2023-12-28,,INTERVENTIONAL,,,Pembrolizumab and Lenvatinib/Chemotherapy for Poorly Differentiated/Anaplastic Thyroid Cancer,Pembrolizumab in Combination With Standard 1st Line Therapy (Lenvatinib / Chemotherapy) for Locally Advanced or Metastatic Poorly Differentiated or Anaplastic Thyroid Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Saint Petersburg State University, Russia",,2.0,,Lack of funding,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,OTHER,,,,,,,2023,0.0
NCT03872388,,2019-03-11,2024-08-07,,2024-09-09,2019-03-11,2019-03-13,ACTUAL,2024-09-09,2024-10-02,ACTUAL,,,,2024-09-09,2024-10-02,ACTUAL,2019-09-23,ACTUAL,2019-09-23,2024-09,2024-09-30,2023-10-19,ACTUAL,2023-10-19,2023-10-19,ACTUAL,2023-10-19,,INTERVENTIONAL,,6 participants were accrued and assessed for eligibility and 4 patients were assigned to the cohort.,Atorvastatin in Treating Patients With Stage IIb-III Triple Negative Breast Cancer Who Did Not Achieve a Pathologic Complete Response After Receiving Neoadjuvant Chemotherapy,"Atorvastatin in Triple-Negative Breast Cancer (TNBC) Patients Who Did Not Achieve a Pathologic Complete Response (pCR) After Receiving Neoadjuvant Chemotherapy, a Multicenter Pilot Study",TERMINATED,,PHASE2,6.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,Due to slow accrual,f,,,,f,t,f,,,,,,,,,,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,OTHER,,,,,,,2023,0.0
NCT04822701,,2021-03-29,2022-06-28,,2022-07-25,2021-03-29,2021-03-30,ACTUAL,2022-06-28,2022-07-21,ACTUAL,,,,2022-07-25,2022-07-28,ACTUAL,2021-04-21,ACTUAL,2021-04-21,2022-07,2022-07-31,2021-10-04,ACTUAL,2021-10-04,2021-07-02,ACTUAL,2021-07-02,,INTERVENTIONAL,,Treated set (TS): This subject set includes all subjects who received any amount of study drug.,A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19,"A Phase II/III Seamless, Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential Study to Evaluate Efficacy, Safety and Tolerability of BI 767551 for the Treatment of Symptomatic, Non-hospitalized Adults With Mild to Moderate COVID-19.",TERMINATED,,PHASE2/PHASE3,5.0,ACTUAL,Boehringer Ingelheim,This trial was prematurely discontinued due to sponsor decision. 4 participants were enrolled in the Phase II Placebo intravenous (i.v.) + placebo inhaled group and 1 participant in the Placebo intravenous (i.v.) + BI 250 mg inhaled group. No patients were entered in the planned Phase II BI 10 milligrams (mg)/kilogram (kg) intravenous (i.v.) + placebo inhaled and BI 40 mg/kg i.v. + placebo inhaled groups. Phase III part was not conducted.,6.0,,not due to safety reasons,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the United States (US) and European Union (EU) for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,INDUSTRY,,,,,,,2021,0.0
NCT02144142,,2014-05-19,,,2020-11-03,2014-05-19,2014-05-21,ESTIMATED,,,,,,,2020-11-03,2020-11-05,ACTUAL,2015-07,,2015-07-31,2020-11,2020-11-30,2022-07,ESTIMATED,2022-07-31,2022-07,ESTIMATED,2022-07-31,,INTERVENTIONAL,,,Evaluation of the Kinetic Properties of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients,Phase 2 Study Evaluating the Kinetic Properties of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, San Diego",,1.0,,This sub-study was not done because main study results reached significance.,f,,,,f,,,,,,,,,,,,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2022,0.0
NCT04618263,,2020-10-31,,,2022-08-01,2020-10-31,2020-11-05,ACTUAL,,,,,,,2022-08-01,2022-08-03,ACTUAL,2020-10-26,ACTUAL,2020-10-26,2022-08,2022-08-31,2021-08-13,ACTUAL,2021-08-13,2021-08-13,ACTUAL,2021-08-13,,INTERVENTIONAL,,,Safety and Tolerability of Single and Multiple Ascending Doses of GATE-101 in Normal Human Volunteers,"A Randomized Double-blind, Placebo-controlled Single and Multiple Intravenous Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of GATE-101 in Normal Healthy Volunteers",TERMINATED,,PHASE1,18.0,ACTUAL,"Gate Neurosciences, Inc",,12.0,,Reached biomarker endpoint,f,,,,f,t,f,,,,,,,,,,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,INDUSTRY,,,,,,,2021,0.0
NCT04524663,,2020-04-10,2022-05-13,,2022-06-09,2020-08-20,2020-08-24,ACTUAL,2022-06-09,2022-06-10,ACTUAL,,,,2022-06-09,2022-06-10,ACTUAL,2020-12-19,ACTUAL,2020-12-19,2022-06,2022-06-30,2021-05-15,ACTUAL,2021-05-15,2021-05-15,ACTUAL,2021-05-15,,INTERVENTIONAL,COPS-2003,,Oral Camostat Compared With Standard Supportive Care in Mild-Moderate COVID-19 Patients,"A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Camostat Mesilate Compared to Standard of Care in Subjects With Mild-Moderate COVID-19",COMPLETED,,PHASE2,49.0,ACTUAL,Stanford University,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,OTHER,,,,,,,2021,1.0
NCT04235959,,2020-01-20,2022-08-11,,2022-08-11,2020-01-20,2020-01-22,ACTUAL,2022-08-11,2023-07-06,ACTUAL,,,,2022-08-11,2023-07-06,ACTUAL,2020-10-21,ACTUAL,2020-10-21,2022-08,2022-08-31,2021-08-17,ACTUAL,2021-08-17,2021-08-17,ACTUAL,2021-08-17,,INTERVENTIONAL,,All participants who received at least one dose of study drug.,A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus,"A Multiple Dose Titration Study in Chinese Patients With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Tirzepatide",COMPLETED,,PHASE1,24.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,INDUSTRY,,,,,,,2021,1.0
NCT04640168,,2020-11-19,2022-04-14,,2022-06-22,2020-11-19,2020-11-23,ACTUAL,2022-06-22,2022-06-28,ACTUAL,,,,2022-06-22,2022-06-28,ACTUAL,2020-12-02,ACTUAL,2020-12-02,2021-04,2021-04-30,2021-06-18,ACTUAL,2021-06-18,2021-05-18,ACTUAL,2021-05-18,,INTERVENTIONAL,,The population includes all participants enrolled.,Adaptive COVID-19 Treatment Trial 4 (ACTT-4),"A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTT-4)",COMPLETED,,PHASE3,1010.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,NIH,,,,,,,2021,1.0
NCT04416906,,2020-06-02,,,2023-09-15,2020-06-02,2020-06-04,ACTUAL,,,,,,,2023-09-15,2023-09-18,ACTUAL,2020-10-05,ACTUAL,2020-10-05,2023-09,2023-09-30,2023-05-11,ACTUAL,2023-05-11,2023-05-11,ACTUAL,2023-05-11,,INTERVENTIONAL,Test&Treat,,A Test and Treat Strategy in New HIV Diagnosis.,A Test and Treat Strategy in Barcelona: A Prospective Study in New HIV Diagnosis.,COMPLETED,,PHASE3,100.0,ACTUAL,Fundacion Clinic per a la Recerca Biomédica,,1.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,A plan description will be provided once it is decided,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,OTHER,,,,,,,2023,1.0
NCT03514407,,2018-04-20,,,2020-07-14,2018-04-20,2018-05-02,ACTUAL,,,,,,,2020-07-14,2020-07-16,ACTUAL,2018-06-27,ACTUAL,2018-06-27,2020-07,2020-07-31,2020-06-25,ACTUAL,2020-06-25,2020-06-25,ACTUAL,2020-06-25,,INTERVENTIONAL,,,A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma,"An Open-Label Phase 1b Study of the Safety, Tolerability, and Preliminary Antitumor Activity of INCB059872 in Participants With Relapsed or Refractory Ewing Sarcoma",TERMINATED,,PHASE1,25.0,ACTUAL,Incyte Corporation,,1.0,,Strategic Business Decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 15:24:52.208295,2024-10-15 15:24:52.208295,INDUSTRY,,,,,,,2020,0.0
NCT02369874,,2015-02-18,2019-09-10,,2021-01-21,2015-02-23,2015-02-24,ESTIMATED,2019-09-10,2019-10-03,ACTUAL,,,,2021-01-21,2021-02-10,ACTUAL,2015-09-09,ACTUAL,2015-09-09,2021-01,2021-01-31,2020-11-13,ACTUAL,2020-11-13,2018-09-10,ACTUAL,2018-09-10,,INTERVENTIONAL,EAGLE,,Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer,"A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy and MEDI4736 in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)",COMPLETED,,PHASE3,736.0,ACTUAL,AstraZeneca,Multiple testing was performed for OS analysis in the intent-to-treat (ITT) population and OS analysis in the PD-L1 negative population for durvalumab + tremelimumab versus SoC only.,3.0,,,f,,,,t,,,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,INDUSTRY,,,,,,,2020,1.0
NCT04290871,,2020-02-27,,,2023-02-05,2020-02-27,2020-03-02,ACTUAL,,,,,,,2023-02-05,2023-02-08,ACTUAL,2023-01-16,ESTIMATED,2023-01-16,2023-02,2023-02-28,2024-04-01,ESTIMATED,2024-04-01,2023-12-31,ESTIMATED,2023-12-31,,INTERVENTIONAL,NOSARSCOVID,,Nitric Oxide Gas Inhalation for Severe Acute Respiratory Syndrome in COVID-19.,Nitric Oxide Gas Inhalation Therapy for Severe Acute Respiratory Syndrome Due to COVID-19.,WITHDRAWN,,PHASE2,0.0,ACTUAL,Xijing Hospital,,2.0,,The study will start to enroll patients soon,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,OTHER,,,,,,,2024,0.0
NCT03841331,,2019-02-12,2020-08-13,,2021-05-18,2019-02-12,2019-02-15,ACTUAL,2020-09-02,2020-09-23,ACTUAL,,,,2021-05-18,2021-05-20,ACTUAL,2019-01-22,ACTUAL,2019-01-22,2021-05,2021-05-31,2020-01-21,ACTUAL,2020-01-21,2019-12-10,ACTUAL,2019-12-10,,INTERVENTIONAL,,,"Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin","A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin",COMPLETED,,PHASE2,233.0,ACTUAL,Vyne Therapeutics Inc.,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,INDUSTRY,,,,,,,2020,1.0
NCT03703908,,2018-07-24,2022-08-10,,2024-01-10,2018-10-09,2018-10-12,ACTUAL,2024-01-10,2024-02-06,ACTUAL,,,,2024-01-10,2024-02-06,ACTUAL,2018-10-01,ACTUAL,2018-10-01,2024-01,2024-01-31,2020-06-24,ACTUAL,2020-06-24,2020-06-24,ACTUAL,2020-06-24,,INTERVENTIONAL,,,A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome,"An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome",TERMINATED,,PHASE2,5.0,ACTUAL,ChemoCentryx,"The CL012_140 study was terminated early due to lack of efficacy in another study, CL011_140, investigating the use of CCX140-B.",1.0,,Program not advancing,f,,,,f,t,f,,,,,,,,,,,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,INDUSTRY,,,,,,,2020,0.0
NCT04973527,,2021-07-07,,,2022-08-12,2021-07-21,2021-07-22,ACTUAL,,,,,,,2022-08-12,2022-08-16,ACTUAL,2021-07-02,ACTUAL,2021-07-02,2022-08,2022-08-31,2022-07-20,ACTUAL,2022-07-20,2022-07-11,ACTUAL,2022-07-11,,INTERVENTIONAL,,,LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T Lymphocyte Tumor,"A Phase I, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T Lymphocyte Tumor Patients",TERMINATED,,PHASE1,9.0,ACTUAL,Beijing Boren Hospital,,1.0,,Both the sponsors and collaborator are considering terminating the study,f,,,,,f,f,,,,,,,,,,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,OTHER,,,,,,,2022,0.0
NCT03938857,,2019-04-25,2021-09-02,,2021-10-07,2019-05-02,2019-05-06,ACTUAL,2021-10-07,2021-11-05,ACTUAL,,,,2021-10-07,2021-11-05,ACTUAL,2019-07-18,ACTUAL,2019-07-18,2021-10,2021-10-31,2020-11-06,ACTUAL,2020-11-06,2020-10-21,ACTUAL,2020-10-21,,INTERVENTIONAL,DOSE,Study was prematurely terminated and no participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group.,DOSE Trial of Opioid Sparing Effect,"DEXMEDETOMIDINE OPIOID SPARING EFFECT IN MECHANICALLY VENTILATED CHILDREN: Phase 1b, Multicenter, Double Blind Randomized Controlled Dose Escalating Trial of Fentanyl vs. Fentanyl + Dexmedetomidine as the Initial Regimen for Maintenance of Sedation in Mechanically-ventilated, Critically Ill Children",TERMINATED,,PHASE1,30.0,ACTUAL,Duke University,,4.0,,Enrollment challenging during the pandemic COVID 19,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,OTHER,,,,,,,2020,0.0
NCT03427320,,2017-12-20,,,2022-07-07,2018-02-02,2018-02-09,ACTUAL,,,,,,,2022-07-07,2022-07-11,ACTUAL,2018-12,ESTIMATED,2018-12-31,2018-02,2018-02-28,2021-04,ESTIMATED,2021-04-30,2021-04,ESTIMATED,2021-04-30,,INTERVENTIONAL,,,Imaging of Advanced Tumours Using [131]I-IAZA,A Radiopharmacokinetic and Radiodosimetric Phase I/II Imaging Study of 1-alpha-D-(5-[131I]Iodo-5-deoxyarabinofuranosyl)-2-Nitroimidazole (131I-IAZA) in Patients With Locally Advanced or Metastatic Solid Tumors,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Alberta,,1.0,,Abandoned.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,OTHER,,,,,,,2021,0.0
NCT03445663,,2018-02-01,,,2023-03-03,2018-02-20,2018-02-26,ACTUAL,,,,,,,2023-03-03,2023-03-07,ACTUAL,2018-07-31,ACTUAL,2018-07-31,2023-03,2023-03-31,2020-06-19,ACTUAL,2020-06-19,2020-06-19,ACTUAL,2020-06-19,,INTERVENTIONAL,,,Study Evaluating AMG 424 in Subjects With Multiple Myeloma,"A Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 424 in Subjects With Multiple Myeloma",TERMINATED,,PHASE1,27.0,ACTUAL,"Xencor, Inc.",,1.0,,Previous sponsor business decision not to proceed with the AMG 424 asset.,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,INDUSTRY,,,,,,,2020,0.0
NCT03907033,,2019-04-05,2021-09-20,,2021-09-20,2019-04-05,2019-04-08,ACTUAL,2021-09-20,2021-10-15,ACTUAL,,,,2021-09-20,2021-10-15,ACTUAL,2019-09-03,ACTUAL,2019-09-03,2021-09,2021-09-30,2021-07-23,ACTUAL,2021-07-23,2021-07-23,ACTUAL,2021-07-23,,INTERVENTIONAL,,,Liposomal Bupivacaine in Vaginal Hysterectomy,Preemptive Local Analgesia With Liposomal Bupivacaine in Vaginal Hysterectomy: A Randomized Controlled Study,TERMINATED,,PHASE4,28.0,ACTUAL,Mayo Clinic,,2.0,,Insufficient funding to continue with study activities,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,OTHER,,,,,,,2021,0.0
NCT04842981,,2021-03-23,,,2023-01-20,2021-04-10,2021-04-13,ACTUAL,,,,,,,2023-01-20,2023-01-25,ACTUAL,2021-05-25,ACTUAL,2021-05-25,2023-01,2023-01-31,2022-09-30,ACTUAL,2022-09-30,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,,,Interleukin-6 Inhibitors and Drug-drug Interactions in Patients With Rheumatoid Arthritis,Interleukin-6 Inhibitors and Drug-drug Interactions in Patients With Rheumatoid Arthritis,TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,University of Southern Denmark,,1.0,,Slow recruitment due to COVID19.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,OTHER,,,,,,,2022,0.0
NCT03488225,,2018-03-29,2021-01-28,,2024-07-03,2018-03-29,2018-04-04,ACTUAL,2021-03-18,2021-04-13,ACTUAL,,,,2024-07-03,2024-07-16,ACTUAL,2018-03-28,ACTUAL,2018-03-28,2024-07,2024-07-31,2020-04-02,ACTUAL,2020-04-02,2020-04-02,ACTUAL,2020-04-02,,INTERVENTIONAL,,,Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblastic Leukemia,Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia,TERMINATED,,PHASE2,4.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,the study was closed early due to competing trials,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,OTHER,,,,,,,2020,0.0
NCT03620890,,2018-08-02,2021-07-23,,2021-08-20,2018-08-02,2018-08-08,ACTUAL,2021-07-23,2021-08-18,ACTUAL,,,,2021-08-20,2021-09-16,ACTUAL,2018-09-04,ACTUAL,2018-09-04,2021-08,2021-08-31,2020-07-29,ACTUAL,2020-07-29,2020-07-29,ACTUAL,2020-07-29,,INTERVENTIONAL,Determin,,Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy,"Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy: a Comparative-effectiveness, Open Label, Randomized Controlled Trial",COMPLETED,,PHASE4,108.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2020,0.0
NCT04256603,,2020-02-01,2021-06-16,,2021-11-11,2020-02-04,2020-02-05,ACTUAL,2021-11-11,2021-11-15,ACTUAL,,,,2021-11-11,2021-11-15,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2021-11,2021-11-30,2020-04-01,ACTUAL,2020-04-01,2020-03-30,ACTUAL,2020-03-30,,INTERVENTIONAL,,,Evaluation of Initiation Time on the Efficacy of Gabapentin in Treating Neuropathic Pain in SCI,Evaluation of Initiation Time on the Efficacy of Gabapentin in Treating Neuropathic Pain in Spinal Cord Injury (SCI),COMPLETED,,PHASE4,27.0,ACTUAL,MetroHealth Medical Center,,3.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 02:01:05.709567,2024-10-16 02:01:05.709567,OTHER,,,,,,,2020,1.0
NCT01524783,,2011-12-22,2016-03-26,,2021-07-13,2012-02-01,2012-02-02,ESTIMATED,2016-11-01,2016-12-28,ESTIMATED,,,,2021-07-13,2021-08-05,ACTUAL,2012-03-30,ACTUAL,2012-03-30,2021-07,2021-07-31,2020-08-07,ACTUAL,2020-08-07,2014-11-28,ACTUAL,2014-11-28,,INTERVENTIONAL,RADIANT-4,,Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin),"A Randomized, Double-blind, Multicenter, Phase III Study of Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced NET of GI or Lung Origin",COMPLETED,,PHASE3,302.0,ACTUAL,Novartis,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,INDUSTRY,,,,,,,2020,1.0
NCT04988035,,2021-07-29,2023-04-13,,2023-06-06,2021-07-29,2021-08-03,ACTUAL,2023-06-06,2023-06-08,ACTUAL,,,,2023-06-06,2023-06-08,ACTUAL,2021-08-03,ACTUAL,2021-08-03,2021-07,2021-07-31,2022-04-23,ACTUAL,2022-04-23,2022-04-23,ACTUAL,2022-04-23,,INTERVENTIONAL,,The intention-to-treat (ITT) population includes all participants who were enrolled and randomized.,ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19,A Multicenter Platform Trial of Putative Therapeutics for the Treatment of COVID-19 in Hospitalized Adults,COMPLETED,,PHASE2,201.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,4.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,NIH,,,,,,,2022,1.0
NCT02117466,,2014-04-08,,,2021-04-08,2014-04-17,2014-04-21,ESTIMATED,,,,,,,2021-04-08,2021-04-14,ACTUAL,2014-04,,2014-04-30,2021-04,2021-04-30,2021-01,ACTUAL,2021-01-31,2021-01,ACTUAL,2021-01-31,,INTERVENTIONAL,IMPACT-CRC,,Image Guided Treatment Optimization With Cetuximab for Patients With Metastatic Colorectal Cancer,Image Guided Treatment Optimization With Cetuximab for Patients With Metastatic Colorectal Cancer,TERMINATED,,PHASE1/PHASE2,85.0,ACTUAL,"Amsterdam UMC, location VUmc",,2.0,,Primary endpoint could no longer be reached.,f,,,,t,,,,,,,,,,,,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,OTHER,,,,,,,2021,0.0
NCT04291456,,2019-11-18,,,2023-03-22,2020-02-27,2020-03-02,ACTUAL,,,,,,,2023-03-22,2023-03-24,ACTUAL,2020-01-31,ACTUAL,2020-01-31,2023-03,2023-03-31,2022-12-31,ACTUAL,2022-12-31,2022-12-16,ACTUAL,2022-12-16,,INTERVENTIONAL,MS,,Minocycline in MS: Confirmation of Benefit,Open-Label Trial of Minocycline in Early Multiple Sclerosis: Confirmation of Treatment Benefit,TERMINATED,,PHASE3,9.0,ACTUAL,University of Calgary,,1.0,,Completion is not possible due to recruitment concerns,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,OTHER,,,,,,,2022,0.0
NCT05351047,,2022-04-01,,,2023-08-04,2022-04-22,2022-04-28,ACTUAL,,,,,,,2023-08-04,2023-08-07,ACTUAL,2022-04-04,ACTUAL,2022-04-04,2023-08,2023-08-31,2023-07-06,ACTUAL,2023-07-06,2023-07-06,ACTUAL,2023-07-06,,INTERVENTIONAL,,,"A Study to Assess Safety, Tolerability, PK and PD of AZD2373 in Healthy Male Participants of Sub-Saharan West African Ancestry","A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2373 Following Multiple Ascending Dose Administration to Healthy Male Participants of Sub-Saharan West African Ancestry",COMPLETED,,PHASE1,24.0,ACTUAL,AstraZeneca,,5.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 02:01:05.709567,2024-10-16 02:01:05.709567,INDUSTRY,,,,,,,2023,1.0
NCT01462890,,2011-10-25,,,2022-07-19,2011-10-28,2011-11-01,ESTIMATED,,,,,,,2022-07-19,2022-07-20,ACTUAL,2011-11,ACTUAL,2011-11-30,2022-07,2022-07-31,2021-12,ACTUAL,2021-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,BOOST,,Evaluation of Optimal Treatment Duration of Bevacizumab Combination With Standard Chemotherapy in Patients With Ovarian Cancer,"A Prospective Randomised Phase III Trial to Evaluate Optimal Treatment Duration of First-line Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Primary Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer",COMPLETED,,PHASE3,927.0,ACTUAL,AGO Study Group,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,OTHER,,,,,,,2021,0.0
NCT03912818,,2019-04-08,2023-08-15,,2023-08-15,2019-04-09,2019-04-11,ACTUAL,2023-08-15,2023-09-11,ACTUAL,,,,2023-08-15,2023-09-11,ACTUAL,2019-04-10,ACTUAL,2019-04-10,2023-08,2023-08-31,2022-08-11,ACTUAL,2022-08-11,2022-08-11,ACTUAL,2022-08-11,,INTERVENTIONAL,,,Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology Bladder Cancer,Phase 2 Open Label Study of Durvalumab With Neoadjuvant Chemotherapy in Variant Histology Bladder Cancer,TERMINATED,,PHASE2,7.0,ACTUAL,Stanford University,The study did not achieve its planned enrollment size and did not achieve statistical power.,3.0,,Difficulty with enrollment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,OTHER,,,,,,,2022,0.0
NCT04311567,,2020-03-05,,,2024-05-21,2020-03-15,2020-03-17,ACTUAL,,,,,,,2024-05-21,2024-05-23,ACTUAL,2020-11-07,ACTUAL,2020-11-07,2022-04,2022-04-30,2024-03-26,ACTUAL,2024-03-26,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,PULMORA,,Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease,"Effects of Tofacitinib vs Methotrexate on Clinical and Molecular Disease Activity Markers in Joints and Lungs in Early Rheumatoid Arthritis (PULMORA) - A Randomized, Controlled, Open-label, Assessor-blinded, Phase IV Trial",TERMINATED,,PHASE4,3.0,ACTUAL,Vastra Gotaland Region,,2.0,,Low recruitment due to the pandemic and high screening failure rate in particular because of low prevalence of interstitial abnormalities at diagnosis in Sweden.,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 02:01:05.709567,2024-10-16 02:01:05.709567,OTHER_GOV,,,,,,,2024,0.0
NCT04578886,,2020-09-18,2024-02-06,,2024-06-29,2020-10-06,2020-10-08,ACTUAL,2024-04-16,2024-04-17,ACTUAL,,,,2024-06-29,2024-07-25,ACTUAL,2020-11-23,ACTUAL,2020-11-23,2024-06,2024-06-30,2023-04-01,ACTUAL,2023-04-01,2023-02-20,ACTUAL,2023-02-20,,INTERVENTIONAL,,Patients admitted to surgical intensive care units at the University of Alabama at Birmingham Hospital.,The Effect of Guanfacine on Delirium in Critically Ill Patients,The Effect of Guanfacine on Delirium in Critically Ill Patients,COMPLETED,,PHASE3,100.0,ACTUAL,University of Alabama at Birmingham,This study is limited by the nature of being a single center design with a small sample size. The study population is in the critically ill surgical patient and this acuity and demographic may limit the external validity.,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 02:01:05.709567,2024-10-16 02:01:05.709567,OTHER,,,,,,,2023,1.0
NCT02678455,,2016-02-05,,,2020-08-04,2016-02-05,2016-02-09,ESTIMATED,,,,,,,2020-08-04,2020-08-06,ACTUAL,2016-03,,2016-03-31,2020-08,2020-08-31,2020-02-05,ACTUAL,2020-02-05,2017-08-10,ACTUAL,2017-08-10,,INTERVENTIONAL,,,"Safety and Immunogenicity of the Dengue Virus Vaccine TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh","Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Immunogenicity of the Recombinant Live Attenuated Tetravalent Dengue Virus Vaccine Admixture TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh",COMPLETED,,PHASE2,192.0,ESTIMATED,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,NIH,,,,,,,2020,1.0
NCT03173859,,2017-05-28,,,2020-11-15,2017-05-31,2017-06-02,ACTUAL,,,,,,,2020-11-15,2020-11-18,ACTUAL,2018-01,ESTIMATED,2018-01-31,2020-11,2020-11-30,2020-12-31,ESTIMATED,2020-12-31,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,AERA,,Efficacy of Rotations Between Abiraterone Acetate and Apalutamide in mCRPC Patients,A Randomized Phase II Study to Investigate the Efficacy of Rotations Between Abiraterone Acetate and Apalutamide Versus Sequential Administration in Chemo-naïve Metastatic Castration Resistant Prostate Cancer Patients,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Athens,,2.0,,Delayed initiation,f,,,,,f,f,,,f,,,,,,NO,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2020,0.0
NCT03478982,,2018-03-07,2020-12-16,,2021-02-02,2018-03-20,2018-03-27,ACTUAL,2021-02-02,2021-02-03,ACTUAL,,,,2021-02-02,2021-02-03,ACTUAL,2018-03-16,ACTUAL,2018-03-16,2021-02,2021-02-28,2020-01-04,ACTUAL,2020-01-04,2019-12-22,ACTUAL,2019-12-22,,INTERVENTIONAL,StATES,Baseline Characteristics refers to Intent-to-treat (ITT) population. ITT population included all participants who had a seizure event and received study drug during the Treatment Period.,"Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern","A Double-Blind, Placebo-Controlled, Inpatient, Dose-Ranging Efficacy Study of Staccato Alprazolam (STAP-001) in Subjects With Epilepsy With a Predictable Seizure Pattern",COMPLETED,,PHASE2,156.0,ACTUAL,UCB Pharma,,3.0,,,f,,,,f,t,f,,,,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",http://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,INDUSTRY,,,,,,,2020,1.0
NCT04959266,,2021-06-08,,,2022-09-15,2021-06-30,2021-07-13,ACTUAL,,,,,,,2022-09-15,2022-09-16,ACTUAL,2021-06-28,ACTUAL,2021-06-28,2022-08,2022-08-31,2022-06-01,ACTUAL,2022-06-01,2022-06-01,ACTUAL,2022-06-01,,INTERVENTIONAL,,,"A Study to Assess the Effects of Itraconazole, Rifampicin, and Omeprazole on Pharmacokinetics of Adavosertib","A Phase I, Open-label, Non-randomised Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor), Rifampicin (a CYP3A4 Inducer), and Omeprazole (a Proton Pump Inhibitor) on the Pharmacokinetics of a Single Oral Dose of Adavosertib in Patients With Advanced Solid Tumours",TERMINATED,,PHASE1,5.0,ACTUAL,AstraZeneca,,3.0,,The study terminated because the clinical development programme for Adavosertib has been discontinued,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the~Disclosure Statements at:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,INDUSTRY,,,,,,,2022,0.0
NCT04746495,,2021-01-12,,,2023-02-16,2021-02-05,2021-02-09,ACTUAL,,,,,,,2023-02-16,2023-02-21,ACTUAL,2023-02,ESTIMATED,2023-02-28,2023-02,2023-02-28,2023-12-01,ESTIMATED,2023-12-01,2023-07-01,ESTIMATED,2023-07-01,,INTERVENTIONAL,ENOVA,,Effect of Eplerenone on Novel Biomarkers of Mineralocorticoid Receptor Activation (ENOVA),Effect of Eplerenone on Novel Biomarkers of Mineralocorticoid Receptor Activation (ENOVA),WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Michigan,,2.0,,"Issues relate to COVID-19 and staffing challenges, as well as very tight finances.",f,,,,t,t,f,,,f,,,De-identified data will be deposited into a repository within 1 year of the conclusion of the study.,"No additional access restrictions will be placed on the de-identified data, beyond those required by the repository to access or download the data.",,YES,"We will de-identify participant information and will share it with a trusted repository, such as National Institutes of Health (NIH) Figshare or The Inter-university Consortium for Political and Social Research (ICPSR).~We will de-identify and share data obtained from analyzing urinary mRNA biomarkers and measuring the systolic and diastolic blood pressure following consumption of a high-sodium and low-sodium diet. Additionally, specific lab values that support the validity and quality of the study treatment will be shared in a trusted repository.",2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,OTHER,,,,,,,2023,0.0
NCT02829723,,2016-07-08,2023-11-15,,2023-12-21,2016-07-08,2016-07-12,ESTIMATED,2023-12-21,2024-01-18,ACTUAL,,,,2023-12-21,2024-01-18,ACTUAL,2016-10-21,ACTUAL,2016-10-21,2023-12,2023-12-31,2022-12-01,ACTUAL,2022-12-01,2022-12-01,ACTUAL,2022-12-01,,INTERVENTIONAL,,Full Analysis Set,A Study of BLZ945 Single Agent or BLZ945 in Combination With PDR001 in Advanced Solid Tumors,"A Phase I/II, Open-label, Multi-center Study of the Safety and Efficacy of BLZ945 as Single Agent and in Combination With PDR001 in Adults Patients With Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,192.0,ACTUAL,Novartis,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,INDUSTRY,,,,,,,2022,0.0
NCT04983589,,2021-07-22,2023-02-06,,2023-03-17,2021-07-22,2021-07-30,ACTUAL,2023-03-17,2023-03-21,ACTUAL,,,,2023-03-17,2023-03-21,ACTUAL,2021-09-02,ACTUAL,2021-09-02,2023-03,2023-03-31,2022-02-11,ACTUAL,2022-02-11,2022-02-11,ACTUAL,2022-02-11,,INTERVENTIONAL,Virgo,Intent-to-treat (ITT) Population included all randomized participants.,A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily,"A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of BID Dosing of AGN-190584 in Subjects With Presbyopia",COMPLETED,,PHASE3,230.0,ACTUAL,Allergan,,2.0,,,f,,,,f,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,INDUSTRY,,,,,,,2022,1.0
NCT03737617,,2017-07-19,,,2021-09-28,2018-11-07,2018-11-09,ACTUAL,,,,,,,2021-09-28,2021-09-29,ACTUAL,2022-08-05,ESTIMATED,2022-08-05,2021-09,2021-09-30,2024-12-01,ESTIMATED,2024-12-01,2024-08-01,ESTIMATED,2024-08-01,,INTERVENTIONAL,,,Immunoglobulin Replacement Therapy for Immunoglobulin G Subclass 2 Deficient Patients With Bronchiectasis,Immunoglobulin Replacement Therapy for Immunoglobulin G Subclass 2 Deficient Patients With Bronchiectasis- A Proof of Concept Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Edinburgh,,2.0,,Cant obtain IMP,f,,,,f,f,f,,,,,,,,,NO,No plan to share IPD- will present overall data,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,OTHER,,,,,,,2024,0.0
NCT02747797,,2016-03-22,,,2018-07-31,2016-04-19,2016-04-22,ESTIMATED,,,,,,,2018-07-31,2018-08-02,ACTUAL,2017-04,ESTIMATED,2017-04-30,2018-07,2018-07-31,2022-04,ESTIMATED,2022-04-30,2021-04,ESTIMATED,2021-04-30,,INTERVENTIONAL,,,"Lucitanib (E3810) in Patients With Advanced Cancer and FGFR, VEGFR, or PDGFR Pathway Aberrations","Histology-Independent Study of the Multikinase Inhibitor Lucitanib (E3810) in Patients With Advanced Cancer and Fibroblast Growth Factor Receptor (FGFR), Vascular Endothelial Growth Factor Receptors (VEGFR), or Platelet Derived Growth Factor Receptor (PDGFR) Pathway Aberrations",WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, San Diego",,1.0,,Drug Supply No Longer Available,f,,,,t,t,f,,,,,,,,,,,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,OTHER,,,,,,,2022,0.0
NCT04439071,,2020-06-17,2023-05-30,,2023-05-30,2020-06-17,2020-06-19,ACTUAL,2023-05-30,2023-06-26,ACTUAL,,,,2023-05-30,2023-06-26,ACTUAL,2020-07-09,ACTUAL,2020-07-09,2023-05,2023-05-31,2022-07-20,ACTUAL,2022-07-20,2022-07-20,ACTUAL,2022-07-20,,INTERVENTIONAL,FITE19,Safety population included all randomized participants who received at least 1 dose of study drug.,A Study to Evaluate Efficacy and Safety of PTC299 (Emvododstat) in Hospitalized Participants With Coronavirus (COVID-19),Evaluation of the Efficacy and Safety of PTC299 in Hospitalized Subjects With COVID-19 (FITE19),TERMINATED,,PHASE2/PHASE3,189.0,ACTUAL,PTC Therapeutics,,2.0,,Sponsor decision,,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 02:01:05.709567,2024-10-16 02:01:05.709567,INDUSTRY,,,,,,,2022,0.0
NCT03455556,,2018-02-28,2020-05-01,,2023-01-05,2018-02-28,2018-03-06,ACTUAL,2020-05-01,2020-05-15,ACTUAL,,,,2023-01-05,2023-01-06,ACTUAL,2018-08-10,ACTUAL,2018-08-10,2020-02,2020-02-29,2020-01-07,ACTUAL,2020-01-07,2019-09-11,ACTUAL,2019-09-11,,INTERVENTIONAL,,"Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.",Anetumab Ravtansine and Atezolizumab in Treating Participants With Advanced Non-small Cell Lung Cancer,"Phase I/II Study of the Human Anti-Mesothelin Antibody Drug Conjugate Anetumab Ravtansine (AR), Combined With the PD-L1 Inhibitor Atezolizumab in Non-Small Cell Lung Cancer",TERMINATED,,PHASE1,1.0,ACTUAL,Mayo Clinic,,1.0,,slow accrual,,,,,t,t,f,,,,,,,,,,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,OTHER,,,,,,,2020,0.0
NCT04166383,,2019-11-15,2023-03-27,,2023-10-13,2019-11-15,2019-11-18,ACTUAL,2023-05-12,2023-06-09,ACTUAL,,,,2023-10-13,2023-11-08,ACTUAL,2020-08-09,ACTUAL,2020-08-09,2023-10,2023-10-31,2022-12-31,ACTUAL,2022-12-31,2022-04-12,ACTUAL,2022-04-12,,INTERVENTIONAL,,,VB-111 in Combination With Nivolumab in People With Metastatic Colorectal Cancer (mCRC),Phase II Trial of VB-111 in Combination With Nivolumab in Patients With Metastatic Colorectal Cancer (mCRC).,COMPLETED,,PHASE2,14.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,,f,,,,f,t,f,,,,,,Clinical data available during the study and indefinitely.,Clinical data will be made available via subscription to the Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).,,YES,All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.,2024-10-16 02:01:05.709567,2024-10-16 02:01:05.709567,NIH,,,,,,,2022,1.0
NCT05387668,,2022-05-18,,,2022-12-14,2022-05-19,2022-05-24,ACTUAL,,,,,,,2022-12-14,2022-12-16,ACTUAL,2022-02-17,ACTUAL,2022-02-17,2022-12,2022-12-31,2022-10-17,ESTIMATED,2022-10-17,2022-10-17,ESTIMATED,2022-10-17,,INTERVENTIONAL,,,"Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Japanese and Caucasian Subjects","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Japanese and Caucasian Subjects",WITHDRAWN,,PHASE1,0.0,ACTUAL,BeiGene,,2.0,,Sponsor determined the data was no longer needed.,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,INDUSTRY,,,,,,,2022,0.0
NCT05296525,,2022-03-16,,,2024-05-01,2022-03-16,2022-03-25,ACTUAL,,,,,,,2024-05-01,2024-05-02,ACTUAL,2022-07-05,ACTUAL,2022-07-05,2024-05,2024-05-31,2024-04-22,ACTUAL,2024-04-22,2024-04-22,ACTUAL,2024-04-22,,INTERVENTIONAL,,,Evaluation of Safety and Efficacy of Allo GDA-201 NK Cells in Patients With Relapsed/Refractory B Cell NHL,A Phase I/II Multicenter Study Evaluating the Safety and Efficacy of Allogeneic GDA-201 Natural Killer Cells in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma,TERMINATED,,PHASE1/PHASE2,13.0,ACTUAL,Gamida Cell ltd,,1.0,,Study terminated by Sponsor.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 02:01:05.709567,2024-10-16 02:01:05.709567,INDUSTRY,,,,,,,2024,0.0
NCT03237325,,2017-07-26,2022-08-03,,2022-10-10,2017-07-28,2017-08-02,ACTUAL,2022-08-03,2022-08-29,ACTUAL,,,,2022-10-10,2022-11-08,ACTUAL,2017-12-04,ACTUAL,2017-12-04,2022-10,2022-10-31,2021-06-24,ACTUAL,2021-06-24,2020-06-24,ACTUAL,2020-06-24,,INTERVENTIONAL,,The baseline analysis population was defined as all participants that were treated with at least one dose of treatment (SGX942 or Placebo),DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer,"A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck",COMPLETED,,PHASE3,266.0,ACTUAL,Soligenix,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 11:28:50.881315,2024-10-16 11:28:50.881315,INDUSTRY,,,,,,,2021,1.0
NCT03660657,,2018-08-23,,,2022-04-01,2018-09-04,2018-09-06,ACTUAL,,,,,,,2022-04-01,2022-04-04,ACTUAL,2020-02-26,ACTUAL,2020-02-26,2022-04,2022-04-30,2020-11-30,ACTUAL,2020-11-30,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,O3Cardio,,Ozone Therapy in Refractory Ischemic Heart Disease.,"Effectiveness and Cost-effectiveness of Ozone Therapy in Patients With Ischemic Heart Disease Refractory to Medical and Surgical Treatment: Randomized, Triple-blind Clinical Trial",TERMINATED,,PHASE2/PHASE3,1.0,ACTUAL,Dr. Negrin University Hospital,,2.0,,Very low recruitment. During COVID-19 pandemic these are patients of high risk.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 11:35:27.617594,2024-10-16 11:35:27.617594,OTHER,,,,,,,2020,0.0
NCT02646748,,2016-01-04,,,2022-03-30,2016-01-04,2016-01-06,ESTIMATED,,,,,,,2022-03-30,2022-03-31,ACTUAL,2016-01-25,ACTUAL,2016-01-25,2022-03,2022-03-31,2020-11-20,ACTUAL,2020-11-20,2019-11-07,ACTUAL,2019-11-07,,INTERVENTIONAL,,,Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors,"A Platform Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Pembrolizumab + INCB Combinations in Advanced Solid Tumors",COMPLETED,,PHASE1,159.0,ACTUAL,Incyte Corporation,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 02:01:05.709567,2024-10-16 02:01:05.709567,INDUSTRY,,,,,,,2020,0.0
NCT03484520,,2018-03-26,,,2022-12-28,2018-03-26,2018-03-30,ACTUAL,,,,,,,2022-12-28,2022-12-30,ACTUAL,2018-07-23,ACTUAL,2018-07-23,2022-12,2022-12-31,2022-12-01,ACTUAL,2022-12-01,2022-12-01,ACTUAL,2022-12-01,,INTERVENTIONAL,,,A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia,Phase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia,TERMINATED,,PHASE1,48.0,ACTUAL,AbbVie,,1.0,,Strategic considerations,t,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 02:01:05.709567,2024-10-16 02:01:05.709567,INDUSTRY,,NCT03123029,AVAILABLE,,,,2022,0.0
NCT04190433,,2019-12-05,,,2023-05-22,2019-12-05,2019-12-09,ACTUAL,,,,,,,2023-05-22,2023-05-24,ACTUAL,2020-09-01,ACTUAL,2020-09-01,2023-05,2023-05-31,2023-04-18,ACTUAL,2023-04-18,2023-04-18,ACTUAL,2023-04-18,,INTERVENTIONAL,,,"Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial",AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment (ATACAR) Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,Mayo Clinic,,2.0,,Administratively closed due to low/no accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-16 02:01:05.709567,2024-10-16 02:01:05.709567,OTHER,,,,,,,2023,0.0
NCT02918500,,2016-09-06,2021-09-27,,2022-01-03,2016-09-26,2016-09-29,ESTIMATED,2021-12-03,2021-12-06,ACTUAL,,,,2022-01-03,2022-01-05,ACTUAL,2017-10-23,ACTUAL,2017-10-23,2022-01,2022-01-31,2020-07-31,ACTUAL,2020-07-31,2020-07-31,ACTUAL,2020-07-31,,INTERVENTIONAL,,,Effect of Pre-op NRT on Peri-operative Complications and Long-term Abstinence: A Pilot Trial in Patients Undergoing CABG Surgery,Effect of Pre-operative Nicotine Replacement Therapy on Peri-operative Complications and Long-term Abstinence: A Pilot Placebo-controlled Trial in Patients Undergoing Coronary Artery Bypass Surgery (CABG),TERMINATED,,PHASE4,4.0,ACTUAL,Ottawa Heart Institute Research Corporation,Study was terminated early due to recruitment challenges; only 4 participants were recruited. The data for these 4 participants will not be analyzed.,2.0,,Due to recruitment challenges.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,OTHER,,,,,,,2020,0.0
NCT04337827,,2020-04-06,2023-08-29,,2024-03-14,2020-04-06,2020-04-08,ACTUAL,2024-03-14,2024-04-10,ACTUAL,,,,2024-03-14,2024-04-10,ACTUAL,2020-09-02,ACTUAL,2020-09-02,2024-03,2024-03-31,2022-12-19,ACTUAL,2022-12-19,2022-06-27,ACTUAL,2022-06-27,,INTERVENTIONAL,,,Rituximab and Acalabrutinib in Newly Diagnosed B Cell Post Transplant Lymphoproliferative Disorder,Phase II Study of Rituximab and Acalabrutinib in Newly Diagnosed B Cell Post Transplant Lymphoproliferative Disorder (PTLD),TERMINATED,,PHASE2,6.0,ACTUAL,Case Comprehensive Cancer Center,"Early termination leading to small numbers of subjects, unable to perform analysis of data.",1.0,,Slow accrual,f,,,,t,t,f,,,,,,,,,NO,There are no plans to share individual patient data in order to protect the confidentiality of the subjects who enroll on this study,2024-10-16 11:35:27.617594,2024-10-16 11:35:27.617594,OTHER,,,,,,,2022,0.0
NCT03593109,,2018-07-07,,,2021-10-28,2018-07-18,2018-07-19,ACTUAL,,,,,,,2021-10-28,2021-11-01,ACTUAL,2019-05-30,ACTUAL,2019-05-30,2020-11,2020-11-30,2021-05-01,ACTUAL,2021-05-01,2021-05-01,ACTUAL,2021-05-01,,INTERVENTIONAL,,,"A Single-center Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-L10D Cell Formulations Targeting CD19 and CD22 in Patients With CD19- and/or CD22-Positive Relapsed/Refractory B-cell Lymphoma","A Single-center Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-L10D Cell Formulations Targeting CD19 and CD22 in Patients With CD19- and/or CD22-Positive Relapsed/Refractory B-cell Lymphoma",TERMINATED,,PHASE1,1.0,ACTUAL,Second Affiliated Hospital of Xi'an Jiaotong University,,1.0,,Suitable patients were not recruited,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 11:35:27.617594,2024-10-16 11:35:27.617594,OTHER,,,,,,,2021,0.0
NCT05067946,,2021-10-04,,,2022-04-04,2021-10-04,2021-10-05,ACTUAL,,,,,,,2022-04-04,2022-04-12,ACTUAL,2021-10,ESTIMATED,2021-10-31,2021-07,2021-07-31,2023-10,ESTIMATED,2023-10-31,2022-10,ESTIMATED,2022-10-31,,INTERVENTIONAL,,,"Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines","A Phase 2/3, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of GX-19N, A DNA Vaccine, in Healthy Individuals Who Have Received One of the COVID-19 Vaccines",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,"Genexine, Inc.",,2.0,,Change of development strategy in consideration of the global COVID-19 situation,f,,,,,f,f,,,,,,,,,,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,INDUSTRY,,,,,,,2023,0.0
NCT02203604,,2014-07-28,2022-09-01,,2023-07-03,2014-07-28,2014-07-30,ESTIMATED,2023-05-24,2023-06-18,ACTUAL,,,,2023-07-03,2023-07-18,ACTUAL,2014-11-26,ACTUAL,2014-11-26,2023-07,2023-07-31,2020-01-27,ACTUAL,2020-01-27,2020-01-27,ACTUAL,2020-01-27,,INTERVENTIONAL,,,High-Dose Aldesleukin and Ipilimumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed By Surgery,A Phase II Single Arm Study of High-Dose IL-2 and Ipilimumab in Patients With Unresectable Stage III and Stage IV Melanoma,TERMINATED,,PHASE2,9.0,ACTUAL,"Rutgers, The State University of New Jersey",The trial was closed early due to slow accrual. Early termination lead to a small number of subjects analyzed.,1.0,,Insufficient rate of accrual,f,,,,t,,,,,,,,,,,NO,,2024-10-16 11:35:27.617594,2024-10-16 11:35:27.617594,OTHER,,,,,,,2020,0.0
NCT04566133,,2020-09-25,2023-05-12,,2023-07-28,2020-09-25,2020-09-28,ACTUAL,2023-07-28,2023-08-21,ACTUAL,,,,2023-07-28,2023-08-21,ACTUAL,2022-02-15,ACTUAL,2022-02-15,2023-07,2023-07-31,2022-12-31,ACTUAL,2022-12-31,2022-05-11,ACTUAL,2022-05-11,,INTERVENTIONAL,,,Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC).,Phase II Study of Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC).,TERMINATED,,PHASE2,2.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,Slow accrual,f,,,,f,t,f,,,f,,,Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing Plan (GDS) plan for as long as database is active.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.,,YES,"All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).",2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,NIH,,,,,,,2022,0.0
NCT02183805,,2014-07-01,,,2021-07-18,2014-07-02,2014-07-08,ESTIMATED,,,,,,,2021-07-18,2021-07-23,ACTUAL,2014-06-17,ACTUAL,2014-06-17,2021-07,2021-07-31,2020-12-15,ACTUAL,2020-12-15,2020-12-15,ACTUAL,2020-12-15,,INTERVENTIONAL,,,Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Metastatic Triple-negative Breast Cancer,Phase II Study of Chemotherapy Followed by Peripheral Stem Cell Transplantation as First Line Therapy for Metastatic Triple-negative Breast Cancer,TERMINATED,,PHASE2,6.0,ACTUAL,Sun Yat-sen University,,1.0,,Difficulty accruing subjects the study accrual was closed,f,,,,t,,,,,,,,,,,NO,,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,OTHER,,,,,,,2020,0.0
NCT01776424,,2013-01-24,2018-07-16,,2022-11-03,2013-01-25,2013-01-28,ESTIMATED,2018-09-06,2018-10-05,ACTUAL,,,,2022-11-03,2022-11-28,ACTUAL,2013-02-28,ACTUAL,2013-02-28,2022-11,2022-11-30,2021-06-15,ACTUAL,2021-06-15,2017-07-21,ACTUAL,2017-07-21,,INTERVENTIONAL,COMPASS,Intent-to-treat analysis set (ITT): included all participants randomized to antithrombotic treatment for the initial study part. The ITT set comprised both participants randomized to pantoprazole/placebo and participants not randomized to pantoprazole/placebo.,Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease,A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS).,COMPLETED,,PHASE3,27395.0,ACTUAL,Bayer,One participant that was included in the Safety Analysis Set in the disclosure after primary completion never took any study drug therefore was corrected in the later analysis.,3.0,,,f,,,,t,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-16 02:01:05.709567,2024-10-16 02:01:05.709567,INDUSTRY,,,,,,,2021,1.0
NCT03075241,,2017-03-05,,,2020-11-08,2017-03-05,2017-03-09,ACTUAL,,,,,,,2020-11-08,2020-11-10,ACTUAL,2016-10,ACTUAL,2016-10-31,2020-11,2020-11-30,2020-04,ACTUAL,2020-04-30,2020-04,ACTUAL,2020-04-30,,INTERVENTIONAL,,,Z-Drugs for Sleep Disorders in Alzheimer's Disease,"Z-Drugs for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomized, Triple-blind, Placebo-controlled Study",COMPLETED,,PHASE3,62.0,ACTUAL,Brasilia University Hospital,,3.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,OTHER,,,,,,,2020,0.0
NCT04230213,,2020-01-14,2022-06-17,,2024-01-26,2020-01-14,2020-01-18,ACTUAL,2022-07-29,2022-08-22,ACTUAL,,,,2024-01-26,2024-02-22,ACTUAL,2020-01-13,ACTUAL,2020-01-13,2024-01,2024-01-31,2021-06-22,ACTUAL,2021-06-22,2021-06-22,ACTUAL,2021-06-22,,INTERVENTIONAL,,Baseline analysis population included all the participants who were enrolled in TP1.,A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis,A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA (REGISTERED) IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS,COMPLETED,,PHASE3,455.0,ACTUAL,Pfizer,"In participant flow, there were discontinuations due to AEs, which were captured within different reasons for discontinuations (e.g. other, physician decision etc.) as the study case report form (CRF) page did not include AE as an option for sites to record if the discontinuation was truly due to AE.",2.0,,,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,INDUSTRY,,,,,,,2021,0.0
NCT04591444,,2020-10-11,,,2020-10-16,2020-10-11,2020-10-19,ACTUAL,,,,,,,2020-10-16,2020-10-20,ACTUAL,2017-01,ACTUAL,2017-01-31,2020-10,2020-10-31,2020-03,ACTUAL,2020-03-31,2019-10,ACTUAL,2019-10-31,,INTERVENTIONAL,,,Fluoride Varnish X Glass Ionomer Sealant on Cervical Dentin Hypersensitivity,Efficacy of a Fluoride Varnish and a Glass Ionomer Sealant on Cervical Dentin Hypersensitivity: A Randomized Clinical Trial,COMPLETED,,PHASE3,121.0,ACTUAL,University of Sao Paulo,,3.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,OTHER,,,,,,,2020,1.0
NCT02899702,,2016-09-02,,,2021-04-28,2016-09-08,2016-09-14,ESTIMATED,,,,,,,2021-04-28,2021-05-03,ACTUAL,2020-09,ESTIMATED,2020-09-30,2021-04,2021-04-30,2024-09,ESTIMATED,2024-09-30,2024-09,ESTIMATED,2024-09-30,,INTERVENTIONAL,IGHN2,,Effectiveness of Intravenous Immunoglobulins (IVIG) in Toxic Shock Syndromes in Children,Effectiveness of Intravenous Immunoglobulins (IVIG) in Toxic Shock Syndromes in Children: a Multicentre European Randomized Controlled Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,Hospices Civils de Lyon,,2.0,,no EC approval obtained,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,OTHER,,,,,,,2024,0.0
NCT03149120,,2017-04-27,,,2017-08-17,2017-05-09,2017-05-11,ACTUAL,,,,,,,2017-08-17,2017-08-22,ACTUAL,2017-08,ESTIMATED,2017-08-31,2017-08,2017-08-31,2022-06,ESTIMATED,2022-06-30,2017-08-17,ACTUAL,2017-08-17,,INTERVENTIONAL,,,Study of Nivolumab With or Without Pazopanib in Metastatic or Unresectable Soft Tissue Sarcomas,Phase II Randomized Study of Nivolumab With or Without Pazopanib in Metastatic or Unresectable Soft Tissue Sarcomas After One Prior Line of Systemic Therapy or Ineligible to Receive an Anthracycline-based Treatment,WITHDRAWN,,PHASE2,0.0,ACTUAL,NYU Langone Health,,2.0,,No patient enrolled as new similar study will be in system within 3 months,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,OTHER,,,,,,,2022,0.0
NCT03854396,,2019-02-24,,,2021-06-25,2019-02-24,2019-02-26,ACTUAL,,,,,,,2021-06-25,2021-06-30,ACTUAL,2020-05,ESTIMATED,2020-05-31,2021-06,2021-06-30,2021-02,ESTIMATED,2021-02-28,2021-02,ESTIMATED,2021-02-28,,INTERVENTIONAL,,,Clinical Trial on the Preventive Effect of Intravaginal Prasterone on Recurrent Urinary Tract Infections in Postmenopausal Women,"A Randomized, Double-blind, Placebo-controlled Trial on the Preventive Effect of Intravaginal Prasterone (DHEA, Intrarosa®) on Recurrent Urinary Tract Infections in Women With Genitourinary Syndrome of Menopause",WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Louisville,,2.0,,due to termination of ISR by PI with agreement by grant sponsor,f,,,,f,t,f,,,t,,,Data will be available beginning 1 month and ending 24 months following article publication.,"Available to investigators whose proposed use of the data is for individual participant data meta-analysis and has been approved by an independent review committee for this purpose. To gain access, data requestors will need to sign a data access agreement.",,YES,De-identified raw data and other supporting materials will be made available to approved investigators. Email requests to olivia.cardenas-trowers@louisville.edu.,2024-10-16 02:01:05.709567,2024-10-16 02:01:05.709567,OTHER,,,,,,,2021,0.0
NCT04032691,,2019-07-19,,,2021-07-14,2019-07-22,2019-07-25,ACTUAL,,,,,,,2021-07-14,2021-07-20,ACTUAL,2019-08-27,ACTUAL,2019-08-27,2021-07,2021-07-31,2021-05-24,ACTUAL,2021-05-24,2021-05-24,ACTUAL,2021-05-24,,INTERVENTIONAL,,,PET Study of a2a Agonist Effects on the Ventricular CSF Clearance of [11C]Butanol,The Effects of Alpha-2 Adrenergic Receptor Modulation on Rates of Carbon-11 Butanol Clearance From Ventricular Cerebrospinal Fluid,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Weill Medical College of Cornell University,,1.0,,lack of funding,f,,,,f,t,f,,,f,,,Available at end of study (anticipated date = 31 Dec 2020) for up to five years.,All investigators who provide a brief statement expressing a scientific interest.,,YES,"The safety data will be shared. Data will be from the lead-in period, the on-drug period, and the washout period. Safety data include vital signs, electrocardiogram parameters, and quality of sleep measures.",2024-10-16 02:01:05.709567,2024-10-16 02:01:05.709567,OTHER,,,,,,,2021,0.0
NCT03714334,,2018-10-16,,,2023-04-05,2018-10-19,2018-10-22,ACTUAL,,,,,,,2023-04-05,2023-04-07,ACTUAL,2018-10-16,ACTUAL,2018-10-16,2023-04,2023-04-30,2023-04-05,ACTUAL,2023-04-05,2023-04-05,ACTUAL,2023-04-05,,INTERVENTIONAL,,,DNX-2440 Oncolytic Adenovirus for Recurrent Glioblastoma,Phase I Trial of DNX-2440 Oncolytic Adenovirus in Patients With Recurrent Glioblastoma,TERMINATED,,PHASE1,16.0,ACTUAL,"Clinica Universidad de Navarra, Universidad de Navarra",,1.0,,Break of stock,f,,,,f,f,f,,,,,,,,,,,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,OTHER,,,,,,,2023,0.0
NCT04652245,,2020-11-20,2022-12-13,,2023-02-24,2020-11-26,2020-12-03,ACTUAL,2023-02-24,2023-03-23,ACTUAL,,,,2023-02-24,2023-03-23,ACTUAL,2020-12-14,ACTUAL,2020-12-14,2023-02,2023-02-28,2021-12-13,ACTUAL,2021-12-13,2021-12-04,ACTUAL,2021-12-04,,INTERVENTIONAL,,"FAS population includes all randomized patients, including subjects who received incorrect treatment, did not complete the study or did not comply to the protocol, and who were randomized but did not take any study medication",Dymista Allergen Chamber - Onset of Action Study,Clinical Trial to Assess Onset of Action of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray Delivered in a Single Spray (Dymista) in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in Comparison to Placebo in an Environmental Exposure Unit (EEU),COMPLETED,,PHASE4,216.0,ACTUAL,Viatris Inc.,,2.0,,,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 11:35:27.617594,2024-10-16 11:35:27.617594,INDUSTRY,,,,,,,2021,1.0
NCT00004935,,2000-03-07,,,2023-04-12,2003-01-26,2003-01-27,ESTIMATED,,,,,,,2023-04-12,2023-04-18,ACTUAL,1999-08-30,ACTUAL,1999-08-30,2022-03,2022-03-31,2022-03-31,ACTUAL,2022-03-31,2014-11-06,ACTUAL,2014-11-06,,INTERVENTIONAL,,,Herceptin Followed by Chemotherapy in Treating Women With Metastatic Breast Cancer That Overexpresses HER2,Randomized Phase III Trial of Herceptin® Followed by Chemotherapy Plus Herceptin® Versus the Combination of Herceptin® and Chemotherapy as Palliative Treatment in Patients With HER2- Overexpressing Advanced/Metastatic Breast Cancer.,TERMINATED,,PHASE3,175.0,ACTUAL,Swiss Group for Clinical Cancer Research,,2.0,,Trial is Life long follow-up: to reduce ressources and costs - trial terminated prematurely.,f,,,,t,,,,,,,,,,,,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,OTHER,,,,,,,2022,0.0
NCT04940624,,2021-06-16,,,2024-04-30,2021-06-18,2021-06-25,ACTUAL,,,,,,,2024-04-30,2024-05-01,ACTUAL,2021-10-28,ACTUAL,2021-10-28,2024-04,2024-04-30,2024-04-11,ACTUAL,2024-04-11,2024-04-11,ACTUAL,2024-04-11,,INTERVENTIONAL,,,A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet Syndrome (DS)",COMPLETED,,PHASE3,144.0,ACTUAL,Takeda,,2.0,,,f,,,,t,t,f,,,t,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 11:35:27.617594,2024-10-16 11:35:27.617594,INDUSTRY,,,,,,,2024,0.0
NCT05001451,,2021-07-05,,,2022-07-18,2021-08-04,2021-08-12,ACTUAL,,,,,,,2022-07-18,2022-07-20,ACTUAL,2021-08-13,ACTUAL,2021-08-13,2022-07,2022-07-31,2022-06-03,ACTUAL,2022-06-03,2022-06-03,ACTUAL,2022-06-03,,INTERVENTIONAL,,,Study of GDX012 in Patients With MRD Positive AML,"A Phase 1, Open Label, Dose Escalation, and Dose Expansion Study to Assess the Safety, Tolerability, and Preliminary Antileukemic Activity of GDX012 in Patients With Minimal Residual Disease (MRD) Positive Acute Myeloid Leukemia",TERMINATED,,PHASE1,3.0,ACTUAL,GammaDelta Therapeutics Limited,,1.0,,"This was a business decision to discontinue this clinical trial. The decision is not related to the safety of the investigational product, GDX012.",f,,,,,t,f,,,,,,,,,NO,,2024-10-16 02:01:05.709567,2024-10-16 02:01:05.709567,INDUSTRY,,,,,,,2022,0.0
NCT05066698,,2021-09-23,,,2022-10-24,2021-09-23,2021-10-04,ACTUAL,,,,,,,2022-10-24,2022-10-25,ACTUAL,2022-04-27,ACTUAL,2022-04-27,2022-10,2022-10-31,2022-09-07,ACTUAL,2022-09-07,2022-09-07,ACTUAL,2022-09-07,,INTERVENTIONAL,,,ST266 Eyedrops for the Treatment of Persistent Corneal Epithelial Defects,"A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of ST266 Eye Drops in the Treatment of Persistent Corneal Epithelial Defects",TERMINATED,,PHASE2,8.0,ACTUAL,"Noveome Biotherapeutics, formerly Stemnion",,2.0,,Sponsor undergoing financial hardships - no longer able to support trial; no safety concerns.,,,,,,t,f,,,,,,,,,,,2024-10-16 02:01:05.709567,2024-10-16 02:01:05.709567,INDUSTRY,,,,,,,2022,0.0
NCT05489991,,2022-07-22,,,2023-08-15,2022-08-03,2022-08-05,ACTUAL,,,,,,,2023-08-15,2023-08-18,ACTUAL,2022-09-06,ACTUAL,2022-09-06,2023-08,2023-08-31,2023-05-03,ACTUAL,2023-05-03,2023-05-03,ACTUAL,2023-05-03,,INTERVENTIONAL,,,A Study of TmPSMA-02 Chimeric Antigen Receptor (CAR) T-cells in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC),"A Phase 1/2, Open-label, Multi-Center Study of Dually Armored Chimeric Antigen Receptor (CAR) T-cells (TmPSMA-02) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)",TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,"Tceleron Therapeutics, Inc.",,1.0,,Study was stopped Sponsor discretion. No patients were dosed.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,INDUSTRY,,,,,,,2023,0.0
NCT04106050,,2019-09-25,,,2021-03-19,2019-09-25,2019-09-26,ACTUAL,,,,,,,2021-03-19,2021-03-22,ACTUAL,2020-09-30,ESTIMATED,2020-09-30,2021-03,2021-03-31,2022-01-21,ESTIMATED,2022-01-21,2022-01-21,ESTIMATED,2022-01-21,,INTERVENTIONAL,,,Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy,"A Phase 1b, Randomized, Double-Blind, Parallel, Placebo- and Active-Controlled, Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy",WITHDRAWN,,PHASE1,0.0,ACTUAL,Biogen,,7.0,,Sponsor Decision,f,,,,,f,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,INDUSTRY,,,,,,,2022,0.0
NCT04925986,,2021-06-08,,,2024-01-26,2021-06-08,2021-06-14,ACTUAL,,,,,,,2024-01-26,2024-01-30,ACTUAL,2022-02-10,ACTUAL,2022-02-10,2024-01,2024-01-31,2023-10-30,ACTUAL,2023-10-30,2023-06-22,ACTUAL,2023-06-22,,INTERVENTIONAL,,,Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Naïve PD-L1+ Non-Squamous NSCLC,Phase 2 Trial of Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Naïve PD-L1+ Non-Squamous Non-Small Cell Lung Cancer,TERMINATED,,PHASE2,9.0,ACTUAL,Yale University,,4.0,,Sponsor decision based on data from other clinical trials,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,OTHER,,,,,,,2023,0.0
NCT04409327,,2020-05-28,,,2021-02-05,2020-05-28,2020-06-01,ACTUAL,,,,,,,2021-02-05,2021-02-10,ACTUAL,2020-07-11,ACTUAL,2020-07-11,2021-02,2021-02-28,2021-01-24,ACTUAL,2021-01-24,2020-12-27,ACTUAL,2020-12-27,,INTERVENTIONAL,,,Phase 2 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults Residing in Nursing Homes,Randomized Double Blind Placebo-Controlled Study to Determine if Prophylaxis With RTB101 Compared to Placebo Reduces Severity of Lab Confirmed COVID19 in Adults ≥65 Years in a Nursing Home in Which ≥1 Person(s) Have Lab Confirmed COVID19,TERMINATED,,PHASE2,36.0,ACTUAL,Restorbio Inc.,,2.0,,Insufficient accrual rate,f,,,,t,t,f,,,,,,,,,,,2024-10-16 11:35:27.617594,2024-10-16 11:35:27.617594,INDUSTRY,,,,,,,2021,0.0
NCT04702425,,2020-12-02,,,2024-08-30,2021-01-07,2021-01-08,ACTUAL,,,,,,,2024-08-30,2024-09-04,ACTUAL,2021-06-23,ACTUAL,2021-06-23,2024-08,2024-08-31,2024-07-23,ACTUAL,2024-07-23,2024-07-23,ACTUAL,2024-07-23,,INTERVENTIONAL,,,"VOB560-MIK665 Combination First in Human Trial in Patients With Hematological Malignancies (Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma)","A Phase Ib, Multicenter Study of VOB560 in Combination With MIK665 in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma.",TERMINATED,,PHASE1,37.0,ACTUAL,Novartis,,6.0,,Business reasons,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,INDUSTRY,,,,,,,2024,0.0
NCT04534881,,2020-08-17,2024-01-18,,2024-02-20,2020-08-27,2020-09-01,ACTUAL,2024-02-20,2024-03-19,ACTUAL,,,,2024-02-20,2024-03-19,ACTUAL,2020-10-20,ACTUAL,2020-10-20,2024-02,2024-02-29,2023-01-18,ACTUAL,2023-01-18,2023-01-18,ACTUAL,2023-01-18,,INTERVENTIONAL,,,Effect of Progesterone on Testosterone Concentrations and Breast Development in Transwomen,Effect of Progesterone on Testosterone Concentrations and Breast Development in Transwomen,TERMINATED,,PHASE2,5.0,ACTUAL,St. Louis University,,2.0,,lack of recruitment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,OTHER,,,,,,,2023,0.0
NCT04948554,,2021-06-04,,,2023-11-21,2021-06-24,2021-07-02,ACTUAL,,,,,,,2023-11-21,2023-11-24,ACTUAL,2023-03-10,ACTUAL,2023-03-10,2023-11,2023-11-30,2023-10-18,ACTUAL,2023-10-18,2023-10-18,ACTUAL,2023-10-18,,INTERVENTIONAL,,,A Study of MK-2225 / ACE-1334 in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002),"A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of ACE-1334 Plus Standard of Care in Participants With Systemic Sclerosis",TERMINATED,,PHASE1,5.0,ACTUAL,"Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA",,12.0,,Business Reasons,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 23:12:22.934215,2024-10-16 23:12:22.934215,INDUSTRY,,,,,,,2023,0.0
NCT03777319,,2018-12-10,2022-11-28,,2023-10-20,2018-12-13,2018-12-17,ACTUAL,2023-10-20,2023-10-23,ACTUAL,,,,2023-10-20,2023-10-23,ACTUAL,2018-12-05,ACTUAL,2018-12-05,2023-10,2023-10-31,2021-11-30,ACTUAL,2021-11-30,2021-09-27,ACTUAL,2021-09-27,,INTERVENTIONAL,,,Spironolactone Versus Prednisolone in DMD,A Randomized Open Label Trial of Spironolactone Versus Prednisolone in Corticosteroid-naïve Boys With DMD,TERMINATED,,PHASE1,2.0,ACTUAL,Nationwide Children's Hospital,Full enrollment into the study was unable to be obtained.,2.0,,Inability to recruit participants.,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,OTHER,,,,,,,2021,0.0
NCT03794154,,2018-12-20,,,2019-09-25,2019-01-03,2019-01-04,ACTUAL,,,,,,,2019-09-25,2019-09-27,ACTUAL,2020-03-30,ESTIMATED,2020-03-30,2019-09,2019-09-30,2020-06-05,ESTIMATED,2020-06-05,2020-06-05,ESTIMATED,2020-06-05,,INTERVENTIONAL,,,A Study Of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta Under Fed Conditions,"A PHASE IV, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY TO DETERMINE THE BIOEQUIVALENCE OF DULOXETINE HYDROCHLORIDE HARD GELATINOUS CAPSULE WITH DELAYED RELEASE MICROGRANULES (60 MG; PFIZER S.R.L - ARGENTINA.) COMPARED TO CYMBALTA (REGISTERED) MICROGRANULES (60 MG; ELI LILLY DO BRASIL LTDA) IN HEALTHY MALE RESEARCH SUBJECTS UNDER FED CONDITIONS",WITHDRAWN,,PHASE4,0.0,ACTUAL,Pfizer,,2.0,,This study has been cancelled prior to FSFV due to business reasons,f,,,,,f,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,INDUSTRY,,,,,,,2020,0.0
NCT03800290,,2018-12-06,,,2022-11-28,2019-01-08,2019-01-11,ACTUAL,,,,,,,2022-11-28,2022-12-01,ACTUAL,2019-06-01,ACTUAL,2019-06-01,2020-07,2020-07-31,2021-04-23,ACTUAL,2021-04-23,2021-04-23,ACTUAL,2021-04-23,,INTERVENTIONAL,,,Human Beta-2 Adrenergic Stimulation and Muscle Glucose Uptake,Targeting the Beta-2-adrenergic Pathway to Improve Skeletal Muscle Glucose Uptake in Healthy Humans,COMPLETED,,PHASE2,11.0,ACTUAL,Maastricht University,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,OTHER,,,,,,,2021,1.0
NCT01660451,,2012-08-06,2017-10-13,,2024-06-25,2012-08-06,2012-08-08,ESTIMATED,2017-12-08,2018-01-08,ACTUAL,,,,2024-06-25,2024-07-17,ACTUAL,2012-11-19,ACTUAL,2012-11-19,2024-06,2024-06-30,2023-05-18,ACTUAL,2023-05-18,2016-06-22,ACTUAL,2016-06-22,,INTERVENTIONAL,,Full Analysis Set (FAS) included all participants assigned to study treatment.,"Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas","Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas",COMPLETED,,PHASE2,227.0,ACTUAL,Bayer,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2023,1.0
NCT03457701,,2018-03-01,2023-07-04,,2024-03-26,2018-03-01,2018-03-07,ACTUAL,2023-07-04,2023-07-25,ACTUAL,,,,2024-03-26,2024-03-27,ACTUAL,2019-07-30,ACTUAL,2019-07-30,2024-03,2024-03-31,2022-07-05,ACTUAL,2022-07-05,2022-07-05,ACTUAL,2022-07-05,,INTERVENTIONAL,,Safety population comprised of participants who received at least 1 dose of study treatment.,Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe),"A Repeat Dose, Open Label, Two Period, Randomized, Cross Over Study to Compare the Effect of Daprodustat to Recombinant, Human Erythropoietin (rhEPO) on Oral Iron Absorption in Adult Participants With Anemia Associated With Chronic Kidney Disease Who Are Not on Dialysis",COMPLETED,,PHASE2,15.0,ACTUAL,GlaxoSmithKline,,4.0,,,f,,,,f,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months .",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 11:35:27.617594,2024-10-16 11:35:27.617594,INDUSTRY,,,,,,,2022,1.0
NCT05319028,,2022-04-01,,,2023-03-31,2022-04-01,2022-04-08,ACTUAL,,,,,,,2023-03-31,2023-04-04,ACTUAL,2022-06-23,ACTUAL,2022-06-23,2023-03,2023-03-31,2023-02-24,ACTUAL,2023-02-24,2023-02-24,ACTUAL,2023-02-24,,INTERVENTIONAL,,,Study of Mivavotinib (CB-659) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL),A Phase 2 Study of Mivavotinib in Biomarker-Defined Subgroups of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL),TERMINATED,,PHASE2,2.0,ACTUAL,"Calithera Biosciences, Inc",,2.0,,Sponsor Decision,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2023,0.0
NCT04943627,,2021-06-04,,,2022-10-03,2021-06-21,2021-06-29,ACTUAL,,,,,,,2022-10-03,2022-10-05,ACTUAL,2021-08-02,ACTUAL,2021-08-02,2022-10,2022-10-31,2021-10-22,ACTUAL,2021-10-22,2021-10-22,ACTUAL,2021-10-22,,INTERVENTIONAL,,,Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer (BRAVA),A Phase 3 Trial of Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer After Platinum-Based Chemotherapy (BRAVA),WITHDRAWN,,PHASE3,0.0,ACTUAL,Agenus Inc.,,2.0,,Strategic Business Decision,f,,,,,t,f,,,,,,,,,,,2024-10-16 11:35:27.617594,2024-10-16 11:35:27.617594,INDUSTRY,,,,,,,2021,0.0
NCT04308668,,2020-03-11,2021-04-26,,2021-05-11,2020-03-11,2020-03-16,ACTUAL,2021-05-11,2021-05-13,ACTUAL,,,,2021-05-11,2021-05-13,ACTUAL,2020-03-17,ACTUAL,2020-03-17,2021-05,2021-05-31,2020-05-20,ACTUAL,2020-05-20,2020-05-20,ACTUAL,2020-05-20,,INTERVENTIONAL,COVID-19 PEP,,Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2,Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial,COMPLETED,,PHASE3,1312.0,ACTUAL,University of Minnesota,,2.0,,,f,,,,t,t,f,,,,,,at time of publication,To be publicly provided. Please register at the website to receive the dataset.,https://covidpep.umn.edu/data,YES,De-identified dataset will be available within 1 month of publication.,2024-10-16 11:35:27.617594,2024-10-16 11:35:27.617594,OTHER,,,,,,,2020,1.0
NCT02819856,,2016-06-16,,,2024-08-01,2016-06-27,2016-06-30,ESTIMATED,,,,,,,2024-08-01,2024-08-02,ACTUAL,2017-07-21,ACTUAL,2017-07-21,2024-08,2024-08-31,2023-04-07,ACTUAL,2023-04-07,2023-04-07,ACTUAL,2023-04-07,,INTERVENTIONAL,,,SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Cystic Fibrosis (CF) Patients With Acute Pulmonary Exacerbation (APE) Receiving IV Tobramycin at Risk for Ototoxicity",COMPLETED,,PHASE2,40.0,ACTUAL,"Sound Pharmaceuticals, Incorporated",,4.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,INDUSTRY,,,,,,,2023,1.0
NCT05788497,,2023-03-15,,,2024-02-23,2023-03-27,2023-03-29,ACTUAL,,,,,,,2024-02-23,2024-02-28,ACTUAL,2023-03-30,ACTUAL,2023-03-30,2024-02,2024-02-29,2024-01-04,ACTUAL,2024-01-04,2024-01-04,ACTUAL,2024-01-04,,INTERVENTIONAL,,,Efficacy and Safety of Hemorrane Plus Versus Hemorrane and Versus Placebo in Patients With Uncomplicated Haemorrhoids,"Multicentre, Double-blind, Randomised Clinical Trial to Evaluate and Compare the Efficacy and Safety of Hemorrane Plus (Hemorrane® + Benzocaine) With Hemorrane® and With Placebo in Patients With Uncomplicated Haemorrhoids",TERMINATED,,PHASE3,21.0,ACTUAL,"Faes Farma, S.A.",,3.0,,Recruitment failure,f,,,,f,f,f,,,,,,,,,,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,INDUSTRY,,,,,,,2024,0.0
NCT04341727,,2020-04-04,2022-02-04,,2024-04-23,2020-04-08,2020-04-10,ACTUAL,2024-04-23,2024-04-25,ACTUAL,,,,2024-04-23,2024-04-25,ACTUAL,2020-04-04,ACTUAL,2020-04-04,2024-04,2024-04-30,2021-04-01,ACTUAL,2021-04-01,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,WU352,,"Hydroxychloroquine,Hydroxychloroquine,Azithromycin in the Treatment of SARS CoV-2 Infection","Open-label, Randomized Controlled Trial of Hydroxychloroquine, Hydroxychloroquine Plus Azithromycin, Chloroquine Alone, Chloroquine Plus Azithromycin in the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) Infection",TERMINATED,,PHASE3,30.0,ACTUAL,Washington University School of Medicine,Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.,4.0,,DSMB recommended study suspension slow accrual,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2021,0.0
NCT02409342,,2015-04-01,2021-01-26,,2023-02-17,2015-04-01,2015-04-06,ESTIMATED,2021-01-26,2021-02-18,ACTUAL,,,,2023-02-17,2023-03-15,ACTUAL,2015-07-20,ACTUAL,2015-07-20,2023-02,2023-02-28,2022-03-08,ACTUAL,2022-03-08,2020-02-04,ACTUAL,2020-02-04,,INTERVENTIONAL,,,A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110],"A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer",COMPLETED,,PHASE3,572.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,INDUSTRY,,,,,,,2022,1.0
NCT02059265,,2014-02-07,2019-04-24,,2023-07-13,2014-02-07,2014-02-11,ESTIMATED,2019-04-24,2019-05-17,ACTUAL,,,,2023-07-13,2023-08-01,ACTUAL,2014-02-14,ACTUAL,2014-02-14,2023-07,2023-07-31,2023-06-26,ACTUAL,2023-06-26,2017-02-06,ACTUAL,2017-02-06,,INTERVENTIONAL,,,"Dasatinib in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, Endometrial or Peritoneal Cancer","A Phase II Trial of DCTD-Sponsored Dasatinib in Recurrent/Persistent Ovary, Fallopian Tube, Primary Peritoneal, and Endometrial Clear Cell Carcinoma Characterized for the Retention or Loss of BAF250a Expression",TERMINATED,,PHASE2,35.0,ACTUAL,National Cancer Institute (NCI),,1.0,,Interim monitoring,f,,,,t,,,,,,,,,,,,,2024-10-16 11:35:27.617594,2024-10-16 11:35:27.617594,NIH,,,,,,,2023,0.0
NCT02478255,,2015-06-16,2022-12-07,,2023-01-24,2015-06-18,2015-06-23,ESTIMATED,2023-01-24,2023-02-17,ACTUAL,,,,2023-01-24,2023-02-17,ACTUAL,2016-03-21,ACTUAL,2016-03-21,2023-01,2023-01-31,2022-01-13,ACTUAL,2022-01-13,2022-01-13,ACTUAL,2022-01-13,,INTERVENTIONAL,,,Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment,Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment,COMPLETED,,PHASE2,25.0,ACTUAL,Duke University,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,OTHER,,,,,,,2022,1.0
NCT03195270,,2017-06-19,,,2023-05-15,2017-06-20,2017-06-22,ACTUAL,,,,,,,2023-05-15,2023-05-16,ACTUAL,2014-11-24,ACTUAL,2014-11-24,2023-05,2023-05-31,2022-01-20,ACTUAL,2022-01-20,2022-01-20,ACTUAL,2022-01-20,,INTERVENTIONAL,,,Use of PET/MR Imaging in Chronic Pain,Use of [18F]FDG PET/MRI in the Diagnosis of Pain Generators and/or Sites of Inflammation and to Monitor Treatment Effects in Patients With Chronic Pain,COMPLETED,,PHASE1,88.0,ACTUAL,Stanford University,,1.0,,,f,,,,,t,f,,,f,,,,,,NO,There is currently no plan to share the individual participant data with other researchers outside our group of researchers or referring physicians.,2024-10-16 11:35:27.617594,2024-10-16 11:35:27.617594,OTHER,,,,,,,2022,1.0
NCT02163759,,2014-06-12,2021-01-29,,2021-07-21,2014-06-12,2014-06-16,ESTIMATED,2021-03-09,2021-04-05,ACTUAL,,,,2021-07-21,2021-07-23,ACTUAL,2014-11-04,ACTUAL,2014-11-04,2021-07,2021-07-31,2020-03-19,ACTUAL,2020-03-19,2020-02-19,ACTUAL,2020-02-19,,INTERVENTIONAL,HIBISCUS I,"The overall number of baseline participants (716) represents the total number enrolled (358) in this study, GA28948 (NCT02163759), plus the total number enrolled (358) in a second study of identical design, GA28949 (NCT02171429). Some of the pre-specified secondary outcome measure comparisons were planned to be evaluated by pooling data from both studies; all etrolizumab versus adalimumab comparisons and one family of etrolizumab versus placebo comparisons were evaluated on pooled data.",A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors,"Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors",COMPLETED,,PHASE3,358.0,ACTUAL,Hoffmann-La Roche,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 11:35:27.617594,2024-10-16 11:35:27.617594,INDUSTRY,,,,,,,2020,1.0
NCT04488003,,2020-07-17,2024-02-22,,2024-05-07,2020-07-24,2020-07-27,ACTUAL,2024-05-07,2024-06-04,ACTUAL,,,,2024-05-07,2024-06-04,ACTUAL,2021-01-07,ACTUAL,2021-01-07,2024-05,2024-05-31,2023-05-23,ACTUAL,2023-05-23,2023-02-15,ACTUAL,2023-02-15,,INTERVENTIONAL,,,Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations,"A Two-Part, Phase II, Multi-center Study of the ERK Inhibitor Ulixertinib (BVD-523) for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations",TERMINATED,,PHASE2,104.0,ACTUAL,"BioMed Valley Discoveries, Inc",Early termination leading to small numbers of patients analyzed.,3.0,,Enrollment challenges,t,,,,,t,f,,,,,,,,,NO,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,INDUSTRY,,NCT04566393,AVAILABLE,,,,2023,0.0
NCT03092635,,2017-03-22,,,2024-08-30,2017-03-22,2017-03-28,ACTUAL,,,,,,,2024-08-30,2024-09-04,ACTUAL,2017-06-06,ACTUAL,2017-06-06,2024-08,2024-08-31,2022-04-22,ACTUAL,2022-04-22,2021-11-10,ACTUAL,2021-11-10,,INTERVENTIONAL,,,AGE Levels in ER+ Metastatic Breast Cancer Patients Receiving Endocrine Therapy,"Pilot Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in ER+, Metastatic Breast Cancer Patients Receiving Endocrine Therapy",TERMINATED,,PHASE1,9.0,ACTUAL,Medical University of South Carolina,,1.0,,Original principal investigator departed institution and concluded the study upon departure.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,OTHER,,,,,,,2022,0.0
NCT04493151,,2020-07-27,2024-02-20,,2024-08-01,2020-07-27,2020-07-30,ACTUAL,2024-08-01,2024-08-07,ACTUAL,,,,2024-08-01,2024-08-07,ACTUAL,2021-01-01,ACTUAL,2021-01-01,2024-08,2024-08-31,2023-06-30,ACTUAL,2023-06-30,2023-05-31,ACTUAL,2023-05-31,,INTERVENTIONAL,,,Imipenem/Cilastatin/Relebactam PK in ECMO,Pharmacokinetics of Imipenem/Cilastatin/Relebactam in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation (ECMO),COMPLETED,,PHASE1,8.0,ACTUAL,Hartford Hospital,"A study limitation is the protocol defined exclusion of patients on concomitant continuous renal replacement therapy (CRRT), which is common in patients receiving ECMO (extracorporeal membrane oxygenation). Dosing modifications may be necessary in patients receiving both CRRT and ECMO.",1.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,OTHER,,,,,,,2023,1.0
NCT05788289,,2023-03-15,,,2024-08-06,2023-03-27,2023-03-28,ACTUAL,,,,,,,2024-08-06,2024-08-09,ACTUAL,2023-03-14,ACTUAL,2023-03-14,2024-08,2024-08-31,2024-08-01,ACTUAL,2024-08-01,2024-08-01,ACTUAL,2024-08-01,,INTERVENTIONAL,,,A Study of Tafasitamab and Lenalidomide in People With Mantle Cell Lymphoma,Phase 2 Study of Tafasitamab and Lenalidomide in Relapsed or Refractory Mantle Cell Lymphoma,TERMINATED,,PHASE2,4.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,Slow accrual rate,,,,,,t,f,,,,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,OTHER,,,,,,,2024,0.0
NCT00914940,,2009-06-04,2020-07-01,,2020-08-10,2009-06-04,2009-06-05,ESTIMATED,2020-08-10,2020-08-20,ACTUAL,,,,2020-08-10,2020-08-20,ACTUAL,2009-12-17,ACTUAL,2009-12-17,2020-07,2020-07-31,2020-05-26,ACTUAL,2020-05-26,2019-12-01,ACTUAL,2019-12-01,,INTERVENTIONAL,,,Selective Depletion of CD45RA+T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD,A Multi-center Phase II Study of Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD,TERMINATED,,PHASE2,41.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,Did not reach one of the primary endpoints of decreased total acute GVHD,f,,,,t,,,,,,,,,,,,,2024-10-16 11:35:27.617594,2024-10-16 11:35:27.617594,OTHER,,,,,,,2020,0.0
NCT02012296,,2013-12-10,2022-01-05,,2022-06-17,2013-12-10,2013-12-16,ESTIMATED,2022-06-17,2022-07-13,ACTUAL,,,,2022-06-17,2022-07-13,ACTUAL,2013-12-13,ACTUAL,2013-12-13,2022-06,2022-06-30,2020-08-01,ACTUAL,2020-08-01,2019-06-10,ACTUAL,2019-06-10,,INTERVENTIONAL,,,Enzalutamide and Mifepristone in Treating Patients With Metastatic Hormone Resistant Prostate Cancer,A Phase I/II Trial of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Mifepristone for Patients With Metastatic Castration Resistant Prostate Cancer (CRPC),COMPLETED,,PHASE1/PHASE2,88.0,ACTUAL,University of Chicago,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,OTHER,,,,,,,2020,1.0
NCT02538432,,2015-08-31,,,2019-10-31,2015-08-31,2015-09-02,ESTIMATED,,,,,,,2019-10-31,2019-11-04,ACTUAL,2017-06,ESTIMATED,2017-06-30,2017-06,2017-06-30,2021-12,ESTIMATED,2021-12-31,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,"Phase II Trial of EP4 Receptor Antagonist, AAT-007 (RQ-07; CJ-023,423) in Advanced Solid Tumors","15xxGCC: PHASE II TRIAL OF THE EP4 RECEPTOR ANTAGONIST, AAT-007 (RQ-07; CJ-023,423) IN ADVANCED SOLID TUMORS",WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of Maryland, Baltimore",,2.0,,PI No Longer at University of Maryland. Now at Fox Chase,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 11:35:27.617594,2024-10-16 11:35:27.617594,OTHER,,,,,,,2021,0.0
NCT04321967,,2020-03-24,,,2022-11-03,2020-03-24,2020-03-26,ACTUAL,,,,,,,2022-11-03,2022-11-08,ACTUAL,2019-08-20,ACTUAL,2019-08-20,2021-01,2021-01-31,2022-11-01,ACTUAL,2022-11-01,2022-11-01,ACTUAL,2022-11-01,,INTERVENTIONAL,,,Nitropaste in Breast Reduction,Topical Nitroglycerin as a Mechanism for Cutaneous Vaso-modulation and Improved Wound Healing After Breast Reduction,WITHDRAWN,,PHASE3,0.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,2.0,,Unable to recruit patients,f,,,,f,t,f,,,,,,,,,NO,There is not a plan to make IPD and related data dictionaries available. The PI does not plan to share data at the conclusion of the study beyond what is published,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,OTHER,,,,,,,2022,0.0
NCT02921373,,2016-09-27,,,2024-07-22,2016-09-29,2016-10-03,ESTIMATED,,,,,,,2024-07-22,2024-07-24,ACTUAL,2019-07,ESTIMATED,2019-07-31,2024-07,2024-07-31,2022-12,ESTIMATED,2022-12-31,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,TRACK,,Tracking Peripheral Blood Mononuclear Cells With Fluorine MRI,A Phase I Study Evaluating the Feasibility of Using Fluorine-19 Cell Sense to Image Human Peripheral Blood Mononuclear Cells In Vivo,WITHDRAWN,,PHASE1,0.0,ACTUAL,"Western University, Canada",,2.0,,Lack of funding,f,,,,t,t,f,,,,,,,,,NO,Only group data will be presented,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,OTHER,,,,,,,2022,0.0
NCT02926235,,2016-06-24,,,2022-08-05,2016-10-05,2016-10-06,ESTIMATED,,,,,,,2022-08-05,2022-08-08,ACTUAL,2016-04,,2016-04-30,2022-08,2022-08-31,2022-05-14,ACTUAL,2022-05-14,2022-05-14,ACTUAL,2022-05-14,,INTERVENTIONAL,Amino Acid,,Trial of Essential Amino Acid Supplementation in Protein Deficient Patients Following Total Knee Arthroplasty,Randomized Control Trial of Essential Amino Acid Supplementation in Protein Deficient Patients Following Total Knee Arthroplasty,TERMINATED,,PHASE4,50.0,ACTUAL,"Hospital for Special Surgery, New York",,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,OTHER,,,,,,,2022,0.0
NCT03665311,,2018-07-19,,,2020-06-15,2018-09-07,2018-09-11,ACTUAL,,,,,,,2020-06-15,2020-06-17,ACTUAL,2019-03-25,ACTUAL,2019-03-25,2020-06,2020-06-30,2020-01-15,ACTUAL,2020-01-15,2020-01-15,ACTUAL,2020-01-15,,INTERVENTIONAL,SAFER-SLED,,Saline Versus Albumin Fluid for Extracorporeal Removal With Slow Low Efficiency Dialysis Feasibility Study,Saline Versus Albumin Fluid for Extracorporeal Removal With Slow Low Efficiency Dialysis (SAFER-SLED): A Feasibility Study,COMPLETED,,PHASE2,60.0,ACTUAL,Ottawa Hospital Research Institute,,2.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,OTHER,,,,,,,2020,0.0
NCT05001282,,2021-07-14,,,2024-08-05,2021-08-04,2021-08-11,ACTUAL,,,,,,,2024-08-05,2024-08-07,ACTUAL,2021-09-13,ACTUAL,2021-09-13,2024-08,2024-08-31,2024-06-07,ACTUAL,2024-06-07,2024-06-07,ACTUAL,2024-06-07,,INTERVENTIONAL,,,A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα),"Dose Escalation and Expansion Clinical Study to Evaluate the Safety and Efficacy of ELU001 in Subjects Who Have Advanced, Recurrent or Refractory FRα Overexpressing Tumors",TERMINATED,,PHASE1/PHASE2,79.0,ACTUAL,Elucida Oncology,,1.0,,Lack of Funding - no safety issue with Drug; Company Permanently Closed,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2024,0.0
NCT05473234,,2022-07-11,,,2024-03-06,2022-07-22,2022-07-25,ACTUAL,,,,,,,2024-03-06,2024-03-08,ACTUAL,2022-10-06,ACTUAL,2022-10-06,2024-03,2024-03-31,2023-11-29,ACTUAL,2023-11-29,2023-11-29,ACTUAL,2023-11-29,,INTERVENTIONAL,,,"Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria","Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria",TERMINATED,,PHASE3,307.0,ACTUAL,"University of California, San Francisco",,2.0,,Study was halted due to low follow-up rates and issues with data collection,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 11:41:12.098083,2024-10-16 11:41:12.098083,OTHER,,,,,,,2023,0.0
NCT02591173,,2015-10-27,,,2021-01-08,2015-10-28,2015-10-29,ESTIMATED,,,,,,,2021-01-08,2021-01-12,ACTUAL,2016-02,ACTUAL,2016-02-29,2021-01,2021-01-31,2020-07,ACTUAL,2020-07-31,2020-07,ACTUAL,2020-07-31,,INTERVENTIONAL,,,Blood Pressure Lowering Effects of Angiotensin-(1-7) in Primary Autonomic Failure,Blood Pressure Lowering Effects of Angiotensin-(1-7) in Primary Autonomic Failure,TERMINATED,,EARLY_PHASE1,7.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,Difficulty recruiting,f,,,,t,,,,,,,,,,,,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2020,0.0
NCT05125068,,2021-11-08,,,2024-03-25,2021-11-17,2021-11-18,ACTUAL,,,,,,,2024-03-25,2024-03-26,ACTUAL,2022-03-21,ACTUAL,2022-03-21,2024-03,2024-03-31,2023-07-31,ACTUAL,2023-07-31,2023-07-31,ACTUAL,2023-07-31,,INTERVENTIONAL,,,Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN),"A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy",TERMINATED,,PHASE2,24.0,ACTUAL,Eledon Pharmaceuticals,,2.0,,An administrative decision was made to terminate the AT-1501-N205 study. This voluntary business-related decision was not related to the safety of tegoprubart (AT-1501). Available safety data demonstrated tegoprubart to be safe and well tolerated.,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2023,0.0
NCT03410693,,2018-01-19,2021-10-13,,2022-09-25,2018-01-19,2018-01-25,ACTUAL,2021-11-30,2021-12-29,ACTUAL,,,,2022-09-25,2022-09-28,ACTUAL,2018-05-31,ACTUAL,2018-05-31,2022-09,2022-09-30,2020-10-27,ACTUAL,2020-10-27,2020-10-27,ACTUAL,2020-10-27,,INTERVENTIONAL,FORT-1,,Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma,"A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy",COMPLETED,,PHASE2/PHASE3,175.0,ACTUAL,Bayer,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 11:41:12.098083,2024-10-16 11:41:12.098083,INDUSTRY,,,,,,,2020,1.0
NCT03785678,,2018-12-19,2024-02-20,,2024-05-20,2018-12-20,2018-12-24,ACTUAL,2024-05-20,2024-05-22,ACTUAL,,,,2024-05-20,2024-05-22,ACTUAL,2019-03-02,ACTUAL,2019-03-02,2024-05,2024-05-31,2023-02-28,ACTUAL,2023-02-28,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,TIMELESS,,Tenecteplase in Stroke Patients Between 4.5 and 24 Hours,"A Phase III, Prospective, Double-blind, Randomized, Placebo-controlled Trial of Thrombolysis in Imaging-eligible, Late-window Patients to Assess the Efficacy and Safety of Tenecteplase (TIMELESS)",COMPLETED,,PHASE3,458.0,ACTUAL,"Genentech, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2023,0.0
NCT02525861,,2015-08-14,2021-07-29,,2021-09-17,2015-08-14,2015-08-18,ESTIMATED,2021-09-17,2021-10-14,ACTUAL,,,,2021-09-17,2021-10-14,ACTUAL,2016-03-08,ACTUAL,2016-03-08,2021-07,2021-07-31,2020-07-29,ACTUAL,2020-07-29,2020-07-29,ACTUAL,2020-07-29,,INTERVENTIONAL,,"Safety analysis set consisted of all enrolled participants who received any amount of investigational product (IP), regardless of protocol deviations or non-adherence to study procedures.","GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study","A Phase 3/4 Study to Evaluate the Safety, Immunogenicity, and Effects on the Alpha1-Proteinase Inhibitor (A1PI) Levels in Epithelial Lining Fluid Following Glassia Therapy in A1PI-Deficient Subjects",COMPLETED,,PHASE3,34.0,ACTUAL,Takeda,,2.0,,,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2020,1.0
NCT04489420,,2020-07-22,,,2022-08-09,2020-07-24,2020-07-28,ACTUAL,,,,,,,2022-08-09,2022-08-10,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2022-08,2022-08-31,2021-08-10,ACTUAL,2021-08-10,2021-08-10,ACTUAL,2021-08-10,,INTERVENTIONAL,CYNK001GBM01,,Natural Killer Cell (CYNK-001) IV Infusion or IT Administration in Adults With Recurrent GBM,A Phase I Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) in Adults With Recurrent Glioblastoma Multiforme (GBM),TERMINATED,,PHASE1,3.0,ACTUAL,Celularity Incorporated,,2.0,,Business decision.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 15:12:37.017388,2024-10-15 15:12:37.017388,INDUSTRY,,,,,,,2021,0.0
NCT03051516,,2017-02-09,2023-12-15,,2024-01-31,2017-02-09,2017-02-13,ACTUAL,2024-01-31,2024-02-28,ACTUAL,,,,2024-01-31,2024-02-28,ACTUAL,2017-08-01,ACTUAL,2017-08-01,2024-01,2024-01-31,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,Participants who have completed Enrollment Visit and had at least 30 days follow-up after the initial dose of vaccine (n=185) were included in the intention-to-treat analysis and are considered part of the Baseline Analysis Population. Three participants (2 in Arm I/vaccine and 1 in Arm II/placebo) were excluded from analysis due to completing only one vaccination before study exit.,HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions,"HPV Vaccine to Interrupt Progression of Vulvar and Anal Neoplasia (VIVA) Trial: A Randomized, Double-Blind, Placebo-Controlled Trial",TERMINATED,,PHASE4,188.0,ACTUAL,Fred Hutchinson Cancer Center,"An interim analysis found the intervention to be futile. Therefore, the VIVA trial was ended effective July 31st, 2022, for the University of Washington clinic, and December 31st, 2022, for the University of Alabama Birmingham clinic. Participants were offered the choice of continuing any outstanding visits until the end of the study at the respective sites.",2.0,,The study was terminated early due to futility.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,OTHER,,,,,,,2022,0.0
NCT05232123,,2022-01-11,,,2024-03-26,2022-02-07,2022-02-09,ACTUAL,,,,,,,2024-03-26,2024-03-27,ACTUAL,2023-07,ESTIMATED,2023-07-31,2024-03,2024-03-31,2024-12,ESTIMATED,2024-12-31,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Cannabidiol Effects on Cardiovascular System and Exercise Responses,Cannabidiol Effects on Cardiovascular System and Exercise Responses,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Castleton University,,4.0,,did not receive funding,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,OTHER,,,,,,,2024,0.0
NCT04264819,,2020-02-07,,,2023-07-07,2020-02-07,2020-02-11,ACTUAL,,,,,,,2023-07-07,2023-07-10,ACTUAL,2020-12-14,ACTUAL,2020-12-14,2023-07,2023-07-31,2023-05-10,ACTUAL,2023-05-10,2022-10-05,ACTUAL,2022-10-05,,INTERVENTIONAL,SWIFT,,Study of Brolucizumab in Adult Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration,"A One-year, Single-arm, Open-label, Multicenter Study Assessing the Effect of Brolucizumab on Disease Control in Adult Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration (SWIFT)",COMPLETED,,PHASE3,295.0,ACTUAL,Novartis,,1.0,,,f,,,,f,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2023,1.0
NCT05010954,,2021-08-11,,,2023-04-23,2021-08-11,2021-08-18,ACTUAL,,,,,,,2023-04-23,2023-04-25,ACTUAL,2021-10-18,ACTUAL,2021-10-18,2023-04,2023-04-30,2022-09-28,ACTUAL,2022-09-28,2022-09-28,ACTUAL,2022-09-28,,INTERVENTIONAL,,,Efficacy and Safety of LXI-15028 Comparing With Lansoprazole in the Treatment of Duodenal Ulcer,"A Multi-center, Randomized, Double-blind, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of LXI-15028 Compared to Lansoprazole in the Treatment of Duodenal Ulcer in Chinese Patients for up to 6 Weeks",COMPLETED,,PHASE3,400.0,ACTUAL,"Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.",,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2022,1.0
NCT04895046,,2021-05-17,,,2022-06-23,2021-05-17,2021-05-20,ACTUAL,,,,,,,2022-06-23,2022-06-29,ACTUAL,2021-10-11,ACTUAL,2021-10-11,2022-06,2022-06-30,2023-09,ESTIMATED,2023-09-30,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma,"Molecularly Driven, Immune-Based, Maintenance Niraparib and Dostarlimab in Advanced Stage Cholangiocarcinoma",WITHDRAWN,,PHASE2,0.0,ACTUAL,Hoosier Cancer Research Network,,1.0,,Funder decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 11:41:12.098083,2024-10-16 11:41:12.098083,OTHER,,,,,,,2023,0.0
NCT04331054,,2020-03-29,,,2021-07-31,2020-04-01,2020-04-02,ACTUAL,,,,,,,2021-07-31,2021-08-03,ACTUAL,2020-04-13,ACTUAL,2020-04-13,2021-07,2021-07-31,2021-05-28,ACTUAL,2021-05-28,2021-05-28,ACTUAL,2021-05-28,,INTERVENTIONAL,INHASCO,,Protective Role of Inhaled Steroids for Covid-19 Infection,Protective Role of Inhaled Steroids for Covid-19 Infection,TERMINATED,,PHASE3,146.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,Insufficient recruitment,f,,,,t,f,f,,,,,,,,,,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,OTHER,,,,,,,2021,0.0
NCT04412538,,2020-05-21,,,2023-10-08,2020-06-01,2020-06-02,ACTUAL,,,,,,,2023-10-08,2023-10-11,ACTUAL,2020-05-15,ACTUAL,2020-05-15,2023-10,2023-10-31,2021-08-31,ACTUAL,2021-08-31,2020-08-10,ACTUAL,2020-08-10,,INTERVENTIONAL,,,Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19,"A Randomized, Double-blind, Placebo-controlled, Phase Ia/IIa Trial of an Inactivated SARS-CoV-2 Vaccine in Healthy People Aged 18 to 59 Years",COMPLETED,,PHASE1/PHASE2,942.0,ACTUAL,"Institute of Medical Biology, Chinese Academy of Medical Sciences",,8.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,OTHER,,,,,,,2021,1.0
NCT05607342,,2022-10-31,,,2024-02-19,2022-10-31,2022-11-07,ACTUAL,,,,,,,2024-02-19,2024-02-21,ACTUAL,2023-01-03,ACTUAL,2023-01-03,2024-02,2024-02-29,2023-11-06,ACTUAL,2023-11-06,2023-09-22,ACTUAL,2023-09-22,,INTERVENTIONAL,PORT-MAP,,Pilot of Osanetant to Reduce Testosterone in Men With Adenocarcinoma of the Prostate,Pilot of Osanetant to Reduce Testosterone in Men With Adenocarcinoma of the Prostate (PORT-MAP),TERMINATED,,EARLY_PHASE1,1.0,ACTUAL,University of Kansas Medical Center,,1.0,,Development of the drug program has been discontinued,f,,,,,t,f,,,,,,,,,,,2024-10-16 11:41:12.098083,2024-10-16 11:41:12.098083,OTHER,,,,,,,2023,0.0
NCT03015792,,2017-01-04,,,2023-03-03,2017-01-06,2017-01-10,ESTIMATED,,,,,,,2023-03-03,2023-03-07,ACTUAL,2017-03-10,ACTUAL,2017-03-10,2023-02,2023-02-28,2022-10-18,ACTUAL,2022-10-18,2022-10-18,ACTUAL,2022-10-18,,INTERVENTIONAL,,,"Ibrutinib, Lenalidomide, and Dexamethasone in Treating Patients With Multiple Myeloma Ineligible for Transplant","Phase I/II Trial of Ibrutinib, Dexamethasone, and Lenalidomide as Initial Therapy for Transplant Ineligible Multiple Myeloma Patients",TERMINATED,,PHASE1/PHASE2,18.0,ACTUAL,Mayo Clinic,,1.0,,Per CS0139535 -submitter stated we can update status to Admin complete- low accrual reasoning,f,,,,t,t,f,,,,,,,,,,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,OTHER,,,,,,,2022,0.0
NCT04042740,,2019-07-31,2024-05-15,,2024-07-02,2019-07-31,2019-08-02,ACTUAL,2024-07-02,2024-07-11,ACTUAL,,,,2024-07-02,2024-07-11,ACTUAL,2019-11-20,ACTUAL,2019-11-20,2024-07,2024-07-31,2023-08-22,ACTUAL,2023-08-22,2023-05-18,ACTUAL,2023-05-18,,INTERVENTIONAL,PURGE-C,All eligible participants who initiated study treatment,Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection,Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C),COMPLETED,,PHASE2,45.0,ACTUAL,Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections,,1.0,,,f,,,,t,t,f,,,t,,,Beginning 3 months following publication and throughout period of funding of the ACTG Network by NIH.,* With whom?~  * Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses?~  * To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism will data be made available?~  * Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at: https://actgnetwork.org/about-actg/templates-and-forms. Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data.,,YES,"Individual participant data that underlie results in the publication, after deidentification.",2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,NETWORK,,,,,,,2023,1.0
NCT02560935,,2015-09-02,,,2020-07-31,2015-09-24,2015-09-25,ESTIMATED,,,,,,,2020-07-31,2020-08-03,ACTUAL,2016-07-19,ACTUAL,2016-07-19,2020-07,2020-07-31,2020-03-03,ACTUAL,2020-03-03,2020-03-03,ACTUAL,2020-03-03,,INTERVENTIONAL,SPRING,,Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II,Primary Prevention of Stroke in Children With Sickle Cell Disease in Sub-Saharan Africa II,COMPLETED,,PHASE3,440.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 15:18:40.354512,2024-10-15 15:18:40.354512,OTHER,,,,,,,2020,0.0
NCT05687903,,2023-01-09,,,2024-01-25,2023-01-09,2023-01-18,ACTUAL,,,,,,,2024-01-25,2024-01-26,ACTUAL,2023-01-09,ACTUAL,2023-01-09,2024-01,2024-01-31,2023-12-14,ACTUAL,2023-12-14,2023-12-14,ACTUAL,2023-12-14,,INTERVENTIONAL,,,A Study of TAK-861 in Participants With Narcolepsy Type 1,"A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)",COMPLETED,,PHASE2,112.0,ACTUAL,Takeda,,5.0,,,f,,,,t,t,f,,,f,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2023,1.0
NCT03715153,,2018-10-12,2022-10-26,,2023-05-09,2018-10-18,2018-10-23,ACTUAL,2023-05-09,2023-06-05,ACTUAL,,,,2023-05-09,2023-06-05,ACTUAL,2018-10-04,ACTUAL,2018-10-04,2023-05,2023-05-31,2021-10-26,ACTUAL,2021-10-26,2021-10-26,ACTUAL,2021-10-26,,INTERVENTIONAL,,,Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.,"Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder. A 6-month Randomised, Double-blind, Placebo Controlled Multicentre Parallel Group Study to Evaluate Efficacy and Safety of Bumetanide 0.5mg Twice a Day Followed by an Open Label Active 6-month Treatment Period With Bumetanide (0.5mg Twice a Day) and a 6 Weeks Discontinuation Period After Treatment Stop.",TERMINATED,,PHASE3,211.0,ACTUAL,Servier,The sponsor decided to stop the S95008 development and prematurely discontinue the extension period. This decision was not related to unexpected safety concerns.,2.0,,The 6-month efficacy analysis did not show any significant difference between bumetanide versus placebo in the treatment of ASD in the overall studied population. No unexpected safety concerns were identified.,f,,,,t,t,f,,,,,,After Marketing Authorisation in EEA or US if the study is used for the approval.,Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.,https://clinicaltrials.servier.com/,YES,"Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.",2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2021,0.0
NCT04603365,,2020-10-21,,,2023-05-15,2020-10-21,2020-10-26,ACTUAL,,,,,,,2023-05-15,2023-05-17,ACTUAL,2021-10-18,ACTUAL,2021-10-18,2022-10,2022-10-31,2023-05-07,ACTUAL,2023-05-07,2023-05-07,ACTUAL,2023-05-07,,INTERVENTIONAL,,,Pamiparib and Temozolomide for the Treatment of Hereditary Leiomyomatosis and Renal Cell Cancer,A Phase 2 Study of Pamiparib (BGB-290) Plus Temozolomide for Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC),WITHDRAWN,,PHASE2,0.0,ACTUAL,Jonsson Comprehensive Cancer Center,,1.0,,enrollment,,,,,t,t,f,,,f,,,,,,,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,OTHER,,,,,,,2023,0.0
NCT04919096,,2021-05-18,,,2022-04-12,2021-06-02,2021-06-09,ACTUAL,,,,,,,2022-04-12,2022-04-19,ACTUAL,2022-04,ESTIMATED,2022-04-30,2022-04,2022-04-30,2023-01,ESTIMATED,2023-01-31,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,Study of SCB-420 in Subjects With Neovascular Age-related Macular Degeneration,"A Phase 1, Randomized, Double-Masked, Parallel Group, Multicenter, Pilot Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SCB-420 and Eylea® in Subjects With Neovascular Age-related Macular Degeneration",WITHDRAWN,,PHASE1,0.0,ACTUAL,Clover Biopharmaceuticals AUS Pty Ltd,,2.0,,"Due to an internal decision to prioritise its development pipeline, Clover have decided to close down study CLO-SCB-420-001. This was a corporate decision and not the results of new data or information arising related to SCB-420",f,,,,f,f,f,,,f,,,,,,,,2024-10-15 01:31:56.588757,2024-10-15 01:31:56.588757,INDUSTRY,,,,,,,2023,0.0
NCT03693846,,2018-10-01,2022-05-03,,2022-09-26,2018-10-02,2018-10-03,ACTUAL,2022-09-26,2022-10-20,ACTUAL,,,,2022-09-26,2022-10-20,ACTUAL,2019-02-15,ACTUAL,2019-02-15,2022-09,2022-09-30,2021-03-06,ACTUAL,2021-03-06,2021-03-06,ACTUAL,2021-03-06,,INTERVENTIONAL,,,Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors,A Phase II Study of Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors,TERMINATED,,PHASE2,11.0,ACTUAL,Abramson Cancer Center at Penn Medicine,Early termination leading to small numbers of subjects analyzed.,1.0,,Terminated due to slow enrollment and lack of efficacy,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 11:41:12.098083,2024-10-16 11:41:12.098083,OTHER,,,,,,,2021,0.0
NCT03302221,,2017-10-01,,,2020-03-06,2017-10-03,2017-10-05,ACTUAL,,,,,,,2020-03-06,2020-03-10,ACTUAL,2017-10-15,ACTUAL,2017-10-15,2020-03,2020-03-31,2020-09-20,ESTIMATED,2020-09-20,2020-08-20,ESTIMATED,2020-08-20,,INTERVENTIONAL,,,Regional Haemodynamic Changes in Radial Artery Assessment With Continuous Pulsed-wave Doppler Ultrasound,Regional Haemodynamic Changes in Radial Artery Assessment With Continuous Pulsed-wave Doppler Ultrasound in Patients Undergoing Video-assisted Thoracic Surgery With Different Kinds of Anaesthesia Management,WITHDRAWN,,PHASE4,0.0,ACTUAL,"China Medical University, China",,3.0,,No participants enrolled,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 11:41:12.098083,2024-10-16 11:41:12.098083,OTHER,,,,,,,2020,0.0
NCT03999658,,2019-06-24,,,2023-04-27,2019-06-26,2019-06-27,ACTUAL,,,,,,,2023-04-27,2023-05-01,ACTUAL,2023-03,ESTIMATED,2023-03-31,2023-04,2023-04-30,2024-07,ESTIMATED,2024-07-31,2024-01,ESTIMATED,2024-01-31,,INTERVENTIONAL,,,A Study of STI-3031 (an Anti-PD-L1 Antibody) in Patients With Selected Relapsed/Refractory Malignancies,"An Open-label, Multicenter, Global Phase 2 Basket Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of STI-3031 in Patients With Selected Relapsed or Refractory Malignancies.",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,4.0,,Sorrento Therapeutics filed for chapter 11 bankruptcy.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2024,0.0
NCT04023721,,2019-06-21,,,2020-07-20,2019-07-16,2019-07-17,ACTUAL,,,,,,,2020-07-20,2020-07-22,ACTUAL,2019-06-18,ACTUAL,2019-06-18,2020-07,2020-07-31,2020-07-16,ACTUAL,2020-07-16,2020-07-16,ACTUAL,2020-07-16,,INTERVENTIONAL,,,"Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic, Hepatitis B e Antigen-negative Subjects Infected With HBV Virus and Receiving or Stopping Treatment With a NUC Inhibitor","A Phase 2, Exploratory Study Evaluating the Safety and Antiviral Efficacy of Inarigivir Soproxil in Non-cirrhotic, Hepatitis B e Antigen-negative Subjects Infected With Chronic Hepatitis B Virus and Receiving or Stopping Treatment With a Nucleoside/Nucleotide Inhibitor",TERMINATED,,PHASE2,64.0,ACTUAL,"F-star Therapeutics, Inc.",,3.0,,Safety,f,,,,,f,f,,,,,,,,,,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2020,0.0
NCT02678143,,2016-02-04,,,2022-01-28,2016-02-04,2016-02-09,ESTIMATED,,,,,,,2022-01-28,2022-02-14,ACTUAL,2016-04-26,ACTUAL,2016-04-26,2022-01,2022-01-31,2021-11-16,ACTUAL,2021-11-16,2020-04-03,ACTUAL,2020-04-03,,INTERVENTIONAL,,,Nonmyeloablative Conditioning for Mismatched Hematopoietic Stem Cell Transplantation for Severe Sickle Cell Disease,A Pilot Study of Nonmyeloablative Conditioning for Mismatched Hematopoietic Stem Cell Transplantation for Severe Sickle Cell Disease,TERMINATED,,PHASE1,1.0,ACTUAL,Washington University School of Medicine,,1.0,,Closed early due to competing studies,f,,,,t,t,t,,,f,,,,,,NO,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,OTHER,,,,,,,2021,0.0
NCT02108964,,2014-04-07,2020-10-01,2018-10-01,2023-09-04,2014-04-07,2014-04-09,ESTIMATED,2020-10-01,2020-10-26,ACTUAL,2018-10-01,2018-10-04,ACTUAL,2023-09-04,2023-09-07,ACTUAL,2014-06-06,ACTUAL,2014-06-06,2023-09,2023-09-30,2023-08-15,ACTUAL,2023-08-15,2018-03-22,ACTUAL,2018-03-22,,INTERVENTIONAL,,,"A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies","A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies",COMPLETED,,PHASE1/PHASE2,225.0,ACTUAL,Novartis,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2023,1.0
NCT04853355,,2021-04-20,,,2022-07-28,2021-04-20,2021-04-21,ACTUAL,,,,,,,2022-07-28,2022-08-02,ACTUAL,2022-07,ESTIMATED,2022-07-31,2022-04,2022-04-30,2022-10,ESTIMATED,2022-10-31,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,Non-Responsive Diabetic Macular Edema and Spironolactone,Non-Responsive Diabetic Macular Edema in Patients With Pachychoroid and Choroidal Hyperpermeability.,WITHDRAWN,,PHASE4,0.0,ACTUAL,Wake Forest University Health Sciences,,1.0,,lack of funding,f,,,,f,t,f,,,f,,,12 months after completion date,Contact Principal investigator,,YES,Available upon request.,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,OTHER,,,,,,,2022,0.0
NCT03112720,,2014-09-03,2021-11-10,,2023-06-15,2017-04-07,2017-04-13,ACTUAL,2023-06-15,2023-06-22,ACTUAL,,,,2023-06-15,2023-06-22,ACTUAL,2016-09,,2016-09-30,2023-06,2023-06-30,2020-09,ACTUAL,2020-09-30,2020-09,ACTUAL,2020-09-30,,INTERVENTIONAL,,,Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache,A Comparison of the Efficacy of Sphenopalatine Ganglion (SPG) Block With 5% Lidocaine Versus Epidural Blood Patch (EBP) for the Treatment of Post-Dural Puncture Headache (PDPH),TERMINATED,,PHASE3,8.0,ACTUAL,"Rutgers, The State University of New Jersey",,2.0,,no enrollment after covid pandemic,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 11:41:12.098083,2024-10-16 11:41:12.098083,OTHER,,,,,,,2020,0.0
NCT02606461,,2015-10-13,2021-11-08,,2023-01-05,2015-11-13,2015-11-17,ESTIMATED,2021-11-08,2021-12-07,ACTUAL,,,,2023-01-05,2023-01-23,ACTUAL,2016-01-04,ACTUAL,2016-01-04,2023-01,2023-01-31,2021-10-26,ACTUAL,2021-10-26,2020-10-28,ACTUAL,2020-10-28,,INTERVENTIONAL,SEAL,,Selinexor in Advanced Liposarcoma,"A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)",COMPLETED,,PHASE2/PHASE3,342.0,ACTUAL,Karyopharm Therapeutics Inc,,4.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2021,1.0
NCT00433342,,2007-02-07,,,2020-04-23,2007-02-08,2007-02-09,ESTIMATED,,,,,,,2020-04-23,2020-04-27,ACTUAL,2006-03,,2006-03-31,2020-04,2020-04-30,2020-04,ACTUAL,2020-04-30,2020-04,ACTUAL,2020-04-30,,INTERVENTIONAL,,,The Effect of Antimicrobial Therapy on the Serum Level of P-cresol in Peritoneal Dialysis Patients,Study on the Effect of Flucloxacillin on the Serum Level of P-cresol in Peritoneal Dialysis Patients,TERMINATED,,PHASE1,9.0,ACTUAL,Universitaire Ziekenhuizen KU Leuven,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,OTHER,,,,,,,2020,0.0
NCT04140279,,2019-10-24,,,2024-02-29,2019-10-24,2019-10-25,ACTUAL,,,,,,,2024-02-29,2024-03-04,ACTUAL,2022-05-13,ESTIMATED,2022-05-13,2024-02,2024-02-29,2023-08,ESTIMATED,2023-08-31,2023-08,ESTIMATED,2023-08-31,,INTERVENTIONAL,,,A Study to Evaluate the Effect of Latanoprostene Bunod Ophthalmic Solution 0.024% on Episcleral Venous Pressure and Outflow Facility in Participants With Ocular Hypertension,Effect of Latanoprostene Bunod Ophthalmic Solution 0.024% on Episcleral Venous Pressure and Outflow Facility in Ocular Hypertensive Subjects,WITHDRAWN,,PHASE4,0.0,ACTUAL,Bausch & Lomb Incorporated,,2.0,,It never started,f,,,,,t,f,,,,,,,,,,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2023,0.0
NCT03535194,,2018-05-14,2021-03-03,,2021-03-03,2018-05-14,2018-05-24,ACTUAL,2021-03-03,2021-03-30,ACTUAL,,,,2021-03-03,2021-03-30,ACTUAL,2018-06-26,ACTUAL,2018-06-26,2020-08,2020-08-31,2020-06-03,ACTUAL,2020-06-03,2020-03-05,ACTUAL,2020-03-05,,INTERVENTIONAL,,,A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2),"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-2",COMPLETED,,PHASE3,1484.0,ACTUAL,Eli Lilly and Company,,5.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,INDUSTRY,,,,,,,2020,1.0
NCT03640481,,2018-08-13,,,2023-12-15,2018-08-17,2018-08-21,ACTUAL,,,,,,,2023-12-15,2023-12-21,ACTUAL,2018-10-11,ACTUAL,2018-10-11,2023-12,2023-12-31,2023-12-11,ACTUAL,2023-12-11,2023-12-11,ACTUAL,2023-12-11,,INTERVENTIONAL,,,Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy,"A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy (The ROCKstar Study)",TERMINATED,,PHASE2,159.0,ACTUAL,Sanofi,,2.0,,The sponsor has decided to prematurely terminate the study due to the challenges encountered in recruiting adolescent participants. This decision was made without any safety concerns.,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.",2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2023,0.0
NCT03870529,,2019-03-08,2023-11-20,,2023-12-19,2019-03-08,2019-03-12,ACTUAL,2023-12-19,2024-01-09,ACTUAL,,,,2023-12-19,2024-01-09,ACTUAL,2019-08-19,ACTUAL,2019-08-19,2023-12,2023-12-31,2022-12-09,ACTUAL,2022-12-09,2022-12-09,ACTUAL,2022-12-09,,INTERVENTIONAL,,,High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer,A Pilot Study of Neoadjuvant High Dose Vitamin A for Resectable Non-Small Cell Lung Cancer,TERMINATED,,EARLY_PHASE1,20.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,Slow accruals,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,OTHER,,,,,,,2022,0.0
NCT04588727,,2020-10-09,,,2023-12-15,2020-10-09,2020-10-19,ACTUAL,,,,,,,2023-12-15,2023-12-18,ACTUAL,2020-10-15,ACTUAL,2020-10-15,2023-12,2023-12-31,2022-01-19,ACTUAL,2022-01-19,2022-01-19,ACTUAL,2022-01-19,,INTERVENTIONAL,,,"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AZD3366 in Healthy Subjects, Japanese and Chinese Subjects","A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3366 in Healthy Men and Women of Non-Childbearing Potential Following: Part A: Single Ascending Dose Administration (Including Populations of Japanese and Chinese Subjects) Part B: Single Dose Administration of AZD3366 at One Dose Level or Placebo With Concomitant Repeated Dosing of Ticagrelor and Acetylsalicylic Acid",COMPLETED,,PHASE1,103.0,ACTUAL,AstraZeneca,,10.0,,,f,,,,f,t,f,,,f,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please re-refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,INDUSTRY,,,,,,,2022,1.0
NCT02464228,,2015-06-03,2024-04-18,,2024-05-31,2015-06-04,2015-06-08,ESTIMATED,2024-05-31,2024-06-26,ACTUAL,,,,2024-05-31,2024-06-26,ACTUAL,2016-02-25,ACTUAL,2016-02-25,2024-04,2024-04-30,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,PTCL,The All Subjects as Treated (ASaT) Population consists of all enrolled subjects who received at least 1 dose of tipifarnib.,Investigation of Tipifarnib in Treatment of Subjects With Peripheral T-Cell Lymphoma (PTCL) That Have Not Responded to Standard Therapy,An Open Label Phase II Study of Tipifarnib in Subjects With Relapsed or Refractory Peripheral T-Cell Lymphoma,COMPLETED,,PHASE2,65.0,ACTUAL,"Kura Oncology, Inc.",,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2021,1.0
NCT06369077,,2024-04-12,,,2024-08-21,2024-04-12,2024-04-16,ACTUAL,,,,,,,2024-08-21,2024-08-23,ACTUAL,2024-04-22,ACTUAL,2024-04-22,2024-08,2024-08-31,2024-07-30,ACTUAL,2024-07-30,2024-07-30,ACTUAL,2024-07-30,,INTERVENTIONAL,,,How Much Does Reduced Dosing of Latanoprost and Dorzolamide-timolol Affect Pressure?,Cross-over Comparison of Latanoprost QOD With Dor-tim QAM to Tim-brim-dor-bim(Atoprost) qd or Lat QD With Dor-tim BID,TERMINATED,,PHASE4,36.0,ACTUAL,CT Glaucoma Associates,,2.0,,The 95% confidence interval for non-inferiority was met before planned enrollment was reached.,f,,,,,t,f,,,t,,,,,,NO,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2024,0.0
NCT04516291,,2020-08-13,2022-09-06,,2022-09-06,2020-08-13,2020-08-18,ACTUAL,2022-09-06,2022-10-04,ACTUAL,,,,2022-09-06,2022-10-04,ACTUAL,2020-09-28,ACTUAL,2020-09-28,2022-09,2022-09-30,2021-12-06,ACTUAL,2021-12-06,2021-09-29,ACTUAL,2021-09-29,,INTERVENTIONAL,,Baseline analysis population included all randomized participants.,A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70),"A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of Vupanorsen (PF-07285557) in Statin-Treated Participants With Dyslipidemia",COMPLETED,,PHASE2,286.0,ACTUAL,Pfizer,,8.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 11:41:12.098083,2024-10-16 11:41:12.098083,INDUSTRY,,,,,,,2021,1.0
NCT03548987,,2018-05-25,2021-02-19,,2022-01-07,2018-05-25,2018-06-07,ACTUAL,2021-02-19,2021-03-15,ACTUAL,,,,2022-01-07,2022-01-19,ACTUAL,2018-06-04,ACTUAL,2018-06-04,2022-01,2022-01-31,2020-03-20,ACTUAL,2020-03-20,2020-02-22,ACTUAL,2020-02-22,,INTERVENTIONAL,STEP 4,Full analysis set (FAS) included all randomised participants.,Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity,Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity Who Have Reached Target Dose During run-in Period,COMPLETED,,PHASE3,902.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com/sharing-results,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 02:06:43.477233,2024-10-16 02:06:43.477233,INDUSTRY,,,,,,,2020,1.0
NCT04939662,,2021-06-02,,,2023-12-29,2021-06-16,2021-06-25,ACTUAL,,,,,,,2023-12-29,2024-01-02,ACTUAL,2021-06-11,ACTUAL,2021-06-11,2023-12,2023-12-31,2023-10-27,ACTUAL,2023-10-27,2023-10-27,ACTUAL,2023-10-27,,INTERVENTIONAL,SUKSES-B2,,Olaparib and Bevacizumab in Relapsed Small Cell Lung Cancer Subjects,"Phase II, Single-arm Study of Olaparib and Bevacizumab Combination Therapy in Relapsed Small Cell Lung Cancer Subjects With DNA Damage Response and the Repair Pathway Alteration, ATM Deficiency, SLFN11 Positive, or POU2F3 Positive",COMPLETED,,PHASE2,25.0,ACTUAL,Samsung Medical Center,,1.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,OTHER,,,,,,,2023,1.0
NCT04989972,,2021-07-12,,,2022-06-25,2021-07-30,2021-08-04,ACTUAL,,,,,,,2022-06-25,2022-06-30,ACTUAL,2022-09-15,ESTIMATED,2022-09-15,2021-06,2021-06-30,2023-08-31,ESTIMATED,2023-08-31,2023-06-20,ESTIMATED,2023-06-20,,INTERVENTIONAL,,,Assessing the Efficacy of Micro-dosed Psilocybin on Reducing Anxiety & Depression Levels in Adults,Randomized Double Blind Placebo Controlled Assessing the Efficacy of Micro-dosed Psilocybin in Reducing Anxiety and or Depression Levels in Adults,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Wake Network, Inc.",,3.0,,GCP VIOLATIONS FROM THE SPONSORS,f,,,,t,f,f,,,,,,,,,NO,The data will be made available through publications and conference presentations,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,NETWORK,,,,,,,2023,0.0
NCT03804515,,2019-01-11,,,2021-06-14,2019-01-11,2019-01-15,ACTUAL,,,,,,,2021-06-14,2021-06-15,ACTUAL,2019-06-25,ACTUAL,2019-06-25,2021-06,2021-06-30,2020-06-17,ACTUAL,2020-06-17,2020-02-20,ACTUAL,2020-02-20,,INTERVENTIONAL,,,A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib,A Phase 1 Study for the Evaluation of Excretion (Mass Balance) and Pharmacokinetics of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib,TERMINATED,,PHASE1,2.0,ACTUAL,"Spectrum Pharmaceuticals, Inc",,1.0,,COVID,f,,,,f,t,f,,,,,,,,,,,2024-10-15 15:18:40.354512,2024-10-15 15:18:40.354512,INDUSTRY,,,,,,,2020,0.0
NCT03874325,,2019-03-12,2021-11-18,,2022-05-27,2019-03-13,2019-03-14,ACTUAL,2021-12-15,2022-01-11,ACTUAL,,,,2022-05-27,2022-05-31,ACTUAL,2019-04-26,ACTUAL,2019-04-26,2022-05,2022-05-31,2021-01-06,ACTUAL,2021-01-06,2020-11-15,ACTUAL,2020-11-15,,INTERVENTIONAL,,Study terminated early and did not go beyond Safety run in,Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer,A Phase II Trial With Safety Run-in of Neoadjuvant Therapy With an Aromatase Inhibitor in Combination With Durvalumab (MEDI4736) in Postmenopausal Patients With Hormone-Receptor-Positive Breast Cancer,TERMINATED,,PHASE2,17.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,2.0,,lost funding,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,OTHER,,,,,,,2021,0.0
NCT04344041,,2020-04-09,,,2021-04-29,2020-04-09,2020-04-14,ACTUAL,,,,,,,2021-04-29,2021-04-30,ACTUAL,2020-04-15,ACTUAL,2020-04-15,2021-04,2021-04-30,2021-01-14,ACTUAL,2021-01-14,2021-01-14,ACTUAL,2021-01-14,,INTERVENTIONAL,,,COvid-19 and Vitamin D Supplementation: a Multicenter Randomized Controlled Trial of High Dose Versus Standard Dose Vitamin D3 in High-risk COVID-19 Patients (CoVitTrial),COvid-19 and Vitamin D Supplementation: a Multicenter Randomized Controlled Trial of High Dose Versus Standard Dose Vitamin D3 in High-risk COVID-19 Patients (CoVitTrial),COMPLETED,,PHASE3,260.0,ACTUAL,"University Hospital, Angers",,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 15:18:40.354512,2024-10-15 15:18:40.354512,OTHER_GOV,,,,,,,2021,1.0
NCT04361214,,2020-04-22,,,2024-02-05,2020-04-22,2020-04-24,ACTUAL,,,,,,,2024-02-05,2024-02-07,ACTUAL,2020-05-05,ACTUAL,2020-05-05,2024-02,2024-02-29,2022-01-31,ACTUAL,2022-01-31,2022-01-31,ACTUAL,2022-01-31,,INTERVENTIONAL,,,Leflunomide in Mild COVID-19 Patients,Leflunomide for the Treatment of Ambulatory Patients With Mild COVID-19,TERMINATED,,PHASE1,11.0,ACTUAL,University of Chicago,,1.0,,Terminated by PI,f,,,,,t,f,,,t,,,,,,NO,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,OTHER,,,,,,,2022,0.0
NCT04338828,,2020-04-05,,,2021-12-15,2020-04-05,2020-04-08,ACTUAL,,,,,,,2021-12-15,2022-01-06,ACTUAL,2020-04-18,ACTUAL,2020-04-18,2021-12,2021-12-31,2021-03-01,ACTUAL,2021-03-01,2021-01-14,ACTUAL,2021-01-14,,INTERVENTIONAL,NO COV-ED,,Nitric Oxide Inhalation Therapy for COVID-19 Infections in the ED,Nitric Oxide Inhalation Therapy for COVID-19 Infections in the Emergency Department,TERMINATED,,PHASE2,47.0,ACTUAL,Massachusetts General Hospital,,2.0,,Absence of patients meeting criteria following initial COVID surge. DMSB recommended analysis of results to date and early closure.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,OTHER,,,,,,,2021,0.0
NCT04446182,,2020-06-22,2023-07-10,,2024-01-18,2020-06-22,2020-06-24,ACTUAL,2024-01-18,2024-01-22,ACTUAL,,,,2024-01-18,2024-01-22,ACTUAL,2021-01-29,ACTUAL,2021-01-29,2024-01,2024-01-31,2023-01-30,ACTUAL,2023-01-30,2022-03-29,ACTUAL,2022-03-29,,INTERVENTIONAL,FLIGHT,,Itacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic GVHD,A Phase II Study of Itacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic Graft Versus Host Disease (GVHD),TERMINATED,,PHASE2,3.0,ACTUAL,University of Utah,,1.0,,PI left institution,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 11:41:12.098083,2024-10-16 11:41:12.098083,OTHER,,,,,,,2023,0.0
NCT03840148,,2019-02-06,2024-03-23,2022-12-08,2024-05-01,2019-02-12,2019-02-15,ACTUAL,2024-05-01,2024-05-29,ACTUAL,,2024-05-29,ACTUAL,2024-05-01,2024-05-29,ACTUAL,2019-08-07,ACTUAL,2019-08-07,2024-03,2024-03-31,2021-12-14,ACTUAL,2021-12-14,2021-12-14,ACTUAL,2021-12-14,,INTERVENTIONAL,CERTAIN-1,Intent-to-treat (ITT) population: all randomized patients,Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections,"A Phase 3, Randomized, Double-blind, Active Controlled Noninferiority Study Evaluating the Efficacy, Safety, and Tolerability of Cefepime/VNRX-5133 in Adults With Complicated Urinary Tract Infections (cUTI), Including Acute Pyelonephritis",COMPLETED,,PHASE3,661.0,ACTUAL,"Venatorx Pharmaceuticals, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,INDUSTRY,,,,,,,2021,1.0
NCT02654223,,2015-12-22,,,2022-01-12,2016-01-11,2016-01-13,ESTIMATED,,,,,,,2022-01-12,2022-01-27,ACTUAL,2015-12-30,ACTUAL,2015-12-30,2022-01,2022-01-31,2021-11,ACTUAL,2021-11-30,2021-11,ACTUAL,2021-11-30,,INTERVENTIONAL,MG56,,Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy,"Double Blind, Placebo-controlled, Dose Finding, Prospective, Multicenter Clinical Trial for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy",COMPLETED,,PHASE2,180.0,ACTUAL,Inmunotek S.L.,,9.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 15:18:40.354512,2024-10-15 15:18:40.354512,INDUSTRY,,,,,,,2021,1.0
NCT04909879,,2021-05-29,,,2021-09-17,2021-05-29,2021-06-02,ACTUAL,,,,,,,2021-09-17,2021-09-24,ACTUAL,2021-09,ESTIMATED,2021-09-30,2021-09,2021-09-30,2022-04,ESTIMATED,2022-04-30,2022-02,ESTIMATED,2022-02-28,,INTERVENTIONAL,,,Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome,Treatment of Non-COVID-19 Acute Respiratory Distress Syndrome: A Phase 2 Study of the Efficacy and Safety of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,2.0,,Replaced by a different protocol.,f,,,,,t,f,,,,,,,,,,,2024-10-16 11:41:12.098083,2024-10-16 11:41:12.098083,INDUSTRY,,,,,,,2022,0.0
NCT03339336,,2017-11-08,,,2021-04-30,2017-11-08,2017-11-13,ACTUAL,,,,,,,2021-04-30,2021-05-05,ACTUAL,2018-05-31,ACTUAL,2018-05-31,2021-04,2021-04-30,2021-04-12,ACTUAL,2021-04-12,2021-04-12,ACTUAL,2021-04-12,,INTERVENTIONAL,,,Efficacy and Safety Study of BIIB074 in Participants With Small Fiber Neuropathy,"A Phase 2 Placebo-Controlled, Double-Blind, Enriched Enrollment Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 (Vixotrigine) in Treating Pain Experienced by Subjects With Confirmed Small Fiber Neuropathy That is Idiopathic or Associated With Diabetes Mellitus",TERMINATED,,PHASE2,265.0,ACTUAL,Biogen,,3.0,,Sponsor decision to close study early; not due to safety concerns,f,,,,t,f,f,,,,,,,,,,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,INDUSTRY,,,,,,,2021,0.0
NCT03922620,,2019-04-17,2022-07-20,,2023-01-27,2019-04-17,2019-04-22,ACTUAL,2023-01-27,2023-02-23,ACTUAL,,,,2023-01-27,2023-02-23,ACTUAL,2020-01-23,ACTUAL,2020-01-23,2023-01,2023-01-31,2021-06-30,ACTUAL,2021-06-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,,Only 1 baseline participant included as only 1 total participant was enrolled in the study.,Liposomal Bupivacaine vs Peripheral Nerve Block,Liposomal Bupivacaine vs Peripheral Nerve Block,TERMINATED,,PHASE4,1.0,ACTUAL,Geisinger Clinic,,2.0,,Additional published information on the topic since starting the study,f,,,,f,t,f,,,t,,,,,,,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,OTHER,,,,,,,2021,0.0
NCT02706015,,2015-11-23,,,2019-04-09,2016-03-10,2016-03-11,ESTIMATED,,,,,,,2019-04-09,2019-04-10,ACTUAL,2020-10,ESTIMATED,2020-10-31,2019-04,2019-04-30,2021-07,ESTIMATED,2021-07-31,2021-05,ESTIMATED,2021-05-31,,INTERVENTIONAL,,,Cefaliv® Compared to Neosaldina® in the Treatment of Migraine Attacks,"National, Phase III, Multicenter, Randomized, Double-Blind, Parallel, Non-Inferiority Trial to Evaluate the Efficacy and Safety of Cefaliv® Compared to the Neosaldina® in the Treatment of Migraine Attacks",WITHDRAWN,,PHASE3,0.0,ACTUAL,Ache Laboratorios Farmaceuticos S.A.,,2.0,,Strategic reasons of the company,f,,,,f,f,f,,,,,,,,,,,2024-10-16 11:41:12.098083,2024-10-16 11:41:12.098083,INDUSTRY,,,,,,,2021,0.0
NCT02811497,,2016-06-21,,,2021-03-30,2016-06-21,2016-06-23,ESTIMATED,,,,,,,2021-03-30,2021-04-01,ACTUAL,2016-09,,2016-09-30,2021-03,2021-03-31,2020-08-04,ACTUAL,2020-08-04,2018-11-08,ACTUAL,2018-11-08,,INTERVENTIONAL,METADUR,,Study of Azacitidine and Durvalumab in Advanced Solid Tumors,"An Open-label, Phase II Basket Study of a hypoMEThylating Agent Oral Azacitidine and DURvalumab (MEDI4736) (Anti-PDL1) in Advanced Solid Tumors (METADUR)",COMPLETED,,PHASE2,28.0,ACTUAL,"University Health Network, Toronto",,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,OTHER,,,,,,,2020,0.0
NCT03905902,,2019-04-02,,,2021-12-06,2019-04-04,2019-04-08,ACTUAL,,,,,,,2021-12-06,2021-12-23,ACTUAL,2021-08,ESTIMATED,2021-08-31,2021-12,2021-12-31,2021-08-16,ACTUAL,2021-08-16,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,VITALIA,,"DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma","A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of DCVAC/OvCa Added to Standard of Care in Patients With Relapsed Platinum-sensitive Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma",WITHDRAWN,,PHASE3,0.0,ACTUAL,Sotio Biotech Inc.,,2.0,,Company decision,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,INDUSTRY,,,,,,,2021,0.0
NCT05712278,,2023-01-26,,,2024-04-10,2023-02-02,2023-02-03,ACTUAL,,,,,,,2024-04-10,2024-04-12,ACTUAL,2023-06-16,ACTUAL,2023-06-16,2024-04,2024-04-30,2024-03-12,ACTUAL,2024-03-12,2024-02-23,ACTUAL,2024-02-23,,INTERVENTIONAL,,,A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Relapsed/Refractory Acute Myeloid Leukemia,"A Phase I, Single-arm, Open Label, Dose Escalation, Multicenter Study of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)",TERMINATED,,PHASE1,7.0,ACTUAL,Sanofi,,1.0,,Sponsor's decision,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,INDUSTRY,,,,,,,2024,0.0
NCT02300194,,2014-11-20,,,2020-04-20,2014-11-20,2014-11-24,ESTIMATED,,,,,,,2020-04-20,2020-04-22,ACTUAL,2014-12,,2014-12-31,2020-04,2020-04-30,2020-04,ESTIMATED,2020-04-30,2020-04,ACTUAL,2020-04-30,,INTERVENTIONAL,,,"Randomized, Double-blind, Placebo, Controlled Cross Over Design Topical Morphine for Analgesia in Pediatric Procedures","Topical Morphine for Analgesia in Pediatric Procedures. Clinical Trial Randomized, Double-blind, Placebo.",WITHDRAWN,,PHASE4,0.0,ACTUAL,Hospital General de Niños Pedro de Elizalde,,2.0,,Withdrawn by investigators,f,,,,t,,,,,,,,,,,,,2024-10-16 11:41:12.098083,2024-10-16 11:41:12.098083,OTHER,,,,,,,2020,0.0
NCT03427125,,2018-01-19,2022-12-07,2020-08-11,2023-06-08,2018-02-02,2018-02-09,ACTUAL,2023-06-08,2023-06-29,ACTUAL,,2023-06-29,ACTUAL,2023-06-08,2023-06-29,ACTUAL,2018-01-08,ACTUAL,2018-01-08,2023-06,2023-06-30,2020-02-27,ACTUAL,2020-02-27,2019-11-15,ACTUAL,2019-11-15,,INTERVENTIONAL,,"Placebo was only used in the randomized withdrawal period (RWP). In the RWP, patients from the tenapanor (TEN) group were randomized 1:1 to either remain on TEN or receive a matching placebo. The patients on Sevelamer were not included in this part of the protocol.",A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis,"A 26-Wk, Phase 3, Open Label (OL) Study With a 12-Wk, Placebo-Controlled, Randomized Withdrawal Period and an OL Safety Extension to Evaluate the Safety and Efficacy of Tenapanor to Treat Hyperphosphatemia in CKD Patients on Dialysis",COMPLETED,,PHASE3,1559.0,ACTUAL,Ardelyx,,3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,INDUSTRY,,,,,,,2020,1.0
NCT04667104,,2020-12-09,2024-04-17,2023-05-15,2024-06-06,2020-12-09,2020-12-14,ACTUAL,2024-06-06,2024-07-03,ACTUAL,,2024-07-03,ACTUAL,2024-06-06,2024-07-03,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2024-06,2024-06-30,2023-04-17,ACTUAL,2023-04-17,2022-05-16,ACTUAL,2022-05-16,,INTERVENTIONAL,PENGUIN,,"A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection","A Phase 2, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Patients With Chronic Hepatitis B Virus Infection",COMPLETED,,PHASE2,48.0,ACTUAL,"Janssen Research & Development, LLC",,1.0,,,f,,,,f,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu",2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,INDUSTRY,,,,,,,2023,1.0
NCT03606980,,2018-06-29,2024-01-04,,2024-02-07,2018-07-23,2018-07-31,ACTUAL,2024-02-07,2024-03-06,ACTUAL,,,,2024-02-07,2024-03-06,ACTUAL,2018-11-05,ACTUAL,2018-11-05,2024-02,2024-02-29,2023-03-01,ACTUAL,2023-03-01,2021-12-22,ACTUAL,2021-12-22,,INTERVENTIONAL,,,Iontophoresis With Dexamethasone and Physical Therapy to Treat Apophysitis of the Knee in Pediatrics,"Iontophoresis With Dexamethasone in Combination With Physical Therapy for the Treatment of Pediatric Patients Diagnosed With Apophysitis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Trial",TERMINATED,,PHASE2,45.0,ACTUAL,"Children's Health System, Inc.","Our study was limited by limited enrollment, primarily as a result of the COVID-19 pandemic. Slow enrollment following the pandemic led to early closure of the study.",3.0,,Slow enrollment,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,OTHER,,,,,,,2023,0.0
NCT03998293,,2019-06-24,,,2022-12-13,2019-06-25,2019-06-26,ACTUAL,,,,,,,2022-12-13,2022-12-15,ACTUAL,2022-11,ESTIMATED,2022-11-30,2022-12,2022-12-31,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Direct Measurement of Proinsulin Clearance in Humans,Direct Measurement of Proinsulin Clearance in Humans,WITHDRAWN,,PHASE4,0.0,ACTUAL,Mayo Clinic,,1.0,,Newly available data suggests that measuring proinsulin clearance would not enhance predictive value of serum proinsulin,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,OTHER,,,,,,,2023,0.0
NCT01817751,,2013-03-20,2021-08-17,,2024-06-24,2013-03-20,2013-03-25,ESTIMATED,2021-10-27,2021-10-28,ACTUAL,,,,2024-06-24,2024-07-17,ACTUAL,2013-04-11,ACTUAL,2013-04-11,2024-06,2024-06-30,2023-05-12,ACTUAL,2023-05-12,2020-08-27,ACTUAL,2020-08-27,,INTERVENTIONAL,,,"Sorafenib, Valproic Acid, and Sildenafil in Treating Patients With Recurrent High-Grade Glioma","Phase 2 Study of Sorafenib, Valproic Acid, and Sildenafil in the Treatment of Recurrent High-Grade Glioma",COMPLETED,,PHASE2,47.0,ACTUAL,Virginia Commonwealth University,,1.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,OTHER,,,,,,,2023,1.0
NCT04243850,,2020-01-21,,,2021-10-05,2020-01-24,2020-01-28,ACTUAL,,,,,,,2021-10-05,2021-10-08,ACTUAL,2020-07-01,ESTIMATED,2020-07-01,2021-10,2021-10-31,2022-03-01,ESTIMATED,2022-03-01,2022-03-01,ESTIMATED,2022-03-01,,INTERVENTIONAL,REGROUP,,REGROUP: Renohemodynamic Effects empaGliflozin in vaRiOUs Populations,"A Single-center, Prospective, Placebo-controlled, Double-blind, Randomized, Cross-over Mechanistic Intervention Study to Investigate the Effect of Empagliflozin on Kidney Function in People With Either Preserved or Impaired Kidney Function With or Without Type 2 Diabetes",WITHDRAWN,,PHASE4,0.0,ACTUAL,"Amsterdam UMC, location VUmc",,2.0,,COVID,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,OTHER,,,,,,,2022,0.0
NCT04188639,,2019-12-04,,,2023-01-06,2019-12-05,2019-12-06,ACTUAL,,,,,,,2023-01-06,2023-01-09,ACTUAL,2021-03-23,ACTUAL,2021-03-23,2023-01,2023-01-31,2023-01-04,ACTUAL,2023-01-04,2023-01-04,ACTUAL,2023-01-04,,INTERVENTIONAL,,,Emicizumab in Acquired Hemophilia A,"Emicizumab in Patients With Acquired Hemophilia A: Multicenter, Single-arm, Open-label Clinical Trial",COMPLETED,,PHASE2,47.0,ACTUAL,GWT-TUD GmbH,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 11:41:12.098083,2024-10-16 11:41:12.098083,OTHER,,,,,,,2023,1.0
NCT03318939,,2017-10-10,,2024-04-01,2024-04-01,2017-10-20,2017-10-24,ACTUAL,,,,,2024-01-26,ACTUAL,2024-04-01,2024-04-03,ACTUAL,2017-10-13,ACTUAL,2017-10-13,2024-04,2024-04-30,2023-04-03,ACTUAL,2023-04-03,2023-04-03,ACTUAL,2023-04-03,,INTERVENTIONAL,,,Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation,"A Phase 2 Study of Poziotinib in Patients With Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic, With EGFR or HER2 Exon 20 Insertion Mutation (ZENITH20)",TERMINATED,,PHASE2,648.0,ACTUAL,"Spectrum Pharmaceuticals, Inc",,1.0,,Strategic business decision (unrelated to safety),f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,INDUSTRY,,,,,,,2023,0.0
NCT06297642,,2024-03-01,,,2024-08-04,2024-03-01,2024-03-07,ACTUAL,,,,,,,2024-08-04,2024-08-06,ACTUAL,2024-05-24,ACTUAL,2024-05-24,2024-01,2024-01-31,2024-07-31,ACTUAL,2024-07-31,2024-07-31,ACTUAL,2024-07-31,,INTERVENTIONAL,,,TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors.,A Phase Ib Clinical Trial of TQB2928 Injection Combined With Penpulimab in the Treatment of Patients With Advanced Malignant Tumors.,TERMINATED,,PHASE1,3.0,ACTUAL,"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",,1.0,,"Based on the current status of the same target research and the company's overall layout in the field of tumors, the early termination was determined after full communication with the principal investigator of the group leader unit.",f,,,,,f,f,,,,,,,,,,,2024-10-16 11:41:12.098083,2024-10-16 11:41:12.098083,INDUSTRY,,,,,,,2024,0.0
NCT05115019,,2021-11-09,,,2023-02-08,2021-11-09,2021-11-10,ACTUAL,,,,,,,2023-02-08,2023-02-10,ACTUAL,2021-12,ESTIMATED,2021-12-31,2023-02,2023-02-28,2022-04,ESTIMATED,2022-04-30,2022-02,ESTIMATED,2022-02-28,,INTERVENTIONAL,,,A Clinical Trial to Evaluate the Efficacy of RUTI® to Reduce the Severity of SARS-CoV-2 Infection (COVID-19),"A Phase II/III, Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of RUTI® to Reduce the Severity of SARS-CoV-2 Infection",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,PT. Innovative Pharma Solutions,,2.0,,Decrease of incidence and severity of COVID and availability of therapeutic alternatives,f,,,,,f,f,,,,,,,,,,,2024-10-15 15:18:40.354512,2024-10-15 15:18:40.354512,INDUSTRY,,,,,,,2022,0.0
NCT04766476,,2021-02-19,,,2022-06-08,2021-02-22,2021-02-23,ACTUAL,,,,,,,2022-06-08,2022-06-09,ACTUAL,2021-02-24,ACTUAL,2021-02-24,2022-06,2022-06-30,2021-08-12,ACTUAL,2021-08-12,2021-08-12,ACTUAL,2021-08-12,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease",TERMINATED,,PHASE1,9.0,ACTUAL,Bristol-Myers Squibb,,3.0,,Business objectives have changed,f,,,,f,t,f,,,,,,,,,,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,INDUSTRY,,,,,,,2021,0.0
NCT03066466,,2017-02-23,,,2021-04-23,2017-02-23,2017-02-28,ACTUAL,,,,,,,2021-04-23,2021-04-27,ACTUAL,2019-12-10,ESTIMATED,2019-12-10,2021-04,2021-04-30,2021-02-28,ESTIMATED,2021-02-28,2020-02-28,ESTIMATED,2020-02-28,,INTERVENTIONAL,,,Randomized Study: Standard of Care With or Without Atorvastatin for Prevention of GVHD for Matched Unrelated Donor BMT,Randomized Study of Atorvastatin Prophylaxis as a Supplement to Standard of Care Prophylaxis to Prevent Chronic Graft Versus Host Disease Allogeneic Stem Cell Transplantation From Matched Unrelated Donors,WITHDRAWN,,PHASE3,0.0,ACTUAL,Loyola University,,2.0,,No participants were enrolled,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 11:41:12.098083,2024-10-16 11:41:12.098083,OTHER,,,,,,,2021,0.0
NCT03387111,,2017-12-21,2024-04-03,,2024-07-23,2017-12-28,2017-12-29,ACTUAL,2024-07-23,2024-08-05,ACTUAL,,,,2024-07-23,2024-08-05,ACTUAL,2018-01-09,ACTUAL,2018-01-09,2020-08,2020-08-31,2021-01-11,ACTUAL,2021-01-11,2019-04-17,ACTUAL,2019-04-17,,INTERVENTIONAL,,,QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed,QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Molecularly Informed Integrated Immunotherapy Combining (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With SCC Who Have Progressed on or After Platinum-based Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Therapy,TERMINATED,,PHASE1/PHASE2,4.0,ACTUAL,"ImmunityBio, Inc.",,1.0,,Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention,f,,,,t,t,f,,,,,,,,,,,2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,INDUSTRY,,,,,,,2021,0.0
NCT03751436,,2018-11-20,,,2023-10-13,2018-11-20,2018-11-23,ACTUAL,,,,,,,2023-10-13,2023-10-16,ACTUAL,2019-08-02,ACTUAL,2019-08-02,2023-10,2023-10-31,2023-08-11,ACTUAL,2023-08-11,2022-07-18,ACTUAL,2022-07-18,,INTERVENTIONAL,,,Enzalutamide With Venetoclax in Treating Patients With Metastatic Castration Resistant Prostate Cancer,Phase Ib/II Study of Enzalutamide With Venetoclax (ABT-199) in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC),COMPLETED,,PHASE1,10.0,ACTUAL,Roswell Park Cancer Institute,,1.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,OTHER,,,,,,,2023,1.0
NCT04415658,,2020-05-27,2023-10-18,,2023-12-18,2020-05-29,2020-06-04,ACTUAL,2023-12-18,2024-01-10,ACTUAL,,,,2023-12-18,2024-01-10,ACTUAL,2020-12-01,ACTUAL,2020-12-01,2023-12,2023-12-31,2022-12-06,ACTUAL,2022-12-06,2022-11-06,ACTUAL,2022-11-06,,INTERVENTIONAL,,,Intravenous Thyroxine for Heart-Eligible Organ Donors,A Multicenter Randomized Placebo-Controlled Trial of Intravenous Thyroxine for Heart-Eligible Brain Dead Organ Donors,COMPLETED,,PHASE3,838.0,ACTUAL,Washington University School of Medicine,"Not blinded, open-label use of levothyroxine permitted in control group after 12 hours (only 50 donors in that group received open-label, plus three who crossed-over to levothyroxine immediately after randomization)",2.0,,,f,,,,t,t,f,,,f,,,,,,NO,Researchers within the study consortium only,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,OTHER,,,,,,,2022,1.0
NCT05384379,,2022-05-17,,,2023-05-30,2022-05-17,2022-05-20,ACTUAL,,,,,,,2023-05-30,2023-06-01,ACTUAL,2022-11-23,ACTUAL,2022-11-23,2023-05,2023-05-31,2023-03-03,ACTUAL,2023-03-03,2023-03-03,ACTUAL,2023-03-03,,INTERVENTIONAL,,,Efficacy and Safety Evaluation of BZ371B in ARDS Patients,"Clinical Study to Evaluate the Efficacy and Safety od BZ371B in Patients With Acute Respiratory Distress System (ARDS) in Mechanical Ventilation, Due to Respiratory Infections",TERMINATED,,EARLY_PHASE1,1.0,ACTUAL,Biozeus Biopharmaceutical S.A.,,1.0,,Suboptimal enrollment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,INDUSTRY,,,,,,,2023,0.0
NCT04144140,,2019-10-28,2023-07-25,,2023-07-25,2019-10-28,2019-10-30,ACTUAL,2023-07-25,2024-03-07,ACTUAL,,,,2023-07-25,2024-03-07,ACTUAL,2020-02-24,ACTUAL,2020-02-24,2023-03,2023-03-31,2022-07-26,ACTUAL,2022-07-26,2022-07-26,ACTUAL,2022-07-26,,INTERVENTIONAL,,"The full analysis set included all participants who received at least 1 dose of study drug. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.",Study of Intratumorally Administered Stimulator of Interferon Genes (STING) Agonist E7766 in Participants With Advanced Solid Tumors or Lymphomas - INSTAL-101,"An Open-Label, Multicenter Phase 1/1b Study of Intratumorally Administered STING Agonist E7766 in Subjects With Advanced Solid Tumors or Lymphomas - INSTAL-101",TERMINATED,,PHASE1,24.0,ACTUAL,Eisai Inc.,"The study was terminated earlier due to corporate strategic decision, which is unrelated to safety. In addition, there is no clinical activity data that informed the decision. Therefore, no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.",2.0,,"The study was terminated earlier due to a business decision; which was unrelated to safety. In addition, there was no clinical activity data that informed the decision.",f,,,,f,t,f,,,,,,,,,YES,Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,INDUSTRY,,,,,,,2022,0.0
NCT02860117,,2016-07-26,,,2021-05-20,2016-08-08,2016-08-09,ESTIMATED,,,,,,,2021-05-20,2021-05-25,ACTUAL,2018-01,ESTIMATED,2018-01-31,2021-05,2021-05-31,2020-05-01,ACTUAL,2020-05-01,2019-01-01,ACTUAL,2019-01-01,,INTERVENTIONAL,ccimb,,Ketamine Continuous Infusion on Opioid Consumption and Pain Management in Severe Burned Patients,"The Effectiveness of Ketamine Continuous Infusion on Opioid Consumption and Pain Management in Severe Burned Patients, a Randomized, Double-blind, Placebo-controlled Study",WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Sao Paulo General Hospital,,2.0,,change in hospital policy,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,OTHER,,,,,,,2020,0.0
NCT04599933,,2020-10-19,2023-11-12,2023-01-01,2024-04-02,2020-10-22,2020-10-23,ACTUAL,2023-11-12,2023-11-28,ACTUAL,2023-01-04,2023-01-09,ACTUAL,2024-04-02,2024-04-04,ACTUAL,2020-10-18,ACTUAL,2020-10-18,2020-10,2020-10-31,2022-02-19,ACTUAL,2022-02-19,2022-02-11,ACTUAL,2022-02-11,,INTERVENTIONAL,NEAR-1,The subject demographics and characteristics presented are for the Full Analysis Set (FAS).,An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1),"A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (the NEAR-1 Study: Near Eye-vision Acuity Restoration)",COMPLETED,,PHASE3,309.0,ACTUAL,Orasis Pharmaceuticals Ltd.,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,INDUSTRY,,,,,,,2022,1.0
NCT04250350,,2020-01-30,2022-12-15,,2023-01-30,2020-01-30,2020-01-31,ACTUAL,2023-01-30,2023-02-24,ACTUAL,,,,2023-01-30,2023-02-24,ACTUAL,2020-02-11,ACTUAL,2020-02-11,2023-01,2023-01-31,2022-06-22,ACTUAL,2022-06-22,2022-04-20,ACTUAL,2022-04-20,,INTERVENTIONAL,ADore,All enrolled or randomized participants who received at least one dose of study drug.,Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis,"An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis",COMPLETED,,PHASE3,206.0,ACTUAL,Eli Lilly and Company,,1.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,INDUSTRY,,,,,,,2022,1.0
NCT04752020,,2021-02-02,,,2024-03-11,2021-02-08,2021-02-12,ACTUAL,,,,,,,2024-03-11,2024-03-13,ACTUAL,2021-03-28,ACTUAL,2021-03-28,2024-03,2024-03-31,2023-12-30,ACTUAL,2023-12-30,2023-06-28,ACTUAL,2023-06-28,,INTERVENTIONAL,,,Netarsudil Use After Descemtorhexis Without Endothelial Keratoplasty,Prospective Assessment of Whether Adjuvant Netarsurdil Use Improves Post-Operative Outcomes in Patients Undergoing Descemetorhexis Without Endothelial Keratoplasty,COMPLETED,,EARLY_PHASE1,25.0,ACTUAL,Massachusetts Eye and Ear Infirmary,,1.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,OTHER,,,,,,,2023,1.0
NCT03531281,,2018-01-26,,,2018-12-05,2018-05-09,2018-05-21,ACTUAL,,,,,,,2018-12-05,2018-12-07,ACTUAL,2018-12-30,ESTIMATED,2018-12-30,2018-12,2018-12-31,2022-12-30,ESTIMATED,2022-12-30,2022-12-30,ESTIMATED,2022-12-30,,INTERVENTIONAL,,,Human Lysozyme Goat Milk in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant,A Randomized Pilot Study of Human Lysozyme Goat Milk in Recipients of Standard Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation,WITHDRAWN,,PHASE1,0.0,ACTUAL,City of Hope Medical Center,,2.0,,Administratively withdrawn,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,OTHER,,,,,,,2022,0.0
NCT04186871,,2019-11-28,2023-12-05,,2024-01-12,2019-12-02,2019-12-05,ACTUAL,2024-01-12,2024-01-16,ACTUAL,,,,2024-01-12,2024-01-16,ACTUAL,2020-01-07,ACTUAL,2020-01-07,2024-01,2024-01-31,2022-12-05,ACTUAL,2022-12-05,2022-12-05,ACTUAL,2022-12-05,,INTERVENTIONAL,,,"Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis","A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis",COMPLETED,,PHASE2,119.0,ACTUAL,Bristol-Myers Squibb,,6.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,INDUSTRY,,,,,,,2022,1.0
NCT02087865,,2014-03-07,2023-06-29,,2023-08-08,2014-03-13,2014-03-14,ESTIMATED,2023-08-08,2023-08-30,ACTUAL,,,,2023-08-08,2023-08-30,ACTUAL,2014-05,ACTUAL,2014-05-31,2023-08,2023-08-31,2021-12-20,ACTUAL,2021-12-20,2021-12-20,ACTUAL,2021-12-20,,INTERVENTIONAL,,The number reflects the participants who completed the study in the respective study groups.,Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease,Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease,COMPLETED,,PHASE4,89.0,ACTUAL,The Cleveland Clinic,,3.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,OTHER,,,,,,,2021,1.0
NCT03627767,,2018-05-29,2021-08-03,,2021-09-17,2018-08-08,2018-08-13,ACTUAL,2021-09-17,2021-09-20,ACTUAL,,,,2021-09-17,2021-09-20,ACTUAL,2018-06-11,ACTUAL,2018-06-11,2021-09,2021-09-30,2020-10-07,ACTUAL,2020-10-07,2020-09-02,ACTUAL,2020-09-02,,INTERVENTIONAL,,Full analysis set-randomized (FAS-RA) included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within Double-blind (DB) phase.,Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects,"A PHASE 3 RANDOMIZED WITHDRAWAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 IN SUBJECTS AGED 12 YEARS AND OVER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS WITH THE OPTION OF RESCUE TREATMENT IN FLARING SUBJECTS",COMPLETED,,PHASE3,1235.0,ACTUAL,Pfizer,"For outcome measure, Time to loss of response, the data collection window was extended for 45 days beyond the scheduled visit due to COVID 19.",3.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,INDUSTRY,,,,,,,2020,1.0
NCT05151471,,2021-11-28,,,2023-10-26,2021-11-28,2021-12-09,ACTUAL,,,,,,,2023-10-26,2023-10-30,ACTUAL,2022-01-11,ACTUAL,2022-01-11,2023-10,2023-10-31,2023-09-29,ACTUAL,2023-09-29,2023-09-29,ACTUAL,2023-09-29,,INTERVENTIONAL,,,Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS,"A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in Subjects With Amyotrophic Lateral Sclerosis (ALS)",TERMINATED,,PHASE3,202.0,ACTUAL,Mitsubishi Tanabe Pharma America Inc.,,2.0,,Futility Analysis of parent study MT-1186-A02 was met.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,INDUSTRY,,,,,,,2023,0.0
NCT03733067,,2018-11-06,,,2023-11-30,2018-11-06,2018-11-07,ACTUAL,,,,,,,2023-11-30,2023-12-04,ACTUAL,2023-11-30,ACTUAL,2023-11-30,2023-11,2023-11-30,2023-11-30,ACTUAL,2023-11-30,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,,,Safety and Efficacy of Abatacept for Treating Chronic Cytopenia in Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Haploinsufficiency,"Phase 1/2 Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of Abatacept for Treating Chronic Cytopenia in Cytotoxic T-lymphocyte Antigen 4 (CTLA4) Haploinsufficiency",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,No enrollment,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,NIH,,,,,,,2023,0.0
NCT04035850,,2019-06-17,,,2024-01-31,2019-07-26,2019-07-29,ACTUAL,,,,,,,2024-01-31,2024-02-02,ACTUAL,2019-08-01,ESTIMATED,2019-08-01,2024-01,2024-01-31,2021-08-01,ESTIMATED,2021-08-01,2021-08-01,ESTIMATED,2021-08-01,,INTERVENTIONAL,,,Vortioxetine for the Treatment of Hoarding Disorder,Vortioxetine for the Treatment of Hoarding Disorder- an Open Label Study,WITHDRAWN,,PHASE3,0.0,ACTUAL,St. Joseph's Healthcare Hamilton,,1.0,,COVID-19 pandemic,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,OTHER,,,,,,,2021,0.0
NCT05448391,,2022-07-01,,,2023-02-10,2022-07-06,2022-07-07,ACTUAL,,,,,,,2023-02-10,2023-02-13,ACTUAL,2022-09-13,ACTUAL,2022-09-13,2023-02,2023-02-28,2024-12-30,ESTIMATED,2024-12-30,2023-11-30,ESTIMATED,2023-11-30,,INTERVENTIONAL,,,A Study to Evaluate RIST4721 in Familial Mediterranean Fever (FMF),"An Open-label, Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of RIST4721 in Subjects With Familial Mediterranean Fever",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Aristea Therapeutics, Inc.",,1.0,,Due to safety findings in other ongoing Phase 2 trials.,f,,,,,t,f,,,t,,,,,,NO,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,INDUSTRY,,,,,,,2024,0.0
NCT04379336,,2020-05-04,,,2022-01-24,2020-05-06,2020-05-07,ACTUAL,,,,,,,2022-01-24,2022-01-25,ACTUAL,2020-05-04,ACTUAL,2020-05-04,2021-10,2021-10-31,2022-01-02,ACTUAL,2022-01-02,2022-01-02,ACTUAL,2022-01-02,,INTERVENTIONAL,,,BCG Vaccination for Healthcare Workers in COVID-19 Pandemic,"Reducing Morbidity and Mortality in Health Care Workers Exposed to SARS-CoV-2 by Enhancing Non-specific Immune Responses Through Bacillus Calmette-Guérin Vaccination, a Randomized Controlled Trial",COMPLETED,,PHASE3,1000.0,ACTUAL,TASK Applied Science,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,IPD will only be shared among researchers included in the protocol team at this stage.,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,OTHER,,,,,,,2022,0.0
NCT04841512,,2021-04-07,,,2022-03-02,2021-04-07,2021-04-12,ACTUAL,,,,,,,2022-03-02,2022-03-17,ACTUAL,2021-10,ESTIMATED,2021-10-31,2022-03,2022-03-31,2022-03-01,ACTUAL,2022-03-01,2022-03-01,ACTUAL,2022-03-01,,INTERVENTIONAL,,,Preliminary Safety and Efficacy of XT-150 in Facet Joint Osteoarthritis,"A Placebo-controlled, Double-blind Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Facet Joint Osteoarthritis Pain",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Xalud Therapeutics, Inc.",,3.0,,COVID - Lack of recruitment,f,,,,f,t,f,,,t,,,,,,NO,Not applicable. All patient records are de-identified,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,INDUSTRY,,,,,,,2022,0.0
NCT04785924,,2021-03-02,,,2024-08-29,2021-03-03,2021-03-08,ACTUAL,,,,,,,2024-08-29,2024-09-04,ACTUAL,2021-06-07,ACTUAL,2021-06-07,2022-06,2022-06-30,2023-01-12,ACTUAL,2023-01-12,2023-01-12,ACTUAL,2023-01-12,,INTERVENTIONAL,,,Imipenem/Cilastatin/Relebactam (IMI/REL) in Treatment of CRE Infections,A Study Comparing Prospective Use of Imipenem/Cilastatin/Relebactam (IMI/REL) to Retrospective Data Using Meropenem/ Vabobactam (MVB) and Ceftazidime/Avibactam (CZA) in Treatment of Klebsiella Producing Carbapenemase Enterobacteriaceae Infections,WITHDRAWN,,PHASE4,0.0,ACTUAL,Wake Forest University Health Sciences,,1.0,,Lack of enrollment,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,OTHER,,,,,,,2023,0.0
NCT02876835,,2016-08-19,2022-02-15,,2024-04-01,2016-08-19,2016-08-24,ESTIMATED,2022-04-12,2022-04-14,ACTUAL,,,,2024-04-01,2024-04-02,ACTUAL,2016-09-27,ACTUAL,2016-09-27,2024-03,2024-03-31,2021-04-19,ACTUAL,2021-04-19,2021-04-19,ACTUAL,2021-04-19,,INTERVENTIONAL,,All Randomized (Intent-to-treat \[ITT\]) Population comprised of all randomized participants. Participants were analyzed according to the treatment to which they were randomized.,Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND),"A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa",COMPLETED,,PHASE3,3872.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,t,t,f,,,,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://www.gsk.com/en-gb/innovation/trials/data-transparency,YES,Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,INDUSTRY,,,,,,,2021,1.0
NCT01576172,,2012-04-11,2020-10-21,,2020-10-21,2012-04-11,2012-04-12,ESTIMATED,2020-10-21,2020-11-12,ACTUAL,,,,2020-10-21,2020-11-12,ACTUAL,2012-03-30,ACTUAL,2012-03-30,2020-10,2020-10-31,2020-04-23,ACTUAL,2020-04-23,2019-10-23,ACTUAL,2019-10-23,,INTERVENTIONAL,,,Abiraterone Acetate and Prednisone With or Without Veliparib in Treating Patients With Metastatic Castration-Resistant Prostate Cancer,A Randomized Gene Fusion Stratified Phase 2 Trial of Abiraterone With or Without ABT-888 for Patients With Metastatic Castration-Resistant Prostate Cancer,COMPLETED,,PHASE2,159.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,NIH,,,,,,,2020,1.0
NCT02624388,,2015-10-27,2023-08-04,,2024-05-03,2015-12-03,2015-12-08,ESTIMATED,2024-05-03,2024-05-06,ACTUAL,,,,2024-05-03,2024-05-06,ACTUAL,2016-08,,2016-08-31,2024-05,2024-05-31,2021-09,ACTUAL,2021-09-30,2021-09,ACTUAL,2021-09-30,,INTERVENTIONAL,UVA-Gen001,,Study of Genistein in Pediatric Oncology Patients (UVA-Gen001),"A Randomized, Placebo-Controlled Pilot Study of Genistein Supplementation in Pediatric Cancer Patients Receiving Myelosuppressive Chemotherapy",TERMINATED,,PHASE2,4.0,ACTUAL,University of Virginia,,2.0,,Poor enrollment,f,,,,t,,,,,,,,,,,NO,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,OTHER,,,,,,,2021,0.0
NCT04793620,,2021-03-04,,,2022-10-28,2021-03-10,2021-03-11,ACTUAL,,,,,,,2022-10-28,2022-11-01,ACTUAL,2021-04-06,ACTUAL,2021-04-06,2022-10,2022-10-31,2022-02-14,ACTUAL,2022-02-14,2021-08-23,ACTUAL,2021-08-23,,INTERVENTIONAL,,,Pertussis Acellular Vaccine Adjuvanted With TQL1055,"A Phase 1, Randomized, Double Blind, Active-Controlled Dose-Escalation Study to Assess the Safety and Immunogenicity of Pertussis Acellular Vaccine Adjuvanted With TQL1055 (PAVA)",TERMINATED,,PHASE1,72.0,ACTUAL,"Adjuvance Technologies, Inc.",,2.0,,financial constraints,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,INDUSTRY,,,,,,,2022,0.0
NCT04498169,,2020-07-31,2022-08-10,,2022-08-31,2020-07-31,2020-08-04,ACTUAL,2022-08-10,2022-09-01,ACTUAL,,,,2022-08-31,2022-09-15,ACTUAL,2020-09-17,ACTUAL,2020-09-17,2022-08,2022-08-31,2021-08-11,ACTUAL,2021-08-11,2021-08-11,ACTUAL,2021-08-11,,INTERVENTIONAL,Fuchs,"40 participants were randomized; 20 each to the Netarsudil QD and the Netarsudil BID arms. 1 participant discontinued from each arm due to adverse events.~40 participants were included in both the mITT population for the primary endpoint analysis and the safety population for safety analysis.~6 participants were excluded from the per-protocol analysis due to protocol deviations (2 in the Netarsudil QD arm, 4 in the Netarsudil BID arm). There were no Covid-19 related protocol deviations.",A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy,"A Randomized, Open-Label, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Dosing Regimens of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy",COMPLETED,,PHASE2,40.0,ACTUAL,Aerie Pharmaceuticals,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,INDUSTRY,,,,,,,2021,1.0
NCT03508167,,2018-04-16,,,2019-07-03,2018-04-16,2018-04-25,ACTUAL,,,,,,,2019-07-03,2019-07-08,ACTUAL,2020-01,ESTIMATED,2020-01-31,2019-07,2019-07-31,2020-11,ESTIMATED,2020-11-30,2020-10,ESTIMATED,2020-10-31,,INTERVENTIONAL,Delfos,,"Security and Efficacy of Dorilax® (Fixed Association of Paracetamol 350 mg, Carisoprodol 150 mg and Caffeine 50 mg) Plus Thermal Band Compared to Placebo Plus Thermal Band in the Treatment of Acute Low Back Pain.","National, Phase III, Monocentric, Randomized, Double-blind, Controlled, Parallel, to Evaluate the Security and Efficacy of Dorilax® (Fixed Association of Paracetamol 350 mg, Carisoprodol 150 mg and Caffeine 50 mg) Plus Thermal Band Compared to Placebo Plus Thermal Band in the Treatment of Acute Low Back Pain.",WITHDRAWN,,PHASE3,0.0,ACTUAL,Ache Laboratorios Farmaceuticos S.A.,,2.0,,Study design will be reformulated,f,,,,f,f,f,,,,,,,,,,,2024-10-16 02:12:28.627396,2024-10-16 02:12:28.627396,INDUSTRY,,,,,,,2020,0.0
NCT05102162,,2021-10-29,2023-10-27,,2023-11-17,2021-10-29,2021-11-01,ACTUAL,2023-11-17,2023-12-12,ACTUAL,,,,2023-11-17,2023-12-12,ACTUAL,2021-12-17,ACTUAL,2021-12-17,2023-05,2023-05-31,2023-02-28,ACTUAL,2023-02-28,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,,"Each participant that was unenrolled from the study was assessed to determine if the data could be used in the final analysis. 17 participants completed the study and we unenrolled 18 participants. However, we were able to use the data from 1 participant in the final analysis",BL Infusion Trial:Beta-lactam Continuous Versus Intermittent Infusion and Associated Bacterial Resistance and Therapy Outcomes in Critically Ill Patients With Severe Pneumonia,Beta-lactam Continuous Versus Intermittent Infusion and Associated Bacterial Resistance and Therapy Outcomes in Critically Ill Patients With Severe Pneumonia,TERMINATED,,PHASE4,35.0,ACTUAL,University of Florida,"* Early termination leading to a small sample size and under-powered study.~* Repeat positive cultures may have been due to colonization and not active infection, especially in participants demonstrating clinical cure prior to repeat cultures.~* This study used MICs, which are generally accepted to have variability with repeat assessments, potentially up to 200% or more.",2.0,,Low recruitment.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,OTHER,,,,,,,2023,0.0
NCT04753606,,2021-02-09,2024-05-13,,2024-07-01,2021-02-09,2021-02-15,ACTUAL,2024-06-10,2024-06-11,ACTUAL,,,,2024-07-01,2024-07-12,ACTUAL,2021-02-18,ACTUAL,2021-02-18,2021-09,2021-09-30,2021-08-30,ACTUAL,2021-08-30,2021-05-24,ACTUAL,2021-05-24,,INTERVENTIONAL,ROSE,Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.,Randomized Study of Obicetrapib as an Adjunct to Statin Therapy,"A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Dose-Finding Study to Evaluate the Effect of Obicetrapib as an Adjunct to High-Intensity Statin Therapy",COMPLETED,,PHASE2,120.0,ACTUAL,NewAmsterdam Pharma,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,INDUSTRY,,,,,,,2021,1.0
NCT04732221,,2021-01-27,,,2024-07-18,2021-01-27,2021-02-01,ACTUAL,,,,,,,2024-07-18,2024-07-19,ACTUAL,2021-05-19,ACTUAL,2021-05-19,2024-07,2024-07-31,2024-07-02,ACTUAL,2024-07-02,2024-01-04,ACTUAL,2024-01-04,,INTERVENTIONAL,,,A Study of the Efficacy and Safety of MK-5475 in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007),"A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Arterial Hypertension",COMPLETED,,PHASE2/PHASE3,168.0,ACTUAL,Merck Sharp & Dohme LLC,,6.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,INDUSTRY,,,,,,,2024,1.0
NCT05014360,,2021-08-13,,,2023-06-01,2021-08-13,2021-08-20,ACTUAL,,,,,,,2023-06-01,2023-06-02,ACTUAL,2021-11-10,ACTUAL,2021-11-10,2023-06,2023-06-30,2023-02-15,ACTUAL,2023-02-15,2023-02-15,ACTUAL,2023-02-15,,INTERVENTIONAL,,,A Study of JNJ-64251330 in Participants With Familial Adenomatous Polyposis,"A Phase 1b Study to Evaluate the Efficacy and Safety of JNJ-64251330, a Janus Kinase (JAK) Inhibitor, in Participants With Familial Adenomatous Polyposis",COMPLETED,,PHASE1,42.0,ACTUAL,"Janssen Research & Development, LLC",,1.0,,,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,INDUSTRY,,,,,,,2023,0.0
NCT03015519,,2016-12-14,,,2019-01-16,2017-01-06,2017-01-10,ESTIMATED,,,,,,,2019-01-16,2019-01-17,ACTUAL,2017-08-14,ESTIMATED,2017-08-14,2019-01,2019-01-31,2020-04-20,ESTIMATED,2020-04-20,2020-04-20,ESTIMATED,2020-04-20,,INTERVENTIONAL,,,"A Study to Evaluate Pharmacokinetics, Safety and Efficacy of Albiglutide in Pediatric Subjects With Type 2 Diabetes Mellitus","A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Albiglutide for the Treatment of Type 2 Diabetes Mellitus in Pediatric Patients",WITHDRAWN,,PHASE3,0.0,ACTUAL,GlaxoSmithKline,,6.0,,The study did not start recruiting as albiglutide would have been withdrawn from the market prior to study end.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,INDUSTRY,,,,,,,2020,0.0
NCT04738136,,2021-01-27,,,2021-08-16,2021-02-03,2021-02-04,ACTUAL,,,,,,,2021-08-16,2021-08-23,ACTUAL,2021-09-15,ESTIMATED,2021-09-15,2021-02,2021-02-28,2021-12-31,ESTIMATED,2021-12-31,2021-10-31,ESTIMATED,2021-10-31,,INTERVENTIONAL,,,"Safety, Tolerability and Efficacy Of S-1226 in Moderate Severity Covid-19 Bronchiolitis/Pneumonia","A Randomized, Open-Label, Controlled, Phase II Study to Evaluate the Safety, Tolerability and Efficacy Of S-1226 In Hospitalized Subjects With Moderate Severity Covid-19 Bronchiolitis/Pneumonia",SUSPENDED,,PHASE2,30.0,ESTIMATED,SolAeroMed Inc.,,2.0,,Sponsor Decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,INDUSTRY,,,,,,,2021,0.0
NCT04935801,,2021-06-09,,,2022-11-28,2021-06-15,2021-06-23,ACTUAL,,,,,,,2022-11-28,2022-12-05,ACTUAL,2021-08-02,ACTUAL,2021-08-02,2022-11,2022-11-30,2022-09-15,ACTUAL,2022-09-15,2022-03-11,ACTUAL,2022-03-11,,INTERVENTIONAL,,,A Phase-I Study of a Nanoparticle-based Peptide Vaccine Against Dengue Virus,"naNO-DENGUE: A Phase I Double-blind, Randomized, Vehicle-controlled, Dose-finding, Safety Study of a Synthetic Nanoparticle-based, T-Cell Priming Peptide Vaccine Against Dengue Virus in Healthy Adults in Switzerland",COMPLETED,,PHASE1,26.0,ACTUAL,Emergex Vaccines Holding Ltd.,,4.0,,,f,,,,t,f,f,,,,,,Within 12 months of study completion,Peer-reviewed publication,,YES,"The Investigators will be involved in writing and/or reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study.~Apart from obvious flaws to the conduct of the study, which may preclude data publication, safety and efficacy data will be published under the supervision and authorization of PI and Sponsor.~Publication will include as much individual level data as possible to ensure reproducibility of results without compromising participant privacy.",2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,INDUSTRY,,,,,,,2022,1.0
NCT04128891,,2019-08-21,,,2021-08-24,2019-10-15,2019-10-16,ACTUAL,,,,,,,2021-08-24,2021-08-30,ACTUAL,2020-02-01,ESTIMATED,2020-02-01,2021-08,2021-08-31,2024-02-01,ESTIMATED,2024-02-01,2020-02-01,ESTIMATED,2020-02-01,,INTERVENTIONAL,PRISTINE-HF,,Study of Sacubitril/ValsarTan on MyocardIal OxygenatioN and Fibrosis in Heart Failure With Preserved Ejection Fraction,PRospectIve Study of Sacubitril/ValsarTan on MyocardIal OxygenatioN and Fibrosis in PatiEnts With Heart Failure and Preserved Ejection Fraction,WITHDRAWN,,PHASE3,0.0,ACTUAL,Flinders University,,2.0,,Funding not approved,f,,,,,f,f,,,f,,,,,,,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,OTHER,,,,,,,2024,0.0
NCT04933916,,2021-06-14,,,2023-08-07,2021-06-14,2021-06-22,ACTUAL,,,,,,,2023-08-07,2023-08-09,ACTUAL,2021-06-10,ACTUAL,2021-06-10,2023-08,2023-08-31,2023-05-01,ACTUAL,2023-05-01,2023-04-01,ACTUAL,2023-04-01,,INTERVENTIONAL,,,Study of EMB-001 as a Potential Smoking Cessation Treatment,Efficacy and Safety of Combination EMB-001 as a Potential Smoking Cessation Treatment,TERMINATED,,PHASE1/PHASE2,16.0,ACTUAL,"Embera NeuroTherapeutics, Inc.",,1.0,,Business decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,INDUSTRY,,,,,,,2023,0.0
NCT03597009,,2018-06-01,2021-02-26,,2021-03-25,2018-07-13,2018-07-24,ACTUAL,2021-03-25,2021-04-20,ACTUAL,,,,2021-03-25,2021-04-20,ACTUAL,2019-03-06,ACTUAL,2019-03-06,2021-03,2021-03-31,2020-02-12,ACTUAL,2020-02-12,2020-02-07,ACTUAL,2020-02-07,,INTERVENTIONAL,,,A Study of Nivolumab and Intrapleural Talimogene Laherparepvec for Malignant Pleural Effusion,A Phase Ib/II Study of IV Nivolumab and Intrapleural Talimogene Laherparepvec for Patients With Malignant Pleural Effusion,TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,UNC Lineberger Comprehensive Cancer Center,Study terminated early due to slow accrual and withdrawal of funding so only one participant was enrolled.,1.0,,due to slow accrual and withdrawal of funding,f,,,,t,t,f,,,,,,,,,,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,OTHER,,,,,,,2020,0.0
NCT03594955,,2018-07-02,2022-01-28,,2022-05-03,2018-07-19,2018-07-20,ACTUAL,2022-03-16,2022-04-07,ACTUAL,,,,2022-05-03,2022-05-24,ACTUAL,2018-10-24,ACTUAL,2018-10-24,2022-05,2022-05-31,2021-02-06,ACTUAL,2021-02-06,2021-02-06,ACTUAL,2021-02-06,,INTERVENTIONAL,,Analysis was performed on safety population which included all registered participants who had given their informed consent and had received at least 1 dose of SAR440234.,"First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome","An Open-label, First-in-human, Dose Escalation Study of SAR440234 Administered as Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), or High Risk Myelodysplasia (HR-MDS)",TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,Sanofi,"Sponsor decided to prioritize development of other novel therapies with more innovative mechanisms of action for R/R AML and other cancers. Thus, decided to terminate the study and stopped enrollment in Dose Expansion Part.",1.0,,Sponsor decision,f,,,,f,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,INDUSTRY,,,,,,,2021,0.0
NCT03536390,,2018-05-04,,,2018-10-30,2018-05-14,2018-05-24,ACTUAL,,,,,,,2018-10-30,2018-11-01,ACTUAL,2018-09-19,ESTIMATED,2018-09-19,2018-10,2018-10-31,2021-04-22,ESTIMATED,2021-04-22,2021-04-22,ESTIMATED,2021-04-22,,INTERVENTIONAL,,,A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD,"A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)",WITHDRAWN,,PHASE4,0.0,ACTUAL,Pfizer,,2.0,,The study was cancelled prior to the enrollment of any participants.,f,,,,t,t,f,,,,,,,,,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests,2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,INDUSTRY,,,,,,,2021,0.0
NCT05463393,,2022-07-15,,,2024-01-17,2022-07-15,2022-07-19,ACTUAL,,,,,,,2024-01-17,2024-01-18,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2024-01,2024-01-31,2024-12-31,ESTIMATED,2024-12-31,2022-01-30,ACTUAL,2022-01-30,,INTERVENTIONAL,,,Xanthohumol as an Adjuvant Therapy in Critically Ill COVID-19 Patients,Humulus Lupus Extract Rich in Xanthohumol Improves Clinical Course in Critically Ill COVID-19 Patients,SUSPENDED,,EARLY_PHASE1,50.0,ESTIMATED,Medical University of Lublin,,2.0,,We are waiting for the additional founds.,f,,,,,f,f,,,,,,,,,,,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,OTHER,,,,,,,2024,0.0
NCT04260360,,2020-02-05,,,2020-07-31,2020-02-05,2020-02-07,ACTUAL,,,,,,,2020-07-31,2020-08-04,ACTUAL,2020-04,ESTIMATED,2020-04-30,2020-07,2020-07-31,2022-10,ESTIMATED,2022-10-31,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma,Phase 1 Trial Evaluating the Safety and Tolerability of NanoDoce® Intratumoral Injection in Subjects With Localized Renal Cell Carcinoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,"NanOlogy, LLC",,1.0,,Not initiated,t,,,,f,t,f,,,,,,,,,NO,,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,INDUSTRY,,NCT04060628,AVAILABLE,,,,2022,0.0
NCT04254107,,2020-01-31,,,2024-01-17,2020-01-31,2020-02-05,ACTUAL,,,,,,,2024-01-17,2024-01-19,ACTUAL,2020-05-29,ACTUAL,2020-05-29,2024-01,2024-01-31,2023-12-01,ACTUAL,2023-12-01,2023-12-01,ACTUAL,2023-12-01,,INTERVENTIONAL,,,A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer,A Phase 1 Study of SEA-TGT (SGN-TGT) in Subjects With Advanced Malignancies,TERMINATED,,PHASE1,132.0,ACTUAL,Seagen Inc.,,3.0,,Study closed due to portfolio prioritization,f,,,,f,t,f,,,,,,,,,,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,INDUSTRY,,,,,,,2023,0.0
NCT03794583,,2019-01-02,2023-11-27,,2023-11-27,2019-01-03,2019-01-07,ACTUAL,2023-11-27,2023-12-18,ACTUAL,,,,2023-11-27,2023-12-18,ACTUAL,2018-12-21,ACTUAL,2018-12-21,2023-11,2023-11-30,2022-11-29,ACTUAL,2022-11-29,2022-11-29,ACTUAL,2022-11-29,,INTERVENTIONAL,PERFECT OLE,Safety population included all participants who received at least 1 dose of inhaled treprostinil.,Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD),An Open-Label Extension Study of Inhaled Treprostinil in Patients With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD),TERMINATED,,PHASE3,41.0,ACTUAL,United Therapeutics,"Per sponsor decision, the study was terminated early.",1.0,,Sponsor's decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,INDUSTRY,,,,,,,2022,0.0
NCT04450654,,2020-06-24,,,2022-10-19,2020-06-24,2020-06-29,ACTUAL,,,,,,,2022-10-19,2022-10-24,ACTUAL,2022-05,ESTIMATED,2022-05-31,2022-10,2022-10-31,2022-07-25,ACTUAL,2022-07-25,2022-07-25,ACTUAL,2022-07-25,,INTERVENTIONAL,,,Monotherapy IVIG Gamunex-C for HMG-CoA Reductase Auto-Antibody Positive Necrotizing Myopathy Treatment (The MIGHT Trial),Monotherapy IVIG Gamunex-C for HMG-CoA Reductase Auto-Antibody Positive Necrotizing Myopathy Treatment (The MIGHT Trial),WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Washington,,2.0,,No Participants Enrolled,f,,,,t,t,f,,,,,,,,,,,2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,OTHER,,,,,,,2022,0.0
NCT01192568,,2010-08-30,2024-08-12,,2024-08-12,2010-08-31,2010-09-01,ESTIMATED,2024-08-12,2024-09-04,ACTUAL,,,,2024-08-12,2024-09-04,ACTUAL,2011-05-17,ACTUAL,2011-05-17,2024-08,2024-08-31,2023-10-24,ACTUAL,2023-10-24,2023-08-29,ACTUAL,2023-08-29,,INTERVENTIONAL,,,Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder,"A Two-part, Multicenter, Dose-titration Study Evaluating the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Oxybutynin Chloride 10% Gel for the Treatment of Detrusor Overactivity Associated With a Neurological Condition in Pediatric Patients",COMPLETED,,PHASE4,52.0,ACTUAL,AbbVie,AbbVie has decided to discontinue further subject enrollment in the OG09002 (Oxybutynin) study. This decision is not based on a safety or an efficacy signal; rather this decision was made because of a change in AbbVie's development.,3.0,,,f,,,,f,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,INDUSTRY,,,,,,,2023,1.0
NCT03300921,,2017-09-29,,,2022-03-29,2017-09-29,2017-10-04,ACTUAL,,,,,,,2022-03-29,2022-03-31,ACTUAL,2017-09-28,ACTUAL,2017-09-28,2022-03,2022-03-31,2022-03-23,ACTUAL,2022-03-23,2020-08-30,ACTUAL,2020-08-30,,INTERVENTIONAL,,,A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer,A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer,TERMINATED,,PHASE1,3.0,ACTUAL,Abramson Cancer Center at Penn Medicine,,2.0,,Newer research suggested that paricalcitol may be harmful to a subset of pancreatic cancer patients and it is not feasible to subtype patients in the short time frame before surgery,f,,,,t,t,f,,,,,,,,,,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,OTHER,,,,,,,2022,0.0
NCT05242042,,2022-02-11,,,2023-09-20,2022-02-15,2022-02-16,ACTUAL,,,,,,,2023-09-20,2023-09-22,ACTUAL,2022-01-28,ACTUAL,2022-01-28,2023-09,2023-09-30,2023-03-23,ACTUAL,2023-03-23,2023-03-23,ACTUAL,2023-03-23,,INTERVENTIONAL,,,JT001 (VV116) for the Early Treatment of COVID-19,"A Multicenter, Double-blind, Randomized, Placebo-Controlled, Phase II/III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of JT001 (VV116) for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Participants With Mild to Moderate COVID-19.",TERMINATED,,PHASE2/PHASE3,381.0,ACTUAL,"Shanghai JunTop Biosciences Co., LTD",,2.0,,"Based on the current number of COVID-19 cases and the approval of COVID-19 treatment drugs , the research team is facing great challenges, and it is decided to terminate this study",f,,,,t,f,f,,,,,,,,,UNDECIDED,Undecided,2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,INDUSTRY,,,,,,,2023,0.0
NCT06145399,,2023-11-16,,,2024-04-30,2023-11-17,2023-11-24,ACTUAL,,,,,,,2024-04-30,2024-05-01,ACTUAL,2023-10-24,ACTUAL,2023-10-24,2024-04,2024-04-30,2024-04-29,ACTUAL,2024-04-29,2024-04-29,ACTUAL,2024-04-29,,INTERVENTIONAL,,,A Study of 1 8F-FDHT PET/MRIScans in Women With Breast Cancer,[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging In Patients Advanced Breast Cancer,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,No accruals,,,,,,t,f,,,,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,OTHER,,,,,,,2024,0.0
NCT02575404,,2015-10-09,,,2023-06-02,2015-10-09,2015-10-14,ESTIMATED,,,,,,,2023-06-02,2023-06-05,ACTUAL,2016-05-16,ACTUAL,2016-05-16,2023-05,2023-05-31,2022-10-10,ACTUAL,2022-10-10,2021-01-12,ACTUAL,2021-01-12,,INTERVENTIONAL,,,"GR-MD-02 Plus Pembrolizumab in Melanoma, Non-small Cell Lung Cancer, and Squamous Cell Head and Neck Cancer Patients","Phase IB Study of a Galectin Inhibitor (GR-MD-02) and Pembrolizumab in Patients With Metastatic Melanoma, Non-Small Cell Lung Cancer, and Head and Neck Squamous Cell Carcinoma.",COMPLETED,,PHASE1,36.0,ACTUAL,Providence Health & Services,,4.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,OTHER,,,,,,,2022,1.0
NCT04535518,,2020-08-27,,,2021-03-10,2020-08-28,2020-09-02,ACTUAL,,,,,,,2021-03-10,2021-03-12,ACTUAL,2020-10,ESTIMATED,2020-10-31,2021-03,2021-03-31,2022-09,ESTIMATED,2022-09-30,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,Efficacy of Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease,"Efficacy of Primary Treatment With Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease: a Multicenter, Open-label, Blinded-end Randomized Controlled Study.",WITHDRAWN,,PHASE3,0.0,ACTUAL,Children's Hospital of Fudan University,,2.0,,lack of funding,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,OTHER,,,,,,,2022,0.0
NCT03321513,,2017-10-23,2023-01-11,,2024-04-24,2017-10-23,2017-10-25,ACTUAL,2024-04-24,2024-04-25,ACTUAL,,,,2024-04-24,2024-04-25,ACTUAL,2017-12-07,ACTUAL,2017-12-07,2024-04,2024-04-30,2021-12-22,ACTUAL,2021-12-22,2021-12-22,ACTUAL,2021-12-22,,INTERVENTIONAL,DRCR AC,Units in Eyes,DRCR.Net Aflibercept vs. Bevacizumab + Deferred Aflibercept for the Treatment of CI-DME,Randomized Trial of Intravitreous Aflibercept Versus Intravitreous Bevacizumab + Deferred Aflibercept for Treatment of Central-Involved Diabetic Macular Edema,COMPLETED,,PHASE3,270.0,ACTUAL,Jaeb Center for Health Research,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 15:18:40.354512,2024-10-15 15:18:40.354512,OTHER,,,,,Eyes,,2021,0.0
NCT05678257,,2022-12-22,,,2024-08-29,2023-01-09,2023-01-10,ACTUAL,,,,,,,2024-08-29,2024-09-03,ACTUAL,2023-04-18,ACTUAL,2023-04-18,2024-08,2024-08-31,2024-08-29,ACTUAL,2024-08-29,2024-08-29,ACTUAL,2024-08-29,,INTERVENTIONAL,,,A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer,"A Randomised, Open-label, Phase II, Dose/Schedule Optimisation Study of NUC-3373/Leucovorin/Irinotecan Plus Bevacizumab (NUFIRI-bev) Versus 5-FU/Leucovorin/Irinotecan Plus Bevacizumab (FOLFIRI-bev) for the Treatment of Patients With Previously Treated Unresectable Metastatic Colorectal Cancer",TERMINATED,,PHASE2,182.0,ACTUAL,NuCana plc,,3.0,,"A pre-planned initial analysis concluded that the study was unlikely to achieve its primary objective of demonstrating superior progression-free survival. Based on the Steering Committee's recommendation, the Sponsor has closed the study.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,OTHER,,,,,,,2024,0.0
NCT00112931,,2005-06-02,,,2024-05-07,2005-06-02,2005-06-03,ESTIMATED,,,,,,,2024-05-07,2024-05-09,ACTUAL,2004-09,,2004-09-30,2024-05,2024-05-31,2023-09-14,ACTUAL,2023-09-14,2014-03,ACTUAL,2014-03-31,,INTERVENTIONAL,,,"Rituximab in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma","An Intergroup Randomised Trial of Rituximab Versus a Watch and Wait Strategy in Patients With Advanced Stage, Asymptomatic, Non-Bulky Follicular Lymphoma",COMPLETED,,PHASE3,462.0,ACTUAL,"University College, London",,2.0,,,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,OTHER,,,,,,,2023,1.0
NCT03654313,,2018-08-29,,,2020-08-21,2018-08-29,2018-08-31,ACTUAL,,,,,,,2020-08-21,2020-08-24,ACTUAL,2018-09-28,ACTUAL,2018-09-28,2020-08,2020-08-31,2020-07-21,ACTUAL,2020-07-21,2020-07-21,ACTUAL,2020-07-21,,INTERVENTIONAL,,,Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus,"A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus.",COMPLETED,,PHASE1,88.0,ACTUAL,MedImmune LLC,,11.0,,,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,INDUSTRY,,,,,,,2020,1.0
NCT03768505,,2018-12-04,2023-12-05,,2024-01-08,2018-12-06,2018-12-07,ACTUAL,2024-01-08,2024-02-01,ACTUAL,,,,2024-01-08,2024-02-01,ACTUAL,2019-06-25,ACTUAL,2019-06-25,2022-12,2022-12-31,2023-03-24,ACTUAL,2023-03-24,2023-03-24,ACTUAL,2023-03-24,,INTERVENTIONAL,,,Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL),"A Multicenter, Open Label Single-Arm, Phase 2 Study of Zandelisib (ME-401) in Subjects With Follicular Lymphoma and Marginal Zone Lymphoma After Failure of Two or More Prior Systemic Therapies (The TIDAL Study)",TERMINATED,,PHASE2,169.0,ACTUAL,"MEI Pharma, Inc.",The study was closed prematurely for business reasons.,1.0,,discontinuation of zandelisib program,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,INDUSTRY,,,,,,,2023,0.0
NCT02243709,,2014-09-12,2023-01-18,,2023-05-04,2014-09-17,2014-09-18,ESTIMATED,2023-05-04,2023-06-01,ACTUAL,,,,2023-05-04,2023-06-01,ACTUAL,2014-09,ACTUAL,2014-09-30,2023-05,2023-05-31,2021-12-21,ACTUAL,2021-12-21,2021-12-21,ACTUAL,2021-12-21,,INTERVENTIONAL,,,Mifepristone for the Prevention of Relapses of Alcohol Drinking,A Pilot Study on the Safety and Efficacy of Mifepristone for the Prevention of Relapses of Alcohol Drinking,COMPLETED,,PHASE1/PHASE2,32.0,ACTUAL,Brown University,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,OTHER,,,,,,,2021,1.0
NCT04784897,,2021-03-03,2022-07-27,,2022-08-22,2021-03-03,2021-03-05,ACTUAL,2022-08-22,2022-09-16,ACTUAL,,,,2022-08-22,2022-09-16,ACTUAL,2021-02-22,ACTUAL,2021-02-22,2022-08,2022-08-31,2021-07-30,ACTUAL,2021-07-30,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,,"Study participants were randomized to active or placebo, and dependent upon if prior to or after the scheduled interim safety analysis, were randomized to 3 days or 5 days of study treatment.~Subjects randomized to placebo are pooled for the analyses since duration of placebo should not impact efficacy or safety outcomes. As the different treatment durations for Brilacidin have potential to impact efficacy and/or safety outcomes, 3-dose and 5-dose active arms were analyzed separately.",A Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19,"A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19",COMPLETED,,PHASE2,120.0,ACTUAL,"Innovation Pharmaceuticals, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,INDUSTRY,,,,,,,2021,1.0
NCT04511975,,2020-08-05,,,2020-12-17,2020-08-11,2020-08-13,ACTUAL,,,,,,,2020-12-17,2020-12-21,ACTUAL,2020-08-24,ACTUAL,2020-08-24,2020-12,2020-12-31,2022-04-04,ESTIMATED,2022-04-04,2021-10-31,ESTIMATED,2021-10-31,,INTERVENTIONAL,,,A Study Evaluating the Safety and Efficacy of IBI188 in Combination With AZA in Subjects With Newly Diagnosed MDS,A Phase 1b Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (MDS),SUSPENDED,,PHASE1,32.0,ESTIMATED,Innovent Biologics (Suzhou) Co. Ltd.,,1.0,,pause for further assessment and study adjustment,,,,,f,t,f,,,,,,,,,,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,INDUSTRY,,,,,,,2022,0.0
NCT04106843,,2019-09-25,,,2020-09-03,2019-09-25,2019-09-27,ACTUAL,,,,,,,2020-09-03,2020-09-07,ACTUAL,2019-06-13,ESTIMATED,2019-06-13,2020-09,2020-09-30,2020-09-03,ACTUAL,2020-09-03,2020-09-03,ACTUAL,2020-09-03,,INTERVENTIONAL,,,"Radioactive Drug (177Lu-DOTATATE) for the Treatment of Locally Advanced, Metastatic, or Unresectable Rare Endocrine Cancers","A Phase II Study to Evaluate the Effects of 177Lu-DOTATATE in Patients With Unresectable and Progressive Rare Metastatic Endocrine Carcinomas: Medullary Thyroid Cancer, Parathyroid Carcinoma, Pituitary Carcinoma, and Malignant Pheochromocytoma/Paraganglioma",WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,No Participants Registered,f,,,,f,t,f,,,,,,,,,,,2024-10-15 15:18:40.354512,2024-10-15 15:18:40.354512,OTHER,,,,,,,2020,0.0
NCT02485990,,2015-06-26,,,2021-04-09,2015-06-29,2015-06-30,ESTIMATED,,,,,,,2021-04-09,2021-04-12,ACTUAL,2016-01-08,ACTUAL,2016-01-08,2021-04,2021-04-30,2020-03-05,ACTUAL,2020-03-05,2020-03-05,ACTUAL,2020-03-05,,INTERVENTIONAL,,,"Study of Tremelimumab Alone or Combined With Olaparib for Patients With Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma)","An Open Label Dose Escalation/Expansion Study of Tremelimumab Alone or Combined With Olaparib for Recurrent or Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma)",TERMINATED,,PHASE1,24.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,3.0,,Withdrawal of sponsor support,f,,,,t,,,,,,,,,,,,,2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,OTHER,,,,,,,2020,0.0
NCT03267888,,2017-08-29,2024-07-09,,2024-08-13,2017-08-29,2017-08-30,ACTUAL,2024-08-13,2024-09-04,ACTUAL,,,,2024-08-13,2024-09-04,ACTUAL,2018-05-29,ACTUAL,2018-05-29,2024-08,2024-08-31,2022-09-02,ACTUAL,2022-09-02,2022-09-02,ACTUAL,2022-09-02,,INTERVENTIONAL,,,Pembrolizumab and Radiation Therapy in Patients With Relapsed or Refractory Multiple Myeloma,"Pilot Study of Pembrolizumab and Single-Fraction, Low-Dose, Radiation Therapy in Patients With Relapsed or Refractory Multiple Myeloma",COMPLETED,,PHASE1/PHASE2,25.0,ACTUAL,Emory University,,1.0,,,,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,OTHER,,,,,,,2022,1.0
NCT04250337,,2020-01-30,2022-03-14,,2022-05-05,2020-01-30,2020-01-31,ACTUAL,2022-04-04,2022-05-02,ACTUAL,,,,2022-05-05,2022-05-09,ACTUAL,2020-02-03,ACTUAL,2020-02-03,2022-05,2022-05-31,2021-09-16,ACTUAL,2021-09-16,2021-08-11,ACTUAL,2021-08-11,,INTERVENTIONAL,ADhere,"All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.",Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.,"A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy and Safety of Lebrikizumab When Used In Combination With Topical Corticosteroid Treatment In Patients With Moderate-To-Severe Atopic Dermatitis",COMPLETED,,PHASE3,228.0,ACTUAL,Eli Lilly and Company,"One investigational site with seventeen participants was excluded from analysis due to GCP issues.~Because of an error in the electronic data collection tool, the actual maximum score for each of the SCORAD symptoms was 9 instead of 10, resulting in a total maximum SCORAD score of 101 instead of 103. During the study, discussions with the SCORAD copyright owner resulted in a decision not to adjust the scale used or notify investigators as the altered scale was not expected to bias the results.",2.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 15:18:40.354512,2024-10-15 15:18:40.354512,INDUSTRY,,,,,,,2021,1.0
NCT03634683,,2018-07-20,,,2022-06-27,2018-08-15,2018-08-16,ACTUAL,,,,,,,2022-06-27,2022-06-30,ACTUAL,2018-08,ESTIMATED,2018-08-31,2022-06,2022-06-30,2022-08,ESTIMATED,2022-08-31,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,,,A Study of LioCyx in Patient With Recurrent HBV-related HCC Post Liver Transplantation,"A Phase I/II, Open Label, Single Arm, Multicenter Study of LioCyx in Subjects With Recurrent Hepatitis B Virus-Related Hepatocellular Carcinoma Post Liver Transplantation",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Lion TCR Pte. Ltd.,,1.0,,Major changes in manufacturing process and investigational product,f,,,,,f,f,,,f,,,,,,,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,INDUSTRY,,,,,,,2022,0.0
NCT03485911,,2018-03-15,2020-11-17,,2023-05-31,2018-03-30,2018-04-03,ACTUAL,2021-02-10,2021-03-02,ACTUAL,,,,2023-05-31,2023-06-26,ACTUAL,2018-02-06,ACTUAL,2018-02-06,2023-05,2023-05-31,2022-04-06,ACTUAL,2022-04-06,2019-04-10,ACTUAL,2019-04-10,,INTERVENTIONAL,APeX-2,Intent to treat population,Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE,"A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX7353 as an Oral Treatment for the Prevention of Attacks in Subjects With Hereditary Angioedema",COMPLETED,,PHASE3,121.0,ACTUAL,BioCryst Pharmaceuticals,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 15:18:40.354512,2024-10-15 15:18:40.354512,INDUSTRY,,,,,,,2022,1.0
NCT03696537,,2018-10-02,,,2022-02-22,2018-10-03,2018-10-04,ACTUAL,,,,,,,2022-02-22,2022-03-09,ACTUAL,2018-08-29,ACTUAL,2018-08-29,2022-02,2022-02-28,2021-04-13,ACTUAL,2021-04-13,2020-07-08,ACTUAL,2020-07-08,,INTERVENTIONAL,,,IMRT-TMI With Fludarabine as Myeloablative Conditioning for Allogeneic HSCT,A Dose Escalation Study of Intensity Modulated Total Marrow Irradiation (IMRT-TMI) With Fludarabine as a Myeloablative Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Relapsed and Refractory Hematologic Malignancies,TERMINATED,,PHASE1,6.0,ACTUAL,Indiana University,,1.0,,Extreme toxicity,f,,,,t,t,f,,,,,,,,,,,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,OTHER,,,,,,,2021,0.0
NCT03509870,,2018-04-11,,,2020-08-17,2018-04-25,2018-04-26,ACTUAL,,,,,,,2020-08-17,2020-08-19,ACTUAL,2018-06-01,ACTUAL,2018-06-01,2020-08,2020-08-31,2020-04-01,ACTUAL,2020-04-01,2020-04-01,ACTUAL,2020-04-01,,INTERVENTIONAL,REDDSTAR,,Bone Marrow Derived Allogeneic Mesenchymal Stromal Cells to Non-healing Diabetic Foot Wounds,Uncontrolled Non-randomised Single Dose Study of Topically Applied Bone Marrow Derived Allogeneic Mesenchymal Stromal Cells (REDDSTAR (ORBCEL-M)) in Patients With Non-healing Neuroischaemic Diabetic Foot Wounds',TERMINATED,,PHASE1,2.0,ACTUAL,Steno Diabetes Center Copenhagen,,1.0,,study stopped because of lack of recruitment,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-16 23:19:02.870402,2024-10-16 23:19:02.870402,OTHER,,,,,,,2020,0.0
NCT04186637,,2019-11-27,,,2023-06-02,2019-12-02,2019-12-05,ACTUAL,,,,,,,2023-06-02,2023-06-05,ACTUAL,2020-06-02,ACTUAL,2020-06-02,2023-06,2023-06-30,2023-02-28,ACTUAL,2023-02-28,2022-11-09,ACTUAL,2022-11-09,,INTERVENTIONAL,NEON-1,,An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies,An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies (NEON-1),TERMINATED,,PHASE1,62.0,ACTUAL,"Alpine Immune Sciences, Inc.",,1.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,INDUSTRY,,,,,,,2023,0.0
NCT03602976,,2018-07-19,2023-01-20,,2023-06-05,2018-07-19,2018-07-27,ACTUAL,2023-06-05,2023-06-07,ACTUAL,,,,2023-06-05,2023-06-07,ACTUAL,2018-08-20,ACTUAL,2018-08-20,2023-06,2023-06-30,2022-01-12,ACTUAL,2022-01-12,2022-01-12,ACTUAL,2022-01-12,,INTERVENTIONAL,,Number of subjects that completed observation period of 6 months,Ursodeoxycholic Acid (UDCA) for Hepatic Sarcoidosis,"A Single-center, Open Label, Cross-over Study on the Effects of Ursodeoxycholic Acid (UDCA) in Patients With Hepatic Sarcoidosis",TERMINATED,,PHASE2,7.0,ACTUAL,University of Pennsylvania,"Early termination due to poor recruitment in light of the COVID-19 pandemic, affecting data analysis.",2.0,,Inability to adequately recruit subjects in COVID-19 pandemic,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,OTHER,,,,,,,2022,0.0
NCT04114188,,2018-10-15,,,2021-01-28,2019-10-01,2019-10-03,ACTUAL,,,,,,,2021-01-28,2021-01-29,ACTUAL,2016-12-15,ACTUAL,2016-12-15,2021-01,2021-01-31,2020-12-31,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,RIMINI,,Tacrolimus After rATG and Infliximab Induction Immunosuppression (RIMINI),Tacrolimus After rATG and Infliximab Induction Immunosuppression (RIMINI),COMPLETED,,PHASE2,68.0,ACTUAL,"Charite University, Berlin, Germany",,1.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,OTHER,,,,,,,2020,1.0
NCT03829241,,2019-02-01,2022-12-05,2020-12-15,2024-05-06,2019-02-01,2019-02-04,ACTUAL,2022-12-05,2022-12-28,ACTUAL,2020-12-15,2020-12-21,ACTUAL,2024-05-06,2024-05-08,ACTUAL,2019-02-19,ACTUAL,2019-02-19,2024-05,2024-05-31,2020-05-08,ACTUAL,2020-05-08,2020-01-14,ACTUAL,2020-01-14,,INTERVENTIONAL,,Treated participants in the randomization phase: Enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).,Randomized Trial of Adult Participants With Generalized Anxiety Disorder,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial of Troriluzole in Generalized Anxiety Disorder",COMPLETED,,PHASE3,881.0,ACTUAL,"Biohaven Pharmaceuticals, Inc.",,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,INDUSTRY,,,,,,,2020,1.0
NCT04778397,,2021-02-23,,,2024-04-12,2021-03-01,2021-03-03,ACTUAL,,,,,,,2024-04-12,2024-04-15,ACTUAL,2021-07-01,ACTUAL,2021-07-01,2024-04,2024-04-30,2024-03-25,ACTUAL,2024-03-25,2024-03-25,ACTUAL,2024-03-25,,INTERVENTIONAL,ENHANCE-2,,Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated,"A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients With TP53 Mutant Acute Myeloid Leukemia",TERMINATED,,PHASE3,258.0,ACTUAL,Gilead Sciences,,3.0,,Study discontinued due to futility.,t,,,,t,t,f,,,,,,,,,NO,,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,INDUSTRY,,NCT05627466,NO_LONGER_AVAILABLE,,,,2024,0.0
NCT05361109,,2022-04-03,,,2023-08-29,2022-04-29,2022-05-04,ACTUAL,,,,,,,2023-08-29,2023-09-01,ACTUAL,2022-06-01,ACTUAL,2022-06-01,2023-08,2023-08-31,2023-03-31,ACTUAL,2023-03-31,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,,,Baricitinib for Cutaneous Dermatomyositis,An Open-Label Pilot Study to Evaluate the Efficacy and Safety of Baricitinib in Subjects With Cutaneous Dermatomyositis,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Washington,,1.0,,Difficulty recruiting subjects,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,OTHER,,,,,,,2023,0.0
NCT04119011,,2019-09-30,,,2021-02-19,2019-10-04,2019-10-08,ACTUAL,,,,,,,2021-02-19,2021-02-23,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2021-02,2021-02-28,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,,Probiotics in Women With Primary Dysmenorrhoea,A Novel Approach to Manipulate Intestinal Homeostasis in Primary Dysmenorrhoea Women: a Randomised Controlled Trial,COMPLETED,,PHASE1/PHASE2,72.0,ACTUAL,National University of Malaysia,,2.0,,,f,,,,,f,f,,,,,,20 months,,,YES,"clinical data sheet containing demographics, data collection (pain score, quality of life questionnaire, pain diary)",2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,OTHER,,,,,,,2020,0.0
NCT01101438,,2010-04-09,2022-07-07,,2023-08-18,2010-04-09,2010-04-12,ESTIMATED,2022-10-17,2022-10-18,ACTUAL,,,,2023-08-18,2023-09-13,ACTUAL,2010-08-13,ACTUAL,2010-08-13,2023-08,2023-08-31,2023-08-18,ACTUAL,2023-08-18,2021-09-21,ACTUAL,2021-09-21,,INTERVENTIONAL,,All randomized patients will be analyzed according to the arm that they were randomized to (intent to treat population).,A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer,A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer,COMPLETED,,PHASE3,3649.0,ACTUAL,Canadian Cancer Trials Group,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:18:42.088834,2024-10-16 02:18:42.088834,NETWORK,,,,,,,2023,1.0
NCT04740905,,2021-02-03,2023-11-22,2023-06-02,2024-07-11,2021-02-03,2021-02-05,ACTUAL,2023-12-20,2024-01-18,ACTUAL,,2024-01-18,ACTUAL,2024-07-11,2024-08-06,ACTUAL,2021-03-02,ACTUAL,2021-03-02,2024-07,2024-07-31,2023-06-12,ACTUAL,2023-06-12,2022-07-06,ACTUAL,2022-07-06,,INTERVENTIONAL,BALATON,"ITT Population: All global participants who were randomized in the study, according to the assigned treatment.",A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion,"A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion",COMPLETED,,PHASE3,553.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing",2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,INDUSTRY,,,,,,,2023,1.0
NCT04738123,,2021-02-01,,2023-10-27,2023-10-27,2021-02-01,2021-02-04,ACTUAL,,,,,2023-10-31,ACTUAL,2023-10-27,2023-10-31,ACTUAL,2021-04-06,ACTUAL,2021-04-06,2023-10,2023-10-31,2022-12-07,ACTUAL,2022-12-07,2022-11-29,ACTUAL,2022-11-29,,INTERVENTIONAL,,,A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-3),"A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adults With DSM-5 Schizophrenia",COMPLETED,,PHASE3,256.0,ACTUAL,Karuna Therapeutics,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,INDUSTRY,,,,,,,2022,0.0
NCT03625687,,2018-07-30,2023-02-02,,2023-04-04,2018-08-07,2018-08-10,ACTUAL,2023-04-04,2023-04-25,ACTUAL,,,,2023-04-04,2023-04-25,ACTUAL,2019-02-05,ACTUAL,2019-02-05,2023-04,2023-04-30,2022-04-04,ACTUAL,2022-04-04,2022-04-04,ACTUAL,2022-04-04,,INTERVENTIONAL,,Subjects receiving HCV RNA positive lung transplant and initiating treatment with DAA,Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant,Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant,TERMINATED,,PHASE4,19.0,ACTUAL,Massachusetts General Hospital,"Study was terminated prior to completion and prior to meeting enrollment goal primarily due to lack of resources (staffing and funding) and transition of HCV-positive to HCV-negative lung transplants to standard of care. Full planned analysis was not completed due to enrollment number, however primary endpoint was assessed for all 16 subjects receiving treatment.",1.0,,"Lack of funding, transitioned to standard of care",f,,,,f,t,f,,,f,,,Anticipate data would be available to share within 6 months after the final patient completes the study.,Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.,,YES,Anticipate to share coded data with collaborators,2024-10-16 02:24:14.894168,2024-10-16 02:24:14.894168,OTHER,,,,,,,2022,0.0
NCT04764851,,2021-01-18,,,2021-05-20,2021-02-18,2021-02-21,ACTUAL,,,,,,,2021-05-20,2021-05-24,ACTUAL,2021-02-18,ACTUAL,2021-02-18,2021-04,2021-04-30,2021-05-07,ACTUAL,2021-05-07,2021-04-02,ACTUAL,2021-04-02,,INTERVENTIONAL,,,Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates,"A Phase 1, Open-Label, Fixed Sequence Drug-Drug Interaction Study to Evaluate the Effects of Repeat Doses of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport in Healthy Subjects",TERMINATED,,PHASE1,30.0,ACTUAL,Emalex Biosciences Inc.,,3.0,,A number of subjects withdrew consent leaving the study without adequate power to achieve its primary end points.,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 02:24:14.894168,2024-10-16 02:24:14.894168,INDUSTRY,,,,,,,2021,0.0
NCT05320393,,2022-03-22,2024-06-28,,2024-08-13,2022-04-01,2022-04-11,ACTUAL,2024-08-13,2024-09-04,ACTUAL,,,,2024-08-13,2024-09-04,ACTUAL,2022-03-30,ACTUAL,2022-03-30,2024-06,2024-06-30,2023-05-22,ACTUAL,2023-05-22,2023-05-22,ACTUAL,2023-05-22,,INTERVENTIONAL,,,Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines,"Phase II Multi-Ctr, Prospective, Randomized, Double Blind, Active-Controlled Single Treatment Increasing Dose Trial to Study Safety & Duration of Effect of 40U of PrabotulinumtoxinA-xvfs in Adult Subjects for Treatment of Glabellar Lines",COMPLETED,,PHASE2,154.0,ACTUAL,"Evolus, Inc.",,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,INDUSTRY,,,,,,,2023,1.0
NCT00118209,,2005-07-08,2020-04-06,,2021-11-15,2005-07-08,2005-07-11,ESTIMATED,2020-04-06,2020-04-17,ACTUAL,,,,2021-11-15,2021-11-17,ACTUAL,2005-05,ACTUAL,2005-05-31,2021-11,2021-11-30,2021-11-15,ACTUAL,2021-11-15,2017-10,ACTUAL,2017-10-31,,INTERVENTIONAL,,Participants who completed the study in the Participant Flow are included in this analysis.,Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma,Phase III Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R With Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas,COMPLETED,,PHASE3,524.0,ACTUAL,Alliance for Clinical Trials in Oncology,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,OTHER,,,,,,,2021,1.0
NCT03297463,,2017-09-26,,,2018-07-30,2017-09-26,2017-09-29,ACTUAL,,,,,,,2018-07-30,2018-08-01,ACTUAL,2018-01-31,ACTUAL,2018-01-31,2018-07,2018-07-31,2020-02-01,ESTIMATED,2020-02-01,2020-02-01,ESTIMATED,2020-02-01,,INTERVENTIONAL,,,Radiation Therapy With Combination Immunotherapy for Relapsed/Refractory Metastatic Melanoma,A Phase 1b/2 Study of Hypofractionated Radiation and Combination Immunotherapy for Relapsed/Refractory Metastatic Melanoma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Masonic Cancer Center, University of Minnesota",,2.0,,Replaced by another study.,f,,,,,t,f,,,,,,,,,,,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,OTHER,,,,,,,2020,0.0
NCT02145949,,2014-05-19,2022-10-15,,2024-07-20,2014-05-22,2014-05-23,ESTIMATED,2024-07-20,2024-07-23,ACTUAL,,,,2024-07-20,2024-07-23,ACTUAL,2014-12,ACTUAL,2014-12-31,2024-07,2024-07-31,2020-02,ACTUAL,2020-02-29,2020-02,ACTUAL,2020-02-29,,INTERVENTIONAL,,31 subjects in EAA group began study and 19 completed study. 36 subjects in placebo group began study and 20 completed study.,Mechanistic Approach to Preventing Atrophy and Restoring Function in Older Adults,Mechanistic Approach to Preventing Atrophy and Restoring Function in Older Adults,COMPLETED,,PHASE2,80.0,ACTUAL,University of Oregon,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,OTHER,,,,,,,2020,1.0
NCT05346653,,2022-04-20,2023-11-15,,2024-08-12,2022-04-20,2022-04-26,ACTUAL,2023-11-15,2023-12-06,ACTUAL,,,,2024-08-12,2024-09-04,ACTUAL,2023-05-22,ACTUAL,2023-05-22,2024-08,2024-08-31,2023-05-23,ACTUAL,2023-05-23,2023-05-23,ACTUAL,2023-05-23,,INTERVENTIONAL,,1 subject consented to the study but was not randomized.,The Hemodynamic Effects of SGLT2i in Acute Decompensated Heart Failure,The Hemodynamic Effects of Sodium-Glucose Co-Transporter 2 Inhibitors (SGLT2i) in Acute Decompensated Heart Failure,TERMINATED,,PHASE4,1.0,ACTUAL,University of Chicago,,2.0,,Enrollment goals were not met.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,OTHER,,,,,,,2023,0.0
NCT03817554,,2019-01-11,,,2021-11-28,2019-01-23,2019-01-25,ACTUAL,,,,,,,2021-11-28,2021-12-09,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2021-11,2021-11-30,2020-08-31,ACTUAL,2020-08-31,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,,,Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients,A Randomized Controlled Trial of Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients,TERMINATED,,PHASE4,21.0,ACTUAL,Peking University First Hospital,,2.0,,The recruitment of participants in the study was difficulty.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 02:24:14.894168,2024-10-16 02:24:14.894168,OTHER,,,,,,,2020,0.0
NCT05308602,,2022-02-15,,,2024-02-07,2022-04-01,2022-04-04,ACTUAL,,,,,,,2024-02-07,2024-02-09,ACTUAL,2022-04-01,ESTIMATED,2022-04-01,2022-03,2022-03-31,2023-08-01,ESTIMATED,2023-08-01,2022-08-01,ESTIMATED,2022-08-01,,INTERVENTIONAL,,,A Study to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E (Two Recombinant Protein COVID-19 Vaccines) in Population Aged ≥12 Years,"A Randomized, Double-blinded, Active-controlled Phase II Clinical Study to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) and SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥12 Years and Previously Unvaccinated",WITHDRAWN,,PHASE2,0.0,ACTUAL,Sinocelltech Ltd.,,4.0,,There was not a need any more.,f,,,,,f,f,,,,,,,,,,,2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,INDUSTRY,,,,,,,2023,0.0
NCT05161533,,2021-12-01,,,2023-10-16,2021-12-15,2021-12-17,ACTUAL,,,,,,,2023-10-16,2023-10-18,ACTUAL,2023-10-19,ESTIMATED,2023-10-19,2023-04,2023-04-30,2024-12-31,ESTIMATED,2024-12-31,2024-10-01,ESTIMATED,2024-10-01,,INTERVENTIONAL,,,"Hypofractionated Radiation Therapy After Durvalumab and Chemotherapy for the Treatment of Stage IV Extensive Stage Small Cell Lung Cancer, CASPIAN-RT Trial",CASPIAN-RT Trial: Hypofractionated Consolidative Radiation Therapy After Durvalumab (MEDI4736) Plus Platinum-Based Chemotherapy in Extensive Stage Small Cell Lung Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Washington,,1.0,,Closed per SRC Low Accrual Policy. Study closed prior to any participants enrolled.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:24:14.894168,2024-10-16 02:24:14.894168,OTHER,,,,,,,2024,0.0
NCT03086395,,2017-03-16,,,2017-03-16,2017-03-16,2017-03-22,ACTUAL,,,,,,,2017-03-16,2017-03-22,ACTUAL,2017-04-01,ESTIMATED,2017-04-01,2017-03,2017-03-31,2021-01-01,ESTIMATED,2021-01-01,2018-01-01,ESTIMATED,2018-01-01,,INTERVENTIONAL,,,Single Agent Obinutuzumab in Relapsed/Refractory Post-Transplant Lymphoproliferative Disorder (PTLD),Phase II Study of Single Agent Obinutuzumab in Relapsed/Refractory Post-Transplant Lymphoproliferative Disorder (PTLD),WITHDRAWN,,PHASE2,0.0,ACTUAL,Case Comprehensive Cancer Center,,1.0,,Funding Unavailable,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 02:24:14.894168,2024-10-16 02:24:14.894168,OTHER,,,,,,,2021,0.0
NCT03834220,,2019-02-04,2023-11-29,2021-12-24,2024-01-12,2019-02-06,2019-02-07,ACTUAL,2024-01-12,2024-02-07,ACTUAL,,2024-02-07,ACTUAL,2024-01-12,2024-02-07,ACTUAL,2019-03-22,ACTUAL,2019-03-22,2024-01,2024-01-31,2022-01-04,ACTUAL,2022-01-04,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,Intent-to-treat (ITT) Population consisted of all participants who received study drug.,"Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)","A Phase II Basket Study of the Oral Selective Pan-FGFR Inhibitor Debio 1347 in Subjects With Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3",TERMINATED,,PHASE2,63.0,ACTUAL,Debiopharm International SA,"Limitations of the trial such as small numbers of participants analyzed or technical problems leading to unreliable data.~Due to the premature termination of participant recruitment and shortened follow-up, the primary efficacy analysis was likely underpowered in the final analysis, leading to greater statistical uncertainty in results.",3.0,,Due to lower antitumor activity than expected,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,INDUSTRY,,,,,,,2022,0.0
NCT05098067,,2021-10-20,2023-05-24,,2024-02-05,2021-10-20,2021-10-28,ACTUAL,2024-02-05,2024-02-07,ACTUAL,,,,2024-02-05,2024-02-07,ACTUAL,2022-05-24,ACTUAL,2022-05-24,2024-02,2024-02-29,2023-03-01,ACTUAL,2023-03-01,2022-10-17,ACTUAL,2022-10-17,,INTERVENTIONAL,,,Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy,Trial of Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy: A Pilot Investigation,COMPLETED,,PHASE2,30.0,ACTUAL,Women and Infants Hospital of Rhode Island,,2.0,,,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,OTHER,,,,,,,2023,1.0
NCT04203537,,2019-12-16,2021-08-13,,2024-04-15,2019-12-16,2019-12-18,ACTUAL,2021-12-17,2022-01-12,ACTUAL,,,,2024-04-15,2024-05-08,ACTUAL,2019-12-04,ACTUAL,2019-12-04,2024-04,2024-04-30,2020-10-26,ACTUAL,2020-10-26,2020-10-26,ACTUAL,2020-10-26,,INTERVENTIONAL,,"1 subject was randomized to CA-008 60 mg, but actually received placebo~1 subject was randomized to CA-008 36 mg, but actually received placebo~Both subjects are included in the placebo arm","Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)","A Two-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics and Preliminary Efficacy Study of CA-008 in Patients Undergoing Total Knee Arthroplasy",COMPLETED,,PHASE1/PHASE2,193.0,ACTUAL,Concentric Analgesics,,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:18:40.354512,2024-10-15 15:18:40.354512,INDUSTRY,,,,,,,2020,1.0
NCT02790138,,2016-05-26,2021-06-09,,2022-02-01,2016-05-31,2016-06-03,ESTIMATED,2021-06-09,2021-06-30,ACTUAL,,,,2022-02-01,2022-02-24,ACTUAL,2016-10-12,ACTUAL,2016-10-12,2022-02,2022-02-28,2021-02-02,ACTUAL,2021-02-02,2020-06-11,ACTUAL,2020-06-11,,INTERVENTIONAL,EARNEST,"Full Analysis Set included all randomized participants who received at least 1 dose of study medication, as randomized.",A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis,"A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST)",COMPLETED,,PHASE4,102.0,ACTUAL,Takeda,,2.0,,,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 02:24:14.894168,2024-10-16 02:24:14.894168,INDUSTRY,,,,,,,2021,1.0
NCT01754857,,2012-11-09,2023-05-18,,2023-06-26,2012-12-18,2012-12-21,ESTIMATED,2023-06-26,2023-06-27,ACTUAL,,,,2023-06-26,2023-06-27,ACTUAL,2013-11-12,ACTUAL,2013-11-12,2023-06,2023-06-30,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,,Bendamustine and Rituximab Induction Therapy and Maintenance Rituximab and Lenalidomide in Previously Untreated CLL/SLL,Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy Followed by Maintenance Rituximab and Lenalidomide in Previously Untreated Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL),COMPLETED,,PHASE2,36.0,ACTUAL,"University of Wisconsin, Madison",,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 02:24:14.894168,2024-10-16 02:24:14.894168,OTHER,,,,,,,2022,0.0
NCT04348006,,2020-04-13,,,2023-04-26,2020-04-13,2020-04-15,ACTUAL,,,,,,,2023-04-26,2023-04-28,ACTUAL,2020-03-01,ACTUAL,2020-03-01,2023-04,2023-04-30,2021-07-30,ESTIMATED,2021-07-30,2021-07-30,ESTIMATED,2021-07-30,,INTERVENTIONAL,MM,,Assessment of Bortezomib (Alvocade ®) Efficacy and Safety in Newly Diagnosed Multiple Myeloma Patients,Assessment of Bortezomib (Alvocade ®) Efficacy and Safety in Newly Diagnosed Multiple Myeloma Patients,WITHDRAWN,,PHASE4,0.0,ACTUAL,Al-Rasheed University College,,1.0,,No patients were enrolled in the study,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,OTHER,,,,,,,2021,0.0
NCT04352075,,2020-04-15,,,2020-04-17,2020-04-16,2020-04-17,ACTUAL,,,,,,,2020-04-17,2020-04-20,ACTUAL,2018-11-15,ACTUAL,2018-11-15,2020-04,2020-04-30,2020-03-01,ACTUAL,2020-03-01,2019-08-01,ACTUAL,2019-08-01,,INTERVENTIONAL,MICROPREP,,Intra Articular Injection of Microfat and PRP in Knee Osteoarthritis,Intra Articular Injection of Autologous Microfat and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis: a Pilot Study,COMPLETED,,PHASE1/PHASE2,30.0,ACTUAL,Clinique Juge,,3.0,,,f,,,,t,f,f,,,,,,,,,NO,Publication,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,OTHER,,,,,,,2020,1.0
NCT04102436,,2019-09-24,,,2024-03-08,2019-09-24,2019-09-25,ACTUAL,,,,,,,2024-03-08,2024-03-12,ACTUAL,2024-03-08,ACTUAL,2024-03-08,2024-03,2024-03-31,2024-03-08,ACTUAL,2024-03-08,2024-03-08,ACTUAL,2024-03-08,,INTERVENTIONAL,,,Non-Viral TCR Gene Therapy,A Phase II Study Using the Administration of Autologous T-Cells Engineered Using the Sleeping Beauty Transposon/Transposase System to Express T-Cell Receptors Reactive Against Mutated Neoantigens in Patients With Metastatic Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,Difficulty with availability of GLP-grade reagents for manufacturing.,f,,,,,t,f,,,,,,Clinical data available during the study and indefinitely.,Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.,,YES,.All IPD recorded in the medical record will be shared with intramural investigators upon request.,2024-10-15 15:18:40.354512,2024-10-15 15:18:40.354512,NIH,,,,,,,2024,0.0
NCT04549376,,2020-09-11,,,2022-01-10,2020-09-12,2020-09-16,ACTUAL,,,,,,,2022-01-10,2022-01-25,ACTUAL,2020-07-01,ACTUAL,2020-07-01,2022-01,2022-01-31,2020-10-30,ACTUAL,2020-10-30,2020-10-20,ACTUAL,2020-10-20,,INTERVENTIONAL,VEP-COV,,Virucidal Effect of Povidone Iodine on COVID-19 In-Vivo,Virucidal Effect of Povidone Iodine on COVID-19 In-Vivo: an Open Label Randomized Clinical Trial,COMPLETED,,PHASE2,200.0,ACTUAL,Bangladesh Reference Institute of Chemical Measurements (BRICM),,7.0,,,f,,,,t,f,f,,,f,,,6 months,"Available on public domain like figshare, researchgate and others",,YES,"After completion of the project, a manuscript will be prepared and will be shared to the journal authority for publication. Data will be shared with the journal authority and make public as part of the publication.",2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,OTHER_GOV,,,,,,,2020,1.0
NCT04837807,,2021-04-06,2022-03-07,,2022-10-06,2021-04-06,2021-04-08,ACTUAL,2022-10-06,2022-10-10,ACTUAL,,,,2022-10-06,2022-10-10,ACTUAL,2021-08-18,ACTUAL,2021-08-18,2022-10,2022-10-31,2021-11-19,ACTUAL,2021-11-19,2021-11-19,ACTUAL,2021-11-19,,INTERVENTIONAL,,,Digital Device Users Who Are Treated With Systane Hydration PF,Understanding Quality of Life in High Digital Device Users Who Are Treated With Systane Hydration PF,COMPLETED,,PHASE4,30.0,ACTUAL,University of Alabama at Birmingham,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,OTHER,,,,,,,2021,1.0
NCT04170023,,2019-11-06,2024-06-11,,2024-07-16,2019-11-18,2019-11-20,ACTUAL,2024-07-16,2024-08-09,ACTUAL,,,,2024-07-16,2024-08-09,ACTUAL,2019-12-16,ACTUAL,2019-12-16,2024-07,2024-07-31,2024-03-20,ACTUAL,2024-03-20,2023-04-27,ACTUAL,2023-04-27,,INTERVENTIONAL,,Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study.,Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH Patients as Monotherapy,"A Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of the Oral Factor D (FD) Inhibitor ALXN2050 (ACH-0145228) in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy",TERMINATED,,PHASE2,29.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,1.0,,Did not appropriately control IVH; significantly increased rates of BTH and LDH excursions (LDH excursions is defined by LDH values \> X2ULN) compared to ravulizumab.,f,,,,f,t,f,,,,,,,,,YES,"Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.",2024-10-16 11:46:44.64325,2024-10-16 11:46:44.64325,INDUSTRY,,,,,,,2024,0.0
NCT05032118,,2021-08-20,,,2023-04-27,2021-08-26,2021-09-02,ACTUAL,,,,,,,2023-04-27,2023-05-01,ACTUAL,2023-04-27,ACTUAL,2023-04-27,2023-04,2023-04-30,2023-04-27,ACTUAL,2023-04-27,2023-04-27,ACTUAL,2023-04-27,,INTERVENTIONAL,PENDULUM,,Pilot Study of Ketamine Sedation for Aneurysmal Subarachnoid Hemorrhage,"A Pilot Study of Ketamine Sedation Initiated Early After Aneurysmal Subarachnoid Hemorrhage: Effect on Vasospasm, Delayed Cerebral Ischemia, and Functional Outcomes",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Oregon Health and Science University,,2.0,,"Institution change, no IRB approval",f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 15:18:40.354512,2024-10-15 15:18:40.354512,OTHER,,,,,,,2023,0.0
NCT00659776,,2008-04-10,2023-08-01,,2024-01-16,2008-04-15,2008-04-16,ESTIMATED,2024-01-16,2024-01-30,ACTUAL,,,,2024-01-16,2024-01-30,ACTUAL,2004-07,ACTUAL,2004-07-31,2024-01,2024-01-31,2021-12,ACTUAL,2021-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,,"The study was terminated early due to Covid and funding shortages. Therefore, subject enrollment was not met, and no subjects were enrolled in group 3.","MR, Histologic And EM Imaging Of Intravenous Ferumoxytol In Central Nervous System (CNS) Inflammation","Multi-Disciplinary Study: Magnetic Resonance, Histologic And Electron Microscopy Imaging Of Intravenous Superparamagnetic Crystalline Particles (Ferumoxytol) In CNS Inflammation",TERMINATED,,PHASE2,255.0,ACTUAL,Oregon Health and Science University,,3.0,,Due to staffing shortages and lack of funding during Covid.,f,,,,t,,,,,,,,,,,,,2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,OTHER,,,,,,,2021,0.0
NCT03659136,,2018-09-03,2022-08-10,,2024-06-17,2018-09-03,2018-09-06,ACTUAL,2022-09-15,2022-09-29,ACTUAL,,,,2024-06-17,2024-07-10,ACTUAL,2018-11-28,ACTUAL,2018-11-28,2024-06,2024-06-30,2022-05-11,ACTUAL,2022-05-11,2021-08-30,ACTUAL,2021-08-30,,INTERVENTIONAL,,"Randomised Set (RS): The randomised set included all randomised patients, regardless of whether they received treatment or not.",The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread,"XENERA™1: A Multi-centre, Double-blind, Placebo-controlled, Randomised Phase II Trial to Compare Efficacy of Xentuzumab in Combination With Everolimus and Exemestane Versus Everolimus and Exemestane in Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease",COMPLETED,,PHASE2,103.0,ACTUAL,Boehringer Ingelheim,,2.0,,,,,,,t,t,f,,,,,,"One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.",https://www.mystudywindow.com/msw/datasharing,YES,"Once the criteria in section Time Frame are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.",2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,INDUSTRY,,,,,,,2022,1.0
NCT04570501,,2020-09-28,,,2022-02-15,2020-09-28,2020-09-30,ACTUAL,,,,,,,2022-02-15,2022-03-03,ACTUAL,2022-02,ESTIMATED,2022-02-28,2022-02,2022-02-28,2022-08,ESTIMATED,2022-08-31,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,,,Angiotensin (1-7) for the Treatment of COVID-19 in Hospitalized Patients,"A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety and Efficacy of Angiotensin (1-7) for the Treatment of COVID-19 in Hospitalized Patients",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Stanford University,,2.0,,Discontinuation of drug candidates,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:24:14.894168,2024-10-16 02:24:14.894168,OTHER,,,,,,,2022,0.0
NCT02647255,,2015-12-21,,,2021-09-30,2016-01-04,2016-01-06,ESTIMATED,,,,,,,2021-09-30,2021-10-08,ACTUAL,2016-03,ACTUAL,2016-03-31,2021-09,2021-09-30,2020-10,ACTUAL,2020-10-31,2020-10,ACTUAL,2020-10-31,,INTERVENTIONAL,RESCUE,,Trial of Plasma Exchange for Severe Crescentic IgA Nephropathy,Randomized Trial of Plasma Exchange as Adjunctive Therapy for Severe Crescentic GlomerUlonephritis of IgA NEphropathy (RESCUE Study),TERMINATED,,PHASE2/PHASE3,10.0,ACTUAL,Peking University First Hospital,,2.0,,"Due to the rarity and rapid progressive course of the disease, patients were less likely to participate in randomization.",f,,,,t,,,,,,,,,,,,,2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,OTHER,,,,,,,2020,0.0
NCT05156658,,2021-12-01,,,2023-08-08,2021-12-01,2021-12-14,ACTUAL,,,,,,,2023-08-08,2023-08-09,ACTUAL,2024-01-01,ESTIMATED,2024-01-01,2023-08,2023-08-31,2024-08-02,ESTIMATED,2024-08-02,2024-08-02,ESTIMATED,2024-08-02,,INTERVENTIONAL,,,Pharmacokinetic Interactions of ENG Subdermal Implants With Long-Acting Cabotegravir (CAB-LA) and LA Rilpivirine (RPV-LA) (CARLA),Pharmacokinetic Interactions of Etonogestrel (ENG) Subdermal Implants With Long-Acting (LA) Cabotegravir (CAB-LA) and LA Rilpivirine (RPV-LA) (CARLA) in Participants of Reproductive Potential,WITHDRAWN,,PHASE4,0.0,ACTUAL,Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections,,2.0,,Protocol's question was answered elsewhere and very low site interest in the trial,f,,,,t,t,f,,,t,,,Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.,* With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism will data be made available? Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at: https://actgnetwork.org/about-actg/templates-and-forms. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.,,YES,"Individual participant data that underlie results in the publication, after deidentification.",2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,NETWORK,,,,,,,2024,0.0
NCT04969991,,2021-07-08,,2023-02-06,2023-08-03,2021-07-19,2021-07-21,ACTUAL,,,,2023-02-06,2023-02-10,ACTUAL,2023-08-03,2023-08-07,ACTUAL,2021-06-30,ACTUAL,2021-06-30,2023-08,2023-08-31,2022-11-22,ACTUAL,2022-11-22,2022-02-11,ACTUAL,2022-02-11,,INTERVENTIONAL,STAIRS,,Study of Varespladib in Patients Hospitalized With Severe COVID-19,"A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Varespladib in Patients Hospitalized With Severe COVID 19 Caused by SARS-CoV-2",TERMINATED,,PHASE2,18.0,ACTUAL,"Ophirex, Inc.",,6.0,,"Part 2 of the study was paused on 03-May-2022 due to slow enrollment following low infection rates and hospitalizations of patients with severe COVID-19, and did not recommence prior to study closure (early termination) on 22-Nov-2022.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 11:52:32.973311,2024-10-16 11:52:32.973311,INDUSTRY,,,,,,,2022,0.0
NCT04456998,,2020-06-30,2023-10-16,,2023-10-16,2020-06-30,2020-07-07,ACTUAL,2023-10-16,2023-11-07,ACTUAL,,,,2023-10-16,2023-11-07,ACTUAL,2020-11-12,ACTUAL,2020-11-12,2023-10,2023-10-31,2022-11-01,ACTUAL,2022-11-01,2022-10-17,ACTUAL,2022-10-17,,INTERVENTIONAL,,,GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH),"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)",COMPLETED,,PHASE2,86.0,ACTUAL,Gossamer Bio Inc.,,2.0,,,f,,,,t,t,t,,,,,,,,,NO,,2024-10-16 11:52:32.973311,2024-10-16 11:52:32.973311,INDUSTRY,,,,,,,2022,1.0
NCT04222842,,2020-01-07,,,2021-03-07,2020-01-07,2020-01-10,ACTUAL,,,,,,,2021-03-07,2021-03-10,ACTUAL,2019-12-18,ACTUAL,2019-12-18,2021-03,2021-03-31,2021-12-30,ESTIMATED,2021-12-30,2021-12-30,ESTIMATED,2021-12-30,,INTERVENTIONAL,,,CM082 in Patients With Myopic Choroidal Neovascularization (CNV),Phase I Study of CM082 in Patients With Myopic Choroidal Neovascularization (CNV),SUSPENDED,,PHASE1,96.0,ESTIMATED,AnewPharma,,1.0,,Day is not required for Anticipated dates.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,INDUSTRY,,,,,,,2021,0.0
NCT04163900,,2019-11-01,2023-03-02,,2023-05-22,2019-11-12,2019-11-15,ACTUAL,2023-05-22,2023-05-24,ACTUAL,,,,2023-05-22,2023-05-24,ACTUAL,2019-12-24,ACTUAL,2019-12-24,2023-05,2023-05-31,2022-04-05,ACTUAL,2022-04-05,2022-03-02,ACTUAL,2022-03-02,,INTERVENTIONAL,,Intent-to-treat,Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer,"A Phase III Open-Label, Multi-Centre, Randomized Study Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Previously Untreated Locally Advanced or Metastatic Biliary Tract Cancer",TERMINATED,,PHASE3,773.0,ACTUAL,NuCana plc,"At Interim Analysis 1, the futility boundary for OS was crossed and the study was closed on 02 Mar 2022. Following study closure, data from the 05 April 2022 final data cut-off (30 day follow-up post the last patient last visit) were analysed. In general, the analyses performed on this final database were those that were scheduled to take place at Interim Analysis 2. However, any p-values or CIs obtained are only viewed as descriptive as the study was stopped for futility.",2.0,,"A pre-planned futility analysis concluded that NUC-1031 plus cisplatin was unlikely to achieve its primary objective of improving overall survival. Based on the IDMC's recommendation, NuCana has closed the study.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:24:14.894168,2024-10-16 02:24:14.894168,OTHER,,,,,,,2022,0.0
NCT03471507,,2018-03-14,2023-08-22,,2023-08-22,2018-03-14,2018-03-20,ACTUAL,2023-08-22,2023-09-18,ACTUAL,,,,2023-08-22,2023-09-18,ACTUAL,2020-12-15,ACTUAL,2020-12-15,2023-08,2023-08-31,2022-09-22,ACTUAL,2022-09-22,2022-09-22,ACTUAL,2022-09-22,,INTERVENTIONAL,,,Bonipar for Acute and Chronic Musculoskeletal Pain,Efficacy of a Topical Pain Relief Spray Containing Herbal Oil Extracts (Bonipar) Among Individuals With Acute and Chronic Musculoskeletal Pain,COMPLETED,,PHASE2,164.0,ACTUAL,Duke University,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 11:52:32.973311,2024-10-16 11:52:32.973311,OTHER,,,,,,,2022,1.0
NCT02774005,,2016-05-12,2022-08-15,,2023-03-31,2016-05-13,2016-05-16,ESTIMATED,2023-03-31,2023-04-21,ACTUAL,,,,2023-03-31,2023-04-21,ACTUAL,2016-05,,2016-05-31,2023-03,2023-03-31,2021-03-29,ACTUAL,2021-03-29,2021-03-29,ACTUAL,2021-03-29,,INTERVENTIONAL,LEROS,A total of 199 patients were enrolled in the study. 198 received treatment and were included in the Safety Population. There were 196 patients in the ITT population. A total of 181 patients were included in the mITT population.,Study to Assess the Efficacy and Safety of Raxone in LHON Patients,"External Natural History Controlled, Open-Label Intervention Study to Assess the Efficacy and Safety of Long-Term Treatment With Raxone® in Leber's Hereditary Optic Neuropathy (LHON)",COMPLETED,,PHASE4,199.0,ACTUAL,Santhera Pharmaceuticals,,1.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,INDUSTRY,,,,,,,2021,1.0
NCT03692221,,2018-09-24,,,2022-04-28,2018-09-28,2018-10-02,ACTUAL,,,,,,,2022-04-28,2022-05-05,ACTUAL,2019-06,ESTIMATED,2019-06-30,2022-04,2022-04-30,2022-09-30,ESTIMATED,2022-09-30,2021-09-30,ESTIMATED,2021-09-30,,INTERVENTIONAL,,,Mesenchymal Stem Cells for Lumbar Degenerative Disc Disease,Percutaneous Image Guided Delivery of Autologous Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Symptomatic Degenerated Intervertebral Disc Disease,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University Hospitals Cleveland Medical Center,,3.0,,Stalled due to Covid,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:18:40.354512,2024-10-15 15:18:40.354512,OTHER,,,,,,,2022,0.0
NCT04530487,,2020-08-25,,,2024-08-30,2020-08-25,2020-08-28,ACTUAL,,,,,,,2024-08-30,2024-09-04,ACTUAL,2020-08-19,ACTUAL,2020-08-19,2024-08,2024-08-31,2024-08-26,ACTUAL,2024-08-26,2024-08-26,ACTUAL,2024-08-26,,INTERVENTIONAL,,,Donor Stem Cell Transplant After Chemotherapy for the Treatment of Recurrent or Refractory High-Risk Solid Tumors in Pediatric and Adolescent-Young Adults,A Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Pediatric and Adolescent-Young Adults Patients with High Risk Solid Tumors,TERMINATED,,PHASE2,1.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,PI Request,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,OTHER,,,,,,,2024,0.0
NCT04096716,,2019-09-18,,,2023-12-14,2019-09-18,2019-09-20,ACTUAL,,,,,,,2023-12-14,2023-12-21,ACTUAL,2019-12-03,ACTUAL,2019-12-03,2023-12,2023-12-31,2022-04-30,ACTUAL,2022-04-30,2022-04-30,ACTUAL,2022-04-30,,INTERVENTIONAL,,,Mapping Draining Lymph Nodes in CNS Malignancies,Mapping Draining Lymph Nodes in CNS Malignancies,TERMINATED,,PHASE1,14.0,ACTUAL,Washington University School of Medicine,,6.0,,Insufficient funding/staff,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 11:52:32.973311,2024-10-16 11:52:32.973311,OTHER,,,,,,,2022,0.0
NCT02325414,,2014-12-21,2021-03-17,,2021-06-08,2014-12-24,2014-12-25,ESTIMATED,2021-05-07,2021-06-02,ACTUAL,,,,2021-06-08,2021-06-29,ACTUAL,2015-02,ACTUAL,2015-02-28,2021-06,2021-06-30,2020-08-25,ACTUAL,2020-08-25,2020-08-25,ACTUAL,2020-08-25,,INTERVENTIONAL,,,Prevention of Bone Loss After Acute SCI by Zoledronic Acid,"Prevention of Bone Loss After Acute SCI by Zoledronic Acid: Durability, Effect on Bone Strength, and Use of Biomarkers to Guide Therapy",COMPLETED,,PHASE2,60.0,ACTUAL,Northwestern University,"The number of participants in the trial was limited, particularly during the second year in each subgroup. Additionally, the number of women studied was limited but was representative of the general sex distribution observed in people with spinal cord injury.",2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 11:52:32.973311,2024-10-16 11:52:32.973311,OTHER,,,,,,,2020,1.0
NCT03424122,,2018-01-25,,,2022-06-27,2018-01-31,2018-02-06,ACTUAL,,,,,,,2022-06-27,2022-06-29,ACTUAL,2018-07-02,ACTUAL,2018-07-02,2022-06,2022-06-30,2022-06-27,ACTUAL,2022-06-27,2022-06-27,ACTUAL,2022-06-27,,INTERVENTIONAL,,,"INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)","A Phase 1, Open-Label, Dose-Finding Study of INCB050465 in Combination With Investigator Choice of Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)",COMPLETED,,PHASE1,50.0,ACTUAL,Incyte Corporation,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,INDUSTRY,,,,,,,2022,1.0
NCT02872272,,2016-08-16,,,2024-06-27,2016-08-16,2016-08-19,ESTIMATED,,,,,,,2024-06-27,2024-07-01,ACTUAL,2020-01-06,ACTUAL,2020-01-06,2024-06,2024-06-30,2021-07-09,ACTUAL,2021-07-09,2021-07-09,ACTUAL,2021-07-09,,INTERVENTIONAL,AMIKACINE,,Amikacin Pharmacokinetic Profile in Plasma and Tissue After an Administration Using Impregnated Dressings in Burned Patient Population,Amikacin Pharmacokinetic Profile in Plasma and Tissue After an Administration Using Impregnated Dressings in Burned Patient Population,TERMINATED,,PHASE4,7.0,ACTUAL,Assistance Publique Hopitaux De Marseille,,1.0,,not enough participants to include,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,OTHER,,,,,,,2021,0.0
NCT03428126,,2018-02-05,2023-04-13,,2023-06-12,2018-02-05,2018-02-09,ACTUAL,2023-06-12,2023-06-15,ACTUAL,,,,2023-06-12,2023-06-15,ACTUAL,2018-03-21,ACTUAL,2018-03-21,2023-06,2023-06-30,2022-05-05,ACTUAL,2022-05-05,2022-05-05,ACTUAL,2022-05-05,,INTERVENTIONAL,,,Study of Durvalumab (MEDI4736) (Anti-PD-L1) and Trametinib (MEKi) in MSS Metastatic Colon Cancer,Phase II Study of Durvalumab (MEDI4736) (Anti-PD-L1) and Trametinib (MEKi) in MSS Metastatic Colon Cancer,COMPLETED,,PHASE2,29.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 15:18:40.354512,2024-10-15 15:18:40.354512,OTHER,,,,,,,2022,0.0
NCT03946670,,2019-05-08,2023-04-24,,2024-08-15,2019-05-09,2019-05-13,ACTUAL,2023-07-06,2023-07-07,ACTUAL,,,,2024-08-15,2024-09-04,ACTUAL,2019-06-04,ACTUAL,2019-06-04,2024-08,2024-08-31,2024-07-03,ACTUAL,2024-07-03,2022-04-26,ACTUAL,2022-04-26,,INTERVENTIONAL,STIMULUS-MDS1,Full Analysis Set (FAS): All randomized subjects were included in the FAS (intent-to-treat population) Subject data in the FAS were analyzed according to the treatment and stratum they were assigned to when they were randomized. Efficacy.,"A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS).","A Randomized, Double-blind, Placebo-controlled Phase II Multi-center Study of Intravenous MBG453 Added to Hypomethylating Agents in Adult Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R Criteria",COMPLETED,,PHASE2,127.0,ACTUAL,Novartis,,2.0,,,f,,,,t,t,f,,,,,,,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.",https://www.clinicalstudydatarequest.com,YES,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,INDUSTRY,,,,,,,2024,1.0
NCT05038020,,2021-07-29,2023-02-16,,2023-10-09,2021-08-31,2021-09-08,ACTUAL,2023-10-09,2023-11-01,ACTUAL,,,,2023-10-09,2023-11-01,ACTUAL,2021-08-17,ACTUAL,2021-08-17,2023-10,2023-10-31,2022-04-19,ACTUAL,2022-04-19,2021-12-09,ACTUAL,2021-12-09,,INTERVENTIONAL,,"The study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.",A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI),"A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)",TERMINATED,,PHASE2,3.0,ACTUAL,"Alkahest, Inc.","This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on low enrollment number, no data is reported in order to protect and maintain participant privacy/confidentiality.",2.0,,Study terminated due to safety findings in other AKST4290 studies,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 02:24:14.894168,2024-10-16 02:24:14.894168,INDUSTRY,,,,,,,2022,0.0
NCT05226299,,2022-01-25,,,2022-11-02,2022-02-04,2022-02-07,ACTUAL,,,,,,,2022-11-02,2022-11-03,ACTUAL,2021-05-01,ACTUAL,2021-05-01,2022-11,2022-11-30,2022-08-30,ACTUAL,2022-08-30,2022-05-30,ACTUAL,2022-05-30,,INTERVENTIONAL,CDTPilot2,,Cough Desensitization Therapy: Pilot 2,Cough Desensitization Therapy for Cough Hypersensitivity Syndrome: Pilot 2,COMPLETED,,PHASE1,22.0,ACTUAL,University of Montana,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,OTHER,,,,,,,2022,1.0
NCT03422172,,2018-01-30,2021-04-13,,2021-05-12,2018-01-30,2018-02-05,ACTUAL,2021-05-12,2021-05-13,ACTUAL,,,,2021-05-12,2021-05-13,ACTUAL,2018-04-10,ACTUAL,2018-04-10,2021-05,2021-05-31,2020-04-20,ACTUAL,2020-04-20,2020-04-20,ACTUAL,2020-04-20,,INTERVENTIONAL,,,"A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men","An Open Label, Phase 1 Study to Evaluate the PK, Safety, Tolerability and Acceptability of Long Acting Injections of the HIV Integrase Inhibitor, Cabotegravir (CAB; GSK1265744) in HIV Uninfected Chinese Men",COMPLETED,,PHASE1,48.0,ACTUAL,ViiV Healthcare,,1.0,,,f,,,,f,t,f,,,t,,,IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 02:24:14.894168,2024-10-16 02:24:14.894168,INDUSTRY,,,,,,,2020,1.0
NCT03948646,,2019-05-10,2024-03-28,2022-01-21,2024-05-10,2019-05-10,2019-05-14,ACTUAL,2024-05-10,2024-05-21,ACTUAL,,2024-05-21,ACTUAL,2024-05-10,2024-05-21,ACTUAL,2020-12-04,ACTUAL,2020-12-04,2024-05,2024-05-31,2021-08-13,ACTUAL,2021-08-13,2021-08-13,ACTUAL,2021-08-13,,INTERVENTIONAL,CARDIGANII,Intent-to-treat,Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302),"A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied Sofpironium Bromide Gel, 15% in Subjects With Axillary Hyperhidrosis",COMPLETED,,PHASE3,351.0,ACTUAL,Botanix Pharmaceuticals,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 11:52:32.973311,2024-10-16 11:52:32.973311,INDUSTRY,,,,,,,2021,1.0
NCT03738800,,2018-10-24,2022-02-01,,2023-07-20,2018-11-08,2018-11-13,ACTUAL,2023-07-20,2023-08-14,ACTUAL,,,,2023-07-20,2023-08-14,ACTUAL,2019-05-01,ACTUAL,2019-05-01,2023-02,2023-02-28,2021-09-03,ACTUAL,2021-09-03,2021-09-03,ACTUAL,2021-09-03,,INTERVENTIONAL,,,"A Safety, Efficacy and Systemic Exposure Study of CD5789 Cream in Adults and Adolescents With Lamellar Ichthyosis","A Phase 2 Randomized, Multicenter, Double-blind, Vehicle Controlled, 90-Day, Safety, Efficacy & Systemic Exposure Study of Trifarotene (CD5789) Cream HE1 in Adults and Adolescents With Autosomal Recessive Ichthyosis With Lamellar Scale",TERMINATED,,PHASE2,65.0,ACTUAL,Mayne Pharma International Pty Ltd,,3.0,,Futility,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,INDUSTRY,,,,,,,2021,0.0
NCT02124759,,2014-04-24,2020-08-10,,2021-09-15,2014-04-24,2014-04-28,ESTIMATED,2021-09-15,2021-10-15,ACTUAL,,,,2021-09-15,2021-10-15,ACTUAL,2014-04-02,ACTUAL,2014-04-02,2021-09,2021-09-30,2020-03-30,ACTUAL,2020-03-30,2018-02-23,ACTUAL,2018-02-23,,INTERVENTIONAL,MicroB1,Baseline participants were consented and passed screening and completed both high fat and low fat diet while randomized to one of the interventions.,Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1),Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1),COMPLETED,,PHASE2,20.0,ACTUAL,The University of Texas Health Science Center at San Antonio,"Despite continued recruitment efforts, we had difficulty with subjects fully completing the study due to dissatisfaction with the diets. Evaluable subjects completed both low and high fat diet while randomized to one of the three interventions, and only insulin sensitivity was captured for both the low fat and high fat diets due to the low completion numbers.",3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,OTHER,,,,,,,2020,1.0
NCT04251910,,2020-01-28,2023-08-01,,2023-08-28,2020-01-30,2020-02-05,ACTUAL,2023-08-28,2023-09-21,ACTUAL,,,,2023-08-28,2023-09-21,ACTUAL,2019-12-27,ACTUAL,2019-12-27,2023-08,2023-08-31,2022-01-24,ACTUAL,2022-01-24,2022-01-24,ACTUAL,2022-01-24,,INTERVENTIONAL,TRANQUILITY,The safety population consisted of all patients who received study drug.,Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia,"A Phase Ib/II, Multicenter, Randomized, Double Blind, Placebo Controlled, Ascending Dose Finding, Efficacy, Pharmacokinetic and Safety Study of BXCL501 In Agitation Associated With Dementia",COMPLETED,,PHASE1/PHASE2,100.0,ACTUAL,BioXcel Therapeutics Inc,,4.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 02:24:14.894168,2024-10-16 02:24:14.894168,INDUSTRY,,,,,,,2022,1.0
NCT02809131,,2016-04-27,2022-04-13,,2022-04-13,2016-06-21,2016-06-22,ESTIMATED,2022-04-13,2022-05-09,ACTUAL,,,,2022-04-13,2022-05-09,ACTUAL,2016-04-01,ACTUAL,2016-04-01,2022-04,2022-04-30,2021-09-30,ACTUAL,2021-09-30,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,ENVELOPE,,Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.,Randomized Noninferiority Study of an Antibacterial Envelope Alone Versus Envelope Plus Intraoperative Antibacterial Irrigant and Postoperative Antibiotics to Prevent Cardiac Implantable Electronic Device Infections in High-Risk Patients,COMPLETED,,PHASE3,1010.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 02:29:55.66105,2024-10-16 02:29:55.66105,OTHER,,,,,,,2021,0.0
NCT01675154,,2012-08-27,2021-05-21,,2021-07-26,2012-08-28,2012-08-29,ESTIMATED,2021-07-26,2021-08-19,ACTUAL,,,,2021-07-26,2021-08-19,ACTUAL,2015-11,ACTUAL,2015-11-30,2021-07,2021-07-31,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,The baseline characteristics are based on first intervention period assignment. This trial is an adaptive design/flexible design using responsive adaptive randomization. The participants were randomized from the start of the study,Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia,Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia,TERMINATED,,PHASE2,5.0,ACTUAL,University of Texas Southwestern Medical Center,"Only five patients were enrolled in the study. Two patients completed the study. One subject dropped our after Second Intervention Period. Participation of other two subjects was halted due to unavailability of study medications.~Study Design: Although protocol states This trial is randomized, double-blind cross-over trial, study design was actually not a cross over design, but adaptive/flexible design using a responsive adaptive randomization. Thus Arm/Group were not listed per sequence.",4.0,,Due to unavailability of the drug.,f,,,,t,,,,,,,,,,,,,2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,OTHER,,,,,,,2020,0.0
NCT01345136,,2011-04-21,,,2024-02-09,2011-04-28,2011-04-29,ESTIMATED,,,,,,,2024-02-09,2024-02-13,ACTUAL,2015-07-01,ACTUAL,2015-07-01,2024-02,2024-02-29,2024-02-06,ACTUAL,2024-02-06,2024-02-06,ACTUAL,2024-02-06,,INTERVENTIONAL,,,Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma,"A Single Arm, Monocenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Neurofibromatosis Type 2 - Related Vestibular Schwannoma",TERMINATED,,PHASE2,4.0,ACTUAL,Jonsson Comprehensive Cancer Center,,1.0,,slow accrual,f,,,,t,,,,,,,,,,,,,2024-10-16 02:29:55.66105,2024-10-16 02:29:55.66105,OTHER,,,,,,,2024,0.0
NCT01740297,,2012-11-14,2017-08-23,,2024-05-10,2012-11-30,2012-12-04,ESTIMATED,2017-10-06,2017-10-09,ACTUAL,,,,2024-05-10,2024-05-14,ACTUAL,2013-02-07,ACTUAL,2013-02-07,2024-05,2024-05-31,2021-03-09,ACTUAL,2021-03-09,2016-08-23,ACTUAL,2016-08-23,,INTERVENTIONAL,,All enrolled participants,Ipilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma,"Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects With Unresected, Stage IIIB-IV Melanoma",COMPLETED,,PHASE1/PHASE2,217.0,ACTUAL,Amgen,,3.0,,,f,,,,f,,,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-16 11:52:32.973311,2024-10-16 11:52:32.973311,INDUSTRY,,,,,,,2021,1.0
NCT04115098,,2019-10-02,2024-08-08,,2024-08-08,2019-10-02,2019-10-03,ACTUAL,2024-08-08,2024-09-04,ACTUAL,,,,2024-08-08,2024-09-04,ACTUAL,2020-06-25,ACTUAL,2020-06-25,2024-08,2024-08-31,2023-08-11,ACTUAL,2023-08-11,2023-08-11,ACTUAL,2023-08-11,,INTERVENTIONAL,,,Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials,Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials,TERMINATED,,PHASE2,42.0,ACTUAL,"The University of Texas Health Science Center, Houston",Terminated due to lack of recruitment,12.0,,lack of recruitment,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 01:37:17.045457,2024-10-15 01:37:17.045457,OTHER,,,,,,,2023,0.0
NCT04333290,,2020-03-18,,,2024-07-25,2020-04-02,2020-04-03,ACTUAL,,,,,,,2024-07-25,2024-07-26,ACTUAL,2024-07-15,ESTIMATED,2024-07-15,2024-07,2024-07-31,2024-07-25,ACTUAL,2024-07-25,2024-07-25,ACTUAL,2024-07-25,,INTERVENTIONAL,,,Study Evaluating the Safety of Myeliviz Myelin-Targeting PET Agent,Phase 1 Study Evaluating the Safety of [11C]MeDAS Myelin-Targeting PET Agent in Humans,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,The Cleveland Clinic,,1.0,,Unable to obtain Myeliviz for trial,f,,,,f,t,f,,,,,,,,,YES,data will be available per NIH policies,2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,OTHER,,,,,,,2024,0.0
NCT01721876,,2012-11-02,2021-09-09,2014-10-14,2023-02-06,2012-11-02,2012-11-06,ESTIMATED,2021-10-25,2021-11-19,ACTUAL,2014-11-19,2014-12-04,ESTIMATED,2023-02-06,2023-02-08,ACTUAL,2013-01-29,ACTUAL,2013-01-29,2023-02,2023-02-28,2021-05-28,ACTUAL,2021-05-28,2014-08-12,ACTUAL,2014-08-12,,INTERVENTIONAL,,The randomised set (RS) included all patients who had been randomised at the database snapshot.,"Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)","A Phase III Randomised, Double-blind, Controlled, Parallel Group Study of Intravenous Volasertib in Combination With Subcutaneous Low-dose Cytarabine vs. Placebo + Low-dose Cytarabine in Patients >=65 Years With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy",COMPLETED,,PHASE3,666.0,ACTUAL,Boehringer Ingelheim,The final analysis presented in this report was conducted after 574 Overall Survival events had occurred. The final analysis was exploratory and descriptive.,2.0,,,f,,,,,,,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datatransparency",2024-10-16 02:29:55.66105,2024-10-16 02:29:55.66105,INDUSTRY,,,,,,,2021,1.0
NCT03853317,,2019-02-14,2024-04-03,,2024-08-07,2019-02-22,2019-02-25,ACTUAL,2024-08-07,2024-08-09,ACTUAL,,,,2024-08-07,2024-08-09,ACTUAL,2020-02-19,ACTUAL,2020-02-19,2024-08,2024-08-31,2022-09-19,ACTUAL,2022-09-19,2021-09-29,ACTUAL,2021-09-29,,INTERVENTIONAL,,,"QUILT-3.063: A Study of N-803, haNK and Avelumab in Patients With Merkel Cell Carcinoma That Has Progressed After Checkpoint Therapy","QUILT-3.063: A Phase 2 Study of Combination Therapy With an IL-15 Superagonist (N-803), Off-the-shelf CD16-targeted Natural Killer Cells (haNK), and Avelumab Without Cytotoxic Chemotherapy in Subjects With Merkel Cell Carcinoma (MCC) That Has Progressed on or After Treatment With a Checkpoint Inhibitor.",TERMINATED,,PHASE2,9.0,ACTUAL,"ImmunityBio, Inc.",,1.0,,Not meeting recruitment goal,f,,,,f,t,f,,,,,,,,,,,2024-10-15 15:18:40.354512,2024-10-15 15:18:40.354512,INDUSTRY,,,,,,,2022,0.0
NCT03574753,,2018-04-18,2021-05-27,,2021-09-21,2018-06-20,2018-07-02,ACTUAL,2021-06-28,2021-06-29,ACTUAL,,,,2021-09-21,2021-10-18,ACTUAL,2018-03-16,ACTUAL,2018-03-16,2021-09,2021-09-30,2021-07-30,ACTUAL,2021-07-30,2019-12-21,ACTUAL,2019-12-21,,INTERVENTIONAL,,,Lung-MAP S1400K: c-MET Positive,A Phase II Study of ABBV-399 in Patients With C-Met Positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP SUB-STUDY),COMPLETED,,PHASE2,28.0,ACTUAL,SWOG Cancer Research Network,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 02:29:55.66105,2024-10-16 02:29:55.66105,NETWORK,,,,,,,2021,0.0
NCT04893915,,2021-05-14,,,2022-02-23,2021-05-14,2021-05-20,ACTUAL,,,,,,,2022-02-23,2022-03-11,ACTUAL,2022-06-30,ESTIMATED,2022-06-30,2022-02,2022-02-28,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Cytokine-induced Memory-like NK Cells in Relapsed/Refractory AML and MDS,A Phase 2 Study of Cytokine-induced Memory-like NK Cells in Relapsed/Refractory AML and MDS,WITHDRAWN,,PHASE2,0.0,ACTUAL,Washington University School of Medicine,,3.0,,No funding support,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 11:52:32.973311,2024-10-16 11:52:32.973311,OTHER,,,,,,,2024,0.0
NCT04607148,,2020-10-22,2023-09-19,,2023-10-12,2020-10-22,2020-10-29,ACTUAL,2023-10-12,2023-10-16,ACTUAL,,,,2023-10-12,2023-10-16,ACTUAL,2020-11-16,ACTUAL,2020-11-16,2023-10,2023-10-31,2022-11-14,ACTUAL,2022-11-14,2022-11-14,ACTUAL,2022-11-14,,INTERVENTIONAL,,,A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration,"A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration",TERMINATED,,PHASE2,144.0,ACTUAL,"Genentech, Inc.",,4.0,,The benefit to risk balance did not support further treatment with galegenimab (FHTR2163).,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 02:29:55.66105,2024-10-16 02:29:55.66105,INDUSTRY,,,,,,,2022,0.0
NCT05022394,,2020-04-22,,,2022-05-24,2021-08-24,2021-08-26,ACTUAL,,,,,,,2022-05-24,2022-05-27,ACTUAL,2021-02-18,ACTUAL,2021-02-18,2022-05,2022-05-31,2021-02-18,ACTUAL,2021-02-18,2021-02-18,ACTUAL,2021-02-18,,INTERVENTIONAL,,,"Sapanisertib and Nivolumab for the Treatment of Stage I-IV Non-small Cell Lung Cancer in Patients Who Have Progressed on Prior PD-1/PD-L1 Inhibitor Therapy, I-OVERCOME Study",Phase I/II Study to OVERCOME Resistance to PD-1/PD-L1 Inhibitor Immunotherapy in Advanced Non-Small Cell Lung Cancer - I-OVERCOME Trial,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,No participants Enrolled,f,,,,f,t,f,,,,,,,,,,,2024-10-16 02:29:55.66105,2024-10-16 02:29:55.66105,OTHER,,,,,,,2021,0.0
NCT04312282,,2020-03-13,,,2021-07-26,2020-03-16,2020-03-18,ACTUAL,,,,,,,2021-07-26,2021-07-28,ACTUAL,2020-03-06,ACTUAL,2020-03-06,2021-07,2021-07-31,2021-06-15,ACTUAL,2021-06-15,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,,,"The Effect of Tesetaxel on the QTc Interval and the Effect of Food, Itraconazole, and Rifampin on Tesetaxel Pharmacokinetics in Patients With Advanced Solid Tumors","An Open-Label Study of the Effect of Tesetaxel on the QTc Interval and the Effect of Food, Itraconazole, and Rifampin on Tesetaxel Pharmacokinetics in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1,93.0,ACTUAL,"Odonate Therapeutics, Inc.",,4.0,,The Sponsor has discontinued the development of tesetaxel,f,,,,f,t,f,,,,,,,,,,,2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,INDUSTRY,,,,,,,2021,0.0
NCT01759836,,2013-01-01,,,2022-01-09,2013-01-02,2013-01-03,ESTIMATED,,,,,,,2022-01-09,2022-01-25,ACTUAL,2012-10,,2012-10-31,2022-01,2022-01-31,2021-09-30,ACTUAL,2021-09-30,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,,,Impact of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer,"A Randomized Double Blind, Placebo-controlled Study Determining the Role of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer",COMPLETED,,PHASE2,364.0,ACTUAL,Asan Medical Center,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,OTHER,,,,,,,2021,0.0
NCT05609656,,2022-10-27,,,2024-05-31,2022-11-07,2022-11-08,ACTUAL,,,,,,,2024-05-31,2024-06-03,ACTUAL,2023-01-26,ACTUAL,2023-01-26,2024-05,2024-05-31,2024-05-02,ACTUAL,2024-05-02,2024-04-08,ACTUAL,2024-04-08,,INTERVENTIONAL,ELI,,Electroporation and Immunotherapy in Metastatic Colorectal Cancer,"Calcium Electroporation in Combination With Irreversible Electroporation and Immunotherapy in Patients With Proficient Mismatch Repair System (pMMR) Metastatic Colorectal Cancer - A Prospective, Phase 2 Study",TERMINATED,,PHASE2,4.0,ACTUAL,Zealand University Hospital,,1.0,,The study was terminated on the basis on an evaluation of the efficacy and safety of the 4 included and treated patients.,f,,,,f,f,f,,,t,,,,,,NO,,2024-10-16 11:52:32.973311,2024-10-16 11:52:32.973311,OTHER,,,,,,,2024,0.0
NCT04623684,,2020-10-31,,,2022-03-23,2020-11-04,2020-11-10,ACTUAL,,,,,,,2022-03-23,2022-04-04,ACTUAL,2020-03-24,ACTUAL,2020-03-24,2022-03,2022-03-31,2020-09-29,ACTUAL,2020-09-29,2020-09-22,ACTUAL,2020-09-22,,INTERVENTIONAL,,,Efficacy and Safety of Mydriatic Microdrops Compared With Standard Drops for Retinopathy of Prematurity (ROP) Screening: a Pilot Randomized Clinical Trial,Efficacy and Safety of Mydriatic Microdrops Compared With Standard Drops for Retinopathy of Prematurity (ROP) Screening: a Pilot Randomized Clinical Trial,COMPLETED,,PHASE4,25.0,ACTUAL,Aristotle University Of Thessaloniki,,2.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 02:29:55.66105,2024-10-16 02:29:55.66105,OTHER,,,,,,,2020,0.0
NCT03930615,,2019-04-26,2022-10-05,,2024-07-29,2019-04-26,2019-04-29,ACTUAL,2022-10-05,2022-11-01,ACTUAL,,,,2024-07-29,2024-08-22,ACTUAL,2019-06-21,ACTUAL,2019-06-21,2024-07,2024-07-31,2022-03-16,ACTUAL,2022-03-16,2021-10-27,ACTUAL,2021-10-27,,INTERVENTIONAL,,Treated participants,Extension of Letermovir (LET) From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Participants (MK-8228-040),"A Phase 3 Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Letermovir (LET) Prophylaxis When Extended From 100 Days to 200 Days Post-transplant in Cytomegalovirus (CMV) Seropositive Recipients (R+) of an Allogenic Hematopoietic Stem Cell Transplant (HSCT)",COMPLETED,,PHASE3,220.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 11:52:32.973311,2024-10-16 11:52:32.973311,INDUSTRY,,,,,,,2022,1.0
NCT04091360,,2019-06-20,2022-01-18,,2022-08-29,2019-09-13,2019-09-16,ACTUAL,2022-07-20,2022-07-25,ACTUAL,,,,2022-08-29,2022-09-21,ACTUAL,2019-04-29,ACTUAL,2019-04-29,2022-08,2022-08-31,2021-01-21,ACTUAL,2021-01-21,2020-12-10,ACTUAL,2020-12-10,,INTERVENTIONAL,,,A Study of RPL554 Drug Administered by Metered Dose Inhaler to Treat Chronic Obstructive Pulmonary Disease,"A Phase II, Randomised Study to Assess the Pharmacokinetics, Safety and Pharmacodynamics of Single and Repeat Doses of RPL554 Administered by Pressurised Metered Dose Inhaler in Patients With COPD",COMPLETED,,PHASE2,40.0,ACTUAL,Verona Pharma plc,,6.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 15:18:40.354512,2024-10-15 15:18:40.354512,INDUSTRY,,,,,,,2021,1.0
NCT05393635,,2022-05-23,,,2022-12-16,2022-05-23,2022-05-26,ACTUAL,,,,,,,2022-12-16,2022-12-20,ACTUAL,2022-08,ESTIMATED,2022-08-31,2022-12,2022-12-31,2022-12-08,ACTUAL,2022-12-08,2022-12-08,ACTUAL,2022-12-08,,INTERVENTIONAL,DELTA-2,,ITIL-168 in Advanced Solid Tumors,"A Phase 1, Open-Label, Multicenter Study Evaluating the Safety, Feasibility, and Preliminary Efficacy of ITIL-168 With Pembrolizumab in Subjects With Advanced Solid Tumors",WITHDRAWN,,PHASE1,0.0,ACTUAL,Instil Bio,,3.0,,business decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 11:52:32.973311,2024-10-16 11:52:32.973311,INDUSTRY,,,,,,,2022,0.0
NCT03324828,,2017-10-21,,,2020-08-07,2017-10-26,2017-10-30,ACTUAL,,,,,,,2020-08-07,2020-08-11,ACTUAL,2017-11-01,ACTUAL,2017-11-01,2020-08,2020-08-31,2020-05-29,ACTUAL,2020-05-29,2020-05-29,ACTUAL,2020-05-29,,INTERVENTIONAL,SONRISA,,Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown),Double-blind Randomized Clinical Trial to Compare Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown),TERMINATED,,PHASE4,170.0,ACTUAL,"Hospital San Carlos, Madrid",,4.0,,COVID-19,f,,,,f,f,f,,,,,,,,,,,2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,OTHER,,,,,,,2020,0.0
NCT02795520,,2016-05-06,,,2021-11-15,2016-06-06,2016-06-10,ESTIMATED,,,,,,,2021-11-15,2021-11-24,ACTUAL,2016-04,ACTUAL,2016-04-30,2021-11,2021-11-30,2021-09,ACTUAL,2021-09-30,2021-05,ACTUAL,2021-05-31,,INTERVENTIONAL,,,"Pharmacological Study of Intravenous OTS167 in Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Advanced Myelodysplastic Syndromes, Advanced Myeloproliferative Neoplastic Disorders, or Advanced Chronic Myelogenous Leukemia","Phase I/II and Pharmacological Study of Intravenous OTS167 in Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Advanced Myelodysplastic Syndromes, Advanced Myeloproliferative Neoplastic Disorders, or Advanced Chronic Myelogenous Leukemia",TERMINATED,,PHASE1/PHASE2,32.0,ACTUAL,"OncoTherapy Science, Inc.",,1.0,,slow patient accrual,f,,,,f,,,,,,,,,,,,,2024-10-16 23:25:43.156989,2024-10-16 23:25:43.156989,INDUSTRY,,,,,,,2021,0.0
NCT03951753,,2019-05-14,2022-06-08,,2022-06-08,2019-05-14,2019-05-15,ACTUAL,2022-06-08,2023-03-20,ACTUAL,,,,2022-06-08,2023-03-20,ACTUAL,2019-06-28,ACTUAL,2019-06-28,2022-06,2022-06-30,2021-04-08,ACTUAL,2021-04-08,2021-04-08,ACTUAL,2021-04-08,,INTERVENTIONAL,,All randomized participants who received at least one dose of study drug.,A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM),The Effect of Tirzepatide on α and β Cell Function and Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus,COMPLETED,,PHASE1,117.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,INDUSTRY,,,,,,,2021,1.0
NCT04015518,,2019-07-09,2022-07-01,2021-03-17,2022-07-01,2019-07-09,2019-07-11,ACTUAL,2022-07-01,2022-07-28,ACTUAL,2021-03-17,2021-03-19,ACTUAL,2022-07-01,2022-07-28,ACTUAL,2019-07-31,ACTUAL,2019-07-31,2022-06,2022-06-30,2021-07-28,ACTUAL,2021-07-28,2020-08-06,ACTUAL,2020-08-06,,INTERVENTIONAL,,Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.,A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis,"Multi-center, Double-blind, Randomised, Placebo-controlled, Phase IIb Dose-finding Study to Evaluate Safety and Efficacy of Different Subcutaneous Doses of BI 655130 in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP)",COMPLETED,,PHASE2,152.0,ACTUAL,Boehringer Ingelheim,,5.0,,,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-16 23:32:33.643731,2024-10-16 23:32:33.643731,INDUSTRY,,,,,,,2021,1.0
NCT03021395,,2017-01-12,,,2019-03-21,2017-01-12,2017-01-13,ESTIMATED,,,,,,,2019-03-21,2019-03-22,ACTUAL,2017-02-08,ACTUAL,2017-02-08,2019-03,2019-03-31,2022-12,ESTIMATED,2022-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Efficacy of Decitabine in Clearance of MRD,Efficacy of Decitabine in Clearance of MRD,SUSPENDED,,PHASE1/PHASE2,300.0,ESTIMATED,"Institute of Hematology & Blood Diseases Hospital, China",,2.0,,The previous data needs to be analyzed.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 02:29:55.66105,2024-10-16 02:29:55.66105,OTHER,,,,,,,2022,0.0
NCT03064126,,2017-01-13,2020-05-21,,2024-04-25,2017-02-23,2017-02-24,ACTUAL,2020-06-30,2020-07-15,ACTUAL,,,,2024-04-25,2024-04-30,ACTUAL,2017-03-02,ACTUAL,2017-03-02,2024-04,2024-04-30,2023-10-25,ACTUAL,2023-10-25,2019-11-18,ACTUAL,2019-11-18,,INTERVENTIONAL,RANGER II SFA,,RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty,RANGER II SFA: A 3:1 Randomized Trial Comparing the Boston Scientific RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty for the Treatment of Superficial Femoral Arteries (SFA) and Proximal Popliteal Arteries (PPA),COMPLETED,,PHASE3,440.0,ACTUAL,Boston Scientific Corporation,,2.0,,,f,,,,t,f,t,,,,,,,,,NO,,2024-10-16 11:52:32.973311,2024-10-16 11:52:32.973311,INDUSTRY,,,,,,,2023,1.0
NCT04569357,,2020-09-22,2023-06-01,,2024-02-14,2020-09-28,2020-09-29,ACTUAL,2024-02-14,2024-08-01,ACTUAL,,,,2024-02-14,2024-08-01,ACTUAL,2020-11-20,ACTUAL,2020-11-20,2021-11,2021-11-30,2022-02-18,ACTUAL,2022-02-18,2022-02-18,ACTUAL,2022-02-18,,INTERVENTIONAL,,,Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Attention Deficit/Hyperactivity Disorder in Children,Multicenter Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Attention Deficit/Hyperactivity Disorder in Children,COMPLETED,,PHASE3,363.0,ACTUAL,Materia Medica Holding,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 01:42:45.200039,2024-10-15 01:42:45.200039,INDUSTRY,,,,,,,2022,1.0
NCT04120116,,2019-09-30,2023-03-30,2021-10-04,2023-04-25,2019-10-08,2019-10-09,ACTUAL,2023-04-25,2023-04-27,ACTUAL,,2023-04-27,ACTUAL,2023-04-25,2023-04-27,ACTUAL,2019-10-04,ACTUAL,2019-10-04,2023-04,2023-04-30,2020-12-17,ACTUAL,2020-12-17,2020-10-06,ACTUAL,2020-10-06,,INTERVENTIONAL,,Full Analysis Set is defined as all randomized subjects who received at least one dose of study drug or placebo in the study ear per the randomized treatment schedule,FX-322 in Adults With Stable Sensorineural Hearing Loss,"A Phase 2a, Prospective, Randomized, Double-Blind, Placebo-Controlled, Single and Repeat-Dose, Multicenter, Exploratory Efficacy Study of FX-322 Administered by Intratympanic Injection in Adults With Stable Sensorineural Hearing Loss",COMPLETED,,PHASE2,95.0,ACTUAL,Frequency Therapeutics,,4.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 11:52:32.973311,2024-10-16 11:52:32.973311,INDUSTRY,,,,,,,2020,1.0
NCT06046482,,2023-09-14,,,2024-08-30,2023-09-14,2023-09-21,ACTUAL,,,,,,,2024-08-30,2024-09-04,ACTUAL,2023-11-28,ACTUAL,2023-11-28,2024-08,2024-08-31,2024-08-26,ACTUAL,2024-08-26,2024-08-26,ACTUAL,2024-08-26,,INTERVENTIONAL,,,Phase II Trial of Magrolimab and Cetuximab with Pembrolizumab or Docetaxel for Recurrent/metastatic Head Neck Squamous Cell Carcinoma,Phase II Trial of Magrolimab and Cetuximab with Pembrolizumab or Docetaxel for Recurrent/metastatic Head Neck Squamous Cell Carcinoma,TERMINATED,,PHASE2,4.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,Slow Accrual,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 01:42:45.200039,2024-10-15 01:42:45.200039,OTHER,,,,,,,2024,0.0
NCT04150107,,2019-10-31,2021-11-14,,2022-05-07,2019-10-31,2019-11-04,ACTUAL,2022-05-07,2022-06-02,ACTUAL,,,,2022-05-07,2022-06-02,ACTUAL,2019-10-17,ACTUAL,2019-10-17,2022-05,2022-05-31,2020-03-12,ACTUAL,2020-03-12,2020-02-06,ACTUAL,2020-02-06,,INTERVENTIONAL,,"All patients are first administered a placebo, or is the standard of care.",A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 Diabetes,"A Phase 2 Randomized, Open Label Crossover Study to Compare ORMD-0801 Given Once Daily at Bedtime to ORMD-0801 Given Three Times Daily (45-90 Minutes Before Meals) in Subjects With Type 1 Diabetes",COMPLETED,,PHASE2,30.0,ACTUAL,"Oramed, Ltd.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 11:52:32.973311,2024-10-16 11:52:32.973311,INDUSTRY,,,,,,,2020,1.0
NCT03588936,,2018-07-04,,,2021-10-04,2018-07-16,2018-07-17,ACTUAL,,,,,,,2021-10-04,2021-10-11,ACTUAL,2018-09-14,ACTUAL,2018-09-14,2021-10,2021-10-31,2020-07-15,ACTUAL,2020-07-15,2020-07-15,ACTUAL,2020-07-15,,INTERVENTIONAL,,,Nivolumab and Tocilizumab for Relapsed Hematological Malignancy Post-allogeneic Transplant,Phase 1 Study of Nivolumab in Combination With Tocilizumab for Treatment of Patients With Relapsed Hematological Malignancies Post-allogeneic Transplant,TERMINATED,,PHASE1,2.0,ACTUAL,Medical College of Wisconsin,,2.0,,Poor accrual and loss of funding.,,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 01:42:45.200039,2024-10-15 01:42:45.200039,OTHER,,,,,,,2020,0.0
NCT05143489,,2021-11-05,,,2024-04-18,2021-11-22,2021-12-03,ACTUAL,,,,,,,2024-04-18,2024-04-22,ACTUAL,2022-01-03,ACTUAL,2022-01-03,2024-04,2024-04-30,2024-04-17,ACTUAL,2024-04-17,2024-04-17,ACTUAL,2024-04-17,,INTERVENTIONAL,,,The Effect of Pretreatment With Intravenous Lidocaine for Intravenous Contrast:,"The Effect of Pretreatment With Intravenous Lidocaine for Intravenous Contrast: A Double-blinded, Randomized-control Trial",TERMINATED,,PHASE4,3.0,ACTUAL,Maimonides Medical Center,,2.0,,1. CTs occur late at night and weekends when their is no availability of the research staff.~. No activity since a year+,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 11:52:32.973311,2024-10-16 11:52:32.973311,OTHER,,,,,,,2024,0.0
NCT03975101,,2019-05-31,,,2020-10-13,2019-06-03,2019-06-05,ACTUAL,,,,,,,2020-10-13,2020-10-19,ACTUAL,2019-07-05,ACTUAL,2019-07-05,2020-05,2020-05-31,2020-06-15,ESTIMATED,2020-06-15,2020-05-25,ESTIMATED,2020-05-25,,INTERVENTIONAL,,,Very Small Embryonic-like Stem Cells for Knee Osteoarthritis,Autologous Very Small Embryonic-like Stem Cells(VSELs) for Knee Osteoarthritis,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Fuda Cancer Hospital, Guangzhou",,4.0,,Policy changes have contributed to the failure to carry out smoothly,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 02:29:55.66105,2024-10-16 02:29:55.66105,OTHER,,,,,,,2020,0.0
NCT06067191,,2023-09-27,,,2023-10-05,2023-09-27,2023-10-04,ACTUAL,,,,,,,2023-10-05,2023-10-10,ACTUAL,2022-08-08,ACTUAL,2022-08-08,2023-10,2023-10-31,2022-12-02,ACTUAL,2022-12-02,2022-12-02,ACTUAL,2022-12-02,,INTERVENTIONAL,,,"Safety, Pharmacokinetics,and Antiviral Activity of RV299 Against Respiratory Syncytical Virus (RSV)","A RANDOMISED, PHASE 1B, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND ANTIVIRAL ACTIVITY OF RV299 AGAINST RESPIRATORY SYNCYTIAL VIRUS IN THE VIRAL CHALLENGE MODEL",COMPLETED,,PHASE1,82.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 11:52:32.973311,2024-10-16 11:52:32.973311,INDUSTRY,,,,,,,2022,1.0
NCT04032704,,2019-07-23,,,2024-04-15,2019-07-23,2019-07-25,ACTUAL,,,,,,,2024-04-15,2024-04-17,ACTUAL,2019-10-09,ACTUAL,2019-10-09,2024-04,2024-04-30,2023-11-28,ACTUAL,2023-11-28,2023-11-28,ACTUAL,2023-11-28,,INTERVENTIONAL,,,A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors,Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors,TERMINATED,,PHASE2,205.0,ACTUAL,Seagen Inc.,,5.0,,Study closed due to portfolio prioritization,t,,,,f,t,f,,,,,,,,,,,2024-10-16 02:29:55.66105,2024-10-16 02:29:55.66105,INDUSTRY,,NCT06362590,AVAILABLE,,,,2023,0.0
NCT03574857,,2018-04-16,,,2021-02-10,2018-06-20,2018-07-02,ACTUAL,,,,,,,2021-02-10,2021-02-16,ACTUAL,2018-06-01,ACTUAL,2018-06-01,2021-02,2021-02-28,2021-01-01,ACTUAL,2021-01-01,2021-01-01,ACTUAL,2021-01-01,,INTERVENTIONAL,,,Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance,Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance,TERMINATED,,PHASE4,5.0,ACTUAL,University of Virginia,,2.0,,Low enrollment,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 02:29:55.66105,2024-10-16 02:29:55.66105,OTHER,,,,,,,2021,0.0
NCT04667377,,2020-12-08,2023-10-06,2023-08-02,2023-10-06,2020-12-08,2020-12-14,ACTUAL,2023-10-06,2023-11-02,ACTUAL,,2023-08-03,ACTUAL,2023-10-06,2023-11-02,ACTUAL,2021-03-08,ACTUAL,2021-03-08,2023-10,2023-10-31,2022-10-07,ACTUAL,2022-10-07,2022-09-15,ACTUAL,2022-09-15,,INTERVENTIONAL,,"Full analysis set (FAS): All randomised participants who received at least one dose of trial medication and who had analysable data for at least one efficacy endpoint, using planned maintenance treatment.",A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight,"A Phase II, Randomized, Double Blind, Parallel Group,46 Weeks Dose-finding Study of BI 456906 Administered Once Weekly Subcutaneously Compared With Placebo in Patients With Obesity or Overweight",COMPLETED,,PHASE2,387.0,ACTUAL,Boehringer Ingelheim,,5.0,,,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-16 02:29:55.66105,2024-10-16 02:29:55.66105,INDUSTRY,,,,,,,2022,1.0
NCT03422679,,2018-01-19,2023-10-23,,2024-01-12,2018-01-30,2018-02-06,ACTUAL,2024-01-12,2024-01-16,ACTUAL,,,,2024-01-12,2024-01-16,ACTUAL,2017-12-05,ACTUAL,2017-12-05,2024-01,2024-01-31,2022-11-11,ACTUAL,2022-11-11,2022-11-11,ACTUAL,2022-11-11,,INTERVENTIONAL,,,Study of CB-103 in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies,"A Phase I/IIA, Multi-Centre, Open-Label, Dose-Escalation Study With Expansion Arms to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CB-103 Administered Orally in Adult Patients With Locally Advanced or Metastatic Solid Tumours and Haematological Malignancies Characterised by Alterations of the NOTCH Signalling Pathway",TERMINATED,,PHASE1/PHASE2,79.0,ACTUAL,Cellestia Biotech AG,,1.0,,business reason,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 02:29:55.66105,2024-10-16 02:29:55.66105,INDUSTRY,,,,,,,2022,0.0
NCT03871829,,2019-03-11,2023-10-12,,2023-11-29,2019-03-11,2019-03-12,ACTUAL,2023-11-29,2023-12-19,ACTUAL,,,,2023-11-29,2023-12-19,ACTUAL,2019-05-31,ACTUAL,2019-05-31,2023-11,2023-11-30,2023-01-10,ACTUAL,2023-01-10,2022-10-24,ACTUAL,2022-10-24,,INTERVENTIONAL,,,Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab,A Phase 2 Study of Daratumumab Subcutaneous (Dara-SC) Administration in Combination With Carfilzomib and Dexamethasone (DKd) Compared With Carfilzomib and Dexamethasone (Kd) in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab to Evaluate Daratumumab Retreatment,TERMINATED,,PHASE2,88.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,The decision was made to discontinue the 54767414MMY2065 study as the Data Review Committee recommendation was early stop of the study for futility.,f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 23:32:33.643731,2024-10-16 23:32:33.643731,INDUSTRY,,,,,,,2023,0.0
NCT02686658,,2016-02-16,2023-01-27,2020-09-30,2024-02-20,2016-02-18,2016-02-19,ESTIMATED,2023-04-18,2023-05-11,ACTUAL,2020-10-07,2020-10-19,ACTUAL,2024-02-20,2024-02-23,ACTUAL,2016-01-20,ACTUAL,2016-01-20,2023-04,2023-04-30,2020-04-23,ACTUAL,2020-04-23,2019-09-26,ACTUAL,2019-09-26,,INTERVENTIONAL,,,Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration,"A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration",COMPLETED,,PHASE2/PHASE3,286.0,ACTUAL,Astellas Pharma Inc,,6.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 23:32:33.643731,2024-10-16 23:32:33.643731,INDUSTRY,,,,,,,2020,1.0
NCT03515629,,2018-04-23,2022-07-28,,2022-10-22,2018-04-23,2018-05-03,ACTUAL,2022-10-22,2022-11-16,ACTUAL,,,,2022-10-22,2022-11-16,ACTUAL,2018-07-02,ACTUAL,2018-07-02,2022-10,2022-10-31,2021-07-29,ACTUAL,2021-07-29,2021-07-29,ACTUAL,2021-07-29,,INTERVENTIONAL,,"Safety analysis set (SAF), defined as all enrolled participants who received any amount of study treatment.","REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in Patients With Lung Cancer","A Randomized, Phase 3, Open-Label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 ≥50%",TERMINATED,,PHASE3,5.0,ACTUAL,Regeneron Pharmaceuticals,,3.0,,Business decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 23:32:33.643731,2024-10-16 23:32:33.643731,INDUSTRY,,,,,,,2021,0.0
NCT03721211,,2018-10-24,,,2020-02-28,2018-10-24,2018-10-26,ACTUAL,,,,,,,2020-02-28,2020-03-03,ACTUAL,2020-02-01,ESTIMATED,2020-02-01,2020-02,2020-02-29,2024-10-31,ESTIMATED,2024-10-31,2020-02-28,ACTUAL,2020-02-28,,INTERVENTIONAL,,,Imaging With [11C]Martinostat in Breast Cancer,Imaging With [11C]Martinostat in Breast Cancer,WITHDRAWN,,PHASE1,0.0,ACTUAL,Massachusetts General Hospital,,1.0,,Principal investigator left the study institution.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:32:33.643731,2024-10-16 23:32:33.643731,OTHER,,,,,,,2024,0.0
NCT04985825,,2021-07-20,,,2022-09-12,2021-07-30,2021-08-02,ACTUAL,,,,,,,2022-09-12,2022-09-13,ACTUAL,2021-12-16,ACTUAL,2021-12-16,2022-09,2022-09-30,2022-08-17,ACTUAL,2022-08-17,2022-08-17,ACTUAL,2022-08-17,,INTERVENTIONAL,I-PACE,,Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma,Phase 2 Study of Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma (I-PACE),WITHDRAWN,,PHASE2,0.0,ACTUAL,Centessa Pharmaceuticals plc,,1.0,,Business decision,,,,,f,t,f,,,,,,,,,NO,,2024-10-16 11:58:31.365754,2024-10-16 11:58:31.365754,INDUSTRY,,,,,,,2022,0.0
NCT05007041,,2021-08-09,2024-03-01,,2024-06-28,2021-08-09,2021-08-16,ACTUAL,2024-04-04,2024-05-01,ACTUAL,,,,2024-06-28,2024-07-11,ACTUAL,2021-09-21,ACTUAL,2021-09-21,2024-06,2024-06-30,2023-06-08,ACTUAL,2023-06-08,2023-03-04,ACTUAL,2023-03-04,,INTERVENTIONAL,,,Simultaneous RZV and aIIV4 Vaccination,Safety of Simultaneous Vaccination With Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Inactivated Influenza Vaccine (aIIV4),COMPLETED,,PHASE4,267.0,ACTUAL,Duke University,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 23:32:33.643731,2024-10-16 23:32:33.643731,OTHER,,,,,,,2023,1.0
NCT03901573,,2019-03-26,,,2024-02-20,2019-04-01,2019-04-03,ACTUAL,,,,,,,2024-02-20,2024-02-22,ACTUAL,2019-12-26,ACTUAL,2019-12-26,2024-02,2024-02-29,2023-08-15,ACTUAL,2023-08-15,2023-08-15,ACTUAL,2023-08-15,,INTERVENTIONAL,,,High-Risk Skin Cancers With Atezolizumab Plus NT-I7,"A Phase 1b/2a, Open Label Study to Evaluate Anti-tumor Efficacy and Safety of rhIL-7-hyFc (NT-I7) in Combination With Anti-PD-L1 (Atezolizumab) in Patients With Anti-PD-1/PD-L1 naïve or Relapsed/Refractory High-risk Skin Cancers",TERMINATED,,PHASE1/PHASE2,31.0,ACTUAL,NeoImmuneTech,,2.0,,Strategic decision by sponsor,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:29:55.66105,2024-10-16 02:29:55.66105,INDUSTRY,,,,,,,2023,0.0
NCT02978885,,2016-11-28,2021-08-17,,2021-08-17,2016-11-29,2016-12-01,ESTIMATED,2021-08-17,2021-09-14,ACTUAL,,,,2021-08-17,2021-09-14,ACTUAL,2018-06-11,ACTUAL,2018-06-11,2021-08,2021-08-31,2020-02-05,ACTUAL,2020-02-05,2020-02-05,ACTUAL,2020-02-05,,INTERVENTIONAL,,Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Study terminated due to poor enrollment.,Imaging of Peri-operative (periOP) Lung Injury,In Vivo Imaging of Peri-operative (periOP) Destructive Processes in the Lung,TERMINATED,,PHASE2,1.0,ACTUAL,Columbia University,Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).,2.0,,Poor enrollment,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 23:32:33.643731,2024-10-16 23:32:33.643731,OTHER,,,,,,,2020,0.0
NCT02424851,,2015-03-10,2021-05-11,,2022-01-26,2015-04-22,2015-04-23,ESTIMATED,2022-01-26,2022-01-27,ACTUAL,,,,2022-01-26,2022-01-27,ACTUAL,2014-11,,2014-11-30,2022-01,2022-01-31,2020-04-20,ACTUAL,2020-04-20,2020-04-20,ACTUAL,2020-04-20,,INTERVENTIONAL,OPTIMAL,,Optimising Renal Outcome in Myeloma Renal Failure,"A Study of Thalidomide, Bendamustine and Dexamethasone (BTD) Versus Bortezomib, Bendamustine and Dexamethasone (BBD) in Patients With Renal Failure Defined as a GFR Below 30 Mls/Min",COMPLETED,,PHASE2,31.0,ACTUAL,Oxford University Hospitals NHS Trust,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 11:58:31.365754,2024-10-16 11:58:31.365754,OTHER,,,,,,,2020,1.0
NCT02631070,,2015-11-10,2020-05-01,2018-05-16,2021-11-19,2015-12-11,2015-12-15,ESTIMATED,2020-05-01,2020-05-22,ACTUAL,2018-05-16,2018-05-18,ACTUAL,2021-11-19,2021-12-17,ACTUAL,2016-02-09,ACTUAL,2016-02-09,2021-11,2021-11-30,2020-11-26,ACTUAL,2020-11-26,2019-06-18,ACTUAL,2019-06-18,,INTERVENTIONAL,MEDALIST,,"A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes","A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo for the Treatment of Anemia Due to the IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions.",COMPLETED,,PHASE3,229.0,ACTUAL,Celgene,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 23:32:33.643731,2024-10-16 23:32:33.643731,INDUSTRY,,,,,,,2020,1.0
NCT03818776,,2019-01-18,,,2024-02-14,2019-01-25,2019-01-28,ACTUAL,,,,,,,2024-02-14,2024-02-15,ACTUAL,2019-08-30,ACTUAL,2019-08-30,2024-02,2024-02-29,2022-01-27,ACTUAL,2022-01-27,2022-01-27,ACTUAL,2022-01-27,,INTERVENTIONAL,,,Proton Based Cardiac Sparing Accelerated Fractionated RadioTherapy in Unresectable NSCLC,A Pilot Trial of Proton Based Cardiac Sparing Accelerated Fractionated RadioTherapy in Unresectable Non-Small Cell Lung Cancer With Extended Durvalumab Therapy (PARTICLE-D),TERMINATED,,EARLY_PHASE1,7.0,ACTUAL,Case Comprehensive Cancer Center,,2.0,,Safety,f,,,,t,t,t,,,,,,Beginning 3 months and ending 5 years following article publication,"Will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. To gain access, data requesters will need to sign a data access agreement",,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)",2024-10-16 23:32:33.643731,2024-10-16 23:32:33.643731,OTHER,,,,,,,2022,0.0
NCT04190056,,2019-12-04,2023-07-19,,2023-08-09,2019-12-04,2019-12-09,ACTUAL,2023-08-09,2023-08-31,ACTUAL,,,,2023-08-09,2023-08-31,ACTUAL,2021-03-11,ACTUAL,2021-03-11,2023-08,2023-08-31,2023-06-15,ACTUAL,2023-06-15,2023-06-15,ACTUAL,2023-06-15,,INTERVENTIONAL,,"The study closed early due to a change in practice patterns, and no participants were enrolled on arm A",Pembrolizumab and Tamoxifen With or Without Vorinostat for the Treatment of Estrogen Receptor Positive Breast Cancer,Epigenetic Priming for Immune Therapy in ER-Positive Breast Cancer in Biomarker Select Population,TERMINATED,,PHASE2,1.0,ACTUAL,"University of California, San Francisco",The study closed early due to change in practice patterns,2.0,,Change in practice patterns,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 11:58:31.365754,2024-10-16 11:58:31.365754,OTHER,,,,,,,2023,0.0
NCT04629534,,2020-11-10,2022-06-01,,2023-02-17,2020-11-10,2020-11-16,ACTUAL,2023-02-17,2023-03-15,ACTUAL,,,,2023-02-17,2023-03-15,ACTUAL,2021-05-06,ACTUAL,2021-05-06,2023-02,2023-02-28,2022-04-01,ACTUAL,2022-04-01,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,MoMO PIP,Mother/Infant Dyads that delivered at the Medical University of South Carolina between 24-34 weeks gestation were eligible for enrollment. Mother's and infants are counted separately in these results as 1 mother continued the study after her child was removed for parental preferences.,Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP) Pilot Study,"Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP): Maternal Diet and Vitamin D Supplementation Effects on Preterm Infants, a Randomized Control Pilot Study.",TERMINATED,,PHASE4,8.0,ACTUAL,Medical University of South Carolina,Early termination leading to a small number of subjects analyzed with difficulty in enrollment. Technical issue with calculating total vitamin D intake through formula fortification and TPN along with the study drugs which can skew our data.,2.0,,"low enrollment, lack of funding",f,,,,,t,f,,,,,,,,,NO,,2024-10-16 11:58:31.365754,2024-10-16 11:58:31.365754,OTHER,,,,,,,2022,0.0
NCT03818542,,2019-01-24,,,2020-12-30,2019-01-24,2019-01-28,ACTUAL,,,,,,,2020-12-30,2020-12-31,ACTUAL,2020-01-22,ACTUAL,2020-01-22,2020-12,2020-12-31,2020-09-23,ACTUAL,2020-09-23,2020-09-23,ACTUAL,2020-09-23,,INTERVENTIONAL,,,A Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma,A Phase 1b Multi-Center Pharmacodynamic Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma,TERMINATED,,PHASE1,3.0,ACTUAL,AbbVie,,4.0,,Strategic considerations,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 11:58:31.365754,2024-10-16 11:58:31.365754,INDUSTRY,,,,,,,2020,0.0
NCT04490018,,2020-07-27,2023-05-09,,2023-09-26,2020-07-27,2020-07-28,ACTUAL,2023-05-09,2023-06-06,ACTUAL,,,,2023-09-26,2023-10-03,ACTUAL,2021-03-16,ACTUAL,2021-03-16,2023-09,2023-09-30,2022-05-11,ACTUAL,2022-05-11,2022-05-11,ACTUAL,2022-05-11,,INTERVENTIONAL,,Analysis was performed on all randomized participants.,"Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents","Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix®, and When Administered Alone or Concomitantly With 9vHPV and Tdap-IPV Vaccines in Healthy Adolescents",COMPLETED,,PHASE3,463.0,ACTUAL,Sanofi,,3.0,,,f,,,,f,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 23:32:33.643731,2024-10-16 23:32:33.643731,INDUSTRY,,,,,,,2022,1.0
NCT03611582,,2018-07-17,2021-06-16,2021-03-03,2021-11-10,2018-08-01,2018-08-02,ACTUAL,2021-06-16,2021-07-09,ACTUAL,2021-03-03,2021-03-08,ACTUAL,2021-11-10,2021-11-11,ACTUAL,2018-08-01,ACTUAL,2018-08-01,2021-11,2021-11-30,2020-04-28,ACTUAL,2020-04-28,2020-03-18,ACTUAL,2020-03-18,,INTERVENTIONAL,STEP 3,Full analysis set (FAS) included all randomised participants.,Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program,Effect and Safety of Semaglutide 2.4 mg Once-weekly as Adjunct to Intensive Behavioural Therapy in Subjects With Overweight or Obesity,COMPLETED,,PHASE3,611.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 23:32:33.643731,2024-10-16 23:32:33.643731,INDUSTRY,,,,,,,2020,1.0
NCT02716675,,2016-03-17,2021-11-23,,2022-02-08,2016-03-22,2016-03-23,ESTIMATED,2022-01-12,2022-02-08,ACTUAL,,,,2022-02-08,2022-02-23,ACTUAL,2016-04-06,ACTUAL,2016-04-06,2022-02,2022-02-28,2020-12-01,ACTUAL,2020-12-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,,Safety Population,Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men,A Phase 2b Study to Evaluate the Safety and Efficacy of VRC01 Broadly Neutralizing Monoclonal Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men,COMPLETED,,PHASE2,2699.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 02:29:55.66105,2024-10-16 02:29:55.66105,NIH,,,,,,,2020,1.0
NCT04907227,,2021-05-26,2023-07-12,,2024-06-17,2021-05-26,2021-05-28,ACTUAL,2023-07-12,2023-08-04,ACTUAL,,,,2024-06-17,2024-07-12,ACTUAL,2020-09-23,ACTUAL,2020-09-23,2024-06,2024-06-30,2023-07-18,ACTUAL,2023-07-18,2022-08-03,ACTUAL,2022-08-03,,INTERVENTIONAL,,The baseline analysis population consisted of all randomized participants.,Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)-China Extension,"A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)",TERMINATED,,PHASE3,81.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,The data did not support study endpoints,f,,,,t,t,f,,,t,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 23:32:33.643731,2024-10-16 23:32:33.643731,INDUSTRY,,,,,,,2023,0.0
NCT03422536,,2018-01-19,2023-04-06,,2024-08-15,2018-02-02,2018-02-05,ACTUAL,2023-07-17,2023-07-19,ACTUAL,,,,2024-08-15,2024-09-04,ACTUAL,2017-12-05,ACTUAL,2017-12-05,2024-08,2024-08-31,2022-04-05,ACTUAL,2022-04-05,2022-03-29,ACTUAL,2022-03-29,,INTERVENTIONAL,,,"Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma","A Randomized, Phase II Study of Ficlatuzumab With or Without Cetuximab in Patients With Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma",COMPLETED,,PHASE2,78.0,ACTUAL,University of Arizona,,2.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 01:42:45.200039,2024-10-15 01:42:45.200039,OTHER,,,,,,,2022,1.0
NCT04501796,,2020-07-27,,,2023-07-13,2020-08-05,2020-08-06,ACTUAL,,,,,,,2023-07-13,2023-07-14,ACTUAL,2020-11-27,ACTUAL,2020-11-27,2023-07,2023-07-31,2023-02-23,ACTUAL,2023-02-23,2021-07-21,ACTUAL,2021-07-21,,INTERVENTIONAL,,,A Trial of NT-I7 in COVID-19 (SPESELPIS),"A Double-blind, Randomized, Placebo-controlled, Phase 1, Single-dose, Dose-escalating Trial of Long-acting Recombinant Human IL-7 (NT-I7) for COVID-19",TERMINATED,,PHASE1,7.0,ACTUAL,NeoImmuneTech,,2.0,,Study was halted due to lack of patient population resulting in slow enrollment.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 01:42:45.200039,2024-10-15 01:42:45.200039,INDUSTRY,,,,,,,2023,0.0
NCT04294836,,2020-03-02,,,2022-12-05,2020-03-02,2020-03-04,ACTUAL,,,,,,,2022-12-05,2022-12-07,ACTUAL,2021-12-01,ESTIMATED,2021-12-01,2020-06,2020-06-30,2023-12-31,ESTIMATED,2023-12-31,2023-01-31,ESTIMATED,2023-01-31,,INTERVENTIONAL,,,Curcumin in Advanced Cervical Cancer,Randomized Phase II Clinical Trial of Oral Turmeric Supplementation in Patients With Advanced Cervical Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Instituto Nacional de Cancerologia, Columbia",,2.0,,Issues with local regulatory authority,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 01:42:45.200039,2024-10-15 01:42:45.200039,OTHER_GOV,,,,,,,2023,0.0
NCT03970200,,2019-04-17,2023-10-02,2022-10-31,2023-10-27,2019-05-29,2019-05-31,ACTUAL,2023-10-27,2023-10-30,ACTUAL,,2023-10-30,ACTUAL,2023-10-27,2023-10-30,ACTUAL,2020-01-16,ACTUAL,2020-01-16,2023-10,2023-10-31,2022-05-14,ACTUAL,2022-05-14,2021-11-21,ACTUAL,2021-11-21,,INTERVENTIONAL,,,Penn Microbiome Therapy (PMT) for Severe-Clostridium Difficile Infection (CDI),"A Phase II, Randomized Trial to Evaluate the Safety and Efficacy of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products for Severe or Severe-Complicated/Fulminant Clostridium Difficile Infection",TERMINATED,,PHASE2,15.0,ACTUAL,University of Pennsylvania,,3.0,,Administrative reasons.,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:32:33.643731,2024-10-16 23:32:33.643731,OTHER,,,,,,,2022,0.0
NCT03403621,,2017-12-14,2023-10-27,,2023-11-20,2018-01-10,2018-01-18,ACTUAL,2023-11-20,2023-11-22,ACTUAL,,,,2023-11-20,2023-11-22,ACTUAL,2018-03-05,ACTUAL,2018-03-05,2023-11,2023-11-30,2020-02-26,ACTUAL,2020-02-26,2020-02-26,ACTUAL,2020-02-26,,INTERVENTIONAL,,,Hypertrophic Scar Prevention by Novel Topical Gel Application,"Double Blind, Single-Center, Randomized, Within Subject Placebo, Phase I Study Evaluating the Effects of Novel Topical Gel in Prevention of Hypertrophic Scar Formation",TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,Mayo Clinic,Terminated study due to funding changes.,2.0,,Funding changes.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,OTHER,,,,,,,2020,0.0
NCT03871959,,2019-03-08,,,2023-02-16,2019-03-11,2019-03-12,ACTUAL,,,,,,,2023-02-16,2023-02-17,ACTUAL,2019-09-15,ACTUAL,2019-09-15,2023-02,2023-02-28,2022-06-08,ACTUAL,2022-06-08,2022-05-30,ACTUAL,2022-05-30,,INTERVENTIONAL,CATRIPCA,,Pembrolizumab In Combination With Debio 1143 In Pancreatic and Colorectal Advanced/Metastatic Adenocarcinoma,CATRIPCA - A Phase I Study of PD1 Monoclonal Antibody (Pembrolizumab) In Combination With a IAP Antagonist (Debio 1143) In (Exocrine) Pancreatic And Colorectal Non MSI-high Advanced/Metastatic Adenocarcinoma.,COMPLETED,,PHASE1,54.0,ACTUAL,Centre Leon Berard,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,OTHER,,,,,,,2022,1.0
NCT02943785,,2016-10-21,2022-02-18,,2022-03-22,2016-10-21,2016-10-25,ESTIMATED,2022-03-22,2022-03-24,ACTUAL,,,,2022-03-22,2022-03-24,ACTUAL,2017-03-21,ACTUAL,2017-03-21,2022-03,2022-03-31,2021-02-28,ACTUAL,2021-02-28,2021-02-28,ACTUAL,2021-02-28,,INTERVENTIONAL,,Patient demographics were assessed in the Intent-to-Treat Analysis Set.,Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF),Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation (TAVI) - in Atrial Fibrillation,COMPLETED,,PHASE3,1426.0,ACTUAL,Daiichi Sankyo,,2.0,,,f,,,,t,t,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,INDUSTRY,,,,,,,2021,1.0
NCT05177328,,2021-12-15,,,2024-01-05,2021-12-15,2022-01-04,ACTUAL,,,,,,,2024-01-05,2024-01-09,ACTUAL,2022-07-18,ACTUAL,2022-07-18,2024-01,2024-01-31,2023-10-13,ACTUAL,2023-10-13,2023-10-13,ACTUAL,2023-10-13,,INTERVENTIONAL,TIME-1,,Targeted Investigation of Microbiome Elimination,A Pilot Study to Evaluate the Survival of Transplanted Staphylococcus Hominis A9 on the Skin of Adults With Moderate-to-Severe Atopic Dermatitis (ADRN-UCSD-001),TERMINATED,,PHASE1,17.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,Decision to terminate enrollment early was made by the protocol chair and NIAID,f,,,,t,t,f,,,,,,,,,,,2024-10-16 11:58:31.365754,2024-10-16 11:58:31.365754,NIH,,,,,,,2023,0.0
NCT03125187,,2017-03-29,,,2019-10-11,2017-04-18,2017-04-24,ACTUAL,,,,,,,2019-10-11,2019-10-15,ACTUAL,2021-02-20,ESTIMATED,2021-02-20,2019-03,2019-03-31,2022-11-10,ESTIMATED,2022-11-10,2021-02-20,ESTIMATED,2021-02-20,,INTERVENTIONAL,,,Study With Heparin Sodium in Intravenous Administration,Phase I Study With Pharmacodynamic Determination of Unfractionated Heparin of Porcine Origin of the Company União Química of Intravenous Use in Healthy Participants,SUSPENDED,,PHASE1,24.0,ESTIMATED,União Química Farmacêutica Nacional S/A,,2.0,,Delay in the R\&D stage,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,INDUSTRY,,,,,,,2022,0.0
NCT02826577,,2016-07-01,2023-04-13,,2024-05-06,2016-07-05,2016-07-11,ESTIMATED,2024-05-06,2024-05-16,ACTUAL,,,,2024-05-06,2024-05-16,ACTUAL,2017-05-01,ACTUAL,2017-05-01,2024-05,2024-05-31,2022-12-21,ACTUAL,2022-12-21,2021-12-21,ACTUAL,2021-12-21,,INTERVENTIONAL,,No data was collected or analyzed,Effects of Pregnenolone on Perceived Social Isolation,Effects of Pregnenolone on Perceived Social Isolation: A Double-blind Randomized Electrical Neuroimaging Study,TERMINATED,,PHASE2,34.0,ACTUAL,University of Chicago,,4.0,,Principal Investigator left institution.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,OTHER,,,,,,,2022,0.0
NCT04542434,,2020-09-04,,,2022-02-04,2020-09-06,2020-09-09,ACTUAL,,,,,,,2022-02-04,2022-02-21,ACTUAL,2022-01-20,ACTUAL,2022-01-20,2021-12,2021-12-31,2022-01-20,ACTUAL,2022-01-20,2022-01-20,ACTUAL,2022-01-20,,INTERVENTIONAL,,,Niclosamide in COVID-19,"A Phase 2 Randomized Double Blind, Placebo-controlled Study on the Safety and Efficacy of Niclosamide in Patients With COVID-19",WITHDRAWN,,PHASE2,0.0,ACTUAL,Entero Therapeutics,,2.0,,Sponsor asset acquired by another pharma company who opened their own IND for this compound. First Wave Bio never started this study in the US or ex-US.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,INDUSTRY,,,,,,,2022,0.0
NCT04594941,,2020-09-29,2023-05-26,,2023-07-10,2020-10-14,2020-10-20,ACTUAL,2023-07-10,2023-08-01,ACTUAL,,,,2023-07-10,2023-08-01,ACTUAL,2022-01-27,ACTUAL,2022-01-27,2023-07,2023-07-31,2022-05-26,ACTUAL,2022-05-26,2022-05-26,ACTUAL,2022-05-26,,INTERVENTIONAL,,,A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes,"A Descriptive, Comparative, Randomized, Crossover Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion Imaging Quality Using High Performance Liquid Chromatography (HPLC) and Solid Phase Extraction (SPE) Manufacturing Processes",COMPLETED,,PHASE2,38.0,ACTUAL,GE Healthcare,,4.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,INDUSTRY,,,,,,,2022,1.0
NCT03973697,,2019-04-17,2023-10-06,2022-06-16,2023-10-06,2019-06-03,2019-06-04,ACTUAL,2023-10-06,2023-11-01,ACTUAL,2022-06-16,2022-06-21,ACTUAL,2023-10-06,2023-11-01,ACTUAL,2020-01-13,ACTUAL,2020-01-13,2023-10,2023-10-31,2021-12-31,ACTUAL,2021-12-31,2021-08-11,ACTUAL,2021-08-11,,INTERVENTIONAL,,,Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection,"A Phase II, Randomized Trial to Evaluate the Optimal Dosing of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products for Recurrent Clostridium Difficile Infection",TERMINATED,,PHASE2,9.0,ACTUAL,University of Pennsylvania,,2.0,,Administrative reasons,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,OTHER,,,,,,,2021,0.0
NCT02332291,,2014-12-30,2021-07-30,,2021-08-25,2015-01-02,2015-01-06,ESTIMATED,2021-08-25,2021-09-21,ACTUAL,,,,2021-08-25,2021-09-21,ACTUAL,2015-04,ACTUAL,2015-04-30,2021-08,2021-08-31,2020-08,ACTUAL,2020-08-31,2020-08,ACTUAL,2020-08-31,,INTERVENTIONAL,CAARE,Participants randomized in 2:1 drug:placebo ratio.,Connectivity Affecting the Antidepressant REsponse Study,Connectivity Affecting the Antidepressant REsponse (The CAARE Study),COMPLETED,,PHASE4,95.0,ACTUAL,Vanderbilt University Medical Center,Single-site study; some missing data for self-report other outcome data,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 01:42:45.200039,2024-10-15 01:42:45.200039,OTHER,,,,,,,2020,1.0
NCT03078855,,2017-03-08,2024-07-11,,2024-08-08,2017-03-10,2017-03-13,ACTUAL,2024-08-08,2024-09-04,ACTUAL,,,,2024-08-08,2024-09-04,ACTUAL,2017-09-07,ACTUAL,2017-09-07,2024-08,2024-08-31,2024-07-02,ACTUAL,2024-07-02,2023-07-21,ACTUAL,2023-07-21,,INTERVENTIONAL,ILyAD,The baseline analysis population included randomized and eligible participants that received at least one dose of vitamin D or placebo. Five enrolled participants were either ineligible or withdrew before receiving at least one dose of vitamin D or placebo and were excluded from the baseline analysis population.,A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma,"ILyAD (Indolent Lymphoma And Vitamin D) A Phase III Double Blind, Randomized Trial to Evaluate the Effect of Vitamin D on Progression-free Survival in Patients With Low Tumor-burden Indolent Non-Hodgkin Lymphoma Treated With Rituximab",COMPLETED,,PHASE3,211.0,ACTUAL,University of Rochester,,2.0,,,f,,,,t,t,f,,,f,,,Data requests will be considered beginning in December 2024.,,,YES,De-identified data will be made available to researchers upon reasonable request.,2024-10-15 01:42:45.200039,2024-10-15 01:42:45.200039,OTHER,,,,,,,2024,1.0
NCT03504501,,2018-04-11,,,2023-11-29,2018-04-11,2018-04-20,ACTUAL,,,,,,,2023-11-29,2023-11-30,ACTUAL,2019-03-22,ACTUAL,2019-03-22,2023-05,2023-05-31,2023-10-31,ACTUAL,2023-10-31,2023-02-09,ACTUAL,2023-02-09,,INTERVENTIONAL,SynCoRAS,,Synaptic Plasticity and Cognitive Function in RASopathies,Improvement of Synaptic Plasticity and Cognitive Function in RAS Pathway Disorders,TERMINATED,,PHASE2,16.0,ACTUAL,Technical University of Munich,,3.0,,The study has been terminated prematurely due to recruitment difficulties. Current status: recruitment stopped and cleaning of the database is ongoing.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 11:58:31.365754,2024-10-16 11:58:31.365754,OTHER,,,,,,,2023,0.0
NCT03796676,,2019-01-04,2021-03-18,,2022-04-12,2019-01-04,2019-01-08,ACTUAL,2021-05-10,2021-06-04,ACTUAL,,,,2022-04-12,2022-04-13,ACTUAL,2019-02-18,ACTUAL,2019-02-18,2022-04,2022-04-30,2020-04-08,ACTUAL,2020-04-08,2020-04-08,ACTUAL,2020-04-08,,INTERVENTIONAL,JADE TEEN,Baseline analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received.,JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis,"A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 CO-ADMINISTERED WITH BACKGROUND MEDICATED TOPICAL THERAPY IN ADOLESCENT PARTICIPANTS 12 TO <18 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS",COMPLETED,,PHASE3,287.0,ACTUAL,Pfizer,,3.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,INDUSTRY,,,,,,,2020,1.0
NCT02117713,,2014-04-16,2021-05-28,,2021-06-29,2014-04-16,2014-04-21,ESTIMATED,2021-05-28,2021-06-22,ACTUAL,,,,2021-06-29,2021-07-01,ACTUAL,2015-03-16,ACTUAL,2015-03-16,2021-06,2021-06-30,2020-06-01,ACTUAL,2020-06-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,IMAGINE-II,"In the lead-in Study LUM001-301, participants were randomized to receive either placebo or active drug (MRX). The last observation obtained before first dose of MRX (either for participants who received MRX or placebo LUM001-301) was used as the MRX baseline observation for all calculations of change. For participants who were assigned MRX in LUM001-301, results at each post-baseline analysis visit included up to 13 more weeks of treatment than participants who were assigned placebo.",An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome,"A Multicenter Extension Study to Evaluate the Long-Term Safety and Durability of the Therapeutic Effect of LUM001, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome",COMPLETED,,PHASE2,34.0,ACTUAL,"Mirum Pharmaceuticals, Inc.",Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,INDUSTRY,,,,,,,2020,1.0
NCT03857841,,2019-02-20,2021-08-24,,2021-09-15,2019-02-27,2019-02-28,ACTUAL,2021-09-15,2021-10-12,ACTUAL,,,,2021-09-15,2021-10-12,ACTUAL,2019-10-09,ACTUAL,2019-10-09,2021-09,2021-09-30,2021-05-20,ACTUAL,2021-05-20,2021-05-20,ACTUAL,2021-05-20,,INTERVENTIONAL,,All subjects randomized and received clinical study material,A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD,A Safety Study of Intravenous Infusion of Bone Marrow Mesenchymal Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia,TERMINATED,,PHASE1,3.0,ACTUAL,United Therapeutics,,4.0,,The study was discontinued due to a business decision; no safety concerns were noted.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:24:52.208295,2024-10-15 15:24:52.208295,INDUSTRY,,,,,,,2021,0.0
NCT05703464,,2023-01-19,,,2023-03-07,2023-01-19,2023-01-30,ACTUAL,,,,,,,2023-03-07,2023-03-09,ACTUAL,2023-02-09,ACTUAL,2023-02-09,2023-03,2023-03-31,2023-03-03,ACTUAL,2023-03-03,2023-03-03,ACTUAL,2023-03-03,,INTERVENTIONAL,,,Elobixibat for Chronic Constipation Without Defecation Desire,"A Multicenter, Single-group, Open-label, Before-and-after Study Confirming Recovery of Defecation Desire by Administration of Elobixibat in Patients With Chronic Constipation",TERMINATED,,PHASE4,40.0,ACTUAL,International University of Health and Welfare,,1.0,,Personal reason,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,OTHER,,,,,,,2023,0.0
NCT03557684,,2018-06-05,2022-11-21,,2023-06-06,2018-06-05,2018-06-15,ACTUAL,2023-06-06,2023-06-08,ACTUAL,,,,2023-06-06,2023-06-08,ACTUAL,2018-09-01,ACTUAL,2018-09-01,2023-06,2023-06-30,2021-07-31,ACTUAL,2021-07-31,2021-07-31,ACTUAL,2021-07-31,,INTERVENTIONAL,,,Leucine for Depression Study (L-DEP),An Experimental Treatment Approach for Inflammation-Induced Depression,TERMINATED,,EARLY_PHASE1,59.0,ACTUAL,"University of California, Los Angeles",,4.0,,COVID-19,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,OTHER,,,,,,,2021,0.0
NCT03684642,,2018-09-24,2021-10-04,,2021-10-28,2018-09-24,2018-09-26,ACTUAL,2021-10-28,2021-11-01,ACTUAL,,,,2021-10-28,2021-11-01,ACTUAL,2018-09-26,ACTUAL,2018-09-26,2021-10,2021-10-31,2020-11-17,ACTUAL,2020-11-17,2020-10-13,ACTUAL,2020-10-13,,INTERVENTIONAL,AMPLITUDE-D,"Analysis was performed on intent-to-treat (ITT) population, which included all randomized participants, analyzed according to the treatment group allocated by randomization.",Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin,"A 56-week, Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly Compared to Dulaglutide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin",TERMINATED,,PHASE3,908.0,ACTUAL,Sanofi,"The study was terminated early by the Sponsor on 09 September 2020. Due to early termination of the study, model-based efficacy analyses were performed in the mITT population instead of the ITT population originally planned and data was carefully considered given that the study was terminated early.",3.0,,"Sponsor decision to cancel TRIAL, not related to safety concern.",f,,,,t,t,f,,,,,,,,,NO,No plan to share individual participant data (IPD) by SANOFI: Product rights transferred to Hanmi Pharmaceutical.,2024-10-16 02:29:55.66105,2024-10-16 02:29:55.66105,INDUSTRY,,,,,,,2020,0.0
NCT04005144,,2019-06-28,,,2022-10-13,2019-06-28,2019-07-02,ACTUAL,,,,,,,2022-10-13,2022-10-17,ACTUAL,2020-02-25,ACTUAL,2020-02-25,2022-10,2022-10-31,2022-10-01,ACTUAL,2022-10-01,2022-10-01,ACTUAL,2022-10-01,,INTERVENTIONAL,,,Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer,A Phase I Study of Brigatinib With Binimetinib in Advanced ALK- or ROS1-Rearranged Non-Small Cell Lung Cancer (NSCLC),TERMINATED,,PHASE1,3.0,ACTUAL,"University of California, San Francisco",,1.0,,Low Accrual,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,OTHER,,,,,,,2022,0.0
NCT03877224,,2019-02-21,2021-07-06,,2021-11-15,2019-03-14,2019-03-15,ACTUAL,2021-11-15,2021-11-17,ACTUAL,,,,2021-11-15,2021-11-17,ACTUAL,2019-04-04,ACTUAL,2019-04-04,2021-11,2021-11-30,2020-07-09,ACTUAL,2020-07-09,2020-07-09,ACTUAL,2020-07-09,,INTERVENTIONAL,,"Full Analysis Set: All participants that were randomized, regardless of whether treated or not.",DETERMINE-preserved - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Preserved Ejection Fraction,"International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients With Preserved Ejection Fraction",COMPLETED,,PHASE3,504.0,ACTUAL,AstraZeneca,"In this study, a subset of participants received wearable activity monitors to wear at home for 3 periods of 7 days. Data collection from the wearable device was challenging and a substantial amount of data was missing. This limits the use of the data based on the wearable activity monitors to investigate the potential impact of study drug on the amount, duration, and intensity of physical activity.",2.0,,,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,INDUSTRY,,,,,,,2020,1.0
NCT03163459,,2017-05-06,,,2020-08-01,2017-05-20,2017-05-23,ACTUAL,,,,,,,2020-08-01,2020-08-04,ACTUAL,2018-02-06,ACTUAL,2018-02-06,2020-08,2020-08-31,2020-12-16,ESTIMATED,2020-12-16,2020-09-30,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,Short-duration Selective Brain Cooling for Patients Undergoing Mechanical Thrombectomy,Short-duration Selective Brain Cooling for Ischemic Stroke Patients Undergoing Mechanical Thrombectomy: a Randomized Controlled Trial,SUSPENDED,,PHASE2/PHASE3,120.0,ESTIMATED,Capital Medical University,,2.0,,Interim analysis,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,OTHER,,,,,,,2020,0.0
NCT03697564,,2018-09-28,,,2023-04-27,2018-10-03,2018-10-05,ACTUAL,,,,,,,2023-04-27,2023-04-28,ACTUAL,2019-10-31,ACTUAL,2019-10-31,2023-01,2023-01-31,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).,"Open Label Randomized Phase II Trial of Nivolumab + Cabiralizumab (BMS-986227, FPA008) + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).",SUSPENDED,,PHASE2,40.0,ESTIMATED,"University of California, San Diego",,1.0,,Working on getting accurate information for patients interested in the study.,,,,,,t,f,,,,,,,,,,,2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,OTHER,,,,,,,2023,0.0
NCT03417921,,2018-01-22,,,2024-07-30,2018-01-29,2018-01-31,ACTUAL,,,,,,,2024-07-30,2024-07-31,ACTUAL,2021-04-26,ACTUAL,2021-04-26,2024-07,2024-07-31,2024-12-31,ESTIMATED,2024-12-31,2023-04-26,ACTUAL,2023-04-26,,INTERVENTIONAL,Pancreatic,,A Study of ABTL0812 in Pancreatic Cancer,A Randomized Phase I/II Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Metastatic Pancreatic Cancer at First Line Therapy,SUSPENDED,,PHASE1/PHASE2,60.0,ESTIMATED,Ability Pharmaceuticals SL,,2.0,,We opened another study.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 15:24:52.208295,2024-10-15 15:24:52.208295,INDUSTRY,,,,,,,2024,0.0
NCT02672358,,2016-02-01,,,2018-08-08,2016-02-01,2016-02-03,ESTIMATED,,,,,,,2018-08-08,2018-08-10,ACTUAL,2018-09-03,ESTIMATED,2018-09-03,2018-08,2018-08-31,2020-12-07,ESTIMATED,2020-12-07,2019-09-02,ESTIMATED,2019-09-02,,INTERVENTIONAL,,,Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC,"A Phase II, Multi-center, Single Arm, Open Label Study to Assess Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer",WITHDRAWN,,PHASE2,0.0,ACTUAL,Novartis,,1.0,,Company Decision,f,,,,f,f,f,,,,,,,,,UNDECIDED,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,INDUSTRY,,,,,,,2020,0.0
NCT03992443,,2019-06-18,,,2022-04-08,2019-06-19,2019-06-20,ACTUAL,,,,,,,2022-04-08,2022-04-15,ACTUAL,2022-02-28,ACTUAL,2022-02-28,2022-04,2022-04-30,2022-03-18,ACTUAL,2022-03-18,2022-03-18,ACTUAL,2022-03-18,,INTERVENTIONAL,READY 2,,Efficacy and Safety of CUSA-081 in the Restoration of Dysfunctional Central Venous Access Device (CVAD) Functionality,"A Phase 3, Open Label, Single Arm Study on the Use of CUSA-081 for Dysfunctional Central Venous Access Devices (CVADs)",WITHDRAWN,,PHASE3,0.0,ACTUAL,Chiesi Farmaceutici S.p.A.,,1.0,,Chiesi business decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:42:45.200039,2024-10-15 01:42:45.200039,INDUSTRY,,,,,,,2022,0.0
NCT04908475,,2021-05-28,2024-04-02,,2024-04-02,2021-05-28,2021-06-01,ACTUAL,2024-04-02,2024-04-30,ACTUAL,,,,2024-04-02,2024-04-30,ACTUAL,2021-06-09,ACTUAL,2021-06-09,2024-04,2024-04-30,2023-04-20,ACTUAL,2023-04-20,2023-04-20,ACTUAL,2023-04-20,,INTERVENTIONAL,,,Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy,"A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor-blinded Study of Risankizumab Compared to Apremilast for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy",COMPLETED,,PHASE4,352.0,ACTUAL,AbbVie,,2.0,,,f,,,,f,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,INDUSTRY,,,,,,,2023,1.0
NCT01593254,,2012-05-04,2018-11-08,,2023-05-30,2012-05-07,2012-05-08,ESTIMATED,2019-03-21,2019-04-11,ACTUAL,,,,2023-05-30,2023-06-22,ACTUAL,2012-09-12,ACTUAL,2012-09-12,2023-05,2023-05-31,2022-04-12,ACTUAL,2022-04-12,2017-11-08,ACTUAL,2017-11-08,,INTERVENTIONAL,DASCERN,All Randomized participants,Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib,"An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib",COMPLETED,,PHASE2,262.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,INDUSTRY,,,,,,,2022,1.0
NCT04333225,,2020-04-01,2021-08-02,,2021-08-18,2020-04-02,2020-04-03,ACTUAL,2021-08-18,2021-08-20,ACTUAL,,,,2021-08-18,2021-08-20,ACTUAL,2020-04-03,ACTUAL,2020-04-03,2020-05,2020-05-31,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers,A Prospective Clinical Study of Hydroxychloroquine in the Prevention of SARS- CoV-2 (COVID-19) Infection in Healthcare Workers After High-risk Exposures,COMPLETED,,PHASE2,221.0,ACTUAL,Baylor Research Institute,"* Due to the off-label use of HCQ, we were not able to incorporate randomization in our design.~* The outcome of CLI was based on self-reported symptoms, which is prone to bias.~* The trial may be under-powered as recruitment was forced to stop early at 221 instead of 360 because of the demand for and subsequent shortage of HCQ in March 2020.~* Our study participants were young and healthy compared to other prophylaxis trials, which may partially explain the low rates of COVID-19.",2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,OTHER,,,,,,,2020,1.0
NCT04616105,,2020-10-29,,,2021-11-04,2020-10-29,2020-11-04,ACTUAL,,,,,,,2021-11-04,2021-11-11,ACTUAL,2020-11-18,ACTUAL,2020-11-18,2021-10,2021-10-31,2021-05-28,ACTUAL,2021-05-28,2021-05-28,ACTUAL,2021-05-28,,INTERVENTIONAL,,,"Study of the Safety, Tolerability, and Pharmacokinetics of REGN6490 in Healthy Japanese Adult Volunteers","A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN6490 in Healthy Japanese Volunteers",TERMINATED,,PHASE1,19.0,ACTUAL,Regeneron Pharmaceuticals,,4.0,,Sponsor decision,f,,,,f,t,f,,,,,,"When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.",Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf,https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-16 23:38:54.744742,2024-10-16 23:38:54.744742,INDUSTRY,,,,,,,2021,0.0
NCT02675842,,2016-01-28,,,2021-10-28,2016-02-04,2016-02-05,ESTIMATED,,,,,,,2021-10-28,2021-11-01,ACTUAL,,,,2021-10,2021-10-31,2021-10-28,ACTUAL,2021-10-28,2021-10-28,ACTUAL,2021-10-28,,INTERVENTIONAL,,,Investigation of Cannabis for Pain and Inflammation in Lung Cancer,Investigation of Cannabis for Pain and Inflammation in Lung Cancer,WITHDRAWN,,PHASE1,0.0,ACTUAL,New York State Psychiatric Institute,,2.0,,funding,f,,,,t,,,,,,,,,,,NO,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,OTHER,,,,,,,2021,0.0
NCT04135352,,2019-10-10,,,2022-11-01,2019-10-18,2019-10-22,ACTUAL,,,,,,,2022-11-01,2022-11-04,ACTUAL,2019-11-04,ACTUAL,2019-11-04,2022-10,2022-10-31,2022-08-24,ACTUAL,2022-08-24,2022-08-24,ACTUAL,2022-08-24,,INTERVENTIONAL,,,A Study of Intratumoral/Intralesional Administration of V938 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic or Recurrent Malignancies (V938-001),"A Phase 1/1b, Open-label Clinical Study of Intratumoral/Intralesional Administration of V938 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic or Recurrent Malignancies",TERMINATED,,PHASE1,35.0,ACTUAL,Merck Sharp & Dohme LLC,,9.0,,Business Reasons,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 11:58:31.365754,2024-10-16 11:58:31.365754,INDUSTRY,,,,,,,2022,0.0
NCT03246919,,2017-08-04,,,2020-06-16,2017-08-08,2017-08-11,ACTUAL,,,,,,,2020-06-16,2020-06-18,ACTUAL,2017-09-13,ACTUAL,2017-09-13,2019-08,2019-08-31,2020-02-24,ACTUAL,2020-02-24,2020-02-24,ACTUAL,2020-02-24,,INTERVENTIONAL,I-TOPICS,,Ideal Time of Oxytocin Infusion During Cesarean Section,Ideal Time of Oxytocin Infusion During Cesarean Section,TERMINATED,,PHASE4,68.0,ACTUAL,Loyola University,,2.0,,PI left Loyola and Sub-I graduated.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,OTHER,,,,,,,2020,0.0
NCT05156645,,2021-12-09,,,2022-01-11,2021-12-09,2021-12-14,ACTUAL,,,,,,,2022-01-11,2022-01-27,ACTUAL,2022-01-15,ESTIMATED,2022-01-15,2021-12,2021-12-31,2022-12-01,ESTIMATED,2022-12-01,2022-12-01,ESTIMATED,2022-12-01,,INTERVENTIONAL,,,A Study to Evaluate Efficacy and Safety of the Combination of SCTA01 & SCTA01C in Outpatients With COVID-19,An Adaptive Phase I/II/III Trial to Evaluate the Efficacy and Safety of Anti-SARS-CoV-2 Monoclonal Antibody Combination (SCTA01C and SCTA01) for Treatment of Outpatients With COVID-19,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Sinocelltech Ltd.,,2.0,,The study was withdraw due to the fast spread of Omicron variant worldwide,f,,,,t,t,f,,,,,,,,,YES,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,INDUSTRY,,,,,,,2022,0.0
NCT03182907,,2017-06-08,2023-04-06,,2023-07-25,2017-06-08,2017-06-09,ACTUAL,2023-05-11,2023-06-07,ACTUAL,,,,2023-07-25,2023-07-27,ACTUAL,2018-03-27,ACTUAL,2018-03-27,2023-07,2023-07-31,2022-05-12,ACTUAL,2022-05-12,2022-05-12,ACTUAL,2022-05-12,,INTERVENTIONAL,MODIFY III,,Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001),"A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Infusion of Bezlotoxumab (MK-6072, Human Monoclonal Antibody to C. Difficile Toxin B) in Children Aged 1 to <18 Years Receiving Antibacterial Drug Treatment for C. Difficile Infection (MODIFY III)",COMPLETED,,PHASE3,148.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 01:42:45.200039,2024-10-15 01:42:45.200039,INDUSTRY,,,,,,,2022,1.0
NCT05220748,,2022-01-11,,,2023-04-14,2022-02-01,2022-02-02,ACTUAL,,,,,,,2023-04-14,2023-04-19,ACTUAL,2022-03-24,ACTUAL,2022-03-24,2023-04,2023-04-30,2023-01-30,ACTUAL,2023-01-30,2023-01-30,ACTUAL,2023-01-30,,INTERVENTIONAL,,,"RM-1995 Photoimmunotherapy, as Monotherapy or Combined With Pembrolizumab, in Patients With Advanced CuSCC and HNSCC","A Phase 1 First-in-Human, Drug-dose Escalation Study of RM-1995 Photoimmunotherapy, as Monotherapy or Combined With Pembrolizumab, in Patients With Advanced Cutaneous Squamous Cell Carcinoma or With Head and Neck Squamous Cell Carcinoma",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Rakuten Medical, Inc.",,2.0,,Decision was made due to a strategic re-evaluation of pipelines; no patients were enrolled.,f,,,,f,t,t,t,,,,,,,,NO,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,INDUSTRY,,,,,,,2023,0.0
NCT03850535,,2019-02-20,2021-09-05,,2022-06-16,2019-02-20,2019-02-21,ACTUAL,2022-06-16,2022-06-21,ACTUAL,,,,2022-06-16,2022-06-21,ACTUAL,2019-03-25,ACTUAL,2019-03-25,2022-06,2022-06-30,2020-09-10,ACTUAL,2020-09-10,2020-09-10,ACTUAL,2020-09-10,,INTERVENTIONAL,,There was no expansion phase taken place.,A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission,A Phase Ib/II Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission,TERMINATED,,PHASE1/PHASE2,24.0,ACTUAL,Hoffmann-La Roche,,4.0,,Sponsor's decision to terminate the study after Phase 1; will not proceed with Phase 2.,f,,,,f,t,f,,,,,,,,,NO,"Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).~For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 01:42:45.200039,2024-10-15 01:42:45.200039,INDUSTRY,,,,,,,2020,0.0
NCT03370185,,2017-11-29,,,2023-02-24,2017-12-05,2017-12-12,ACTUAL,,,,,,,2023-02-24,2023-02-28,ACTUAL,2018-02-12,ACTUAL,2018-02-12,2023-02,2023-02-28,2021-03,ESTIMATED,2021-03-31,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,BRIO,,Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma,A Phase 2 Study of Duvelisib Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Previously Treated With a Bruton's Tyrosine Kinase Inhibitor (BTKi),WITHDRAWN,,PHASE2,0.0,ACTUAL,SecuraBio,,1.0,,Reassessing corporate priorities.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,INDUSTRY,,,,,,,2021,0.0
NCT04056650,,2019-08-09,,,2021-03-10,2019-08-13,2019-08-14,ACTUAL,,,,,,,2021-03-10,2021-03-12,ACTUAL,2019-10-18,ACTUAL,2019-10-18,2021-03,2021-03-31,2020-12-22,ACTUAL,2020-12-22,2020-12-22,ACTUAL,2020-12-22,,INTERVENTIONAL,,,Assessing the Effectiveness of an N-of-1 Platform Using Study of Cognitive Enhancers,Data Driven Health Decisions in the Wild: A Platform for Actionable N-of-1 Studies,TERMINATED,,PHASE4,57.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,2.0,,Low enrollment,f,,,,f,t,f,,,,,,,,,YES,,2024-10-16 11:58:31.365754,2024-10-16 11:58:31.365754,OTHER,,,,,,,2020,0.0
NCT02346617,,2015-01-13,,,2020-03-18,2015-01-26,2015-01-27,ESTIMATED,,,,,,,2020-03-18,2020-03-20,ACTUAL,2022-01-01,ESTIMATED,2022-01-01,2020-03,2020-03-31,2024-12-01,ESTIMATED,2024-12-01,2023-12-01,ESTIMATED,2023-12-01,,INTERVENTIONAL,,,Adoptive Transfer of pp65-specific T Cells for the Treatment of Refractory Cytomegalovirus (CMV) Infection,Adoptive Transfer of pp65-specific T Cells for the Treatment of Refractory Cytomegalovirus (CMV) Infection in Allogeneic Hematopoietic Cell Transplant Recipients,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Samsung Medical Center,,1.0,,Due to the KoreaFDA issue,f,,,,t,f,f,,,,,,,,,,,2024-10-15 01:42:45.200039,2024-10-15 01:42:45.200039,OTHER,,,,,,,2024,0.0
NCT03088813,,2017-03-09,2023-08-17,2023-01-31,2024-06-20,2017-03-17,2017-03-23,ACTUAL,2023-09-27,2023-10-17,ACTUAL,,2023-10-17,ACTUAL,2024-06-20,2024-07-17,ACTUAL,2018-04-25,ACTUAL,2018-04-25,2024-06,2024-06-30,2023-07-27,ACTUAL,2023-07-27,2022-02-08,ACTUAL,2022-02-08,,INTERVENTIONAL,RESILIENT,Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection. Part 2: Intent-to-Treat (ITT) population included all randomized participants.,Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer,"RESILIENT: A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Progressed on or After Platinum-based First-Line Therapy",COMPLETED,,PHASE3,491.0,ACTUAL,Ipsen,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 01:42:45.200039,2024-10-15 01:42:45.200039,INDUSTRY,,,,,,,2023,1.0
NCT04720742,,2019-12-12,,,2022-08-02,2021-01-19,2021-01-22,ACTUAL,,,,,,,2022-08-02,2022-08-03,ACTUAL,2021-02-28,ACTUAL,2021-02-28,2022-08,2022-08-31,2022-03-28,ACTUAL,2022-03-28,2022-03-28,ACTUAL,2022-03-28,,INTERVENTIONAL,ITATI,,Immune Therapy and Analytical Treatment Interruption in HIV+ Participants Who Received an Allogeneic Stem Cell Transplantation,Immune Therapy and Analytical Treatment Interruption in HIV+ Participants Who Received an Allogeneic Stem Cell Transplantation (ITATI),WITHDRAWN,,PHASE2,0.0,ACTUAL,IrsiCaixa,,1.0,,"Due to the COVID-19 pandemic the financial sponsor of the trial suspended the study funding due to funding limitations and based on various considerations, including the uncertainties of conducting the study in the volatile scenario of this pandemic.",f,,,,t,f,f,,,,,,,,,,,2024-10-15 01:42:45.200039,2024-10-15 01:42:45.200039,OTHER,,,,,,,2022,0.0
NCT02174575,,2014-06-20,,,2023-05-01,2014-06-23,2014-06-25,ESTIMATED,,,,,,,2023-05-01,2023-05-03,ACTUAL,2014-07,,2014-07-31,2023-05,2023-05-31,2023-05,ACTUAL,2023-05-31,2023-05,ACTUAL,2023-05-31,,INTERVENTIONAL,,,Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery,Effects of Different Inhalational Anesthetic Agents on the Incidence of Clinical and Subclinical Acute Kidney Injury After Liver Resection Surgery: a Pilot Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,Tokyo Medical and Dental University,,2.0,,I retired my post before enrollment,f,,,,f,,,,,,,,,,,,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,OTHER,,,,,,,2023,0.0
NCT04055168,,2019-07-15,,,2020-12-11,2019-08-12,2019-08-13,ACTUAL,,,,,,,2020-12-11,2020-12-14,ACTUAL,2019-07-24,ACTUAL,2019-07-24,2020-12,2020-12-31,2020-02-10,ACTUAL,2020-02-10,2020-02-10,ACTUAL,2020-02-10,,INTERVENTIONAL,,,"A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6615 in Healthy Subjects","A Phase I Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6615 After Single Dosing to Healthy Subjects",TERMINATED,,PHASE1,24.0,ACTUAL,AstraZeneca,,5.0,,It was decided to not run the Japanese cohorts in the study.,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 15:24:52.208295,2024-10-15 15:24:52.208295,INDUSTRY,,,,,,,2020,0.0
NCT04002037,,2019-06-21,2023-12-04,,2024-06-05,2019-06-26,2019-06-28,ACTUAL,2024-06-05,2024-06-26,ACTUAL,,,,2024-06-05,2024-06-26,ACTUAL,2019-06-25,ACTUAL,2019-06-25,2024-06,2024-06-30,2023-01-01,ACTUAL,2023-01-01,2022-05-19,ACTUAL,2022-05-19,,INTERVENTIONAL,,,Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis,Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis: A Double-Blind Prospective Randomized Clinical Trial,TERMINATED,,PHASE4,95.0,ACTUAL,University of Missouri-Columbia,,3.0,,Preliminary analysis revealed no difference,f,,,,,t,f,,,f,,,,,,,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,OTHER,,,,,,,2023,0.0
NCT03846570,,2019-02-14,,,2023-02-28,2019-02-18,2019-02-19,ACTUAL,,,,,,,2023-02-28,2023-03-01,ACTUAL,2019-01-29,ACTUAL,2019-01-29,2023-02,2023-02-28,2022-07-05,ACTUAL,2022-07-05,2022-07-05,ACTUAL,2022-07-05,,INTERVENTIONAL,FORZA,,Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial,Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial,TERMINATED,,PHASE3,34.0,ACTUAL,Erasmus Medical Center,,2.0,,Insufficient inclusion rate (due to COVID-19 pandemic),f,,,,t,f,f,,,f,,,36 months after publication,"Data can be requested immediately following publication up to 36 months, after which the data will be filed in the Erasmus MC respiratory medicine department archives without further research support. Data requests are to be addressed to: research.longziekten@erasmusmc.nl",,YES,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,OTHER,,,,,,,2022,0.0
NCT04441385,,2020-06-18,,,2022-02-24,2020-06-18,2020-06-22,ACTUAL,,,,,,,2022-02-24,2022-03-11,ACTUAL,2020-06-26,ACTUAL,2020-06-26,2020-07,2020-07-31,2021-02-08,ACTUAL,2021-02-08,2021-02-08,ACTUAL,2021-02-08,,INTERVENTIONAL,MARACOVID,,Study to Evaluate the Efficacy and Safety of Maraviroc in SARS-CoV-2 Infection (COVID-19).,"Bicentric, Phase 2, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Maraviroc Associated With Standard Treatment in Hospitalized Patients With Pulmonary SARS-CoV-2 Infection (COVID-19).",TERMINATED,,PHASE2,60.0,ACTUAL,Hospital Universitario Infanta Leonor,,2.0,,lack of viability,f,,,,,f,f,,,f,,,,,,,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,OTHER,,,,,,,2021,0.0
NCT02697734,,2016-02-27,2021-07-26,2019-08-28,2021-10-20,2016-02-27,2016-03-03,ESTIMATED,2021-09-21,2021-10-19,ACTUAL,2019-08-28,2019-09-09,ACTUAL,2021-10-20,2021-11-01,ACTUAL,2016-10-03,ACTUAL,2016-10-03,2021-10,2021-10-31,2020-12-31,ACTUAL,2020-12-31,2019-06-19,ACTUAL,2019-06-19,,INTERVENTIONAL,LINC-4,,Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease,"A Phase III, Multi-center, Randomized, Double-blind, 48 Week Study With an Initial 12 Week Placebo-controlled Period to Evaluate the Safety and Efficacy of Osilodrostat in Patients With Cushing's Disease",COMPLETED,,PHASE3,73.0,ACTUAL,Novartis,,2.0,,,f,,,,t,t,f,,,,,,,,https://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,INDUSTRY,,,,,,,2020,1.0
NCT04110496,,2019-09-23,,,2022-12-07,2019-09-27,2019-10-01,ACTUAL,,,,,,,2022-12-07,2022-12-08,ACTUAL,2020-01-29,ACTUAL,2020-01-29,2022-12,2022-12-31,2022-12-01,ACTUAL,2022-12-01,2022-12-01,ACTUAL,2022-12-01,,INTERVENTIONAL,,,Safety and Tolerability of RTX-134 in Adults With Phenylketonuria,"A Phase 1b Open-Label Single Dose Safety, Tolerability, and Pharmacokinetics Study of RTX-134 in Adults With Phenylketonuria",TERMINATED,,PHASE1,1.0,ACTUAL,Rubius Therapeutics,,1.0,,The trial was discontinued by the Sponsor,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,INDUSTRY,,,,,,,2022,0.0
NCT04162301,,2019-10-29,,,2021-04-13,2019-11-11,2019-11-14,ACTUAL,,,,,,,2021-04-13,2021-04-15,ACTUAL,2019-12-30,ACTUAL,2019-12-30,2021-04,2021-04-30,2021-02-19,ACTUAL,2021-02-19,2021-02-19,ACTUAL,2021-02-19,,INTERVENTIONAL,,,A Study of CS3002 in Subjects With Advanced Solid Tumors,"A Phase I, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activities of CS3002, a CDK4/6 Inhibitor, in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,10.0,ACTUAL,CStone Pharmaceuticals,,1.0,,The study has been stopped for strategic and business reasons.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 11:58:31.365754,2024-10-16 11:58:31.365754,INDUSTRY,,,,,,,2021,0.0
NCT04111497,,2019-09-26,,,2023-09-11,2019-09-30,2019-10-01,ACTUAL,,,,,,,2023-09-11,2023-09-13,ACTUAL,2019-12-03,ACTUAL,2019-12-03,2023-09,2023-09-30,2023-08-23,ACTUAL,2023-08-23,2023-08-23,ACTUAL,2023-08-23,,INTERVENTIONAL,,,Glasdegib for Chronic Graft-Versus-Host Disease,"A Single-Arm, Open-Label, Phase I/II Study of Glasdegib for Sclerotic Chronic Graft-Vs-Host Disease",TERMINATED,,PHASE1/PHASE2,15.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,Study closed to accrual early due to side effects of study drug.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,OTHER,,,,,,,2023,0.0
NCT03584516,,2018-06-29,,,2024-01-23,2018-06-29,2018-07-12,ACTUAL,,,,,,,2024-01-23,2024-01-24,ACTUAL,2019-01-17,ACTUAL,2019-01-17,2024-01,2024-01-31,2023-11-03,ACTUAL,2023-11-03,2023-11-03,ACTUAL,2023-11-03,,INTERVENTIONAL,,,GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease,GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease,TERMINATED,,PHASE2/PHASE3,155.0,ACTUAL,Incyte Corporation,,3.0,,The study was terminated due to insufficient efficacy to support moving into Part 2 of the study; there were no safety concerns that contributed to this decision.,f,,,,t,t,f,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,INDUSTRY,,,,,,,2023,0.0
NCT04106362,,2019-09-25,,,2023-05-31,2019-09-25,2019-09-27,ACTUAL,,,,,,,2023-05-31,2023-06-01,ACTUAL,2020-01-14,ACTUAL,2020-01-14,2023-05,2023-05-31,2023-05-23,ACTUAL,2023-05-23,2023-05-23,ACTUAL,2023-05-23,,INTERVENTIONAL,,,"Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With HPV Positive, KRAS-Variant Stage III-IV Oropharyngeal Squamous Cell Carcinoma",Randomized Phase II Trial of Radiotherapy With Concurrent Cisplatin +/- Concurrent Cetuximab for HPV-Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC) in KRAS-Variant Patients,TERMINATED,,PHASE2,1.0,ACTUAL,Jonsson Comprehensive Cancer Center,,2.0,,low enrollment,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,OTHER,,,,,,,2023,0.0
NCT05727657,,2023-02-03,,,2024-08-13,2023-02-13,2023-02-14,ACTUAL,,,,,,,2024-08-13,2024-08-15,ACTUAL,2024-06,ESTIMATED,2024-06-30,2024-08,2024-08-31,2024-06-24,ACTUAL,2024-06-24,2024-06-24,ACTUAL,2024-06-24,,INTERVENTIONAL,SASH,,Satralizumab in Aneurysmal Subarachnoid Hemorrhage,A Phase 1 Clinical Trial of Satralizumab as a Treatment for Aneurysmal Subarachnoid Hemorrhage,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Florida,,1.0,,Lost support from the drug manufacturer,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 01:42:45.200039,2024-10-15 01:42:45.200039,OTHER,,,,,,,2024,0.0
NCT03781817,,2018-12-18,2023-01-18,,2023-04-19,2018-12-18,2018-12-20,ACTUAL,2023-04-19,2023-04-20,ACTUAL,,,,2023-04-19,2023-04-20,ACTUAL,2019-09-09,ACTUAL,2019-09-09,2023-04,2023-04-30,2022-04-30,ACTUAL,2022-04-30,2022-01-21,ACTUAL,2022-01-21,,INTERVENTIONAL,,,Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures,Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures,TERMINATED,,PHASE4,40.0,ACTUAL,University of Alabama at Birmingham,,2.0,,Transition/change of primary investigators,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 11:58:31.365754,2024-10-16 11:58:31.365754,OTHER,,,,,,,2022,0.0
NCT03502694,,2018-04-11,,,2018-11-14,2018-04-11,2018-04-19,ACTUAL,,,,,,,2018-11-14,2018-11-15,ACTUAL,2018-11-05,ESTIMATED,2018-11-05,2018-11,2018-11-30,2020-10-28,ESTIMATED,2020-10-28,2019-04-30,ESTIMATED,2019-04-30,,INTERVENTIONAL,STEP,,"Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Oral Lumicitabine Regimens in Hospitalized Adult Participants Infected With Human Metapneumovirus","A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Adult Subjects Infected With Human Metapneumovirus",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Janssen Research & Development, LLC",,3.0,,sponsor decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,INDUSTRY,,,,,,,2020,0.0
NCT03417245,,2018-01-25,2022-01-07,,2022-03-15,2018-01-30,2018-01-31,ACTUAL,2022-01-07,2022-02-04,ACTUAL,,,,2022-03-15,2022-03-28,ACTUAL,2018-03-01,ACTUAL,2018-03-01,2022-03,2022-03-31,2021-07-14,ACTUAL,2021-07-14,2021-01-26,ACTUAL,2021-01-26,,INTERVENTIONAL,,Analysis was performed on intent-to-treat (ITT) population which included all randomized participants analyzed according to the randomized arm.,A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients Without Inhibitors,"ATLAS-A/B: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, Without Inhibitory Antibodies to Factor VIII or IX",COMPLETED,,PHASE3,120.0,ACTUAL,Sanofi,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 11:58:31.365754,2024-10-16 11:58:31.365754,INDUSTRY,,,,,,,2021,1.0
NCT03422419,,2018-01-30,,,2018-10-30,2018-01-30,2018-02-05,ACTUAL,,,,,,,2018-10-30,2018-11-01,ACTUAL,2018-08-01,ESTIMATED,2018-08-01,2018-10,2018-10-31,2021-07-31,ESTIMATED,2021-07-31,2020-10-31,ESTIMATED,2020-10-31,,INTERVENTIONAL,PROGRESS,,TIPS or Anticoagulation in Portal Vein Thrombosis,"An Investigator-initiated, Multicentre, Randomized, Trial Comparing Anticoagulation Alone Versus Transjugular Intrahepatic Portosystemic Shunt (TIPS) and Anticoagulation in Patients With Recent Obstructive Portal Vein Thrombosis",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Insel Gruppe AG, University Hospital Bern",,2.0,,lack of funding,f,,,,f,f,f,,,f,,,,,,UNDECIDED,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,OTHER,,,,,,,2021,0.0
NCT03647423,,2018-08-09,,,2021-03-17,2018-08-23,2018-08-27,ACTUAL,,,,,,,2021-03-17,2021-03-19,ACTUAL,2018-08-31,ESTIMATED,2018-08-31,2018-08,2018-08-31,2022-08-30,ESTIMATED,2022-08-30,2020-08-31,ESTIMATED,2020-08-31,,INTERVENTIONAL,,,QUILT-3.091 NANT Chordoma Vaccine vs Radiation in Subjects With Unresectable Chordoma.,QUILT-3.091 NANT Chordoma Vaccine: A Randomized Phase 1b/2 Trial of the NANT Chordoma Vaccine vs. Radiation in Subjects With Unresectable Chordoma.,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"ImmunityBio, Inc.",,2.0,,Trial not initiated,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,INDUSTRY,,,,,,,2022,0.0
NCT03757403,,2018-11-25,,,2022-10-31,2018-11-27,2018-11-28,ACTUAL,,,,,,,2022-10-31,2022-11-03,ACTUAL,2020-05-01,ESTIMATED,2020-05-01,2022-10,2022-10-31,2020-12-31,ESTIMATED,2020-12-31,2020-11-30,ESTIMATED,2020-11-30,,INTERVENTIONAL,,,RDD1609 as a Treatment for Idiopathic Pruritus Ani,RDD1609 as a Treatment for Idiopathic Pruritus Ani: A Randomized Double Blinded Placebo Controlled Crossover Study,WITHDRAWN,,PHASE2,0.0,ACTUAL,RDD Pharma Ltd,,2.0,,Covid-19,f,,,,f,f,f,,,,,,,,,,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,INDUSTRY,,,,,,,2020,0.0
NCT04100590,,2019-09-19,2022-05-31,,2022-06-29,2019-09-20,2019-09-24,ACTUAL,2022-06-29,2022-06-30,ACTUAL,,,,2022-06-29,2022-06-30,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2022-06,2022-06-30,2020-01-31,ACTUAL,2020-01-31,2019-12-30,ACTUAL,2019-12-30,,INTERVENTIONAL,,,Eye Tracking as a Biomarker of Cannabis Effects,Eye Tracking as a Biomarker of Cannabis Effects,TERMINATED,,PHASE2,1.0,ACTUAL,New York State Psychiatric Institute,,2.0,,"During a piloting phase with our staff, the technology/eye-tracking device did not collect outcomes as expected.",f,,,,f,t,f,,,,,,,,,UNDECIDED,De-identified eye-behavior data will be available to other researchers.,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,OTHER,,,,,,,2020,0.0
NCT03681184,,2018-09-19,2020-12-22,2020-10-02,2024-08-08,2018-09-19,2018-09-21,ACTUAL,2020-12-22,2021-01-19,ACTUAL,2020-10-02,2020-10-12,ACTUAL,2024-08-08,2024-08-12,ACTUAL,2018-11-27,ACTUAL,2018-11-27,2024-07,2024-07-31,2024-01-12,ACTUAL,2024-01-12,2019-11-05,ACTUAL,2019-11-05,,INTERVENTIONAL,ILLUMINATE-A,"Full Analysis Set (FAS): All randomized participants who received any amount of study drug, was used for all baseline characteristics, except for 24-hour urinary oxalate excretion corrected for body surface area (BSA), which used the Safety Analysis Set (SAS): All participants who received any amount of study drug.",A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1,"ILLUMINATE-A: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study With an Extended Dosing Period to Evaluate the Efficacy and Safety of Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1",COMPLETED,,PHASE3,39.0,ACTUAL,Alnylam Pharmaceuticals,,2.0,,,t,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,INDUSTRY,,NCT04125472,APPROVED_FOR_MARKETING,,,,2024,1.0
NCT03317457,,2017-10-18,,,2023-06-14,2017-10-20,2017-10-23,ACTUAL,,,,,,,2023-06-14,2023-06-15,ACTUAL,2017-12-15,ACTUAL,2017-12-15,2023-06,2023-06-30,2022-08-12,ACTUAL,2022-08-12,2022-08-12,ACTUAL,2022-08-12,,INTERVENTIONAL,MEDISARC,,Durvalumab and Tremelimumab Compared to Doxorubicin in Patients With Advanced or Metastatic Soft Tissue Sarcoma,A Randomized Phase II Study of Durvalumab (MEDI4736) and Tremelimumab Compared to Doxorubicin in Patients With Advanced or Metastatic Soft Tissue Sarcoma,COMPLETED,,PHASE2,103.0,ACTUAL,AIO-Studien-gGmbH,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,OTHER,,,,,,,2022,1.0
NCT04278963,,2020-02-19,,,2021-07-04,2020-02-19,2020-02-20,ACTUAL,,,,,,,2021-07-04,2021-07-07,ACTUAL,2021-10,ESTIMATED,2021-10-31,2021-07,2021-07-31,2023-05,ESTIMATED,2023-05-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Yinhu Qingwen Decoction for the Treatment of Mild / Common CoVID-19,"Adaptive, Randomized, Single-blind, Three-arm Parallel Controlled Clinical Trial of Yinhu Qingwen Decoction in the Treatment of Mild / Common CoVID-19",SUSPENDED,,PHASE2/PHASE3,300.0,ESTIMATED,China Academy of Chinese Medical Sciences,,3.0,,There were no eligible patients in the paticipated centers.,f,,,,t,f,f,,,,,,,,,,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,OTHER,,,,,,,2023,0.0
NCT06188104,,2023-09-29,,,2024-01-02,2024-01-02,2024-01-03,ACTUAL,,,,,,,2024-01-02,2024-01-03,ACTUAL,2023-11-30,ACTUAL,2023-11-30,2023-08,2023-08-31,2023-12-01,ACTUAL,2023-12-01,2023-12-01,ACTUAL,2023-12-01,,INTERVENTIONAL,,,Efficacy of Topical 95% TCA in the Treatment of CIN 1 or Less After Low-grade Abnormality of Screening Test,Efficacy of Topical 95% Trichloroaceteic Acid in the Treatment of CIN 1 or Less After Low-grade Abnormality of Screening Test: A Randomized Controlled Trial,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Rajavithi Hospital,,6.0,,I have found it is quite difficult to conduct the work without changing some detail in original protocol. So we would like to re-start the study again with some modification.,f,,,,t,f,f,,,,,,,,,,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,OTHER_GOV,,,,,,,2023,0.0
NCT05095311,,2021-06-19,2023-05-15,,2024-02-10,2021-10-15,2021-10-27,ACTUAL,2024-02-10,2024-03-05,ACTUAL,,,,2024-02-10,2024-03-05,ACTUAL,2021-05-19,ACTUAL,2021-05-19,2024-02,2024-02-29,2022-04-27,ACTUAL,2022-04-27,2022-04-27,ACTUAL,2022-04-27,,INTERVENTIONAL,,,The Effect of Cetirizine HCl on Exercise-induced Arterial Hypoxemia in Highly-trained Swimmers,The Effect of Cetirizine HCl on Exercise-induced Arterial Hypoxemia in Highly-trained Swimmers,TERMINATED,,PHASE4,16.0,ACTUAL,Indiana University,,2.0,,The recruited population was no longer made available to participate in the study.,f,,,,f,t,f,,,t,,,Data will be made available upon degree certification (anticipated May 2022) and will be available indefinitely.,The dissertation document will be publicly available.,,YES,IPD will be published in the form of a dissertation document.,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,OTHER,,,,,,,2022,0.0
NCT05027048,,2021-08-18,2024-03-11,,2024-05-20,2021-08-25,2021-08-30,ACTUAL,2024-05-20,2024-06-11,ACTUAL,,,,2024-05-20,2024-06-11,ACTUAL,2022-04-04,ACTUAL,2022-04-04,2024-05,2024-05-31,2023-04-03,ACTUAL,2023-04-03,2023-03-29,ACTUAL,2023-03-29,,INTERVENTIONAL,CALBLOC,,Calcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery,"Calcium Chloride for Prevention of Blood Loss From Uterine Atony During Intrapartum Cesarean Delivery (CALBLOC): a Double Blind, Randomized, Placebo Controlled Trial and Nested Population Pharmacokinetic and Pharmacodynamic Analysis",COMPLETED,,PHASE3,120.0,ACTUAL,Stanford University,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,OTHER,,,,,,,2023,1.0
NCT05292976,,2022-03-15,,,2022-05-16,2022-03-15,2022-03-23,ACTUAL,,,,,,,2022-05-16,2022-05-20,ACTUAL,2022-04,ESTIMATED,2022-04-30,2022-05,2022-05-31,2022-12,ESTIMATED,2022-12-31,2022-10,ESTIMATED,2022-10-31,,INTERVENTIONAL,,,"Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg Albuterol Base/ Inhalation","Multi-center, Randomized, Double Blind, Double Dummy, Placebo and Active Controlled, Crossover Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg in Stable Mild Asthma Patients",WITHDRAWN,,PHASE3,0.0,ACTUAL,Aurobindo Pharma Ltd,,5.0,,Business reasons,f,,,,,t,f,,,f,,,,,,,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,INDUSTRY,,,,,,,2022,0.0
NCT03029247,,2017-01-20,2021-05-06,,2021-06-02,2017-01-20,2017-01-24,ESTIMATED,2021-06-02,2021-06-03,ACTUAL,,,,2021-06-02,2021-06-03,ACTUAL,2017-07-27,ACTUAL,2017-07-27,2021-06,2021-06-30,2020-07-09,ACTUAL,2020-07-09,2020-07-09,ACTUAL,2020-07-09,,INTERVENTIONAL,,,Anemia Study in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Blood Pressure (ASCEND-BP),"A Randomized, Open-label Study to Evaluate the Effect of Daprodustat on Blood Pressure in Subjects With Anemia Associated With Chronic Kidney Disease on Hemodialysis Switched From a Stable Dose of an Erythropoiesis-stimulating Agent",COMPLETED,,PHASE2,105.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,f,t,f,,,,,,IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 15:24:52.208295,2024-10-15 15:24:52.208295,INDUSTRY,,,,,,,2020,1.0
NCT02819635,,2016-06-28,2022-06-03,,2022-06-03,2016-06-28,2016-06-30,ESTIMATED,2022-06-03,2022-06-30,ACTUAL,,,,2022-06-03,2022-06-30,ACTUAL,2016-09-26,ACTUAL,2016-09-26,2022-06,2022-06-30,2021-12-13,ACTUAL,2021-12-13,2021-12-13,ACTUAL,2021-12-13,,INTERVENTIONAL,,Intent-to-treat (ITT) analysis set: Substudy 1 (all randomized participants who received at least one dose of study drug in Substudy 1); Substudy 2 (all randomized participants who received at least one dose of doubleblinded study drug in Part 1 and all participants who received at least one dose of upadacitinib 45 mg in Part 2); Substudy 3 (all M14-675 participants who received at least one dose of study drug in Substudy 3),A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC),"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis",COMPLETED,,PHASE2/PHASE3,1302.0,ACTUAL,AbbVie,,8.0,,,f,,,,t,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,INDUSTRY,,,,,,,2021,1.0
NCT04936113,,2021-06-15,,,2021-10-22,2021-06-15,2021-06-23,ACTUAL,,,,,,,2021-10-22,2021-10-28,ACTUAL,2021-06-02,ACTUAL,2021-06-02,2021-10,2021-10-31,2021-09-30,ACTUAL,2021-09-30,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,,,"Continued Safety Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in the FB401-01 Study","An Open-Label, Multicenter Study to Evaluate Continued Safety of FB-401 for up to 48 Weeks in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in FB401-01 Phase 2 Study",TERMINATED,,PHASE2,36.0,ACTUAL,"Forte Biosciences, Inc.",,1.0,,Failure of the Phase 2 study (protocol FB401-01) to meet its endpoint.,f,,,,,t,f,,,,,,,,,,,2024-10-16 23:45:11.633274,2024-10-16 23:45:11.633274,INDUSTRY,,,,,,,2021,0.0
NCT03273257,,2017-08-25,2021-05-05,,2021-05-31,2017-09-04,2017-09-06,ACTUAL,2021-05-31,2021-06-22,ACTUAL,,,,2021-05-31,2021-06-22,ACTUAL,2018-08-17,ACTUAL,2018-08-17,2021-05,2021-05-31,2020-05-05,ACTUAL,2020-05-05,2020-05-05,ACTUAL,2020-05-05,,INTERVENTIONAL,,All participants who received at least one dose of randomized study drug,Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study),"A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Multicentre, Prospective Study to Assess Efficacy of Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy With High Preoperative Pulmonary Vascular Resistance",TERMINATED,,PHASE2,14.0,ACTUAL,International CTEPH Association,"The study was terminated after enrolling only 14 out of 88 planned patients, due to slower than expected recruitment and the additional limitations on clinical research imposed by the COVID-19 pandemic. No firm conclusions can be drawn based on the study data due to the limited sample size.",2.0,,"The study was stopped due to slower than expected recruitment and the additional limitations on clinical research imposed by the COVID-19 pandemic, both of which made study completion within a reasonable timeframe appear unlikely.",f,,,,t,t,f,,,,,,,,,NO,IPD sharing is not foreseen,2024-10-16 11:58:31.365754,2024-10-16 11:58:31.365754,OTHER,,,,,,,2020,0.0
NCT01400607,,2011-07-20,,,2017-08-29,2011-07-21,2011-07-22,ESTIMATED,,,,,,,2017-08-29,2017-08-31,ACTUAL,2011-07,,2011-07-31,2016-09,2016-09-30,2020-09,ESTIMATED,2020-09-30,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,,,Neocartilage Implant to Treat Cartilage Lesions of the Knee,Randomized Controlled Trial to Evaluate the Efficacy of a Neocartilage Implant in the Management of ICRS Grade 3 to 4 Articular Cartilage Lesions of the Knee,TERMINATED,,PHASE3,14.0,ACTUAL,"ISTO Technologies, Inc.",,2.0,,Poor enrollment,f,,,,t,,,,,,,,,,,,,2024-10-16 11:58:31.365754,2024-10-16 11:58:31.365754,INDUSTRY,,,,,,,2020,0.0
NCT05366296,,2022-05-03,,,2023-04-25,2022-05-05,2022-05-09,ACTUAL,,,,,,,2023-04-25,2023-04-27,ACTUAL,2022-07,ESTIMATED,2022-07-31,2023-04,2023-04-30,2023-01,ESTIMATED,2023-01-31,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,"Safety, Reactogenicity, and Immunogenicity Study of a Lyophilized COVID-19 mRNA Vaccine","A Randomized, Observer-Blinded, Placebo-Controlled Phase I Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of One Dose Booster by A Lyophilized COVID-19 mRNA Vaccine in Adults Aged 18 to 60 Years",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Wuhan Recogen Biotechnology Co., Ltd.",,2.0,,business stragety,f,,,,,f,f,,,,,,,,,NO,There is not a plan to make individual participant data (IPD) available,2024-10-16 23:51:36.169984,2024-10-16 23:51:36.169984,INDUSTRY,,,,,,,2023,0.0
NCT04960397,,2021-07-08,,,2024-05-09,2021-07-08,2021-07-13,ACTUAL,,,,,,,2024-05-09,2024-05-10,ACTUAL,2021-09-10,ACTUAL,2021-09-10,2024-01,2024-01-31,2024-04-12,ACTUAL,2024-04-12,2024-04-12,ACTUAL,2024-04-12,,INTERVENTIONAL,,,Assess the Safety and Immunogenicity of One or Two Doses of Sing2016 M2SR H3N2 Influenza Vaccine,"A Phase 1b, Double-Blind, Randomized, Dose-Escalating, Age De-Escalating, Placebo-Controlled Study to Assess the Safety and Immunogenicity of One or Two Doses of Sing2016 M2SR H3N2 Influenza Vaccine Delivered Intranasally In a Healthy Pediatric Population 6 Months Through 17 Years of Age.",TERMINATED,,PHASE1,140.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,4.0,,Lack of product and funding.,f,,,,,t,f,,,f,,,,,,,,2024-10-16 23:51:36.169984,2024-10-16 23:51:36.169984,NIH,,,,,,,2024,0.0
NCT04750278,,2021-02-02,2023-11-08,,2024-01-04,2021-02-10,2021-02-11,ACTUAL,2024-01-04,2024-01-05,ACTUAL,,,,2024-01-04,2024-01-05,ACTUAL,2021-04-06,ACTUAL,2021-04-06,2022-08,2022-08-31,2022-04-18,ACTUAL,2022-04-18,2022-04-18,ACTUAL,2022-04-18,,INTERVENTIONAL,,Patients with COVID-19 acute respiratory distress syndrome who met the inclusion criteria of the protocol.,A Phase 2/3 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19,"A Phase 2/3, Randomized, Double Blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of FP-025 in Patients With Severe to Critical COVID 19 With Associated Acute Respiratory Distress Syndrome (ARDS)",TERMINATED,,PHASE2/PHASE3,90.0,ACTUAL,"Foresee Pharmaceuticals Co., Ltd.",,3.0,,"Study stopped at interim analysis point, due to lack of study subjects to recruit.",,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:51:36.169984,2024-10-16 23:51:36.169984,INDUSTRY,,,,,,,2022,0.0
NCT04897880,,2021-05-06,,,2024-09-02,2021-05-18,2021-05-24,ACTUAL,,,,,,,2024-09-02,2024-09-04,ACTUAL,2019-01-09,ACTUAL,2019-01-09,2024-09,2024-09-30,2024-05-08,ACTUAL,2024-05-08,2024-05-08,ACTUAL,2024-05-08,,INTERVENTIONAL,NORTH,,A Study of Panobinostat in Pediatric Patients With Solid Tumors Including MRT/ATRT,"A Phase II Study of Panobinostat in Pediatric, Adolescent and Young Adult Patients With Solid Tumors Including Osteosarcoma, Malignant Rhabdoid Tumor/Atypical Teratoid Rhabdoid Tumors and Neuroblastoma",TERMINATED,,PHASE2,25.0,ACTUAL,Australian & New Zealand Children's Haematology/Oncology Group,,3.0,,Drug supply,f,,,,t,t,f,,,,,,,,,,,2024-10-15 01:42:45.200039,2024-10-15 01:42:45.200039,OTHER,,,,,,,2024,0.0
NCT05035576,,2021-08-24,,,2022-04-26,2021-09-03,2021-09-05,ACTUAL,,,,,,,2022-04-26,2022-05-02,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2022-04,2022-04-30,2021-11-30,ACTUAL,2021-11-30,2021-11-30,ACTUAL,2021-11-30,,INTERVENTIONAL,,,A Study to Evaluate Change in Viral Load After OPN-019 in Adults With COVID-19,"A Randomized, Adaptive Design, Proof of Concept, Single Dose Study to Evaluate Change in Viral Load After OPN-019 in Adults With COVID-19",TERMINATED,,PHASE1,8.0,ACTUAL,Optinose US Inc.,,2.0,,Sponsor Decision,f,,,,f,f,f,,,,,,,,,,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,INDUSTRY,,,,,,,2021,0.0
NCT03199040,,2017-06-22,2023-11-18,,2024-04-25,2017-06-22,2017-06-26,ACTUAL,2023-12-12,2023-12-14,ACTUAL,,,,2024-04-25,2024-05-28,ACTUAL,2019-07-23,ACTUAL,2019-07-23,2024-04,2024-04-30,2023-05-01,ACTUAL,2023-05-01,2022-11-21,ACTUAL,2022-11-21,,INTERVENTIONAL,,,Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy,A Randomized Phase 1 Trial of Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy,TERMINATED,,PHASE1,18.0,ACTUAL,Washington University School of Medicine,,2.0,,Drugs/equipment unavailable and insufficient funding,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,OTHER,,,,,,,2023,0.0
NCT04933617,,2021-06-18,2024-05-16,,2024-06-13,2021-06-19,2021-06-22,ACTUAL,2024-06-13,2024-07-09,ACTUAL,,,,2024-06-13,2024-07-09,ACTUAL,2022-03-24,ACTUAL,2022-03-24,2024-06,2024-06-30,2023-11-30,ACTUAL,2023-11-30,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,,,Copanlisib With Dose-Adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas,Phase 1 Study of Copanlisib With Dose-adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas,TERMINATED,,PHASE1,8.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,The study was terminated early because copanlisib was removed from the market by the Food and Drug Administration (FDA) and the manufacturer.,f,,,,f,t,f,,,,,,Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.,,YES,All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. All large- scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).,2024-10-16 23:51:36.169984,2024-10-16 23:51:36.169984,NIH,,,,,,,2023,0.0
NCT04283526,,2020-02-21,,,2021-03-02,2020-02-21,2020-02-25,ACTUAL,,,,,,,2021-03-02,2021-03-04,ACTUAL,2020-11-30,ESTIMATED,2020-11-30,2021-03,2021-03-31,2024-04-11,ESTIMATED,2024-04-11,2024-04-11,ESTIMATED,2024-04-11,,INTERVENTIONAL,,,Study of Select Combinations in Adults With Myelofibrosis,"A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Combinations in Adult Patients With Myelofibrosis",WITHDRAWN,,PHASE1,0.0,ACTUAL,Novartis,,5.0,,This study was cancelled before enrolling any patients for business related reasons.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 23:51:36.169984,2024-10-16 23:51:36.169984,INDUSTRY,,,,,,,2024,0.0
NCT04525014,,2020-08-20,,,2024-07-30,2020-08-21,2020-08-24,ACTUAL,,,,,,,2024-07-30,2024-08-01,ACTUAL,2023-01-26,ACTUAL,2023-01-26,2024-07,2024-07-31,2024-07-29,ACTUAL,2024-07-29,2024-07-29,ACTUAL,2024-07-29,,INTERVENTIONAL,PIRATE,,RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors,A Phase 1 Trial of RRx-001 in Combination With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors,TERMINATED,,PHASE1,2.0,ACTUAL,"EpicentRx, Inc.",,1.0,,Low Enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:24:52.208295,2024-10-15 15:24:52.208295,INDUSTRY,,,,,,,2024,0.0
NCT03528564,,2018-04-09,,,2021-06-14,2018-05-04,2018-05-18,ACTUAL,,,,,,,2021-06-14,2021-06-18,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2021-06,2021-06-30,2021-05-31,ACTUAL,2021-05-31,2021-05-31,ACTUAL,2021-05-31,,INTERVENTIONAL,HOPE-Hb,,Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia,A Randomized Double-Blinded Phase II Study to Determine Treatment Protocol for Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia,TERMINATED,,PHASE2,4.0,ACTUAL,Unity Health Toronto,,2.0,,"The primary reasoning is that we were unable to demonstrate feasibility, prior to and because of the impact of COVID on our research programs.",f,,,,f,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 23:51:36.169984,2024-10-16 23:51:36.169984,OTHER,,,,,,,2021,0.0
NCT02033278,,2014-01-09,,,2020-09-16,2014-01-09,2014-01-10,ESTIMATED,,,,,,,2020-09-16,2020-09-18,ACTUAL,2014-01-06,ACTUAL,2014-01-06,2020-09,2020-09-30,2020-04-21,ACTUAL,2020-04-21,2018-10-19,ACTUAL,2018-10-19,,INTERVENTIONAL,,,Infusion Intracoronary of Mononuclear Autologous Adult no Expanded Stem Cells of Bone Marrow on Functional Recovery in Patients With Idiopathic Dilated Cardiomyopathy and Heart Failure.,"Multicenter Phase IIb Clinical Trial, Double-blind, Randomized, Controlled Placebo for to Assess the Efficacy of Intracoronary Infusion of Autologous Adult Stem Cells Mononuclear Marrow Unexpanded on Functional Recovery in Patients With Idiopathic Dilated Cardiomyopathy and Heart Failure.",TERMINATED,,PHASE2,27.0,ACTUAL,Andalusian Network for Design and Translation of Advanced Therapies,,2.0,,"Low recruitment rate, bibliographic evidence of lack of efficacy",f,,,,t,,,,,,,,,,,,,2024-10-16 23:51:36.169984,2024-10-16 23:51:36.169984,OTHER,,,,,,,2020,0.0
NCT02636803,,2015-12-14,,,2019-08-13,2015-12-21,2015-12-22,ESTIMATED,,,,,,,2019-08-13,2019-08-15,ACTUAL,2019-11,ESTIMATED,2019-11-30,2019-08,2019-08-31,2021-02,ESTIMATED,2021-02-28,2020-08,ESTIMATED,2020-08-31,,INTERVENTIONAL,,,Study of the Efficacy of Oxfendazole Compared to Albendazole in the Treatment of Trichuris Trichiura Infection in Adults,An Open Comparative Study of the Efficacy of Different Doses of Oxfendazole Compared to Single Dose Albendazole in the Treatment of Trichuris Trichiura Infection in Adults,WITHDRAWN,,PHASE2,0.0,ACTUAL,Johns Hopkins Bloomberg School of Public Health,,4.0,,not going to be conducted,f,,,,t,t,f,,,,,,,,,YES,posting to CT.gov and publication,2024-10-16 23:51:36.169984,2024-10-16 23:51:36.169984,OTHER,,,,,,,2021,0.0
NCT03683277,,2018-08-23,,,2023-06-01,2018-09-22,2018-09-25,ACTUAL,,,,,,,2023-06-01,2023-06-05,ACTUAL,2019-11-03,ACTUAL,2019-11-03,2023-06,2023-06-30,2023-02-10,ACTUAL,2023-02-10,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,IFM2014-01,,IPD in RRMM Characterized With Genomic Abnormalities of Adverse Prognostic,"Multicenter Open Label Phase 2 Single Arm Study of Ixazomib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Characterized With Genomic Abnormalities of Adverse Adverse Prognostic",TERMINATED,,PHASE2,26.0,ACTUAL,Intergroupe Francophone du Myelome,,1.0,,"Recruitment issue, 26 patients enrolled instead of 70 initially planned",f,,,,t,f,f,,,,,,,,,,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,NETWORK,,,,,,,2023,0.0
NCT05556265,,2022-09-23,,,2024-05-29,2022-09-23,2022-09-27,ACTUAL,,,,,,,2024-05-29,2024-05-31,ACTUAL,2022-11-08,ACTUAL,2022-11-08,2024-05,2024-05-31,2024-05-16,ACTUAL,2024-05-16,2024-01-06,ACTUAL,2024-01-06,,INTERVENTIONAL,,,A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata,"A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study to Evaluate Clinical Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants With Alopecia Areata",TERMINATED,,PHASE2,94.0,ACTUAL,Bristol-Myers Squibb,,3.0,,Business objectives have changed,f,,,,t,t,f,,,,,,See plan description,See plan description,https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html,YES,"BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html",2024-10-16 23:51:36.169984,2024-10-16 23:51:36.169984,INDUSTRY,,,,,,,2024,0.0
NCT03782532,,2018-12-05,,,2022-12-23,2018-12-18,2018-12-20,ACTUAL,,,,,,,2022-12-23,2022-12-28,ACTUAL,2019-01-25,ACTUAL,2019-01-25,2022-12,2022-12-31,2022-05-21,ACTUAL,2022-05-21,2022-05-21,ACTUAL,2022-05-21,,INTERVENTIONAL,,,Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma,"A Randomized, Double Blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma",COMPLETED,,PHASE3,486.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,f,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 23:51:36.169984,2024-10-16 23:51:36.169984,INDUSTRY,,,,,,,2022,1.0
NCT03163784,,2017-05-18,,,2018-11-13,2017-05-19,2017-05-23,ACTUAL,,,,,,,2018-11-13,2018-11-15,ACTUAL,2018-06,ESTIMATED,2018-06-30,2018-11,2018-11-30,2022-06,ESTIMATED,2022-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,SHIFT,,SHIFT: Studying HIV Immunology After Fecal Transplant,SHIFT: Studying HIV Immunology After Fecal Transplant,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Massachusetts General Hospital,,3.0,,The study closed because of shifting research priorities and interests.,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,OTHER,,,,,,,2022,0.0
NCT02941016,,2016-10-18,,,2020-10-12,2016-10-20,2016-10-21,ESTIMATED,,,,,,,2020-10-12,2020-10-14,ACTUAL,2016-10,,2016-10-31,2020-10,2020-10-31,2020-10-01,ACTUAL,2020-10-01,2020-10,ESTIMATED,2020-10-31,,INTERVENTIONAL,,,Vascular Inflammation and Cholesterol Lowering Therapy,Vascular Inflammation and Cholesterol Lowering Therapy,WITHDRAWN,,PHASE4,0.0,ACTUAL,"Rigshospitalet, Denmark",,1.0,,Logistic reasons,f,,,,,,,,,,,,,,,,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,OTHER,,,,,,,2020,0.0
NCT04353284,,2020-04-16,2022-03-02,,2022-03-22,2020-04-17,2020-04-20,ACTUAL,2022-03-22,2022-03-24,ACTUAL,,,,2022-03-22,2022-03-24,ACTUAL,2020-06-09,ACTUAL,2020-06-09,2022-03,2022-03-31,2021-04-22,ACTUAL,2021-04-22,2021-03-03,ACTUAL,2021-03-03,,INTERVENTIONAL,,,Camostat Mesylate in COVID-19 Outpatients,"The Effect of Camostat Mesylate on COVID-19 Infection in Ambulatory Patients: An Investigator-Initiated Randomized, Placebo-Controlled, Phase IIa Trial",COMPLETED,,PHASE2,70.0,ACTUAL,Yale University,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,OTHER,,,,,,,2021,1.0
NCT04234867,,2020-01-16,,,2023-06-02,2020-01-16,2020-01-21,ACTUAL,,,,,,,2023-06-02,2023-06-05,ACTUAL,2022-05-18,ACTUAL,2022-05-18,2023-06,2023-06-30,2022-08-26,ACTUAL,2022-08-26,2022-08-26,ACTUAL,2022-08-26,,INTERVENTIONAL,Dapa-Stress,,Study to Explore the Effect of Dapagliflozin and Stress in Adolescent and Adult Subjects With Type 1 Diabetes (T1D),"A Randomized, Double-Blinded, Placebo-controlled, Single-center Phase 1 Pilot Study to Explore the Effect of DAPAglifozin and Stress ( i.v. ACTH) on the Development of DKA After Insulin Withdrawal in Adolescent and Adult Subjects With T1D",TERMINATED,,PHASE1,2.0,ACTUAL,Kinderkrankenhaus auf der Bult,,4.0,,slow recruitment,f,,,,t,f,f,,,,,,,,,,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,OTHER,,,,,,,2022,0.0
NCT02781610,,2016-05-12,2021-03-11,,2021-04-28,2016-05-23,2016-05-24,ESTIMATED,2021-03-11,2021-04-08,ACTUAL,,,,2021-04-28,2021-05-19,ACTUAL,2016-06,,2016-06-30,2021-04,2021-04-30,2020-03-06,ACTUAL,2020-03-06,2020-03-06,ACTUAL,2020-03-06,,INTERVENTIONAL,STOP2,"Analysis for the ERR arms (ERR-10, ERR-14) was done on the per-protocol (PP) population. Analysis for the NERR arms (NERR-14, NERR-21) was done on the intent-to-treat (ITT) population. Caution: Analysis was not done on the combined total of all four treatment duration arms. Interpreting the total column is inappropriate for this study design.",Standardized Treatment of Pulmonary Exacerbations II,Standardized Treatment of Pulmonary Exacerbations II (STOP2),COMPLETED,,PHASE4,982.0,ACTUAL,Seattle Children's Hospital,Analysis was not done on the combined total of all four treatment duration arms. Interpreting the total column within demographics is inappropriate for this study design.,4.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,OTHER,,,,,,,2020,1.0
NCT04202679,,2019-12-16,2022-08-29,,2022-11-21,2019-12-16,2019-12-17,ACTUAL,2022-08-29,2022-09-28,ACTUAL,,,,2022-11-21,2022-12-21,ACTUAL,2020-01-16,ACTUAL,2020-01-16,2022-11,2022-11-30,2021-11-22,ACTUAL,2021-11-22,2021-08-30,ACTUAL,2021-08-30,,INTERVENTIONAL,,Analysis was performed on randomized population.,"Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)","A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable",COMPLETED,,PHASE3,160.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,INDUSTRY,,,,,,,2021,1.0
NCT03913702,,2019-04-10,,,2023-03-03,2019-04-10,2019-04-12,ACTUAL,,,,,,,2023-03-03,2023-03-07,ACTUAL,2019-09-09,ACTUAL,2019-09-09,2023-03,2023-03-31,2022-11-02,ACTUAL,2022-11-02,2022-11-02,ACTUAL,2022-11-02,,INTERVENTIONAL,,,Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement,Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial,TERMINATED,,PHASE2,1.0,ACTUAL,"The University of Texas Medical Branch, Galveston",,2.0,,Inadequate patient enrollment,f,,,,t,t,f,,,f,,,20 weeks from the last patient enrollment,"At the end of this investigation, all results will be tabulated and submitted to clinicaltrials.gov to report.",,YES,"At the end of this investigation, IPD-related results will be tabulated and submitted to clinicaltrials.gov to report. This would help evaluate the effects and safety of interventions administered.",2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,OTHER,,,,,,,2022,0.0
NCT05198843,,2022-01-19,2024-04-24,,2024-08-12,2022-01-19,2022-01-20,ACTUAL,2024-08-12,2024-09-04,ACTUAL,,,,2024-08-12,2024-09-04,ACTUAL,2022-11-08,ACTUAL,2022-11-08,2024-08,2024-08-31,2023-12-20,ACTUAL,2023-12-20,2023-12-19,ACTUAL,2023-12-19,,INTERVENTIONAL,,,Testing an Omega-3 Fatty Acid-Based Anti-Cancer Therapy for Patients With Triple-Negative Inflammatory Breast Cancer That Has Spread to Other Parts of the Body,Phase Ib/II Study of EPA-Based EphA2 Targeted Therapy for Patients With Metastatic Triple-Negative Inflammatory Breast Cancer,TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,National Cancer Institute (NCI),,1.0,,Other - Poor accrual,f,,,,f,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.",2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,NIH,,,,,,,2023,0.0
NCT03943823,,2019-05-07,2023-02-06,,2023-03-06,2019-05-07,2019-05-09,ACTUAL,2023-02-06,2023-03-01,ACTUAL,,,,2023-03-06,2023-03-08,ACTUAL,2019-05-07,ACTUAL,2019-05-07,2023-03,2023-03-31,2021-04-08,ACTUAL,2021-04-08,2021-03-08,ACTUAL,2021-03-08,,INTERVENTIONAL,,,Postmenopausal Pessary Users: Estrogen Versus Trimosan,Postmenopausal Pessary Users: Estrogen Versus Trimosan,TERMINATED,,PHASE4,4.0,ACTUAL,"The University of Texas Health Science Center, Houston","Early termination as a result of discontinuation of in-person research due to COVID-19 pandemic, as well as unavailability of study drug.",2.0,,Difficulties in recruiting and retaining patients due to the COVID pandemic; lack of availability of study drug trimosan; lack of study personnel,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 23:51:36.169984,2024-10-16 23:51:36.169984,OTHER,,,,,,,2021,0.0
NCT04671355,,2020-10-28,,,2022-01-19,2020-12-15,2020-12-17,ACTUAL,,,,,,,2022-01-19,2022-02-03,ACTUAL,2021-10-04,ESTIMATED,2021-10-04,2022-01,2022-01-31,2022-02-18,ESTIMATED,2022-02-18,2021-12-22,ESTIMATED,2021-12-22,,INTERVENTIONAL,,,TRIMBOW® and RELVAR® on Lung Stiffness Reduction Assessed Through Forced Oscillation Technique in Patients With COPD,"A Phase IV, Open Label, Multicentre, Randomised, 2-way Cross-over Exploratory Clinical Trial Comparing TRIMBOW® pMDI and RELVAR® ELLIPTA® DPI on Lung Stiffness Reduction Assessed Through Area Under the Reactance Curve (AX) in COPD.",WITHDRAWN,,PHASE4,0.0,ACTUAL,Chiesi Farmaceutici S.p.A.,,2.0,,Continuing delays due to COVID-19 pandemic,f,,,,f,f,f,,,,,,,Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.,https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/,YES,"Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.~Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.",2024-10-16 23:51:36.169984,2024-10-16 23:51:36.169984,INDUSTRY,,,,,,,2022,0.0
NCT04680975,,2020-12-11,2023-05-08,,2023-05-08,2020-12-22,2020-12-23,ACTUAL,2023-05-08,2023-06-05,ACTUAL,,,,2023-05-08,2023-06-05,ACTUAL,2021-03-03,ACTUAL,2021-03-03,2023-05,2023-05-31,2022-12-19,ACTUAL,2022-12-19,2022-05-10,ACTUAL,2022-05-10,,INTERVENTIONAL,dcSSC,Analysis was performed on modified intent to treat (mITT) population which included all participants who received at least 1 dose of belumosudil 200 mg.,Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis,"A Phase 2, Open-label Multicenter Study to Evaluate the Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis (dcSSc)",TERMINATED,,PHASE2,10.0,ACTUAL,Sanofi,"Due to slow enrollment and strategic consideration, Sponsor decided to terminate the study and the termination was not driven by any safety concerns.",1.0,,Sponsor decision due to slow enrollment and strategic consideration; not driven by any safety concerns.,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.",2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,INDUSTRY,,,,,,,2022,0.0
NCT04836832,,2021-03-09,,,2022-06-02,2021-04-06,2021-04-08,ACTUAL,,,,,,,2022-06-02,2022-06-07,ACTUAL,2022-07-01,ESTIMATED,2022-07-01,2022-06,2022-06-30,2024-12-31,ESTIMATED,2024-12-31,2023-12-31,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Acalabrutinib and Duvelisib for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin Lymphoma,A Phase Ib/II Study of Duvelisib and Acalabrutinib in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (DUAL Trial),WITHDRAWN,,PHASE1,0.0,ACTUAL,Ohio State University Comprehensive Cancer Center,,1.0,,PI decision,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2024,0.0
NCT05438758,,2022-06-24,,,2022-11-09,2022-06-24,2022-06-30,ACTUAL,,,,,,,2022-11-09,2022-11-15,ACTUAL,2023-01-15,ESTIMATED,2023-01-15,2022-11,2022-11-30,2024-03-01,ESTIMATED,2024-03-01,2024-02-01,ESTIMATED,2024-02-01,,INTERVENTIONAL,ZYL-730-02,,Repeated Intranasal Esketamine Plus Almond Therapy in Participants With Treatment Resistant Depressive Disorder - 3 Month Extension Study,"Phase 2, Controlled, Single-Blind, 3-Month Extension Study For Participants Originally Diagnosed With Treatment Resistant Major Depressive Disorder (TRD) Who Complete Study ZYL-730-01 With, or Without, Almond Therapy",WITHDRAWN,,PHASE2,0.0,ACTUAL,Zylorion Health,,2.0,,Withdrawn by Sponsor,f,,,,f,f,f,,,,,,Throughout the study,Involved in data collection,,YES,IPD will be available to other members of the study team including Dr. Craig Buchholz,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,INDUSTRY,,,,,,,2024,0.0
NCT04234516,,2020-01-16,,,2021-06-14,2020-01-16,2020-01-21,ACTUAL,,,,,,,2021-06-14,2021-06-18,ACTUAL,2020-01-20,ACTUAL,2020-01-20,2021-06,2021-06-30,2021-06-10,ACTUAL,2021-06-10,2021-06-10,ACTUAL,2021-06-10,,INTERVENTIONAL,,,Anti-suicidal Effects of Buprenorphine in Opioid Use Disorder,Functional Brain Mechanisms Underlying the Anti-suicidal Effects of Buprenorphine in Opioid Use Disorder,WITHDRAWN,,PHASE4,0.0,ACTUAL,New York State Psychiatric Institute,,2.0,,PI leaving the institute,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2021,0.0
NCT03910439,,2019-04-09,2021-03-03,,2021-04-19,2019-04-09,2019-04-10,ACTUAL,2021-03-30,2021-04-20,ACTUAL,,,,2021-04-19,2021-05-12,ACTUAL,2019-10-17,ACTUAL,2019-10-17,2021-04,2021-04-30,2020-11-04,ACTUAL,2020-11-04,2020-11-04,ACTUAL,2020-11-04,,INTERVENTIONAL,,,Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma,A Phase II Pilot Study of Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma,TERMINATED,,PHASE2,4.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,Slow/Insufficient accrual/COVID-19 pandemic,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,NIH,,,,,,,2020,0.0
NCT02198209,,2014-07-21,,,2019-09-26,2014-07-22,2014-07-23,ESTIMATED,,,,,,,2019-09-26,2019-09-30,ACTUAL,2019-12,ESTIMATED,2019-12-31,2019-09,2019-09-30,2020-12,ESTIMATED,2020-12-31,2020-07,ESTIMATED,2020-07-31,,INTERVENTIONAL,,,Liraglutide Actions on the Liver: Effects on Glucose Phosphorylation,Liraglutide Actions on the Liver: Effects on Glucose Phosphorylation,WITHDRAWN,,PHASE4,0.0,ACTUAL,Cedars-Sinai Medical Center,,1.0,,Investigator decided not to move forward with study prior to study start date,f,,,,f,t,f,,,,,,,,,,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2020,0.0
NCT04206605,,2019-12-18,2023-10-18,,2023-12-06,2019-12-18,2019-12-20,ACTUAL,2023-12-06,2023-12-27,ACTUAL,,,,2023-12-06,2023-12-27,ACTUAL,2020-05-04,ACTUAL,2020-05-04,2023-12,2023-12-31,2022-10-20,ACTUAL,2022-10-20,2022-10-20,ACTUAL,2022-10-20,,INTERVENTIONAL,,Safety analysis set (SAS) included all participants who received any exposure to the investigational product.,A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH),"A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)",COMPLETED,,PHASE3,77.0,ACTUAL,Takeda,,2.0,,,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,INDUSTRY,,,,,,,2022,1.0
NCT04713202,,2021-01-14,,,2023-02-08,2021-01-14,2021-01-19,ACTUAL,,,,,,,2023-02-08,2023-02-10,ACTUAL,2021-03-03,ACTUAL,2021-03-03,2023-02,2023-02-28,2024-02,ESTIMATED,2024-02-29,2023-02,ESTIMATED,2023-02-28,,INTERVENTIONAL,NET-PACS,,Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl,Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl (NET-PACS Trial) Big Ten Cancer Research Consortium BTCRC-GI19-400,WITHDRAWN,,PHASE2,0.0,ACTUAL,Big Ten Cancer Research Consortium,,2.0,,Funder decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,OTHER,,,,,,,2024,0.0
NCT04622072,,2020-10-13,,,2023-02-15,2020-11-03,2020-11-09,ACTUAL,,,,,,,2023-02-15,2023-02-17,ACTUAL,2020-11-02,ACTUAL,2020-11-02,2021-05,2021-05-31,2022-04-27,ACTUAL,2022-04-27,2021-05-20,ACTUAL,2021-05-20,,INTERVENTIONAL,,,XZP-5809-TT1 Tablets in Patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer,"A Single-arm, Open, Multi-center Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Effectiveness of XZP-5809-TT1 Tablets in Patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Have Progressed After Treatment With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI).",TERMINATED,,PHASE1,21.0,ACTUAL,Sihuan Pharmaceutical Holdings Group Ltd.,,1.0,,Strategic considerations,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,INDUSTRY,,,,,,,2022,0.0
NCT04072887,,2019-08-07,2023-01-30,2022-07-27,2023-04-06,2019-08-27,2019-08-28,ACTUAL,2023-04-06,2023-04-28,ACTUAL,,2023-04-28,ACTUAL,2023-04-06,2023-04-28,ACTUAL,2019-09-12,ACTUAL,2019-09-12,2023-04,2023-04-30,2022-02-01,ACTUAL,2022-02-01,2021-10-08,ACTUAL,2021-10-08,,INTERVENTIONAL,,,Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients,"A 24-week Multi-center, Double-blind, Placebo Controlled Dose-range Finding Study to Investigate the Efficacy and Safety of Oral QBW251 in COPD Patients on Triple Inhaled Therapy (LABA / LAMA / ICS)",COMPLETED,,PHASE2,974.0,ACTUAL,Novartis,,6.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,INDUSTRY,,,,,,,2022,1.0
NCT04408040,,2020-05-15,2021-11-23,,2022-10-19,2020-05-27,2020-05-29,ACTUAL,2022-10-19,2022-11-14,ACTUAL,,,,2022-10-19,2022-11-14,ACTUAL,2020-07-14,ACTUAL,2020-07-14,2022-10,2022-10-31,2021-09-14,ACTUAL,2021-09-14,2021-09-14,ACTUAL,2021-09-14,,INTERVENTIONAL,,No critical patients were consented for this study,Use of Convalescent Plasma for COVID-19,"Use of Convalescent Plasma Collected From Donors Recovered From COVID-19 Virus Disease for Transfusion, as an Empirical and Preemptive Treatment During Viral Pandemic Outbreak",TERMINATED,,PHASE2,8.0,ACTUAL,"Northside Hospital, Inc.",,4.0,,New information regarding use of plasma in covid + patients,f,,,,,t,f,,,,,,,,,,,2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,OTHER,,,,,,,2021,0.0
NCT04240158,,2020-01-21,,,2024-08-13,2020-01-21,2020-01-27,ACTUAL,,,,,,,2024-08-13,2024-08-16,ACTUAL,2020-01-06,ACTUAL,2020-01-06,2024-08,2024-08-31,2020-05-22,ACTUAL,2020-05-22,2020-05-22,ACTUAL,2020-05-22,,INTERVENTIONAL,,,IW-6463 Safety Study in Healthy Elderly Subjects,"Evaluating the Safety, Tolerability, and Pharmacodynamic Properties of IW-6463 in Healthy Elderly Subjects",TERMINATED,,PHASE1,24.0,ACTUAL,Tisento Therapeutics,,2.0,,Some subjects could not complete the second crossover period due to COVID-19-related site closure. The study was closed to allow analysis of all collected data.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,INDUSTRY,,,,,,,2020,0.0
NCT04702997,,2021-01-07,2022-11-04,,2024-02-01,2021-01-07,2021-01-11,ACTUAL,2022-11-04,2022-12-01,ACTUAL,,,,2024-02-01,2024-02-05,ACTUAL,2021-02-09,ACTUAL,2021-02-09,2024-02,2024-02-29,2021-11-23,ACTUAL,2021-11-23,2021-10-20,ACTUAL,2021-10-20,,INTERVENTIONAL,MERLIN,,A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN),"A Phase 2 Trial to Evaluate Safety, Tolerability, and Efficacy of Bardoxolone Methyl in Patients With Chronic Kidney Disease at Risk of Rapid Progression",COMPLETED,,PHASE2,81.0,ACTUAL,Biogen,,2.0,,,f,,,,f,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,INDUSTRY,,,,,,,2021,1.0
NCT03749109,,2018-11-19,2022-06-21,,2023-08-04,2018-11-19,2018-11-21,ACTUAL,2022-08-15,2022-09-07,ACTUAL,,,,2023-08-04,2023-08-07,ACTUAL,2019-08-19,ACTUAL,2019-08-19,2023-08,2023-08-31,2021-07-18,ACTUAL,2021-07-18,2021-06-21,ACTUAL,2021-06-21,,INTERVENTIONAL,QLARITY,,Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis,"A Randomised, Double-blind, Placebo-controlled, Proof-of-mechanism Phase 2 Trial Investigating the Effect of Quinagolide Extended-release Vaginal Ring on Reduction of Lesions Assessed by High-resolution Magnetic Resonance Imaging in Women With Endometrioma, Deep Infiltrating Endometriosis, and/or Adenomyosis",COMPLETED,,PHASE2,67.0,ACTUAL,Ferring Pharmaceuticals,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,INDUSTRY,,,,,,,2021,1.0
NCT04341441,,2020-04-07,2022-02-28,,2022-06-15,2020-04-07,2020-04-10,ACTUAL,2022-06-15,2022-06-21,ACTUAL,,,,2022-06-15,2022-06-21,ACTUAL,2020-04-07,ACTUAL,2020-04-07,2022-06,2022-06-30,2020-12-15,ACTUAL,2020-12-15,2020-12-15,ACTUAL,2020-12-15,,INTERVENTIONAL,WHIP COVID-19,,Will Hydroxychloroquine Impede or Prevent COVID-19,Will Hydroxychloroquine Impede or Prevent COVID-19: WHIP COVID-19 Study,TERMINATED,,PHASE3,624.0,ACTUAL,Henry Ford Health System,"Study has been terminated. Interim analysis did not reveal any safety concerns by the DSMB with hydroxychloroquine treatment, but unblinded data did not provide support to continue due to low numbers of events. Event rate did not meet projected magnitude; given low recruitment potential, it is unlikely that a positive result will occur.",4.0,,"Interim analysis did not reveal any safety concerns by the DSMB, but unblinded data did not provide support to continue. Event rate did not meet projected magnitude; given low recruitment potential, it is unlikely that a positive result will occur.",f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,OTHER,,,,,,,2020,0.0
NCT03770091,,2018-12-06,2021-06-12,,2021-07-13,2018-12-06,2018-12-10,ACTUAL,2021-07-13,2021-07-14,ACTUAL,,,,2021-07-13,2021-07-14,ACTUAL,2018-12-21,ACTUAL,2018-12-21,2021-07,2021-07-31,2020-08-01,ACTUAL,2020-08-01,2020-07-30,ACTUAL,2020-07-30,,INTERVENTIONAL,,,Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis,Impact of Theraworx Foam on Pain and Motion and Patient-Reported Outcomes in Thumb Arthritis,COMPLETED,,PHASE3,40.0,ACTUAL,University of Pittsburgh,,3.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,OTHER,,,,,,,2020,1.0
NCT01583842,,2012-04-17,,,2021-05-12,2012-04-23,2012-04-24,ESTIMATED,,,,,,,2021-05-12,2021-05-14,ACTUAL,2013-04-09,ACTUAL,2013-04-09,2021-05,2021-05-31,2021-02-25,ACTUAL,2021-02-25,2021-02-25,ACTUAL,2021-02-25,,INTERVENTIONAL,,,124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study,124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study,TERMINATED,,EARLY_PHASE1,10.0,ACTUAL,"University of California, San Francisco",,3.0,,Funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,OTHER,,,,,,,2021,0.0
NCT03419130,,2017-12-08,,,2018-12-05,2018-01-25,2018-02-01,ACTUAL,,,,,,,2018-12-05,2018-12-07,ACTUAL,2018-07-18,ESTIMATED,2018-07-18,2018-12,2018-12-31,2022-12-31,ESTIMATED,2022-12-31,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Radiation Therapy and Pembrolizumab in Treating Patients With Localized Urothelial Bladder Cancer,A Phase II Study of Radiation Therapy and Pembrolizumab in Patients With Localized Urothelial Bladder Cancer That Are Ineligible or Refusing Chemotherapy,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, San Francisco",,2.0,,Study withdrawn prior to patient enrollment,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,OTHER,,,,,,,2022,0.0
NCT04605926,,2020-10-21,,,2021-01-25,2020-10-27,2020-10-28,ACTUAL,,,,,,,2021-01-25,2021-01-27,ACTUAL,2020-11,ESTIMATED,2020-11-30,2021-01,2021-01-31,2021-06,ESTIMATED,2021-06-30,2021-04,ESTIMATED,2021-04-30,,INTERVENTIONAL,EQUINOX,,A Study to Evaluate the Efficacy and Safety of Itolizumab in Subjects Hospitalized With COVID-19,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Itolizumab in Subjects Hospitalized With COVID-19",WITHDRAWN,,PHASE3,0.0,ACTUAL,Equillium,,2.0,,Sponsor has currently elected to withhold study initiation,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,INDUSTRY,,,,,,,2021,0.0
NCT03417882,,2017-11-14,,,2023-08-05,2018-01-30,2018-01-31,ACTUAL,,,,,,,2023-08-05,2023-08-08,ACTUAL,2019-01-03,ACTUAL,2019-01-03,2023-08,2023-08-31,2022-12-05,ACTUAL,2022-12-05,2022-12-05,ACTUAL,2022-12-05,,INTERVENTIONAL,,,GRN-1201 With Pembrolizumab in Subjects With Metastatic PD-L1+ NSCLC,"A Pilot, Open-Label, Multi-Center, Multi-Dose Study of GRN-1201 Added to Pembrolizumab in Subjects With Non-Small Cell Lung Cancer With High PD-L1 Expression",TERMINATED,,PHASE2,20.0,ACTUAL,BrightPath Biotherapeutics,,1.0,,Recruitment rate too slow,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 15:24:52.208295,2024-10-15 15:24:52.208295,INDUSTRY,,,,,,,2022,0.0
NCT04360876,,2020-04-22,,,2020-10-26,2020-04-22,2020-04-24,ACTUAL,,,,,,,2020-10-26,2020-10-28,ACTUAL,2020-09-01,ESTIMATED,2020-09-01,2020-10,2020-10-31,2021-01-30,ESTIMATED,2021-01-30,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Targeted Steroids for ARDS Due to COVID-19 Pneumonia: A Pilot Randomized Clinical Trial,Targeted Steroids for ARDS Due to COVID-19 Pneumonia: A Pilot Randomized Clinical Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of Colorado, Denver",,2.0,,Funding not received,f,,,,t,f,f,,,f,,,,,,NO,No Plan,2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,OTHER,,,,,,,2021,0.0
NCT04248465,,2020-01-27,2022-09-22,,2022-12-15,2020-01-29,2020-01-30,ACTUAL,2022-12-15,2023-01-10,ACTUAL,,,,2022-12-15,2023-01-10,ACTUAL,2020-03-30,ACTUAL,2020-03-30,2022-12,2022-12-31,2021-10-17,ACTUAL,2021-10-17,2021-10-17,ACTUAL,2021-10-17,,INTERVENTIONAL,,Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug grouped by randomized treatment group.,An Efficacy and Safety Study of Ravulizumab in ALS Participants,"A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS)",TERMINATED,,PHASE3,382.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",The IDMC recommended the study be discontinued due to lack of efficacy with ravulizumab.,2.0,,The IDMC recommended the study be discontinued due to lack of efficacy with ravulizumab.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 15:24:52.208295,2024-10-15 15:24:52.208295,INDUSTRY,,,,,,,2021,0.0
NCT04260607,,2020-02-05,,,2023-10-13,2020-02-05,2020-02-07,ACTUAL,,,,,,,2023-10-13,2023-10-16,ACTUAL,2020-01-14,ACTUAL,2020-01-14,2023-10,2023-10-31,2022-02-16,ACTUAL,2022-02-16,2021-04-24,ACTUAL,2021-04-24,,INTERVENTIONAL,,,Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department,Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department,TERMINATED,,PHASE3,2.0,ACTUAL,Naval Medical Center Camp Lejeune,,2.0,,As a busy MTF we were unable to retain a health care provider with the appropriate expertise to buy-in to this study once the initiating PI left military service.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,FED,,,,,,,2022,0.0
NCT04375514,,2020-04-30,,,2022-10-20,2020-05-04,2020-05-05,ACTUAL,,,,,,,2022-10-20,2022-10-24,ACTUAL,2020-08-10,ACTUAL,2020-08-10,2022-10,2022-10-31,2021-09-03,ACTUAL,2021-09-03,2021-09-03,ACTUAL,2021-09-03,,INTERVENTIONAL,,,Study of ARO-ENaC in Healthy Volunteers and in Patients With Cystic Fibrosis,"A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetic Effects of ARO-ENaC in Normal Healthy Volunteers and Safety, Tolerability and Efficacy in Patients With Cystic Fibrosis",TERMINATED,,PHASE1,43.0,ACTUAL,Arrowhead Pharmaceuticals,,2.0,,Business decision,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,INDUSTRY,,,,,,,2021,0.0
NCT04672876,,2020-09-29,,,2021-12-03,2020-12-15,2020-12-17,ACTUAL,,,,,,,2021-12-03,2021-12-17,ACTUAL,2022-01,ESTIMATED,2022-01-31,2021-12,2021-12-31,2023-10-01,ESTIMATED,2023-10-01,2022-10-01,ESTIMATED,2022-10-01,,INTERVENTIONAL,,,Telotristat Ethyl for Reducing Intraoperative Carcinoid Crisis in Patients With Neuroendocrine Tumors,Telotristat Ethyl for Reducing the Incidence of Intraoperative Carcinoid Crisis in Patients With Small Bowel Neuroendocrine Tumors,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Chicago,,1.0,,Trial funding no longer available.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,OTHER,,,,,,,2023,0.0
NCT02203773,,2014-07-10,,,2023-05-12,2014-07-28,2014-07-30,ESTIMATED,,,,,,,2023-05-12,2023-05-16,ACTUAL,2014-10-06,ACTUAL,2014-10-06,2023-05,2023-05-31,2022-06-16,ACTUAL,2022-06-16,2022-06-16,ACTUAL,2022-06-16,,INTERVENTIONAL,,,Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML),A Phase 1b Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine in Treatment-Naive Subjects With Acute Myelogenous Leukemia Who Are Greater Than or Equal to 60 Years of Age and Who Are Not Eligible for Standard Induction Therapy,TERMINATED,,PHASE1,212.0,ACTUAL,AbbVie,,3.0,,Strategic considerations,t,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,INDUSTRY,,NCT03123029,AVAILABLE,,,,2022,0.0
NCT05041972,,2021-09-03,,,2022-09-09,2021-09-10,2021-09-13,ACTUAL,,,,,,,2022-09-09,2022-09-13,ACTUAL,2021-11-05,ACTUAL,2021-11-05,2022-04,2022-04-30,2022-04-20,ACTUAL,2022-04-20,2022-04-20,ACTUAL,2022-04-20,,INTERVENTIONAL,,,ARX788 in Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors (ACE-Pan Tumor-02),A Global Phase 2 Study to Evaluate the Efficacy and Safety of ARX788 for Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Ambrx, Inc.",,6.0,,Business strategy change,f,,,,f,t,f,,,,,,,,,NO,De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available after the studies for which the medicine and indication have received marketing approval in European Union (EU) and United States (US) or regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.,2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,INDUSTRY,,,,,,,2022,0.0
NCT06097273,,2023-10-18,,,2024-06-20,2023-10-18,2023-10-24,ACTUAL,,,,,,,2024-06-20,2024-06-24,ACTUAL,2023-10-19,ACTUAL,2023-10-19,2024-06,2024-06-30,2024-05-28,ACTUAL,2024-05-28,2024-05-28,ACTUAL,2024-05-28,,INTERVENTIONAL,,,"A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age","A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age",COMPLETED,,PHASE3,8075.0,ACTUAL,"ModernaTX, Inc.",,4.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,INDUSTRY,,,,,,,2024,1.0
NCT03540225,,2018-05-07,,,2021-01-26,2018-05-27,2018-05-30,ACTUAL,,,,,,,2021-01-26,2021-01-28,ACTUAL,2020-04,ESTIMATED,2020-04-30,2021-01,2021-01-31,2022-12,ESTIMATED,2022-12-31,2022-04,ESTIMATED,2022-04-30,,INTERVENTIONAL,POPPET,,Vaginal Progesterone for the Prevention of Preterm Birth in Twins,"Vaginal Progesterone for the Prevention of Preterm Birth in Twins: A Pilot Randomised, Factorial Designed Trial (POPPET)",WITHDRAWN,,PHASE3,0.0,ACTUAL,Chinese University of Hong Kong,,4.0,,Fail to sort out the logistics of study drugs due to funding problems,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,OTHER,,,,,,,2022,0.0
NCT03985293,,2019-06-11,2022-06-02,,2022-06-02,2019-06-11,2019-06-13,ACTUAL,2022-06-02,2022-06-30,ACTUAL,,,,2022-06-02,2022-06-30,ACTUAL,2019-10-15,ACTUAL,2019-10-15,2022-06,2022-06-30,2021-07-07,ACTUAL,2021-07-07,2021-06-08,ACTUAL,2021-06-08,,INTERVENTIONAL,,"A total of 412 participants were assigned to treatment, 411 of whom were treated; 1 participant randomized to the PF-06882961 120 mg BID group was not treated.",A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus,"A 16-WEEK, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TWICE DAILY PF-06882961 ADMINISTRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED ON METFORMIN OR DIET AND EXERCISE",COMPLETED,,PHASE2,412.0,ACTUAL,Pfizer,,6.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,INDUSTRY,,,,,,,2021,1.0
NCT03905538,,2019-03-08,,,2024-02-27,2019-04-03,2019-04-05,ACTUAL,,,,,,,2024-02-27,2024-03-01,ACTUAL,2019-08-13,ACTUAL,2019-08-13,2024-02,2024-02-29,2024-12,ESTIMATED,2024-12-31,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Evaluation of [18F]FLT PET/CT as an Early Predictor of Outcome in Pediatric Solid Tumors,Evaluation of [18F]FLT PET/CT as an Early Predictor of Outcome in Pediatric Solid Tumors,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Texas Southwestern Medical Center,,1.0,,Lack of accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,OTHER,,,,,,,2024,0.0
NCT03976076,,2019-05-31,2022-12-10,,2024-08-21,2019-06-04,2019-06-05,ACTUAL,2023-01-23,2023-02-16,ACTUAL,,,,2024-08-21,2024-08-22,ACTUAL,2020-04-15,ACTUAL,2020-04-15,2024-08,2024-08-31,2021-12-10,ACTUAL,2021-12-10,2021-12-10,ACTUAL,2021-12-10,,INTERVENTIONAL,,,A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients,"A Phase 2 Study to Assess the Safety, Tolerability, Exploratory Efficacy, and Pharmacokinetics of Orally Administered JBPOS0101 for Refractory Infantile Spasms Patients",TERMINATED,,PHASE2,16.0,ACTUAL,"Bio-Pharm Solutions Co., Ltd.",No limitations reported for the study.,1.0,,Difficulty with patient recruitment due to COVID-19,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,INDUSTRY,,,,,,,2021,0.0
NCT04748848,,2021-02-02,,,2023-03-01,2021-02-09,2021-02-10,ACTUAL,,,,,,,2023-03-01,2023-03-02,ACTUAL,2021-10-14,ACTUAL,2021-10-14,2023-02,2023-02-28,2022-03-09,ACTUAL,2022-03-09,2022-03-09,ACTUAL,2022-03-09,,INTERVENTIONAL,,,"A Safety, Tolerability and Preliminary Efficacy Study of CC-90011 in Combination With Venetoclax and Azacitidine in R/R Acute Myeloid Leukemia and Treatment-naïve Participants Not Eligible for Intensive Therapy","A Phase 1/2, Open-label, Multicenter Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CC-90011 in Combination With Venetoclax and Azacitidine in R/R Acute Myeloid Leukemia (AML) and Treatment-naïve Subjects With AML Who Are Not Eligible for Intensive Induction Chemotherapy",TERMINATED,,PHASE1,1.0,ACTUAL,Celgene,,3.0,,Business objectives have changed.,f,,,,f,t,f,,,,,,See Plan Description,See Plan Description,https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,INDUSTRY,,,,,,,2022,0.0
NCT04344535,,2020-04-10,2021-09-20,,2021-12-02,2020-04-13,2020-04-14,ACTUAL,2021-12-02,2021-12-06,ACTUAL,,,,2021-12-02,2021-12-06,ACTUAL,2020-04-08,ACTUAL,2020-04-08,2021-12,2021-12-31,2021-02-01,ACTUAL,2021-02-01,2021-01-01,ACTUAL,2021-01-01,,INTERVENTIONAL,,,Convalescent Plasma vs. Standard Plasma for COVID-19,Convalescent Plasma to Reduce Complications Associated With COVID-19 Infection: A Randomized Trial Comparing the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma vs. Standard Plasma in Hospitalized Patients With COVID- 19 Infection,TERMINATED,,PHASE1/PHASE2,82.0,ACTUAL,Stony Brook University,,2.0,,Insufficient eligible and consenting patients,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,OTHER,,,,,,,2021,0.0
NCT02968680,,2016-08-02,,,2020-03-26,2016-11-16,2016-11-18,ESTIMATED,,,,,,,2020-03-26,2020-03-30,ACTUAL,2017-04-26,ACTUAL,2017-04-26,2020-03,2020-03-31,2020-01-09,ACTUAL,2020-01-09,2019-06-28,ACTUAL,2019-06-28,,INTERVENTIONAL,,,Sonazoid-Enhanced Ultrasound in Detecting Sentinel Lymph Node in Patients With Cutaneous Melanoma,Pilot Translational Study of Sonazoid-Enhanced Ultrasonography for Sentinel Lymph Node Mapping in Cutaneous Melanoma,TERMINATED,,PHASE1,5.0,ACTUAL,University of Southern California,,1.0,,Insufficient accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,OTHER,,,,,,,2020,0.0
NCT04148742,,2019-10-28,,,2021-06-10,2019-10-30,2019-11-01,ACTUAL,,,,,,,2021-06-10,2021-06-11,ACTUAL,2021-08,ESTIMATED,2021-08-31,2020-11,2020-11-30,2023-07,ESTIMATED,2023-07-31,2023-07,ESTIMATED,2023-07-31,,INTERVENTIONAL,,,"Assessing an Oral Bruton Tyrosine Kinase Inhibitor, DZD9008 in Patients Who Have Non-Hodgkin B-cell Lymphoma (WU-KONG3)","A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients With Non-Hodgkin B-cell Lymphoma",SUSPENDED,,PHASE1/PHASE2,120.0,ESTIMATED,Dizal Pharmaceuticals,,1.0,,"Clinical development strategy adjustment, non-safety reason",f,,,,,t,f,,,,,,,,,NO,,2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,INDUSTRY,,,,,,,2023,0.0
NCT01035099,,2009-12-07,2020-05-27,,2022-11-18,2009-12-17,2009-12-18,ESTIMATED,2020-07-06,2020-07-07,ACTUAL,,,,2022-11-18,2022-12-13,ACTUAL,2009-11,ACTUAL,2009-11-30,2022-11,2022-11-30,2022-09-30,ACTUAL,2022-09-30,2019-07-23,ACTUAL,2019-07-23,,INTERVENTIONAL,,41 subjects were enrolled; One subject 1 later withdrew consent prior to randomization.,RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVF,A Randomized Open Label Clinical Trial of Fixed Dose Letrozole vs. Titrated Letrozole for In Vitro Fertilization With Cryopreservation of Oocytes and Embryos in Breast Cancer Patients,COMPLETED,,PHASE4,41.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2022,1.0
NCT04343248,,2020-04-08,2024-06-11,2022-06-28,2024-07-02,2020-04-08,2020-04-13,ACTUAL,2024-07-02,2024-07-08,ACTUAL,,2024-07-08,ACTUAL,2024-07-02,2024-07-08,ACTUAL,2020-05-12,ACTUAL,2020-05-12,2024-07,2024-07-31,2021-02-01,ACTUAL,2021-02-01,2021-02-01,ACTUAL,2021-02-01,,INTERVENTIONAL,,The safety population includes all subjects who received at least one dose of study medication.,Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF),"A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)",TERMINATED,,PHASE3,190.0,ACTUAL,Romark Laboratories L.C.,"It was no longer possible to enroll eligible participants in the trial after vaccines were distributed to residents of long-term care facilities. Therefore, enrollment was terminated before the planned enrollment was completed. Study results are summarized descriptively, but no statistical analyses were performed.",2.0,,Study recruitment was halted prematurely as widespread vaccination of the study population made completion infeasible.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,INDUSTRY,,,,,,,2021,0.0
NCT04970407,,2021-07-02,2023-05-18,,2024-02-21,2021-07-20,2021-07-21,ACTUAL,2024-02-21,2024-08-01,ACTUAL,,,,2024-02-21,2024-08-01,ACTUAL,2021-07-06,ACTUAL,2021-07-06,2024-02,2024-02-29,2022-06-08,ACTUAL,2022-06-08,2022-03-16,ACTUAL,2022-03-16,,INTERVENTIONAL,,The Randomized set consisted of all participants who were randomized to study treatment. A participant was considered as randomized if a study intervention group was randomly assigned.,"A Comparative Study to Evaluate the Effects and Mechanism of Action of Dysport®, Botox® and Xeomin® in the Extensor Digitorum Brevis Model in Healthy Adult Male Participants","A Phase I, Randomised, Double-blind, Parallel-group, Single-centre Comparative Study to Evaluate the Pharmacodynamic Profile of Dysport®, Botox®, and Xeomin® in the Extensor Digitorum Brevis (EDB) Model in Healthy Adult Male Participants",COMPLETED,,PHASE1,45.0,ACTUAL,Ipsen,,3.0,,,f,,,,f,f,f,,,t,,,,,,NO,,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,INDUSTRY,,,,,,,2022,1.0
NCT03809455,,2018-10-11,,,2020-04-20,2019-01-15,2019-01-18,ACTUAL,,,,,,,2020-04-20,2020-04-22,ACTUAL,2020-02-01,ESTIMATED,2020-02-01,2020-04,2020-04-30,2023-02-01,ESTIMATED,2023-02-01,2022-02-01,ESTIMATED,2022-02-01,,INTERVENTIONAL,FARADI,,Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients,Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients,WITHDRAWN,,PHASE2,0.0,ACTUAL,UNICANCER,,2.0,,Study was cancelled by Sponsor.,f,,,,t,f,f,,,,,,,,,,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,OTHER,,,,,,,2023,0.0
NCT04163328,,2019-11-12,,,2024-08-21,2019-11-12,2019-11-14,ACTUAL,,,,,,,2024-08-21,2024-08-23,ACTUAL,2022-09-16,ACTUAL,2022-09-16,2024-08,2024-08-31,2024-08-21,ACTUAL,2024-08-21,2024-08-21,ACTUAL,2024-08-21,,INTERVENTIONAL,,,Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort,Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort,TERMINATED,,PHASE4,31.0,ACTUAL,University of Alabama at Birmingham,,2.0,,"COVID disruptions to recruitment and study completion, unforeseen staffing and other issues",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2024,0.0
NCT05039931,,2021-08-22,,,2024-07-17,2021-09-07,2021-09-10,ACTUAL,,,,,,,2024-07-17,2024-07-18,ACTUAL,2021-09-15,ACTUAL,2021-09-15,2024-07,2024-07-31,2023-06,ESTIMATED,2023-06-30,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,"A Study of GNC-035, a Tetra-specific Antibody, in Participants With Locally Advanced or Metastatic Solid Tumors","An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability，Pharmacokinetic/Pharmacodynamics and Anti-tumor Activity of Tetra-specific Antibody GNC-035 in Participants With Locally Advanced or Metastatic Solid Tumors",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Sichuan Baili Pharmaceutical Co., Ltd.",,1.0,,"leading entity of the clinical trial was replaced, and no patients were enrolled.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,INDUSTRY,,,,,,,2023,0.0
NCT05429788,,2022-06-14,,,2024-03-29,2022-06-22,2022-06-23,ACTUAL,,,,,,,2024-03-29,2024-04-02,ACTUAL,2022-05-18,ACTUAL,2022-05-18,2024-03,2024-03-31,2022-11-08,ACTUAL,2022-11-08,2022-11-08,ACTUAL,2022-11-08,,INTERVENTIONAL,,,"Safety, Tolerability, and Efficacy of RLS103 in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD)","A Phase 1b/2a Randomized, Double-Blind, Placebo Controlled, Parallel Study to Evaluate the Safety, Tolerability, and Efficacy of Two Doses of RLS103 (CBD Technosphere® Inhalation Powder) in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD)",WITHDRAWN,,PHASE1,0.0,ACTUAL,Receptor Life Sciences,,3.0,,Lack of enrollment,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 02:35:41.886809,2024-10-16 02:35:41.886809,INDUSTRY,,,,,,,2022,0.0
NCT01239095,,2010-11-09,,,2023-02-21,2010-11-09,2010-11-11,ESTIMATED,,,,,,,2023-02-21,2023-02-22,ACTUAL,2011-07,,2011-07-31,2023-02,2023-02-28,2023-02,ACTUAL,2023-02-28,2023-02,ACTUAL,2023-02-28,,INTERVENTIONAL,,,Oral Green Tea Extract and Milk Thistle Extract to Colorectal Cancer Patients Undergoing Resection,"Perioperative Administration of Oral Green Tea Extract/Milk Thistle Extract to Colorectal Cancer Patients Undergoing Colorectal Cancer Resection, a Phase 1 Study",TERMINATED,,PHASE1,23.0,ACTUAL,Northwell Health,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2023,0.0
NCT05367843,,2022-05-02,,,2024-02-07,2022-05-09,2022-05-10,ACTUAL,,,,,,,2024-02-07,2024-02-09,ACTUAL,2022-06-20,ACTUAL,2022-06-20,2024-02,2024-02-29,2023-11-08,ACTUAL,2023-11-08,2023-07-18,ACTUAL,2023-07-18,,INTERVENTIONAL,,,"A Study Assessing the Safety, Tolerability, Immunogenicity of COVID-19 Vaccine Candidate PRIME-2-CoV_Beta, Orf Virus Expressing SARS-CoV_2 Spike and Nucleocapsid Proteins","A Phase 1, Dose Ranging Study Assessing the Safety, Tolerability, Immunogenicity of Vaccine Candidate PRIME-2-CoV_Beta, Orf Virus Expressing SARS-CoV-2 Spike and Nucleocapsid Proteins (ORFEUS Study)",TERMINATED,,PHASE1,103.0,ACTUAL,Speransa Therapeutics,,3.0,,Business Decision,f,,,,t,t,f,,,,,,,,,,,2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,INDUSTRY,,,,,,,2023,0.0
NCT04171141,,2019-11-08,,,2024-03-05,2019-11-18,2019-11-20,ACTUAL,,,,,,,2024-03-05,2024-03-07,ACTUAL,2019-11-19,ACTUAL,2019-11-19,2024-03,2024-03-31,2023-11-28,ACTUAL,2023-11-28,2023-11-28,ACTUAL,2023-11-28,,INTERVENTIONAL,,,Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.,"A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07062119 IN PATIENTS WITH ADVANCED GASTROINTESTINAL TUMORS",TERMINATED,,PHASE1,79.0,ACTUAL,Pfizer,,7.0,,Study was terminated due to strategic considerations and not due to safety.,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,INDUSTRY,,,,,,,2023,0.0
NCT05118763,,2021-10-27,,,2022-04-07,2021-11-11,2021-11-12,ACTUAL,,,,,,,2022-04-07,2022-04-14,ACTUAL,2022-03-01,ESTIMATED,2022-03-01,2022-04,2022-04-30,2022-12-31,ESTIMATED,2022-12-31,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Intranasal INNA-051 for Prevention of COVID-19 in Adults,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Intranasal INNA-051 for Prevention of COVID-19 in Adults Following Close Contact With Individuals With SARS-CoV-2 Infection",WITHDRAWN,,PHASE2,0.0,ACTUAL,ENA Respiratory Pty Ltd,,3.0,,Sponsor decision,f,,,,t,t,f,,,t,,,,,,NO,No plan,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,INDUSTRY,,,,,,,2022,0.0
NCT05176925,,2021-12-15,,,2024-01-25,2021-12-15,2022-01-04,ACTUAL,,,,,,,2024-01-25,2024-01-29,ACTUAL,2021-01-10,ACTUAL,2021-01-10,2024-01,2024-01-31,2022-09-28,ACTUAL,2022-09-28,2022-06-27,ACTUAL,2022-06-27,,INTERVENTIONAL,,,"Tislelizumab Combined With Sitravatinib as Consolidation Treatment Following Concurrent Chemoradiation in Patients With Locally Advanced, Unresectable NSCLC","A Phase II, Open-Label, Single-Arm, Prospective Clinical Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Sitravatinib as Consolidation Treatment in Patients With Locally Advanced, Unresectable NSCLC Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy",TERMINATED,,PHASE2,5.0,ACTUAL,Fudan University,,1.0,,The trial was terminated per sponsor recommendation,f,,,,,f,f,,,,,,,,,,,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,OTHER,,,,,,,2022,0.0
NCT04416399,,2020-06-03,,,2021-02-03,2020-06-03,2020-06-04,ACTUAL,,,,,,,2021-02-03,2021-02-08,ACTUAL,2020-07-16,ACTUAL,2020-07-16,2020-07,2020-07-31,2021-01-12,ACTUAL,2021-01-12,2021-01-12,ACTUAL,2021-01-12,,INTERVENTIONAL,STOIC,,STerOids in COVID-19 Study,Use of High Dose Inhaled Corticosteroids as Treatment of Early COVID-19 Infection to Prevent Clinical Deterioration and Hospitalisation,TERMINATED,,PHASE2,146.0,ACTUAL,University of Oxford,,2.0,,Independent statistical review advice,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2021,0.0
NCT03309514,,2017-10-10,,,2022-04-04,2017-10-10,2017-10-13,ACTUAL,,,,,,,2022-04-04,2022-04-12,ACTUAL,2022-06,ESTIMATED,2022-06-30,2022-04,2022-04-30,2024-06-30,ESTIMATED,2024-06-30,2023-12-31,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Transplantation of Neural Stem Cell-Derived Neurons for Parkinson's Disease,Clinical Investigation of Transplantation of Neural Stem Cell-derived Neurons for the Treatment of Parkinson's Disease,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,NeuroGeneration,,1.0,,Insufficient funding,f,,,,f,t,f,,,,,,,,,,,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,INDUSTRY,,,,,,,2024,0.0
NCT01882803,,2013-05-31,2018-10-23,2017-05-11,2023-09-05,2013-06-18,2013-06-20,ESTIMATED,2018-10-23,2018-11-20,ACTUAL,2017-05-11,2017-05-12,ACTUAL,2023-09-05,2023-09-07,ACTUAL,2013-06-17,ACTUAL,2013-06-17,2023-09,2023-09-30,2020-11-18,ACTUAL,2020-11-18,2020-11-18,ACTUAL,2020-11-18,,INTERVENTIONAL,DYNAMO,Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib.,A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma,A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma,COMPLETED,,PHASE2,129.0,ACTUAL,SecuraBio,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 23:57:50.724572,2024-10-16 23:57:50.724572,INDUSTRY,,,,,,,2020,1.0
NCT04944654,,2021-06-14,,,2024-05-10,2021-06-21,2021-06-29,ACTUAL,,,,,,,2024-05-10,2024-05-13,ACTUAL,2023-01-07,ACTUAL,2023-01-07,2024-05,2024-05-31,2023-05-11,ACTUAL,2023-05-11,2023-05-11,ACTUAL,2023-05-11,,INTERVENTIONAL,,,"Efficacy, Tolerability and Acceptability of Biktarvy by TPLWH","Efficacy, Tolerability and Acceptability of the Single Table Regimen (STR) Biktarvy® by Trans People Living With HIV (TPLWH)",TERMINATED,,PHASE4,1.0,ACTUAL,Chelsea and Westminster NHS Foundation Trust,,1.0,,"Trial set up was delayed, funding support no longer available",f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2023,0.0
NCT03929640,,2019-04-24,2024-07-09,,2024-08-08,2019-04-24,2019-04-29,ACTUAL,2024-08-08,2024-09-04,ACTUAL,,,,2024-08-08,2024-09-04,ACTUAL,2019-08-05,ACTUAL,2019-08-05,2024-08,2024-08-31,2020-03-26,ACTUAL,2020-03-26,2020-03-14,ACTUAL,2020-03-14,,INTERVENTIONAL,MOPAC,Eligible subjects who received study drug,Management Of Pain After Cesarean Trial,Management Of Pain After Cesarean Trial,TERMINATED,,PHASE3,49.0,ACTUAL,Milton S. Hershey Medical Center,"Enrollment was suspended when the co-investigator responsible for study recruitment left the institution in 2020. At that time, only 49 subjects had been randomized (study enrollment goal was 150 subjects). The PI kept the study open but was not successful in finding a replacement to lead the study so it was eventually terminated.",2.0,,"Lead co-I left institution in 2020 and enrollment was suspended. Study was kept open in hopes of finding a replacement/meeting enrollment goal, but a new lead was not found. Study is now officially closed.",f,,,,,t,f,,,f,,,,,,NO,"May collaborate with PSU Addiction Center to perform secondary analyses on data collected, including total opiate consumption and pain scores.",2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,OTHER,,,,,,,2020,0.0
NCT03370120,,2017-12-07,2021-11-30,,2021-11-30,2017-12-07,2017-12-12,ACTUAL,2021-11-30,2021-12-29,ACTUAL,,,,2021-11-30,2021-12-29,ACTUAL,2018-08-27,ACTUAL,2018-08-27,2021-11,2021-11-30,2020-12-11,ACTUAL,2020-12-11,2020-12-11,ACTUAL,2020-12-11,,INTERVENTIONAL,,"The Safety Set (SS) consisted of all enrolled participants who were administered at least 1 dose of PSL, based on the first dose date from the first administration of study medication Case Report form (CRF).",Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy,"An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy",TERMINATED,,PHASE2,406.0,ACTUAL,UCB Pharma,,1.0,,"Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure",f,,,,f,t,f,,,f,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",http://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,INDUSTRY,,,,,,,2020,0.0
NCT04348500,,2020-04-13,2021-11-23,,2024-02-06,2020-04-13,2020-04-16,ACTUAL,2021-11-30,2021-12-02,ACTUAL,,,,2024-02-06,2024-02-08,ACTUAL,2020-04-28,ACTUAL,2020-04-28,2024-02,2024-02-29,2020-09-30,ACTUAL,2020-09-30,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,,Enrolled patients who received the initial dose of the IP were analyzed.,Clazakizumab (Anti-Interleukin 6 (IL-6) Monoclonal) Compared to Placebo for Coronavirus Disease 2019 (COVID-19),A Phase II Trial to Evaluate the Safety and Tolerability of Clazakizumab® (Anti-IL-6 Monoclonal) Compared to Placebo for the Treatment of COVID-19 Infection,COMPLETED,,PHASE2,17.0,ACTUAL,Cedars-Sinai Medical Center,"Due to the small sample size, unable to assess statistical significance between the treatment and placebo group.",2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,OTHER,,,,,,,2020,1.0
NCT04017390,,2019-07-04,,,2022-01-05,2019-07-11,2019-07-12,ACTUAL,,,,,,,2022-01-05,2022-01-21,ACTUAL,2022-01-01,ESTIMATED,2022-01-01,2022-01,2022-01-31,2022-01-03,ACTUAL,2022-01-03,2022-01-03,ACTUAL,2022-01-03,,INTERVENTIONAL,,,The Effect of Theraworx Foam in Carpal Tunnel Syndrome,The Effect of Theraworx Foam on the Cross-sectional Area of the Median Nerve in Patients With Carpal Tunnel Syndrome,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Pittsburgh,,4.0,,Lack of Funding from Sponsor,f,,,,f,t,f,,,f,,,Updated at intervals of approximately 60 days (minimum) and as needed as determined by PI. Final data will be available approximately 12 months after completion of last participant and will be available for 9 to 12 months.,,,YES,"The ultrasound measurements and PRO questionnaire scores will be shared with the sponsor Avadim Technologies at a minimum of approximately 60 day intervals throughout the study (1 year) and at the discretion of the PI. In addition, final data will be provided within 12 months of completion of last participant",2024-10-15 15:24:52.208295,2024-10-15 15:24:52.208295,OTHER,,,,,,,2022,0.0
NCT03972709,,2019-05-31,2023-09-18,,2024-03-26,2019-05-31,2019-06-04,ACTUAL,2024-03-26,2024-03-27,ACTUAL,,,,2024-03-26,2024-03-27,ACTUAL,2019-06-03,ACTUAL,2019-06-03,2024-03,2024-03-31,2022-10-27,ACTUAL,2022-10-27,2022-10-27,ACTUAL,2022-10-27,,INTERVENTIONAL,GALLEGO,,"A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)","A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study to Assess Safety, Tolerability, and Efficacy of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GALLEGO)",TERMINATED,,PHASE2,372.0,ACTUAL,"Genentech, Inc.",,4.0,,The benefit to risk balance did not support further treatment with galegenimab (FHTR2163).,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,INDUSTRY,,,,,,,2022,0.0
NCT05519527,,2022-08-25,,,2023-08-29,2022-08-25,2022-08-29,ACTUAL,,,,,,,2023-08-29,2023-08-31,ACTUAL,2022-08-16,ACTUAL,2022-08-16,2023-08,2023-08-31,2023-02-15,ACTUAL,2023-02-15,2023-02-15,ACTUAL,2023-02-15,,INTERVENTIONAL,,,STI-6129 CD38 ADC for the Treatment of Patients With Relapsed or Refractory Systemic ALL Amyloidosis,A Phase 1 Study of Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory T-Acute Lymphoblastic Leukemia/Lymphoma (T-ALL) or Acute Myeloid Leukemia (AML),WITHDRAWN,,PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,0 patient accrual,,,,,t,t,f,,,,,,,,,,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2023,0.0
NCT03640221,,2018-08-01,,,2020-01-10,2018-08-17,2018-08-21,ACTUAL,,,,,,,2020-01-10,2020-01-14,ACTUAL,2018-09-01,ESTIMATED,2018-09-01,2018-08,2018-08-31,2020-08-31,ESTIMATED,2020-08-31,2020-05-31,ESTIMATED,2020-05-31,,INTERVENTIONAL,Ertugliflozin,,Ertugliflozin Versus Hydrochlorothiazide in Reducing Sympathetic Neural Overactivity in Patients With Hypertension and Recently-diagnosed Type 2 Diabetes.,"A Double-blind, Randomized, Parallel 2- Arm Study to Compare the Efficacy of Ertugliflozin Versus Hydrochlorothiazide in Reducing Sympathetic Neural Overactivity in Patients With Hypertension and Recently-diagnosed Type 2 Diabetes Who Are Receiving Background Standard-of-care Cardio-metabolic Therapy With Metformin, an Angiotensin Converting Enzyme Inhibitor or Angiotensin Receptor Blocker, and a Statin.",WITHDRAWN,,PHASE4,0.0,ACTUAL,Cedars-Sinai Medical Center,,2.0,,Study withdrawn prior to IRB approval and enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,OTHER,,,,,,,2020,0.0
NCT04493619,,2020-07-23,,,2022-10-04,2020-07-27,2020-07-30,ACTUAL,,,,,,,2022-10-04,2022-10-05,ACTUAL,2020-08-11,ACTUAL,2020-08-11,2022-10,2022-10-31,2022-04-25,ACTUAL,2022-04-25,2022-04-25,ACTUAL,2022-04-25,,INTERVENTIONAL,,,PLX2853 as a Single Agent in Advanced Gynecological Malignancies and in Combination With Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer,"A Multicenter, Open-Label, Parallel, Phase 2a Study of PLX2853 Monotherapy in Advanced Gynecological Malignancies With a Known ARID1A Mutation and Phase 1b/2a Study of PLX2853/Carboplatin Combination Therapy in Platinum-Resistant Epithelial Ovarian Cancer",TERMINATED,,PHASE1/PHASE2,37.0,ACTUAL,Opna Bio LLC,,2.0,,study terminated due to business realignment,f,,,,f,t,f,,,,,,,,,,,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,INDUSTRY,,,,,,,2022,0.0
NCT02878538,,2016-08-05,,,2018-02-05,2016-08-19,2016-08-25,ESTIMATED,,,,,,,2018-02-05,2018-02-06,ACTUAL,2018-01,ESTIMATED,2018-01-31,2017-08,2017-08-31,2023-04,ESTIMATED,2023-04-30,2022-04,ESTIMATED,2022-04-30,,INTERVENTIONAL,,,A Pilot of the Feasibility of Using the Iron-Chelator Deferiprone on Mild Cognitive Impairment,An N of One Clinical Trial to Pilot the Feasibility of Using the Iron-Chelator Deferiprone on Mild Cognitive Impairment,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,The University of Texas Health Science Center at San Antonio,,2.0,,Study was withdrawn before IRB approval,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2023,0.0
NCT04811404,,2021-03-19,,,2022-10-12,2021-03-19,2021-03-23,ACTUAL,,,,,,,2022-10-12,2022-10-14,ACTUAL,2021-03-19,ACTUAL,2021-03-19,2022-10,2022-10-31,2022-07-01,ACTUAL,2022-07-01,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,,,"A PET Study With [11C]PBR-28 and an Experimental Medication, Ethyl Eicosapentaenoic Acid","A PET Study With [11C]PBR-28 and an Experimental Medication, Ethyl Eicosapentaenoic Acid",WITHDRAWN,,PHASE4,0.0,ACTUAL,New York State Psychiatric Institute,,1.0,,Reassessment of rationale for study,,,,,f,t,f,,,,,,,,,NO,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2022,0.0
NCT02263729,,2014-09-26,2023-12-26,,2024-04-09,2014-10-08,2014-10-13,ESTIMATED,2024-04-09,2024-05-02,ACTUAL,,,,2024-04-09,2024-05-02,ACTUAL,2016-08-10,ACTUAL,2016-08-10,2024-04,2024-04-30,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,Phase 1/2 Prospective Double-Blind Placebo-Controlled Randomized Clinical Trial of Losartan to Treat Grade II & III Hamstring Strains,"Phase 1/2 Prospective Double-blind, Placebo-controlled Randomized Clinical Trial Using Losartan to Treat Grade II and III Hamstring Strains",TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,University of Pittsburgh,"Recruitment was complicated primarily due to delays in identifying potential study participants, as individuals were often excluded for presenting \> 7 days from injury (n=106), not having at least a grade 2 injury (n=9), or refusing participation (n=9). The study was terminated due to the expiration of funding, which resulted in a sample size of 6 participants. Given this sample size was smaller than anticipated, no between-group significance testing was performed.",2.0,,The study was terminated due to difficulty identifying eligible participants and the expiration of funding.,f,,,,f,,,,,,,,,,,,,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,OTHER,,,,,,,2022,0.0
NCT05456854,,2022-07-08,,,2024-08-11,2022-07-08,2022-07-13,ACTUAL,,,,,,,2024-08-11,2024-08-14,ACTUAL,2022-06-03,ACTUAL,2022-06-03,2024-08,2024-08-31,2024-08-01,ESTIMATED,2024-08-01,2024-08-01,ESTIMATED,2024-08-01,,INTERVENTIONAL,,,Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp,Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp,WITHDRAWN,,PHASE1,0.0,ACTUAL,Massachusetts General Hospital,,2.0,,Futility,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,OTHER,,,,,,,2024,0.0
NCT06020664,,2023-07-10,,,2024-01-11,2023-08-29,2023-08-31,ACTUAL,,,,,,,2024-01-11,2024-01-16,ACTUAL,2023-08-16,ACTUAL,2023-08-16,2024-01,2024-01-31,2024-11-24,ESTIMATED,2024-11-24,2024-09,ESTIMATED,2024-09-30,,INTERVENTIONAL,NTCDU,,NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers (NTCDU),"A Randomized, Placebo Controlled, Evaluator-Blinded Study to Assess the Efficacy and Safety of NOX1416 in the Treatment of Chronic, Non-Healing, Diabetic Foot Ulcers",SUSPENDED,,PHASE1,30.0,ESTIMATED,"NOxy Health Products, LLC",,2.0,,"The NO-002 study had to be paused because of enrollment disruptions due to the current situation in Israel, and concerns over the placebo batch stability results.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,INDUSTRY,,,,,,,2024,0.0
NCT02799745,,2016-02-29,2021-08-27,,2021-10-14,2016-06-10,2016-06-15,ESTIMATED,2021-10-14,2021-11-10,ACTUAL,,,,2021-10-14,2021-11-10,ACTUAL,2016-06-09,ACTUAL,2016-06-09,2021-10,2021-10-31,2020-08-28,ACTUAL,2020-08-28,2020-08-28,ACTUAL,2020-08-28,,INTERVENTIONAL,ENACT,The full analysis set (FAS) consisted of all participants who were randomized.,A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance,A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance (ENACT),COMPLETED,,PHASE2,227.0,ACTUAL,Astellas Pharma Inc,,2.0,,,f,,,,f,t,f,,,,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://www.clinicalstudydatarequest.com/,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,INDUSTRY,,,,,,,2020,1.0
NCT03364738,,2017-11-20,2021-04-14,,2022-09-30,2017-12-01,2017-12-07,ACTUAL,2021-05-21,2021-06-16,ACTUAL,,,,2022-09-30,2022-10-07,ACTUAL,2018-09-26,ACTUAL,2018-09-26,2021-05,2021-05-31,2020-04-14,ACTUAL,2020-04-14,2020-04-14,ACTUAL,2020-04-14,,INTERVENTIONAL,,The safety analysis population consisted of all participants who have received at least 1 dose of rhPTH(1-84).,Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism,An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects With Hypoparathyroidism,TERMINATED,,PHASE3,22.0,ACTUAL,Takeda,The study was terminated due to Takeda commercial Natpara recall.,1.0,,The study was terminated due to Takeda commercial Natpara recall.,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,INDUSTRY,,,,,,,2020,0.0
NCT03425331,,2018-02-01,2023-12-20,,2024-08-20,2018-02-01,2018-02-07,ACTUAL,2024-08-20,2024-08-22,ACTUAL,,,,2024-08-20,2024-08-22,ACTUAL,2018-04-10,ACTUAL,2018-04-10,2024-08,2024-08-31,2021-11-28,ACTUAL,2021-11-28,2020-05-18,ACTUAL,2020-05-18,,INTERVENTIONAL,,,Biomarkers of Response to Ipilimumab and Nivolumab in First-line NSCLC,"Biomarkers of Response to Ipilimumab and Nivolumab as First-line Therapy for Metastatic Non-small Cell Lung Cancer (NSCLC): an Open-label, Single Arm Phase 2 Study",TERMINATED,,PHASE2,5.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,"Slow accrual, competing studies, and lack of efficacy",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2021,0.0
NCT00703326,,2008-06-20,2014-05-16,2010-07-29,2021-11-03,2008-06-20,2008-06-23,ESTIMATED,2014-05-16,2014-06-17,ESTIMATED,2010-07-29,2010-07-30,ESTIMATED,2021-11-03,2021-12-06,ACTUAL,2008-08-06,ACTUAL,2008-08-06,2021-11,2021-11-30,2020-11-19,ACTUAL,2020-11-19,2013-03-31,ACTUAL,2013-03-31,,INTERVENTIONAL,,Intent-to-Treat (ITT) Population: All randomized participants.,Phase III Study of Docetaxel + Ramucirumab or Placebo in Breast Cancer,"A Multicenter, Multinational, Randomized, Double-Blind, Phase III Study of IMC-1121B Plus Docetaxel Versus Placebo Plus Docetaxel in Previously Untreated Patients With HER2-Negative, Unresectable, Locally-Recurrent or Metastatic Breast Cancer",COMPLETED,,PHASE3,1144.0,ACTUAL,Eli Lilly and Company,"One participant assigned to placebo + docetaxel (doc) treatment and was given ramucirumab (ram) in Cycle 1. Considered ram + doc treatment arm for safety population, for ITT population the participant was analyzed according to assigned treatment.",2.0,,,f,,,,t,,,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and european union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,INDUSTRY,,,,,,,2020,1.0
NCT04575584,,2020-09-30,2022-07-20,,2023-01-13,2020-10-02,2020-10-05,ACTUAL,2022-07-20,2022-08-16,ACTUAL,,,,2023-01-13,2023-01-17,ACTUAL,2020-10-19,ACTUAL,2020-10-19,2023-01,2023-01-31,2021-08-11,ACTUAL,2021-08-11,2021-08-11,ACTUAL,2021-08-11,,INTERVENTIONAL,,No participants were enrolled in Part 2 arms due to early study termination.,Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001),"A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Hospitalized Adults With COVID-19",TERMINATED,,PHASE2/PHASE3,304.0,ACTUAL,Merck Sharp & Dohme LLC,,6.0,,Business reasons,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,INDUSTRY,,,,,,,2021,0.0
NCT03904316,,2019-03-18,,,2022-08-10,2019-04-03,2019-04-05,ACTUAL,,,,,,,2022-08-10,2022-08-12,ACTUAL,2018-10-03,ACTUAL,2018-10-03,2022-08,2022-08-31,2022-07-01,ACTUAL,2022-07-01,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,,,Use of Biodesign® Otologic Graft in Tympanoplasty,"Use of Biodesign® Otologic Graft in Tympanoplasty: A Prospective, Randomized Trial",WITHDRAWN,,PHASE4,0.0,ACTUAL,Ascension South East Michigan,,2.0,,The trial was stopped as the benefit was challenging to determine in preliminary usage.,f,,,,f,t,f,,,f,,,,,,,,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,OTHER,,,,,,,2022,0.0
NCT03938454,,2019-05-02,,2023-10-31,2024-04-02,2019-05-02,2019-05-06,ACTUAL,,,,,2024-01-08,ACTUAL,2024-04-02,2024-04-04,ACTUAL,2019-10-16,ACTUAL,2019-10-16,2024-04,2024-04-30,2023-11-29,ACTUAL,2023-11-29,2023-03-28,ACTUAL,2023-03-28,,INTERVENTIONAL,SPARTAN,,A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism,"A Prospective Phase II, Open-Label, Single-arm, Multicenter, Study to Assess Efficacy and Safety of SEG101 (Crizanlizumab), in Sickle Cell Disease Patients With Priapism (SPARTAN)",COMPLETED,,PHASE2,36.0,ACTUAL,Novartis,,1.0,,,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,INDUSTRY,,,,,,,2023,1.0
NCT03414788,,2018-01-08,,,2020-10-30,2018-01-26,2018-01-30,ACTUAL,,,,,,,2020-10-30,2020-11-03,ACTUAL,2020-12-07,ESTIMATED,2020-12-07,2020-10,2020-10-31,2022-02-01,ESTIMATED,2022-02-01,2022-02-01,ESTIMATED,2022-02-01,,INTERVENTIONAL,,,Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis and Crohn's Disease,"PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB)-PF-06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF-06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE AND CROHN'S COLITIS SUBJECTS",WITHDRAWN,,PHASE1,0.0,ACTUAL,Pfizer,,1.0,,The study was withdrawn due to not being able to recruit subjects.,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,INDUSTRY,,,,,,,2022,0.0
NCT04320615,,2020-03-23,2021-06-23,,2021-06-28,2020-03-23,2020-03-25,ACTUAL,2021-06-28,2021-06-30,ACTUAL,,,,2021-06-28,2021-06-30,ACTUAL,2020-04-03,ACTUAL,2020-04-03,2021-06,2021-06-30,2020-07-28,ACTUAL,2020-07-28,2020-06-24,ACTUAL,2020-06-24,,INTERVENTIONAL,COVACTA,,A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia,"A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia",COMPLETED,,PHASE3,452.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform https://vivli.org.~Further details on Roche's criteria for eligible studies are available here: https://vivli.org.~For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm",2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,INDUSTRY,,,,,,,2020,1.0
NCT02694393,,2016-01-11,2023-07-21,,2024-06-18,2016-02-23,2016-02-29,ESTIMATED,2024-06-18,2024-06-24,ACTUAL,,,,2024-06-18,2024-06-24,ACTUAL,2016-02,,2016-02-29,2024-06,2024-06-30,2022-07-21,ACTUAL,2022-07-21,2022-07-21,ACTUAL,2022-07-21,,INTERVENTIONAL,,,Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis,Phase I/II Study of Inhaled Sodium Nitrite as an Antimicrobial for Pseudomonas Infection in Cystic Fibrosis,TERMINATED,,PHASE1/PHASE2,4.0,ACTUAL,University of Pittsburgh,The study was terminated early due to expiration of investigational product and lack of a manufacturer.,1.0,,Protocol closed due to difficulty recruiting subjects and then expiration of investigational product and lack of a manufacturer.,f,,,,t,,,,,,,,,,,NO,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2022,0.0
NCT03000179,,2016-12-06,2022-02-18,,2022-03-22,2016-12-17,2016-12-21,ESTIMATED,2022-03-22,2022-04-14,ACTUAL,,,,2022-03-22,2022-04-14,ACTUAL,2017-03-03,ACTUAL,2017-03-03,2022-03,2022-03-31,2021-08-03,ACTUAL,2021-08-03,2021-08-03,ACTUAL,2021-08-03,,INTERVENTIONAL,,,Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma,Pilot Study to Investigate the Safety and Efficacy of Avelumab Monotherapy in Patients With Advanced or Metastatic Adenocarcinoma of the Small Intestine,TERMINATED,,PHASE2,8.0,ACTUAL,Vanderbilt-Ingram Cancer Center,,1.0,,Low accrual,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2021,0.0
NCT01865630,,2013-05-27,,,2020-10-29,2013-05-27,2013-05-31,ESTIMATED,,,,,,,2020-10-29,2020-11-02,ACTUAL,2021-01,ESTIMATED,2021-01-31,2020-10,2020-10-31,2022-01,ESTIMATED,2022-01-31,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,,,Safety and Efficacy Study of Etanercept for Aneurysmal Subarachnoid Hemorrhage,"Phase I Safety, Blood Brain Barrier Permeability and Potential Efficacy of Etanercept for Aneurysmal Subarachnoid Hemorrhage",WITHDRAWN,,PHASE1,0.0,ACTUAL,Unity Health Toronto,,1.0,,PI moved to another institution,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2022,0.0
NCT02963051,,2016-11-10,,,2021-09-13,2016-11-10,2016-11-15,ESTIMATED,,,,,,,2021-09-13,2021-09-16,ACTUAL,2017-07-11,ACTUAL,2017-07-11,2021-09,2021-09-30,2020-02-01,ACTUAL,2020-02-01,2018-12-30,ACTUAL,2018-12-30,,INTERVENTIONAL,,,"A Phase Ib Study of Intravenous Copper Loading With Oral Disulfiram in Metastatic, Castration Resistant Prostate Cancer","A Phase Ib Study of Intravenous Copper Loading With Oral Disulfiram in Metastatic, Castration Resistant Prostate Cancer",TERMINATED,,PHASE1,9.0,ACTUAL,Duke University,,3.0,,Study stopped due to lack of efficacy.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,OTHER,,,,,,,2020,0.0
NCT02035085,,2013-12-19,,,2022-06-21,2014-01-10,2014-01-14,ESTIMATED,,,,,,,2022-06-21,2022-06-27,ACTUAL,2014-06,ACTUAL,2014-06-30,2022-06,2022-06-30,2022-06,ACTUAL,2022-06-30,2022-06,ACTUAL,2022-06-30,,INTERVENTIONAL,CS-1000,,19F Hot Spot MRI of Human Adipose-derived Stem Cells for Breast Reconstruction,"This is a First-in-man, Phase I Study Utilizing 19F Magnetic Resonance Imaging (MRI) to Track Autologous, Adipose Derived Stem Cells.",WITHDRAWN,,PHASE1,0.0,ACTUAL,Johns Hopkins University,,1.0,,Drugs/devices discontinued,f,,,,f,t,f,,,,,,,,,,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2022,0.0
NCT04082715,,2019-08-06,,,2020-01-06,2019-09-06,2019-09-09,ACTUAL,,,,,,,2020-01-06,2020-01-09,ACTUAL,2019-10,ESTIMATED,2019-10-31,2020-01,2020-01-31,2023-12,ESTIMATED,2023-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,"Transition From Acute to Chronic Back Pain : Effect of L-dopa,Gender,and Associated Brain Plasticity","Transition From Acute to Chronic Back Pain : Effect of L-dopa,Gender,and Associated Brain Plasticity",WITHDRAWN,,PHASE2,0.0,ACTUAL,Second Affiliated Hospital of Wenzhou Medical University,,3.0,,we don't have enough research funding.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,OTHER,,,,,,,2023,0.0
NCT03121534,,2017-04-14,2023-01-20,,2023-02-16,2017-04-19,2017-04-20,ACTUAL,2023-02-16,2023-02-17,ACTUAL,,,,2023-02-16,2023-02-17,ACTUAL,2017-06-22,ACTUAL,2017-06-22,2023-01,2023-01-31,2022-02-11,ACTUAL,2022-02-11,2022-02-11,ACTUAL,2022-02-11,,INTERVENTIONAL,,,"Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation","A Phase II Study of Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation",TERMINATED,,PHASE2,9.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,The study was closed for slow accrual,f,,,,f,t,f,,,,,,,,,,,2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,OTHER,,,,,,,2022,0.0
NCT04331002,,2019-07-27,2023-07-06,,2023-07-06,2020-03-30,2020-04-02,ACTUAL,2023-07-06,2023-07-27,ACTUAL,,,,2023-07-06,2023-07-27,ACTUAL,2020-08-21,ACTUAL,2020-08-21,2023-07,2023-07-31,2022-07-11,ACTUAL,2022-07-11,2022-07-11,ACTUAL,2022-07-11,,INTERVENTIONAL,SLAM,Research cancelled and 0 participants enrolled in Arm 2,Success of Long-acting Anti-inflammatories After Anterior Cruciate Ligament and Meniscal Injury,Success of Long-acting Anti-inflammatories After Anterior Cruciate Ligament and Meniscal Injury,TERMINATED,,PHASE2,1.0,ACTUAL,University of Kentucky,,2.0,,Funding Termination,f,,,,t,t,f,,,t,,,"Access to individual participant data will be available 1 year after the final study follow-up has been completed, and will be available until 5 years after the final study follow-up has been completed.",The researchers requesting access to participant information or samples must complete a questionnaire describing why they need information or samples for their research and how they will use the information or samples. The researchers who receive the information or samples will sign an agreement to use the data responsibly.,,YES,"With the participant's approval and as approved by local Institutional Review Boards (IRBs), de-identified biological samples will be stored at the University of Kentucky Orthopedic Biomarker Repository. These samples could be used to research the causes of osteoarthritis after meniscus injury, its complications and other conditions for which individuals with meniscus injuries are at increased risk, and to improve treatment.~Before sharing biomarker samples, we will ensure that the participant has given previous consent to the sharing of the information or samples. When we confirm that the previously provided consent is still in effect we will remove identifiers such as (e.g., name, medical record number, or date of birth). We will use a secure electronic log to track information shared without releasing the individual participant's identity.",2024-10-15 01:48:21.68177,2024-10-15 01:48:21.68177,OTHER,,,,,,,2022,0.0
NCT03991000,,2019-06-17,,,2023-12-19,2019-06-17,2019-06-19,ACTUAL,,,,,,,2023-12-19,2023-12-27,ACTUAL,2019-02-28,ACTUAL,2019-02-28,2023-12,2023-12-31,2021-12-15,ACTUAL,2021-12-15,2021-12-15,ACTUAL,2021-12-15,,INTERVENTIONAL,iCHF-2,,Iron in Patients With Cardiovascular Disease,"Investigator-initiated, Randomized, Double-blind, Controlled, Multi-center Trial of Intravenous Iron in Patients With Cardiovascular Disease and Concomitant Iron Deficiency",TERMINATED,,PHASE3,8.0,ACTUAL,Universitätsklinikum Hamburg-Eppendorf,,2.0,,"Due to poor recruitment largely due to the covid pandemic, no safety concerns.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2021,0.0
NCT01895829,,2013-07-03,,,2021-09-15,2013-07-05,2013-07-11,ESTIMATED,,,,,,,2021-09-15,2021-09-21,ACTUAL,2013-09-12,ACTUAL,2013-09-12,2021-09,2021-09-30,2021-09-07,ACTUAL,2021-09-07,2021-09-07,ACTUAL,2021-09-07,,INTERVENTIONAL,,,Ferumoxytol - Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI,Pilot Feasibility Study of Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI for Primary and Nodal Tumor Imaging in Locally Advanced Head and Neck Squamous Cell Carcinomas,TERMINATED,,EARLY_PHASE1,7.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Study halted prematurely and will not resume,f,,,,f,t,f,,,,,,,,,,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2021,0.0
NCT03147040,,2017-05-04,,,2022-07-15,2017-05-09,2017-05-10,ACTUAL,,,,,,,2022-07-15,2022-07-19,ACTUAL,2017-11-02,ACTUAL,2017-11-02,2022-07,2022-07-31,2022-07-01,ACTUAL,2022-07-01,2022-05-01,ACTUAL,2022-05-01,,INTERVENTIONAL,GELATO,,AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer,AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer: GELATO-trial,TERMINATED,,PHASE2,23.0,ACTUAL,The Netherlands Cancer Institute,,1.0,,At interim analysis insufficient benefit was observed to continu the study,f,,,,f,f,f,,,,,,,,,UNDECIDED,to be decided,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2022,0.0
NCT03060473,,2017-02-10,2024-04-08,,2024-06-04,2017-02-17,2017-02-23,ACTUAL,2024-06-04,2024-06-25,ACTUAL,,,,2024-06-04,2024-06-25,ACTUAL,2017-02-23,ACTUAL,2017-02-23,2024-06,2024-06-30,2023-12-08,ACTUAL,2023-12-08,2023-12-08,ACTUAL,2023-12-08,,INTERVENTIONAL,TREAT,,Treatment of ppROM With Erythromycin vs. Azithromycin Trial,TREAT: Treatment of ppROM With Erythromycin vs. Azithromycin Trial,TERMINATED,,PHASE3,21.0,ACTUAL,"The University of Texas Medical Branch, Galveston",No data collected. The protocol was closed early due to low accrual and deemed futile.,2.0,,"Patient population that meets study criteria is insufficient to continue project in a reasonable amount of time. To continue is futile in resources, staff time, and effort.",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,OTHER,,,,,,,2023,0.0
NCT04037241,,2019-07-26,,,2022-03-30,2019-07-26,2019-07-30,ACTUAL,,,,,,,2022-03-30,2022-04-01,ACTUAL,2021-11-01,ESTIMATED,2021-11-01,2022-03,2022-03-31,2022-01-01,ESTIMATED,2022-01-01,2022-01-01,ESTIMATED,2022-01-01,,INTERVENTIONAL,,,Study of Anti-CEA CAR-T + Chemotherapy VS Chemotherapy Alone in Patients With CEA+Pancreatic Cancer & Liver Metastases,A Randomized Open-Label Phase 2b Study of Hepatic Infusions of Anti-CEA CAR-T Cells Alternating With Systemic Chemotherapy Versus Chemotherapy Alone In Patients With Liver Metastases Due To CEA-Expressing Pancreatic Adenocarcinoma,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,8.0,,Sponsor terminated,f,,,,t,t,f,,,,,,,,,,,2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,INDUSTRY,,,,,,,2022,0.0
NCT04478994,,2020-07-16,2023-11-08,,2024-06-18,2020-07-16,2020-07-21,ACTUAL,2023-11-08,2024-04-19,ACTUAL,,,,2024-06-18,2024-06-28,ACTUAL,2021-11-17,ACTUAL,2021-11-17,2024-06,2024-06-30,2022-12-08,ACTUAL,2022-12-08,2022-11-29,ACTUAL,2022-11-29,,INTERVENTIONAL,,,A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc),"A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics, and Explore Efficacy of TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis",TERMINATED,,PHASE1,3.0,ACTUAL,Amgen,,2.0,,Poor enrollment,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,INDUSTRY,,,,,,,2022,0.0
NCT04450316,,2020-06-24,,,2023-12-16,2020-06-24,2020-06-29,ACTUAL,,,,,,,2023-12-16,2023-12-22,ACTUAL,2020-10-08,ACTUAL,2020-10-08,2023-12,2023-12-31,2024-10,ESTIMATED,2024-10-31,2024-07,ESTIMATED,2024-07-31,,INTERVENTIONAL,,,Low-dose Naltrexone for Bladder Pain Syndrome,Low-dose Naltrexone for Bladder Pain Syndrome: A Randomized Placebo-controlled Prospective Pilot Trial,SUSPENDED,,PHASE2,40.0,ESTIMATED,Stanford University,,2.0,,Study temporarily suspended awaiting research personnel to resume recruitment,f,,,,f,t,f,,,f,,,,,,NO,"Should the study result be positive or promising, we would undertake a larger trial at which point we can reassess the sharing of IPD.",2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2024,0.0
NCT03898180,,2019-03-29,2023-10-06,,2024-07-10,2019-03-29,2019-04-01,ACTUAL,2023-10-06,2023-10-31,ACTUAL,,,,2024-07-10,2024-07-22,ACTUAL,2019-05-06,ACTUAL,2019-05-06,2024-07,2024-07-31,2024-05-20,ACTUAL,2024-05-20,2021-07-26,ACTUAL,2021-07-26,,INTERVENTIONAL,,,Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011),"A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011)",COMPLETED,,PHASE3,487.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,INDUSTRY,,,,,,,2024,1.0
NCT04764383,,2021-02-18,,,2021-07-22,2021-02-18,2021-02-21,ACTUAL,,,,,,,2021-07-22,2021-07-29,ACTUAL,2022-01-01,ESTIMATED,2022-01-01,2021-07,2021-07-31,2022-10-30,ESTIMATED,2022-10-30,2022-10-30,ESTIMATED,2022-10-30,,INTERVENTIONAL,,,Histaminergic Basis of Fatigue in Multiple Sclerosis,Histaminergic Basis of Fatigue in Multiple Sclerosis,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Miami,,3.0,,Withdrawn as more data drug analysis is recommended before the study.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,OTHER,,,,,,,2022,0.0
NCT02853071,,2016-07-29,,,2019-11-15,2016-08-01,2016-08-02,ESTIMATED,,,,,,,2019-11-15,2019-11-18,ACTUAL,2017-01,,2017-01-31,2019-11,2019-11-30,2020-01,ESTIMATED,2020-01-31,2020-01,ESTIMATED,2020-01-31,,INTERVENTIONAL,BEST,,Efficacy and Safety of Estracyt® in Metastatic Breast Cancer,"Efficacy and Safety of Estracyt® in Metastatic Breast Cancer Hormonal Estrogen Receptor (HER 2) Negative, Hormone Receptor (HR) Positive.",WITHDRAWN,,PHASE2,0.0,ACTUAL,Centre Hospitalier Universitaire de Besancon,,2.0,,withdrawal industrial,f,,,,t,,,,,,,,,,,YES,The Committee shall meet twice a year,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,OTHER,,,,,,,2020,0.0
NCT02985021,,2016-11-22,2021-04-19,,2021-08-03,2016-12-04,2016-12-07,ESTIMATED,2021-08-03,2021-08-05,ACTUAL,,,,2021-08-03,2021-08-05,ACTUAL,2016-11,,2016-11-30,2021-08,2021-08-31,2021-04,ACTUAL,2021-04-30,2021-04,ACTUAL,2021-04-30,,INTERVENTIONAL,,"Patients with metastatic, resistant prostate cancer",Docetaxel and Carboplatin for Patients With mCRPC and DNA-Repair Deficiencies,"A Phase 2 Study of Docetaxel and Carboplatin for Treatment of Patients With Metastatic, Castration Resistant Prostate Cancer and Germline or Somatic DNA Repair Deficiency",TERMINATED,,PHASE2,2.0,ACTUAL,Seattle Institute for Biomedical and Clinical Research,,1.0,,Competing studies,f,,,,t,,,,,,,,,,,NO,,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,OTHER,,,,,,,2021,0.0
NCT02753530,,2016-04-25,2023-01-24,,2023-04-18,2016-04-27,2016-04-28,ESTIMATED,2023-04-18,2023-05-10,ACTUAL,,,,2023-04-18,2023-05-10,ACTUAL,2017-08-16,ACTUAL,2017-08-16,2023-04,2023-04-30,2021-01-11,ACTUAL,2021-01-11,2021-01-11,ACTUAL,2021-01-11,,INTERVENTIONAL,,Intention-to-treat (ITT) population. Patients randomized in error (1 patient in the arimoclomol group and 1 patient in the placebo group) were not included in the ITT population.,Study of Arimoclomol in Inclusion Body Myositis (IBM),Phase II Study of Arimoclomol for the Treatment of Sporadic Inclusion Body Myositis (IBM),COMPLETED,,PHASE2,152.0,ACTUAL,ZevraDenmark,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,INDUSTRY,,,,,,,2021,1.0
NCT03087448,,2017-02-10,,,2022-12-22,2017-03-16,2017-03-22,ACTUAL,,,,,,,2022-12-22,2022-12-27,ACTUAL,2017-09-09,ACTUAL,2017-09-09,2022-12,2022-12-31,2022-04-30,ACTUAL,2022-04-30,2022-04-30,ACTUAL,2022-04-30,,INTERVENTIONAL,,,Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC),A Phase I/II Study of Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC),TERMINATED,,PHASE1,9.0,ACTUAL,"University of California, San Francisco",,1.0,,Low Accrual,f,,,,t,t,f,,,t,,,,,,NO,Individual participant data (IPD) will not be shared,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2022,0.0
NCT02640833,,2015-12-23,,,2016-07-22,2015-12-23,2015-12-29,ESTIMATED,,,,,,,2016-07-22,2016-07-26,ESTIMATED,2016-07,,2016-07-31,2016-07,2016-07-31,2021-02,ESTIMATED,2021-02-28,2020-01,ESTIMATED,2020-01-31,,INTERVENTIONAL,,,"A Study of Duvelisib and Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Indolent or Aggressive Non-Hodgkin Lymphoma, Who Have Not Previously Received a Bcl-2 or PI3K Inhibitor","A Phase 1b/2 Study of Duvelisib and Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Indolent or Aggressive Non-Hodgkin Lymphoma, Who Have Not Previously Received a Bcl-2 or PI3K Inhibitor",WITHDRAWN,,PHASE1,0.0,ACTUAL,AbbVie,,1.0,,Study Stopped,f,,,,f,,,,,,,,,,,,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,INDUSTRY,,,,,,,2021,0.0
NCT03952377,,2019-05-13,2023-10-24,,2023-12-19,2019-05-14,2019-05-16,ACTUAL,2023-12-19,2024-01-10,ACTUAL,,,,2023-12-19,2024-01-10,ACTUAL,2019-11-04,ACTUAL,2019-11-04,2023-12,2023-12-31,2022-06-21,ACTUAL,2022-06-21,2022-02-21,ACTUAL,2022-02-21,,INTERVENTIONAL,SALIENT,ITT Population,Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain,"A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase I/II, First-in-Human Study to Assess the Safety and Efficacy of Two Doses of SX600 Administered by Lumbosacral Transforaminal Epidural Injection in Patients With Radicular Pain Secondary to Lumbar Intervertebral Disc Herniation",TERMINATED,,PHASE1/PHASE2,56.0,ACTUAL,SpineThera Australia PTY LTD,"Due to the impact of COVID-19 and associated enrollment difficulties, the study was terminated with a total sample size of 56 randomized patients.",3.0,,"Due to the impact of COVID-19 and associated enrollment difficulties, the study was terminated with a total sample size of 56 randomized patients",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,INDUSTRY,,,,,,,2022,0.0
NCT02974803,,2016-11-23,2021-05-05,,2021-08-18,2016-11-23,2016-11-28,ESTIMATED,2021-07-22,2021-08-17,ACTUAL,,,,2021-08-18,2021-08-20,ACTUAL,2018-02-09,ACTUAL,2018-02-09,2021-07,2021-07-31,2020-07-29,ACTUAL,2020-07-29,2020-07-29,ACTUAL,2020-07-29,,INTERVENTIONAL,,,Concurrent Dabrafenib + Trametinib With Sterotactic Radiation in BRAF Mutation-Positive Malignant Melanoma and Brain Metastases,A Phase II Study of Concurrent Dabrafenib and Trametinib With Stereotactic Radiation in the Management of Patients With BRAF Mutation-Positive Malignant Melanoma and Brain Metastases,TERMINATED,,PHASE2,6.0,ACTUAL,Canadian Cancer Trials Group,,1.0,,Very slow accrual,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,NETWORK,,,,,,,2020,0.0
NCT04723589,,2020-11-26,,,2021-06-26,2021-01-22,2021-01-25,ACTUAL,,,,,,,2021-06-26,2021-06-30,ACTUAL,2021-04-30,ACTUAL,2021-04-30,2021-06,2021-06-30,2021-04-30,ACTUAL,2021-04-30,2021-04-30,ACTUAL,2021-04-30,,INTERVENTIONAL,RELIC,,Restoration of Endothelial Integrity in Patients With COVID-19 (RELIC),Restoration of Endothelial Integrity in Patients With COVID-19 (RELIC),WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Alabama at Birmingham,,2.0,,Widespread vaccine availability,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,OTHER,,,,,,,2021,0.0
NCT05029245,,2021-08-20,,,2022-05-05,2021-08-25,2021-08-31,ACTUAL,,,,,,,2022-05-05,2022-05-11,ACTUAL,2021-08-31,ESTIMATED,2021-08-31,2022-05,2022-05-31,2022-10-31,ESTIMATED,2022-10-31,2022-08-31,ESTIMATED,2022-08-31,,INTERVENTIONAL,PRIDE,,IntraDermal Versus Intramuscular Comirnaty® Efficacy Study,"The 8-week, Prospective, Randomized Controlled of IntraDermal Administration of Comirnaty® 6 Microgram Versus Intramuscular Comirnaty® 30 Microgram by 28 Days Interval Efficacy Study in Healthy Volunteer",WITHDRAWN,,PHASE3,0.0,ACTUAL,Rajavithi Hospital,,8.0,,No financial budget support,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,OTHER_GOV,,,,,,,2022,0.0
NCT03373461,,2017-11-30,2022-06-14,2021-07-07,2023-01-27,2017-12-13,2017-12-14,ACTUAL,2022-09-12,2022-10-07,ACTUAL,2022-09-12,2022-10-07,ACTUAL,2023-01-27,2023-01-30,ACTUAL,2018-02-07,ACTUAL,2018-02-07,2023-01,2023-01-31,2021-06-22,ACTUAL,2021-06-22,2020-12-29,ACTUAL,2020-12-29,,INTERVENTIONAL,,,Study of Safety and Efficacy of LNP023 in Patients With Kidney Disease Caused by Inflammation,"An Adaptive Seamless Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Investigate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients",COMPLETED,,PHASE2,112.0,ACTUAL,Novartis,,5.0,,,,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,INDUSTRY,,,,,,,2021,1.0
NCT03891264,,2019-03-25,2022-01-07,,2022-04-12,2019-03-25,2019-03-27,ACTUAL,2022-03-22,2022-04-13,ACTUAL,,,,2022-04-12,2022-05-04,ACTUAL,2019-11-13,ACTUAL,2019-11-13,2022-04,2022-04-30,2020-11-23,ACTUAL,2020-11-23,2020-11-23,ACTUAL,2020-11-23,,INTERVENTIONAL,CBD,,Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain,Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain,TERMINATED,,PHASE4,7.0,ACTUAL,Massachusetts General Hospital,,1.0,,Funding obtained to do a larger placebo-controlled trial,f,,,,f,t,f,,,t,,,Data will become available after 2 years,"Researchers, not for commercial use",,YES,We will make this data available upon request,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2020,0.0
NCT04412707,,2020-05-18,2022-05-30,,2023-02-09,2020-05-28,2020-06-02,ACTUAL,2022-07-18,2022-08-16,ACTUAL,,,,2023-02-09,2023-03-09,ACTUAL,2020-08-04,ACTUAL,2020-08-04,2023-01,2023-01-31,2022-01-10,ACTUAL,2022-01-10,2021-06-02,ACTUAL,2021-06-02,,INTERVENTIONAL,PORT,Full Analysis Set,"A PK, Safety and Tolerability Study of Peripheral and Central Infusion of Melflufen in RRMM Patients","A Randomized, Two-period, Cross-over, Phase 2 Study, Comparing Pharmacokinetics, and Assessing Safety and Tolerability of Peripheral and Central i.v. Administration of Melphalan Flufenamide (Melflufen) in RRMM Patients",TERMINATED,,PHASE2,27.0,ACTUAL,Oncopeptides AB,,2.0,,The sponsor decided to terminate the study following an FDA request of a partial clinical hold.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,INDUSTRY,,,,,,,2022,0.0
NCT02564978,,2015-09-30,2023-08-31,,2024-03-18,2015-09-30,2015-10-01,ESTIMATED,2024-01-03,2024-02-01,ACTUAL,,,,2024-03-18,2024-04-16,ACTUAL,2016-12-14,ACTUAL,2016-12-14,2022-09,2022-09-30,2023-03-08,ACTUAL,2023-03-08,2022-09-28,ACTUAL,2022-09-28,,INTERVENTIONAL,,,Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated With Age-Related Macular Degeneration,Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated With Age-Related Macular Degeneration,COMPLETED,,PHASE2,37.0,ACTUAL,National Institutes of Health Clinical Center (CC),"Potential disadvantages of study design (each participant eye serves as own control): long study period, requirement for participants to wait to begin treatment, and more complex interpretation of safety data. Potential limitations of study: discontinuation of study drug/study in number of participants (accounted for in sample size calculations), absence of assays to analyze microglial activity.",1.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,NIH,,,,,,,2023,1.0
NCT04402580,,2020-05-13,,,2020-09-10,2020-05-20,2020-05-27,ACTUAL,,,,,,,2020-09-10,2020-09-14,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2020-09,2020-09-30,2020-08-31,ACTUAL,2020-08-31,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,,,Efficacy of Anti-CD20 Antibodies (Rituximab Biosimilar) in the Treatment of Childhood Steroid-dependent Nephrotic Syndrome,Efficacy of Chimeric Monoclonal Anti-CD20 Antibodies (Rituximab Biosimilar) in the Treatment of Childhood Steroid-dependent Nephrotic Syndrome and Development of Cell Biomarkers Predicting Outcome. The RTX 4 Trial.,TERMINATED,,PHASE2,30.0,ACTUAL,Istituto Giannina Gaslini,,2.0,,due to unexpectedly high rate of relapse in the active comparator arm.,f,,,,t,f,f,,,,,,,,,YES,"The completed study will be summarized in a final report that accurately and completely presents the study objectives, methods, results, limitations of the study, and interpretation of findings.~The first publication will be an in extenso publication of the results of the validation of the project.~The Authors of this study protocol will inform the contributing investigators in advance about any plans to publish or present data from this randomized controlled clinical trial. Any publications and presentations of the results (abstract in journals or newspapers, oral presentations, etc.), either in whole or in part, by Investigators or their representatives will require pre-submission review by the Authors of this study protocol.",2024-10-16 12:04:24.881094,2024-10-16 12:04:24.881094,OTHER,,,,,,,2020,0.0
NCT04296578,,2020-03-03,,,2021-08-05,2020-03-03,2020-03-05,ACTUAL,,,,,,,2021-08-05,2021-08-12,ACTUAL,2020-10,ESTIMATED,2020-10-31,2020-09,2020-09-30,2023-10,ESTIMATED,2023-10-31,2022-10,ESTIMATED,2022-10-31,,INTERVENTIONAL,,,Study Evaluating Sodium Selenite in Combination With Abiraterone in Castrate Resistant Prostate Cancer Progressing on Abiraterone,A Phase 1 Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Abiraterone in Patients With Castrate Resistant Prostate Cancer Progressing on Abiraterone,WITHDRAWN,,PHASE1,0.0,ACTUAL,Stanford University,,6.0,,Study did not start,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,OTHER,,,,,,,2023,0.0
NCT04152083,,2019-11-02,2021-07-05,,2021-08-13,2019-11-02,2019-11-05,ACTUAL,2021-08-13,2021-08-16,ACTUAL,,,,2021-08-13,2021-08-17,ACTUAL,2019-11-07,ACTUAL,2019-11-07,2021-08,2021-08-31,2020-07-08,ACTUAL,2020-07-08,2020-07-08,ACTUAL,2020-07-08,,INTERVENTIONAL,RELIEF,Safety population included all participants who received eptinezumab or placebo.,A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine,"A Parallel Group, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Subjects Experiencing an Acute Attack of Migraine",COMPLETED,,PHASE3,485.0,ACTUAL,H. Lundbeck A/S,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,INDUSTRY,,,,,,,2020,1.0
NCT05029609,,2021-08-27,,,2022-02-14,2021-08-27,2021-08-31,ACTUAL,,,,,,,2022-02-14,2022-03-03,ACTUAL,2021-10,ESTIMATED,2021-10-31,2022-02,2022-02-28,2022-12,ESTIMATED,2022-12-31,2022-11,ESTIMATED,2022-11-30,,INTERVENTIONAL,,,Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS,"A Phase 1b, Double-Blind, Randomized, Placebo Controlled, Multiple Ascending Dose Study of the Safety, Tolerability and Immune Effects of the Intranasal Anti-CD3 Monoclonal Antibody Foralumab in Primary and Secondary Progressive MS",WITHDRAWN,,PHASE1,0.0,ACTUAL,Tiziana Life Sciences LTD,,4.0,,Withdrawn due to business reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:04:42.126578,2024-10-17 00:04:42.126578,INDUSTRY,,,,,,,2022,0.0
NCT04867785,,2021-04-29,2023-06-08,,2023-06-08,2021-04-29,2021-04-30,ACTUAL,2023-06-08,2023-07-03,ACTUAL,,,,2023-06-08,2023-07-03,ACTUAL,2021-05-13,ACTUAL,2021-05-13,2023-06,2023-06-30,2022-10-27,ACTUAL,2022-10-27,2022-07-08,ACTUAL,2022-07-08,,INTERVENTIONAL,,All randomized participants,A Study of LY3437943 in Participants With Type 2 Diabetes,A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo and Dulaglutide in Participants With Type 2 Diabetes,COMPLETED,,PHASE2,281.0,ACTUAL,Eli Lilly and Company,,8.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,INDUSTRY,,,,,,,2022,1.0
NCT06567457,,2023-08-23,,,2024-08-20,2024-08-20,2024-08-22,ACTUAL,,,,,,,2024-08-20,2024-08-22,ACTUAL,2023-10,ESTIMATED,2023-10-31,2024-08,2024-08-31,2024-10,ESTIMATED,2024-10-31,2024-09,ESTIMATED,2024-09-30,,INTERVENTIONAL,,,Immunogenicity and Safety Study of Monovalent Omicron XBB.1.5 Vaccine as a Booster in Adults,"Phase 3, Multi-center, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Monovalent Omicron XBB.1.5 Vaccine Administered as a Booster Dose to Adults Who Previously Received COVID-19 Vaccine",WITHDRAWN,,PHASE3,0.0,ACTUAL,Clover Biopharmaceuticals AUS Pty Ltd,,2.0,,varients of COVID-19 has changed,f,,,,t,f,f,,,,,,,,,,,2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,INDUSTRY,,,,,,,2024,0.0
NCT04652518,,2020-12-02,,2023-06-28,2024-02-12,2020-12-02,2020-12-03,ACTUAL,,,,,2024-02-14,ACTUAL,2024-02-12,2024-02-14,ACTUAL,2020-12-11,ACTUAL,2020-12-11,2023-10,2023-10-31,2022-07-18,ACTUAL,2022-07-18,2022-06-28,ACTUAL,2022-06-28,,INTERVENTIONAL,,,LYT-100 in Post-acute COVID-19 Respiratory Disease,"A Phase 2 Randomized, Double-blind, Placebo-controlled Trial and Open Label Extension to Evaluate the Safety and Efficacy of Deupirfenidone (LYT-100) in Post-acute COVID-19 Respiratory Disease",TERMINATED,,PHASE2,185.0,ACTUAL,PureTech,,3.0,,Part A of the study was completed; Part B of the study was terminated,f,,,,t,t,f,,,,,,,,,,,2024-10-17 00:11:29.349696,2024-10-17 00:11:29.349696,INDUSTRY,,,,,,,2022,0.0
NCT03782402,,2018-12-18,2022-08-02,,2023-01-03,2018-12-18,2018-12-20,ACTUAL,2023-01-03,2023-01-26,ACTUAL,,,,2023-01-03,2023-01-26,ACTUAL,2019-09-01,ACTUAL,2019-09-01,2022-11,2022-11-30,2021-08-30,ACTUAL,2021-08-30,2021-08-30,ACTUAL,2021-08-30,,INTERVENTIONAL,,,Cannabinoids for Taxane Induced Peripheral Neuropathy,The Effect of Dispensed Cannabis on Taxane Induced Peripheral Neuropathy,TERMINATED,,PHASE2,12.0,ACTUAL,New York State Psychiatric Institute,Please note: this was a pilot study that was not funded for a full study.,2.0,,Funding being sought,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,OTHER,,,,,,,2021,0.0
NCT02304302,,2014-11-24,2021-12-22,,2023-05-31,2014-11-25,2014-12-01,ESTIMATED,2022-04-04,2022-04-05,ACTUAL,,,,2023-05-31,2023-06-27,ACTUAL,2014-10,,2014-10-31,2022-04,2022-04-30,2020-07-22,ACTUAL,2020-07-22,2020-07-22,ACTUAL,2020-07-22,,INTERVENTIONAL,,,Down Syndrome Memantine Follow-up Study,"Phase II Multicenter 16-Week Randomized Double Blind Placebo-Controlled Evaluation of the Efficacy, Tolerability and Safety of Memantine Hydrochloride on Enhancing the Cognitive Abilities of Adolescents and Young Adults With Down Syndrome",COMPLETED,,PHASE2,160.0,ACTUAL,University Hospitals Cleveland Medical Center,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,OTHER,,,,,,,2020,1.0
NCT04282590,,2020-02-17,,,2022-02-27,2020-02-20,2020-02-25,ACTUAL,,,,,,,2022-02-27,2022-03-15,ACTUAL,2020-04,ESTIMATED,2020-04-30,2022-02,2022-02-28,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,A Study to Investigate the Safety and Efficacy of TRK-750 for the Treatment of Patients With CIPN (Chopin Study),"A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TRK-750 in Colorectal Cancer Patients With Chemotherapy-induced Peripheral Neuropathy Following Oxaliplatin-containing Chemotherapy in the Adjuvant Setting",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Toray Industries, Inc",,2.0,,due to COVID-19 pandemic,f,,,,f,f,f,,,,,,,,,,,2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,INDUSTRY,,,,,,,2021,0.0
NCT02432209,,2015-03-16,2021-01-15,,2022-02-01,2015-05-01,2015-05-04,ESTIMATED,2021-02-19,2021-03-15,ACTUAL,,,,2022-02-01,2022-02-03,ACTUAL,2015-08,ACTUAL,2015-08-31,2022-02,2022-02-28,2020-05,ACTUAL,2020-05-31,2019-11-30,ACTUAL,2019-11-30,,INTERVENTIONAL,FIT-PLESE,,Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility,Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility,COMPLETED,,PHASE3,379.0,ACTUAL,Yale University,,2.0,,,f,,,,t,,,,,,,,,,,YES,IPD will be shared with other researchers through the NICHD DASH system. It will be available 6 months after publication of the primary results.,2024-10-17 00:11:29.349696,2024-10-17 00:11:29.349696,OTHER,,,,,,,2020,1.0
NCT04845321,,2021-04-10,,,2022-06-14,2021-04-10,2021-04-14,ACTUAL,,,,,,,2022-06-14,2022-06-21,ACTUAL,2021-06-23,ACTUAL,2021-06-23,2022-06,2022-06-30,2021-10-31,ACTUAL,2021-10-31,2021-10-31,ACTUAL,2021-10-31,,INTERVENTIONAL,,,VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers,Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of VNRX-9945 in Healthy Adult Volunteers,TERMINATED,,PHASE1,32.0,ACTUAL,"Venatorx Pharmaceuticals, Inc.",,2.0,,"Part 2 terminated, unrelated to safety.",f,,,,,f,f,,,,,,,,,,,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,INDUSTRY,,,,,,,2021,0.0
NCT03829657,,2019-01-10,2022-11-08,,2022-12-29,2019-01-31,2019-02-04,ACTUAL,2022-12-29,2023-01-20,ACTUAL,,,,2022-12-29,2023-01-20,ACTUAL,2019-02-22,ACTUAL,2019-02-22,2022-12,2022-12-31,2021-11-10,ACTUAL,2021-11-10,2021-11-10,ACTUAL,2021-11-10,,INTERVENTIONAL,REDWOOD,OL Treatment Period Safety Analysis Set: all enrolled participants who received at least 1 dose of ampreloxetine during the OL period.,Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure,"A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure",TERMINATED,,PHASE3,203.0,ACTUAL,Theravance Biopharma,De Novo participants in the OL treatment period had limited follow-up due to early termination of the study.,3.0,,Stopped early due to company decision. Company decision based on analysis results in TD-9855-0169.,f,,,,t,t,f,,,,,,,,,NO,"Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.",2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,INDUSTRY,,,,,,,2021,0.0
NCT04371666,,2020-04-29,2024-02-13,,2024-02-13,2020-04-29,2020-05-01,ACTUAL,2024-02-13,2024-03-12,ACTUAL,,,,2024-02-13,2024-03-12,ACTUAL,2020-08-10,ACTUAL,2020-08-10,2024-02,2024-02-29,2023-08-17,ACTUAL,2023-08-17,2023-02-13,ACTUAL,2023-02-13,,INTERVENTIONAL,LELANTOS-1,The intent-to-treat (ITT) set included all randomized participants.,Phase 3 Trial of Pamrevlumab or Placebo With Systemic Corticosteroids in Participants With Non-ambulatory Duchenne Muscular Dystrophy (DMD),"A Phase 3, Randomized, Double-Blind Trial of Pamrevlumab (FG-3019) or Placebo in Combination With Systemic Corticosteroids in Subjects With Non-ambulatory Duchenne Muscular Dystrophy (DMD)",TERMINATED,,PHASE3,98.0,ACTUAL,FibroGen,,2.0,,Study did not meet its primary endpoint.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,INDUSTRY,,,,,,,2023,0.0
NCT04768881,,2021-02-22,2024-07-25,,2024-08-22,2021-02-22,2021-02-24,ACTUAL,2024-08-22,2024-08-23,ACTUAL,,,,2024-08-22,2024-08-23,ACTUAL,2021-05-12,ACTUAL,2021-05-12,2024-08,2024-08-31,2023-09-22,ACTUAL,2023-09-22,2023-09-22,ACTUAL,2023-09-22,,INTERVENTIONAL,,Modified intent-to-treat (mITT) population consisted of all participants who received at least one dose of any study treatment.,Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma,A Phase 2 Open-Label Multicenter Study to Evaluate the Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma,TERMINATED,,PHASE2,15.0,ACTUAL,Karyopharm Therapeutics Inc,This study was stopped prematurely due to a lack of sufficient anti-tumor signal for the selinexor/pembrolizumab combination treatment in participants with advanced or metastatic melanoma.,2.0,,The trial was terminated due to a lack of sufficient anti-melanoma tumor signal for the combination of selinexor + pembrolizumab.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,INDUSTRY,,,,,,,2023,0.0
NCT03338205,,2017-11-01,,,2024-02-02,2017-11-08,2017-11-09,ACTUAL,,,,,,,2024-02-02,2024-02-06,ACTUAL,2020-01,ESTIMATED,2020-01-31,2024-02,2024-02-29,2022-01,ESTIMATED,2022-01-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus,The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus in Pediatric Emergency Medicine Patients: A Pilot Study,WITHDRAWN,,PHASE3,0.0,ACTUAL,Augusta University,,1.0,,Unable to enroll patients,,,,,t,t,f,,,,,,,,,,,2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,OTHER,,,,,,,2022,0.0
NCT02178358,,2014-06-12,2020-10-05,2018-06-05,2022-02-14,2014-06-26,2014-06-30,ESTIMATED,2020-11-06,2020-12-02,ACTUAL,2018-06-05,2018-06-08,ACTUAL,2022-02-14,2022-02-25,ACTUAL,2014-08-08,ACTUAL,2014-08-08,2022-02,2022-02-28,2021-02-18,ACTUAL,2021-02-18,2017-06-30,ACTUAL,2017-06-30,,INTERVENTIONAL,,All randomized participants.,A Study of LY2157299 in Participants With Advanced Hepatocellular Carcinoma,A Randomized Phase 2 Study of LY2157299 Versus LY2157299 - Sorafenib Combination Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma,COMPLETED,,PHASE2,132.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,f,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and european union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-17 00:11:29.349696,2024-10-17 00:11:29.349696,INDUSTRY,,,,,,,2021,1.0
NCT04109742,,2019-09-23,,,2021-09-21,2019-09-27,2019-09-30,ACTUAL,,,,,,,2021-09-21,2021-09-27,ACTUAL,2019-12-09,ACTUAL,2019-12-09,2021-09,2021-09-30,2020-04-22,ACTUAL,2020-04-22,2020-04-22,ACTUAL,2020-04-22,,INTERVENTIONAL,,,Curcumin for Pediatric Nonalcoholic Fatty Liver Disease,Curcumin for Pediatric Nonalcoholic Fatty Liver Disease: A Pilot Randomized Controlled Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,Columbia University,,3.0,,Lack of funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,OTHER,,,,,,,2020,0.0
NCT01905592,,2013-07-18,2020-01-29,,2022-10-21,2013-07-18,2013-07-23,ESTIMATED,2020-08-10,2020-08-27,ACTUAL,,,,2022-10-21,2022-11-15,ACTUAL,2014-02-25,ACTUAL,2014-02-25,2022-10,2022-10-31,2021-10-26,ACTUAL,2021-10-26,2018-05-23,ACTUAL,2018-05-23,,INTERVENTIONAL,BRAVO,The centrally-confirmed intent-to-treat population is defined as all randomized participants with a central confirmation of germline BRCA mutation.,"A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients","A Phase III, Randomized, Open Label, Multicenter, Controlled Trial of Niraparib Versus Physician's Choice in Previously-treated, HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients",TERMINATED,,PHASE3,216.0,ACTUAL,"Tesaro, Inc.","IDMC interim analysis concluded that concerns with the quantity and quality of data in the control arm precluded meaningful comparative analyses and generation of a clinically useful endpoint, therefore enrollment was ended prematurely.",2.0,,The study was terminated due to futility.,f,,,,t,t,,,,,,,,,,NO,,2024-10-17 00:11:29.349696,2024-10-17 00:11:29.349696,INDUSTRY,,,,,,,2021,0.0
NCT03901469,,2019-03-22,,,2024-05-01,2019-04-01,2019-04-03,ACTUAL,,,,,,,2024-05-01,2024-05-03,ACTUAL,2019-06-26,ACTUAL,2019-06-26,2024-05,2024-05-31,2024-03-07,ACTUAL,2024-03-07,2024-03-07,ACTUAL,2024-03-07,,INTERVENTIONAL,TNBC,,A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer,A Phase 2b Study of ZEN003694 in Combination With Talazoparib in Patients With Triple-Negative Breast Cancer,TERMINATED,,PHASE2,115.0,ACTUAL,Zenith Epigenetics,,4.0,,Parts 1 and 2 and Expansion Cohort C were completed. Expansion Cohorts A and B were discontinued based on results from an interim futility analysis and not due to safety concerns.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,INDUSTRY,,,,,,,2024,0.0
NCT02873195,,2016-08-16,2020-01-23,,2024-07-30,2016-08-16,2016-08-19,ESTIMATED,2020-01-23,2020-02-05,ACTUAL,,,,2024-07-30,2024-08-23,ACTUAL,2017-07-07,ACTUAL,2017-07-07,2024-07,2024-07-31,2023-12-01,ACTUAL,2023-12-01,2023-03-06,ACTUAL,2023-03-06,,INTERVENTIONAL,,,Capecitabine and Bevacizumab With or Without Atezolizumab in Treating Patients With Refractory Metastatic Colorectal Cancer,"BACCI: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Capecitabine Bevacizumab Plus Atezolizumab Versus Capecitabine Bevacizumab Plus Placebo in Patients With Refractory Metastatic Colorectal Cancer",COMPLETED,,PHASE2,133.0,ACTUAL,Academic and Community Cancer Research United,,2.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,OTHER,,,,,,,2023,1.0
NCT04163991,,2019-11-12,2022-12-16,,2023-01-17,2019-11-12,2019-11-15,ACTUAL,2023-01-17,2023-02-14,ACTUAL,,,,2023-01-17,2023-02-14,ACTUAL,2019-12-09,ACTUAL,2019-12-09,2023-01,2023-01-31,2021-12-28,ACTUAL,2021-12-28,2021-12-28,ACTUAL,2021-12-28,,INTERVENTIONAL,MIDORA,"Full Analysis Set: all randomized participants who received any dose of study drug, analyzed according to the treatment randomized.",A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of the Efficacy and Safety of VIB4920 in Patients With Rheumatoid Arthritis (RA)",COMPLETED,,PHASE2,78.0,ACTUAL,Viela Bio (acquired by Horizon Therapeutics),,5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,INDUSTRY,,,,,,,2021,1.0
NCT02105636,,2014-04-03,2016-11-15,2016-07-28,2022-09-06,2014-04-04,2014-04-07,ESTIMATED,2016-11-15,2017-01-11,ESTIMATED,2016-07-28,2016-08-01,ESTIMATED,2022-09-06,2022-10-05,ACTUAL,2014-05-29,ACTUAL,2014-05-29,2022-08,2022-08-31,2021-09-10,ACTUAL,2021-09-10,2015-11-06,ACTUAL,2015-11-06,,INTERVENTIONAL,,,Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141),"An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)",COMPLETED,,PHASE3,361.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,INDUSTRY,,,,,,,2021,1.0
NCT05352815,,2022-04-24,,,2024-06-24,2022-04-24,2022-04-29,ACTUAL,,,,,,,2024-06-24,2024-06-25,ACTUAL,2022-06-01,ACTUAL,2022-06-01,2024-06,2024-06-30,2024-04-23,ACTUAL,2024-04-23,2024-03-18,ACTUAL,2024-03-18,,INTERVENTIONAL,COMBINE 1,,"A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec","A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Insulin Icodec, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin.",COMPLETED,,PHASE3,1291.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 02:41:50.457756,2024-10-16 02:41:50.457756,INDUSTRY,,,,,,,2024,1.0
NCT05643729,,2022-11-01,,,2023-10-30,2022-12-06,2022-12-09,ACTUAL,,,,,,,2023-10-30,2023-11-01,ACTUAL,2023-11-15,ESTIMATED,2023-11-15,2022-10,2022-10-31,2024-08-31,ESTIMATED,2024-08-31,2024-05-30,ESTIMATED,2024-05-30,,INTERVENTIONAL,,,Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD),"A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion (IV) of ZofinTM for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)",SUSPENDED,,PHASE1/PHASE2,20.0,ESTIMATED,"ZEO ScientifiX, Inc.",,2.0,,Study is on hold,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:11:29.349696,2024-10-17 00:11:29.349696,INDUSTRY,,,,,,,2024,0.0
NCT04762771,,2021-02-18,2022-02-25,,2022-07-21,2021-02-18,2021-02-21,ACTUAL,2022-03-10,2022-03-14,ACTUAL,,,,2022-07-21,2022-07-25,ACTUAL,2020-12-23,ACTUAL,2020-12-23,2022-07,2022-07-31,2021-09-20,ACTUAL,2021-09-20,2021-05-12,ACTUAL,2021-05-12,,INTERVENTIONAL,Colheart-19,,Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19),Open-label (Unblinded) Randomization to Treatment of Colchicine Plus Current Care Per Institution Treating Physicians vs. Current Care Per Institution Treating Physicians (Control Arm),TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,Baptist Health South Florida,"The rapid decline in COVID patients and other competing trials did not allowed enrollment of additional subjects. Given the small sample size, the study was terminated.",2.0,,Recovery Trial showed no convincing evidence that further recruitment would provide conclusive proof of worthwhile benefit for the evaluation of Colchicine in patients with Covid-19.,f,,,,,t,f,,,,,,,,,,,2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,OTHER,,,,,,,2021,0.0
NCT05012397,,2021-08-13,,,2023-10-16,2021-08-13,2021-08-19,ACTUAL,,,,,,,2023-10-16,2023-10-18,ACTUAL,2021-11-01,ACTUAL,2021-11-01,2023-08,2023-08-31,2023-10-15,ACTUAL,2023-10-15,2023-10-15,ACTUAL,2023-10-15,,INTERVENTIONAL,,,Milademetan in Advanced/Metastatic Solid Tumors,A Phase 2 Basket Study of Milademetan in Advanced/Metastatic Solid Tumors (MANTRA-2),TERMINATED,,PHASE2,40.0,ACTUAL,Rain Oncology Inc,,1.0,,Sponsor Decision,f,,,,,t,f,,,,,,,,,NO,,2024-10-17 00:11:29.349696,2024-10-17 00:11:29.349696,INDUSTRY,,,,,,,2023,0.0
NCT04888858,,2021-05-06,,,2023-09-21,2021-05-11,2021-05-17,ACTUAL,,,,,,,2023-09-21,2023-09-25,ACTUAL,2020-11-02,ACTUAL,2020-11-02,2023-09,2023-09-30,2022-07-02,ACTUAL,2022-07-02,2022-07-02,ACTUAL,2022-07-02,,INTERVENTIONAL,,,Effect of Epidural Analgesia During Labor on Force of Maternal Push,Effect of Epidural Analgesia During Labor on Force of Maternal Push,WITHDRAWN,,PHASE4,0.0,ACTUAL,Henry Ford Health System,,1.0,,"The PI, Dr. Younger, left Henry Ford Health.",f,,,,f,t,f,,,,,,,,,NO,There is not a plan to share individual participant data with other researchers.,2024-10-17 00:11:29.349696,2024-10-17 00:11:29.349696,OTHER,,,,,,,2022,0.0
NCT03725722,,2018-10-30,2021-05-07,,2024-07-30,2018-10-30,2018-10-31,ACTUAL,2021-07-06,2021-07-08,ACTUAL,,,,2024-07-30,2024-08-22,ACTUAL,2018-12-28,ACTUAL,2018-12-28,2021-06,2021-06-30,2020-05-19,ACTUAL,2020-05-19,2020-05-19,ACTUAL,2020-05-19,,INTERVENTIONAL,,Number of subjects randomized,"Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over an 8-week Treatment Period in Adult Subjects With Atopic Dermatitis.","A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose Ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Applications of Delgocitinib Cream 1, 3, 8, 20 mg/g for 8 Weeks in Adult Subjects With Mild to Severe Atopic Dermatitis.",COMPLETED,,PHASE2,251.0,ACTUAL,LEO Pharma,,5.0,,,f,,,,f,t,f,,,,,,,De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.,https://www.leopharmatrials.com/for-researchers,YES,,2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,INDUSTRY,,,,,,,2020,1.0
NCT03523728,,2018-05-01,2022-07-29,,2023-02-01,2018-05-01,2018-05-14,ACTUAL,2022-10-18,2022-11-09,ACTUAL,,,,2023-02-01,2023-02-03,ACTUAL,2018-10-04,ACTUAL,2018-10-04,2023-02,2023-02-28,2021-08-03,ACTUAL,2021-08-03,2021-08-03,ACTUAL,2021-08-03,,INTERVENTIONAL,STAGED-PKD,Analysis was performed on all participants randomized in the study.,A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients,"Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)",TERMINATED,,PHASE2/PHASE3,478.0,ACTUAL,Sanofi,"Following decision to discontinue EFC15392 based on the futility analysis, the two-steps analysis initially planned were not applicable, therefore only the final analysis of all safety endpoints (laboratory, vital sign, ECG, physical examination, BDI-II, and lens opacity) were performed on extended combined Stage 1 and Stage 2 safety population only.",5.0,,Interim analysis for futility of the Stage 1 of the EFC15392 study met the protocol specified stopping rule based on the primary endpoint. EFC15392 study was stopped for futility based on prespecified criteria and recommendation from DMC,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,INDUSTRY,,,,,,,2021,0.0
NCT03823404,,2019-01-24,2022-12-23,,2023-02-22,2019-01-29,2019-01-30,ACTUAL,2023-02-22,2023-02-23,ACTUAL,,,,2023-02-22,2023-02-23,ACTUAL,2019-03-28,ACTUAL,2019-03-28,2023-01,2023-01-31,2022-01-01,ACTUAL,2022-01-01,2022-01-01,ACTUAL,2022-01-01,,INTERVENTIONAL,,Safety Population,GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease,"GAIN Trial: A Randomized, Double-Blind, Placebo-Controlled Study of COR388 in Subjects With Alzheimer's Disease",COMPLETED,,PHASE2/PHASE3,643.0,ACTUAL,Cortexyme Inc.,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,INDUSTRY,,,,,,,2022,1.0
NCT03231397,,2017-06-22,2021-04-23,,2021-06-17,2017-07-25,2017-07-27,ACTUAL,2021-06-17,2021-07-09,ACTUAL,,,,2021-06-17,2021-07-09,ACTUAL,2017-08-01,ACTUAL,2017-08-01,2021-06,2021-06-30,2020-04-30,ACTUAL,2020-04-30,2020-04-30,ACTUAL,2020-04-30,,INTERVENTIONAL,,We were unable to enroll subjects in the control group and the AAA's undergoing treatment who met the inclusion/exclusion criteria.,Predictors of AAA Expansion and/or Rupture,Noninvasive Assessment of Abdominal Aortic Aneurysm (AAA) Wall Structural Integrity and Inflammation as Predictors of Expansion and/or Rupture,TERMINATED,,PHASE4,2.0,ACTUAL,Washington University School of Medicine,,4.0,,We were unable to recruit more subjects who met the inclusion/exclusion criteria and we have closed the study.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 00:11:29.349696,2024-10-17 00:11:29.349696,OTHER,,,,,,,2020,0.0
NCT04114656,,2019-09-12,2022-09-05,,2023-09-08,2019-10-01,2019-10-03,ACTUAL,2022-09-05,2023-08-01,ACTUAL,,,,2023-09-08,2024-03-18,ACTUAL,2019-10-15,ACTUAL,2019-10-15,2023-09,2023-09-30,2021-09-16,ACTUAL,2021-09-16,2021-09-16,ACTUAL,2021-09-16,,INTERVENTIONAL,,,Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers,"A Randomized, Double-blind, Placebo-controlled, Three-period Two-treatment Incomplete-block Crossover Study to Investigate the Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Participants",TERMINATED,,PHASE1,21.0,ACTUAL,GlaxoSmithKline,,2.0,,This study was terminated due to meeting protocol defined futility.,f,,,,f,f,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-17 00:11:29.349696,2024-10-17 00:11:29.349696,INDUSTRY,,,,,,,2021,0.0
NCT04712721,,2020-12-11,,,2024-07-16,2021-01-14,2021-01-15,ACTUAL,,,,,,,2024-07-16,2024-07-18,ACTUAL,2021-10-14,ACTUAL,2021-10-14,2024-07,2024-07-31,2024-07-01,ACTUAL,2024-07-01,2024-06-18,ACTUAL,2024-06-18,,INTERVENTIONAL,,,Study of [68Ga]-FF58 in Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.,"Phase I, Open-label, Multicenter Study to Evaluate the Imaging Performance, Safety, Biodistribution and Dosimetry of [68Ga]-FF58 in Adult Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.",TERMINATED,,EARLY_PHASE1,14.0,ACTUAL,Novartis,,4.0,,Business reasons,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,INDUSTRY,,,,,,,2024,0.0
NCT03170271,,2017-05-26,2020-09-24,,2021-10-20,2017-05-26,2017-05-31,ACTUAL,2020-11-20,2020-12-16,ACTUAL,,,,2021-10-20,2021-11-01,ACTUAL,2017-07-07,ACTUAL,2017-07-07,2021-10,2021-10-31,2020-10-21,ACTUAL,2020-10-21,2019-09-25,ACTUAL,2019-09-25,,INTERVENTIONAL,ANDHI,All patients in the full analysis set (FAS) who received any investigational product (IP) were included in the baseline analysis.,A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma.,"A Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients With Severe Asthma Uncontrolled on Standard of Care Treatment",COMPLETED,,PHASE3,660.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,,2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,INDUSTRY,,,,,,,2020,1.0
NCT03043651,,2017-01-31,2020-09-25,,2020-09-25,2017-02-02,2017-02-06,ESTIMATED,2020-09-25,2020-10-22,ACTUAL,,,,2020-09-25,2020-10-22,ACTUAL,2018-01-30,ACTUAL,2018-01-30,2020-09,2020-09-30,2020-03-02,ACTUAL,2020-03-02,2020-03-02,ACTUAL,2020-03-02,,INTERVENTIONAL,,All Subjects,Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF,An Open-label Extension Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF) - A Long-term Follow-up to Study TDE-HF-301,TERMINATED,,PHASE3,48.0,ACTUAL,United Therapeutics,,1.0,,Terminated by Sponsor,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,INDUSTRY,,,,,,,2020,0.0
NCT03762681,,2018-11-30,2021-03-16,,2021-04-20,2018-11-30,2018-12-04,ACTUAL,2021-03-16,2021-04-09,ACTUAL,,,,2021-04-20,2021-05-11,ACTUAL,2018-12-14,ACTUAL,2018-12-14,2021-04,2021-04-30,2020-04-06,ACTUAL,2020-04-06,2020-04-06,ACTUAL,2020-04-06,,INTERVENTIONAL,,Safety population included all study participants who received at least one dose of RO7239958 or placebo.,"A Study of RO7239958 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection","A Randomized, Placebo-controlled,Observer-blinded Study, to Evaluate Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of RO7239958 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection",TERMINATED,,PHASE1,55.0,ACTUAL,Hoffmann-La Roche,,3.0,,The study was terminated due to program discontinuation.,f,,,,,f,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-17 00:11:29.349696,2024-10-17 00:11:29.349696,INDUSTRY,,,,,,,2020,0.0
NCT04854434,,2021-04-17,2023-07-31,,2023-10-10,2021-04-17,2021-04-22,ACTUAL,2023-10-10,2023-11-03,ACTUAL,,,,2023-10-10,2023-11-03,ACTUAL,2021-06-29,ACTUAL,2021-06-29,2023-10,2023-10-31,2022-06-24,ACTUAL,2022-06-24,2022-06-24,ACTUAL,2022-06-24,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations,A Phase 2 Open-Label Multicenter Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations,TERMINATED,,PHASE2,13.0,ACTUAL,Karyopharm Therapeutics Inc,"Prior to study completion, the signal was assessed by sponsor to be uncompetitive in the current treatment landscape and thus CRC program was closed. Thereby some of the protocol planned analysis were not performed and thus no data was reported for those outcome measures.",3.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,INDUSTRY,,,,,,,2022,0.0
NCT03029143,,2017-01-20,2021-10-15,,2023-07-20,2017-01-20,2017-01-24,ESTIMATED,2021-10-15,2021-11-11,ACTUAL,,,,2023-07-20,2023-07-28,ACTUAL,2017-03-29,ACTUAL,2017-03-29,2023-07,2023-07-31,2020-10-16,ACTUAL,2020-10-16,2020-10-16,ACTUAL,2020-10-16,,INTERVENTIONAL,ENTERPRET,Safety analysis set Included all participants who were enrolled and received at least one dose of study medication.,Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis,A Phase 4 Open-Label Study to Evaluate Vedolizumab IV Dose Optimization on Treatment Outcomes In Nonresponders With Moderately to Severely Active Ulcerative Colitis (ENTERPRET),COMPLETED,,PHASE4,278.0,ACTUAL,Takeda,,3.0,,,f,,,,f,t,f,,,f,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,INDUSTRY,,,,,,,2020,1.0
NCT04682639,,2020-12-19,2023-09-29,,2024-05-02,2020-12-19,2020-12-24,ACTUAL,2023-09-29,2023-10-26,ACTUAL,,,,2024-05-02,2024-05-06,ACTUAL,2020-12-15,ACTUAL,2020-12-15,2024-05,2024-05-31,2023-06-30,ACTUAL,2023-06-30,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,VOYAGE,All participants who were randomized to study treatment.,A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects With Eosinophilic Esophagitis",COMPLETED,,PHASE2,108.0,ACTUAL,Pfizer,,3.0,,,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,INDUSTRY,,,,,,,2023,1.0
NCT02530437,,2015-08-19,2023-02-14,2023-01-06,2023-07-07,2015-08-19,2015-08-21,ESTIMATED,2023-07-07,2023-07-10,ACTUAL,,2023-07-10,ACTUAL,2023-07-07,2023-07-10,ACTUAL,2017-03-07,ACTUAL,2017-03-07,2023-07,2023-07-31,2022-01-07,ACTUAL,2022-01-07,2022-01-07,ACTUAL,2022-01-07,,INTERVENTIONAL,,,"Taladegib, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Localized Esophageal or Gastroesophageal Junction Cancer","A Phase 1B/2 Study of Taladegib in Combination With Weekly Paclitaxel, Carboplatin, and Radiation in Localized Adenocarcinoma of the Esophagus or Gastroesophageal Junction",TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,The sponsor sold the drug TALADEGIB to another company during the trial and thereafter no drug was available. The sponsor made a decision to stop development of this drug Taladegib.,f,,,,f,t,f,,,,,,,,,,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,OTHER,,,,,,,2022,0.0
NCT03186417,,2017-06-12,,,2023-06-22,2017-06-12,2017-06-14,ACTUAL,,,,,,,2023-06-22,2023-06-23,ACTUAL,2017-12-15,ACTUAL,2017-12-15,2023-06,2023-06-30,2023-05-31,ACTUAL,2023-05-31,2023-04-30,ACTUAL,2023-04-30,,INTERVENTIONAL,,,Mesenchymal Stem Cells in Early Rheumatoid Arthritis,Cell-Based Therapy in Rheumatoid Arthritis: Proof of Concept Phase 1 Trial,TERMINATED,,PHASE1,10.0,ACTUAL,MetroHealth Medical Center,,3.0,,slow enrollment during covid and lack of funds to continue,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,OTHER,,,,,,,2023,0.0
NCT03697720,,2018-10-04,2023-09-27,,2023-09-27,2018-10-04,2018-10-05,ACTUAL,2023-09-27,2023-10-18,ACTUAL,,,,2023-09-27,2023-10-18,ACTUAL,2018-05-09,ACTUAL,2018-05-09,2023-09,2023-09-30,2023-09-27,ACTUAL,2023-09-27,2020-11-23,ACTUAL,2020-11-23,,INTERVENTIONAL,,,Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain,Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain,COMPLETED,,PHASE4,26.0,ACTUAL,NorthShore University HealthSystem,There was some loss to follow-up. We did not systematically query for adverse events.,1.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,OTHER,,,,,,,2023,1.0
NCT03703102,,2018-10-09,2022-03-22,2021-02-02,2024-04-24,2018-10-09,2018-10-11,ACTUAL,2022-05-13,2022-06-09,ACTUAL,2022-05-13,2022-06-09,ACTUAL,2024-04-24,2024-04-26,ACTUAL,2018-10-22,ACTUAL,2018-10-22,2024-04,2024-04-30,2020-11-12,ACTUAL,2020-11-12,2020-02-06,ACTUAL,2020-02-06,,INTERVENTIONAL,,One subject who was randomized to the 600 mg Q4W group did not receive any study treatment due to consent withdrawal before the start of the treatment. They are not included in baseline or any of the analysis sets.,Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis,"A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis (AD)",COMPLETED,,PHASE2,274.0,ACTUAL,"Kyowa Kirin Co., Ltd.",,5.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,INDUSTRY,,,,,,,2020,1.0
NCT04044742,,2019-08-02,,,2021-11-02,2019-08-02,2019-08-05,ACTUAL,,,,,,,2021-11-02,2021-11-09,ACTUAL,2020-12,ESTIMATED,2020-12-31,2021-11,2021-11-30,2023-03,ESTIMATED,2023-03-31,2023-03,ESTIMATED,2023-03-31,,INTERVENTIONAL,,,A Phase 3 Study to Evaluate the Efficacy and Safety of Resiniferatoxin for Pain Due to Osteoarthritis of the Knee,A Phase 3 Placebo-controlled Study to Evaluate the Efficacy and Safety of Intra-articular Administration of Resiniferatoxin Versus Placebo for the Treatment of Moderate to Severe Pain Due to Osteoarthritis of the Knee,WITHDRAWN,,PHASE3,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,2.0,,To be replaced by a different protocol,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,INDUSTRY,,,,,,,2023,0.0
NCT04223843,,2020-01-07,2021-09-07,,2021-10-20,2020-01-08,2020-01-10,ACTUAL,2021-10-20,2021-11-18,ACTUAL,,,,2021-10-20,2021-11-18,ACTUAL,2020-01-08,ACTUAL,2020-01-08,2021-10,2021-10-31,2020-09-29,ACTUAL,2020-09-29,2020-09-07,ACTUAL,2020-09-07,,INTERVENTIONAL,,"Treated Set (TS): This patient set included all randomised patients who were dispensed trial medication and were documented to have taken any dose of trial medication. The TS was used for demographics and baseline disease characteristics, concomitant therapies, treatment exposure, and safety analysis.",A Study to Test the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler in People With Chronic Obstructive Pulmonary Disease (COPD) Who Have Different Abilities to Inhale,"A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Group Study to Compare the Efficacy of Inhaled Tiotropium + Olodaterol, Fixed Dose Combination (5 mcg/5mcg) vs. Placebo Delivered by Respimat Inhaler in Patients With Moderate to Severe COPD, Stratified by Peak Inspiratory Flow Rate [TRONARTO].",COMPLETED,,PHASE4,213.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,f,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.",2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,INDUSTRY,,,,,,,2020,1.0
NCT04003623,,2019-06-25,2022-03-29,,2022-04-21,2019-06-28,2019-07-01,ACTUAL,2022-03-29,2022-04-21,ACTUAL,,,,2022-04-21,2022-05-10,ACTUAL,2019-10-31,ACTUAL,2019-10-31,2022-04,2022-04-30,2020-06-12,ACTUAL,2020-06-12,2020-06-12,ACTUAL,2020-06-12,,INTERVENTIONAL,,No participants were enrolled in Cohort B.,Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208),"A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumors Harboring Activating FGFR Mutations or Translocations (FIGHT-208)",TERMINATED,,PHASE2,1.0,ACTUAL,Incyte Corporation,"The Sponsor made a decision unrelated to safety to halt study enrollment. Due to early termination of the study with only1 participant, no analysis of efficacy endpoints was done.",1.0,,The study was closed due to lack of enrollment.,f,,,,f,t,f,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency,2024-10-17 00:11:29.349696,2024-10-17 00:11:29.349696,INDUSTRY,,,,,,,2020,0.0
NCT05492695,,2022-08-05,,,2023-09-28,2022-08-05,2022-08-08,ACTUAL,,,,,,,2023-09-28,2023-09-29,ACTUAL,2022-10-01,ACTUAL,2022-10-01,2023-09,2023-09-30,2023-09-28,ACTUAL,2023-09-28,2023-09-28,ACTUAL,2023-09-28,,INTERVENTIONAL,TOGETHER,,Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study,TOGETHER STUDY: Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study,TERMINATED,,PHASE4,2.0,ACTUAL,Diamond Headache Clinic,,2.0,,Stopped from financial sponsor due to inability to enroll participants.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,OTHER,,,,,,,2023,0.0
NCT03613792,,2018-07-30,,,2023-07-25,2018-08-02,2018-08-03,ACTUAL,,,,,,,2023-07-25,2023-07-27,ACTUAL,2023-09,ESTIMATED,2023-09-30,2023-07,2023-07-31,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy,Remifentanil Plus Ketamine Versus Midazolam Plus Fentanyl for Dynamic Flexible Bronchoscopy: Randomized Double-blind Clinical Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,Beth Israel Deaconess Medical Center,,2.0,,Change in procedure means limited value for study question,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-17 00:11:29.349696,2024-10-17 00:11:29.349696,OTHER,,,,,,,2023,0.0
NCT03184571,,2017-05-30,,2023-10-06,2023-10-06,2017-06-09,2017-06-12,ACTUAL,,,,,2023-10-10,ACTUAL,2023-10-06,2023-10-10,ACTUAL,2017-10-17,ACTUAL,2017-10-17,2023-10,2023-10-31,2022-10-27,ACTUAL,2022-10-27,2022-10-27,ACTUAL,2022-10-27,,INTERVENTIONAL,,,Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced NSCLC,A Phase II Multi Center Study of BGB324 in Combination With Pembrolizumab in Patients With Previously Treated Advanced Adenocarcinoma of the Lung,COMPLETED,,PHASE2,106.0,ACTUAL,BerGenBio ASA,,1.0,,,f,,,,t,t,f,,,,,,Beginning 3 months and ending 5 years following article publication,"Proposal should be directed to HYPERLINK mailto:clinical@bergenbio.com clinical@bergenbio.com. To gain access, data requestors will need to sign a data access agreement.",,YES,"Individual participant data that underlie the results reported in the article, after deidentification \[text, tables, figures and appendices\].",2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,INDUSTRY,,,,,,,2022,1.0
NCT04825860,,2021-03-29,,,2024-03-13,2021-03-29,2021-04-01,ACTUAL,,,,,,,2024-03-13,2024-03-15,ACTUAL,2021-03-29,ACTUAL,2021-03-29,2024-03,2024-03-31,2023-10-19,ACTUAL,2023-10-19,2023-10-12,ACTUAL,2023-10-12,,INTERVENTIONAL,,,"A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase","A Randomized, Double-blind, Parallel-group, Placebo Controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP 363856 in Acutely Psychotic Patients With Schizophrenia, Followed by an Open-label Extension Phase",TERMINATED,,PHASE2/PHASE3,83.0,ACTUAL,"Sumitomo Pharma Co., Ltd.",,3.0,,Due to company business strategy,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,INDUSTRY,,,,,,,2023,0.0
NCT02663271,,2016-01-21,2022-04-25,,2022-05-31,2016-01-21,2016-01-26,ESTIMATED,2022-05-31,2022-06-23,ACTUAL,,,,2022-05-31,2022-06-23,ACTUAL,2016-12-19,ACTUAL,2016-12-19,2022-05,2022-05-31,2021-06-11,ACTUAL,2021-06-11,2021-06-11,ACTUAL,2021-06-11,,INTERVENTIONAL,,,TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma,"A Phase 2, Multi-center, Single Arm, Histologically Controlled Study Testing the Combination of TTFields and Pulsed Bevacizumab Treatment in Patients With Bevacizumab-refractory Recurrent Glioblastoma",TERMINATED,,PHASE2,10.0,ACTUAL,University of Florida,,1.0,,stagnant enrollment,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,OTHER,,,,,,,2021,0.0
NCT03292731,,2017-09-20,2022-08-26,,2023-10-16,2017-09-20,2017-09-26,ACTUAL,2023-10-16,2023-10-23,ACTUAL,,,,2023-10-16,2023-10-23,ACTUAL,2018-02-12,ACTUAL,2018-02-12,2023-10,2023-10-31,2021-09-02,ACTUAL,2021-09-02,2021-09-02,ACTUAL,2021-09-02,,INTERVENTIONAL,PRO,Includes those who were compliant with study procedures and continued treatment,Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth,Relationship Between Plasma Concentration of (Hydroxyprogesterone Caproate) 17-OHPC and Preterm Birth,TERMINATED,,PHASE1/PHASE2,159.0,ACTUAL,University of Pittsburgh,Statistical analysis limited due to inadequate enrollment and subsequent small sample size and few cases of sPTB.,3.0,,grant funding cycle ended,f,,,,t,t,f,,,t,,,These data will be eligible to the recruiting centers after the main data are published. they will have 18 months to request secondary analyses . other researchers will have access to the data after that period.,To be determined by the OPRC steering committee.,,YES,"Deidentified data to be shared include plasma 17-OHPC concentrations , rates of sPTB, and data on maternal adverse effects and neonatal outcomes",2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,OTHER,,,,,,,2021,0.0
NCT04293172,,2020-02-04,,,2020-07-13,2020-02-28,2020-03-03,ACTUAL,,,,,,,2020-07-13,2020-07-15,ACTUAL,2020-06-30,ESTIMATED,2020-06-30,2020-07,2020-07-31,2022-10-10,ESTIMATED,2022-10-10,2022-10-10,ESTIMATED,2022-10-10,,INTERVENTIONAL,HESTIA5,,Study to Evaluate the Effect of Ticagrelor Versus Placebo in Reducing Vaso-Occlusive Crises Rate in Pediatric Patients With Sickle Cell Disease.,"A Randomised, Double Blind, Parallel Group, Multicentre, Phase III Study to Evaluate the Effect of Ticagrelor Versus Placebo in Reducing the Number of Vaso-Occlusive Crises in Paediatric Patients Aged 6 Months to <18 Years With Sickle Cell Disease (HESTIA5)",WITHDRAWN,,PHASE3,0.0,ACTUAL,AstraZeneca,,2.0,,"Study halted prematurely, prior to enrolment of first patient.",f,,,,t,t,f,,,,,,,,,,,2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,INDUSTRY,,,,,,,2022,0.0
NCT03743025,,2018-11-14,2024-05-02,,2024-05-02,2018-11-14,2018-11-15,ACTUAL,2024-05-02,2024-05-30,ACTUAL,,,,2024-05-02,2024-05-30,ACTUAL,2019-03-08,ACTUAL,2019-03-08,2024-05,2024-05-31,2023-05-02,ACTUAL,2023-05-02,2023-05-02,ACTUAL,2023-05-02,,INTERVENTIONAL,,,Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients,Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients,TERMINATED,,PHASE4,28.0,ACTUAL,Emory University,,2.0,,The study was terminated following the Data and Safety Monitoring Board (DSMB) review due to concerns with perioperative use of the study drug.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,OTHER,,,,,,,2023,0.0
NCT02401035,,2014-12-15,2024-03-11,,2024-03-11,2015-03-23,2015-03-27,ESTIMATED,2024-03-11,2024-04-09,ACTUAL,,,,2024-03-11,2024-04-09,ACTUAL,2017-05-09,ACTUAL,2017-05-09,2024-03,2024-03-31,2021-06-18,ACTUAL,2021-06-18,2021-06-18,ACTUAL,2021-06-18,,INTERVENTIONAL,,All enrolled participants were included in analysis.,"PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects","AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE PHARMACOKINETICS OF SINGLE AND MULTIPLE INTRAVENOUS DOSES OF PANTOPRAZOLE IN TWO AGE COHORTS OF HOSPITALIZED PEDIATRIC SUBJECTS 1 TO 16 YEARS OF AGE WHO ARE CANDIDATES FOR ACID SUPPRESSION THERAPY",TERMINATED,,PHASE4,19.0,ACTUAL,Pfizer,,1.0,,Study was terminated early due to the infeasibility of enrolling the required number of participants per protocol in the 1 \<2 years of age cohort.,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,INDUSTRY,,,,,,,2021,0.0
NCT03654976,,2018-08-24,2023-05-26,,2023-10-17,2018-08-30,2018-08-31,ACTUAL,2023-10-17,2023-10-19,ACTUAL,,,,2023-10-17,2023-10-19,ACTUAL,2018-02-22,ACTUAL,2018-02-22,2023-10,2023-10-31,2022-05-31,ACTUAL,2022-05-31,2022-05-18,ACTUAL,2022-05-18,,INTERVENTIONAL,MAPIT,All randomized participants,Mite Asthma Pediatric Immunotherapy Trial,A Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) Sublingual Immunotherapy (SLIT)-Tablet in Children and Adolescents (5-17 Years) With HDM Allergic Asthma,COMPLETED,,PHASE3,533.0,ACTUAL,ALK-Abelló A/S,Enrollment was paused at the outbreak of the COVID-19 pandemic. During the COVID-19 pandemic the asthma exacerbation rate decreased both in the trial population (blinded data) and in the general asthma population. It was therefore deemed difficult to recruit participants based on a history of recent asthma exacerbations. The sponsor decided to end the trial with the completed participants on 10-Aug-2022 due to the severe impact of COVID-19.,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,INDUSTRY,,,,,,,2022,1.0
NCT03158610,,2017-05-15,,,2021-04-28,2017-05-17,2017-05-18,ACTUAL,,,,,,,2021-04-28,2021-05-03,ACTUAL,2018-01-29,ACTUAL,2018-01-29,2021-04,2021-04-30,2021-04-28,ACTUAL,2021-04-28,2021-04-28,ACTUAL,2021-04-28,,INTERVENTIONAL,,,Biological-guided Metronomic Chemotherapy as Maintenance Strategy in Metastatic Colorectal Cancer,Biological-guided Metronomic Chemotherapy as Maintenance Strategy in Responders After Induction Therapy in Metastatic Colorectal Cancer,TERMINATED,,PHASE2/PHASE3,20.0,ACTUAL,Ruijin Hospital,,2.0,,Difficult to enrollment patient,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,OTHER,,,,,,,2021,0.0
NCT02293837,,2014-11-13,2021-07-22,2020-01-22,2021-08-16,2014-11-17,2014-11-18,ESTIMATED,2021-07-22,2021-08-17,ACTUAL,2020-01-22,2020-02-05,ACTUAL,2021-08-16,2021-09-08,ACTUAL,2015-03-12,ACTUAL,2015-03-12,2021-08,2021-08-31,2020-08-31,ACTUAL,2020-08-31,2019-07-10,ACTUAL,2019-07-10,,INTERVENTIONAL,EXTEND,"Randomized participants in each cohort were randomized 2:1 to tocilizumab or placebo, respectively.",Tocilizumab (TCZ) in New-onset Type 1 Diabetes,Preserving Beta-Cell Function With Tocilizumab in New-onset Type 1 Diabetes (ITN058AI),COMPLETED,,PHASE2,136.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,t,,,,,,,,"On average, within 24 months after database lock for the trial.",Open access.,https://www.immport.org/home,YES,"The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.",2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,NIH,,,,,,,2020,1.0
NCT05149807,,2021-11-09,,,2024-08-20,2021-11-24,2021-12-08,ACTUAL,,,,,,,2024-08-20,2024-08-22,ACTUAL,2022-01-26,ACTUAL,2022-01-26,2024-07,2024-07-31,2024-04-03,ACTUAL,2024-04-03,2024-04-03,ACTUAL,2024-04-03,,INTERVENTIONAL,,,Clinical Study of SHR-1701 Plus Chemotherapy as Perioperative Treatment in Subjects With Gastric Cancer,"A Randomized, Double-Blind, Multi-Center Phase II/III Clinical Study of PD-L1 Antibody/TGF-βRII (SHR-1701) Plus Tegafur Gimeracil Oteracil Potassium and Oxaliplatin Versus Placebo Plus Tegafur Gimeracil Oteracil Potassium and Oxaliplatin as Perioperative Treatment in Subjects With Resectable Gastric Cancer or Gastroesophageal Junction Cancer",TERMINATED,,PHASE2/PHASE3,81.0,ACTUAL,"Suzhou Suncadia Biopharmaceuticals Co., Ltd.",,2.0,,R\&d strategy adjustment,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,INDUSTRY,,,,,,,2024,0.0
NCT05137002,,2021-11-16,2023-07-05,,2023-07-28,2021-11-16,2021-11-30,ACTUAL,2023-07-28,2023-08-01,ACTUAL,,,,2023-07-28,2023-08-01,ACTUAL,2021-12-07,ACTUAL,2021-12-07,2023-07,2023-07-31,2022-10-10,ACTUAL,2022-10-10,2022-09-13,ACTUAL,2022-09-13,,INTERVENTIONAL,HALO,,A Study of CIN-107 in Patients With Uncontrolled Hypertension,"A Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 8 Weeks of Treatment in Patients With Uncontrolled Hypertension",COMPLETED,,PHASE2,249.0,ACTUAL,"CinCor Pharma, Inc.",,4.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,INDUSTRY,,,,,,,2022,0.0
NCT04836559,,2021-03-24,,,2024-03-11,2021-04-07,2021-04-08,ACTUAL,,,,,,,2024-03-11,2024-03-12,ACTUAL,2021-05-18,ACTUAL,2021-05-18,2024-03,2024-03-31,2024-02-08,ACTUAL,2024-02-08,2024-02-08,ACTUAL,2024-02-08,,INTERVENTIONAL,,,A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy,"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-40411813 as Adjunctive Therapy in Subjects With Focal Onset Seizures With Suboptimal Response to Levetiracetam or Brivaracetam",COMPLETED,,PHASE2,110.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,INDUSTRY,,,,,,,2024,0.0
NCT04930770,,2021-06-03,,,2023-02-17,2021-06-17,2021-06-18,ACTUAL,,,,,,,2023-02-17,2023-02-21,ACTUAL,2021-08-01,ESTIMATED,2021-08-01,2023-02,2023-02-28,2022-03-01,ESTIMATED,2022-03-01,2021-12-01,ESTIMATED,2021-12-01,,INTERVENTIONAL,VAX-TRES,,Study About the Response to the Administration of a Third Dose of mRNA-1273 Vaccine (COVID-19 Vaccine Moderna) in Renal Transplants With Immunological Failure Initial to Vaccination,Study About the Response to the Administration of a Third Dose of mRNA-1273 Vaccine (COVID-19 Vaccine Moderna) in Renal Transplants With Immunological Failure Initial to Vaccination,WITHDRAWN,,PHASE2,0.0,ACTUAL,Fundacion Clinic per a la Recerca Biomédica,,1.0,,No candidates for the trial (all patients have received the third dose of the vaccine),f,,,,t,f,f,,,,,,,,,,,2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,OTHER,,,,,,,2022,0.0
NCT02683239,,2016-01-28,2023-07-14,2021-11-30,2023-10-11,2016-02-16,2016-02-17,ESTIMATED,2023-10-11,2023-10-13,ACTUAL,2021-11-30,2021-12-06,ACTUAL,2023-10-11,2023-10-13,ACTUAL,2016-02-17,ACTUAL,2016-02-17,2023-10,2023-10-31,2021-06-15,ACTUAL,2021-06-15,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,FACT LTS & OA,The full analysis set for the evaluation of long-term safety (FAS-LTS) included all randomized participants in the study.,Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip,"A Phase 3 Randomized, Double-blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Long-Term Safety and the Efficacy of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip",COMPLETED,,PHASE3,5331.0,ACTUAL,Regeneron Pharmaceuticals,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,INDUSTRY,,,,,,,2021,1.0
NCT02888067,,2016-08-12,,,2023-10-19,2016-08-29,2016-09-02,ESTIMATED,,,,,,,2023-10-19,2023-10-23,ACTUAL,2017-07-01,ACTUAL,2017-07-01,2023-10,2023-10-31,2022-07-20,ACTUAL,2022-07-20,2022-07-20,ACTUAL,2022-07-20,,INTERVENTIONAL,,,Surgical Conditions During Vocal Cord Surgery Requiring Jet Ventilation With Moderate vs. Deep Neuromuscular Block,Surgical Conditions During Vocal Cord Surgery Requiring Jet Ventilation in Patients With Moderate vs. Deep Neuromuscular Block,TERMINATED,,PHASE1,12.0,ACTUAL,McGill University Health Centre/Research Institute of the McGill University Health Centre,,2.0,,Slow recruitment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,OTHER,,,,,,,2022,0.0
NCT04013880,,2019-07-05,,,2020-07-01,2019-07-05,2019-07-10,ACTUAL,,,,,,,2020-07-01,2020-07-07,ACTUAL,2019-08-27,ACTUAL,2019-08-27,2020-07,2020-07-31,2022-03-31,ESTIMATED,2022-03-31,2021-03-31,ESTIMATED,2021-03-31,,INTERVENTIONAL,,,ASTX727 and FT-2102 in Treating IDH1-Mutated Recurrent/Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia,"A Phase IB/II Study to Evaluate the Safety, Tolerability, and Efficacy of ASTX727 and FT-2102 in IDH1-Mutated Myelodysplastic Syndrome or Acute Myeloid Leukemia",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Vanderbilt-Ingram Cancer Center,,1.0,,Loss of funding,f,,,,t,t,f,,,,,,,,,,,2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,OTHER,,,,,,,2022,0.0
NCT05284019,,2022-02-23,2024-02-06,,2024-05-01,2022-03-09,2022-03-17,ACTUAL,2024-05-01,2024-05-29,ACTUAL,,,,2024-05-01,2024-05-29,ACTUAL,2022-03-04,ACTUAL,2022-03-04,2024-05,2024-05-31,2023-04-14,ACTUAL,2023-04-14,2023-02-17,ACTUAL,2023-02-17,,INTERVENTIONAL,EVEC,All randomized participants.,Real World Effectiveness of Eptinezumab in Participants With Migraine,"An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States",TERMINATED,,PHASE4,32.0,ACTUAL,H. Lundbeck A/S,The study was terminated early due to enrolment challenges.,3.0,,The study was terminated due to enrolment challenges.,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 15:30:47.895828,2024-10-15 15:30:47.895828,INDUSTRY,,,,,,,2023,0.0
NCT04304508,,2020-03-08,2023-02-15,,2023-04-17,2020-03-08,2020-03-11,ACTUAL,2023-04-17,2023-04-19,ACTUAL,,,,2023-04-17,2023-04-19,ACTUAL,2020-06-15,ACTUAL,2020-06-15,2023-04,2023-04-30,2022-02-18,ACTUAL,2022-02-18,2022-02-18,ACTUAL,2022-02-18,,INTERVENTIONAL,PACIFIC-STROKE,Full analysis set (FAS),Study to Gather Information About Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following a Recent Non Cardioembolic Ischemic Stroke Which Occurs When a Blood Clot Has Formed Somewhere in the Human Body (But Not in the Heart) Travelled to the Brain.,"Multicenter, Randomized, Placebo-controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate Efficacy and Safety of BAY2433334 in Patients Following an Acute Non-cardioembolic Ischemic Stroke",COMPLETED,,PHASE2,1808.0,ACTUAL,Bayer,,4.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,"Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,INDUSTRY,,,,,,,2022,1.0
NCT02047539,,2014-01-24,,,2021-05-13,2014-01-27,2014-01-28,ESTIMATED,,,,,,,2021-05-13,2021-05-17,ACTUAL,2015-01,,2015-01-31,2021-05,2021-05-31,2021-03,ACTUAL,2021-03-31,2021-03,ACTUAL,2021-03-31,,INTERVENTIONAL,,,Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Pre-psychosis,Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Patients With the Clinical Risk Syndrome for Psychosis,TERMINATED,,EARLY_PHASE1,1.0,ACTUAL,Yale University,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,OTHER,,,,,,,2021,0.0
NCT04808570,,2021-03-11,,,2023-11-24,2021-03-19,2021-03-22,ACTUAL,,,,,,,2023-11-24,2023-11-29,ACTUAL,2021-06-05,ACTUAL,2021-06-05,2023-10,2023-10-31,2023-11-22,ACTUAL,2023-11-22,2023-11-22,ACTUAL,2023-11-22,,INTERVENTIONAL,,,A Study of TQ-B3525 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma,"A Single-arm, Open-label, Multi-center Phase Ib/II Study of TQ-B3525 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma(CLL/SLL)",TERMINATED,,PHASE1/PHASE2,23.0,ACTUAL,"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",,1.0,,The sponsor terminated the study due to the R\&D strategy change.,f,,,,,f,f,,,,,,,,,,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,INDUSTRY,,,,,,,2023,0.0
NCT04040075,,2019-07-11,,,2023-01-03,2019-07-30,2019-07-31,ACTUAL,,,,,,,2023-01-03,2023-01-05,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2023-01,2023-01-31,2022-07-08,ACTUAL,2022-07-08,2022-06-14,ACTUAL,2022-06-14,,INTERVENTIONAL,,,Testing the Safety and Efficacy of Commercial Drug Biktarvy in Subjects Known to Have the 184 Resistance Mutation to a Component in Biktarvy,"Open-label Switch Study From a Regimen of Elvitegravir/Tenofovir Alafenamide/Emtricitabine/Cobicistat and Darunavir, to a FDC of Bictegravir/Tenofovir Alafenamide/Emtricitabine in Virologically Suppressed HIV-l Subjects Known to Have an 184 V/I Mutation",TERMINATED,,PHASE4,12.0,ACTUAL,"Southampton Healthcare, Inc.",,1.0,,"Unable to complete enrollment goals due to unanticipated factors of screen failures, covid pandemic, and continued staffing and enrollment difficulties",f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,OTHER,,,,,,,2022,0.0
NCT04305275,,2020-03-10,2024-01-30,2022-01-31,2024-03-20,2020-03-10,2020-03-12,ACTUAL,2024-03-20,2024-04-17,ACTUAL,,2024-04-17,ACTUAL,2024-03-20,2024-04-17,ACTUAL,2020-05-19,ACTUAL,2020-05-19,2024-03,2024-03-31,2021-02-15,ACTUAL,2021-02-15,2021-02-01,ACTUAL,2021-02-01,,INTERVENTIONAL,,Safety Set included all participants who were administered SAGE-324 or placebo.,"A Study to Evaluate the Efficacy, Safety, and Tolerability of SAGE-324 in Participants With Essential Tremor","A Phase 2, Double-Blind, Placebo-controlled, Randomized Study Evaluating the Efficacy, Safety, and Tolerability of Sage-324 in the Treatment of Individuals With Essential Tremor",COMPLETED,,PHASE2,69.0,ACTUAL,Sage Therapeutics,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,INDUSTRY,,,,,,,2021,1.0
NCT04406272,,2020-05-15,,,2024-08-22,2020-05-22,2020-05-28,ACTUAL,,,,,,,2024-08-22,2024-08-23,ACTUAL,2020-08-01,ACTUAL,2020-08-01,2024-08,2024-08-31,2024-08-01,ACTUAL,2024-08-01,2024-08-01,ACTUAL,2024-08-01,,INTERVENTIONAL,,,VB-111 in Surgically Accessible Recurrent/Progressive GBM,"A Randomized, Controlled Phase II Surgical Trial to Evaluate Early Immunologic Pharmacodynamic Parameters for the Viral Cancer Therapy Ofranergene Obadenovec (VB-111) in Patients With Surgically Accessible Recurrent/Progressive Glioblastoma",TERMINATED,,PHASE2,15.0,ACTUAL,Dana-Farber Cancer Institute,,3.0,,"Trial stopped at request of VBL Therapeutics, as they are no longer pursuing their VB-111 development program.",,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,OTHER,,,,,,,2024,0.0
NCT03364309,,2017-11-09,2021-06-03,,2021-06-03,2017-11-30,2017-12-06,ACTUAL,2021-06-03,2021-06-25,ACTUAL,,,,2021-06-03,2021-06-25,ACTUAL,2018-04-26,ACTUAL,2018-04-26,2021-06-01,2021-06-01,2020-06-04,ACTUAL,2020-06-04,2020-06-04,ACTUAL,2020-06-04,,INTERVENTIONAL,,All randomized participants.,A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis,"A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period to Evaluate the Efficacy and Safety of LY2439821 in Chinese Patients With Moderate-to-Severe Plaque Psoriasis",COMPLETED,,PHASE3,438.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,t,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,INDUSTRY,,,,,,,2020,1.0
NCT02019875,,2013-12-18,2023-01-17,,2023-03-27,2013-12-18,2013-12-24,ESTIMATED,2023-03-27,2023-04-19,ACTUAL,,,,2023-03-27,2023-04-19,ACTUAL,2014-06,,2014-06-30,2023-03,2023-03-31,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,,,CYP3A4 Activity and Mineral Homeostasis,Effect of Modulating CYP3A4 Activity on Mineral Homeostasis,COMPLETED,,EARLY_PHASE1,92.0,ACTUAL,University of Washington,None noted,6.0,,,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,OTHER,,,,,,,2020,1.0
NCT02663622,,2016-01-21,2021-05-24,,2024-01-19,2016-01-21,2016-01-26,ESTIMATED,2021-05-24,2021-06-18,ACTUAL,,,,2024-01-19,2024-01-23,ACTUAL,2016-09-19,ACTUAL,2016-09-19,2024-01,2024-01-31,2021-05-18,ACTUAL,2021-05-18,2020-06-08,ACTUAL,2020-06-08,,INTERVENTIONAL,,,"Phase II Trial of Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft-Versus-Host Disease (GVHD) Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-002)",A Phase II Trial of CD24Fc for Prevention of Acute Graft-versus-Host Disease Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplant,COMPLETED,,PHASE2,44.0,ACTUAL,"Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)",,4.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,INDUSTRY,,,,,,,2021,1.0
NCT01877187,,2013-03-27,2020-02-24,,2020-04-02,2013-06-10,2013-06-13,ESTIMATED,2020-04-02,2020-04-15,ACTUAL,,,,2020-04-02,2020-04-15,ACTUAL,2013-04,ACTUAL,2013-04-30,2020-04,2020-04-30,2020-02,ACTUAL,2020-02-29,2020-02,ACTUAL,2020-02-29,,INTERVENTIONAL,,,Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer,Lipiodol as an Imaging Biomarker of Tumor Necrosis After Transcatheter Chemoembolization Therapy in Patients With Primary and Metastatic Liver Cancer,COMPLETED,,PHASE2,39.0,ACTUAL,Yale University,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,OTHER,,,,,,,2020,1.0
NCT04771273,,2021-02-24,,,2024-04-29,2021-02-24,2021-02-25,ACTUAL,,,,,,,2024-04-29,2024-04-30,ACTUAL,2021-04-27,ACTUAL,2021-04-27,2024-04,2024-04-30,2023-12-21,ACTUAL,2023-12-21,2023-11-09,ACTUAL,2023-11-09,,INTERVENTIONAL,,,A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3),"Multicenter, Double-blind, Parallel-group, Randomized, 48 Weeks, Dose-ranging, Placebo-controlled Phase II Trial to Evaluate Efficacy, Safety and Tolerability of Multiple Subcutaneous (s.c.) Doses of BI 456906 in Patients With Non-alcoholic Steatohepatitis (NASH) and Fibrosis.",COMPLETED,,PHASE2,295.0,ACTUAL,Boehringer Ingelheim,,4.0,,,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,INDUSTRY,,,,,,,2023,1.0
NCT03906565,,2019-04-05,,,2023-01-08,2019-04-05,2019-04-08,ACTUAL,,,,,,,2023-01-08,2023-01-10,ACTUAL,2019-04-12,ACTUAL,2019-04-12,2023-01,2023-01-31,2024-12-31,ESTIMATED,2024-12-31,2023-12-31,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Colorectal Cancer,"Open, Multicenter, Monotherapy, Phase II Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Colorectal Cancer After Failure or Intolerability to Second-line Standard Treatment",SUSPENDED,,PHASE2,30.0,ESTIMATED,"Beijing Biostar Pharmaceuticals Co., Ltd.",,1.0,,"The efficacy evaluation (based on current data) deviated too much from results of previous clinical trials. It's assumed that high dropout rate of subjects, mainly due to covid-19 epidemic in China in the past 3 years, is the main reason.",f,,,,,f,f,,,,,,,,,,,2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,INDUSTRY,,,,,,,2024,0.0
NCT04983979,,2021-07-09,,,2023-08-15,2021-07-21,2021-07-30,ACTUAL,,,,,,,2023-08-15,2023-08-16,ACTUAL,2022-06-17,ACTUAL,2022-06-17,2023-06,2023-06-30,2023-05-16,ACTUAL,2023-05-16,2023-03-16,ACTUAL,2023-03-16,,INTERVENTIONAL,ORTIZ,,The ORTIZ Study: Optimising RASi Therapy With SZC,"A Multi Site, Placebo Controlled, Double Blind Randomised Clinical Trial Evaluating the Effectiveness of Sodium Zirconium Cyclosilicate Versus Placebo to Enable Safe Optimisation of RASi Therapy in Patients With Diabetic Kidney Disease.",TERMINATED,,PHASE2,10.0,ACTUAL,Barts & The London NHS Trust,,2.0,,Lack of recruitment,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,OTHER,,,,,,,2023,0.0
NCT04880785,,2021-04-29,,,2024-06-20,2021-05-05,2021-05-11,ACTUAL,,,,,,,2024-06-20,2024-06-24,ACTUAL,2021-07-28,ACTUAL,2021-07-28,2023-07,2023-07-31,2024-04-09,ACTUAL,2024-04-09,2023-06-12,ACTUAL,2023-06-12,,INTERVENTIONAL,VOLVER,,Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudine,Virologic Outcomes of Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudine.,COMPLETED,,PHASE2,121.0,ACTUAL,Fundacion SEIMC-GESIDA,,1.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,OTHER,,,,,,,2024,1.0
NCT04676724,,2020-12-15,2024-02-14,,2024-04-08,2020-12-15,2020-12-21,ACTUAL,2024-04-08,2024-05-02,ACTUAL,,,,2024-04-08,2024-05-02,ACTUAL,2021-01-28,ACTUAL,2021-01-28,2024-04,2024-04-30,2023-02-17,ACTUAL,2023-02-17,2023-02-17,ACTUAL,2023-02-17,,INTERVENTIONAL,B-Together,,Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB),"A Phase IIb Multi-Center, Randomised, Open Label Study to Assess the Efficacy and Safety of Sequential Treatment With GSK3228836 Followed by Pegylated Interferon Alpha 2a in Participants With Chronic Hepatitis B Virus (B-Together)",COMPLETED,,PHASE2,108.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,INDUSTRY,,,,,,,2023,1.0
NCT03381859,,2017-12-18,,,2020-04-16,2017-12-18,2017-12-22,ACTUAL,,,,,,,2020-04-16,2020-04-20,ACTUAL,2019-12-01,ESTIMATED,2019-12-01,2020-04,2020-04-30,2020-06-01,ESTIMATED,2020-06-01,2020-06-01,ESTIMATED,2020-06-01,,INTERVENTIONAL,CLEAR-C4,,"Clinical Trial to eLiminate HCV-infection in Treatment-naïve, Renally Impaired EgyptiAn Patients on Renal Dialysis, With Chronic Hepatitis C Genotype 4","A Single-site, Open-label, Non-comparator Clinical Trial to eLiminate HCV-infection in Treatment-naïve, EgyptiAn Patients With End-stage Renal Disease on Renal Dialysis, With Chronic Hepatitis C Genotype 4 Infection Using a 12-week Course of Once-daily Single Oral Tablet of Elbasvir (50mg)/Grazoprevir (100 mg)",WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of Maryland, Baltimore",,1.0,,HCV treatment expansion occurred in Egypt,f,,,,,t,f,,,t,,,,,,NO,,2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,OTHER,,,,,,,2020,0.0
NCT04077749,,2019-08-28,,,2021-07-02,2019-09-03,2019-09-04,ACTUAL,,,,,,,2021-07-02,2021-07-08,ACTUAL,2021-04-01,ESTIMATED,2021-04-01,2021-07,2021-07-31,2021-09-15,ESTIMATED,2021-09-15,2021-06-30,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients,A Randomized Double Blinded Study of Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Lahey Clinic,,2.0,,The study never started. It was withdrawn from the IRB.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,OTHER,,,,,,,2021,0.0
NCT05289570,,2022-03-11,2024-06-28,,2024-06-28,2022-03-11,2022-03-21,ACTUAL,2024-06-28,2024-07-24,ACTUAL,,,,2024-06-28,2024-07-24,ACTUAL,2022-05-03,ACTUAL,2022-05-03,2024-06,2024-06-30,2023-07-04,ACTUAL,2023-07-04,2023-06-28,ACTUAL,2023-06-28,,INTERVENTIONAL,Voxelotor,,Voxelotor for Improving Oxygen Saturation in Adults,"A Phase 2b Open-Label, Single Arm Study to Evaluate the Efficacy of Voxelotor for Improving Oxygen Saturation and Reducing Ventilatory Support Requirements in Adult Patients With New or Increased Oxygen Requirement",TERMINATED,,PHASE2,3.0,ACTUAL,Duke University,,1.0,,Terminated by new sponsor due to funding issues.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,OTHER,,,,,,,2023,0.0
NCT05162027,,2021-10-29,2024-01-16,,2024-03-04,2021-12-16,2021-12-17,ACTUAL,2024-03-04,2024-04-02,ACTUAL,,,,2024-03-04,2024-04-02,ACTUAL,2022-05-26,ACTUAL,2022-05-26,2024-03,2024-03-31,2023-01-03,ACTUAL,2023-01-03,2023-01-03,ACTUAL,2023-01-03,,INTERVENTIONAL,TMD CARE,Enrollees who completed baseline period and randomization,Erenumab-aooe for Temporomandibular Disorders Management: TMD Cgrp Antibody RElief (TMD CARE),Erenumab as a Therapeutic Approach for the Management of Painful Chronic Temporomandibular Disorders (TMD),TERMINATED,,PHASE2,5.0,ACTUAL,"University of Maryland, Baltimore",Early termination due to low enrollment rate.,2.0,,Low enrollment rate,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,OTHER,,,,,,,2023,0.0
NCT04492722,,2020-07-28,2023-09-05,,2023-12-07,2020-07-28,2020-07-30,ACTUAL,2023-12-07,2023-12-26,ACTUAL,,,,2023-12-07,2023-12-26,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2023-12,2023-12-31,2022-09-06,ACTUAL,2022-09-06,2022-09-06,ACTUAL,2022-09-06,,INTERVENTIONAL,,All participants who were randomised and received any study treatment were included in the Full Analysis Set (FAS).,A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease,"A Phase 2b Randomised, Double-Blind, Placebo-Controlled, Multi-Centre, Dose-Ranging Study of AZD5718 in Participants With Proteinuric Chronic Kidney Disease",TERMINATED,,PHASE2,613.0,ACTUAL,AstraZeneca,"Following study termination and reduced scope of the analysis, the PK analysis has not been performed.",4.0,,The Sponsor decided to terminate the study early due to lack of efficacy. There were no safety concerns related to the study.,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,INDUSTRY,,,,,,,2022,0.0
NCT04736628,,2021-02-01,2024-08-08,,2024-08-08,2021-02-01,2021-02-03,ACTUAL,2024-08-08,2024-09-04,ACTUAL,,,,2024-08-08,2024-09-04,ACTUAL,2021-04-27,ACTUAL,2021-04-27,2024-08,2024-08-31,2023-09-21,ACTUAL,2023-09-21,2023-08-15,ACTUAL,2023-08-15,,INTERVENTIONAL,,Randomised Set (RS): this patient set included all entered and randomised patients.,A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease,"Randomised, Double-blind (Within Dose Groups), Placebo Controlled and Parallel Group Trial to Investigate the Effects of Different Doses of Oral BI 685509 Given Over 20 Weeks on UACR Reduction in Patients With Non-diabetic Kidney Disease",COMPLETED,,PHASE2,261.0,ACTUAL,Boehringer Ingelheim,,4.0,,,f,,,,f,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,INDUSTRY,,,,,,,2023,1.0
NCT03699956,,2018-10-04,,,2024-03-22,2018-10-05,2018-10-09,ACTUAL,,,,,,,2024-03-22,2024-03-26,ACTUAL,2018-12-24,ACTUAL,2018-12-24,2024-03,2024-03-31,2024-03-01,ACTUAL,2024-03-01,2022-08-11,ACTUAL,2022-08-11,,INTERVENTIONAL,REPLATINUM,,RRx-001 Sequentially With a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond in Patients With Small Cell Lung Cancer,"A Phase 3, Controlled, Open-label, Randomized Study of RRx-001 Administered Sequentially With a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond Small Cell Lung Cancer",TERMINATED,,PHASE3,18.0,ACTUAL,"EpicentRx, Inc.",,2.0,,"RRx-001 will be studied under a new global, phase 3 clinical trial",,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,INDUSTRY,,,,,,,2024,0.0
NCT03789643,,2018-12-26,,,2019-05-01,2018-12-26,2018-12-28,ACTUAL,,,,,,,2019-05-01,2019-05-03,ACTUAL,2019-03,ESTIMATED,2019-03-31,2019-05,2019-05-31,2021-06,ESTIMATED,2021-06-30,2021-03,ESTIMATED,2021-03-31,,INTERVENTIONAL,RELIEF-PAH,,Study to Evaluate Efficacy and Safety of JTT-251 in Participants With Pulmonary Arterial Hypertension,"A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JTT-251 Administered for 24 Weeks to Participants With Pulmonary Arterial Hypertension (RELIEF-PAH)",WITHDRAWN,,PHASE2,0.0,ACTUAL,Akros Pharma Inc.,,4.0,,"Corporate decision, priority change",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,INDUSTRY,,,,,,,2021,0.0
NCT05307679,,2022-03-25,,,2024-07-01,2022-03-25,2022-04-01,ACTUAL,,,,,,,2024-07-01,2024-07-03,ACTUAL,2022-12-16,ACTUAL,2022-12-16,2024-07,2024-07-31,2024-03-04,ACTUAL,2024-03-04,2024-03-04,ACTUAL,2024-03-04,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Efficacy of Basmisanil Treatment in Children Aged 2-14 Years With Dup15q Syndrome,"A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety, Efficacy, and Pharmacodynamics of 52 Weeks of Treatment With Basmisanil in Participants Aged 2 to 14 Years Old With Dup15q Syndrome Followed by a 2-Year Optional Open-Label Extension",TERMINATED,,PHASE2,7.0,ACTUAL,Hoffmann-La Roche,,2.0,,The study was terminated due to sponsor decision and not related to safety or tolerability.,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,INDUSTRY,,,,,,,2024,0.0
NCT04142060,,2019-10-25,,,2022-10-25,2019-10-28,2019-10-29,ACTUAL,,,,,,,2022-10-25,2022-10-28,ACTUAL,2020-06-01,ACTUAL,2020-06-01,2022-06,2022-06-30,2022-10-10,ACTUAL,2022-10-10,2022-10-10,ACTUAL,2022-10-10,,INTERVENTIONAL,ARIANNA,,Targeting the PAM50 Her2-Enriched Phenotype With Enzalutamide in Hormone Receptor-Positive/Her2-Negative Metastatic BC,Targeting the PAM50 Her2-Enriched Phenotype With Enzalutamide in Hormone Receptor-Positive/Her2-Negative Metastatic Breast Cancer,TERMINATED,,PHASE2,34.0,ACTUAL,SOLTI Breast Cancer Research Group,,1.0,,Lack of effectiveness,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,OTHER,,,,,,,2022,0.0
NCT03491007,,2018-03-30,2022-06-30,,2023-05-03,2018-03-30,2018-04-06,ACTUAL,2023-05-03,2023-05-06,ACTUAL,,,,2023-05-03,2023-05-06,ACTUAL,2019-07-08,ACTUAL,2019-07-08,2023-05,2023-05-31,2020-11-16,ACTUAL,2020-11-16,2020-11-16,ACTUAL,2020-11-16,,INTERVENTIONAL,,,Neurosteroids in PTSD - Biomarkers to Therapeutics,Neurosteroids in PTSD - Biomarkers to Therapeutics,TERMINATED,,PHASE2,5.0,ACTUAL,VA Office of Research and Development,,2.0,,PI obtained outside employment that was not compatible with this award,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,FED,,,,,,,2020,0.0
NCT03731117,,2018-10-10,,,2020-12-11,2018-11-02,2018-11-06,ACTUAL,,,,,,,2020-12-11,2020-12-16,ACTUAL,2019-07-15,ACTUAL,2019-07-15,2020-12,2020-12-31,2020-12-07,ACTUAL,2020-12-07,2020-12-07,ACTUAL,2020-12-07,,INTERVENTIONAL,FURTHER,,FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU,FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU,TERMINATED,,PHASE4,11.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,1.0,,Study end date exceeded and insufficient number of subjects needed for analysis. 11 patients included / 70 theoretical patients,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,OTHER,,,,,,,2020,0.0
NCT03970694,,2019-05-26,,,2022-06-05,2019-05-30,2019-05-31,ACTUAL,,,,,,,2022-06-05,2022-06-08,ACTUAL,2019-05-11,ACTUAL,2019-05-11,2022-06,2022-06-30,2022-06-05,ACTUAL,2022-06-05,2022-05-30,ACTUAL,2022-05-30,,INTERVENTIONAL,,,Neoadjuvant Chemoradiotherapy Versus Neoadjuvant Chemotherapy For Unresectable Locally Advanced Colon Cancer,"Neoadjuvant Chemoradiotherapy Versus Neoadjuvant Chemotherapy For Unresectable Locally Advanced Colon Cancer: An Open, Multi-centered, Randomize Controlled Phase 3 Trial.",TERMINATED,,PHASE3,49.0,ACTUAL,Sun Yat-sen University,,2.0,,Significant differences in conversion rate as well as R0 resection rate between the two groups.,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,OTHER,,,,,,,2022,0.0
NCT04735796,,2021-01-28,,,2022-10-24,2021-02-02,2021-02-03,ACTUAL,,,,,,,2022-10-24,2022-10-26,ACTUAL,2021-05-27,ACTUAL,2021-05-27,2022-10,2022-10-31,2022-05-19,ACTUAL,2022-05-19,2022-05-19,ACTUAL,2022-05-19,,INTERVENTIONAL,,,Study of LM-102 in Subjects in Advanced Tumors,"A Phase I, First-in-Human, Open-Label, Dose Escalation Study of LM-102 Injection in Subjects With CLDN18.2-Positive Advanced Solid Tumors",TERMINATED,,PHASE1,9.0,ACTUAL,LaNova Medicines Limited,,5.0,,Business strategy changed,f,,,,f,t,f,,,,,,,,,,,2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,INDUSTRY,,,,,,,2022,0.0
NCT03540199,,2018-05-16,,,2020-10-13,2018-05-16,2018-05-30,ACTUAL,,,,,,,2020-10-13,2020-10-19,ACTUAL,2018-04-10,ACTUAL,2018-04-10,2020-05,2020-05-31,2020-09-10,ACTUAL,2020-09-10,2020-05-20,ACTUAL,2020-05-20,,INTERVENTIONAL,,,Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Kidney Cancer,Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Kidney Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Fuda Cancer Hospital, Guangzhou",,3.0,,No participant enrolled,f,,,,t,f,f,,,,,,,,,,,2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,OTHER,,,,,,,2020,0.0
NCT02768337,,2016-04-28,,,2024-01-30,2016-05-10,2016-05-11,ESTIMATED,,,,,,,2024-01-30,2024-01-31,ACTUAL,2015-03-10,ACTUAL,2015-03-10,2024-01,2024-01-31,2021-08-12,ACTUAL,2021-08-12,2020-08-12,ACTUAL,2020-08-12,,INTERVENTIONAL,CamBMT1,,Cambridge Brain Mets Trial 1,"Cambridge Brain Mets Trial 1: A Proof-of-principle Phase 1b/Randomised Phase 2 Study of Afatinib Penetration Into Cerebral Metastases for Patients Undergoing Neurosurgical Resection, Both With and Without Prior Low-dose, Targeted Radiotherapy",TERMINATED,,PHASE1/PHASE2,26.0,ACTUAL,Cambridge University Hospitals NHS Foundation Trust,,3.0,,Slow recruitment,f,,,,t,,,,,,,,,,,,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,OTHER,,,,,,,2021,0.0
NCT04728698,,2021-01-26,,,2021-09-14,2021-01-26,2021-01-28,ACTUAL,,,,,,,2021-09-14,2021-09-16,ACTUAL,2021-03,ESTIMATED,2021-03-31,2021-09,2021-09-30,2021-09,ESTIMATED,2021-09-30,2021-09,ESTIMATED,2021-09-30,,INTERVENTIONAL,,,Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress,Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,2.0,,Replaced by a different protocol.,f,,,,,t,f,,,f,,,,,,,,2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,INDUSTRY,,,,,,,2021,0.0
NCT03861936,,2019-02-25,2021-04-02,,2021-04-02,2019-03-01,2019-03-05,ACTUAL,2021-04-02,2021-04-28,ACTUAL,,,,2021-04-02,2021-04-28,ACTUAL,2019-05-16,ACTUAL,2019-05-16,2021-04,2021-04-30,2020-07-02,ACTUAL,2020-07-02,2020-04-03,ACTUAL,2020-04-03,,INTERVENTIONAL,,Modified Intent-to-treat (mITT) Population consisted of all randomized participants who received study treatment and had at least 1 postbaseline Masseter Muscle Prominence Scale (MMPS) assessment.,BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence,"BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 2b, Multicenter, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study",COMPLETED,,PHASE2,150.0,ACTUAL,Allergan,,3.0,,,f,,,,,t,f,,,,,,After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.,"To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.",http://www.allerganclinicaltrials.com/,YES,"Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.",2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,INDUSTRY,,,,,,,2020,1.0
NCT02992340,,2016-12-08,,,2021-01-12,2016-12-10,2016-12-14,ESTIMATED,,,,,,,2021-01-12,2021-01-14,ACTUAL,2016-12-13,ACTUAL,2016-12-13,2020-01,2020-01-31,2020-11-24,ACTUAL,2020-11-24,2020-06-16,ACTUAL,2020-06-16,,INTERVENTIONAL,,,Varlitinib in Combination With Gemcitabine and Cisplatin for Treatment naïve Advanced or Metastatic BTC,"A Multicentre, Phase 1B/2 Study of Varlitinib in Combination With Gemcitabine and Cisplatin for Treatment naïve Advanced or Metastatic Biliary Tract Cancer.",TERMINATED,,PHASE1/PHASE2,204.0,ESTIMATED,ASLAN Pharmaceuticals,,1.0,,Sponsor decided to terminate the study and not proceed to Phase 2.,f,,,,t,,,,,,,,,,,NO,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,OTHER,,,,,,,2020,0.0
NCT03066778,,2017-02-23,2020-11-25,,2022-09-02,2017-02-23,2017-02-28,ACTUAL,2020-11-25,2020-12-22,ACTUAL,,,,2022-09-02,2022-10-03,ACTUAL,2017-05-02,ACTUAL,2017-05-02,2022-08,2022-08-31,2021-09-21,ACTUAL,2021-09-21,2019-12-02,ACTUAL,2019-12-02,,INTERVENTIONAL,,All participants randomized by intention to treat (ITT).,A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604),"A Phase 3 Randomized, Double-Blind, Placebo-controlled Trial of Pembrolizumab (MK-3475/SCH900475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for the First-line Treatment of Subjects With Extensive Stage Small Cell Lung Cancer (KEYNOTE-604)",COMPLETED,,PHASE3,453.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,INDUSTRY,,,,,,,2021,1.0
NCT04166929,,2019-11-14,,,2023-10-02,2019-11-15,2019-11-18,ACTUAL,,,,,,,2023-10-02,2023-10-04,ACTUAL,2020-01-15,ACTUAL,2020-01-15,2021-05,2021-05-31,2023-09-28,ACTUAL,2023-09-28,2023-09-28,ACTUAL,2023-09-28,,INTERVENTIONAL,Bigeminy,,Haploidentical Stem Cell Transplant With or Without NK Cell Infusion in AML and MDS,Haploidentical Stem Cell Transplantation With or Without NK Cell Infusion in Refractory/Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndrome:The BigEMINy Study,TERMINATED,,PHASE2,6.0,ACTUAL,Fondazione Policlinico Universitario Agostino Gemelli IRCCS,,2.0,,low recruitment,f,,,,,f,f,,,,,,,,,,,2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,OTHER,,,,,,,2023,0.0
NCT03999840,,2019-06-25,,,2021-03-08,2019-06-25,2019-06-27,ACTUAL,,,,,,,2021-03-08,2021-03-10,ACTUAL,2021-01,ESTIMATED,2021-01-31,2021-03,2021-03-31,2024-03,ESTIMATED,2024-03-31,2024-01,ESTIMATED,2024-01-31,,INTERVENTIONAL,DANCE,,Eculizumab to Cemdisiran Switch in aHUS,"A Phase II, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Cemdisiran (ALN-CC5) Following Withdrawal of Chronic Eculizumab Therapy in Patients With Atypical HUS at High Risk of Recurrence",WITHDRAWN,,PHASE2,0.0,ACTUAL,Mario Negri Institute for Pharmacological Research,,2.0,,Due to the COVID global pandemic Sponsor has not received the economic support necessary for the study conduction.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,OTHER,,,,,,,2024,0.0
NCT03598816,,2018-07-16,,,2020-08-12,2018-07-16,2018-07-26,ACTUAL,,,,,,,2020-08-12,2020-08-13,ACTUAL,2020-08-31,ESTIMATED,2020-08-31,2020-08,2020-08-31,2024-05-31,ESTIMATED,2024-05-31,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,PIVOT-RCC,,PolyImmune {Durvalumab (MEDI4736) and Tremelimumab} & Vaccine Orchestrated Treatment for Patients With Advanced/Metastatic Renal Cell Carcinoma,A Randomized Phase II PIVOT-RCC (PolyImmune {Durvalumab (MEDI4736) and Tremelimumab} & Vaccine Orchestrated Treatment for Patients With Advanced/Metastatic Renal Cell Carcinoma) Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,Washington University School of Medicine,,2.0,,FDA Contingencies unresolved,f,,,,t,t,t,,,f,,,,,,NO,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,OTHER,,,,,,,2024,0.0
NCT03751124,,2018-11-13,2022-08-26,,2024-05-31,2018-11-20,2018-11-23,ACTUAL,2024-05-31,2024-06-25,ACTUAL,,,,2024-05-31,2024-06-25,ACTUAL,2018-10-16,ACTUAL,2018-10-16,2024-05,2024-05-31,2021-10-20,ACTUAL,2021-10-20,2021-02-19,ACTUAL,2021-02-19,,INTERVENTIONAL,,mITT population: all participants randomized to treatment who had taken at least one dose of study treatment (relugolix plus E2/NETA or placebo).,Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids,"An International Phase 3 Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids",COMPLETED,,PHASE3,229.0,ACTUAL,Myovant Sciences GmbH,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,INDUSTRY,,,,,,,2021,1.0
NCT02307513,,2014-12-02,2019-08-16,2018-01-10,2021-07-02,2014-12-02,2014-12-04,ESTIMATED,2019-08-16,2019-09-11,ACTUAL,2018-01-10,2018-01-16,ACTUAL,2021-07-02,2021-07-22,ACTUAL,2014-12-30,ACTUAL,2014-12-30,2021-07,2021-07-31,2020-07-17,ACTUAL,2020-07-17,2017-09-25,ACTUAL,2017-09-25,,INTERVENTIONAL,,The intent to treat (ITT) population was defined as all randomized participants who received at least 1 dose of investigational product (IP). Participants were included in the treatment group to which they were originally randomized.,"A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease","A Phase 3, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel Group Study, Followed by an Active-treatment Phase to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Subjects With Active Behcet's Disease",COMPLETED,,PHASE3,207.0,ACTUAL,Amgen,,2.0,,,t,,,,t,,,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,INDUSTRY,,NCT03740516,NO_LONGER_AVAILABLE,,,,2020,1.0
NCT04200365,,2019-12-10,,,2023-11-30,2019-12-13,2019-12-16,ACTUAL,,,,,,,2023-11-30,2023-12-04,ACTUAL,2020-06-05,ACTUAL,2020-06-05,2023-11,2023-11-30,2023-09-07,ACTUAL,2023-09-07,2023-09-07,ACTUAL,2023-09-07,,INTERVENTIONAL,,,A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD),A Pilot Study of INCB039110 (Itacitinib) for the Treatment of Steroid Refractory Chronic Graft-Versus-Host Disease,TERMINATED,,PHASE2,15.0,ACTUAL,"SCRI Development Innovations, LLC",,1.0,,Slow enrollment and PI departure,f,,,,f,t,f,,,,,,,,,,,2024-10-17 00:17:46.817709,2024-10-17 00:17:46.817709,OTHER,,,,,,,2023,0.0
NCT05418673,,2022-06-10,2024-02-27,,2024-05-31,2022-06-10,2022-06-14,ACTUAL,2024-05-31,2024-06-26,ACTUAL,,,,2024-05-31,2024-06-26,ACTUAL,2022-08-26,ACTUAL,2022-08-26,2024-05,2024-05-31,2023-07-27,ACTUAL,2023-07-27,2023-07-27,ACTUAL,2023-07-27,,INTERVENTIONAL,LIGHTHOUSE,"Full analysis set (FAS) included all randomized participants who had received at least 1 dose of study treatment. Since a low number of participants were enrolled in the study and some of the participants have been rolled over to the 283PD201 (NCT05348785), the data was reported as a pooled group to avoid the identification of individual participants and to maintain the blinding.",A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale,"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122/DNL151 in Participants With Parkinson's Disease and Pathogenic LRRK2 Variants",TERMINATED,,PHASE3,7.0,ACTUAL,Biogen,"Sponsor decided to stop study based on operational and strategic considerations and not for reasons related to efficacy/safety. Due to the early cessation of the study before participants reached the time window for efficacy assessments, efficacy analysis was not possible.",2.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,INDUSTRY,,,,,,,2023,0.0
NCT03513471,,2018-04-19,,,2021-05-05,2018-04-19,2018-05-01,ACTUAL,,,,,,,2021-05-05,2021-05-07,ACTUAL,2019-08-09,ACTUAL,2019-08-09,2021-05,2021-05-31,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,EarlyAna,,Early Phase Administration of Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation,Early Phase Administration of Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,The risk of inhaled allergen challenge and anakinra treatment outweigh benefits to participants with allergic asthma due to the COVID-19 pandemic.,f,,,,t,t,f,,,,,,,,,,,2024-10-17 00:23:53.073667,2024-10-17 00:23:53.073667,OTHER,,,,,,,2021,0.0
NCT04547140,,2020-09-10,2022-12-13,,2023-03-17,2020-09-10,2020-09-14,ACTUAL,2023-03-17,2023-03-22,ACTUAL,,,,2023-03-17,2023-03-22,ACTUAL,2021-01-29,ACTUAL,2021-01-29,2023-03,2023-03-31,2022-01-28,ACTUAL,2022-01-28,2021-12-13,ACTUAL,2021-12-13,,INTERVENTIONAL,,Intent-to-Treat (ITT) population included all participants who were randomized.,Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19),"A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) Plus Standard Medical Treatment (SMT) Versus Placebo Plus SMT in Hospitalized Subjects With COVID-19",TERMINATED,,PHASE2,57.0,ACTUAL,Grifols Therapeutics LLC,Study was early terminated due to lack of efficacy (futility).,2.0,,Study Stopped for Futility,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 00:23:53.073667,2024-10-17 00:23:53.073667,INDUSTRY,,,,,,,2022,0.0
NCT03959592,,2019-05-17,2022-10-15,,2022-12-08,2019-05-21,2019-05-22,ACTUAL,2022-12-08,2023-01-03,ACTUAL,,,,2022-12-08,2023-01-03,ACTUAL,2019-08-21,ACTUAL,2019-08-21,2022-12,2022-12-31,2021-11-09,ACTUAL,2021-11-09,2021-11-09,ACTUAL,2021-11-09,,INTERVENTIONAL,,,Macular Pigment and Visual Performance in Glaucoma Patients,Macular Pigment and Visual Performance in Glaucoma Patients,TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,Duke University,,2.0,,Preliminary analysis showed no benefit of the investigational supplement.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,OTHER,,,,,,,2021,0.0
NCT03810313,,2019-01-17,2022-07-12,,2023-01-27,2019-01-17,2019-01-18,ACTUAL,2022-07-12,2022-08-08,ACTUAL,,,,2023-01-27,2023-01-30,ACTUAL,2019-07-03,ACTUAL,2019-07-03,2023-01,2023-01-31,2021-07-26,ACTUAL,2021-07-26,2021-07-26,ACTUAL,2021-07-26,,INTERVENTIONAL,RAVEN,,Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion,"An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion",TERMINATED,,PHASE3,493.0,ACTUAL,Novartis,,2.0,,"Study was terminated by sponsor due to increased incidences of adverse events of special interest (intraocular inflammation including retinal vasculitis, and retinal vascular occlusion), in patients dosed every 4 weeks beyond 3 initial doses.",f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,INDUSTRY,,,,,,,2021,0.0
NCT05545683,,2022-09-06,,,2023-02-07,2022-09-15,2022-09-19,ACTUAL,,,,,,,2023-02-07,2023-02-09,ACTUAL,2022-12-01,ESTIMATED,2022-12-01,2023-02,2023-02-28,2024-06-30,ESTIMATED,2024-06-30,2023-03-30,ESTIMATED,2023-03-30,,INTERVENTIONAL,,,Safety and Immunogenicity of Inactivated Heterologous Booster Vaccination,"Open-Label Phase 3 Clinical Study to Investigate Safety and Immunogenicity of a Single VLA2001 Booster Vaccination in Volunteers Aged ≥18 Years, After Priming With Another Inactivated COVID-19 Vaccine",WITHDRAWN,,PHASE3,0.0,ACTUAL,Centro de Estudios en Infectogía Pediatrica,,1.0,,funding was suspended,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,OTHER,,,,,,,2024,0.0
NCT03621982,,2018-06-28,2023-12-08,,2024-06-12,2018-08-06,2018-08-09,ACTUAL,2024-06-12,2024-06-13,ACTUAL,,,,2024-06-12,2024-06-13,ACTUAL,2018-11-09,ACTUAL,2018-11-09,2024-06,2024-06-30,2022-12-14,ACTUAL,2022-12-14,2022-12-14,ACTUAL,2022-12-14,,INTERVENTIONAL,,,Study of ADCT-301 in Patients With Selected Advanced Solid Tumors,"A Phase 1b, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) as Monotherapy or in Combination in Patients With Selected Advanced Solid Tumors",TERMINATED,,PHASE1,78.0,ACTUAL,ADC Therapeutics S.A.,,2.0,,"Cami in combination with pembrolizumab in solid tumors showed signals of immunomodulatory activity. However, the signals were insufficiently compelling at the tested dose/schedule to justify continuation of the study.",f,,,,,t,f,,,,,,,,,NO,,2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,INDUSTRY,,,,,,,2022,0.0
NCT04116359,,2019-10-03,,,2020-09-25,2019-10-03,2019-10-04,ACTUAL,,,,,,,2020-09-25,2020-09-28,ACTUAL,2020-09-18,ACTUAL,2020-09-18,2020-09,2020-09-30,2020-09-18,ACTUAL,2020-09-18,2020-09-18,ACTUAL,2020-09-18,,INTERVENTIONAL,,,"Testing of the Addition of a New Anti-cancer Drug, Molibresib, to Chemotherapy Treatment (Etoposide and Cisplatin) for Patients With NUT Carcinoma",A Phase 1/2 Study of the Bromodomain Inhibitor Molibresib in Combination With Etoposide/Platinum in Patients With NUT Carcinoma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,National Cancer Institute (NCI),,2.0,,Other - Protocol moved to Disapproved,,,,,t,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.",2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,NIH,,,,,,,2020,0.0
NCT03548064,,2018-05-24,2021-12-16,,2023-08-03,2018-05-24,2018-06-06,ACTUAL,2021-12-16,2022-01-18,ACTUAL,,,,2023-08-03,2023-08-21,ACTUAL,2019-03-10,ACTUAL,2019-03-10,2017-12-14,2017-12-14,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,"A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area","A Phase 1 Double-Blinded, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Immunogenicity of Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) From Enterotoxigenic Escherichia Coli (ETEC) by Oral, Sublingual, or Intradermal Vaccination in Adults Residing in an Endemic Area",TERMINATED,,PHASE1,75.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,9.0,,COVID 19 cases at the site,f,,,,,t,f,,,f,,,,,,,,2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,NIH,,,,,,,2020,0.0
NCT02465437,,2015-06-04,2018-03-08,,2021-03-25,2015-06-04,2015-06-08,ESTIMATED,2018-10-01,2018-10-02,ACTUAL,,,,2021-03-25,2021-04-21,ACTUAL,2015-08,,2015-08-31,2021-03,2021-03-31,2020-12-11,ACTUAL,2020-12-11,2016-10,ACTUAL,2016-10-31,,INTERVENTIONAL,,,"Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis","A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Diffuse Cutaneous Systemic Sclerosis",TERMINATED,,PHASE2,42.0,ACTUAL,Corbus Pharmaceuticals Inc.,,5.0,,Sponsor terminated open-label extension,f,,,,f,,,,,,,,,,,,,2024-10-17 00:23:53.073667,2024-10-17 00:23:53.073667,INDUSTRY,,,,,,,2020,0.0
NCT04146935,,2019-10-29,2023-07-27,,2023-08-22,2019-10-29,2019-10-31,ACTUAL,2023-08-22,2023-08-24,ACTUAL,,,,2023-08-22,2023-08-24,ACTUAL,2019-11-13,ACTUAL,2019-11-13,2023-08,2023-08-31,2022-08-25,ACTUAL,2022-08-25,2022-08-25,ACTUAL,2022-08-25,,INTERVENTIONAL,,,Examining the Effect of Burosumab on Muscle Function,Examining the Effect of Burosumab on Muscle Function Using MR Spectroscopy,COMPLETED,,PHASE4,10.0,ACTUAL,Yale University,,1.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,OTHER,,,,,,,2022,1.0
NCT04633187,,2020-11-11,2024-07-15,,2024-08-20,2020-11-11,2020-11-18,ACTUAL,2024-08-20,2024-08-22,ACTUAL,,,,2024-08-20,2024-08-22,ACTUAL,2021-07-07,ACTUAL,2021-07-07,2024-07,2024-07-31,2023-05-31,ACTUAL,2023-05-31,2023-05-31,ACTUAL,2023-05-31,,INTERVENTIONAL,RSVTx,,Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract,"A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effects of EDP-938 in Hematopoietic Cell Transplant Recipients With Acute Respiratory Syncytial Virus Infection of the Upper Respiratory Tract",TERMINATED,,PHASE2,9.0,ACTUAL,"Enanta Pharmaceuticals, Inc",,2.0,,Study was terminated due to a strategic business decision and not due to safety concerns.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,INDUSTRY,,,,,,,2023,0.0
NCT04235322,,2020-01-16,,,2023-10-06,2020-01-17,2020-01-21,ACTUAL,,,,,,,2023-10-06,2023-10-10,ACTUAL,2021-01-25,ACTUAL,2021-01-25,2023-10,2023-10-31,2023-04-18,ACTUAL,2023-04-18,2023-04-18,ACTUAL,2023-04-18,,INTERVENTIONAL,HEARTH-GEN,,Study of 2LHERP® in Genital Herpes Infections,"Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of 2LHERP® in Patients With Recurrent Genital Herpes Infections",TERMINATED,,PHASE4,6.0,ACTUAL,Labo'Life,,2.0,,"Labo'life decided to end prematurely HEARTH-GEN study from April 18th 2023 due to very low recruitment rates (6/100). Labo'life decided to focus all its efforts on another study using 2LHERP® in herpes treatment, called HEARTH-OF (NCT04065971)",f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 00:23:53.073667,2024-10-17 00:23:53.073667,INDUSTRY,,,,,,,2023,0.0
NCT05005000,,2021-08-12,,,2024-01-10,2021-08-12,2021-08-13,ACTUAL,,,,,,,2024-01-10,2024-01-12,ACTUAL,2022-05-12,ACTUAL,2022-05-12,2024-01,2024-01-31,2023-05-25,ACTUAL,2023-05-25,2023-05-25,ACTUAL,2023-05-25,,INTERVENTIONAL,,,Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis,Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis,WITHDRAWN,,PHASE2,0.0,ACTUAL,NYU Langone Health,,2.0,,Difficulties getting subjects recruited and enrolled.,f,,,,f,t,f,,,t,,,Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.,"The investigator who proposed to use the data upon reasonable request. Requests should be directed to Jacques.Hacquebord@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.",,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) upon reasonable request.",2024-10-16 12:10:21.769278,2024-10-16 12:10:21.769278,OTHER,,,,,,,2023,0.0
NCT02554903,,2015-09-08,2021-03-08,,2021-03-08,2015-09-17,2015-09-18,ESTIMATED,2021-03-08,2021-04-01,ACTUAL,,,,2021-03-08,2021-04-01,ACTUAL,2016-03-28,ACTUAL,2016-03-28,2021-03,2021-03-31,2020-03-13,ACTUAL,2020-03-13,2020-03-13,ACTUAL,2020-03-13,,INTERVENTIONAL,SOPRANO,,Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation,"A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation",COMPLETED,,PHASE2,57.0,ACTUAL,Actelion,A limitation of this study was its slow enrollment and a final sample size that was less than the predefined target.,2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,INDUSTRY,,,,,,,2020,1.0
NCT03558984,,2018-06-05,,,2022-11-09,2018-06-14,2018-06-15,ACTUAL,,,,,,,2022-11-09,2022-11-15,ACTUAL,2019-12-17,ACTUAL,2019-12-17,2022-11,2022-11-30,2022-10-24,ACTUAL,2022-10-24,2022-10-24,ACTUAL,2022-10-24,,INTERVENTIONAL,,,D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery,"Prospective, Multicenter, Randomized, Parallel Controlled, Two Arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly With the SOC IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections",TERMINATED,,PHASE3,2.0,ACTUAL,PolyPid Ltd.,,2.0,,company prioritization reasons,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,INDUSTRY,,,,,,,2022,0.0
NCT04315246,,2020-03-12,,,2022-07-12,2020-03-16,2020-03-19,ACTUAL,,,,,,,2022-07-12,2022-07-15,ACTUAL,2022-08-31,ESTIMATED,2022-08-31,2022-07,2022-07-31,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,"177Lu-DTPA-Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors (Breast, NSCLC, Malignant Melanoma)",A Phase I/II Trial of Intracerebroventricular 177Lu DTPA Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Y-mAbs Therapeutics,,1.0,,Business priorities,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,INDUSTRY,,,,,,,2024,0.0
NCT03553615,,2018-05-30,,,2019-04-08,2018-05-30,2018-06-12,ACTUAL,,,,,,,2019-04-08,2019-04-10,ACTUAL,2018-12,ESTIMATED,2018-12-31,2019-04,2019-04-30,2020-12,ESTIMATED,2020-12-31,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,Open-label Pilot Clinical Trial of Oral Ivermectin to Treat Atopic Dermatitis,Open-label Pilot Clinical Trial of Oral Ivermectin to Treat Atopic Dermatitis,WITHDRAWN,,PHASE2,0.0,ACTUAL,Stanford University,,1.0,,Limited clinical capacity,f,,,,,t,f,,,f,,,,,,,,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,OTHER,,,,,,,2020,0.0
NCT03982134,,2019-06-06,,,2019-10-01,2019-06-06,2019-06-11,ACTUAL,,,,,,,2019-10-01,2019-10-04,ACTUAL,2019-09,ESTIMATED,2019-09-30,2019-10,2019-10-31,2022-05-01,ESTIMATED,2022-05-01,2021-05-01,ESTIMATED,2021-05-01,,INTERVENTIONAL,,,PDR001 + Panobinostat for Melanoma and NSCLC,Phase Ib Study to Assess Safety and Tolerability of PDR001 in Combination With Panobinostat in Metastatic Melanoma and Non-small Cell Lung Cancer After Failure of Prior Anti PD1 or PD-L1 Therapy,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Iowa,,1.0,,Sponsor decision to withdraw,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:45:56.682396,2024-10-15 06:45:56.682396,OTHER,,,,,,,2022,0.0
NCT04629651,,2020-11-10,,,2023-10-09,2020-11-10,2020-11-16,ACTUAL,,,,,,,2023-10-09,2023-10-11,ACTUAL,2024-04,ESTIMATED,2024-04-30,2023-10,2023-10-31,2024-10,ESTIMATED,2024-10-31,2024-10,ESTIMATED,2024-10-31,,INTERVENTIONAL,,,Captopril Use on the Degree of Marrow Fibrosis in Bone Marrow Fibrosis/Myeloproliferative Neoplasms,Phase I/II Prospective Trial Investigating the Safety and Efficacy of Captopril Use on the Degree of Marrow Fibrosis in Patients With Primary or Secondary Bone Marrow Fibrosis/Myeloproliferative Neoplasms,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Case Comprehensive Cancer Center,,1.0,,PI discretion,f,,,,t,t,f,,,t,,,,,,YES,There is a plan to make all individual participant data (IPD) and related data dictionaries available. We will also make the protocol available.,2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,OTHER,,,,,,,2024,0.0
NCT03990363,,2019-05-30,2022-10-28,,2023-02-01,2019-06-17,2019-06-19,ACTUAL,2023-02-01,2023-03-02,ACTUAL,,,,2023-02-01,2023-03-02,ACTUAL,2019-07-23,ACTUAL,2019-07-23,2023-01,2023-01-31,2021-11-22,ACTUAL,2021-11-22,2021-11-22,ACTUAL,2021-11-22,,INTERVENTIONAL,SAPPHIRE,,A Study of Verinurad and Allopurinol in Patients With Chronic Kidney Disease and Hyperuricaemia,"A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled Study of Verinurad and Allopurinol in Patients With Chronic KIdney Disease and Hyperuricaemia",COMPLETED,,PHASE2,861.0,ACTUAL,AstraZeneca,"The study was initially planned to be 108 weeks. However, following the implementation of the amendment in Protocol Version 5.0, all patients discontinued therapy after 60 weeks (Visit 10).~Subjects that were on Low dose at Visit 9 were switched to 24 mg dose.~The study was terminated in Mexico in March 2021.",5.0,,,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool.~Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.~For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,INDUSTRY,,,,,,,2021,1.0
NCT02831179,,2016-07-10,,,2017-09-26,2016-07-10,2016-07-13,ESTIMATED,,,,,,,2017-09-26,2017-09-28,ACTUAL,2017-12,ESTIMATED,2017-12-31,2017-09,2017-09-30,2020-02,ESTIMATED,2020-02-29,2019-02,ESTIMATED,2019-02-28,,INTERVENTIONAL,,,"Veliparib, Capecitabine, and Temozolomide in Patients With Advanced, Metastatic, and Recurrent Neuroendocrine Tumor",A Phase 1 Study of Veliparib (ABT-888) in Combination With Capecitabine and Temozolomide in Advanced Well-Differentiated Neuroendocrine Tumors,WITHDRAWN,,PHASE1,0.0,ACTUAL,Vanderbilt-Ingram Cancer Center,,1.0,,Loss of funding support,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,OTHER,,,,,,,2020,0.0
NCT04727528,,2020-12-22,2023-06-14,,2023-10-05,2021-01-26,2021-01-27,ACTUAL,2023-10-05,2023-10-06,ACTUAL,,,,2023-10-05,2023-10-06,ACTUAL,2021-03-22,ACTUAL,2021-03-22,2023-10,2023-10-31,2022-09-14,ACTUAL,2022-09-14,2022-09-14,ACTUAL,2022-09-14,,INTERVENTIONAL,NEUTRALIZE,Full analysis set,Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease,A Double-blind Randomized Placebo-controlled Parallel Design Multicenter Phase IIIb Study of the Effect of Sodium Zirconium Cyclosilicate (SZC) on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease (NEUTRALIZE),TERMINATED,,PHASE3,39.0,ACTUAL,AstraZeneca,"Due to a screening failure rate higher than expected which led to early termination of the study, only 39 (17.0%) patients entered the open-label phase. Due to the early termination of the study and small sample size, the study was underpowered for the secondary efficacy endpoints.",2.0,,The study was stopped due to a higher than expected screen fail rate (83%) which lead to very low patient enrollment into the study. It should be noted that the decision to terminate the study is not related to safety concerns.,f,,,,f,t,f,,,,,,,,,,,2024-10-17 00:23:53.073667,2024-10-17 00:23:53.073667,INDUSTRY,,,,,,,2022,0.0
NCT03887533,,2019-03-22,2022-07-11,,2022-08-02,2019-03-22,2019-03-25,ACTUAL,2022-08-02,2022-08-30,ACTUAL,,,,2022-08-02,2022-08-30,ACTUAL,2020-01-06,ACTUAL,2020-01-06,2021-10,2021-10-31,2021-10-25,ACTUAL,2021-10-25,2021-10-25,ACTUAL,2021-10-25,,INTERVENTIONAL,,,"Combined Intrathecal and Intravenous VTS-270 Therapy for Liver and Neurological Disease Associated With Niemann-Pick Disease, Type C1","Combined Intrathecal and Intravenous VTS-270 Therapy for Liver and Neurological Disease Associated With Niemann-Pick Disease, Type C1",TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,National Institutes of Health Clinical Center (CC),Enrollment was poor due to COVID-19 pandemic,2.0,,Enrollment was poor due to COVID-19 pandemic,f,,,,,t,f,,,,,,,,,,,2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,NIH,,,,,,,2021,0.0
NCT04681677,,2020-12-17,,,2024-04-24,2020-12-22,2020-12-23,ACTUAL,,,,,,,2024-04-24,2024-04-26,ACTUAL,2021-11-02,ACTUAL,2021-11-02,2024-04,2024-04-30,2024-04-24,ACTUAL,2024-04-24,2024-04-24,ACTUAL,2024-04-24,,INTERVENTIONAL,IORT,,Recurrent GBM Treated With Neurosurgical Resection and IORT Using the Xoft Axxent eBx System and Bevacizumab,Phase II Study of Patients With Recurrent Glioblastoma Multiforme Treated With Maximal Safe Neurosurgical Resection and Intra-Operative Radiation Therapy (IORT) Using the Xoft Axxent Electronic Brachytherapy System and Bevacizumab,TERMINATED,,PHASE2,12.0,ACTUAL,"Xoft, Inc.",,1.0,,unspecified business decision,f,,,,t,f,t,,,t,,,,,,NO,No IPD will be shared,2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,INDUSTRY,,,,,,,2024,0.0
NCT04611139,,2020-09-24,,,2022-02-11,2020-10-26,2020-11-02,ACTUAL,,,,,,,2022-02-11,2022-03-02,ACTUAL,2021-12-31,ESTIMATED,2021-12-31,2022-02,2022-02-28,2024-06-30,ESTIMATED,2024-06-30,2023-12-31,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Pilot Trial of SP-2577 Plus Pembrolizumab in Select Gynecologic Cancers,Pilot Feasibility and Efficacy Trial of a Novel Reversible LSD1 Inhibitor SP-2577 (Seclidemstat) Plus Pembrolizumab in Select SWI/SNF-mutant Gynecologic Cancers,WITHDRAWN,,PHASE1,0.0,ACTUAL,HonorHealth Research Institute,,1.0,,Salarius discontinued support,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 00:23:53.073667,2024-10-17 00:23:53.073667,OTHER,,,,,,,2024,0.0
NCT03585712,,2018-07-05,2021-04-06,,2021-06-02,2018-07-06,2018-07-13,ACTUAL,2021-06-02,2021-06-03,ACTUAL,,,,2021-06-02,2021-06-03,ACTUAL,2018-07-24,ACTUAL,2018-07-24,2021-06,2021-06-30,2020-04-07,ACTUAL,2020-04-07,2020-04-07,ACTUAL,2020-04-07,,INTERVENTIONAL,,All subjects enrolled in the study,"Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill","A Prospective, Multi-center, Randomized, Cross-over Study to Assess the Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill",COMPLETED,,PHASE2,52.0,ACTUAL,HRA Pharma,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 00:23:53.073667,2024-10-17 00:23:53.073667,INDUSTRY,,,,,,,2020,1.0
NCT03580356,,2018-06-26,2022-12-14,2021-08-24,2024-02-26,2018-06-26,2018-07-09,ACTUAL,2024-02-26,2024-03-25,ACTUAL,,2024-03-25,ACTUAL,2024-02-26,2024-03-25,ACTUAL,2018-10-20,ACTUAL,2018-10-20,2024-02,2024-02-29,2022-06-14,ACTUAL,2022-06-14,2021-06-22,ACTUAL,2021-06-22,,INTERVENTIONAL,,"Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.",A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.,"A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines",COMPLETED,,PHASE3,1078.0,ACTUAL,Novartis,,4.0,,,f,,,,t,t,f,,,,,,,,https://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,INDUSTRY,,,,,,,2022,1.0
NCT05481489,,2022-07-28,,,2024-06-27,2022-07-28,2022-08-01,ACTUAL,,,,,,,2024-06-27,2024-07-01,ACTUAL,2023-02-01,ESTIMATED,2023-02-01,2024-06,2024-06-30,2023-04-24,ACTUAL,2023-04-24,2023-03-31,ESTIMATED,2023-03-31,,INTERVENTIONAL,PRO-230,,Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution,Phase I Clinical Trial to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-230 When Applied to the Ocular Surface of Healthy Volunteers.,WITHDRAWN,,PHASE1,0.0,ACTUAL,Laboratorios Sophia S.A de C.V.,,1.0,,Due to sponsors convenience.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,INDUSTRY,,,,,,,2023,0.0
NCT04583592,,2020-10-07,2021-12-14,,2022-01-13,2020-10-08,2020-10-12,ACTUAL,2022-01-13,2022-01-18,ACTUAL,,,,2022-01-13,2022-01-18,ACTUAL,2020-11-09,ACTUAL,2020-11-09,2022-01,2022-01-31,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,,The Intent-to-Treat population includes all subjects who were randomized. \[Note: Subjects may have more than one risk factor upon entry into study.\],Camostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT),"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Camostat Mesilate for Treatment of COVID-19 in Outpatients",COMPLETED,,PHASE2,295.0,ACTUAL,Sagent Pharmaceuticals Inc.,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2021,1.0
NCT05764239,,2023-02-15,2024-05-24,,2024-05-24,2023-03-01,2023-03-10,ACTUAL,2024-05-24,2024-06-20,ACTUAL,,,,2024-05-24,2024-06-20,ACTUAL,2023-07-05,ACTUAL,2023-07-05,2024-05,2024-05-31,2024-03-15,ACTUAL,2024-03-15,2024-03-15,ACTUAL,2024-03-15,,INTERVENTIONAL,SYNPHENY-3,All participants who took at least 1 dose of SYNB1934v1 in the indicated study period (DEP or OLE) or who were randomized into the RWP.,Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3),"A Phase 3, Double-blind, Placebo-controlled, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)",TERMINATED,,PHASE3,35.0,ACTUAL,Synlogic,Early termination leading to small numbers of participants analyzed,4.0,,"Based on a review of interim data from participants in the dose-escalation phase, it was determined that the study was unlikely to meet the primary endpoint.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,INDUSTRY,,,,,,,2024,0.0
NCT04158583,,2019-11-05,2023-07-19,,2023-07-19,2019-11-07,2019-11-12,ACTUAL,2023-07-19,2024-03-04,ACTUAL,,,,2023-07-19,2024-03-04,ACTUAL,2019-12-09,ACTUAL,2019-12-09,2023-07,2023-07-31,2022-07-21,ACTUAL,2022-07-21,2022-07-21,ACTUAL,2022-07-21,,INTERVENTIONAL,,"Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.",A Study to Evaluate the Safety and Tolerability of RO7296682 in Participants With Advanced Solid Tumors,"An Open-Label, Multicenter Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7296682, A CD25-Targeting, T-Regulatory Cell Depleting Antibody in Participants With Advanced and/or Metastatic Solid Tumor",TERMINATED,,PHASE1,76.0,ACTUAL,Hoffmann-La Roche,,10.0,,"Halted in order to focus on the ongoing combination of RO7296682 with Atezolizumab, evaluated in study BP42595, as a higher likelihood for efficacy is expected in combination with Atezolizumab as compared to the monotherapy setting.",f,,,,,t,f,,,,,,,,,NO,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 01:54:09.353954,2024-10-15 01:54:09.353954,INDUSTRY,,,,,,,2022,0.0
NCT03875911,,2019-03-13,2023-08-16,,2024-01-03,2019-03-13,2019-03-15,ACTUAL,2024-01-03,2024-01-05,ACTUAL,,,,2024-01-03,2024-01-05,ACTUAL,2019-03-30,ACTUAL,2019-03-30,2024-01,2024-01-31,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,Not different from the assignment in Participation Flow. Participants can enroll two eyes in the study if both are eligible and trabeculectomy is recommended by the physician,Comparing Preoperative Injection of Mitomycin-C vs. Intraoperative Injection of Mitomycin-C vs. Topical Application of Mitomycin-C (Conventional Use) in Trabeculectomy,"A Prospective Randomized Clinical Trial Comparing Three Delivery Methods of Mitomycin-C for Trabeculectomy Surgery: Preoperative Subconjunctival Injection, Intraoperative Subconjunctival Injection, and Topical Application (Conventional Use) During Trabeculectomy Surgery",TERMINATED,,PHASE4,19.0,ACTUAL,"University of California, Los Angeles","COVID-19 pandemic occurred during study meaning high rates of patients lost to follow-up, as non-emergent visits were canceled or postponed. This led to early termination which means we had a small number of subjects to analyze, especially those who completed all 12 months of follow-up. By the time pandemic restrictions eased, several other studies had published results on similar trials, making further enrollment unnecessary and further supporting early termination of the study.",3.0,,"Problems unique to COVID-19, incomplete data due to a high rate of dropout to minimize non-essential appointments and difficult subject recruitment",f,,,,f,t,f,,,f,,,,,,,,2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,OTHER,,,,,eyes,,2022,0.0
NCT05462756,,2022-07-14,,,2024-08-20,2022-07-14,2022-07-18,ACTUAL,,,,,,,2024-08-20,2024-08-22,ACTUAL,2022-08-11,ACTUAL,2022-08-11,2024-08,2024-08-31,2024-02-27,ACTUAL,2024-02-27,2024-02-27,ACTUAL,2024-02-27,,INTERVENTIONAL,QWINT-4,,A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections,"A Phase 3, Parallel-Design, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adults With Type 2 Diabetes on Multiple Daily Injections",COMPLETED,,PHASE3,730.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,t,f,,,,,,,A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2024,1.0
NCT05045404,,2021-09-07,,,2023-09-11,2021-09-07,2021-09-16,ACTUAL,,,,,,,2023-09-11,2023-09-13,ACTUAL,2021-06-16,ACTUAL,2021-06-16,2023-09,2023-09-30,2023-02-02,ACTUAL,2023-02-02,2023-02-02,ACTUAL,2023-02-02,,INTERVENTIONAL,,,Poziotinib and Ramucirumab for the Treatment of EGFR Exon 20 Mutant Stage IV Non-small Cell Lung Cancer,A Phase II Study of Poziotinib and Ramucirumab in EGFR Exon 20 Mutant Advanced Non-small Cell Lung Cancer (NSCLC),WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,"Study closed due to funding, 0 patient accrual.",,,,,t,t,f,,,,,,,,,,,2024-10-17 00:23:53.073667,2024-10-17 00:23:53.073667,OTHER,,,,,,,2023,0.0
NCT02801656,,2016-06-09,,,2022-04-22,2016-06-13,2016-06-16,ESTIMATED,,,,,,,2022-04-22,2022-04-29,ACTUAL,2020-12-01,ESTIMATED,2020-12-01,2022-04,2022-04-30,2022-09-01,ESTIMATED,2022-09-01,2022-09-01,ESTIMATED,2022-09-01,,INTERVENTIONAL,,,Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea,Fecal Microbiota Transplantation for Primary Therapy in Clostridium Difficile Diarrhea - A Placebo-blinded Randomized Clinical Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,Memorial University of Newfoundland,,2.0,,Not funded,f,,,,f,f,f,,,,,,,,,YES,"After analysis is completed, data will be released",2024-10-16 02:47:50.165195,2024-10-16 02:47:50.165195,OTHER,,,,,,,2022,0.0
NCT05860075,,2023-04-26,,,2023-05-05,2023-05-05,2023-05-16,ACTUAL,,,,,,,2023-05-05,2023-05-16,ACTUAL,2019-11-19,ACTUAL,2019-11-19,2023-04,2023-04-30,2022-10-26,ACTUAL,2022-10-26,2022-10-26,ACTUAL,2022-10-26,,INTERVENTIONAL,,,Exploratory Study of IMM01 for Injection in the Treatment of Refractory or Recurrent Hematologic Malignancy,"A Phase 1 Clinical Study to Evaluate IMM01 Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity in Patients With Refractory or Recurrent Hematologic Malignancy",TERMINATED,,PHASE1,73.0,ACTUAL,ImmuneOnco Biopharmaceuticals (Shanghai) Inc.,,1.0,,No expected efficacy was observed in subsequent extended phase.The company decided to initiatively terminate the development of IMM01 as monotherapy and fully promote clinical development of combination therapy.,f,,,,t,f,f,,,,,,,,,,,2024-10-16 02:53:25.194058,2024-10-16 02:53:25.194058,OTHER,,,,,,,2022,0.0
NCT04399538,,2020-05-20,2023-03-20,,2023-03-20,2020-05-20,2020-05-22,ACTUAL,2023-03-20,2023-04-13,ACTUAL,,,,2023-03-20,2023-04-13,ACTUAL,2020-08-10,ACTUAL,2020-08-10,2023-03,2023-03-31,2022-04-28,ACTUAL,2022-04-28,2022-03-31,ACTUAL,2022-03-31,,INTERVENTIONAL,,Baseline population included all participants who were randomized and received at least 1 dose of study intervention.,Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis,"A PHASE 2A, 2-PART, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY PLACEBO-CONTROLLED, PARALLEL-GROUP (SPONSOR OPEN) STUDY TO ASSESS PHARMACODYNAMICS AND SAFETY OF PF-06865571 (DGAT2I) COADMINISTERED WITH PF-05221304 (ACCI) IN ADULT PARTICIPANTS WITH PRESUMED NONALCOHOLIC STEATOHEPATITIS (NASH)",COMPLETED,,PHASE2,75.0,ACTUAL,Pfizer,,5.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 00:23:53.073667,2024-10-17 00:23:53.073667,INDUSTRY,,,,,,,2022,1.0
NCT03881059,,2019-03-18,2021-04-23,,2022-01-25,2019-03-18,2019-03-19,ACTUAL,2021-04-23,2021-05-17,ACTUAL,,,,2022-01-25,2022-02-15,ACTUAL,2019-04-01,ACTUAL,2019-04-01,2022-01,2022-01-31,2021-01-27,ACTUAL,2021-01-27,2020-04-27,ACTUAL,2020-04-27,,INTERVENTIONAL,,All treated participants,Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA),"A Randomized, Placebo-Controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Multiple Doses of BMS-986165 in Subjects With Active Psoriatic Arthritis (PsA)",COMPLETED,,PHASE2,203.0,ACTUAL,Bristol-Myers Squibb,,6.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,INDUSTRY,,,,,,,2021,1.0
NCT04348292,,2020-02-20,2024-03-29,,2024-08-19,2020-04-13,2020-04-16,ACTUAL,2024-08-19,2024-08-22,ACTUAL,,,,2024-08-19,2024-08-22,ACTUAL,2021-01-22,ACTUAL,2021-01-22,2024-08,2024-08-31,2022-11-04,ACTUAL,2022-11-04,2022-11-04,ACTUAL,2022-11-04,,INTERVENTIONAL,,diagnosed with Resectable Non-small Cell Lung Cancer,Sirolimus and Durvalumab for the Treatment of Stage I-IIIA Non-small Cell Lung Cancer,A Phase 1b Neoadjuvant Trial of Sirolimus Followed by Durvalumab (MEDI4736) in Resectable Non-small Cell Lung Cancer,TERMINATED,,PHASE1,3.0,ACTUAL,Emory University,"This was a low accruing trial which amassed fewer patients than anticipated. Due to stalled enrollment, the study was terminated and did not reach completion.",1.0,,Accrual goal not met.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,OTHER,,,,,,,2022,0.0
NCT04278872,,2020-02-18,2021-08-17,,2021-11-12,2020-02-18,2020-02-20,ACTUAL,2021-11-12,2022-01-11,ACTUAL,,,,2021-11-12,2022-01-11,ACTUAL,2020-11-09,ACTUAL,2020-11-09,2021-11,2021-11-30,2021-04-07,ACTUAL,2021-04-07,2021-02-12,ACTUAL,2021-02-12,,INTERVENTIONAL,,,Phase 2 Study of SJX-653 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms,"A Phase 2, Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of SJX-653 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms",TERMINATED,,PHASE2,13.0,ACTUAL,"Sojournix, Inc.",,2.0,,The study was terminated early as the goal of determining a safe and efficacious dose for further development for the treatment of VMS was not met,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2021,0.0
NCT04560868,,2020-06-15,2022-09-26,,2023-01-03,2020-09-17,2020-09-23,ACTUAL,2023-01-03,2023-01-23,ACTUAL,,,,2023-01-03,2023-01-23,ACTUAL,2020-12-16,ACTUAL,2020-12-16,2023-01,2023-01-31,2021-09-27,ACTUAL,2021-09-27,2021-09-27,ACTUAL,2021-09-27,,INTERVENTIONAL,,,Development of a mHealth Intervention for Ambivalent Smokers,Development of a mHealth Intervention for Ambivalent Smokers,COMPLETED,,PHASE1,57.0,ACTUAL,Kaiser Permanente,The purpose of this pilot was to inform feasibility and acceptability of the experimental app among smokers who were ambivalent about quitting. Data were analyzed among participants who installed the app (n = 57). This pilot study was not powered to provide definitive answers about the efficacy of the intervention in promoting smoking abstinence. A larger trial is needed for this.,2.0,,,f,,,,f,f,f,,,,,,,,,NO,Data will not be shared.,2024-10-17 00:23:53.073667,2024-10-17 00:23:53.073667,OTHER,,,,,,,2021,1.0
NCT04662086,,2020-12-08,2023-05-02,,2023-06-09,2020-12-09,2020-12-10,ACTUAL,2023-05-02,2023-05-30,ACTUAL,,,,2023-06-09,2023-06-28,ACTUAL,2021-04-23,ACTUAL,2021-04-23,2023-06,2023-06-30,2023-02-02,ACTUAL,2023-02-02,2022-05-03,ACTUAL,2022-05-03,,INTERVENTIONAL,,,COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Master Protocol,"COVID-19 Outpatient Pragmatic Platform Study (COPPS): A Pragmatic Multi-arm, Adaptive, Phase 2, Blinded, Randomized Placebo-controlled Platform Trial to Assess the Efficacy of Different Investigational Therapeutics in Reducing Time to Disease Resolution or Viral Load Cessation, as Compared to Standard Supportive Care in Outpatients With COVID-19",COMPLETED,,PHASE2,122.0,ACTUAL,Stanford University,This camostat arm did not meet its planned enrollment and did not achieve statistical power as specified in the protocol.,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,OTHER,,,,,,,2023,1.0
NCT03423147,,2018-01-31,2023-02-23,2022-02-10,2023-02-23,2018-01-31,2018-02-06,ACTUAL,2023-02-23,2023-03-23,ACTUAL,2022-02-10,2022-02-17,ACTUAL,2023-02-23,2023-03-23,ACTUAL,2018-10-05,ACTUAL,2018-10-05,2022-02,2022-02-28,2021-02-11,ACTUAL,2021-02-11,2021-02-11,ACTUAL,2021-02-11,,INTERVENTIONAL,PRACTICAL,,Preoperative Application of Chlorhexidine to Reduce Infection With Cesarean Section After Labor,A Randomized Trial to Determine if a Pre-operative Wash With a Chlorhexidine Gluconate Cloth and Chlorhexidine Gluconate Vaginal Scrub Reduces Infectious Morbidity in Patients Undergoing Cesarean Section After Labor,TERMINATED,,PHASE2,319.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,2.0,,"Poor enrollment, inability to achieve required number of subjects",f,,,,f,t,f,,,,,,,,,,,2024-10-17 00:23:53.073667,2024-10-17 00:23:53.073667,OTHER,,,,,,,2021,0.0
NCT02410239,,2015-03-27,,,2017-11-29,2015-04-01,2015-04-07,ESTIMATED,,,,,,,2017-11-29,2017-12-02,ACTUAL,2015-06,ESTIMATED,2015-06-30,2017-11,2017-11-30,2022-07,ESTIMATED,2022-07-31,2017-07,ESTIMATED,2017-07-31,,INTERVENTIONAL,,,MT2014-14 IT-MSC for Advanced Cerebral Adrenoleukodystrophy (cALD),MT2014-14 Intrathecal Administration of Mesenchymal Stem Cells (IT-MSC) for the Treatment of Advanced Cerebral Adrenoleukodystrophy (cALD),WITHDRAWN,,PHASE1,0.0,ACTUAL,"Masonic Cancer Center, University of Minnesota",,1.0,,Research cancelled,f,,,,t,,,,,,,,,,,,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,OTHER,,,,,,,2022,0.0
NCT02771197,,2016-03-22,2023-08-25,,2023-09-22,2016-05-10,2016-05-13,ESTIMATED,2023-09-21,2023-09-22,ACTUAL,,,,2023-09-22,2023-09-28,ACTUAL,2016-09-28,ACTUAL,2016-09-28,2023-09,2023-09-30,2023-07-31,ACTUAL,2023-07-31,2022-08-03,ACTUAL,2022-08-03,,INTERVENTIONAL,,,Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in AML Patient Not Eligible for Transplant,Phase II Trial of Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in High Risk AML Patients Who Are Not Eligible for Allogeneic Stem Cell Transplantation,COMPLETED,,PHASE2,20.0,ACTUAL,"Northside Hospital, Inc.",,1.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,OTHER,,,,,,,2023,1.0
NCT03882970,,2019-03-19,2021-12-02,,2022-01-14,2019-03-19,2019-03-20,ACTUAL,2022-01-14,2022-01-19,ACTUAL,,,,2022-01-14,2022-01-19,ACTUAL,2019-04-01,ACTUAL,2019-04-01,2022-01,2022-01-31,2021-01-04,ACTUAL,2021-01-04,2020-12-11,ACTUAL,2020-12-11,,INTERVENTIONAL,SURPASS-3,All randomized participants.,A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes,"A Randomized, Phase 3, Open-Label Trial Comparing the Effect of LY3298176 Versus Titrated Insulin Degludec on Glycemic Control in Patients With Type 2 Diabetes",COMPLETED,,PHASE3,1444.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 02:53:25.194058,2024-10-16 02:53:25.194058,INDUSTRY,,,,,,,2021,1.0
NCT02759835,,2016-04-06,2023-05-10,,2024-05-13,2016-05-02,2016-05-03,ESTIMATED,2023-06-30,2023-07-25,ACTUAL,,,,2024-05-13,2024-06-07,ACTUAL,2016-04-13,ACTUAL,2016-04-13,2024-05,2024-05-31,2022-09-20,ACTUAL,2022-09-20,2022-05-25,ACTUAL,2022-05-25,,INTERVENTIONAL,,,"Local Ablative Therapy for Treatment of Oligoprogressive, EGFR-Mutated, Non-Small Cell Lung Cancer After Treatment With Osimertinib","A Pilot Study of Local Ablative Therapy for Treatment of Oligoprogressive, EGFR-mutated, Non-Small Cell Lung Cancer (NSCLC) After Treatment With Osimertinib (AZD9291, Tagrisso)",COMPLETED,,PHASE2,37.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,,f,,,,f,t,f,,,f,,,Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing Plan (GDS) plan for as long as database is active.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.,,YES,"All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).",2024-10-17 00:23:53.073667,2024-10-17 00:23:53.073667,NIH,,,,,,,2022,1.0
NCT03056014,,2017-01-30,,,2022-03-07,2017-02-13,2017-02-16,ACTUAL,,,,,,,2022-03-07,2022-03-22,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2022-03,2022-03-31,2020-03-12,ACTUAL,2020-03-12,2020-03-12,ACTUAL,2020-03-12,,INTERVENTIONAL,,,Antioxidant Use in Diabetes to Reduce Oxidative Stress,Supplementation of N-acetylcysteine and Arachonic Acid in Type 1 Diabetes to Determine Changes in Oxidative Stress,TERMINATED,,EARLY_PHASE1,8.0,ACTUAL,"University of Maryland, Baltimore",,6.0,,COVID,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 00:23:53.073667,2024-10-17 00:23:53.073667,OTHER,,,,,,,2020,0.0
NCT03387514,,2017-12-22,2022-09-30,2022-06-29,2022-12-01,2017-12-22,2018-01-02,ACTUAL,2022-12-01,2022-12-21,ACTUAL,2022-12-01,2022-12-21,ACTUAL,2022-12-01,2022-12-21,ACTUAL,2018-12-08,ACTUAL,2018-12-08,2022-12,2022-12-31,2021-06-29,ACTUAL,2021-06-29,2021-06-29,ACTUAL,2021-06-29,,INTERVENTIONAL,UW17104,,Functional Microscale Organotypic Assays to Predict Patient Response to Anti-Angiogenesis Therapies,Functional Microscale Organotypic Assays to Predict Patient Response to Anti-Angiogenesis Therapies,TERMINATED,,PHASE2,5.0,ACTUAL,"University of Wisconsin, Madison","Due to change in standard of care system therapy to immune therapy during the course of this trial, patients did not proceed to anti-angiogenesis therapy or combined anti-angiogenesis therapy with immune therapy to allow for further PET or CT maging timepoints during the follow-up period of this trial. Therefore RECIST 1.1 response could not be assessed but PET SUVmax data is provided. Due to low enrollment for this issue, the study funding did not continue to allow for further study data.",1.0,,Termination of funding due to low subject enrollment due to change in standard of care systemic therapy which limited available patients treated with anti-angiogenesis or combined immune and anti-angiogenesis therapy for enrollment.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 15:37:05.552998,2024-10-15 15:37:05.552998,OTHER,,,,,,,2021,0.0
NCT04980391,,2021-07-20,2023-11-28,,2024-01-11,2021-07-20,2021-07-28,ACTUAL,2024-01-11,2024-02-06,ACTUAL,,,,2024-01-11,2024-02-06,ACTUAL,2021-08-03,ACTUAL,2021-08-03,2024-01,2024-01-31,2023-05-30,ACTUAL,2023-05-30,2023-05-30,ACTUAL,2023-05-30,,INTERVENTIONAL,,,"A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers","A Phase III, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Reactogenicity and Immune Response of a Single Intramuscular Dose of Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers",TERMINATED,,PHASE3,384.0,ACTUAL,GlaxoSmithKline,,4.0,,"Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study.",f,,,,t,t,f,,,f,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2023,0.0
NCT04505592,,2020-08-06,2023-03-08,,2023-04-04,2020-08-06,2020-08-10,ACTUAL,2023-04-04,2023-04-06,ACTUAL,,,,2023-04-04,2023-04-06,ACTUAL,2020-09-25,ACTUAL,2020-09-25,2023-04,2023-04-30,2022-03-10,ACTUAL,2022-03-10,2022-03-10,ACTUAL,2022-03-10,,INTERVENTIONAL,,,Tenecteplase in Patients With COVID-19,Tenecteplase With Concomitant Anticoagulation for Severe Acute Respiratory Failure in Patients With COVID-19,COMPLETED,,PHASE2,13.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,OTHER,,,,,,,2022,0.0
NCT03522207,,2018-04-16,,,2020-02-03,2018-04-30,2018-05-11,ACTUAL,,,,,,,2020-02-03,2020-02-05,ACTUAL,2018-10-15,ACTUAL,2018-10-15,2020-02,2020-02-29,2020-01-20,ACTUAL,2020-01-20,2020-01-20,ACTUAL,2020-01-20,,INTERVENTIONAL,,,Accuracy and Efficacy of Trazodone (Desyrel) on Sleep Quality and Pain Management of TMD Patient,Stabilisation de la qualité du Sommeil Chez le Sujet en Douleurs Orofaciales Chroniques - étude expérimentale en chassé croisé : Trazodone/ Placebo,TERMINATED,,PHASE4,3.0,ACTUAL,Centre hospitalier de l'Université de Montréal (CHUM),,2.0,,shortstaff at sleep lab,f,,,,f,f,f,,,f,,,,,,,,2024-10-17 00:23:53.073667,2024-10-17 00:23:53.073667,OTHER,,,,,,,2020,0.0
NCT03209973,,2017-05-25,2020-08-12,,2021-10-18,2017-07-04,2017-07-06,ACTUAL,2020-09-17,2020-10-12,ACTUAL,,,,2021-10-18,2021-11-18,ACTUAL,2017-04-21,ACTUAL,2017-04-21,2021-10,2021-10-31,2020-11-02,ACTUAL,2020-11-02,2020-11-02,ACTUAL,2020-11-02,,INTERVENTIONAL,,Safety Analysis Set: All participants who received any dose of study drug.,A Study of Tislelizumab as Monotherapy in Relapsed or Refractory Classical Hodgkin Lymphoma,"A Single Arm, Multicenter, Phase 2 Study of BGB-A317 as Monotherapy in Relapsed or Refractory Classical Hodgkin Lymphoma",COMPLETED,,PHASE2,70.0,ACTUAL,BeiGene,,1.0,,,f,,,,f,f,f,,,,,,,,,YES,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2020,1.0
NCT02184195,,2014-06-06,2020-01-14,,2023-08-18,2014-07-03,2014-07-09,ESTIMATED,2020-01-14,2020-01-27,ACTUAL,,,,2023-08-18,2023-09-13,ACTUAL,2014-12-16,ACTUAL,2014-12-16,2023-06,2023-06-30,2023-01-27,ACTUAL,2023-01-27,2019-01-15,ACTUAL,2019-01-15,,INTERVENTIONAL,POLO,Full analysis set consisted of all randomised patients analysed on an intent to treat basis.,Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy,"A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy",COMPLETED,,PHASE3,154.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,,,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-16 02:53:25.194058,2024-10-16 02:53:25.194058,INDUSTRY,,,,,,,2023,1.0
NCT05130086,,2021-11-10,,,2022-10-13,2021-11-10,2021-11-22,ACTUAL,,,,,,,2022-10-13,2022-10-17,ACTUAL,2022-10-17,ESTIMATED,2022-10-17,2022-10,2022-10-31,2024-03-25,ESTIMATED,2024-03-25,2024-03-25,ESTIMATED,2024-03-25,,INTERVENTIONAL,,,A Study of Islatravir (MK-8591) in Trans and Gender Diverse Participants (MK-8591-035),A Phase 2 Open-Label Study to Evaluate the Safety and Pharmacokinetics of Oral Islatravir Once-Monthly in Trans and Gender Diverse Individuals on Gender-Affirming Hormone Therapy and at Low-Risk for HIV-1 Infection,WITHDRAWN,,PHASE2,0.0,ACTUAL,Merck Sharp & Dohme LLC,,1.0,,Business Reasons,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2024,0.0
NCT04542330,,2020-09-07,2024-03-26,,2024-03-26,2020-09-07,2020-09-09,ACTUAL,2024-03-26,2024-08-22,ACTUAL,,,,2024-03-26,2024-08-22,ACTUAL,2020-09-15,ACTUAL,2020-09-15,2024-03,2024-03-31,2023-01-11,ACTUAL,2023-01-11,2023-01-11,ACTUAL,2023-01-11,,INTERVENTIONAL,,,Using BCG to Protect Senior Citizens During the COVID-19 Pandemic,Using BCG Vaccine to Enhance Non-specific Protection of Senior Citizens During the COVID-19 Pandemic. A Randomized Clinical Trial.,COMPLETED,,PHASE3,1700.0,ACTUAL,Bandim Health Project,,2.0,,,f,,,,t,f,f,,,,,,When follow-up has been completed and the dataset have been closed,Per justified request on email (cbenn@health.sdu.dk),,YES,Non-identifiable individual data can be shared on the basis of a data sharing proposal sent to cbenn@health.sdu.dk,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,OTHER,,,,,,,2023,1.0
NCT05757648,,2023-02-23,2024-05-06,,2024-06-21,2023-02-23,2023-03-07,ACTUAL,2024-06-21,2024-07-17,ACTUAL,,,,2024-06-21,2024-07-17,ACTUAL,2020-12-08,ACTUAL,2020-12-08,2024-06,2024-06-30,2023-06-12,ACTUAL,2023-06-12,2023-06-12,ACTUAL,2023-06-12,,INTERVENTIONAL,,,Buffered Local Anesthetic,"Effect of Buffered Anesthetic on Physiological Reactions During Dental Injection in Young Children Under Deep Sedation: A Prospective, Single Visit, Randomized, Double-Blind Split Mouth Study",COMPLETED,,PHASE4,20.0,ACTUAL,University Hospitals Cleveland Medical Center,,1.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,OTHER,,,,,,,2023,1.0
NCT03285165,,2017-09-14,,,2020-07-13,2017-09-14,2017-09-15,ACTUAL,,,,,,,2020-07-13,2020-07-14,ACTUAL,2017-09-14,ACTUAL,2017-09-14,2020-07,2020-07-31,2021-09-16,ESTIMATED,2021-09-16,2021-09-16,ESTIMATED,2021-09-16,,INTERVENTIONAL,DEXSEDATION,,Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients,Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients With and Without Traumatic Brain Injury.,SUSPENDED,,PHASE2/PHASE3,60.0,ESTIMATED,Assiut University,,4.0,,NO AVAILABLE FUND,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,OTHER,,,,,,,2021,0.0
NCT05134727,,2021-11-15,,,2024-05-14,2021-11-15,2021-11-26,ACTUAL,,,,,,,2024-05-14,2024-05-16,ACTUAL,2021-11-18,ACTUAL,2021-11-18,2024-05,2024-05-31,2023-03-31,ACTUAL,2023-03-31,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,,,"Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 Following Single and Multiple Ascending Doses in Healthy Participants","A Double-blind, Randomized, Placebo-controlled Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of Oral AZD5055 Following Single and Multiple Ascending Doses",COMPLETED,,PHASE1,63.0,ACTUAL,AstraZeneca,,2.0,,,,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in a sponsor approved tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2023,1.0
NCT04229771,,2020-01-09,2022-11-22,,2022-12-21,2020-01-13,2020-01-18,ACTUAL,2022-12-21,2023-01-19,ACTUAL,,,,2022-12-21,2023-01-19,ACTUAL,2020-06-30,ACTUAL,2020-06-30,2022-12,2022-12-31,2020-11-30,ACTUAL,2020-11-30,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,,No participants randomized to the group Participants who received proparacaine hydrochoride solution in the right eye and placebo in the left eye.,Does Topical Ophthalmic Anesthetic Prior to Probing and Irrigation Decrease Pain?,Does Administration of Proparacaine Hydrochloride 0.5% Ophthalmic Solution Prior to Canalicular Probing and Irrigation Decrease Patient Discomfort,TERMINATED,,PHASE4,2.0,ACTUAL,William Beaumont Hospitals,,2.0,,slow enrollment,f,,,,f,t,f,,,t,,,,,,NO,No individual participant data to be shared,2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,OTHER,,,,,eyes,,2020,0.0
NCT04074330,,2019-08-28,2024-03-26,,2024-05-17,2019-08-28,2019-08-30,ACTUAL,2024-05-17,2024-06-14,ACTUAL,,,,2024-05-17,2024-06-14,ACTUAL,2019-10-15,ACTUAL,2019-10-15,2024-05,2024-05-31,2023-04-26,ACTUAL,2023-04-26,2023-04-26,ACTUAL,2023-04-26,,INTERVENTIONAL,,"Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.",A Study of TAK-981 Given With Rituximab in Adults With Relapsed or Refractory CD20-Positive Non-Hodgkin Lymphoma,Phase 1/2 Study of TAK-981 in Combination With Rituximab in Patients With Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma,TERMINATED,,PHASE1/PHASE2,38.0,ACTUAL,Takeda,The study was terminated due to enrollment challenges.,10.0,,Enrolment Challenges,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,INDUSTRY,,,,,,,2023,0.0
NCT05219513,,2021-11-23,,,2024-08-22,2022-01-20,2022-02-02,ACTUAL,,,,,,,2024-08-22,2024-08-23,ACTUAL,2022-02-18,ACTUAL,2022-02-18,2024-08,2024-08-31,2024-07-17,ACTUAL,2024-07-17,2024-07-17,ACTUAL,2024-07-17,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma","An Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma",TERMINATED,,PHASE1,53.0,ACTUAL,Hoffmann-La Roche,,2.0,,The study was terminated due to sponsor portfolio re-alignment.,f,,,,,t,f,,,,,,,,,NO,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)",2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2024,0.0
NCT04388176,,2020-05-11,2022-01-17,,2022-07-21,2020-05-13,2020-05-14,ACTUAL,2022-07-21,2023-05-18,ACTUAL,,,,2022-07-21,2023-05-18,ACTUAL,2020-01-03,ACTUAL,2020-01-03,2022-07,2022-07-31,2020-12-14,ACTUAL,2020-12-14,2020-12-14,ACTUAL,2020-12-14,,INTERVENTIONAL,,,Cold Challenge With C21 in RP,"A Phase 2, Single-center, Randomised, Double-blind, Placebo-controlled, Cross-over Cold Challenge Study Investigating the Effect of C21 on Cold-induced Vasoconstriction in Subjects With Raynaud's Phenomenon (RP) Secondary to Systemic Sclerosis (SSc)",COMPLETED,,PHASE2,20.0,ACTUAL,Vicore Pharma AB,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,INDUSTRY,,,,,,,2020,1.0
NCT04905121,,2021-05-06,,,2022-10-10,2021-05-24,2021-05-27,ACTUAL,,,,,,,2022-10-10,2022-10-12,ACTUAL,2021-08-11,ACTUAL,2021-08-11,2022-10,2022-10-31,2022-04-22,ACTUAL,2022-04-22,2022-04-22,ACTUAL,2022-04-22,,INTERVENTIONAL,,,Phase 1b Study in Patients With Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA),"An Exploratory Open-Label, Phase 1b, Ascending Dose Study to Evaluate the Effects of Oral 3-[2-(Dimethylamino)Ethyl]-1h-indol-4-yl Dihydrogen Phosphate (Psilocybin, BPL-PSILO) on Cognition in Patients With Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)",TERMINATED,,PHASE1,4.0,ACTUAL,Beckley Psytech Limited,,1.0,,Unable to recruit patient population,f,,,,f,f,f,,,,,,,,,NO,"Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion.",2024-10-16 02:53:25.194058,2024-10-16 02:53:25.194058,INDUSTRY,,,,,,,2022,0.0
NCT03118232,,2017-02-21,2023-11-09,,2023-12-05,2017-04-14,2017-04-18,ACTUAL,2023-12-05,2023-12-27,ACTUAL,,,,2023-12-05,2023-12-27,ACTUAL,2017-04-03,ACTUAL,2017-04-03,2023-12,2023-12-31,2023-10-10,ACTUAL,2023-10-10,2023-10-10,ACTUAL,2023-10-10,,INTERVENTIONAL,PROTECT,,Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization,Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization,COMPLETED,,PHASE4,13952.0,ACTUAL,"University of California, Irvine",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,"The resource sharing plan involves sharing 1) sharing of trial materials and tools, and 2) making bacterial isolates available.",2024-10-16 02:53:25.194058,2024-10-16 02:53:25.194058,OTHER,,,,,,,2023,1.0
NCT03727841,,2018-10-31,2021-10-08,,2022-07-06,2018-10-31,2018-11-01,ACTUAL,2021-11-01,2021-11-30,ACTUAL,,,,2022-07-06,2022-07-27,ACTUAL,2020-01-22,ACTUAL,2020-01-22,2022-07,2022-07-31,2021-04-30,ACTUAL,2021-04-30,2021-04-30,ACTUAL,2021-04-30,,INTERVENTIONAL,,,"Marizomib for Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial, and Spinal Cord Ependymoma","Phase II Clinical Trial of Marizomib for Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial and Spinal Cord Ependymoma",TERMINATED,,PHASE2,4.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,"The pharmaceutical company decided to close their program evaluating the study agent, Marizomib.",f,,,,f,t,f,,,,,,BTRIS: Clinical data available during the study and indefinitely. dbGaP: Genomic data are available once genomic data are uploaded per protocol genomic data sharing (GDS) plan for as long as database is active.,BTRIS: Clinical data will be made available via subscription to BTRIS and with the permission of the study principal investigator (PI).~dbGaP: Genomic data are made available via dbGaP through requests to the data custodians.,,YES,"1. Biomedical Translational Research Information System (BTRIS): All IPD recorded in the medical record will be shared with intramural investigators upon request.~2. Database of Genotypes and Phenotypes (dbGaP): All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.",2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,NIH,,,,,,,2021,0.0
NCT03669640,,2018-09-12,2024-03-08,,2024-08-06,2018-09-12,2018-09-13,ACTUAL,2024-08-06,2024-08-12,ACTUAL,,,,2024-08-06,2024-08-12,ACTUAL,2018-12-04,ACTUAL,2018-12-04,2024-08,2024-08-31,2023-03-12,ACTUAL,2023-03-12,2023-03-12,ACTUAL,2023-03-12,,INTERVENTIONAL,,,A Study to Assess the Effects of RO6889450 (Ralmitaront) in Participants With Schizophrenia or Schizoaffective Disorder and Negative Symptoms,"Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of RO6889450 (Ralmitaront) in Patients With Schizophrenia or Schizoaffective Disorder and Negative Symptoms",TERMINATED,,PHASE2,131.0,ACTUAL,Hoffmann-La Roche,,2.0,,This study was discontinued due to an interim analysis which indicated that ralmitaront was unlikely to meet its primary endpoint.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2023,0.0
NCT04527549,,2020-08-24,2024-07-09,,2024-08-16,2020-08-24,2020-08-26,ACTUAL,2024-08-16,2024-08-22,ACTUAL,,,,2024-08-16,2024-08-22,ACTUAL,2021-06-01,ACTUAL,2021-06-01,2024-07,2024-07-31,2024-01-08,ACTUAL,2024-01-08,2024-01-08,ACTUAL,2024-01-08,,INTERVENTIONAL,,,Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma,"The BAMM2 (BRAF, Autophagy, MEK Inhibition in Melanoma) Study: A Randomized Double Blind Phase II Study of Dabrafenib and Trametinib With or Without Hydroxychloroquine in Advanced BRAF V600E/K Melanoma With Elevated LDH",TERMINATED,,PHASE2,5.0,ACTUAL,Eastern Cooperative Oncology Group,,2.0,,Slow accrual,f,,,,t,t,f,,,,,,,,,YES,Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,NETWORK,,,,,,,2024,0.0
NCT05248880,,2022-02-14,,2024-01-08,2024-01-08,2022-02-14,2022-02-21,ACTUAL,,,,,2024-01-10,ACTUAL,2024-01-08,2024-01-10,ACTUAL,2022-03-08,ACTUAL,2022-03-08,2024-01,2024-01-31,2023-02-01,ACTUAL,2023-02-01,2023-02-01,ACTUAL,2023-02-01,,INTERVENTIONAL,,,A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines,A Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of AGN-151586 for the Treatment of Glabellar Lines in Toxin-Naïve Subjects,COMPLETED,,PHASE3,309.0,ACTUAL,Allergan,,2.0,,,f,,,,f,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,INDUSTRY,,,,,,,2023,0.0
NCT03632798,,2018-08-13,,,2024-08-20,2018-08-13,2018-08-15,ACTUAL,,,,,,,2024-08-20,2024-08-22,ACTUAL,2018-08-01,ACTUAL,2018-08-01,2024-08,2024-08-31,2024-12-30,ESTIMATED,2024-12-30,2024-12-30,ESTIMATED,2024-12-30,,INTERVENTIONAL,ACSCO,,Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Ovarian Cancer,"Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients With Recurrent Platinum-Resistant or -Sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer",SUSPENDED,,PHASE3,300.0,ESTIMATED,"Cordgenics, LLC",,2.0,,Slow enrollment,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2024,0.0
NCT04611152,,2020-10-19,2024-07-25,,2024-08-20,2020-10-26,2020-11-02,ACTUAL,2024-08-20,2024-08-22,ACTUAL,,,,2024-08-20,2024-08-22,ACTUAL,2020-09-30,ACTUAL,2020-09-30,2024-08,2024-08-31,2023-08-31,ACTUAL,2023-08-31,2023-05-11,ACTUAL,2023-05-11,,INTERVENTIONAL,GLEAM,Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or aflibercept). Subjects will be analyzed according to their randomized treatment.,"A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)","A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME)",TERMINATED,,PHASE3,460.0,ACTUAL,Kodiak Sciences Inc,,2.0,,Study did not meet primary endpoint,f,,,,t,t,f,,,,,,,,,,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2023,0.0
NCT03332212,,2017-11-02,2021-05-26,,2021-05-26,2017-11-02,2017-11-06,ACTUAL,2021-05-26,2021-06-18,ACTUAL,,,,2021-05-26,2021-06-18,ACTUAL,2018-03-01,ACTUAL,2018-03-01,2021-05,2021-05-31,2020-05-28,ACTUAL,2020-05-28,2020-05-21,ACTUAL,2020-05-21,,INTERVENTIONAL,,"Randomised set (RS): This set included all patients who were randomised to study treatment, in line with the intention-to-treat principle.",A Study That Looks at the Function of the Heart in Patients With Heart Failure Who Take Empagliflozin,"EMPA-VISION: A Randomised, Double-blind, Placebo-controlled, Mechanistic Cardiac Magnetic Resonance Study to Investigate the Effects of Empagliflozin Treatment on Cardiac Physiology and Metabolism in Patients With Heart Failure",COMPLETED,,PHASE3,72.0,ACTUAL,Boehringer Ingelheim,"Due to the suspension of face-to-face contact imposed in March 2020 to restrict transmission of COVID-19, the number of patients included in the analysis of efficacy for the Heart failure with preserved ejection fraction was substantially reduced, which meant that this cohort was also under powered (reduced from 80% to 70%) for the planned analysis of the primary endpoint.",2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2020,1.0
NCT04501952,,2020-08-05,2021-11-04,,2021-11-04,2020-08-05,2020-08-06,ACTUAL,2021-11-04,2021-11-16,ACTUAL,,,,2021-11-04,2021-11-16,ACTUAL,2020-09-18,ACTUAL,2020-09-18,2021-11,2021-11-30,2021-05-06,ACTUAL,2021-05-06,2021-05-06,ACTUAL,2021-05-06,,INTERVENTIONAL,,Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment.,Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting,"A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of COVID-19 in an Outpatient Setting",TERMINATED,,PHASE3,584.0,ACTUAL,Gilead Sciences,,2.0,,The study was terminated due to study enrollment feasibility and changing needs of non-hospitalized participants. This decision is not based on efficacy or safety concerns.,t,,,,t,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.",2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,INDUSTRY,,NCT04323761,APPROVED_FOR_MARKETING,,,,2021,0.0
NCT02498977,,2015-06-11,,,2024-03-05,2015-07-14,2015-07-15,ESTIMATED,,,,,,,2024-03-05,2024-03-07,ACTUAL,2015-10,ACTUAL,2015-10-31,2024-03,2024-03-31,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,LIFT,,Liver Immunosuppression Free Trial,Prospective Randomised Marker-based Trial to Assess the Clinical Utility and Safety of Biomarker-guided Immunosuppression Withdrawal in Liver Transplantation,TERMINATED,,PHASE4,116.0,ACTUAL,King's College London,,3.0,,Primary endpoint not reached.,f,,,,t,,,,,,,,,,,,,2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,OTHER,,,,,,,2021,0.0
NCT02296671,,2014-11-18,,,2016-03-07,2014-11-19,2014-11-20,ESTIMATED,,,,,,,2016-03-07,2016-03-08,ESTIMATED,2015-02,,2015-02-28,2016-03,2016-03-31,2022-02,ESTIMATED,2022-02-28,2018-09,ESTIMATED,2018-09-30,,INTERVENTIONAL,,,Personalized Therapy for Esophagogastric Cancer Using Thymidylate Synthase Genetic Markers,Personalized Therapy for Esophagogastric Cancer Using Thymidylate Synthase Genetic Markers,WITHDRAWN,,PHASE2,0.0,ACTUAL,Washington University School of Medicine,,2.0,,Was unable to accrue any patients,f,,,,t,,,,,,,,,,,,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,OTHER,,,,,,,2022,0.0
NCT04441788,,2020-06-18,2022-11-24,,2022-11-24,2020-06-18,2020-06-22,ACTUAL,2022-11-24,2022-12-20,ACTUAL,,,,2022-11-24,2022-12-20,ACTUAL,2020-12-22,ACTUAL,2020-12-22,2022-11,2022-11-30,2021-08-09,ACTUAL,2021-08-09,2021-04-27,ACTUAL,2021-04-27,,INTERVENTIONAL,,Safety population included all the participants who were randomized and received at least 1 dose of study drug.,"A Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Participants With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis (CB)","A Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Patients With Mild to Moderate COPD With Chronic Bronchitis",TERMINATED,,PHASE2,60.0,ACTUAL,"Ionis Pharmaceuticals, Inc.","The study was terminated based on the toxicology findings from a 9-month study and participants who had not completed the treatment period were instructed to terminate dosing and return for an end of study visit, followed by the 10-week follow-up period.",3.0,,Business Decision to Terminate Study,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,INDUSTRY,,,,,,,2021,0.0
NCT04408664,,2020-05-19,,,2023-08-01,2020-05-28,2020-05-29,ACTUAL,,,,,,,2023-08-01,2023-08-03,ACTUAL,2021-04-06,ACTUAL,2021-04-06,2023-08,2023-08-31,2023-08-01,ACTUAL,2023-08-01,2023-06-28,ACTUAL,2023-06-28,,INTERVENTIONAL,,,Influence of Cromones on Eucapnic Hyperventilation (EVH)-Test in Young (Elite) Athletes Who Tested Positive for EIB.,WP3-Influence of Cromones on EVH-test in Young (Elite) Athletes Who Tested Positive for EIB (=Exercise Induced Bronchoconstriction),TERMINATED,,PHASE3,8.0,ACTUAL,Universitaire Ziekenhuizen KU Leuven,,2.0,,Insufficient accrual rate,f,,,,f,f,f,,,f,,,,,,NO,data will be analysed and grouped before release,2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,OTHER,,,,,,,2023,0.0
NCT03934216,,2019-04-30,2022-06-09,,2024-02-09,2019-04-30,2019-05-01,ACTUAL,2022-06-09,2022-07-06,ACTUAL,,,,2024-02-09,2024-03-06,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2024-02,2024-02-29,2023-04-04,ACTUAL,2023-04-04,2021-06-13,ACTUAL,2021-06-13,,INTERVENTIONAL,,,Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis",COMPLETED,,PHASE2,131.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,INDUSTRY,,,,,,,2023,1.0
NCT04847583,,2021-04-14,,,2022-02-12,2021-04-14,2021-04-19,ACTUAL,,,,,,,2022-02-12,2022-03-02,ACTUAL,2021-07-29,ACTUAL,2021-07-29,2021-04,2021-04-30,2022-02-11,ACTUAL,2022-02-11,2022-02-11,ACTUAL,2022-02-11,,INTERVENTIONAL,,,"A Phase 2 Study to Evaluate Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec (Q203) in Covid-19 Patients","A Phase 2 Open-Label, Randomized Controlled Trial to Evaluate the Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec in Participants With Moderate COVID-19 Disease",TERMINATED,,PHASE2,1.0,ACTUAL,"Qurient Co., Ltd.",,2.0,,Sponsor's Decision,,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,INDUSTRY,,,,,,,2022,0.0
NCT04391179,,2020-05-15,2022-03-04,,2022-03-18,2020-05-15,2020-05-18,ACTUAL,2022-03-18,2022-03-24,ACTUAL,,,,2022-03-18,2022-03-24,ACTUAL,2020-05-31,ACTUAL,2020-05-31,2022-03,2022-03-31,2021-02-22,ACTUAL,2021-02-22,2021-02-22,ACTUAL,2021-02-22,,INTERVENTIONAL,DICER,,Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19,Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19,COMPLETED,,PHASE2,99.0,ACTUAL,University of Michigan,,2.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,OTHER,,,,,,,2021,1.0
NCT03019120,,2017-01-09,,,2020-02-24,2017-01-10,2017-01-12,ESTIMATED,,,,,,,2020-02-24,2020-02-26,ACTUAL,2017-01-15,ACTUAL,2017-01-15,2020-02,2020-02-29,2020-02-24,ACTUAL,2020-02-24,2020-02-24,ACTUAL,2020-02-24,,INTERVENTIONAL,Dcog,,Vitamin D Supplementation and Neurocognition,The Effect of Vitamin D Supplementation on Neurocognitive Function in Older Subjects,WITHDRAWN,,PHASE2,0.0,ACTUAL,Rambam Health Care Campus,,1.0,,"Due to administrative reasons, it was not possible to enroll subjects.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,OTHER,,,,,,,2020,0.0
NCT03880487,,2019-03-05,,,2021-09-09,2019-03-15,2019-03-19,ACTUAL,,,,,,,2021-09-09,2021-09-16,ACTUAL,2019-03-12,ACTUAL,2019-03-12,2021-02,2021-02-28,2020-04-21,ACTUAL,2020-04-21,2020-04-21,ACTUAL,2020-04-21,,INTERVENTIONAL,,,"A Single and Multiple Ascending Dose Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of KP-1199","A Randomized, Placebo- and Active-Controlled, Double-Blind, Single and Multiple Ascending Dose Study in Healthy Adults to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KP-1199",TERMINATED,,PHASE1,26.0,ACTUAL,"Kalyra Pharmaceuticals, Inc.",,3.0,,The Study was terminated early by sponsor,f,,,,t,t,f,,,,,,,,,,,2024-10-16 02:53:25.194058,2024-10-16 02:53:25.194058,INDUSTRY,,,,,,,2020,0.0
NCT05100628,,2021-10-20,,,2023-06-12,2021-10-20,2021-10-29,ACTUAL,,,,,,,2023-06-12,2023-06-15,ACTUAL,2022-02-11,ACTUAL,2022-02-11,2023-06,2023-06-30,2023-05-26,ACTUAL,2023-05-26,2023-05-01,ACTUAL,2023-05-01,,INTERVENTIONAL,,,"A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma","A Dose Escalation and Dose Expansion Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma - CEP-2",TERMINATED,,PHASE1,10.0,ACTUAL,Noxopharm Limited,,4.0,,Slow recruitment,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2023,0.0
NCT03067571,,2017-02-24,2023-08-22,,2023-09-18,2017-02-24,2017-03-01,ACTUAL,2023-09-18,2023-09-21,ACTUAL,,,,2023-09-18,2023-09-21,ACTUAL,2017-10-27,ACTUAL,2017-10-27,2023-09,2023-09-30,2022-11-21,ACTUAL,2022-11-21,2022-11-21,ACTUAL,2022-11-21,,INTERVENTIONAL,,,Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome,"An Open-Label, Phase 2 Trial Evaluating the Efficacy and Safety of Daratumumab in Subjects With Relapsed/Refractory Acute Myelogenous Leukemia or High-Risk Myelodysplastic Syndrome",TERMINATED,,PHASE2,7.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Study terminated early because of lack of efficacy,,,,,f,t,f,,,,,,,,,,,2024-10-16 02:53:25.194058,2024-10-16 02:53:25.194058,OTHER,,,,,,,2022,0.0
NCT00555399,,2007-11-06,2024-03-14,,2024-07-29,2007-11-06,2007-11-08,ESTIMATED,2024-07-29,2024-08-22,ACTUAL,,,,2024-07-29,2024-08-22,ACTUAL,2007-11-28,ACTUAL,2007-11-28,2024-07,2024-07-31,2020-01-24,ACTUAL,2020-01-24,2020-01-24,ACTUAL,2020-01-24,,INTERVENTIONAL,,Data provided for the demographics of participants enrolled into each arm is not related to the treatment cohorts but to the combination of agents used.,"Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM)","Phase I / II Adaptive Randomized Trial of Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme",TERMINATED,,PHASE1/PHASE2,55.0,ACTUAL,M.D. Anderson Cancer Center,,5.0,,No Sponsor funding for continuation of trial,f,,,,t,t,f,,,,,,,,,,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,OTHER,,,,,,,2020,0.0
NCT03510897,,2018-04-18,,,2021-07-12,2018-04-26,2018-04-27,ACTUAL,,,,,,,2021-07-12,2021-07-16,ACTUAL,2018-06-29,ACTUAL,2018-06-29,2021-07,2021-07-31,2021-04-12,ACTUAL,2021-04-12,2020-10-14,ACTUAL,2020-10-14,,INTERVENTIONAL,,,QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery,"A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery",TERMINATED,,PHASE3,1043.0,ACTUAL,Quark Pharmaceuticals,,2.0,,Study completed day 90 for primary endpoint but was terminated early for one year follow up due to results not meeting efficacy outcome at Day 90.,f,,,,t,t,f,,,,,,,,,,,2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,INDUSTRY,,,,,,,2021,0.0
NCT03442088,,2017-10-11,2022-09-26,,2022-12-22,2018-02-15,2018-02-22,ACTUAL,2022-12-22,2023-01-20,ACTUAL,,,,2022-12-22,2023-01-20,ACTUAL,2018-06-01,ACTUAL,2018-06-01,2022-12,2022-12-31,2021-09-30,ACTUAL,2021-09-30,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,,,Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast,An Investigator Initiated Study of Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast,COMPLETED,,PHASE2,28.0,ACTUAL,University Hospitals Cleveland Medical Center,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,OTHER,,,,,,,2021,1.0
NCT02855164,,2016-07-20,2021-04-06,,2021-08-11,2016-08-01,2016-08-04,ESTIMATED,2021-07-07,2021-07-29,ACTUAL,,,,2021-08-11,2021-09-05,ACTUAL,2016-08-01,ACTUAL,2016-08-01,2021-08,2021-08-31,2020-04-06,ACTUAL,2020-04-06,2020-04-06,ACTUAL,2020-04-06,,INTERVENTIONAL,FLIGHT-FXR,"Full analysis set (FAS) was all subjects to whom study treatment had been assigned. Following the intent-to-treat (ITT) principle, subjects were analyzed according to the treatment they have been assigned to at randomization.",Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH),"A Randomized, Double-blind, Placebo Controlled, 3- Part, Adaptive Design, Multicenter Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH): FLIGHT-FXR",TERMINATED,,PHASE2,350.0,ACTUAL,Novartis,No outputs were planned; and are not available for determining the effects of tropifexor on primary endpoints in the subset of patients who had historical biopsy data.,8.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,INDUSTRY,,,,,,,2020,0.0
NCT02215876,,2014-08-06,,,2016-04-13,2014-08-11,2014-08-13,ESTIMATED,,,,,,,2016-04-13,2016-04-15,ESTIMATED,2014-09,,2014-09-30,2016-04,2016-04-30,2020-03,ESTIMATED,2020-03-31,2017-08,ESTIMATED,2017-08-31,,INTERVENTIONAL,,,Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast Cancer,A Phase II (Single Center) Study of Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,No patients recruited.,f,,,,t,,,,,,,,,,,,,2024-10-16 02:53:25.194058,2024-10-16 02:53:25.194058,OTHER,,,,,,,2020,0.0
NCT04241068,,2020-01-22,,,2024-08-22,2020-01-22,2020-01-27,ACTUAL,,,,,,,2024-08-22,2024-08-23,ACTUAL,2020-03-02,ACTUAL,2020-03-02,2024-08,2024-08-31,2024-07-22,ACTUAL,2024-07-22,2024-07-22,ACTUAL,2024-07-22,,INTERVENTIONAL,,,"A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205","Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205",TERMINATED,,PHASE3,1696.0,ACTUAL,Biogen,,1.0,,Sponsor's Decision,f,,,,t,t,f,,,f,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2024,0.0
NCT05604287,,2022-10-28,,,2024-07-09,2022-10-28,2022-11-03,ACTUAL,,,,,,,2024-07-09,2024-07-11,ACTUAL,2022-10-10,ACTUAL,2022-10-10,2024-07,2024-07-31,2024-04-12,ACTUAL,2024-04-12,2024-04-12,ACTUAL,2024-04-12,,INTERVENTIONAL,,,"Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects","A Placebo-controlled, Randomized, Double-blind, Single and Multiple Dose-escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects in Healthy Participants",TERMINATED,,PHASE1,67.0,ACTUAL,IlDong Pharmaceutical Co Ltd,,4.0,,Sponsor have decided to cancel the trial,,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,INDUSTRY,,,,,,,2024,0.0
NCT03683719,,2018-09-21,2021-03-23,,2024-07-30,2018-09-21,2018-09-25,ACTUAL,2021-04-15,2021-04-19,ACTUAL,,,,2024-07-30,2024-08-22,ACTUAL,2018-11-28,ACTUAL,2018-11-28,2021-04,2021-04-30,2020-04-20,ACTUAL,2020-04-20,2020-03-06,ACTUAL,2020-03-06,,INTERVENTIONAL,,,"Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema","A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose-ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Application of Delgocitinib Cream 1, 3, 8, and 20 mg/g for 16 Weeks in Adult Subjects With Mild to Severe Chronic Hand Eczema",COMPLETED,,PHASE2,258.0,ACTUAL,LEO Pharma,,5.0,,,f,,,,f,t,f,,,,,,,De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.,https://www.leopharmatrials.com/for-researchers,YES,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2020,1.0
NCT03800784,,2019-01-09,,,2021-12-14,2019-01-09,2019-01-11,ACTUAL,,,,,,,2021-12-14,2021-12-15,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2021-12,2021-12-31,2021-10-21,ACTUAL,2021-10-21,2021-10-21,ACTUAL,2021-10-21,,INTERVENTIONAL,,,Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer,"Study of 18F-DCFPyL PET/CT, for Detection of Radiological Progression in Patients With Metastatic (M+) and Non-metastatic (M0) Castration Resistant Prostate Cancer Receiving Standard Androgen Receptor Targeted Treatment",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,Lack of funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:53:25.194058,2024-10-16 02:53:25.194058,OTHER,,,,,,,2021,0.0
NCT03869684,,2019-03-01,2021-02-24,,2021-03-24,2019-03-08,2019-03-11,ACTUAL,2021-03-24,2021-04-20,ACTUAL,,,,2021-03-24,2021-04-20,ACTUAL,2019-02-25,ACTUAL,2019-02-25,2021-03,2021-03-31,2020-04-24,ACTUAL,2020-04-24,2020-03-25,ACTUAL,2020-03-25,,INTERVENTIONAL,,,"A Study to Assess the Safety, Tolerability and Effectiveness of MT-0814 for the Treatment of Age-related Macular Degeneration","A Double-Masked, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of MT-0814 for the Treatment of Patients With Age-Related Macular Degeneration",TERMINATED,,PHASE2,13.0,ACTUAL,"Senju Pharmaceutical Co., Ltd.","All of the efficacy and safety measurements applied in this study are widely used and generally recognized as reliable, accurate, and relevant.",3.0,,The study terminated for safety reasons,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2020,0.0
NCT03739801,,2018-11-09,,,2020-03-25,2018-11-09,2018-11-14,ACTUAL,,,,,,,2020-03-25,2020-03-27,ACTUAL,2020-04-06,ESTIMATED,2020-04-06,2020-03,2020-03-31,2023-04-06,ESTIMATED,2023-04-06,2022-04-06,ESTIMATED,2022-04-06,,INTERVENTIONAL,,,MM-398 and Ramucirumab in Treating Patients With Gastric Cancer or Gastroesophageal Junction Adenocarcinoma,Phase I/II Study of MM-398 in Combination With Ramucirumab After Platinum Failure in Gastric Cancer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Southern California,,1.0,,PI left,f,,,,t,t,f,,,f,,,,,,,,2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,OTHER,,,,,,,2023,0.0
NCT02771860,,2016-03-18,2022-04-28,,2024-05-31,2016-05-10,2016-05-13,ESTIMATED,2024-05-31,2024-09-25,ACTUAL,,,,2024-05-31,2024-09-25,ACTUAL,2016-03,ACTUAL,2016-03-31,2024-05,2024-05-31,2021-04-28,ACTUAL,2021-04-28,2019-06-26,ACTUAL,2019-06-26,,INTERVENTIONAL,,,RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints,"Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Denosumab 60mg sc Every 3 Months in Patients With Erosive Osteoarthritis of the Interphalangeal (IP) Finger Joints",COMPLETED,,PHASE2,100.0,ACTUAL,"University Hospital, Ghent",,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,OTHER,,,,,,,2021,1.0
NCT04639310,,2020-11-04,2024-05-17,,2024-08-21,2020-11-19,2020-11-20,ACTUAL,2024-08-21,2024-08-23,ACTUAL,,,,2024-08-21,2024-08-23,ACTUAL,2021-03-29,ACTUAL,2021-03-29,2024-08,2024-08-31,2023-05-16,ACTUAL,2023-05-16,2023-05-16,ACTUAL,2023-05-16,,INTERVENTIONAL,EPIK,,XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy,A Phase 3 Study of Adjunctive XEN496 in Pediatric Subjects With KCNQ2 Developmental and Epileptic Encephalopathy,TERMINATED,,PHASE3,8.0,ACTUAL,Xenon Pharmaceuticals Inc.,,2.0,,Sponsor decision; Not a safety decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2023,0.0
NCT04656301,,2020-11-30,2023-02-14,,2023-02-14,2020-11-30,2020-12-07,ACTUAL,2023-02-14,2023-03-13,ACTUAL,,,,2023-02-14,2023-03-13,ACTUAL,2021-02-26,ACTUAL,2021-02-26,2023-02,2023-02-28,2022-11-02,ACTUAL,2022-11-02,2022-11-02,ACTUAL,2022-11-02,,INTERVENTIONAL,,,Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder,Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder,COMPLETED,,PHASE2,12.0,ACTUAL,New York State Psychiatric Institute,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,OTHER,,,,,,,2022,1.0
NCT03883945,,2019-03-16,,,2022-05-11,2019-03-19,2019-03-21,ACTUAL,,,,,,,2022-05-11,2022-05-17,ACTUAL,2021-07,ESTIMATED,2021-07-31,2022-05,2022-05-31,2022-08,ESTIMATED,2022-08-31,2022-07,ESTIMATED,2022-07-31,,INTERVENTIONAL,,,A Safety and Efficacy Study to Evaluate Rosacea,"A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Intradermally Administered AIV001 in Subjects With Papulopustular Rosacea",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"AiViva BioPharma, Inc.",,8.0,,Sponsor deprioritization,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 02:53:25.194058,2024-10-16 02:53:25.194058,INDUSTRY,,,,,,,2022,0.0
NCT03320174,,2017-10-18,,,2021-08-25,2017-10-24,2017-10-25,ACTUAL,,,,,,,2021-08-25,2021-08-26,ACTUAL,2017-10-05,ACTUAL,2017-10-05,2020-01,2020-01-31,2021-07-13,ACTUAL,2021-07-13,2021-07-13,ACTUAL,2021-07-13,,INTERVENTIONAL,,,Long-Term Safety Study of Tafenoquine,"Single Site, Randomized, Double Blind, Placebo-Controlled Study to Assess the Long-Term Safety of Tafenoquine",COMPLETED,,PHASE2,600.0,ACTUAL,60 Degrees Pharmaceuticals LLC,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,INDUSTRY,,,,,,,2021,0.0
NCT03344419,,2017-11-13,,,2024-07-12,2017-11-13,2017-11-17,ACTUAL,,,,,,,2024-07-12,2024-07-16,ACTUAL,2017-10-01,ACTUAL,2017-10-01,2024-07,2024-07-31,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders,Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders,SUSPENDED,,PHASE3,150.0,ESTIMATED,New York State Psychiatric Institute,,2.0,,Funding,f,,,,t,t,f,,,,,,,,,,,2024-10-16 02:53:25.194058,2024-10-16 02:53:25.194058,OTHER,,,,,,,2024,0.0
NCT04485663,,2020-07-09,,,2022-03-14,2020-07-21,2020-07-24,ACTUAL,,,,,,,2022-03-14,2022-03-15,ACTUAL,2020-08-17,ACTUAL,2020-08-17,2022-03,2022-03-31,2022-03-08,ACTUAL,2022-03-08,2022-03-08,ACTUAL,2022-03-08,,INTERVENTIONAL,,,"A Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects","A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study of Subcutaneously Administered ALG-010133 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Doses (Part 1) and Multiple Ascending Doses in Healthy Volunteers (Part 2), and Multiple Doses in Subjects With Chronic Hepatitis B (Part 3)",TERMINATED,,PHASE1,103.0,ACTUAL,Aligos Therapeutics,,2.0,,Lack of antiviral activity at the projected efficacious dose.,f,,,,,f,f,,,,,,,,,,,2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,INDUSTRY,,,,,,,2022,0.0
NCT05433402,,2022-06-22,,,2022-10-24,2022-06-22,2022-06-27,ACTUAL,,,,,,,2022-10-24,2022-10-27,ACTUAL,2022-07-20,ACTUAL,2022-07-20,2022-10,2022-10-31,2022-09-30,ACTUAL,2022-09-30,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,,,Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer,"Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer: A Pilot, Randomized, Open Label, Controlled Study.",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Sadat City University,,2.0,,Organizational safety isues,f,,,,t,f,f,,,,,,,,,YES,,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,OTHER,,,,,,,2022,0.0
NCT03435458,,2018-02-09,,,2023-05-11,2018-02-09,2018-02-19,ACTUAL,,,,,,,2023-05-11,2023-05-15,ACTUAL,2020-06-26,ACTUAL,2020-06-26,2023-05,2023-05-31,2023-02-02,ACTUAL,2023-02-02,2023-02-02,ACTUAL,2023-02-02,,INTERVENTIONAL,BIGW,,Balloon to Induce Labor in Generous Women.,Balloon to Induce Labor in Generous Women,TERMINATED,,PHASE3,429.0,ACTUAL,"University Hospital, Toulouse",,2.0,,interim analyses,f,,,,t,f,f,,,,,,,,,,,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,OTHER,,,,,,,2023,0.0
NCT04233697,,2020-01-15,,,2020-08-11,2020-01-15,2020-01-18,ACTUAL,,,,,,,2020-08-11,2020-08-13,ACTUAL,2020-02,ESTIMATED,2020-02-29,2020-08,2020-08-31,2023-07-30,ESTIMATED,2023-07-30,2022-07-30,ESTIMATED,2022-07-30,,INTERVENTIONAL,,,Copanlisib in Combination With Romidepsin in Patients With Relapsed or Refractory Mature T-cell Lymphoma,Phase 1B Study of the PI3K Inhibitor Copanlisib in Combination With Romidepsin in the Treatment of Patients With Relapsed or Refractory Mature T-cell Lymphoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,Columbia University,,1.0,,Investigator left institution,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:53:25.194058,2024-10-16 02:53:25.194058,OTHER,,,,,,,2023,0.0
NCT05036317,,2021-09-01,,,2024-08-13,2021-09-01,2021-09-05,ACTUAL,,,,,,,2024-08-13,2024-08-16,ACTUAL,2022-03-11,ACTUAL,2022-03-11,2024-08,2024-08-31,2024-08-05,ACTUAL,2024-08-05,2024-08-05,ACTUAL,2024-08-05,,INTERVENTIONAL,EmpHy,,Empagliflozin for the Treatment of Postprandial Hypoglycemia,Empagliflozin for the Treatment of Postprandial Hypoglycemia,TERMINATED,,PHASE3,40.0,ACTUAL,"University Hospital, Basel, Switzerland",,2.0,,Early terminated after prespecified interim analysis due to lack of efficacy. No relevant safety signals.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,OTHER,,,,,,,2024,0.0
NCT01746225,,2012-11-28,2018-08-24,,2023-05-30,2012-12-07,2012-12-10,ESTIMATED,2020-03-16,2020-03-27,ACTUAL,,,,2023-05-30,2023-06-01,ACTUAL,2013-04,,2013-04-30,2023-05,2023-05-31,2023-03-16,ACTUAL,2023-03-16,2016-05,ACTUAL,2016-05-31,,INTERVENTIONAL,SNAP,"Intention-to-treat population. Arm A had randomized 86 patient, but only 83 were analyzed. 3 patients excluded from analysis, who immediately withdrew consent or cancelled treatment.",Schedules of Nab-Paclitaxel in Metastatic Breast Cancer,A Randomized Phase II Study Evaluating Different Schedules of Nab-Paclitaxel in Metastatic Breast Cancer (SNAP Trial),COMPLETED,,PHASE2,258.0,ACTUAL,ETOP IBCSG Partners Foundation,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,NETWORK,,,,,,,2023,1.0
NCT02732015,,2016-04-04,2021-07-06,,2021-08-05,2016-04-04,2016-04-08,ESTIMATED,2021-08-05,2021-08-09,ACTUAL,,,,2021-08-05,2021-08-09,ACTUAL,2016-10-12,ACTUAL,2016-10-12,2021-08,2021-08-31,2020-07-10,ACTUAL,2020-07-10,2020-07-10,ACTUAL,2020-07-10,,INTERVENTIONAL,,,Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy,Effects of Rolapitant on Nausea/Vomiting in Patients With Sarcoma Receiving Multi-Day Highly Emetogenic Chemotherapy (HEC) With Doxorubicin and Ifosfamide Regimen (AI),TERMINATED,,PHASE2,37.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,Terminated per PI's request,f,,,,f,t,f,,,,,,,,,,,2024-10-17 00:30:03.82255,2024-10-17 00:30:03.82255,OTHER,,,,,,,2020,0.0
NCT02885727,,2016-08-19,,,2019-09-10,2016-08-26,2016-08-31,ESTIMATED,,,,,,,2019-09-10,2019-09-12,ACTUAL,2017-07,ESTIMATED,2017-07-31,2019-09,2019-09-30,2022-12,ESTIMATED,2022-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,Panc-Durval+RT,,Durvalumab Plus Booster RT for Metastatic Adenocarcinoma Pancreas Cancer Post Chemotherapy (GCC 1598),Phase II Trial of in Situ Tumor Vaccination Using Durvalumab and Booster Radiation Therapy in Patients With Metastatic Adenocarcinoma of the Pancreas Who Have Progressed Through First-line Chemotherapy,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of Maryland, Baltimore",,1.0,,Funding issues caused the study to not be opened the at local IRB,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,OTHER,,,,,,,2022,0.0
NCT03891979,,2019-03-25,,,2020-06-25,2019-03-25,2019-03-27,ACTUAL,,,,,,,2020-06-25,2020-06-26,ACTUAL,2019-06-25,ACTUAL,2019-06-25,2020-06,2020-06-30,2020-06-01,ACTUAL,2020-06-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,,,Gut Microbiome Modulation to Enable Efficacy of Checkpoint-based Immunotherapy in Pancreatic Adenocarcinoma,A Pilot Study of Gut Microbiome Modulation to Enable Efficacy of Checkpoint-based Immunotherapy in Pancreatic Adenocarcinoma,WITHDRAWN,,PHASE4,0.0,ACTUAL,NYU Langone Health,,1.0,,Suspended due to Primary Investigator's decision,,,,,f,t,f,,,,,,Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.,"Upon reasonable request. Requests should be directed to Kirsten.Swingle@nyulangone.org. To gain access, data requestors will need to sign a data access agreement",,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).",2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,OTHER,,,,,,,2020,0.0
NCT03993288,,2019-06-18,2021-06-18,,2021-06-18,2019-06-18,2019-06-20,ACTUAL,2021-06-18,2021-07-12,ACTUAL,,,,2021-06-18,2021-07-12,ACTUAL,2019-06-27,ACTUAL,2019-06-27,2021-06,2021-06-30,2020-06-18,ACTUAL,2020-06-18,2020-06-18,ACTUAL,2020-06-18,,INTERVENTIONAL,,,"Study to Test the Hypothesis of Non-inferior Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia), as Compared With MALTOFER® (Vifor S.A., Switzerland), in Subjects With Mild and Moderate Iron Deficiency Anemia.","Multicenter, Open-label Active-controlled Randomized Study of Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia) Compared With Maltofer® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Vifor S.A., Switzerland), in Treatment of Patients With Mild and Moderate Iron-deficiency Anaemia.",COMPLETED,,PHASE3,267.0,ACTUAL,Sandoz,,2.0,,,f,,,,f,f,f,,,,,,,This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,https://clinicalstudydatarequest.com/,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.",2024-10-16 12:16:45.870604,2024-10-16 12:16:45.870604,INDUSTRY,,,,,,,2020,1.0
NCT04978337,,2021-07-26,2023-03-30,,2024-08-29,2021-07-26,2021-07-27,ACTUAL,2023-03-30,2023-04-21,ACTUAL,,,,2024-08-29,2024-09-24,ACTUAL,2021-11-17,ACTUAL,2021-11-17,2024-08,2024-08-31,2022-03-31,ACTUAL,2022-03-31,2022-03-31,ACTUAL,2022-03-31,,INTERVENTIONAL,PRIMROSE,,A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection,"A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection Who Are at High Risk for RSV-related Disease Progression",TERMINATED,,PHASE2,5.0,ACTUAL,"Janssen Research & Development, LLC","As the study was terminated early, a low number of participants were enrolled, hence some efficacy analyses were not performed per change in the planned analysis. Thereby, data were analyzed for safety and selected efficacy parameters only.",2.0,,Janssen made the strategic decision to discontinue the PRIMROSE study. This decision is not based on any safety concerns.,t,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,INDUSTRY,,NCT04221412,NO_LONGER_AVAILABLE,,,,2022,0.0
NCT03620149,,2018-08-03,,,2021-01-04,2018-08-03,2018-08-08,ACTUAL,,,,,,,2021-01-04,2021-01-06,ACTUAL,2019-09-26,ACTUAL,2019-09-26,2021-01,2021-01-31,2020-07-30,ACTUAL,2020-07-30,2020-07-30,ACTUAL,2020-07-30,,INTERVENTIONAL,REDUCE,,Reduced Dose-density of Denosumab for Unresectable GCTB,Reduced Dose-density of Denosumab for Maintenance Therapy of Unresectable Giant Cell Tumor of Bone: a Multicenter Phase II Study REDUCE,TERMINATED,,PHASE2,2.0,ACTUAL,European Organisation for Research and Treatment of Cancer - EORTC,,1.0,,Poor accrual,f,,,,t,f,f,,,,,,,,,YES,All publications must comply with the terms specified in the EORTC Policy 009 Release of Results and Publication Policy.,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,NETWORK,,,,,,,2020,0.0
NCT04639024,,2020-11-05,,,2023-05-11,2020-11-19,2020-11-20,ACTUAL,,,,,,,2023-05-11,2023-05-12,ACTUAL,2021-12-07,ACTUAL,2021-12-07,2023-05,2023-05-31,2022-11-03,ACTUAL,2022-11-03,2022-11-03,ACTUAL,2022-11-03,,INTERVENTIONAL,,,"ADCT-301 in Patients With R/R AML, MDS, or MDS/MPN","An Open-label Pilot Study to Evaluate the Safety and Efficacy of ADCT-301 in Patients With Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Myeloproliferative Neoplasms.",TERMINATED,,PHASE2,3.0,ACTUAL,Duke University,,1.0,,ADCT is reallocating all resources to the phase III program.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,OTHER,,,,,,,2022,0.0
NCT04608331,,2020-10-21,,,2022-12-10,2020-10-27,2020-10-29,ACTUAL,,,,,,,2022-12-10,2022-12-13,ACTUAL,2021-01-29,ACTUAL,2021-01-29,2022-12,2022-12-31,2022-09-20,ACTUAL,2022-09-20,2022-08-17,ACTUAL,2022-08-17,,INTERVENTIONAL,,,Dexmedetomidine Supplemented Analgesia in Patients at High-risk of Obstructive Sleep Apnea,"Impact of Dexmedetomidine Supplemented Analgesia on Sleep Quality in Patients at High-risk of Obstructive Sleep Apnea After Major Surgery: A Randomized, Double-blind, and Placebo-controlled Pilot Study",COMPLETED,,PHASE4,152.0,ACTUAL,Peking University First Hospital,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,OTHER,,,,,,,2022,1.0
NCT04633772,,2020-11-06,,,2021-11-08,2020-11-17,2020-11-18,ACTUAL,,,,,,,2021-11-08,2021-11-09,ACTUAL,2020-08-05,ACTUAL,2020-08-05,2021-11,2021-11-30,2021-11-01,ACTUAL,2021-11-01,2021-11-01,ACTUAL,2021-11-01,,INTERVENTIONAL,,,Use of Angiotensin-(1-7) in COVID-19,Randomized Clinical Trial Phase I/II for the Use of Angiotensin-(1-7) in the Treatment of Severe Infection by Sars-CoV-2,COMPLETED,,PHASE1/PHASE2,112.0,ACTUAL,Erasme University Hospital,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,OTHER,,,,,,,2021,0.0
NCT03349775,,2017-06-06,2021-12-21,,2021-12-21,2017-11-20,2017-11-22,ACTUAL,2021-12-21,2022-01-21,ACTUAL,,,,2021-12-21,2022-01-21,ACTUAL,2017-11-27,ACTUAL,2017-11-27,2021-12,2021-12-31,2020-12-22,ACTUAL,2020-12-22,2020-12-22,ACTUAL,2020-12-22,,INTERVENTIONAL,,Baseline population includes participants who completed the assigned arm (metformin or placebo) and were included in analysis.,Cardiometabolic Disease and Pulmonary Hypertension,Cardiometabolic Disease and Pulmonary Hypertension,TERMINATED,,EARLY_PHASE1,21.0,ACTUAL,Massachusetts General Hospital,"After discussion with the Data Safety Monitoring Board and NIH, the randomized clinical trial involving metformin vs. placebo was terminated due to slow enrollment in the setting of the COVID-19 pandemic, resulting in small numbers of subjects analyzed.",2.0,,"After discussion with the Data Safety Monitoring Board and NIH, the randomized clinical trial involving metformin vs. placebo is terminated due to slow enrollment in the setting of the COVID-19 pandemic.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:53:25.194058,2024-10-16 02:53:25.194058,OTHER,,,,,,,2020,0.0
NCT01720524,,2012-09-17,2019-10-16,,2021-08-12,2012-10-31,2012-11-02,ESTIMATED,2020-03-24,2020-03-25,ACTUAL,,,,2021-08-12,2021-08-16,ACTUAL,2013-08-05,ACTUAL,2013-08-05,2021-08,2021-08-31,2020-09-28,ACTUAL,2020-09-28,2018-10-17,ACTUAL,2018-10-17,,INTERVENTIONAL,,Safety population included all participants treated with study treatment.,A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn,"A MULTI-CENTRE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, TWO-ARMED, PARALLEL GROUP STUDY TO EVALUATE EFFICACY AND SAFETY OF IV SILDENAFIL IN THE TREATMENT OF NEONATES WITH PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN) OR HYPOXIC RESPIRATORY FAILURE AND AT RISK FOR PPHN, WITH A LONG TERM FOLLOW-UP INVESTIGATION OF DEVELOPMENTAL PROGRESS 12 AND 24 MONTHS AFTER COMPLETION OF STUDY TREATMENT",COMPLETED,,PHASE3,59.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,INDUSTRY,,,,,,,2020,1.0
NCT04091737,,2019-09-13,,,2021-06-14,2019-09-13,2019-09-17,ACTUAL,,,,,,,2021-06-14,2021-06-18,ACTUAL,2019-10-02,ACTUAL,2019-10-02,2021-06,2021-06-30,2021-05-05,ACTUAL,2021-05-05,2021-05-05,ACTUAL,2021-05-05,,INTERVENTIONAL,,,CSL200 Gene Therapy in Adults With Severe Sickle Cell Disease,A Phase 1 Pilot Study to Evaluate the Safety and Feasibility of Gene Therapy With CSL200 (Autologous Enriched CD34+ Cell Fraction That Contains CD34+ Cells Transduced With Lentiviral Vector Encoding Human γ-GlobinG16D and Short-Hairpin RNA734) in Adult Subjects With Severe Sickle Cell Disease,TERMINATED,,PHASE1,1.0,ACTUAL,CSL Behring,,1.0,,"Unanticipated delays, not for safety reasons",f,,,,t,t,f,,,,,,IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.,Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.~An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.~The requesting party must execute an appropriate data sharing agreement before IPD will be made available.,,YES,"CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.~Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.~If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.",2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,INDUSTRY,,,,,,,2021,0.0
NCT02144077,,2014-02-20,2017-10-26,,2022-10-11,2014-05-19,2014-05-21,ESTIMATED,2018-11-15,2019-03-11,ACTUAL,,,,2022-10-11,2022-11-03,ACTUAL,2014-01-28,ACTUAL,2014-01-28,2022-10,2022-10-31,2020-09-09,ACTUAL,2020-09-09,2015-11-17,ACTUAL,2015-11-17,,INTERVENTIONAL,,,Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy,"A Randomized, Observer Blind, Multinational Phase III Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) in Comparison to Metvix® in the Treatment of Non-aggressive Basal Cell Carcinoma (BCC) With Photodynamic Therapy (PDT)",COMPLETED,,PHASE3,281.0,ACTUAL,Biofrontera Bioscience GmbH,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,INDUSTRY,,,,,,,2020,1.0
NCT03725267,,2018-10-11,,,2021-08-24,2018-10-27,2018-10-31,ACTUAL,,,,,,,2021-08-24,2021-08-27,ACTUAL,2018-10-01,ACTUAL,2018-10-01,2021-08,2021-08-31,2021-07-01,ACTUAL,2021-07-01,2021-06-15,ACTUAL,2021-06-15,,INTERVENTIONAL,,,Melatonin for Renal Protection in Patients Receiving Polymyxin B,Melatonin for Renal Protection in Patients Receiving Polymyxin B:a Randomized Clinical Trial,TERMINATED,,PHASE2,88.0,ACTUAL,Hospital de Clinicas de Porto Alegre,,2.0,,"Due to COVID 19 pandemic social isolation measures, we had to stop recruting hospitalized patients.",f,,,,f,f,f,,,,,,,,,UNDECIDED,We will provide individual participant data if required by direct contact with our PI.,2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,OTHER,,,,,,,2021,0.0
NCT04387461,,2020-05-05,,,2024-09-23,2020-05-12,2020-05-13,ACTUAL,,,,,,,2024-09-23,2024-09-25,ACTUAL,2020-12-08,ACTUAL,2020-12-08,2024-09,2024-09-30,2024-05-28,ACTUAL,2024-05-28,2023-03-07,ACTUAL,2023-03-07,,INTERVENTIONAL,CORE-001,,"Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin","A Phase 2, Single Arm Study of CG0070 Combined With Pembrolizumab in Patients With Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)",COMPLETED,,PHASE2,35.0,ACTUAL,"CG Oncology, Inc.",,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,INDUSTRY,,,,,,,2024,1.0
NCT03150420,,2017-03-29,,,2020-05-15,2017-05-11,2017-05-12,ACTUAL,,,,,,,2020-05-15,2020-05-19,ACTUAL,2017-05-24,ACTUAL,2017-05-24,2020-05,2020-05-31,2020-04-15,ACTUAL,2020-04-15,2020-04-15,ACTUAL,2020-04-15,,INTERVENTIONAL,CALISTA,,A Phase 3 Clinical Trial of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients,"A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Trial",TERMINATED,,PHASE3,29.0,ACTUAL,Hope Pharmaceuticals,,2.0,,Inability to accrue subjects that met the exclusion criterion Any prior (within the past 30 days) or current Sodium Thiosulfate treatment.,,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,INDUSTRY,,,,,,,2020,0.0
NCT03044249,,2017-01-31,2021-01-29,,2021-03-05,2017-02-02,2017-02-06,ESTIMATED,2021-03-05,2021-04-01,ACTUAL,,,,2021-03-05,2021-04-01,ACTUAL,2017-05-04,ACTUAL,2017-05-04,2021-03,2021-03-31,2020-01-30,ACTUAL,2020-01-30,2020-01-30,ACTUAL,2020-01-30,,INTERVENTIONAL,,All randomized participants who received at least one dose of study drug.,A Study of MP-101 in Dementia-Related Psychosis and/or Agitation and Aggression,"Tolerability, Pharmacokinetics, and Efficacy of MP-101 in the Treatment of Patients With Dementia-Related Psychosis and/or Agitation and Aggression",TERMINATED,,PHASE2,81.0,ACTUAL,Mediti Pharma Inc.,Statistical futility; totality of evidence suggests study unlikely to meet endpoint.,2.0,,Statistical futility; totality of evidence suggests study unlikely to meet endpoint,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 02:53:25.194058,2024-10-16 02:53:25.194058,OTHER,,,,,,,2020,0.0
NCT02991651,,2016-12-07,,,2024-04-02,2016-12-09,2016-12-13,ESTIMATED,,,,,,,2024-04-02,2024-04-03,ACTUAL,2016-05,,2016-05-31,2024-03,2024-03-31,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Study of IRX4204 With Erlotinib in Previously Treated Advanced NSCLC,A Phase I Study of IRX4204 in Combination With Erlotinib in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer,SUSPENDED,,PHASE1,12.0,ESTIMATED,Io Therapeutics,,3.0,,Limited IRX4204 Study Drug Supply,f,,,,f,,,,,,,,,,,NO,,2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,INDUSTRY,,,,,,,2024,0.0
NCT03857139,,2019-02-26,,,2022-05-16,2019-02-26,2019-02-27,ACTUAL,,,,,,,2022-05-16,2022-05-20,ACTUAL,2020-12,ESTIMATED,2020-12-31,2022-05,2022-05-31,2023-01,ESTIMATED,2023-01-31,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,,,Opioids and Smoking Cessation,The Impact of Opioid Misuse on Tobacco Smoking Cessation,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Houston,,1.0,,Grant funding not obtained,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,OTHER,,,,,,,2023,0.0
NCT04292223,,2020-02-28,,,2022-08-31,2020-02-28,2020-03-03,ACTUAL,,,,,,,2022-08-31,2022-09-01,ACTUAL,2020-02-10,ACTUAL,2020-02-10,2022-08,2022-08-31,2022-04-26,ACTUAL,2022-04-26,2022-04-26,ACTUAL,2022-04-26,,INTERVENTIONAL,,,Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis,A 16-Week Open-Label Study of the Effects of Treatment With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis,COMPLETED,,PHASE4,29.0,ACTUAL,ACADIA Pharmaceuticals Inc.,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,INDUSTRY,,,,,,,2022,1.0
NCT03926728,,2019-04-15,2023-08-02,,2024-03-25,2019-04-23,2019-04-24,ACTUAL,2024-03-25,2024-08-22,ACTUAL,,,,2024-03-25,2024-08-22,ACTUAL,2020-02-17,ACTUAL,2020-02-17,2024-03,2024-03-31,2022-02-22,ACTUAL,2022-02-22,2022-02-22,ACTUAL,2022-02-22,,INTERVENTIONAL,CHLM-02,,Safety and Immunogenicity of a Chlamydia Vaccine CTH522,"A Phase I, Double-blind, Parallel, Randomised and Placebo-controlled Trial Investigating the Safety and Immunogenicity of a Chlamydia Vaccine, CTH522, in Healthy Adults",COMPLETED,,PHASE1,65.0,ACTUAL,Statens Serum Institut,Screening and recruitment activities had to be paused during the trial due to the Covid-19 pandemic.,6.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,OTHER,,,,,,,2022,1.0
NCT04221061,,2020-01-06,,,2024-06-13,2020-01-06,2020-01-09,ACTUAL,,,,,,,2024-06-13,2024-06-17,ACTUAL,2020-02-20,ACTUAL,2020-02-20,2024-06,2024-06-30,2024-06-10,ACTUAL,2024-06-10,2024-06-10,ACTUAL,2024-06-10,,INTERVENTIONAL,,,18F-FluorThanatrace (PET/CT) in Glioblastoma,A Pilot Study Evaluating in Vivo PARP-1 Expression with18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Glioblastoma,TERMINATED,,EARLY_PHASE1,3.0,ACTUAL,University of Pennsylvania,,2.0,,Companion treatment trial closed early with negative results. No imaging study participants completed the full study imaging planned due to logistical difficulties.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,OTHER,,,,,,,2024,0.0
NCT03944512,,2019-05-07,,,2024-07-08,2019-05-08,2019-05-09,ACTUAL,,,,,,,2024-07-08,2024-07-09,ACTUAL,2019-07-17,ACTUAL,2019-07-17,2024-07,2024-07-31,2024-06-20,ACTUAL,2024-06-20,2021-06-06,ACTUAL,2021-06-06,,INTERVENTIONAL,Pravastatin,,Pravastatin to Prevent Preeclampsia,A Randomized Controlled Trial of Pravastatin to Prevent Preeclampsia in High Risk Women,TERMINATED,,PHASE3,50.0,ACTUAL,The George Washington University Biostatistics Center,,2.0,,participants are no longer being examined or receiving intervention,f,,,,t,t,f,,,,,,,,,YES,The dataset will be shared per NIH policy after the completion and publication of the main analyses. The limited access data set will be submitted to NICHD (Data and Specimen Hub - DASH) and NHLBI (Biologic Specimen and Data Repository Information Coordinating Center - BioLINCC).,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,OTHER,,,,,,,2024,0.0
NCT03694834,,2018-10-01,,,2023-11-22,2018-10-01,2018-10-03,ACTUAL,,,,,,,2023-11-22,2023-11-28,ACTUAL,2019-03-29,ACTUAL,2019-03-29,2023-11,2023-11-30,2023-10-23,ACTUAL,2023-10-23,2023-10-23,ACTUAL,2023-10-23,,INTERVENTIONAL,,,Window of Opportunity Pilot Study of Pembrolizumab in Obesity-driven Endometrial Cancer,Window of Opportunity Pilot Study of Pembrolizumab in Obesity-driven Endometrial Cancer,TERMINATED,,EARLY_PHASE1,3.0,ACTUAL,UNC Lineberger Comprehensive Cancer Center,,1.0,,Slow accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,OTHER,,,,,,,2023,0.0
NCT04001803,,2019-06-10,2021-09-29,,2023-03-16,2019-06-26,2019-06-28,ACTUAL,2021-12-10,2022-01-10,ACTUAL,,,,2023-03-16,2023-04-14,ACTUAL,2019-07-08,ACTUAL,2019-07-08,2023-03,2023-03-31,2022-03-18,ACTUAL,2022-03-18,2020-10-05,ACTUAL,2020-10-05,,INTERVENTIONAL,,"Baseline characteristics were reported for Safety Population(comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA).Study staff participants only provided input through completion of surveys,semi-structured interviews,facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Demographics for study staff participants were not collected because it was not required per study design",Study to Identify and Determine Best Implementation Practices for Injectable Cabotegravir+Rilpivirine in the United States (US),A Qualitative Hybrid III Implementation Study to Identify and Evaluate Strategies for Successful Implementation of the Cabotegravir + Rilpivirine Long-acting Injectable Regimen in the US,COMPLETED,,PHASE3,115.0,ACTUAL,ViiV Healthcare,,1.0,,,f,,,,f,t,f,,,,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/,YES,Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,INDUSTRY,,,,,,,2022,1.0
NCT01449461,,2011-09-30,2017-05-26,,2021-07-26,2011-10-06,2011-10-10,ESTIMATED,2017-05-26,2017-06-21,ACTUAL,,,,2021-07-26,2021-08-17,ACTUAL,2011-09-20,ACTUAL,2011-09-20,2021-07,2021-07-31,2020-02-18,ACTUAL,2020-02-18,2015-11-16,ACTUAL,2015-11-16,,INTERVENTIONAL,,Safety population included all enrolled participants who received at least one dose of study drug.,"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral Anaplastic Lymphoma Kinase (ALK)/Epidermal Growth Factor Receptor (EGFR) Inhibitor Brigatinib (AP26113)","A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral ALK/EGFR Inhibitor AP26113",COMPLETED,,PHASE1/PHASE2,137.0,ACTUAL,Takeda,,6.0,,,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 02:53:25.194058,2024-10-16 02:53:25.194058,INDUSTRY,,,,,,,2020,1.0
NCT03228940,,2017-07-18,,,2023-11-14,2017-07-20,2017-07-25,ACTUAL,,,,,,,2023-11-14,2023-11-18,ACTUAL,2022-11-22,ESTIMATED,2022-11-22,2023-11,2023-11-30,2022-11-22,ACTUAL,2022-11-22,2022-11-22,ACTUAL,2022-11-22,,INTERVENTIONAL,,,Safety and Effect of Oral RVX000222 in Subjects With Fabry Disease,An Open-Label Study to Assess the Safety and Effect on Key Biomarkers of Oral RVX000222 in Subjects With Fabry Disease,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Resverlogix Corp,,1.0,,Changed development priorities,f,,,,,t,f,,,t,,,,,,UNDECIDED,,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,INDUSTRY,,,,,,,2022,0.0
NCT02499120,,2015-07-13,2019-06-23,,2023-08-14,2015-07-13,2015-07-15,ESTIMATED,2019-09-18,2019-09-20,ACTUAL,,,,2023-08-14,2023-09-08,ACTUAL,2015-09-10,ACTUAL,2015-09-10,2023-08,2023-08-31,2022-09-07,ACTUAL,2022-09-07,2018-07-19,ACTUAL,2018-07-19,,INTERVENTIONAL,,Baseline analysis population included all participants who were randomized.,Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer,"A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 2 STUDY OF PALBOCICLIB PLUS CETUXIMAB VERSUS CETUXIMAB FOR THE TREATMENT OF HUMAN PAPILLOMAVIRUS-NEGATIVE, CETUXIMAB-NAÏVE PATIENTS WITH RECURRENT/METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK AFTER FAILURE OF ONE PRIOR PLATINUM-CONTAINING CHEMOTHERAPY REGIMEN",COMPLETED,,PHASE2,125.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,INDUSTRY,,,,,,,2022,1.0
NCT02591030,,2015-10-26,,,2022-02-23,2015-10-28,2015-10-29,ESTIMATED,,,,,,,2022-02-23,2022-02-24,ACTUAL,2015-12-15,ACTUAL,2015-12-15,2022-02,2022-02-28,2020-01-16,ACTUAL,2020-01-16,2018-06-27,ACTUAL,2018-06-27,,INTERVENTIONAL,AMEBICA,,Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours,"Randomised Phase II/III Study, Assessing the Safety and Efficacy of Modified Folfirinox Versus Gemcis in Locally Advanced, Unresectable and/or Metastatic Bile Duct Tumours",COMPLETED,,PHASE2/PHASE3,191.0,ACTUAL,Centre Hospitalier Universitaire de Saint Etienne,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,OTHER,,,,,,,2020,0.0
NCT04442178,,2020-06-19,,,2022-03-30,2020-06-19,2020-06-22,ACTUAL,,,,,,,2022-03-30,2022-04-08,ACTUAL,2020-09-15,ACTUAL,2020-09-15,2022-03,2022-03-31,2022-03-30,ACTUAL,2022-03-30,2022-03-30,ACTUAL,2022-03-30,,INTERVENTIONAL,ILIAD-7-US-I,,InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection ( ILIAD-7-US-I ),"A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection. US Infectious Cohort",TERMINATED,,PHASE2,26.0,ACTUAL,Revimmune,,2.0,,POOR ACCRUAL,f,,,,t,t,f,,,,,,,,,NO,Publication,2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,INDUSTRY,,,,,,,2022,0.0
NCT04798027,,2021-03-11,2023-09-29,2023-06-21,2023-12-13,2021-03-12,2021-03-15,ACTUAL,2023-12-13,2023-12-15,ACTUAL,,2023-12-15,ACTUAL,2023-12-13,2023-12-15,ACTUAL,2021-03-12,ACTUAL,2021-03-12,2023-12,2023-12-31,2022-06-27,ACTUAL,2022-06-27,2022-06-27,ACTUAL,2022-06-27,,INTERVENTIONAL,VAW00001,Analysis was performed on all enrolled participants according to the intervention to which they were randomized. Data for baseline characteristics was planned to be collected and analyzed for combined population (Full Enrollment Cohort + Sentinel Cohort) in which the same dose-level groups in Sentinel Cohort and Full Enrollment Cohort were pooled for the analysis. Since Sentinel Cohort: SARS-CoV-2 Vaccine Medium Dose group received 2 injections; they were presented under Cohort 2 for analysis.,Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older,Immunogenicity and Safety of the First-in-Human SARS-CoV-2 mRNA Vaccine Formulation in Healthy Adults 18 Years of Age and Older,TERMINATED,,PHASE1/PHASE2,182.0,ACTUAL,Sanofi,"Due to early termination of this study by the Sponsor prior to full enrollment, the corresponding testing was not conducted, and few planned efficacy outcome measures data were not collected and analysis was not performed.",9.0,,Sponsor's decision not to pursue further development of this product given the wide availability of authorized/approved mRNA COVID-19 vaccines,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,INDUSTRY,,,,,,,2022,0.0
NCT02450773,,2015-05-11,,,2023-05-09,2015-05-18,2015-05-21,ESTIMATED,,,,,,,2023-05-09,2023-05-11,ACTUAL,2015-08,,2015-08-31,2023-05,2023-05-31,2022-05,ESTIMATED,2022-05-31,2022-05,ESTIMATED,2022-05-31,,INTERVENTIONAL,,,Prevention of Severe Postpartum Hypertension,Furosemide for Prevention of Severe Postpartum Hypertension: a Randomized Controlled Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,Indiana University,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,OTHER,,,,,,,2022,0.0
NCT02531724,,2015-08-20,,,2021-03-17,2015-08-20,2015-08-24,ESTIMATED,,,,,,,2021-03-17,2021-03-18,ACTUAL,2015-09,ACTUAL,2015-09-30,2021-03,2021-03-31,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,LEVOAKI,,Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery,Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery,COMPLETED,,PHASE4,30.0,ACTUAL,"Sahlgrenska University Hospital, Sweden",,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,OTHER,,,,,,,2020,1.0
NCT02797977,,2016-05-23,,,2023-06-20,2016-06-13,2016-06-14,ESTIMATED,,,,,,,2023-06-20,2023-06-22,ACTUAL,2016-07,ACTUAL,2016-07-31,2022-06,2022-06-30,2020-04-08,ACTUAL,2020-04-08,2020-04-08,ACTUAL,2020-04-08,,INTERVENTIONAL,,,A Phase 1/2 Trial SRA737 in Combination With Gemcitabine and Cisplatin or Gemcitabine Alone in Advanced Cancer Subjects,A Phase 1/2 Trial of Oral SRA737 (a Chk1 Inhibitor) Given in Combination With Gemcitabine Plus Cisplatin or Gemcitabine Alone in Subjects With Advanced Cancer,COMPLETED,,PHASE1/PHASE2,153.0,ACTUAL,Sierra Oncology LLC - a GSK company,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,INDUSTRY,,,,,,,2020,1.0
NCT04345289,,2020-04-10,,,2022-08-02,2020-04-10,2020-04-14,ACTUAL,,,,,,,2022-08-02,2022-08-04,ACTUAL,2020-05-01,ACTUAL,2020-05-01,2022-08,2022-08-31,2021-03-16,ACTUAL,2021-03-16,2021-03-16,ACTUAL,2021-03-16,,INTERVENTIONAL,CCAP,,Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia,"Efficacy and Safety of Treatment With Convalescent Plasma for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multicenter Placebo-controlled Trial",TERMINATED,,PHASE3,147.0,ACTUAL,Hvidovre University Hospital,,2.0,,DSMB advise due to high probability of futility,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 02:53:25.194058,2024-10-16 02:53:25.194058,OTHER,,,,,,,2021,0.0
NCT03451123,,2018-02-23,,,2023-12-12,2018-02-23,2018-03-01,ACTUAL,,,,,,,2023-12-12,2023-12-19,ACTUAL,2018-04-23,ACTUAL,2018-04-23,2023-12,2023-12-31,2023-08-29,ACTUAL,2023-08-29,2023-08-29,ACTUAL,2023-08-29,,INTERVENTIONAL,,,FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors,FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors,TERMINATED,,EARLY_PHASE1,1.0,ACTUAL,University of Alabama at Birmingham,,1.0,,Insufficient recruitment,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,OTHER,,,,,,,2023,0.0
NCT05355077,,2022-04-20,,,2023-02-07,2022-04-25,2022-05-02,ACTUAL,,,,,,,2023-02-07,2023-02-09,ACTUAL,2022-05-02,ESTIMATED,2022-05-02,2022-04,2022-04-30,2022-10-24,ESTIMATED,2022-10-24,2022-08-01,ESTIMATED,2022-08-01,,INTERVENTIONAL,,,"Evaluate the Pharmacokinetics, Safety and Tolerability of JT001 Tablets","An Open-label, Dose-Escalation, Multiple-Dose Phase 1 Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of JT001 Tablets in Caucasian Healthy Subjects After Oral Administrations",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Shanghai Vinnerna Biosciences Co., Ltd.",,3.0,,Development strategy adjustment,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,INDUSTRY,,,,,,,2022,0.0
NCT04249336,,2019-09-26,2021-01-17,,2021-04-19,2020-01-29,2020-01-30,ACTUAL,2021-04-19,2021-05-11,ACTUAL,,,,2021-04-19,2021-05-11,ACTUAL,2019-09-27,ACTUAL,2019-09-27,2021-04,2021-04-30,2021-01-16,ACTUAL,2021-01-16,2021-01-16,ACTUAL,2021-01-16,,INTERVENTIONAL,,"35 individuals per treatment group were recruited and enrolled in the study after clinical diagnosis of dentin hypersensitivity using air blast stimulus and SCHIFF cold air sensitivity scale. These participants were tested again for dentin hypersensitivity using mechanical stimulus and Visual Analogue Scale. After lost to follow up, statistical analysis was performed for 32 participants per group with baseline SCHIFF scale score of ≥2 and visual Analogue Scale score of ≥4.","Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH","Immediate And Sustained Treatment Response Of Commercially Available BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In Dentin Hypersensitivity - A Randomized Clinical Trial",COMPLETED,,PHASE3,140.0,ACTUAL,Dow University of Health Sciences,,4.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,OTHER,,,,,,,2021,1.0
NCT00585559,,2007-12-26,,,2023-12-29,2007-12-26,2008-01-03,ESTIMATED,,,,,,,2023-12-29,2024-01-03,ACTUAL,2007-04,,2007-04-30,2023-12,2023-12-31,2023-10-26,ACTUAL,2023-10-26,2023-10-26,ACTUAL,2023-10-26,,INTERVENTIONAL,,,Acetaminophen in aSAH to Inhibit Lipid Peroxidation and Cerebral Vasospasm,Inhibition of Lipid Peroxidation and Cerebral Vasospasm by an Acetaminophen-Based Regimen in Patients With Aneurysmal Subarachnoid Hemorrhage,TERMINATED,,PHASE3,120.0,ESTIMATED,Vanderbilt University Medical Center,,5.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,OTHER,,,,,,,2023,0.0
NCT03911076,,2019-04-05,,,2024-06-13,2019-04-09,2019-04-10,ACTUAL,,,,,,,2024-06-13,2024-06-17,ACTUAL,2019-05-22,ACTUAL,2019-05-22,2024-06,2024-06-30,2022-06-08,ACTUAL,2022-06-08,2022-06-08,ACTUAL,2022-06-08,,INTERVENTIONAL,PVX2,,"Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL","A Randomized Double-Blind, Placebo-controlled Phase II Trial With Safety Run-In of Intramuscular pNGVL4a-Sig/E7(Detox)/HSP70 and TA-CIN for the Treatment of Patients With HPV16+ Atypical Squamous Cells of Undetermined Significance (ASC-US) or Cannot Exclude High Grade SIL (ASC-H) Cytology or Low-grade Squamous Intraepithelial Lesion (LSIL)",TERMINATED,,PHASE2,16.0,ACTUAL,"PapiVax Biotech, Inc.",,2.0,,Slow recruitment/funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,OTHER,,,,,,,2022,0.0
NCT02065570,,2014-02-17,2021-01-20,,2021-02-11,2014-02-17,2014-02-19,ESTIMATED,2021-02-11,2021-02-18,ACTUAL,,,,2021-02-11,2021-02-18,ACTUAL,2014-05-01,ACTUAL,2014-05-01,2021-02,2021-02-28,2020-01-30,ACTUAL,2020-01-30,2020-01-30,ACTUAL,2020-01-30,,INTERVENTIONAL,,,Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease,"A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration",COMPLETED,,PHASE3,514.0,ACTUAL,AbbVie,,4.0,,,f,,,,f,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,INDUSTRY,,,,,,,2020,1.0
NCT04831502,,2021-04-01,,,2022-03-22,2021-04-01,2021-04-05,ACTUAL,,,,,,,2022-03-22,2022-03-24,ACTUAL,2021-04-02,ACTUAL,2021-04-02,2022-03,2022-03-31,2022-02-02,ACTUAL,2022-02-02,2022-02-02,ACTUAL,2022-02-02,,INTERVENTIONAL,,,Bioavailability and Food Effect Study of Two Formulations of TAK-906,"A Phase 1, Open Label, Randomized, Single-Dose, Replicate Crossover Study to Determine the Bioavailability of the Tablet Formulation Relative to the Capsule Formulation of TAK-906 and the Effect of Food on the Pharmacokinetics of the Tablet Formulation in Healthy Subjects",WITHDRAWN,,PHASE1,0.0,ACTUAL,Takeda,,2.0,,Business decision,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,INDUSTRY,,,,,,,2022,0.0
NCT04399889,,2020-05-21,2022-10-24,,2022-11-29,2020-05-21,2020-05-22,ACTUAL,2022-11-29,2022-12-20,ACTUAL,,,,2022-11-29,2022-12-20,ACTUAL,2020-06-18,ACTUAL,2020-06-18,2022-11,2022-11-30,2022-02-16,ACTUAL,2022-02-16,2022-02-16,ACTUAL,2022-02-16,,INTERVENTIONAL,,,hCT-MSCs for COVID19 ARDS,Pilot Study of Safety and Efficacy of Cord Tissue Derived Mesenchymal Stromal Cells (hCT-MSC) in COVID-19 Related Acute Respiratory Distress Syndrome (ARDS),TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,Duke University,,3.0,,low accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,OTHER,,,,,,,2022,0.0
NCT04770389,,2021-02-22,2024-03-27,,2024-03-27,2021-02-22,2021-02-25,ACTUAL,2024-03-27,2024-04-24,ACTUAL,,,,2024-03-27,2024-04-24,ACTUAL,2021-02-23,ACTUAL,2021-02-23,2024-03,2024-03-31,2021-06-30,ACTUAL,2021-06-30,2021-05-07,ACTUAL,2021-05-07,,INTERVENTIONAL,OCEAN,The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.,Randomized Study of Obicetrapib in Combination With Ezetimibe,"A Placebo-Controlled, Double-Blind, Randomized Phase 2 Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe in Participants With Mild Dyslipidemia",COMPLETED,,PHASE2,112.0,ACTUAL,NewAmsterdam Pharma,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,INDUSTRY,,,,,,,2021,1.0
NCT03677830,,2018-09-06,,,2024-03-11,2018-09-17,2018-09-19,ACTUAL,,,,,,,2024-03-11,2024-03-13,ACTUAL,2019-04-19,ACTUAL,2019-04-19,2024-03,2024-03-31,2024-03-07,ACTUAL,2024-03-07,2024-03-07,ACTUAL,2024-03-07,,INTERVENTIONAL,POPCORN,,Postoperative Pain Control & Relief in Neonates,Postoperative Pain Control & Relief in Neonates,TERMINATED,,PHASE4,11.0,ACTUAL,St. Louis University,,2.0,,Involved investigators no longer at the investigating center,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,OTHER,,,,,,,2024,0.0
NCT04058028,,2019-07-30,2024-07-17,,2024-08-28,2019-08-13,2019-08-15,ACTUAL,2024-08-28,2024-09-24,ACTUAL,,,,2024-08-28,2024-09-24,ACTUAL,2020-02-19,ACTUAL,2020-02-19,2024-08,2024-08-31,2023-07-25,ACTUAL,2023-07-25,2023-07-25,ACTUAL,2023-07-25,,INTERVENTIONAL,,The Full Analysis Set (FAS) included all randomized participants.,Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE),A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy,COMPLETED,,PHASE2,244.0,ACTUAL,Amgen,,4.0,,,f,,,,t,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,INDUSTRY,,,,,,,2023,0.0
NCT06003075,,2023-08-15,,,2024-09-23,2023-08-15,2023-08-21,ACTUAL,,,,,,,2024-09-23,2024-09-25,ACTUAL,2023-12-13,ACTUAL,2023-12-13,2024-09,2024-09-30,2024-07-05,ACTUAL,2024-07-05,2024-07-05,ACTUAL,2024-07-05,,INTERVENTIONAL,,,Induction Chemo-Nivo in Unresectable Stage III NSCLC,Phase II Study of Induction Platinum Doublet in Combination With Nivolumab Followed by Surgery or Concurrent Chemoradiation in Unresectable Stage IIIA-C Non-small Cell Lung Cancer (NSCLC),TERMINATED,,PHASE2,1.0,ACTUAL,University of Kentucky,,2.0,,Slow accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,OTHER,,,,,,,2024,0.0
NCT03318016,,2017-10-18,2022-01-05,,2024-02-20,2017-10-18,2017-10-23,ACTUAL,2024-02-20,2024-08-01,ACTUAL,,,,2024-02-20,2024-08-01,ACTUAL,2017-12-15,ACTUAL,2017-12-15,2024-02,2024-02-29,2021-01-20,ACTUAL,2021-01-20,2020-01-15,ACTUAL,2020-01-15,,INTERVENTIONAL,,Relapsed/Refractory Acute Myeloid Leukemia,Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia,Phase I Trial of Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia,TERMINATED,,PHASE1,5.0,ACTUAL,"University of Colorado, Denver",,5.0,,"Low enrollment, University Scientific Review Committee required study closure.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,OTHER,,,,,,,2021,0.0
NCT04230980,,2020-01-13,2023-09-22,,2023-10-17,2020-01-13,2020-01-18,ACTUAL,2023-10-17,2023-10-18,ACTUAL,,,,2023-10-17,2023-10-18,ACTUAL,2020-07-28,ACTUAL,2020-07-28,2023-10,2023-10-31,2022-12-16,ACTUAL,2022-12-16,2022-11-28,ACTUAL,2022-11-28,,INTERVENTIONAL,,1 subject on the gabapentin arm and 3 subjects on the placebo arm were excluded as data collected from these participants was insufficient for analysis.,Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery,The Use of Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery,COMPLETED,,PHASE3,74.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,OTHER,,,,,,,2022,1.0
NCT01748825,,2012-12-11,2021-06-29,,2021-06-29,2012-12-11,2012-12-13,ESTIMATED,2021-06-29,2021-07-26,ACTUAL,,,,2021-06-29,2021-07-26,ACTUAL,2012-12-19,ACTUAL,2012-12-19,2021-06,2021-06-30,2020-05-19,ACTUAL,2020-05-19,2020-05-19,ACTUAL,2020-05-19,,INTERVENTIONAL,,,AZD1775 for Advanced Solid Tumors,"A Phase I Study of Single-agent AZD1775 (MK-1775), a Wee1 Inhibitor, in Patients With Advanced Refractory Solid Tumors",COMPLETED,,PHASE1,67.0,ACTUAL,National Institutes of Health Clinical Center (CC),,10.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,NIH,,,,,,,2020,1.0
NCT05753735,,2023-02-22,2024-08-14,,2024-09-17,2023-02-22,2023-03-03,ACTUAL,2024-09-17,2024-09-24,ACTUAL,,,,2024-09-17,2024-09-24,ACTUAL,2024-01-18,ACTUAL,2024-01-18,2024-09,2024-09-30,2024-06-02,ACTUAL,2024-06-02,2024-03-14,ACTUAL,2024-03-14,,INTERVENTIONAL,,The number of participants analyzed in the standard perioperative antibiotic group is zero because no patients were randomized to this arm.,eXtended Antibiotic Prophylaxis for Intermediate- and High-risk Glands After Pancreatoduodenectomy to Reduce CR-POPF,eXtended Antibiotic Prophylaxis for Intermediate- and High-risk Glands After Pancreatoduodenectomy to Reduce Clinically Relevant PostOperative Pancreatic Fistula: A Phase 2 Randomized Control Trial (X-POPF),TERMINATED,,PHASE2,3.0,ACTUAL,Case Comprehensive Cancer Center,"The Principal Investigator left University Hospitals Cleveland Medical Center. Therefore, this clinical trial was terminated prematurely.",2.0,,Principal investigator left the institution.,f,,,,,t,f,,,,,,,,,YES,,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,OTHER,,,,,,,2024,0.0
NCT03507543,,2018-01-08,,,2021-03-27,2018-04-15,2018-04-25,ACTUAL,,,,,,,2021-03-27,2021-03-30,ACTUAL,2017-02-03,ACTUAL,2017-02-03,2021-03,2021-03-31,2021-03-17,ACTUAL,2021-03-17,2020-09-24,ACTUAL,2020-09-24,,INTERVENTIONAL,,,The Safety and Pharmacokinetics of IMP4297 in Patients With Advanced Solid Tumors,"A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of IMP4297 in Patients With Advanced Solid Tumors",COMPLETED,,PHASE1,39.0,ACTUAL,"Impact Therapeutics, Inc.",,1.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,INDUSTRY,,,,,,,2021,1.0
NCT03989635,,2019-06-14,,,2020-05-12,2019-06-14,2019-06-18,ACTUAL,,,,,,,2020-05-12,2020-05-14,ACTUAL,2019-10-15,ESTIMATED,2019-10-15,2020-05,2020-05-31,2021-06-14,ESTIMATED,2021-06-14,2021-06-14,ESTIMATED,2021-06-14,,INTERVENTIONAL,,,Mechanistic Study of Anti-inflammatory Effects of Fevipiprant in Patients With Eosinophilic Asthma.,"Randomized, Subject and Investigator Blinded, Placebo-controlled Study to Demonstrate the Anti-inflammatory Effect of Fevipiprant (QAW039) in Moderate to Severe Asthma Patients With High Sputum and Blood Eosinophils.",WITHDRAWN,,PHASE2,0.0,ACTUAL,Novartis,,2.0,,Company Decision,f,,,,f,t,f,,,,,,,,,UNDECIDED,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,INDUSTRY,,,,,,,2021,0.0
NCT04983407,,2021-07-08,,,2023-10-26,2021-07-20,2021-07-30,ACTUAL,,,,,,,2023-10-26,2023-10-30,ACTUAL,2021-07-28,ACTUAL,2021-07-28,2023-10,2023-10-31,2023-08-14,ACTUAL,2023-08-14,2023-08-14,ACTUAL,2023-08-14,,INTERVENTIONAL,,,Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma,A Phase 1b/2 Randomized Study of AVB-S6-500 Plus Nab-paclitaxel and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma,TERMINATED,,PHASE1/PHASE2,34.0,ACTUAL,"Aravive, Inc.",,3.0,,Due to business reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,INDUSTRY,,,,,,,2023,0.0
NCT03677115,,2018-09-16,,,2021-11-05,2018-09-18,2018-09-19,ACTUAL,,,,,,,2021-11-05,2021-11-12,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2021-11,2021-11-30,2023-03-30,ESTIMATED,2023-03-30,2023-03-30,ESTIMATED,2023-03-30,,INTERVENTIONAL,,,Thoracic Paravertebral Blocks Using a Combination of Ropivacaine and Dexmedetomidine,Thoracic Paravertebral Blocks Using a Combination of Ropivacaine and Dexmedetomidine,WITHDRAWN,,PHASE4,0.0,ACTUAL,"China Medical University, China",,1.0,,no participants enrolled,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,OTHER,,,,,,,2023,0.0
NCT02898259,,2016-09-08,2020-09-22,,2022-09-14,2016-09-08,2016-09-13,ESTIMATED,2021-01-08,2021-01-13,ACTUAL,,,,2022-09-14,2022-09-26,ACTUAL,2017-02-20,ACTUAL,2017-02-20,2022-09,2022-09-30,2022-06-06,ACTUAL,2022-06-06,2018-10-23,ACTUAL,2018-10-23,,INTERVENTIONAL,,Participants enrolled in study,"Lenalidomide, Ixazomib, and Rituximab as Front-Line Therapy for High Risk Indolent B-Cell Lymphoma","A Phase IB/II Trial of Lenalidomide (Revlimid®), Ixazomib and Rituximab (RIXAR) as Front-line Therapy for High Risk Indolent B Cell Lymphoma",TERMINATED,,PHASE1/PHASE2,19.0,ACTUAL,Case Comprehensive Cancer Center,,1.0,,Funding was eliminated.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,OTHER,,,,,,,2022,0.0
NCT03221751,,2017-07-13,2024-01-24,2023-12-20,2024-02-22,2017-07-17,2017-07-19,ACTUAL,2024-02-22,2024-02-26,ACTUAL,,2024-01-05,ACTUAL,2024-02-22,2024-02-26,ACTUAL,2016-12-01,ACTUAL,2016-12-01,2024-02,2024-02-29,2023-12-05,ACTUAL,2023-12-05,2023-01-03,ACTUAL,2023-01-03,,INTERVENTIONAL,PoND,,Prazosin and Cerebrospinal Fluid (CSF) Biomarkers in Mild Traumatic Brain Injury (mTBI),Prazosin and CSF Biomarkers in mTBI,TERMINATED,,PHASE4,9.0,ACTUAL,VA Office of Research and Development,These results are not generalizable due to the small sample size.,2.0,,staffing issues and COVID,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,FED,,,,,,,2023,0.0
NCT04362137,,2020-04-22,2021-04-15,,2021-10-07,2020-04-22,2020-04-24,ACTUAL,2021-05-28,2021-06-02,ACTUAL,,,,2021-10-07,2021-10-11,ACTUAL,2020-05-02,ACTUAL,2020-05-02,2021-10,2021-10-31,2020-10-17,ACTUAL,2020-10-17,2020-10-17,ACTUAL,2020-10-17,,INTERVENTIONAL,RUXCOVID,,Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm,"Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID)",COMPLETED,,PHASE3,432.0,ACTUAL,Novartis,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,INDUSTRY,,,,,,,2020,1.0
NCT05051150,,2021-09-10,,,2022-02-23,2021-09-10,2021-09-21,ACTUAL,,,,,,,2022-02-23,2022-03-10,ACTUAL,2021-09-15,ACTUAL,2021-09-15,2022-02,2022-02-28,2021-11-01,ACTUAL,2021-11-01,2021-11-01,ACTUAL,2021-11-01,,INTERVENTIONAL,,,Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Caesarean Section,The Use of Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery: a Randomized Controlled Dose-finding Trial,TERMINATED,,PHASE4,18.0,ACTUAL,Kasr El Aini Hospital,,3.0,,tachycardia and arrhythmia in the high doses groups 0.05 and 0.07 necessitate stopping the infusion,f,,,,f,f,f,,,,,,,,,,,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,OTHER,,,,,,,2021,0.0
NCT04452474,,2020-06-25,,,2021-10-29,2020-06-26,2020-06-30,ACTUAL,,,,,,,2021-10-29,2021-11-08,ACTUAL,2020-06-30,ESTIMATED,2020-06-30,2021-10,2021-10-31,2021-01-29,ESTIMATED,2021-01-29,2020-11-16,ESTIMATED,2020-11-16,,INTERVENTIONAL,,,Study of the Efficacy and Safety of a Single Administration of Olokizumab vs. Placebo in Addition to Standard Treatment in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19).,"A Multicenter, Randomized, Double-blind, Adaptive, Placebo-controlled Study of the Efficacy and Safety of a Single Administration of Olokizumab vs. Placebo in Addition to Standard Treatment in Patients With Severe SARS-CoV-2 Infection (COVID-19)",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,R-Pharm,,2.0,,Sponsor's decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,INDUSTRY,,,,,,,2021,0.0
NCT03680911,,2018-08-29,2020-12-21,,2021-02-03,2018-09-19,2018-09-21,ACTUAL,2021-02-03,2021-02-04,ACTUAL,,,,2021-02-03,2021-02-04,ACTUAL,2018-10-12,ACTUAL,2018-10-12,2021-02,2021-02-28,2020-01-07,ACTUAL,2020-01-07,2020-01-07,ACTUAL,2020-01-07,,INTERVENTIONAL,,,NAC for Head Trauma-induced Anosmia,Early N-Acetyl Cysteine Treatment for Head Trauma-induced Anosmia,TERMINATED,,PHASE3,7.0,ACTUAL,University of Miami,,2.0,,Poor participant compliance,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,OTHER,,,,,,,2020,0.0
NCT03781089,,2018-12-18,,,2023-06-28,2018-12-18,2018-12-19,ACTUAL,,,,,,,2023-06-28,2023-06-29,ACTUAL,2019-06-20,ACTUAL,2019-06-20,2023-04,2023-04-30,2023-03-15,ACTUAL,2023-03-15,2023-03-15,ACTUAL,2023-03-15,,INTERVENTIONAL,,,Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients,Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients Treated With Hemodialysis (PEARL-HD),COMPLETED,,PHASE4,36.0,ACTUAL,Duke University,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,Participant level data will not be shared.,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,OTHER,,,,,,,2023,1.0
NCT05088967,,2021-09-28,,,2024-01-12,2021-10-11,2021-10-22,ACTUAL,,,,,,,2024-01-12,2024-01-16,ACTUAL,2021-12-02,ACTUAL,2021-12-02,2024-01,2024-01-31,2023-12-25,ACTUAL,2023-12-25,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Efficacy and Safety of IBI110 in Combination With Sintilimab Versus Sintilimab Alone in Neoadjuvant and Adjuvant Therapy of Radically Resectable Non-small Cell Lung Cancer,"A Randomized, Open-label, Phase Ib Clinical Study to Evaluate the Efficacy and Safety of IBI110 in Combination With Sintilimab Versus Sintilimab Alone in Neoadjuvant and Adjuvant Therapy of Radically Resectable Non-small Cell Lung Cancer",TERMINATED,,PHASE1,6.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,2.0,,Development strategy adjustment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,INDUSTRY,,,,,,,2023,0.0
NCT03443973,,2018-02-19,2023-09-22,,2023-12-22,2018-02-19,2018-02-23,ACTUAL,2023-12-22,2024-01-17,ACTUAL,,,,2023-12-22,2024-01-17,ACTUAL,2018-08-22,ACTUAL,2018-08-22,2023-12,2023-12-31,2022-11-28,ACTUAL,2022-11-28,2022-09-23,ACTUAL,2022-09-23,,INTERVENTIONAL,,"Intent-to-treat (ITT) analysis set included all participants randomized during the global phase, who received at least one dose of study drug.",Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD),"A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease",TERMINATED,,PHASE3,975.0,ACTUAL,Hoffmann-La Roche,,2.0,,Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I\&II (WN29922/WN39658).,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,INDUSTRY,,,,,,,2022,0.0
NCT04826484,,2021-03-29,2023-12-06,,2023-12-06,2021-03-29,2021-04-01,ACTUAL,2023-12-06,2023-12-26,ACTUAL,,,,2023-12-06,2023-12-26,ACTUAL,2021-10-01,ACTUAL,2021-10-01,2023-12,2023-12-31,2023-04-26,ACTUAL,2023-04-26,2023-04-26,ACTUAL,2023-04-26,,INTERVENTIONAL,Baby ORIOLES,,Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel,A Randomized Trial Evaluating Use of Long-Acting Liposomal Bupivacaine (Exparel®) in Reducing Narcotic Pain Requirements in Pediatric Patients Undergoing Minor Urologic Procedures,TERMINATED,,PHASE3,104.0,ACTUAL,Johns Hopkins University,The trial met the predetermined threshold for early stopping.~1. Inability to blind surgeons due to differences in the appearance of the agents.~2. Unclear if the absorption profile of intervention is more rapid in groin/dorsal penile tissue compared to other areas.~3. Our cohort was enriched with low morbidity procedures which may have decreased differences between arms~4. Inability to compare the efficacy of the agents stratified by procedure type due to low enrollment in each procedure,2.0,,Met futility threshold at interim analysis,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-17 00:36:18.791631,2024-10-17 00:36:18.791631,OTHER,,,,,,,2023,0.0
NCT05518422,,2022-08-24,,,2024-02-15,2022-08-24,2022-08-26,ACTUAL,,,,,,,2024-02-15,2024-02-20,ACTUAL,2024-02,ESTIMATED,2024-02-29,2024-02,2024-02-29,2024-02,ESTIMATED,2024-02-29,2024-02,ESTIMATED,2024-02-29,,INTERVENTIONAL,,,Role of Endothelin-1 Modulating Insulin-stimulated Blood Flow and Sympathetic Nervous System Activity in Obesity,Role of Endothelin-1 Modulating Insulin-stimulated Blood Flow and Sympathetic Nervous System Activity in Obesity,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Missouri-Columbia,,1.0,,No participants enrolled,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,OTHER,,,,,,,2024,0.0
NCT05221320,,2021-12-20,,,2024-07-18,2022-01-20,2022-02-02,ACTUAL,,,,,,,2024-07-18,2024-07-22,ACTUAL,2022-05-26,ACTUAL,2022-05-26,2024-07,2024-07-31,2024-07-14,ACTUAL,2024-07-14,2024-05-08,ACTUAL,2024-05-08,,INTERVENTIONAL,,,Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies,A Phase 2 Basket Trial of Ulixertinib (BVD-523) in Combination With Hydroxychloroquine in Patients With Advanced GI Malignancies Harboring Mitogen-activated Protein Kinase (MAPK) Pathway Mutations (BVD-523-HCQ),TERMINATED,,PHASE2,47.0,ACTUAL,"BioMed Valley Discoveries, Inc",,2.0,,Lack of Enrollment for Remaining Open Baskets,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,INDUSTRY,,,,,,,2024,0.0
NCT03128619,,2017-04-04,,,2022-09-22,2017-04-20,2017-04-25,ACTUAL,,,,,,,2022-09-22,2022-09-26,ACTUAL,2017-08-02,ACTUAL,2017-08-02,2021-04,2021-04-30,2022-03-31,ACTUAL,2022-03-31,2022-03-31,ACTUAL,2022-03-31,,INTERVENTIONAL,,,"Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer","A Phase Ib Trial Evaluating the Safety of Copanlisib, Letrozole, and Palbociclib in Metastatic Breast Cancer and Phase II Trial Comparing the Molecular Effects of Neoadjuvant Copanlisib in Combination With Palbociclib and Letrozole, vs. Copanlisib With Letrozole, vs. Palbociclib With Letrozole for Patients With Hormone Receptor Positive, HER2 Normal Breast Cancer",TERMINATED,,PHASE1,10.0,ACTUAL,Jonsson Comprehensive Cancer Center,,4.0,,Insufficient accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,OTHER,,,,,,,2022,0.0
NCT04116203,,2018-05-05,,,2024-03-25,2019-10-02,2019-10-04,ACTUAL,,,,,,,2024-03-25,2024-03-27,ACTUAL,2016-06-30,ACTUAL,2016-06-30,2024-03,2024-03-31,2024-12-30,ESTIMATED,2024-12-30,2024-12-30,ESTIMATED,2024-12-30,,INTERVENTIONAL,PCOS,,Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS),Dietary Fish Oil Intervention in Polycystic Ovary Syndrome,SUSPENDED,,PHASE1,180.0,ESTIMATED,University of Alberta,,3.0,,waiting for additional funding to complete trial,f,,,,t,f,f,,,f,,,,,,NO,There will be no sharing with other researchers.,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,OTHER,,,,,,,2024,0.0
NCT03560011,,2018-06-06,,,2021-10-01,2018-06-06,2018-06-18,ACTUAL,,,,,,,2021-10-01,2021-10-04,ACTUAL,2019-04-03,ACTUAL,2019-04-03,2021-10,2021-10-31,2022-11-04,ESTIMATED,2022-11-04,2021-01-07,ACTUAL,2021-01-07,,INTERVENTIONAL,RITUXIVIG,,Efficacy and Safety of Immunoglobulin Associated With Rituximab Versus Rituximab Alone in Childhood-Onset Steroid-dependent Nephrotic Syndrome,Efficacy and Safety of Immunoglobulin Associated With Rituximab Versus Rituximab Alone in Childhood-Onset Steroid-dependent Nephrotic Syndrome,SUSPENDED,,PHASE2/PHASE3,90.0,ESTIMATED,Assistance Publique - Hôpitaux de Paris,,2.0,,Decision of Data Safety Monitoring Board,f,,,,t,f,f,,,,,,,,,YES,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,OTHER,,,,,,,2022,0.0
NCT03003728,,2016-12-21,,,2020-07-08,2016-12-21,2016-12-28,ESTIMATED,,,,,,,2020-07-08,2020-07-10,ACTUAL,2019-11-01,ACTUAL,2019-11-01,2020-07,2020-07-31,2020-07-08,ACTUAL,2020-07-08,2020-07-08,ACTUAL,2020-07-08,,INTERVENTIONAL,,,2015-10: Expanded Natural Killer Cells and Elotuzumab for High-Risk Myeloma Post- Autologous Stem Cell Transplant (ASCT),2015-10: A Phase II Pilot Study of Expanded Natural Killer Cells and Elotuzumab to Eradicate High-Risk Myeloma Post Autologous Stem Cell Transplant,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Arkansas,,1.0,,Withdrawal of study support,f,,,,f,t,f,,,,,,,,,,,2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,OTHER,,,,,,,2020,0.0
NCT05027815,,2021-08-26,2023-03-17,,2023-05-08,2021-08-26,2021-08-30,ACTUAL,2023-05-08,2023-06-05,ACTUAL,,,,2023-05-08,2023-06-05,ACTUAL,2021-09-23,ACTUAL,2021-09-23,2023-05,2023-05-31,2022-03-02,ACTUAL,2022-03-02,2022-03-02,ACTUAL,2022-03-02,,INTERVENTIONAL,regARDS,,Tregs for the Treatment of Acute Respiratory Distress Syndrome (ARDS) Associated With COVID-19 (regARDS),A Phase 1/2a Study of Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells (cePolyTregs) for the Treatment of Acute Respiratory Distress Syndrome (ARDS) Associated With SARS-CoV-2 Infection (regARDS),TERMINATED,,PHASE1,7.0,ACTUAL,"University of California, San Francisco","The trial was terminated early due to a decline in the available participants, which prevent the analysis of some secondary and exploratory endpoints from completion as initially planned. The safety and tolerability, and recommended phase 2 dose can not be determined based on the limited data.",3.0,,Decrease in COVID-19 cases made further enrollment infeasible.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,OTHER,,,,,,,2022,0.0
NCT03868839,,2019-03-06,2021-12-07,,2022-02-07,2019-03-06,2019-03-11,ACTUAL,2022-02-07,2022-03-02,ACTUAL,,,,2022-02-07,2022-03-02,ACTUAL,2019-02-01,ACTUAL,2019-02-01,2022-02,2022-02-28,2020-10-07,ACTUAL,2020-10-07,2020-10-07,ACTUAL,2020-10-07,,INTERVENTIONAL,,Study is terminated due to lack of funding.,Telmisartan Pilot Study on Treatment Resistant Schizophrenia,An Open-label Feasibility Trial of Adjunctive Telmisartan in Patients With Treatment Resistant Schizophrenia,TERMINATED,,PHASE2,6.0,ACTUAL,"University of Massachusetts, Worcester",The overall limitations and caveat is that this study is a pilot study with small sample size (6 subjects).,1.0,,Lack of funding,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,OTHER,,,,,,,2020,0.0
NCT03126461,,2017-03-23,,,2020-08-19,2017-04-21,2017-04-24,ACTUAL,,,,,,,2020-08-19,2020-08-20,ACTUAL,2018-03-01,ESTIMATED,2018-03-01,2018-04,2018-04-30,2022-12-31,ESTIMATED,2022-12-31,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients,Phase 2 Trial of SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Texas Southwestern Medical Center,,1.0,,"the project was never initiated and no participants were enrolled, it was closed permanently",f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,OTHER,,,,,,,2022,0.0
NCT03280056,,2017-08-29,2023-12-01,2021-10-03,2024-02-05,2017-09-10,2017-09-12,ACTUAL,2024-02-05,2024-02-29,ACTUAL,,2024-02-29,ACTUAL,2024-02-05,2024-02-29,ACTUAL,2017-08-28,ACTUAL,2017-08-28,2024-02,2024-02-29,2020-09-29,ACTUAL,2020-09-29,2020-09-29,ACTUAL,2020-09-29,,INTERVENTIONAL,,Demographic characteristics were balanced between NurOwn and placebo treatment groups with no statistically significant differences at baseline.,Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients,"A Phase 3, Randomized Double-Blind, Placebo-Controlled Multicenter Study to Evaluate Efficacy and Safety of Repeated Administration of NurOwn® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors) in Participants With ALS",COMPLETED,,PHASE3,196.0,ACTUAL,Brainstorm-Cell Therapeutics,"This trial had a unique and atypical trial population that included more participants than anticipated with advanced ALS, who had a low ALSFRS-R score. As compared with recent large ALS clinical trials, this study population is an outlier, with a mean overall ALSFRS-R score at baseline lower than other studies, and this impacted the power of this study.",2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,INDUSTRY,,,,,,,2020,1.0
NCT03674827,,2018-08-29,2022-08-03,,2024-03-27,2018-09-14,2018-09-18,ACTUAL,2024-03-27,2024-08-23,ACTUAL,,,,2024-03-27,2024-08-23,ACTUAL,2018-11-27,ACTUAL,2018-11-27,2024-03,2024-03-31,2021-09-27,ACTUAL,2021-09-27,2021-09-27,ACTUAL,2021-09-27,,INTERVENTIONAL,,All enrolled participants who received at least 1 dose of one of the components of the regimen.,Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC,"A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES AND TREATMENT INTENSIFICATION OF A VACCINE-BASED IMMUNOTHERAPY REGIMEN-2 (VBIR-2) (PF-06936308) FOR ADVANCED NON-SMALL CELL LUNG CANCER AND METASTATIC TRIPLE-NEGATIVE BREAST CANCER",TERMINATED,,PHASE1,36.0,ACTUAL,Pfizer,"This study was terminated on 10 Feb 2021 by the Sponsor. The decision to terminate this study was based on the results of a strategic evaluation of VBIR-2 within the current Sponsor's oncology portfolio. When the decision of study termination was made, participants enrolled in Part 1 who were still on study were to remain on treatment until 31 Aug 2021; Part 2 of the study was never opened.",2.0,,The study was terminated due to the review of the asset (VBIR-2) within the Sponsor's oncology portfolio; the study was not terminated because of safety concerns.,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,INDUSTRY,,,,,,,2021,0.0
NCT03341962,,2017-11-08,2023-11-16,,2024-02-06,2017-11-09,2017-11-14,ACTUAL,2024-02-06,2024-03-05,ACTUAL,,,,2024-02-06,2024-03-05,ACTUAL,2018-03-15,ACTUAL,2018-03-15,2024-02,2024-02-29,2022-11-16,ACTUAL,2022-11-16,2022-11-16,ACTUAL,2022-11-16,,INTERVENTIONAL,CALDOSE-1,"In the IP, one patient received erroneously 30 mg IMU-838 instead of placebo and was included in the 30 mg IMU-838 group for the safety analysis set (SAF), as in participant flow, but in the placebo group for the full analysis set (FAS). Demographics and baseline characteristics were analyzed for the FAS.~Not all participants who completed or discontinued the IP continued to the MP or OLE. Patients were re-randomized at the start of MP (except the placebo group).",Phase 2 Dose-finding IMU-838 for Ulcerative Colitis,"A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of IMU-838 for Induction and Maintenance Therapy in Moderate-to-severe Ulcerative Colitis",TERMINATED,,PHASE2,263.0,ACTUAL,Immunic AG,,8.0,,"Considering the efficacy results of the induction phase (allowed use of corticosteroids as concomitant medication) in the study population and since IMU-838 did not show superiority over placebo, the OLE was prematurely closed by the sponsor.",f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,INDUSTRY,,,,,,,2022,0.0
NCT05312970,,2022-03-29,,,2024-09-23,2022-03-29,2022-04-06,ACTUAL,,,,,,,2024-09-23,2024-09-25,ACTUAL,2023-02-10,ACTUAL,2023-02-10,2024-09,2024-09-30,2024-04-04,ACTUAL,2024-04-04,2024-04-04,ACTUAL,2024-04-04,,INTERVENTIONAL,VERITAS,,Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS),A Phase 4 Randomized Trial Comparing Varithena to Endothermal Ablation for the Treatment of the Great Saphenous Vein,TERMINATED,,PHASE4,43.0,ACTUAL,Boston Scientific Corporation,,2.0,,Enrollment challenges and a difficult insurance coverage landscape,f,,,,f,t,t,,,f,,,,,,NO,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,INDUSTRY,,,,,,,2024,0.0
NCT03385057,,2017-12-20,,,2018-09-19,2017-12-20,2017-12-28,ACTUAL,,,,,,,2018-09-19,2018-09-20,ACTUAL,2018-09,ESTIMATED,2018-09-30,2018-09,2018-09-30,2023-01-01,ESTIMATED,2023-01-01,2023-01-01,ESTIMATED,2023-01-01,,INTERVENTIONAL,,,Postoperative Ibuprofen Use and Risk of Bleeding in Pediatric Tonsillectomy,Postoperative Ibuprofen Use and Risk of Bleeding in Pediatric Tonsillectomy,WITHDRAWN,,PHASE1,0.0,ACTUAL,Massachusetts Eye and Ear Infirmary,,2.0,,Study design flaws; research design needed to be reconfigured,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,OTHER,,,,,,,2023,0.0
NCT04578548,,2020-10-01,2024-03-26,,2024-03-26,2020-10-01,2020-10-08,ACTUAL,2024-03-26,2024-08-22,ACTUAL,,,,2024-03-26,2024-08-22,ACTUAL,2020-11-10,ACTUAL,2020-11-10,2024-03,2024-03-31,2023-04-04,ACTUAL,2023-04-04,2022-12-14,ACTUAL,2022-12-14,,INTERVENTIONAL,,Safety Analysis Set (SAS): All randomized participants who received at least one dose of study drug.,A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD),"An Exploratory, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Orally Administered GLPG2737 for 52 Weeks, Followed by an Open-label Extension Period of 52 Weeks in Participants With Autosomal Dominant Polycystic Kidney Disease",TERMINATED,,PHASE2,66.0,ACTUAL,Galapagos NV,"The early termination was decided due to the lack of efficacy of GLPG2737, making the expected benefit-risk balance negative.",2.0,,The study was early terminated due to lack of efficacy.,f,,,,t,f,f,,,t,,,,,,NO,,2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,INDUSTRY,,,,,,,2023,0.0
NCT05372887,,2022-05-09,,,2023-12-04,2022-05-09,2022-05-13,ACTUAL,,,,,,,2023-12-04,2023-12-11,ACTUAL,2022-10-14,ACTUAL,2022-10-14,2023-12,2023-12-31,2022-11-08,ACTUAL,2022-11-08,2022-11-08,ACTUAL,2022-11-08,,INTERVENTIONAL,,,Safety and Efficacy Study of TNX-102 SL in Participants With PTSD,"A Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Daily Bedtime TNX-102 SL in Participants With PTSD",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Tonix Pharmaceuticals, Inc.",,2.0,,The study was stopped due to business reasons.,f,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-15 15:42:44.728117,2024-10-15 15:42:44.728117,INDUSTRY,,,,,,,2022,0.0
NCT03705637,,2018-09-29,,,2023-02-28,2018-10-10,2018-10-15,ACTUAL,,,,,,,2023-02-28,2023-03-02,ACTUAL,2019-06-01,ACTUAL,2019-06-01,2023-02,2023-02-28,2020-03-24,ACTUAL,2020-03-24,2020-03-24,ACTUAL,2020-03-24,,INTERVENTIONAL,,,Liposomal Bupivicaine for Skin Graft Donor Sites in Burn Patients,Evaluation of Liposomal Bipivicaine in Split Thickness Skin Graft Donor Sites in Burn Patients,TERMINATED,,EARLY_PHASE1,6.0,ACTUAL,Massachusetts General Hospital,,1.0,,"Patient population too low to reasonably continue study, pandemic had started at time of cessation, further leading to study discontinuation.",f,,,,f,t,f,,,f,,,,,,NO,IPD will not be shared with other researchers outside of those directly involved in this study.,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,OTHER,,,,,,,2020,0.0
NCT03457818,,2018-01-18,2021-04-17,,2024-06-06,2018-03-06,2018-03-08,ACTUAL,2021-04-17,2021-05-11,ACTUAL,,,,2024-06-06,2024-07-03,ACTUAL,2018-11-07,ACTUAL,2018-11-07,2024-06,2024-06-30,2020-06-10,ACTUAL,2020-06-10,2020-06-10,ACTUAL,2020-06-10,,INTERVENTIONAL,,Study terminated,Therapy of the Skeletal Disease of Type 2 Diabetes With Denosumab,Therapy of the Skeletal Disease of Type 2 Diabetes With Denosumab,TERMINATED,,PHASE2,8.0,ACTUAL,Columbia University,The study was terminated due to poor enrollment compounded by the COVID-19 pandemic. Data was not collected.,2.0,,Due to enrollment difficulties compounded by the COVID pandemic.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,OTHER,,,,,,,2020,0.0
NCT03486327,,2018-03-02,2024-07-11,,2024-08-22,2018-03-27,2018-04-03,ACTUAL,2024-08-22,2024-08-23,ACTUAL,,,,2024-08-22,2024-08-23,ACTUAL,2018-07-19,ACTUAL,2018-07-19,2024-08,2024-08-31,2021-07-31,ACTUAL,2021-07-31,2020-11-13,ACTUAL,2020-11-13,,INTERVENTIONAL,,"As of July 31, 2021, enrollment was terminated for Study BR55-110 due to expiration of available BR55. Therefore, only 4 participants were enrolled in the first cohort of this study (0.03 mL/kg). No participant was enrolled in the 0.05 mL/kg or 0.08 mL/kg groups.",Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions,Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions,TERMINATED,,PHASE2,4.0,ACTUAL,"Bracco Diagnostics, Inc",,3.0,,Sponsor decision; expiration of available study agent due to long recruitment timeline.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,INDUSTRY,,,,,,,2021,0.0
NCT02088112,,2014-03-07,,,2022-03-22,2014-03-12,2014-03-14,ESTIMATED,,,,,,,2022-03-22,2022-04-04,ACTUAL,2014-03-24,ACTUAL,2014-03-24,2022-03,2022-03-31,2021-03-09,ACTUAL,2021-03-09,2021-03-09,ACTUAL,2021-03-09,,INTERVENTIONAL,,,MEDI4736 (Anti PD-L1) Combined With Gefitinib in Subjects With Non-Small Cell Lung Cancer(NSCLC).,"A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Gefitinib in Combination With MEDI4736 (Anti PD-L1) in Subjects With Non-Small Cell Lung Cancer(NSCLC)",COMPLETED,,PHASE1,56.0,ACTUAL,MedImmune LLC,,2.0,,,f,,,,f,,,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,INDUSTRY,,,,,,,2021,0.0
NCT04265261,,2020-02-05,2024-07-16,,2024-08-30,2020-02-10,2020-02-11,ACTUAL,2024-08-30,2024-09-25,ACTUAL,,,,2024-08-30,2024-09-25,ACTUAL,2020-06-05,ACTUAL,2020-06-05,2024-08,2024-08-31,2023-07-19,ACTUAL,2023-07-19,2023-07-19,ACTUAL,2023-07-19,,INTERVENTIONAL,CANBERRA,,A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy,"A Randomized, Double-Masked, 48-Week, Parallel-Group, Placebo-Controlled, Proof-of-Concept Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy",COMPLETED,,PHASE2,139.0,ACTUAL,Hoffmann-La Roche,,3.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,INDUSTRY,,,,,,,2023,1.0
NCT03754140,,2018-10-31,,,2022-07-12,2018-11-22,2018-11-27,ACTUAL,,,,,,,2022-07-12,2022-07-14,ACTUAL,2020-05-20,ACTUAL,2020-05-20,2022-07,2022-07-31,2022-12,ESTIMATED,2022-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,INTRANS,,Intralesional Sclerosant for in Transit and Cutaneous Melanoma Metastases,Intralesional Sclerosant for in Transit and Cutaneous Melanoma Metastases,WITHDRAWN,,PHASE2,0.0,ACTUAL,Melanoma Institute Australia,,1.0,,Unable to identify eligible patients within planned timeframe,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,OTHER,,,,,,,2022,0.0
NCT03988231,,2019-06-13,,,2021-09-30,2019-06-13,2019-06-17,ACTUAL,,,,,,,2021-09-30,2021-10-08,ACTUAL,2021-07,ESTIMATED,2021-07-31,2021-09,2021-09-30,2023-06,ESTIMATED,2023-06-30,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,"Enoxaparin Versus Placebo for Venous Thromboembolism Prevention in Low Risk Cancer Patients After Surgical Procedures: a Randomized, Double Blind, Placebo Controlled Clinical Trial Pilot Study","Enoxaparin Versus Placebo for Venous Thromboembolism Prevention in Low Risk Cancer Patients After Surgical Procedures: a Randomized, Double Blind, Placebo Controlled Clinical Trial Pilot Study",WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Utah,,2.0,,Funding was not received.,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,OTHER,,,,,,,2023,0.0
NCT02228369,,2014-08-20,,,2021-01-04,2014-08-28,2014-08-29,ESTIMATED,,,,,,,2021-01-04,2021-01-05,ACTUAL,2014-11-05,ACTUAL,2014-11-05,2021-01,2021-01-31,2020-10-28,ACTUAL,2020-10-28,2017-08-19,ACTUAL,2017-08-19,,INTERVENTIONAL,BLOOM,,"Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors, AZD3759 or AZD9291, in Patients Who Have Advanced Non-Small Cell Lung Cancer","A Phase I, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumour Activity of AZD3759 or AZD9291 in Patients With EGFR Mutation Positive Advanced Stage Non Small Cell Lung Cancer (NSCLC)",COMPLETED,,PHASE1,108.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,f,,,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,INDUSTRY,,,,,,,2020,1.0
NCT03928275,,2019-04-11,,,2023-02-13,2019-04-23,2019-04-26,ACTUAL,,,,,,,2023-02-13,2023-02-14,ACTUAL,2021-12-01,ESTIMATED,2021-12-01,2023-02,2023-02-28,2022-09-01,ACTUAL,2022-09-01,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,,,The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma,The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Nova Scotia Health Authority,,2.0,,Withdrawn prematurely.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,OTHER,,,,,,,2022,0.0
NCT03263715,,2017-08-17,,,2021-01-20,2017-08-23,2017-08-28,ACTUAL,,,,,,,2021-01-20,2021-01-22,ACTUAL,2017-11-24,ACTUAL,2017-11-24,2021-01,2021-01-31,2020-06-02,ACTUAL,2020-06-02,2020-06-02,ACTUAL,2020-06-02,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE),"A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE)",COMPLETED,,PHASE3,39.0,ACTUAL,Medical University of Vienna,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,OTHER,,,,,,,2020,1.0
NCT05464420,,2022-07-12,2024-04-26,,2024-09-09,2022-07-12,2022-07-19,ACTUAL,2024-04-26,2024-05-24,ACTUAL,,,,2024-09-09,2024-09-24,ACTUAL,2022-08-12,ACTUAL,2022-08-12,2024-09,2024-09-30,2023-05-25,ACTUAL,2023-05-25,2023-05-25,ACTUAL,2023-05-25,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)","A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age",COMPLETED,,PHASE3,2162.0,ACTUAL,Merck Sharp & Dohme LLC,,4.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,INDUSTRY,,,,,,,2023,1.0
NCT04283136,,2020-02-21,,,2020-06-18,2020-02-21,2020-02-25,ACTUAL,,,,,,,2020-06-18,2020-06-22,ACTUAL,2020-02-24,ACTUAL,2020-02-24,2020-06,2020-06-30,2020-05-22,ACTUAL,2020-05-22,2020-05-22,ACTUAL,2020-05-22,,INTERVENTIONAL,,,A Study to Test the Blood Concentration of 4 Padsevonil Product Variants and the Effect of Food on Padsevonil,"An Open-Label, Randomized, Single-Dose, 2-Part Crossover Study in Healthy Study Participants to Evaluate the Relative Bioavailability of 4 Padsevonil Product Variants and the Effect of Food on Padsevonil",WITHDRAWN,,PHASE1,0.0,ACTUAL,UCB Pharma,,9.0,,"Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures",f,,,,f,t,f,,,f,,,,,,NO,"Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.",2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,INDUSTRY,,,,,,,2020,0.0
NCT04908956,,2021-05-21,,,2024-06-26,2021-05-28,2021-06-01,ACTUAL,,,,,,,2024-06-26,2024-06-28,ACTUAL,2022-08-04,ACTUAL,2022-08-04,2024-06,2024-06-30,2024-02-29,ACTUAL,2024-02-29,2023-10-31,ACTUAL,2023-10-31,,INTERVENTIONAL,STEREO,,Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR Mutant NSCLC (STEREO),A Multicentre Single-arm Phase II Trial Assessing the Safety and Efficacy of First-line Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR-mutant Non-small Cell Lung Cancer,TERMINATED,,PHASE2,6.0,ACTUAL,ETOP IBCSG Partners Foundation,,1.0,,The trial struggled with low activation due to the COVID pandemic. The Steering Committee took the decision to close the accrual in the STEREO trial as of 31 October 2023. It is important to note that no safety concerns have led to this decision.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,NETWORK,,,,,,,2024,0.0
NCT04800562,,2021-03-10,,,2023-08-01,2021-03-12,2021-03-16,ACTUAL,,,,,,,2023-08-01,2023-08-03,ACTUAL,2021-04-12,ACTUAL,2021-04-12,2023-08,2023-08-31,2023-04-14,ACTUAL,2023-04-14,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,,,A Clinical Trial to Evaluate PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica,"A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica",TERMINATED,,PHASE2,4.0,ACTUAL,Processa Pharmaceuticals,,2.0,,lack of enrollment of this ultra rare disease,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,INDUSTRY,,,,,,,2023,0.0
NCT03121989,,2017-02-10,,,2023-03-27,2017-04-17,2017-04-20,ACTUAL,,,,,,,2023-03-27,2023-03-30,ACTUAL,2017-11-21,ACTUAL,2017-11-21,2023-03,2023-03-31,2023-03-23,ACTUAL,2023-03-23,2023-03-23,ACTUAL,2023-03-23,,INTERVENTIONAL,LABC,,Study to Evaluate the Feasibility of 13-C Pyruvate Imaging in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy,Study to Evaluate the Feasibility of 13-C Pyruvate Imaging in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy,WITHDRAWN,,PHASE1,0.0,ACTUAL,Sunnybrook Health Sciences Centre,,2.0,,Funding completed,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,OTHER,,,,,,,2023,0.0
NCT03781726,,2018-12-18,2021-04-09,,2022-01-18,2018-12-18,2018-12-20,ACTUAL,2021-05-07,2021-05-11,ACTUAL,,,,2022-01-18,2022-01-26,ACTUAL,2019-04-10,ACTUAL,2019-04-10,2022-01,2022-01-31,2021-12-31,ACTUAL,2021-12-31,2020-03-20,ACTUAL,2020-03-20,,INTERVENTIONAL,MYTHIC,,Multi-center Study to Transplant Hepatitis-C Infected Kidneys,"A Multi-Center, Open-Label Study of Glecaprevir/Pibrentasvir to Treat Recipients of Transplanted Kidneys From Deceased Donors With Hepatitis C Virus",COMPLETED,,PHASE4,30.0,ACTUAL,Massachusetts General Hospital,,1.0,,,f,,,,t,t,f,,,f,,,Real time,researchers accessing IPD must be an approved site within the consortium.,,YES,Coded data is anticipated to be shared with collaborators in this multi-center consortium,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,OTHER,,,,,,,2021,1.0
NCT04727736,,2021-01-22,2024-01-23,2023-11-28,2024-01-23,2021-01-22,2021-01-27,ACTUAL,2024-01-23,2024-02-15,ACTUAL,,2024-01-19,ACTUAL,2024-01-23,2024-02-15,ACTUAL,2021-05-01,ACTUAL,2021-05-01,2024-01,2024-01-31,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,Patients that received study intervention and were radiologically evaluable.,18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer,Phase 2 Study of 18F-DCFPyL Positron Emission Tomography (PET) in Men With Intermediate or High Risk Biochemically Recurrent Prostate Cancer,TERMINATED,,PHASE2,47.0,ACTUAL,University of Pittsburgh,,1.0,,Intervention became FDA-approved,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,OTHER,,,,,,,2022,0.0
NCT02609386,,2015-09-10,2023-12-04,,2024-01-23,2015-11-17,2015-11-20,ESTIMATED,2024-01-23,2024-01-30,ACTUAL,,,,2024-01-23,2024-01-30,ACTUAL,2016-01-11,ACTUAL,2016-01-11,2024-01,2024-01-31,2022-02-28,ACTUAL,2022-02-28,2022-02-28,ACTUAL,2022-02-28,,INTERVENTIONAL,INSPIRE,,"IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity","A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy With the IRX 2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity",COMPLETED,,PHASE2,105.0,ACTUAL,"Brooklyn ImmunoTherapeutics, LLC","One of the initial secondary objectives of the study was to compare the feasibility of each booster regimen (Regimen 1 vs Regimen 2) post-surgery. However, as a significant number of patients were unable to receive booster treatments due to tolerability issues and/or their post-surgery/post-adjuvant chemoradiation therapy status, booster regimens were discontinued and analysis of booster feasibility was not performed due to insufficient data for a meaningful, statistically sound analysis.",2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,INDUSTRY,,,,,,,2022,1.0
NCT04906980,,2021-05-26,2024-02-05,,2024-02-05,2021-05-26,2021-05-28,ACTUAL,2024-02-05,2024-03-01,ACTUAL,,,,2024-02-05,2024-03-01,ACTUAL,2022-01-24,ACTUAL,2022-01-24,2024-01,2024-01-31,2023-03-21,ACTUAL,2023-03-21,2022-09-24,ACTUAL,2022-09-24,,INTERVENTIONAL,,,A Study of JNJ-64281802 in Participants With Confirmed Dengue Fever,"A Phase 2a, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Antiviral Activity, Safety and Tolerability, and Pharmacokinetics of JNJ-64281802 in Participants With Confirmed Dengue Fever",TERMINATED,,PHASE2,5.0,ACTUAL,"Janssen Research & Development, LLC","Since feasibility of enrollment was impacted by COVID, sponsor terminated the study. Due to small number of enrolled participants, planned data collection and analysis was not performed for the efficacy objectives and thus no data was reported for efficacy outcome measures.",2.0,,Feasibility of enrollment impacted by COVID,f,,,,f,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu",2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,INDUSTRY,,,,,,,2023,0.0
NCT04472494,,2020-07-14,2022-08-10,,2022-09-13,2020-07-14,2020-07-15,ACTUAL,2022-09-13,2022-10-07,ACTUAL,,,,2022-09-13,2022-10-07,ACTUAL,2020-10-14,ACTUAL,2020-10-14,2022-09,2022-09-30,2021-09-13,ACTUAL,2021-09-13,2021-08-12,ACTUAL,2021-08-12,,INTERVENTIONAL,,,Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise,"Phase 2, Randomized, Double-Blind Placebo Controlled Study of Intravenous Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise",TERMINATED,,PHASE2,61.0,ACTUAL,Bristol-Myers Squibb,,2.0,,Slow accrual,f,,,,,t,f,,,,,,,,,,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,INDUSTRY,,,,,,,2021,0.0
NCT02930122,,2016-10-07,2021-10-04,,2021-10-28,2016-10-07,2016-10-12,ESTIMATED,2021-10-04,2021-10-27,ACTUAL,,,,2021-10-28,2021-11-24,ACTUAL,2019-06-20,ACTUAL,2019-06-20,2021-10,2021-10-31,2020-10-16,ACTUAL,2020-10-16,2020-10-16,ACTUAL,2020-10-16,,INTERVENTIONAL,EASI ACL,6 participants had been enrolled at the time the study was closed (3 participants in each group),IL-1RA Treatment in Patients With Acute ACL Tear and Painful Effusions,"A Prospective, Single-Center, Randomized, Triple-Blinded, Placebo-Controlled Study of IL-1RA Treatment in Patients With Acute ACL Tear and Painful Effusions",TERMINATED,,PHASE2,6.0,ACTUAL,University of Kentucky,,2.0,,Lack of funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,OTHER,,,,,,,2020,0.0
NCT03027973,,2017-01-15,,,2020-01-25,2017-01-18,2017-01-23,ESTIMATED,,,,,,,2020-01-25,2020-01-28,ACTUAL,2020-01,ESTIMATED,2020-01-31,2020-01,2020-01-31,2020-01-17,ACTUAL,2020-01-17,2020-01,ESTIMATED,2020-01-31,,INTERVENTIONAL,,,Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding,Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding: A Pilot Randomized Control Trial,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Saskatchewan,,2.0,,PI made the decision to not continue the study. It was at the Health Canada review stage.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,OTHER,,,,,,,2020,0.0
NCT05743777,,2023-02-09,,,2023-05-16,2023-02-22,2023-02-24,ACTUAL,,,,,,,2023-05-16,2023-05-18,ACTUAL,2023-05-12,ACTUAL,2023-05-12,2023-05,2023-05-31,2023-05-12,ACTUAL,2023-05-12,2023-05-12,ACTUAL,2023-05-12,,INTERVENTIONAL,PROMOTE-HN,,PembROlizumab With or Without Microbial EcOsystem ThErapeutic 4 (MET4) in Advanced Head and Neck Squamous Cell Carcinoma,A Phase II Study of PembROlizumab With or Without Microbial EcOsystem ThErapeutic 4 (MET4) in Advanced Head and Neck Squamous Cell Carcinoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,Canadian Cancer Trials Group,,2.0,,Company withdrew financial support,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,NETWORK,,,,,,,2023,0.0
NCT05176717,,2021-11-23,2022-11-03,,2024-07-11,2022-01-03,2022-01-04,ACTUAL,2022-12-28,2023-01-20,ACTUAL,,,,2024-07-11,2024-08-07,ACTUAL,2021-12-15,ACTUAL,2021-12-15,2024-07,2024-07-31,2022-08-02,ACTUAL,2022-08-02,2022-08-02,ACTUAL,2022-08-02,,INTERVENTIONAL,,,Study to Evaluate the Efficacy Safety and Tolerability of QR-421a in Subjects With RP Due to Mutations in Exon 13 of the USH2A Gene With Early to Moderate Vision Loss (Celeste),"A Double-Masked, Randomized, Controlled, Multiple-Dose Study to Evaluate the Efficacy, Safety and Tolerability of QR-421a in Subjects With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene With Early to Moderate Vision Loss",TERMINATED,,PHASE2/PHASE3,5.0,ACTUAL,Laboratoires Thea,Study prematurely terminated due to sponsor decision for reasons unrelated to safety,3.0,,Business decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,INDUSTRY,,,,,,,2022,0.0
NCT05221749,,2021-12-25,2022-11-20,,2023-07-25,2022-01-29,2022-02-03,ACTUAL,2023-07-25,2023-08-18,ACTUAL,,,,2023-07-25,2023-08-18,ACTUAL,2022-03-15,ACTUAL,2022-03-15,2023-07,2023-07-31,2022-06-15,ACTUAL,2022-06-15,2022-04-15,ACTUAL,2022-04-15,,INTERVENTIONAL,,Children 4-6 years old with at least 1 active dentin caries lesion.,The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth,The Antibacterial Effect of Nanosilver Fluoride in Relation to Caries Activity in Primary Teeth: a Randomized Controlled Clinical Trial,TERMINATED,,PHASE3,50.0,ACTUAL,Alexandria University,,2.0,,Only the 1 month follow-up was completed. The principal investigator could not complete the 3 month follow-up appointments and was not calibrated with other dentists who were available at the time.,f,,,,t,t,f,,,t,,,,,,NO,Each participant will be provided with a serial number that will only be accessible to the principal investigator. No data regarding the identity of the participants will be shared under any circumstances. All participants or their guardians must provide a written informed consent prior to any procedures.,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,OTHER,,,,,,,2022,0.0
NCT04865029,,2021-04-21,2023-02-10,,2023-06-05,2021-04-27,2021-04-29,ACTUAL,2023-06-05,2023-06-27,ACTUAL,,,,2023-06-05,2023-06-27,ACTUAL,2021-07-22,ACTUAL,2021-07-22,2023-06,2023-06-30,2022-01-25,ACTUAL,2022-01-25,2022-01-25,ACTUAL,2022-01-25,,INTERVENTIONAL,,,Estradiol and Progesterone in Hospitalized COVID-19 Patients,Acute Estradiol and Progesterone Therapy in Hospitalized Adults to Reduce Coronavirus Disease (COVID-19) Severity: A Randomized Control Trial,TERMINATED,,PHASE2,10.0,ACTUAL,Tulane University,Early termination leading to small numbers of subjects analyzed,2.0,,Lack of enrollment due to change of COVID 19 variant prevalence,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,OTHER,,,,,,,2022,0.0
NCT03365661,,2017-12-03,,,2018-11-07,2017-12-03,2017-12-07,ACTUAL,,,,,,,2018-11-07,2018-11-09,ACTUAL,2018-10-30,ESTIMATED,2018-10-30,2018-11,2018-11-30,2023-01-01,ESTIMATED,2023-01-01,2023-01-01,ESTIMATED,2023-01-01,,INTERVENTIONAL,,,QUILT-3.034: Non-Myeloablative TCRa/b Deplete Haplo HSCT With Post ALT-803 for AML,QUILT-3.034: Multi-Center Trial of Non-Myeloablative TCRa/b Deplete Haploidentical Hematopoietic Cell Transplantation With Post HCT ALT-803 in High-Risk Myeloid Diseases,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Masonic Cancer Center, University of Minnesota",,1.0,,Sponsor halted study.,f,,,,t,t,f,,,f,,,,,,,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,OTHER,,,,,,,2023,0.0
NCT03520712,,2018-04-10,,,2024-09-23,2018-04-27,2018-05-11,ACTUAL,,,,,,,2024-09-23,2024-09-25,ACTUAL,2018-04-03,ACTUAL,2018-04-03,2024-09,2024-09-30,2024-08-07,ACTUAL,2024-08-07,2024-08-07,ACTUAL,2024-08-07,,INTERVENTIONAL,GENEr8-AAV5+,,Gene Therapy Study in Severe Hemophilia a Patients with Antibodies Against AAV5,"A Phase 1/2 Safety, Tolerability, and Efficacy Study of Valoctocogene Roxaparvovec, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia a Patients with Residual FVIII Levels ≤ 1 IU/dL and Pre-existing Antibodies Against AAV5",TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,BioMarin Pharmaceutical,,1.0,,Early rollover into long-term extension study,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,INDUSTRY,,,,,,,2024,0.0
NCT03790865,,2018-12-28,2021-01-21,,2021-02-08,2018-12-28,2019-01-02,ACTUAL,2021-02-08,2021-02-17,ACTUAL,,,,2021-02-08,2021-02-17,ACTUAL,2019-03-25,ACTUAL,2019-03-25,2021-02,2021-02-28,2020-05-25,ACTUAL,2020-05-25,2020-02-26,ACTUAL,2020-02-26,,INTERVENTIONAL,ZEPHYR,,Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome,"A Phase 2b/3 Study to Evaluate the Safety, Tolerability, and Effects of Livoletide (AZP-531), an Unacylated Ghrelin Analogue, on Food-related Behaviors in Patients With Prader-Willi Syndrome",TERMINATED,,PHASE2/PHASE3,158.0,ACTUAL,"Millendo Therapeutics, Inc.","The double-blind, placebo-controlled phase 2b study did not meet the primary endpoint or any of the secondary endpoints. Therefore, the Sponsor has decided to discontinue further development of livoletide.",3.0,,Livoletide did not result in a statistically significant improvement in hyperphagia and food-related behaviors,,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,INDUSTRY,,,,,,,2020,0.0
NCT03933761,,2019-04-02,,,2021-08-03,2019-04-29,2019-05-01,ACTUAL,,,,,,,2021-08-03,2021-08-10,ACTUAL,2019-07-29,ACTUAL,2019-07-29,2021-08,2021-08-31,2021-08-02,ACTUAL,2021-08-02,2021-08-02,ACTUAL,2021-08-02,,INTERVENTIONAL,PRECISE,,"Pamiparib in Fusion Positive, Reversion Negative High Grade Serous Ovarian Cancer or Carcinosarcoma With BRCA1/2 Gene Mutations If Progression on Substrate Poly ADP Ribose Polymerase Inhibitbor (PARPI) or Chemotherapy","A Phase II, Signal-Seeking Trial of the Clinical Benefit Rate Associated With Pamiparib in Subjects With Germline or Somatic BRCA1/2 High Grade Serous Ovarian Cancer or Carcinosarcoma Who Have Progressed on P-gp Substrate Chemotherapy or PARPi With the Presence of an ABCB1 Fusion and the Absence of a BRCA1/2 Reversion",WITHDRAWN,,PHASE2,0.0,ACTUAL,Australia New Zealand Gynaecological Oncology Group,,1.0,,No eligible patient identified after 18 evaluable patients underwent pre-screening over a 2 year period.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,OTHER,,,,,,,2021,0.0
NCT04708418,,2021-01-13,,,2024-09-24,2021-01-13,2021-01-14,ACTUAL,,,,,,,2024-09-24,2024-09-25,ACTUAL,2021-10-15,ACTUAL,2021-10-15,2024-04,2024-04-30,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy in Patients With Operable Melanoma,Phase II Randomized Study of Neoadjuvant Pembrolizumab Alone or in Combination With CMP-001 in Patients With Operable Melanoma: Efficacy and Biomarker Study,SUSPENDED,,PHASE2,60.0,ESTIMATED,National Cancer Institute (NCI),,2.0,,Drug Supply Issues,f,,,,f,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.",2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,NIH,,,,,,,2024,0.0
NCT02273362,,2014-10-22,2021-08-12,,2024-02-29,2014-10-22,2014-10-24,ESTIMATED,2022-02-24,2022-02-25,ACTUAL,,,,2024-02-29,2024-03-26,ACTUAL,2014-11-24,ACTUAL,2014-11-24,2024-02,2024-02-29,2022-03-10,ACTUAL,2022-03-10,2020-02-11,ACTUAL,2020-02-11,,INTERVENTIONAL,,All patients registered and treated per protocol are included in this analysis.,Erlotinib Hydrochloride in Preventing Liver Cancer in Patients With Cirrhosis of the Liver,Pilot Study of EGFR Inhibition With Erlotinib in Cirrhosis to Inhibit Fibrogenesis and Prevent Hepatocellular Carcinoma,COMPLETED,,PHASE1/PHASE2,25.0,ACTUAL,National Cancer Institute (NCI),,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,NIH,,,,,,,2022,1.0
NCT03374488,,2017-12-11,2019-07-26,,2021-11-02,2017-12-11,2017-12-15,ACTUAL,2019-08-14,2019-08-28,ACTUAL,,,,2021-11-02,2021-11-30,ACTUAL,2017-12-22,ACTUAL,2017-12-22,2021-11,2021-11-30,2020-07-23,ACTUAL,2020-07-23,2018-07-27,ACTUAL,2018-07-27,,INTERVENTIONAL,,The Intention-to-Treat (ITT) population consisted of all randomized participants.,Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma,"A Phase 3 Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients Who Have Failed a First-Line Platinum-containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303)",COMPLETED,,PHASE3,84.0,ACTUAL,Incyte Corporation,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,INDUSTRY,,,,,,,2020,0.0
NCT03594175,,2018-07-10,2024-06-10,,2024-08-21,2018-07-10,2018-07-20,ACTUAL,2024-08-21,2024-08-23,ACTUAL,,,,2024-08-21,2024-08-23,ACTUAL,2020-02-12,ACTUAL,2020-02-12,2024-08,2024-08-31,2023-07-10,ACTUAL,2023-07-10,2023-06-08,ACTUAL,2023-06-08,,INTERVENTIONAL,READY1,Baseline was defined as the last non-missing value available before the first study drug administration.,Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality,"A Phase 3, Randomized, Double-Blind, Active and Placebo-Controlled Study on the Use of CUSA-081 for Dysfunctional Central Venous Access Devices (CVADs)",TERMINATED,,PHASE3,462.0,ACTUAL,Chiesi Farmaceutici S.p.A.,"13 June 2023, Chiesi issued an initial notification of enrolment hold to all participating study sites for READY 1 study.~05 July 2023, Chiesi issued a voluntary official notification of early termination of study recruitment to all participating sites, due to non-safety reasons. Patient recruitment was slow and completion of the study was not feasible in a reasonable timeframe. Early termination of the study was not expected to impact patient access to other necessary treatments.",3.0,,"Due to ongoing recruitment challenges globally, it is not possible to complete this study. The decision is not based on any reported changes in the safety profile or any concerns with the anticipated efficacy profile of the investigational product.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,INDUSTRY,,,,,,,2023,0.0
NCT02882126,,2016-08-24,,,2017-05-08,2016-08-24,2016-08-29,ESTIMATED,,,,,,,2017-05-08,2017-05-09,ACTUAL,2017-06,ESTIMATED,2017-06-30,2017-05,2017-05-31,2021-06,ESTIMATED,2021-06-30,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension,An Open-Label Extension Trial to Evaluate the Safety of Continued Therapy With Subcutaneous Remodulin® in Subjects With Pulmonary Arterial Hypertension Who Completed Study CVT-CV-003,WITHDRAWN,,PHASE4,0.0,ACTUAL,United Therapeutics,,1.0,,Business decision,f,,,,f,t,f,,,t,,,,,,,,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,INDUSTRY,,,,,,,2021,0.0
NCT03992846,,2019-06-18,2024-04-03,,2024-05-01,2019-06-18,2019-06-20,ACTUAL,2024-05-01,2024-05-29,ACTUAL,,,,2024-05-01,2024-05-29,ACTUAL,2019-06-13,ACTUAL,2019-06-13,2022-06,2022-06-30,2022-04-01,ACTUAL,2022-04-01,2021-10-18,ACTUAL,2021-10-18,,INTERVENTIONAL,,,Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.,"A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Assess the Efficacy and Safety of Linzagolix in Subjects With Moderate to Severe Endometriosis-associated Pain.",COMPLETED,,PHASE3,486.0,ACTUAL,"Kissei Pharmaceutical Co., Ltd.",,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,INDUSTRY,,,,,,,2022,1.0
NCT04668209,,2020-12-02,2023-06-09,,2023-10-16,2020-12-11,2020-12-16,ACTUAL,2023-07-21,2023-08-14,ACTUAL,,,,2023-10-16,2023-11-07,ACTUAL,2021-01-21,ACTUAL,2021-01-21,2022-11,2022-11-30,2022-10-19,ACTUAL,2022-10-19,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,CX4945,,Silmitasertib (CX-4945) in Patients With Severe Coronavirus Disease 2019 (COVID-19),"Phase II, Randomized, Investigator Initiated Trial to Evaluate Safety and to Explore Clinical Benefit of Silmitasertib (CX-4945) in Patients With Severe Coronavirus Disease 2019 (COVID-19)",TERMINATED,,PHASE2,31.0,ACTUAL,University of Arizona,"After 15 months of active enrollment and a lack of qualifying hospitalized COVID-19 patients, the Sponsor-Investigator, Marilyn Csete Glassberg, MD, decided to terminate recruitment before meeting the stated enrollment objectives.",2.0,,"After 15 months of active enrollment and a lack of qualifying hospitalized COVID-19 patients, the Sponsor-Investigator, Marilyn Csete Glassberg, MD, decided to terminate recruitment before meeting the stated enrollment objectives.",,,,,t,t,f,,,,,,,,,NO,Study results will be published on clinicaltrials.gov.,2024-10-17 00:42:13.771361,2024-10-17 00:42:13.771361,OTHER,,,,,,,2022,0.0
NCT04147260,,2019-10-30,2022-08-12,,2022-08-12,2019-10-30,2019-11-01,ACTUAL,2022-08-12,2023-07-17,ACTUAL,,,,2022-08-12,2023-07-17,ACTUAL,2019-11-06,ACTUAL,2019-11-06,2022-08,2022-08-31,2020-09-09,ACTUAL,2020-09-09,2020-09-09,ACTUAL,2020-09-09,,INTERVENTIONAL,,"Treated Set (TS): The TS included all subjects who were randomized and treated with at least 1 dose of investigational product (IP) (BI 730357, placebo, or Ciprofloxacin). The TS was used for safety analyses.",Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent Ciprofloxacin,"Partially-blind, Randomized, Parallel Group, Placebo and Active Comparator-controlled Phase I Clinical Trial to Evaluate the Photosensitivity Potential of BI 730357",COMPLETED,,PHASE1,85.0,ACTUAL,Boehringer Ingelheim,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/",2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,INDUSTRY,,,,,,,2020,1.0
NCT02142738,,2014-05-16,2017-04-14,,2022-05-17,2014-05-16,2014-05-20,ESTIMATED,2017-06-08,2017-07-07,ACTUAL,,,,2022-05-17,2022-06-13,ACTUAL,2014-08-25,ACTUAL,2014-08-25,2022-05,2022-05-31,2021-05-27,ACTUAL,2021-05-27,2016-05-09,ACTUAL,2016-05-09,,INTERVENTIONAL,,,Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024),A Randomized Open-Label Phase III Trial of Pembrolizumab Versus Platinum Based Chemotherapy in 1L Subjects With PD-L1 Strong Metastatic Non-Small Cell Lung Cancer,COMPLETED,,PHASE3,305.0,ACTUAL,Merck Sharp & Dohme LLC,,6.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,INDUSTRY,,,,,,,2021,1.0
NCT03323151,,2017-10-16,2023-08-30,,2024-01-16,2017-10-23,2017-10-26,ACTUAL,2024-01-05,2024-01-08,ACTUAL,,,,2024-01-16,2024-01-18,ACTUAL,2018-08-13,ACTUAL,2018-08-13,2024-01,2024-01-31,2023-09-07,ACTUAL,2023-09-07,2022-09-22,ACTUAL,2022-09-22,,INTERVENTIONAL,PrE0404,Patients with mantle cell lymphoma (MCL) that has relapsed (come back) or refractory (progressed on treatment) will receive ixazomib and ibrutinib.~Ibrutinib has been approved by the Food and Drug Administration (FDA) as treatment for patients with mantle cell lymphoma who have received at least one prior therapy.~Ixazomib is in a class of medications called proteasome inhibitors. It may help to slow down the growth of cancer or may cause cancer cells to die.,A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma,A Phase I/II Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma,COMPLETED,,PHASE1/PHASE2,43.0,ACTUAL,"PrECOG, LLC.",,3.0,,,f,,,,t,t,f,,,f,,,,,,NO,Data is proprietary.,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,OTHER,,,,,,,2023,0.0
NCT05418777,,2022-06-09,2023-11-08,,2023-11-08,2022-06-09,2022-06-14,ACTUAL,2023-11-08,2023-11-29,ACTUAL,,,,2023-11-08,2023-11-29,ACTUAL,2022-09-28,ACTUAL,2022-09-28,2023-11,2023-11-30,2022-12-19,ACTUAL,2022-12-19,2022-12-19,ACTUAL,2022-12-19,,INTERVENTIONAL,,No participants were enrolled and randomized to the placebo arm,Treatment of Pneumocystis in COPD (the TOPIC Study),Treatment of Pneumocystis in COPD (the TOPIC Study),TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,William Beaumont Hospitals,Study was terminated due to high screen failure rate leading to low enrollment,2.0,,lack of enrollment,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,OTHER,,,,,,,2022,0.0
NCT04039503,,2019-07-30,2021-12-12,,2021-12-12,2019-07-30,2019-07-31,ACTUAL,2021-12-12,2022-01-12,ACTUAL,,,,2021-12-12,2022-01-12,ACTUAL,2019-08-30,ACTUAL,2019-08-30,2021-12-01,2021-12-01,2021-01-13,ACTUAL,2021-01-13,2020-12-22,ACTUAL,2020-12-22,,INTERVENTIONAL,SURPASS-5,All randomized participants.,A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin,"Randomized, Phase 3, Double-blind Trial Comparing the Effect of the Addition of Tirzepatide Versus Placebo in Patients With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin",COMPLETED,,PHASE3,475.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,INDUSTRY,,,,,,,2021,1.0
NCT04908683,,2021-05-27,2023-12-21,,2024-02-07,2021-05-27,2021-06-01,ACTUAL,2024-02-07,2024-02-08,ACTUAL,,,,2024-02-07,2024-02-08,ACTUAL,2021-07-21,ACTUAL,2021-07-21,2024-02,2024-02-29,2023-07-21,ACTUAL,2023-07-21,2023-07-21,ACTUAL,2023-07-21,,INTERVENTIONAL,EVERGREEN,"Baseline characteristics data were analyzed on full analysis set (FAS) which included all participants with a documented vaccine administration, regardless of the occurrence of protocol deviations.",A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older,"A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older",COMPLETED,,PHASE3,25236.0,ACTUAL,Janssen Vaccines & Prevention B.V.,,2.0,,,f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,INDUSTRY,,,,,,,2023,1.0
NCT04305236,,2020-03-09,2022-08-24,,2023-05-09,2020-03-09,2020-03-12,ACTUAL,2023-02-02,2023-03-03,ACTUAL,,,,2023-05-09,2023-06-06,ACTUAL,2020-07-23,ACTUAL,2020-07-23,2023-05,2023-05-31,2022-02-16,ACTUAL,2022-02-16,2022-02-16,ACTUAL,2022-02-16,,INTERVENTIONAL,,,Neo-Adjuvant Abemaciclib With Fulvestrant in Patients With ER/PR +HER Negative Breast Cancer,A Phase II Open Label Trial of Neo-Adjuvant Abemaciclib With Fulvestrant in Patients Who Develop Localized Recurrence While on Adjuvant Endocrine Therapy With Molecular Evidence of Endocrine Resistance,TERMINATED,,PHASE2,1.0,ACTUAL,"University of California, Irvine",Early study termination and depleted funding lead to the small number of patients enrolled onto the study. This also contributed to the inability to analyze the primary and secondary objectives.,1.0,,Halted due to study funding,f,,,,t,t,f,,,,,,,,,,,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,OTHER,,,,,,,2022,0.0
NCT05286853,,2022-02-24,,,2024-09-23,2022-03-09,2022-03-18,ACTUAL,,,,,,,2024-09-23,2024-09-25,ACTUAL,2024-07-17,ACTUAL,2024-07-17,2024-07,2024-07-31,2024-09-03,ACTUAL,2024-09-03,2024-09-03,ACTUAL,2024-09-03,,INTERVENTIONAL,,,A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease,A Phase 3 Randomized Controlled Study of REACT in Participants With Type 2 Diabetes and Chronic Kidney Disease (REGEN-016),WITHDRAWN,,PHASE3,0.0,ACTUAL,Prokidney,,2.0,,Rilparencel is eligible for initial FDA/ RMAT approval pathway upon successful completion Phase3 REGEN006 (PROACT1) trial. Discontinued Phase3 REGEN016 (PROACT2) focused on enrollment outside the US and is not required for initial US registration.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2024,0.0
NCT04591002,,2020-09-08,,,2023-05-11,2020-10-15,2020-10-19,ACTUAL,,,,,,,2023-05-11,2023-05-12,ACTUAL,2020-10-07,ACTUAL,2020-10-07,2023-05,2023-05-31,2020-10-30,ACTUAL,2020-10-30,2020-10-07,ACTUAL,2020-10-07,,INTERVENTIONAL,,,Osimertinib to Suppress the Progression of GGN(EGFR Mutation-positive),"A Phase II, Open Label, Randomized Study of Osimertinib to Suppress the Progression of Remaining Ground-glass Opacity Nodule (GGN) in Other Lobes After Curative Resection for Actionable EGFR Mutation-positive Stage I Lung Adenocarcinoma",WITHDRAWN,,PHASE2,0.0,ACTUAL,Samsung Medical Center,,2.0,,"Further consultation is required, we plan to submit it again as a new project and proceed.",f,,,,f,f,f,,,t,,,,,,,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,OTHER,,,,,,,2020,0.0
NCT05118620,,2021-10-20,,,2022-05-31,2021-11-01,2021-11-12,ACTUAL,,,,,,,2022-05-31,2022-06-03,ACTUAL,2021-12-09,ACTUAL,2021-12-09,2022-05,2022-05-31,2022-05-31,ACTUAL,2022-05-31,2022-05-31,ACTUAL,2022-05-31,,INTERVENTIONAL,,,Pericapsular Nerve Group Block (PENG) for Hip Surgery,"Pericapsular Nerve Group Block (PENG): A Randomized, Triple-Masked, Placebo-Controlled Clinical Trial",WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of California, San Diego",,2.0,,Lack of staff to enroll,f,,,,f,t,f,,,t,,,,,,UNDECIDED,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,OTHER,,,,,,,2022,0.0
NCT04530838,,2020-08-25,2023-03-30,,2023-03-30,2020-08-25,2020-08-28,ACTUAL,2023-03-30,2023-04-21,ACTUAL,,,,2023-03-30,2023-04-21,ACTUAL,2020-09-16,ACTUAL,2020-09-16,2023-03,2023-03-31,2022-04-02,ACTUAL,2022-04-02,2022-04-02,ACTUAL,2022-04-02,,INTERVENTIONAL,,Safety population included all the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any vaccination.,20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants,"A PHASE 3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY UNBLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY JAPANESE INFANTS",COMPLETED,,PHASE3,668.0,ACTUAL,Pfizer,,3.0,,,f,,,,t,t,f,,,t,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2022,1.0
NCT03283046,,2017-09-12,,,2017-09-18,2017-09-13,2017-09-14,ACTUAL,,,,,,,2017-09-18,2017-09-20,ACTUAL,2017-10,ESTIMATED,2017-10-31,2017-09,2017-09-30,2020-10,ESTIMATED,2020-10-31,2020-10,ESTIMATED,2020-10-31,,INTERVENTIONAL,,,Study of Lenalidomide/Dexamethasone With Nivolumab and Ipilimumab in Patients With Newly Diagnosed Multiple Myeloma,Phase 1 Study of Lenalidomide/Dexamethasone With Nivolumab and Ipilimumab in Patients With Newly Diagnosed Multiple Myeloma,WITHDRAWN,,PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Similar to another study.,f,,,,f,t,f,,,,,,,,,,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,OTHER,,,,,,,2020,0.0
NCT05076877,,2021-09-17,,,2022-06-22,2021-10-12,2021-10-13,ACTUAL,,,,,,,2022-06-22,2022-06-27,ACTUAL,2021-09-17,ACTUAL,2021-09-17,2022-06,2022-06-30,2022-02-10,ACTUAL,2022-02-10,2022-02-10,ACTUAL,2022-02-10,,INTERVENTIONAL,,,A Study of Lazertinib (JNJ-73841937) in Healthy Participants,"A Phase 1, Open-label, Study in Healthy Participants to Evaluate the Effect of Steady State Concentrations of Lazertinib (JNJ-73841937) on the Single-dose Pharmacokinetics of Probe Substrates (Midazolam, Rosuvastatin, and Metformin)",COMPLETED,,PHASE1,20.0,ACTUAL,"Janssen Research & Development, LLC",,1.0,,,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2022,0.0
NCT03389685,,2017-12-26,,,2024-04-12,2017-12-26,2018-01-03,ACTUAL,,,,,,,2024-04-12,2024-04-15,ACTUAL,2018-09-09,ACTUAL,2018-09-09,2024-04,2024-04-30,2024-02,ESTIMATED,2024-02-29,2024-02,ESTIMATED,2024-02-29,,INTERVENTIONAL,,,Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury,Can Platelet Rich Plasma Reduce the Level of Pro-Inflammatory Synovial Fluid Biomarkers Following an Anterior Cruciate Ligament Tear,WITHDRAWN,,PHASE2,0.0,ACTUAL,NYU Langone Health,,2.0,,"COVID-19, Lack of Funding",f,,,,f,t,f,,,f,,,,,,,,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,OTHER,,,,,,,2024,0.0
NCT01004978,,2009-10-29,2023-01-19,,2023-12-06,2009-10-29,2009-10-30,ESTIMATED,2023-01-19,2023-02-17,ACTUAL,,,,2023-12-06,2024-01-03,ACTUAL,2009-10-28,ACTUAL,2009-10-28,2023-11,2023-11-30,2022-12-21,ACTUAL,2022-12-21,2021-02-11,ACTUAL,2021-02-11,,INTERVENTIONAL,,All randomized patients,Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery,"A Phase III Randomized, Double-Blind Trial of Chemoembolization With or Without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients With and Without Vascular Invasion",COMPLETED,,PHASE3,235.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,NIH,,,,,,,2022,1.0
NCT05758818,,2023-01-29,,,2023-08-04,2023-03-06,2023-03-07,ACTUAL,,,,,,,2023-08-04,2023-08-08,ACTUAL,2023-04-17,ACTUAL,2023-04-17,2023-08,2023-08-31,2023-06-08,ACTUAL,2023-06-08,2023-06-08,ACTUAL,2023-06-08,,INTERVENTIONAL,,,A Study of Milademetan Administration on Cardiac Repolarization in Healthy Subjects,"A Randomized, Positive and Placebo-Controlled Trial to Evaluate the Effects of Milademetan Administration on Cardiac Repolarization in Healthy Subjects",TERMINATED,,PHASE1,6.0,ACTUAL,Rain Oncology Inc,,3.0,,sponsor decision,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2023,0.0
NCT02532257,,2015-08-21,2024-07-17,,2024-09-18,2015-08-24,2015-08-25,ESTIMATED,2024-09-18,2024-09-24,ACTUAL,,,,2024-09-18,2024-09-24,ACTUAL,2016-04-11,ACTUAL,2016-04-11,2024-09,2024-09-30,2023-08-15,ACTUAL,2023-08-15,2023-08-15,ACTUAL,2023-08-15,,INTERVENTIONAL,,,"Ibrutinib in Combination With Rituximab and Lenalidomide in Treating Patients With Previously Untreated, Stage II-IV Follicular Lymphoma or Marginal Zone Lymphoma","An Open Label, Phase 2 Study of Ibrutinib in Combination With Rituximab and Lenalidomide in Previously Untreated Subjects With Follicular Lymphoma and Marginal Zone Lymphoma",COMPLETED,,PHASE2,48.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,OTHER,,,,,,,2023,1.0
NCT03671720,,2018-09-13,,,2024-02-05,2018-09-13,2018-09-14,ACTUAL,,,,,,,2024-02-05,2024-02-07,ACTUAL,2018-09-11,ACTUAL,2018-09-11,2024-02,2024-02-29,2022-12-30,ACTUAL,2022-12-30,2021-12-30,ACTUAL,2021-12-30,,INTERVENTIONAL,,,Personalized Vaccine Generated by Autologous Dendritic Cells Pulsed With Autologous Whole Tumor Cell Lysate Treat Advanced Solid Tumor Patients With High Tumor Mutation Burden,Personalized Vaccine Generated by Autologous Dendritic Cells Pulsed With Autologous Whole Tumor Cell Lysate Treat Advanced Solid Tumor Patients With High Tumor Mutation Burden,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Capital Medical University,,1.0,,No participants enrolled,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,OTHER,,,,,,,2022,0.0
NCT02374424,,2015-02-17,,,2022-06-01,2015-02-26,2015-02-27,ESTIMATED,,,,,,,2022-06-01,2022-06-06,ACTUAL,2014-11-05,ACTUAL,2014-11-05,2022-06,2022-06-30,2020-06-23,ACTUAL,2020-06-23,2018-02,ACTUAL,2018-02-28,,INTERVENTIONAL,GIOTTO,,Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory DLBCL Patients,Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) Patients Before High-Dose Chemotherapy BEAM With Autologous Stem Cell Transplantation (ASCT),TERMINATED,,PHASE2,29.0,ACTUAL,Fondazione Italiana Linfomi - ETS,,1.0,,"Interim analysis planned as per protocol didn't provide positive outcome therefore enrollment was not reopened. However, the enrolled patients concluded therapy and continued into the follow-up phase. The study was closed only after LVLP.",f,,,,f,,,,,,,,,,,NO,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,OTHER,,,,,,,2020,0.0
NCT04697290,,2021-01-05,,,2022-01-29,2021-01-05,2021-01-06,ACTUAL,,,,,,,2022-01-29,2022-02-14,ACTUAL,2022-03-10,ESTIMATED,2022-03-10,2022-01,2022-01-31,2023-06-10,ESTIMATED,2023-06-10,2023-03-10,ESTIMATED,2023-03-10,,INTERVENTIONAL,,,CD19/CD20 Dual-CAR-T in B-cell Non-Hodgkin's Lymphoma Patients.,A Study of CD19/CD20 Dual CAR-T Cells in the Treatment of Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma(B-NHL),SUSPENDED,,EARLY_PHASE1,12.0,ESTIMATED,Beijing Tsinghua Chang Gung Hospital,,1.0,,Plan adjustment,f,,,,,f,f,,,,,,,,,,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,OTHER,,,,,,,2023,0.0
NCT03508804,,2016-06-15,,,2018-05-15,2018-04-17,2018-04-26,ACTUAL,,,,,,,2018-05-15,2018-05-16,ACTUAL,2020-12,ESTIMATED,2020-12-31,2018-05,2018-05-31,2022-12,ESTIMATED,2022-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Lidocaine-Prilocaine Cream in Conjunction With Paracervical Block for Pain With Abortion,Lidocaine-Prilocaine Cream in Conjunction With Lidocaine Paracervical Block for Pain With First-Trimester Abortion: A Double-Blind Randomized Controlled Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,Stanford University,,2.0,,Lack of funding.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,OTHER,,,,,,,2022,0.0
NCT05219604,,2022-01-18,,,2024-02-13,2022-01-20,2022-02-02,ACTUAL,,,,,,,2024-02-13,2024-02-14,ACTUAL,2022-03-15,ACTUAL,2022-03-15,2024-02,2024-02-29,2022-10-04,ACTUAL,2022-10-04,2022-10-04,ACTUAL,2022-10-04,,INTERVENTIONAL,,,Central Nervous System Effects Following Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling,The Magnitude and Duration of the Central Nervous System Effects Following Intravenous Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling,TERMINATED,,PHASE4,3.0,ACTUAL,Dent Neuroscience Research Center,,,,Institution decision,f,,,,,t,f,,,f,,,,,,,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,OTHER,,,,,,,2022,0.0
NCT03902938,,2019-03-18,,,2022-08-10,2019-04-02,2019-04-04,ACTUAL,,,,,,,2022-08-10,2022-08-12,ACTUAL,2018-10-02,ACTUAL,2018-10-02,2022-08,2022-08-31,2022-07-01,ACTUAL,2022-07-01,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,,,"Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial","Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial",WITHDRAWN,,PHASE4,0.0,ACTUAL,Ascension South East Michigan,,2.0,,The trial was stopped as the benefit was challenging to determine in the preliminary usage.,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,OTHER,,,,,,,2022,0.0
NCT04070157,,2019-07-02,,,2022-03-11,2019-08-23,2019-08-28,ACTUAL,,,,,,,2022-03-11,2022-03-14,ACTUAL,2019-08-02,ACTUAL,2019-08-02,2022-03,2022-03-31,2022-10-31,ESTIMATED,2022-10-31,2022-10-31,ESTIMATED,2022-10-31,,INTERVENTIONAL,TAPER,,"Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal","A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety and Effectiveness of LUCEMYRA in the Treatment of Opioid Withdrawal During an Opioid Taper in Subjects With Chronic Non-Cancer Pain",SUSPENDED,,PHASE2,60.0,ESTIMATED,"USWM, LLC (dba US WorldMeds)",,2.0,,COVID pandemic and enrollment issues necessitating an adjustment to the study design.,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,INDUSTRY,,,,,,,2022,0.0
NCT04306393,,2020-03-10,,,2022-06-20,2020-03-10,2020-03-12,ACTUAL,,,,,,,2022-06-20,2022-06-22,ACTUAL,2020-03-21,ACTUAL,2020-03-21,2022-06,2022-06-30,2022-06-15,ACTUAL,2022-06-15,2021-12-21,ACTUAL,2021-12-21,,INTERVENTIONAL,NOSARSCOVID,,Nitric Oxide Gas Inhalation in Severe Acute Respiratory Syndrome in COVID-19,Nitric Oxide Gas Inhalation Therapy for Mechanically Ventilated Patients With Severe Acute Respiratory Syndrome Caused by SARS-CoV2: a Randomized Clinical Trial.,COMPLETED,,PHASE2,200.0,ACTUAL,Massachusetts General Hospital,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,OTHER,,,,,,,2022,1.0
NCT04402723,,2020-05-18,,,2022-11-28,2020-05-24,2020-05-27,ACTUAL,,,,,,,2022-11-28,2022-12-01,ACTUAL,2018-11-06,ACTUAL,2018-11-06,2022-11,2022-11-30,2022-02-09,ACTUAL,2022-02-09,2022-02-09,ACTUAL,2022-02-09,,INTERVENTIONAL,,,Combination of Donafenib and Cytarabine/Daunorubicin in Relapsed AML,A Dose-escalated Phase Ⅰ Trial to Assess the Tolerance and Pharmacokinetics of Combination of Donafenib and Cytarabine/Daunorubicin in Relapsed AML Patient,TERMINATED,,PHASE1,8.0,ACTUAL,"Suzhou Zelgen Biopharmaceuticals Co.,Ltd",,2.0,,Corporate policy adjustments,f,,,,t,f,f,,,,,,,,,,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,INDUSTRY,,,,,,,2022,0.0
NCT05568797,,2022-10-03,2024-02-16,,2024-09-09,2022-10-03,2022-10-06,ACTUAL,2024-02-16,2024-03-15,ACTUAL,,,,2024-09-09,2024-09-24,ACTUAL,2022-10-14,ACTUAL,2022-10-14,2024-09,2024-09-30,2023-07-17,ACTUAL,2023-07-17,2023-02-17,ACTUAL,2023-02-17,,INTERVENTIONAL,,,A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone or Co-administered With an Adjuvanted Vaccine Against Influenza in Adults Aged 65 Years and Above,"A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of an RSVPreF3 OA Investigational Vaccine When Co-administered With FLU aQIV (Inactivated Influenza Vaccine - Adjuvanted) in Adults Aged 65 Years and Above",COMPLETED,,PHASE3,1045.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,f,t,f,,,f,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf,YES,"GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf",2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2023,1.0
NCT03809234,,2019-01-14,,,2022-03-28,2019-01-15,2019-01-18,ACTUAL,,,,,,,2022-03-28,2022-04-07,ACTUAL,2019-05-20,ACTUAL,2019-05-20,2022-03,2022-03-31,2020-11-30,ACTUAL,2020-11-30,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,,,Pgp Transporter and CNS Biodistribution of Ondansetron in Healthy Volunteers,Effects of Pgp Transporter Inhibition on CNS Biodistribution of Ondansetron in Healthy Volunteers,TERMINATED,,PHASE1,14.0,ACTUAL,Washington University School of Medicine,,2.0,,Adverse effects related to study procedure (not study drug),f,,,,t,t,f,,,,,,,,,,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,OTHER,,,,,,,2020,0.0
NCT03668665,,2018-09-05,,,2019-03-12,2018-09-10,2018-09-12,ACTUAL,,,,,,,2019-03-12,2019-03-14,ACTUAL,2018-10,ESTIMATED,2018-10-31,2019-03,2019-03-31,2020-10,ESTIMATED,2020-10-31,2020-04,ESTIMATED,2020-04-30,,INTERVENTIONAL,Split Wound,,Influencing Wound Healing Through the Application of Hyaluronic Acid With Perfluorodecalin and Physalis Angulata Extract After Split Skin Removal From the Thigh - A Study in Split Wound Design,Influencing Wound Healing Through the Application of Hyaluronic Acid With Perfluorodecalin and Physalis Angulata Extract After Split Skin Removal From the Thigh - A Study in Split Wound Design,WITHDRAWN,,PHASE3,0.0,ACTUAL,RWTH Aachen University,,2.0,,no approval by CA,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,OTHER,,,,,,,2020,0.0
NCT03284853,,2017-08-29,2021-11-05,,2022-01-24,2017-09-13,2017-09-15,ACTUAL,2021-12-20,2022-01-19,ACTUAL,,,,2022-01-24,2022-01-31,ACTUAL,2017-09-05,ACTUAL,2017-09-05,2022-01,2022-01-31,2020-11-06,ACTUAL,2020-11-06,2020-11-06,ACTUAL,2020-11-06,,INTERVENTIONAL,,"436 participants were randomized; 220 to the Netarsudil/Latanoprost 0.02%/0.005% arm and 216 to the Ganfort arm.~From the total 436 participants, 6 were not included in the analysis due to serious GCP breaches (see Pre-Assignment Details for more information).",Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension,"A Prospective, Double-masked, Randomized, Multicenter, Active-controlled, Parallel-group, 6-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to GANFORT® (Bimatoprost 0.03% / Timolol 0.5%) Ophthalmic Solution in Subjects With Elevated Intraocular Pressure (MERCURY 3)",COMPLETED,,PHASE3,436.0,ACTUAL,Aerie Pharmaceuticals,,2.0,,,f,,,,,t,f,,,t,,,,,,,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2020,1.0
NCT04856917,,2021-04-20,2023-05-19,,2023-05-19,2021-04-20,2021-04-23,ACTUAL,2023-05-19,2023-06-15,ACTUAL,,,,2023-05-19,2023-06-15,ACTUAL,2021-05-15,ACTUAL,2021-05-15,2023-05,2023-05-31,2022-03-29,ACTUAL,2022-03-29,2022-02-01,ACTUAL,2022-02-01,,INTERVENTIONAL,,The Intent-to-Treat (ITT) Analysis Set included all randomized participants.,A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris,"A Phase 2, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris",COMPLETED,,PHASE2,123.0,ACTUAL,"AnaptysBio, Inc.",,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 12:23:29.332555,2024-10-16 12:23:29.332555,INDUSTRY,,,,,,,2022,1.0
NCT04716413,,2021-01-13,2023-06-29,,2023-06-29,2021-01-15,2021-01-20,ACTUAL,2023-06-29,2023-07-19,ACTUAL,,,,2023-06-29,2023-07-19,ACTUAL,2021-09-27,ACTUAL,2021-09-27,2023-06,2023-06-30,2022-11-18,ACTUAL,2022-11-18,2022-11-17,ACTUAL,2022-11-17,,INTERVENTIONAL,,"No participants were enrolled into the Control (Standard of Care) arm prior to study termination. As such, zero participants were identified in the corresponding categories for the Control (Standard of Care) arm.",Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment,Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment Who Are Undergoing Ambulatory Surgery- a Case Series,TERMINATED,,PHASE4,3.0,ACTUAL,Montefiore Medical Center,,2.0,,"Terminated early due to funding, lack of participants",f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,OTHER,,,,,,,2022,0.0
NCT03518086,,2018-05-04,2022-01-26,,2024-06-20,2018-05-04,2018-05-08,ACTUAL,2022-02-25,2022-02-28,ACTUAL,,,,2024-06-20,2024-07-03,ACTUAL,2018-06-18,ACTUAL,2018-06-18,2024-06,2024-06-30,2024-05-15,ACTUAL,2024-05-15,2021-01-21,ACTUAL,2021-01-21,,INTERVENTIONAL,,All randomized participants.,An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1),"A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)",COMPLETED,,PHASE3,1281.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2024,1.0
NCT02718755,,2016-03-16,,,2018-06-22,2016-03-18,2016-03-24,ESTIMATED,,,,,,,2018-06-22,2018-06-26,ACTUAL,2018-05,ESTIMATED,2018-05-31,2018-06,2018-06-30,2022-05,ESTIMATED,2022-05-31,2021-05,ESTIMATED,2021-05-31,,INTERVENTIONAL,,,"Phase II Study of Fludarabine, Cytarabine (ARA-C) and Erwinase IV in Patients With Relapsed or Refractory Hematologic Malignancies","Phase II Study of Fludarabine, Cytarabine (ARA-C) and Erwinase IV in Patients With Relapsed or Refractory Hematologic Malignancies",WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Problem with drug supply,f,,,,f,t,f,,,,,,,,,,,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,OTHER,,,,,,,2022,0.0
NCT01988493,,2013-11-01,2019-02-05,,2022-08-22,2013-11-13,2013-11-20,ESTIMATED,2019-05-29,2019-07-24,ACTUAL,,,,2022-08-22,2022-08-24,ACTUAL,2014-01-06,ACTUAL,2014-01-06,2022-08,2022-08-31,2020-12-03,ACTUAL,2020-12-03,2018-02-05,ACTUAL,2018-02-05,,INTERVENTIONAL,,The safety analysis set included all participants who had received any dose of the study medication.,"Efficacy, Safety, and Pharmacokinetic of MSC2156119J in Asian Participants With Hepatocellular Carcinoma","A Multicenter, Randomized, Phase Ib/II Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of MSC2156119J as Monotherapy Versus Sorafenib in Asian Subjects With MET+ Advanced Hepatocellular Carcinoma and Child-Pugh Class A Liver Function",COMPLETED,,PHASE1/PHASE2,117.0,ACTUAL,"Merck KGaA, Darmstadt, Germany",,5.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,INDUSTRY,,,,,,,2020,1.0
NCT06612255,,2024-09-23,,,2024-09-23,2024-09-23,2024-09-25,ACTUAL,,,,,,,2024-09-23,2024-09-25,ACTUAL,2024-06-03,ACTUAL,2024-06-03,2024-09,2024-09-30,2024-09,ESTIMATED,2024-09-30,2024-09,ESTIMATED,2024-09-30,,INTERVENTIONAL,,,A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Tablet in Healthy Adults,"A Phase 1, Single Part, Partially Randomised, Open-Label Study to Evaluate the Relative Bioavailability of a Taste-Masked Delafloxacin Powder for Oral Suspension With Oral Delafloxacin Tablet Reference in Healthy Subjects",SUSPENDED,,PHASE1,16.0,ESTIMATED,"Melinta Therapeutics, Inc.",,4.0,,Data assessment,f,,,,,t,f,,,,,,,,,,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2024,0.0
NCT02163694,,2014-05-19,2022-03-11,2020-04-01,2024-02-19,2014-06-12,2014-06-16,ESTIMATED,2022-03-11,2022-04-04,ACTUAL,2020-04-01,2020-04-06,ACTUAL,2024-02-19,2024-02-23,ACTUAL,2014-07-17,ACTUAL,2014-07-17,2023-02,2023-02-28,2024-01-25,ACTUAL,2024-01-25,2019-04-05,ACTUAL,2019-04-05,,INTERVENTIONAL,,ITT population: randomized participants who have been documented to have suspected deleterious or deleterious BRCA1/2 mutations by the sponsor core laboratory,"A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer","A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer",COMPLETED,,PHASE3,509.0,ACTUAL,AbbVie,,2.0,,,f,,,,t,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,INDUSTRY,,,,,,,2024,1.0
NCT04175132,,2019-11-12,,,2020-12-08,2019-11-21,2019-11-22,ACTUAL,,,,,,,2020-12-08,2020-12-09,ACTUAL,2019-11-12,ACTUAL,2019-11-12,2020-12,2020-12-31,2020-03-10,ACTUAL,2020-03-10,2020-03-03,ACTUAL,2020-03-03,,INTERVENTIONAL,,,Binding of Foliglurax to Regions in the Brain in Healthy Participants and in Patients With Parkinson's Disease (PD),"Interventional, Open-label, Positron Emission Tomography (PET) Study With [11C]-PXT012253 Investigating the Brain mGlu4 Receptor Occupancy, Safety, Tolerability and Pharmacokinetics of Foliglurax in Healthy Subjects and Patients With Parkinson's Disease",TERMINATED,,PHASE1,6.0,ACTUAL,H. Lundbeck A/S,,2.0,,New efficacy data from another study,f,,,,f,f,f,,,,,,,,,,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2020,0.0
NCT04814875,,2021-03-04,,,2024-02-13,2021-03-23,2021-03-24,ACTUAL,,,,,,,2024-02-13,2024-02-14,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2024-02,2024-02-29,2023-11-30,ACTUAL,2023-11-30,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,,,A Study to Evaluate the Combination of ATX-101 and Platinum-based Chemotherapy,"Phase 1b/2a Study Investigating ATX-101 in Combination With Platinum-based Chemotherapy in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer",TERMINATED,,PHASE1/PHASE2,16.0,ACTUAL,THERAPIM PTY LTD,,2.0,,"For technical reasons, it was decided by the sponsor to close the ongoing ovarian cancer study, AM ATX101-03, immediately.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,INDUSTRY,,,,,,,2023,0.0
NCT03512353,,2018-04-02,2020-12-14,,2020-12-14,2018-04-19,2018-04-30,ACTUAL,2020-12-14,2021-01-08,ACTUAL,,,,2020-12-14,2021-01-08,ACTUAL,2018-07-05,ACTUAL,2018-07-05,2020-12,2020-12-31,2020-01-16,ACTUAL,2020-01-16,2020-01-16,ACTUAL,2020-01-16,,INTERVENTIONAL,,"The full analysis set includes all enrolled participants who received at least 1 dose of any study treatment (ie, carfilzomib or dexamethasone).",A Study of Carfilzomib Plus Dexamethasone in Adults With Relapsed or Refractory Multiple Myeloma at US Community Oncology Centers,An Open-label Phase 2 Study of Carfilzomib Plus Dexamethasone To Assess Tolerability and Adherence in Subjects With Relapsed or Refractory Multiple Myeloma at US Community Oncology Centers,TERMINATED,,PHASE2,7.0,ACTUAL,Amgen,"Because of the limited sample size, no meaningful conclusions on the study objectives can be made.",1.0,,Sponsor Decision,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2020,0.0
NCT04858451,,2021-04-19,,,2024-04-08,2021-04-23,2021-04-26,ACTUAL,,,,,,,2024-04-08,2024-04-09,ACTUAL,2021-03-01,ACTUAL,2021-03-01,2024-04,2024-04-30,2023-02-08,ACTUAL,2023-02-08,2022-12-22,ACTUAL,2022-12-22,,INTERVENTIONAL,CORVIS,,COmmunity Patients at Risk of Viral Infections Including SARS-CoV-2,"Community Participants With COPD or Bronchiectasis and at Risk of Respiratory Viral Infections Including SARS-CoV-2: An Open-label, Multicentre Feasibility Study of an Inhaled Nitric Oxide Generating Solution (RESP301)",TERMINATED,,PHASE2,39.0,ACTUAL,Thirty Respiratory Limited,,1.0,,Study stopping criteria were met. A safety event has occurred which was classified as an SAE and was related to the study intervention.,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 02:59:18.525228,2024-10-16 02:59:18.525228,INDUSTRY,,,,,,,2023,0.0
NCT04412252,,2020-05-30,,,2020-07-29,2020-05-30,2020-06-02,ACTUAL,,,,,,,2020-07-29,2020-07-31,ACTUAL,2020-07-06,ESTIMATED,2020-07-06,2020-07,2020-07-31,2020-10-18,ESTIMATED,2020-10-18,2020-09-16,ESTIMATED,2020-09-16,,INTERVENTIONAL,,,Safety and Efficacy of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia Who Are Receiving Standard of Care Therapy,"A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY ASSESSING THE SAFETY AND EFFICACY OF TOFACITINIB IN HOSPITALIZED PARTICIPANTS WITH COVID-19 PNEUMONIA WHO ARE RECEIVING STANDARD OF CARE THERAPY",WITHDRAWN,,PHASE2,0.0,ACTUAL,Pfizer,,2.0,,"Due to the pursuit of other SARS-CoV-2-related research including alternative trials with tofacitinib, this trial was canceled prior to subject enrollment.",f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,INDUSTRY,,,,,,,2020,0.0
NCT04262193,,2020-02-06,,,2024-09-23,2020-02-07,2020-02-10,ACTUAL,,,,,,,2024-09-23,2024-09-25,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2024-09,2024-09-30,2024-07-30,ACTUAL,2024-07-30,2024-07-30,ACTUAL,2024-07-30,,INTERVENTIONAL,,,Dual-Orexin Antagonism As a Mechanism for Improving Sleep and Drug Abstinence in Opioid Use Disorder,Dual-Orexin Antagonism As a Mechanism for Improving Sleep and Drug Abstinence in Opioid Use Disorder,TERMINATED,,PHASE2,37.0,ACTUAL,Wayne State University,,2.0,,Did not meet enrollment goals.,f,,,,t,t,f,,,t,,,Electronic copies of publications will be deposited within 4 weeks of acceptance. Underlying primary data will be made publicly available as soon as possible (time frame to be determined).,De-identified data (still being processed) will be placed in the NSRR (National Sleep Research Resource) repository.,https://sleepdata.org/,YES,"This plan is under development. This project was funded under the NIH HEAL Initiative, which requires data sharing through a repository; IPD details are being determined.",2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,OTHER,,,,,,,2024,0.0
NCT03940586,,2019-05-06,2023-11-29,,2024-07-30,2019-05-06,2019-05-07,ACTUAL,2024-01-05,2024-01-30,ACTUAL,,,,2024-07-30,2024-08-22,ACTUAL,2019-08-08,ACTUAL,2019-08-08,2024-07,2024-07-31,2023-08-25,ACTUAL,2023-08-25,2023-01-04,ACTUAL,2023-01-04,,INTERVENTIONAL,,Treated Participants,Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030),"A Phase 2b Open-label, Single-arm Study to Evaluate Pharmacokinetics, Efficacy, Safety and Tolerability of Letermovir in Pediatric Participants From Birth to Less Than 18 Years of Age at Risk of Developing CMV Infection and/or Disease Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)",COMPLETED,,PHASE2,65.0,ACTUAL,Merck Sharp & Dohme LLC,,1.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,INDUSTRY,,,,,,,2023,1.0
NCT03764683,,2018-11-29,,,2021-02-18,2018-12-03,2018-12-05,ACTUAL,,,,,,,2021-02-18,2021-02-21,ACTUAL,2019-02-26,ACTUAL,2019-02-26,2021-02,2021-02-28,2021-01-06,ACTUAL,2021-01-06,2021-01-06,ACTUAL,2021-01-06,,INTERVENTIONAL,,,Suvorexant (Belsomra) for the Treatment of Bipolar Depression With Insomnia,A Double-Blind Sequential Parallel Study of Suvorexant (Belsomra) for the Treatment of Bipolar Depression With Insomnia,WITHDRAWN,,PHASE4,0.0,ACTUAL,Massachusetts General Hospital,,3.0,,Study was terminated due to COVID-19.,f,,,,f,t,f,,,t,,,,,,NO,There is no plan to share individual participant data with other researchers.,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,OTHER,,,,,,,2021,0.0
NCT04424290,,2020-06-08,2024-04-25,2023-07-11,2024-04-25,2020-06-08,2020-06-09,ACTUAL,2024-04-25,2024-05-22,ACTUAL,,2023-07-13,ACTUAL,2024-04-25,2024-05-22,ACTUAL,2020-06-12,ACTUAL,2020-06-12,2024-04,2024-04-30,2023-04-28,ACTUAL,2023-04-28,2023-04-28,ACTUAL,2023-04-28,,INTERVENTIONAL,HORNBILL,Treated set: all patients who were randomised and treated with at least one dose of study drug.,HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia,"A First-in Human Trial to Study Safety and Tolerability of Single Rising Intravitreal dOses (Open Label, Non-randomized, Uncontrolled) and in Addition the Early Biological Response of Multiple intravitReal Dosing (Single-masked, raNdomized, Sham-controlled) of BI 764524 in panretinaL Photocoagulation (PRP) Treated proLiferative Diabetic Retinopathy (PDR) Patients With Diabetic Macular Ischemia (DMI) - the HORNBILL Study",COMPLETED,,PHASE1/PHASE2,45.0,ACTUAL,Boehringer Ingelheim,,5.0,,,f,,,,t,t,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,INDUSTRY,,,,,,,2023,1.0
NCT04957212,,2021-06-22,2023-03-13,,2024-02-12,2021-06-30,2021-07-12,ACTUAL,2024-02-12,2024-07-26,ACTUAL,,,,2024-02-12,2024-07-26,ACTUAL,2018-08-11,ACTUAL,2018-08-11,2024-02,2024-02-29,2020-05-27,ACTUAL,2020-05-27,2020-05-27,ACTUAL,2020-05-27,,INTERVENTIONAL,,,Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer,"A Phase III, Randomized, Two-armed, Parallel, Triple-blind, Active-controlled, Equivalency Clinical Trial of Efficacy and Safety Pertuzumab® (CinnaGen Co.) Compared With Perjeta® (Originator Pertuzumab) in Neoadjuvant Treatment of HER2+ Breast Cancer",COMPLETED,,PHASE3,214.0,ACTUAL,Cinnagen,,2.0,,,f,,,,,f,f,,,f,,,,,,,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2020,1.0
NCT02657447,,2015-12-22,,,2019-01-08,2016-01-14,2016-01-15,ESTIMATED,,,,,,,2019-01-08,2019-01-10,ACTUAL,2017-12-19,ACTUAL,2017-12-19,2019-01,2019-01-31,2020-09,ESTIMATED,2020-09-30,2019-09,ESTIMATED,2019-09-30,,INTERVENTIONAL,,,Dosimetry Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-02),"A Phase 1, Open Label, Randomized Study to Assess Pharmacokinetics, Biodistribution and Radiation Dosimetry of Lutetium (177Lu) Lilotomab Satetraxetan (Betalutin®) Radioimmunotherapy in Patients With Relapsed Non-Hodgkin Lymphoma",WITHDRAWN,,PHASE1,0.0,ACTUAL,Nordic Nanovector,,2.0,,Study is no longer relevant,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,INDUSTRY,,,,,,,2020,0.0
NCT03890120,,2019-03-25,2023-11-06,,2023-11-06,2019-03-25,2019-03-26,ACTUAL,2023-11-06,2023-11-29,ACTUAL,,,,2023-11-06,2023-11-29,ACTUAL,2019-03-27,ACTUAL,2019-03-27,2023-11,2023-11-30,2022-12-23,ACTUAL,2022-12-23,2022-11-10,ACTUAL,2022-11-10,,INTERVENTIONAL,PRIMIS,Safety Analysis Set included all participants who took at least 1 dose of study drug.,Study of Cilofexor in Adults With Primary Sclerosing Cholangitis,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis",TERMINATED,,PHASE3,419.0,ACTUAL,Gilead Sciences,,4.0,,"Following recommendation of the external Data Monitoring Committee, after it reviewed the results of a planned interim futility analysis.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,INDUSTRY,,,,,,,2022,0.0
NCT04467840,,2020-07-09,2023-01-28,,2023-09-25,2020-07-09,2020-07-13,ACTUAL,2023-09-25,2023-10-19,ACTUAL,,,,2023-09-25,2023-10-19,ACTUAL,2020-08-21,ACTUAL,2020-08-21,2023-09,2023-09-30,2021-07-18,ACTUAL,2021-07-18,2021-07-18,ACTUAL,2021-07-18,,INTERVENTIONAL,,,"Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia","Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: a Randomized, Double-blind, Placebo-Controlled Phase 2/3 Study, in Adult Subjects Hospitalized With Severe SARS-CoV-2 Positive Pneumonia",COMPLETED,,PHASE2/PHASE3,475.0,ACTUAL,RedHill Biopharma Limited,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,INDUSTRY,,,,,,,2021,1.0
NCT04445090,,2020-06-22,,,2021-11-11,2020-06-22,2020-06-24,ACTUAL,,,,,,,2021-11-11,2021-11-12,ACTUAL,2020-07-21,ACTUAL,2020-07-21,2021-11,2021-11-30,2021-09-10,ACTUAL,2021-09-10,2021-09-10,ACTUAL,2021-09-10,,INTERVENTIONAL,,,A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood,"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1569912 in Healthy Male Subjects (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel-group Design) With an Additional Relative Bioavailability/ Food Effect Part (Open-label, Randomized, Three-way Crossover Design)",TERMINATED,,PHASE1,68.0,ACTUAL,Boehringer Ingelheim,,3.0,,Identification of potential mutagenic metabolite in human plasma,f,,,,,f,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2021,0.0
NCT01265030,,2010-12-06,2023-01-26,,2023-06-01,2010-12-21,2010-12-22,ESTIMATED,2023-06-01,2023-06-26,ACTUAL,,,,2023-06-01,2023-06-26,ACTUAL,2014-02,ACTUAL,2014-02-28,2023-06,2023-06-30,2021-12-22,ACTUAL,2021-12-22,2021-12-22,ACTUAL,2021-12-22,,INTERVENTIONAL,,,A Pilot Study Evaluating the Use of mTor Inhibitor Sirolimus in Children and Young Adults With Desmoid-Type Fibromatosis,A Pilot Study Evaluating the Use of mTor Inhibitor Sirolimus in Children and Young Adults With Desmoid-Type Fibromatosis,COMPLETED,,PHASE1/PHASE2,9.0,ACTUAL,MaineHealth,,1.0,,,f,,,,t,t,,,,t,,,,,,,,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,OTHER,,,,,,,2021,1.0
NCT03958630,,2019-05-21,2024-02-27,,2024-04-05,2019-05-21,2019-05-22,ACTUAL,2024-04-05,2024-05-01,ACTUAL,,,,2024-04-05,2024-05-01,ACTUAL,2019-07-03,ACTUAL,2019-07-03,2024-01,2024-01-31,2023-12-04,ACTUAL,2023-12-04,2021-05-27,ACTUAL,2021-05-27,,INTERVENTIONAL,,,PET Imaging of Neuroinflammation in Neurodegenerative Diseases Via a Novel Translocator Protein (TSPO) Radioligand,PET Imaging of Neuroinflammation in Neurodegenerative Diseases Via a Novel TSPO Radioligand,TERMINATED,,PHASE1,13.0,ACTUAL,National Institutes of Health Clinical Center (CC),Secondary outcomes were not analyzed because:~* No data for the disease specific uptake across neurodegenerative diseases~* No longitudinal data was collected because the protocol was terminated due to low recruitment,3.0,,PI closed the protocol due to low recruitment,f,,,,,t,f,,,,,,,,,,,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,NIH,,,,,,,2023,0.0
NCT04633226,,2020-11-11,2023-10-02,,2024-09-09,2020-11-11,2020-11-18,ACTUAL,2023-10-30,2024-04-15,ACTUAL,,,,2024-09-09,2024-09-24,ACTUAL,2021-02-10,ACTUAL,2021-02-10,2024-09,2024-09-30,2022-11-04,ACTUAL,2022-11-04,2022-11-04,ACTUAL,2022-11-04,,INTERVENTIONAL,PNEU-PED-KOR,,Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036),"A Phase 3, Single-Arm, Open-label Clinical Study to Evaluate the Safety and Immunogenicity of 4 Doses of V114 Administered to Healthy Infants in South Korea.",COMPLETED,,PHASE3,58.0,ACTUAL,Merck Sharp & Dohme LLC,,1.0,,,f,,,,f,f,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2022,1.0
NCT02939209,,2016-10-18,,,2022-11-04,2016-10-18,2016-10-19,ESTIMATED,,,,,,,2022-11-04,2022-11-08,ACTUAL,2017-04-20,ACTUAL,2017-04-20,2022-11,2022-11-30,2022-05-31,ACTUAL,2022-05-31,2022-05-31,ACTUAL,2022-05-31,,INTERVENTIONAL,,,Pre-emptive Opioid Treatment to Prevent Rebound Pain After Arthroscopic Rotator Cuff Repair and/or Acromioplasty Under General Anesthesia and Interscalene Block,Preventing Rebound Pain After Arthroscopic Rotator Cuff Repair and/or Acromioplasty Under General Anesthesia and Interscalene Block: A Randomized Controlled Trial of Pre-emptive Opioid Treatment Compared to Placebo,COMPLETED,,PHASE4,73.0,ACTUAL,Nova Scotia Health Authority,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,OTHER,,,,,,,2022,0.0
NCT04382170,,2020-04-25,,,2024-05-10,2020-05-06,2020-05-11,ACTUAL,,,,,,,2024-05-10,2024-05-13,ACTUAL,2020-06,ESTIMATED,2020-06-30,2024-05,2024-05-31,2021-06,ESTIMATED,2021-06-30,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,Dexmedetomidine Sublingual Film for the Management of Agitation in Delirium: Safety and Preliminary Efficacy,Dexmedetomidine Sublingual Film for the Management of Agitation in Delirium: Safety and Preliminary Efficacy,WITHDRAWN,,PHASE2,0.0,ACTUAL,Massachusetts General Hospital,,2.0,,The study sponsor decided not to perform this study.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,OTHER,,,,,,,2021,0.0
NCT05897372,,2023-05-31,,,2024-09-23,2023-05-31,2023-06-09,ACTUAL,,,,,,,2024-09-23,2024-09-25,ACTUAL,2023-08-01,ACTUAL,2023-08-01,2024-09,2024-09-30,2024-09-23,ACTUAL,2024-09-23,2024-09-23,ACTUAL,2024-09-23,,INTERVENTIONAL,WP3,,Feasibility of Aggressive Albuminuria Reduction in Biopsy-Proven Diabetic Nephropathy - a Pilot Study,Feasibility of Aggressive Albuminuria Reduction in Biopsy-Proven Diabetic Nephropathy - a Pilot Study,TERMINATED,,PHASE2,1.0,ACTUAL,Herlev Hospital,,2.0,,Slow recruitment,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,OTHER,,,,,,,2024,0.0
NCT03118817,,2017-03-20,,,2020-08-06,2017-04-16,2017-04-18,ACTUAL,,,,,,,2020-08-06,2020-08-10,ACTUAL,2017-05-19,ACTUAL,2017-05-19,2020-08,2020-08-31,2020-02-04,ACTUAL,2020-02-04,2020-02-04,ACTUAL,2020-02-04,,INTERVENTIONAL,,,"Expansion Study to Evaluate the Efficacy and Safety of HM95573 in BRAF, KRAS or NRAS Mutant Solid Cancers","A Single-arm, Open-label, Multi-center, Phase I Expansion Study Evaluating the Efficacy and Safety of HM95573 Monotherapy in Patients With BRAF, KRAS or NRAS Mutation-positive Solid Cancers",COMPLETED,,PHASE1,65.0,ACTUAL,Hanmi Pharmaceutical Company Limited,,1.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2020,1.0
NCT00556374,,2007-11-08,2015-10-06,2015-09-29,2023-07-19,2007-11-08,2007-11-12,ESTIMATED,2015-10-06,2015-11-06,ESTIMATED,2015-09-29,2015-10-07,ESTIMATED,2023-07-19,2023-07-27,ACTUAL,2006-12-18,ACTUAL,2006-12-18,2023-06,2023-06-30,2022-07-26,ACTUAL,2022-07-26,2014-10-07,ACTUAL,2014-10-07,,INTERVENTIONAL,,,Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy,"A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase 3 Study to Determine the Treatment Effect of Denosumab in Subjects With Non-Metastatic Breast Cancer Receiving Aromatase Inhibitor Therapy.",COMPLETED,,PHASE3,3420.0,ACTUAL,Amgen,,4.0,,,f,,,,t,,,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,INDUSTRY,,,,,,,2022,1.0
NCT04878055,,2021-04-30,2024-01-08,,2024-05-20,2021-05-06,2021-05-07,ACTUAL,2024-05-20,2024-06-13,ACTUAL,,,,2024-05-20,2024-06-13,ACTUAL,2021-02-14,ACTUAL,2021-02-14,2024-05,2024-05-31,2021-10-31,ACTUAL,2021-10-31,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,,"FAS Full Analysis Set: set which consisted of all randomized subjects who received at least one dose of the IMP. The FAS population was analyzed according to the intent-to-treat (ITT) principle, i.e. by treatment allocation regardless the occurrence of intercurrent events (treatment policy strategy).",Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia.,"A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study on the Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia",COMPLETED,,PHASE3,287.0,ACTUAL,Dompé Farmaceutici S.p.A,,2.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2021,1.0
NCT04020419,,2019-06-24,,,2023-10-18,2019-07-11,2019-07-16,ACTUAL,,,,,,,2023-10-18,2023-10-23,ACTUAL,2020-12-01,ACTUAL,2020-12-01,2023-10,2023-10-31,2023-05-24,ACTUAL,2023-05-24,2023-05-24,ACTUAL,2023-05-24,,INTERVENTIONAL,Pediaberry,,Natural Berry Extract Treatment of Hemangiomas,Natural Berry Extract Treatment of Hemangiomas,TERMINATED,,EARLY_PHASE1,12.0,ACTUAL,Indiana University,,2.0,,Study ending early due to program transferring to another site.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,OTHER,,,,,,,2023,0.0
NCT03790852,,2018-12-27,,,2024-03-18,2018-12-31,2019-01-02,ACTUAL,,,,,,,2024-03-18,2024-03-20,ACTUAL,2018-12-26,ACTUAL,2018-12-26,2022-11,2022-11-30,2022-06-09,ACTUAL,2022-06-09,2021-06-02,ACTUAL,2021-06-02,,INTERVENTIONAL,,,"Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO","A Phase 1/1b Open Label, Multi-center Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With Wet Age-Related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO)",TERMINATED,,PHASE1,121.0,ACTUAL,Kodiak Sciences Inc,,2.0,,All patients past planned primary endpoint; decision by Sponsor to wind down open-label follow-up activities.,f,,,,f,t,f,,,,,,,,,,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2022,0.0
NCT04683796,,2020-12-20,,,2023-10-18,2020-12-20,2020-12-24,ACTUAL,,,,,,,2023-10-18,2023-10-23,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2023-10,2023-10-31,2023-03-30,ACTUAL,2023-03-30,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,,,Comparison of Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Dry Eye Disease,Comparison of Treatment Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Moderate to Severe Dry Eye Disease: A Randomized Controlled Trial Protocol,COMPLETED,,PHASE3,96.0,ACTUAL,Mahidol University,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,Data will be available upon the specific request.,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,OTHER,,,,,,,2023,1.0
NCT03837457,,2019-02-08,,,2020-11-17,2019-02-08,2019-02-12,ACTUAL,,,,,,,2020-11-17,2020-11-19,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2020-11,2020-11-30,2020-07-27,ACTUAL,2020-07-27,2020-07-24,ACTUAL,2020-07-24,,INTERVENTIONAL,PRISM,,PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Mycosis Fungoides Who Have Completed the SOLAR Study,"PRISM: An Open-label, Multi-Center Extension Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) Following Systemic Treatment in Subjects With Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype, Who Have Completed the SOLAR Study",TERMINATED,,PHASE2,8.0,ACTUAL,"miRagen Therapeutics, Inc.",,1.0,,Study no longer needed because eligible subjects may receive treatment with cobomarsen in a crossover arm of the SOLAR clinical trial (NCT03713320),f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2020,0.0
NCT04086121,,2019-09-10,2022-04-27,,2022-06-28,2019-09-10,2019-09-11,ACTUAL,2022-04-27,2022-05-18,ACTUAL,,,,2022-06-28,2022-07-19,ACTUAL,2019-09-24,ACTUAL,2019-09-24,2022-06,2022-06-30,2022-02-23,ACTUAL,2022-02-23,2021-04-28,ACTUAL,2021-04-28,,INTERVENTIONAL,,Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.,A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032,An Open Label Extension Study to Assess the Long Term Safety of Treatment With BI 655130 Administered Subcutaneously in Adult Patients With Moderate to Severe Atopic Dermatitis,TERMINATED,,PHASE2,14.0,ACTUAL,Boehringer Ingelheim,The study was terminated due to sponsor decision. The planned treatment period of 4 years was not reached.,1.0,,Sponsor decision,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2022,0.0
NCT01610336,,2012-04-03,2021-03-12,,2021-03-12,2012-06-01,2012-06-04,ESTIMATED,2021-03-12,2021-04-08,ACTUAL,,,,2021-03-12,2021-04-08,ACTUAL,2012-04-05,ACTUAL,2012-04-05,2021-03,2021-03-31,2020-05-27,ACTUAL,2020-05-27,2016-06-10,ACTUAL,2016-06-10,,INTERVENTIONAL,,,"A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment","A Phase IB/II, Open Label, Multicenter Study of INC280 Administered Orally in Combination With Gefitinib in Adult Patients With EGFR Mutated, c-MET-amplified Non-small Cell Lung Cancer Who Have Progressed After EGFR Inhibitor Treatment",COMPLETED,,PHASE2,161.0,ACTUAL,Novartis,,11.0,,,f,,,,f,t,f,,,t,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,INDUSTRY,,,,,,,2020,1.0
NCT04066491,,2019-08-22,2022-05-16,,2023-10-26,2019-08-22,2019-08-26,ACTUAL,2022-05-16,2022-06-13,ACTUAL,,,,2023-10-26,2023-11-14,ACTUAL,2019-09-20,ACTUAL,2019-09-20,2023-10,2023-10-31,2022-11-10,ACTUAL,2022-11-10,2021-05-20,ACTUAL,2021-05-20,,INTERVENTIONAL,,,Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC,"A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) as First-line Treatment of Biliary Tract Cancer",TERMINATED,,PHASE2/PHASE3,309.0,ACTUAL,EMD Serono,Data collection and analysis of Pharmacokinetics and Immunogenicity were omitted and not conducted due to business reason.,3.0,,"Based on a review of data conducted by the Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this study as the study was unlikely to achieve the primary objective of overall survival.",f,,,,t,t,f,,,,,,Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union.,Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.,http://bit.ly/IPD21,YES,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21",2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,INDUSTRY,,,,,,,2022,0.0
NCT04939701,,2021-06-18,2024-05-22,,2024-08-21,2021-06-18,2021-06-25,ACTUAL,2024-07-11,2024-08-06,ACTUAL,,,,2024-08-21,2024-08-23,ACTUAL,2021-12-23,ACTUAL,2021-12-23,2024-08,2024-08-31,2023-06-01,ACTUAL,2023-06-01,2023-06-01,ACTUAL,2023-06-01,,INTERVENTIONAL,,Safety Analysis Set (SAF). All participants who took at least 1 dose of the investigational product (IP).,Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants,"A Phase 1/2 Open-label Study Investigating the Safety, Tolerability and Efficacy of ASP0739 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors Known to Express NY-ESO-1",TERMINATED,,PHASE1/PHASE2,16.0,ACTUAL,Astellas Pharma Inc,,3.0,,"The comprehensive assessment of other studies indicated the lack of significant monotherapy activity, therefore, team decided to terminate the study.",f,,,,f,t,f,,,,,,,,,NO,Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,INDUSTRY,,,,,,,2023,0.0
NCT04893551,,2021-05-17,,,2023-04-18,2021-05-17,2021-05-19,ACTUAL,,,,,,,2023-04-18,2023-04-20,ACTUAL,2021-02-25,ACTUAL,2021-02-25,2023-04,2023-04-30,2022-06-27,ACTUAL,2022-06-27,2022-06-27,ACTUAL,2022-06-27,,INTERVENTIONAL,,,"A Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Participants","Phase 1b, Multicentre, Multiple Ascending Dose, Safety, Pharmacokinetic, and Pharmacodynamic Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Patients",TERMINATED,,PHASE1,16.0,ACTUAL,BerGenBio ASA,,1.0,,"After completion of all planned dose levels in the dose escalation phase, the sponsor decision was not to continue with expanding the cohorts of any of the dose levels, using the existing study design.",f,,,,t,f,f,,,,,,Beginning 3 months and ending 5 years following article publication,"Proposal should be directed to HYPERLINK mailto:clinical@bergenbio.com clinical@bergenbio.com. To gain access, data requestors will need to sign a data access agreement.",,YES,"Individual participant data that underlie the results reported in the article, after deidentification \[text, tables, figures and appendices\].",2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2022,0.0
NCT04602494,,2020-10-20,2023-12-21,,2024-04-02,2020-10-20,2020-10-26,ACTUAL,2024-04-02,2024-04-04,ACTUAL,,,,2024-04-02,2024-04-04,ACTUAL,2020-12-18,ACTUAL,2020-12-18,2024-04,2024-04-30,2022-06-27,ACTUAL,2022-06-27,2022-06-27,ACTUAL,2022-06-27,,INTERVENTIONAL,Pilot,,Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents,Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents,TERMINATED,,PHASE4,5.0,ACTUAL,Massachusetts General Hospital,,3.0,,"The pilot study used apo-varenicline under temp FDA authorization. When varenicline was available an IND exemption was granted to enroll children, IRB approved a trial of varenicline in participants ages 16-25 June 27, 2022, the pilot was terminated",f,,,,t,t,f,,,t,,,Beginning 3 months and ending 5 years following article publication.,Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Data access agreement required.,,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices), and the study protocol, statistical analysis plan, analytic code, and informed consent form will be made available to researchers who provide a methodologically sound proposal beginning 3 months and ending 5 years following article publication to achieve aims in the approved proposal. Proposals should be directed to rschuster@mgh.harvard.edu. To gain access, data requestors will need to sign a data access agreement.",2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,OTHER,,,,,,,2022,0.0
NCT02999893,,2016-12-05,,,2021-12-10,2016-12-20,2016-12-21,ESTIMATED,,,,,,,2021-12-10,2021-12-13,ACTUAL,2017-04-11,ACTUAL,2017-04-11,2021-12,2021-12-31,2021-02-07,ACTUAL,2021-02-07,2020-10-16,ACTUAL,2020-10-16,,INTERVENTIONAL,APROC,,A Study of APR-246 in Oesophageal Cancer,"A phase1b/2 Study Evaluating the Efficacy of APR-246, a First-in-class Agent Targeting Mutant p53 in the Treatment of Platinum Resistant Advanced and Metastatic Oesophageal or Gastro-oesophageal Junction Cancers",TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,"Peter MacCallum Cancer Centre, Australia",,1.0,,Funding ceased,f,,,,t,f,f,,,,,,,,,,,2024-10-15 15:48:28.586643,2024-10-15 15:48:28.586643,OTHER,,,,,,,2021,0.0
NCT04026750,,2019-07-17,2021-02-11,,2021-03-09,2019-07-17,2019-07-19,ACTUAL,2021-03-09,2021-04-02,ACTUAL,,,,2021-03-09,2021-04-02,ACTUAL,2019-09-15,ACTUAL,2019-09-15,2021-03,2021-03-31,2020-02-16,ACTUAL,2020-02-16,2020-02-16,ACTUAL,2020-02-16,,INTERVENTIONAL,,,Insulin Tolerance Test Study in Patients With Type 1 Diabetes,"A Randomized, Double-Blind, Placebo-Controlled Insulin Tolerance Test Study to Assess the Safety, Tolerability, and Pharmacodynamics OF Pitolisant in Patients With Type 1 Diabetes",TERMINATED,,PHASE1,5.0,ACTUAL,High Point Clinical Trials Center,,2.0,,Based on scientific data collected during the trial and high screen fail rate.,f,,,,,t,f,,,,,,,,,NO,,2024-10-17 00:47:51.176899,2024-10-17 00:47:51.176899,INDUSTRY,,,,,,,2020,0.0
NCT03461458,,2018-02-13,,,2022-01-23,2018-03-08,2018-03-12,ACTUAL,,,,,,,2022-01-23,2022-01-25,ACTUAL,2018-10-17,ACTUAL,2018-10-17,2022-01,2022-01-31,2021-02-06,ACTUAL,2021-02-06,2021-02-06,ACTUAL,2021-02-06,,INTERVENTIONAL,,,"Autologous, Culture-Expanded Mesenchymal Stromal Cells for Degenerative Disc Disease","A Phase I Study Evaluating the Safety and Feasibility of Autologous, Culture-Expanded Adipose-Derived Mesenchymal Stromal Cells in Subjects With Painful Degenerative Disc Disease",TERMINATED,,PHASE1,1.0,ACTUAL,Mayo Clinic,,2.0,,Principal Investigator transition,f,,,,f,t,f,,,f,,,,,,,,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,OTHER,,,,,,,2021,0.0
NCT03662711,,2018-08-28,,,2022-12-23,2018-09-05,2018-09-07,ACTUAL,,,,,,,2022-12-23,2022-12-28,ACTUAL,2018-11-11,ACTUAL,2018-11-11,2022-12,2022-12-31,2022-10-26,ACTUAL,2022-10-26,2022-10-26,ACTUAL,2022-10-26,,INTERVENTIONAL,,,Inhaled Long-acting Bronchodilators With or Without Inhaled Glucocorticosteroids for Preventing Hospitalizations and Death in Elderly Patients With Chronic Obstructive Pulmonary Disease,Comparison of 1-year Treatment With Inhaled Long Acting Bronchodilators (LABD) Plus Inhaled Glucocorticosteroids (ICS) Versus LABD Without ICS on Re-hospitalizations and/or Death in Elderly Patients With Chronic Obstructive Pulmonary Disease (COPD) Recently Hospitalized Because of an Acute Exacerbation of COPD (ICS-Life Study).,TERMINATED,,PHASE4,843.0,ACTUAL,Università degli Studi di Ferrara,,2.0,,Contract terminated between AIFA and the Sponsor (University of Ferrara),f,,,,t,f,f,,,,,,,,,,,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,OTHER,,,,,,,2022,0.0
NCT04712110,,2021-01-14,2023-03-27,,2023-05-12,2021-01-14,2021-01-15,ACTUAL,2023-05-12,2023-06-06,ACTUAL,,,,2023-05-12,2023-06-06,ACTUAL,2021-02-12,ACTUAL,2021-02-12,2023-05,2023-05-31,2022-03-28,ACTUAL,2022-03-28,2022-03-28,ACTUAL,2022-03-28,,INTERVENTIONAL,,The safety analysis set included all participants who received at least 1 dose of the treatment.,A Study of TAK-019 in Healthy Japanese Adults (COVID-19),"A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TAK-019 by Intramuscular Injection in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)",COMPLETED,,PHASE1/PHASE2,200.0,ACTUAL,Takeda,,2.0,,,f,,,,f,t,f,,,t,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,INDUSTRY,,,,,,,2022,1.0
NCT05418803,,2022-06-09,,,2022-06-13,2022-06-09,2022-06-14,ACTUAL,,,,,,,2022-06-13,2022-06-16,ACTUAL,2020-01-28,ACTUAL,2020-01-28,2022-06,2022-06-30,2020-02-14,ACTUAL,2020-02-14,2020-02-14,ACTUAL,2020-02-14,,INTERVENTIONAL,,,BE Study of Two Formulations of Rivaroxaban 2.5 mg in Healthy Subjects,"An Open-label, Randomized, 2-sequence, 2-period, Fasted, Single Dose, Oral Administration, Crossover Study to Evaluate the Bioequivalence of YHP1807 Tablets 2.5 mg and YHR1901 Tablets 2.5 mg in Healthy Volunteers",COMPLETED,,PHASE1,34.0,ACTUAL,Yuhan Corporation,,2.0,,,f,,,,f,f,f,,,,,,Beginning 1 year and ending 5 years after all trial endpoints were assessed,Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to ejsong@yuhan.co.kr.,,YES,De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to ejsong@yuhan.co.kr.~A summary of the study results will be posted in the publicly accessible database (i.e. clinicaltrials.gov).,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,INDUSTRY,,,,,,,2020,1.0
NCT02613416,,2015-11-20,2022-10-28,,2024-08-20,2015-11-23,2015-11-24,ESTIMATED,2024-08-20,2024-08-23,ACTUAL,,,,2024-08-20,2024-08-23,ACTUAL,2015-11,,2015-11-30,2024-08,2024-08-31,2021-08-20,ACTUAL,2021-08-20,2021-08-20,ACTUAL,2021-08-20,,INTERVENTIONAL,Dmab,,Denosumab and MRI Breast Imaging,Phase II Correlative Study of Denosumab Effects on Tissue and Imaging Breast Biomarkers,COMPLETED,,PHASE2,42.0,ACTUAL,Stony Brook University,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,OTHER,,,,,,,2021,1.0
NCT03679624,,2018-09-14,2023-08-01,,2023-09-25,2018-09-19,2018-09-20,ACTUAL,2023-09-25,2023-10-23,ACTUAL,,,,2023-09-25,2023-10-23,ACTUAL,2020-07-30,ACTUAL,2020-07-30,2023-09,2023-09-30,2020-10-13,ACTUAL,2020-10-13,2020-09-15,ACTUAL,2020-09-15,,INTERVENTIONAL,,0 subjects were enrolled in Cohort B.,Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia,A Phase II Study of Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia,TERMINATED,,PHASE2,1.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,Low accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:00:11.523432,2024-10-15 02:00:11.523432,OTHER,,,,,,,2020,0.0
NCT00301457,,2006-03-09,,,2023-02-17,2006-03-09,2006-03-13,ESTIMATED,,,,,,,2023-02-17,2023-02-21,ACTUAL,2006-06,ACTUAL,2006-06-30,2023-02,2023-02-28,2022-04,ACTUAL,2022-04-30,2022-04,ACTUAL,2022-04-30,,INTERVENTIONAL,DATA,,Different Durations of Adjuvant Anastrozole Therapy After 2 to 3 Years Tamoxifen Therapy in Breast Cancer,"A Prospective Randomised, Open, Multicentre, Phase III Study to Assess Different Durations of Anastrozole Therapy After 2 to 3 Years Tamoxifen as Adjuvant Therapy in Postmenopausal Women With Breast Cancer.",COMPLETED,,PHASE3,1914.0,ACTUAL,Maastricht University Medical Center,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,OTHER,,,,,,,2022,1.0
NCT02379650,,2015-02-28,,,2016-08-10,2015-03-04,2015-03-05,ESTIMATED,,,,,,,2016-08-10,2016-08-12,ESTIMATED,2016-07,,2016-07-31,2016-08,2016-08-31,2021-07,ESTIMATED,2021-07-31,2019-07,ESTIMATED,2019-07-31,,INTERVENTIONAL,,,Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss,RCT Assessing Hydroxychloroquine for Unexplained Recurrent Pregnancy Loss,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Utah,,2.0,,Testing required by FDA for IND approval was too expensive to move forward with conduct of the study.,f,,,,t,,,,,,,,,,,,,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,OTHER,,,,,,,2021,0.0
NCT04763135,,2021-02-15,,,2023-06-07,2021-02-18,2021-02-21,ACTUAL,,,,,,,2023-06-07,2023-06-08,ACTUAL,2021-12-15,ACTUAL,2021-12-15,2023-06,2023-06-30,2021-12-17,ACTUAL,2021-12-17,2021-12-17,ACTUAL,2021-12-17,,INTERVENTIONAL,MIR-P,,Mirtazapine in Cancer-related Poly-symptomatology,What is the Effectiveness and Safety of Mirtazapine Versus Escitalopram in Alleviating Cancer-associated Poly-symptomatology (MIR-P)? A Mixed-method Randomized Controlled Trial Protocol,TERMINATED,,PHASE3,1.0,ACTUAL,Hospices Civils de Lyon,,2.0,,difficulties in recruiting,f,,,,f,f,f,,,,,,,,,,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,OTHER,,,,,,,2021,0.0
NCT04849858,,2021-04-16,,,2024-08-22,2021-04-16,2021-04-19,ACTUAL,,,,,,,2024-08-22,2024-08-23,ACTUAL,2019-05-20,ACTUAL,2019-05-20,2024-08,2024-08-31,2023-01-13,ACTUAL,2023-01-13,2023-01-13,ACTUAL,2023-01-13,,INTERVENTIONAL,,,Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures,Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures: A Quality Improvement Project in Post-operative Pain,TERMINATED,,PHASE3,13.0,ACTUAL,"University of California, Irvine",,3.0,,Low recruitment,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,OTHER,,,,,,,2023,0.0
NCT05076604,,2021-10-04,2024-06-01,,2024-07-16,2021-10-04,2021-10-13,ACTUAL,2024-07-16,2024-08-06,ACTUAL,,,,2024-07-16,2024-08-06,ACTUAL,2019-03-25,ACTUAL,2019-03-25,2024-07,2024-07-31,2023-08-01,ACTUAL,2023-08-01,2023-06-01,ACTUAL,2023-06-01,,INTERVENTIONAL,,,Effects of Microplegia on Transfusion Rates After Cardiac Surgery,Effects of Microplegia on Transfusion Rates After Cardiac Surgery: A Randomized Prospective Analysis,COMPLETED,,PHASE4,314.0,ACTUAL,Washington University School of Medicine,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,OTHER,,,,,,,2023,1.0
NCT05152459,,2021-11-26,,,2023-05-26,2021-11-26,2021-12-09,ACTUAL,,,,,,,2023-05-26,2023-05-31,ACTUAL,2023-05-01,ESTIMATED,2023-05-01,2023-05,2023-05-31,2024-12-15,ESTIMATED,2024-12-15,2024-12-15,ESTIMATED,2024-12-15,,INTERVENTIONAL,,,Tazemetostat in Combination With Umbralisib and Ublituximab for the Treatment Relapsed or Refractory Follicular Lymphoma,A Phase 1/2 Study of Tazemetostat With Umbralisib and Ublituximab in Patients With Relapsed/Refractory Follicular Lymphoma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,City of Hope Medical Center,,1.0,,Feasibility,,,,,t,t,f,,,f,,,,,,,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,OTHER,,,,,,,2024,0.0
NCT02793219,,2016-05-19,,,2017-10-26,2016-06-02,2016-06-08,ESTIMATED,,,,,,,2017-10-26,2017-10-30,ACTUAL,2016-12,ESTIMATED,2016-12-31,2017-10,2017-10-31,2021-07,ESTIMATED,2021-07-31,2018-07,ESTIMATED,2018-07-31,,INTERVENTIONAL,,,Provenge Followed by Docetaxel in Castration-Resistant Prostate Cancer,Provenge Followed by Docetaxel in Castration-Resistant Prostate Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,"The University of Texas Health Science Center, Houston",,1.0,,Dendreon was sold and new company decided not to fund study.,f,,,,t,,,,,,,,,,,NO,,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,OTHER,,,,,,,2021,0.0
NCT03110133,,2017-04-03,2022-04-25,,2022-09-06,2017-04-06,2017-04-12,ACTUAL,2022-06-10,2022-07-06,ACTUAL,,,,2022-09-06,2022-10-05,ACTUAL,2017-05-08,ACTUAL,2017-05-08,2022-09,2022-09-30,2020-06-18,ACTUAL,2020-06-18,2020-02-28,ACTUAL,2020-02-28,,INTERVENTIONAL,PRISM3,Modified Intent to Treat (mITT) population used,"Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff","A Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrence of Clostridium Difficile Infection",COMPLETED,,PHASE2,206.0,ACTUAL,Finch Research and Development LLC.,,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,INDUSTRY,,,,,,,2020,1.0
NCT02171429,,2014-06-20,2021-02-11,,2021-07-21,2014-06-23,2014-06-24,ESTIMATED,2021-02-11,2021-03-05,ACTUAL,,,,2021-07-21,2021-07-23,ACTUAL,2014-11-14,ACTUAL,2014-11-14,2021-07,2021-07-31,2020-05-25,ACTUAL,2020-05-25,2020-03-02,ACTUAL,2020-03-02,,INTERVENTIONAL,HIBISCUS II,"The overall number of baseline participants (716) represents the total number enrolled (358) in this study, GA28949 (NCT02171429), plus the total number enrolled (358) in a second study of identical design, GA28948 (NCT02163759). Some of the pre-specified secondary outcome measure comparisons were planned to be evaluated by pooling data from both studies; all etrolizumab versus adalimumab comparisons and one family of etrolizumab versus placebo comparisons were evaluated on pooled data.",A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors,"Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors",COMPLETED,,PHASE3,358.0,ACTUAL,Hoffmann-La Roche,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,INDUSTRY,,,,,,,2020,1.0
NCT03619655,,2018-08-03,,,2023-10-30,2018-08-03,2018-08-08,ACTUAL,,,,,,,2023-10-30,2023-10-31,ACTUAL,2019-11-15,ACTUAL,2019-11-15,2023-10,2023-10-31,2022-11-14,ACTUAL,2022-11-14,2022-11-14,ACTUAL,2022-11-14,,INTERVENTIONAL,,,Assessment of Multi-Modality Quantitative Imaging for Evaluation of Response of Metastatic Prostate Cancer to Therapy,Assessment of Multi-Modality Quantitative Imaging for Evaluation of Response of Metastatic Prostate Cancer to Therapy,TERMINATED,,PHASE1,3.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,3.0,,"Due to changing prostate cancer standard of care, the research question became obsolete as the target population for the study no longer existed. The study is deemed not clinically relevant.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,OTHER,,,,,,,2022,0.0
NCT02576977,,2015-10-14,2019-07-08,,2021-09-13,2015-10-14,2015-10-15,ESTIMATED,2019-07-08,2019-08-02,ACTUAL,,,,2021-09-13,2021-10-08,ACTUAL,2015-10-19,ACTUAL,2015-10-19,2021-09,2021-09-30,2020-07-16,ACTUAL,2020-07-16,2018-07-09,ACTUAL,2018-07-09,,INTERVENTIONAL,,The analysis population included all randomized participants.,Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK-3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (MK-3475-183/KEYNOTE-183),A Phase III Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (KEYNOTE 183),TERMINATED,,PHASE3,251.0,ACTUAL,Merck Sharp & Dohme LLC,The MK-3475-183 study was stopped/terminated early. Endpoint statistics may be biased due to the incomplete treatment and follow-up of participants after study termination,2.0,,The study was terminated early due to business reasons,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,INDUSTRY,,,,,,,2020,0.0
NCT05081375,,2020-01-16,,,2024-04-22,2021-10-04,2021-10-18,ACTUAL,,,,,,,2024-04-22,2024-04-24,ACTUAL,2019-12-16,ACTUAL,2019-12-16,2024-04,2024-04-30,2023-11-02,ACTUAL,2023-11-02,2023-11-02,ACTUAL,2023-11-02,,INTERVENTIONAL,,,Pre-operative Enoxaparin in the Surgical Management of Multi-trauma Patients Undergoing Orthopedic Surgical Procedures,"A Blinded, Controlled, Randomized Study of the Safety of Pre-operative Enoxaparin in the Surgical Management of Multi-trauma Patients Undergoing Orthopedic Surgical Procedures",TERMINATED,,PHASE4,6.0,ACTUAL,Valleywise Health,,2.0,,PI left the institution,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,OTHER,,,,,,,2023,0.0
NCT03151863,,2017-03-31,,,2021-07-20,2017-05-11,2017-05-12,ACTUAL,,,,,,,2021-07-20,2021-07-28,ACTUAL,2018-11-14,ACTUAL,2018-11-14,2021-07,2021-07-31,2021-06-08,ACTUAL,2021-06-08,2021-06-08,ACTUAL,2021-06-08,,INTERVENTIONAL,INDEX,,Intranasal Dexmedetomidine for Procedural Pain Management in Elderly Adults in Palliative Care,"Intranasal Dexmedetomidine for Procedural Pain Management in Elderly Adults in Palliative Care Setting: a Cross Over, Superiority, Double-blind, Controlled and Randomized Clinical Trial",TERMINATED,,PHASE3,33.0,ACTUAL,"University Hospital, Geneva",,2.0,,Lack of budget,f,,,,f,f,f,,,,,,,,,UNDECIDED,"In case of request for a systematic review/meta-analysis, IPD can be shared after publication.",2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,OTHER,,,,,,,2021,0.0
NCT04781647,,2021-02-22,2023-07-14,,2023-10-04,2021-03-02,2021-03-04,ACTUAL,2023-10-04,2023-10-06,ACTUAL,,,,2023-10-04,2023-10-06,ACTUAL,2021-02-18,ACTUAL,2021-02-18,2023-10,2023-10-31,2022-12-02,ACTUAL,2022-12-02,2022-12-02,ACTUAL,2022-12-02,,INTERVENTIONAL,,,A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection,"A Randomized Phase 2a, Multicenter, Open-label Study Evaluating ABI-H0731-Containing Regimens in Patients With Chronic Hepatitis B",TERMINATED,,PHASE2,54.0,ACTUAL,Assembly Biosciences,"Study ABI-H0731-203 was terminated early by the study Sponsor for strategic reasons to prioritize research and development efforts on finite and curative HBV therapies. As a result, not all subjects completed Week 48 and some outcome measures were impacted.",3.0,,Study ABI-H0731-203 was terminated early by the study Sponsor for strategic reasons to prioritize research and development efforts on finite and curative HBV therapies.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,INDUSTRY,,,,,,,2022,0.0
NCT03706274,,2018-10-11,,,2021-04-30,2018-10-11,2018-10-15,ACTUAL,,,,,,,2021-04-30,2021-05-05,ACTUAL,2020-01,ESTIMATED,2020-01-31,2021-04,2021-04-30,2022-12,ESTIMATED,2022-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,PROCLAIM-CX-188: A Trial to Find Safe and Active Doses of an Investigational Drug CX-188 for Patients With Solid Tumors,"A Phase 1, Open-Label, Dose-Ranging Study of the PD-1 Probody Therapeutic CX-188 in Adults With Recurrent or Metastatic Solid Tumors",WITHDRAWN,,PHASE1,0.0,ACTUAL,CytomX Therapeutics,,2.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,INDUSTRY,,,,,,,2022,0.0
NCT05123586,,2021-11-16,,,2024-07-10,2021-11-16,2021-11-17,ACTUAL,,,,,,,2024-07-10,2024-07-12,ACTUAL,2022-03-07,ACTUAL,2022-03-07,2024-07,2024-07-31,2023-12-29,ACTUAL,2023-12-29,2023-12-29,ACTUAL,2023-12-29,,INTERVENTIONAL,,,A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Two-Arm, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LY3361237 as a Treatment for Adults With At Least Moderately Active Systemic Lupus Erythematosus",TERMINATED,,PHASE2,85.0,ACTUAL,Eli Lilly and Company,,2.0,,Study terminated due to lack of efficacy,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,INDUSTRY,,,,,,,2023,0.0
NCT04744207,,2021-01-28,2023-05-26,,2024-03-06,2021-02-05,2021-02-08,ACTUAL,2024-03-06,2024-08-09,ACTUAL,,,,2024-03-06,2024-08-09,ACTUAL,2020-12-29,ACTUAL,2020-12-29,2024-03,2024-03-31,2022-06-15,ACTUAL,2022-06-15,2022-06-15,ACTUAL,2022-06-15,,INTERVENTIONAL,,,A Study to Investigate Safety of GS-248 and Efficacy on Raynauds' Phenomenon in Systemic Sclerosis,"A Phase II, Randomized, Multi-center, Placebo-controlled, Double-blind Study to Investigate the Safety of GS-248, and Efficacy on Raynaud's Phenomenon (RP) and Peripheral Vascular Blood Flow, in Subjects With Systemic Sclerosis (SSc)",COMPLETED,,PHASE2,94.0,ACTUAL,Gesynta Pharma AB,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,INDUSTRY,,,,,,,2022,1.0
NCT04903054,,2021-05-21,,,2023-03-20,2021-05-21,2021-05-26,ACTUAL,,,,,,,2023-03-20,2023-03-22,ACTUAL,2022-01-10,ACTUAL,2022-01-10,2023-03,2023-03-31,2022-09-22,ACTUAL,2022-09-22,2022-09-22,ACTUAL,2022-09-22,,INTERVENTIONAL,,,Selective CD28 Blockade in Renal Transplant Recipients,Selective CD28 Blockade With Lulizumab Compared to CNI Inhibition With Tacrolimus in Renal Transplant Recipients,WITHDRAWN,,PHASE2,0.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,Limited period of availability of a supply of the study drug and difficulties in enrollment,f,,,,t,t,f,,,,,,"On average, within 24 months after database lock for the trial.",Open access.,https://www.immport.org/home,YES,"The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.",2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,NIH,,,,,,,2022,0.0
NCT04299503,,2020-03-04,,,2022-01-06,2020-03-04,2020-03-06,ACTUAL,,,,,,,2022-01-06,2022-01-21,ACTUAL,2020-03-06,ACTUAL,2020-03-06,2022-01,2022-01-31,2022-12,ESTIMATED,2022-12-31,2022-03,ESTIMATED,2022-03-31,,INTERVENTIONAL,,,Topical Crisaborole in Patients With Alopecia Areata,Phase 2 Double Blind Randomized Placebo Controlled Trial of Topical Crisaborole in Patients With Mild-to-Moderate Alopecia Areata,WITHDRAWN,,PHASE2,0.0,ACTUAL,Tufts Medical Center,,2.0,,Unable to identify subjects to meet inclusion criteria,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,OTHER,,,,,,,2022,0.0
NCT03187080,,2017-06-01,2024-06-19,,2024-08-20,2017-06-13,2017-06-14,ACTUAL,2024-08-20,2024-08-23,ACTUAL,,,,2024-08-20,2024-08-23,ACTUAL,2017-10-19,ACTUAL,2017-10-19,2024-08,2024-08-31,2021-06-15,ACTUAL,2021-06-15,2021-06-15,ACTUAL,2021-06-15,,INTERVENTIONAL,,Study Terminated Early,Enhanced Recovery Strategies in Elective Breast Surgery,Evaluating the Use of Enhanced Recovery Strategies and Paravertebral Block in Elective Breast Reduction and Breast Augmentation,TERMINATED,,PHASE4,113.0,ACTUAL,"University of Wisconsin, Madison",Study terminated early and not powered for meaningful results.,8.0,,per Research Hold,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,OTHER,,,,,,,2021,0.0
NCT04816916,,2021-03-19,,,2022-07-26,2021-03-24,2021-03-25,ACTUAL,,,,,,,2022-07-26,2022-07-27,ACTUAL,2021-06-29,ACTUAL,2021-06-29,2022-07,2022-07-31,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,EMMPOWER,,Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy,"A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AXA1665 in Subjects With Liver Cirrhosis and Prior Overt Hepatic Encephalopathy (EMMPOWER)",TERMINATED,,PHASE2,12.0,ACTUAL,"Axcella Health, Inc",,2.0,,Sponsor is stopping the study to focus company resources on other development programs.,f,,,,t,t,f,,,,,,,,,,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,INDUSTRY,,,,,,,2022,0.0
NCT03786094,,2018-12-20,2023-09-19,,2023-10-30,2018-12-20,2018-12-24,ACTUAL,2023-10-30,2023-11-01,ACTUAL,,,,2023-10-30,2023-11-01,ACTUAL,2019-05-30,ACTUAL,2019-05-30,2023-10,2023-10-31,2021-10-19,ACTUAL,2021-10-19,2021-10-19,ACTUAL,2021-10-19,,INTERVENTIONAL,FORTRESS,Overall Population (2nd Line+),"Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer","An International, Phase 3, Multicenter, Randomized, Open- Label Trial Comparing Balixafortide in Combination With Eribulin Versus Eribulin Alone in Patients With HER2 Negative, Locally Recurrent or Metastatic Breast Cancer",TERMINATED,,PHASE3,432.0,ACTUAL,Spexis AG,The trial was halted early due to failure to meet the primary endpoint.,2.0,,The study was halted early due to failure to meet the primary endpoint.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,INDUSTRY,,,,,,,2021,0.0
NCT04159896,,2019-10-21,2024-04-25,,2024-07-14,2019-11-08,2019-11-12,ACTUAL,2024-07-14,2024-07-16,ACTUAL,,,,2024-07-14,2024-07-16,ACTUAL,2019-11-13,ACTUAL,2019-11-13,2024-07,2024-07-31,2022-03-01,ACTUAL,2022-03-01,2022-03-01,ACTUAL,2022-03-01,,INTERVENTIONAL,,"This is a single arm study with run-in phase. All participants, including the run-in phase, received same dose level, so the safety or efficacy will be analyzed in the total n=10 participants as a single group.",ESK981 and Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer,Phase II Multi-Center Trial of ESK981 in Combination With Nivolumab in Patients With Metastatic Castrate Resistant Prostate Cancer,TERMINATED,,PHASE2,10.0,ACTUAL,Barbara Ann Karmanos Cancer Institute,Early termination leading to small numbers of subjects analyzed.,1.0,,The study was closed to accrual on 3/1/21 due to safety concerns since 2 patients experienced CVA events.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,OTHER,,,,,,,2022,0.0
NCT04360551,,2020-04-21,2023-08-01,,2023-08-16,2020-04-22,2020-04-24,ACTUAL,2023-08-16,2023-08-21,ACTUAL,,,,2023-08-16,2023-08-21,ACTUAL,2020-07-01,ACTUAL,2020-07-01,2023-08,2023-08-31,2022-04-26,ACTUAL,2022-04-26,2022-04-26,ACTUAL,2022-04-26,,INTERVENTIONAL,,,Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients,"Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients",TERMINATED,,PHASE2,24.0,ACTUAL,University of Hawaii,"The number of individuals involved in the study was extremely small. The study was terminated early because the number of infections in the community substantially decreased.~As an outpatient study, the study only involved individuals with mild to moderate COVID-19 infection, as those severely ill with acute COVID-19 infections may have been hospitalized.",2.0,,Decrease in COVID-19 cases locally,f,,,,f,t,f,,,t,,,,,,YES,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,OTHER,,,,,,,2022,0.0
NCT04920383,,2021-06-03,,,2024-02-29,2021-06-03,2021-06-09,ACTUAL,,,,,,,2024-02-29,2024-03-01,ACTUAL,2021-06-22,ACTUAL,2021-06-22,2024-02,2024-02-29,2023-02-28,ACTUAL,2023-02-28,2022-11-08,ACTUAL,2022-11-08,,INTERVENTIONAL,NEON-2,,ALPN-202 With PD-1 Inhibition in Advanced Malignancies,An Open-label Study of ALPN-202 Combined With PD-1 Inhibition in Subjects With Advanced Malignancies (NEON-2),TERMINATED,,PHASE1,29.0,ACTUAL,"Alpine Immune Sciences, Inc.",,1.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,INDUSTRY,,,,,,,2023,0.0
NCT03654729,,2018-08-29,2021-08-31,,2021-11-19,2018-08-29,2018-08-31,ACTUAL,2021-11-19,2021-12-17,ACTUAL,,,,2021-11-19,2021-12-17,ACTUAL,2018-11-07,ACTUAL,2018-11-07,2021-11,2021-11-30,2020-08-31,ACTUAL,2020-08-31,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,POLAR-M,Safety analysis set consisting of all randomized patients who received at least one dose of IMP. Patients were analyzed according to the study treatment they actually received.,Preventive Treatment of Oxaliplatin Induced Peripheral Neuropathy in Metastatic Colorectal Cancer (POLAR-M),"A Phase 3, Double-blind, Multicenter, Placebo-controlled Study of PledOx Used on Top of Modified FOLFOX6 (5-FU/FA and Oxaliplatin) to Prevent Chemotherapy Induced Peripheral Neuropathy (CIPN) in Patients With First-line mCRC",TERMINATED,,PHASE3,291.0,ACTUAL,Egetis Therapeutics,,3.0,,"On 23 January 2020, the Sponsor announced that the United States (US) Food and Drug Administration (FDA) had issued a clinical hold in the US of the POLAR program.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,INDUSTRY,,,,,,,2020,0.0
NCT05098327,,2021-10-18,,,2023-08-13,2021-10-18,2021-10-28,ACTUAL,,,,,,,2023-08-13,2023-08-15,ACTUAL,2021-08-01,ACTUAL,2021-08-01,2023-08,2023-08-31,2023-03-31,ACTUAL,2023-03-31,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,,,Pioglitazone and Insulin Resistance in ADT,Role of Pioglitazone Therapy in Management of Insulin Resistance Associated With Androgen Deprivation Therapy (ADT) in Patients With Prostate Cancer,WITHDRAWN,,PHASE3,0.0,ACTUAL,State University of New York at Buffalo,,3.0,,no participant enrolled due to lack of interest.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,OTHER,,,,,,,2023,0.0
NCT04655508,,2020-11-10,,,2024-02-27,2020-11-30,2020-12-07,ACTUAL,,,,,,,2024-02-27,2024-02-29,ACTUAL,2021-05-21,ACTUAL,2021-05-21,2024-02,2024-02-29,2023-09-27,ACTUAL,2023-09-27,2023-09-27,ACTUAL,2023-09-27,,INTERVENTIONAL,RESPPEDOBS,,Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation,Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation,TERMINATED,,PHASE3,35.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,insufficient enrollment.,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,OTHER,,,,,,,2023,0.0
NCT03857542,,2019-02-26,2021-11-27,2021-09-08,2021-11-27,2019-02-26,2019-02-28,ACTUAL,2021-11-27,2021-12-29,ACTUAL,2021-09-08,2021-09-09,ACTUAL,2021-11-27,2021-12-29,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2021-11,2021-11-30,2020-09-10,ACTUAL,2020-09-10,2020-09-10,ACTUAL,2020-09-10,,INTERVENTIONAL,GEMINI 2,Intent-to-treat (ITT) population included all randomized participants.,A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia,"A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Participants With Presbyopia",COMPLETED,,PHASE3,427.0,ACTUAL,Allergan,DCNVA measurements at 1 site were not conducted correctly at the screening and baseline visits; all participants from this site were excluded from efficacy analyses.,2.0,,,f,,,,,t,f,,,,,,After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.,"To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.",http://www.allerganclinicaltrials.com,YES,"Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.",2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,INDUSTRY,,,,,,,2020,1.0
NCT03355066,,2017-11-17,,,2024-08-07,2017-11-21,2017-11-28,ACTUAL,,,,,,,2024-08-07,2024-08-09,ACTUAL,2017-11-06,ACTUAL,2017-11-06,2024-08,2024-08-31,2022-11-14,ACTUAL,2022-11-14,2022-11-14,ACTUAL,2022-11-14,,INTERVENTIONAL,,,A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors,"A Phase 1, Open-Label, Dose-Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,82.0,ACTUAL,"Biosplice Therapeutics, Inc.",,3.0,,Study was terminated due business reasons by Sponsor.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,INDUSTRY,,,,,,,2022,0.0
NCT04747275,,2021-02-03,2022-10-17,,2023-09-11,2021-02-08,2021-02-10,ACTUAL,2023-03-10,2023-04-10,ACTUAL,,,,2023-09-11,2023-09-13,ACTUAL,2021-01-18,ACTUAL,2021-01-18,2023-09,2023-09-30,2021-11-01,ACTUAL,2021-11-01,2021-11-01,ACTUAL,2021-11-01,,INTERVENTIONAL,,"6 subjects were enrolled and completed the study, however, due to concerns with data collection and integrity, we elected to not use those subjects data moving forward. No further subjects were recruited prior to the study closing",Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients,Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients,TERMINATED,,PHASE4,6.0,ACTUAL,Children's Mercy Hospital Kansas City,,2.0,,Transitioned to multi site study with sponsor,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,OTHER,,,,,,,2021,0.0
NCT02531295,,2015-08-20,2023-07-11,,2024-04-08,2015-08-21,2015-08-24,ESTIMATED,2024-04-08,2024-04-19,ACTUAL,,,,2024-04-08,2024-04-19,ACTUAL,2019-05-15,ACTUAL,2019-05-15,2024-04,2024-04-30,2020-03-19,ACTUAL,2020-03-19,2020-03-19,ACTUAL,2020-03-19,,INTERVENTIONAL,,The study was terminated (Halted Prematurely).,Immunologic Response to Kansui in Treated HIV+ Individuals: a Dose Escalation Study,Immunologic Response to Euphorbia Kansui Extract Powder Prepared as Tea in HIV-infected Antiretroviral Therapy (ART)-Suppressed Individuals: a Dose Escalation Study,TERMINATED,,PHASE1,5.0,ACTUAL,"University of California, San Francisco",,3.0,,Pause on clinical trial enrollment due to grant funding cuts after COVID-19,f,,,,t,t,f,,,,,,,,,,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,OTHER,,,,,,,2020,0.0
NCT04331795,,2020-04-01,2021-04-19,,2022-05-13,2020-04-01,2020-04-02,ACTUAL,2022-05-13,2022-06-09,ACTUAL,,,,2022-05-13,2022-06-09,ACTUAL,2020-04-04,ACTUAL,2020-04-04,2022-05,2022-05-31,2020-06-05,ACTUAL,2020-06-05,2020-06-05,ACTUAL,2020-06-05,,INTERVENTIONAL,COVIDOSE,,"Tocilizumab to Prevent Clinical Decompensation in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis",Early Institution of Tocilizumab Titration in Non-Critical Hospitalized COVID-19 Pneumonitis,COMPLETED,,PHASE2,32.0,ACTUAL,University of Chicago,,2.0,,,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,OTHER,,,,,,,2020,1.0
NCT05543928,,2022-09-13,,,2024-07-23,2022-09-13,2022-09-16,ACTUAL,,,,,,,2024-07-23,2024-07-25,ACTUAL,2023-01-31,ACTUAL,2023-01-31,2024-07,2024-07-31,2024-06-19,ACTUAL,2024-06-19,2024-06-19,ACTUAL,2024-06-19,,INTERVENTIONAL,,,Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism,"A Multi-Center Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CTAP101 Extended-release Capsules to Treat Secondary Hyperparathyroidism in Pediatric Subjects of Ages 8 to <18 Years With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency",TERMINATED,,PHASE3,2.0,ACTUAL,"OPKO Health, Inc.",,2.0,,FDA changed the post-marketing requirement necessitating a new study design and protocol.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,INDUSTRY,,,,,,,2024,0.0
NCT04737174,,2021-01-26,,,2022-03-28,2021-01-31,2021-02-03,ACTUAL,,,,,,,2022-03-28,2022-04-06,ACTUAL,2021-03-25,ESTIMATED,2021-03-25,2022-03,2022-03-31,2022-04,ESTIMATED,2022-04-30,2021-10,ESTIMATED,2021-10-31,,INTERVENTIONAL,,,ES-481 for Uncontrolled Glioma-Associated Epilepsy and Assessment for Potential Anti-Tumorigenic Effect in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Tumors,Adjunctive ES-481 for Uncontrolled Glioma-Associated Epilepsy and Assessment for Potential Anti-Tumorigenic Effect in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Tumors,WITHDRAWN,,PHASE2,0.0,ACTUAL,ES Therapeutics Australia Pty Ltd,,1.0,,Lack of identifiable patients,f,,,,,f,f,,,,,,,,,,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,INDUSTRY,,,,,,,2022,0.0
NCT04109690,,2019-09-27,,,2022-01-06,2019-09-27,2019-09-30,ACTUAL,,,,,,,2022-01-06,2022-01-24,ACTUAL,2019-12-30,ACTUAL,2019-12-30,2022-01,2022-01-31,2021-07-27,ACTUAL,2021-07-27,2021-07-27,ACTUAL,2021-07-27,,INTERVENTIONAL,,,CPX-351 in Patients Treated for Higher-risk Myelodysplastic Syndromes Experiencing Hypomethylating Agent Failure.,A Phase I-II Study of a Liposomal Formulation of Cytarabine and Daunorubicin (CPX-351) in Patients Treated for Higher-risk Myelodysplastic Syndromes Experiencing Hypomethylating Agent Failure.,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Yale University,,1.0,,Failure to enroll,f,,,,t,t,f,,,,,,,,,,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,OTHER,,,,,,,2021,0.0
NCT03625505,,2018-08-08,,,2021-09-07,2018-08-08,2018-08-10,ACTUAL,,,,,,,2021-09-07,2021-09-14,ACTUAL,2018-10-18,ACTUAL,2018-10-18,2021-09,2021-09-30,2021-08-31,ACTUAL,2021-08-31,2021-08-31,ACTUAL,2021-08-31,,INTERVENTIONAL,,,A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia,"A Multicenter, Open-Label Phase 1b Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia",COMPLETED,,PHASE1,61.0,ACTUAL,AbbVie,,2.0,,,t,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,INDUSTRY,,NCT03123029,AVAILABLE,,,,2021,1.0
NCT04006145,,2019-06-29,2021-08-04,,2021-08-31,2019-07-01,2019-07-05,ACTUAL,2021-08-31,2021-09-27,ACTUAL,,,,2021-08-31,2021-09-27,ACTUAL,2019-06-06,ACTUAL,2019-06-06,2021-08,2021-08-31,2020-07-15,ACTUAL,2020-07-15,2020-06-26,ACTUAL,2020-06-26,,INTERVENTIONAL,,,A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH,"A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Explore the Efficacy and Safety of Elobixibat in Adults With Nonalcoholic Fatty Liver Disease (NAFLD) or Nonalcoholic Steatohepatitis (NASH)",COMPLETED,,PHASE2,47.0,ACTUAL,AlbireoPharma,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,UNKNOWN,,,,,,,2020,1.0
NCT04385433,,2020-04-23,,,2023-08-22,2020-05-07,2020-05-13,ACTUAL,,,,,,,2023-08-22,2023-08-24,ACTUAL,2020-12-04,ACTUAL,2020-12-04,2023-05,2023-05-31,2023-04-27,ACTUAL,2023-04-27,2023-04-27,ACTUAL,2023-04-27,,INTERVENTIONAL,PRAVAPREV-01,,A Comparative Study of Pravastatin vs Placebo as Primary Prevention of Severe Subcutaneous Breast Fibrosis in Hyper-radiosensitive Identified Patients With Breast Cancer,A Comparative Study of Pravastatin vs Placebo as Primary Prevention of Severe Subcutaneous Breast Fibrosis in Hyper-radiosensitive Identified Patients With Breast Cancer,TERMINATED,,PHASE3,15.0,ACTUAL,Institut du Cancer de Montpellier - Val d'Aurelle,,2.0,,Not enough patients enrolled,f,,,,t,f,f,,,,,,,,,,,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,OTHER,,,,,,,2023,0.0
NCT04464967,,2020-07-01,,,2021-05-10,2020-07-06,2020-07-09,ACTUAL,,,,,,,2021-05-10,2021-05-12,ACTUAL,2021-03,ESTIMATED,2021-03-31,2021-05,2021-05-31,2023-02,ESTIMATED,2023-02-28,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,,,Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers,"A Phase 1/2a, Open-Label, Multi-Center Study Evaluating the Safety and Anti-Tumor Activity of Ex Vivo Expanded, Autologous Natural Killer Cells (SNK01) in Combination With Trastuzumab or Cetuximab in Subjects With Advanced/Metastatic HER2- or EGFR-Expressing Cancers",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"NKGen Biotech, Inc.",,6.0,,Trial not initiated,f,,,,,t,f,,,,,,,,,,,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,INDUSTRY,,,,,,,2023,0.0
NCT04330144,,2020-03-30,,,2021-08-02,2020-03-31,2020-04-01,ACTUAL,,,,,,,2021-08-02,2021-08-09,ACTUAL,2020-04-01,ACTUAL,2020-04-01,2021-08,2021-08-31,2020-06-29,ACTUAL,2020-06-29,2020-06-29,ACTUAL,2020-06-29,,INTERVENTIONAL,COVID-19,,Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial),A Study of Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial),WITHDRAWN,,PHASE3,0.0,ACTUAL,Gangnam Severance Hospital,,2.0,,No Participants Enrolled,f,,,,t,f,f,,,f,,,,,,,,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,OTHER,,,,,,,2020,0.0
NCT02367781,,2015-02-13,2019-03-13,,2021-07-15,2015-02-13,2015-02-20,ESTIMATED,2019-03-13,2019-04-03,ACTUAL,,,,2021-07-15,2021-08-09,ACTUAL,2015-04-16,ACTUAL,2015-04-16,2021-07,2021-07-31,2021-01-18,ACTUAL,2021-01-18,2018-03-15,ACTUAL,2018-03-15,,INTERVENTIONAL,IMpower130,,A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC),"A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer",COMPLETED,,PHASE3,723.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,INDUSTRY,,,,,,,2021,1.0
NCT03976206,,2019-05-31,,,2020-10-13,2019-06-03,2019-06-05,ACTUAL,,,,,,,2020-10-13,2020-10-19,ACTUAL,2019-07-06,ACTUAL,2019-07-06,2019-06,2019-06-30,2020-07-01,ACTUAL,2020-07-01,2020-05-20,ACTUAL,2020-05-20,,INTERVENTIONAL,,,Very Small Embryonic-like Stem Cells for Facial Skin Antiaging,Autologous Very Small Embryonic-like Stem Cells(VSELs) for Facial Skin Antiaging,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Fuda Cancer Hospital, Guangzhou",,4.0,,Policy changes have contributed to the failure to carry out smoothly,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,OTHER,,,,,,,2020,0.0
NCT03628924,,2018-08-09,2021-05-18,,2021-05-18,2018-08-09,2018-08-14,ACTUAL,2021-05-18,2021-06-14,ACTUAL,,,,2021-05-18,2021-06-14,ACTUAL,2018-09-04,ACTUAL,2018-09-04,2021-05,2021-05-31,2020-05-22,ACTUAL,2020-05-22,2020-05-22,ACTUAL,2020-05-22,,INTERVENTIONAL,NOVA,,"A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)","A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Subjects With Moderate to Severe Hidradenitis Suppurativa",COMPLETED,,PHASE2,184.0,ACTUAL,"Janssen Research & Development, LLC",,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,INDUSTRY,,,,,,,2020,1.0
NCT04342221,,2020-04-08,,,2021-04-28,2020-04-09,2020-04-10,ACTUAL,,,,,,,2021-04-28,2021-05-03,ACTUAL,2020-03-29,ACTUAL,2020-03-29,2020-03,2020-03-31,2021-02-26,ACTUAL,2021-02-26,2021-02-26,ACTUAL,2021-02-26,,INTERVENTIONAL,COV-HCQ,,Hydroxychloroquine for COVID-19,Randomized Controlled Trial of Hydroxychloroquine Versus Placebo for the Treatment of Adult Patients With Acute Coronavirus Disease 2019 - COVID-19,TERMINATED,,PHASE3,30.0,ACTUAL,University Hospital Tuebingen,,2.0,,Reduced acceptance of IMP,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,OTHER,,,,,,,2021,0.0
NCT03526185,,2018-01-22,,,2022-07-20,2018-05-03,2018-05-16,ACTUAL,,,,,,,2022-07-20,2022-07-25,ACTUAL,2018-02-06,ACTUAL,2018-02-06,2022-07,2022-07-31,2020-12-01,ACTUAL,2020-12-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,,,A Pilot Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes,A Pilot Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Melanoma,TERMINATED,,EARLY_PHASE1,6.0,ACTUAL,Yale University,,2.0,,lack of funds,,,,,t,t,f,,,,,,,,,,,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,OTHER,,,,,,,2020,0.0
NCT03445000,,2018-01-05,,,2022-08-23,2018-02-23,2018-02-26,ACTUAL,,,,,,,2022-08-23,2022-08-24,ACTUAL,2018-11-06,ACTUAL,2018-11-06,2022-08,2022-08-31,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,ALERT-lung,,ALEctinib for the Treatment of Pretreated RET-rearranged Advanced Non-small Cell Lung Cancer,A Single Arm Phase II Trial Evaluating the Activity of Alectinib for the Treatment of Pretreated RET-rearranged Advanced NSCLC,TERMINATED,,PHASE2,14.0,ACTUAL,ETOP IBCSG Partners Foundation,,1.0,,Low recruitment rate,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,NETWORK,,,,,,,2021,0.0
NCT04530474,,2020-08-26,,,2021-05-24,2020-08-26,2020-08-28,ACTUAL,,,,,,,2021-05-24,2021-05-26,ACTUAL,2021-04-01,ACTUAL,2021-04-01,2021-05,2021-05-31,2021-06-30,ESTIMATED,2021-06-30,2021-06-30,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,Outpatient Use of Ivermectin in COVID-19,Outpatient Use of Ivermectin in COVID-19,WITHDRAWN,,PHASE3,0.0,ACTUAL,Temple University,,2.0,,WHO report,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,OTHER,,,,,,,2021,0.0
NCT03987503,,2019-06-12,,,2023-01-17,2019-06-14,2019-06-17,ACTUAL,,,,,,,2023-01-17,2023-01-19,ACTUAL,2020-07-01,ACTUAL,2020-07-01,2023-01,2023-01-31,2022-12-29,ACTUAL,2022-12-29,2022-10-30,ACTUAL,2022-10-30,,INTERVENTIONAL,NOW,,The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study,The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study,COMPLETED,,PHASE4,86.0,ACTUAL,"University of California, San Francisco",,2.0,,,f,,,,,t,t,,,f,,,,,,NO,"Summary statistics of primary and secondary outcome data and overall sample demographics (e.g., gender, age, ethnicity/race) will be shared with researchers through annual conference presentations and final results related to the study aims will be disseminated via peer-reviewed manuscripts.",2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,OTHER,,,,,,,2022,0.0
NCT03669549,,2018-09-10,2021-01-26,,2021-02-11,2018-09-11,2018-09-13,ACTUAL,2021-02-11,2021-03-04,ACTUAL,,,,2021-02-11,2021-03-04,ACTUAL,2018-07-11,ACTUAL,2018-07-11,2021-02,2021-02-28,2020-07-12,ACTUAL,2020-07-12,2020-06-03,ACTUAL,2020-06-03,,INTERVENTIONAL,,,Nevanimibe HCl for the Treatment of Classic CAH,A Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of Classic Congenital Adrenal Hyperplasia,TERMINATED,,PHASE2,15.0,ACTUAL,"Millendo Therapeutics, Inc.",Nevanimibe hydrochloride administered orally at doses of 500-2000 mg BID for up to 16 weeks in the first 10 evaluable patients did not result in sufficient efficacy. The Sponsor has decided to refrain from further development at this time.,1.0,,"Following an interim data review, further investment in nevanimibe has been discontinued",f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 00:53:51.885073,2024-10-17 00:53:51.885073,INDUSTRY,,,,,,,2020,0.0
NCT04750759,,2021-02-08,,,2021-11-26,2021-02-08,2021-02-11,ACTUAL,,,,,,,2021-11-26,2021-12-09,ACTUAL,2021-02-03,ACTUAL,2021-02-03,2021-11,2021-11-30,2021-10-29,ACTUAL,2021-10-29,2021-10-29,ACTUAL,2021-10-29,,INTERVENTIONAL,NICCAM,,Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat,"A Randomized, Single Blind, Placebo-controlled, Multiple Dose, Parallel-arm Study to Investigate the Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat to Treat COVID-19 (NICCAM)",TERMINATED,,PHASE2,4.0,ACTUAL,Charité Research Organisation GmbH,,2.0,,sub-therapeutic plasma levels of active substance,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,OTHER,,,,,,,2021,0.0
NCT02426125,,2015-04-21,2019-01-25,2017-08-15,2023-08-17,2015-04-21,2015-04-24,ESTIMATED,2019-03-06,2019-03-08,ACTUAL,2017-08-15,2017-08-18,ACTUAL,2023-08-17,2023-08-21,ACTUAL,2015-07-13,ACTUAL,2015-07-13,2023-08,2023-08-31,2022-07-26,ACTUAL,2022-07-26,2017-04-21,ACTUAL,2017-04-21,,INTERVENTIONAL,RANGE,All randomized participants.,A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab Plus Docetaxel Versus Placebo Plus Docetaxel in Patients With Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum-Based Therapy",COMPLETED,,PHASE3,530.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,,,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,INDUSTRY,,,,,,,2022,1.0
NCT05255484,,2022-02-14,,,2023-10-24,2022-02-16,2022-02-24,ACTUAL,,,,,,,2023-10-24,2023-10-25,ACTUAL,2022-05-26,ACTUAL,2022-05-26,2023-10,2023-10-31,2023-10-06,ACTUAL,2023-10-06,2023-10-06,ACTUAL,2023-10-06,,INTERVENTIONAL,,,Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumours,"A Phase I/II, Open-Label, Dose Escalation and Expansion Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,24.0,ACTUAL,LaNova Medicines Limited,,4.0,,Completed primary objective.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,INDUSTRY,,,,,,,2023,0.0
NCT04157088,,2019-10-21,2023-06-12,,2023-07-14,2019-11-06,2019-11-08,ACTUAL,2023-07-14,2023-08-04,ACTUAL,,,,2023-07-14,2023-08-04,ACTUAL,2019-12-17,ACTUAL,2019-12-17,2023-07,2023-07-31,2022-07-08,ACTUAL,2022-07-08,2022-07-08,ACTUAL,2022-07-08,,INTERVENTIONAL,DaroAcT,,"Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)","A Randomized, Open-label, Multicenter, Phase 2b Study to Evaluate Physical Function, Including Balance and Daily Activity, in Participants With Castration-resistant Prostate Cancer Treated With Darolutamide or Enzalutamide",TERMINATED,,PHASE2,30.0,ACTUAL,Bayer,"A total of 30 participants received treatment with darolutamide 600 mg twice daily in the lead in phase of the study, comprising the safety evaluable population.~No participant received either darolutamide or enzalutamide in the randomized phase of the study as the study was terminated prematurely prior to the initiation of the randomized phase of the study.",2.0,,The results of the lead-in phase did not fulfill the criteria set for moving into the randomized phase,f,,,,f,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,INDUSTRY,,,,,,,2022,0.0
NCT03836157,,2019-02-07,,,2019-06-25,2019-02-07,2019-02-11,ACTUAL,,,,,,,2019-06-25,2019-06-27,ACTUAL,2019-05-31,ESTIMATED,2019-05-31,2019-06,2019-06-30,2022-05,ESTIMATED,2022-05-31,2021-11-30,ESTIMATED,2021-11-30,,INTERVENTIONAL,,,Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer,Phase II Trial of Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Oklahoma,,1.0,,Study was not initiated.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,OTHER,,,,,,,2022,0.0
NCT04003974,,2019-06-25,2024-01-16,2022-01-27,2024-06-13,2019-06-28,2019-07-01,ACTUAL,2024-06-13,2024-07-10,ACTUAL,,2024-07-10,ACTUAL,2024-06-13,2024-07-10,ACTUAL,2019-08-09,ACTUAL,2019-08-09,2024-06,2024-06-30,2021-01-28,ACTUAL,2021-01-28,2021-01-28,ACTUAL,2021-01-28,,INTERVENTIONAL,FSHD,Full Analysis Set: included all participants who were randomly assigned to receive double-blind study drug in the placebo-controlled treatment period.,Efficacy and Safety of Losmapimod in Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD),"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD)",COMPLETED,,PHASE2,80.0,ACTUAL,Fulcrum Therapeutics,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,INDUSTRY,,,,,,,2021,1.0
NCT03138538,,2017-04-26,2021-12-21,,2021-12-21,2017-05-02,2017-05-03,ACTUAL,2021-12-21,2022-03-11,ACTUAL,,,,2021-12-21,2022-03-11,ACTUAL,2017-08-08,ACTUAL,2017-08-08,2021-12,2021-12-31,2020-09-16,ACTUAL,2020-09-16,2020-09-16,ACTUAL,2020-09-16,,INTERVENTIONAL,M8891,Safety analysis set included all participants who received at least 1 dose of study drug.,M8891 First in Human in Solid Tumors,"An Open-label, Phase I Dose Escalation Trial of Methionine Aminopeptidase 2 Inhibitor M8891 in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,27.0,ACTUAL,EMD Serono,,6.0,,"As part of a portfolio-level management of the company's oncology pipeline, it was decided to stop the next phase of internal development of the MetAP2 (M8891) program to enable realization of other opportunities within the oncology portfolio.",f,,,,f,t,f,,,,,,,,,NO,"Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html",2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,INDUSTRY,,,,,,,2020,0.0
NCT02749227,,2016-04-20,2021-03-31,,2021-03-31,2016-04-20,2016-04-22,ESTIMATED,2021-03-31,2021-04-27,ACTUAL,,,,2021-03-31,2021-04-27,ACTUAL,2017-07-10,ACTUAL,2017-07-10,2020-03,2020-03-31,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,PASSILCORT,,Pasireotide LAR Therapy of Silent Corticotroph Pituitary Tumors,Pilot Study of Pasireotide LAR Treatment of Silent Corticotrophin Pituitary Tumors and Effects on Plasma Levels of POMC,TERMINATED,,PHASE2,4.0,ACTUAL,Columbia University,The study was terminated due to poor enrollment.,1.0,,Lack of funding,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,OTHER,,,,,,,2020,0.0
NCT03486899,,2018-03-30,2022-08-16,2021-07-09,2022-08-16,2018-03-30,2018-04-03,ACTUAL,2022-08-16,2022-09-09,ACTUAL,2021-07-09,2021-07-13,ACTUAL,2022-08-16,2022-09-09,ACTUAL,2018-06-19,ACTUAL,2018-06-19,2022-08,2022-08-31,2021-08-17,ACTUAL,2021-08-17,2020-09-14,ACTUAL,2020-09-14,,INTERVENTIONAL,FALCON 1,,A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis,"A Phase 2B Randomized Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis",COMPLETED,,PHASE2,197.0,ACTUAL,Bristol-Myers Squibb,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,INDUSTRY,,,,,,,2021,1.0
NCT03630159,,2018-08-01,,,2022-08-11,2018-08-09,2018-08-14,ACTUAL,,,,,,,2022-08-11,2022-08-15,ACTUAL,2018-10-09,ACTUAL,2018-10-09,2022-08,2022-08-31,2021-07-20,ACTUAL,2021-07-20,2021-07-20,ACTUAL,2021-07-20,,INTERVENTIONAL,PORTIA,,Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients,Phase Ib Study of Tisagenlecleucel in Combination With Pembrolizumab in Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL) Patients.,COMPLETED,,PHASE1,12.0,ACTUAL,Novartis,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,INDUSTRY,,,,,,,2021,1.0
NCT03990077,,2019-06-12,,,2021-11-29,2019-06-15,2019-06-18,ACTUAL,,,,,,,2021-11-29,2021-12-10,ACTUAL,2020-05-21,ACTUAL,2020-05-21,2020-12,2020-12-31,2021-07-20,ACTUAL,2021-07-20,2021-07-20,ACTUAL,2021-07-20,,INTERVENTIONAL,,,Study of HL-085 Plus Docetaxel in Patients With KRAS Mutant NSCLC,"A Phase I , Single Arm, Dose Escalation Study to Evaluate Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 Plus Docetaxel in Patients With KRAS Mutant NSCLC",TERMINATED,,PHASE1,2.0,ACTUAL,"Shanghai Kechow Pharma, Inc.",,1.0,,drug development strategy adjustment,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,INDUSTRY,,,,,,,2021,0.0
NCT04752371,,2021-02-09,,,2023-08-22,2021-02-09,2021-02-12,ACTUAL,,,,,,,2023-08-22,2023-08-23,ACTUAL,2021-03-25,ACTUAL,2021-03-25,2023-08,2023-08-31,2022-05-24,ACTUAL,2022-05-24,2022-05-24,ACTUAL,2022-05-24,,INTERVENTIONAL,,,A Study to Evaluate Camoteskimab in Participants With Still's Disease,"A Phase 1b, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Camoteskimab in Subjects With Adult Onset Still's Disease",TERMINATED,,PHASE1,5.0,ACTUAL,Apollo Therapeutics Ltd,,2.0,,Sponsor discretion,f,,,,,t,f,,,,,,,,,NO,,2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,INDUSTRY,,,,,,,2022,0.0
NCT01420926,,2011-08-19,2016-08-30,,2023-02-02,2011-08-19,2011-08-22,ESTIMATED,2016-08-30,2016-10-24,ESTIMATED,,,,2023-02-02,2023-02-28,ACTUAL,2011-11-16,ACTUAL,2011-11-16,2023-02,2023-02-28,2021-04-01,ACTUAL,2021-04-01,2016-06-05,ACTUAL,2016-06-05,,INTERVENTIONAL,,Two (2) participants never received any protocol treatment; per study design these patients were excluded from all analyses.,Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia,A Randomized Phase II Trial of Decitabine-Based Induction Strategies for Patients &gt;/= 60 Years Old With Acute Myeloid Leukemia (AML),COMPLETED,,PHASE2,165.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,NIH,,,,,,,2021,1.0
NCT05030350,,2021-08-26,,2023-09-15,2023-09-15,2021-08-26,2021-09-01,ACTUAL,,,,,2023-09-21,ACTUAL,2023-09-15,2023-09-21,ACTUAL,2021-10-01,ACTUAL,2021-10-01,2023-09,2023-09-30,2022-09-23,ACTUAL,2022-09-23,2022-09-23,ACTUAL,2022-09-23,,INTERVENTIONAL,,,Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD),A Phase 3 Open-label Safety Trial of PH94B Nasal Spray in the Acute Treatment of Anxiety in Adult Subjects With Social Anxiety Disorder (SAD),TERMINATED,,PHASE3,483.0,ACTUAL,"VistaGen Therapeutics, Inc.",,1.0,,Study stopped by the sponsor for business reasons and not due to any safety concerns with PH94B,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,INDUSTRY,,,,,,,2022,0.0
NCT04091880,,2019-09-15,,,2022-10-10,2019-09-16,2019-09-17,ACTUAL,,,,,,,2022-10-10,2022-10-12,ACTUAL,2019-09-26,ACTUAL,2019-09-26,2022-10,2022-10-31,2021-08-10,ACTUAL,2021-08-10,2020-01-06,ACTUAL,2020-01-06,,INTERVENTIONAL,,,Evaluation of the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine,"A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine (Split Virion),Inactivated",COMPLETED,,PHASE4,1134.0,ACTUAL,China National Biotec Group Company Limited,,3.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,INDUSTRY,,,,,,,2021,1.0
NCT03382600,,2017-12-19,2022-05-09,,2024-05-28,2017-12-19,2017-12-26,ACTUAL,2023-02-28,2023-12-01,ACTUAL,,,,2024-05-28,2024-06-11,ACTUAL,2018-03-26,ACTUAL,2018-03-26,2024-05,2024-05-31,2021-05-30,ACTUAL,2021-05-30,2021-05-30,ACTUAL,2021-05-30,,INTERVENTIONAL,,,Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With TS-1+Cisplatin or TS-1+Oxaliplatin as First Line Chemotherapy in Gastric Cancer (MK-3475-659/KEYNOTE-659),"A Phase IIb, Clinical Trial to Study the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With TS-1+Cisplatin or TS-1+Oxaliplatin as a First Line Chemotherapy in Participants With Advanced or Recurrent Gastric Cancer (KEYNOTE-659)",COMPLETED,,PHASE2,100.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,f,f,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,INDUSTRY,,,,,,,2021,1.0
NCT03870399,,2019-03-06,,,2024-05-03,2019-03-08,2019-03-12,ACTUAL,,,,,,,2024-05-03,2024-05-06,ACTUAL,2019-03-13,ACTUAL,2019-03-13,2024-05,2024-05-31,2023-05-13,ACTUAL,2023-05-13,2023-05-13,ACTUAL,2023-05-13,,INTERVENTIONAL,HORMONET,,Study of Tamoxifen in Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression,Phase II Study of Hormone Therapy With Tamoxifen in Patients With Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression,COMPLETED,,PHASE2,23.0,ACTUAL,AC Camargo Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,OTHER,,,,,,,2023,0.0
NCT05044429,,2021-04-13,2024-02-08,,2024-03-15,2021-09-10,2021-09-14,ACTUAL,2024-03-15,2024-03-18,ACTUAL,,,,2024-03-15,2024-03-18,ACTUAL,2021-03-16,ACTUAL,2021-03-16,2024-03,2024-03-31,2023-11-29,ACTUAL,2023-11-29,2023-11-29,ACTUAL,2023-11-29,,INTERVENTIONAL,,,Postoperative Pain Control Following Renal Transplant,Postoperative Pain Control With Systemic Lidocaine vs. Regional Anesthesia in Renal Transplant Patients,TERMINATED,,PHASE4,31.0,ACTUAL,George Washington University,,3.0,,Lack of interest for continuing on by PI and issues with IRB,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,OTHER,,,,,,,2023,0.0
NCT04978324,,2021-07-16,,,2022-05-06,2021-07-16,2021-07-27,ACTUAL,,,,,,,2022-05-06,2022-05-12,ACTUAL,2022-05,ESTIMATED,2022-05-31,2022-05,2022-05-31,2022-12,ESTIMATED,2022-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Scaling and Root Planning With Localized Delivery of Autogenous Growth Factors- Platelet Rich Fibrin (PRF),Scaling and Root Planning With Localized Delivery of Autogenous Growth Factors- Platelet Rich Fibrin (PRF): A Randomized Split-mouth Clinical Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,Virginia Commonwealth University,,2.0,,Fellow graduated before successfully enrolling any participants,f,,,,,t,f,,,f,,,,,,NO,,2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,OTHER,,,,,,,2022,0.0
NCT06012565,,2023-08-24,,,2023-08-24,2023-08-24,2023-08-25,ACTUAL,,,,,,,2023-08-24,2023-08-25,ACTUAL,2020-10-11,ACTUAL,2020-10-11,2023-08,2023-08-31,2021-08-07,ACTUAL,2021-08-07,2021-08-07,ACTUAL,2021-08-07,,INTERVENTIONAL,,,KAND567 Versus Placebo in Subjects Hospitalized With COVID-19,"KAND567 Versus Placebo in Subjects Hospitalized With COVID-19. A Phase II, Randomized, 2-Arm Parallel-Group, Double-blind Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics",TERMINATED,,PHASE2,35.0,ACTUAL,Kancera AB,,2.0,,Slow recruitment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,INDUSTRY,,,,,,,2021,0.0
NCT03729596,,2018-10-30,,,2024-04-22,2018-10-31,2018-11-02,ACTUAL,,,,,,,2024-04-22,2024-04-23,ACTUAL,2018-11-21,ACTUAL,2018-11-21,2024-03,2024-03-31,2023-03-18,ACTUAL,2023-03-18,2023-03-18,ACTUAL,2023-03-18,,INTERVENTIONAL,,,MGC018 With or Without MGA012 in Advanced Solid Tumors,"A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,143.0,ACTUAL,MacroGenics,,10.0,,Business decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,INDUSTRY,,,,,,,2023,0.0
NCT05525455,,2022-08-22,,,2023-10-26,2022-08-30,2022-09-01,ACTUAL,,,,,,,2023-10-26,2023-10-30,ACTUAL,2022-08-29,ACTUAL,2022-08-29,2023-10,2023-10-31,2023-09-07,ACTUAL,2023-09-07,2023-09-07,ACTUAL,2023-09-07,,INTERVENTIONAL,,,TT-816 as Monotherapy or in Combination With a PD-1 Inhibitor in Patients With Advanced Cancers (SEABEAM) (MK3475-E88),"A Phase 1/2, First-in-human Study of the Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of TT-816 as Monotherapy or in Combination With a PD-1 Inhibitor in Patients With Advanced Cancers (SEABEAM) (MK3475-E88)",TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,"Teon Therapeutics, Inc.",,2.0,,Company operational decision. Decision to stop study is not due to safety or efficacy concerns.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,INDUSTRY,,,,,,,2023,0.0
NCT04228601,,2020-01-09,,,2024-08-14,2020-01-13,2020-01-14,ACTUAL,,,,,,,2024-08-14,2024-08-16,ACTUAL,2020-01-21,ACTUAL,2020-01-21,2024-08,2024-08-31,2023-01-15,ACTUAL,2023-01-15,2022-08-10,ACTUAL,2022-08-10,,INTERVENTIONAL,,,A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Advanced Pancreatic Cancer,"A Phase Ib/II Study to Assess the Tolerability, Safety and Efficacy of Fluzoparib in Combination With mFOLFIRINOX Followed by Fluzoparib Maintenance Monotherapy in Patients With Advanced Pancreatic Cancer",COMPLETED,,PHASE1/PHASE2,39.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,INDUSTRY,,,,,,,2023,1.0
NCT04375202,,2020-04-29,,,2022-11-02,2020-05-03,2020-05-05,ACTUAL,,,,,,,2022-11-02,2022-11-07,ACTUAL,2020-04-18,ACTUAL,2020-04-18,2022-11,2022-11-30,2021-10-31,ACTUAL,2021-10-31,2021-10-31,ACTUAL,2021-10-31,,INTERVENTIONAL,COLVID-19,,Colchicine in COVID-19: a Pilot Study,Treatment With COLchicine of Patients Affected by COVID-19: a Pilot Study,TERMINATED,,PHASE2,227.0,ACTUAL,University Of Perugia,,2.0,,Insufficient rate of patient accrual and newly available scientific evidence,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,OTHER,,,,,,,2021,0.0
NCT04839549,,2020-10-19,,,2023-06-14,2021-04-08,2021-04-09,ACTUAL,,,,,,,2023-06-14,2023-06-18,ACTUAL,2020-06-06,ACTUAL,2020-06-06,2023-06,2023-06-30,2022-11-29,ACTUAL,2022-11-29,2022-11-29,ACTUAL,2022-11-29,,INTERVENTIONAL,,,Efficacy and Safety of Dextenza Compared to Topical Fluorometholone in Patients With Ocular Rosacea,"Randomized, Open Label, Prospective Study on the Efficacy and Safety of Dextenza Compared to Topical Fluorometholone in Patients With Ocular Rosacea (ROSE Study)",WITHDRAWN,,PHASE4,0.0,ACTUAL,Eye Associates of Central Texas,,2.0,,Lack of patient enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,OTHER,,,,,,,2022,0.0
NCT04202497,,2019-12-12,2021-03-16,,2021-07-09,2019-12-16,2019-12-17,ACTUAL,2021-07-09,2021-07-30,ACTUAL,,,,2021-07-09,2021-07-30,ACTUAL,2019-12-18,ACTUAL,2019-12-18,2021-07,2021-07-31,2020-03-19,ACTUAL,2020-03-19,2020-03-05,ACTUAL,2020-03-05,,INTERVENTIONAL,,The safety set included all enrolled participants who received at least 1 dose of \[18F\]MNI-1054 or TAK-418.,A Study With [18F]MNI-1054 to Determine Lysine -Specific Demethylase 1A (LSD1) Brain Enzyme Occupancy of TAK-418 After Single-Dose Oral Administration in Healthy Participants,"A Phase 1, Open-label, Positron Emission Tomography Study With [18F]MNI-1054 to Determine Lysine-Specific Demethylase 1A Brain Enzyme Occupancy of TAK-418 After Single-Dose Oral Administration in Healthy Subjects",TERMINATED,,PHASE1,7.0,ACTUAL,Takeda,,1.0,,Study was prematurely terminated because of administrative reasons.,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,INDUSTRY,,,,,,,2020,0.0
NCT03221842,,2017-07-17,2021-11-18,,2022-07-25,2017-07-17,2017-07-19,ACTUAL,2021-12-17,2022-01-18,ACTUAL,,,,2022-07-25,2022-07-29,ACTUAL,2017-11-06,ACTUAL,2017-11-06,2022-07,2022-07-31,2021-01-20,ACTUAL,2021-01-20,2021-01-20,ACTUAL,2021-01-20,,INTERVENTIONAL,,,Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients,"A Double-blind, Randomized-withdrawal, Placebo-controlled Study to Evaluate the Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection in Adult Renal Transplant Recipients",TERMINATED,,PHASE3,63.0,ACTUAL,CSL Behring,"The Sponsor terminated the study due to futility of enrolment. Because of the study termination, there are limitations in interpreting analyses and efficacy results based on small numbers of subjects. No subject reached the 48-month follow-up endpoint.",2.0,,The study was terminated early due to futility of enrolment and not for safety reasons.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,INDUSTRY,,,,,,,2021,0.0
NCT03166787,,2017-03-30,,,2021-04-07,2017-05-23,2017-05-25,ACTUAL,,,,,,,2021-04-07,2021-04-09,ACTUAL,2017-08-15,ACTUAL,2017-08-15,2021-04,2021-04-30,2020-10-15,ACTUAL,2020-10-15,2020-04-15,ACTUAL,2020-04-15,,INTERVENTIONAL,,,"Hookah Smoking, Carbon Monoxide, and Coronary Endothelial Function","Hookah Smoking, Carbon Monoxide, and Coronary Endothelial Function",TERMINATED,,PHASE1,60.0,ACTUAL,Cedars-Sinai Medical Center,,3.0,,Due to the Pandemic and the nature of this study we decided to terminate this study.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,OTHER,,,,,,,2020,0.0
NCT04577794,,2020-09-30,2022-04-27,,2022-04-27,2020-09-30,2020-10-08,ACTUAL,2022-04-27,2023-01-27,ACTUAL,,,,2022-04-27,2023-01-27,ACTUAL,2020-10-05,ACTUAL,2020-10-05,2022-04,2022-04-30,2021-05-31,ACTUAL,2021-05-31,2021-05-17,ACTUAL,2021-05-17,,INTERVENTIONAL,SEA TURTLE,Safety analysis set consisted of all participants who received at least 1 dose of investigational product (IP).,A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis,"A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Ulcerative Colitis",COMPLETED,,PHASE2,31.0,ACTUAL,Galapagos NV,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,INDUSTRY,,,,,,,2021,1.0
NCT03319316,,2017-10-16,,,2021-12-17,2017-10-19,2017-10-24,ACTUAL,,,,,,,2021-12-17,2022-01-10,ACTUAL,2018-11-01,ESTIMATED,2018-11-01,2021-12,2021-12-31,2022-11,ESTIMATED,2022-11-30,2021-11,ESTIMATED,2021-11-30,,INTERVENTIONAL,SOLUTION,,Combination of Durvalumab and Tremelimumab as Maintenance Treatment in Patients With Non Squamous and Squamous (NSCLC),Randomized Phase II Study of Durvalumab and Tremelimumab Combination Versus Standard of Care Following First-line Platinum Based Chemotherapy in Two Cohorts of Patients With Non Squamous and Squamous Non-small-cell Lung Cancer (NSCLC),WITHDRAWN,,PHASE2,0.0,ACTUAL,European Organisation for Research and Treatment of Cancer - EORTC,,4.0,,Interest withdrawn,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,NETWORK,,,,,,,2022,0.0
NCT04141423,,2019-10-16,,,2022-06-22,2019-10-25,2019-10-28,ACTUAL,,,,,,,2022-06-22,2022-06-27,ACTUAL,2019-10-28,ACTUAL,2019-10-28,2022-06,2022-06-30,2021-04-23,ACTUAL,2021-04-23,2021-04-23,ACTUAL,2021-04-23,,INTERVENTIONAL,,,"Evaluation of Pharmacokinetics , Safety, Tolerability and Pharmacodynamics of Biocon Insulin Tregopil","An Open Label, Multiple Ascending Dose Trial in Patients With T1DM to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin Tregopil and to Evaluate the Postprandial Glucose Control With Different Meal Types in Comparison With Insulin Aspart",TERMINATED,,PHASE1,55.0,ACTUAL,Biocon Limited,,4.0,,Part 1 completed. Part 2 not initiated,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,INDUSTRY,,,,,,,2021,0.0
NCT04567173,,2020-09-24,,,2022-05-17,2020-09-24,2020-09-28,ACTUAL,,,,,,,2022-05-17,2022-05-24,ACTUAL,2020-09-21,ACTUAL,2020-09-21,2022-05,2022-05-31,2021-06-30,ACTUAL,2021-06-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,Co-CLARITY,,Convalescent Plasma as Adjunctive Therapy for Hospitalized Patients With COVID-19,"A Randomized, Open-Label, Single Center Clinical Trial to Assess the Efficacy and Safety of Convalescent Plasma to Hospitalized Adult COVID-19 Patients as Adjunctive Therapy to Reduce the Need for ICU Admission: Co-CLARITY Trial",TERMINATED,,PHASE2/PHASE3,44.0,ACTUAL,University of the Philippines,,2.0,,Limited enrolment (unable to achieve target sample size),f,,,,,f,f,,,,,,,,,,,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,OTHER,,,,,,,2021,0.0
NCT04440163,,2020-06-15,2023-03-22,,2023-03-22,2020-06-18,2020-06-19,ACTUAL,2023-03-22,2023-04-18,ACTUAL,,,,2023-03-22,2023-04-18,ACTUAL,2020-06-17,ACTUAL,2020-06-17,2023-03,2023-03-31,2022-07-24,ACTUAL,2022-07-24,2022-07-24,ACTUAL,2022-07-24,,INTERVENTIONAL,,Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. One participant initially randomized to group 3 was excluded from safety population set as the participant received the wrong vaccination (Trumenba + saline).,MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age,"A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY PARTICIPANTS ≥10 TO <26 YEARS OF AGE",COMPLETED,,PHASE3,2431.0,ACTUAL,Pfizer,,8.0,,,f,,,,,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,INDUSTRY,,,,,,,2022,0.0
NCT04261075,,2020-01-07,,,2022-08-12,2020-02-06,2020-02-07,ACTUAL,,,,,,,2022-08-12,2022-08-15,ACTUAL,2020-03-03,ACTUAL,2020-03-03,2022-08,2022-08-31,2022-06-16,ACTUAL,2022-06-16,2022-06-16,ACTUAL,2022-06-16,,INTERVENTIONAL,,,IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors.,"A Phase 1, First-in-Human, Multicenter, Open-label, Dose-escalation Study of IPH5201 as Monotherapy or in Combination With Durvalumab ± Oleclumab in Advanced Solid Tumors",COMPLETED,,PHASE1,57.0,ACTUAL,MedImmune LLC,,3.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,INDUSTRY,,,,,,,2022,0.0
NCT04641273,,2020-11-20,,,2022-12-08,2020-11-20,2020-11-23,ACTUAL,,,,,,,2022-12-08,2022-12-12,ACTUAL,2021-01-22,ACTUAL,2021-01-22,2022-12,2022-12-31,2021-10-18,ACTUAL,2021-10-18,2021-09-23,ACTUAL,2021-09-23,,INTERVENTIONAL,,,"A 2-part Trial to Learn More About How BAY1817080 Works, How Safe it is, and What the Right Dose is for Participants With Diabetic Neuropathic Pain","A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter Combined Phase 2a/2b Study to Assess the Efficacy and Safety of BAY 1817080 in Patients With Diabetic Neuropathic Pain",TERMINATED,,PHASE2,154.0,ACTUAL,Bayer,,7.0,,Lack of efficacy,f,,,,f,f,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,INDUSTRY,,,,,,,2021,0.0
NCT02028884,,2014-01-06,2020-09-11,2019-06-05,2023-03-23,2014-01-06,2014-01-07,ESTIMATED,2020-12-07,2020-12-31,ACTUAL,2019-06-05,2019-06-07,ACTUAL,2023-03-23,2023-04-18,ACTUAL,2014-02-20,ACTUAL,2014-02-20,2023-03,2023-03-31,2021-12-23,ACTUAL,2021-12-23,2018-06-06,ACTUAL,2018-06-06,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all participants randomized to the treatment groups.,Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD),"A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)",COMPLETED,,PHASE3,85.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,INDUSTRY,,,,,,,2021,1.0
NCT03786380,,2018-12-21,2021-10-05,,2021-11-19,2018-12-21,2018-12-26,ACTUAL,2021-11-19,2021-12-15,ACTUAL,,,,2021-11-19,2021-12-15,ACTUAL,2018-12-20,ACTUAL,2018-12-20,2021-11,2021-11-30,2020-10-05,ACTUAL,2020-10-05,2020-10-05,ACTUAL,2020-10-05,,INTERVENTIONAL,,Enrolled Population included all participants enrolled in the study.,Diabetic Gastroparesis Study 05,Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis,TERMINATED,,PHASE3,202.0,ACTUAL,Allergan,,1.0,,The Relamorelin program is being terminated solely based on a business decision.,f,,,,,t,f,,,,,,,,,NO,,2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,INDUSTRY,,,,,,,2020,0.0
NCT04081350,,2019-09-05,,,2024-02-15,2019-09-05,2019-09-09,ACTUAL,,,,,,,2024-02-15,2024-02-20,ACTUAL,2019-12-04,ACTUAL,2019-12-04,2024-02-15,2024-02-15,2022-06-24,ACTUAL,2022-06-24,2022-06-24,ACTUAL,2022-06-24,,INTERVENTIONAL,,,A Study of LY3471851 in Participants With Eczema,"A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Patients With Atopic Dermatitis",COMPLETED,,PHASE1,48.0,ACTUAL,Nektar Therapeutics,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,INDUSTRY,,,,,,,2022,1.0
NCT04899271,,2021-05-10,,,2023-12-21,2021-05-21,2021-05-24,ACTUAL,,,,,,,2023-12-21,2023-12-22,ACTUAL,2020-12-14,ACTUAL,2020-12-14,2023-12,2023-12-31,2023-10-11,ACTUAL,2023-10-11,2023-04-27,ACTUAL,2023-04-27,,INTERVENTIONAL,,,A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved ß-cell Function at Baseline.,"A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 400 mg Twice a Day Oral Ladarixin in Patients With New-onset Type 1 Diabetes and Preserved Beta-cell Function at Baseline.",TERMINATED,,PHASE2,25.0,ACTUAL,Dompé Farmaceutici S.p.A,,2.0,,low recruitment rate,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,INDUSTRY,,,,,,,2023,0.0
NCT03982004,,2019-06-06,,,2021-06-15,2019-06-06,2019-06-11,ACTUAL,,,,,,,2021-06-15,2021-06-21,ACTUAL,2020-09-14,ACTUAL,2020-09-14,2021-06,2021-06-30,2021-03-03,ACTUAL,2021-03-03,2021-03-03,ACTUAL,2021-03-03,,INTERVENTIONAL,,,Epicutaneous Cryoimmunotherapy Combined With Pembrolizumab for Cutaneous Metastatic Breast Cancer,Phase IB Pilot Study of Epicutaneous Cryoimmunotherapy Combined With Pembrolizumab for Cutaneous Metastatic Breast Cancer,TERMINATED,,PHASE1,1.0,ACTUAL,Washington University School of Medicine,,1.0,,Sponsor decision.,f,,,,t,t,t,,,f,,,,,,NO,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,OTHER,,,,,,,2021,0.0
NCT04020601,,2019-07-10,,,2024-06-04,2019-07-12,2019-07-16,ACTUAL,,,,,,,2024-06-04,2024-06-06,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2024-06,2024-06-30,2020-03-15,ACTUAL,2020-03-15,2020-03-15,ACTUAL,2020-03-15,,INTERVENTIONAL,,,The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane in Total Shoulder Arthroplasty,The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane in Total Shoulder Arthroplasty,TERMINATED,,PHASE2/PHASE3,17.0,ACTUAL,University of Alberta,,2.0,,COVID-19 Pandemic,f,,,,f,f,f,,,,,,,,,,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,OTHER,,,,,,,2020,0.0
NCT03317795,,2017-10-10,2021-10-08,,2021-11-12,2017-10-18,2017-10-23,ACTUAL,2021-11-12,2021-12-08,ACTUAL,,,,2021-11-12,2021-12-08,ACTUAL,2017-11-14,ACTUAL,2017-11-14,2021-11,2021-11-30,2020-12-28,ACTUAL,2020-12-28,2020-12-28,ACTUAL,2020-12-28,,INTERVENTIONAL,,,Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids,Prospective Randomized Trial of Tranexamic Acid Versus Levonorgestrel Intrauterine System for the Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids,COMPLETED,,PHASE4,18.0,ACTUAL,Mayo Clinic,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,OTHER,,,,,,,2020,1.0
NCT04249427,,2020-01-29,2024-06-24,,2024-08-30,2020-01-29,2020-01-31,ACTUAL,2024-08-30,2024-09-24,ACTUAL,,,,2024-08-30,2024-09-24,ACTUAL,2021-02-10,ACTUAL,2021-02-10,2024-08,2024-08-31,2023-07-11,ACTUAL,2023-07-11,2023-07-11,ACTUAL,2023-07-11,,INTERVENTIONAL,,,Erenumab for Idiosyncratic Facial Pain,"A Randomized, Double-Blinded, Single Site Study to Evaluate the Efficacy of Erenumab for Treatment of Idiosyncratic Facial Pain Mimicking Rhinosinusitis",COMPLETED,,PHASE4,29.0,ACTUAL,Duke University,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,OTHER,,,,,,,2023,1.0
NCT04688775,,2020-12-24,2024-06-14,,2024-07-16,2020-12-24,2020-12-30,ACTUAL,2024-07-16,2024-08-09,ACTUAL,,,,2024-07-16,2024-08-09,ACTUAL,2020-12-23,ACTUAL,2020-12-23,2024-07,2024-07-31,2023-10-05,ACTUAL,2023-10-05,2023-06-14,ACTUAL,2023-06-14,,INTERVENTIONAL,ALLEVIATE,The all-participants-randomized-set (APRS) included all randomized participants. The all-participants-treated set (APTS) included all randomized participants who received infusion with double-blind investigational medicinal product (IMP). Demographic characteristics were collected for the APTS and study-specific characteristics were collected for the APRS.,Eptinezumab in Participants With Episodic Cluster Headache,"Interventional, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Delayed-Start Study to Evaluate the Efficacy and Safety of Eptinezumab in Patients With Episodic Cluster Headache",COMPLETED,,PHASE3,231.0,ACTUAL,H. Lundbeck A/S,,2.0,,,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,INDUSTRY,,,,,,,2023,1.0
NCT03785925,,2018-12-20,2022-12-16,,2023-03-27,2018-12-20,2018-12-24,ACTUAL,2023-03-27,2023-03-28,ACTUAL,,,,2023-03-27,2023-03-28,ACTUAL,2019-04-29,ACTUAL,2019-04-29,2023-03,2023-03-31,2022-06-30,ACTUAL,2022-06-30,2022-02-09,ACTUAL,2022-02-09,,INTERVENTIONAL,PIVOT-10,The analysis population consisted of 188 patients.,A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer,"A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients",COMPLETED,,PHASE2,192.0,ACTUAL,Nektar Therapeutics,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,INDUSTRY,,,,,,,2022,0.0
NCT02769611,,2016-05-10,,,2022-06-01,2016-05-10,2016-05-11,ESTIMATED,,,,,,,2022-06-01,2022-06-06,ACTUAL,2017-06-28,ACTUAL,2017-06-28,2019-05,2019-05-31,2022-01-01,ACTUAL,2022-01-01,2022-01-01,ACTUAL,2022-01-01,,INTERVENTIONAL,,,Ruboxistaurin in New York Heart Failure Classification III-IV Patients,"A Prospective Phase I/II Dose Escalation Pilot Analysis of Ruboxistaurin (LY333531) for Safety in New York Heart Failure Classification III-IV Patients, As Well As For Efficacy in Acutely Augmenting Cardiac Function.",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Tennessee,,3.0,,No funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,OTHER,,,,,,,2022,0.0
NCT03260504,,2017-08-21,,,2023-08-16,2017-08-21,2017-08-24,ACTUAL,,,,,,,2023-08-16,2023-08-21,ACTUAL,2018-08-28,ACTUAL,2018-08-28,2023-08,2023-08-31,2022-07-26,ACTUAL,2022-07-26,2022-07-26,ACTUAL,2022-07-26,,INTERVENTIONAL,,,Aldesleukin and Pembrolizumab in Treating Patients With Advanced or Metastatic Kidney Cancer,A Phase I Trial of Interleukin-2 (Aldesleukin) and Pembrolizumab Combination Therapy for Patients With Advanced Renal Cell Carcinoma,TERMINATED,,PHASE1,6.0,ACTUAL,University of Washington,,1.0,,Insufficient funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:06:23.712875,2024-10-16 03:06:23.712875,OTHER,,,,,,,2022,0.0
NCT04346446,,2020-04-14,,,2020-06-11,2020-04-14,2020-04-15,ACTUAL,,,,,,,2020-06-11,2020-06-12,ACTUAL,2020-04-20,ACTUAL,2020-04-20,2020-06,2020-06-30,2020-05-30,ACTUAL,2020-05-30,2020-05-30,ACTUAL,2020-05-30,,INTERVENTIONAL,,,Efficacy of Convalescent Plasma Therapy in Severely Sick COVID-19 Patients,Efficacy of Convalescent Plasma Therapy in Severely Sick COVID-19 Patients: A Pilot Randomized Controlled Trial,COMPLETED,,PHASE2,29.0,ACTUAL,"Institute of Liver and Biliary Sciences, India",,2.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,OTHER,,,,,,,2020,0.0
NCT05908396,,2023-05-26,,,2024-07-30,2023-06-09,2023-06-18,ACTUAL,,,,,,,2024-07-30,2024-08-01,ACTUAL,2023-08-29,ACTUAL,2023-08-29,2023-08,2023-08-31,2024-02-16,ACTUAL,2024-02-16,2024-02-16,ACTUAL,2024-02-16,,INTERVENTIONAL,,,Evaluation of IGM-2644 in Adults With Relapsed and/or Refractory Multiple Myeloma,"An Open-Label, Multicenter, Phase 1 Study of IGM-2644 in Participants With Relapsed and/or Refractory Multiple Myeloma",TERMINATED,,PHASE1,4.0,ACTUAL,"IGM Biosciences, Inc.",,2.0,,Company Decision,f,,,,t,t,f,,,,,,,,,,,2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,INDUSTRY,,,,,,,2024,0.0
NCT04105985,,2019-09-24,,,2020-06-22,2019-09-24,2019-09-26,ACTUAL,,,,,,,2020-06-22,2020-06-25,ACTUAL,2020-08,ESTIMATED,2020-08-31,2020-06,2020-06-30,2021-08,ESTIMATED,2021-08-31,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,,,Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Endodontics,Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,Virginia Commonwealth University,,2.0,,Manufacturer discontinued drug before any participants could be enrolled.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,OTHER,,,,,,,2021,0.0
NCT02178436,,2014-06-23,2023-09-13,,2023-11-05,2014-06-26,2014-06-30,ESTIMATED,2023-11-05,2023-11-07,ACTUAL,,,,2023-11-05,2023-11-07,ACTUAL,2014-10-31,ACTUAL,2014-10-31,2023-11,2023-11-30,2023-04-05,ACTUAL,2023-04-05,2021-11-27,ACTUAL,2021-11-27,,INTERVENTIONAL,,Group II enrolled no patients because patients refused to undergo the required biopsy.,"Gemcitabine, Nab-paclitaxel and KPT-330 in Advanced Pancreatic Cancer","Phase Ib Study of the Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330), Gemcitabine and Nab-Paclitaxel and Phase II Study of Gemcitabine and Selinexor in Patients With Metastatic Pancreatic Cancer",COMPLETED,,PHASE1/PHASE2,15.0,ACTUAL,Barbara Ann Karmanos Cancer Institute,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 15:54:18.632558,2024-10-15 15:54:18.632558,OTHER,,,,,,,2023,1.0
NCT02765243,,2016-05-03,,,2024-03-14,2016-05-04,2016-05-06,ESTIMATED,,,,,,,2024-03-14,2024-03-15,ACTUAL,2016-01-01,ACTUAL,2016-01-01,2021-08,2021-08-31,2023-12-30,ACTUAL,2023-12-30,2019-01-12,ACTUAL,2019-01-12,,INTERVENTIONAL,4SCAR-GD2,,Anti-GD2 4th Generation CART Cells Targeting Refractory and/or Recurrent Neuroblastoma,Anti-GD2 4th Generation Chimeric Antigen Receptor-modified T Cells (4SCAR-GD2) Targeting Refractory and/or Recurrent Neuroblastoma,COMPLETED,,PHASE1,12.0,ACTUAL,Zhujiang Hospital,,1.0,,,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,OTHER,,,,,,,2023,1.0
NCT03524274,,2018-05-02,,,2020-10-13,2018-05-11,2018-05-14,ACTUAL,,,,,,,2020-10-13,2020-10-19,ACTUAL,2018-04-05,ACTUAL,2018-04-05,2020-05,2020-05-31,2020-08-05,ACTUAL,2020-08-05,2020-05-20,ACTUAL,2020-05-20,,INTERVENTIONAL,,,Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Colorectal Cancer,Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Colorectal Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Fuda Cancer Hospital, Guangzhou",,3.0,,No participants enrolled,f,,,,f,f,f,,,,,,,,,,,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,OTHER,,,,,,,2020,0.0
NCT03760523,,2018-11-27,,,2024-08-22,2018-11-29,2018-11-30,ACTUAL,,,,,,,2024-08-22,2024-08-23,ACTUAL,2019-04-18,ACTUAL,2019-04-18,2024-08,2024-08-31,2023-10-09,ACTUAL,2023-10-09,2023-10-09,ACTUAL,2023-10-09,,INTERVENTIONAL,,,Dose Escalation Study of Minnelide in Relapsed or Refractory Acute Myeloid Leukemia,Phase 1/1b Dose Escalation Study of Minnelide in Relapsed or Refractory Acute Myeloid Leukemia,TERMINATED,,PHASE1,27.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,1.0,,Toxicity -Two DLT events occurred,,,,,f,t,f,,,,,,,,,,,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,OTHER,,,,,,,2023,0.0
NCT03724357,,2018-10-26,2022-03-30,,2023-01-23,2018-10-29,2018-10-30,ACTUAL,2023-01-23,2023-02-02,ACTUAL,,,,2023-01-23,2023-02-02,ACTUAL,2018-11-04,ACTUAL,2018-11-04,2023-01,2023-01-31,2021-10-28,ACTUAL,2021-10-28,2021-10-28,ACTUAL,2021-10-28,,INTERVENTIONAL,,,Blood Donor CVD 9000,Blood Donor CVD 9000: Collection of Blood for In Vitro Studies From Healthy Adults Who Have Received Oral Cholera Vaccine (CVD 103-HgR),TERMINATED,,PHASE4,3.0,ACTUAL,"University of Maryland, Baltimore",,1.0,,lack of funding,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,OTHER,,,,,,,2021,0.0
NCT04003142,,2019-06-27,2022-04-01,2021-07-29,2023-09-01,2019-06-27,2019-07-01,ACTUAL,2022-05-19,2022-06-15,ACTUAL,2022-05-19,2022-06-15,ACTUAL,2023-09-01,2023-09-06,ACTUAL,2019-07-10,ACTUAL,2019-07-10,2023-08,2023-08-31,2021-04-23,ACTUAL,2021-04-23,2020-07-30,ACTUAL,2020-07-30,,INTERVENTIONAL,Skylight 2,All randomized participants.,A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2,"A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, Followed by a Non-Controlled Extension Treatment Period, to Assess the Efficacy and Safety of Fezolinetant in Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause",COMPLETED,,PHASE3,501.0,ACTUAL,Astellas Pharma Inc,,5.0,,,f,,,,t,t,f,,,,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://www.clinicalstudydatarequest.com/,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,INDUSTRY,,,,,,,2021,1.0
NCT02636582,,2015-12-18,2023-01-03,2020-07-20,2023-11-16,2015-12-18,2015-12-22,ESTIMATED,2023-04-25,2023-05-16,ACTUAL,2020-07-20,2020-07-23,ACTUAL,2023-11-16,2023-12-05,ACTUAL,2016-06-14,ACTUAL,2016-06-14,2023-11,2023-11-30,2023-05-17,ACTUAL,2023-05-17,2019-07-22,ACTUAL,2019-07-22,,INTERVENTIONAL,,Randomized participants.,Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer,VADIS Trial: Phase II Trial of Nelipeimut-S Peptide Vaccine in Women With DCIS of the Breast,COMPLETED,,PHASE2,43.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,,,,,t,,,,,,,,,,,,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,NIH,,,,,,,2023,1.0
NCT04378569,,2020-04-30,2023-12-15,2021-12-20,2024-04-03,2020-05-04,2020-05-07,ACTUAL,2024-04-03,2024-04-05,ACTUAL,,2024-04-05,ACTUAL,2024-04-03,2024-04-05,ACTUAL,2020-04-20,ACTUAL,2020-04-20,2024-04,2024-04-30,2021-02-24,ACTUAL,2021-02-24,2021-02-24,ACTUAL,2021-02-24,,INTERVENTIONAL,,,Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema,"A Phase 1/2b, Multiple Dose and 12-Week, Parallel Group, Double Blind, Dose Ranging, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-252 Cream 0.1% and ARQ-252 Cream 0.3% in Subjects With Chronic Hand Eczema",COMPLETED,,PHASE1/PHASE2,230.0,ACTUAL,"Arcutis Biotherapeutics, Inc.",,5.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,INDUSTRY,,,,,,,2021,1.0
NCT03935217,,2019-04-30,2021-10-27,,2023-10-02,2019-04-30,2019-05-02,ACTUAL,2023-10-02,2023-10-04,ACTUAL,,,,2023-10-02,2023-10-04,ACTUAL,2019-04-23,ACTUAL,2019-04-23,2023-09,2023-09-30,2020-03-25,ACTUAL,2020-03-25,2020-03-02,ACTUAL,2020-03-02,,INTERVENTIONAL,,Safety Population,A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis,"Multi-center, Prospective, Randomized, Placebo-Controlled, Delayed Treatment, Double-Blind Study to Evaluate the Effectiveness and Safety of a Single Oral Dose of Solosec® for the Treatment of Trichomoniasis",COMPLETED,,PHASE3,147.0,ACTUAL,Lupin Research Inc,,2.0,,,f,,,,f,t,f,,,,,,"After publication of the primary study results, the research team will prepare final research data files that may be shared with other investigators, upon request.","Requests for research data must be submitted to author CAM in writing, via a standard data request form, with a justification for how the data will be used. Author CAM and Lupin Pharmaceuticals will review all requests for research data obtained from this study. The mechanism by which the data will be made available to investigators will follow all NIH guidelines for data sharing as they evolve. At a minimum this would consist of a data use agreement that provides for commitments to use the data for research purposes only, secure the data with appropriate computer technology, obtain IRB approval, and destroy (or return) the data after analyses are complete.",,YES,All IPD that underlie results in a publication,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,INDUSTRY,,,,,,,2020,1.0
NCT04687800,,2020-12-08,,,2022-11-08,2020-12-23,2020-12-29,ACTUAL,,,,,,,2022-11-08,2022-11-10,ACTUAL,2020-12-01,ACTUAL,2020-12-01,2022-11,2022-11-30,2022-10-24,ACTUAL,2022-10-24,2022-10-24,ACTUAL,2022-10-24,,INTERVENTIONAL,,,Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Cataract Surgery,"A Randomized, Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Conjunction With Cataract Surgery Performed in Combination With Minimally Invasive Glaucoma Surgery",TERMINATED,,PHASE4,1.0,ACTUAL,The Eye Associates,,2.0,,Inability to enroll due to lack of access to the Ambulatory Surgery Center.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,OTHER,,,,,,,2022,0.0
NCT02715466,,2016-03-17,,,2024-08-20,2016-03-21,2016-03-22,ESTIMATED,,,,,,,2024-08-20,2024-08-22,ACTUAL,2016-04,,2016-04-30,2024-08,2024-08-31,2021-12-08,ACTUAL,2021-12-08,2021-12-08,ACTUAL,2021-12-08,,INTERVENTIONAL,GENIUS,,Gelatin in ICU and Sepsis,"Prospective, Controlled, Double-Blind, Randomized Multicentric Study On The Efficacy And Safety Of An Early Target Controlled Plasma Volume Replacement Therapy With A Balanced Gelatine Solution vs A Balanced Electrolyte Solution In Patients With Severe Sepsis",TERMINATED,,PHASE4,167.0,ACTUAL,B. Braun Melsungen AG,,2.0,,recommended by DSMB,f,,,,t,,,,,,,,,,,,,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,INDUSTRY,,,,,,,2021,0.0
NCT05137717,,2021-11-25,2024-06-07,,2024-07-03,2021-11-25,2021-11-30,ACTUAL,2024-07-03,2024-07-09,ACTUAL,,,,2024-07-03,2024-07-09,ACTUAL,2022-01-18,ACTUAL,2022-01-18,2024-07,2024-07-31,2023-06-27,ACTUAL,2023-06-27,2023-06-27,ACTUAL,2023-06-27,,INTERVENTIONAL,,Full analysis set (FAS) included of all participants who had taken at least 1 dose of study treatment.,A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) Infection,"A Phase 3, Open-Label, Single-Arm Study to Assess the Efficacy, Safety, and Pharmacokinetics of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Japanese Recipients of a Hematopoietic Stem Cell Transplant (HSCT) or Solid Organ Transplant (SOT)",COMPLETED,,PHASE3,41.0,ACTUAL,Takeda,,1.0,,,f,,,,f,t,f,,,t,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-17 00:59:59.9981,2024-10-17 00:59:59.9981,INDUSTRY,,,,,,,2023,1.0
NCT03748134,,2018-11-12,,,2023-10-22,2018-11-18,2018-11-20,ACTUAL,,,,,,,2023-10-22,2023-10-24,ACTUAL,2018-12-24,ACTUAL,2018-12-24,2023-10,2023-10-31,2023-07-29,ACTUAL,2023-07-29,2021-09-09,ACTUAL,2021-09-09,,INTERVENTIONAL,,,Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 ),"A Multicenter, Double-Blind, Randomized Phase 3 Clinical Trial Evaluating the Efficacy and Safety of Sintilimab vs. Placebo, in Combination With Chemotherapy, for First-Line Treatment of Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma (ORIENT-15)",COMPLETED,,PHASE3,746.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,INDUSTRY,,,,,,,2023,1.0
NCT03788694,,2018-12-26,,,2023-08-03,2018-12-26,2018-12-27,ACTUAL,,,,,,,2023-08-03,2023-08-07,ACTUAL,2020-01-01,ACTUAL,2020-01-01,2023-08,2023-08-31,2020-04-30,ACTUAL,2020-04-30,2020-01-31,ACTUAL,2020-01-31,,INTERVENTIONAL,,,Intranasal Ketamine for Suicidal Ideation in Veterans,"Pilot Study of Open Label, Intranasal Ketamine for Suicidal Ideation in Veterans",WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,"Bronx Veterans Medical Research Foundation, Inc",,1.0,,"Study was never funded nor started, no participants were enrolled",f,,,,t,t,f,,,,,,6 months after publication and will remain available for 5 years.,,,YES,"All IPD that underlie results in publications as well as study protocol, statistical analysis plan, informed consent form.",2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,OTHER,,,,,,,2020,0.0
NCT04818736,,2021-03-24,,,2021-05-12,2021-03-25,2021-03-26,ACTUAL,,,,,,,2021-05-12,2021-05-14,ACTUAL,2021-04-15,ESTIMATED,2021-04-15,2021-02,2021-02-28,2021-12,ESTIMATED,2021-12-31,2021-09,ESTIMATED,2021-09-30,,INTERVENTIONAL,,,COVID-19 Vaccine For Indirect Protection,COVID Vaccine for Indirect Protection: A Cluster Randomized Controlled Trial in Hutterite Colonies,WITHDRAWN,,PHASE4,0.0,ACTUAL,McMaster University,,2.0,,Vaccine roll out plans increased so timing was no longer feasible,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,OTHER,,,,,,,2021,0.0
NCT04006691,,2019-06-12,,,2020-05-05,2019-06-30,2019-07-05,ACTUAL,,,,,,,2020-05-05,2020-05-07,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2020-05,2020-05-31,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ESTIMATED,2020-03-31,,INTERVENTIONAL,Retreatment,,Efficacy and Safety of UGN-101 in Recurrent Patients,A Phase 3b Multicenter Extension Trial Evaluating the Efficacy and Safety of UGN-101 (Mitomycin Gel) for Instillation on Ablation of Upper Urinary Tract Urothelial Carcinoma in Recurrent Patients From Trial TC-UT-03,WITHDRAWN,,PHASE3,0.0,ACTUAL,UroGen Pharma Ltd.,,1.0,,"Due to projected low enrollment, it has decided not to move forward with the study.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,INDUSTRY,,,,,,,2020,0.0
NCT03870334,,2019-03-08,2023-11-10,,2023-11-30,2019-03-08,2019-03-12,ACTUAL,2023-11-30,2023-12-04,ACTUAL,,,,2023-11-30,2023-12-04,ACTUAL,2021-05-05,ACTUAL,2021-05-05,2023-11,2023-11-30,2022-08-26,ACTUAL,2022-08-26,2022-08-26,ACTUAL,2022-08-26,,INTERVENTIONAL,,,Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease,"A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease",TERMINATED,,PHASE2,27.0,ACTUAL,NImmune Biopharma,,2.0,,Decision of Landos Biopharma (not related to safety or efficacy),f,,,,,t,f,,,,,,,,,NO,,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,INDUSTRY,,,,,,,2022,0.0
NCT03962738,,2019-05-23,2021-04-09,,2021-05-17,2019-05-23,2019-05-24,ACTUAL,2021-04-09,2021-05-05,ACTUAL,,,,2021-05-17,2021-06-11,ACTUAL,2019-05-31,ACTUAL,2019-05-31,2021-05,2021-05-31,2020-06-08,ACTUAL,2020-06-08,2020-06-08,ACTUAL,2020-06-08,,INTERVENTIONAL,MONONOFU,All participants who received at least one dose of study drug.,A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine,"RandoMized, DOuble-bliNd, PlacebO-coNtrolled Trial Of Lasmiditan in a Single Migraine Attack in Japanese Patients SuFfering From Migraine With or WithoUt Aura - the MONONOFU Study",COMPLETED,,PHASE2,846.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,f,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,INDUSTRY,,,,,,,2020,1.0
NCT03829930,,2019-01-26,,,2021-07-26,2019-02-01,2019-02-04,ACTUAL,,,,,,,2021-07-26,2021-08-02,ACTUAL,2019-05-01,ACTUAL,2019-05-01,2021-07,2021-07-31,2020-09-01,ACTUAL,2020-09-01,2020-09-01,ACTUAL,2020-09-01,,INTERVENTIONAL,,,Combination of Entinostat and Enzalutamide in Advanced Prostate Cancer,A Phase I Study of Entinostat in Combination With Enzalutamide for Treatment of Patients With Castration-Resistant Prostate Cancer,TERMINATED,,PHASE1,6.0,ACTUAL,George Washington University,,1.0,,Sponsor discontinued the drug,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,OTHER,,,,,,,2020,0.0
NCT04075721,,2019-08-29,2022-06-09,,2022-06-09,2019-08-29,2019-09-03,ACTUAL,2022-06-09,2023-03-24,ACTUAL,,,,2022-06-09,2023-03-24,ACTUAL,2019-09-26,ACTUAL,2019-09-26,2022-06,2022-06-30,2021-04-01,ACTUAL,2021-04-01,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,,Safety analysis set included all participants who were administered any dose of the study medication.,First in Human Dose Escalation of M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone,A Phase I Open Label First in Human Dose Escalation of the Immunoproteasome Inhibitor M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone in Participants With Relapsed Refractory Multiple Myeloma,TERMINATED,,PHASE1,10.0,ACTUAL,EMD Serono,Part B was not conducted as the study was early discontinued due to lack of participant's recruitment into Part A before Part A reached its primary objective.,3.0,,The study was early discontinued due to lack of participant enrollment.,f,,,,f,t,f,,,,,,,,,NO,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website http://bit.ly/IPD21",2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,INDUSTRY,,,,,,,2021,0.0
NCT05710146,,2022-08-05,,,2023-01-24,2023-01-24,2023-02-02,ACTUAL,,,,,,,2023-01-24,2023-02-02,ACTUAL,2023-12,ESTIMATED,2023-12-31,2023-01,2023-01-31,2024-09,ESTIMATED,2024-09-30,2024-03,ESTIMATED,2024-03-31,,INTERVENTIONAL,,,Tranexamic Acid (TXA) in Hip Arthroscopy,"Assessing the Efficacy of Tranexamic Acid (TXA) in Hip Arthroscopy: A Randomized, Controlled Trial",WITHDRAWN,,PHASE3,0.0,ACTUAL,Northwestern University,,2.0,,Study was never started. Did not receive funding.,f,,,,f,t,f,,,t,,,,,,,,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,OTHER,,,,,,,2024,0.0
NCT05197075,,2022-01-17,,,2023-09-13,2022-01-17,2022-01-19,ACTUAL,,,,,,,2023-09-13,2023-09-14,ACTUAL,2022-08-03,ACTUAL,2022-08-03,2023-09,2023-09-30,2022-09-23,ACTUAL,2022-09-23,2022-09-23,ACTUAL,2022-09-23,,INTERVENTIONAL,,,A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children,A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children Aged >=3 Years and Weighing >=15 kg to <25 kg,COMPLETED,,PHASE1,15.0,ACTUAL,"Janssen Research & Development, LLC",,1.0,,,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,INDUSTRY,,,,,,,2022,0.0
NCT04496167,,2020-07-29,2023-04-14,,2023-08-15,2020-07-29,2020-08-03,ACTUAL,2023-08-15,2023-09-13,ACTUAL,,,,2023-08-15,2023-09-13,ACTUAL,2020-07-29,ACTUAL,2020-07-29,2023-08,2023-08-31,2022-04-14,ACTUAL,2022-04-14,2022-04-14,ACTUAL,2022-04-14,,INTERVENTIONAL,,All randomized participants who received at least 1 injection of study treatment.,Safety and Efficacy of EN3835 in Participants With Frozen Shoulder,"A Phase 2, Randomized, Double Blind, Placebo Controlled Study of the Safety and Efficacy of EN3835 for the Treatment of Adhesive Capsulitis of the Shoulder",COMPLETED,,PHASE2,198.0,ACTUAL,Endo Pharmaceuticals,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,INDUSTRY,,,,,,,2022,1.0
NCT04324463,,2020-03-25,,,2024-01-10,2020-03-25,2020-03-27,ACTUAL,,,,,,,2024-01-10,2024-01-11,ACTUAL,2020-04-21,ACTUAL,2020-04-21,2024-01,2024-01-31,2022-12-30,ACTUAL,2022-12-30,2022-12-30,ACTUAL,2022-12-30,,INTERVENTIONAL,ACTCOVID19,,Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial,"Anti-Coronavirus Therapies to Prevent Progression of COVID-19, a Randomized Trial",COMPLETED,,PHASE3,6667.0,ACTUAL,Population Health Research Institute,,5.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,OTHER,,,,,,,2022,0.0
NCT04002635,,2019-06-27,,,2021-01-06,2019-06-27,2019-06-28,ACTUAL,,,,,,,2021-01-06,2021-01-08,ACTUAL,2020-12-01,ESTIMATED,2020-12-01,2021-01,2021-01-31,2022-04-01,ESTIMATED,2022-04-01,2021-04-01,ESTIMATED,2021-04-01,,INTERVENTIONAL,LEFT,,Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS),Endometrial Preparation Using Letrozole Compared to Artificial Cycle for Frozen Embryo Transfer in PCOS Patients,WITHDRAWN,,PHASE4,0.0,ACTUAL,CRG UZ Brussel,,2.0,,Practical issues,f,,,,t,f,f,,,f,,,,,,YES,"Sharing with other study site, UZ Gent",2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,OTHER,,,,,,,2022,0.0
NCT03359681,,2017-10-10,,,2022-03-02,2017-11-30,2017-12-02,ACTUAL,,,,,,,2022-03-02,2022-03-03,ACTUAL,2018-07-10,ACTUAL,2018-07-10,2021-11,2021-11-30,2021-10-04,ACTUAL,2021-10-04,2021-09-02,ACTUAL,2021-09-02,,INTERVENTIONAL,MECORA,,Metformin Treatment for Colon Cancer,"Perioperative Metformin Treatment for Colon Cancer, a Randomized Trial",COMPLETED,,PHASE2,48.0,ACTUAL,Zealand University Hospital,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,OTHER,,,,,,,2021,1.0
NCT04404140,,2020-05-15,,,2023-10-13,2020-05-26,2020-05-27,ACTUAL,,,,,,,2023-10-13,2023-10-17,ACTUAL,2020-07-09,ACTUAL,2020-07-09,2023-10,2023-10-31,2022-10-14,ACTUAL,2022-10-14,2022-10-14,ACTUAL,2022-10-14,,INTERVENTIONAL,,,"A Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer (mCRPC).","A Phase Ib, Open-Label, Multicenter Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer.",TERMINATED,,PHASE1,6.0,ACTUAL,Hoffmann-La Roche,,1.0,,"Despite many risk-minimization strategies, the combination of ipatasertib, atezolizumab and docetaxel was challenging due to multiple study treatment modifications required to manage toxicity, making further enrollment inappropriate.",f,,,,,t,f,,,,,,,,,,,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,INDUSTRY,,,,,,,2022,0.0
NCT03436121,,2018-01-31,,,2020-02-07,2018-02-09,2018-02-19,ACTUAL,,,,,,,2020-02-07,2020-02-11,ACTUAL,2019-12,ESTIMATED,2019-12-31,2020-02,2020-02-29,2020-02-05,ACTUAL,2020-02-05,2020-02-05,ACTUAL,2020-02-05,,INTERVENTIONAL,,,Single-dose Ketamine for the Reduction of Pain and Depression in the Emergency Department,"Single-dose Ketamine to Reduce Pain Severity, Depressive Symptoms and the Need for Opiates Both During and After Emergency Department Care",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,University of Pittsburgh,,2.0,,Ketamine shortage during the funding period of the trial,f,,,,t,t,f,,,t,,,,,,UNDECIDED,There is no plan in place yet because it is undecided whether the investigators will need to share the data with additional investigators/researchers not listed on the protocol.,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,OTHER,,,,,,,2020,0.0
NCT04447820,,2020-06-19,2023-11-30,2021-12-01,2023-11-30,2020-06-24,2020-06-25,ACTUAL,2023-11-30,2023-12-22,ACTUAL,2021-12-01,2021-12-07,ACTUAL,2023-11-30,2023-12-22,ACTUAL,2020-06-10,ACTUAL,2020-06-10,2023-11,2023-11-30,2020-12-03,ACTUAL,2020-12-03,2020-12-03,ACTUAL,2020-12-03,,INTERVENTIONAL,,The Full Analysis Set (FAS) was defined as all randomized patients who took at least 1 dose of study drug and had a baseline fasting TG assessment.,Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR,"A Multicenter, Randomized, Open-Label, 4-Week Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Once Daily Treatment Compared to K-877-IR Twice Daily Treatment in Adult Patients With Fasting Triglyceride Levels",COMPLETED,,PHASE2,96.0,ACTUAL,"Kowa Research Institute, Inc.",,3.0,,,,,,,f,t,f,,,,,,,,,,,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,INDUSTRY,,,,,,,2020,1.0
NCT02266329,,2014-10-10,2024-05-23,,2024-06-24,2014-10-10,2014-10-17,ESTIMATED,2024-06-24,2024-06-26,ACTUAL,,,,2024-06-24,2024-06-26,ACTUAL,2016-01-04,ACTUAL,2016-01-04,2024-06,2024-06-30,2023-09-30,ACTUAL,2023-09-30,2023-05-31,ACTUAL,2023-05-31,,INTERVENTIONAL,,,Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin,Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin,COMPLETED,,PHASE1/PHASE2,89.0,ACTUAL,VA Office of Research and Development,Change from baseline in headache (HA) frequency (1. Primary Outcome Measure) is based on linear mixed effects regression of outcome on study visit by treatment interaction with study participant as a random effect.,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,FED,,,,,,,2023,1.0
NCT05994547,,2023-07-31,,,2023-08-08,2023-08-08,2023-08-16,ACTUAL,,,,,,,2023-08-08,2023-08-16,ACTUAL,2022-04-14,ACTUAL,2022-04-14,2023-08,2023-08-31,2023-06-15,ACTUAL,2023-06-15,2023-06-15,ACTUAL,2023-06-15,,INTERVENTIONAL,,,Efficacy and Safety of Remimazolam Compared With Midazolam During Bronchoscopy:Randomised Controlled Trial,"Safety and Efficacy of Remimazolam Compared With Midazolam During Bronchoscopy: A Single Center, Randomized Controlled Study",COMPLETED,,PHASE4,100.0,ACTUAL,Chungbuk National University Hospital,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,OTHER,,,,,,,2023,1.0
NCT03056040,,2017-02-14,2019-02-15,,2024-06-27,2017-02-14,2017-02-16,ACTUAL,2019-03-19,2019-03-21,ACTUAL,,,,2024-06-27,2024-07-26,ACTUAL,2017-05-17,ACTUAL,2017-05-17,2024-06,2024-06-30,2022-04-08,ACTUAL,2022-04-08,2022-04-08,ACTUAL,2022-04-08,,INTERVENTIONAL,,All participants who received at least 1 dose of study treatment (ravulizumab or eculizumab).,ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab,"A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab",COMPLETED,,PHASE3,202.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,INDUSTRY,,,,,,,2022,1.0
NCT04193293,,2019-12-04,2023-03-14,,2023-09-07,2019-12-06,2019-12-10,ACTUAL,2023-03-14,2023-04-07,ACTUAL,,,,2023-09-07,2023-09-21,ACTUAL,2020-06-01,ACTUAL,2020-06-01,2023-09,2023-09-30,2020-12-10,ACTUAL,2020-12-10,2020-12-10,ACTUAL,2020-12-10,,INTERVENTIONAL,,"This study was terminated by the Sponsor. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.",A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer,A Phase 1b/2 Study of Duvelisib in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Cancer,TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,SecuraBio,"The study was terminated early by the Sponsor due to low enrollment. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.",1.0,,The study was terminated due to low enrollment.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,INDUSTRY,,,,,,,2020,0.0
NCT03283826,,2017-09-13,,,2024-02-22,2017-09-13,2017-09-14,ACTUAL,,,,,,,2024-02-22,2024-02-23,ACTUAL,2017-10-19,ACTUAL,2017-10-19,2024-02,2024-02-29,2024-01-17,ACTUAL,2024-01-17,2023-11-09,ACTUAL,2023-11-09,,INTERVENTIONAL,EMBOLD,,Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis,"A Phase 1/2, Two-part, Open-label Dose-escalation and Double-blind, Placebo-controlled Dose-expansion Study With an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis",TERMINATED,,PHASE1/PHASE2,134.0,ACTUAL,Atara Biotherapeutics,,2.0,,Study was terminated as primary endpoint was not achieved,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,INDUSTRY,,,,,,,2024,0.0
NCT04753957,,2021-02-09,,,2022-05-24,2021-02-09,2021-02-15,ACTUAL,,,,,,,2022-05-24,2022-05-26,ACTUAL,2022-01-07,ACTUAL,2022-01-07,2022-05,2022-05-31,2022-02-01,ACTUAL,2022-02-01,2022-02-01,ACTUAL,2022-02-01,,INTERVENTIONAL,PiP-2,,Pharmacokinetics of Progesterone in Pregnancy-2,Pharmacokinetics of Progesterone in Pregnancy-2,TERMINATED,,PHASE1,3.0,ACTUAL,Thomas Jefferson University,,2.0,,Difficulty with endometrial sample collection. New study design to be prospective observational to validate reliable methods of endometrial sampling at time of c-section.,f,,,,f,t,f,,,f,,,Following trial completion and publication,Data sharing agreement,,YES,IPD may be requested following trial completion and publication with appropriate data sharing agreement.,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,OTHER,,,,,,,2022,0.0
NCT06029530,,2023-08-24,,,2024-04-12,2023-08-31,2023-09-08,ACTUAL,,,,,,,2024-04-12,2024-04-16,ACTUAL,2024-01-01,ESTIMATED,2024-01-01,2024-04,2024-04-30,2024-08-31,ESTIMATED,2024-08-31,2024-08-31,ESTIMATED,2024-08-31,,INTERVENTIONAL,DONUT,,Delaying the Onset of Nearsightedness Until Treatment Study,Delaying the Onset of Nearsightedness Until Treatment Study,WITHDRAWN,,PHASE1,0.0,ACTUAL,Ohio State University,,3.0,,sIRB determined feasibility study could not be done because of no benefits of the treatment drops in short time violated FDA requirements,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,OTHER,,,,,,,2024,0.0
NCT03666442,,2018-08-18,,,2022-04-28,2018-09-09,2018-09-11,ACTUAL,,,,,,,2022-04-28,2022-04-29,ACTUAL,2018-06-01,ACTUAL,2018-06-01,2022-04,2022-04-30,2022-01-01,ACTUAL,2022-01-01,2020-01-01,ACTUAL,2020-01-01,,INTERVENTIONAL,,,Early Evaluation of Chemosensitivity for Low/Intermediated-risk Mid-low Stage II/III Rectal Cancer,Early Evaluation of Chemosensitivity for Low-risk Stage II/III Rectal Cancer,COMPLETED,,PHASE2,61.0,ACTUAL,West China Hospital,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,OTHER,,,,,,,2022,1.0
NCT04349774,,2020-04-13,,,2022-11-07,2020-04-15,2020-04-16,ACTUAL,,,,,,,2022-11-07,2022-11-14,ACTUAL,2022-10-01,ESTIMATED,2022-10-01,2022-11,2022-11-30,2023-12-30,ESTIMATED,2023-12-30,2023-06-01,ESTIMATED,2023-06-01,,INTERVENTIONAL,,,Erector Spinae Plane Block vs Erector Spinae Plane Block With Serratus Anterior Plane Block in Thoracic Surgery,"A Prospective, Randomized, Double-Blind, Active-Comparator, Pilot Study to Observe Relative Efficacy of Ultrasound-Guided Erector Spinae Plane Block (ESP) vs. Combination of Ultrasound - Guided Erector Spinae Plane Block With Serratus Anterior Plane Block in Managing Post-operative Pain Following Thoracic Surgery.",WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Pittsburgh,,2.0,,Study was never initiated due to COVID-19,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,OTHER,,,,,,,2023,0.0
NCT05222165,,2022-01-12,,,2023-02-21,2022-02-01,2022-02-03,ACTUAL,,,,,,,2023-02-21,2023-02-23,ACTUAL,2021-10-01,ACTUAL,2021-10-01,2023-02,2023-02-28,2022-12-16,ACTUAL,2022-12-16,2022-12-16,ACTUAL,2022-12-16,,INTERVENTIONAL,NEWEL,,Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations,"A Phase 1b/2, Multicenter, Open-Label Study of Oral Infigratinib in Pediatric Subjects With Advanced Solid and Central Nervous System (CNS) Tumors (Phase 1b) and in Subjects With Recurrent or Progressive Low-Grade Gliomas Harboring Selected FGFR1, FGFR2, or FGFR3 Alterations (Phase 2)",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Helsinn Healthcare SA,,1.0,,The company decided to interrupt the development of the drug in all oncological indications,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,INDUSTRY,,,,,,,2022,0.0
NCT03569098,,2018-06-14,2021-05-07,2020-02-28,2021-07-01,2018-06-14,2018-06-26,ACTUAL,2021-07-01,2021-07-02,ACTUAL,2021-07-01,2021-07-02,ACTUAL,2021-07-01,2021-07-02,ACTUAL,2018-06-19,ACTUAL,2018-06-19,2021-07,2021-07-31,2020-05-22,ACTUAL,2020-05-22,2019-12-17,ACTUAL,2019-12-17,,INTERVENTIONAL,DYSTANCE,The Intention-to-Treat (ITT) analysis set included all randomized participants.,Dysport in Hallux Abducto Valgus (HAV) Phase IIa,"A Multiple-dose, Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dysport for the Treatment of Pain Associated With Hallux Abducto Valgus",COMPLETED,,PHASE2,186.0,ACTUAL,Ipsen,Based on the results of the primary analysis the sponsor terminated the study early due to lack of efficacy of the tested doses at the primary endpoint. The decision by the sponsor to terminate the study early was not related to any safety or tolerability concerns with Dysport.,3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,INDUSTRY,,,,,,,2020,1.0
NCT04417036,,2020-05-29,,,2023-04-13,2020-06-02,2020-06-04,ACTUAL,,,,,,,2023-04-13,2023-04-18,ACTUAL,2020-07-07,ACTUAL,2020-07-07,2023-03,2023-03-31,2022-12-28,ACTUAL,2022-12-28,2022-12-28,ACTUAL,2022-12-28,,INTERVENTIONAL,SEAL,,"This Study Collects Information on the Safety of Inhaled Pegylated Adrenomedullin (PEG-ADM), How the Drug is Tolerated and How it Affects Patients Suffering From a Type of Lung Failure That Cause Fluid to Build up in the Lungs Making Breathing Difficult (ARDS)","Safety and Efficacy of Inhaled Pegylated Adrenomedullin (PEG-ADM) in Patients Suffering From Acute Respiratory Distress Syndrome (ARDS): a Double-blind, Randomized, Placebo-controlled, Multicenter Phase 2a/b Clinical Trial",TERMINATED,,PHASE2,90.0,ACTUAL,Bayer,,5.0,,"Terminated (based on Part A results, Bayer decided to not continue investigating BAY 1097761 further in Part B; this was not due to any safety data for BAY 1097761)",f,,,,t,f,f,,,f,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,INDUSTRY,,,,,,,2022,0.0
NCT03127592,,2017-04-17,,,2023-02-07,2017-04-20,2017-04-25,ACTUAL,,,,,,,2023-02-07,2023-02-09,ACTUAL,2020-10-05,ACTUAL,2020-10-05,2023-02,2023-02-28,2022-07-26,ACTUAL,2022-07-26,2022-07-26,ACTUAL,2022-07-26,,INTERVENTIONAL,FDCETCB-III,,Phase III Efficacy and Tolerability Trial of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus Isolated Active Substances in Pain Control After Impacted Third Molar Extraction,"Phase III Randomized, Unicentric, Double-masked, Parallel Trial for the Efficacy and Tolerability of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus the Isolated Active Substances (Flancox® 400 mg And Miosan® 10 mg) in Postoperative Pain Control After Impacted Third Molar Extraction",TERMINATED,,PHASE3,140.0,ACTUAL,Apsen Farmaceutica S.A.,,3.0,,recruitment difficulty,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,INDUSTRY,,,,,,,2022,0.0
NCT01618695,,2012-06-11,2020-05-20,,2021-07-09,2012-06-12,2012-06-13,ESTIMATED,2020-05-20,2020-06-05,ACTUAL,,,,2021-07-09,2021-07-29,ACTUAL,2012-05-15,ACTUAL,2012-05-15,2021-07,2021-07-31,2020-05-28,ACTUAL,2020-05-28,2014-09-15,ACTUAL,2014-09-15,,INTERVENTIONAL,,"Safety Analysis Set (SAS) included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one post-dose safety assessment.",A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures,"A Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures",COMPLETED,,PHASE3,940.0,ACTUAL,Eisai Inc.,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,INDUSTRY,,,,,,,2020,1.0
NCT03428217,,2018-02-05,2023-01-25,2021-08-16,2023-02-21,2018-02-05,2018-02-09,ACTUAL,2023-02-21,2023-03-20,ACTUAL,,2023-03-20,ACTUAL,2023-02-21,2023-03-20,ACTUAL,2018-04-24,ACTUAL,2018-04-24,2023-02,2023-02-28,2021-07-16,ACTUAL,2021-07-16,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,CANTATA,,CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma,"A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC)",COMPLETED,,PHASE2,444.0,ACTUAL,"Calithera Biosciences, Inc",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,INDUSTRY,,,,,,,2021,1.0
NCT04775329,,2021-01-25,,,2023-01-04,2021-02-25,2021-03-01,ACTUAL,,,,,,,2023-01-04,2023-01-06,ACTUAL,2020-11-01,ACTUAL,2020-11-01,2023-01,2023-01-31,2023-01-01,ACTUAL,2023-01-01,2023-01-01,ACTUAL,2023-01-01,,INTERVENTIONAL,SIBOC,,Primary Prophylaxis for Spontaneous Bacterial Peritonitis,Primary Prophylaxis for Spontaneous Bacterial Peritonitis in Decompensated Chronic Liver Disease With Small Bowel Bacterial Overgrowth: A Randomised Trial,TERMINATED,,PHASE2/PHASE3,2.0,ACTUAL,Changi General Hospital,,2.0,,Slow recruitment and study closure,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,OTHER,,,,,,,2023,0.0
NCT04285229,,2020-02-19,2022-05-19,2022-03-10,2023-04-12,2020-02-25,2020-02-26,ACTUAL,2022-06-20,2022-06-28,ACTUAL,2022-06-20,2022-06-28,ACTUAL,2023-04-12,2023-04-14,ACTUAL,2020-04-10,ACTUAL,2020-04-10,2023-04,2023-04-30,2022-03-17,ACTUAL,2022-03-17,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,,All randomized participants,A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis,"A Multicenter, Randomized, Double-Blind and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Chinese Patients With Radiographic Axial Spondyloarthritis",COMPLETED,,PHASE3,147.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,INDUSTRY,,,,,,,2022,1.0
NCT01815736,,2013-03-19,2016-03-15,2014-10-30,2021-03-22,2013-03-19,2013-03-21,ESTIMATED,2016-03-15,2016-04-14,ESTIMATED,2014-10-30,2014-11-05,ESTIMATED,2021-03-22,2021-04-13,ACTUAL,2013-03-27,ACTUAL,2013-03-27,2021-03,2021-03-31,2020-04-01,ACTUAL,2020-04-01,2015-03-16,ACTUAL,2015-03-16,,INTERVENTIONAL,,Safety Analysis Set included participants who were randomized and received at least one dose of study drug.,"Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants","A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects",COMPLETED,,PHASE3,1443.0,ACTUAL,Gilead Sciences,There were no limitations affecting the analysis or results.,2.0,,,f,,,,t,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy",2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,INDUSTRY,,,,,,,2020,1.0
NCT03923361,,2019-04-19,,,2019-12-13,2019-04-19,2019-04-22,ACTUAL,,,,,,,2019-12-13,2019-12-18,ACTUAL,2019-04-16,ACTUAL,2019-04-16,2019-12,2019-12-31,2024-07,ESTIMATED,2024-07-31,2024-03,ESTIMATED,2024-03-31,,INTERVENTIONAL,,,Neural and Antidepressant Effects of Propofol (Phase 2),Neural and Antidepressant Effects of Propofol (Phase 2),WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,University of Utah,,1.0,,Change in study design based on phase 1 data collection; patient burden was not feasible,f,,,,f,f,f,,,,,,,,,,,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,OTHER,,,,,,,2024,0.0
NCT02849743,,2016-07-22,2022-05-04,,2022-09-28,2016-07-26,2016-07-29,ESTIMATED,2022-09-28,2022-10-05,ACTUAL,,,,2022-09-28,2022-10-05,ACTUAL,2016-10,,2016-10-31,2022-09,2022-09-30,2022-05,ACTUAL,2022-05-31,2021-04,ACTUAL,2021-04-30,,INTERVENTIONAL,,,Intranasal Oxytocin in Hypothalamic Obesity,"Intranasal Oxytocin to Promote Weight Loss in Children, Adolescents, and Adults With Brain Tumors and Hypothalamic Obesity Syndrome",COMPLETED,,PHASE2,18.0,ACTUAL,Children's Hospital of Philadelphia,"A new package insert for intranasal oxytocin was released indicating a possible risk for QTc prolongation when administered with other medications known to prolong the QTc. In response with advise from our study cardiologist, we revised exclusion criteria, and added post-dose ECG studies to monitor acute effects. These activities impacted recruitment, as did the COVID-19 pandemic, thus target sample size is less than originally planned (see statistical plan for details).",2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,OTHER,,,,,,,2022,1.0
NCT02263898,,2014-10-08,,,2020-07-23,2014-10-08,2014-10-13,ESTIMATED,,,,,,,2020-07-23,2020-07-27,ACTUAL,2015-01,,2015-01-31,2016-12,2016-12-31,2020-12,ESTIMATED,2020-12-31,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,,,Intermittent LGX818 and MEK162 in Treating Patients With Metastatic Melanoma Who Have BRAFV600 Mutations,Biomarkers of Durable Response With Intermittent Therapy With LGX818 and MEK162 Combined Therapy in Patients With BRAF Mutant Metastatic Melanoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,Jonsson Comprehensive Cancer Center,,1.0,,closed without enrollment,f,,,,t,,,,,,,,,,,,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,OTHER,,,,,,,2020,0.0
NCT01940471,,2013-08-20,2016-12-09,2016-08-23,2023-09-21,2013-09-09,2013-09-12,ESTIMATED,2017-02-10,2017-03-30,ACTUAL,2016-08-23,2016-08-25,ESTIMATED,2023-09-21,2023-10-10,ACTUAL,2013-09-11,ACTUAL,2013-09-11,2023-09,2023-09-30,2022-10-13,ACTUAL,2022-10-13,2015-11-16,ACTUAL,2015-11-16,,INTERVENTIONAL,,Safety Analysis Set: Participants who received at least 1 dose of study drugs.,Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen,"A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Positive, Chronic Hepatitis B",COMPLETED,,PHASE3,875.0,ACTUAL,Gilead Sciences,,3.0,,,f,,,,t,,,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gileadclinicaltrials.com/transparency-policy/,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/",2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,INDUSTRY,,,,,,,2022,1.0
NCT03276962,,2017-09-07,2023-10-31,,2024-05-16,2017-09-07,2017-09-08,ACTUAL,2024-05-16,2024-05-21,ACTUAL,,,,2024-05-16,2024-05-21,ACTUAL,2017-09-28,ACTUAL,2017-09-28,2024-05,2024-05-31,2022-11-14,ACTUAL,2022-11-14,2019-11-04,ACTUAL,2019-11-04,,INTERVENTIONAL,,,"Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age","Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or With-out Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age",COMPLETED,,PHASE2,1500.0,ACTUAL,GlaxoSmithKline,,5.0,,,f,,,,,f,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",https://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,INDUSTRY,,,,,,,2022,1.0
NCT05299359,,2022-03-27,2023-06-06,,2023-11-06,2022-03-27,2022-03-29,ACTUAL,2023-07-07,2023-07-28,ACTUAL,,,,2023-11-06,2023-11-28,ACTUAL,2022-04-15,ACTUAL,2022-04-15,2023-11,2023-11-30,2023-10-18,ACTUAL,2023-10-18,2022-06-11,ACTUAL,2022-06-11,,INTERVENTIONAL,,The safety analysis set included all participants who received at least 1 dose of the treatment.,A Single Heterologous Booster Vaccination Study of TAK-019 in Healthy Japanese Adults (COVID-19),"A Phase 3, Single Arm, Open-Label Trial to Evaluate the Immunogenicity and Safety of a Single Heterologous Booster Vaccination of TAK-019 in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)",COMPLETED,,PHASE3,150.0,ACTUAL,Takeda,,2.0,,,f,,,,f,t,f,,,t,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,INDUSTRY,,,,,,,2023,1.0
NCT01794572,,2013-02-15,,,2021-01-18,2013-02-19,2013-02-20,ESTIMATED,,,,,,,2021-01-18,2021-01-22,ACTUAL,2013-04-24,ACTUAL,2013-04-24,2021-01,2021-01-31,2020-01-07,ACTUAL,2020-01-07,2020-01-07,ACTUAL,2020-01-07,,INTERVENTIONAL,TOMMY,,Phase 1-2 Study of Total Bone Marrow Irradiation With Helicoidal Tomotherapy in 1st Myeloma Relapse,Phase 1-2 Study of the Combination of Escalated Total Bone Marrow Irradiation (TBMI) by Helicoidal Tomotherapy and a Fixed High-dose Melphalan (140 mg/m²) Followed by Peripheral Stem Cell Rescue (PSC) in First Relapsed Multiple Myeloma.,TERMINATED,,PHASE1/PHASE2,13.0,ACTUAL,Institut Cancerologie de l'Ouest,,1.0,,Low patient recruitement rate and modification of the therapeutic standard,f,,,,t,,,,,,,,,,,NO,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,OTHER,,,,,,,2020,0.0
NCT05073679,,2021-07-19,,,2024-06-06,2021-10-04,2021-10-11,ACTUAL,,,,,,,2024-06-06,2024-06-10,ACTUAL,2022-04-22,ACTUAL,2022-04-22,2024-06,2024-06-30,2024-05-21,ACTUAL,2024-05-21,2024-05-21,ACTUAL,2024-05-21,,INTERVENTIONAL,ONPED,,Oral Naltrexone In Pediatric Eating Disorders,A Double-Blind Placebo-Controlled Evaluation of Effectiveness of Oral Naltrexone in Management of Adolescent Eating Disorders,TERMINATED,,PHASE2/PHASE3,10.0,ACTUAL,Milton S. Hershey Medical Center,,2.0,,"Low enrollment numbers, pharmacy not able to acquire sufficient study article component (methylcellulose) due to manufacturer backorder",,,,,t,t,f,,,,,,,,,NO,"No participant data is planned to be shared at the moment to protect patient privacy, as participants are all enrolled in a partial hospitalization program for mental health conditions.",2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,OTHER,,,,,,,2024,0.0
NCT03201458,,2017-06-27,2023-05-11,,2024-03-07,2017-06-27,2017-06-28,ACTUAL,2023-07-10,2023-07-11,ACTUAL,,,,2024-03-07,2024-04-05,ACTUAL,2018-02-08,ACTUAL,2018-02-08,2024-02,2024-02-29,2024-02-19,ACTUAL,2024-02-19,2020-08-07,ACTUAL,2020-08-07,,INTERVENTIONAL,,,Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer,A Randomized Phase 2 Study of Atezolizumab in Combination With Cobimetinib Versus Atezolizumab Monotherapy in Participants With Unresectable Cholangiocarcinoma,COMPLETED,,PHASE2,86.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,NIH,,,,,,,2024,1.0
NCT01316146,,2011-03-04,,,2023-03-17,2011-03-14,2011-03-16,ESTIMATED,,,,,,,2023-03-17,2023-03-22,ACTUAL,2011-10-03,ACTUAL,2011-10-03,2023-03,2023-03-31,2022-05-04,ACTUAL,2022-05-04,2016-01-28,ACTUAL,2016-01-28,,INTERVENTIONAL,,,Administration of T Lymphocytes for Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma (CART CD30),Phase I Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor for Relapsed CD30+ Hodgkin's Lymphoma and CD30+ Non-Hodgkin's Lymphoma (CART CD30),WITHDRAWN,,PHASE1,0.0,ACTUAL,UNC Lineberger Comprehensive Cancer Center,,1.0,,Study never truly opened to accrual at UNC. Study and data were transfered to UNC as the IND for the study was transfered to UNC. IRB closed the study.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:00:27.790631,2024-10-15 16:00:27.790631,OTHER,,,,,,,2022,0.0
NCT03204617,,2017-06-13,,,2021-04-07,2017-06-29,2017-07-02,ACTUAL,,,,,,,2021-04-07,2021-04-08,ACTUAL,2017-07-07,ACTUAL,2017-07-07,2021-04,2021-04-30,2021-03-10,ACTUAL,2021-03-10,2020-07-01,ACTUAL,2020-07-01,,INTERVENTIONAL,,,"Safety and Immunogenicity Study of DNA.HTI, MVA.HTI and ChAdOx1.HTI in HIV-1-positive Patients (AELIX-002)","A Phase I, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability and Immunogenicity Study of Candidate HIV-1 Vaccines DNA.HTI, MVA.HTI and ChAdOx1.HTI in Early Treated HIV-1 Positive Individuals",COMPLETED,,PHASE1,45.0,ACTUAL,Aelix Therapeutics,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,INDUSTRY,,,,,,,2021,0.0
NCT04817332,,2021-01-25,2023-02-20,,2023-08-03,2021-03-25,2021-03-26,ACTUAL,2023-08-03,2023-08-22,ACTUAL,,,,2023-08-03,2023-08-22,ACTUAL,2020-06-05,ACTUAL,2020-06-05,2023-08,2023-08-31,2021-02-28,ACTUAL,2021-02-28,2021-02-28,ACTUAL,2021-02-28,,INTERVENTIONAL,STOP-COVID19,Intention to treat population,STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19,A Randomised Double-blind Placebo-controlled Trial of Brensocatib (INS1007) in Patients With Severe COVID-19,COMPLETED,,PHASE3,406.0,ACTUAL,University of Dundee,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,OTHER,,,,,,,2021,1.0
NCT03369912,,2017-11-28,,,2018-10-05,2017-12-06,2017-12-12,ACTUAL,,,,,,,2018-10-05,2018-10-09,ACTUAL,2018-10-23,ESTIMATED,2018-10-23,2018-10,2018-10-31,2022-11-15,ESTIMATED,2022-11-15,2022-11-15,ESTIMATED,2022-11-15,,INTERVENTIONAL,,,A Study to Evaluate CSJ148 in Pregnant Women With Primary HCMV Infection,"A Multicenter, Randomized, Patient, Investigator and Sponsor Blinded, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of CSJ148 in Pregnant Women With Primary HCMV Infection",WITHDRAWN,,PHASE2,0.0,ACTUAL,Novartis,,2.0,,Company decision to withdraw before study started,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,INDUSTRY,,,,,,,2022,0.0
NCT04640571,,2020-11-09,2023-10-11,,2024-07-15,2020-11-17,2020-11-23,ACTUAL,2024-07-15,2024-07-16,ACTUAL,,,,2024-07-15,2024-07-16,ACTUAL,2021-04-01,ACTUAL,2021-04-01,2024-07,2024-07-31,2021-11-01,ACTUAL,2021-11-01,2021-11-01,ACTUAL,2021-11-01,,INTERVENTIONAL,,Dropped participants did not contribute to the analysis.,Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition,Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition,COMPLETED,,PHASE4,18.0,ACTUAL,"University of Maryland, Baltimore",,6.0,,,f,,,,,t,f,,,f,,,,,,,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,OTHER,,,,,,,2021,1.0
NCT02652260,,2016-01-08,2019-07-16,,2024-02-16,2016-01-08,2016-01-11,ESTIMATED,2019-08-26,2019-08-29,ACTUAL,,,,2024-02-16,2024-02-22,ACTUAL,2016-03-04,ACTUAL,2016-03-04,2024-02,2024-02-29,2024-02-07,ACTUAL,2024-02-07,2018-08-14,ACTUAL,2018-08-14,,INTERVENTIONAL,,,"Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028)","Phase IIb, Double-Blinded, Multicenter, Randomized Study to Assess the Effect on Central Nervous System (CNS) Toxicity of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Subjects.",COMPLETED,,PHASE2,86.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,f,,,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,INDUSTRY,,,,,,,2024,1.0
NCT04745104,,2020-12-01,,,2022-07-11,2021-02-06,2021-02-09,ACTUAL,,,,,,,2022-07-11,2022-07-12,ACTUAL,2021-02-23,ACTUAL,2021-02-23,2022-07,2022-07-31,2022-03-21,ACTUAL,2022-03-21,2022-03-21,ACTUAL,2022-03-21,,INTERVENTIONAL,,,A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects,"A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707 in Healthy Young Adult and Elderly Subjects",COMPLETED,,PHASE1,50.0,ACTUAL,Atridia Pty Ltd.,,6.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,INDUSTRY,,,,,,,2022,1.0
NCT02919072,,2016-08-29,2022-04-20,,2023-11-17,2016-09-27,2016-09-29,ESTIMATED,2023-11-17,2023-11-21,ACTUAL,,,,2023-11-17,2023-11-21,ACTUAL,2016-10,ACTUAL,2016-10-31,2023-11,2023-11-30,2021-06,ACTUAL,2021-06-30,2021-06,ACTUAL,2021-06-30,,INTERVENTIONAL,,,Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section,Comparison of Epidural Chloroprocaine 3% and Ropivacaine 0.75% for Unplanned Caesarean Section in Labouring Women Who Have an Epidural Catheter in Situ,TERMINATED,,PHASE3,16.0,ACTUAL,Sintetica SA,,2.0,,The doctors involved in the study did not enroll any patients,f,,,,f,,,,,,,,,,,,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,INDUSTRY,,,,,,,2021,0.0
NCT05178823,,2021-12-17,,,2022-02-23,2021-12-17,2022-01-05,ACTUAL,,,,,,,2022-02-23,2022-02-24,ACTUAL,2017-06-01,ACTUAL,2017-06-01,2022-02,2022-02-28,2020-09-01,ACTUAL,2020-09-01,2019-09-01,ACTUAL,2019-09-01,,INTERVENTIONAL,,,Short- and Long Term Antibacterial Effects of a Single Rinse With Different Mouthwashes: a Randomized Clinical Trial,Short- and Long Term Antibacterial Effects of a Single Rinse With Different Mouthwashes: a Randomized Clinical Trial,COMPLETED,,PHASE4,171.0,ACTUAL,Semmelweis University,,4.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,OTHER,,,,,,,2020,1.0
NCT04124991,,2019-08-20,,,2023-03-14,2019-10-10,2019-10-14,ACTUAL,,,,,,,2023-03-14,2023-03-16,ACTUAL,2020-06-12,ACTUAL,2020-06-12,2023-03,2023-03-31,2022-07-28,ACTUAL,2022-07-28,2022-07-06,ACTUAL,2022-07-06,,INTERVENTIONAL,SOLID,,Safety and Efficacy Study of Radioembolization in Combination With Durvalumab in Locally Advanced and Unresectable HCC,"A Single-arm, Open-label, Safety and Efficacy Study of Radioembolization With Yttrium-90 Microspheres in Combination With Durvalumab (MEDI4736) in Locally Advanced and Unresectable Hepatocellular Carcinoma (HCC) (SOLID)",COMPLETED,,PHASE1/PHASE2,24.0,ACTUAL,Seoul National University Hospital,,1.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,OTHER,,,,,,,2022,0.0
NCT04255589,,2020-02-03,,,2021-06-30,2020-02-03,2020-02-05,ACTUAL,,,,,,,2021-06-30,2021-07-02,ACTUAL,2020-01-06,ACTUAL,2020-01-06,2021-06,2021-06-30,2021-05-20,ACTUAL,2021-05-20,2021-05-20,ACTUAL,2021-05-20,,INTERVENTIONAL,,,A Clinical Trial to Evaluate the Efficacy and Safety of CKD-495,"A Phase 3, Multi-center, Randomized, Double-blind, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-495 in Patients With Acute and Chronic Gastritis",COMPLETED,,PHASE3,242.0,ACTUAL,Chong Kun Dang Pharmaceutical,,2.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,INDUSTRY,,,,,,,2021,1.0
NCT04126044,,2019-09-26,,,2021-04-23,2019-10-11,2019-10-14,ACTUAL,,,,,,,2021-04-23,2021-04-27,ACTUAL,2021-01-22,ESTIMATED,2021-01-22,2021-04,2021-04-30,2021-07-10,ESTIMATED,2021-07-10,2021-07-10,ESTIMATED,2021-07-10,,INTERVENTIONAL,,,"A SINGLE-DOSE, 2-ARM, PHARMACOKINETIC STUDY OF PF-06439535 (CN) AND EUROPEAN UNION SOURCED BEVACIZUMAB IN CHINESE HEALTHY MALE VOLUNTEERS","A DOUBLE BLIND, RANDOMIZED, PARALLEL-GROUP, SINGLE-DOSE, 2-ARM, COMPARATIVE PHARMACOKINETIC STUDY OF PF-06439535 (CN) AND BEVACIZUMAB SOURCED FROM EUROPEAN UNION ADMINISTERED TO CHINESE HEALTHY MALE VOLUNTEERS",WITHDRAWN,,PHASE1,0.0,ACTUAL,Pfizer,,2.0,,The study was withdrawn prior to enrollment after a comprehensive review of the biosimilars market and the company's global manufacturing network.,f,,,,f,f,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,INDUSTRY,,,,,,,2021,0.0
NCT05057221,,2021-09-23,2023-02-25,,2023-06-16,2021-09-23,2021-09-27,ACTUAL,2023-06-16,2023-07-10,ACTUAL,,,,2023-06-16,2023-07-10,ACTUAL,2021-11-12,ACTUAL,2021-11-12,2023-06,2023-06-30,2022-03-09,ACTUAL,2022-03-09,2022-03-09,ACTUAL,2022-03-09,,INTERVENTIONAL,,Adults with confirmed severe COVID-19 pneumonia (WHO definition) requiring supplemental oxygen,"Safety, Tolerability and Efficacy of Uproleselan (GMI-1271) in Patients With COVID-19 Pneumonia","A Pilot Study to Assess the Safety, Tolerability and Efficacy of Selectin Inhibitor Uproleselan (GMI-1271) in Patients With COVID-19 Pneumonia",TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,University of Michigan,,1.0,,No more eligible patients were available.,f,,,,,t,f,,,,,,,,,NO,,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,OTHER,,,,,,,2022,0.0
NCT03927144,,2019-04-23,2022-09-29,,2023-11-01,2019-04-23,2019-04-25,ACTUAL,2022-10-24,2022-10-25,ACTUAL,,,,2023-11-01,2023-11-18,ACTUAL,2019-05-15,ACTUAL,2019-05-15,2023-10,2023-10-31,2022-09-30,ACTUAL,2022-09-30,2021-10-01,ACTUAL,2021-10-01,,INTERVENTIONAL,,Full Analysis Set (FAS): Included all participants to whom study treatment had been assigned.,Study of Sustained Benefit of AMG334 in Adult Episodic Migraine Patients,"A 12-month Prospective, Randomized, Interventional, Global, Multi-center, Active-controlled Study Comparing Sustained Benefit of Two Treatment Paradigms (AMG334 qm vs. Oral Prophylactics) in Adult Episodic Migraine Patients",COMPLETED,,PHASE4,621.0,ACTUAL,Amgen,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,"Data sharing for this study is the responsibility of Novartis. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,INDUSTRY,,,,,,,2022,1.0
NCT04979442,,2021-07-06,,,2023-10-16,2021-07-16,2021-07-28,ACTUAL,,,,,,,2023-10-16,2023-10-18,ACTUAL,2021-07-14,ACTUAL,2021-07-14,2023-10,2023-10-31,2023-10-01,ACTUAL,2023-10-01,2023-10-01,ACTUAL,2023-10-01,,INTERVENTIONAL,MANTRA,,Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma,A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients With Dedifferentiated Liposarcoma,TERMINATED,,PHASE3,175.0,ACTUAL,Rain Oncology Inc,,2.0,,Sponsor Decision,f,,,,,t,f,,,,,,,,,,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,INDUSTRY,,,,,,,2023,0.0
NCT04121221,,2019-10-08,,,2023-11-30,2019-10-08,2019-10-09,ACTUAL,,,,,,,2023-11-30,2023-12-01,ACTUAL,2019-09-19,ACTUAL,2019-09-19,2023-11,2023-11-30,2023-06-13,ACTUAL,2023-06-13,2023-06-13,ACTUAL,2023-06-13,,INTERVENTIONAL,,,"A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS","A Phase III Study in Subjects With Relapsing Forms of Multiple Sclerosis (RMS) to Asses Efficacy, Safety and Tolerability of GA Depot, a Long Acting IM Injection of Glatiramer Acetate, Once Monthly Compared to Placebo",COMPLETED,,PHASE3,1016.0,ACTUAL,Mapi Pharma Ltd.,,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,INDUSTRY,,,,,,,2023,1.0
NCT03660943,,2018-08-27,2022-03-16,2021-06-09,2022-07-18,2018-09-04,2018-09-07,ACTUAL,2022-07-18,2022-07-21,ACTUAL,2022-07-18,2022-07-21,ACTUAL,2022-07-18,2022-07-21,ACTUAL,2018-09-09,ACTUAL,2018-09-09,2022-07,2022-07-31,2020-06-11,ACTUAL,2020-06-11,2020-06-11,ACTUAL,2020-06-11,,INTERVENTIONAL,,The safety population is defined as any subject that received any amount of investigational product,A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain,"A Randomized, Double-blind, Placebo-controlled, 2-Injection, 52-Week Study to Evaluate the Efficacy and Safety of Intra-articular Injections of CNTX-4975-05 in Subjects With Chronic, Moderate-to-severe Osteoarthritis Knee Pain",COMPLETED,,PHASE3,332.0,ACTUAL,Centrexion Therapeutics,,2.0,,,f,,,,,t,f,,,t,,,,,,,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,INDUSTRY,,,,,,,2020,1.0
NCT04834362,,2021-03-26,2021-09-02,,2021-11-05,2021-04-06,2021-04-08,ACTUAL,2021-11-05,2021-12-06,ACTUAL,,,,2021-11-05,2021-12-06,ACTUAL,2021-04-05,ACTUAL,2021-04-05,2021-11,2021-11-30,2021-06-25,ACTUAL,2021-06-25,2021-06-20,ACTUAL,2021-06-20,,INTERVENTIONAL,,,Insulin for Hyperglycemia in Stroke Trial,"Efficacy and Safety of Human Insulin Versus Analog Insulin in Hospitalized Acute Stroke Patients With Hyperglycemia: a Randomized, Open-label, Single Center Trial",COMPLETED,,PHASE4,452.0,ACTUAL,"National Institute of Neurosciences and Hospital, Dhaka",,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,OTHER_GOV,,,,,,,2021,1.0
NCT02551159,,2015-09-09,2021-07-05,,2021-09-16,2015-09-15,2015-09-16,ESTIMATED,2021-09-16,2021-10-13,ACTUAL,,,,2021-09-16,2021-10-13,ACTUAL,2015-10-15,ACTUAL,2015-10-15,2021-09,2021-09-30,2021-05-21,ACTUAL,2021-05-21,2020-07-06,ACTUAL,2020-07-06,,INTERVENTIONAL,KESTREL,,Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer,"A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination With Tremelimumab Versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients",COMPLETED,,PHASE3,823.0,ACTUAL,AstraZeneca,,3.0,,,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,INDUSTRY,,,,,,,2021,1.0
NCT04311411,,2020-03-16,2023-12-12,,2024-05-21,2020-03-16,2020-03-17,ACTUAL,2024-05-21,2024-05-22,ACTUAL,,,,2024-05-21,2024-05-22,ACTUAL,2020-08-24,ACTUAL,2020-08-24,2024-05,2024-05-31,2022-12-16,ACTUAL,2022-12-16,2022-12-16,ACTUAL,2022-12-16,,INTERVENTIONAL,,All participants who were randomized and received at least 1 dose of study drug.,A Study of Tirzepatide in Overweight and Very Overweight Participants,Effect of Tirzepatide on Energy Intake and Appetite-and Reward-Related Brain Areas in Overweight/Obese Subjects: A Placebo-Controlled 6-Week Study With Functional MRI,COMPLETED,,PHASE1,114.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,INDUSTRY,,,,,,,2022,1.0
NCT03535506,,2018-03-15,,,2024-01-16,2018-05-22,2018-05-24,ACTUAL,,,,,,,2024-01-16,2024-01-18,ACTUAL,2018-10-08,ACTUAL,2018-10-08,2024-01,2024-01-31,2023-12-06,ACTUAL,2023-12-06,2023-12-06,ACTUAL,2023-12-06,,INTERVENTIONAL,WI223281,,Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery,Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery,TERMINATED,,PHASE2,17.0,ACTUAL,Georgetown University,,2.0,,lack of accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:29:26.932079,2024-10-16 12:29:26.932079,OTHER,,,,,,,2023,0.0
NCT02687386,,2016-01-28,,,2022-01-30,2016-02-16,2016-02-22,ESTIMATED,,,,,,,2022-01-30,2022-02-14,ACTUAL,2016-02-08,ACTUAL,2016-02-08,2022-01,2022-01-31,2021-12-29,ACTUAL,2021-12-29,2021-12-29,ACTUAL,2021-12-29,,INTERVENTIONAL,ECREST,,A Study of Intravenous EEDVsMit in Children With Recurrent / Refractory Solid or CNS Tumours Expressing EGFR,A Phase 1 Study of Intravenous EGFR-ErbituxEDVsMIT (EEDVsMit) in Children With Recurrent / Refractory Solid or CNS Tumours Expressing Epidermal Growth Factor Receptor (EGFR) (ECREST Study),TERMINATED,,PHASE1,9.0,ACTUAL,Sydney Children's Hospitals Network,,1.0,,Study medication no longer in production,f,,,,t,,,,,,,,,,,UNDECIDED,De-identified data is planned to be shared with EnGeneIC.,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,OTHER,,,,,,,2021,0.0
NCT03113968,,2017-02-09,2023-06-26,,2023-09-01,2017-04-10,2017-04-14,ACTUAL,2023-07-21,2023-08-09,ACTUAL,,,,2023-09-01,2023-09-28,ACTUAL,2017-04-07,ACTUAL,2017-04-07,2023-09,2023-09-30,2022-11-17,ACTUAL,2022-11-17,2022-10-28,ACTUAL,2022-10-28,,INTERVENTIONAL,ELEKT-D,Intention-to-treat population,ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD),ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD),COMPLETED,,PHASE2/PHASE3,403.0,ACTUAL,The Cleveland Clinic,"Our trial has several limitations. ECT was started with right unilateral placement and was then switched to bilateral placement in the event of inadequate response. The open-label design of our trial could have influenced response. Maintenance treatment was not studied. Other limitations of our trial include a lack of placebo, the flexibility of treatment methods, and a follow-up period during which the patients received treatment as presc",2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,OTHER,,,,,,,2022,1.0
NCT04361552,,2020-04-07,,,2020-06-16,2020-04-22,2020-04-24,ACTUAL,,,,,,,2020-06-16,2020-06-18,ACTUAL,2020-04-07,ACTUAL,2020-04-07,2020-06,2020-06-30,2020-06-02,ACTUAL,2020-06-02,2020-06-02,ACTUAL,2020-06-02,,INTERVENTIONAL,,,Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection),"Tociluzumab for Cytokine Release Syndrome With SARS-CoV-2: An Open-Labeled, Randomized Phase 3 Trial",WITHDRAWN,,PHASE3,0.0,ACTUAL,Emory University,,2.0,,Study abandoned due to drug billing issues,f,,,,t,t,f,,,,,,,,,NO,"Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.",2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,OTHER,,,,,,,2020,0.0
NCT04667468,,2020-11-24,,,2024-06-11,2020-12-07,2020-12-14,ACTUAL,,,,,,,2024-06-11,2024-06-13,ACTUAL,2022-06-21,ACTUAL,2022-06-21,2024-06,2024-06-30,2023-11-20,ACTUAL,2023-11-20,2023-10-07,ACTUAL,2023-10-07,,INTERVENTIONAL,CriSP-HS,,Cold Stored Platelet in Hemorrhagic Shock,Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) Trial,COMPLETED,,PHASE2,200.0,ACTUAL,University of Pittsburgh,,2.0,,,f,,,,t,t,f,,,,,,Data will become available after publication of the primary manuscript.,Requests for data will be submitted in writing and reviewed by the Principal Investigator.,,YES,De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator.,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,OTHER,,,,,,,2023,0.0
NCT04487808,,2020-07-22,,,2023-08-15,2020-07-22,2020-07-27,ACTUAL,,,,,,,2023-08-15,2023-08-18,ACTUAL,2021-05-01,ESTIMATED,2021-05-01,2023-08,2023-08-31,2022-07-01,ESTIMATED,2022-07-01,2022-07-01,ESTIMATED,2022-07-01,,INTERVENTIONAL,,,"Diet Quality, Pecans, and Cardiometabolic Health","Cardiometabolic Effects of Including Pecans as a Snack in Dietary Patterns That Vary in Diet Quality: a Randomized, Controlled Feeding, Crossover Study",WITHDRAWN,,PHASE2,0.0,ACTUAL,Penn State University,,3.0,,The study did not enroll any subjects. It was never started because of the Covid pandemic.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,OTHER,,,,,,,2022,0.0
NCT03989713,,2019-04-12,,,2022-09-12,2019-06-14,2019-06-18,ACTUAL,,,,,,,2022-09-12,2022-09-15,ACTUAL,2020-07-17,ACTUAL,2020-07-17,2022-09,2022-09-30,2022-09-11,ACTUAL,2022-09-11,2022-09-11,ACTUAL,2022-09-11,,INTERVENTIONAL,Q-HAM,,Quizartinib and High-dose Ara-C Plus Mitoxantrone in Relapsed/Refractory AML With FLT3-ITD,Quizartinib and High-dose Ara-C Plus Mitoxantrone in Relapsed/Refractory AML With FLT3-ITD,TERMINATED,,PHASE2,11.0,ACTUAL,University Hospital Heidelberg,,2.0,,Study turned out no longer feasible,f,,,,t,f,f,,,,,,,,,,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,OTHER,,,,,,,2022,0.0
NCT03744637,,2018-11-13,2021-11-24,,2023-01-11,2018-11-13,2018-11-16,ACTUAL,2022-02-22,2022-02-23,ACTUAL,,,,2023-01-11,2023-02-08,ACTUAL,2019-01-18,ACTUAL,2019-01-18,2023-01,2023-01-31,2020-12-11,ACTUAL,2020-12-11,2020-12-11,ACTUAL,2020-12-11,,INTERVENTIONAL,,,A Study of Single Doses of MK -5475 on Pulmonary Vascular Resistance (MK-5475-002),A Study to Assess the Effect of Single Doses of MK -5475 on Pulmonary Vascular Resistance in Patients With Moderate to Severe Pulmonary Arterial Hypertension,COMPLETED,,PHASE1,25.0,ACTUAL,Merck Sharp & Dohme LLC,,5.0,,,f,,,,,f,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-17 01:06:29.990149,2024-10-17 01:06:29.990149,INDUSTRY,,,,,,,2020,1.0
NCT02291289,,2014-11-11,2020-05-28,,2023-11-01,2014-11-11,2014-11-14,ESTIMATED,2020-07-08,2020-07-24,ACTUAL,,,,2023-11-01,2024-05-06,ACTUAL,2015-04-17,ACTUAL,2015-04-17,2023-10,2023-10-31,2021-03-24,ACTUAL,2021-03-24,2019-05-31,ACTUAL,2019-05-31,,INTERVENTIONAL,MODUL,,A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC),A Multi-Centre Randomised Clinical Trial of Biomarker-Driven Maintenance Treatment for First-Line Metastatic Colorectal Cancer (MODUL),COMPLETED,,PHASE2,1044.0,ACTUAL,Hoffmann-La Roche,,13.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,INDUSTRY,,,,,,,2021,1.0
NCT04696848,,2020-12-23,,,2023-04-20,2021-01-04,2021-01-06,ACTUAL,,,,,,,2023-04-20,2023-04-21,ACTUAL,2021-02-24,ACTUAL,2021-02-24,2023-04,2023-04-30,2023-03-09,ACTUAL,2023-03-09,2023-03-09,ACTUAL,2023-03-09,,INTERVENTIONAL,,,The Efficacy and Safety of CKD516 Combined With Durvalumab in Patient Refractory Solid Tumors,A Phase I Study to Determine the Efficacy and Safety of CKD-516 Tablet Combined With Durvalumab(MEDI4736) in Patient Refractory Solid Tumors,TERMINATED,,PHASE1/PHASE2,25.0,ACTUAL,Asan Medical Center,,1.0,,Recruitment difficulty,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,OTHER,,,,,,,2023,0.0
NCT03554161,,2018-04-21,,,2021-03-17,2018-05-30,2018-06-13,ACTUAL,,,,,,,2021-03-17,2021-03-22,ACTUAL,2018-05-10,ACTUAL,2018-05-10,2021-03,2021-03-31,2021-02-01,ACTUAL,2021-02-01,2021-02-01,ACTUAL,2021-02-01,,INTERVENTIONAL,,,Tocilizumab for the Treatment of Refractory Behcet's Uveitis,Efficacy and Safety of Tocilizumab in the Treatment of Refractory Uveitis in Patients With Behcet's Disease,TERMINATED,,PHASE2,3.0,ACTUAL,Peking Union Medical College Hospital,,1.0,,The study was terminated based on its primary and secondary outcome measures in three consecutive patients.,f,,,,f,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,OTHER,,,,,,,2021,0.0
NCT01756040,,2012-12-19,2022-04-30,,2023-11-15,2012-12-21,2012-12-24,ESTIMATED,2023-11-15,2023-11-18,ACTUAL,,,,2023-11-15,2023-11-18,ACTUAL,2013-02-01,ACTUAL,2013-02-01,2023-11,2023-11-30,2021-08-31,ACTUAL,2021-08-31,2021-08-31,ACTUAL,2021-08-31,,INTERVENTIONAL,IPPI,The baseline population is the number of infants enrolled in the study.,Intestinal Permeability in Preterm Infants,Gut Permeability in Very Low Birth Weight Infants,COMPLETED,,PHASE1,211.0,ACTUAL,"University of Maryland, Baltimore",,1.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,OTHER,,,,,,,2021,1.0
NCT03539601,,2018-05-16,2021-12-08,,2021-12-08,2018-05-16,2018-05-29,ACTUAL,2021-12-08,2022-01-10,ACTUAL,,,,2021-12-08,2022-01-10,ACTUAL,2018-04-27,ACTUAL,2018-04-27,2021-12,2021-12-31,2020-12-11,ACTUAL,2020-12-11,2020-12-11,ACTUAL,2020-12-11,,INTERVENTIONAL,,Full analysis set (FAS) included all randomized participants received at least 1 dose of investigational product.,"A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD","A PHASE 3B/4, MULTICENTER, RANDOMIZED, ASSESSOR BLINDED, VEHICLE AND ACTIVE (TOPICAL CORTICOSTEROID AND CALCINEURIN INHIBITOR) CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY, SAFETY, AND LOCAL TOLERABILITY OF CRISABOROLE OINTMENT, 2% IN PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS",TERMINATED,,PHASE4,237.0,ACTUAL,Pfizer,"Study was terminated early by sponsor. Decision was not due to safety/efficacy concerns, but was related to business, portfolio reprioritization. Sub-study planned as per Amendment 3 was not initiated, as sub study site setup didn't complete prior to study termination.",4.0,,This decision was made for business reasons only and is not related to any safety concerns regarding crisaborole.,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,INDUSTRY,,,,,,,2020,0.0
NCT05135650,,2021-11-23,,,2023-06-08,2021-11-23,2021-11-26,ACTUAL,,,,,,,2023-06-08,2023-06-09,ACTUAL,2022-01-25,ACTUAL,2022-01-25,2023-06,2023-06-30,2023-01-10,ACTUAL,2023-01-10,2022-10-18,ACTUAL,2022-10-18,,INTERVENTIONAL,,,"Pharmacokinetics of Sotrovimab as Pre-exposure Prophylaxis for COVID-19 in Hematopoietic Stem Cell Transplant Recipients, COVIDMAB Study",Pharmacokinetics of a SARS-CoV-2 Monoclonal Antibody in Hematopoietic Stem Cell Transplant Recipients (COVIDMAB),TERMINATED,,PHASE1,20.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,Terminated due to FDA withdrawal of the emergency use authorization (EUA) for sotrovimab,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,OTHER,,,,,,,2023,0.0
NCT01946152,,2013-09-16,2021-03-19,,2021-07-09,2013-09-16,2013-09-19,ESTIMATED,2021-07-09,2021-07-30,ACTUAL,,,,2021-07-09,2021-07-30,ACTUAL,2014-03-05,ACTUAL,2014-03-05,2021-07,2021-07-31,2020-03-18,ACTUAL,2020-03-18,2020-03-18,ACTUAL,2020-03-18,,INTERVENTIONAL,,All participants enrolled on the study,"Pomalidomide, Dexamethasone, and Filgrastim-sndz in Treating Patients With Relapsed or Refractory Multiple Myeloma",A Phase I/II Study of Pomalidomide and Dexamethasone With Growth Factor Support in Patients With Relapsed/Refractory Multiple Myeloma,TERMINATED,,PHASE1/PHASE2,21.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Per PI at time of CR,f,,,,f,t,f,,,,,,,,,,,2024-10-15 02:06:14.114214,2024-10-15 02:06:14.114214,OTHER,,,,,,,2020,0.0
NCT04565756,,2020-08-26,,,2023-01-09,2020-09-24,2020-09-25,ACTUAL,,,,,,,2023-01-09,2023-01-10,ACTUAL,2020-11-05,ACTUAL,2020-11-05,2023-01,2023-01-31,2022-11-29,ACTUAL,2022-11-29,2022-10-25,ACTUAL,2022-10-25,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Tolerability of EXN407,"A Randomised, Double-Masked Vehicle-Controlled, Multiple Dose, Dose Escalation Study To Evaluate The Safety and Tolerability of EXN407 in Subjects With Centre Involved Diabetic Macular Oedema Secondary to Diabetes Mellitus",COMPLETED,,PHASE1/PHASE2,48.0,ACTUAL,Exonate Limited,,4.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,INDUSTRY,,,,,,,2022,0.0
NCT05486208,,2022-08-02,,,2024-05-09,2022-08-02,2022-08-03,ACTUAL,,,,,,,2024-05-09,2024-05-10,ACTUAL,2022-08-11,ACTUAL,2022-08-11,2024-05,2024-05-31,2024-01-20,ACTUAL,2024-01-20,2024-01-20,ACTUAL,2024-01-20,,INTERVENTIONAL,,,A Study of LY3844583 in Healthy Participants and Participants With Atopic Dermatitis,"A Phase 1, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Single-Ascending Dose Study of LY3844583 in Healthy Participants, and Multiple-Dose Study of LY3844583 in Healthy Participants and Patients With Atopic Dermatitis",TERMINATED,,PHASE1,102.0,ACTUAL,Eli Lilly and Company,,6.0,,Study terminated due to lack of efficacy signal in atopic dermatitis participants.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,INDUSTRY,,,,,,,2024,0.0
NCT04707157,,2021-01-12,2023-10-09,2023-05-30,2023-10-09,2021-01-12,2021-01-13,ACTUAL,2023-10-09,2023-11-02,ACTUAL,,2023-05-31,ACTUAL,2023-10-09,2023-11-02,ACTUAL,2021-05-06,ACTUAL,2021-05-06,2023-10,2023-10-31,2022-06-13,ACTUAL,2022-06-13,2022-06-13,ACTUAL,2022-06-13,,INTERVENTIONAL,,All enrolled participants.,Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain,"Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3556050 for the Treatment of Diabetic Peripheral Neuropathic Pain",TERMINATED,,PHASE2,68.0,ACTUAL,Eli Lilly and Company,,2.0,,"The trial was slow to enroll, and the sponsor made a business decision to terminate the trial earlier than planned.",f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,INDUSTRY,,,,,,,2022,0.0
NCT03756454,,2018-11-26,,,2023-05-11,2018-11-26,2018-11-28,ACTUAL,,,,,,,2023-05-11,2023-05-12,ACTUAL,2019-08-19,ACTUAL,2019-08-19,2023-05,2023-05-31,2022-05-23,ACTUAL,2022-05-23,2022-05-23,ACTUAL,2022-05-23,,INTERVENTIONAL,,,Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery.,"A Prospective, Double-blind, Randomized, and Controlled Clinical Trial to Compare the Effectiveness of Intravenous Bezlotoxumab (10 mg/kg) Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant Clostridioides Difficile Requiring Surgical Intervention.",TERMINATED,,PHASE4,5.0,ACTUAL,Ohio State University,,2.0,,Difficulties with enrollment and inability to guarantee further study drug supply after current supply expired.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,OTHER,,,,,,,2022,0.0
NCT02102022,,2014-03-28,,,2022-04-18,2014-03-28,2014-04-02,ESTIMATED,,,,,,,2022-04-18,2022-04-25,ACTUAL,2014-11,,2014-11-30,2019-05,2019-05-31,2020-02,ACTUAL,2020-02-29,2020-02,ACTUAL,2020-02-29,,INTERVENTIONAL,,,Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma,Phase 1/2 Study of ADI-PEG 20 Plus FOLFOX in Subjects With Advanced Gastrointestinal Malignancies Focusing on Hepatocellular Carcinoma,TERMINATED,,PHASE1/PHASE2,140.0,ACTUAL,Polaris Group,,1.0,,,f,,,,f,,f,,,,,,,,,,,2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,INDUSTRY,,,,,,,2020,0.0
NCT03423264,,2018-01-26,,,2024-07-29,2018-02-05,2018-02-06,ACTUAL,,,,,,,2024-07-29,2024-07-31,ACTUAL,2018-01-22,ACTUAL,2018-01-22,2024-07,2024-07-31,2022-11-08,ACTUAL,2022-11-08,2022-11-08,ACTUAL,2022-11-08,,INTERVENTIONAL,,,PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing,"A Phase II Randomized Trial of Prophylactic Gabapentin Plus Best Supportive Care Versus Best Supportive Care Alone for Patients Receiving Induction Chemotherapy Followed by Response-Stratified Locoregional Therapy for Locoregionally-Advanced, HPV-Related Oropharyngeal Cancer: An Optima II Secondary Study",WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Chicago,,2.0,,unable to accrue,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,OTHER,,,,,,,2022,0.0
NCT00915681,,2009-06-04,2021-08-31,,2022-03-16,2009-06-05,2009-06-08,ESTIMATED,2022-03-16,2022-04-07,ACTUAL,,,,2022-03-16,2022-04-07,ACTUAL,2009-11-10,ACTUAL,2009-11-10,2022-01,2022-01-31,2020-04-10,ACTUAL,2020-04-10,2020-04-10,ACTUAL,2020-04-10,,INTERVENTIONAL,,"Study was terminated, no analysis performed as data are unavailable for most patients.",Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning,A Phase II Multi-Center Open-Label Clinical Trial to Assess the Prevention of Liver Transplantation and/or Death Among Subjects Treated With Intravenous Silibinin (Legalon® SIL) for Amatoxin Induced Hepatic Failure,TERMINATED,,PHASE2,148.0,ACTUAL,Viatris Inc.,,1.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,INDUSTRY,,,,,,,2020,0.0
NCT05687617,,2023-01-08,,,2024-03-30,2023-01-08,2023-01-18,ACTUAL,,,,,,,2024-03-30,2024-04-02,ACTUAL,2022-12-15,ACTUAL,2022-12-15,2024-03,2024-03-31,2024-03-27,ACTUAL,2024-03-27,2024-03-27,ACTUAL,2024-03-27,,INTERVENTIONAL,,,Near-infrared Imaging With Indocyanine Green for Detection of Peritoneal Metastases for Gastric Adenocarcinoma.,"Diagnostic Value of Intraoperative Near-infrared Imaging With Indocyanine Green for Detection of Peritoneal Metastases During Staging Laparoscopy for Gastric Adenocarcinoma: a Prospective, Multicentric Study.",TERMINATED,,PHASE2,11.0,ACTUAL,Laval University,,1.0,,Recruitment lower than expected and negative results.,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,OTHER,,,,,,,2024,0.0
NCT04030598,,2019-07-22,2022-07-26,,2023-03-30,2019-07-22,2019-07-24,ACTUAL,2022-09-15,2022-09-28,ACTUAL,,,,2023-03-30,2023-04-03,ACTUAL,2020-01-07,ACTUAL,2020-01-07,2023-03,2023-03-31,2021-03-01,ACTUAL,2021-03-01,2021-01-04,ACTUAL,2021-01-04,,INTERVENTIONAL,,The safety population included all enrolled participants who received at least 1 dose of study drug (donidalorsen or placebo).,A Study to Assess the Clinical Efficacy of Donidalorsen (Also Known as IONIS-PKK-LRx and ISIS 721744) in Participants With Hereditary Angioedema,"A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Clinical Efficacy of ISIS 721744, a Second-Generation Ligand-Conjugated Antisense Inhibitor of Prekallikrein, in Patients With Hereditary Angioedema",COMPLETED,,PHASE2,23.0,ACTUAL,"Ionis Pharmaceuticals, Inc.",,3.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,INDUSTRY,,,,,,,2021,1.0
NCT05142228,,2021-10-29,2023-12-15,,2024-03-20,2021-11-19,2021-12-02,ACTUAL,2024-03-20,2024-03-22,ACTUAL,,,,2024-03-20,2024-03-22,ACTUAL,2022-05-31,ACTUAL,2022-05-31,2024-03,2024-03-31,2022-10-27,ACTUAL,2022-10-27,2022-10-27,ACTUAL,2022-10-27,,INTERVENTIONAL,,Participants who completed baseline period and randomization.,Erenumab-aooe for the Management of Trigeminal Neuropathic Pain.,Erenumab as a Therapeutic Approach for the Management of Trigeminal Neuropathic Pain (TNP),TERMINATED,,PHASE2,5.0,ACTUAL,"University of Maryland, Baltimore",Early termination due to low enrollment rate. Ultimately we only had one participant in only one group.,2.0,,Low enrollment rate,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,OTHER,,,,,,,2022,0.0
NCT04355676,,2020-04-17,,,2023-01-19,2020-04-17,2020-04-21,ACTUAL,,,,,,,2023-01-19,2023-01-20,ACTUAL,2020-04-30,ACTUAL,2020-04-30,2023-01,2023-01-31,2020-08-30,ACTUAL,2020-08-30,2020-08-30,ACTUAL,2020-08-30,,INTERVENTIONAL,,,Evaluation of Activity and Safety of Two Regimens of Low Dose Oral Selinexor in Participants With Moderate or Severe COVID-19,"A Phase 2 Randomized, Open-Label, Multicenter Study to Evaluate the Activity and Safety of Two Regimens of Low Dose Oral Selinexor in Patients With Moderate or Severe COVID-19",WITHDRAWN,,PHASE2,0.0,ACTUAL,Karyopharm Therapeutics Inc,,2.0,,No participants enrolled,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,INDUSTRY,,,,,,,2020,0.0
NCT03348826,,2017-11-16,,,2020-09-11,2017-11-16,2017-11-21,ACTUAL,,,,,,,2020-09-11,2020-09-16,ACTUAL,2020-06-01,ESTIMATED,2020-06-01,2020-09,2020-09-30,2021-09-02,ESTIMATED,2021-09-02,2020-09-01,ESTIMATED,2020-09-01,,INTERVENTIONAL,,,Study of Sodium Bicarbonate in Restoring Blocked Catheters,Sodium Bicarbonate Injections for Restoration of Flow in a Central Venous Catheter (CVC/Hickman Catheter) or Peripherally Inserted Central Venous Catheter (PICC),WITHDRAWN,,PHASE2,0.0,ACTUAL,"University Health Network, Toronto",,2.0,,No participants were enrolled,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,OTHER,,,,,,,2021,0.0
NCT05242146,,2022-01-31,,,2023-06-12,2022-02-15,2022-02-16,ACTUAL,,,,,,,2023-06-12,2023-06-13,ACTUAL,2022-05-24,ACTUAL,2022-05-24,2023-06,2023-06-30,2023-05-11,ACTUAL,2023-05-11,2023-05-11,ACTUAL,2023-05-11,,INTERVENTIONAL,STAR CNS,,GB5121 in Adult Patients With Relapsed/Refractory CNS Lymphoma,"A Phase 1b/2, Open-label Dose Escalation With Expansion Study of GB5121 in Adult Patients With Relapsed/Refractory Primary or Secondary Central Nervous System Lymphoma or Primary Vitreoretinal Lymphoma, With a Phase 2 Open-label Single Dose Level Study of GB5121 in Adult Patients With Relapsed/ Refractory Primary Central Nervous System Lymphoma",TERMINATED,,PHASE1,12.0,ACTUAL,Gossamer Bio Inc.,,1.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,INDUSTRY,,,,,,,2023,0.0
NCT02782741,,2016-05-23,2021-03-12,,2024-03-29,2016-05-23,2016-05-25,ESTIMATED,2021-03-12,2021-04-08,ACTUAL,,,,2024-03-29,2024-04-04,ACTUAL,2016-11-02,ACTUAL,2016-11-02,2024-03,2024-03-31,2023-05-31,ACTUAL,2023-05-31,2020-03-19,ACTUAL,2020-03-19,,INTERVENTIONAL,COMET,Analysis was performed on modified intent-to-treat (mITT) population which included all randomized participants who had received at least 1 infusion (partial or total) and were analyzed according to the treatment arm allocated by randomization.,Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies Avalglucosidase Alfa and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease,"A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Safety of Repeated Biweekly Infusions of Avalglucosidase Alfa (neoGAA, GZ402666) and Alglucosidase Alfa in Treatment naïve Patients With Late-onset Pompe Disease",COMPLETED,,PHASE3,101.0,ACTUAL,Sanofi,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,INDUSTRY,,,,,,,2023,1.0
NCT03448068,,2018-02-09,2021-03-08,,2021-04-05,2018-02-26,2018-02-27,ACTUAL,2021-04-05,2021-04-29,ACTUAL,,,,2021-04-05,2021-04-29,ACTUAL,2018-04-16,ACTUAL,2018-04-16,2021-04,2021-04-30,2020-01-09,ACTUAL,2020-01-09,2020-01-09,ACTUAL,2020-01-09,,INTERVENTIONAL,,,Perioperative Ketamine for Pain With Gastric Bypass,Low-dose Ketamine Infusions for Perioperative Pain Management in Patients Undergoing Laparoscopic Gastric Bypass,COMPLETED,,PHASE2,34.0,ACTUAL,Mayo Clinic,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,OTHER,,,,,,,2020,1.0
NCT01625286,,2012-05-10,2018-04-25,,2022-12-23,2012-06-19,2012-06-21,ESTIMATED,2019-01-02,2019-04-01,ACTUAL,,,,2022-12-23,2023-01-18,ACTUAL,2012-10-03,ACTUAL,2012-10-03,2022-12,2022-12-31,2022-10-03,ACTUAL,2022-10-03,2017-01-28,ACTUAL,2017-01-28,,INTERVENTIONAL,BEECH,All patients with data who were included in the full analysis set for Part A and the intention to treat analysis set in Part B',"Investigating Safety, Tolerability and Efficacy of AZD5363 When Combined With Paclitaxel in Breast Cancer Patients",A Phase I/II Study of AZD5363 Combined With Paclitaxel in Patients With Advanced or Metastatic Breast Cancer. Comprising a Safety Run-In and a Placebo-controlled Randomised Expansion in ER+ve Patients Stratified by PIK3CA Mutation Status,COMPLETED,,PHASE1/PHASE2,148.0,ACTUAL,AstraZeneca,"QoL, PK/PD \& efficacy response modelling were considered non-key secondary endpoints and not disclosed at this time. QoL data was limited and considered exploratory, PK/PD and modelling were not reported in CSR. Diarrhoea burden is reported with AEs",4.0,,,f,,,,t,,,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared",2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,INDUSTRY,,,,,,,2022,1.0
NCT05662332,,2022-12-15,,,2024-07-24,2022-12-21,2022-12-22,ACTUAL,,,,,,,2024-07-24,2024-07-25,ACTUAL,2023-01-14,ACTUAL,2023-01-14,2024-07,2024-07-31,2024-07-17,ACTUAL,2024-07-17,2024-07-17,ACTUAL,2024-07-17,,INTERVENTIONAL,QWINT-1,,A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1),"A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 Administered Weekly Using a Fixed Dose Escalation Compared to Insulin Glargine in Insulin-Naïve Adults With Type 2 Diabetes",COMPLETED,,PHASE3,795.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the United States (US) and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,INDUSTRY,,,,,,,2024,1.0
NCT05313009,,2022-02-14,,,2024-01-16,2022-03-28,2022-04-06,ACTUAL,,,,,,,2024-01-16,2024-01-18,ACTUAL,2022-03-07,ACTUAL,2022-03-07,2024-01,2024-01-31,2023-12-31,ACTUAL,2023-12-31,2023-07-07,ACTUAL,2023-07-07,,INTERVENTIONAL,,,Tarlox and Sotorasib in Patients With KRAS G12C Mutations,A Phase Ib / II Trial of Tarloxotinib and Sotorasib in Patients With KRAS G12C Mutations,TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,Medical University of South Carolina,,2.0,,Study drug was discontinued by manufacturer for business reasons.,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,OTHER,,,,,,,2023,0.0
NCT05171920,,2021-12-22,,,2022-03-18,2021-12-22,2021-12-29,ACTUAL,,,,,,,2022-03-18,2022-03-31,ACTUAL,2022-01-24,ACTUAL,2022-01-24,2022-02,2022-02-28,2022-07,ESTIMATED,2022-07-31,2022-07,ESTIMATED,2022-07-31,,INTERVENTIONAL,CARDEA-Plus,,A Placebo-Controlled Study of Auxora for the Extended Treatment of High- Risk Patients With Critical COVID-19 Pneumonia,A Placebo-Controlled Study of Auxora for the Extended Treatment of High- Risk Patients With Critical COVID-19 Pneumonia (CARDEA-Plus),WITHDRAWN,,PHASE2,0.0,ACTUAL,"CalciMedica, Inc.",,2.0,,lack of sufficient numbers of critically ill patients to enroll the study,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,INDUSTRY,,,,,,,2022,0.0
NCT03805360,,2019-01-10,,,2020-08-05,2019-01-14,2019-01-15,ACTUAL,,,,,,,2020-08-05,2020-08-07,ACTUAL,2019-05-24,ACTUAL,2019-05-24,2020-08,2020-08-31,2020-01-10,ACTUAL,2020-01-10,2020-01-10,ACTUAL,2020-01-10,,INTERVENTIONAL,,,The Erector Spinae Plane Block and Its Effect on Respiratory Status and Pain Management in Rib Fracture Patients,The Erector Spinae Plane Block and Its Effect on Respiratory Status and Pain Management in Rib Fracture Patients,TERMINATED,,PHASE1,4.0,ACTUAL,Virginia Commonwealth University,,2.0,,Insufficient enrollment,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 16:06:26.290009,2024-10-15 16:06:26.290009,OTHER,,,,,,,2020,0.0
NCT02994433,,2016-12-02,,,2021-07-29,2016-12-12,2016-12-15,ESTIMATED,,,,,,,2021-07-29,2021-08-02,ACTUAL,2017-01-27,ACTUAL,2017-01-27,2021-07,2021-07-31,2020-02-28,ACTUAL,2020-02-28,2020-02-28,ACTUAL,2020-02-28,,INTERVENTIONAL,,,NMDA Receptor Antagonist Nitrous Oxide Targets Affective Brain Circuits,NMDA Receptor Antagonist Nitrous Oxide Targets Affective Brain Circuits,TERMINATED,,PHASE1,49.0,ACTUAL,Washington University School of Medicine,,2.0,,remaining visits and enrollment terminated due to the pandemic,f,,,,t,t,f,,,,,,,,,,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,OTHER,,,,,,,2020,0.0
NCT05116917,,2021-10-23,,,2024-05-24,2021-11-02,2021-11-11,ACTUAL,,,,,,,2024-05-24,2024-05-28,ACTUAL,2021-11-05,ACTUAL,2021-11-05,2024-05,2024-05-31,2023-10-19,ACTUAL,2023-10-19,2023-10-19,ACTUAL,2023-10-19,,INTERVENTIONAL,INFLUENCE,,Immunotherapy Combined With Radiation and Influenza Vaccine for Pancreatic Cancer.,"Nivolumab, Ipilimumab and Radiation in Combination With Influenza Vaccine in Patients With Pancreatic Cancer (INFLUENCE)",TERMINATED,,PHASE2,19.0,ACTUAL,Herlev Hospital,,1.0,,Based on the precpecified interim analysis the predictive probability was below 10% for the prespecified endpoint.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,OTHER,,,,,,,2023,0.0
NCT03498313,,2018-04-06,2022-06-13,,2022-08-18,2018-04-06,2018-04-13,ACTUAL,2022-08-18,2022-09-14,ACTUAL,,,,2022-08-18,2022-09-14,ACTUAL,2018-07-27,ACTUAL,2018-07-27,2022-08,2022-08-31,2021-05-09,ACTUAL,2021-05-09,2021-05-09,ACTUAL,2021-05-09,,INTERVENTIONAL,CLEAR-2,,Unique Effects of Perimenstrual Estradiol or Progesterone Supplementation on Perimenstrual Suicidality,Unique Effects of Perimenstrual Estradiol or Progesterone Supplementation on Perimenstrual Suicidality,COMPLETED,,PHASE4,60.0,ACTUAL,University of Illinois at Chicago,,3.0,,,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,OTHER,,,,,,,2021,1.0
NCT03612466,,2018-07-30,,,2022-10-13,2018-08-01,2018-08-02,ACTUAL,,,,,,,2022-10-13,2022-10-14,ACTUAL,2022-08,ESTIMATED,2022-08-31,2022-10,2022-10-31,2024-09,ESTIMATED,2024-09-30,2023-01,ESTIMATED,2023-01-31,,INTERVENTIONAL,,,A Dose Finding Study of CycloSam® Combined With External Beam Radiotherapy,A Dose Finding Study of CycloSam® (153Sm-DOTMP) Combined With External Beam Radiotherapy to Treat High Risk Osteosarcoma and Other Solid Tumors Metastatic to Bone,WITHDRAWN,,PHASE1,0.0,ACTUAL,Albert Einstein College of Medicine,,1.0,,Study withdrawn before any participants could be enrolled. Issues being able to effectively recruit participants into the study.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,OTHER,,,,,,,2024,0.0
NCT02056574,,2014-02-04,,,2015-08-03,2014-02-05,2014-02-06,ESTIMATED,,,,,,,2015-08-03,2015-08-04,ESTIMATED,2015-11,,2015-11-30,2015-03,2015-03-31,2020-04,ESTIMATED,2020-04-30,2019-11,ESTIMATED,2019-11-30,,INTERVENTIONAL,ENACT-2,,Safety and Efficacy Study of a Single Dose of NA-1 in Patients Undergoing Endovascular Repair of Ruptured Aneurysms,"Phase 2, Multicenter Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study Evaluating a Single Dose of Intravenous NA-1 in Patients With Subarachnoid Hemorrhage Undergoing Endovascular Repair of Ruptured Intracranial Aneurysms",WITHDRAWN,,PHASE2,0.0,ACTUAL,NoNO Inc.,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,INDUSTRY,,,,,,,2020,0.0
NCT02614859,,2015-11-18,2022-02-02,,2022-03-02,2015-11-23,2015-11-25,ESTIMATED,2022-03-02,2022-03-29,ACTUAL,,,,2022-03-02,2022-03-29,ACTUAL,2015-12-01,ACTUAL,2015-12-01,2022-03,2022-03-31,2020-01-24,ACTUAL,2020-01-24,2020-01-24,ACTUAL,2020-01-24,,INTERVENTIONAL,BIMET-1,Participant in metformin and bicalutamide arm removed from study due to non-compliance,Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients,Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients (BIMET-1),COMPLETED,,PHASE2,29.0,ACTUAL,Fox Chase Cancer Center,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,OTHER,,,,,,,2020,0.0
NCT05288283,,2022-03-11,,,2023-11-01,2022-03-11,2022-03-21,ACTUAL,,,,,,,2023-11-01,2023-11-02,ACTUAL,2022-10-31,ACTUAL,2022-10-31,2023-11,2023-11-30,2023-09-28,ACTUAL,2023-09-28,2023-09-28,ACTUAL,2023-09-28,,INTERVENTIONAL,,,Efficacy and Safety of GWP42003-P Oral Solution in Children With Epilepsy With Myoclonic-atonic Seizures,"A Randomized, Double-blind, Placebo-controlled, Multisite, Phase 3 Study to Investigate the Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P) in Children and Adolescents With Epilepsy With Myoclonic-Atonic Seizures",TERMINATED,,PHASE3,3.0,ACTUAL,Jazz Pharmaceuticals,,2.0,,The study was terminated due to a business decision.,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 03:13:23.941087,2024-10-16 03:13:23.941087,INDUSTRY,,,,,,,2023,0.0
NCT02635061,,2015-12-14,,,2024-05-06,2015-12-16,2015-12-18,ESTIMATED,,,,,,,2024-05-06,2024-05-07,ACTUAL,2016-08-25,ACTUAL,2016-08-25,2024-05,2024-05-31,2024-01-22,ACTUAL,2024-01-22,2024-01-22,ACTUAL,2024-01-22,,INTERVENTIONAL,,,Selective HDAC6 Inhibitor ACY 241 in Combination With Nivolumab in Patients With Unresectable Non Small Cell Lung Cancer,A Phase 1b Study of the Selective HDAC6 Inhibitor ACY-241 in Combination With Nivolumab in Patients With Unresectable Non-Small Cell Lung Cancer,TERMINATED,,PHASE1,17.0,ACTUAL,Celgene,,1.0,,Lack of efficacy,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 16:12:55.915477,2024-10-15 16:12:55.915477,INDUSTRY,,,,,,,2024,0.0
NCT03951623,,2019-05-14,,,2024-07-15,2019-05-14,2019-05-15,ACTUAL,,,,,,,2024-07-15,2024-07-16,ACTUAL,2019-08-12,ACTUAL,2019-08-12,2024-07,2024-07-31,2022-07-31,ACTUAL,2022-07-31,2021-10-30,ACTUAL,2021-10-30,,INTERVENTIONAL,,,"The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523 in Immune Thrombocytopenia Patients","The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523, a Syk Inhibitor in Adult Patients of Immune Thrombocytopenia: a Randomized, Double Blinded, Placebo Controlled Phase Ib Study",COMPLETED,,PHASE1,45.0,ACTUAL,Hutchmed,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,INDUSTRY,,,,,,,2022,1.0
NCT04449965,,2020-06-24,,,2022-07-07,2020-06-25,2020-06-29,ACTUAL,,,,,,,2022-07-07,2022-07-11,ACTUAL,2021-01-19,ACTUAL,2021-01-19,2022-07,2022-07-31,2021-08-16,ACTUAL,2021-08-16,2021-08-16,ACTUAL,2021-08-16,,INTERVENTIONAL,,,Povidone-Iodine Rinses in the Management of COVID-19,The Efficacy of Topical Povidone-Iodine Rinses in the Management of the Coronavirus Disease 2019 (COVID-19),TERMINATED,,EARLY_PHASE1,5.0,ACTUAL,"St. Paul's Hospital, Canada",,3.0,,The site struggled with patient recruitment as we were not able to reach patients with COVID-19,f,,,,f,f,f,,,f,,,,,,,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,OTHER,,,,,,,2021,0.0
NCT04046146,,2019-07-23,,,2020-09-03,2019-08-02,2019-08-06,ACTUAL,,,,,,,2020-09-03,2020-09-04,ACTUAL,2019-12-15,ACTUAL,2019-12-15,2020-09,2020-09-30,2020-03-15,ACTUAL,2020-03-15,2020-03-15,ACTUAL,2020-03-15,,INTERVENTIONAL,NIR-ICG MRL,,Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport,Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport,COMPLETED,,PHASE1,2.0,ACTUAL,University of Rochester,,1.0,,,f,,,,f,t,f,,,,,,,,,YES,Information of any type may be shared with researchers at other institutions. Subjects will be made aware of this in the informed consent form.,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,OTHER,,,,,,,2020,0.0
NCT03389893,,2017-12-27,2021-04-02,,2021-09-07,2017-12-27,2018-01-04,ACTUAL,2021-05-18,2021-06-14,ACTUAL,,,,2021-09-07,2021-10-04,ACTUAL,2018-07-25,ACTUAL,2018-07-25,2021-09,2021-09-30,2020-09-09,ACTUAL,2020-09-09,2020-04-03,ACTUAL,2020-04-03,,INTERVENTIONAL,,Modified intent-to-treat (mITT): All participants who were randomized and have Staphylococcus aureus (S. aureus) abundance measured at Day 0 and Day 28.,Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis,"Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis, Dupilumab Study",TERMINATED,,PHASE4,72.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),One randomized participant did not meet criteria to be in the modified intent-to-treat (mITT) population because they withdrew prior to Day 28. Ten participants had 23 modified visits due to the coronavirus disease 2019 (COVID-19) pandemic.,2.0,,Due to inability to meet accrual goals within the funding period.,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 16:12:55.915477,2024-10-15 16:12:55.915477,NIH,,,,,,,2020,0.0
NCT04679194,,2020-12-14,,,2023-06-14,2020-12-17,2020-12-22,ACTUAL,,,,,,,2023-06-14,2023-06-18,ACTUAL,2020-12-08,ACTUAL,2020-12-08,2023-06,2023-06-30,2023-03-28,ACTUAL,2023-03-28,2023-03-28,ACTUAL,2023-03-28,,INTERVENTIONAL,,,Study of Mana 312 (Multi Tumor-Associated Antigen T Cells) in Adults With AML/MDS After HSCT,Ph 1 Study of Escalating Single & Multiple Doses of Mana 312 (Multi Tumor-Associated Antigen T Cells) Administered to Adult Subjects With Acute Myeloid Leukemia or Myelodysplastic Syndrome After Allogeneic Hematopoietic Stem Cell Transplant,TERMINATED,,PHASE1,11.0,ACTUAL,Mana Therapeutics,,1.0,,Product manufacturing,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,INDUSTRY,,,,,,,2023,0.0
NCT04575558,,2020-05-18,,,2020-10-02,2020-10-02,2020-10-05,ACTUAL,,,,,,,2020-10-02,2020-10-05,ACTUAL,2020-06-30,ESTIMATED,2020-06-30,2020-10,2020-10-31,2020-10-30,ESTIMATED,2020-10-30,2020-09-01,ESTIMATED,2020-09-01,,INTERVENTIONAL,HOPE_BRAZIL,,HOPE: A Trial of Hydroxichloroquine Plus Azithromycin in High Risk COVID-19,"A Randomized, Multi-institutional, Phase 2 Study of Hydroxichloroquine Plus Azithromycin for High Risk SARS-CoV-2 Positive Patients (COVID-19)",WITHDRAWN,,PHASE2,0.0,ACTUAL,Latin American Cooperative Oncology Group,,2.0,,Withdrawn due to lack of study centers interested in participating.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,OTHER,,,,,,,2020,0.0
NCT04493099,,2020-07-27,,,2020-11-09,2020-07-27,2020-07-30,ACTUAL,,,,,,,2020-11-09,2020-11-12,ACTUAL,2020-10,ESTIMATED,2020-10-31,2020-11,2020-11-30,2020-10-12,ACTUAL,2020-10-12,2020-10-12,ACTUAL,2020-10-12,,INTERVENTIONAL,,,Alvocidib in Combination With Decitabine and Venetoclax in Patients With Relapsed or Refractory AML or as Frontline Therapy in Unfit Patients With AML,A Phase 1/2 Study of Alvocidib in Combination With Decitabine and Venetoclax in Patients With Relapsed or Refractory AML or as Frontline Therapy in Unfit Patients With AML,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,The original sponsor was acquired by a new company and has elected to end funding for all Investigator Sponsored Trials (ISTs),f,,,,f,t,f,,,,,,,,,,,2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,OTHER,,,,,,,2020,0.0
NCT05155020,,2021-12-01,,,2022-10-10,2021-12-01,2021-12-13,ACTUAL,,,,,,,2022-10-10,2022-10-12,ACTUAL,2022-02-11,ACTUAL,2022-02-11,2022-10,2022-10-31,2022-08-05,ACTUAL,2022-08-05,2022-08-05,ACTUAL,2022-08-05,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma,"A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma",TERMINATED,,PHASE2,1.0,ACTUAL,Akeso,,4.0,,The clinical development strategy has been changed,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,INDUSTRY,,,,,,,2022,0.0
NCT04922021,,2021-06-07,2023-06-02,,2023-07-03,2021-06-07,2021-06-10,ACTUAL,2023-07-03,2023-07-24,ACTUAL,,,,2023-07-03,2023-07-24,ACTUAL,2021-07-14,ACTUAL,2021-07-14,2023-07,2023-07-31,2022-09-26,ACTUAL,2022-09-26,2022-06-02,ACTUAL,2022-06-02,,INTERVENTIONAL,,,An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis.,"A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multi-site, Proof of Concept Trial to Evaluate the Efficacy and Safety of LEO 138559 in Adult Subjects With Moderate to Severe Atopic Dermatitis (AD).",COMPLETED,,PHASE2,58.0,ACTUAL,LEO Pharma,,2.0,,,f,,,,f,t,f,,,,,,Data are available to request after results of the trial are available on leopharmatrials.com.,Data sharing is subject to approved scientifically sound research proposal and signed data sharing agreement.,http://leopharmatrials.com/for-professionals,YES,De-identified IPD can be made available to researchers in a closed environment for a specified period of time.,2024-10-15 16:12:55.915477,2024-10-15 16:12:55.915477,INDUSTRY,,,,,,,2022,1.0
NCT05121948,,2021-11-05,,,2024-03-06,2021-11-05,2021-11-16,ACTUAL,,,,,,,2024-03-06,2024-03-08,ACTUAL,2022-02-23,ACTUAL,2022-02-23,2024-03,2024-03-31,2024-03-01,ACTUAL,2024-03-01,2024-02-09,ACTUAL,2024-02-09,,INTERVENTIONAL,,,A Study of HC-7366 to Establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D),"A Multicenter, Open-label, Phase 1a/b Study of HC-7366 in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,35.0,ACTUAL,"HiberCell, Inc.",,8.0,,sponsor decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,INDUSTRY,,,,,,,2024,0.0
NCT04369365,,2020-04-27,,,2022-04-06,2020-04-29,2020-04-30,ACTUAL,,,,,,,2022-04-06,2022-04-07,ACTUAL,2020-04-27,ACTUAL,2020-04-27,2022-04,2022-04-30,2021-06-15,ACTUAL,2021-06-15,2021-06-15,ACTUAL,2021-06-15,,INTERVENTIONAL,,,"A Single-blinded, Randomized, Placebo Controlled Phase II Trial of Prophylactic Treatment With Oral Azithromycin Versus Placebo in Cancer Patients Undergoing Antineoplastic Treatment During the Corona Virus Disease 19 (COVID-19) Pandemic","A Single-blinded, Randomized, Placebo Controlled Phase II Trial of Prophylactic Treatment With Oral Azithromycin Versus Placebo in Cancer Patients Undergoing Antineoplastic Treatment During the Corona Virus Disease 19 (COVID-19) Pandemic",COMPLETED,,PHASE2,74.0,ACTUAL,Medical University of Vienna,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,OTHER,,,,,,,2021,1.0
NCT03816553,,2019-01-13,,,2023-04-08,2019-01-24,2019-01-25,ACTUAL,,,,,,,2023-04-08,2023-04-11,ACTUAL,2019-01-19,ACTUAL,2019-01-19,2023-04,2023-04-30,2022-08-31,ACTUAL,2022-08-31,2020-04-30,ACTUAL,2020-04-30,,INTERVENTIONAL,,,"SHR-1210 in Combination With Apatinib in Patients With Metastatic, Persistent, or Recurrent Cervical Cancer","SHR-1210, a Novel Anti-pd-1 Antibody, in Combination With Apatinib in Patients With Metastatic, Persistent, or Recurrent Cervical Cancer: a Single-arm, Open Label, Multi-center, Phase II Study",COMPLETED,,PHASE2,45.0,ACTUAL,Sun Yat-sen University,,1.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,OTHER,,,,,,,2022,1.0
NCT03266900,,2017-08-09,,,2022-04-12,2017-08-25,2017-08-30,ACTUAL,,,,,,,2022-04-12,2022-04-20,ACTUAL,2017-11-16,ACTUAL,2017-11-16,2022-04,2022-04-30,2021-10-04,ACTUAL,2021-10-04,2021-10-04,ACTUAL,2021-10-04,,INTERVENTIONAL,RESECT,,A Superiority Trial to Compare Re-resection of High-grade T1 Bladder Urothelial Carcinoma to no Re-resection for Improving Progression Free Survival,"A Pilot, Single-centre, Randomized, 5-year, Parallel-group, Superiority Trial to Compare Re-resection of High-grade T1 Bladder Urothelial Carcinoma to no Re-resection for Improving Progression Free Survival",TERMINATED,,EARLY_PHASE1,2.0,ACTUAL,"University Health Network, Toronto",,2.0,,Difficulties with accrual,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,OTHER,,,,,,,2021,0.0
NCT03961815,,2019-05-08,,,2023-10-19,2019-05-21,2019-05-23,ACTUAL,,,,,,,2023-10-19,2023-10-23,ACTUAL,2020-01-06,ACTUAL,2020-01-06,2023-10,2023-10-31,2023-09-19,ACTUAL,2023-09-19,2023-09-19,ACTUAL,2023-09-19,,INTERVENTIONAL,INTREPID OLE,,Open-label Extension Study of Brazikumab in Crohn's Disease,"An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID OLE)",TERMINATED,,PHASE3,18.0,ACTUAL,AstraZeneca,,2.0,,Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,INDUSTRY,,,,,,,2023,0.0
NCT02033993,,2014-01-09,2019-02-21,,2023-08-03,2014-01-09,2014-01-13,ESTIMATED,2020-01-08,2020-01-18,ACTUAL,,,,2023-08-03,2023-08-22,ACTUAL,2014-03-11,ACTUAL,2014-03-11,2020-10,2020-10-31,2020-10-28,ACTUAL,2020-10-28,2018-05-03,ACTUAL,2018-05-03,,INTERVENTIONAL,,ITT,Nab-Paclitaxel to Paclitaxel in Advanced Urothelial Cancer Progressing on or After Platinum Containing Regimen.,A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients With Advanced Urothelial Cancer Progressing on or After a Platinum Containing Regimen.,COMPLETED,,PHASE2,199.0,ACTUAL,Canadian Cancer Trials Group,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 16:12:55.915477,2024-10-15 16:12:55.915477,NETWORK,,,,,,,2020,1.0
NCT03912220,,2019-04-09,2024-04-15,,2024-06-10,2019-04-09,2019-04-11,ACTUAL,2024-06-05,2024-06-06,ACTUAL,,,,2024-06-10,2024-06-12,ACTUAL,2020-09-01,ACTUAL,2020-09-01,2024-06,2024-06-30,2023-05-30,ACTUAL,2023-05-30,2023-05-01,ACTUAL,2023-05-01,,INTERVENTIONAL,,,Evaluation of Nicotinamide Riboside in Prevention of Small Fiber Axon Degeneration and Promotion of Nerve Regeneration,Evaluation of Nicotinamide Riboside in Prevention of Small Fiber Axon Degeneration and Promotion of Nerve Regeneration,COMPLETED,,PHASE2,45.0,ACTUAL,Johns Hopkins University,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 16:12:55.915477,2024-10-15 16:12:55.915477,OTHER,,,,,,,2023,1.0
NCT03284424,,2017-09-14,2021-09-14,2021-07-14,2024-07-29,2017-09-14,2017-09-15,ACTUAL,2021-10-21,2021-11-19,ACTUAL,2021-10-21,2021-11-19,ACTUAL,2024-07-29,2024-08-23,ACTUAL,2017-10-26,ACTUAL,2017-10-26,2024-07,2024-07-31,2023-09-13,ACTUAL,2023-09-13,2020-07-29,ACTUAL,2020-07-29,,INTERVENTIONAL,,The analysis population consisted of all participants who received ≥1 dose of study treatment.,Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629),"A Phase 2, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab in Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC)",COMPLETED,,PHASE2,159.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,INDUSTRY,,,,,,,2023,1.0
NCT03110354,,2017-03-31,2023-03-27,,2024-01-29,2017-04-06,2017-04-12,ACTUAL,2024-01-26,2024-01-30,ACTUAL,,,,2024-01-29,2024-01-31,ACTUAL,2017-04-05,ACTUAL,2017-04-05,2024-01,2024-01-31,2021-03-09,ACTUAL,2021-03-09,2021-03-09,ACTUAL,2021-03-09,,INTERVENTIONAL,,Demographic and baseline characteristics were assessed in the Safety Analysis Set.,DS-3201b for Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL),A Phase 1 Study of DS-3201b in Subjects With Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL),TERMINATED,,PHASE1,28.0,ACTUAL,Daiichi Sankyo,,5.0,,This study was terminated due to slow accrual.,f,,,,t,t,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,INDUSTRY,,,,,,,2021,0.0
NCT03888092,,2019-03-18,,,2023-03-20,2019-03-21,2019-03-25,ACTUAL,,,,,,,2023-03-20,2023-03-21,ACTUAL,2017-08-18,ACTUAL,2017-08-18,2022-05,2022-05-31,2022-12-13,ACTUAL,2022-12-13,2022-12-13,ACTUAL,2022-12-13,,INTERVENTIONAL,,,Z650 in Advanced Esophageal Squamous Cell Carcinoma With EGFR Over Expression or Gene Amplification,"A Phase Ib, Multi-center, Open-label Study of Z650 in Advanced Esophageal Squamous Cell Carcinoma (ECSS) With Epidermal Growth Factor Receptor (EGFR) Over Expression or Gene Amplification",COMPLETED,,PHASE1/PHASE2,81.0,ACTUAL,"Sunshine Lake Pharma Co., Ltd.",,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,INDUSTRY,,,,,,,2022,1.0
NCT01836068,,2013-04-16,,,2021-11-22,2013-04-18,2013-04-19,ESTIMATED,,,,,,,2021-11-22,2021-11-23,ACTUAL,2013-06,ACTUAL,2013-06-30,2021-06,2021-06-30,2021-06-05,ACTUAL,2021-06-05,2020-01-22,ACTUAL,2020-01-22,,INTERVENTIONAL,,,Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals,Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1-infected Individuals,COMPLETED,,EARLY_PHASE1,11.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,OTHER,,,,,,,2021,1.0
NCT03655613,,2018-07-17,,,2022-05-03,2018-08-30,2018-08-31,ACTUAL,,,,,,,2022-05-03,2022-05-06,ACTUAL,2018-09-05,ACTUAL,2018-09-05,2022-05,2022-05-31,2021-12-15,ACTUAL,2021-12-15,2021-12-15,ACTUAL,2021-12-15,,INTERVENTIONAL,,,APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC,A Phase 1/2 Dose Escalation and Expansion Study of Combination APL-501 or Nivolumab With APL-101 in Locally Advanced or Metastatic Hepatocellular and Renal Cell Carcinoma,TERMINATED,,PHASE1/PHASE2,20.0,ACTUAL,Apollomics (Australia) Pty. Ltd.,,2.0,,Study terminated due to administrative reasons.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,INDUSTRY,,,,,,,2021,0.0
NCT03362424,,2017-11-29,,,2022-10-17,2017-12-04,2017-12-05,ACTUAL,,,,,,,2022-10-17,2022-10-19,ACTUAL,2020-11-01,ACTUAL,2020-11-01,2022-10,2022-10-31,2023-12-01,ESTIMATED,2023-12-01,2023-12-01,ESTIMATED,2023-12-01,,INTERVENTIONAL,,,Mesenchymal Stem Cells in Rotator Cuff Repair,Mesenchymal Stem Cells in Rotator Cuff Repair - a Randomized Prospective Study,SUSPENDED,,PHASE2,44.0,ESTIMATED,University of Sao Paulo,,2.0,,Cryogenesis company stopped supplying mesenchymal cells,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,OTHER,,,,,,,2023,0.0
NCT03704298,,2018-10-10,2023-12-11,,2024-06-26,2018-10-10,2018-10-12,ACTUAL,2024-06-26,2024-06-28,ACTUAL,,,,2024-06-26,2024-06-28,ACTUAL,2018-11-20,ACTUAL,2018-11-20,2024-06,2024-06-30,2022-12-15,ACTUAL,2022-12-15,2021-05-07,ACTUAL,2021-05-07,,INTERVENTIONAL,ZUMA-11,The Safety Analysis Set is defined as all participants treated with any dose of axicabtagene ciloleucel.,Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Refractory Large B-cell Lymphoma,A Phase 1/2 Multi-center Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Subjects With Relapsed/Refractory Large B-Cell Lymphoma,TERMINATED,,PHASE1,15.0,ACTUAL,Gilead Sciences,,6.0,,Development program terminated,f,,,,f,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gileadclinicaltrials.com/transparency-policy/,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/",2024-10-15 16:12:55.915477,2024-10-15 16:12:55.915477,INDUSTRY,,,,,,,2022,0.0
NCT04120402,,2019-10-07,2024-05-03,,2024-05-29,2019-10-07,2019-10-09,ACTUAL,2024-05-29,2024-06-25,ACTUAL,,,,2024-05-29,2024-06-25,ACTUAL,2021-09-10,ACTUAL,2021-09-10,2024-05,2024-05-31,2023-06-01,ACTUAL,2023-06-01,2023-05-17,ACTUAL,2023-05-17,,INTERVENTIONAL,SPRINGBOARD,"The intention-to-treat (ITT) population consisted of all subjects who were both randomized to and received treatment. Analysis was conducted allocating subjects to the treatment to which they were randomized, irrespective of what was actually received. The safety population consisted of all randomized subjects who were administered a dose of study drug. The subjects in this group were analyzed based on the treatment they received.",Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee,"A Phase 2, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety, Efficacy and Pharmacokinetics of Single Dose EP-104IAR for 24 Weeks in Patients With Osteoarthritis of the Knee",COMPLETED,,PHASE2,318.0,ACTUAL,Eupraxia Pharmaceuticals Inc.,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,INDUSTRY,,,,,,,2023,1.0
NCT04458298,,2020-06-29,,,2023-02-09,2020-07-02,2020-07-07,ACTUAL,,,,,,,2023-02-09,2023-02-13,ACTUAL,2020-08-11,ACTUAL,2020-08-11,2023-02,2023-02-28,2022-08-12,ACTUAL,2022-08-12,2022-08-12,ACTUAL,2022-08-12,,INTERVENTIONAL,PRANA,,A Study to Evaluate OP-101 (Dendrimer N-acetyl-cysteine) in Severe Coronavirus Disease 2019 (COVID-19) Patients,"A Two-Stage, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of OP-101 (Dendrimer N-acetyl-cysteine) in Patients With Severe COVID-19",TERMINATED,,PHASE2,28.0,ACTUAL,"Ashvattha Therapeutics, Inc.",,6.0,,Lack of enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,INDUSTRY,,,,,,,2022,0.0
NCT03159988,,2016-10-23,,,2021-07-23,2017-05-17,2017-05-19,ACTUAL,,,,,,,2021-07-23,2021-07-28,ACTUAL,2016-04,,2016-04-30,2021-07,2021-07-31,2022-11-15,ESTIMATED,2022-11-15,2022-11-15,ESTIMATED,2022-11-15,,INTERVENTIONAL,,,Angiotensin (1-7) Treatment to Improve Cognitive Functioning in Heart Failure Patients,Angiotensin (1-7) Treatment to Improve Cognitive Functioning in Heart Failure Patients,SUSPENDED,,PHASE2,6.0,ACTUAL,University of Arizona,,1.0,,Slow enrollment,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,OTHER,,,,,,,2022,0.0
NCT04572776,,2020-09-29,,,2021-11-02,2020-09-29,2020-10-01,ACTUAL,,,,,,,2021-11-02,2021-11-09,ACTUAL,2020-12,ESTIMATED,2020-12-31,2021-11,2021-11-30,2023-03,ESTIMATED,2023-03-31,2023-03,ESTIMATED,2023-03-31,,INTERVENTIONAL,,,Phase 3 Study to Assess Resiniferatoxin vs Standard of Care for the Treatment of Intractable Cancer Pain,"A Multicenter, Randomized, 2-Arm, Phase 3 Study to Assess the Efficacy and Safety of a Single Epidural Administration of Resiniferatoxin Versus Standard of Care (SoC) for the Treatment of Intractable Pain Associated With Cancer",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,2.0,,To be replaced by a different protocol,f,,,,t,t,f,,,f,,,,,,,,2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,INDUSTRY,,,,,,,2023,0.0
NCT03875495,,2019-03-13,2021-04-13,,2022-01-27,2019-03-13,2019-03-14,ACTUAL,2022-01-27,2022-01-28,ACTUAL,,,,2022-01-27,2022-01-28,ACTUAL,2019-03-06,ACTUAL,2019-03-06,2022-01,2022-01-31,2021-04-02,ACTUAL,2021-04-02,2021-04-02,ACTUAL,2021-04-02,,INTERVENTIONAL,,No patients completed the baseline visit,A Phase I/II Study Evaluating Temferon in Multiple Myeloma Patients With Early Relapse After Front Line Therapy (TEM-MM),A Phase I/II Dose Escalation Study Evaluating Safety and Activity of Autologous CD34+-Enriched Hematopoietic Progenitor Cells Genetically Modified With a Lentiviral Vector Encoding for the Human Interferon-ɑ2 Gene in Multiple Myeloma Patients With Early Relapse After Intensive Front Line Therapy,TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,Genenta Science,"Although 3 patients were recruited, no patients received Temferon",1.0,,Failure to recruit patients,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 16:12:55.915477,2024-10-15 16:12:55.915477,INDUSTRY,,,,,,,2021,0.0
NCT04602117,,2020-10-12,,,2023-11-14,2020-10-20,2020-10-26,ACTUAL,,,,,,,2023-11-14,2023-11-18,ACTUAL,2021-07-28,ACTUAL,2021-07-28,2023-11,2023-11-30,2021-11-17,ACTUAL,2021-11-17,2021-11-17,ACTUAL,2021-11-17,,INTERVENTIONAL,,,ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer,ISPY-P1.01: Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer: A Phase I/Ib Trial,WITHDRAWN,,PHASE1,0.0,ACTUAL,QuantumLeap Healthcare Collaborative,,1.0,,Study withdrawn as scientific interest in pursuing the SYD985+Paclitaxel combination has diminished.,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,OTHER,,,,,,,2021,0.0
NCT02607813,,2015-11-05,,,2022-12-20,2015-11-17,2015-11-18,ESTIMATED,,,,,,,2022-12-20,2022-12-21,ACTUAL,2016-01-18,ACTUAL,2016-01-18,2022-03,2022-03-31,2022-02-19,ACTUAL,2022-02-19,2022-02-18,ACTUAL,2022-02-18,,INTERVENTIONAL,,,Phase I Study of LXH254 in Patients With Advanced Solid Tumors Haboring MAPK Pathway Alterations,A Phase I Dose Finding Study of Oral LXH254 in Adult Patients With Advanced Solid Tumors Harboring MAPK Pathway Alterations,TERMINATED,,PHASE1,142.0,ACTUAL,Novartis,,6.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,INDUSTRY,,,,,,,2022,0.0
NCT03726879,,2018-10-30,2022-01-21,,2024-01-29,2018-10-30,2018-11-01,ACTUAL,2022-03-24,2022-03-25,ACTUAL,,,,2024-01-29,2024-01-31,ACTUAL,2019-01-11,ACTUAL,2019-01-11,2024-01,2024-01-31,2023-08-24,ACTUAL,2023-08-24,2021-02-05,ACTUAL,2021-02-05,,INTERVENTIONAL,IMpassion050,,A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer,"A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer",COMPLETED,,PHASE3,454.0,ACTUAL,Hoffmann-La Roche,"On February 5, 2021, the experimental treatment was discontinued and unblinded following the recommendation of the independent Data Monitoring Committee (iDMC) to stop treatment with atezolizumab/placebo.",2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 16:12:55.915477,2024-10-15 16:12:55.915477,INDUSTRY,,,,,,,2023,1.0
NCT04608812,,2020-10-21,,,2023-08-15,2020-10-28,2020-10-29,ACTUAL,,,,,,,2023-08-15,2023-08-18,ACTUAL,2021-03-02,ACTUAL,2021-03-02,2023-08,2023-08-31,2023-02-27,ACTUAL,2023-02-27,2023-02-27,ACTUAL,2023-02-27,,INTERVENTIONAL,,,Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection,A Pilot Study of Intratumorally and Intraparenchymally Administered OS2966 Using Convection-enhanced Delivery in Patients With Recurrent/Progressive High-grade Glioma Undergoing a Clinically-indicated Surgical Resection,TERMINATED,,PHASE1,7.0,ACTUAL,"OncoSynergy, Inc.",,1.0,,Slow enrollment and financial constraints.,,,,,f,t,f,,,,,,,,,,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,INDUSTRY,,,,,,,2023,0.0
NCT04058197,,2019-06-18,,,2021-11-21,2019-08-13,2019-08-15,ACTUAL,,,,,,,2021-11-21,2021-12-02,ACTUAL,2020-07-21,ACTUAL,2020-07-21,2020-11,2020-11-30,2021-10-06,ACTUAL,2021-10-06,2021-10-06,ACTUAL,2021-10-06,,INTERVENTIONAL,D-SCOUT,,Deferoxamine for Sickle Cell Chronic Leg Ulcer Treatment,"A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Efficacy of Deferoxamine Intradermal Delivery Patch (DIDP) in Chronic Sickle Cell Leg Ulcers",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,TauTona Group,,2.0,,Lack of enrollment,f,,,,f,t,f,,,,,,,,,,,2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,INDUSTRY,,,,,,,2021,0.0
NCT03851263,,2019-02-12,,,2019-12-04,2019-02-20,2019-02-22,ACTUAL,,,,,,,2019-12-04,2019-12-06,ACTUAL,2019-08-30,ESTIMATED,2019-08-30,2019-12,2019-12-31,2023-02-24,ESTIMATED,2023-02-24,2021-08-27,ESTIMATED,2021-08-27,,INTERVENTIONAL,MARKOV,,Multislice Computed Tomography Assessment of PCSK9 Inhibition on Coronary Perfusion,Multi-slice CT Scan Assessment of the Impact of PCSK9 Inhibition With Evolocumab on Coronary Perfusion in Patients With Reduced Coronary Fractional Flow Reserve (FFR).,WITHDRAWN,,PHASE4,0.0,ACTUAL,ECRI bv,,1.0,,Admisnitrative issues,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,INDUSTRY,,,,,,,2023,0.0
NCT03896945,,2019-03-19,,2024-05-21,2024-05-21,2019-03-28,2019-04-01,ACTUAL,,,,,2023-12-20,ACTUAL,2024-05-21,2024-05-24,ACTUAL,2019-02-15,ACTUAL,2019-02-15,2024-05,2024-05-31,2023-05-23,ACTUAL,2023-05-23,2023-05-23,ACTUAL,2023-05-23,,INTERVENTIONAL,,,"Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia","A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Negative Symptoms of Schizophrenia",TERMINATED,,PHASE2/PHASE3,136.0,ACTUAL,"Otsuka Pharmaceutical Development & Commercialization, Inc.",,2.0,,"Based on the Interim Analysis outcome and recommendation by the DMC, Otsuka approved termination of the study based on futility.",f,,,,,t,f,,,,,,"Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.",Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/,https://clinical-trials.otsuka.com,YES,Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,INDUSTRY,,,,,,,2023,0.0
NCT04424225,,2020-06-05,,,2024-05-31,2020-06-05,2020-06-09,ACTUAL,,,,,,,2024-05-31,2024-06-03,ACTUAL,2021-08-30,ACTUAL,2021-08-30,2024-05,2024-05-31,2023-09-01,ACTUAL,2023-09-01,2023-09-01,ACTUAL,2023-09-01,,INTERVENTIONAL,,,Visual Surround Suppression and Perceptual Expectation Under Psilocybin,Visual Surround Suppression and Perceptual Expectation Under Psilocybin,TERMINATED,,PHASE1,10.0,ACTUAL,University of Minnesota,,2.0,,Could not secure additional funding to continue the study. Pilot phase of study completed.,f,,,,t,t,f,,,,,,,,,YES,"For data releases, requests for sharing will be made to the PI, Jessica Nielson or the student investigator, Link Swanson, and/or co-investigators Michael-Paul Schallmo, Kathryn Cullen, or Ranji Varghese and granted on an individual basis",2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,OTHER,,,,,,,2023,0.0
NCT02781506,,2016-05-19,2022-04-29,,2022-07-12,2016-05-19,2016-05-24,ESTIMATED,2022-07-12,2022-08-08,ACTUAL,,,,2022-07-12,2022-08-08,ACTUAL,2016-06-20,ACTUAL,2016-06-20,2022-07,2022-07-31,2021-05-24,ACTUAL,2021-05-24,2021-05-24,ACTUAL,2021-05-24,,INTERVENTIONAL,,,Nivolumab and Stereotactic Ablative Radiation Therapy (SAbR) for Metastatic Clear Cell Renal Cell Carcinoma,Phase II Trial of Nivolumab and Stereotactic Ablative Radiation Therapy (SAbR) for Metastatic Clear Cell Renal Cell Carcinoma (mRCC),TERMINATED,,PHASE2,7.0,ACTUAL,University of Texas Southwestern Medical Center,,1.0,,"Since the treatment landscape for metastatic kidney cancer changed, patients were not becoming eligible for this trial and therefore, the trial was terminated.",f,,,,t,,,,,,,,,,,NO,,2024-10-15 16:12:55.915477,2024-10-15 16:12:55.915477,OTHER,,,,,,,2021,0.0
NCT04057573,,2019-08-14,2022-07-20,2022-03-08,2022-08-25,2019-08-14,2019-08-15,ACTUAL,2022-08-25,2022-09-21,ACTUAL,2022-08-25,2022-09-21,ACTUAL,2022-08-25,2022-09-21,ACTUAL,2019-10-03,ACTUAL,2019-10-03,2022-08,2022-08-31,2021-10-01,ACTUAL,2021-10-01,2021-03-15,ACTUAL,2021-03-15,,INTERVENTIONAL,,"Baseline data are reported for members of the Safety Population, comprised of all participants who applied ruxolitinib cream or vehicle cream at least once. Treatment groups for this population were determined according to the actual treatment the participant applied on Day 1.",Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2),"Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo",COMPLETED,,PHASE3,344.0,ACTUAL,Incyte Corporation,Data from participants at a single site were excluded from all efficacy analyses done on the Intent-to-Treat Population owing to serious noncompliance with the protocol resulting in serious concerns with the data quality.,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,INDUSTRY,,,,,,,2021,1.0
NCT02864368,,2016-07-26,2021-08-18,,2022-06-07,2016-08-10,2016-08-12,ESTIMATED,2021-10-12,2021-11-09,ACTUAL,,,,2022-06-07,2022-06-09,ACTUAL,2016-12-07,ACTUAL,2016-12-07,2022-06,2022-06-30,2020-06-15,ACTUAL,2020-06-15,2020-06-15,ACTUAL,2020-06-15,,INTERVENTIONAL,PERFORMANCE,,Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens,Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens,TERMINATED,,PHASE1,27.0,ACTUAL,Duke University,,5.0,,Funding,f,,,,t,,,,,,,,,,,,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,OTHER,,,,,,,2020,0.0
NCT04036968,,2019-07-25,2023-10-31,,2023-12-15,2019-07-25,2019-07-30,ACTUAL,2023-12-15,2023-12-19,ACTUAL,,,,2023-12-15,2023-12-19,ACTUAL,2020-02-01,ACTUAL,2020-02-01,2023-12,2023-12-31,2022-11-01,ACTUAL,2022-11-01,2022-11-01,ACTUAL,2022-11-01,,INTERVENTIONAL,,,Enhancing Medication-based Analgesia in Humans- STUDY 2,Evaluating Cannabidiol (CBD) to Enhance the Analgesic Effect of Hydromorphone in Humans,COMPLETED,,PHASE2,31.0,ACTUAL,Johns Hopkins University,,5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,OTHER,,,,,,,2022,1.0
NCT05133323,,2021-11-15,2024-01-15,,2024-03-12,2021-11-15,2021-11-24,ACTUAL,2024-01-15,2024-02-08,ACTUAL,,,,2024-03-12,2024-03-13,ACTUAL,2021-11-11,ACTUAL,2021-11-11,2024-03,2024-03-31,2023-03-16,ACTUAL,2023-03-16,2023-01-19,ACTUAL,2023-01-19,,INTERVENTIONAL,,The all-participants-treated set (APTS) represents all randomized participants who received an infusion of investigational medicinal product,A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments,"Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lu AG09222 for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments",COMPLETED,,PHASE2,237.0,ACTUAL,H. Lundbeck A/S,,3.0,,,,,,,t,t,f,,,,,,,,,,,2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,INDUSTRY,,,,,,,2023,1.0
NCT02451423,,2015-03-04,2024-03-27,,2024-05-29,2015-05-21,2015-05-22,ESTIMATED,2024-05-29,2024-05-31,ACTUAL,,,,2024-05-29,2024-05-31,ACTUAL,2016-03-29,ACTUAL,2016-03-29,2024-05,2024-05-31,2023-03-31,ACTUAL,2023-03-31,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,,,Neoadjuvant Atezolizumab in Localized Bladder Cancer,Phase II Study of Neoadjuvant Atezolizumab-based Immunotherapy for Patients With Urothelial Carcinoma (NEBULA),COMPLETED,,PHASE2,23.0,ACTUAL,"University of California, San Francisco",,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:12:55.915477,2024-10-15 16:12:55.915477,OTHER,,,,,,,2023,1.0
NCT03138083,,2017-04-26,,,2020-06-08,2017-04-30,2017-05-03,ACTUAL,,,,,,,2020-06-08,2020-06-11,ACTUAL,2017-08-08,ACTUAL,2017-08-08,2020-06,2020-06-30,2020-05-25,ACTUAL,2020-05-25,2020-05-25,ACTUAL,2020-05-25,,INTERVENTIONAL,,,OMO-1 in Solid Malignancies,"A Modular, Multi-arm, Multi-part, First Time in Patient Study to Evaluate the Safety and Tolerability of OMO-1, Alone and in Combination With Anti-cancer Treatments, in Patients With Locally Advanced, Unresectable or Metastatic Solid Malignancies",TERMINATED,,PHASE1/PHASE2,40.0,ACTUAL,Octimet Oncology N.V.,,6.0,,strategic reasons (not due to lack of efficacy or safety issues),f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:12:55.915477,2024-10-15 16:12:55.915477,INDUSTRY,,,,,,,2020,0.0
NCT02200614,,2014-07-22,2019-08-30,,2022-06-02,2014-07-23,2014-07-25,ESTIMATED,2019-10-09,2019-10-29,ACTUAL,,,,2022-06-02,2022-06-28,ACTUAL,2014-09-12,ACTUAL,2014-09-12,2022-06,2022-06-30,2021-06-14,ACTUAL,2021-06-14,2018-09-03,ACTUAL,2018-09-03,,INTERVENTIONAL,ARAMIS,,Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer,"A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer",COMPLETED,,PHASE3,1509.0,ACTUAL,Bayer,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,INDUSTRY,,,,,,,2021,1.0
NCT03318952,,2017-10-05,,,2022-10-29,2017-10-21,2017-10-24,ACTUAL,,,,,,,2022-10-29,2022-11-03,ACTUAL,2022-09,ESTIMATED,2022-09-30,2022-10,2022-10-31,2023-06,ESTIMATED,2023-06-30,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,Articaine vs Lidocaine for Pediatric Dental Procedures,Efficacy of Articaine vs. Lidocaine When Used for Local Infiltration in Pediatric Dental Procedures,WITHDRAWN,,PHASE4,0.0,ACTUAL,Boston University,,2.0,,The research did not start and the PI transitioned to another institution.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 16:12:55.915477,2024-10-15 16:12:55.915477,OTHER,,,,,,,2023,0.0
NCT03773055,,2018-12-10,,,2020-11-12,2018-12-10,2018-12-12,ACTUAL,,,,,,,2020-11-12,2020-11-16,ACTUAL,2019-04-03,ACTUAL,2019-04-03,2020-08,2020-08-31,2020-09-30,ACTUAL,2020-09-30,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,,,Phase II Clinical Trial of NPC-06 in Patients With Neuropathic Pain in Cancer,"A Multicenter, Double-blind, Randomized, Placebo-controlled Parallel Group Trial to Investigate the Proof of Concept of NPC-06 in Patients With Neuropathic Pain in Cancer",TERMINATED,,PHASE2,7.0,ACTUAL,Nobelpharma,,3.0,,Low recruitment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 16:12:55.915477,2024-10-15 16:12:55.915477,INDUSTRY,,,,,,,2020,0.0
NCT04917692,,2021-05-14,,,2023-03-21,2021-06-07,2021-06-08,ACTUAL,,,,,,,2023-03-21,2023-03-23,ACTUAL,2021-07,ESTIMATED,2021-07-31,2023-03,2023-03-31,2022-10,ESTIMATED,2022-10-31,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,Empagliflozin in Adolescent Diabetes,Empagliflozin in Adolescent Diabetes,WITHDRAWN,,PHASE4,0.0,ACTUAL,Ohio State University,,1.0,,Not funded,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 16:12:55.915477,2024-10-15 16:12:55.915477,OTHER,,,,,,,2022,0.0
NCT04327024,,2020-03-13,2023-04-26,,2023-06-12,2020-03-27,2020-03-30,ACTUAL,2023-06-12,2023-06-29,ACTUAL,,,,2023-06-12,2023-06-29,ACTUAL,2020-05-19,ACTUAL,2020-05-19,2023-06,2023-06-30,2022-04-29,ACTUAL,2022-04-29,2022-04-29,ACTUAL,2022-04-29,,INTERVENTIONAL,AMETHYST,The Full Analysis Set includes all subjects who have been randomized to study treatment.,Study of Verinurad in Heart Failure With Preserved Ejection Fraction,"A Phase 2, Multicentre, Double-Blind, Placebo and Active Control Efficacy and Safety Study to Evaluate Verinurad Combined With Allopurinol in Heart Failure With Preserved Ejection Fraction",COMPLETED,,PHASE2,159.0,ACTUAL,AstraZeneca,,3.0,,,,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared",2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,INDUSTRY,,,,,,,2022,1.0
NCT04324359,,2020-03-25,2023-09-28,2021-10-13,2023-10-18,2020-03-25,2020-03-27,ACTUAL,2023-09-28,2023-10-18,ACTUAL,2021-10-15,2021-10-19,ACTUAL,2023-10-18,2023-10-23,ACTUAL,2020-03-03,ACTUAL,2020-03-03,2023-09,2023-09-30,2020-11-20,ACTUAL,2020-11-20,2020-11-03,ACTUAL,2020-11-03,,INTERVENTIONAL,,Randomized participants who underwent routine uncomplicated cataract surgery.,"Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery Subjects","A Multicenter, Randomized, Double-Masked Study To Compare The Ocular Safety, Tolerability, And Efficacy Of A Topical 0.2% Ophthalmic Corticosteroid Solution (SURF-201) To Vehicle In Cataract Surgery Subjects",COMPLETED,,PHASE2,91.0,ACTUAL,"Surface Ophthalmics, Inc.",,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,INDUSTRY,,,,,,,2020,1.0
NCT04318704,,2020-03-20,,,2022-07-18,2020-03-20,2020-03-24,ACTUAL,,,,,,,2022-07-18,2022-07-19,ACTUAL,2020-07-29,ACTUAL,2020-07-29,2022-03,2022-03-31,2022-05-10,ACTUAL,2022-05-10,2022-05-10,ACTUAL,2022-05-10,,INTERVENTIONAL,,,"Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough","An Open Label Study of the Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough",COMPLETED,,PHASE2,20.0,ACTUAL,Algernon Pharmaceuticals,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,INDUSTRY,,,,,,,2022,1.0
NCT02449161,,2015-05-13,,,2022-05-16,2015-05-19,2015-05-20,ESTIMATED,,,,,,,2022-05-16,2022-05-23,ACTUAL,2015-08,ACTUAL,2015-08-31,2022-05,2022-05-31,2021-05,ACTUAL,2021-05-31,2021-05,ACTUAL,2021-05-31,,INTERVENTIONAL,MPA postAE,,The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates,The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates: a RCT,TERMINATED,,PHASE3,60.0,ACTUAL,Université de Sherbrooke,,2.0,,Missing fund to continue,f,,,,f,,,,,,,,,,,,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,OTHER,,,,,,,2021,0.0
NCT04523831,,2020-08-19,2020-09-30,,2020-10-07,2020-08-20,2020-08-24,ACTUAL,2020-10-07,2020-10-09,ACTUAL,,,,2020-10-07,2020-10-09,ACTUAL,2020-06-01,ACTUAL,2020-06-01,2020-10,2020-10-31,2020-09-10,ACTUAL,2020-09-10,2020-08-22,ACTUAL,2020-08-22,,INTERVENTIONAL,,We followed intention to treat analysis; SPSS (Statistical Package for Social Sciences) version 20 was used to analyze data. To compare mean of the two group chi square test was done.,Clinical Trial of Ivermectin Plus Doxycycline for the Treatment of Confirmed Covid-19 Infection,A Phase III Trial to Promote Recovery From Covid 19 With Combined Doxycycline and Ivermectin Along Standard Care,COMPLETED,,PHASE3,400.0,ACTUAL,Dhaka Medical College,"We followed up the patients by telephonic (video) interview, which has some inherent drawback for the study. we could not assess viral clearance directly. Only single dose regimen was used. Efficacy might higher if the different regimen would use.",2.0,,,f,,,,t,f,f,,,,,,September 2020 to December 2020,Person who are investigating covid-19 in various aspects,,YES,"Patients age, sex, Date of covid positive report, Symtoms,Date of covid negative report, post covid symptoms, time to recover.",2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,OTHER,,,,,,,2020,1.0
NCT03440814,,2018-02-13,2023-06-30,,2023-08-25,2018-02-19,2018-02-22,ACTUAL,2023-08-25,2023-09-21,ACTUAL,,,,2023-08-25,2023-09-21,ACTUAL,2018-05-09,ACTUAL,2018-05-09,2023-06,2023-06-30,2020-05-01,ACTUAL,2020-05-01,2020-05-01,ACTUAL,2020-05-01,,INTERVENTIONAL,,Safety population includes all randomized subjects who receive any amount of study drug.,A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome,"A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome",COMPLETED,,PHASE3,127.0,ACTUAL,"Soleno Therapeutics, Inc.","All subjects were enrolled and had baseline visits prior to the COVID-19 pandemic; however, there was a subset of subjects who needed to complete some of their visits after the onset of the pandemic. The pandemic forced numerous restrictions on normal activities and involved significant disruptions, which had a substantially adverse but inconsistent effect on the study conduct and results. For this reason, the ITT population - Pre-COVID analysis includes all data through March 1, 2020.",2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,INDUSTRY,,,,,,,2020,1.0
NCT02258451,,2014-09-30,2022-01-17,,2023-11-22,2014-10-06,2014-10-07,ESTIMATED,2022-03-09,2022-03-10,ACTUAL,,,,2023-11-22,2023-11-24,ACTUAL,2015-06-04,ACTUAL,2015-06-04,2023-11,2023-11-30,2022-10-28,ACTUAL,2022-10-28,2020-01-22,ACTUAL,2020-01-22,,INTERVENTIONAL,,Intent-to-Treat Analysis Set (ITT analysis set): included all randomized participants,Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer,"A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases",COMPLETED,,PHASE2,283.0,ACTUAL,Bayer,"Due to reassessment of the Primary Completion date (PCD) conditions, PCD was moved back to 22 January 2020. Interim survival data on patients transferring from this study to study 16996 (NCT02312960), as of analysis cutoff, was pooled with this study's data to increase the reliability of efficacy results. This pooling was specified in a supplemental SAP dated 24 Jun 2020. All other primary and secondary analysis details were specified in the main study SAP dated 14 Feb 2020.",2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,INDUSTRY,,,,,,,2022,1.0
NCT04614298,,2020-10-27,,,2021-09-24,2020-11-01,2020-11-03,ACTUAL,,,,,,,2021-09-24,2021-09-30,ACTUAL,2021-01,ESTIMATED,2021-01-31,2021-09,2021-09-30,2022-11,ESTIMATED,2022-11-30,2022-02,ESTIMATED,2022-02-28,,INTERVENTIONAL,,,A Phase 4 Study of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis,A Phase 4 Clinical Study to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis,WITHDRAWN,,PHASE4,0.0,ACTUAL,"Kyowa Kirin Co., Ltd.",,2.0,,"Due to the reconsideration of KHK4827's business in China, it. was decided to withdraw this clinical trial prior to enrollment of first participant.",f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-17 01:13:00.736614,2024-10-17 01:13:00.736614,INDUSTRY,,,,,,,2022,0.0
NCT03262701,,2017-08-22,2022-05-10,,2022-11-29,2017-08-24,2017-08-25,ACTUAL,2022-11-29,2022-12-21,ACTUAL,,,,2022-11-29,2022-12-21,ACTUAL,2018-04-02,ACTUAL,2018-04-02,2022-11,2022-11-30,2021-02-08,ACTUAL,2021-02-08,2021-02-08,ACTUAL,2021-02-08,,INTERVENTIONAL,AHP,,Adjunctive Hydrogen Peroxide for Periodontal Therapy,Custom Tray Application of Peroxide Gel as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis: A 6-Month Randomized Trial,TERMINATED,,PHASE4,42.0,ACTUAL,Loma Linda University,"Due to COVID lockdown, the enrollment and study discontinued abruptly.",3.0,,COVID,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 16:12:55.915477,2024-10-15 16:12:55.915477,OTHER,,,,,,,2021,0.0
NCT02546492,,2015-04-10,2022-07-12,,2022-10-03,2015-09-10,2015-09-11,ESTIMATED,2022-10-03,2022-10-06,ACTUAL,,,,2022-10-03,2022-10-06,ACTUAL,2016-08,ACTUAL,2016-08-31,2022-10,2022-10-31,2021-05-27,ACTUAL,2021-05-27,2021-05-27,ACTUAL,2021-05-27,,INTERVENTIONAL,TGActhar,,Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar,Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar,TERMINATED,,PHASE4,6.0,ACTUAL,"University of Maryland, Baltimore","Only one participant completed the treatment with the study drug Acthar (24 weeks). The other five (5) individuals withdrew from the study early, therefore we are not able to analyze/interpret the efficacy of the study drug.",1.0,,Slow Enrollment,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,OTHER,,,,,,,2021,0.0
NCT02517697,,2015-08-05,,,2021-04-13,2015-08-05,2015-08-07,ESTIMATED,,,,,,,2021-04-13,2021-04-19,ACTUAL,2020-10,ESTIMATED,2020-10-31,2021-04,2021-04-30,2021-04-13,ACTUAL,2021-04-13,2021-04-13,ACTUAL,2021-04-13,,INTERVENTIONAL,ONPC,,Oral Nitrite Trial for Hypertension and Metabolic Syndrome,"Nitrite Modulation of Hypertension, Platelet Activation, and Endothelial and Mitochondrial Function",WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Pittsburgh,,2.0,,We will not initiate recruitment for this protocol due to lack of funding to support this placebo-controlled trial.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,OTHER,,,,,,,2021,0.0
NCT03154996,,2017-05-14,,,2022-06-30,2017-05-14,2017-05-16,ACTUAL,,,,,,,2022-06-30,2022-07-05,ACTUAL,2018-01-18,ACTUAL,2018-01-18,2022-06,2022-06-30,2021-08-20,ACTUAL,2021-08-20,2021-08-20,ACTUAL,2021-08-20,,INTERVENTIONAL,,,Chronic Convection Enhanced Delivery of Topotecan,Chronic Convection Enhanced Delivery of Topotecan for Recurrent High Grade Gliomas,COMPLETED,,PHASE1,5.0,ACTUAL,Columbia University,,1.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,OTHER,,,,,,,2021,1.0
NCT03656627,,2018-08-31,,,2023-02-14,2018-08-31,2018-09-04,ACTUAL,,,,,,,2023-02-14,2023-02-15,ACTUAL,2019-06-27,ACTUAL,2019-06-27,2023-02,2023-02-28,2021-03-18,ACTUAL,2021-03-18,2021-03-18,ACTUAL,2021-03-18,,INTERVENTIONAL,,,Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease,"Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease",TERMINATED,,PHASE1,7.0,ACTUAL,"Alliance Foundation Trials, LLC.",,2.0,,low accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,OTHER,,,,,,,2021,0.0
NCT03332836,,2017-10-26,,,2021-03-30,2017-11-01,2017-11-06,ACTUAL,,,,,,,2021-03-30,2021-04-01,ACTUAL,2017-10-25,ACTUAL,2017-10-25,2021-03,2021-03-31,2020-09-30,ACTUAL,2020-09-30,2019-01-30,ACTUAL,2019-01-30,,INTERVENTIONAL,,,Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus,"A Phase 1, Multiple Ascending Dose, Glucose Clamp Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM12460A Compared to Insulin Glargine in Subjects With Type 2 Diabetes Mellitus",TERMINATED,,PHASE1,21.0,ACTUAL,Hanmi Pharmaceutical Company Limited,,3.0,,Sopnsor decision,,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,INDUSTRY,,,,,,,2020,0.0
NCT05604742,,2022-10-30,,,2023-01-16,2022-10-30,2022-11-03,ACTUAL,,,,,,,2023-01-16,2023-01-18,ACTUAL,2022-01-01,ACTUAL,2022-01-01,2023-01,2023-01-31,2024-12-31,ESTIMATED,2024-12-31,2024-12-30,ESTIMATED,2024-12-30,,INTERVENTIONAL,,,Belimumab for Treatment of cGVHD Following Allo-HCT,Belimumab for Treatment of Chronic Graft-versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Nanfang Hospital, Southern Medical University",,3.0,,No patients eligible for inclusion,f,,,,,f,f,,,f,,,,,,NO,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,OTHER,,,,,,,2024,0.0
NCT03464019,,2018-03-07,2024-02-16,2024-01-18,2024-06-18,2018-03-07,2018-03-13,ACTUAL,2024-06-18,2024-07-12,ACTUAL,,2024-07-12,ACTUAL,2024-06-18,2024-07-12,ACTUAL,2018-06-18,ACTUAL,2018-06-18,2024-05,2024-05-31,2023-01-20,ACTUAL,2023-01-20,2023-01-20,ACTUAL,2023-01-20,,INTERVENTIONAL,NODE-301,Data presented for the overall safety population including participants that received at least one dose of study drug.,Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia (PSVT).,"Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia. NODE 301 and RAPID Studies",TERMINATED,,PHASE3,1097.0,ACTUAL,Milestone Pharmaceuticals Inc.,,6.0,,The closure of the event-driven study was terminated due to the total sample size was reached.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,OTHER,,,,,,,2023,0.0
NCT02793765,,2016-06-02,,,2017-10-26,2016-06-02,2016-06-08,ESTIMATED,,,,,,,2017-10-26,2017-10-30,ACTUAL,2016-12,,2016-12-31,2017-10,2017-10-31,2021-07,ESTIMATED,2021-07-31,2018-07,ESTIMATED,2018-07-31,,INTERVENTIONAL,,,Docetaxel Followed by Provenge in Metastatic Prostate Cancer,Docetaxel Followed by Provenge in Castration-Resistant Prostate Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,"The University of Texas Health Science Center, Houston",,1.0,,Dendreon was sold and new company decided not to fund study.,f,,,,t,,,,,,,,,,,NO,,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,OTHER,,,,,,,2021,0.0
NCT03225287,,2017-07-17,2022-09-07,,2023-09-20,2017-07-20,2017-07-21,ACTUAL,2022-10-26,2022-10-27,ACTUAL,,,,2023-09-20,2023-09-28,ACTUAL,2017-07-17,ACTUAL,2017-07-17,2023-09,2023-09-30,2021-10-26,ACTUAL,2021-10-26,2021-09-07,ACTUAL,2021-09-07,,INTERVENTIONAL,,Baseline Characteristics refer to the Safety Population which consisted of all participants who received at least 1 injection of zilucoplan on or after Day 1 of the extension study.,Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical Study,"A Multicenter, Open-label, Uncontrolled, Extension Study of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Have Completed a RA101495 Clinical Study",TERMINATED,,PHASE2,19.0,ACTUAL,UCB Pharma,,1.0,,"After careful consideration, UCB has decided to no longer pursue PNH as a potential indication for zilucoplan.",f,,,,,t,f,,,,,,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",http://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,INDUSTRY,,,,,,,2021,0.0
NCT05700734,,2023-01-17,,,2023-03-23,2023-01-17,2023-01-26,ACTUAL,,,,,,,2023-03-23,2023-03-27,ACTUAL,2023-04-17,ESTIMATED,2023-04-17,2023-03,2023-03-31,2024-02-14,ESTIMATED,2024-02-14,2024-02-14,ESTIMATED,2024-02-14,,INTERVENTIONAL,,,MK-8510 Monotherapy for the Treatment of Anti-retroviral naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8510-002),"A Single-dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-retroviral Activity of MK-8510 Monotherapy in Anti-retroviral-naïve HIV-1 Infected Participants",WITHDRAWN,,PHASE1,0.0,ACTUAL,Merck Sharp & Dohme LLC,,4.0,,Business Reasons,f,,,,f,t,f,,,t,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,INDUSTRY,,,,,,,2024,0.0
NCT03791918,,2019-01-01,,,2019-04-30,2019-01-01,2019-01-03,ACTUAL,,,,,,,2019-04-30,2019-05-02,ACTUAL,2019-01-01,ACTUAL,2019-01-01,2019-01,2019-01-31,2022-01-01,ESTIMATED,2022-01-01,2022-01-01,ESTIMATED,2022-01-01,,INTERVENTIONAL,,,Lenvatinib Plus PD-1 Antibody vs TACE for Intermediate-stage HCC Beyond Up-to-seven Criteria,Lenvatinib Plus Programmed Cell Death Protein-1 (PD-1) Antibody Versus Transarterial Chemoembolization for Intermediate-stage Hepatocellular Carcinoma Beyond Up-to-seven Criteria,WITHDRAWN,,PHASE3,0.0,ACTUAL,Sun Yat-sen University,,2.0,,No participants enrolled,f,,,,t,f,f,,,,,,,,,,,2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,OTHER,,,,,,,2022,0.0
NCT01868880,,2013-05-09,,,2020-03-11,2013-06-04,2013-06-05,ESTIMATED,,,,,,,2020-03-11,2020-03-13,ACTUAL,2016-02,,2016-02-29,2020-03,2020-03-31,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Effect of Ivabradine and Beta-blockers Combination Versus Beta-blockers Up-titration on Right Ventricular Pacing,Effect of Heart Rate Control Using Ivabradine and Beta-blockers Combination Versus Beta-blockers Up-titration on Ventricular Pacing in Heart Failure Patients With an Implanted Cardioverter Defibrillator.,WITHDRAWN,,PHASE4,0.0,ACTUAL,Policlinico Casilino ASL RMB,,2.0,,difficulties in recruiting patients,f,,,,f,,,,,,,,,,,,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,OTHER,,,,,,,2023,0.0
NCT04990440,,2021-07-27,2023-03-08,,2023-04-28,2021-07-27,2021-08-04,ACTUAL,2023-04-28,2023-05-24,ACTUAL,,,,2023-04-28,2023-05-24,ACTUAL,2021-09-02,ACTUAL,2021-09-02,2023-04,2023-04-30,2022-03-09,ACTUAL,2022-03-09,2022-03-09,ACTUAL,2022-03-09,,INTERVENTIONAL,,,A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis,"A Phase 2a, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Interventional Study to Assess the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Multiple IV Doses of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis",TERMINATED,,PHASE2,6.0,ACTUAL,"Janssen Research & Development, LLC","The study 77474462ADM2001 (NCT04791319) was terminated due to futility analysis and no dose-response was observed. Based on study 77474462ADM2001 result, the current study (77474462ADM2003) was terminated early and thereby the planned Part C was not performed. Due to premature study termination, data collected up to Week 6 were analyzed and reported.",3.0,,Premature study termination (efficacy),f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,INDUSTRY,,,,,,,2022,0.0
NCT03608020,,2018-06-14,,,2024-04-17,2018-07-24,2018-07-31,ACTUAL,,,,,,,2024-04-17,2024-04-18,ACTUAL,2018-10-04,ACTUAL,2018-10-04,2024-04,2024-04-30,2024-04-15,ACTUAL,2024-04-15,2023-12-31,ACTUAL,2023-12-31,,INTERVENTIONAL,,,A Trial for Treatment of Cancer Patients With Multiple Brain Metastases Undergoing Whole-Brain Radiotherapy,A Safety Lead-In/Randomized Phase 2 Study of BMX-001 as a Therapeutic Agent for Treatment of Cancer Patients With Multiple Brain Metastases Undergoing Whole-Brain Radiotherapy,TERMINATED,,PHASE1/PHASE2,35.0,ACTUAL,"BioMimetix JV, LLC",,2.0,,Cessation of grant funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,INDUSTRY,,,,,,,2024,0.0
NCT03688074,,2018-09-26,2021-11-12,,2022-02-18,2018-09-26,2018-09-28,ACTUAL,2022-02-18,2022-02-21,ACTUAL,,,,2022-02-18,2022-02-21,ACTUAL,2018-11-02,ACTUAL,2018-11-02,2022-02,2022-02-28,2020-11-16,ACTUAL,2020-11-16,2020-11-16,ACTUAL,2020-11-16,,INTERVENTIONAL,CASCADE,"Full Analysis Set - Include all subjects randomised to study treatment who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.",Study to Evaluate Tezepelumab on Airway Inflammation in Adults With Uncontrolled Asthma (CASCADE),"A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Tezepelumab on Airway Inflammation in Adults With Inadequately Controlled Asthma on Inhaled Corticosteroids and at Least One Additional Asthma Controller (CASCADE)",COMPLETED,,PHASE2,116.0,ACTUAL,AstraZeneca,,2.0,,,,,,,,t,f,,,t,,,,,,,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,INDUSTRY,,,,,,,2020,1.0
NCT03699124,,2018-10-05,2021-03-05,,2021-05-05,2018-10-05,2018-10-09,ACTUAL,2021-05-05,2021-05-27,ACTUAL,,,,2021-05-05,2021-05-27,ACTUAL,2019-06-19,ACTUAL,2019-06-19,2020-07,2020-07-31,2020-06-22,ACTUAL,2020-06-22,2020-01-06,ACTUAL,2020-01-06,,INTERVENTIONAL,,"The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.",Freeze-Dried MVA-BN® Lot Consistency Smallpox Trial,"A Randomized, Double-blind, Multicenter Phase III Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of a Freeze-dried Formulation of MVA-BN® Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects",COMPLETED,,PHASE3,1129.0,ACTUAL,Bavarian Nordic,There were no limitations on the trial.,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,INDUSTRY,,,,,,,2020,1.0
NCT04990466,,2021-08-03,,,2024-01-17,2021-08-03,2021-08-04,ACTUAL,,,,,,,2024-01-17,2024-01-19,ACTUAL,2021-09-30,ESTIMATED,2021-09-30,2024-01,2024-01-31,2022-02-28,ESTIMATED,2022-02-28,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,BRILIFE002,,Phase 2b/3 Trial of VSV-ΔG SARS-CoV-2 Vaccine (BRILIFE) Against Approved Comparator Vaccine.,"A Phase IIb/3 Randomized, Multi-Center, Placebo-Controlled Noninferiority Study to Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine (IIBR-100) in Adults Compared to an Approved COVID-19 Vaccine",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,"NeuroRx, Inc.",,2.0,,Production of the BriLife vaccine was halted by government sponsor,f,,,,t,f,f,,,,,,"Protocol, SAP, and ICF will be shared prior to first patient visit. CSR will be shared following regulatory determination",all qualified researchers,,YES,"Vaccination dates, baseline serology, and post-vaccination serology/cellular immunity/infection rates will be shared",2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,INDUSTRY,,,,,,,2022,0.0
NCT04668144,,2020-12-09,2024-02-02,,2024-03-18,2020-12-09,2020-12-16,ACTUAL,2024-03-18,2024-03-20,ACTUAL,,,,2024-03-18,2024-03-20,ACTUAL,2021-02-18,ACTUAL,2021-02-18,2024-03,2024-03-31,2023-05-11,ACTUAL,2023-05-11,2023-02-02,ACTUAL,2023-02-02,,INTERVENTIONAL,SWAP-6,Patients who were randomized and received study medications,Pharmacodynamic and Pharmacokinetic of Switching From Cangrelor to Prasugrel in ACS Patients Undergoing PCI,Pharmacodynamic and Pharmacokinetic Profiles on Switching From Cangrelor to Prasugrel in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: The Switching Antiplatelet -6 (SWAP-6) Study,COMPLETED,,PHASE4,359.0,ACTUAL,University of Florida,,3.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,OTHER,,,,,,,2023,1.0
NCT04413253,,2020-05-28,,,2022-04-11,2020-05-28,2020-06-02,ACTUAL,,,,,,,2022-04-11,2022-04-18,ACTUAL,2020-08-01,ACTUAL,2020-08-01,2022-04,2022-04-30,2022-04-11,ACTUAL,2022-04-11,2022-04-11,ACTUAL,2022-04-11,,INTERVENTIONAL,,,Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease,Intracanalicular Dexamethasone Used in Conjunction With Xiidra (Lifitegrast Ophthalmic Solution) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Xiidra Alone,TERMINATED,,PHASE4,5.0,ACTUAL,Eye Surgeons of Indiana,,2.0,,Unable to recruit,,,,,f,t,f,,,,,,,,,,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,NETWORK,,,,,,,2022,0.0
NCT04531748,,2020-08-27,,,2021-05-05,2020-08-27,2020-08-28,ACTUAL,,,,,,,2021-05-05,2021-05-10,ACTUAL,2021-12,ESTIMATED,2021-12-31,2021-05,2021-05-31,2022-09,ESTIMATED,2022-09-30,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,SENTINEL,,Selective Estrogen Modulation and Melatonin in Early COVID-19,Selective Estrogen Modulation and Melatonin in Early COVID-19,WITHDRAWN,,PHASE2,0.0,ACTUAL,The Cleveland Clinic,,3.0,,Funding,f,,,,t,t,f,,,,,,,,,,,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,OTHER,,,,,,,2022,0.0
NCT05168865,,2021-12-10,,,2024-02-19,2021-12-10,2021-12-23,ACTUAL,,,,,,,2024-02-19,2024-02-20,ACTUAL,2023-08-01,ESTIMATED,2023-08-01,2024-02,2024-02-29,2024-04-01,ESTIMATED,2024-04-01,2024-02-01,ESTIMATED,2024-02-01,,INTERVENTIONAL,,,Letrozole Versus Hormonal Preparation in Frozen Cycles of PCOS Patients.,Letrozole Versus Hormonal Preparation in Frozen Cycles of PCOS Patients. Randomized Controlled Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,Dubai Fertility Center,,2.0,,unexpected slow recruitment and change of center frozen embryo transfer protocol,f,,,,,f,f,,,,,,,,,,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,OTHER,,,,,,,2024,0.0
NCT03524820,,2018-03-07,,,2022-08-02,2018-05-13,2018-05-15,ACTUAL,,,,,,,2022-08-02,2022-08-04,ACTUAL,2017-10-17,ACTUAL,2017-10-17,2021-02,2021-02-28,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Cetuximab Therapy for Third Line Rechallenge in Metastatic Colorectal Cancer,"Cetuximab Monotherapy or Cetuximab + Chemotherapy for Third Line Rechallenge in Metastatic Colorectal Cancer, RAS+ (RAt Sarcoma Gene) Wild Type Patients, Who Were Treated With Cetuximab Chemotherapy as First Line Treatment",TERMINATED,,PHASE2,3.0,ACTUAL,Hadassah Medical Organization,,1.0,,By Merck,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,OTHER,,,,,,,2021,0.0
NCT05639192,,2022-12-03,,,2023-08-28,2022-12-03,2022-12-06,ACTUAL,,,,,,,2023-08-28,2023-08-29,ACTUAL,2022-11-03,ACTUAL,2022-11-03,2022-11,2022-11-30,2023-08-18,ACTUAL,2023-08-18,2023-08-18,ACTUAL,2023-08-18,,INTERVENTIONAL,ASUCOV,,Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease,"A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy of Asunercept for the Treatment of Hospitalized Patients With Moderate to Severe COVID 19 Disease",TERMINATED,,PHASE3,34.0,ACTUAL,Apogenix AG,,2.0,,Lack of patients,f,,,,t,f,f,,,,,,,,,,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,INDUSTRY,,,,,,,2023,0.0
NCT04680936,,2020-12-13,,,2022-05-21,2020-12-22,2020-12-23,ACTUAL,,,,,,,2022-05-21,2022-05-26,ACTUAL,2021-01-01,ACTUAL,2021-01-01,2022-05,2022-05-31,2022-05-21,ACTUAL,2022-05-21,2022-05-01,ACTUAL,2022-05-01,,INTERVENTIONAL,,,Low and High Dose Dextrose Prolotherapy in the Treatment of Lateral Epicondylitis,Is Low Dose Dextrose Prolotherapy as Effective as High Dose Dextrose Prolotherapy in the Treatment of Lateral Epicondylitis?- A Double Blind- Ultrasound Guided- Randomized Controlled Study,COMPLETED,,PHASE4,75.0,ACTUAL,Ahi Evran University Education and Research Hospital,,3.0,,,f,,,,,f,f,,,f,,,,,,NO,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,OTHER,,,,,,,2022,1.0
NCT03506048,,2018-04-13,2022-07-13,,2022-10-18,2018-04-20,2018-04-23,ACTUAL,2022-10-18,2022-11-10,ACTUAL,,,,2022-10-18,2022-11-10,ACTUAL,2019-01-16,ACTUAL,2019-01-16,2022-10,2022-10-31,2021-06-24,ACTUAL,2021-06-24,2021-06-24,ACTUAL,2021-06-24,,INTERVENTIONAL,,,Lenvatinib and Iodine Therapy in Treating Patients With Radioactive Iodine-Sensitive Differentiated Thyroid Cancer,A Phase 2 Study of Lenvatinib in Combination With Radioactive Iodine Therapy in Patients With Progressive RAI-Sensitive Differentiated Thyroid Cancer,TERMINATED,,PHASE2,4.0,ACTUAL,Emory University,Early termination of the study because of recruitment difficulties lead to insufficient data collection and analysis of primary and secondary outcome measures. Pharmaceutical company terminated study.,1.0,,Study has been abandoned for lack of accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,OTHER,,,,,,,2021,0.0
NCT04149444,,2019-10-23,,,2020-06-09,2019-10-31,2019-11-04,ACTUAL,,,,,,,2020-06-09,2020-06-11,ACTUAL,2020-02,ESTIMATED,2020-02-29,2019-10,2019-10-31,2020-06-09,ACTUAL,2020-06-09,2020-06-09,ACTUAL,2020-06-09,,INTERVENTIONAL,TACTIC,,A Study of Trifluridine/Tipiracil in Triple Negative Metastatic Breast Cancer,A Phase 2 Study of Trifluridine/Tipiracil in Triple Negative Metastatic Breast Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,AHS Cancer Control Alberta,,1.0,,Sponsor withdrew support,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,OTHER,,,,,,,2020,0.0
NCT04343755,,2020-04-08,2023-06-22,,2023-09-15,2020-04-09,2020-04-13,ACTUAL,2023-09-15,2023-09-18,ACTUAL,,,,2023-09-15,2023-09-18,ACTUAL,2020-04-09,ACTUAL,2020-04-09,2023-09,2023-09-30,2023-04-26,ACTUAL,2023-04-26,2023-04-26,ACTUAL,2023-04-26,,INTERVENTIONAL,,,Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection,Phase IIa Study Exploring the Safety and Efficacy of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Hospitalized Subjects With COVID-19 Infection,TERMINATED,,PHASE2,52.0,ACTUAL,Hackensack Meridian Health,,1.0,,Lack of eligible patients due to change in standard therapy,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,OTHER,,,,,,,2023,0.0
NCT03338764,,2017-11-03,,,2024-04-15,2017-11-08,2017-11-09,ACTUAL,,,,,,,2024-04-15,2024-04-17,ACTUAL,2023-05,ESTIMATED,2023-05-31,2024-04,2024-04-30,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,An Investigational Study to Assess Efficacy and Pattern of Use of SM-1 in Subjects With a History of Transient Insomnia,"A Double-Blind, Placebo-Controlled, Parallel Design Phase 3 Study to Assess the Efficacy, Safety, Tolerability, and Pattern of Use of SM-1 in Adult Subjects With a History of Transient Insomnia",WITHDRAWN,,PHASE3,0.0,ACTUAL,Sequential Medicine Ltd,,2.0,,no participants enrolled,f,,,,f,t,f,,,,,,,,,,,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,INDUSTRY,,,,,,,2023,0.0
NCT02748564,,2016-04-19,2022-07-25,,2023-08-02,2016-04-21,2016-04-22,ESTIMATED,2023-02-08,2023-02-09,ACTUAL,,,,2023-08-02,2023-08-03,ACTUAL,2017-03-21,ACTUAL,2017-03-21,2023-08,2023-08-31,2023-06-05,ACTUAL,2023-06-05,2018-10-18,ACTUAL,2018-10-18,,INTERVENTIONAL,,,Aldesleukin and Pembrolizumab in Treating Patients With Stage III-IV Melanoma,Trial of Interleukin-2 in Combination With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma,TERMINATED,,PHASE2,10.0,ACTUAL,"Rutgers, The State University of New Jersey",,1.0,,Study Complete,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,OTHER,,,,,,,2023,0.0
NCT04358471,,2020-03-22,,,2021-05-06,2020-04-20,2020-04-24,ACTUAL,,,,,,,2021-05-06,2021-05-10,ACTUAL,2021-07-31,ESTIMATED,2021-07-31,2021-05,2021-05-31,2023-09-01,ESTIMATED,2023-09-01,2023-07-01,ESTIMATED,2023-07-01,,INTERVENTIONAL,,,Intravitreal AAVCAGsCD59 for Advanced Dry Age-related Macular Degeneration (AMD) With Geographic Atrophy (GA),A Phase 2 Multi-Center Trial Evaluating Intravitreal AAVCAGsCD59 Compared to Sham Injection for the Treatment of Advanced Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA),WITHDRAWN,,PHASE2,0.0,ACTUAL,Hemera Biosciences,,3.0,,The AAVCAGsCD59 asset has been transferred to Janssen Research and Development LLC,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,INDUSTRY,,,,,,,2023,0.0
NCT04994561,,2021-07-23,,,2022-06-02,2021-08-02,2021-08-06,ACTUAL,,,,,,,2022-06-02,2022-06-07,ACTUAL,2022-06,ESTIMATED,2022-06-30,2022-06,2022-06-30,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,"VIAging Deceleration Trial Using Metformin, Dasatinib, Rapamycin and Nutritional Supplements","Pilot Study to Test the Safety and Efficacy of Metformin, Dasatinib, Rapamycin and Nutritional Supplements (Bio-quercetin; Bio-fisetin; Glucosamine; Nicotinamide Riboside; Trans-resveratrol) in Reducing Clinical Measures of Aging in Older Adults",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Vitality in Aging Research Group, Inc.",,1.0,,Study was withdrawn,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,OTHER,,,,,,,2023,0.0
NCT02185417,,2014-06-30,2023-10-10,,2024-05-21,2014-07-03,2014-07-09,ESTIMATED,2024-05-21,2024-05-22,ACTUAL,,,,2024-05-21,2024-05-22,ACTUAL,2016-06-15,ACTUAL,2016-06-15,2024-05,2024-05-31,2022-12-29,ACTUAL,2022-12-29,2022-10-15,ACTUAL,2022-10-15,,INTERVENTIONAL,DCP,Analysis and report of baseline information according to the intention-to-treat principle. Baseline characteristics were not collected for providers.,Diuretic Comparison Project,CSP #597 - Diuretic Comparison Project,COMPLETED,,PHASE3,20723.0,ACTUAL,VA Office of Research and Development,"This trial had several important limitations:~* most patients treated with hydrochlorothiazide, including the VA population, received 12.5 to 25 mg, and only 5% in this trial had been receiving 50 mg of hydrochlorothiazide at baseline.~* only a subset of follow-up data from Medicare and NDI were available at the time of reporting.",3.0,,,f,,,,t,t,f,,,f,,,,,,NO,There is no IPD sharing plan description,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,FED,,,,,,,2022,1.0
NCT04214860,,2019-12-12,,,2022-01-18,2019-12-30,2020-01-02,ACTUAL,,,,,,,2022-01-18,2022-01-19,ACTUAL,2019-12-13,ACTUAL,2019-12-13,2022-01,2022-01-31,2022-01-14,ACTUAL,2022-01-14,2022-01-14,ACTUAL,2022-01-14,,INTERVENTIONAL,,,APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies,Phase I Study of APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies,COMPLETED,,PHASE1,51.0,ACTUAL,Aprea Therapeutics,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,INDUSTRY,,,,,,,2022,1.0
NCT05493293,,2022-08-05,,,2024-04-10,2022-08-05,2022-08-09,ACTUAL,,,,,,,2024-04-10,2024-04-12,ACTUAL,2022-11-09,ACTUAL,2022-11-09,2024-04,2024-04-30,2024-03-11,ACTUAL,2024-03-11,2024-03-11,ACTUAL,2024-03-11,,INTERVENTIONAL,,,Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures,"Prospective, Long-Term, Interventional, Active Extension Study to Evaluate the Safety and Tolerability of NBI-921352 as Adjunctive Therapy in Subjects With Focal Onset Seizures (FOS)",TERMINATED,,PHASE2,82.0,ACTUAL,Neurocrine Biosciences,,1.0,,The long-term extension study was terminated because the parent study NBI-921352-FOS2021 (NCT05159908) failed to meet its primary endpoint.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,INDUSTRY,,,,,,,2024,0.0
NCT04624113,,2020-11-09,,,2024-02-19,2020-11-09,2020-11-10,ACTUAL,,,,,,,2024-02-19,2024-02-21,ACTUAL,2021-04-14,ACTUAL,2021-04-14,2024-02,2024-02-29,2024-02-17,ACTUAL,2024-02-17,2022-08-09,ACTUAL,2022-08-09,,INTERVENTIONAL,,,"Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma","Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma: A Phase 1-2 Trial",TERMINATED,,PHASE1,13.0,ACTUAL,Washington University School of Medicine,,2.0,,Ipsen bought out Epizyme,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,OTHER,,,,,,,2024,0.0
NCT03724071,,2018-10-16,,,2023-06-21,2018-10-29,2018-10-30,ACTUAL,,,,,,,2023-06-21,2023-06-23,ACTUAL,2018-10-16,ACTUAL,2018-10-16,2023-06,2023-06-30,2023-02-23,ACTUAL,2023-02-23,2023-02-23,ACTUAL,2023-02-23,,INTERVENTIONAL,,,Study of TG6002 (VV TK-RR-FCU1) in Combination With 5-FC in Patients With Advanced Gastro-intestinal Tumors.,A Phase I/IIa Study of TG6002 (VV TK-RR-FCU1) Administered by Intravenous (IV) Infusions in Combination With Oral Flucytosine (5-FC) in Patients With Advanced Gastro-intestinal (GI) Tumors.,TERMINATED,,PHASE1/PHASE2,51.0,ACTUAL,Transgene,,3.0,,Study has been terminated after Phase I part on 23 February 2023,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,INDUSTRY,,,,,,,2023,0.0
NCT04803227,,2021-02-12,,,2021-12-14,2021-03-16,2021-03-17,ACTUAL,,,,,,,2021-12-14,2022-01-04,ACTUAL,2021-03-11,ACTUAL,2021-03-11,2021-12,2021-12-31,2021-05-28,ACTUAL,2021-05-28,2021-05-28,ACTUAL,2021-05-28,,INTERVENTIONAL,,,Safety and Tolerability of Emricasan in Symptomatic Outpatients Diagnosed With Mild-COVID-19,Safety and Tolerability of Emricasan in Symptomatic Outpatients Diagnosed With Mild-COVID-19,TERMINATED,,PHASE1,13.0,ACTUAL,Histogen,,2.0,,Unforeseeable difficulties in recruiting patients. There were no reported serious adverse events.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,INDUSTRY,,,,,,,2021,0.0
NCT03759366,,2018-11-26,2022-08-01,,2023-11-28,2018-11-28,2018-11-30,ACTUAL,2022-08-01,2022-08-25,ACTUAL,,,,2023-11-28,2023-12-18,ACTUAL,2018-12-21,ACTUAL,2018-12-21,2023-11,2023-11-30,2023-11-06,ACTUAL,2023-11-06,2022-01-06,ACTUAL,2022-01-06,,INTERVENTIONAL,,Full analysis set included all participants who received at least 1 dose of eculizumab.,A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG),"An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients With Refractory Generalized Myasthenia Gravis",COMPLETED,,PHASE3,11.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,INDUSTRY,,,,,,,2023,1.0
NCT03117634,,2017-04-06,2020-08-12,,2021-08-17,2017-04-12,2017-04-18,ACTUAL,2021-08-17,2021-08-18,ACTUAL,,,,2021-08-17,2021-08-18,ACTUAL,2017-12-01,ACTUAL,2017-12-01,2021-08,2021-08-31,2021-01-31,ACTUAL,2021-01-31,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,An Open Label-study to Compare the Efficacy of Aflibercept Monotherapy for Polypoidal Choroidal Vasculopathy,An Open Label-study to Compare the Efficacy of Aflibercept Monotherapy for Polypoidal Choroidal Vasculopathy Using a Modified Intensive Treat and Extend Regime to a Fixed Dosing Regimen,COMPLETED,,PHASE4,54.0,ACTUAL,Singapore National Eye Centre,"More participants in the personalised group(3:1)increased the power to detect outcomes. 52 week study duration may not fully demonstrate the advantages of a TNE regimen,PL closure. Study not powered to detect the difference in PL closure at month 3.",2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,OTHER_GOV,,,,,,,2021,1.0
NCT05274269,,2022-03-01,2024-07-03,,2024-07-31,2022-03-01,2022-03-10,ACTUAL,2024-07-31,2024-08-01,ACTUAL,,,,2024-07-31,2024-08-01,ACTUAL,2022-05-09,ACTUAL,2022-05-09,2024-07,2024-07-31,2023-07-05,ACTUAL,2023-07-05,2023-07-05,ACTUAL,2023-07-05,,INTERVENTIONAL,,All participants who received at least one dose of the study drug were included in the baseline analysis.,Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation,"A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation",COMPLETED,,PHASE3,307.0,ACTUAL,Vertex Pharmaceuticals Incorporated,,2.0,,,f,,,,,t,f,,,t,,,,,,NO,Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,INDUSTRY,,,,,,,2023,1.0
NCT05112536,,2021-10-06,2023-10-31,,2024-03-11,2021-10-27,2021-11-09,ACTUAL,2024-03-11,2024-03-12,ACTUAL,,,,2024-03-11,2024-03-12,ACTUAL,2022-03-03,ACTUAL,2022-03-03,2023-12,2023-12-31,2023-03-13,ACTUAL,2023-03-13,2022-10-31,ACTUAL,2022-10-31,,INTERVENTIONAL,,,"Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer","A Phase 2, Open-Label, Single-Arm Study of Single-Dose Lead-In and Neoadjuvant Trilaciclib and Chemotherapy in Patients With Early-Stage Triple Negative Breast Cancer (TNBC)",COMPLETED,,PHASE2,24.0,ACTUAL,"G1 Therapeutics, Inc.",A limitation of this study was the small number of participants.,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,INDUSTRY,,,,,,,2023,1.0
NCT04675242,,2020-12-15,2022-09-21,,2023-06-15,2020-12-15,2020-12-19,ACTUAL,2022-11-17,2022-12-14,ACTUAL,,,,2023-06-15,2023-06-18,ACTUAL,2020-12-14,ACTUAL,2020-12-14,2023-06,2023-06-30,2021-06-30,ACTUAL,2021-06-30,2021-06-16,ACTUAL,2021-06-16,,INTERVENTIONAL,Mississippi,Study Eye,Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis,"Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension, 0.1% QD for the Treatment of Acute Exacerbations of Blepharitis (Mississippi)",COMPLETED,,PHASE2,224.0,ACTUAL,"Nicox Ophthalmics, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,INDUSTRY,,,,,,,2021,1.0
NCT04701190,,2021-01-06,,,2022-01-17,2021-01-06,2021-01-08,ACTUAL,,,,,,,2022-01-17,2022-02-01,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2022-01,2022-01-31,2021-12-15,ACTUAL,2021-12-15,2021-12-15,ACTUAL,2021-12-15,,INTERVENTIONAL,,,Different Noradrenaline Protocols in Post Spinal Hypotension in CS,"Comparison of Different Noradrenaline Protocols to Prevent Post Spinal Hypotension During Elective Caesarean Delivery: A Randomised, Double-blind Clinical Trial",COMPLETED,,PHASE4,180.0,ACTUAL,Ankara University,,3.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,OTHER,,,,,,,2021,1.0
NCT03239080,,2017-08-01,,,2020-11-23,2017-08-01,2017-08-03,ACTUAL,,,,,,,2020-11-23,2020-11-24,ACTUAL,2017-06-19,ACTUAL,2017-06-19,2020-11,2020-11-30,2020-05-24,ACTUAL,2020-05-24,2020-05-24,ACTUAL,2020-05-24,,INTERVENTIONAL,,,Effect of Denosumab in Erosion Healing in RA,Effect of RANKL Inhibition on Healing of Bone Erosion in Rheumatoid Arthritis Using HR-pQCT,COMPLETED,,PHASE2,110.0,ACTUAL,Chinese University of Hong Kong,,2.0,,,f,,,,t,f,f,,,t,,,,,,,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,OTHER,,,,,,,2020,1.0
NCT04155099,,2019-08-21,,,2023-09-29,2019-11-04,2019-11-07,ACTUAL,,,,,,,2023-09-29,2023-10-03,ACTUAL,2021-03-01,ACTUAL,2021-03-01,2023-09,2023-09-30,2023-07-30,ACTUAL,2023-07-30,2023-07-30,ACTUAL,2023-07-30,,INTERVENTIONAL,,,Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy,Assessment of Cognitive Ability and the Intestinal Microbiome in Individuals With Liver Disease Before and After Investigational Microbiota Restoration Therapeutic,TERMINATED,,PHASE2,5.0,ACTUAL,Ochsner Health System,,3.0,,Unable to recruit participants,,,,,,t,f,,,,,,,,,NO,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,OTHER,,,,,,,2023,0.0
NCT05234606,,2022-01-13,,,2022-04-04,2022-02-01,2022-02-10,ACTUAL,,,,,,,2022-04-04,2022-04-12,ACTUAL,2022-03,ESTIMATED,2022-03-31,2022-04,2022-04-30,2022-03-31,ACTUAL,2022-03-31,2022-03-31,ACTUAL,2022-03-31,,INTERVENTIONAL,,,A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors,"A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Subjects With Advanced Solid Tumors Associated With Nectin-4 Expression",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Silverback Therapeutics,,4.0,,Sponsor decision based on strategic re-alignment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,INDUSTRY,,,,,,,2022,0.0
NCT03712787,,2018-10-18,2022-08-25,,2022-08-25,2018-10-18,2018-10-19,ACTUAL,2022-08-25,2022-09-22,ACTUAL,,,,2022-08-25,2022-09-22,ACTUAL,2019-03-22,ACTUAL,2019-03-22,2022-08,2022-08-31,2021-09-30,ACTUAL,2021-09-30,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,,Safety Data Set: All participants who received at least 1 dose of study drug in M15-570.,An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD),An Extension Study of ABBV-8E12 in Early Alzheimer's Disease,TERMINATED,,PHASE2,364.0,ACTUAL,AbbVie,Study M15-570 was discontinued because of lack of efficacy in the parent study (Study M15-566) and 2) the tilavonemab development program was discontinued.,4.0,,Discontinued because of lack of efficacy in the parent study (Study M15-566; NCT02880956).,f,,,,t,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,INDUSTRY,,,,,,,2021,0.0
NCT04502667,,2020-08-04,,,2022-04-07,2020-08-04,2020-08-06,ACTUAL,,,,,,,2022-04-07,2022-04-08,ACTUAL,2020-07-15,ACTUAL,2020-07-15,2022-04,2022-04-30,2021-09-15,ACTUAL,2021-09-15,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,COVID-19,,Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19,Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19: Open Controlled Clinical Trial,COMPLETED,,PHASE3,45.0,ACTUAL,"Coordinación de Investigación en Salud, Mexico",,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,OTHER_GOV,,,,,,,2021,1.0
NCT03644459,,2018-08-03,,,2020-03-10,2018-08-21,2018-08-23,ACTUAL,,,,,,,2020-03-10,2020-03-11,ACTUAL,2019-04-03,ACTUAL,2019-04-03,2020-03,2020-03-31,2020-08,ESTIMATED,2020-08-31,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,Safety and Efficacy of the Fully Humanized Anti - VEGF Monoclonal Antibody LYN00101,"Phase I Study of the Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of the Fully Humanized Anti - VEGF Monoclonal Antibody LYN00101 With Blocking of Autocrine Loops VEGFR1/2/3",WITHDRAWN,,PHASE1,0.0,ACTUAL,Lynkcell Inc.,,1.0,,Unable to recruit individuals for the study,f,,,,f,f,f,,,,,,,,,,,2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,OTHER,,,,,,,2020,0.0
NCT03782376,,2018-12-11,2023-08-16,,2024-02-20,2018-12-19,2018-12-20,ACTUAL,2023-08-16,2023-09-13,ACTUAL,,,,2024-02-20,2024-02-22,ACTUAL,2018-12-20,ACTUAL,2018-12-20,2024-02,2024-02-29,2023-01-10,ACTUAL,2023-01-10,2022-08-19,ACTUAL,2022-08-19,,INTERVENTIONAL,POWER,,A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease,"A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease",COMPLETED,,PHASE3,215.0,ACTUAL,Janssen-Cilag Ltd.,"Some exploratory endpoints including endoscopic assessments for baseline and Week 16, and clinical data for 24 weeks are not reported in this summary and will be included in the manuscript.",2.0,,,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials\\transparency.~As noted on this site, requests for access to the study data can be submitted through Yale open and Access (YODA) Project site at yoda.yale.edu",2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,INDUSTRY,,,,,,,2023,1.0
NCT05249569,,2022-02-03,2023-02-08,,2023-04-28,2022-02-18,2022-02-21,ACTUAL,2023-04-28,2023-05-03,ACTUAL,,,,2023-04-28,2023-05-03,ACTUAL,2022-11-04,ACTUAL,2022-11-04,2023-04,2023-04-30,2022-12-30,ACTUAL,2022-12-30,2022-12-30,ACTUAL,2022-12-30,,INTERVENTIONAL,,"One patient signed consent and was enrolled on study. However, the sponsor that was planning to provide one of the study drugs decided they no longer wanted to supply the drug for this project. The participant that was enrolled on the study did not receive treatment before the study was terminated.","Study of Bavituximab, Axitinib, and Avelumab in Advanced Hepatocellular Carcinoma","Multi-center Phase II Open-label Study of Bavituximab, Axitinib, and Avelumab in Advanced Hepatocellular Carcinoma",TERMINATED,,PHASE2,1.0,ACTUAL,University of Texas Southwestern Medical Center,,1.0,,Sponsor pulled support for one of the study drugs.,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,OTHER,,,,,,,2022,0.0
NCT02225275,,2014-08-22,2022-05-17,,2022-09-13,2014-08-22,2014-08-26,ESTIMATED,2022-09-13,2022-09-28,ACTUAL,,,,2022-09-13,2022-09-28,ACTUAL,2016-03-31,ACTUAL,2016-03-31,2022-09,2022-09-30,2021-05-19,ACTUAL,2021-05-19,2021-05-19,ACTUAL,2021-05-19,,INTERVENTIONAL,,,Lenalidomide and Obinutuzumab in Treating Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma,Combination of Lenalidomide and Obinutuzumab (GA101) in Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL),TERMINATED,,PHASE2,9.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Due to slow accrual,f,,,,f,t,f,,,,,,,,,,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,OTHER,,,,,,,2021,0.0
NCT04822298,,2021-03-26,2024-01-16,,2024-01-16,2021-03-26,2021-03-30,ACTUAL,2024-01-16,2024-07-05,ACTUAL,,,,2024-01-16,2024-07-05,ACTUAL,2021-08-31,ACTUAL,2021-08-31,2024-01,2024-01-31,2022-01-26,ACTUAL,2022-01-26,2021-12-08,ACTUAL,2021-12-08,,INTERVENTIONAL,,Safety analysis set: defined as all participants that were enrolled and receive at least 1 dose of AMG 160.,Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer,"A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 160 in Subjects With Non-Small Cell Lung Cancer",TERMINATED,,PHASE1,3.0,ACTUAL,Amgen,,3.0,,Amgen made a business decision to discontinue AMG 160 20180273,f,,,,,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,INDUSTRY,,,,,,,2022,0.0
NCT02657889,,2016-01-08,2019-12-17,,2022-11-07,2016-01-13,2016-01-18,ESTIMATED,2020-02-04,2020-02-11,ACTUAL,,,,2022-11-07,2022-12-01,ACTUAL,2016-04-15,ACTUAL,2016-04-15,2022-11,2022-11-30,2021-09-17,ACTUAL,2021-09-17,2018-05-14,ACTUAL,2018-05-14,,INTERVENTIONAL,TOPACIO,The Baseline analysis Population consisted of all participants who received at least one dose of study medication.,Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer,Phase 1/2 Clinical Study of Niraparib in Combination With Pembrolizumab (MK-3475) in Patients With Advanced or Metastatic Triple-Negative Breast Cancer and in Patients With Recurrent Ovarian Cancer,COMPLETED,,PHASE1/PHASE2,122.0,ACTUAL,"Tesaro, Inc.",,1.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-15 02:12:28.312598,2024-10-15 02:12:28.312598,INDUSTRY,,,,,,,2021,1.0
NCT04212169,,2019-11-04,2023-07-19,,2023-08-31,2019-12-24,2019-12-26,ACTUAL,2023-08-31,2023-09-28,ACTUAL,,,,2023-08-31,2023-09-28,ACTUAL,2019-12-09,ACTUAL,2019-12-09,2023-08,2023-08-31,2022-09-20,ACTUAL,2022-09-20,2022-07-21,ACTUAL,2022-07-21,,INTERVENTIONAL,,,Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis,"A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI3506 in Adult Subjects With Moderate-to-severe Atopic Dermatitis",COMPLETED,,PHASE2,148.0,ACTUAL,AstraZeneca,,4.0,,,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,INDUSTRY,,,,,,,2022,1.0
NCT03871153,,2019-03-05,2023-10-06,,2023-10-06,2019-03-08,2019-03-12,ACTUAL,2023-10-06,2023-11-01,ACTUAL,,,,2023-10-06,2023-11-01,ACTUAL,2019-08-02,ACTUAL,2019-08-02,2023-10,2023-10-31,2022-03-09,ACTUAL,2022-03-09,2021-10-30,ACTUAL,2021-10-30,,INTERVENTIONAL,,,Chemoradiation Plus Durvalumab Followed by Surgery Followed by Adjuvant Durvalumab in Patients With Surgically Resectable Stage III (N2) Non-Small Cell Lung Cancer,A Phase II Study of Concurrent Chemoradiation Plus Durvalumab (MEDI4736) Followed by Surgery Followed by Adjuvant Durvalumab (MEDI4736) in Medically Operable Patients With Surgically Resectable Stage III (N2) Non-Small Cell Lung Cancer,TERMINATED,,PHASE2,7.0,ACTUAL,Hoosier Cancer Research Network,,1.0,,Investigator decided to halt study due to low accrual.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,OTHER,,,,,,,2022,0.0
NCT00062868,,2003-06-17,2020-01-15,,2020-05-26,2003-06-17,2003-06-18,ESTIMATED,2020-02-02,2020-02-07,ACTUAL,,,,2020-05-26,2020-06-09,ACTUAL,2003-09,ACTUAL,2003-09-30,2020-05,2020-05-31,2020-04,ACTUAL,2020-04-30,2014-04,ACTUAL,2014-04-30,,INTERVENTIONAL,ALCI,The number of participants analyzed is zero if there were no participants treated in the arm/group/dose.,LMP-specific T-cells for Patients With Relapsed EBV-positive Lymphoma,Administration of LMP-Specific Cytotoxic T-Lymphocytes to Patients With Relapsed EBV-Positive Lymphoma (ALCI) / Previously Known as: Administration of Neomycin Resistance Gene Marked LMP2A-Specific Cytotoxic T-Lymphocytes to Patents With Relapsed EBV-Positive Lymphoma (ALASCAR),COMPLETED,,PHASE1,74.0,ACTUAL,Baylor College of Medicine,,9.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,OTHER,,,,,,,2020,1.0
NCT04169360,,2019-11-05,,,2021-01-25,2019-11-16,2019-11-19,ACTUAL,,,,,,,2021-01-25,2021-01-28,ACTUAL,2021-01,ESTIMATED,2021-01-31,2021-01,2021-01-31,2021-01-12,ACTUAL,2021-01-12,2021-01-12,ACTUAL,2021-01-12,,INTERVENTIONAL,SEARCH,,Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder,Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of Maryland, Baltimore",,2.0,,"The FDA determined that there is not adequate safety information to continue clinical investigations using ANS-6637 and Amygdala Neurosciences, the product company of ANS-6637, is no longer pursuing research with this compound.",f,,,,,t,f,,,,,,"Data will be available at the time of publication or shortly thereafter, and will be kept indefinitely.",Will be determined by Principal Investigator,,YES,"The investigator will share de-identified data with approved outside collaborators under appropriate agreements, at the time of publication or shortly thereafter.",2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,OTHER,,,,,,,2021,0.0
NCT04807829,,2021-03-17,,,2021-09-15,2021-03-17,2021-03-19,ACTUAL,,,,,,,2021-09-15,2021-09-22,ACTUAL,2021-04,ESTIMATED,2021-04-30,2021-09,2021-09-30,2022-04,ESTIMATED,2022-04-30,2022-04,ESTIMATED,2022-04-30,,INTERVENTIONAL,,,Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation,A Randomized-Controlled Trial With the Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation,WITHDRAWN,,PHASE2,0.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,The study was stopped due to drug unavailability. The drug is unavailable because production was discontinued in the US.,f,,,,,t,f,,,,,,,,,,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,OTHER,,,,,,,2022,0.0
NCT04798703,,2020-12-02,,,2021-03-13,2021-03-12,2021-03-15,ACTUAL,,,,,,,2021-03-13,2021-03-17,ACTUAL,2017-05-24,ACTUAL,2017-05-24,2020-12,2020-12-31,2020-11-18,ACTUAL,2020-11-18,2020-05-04,ACTUAL,2020-05-04,,INTERVENTIONAL,,,Study of ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID),Phase I Exploratory Study of ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID) Administered for 12 Consecutive Weeks Followed by Maintenance Therapy in BCG Unresponsive/ Intolerant Patients With Bladder Carcinoma in Situ (CIS),COMPLETED,,PHASE1,20.0,ACTUAL,Fidia Farmaceutici s.p.a.,,1.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,INDUSTRY,,,,,,,2020,1.0
NCT04746430,,2021-02-08,,,2021-05-07,2021-02-08,2021-02-09,ACTUAL,,,,,,,2021-05-07,2021-05-11,ACTUAL,2021-02-16,ACTUAL,2021-02-16,2021-05,2021-05-31,2021-04-23,ACTUAL,2021-04-23,2021-04-23,ACTUAL,2021-04-23,,INTERVENTIONAL,COPPER,,COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study,COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study: an Open-label Randomized Controlled Trial,TERMINATED,,PHASE4,17.0,ACTUAL,General Practitioners Research Institute,,2.0,,Too few patients,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,NETWORK,,,,,,,2021,0.0
NCT03115567,,2017-02-15,2022-11-01,,2023-05-13,2017-04-11,2017-04-14,ACTUAL,2023-05-13,2023-05-17,ACTUAL,,,,2023-05-13,2023-05-17,ACTUAL,2017-02-16,ACTUAL,2017-02-16,2023-05,2023-05-31,2022-09-02,ACTUAL,2022-09-02,2020-04-24,ACTUAL,2020-04-24,,INTERVENTIONAL,,,A Study of Topical Steroids as Preemptive Therapy for EGFR Inhibitor-Induced Papulopustular Eruption,A Randomized Phase II Study of Topical Steroids as Preemptive Therapy for Epidermal Growth Factor Receptor Inhibitor-Induced Papulopustular Eruption,TERMINATED,,PHASE2,14.0,ACTUAL,Northwestern University,,2.0,,Low enrollment accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,OTHER,,,,,,,2022,0.0
NCT04428021,,2020-06-07,,,2022-02-21,2020-06-10,2020-06-11,ACTUAL,,,,,,,2022-02-21,2022-02-23,ACTUAL,2020-06-15,ACTUAL,2020-06-15,2022-02,2022-02-28,2021-10-31,ACTUAL,2021-10-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,PLACO-COVID,,Standard or Convalescent Plasma in Patients With Recent Onset of COVID-19 Respiratory Failure,"Effectiveness of Adding Standard Plasma or COVID-19 Convalescent Plasma to Standard Treatment, Versus Standard Treatment Alone, in Patients With Recent Onset of COVID-19 Respiratory Failure. A Randomized, Three-arms, Phase 2 Trial",COMPLETED,,PHASE2,180.0,ACTUAL,A.O.U. Città della Salute e della Scienza,,3.0,,,f,,,,t,f,f,,,,,,Data will be available after 12 months from study ending and for the following 5 years,Data requests should be submitted to the corresponding author for consideration.,,YES,"All Individual Participant Data requests should be submitted to the corresponding author for consideration. Access to deidentified participant data may be granted following review, after the publication of major results",2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,OTHER,,,,,,,2021,0.0
NCT02115464,,2014-04-14,,,2020-04-21,2014-04-14,2014-04-16,ESTIMATED,,,,,,,2020-04-21,2020-04-22,ACTUAL,2014-12-17,ACTUAL,2014-12-17,2020-04,2020-04-30,2020-04-21,ACTUAL,2020-04-21,2020-03-09,ACTUAL,2020-03-09,,INTERVENTIONAL,ALMERA,,Advanced Lung Cancer Treatment With Metformin and Chemo-Radiotherapy,A Phase II Study to Investigate a Combination of Metformin With Chemo-Radiotherapy in Patients With Locally Advanced Non-Small Cell Lung Cancer,TERMINATED,,PHASE2,54.0,ACTUAL,Ontario Clinical Oncology Group (OCOG),,2.0,,The accrual rate was not high enough to reach the target sample size.,f,,,,t,f,f,,,,,,,,,,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,OTHER,,,,,,,2020,0.0
NCT04153188,,2019-11-04,2022-02-23,,2022-03-18,2019-11-05,2019-11-06,ACTUAL,2022-02-23,2022-03-18,ACTUAL,,,,2022-03-18,2022-03-31,ACTUAL,2019-01-15,ACTUAL,2019-01-15,2022-03,2022-03-31,2021-01-05,ACTUAL,2021-01-05,2020-11-13,ACTUAL,2020-11-13,,INTERVENTIONAL,,,Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride (HCL) 1% Cream for Erythematotelangiectatic Rosacea,"Pilot Study to Evaluate Vbeam® Prima Pulsed Dye Laser (PDL) Treatment and RHOFADE® (Oxymetazoline HCL, 1% Cream) for Erythematotelangiectatic Rosacea",COMPLETED,,PHASE4,34.0,ACTUAL,Candela Corporation,Small sample size for randomization,2.0,,,f,,,,f,t,t,,,f,,,,,,NO,,2024-10-16 03:19:48.593949,2024-10-16 03:19:48.593949,INDUSTRY,,,,,,,2021,1.0
NCT02427841,,2015-04-17,2020-10-26,,2023-08-14,2015-04-22,2015-04-28,ESTIMATED,2021-01-11,2021-01-14,ACTUAL,,,,2023-08-14,2023-09-06,ACTUAL,2016-01-21,ACTUAL,2016-01-21,2023-08,2023-08-31,2022-12-12,ACTUAL,2022-12-12,2019-11-12,ACTUAL,2019-11-12,,INTERVENTIONAL,,,Nab-paclitaxel and Gemcitabine Hydrochloride Followed by Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery,Phase 2 Study of Preoperative Chemotherapy With Abraxane and Gemcitabine Followed by Chemoradiation for Borderline Resectable or Node-Positive Pancreatic Cancer,COMPLETED,,PHASE2,20.0,ACTUAL,OHSU Knight Cancer Institute,"Study closed early due to lack of enrollment. Study was expected to enrolled 44 evaluable patients to achieve 83% power using the 2-sided binomial test at 10% significance. Study enrolled only 19 evaluable patients, meaning the study was underpowered at \< 62%. Study completed stage 1 of Simon's 2-stage minimax design and achieved the required goal of 8 R0 resections.",1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,OTHER,,,,,,,2022,1.0
NCT04435808,,2020-06-04,2020-08-10,,2022-02-10,2020-06-16,2020-06-17,ACTUAL,2020-11-12,2020-11-16,ACTUAL,,,,2022-02-10,2022-02-14,ACTUAL,2020-04-14,ACTUAL,2020-04-14,2022-02,2022-02-28,2020-07-15,ACTUAL,2020-07-15,2020-07-15,ACTUAL,2020-07-15,,INTERVENTIONAL,,DSMB stopped the study,Efficacy of Hydroxychloroquine Prophylaxis for Health Care Workers at High Risk for COVID-19,Off Label Study to Evaluate the Efficacy of Hydroxychloroquine as Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Health Care Workers at High Risk of Occupational Exposure to SARS-CoV-2,TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,University of New Mexico,,2.0,,Stopped for futility by DSMB,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,OTHER,,,,,,,2020,0.0
NCT02737475,,2016-04-08,2021-11-02,,2021-12-25,2016-04-08,2016-04-14,ESTIMATED,2021-12-25,2022-01-25,ACTUAL,,,,2021-12-25,2022-01-25,ACTUAL,2016-06-17,ACTUAL,2016-06-17,2021-12,2021-12-31,2020-11-02,ACTUAL,2020-11-02,2020-11-02,ACTUAL,2020-11-02,,INTERVENTIONAL,,,An Investigational Immuno-Therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Participants With Solid Cancers That Are Advanced or Have Spread,A Phase 1/2a Study of BMS-986178 Administered Alone or in Combination With Nivolumab and/or Ipilimumab in Subjects With Advanced Solid Tumors,COMPLETED,,PHASE1/PHASE2,166.0,ACTUAL,Bristol-Myers Squibb,,9.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,INDUSTRY,,,,,,,2020,0.0
NCT03782363,,2018-12-17,,,2020-12-18,2018-12-18,2018-12-20,ACTUAL,,,,,,,2020-12-18,2020-12-22,ACTUAL,2020-12-18,ACTUAL,2020-12-18,2020-12,2020-12-31,2023-04-01,ESTIMATED,2023-04-01,2023-04-01,ESTIMATED,2023-04-01,,INTERVENTIONAL,CAST,,Study of Adoptive Immunotherapy in Relapsed and Non-resectable Sarcomas After Multimodal Treatment.,A Phase I Study of Adoptive Immunotherapy With Cytokine-Induced Killer Cells in Relapsed and Non-resectable Sarcomas After Multimodal Treatment.,WITHDRAWN,,PHASE1,0.0,ACTUAL,Italian Sarcoma Group,,4.0,,Initial version of the protocol not submitted and new version approved has a new sponsor and it has been added into Clinicaltrials by the new sponsor,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,NETWORK,,,,,,,2023,0.0
NCT03428100,,2018-02-05,2020-11-26,,2024-04-18,2018-02-05,2018-02-09,ACTUAL,2021-01-15,2021-01-19,ACTUAL,,,,2024-04-18,2024-05-14,ACTUAL,2018-05-15,ACTUAL,2018-05-15,2024-04-15,2024-04-15,2023-04-20,ACTUAL,2023-04-20,2019-11-25,ACTUAL,2019-11-25,,INTERVENTIONAL,BREEZE-AD4,All randomized participants.,A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable,"A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Baricitinib in Combination With Topical Corticosteroids in Adult Patients With Moderate-to-Severe Atopic Dermatitis Who Have Experienced Failure to Cyclosporine or Are Intolerant to, or Have Contraindication to, Cyclosporine",COMPLETED,,PHASE3,463.0,ACTUAL,Eli Lilly and Company,,19.0,,,f,,,,t,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,INDUSTRY,,,,,,,2023,1.0
NCT04370236,,2020-04-29,,,2022-03-03,2020-04-29,2020-04-30,ACTUAL,,,,,,,2022-03-03,2022-03-18,ACTUAL,2020-10-21,ACTUAL,2020-10-21,2022-03,2022-03-31,2021-11-18,ACTUAL,2021-11-18,2021-10-13,ACTUAL,2021-10-13,,INTERVENTIONAL,,,INB03 for the Treatment of Pulmonary Complications From COVID-19,"A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of INB03 in the Treatment of Participants With Pulmonary Complications From Coronavirus Disease (COVID-19)",TERMINATED,,PHASE2/PHASE3,79.0,ACTUAL,"Inmune Bio, Inc.",,2.0,,Futility,,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,INDUSTRY,,,,,,,2021,0.0
NCT03713684,,2018-10-18,2021-11-04,,2021-11-04,2018-10-18,2018-10-22,ACTUAL,2021-11-04,2021-12-02,ACTUAL,,,,2021-11-04,2021-12-02,ACTUAL,2018-11-09,ACTUAL,2018-11-09,2021-11,2021-11-30,2021-01-04,ACTUAL,2021-01-04,2020-11-20,ACTUAL,2020-11-20,,INTERVENTIONAL,AMPLITUDE-L,"Analysis was performed on Intent-to-treat (ITT) population which included all participants randomized irrespective of compliance with the study protocol and procedures analyzed, according to the treatment group allocated by randomization.",Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s),"A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)",TERMINATED,,PHASE3,370.0,ACTUAL,Sanofi,"The study was terminated early by the Sponsor on 09 September 2020. Due to early termination of the study, few efficacy evaluations originally planned in the protocol were no longer considered to be relevant and were not performed. Primary, and secondary efficacy data were descriptively summarized and data were carefully considered given that the study was terminated early.",4.0,,"Sponsor decision to cancel TRIAL, not related to safety concern",f,,,,t,t,f,,,,,,,,,NO,No plan to share individual participant data (IPD) by SANOFI: Product rights transferred to Hanmi Pharmaceutical.,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,INDUSTRY,,,,,,,2021,0.0
NCT04644029,,2020-11-23,2024-06-26,,2024-08-06,2020-11-23,2020-11-25,ACTUAL,2024-08-06,2024-08-09,ACTUAL,,,,2024-08-06,2024-08-09,ACTUAL,2021-02-24,ACTUAL,2021-02-24,2024-08,2024-08-31,2024-06-11,ACTUAL,2024-06-11,2023-07-18,ACTUAL,2023-07-18,,INTERVENTIONAL,Impower-022,The baseline characteristics population includes all randomized participants who received study drug.,Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022),"A Phase 3, Randomized, Active-Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Women at High Risk for HIV-1 Infection",TERMINATED,,PHASE3,730.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,Voluntarily terminated due to benefit/risk assessment,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,INDUSTRY,,,,,,,2024,0.0
NCT02501811,,2015-07-15,2021-02-22,,2021-03-29,2015-07-15,2015-07-17,ESTIMATED,2021-03-29,2021-04-26,ACTUAL,,,,2021-03-29,2021-04-26,ACTUAL,2015-10,,2015-10-31,2021-03,2021-03-31,2020-07-22,ACTUAL,2020-07-22,2020-06-25,ACTUAL,2020-06-25,,INTERVENTIONAL,CONCERT-HF,Denominators are of those reporting,Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure,"A Phase II, Randomized, Placebo-Controlled Study of the Safety, Feasibility, & Efficacy of Autologous Mesenchymal Stem Cells & C-kit+ Cardiac Stem Cells, Alone or in Combination, Administered Transendocardially in Subjects With Ischemic HF",COMPLETED,,PHASE2,125.0,ACTUAL,"The University of Texas Health Science Center, Houston","Relatively small group sizes overall. Relatively long interval between harvest visit and study product injection (approx. 14wks) resulting in patient attrition. Failure of cells to grow from tissue of some patients, resulting in some patients crossing over into other treatment groups.",4.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 16:18:50.981187,2024-10-15 16:18:50.981187,OTHER,,,,,,,2020,1.0
NCT03654989,,2018-08-20,,,2023-12-05,2018-08-29,2018-08-31,ACTUAL,,,,,,,2023-12-05,2023-12-12,ACTUAL,2020-01-28,ACTUAL,2020-01-28,2023-12,2023-12-31,2021-12-07,ACTUAL,2021-12-07,2021-12-07,ACTUAL,2021-12-07,,INTERVENTIONAL,InTREPiD,,Iontophoresis of Treprostinil to Enhance Wound Healing in Diabetic Foot Skin Ulcers,Iontophoresis of Treprostinil to Enhance Wound Healing in Diabetic Foot Skin Ulcers,TERMINATED,,PHASE1/PHASE2,4.0,ACTUAL,"University Hospital, Grenoble",,3.0,,recruitment difficulties,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,OTHER,,,,,,,2021,0.0
NCT04702464,,2020-12-23,,,2021-11-17,2021-01-07,2021-01-11,ACTUAL,,,,,,,2021-11-17,2021-11-29,ACTUAL,2021-01-12,ACTUAL,2021-01-12,2021-11,2021-11-30,2021-05-13,ACTUAL,2021-05-13,2021-05-09,ACTUAL,2021-05-09,,INTERVENTIONAL,,,"A Study to Evaluate the Effect of a Dual CYP2C19 and CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects","A Phase 1, Open-label Study to Evaluate the Effect of a Dual CYP2C19 and CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects",COMPLETED,,PHASE1,29.0,ACTUAL,Celgene,,1.0,,,t,,,,f,t,f,,,,,,See Plan Description,See Plan Description,https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,INDUSTRY,,NCT03723148,AVAILABLE,,,,2021,1.0
NCT03806049,,2019-01-13,,,2021-07-09,2019-01-15,2019-01-16,ACTUAL,,,,,,,2021-07-09,2021-07-15,ACTUAL,2019-12,ESTIMATED,2019-12-31,2019-09,2019-09-30,2024-12,ESTIMATED,2024-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Trial Comparing Niraparib-bevacizumab-Dostarlimab and Niraparib-bevacizumab to Standard of Care in Recurrent Ovarian Cancer,ENGOT-OV42 / NSGO-AVATAR: A Three-arm Randomized Study to Evaluate the Efficacy of Niraparib-bevacizumab-dostarlimab Triplet Combination Against Niraparib-bevacizumab Doublet Combination and Against Standard of Care Therapy in Women With Relapsed Ovarian Cancer Where Platinum Combination Therapy is an Option.,WITHDRAWN,,PHASE3,0.0,ACTUAL,Nordic Society of Gynaecological Oncology - Clinical Trials Unit,,3.0,,Lack of financial support,f,,,,t,f,f,,,,,,,,,NO,All individual participant data will be anonymized,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,OTHER,,,,,,,2024,0.0
NCT04577820,,2020-09-30,,,2021-10-25,2020-09-30,2020-10-08,ACTUAL,,,,,,,2021-10-25,2021-11-01,ACTUAL,2021-10-13,ESTIMATED,2021-10-13,2021-10,2021-10-31,2022-10-08,ESTIMATED,2022-10-08,2022-03-01,ESTIMATED,2022-03-01,,INTERVENTIONAL,,,Study to Assess the Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP),Evaluation of Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva,WITHDRAWN,,PHASE3,0.0,ACTUAL,Regeneron Pharmaceuticals,,1.0,,Phase 2 Study R2477-FOP-1940 has been withdrawn and the next phase of the development program is being planned,f,,,,,t,f,,,t,,,"When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.",Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf,https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,INDUSTRY,,,,,,,2022,0.0
NCT04805671,,2021-03-17,2023-12-07,,2024-01-11,2021-03-17,2021-03-18,ACTUAL,2024-01-11,2024-02-06,ACTUAL,,,,2024-01-11,2024-02-06,ACTUAL,2021-07-26,ACTUAL,2021-07-26,2024-01,2024-01-31,2022-11-03,ACTUAL,2022-11-03,2022-02-10,ACTUAL,2022-02-10,,INTERVENTIONAL,STAMP,The Full Analysis Set includes all randomized participants.,Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19,"A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Treatment of Ambulatory Participants With Mild or Moderate COVID-19 (STAMP)",TERMINATED,,PHASE2/PHASE3,399.0,ACTUAL,"Invivyd, Inc.",,2.0,,"All primary efficacy data has been collected and analyzed. Based on the safety data gathered to date, it has been determined that continued participation by study subjects would not yield any additional beneficial safety information.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,INDUSTRY,,,,,,,2022,0.0
NCT01222247,,2010-10-14,2018-12-18,,2023-03-24,2010-10-14,2010-10-18,ESTIMATED,2019-01-07,2019-01-30,ACTUAL,,,,2023-03-24,2023-03-28,ACTUAL,2010-10,ACTUAL,2010-10-31,2023-03,2023-03-31,2022-08-31,ACTUAL,2022-08-31,2015-03,ACTUAL,2015-03-31,,INTERVENTIONAL,ALPS,,Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial,Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial,COMPLETED,,PHASE3,2831.0,ACTUAL,The George Washington University Biostatistics Center,,2.0,,,f,,,,t,t,f,,,f,,,,,,YES,Data will be shared after completion and publication of the main analyses per NIH policy. Requests can be sent to mfmudatasets@bsc.gwu.edu.,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,OTHER,,,,,,,2022,1.0
NCT05239663,,2022-02-07,,,2024-07-30,2022-02-13,2022-02-15,ACTUAL,,,,,,,2024-07-30,2024-08-01,ACTUAL,2022-02-08,ACTUAL,2022-02-08,2024-07,2024-07-31,2024-07-31,ACTUAL,2024-07-31,2024-07-31,ACTUAL,2024-07-31,,INTERVENTIONAL,,,GM1 Prophylaxis for Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer,The Effects of Ganglioside-Monosialic Acid in Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer: A Randomized Trial,TERMINATED,,PHASE3,76.0,ACTUAL,Sun Yat-sen University,,2.0,,Difficulty accruing subjects the study accrual was closed,f,,,,t,f,f,,,,,,,,,,,2024-10-17 01:19:10.767082,2024-10-17 01:19:10.767082,OTHER,,,,,,,2024,0.0
NCT03168438,,2017-05-24,2021-11-09,,2021-11-09,2017-05-24,2017-05-30,ACTUAL,2021-11-09,2022-01-11,ACTUAL,,,,2021-11-09,2022-01-11,ACTUAL,2017-08-18,ACTUAL,2017-08-18,2021-10,2021-10-31,2020-11-05,ACTUAL,2020-11-05,2020-07-13,ACTUAL,2020-07-13,,INTERVENTIONAL,,,Letetresgene Autoleucel Engineered T Cells Alone and in Combination With Pembrolizumab in NY-ESO-1 Positive Multiple Myeloma,"Open-Label Pilot Study to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered NY-ESO-1 Specific (c259) T Cells Alone or in Combination With Pembrolizumab in HLA-A2+ Subjects With NY-ESO-1 and/or LAGE-1a Positive Relapsed and Refractory Multiple Myeloma",TERMINATED,,PHASE1,6.0,ACTUAL,GlaxoSmithKline,,2.0,,The study was terminated following an internal review of the company's research and development portfolio,f,,,,f,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,INDUSTRY,,,,,,,2020,0.0
NCT03947814,,2019-05-10,,,2022-07-01,2019-05-10,2019-05-13,ACTUAL,,,,,,,2022-07-01,2022-07-05,ACTUAL,2019-07-02,ACTUAL,2019-07-02,2022-07,2022-07-31,2020-09-09,ACTUAL,2020-09-09,2020-09-09,ACTUAL,2020-09-09,,INTERVENTIONAL,,,A Study of Orally Administered Pimodivir in Adult Participants With Renal Impairment,"A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Pimodivir in Adult Subjects",TERMINATED,,PHASE1,29.0,ACTUAL,Janssen-Cilag International NV,,4.0,,Study 63623872FLZ1014 was terminated early based on a strategic business decision by Janssen to end the clinical development program of JNJ-63623872.,f,,,,f,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,INDUSTRY,,,,,,,2020,0.0
NCT04435795,,2020-06-16,2022-04-21,,2022-05-17,2020-06-16,2020-06-17,ACTUAL,2022-04-21,2022-04-29,ACTUAL,,,,2022-05-17,2022-06-10,ACTUAL,2020-09-15,ACTUAL,2020-09-15,2022-05,2022-05-31,2021-07-08,ACTUAL,2021-07-08,2021-06-08,ACTUAL,2021-06-08,,INTERVENTIONAL,CONTAIN,,Inhaled Ciclesonide for Outpatients With COVID19,Ciclesonide Clinical Trial for COVID-19 Treatment,TERMINATED,,PHASE2/PHASE3,215.0,ACTUAL,McGill University Health Centre/Research Institute of the McGill University Health Centre,"We were unable to recruit the intended sample size given a rapid decline in cases of covid-19 in Canada following increases in vaccination.~In addition, we did not enrich the study population for older high risk people and cannot exclude a possible benefit in earlier symptom resolution and prevention of clinical deterioration in this group.~As our trial was stopped prematurely, we might have been underpowered to show a small benefit of ciclesonide on early symptom resolution",2.0,,could not meet target enrolment,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,OTHER,,,,,,,2021,0.0
NCT04697069,,2020-12-23,2022-12-14,,2022-12-14,2021-01-04,2021-01-06,ACTUAL,2022-12-14,2023-01-09,ACTUAL,,,,2022-12-14,2023-01-09,ACTUAL,2021-05-04,ACTUAL,2021-05-04,2022-12,2022-12-31,2021-12-13,ACTUAL,2021-12-13,2021-12-13,ACTUAL,2021-12-13,,INTERVENTIONAL,,Intent-to-Treat (ITT) analysis set included all randomized participants.,A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash,"A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Acneiform Rash in Subjects With Neoplasm Receiving EGFRi or MEKi Therapy",TERMINATED,,PHASE2,4.0,ACTUAL,"AnaptysBio, Inc.",,2.0,,Administrative Reason,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,INDUSTRY,,,,,,,2021,0.0
NCT04020653,,2019-07-12,,,2020-02-28,2019-07-12,2019-07-16,ACTUAL,,,,,,,2020-02-28,2020-03-03,ACTUAL,2019-09-06,ESTIMATED,2019-09-06,2020-02,2020-02-29,2020-09-30,ESTIMATED,2020-09-30,2020-05-31,ESTIMATED,2020-05-31,,INTERVENTIONAL,,,A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria,"A Pilot, Double-blind, Randomized, Parallel-group, Placebo-controlled, Exploratory Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Neopharma Japan Co., Ltd.",,3.0,,"Considering the Thai FDA requirement, changes of Malaria cases in Thailand and EC recommendation, the decision to withdrawal the study was made.",f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,INDUSTRY,,,,,,,2020,0.0
NCT03645603,,2018-08-17,,,2021-10-30,2018-08-22,2018-08-24,ACTUAL,,,,,,,2021-10-30,2021-11-02,ACTUAL,2018-08-30,ACTUAL,2018-08-30,2021-10,2021-10-31,2020-01-18,ACTUAL,2020-01-18,2020-01-18,ACTUAL,2020-01-18,,INTERVENTIONAL,TIP-15-01,,Efficacy and Safety of Dexmedetomidine During Weaning From Analgesia and Sedation in PICU (TIP-15-01),"Efficacy and Safety of Dexmedetomidine During Weaning From Analgesia and Sedation in Pediatric Intensive Care Unit. A Multicenter, Double-blind, Randomized Controlled Trial.",TERMINATED,,PHASE2,45.0,ACTUAL,IRCCS Azienda Ospedaliero-Universitaria di Bologna,,2.0,,futility reasons,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,OTHER,,,,,,,2020,0.0
NCT04536363,,2020-08-29,,,2023-09-13,2020-09-01,2020-09-02,ACTUAL,,,,,,,2023-09-13,2023-09-15,ACTUAL,2020-12-03,ACTUAL,2020-12-03,2023-09,2023-09-30,2020-12-03,ACTUAL,2020-12-03,2020-12-03,ACTUAL,2020-12-03,,INTERVENTIONAL,PGE1-COVID19,,Cri Analog PG1 Effectiveness and Safety in Covid-19,Effectiveness and Safety of the Administration of Intravenous Prostaglandin E1 Analog in the Reduction of Mortality and Complications of Patients With COVID-19,WITHDRAWN,,PHASE2,0.0,ACTUAL,Fundación Santa Fe de Bogota,,2.0,,Delays in approval by the national regulatory authority,f,,,,t,f,f,,,,,,,,,,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,OTHER,,,,,,,2020,0.0
NCT04467281,,2020-07-02,,,2022-06-30,2020-07-08,2020-07-13,ACTUAL,,,,,,,2022-06-30,2022-07-01,ACTUAL,2020-06-30,ACTUAL,2020-06-30,2022-06,2022-06-30,2021-02-26,ACTUAL,2021-02-26,2021-02-26,ACTUAL,2021-02-26,,INTERVENTIONAL,,,A Study of PET/CT Scans With the Radioactive Tracer 89Zr-DFO-Daratumumab in People With Myeloma,A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma: Phase 2 Trial of Clinical Applications,WITHDRAWN,,PHASE2,0.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,PI left institution and study is being transferred.,,,,,,t,f,,,,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,OTHER,,,,,,,2021,0.0
NCT03833063,,2019-02-04,,,2021-08-10,2019-02-05,2019-02-06,ACTUAL,,,,,,,2021-08-10,2021-08-11,ACTUAL,2019-05-01,ESTIMATED,2019-05-01,2019-02,2019-02-28,2020-03-31,ESTIMATED,2020-03-31,2019-12-31,ESTIMATED,2019-12-31,,INTERVENTIONAL,BOTDEP,,Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression,Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression,WITHDRAWN,,PHASE1,0.0,ACTUAL,Helse Stavanger HF,,2.0,,recruitment difficulties due to COVID19,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,OTHER_GOV,,,,,,,2020,0.0
NCT06159686,,2023-11-28,,,2024-03-25,2023-11-28,2023-12-07,ACTUAL,,,,,,,2024-03-25,2024-03-27,ACTUAL,2023-09-15,ACTUAL,2023-09-15,2024-03,2024-03-31,2023-12-08,ACTUAL,2023-12-08,2023-12-08,ACTUAL,2023-12-08,,INTERVENTIONAL,,,The Efficacy of Hemp-containing Cream Versus Placebo in the Treatment of Uremic Pruritus,"This Study Aims to Compare the Efficacy of Hemp-containing Cream and a Placebo in the Treatment of Uremic Pruritus in Hemodialysis Patients. Patients Were Randomly Assigned Either the Hemp-containing Cream or a Placebo and Evaluated the WI-NRS and Skindex-10 Scores at Week 2, 4.",COMPLETED,,PHASE1/PHASE2,60.0,ACTUAL,Thammasat University Hospital,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,OTHER,,,,,,,2023,1.0
NCT04429880,,2020-06-04,,,2022-10-27,2020-06-09,2020-06-12,ACTUAL,,,,,,,2022-10-27,2022-10-31,ACTUAL,2023-01,ESTIMATED,2023-01-31,2022-10,2022-10-31,2024-01,ESTIMATED,2024-01-31,2024-01,ESTIMATED,2024-01-31,,INTERVENTIONAL,,,A Study of Oxytocin PK After IV Administration in Healthy Subjects and Advanced Knee Arthritis Subjects,A Study of Oxytocin Pharmacokinetics After Intravenous Administration in Healthy Subjects and Advanced Knee Arthritis Subjects,WITHDRAWN,,PHASE2,0.0,ACTUAL,Wake Forest University Health Sciences,,1.0,,Study was not initiated; no subjects enrolled. A replacement study will be submitted,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,OTHER,,,,,,,2024,0.0
NCT03576131,,2018-05-08,2022-10-07,,2023-07-31,2018-07-02,2018-07-03,ACTUAL,2022-11-11,2022-12-12,ACTUAL,,,,2023-07-31,2023-08-01,ACTUAL,2018-04-30,ACTUAL,2018-04-30,2023-07,2023-07-31,2021-10-12,ACTUAL,2021-10-12,2021-10-12,ACTUAL,2021-10-12,,INTERVENTIONAL,,Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received.,GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors,"First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1029 in Patients With Malignant Solid Tumors",TERMINATED,,PHASE1/PHASE2,48.0,ACTUAL,Genmab,Results of the biweekly dosing regimens are based on the Clinical Study Report.,1.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,INDUSTRY,,,,,,,2021,0.0
NCT04879017,,2021-04-28,,,2024-04-23,2021-05-04,2021-05-10,ACTUAL,,,,,,,2024-04-23,2024-04-25,ACTUAL,2021-05-11,ACTUAL,2021-05-11,2024-04,2024-04-30,2023-11-30,ACTUAL,2023-11-30,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,,,FHD-286 in Subjects With Metastatic Uveal Melanoma,"A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered FHD-286 in Subjects With Metastatic Uveal Melanoma",TERMINATED,,PHASE1,76.0,ACTUAL,Foghorn Therapeutics Inc.,,1.0,,Sponsor terminated the study for business reasons.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,INDUSTRY,,,,,,,2023,0.0
NCT03286842,,2017-08-17,2022-10-07,,2022-12-22,2017-09-14,2017-09-19,ACTUAL,2022-12-22,2023-01-17,ACTUAL,,,,2022-12-22,2023-01-17,ACTUAL,2018-01-17,ACTUAL,2018-01-17,2022-11,2022-11-30,2021-10-08,ACTUAL,2021-10-08,2021-10-08,ACTUAL,2021-10-08,,INTERVENTIONAL,,The Full Analysis Set consisted of all participants who received at least one dose of study treatment.,To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients.,"A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-ve Metastatic Breast Cancer Patients With Germline or Somatic BRCA1/2 Mutations.",COMPLETED,,PHASE3,256.0,ACTUAL,AstraZeneca,,1.0,,,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,INDUSTRY,,,,,,,2021,1.0
NCT03710642,,2018-10-09,2022-12-08,,2023-01-10,2018-10-16,2018-10-18,ACTUAL,2023-01-10,2023-02-06,ACTUAL,,,,2023-01-10,2023-02-06,ACTUAL,2018-10-23,ACTUAL,2018-10-23,2023-01,2023-01-31,2022-01-05,ACTUAL,2022-01-05,2022-01-05,ACTUAL,2022-01-05,,INTERVENTIONAL,,"Overall number of baseline participants randomized to the clinical trial was a total of 35 participants. After randomization but before Investigational Product administration (IP= prazosin or placebo) one participant was withdrawn from the clinical trial, resulting in a total of 34 participants receiving IP. 26 participants received prazosin, 8 participants received placebo.",Prazosin for Agitation in Alzheimer's Disease,Prazosin for Disruptive Agitation in Alzheimer's Disease (AD) (PEACE-AD),COMPLETED,,PHASE2,35.0,ACTUAL,Alzheimer's Disease Cooperative Study (ADCS),"Following COVID-19, it became clear that it would not be possible to recruit the target sample size of 186 participants exclusively at LTC facilities. In 2021 we adjusted the trial size and incorporated the goal of gathering pilot data to demonstrate the feasibility of enrolling home dwelling participants and using remote visits. These changes resulted in the study sample size being re-estimated. Final enrollment was 35 randomized participants, of which 32 were at home with full time caregiving.",2.0,,,f,,,,t,t,f,,,,,,01 March 2023,"Data requestors must complete an ADCS data and sample sharing request form. Upon approval, requestors must complete a data use agreement prior to accessing the data.",https://www.adcs.org/data-sharing/,YES,"Data sharing is integral to the ADCS's mission to develop and execute innovative clinical trials focused on interventions that may prevent, delay, or treat the expression of Alzheimer's disease and related dementias. The ADCS is committed to sharing resources and tools, including data, biospecimens, trial designs, outcome and analysis measures following NIH guidelines.~DATA SHARING: The ADCS Data and Sample Sharing Committee (DSSC) grants access to de-identified data to individuals who complete the request process and agree to the conditions in an ADCS/UCSD Data Use Agreement (DUA). After approval and receipt of the fully executed DUA, applicants are authorized to acquire data. Non-compliance with the DUA, including the requirement to provide requested updates will jeopardize further access to data.",2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,OTHER,,,,,,,2022,1.0
NCT05556148,,2022-09-22,2023-12-06,,2024-05-10,2022-09-22,2022-09-27,ACTUAL,2024-05-10,2024-05-17,ACTUAL,,,,2024-05-10,2024-05-17,ACTUAL,2022-11-07,ACTUAL,2022-11-07,2024-05,2024-05-31,2022-12-20,ACTUAL,2022-12-20,2022-12-20,ACTUAL,2022-12-20,,INTERVENTIONAL,,The mITT population included all participants who used study product at least once and had data from at least one post-baseline QoL questionnaire to support at least one of the primary endpoint assessments.,Otrivine: Quality of Life (QoL) Impact in a Real-World Setting,A Real-World Evidence Study Evaluating Quality of Life Parameters Following Treatment With Otrivine (Xylometazoline Hydrochloride),COMPLETED,,PHASE4,136.0,ACTUAL,HALEON,,1.0,,,f,,,,f,f,f,,,f,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.",,YES,Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,INDUSTRY,,,,,,,2022,1.0
NCT03410992,,2018-01-19,2021-12-20,2020-01-06,2023-12-15,2018-01-19,2018-01-25,ACTUAL,2022-02-09,2022-03-04,ACTUAL,2022-02-09,2022-03-04,ACTUAL,2023-12-15,2023-12-20,ACTUAL,2018-02-05,ACTUAL,2018-02-05,2023-12,2023-12-31,2020-01-07,ACTUAL,2020-01-07,2018-12-28,ACTUAL,2018-12-28,,INTERVENTIONAL,BE READY,Baseline Characteristics refer to the Randomized Set (RS) which consisted of all randomized study participants.,A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis,"A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis",COMPLETED,,PHASE3,435.0,ACTUAL,UCB Pharma,,3.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,INDUSTRY,,,,,,,2020,1.0
NCT02494583,,2015-07-08,2020-02-28,,2023-03-17,2015-07-08,2015-07-10,ESTIMATED,2020-02-28,2020-03-13,ACTUAL,,,,2023-03-17,2023-04-13,ACTUAL,2015-07-31,ACTUAL,2015-07-31,2023-03,2023-03-31,2022-06-06,ACTUAL,2022-06-06,2019-03-26,ACTUAL,2019-03-26,,INTERVENTIONAL,,,Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062),"A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination With Cisplatin+5-Fluorouracil Versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects With Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma",COMPLETED,,PHASE3,763.0,ACTUAL,Merck Sharp & Dohme LLC,,3.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 12:35:54.067213,2024-10-16 12:35:54.067213,INDUSTRY,,,,,,,2022,1.0
NCT04222816,,2020-01-07,,,2022-01-24,2020-01-07,2020-01-10,ACTUAL,,,,,,,2022-01-24,2022-01-25,ACTUAL,2020-01-16,ACTUAL,2020-01-16,2022-01,2022-01-31,2022-01-07,ACTUAL,2022-01-07,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Effect of Regulated Add -on Sodium Chloride Intake on Stabilization of Serum Lithium Concentration in Bipolar Disorder,Effect of Regulated Add -on Sodium Chloride Intake on Stabilization of Serum Lithium Concentration in Bipolar Disorder: A Randomized Controlled Trial,COMPLETED,,PHASE4,60.0,ACTUAL,"All India Institute of Medical Sciences, Bhubaneswar",,2.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,OTHER,,,,,,,2022,1.0
NCT04880109,,2021-04-29,,,2024-01-15,2021-05-07,2021-05-10,ACTUAL,,,,,,,2024-01-15,2024-01-18,ACTUAL,2021-10-20,ACTUAL,2021-10-20,2024-01,2024-01-31,2022-04-28,ACTUAL,2022-04-28,2022-04-28,ACTUAL,2022-04-28,,INTERVENTIONAL,,,A Phase 2 Study of APX-115 in Hospitalized Patients With Confirmed Mild to Moderate COVID-19.,"A Phase 2, Double-blind, Placebo-controlled, Efficacy, and Safety Study of APX-115 in Hospitalized Patients With Confirmed Mild to Moderate COVID-19.",TERMINATED,,PHASE2,16.0,ACTUAL,"Aptabio Therapeutics, Inc.",,2.0,,Enrollment Challenges,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,INDIV,,,,,,,2022,0.0
NCT03818308,,2019-01-24,,,2021-07-02,2019-01-24,2019-01-28,ACTUAL,,,,,,,2021-07-02,2021-07-06,ACTUAL,2019-05-28,ACTUAL,2019-05-28,2021-01,2021-01-31,2021-06-08,ACTUAL,2021-06-08,2021-06-08,ACTUAL,2021-06-08,,INTERVENTIONAL,,,Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir,Multicenter Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir Fix Dose combination_The HepNet Acute HCV-V Study,COMPLETED,,PHASE2,20.0,ACTUAL,Hannover Medical School,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,OTHER,,,,,,,2021,1.0
NCT05740280,,2023-02-05,,,2023-05-24,2023-02-21,2023-02-23,ACTUAL,,,,,,,2023-05-24,2023-05-26,ACTUAL,2023-01-19,ACTUAL,2023-01-19,2023-05,2023-05-31,2023-08-17,ESTIMATED,2023-08-17,2023-08-17,ESTIMATED,2023-08-17,,INTERVENTIONAL,,,"iCP-NI - Safety, Tolerability, Pharmacokinetic, and Immunogenicity Study in Healthy Male and Female Subjects","iCP-NI - A Phase 1, Double Blind, Placebo Controlled, Single and Multiple Intravenous Infusion, Safety, Tolerability, Pharmacokinetic, and Immunogenicity Study in Healthy Male and Female Subjects",SUSPENDED,,PHASE1,64.0,ESTIMATED,"Cellivery Therapeutics, Inc.",,2.0,,The Sponsor has put the study on hold and will recommence in due time.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,INDUSTRY,,,,,,,2023,0.0
NCT02864290,,2016-06-30,,,2021-10-28,2016-08-09,2016-08-12,ESTIMATED,,,,,,,2021-10-28,2021-10-29,ACTUAL,2016-11-10,ACTUAL,2016-11-10,2021-10,2021-10-31,2020-09-03,ACTUAL,2020-09-03,2020-09-03,ACTUAL,2020-09-03,,INTERVENTIONAL,,,A Study to Evaluate Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML),"A Phase 1 Study Evaluating Safety, Tolerability, and Pharmacokinetics of Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML)",TERMINATED,,PHASE1,43.0,ACTUAL,Astellas Pharma Inc,,6.0,,Study was terminated due to lack of efficacy.,f,,,,f,t,f,,,,,,,,,NO,Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,INDUSTRY,,,,,,,2020,0.0
NCT05191797,,2021-12-29,2024-08-02,,2024-09-21,2021-12-29,2022-01-14,ACTUAL,2024-09-21,2024-09-26,ACTUAL,,,,2024-09-21,2024-09-26,ACTUAL,2022-04-11,ACTUAL,2022-04-11,2024-09,2024-09-30,2024-04-05,ACTUAL,2024-04-05,2023-08-03,ACTUAL,2023-08-03,,INTERVENTIONAL,,,Bomedemstat and Maintenance Immunotherapy for Treatment of Newly Diagnosed Extensive Stage Small Cell Lung Cancer,A Phase I/II Study of Bomedemstat Combined With Maintenance Immunotherapy for Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC),TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,University of Washington,,1.0,,Closed per SRC Low Accrual Policy,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,OTHER,,,,,,,2024,0.0
NCT01571635,,2012-04-03,2023-05-23,2015-12-11,2023-05-23,2012-04-04,2012-04-05,ESTIMATED,2023-05-23,2023-06-18,ACTUAL,2016-04-01,2016-05-02,ESTIMATED,2023-05-23,2023-06-18,ACTUAL,2012-10-10,ACTUAL,2012-10-10,2023-05,2023-05-31,2022-05-24,ACTUAL,2022-05-24,2015-07-02,ACTUAL,2015-07-02,,INTERVENTIONAL,,,Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With Beta( β)- Thalassemia.,"A Phase 2A, Open-label Dose Finding Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With BETA(b)-THALASSEMIA.",TERMINATED,,PHASE2,46.0,ACTUAL,Celgene,"Sotatercept development in β-thalassemia indication was stopped and no further patients were enrolled after 1 mg/kg cohort was completed. Due to the early termination of the study and no enrollment of the Expansion Cohort, the primary analyses to determine the recommended dose (RD) and the secondary analysis of QoL change from baseline were not conducted.",6.0,,Business objectives have changed,f,,,,f,,,,,,,,,,,,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,INDUSTRY,,,,,,,2022,0.0
NCT04001010,,2019-05-31,,,2021-02-02,2019-06-26,2019-06-27,ACTUAL,,,,,,,2021-02-02,2021-02-05,ACTUAL,2022-07,ESTIMATED,2022-07-31,2021-02,2021-02-28,2023-12,ESTIMATED,2023-12-31,2023-07,ESTIMATED,2023-07-31,,INTERVENTIONAL,SERENITY,,Safety and Efficacy of Inhaled Synthetic THC/CBD for Improving Physical Functioning and for Modulating Cachexia Progression in Patients With Advanced Cancer and Associated Cachexia,"Safety and Efficacy of PPP011-kit for Improving Physical Functioning and for Modulating Cachexia Progression in Patients With Advanced Cancer and Associated Cachexia: a Randomized, Double Blind, Placebo Controlled, Parallel Group Study",SUSPENDED,,PHASE3,334.0,ESTIMATED,Tetra Bio-Pharma,,2.0,,Study is postponed,f,,,,t,f,f,,,,,,,,,,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,INDUSTRY,,,,,,,2023,0.0
NCT03682692,,2018-09-18,,,2023-02-13,2018-09-20,2018-09-25,ACTUAL,,,,,,,2023-02-13,2023-02-14,ACTUAL,2018-06-01,ACTUAL,2018-06-01,2023-02,2023-02-28,2022-03-31,ACTUAL,2022-03-31,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,,,ACEI/CCB Versus ACEI/DIU Combination Antihypertensive Therapy in Chinese Hypertensive Patients (ACvAD),ACEI/CCB Versus ACEI/DIU Combination Antihypertensive Therapy in Chinese Hypertensive Patients (ACvAD),COMPLETED,,PHASE4,560.0,ACTUAL,Shanghai Jiao Tong University School of Medicine,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,OTHER,,,,,,,2022,1.0
NCT05316064,,2022-03-17,,,2024-05-08,2022-03-29,2022-04-07,ACTUAL,,,,,,,2024-05-08,2024-05-10,ACTUAL,2021-12-27,ACTUAL,2021-12-27,2024-05,2024-05-31,2023-11-28,ESTIMATED,2023-11-28,2023-11-28,ESTIMATED,2023-11-28,,INTERVENTIONAL,,,Reducing Abundance of Human Papilloma Virus in Women by Taking Probiotic,The Effects of Probiotic Against Reducing Abundance of Human Papilloma Virus (HPV) in Women,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Universiti Sains Malaysia,,2.0,,funding problem,f,,,,,f,f,,,,,,,,,NO,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,OTHER,,,,,,,2023,0.0
NCT04238390,,2019-12-16,,,2022-05-17,2020-01-19,2020-01-23,ACTUAL,,,,,,,2022-05-17,2022-05-19,ACTUAL,2022-01,ESTIMATED,2022-01-31,2021-10,2021-10-31,2024-12,ESTIMATED,2024-12-31,2024-06,ESTIMATED,2024-06-30,,INTERVENTIONAL,MERINO III,,Ceftolozane-tazobactam Versus Meropenem for ESBL and AmpC-producing Enterobacterales Bloodstream Infection,"A Multicentre, Parallel Group Open-label Randomised Controlled Non-Inferiority Phase 3 Trial, of Ceftolozane-tazobactam Versus Meropenem for Definitive Treatment of Bloodstream Infection Due to Extended-Spectrum Beta-Lactamase (ESBL) and AmpC-producing Enterobacterales",WITHDRAWN,,PHASE3,0.0,ACTUAL,The University of Queensland,,2.0,,The decision to withdraw the study was made due to delayed logistics of the supply chain of ceftolozane-tazobactam along with the immense complexities of conducting clinical research felt because of the COVID-19 pandemic.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,OTHER,,,,,,,2024,0.0
NCT03496207,,2018-03-29,2023-02-28,,2023-03-28,2018-04-11,2018-04-12,ACTUAL,2023-03-28,2023-04-19,ACTUAL,,,,2023-03-28,2023-04-19,ACTUAL,2018-06-13,ACTUAL,2018-06-13,2023-03,2023-03-31,2022-03-09,ACTUAL,2022-03-09,2022-03-09,ACTUAL,2022-03-09,,INTERVENTIONAL,PULSAR,,A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH),"A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)",COMPLETED,,PHASE2,106.0,ACTUAL,"Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA",,3.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,INDUSTRY,,,,,,,2022,1.0
NCT05107856,,2021-10-25,,,2024-01-29,2021-10-25,2021-11-04,ACTUAL,,,,,,,2024-01-29,2024-01-31,ACTUAL,2022-03-22,ACTUAL,2022-03-22,2024-01,2024-01-31,2024-01-19,ACTUAL,2024-01-19,2024-01-19,ACTUAL,2024-01-19,,INTERVENTIONAL,,,PRT1419 as Monotherapy or in Combination With Azacitidine or Venetoclax in R/R Myeloid or B-cell Malignancies,"A Phase 1, Open-Label, Multicenter, Dose Escalation Study of PRT1419 Injection as Monotherapy or in Combination With Azacitidine or Venetoclax in Patients With Relapsed/Refractory Myeloid or B-cell Malignancies",TERMINATED,,PHASE1,21.0,ACTUAL,Prelude Therapeutics,,3.0,,Company Decision,f,,,,f,t,f,,,,,,,,,,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,INDUSTRY,,,,,,,2024,0.0
NCT03591965,,2018-06-20,,,2023-07-06,2018-07-17,2018-07-19,ACTUAL,,,,,,,2023-07-06,2023-07-10,ACTUAL,2018-08-07,ACTUAL,2018-08-07,2023-01,2023-01-31,2022-08-03,ACTUAL,2022-08-03,2022-08-03,ACTUAL,2022-08-03,,INTERVENTIONAL,,,Dual TORC1/TORC2 Inhibitor ATG-008 (CC-223) in HBV Positive Advanced Hepatocellular Carcinoma (HCC) Subjects,An Open-label Phase 2 Trial of Dual TORC1/TORC2 Inhibitor ATG-008 in HBV+ Advanced Hepatocellular Carcinoma (HCC) Subjects Who Have Received at Least One Prior Line of Systemic Therapy (TORCH),TERMINATED,,PHASE2,73.0,ACTUAL,Antengene Corporation,,1.0,,Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,INDUSTRY,,,,,,,2022,0.0
NCT03631732,,2018-08-13,2020-08-12,,2021-08-09,2018-08-13,2018-08-15,ACTUAL,2020-08-12,2020-08-27,ACTUAL,,,,2021-08-09,2021-09-05,ACTUAL,2018-08-28,ACTUAL,2018-08-28,2021-08,2021-08-31,2020-08-19,ACTUAL,2020-08-19,2019-08-12,ACTUAL,2019-08-12,,INTERVENTIONAL,BRAAVE 2020,The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1).,"Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants","A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants",COMPLETED,,PHASE3,496.0,ACTUAL,Gilead Sciences,,2.0,,,f,,,,f,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.",2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,INDUSTRY,,,,,,,2020,1.0
NCT03909165,,2019-04-08,2024-08-13,,2024-09-20,2019-04-08,2019-04-09,ACTUAL,2024-09-20,2024-09-26,ACTUAL,,,,2024-09-20,2024-09-26,ACTUAL,2019-07-23,ACTUAL,2019-07-23,2024-09,2024-09-30,2023-09-21,ACTUAL,2023-09-21,2023-09-21,ACTUAL,2023-09-21,,INTERVENTIONAL,,"The population used for Baseline Characteristics was the All Participants Allocated (Part A)/Randomized (Part B) Population, with the exception of the Protocol-defined Age Cohorts characteristic and Type of Neuromuscular Blocking Agent (NMBA) Characteristic, which were reported per protocol for the All Participants as Treated (APaT) population.","Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)","A Phase 4 Double-blinded, Randomized, Active Comparator-controlled Clinical Trial to Study the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years",COMPLETED,,PHASE4,145.0,ACTUAL,Merck Sharp & Dohme LLC,,5.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,INDUSTRY,,,,,,,2023,1.0
NCT05039944,,2021-08-22,,,2024-07-16,2021-09-07,2021-09-10,ACTUAL,,,,,,,2024-07-16,2024-07-18,ACTUAL,2021-11-30,ACTUAL,2021-11-30,2024-07,2024-07-31,2022-06-06,ACTUAL,2022-06-06,2022-06-06,ACTUAL,2022-06-06,,INTERVENTIONAL,,,SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Digestive System Malignancies,A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Unresectable or Metastatic Digestive System Malignancies (Colorectal and Gastric Cancer),TERMINATED,,PHASE2,7.0,ACTUAL,"Sichuan Baili Pharmaceutical Co., Ltd.",,6.0,,Company research strategy adjustment,f,,,,,f,f,,,,,,,,,,,2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,INDUSTRY,,,,,,,2022,0.0
NCT02700048,,2016-02-24,2023-02-24,,2023-03-24,2016-03-01,2016-03-07,ESTIMATED,2023-03-24,2023-03-27,ACTUAL,,,,2023-03-24,2023-03-27,ACTUAL,2016-06,ACTUAL,2016-06-30,2023-03,2023-03-31,2021-07,ACTUAL,2021-07-31,2021-07,ACTUAL,2021-07-31,,INTERVENTIONAL,,the device failed so data was not collected and participants dropped prior to collecting baseline data,Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia,Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia,TERMINATED,,PHASE1/PHASE2,11.0,ACTUAL,University of Minnesota,,2.0,,research grant for the trial was not funded,f,,,,t,t,f,,,,,,,,,,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,OTHER,,,,,,,2021,0.0
NCT03082729,,2017-02-22,2022-08-19,,2022-10-14,2017-03-10,2017-03-17,ACTUAL,2022-10-14,2022-11-10,ACTUAL,,,,2022-10-14,2022-11-10,ACTUAL,2017-04-24,ACTUAL,2017-04-24,2022-10,2022-10-31,2021-08-17,ACTUAL,2021-08-17,2021-08-17,ACTUAL,2021-08-17,,INTERVENTIONAL,VIP-A,,Vascular Inflammation in Psoriasis - Apremilast,"A Phase IV, Open Label Study of the Effects of Apremilast on Vascular Inflammation and Cardiometabolic Function in Psoriasis",COMPLETED,,PHASE4,70.0,ACTUAL,University of Pennsylvania,The lack of placebo control; The number of biomarkers assessed may result in alpha error given the large number of pathways interrogated and thus the cardiometabolic biomarkers may be considered exploratory; Only surrogate markers evaluated and not actual clinical events.,1.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,OTHER,,,,,,,2021,1.0
NCT04249687,,2020-01-07,2023-05-23,2021-05-26,2023-05-23,2020-01-29,2020-01-31,ACTUAL,2023-05-23,2023-06-18,ACTUAL,2021-05-26,2021-05-28,ACTUAL,2023-05-23,2023-06-18,ACTUAL,2020-02-10,ACTUAL,2020-02-10,2021-03,2021-03-31,2021-02-10,ACTUAL,2021-02-10,2020-09-25,ACTUAL,2020-09-25,,INTERVENTIONAL,READY-2,,Treatment of Moderate to Severe Lateral Canthal Lines,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Lateral Canthal Lines",COMPLETED,,PHASE3,303.0,ACTUAL,Galderma R&D,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,INDUSTRY,,,,,,,2021,1.0
NCT02352753,,2015-01-28,2022-09-26,,2022-11-28,2015-01-28,2015-02-02,ESTIMATED,2022-11-28,2022-12-28,ACTUAL,,,,2022-11-28,2022-12-28,ACTUAL,2015-06-24,ACTUAL,2015-06-24,2022-11,2022-11-30,2022-03-26,ACTUAL,2022-03-26,2022-03-26,ACTUAL,2022-03-26,,INTERVENTIONAL,OI,The full analysis set (FAS) included all participants who enrolled into the study.,"Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI","To Evaluate the Effect of Denosumab in Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, as Assessed by Dual-energy X-ray Absorptiometry (DXA), in Children 2 to 17 Years of Age (at the Time of Screening) on a 3-Month Dosing Regimen With OI",TERMINATED,,PHASE3,153.0,ACTUAL,Amgen,,1.0,,The study was stopped earlier than planned due to safety concerns about high levels of calcium in the blood of the participants,f,,,,t,,,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,INDUSTRY,,,,,,,2022,0.0
NCT04264208,,2020-02-04,2023-11-07,,2024-01-09,2020-02-07,2020-02-11,ACTUAL,2024-01-09,2024-02-01,ACTUAL,,,,2024-01-09,2024-02-01,ACTUAL,2020-02-05,ACTUAL,2020-02-05,2024-01,2024-01-31,2022-12-14,ACTUAL,2022-12-14,2022-11-22,ACTUAL,2022-11-22,,INTERVENTIONAL,,,"HDR Brachytherapy 68-Ga-RM2 PET, 68-Ga-PSMA-11 PET &Multi Parametric MRI in Prostate Cancer","Evaluation of Patients With Low-Risk and Intermediate-Risk Prostate Cancer Scheduled for High-Dose Rate Brachytherapy Using 68-Ga-RM2 PET, 68Ga-PSMA-11 PET and Multi Parametric MRI",TERMINATED,,PHASE2,4.0,ACTUAL,Stanford University,Early termination led to a small number of subjects analyzed,2.0,,Lack of accrual due to pandemic and logistics,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,OTHER,,,,,,,2022,0.0
NCT03828929,,2019-01-29,,,2020-02-06,2019-01-31,2019-02-04,ACTUAL,,,,,,,2020-02-06,2020-02-10,ACTUAL,2019-10-15,ACTUAL,2019-10-15,2020-02,2020-02-29,2020-02-04,ACTUAL,2020-02-04,2020-01-28,ACTUAL,2020-01-28,,INTERVENTIONAL,,,"Effect of IV Vitamin C, Thiamine, and Steroids on Mortality of Septic Shock","Effect of IV Vitamin C, Thiamine, and Steroids on Mortality of Septic Shock",TERMINATED,,PHASE3,3.0,ACTUAL,New York Presbyterian Brooklyn Methodist Hospital,,2.0,,Recent similar studies have been completed and published showing no benefit to the intervention.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,OTHER,,,,,,,2020,0.0
NCT03259074,,2017-08-21,2022-11-21,2022-07-08,2023-08-16,2017-08-21,2017-08-23,ACTUAL,2023-02-10,2023-03-09,ACTUAL,2023-02-10,2023-03-09,ACTUAL,2023-08-16,2023-08-21,ACTUAL,2017-11-30,ACTUAL,2017-11-30,2023-08,2023-08-31,2021-11-29,ACTUAL,2021-11-29,2021-11-12,ACTUAL,2021-11-12,,INTERVENTIONAL,SURPASS,,Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar),"A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis",COMPLETED,,PHASE3,859.0,ACTUAL,Novartis,,3.0,,,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,INDUSTRY,,,,,,,2021,1.0
NCT03775421,,2018-11-21,2023-01-16,,2023-03-06,2018-12-11,2018-12-14,ACTUAL,2023-03-06,2023-03-07,ACTUAL,,,,2023-03-06,2023-03-07,ACTUAL,2019-04-11,ACTUAL,2019-04-11,2023-03,2023-03-31,2022-01-18,ACTUAL,2022-01-18,2022-01-18,ACTUAL,2022-01-18,,INTERVENTIONAL,RUBATO OL,,An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.,"Prospective, Multi-center, Single-arm, Open-label Long-term Study Assessing the Safety, Tolerability, and Effectiveness of Macitentan in Fontan-palliated Adult and Adolescent Subjects",TERMINATED,,PHASE3,112.0,ACTUAL,Actelion,The study was stopped prematurely by the sponsor because the main double-blind (DB) study (AC-055H301; NCT03153137) did not meet the primary and secondary efficacy outcome measures.,1.0,,"As The RUBATO DB study (NCT03153137) did not show any benefit of treatment with macitentan in Fontan-palliated participants, the sponsor has decided to terminate the RUBATO OL study (NCT03775421). No new safety observations were made.",f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials\\transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu",2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,INDUSTRY,,,,,,,2022,0.0
NCT03432533,,2018-01-30,2020-03-24,,2020-11-05,2018-02-12,2018-02-14,ACTUAL,2020-04-09,2020-04-10,ACTUAL,,,,2020-11-05,2020-11-23,ACTUAL,2018-02-06,ACTUAL,2018-02-06,2020-10,2020-10-31,2020-01-08,ACTUAL,2020-01-08,2019-04-11,ACTUAL,2019-04-11,,INTERVENTIONAL,,,A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis,"A Randomized, Multicenter, Open-label, Parallel Group Study in Postmenopausal Women With Osteoporosis to Evaluate the Noninferiority of Subject-administered Romosozumab Via Autoinjector/Pen vs Healthcare Provider-administered Romosozumab Via Prefilled Syringe",COMPLETED,,PHASE3,283.0,ACTUAL,Amgen,,2.0,,,f,,,,f,t,t,t,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,INDUSTRY,,,,,,,2020,1.0
NCT04795141,,2021-03-03,,2023-06-27,2023-07-06,2021-03-10,2021-03-12,ACTUAL,,,,,2023-07-06,ACTUAL,2023-07-06,2023-07-12,ACTUAL,2021-08-24,ACTUAL,2021-08-24,2023-07,2023-07-31,2022-08-30,ACTUAL,2022-08-30,2022-07-11,ACTUAL,2022-07-11,,INTERVENTIONAL,,,ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis",TERMINATED,,PHASE2,25.0,ACTUAL,Inmagene LLC,,7.0,,The sponsor's development strategy is adjusted.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,INDUSTRY,,,,,,,2022,0.0
NCT03523767,,2018-05-01,,,2023-03-31,2018-05-01,2018-05-14,ACTUAL,,,,,,,2023-03-31,2023-04-04,ACTUAL,2018-02-07,ACTUAL,2018-02-07,2023-03,2023-03-31,2020-02-07,ACTUAL,2020-02-07,2020-02-07,ACTUAL,2020-02-07,,INTERVENTIONAL,,,Effect of Systemic Inflammation on Emotion and Cognition in Patients With Mood Disorder - A Vaccine Study,Effect of Systemic Inflammation on Emotion and Cognition in Patients With Mood Disorder - A Vaccine Study,TERMINATED,,PHASE1,19.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,Early termination related to COVID pandemic,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,OTHER,,,,,,,2020,0.0
NCT01959139,,2013-09-30,2019-12-06,,2024-02-07,2013-10-07,2013-10-09,ESTIMATED,2020-01-31,2020-02-12,ACTUAL,,,,2024-02-07,2024-02-09,ACTUAL,2014-01-23,ACTUAL,2014-01-23,2024-02,2024-02-29,2023-11-09,ACTUAL,2023-11-09,2019-04,ACTUAL,2019-04-30,,INTERVENTIONAL,,,"S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer","S1313, A Phase IB/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) Versus Modified FOLFIRINOX Alone in Patients With Good Performance Status Metastatic Pancreatic Adenocarcinoma",COMPLETED,,PHASE1/PHASE2,126.0,ACTUAL,SWOG Cancer Research Network,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,NETWORK,,,,,,,2023,1.0
NCT05011513,,2021-07-30,2023-07-20,,2023-07-20,2021-08-16,2021-08-18,ACTUAL,2023-07-20,2023-08-14,ACTUAL,,,,2023-07-20,2023-08-14,ACTUAL,2021-08-25,ACTUAL,2021-08-25,2023-07,2023-07-31,2022-07-25,ACTUAL,2022-07-25,2022-07-25,ACTUAL,2022-07-25,,INTERVENTIONAL,,Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received. A randomized but not treated participant was excluded from the safety analyses.,Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).,"AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2 ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF 07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT LOW RISK OF PROGRESSING TO SEVERE ILLNESS",TERMINATED,,PHASE2/PHASE3,1440.0,ACTUAL,Pfizer,"In participant flow, there was discontinuations due to AE, which was captured under Death as reason for discontinuation. Adverse event was COVID-19 pneumonia and the participant died due to that event and discontinued study.",2.0,,Enrollment ceased due to a very low rate of hospitalization or death observed in the standard-risk patient population,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,INDUSTRY,,,,,,,2022,0.0
NCT06021119,,2023-08-26,,,2023-08-26,2023-08-26,2023-09-01,ACTUAL,,,,,,,2023-08-26,2023-09-01,ACTUAL,2023-03-23,ACTUAL,2023-03-23,2023-08,2023-08-31,2023-04-21,ACTUAL,2023-04-21,2023-04-21,ACTUAL,2023-04-21,,INTERVENTIONAL,,,Feasibility of DPP-4 Inhibitor Therapy on Advanced Hybrid Closed Loop System,Feasibility of DPP-4 Inhibitor for the Treatment of Iftar-Related Glycemic Excursions in Patients With Type 1 Diabetes on MiniMed™ 780G Advanced Hybrid Closed Loop System,COMPLETED,,PHASE3,50.0,ACTUAL,Ain Shams University,,2.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,OTHER,,,,,,,2023,1.0
NCT05029856,,2021-08-25,,,2022-05-25,2021-08-25,2021-09-01,ACTUAL,,,,,,,2022-05-25,2022-05-31,ACTUAL,2022-02-04,ESTIMATED,2022-02-04,2022-05,2022-05-31,2022-08,ESTIMATED,2022-08-31,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,,,Evaluation of the Safety and Immunogenicity of SII Vaccine Constructs Based on the SARS-CoV-2 (COVID-19) Variant in Adults,"A Randomized, Observer-Blinded, Phase 1/2 Study With an Open-Label Group to Evaluate the Safety and Immunogenicity of SII Vaccine Constructs Based on SARS-CoV-2 Variants in Adults",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Novavax,,8.0,,Study never started,f,,,,f,f,f,,,,,,,,,,,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,INDUSTRY,,,,,,,2022,0.0
NCT03788291,,2018-12-24,2024-06-21,,2024-09-16,2018-12-24,2018-12-27,ACTUAL,2024-09-16,2024-09-26,ACTUAL,,,,2024-09-16,2024-09-26,ACTUAL,2019-03-25,ACTUAL,2019-03-25,2024-09,2024-09-30,2023-05-19,ACTUAL,2023-05-19,2023-05-19,ACTUAL,2023-05-19,,INTERVENTIONAL,,,Acalabrutinib and High Frequency Low Dose Subcutaneous Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma,Phase II Study of Acalabrutinib and High Frequency Low Dose Subcutaneous Rituximab in Patients With Previously Untreated CLL/SLL,COMPLETED,,PHASE2,39.0,ACTUAL,University of Rochester,,1.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,OTHER,,,,,,,2023,1.0
NCT03750773,,2018-11-16,,,2020-07-27,2018-11-20,2018-11-23,ACTUAL,,,,,,,2020-07-27,2020-07-29,ACTUAL,2019-07-02,ESTIMATED,2019-07-02,2020-07,2020-07-31,2020-04,ESTIMATED,2020-04-30,2020-03,ESTIMATED,2020-03-31,,INTERVENTIONAL,GRIPP,,Gabapentin for Relief of Immediate Postoperative Pain,GRIPP: Gabapentin for Relief of Immediate Postoperative Pain,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Indiana University,,2.0,,Lack of funding,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,OTHER,,,,,,,2020,0.0
NCT04411082,,2020-04-15,2022-06-06,,2023-03-06,2020-05-27,2020-06-02,ACTUAL,2022-06-06,2022-06-30,ACTUAL,,,,2023-03-06,2023-03-08,ACTUAL,2020-10-16,ACTUAL,2020-10-16,2022-06,2022-06-30,2022-05-04,ACTUAL,2022-05-04,2022-03-11,ACTUAL,2022-03-11,,INTERVENTIONAL,,Safety Analysis Set,A Study of IMR-687 in Subjects With Beta Thalassemia,A Phase 2 Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects With Beta Thalassemia,TERMINATED,,PHASE2,122.0,ACTUAL,"Imara, Inc.",,3.0,,"IMR-BTL-201demonstrated that while IMR-687 was generally well-tolerated, it failed to show any meaningful benefit in transfusion burden or improvement in most disease-related biomarkers. So, the sponsor has decided to discontinue this study",,,,,t,t,f,,,,,,,,,,,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,INDUSTRY,,,,,,,2022,0.0
NCT03089619,,2017-02-27,,,2023-07-13,2017-03-17,2017-03-24,ACTUAL,,,,,,,2023-07-13,2023-07-17,ACTUAL,2016-05-02,ACTUAL,2016-05-02,2023-07,2023-07-31,2023-05-08,ACTUAL,2023-05-08,2022-01-14,ACTUAL,2022-01-14,,INTERVENTIONAL,,,Alveolar Management Following Teeth Extraction,A Method for Measuring Volume Changes of the Alveolar Ridge During Dental Implantation Using 3D Scanning,TERMINATED,,PHASE4,21.0,ACTUAL,University Medicine Greifswald,,2.0,,"Difficulties in recruiting of suitable patients, bad compliance of patients",f,,,,t,f,f,,,,,,,,,NO,IPD will not be shared in accordance with medical data protection regulations.,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,OTHER,,,,,,,2023,0.0
NCT02855268,,2016-07-28,2023-09-08,,2023-10-19,2016-08-01,2016-08-04,ESTIMATED,2023-10-19,2023-10-23,ACTUAL,,,,2023-10-19,2023-10-23,ACTUAL,2019-11-02,ACTUAL,2019-11-02,2023-10,2023-10-31,2022-09-22,ACTUAL,2022-09-22,2022-09-22,ACTUAL,2022-09-22,,INTERVENTIONAL,HERA,Analysis was performed on all randomized population.,Study of Lademirsen (SAR339375) in Patients With Alport Syndrome,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of Lademirsen (SAR339375) for Subcutaneous Injection Administered Every Week in Patients With Alport Syndrome",TERMINATED,,PHASE2,43.0,ACTUAL,Sanofi,"Due to early study termination, Stage 2/Cohort 2 was not conducted. In Stage 1 analysis of DB period was performed until 48 weeks. In Stage 1 OL period, only safety data was collected and assessed.",2.0,,The results of the futility analysis led to the study termination. No unexpected safety findings were identified.,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,INDUSTRY,,,,,,,2022,0.0
NCT04697485,,2020-12-07,,,2022-05-04,2021-01-05,2021-01-06,ACTUAL,,,,,,,2022-05-04,2022-05-10,ACTUAL,2021-01-08,ACTUAL,2021-01-08,2022-05,2022-05-31,2022-03-30,ESTIMATED,2022-03-30,2022-01-01,ACTUAL,2022-01-01,,INTERVENTIONAL,,,Polydiuretic Therapy for Heart Failure With Preserved Ejection Fraction and Diabetes Mellitus,Polydiuretic Therapy for Heart Failure With Preserved Ejection Fraction and Diabetes Mellitus: A Pilot Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,Northwestern University,,1.0,,Enrollment and funding challenges,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,OTHER,,,,,,,2022,0.0
NCT03505021,,2018-04-16,2021-07-01,,2022-04-22,2018-04-16,2018-04-20,ACTUAL,2021-08-04,2021-08-31,ACTUAL,,,,2022-04-22,2022-05-11,ACTUAL,2018-06-21,ACTUAL,2018-06-21,2022-04,2022-04-30,2020-07-23,ACTUAL,2020-07-23,2020-07-23,ACTUAL,2020-07-23,,INTERVENTIONAL,REFALS,"Intention-to-treat (ITT) dataset, including all randomised subjects, was used for the primary evaluation. Sensitivity analyses using full analysis set (FAS) and two per-protocol (PP) datasets (up to 12 weeks and up to 48 weeks) were performed. FAS included all treated subjects with at least one post baseline SVC measurement. PP dataset included all randomised subjects except subjects with relevant major protocol deviations.",Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS,Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS,COMPLETED,,PHASE3,496.0,ACTUAL,"Orion Corporation, Orion Pharma",,2.0,,,,,,,t,t,f,,,,,,,,,,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,INDUSTRY,,,,,,,2020,1.0
NCT03319823,,2017-10-10,,,2021-02-02,2017-10-19,2017-10-24,ACTUAL,,,,,,,2021-02-02,2021-02-04,ACTUAL,2017-10-25,ACTUAL,2017-10-25,2021-02,2021-02-28,2021-02-01,ACTUAL,2021-02-01,2019-02-13,ACTUAL,2019-02-13,,INTERVENTIONAL,,,Treating Nocturnal Hypertension and Nocturia in African American Men,A Pilot Study: Treating Nocturnal Hypertension and Nocturia in African American Men,WITHDRAWN,,PHASE4,0.0,ACTUAL,Cedars-Sinai Medical Center,,2.0,,"Due to the Pandemic, we decided to end this study.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,OTHER,,,,,,,2021,0.0
NCT01036087,,2009-12-17,2022-07-14,,2023-03-29,2009-12-17,2009-12-21,ESTIMATED,2022-08-25,2022-09-21,ACTUAL,,,,2023-03-29,2023-03-30,ACTUAL,2010-11,ACTUAL,2010-11-30,2023-03,2023-03-31,2022-08-09,ACTUAL,2022-08-09,2016-02-11,ACTUAL,2016-02-11,,INTERVENTIONAL,,,"Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer","Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression",COMPLETED,,PHASE2,47.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 16:24:34.346726,2024-10-15 16:24:34.346726,OTHER,,,,,,,2022,1.0
NCT03718429,,2018-10-19,2021-09-14,,2022-05-31,2018-10-23,2018-10-24,ACTUAL,2022-05-31,2022-06-27,ACTUAL,,,,2022-05-31,2022-06-27,ACTUAL,2019-01-14,ACTUAL,2019-01-14,2022-05,2022-05-31,2020-08-30,ACTUAL,2020-08-30,2020-02-13,ACTUAL,2020-02-13,,INTERVENTIONAL,,Baseline characteristics are provided for each one of the initial 4 treatment cohorts. These already includes patients in other treatment arms were rivaroxaban 2.5 mg was added and aspirin stopped in each patient of each cohort.,Pharmacodynamic Effects of Low-dose Rivaroxaban With Antiplatelet Therapies,Pharmacodynamic Effects of Low-dose Rivaroxaban in Combination With Antiplatelet Therapies in Patients With Coronary and Peripheral Artery Disease Manifestations,COMPLETED,,PHASE4,86.0,ACTUAL,University of Florida,,4.0,,,f,,,,,t,f,,,f,,,,,,NO,No sharing is planned,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,OTHER,,,,,,,2020,1.0
NCT03972215,,2019-05-29,,,2023-07-07,2019-05-30,2019-06-03,ACTUAL,,,,,,,2023-07-07,2023-07-10,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2023-07,2023-07-31,2020-02-17,ACTUAL,2020-02-17,2020-01-20,ACTUAL,2020-01-20,,INTERVENTIONAL,BBR HC,,Berberine Hyperglycemic Clamp,Effect of Berberine on Insulin Release at a High Blood Glucose Level in Normal Man,COMPLETED,,EARLY_PHASE1,15.0,ACTUAL,Beijing Tongren Hospital,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,OTHER,,,,,,,2020,1.0
NCT04296942,,2020-03-04,2021-12-09,,2021-12-09,2020-03-04,2020-03-05,ACTUAL,2021-12-09,2022-01-11,ACTUAL,,,,2021-12-09,2022-01-11,ACTUAL,2021-05-04,ACTUAL,2021-05-04,2021-12,2021-12-31,2021-10-22,ACTUAL,2021-10-22,2021-10-22,ACTUAL,2021-10-22,,INTERVENTIONAL,,No participants were enrolled in group 2 and 3 due to study closure by the sponsor.,"BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)","A Phase 1b Trial of Sequential Combinations of BN-Brachyury, Entinostat, Ado-trastuzuamb Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)",TERMINATED,,PHASE1,1.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,"One participant was accrued, and the study was stopped due to new safety data from the company for M7824 and slow accrual.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,NIH,,,,,,,2021,0.0
NCT05576662,,2022-10-10,2024-08-14,,2024-09-19,2022-10-10,2022-10-12,ACTUAL,2024-09-19,2024-09-25,ACTUAL,,,,2024-09-19,2024-09-25,ACTUAL,2022-11-08,ACTUAL,2022-11-08,2024-09,2024-09-30,2023-09-12,ACTUAL,2023-09-12,2023-08-14,ACTUAL,2023-08-14,,INTERVENTIONAL,STOP-PASC,,Paxlovid for Treatment of Long Covid,Selective Trial Of Paxlovid for PASC (STOP-PASC): Randomized Double-Blind Placebo-Controlled Pilot Trial of Paxlovid for the Treatment of PASC,COMPLETED,,PHASE2,168.0,ACTUAL,Stanford University,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,"Currently, there is no plan for data sharing.",2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,OTHER,,,,,,,2023,1.0
NCT04607252,,2020-10-23,,,2024-09-24,2020-10-28,2020-10-29,ACTUAL,,,,,,,2024-09-24,2024-09-26,ACTUAL,2021-01-11,ACTUAL,2021-01-11,2024-09,2024-09-30,2021-06-03,ACTUAL,2021-06-03,2021-06-03,ACTUAL,2021-06-03,,INTERVENTIONAL,,,Metformin Plus Megestrol Acetate As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia,Comparing Metformin Plus Megestrol Acetate with Megestrol Acetate Alone As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia,TERMINATED,,PHASE2/PHASE3,12.0,ACTUAL,Fudan University,,2.0,,"Our clinical trial NCT03241888 showed LNG-IUS had a better treatment efficacy than Megestrol Acetate (MA) alone. The median CR time for MA group, LNG-IUS group and MA plus LNG-IUS group was 7.0±0.3 months, 4.4±1.0 months and 5.7±1.2 months.",f,,,,f,f,f,,,f,,,,,,NO,Data will be shared with other researchers without patients' personal information after all the findings being published.,2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,OTHER,,,,,,,2021,0.0
NCT04085601,,2019-09-09,2022-08-18,,2022-10-14,2019-09-09,2019-09-11,ACTUAL,2022-10-14,2022-10-21,ACTUAL,,,,2022-10-14,2022-10-21,ACTUAL,2019-08-27,ACTUAL,2019-08-27,2022-10,2022-10-31,2021-06-23,ACTUAL,2021-06-23,2021-06-23,ACTUAL,2021-06-23,,INTERVENTIONAL,,The intent-to-treat (ITT) set included all subjects assigned to treatment.,A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With PNH,"A Phase 3, Randomized, Multicenter, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)",COMPLETED,,PHASE3,53.0,ACTUAL,"Apellis Pharmaceuticals, Inc.",,2.0,,,,,,,t,t,f,,,,,,,,,,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,INDUSTRY,,,,,,,2021,1.0
NCT05728736,,2023-02-05,,,2023-11-03,2023-02-05,2023-02-15,ACTUAL,,,,,,,2023-11-03,2023-11-08,ACTUAL,2023-03-01,ACTUAL,2023-03-01,2023-11,2023-11-30,2023-10-04,ACTUAL,2023-10-04,2023-09-27,ACTUAL,2023-09-27,,INTERVENTIONAL,,,Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau,Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau,WITHDRAWN,,PHASE2,0.0,ACTUAL,Washington University School of Medicine,,2.0,,"Study was terminated due to enrollment difficulties and the inability to obtain necessary study supplies. Five participants signed consent; however, no one was randomized. The study was officially terminated with the funding source on 10/04/2023.",f,,,,t,t,f,,,,,,,,,,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,OTHER,,,,,,,2023,0.0
NCT04314856,,2020-03-11,,,2022-11-10,2020-03-17,2020-03-19,ACTUAL,,,,,,,2022-11-10,2022-11-15,ACTUAL,2021-01-12,ACTUAL,2021-01-12,2022-11,2022-11-30,2022-06,ESTIMATED,2022-06-30,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,Novel Clinical Target in Fragile X Syndrome,Sigma-1 Receptors: A Novel Clinical Target in Fragile X Syndrome,WITHDRAWN,,PHASE1,0.0,ACTUAL,Stanford University,,2.0,,Principal investigator left institution,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,OTHER,,,,,,,2022,0.0
NCT06438354,,2024-05-27,,,2024-05-27,2024-05-27,2024-05-31,ACTUAL,,,,,,,2024-05-27,2024-05-31,ACTUAL,2022-08-01,ACTUAL,2022-08-01,2024-05,2024-05-31,2024-02-29,ACTUAL,2024-02-29,2023-10-30,ACTUAL,2023-10-30,,INTERVENTIONAL,,,Non-surgical Step 3 Periodontal Treatment With/Without Adjunctive Protocol - Pilot RCT.,Non-surgical Treatment of Residual Periodontal Pockets Using Sodium Hypochlorite/Amino Acid Gel and Cross-linked Hyaluronic Acid - a 9-month Randomized Controlled Clinical Trial.,COMPLETED,,PHASE4,52.0,ACTUAL,University of Witten/Herdecke,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,OTHER,,,,,,,2024,1.0
NCT04034004,,2019-05-09,2023-02-09,,2023-10-04,2019-07-25,2019-07-26,ACTUAL,2023-08-02,2023-08-04,ACTUAL,,,,2023-10-04,2023-10-11,ACTUAL,2021-01-01,ACTUAL,2021-01-01,2023-10,2023-10-31,2022-12-22,ACTUAL,2022-12-22,2022-12-22,ACTUAL,2022-12-22,,INTERVENTIONAL,,The analysis population was not different from the assignment in participant flow.,Chronic Low Back Pain and Meditation,The Role of Endogenous Opioids in Mindfulness-based Chronic Pain Relief,COMPLETED,,EARLY_PHASE1,88.0,ACTUAL,"University of California, San Diego",The most significant limitation was performing highly invasive pain and pharmacologic testing during the coronavirus pandemic.,2.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,OTHER,,,,,,,2022,1.0
NCT04508621,,2020-08-07,2022-11-07,,2023-12-13,2020-08-07,2020-08-11,ACTUAL,2022-11-07,2022-12-02,ACTUAL,,,,2023-12-13,2023-12-18,ACTUAL,2020-07-22,ACTUAL,2020-07-22,2023-12,2023-12-31,2021-11-01,ACTUAL,2021-11-01,2021-11-01,ACTUAL,2021-11-01,,INTERVENTIONAL,RALLY,,A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia,"A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia",COMPLETED,,PHASE3,514.0,ACTUAL,"Tonix Pharmaceuticals, Inc.",Recruitment during COVID-19 pandemic,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,INDUSTRY,,,,,,,2021,1.0
NCT03536559,,2018-05-02,,,2023-03-30,2018-05-14,2018-05-24,ACTUAL,,,,,,,2023-03-30,2023-04-03,ACTUAL,2018-11-23,ACTUAL,2018-11-23,2023-03,2023-03-31,2022-07-12,ACTUAL,2022-07-12,2022-04-27,ACTUAL,2022-04-27,,INTERVENTIONAL,VISIONARY-MS,,Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis,"A Phase 2, Randomized, DB-PC, Parallel Group Study for the Treatment of Visual Pathway Deficits In Chronic Optic Neuropathy to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of CNM-Au8 For Remyelination In Multiple Sclerosis",TERMINATED,,PHASE2,73.0,ACTUAL,Clene Nanomedicine,,3.0,,COVID-19 related enrollment challenges.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,INDUSTRY,,,,,,,2022,0.0
NCT04147234,,2019-10-30,,,2024-04-29,2019-10-30,2019-11-01,ACTUAL,,,,,,,2024-04-29,2024-04-30,ACTUAL,2020-03-09,ACTUAL,2020-03-09,2024-04,2024-04-30,2024-03-21,ACTUAL,2024-03-21,2022-11-15,ACTUAL,2022-11-15,,INTERVENTIONAL,,,A Study to Find the Best Dose of BI 1387446 Alone or in Combination With Ezabenlimab (BI 754091) in Patients With Different Types of Advanced or Metastatic Cancer (Solid Tumors),"Phase I, First in Human Trial Evaluating BI 1387446 Alone and in Combination With Ezabenlimab (BI 754091) in Solid Tumors",COMPLETED,,PHASE1,39.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,f,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.",2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,INDUSTRY,,,,,,,2024,0.0
NCT03426345,,2018-02-02,2021-07-15,,2021-07-15,2018-02-02,2018-02-08,ACTUAL,2021-07-15,2021-08-06,ACTUAL,,,,2021-07-15,2021-08-06,ACTUAL,2018-02-16,ACTUAL,2018-02-16,2021-07,2021-07-31,2020-07-16,ACTUAL,2020-07-16,2020-07-16,ACTUAL,2020-07-16,,INTERVENTIONAL,,Intent-to-treat (ITT) Population included all randomized participants.,Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02,"A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis",TERMINATED,,PHASE3,311.0,ACTUAL,Allergan,,2.0,,The Relamorelin program is being terminated solely based on a business decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,INDUSTRY,,,,,,,2020,0.0
NCT03044314,,2016-10-06,2022-10-31,2022-01-21,2024-03-06,2017-02-02,2017-02-07,ESTIMATED,2024-03-06,2024-04-02,ACTUAL,,2024-04-02,ACTUAL,2024-03-06,2024-04-02,ACTUAL,2017-07-21,ACTUAL,2017-07-21,2024-03,2024-03-31,2020-05-19,ACTUAL,2020-05-19,2019-06-20,ACTUAL,2019-06-20,,INTERVENTIONAL,OVATION,Participants who completed the study.,Outpatient Vasodilator Assessment Using Iloprost in Pulmonary Hypertension,Outpatient Vasodilator Assessment Using Iloprost in Pulmonary Hypertension (The OVATION Study),TERMINATED,,PHASE4,27.0,ACTUAL,Duke University,,1.0,,slow enrollment,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,OTHER,,,,,,,2020,0.0
NCT02302508,,2014-11-11,,,2019-07-22,2014-11-24,2014-11-27,ESTIMATED,,,,,,,2019-07-22,2019-07-24,ACTUAL,2019-09-01,ESTIMATED,2019-09-01,2017-08,2017-08-31,2021-12,ESTIMATED,2021-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,PANDDA,,Pharmacokinetics of Antiplatelet Drugs in Diabetic pAtients,PANDDA Study: Pharmacokinetics of Antiplatelet Drugs in Diabetic pAtients,WITHDRAWN,,PHASE4,0.0,ACTUAL,Centre hospitalier de l'Université de Montréal (CHUM),,4.0,,Funding,f,,,,t,f,f,,,,,,,,,,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,OTHER,,,,,,,2021,0.0
NCT01998035,,2013-11-20,2023-03-10,2021-01-05,2024-08-16,2013-11-25,2013-11-28,ESTIMATED,2024-08-16,2024-08-22,ACTUAL,2021-01-05,2021-01-08,ACTUAL,2024-08-16,2024-08-22,ACTUAL,2013-11,ACTUAL,2013-11-30,2024-08,2024-08-31,2020-01-06,ACTUAL,2020-01-06,2020-01-06,ACTUAL,2020-01-06,,INTERVENTIONAL,,"Baseline characteristics and study results were only collected as the combined total from participants per study phase. Baseline characteristics were not collected per dose level and thus cannot be reported per dose level.~Baseline characteristics were collected from all participants who enrolled/consented in Phase 1 (n=33) and Phase 2 (n=25). Of those 33 enrolled in Phase 1, 26 received the study interventions and only those 26 are counted in the Participant Flow.",Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies,Phase I/IIa Study of the Oral 5-Azacitidine in Combination With the Histone Deacetylase Inhibitor Romidepsin for the Treatment of Patients With Relapsed and Refractory Lymphoid Malignancies,TERMINATED,,PHASE1/PHASE2,58.0,ACTUAL,Columbia University,,7.0,,PI left institution,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,OTHER,,,,,,,2020,0.0
NCT04529499,,2020-08-19,2022-03-10,,2022-03-17,2020-08-26,2020-08-27,ACTUAL,2022-03-17,2022-03-21,ACTUAL,,,,2022-03-17,2022-03-21,ACTUAL,2020-08-22,ACTUAL,2020-08-22,2022-03,2022-03-31,2021-01-27,ACTUAL,2021-01-27,2021-01-22,ACTUAL,2021-01-22,,INTERVENTIONAL,,,Clinical Trial Evaluating the Efficacy and Safety of Favipiravir in Moderate to Severe COVID-19 Patients,"A Multi-center, Randomized, Double Blind, Placebo Controlled Clinical Trial Evaluating the Efficacy and Safety of Favipiravir in Moderate to Severe COVID-19 Patients",TERMINATED,,PHASE3,353.0,ACTUAL,Dr. Reddy's Laboratories Limited,,2.0,,Study met pre-defined criteria for futility at interim analysis,f,,,,t,t,f,,,,,,,,,,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,INDUSTRY,,,,,,,2021,0.0
NCT03818997,,2019-01-24,,,2020-02-03,2019-01-24,2019-01-28,ACTUAL,,,,,,,2020-02-03,2020-02-05,ACTUAL,2019-12,ESTIMATED,2019-12-31,2020-02,2020-02-29,2022-04,ESTIMATED,2022-04-30,2021-04,ESTIMATED,2021-04-30,,INTERVENTIONAL,DYNAMIC,,Combination of Targeted and Immunotherapy for Advanced Biliary Tract and Esophagogastric Gastric Cancer,DKN-01/Atezolizumab as Second Line Treatment of biliarY Tract Cancer and in combiNAtion or Not With Paclitaxel as Second Line treatMent of esophagogastrIC Cancer: a Multi-center Phase II Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,European Organisation for Research and Treatment of Cancer - EORTC,,3.0,,Company decision,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,NETWORK,,,,,,,2022,0.0
NCT04939428,,2021-06-24,2023-11-06,,2024-09-10,2021-06-24,2021-06-25,ACTUAL,2024-01-12,2024-02-06,ACTUAL,,,,2024-09-10,2024-09-26,ACTUAL,2021-08-11,ACTUAL,2021-08-11,2024-09,2024-09-30,2022-11-16,ACTUAL,2022-11-16,2022-11-16,ACTUAL,2022-11-16,,INTERVENTIONAL,MOVe-AHEAD,,Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013),"A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) in Adults Residing With a Person With COVID-19",COMPLETED,,PHASE3,2441.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,INDUSTRY,,,,,,,2022,1.0
NCT05381363,,2022-05-18,,,2023-12-27,2022-05-18,2022-05-19,ACTUAL,,,,,,,2023-12-27,2023-12-29,ACTUAL,2022-01-01,ACTUAL,2022-01-01,2023-12,2023-12-31,2023-01-01,ACTUAL,2023-01-01,2023-01-01,ACTUAL,2023-01-01,,INTERVENTIONAL,,,Inhaled Interferon α2b Treatment in Mild-to-moderate COVID-19 Infected Children,Inhaled Interferon α2b Treatment in Mild-to-moderate COVID-19 Infected Children,TERMINATED,,PHASE1/PHASE2,24.0,ACTUAL,Children's Hospital of Fudan University,,2.0,,"The study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.",f,,,,,f,f,,,,,,,,,NO,,2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,OTHER,,,,,,,2023,0.0
NCT03635996,,2018-08-14,2023-03-08,2021-03-23,2023-04-04,2018-08-14,2018-08-17,ACTUAL,2023-04-04,2023-04-24,ACTUAL,,2023-04-24,ACTUAL,2023-04-04,2023-04-24,ACTUAL,2018-12-10,ACTUAL,2018-12-10,2021-03,2021-03-31,2020-11-13,ACTUAL,2020-11-13,2020-11-13,ACTUAL,2020-11-13,,INTERVENTIONAL,,Safety population,Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (PSVT). NODE-302,"Multi-Centre, Open-Label, Safety Study of Etripamil Nasal Spray in Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia The NODE-302 Trial (Extension of NODE-301)",TERMINATED,,PHASE3,169.0,ACTUAL,Milestone Pharmaceuticals Inc.,,1.0,,Study was stopped by the Sponsor,f,,,,t,t,f,,,,,,,,,,,2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,OTHER,,,,,,,2020,0.0
NCT03976375,,2019-06-03,2024-07-30,,2024-09-10,2019-06-03,2019-06-06,ACTUAL,2024-07-30,2024-08-22,ACTUAL,,,,2024-09-10,2024-09-26,ACTUAL,2019-06-26,ACTUAL,2019-06-26,2024-09,2024-09-30,2024-08-22,ACTUAL,2024-08-22,2023-08-11,ACTUAL,2023-08-11,,INTERVENTIONAL,,,Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008),"A Phase 3, Multicenter, Randomized, Open-label Trial to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Docetaxel in Previously Treated Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (LEAP-008)",COMPLETED,,PHASE3,422.0,ACTUAL,Merck Sharp & Dohme LLC,,3.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,INDUSTRY,,,,,,,2024,1.0
NCT03289455,,2017-09-11,2020-11-18,,2021-01-11,2017-09-18,2017-09-21,ACTUAL,2021-01-11,2021-02-01,ACTUAL,,,,2021-01-11,2021-02-01,ACTUAL,2017-06-26,ACTUAL,2017-06-26,2021-01,2021-01-31,2020-05-18,ACTUAL,2020-05-18,2020-05-18,ACTUAL,2020-05-18,,INTERVENTIONAL,AMELIA,Patients infused with AUTO3,CD19 /22 CAR T Cells (AUTO3) for the Treatment of B Cell Acute Lymphoblastic Leukemia (ALL),"A Single-Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity Of AUTO3, a CAR T Cell Treatment Targeting CD19 And CD22 in Paediatric And Young Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia",COMPLETED,,PHASE1/PHASE2,23.0,ACTUAL,Autolus Limited,Early completion of the study leading to small numbers of patients analyzed from the Phase I part of the study.,1.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,INDUSTRY,,,,,,,2020,1.0
NCT03860077,,2019-02-15,2023-09-05,,2023-12-15,2019-02-28,2019-03-01,ACTUAL,2023-12-15,2023-12-19,ACTUAL,,,,2023-12-15,2023-12-19,ACTUAL,2019-10-10,ACTUAL,2019-10-10,2023-12,2023-12-31,2022-03-23,ACTUAL,2022-03-23,2022-03-23,ACTUAL,2022-03-23,,INTERVENTIONAL,SIREN,Characteristics of randomized participants,"Impact of Nicotine Reduction on Adolescent Cigarette Use, Alternative Tobacco Use, and Harm From Tobacco","Impact of Nicotine Reduction on Adolescent Cigarette Use, Alternative Tobacco Use, and Harm From Tobacco",COMPLETED,,PHASE1/PHASE2,57.0,ACTUAL,Brown University,"The study enrollment was slowed due to programming of the smartphone app; we intended to make up enrollment numbers, however, the COVID-19 pandemic severely affected our ability to recruit. We lost several months of recruitment due to shutdowns, and post-COVID recruitment rates were much lower than pre-COVID; perhaps due to concerns about in-person sessions despite measures taken to reduce contact.",2.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,"The investigators involved in this project intend to share findings from its research through publications and presentations. After all data have been collected and the results of the study have been published, de-identified data will be made available to other qualified investigators upon request. Institutions and/or individuals wishing to access any resources or data must contact the Principal Investigators. Persons requesting data must do so in writing, identifying their affiliation and how and by whom the data will be used. The request will be evaluated by the PIs and Co-Investigators to ensure that it meets reasonable demands of scientific integrity.",2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,OTHER,,,,,,,2022,1.0
NCT03074695,,2017-02-16,2021-11-05,,2022-05-27,2017-03-03,2017-03-09,ACTUAL,2022-05-27,2022-06-01,ACTUAL,,,,2022-05-27,2022-06-01,ACTUAL,2017-04-01,ACTUAL,2017-04-01,2022-05,2022-05-31,2020-11-06,ACTUAL,2020-11-06,2020-11-06,ACTUAL,2020-11-06,,INTERVENTIONAL,,,DPE Technique in Labor Epidural for Morbidly Obese Women,A Randomized Controlled Trial for Epidural Labor Analgesia: Comparison of Dural Puncture Epidural With Standard Labor Epidural Techniques,COMPLETED,,PHASE4,141.0,ACTUAL,Duke University,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,OTHER,,,,,,,2020,1.0
NCT03687632,,2018-09-24,,2021-08-13,2021-08-13,2018-09-25,2018-09-27,ACTUAL,,,,2021-08-13,2021-08-18,ACTUAL,2021-08-13,2021-08-18,ACTUAL,2019-06-10,ACTUAL,2019-06-10,2021-08,2021-08-31,2020-08-25,ACTUAL,2020-08-25,2020-08-18,ACTUAL,2020-08-18,,INTERVENTIONAL,,,ST266 Eye Drops for the Treatment of Persistent Corneal Epithelial Defects,A Phase 2 Open Label Trial of ST266 Eye Drops in the Treatment of Persistent Corneal Epithelial Defects,COMPLETED,,PHASE2,13.0,ACTUAL,"Noveome Biotherapeutics, formerly Stemnion",,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,INDUSTRY,,,,,,,2020,1.0
NCT03178487,,2017-06-05,2021-05-06,2019-11-12,2023-02-06,2017-06-05,2017-06-07,ACTUAL,2021-05-06,2021-06-01,ACTUAL,2019-11-21,2019-11-25,ACTUAL,2023-02-06,2023-03-07,ACTUAL,2017-10-24,ACTUAL,2017-10-24,2023-02,2023-02-28,2022-02-17,ACTUAL,2022-02-17,2019-01-21,ACTUAL,2019-01-21,,INTERVENTIONAL,SELECT-AXIS 1,The full analysis set (FAS) includes all randomized participants who received at least one dose of study drug.,A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing Spondylitis,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis",COMPLETED,,PHASE2,187.0,ACTUAL,AbbVie,,2.0,,,f,,,,t,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,INDUSTRY,,,,,,,2022,1.0
NCT04361058,,2020-04-15,,,2023-12-01,2020-04-21,2020-04-24,ACTUAL,,,,,,,2023-12-01,2023-12-05,ACTUAL,2020-04-13,ACTUAL,2020-04-13,2021-04,2021-04-30,2021-04-20,ACTUAL,2021-04-20,2021-04-20,ACTUAL,2021-04-20,,INTERVENTIONAL,,,Nivolumab for High-Risk MDS/AML Patients After Allogeneic Stem Cell Transplant With Post-Transplant Cyclophosphamide,Graft-Versus-Tumor Augmentation With Nivolumab for High-Risk Patients With MDS and AML After Allogeneic Stem Cell Transplantation Using Post-Transplantation Cyclophosphamide,WITHDRAWN,,PHASE1,0.0,ACTUAL,"SCRI Development Innovations, LLC",,2.0,,The single site that was deemed appropriate for this study was unable to enroll patients. Closed due to slow accrual.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,OTHER,,,,,,,2021,0.0
NCT04355364,,2020-04-15,,,2021-12-20,2020-04-17,2020-04-21,ACTUAL,,,,,,,2021-12-20,2022-01-11,ACTUAL,2020-04-21,ACTUAL,2020-04-21,2021-12,2021-12-31,2021-12-20,ACTUAL,2021-12-20,2021-12-20,ACTUAL,2021-12-20,,INTERVENTIONAL,COVIDORNASE,,Efficacy and Safety of aerosolizedDornase Alfa Administration in Patients With COVID19 Induced ARDS (COVIDORNASE),Efficacy and Safety of Dornase Alfa Aerosol in ARDS Secondary to SARS-CoV-2 Coronavirus Respiratory Infection - COVID-19,TERMINATED,,PHASE3,77.0,ACTUAL,Fondation Ophtalmologique Adolphe de Rothschild,,2.0,,No signal of benefit of treatment.,f,,,,,f,f,,,,,,,,,NO,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,NETWORK,,,,,,,2021,0.0
NCT04356937,,2020-04-19,2021-06-23,,2021-07-23,2020-04-19,2020-04-22,ACTUAL,2021-07-23,2021-07-27,ACTUAL,,,,2021-07-23,2021-07-27,ACTUAL,2020-04-20,ACTUAL,2020-04-20,2021-07,2021-07-31,2020-08-27,ACTUAL,2020-08-27,2020-07-13,ACTUAL,2020-07-13,,INTERVENTIONAL,,All randomized patients,Efficacy of Tocilizumab on Patients With COVID-19,Tocilizumab to Prevent the Progression of Hypoxemic Respiratory Failure in Hospitalized Non-Critically Ill Patients With COVID-19,COMPLETED,,PHASE3,243.0,ACTUAL,Massachusetts General Hospital,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,Request for IPD can be submitted to PI for review,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,OTHER,,,,,,,2020,1.0
NCT05153174,,2021-11-29,2024-05-24,,2024-08-08,2021-11-29,2021-12-10,ACTUAL,2024-08-08,2024-08-12,ACTUAL,,,,2024-08-08,2024-08-12,ACTUAL,2022-05-02,ACTUAL,2022-05-02,2024-08,2024-08-31,2023-06-08,ACTUAL,2023-06-08,2023-05-25,ACTUAL,2023-05-25,,INTERVENTIONAL,,,Study of Sulphoraphane in Chronic Kidney Disease,"Safety, Feasibility and Efficacy of Sulforaphane (Avmacol) in Chronic Kidney Disease",COMPLETED,,PHASE1,18.0,ACTUAL,University of Rochester,"At the time of review with the Data Safety Monitoring Committee, the study had consented 21 patients and enrolled 18 patients out of 24 targeted. 2 of the 21 patients were randomized to a 6-tablet Arm, which was removed in the final Protocol Amendment due to moderate side effects/adverse events. 1 patient withdrew before study procedures.",2.0,,,f,,,,t,t,f,,,,,,May 2024 data is available. End date to be determined.,clinicaltrials.gov,,YES,IPD will be shared after publication,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,OTHER,,,,,,,2023,1.0
NCT02706626,,2016-03-08,2022-04-28,,2023-01-10,2016-03-08,2016-03-11,ESTIMATED,2023-01-10,2023-01-26,ACTUAL,,,,2023-01-10,2023-01-26,ACTUAL,2017-03-09,ACTUAL,2017-03-09,2023-01,2023-01-31,2021-04-01,ACTUAL,2021-04-01,2020-10-08,ACTUAL,2020-10-08,,INTERVENTIONAL,,Patients were enrolled and assigned to a cohort based on previous treatment. Cohort A enrolled patients with disease progression on a next generation ALK TKI regardless of the number of lines of therapy. Cohort B enrolled patients who had received first line alectinib. Cohort C enrolled patients with disease progression on standard dose brigatinib and who tolerated the therapy,Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors,Phase 2 Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors in Refractory ALK Rearranged Non-Small Cell Lung Cancer (NSCLC),TERMINATED,,PHASE2,32.0,ACTUAL,"Criterium, Inc.",The study was terminated for slow accrual. The enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results,3.0,,Did not meet enrollment objectives.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,INDUSTRY,,,,,,,2021,0.0
NCT04072874,,2019-08-22,,,2022-06-02,2019-08-27,2019-08-28,ACTUAL,,,,,,,2022-06-02,2022-06-03,ACTUAL,2021-01,ESTIMATED,2021-01-31,2020-11,2020-11-30,2022-07,ESTIMATED,2022-07-31,2021-02,ESTIMATED,2021-02-28,,INTERVENTIONAL,Curaleish,,Evaluation of the Safety and Clinical Activity of Curaleish in the Topical Treatment of Cutaneous Leishmaniasis.,Evaluation of the Safety and Clinical Activity of Curaleish Lotion and Cream in the Topical Treatment of Cutaneous Leishmaniasis in Colombia,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Universidad de Antioquia,,2.0,,Tthe study is in the approval phase by local regulatory authorities,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,OTHER,,,,,,,2022,0.0
NCT03366857,,2017-12-02,,,2020-06-08,2017-12-06,2017-12-08,ACTUAL,,,,,,,2020-06-08,2020-06-11,ACTUAL,2017-12-01,ACTUAL,2017-12-01,2020-06,2020-06-30,2020-05-30,ACTUAL,2020-05-30,2019-12-31,ACTUAL,2019-12-31,,INTERVENTIONAL,,,Effect of Supplemental Oxygen on Perioperative BNP Concentration in Cardiac Risk Patients,Effect of Supplemental Oxygen on Perioperative Brain Natriuretic Peptide Concentration in Cardiac Risk Patients - A Prospective Randomized Clinical Trial,COMPLETED,,PHASE4,260.0,ACTUAL,Medical University of Vienna,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,OTHER,,,,,,,2020,0.0
NCT03345953,,2017-11-09,,,2020-07-28,2017-11-14,2017-11-17,ACTUAL,,,,,,,2020-07-28,2020-07-30,ACTUAL,2018-02-06,ACTUAL,2018-02-06,2020-07,2020-07-31,2020-04-29,ACTUAL,2020-04-29,2020-04-29,ACTUAL,2020-04-29,,INTERVENTIONAL,P13-04,,Clinical Trial Assessing the Efficacy and Safety of BP1.4979 in Restless Legs Syndrome,"Randomized Double Blind Parallel Groups Sequential, Placebo Controlled, Trial Assessing the Efficacy and Safety of BP1.4979 in Restless Legs Syndrome (RLS)",TERMINATED,,PHASE2,29.0,ACTUAL,Bioprojet,,2.0,,Study facing recruitment difficulties related to stringent eligibility criteria,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,OTHER,,,,,,,2020,0.0
NCT04138485,,2019-10-14,,,2020-11-16,2019-10-22,2019-10-24,ACTUAL,,,,,,,2020-11-16,2020-11-17,ACTUAL,2019-12-20,ACTUAL,2019-12-20,2020-11,2020-11-30,2020-09-16,ACTUAL,2020-09-16,2020-09-16,ACTUAL,2020-09-16,,INTERVENTIONAL,,,Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc),"A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults With Systemic Sclerosis",WITHDRAWN,,PHASE2,0.0,ACTUAL,CSL Behring,,2.0,,"Due to business reasons, not safety issues",f,,,,t,t,f,,,f,,,IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.,Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.~An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.~The requesting party must execute an appropriate data sharing agreement before IPD will be made available.,,YES,"CSL will consider requests to share Individual Patient Data (IPD) from systemic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.~Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.~If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.",2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,INDUSTRY,,,,,,,2020,0.0
NCT01239797,,2010-11-08,2016-08-04,,2022-05-05,2010-11-10,2010-11-11,ESTIMATED,2017-01-04,2017-01-05,ESTIMATED,,,,2022-05-05,2022-06-01,ACTUAL,2011-06-20,ACTUAL,2011-06-20,2022-05,2022-05-31,2021-04-21,ACTUAL,2021-04-21,2014-09-02,ACTUAL,2014-09-02,,INTERVENTIONAL,ELOQUENT - 2,Randomized: all participants randomized to any treatment group,Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma,"Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)",COMPLETED,,PHASE3,646.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,INDUSTRY,,,,,,,2021,1.0
NCT03455517,,2018-02-28,,,2023-11-22,2018-02-28,2018-03-06,ACTUAL,,,,,,,2023-11-22,2023-11-24,ACTUAL,2018-10-31,ACTUAL,2018-10-31,2023-11,2023-11-30,2023-05-11,ACTUAL,2023-05-11,2021-09-05,ACTUAL,2021-09-05,,INTERVENTIONAL,VeRitAs,,Activity and Safety of Front-line Venetoclax and Rituximab in Young and Fit Patients With Chronic Lymphocytic Leukemia,Activity and Safety of Front-linevenetoclax and Rituximab Association (VeRiTAs) in Young and Fit Patients With Chronic Lymphocytic Leukemia (CLL) and Umutated IGVH and/or Disrupted TP53. A Phase 2 Multicenter Study,COMPLETED,,PHASE2,77.0,ACTUAL,Gruppo Italiano Malattie EMatologiche dell'Adulto,,1.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,OTHER,,,,,,,2023,1.0
NCT04838847,,2021-04-08,,,2021-08-16,2021-04-08,2021-04-09,ACTUAL,,,,,,,2021-08-16,2021-08-20,ACTUAL,2021-10-01,ESTIMATED,2021-10-01,2021-04,2021-04-30,2022-09,ESTIMATED,2022-09-30,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,,,A Study to Evaluate the Immunogenicity and Safety of the SARS-CoV-2 mRNA Vaccine CVnCoV in Elderly Adults Compared to Younger Adults for COVID-19,"COVID-19 (CoviCompareCV): A Phase 3, Non-randomized, Open Label Clinical Trial to Evaluate the Immunogenicity and Safety of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV Administered Intramuscularly in Adults Aged 65 Years or Above Compared to Younger Adults Aged 18-45 Years",WITHDRAWN,,PHASE3,0.0,ACTUAL,CureVac,,2.0,,The study was withdrawn based on an assessment of immunogenicity in elderly adults.,f,,,,f,f,f,,,,,,,,,,,2024-10-17 01:25:09.472086,2024-10-17 01:25:09.472086,INDUSTRY,,,,,,,2022,0.0
NCT04304716,,2020-03-09,,,2020-03-17,2020-03-09,2020-03-11,ACTUAL,,,,,,,2020-03-17,2020-03-18,ACTUAL,2020-03,ESTIMATED,2020-03-31,2020-03,2020-03-31,2021-03,ESTIMATED,2021-03-31,2021-03,ESTIMATED,2021-03-31,,INTERVENTIONAL,,,Regional Anesthesia for Head and Neck Reconstruction,Regional Anesthesia for the Management of Perioperative Pain for Free Flap Reconstruction of the Head and Neck: A Randomized Prospective Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Florida,,6.0,,Withdrawn from the IRB,f,,,,,t,f,,,t,,,,,,,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,OTHER,,,,,,,2021,0.0
NCT03927274,,2019-04-23,,,2023-05-24,2019-04-23,2019-04-25,ACTUAL,,,,,,,2023-05-24,2023-05-25,ACTUAL,2019-06-20,ACTUAL,2019-06-20,2023-05,2023-05-31,2023-05-24,ACTUAL,2023-05-24,2023-05-24,ACTUAL,2023-05-24,,INTERVENTIONAL,,,Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade III/ IV Glioma,A Study of Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery (CED) in Patients With Suspected Recurrent/Progressive World Health Organization (WHO) Grade III or IV (High Grade) Glioma Undergoing Stereotactic Biopsy,TERMINATED,,EARLY_PHASE1,3.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,1.0,,Funding unavailable,,,,,f,t,f,,,,,,,,,,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,OTHER,,,,,,,2023,0.0
NCT05192265,,2021-12-21,,,2022-03-29,2022-01-10,2022-01-14,ACTUAL,,,,,,,2022-03-29,2022-04-07,ACTUAL,2019-05-20,ACTUAL,2019-05-20,2022-03,2022-03-31,2020-12-23,ACTUAL,2020-12-23,2020-12-23,ACTUAL,2020-12-23,,INTERVENTIONAL,,,Efficacy and Safety of Pyronaridine-Artesunate Versus Artemether-Lumefantrine,Comparative Efficacy and Safety of Pyronaridine-Artesunate Versus Artemether-Lumefantrine in The Treatment of Acute Uncomplicated Malaria Among Children In South-West Nigeria,COMPLETED,,PHASE2/PHASE3,172.0,ACTUAL,University of Ibadan,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,OTHER,,,,,,,2020,1.0
NCT03098680,,2017-03-14,,,2021-03-18,2017-03-28,2017-04-04,ACTUAL,,,,,,,2021-03-18,2021-03-22,ACTUAL,2017-04-24,ACTUAL,2017-04-24,2021-03,2021-03-31,2020-02-29,ACTUAL,2020-02-29,2020-02-29,ACTUAL,2020-02-29,,INTERVENTIONAL,PRIME,,A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems,A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems,TERMINATED,,PHASE1,18.0,ACTUAL,Cambridge University Hospitals NHS Foundation Trust,,2.0,,Unable to recruit in time before end of PhD studentship,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,OTHER,,,,,,,2020,0.0
NCT04870164,,2021-04-28,,,2022-03-03,2021-04-28,2021-05-03,ACTUAL,,,,,,,2022-03-03,2022-03-18,ACTUAL,2020-11-18,ACTUAL,2020-11-18,2022-03,2022-03-31,2022-01-06,ACTUAL,2022-01-06,2022-01-06,ACTUAL,2022-01-06,,INTERVENTIONAL,,,"Safety, Tolerability and PK of Ensovibep (MP0420 - a New Candidate With Potential for Treatment of COVID-19)","A Phase 1, First-time-in-human, Dose Ascending Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MP0420 (a Novel Drug Candidate With Potential for Treatment of COVID-19) in Healthy Volunteers",TERMINATED,,PHASE1,53.0,ACTUAL,Molecular Partners AG,,14.0,,"Due to hypersensitivity observed in 3 subjects, although no stopping rules were met, the Sponsor decided to halt recruitment for further investigation. After analysis of PK, i.m. administration was not required, and recruitment stopped.",f,,,,,f,f,,,,,,,,,,,2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,INDUSTRY,,,,,,,2022,0.0
NCT05039736,,2021-09-01,,,2023-05-10,2021-09-01,2021-09-10,ACTUAL,,,,,,,2023-05-10,2023-05-12,ACTUAL,2023-02-24,ESTIMATED,2023-02-24,2023-05,2023-05-31,2023-05-03,ACTUAL,2023-05-03,2023-05-03,ACTUAL,2023-05-03,,INTERVENTIONAL,,,"A Phase II Study to Evaluate the Effects of Sequential Therapy With the Anti c-MET/VEGFR Tyrosine Kinase Inhibitor (TKI), Cabozantinib, Followed by an Anti-PD-1 Antibody (Nivolumab) in Patients With Advanced HCC Who Progressed on First-line Therapy","A Phase II Study to Evaluate the Effects of Sequential Therapy With the Anti c-MET/VEGFR Tyrosine Kinase Inhibitor (TKI), Cabozantinib, Followed by an Anti-PD-1 Antibody (Nivolumab) in Patients With Advanced HCC Who Progressed on First-line Therapy",WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,0 participants accrued,,,,,t,t,f,,,,,,,,,,,2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,OTHER,,,,,,,2023,0.0
NCT04541225,,2020-08-21,,,2023-07-12,2020-09-01,2020-09-09,ACTUAL,,,,,,,2023-07-12,2023-07-14,ACTUAL,2020-12-08,ACTUAL,2020-12-08,2023-07,2023-07-31,2022-08-31,ACTUAL,2022-08-31,2022-08-31,ACTUAL,2022-08-31,,INTERVENTIONAL,,,Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors,"Phase 1/2 Dose Escalation, Safety, Pharmacokinetics, and Efficacy Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors",TERMINATED,,PHASE1,74.0,ACTUAL,Nuvation Bio Inc.,,1.0,,Sponsor decision,f,,,,,t,f,,,,,,,,,,,2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,INDUSTRY,,,,,,,2022,0.0
NCT05205668,,2022-01-17,,,2023-09-28,2022-01-23,2022-01-25,ACTUAL,,,,,,,2023-09-28,2023-10-02,ACTUAL,2022-04-08,ACTUAL,2022-04-08,2023-09,2023-09-30,2023-04-08,ACTUAL,2023-04-08,2022-04-08,ACTUAL,2022-04-08,,INTERVENTIONAL,,,Study of F-652 in Subjects With Corona Virus Disease 2019 (COVID-19) Pneumonia,"A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of F-652 in Subjects With COVID-19 Pneumonia",WITHDRAWN,,PHASE2,0.0,ACTUAL,EVIVE Biotechnology,,3.0,,Compound development plan changed,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,INDUSTRY,,,,,,,2023,0.0
NCT03859570,,2019-02-22,,,2021-01-28,2019-02-27,2019-03-01,ACTUAL,,,,,,,2021-01-28,2021-02-02,ACTUAL,2020-09-01,ESTIMATED,2020-09-01,2021-01,2021-01-31,2022-12,ESTIMATED,2022-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,Pentoxifylline,,Pentoxifylline in Lupus Nephritis,"A Multicenter, Double-blind, Placebo-controlled, Randomized Trial of Pentoxifylline or Placebo in Addition to Standard of Care for Treatment of Proteinuria in Patients With Lupus Nephritis.",WITHDRAWN,,PHASE4,0.0,ACTUAL,MetroHealth Medical Center,,2.0,,Study not selected to receive funding,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,OTHER,,,,,,,2022,0.0
NCT04161391,,2019-11-11,2024-05-21,,2024-05-21,2019-11-11,2019-11-13,ACTUAL,2024-05-21,2024-06-13,ACTUAL,,,,2024-05-21,2024-06-13,ACTUAL,2019-12-06,ACTUAL,2019-12-06,2024-05,2024-05-31,2023-05-22,ACTUAL,2023-05-22,2023-05-22,ACTUAL,2023-05-22,,INTERVENTIONAL,,,"Study of TPX-0046, A RET/SRC Inhibitor in Adult Subjects With Advanced Solid Tumors Harboring RET Fusions or Mutations","A Phase 1/2 Study of TPX-0046, A Novel Oral RET/SRC Inhibitor in Adult Subjects With Advanced/Metastatic Solid Tumors Harboring Oncogenic RET Fusions or Mutations",TERMINATED,,PHASE1/PHASE2,41.0,ACTUAL,"Turning Point Therapeutics, Inc.","As the study enrollment will close prior to completing Phase 1 dose escalation, the Phase 1 food effect substudy, Phase 1 dose expansion, and Phase 2 activities will not take place.",1.0,,Adverse change in the risk/benefit.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,INDUSTRY,,,,,,,2023,0.0
NCT05139901,,2021-11-30,,,2023-02-21,2021-11-30,2021-12-01,ACTUAL,,,,,,,2023-02-21,2023-02-23,ACTUAL,2021-12-01,ACTUAL,2021-12-01,2023-02,2023-02-28,2023-02-22,ACTUAL,2023-02-22,2023-02-22,ACTUAL,2023-02-22,,INTERVENTIONAL,,,Usefulness of DORNASE in COVID-19 on HFNO,Usefulness of DORNASE (Pulmozyme®) in Patients With COVID-19 Respiratory Insufficiency on High-Flow Oxygen Therapy,TERMINATED,,PHASE4,10.0,ACTUAL,University Medical Centre Ljubljana,,2.0,,Due to the Omicron version of SARS-CoV-2 the COVID-pneumonia patients ran out,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,OTHER,,,,,,,2023,0.0
NCT04603937,,2020-10-21,2024-07-25,,2024-08-20,2020-10-26,2020-10-27,ACTUAL,2024-08-20,2024-08-22,ACTUAL,,,,2024-08-20,2024-08-22,ACTUAL,2020-09-30,ACTUAL,2020-09-30,2024-08,2024-08-31,2023-08-31,ACTUAL,2023-08-31,2023-04-27,ACTUAL,2023-04-27,,INTERVENTIONAL,GLIMMER,Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or aflibercept). Subjects will be analyzed according to their randomized treatment.,"A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)","A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME)",TERMINATED,,PHASE3,459.0,ACTUAL,Kodiak Sciences Inc,,2.0,,Study did not meet primary endpoint,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,INDUSTRY,,,,,,,2023,0.0
NCT05725343,,2022-01-12,,,2023-02-09,2023-02-09,2023-02-13,ACTUAL,,,,,,,2023-02-09,2023-02-13,ACTUAL,2022-02-03,ACTUAL,2022-02-03,2023-02,2023-02-28,2022-09-21,ACTUAL,2022-09-21,2022-04-03,ACTUAL,2022-04-03,,INTERVENTIONAL,CANAL,,A Prevention Trial of Canakinumab in Subjects at High Risk for Lung Cancer,A Phase III Prevention Trial of Canakinumab in Subjects at High Risk for Lung Cancer _ CANAL Study,TERMINATED,,PHASE3,350.0,ACTUAL,Mario Negri Institute for Pharmacological Research,,2.0,,"Novartis has decided to terminate the trial due to the recent results made available from the Novartis CANOPY A study (CACZ885T2301), this decision is not related to any safety data for Canakinumab",f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,OTHER,,,,,,,2022,0.0
NCT02851004,,2016-07-14,,,2021-08-30,2016-07-27,2016-08-01,ESTIMATED,,,,,,,2021-08-30,2021-09-05,ACTUAL,2016-10,ACTUAL,2016-10-31,2021-08,2021-08-31,2021-08-23,ACTUAL,2021-08-23,2020-02-03,ACTUAL,2020-02-03,,INTERVENTIONAL,,,Special Combination of BBI608 and Pembrolizumab,A Phase Ib/II Study of BBI608 in Combination With Pembrolizumab in Patients With Metastatic Colorectal Cancer,TERMINATED,,PHASE1/PHASE2,55.0,ACTUAL,National Cancer Center Hospital East,,1.0,,"On the request of the investigational drug provider. No subjects were newly enrolled in the additional cohort as they were preparing to resume enrollment in the additional cohort. Currently, it is preparing the creation of clinical study report.",f,,,,t,,,,,,,,,,,NO,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,OTHER,,,,,,,2021,0.0
NCT05667662,,2022-12-01,,,2024-04-01,2022-12-19,2022-12-28,ACTUAL,,,,,,,2024-04-01,2024-04-02,ACTUAL,2023-02-01,ACTUAL,2023-02-01,2024-04,2024-04-30,2024-02-27,ACTUAL,2024-02-27,2024-02-27,ACTUAL,2024-02-27,,INTERVENTIONAL,,,Study to Evaluate Itraconazole Administered as Inhaled Dry Powder in Adults With Asthma and ABPA,"Study to Evaluate the Effect of Dose and Duration of Treatment of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) on Safety, Tolerability, and Potential Outcomes in Adult Patients With ABPA",TERMINATED,,PHASE2,8.0,ACTUAL,Pulmatrix Inc.,,3.0,,Low enrollment,f,,,,t,t,f,,,,,,,,,,,2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,INDUSTRY,,,,,,,2024,0.0
NCT03087058,,2017-03-16,2022-08-26,,2022-10-17,2017-03-16,2017-03-22,ACTUAL,2022-08-26,2022-09-26,ACTUAL,,,,2022-10-17,2022-10-19,ACTUAL,2017-07-07,ACTUAL,2017-07-07,2022-10,2022-10-31,2021-04-30,ACTUAL,2021-04-30,2021-01-13,ACTUAL,2021-01-13,,INTERVENTIONAL,EMERALD,,Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia,"A Phase 2, Open-Label, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer for Oral Suspension in Children and Adolescents 2 to < 18 Years of Age With Chronic Kidney Disease and Hyperkalemia",TERMINATED,,PHASE2,23.0,ACTUAL,Vifor Pharma,,3.0,,The study was terminated on 13 May 2022 due to a modification to the PIP/PSP,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,INDUSTRY,,,,,,,2021,0.0
NCT02922413,,2016-01-01,,,2024-04-15,2016-09-29,2016-10-04,ESTIMATED,,,,,,,2024-04-15,2024-04-17,ACTUAL,2015-10-30,ACTUAL,2015-10-30,2024-04,2024-04-30,2023-12-27,ACTUAL,2023-12-27,2023-12-27,ACTUAL,2023-12-27,,INTERVENTIONAL,,,Panhematin for Prevention of Acute Attacks of Porphyria,Safety and Efficacy of Panhematin™ for Prevention of Acute Attacks of Porphyria,TERMINATED,,PHASE2,13.0,ACTUAL,"The University of Texas Medical Branch, Galveston",,2.0,,Low accrual,f,,,,t,,,,,,,,,,,,,2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,OTHER,,,,,,,2023,0.0
NCT03738618,,2018-10-24,2023-08-30,2021-11-16,2023-12-21,2018-11-09,2018-11-13,ACTUAL,2023-12-21,2024-01-18,ACTUAL,,2024-01-18,ACTUAL,2023-12-21,2024-01-18,ACTUAL,2018-10-29,ACTUAL,2018-10-29,2023-08,2023-08-31,2020-12-21,ACTUAL,2020-12-21,2020-12-21,ACTUAL,2020-12-21,,INTERVENTIONAL,RITA-2,The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment.,Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-2),"A Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Trial Investigating the Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Women Aged 35-42 Years Undergoing Assisted Reproductive Technology",COMPLETED,,PHASE3,588.0,ACTUAL,Ferring Pharmaceuticals,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,INDUSTRY,,,,,,,2020,1.0
NCT03234465,,2017-07-21,2020-10-22,,2020-11-20,2017-07-28,2017-07-31,ACTUAL,2020-11-20,2020-11-23,ACTUAL,,,,2020-11-20,2020-11-23,ACTUAL,2017-07-18,ACTUAL,2017-07-18,2020-10,2020-10-31,2020-07-13,ACTUAL,2020-07-13,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,,"Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day","A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Topically-applied AG013 for the Attenuation of Oral Mucositis in Subjects With Cancers of the Head and Neck Receiving Concomitant Chemoradiation Therapy",TERMINATED,,PHASE2,200.0,ACTUAL,"Oragenics, Inc.",,2.0,,"No efficacy could be demonstrated, sponsor decided to prematurely end the study.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,INDUSTRY,,,,,,,2020,0.0
NCT04121208,,2019-07-03,,,2024-05-07,2019-10-08,2019-10-09,ACTUAL,,,,,,,2024-05-07,2024-05-09,ACTUAL,2021-04-07,ACTUAL,2021-04-07,2024-05,2024-05-31,2022-02-18,ACTUAL,2022-02-18,2022-02-18,ACTUAL,2022-02-18,,INTERVENTIONAL,MICAD,,MIcroglial Colony Stimulating Factor-1 Receptor (CSF1R) in Alzheimer's Disease,"A Randomised, Placebo-controlled, Single-blind Study to Characterise the Biomarker Effects of the Colony Stimulating Factor-1 (CSF-1) Receptor Antagonist JNJ-40346527 in Participants With Mild Cognitive Impairment",TERMINATED,,PHASE1,2.0,ACTUAL,University of Oxford,,2.0,,Delayed due to COVID19. Study drug expired before could be used.,f,,,,t,f,f,,,,,,,,,NO,"Study terminated early after 2 participants recruited. No usable data, therefore no data will be shared.",2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,OTHER,,,,,,,2022,0.0
NCT05429021,,2022-06-15,,,2024-09-24,2022-06-17,2022-06-23,ACTUAL,,,,,,,2024-09-24,2024-09-26,ACTUAL,2022-06-03,ACTUAL,2022-06-03,2024-09,2024-09-30,2023-01-06,ACTUAL,2023-01-06,2023-01-06,ACTUAL,2023-01-06,,INTERVENTIONAL,,,IMM-BCP-01 in Mild to Moderate COVID-19,"A Randomized, Double-Blind, Placebo-Controlled, First-in-Human, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Viral Clearance of Single Ascending Doses of IMM-BCP-01 Administered Intravenously in Adults With Mild to Moderate COVID-19",TERMINATED,,PHASE1,9.0,ACTUAL,"Immunome, Inc.",,4.0,,Business decision to discontinue the study based on strategic prioritization.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,INDUSTRY,,,,,,,2023,0.0
NCT03099187,,2017-03-31,2019-11-14,,2020-12-22,2017-03-31,2017-04-04,ACTUAL,2019-12-16,2020-01-03,ACTUAL,,,,2020-12-22,2021-01-13,ACTUAL,2017-05-15,ACTUAL,2017-05-15,2020-12,2020-12-31,2020-01-10,ACTUAL,2020-01-10,2018-11-21,ACTUAL,2018-11-21,,INTERVENTIONAL,,,A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease,"Multicenter, International, Double-blind, Two-Arm, Randomized, Placebo-controlled Phase II Trial of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing ILD",COMPLETED,,PHASE2,253.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,INDUSTRY,,,,,,,2020,1.0
NCT04811040,,2021-03-19,,,2023-10-26,2021-03-19,2021-03-23,ACTUAL,,,,,,,2023-10-26,2023-10-27,ACTUAL,2021-04-08,ACTUAL,2021-04-08,2023-10,2023-10-31,2023-10-17,ACTUAL,2023-10-17,2023-04-18,ACTUAL,2023-04-18,,INTERVENTIONAL,,,Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection,"A Phase 1b Randomized, Blinded, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection",COMPLETED,,PHASE1,32.0,ACTUAL,Gilead Sciences,,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 02:18:45.957161,2024-10-15 02:18:45.957161,INDUSTRY,,,,,,,2023,1.0
NCT04325893,,2020-03-25,,,2020-10-02,2020-03-27,2020-03-30,ACTUAL,,,,,,,2020-10-02,2020-10-06,ACTUAL,2020-04-01,ACTUAL,2020-04-01,2020-04,2020-04-30,2020-06-18,ACTUAL,2020-06-18,2020-06-18,ACTUAL,2020-06-18,,INTERVENTIONAL,HYCOVID,,Hydroxychloroquine Versus Placebo in COVID-19 Patients at Risk for Severe Disease,"Hydroxychloroquine Versus Placebo in Patients Presenting COVID-19 Infection and at Risk of Secondary Complication: a Prospective, Multicentre, Randomised, Double-blind Study",TERMINATED,,PHASE3,259.0,ACTUAL,"University Hospital, Angers",,2.0,,decrease in number of eligible patients,f,,,,,f,f,,,,,,,,,,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,OTHER_GOV,,,,,,,2020,0.0
NCT05374538,,2022-05-10,,,2023-09-25,2022-05-10,2022-05-16,ACTUAL,,,,,,,2023-09-25,2023-09-28,ACTUAL,2022-11-09,ACTUAL,2022-11-09,2023-09,2023-09-30,2023-08-26,ACTUAL,2023-08-26,2023-08-26,ACTUAL,2023-08-26,,INTERVENTIONAL,,,VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer,A Phase 1a/1b Study of Aurora Kinase A Inhibitor VIC-1911 Monotherapy and in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer,TERMINATED,,PHASE1,4.0,ACTUAL,"Vitrac Therapeutics, LLC",,5.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,INDUSTRY,,,,,,,2023,0.0
NCT03876119,,2019-03-12,,,2022-05-16,2019-03-14,2019-03-15,ACTUAL,,,,,,,2022-05-16,2022-05-20,ACTUAL,2018-12-05,ACTUAL,2018-12-05,2022-05,2022-05-31,2021-05-31,ACTUAL,2021-05-31,2021-05-31,ACTUAL,2021-05-31,,INTERVENTIONAL,CHOICE,,Intraarterial Alteplase Versus Placebo After Mechanical Thrombectomy,CHemical OptImization of Cerebral Embolectomy in Patients With Acute Stroke Treated With Mechanical Thrombectomy (CHOICE) Trial,COMPLETED,,PHASE2/PHASE3,121.0,ACTUAL,Hospital Clinic of Barcelona,,2.0,,,f,,,,t,f,f,,,f,,,The data will become available after publication of main study results.,The IPD will be available from the Sponsor of the trial on reasonable request.,,YES,Deidentified individual participant data on outcome measures will be published along with the main results of the trial.,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,OTHER,,,,,,,2021,1.0
NCT04465916,,2020-07-06,2022-08-22,,2022-10-11,2020-07-09,2020-07-10,ACTUAL,2022-09-21,2022-10-12,ACTUAL,,,,2022-10-11,2022-11-02,ACTUAL,2020-05-12,ACTUAL,2020-05-12,2022-10,2022-10-31,2021-11-25,ACTUAL,2021-11-25,2021-06-17,ACTUAL,2021-06-17,,INTERVENTIONAL,,,Study of EYP001a to Assess Its Safety and Anti-viral Effect in CHB Patients in Combination With NA (ETV or TD),"A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of Oral FXR Modulator EYP001a Combined With Nucleos(t)Ide Analogues (NA) in Virologically Suppressed Chronic Hepatitis B Patients to Improve Functional Cure Rates",TERMINATED,,PHASE2,26.0,ACTUAL,Enyo Pharma,,2.0,,DSMC reviewed results of 26 subjects. New randomizations were stopped. Already randomized subjects were followed up to W40.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,INDUSTRY,,,,,,,2021,0.0
NCT04210986,,2019-12-03,2024-03-29,2023-12-29,2024-09-04,2019-12-20,2019-12-26,ACTUAL,2024-09-04,2024-09-19,ACTUAL,,2024-09-19,ACTUAL,2024-09-04,2024-09-19,ACTUAL,2020-01-06,ACTUAL,2020-01-06,2024-09,2024-09-30,2023-02-01,ACTUAL,2023-02-01,2023-01-05,ACTUAL,2023-01-05,,INTERVENTIONAL,,All randomized.,Senolytic Drugs Attenuate Osteoarthritis-Related Articular Cartilage Degeneration: A Clinical Trial,Senolytic Drugs Attenuate Osteoarthritis-Related Articular Cartilage Degeneration: A Clinical Trial,COMPLETED,,PHASE1/PHASE2,75.0,ACTUAL,Steadman Philippon Research Institute,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,OTHER,,,,,,,2023,1.0
NCT05205447,,2022-01-05,,,2022-12-27,2022-01-19,2022-01-25,ACTUAL,,,,,,,2022-12-27,2022-12-28,ACTUAL,2022-01-05,ACTUAL,2022-01-05,2022-12,2022-12-31,2022-04-12,ACTUAL,2022-04-12,2022-04-12,ACTUAL,2022-04-12,,INTERVENTIONAL,,,Study of the Effects of Itraconazole and Carbamazepine on LY3410738 in Healthy Participants,"A Phase 1, Two-part, Open-label, Fixed-sequence Study to Evaluate the Effects of Multiple Doses of Itraconazole and Carbamazepine on the Single-dose Pharmacokinetics of LY3410738 in Healthy Adult Subjects",TERMINATED,,PHASE1,27.0,ACTUAL,Eli Lilly and Company,,4.0,,Data from part 2 no longer deemed necessary for this program.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 16:30:55.251326,2024-10-15 16:30:55.251326,INDUSTRY,,,,,,,2022,0.0
NCT03970382,,2019-05-06,,,2022-08-16,2019-05-30,2019-05-31,ACTUAL,,,,,,,2022-08-16,2022-08-18,ACTUAL,2019-07-03,ACTUAL,2019-07-03,2022-08,2022-08-31,2022-08-12,ESTIMATED,2022-08-12,2022-08-12,ESTIMATED,2022-08-12,,INTERVENTIONAL,,,A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors,"A Phase 1a/1b, Open-label First-in-human Study of the Safety, Tolerability and Feasibility of Gene-edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors",SUSPENDED,,PHASE1,21.0,ACTUAL,"PACT Pharma, Inc.",,3.0,,Business decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,INDUSTRY,,,,,,,2022,0.0
NCT04066478,,2019-08-22,,,2022-06-17,2019-08-22,2019-08-26,ACTUAL,,,,,,,2022-06-17,2022-06-23,ACTUAL,2017-10-08,ACTUAL,2017-10-08,2022-06,2022-06-30,2022-12-31,ESTIMATED,2022-12-31,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,DHEA,,Does DHEA IVF Outcomes in Poor Responders?,"Does Dehydroepiandrosterone (DHEA) Improve IVF Outcomes in Poor Responders? A Randomised, Double-blind, Placebo Controlled Trial",SUSPENDED,,PHASE2/PHASE3,400.0,ESTIMATED,Homerton University Hospital NHS Foundation Trust,,2.0,,Sponsor,f,,,,t,f,f,,,,,,,,,,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,OTHER,,,,,,,2022,0.0
NCT05022329,,2021-08-23,,,2023-05-02,2021-08-25,2021-08-26,ACTUAL,,,,,,,2023-05-02,2023-05-06,ACTUAL,2021-09-30,ACTUAL,2021-09-30,2023-05,2023-05-31,2022-11-15,ACTUAL,2022-11-15,2022-05-11,ACTUAL,2022-05-11,,INTERVENTIONAL,BOOST KIDNEY,,COVID-19 Vaccine Boosters in Patients With CKD,A Multi-Centre 12 Month Parallel-Group Randomized Control Trial of BNT162b2 Versus mRNA( Messenger Ribonucleic Acid) -1273 COVID-19 Vaccine Boosters in Chronic Kidney Disease and Dialysis Patients With Poor Humoral Response Following COVID-19 ( Corona Virus Disease of 2019)Vaccination,TERMINATED,,PHASE2/PHASE3,268.0,ACTUAL,Sunnybrook Health Sciences Centre,,4.0,,"Trial participants became eligible to receive their 4th dose of the COVID-19 vaccine vaccine thus data collected from the 12 month follow-up after 3rd dose vaccine, as per current protocol, would not not be relevant to the study outcomes.",f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,OTHER,,,,,,,2022,0.0
NCT05142527,,2021-12-01,,,2023-02-01,2021-12-01,2021-12-02,ACTUAL,,,,,,,2023-02-01,2023-02-03,ACTUAL,2023-01,ESTIMATED,2023-01-31,2023-02,2023-02-28,2024-04,ESTIMATED,2024-04-30,2024-01,ESTIMATED,2024-01-31,,INTERVENTIONAL,,,Study to Evaluate the Safety and Efficacy of a Monoclonal Antibody Cocktail for the Prevention of COVID-19,"A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, and Efficacy of ADM03820 to Prevent Symptomatic COVID-19 in Adult Subjects",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,"Resilience Government Services, Inc.",,2.0,,Sponsor withdrew study prior to initiation and no participants were enrolled.,,,,,t,t,f,,,,,,,,,,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,INDUSTRY,,,,,,,2024,0.0
NCT01222559,,2010-10-15,,,2021-01-26,2010-10-15,2010-10-18,ESTIMATED,,,,,,,2021-01-26,2021-01-27,ACTUAL,2010-10,,2010-10-31,2021-01,2021-01-31,2020-02,ACTUAL,2020-02-29,2017-09,ACTUAL,2017-09-30,,INTERVENTIONAL,,,Efficacy and Safety Study of co.Don Chondrosphere to Treat Cartilage Defects,"Prospective, Randomised, Open Label, Multicentre Phase-III Clinical Trial to Compare the Efficacy and Safety of the Treatment With the Autologous Chondrocyte Transplantation Product co.Don Chondrosphere (ACT3D-CS) With Microfracture in Subjects With Cartilage Defects of the Knee With a Defect Size Between 1 an 4 cm2",COMPLETED,,PHASE3,102.0,ACTUAL,co.don AG,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,INDUSTRY,,,,,,,2020,1.0
NCT03313076,,2017-09-20,2021-04-29,,2021-07-23,2017-10-16,2017-10-18,ACTUAL,2021-07-23,2021-07-26,ACTUAL,,,,2021-07-23,2021-07-26,ACTUAL,2018-07-19,ACTUAL,2018-07-19,2021-03,2021-03-31,2020-07-31,ACTUAL,2020-07-31,2020-07-31,ACTUAL,2020-07-31,,INTERVENTIONAL,,,Vitamin D and n-3 Polyunsaturated Fatty Acids (PUFAs) to Prevent Chronic Pain Following Major Thermal Burn Injury,"Pilot, Double-blind, Randomized Controlled, Multi-center Study of the Effects of Fish Oil and Vitamin D in the Prevention of Chronic Pain Following Major Thermal Burn Injury",TERMINATED,,PHASE2,24.0,ACTUAL,"University of North Carolina, Chapel Hill",Early termination because of pandemic delays,4.0,,"COVID-19 global pandemic, and study funding period ended 7/31/2020.",f,,,,f,t,f,,,,,,12-36 months following publication,"Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC independently.",,YES,"Deidentified individual data that supports the results will be shared on request provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC) independently.",2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,OTHER,,,,,,,2020,0.0
NCT02362958,,2015-02-08,,,2020-07-13,2015-02-12,2015-02-13,ESTIMATED,,,,,,,2020-07-13,2020-07-15,ACTUAL,2015-01-09,ACTUAL,2015-01-09,2020-07,2020-07-31,2020-05-31,ACTUAL,2020-05-31,2020-05-31,ACTUAL,2020-05-31,,INTERVENTIONAL,,,A Multi-Center Study of Lapatinib in Patients With Trastuzumab-refractory Metastatic Breast Cancer,Sun Yat-sen University Cancer Center,COMPLETED,,PHASE2,159.0,ACTUAL,Sun Yat-sen University,,1.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,OTHER,,,,,,,2020,1.0
NCT03471182,,2018-02-26,2023-08-09,,2024-02-27,2018-03-13,2018-03-20,ACTUAL,2023-10-05,2023-10-06,ACTUAL,,,,2024-02-27,2024-02-29,ACTUAL,2018-02-26,ACTUAL,2018-02-26,2024-02,2024-02-29,2022-08-18,ACTUAL,2022-08-18,2022-08-18,ACTUAL,2022-08-18,,INTERVENTIONAL,,"In addition to participants enrolled in this study (N=17 CUD, N=8 HC-MRI), baseline characteristics are provided for the sample of comparison adults completing PET procedures (N=20 HC-PET) as part of other studies.",Investigation of Cocaine Addiction Using mGluR5 PET and fMRI,Investigation of Cocaine Addiction Using mGluR5 PET and fMRI,COMPLETED,,PHASE1,32.0,ACTUAL,Yale University,"This study was greatly impacted by a COVID-related suspension in research activities and subsequent restrictions on facility operations. This resulted in lower participation and study adjustments including the discontinuation of cocaine self-administration procedures, the use of historical HC-PET data, and the collection of an HC-MRI sample (no HC completed both PET and fMRI). These alterations limit the statistical power of primary outcomes and the ability to perform planned secondary analyses.",4.0,,,f,,,,f,t,f,,,,,,"In accordance with institutional standards and guidelines, after termination of this study and completion of all analysis and publications, all data and screening information will be anonymized and kept in a secure fashion for the purpose of further analyses indefinitely unless prevailing University or Federal guidelines at the time require a change.","In accordance with institutional standards and guidelines, researchers must submit a requisition form that describes their specific hypotheses and details specific data or supporting information being requested. Requests will be reviewed by senior study personnel.",,YES,"Consistent with NIH Grants Policy on Sharing of Unique Research Resources, including the Sharing of Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Grants and Contracts (December, 1999), all research resources generated will be freely distributed, as available, to appropriate, qualified academic investigators for non-commercial research purposes. All data will be de-identified before sharing, using procedures in compliance with HIPPA and Yale Human Investigation Committee standards. No available data sets or supporting information will contain subject names, addresses or other specific personal identification.",2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,OTHER,,,,,,,2022,1.0
NCT02959554,,2016-11-03,,,2021-09-07,2016-11-08,2016-11-09,ESTIMATED,,,,,,,2021-09-07,2021-09-08,ACTUAL,2016-12,ACTUAL,2016-12-31,2021-09,2021-09-30,2021-01,ACTUAL,2021-01-31,2020-08,ACTUAL,2020-08-31,,INTERVENTIONAL,NIVOSWITCH,,Study in Which Therapy is Either Switched to Nivolumab After 3 Months of Treatment or Therapy is Continued With a Tyrosine Kinase Inhibitor in Patients With Metastatic Renal Cell Carcinoma (RCC) and Disease Control,A Randomized Phase II Study With NIVOlumab or Continuation of Therapy as an Early SWITCH Approach in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) and Disease Control After 3 Months of Treatment With a Tyrosine Kinase Inhibitor,TERMINATED,,PHASE2,49.0,ACTUAL,AIO-Studien-gGmbH,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,OTHER,,,,,,,2021,0.0
NCT04541186,,2020-08-14,2024-05-08,,2024-06-30,2020-09-01,2020-09-09,ACTUAL,2024-06-30,2024-07-25,ACTUAL,,,,2024-06-30,2024-07-25,ACTUAL,2020-09-01,ACTUAL,2020-09-01,2024-06,2024-06-30,2022-05-31,ACTUAL,2022-05-31,2022-05-19,ACTUAL,2022-05-19,,INTERVENTIONAL,,"Safety Analysis Set: All participants who received at least 1 dose of study drug. Participants are summarized by treatment received.~As per SAP, since a low number of participants enrolled in the fibrate cohort, participants randomized to pegozafermin 27 mg QW fibrate cohort were combined with the pegozafermin 27 mg QW main cohort, forming a pooled pegozafermin 27 mg QW group for analyses. Similarly, the placebo participants in the fibrate cohort were combined with the main placebo group.",Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of BIO89-100 in Subjects With Severe Hypertriglyceridemia",COMPLETED,,PHASE2,86.0,ACTUAL,"89bio, Inc.",The study did not separately evaluate the response to pegozafermin in participants who were on and who were not on concurrent fibrate therapy due to small sample size in the Fibrate Expansion cohort.,5.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,INDUSTRY,,,,,,,2022,1.0
NCT02368886,,2015-02-16,2019-06-06,,2023-07-19,2015-02-20,2015-02-23,ESTIMATED,2019-07-25,2019-07-26,ACTUAL,,,,2023-07-19,2023-07-27,ACTUAL,2015-03-27,ACTUAL,2015-03-27,2022-09,2022-09-30,2023-03-02,ACTUAL,2023-03-02,2017-09-01,ACTUAL,2017-09-01,,INTERVENTIONAL,,The data for the pre-emptive and reactive treatment with clobatasol were pooled for the comparison of the two dosing strategies (regorafenib dose escalation group (Arms A1 + A2) versus regorafenib standard dose group (Arms B1 + B2)).,Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer,Regorafenib Dose Optimization Study (ReDOS): A Phase II Randomized Study of Lower Dose Regorafenib Compared to Standard Dose Regorafenib in Patients With Refractory Metastatic Colorectal Cancer (mCRC),COMPLETED,,PHASE2,123.0,ACTUAL,Academic and Community Cancer Research United,,4.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,OTHER,,,,,,,2023,1.0
NCT05144217,,2021-11-21,,,2024-09-24,2021-11-21,2021-12-03,ACTUAL,,,,,,,2024-09-24,2024-09-26,ACTUAL,2021-06-23,ACTUAL,2021-06-23,2024-09,2024-09-30,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,SILVER,,Impact of Silymarin Dosages to Decrease Drug-induced Elevated Liver Enzymes Compared to Placebo,Impact of Different Silymarin Dosages to Decrease Drug-induced Elevated Liver Enzymes Compared to Placebo in a Prospective Controlled Dose Finding Phase IIb Trial,SUSPENDED,,PHASE2/PHASE3,156.0,ESTIMATED,Fraunhofer Institute for Translational Medicine and Pharmacology ITMP,,4.0,,recruitment period has been reached its end,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,OTHER,,,,,,,2024,0.0
NCT02600429,,2015-10-26,2023-06-15,2020-06-30,2023-08-16,2015-11-06,2015-11-09,ESTIMATED,2023-07-20,2023-08-14,ACTUAL,2020-06-30,2020-07-02,ACTUAL,2023-08-16,2023-08-30,ACTUAL,2015-09-17,ACTUAL,2015-09-17,2023-07,2023-07-31,2020-03-09,ACTUAL,2020-03-09,2019-11-20,ACTUAL,2019-11-20,,INTERVENTIONAL,,\[Not Specified\],Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1,"Phase 3, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy: SEER-1",TERMINATED,,PHASE3,18.0,ACTUAL,"ReGenTree, LLC",,2.0,,Business decision,f,,,,f,,,,,,,,,,,NO,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,INDUSTRY,,,,,,,2020,0.0
NCT05420961,,2022-06-13,2024-04-04,,2024-09-10,2022-06-13,2022-06-16,ACTUAL,2024-04-04,2024-05-01,ACTUAL,,,,2024-09-10,2024-09-26,ACTUAL,2022-07-12,ACTUAL,2022-07-12,2024-09,2024-09-30,2023-05-16,ACTUAL,2023-05-16,2023-05-16,ACTUAL,2023-05-16,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)","A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older",COMPLETED,,PHASE3,717.0,ACTUAL,Merck Sharp & Dohme LLC,,5.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,INDUSTRY,,,,,,,2023,1.0
NCT04818320,,2021-03-24,,,2021-11-15,2021-03-24,2021-03-26,ACTUAL,,,,,,,2021-11-15,2021-11-24,ACTUAL,2021-02-16,ACTUAL,2021-02-16,2021-11,2021-11-30,2021-07-13,ACTUAL,2021-07-13,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,,,Favipiravir in High-risk COVID-19 Patients,"Efficacy of Favipiravir in High Risk COVID-19 Patients: A Randomised, Open-label, Multicenter Clinical Trial",COMPLETED,,PHASE3,500.0,ACTUAL,"Penang Hospital, Malaysia",,2.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,OTHER_GOV,,,,,,,2021,0.0
NCT05081388,,2021-10-14,2023-06-29,,2023-11-15,2021-10-14,2021-10-18,ACTUAL,2023-11-15,2024-04-26,ACTUAL,,,,2023-11-15,2024-04-26,ACTUAL,2021-11-08,ACTUAL,2021-11-08,2023-11,2023-11-30,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,,"COVID-19 Study to Evaluate Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Adult and Adolescent Patients Without Risk Factors for Progression to Severe Disease","A Phase 1/2/3 Adaptive Study to Evaluate the Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Patients Without Risk Factors for Progression to Severe Disease",TERMINATED,,PHASE1,25.0,ACTUAL,Regeneron Pharmaceuticals,"Due to the reduced activity of REGN14256+Imdevimab against the emerging Omicron variant and not due to any safety concerns, study enrollment was paused and later terminated in the phase 1 portion of the study. Phase 2 and phase 3 portions of the study were never opened. As a result, and due to small sample size, not all of the original objectives and endpoints were analyzed as planned",5.0,,Sponsor Decision,t,,,,t,t,f,,,,,,"When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.",Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf,https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,INDUSTRY,,NCT04617535,NO_LONGER_AVAILABLE,,,,2022,0.0
NCT02570347,,2015-10-05,,,2024-04-26,2015-10-05,2015-10-07,ESTIMATED,,,,,,,2024-04-26,2024-04-30,ACTUAL,2016-05-03,ACTUAL,2016-05-03,2024-04,2024-04-30,2020-03-31,ACTUAL,2020-03-31,2019-10-24,ACTUAL,2019-10-24,,INTERVENTIONAL,RADIANS,,Routine Antibiotic vs. Directed Antibiotic Treatment in Snake Bite,Routine vs. Clinically-Directed Antibiotic Treatment in Snake Bite With Local Envenomation: a Randomised Controlled Trial,TERMINATED,,PHASE4,66.0,ACTUAL,Jawaharlal Institute of Postgraduate Medical Education & Research,,2.0,,Slower than anticipated recruitment and emergent COVID-19 situation,f,,,,f,,,,,,,,,,,,,2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,OTHER_GOV,,,,,,,2020,0.0
NCT01817426,,2012-08-29,,,2022-03-09,2013-03-20,2013-03-25,ESTIMATED,,,,,,,2022-03-09,2022-03-24,ACTUAL,2013-01,ACTUAL,2013-01-31,2022-03,2022-03-31,2020-05,ACTUAL,2020-05-31,2020-05,ACTUAL,2020-05-31,,INTERVENTIONAL,STOP IT,,Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission,"Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission: A Multi-center, Double Blinded, Randomized, Placebo Controlled Study",COMPLETED,,PHASE4,115.0,ACTUAL,Copenhagen University Hospital at Herlev,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,OTHER,,,,,,,2020,1.0
NCT03177187,,2017-05-26,,,2024-09-24,2017-06-01,2017-06-06,ACTUAL,,,,,,,2024-09-24,2024-09-26,ACTUAL,2017-11-13,ACTUAL,2017-11-13,2023-07,2023-07-31,2022-11-16,ACTUAL,2022-11-16,2022-09-15,ACTUAL,2022-09-15,,INTERVENTIONAL,ACE,,Combination Study of AZD5069 and Enzalutamide.,"ACE: Proof of Concept Phase I/II Trial of the CXCR2 Antagonist AZD5069, Administered in Combination with Enzalutamide, in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)",TERMINATED,,PHASE1/PHASE2,30.0,ACTUAL,"Institute of Cancer Research, United Kingdom",,2.0,,Discontinuation of production of IMP,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,OTHER,,,,,,,2022,0.0
NCT03021317,,2017-01-12,2023-05-10,,2024-05-06,2017-01-12,2017-01-13,ESTIMATED,2024-05-06,2024-05-16,ACTUAL,,,,2024-05-06,2024-05-16,ACTUAL,2016-12-20,ACTUAL,2016-12-20,2024-05,2024-05-31,2020-10-07,ACTUAL,2020-10-07,2020-10-07,ACTUAL,2020-10-07,,INTERVENTIONAL,ACTHAR,No participants started the trial and received the intervention.,Effects of ACTHAR on Advanced MRI Surrogate Markers of Disease Activity and on Comprehensive Immune Signature During MS Relapses,Effects of ACTHAR on Advanced MRI Surrogate Markers of Disease Activity and on Comprehensive Immune Signature During MS Relapses,TERMINATED,,PHASE4,5.0,ACTUAL,University of Chicago,,1.0,,Terminated early due to lack of resources.,f,,,,f,,,,,,,,,,,NO,,2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,OTHER,,,,,,,2020,0.0
NCT04254679,,2020-01-30,,,2021-02-22,2020-01-31,2020-02-05,ACTUAL,,,,,,,2021-02-22,2021-02-24,ACTUAL,2020-01-29,ACTUAL,2020-01-29,2021-02,2021-02-28,2020-12-03,ACTUAL,2020-12-03,2020-09-20,ACTUAL,2020-09-20,,INTERVENTIONAL,,,Pilot Trial: Postoperative Opioid-free Analgesia,Opioid-free Analgesia After Outpatient General Surgery: A Pilot Randomized Controlled Trial,COMPLETED,,PHASE2/PHASE3,81.0,ACTUAL,McGill University Health Centre/Research Institute of the McGill University Health Centre,,2.0,,,f,,,,f,f,f,,,f,,,,,,,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,OTHER,,,,,,,2020,1.0
NCT04865419,,2021-04-26,,,2024-05-21,2021-04-26,2021-04-29,ACTUAL,,,,,,,2024-05-21,2024-05-22,ACTUAL,2021-06-11,ACTUAL,2021-06-11,2024-04,2024-04-30,2023-08-08,ACTUAL,2023-08-08,2023-08-08,ACTUAL,2023-08-08,,INTERVENTIONAL,,,Study of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies,"A Modular Phase I/II, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies",TERMINATED,,PHASE1,46.0,ACTUAL,AstraZeneca,,2.0,,Trial terminated based on benefit-risk profile assessment,,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:~https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patientlevel data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:~https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,INDUSTRY,,,,,,,2023,0.0
NCT03881111,,2019-03-18,,,2020-02-07,2019-03-18,2019-03-19,ACTUAL,,,,,,,2020-02-07,2020-02-11,ACTUAL,2019-01-21,ACTUAL,2019-01-21,2020-02,2020-02-29,2022-05-11,ESTIMATED,2022-05-11,2021-05-11,ESTIMATED,2021-05-11,,INTERVENTIONAL,,,First-line Esophageal Carcinoma Study With Chemo vs. Chemo Plus Pembrolizumab (MK-3475-590/KEYNOTE-590)-China Extension Study,"A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination With Cisplatin and 5-Fluorouracil Versus Placebo in Combination With Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects With Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)",WITHDRAWN,,PHASE3,0.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,Withdrawn due to protocol amendment,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,INDUSTRY,,,,,,,2022,0.0
NCT03324243,,2017-10-18,,,2019-01-08,2017-10-24,2017-10-27,ACTUAL,,,,,,,2019-01-08,2019-01-10,ACTUAL,2018-01,ESTIMATED,2018-01-31,2019-01,2019-01-31,2020-12,ESTIMATED,2020-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,A Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia,A Phase II Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Arog Pharmaceuticals, Inc.",,1.0,,Withdrawn: Study halted prior to enrollment of first participant,,,,,f,t,f,,,,,,,,,NO,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,INDUSTRY,,,,,,,2020,0.0
NCT03850444,,2019-02-20,2019-08-05,,2023-08-22,2019-02-20,2019-02-21,ACTUAL,2019-08-05,2019-08-26,ACTUAL,,,,2023-08-22,2023-09-18,ACTUAL,2016-08-01,ACTUAL,2016-08-01,2023-08,2023-08-31,2022-09-08,ACTUAL,2022-09-08,2018-09-04,ACTUAL,2018-09-04,,INTERVENTIONAL,,All randomized participants,Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042)-China Extension Study,"A Randomized, Open Label, Phase III Study of Overall Survival Comparing Pembrolizumab (MK-3475) Versus Platinum Based Chemotherapy in Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer (Keynote 042)",COMPLETED,,PHASE3,262.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,INDUSTRY,,,,,,,2022,1.0
NCT04106700,,2019-09-20,,,2021-02-12,2019-09-25,2019-09-27,ACTUAL,,,,,,,2021-02-12,2021-02-15,ACTUAL,2019-04-12,ACTUAL,2019-04-12,2020-06,2020-06-30,2020-10-05,ACTUAL,2020-10-05,2020-08-26,ACTUAL,2020-08-26,,INTERVENTIONAL,,,Prophylaxis With Apixaban in Transplant Eligible Patients With Multiple Myeloma Receiving Induction Therapy With IMiDs,Venous Thromboembolism Prophylaxis With Apixaban in Transplant Eligible Patients With Newly Diagnosed Multiple Myeloma Receiving Induction Therapy With an Immunomodulatory-based Regimen,TERMINATED,,PHASE2,60.0,ACTUAL,Instituto de Investigacion Sanitaria La Fe,,1.0,,Low recruitment,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 03:26:32.932486,2024-10-16 03:26:32.932486,OTHER,,,,,,,2020,0.0
NCT04252430,,2020-01-31,,,2020-05-11,2020-01-31,2020-02-05,ACTUAL,,,,,,,2020-05-11,2020-05-13,ACTUAL,2019-10-09,ACTUAL,2019-10-09,2019-10,2019-10-31,2020-03-17,ACTUAL,2020-03-17,2020-03-17,ACTUAL,2020-03-17,,INTERVENTIONAL,,,RI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Renal Impaired Patients and Healthy Subjects,"Open Label, Phase I Study to Assess and Compare the Pharmacokinetic Parameters After Single Oral Administration of MD1003 100 mg in Renal Impaired Patients and Healthy Subjects With Normal Renal Function",TERMINATED,,PHASE1,24.0,ACTUAL,MedDay Pharmaceuticals SA,,2.0,,Due to other phase 3 trial failure to meet primary endpoint,f,,,,f,f,f,,,,,,,,,,,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,INDUSTRY,,,,,,,2020,0.0
NCT05355805,,2022-04-12,2024-07-19,,2024-09-16,2022-04-28,2022-05-02,ACTUAL,2024-09-16,2024-09-25,ACTUAL,,,,2024-09-16,2024-09-25,ACTUAL,2022-05-05,ACTUAL,2022-05-05,2024-03,2024-03-31,2024-02-21,ACTUAL,2024-02-21,2023-08-02,ACTUAL,2023-08-02,,INTERVENTIONAL,,Full analysis set,Hidradenitis Suppurativa Phase 2b Study of Izokibep,A Phase 2b Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa,COMPLETED,,PHASE2,205.0,ACTUAL,ACELYRIN Inc.,,5.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,INDUSTRY,,,,,,,2024,1.0
NCT04993443,,2021-05-17,,,2023-04-11,2021-07-28,2021-08-06,ACTUAL,,,,,,,2023-04-11,2023-04-13,ACTUAL,2021-09-06,ACTUAL,2021-09-06,2021-12,2021-12-31,2023-03-09,ACTUAL,2023-03-09,2023-03-02,ACTUAL,2023-03-02,,INTERVENTIONAL,,,"First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036","A Single and Multiple-dose Escalation First-in-Human Study Evaluating the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Administered Via Inhalation and IV Infusion in Healthy Subjects and Patients With Mild Asthma.",TERMINATED,,PHASE1,40.0,ACTUAL,Syneos Health,,2.0,,"Copmeletion of Part A SAD cohorts, sponsor cancelled Part B-D cohorts",f,,,,,f,f,,,,,,,,,NO,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,OTHER,,,,,,,2023,0.0
NCT02942758,,2016-10-18,,,2024-05-07,2016-10-21,2016-10-24,ESTIMATED,,,,,,,2024-05-07,2024-05-08,ACTUAL,2017-04-10,ACTUAL,2017-04-10,2024-05,2024-05-31,2020-03-25,ACTUAL,2020-03-25,2020-03-25,ACTUAL,2020-03-25,,INTERVENTIONAL,AML-ViVA,,"Low-dose AZA, Pioglitazone, ATRA Versus Standard-dose AZA in Patients >=60 Years With Refractory AML","Randomized Phase II Trial With Safety run-in Phase Evaluating Low-dose AZA, ATRA and Pioglitazone Versus Standard Dose Azacitidine in Patients >=60 Years With AML Who Are Refractory to Standard Induction Chemotherapy",TERMINATED,,PHASE2,10.0,ACTUAL,University Hospital Regensburg,,2.0,,Due to financial reasons.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,OTHER,,,,,,,2020,0.0
NCT03339921,,2017-11-08,2024-01-17,,2024-03-04,2017-11-08,2017-11-13,ACTUAL,2024-03-04,2024-03-05,ACTUAL,,,,2024-03-04,2024-03-05,ACTUAL,2018-12-07,ACTUAL,2018-12-07,2024-03,2024-03-31,2020-05-01,ACTUAL,2020-05-01,2020-05-01,ACTUAL,2020-05-01,,INTERVENTIONAL,Botox,This study was terminated because it is unworkable.,Botulinum for Chronic Exertional Compartment Syndrome,Comparison of Botulinum Toxin to Fasciotomy in Treatment of Chronic Exertional Compartment Syndrome,TERMINATED,,PHASE2/PHASE3,3.0,ACTUAL,"375th Medical Group, Scott Air Force Base",This study was terminated because it is unworkable.,2.0,,This study is being closed because it is unworkable.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,FED,,,,,,,2020,0.0
NCT04128696,,2019-10-15,2022-04-26,,2024-06-18,2019-10-15,2019-10-16,ACTUAL,2022-04-26,2022-05-24,ACTUAL,,,,2024-06-18,2024-07-10,ACTUAL,2019-11-21,ACTUAL,2019-11-21,2024-06,2024-06-30,2023-06-20,ACTUAL,2023-06-20,2021-04-27,ACTUAL,2021-04-27,,INTERVENTIONAL,INDUCE-3,,Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma,"A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma",TERMINATED,,PHASE3,315.0,ACTUAL,GlaxoSmithKline,,2.0,,The trial was stopped by the sponsor based on assessment of the clinical data,f,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a data sharing agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,INDUSTRY,,,,,,,2023,0.0
NCT02272699,,2014-10-11,,,2021-03-16,2014-10-21,2014-10-23,ESTIMATED,,,,,,,2021-03-16,2021-03-18,ACTUAL,2014-11,,2014-11-30,2021-03,2021-03-31,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Neoadjuvant Treatment of Nimotuzumab With Chemotherapy or Radiotherapy in Resectable Esophageal Squamous Cell Carcinoma,Neoadjuvant Treatment of Nimotuzumab With Chemotherapy or Radiotherapy Versus Surgery Alone in Resectable Esophageal Squamous Cell Carcinoma,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Peking University,,3.0,,"Because there are questions about adjuvant radiotherapy in this study, the clinical trial is under re-design.",f,,,,t,,,,,,,,,,,,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,OTHER,,,,,,,2020,0.0
NCT04476043,,2020-07-15,2022-12-14,,2023-09-18,2020-07-15,2020-07-17,ACTUAL,2023-01-10,2023-01-26,ACTUAL,,,,2023-09-18,2023-09-28,ACTUAL,2020-08-25,ACTUAL,2020-08-25,2023-09,2023-09-30,2023-08-16,ACTUAL,2023-08-16,2021-12-15,ACTUAL,2021-12-15,,INTERVENTIONAL,,,To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa",COMPLETED,,PHASE2,209.0,ACTUAL,Incyte Corporation,,4.0,,,f,,,,f,t,f,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,INDUSTRY,,,,,,,2023,1.0
NCT05232227,,2021-11-18,,,2023-05-09,2022-01-29,2022-02-09,ACTUAL,,,,,,,2023-05-09,2023-05-11,ACTUAL,2023-01-20,ESTIMATED,2023-01-20,2023-05,2023-05-31,2023-10-30,ESTIMATED,2023-10-30,2023-06-05,ESTIMATED,2023-06-05,,INTERVENTIONAL,,,Primaquine Double Dose for Radical Cure of Plasmodium Vivax in Colombia,Primaquine Double Dose for Radical Cure of Plasmodium Vivax in Colombia,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,"University of California, San Francisco",,2.0,,Trial terminated by funder,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,OTHER,,,,,,,2023,0.0
NCT03781960,,2018-12-17,2022-10-21,,2022-11-17,2018-12-18,2018-12-20,ACTUAL,2022-11-17,2022-12-14,ACTUAL,,,,2022-11-17,2022-12-14,ACTUAL,2019-07-31,ACTUAL,2019-07-31,2022-11,2022-11-30,2022-04-29,ACTUAL,2022-04-29,2022-04-29,ACTUAL,2022-04-29,,INTERVENTIONAL,,,Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma,Phase II Trial of Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma,TERMINATED,,PHASE2,7.0,ACTUAL,Abramson Cancer Center at Penn Medicine,Early termination leading to small numbers of subjects analyzed,1.0,,Safety letter from sponsor,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,OTHER,,,,,,,2022,0.0
NCT03634488,,2018-01-30,2023-10-06,,2024-02-29,2018-08-14,2018-08-16,ACTUAL,2024-02-29,2024-03-27,ACTUAL,,,,2024-02-29,2024-03-27,ACTUAL,2021-08-18,ACTUAL,2021-08-18,2024-02,2024-02-29,2022-11-09,ACTUAL,2022-11-09,2022-10-05,ACTUAL,2022-10-05,,INTERVENTIONAL,,Baseline characteristics of participants with sickle cell anemia and severe acute malnutrition by randomization status in the SAMS trial. Baseline characteristics of non-SCD siblings with sickle cell anemia and severe acute malnutrition by randomization status in the SAMS trial.,"Management of Severe Acute Malnutrition in SCD, in Northern Nigeria",Management of Severe Acute Malnutrition in Children With Sickle Cell Disease Greater Than 5 Years of Age Living in Northern Nigeria,COMPLETED,,PHASE2,132.0,ACTUAL,Vanderbilt University Medical Center,"The sample size for this feasibility study was not determined with the goal of assessing differences in efficacy between the treatment arms. As a feasibility study, the sample size was not based on determining the difference in efficacy of the 2 treatment arms.",3.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,OTHER,,,,,,,2022,1.0
NCT03971357,,2019-05-30,2023-01-06,,2023-02-01,2019-05-30,2019-06-03,ACTUAL,2023-02-01,2023-02-06,ACTUAL,,,,2023-02-01,2023-02-06,ACTUAL,2019-07-22,ACTUAL,2019-07-22,2021-08,2021-08-31,2021-08-26,ACTUAL,2021-08-26,2021-08-26,ACTUAL,2021-08-26,,INTERVENTIONAL,,,Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration,Prospective Randomized Study to Determine Whether Use of Rhopressa™ Accelerates Corneal Clearing After Removal of Descemet Membrane for Treatment of Fuchs Dystrophy,TERMINATED,,PHASE2/PHASE3,19.0,ACTUAL,Price Vision Group,,2.0,,variance of outcome measures was substantially greater than anticipated in the statistical plan,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,INDUSTRY,,,,,,,2021,0.0
NCT03603496,,2018-07-18,2022-02-24,,2022-05-03,2018-07-18,2018-07-27,ACTUAL,2022-05-03,2022-05-05,ACTUAL,,,,2022-05-03,2022-05-05,ACTUAL,2018-09-01,ACTUAL,2018-09-01,2022-05,2022-05-31,2020-11-17,ACTUAL,2020-11-17,2020-11-17,ACTUAL,2020-11-17,,INTERVENTIONAL,HH4,,Post-Discharge Smoking Cessation Strategies: Helping HAND 4,Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers,COMPLETED,,PHASE4,1416.0,ACTUAL,Massachusetts General Hospital,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,OTHER,,,,,,,2020,1.0
NCT02918864,,2016-09-09,2023-11-09,2022-09-29,2024-04-03,2016-09-27,2016-09-29,ESTIMATED,2024-04-03,2024-04-05,ACTUAL,2022-10-28,2022-11-04,ACTUAL,2024-04-03,2024-04-05,ACTUAL,2016-06-15,ACTUAL,2016-06-15,2024-04,2024-04-30,2021-09,ACTUAL,2021-09-30,2021-09,ACTUAL,2021-09-30,,INTERVENTIONAL,ION-ASD,,Oxytocin and Social Cognitive Skills Groups,"Integrated Oxytocin and Nonverbal, Emotion Recognition, and Theory of Mind Training for Children With Autism Spectrum Disorder",COMPLETED,,PHASE2,40.0,ACTUAL,Rush University Medical Center,"Enrollment was slowed down during COVID-19 shut down resulting in the study being under-powered and some groups receiving modified protocols. Apriori secondary analyses of maintenance effects resulted in multiple comparisons tests (i.e., at week 16 and 24) which were not corrected to balance type I/type II errors. Additionally, social cognitive stimuli were not counterbalanced; thus, it's unclear whether social cognitive improvements across groups reflect learning or practice effects.",2.0,,,f,,,,t,,,,,,,,,,,YES,"Data from this study may be submitted to the National Database for Autism Research (NDAR), a computer system run by the National Institutes of Health that allows researchers studying autism to collect and share information. Data will be shared with study collaborators as well.",2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,OTHER,,,,,,,2021,1.0
NCT02900352,,2016-09-09,2022-04-22,,2022-10-10,2016-09-09,2016-09-14,ESTIMATED,2022-10-10,2022-10-13,ACTUAL,,,,2022-10-10,2022-10-13,ACTUAL,2016-10,,2016-10-31,2022-10,2022-10-31,2021-04-22,ACTUAL,2021-04-22,2021-04-22,ACTUAL,2021-04-22,,INTERVENTIONAL,Z-Comp,Alcohol Use Disorder Treatment Seekers,Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action,Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action,COMPLETED,,PHASE3,156.0,ACTUAL,Virginia Commonwealth University,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,OTHER,,,,,,,2021,1.0
NCT04530344,,2020-08-25,2023-05-25,,2023-06-28,2020-08-25,2020-08-28,ACTUAL,2023-06-28,2023-07-19,ACTUAL,,,,2023-06-28,2023-07-19,ACTUAL,2020-09-24,ACTUAL,2020-09-24,2023-06,2023-06-30,2022-11-14,ACTUAL,2022-11-14,2022-11-14,ACTUAL,2022-11-14,,INTERVENTIONAL,,,Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo,"A Double-Blind, Vehicle-Controlled, Randomized Withdrawal and Treatment Extension Study to Assess the Long-Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo",COMPLETED,,PHASE3,458.0,ACTUAL,Incyte Corporation,Data from participants at a single site (N = 2) were removed from all efficacy analyses performed on the ITT-Ext Population and FAS Cohort A owing to noncompliance with the Protocol in the parent study resulting in serious concerns with data quality.,3.0,,,f,,,,f,t,f,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,INDUSTRY,,,,,,,2022,1.0
NCT02899611,,2016-09-03,,,2023-03-14,2016-09-08,2016-09-14,ESTIMATED,,,,,,,2023-03-14,2023-03-16,ACTUAL,2016-08,ACTUAL,2016-08-31,2023-03,2023-03-31,2021-06-01,ACTUAL,2021-06-01,2021-06-01,ACTUAL,2021-06-01,,INTERVENTIONAL,,,A Dose Ranging Pilot Study for Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Temporal Seizures,"A Dose Ranging Pilot Study to Assess Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Focal Seizures, With Temporal Lobe Onset With or Without Secondary Generalization",COMPLETED,,PHASE1/PHASE2,6.0,ACTUAL,Cerebral Therapeutics LLC,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,INDUSTRY,,,,,,,2021,1.0
NCT04858620,,2021-02-04,,,2023-10-12,2021-04-22,2021-04-26,ACTUAL,,,,,,,2023-10-12,2023-10-16,ACTUAL,2020-08-30,ACTUAL,2020-08-30,2023-10,2023-10-31,2021-08-30,ESTIMATED,2021-08-30,2021-08-30,ESTIMATED,2021-08-30,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection,A Randomized Placebo Control Trial to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection,WITHDRAWN,,PHASE3,0.0,ACTUAL,Larkin Community Hospital,,3.0,,Study Period Ended / Not Completed,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,OTHER,,,,,,,2021,0.0
NCT04804254,,2021-03-16,,,2023-02-02,2021-03-16,2021-03-18,ACTUAL,,,,,,,2023-02-02,2023-02-03,ACTUAL,2021-04-27,ACTUAL,2021-04-27,2023-01,2023-01-31,2023-01-11,ACTUAL,2023-01-11,2023-01-11,ACTUAL,2023-01-11,,INTERVENTIONAL,,,"Study to Evaluate Adverse Events, Change in Disease Activity, Movement of Oral ABBV-623 and ABBV-992 Tablets in the Body of Adult Participants With B-cell Cancers","A Phase 1 First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of ABBV-623 and ABBV-992 in Subjects With B-cell Malignancies",TERMINATED,,PHASE1,5.0,ACTUAL,AbbVie,,6.0,,Strategic considerations,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,INDUSTRY,,,,,,,2023,0.0
NCT03048422,,2017-02-07,2021-10-04,,2022-10-28,2017-02-07,2017-02-09,ESTIMATED,2021-10-12,2021-11-10,ACTUAL,,,,2022-10-28,2022-11-21,ACTUAL,2018-01-19,ACTUAL,2018-01-19,2022-10,2022-10-31,2020-10-03,ACTUAL,2020-10-03,2020-10-03,ACTUAL,2020-10-03,,INTERVENTIONAL,VESTED,Enrolled women.,Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants,Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants,COMPLETED,,PHASE3,643.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,6.0,,,f,,,,t,t,f,,,,,,Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH,* With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.~* For what types of analyses? To achieve aims in the proposal approved by the IMPAACT Network.~* By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT Data Request form at: https://www.impaactnetwork.org/studies/submit-research-proposal. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.,https://www.impaactnetwork.org/studies/submit-research-proposal,YES,"Individual participant data that underlie results in the publication, after deidentification",2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,NIH,,,,,,,2020,1.0
NCT04610684,,2020-10-26,2024-01-02,,2024-02-15,2020-10-26,2020-10-30,ACTUAL,2024-02-15,2024-03-13,ACTUAL,,,,2024-02-15,2024-03-13,ACTUAL,2021-01-05,ACTUAL,2021-01-05,2024-02,2024-02-29,2022-09-20,ACTUAL,2022-09-20,2022-07-15,ACTUAL,2022-07-15,,INTERVENTIONAL,,,"Chemotherapy and Atezolizumab for Patients With Extensive Stage Small Cell Lung Cancer (SCLC) With Untreated, Asymptomatic Brain Metastases","Chemotherapy and Atezolizumab for Patients With Extensive Stage Small Cell Lung Cancer (SCLC) With Untreated, Asymptomatic Brain Metastases",TERMINATED,,PHASE2,3.0,ACTUAL,Hoosier Cancer Research Network,,1.0,,Lack of Enrollment,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,OTHER,,,,,,,2022,0.0
NCT04789408,,2021-03-05,,,2024-06-07,2021-03-05,2021-03-09,ACTUAL,,,,,,,2024-06-07,2024-06-10,ACTUAL,2021-07-19,ACTUAL,2021-07-19,2024-06,2024-06-30,2024-05-18,ACTUAL,2024-05-18,2024-05-18,ACTUAL,2024-05-18,,INTERVENTIONAL,,,Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia,"A Phase 1 Open-label, Multicenter Study Evaluating the Safety of KITE-222, an Autologous Anti-CLL-1 CAR T-cell Therapy, in Subjects With Relapsed/Refractory Acute Myeloid Leukemia",TERMINATED,,PHASE1,15.0,ACTUAL,Gilead Sciences,,1.0,,Study was terminated due to futility,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,INDUSTRY,,,,,,,2024,0.0
NCT01924533,,2013-08-14,2017-02-27,,2024-03-21,2013-08-14,2013-08-16,ESTIMATED,2018-11-05,2018-11-07,ACTUAL,,,,2024-03-21,2024-03-22,ACTUAL,2013-09-03,ACTUAL,2013-09-03,2024-03,2024-03-31,2023-03-27,ACTUAL,2023-03-27,2016-04-04,ACTUAL,2016-04-04,,INTERVENTIONAL,,,Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.,"A Randomized, Double-blinded, Placebo Controlled, Multicentre Phase III Study to Assess the Efficacy and Safety of Olaparib (AZD2281) in Combination With Paclitaxel, Compared to Placebo in Combination With Paclitaxel, in Asian Patients With Advanced Gastric Cancer (Including the Gastro-oesophageal Junction) Who Have Progressed Following First Line Therapy",COMPLETED,,PHASE3,525.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,,,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,INDUSTRY,,,,,,,2023,1.0
NCT04155424,,2019-11-05,2024-07-29,,2024-09-19,2019-11-05,2019-11-07,ACTUAL,2024-09-19,2024-09-25,ACTUAL,,,,2024-09-19,2024-09-25,ACTUAL,2020-01-14,ACTUAL,2020-01-14,2024-09,2024-09-30,2023-07-31,ACTUAL,2023-07-31,2023-07-31,ACTUAL,2023-07-31,,INTERVENTIONAL,,Safety Set included all participants who received at least 1 dose of eculizumab.,A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder,"A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients With Relapsing Neuromyelitis Optica Spectrum Disorder",TERMINATED,,PHASE2/PHASE3,5.0,ACTUAL,"Alexion Pharmaceuticals, Inc.","The study was terminated by Alexion, as only 5 of the planned 12 participants were enrolled due to difficulty in recruitment.",1.0,,Pediatric clinical study is not feasible.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,INDUSTRY,,,,,,,2023,0.0
NCT03159936,,2017-05-02,,,2022-01-06,2017-05-18,2017-05-19,ACTUAL,,,,,,,2022-01-06,2022-01-21,ACTUAL,2017-04-03,ACTUAL,2017-04-03,2022-01,2022-01-31,2020-06-10,ACTUAL,2020-06-10,2020-05-13,ACTUAL,2020-05-13,,INTERVENTIONAL,,,Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE),Open Label Phase 2 Pilot Trial of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE),TERMINATED,,EARLY_PHASE1,5.0,ACTUAL,Tufts Medical Center,,1.0,,unable to identify additional subjects to qualify for enrollment,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,OTHER,,,,,,,2020,0.0
NCT04653194,,2020-11-27,,,2024-02-07,2020-11-27,2020-12-04,ACTUAL,,,,,,,2024-02-07,2024-02-08,ACTUAL,2020-09-30,ACTUAL,2020-09-30,2024-01,2024-01-31,2023-07-31,ACTUAL,2023-07-31,2023-07-30,ACTUAL,2023-07-30,,INTERVENTIONAL,BIC-T&T,,Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat',Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat',COMPLETED,,PHASE3,36.0,ACTUAL,Chelsea and Westminster NHS Foundation Trust,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,OTHER,,,,,,,2023,1.0
NCT04730947,,2021-01-27,2023-09-20,,2023-09-20,2021-01-27,2021-01-29,ACTUAL,2023-09-20,2023-10-12,ACTUAL,,,,2023-09-20,2023-10-12,ACTUAL,2021-02-24,ACTUAL,2021-02-24,2023-09,2023-09-30,2022-11-17,ACTUAL,2022-11-17,2022-11-17,ACTUAL,2022-11-17,,INTERVENTIONAL,,,Dapagliflozin (DAPA) Effects in HFpEF,"Evaluation of the Cardiac and Metabolic Effects of Dapagliflozin in Heart Failure With Preserved Ejection Fraction (CAMEO-DAPA): A Phase II, Prospective, Double-Blind Study",COMPLETED,,PHASE2,38.0,ACTUAL,Mayo Clinic,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,OTHER,,,,,,,2022,1.0
NCT04176913,,2019-11-18,,,2021-12-17,2019-11-22,2019-11-25,ACTUAL,,,,,,,2021-12-17,2022-01-10,ACTUAL,2020-12-01,ACTUAL,2020-12-01,2021-12,2021-12-31,2021-12-09,ACTUAL,2021-12-09,2021-12-09,ACTUAL,2021-12-09,,INTERVENTIONAL,,,Study of LUCAR-20S in Patients With R/R NHL,"A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of LUCAR-20S in Patients With Relapsed/Refractory Diffuse Large B-Cell, Follicular, Mantle Cell or Small Lymphocytic Lymphoma",TERMINATED,,PHASE1,7.0,ACTUAL,The First Affiliated Hospital with Nanjing Medical University,,1.0,,Both the sponsors and collaborator are considering terminating the study,f,,,,,f,f,,,,,,,,,,,2024-10-17 01:30:47.04044,2024-10-17 01:30:47.04044,OTHER,,,,,,,2021,0.0
NCT04318444,,2020-03-20,2022-03-31,,2024-08-29,2020-03-20,2020-03-24,ACTUAL,2024-08-29,2024-09-25,ACTUAL,,,,2024-08-29,2024-09-25,ACTUAL,2020-03-29,ACTUAL,2020-03-29,2024-08,2024-08-31,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,,"2 out of 10 consented participants withdrew consent prior to initiating study intervention.~Due to the low number of participants per group, baseline characteristics are presented as one arm to protect the confidentiality of the participants.",Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19),Hydroxychloroquine Post Exposure Prophylaxis (PEP) for Household Contacts of COVID-19 Patients: A NYC Community-Based Randomized Clinical Trial,TERMINATED,,PHASE2/PHASE3,10.0,ACTUAL,Columbia University,,2.0,,The Institutional Review Board closed the study,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,OTHER,,,,,,,2021,0.0
NCT04843319,,2021-04-09,,,2023-05-17,2021-04-09,2021-04-13,ACTUAL,,,,,,,2023-05-17,2023-05-19,ACTUAL,2021-06-09,ACTUAL,2021-06-09,2023-05,2023-05-31,2023-01-19,ACTUAL,2023-01-19,2023-01-19,ACTUAL,2023-01-19,,INTERVENTIONAL,VERU-100,,To Determine an Effective Dose of VERU-100 for the Treatment of Advanced Prostate Cancer,"Open-Label, Proof-of-Concept and Dose Finding Phase 1b/2 Study of VERU-100 in Men With Advanced Prostate Cancer",TERMINATED,,PHASE1/PHASE2,24.0,ACTUAL,Veru Inc.,,1.0,,Study terminated as end points were not achieved at current dose level.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 16:37:10.012151,2024-10-15 16:37:10.012151,INDUSTRY,,,,,,,2023,0.0
NCT04649515,,2020-11-26,,,2022-03-08,2020-11-30,2020-12-02,ACTUAL,,,,,,,2022-03-08,2022-03-24,ACTUAL,2020-12-04,ACTUAL,2020-12-04,2022-03,2022-03-31,2022-03-04,ACTUAL,2022-03-04,2022-03-04,ACTUAL,2022-03-04,,INTERVENTIONAL,,,"Efficacy and Safety of TY027, a Treatment for COVID-19, in Humans","Phase 3 Multi-Site, Randomised, Placebo Controlled, Double Blind, Single Dose Study of TY027 for Early Treatment of COVID-19",TERMINATED,,PHASE3,17.0,ACTUAL,Tychan Pte Ltd.,,3.0,,Low recruitment rate,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,INDUSTRY,,,,,,,2022,0.0
NCT04974359,,2021-06-28,,,2022-01-28,2021-07-13,2021-07-23,ACTUAL,,,,,,,2022-01-28,2022-02-11,ACTUAL,2021-06-24,ACTUAL,2021-06-24,2022-01,2022-01-31,2022-01-26,ACTUAL,2022-01-26,2022-01-26,ACTUAL,2022-01-26,,INTERVENTIONAL,,,A Study to Evaluate Lu AG06466 in Participants With Fibromyalgia,"Interventional, Randomized, Double-Blind, Crossover, Placebo-Controlled, Multiple-Dose Lu AG06466 Phase IB Study in Patients With Fibromyalgia Using Neuroimaging to Investigate Its Pharmacodynamic Effects on Central Pain Processing and Neuroinflammation",TERMINATED,,PHASE1,3.0,ACTUAL,H. Lundbeck A/S,,2.0,,Study terminated due to enrolment challenges.,f,,,,,t,f,,,,,,,,,,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,INDUSTRY,,,,,,,2022,0.0
NCT03777059,,2018-12-13,2021-06-18,,2021-06-18,2018-12-13,2018-12-17,ACTUAL,2021-06-18,2021-07-09,ACTUAL,,,,2021-06-18,2021-07-09,ACTUAL,2018-12-14,ACTUAL,2018-12-14,2021-06,2021-06-30,2020-06-19,ACTUAL,2020-06-19,2020-06-19,ACTUAL,2020-06-19,,INTERVENTIONAL,,Safety Population included all participants who received at least 1 dose of study intervention.,12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine,"A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine (ADVANCE)",COMPLETED,,PHASE3,910.0,ACTUAL,Allergan,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,INDUSTRY,,,,,,,2020,1.0
NCT03793712,,2019-01-03,,,2020-09-21,2019-01-03,2019-01-04,ACTUAL,,,,,,,2020-09-21,2020-09-23,ACTUAL,2018-12-27,ACTUAL,2018-12-27,2020-09,2020-09-30,2020-09-03,ACTUAL,2020-09-03,2020-08-20,ACTUAL,2020-08-20,,INTERVENTIONAL,,,Study With Lu AF11167 for the Treatment of Negative Symptoms in Patients With Schizophrenia,"Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-flexible-dose Study of Lu AF11167 for the Treatment of Persistent Prominent Negative Symptoms in Patients With Schizophrenia",TERMINATED,,PHASE2,168.0,ACTUAL,H. Lundbeck A/S,,3.0,,Lack of efficacy based on interim analysis,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,INDUSTRY,,,,,,,2020,0.0
NCT01997840,,2013-11-20,,,2024-07-29,2013-11-25,2013-11-28,ESTIMATED,,,,,,,2024-07-29,2024-07-31,ACTUAL,2014-03-01,ACTUAL,2014-03-01,2024-07,2024-07-31,2024-02-29,ACTUAL,2024-02-29,2024-02-29,ACTUAL,2024-02-29,,INTERVENTIONAL,,,ACY-1215 (Ricolinostat) in Combination With Pomalidomide and Low-dose Dex in Relapsed-and-Refractory Multiple Myeloma,"A Phase 1B/2 Multi-Center, Open Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of ACY-1215 (RICOLINOSTAT) in Combination With Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma",TERMINATED,,PHASE1/PHASE2,103.0,ACTUAL,Celgene,,1.0,,Lack of efficacy,f,,,,f,,,,,,,,,,,,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,INDUSTRY,,,,,,,2024,0.0
NCT04443569,,2020-06-19,2023-08-25,,2023-09-21,2020-06-19,2020-06-23,ACTUAL,2023-09-21,2023-10-10,ACTUAL,,,,2023-09-21,2023-10-10,ACTUAL,2021-10-10,ACTUAL,2021-10-10,2023-09,2023-09-30,2022-08-31,ACTUAL,2022-08-31,2022-08-31,ACTUAL,2022-08-31,,INTERVENTIONAL,LPACS,,Lidocaine Patches After Cesarean Section,Lidocaine Patches After Cesarean Section,COMPLETED,,PHASE3,93.0,ACTUAL,Yale University,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,OTHER,,,,,,,2022,1.0
NCT06049329,,2023-09-11,,,2024-03-01,2023-09-19,2023-09-22,ACTUAL,,,,,,,2024-03-01,2024-03-04,ACTUAL,2023-09-14,ACTUAL,2023-09-14,2024-03,2024-03-31,2023-12-15,ACTUAL,2023-12-15,2023-12-15,ACTUAL,2023-12-15,,INTERVENTIONAL,,,"A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity","Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0487-0111 in Japanese Participants With Obesity",COMPLETED,,PHASE1,36.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,f,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,INDUSTRY,,,,,,,2023,1.0
NCT03952481,,2019-05-10,,,2021-02-10,2019-05-14,2019-05-16,ACTUAL,,,,,,,2021-02-10,2021-02-16,ACTUAL,2021-03-01,ESTIMATED,2021-03-01,2021-02,2021-02-28,2021-12-31,ESTIMATED,2021-12-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Effect of Lifitegrast 5% on Tear Film Markers,Improvement in Markers of Tear Film Instability After Initiation of Lifitegrast 5% Ophthalmic Solution: A Prospective Interventional Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,Weill Medical College of Cornell University,,1.0,,COVID restrictions,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,OTHER,,,,,,,2021,0.0
NCT04161118,,2019-11-08,,,2023-05-02,2019-11-12,2019-11-13,ACTUAL,,,,,,,2023-05-02,2023-05-06,ACTUAL,2021-05-12,ACTUAL,2021-05-12,2023-05,2023-05-31,2023-02-24,ACTUAL,2023-02-24,2023-02-24,ACTUAL,2023-02-24,,INTERVENTIONAL,TIGER-CTL019,,TisaGenlecleucel in Elderly Patients With First-Relapsed or Primary Refractory Aggressive B-cell Non-Hodgkin Lymphoma,Phase II Trial of TisaGenlecleucel in Elderly Patients With First-Relapsed or Primary Refractory Aggressive B-cell Non-Hodgkin Lymphoma,TERMINATED,,PHASE2,3.0,ACTUAL,University of Cologne,,1.0,,"Termination of the funding agreement by the financial sponsor of the study. Small number of patients enrolled, none of the planned analyses will be feasible to draw conclusions on the safety or efficacy of the therapy.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,OTHER,,,,,,,2023,0.0
NCT02397889,,2015-03-19,2021-01-25,,2021-02-16,2015-03-19,2015-03-25,ESTIMATED,2021-01-25,2021-02-11,ACTUAL,,,,2021-02-16,2021-03-11,ACTUAL,2015-05-18,,2015-05-18,2021-02,2021-02-28,2020-01-27,ACTUAL,2020-01-27,2020-01-27,ACTUAL,2020-01-27,,INTERVENTIONAL,,,Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD),Randomized Controlled Trial of Repeated-Dose Intravenous Ketamine for PTSD,COMPLETED,,PHASE2/PHASE3,30.0,ACTUAL,Icahn School of Medicine at Mount Sinai,"Exclusion of patients with comorbid psychotic, bipolar, or current alcohol or substance use disorders to protect against worsening of psychotic symptoms or abuse potential, which may limit generalizability of our findings to individuals with PTSD and these comorbid disorders.",2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,OTHER,,,,,,,2020,1.0
NCT04962022,,2021-07-10,2022-08-11,,2022-08-11,2021-07-10,2021-07-14,ACTUAL,2022-08-11,2023-07-13,ACTUAL,,,,2022-08-11,2023-07-13,ACTUAL,2021-07-20,ACTUAL,2021-07-20,2022-08,2022-08-31,2021-09-30,ACTUAL,2021-09-30,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,,The baseline analysis population included all participants enrolled in the study.,Drug-Drug Interaction Study Assessing Effect of Itraconazole on PF-07321332/Ritonavir in Healthy Participants,"COVID-19: A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD CROSSOVER STUDY TO ESTIMATE THE EFFECT OF ITRACONAZOLE ON THE PHARMACOKINETICS OF PF-07321332/RITONAVIR IN HEALTHY PARTICIPANTS",COMPLETED,,PHASE1,12.0,ACTUAL,Pfizer,,2.0,,,f,,,,,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,INDUSTRY,,,,,,,2021,1.0
NCT05484011,,2022-07-15,,,2024-04-08,2022-07-29,2022-08-02,ACTUAL,,,,,,,2024-04-08,2024-04-10,ACTUAL,2022-12-15,ACTUAL,2022-12-15,2023-09,2023-09-30,2024-03-04,ACTUAL,2024-03-04,2024-03-04,ACTUAL,2024-03-04,,INTERVENTIONAL,,,A Maintenance Therapy Study of Odetiglucan With CDX-1140 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma,"P1b, Open-Label, Safety, Tolerability, Efficacy Study of a Soluble Beta-glucan Odetiglucan in Combination w/ a CD40 Agonist (CDX-1140) in Patients w/ Metastatic Pancreatic Adenocarcinoma Whose Disease Did Not Progress During 1st-Line Chemo",TERMINATED,,PHASE1,5.0,ACTUAL,"HiberCell, Inc.",,2.0,,sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,INDUSTRY,,,,,,,2024,0.0
NCT03178201,,2017-06-01,2021-06-28,,2021-06-28,2017-06-05,2017-06-06,ACTUAL,2021-06-28,2021-07-16,ACTUAL,,,,2021-06-28,2021-07-16,ACTUAL,2017-08-20,ACTUAL,2017-08-20,2021-06,2021-06-30,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,TGR1202 in Relapsed and Refractory Follicular Lymphoma,Study of the Phosphoinositide-3-Kinase-Delta Inhibitor TGR-1202 in Patients With Relapsed or Refractory Follicular Lymphoma,TERMINATED,,PHASE2,5.0,ACTUAL,Columbia University,,1.0,,PI left institution,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,OTHER,,,,,,,2020,0.0
NCT04942054,,2021-06-11,,,2023-05-19,2021-06-18,2021-06-28,ACTUAL,,,,,,,2023-05-19,2023-05-22,ACTUAL,2022-05-20,ACTUAL,2022-05-20,2023-05,2023-05-31,2023-02-28,ACTUAL,2023-02-28,2023-02-28,ACTUAL,2023-02-28,,INTERVENTIONAL,,,A Study in Patients With Advanced Breast Cancer,"A Phase 1 Study to Determine Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of SCO-120 in Hormone Receptor Positive, HER-2 Negative Advanced Breast Cancer Patients",TERMINATED,,PHASE1,9.0,ACTUAL,Sun Pharma Advanced Research Company Limited,,1.0,,The decision to close is due commercial reasons only,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,INDUSTRY,,,,,,,2023,0.0
NCT02586623,,2015-10-23,2023-07-20,,2023-08-21,2015-10-23,2015-10-26,ESTIMATED,2023-08-21,2023-08-23,ACTUAL,,,,2023-08-21,2023-08-23,ACTUAL,2016-02-11,ACTUAL,2016-02-11,2023-08,2023-08-31,2022-09-09,ACTUAL,2022-09-09,2022-07-21,ACTUAL,2022-07-21,,INTERVENTIONAL,RESTORE,"The Safety Set (open-label droxidopa) included all participants who received at least one dose of Investigational Medicinal Product (IMP). The Full Analysis Set (double-blind droxidopa, double-blind placebo) included all randomized patients who took at least one dose of IMP in the double-blind period.",Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension,RESTORE: A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy,COMPLETED,,PHASE4,453.0,ACTUAL,H. Lundbeck A/S,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,INDUSTRY,,,,,,,2022,1.0
NCT03924323,,2019-04-19,2022-09-20,,2022-10-21,2019-04-19,2019-04-23,ACTUAL,2022-10-21,2022-11-14,ACTUAL,,,,2022-10-21,2022-11-14,ACTUAL,2019-05-30,ACTUAL,2019-05-30,2022-10,2022-10-31,2021-09-20,ACTUAL,2021-09-20,2021-09-20,ACTUAL,2021-09-20,,INTERVENTIONAL,,The Safety Population consisted of all subjects in the Randomized Population who took at least 1 dose of study medication.,A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder,"A Randomized, Multicenter, Double-Blind, Flexibly-dosed, Efficacy and Safety Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder",COMPLETED,,PHASE4,273.0,ACTUAL,AbbVie,,2.0,,,f,,,,f,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,INDUSTRY,,,,,,,2021,1.0
NCT02256696,,2014-09-25,2023-05-01,,2023-06-26,2014-10-01,2014-10-06,ESTIMATED,2023-06-26,2023-07-18,ACTUAL,,,,2023-06-26,2023-07-18,ACTUAL,2015-04-29,ACTUAL,2015-04-29,2023-05,2023-05-31,2022-05-01,ACTUAL,2022-05-01,2022-05-01,ACTUAL,2022-05-01,,INTERVENTIONAL,,,Assessing PA-824 for Tuberculosis (the APT Trial),"A Phase 2 Randomized, Open-Label Trial of PA-824-Containing Regimens Versus Standard Treatment for Drug-Sensitive Sputum Smear-Positive Pulmonary Tuberculosis",COMPLETED,,PHASE2,157.0,ACTUAL,Johns Hopkins University,,3.0,,,f,,,,t,t,f,,,,,,Within one year of reaching recruitment goals.,"This plan is in process, to be finalized prior to the end of recruitment.",,YES,"This plan is in process, to be finalized prior to the end of recruitment.",2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,OTHER,,,,,,,2022,1.0
NCT03335774,,2017-10-30,2022-04-27,,2022-08-18,2017-11-03,2017-11-08,ACTUAL,2022-08-18,2022-09-13,ACTUAL,,,,2022-08-18,2022-09-13,ACTUAL,2019-02-12,ACTUAL,2019-02-12,2022-08,2022-08-31,2021-03-05,ACTUAL,2021-03-05,2021-03-05,ACTUAL,2021-03-05,,INTERVENTIONAL,,,Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids,"A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in the Treatment of Symptomatic Internal Hemorrhoids.",COMPLETED,,PHASE2,103.0,ACTUAL,Nivagen Pharmaceuticals Inc.,,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,INDUSTRY,,,,,,,2021,1.0
NCT04270461,,2020-02-10,,,2020-10-18,2020-02-13,2020-02-17,ACTUAL,,,,,,,2020-10-18,2020-10-22,ACTUAL,2020-03-17,ACTUAL,2020-03-17,2020-10,2020-10-31,2020-10-17,ACTUAL,2020-10-17,2020-10-17,ACTUAL,2020-10-17,,INTERVENTIONAL,,,NKG2D-based CAR T-cells Immunotherapy for Patient With r/r NKG2DL+ Solid Tumors,A Phase I Clinical Trial of NKG2D-based CAR T-cells Injection for Subjects With Relapsed/Refractory NKG2DL+ Solid Tumors,WITHDRAWN,,PHASE1,0.0,ACTUAL,Jiujiang University Affiliated Hospital,,1.0,,Study is withdrawn because of administrative reasons,f,,,,,f,f,,,,,,,,,NO,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,OTHER_GOV,,,,,,,2020,0.0
NCT03852719,,2019-02-21,2022-10-03,2021-11-12,2024-08-13,2019-02-21,2019-02-25,ACTUAL,2022-10-03,2022-10-28,ACTUAL,2021-11-12,2021-11-17,ACTUAL,2024-08-13,2024-08-16,ACTUAL,2019-04-17,ACTUAL,2019-04-17,2024-08,2024-08-31,2024-08-08,ACTUAL,2024-08-08,2020-11-26,ACTUAL,2020-11-26,,INTERVENTIONAL,,The Full Analysis Set (FAS) includes all participants who were randomized to Bulevirtide (BLV) and took at least 1 dose of BLV or randomized to delayed treatment group.,Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD),"A Multicenter, Open-label, Randomized Phase 3 Clinical Study to Assess Efficacy and Safety of Bulevirtide in Patients With Chronic Hepatitis Delta",COMPLETED,,PHASE3,150.0,ACTUAL,Gilead Sciences,,3.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,INDUSTRY,,,,,,,2024,1.0
NCT04339816,,2020-04-06,,,2020-11-05,2020-04-06,2020-04-09,ACTUAL,,,,,,,2020-11-05,2020-11-06,ACTUAL,2020-05-13,ACTUAL,2020-05-13,2020-11,2020-11-30,2020-11-04,ACTUAL,2020-11-04,2020-11-04,ACTUAL,2020-11-04,,INTERVENTIONAL,AZIQUINE-ICU,,Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care With COVID-19: Randomised Controlled Trial,Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care Due to Coronavirus Disease 2019 (COVID-19)- Randomised Controlled Trial,TERMINATED,,PHASE3,3.0,ACTUAL,"Charles University, Czech Republic",,3.0,,Steering Committee decision in accordance with stopping rule 1: Emergence of new data,f,,,,f,f,f,,,,,,within 6 months of study completion,,http://mendeley.com,YES,Deidentified record-level data will be shared in a public database,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,OTHER,,,,,,,2020,0.0
NCT04449588,,2020-06-26,,,2024-05-20,2020-06-26,2020-06-29,ACTUAL,,,,,,,2024-05-20,2024-05-22,ACTUAL,2020-07-23,ACTUAL,2020-07-23,2024-05,2024-05-31,2024-03-26,ACTUAL,2024-03-26,2024-03-26,ACTUAL,2024-03-26,,INTERVENTIONAL,,,Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS,"A Multi-center, Open-label, Randomized Parallel Controlled Evaluation on the Efficacy and Safety of BDB-001 Injection in the Treatment of Progressive Severe COVID-19 in Phase II/III",TERMINATED,,PHASE2/PHASE3,369.0,ACTUAL,"Staidson (Beijing) Biopharmaceuticals Co., Ltd",,2.0,,"Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,INDUSTRY,,,,,,,2024,0.0
NCT03758729,,2018-11-28,,,2021-02-14,2018-11-28,2018-11-29,ACTUAL,,,,,,,2021-02-14,2021-02-16,ACTUAL,2020-05,ESTIMATED,2020-05-31,2021-02,2021-02-28,2020-05-11,ACTUAL,2020-05-11,2020-05,ESTIMATED,2020-05-31,,INTERVENTIONAL,,,"Phase II Study of Nivolumab in Combination With Radiation Therapy as Definitive Treatment for Patients With Locally Advanced, Unresectable Head and Neck Mucosal Melanoma.","Phase II Study of Nivolumab in Combination With Radiation Therapy as Definitive Treatment for Patients With Locally Advanced, Unresectable Head and Neck Mucosal Melanoma.",WITHDRAWN,,PHASE2,0.0,ACTUAL,Samsung Medical Center,,1.0,,Internal Issues,f,,,,f,f,f,,,,,,,,,,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,OTHER,,,,,,,2020,0.0
NCT02509403,,2015-07-24,,,2020-03-30,2015-07-24,2015-07-28,ESTIMATED,,,,,,,2020-03-30,2020-04-01,ACTUAL,2020-01,ESTIMATED,2020-01-31,2020-03,2020-03-31,2020-01,ESTIMATED,2020-01-31,2020-01,ESTIMATED,2020-01-31,,INTERVENTIONAL,WIPEAWAY,,An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel,An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel - WIPEAWAY,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Alberta,,1.0,,The company responsible for funding has filed for bankruptcy,f,,,,f,f,f,,,,,,,,,,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,OTHER,,,,,,,2020,0.0
NCT04871425,,2021-04-26,2022-02-03,,2022-03-22,2021-04-28,2021-05-04,ACTUAL,2022-03-22,2022-03-24,ACTUAL,,,,2022-03-22,2022-03-24,ACTUAL,2021-04-27,ACTUAL,2021-04-27,2022-03,2022-03-31,2021-10-14,ACTUAL,2021-10-14,2021-10-14,ACTUAL,2021-10-14,,INTERVENTIONAL,,"We recruited and randomized 110 participants. After randomization, five participants in the ketamine group were excluded due to two participants receiving the wrong medication, one participant not achieving IV access, one not having transportation, and one being hypertensive. Thus, 52 participants received ketamine and 53 participants received fentanyl.",Ketamine Versus Fentanyl for Surgical Abortions,Ketamine Versus Fentanyl for Surgical Abortions: A Randomized Controlled Noninferiority Trial,COMPLETED,,PHASE4,110.0,ACTUAL,University of Washington,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,OTHER,,,,,,,2021,1.0
NCT05412004,,2022-05-25,,,2024-05-28,2022-06-08,2022-06-09,ACTUAL,,,,,,,2024-05-28,2024-05-30,ACTUAL,2022-06-21,ACTUAL,2022-06-21,2024-05,2024-05-31,2024-03-29,ACTUAL,2024-03-29,2024-03-12,ACTUAL,2024-03-12,,INTERVENTIONAL,SURMOUNT-OSA,,Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea,"A Master Protocol to Investigate the Efficacy and Safety of Tirzepatide Once Weekly in Participants Who Have Obstructive Sleep Apnea and Obesity: A Randomized, Double-Blind, Placebo-Controlled Trial",COMPLETED,,PHASE3,469.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,INDUSTRY,,,,,,,2024,1.0
NCT04854486,,2021-04-17,,,2023-10-12,2021-04-17,2021-04-22,ACTUAL,,,,,,,2023-10-12,2023-10-16,ACTUAL,2021-12-16,ACTUAL,2021-12-16,2023-10,2023-10-31,2022-11-16,ACTUAL,2022-11-16,2022-03-30,ACTUAL,2022-03-30,,INTERVENTIONAL,,,Impact of GSE and Xylitol (Xlear) on COVID-19 Symptoms and Time to PCR Negativisation in COVID-19 Patients,Impact of GSE and Xylitol (Xlear) in Symptoms and Time to PCR Negativisation of Patients With Acute COVID-19 Infection,WITHDRAWN,,PHASE3,0.0,ACTUAL,Larkin Community Hospital,,2.0,,Study Period Ended / Not Completed,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,OTHER,,,,,,,2022,0.0
NCT03582137,,2018-04-17,2023-03-21,,2024-07-01,2018-06-27,2018-07-10,ACTUAL,2024-07-01,2024-07-23,ACTUAL,,,,2024-07-01,2024-07-23,ACTUAL,2018-09-05,ACTUAL,2018-09-05,2024-07,2024-07-31,2022-01-04,ACTUAL,2022-01-04,2022-01-04,ACTUAL,2022-01-04,,INTERVENTIONAL,,,A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease,"A Randomized, Double Blind, Placebo-controlled Parallel Study of Tolerability and Efficacy of Cannabidiol (CBD) on Motor Symptoms in Parkinson's Disease",COMPLETED,,PHASE2,74.0,ACTUAL,"University of Colorado, Denver",,2.0,,,f,,,,t,t,f,,,,,,20 months after the trial is electronically published.,by request from qualified investigators who provide a valid research question; as approved by Principal Investigator,,YES,"Anonymized data not published within this article will be made available by request from qualified investigators who provide a valid research question, for 20 months after the trial is electronically published.",2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,OTHER,,,,,,,2022,1.0
NCT06187376,,2023-12-13,,,2024-07-19,2023-12-29,2024-01-02,ACTUAL,,,,,,,2024-07-19,2024-07-23,ACTUAL,2024-07,ESTIMATED,2024-07-31,2024-07,2024-07-31,2024-07-16,ACTUAL,2024-07-16,2024-07-16,ACTUAL,2024-07-16,,INTERVENTIONAL,,,Chinese Herbal Medicine for Gynecologic Patients,Evaluating the Safety and Acceptability of Using Chinese Herbal Medicine in Patients With Primary Dysmenorrhea: A Randomized-controlled Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,2.0,,Study withdrawn due to inability to determine path forward regarding study design between sponsor and institutional staff.,f,,,,f,f,f,,,,,,Immediately following publication. No end date.,Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.~To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in the University's data warehouse but without investigator support other than deposited metadata.,,YES,"All of the individual participant data collected during the trial, after deidentification.",2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,OTHER,,,,,,,2024,0.0
NCT02655692,,2016-01-07,2021-10-25,,2022-05-06,2016-01-11,2016-01-14,ESTIMATED,2022-05-06,2022-06-02,ACTUAL,,,,2022-05-06,2022-06-02,ACTUAL,2016-04-18,ACTUAL,2016-04-18,2022-05,2022-05-31,2020-07-01,ACTUAL,2020-07-01,2020-07-01,ACTUAL,2020-07-01,,INTERVENTIONAL,,All available data was utilized in the analysis using raw means and SDs,CAP-Ketamine for Antidepressant Resistant PTSD,CAP-Ketamine for Antidepressant Resistant PTSD,COMPLETED,,PHASE2,163.0,ACTUAL,VA Office of Research and Development,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,FED,,,,,,,2020,0.0
NCT04880213,,2021-05-05,,,2022-04-05,2021-05-05,2021-05-10,ACTUAL,,,,,,,2022-04-05,2022-04-06,ACTUAL,2021-05-06,ACTUAL,2021-05-06,2022-03,2022-03-31,2021-11-23,ACTUAL,2021-11-23,2021-11-23,ACTUAL,2021-11-23,,INTERVENTIONAL,,,Study of M5049 in Healthy Japanese and Caucasian Participants,"A Phase I, Open-label, Single-dose, Sequential Dose Group Study of Orally Administered M5049 Tablet Formulation in Healthy Japanese and Caucasian Participants to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics",COMPLETED,,PHASE1,36.0,ACTUAL,"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany",,6.0,,,f,,,,f,f,f,,,,,,,,,NO,"Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html",2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,INDUSTRY,,,,,,,2021,1.0
NCT05310084,,2022-03-25,2023-10-04,,2024-05-14,2022-03-25,2022-04-04,ACTUAL,2023-11-22,2023-11-24,ACTUAL,,,,2024-05-14,2024-06-12,ACTUAL,2022-04-20,ACTUAL,2022-04-20,2024-05,2024-05-31,2022-10-05,ACTUAL,2022-10-05,2022-10-05,ACTUAL,2022-10-05,,INTERVENTIONAL,,Safety population included all participants who received any of the study intervention.,Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age,"A PHASE 3, RANDOMIZED, OBSERVER-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF BNT162b2 WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE (SIIV) IN ADULTS 18 THROUGH 64 YEARS OF AGE",COMPLETED,,PHASE3,1134.0,ACTUAL,BioNTech SE,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,INDUSTRY,,,,,,,2022,1.0
NCT04496674,,2020-05-08,,,2023-07-20,2020-07-29,2020-08-03,ACTUAL,,,,,,,2023-07-20,2023-07-24,ACTUAL,2022-02-02,ACTUAL,2022-02-02,2023-07,2023-07-31,2023-05-03,ACTUAL,2023-05-03,2023-05-03,ACTUAL,2023-05-03,,INTERVENTIONAL,,,Bispecific PSMAxCD3 Antibody CC-1 in Patients With Squamous Cell Carcinoma of the Lung,"PPhase-I Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific PSMAxCD3 Antibody CC-1 as Single Agent and Combined With Checkpoint Blockade in Patients With Squamous Cell Carcinoma of the Lung",TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,German Cancer Research Center,,1.0,,premature termination of the trial due to bad recruitment,f,,,,t,f,f,,,,,,,,,,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,OTHER,,,,,,,2023,0.0
NCT02724020,,2016-03-25,2021-02-01,,2021-11-18,2016-03-30,2016-03-31,ESTIMATED,2021-02-01,2021-02-21,ACTUAL,,,,2021-11-18,2021-11-19,ACTUAL,2016-06-30,ACTUAL,2016-06-30,2021-11,2021-11-30,2020-10-13,ACTUAL,2020-10-13,2020-02-03,ACTUAL,2020-02-03,,INTERVENTIONAL,,Full Analysis Set included all randomized participants.,MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma,"A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Single-Agent MLN0128 and the Combination of MLN0128+MLN1117 Compared With Everolimus in the Treatment of Adult Patients With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma That Has Progressed on Vascular Endothelial Growth Factor-Targeted Therapy",COMPLETED,,PHASE2,96.0,ACTUAL,Takeda,,3.0,,,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,INDUSTRY,,,,,,,2020,1.0
NCT03548935,,2018-05-25,2021-06-16,2021-03-03,2021-11-18,2018-05-25,2018-06-07,ACTUAL,2021-07-20,2021-08-11,ACTUAL,2021-07-20,2021-08-11,ACTUAL,2021-11-18,2021-11-19,ACTUAL,2018-06-04,ACTUAL,2018-06-04,2021-11,2021-11-30,2021-03-05,ACTUAL,2021-03-05,2020-03-30,ACTUAL,2020-03-30,,INTERVENTIONAL,STEP 1,Full analysis set (FAS) included all randomized participants.,STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity,Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity,COMPLETED,,PHASE3,1961.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com/sharing-results,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,INDUSTRY,,,,,,,2021,1.0
NCT03746704,,2018-11-15,,,2022-02-07,2018-11-15,2018-11-20,ACTUAL,,,,,,,2022-02-07,2022-02-23,ACTUAL,2019-09-04,ACTUAL,2019-09-04,2022-02,2022-02-28,2021-07-08,ACTUAL,2021-07-08,2021-07-08,ACTUAL,2021-07-08,,INTERVENTIONAL,,,Study of ImmunoPet Imaging of PD-L1 in Tumors Using 89Zr-DFO-REGN3504 in Adult Participants With Advanced PD-L1 Positive Malignancies,"A Phase 1, First-in-Human Study of ImmunoPET Imaging of PD-L1 in Tumors Using 89Zr-DFO-REGN3504, an Anti-PD-L1 Tracer for Positron Emission Tomography in Patients With Advanced PD-L1 Positive Malignancies",TERMINATED,,PHASE1,2.0,ACTUAL,Regeneron Pharmaceuticals,,1.0,,Business decision,f,,,,f,t,f,,,,,,"Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.","Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).",https://vivli.org/,YES,All individual patient data (IPD) that underlie publicly available results will be considered for sharing,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,INDUSTRY,,,,,,,2021,0.0
NCT04820621,,2021-03-26,,,2021-07-13,2021-03-26,2021-03-29,ACTUAL,,,,,,,2021-07-13,2021-07-15,ACTUAL,2021-04-07,ACTUAL,2021-04-07,2021-07,2021-07-31,2021-07-01,ACTUAL,2021-07-01,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,,,Study of the Influence of Liver Function on Blood Concentrations of Runcaciguat in Participants With Different Degrees of Liver Impairment,"Investigation of the Pharmacokinetics, Safety and Tolerability of Runcaciguat in Participants With Hepatic Impairment (Classified as Child Pugh A or B) and in a Control Group of Age-, Weight-, and Gender-matched Participants Following a Single Oral 15 mg Modified Release (MR) Tablet Dose in a Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification",TERMINATED,,PHASE1,5.0,ACTUAL,Bayer,,3.0,,This study is prematurely terminated due to changes in sponsor's overall development strategy. The decision of termination is not related to any safety concern of the compound.,f,,,,f,f,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,INDUSTRY,,,,,,,2021,0.0
NCT03251144,,2017-08-06,2022-03-22,,2022-04-19,2017-08-11,2017-08-16,ACTUAL,2022-04-19,2022-05-10,ACTUAL,,,,2022-04-19,2022-05-10,ACTUAL,2019-04-01,ACTUAL,2019-04-01,2022-04,2022-04-30,2021-07-01,ACTUAL,2021-07-01,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,UCLACAREMITO,Patients on TAF based vs TDF based ART,Relative Mitochondrial Toxicity of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF),In Vitro and in Vivo Studies of the Relative Mitochondrial Toxicity of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF),COMPLETED,,PHASE1/PHASE2,26.0,ACTUAL,"University of California, Los Angeles",,1.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,OTHER,,,,,,,2021,1.0
NCT04170543,,2019-11-18,2024-05-14,,2024-07-08,2019-11-18,2019-11-20,ACTUAL,2024-07-08,2024-07-10,ACTUAL,,,,2024-07-08,2024-07-10,ACTUAL,2019-11-18,ACTUAL,2019-11-18,2024-07,2024-07-31,2023-05-16,ACTUAL,2023-05-16,2023-05-16,ACTUAL,2023-05-16,,INTERVENTIONAL,,,A Phase 2b Diabetic Kidney Disease Study,"A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects With Diabetic Kidney Disease",COMPLETED,,PHASE2,609.0,ACTUAL,AstraZeneca,"41 randomized participants were excluded from analysis populations in order to avoid heterogeneity in the data (bias, etc.) :~* 2 participants did not received any IP~* 24 participants were enrolled in phase 2a without having the possibility to be enrolled in phase 2b~* 15 participants were randomized in a site with GCP breach (inability to confirm the validity of the data reported)~These 41 participants are excluded from Baseline characteristics (558 participants).",5.0,,,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared",2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,INDUSTRY,,,,,,,2023,1.0
NCT04191382,,2019-12-05,2022-05-27,2022-02-28,2022-06-27,2019-12-05,2019-12-09,ACTUAL,2022-06-27,2022-06-29,ACTUAL,2022-06-27,2022-06-29,ACTUAL,2022-06-27,2022-06-29,ACTUAL,2020-02-04,ACTUAL,2020-02-04,2022-06,2022-06-30,2021-05-28,ACTUAL,2021-05-28,2021-04-30,ACTUAL,2021-04-30,,INTERVENTIONAL,AMEERA-4,Analysis was performed on intent-to-treat (ITT) population that included all enrolled participants for whom there was a confirmation of successful allocation of a randomization number by interactive response technology (IRT) and were analyzed according to the treatment arm assigned at randomization.,"Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer","Phase 2 Window Study of Two Dose Levels of Amcenestrant [SAR439859] (SERD) Versus Letrozole in Newly Diagnosed Pre-operative Post-menopausal Patients With ER Positive, HER2 Negative Primary Breast Cancer",TERMINATED,,PHASE2,105.0,ACTUAL,Sanofi,The study recruitment discontinued early based on strategic sponsor decision that was not driven by any safety concerns. No inferential statistical analysis was performed due to early termination.,3.0,,early discontinuation based on strategic sponsor decision not driven by any safety concerns,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,INDUSTRY,,,,,,,2021,0.0
NCT06006416,,2023-08-01,,,2023-11-16,2023-08-22,2023-08-23,ACTUAL,,,,,,,2023-11-16,2023-11-18,ACTUAL,2023-09-01,ESTIMATED,2023-09-01,2023-11,2023-11-30,2024-09-01,ESTIMATED,2024-09-01,2024-05-01,ESTIMATED,2024-05-01,,INTERVENTIONAL,,,Effect of Fenugreek Fibre on Gut Microbiome,"Effect of Fenugreek Fibre (Trigonella Foenum-graecum) on the Gut Microbiome in an Adult Population - An Open Label, Self-controlled Trial",WITHDRAWN,,PHASE3,0.0,ACTUAL,RDC Clinical Pty Ltd,,1.0,,The Sponsor decided not to conduct the study.,f,,,,,f,f,,,,,,,,,NO,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,INDUSTRY,,,,,,,2024,0.0
NCT05867056,,2023-04-12,,,2024-10-09,2023-05-10,2023-05-19,ACTUAL,,,,,,,2024-10-09,2024-10-15,ACTUAL,2020-08-12,ACTUAL,2020-08-12,2024-10,2024-10-31,2024-12-15,ESTIMATED,2024-12-15,2024-09-10,ESTIMATED,2024-09-10,,INTERVENTIONAL,,,Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection,"An Open-label Study Evaluating the Safety, Antiviral Activity, and Pharmacokinetics of IMC-I109V in HLA-A*02:01 Positive Participants With Chronic HBV Infection Who Are Non-Cirrhotic, Hepatitis B e Antigen-negative, and Virally Suppressed",WITHDRAWN,,PHASE1,0.0,ACTUAL,Immunocore Ltd,,3.0,,Enrollment into the phase 2 portion was never initiated.,f,,,,t,t,f,,,,,,,,,,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,INDUSTRY,,,,,,,2024,0.0
NCT04444466,,2020-06-19,,,2022-07-15,2020-06-19,2020-06-23,ACTUAL,,,,,,,2022-07-15,2022-07-19,ACTUAL,2020-06-30,ACTUAL,2020-06-30,2022-07,2022-07-31,2021-08-02,ACTUAL,2021-08-02,2021-08-02,ACTUAL,2021-08-02,,INTERVENTIONAL,,,"A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UCB8600 in Healthy Participants, Atopic Participants, and Chronic Spontaneous Urticaria Participants","A First-In-Human, Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UCB8600 in Healthy Participants, Atopic Participants, and Chronic Spontaneous Urticaria Participants",TERMINATED,,PHASE1,40.0,ACTUAL,UCB Pharma,,2.0,,internal company decision; not safety related,f,,,,f,f,f,,,,,,,,,NO,"Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.",2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,INDUSTRY,,,,,,,2021,0.0
NCT03669588,,2018-09-06,2022-01-14,2021-03-15,2022-01-14,2018-09-11,2018-09-13,ACTUAL,2022-01-14,2022-02-08,ACTUAL,2021-03-15,2021-03-18,ACTUAL,2022-01-14,2022-02-08,ACTUAL,2018-08-22,ACTUAL,2018-08-22,2021-03,2021-03-31,2020-04-06,ACTUAL,2020-04-06,2020-04-06,ACTUAL,2020-04-06,,INTERVENTIONAL,ADAPT,All patients in the randomized population who received at least a partial dose of investigational medicinal product (IMP) were included in the baseline analysis.,An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness,"A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness",COMPLETED,,PHASE3,167.0,ACTUAL,argenx,,2.0,,,t,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,INDUSTRY,,NCT04777734,APPROVED_FOR_MARKETING,,,,2020,1.0
NCT03638128,,2018-06-21,2022-10-24,,2022-11-28,2018-08-16,2018-08-20,ACTUAL,2022-11-28,2022-12-20,ACTUAL,,,,2022-11-28,2022-12-20,ACTUAL,2018-07-26,ACTUAL,2018-07-26,2022-11,2022-11-30,2022-03-28,ACTUAL,2022-03-28,2022-03-28,ACTUAL,2022-03-28,,INTERVENTIONAL,,,Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta,"Multicenter, Single-arm Open-label Extension Study to Assess Long-term Safety and Efficacy of Current or Prior Treatment With Denosumab in Children/Young Adults With Osteogenesis Imperfecta",TERMINATED,,PHASE3,75.0,ACTUAL,Amgen,,3.0,,The study was stopped earlier than planned due to safety concerns about high levels of calcium in the blood of the participants,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,INDUSTRY,,,,,,,2022,0.0
NCT04448119,,2020-06-24,,,2023-02-17,2020-06-24,2020-06-25,ACTUAL,,,,,,,2023-02-17,2023-02-21,ACTUAL,2020-10-16,ACTUAL,2020-10-16,2023-02,2023-02-28,2021-10-30,ACTUAL,2021-10-30,2021-10-30,ACTUAL,2021-10-30,,INTERVENTIONAL,,,Control of COVID-19 Outbreaks in Long Term Care,Control of COVID-19 Outbreaks in Long Term Care (CONTROL-COVID),TERMINATED,,PHASE2,67.0,ACTUAL,Appili Therapeutics Inc.,,2.0,,Recruitment challenges,f,,,,,f,f,,,,,,,,,NO,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,INDUSTRY,,,,,,,2021,0.0
NCT05049525,,2021-08-25,,,2024-05-29,2021-09-16,2021-09-20,ACTUAL,,,,,,,2024-05-29,2024-05-30,ACTUAL,2022-02-22,ACTUAL,2022-02-22,2024-05,2024-05-31,2024-02-28,ACTUAL,2024-02-28,2024-02-28,ACTUAL,2024-02-28,,INTERVENTIONAL,CD-IT,,Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease,Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease Not Responding Adequately to Current Therapy,TERMINATED,,PHASE2,16.0,ACTUAL,Montreal Heart Institute,,2.0,,Insufficient patient enrollment,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,OTHER,,,,,,,2024,0.0
NCT04906382,,2021-03-22,,,2022-09-16,2021-05-24,2021-05-28,ACTUAL,,,,,,,2022-09-16,2022-09-21,ACTUAL,2021-07-01,ACTUAL,2021-07-01,2022-09,2022-09-30,2022-09-01,ACTUAL,2022-09-01,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,,,Tislelizumab for the Treatment of Recurrent Mismatch Repair Deficient Endometrial Cancer,Pilot Study of Tislelizumab (BGB-A317) in Recurrent Mismatch Repair Deficient Endometrial Cancer and the Effect on the Tumor Microenvironment,TERMINATED,,EARLY_PHASE1,2.0,ACTUAL,Ohio State University Comprehensive Cancer Center,,1.0,,Sponsor reorganization,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,OTHER,,,,,,,2022,0.0
NCT03304210,,2017-09-11,2022-01-10,,2023-01-20,2017-10-02,2017-10-06,ACTUAL,2023-01-20,2023-11-07,ACTUAL,,,,2023-01-20,2023-11-07,ACTUAL,2017-09-16,ACTUAL,2017-09-16,2023-01,2023-01-31,2020-05-06,ACTUAL,2020-05-06,2020-05-06,ACTUAL,2020-05-06,,INTERVENTIONAL,PIPAC-nabpac,,"PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer","Intraperitoneal Aerosolization of Albumin-stabilized Paclitaxel Nanoparticles for Stomach, Pancreas, Breast and Ovarian Cancer",COMPLETED,,PHASE1,20.0,ACTUAL,"University Hospital, Ghent",,5.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,OTHER,,,,,,,2020,1.0
NCT01925378,,2013-04-30,,,2020-11-09,2013-08-15,2013-08-19,ESTIMATED,,,,,,,2020-11-09,2020-11-12,ACTUAL,2018-11-07,ACTUAL,2018-11-07,2020-11,2020-11-30,2022-12,ESTIMATED,2022-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,A Phase II Single-arm Intervention Trial of Nelfinavir in Patients With Grade 2/3 or 3 Cervical Intraepithelial Neoplasia,A PHASE II SINGLE-ARM INTERVENTION TRIAL OF NELFINAVIR IN PATIENTS WITH GRADE 2/3 or 3 CERVICAL INTRAEPITHELIAL NEOPLASIA,WITHDRAWN,,PHASE2,0.0,ACTUAL,"The University of Texas Health Science Center, Houston",,1.0,,The study is going to open in a new site,f,,,,f,t,f,,,,,,,,,,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,OTHER,,,,,,,2022,0.0
NCT03099486,,2017-03-23,2021-08-24,,2022-01-10,2017-03-28,2017-04-04,ACTUAL,2022-01-10,2022-02-07,ACTUAL,,,,2022-01-10,2022-02-07,ACTUAL,2017-10-06,ACTUAL,2017-10-06,2022-01,2022-01-31,2020-06-02,ACTUAL,2020-06-02,2020-06-02,ACTUAL,2020-06-02,,INTERVENTIONAL,,,Regorafenib Plus 5-Fluorouracil/Leucovorin Beyond Progression in mCRC,"A Pilot Phase II, Single Arm, Open Label, Investigator-initiated Clinical Trial of Regorafenib Plus 5-Fluorouracil/Leucovorin (5FU/LV) Beyond Progression on Regorafenib Monotherapy in Metastatic Colorectal Cancer (mCRC)",TERMINATED,,PHASE2,2.0,ACTUAL,Fox Chase Cancer Center,,1.0,,Administrative change,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,OTHER,,,,,,,2020,0.0
NCT04562298,,2020-09-19,,,2022-08-15,2020-09-19,2020-09-24,ACTUAL,,,,,,,2022-08-15,2022-08-18,ACTUAL,2020-10-21,ACTUAL,2020-10-21,2021-10,2021-10-31,2022-06-07,ACTUAL,2022-06-07,2022-06-07,ACTUAL,2022-06-07,,INTERVENTIONAL,,,"A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-M23, a CAR-T Cell Therapy Targeting MSLN in Patients With Relapsed and Refractory Epithelial Ovarian Cancer","A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-M23, a CAR-T Cell Therapy Targeting MSLN in Patients With Relapsed and Refractory Epithelial Ovarian Cancer",TERMINATED,,PHASE1,15.0,ACTUAL,Shanghai East Hospital,,1.0,,Both the sponsors and collaborator are considering terminating the study.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,OTHER,,,,,,,2022,0.0
NCT03946111,,2019-04-22,,,2024-06-06,2019-05-09,2019-05-10,ACTUAL,,,,,,,2024-06-06,2024-06-10,ACTUAL,2019-08-07,ACTUAL,2019-08-07,2024-06,2024-06-30,2023-12-14,ACTUAL,2023-12-14,2023-12-14,ACTUAL,2023-12-14,,INTERVENTIONAL,,,Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders,Cognitive-Behavioral and Pharmacologic Treatment of Binge-Eating Disorder and Obesity,TERMINATED,,PHASE2/PHASE3,3.0,ACTUAL,Yale University,,2.0,,Did not enroll enough participants,f,,,,,t,f,,,,,,,,,,,2024-10-16 12:41:55.468464,2024-10-16 12:41:55.468464,OTHER,,,,,,,2023,0.0
NCT03303950,,2017-10-02,2020-05-14,,2022-05-03,2017-10-05,2017-10-06,ACTUAL,2020-05-14,2020-05-27,ACTUAL,,,,2022-05-03,2022-05-05,ACTUAL,2018-03-30,ACTUAL,2018-03-30,2022-05,2022-05-31,2020-02-19,ACTUAL,2020-02-19,2019-05-14,ACTUAL,2019-05-14,,INTERVENTIONAL,,,Allogeneic Stem Cell Transplantation for Multiple Myeloma and Myelofibrosis,"Busulfan, Fludarabine, Donor Stem Cell Transplant, and Cyclophosphamide in Treating Participants With Multiple Myeloma or Myelofibrosis",TERMINATED,,PHASE2,6.0,ACTUAL,University of Utah,,1.0,,Slow accrual,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,OTHER,,,,,,,2020,0.0
NCT03555149,,2018-05-31,2023-09-22,,2023-11-06,2018-05-31,2018-06-13,ACTUAL,2023-11-06,2023-11-07,ACTUAL,,,,2023-11-06,2023-11-07,ACTUAL,2018-09-27,ACTUAL,2018-09-27,2023-11,2023-11-30,2022-09-26,ACTUAL,2022-09-26,2022-09-26,ACTUAL,2022-09-26,,INTERVENTIONAL,,"All participants who were randomized in the study, regardless of whether they actually received any study treatment.",A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC),"A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)",TERMINATED,,PHASE1/PHASE2,96.0,ACTUAL,Hoffmann-La Roche,"This study is not designed to make explicit power and Type I error considerations for a hypothesis test. Instead, this study is designed to obtain preliminary efficacy, safety, and PK data. No formal statistical hypothesis testing was performed in this study. Due to the limited sample size, the results need to be interpreted with caution. For the Atezo+Idasa and Atezo+LOAd703 groups, no meaningful conclusion could be drawn because these experimental arms have been terminated prematurely.",8.0,,The Sponsor made the decision to terminate the study due to start up and recruitment issues caused by limited resource availability at the treating centers.,f,,,,,t,f,,,,,,,,,,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,INDUSTRY,,,,,,,2022,0.0
NCT01597518,,2012-05-10,,,2021-04-16,2012-05-11,2012-05-14,ESTIMATED,,,,,,,2021-04-16,2021-04-19,ACTUAL,2013-10,ACTUAL,2013-10-31,2021-04,2021-04-30,2020-10-08,ACTUAL,2020-10-08,2020-10-08,ACTUAL,2020-10-08,,INTERVENTIONAL,RISCIS,,Riluzole in Spinal Cord Injury Study,"A Multi-Center, Randomized, Placebo Controlled, Double-Blinded, Trial of Efficacy and Safety of Riluzole in Acute Spinal Cord Injury",TERMINATED,,PHASE2/PHASE3,193.0,ACTUAL,AOSpine North America Research Network,,2.0,,Enrollment challenges/ slow enrollment.,f,,,,t,,,,,,,,,,,,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,NETWORK,,,,,,,2020,0.0
NCT04548791,,2020-09-08,,,2021-12-06,2020-09-08,2020-09-16,ACTUAL,,,,,,,2021-12-06,2021-12-21,ACTUAL,2021-05-17,ACTUAL,2021-05-17,2021-12,2021-12-31,2021-12-03,ACTUAL,2021-12-03,2021-11-15,ACTUAL,2021-11-15,,INTERVENTIONAL,,,Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Inherited Bleeding Disorders,"Phase 1/2 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Marzeptacog Alfa (Activated) in Treatment of Episodic Bleeding in Subjects With Inherited Bleeding Disorders",TERMINATED,,PHASE1/PHASE2,19.0,ACTUAL,Catalyst Biosciences,,3.0,,Company decision (not a safety issue),,,,,,t,f,,,,,,,,,NO,,2024-10-15 02:24:13.259393,2024-10-15 02:24:13.259393,INDUSTRY,,,,,,,2021,0.0
NCT04843761,,2021-04-09,,,2023-05-01,2021-04-09,2021-04-14,ACTUAL,,,,,,,2023-05-01,2023-05-03,ACTUAL,2021-04-20,ACTUAL,2021-04-20,2023-05,2023-05-31,2022-11-20,ACTUAL,2022-11-20,2022-08-22,ACTUAL,2022-08-22,,INTERVENTIONAL,TESICO,,ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19,"A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With Acute Respiratory Distress Syndrome Associated With COVID-19",COMPLETED,,PHASE3,473.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,4.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,NIH,,,,,,,2022,0.0
NCT05784129,,2023-03-13,,,2023-11-08,2023-03-13,2023-03-24,ACTUAL,,,,,,,2023-11-08,2023-11-13,ACTUAL,2023-02-21,ACTUAL,2023-02-21,2023-11,2023-11-30,2023-10-10,ACTUAL,2023-10-10,2023-09-29,ACTUAL,2023-09-29,,INTERVENTIONAL,PROGRESS,,A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection,"A Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection",TERMINATED,,PHASE3,4.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,Janssen made an internal business decision to discontinue the PROGRESS study. This decision is not related to any efficacy or safety concerns.,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,INDUSTRY,,,,,,,2023,0.0
NCT03028571,,2017-01-18,,,2021-06-03,2017-01-19,2017-01-23,ESTIMATED,,,,,,,2021-06-03,2021-06-08,ACTUAL,2017-04-17,ACTUAL,2017-04-17,2021-06,2021-06-30,2024-12-31,ESTIMATED,2024-12-31,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Autonomic Blockade and Endogenous Glucose Production,Acute Sympathetic Blockade and Endogenous Glucose Production,WITHDRAWN,,PHASE1,0.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,The investigators decided not to perform the study. No participants have been enrolled.,f,,,,,t,f,,,,,,,,,,,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,OTHER,,,,,,,2024,0.0
NCT03110107,,2017-04-07,,,2024-05-02,2017-04-07,2017-04-12,ACTUAL,,,,,,,2024-05-02,2024-05-03,ACTUAL,2017-05-04,ACTUAL,2017-05-04,2024-04,2024-04-30,2024-04-04,ACTUAL,2024-04-04,2024-04-04,ACTUAL,2024-04-04,,INTERVENTIONAL,,,First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors,Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors,TERMINATED,,PHASE1/PHASE2,512.0,ACTUAL,Bristol-Myers Squibb,,6.0,,Business Objectives have changed.,f,,,,f,t,f,,,,,,,,,,,2024-10-17 01:36:28.678517,2024-10-17 01:36:28.678517,INDUSTRY,,,,,,,2024,0.0
NCT03550794,,2018-05-25,2023-05-01,,2023-06-02,2018-06-07,2018-06-08,ACTUAL,2023-06-02,2023-06-27,ACTUAL,,,,2023-06-02,2023-06-27,ACTUAL,2018-09-04,ACTUAL,2018-09-04,2023-06,2023-06-30,2022-04-05,ACTUAL,2022-04-05,2022-04-05,ACTUAL,2022-04-05,,INTERVENTIONAL,,,Thiamine as a Renal Protective Agent in Septic Shock,"Thiamine as a Renal Protective Agent in Septic Shock: A Randomized, Controlled Study",COMPLETED,,PHASE2,95.0,ACTUAL,Beth Israel Deaconess Medical Center,,2.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,OTHER,,,,,,,2022,1.0
NCT04391309,,2020-05-14,2023-04-06,,2023-06-20,2020-05-14,2020-05-18,ACTUAL,2023-05-22,2023-06-15,ACTUAL,,,,2023-06-20,2023-06-26,ACTUAL,2021-04-12,ACTUAL,2021-04-12,2023-06,2023-06-30,2022-02-04,ACTUAL,2022-02-04,2022-02-04,ACTUAL,2022-02-04,,INTERVENTIONAL,CaTT,"Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product. Measures reflect the assessment of clinical status at baseline.",COVID-19 and Anti-CD14 Treatment Trial,"Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Anti-CD14 Treatment in Hospitalized Patients With COVID-19",TERMINATED,,PHASE2,49.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),The trial was terminated early because of slow recruitment and cannot be considered fully powered.,2.0,,Stopped to slow rate of enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:43:16.968743,2024-10-15 16:43:16.968743,NIH,,,,,,,2022,0.0
NCT04395339,,2020-05-06,,,2024-07-30,2020-05-14,2020-05-20,ACTUAL,,,,,,,2024-07-30,2024-08-01,ACTUAL,2020-05-15,ACTUAL,2020-05-15,2024-07,2024-07-31,2024-07-31,ACTUAL,2024-07-31,2024-07-31,ACTUAL,2024-07-31,,INTERVENTIONAL,GLORY,,GM1 Prophylaxis for WBRT Related Cognitive Dysfunction,Ganglioside-Monosialic Acid Prophylaxis for Cognitive Dysfunction Related to Whole Brain Radiotherapy in Breast Cancer Patients With Brain Metastases ，a Multi-center，Randomized，Single Blind，Phase III Clinical Trail,TERMINATED,,PHASE3,51.0,ACTUAL,Sun Yat-sen University,,2.0,,Difficulty accruing subjects the study accrual was closed,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,OTHER,,,,,,,2024,0.0
NCT03760965,,2018-11-29,,,2022-04-21,2018-11-29,2018-12-03,ACTUAL,,,,,,,2022-04-21,2022-04-25,ACTUAL,2018-11-27,ACTUAL,2018-11-27,2022-04,2022-04-30,2020-04-24,ACTUAL,2020-04-24,2020-04-24,ACTUAL,2020-04-24,,INTERVENTIONAL,,,Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise,"A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin as Monotherapy in Chinese Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Diet and Exercise",TERMINATED,,PHASE3,276.0,ACTUAL,Sanofi,,3.0,,Sanofi ended collaboration with Lexicon for Sotagliflozin. In China no regulatory pathway to transfer sponsorship during the conduct of ongoing studies.,f,,,,f,f,f,,,f,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,INDUSTRY,,,,,,,2020,0.0
NCT04354714,,2020-04-16,,,2020-05-19,2020-04-16,2020-04-21,ACTUAL,,,,,,,2020-05-19,2020-05-21,ACTUAL,2020-06-30,ESTIMATED,2020-06-30,2020-05,2020-05-31,2021-12-31,ESTIMATED,2021-12-31,2021-07-31,ESTIMATED,2021-07-31,,INTERVENTIONAL,,,Ruxolitinib to Combat COVID-19,A Pilot Study of Ruxolitinib to Combat COVID-19,WITHDRAWN,,PHASE2,0.0,ACTUAL,Washington University School of Medicine,,1.0,,Could not make FDA required changes,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,OTHER,,,,,,,2021,0.0
NCT02551991,,2015-09-10,2022-05-20,,2022-10-07,2015-09-15,2015-09-16,ESTIMATED,2022-10-07,2022-10-10,ACTUAL,,,,2022-10-07,2022-10-10,ACTUAL,2015-10-19,ACTUAL,2015-10-19,2022-10,2022-10-31,2021-02-15,ACTUAL,2021-02-15,2021-02-15,ACTUAL,2021-02-15,,INTERVENTIONAL,,Safety population included participants who received at least 1 dose of any study treatment.,"Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma","A Randomized, Open-label Phase 2 Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-Paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma",COMPLETED,,PHASE2,56.0,ACTUAL,Ipsen,"The comparative Part 2 was removed in a protocol amendment, dated 11 April 2018, before it was initiated, as this comparative part of the study is being undertaken as a stand-alone Phase 3 study D-US-60010-001.",1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,INDUSTRY,,,,,,,2021,1.0
NCT03863288,,2018-09-25,,,2024-04-25,2019-03-04,2019-03-05,ACTUAL,,,,,,,2024-04-25,2024-04-26,ACTUAL,2022-02-18,ACTUAL,2022-02-18,2024-04,2024-04-30,2024-02-27,ACTUAL,2024-02-27,2024-02-27,ACTUAL,2024-02-27,,INTERVENTIONAL,,,Dose Response Relationship of Oxytocin on Irritability in Youths,Dose-Response Relationship and Pharmacokinetics of Intranasal Oxytocin on Neural Impact in Youth With High Levels of Irritability,TERMINATED,,PHASE1/PHASE2,60.0,ACTUAL,University of Nebraska,,5.0,,Per DSMB's recommendation,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2024,0.0
NCT03087513,,2017-03-06,2020-05-01,,2020-06-02,2017-03-16,2017-03-22,ACTUAL,2020-05-15,2020-06-01,ACTUAL,,,,2020-06-02,2020-06-17,ACTUAL,2018-02-05,ACTUAL,2018-02-05,2020-06,2020-06-30,2020-04-30,ACTUAL,2020-04-30,2019-12-30,ACTUAL,2019-12-30,,INTERVENTIONAL,,,A Randomized Controlled Crossover Study Comparing Sugammadex and Placebo,Effect of Reversal of Neuromuscular Blockade on the Amplitude of Motor Evoked Potentials: A Randomized Controlled Crossover Study Comparing Sugammadex and Placebo,COMPLETED,,PHASE4,40.0,ACTUAL,"University Health Network, Toronto",,2.0,,,f,,,,,f,f,,,f,,,,,,NO,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2020,1.0
NCT01202994,,2010-09-14,2017-05-01,,2023-04-13,2010-09-14,2010-09-16,ESTIMATED,2017-12-12,2018-01-11,ACTUAL,,,,2023-04-13,2023-05-09,ACTUAL,2011-05,,2011-05-31,2018-01,2018-01-31,2020-10-14,ACTUAL,2020-10-14,2016-05,ACTUAL,2016-05-31,,INTERVENTIONAL,,,Practice Effects and Amyloid Imaging Using 18F-PIB or Flutemetamol PET and FDG-PET,Practice Effects and Amyloid Imaging Using 18F-PIB (18F-39-F-6-OH-BTA1) Known as [18FGE067]) or Flutemetamol PET and FDG-PET,COMPLETED,,PHASE2,27.0,ACTUAL,University of Utah,,1.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,OTHER,,,,,,,2020,1.0
NCT03084536,,2017-03-08,2022-02-07,,2022-03-03,2017-03-14,2017-03-21,ACTUAL,2022-03-03,2022-03-31,ACTUAL,,,,2022-03-03,2022-03-31,ACTUAL,2017-06-07,ACTUAL,2017-06-07,2022-03,2022-03-31,2021-02-25,ACTUAL,2021-02-25,2021-02-25,ACTUAL,2021-02-25,,INTERVENTIONAL,,,PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery,PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery,COMPLETED,,PHASE2,134.0,ACTUAL,Washington University School of Medicine,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,OTHER,,,,,,,2021,1.0
NCT04417894,,2020-06-02,2023-08-28,,2023-12-01,2020-06-02,2020-06-05,ACTUAL,2023-12-01,2023-12-22,ACTUAL,,,,2023-12-01,2023-12-22,ACTUAL,2021-04-14,ACTUAL,2021-04-14,2023-12,2023-12-31,2022-11-23,ACTUAL,2022-11-23,2022-08-31,ACTUAL,2022-08-31,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis (Liberty-AD-HAFT),"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis",COMPLETED,,PHASE3,133.0,ACTUAL,Regeneron Pharmaceuticals,,2.0,,,f,,,,f,t,f,,,,,,"Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.","Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).",https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,INDUSTRY,,,,,,,2022,1.0
NCT03043053,,2017-02-01,2023-08-22,2023-05-11,2024-01-12,2017-02-02,2017-02-03,ESTIMATED,2024-01-12,2024-02-07,ACTUAL,,2024-02-07,ACTUAL,2024-01-12,2024-02-07,ACTUAL,2017-07-01,ACTUAL,2017-07-01,2024-01,2024-01-31,2022-07-07,ACTUAL,2022-07-07,2022-05-20,ACTUAL,2022-05-20,,INTERVENTIONAL,,"Safety cohort, which was defined as all randomly assigned participants who received at least one dose of study drug.",The Effects of Oxytocin in Obese Adults,"A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Repeat Doses of Intranasal Oxytocin in Obese Adults",COMPLETED,,PHASE2,61.0,ACTUAL,Massachusetts General Hospital,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,OTHER,,,,,,,2022,0.0
NCT03881995,,2019-02-19,,,2020-07-08,2019-03-15,2019-03-20,ACTUAL,,,,,,,2020-07-08,2020-07-10,ACTUAL,2019-03-18,ACTUAL,2019-03-18,2020-05,2020-05-31,2020-06-29,ACTUAL,2020-06-29,2020-06-29,ACTUAL,2020-06-29,,INTERVENTIONAL,Lixibrain01,,Effects of Insulin Glargine and Lixisenatide on the Brain,Effect of Insulin Glargine and Lixisenatide Versus Insulin Glargine on Brain Insulin Sensitivity in Patients With Type 2 Diabetes,TERMINATED,,PHASE4,1.0,ACTUAL,University Hospital Tuebingen,,2.0,,insufficient recruitment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,OTHER,,,,,,,2020,0.0
NCT04025216,,2019-07-12,,,2024-01-22,2019-07-16,2019-07-18,ACTUAL,,,,,,,2024-01-22,2024-01-24,ACTUAL,2019-10-10,ACTUAL,2019-10-10,2023-04,2023-04-30,2022-12-02,ACTUAL,2022-12-02,2022-12-02,ACTUAL,2022-12-02,,INTERVENTIONAL,,,A Study of CART-TnMUC1 in Patients With TnMUC1-Positive Advanced Cancers,"A Phase 1 Open-Label, Multi-Center First in Human Study of TnMUC1-Targeted Genetically-Modified Chimeric Antigen Receptor T Cells in Patients With Advanced TnMUC1-Positive Solid Tumors and Multiple Myeloma",TERMINATED,,PHASE1,16.0,ACTUAL,Gilead Sciences,,2.0,,The sponsor finds the risk/benefit analysis unfavorable and has terminated the study.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,INDUSTRY,,,,,,,2022,0.0
NCT05015972,,2021-04-21,,,2022-11-23,2021-08-15,2021-08-23,ACTUAL,,,,,,,2022-11-23,2022-11-29,ACTUAL,2021-08-20,ESTIMATED,2021-08-20,2022-11,2022-11-30,2023-12-31,ESTIMATED,2023-12-31,2023-06-30,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,UCAR-T for CD19+ Refractory/Relapsed B Hematologic Malignancies,A Study of CTA30X UCAR-T Cell Injection in the Treatment of Patients With r/r CD19+ B Hematologic Malignancies,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,920th Hospital of Joint Logistics Support Force of People's Liberation Army of China,,1.0,,No proper participant is found.,f,,,,f,f,f,,,,,,,,,,,2024-10-15 16:48:55.07151,2024-10-15 16:48:55.07151,OTHER,,,,,,,2023,0.0
NCT03193346,,2017-06-19,,,2017-07-12,2017-06-19,2017-06-20,ACTUAL,,,,,,,2017-07-12,2017-07-14,ACTUAL,2017-07-03,ESTIMATED,2017-07-03,2017-07,2017-07-31,2021-03-25,ESTIMATED,2021-03-25,2021-03-25,ESTIMATED,2021-03-25,,INTERVENTIONAL,,,BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Participants With Chronic Migraine,"A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine",WITHDRAWN,,PHASE3,0.0,ACTUAL,Allergan,,2.0,,Corporation Decision,f,,,,f,f,f,,,,,,,,,,,2024-10-15 16:48:55.07151,2024-10-15 16:48:55.07151,INDUSTRY,,,,,,,2021,0.0
NCT03577730,,2018-06-08,2021-08-04,,2021-09-09,2018-07-03,2018-07-05,ACTUAL,2021-09-09,2021-10-06,ACTUAL,,,,2021-09-09,2021-10-06,ACTUAL,2018-07-10,ACTUAL,2018-07-10,2021-09,2021-09-30,2020-01-17,ACTUAL,2020-01-17,2019-11-21,ACTUAL,2019-11-21,,INTERVENTIONAL,,,Caffeine and Neurologic Recovery Following Surgery and General Anesthesia,Caffeine and Neurologic Recovery Following Surgery and General Anesthesia,COMPLETED,,EARLY_PHASE1,71.0,ACTUAL,University of Michigan,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 03:33:06.361687,2024-10-16 03:33:06.361687,OTHER,,,,,,,2020,1.0
NCT03580967,,2018-06-25,,,2022-11-22,2018-07-06,2018-07-10,ACTUAL,,,,,,,2022-11-22,2022-11-29,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2022-11,2022-11-30,2021-07-01,ACTUAL,2021-07-01,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,,,Vortioxetine Monotherapy for Major Depressive Disorder in Type 2 Diabetes,"Vortioxetine Monotherapy for Major Depressive Disorder in Type 2 Diabetes: Role of Inflammation, Kynurenine Pathway, and Structural and Functional Brain Connectivity as Biomarkers",WITHDRAWN,,PHASE4,0.0,ACTUAL,Loyola University,,1.0,,COVID-19 Pandemic interfered with Pt recruitment,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 16:48:55.07151,2024-10-15 16:48:55.07151,OTHER,,,,,,,2021,0.0
NCT03047473,,2017-01-31,,,2023-02-17,2017-02-06,2017-02-09,ESTIMATED,,,,,,,2023-02-17,2023-02-22,ACTUAL,2017-03-10,ACTUAL,2017-03-10,2023-02,2023-02-28,2021-08-09,ACTUAL,2021-08-09,2021-08-09,ACTUAL,2021-08-09,,INTERVENTIONAL,SEJ,,Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme,Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme,COMPLETED,,PHASE2,30.0,ACTUAL,Clinique Neuro-Outaouais,,1.0,,,f,,,,,t,f,,,t,,,,,,,,2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,OTHER,,,,,,,2021,0.0
NCT03771885,,2018-12-10,,,2021-11-12,2018-12-10,2018-12-11,ACTUAL,,,,,,,2021-11-12,2021-11-15,ACTUAL,2019-03-16,ESTIMATED,2019-03-16,2021-11,2021-11-30,2020-01-07,ESTIMATED,2020-01-07,2019-12-21,ESTIMATED,2019-12-21,,INTERVENTIONAL,,,BI 705564 in Patients With Systemic Lupus Erythematosus (SLE),"A Phase Ib, Multicentre, Randomised, Double-blind, Placebo Controlled, 8 Week Crossover Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered BI 705564 in Patients With Systemic Lupus Erythematosus.",WITHDRAWN,,PHASE1,0.0,ACTUAL,Boehringer Ingelheim,,2.0,,"Based on a strategic decision, the application for the trial has been withdrawn before initiation.",f,,,,f,f,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-15 16:48:55.07151,2024-10-15 16:48:55.07151,INDUSTRY,,,,,,,2020,0.0
NCT02341209,,2014-11-21,,,2021-04-23,2015-01-13,2015-01-19,ESTIMATED,,,,,,,2021-04-23,2021-04-27,ACTUAL,2018-02-06,ACTUAL,2018-02-06,2021-04,2021-04-30,2021-02-06,ACTUAL,2021-02-06,2021-02-06,ACTUAL,2021-02-06,,INTERVENTIONAL,CTCL,,Doxycycline for the Treatment of Cutaneous T-Cell Lymphoma,Doxycycline in Patients With Relapsed Cutaneous T-cell Lymphoma,TERMINATED,,PHASE2,1.0,ACTUAL,Rochester General Hospital,,1.0,,Low enrollment,f,,,,t,t,f,,,,,,,,,YES,As required,2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,OTHER,,,,,,,2021,0.0
NCT02155634,,2014-06-02,,,2018-04-09,2014-06-02,2014-06-04,ESTIMATED,,,,,,,2018-04-09,2018-04-10,ACTUAL,2014-07,,2014-07-31,2018-04,2018-04-30,2021-03,ESTIMATED,2021-03-31,2017-04,ESTIMATED,2017-04-30,,INTERVENTIONAL,,,"Continuous Lenalidomide Therapy Versus Observation Following Induction Without Lenalidomide, Pomalidomide or Thalidomide in Myeloma","Phase 3b, Randomized Trial of Continuous Revlimid® (Lenalidomide) Therapy Versus Observation Following Induction Therapy That Does Not Include Revlimid, Pomalyst® or Thalomid® in Newly Diagnosed Multiple Myeloma",WITHDRAWN,,PHASE3,0.0,ACTUAL,Celgene,,2.0,,The study was terminated due to poor feasibility and lack of interest at the participating sites.,f,,,,t,,,,,,,,,,,,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,INDUSTRY,,,,,,,2021,0.0
NCT03582384,,2018-06-26,,,2020-05-11,2018-07-09,2018-07-11,ACTUAL,,,,,,,2020-05-11,2020-05-13,ACTUAL,2020-12,ESTIMATED,2020-12-31,2020-05,2020-05-31,2023-01,ESTIMATED,2023-01-31,2022-01,ESTIMATED,2022-01-31,,INTERVENTIONAL,,,Use of Tocofersolan (Vedrop®) to Prevent or Treat Refractive Vitamin E Deficiency in Infants and Children,Use of Tocofersolan (Vedrop®) to Prevent or Treat Refractive Vitamin E Deficiency in Infants and Children,WITHDRAWN,,PHASE2,0.0,ACTUAL,Boston Children's Hospital,,1.0,,Study never started,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,OTHER,,,,,,,2023,0.0
NCT04030572,,2019-07-22,,,2021-06-21,2019-07-23,2019-07-24,ACTUAL,,,,,,,2021-06-21,2021-06-24,ACTUAL,2019-12-10,ACTUAL,2019-12-10,2021-06,2021-06-30,2020-03-17,ACTUAL,2020-03-17,2020-03-17,ACTUAL,2020-03-17,,INTERVENTIONAL,a2a Agonist,,Feasibility of Administering Clonidine as a Pharmacological Challenge in Imaging Studies,"Pilot Study to Assess the Safety, Tolerability, and Feasibility of Administering Clonidine as a Pharmacological Challenge in Future Imaging Studies of Cerebrospinal Fluid Kinetics",TERMINATED,,EARLY_PHASE1,3.0,ACTUAL,Weill Medical College of Cornell University,,1.0,,Not logistically feasible during the COVID pandemic,f,,,,f,t,f,,,f,,,"Data will be made available within six months of last study visit or acceptance for publication, whichever comes first.",Any reasonable request sent to dvm9029@med.cornell.edu,,YES,All de-identified on-study data will be shared.,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2020,0.0
NCT01100502,,2010-04-06,2015-07-31,,2021-04-22,2010-04-08,2010-04-09,ESTIMATED,2015-10-07,2015-11-11,ESTIMATED,,,,2021-04-22,2021-05-14,ACTUAL,2010-04-30,ACTUAL,2010-04-30,2021-04,2021-04-30,2020-04-27,ACTUAL,2020-04-27,2014-08-31,ACTUAL,2014-08-31,,INTERVENTIONAL,,Intention-to-Treat analysis set,A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial),"A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant",COMPLETED,,PHASE3,329.0,ACTUAL,Seagen Inc.,,2.0,,,t,,,,t,t,f,,,,,,,,,,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,INDUSTRY,,NCT01196208,NO_LONGER_AVAILABLE,,,,2020,1.0
NCT03815916,,2019-01-18,2023-09-05,,2024-05-07,2019-01-23,2019-01-24,ACTUAL,2024-05-07,2024-05-16,ACTUAL,,,,2024-05-07,2024-05-16,ACTUAL,2019-12-19,ACTUAL,2019-12-19,2024-05,2024-05-31,2021-06-07,ACTUAL,2021-06-07,2021-06-07,ACTUAL,2021-06-07,,INTERVENTIONAL,REPAIR-PD,Intent to Treat Population (ITT):~The Intent to Treat population consisted of all screened subjects who were assigned a treatment assignment number.,31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Parkinson's Disease,"A Phase 2, Pilot Open Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Parkinson's Disease",COMPLETED,,PHASE2,13.0,ACTUAL,Clene Nanomedicine,Only 13 participants were enrolled due to difficulties with recruitment that was further complicated by the COVID-19 pandemic.,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 16:48:55.07151,2024-10-15 16:48:55.07151,INDUSTRY,,,,,,,2021,1.0
NCT04759131,,2021-02-13,2023-12-07,,2024-01-18,2021-02-13,2021-02-18,ACTUAL,2024-01-18,2024-02-13,ACTUAL,,,,2024-01-18,2024-02-13,ACTUAL,2021-02-19,ACTUAL,2021-02-19,2024-01,2024-01-31,2023-01-18,ACTUAL,2023-01-18,2023-01-18,ACTUAL,2023-01-18,,INTERVENTIONAL,XTEND-Kids,Analysis was performed on full analysis set (FAS) which included all participants who took at least 1 dose of study intervention.,"Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A","A Phase 3 Open-label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Pediatric Patients <12 Years of Age With Severe Hemophilia A",COMPLETED,,PHASE3,74.0,ACTUAL,Sanofi,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 16:48:55.07151,2024-10-15 16:48:55.07151,INDUSTRY,,,,,,,2023,1.0
NCT03841565,,2019-02-13,,,2022-06-13,2019-02-13,2019-02-15,ACTUAL,,,,,,,2022-06-13,2022-06-15,ACTUAL,2020-08-07,ACTUAL,2020-08-07,2021-08,2021-08-31,2022-02-09,ACTUAL,2022-02-09,2022-02-09,ACTUAL,2022-02-09,,INTERVENTIONAL,,,"Daratumumab, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma",Phase II Trial of Daratumumab Retreatment in Patients With Relapsed Multiple Myeloma,WITHDRAWN,,PHASE2,0.0,ACTUAL,Academic and Community Cancer Research United,,1.0,,There are no patients enrolled on this study and all efforts are being discontinued.,,,,,f,t,f,,,f,,,,,,,,2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,OTHER,,,,,,,2022,0.0
NCT04566601,,2020-09-23,2023-12-08,,2024-01-22,2020-09-23,2020-09-28,ACTUAL,2024-01-22,2024-01-30,ACTUAL,,,,2024-01-22,2024-01-30,ACTUAL,2020-11-13,ACTUAL,2020-11-13,2024-01,2024-01-31,2023-01-25,ACTUAL,2023-01-25,2022-12-09,ACTUAL,2022-12-09,,INTERVENTIONAL,,Treated Set (TS) consisted of all patients who were randomised and that received at least one administration of trial medication.,A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder,"A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of 4 Oral Doses of BI 1358894 Once Daily Over 12 Week Treatment Period in Patients With Borderline Personality Disorder",COMPLETED,,PHASE2,390.0,ACTUAL,Boehringer Ingelheim,,5.0,,,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'.For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.",2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,INDUSTRY,,,,,,,2023,1.0
NCT04381169,,2020-05-02,,,2022-03-04,2020-05-05,2020-05-08,ACTUAL,,,,,,,2022-03-04,2022-03-21,ACTUAL,2020-05-28,ACTUAL,2020-05-28,2022-03,2022-03-31,2021-09-25,ACTUAL,2021-09-25,2021-09-25,ACTUAL,2021-09-25,,INTERVENTIONAL,WATERFALL,,Aggressive Versus Non-aggressive Goal-directed Fluid Resuscitation in Acute Pancreatitis,Effect of Early Weight-based Aggressive Versus Non-aggressive Goal-directed Fluid Resuscitation in the Early Phase of Acute Pancreatitis: an Open-label Multicenter Randomized-controlled Trial,TERMINATED,,PHASE3,249.0,ACTUAL,Hospital General Universitario de Alicante,,2.0,,Increased frequency of fluid overload on the aggressive fluid resuscitation arm of treatment,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2021,0.0
NCT05069935,,2021-09-10,,,2023-09-19,2021-10-01,2021-10-06,ACTUAL,,,,,,,2023-09-19,2023-09-21,ACTUAL,2021-10-15,ACTUAL,2021-10-15,2023-09,2023-09-30,2023-08-11,ACTUAL,2023-08-11,2023-08-11,ACTUAL,2023-08-11,,INTERVENTIONAL,,,FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors,"A Phase I, Open-Label, Multicenter Study of FT538 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,16.0,ACTUAL,Fate Therapeutics,,2.0,,This study was terminated by the Sponsor.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:48:55.07151,2024-10-15 16:48:55.07151,INDUSTRY,,,,,,,2023,0.0
NCT03548051,,2018-05-24,2021-12-30,,2022-04-28,2018-05-24,2018-06-06,ACTUAL,2022-04-28,2022-05-02,ACTUAL,,,,2022-04-28,2022-05-02,ACTUAL,2019-01-11,ACTUAL,2019-01-11,2021-08-18,2021-08-18,2021-01-13,ACTUAL,2021-01-13,2021-01-13,ACTUAL,2021-01-13,,INTERVENTIONAL,,,Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD),"Phase 1/2 Placebo Controlled, Partially-Blinded Clinical Trial to Assess the Safety and Efficacy of Microbial Restoration by Enema With Banked and Thawed Processed Stool in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD)",TERMINATED,,PHASE1/PHASE2,10.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,Low enrollment,f,,,,,t,f,,,f,,,,,,,,2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,NIH,,,,,,,2021,0.0
NCT03075527,,2017-03-02,2019-08-23,,2024-01-23,2017-03-06,2017-03-09,ACTUAL,2019-10-21,2019-11-12,ACTUAL,,,,2024-01-23,2024-01-25,ACTUAL,2017-04-10,ACTUAL,2017-04-10,2024-01,2024-01-31,2024-09-30,ESTIMATED,2024-09-30,2019-06-07,ACTUAL,2019-06-07,,INTERVENTIONAL,,,A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma,A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma,SUSPENDED,,PHASE2,19.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,Criteria not met for second stage at time of interim analysis,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,OTHER,,,,,,,2024,0.0
NCT02133885,,2014-05-06,,,2024-01-30,2014-05-06,2014-05-08,ESTIMATED,,,,,,,2024-01-30,2024-02-01,ACTUAL,2023-01-30,ESTIMATED,2023-01-30,2024-01,2024-01-31,2024-03,ESTIMATED,2024-03-31,2024-03,ESTIMATED,2024-03-31,,INTERVENTIONAL,,,Study 2: Effect of Minocycline Treatment on Drug-Resistant Hypertensive Patients,Angiotensin and Neuroimmune Activation in Hypertension,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Florida,,2.0,,This study was never started and no participants were enrolled.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2024,0.0
NCT04037865,,2019-07-26,2021-03-26,,2021-04-27,2019-07-26,2019-07-30,ACTUAL,2021-04-27,2021-05-18,ACTUAL,,,,2021-04-27,2021-05-18,ACTUAL,2019-08-19,ACTUAL,2019-08-19,2021-04,2021-04-30,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,The baseline analysis population included all participants enrolled in the study.,A Renal Impairment Study for PF-06651600,"A PHASE 1, NON-RANDOMIZED, OPEN LABEL, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF 06651600 IN PARTICIPANTS WITH RENAL IMPAIRMENT AND IN HEALTHY PARTICIPANTS WITH NORMAL RENAL FUNCTION",TERMINATED,,PHASE1,8.0,ACTUAL,Pfizer,"Since the study was terminated, the results of this study was not complete and the interpretation of the study results was limited.",4.0,,The study was terminated due to extensive Covid-19 delay.,f,,,,,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,INDUSTRY,,,,,,,2020,0.0
NCT02719015,,2016-03-21,,,2017-11-21,2016-03-23,2016-03-24,ESTIMATED,,,,,,,2017-11-21,2017-11-24,ACTUAL,2018-03,ESTIMATED,2018-03-31,2017-11,2017-11-30,2022-03,ESTIMATED,2022-03-31,2022-03,ESTIMATED,2022-03-31,,INTERVENTIONAL,,,Dose Escalation and Cohort Expansion of Safety and Tolerability Study of Intratumoral rAd.CD40L (ISF35) in Combination of Systemic Pembrolizumab in Patients With Refractory Metastatic Melanoma,Phase I/II Dose Escalation and Cohort Expansion of Safety and Tolerability Study of Intratumoral rAd.CD40L (ISF35) in Combination of Systemic Pembrolizumab in Patients With Refractory Metastatic Melanoma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,No IND Serial #,f,,,,f,t,f,,,,,,,,,,,2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,OTHER,,,,,,,2022,0.0
NCT04483414,,2020-07-20,,,2023-05-18,2020-07-20,2020-07-23,ACTUAL,,,,,,,2023-05-18,2023-05-19,ACTUAL,2021-03-19,ACTUAL,2021-03-19,2023-05,2023-05-31,2023-04-05,ACTUAL,2023-04-05,2023-04-05,ACTUAL,2023-04-05,,INTERVENTIONAL,,,68Ga PSMA-11 PET/CT in Recurrent Prostate Cancer,The Role of 68Gallium PSMA-11 in Biochemical Recurrence in Prostate Cancer and in Known Metastatic Prostate Cancer and in the Evaluation of Treatment Response After Salvage Therapy,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Texas Southwestern Medical Center,,1.0,,Study was closed since no participants were enrolled.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,OTHER,,,,,,,2023,0.0
NCT03383887,,2017-12-13,2020-01-22,,2020-02-11,2017-12-26,2017-12-27,ACTUAL,2020-01-22,2020-02-05,ACTUAL,,,,2020-02-11,2020-02-25,ACTUAL,2017-12-13,ACTUAL,2017-12-13,2020-02,2020-02-29,2020-01-20,ACTUAL,2020-01-20,2020-01-20,ACTUAL,2020-01-20,,INTERVENTIONAL,OSAstimD,,DAW1033D in Obstructive Sleep Apnea,Effect of DAW1033D on Obstructive Sleep Apnea and Its Phenotypic Traits,COMPLETED,,PHASE1/PHASE2,11.0,ACTUAL,Brigham and Women's Hospital,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 16:48:55.07151,2024-10-15 16:48:55.07151,OTHER,,,,,,,2020,1.0
NCT04399395,,2020-05-19,,,2021-02-25,2020-05-21,2020-05-22,ACTUAL,,,,,,,2021-02-25,2021-03-01,ACTUAL,2020-11-01,ACTUAL,2020-11-01,2021-02,2021-02-28,2022-12-31,ESTIMATED,2022-12-31,2022-09-30,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,Naltrexone/Bupropion (Mysimba) to Optimize Weight Outcomes After Obesity Surgery,Treatment With Naltrexone/Buprpion (Mysimba) to Optimize Weight Outcomes After Bariatric Surgery,WITHDRAWN,,PHASE4,0.0,ACTUAL,Oslo University Hospital,,2.0,,Covid-pandemic,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2022,0.0
NCT04247594,,2020-01-21,2023-01-10,,2023-11-01,2020-01-28,2020-01-30,ACTUAL,2023-11-01,2023-11-21,ACTUAL,,,,2023-11-01,2023-11-21,ACTUAL,2020-01-09,ACTUAL,2020-01-09,2023-10,2023-10-31,2021-06-08,ACTUAL,2021-06-08,2021-06-08,ACTUAL,2021-06-08,,INTERVENTIONAL,,Subjects treated with at least one dose of Voxelotor,"Dose Escalation Study to Evaluate the Safety, Tolerability, PK and PD of Voxelotor in Patients With SCD","A Phase 2, Open Label, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Voxelotor in Patients With Sickle Cell Disease",TERMINATED,,PHASE2,6.0,ACTUAL,Pfizer,,4.0,,Data will not inform further development of Voxelotor,f,,,,,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,INDUSTRY,,,,,,,2021,0.0
NCT02915263,,2016-08-08,2023-07-10,,2024-04-13,2016-09-23,2016-09-27,ESTIMATED,2023-08-20,2023-09-13,ACTUAL,,,,2024-04-13,2024-05-07,ACTUAL,2017-09-11,ACTUAL,2017-09-11,2024-04,2024-04-30,2022-02-01,ACTUAL,2022-02-01,2022-02-01,ACTUAL,2022-02-01,,INTERVENTIONAL,,"A total of 13 participants were enrolled before COVID-19 pandemic shut down research activities. A total of 8 participants were able to complete the study, 5 stopped mid-study due to the COVID shutdown.",The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes,"A Double-Blind, Randomized, Placebo-Controlled Trial To Evaluate The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes",TERMINATED,,PHASE2,13.0,ACTUAL,Beth Israel Deaconess Medical Center,,2.0,,Funding withdrawn in the midst of the COVID pandemic,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2022,0.0
NCT03944707,,2019-05-02,2021-03-30,,2021-10-07,2019-05-08,2019-05-09,ACTUAL,2021-03-30,2021-04-27,ACTUAL,,,,2021-10-07,2021-10-11,ACTUAL,2019-07-18,ACTUAL,2019-07-18,2021-10,2021-10-31,2020-04-27,ACTUAL,2020-04-27,2020-04-27,ACTUAL,2020-04-27,,INTERVENTIONAL,,,Study of Efficacy and Safety of LOU064 in Inadequately Controlled Asthma Patients,"A Randomized, Subject- and Investigator-blinded, Placebo-controlled Study to Assess the Efficacy and Safety of LOU064 in Patients With Inadequately Controlled Asthma",TERMINATED,,PHASE2,76.0,ACTUAL,Novartis,,2.0,,Company decision,,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,INDUSTRY,,,,,,,2020,0.0
NCT02219490,,2014-08-15,2022-03-11,,2022-06-27,2014-08-15,2014-08-19,ESTIMATED,2022-06-27,2023-04-07,ACTUAL,,,,2022-06-27,2023-04-07,ACTUAL,2014-10-30,ACTUAL,2014-10-30,2022-06,2022-06-30,2021-05-13,ACTUAL,2021-05-13,2021-05-13,ACTUAL,2021-05-13,,INTERVENTIONAL,TOPAZ-I,Safety population: All participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug,A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection,"An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes With ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I)",COMPLETED,,PHASE3,1596.0,ACTUAL,AbbVie,,1.0,,,f,,,,t,f,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications",2024-10-15 16:48:55.07151,2024-10-15 16:48:55.07151,INDUSTRY,,,,,,,2021,1.0
NCT03084861,,2017-03-08,,,2020-10-23,2017-03-14,2017-03-21,ACTUAL,,,,,,,2020-10-23,2020-10-27,ACTUAL,2017-02-24,ACTUAL,2017-02-24,2020-10,2020-10-31,2020-03-12,ACTUAL,2020-03-12,2020-03-12,ACTUAL,2020-03-12,,INTERVENTIONAL,,,A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy,"A Multicenter, Randomized, Open-label, Two-arms Phase I/II Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy",TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,Banc de Sang i Teixits,,2.0,,Low recruitment. No safety issue associated.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 16:48:55.07151,2024-10-15 16:48:55.07151,OTHER,,,,,,,2020,0.0
NCT03824847,,2019-01-29,,,2022-11-01,2019-01-29,2019-01-31,ACTUAL,,,,,,,2022-11-01,2022-11-04,ACTUAL,2023-06-01,ESTIMATED,2023-06-01,2022-11,2022-11-30,2024-09-01,ESTIMATED,2024-09-01,2024-03-01,ESTIMATED,2024-03-01,,INTERVENTIONAL,,,Immunomodulatory Effect of Macrolides in Naturally Occurring Influenza Virus Infections in the Community,Immunomodulatory Effect of Macrolides in Naturally Occurring Influenza Virus Infections in the Community,SUSPENDED,,PHASE4,100.0,ESTIMATED,The University of Hong Kong,,2.0,,Community recruitment suspended due to COVID-19,f,,,,f,f,f,,,,,,,,,,,2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,OTHER,,,,,,,2024,0.0
NCT04518319,,2020-08-13,,,2023-04-14,2020-08-18,2020-08-19,ACTUAL,,,,,,,2023-04-14,2023-04-18,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2023-04,2023-04-30,2024-11,ESTIMATED,2024-11-30,2024-11,ESTIMATED,2024-11-30,,INTERVENTIONAL,,,Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome,Clinical Comprehensive Intervention on Cognitive Impairment of Schizophrenia Patients With Metabolic Syndrome,SUSPENDED,,PHASE2,120.0,ESTIMATED,Shanghai Mental Health Center,,4.0,,The COVID-19 affects the recruitment of patients.,f,,,,,f,f,,,,,,,,,,,2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,OTHER,,,,,,,2024,0.0
NCT04057807,,2019-08-13,2023-07-27,,2024-02-01,2019-08-13,2019-08-15,ACTUAL,2023-10-17,2023-10-18,ACTUAL,,,,2024-02-01,2024-02-05,ACTUAL,2018-04-15,ACTUAL,2018-04-15,2024-02,2024-02-29,2022-07-27,ACTUAL,2022-07-27,2022-07-27,ACTUAL,2022-07-27,,INTERVENTIONAL,,,Peripheral Benzodiazepine Receptors (PBR28) Brain PET Imaging With Lipopolysaccharide Challenge for the Study of Microglia Function in Alzheimer's Disease,PBR28 Brain Positron Emission Tomography Imaging With Lipopolysaccharide (LPS) Challenge for the Study of Microglia Function in Alzheimer's Disease,COMPLETED,,EARLY_PHASE1,18.0,ACTUAL,Yale University,,1.0,,,f,,,,,t,f,,,t,,,,,,,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2022,1.0
NCT03729401,,2018-10-15,,,2024-01-12,2018-11-01,2018-11-02,ACTUAL,,,,,,,2024-01-12,2024-01-16,ACTUAL,2019-08-22,ACTUAL,2019-08-22,2024-01,2024-01-31,2024-09,ESTIMATED,2024-09-30,2024-03,ESTIMATED,2024-03-31,,INTERVENTIONAL,RAPID EXTEND,,Personalization of Long-Term Antiplatelet Therapy - RAPID EXTEND,Personalization of Long-Term Antiplatelet Therapy Using a Novel Combined Demographic/Pharmacogenomic Strategy - The RAPID EXTEND Randomized Study,SUSPENDED,,PHASE4,390.0,ESTIMATED,Ottawa Heart Institute Research Corporation,,3.0,,Testing supplies unavailable.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,OTHER,,,,,,,2024,0.0
NCT03691974,,2018-09-12,2023-01-24,2021-01-28,2023-02-27,2018-09-28,2018-10-02,ACTUAL,2023-02-27,2023-03-01,ACTUAL,,2023-03-01,ACTUAL,2023-02-27,2023-03-01,ACTUAL,2018-10-15,ACTUAL,2018-10-15,2023-02,2023-02-28,2021-01-07,ACTUAL,2021-01-07,2020-01-30,ACTUAL,2020-01-30,,INTERVENTIONAL,,,Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee,"A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee",COMPLETED,,PHASE2,180.0,ACTUAL,Regeneron Pharmaceuticals,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,INDUSTRY,,,,,,,2021,1.0
NCT00946192,,2009-07-22,2020-02-15,,2021-06-04,2009-07-23,2009-07-24,ESTIMATED,2020-03-12,2020-03-18,ACTUAL,,,,2021-06-04,2021-06-11,ACTUAL,2009-05,ACTUAL,2009-05-31,2021-06,2021-06-30,2021-04,ACTUAL,2021-04-30,2020-02,ACTUAL,2020-02-29,,INTERVENTIONAL,,Athletes with amenorrhea,Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes,Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes,COMPLETED,,PHASE3,121.0,ACTUAL,Massachusetts General Hospital,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 16:48:55.07151,2024-10-15 16:48:55.07151,OTHER,,,,,,,2021,1.0
NCT01994265,,2013-11-09,,,2021-09-28,2013-11-20,2013-11-25,ESTIMATED,,,,,,,2021-09-28,2021-09-29,ACTUAL,2014-11-07,,2014-11-07,2021-09,2021-09-30,2021-03-09,ACTUAL,2021-03-09,2021-03-09,ACTUAL,2021-03-09,,INTERVENTIONAL,GIRAF,,Cognitive Impairment Related to Atrial Fibrillation Prevention Trial,Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin,COMPLETED,,PHASE4,200.0,ACTUAL,University of Sao Paulo,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2021,1.0
NCT05290740,,2022-02-22,,,2023-06-15,2022-03-11,2022-03-22,ACTUAL,,,,,,,2023-06-15,2023-06-18,ACTUAL,2022-03-11,ACTUAL,2022-03-11,2023-06,2023-06-30,2022-07-25,ACTUAL,2022-07-25,2022-07-25,ACTUAL,2022-07-25,,INTERVENTIONAL,,,Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery,"Comparison of Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery: A Randomized, Controlled Trial",COMPLETED,,PHASE4,158.0,ACTUAL,Kasr El Aini Hospital,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,protocol and data of this research could be available from the PI upon reasonable request,2024-10-15 16:48:55.07151,2024-10-15 16:48:55.07151,OTHER,,,,,,,2022,0.0
NCT03948334,,2019-04-04,2021-04-07,,2021-10-07,2019-05-10,2019-05-13,ACTUAL,2021-06-29,2021-07-20,ACTUAL,,,,2021-10-07,2021-10-08,ACTUAL,2019-04-04,ACTUAL,2019-04-04,2021-10,2021-10-31,2020-08-25,ACTUAL,2020-08-25,2020-07-23,ACTUAL,2020-07-23,,INTERVENTIONAL,ZESTExt,,A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients,"A Randomized, Double Blind, Multicenter Extension to CZPL389A2203 Dose-ranging Study to Assess the Short-term and Long-term Safety and Efficacy of Oral ZPL389 With Concomitant Use of TCS and/or TCI in Adult Patients With Atopic Dermatitis.",TERMINATED,,PHASE2,123.0,ACTUAL,Novartis,,2.0,,Core terminated due to lack of efficacy,f,,,,t,t,f,,,,,,,,,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,INDUSTRY,,,,,,,2020,0.0
NCT03102242,,2017-03-27,2023-04-03,,2023-04-28,2017-03-30,2017-04-05,ACTUAL,2023-04-28,2023-05-24,ACTUAL,,,,2023-04-28,2023-05-24,ACTUAL,2017-11-01,ACTUAL,2017-11-01,2023-04,2023-04-30,2022-10-01,ACTUAL,2022-10-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,,,Atezolizumab Immunotherapy in Patients With Advanced NSCLC,Phase II Trial of Induction Immunotherapy With Atezolizumab for Patients With Unresectable Stage IIIA and IIIB NSCLC Eligible for Chemoradiotherapy With Curative Intent.,COMPLETED,,PHASE2,64.0,ACTUAL,"Alliance Foundation Trials, LLC.",,1.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 16:48:55.07151,2024-10-15 16:48:55.07151,OTHER,,,,,,,2022,1.0
NCT04386447,,2020-05-12,,,2021-01-12,2020-05-12,2020-05-13,ACTUAL,,,,,,,2021-01-12,2021-01-14,ACTUAL,2020-09-01,ESTIMATED,2020-09-01,2021-01,2021-01-31,2020-12-31,ESTIMATED,2020-12-31,2020-10-31,ESTIMATED,2020-10-31,,INTERVENTIONAL,OsCOVID19,,Phase II RCT to Assess Efficacy of Intravenous Administration of Oxytocin in Patients Affected by COVID-19,"Phase II, Multicenter, Open-label, Rct With an Adaptive Design, to Assess Efficacy of Intravenous Administration of Oxytocin in Hospitalized Patients Affected by COVID-19",WITHDRAWN,,PHASE2,0.0,ACTUAL,Azienda Ospedaliero-Universitaria di Parma,,3.0,,The study was not approved by the Italian Medicines Agency (AIFA).,f,,,,t,f,f,,,,,,,,,,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,OTHER,,,,,,,2020,0.0
NCT03033732,,2017-01-10,,,2021-06-11,2017-01-26,2017-01-27,ESTIMATED,,,,,,,2021-06-11,2021-06-16,ACTUAL,2017-10-02,ACTUAL,2017-10-02,2021-06,2021-06-30,2020-12-31,ACTUAL,2020-12-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,OPTIMA,,A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse,Optimizing Patient Centered-Care: A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse (OPTIMA Trial),COMPLETED,,PHASE4,272.0,ACTUAL,Canadian Research Initiative in Substance Misuse,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 16:48:55.07151,2024-10-15 16:48:55.07151,OTHER,,,,,,,2020,1.0
NCT03059355,,2017-02-06,2022-09-28,,2022-10-13,2017-02-15,2017-02-23,ACTUAL,2022-10-13,2022-11-08,ACTUAL,,,,2022-10-13,2022-11-08,ACTUAL,2018-04-12,ACTUAL,2018-04-12,2022-10,2022-10-31,2021-02-11,ACTUAL,2021-02-11,2020-03-23,ACTUAL,2020-03-23,,INTERVENTIONAL,CERES,Randomized phase of the study was terminated after only 2 participants. No subjects were allocated to Group A or Group C in the randomized phase of the trial.,Infusion of Umbilical Cord Versus Bone Marrow Derived Mesenchymal Stem Cells to Evaluate Cytokine Suppression.,"A Phase I/II, Randomized, Placebo-controlled Comparative Study to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Bone Marrow (BM) Derived MSCs to Evaluate Cytokine Suppression in Patients With Chronic Inflammation Due to Metabolic Syndrome.",TERMINATED,,PHASE1/PHASE2,14.0,ACTUAL,University of Miami,"Funding timeline was not met due to the coronavirus disease 2019 (COVID-19) pandemic. No additional funding was provided, therefore the study had to be terminated early.",7.0,,COVID-19 Pandemic and lack of funding,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,OTHER,,,,,,,2021,0.0
NCT03434158,,2018-01-26,,,2022-11-02,2018-02-14,2018-02-15,ACTUAL,,,,,,,2022-11-02,2022-11-03,ACTUAL,2018-02-06,ACTUAL,2018-02-06,2022-10,2022-10-31,2022-05-12,ACTUAL,2022-05-12,2022-05-12,ACTUAL,2022-05-12,,INTERVENTIONAL,IMANOL,,Olaparib Maintenance in Patients With MCRPC After Docetaxel Treatment Reaching Partial or Stable Response (IMANOL),Phase II Trial Evaluating Olaparib Maintenance in Patients With MCRPC After Docetaxel Treatment Reaching Partial or Stable Response.,COMPLETED,,PHASE2,16.0,ACTUAL,Spanish Oncology Genito-Urinary Group,,1.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2022,1.0
NCT01594229,,2012-04-20,,,2021-07-29,2012-05-07,2012-05-09,ESTIMATED,,,,,,,2021-07-29,2021-08-02,ACTUAL,2012-05-21,ACTUAL,2012-05-21,2021-07,2021-07-31,2020-07-14,ACTUAL,2020-07-14,2020-07-14,ACTUAL,2020-07-14,,INTERVENTIONAL,,,A Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Combination With Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma,A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Combination With Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma,COMPLETED,,PHASE1,60.0,ACTUAL,AbbVie,,1.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,INDUSTRY,,,,,,,2020,1.0
NCT02432417,,2015-04-09,,,2023-11-14,2015-04-28,2015-05-04,ESTIMATED,,,,,,,2023-11-14,2023-11-18,ACTUAL,2023-11-10,ACTUAL,2023-11-10,2023-11,2023-11-30,2023-11-10,ACTUAL,2023-11-10,2023-11-10,ACTUAL,2023-11-10,,INTERVENTIONAL,,,"The Addition of Chloroquine to Chemoradiation for Glioblastoma,","A Phase II Randomized Controlled Trial for the Addition of Chloroquine, an Autophagy Inhibitor, to Concurrent Chemoradiation for Newly Diagnosed Glioblastoma",WITHDRAWN,,PHASE2,0.0,ACTUAL,Maastricht Radiation Oncology,,2.0,,The study was withdrawn due to a lack of funding. The researchers were unable to secure the necessary financial support to continue and complete the trial.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2023,0.0
NCT05132803,,2021-11-02,,,2022-11-29,2021-11-12,2021-11-24,ACTUAL,,,,,,,2022-11-29,2022-12-01,ACTUAL,2021-08,ESTIMATED,2021-08-31,2022-11,2022-11-30,2022-01-18,ACTUAL,2022-01-18,2022-01-18,ACTUAL,2022-01-18,,INTERVENTIONAL,,,TA-CIN Vaccine With Anti-PD-1 Therapy in Recurrent HPV16-associated Cancers,A Feasibility Trial to Assess Intratumoral Injection of TA-CIN With Anti-PD-1 Therapy for Recurrent HPV16-associated Cancers,WITHDRAWN,,PHASE1,0.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,The study team decided not to move forward with the study.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,OTHER,,,,,,,2022,0.0
NCT04091087,,2019-09-13,2022-04-01,,2022-04-01,2019-09-13,2019-09-16,ACTUAL,2022-04-01,2022-05-02,ACTUAL,,,,2022-04-01,2022-05-02,ACTUAL,2020-06-26,ACTUAL,2020-06-26,2022-04,2022-04-30,2021-10-19,ACTUAL,2021-10-19,2021-10-19,ACTUAL,2021-10-19,,INTERVENTIONAL,,Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized.,Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis,"A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Local Tolerability of Crisaborole Ointment, 2%, in Adult Participants With Stasis Dermatitis Without Active Skin Ulceration",COMPLETED,,PHASE2,66.0,ACTUAL,Pfizer,,2.0,,,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,INDUSTRY,,,,,,,2021,1.0
NCT02999906,,2016-12-19,,,2017-10-31,2016-12-19,2016-12-21,ESTIMATED,,,,,,,2017-10-31,2017-11-01,ACTUAL,2017-10,ESTIMATED,2017-10-31,2017-10,2017-10-31,2022-06,ESTIMATED,2022-06-30,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,"Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension",WITHDRAWN,,PHASE3,0.0,ACTUAL,United Therapeutics,,2.0,,For business reasons.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,INDUSTRY,,,,,,,2022,0.0
NCT04325061,,2020-03-25,,,2021-02-02,2020-03-26,2020-03-27,ACTUAL,,,,,,,2021-02-02,2021-02-03,ACTUAL,2020-04-03,ACTUAL,2020-04-03,2021-02,2021-02-28,2020-06-19,ACTUAL,2020-06-19,2020-06-19,ACTUAL,2020-06-19,,INTERVENTIONAL,DEXA-COVID19,,Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19,Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19,TERMINATED,,PHASE4,19.0,ACTUAL,Dr. Negrin University Hospital,,2.0,,Lack of enrollment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,OTHER,,,,,,,2020,0.0
NCT04546828,,2020-09-04,,,2022-06-13,2020-09-04,2020-09-14,ACTUAL,,,,,,,2022-06-13,2022-06-15,ACTUAL,2021-02-01,ESTIMATED,2021-02-01,2022-06,2022-06-30,2021-08-18,ACTUAL,2021-08-18,2021-08-18,ACTUAL,2021-08-18,,INTERVENTIONAL,,,"A Single-arm Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk IHCC in Korea","A Single-arm Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma in Korea",WITHDRAWN,,PHASE2,0.0,ACTUAL,Samsung Medical Center,,1.0,,problem of sponsor,f,,,,f,f,f,,,,,,,,,,,2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,OTHER,,,,,,,2021,0.0
NCT04303572,,2019-10-31,2023-01-25,,2023-01-25,2020-03-10,2020-03-11,ACTUAL,2023-01-25,2023-02-21,ACTUAL,,,,2023-01-25,2023-02-21,ACTUAL,2021-11-01,ACTUAL,2021-11-01,2023-01,2023-01-31,2022-06-27,ACTUAL,2022-06-27,2022-06-27,ACTUAL,2022-06-27,,INTERVENTIONAL,,,The Hemophilia Inhibitor Eradication Trial,"Phase III Multi-Center, Randomized, Controlled Inhibitor Eradication Trial, Comparing Eloctate Immune Tolerance Induction (ITI) Plus Emicizumab vs. Eloctate ITI Alone to Eradicate Inhibitor Formation in Severe Hemophilia A",TERMINATED,,PHASE3,1.0,ACTUAL,University of Pittsburgh,,2.0,,"The INHIBIT Trials IDSMB, in a letter dated 05-18-22, recommended, given the slow enrollment, that the INHIBIT Trials be discontinued due to futility.",f,,,,t,t,f,,,f,,,Within one year of trial completion.,Access will be determined by the Study Team.,,YES,A biologic specimen and data repository for this trial will be available at the Graduate School of Public Health (GSPH) Data Center repository for investigators who make formal application request and is formally approved by the Coordinating Center (Pitt) and Data Center (GSPH).,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2022,0.0
NCT03902509,,2019-04-02,,,2022-06-13,2019-04-02,2019-04-04,ACTUAL,,,,,,,2022-06-13,2022-06-15,ACTUAL,2019-05-24,ACTUAL,2019-05-24,2022-06,2022-06-30,2022-06-13,ACTUAL,2022-06-13,2022-06-13,ACTUAL,2022-06-13,,INTERVENTIONAL,,,A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.,"A Randomized, Controlled, Multi-site Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.",TERMINATED,,PHASE2,126.0,ACTUAL,"Beijing Continent Pharmaceutical Co, Ltd.",,2.0,,The protocol revision is needed.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,INDUSTRY,,,,,,,2022,0.0
NCT03127345,,2017-04-07,,,2019-09-12,2017-04-20,2017-04-25,ACTUAL,,,,,,,2019-09-12,2019-09-16,ACTUAL,2019-09,ESTIMATED,2019-09-30,2019-09,2019-09-30,2023-09,ESTIMATED,2023-09-30,2023-09,ESTIMATED,2023-09-30,,INTERVENTIONAL,,,Omega 3 Fatty Acid Treatment for Pediatric Musculoskeletal Health,Omega 3 Fatty Acid Treatment for Pediatric Musculoskeletal Health,WITHDRAWN,,PHASE2,0.0,ACTUAL,Boston Children's Hospital,,2.0,,Lack of funding,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 16:48:55.07151,2024-10-15 16:48:55.07151,OTHER,,,,,,,2023,0.0
NCT05303909,,2022-03-13,,,2024-05-13,2022-03-21,2022-03-31,ACTUAL,,,,,,,2024-05-13,2024-05-16,ACTUAL,2022-05-11,ACTUAL,2022-05-11,2024-05,2024-05-31,2024-05-13,ACTUAL,2024-05-13,2024-05-13,ACTUAL,2024-05-13,,INTERVENTIONAL,,,The Immunostimulatory Effects of Gentamicin,The Immunostimulatory Effects of Gentamicin: Translating Aminoglycoside Antibiotics Into Antiviral Therapeutics for Pandemic Response (Part B),TERMINATED,,PHASE2,33.0,ACTUAL,Singapore General Hospital,,2.0,,slow recruitment due to COVID19,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,OTHER,,,,,,,2024,0.0
NCT04633447,,2020-11-06,,,2024-06-21,2020-11-17,2020-11-18,ACTUAL,,,,,,,2024-06-21,2024-06-24,ACTUAL,2020-12-10,ACTUAL,2020-12-10,2024-06,2024-06-30,2024-05-22,ACTUAL,2024-05-22,2024-05-22,ACTUAL,2024-05-22,,INTERVENTIONAL,THEIA,,A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis,"A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis",TERMINATED,,PHASE2,53.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,The study primary endpoint was not met.,f,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,INDUSTRY,,,,,,,2024,0.0
NCT04294277,,2020-03-02,,,2023-02-13,2020-03-03,2020-03-04,ACTUAL,,,,,,,2023-02-13,2023-02-14,ACTUAL,2020-07-13,ACTUAL,2020-07-13,2023-02,2023-02-28,2022-11-15,ACTUAL,2022-11-15,2021-11-15,ACTUAL,2021-11-15,,INTERVENTIONAL,PEGASUS,,Safety and Efficacy of Pemigatinib in Patients With High-risk Urothelial Cancer After Radical Surgery,"Open-label, Single-arm, Phase II Study, Evaluating Safety and Efficacy of INCB054828 (Pemigatinib) as Adjuvant Therapy for Molecularly-selected, High-risk Patients With Urothelial Carcinoma Who Have Received Radical Surgery",TERMINATED,,PHASE2,2.0,ACTUAL,European Association of Urology Research Foundation,,1.0,,Screening success and patient recruitment was much lower than projected and a clinical/scientific interpretation will not be possible.,f,,,,t,f,f,,,,,,,,,,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,OTHER,,,,,,,2022,0.0
NCT05413902,,2022-05-05,,,2022-06-08,2022-06-08,2022-06-10,ACTUAL,,,,,,,2022-06-08,2022-06-10,ACTUAL,2021-04-05,ACTUAL,2021-04-05,2022-06,2022-06-30,2022-03-23,ACTUAL,2022-03-23,2022-01-28,ACTUAL,2022-01-28,,INTERVENTIONAL,,,Multi-Modal Anesthesia Protocol in Pain Management of Patients Undergoing Posterior Lumbar Spinal Fusion Surgery,Efficiency of Multi-Modal Anesthesia (MMA) Protocol in Pain Control and Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion Surgery,COMPLETED,,PHASE4,100.0,ACTUAL,University of Puerto Rico,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,"There is no plan to make individual participant data (IPD) available to other researchers. However, data could be shared upon individual researchers' reasonable request.",2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,OTHER,,,,,,,2022,1.0
NCT04004325,,2019-06-10,,2021-01-15,2022-03-14,2019-06-27,2019-07-02,ACTUAL,,,,2021-01-15,2021-01-20,ACTUAL,2022-03-14,2022-03-16,ACTUAL,2019-05-17,ACTUAL,2019-05-17,2022-03,2022-03-31,2020-01-20,ACTUAL,2020-01-20,2020-01-20,ACTUAL,2020-01-20,,INTERVENTIONAL,,,A Study of FT 4101 in Overweight/Obese Participants With Non-alcoholic Steatohepatitis,"A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability and Efficacy of FT-4101 in Overweight/Obese Subjects With NASH",TERMINATED,,PHASE1/PHASE2,14.0,ACTUAL,Novo Nordisk A/S,,2.0,,sponsor decision,f,,,,,t,f,,,,,,,,,,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,INDUSTRY,,,,,,,2020,0.0
NCT03924245,,2019-04-18,,,2022-03-23,2019-04-18,2019-04-23,ACTUAL,,,,,,,2022-03-23,2022-04-04,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2022-03,2022-03-31,2022-02-04,ACTUAL,2022-02-04,2022-02-04,ACTUAL,2022-02-04,,INTERVENTIONAL,,,"Olaparib and Entinostat in Patients With Recurrent, Platinum-Refractory, Resistant Ovarian, Primary Peritoneal, Fallopian Tube Cancers","A Phase I/II Study of Olaparib With Entinostat in the Treatment of Recurrent, Platinum-Refractory or Resistant, Homologous Recombination Repair Proficient Ovarian, Primary Peritoneal, and Fallopian Tube Cancers",TERMINATED,,PHASE1,3.0,ACTUAL,Vanderbilt-Ingram Cancer Center,,1.0,,Change in participant landscape and other treatment availability,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 16:48:55.07151,2024-10-15 16:48:55.07151,OTHER,,,,,,,2022,0.0
NCT03805178,,2019-01-14,,,2019-04-30,2019-01-14,2019-01-15,ACTUAL,,,,,,,2019-04-30,2019-05-02,ACTUAL,2019-05-01,ESTIMATED,2019-05-01,2019-04,2019-04-30,2020-10-30,ESTIMATED,2020-10-30,2020-08-01,ESTIMATED,2020-08-01,,INTERVENTIONAL,,,Lung Transplant Plasmapheresis/Belatacept/Carfilzomib for Antibody Mediated Rejection and Desensitization,Lung Transplant Plasmapheresis (PLEX)/Belatacept/Carfilzomib Protocol for Treatment of Antibody Mediated Rejection (AMR) and Desensitization,WITHDRAWN,,PHASE2,0.0,ACTUAL,Duke University,,2.0,,Not activated at Duke,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,OTHER,,,,,,,2020,0.0
NCT04385264,,2020-04-21,,,2021-05-06,2020-05-11,2020-05-12,ACTUAL,,,,,,,2021-05-06,2021-05-11,ACTUAL,2022-01,ESTIMATED,2022-01-31,2021-05,2021-05-31,2022-12,ESTIMATED,2022-12-31,2022-08,ESTIMATED,2022-08-31,,INTERVENTIONAL,#StayHome,,#StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19,"#StayHome: Efficacy of Early Hydroxychloroquine in Outpatients to Reduce Secondary Hospitalisation and Household Transmission of COVID-19 in Switzerland: A Double-blind, Randomised, Placebo-controlled Trial",SUSPENDED,,PHASE2/PHASE3,800.0,ESTIMATED,"Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland",,2.0,,Sufficient number of subjects would probably not reach,f,,,,t,f,f,,,f,,,Unknown (determined by the evolution of the epidemic),On request by researchers agreeing to use the data for it intended purpose: i.e. to further knowledge of the efficacy and safety of HCQ in COVID-19 and to better understand the disease.,,YES,"The aim is to share data, protocols, information sheets, CRFs and analytical code as soon as possible. Data will first be cleaned and anonymised and then subjected to rigorous assessments to secure patient privacy and analytical robustness according to the FAIR principles.",2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,OTHER,,,,,,,2022,0.0
NCT03105128,,2017-04-04,2022-03-31,2021-07-16,2022-06-09,2017-04-04,2017-04-07,ACTUAL,2022-06-09,2022-07-06,ACTUAL,2022-06-09,2022-07-06,ACTUAL,2022-06-09,2022-07-06,ACTUAL,2017-05-10,ACTUAL,2017-05-10,2022-06,2022-06-30,2021-04-14,ACTUAL,2021-04-14,2020-11-09,ACTUAL,2020-11-09,,INTERVENTIONAL,,Consists of all subjects who received at least 1 dose of study medication.,A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease",COMPLETED,,PHASE3,931.0,ACTUAL,AbbVie,,6.0,,,t,,,,t,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,INDUSTRY,,NCT03914261,NO_LONGER_AVAILABLE,,,,2021,1.0
NCT03523091,,2018-05-01,2021-10-11,,2022-01-14,2018-05-01,2018-05-14,ACTUAL,2022-01-14,2022-02-10,ACTUAL,,,,2022-01-14,2022-02-10,ACTUAL,2018-08-08,ACTUAL,2018-08-08,2022-01,2022-01-31,2020-09-01,ACTUAL,2020-09-01,2020-09-01,ACTUAL,2020-09-01,,INTERVENTIONAL,,"Of the initial 6 subjects consented, 1 subject was randomized to the 3 injection site arm and 5 were randomized to the 10 injection site arm.",OnabotulinumtoxinA Bladder Injection Study,Is Less More? Does Decreasing OnabotulinumtoxinA Injection Sites in the Bladder Increase Patient Satisfaction While Maintaining Efficacy?,TERMINATED,,PHASE4,6.0,ACTUAL,William Beaumont Hospitals,,2.0,,Lack of enrollment,f,,,,f,t,f,,,t,,,,,,NO,Participant data will not be available,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,OTHER,,,,,,,2020,0.0
NCT03120130,,2017-03-29,,,2019-10-11,2017-04-18,2017-04-19,ACTUAL,,,,,,,2019-10-11,2019-10-14,ACTUAL,2021-02-15,ESTIMATED,2021-02-15,2019-06,2019-06-30,2022-05-22,ESTIMATED,2022-05-22,2021-08-20,ESTIMATED,2021-08-20,,INTERVENTIONAL,Amblyomin-X,,Study of Amblyomin-X in Advanced Solid Tumor,Phase I Study (First in Humans) of the Amblyomin-X in the Treatment of Patients With Advanced Solid Tumors Refractory or Without Indication / Access to Standard Treatment,SUSPENDED,,PHASE1,24.0,ESTIMATED,União Química Farmacêutica Nacional S/A,,6.0,,Delay in the R \& D stage,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,INDUSTRY,,,,,,,2022,0.0
NCT04700176,,2021-01-04,,,2024-01-08,2021-01-05,2021-01-07,ACTUAL,,,,,,,2024-01-08,2024-01-10,ACTUAL,2022-05-02,ACTUAL,2022-05-02,2024-01,2024-01-31,2023-11-15,ACTUAL,2023-11-15,2023-11-15,ACTUAL,2023-11-15,,INTERVENTIONAL,,,"A Study of Daratumumab With Pomalidomide, Dexamethasone, and All-Transretinoic Acid in Patients With Multiple Myeloma",A Multi-Center Phase 2 Study of Daratumumab With Pomalidomide and Dexamethasone in Combination With All-Transretinoic Acid in Patients With Multiple Myeloma Previously Exposed to Daratumumab-Based Regimens,TERMINATED,,PHASE2,1.0,ACTUAL,Hackensack Meridian Health,,2.0,,Low Accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,OTHER,,,,,,,2023,0.0
NCT04362124,,2020-04-21,,,2020-11-24,2020-04-23,2020-04-24,ACTUAL,,,,,,,2020-11-24,2020-11-27,ACTUAL,2020-08,ESTIMATED,2020-08-31,2020-04,2020-04-30,2021-11,ESTIMATED,2021-11-30,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of COVID-19 Infection.,"Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of SARS-COV-2 Infection in Medellín, Colombia, 2020",WITHDRAWN,,PHASE3,0.0,ACTUAL,Universidad de Antioquia,,2.0,,Study was stopped because Principal Investigator did not obtain sponsorship to carry it out,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,OTHER,,,,,,,2021,0.0
NCT04303559,,2020-03-02,2023-01-17,,2023-03-17,2020-03-10,2020-03-11,ACTUAL,2023-03-17,2023-04-11,ACTUAL,,,,2023-03-17,2023-04-11,ACTUAL,2021-10-11,ACTUAL,2021-10-11,2023-03,2023-03-31,2022-06-16,ACTUAL,2022-06-16,2022-04-06,ACTUAL,2022-04-06,,INTERVENTIONAL,,,The Hemophilia Inhibitor Prevention Trial,"Multicenter, Randomized Phase III Inhibitor Prevention Trial, Comparing Eloctate vs. Emicizumab to Prevent Inhibitor Formation in Severe Hemophilia A",TERMINATED,,PHASE3,1.0,ACTUAL,University of Pittsburgh,,2.0,,"The INHIBIT Trials IDSMB, in a letter dated 05-18-22, recommended, given the slow enrollment, that the INHIBIT Trials be discontinued due to futility.",f,,,,t,t,f,,,f,,,Within one year of trial completion.,Access will be determined by Study Team.,,YES,A biologic specimen and data repository for this trial will be available at the Graduate School of Public Health (GSPH) Data Center repository for investigators who make formal application request and is formally approved by the Coordinating Center (Pitt) and Data Center (GSPH).,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2022,0.0
NCT02572453,,2015-10-08,2022-05-09,,2022-08-15,2015-10-08,2015-10-09,ESTIMATED,2022-08-15,2022-09-13,ACTUAL,,,,2022-08-15,2022-09-13,ACTUAL,2016-04-04,ACTUAL,2016-04-04,2022-08,2022-08-31,2021-03-18,ACTUAL,2021-03-18,2021-03-18,ACTUAL,2021-03-18,,INTERVENTIONAL,,,"Phase 2 Study of AT13387 (Onalespib) in ALK+ ALCL, MCL, and BCL-6+ DLBCL","Phase 2 Trial of the Heat Shock Protein-90 (Hsp90) Inhibitor AT13387 (Onalespib) in Patients With Relapsed/Refractory ALK+ ALCL, Mantle Cell Lymphoma, and BCL6+ DLBCL",TERMINATED,,PHASE2,25.0,ACTUAL,National Cancer Institute (NCI),,3.0,,Drug supply issues,f,,,,t,,,,,,,,,,,,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,NIH,,,,,,,2021,0.0
NCT05027867,,2021-08-25,,,2023-08-14,2021-08-25,2021-08-30,ACTUAL,,,,,,,2023-08-14,2023-08-16,ACTUAL,2021-12-06,ACTUAL,2021-12-06,2023-08,2023-08-31,2022-08-26,ACTUAL,2022-08-26,2022-08-26,ACTUAL,2022-08-26,,INTERVENTIONAL,,,KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer,"An Open-Label, Multicenter, Phase 2 Study of the Safety and Efficacy of KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer (SCLC)",TERMINATED,,PHASE2,3.0,ACTUAL,"Kartos Therapeutics, Inc.",,2.0,,Unanticipated and extremely high screen failure rate. There was no evidence of safety concerns in the study.,f,,,,,t,f,,,,,,,,,,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,INDUSTRY,,,,,,,2022,0.0
NCT03845322,,2019-02-07,,,2022-05-18,2019-02-14,2019-02-19,ACTUAL,,,,,,,2022-05-18,2022-05-25,ACTUAL,2018-12-18,ACTUAL,2018-12-18,2019-02,2019-02-28,2020-02-26,ACTUAL,2020-02-26,2020-02-26,ACTUAL,2020-02-26,,INTERVENTIONAL,CACTIS,,Curcumin/Turmeric as a Treatment for Patients With Subdural Hematomas Recurrence,Clinical Action of Curcumin/Turmeric in Chronic Subdural Hematoma Recurrence,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of New Mexico,,2.0,,12 Screen failures and Changes in PI and loss of residency program.,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,OTHER,,,,,,,2020,0.0
NCT03558516,,2018-05-16,2020-06-07,,2020-06-28,2018-06-14,2018-06-15,ACTUAL,2020-06-28,2020-07-13,ACTUAL,,,,2020-06-28,2020-07-13,ACTUAL,2018-08-01,ACTUAL,2018-08-01,2020-06,2020-06-30,2020-02-18,ACTUAL,2020-02-18,2020-02-03,ACTUAL,2020-02-03,,INTERVENTIONAL,,,Magnesium and Intraoperative Blood Loss in Meningioma Surgery,The Effect of Magnesium Sulphate on Intraoperative Blood Loss in Meningioma Patient Undergoing Craniotomy With Tumor Removal,COMPLETED,,PHASE3,80.0,ACTUAL,Mahidol University,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,OTHER,,,,,,,2020,1.0
NCT03670953,,2018-09-12,2023-01-16,,2023-01-16,2018-09-12,2018-09-14,ACTUAL,2023-01-16,2023-02-09,ACTUAL,,,,2023-01-16,2023-02-09,ACTUAL,2018-11-06,ACTUAL,2018-11-06,2022-09,2022-09-30,2021-06-15,ACTUAL,2021-06-15,2021-06-15,ACTUAL,2021-06-15,,INTERVENTIONAL,,The Safety Analysis Set included all participants who were treated with any study drug.,A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations,A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations,COMPLETED,,PHASE3,630.0,ACTUAL,"Impax Laboratories, LLC",,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,INDUSTRY,,,,,,,2021,1.0
NCT03933449,,2019-04-29,2020-02-12,,2023-03-28,2019-04-29,2019-05-01,ACTUAL,2020-02-12,2020-02-26,ACTUAL,,,,2023-03-28,2023-03-29,ACTUAL,2016-12-29,ACTUAL,2016-12-29,2023-03,2023-03-31,2022-03-14,ACTUAL,2022-03-14,2019-02-13,ACTUAL,2019-02-13,,INTERVENTIONAL,,,Study of Pembrolizumab (MK-3475) Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)-China Extension Study,"A Phase III Randomized Open-Label Study of Single Agent Pembrolizumab vs Physicians' Choice of Single Agent Docetaxel, Paclitaxel, or Irinotecan in Subjects With Advanced/Metastatic Adenocarcinoma and Squamous Cell Carcinoma of the Esophagus That Have Progressed After First-Line Standard Therapy (KEYNOTE-181)",COMPLETED,,PHASE3,123.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,INDUSTRY,,,,,,,2022,1.0
NCT05366855,,2022-04-25,,,2024-08-12,2022-05-05,2022-05-09,ACTUAL,,,,,,,2024-08-12,2024-08-14,ACTUAL,2022-04-21,ACTUAL,2022-04-21,2024-08,2024-08-31,2024-07-17,ACTUAL,2024-07-17,2024-02-08,ACTUAL,2024-02-08,,INTERVENTIONAL,GEMINI-2,,Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis,"A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis",TERMINATED,,PHASE3,42.0,ACTUAL,"AnaptysBio, Inc.",,4.0,,"AnaptysBio has concluded the GEMINI-2 trial, with all trial participants having been treated with imsidolimab for approximately six months and the furthest patient having been treated through 92 weeks",f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,INDUSTRY,,,,,,,2024,0.0
NCT03964207,,2019-05-24,2022-11-15,,2023-10-11,2019-05-24,2019-05-28,ACTUAL,2023-10-11,2023-10-13,ACTUAL,,,,2023-10-11,2023-10-13,ACTUAL,2019-11-25,ACTUAL,2019-11-25,2023-10,2023-10-31,2021-11-16,ACTUAL,2021-11-16,2021-10-19,ACTUAL,2021-10-19,,INTERVENTIONAL,,Treated set (TS) is defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.,A Study on Whether Patients Prefer the Spiriva® Respimat® or the Spiriva® Handihaler® for Treating Their Chronic Obstructive Pulmonary Disease (COPD),"A Randomized, Open-label, Two-way Crossover Study to Compare Patient Acceptability/Preference of Tiotropium Respimat® With Tiotropium Handihaler® in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)",COMPLETED,,PHASE4,72.0,ACTUAL,Boehringer Ingelheim,,2.0,,,f,,,,f,f,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,INDUSTRY,,,,,,,2021,1.0
NCT03176771,,2017-06-02,2022-08-25,,2023-08-23,2017-06-02,2017-06-05,ACTUAL,2023-08-08,2023-08-14,ACTUAL,,,,2023-08-23,2023-09-06,ACTUAL,2017-06-21,ACTUAL,2017-06-21,2023-08,2023-08-31,2020-09-29,ACTUAL,2020-09-29,2020-09-29,ACTUAL,2020-09-29,,INTERVENTIONAL,,Safety analysis set,Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia,"A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Fixed-Dose Study to Evaluate the Efficacy and Safety of MT-5199 for the Treatment in Patients With Tardive Dyskinesia (J-KINECT)",COMPLETED,,PHASE2/PHASE3,256.0,ACTUAL,Mitsubishi Tanabe Pharma Corporation,,5.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,INDUSTRY,,,,,,,2020,1.0
NCT03642990,,2018-08-20,2022-04-28,,2023-03-17,2018-08-20,2018-08-22,ACTUAL,2023-03-17,2023-04-12,ACTUAL,,,,2023-03-17,2023-04-12,ACTUAL,2019-11-08,ACTUAL,2019-11-08,2023-03,2023-03-31,2022-02-24,ACTUAL,2022-02-24,2021-08-18,ACTUAL,2021-08-18,,INTERVENTIONAL,,,NR in Chemo-induced Peripheral Neuropathy,Nicotinamide Riboside (NR) in Paclitaxel-induced Peripheral Neuropathy,TERMINATED,,PHASE2,5.0,ACTUAL,University of Iowa,This trial was limited to a non-curative population of women receiving taxane chemotherapy without added platinum-based agents. Difficulty in recruiting this small population led to eventual termination of the trial. Dose escalation to 1000 mg/day did not occur for any subject due to physician concerns that subjects were not tolerating the 300 mg dose well.,1.0,,Enrollment challenges,f,,,,t,t,f,,,,,,IPD will be available for sharing immediately after publication and ending 5 years after article publication.,"IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.",,YES,"All of the individual participant data collected during the trial, after de-identification, will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. The IPD will be available to sharing immediately after publication and ending 5 years after article publication",2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,OTHER,,,,,,,2022,0.0
NCT03353220,,2017-11-21,2021-05-05,,2024-03-25,2017-11-21,2017-11-27,ACTUAL,2021-08-29,2021-09-23,ACTUAL,,,,2024-03-25,2024-03-27,ACTUAL,2018-01-03,ACTUAL,2018-01-03,2024-03,2024-03-31,2020-02-14,ACTUAL,2020-02-14,2020-02-14,ACTUAL,2020-02-14,,INTERVENTIONAL,,,Predictors of Lorcaserin-Induced Weight Loss,Central Mechanisms and Predictors of Lorcaserin-Induced Weight Loss,TERMINATED,,PHASE4,32.0,ACTUAL,Columbia University,Study was stopped prematurely during Phase 2 due to lack of drug supply.,2.0,,The FDA advised of a possible health risk associated with lorcaserin and the drug is being withdrawn.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,OTHER,,,,,,,2020,0.0
NCT03386721,,2017-12-22,2022-12-23,,2023-02-20,2017-12-22,2017-12-29,ACTUAL,2023-02-20,2023-02-21,ACTUAL,,,,2023-02-20,2023-02-21,ACTUAL,2018-02-19,ACTUAL,2018-02-19,2023-02,2023-02-28,2021-12-30,ACTUAL,2021-12-30,2021-12-30,ACTUAL,2021-12-30,,INTERVENTIONAL,,"Safety population included all participants who received at least one dose of study treatment, whether or not prematurely withdrawn from the study.",Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors,"An Open-Label, Multicenter, Phase II Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa (RO6874281), an Immunocytokine, Consisting of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), in Combination With Atezolizumab (Anti-PD-L1), Administered Intravenously, in Participants With Advanced and/or Metastatic Solid Tumors",TERMINATED,,PHASE2,256.0,ACTUAL,Hoffmann-La Roche,,17.0,,"The Sponsor discontinued the development of Simlukafusp alfa due to portfolio prioritization, not due to any safety, efficacy, or quality issues.",f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,INDUSTRY,,,,,,,2021,0.0
NCT04524858,,2020-08-19,2022-03-23,,2023-08-25,2020-08-21,2020-08-24,ACTUAL,2023-08-25,2023-09-21,ACTUAL,,,,2023-08-25,2023-09-21,ACTUAL,2020-10-23,ACTUAL,2020-10-23,2023-08,2023-08-31,2021-02-25,ACTUAL,2021-02-25,2021-02-25,ACTUAL,2021-02-25,,INTERVENTIONAL,,"Due to study termination and only 1 participant being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.",Study of ATI-450 in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS),"A Phase 2a, Open-Label, Single-Arm Study to Investigate the Safety and Efficacy of ATI-450 for the Maintenance of Remission in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS) Previously Managed With Anti-IL-1 Therapy",TERMINATED,,PHASE2,1.0,ACTUAL,"Aclaris Therapeutics, Inc.",,1.0,,"Due to patient enrollment challenges stemming from the COVID-19 pandemic, Aclaris has decided to focus its efforts and resources on other immuno-inflammatory diseases.",f,,,,f,t,f,,,,,,,,,,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,INDUSTRY,,,,,,,2021,0.0
NCT02592824,,2015-10-28,2022-05-21,,2023-02-23,2015-10-29,2015-10-30,ESTIMATED,2023-02-23,2023-12-04,ACTUAL,,,,2023-02-23,2023-12-04,ACTUAL,2015-11-15,ACTUAL,2015-11-15,2023-02,2023-02-28,2020-10-30,ACTUAL,2020-10-30,2020-10-30,ACTUAL,2020-10-30,,INTERVENTIONAL,GLUTAMICSII,,Glutamate for Metabolic Intervention in Coronary Surgery II,Phase III Study of Metabolic Intervention With Glutamate in Coronary Surgery II,COMPLETED,,PHASE3,321.0,ACTUAL,"University Hospital, Linkoeping",The main limitations of the study are: (i) it relies on a surrogate marker for heart failure (ii) the proportion of patients with diabetes had almost doubled compared to the cohort used for the sample size estimation,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,OTHER,,,,,,,2020,1.0
NCT04284254,,2019-11-11,,,2022-10-05,2020-02-24,2020-02-25,ACTUAL,,,,,,,2022-10-05,2022-10-07,ACTUAL,2022-12,ESTIMATED,2022-12-31,2022-10,2022-10-31,2023-06,ESTIMATED,2023-06-30,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,MT2018-18: Sleeping Beauty Transposon-Engineered Plasmablasts for Hurler Syndrome Post Allo HSCT,Sleeping Beauty Transposon-Engineered Plasmablasts for Expression and Delivery of Alpha-L-iduronidase in Patients With Hurler Syndrome That Have Previously Undergone Allogeneic Transplantation,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Masonic Cancer Center, University of Minnesota",,2.0,,"Study went on hold because more pre-clinical work needs to be done per FDA feedback. However, the study never went off hold and the study team has decided to close this study without opening to enrollment.",f,,,,,t,f,,,f,,,,,,,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,OTHER,,,,,,,2023,0.0
NCT04101331,,2019-09-20,2023-05-08,,2024-01-31,2019-09-23,2019-09-24,ACTUAL,2023-05-08,2023-06-05,ACTUAL,,,,2024-01-31,2024-02-02,ACTUAL,2019-11-13,ACTUAL,2019-11-13,2023-08,2023-08-31,2024-01-11,ACTUAL,2024-01-11,2022-05-11,ACTUAL,2022-05-11,,INTERVENTIONAL,REDIRECT,Full analysis set (FAS): consist of all subjects who received at least one dose of AFM13.,Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides,A Phase II Open-label Multicenter Study to Assess the Efficacy and Safety of AFM13 in Patients With Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT),COMPLETED,,PHASE2,108.0,ACTUAL,Affimed GmbH,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,INDUSTRY,,,,,,,2024,1.0
NCT05954052,,2023-05-18,,,2023-08-21,2023-07-12,2023-07-20,ACTUAL,,,,,,,2023-08-21,2023-08-23,ACTUAL,2019-07-01,ACTUAL,2019-07-01,2023-08,2023-08-31,2023-08-15,ACTUAL,2023-08-15,2023-08-15,ACTUAL,2023-08-15,,INTERVENTIONAL,,,A Study of Glutathione in Children With Autism Spectrum Disorder,An Open-Label Study of Glutathione in Children With Autism Spectrum Disorder,TERMINATED,,PHASE4,6.0,ACTUAL,University of Chicago,,1.0,,lack of funding and difficulty with phlebotomy in children with Autism,,,,,f,t,f,,,t,,,Following the completion of the trial and until 2 years from the publication of the trial outcome data.,,,YES,,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,OTHER,,,,,,,2023,0.0
NCT02470585,,2015-06-10,2020-08-04,2020-04-29,2023-10-25,2015-06-10,2015-06-12,ESTIMATED,2020-08-26,2020-09-14,ACTUAL,2020-04-29,2020-05-04,ACTUAL,2023-10-25,2023-10-30,ACTUAL,2015-06-29,ACTUAL,2015-06-29,2023-06,2023-06-30,2023-10-05,ACTUAL,2023-10-05,2019-05-03,ACTUAL,2019-05-03,,INTERVENTIONAL,VELIA,The intention-to-treat (ITT) population consisted of all randomized participants.,"Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer",TERMINATED,,PHASE3,1140.0,ACTUAL,AbbVie,,3.0,,Business decision not related to patient safety,f,,,,t,t,,,,f,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,INDUSTRY,,,,,,,2023,0.0
NCT03303105,,2017-10-02,2021-06-27,,2023-02-16,2017-10-02,2017-10-05,ACTUAL,2021-06-27,2021-07-16,ACTUAL,,,,2023-02-16,2023-02-17,ACTUAL,2017-12-07,ACTUAL,2017-12-07,2023-02,2023-02-28,2020-06-16,ACTUAL,2020-06-16,2020-06-16,ACTUAL,2020-06-16,,INTERVENTIONAL,,,Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine,"A Multicenter, Randomized, Open-label Trial Evaluating the Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine",COMPLETED,,PHASE3,50.0,ACTUAL,"Otsuka Pharmaceutical Co., Ltd.",,2.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,INDUSTRY,,,,,,,2020,1.0
NCT03573297,,2018-06-05,2023-08-28,,2023-09-27,2018-06-27,2018-06-29,ACTUAL,2023-09-27,2023-09-28,ACTUAL,,,,2023-09-27,2023-09-28,ACTUAL,2018-06-15,ACTUAL,2018-06-15,2023-09,2023-09-30,2022-09-05,ACTUAL,2022-09-05,2022-09-05,ACTUAL,2022-09-05,,INTERVENTIONAL,,Safety Population: all participants who received at least 1 dose of study medication.,"A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features","A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in a Dose-reduction Paradigm in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features",COMPLETED,,PHASE3,901.0,ACTUAL,AbbVie,,4.0,,,f,,,,f,t,f,,,t,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,INDUSTRY,,,,,,,2022,1.0
NCT03821038,,2019-01-24,,,2021-10-19,2019-01-28,2019-01-29,ACTUAL,,,,,,,2021-10-19,2021-10-27,ACTUAL,2019-06-01,ACTUAL,2019-06-01,2021-10,2021-10-31,2021-10-06,ACTUAL,2021-10-06,2021-10-06,ACTUAL,2021-10-06,,INTERVENTIONAL,IRIS-7-C&D,,Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts in Sepsis Patients,"International, Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts (ALC) in Patients With Sepsis",TERMINATED,,PHASE2,21.0,ACTUAL,Revimmune,,2.0,,PK issue detected after bolus IV route administration,f,,,,t,t,f,,,,,,,,,NO,Study results will be published Individual data can't be shared and are protected by the new GDPR rule,2024-10-17 01:42:10.41747,2024-10-17 01:42:10.41747,INDUSTRY,,,,,,,2021,0.0
NCT03637660,,2018-08-16,2023-08-31,,2023-12-07,2018-08-16,2018-08-20,ACTUAL,2023-12-07,2023-12-26,ACTUAL,,,,2023-12-07,2023-12-26,ACTUAL,2018-10-31,ACTUAL,2018-10-31,2019-09-19,2019-09-19,2023-03-20,ACTUAL,2023-03-20,2022-09-07,ACTUAL,2022-09-07,,INTERVENTIONAL,,,Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection,A Phase 4 Comparative Trial of Benzathine Penicillin G 2.4 Million Units Administered as a Single Dose Versus Three Successive Weekly Doses for Treatment of Early Syphilis in Subjects With or Without HIV Infection,COMPLETED,,PHASE4,249.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,,f,f,,,f,,,,,,,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,NIH,,,,,,,2023,1.0
NCT03218384,,2017-07-12,2023-06-13,2023-04-03,2023-06-13,2017-07-13,2017-07-14,ACTUAL,2023-06-13,2023-07-05,ACTUAL,,2023-04-20,ACTUAL,2023-06-13,2023-07-05,ACTUAL,2017-09-07,ACTUAL,2017-09-07,2023-06,2023-06-30,2022-04-04,ACTUAL,2022-04-04,2022-04-04,ACTUAL,2022-04-04,,INTERVENTIONAL,,,Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency,Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency,TERMINATED,,PHASE2,20.0,ACTUAL,NYU Langone Health,,2.0,,Unable to complete enrollment as planned.,f,,,,f,t,t,,,f,,,,,,,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2022,0.0
NCT02255227,,2014-09-26,,,2023-06-13,2014-10-01,2014-10-02,ESTIMATED,,,,,,,2023-06-13,2023-06-15,ACTUAL,2015-04-13,ACTUAL,2015-04-13,2023-06,2023-06-30,2022-07-06,ACTUAL,2022-07-06,2019-08-06,ACTUAL,2019-08-06,,INTERVENTIONAL,PneumoMICI,,Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for CIBD,Phase IIb Multicenter Randomized Comparative Study of Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for Chronic Inflammatory Bowel Disease,TERMINATED,,PHASE2,104.0,ACTUAL,Centre Hospitalier Universitaire de Saint Etienne,,2.0,,low inclusion rates,f,,,,f,f,f,,,,,,,,,,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2022,0.0
NCT05133635,,2021-01-11,,,2021-11-22,2021-11-22,2021-11-24,ACTUAL,,,,,,,2021-11-22,2021-11-24,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2021-11,2021-11-30,2021-04-01,ACTUAL,2021-04-01,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,,,High-Dose Corticosteroid or Tocilizumab for Clinical Worsening of COVID-19,Comparison of the Treatment Efficacy of High-Dose Corticosteroid and Tocilizumab During Clinical Worsening in Patients With COVID-19 Pneumonia,WITHDRAWN,,PHASE4,0.0,ACTUAL,Marmara University,,2.0,,A recent study suggested a new corticosteroid regime for intensive care unit patients.,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,OTHER,,,,,,,2021,0.0
NCT04454567,,2020-06-18,2022-04-07,,2022-09-23,2020-06-30,2020-07-01,ACTUAL,2022-09-23,2022-10-20,ACTUAL,,,,2022-09-23,2022-10-20,ACTUAL,2020-11-11,ACTUAL,2020-11-11,2022-09,2022-09-30,2021-04-08,ACTUAL,2021-04-08,2021-04-08,ACTUAL,2021-04-08,,INTERVENTIONAL,,,A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors,"A Phase 2a, Multi-Center, Single-Blind, Placebo-Controlled Study Evaluating Treatment Intensification With ABI-H0731 in Subjects With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors",TERMINATED,,PHASE2,2.0,ACTUAL,Assembly Biosciences,"Study ABI-H0731-205 was terminated early by the study Sponsor for strategic reasons to prioritize research and development efforts on finite and curative HBV therapies. At the time of early termination, only 2 participants were enrolled, both of which discontinued their assigned study treatment early due to the study being terminated early by the Sponsor. As a result, the primary outcome of number of participants with HBV DNA \<LLOQ at Week 48 could not be assessed.",2.0,,"Study stopped due to a change in the Sponsor's overall development strategy from treatment of chronic disease to finite, curative treatments, and is based partially on the advice and feedback from experts and regulators.",f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,INDUSTRY,,,,,,,2021,0.0
NCT03698227,,2018-10-01,,,2020-07-13,2018-10-04,2018-10-05,ACTUAL,,,,,,,2020-07-13,2020-07-15,ACTUAL,2018-11-12,ACTUAL,2018-11-12,2020-07,2020-07-31,2020-06-25,ACTUAL,2020-06-25,2020-06-25,ACTUAL,2020-06-25,,INTERVENTIONAL,,,OlaReDo - Olaratumab and Rechallenge With Doxorubicin in Soft Tissue Sarcoma Patients,"Efficacy of Olaratumab and Rechallenge With Doxorubicin in Anthracycline Pretreated, Advanced Soft Tissue Sarcoma Patients. An Exploratory Phase-II Study",TERMINATED,,PHASE2,2.0,ACTUAL,Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest,,1.0,,Lack of efficacy on olaratumab,f,,,,t,f,f,,,,,,,,,NO,No IPD will be shared,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2020,0.0
NCT04891133,,2021-05-07,,,2023-02-02,2021-05-12,2021-05-18,ACTUAL,,,,,,,2023-02-02,2023-02-06,ACTUAL,2021-06-03,ACTUAL,2021-06-03,2023-02,2023-02-28,2023-01-23,ACTUAL,2023-01-23,2022-12-15,ACTUAL,2022-12-15,,INTERVENTIONAL,Bari-SolidAct,,EU SolidAct: An Adaptive Pandemic and Emerging Infection Platform Trial,European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial,TERMINATED,,PHASE2/PHASE3,290.0,ACTUAL,Oslo University Hospital,,2.0,,"The trial was stopped prematurely due to external evidence that arose during the study period showing that the IMP, baricitinib, was not effective in the primary study population.",f,,,,t,t,f,,,t,,,,,,YES,"Individual patient-level data will be made as public as possible while maintaining the integrity and privacy of the trial participants. Anonymized data will be made publicly available using a data repository, including any programming code used to produce the trial results. De-identified data will be made available upon request and evaluation of the requestee's ability and willingness to maintain the integrity and privacy of the trial participants. Further details of data sharing will be given in a separate data sharing plan.",2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,OTHER,,,,,,,2023,0.0
NCT02942056,,2016-10-20,,,2019-08-02,2016-10-20,2016-10-21,ESTIMATED,,,,,,,2019-08-02,2019-08-06,ACTUAL,2017-01,,2017-01-31,2019-08,2019-08-31,2020-01,ESTIMATED,2020-01-31,2020-01,ESTIMATED,2020-01-31,,INTERVENTIONAL,,,The Effect of Cinnamon Cassia on Diabetes Control and Cardiometabolic Risk Factors in Adults With Type 2 Diabetes Mellitus,The Effect of Cinnamon Cassia on Diabetes Control and Cardiometabolic Risk Factors in Adults With Type 2 Diabetes Mellitus,WITHDRAWN,,PHASE2,0.0,ACTUAL,Oregon Health and Science University,,2.0,,Could not obtain appropriate funding or standardized manufacturing for cinnamon tablets,f,,,,t,,,,,,,,,,,,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,OTHER,,,,,,,2020,0.0
NCT03354273,,2017-11-21,2023-05-04,,2023-06-19,2017-11-21,2017-11-27,ACTUAL,2023-06-19,2023-07-12,ACTUAL,,,,2023-06-19,2023-07-12,ACTUAL,2018-06-05,ACTUAL,2018-06-05,2023-06,2023-06-30,2022-05-05,ACTUAL,2022-05-05,2022-05-05,ACTUAL,2022-05-05,,INTERVENTIONAL,,The enrolled population consisted of all participants who signed informed consent.,An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD),"A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease",COMPLETED,,PHASE3,730.0,ACTUAL,GE Healthcare,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,INDUSTRY,,,,,,,2022,1.0
NCT03686683,,2018-09-25,2024-08-07,,2024-09-30,2018-09-25,2018-09-27,ACTUAL,2024-09-30,2024-10-08,ACTUAL,,,,2024-09-30,2024-10-08,ACTUAL,2018-10-18,ACTUAL,2018-10-18,2023-10,2023-10-31,2023-03-10,ACTUAL,2023-03-10,2023-03-10,ACTUAL,2023-03-10,,INTERVENTIONAL,ProVent,,Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer,"A Randomized Phase 3, Open-Label Trial of Sipuleucel-T Administered To Patients On Active Surveillance For Newly Diagnosed Prostate Cancer",COMPLETED,,PHASE3,532.0,ACTUAL,Dendreon,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,INDUSTRY,,,,,,,2023,1.0
NCT01665144,,2012-08-03,2018-08-06,,2024-05-07,2012-08-14,2012-08-15,ESTIMATED,2018-10-04,2018-10-31,ACTUAL,,,,2024-05-07,2024-06-05,ACTUAL,2012-12-20,ACTUAL,2012-12-20,2024-05,2024-05-31,2023-03-31,ACTUAL,2023-03-31,2016-04-29,ACTUAL,2016-04-29,,INTERVENTIONAL,,,Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND),"A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.",COMPLETED,,PHASE3,1651.0,ACTUAL,Novartis,,2.0,,,f,,,,,,,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com~Locations: central Contact Info Novartis.email@novartis.com",2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,INDUSTRY,,,,,,,2023,1.0
NCT03515824,,2018-04-23,2021-01-26,,2021-02-19,2018-04-23,2018-05-04,ACTUAL,2021-01-26,2021-02-12,ACTUAL,,,,2021-02-19,2021-03-09,ACTUAL,2018-08-13,ACTUAL,2018-08-13,2021-02,2021-02-28,2020-02-18,ACTUAL,2020-02-18,2020-02-18,ACTUAL,2020-02-18,,INTERVENTIONAL,,No participants were enrolled in Part B since study was terminated at the completion of Part A.,Study of MK-1697 in Participants With Advanced Solid Tumors (MK-1697-001),A Phase 1 Study of MK-1697 in Participants With Advanced Solid Tumors,TERMINATED,,PHASE1,22.0,ACTUAL,Merck Sharp & Dohme LLC,The study was terminated due to business reasons.,4.0,,Business Reasons,f,,,,f,f,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,INDUSTRY,,,,,,,2020,0.0
NCT05275023,,2022-03-02,,,2024-07-17,2022-03-02,2022-03-11,ACTUAL,,,,,,,2024-07-17,2024-07-18,ACTUAL,2022-06-30,ACTUAL,2022-06-30,2024-07,2024-07-31,2024-05-31,ACTUAL,2024-05-31,2023-12-12,ACTUAL,2023-12-12,,INTERVENTIONAL,OCTOPUS-1,,"An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants","A Phase 2 Open-label Trial to Evaluate Safety, Efficacy, Tolerability, and Pharmacodynamics of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs, and a PD-1 Inhibitor in Chronic Hepatitis B Patients",COMPLETED,,PHASE2,37.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,,f,,,,f,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 02:30:25.386587,2024-10-15 02:30:25.386587,INDUSTRY,,,,,,,2024,0.0
NCT03679845,,2018-09-17,,,2021-08-31,2018-09-18,2018-09-20,ACTUAL,,,,,,,2021-08-31,2021-09-08,ACTUAL,2019-09-01,ACTUAL,2019-09-01,2021-08,2021-08-31,2021-06-30,ACTUAL,2021-06-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,,,Study to Assess Sarilumab in Halting Progression of Morphea,A Pilot Study to Assess the Safety and Efficacy of Sarilumab in Halting Progression of Morphea,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Massachusetts General Hospital,,1.0,,Difficulty in recruiting patients,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,OTHER,,,,,,,2021,0.0
NCT05275907,,2021-11-17,,,2023-10-11,2022-03-02,2022-03-11,ACTUAL,,,,,,,2023-10-11,2023-10-13,ACTUAL,2022-07-12,ACTUAL,2022-07-12,2023-10,2023-10-31,2023-10-04,ACTUAL,2023-10-04,2023-10-02,ACTUAL,2023-10-02,,INTERVENTIONAL,,,Mechanism of Hypertension Treatments in Liver Transplant Recipients (BLOCK LTR-HTN),Pilot Study to Assess Blockade of Calcium Channels and Sodium Chloride Cotransporters for Physiologic Abnormalities in Liver Transplant Associated Hypertension,WITHDRAWN,,PHASE4,0.0,ACTUAL,Northwestern University,,2.0,,Screened participants did not meet inclusion criteria prior to study completion date,f,,,,t,t,f,,,t,,,Following publication with no end date.,Any purpose.,,YES,"Individual participant data that underlie the results reported, after deidentification",2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,OTHER,,,,,,,2023,0.0
NCT04505098,,2020-08-05,,,2023-07-14,2020-08-07,2020-08-10,ACTUAL,,,,,,,2023-07-14,2023-07-18,ACTUAL,2020-08-07,ACTUAL,2020-08-07,2023-07,2023-07-31,2022-12-15,ACTUAL,2022-12-15,2022-12-15,ACTUAL,2022-12-15,,INTERVENTIONAL,MITIGATE,,A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults,A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE),TERMINATED,,PHASE4,39600.0,ACTUAL,Kaiser Permanente,,2.0,,The study was suspended by the IRB of record and subsequently terminated,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,OTHER,,,,,,,2022,0.0
NCT05022797,,2021-08-20,,,2024-05-10,2021-08-25,2021-08-26,ACTUAL,,,,,,,2024-05-10,2024-05-13,ACTUAL,2021-07-19,ACTUAL,2021-07-19,2024-05,2024-05-31,2022-11-22,ACTUAL,2022-11-22,2022-11-22,ACTUAL,2022-11-22,,INTERVENTIONAL,,,Reduction of MTX Levels After Glucarpidase Treatment in DLBCL Patients at Risk of CNS,"Reduction of MTX Levels After Treatment With Reduced Glucarpidase Dose in Patients With DLBCL at Risk of CNS Involvement Who Receive Cycles of HDMTX: an Open-label, Interventional, Non-randomized, Phase 2, Pilot, Multicenter Study",TERMINATED,,PHASE2,3.0,ACTUAL,Fundacion CRIS de Investigación para Vencer el Cáncer,,1.0,,closed because of low recruitment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,OTHER,,,,,,,2022,0.0
NCT04957914,,2021-07-08,,,2022-11-15,2021-07-08,2021-07-12,ACTUAL,,,,,,,2022-11-15,2022-11-16,ACTUAL,2021-07-14,ACTUAL,2021-07-14,2022-11-01,2022-11-01,2022-10-17,ACTUAL,2022-10-17,2022-10-17,ACTUAL,2022-10-17,,INTERVENTIONAL,,,A Study of LY3209590 on Low Blood Sugar in Participants With Type 2 Diabetes Mellitus,Effects of LY3209590 on Frequency and Severity of Hypoglycaemia Under Conditions of Increased Hypoglycaemic Risk Compared to Insulin Glargine in Participants With Type 2 Diabetes Mellitus,COMPLETED,,PHASE1,54.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,INDUSTRY,,,,,,,2022,1.0
NCT01910402,,2013-07-25,2016-07-25,,2024-02-14,2013-07-26,2013-07-29,ESTIMATED,2016-09-13,2016-10-31,ESTIMATED,,,,2024-02-14,2024-02-20,ACTUAL,2013-08-22,ACTUAL,2013-08-22,2024-02,2024-02-29,2022-08-18,ACTUAL,2022-08-18,2015-09-22,ACTUAL,2015-09-22,,INTERVENTIONAL,,Baseline Characteristic data are reported for members of the ITT-E Population which comprised of all randomized participants who received at least one dose of study treatment.,A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA),"A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine Once Daily Compared to Atazanavir and Ritonavir Plus Tenofovir/Emtricitabine Once Daily in HIV-1 Infected Antiretroviral Therapy Naïve Women",COMPLETED,,PHASE3,499.0,ACTUAL,ViiV Healthcare,,2.0,,,f,,,,f,t,f,,,,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/,YES,Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,INDUSTRY,,,,,,,2022,1.0
NCT05188664,,2021-12-08,,,2023-12-10,2021-12-27,2022-01-12,ACTUAL,,,,,,,2023-12-10,2023-12-18,ACTUAL,2022-05-10,ACTUAL,2022-05-10,2023-10,2023-10-31,2023-11-14,ACTUAL,2023-11-14,2023-11-14,ACTUAL,2023-11-14,,INTERVENTIONAL,,,Study of LaNova Medicines(LM)-302 in Combination With Toripalimab in Patients With Advanced Solid Tumors,"A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM- 302 in Combination With Toripalimab in Patients With Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,20.0,ACTUAL,LaNova Medicines Limited,,3.0,,Sponsor's decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,INDUSTRY,,,,,,,2023,0.0
NCT03571204,,2018-06-22,2022-01-14,,2022-01-18,2018-06-26,2018-06-27,ACTUAL,2022-01-18,2022-02-09,ACTUAL,,,,2022-01-18,2022-02-09,ACTUAL,2018-09-10,ACTUAL,2018-09-10,2021-03,2021-03-31,2021-03-29,ACTUAL,2021-03-29,2021-03-29,ACTUAL,2021-03-29,,INTERVENTIONAL,,Group 2 ART naiive,Combination Therapy With 3BNC117 and 10-1074 in HIV-Infected Individuals,An Exploratory Study of Combination Therapy With 3BNC117 and 10-1074 in HIV-Infected Individuals,TERMINATED,,PHASE1,27.0,ACTUAL,National Institutes of Health Clinical Center (CC),The study was terminated early due the the COVID-19 pandemic. The pre-defined samples size of 30 participants (15 per arm) for Group 1 was not not reached prior to closing the protocol.,3.0,,Coronavirus 2019 (COVID-19) pandemic,f,,,,,t,f,,,,,,,,,,,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,NIH,,,,,,,2021,0.0
NCT06115460,,2023-10-30,,,2023-11-02,2023-10-30,2023-11-03,ACTUAL,,,,,,,2023-11-02,2023-11-07,ACTUAL,2022-03-01,ACTUAL,2022-03-01,2023-11,2023-11-30,2023-06-15,ACTUAL,2023-06-15,2023-06-01,ACTUAL,2023-06-01,,INTERVENTIONAL,,,The Impact of Sitagliptin as an Add on Therapy With Closed Loop Control in Adolescents With Diabetic Nephropathy,The Impact of Sitagliptin as an Add on Therapy With Closed Loop Control in Adolescents With Type 1 Diabetes Mellitus and Diabetic Nephropathy,COMPLETED,,PHASE3,46.0,ACTUAL,Ain Shams University,,2.0,,,f,,,,t,f,f,,,f,,,,,,UNDECIDED,All data are available upon request,2024-10-17 01:47:52.012187,2024-10-17 01:47:52.012187,OTHER,,,,,,,2023,1.0
NCT01965704,,2013-10-15,2022-03-09,,2022-06-06,2013-10-15,2013-10-18,ESTIMATED,2022-04-13,2022-05-10,ACTUAL,,,,2022-06-06,2022-06-07,ACTUAL,2014-09-09,ACTUAL,2014-09-09,2022-06,2022-06-30,2020-09-16,ACTUAL,2020-09-16,2020-09-03,ACTUAL,2020-09-03,,INTERVENTIONAL,AIM2NAS,Participants who completed the protocol and met all inclusion criteria are included in the analysis.,Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women,AIM 2- Prevention of Neonatal Abstinence Syndrome,COMPLETED,,PHASE2,196.0,ACTUAL,Stanford University,,2.0,,,f,,,,t,t,,,,,,,,,,NO,We will not share any individual participant data with other researchers.,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,OTHER,,,,,,,2020,1.0
NCT03623568,,2018-08-02,,,2019-05-30,2018-08-06,2018-08-09,ACTUAL,,,,,,,2019-05-30,2019-06-03,ACTUAL,2019-02-15,ESTIMATED,2019-02-15,2019-05,2019-05-31,2021-04-15,ESTIMATED,2021-04-15,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant,Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant,WITHDRAWN,,PHASE4,0.0,ACTUAL,Massachusetts General Hospital,,1.0,,"did not move forward with IRB approval, competing study",f,,,,f,t,f,,,f,,,Anticipate data would be available to share within 6 months after the final patient completes the study.,Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.,,YES,Anticipate to share coded data with collaborators,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,OTHER,,,,,,,2021,0.0
NCT04830735,,2021-04-01,,,2022-08-05,2021-04-01,2021-04-05,ACTUAL,,,,,,,2022-08-05,2022-08-10,ACTUAL,2022-08-05,ACTUAL,2022-08-05,2022-08,2022-08-31,2024-12-15,ESTIMATED,2024-12-15,2023-12-15,ESTIMATED,2023-12-15,,INTERVENTIONAL,,,Dasatinib for the Treatment of Moderate and Severe COVID-19,A Phase II Randomized Double-Blind Trial of Dasatinib Modulation of Hyperinflammation in Moderate and Severe Patients With COVID-19,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Southern California,,2.0,,PI decided not to pursue study,f,,,,t,t,f,,,f,,,,,,,,2024-10-17 01:47:52.012187,2024-10-17 01:47:52.012187,OTHER,,,,,,,2024,0.0
NCT04858425,,2021-04-21,2024-03-21,,2024-09-16,2021-04-21,2021-04-26,ACTUAL,2024-07-01,2024-07-24,ACTUAL,,,,2024-09-16,2024-10-08,ACTUAL,2021-04-30,ACTUAL,2021-04-30,2023-06,2023-06-30,2023-09-10,ACTUAL,2023-09-10,2022-06-04,ACTUAL,2022-06-04,,INTERVENTIONAL,RESERVOIR,,Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection,"A 2-Part, 2-Arm, Phase 2, Randomized, Double-Blind, Placebo-Controlled Study on the Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection",TERMINATED,,PHASE2,166.0,ACTUAL,Entero Therapeutics,,2.0,,The termination of the study was a decision based on topline data analysis (no efficacy as per Day 43) of the study data.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,INDUSTRY,,,,,,,2023,0.0
NCT04083651,,2019-09-06,,,2021-05-05,2019-09-06,2019-09-10,ACTUAL,,,,,,,2021-05-05,2021-05-07,ACTUAL,2020-01-06,ESTIMATED,2020-01-06,2021-05,2021-05-31,2023-10-15,ESTIMATED,2023-10-15,2023-10-15,ESTIMATED,2023-10-15,,INTERVENTIONAL,,,A Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer,A Phase II/III Adaptive Study to Evaluate the Safety and Efficacy of Oral Methylnaltrexone Bromide Tablets in Subjects With Advanced Pancreatic Cancer,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,"Bausch Health Americas, Inc.",,2.0,,Due to pandemic challenges and consideration of a different study design in the future.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,INDUSTRY,,,,,,,2023,0.0
NCT02775435,,2016-05-15,2019-02-19,,2024-10-07,2016-05-15,2016-05-17,ESTIMATED,2019-03-18,2019-04-10,ACTUAL,,,,2024-10-07,2024-10-08,ACTUAL,2016-06-09,ACTUAL,2016-06-09,2024-10,2024-10-31,2023-09-14,ACTUAL,2023-09-14,2018-04-03,ACTUAL,2018-04-03,,INTERVENTIONAL,,,A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407),"A Randomized, Double-Blind, Phase III Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-407)",COMPLETED,,PHASE3,559.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,INDUSTRY,,,,,,,2023,1.0
NCT02920190,,2016-08-22,,,2020-09-17,2016-09-28,2016-09-30,ESTIMATED,,,,,,,2020-09-17,2020-09-21,ACTUAL,2020-09-01,ESTIMATED,2020-09-01,2020-09,2020-09-30,2021-12-31,ESTIMATED,2021-12-31,2021-09-01,ESTIMATED,2021-09-01,,INTERVENTIONAL,,,Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat,Reduction of Antigen-Lipid-Driven Monoclonal Gammopathies by Targeting Epicardial Fat and Its Lipids Content With Liraglutide: A Glucagon Like Peptide-1 Receptor Analogue (GLP-1RA),WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Miami,,1.0,,Lack of funds to cover the costs of the study medications,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 01:47:52.012187,2024-10-17 01:47:52.012187,OTHER,,,,,,,2021,0.0
NCT05011019,,2021-08-10,,,2024-03-19,2021-08-16,2021-08-18,ACTUAL,,,,,,,2024-03-19,2024-03-21,ACTUAL,2021-09-07,ACTUAL,2021-09-07,2024-03,2024-03-31,2024-02-02,ACTUAL,2024-02-02,2024-02-02,ACTUAL,2024-02-02,,INTERVENTIONAL,,,A Clinical Trial to Evaluate the Safety and Efficacy of AL2846 Capsules in Chinese Patients With Type I Neurofibromatosis,Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of AL2846 Capsules in Chinese Patients With Type I Neurofibromatosis (Neurofibromatosis and Malignant Peripheral Nerve Sheath Tumors),TERMINATED,,PHASE1/PHASE2,22.0,ACTUAL,"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",,1.0,,sponsor adjusts its research and development strategy,f,,,,,f,f,,,,,,,,,,,2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,INDUSTRY,,,,,,,2024,0.0
NCT02913261,,2016-09-18,2021-10-23,,2022-05-09,2016-09-21,2016-09-23,ESTIMATED,2022-05-09,2023-02-08,ACTUAL,,,,2022-05-09,2023-02-08,ACTUAL,2017-03-10,ACTUAL,2017-03-10,2022-05,2022-05-31,2021-04-23,ACTUAL,2021-04-23,2019-06-24,ACTUAL,2019-06-24,,INTERVENTIONAL,REACH2,Full Analysis Set (FAS): The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.,Safety and Efficacy of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation,A Phase III Randomized Open-label Multi-center Study of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation,COMPLETED,,PHASE3,310.0,ACTUAL,Novartis,,2.0,,,f,,,,t,f,f,,,,,,,,https://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,INDUSTRY,,,,,,,2021,1.0
NCT03923257,,2019-03-29,,,2021-06-03,2019-04-17,2019-04-22,ACTUAL,,,,,,,2021-06-03,2021-06-08,ACTUAL,2020-08-04,ACTUAL,2020-08-04,2021-06,2021-06-30,2021-06-03,ACTUAL,2021-06-03,2021-06-03,ACTUAL,2021-06-03,,INTERVENTIONAL,,,Dosimetry Guided PRRT With 177Lu-DOTATATE in Children and Adolescents,Phase I Trial of Peptide Receptor Radiotherapy (PRRT) With 177Lu-DOTA-tyr3-Octreotate (177Lu-DOTATATE) in Children and Adolescents With Neuroendocrine Tumor or Pheochromocytoma/Paraganglioma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Iowa,,1.0,,competing clinical trial opening,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,OTHER,,,,,,,2021,0.0
NCT05077930,,2021-10-08,,,2023-11-28,2021-10-12,2021-10-14,ACTUAL,,,,,,,2023-11-28,2023-11-29,ACTUAL,2022-01-06,ACTUAL,2022-01-06,2023-11,2023-11-30,2022-04-07,ACTUAL,2022-04-07,2022-04-04,ACTUAL,2022-04-04,,INTERVENTIONAL,,,Convalescent Plasma Therapy for Hospitalized Patients With COVID-19,Validation Protocol for The Clinical Use of Convalescent Plasma for Hospitalized Patients With COVID-19. A Prospective Study at a Hospital in Southern Brazil.,COMPLETED,,PHASE2,38.0,ACTUAL,Science Valley Research Institute,,2.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,OTHER,,,,,,,2022,0.0
NCT05051579,,2021-09-17,2023-08-23,,2023-08-23,2021-09-17,2021-09-21,ACTUAL,2023-08-23,2023-09-13,ACTUAL,,,,2023-08-23,2023-09-13,ACTUAL,2021-09-29,ACTUAL,2021-09-29,2023-08,2023-08-31,2022-11-22,ACTUAL,2022-11-22,2022-08-25,ACTUAL,2022-08-25,,INTERVENTIONAL,,All randomized participants.,A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities,A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities,COMPLETED,,PHASE2,272.0,ACTUAL,Eli Lilly and Company,,7.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,INDUSTRY,,,,,,,2022,1.0
NCT04774809,,2021-02-24,,,2022-07-11,2021-02-24,2021-03-01,ACTUAL,,,,,,,2022-07-11,2022-07-13,ACTUAL,2020-01-29,ACTUAL,2020-01-29,2022-06,2022-06-30,2022-03-21,ACTUAL,2022-03-21,2022-03-21,ACTUAL,2022-03-21,,INTERVENTIONAL,,,Assess the Efficacy and Safety of SHR0302 Ointment in Adult Patients With Vitiligo,"A Randomized, Double-blind, Vehicle-Controlled, Phase II/Ⅲ Seamless Adaptive Clinical Trail to Evaluate the Efficacy and Safety of SHR0302 Ointment in Adult Patients With Vitiligo",TERMINATED,,PHASE2/PHASE3,75.0,ACTUAL,Reistone Biopharma Company Limited,,3.0,,terminated by sponsor,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 12:48:10.452551,2024-10-16 12:48:10.452551,INDUSTRY,,,,,,,2022,0.0
NCT04711863,,2021-01-13,,,2021-04-14,2021-01-13,2021-01-15,ACTUAL,,,,,,,2021-04-14,2021-04-19,ACTUAL,2021-01-16,ACTUAL,2021-01-16,2021-04,2021-04-30,2021-07-31,ESTIMATED,2021-07-31,2021-05-31,ESTIMATED,2021-05-31,,INTERVENTIONAL,,,Fluvoxamine for Adults With Mild to Moderate COVID-19,"Fluvoxamine for Adults With Mild to Moderate COVID-19: A Single-blind, Randomized, Placebo-controlled Trial",SUSPENDED,,PHASE2,400.0,ESTIMATED,Asan Medical Center,,2.0,,Closure of main community treatment center,f,,,,,f,f,,,f,,,,,,NO,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,OTHER,,,,,,,2021,0.0
NCT04168957,,2018-04-13,,,2022-02-15,2019-11-16,2019-11-19,ACTUAL,,,,,,,2022-02-15,2022-03-03,ACTUAL,2017-10-25,ACTUAL,2017-10-25,2022-02,2022-02-28,2020-11-12,ACTUAL,2020-11-12,2019-08-27,ACTUAL,2019-08-27,,INTERVENTIONAL,,,An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007,An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007,TERMINATED,,PHASE1,11.0,ACTUAL,"Athenex, Inc.",,1.0,,No need to complete the overall survival (OS) follow-up as the sample size was too small to interpret OS.,f,,,,f,t,f,,,t,,,,,,UNDECIDED,,2024-10-17 01:47:52.012187,2024-10-17 01:47:52.012187,INDUSTRY,,,,,,,2020,0.0
NCT01700569,,2012-09-12,,,2023-02-20,2012-10-02,2012-10-04,ESTIMATED,,,,,,,2023-02-20,2023-02-21,ACTUAL,2013-01,ACTUAL,2013-01-31,2021-05,2021-05-31,2021-04-16,ACTUAL,2021-04-16,2019-12-12,ACTUAL,2019-12-12,,INTERVENTIONAL,FOLAGLI,,Phase-1 Study of Folinic Acid to Modulate MGMT Gene in Glioblastoma,"Phase I Study of Escalated Pharmacologic Dose, of Oral Folinic Acid in Combination With Temozolomide, According to Stupp R. Regimen, in Patients With Operated Grade-IV Astocytoma and a Non-methylated Gene Status of MGMT.",TERMINATED,,PHASE1,24.0,ACTUAL,Institut Cancerologie de l'Ouest,,1.0,,changing the standard of care,f,,,,t,,,,,,,,,,,,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,OTHER,,,,,,,2021,0.0
NCT02919436,,2016-09-28,2021-10-15,,2022-01-27,2016-09-28,2016-09-29,ESTIMATED,2022-01-27,2022-02-17,ACTUAL,,,,2022-01-27,2022-02-17,ACTUAL,2016-03,,2016-03-31,2022-01,2022-01-31,2020-11,ACTUAL,2020-11-30,2020-01,ACTUAL,2020-01-31,,INTERVENTIONAL,DRIPS,,Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery,Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery,COMPLETED,,PHASE4,610.0,ACTUAL,MaineHealth,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,OTHER,,,,,,,2020,1.0
NCT03880474,,2019-02-21,2021-01-29,,2021-04-23,2019-03-14,2019-03-19,ACTUAL,2021-04-23,2021-04-26,ACTUAL,,,,2021-04-23,2021-04-26,ACTUAL,2019-03-18,ACTUAL,2019-03-18,2021-04,2021-04-30,2020-01-21,ACTUAL,2020-01-21,2019-10-15,ACTUAL,2019-10-15,,INTERVENTIONAL,,,Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults,A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults Aged 18 Years and Over,TERMINATED,,PHASE2,2364.0,ACTUAL,Barinthus Biotherapeutics,,2.0,,The trial is being stopped for futility. Season 2 cancelled.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 01:47:52.012187,2024-10-17 01:47:52.012187,INDUSTRY,,,,,,,2020,0.0
NCT04596293,,2020-10-15,2023-06-16,,2023-08-16,2020-10-20,2020-10-22,ACTUAL,2023-08-16,2023-09-07,ACTUAL,,,,2023-08-16,2023-09-07,ACTUAL,2021-06-11,ACTUAL,2021-06-11,2023-08,2023-08-31,2022-07-12,ACTUAL,2022-07-12,2022-05-17,ACTUAL,2022-05-17,,INTERVENTIONAL,,,Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis,"A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects With Moderate to Severe Ulcerative Colitis, Incorporating a Response-adaptive, Double-blind Extension Phase",COMPLETED,,PHASE2,38.0,ACTUAL,"Bridge Biotherapeutics, Inc.",,3.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-17 01:47:52.012187,2024-10-17 01:47:52.012187,INDUSTRY,,,,,,,2022,1.0
NCT04816214,,2021-03-22,2023-10-04,,2024-03-01,2021-03-24,2021-03-25,ACTUAL,2023-10-04,2023-10-30,ACTUAL,,,,2024-03-01,2024-03-05,ACTUAL,2021-09-22,ACTUAL,2021-09-22,2024-03,2024-03-31,2022-12-27,ACTUAL,2022-12-27,2022-12-27,ACTUAL,2022-12-27,,INTERVENTIONAL,GEOMETRY-E,,Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy,"A Phase III Randomized, Controlled, Open-label, Multicenter, Global Study of Capmatinib in Combination With Osimertinib Versus Platinum - Pemetrexed Based Doublet Chemotherapy in Patients With Locally Advanced or Metastatic NSCLC Harboring EGFR Activating Mutations Who Have Progressed on Prior Generation EGFR-TKI Therapy and Whose Tumors Are T790M Mutation Negative and Harbor MET Amplification (GEOMETRY-E)",TERMINATED,,PHASE3,6.0,ACTUAL,Novartis,,3.0,,Novartis decided to terminate the study based on a business consideration and not related with any safety concerns. Randomized part was not initiated,,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,INDUSTRY,,,,,,,2022,0.0
NCT03347123,,2017-11-14,2022-02-02,,2022-02-24,2017-11-16,2017-11-20,ACTUAL,2022-02-24,2022-02-28,ACTUAL,,,,2022-02-24,2022-02-28,ACTUAL,2018-03-21,ACTUAL,2018-03-21,2022-02,2022-02-28,2021-01-29,ACTUAL,2021-01-29,2021-01-29,ACTUAL,2021-01-29,,INTERVENTIONAL,,Full analysis set included all participants enrolled in the study who received at least 1 dose of combination therapy.,A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Malignancies (ECHO-208),"A Phase 1/2, Open-Label, Dose-Escalation, Safety, Tolerability, and Efficacy Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies (ECHO-208)",TERMINATED,,PHASE1/PHASE2,11.0,ACTUAL,Incyte Corporation,,7.0,,A business decision made by Incyte after analysis of data from a sister study.,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,INDUSTRY,,,,,,,2021,0.0
NCT04937738,,2021-06-04,,,2024-09-30,2021-06-23,2021-06-24,ACTUAL,,,,,,,2024-09-30,2024-10-08,ACTUAL,2021-07-21,ACTUAL,2021-07-21,2024-09,2024-09-30,2023-02-01,ACTUAL,2023-02-01,2023-02-01,ACTUAL,2023-02-01,,INTERVENTIONAL,PECORINO,,Perioperative Chemotherapy in Gastric Cancer,Treatment Discontinuation Associated With Perioperative Toxicity of FLOT Versus XELOX Chemotherapy in Patient With Resectable Gastric Cancer; Phase 2,TERMINATED,,PHASE2,69.0,ACTUAL,Ukrainian Society of Clinical Oncology,,2.0,,High rate of disease progression in XELOX arm,f,,,,t,f,f,,,f,,,Data will be available after initial paper is published.,By request,,YES,After the initial publication every participant will recieve all the data to provide further data exploration.,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,OTHER,,,,,,,2023,0.0
NCT05718297,,2023-01-30,,,2024-10-07,2023-01-30,2023-02-08,ACTUAL,,,,,,,2024-10-07,2024-10-08,ACTUAL,2024-06-07,ACTUAL,2024-06-07,2024-10,2024-10-31,2024-09-30,ACTUAL,2024-09-30,2024-09-30,ACTUAL,2024-09-30,,INTERVENTIONAL,BOUNCE,,Brigatinib Post Definitive Chemo-radiotherapy in Patients with ALK-fusion Non-small Cell Lung Cancer,"A Multicentre, Randomised, Phase II Trial of Brigatinib Consolidation Versus Observation or Durvalumab in Patients with Unresectable Stage III NSCLC and ALK-rearrangement, After Definitive Chemo-radiotherapy",WITHDRAWN,,PHASE2,0.0,ACTUAL,ETOP IBCSG Partners Foundation,,2.0,,"Despite our efforts, the trial faced challenges like a longer activation period and slower accrual. We proposed a redesign, but TAKEDA withdrew. As a non-profit organisation, we can't continue without TAKEDA's support and must discontinue the trial.",f,,,,t,f,f,,,f,,,,,,YES,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,NETWORK,,,,,,,2024,0.0
NCT03639714,,2018-08-06,,,2023-09-11,2018-08-18,2018-08-21,ACTUAL,,,,,,,2023-09-11,2023-09-13,ACTUAL,2019-02-13,ACTUAL,2019-02-13,2023-09,2023-09-30,2022-11-10,ACTUAL,2022-11-10,2022-11-10,ACTUAL,2022-11-10,,INTERVENTIONAL,,,A Study of a Personalized Neoantigen Cancer Vaccine,"An International Phase 1/2 Study of GRT-C901/GRT-R902, a Neoantigen Cancer Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors",COMPLETED,,PHASE1/PHASE2,29.0,ACTUAL,"Gritstone bio, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,INDUSTRY,,,,,,,2022,1.0
NCT03551626,,2018-04-30,2022-09-15,,2024-06-10,2018-05-28,2018-06-11,ACTUAL,2023-09-07,2024-03-18,ACTUAL,,,,2024-06-10,2024-06-12,ACTUAL,2018-08-29,ACTUAL,2018-08-29,2024-06,2024-06-30,2021-09-16,ACTUAL,2021-09-16,2020-10-05,ACTUAL,2020-10-05,,INTERVENTIONAL,COMBI-APlus,,Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes,"COMBI-APlus: Open-label, Phase IIIb Study of Dabrafenib in COMBInation With Trametinib in the Adjuvant Treatment of Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes of an Adapted Pyrexia AE-management Algorithm (Plus)",COMPLETED,,PHASE3,552.0,ACTUAL,Novartis,,1.0,,,f,,,,t,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,INDUSTRY,,,,,,,2021,1.0
NCT03359174,,2017-11-27,2021-06-07,,2021-08-04,2017-11-27,2017-12-02,ACTUAL,2021-08-04,2021-08-09,ACTUAL,,,,2021-08-04,2021-08-09,ACTUAL,2018-05-29,ACTUAL,2018-05-29,2021-08,2021-08-31,2021-01-01,ACTUAL,2021-01-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,,,An Efficacy Trial of Low Dose All-trans Retinoic Acid in Patients With Primary Sclerosing Cholangitis,An Efficacy Trial of Low Dose All-trans Retinoic Acid (ATRA) in Patients With Primary Sclerosing Cholangitis,TERMINATED,,PHASE2,2.0,ACTUAL,Yale University,,1.0,,low recruitment,f,,,,f,t,f,,,,,,,,,,,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,OTHER,,,,,,,2021,0.0
NCT05935332,,2023-06-26,,,2024-07-18,2023-07-04,2023-07-07,ACTUAL,,,,,,,2024-07-18,2024-07-22,ACTUAL,2023-07-05,ACTUAL,2023-07-05,2024-07,2024-07-31,2024-06-21,ACTUAL,2024-06-21,2024-06-21,ACTUAL,2024-06-21,,INTERVENTIONAL,,,Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma,A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 in Adults With Moderate-to-severe T2-high Asthma Who Are Partially Controlled on Inhaled Corticosteroid and Long-acting Beta 2 Agonist Therapy,TERMINATED,,PHASE2,38.0,ACTUAL,"RAPT Therapeutics, Inc.",,2.0,,Study on clinical hold by FDA,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,INDUSTRY,,,,,,,2024,0.0
NCT02430558,,2015-04-25,,,2022-09-23,2015-04-29,2015-04-30,ESTIMATED,,,,,,,2022-09-23,2022-09-27,ACTUAL,2016-04-05,ACTUAL,2016-04-05,2022-09,2022-09-30,2021-06-15,ACTUAL,2021-06-15,2021-06-15,ACTUAL,2021-06-15,,INTERVENTIONAL,ODPHOENIX2,,Second Line Treatment of Knee Osteochondral Lesion With Treated Osteochondral Graft,Second Line Treatment of Knee Osteochondral Lesion With Decellularized Treated Osteochondral Allograft. Phase IIa Trial,TERMINATED,,PHASE1/PHASE2,10.0,ACTUAL,TBF Genie Tissulaire,,1.0,,Low accrual rate,f,,,,t,f,f,,,,,,,,,,,2024-10-17 01:47:52.012187,2024-10-17 01:47:52.012187,INDUSTRY,,,,,,,2021,0.0
NCT04996667,,2021-07-21,,,2022-05-11,2021-07-30,2021-08-09,ACTUAL,,,,,,,2022-05-11,2022-05-18,ACTUAL,2021-06-01,ESTIMATED,2021-06-01,2022-05,2022-05-31,2023-06-30,ESTIMATED,2023-06-30,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Effect of iNO in Patients With Submassive and Massive PE,Study to Evaluate the Role of Inhaled Nitric Oxide (iNO) on Pulmonary Hemodynamics in Patients With Intermediate/Submassive and Massive Pulmonary Embolism (PE),WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, Los Angeles",,2.0,,no sponsor support,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,OTHER,,,,,,,2023,0.0
NCT02977195,,2016-11-25,,,2022-07-22,2016-11-25,2016-11-30,ESTIMATED,,,,,,,2022-07-22,2022-07-25,ACTUAL,2017-01-09,ACTUAL,2017-01-09,2022-05,2022-05-31,2022-06,ACTUAL,2022-06-30,2021-12,ACTUAL,2021-12-31,,INTERVENTIONAL,NP137,,"First in Human Evaluation of Safety, Pharmacokinetics, and Clinical Activity of a Monoclonal Antibody Targeting Netrin 1 in Patients With Advanced/Metastatic Solid Tumors","NP137 - An Open-label, First in Human, Phase I Trial Aiming to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of a Humanized Monoclonal Antibody Targeting Netrin 1 (NP137) in Patients With Advanced/Metastatic Solid Tumors.",COMPLETED,,PHASE1,70.0,ACTUAL,Centre Leon Berard,,1.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,OTHER,,,,,,,2022,1.0
NCT02500121,,2015-07-08,2021-05-26,,2022-09-16,2015-07-15,2015-07-16,ESTIMATED,2022-09-16,2022-09-30,ACTUAL,,,,2022-09-16,2022-09-30,ACTUAL,2015-11-11,ACTUAL,2015-11-11,2022-09,2022-09-30,2021-01-01,ACTUAL,2021-01-01,2019-07-01,ACTUAL,2019-07-01,,INTERVENTIONAL,,One patient randomly assigned to placebo was excluded from the analysis because of inconsistent receipt of pembrolizumab rather than placebo during the initial several cycles of study treatment.,Testing the PD-1 Inhibitor Pembrolizumab as Maintenance Therapy After Initial Chemotherapy in Metastatic Bladder Cancer,"A Randomized, Double-blinded, Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer: Hoosier Cancer Research Network GU14-182",COMPLETED,,PHASE2,108.0,ACTUAL,Hoosier Cancer Research Network,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 03:39:29.394113,2024-10-16 03:39:29.394113,OTHER,,,,,,,2021,1.0
NCT02127658,,2014-04-29,2023-02-27,,2024-05-29,2014-04-29,2014-05-01,ESTIMATED,2024-05-29,2024-06-25,ACTUAL,,,,2024-05-29,2024-06-25,ACTUAL,2016-02-18,ACTUAL,2016-02-18,2024-05,2024-05-31,2020-07-01,ACTUAL,2020-07-01,2020-07-01,ACTUAL,2020-07-01,,INTERVENTIONAL,MEDiC,,MRSA Eradication and Decolonization in Children,MRSA Eradication and Decolonization in Children,TERMINATED,,PHASE4,14.0,ACTUAL,Indiana University,We enrolled 14 subjects with only 9 completing at least one outcome assessment. This was far below the 118 (total) or 59/arm needed for appropriate statistical analysis.,2.0,,Unable to recruit all planned participants prior to end of funding,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 01:47:52.012187,2024-10-17 01:47:52.012187,OTHER,,,,,,,2020,0.0
NCT04078386,,2019-07-18,,,2022-01-07,2019-09-01,2019-09-06,ACTUAL,,,,,,,2022-01-07,2022-01-11,ACTUAL,2019-11-21,ACTUAL,2019-11-21,2022-01,2022-01-31,2021-10-26,ACTUAL,2021-10-26,2021-06-23,ACTUAL,2021-06-23,,INTERVENTIONAL,,,A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome,"A Phase II Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Primary Sjögren's Syndrome",COMPLETED,,PHASE2,42.0,ACTUAL,"RemeGen Co., Ltd.",,3.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-17 01:47:52.012187,2024-10-17 01:47:52.012187,INDUSTRY,,,,,,,2021,1.0
NCT05305040,,2022-03-22,2024-04-19,,2024-04-19,2022-03-30,2022-03-31,ACTUAL,2024-04-19,2024-05-16,ACTUAL,,,,2024-04-19,2024-05-16,ACTUAL,2022-03-24,ACTUAL,2022-03-24,2024-04,2024-04-30,2024-01-30,ACTUAL,2024-01-30,2024-01-30,ACTUAL,2024-01-30,,INTERVENTIONAL,Prevent,Safety Population: included all participants who received at least one dose of posoleucel or placebo.,"Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant","Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 Posoleucel (ALVR105,Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant",TERMINATED,,PHASE2/PHASE3,451.0,ACTUAL,AlloVir,The Sponsor decided to discontinue the Phase 3 part of the trial on 22 Dec 2023 following a pre-planned DSMB futility analysis concluding the study was unlikely to meet its primary endpoint; no safety concerns were identified. Data was not collected for efficacy analyses at Week 26 as planned. Participants were monitored through Week 26 for safety analyses.,2.0,,Study discontinued as DSMB determined it was futile. No safety concerns were noted.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,INDUSTRY,,,,,,,2024,0.0
NCT03817528,,2018-11-30,2021-09-09,,2021-11-02,2019-01-23,2019-01-25,ACTUAL,2021-10-05,2021-11-02,ACTUAL,,,,2021-11-02,2021-11-04,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2021-11,2021-11-30,2020-09-23,ACTUAL,2020-09-23,2020-09-23,ACTUAL,2020-09-23,,INTERVENTIONAL,,Baseline population is participants who received at least one dose of study drug,ITI-007 (Lumateperone Tosylate) for Schizophrenia,ITI-007 (Lumateperone Tosylate) for Schizophrenia,TERMINATED,,PHASE2,4.0,ACTUAL,New York State Psychiatric Institute,,1.0,,ITI-007 approved by FDA,f,,,,f,t,f,,,,,,,,,,,2024-10-17 01:47:52.012187,2024-10-17 01:47:52.012187,OTHER,,,,,,,2020,0.0
NCT03829332,,2019-02-01,2022-05-06,,2024-07-23,2019-02-01,2019-02-04,ACTUAL,2022-05-06,2022-06-02,ACTUAL,,,,2024-07-23,2024-08-14,ACTUAL,2019-03-13,ACTUAL,2019-03-13,2024-07,2024-07-31,2024-04-24,ACTUAL,2024-04-24,2021-05-19,ACTUAL,2021-05-19,,INTERVENTIONAL,,All participants randomized by intention to treat (ITT).,Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007),"A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Nonsmall Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)",COMPLETED,,PHASE3,623.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,INDUSTRY,,,,,,,2024,1.0
NCT00529035,,2007-09-11,2012-08-09,,2020-06-22,2007-09-11,2007-09-14,ESTIMATED,2013-12-11,2014-01-29,ESTIMATED,,,,2020-06-22,2020-07-01,ACTUAL,2007-08,,2007-08-31,2020-06,2020-06-30,2020-05-27,ACTUAL,2020-05-27,2011-06,ACTUAL,2011-06-30,,INTERVENTIONAL,,,Ultra-Low Dose Interleukin-2 for Refractory Chronic Graft Versus Host Disease,A Phase I Study of Ultra-Low Dose Subcutaneous Interleukin-2 (IL-2) for Treatment of Refractory Chronic Graft Versus Host Disease,COMPLETED,,PHASE1,29.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-17 01:47:52.012187,2024-10-17 01:47:52.012187,OTHER,,,,,,,2020,1.0
NCT04914676,,2021-06-03,,,2024-10-03,2021-06-03,2021-06-04,ACTUAL,,,,,,,2024-10-03,2024-10-08,ACTUAL,2022-03-08,ACTUAL,2022-03-08,2024-10,2024-10-31,2024-08-26,ACTUAL,2024-08-26,2024-01-12,ACTUAL,2024-01-12,,INTERVENTIONAL,,,Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) in Complete Remission,Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) in Complete Remission,TERMINATED,,PHASE2,5.0,ACTUAL,University of Florida,,2.0,,PI decision to close study early due to limited data due to accrual goal not being met,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,OTHER,,,,,,,2024,0.0
NCT04797767,,2021-03-10,,,2024-05-20,2021-03-10,2021-03-15,ACTUAL,,,,,,,2024-05-20,2024-05-21,ACTUAL,2022-02-04,ACTUAL,2022-02-04,2024-05,2024-05-31,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms,"A Phase 1 Single-Center Trial Combining Venetoclax With G-CSF, Cladribine, Cytarabine, and Mitoxantrone (CLAG-M) for Patients With AML and High-Grade Myeloid Neoplasms",SUSPENDED,,PHASE1,20.0,ESTIMATED,University of Washington,,1.0,,Phase transition/study design changes - additional phase/cohort/arms pending. Start-up activity temporarily suspended,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,OTHER,,,,,,,2024,0.0
NCT02202304,,2014-07-24,,,2017-05-12,2014-07-27,2014-07-29,ESTIMATED,,,,,,,2017-05-12,2017-05-15,ACTUAL,2017-09-10,ESTIMATED,2017-09-10,2017-05,2017-05-31,2020-12-10,ESTIMATED,2020-12-10,2019-09-10,ESTIMATED,2019-09-10,,INTERVENTIONAL,,,The Effects of Chlorhexidine/Thymol Varnish on Partial Denture Patient,The Effects of Chlorhexidine/Thymol Varnish on the Abutment Teeth in Partial Denture Wearers.,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Aberdeen,,2.0,,Researcher changed jobs. Unable to carry out the project,f,,,,t,f,f,,,,,,,,,YES,within 6 months,2024-10-17 01:47:52.012187,2024-10-17 01:47:52.012187,OTHER,,,,,,,2020,0.0
NCT04066751,,2019-08-19,,,2022-01-11,2019-08-22,2019-08-26,ACTUAL,,,,,,,2022-01-11,2022-01-27,ACTUAL,2021-12-01,ESTIMATED,2021-12-01,2022-01,2022-01-31,2024-10-31,ESTIMATED,2024-10-31,2024-10-31,ESTIMATED,2024-10-31,,INTERVENTIONAL,,,The Multicenter Topic Trial,"A Multicenter Randomized, Double-blind, Phase 2, Placebo Controlled Study to Determine the Safety and Efficacy of Ivacaftor (VX-770) for the Treatment of Chronic Obstructive Pulmonary Disease (The Multicenter Topic Trial)",WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Alabama at Birmingham,,2.0,,Study never started due to change in availability of study drug,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,OTHER,,,,,,,2024,0.0
NCT03912350,,2019-04-10,,,2022-02-07,2019-04-10,2019-04-11,ACTUAL,,,,,,,2022-02-07,2022-02-08,ACTUAL,2022-06-26,ESTIMATED,2022-06-26,2022-02,2022-02-28,2022-10-13,ESTIMATED,2022-10-13,2022-09-24,ESTIMATED,2022-09-24,,INTERVENTIONAL,,,The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan,"The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan: A Phase I, Multiple-Center, Open-Label Study Following Multiple Daily Oral Doses of Balovaptan in Subjects With Moderate Hepatic Impairment and Healthy Subjects With Normal Hepatic Function",WITHDRAWN,,PHASE1,0.0,ACTUAL,Hoffmann-La Roche,,2.0,,"The study is on hold due to stopping of the Autism Spectrum Disorder program with balovatpan, the study drug.",f,,,,f,t,f,,,,,,,,,NO,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,INDUSTRY,,,,,,,2022,0.0
NCT05074498,,2021-09-24,2023-10-04,,2023-11-15,2021-10-07,2021-10-12,ACTUAL,2023-11-15,2023-11-18,ACTUAL,,,,2023-11-15,2023-11-18,ACTUAL,2021-10-08,ACTUAL,2021-10-08,2023-11,2023-11-30,2022-10-13,ACTUAL,2022-10-13,2022-10-13,ACTUAL,2022-10-13,,INTERVENTIONAL,,Safety Analysis Set comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.,"Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease","A Seamless Phase 1b/2a Double-blind, Randomized, Multiple Dose, Multi-center, Sequential Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of TB006 in Patients With Mild to Severe Alzheimer's Disease",COMPLETED,,PHASE1/PHASE2,154.0,ACTUAL,"TrueBinding, Inc.",,4.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,INDUSTRY,,,,,,,2022,1.0
NCT03503773,,2018-03-23,2023-11-10,,2024-06-20,2018-04-13,2018-04-20,ACTUAL,2024-06-20,2024-10-04,ACTUAL,,,,2024-06-20,2024-10-04,ACTUAL,2018-09-24,ACTUAL,2018-09-24,2024-06,2024-06-30,2024-01-10,ACTUAL,2024-01-10,2022-01-31,ACTUAL,2022-01-31,,INTERVENTIONAL,,,The TARGET BP OFF-MED Trial,"A Phase 2, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects With Hypertension, in the Absence of Antihypertensive Medications",COMPLETED,,PHASE2,350.0,ACTUAL,"Ablative Solutions, Inc.",,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,INDUSTRY,,,,,,,2024,1.0
NCT03980730,,2019-05-31,2021-11-16,,2021-12-21,2019-06-06,2019-06-10,ACTUAL,2021-12-21,2022-01-21,ACTUAL,,,,2021-12-21,2022-01-21,ACTUAL,2019-06-27,ACTUAL,2019-06-27,2021-12,2021-12-31,2021-01-29,ACTUAL,2021-01-29,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,Elevage,,Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance,"Randomized, Double-blind, Placebo-controlled, Multicenter Studies to Evaluate the Safety and Efficacy of Azeliragon as a Treatment for Subjects With Mild Alzheimer's Disease and Impaired Glucose Tolerance",TERMINATED,,PHASE2,43.0,ACTUAL,vTv Therapeutics,,2.0,,for business reasons,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,INDUSTRY,,,,,,,2021,0.0
NCT03437668,,2018-02-01,2024-08-22,,2024-09-27,2018-02-12,2018-02-19,ACTUAL,2024-09-27,2024-10-08,ACTUAL,,,,2024-09-27,2024-10-08,ACTUAL,2018-12-01,ACTUAL,2018-12-01,2024-09,2024-09-30,2023-06-12,ACTUAL,2023-06-12,2023-06-12,ACTUAL,2023-06-12,,INTERVENTIONAL,,,Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia,Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia,TERMINATED,,PHASE2/PHASE3,47.0,ACTUAL,University of Pittsburgh,,2.0,,Unable to reach enrollment target due to COVID,f,,,,t,t,f,,,,,,,,,UNDECIDED,Deidentified will be submitted an NIH repository,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,OTHER,,,,,,,2023,0.0
NCT04536077,,2020-08-27,2024-08-30,,2024-09-30,2020-08-27,2020-09-02,ACTUAL,2024-09-30,2024-10-08,ACTUAL,,,,2024-09-30,2024-10-08,ACTUAL,2021-08-13,ACTUAL,2021-08-13,2024-09,2024-09-30,2023-11-21,ACTUAL,2023-11-21,2023-11-21,ACTUAL,2023-11-21,,INTERVENTIONAL,,,Immunologic Effects of CDX-301 and CDX-1140 in Resectable Pancreatic Cancer Patients,Testing the Immunologic Effects of CDX-301 and CDX-1140 in Resectable Pancreatic Cancer Patients,TERMINATED,,PHASE2,16.0,ACTUAL,Washington University School of Medicine,,2.0,,Celldex decision,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,OTHER,,,,,,,2023,0.0
NCT04408183,,2020-05-22,,,2023-02-18,2020-05-27,2020-05-29,ACTUAL,,,,,,,2023-02-18,2023-02-21,ACTUAL,2020-06-10,ACTUAL,2020-06-10,2023-02,2023-02-28,2023-01-10,ACTUAL,2023-01-10,2023-01-10,ACTUAL,2023-01-10,,INTERVENTIONAL,,,GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19),"Efficacy, Safety, and Tolerability of GLS-1200 Topical Nasal Spray in the Prevention of Incident Confirmed, Symptomatic SARS-CoV-2 Infection",TERMINATED,,PHASE2,184.0,ACTUAL,"GeneOne Life Science, Inc.",,2.0,,No longer enrolling,f,,,,f,t,f,,,,,,,,,,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,INDUSTRY,,,,,,,2023,0.0
NCT05167253,,2021-12-16,,,2022-08-25,2021-12-21,2021-12-22,ACTUAL,,,,,,,2022-08-25,2022-08-26,ACTUAL,2022-02-15,ESTIMATED,2022-02-15,2022-02,2022-02-28,2022-10-31,ESTIMATED,2022-10-31,2022-04-15,ESTIMATED,2022-04-15,,INTERVENTIONAL,,,A Study to Evaluate the Ability of UB-612 COVID-19 Vaccine to Boost Immunity of Heterologous COVID-19 Vaccines.,"A Phase I, Open-label Study to Evaluate the Ability of UB-612 Vaccine to Boost Immunity of Heterologous COVID-19 Vaccines",WITHDRAWN,,PHASE1,0.0,ACTUAL,"United Biomedical Inc., Asia",,1.0,,Regulatory issues raised by the regulatory authority in Taiwan.,f,,,,,f,f,,,,,,,,,,,2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,INDUSTRY,,,,,,,2022,0.0
NCT04444752,,2020-06-15,2022-11-09,,2023-07-31,2020-06-20,2020-06-24,ACTUAL,2023-07-31,2023-08-01,ACTUAL,,,,2023-07-31,2023-08-01,ACTUAL,2020-07-17,ACTUAL,2020-07-17,2023-07,2023-07-31,2021-09-22,ACTUAL,2021-09-22,2021-07-28,ACTUAL,2021-07-28,,INTERVENTIONAL,,,A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis,"A Randomized, Double-Blind, Placebo-Controlled Multi-Centered Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis",COMPLETED,,PHASE2,226.0,ACTUAL,"Suzhou Connect Biopharmaceuticals, Ltd.",,4.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,INDUSTRY,,,,,,,2021,1.0
NCT03724968,,2018-10-26,2021-02-12,,2021-03-26,2018-10-29,2018-10-30,ACTUAL,2021-02-12,2021-03-05,ACTUAL,,,,2021-03-26,2021-04-20,ACTUAL,2019-01-17,ACTUAL,2019-01-17,2021-03,2021-03-31,2020-05-28,ACTUAL,2020-05-28,2020-05-28,ACTUAL,2020-05-28,,INTERVENTIONAL,,Study stopped early due to low accrual and no participants were enrolled to Arm A,Nivolumab Plus Relatlimab or Ipilimumab in Metastatic Melanoma Stratified by MHC-II Expression,A Phase II Two-Arm Open-Label Study of Nivolumab Plus Relatlimab or Ipilimumab in Metastatic Melanoma Stratified by MHC-II Expression,TERMINATED,,PHASE2,2.0,ACTUAL,Vanderbilt-Ingram Cancer Center,,2.0,,Loss of funding,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,OTHER,,,,,,,2020,0.0
NCT02711826,,2016-03-11,2024-06-06,,2024-09-26,2016-03-11,2016-03-17,ESTIMATED,2024-09-26,2024-10-08,ACTUAL,,,,2024-09-26,2024-10-08,ACTUAL,2016-09-20,ACTUAL,2016-09-20,2024-09,2024-09-30,2023-08-04,ACTUAL,2023-08-04,2023-08-04,ACTUAL,2023-08-04,,INTERVENTIONAL,TASK,"Intent-to-treat population who initiated study treatment, reflecting reassignment of participants from either the polyTregs or darTregs group to the Maintenance group.",Treg Therapy in Subclinical Inflammation in Kidney Transplantation,Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation (CTOT-21),COMPLETED,,PHASE1/PHASE2,32.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,,f,,,,t,,,,,,,,,,,YES,"The plan is to share data in ImmPort \[https://immport.niaid.nih.gov/ \], a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts, upon completion of the study.",2024-10-15 16:54:51.754519,2024-10-15 16:54:51.754519,NIH,,,,,,,2023,1.0
NCT04311489,,2020-03-12,,,2023-05-16,2020-03-16,2020-03-17,ACTUAL,,,,,,,2023-05-16,2023-05-18,ACTUAL,2020-08-01,ACTUAL,2020-08-01,2022-05,2022-05-31,2022-11-30,ACTUAL,2022-11-30,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,ULA04,,"Refractory Ascites in Patients With Liver Cirrhosis, and the Potential Treatment With 48 Hours Infusion of Ularitide.","Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial for the Safety, Tolerability and Efficacy of Ularitide in Cirrhosis Patients With Refractory Ascites.",TERMINATED,,PHASE2,17.0,ACTUAL,University of Aarhus,,2.0,,Interim analysis showing safety concerns,f,,,,t,f,f,,,,,,,,,,,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,OTHER,,,,,,,2022,0.0
NCT04102618,,2019-09-23,,,2022-08-10,2019-09-24,2019-09-25,ACTUAL,,,,,,,2022-08-10,2022-08-15,ACTUAL,2019-03-29,ACTUAL,2019-03-29,2022-08,2022-08-31,2022-04-20,ACTUAL,2022-04-20,2022-04-20,ACTUAL,2022-04-20,,INTERVENTIONAL,AWARE-1,,A Window-of-opportunity Study of Pelareorep in Early Breast Cancer,A Window-of-opportunity Study of Pelareorep in Early Breast Cancer (AWARE-1),TERMINATED,,EARLY_PHASE1,26.0,ACTUAL,Oncolytics Biotech,,6.0,,Enrollment into AWARE cohorts1-4 have concluded and the primary objective and core goals for the study were met.,f,,,,t,f,f,,,,,,,,,,,2024-10-17 01:47:52.012187,2024-10-17 01:47:52.012187,INDUSTRY,,,,,,,2022,0.0
NCT04469465,,2020-07-09,2023-06-28,,2024-02-01,2020-07-09,2020-07-14,ACTUAL,2023-07-21,2023-07-24,ACTUAL,,,,2024-02-01,2024-02-06,ACTUAL,2020-12-16,ACTUAL,2020-12-16,2024-02,2024-02-29,2024-01-16,ACTUAL,2024-01-16,2022-06-29,ACTUAL,2022-06-29,,INTERVENTIONAL,,The safety set included all participants that received at least 1 dose of study drug (danicopan or placebo).,Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA),A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH),COMPLETED,,PHASE3,86.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,2.0,,,,,,,t,t,f,,,,,,,,,,,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,INDUSTRY,,,,,,,2024,1.0
NCT03920254,,2019-03-28,2022-10-10,,2022-10-10,2019-04-15,2019-04-18,ACTUAL,2022-10-10,2022-11-02,ACTUAL,,,,2022-10-10,2022-11-02,ACTUAL,2020-07-23,ACTUAL,2020-07-23,2022-10,2022-10-31,2021-10-27,ACTUAL,2021-10-27,2021-10-27,ACTUAL,2021-10-27,,INTERVENTIONAL,,The Baseline Analysis Population includes all participants from the Safety Analysis Set. The Safety Analysis Set includes all participants who received at least one dose of study drug.,TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study,"A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects With Ulcerative Colitis (UC)",TERMINATED,,PHASE2/PHASE3,46.0,ACTUAL,Theravance Biopharma,Study 0164 was terminated early because Study 0157 was terminated early and participation in Study 0164 was predicated on participation in Study 0157.,3.0,,Stopped early due to company decision. Company decision based on interim analysis results in TD-1473-0157.,f,,,,t,t,f,,,,,,,,,NO,"Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.",2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,INDUSTRY,,,,,,,2021,0.0
NCT04056299,,2019-08-12,2022-02-03,,2022-02-28,2019-08-12,2019-08-14,ACTUAL,2022-02-03,2022-02-28,ACTUAL,,,,2022-02-28,2022-03-10,ACTUAL,2019-08-20,ACTUAL,2019-08-20,2022-02,2022-02-28,2020-12-28,ACTUAL,2020-12-28,2020-12-16,ACTUAL,2020-12-16,,INTERVENTIONAL,,,"Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy","Phase 2 Study of AR201 Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy",TERMINATED,,PHASE2,15.0,ACTUAL,"Aimmune Therapeutics, Inc.",,2.0,,"The study was prematurely terminated by the Sponsor based on difficulties in meeting enrollment goals, especially during the COVID-19 pandemic, and not for reasons relating to any concerns regarding quality, safety, or efficacy.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,INDUSTRY,,,,,,,2020,0.0
NCT03040726,,2017-01-31,2023-02-07,,2023-09-25,2017-02-01,2017-02-02,ESTIMATED,2023-09-25,2023-10-17,ACTUAL,,,,2023-09-25,2023-10-17,ACTUAL,2017-05-03,ACTUAL,2017-05-03,2023-09,2023-09-30,2022-02-14,ACTUAL,2022-02-14,2022-02-14,ACTUAL,2022-02-14,,INTERVENTIONAL,,We have 2 arms in this study (intervention group and Placebo group) during randomization. These 2 arms included all participants who entered in Placebo run out phase. Baseline characteristics thus have 2 arms/groups.,Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer,Fixed-Dose Netupitant and Palonosetron for Chronic Nausea and Vomiting in Cancer Patients,COMPLETED,,PHASE2/PHASE3,53.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2022,1.0
NCT04031066,,2019-07-17,,,2020-12-04,2019-07-22,2019-07-24,ACTUAL,,,,,,,2020-12-04,2020-12-08,ACTUAL,2021-01-11,ESTIMATED,2021-01-11,2020-12,2020-12-31,2021-12-29,ESTIMATED,2021-12-29,2021-10-27,ESTIMATED,2021-10-27,,INTERVENTIONAL,SHAMAN,,Interventional Study to Assess Efficacy and Safety of Velmanase Alfa in Patients With Alpha Mannosidosis,"A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Velmanase Alfa in Patients With Alpha Mannosidosis",WITHDRAWN,,PHASE3,0.0,ACTUAL,Chiesi Farmaceutici S.p.A.,,2.0,,"Big delay on study activation (approval procedures by IRBs, hospitals contract negotiation) and on enrolment deadline due to CoViD-19; Placebo stock expires November 2021 and new batch not be available for at least one year",f,,,,,t,f,,,,,,,,,NO,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,INDUSTRY,,,,,,,2021,0.0
NCT04531865,,2020-08-26,,,2020-12-25,2020-08-26,2020-08-31,ACTUAL,,,,,,,2020-12-25,2020-12-29,ACTUAL,2021-01-01,ESTIMATED,2021-01-01,2020-12,2020-12-31,2022-10-01,ESTIMATED,2022-10-01,2022-09-01,ESTIMATED,2022-09-01,,INTERVENTIONAL,,,Randomized Trial Evaluating Mycophenolate Mofetil in Children With Nephrotic Syndrome After Rituximab Treatment,"Efficacy and Safety of Mycophenolate Mofetil as Maintenance Therapy After Rituximab Treatment in Childhood-onset, Frequently-relapsing or Steroid-dependent Nephrotic Syndrome: a Multicenter Double-blind, Randomized, Placebo-controlled Trial",WITHDRAWN,,PHASE3,0.0,ACTUAL,Children's Hospital of Fudan University,,2.0,,lack of funding,f,,,,,f,f,,,,,,,,,,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2022,0.0
NCT03080935,,2017-03-10,2022-11-17,,2024-05-10,2017-03-10,2017-03-15,ACTUAL,2022-12-19,2023-01-11,ACTUAL,,,,2024-05-10,2024-05-29,ACTUAL,2017-03-13,ACTUAL,2017-03-13,2024-05,2024-05-31,2022-03-04,ACTUAL,2022-03-04,2022-03-04,ACTUAL,2022-03-04,,INTERVENTIONAL,,The Overall Number of Baseline Participants is made up of all of the participants that received study drug.,Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries,"A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries",TERMINATED,,PHASE3,1600.0,ACTUAL,Amgen,This study was terminated to coincide with the completion of study 20130295 (NCT02867813). The study was not terminated due to any safety findings.,1.0,,Amgen business decision to close study early,f,,,,f,t,f,,,t,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,INDUSTRY,,,,,,,2022,0.0
NCT04607200,,2020-10-16,,,2021-12-21,2020-10-22,2020-10-29,ACTUAL,,,,,,,2021-12-21,2022-01-11,ACTUAL,2021-02,ESTIMATED,2021-02-28,2021-12,2021-12-31,2021-09-13,ACTUAL,2021-09-13,2021-09-13,ACTUAL,2021-09-13,,INTERVENTIONAL,,,"AGEN2034 & AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma","A Phase 2 Study Examining AGEN2034 as a Single-Agent and in Combination With AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma",WITHDRAWN,,PHASE2,0.0,ACTUAL,Agenus Inc.,,2.0,,Strategic business decision,,,,,f,t,f,,,,,,,,,,,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,INDUSTRY,,,,,,,2021,0.0
NCT01803438,,2013-03-01,,,2020-02-24,2013-03-01,2013-03-04,ESTIMATED,,,,,,,2020-02-24,2020-02-25,ACTUAL,2014-06,,2014-06-30,2020-02,2020-02-29,2020-01-20,ACTUAL,2020-01-20,2019-10-16,ACTUAL,2019-10-16,,INTERVENTIONAL,,,Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation,Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation.,COMPLETED,,PHASE4,220.0,ACTUAL,Medtronic Cardiac Rhythm and Heart Failure,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,INDUSTRY,,,,,,,2020,1.0
NCT02389959,,2015-03-11,2021-01-23,,2021-08-06,2015-03-11,2015-03-17,ESTIMATED,2021-01-23,2021-02-15,ACTUAL,,,,2021-08-06,2021-09-01,ACTUAL,2014-08-04,ACTUAL,2014-08-04,2021-08,2021-08-31,2020-01-23,ACTUAL,2020-01-23,2020-01-23,ACTUAL,2020-01-23,,INTERVENTIONAL,,1 participant did not complete the baseline questionnaires.,Intranasal Bevacizumab for HHT-Related Epistaxis,Intranasal Bevacizumab for HHT-Related Epistaxis,COMPLETED,,PHASE4,40.0,ACTUAL,Stanford University,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2020,1.0
NCT04327388,,2020-03-26,2021-04-28,,2022-03-15,2020-03-26,2020-03-31,ACTUAL,2021-05-11,2021-05-13,ACTUAL,,,,2022-03-15,2022-03-17,ACTUAL,2020-03-28,ACTUAL,2020-03-28,2022-03,2022-03-31,2020-09-02,ACTUAL,2020-09-02,2020-07-31,ACTUAL,2020-07-31,,INTERVENTIONAL,,Analysis was performed on randomized population.,Sarilumab COVID-19,"An Adaptive Phase 3, Randomized, Double-blind, Placebo-controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID19",COMPLETED,,PHASE3,420.0,ACTUAL,Sanofi,,3.0,,,f,,,,t,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,INDUSTRY,,,,,,,2020,1.0
NCT03513952,,2018-05-01,2024-04-19,,2024-07-02,2018-05-01,2018-05-02,ACTUAL,2024-06-06,2024-07-03,ACTUAL,,,,2024-07-02,2024-07-26,ACTUAL,2019-06-05,ACTUAL,2019-06-05,2024-05,2024-05-31,2024-04-01,ACTUAL,2024-04-01,2023-09-30,ACTUAL,2023-09-30,,INTERVENTIONAL,,,"Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma",A Randomized Phase II Study of Atezolizumab (MPDL3280A) Plus Recombinant Human IL7 (CYT107) in Patients With Locally Advanced or Metastatic Urothelial Carcinoma,COMPLETED,,PHASE2,47.0,ACTUAL,National Cancer Institute (NCI),,3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,NIH,,,,,,,2024,1.0
NCT05033132,,2021-08-27,,,2024-03-27,2021-08-27,2021-09-02,ACTUAL,,,,,,,2024-03-27,2024-03-28,ACTUAL,2021-10-01,ACTUAL,2021-10-01,2024-03,2024-03-31,2024-12-30,ESTIMATED,2024-12-30,2024-12-30,ESTIMATED,2024-12-30,,INTERVENTIONAL,,,A Phase II Study of Balstilimab Independently or in Combination With Zalifrelimab in Advanced Cervical Cancer,"An Open-label, Multicenter Phase II Study Evaluating Balstilimab Alone or Balstilimab in Combination With Zalifrelimab in Patients With Advanced Cervical Cancer",WITHDRAWN,,PHASE2,0.0,ACTUAL,Agenus Inc.,,2.0,,Study was never initiated.,,,,,,t,f,,,,,,,,,,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,INDUSTRY,,,,,,,2024,0.0
NCT02774317,,2015-12-01,,,2018-10-22,2016-05-12,2016-05-17,ESTIMATED,,,,,,,2018-10-22,2018-10-24,ACTUAL,2017-10,ESTIMATED,2017-10-31,2018-10,2018-10-31,2020-12,ESTIMATED,2020-12-31,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,Pilot Study to Compare Fresh Frozen Plasma With 24-Hour Plasma in Babies Up to Age Six Months,A Pilot Study to Compare the Use of Fresh Frozen Plasma With 24-Hour Plasma in Babies Up to Age Six Months,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Chicago,,2.0,,The clinical team couldn't recruit patients who met the criteria for enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2020,0.0
NCT05703555,,2022-12-13,,,2024-02-23,2023-01-26,2023-01-30,ACTUAL,,,,,,,2024-02-23,2024-02-28,ACTUAL,2024-02-16,ACTUAL,2024-02-16,2024-02,2024-02-29,2024-02-16,ACTUAL,2024-02-16,2024-02-16,ACTUAL,2024-02-16,,INTERVENTIONAL,INTRUSION,,INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701,INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701,WITHDRAWN,,PHASE2,0.0,ACTUAL,Erasmus Medical Center,,1.0,,Due to the decision to discontinue the global clinical development program of tusamitamab ravtansine,f,,,,f,f,f,,,,,,Within 12 months of last visit of last patient,,,YES,By means of a publication in a peer-reviewed international journal,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,OTHER,,,,,,,2024,0.0
NCT03229499,,2017-07-18,2024-02-20,2023-06-28,2024-04-03,2017-07-21,2017-07-25,ACTUAL,2024-04-03,2024-05-01,ACTUAL,,2024-05-01,ACTUAL,2024-04-03,2024-05-01,ACTUAL,2017-12-07,ACTUAL,2017-12-07,2024-04,2024-04-30,2022-07-22,ACTUAL,2022-07-22,2022-07-22,ACTUAL,2022-07-22,,INTERVENTIONAL,PHANTOM,,Pulmonary Hypertension and Anastrozole Trial,Pulmonary Hypertension and Anastrozole Trial (PHANTOM),COMPLETED,,PHASE2,84.0,ACTUAL,University of Pennsylvania,,2.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2022,0.0
NCT03735290,,2018-11-07,,,2022-03-01,2018-11-07,2018-11-08,ACTUAL,,,,,,,2022-03-01,2022-03-16,ACTUAL,2019-01-14,ACTUAL,2019-01-14,2022-03,2022-03-31,2021-12-03,ACTUAL,2021-12-03,2021-12-03,ACTUAL,2021-12-03,,INTERVENTIONAL,ILIAD,,A Study to Evaluate the Safety and Effectiveness of ILIxadencel Administered Into Tumors in Combination With Checkpoint Inhibitor (CPI) in Patients With ADvanced Cancer,"A Randomized, Open-label, Multi-center, Phase 1b/2 Trial Evaluating the Safety and Efficacy of Intratumorally-administered Ilixadencel in Combination With Checkpoint Inhibitor (CPI) in Advanced Cancer Subjects Who Are Candidates for CPI Therapy",TERMINATED,,PHASE1,21.0,ACTUAL,Mendus,,6.0,,Decision made not to move to Phase 2,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,INDUSTRY,,,,,,,2021,0.0
NCT01066234,,2010-02-08,,,2021-03-18,2010-02-09,2010-02-10,ESTIMATED,,,,,,,2021-03-18,2021-03-22,ACTUAL,2017-10-23,ACTUAL,2017-10-23,2021-03,2021-03-31,2021-01-18,ACTUAL,2021-01-18,2021-01-18,ACTUAL,2021-01-18,,INTERVENTIONAL,,,Adjuvant CCRT vs CT in Minimal N2 NSCLC,A Randomized Phase II Study of Adjuvant Concurrent Chemoradiotherapy vs Chemotherapy Alone in Completely Resected Microscopic N2 Non-small Cell Lung Cancer,COMPLETED,,PHASE2,17.0,ACTUAL,Samsung Medical Center,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2021,0.0
NCT02659943,,2016-01-20,2021-02-22,,2023-03-24,2016-01-20,2016-01-21,ESTIMATED,2021-04-14,2021-05-04,ACTUAL,,,,2023-03-24,2023-04-19,ACTUAL,2016-01-21,ACTUAL,2016-01-21,2023-03,2023-03-31,2022-12-31,ACTUAL,2022-12-31,2018-06-12,ACTUAL,2018-06-12,,INTERVENTIONAL,,Baseline data was collected and reported here for the participants enrolled but not treated.,T Cells Expressing a Fully-human AntiCD19 Chimeric Antigen Receptor for Treating B-cell Malignancies,T Cells Expressing a Fully-Human Anti-CD19 Chimeric Antigen Receptor for Treating B-cell Malignancies,COMPLETED,,PHASE1,27.0,ACTUAL,National Institutes of Health Clinical Center (CC),,6.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,NIH,,,,,,,2022,1.0
NCT00774345,,2008-10-16,2021-10-27,,2021-11-24,2008-10-16,2008-10-17,ESTIMATED,2021-11-24,2021-12-02,ACTUAL,,,,2021-11-24,2021-12-02,ACTUAL,2009-01-27,ACTUAL,2009-01-27,2021-11,2021-11-30,2020-10-27,ACTUAL,2020-10-27,2020-10-27,ACTUAL,2020-10-27,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy,"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia Following Second-Line Therapy (The Continuum Trial)",COMPLETED,,PHASE3,317.0,ACTUAL,Celgene,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,INDUSTRY,,,,,,,2020,1.0
NCT05387642,,2022-05-13,,,2022-11-28,2022-05-19,2022-05-24,ACTUAL,,,,,,,2022-11-28,2022-11-30,ACTUAL,2022-04-05,ACTUAL,2022-04-05,2022-11,2022-11-30,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,,A Clinical Trial of PRAX-114 in Participants With Essential Tremor,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Explore the Safety, Tolerability, Pharmacokinetics, and Efficacy of PRAX-114 in the Treatment of Adults With Essential Tremor",WITHDRAWN,,PHASE2,0.0,ACTUAL,Praxis Precision Medicines,,4.0,,Sponsor no longer pursuing indication.,f,,,,f,t,f,,,,,,,,,,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,INDUSTRY,,,,,,,2022,0.0
NCT01981551,,2013-10-31,2019-11-25,,2024-01-11,2013-11-08,2013-11-11,ESTIMATED,2020-01-23,2020-02-05,ACTUAL,,,,2024-01-11,2024-02-06,ACTUAL,2013-10-31,ACTUAL,2013-10-31,2024-01,2024-01-31,2023-12-01,ACTUAL,2023-12-01,2018-12-30,ACTUAL,2018-12-30,,INTERVENTIONAL,,,Phase II Trial of the Gamma-Secretase Inhibitor PF-03084014 in Adults With Desmoid Tumors/Aggressive Fibromatosis,Phase II Trial of the Gamma-Secretase Inhibitor PF-03084014 in Adults With Desmoid Tumors/Aggressive Fibromatosis,COMPLETED,,PHASE2,17.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,,f,,,,f,t,f,,,,,,Clinical data available during the study and indefinitely.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).,,YES,All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.,2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,NIH,,,,,,,2023,1.0
NCT04510428,,2020-08-06,,,2023-05-19,2020-08-11,2020-08-12,ACTUAL,,,,,,,2023-05-19,2023-05-23,ACTUAL,2023-05-15,ESTIMATED,2023-05-15,2023-05,2023-05-31,2024-01-20,ESTIMATED,2024-01-20,2023-11-30,ESTIMATED,2023-11-30,,INTERVENTIONAL,,,OSIG-eye Drops Treatment for Dry Eye Disease,"A Phase II Randomized Placebo-Controlled, Double Blind, Single-Center, Tolerability and Efficacy Clinical Trial of Ocular Surface Immunoglobulin (OSIG) Eye Drops In Patients With Dry Eye Disease",WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Illinois at Chicago,,2.0,,Study not initiated.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,OTHER,,,,,,,2024,0.0
NCT04996030,,2021-08-03,,,2024-01-22,2021-08-03,2021-08-09,ACTUAL,,,,,,,2024-01-22,2024-01-23,ACTUAL,2021-09-17,ACTUAL,2021-09-17,2024-01,2024-01-31,2024-04,ESTIMATED,2024-04-30,2024-01-03,ACTUAL,2024-01-03,,INTERVENTIONAL,,,A Study for Oral SY-2101 for Participants With Acute Promyelocytic Leukemia,"An Open-label Phase 1 Study to Evaluate Pharmacokinetics, Safety, and Tolerability of SY-2101 in Adult Patients With Acute Promyelocytic Leukemia",SUSPENDED,,PHASE1,16.0,ACTUAL,Syros Pharmaceuticals,,5.0,,Prioritization,,,,,f,t,f,,,,,,,,,NO,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,INDUSTRY,,,,,,,2024,0.0
NCT04809116,,2021-03-15,,,2023-03-23,2021-03-19,2021-03-22,ACTUAL,,,,,,,2023-03-23,2023-03-24,ACTUAL,2022-12-15,ESTIMATED,2022-12-15,2023-03,2023-03-31,2023-12-15,ESTIMATED,2023-12-15,2023-12-15,ESTIMATED,2023-12-15,,INTERVENTIONAL,,,Pimavanserin for Insomnia in Veterans With Posttraumatic Stress Disorder: Proof of Concept,Open-label Pimavanserin 34mg at Bedtime for 6 Weeks for Insomnia in Veterans With Post-traumatic Stress Disorder: Proof of Concept Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,Baylor College of Medicine,,1.0,,Received alternative sources of funding.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2023,0.0
NCT03529773,,2018-04-17,2020-11-18,,2022-03-01,2018-05-07,2018-05-18,ACTUAL,2021-02-11,2021-03-04,ACTUAL,,,,2022-03-01,2022-03-03,ACTUAL,2018-04-18,ACTUAL,2018-04-18,2022-03,2022-03-31,2020-12-28,ACTUAL,2020-12-28,2019-11-20,ACTUAL,2019-11-20,,INTERVENTIONAL,,Safety analysis set included all participants in the sentinel and expanded cohorts who received at least 1 dose of the investigational products.,A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults,"A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING, FIRST-IN-HUMAN STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN HEALTHY ADULTS",COMPLETED,,PHASE2,1235.0,ACTUAL,Pfizer,,20.0,,,f,,,,t,t,f,,,,,,Starting 24 months after study completion.,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,INDUSTRY,,,,,,,2020,1.0
NCT03742596,,2018-11-11,,,2023-03-13,2018-11-14,2018-11-15,ACTUAL,,,,,,,2023-03-13,2023-03-15,ACTUAL,2018-11-07,ACTUAL,2018-11-07,2023-03,2023-03-31,2022-12-30,ESTIMATED,2022-12-30,2022-09-30,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,Effect of Probiotics Supplementation on the Side Effects of Radiation Therapy Among Colorectal Cancer Patients,Effect of Probiotics Supplementation on the Side Effects of Radiation Therapy on the Immune System Among Colorectal Cancer Patients,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,King Hussein Cancer Center,,2.0,,This study was closed without recruitment,f,,,,t,t,f,,,t,,,,,,NO,The center (KHCC) where the study conducted emphasis of maintaining privacy and confidentiality of the participants' data,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2022,0.0
NCT04360759,,2020-04-22,,,2020-08-14,2020-04-22,2020-04-24,ACTUAL,,,,,,,2020-08-14,2020-08-18,ACTUAL,2020-05-01,ESTIMATED,2020-05-01,2020-08,2020-08-31,2021-06-30,ESTIMATED,2021-06-30,2021-05-30,ESTIMATED,2021-05-30,,INTERVENTIONAL,CQOTE,,Chloroquine Outpatient Treatment Evaluation for HIV-Covid-19,Multi-centre Randomised Controlled Trial of Chloroquine/Hydroxychloroquine Versus Standard of Care for Treatment of Mild Covid-19 in HIV-positive Outpatients in South Africa,WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Cape Town,,2.0,,Equipoise for hydroxychloquine was lost,f,,,,t,f,f,,,,,,"Recruitment period is planned for a maximum of 12 months, rate dependent on patient numbers. Additional sites will be opened after initial approvals.",,,YES,"Data collected from this study may be made available to other international researchers and institutions who are working to control this Public Health Emergency, but in a fully anonymized way. No personal identifiers will be available anywhere in the data. Dates will either not be included or will be shifted by a random interval so as to not make it possible to trace any identity.",2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,OTHER,,,,,,,2021,0.0
NCT03217838,,2017-07-13,,,2022-03-24,2017-07-13,2017-07-14,ACTUAL,,,,,,,2022-03-24,2022-04-05,ACTUAL,2017-07-31,ACTUAL,2017-07-31,2022-03,2022-03-31,2021-03-25,ACTUAL,2021-03-25,2021-03-25,ACTUAL,2021-03-25,,INTERVENTIONAL,,,"Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticles as Monotherapy or in Combination in Acute Myeloid Leukemia Participants.","A Phase I/II, Open-Label, Multicentre 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 as Monotherapy or in Combination in Treatment-Naïve or Relapsed/Refractory Acute Myeloid Leukaemia Patients Not Eligible for Intensive Induction Therapy.",TERMINATED,,PHASE1,50.0,ACTUAL,AstraZeneca,,13.0,,strategic decision,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,INDUSTRY,,,,,,,2021,0.0
NCT03275740,,2017-07-06,2024-01-05,,2024-01-05,2017-09-05,2017-09-08,ACTUAL,2024-01-05,2024-07-05,ACTUAL,,,,2024-01-05,2024-07-05,ACTUAL,2017-07-17,ACTUAL,2017-07-17,2024-01,2024-01-31,2023-01-06,ACTUAL,2023-01-06,2023-01-06,ACTUAL,2023-01-06,,INTERVENTIONAL,,,"A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347","A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO -CONTROLLED, FIRST-IN-HUMAN TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF 06755347 AFTER SINGLE ASCENDING INTRAVENOUS AND SUBCUTANEOUS DOSING IN HEALTHY ADULT MALE PARTICIPANTS AND OPEN-LABEL AFTER SINGLE SUBCUTANEOUS DOSING IN MALE AND FEMALE PARTICIPANTS WITH PERSISTENT OR CHRONIC PRIMARY IMMUNE THROMBOCYTOPENIA",TERMINATED,,PHASE1,58.0,ACTUAL,Pfizer,The study was terminated due to sponsor's business decision.,5.0,,The Sponsor has decided to terminate the above referenced clinical study for business reasons. There were no safety concerns that led to this decision and there was no impact to participant safety.,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,INDUSTRY,,,,,,,2023,0.0
NCT01335399,,2011-04-13,2020-09-28,,2022-09-02,2011-04-13,2011-04-14,ESTIMATED,2020-09-28,2020-10-22,ACTUAL,,,,2022-09-02,2022-09-30,ACTUAL,2011-08-04,ACTUAL,2011-08-04,2022-09,2022-09-30,2021-09-03,ACTUAL,2021-09-03,2019-10-01,ACTUAL,2019-10-01,,INTERVENTIONAL,ELOQUENT - 1,All randomized participants,"Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma","A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma",COMPLETED,,PHASE3,748.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,INDUSTRY,,,,,,,2021,1.0
NCT03538041,,2018-05-15,2022-08-01,,2024-04-08,2018-05-15,2018-05-25,ACTUAL,2022-08-26,2022-09-22,ACTUAL,,,,2024-04-08,2024-04-10,ACTUAL,2018-11-21,ACTUAL,2018-11-21,2024-04,2024-04-30,2024-04-02,ACTUAL,2024-04-02,2021-08-05,ACTUAL,2021-08-05,,INTERVENTIONAL,,,A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia,"A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia",COMPLETED,,PHASE2,25.0,ACTUAL,Incyte Corporation,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,INDUSTRY,,,,,,,2024,1.0
NCT03248297,,2017-07-25,2021-11-16,,2022-03-18,2017-08-11,2017-08-14,ACTUAL,2022-03-18,2022-07-18,ACTUAL,,,,2022-03-18,2022-07-18,ACTUAL,2018-01-12,ACTUAL,2018-01-12,2022-03,2022-03-31,2020-10-01,ACTUAL,2020-10-01,2020-05-15,ACTUAL,2020-05-15,,INTERVENTIONAL,,,Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries,Azithromycin With or Without Amoxicillin to Prevent Peripartum Infection and Sepsis in Laboring High-risk Women: 3-Arm RCT,COMPLETED,,PHASE4,756.0,ACTUAL,University of Alabama at Birmingham,,3.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2020,0.0
NCT01850303,,2013-04-29,,,2023-03-10,2013-05-08,2013-05-09,ESTIMATED,,,,,,,2023-03-10,2023-03-14,ACTUAL,2013-05-16,ACTUAL,2013-05-16,2023-03,2023-03-31,2020-01-31,ACTUAL,2020-01-31,2018-08-20,ACTUAL,2018-08-20,,INTERVENTIONAL,MODEL,,Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer,Phase III Study Comparing Maintenance With Pemetrexed or Gemcitabine to a Surveillance in Elderly Patients (70 Years Old and More) With a Advanced Non Small Cell Lung Cancer Controlled by Induction Chemotherapy.,COMPLETED,,PHASE3,632.0,ACTUAL,Intergroupe Francophone de Cancerologie Thoracique,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,OTHER,,,,,,,2020,0.0
NCT03216356,,2016-10-18,,,2023-02-07,2017-07-12,2017-07-13,ACTUAL,,,,,,,2023-02-07,2023-02-08,ACTUAL,2016-09,,2016-09-30,2023-02,2023-02-28,2024-12,ESTIMATED,2024-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD,Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Boston University Charles River Campus,,3.0,,,f,,,,f,,,,,,,,,,,UNDECIDED,,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,OTHER,,,,,,,2024,0.0
NCT04480879,,2020-07-17,,,2021-08-23,2020-07-17,2020-07-21,ACTUAL,,,,,,,2021-08-23,2021-08-24,ACTUAL,2020-07-17,ACTUAL,2020-07-17,2021-08,2021-08-31,2020-09-02,ACTUAL,2020-09-02,2020-09-02,ACTUAL,2020-09-02,,INTERVENTIONAL,,,Evaluation of AZD8154 Concentrations in Blood,"A Randomised, 3 Period, Single Dose, Open-label Crossover Study to Evaluate the Systemic Exposure of AZD8154 While Administered Via Inhalation Using a Nebuliser Formulation and a Monodose Dry Powder Inhaler (DPI) Formulation in Healthy Subjects",TERMINATED,,PHASE1,10.0,ACTUAL,AstraZeneca,,3.0,,Need for evaluation of emerging pre-clinical toxicology findings,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,INDUSTRY,,,,,,,2020,0.0
NCT04331717,,2020-03-31,,,2022-04-29,2020-03-31,2020-04-02,ACTUAL,,,,,,,2022-04-29,2022-05-02,ACTUAL,2020-11-16,ACTUAL,2020-11-16,2022-04,2022-04-30,2023-12,ESTIMATED,2023-12-31,2023-08,ESTIMATED,2023-08-31,,INTERVENTIONAL,BASH-PC,,Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer,BASH-PC: Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,accrual on hold,f,,,,t,t,t,,,,,,,,,,,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,OTHER,,,,,,,2023,0.0
NCT04071041,,2019-07-31,,,2023-01-27,2019-08-26,2019-08-28,ACTUAL,,,,,,,2023-01-27,2023-01-31,ACTUAL,2019-10-31,ACTUAL,2019-10-31,2023-01,2023-01-31,2021-10-31,ACTUAL,2021-10-31,2021-10-31,ACTUAL,2021-10-31,,INTERVENTIONAL,ALBUCAP,,Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia.,"Effect of Albumin Administration on Outcomes in Hypoalbuminemic Patients Hospitalized With Community-acquired Pneumonia (ALBUCAP): a Prospective, Randomized, Phase III Clinical Controlled Trial.",TERMINATED,,PHASE3,39.0,ACTUAL,Hospital Universitari de Bellvitge,,2.0,,Low recruitment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2021,0.0
NCT02675231,,2016-02-03,2020-04-08,,2024-03-18,2016-02-03,2016-02-05,ESTIMATED,2020-05-15,2020-05-26,ACTUAL,,,,2024-03-18,2024-03-19,ACTUAL,2016-05-23,ACTUAL,2016-05-23,2024-03,2024-03-31,2023-11-09,ACTUAL,2023-11-09,2019-04-08,ACTUAL,2019-04-08,,INTERVENTIONAL,monarcHER,All enrolled participants.,"A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer","monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician's Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer",COMPLETED,,PHASE2,237.0,ACTUAL,Eli Lilly and Company,,3.0,,,t,,,,f,,,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and european union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,INDUSTRY,,NCT03763604,AVAILABLE,,,,2023,1.0
NCT03560908,,2018-06-01,,,2020-03-19,2018-06-15,2018-06-18,ACTUAL,,,,,,,2020-03-19,2020-03-23,ACTUAL,2018-07-01,ACTUAL,2018-07-01,2020-03,2020-03-31,2021-12-31,ESTIMATED,2021-12-31,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation,Dasatinib Combined With Multi-agents Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation,WITHDRAWN,,PHASE1,0.0,ACTUAL,"Institute of Hematology & Blood Diseases Hospital, China",,1.0,,No enough eligable participants enrolled,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2021,0.0
NCT04443192,,2020-06-16,,,2022-09-15,2020-06-22,2020-06-23,ACTUAL,,,,,,,2022-09-15,2022-09-19,ACTUAL,2020-08-03,ACTUAL,2020-08-03,2022-09,2022-09-30,2022-09-12,ACTUAL,2022-09-12,2022-09-12,ACTUAL,2022-09-12,,INTERVENTIONAL,,,A Single Ascending and Repeated Dose Study of Oral ZF874 in Healthy Volunteers and PiXZ Subjects,"A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending and Repeated Doses of Orally Administered ZF874 in Healthy Volunteers and PiXZ Subjects",TERMINATED,,PHASE1,69.0,ACTUAL,Z Factor Limited,,14.0,,"Based on the results observed to date, the Sponsor concluded that ZF874 was unlikely to achieve the desired target product profile.",f,,,,t,f,f,,,f,,,,,,NO,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,INDUSTRY,,,,,,,2022,0.0
NCT04621331,,2020-11-03,,,2022-06-29,2020-11-03,2020-11-09,ACTUAL,,,,,,,2022-06-29,2022-07-05,ACTUAL,2022-05-23,ACTUAL,2022-05-23,2022-06,2022-06-30,2022-05-23,ACTUAL,2022-05-23,2022-05-23,ACTUAL,2022-05-23,,INTERVENTIONAL,,,"Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD","An Open-label, Multicenter Study Investigating the Efficacy, Safety and Pharmacokinetics of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease",WITHDRAWN,,PHASE3,0.0,ACTUAL,FibroGen,,1.0,,Sponsor's decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,INDUSTRY,,,,,,,2022,0.0
NCT04609865,,2020-10-23,,,2024-05-28,2020-10-29,2020-10-30,ACTUAL,,,,,,,2024-05-28,2024-05-30,ACTUAL,2020-11-04,ACTUAL,2020-11-04,2024-05,2024-05-31,2022-03-17,ACTUAL,2022-03-17,2022-03-17,ACTUAL,2022-03-17,,INTERVENTIONAL,LidoCovid,,Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia,Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia,TERMINATED,,PHASE3,14.0,ACTUAL,"University Hospital, Strasbourg, France",,2.0,,departure of the principal investigator and inclusion difficulties,f,,,,,f,f,,,,,,,,,,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,OTHER,,,,,,,2022,0.0
NCT03876925,,2019-03-14,,,2021-03-22,2019-03-14,2019-03-15,ACTUAL,,,,,,,2021-03-22,2021-03-24,ACTUAL,2018-06-25,ACTUAL,2018-06-25,2021-03,2021-03-31,2020-05-12,ACTUAL,2020-05-12,2020-03-01,ACTUAL,2020-03-01,,INTERVENTIONAL,,,"A Single Arm, Open-label,Phase Ib Study of CT053PTSA in Preciously Treated Patients With Advanced and Metastatic RCC","A Single Arm, Open-label,Phase Ib Study of CT053PTSA in Preciously Treated Patients With Advanced and Metastatic Renal Cell Cancer",TERMINATED,,PHASE1/PHASE2,10.0,ACTUAL,"Sunshine Lake Pharma Co., Ltd.",,1.0,,The effect of CT053PTSA in preciously treated patients with advanced and metastatic RCC is not as good as pre-expected,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,INDUSTRY,,,,,,,2020,0.0
NCT03956550,,2019-05-16,2021-04-28,,2021-06-10,2019-05-16,2019-05-20,ACTUAL,2021-06-10,2021-07-01,ACTUAL,,,,2021-06-10,2021-07-01,ACTUAL,2019-05-21,ACTUAL,2019-05-21,2021-06,2021-06-30,2020-10-29,ACTUAL,2020-10-29,2020-05-01,ACTUAL,2020-05-01,,INTERVENTIONAL,,,A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee,"A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee",TERMINATED,,PHASE2,259.0,ACTUAL,Regeneron Pharmaceuticals,,3.0,,"Regeneron has discontinued further clinical development of REGN5069, an antibody to GFRα3, which was previously being studied in osteoarthritis pain of the knee",f,,,,t,t,f,,,,,,"Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.","Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, EMA, PMDA, etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).",https://vivli.org/,YES,All IPD that underlie publicly available results will be considered for sharing,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,INDUSTRY,,,,,,,2020,0.0
NCT04322773,,2020-03-24,,,2020-10-08,2020-03-24,2020-03-26,ACTUAL,,,,,,,2020-10-08,2020-10-09,ACTUAL,2020-04-05,ACTUAL,2020-04-05,2020-10,2020-10-31,2020-10-08,ACTUAL,2020-10-08,2020-10-08,ACTUAL,2020-10-08,,INTERVENTIONAL,TOCIVID,,Anti-il6 Treatment of Serious COVID-19 Disease With Threatening Respiratory Failure,"Effectiveness of Interleukin-6 Receptor Inhibitors in the Management of Patients With Severe SARS-CoV-2 Pneumonia: An Open-Label, Multicenter Sequential and Cluster Randomized Trial",TERMINATED,,PHASE2,20.0,ACTUAL,Frederiksberg University Hospital,,4.0,,The study has been terminated due to changed clinical conditions and too few patients available,f,,,,f,f,f,,,f,,,,,,YES,,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,OTHER,,,,,,,2020,0.0
NCT03718507,,2018-10-23,,,2021-07-29,2018-10-23,2018-10-24,ACTUAL,,,,,,,2021-07-29,2021-08-04,ACTUAL,2019-05-20,ESTIMATED,2019-05-20,2021-07,2021-07-31,2020-02-20,ESTIMATED,2020-02-20,2019-12-20,ESTIMATED,2019-12-20,,INTERVENTIONAL,SAFE LISA,,Study on the Effects of Different Premedication for LISA on Stress and Cerebral Tissue Oxygenation in Preterm Infants,"A Single-centre, Randomized Pilot Study on the Effects of Different Premedication Treatments for Less Invasive Surfactant Administration (LISA) on Pain, Cerebral Tissue Oxygenation and Cortisol Levels in Preterm Infants",WITHDRAWN,,PHASE1,0.0,ACTUAL,ASST Fatebenefratelli Sacco,,2.0,,no recrutiment started,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,OTHER,,,,,,,2020,0.0
NCT02601157,,2015-11-07,,,2023-01-08,2015-11-07,2015-11-10,ESTIMATED,,,,,,,2023-01-08,2023-01-10,ACTUAL,2016-01-18,,2016-01-18,2023-01,2023-01-31,2022-08-14,ACTUAL,2022-08-14,2021-08-14,ACTUAL,2021-08-14,,INTERVENTIONAL,HOST-IDEA,,Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - Coronary Intervention With Next Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy (HOST-IDEA) Trial,Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - Coronary Intervention With Next Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy (HOST-IDEA) Trial,COMPLETED,,PHASE4,2173.0,ACTUAL,Seoul National University Hospital,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,OTHER,,,,,,,2022,1.0
NCT04442230,,2020-06-17,2022-02-07,,2022-03-31,2020-06-19,2020-06-22,ACTUAL,2022-03-31,2022-04-04,ACTUAL,,,,2022-03-31,2022-04-04,ACTUAL,2020-10-10,ACTUAL,2020-10-10,2022-02,2022-02-28,2021-02-15,ACTUAL,2021-02-15,2021-02-15,ACTUAL,2021-02-15,,INTERVENTIONAL,,Safety Population,NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19),"Phase 2, Double-blind, Randomized, Placebo-controlled Study of NasoVAX in the Prevention of Clinical Worsening in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)",TERMINATED,,PHASE2,48.0,ACTUAL,"Altimmune, Inc.",,2.0,,Enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,INDUSTRY,,,,,,,2021,0.0
NCT02501278,,2015-07-07,,,2016-05-12,2015-07-15,2015-07-17,ESTIMATED,,,,,,,2016-05-12,2016-05-13,ESTIMATED,2016-05,,2016-05-31,2016-05,2016-05-31,2021-05,ESTIMATED,2021-05-31,2019-05,ESTIMATED,2019-05-31,,INTERVENTIONAL,,,A Phase II Clinical Trial of Chemo-radiotherapy in Combination With INO-3112 in Patients With Locally Advanced Cervical Cancer,A Phase II Clinical Trial of Chemo-radiotherapy in Combination With INO-3112 in Patients With Locally Advanced Cervical Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,European Organisation for Research and Treatment of Cancer - EORTC,,3.0,,company (Inovio) is no longer able to support the study,f,,,,t,,,,,,,,,,,,,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,NETWORK,,,,,,,2021,0.0
NCT03591380,,2018-05-03,2022-11-15,,2022-12-13,2018-07-06,2018-07-19,ACTUAL,2022-12-13,2023-01-09,ACTUAL,,,,2022-12-13,2023-01-09,ACTUAL,2019-05-14,ACTUAL,2019-05-14,2022-12,2022-12-31,2021-12-03,ACTUAL,2021-12-03,2021-12-03,ACTUAL,2021-12-03,,INTERVENTIONAL,CAMPBEL,,CAMPath and BELimumab for Transplant Tolerance in Sensitized Kidney Transplant Recipients,CAMPath and BELimumab for the Induction of Donor Specific Humoral Transplant Tolerance in Sensitized Kidney Transplant Recipients To Improve Long-Term Allograft Survival,TERMINATED,,PHASE2,3.0,ACTUAL,"University of Wisconsin, Madison",,1.0,,Recruitment complications due to COVID-19,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,OTHER,,,,,,,2021,0.0
NCT03651804,,2018-08-14,,,2024-07-05,2018-08-27,2018-08-29,ACTUAL,,,,,,,2024-07-05,2024-07-09,ACTUAL,2019-04-10,ACTUAL,2019-04-10,2024-07,2024-07-31,2023-12-19,ACTUAL,2023-12-19,2023-12-19,ACTUAL,2023-12-19,,INTERVENTIONAL,,,Radiofrequency Ablation: Treatment for Posterior Element Pain From Vertebral Compression Fractures,Radiofrequency Ablation of the Medial Branch Nerve as a Novel Treatment for Posterior Element Pain From Vertebral Compression Fractures,TERMINATED,,PHASE4,5.0,ACTUAL,"University of California, Davis",,3.0,,Difficulty recruiting members,f,,,,,t,f,,,f,,,,,,UNDECIDED,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2023,0.0
NCT04002011,,2019-06-10,,,2023-03-09,2019-06-26,2019-06-28,ACTUAL,,,,,,,2023-03-09,2023-03-13,ACTUAL,2022-03-09,ESTIMATED,2022-03-09,2023-03,2023-03-31,2023-03-09,ACTUAL,2023-03-09,2023-01-01,ESTIMATED,2023-01-01,,INTERVENTIONAL,DOAC/VKA,,DOAC Versus VKA After Cardiac Surgery,Oral Anticoagulation After Cardiac Surgery in the Era of Direct Oral Anticoagulants: is Large Use of Vitamin K Antagonists Still Justified?,WITHDRAWN,,PHASE2,0.0,ACTUAL,Laval University,,2.0,,Submission process abandoned. No patient enrolled.,f,,,,f,f,f,,,f,,,,,,,,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,OTHER,,,,,,,2023,0.0
NCT04338958,,2020-04-07,,,2021-08-12,2020-04-07,2020-04-08,ACTUAL,,,,,,,2021-08-12,2021-08-13,ACTUAL,2020-04-22,ACTUAL,2020-04-22,2021-08,2021-08-31,2021-07-15,ACTUAL,2021-07-15,2021-07-15,ACTUAL,2021-07-15,,INTERVENTIONAL,RuxCoFlam,,Ruxolitinib in Covid-19 Patients With Defined Hyperinflammation,A Phase-II Clinical Trial for First Line Treatment of Stage II/III Covid-19 Patients to Treat Hyperinflammation,COMPLETED,,PHASE2,193.0,ACTUAL,University of Jena,,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,OTHER,,,,,,,2021,1.0
NCT02264990,,2014-10-09,2021-02-08,2020-10-26,2021-02-08,2014-10-09,2014-10-15,ESTIMATED,2021-02-08,2021-02-26,ACTUAL,2020-10-26,2020-10-29,ACTUAL,2021-02-08,2021-02-26,ACTUAL,2014-09-30,ACTUAL,2014-09-30,2021-02,2021-02-28,2020-02-21,ACTUAL,2020-02-21,2019-11-14,ACTUAL,2019-11-14,,INTERVENTIONAL,,The intention-to-treat (ITT) population included all randomized participants.,Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers,"A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers",COMPLETED,,PHASE3,595.0,ACTUAL,AbbVie,,2.0,,,f,,,,f,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,INDUSTRY,,,,,,,2020,1.0
NCT02823028,,2016-06-16,,,2023-05-08,2016-06-30,2016-07-06,ESTIMATED,,,,,,,2023-05-08,2023-05-10,ACTUAL,2016-10,ACTUAL,2016-10-31,2023-05,2023-05-31,2022-09,ACTUAL,2022-09-30,2022-09,ACTUAL,2022-09-30,,INTERVENTIONAL,Tweet2Quit,,Twitter-enabled Mobile Messaging for Smoking Relapse Prevention (Tweet2Quit),Social Media Technology for Treating Tobacco Addiction,COMPLETED,,PHASE2,960.0,ACTUAL,"University of California, Irvine",,3.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,OTHER,,,,,,,2022,1.0
NCT03251417,,2017-08-14,,,2023-01-30,2017-08-15,2017-08-16,ACTUAL,,,,,,,2023-01-30,2023-02-01,ACTUAL,2017-09-10,ACTUAL,2017-09-10,2023-01,2023-01-31,2021-04-25,ACTUAL,2021-04-25,2021-04-25,ACTUAL,2021-04-25,,INTERVENTIONAL,,,Apatinib and Irinotecan Combination Treatment in Unresectable or Metastatic Esophageal Squamous Cell Carcinoma,Apatinib and Irinotecan Combination Treatment in Unresectable or Metastatic Esophageal Squamous Cell Carcinoma Patients Failed in First-line Chemotherapy: A Phase II Study,TERMINATED,,PHASE2,11.0,ACTUAL,Peking University,,1.0,,"Because PD-1 antibodies had been proved to be a standard second-line treatment in esophageal cancer, the potential benefit of present intervention is under re-evaluation.",f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2021,0.0
NCT03504410,,2018-04-12,2022-10-25,,2023-01-12,2018-04-19,2018-04-20,ACTUAL,2022-11-16,2022-12-13,ACTUAL,,,,2023-01-12,2023-02-08,ACTUAL,2018-11-12,ACTUAL,2018-11-12,2023-01,2023-01-31,2022-01-19,ACTUAL,2022-01-19,2021-10-25,ACTUAL,2021-10-25,,INTERVENTIONAL,,"All subjects randomized were included in the analysis. Post interim analysis, the study was discontinued and no additional data was collected and analyzed.",Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML,Phase 3 Multicenter Randomized Trial to Evaluate Efficacy and Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. Therapy and Control Sub-groups in Older Patients With R/R AML,TERMINATED,,PHASE3,200.0,ACTUAL,Cornerstone Pharmaceuticals,,2.0,,Futile,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,INDUSTRY,,,,,,,2022,0.0
NCT03824808,,2018-11-13,2023-07-10,,2023-10-23,2019-01-30,2019-01-31,ACTUAL,2023-10-23,2023-10-25,ACTUAL,,,,2023-10-23,2023-10-25,ACTUAL,2019-02-26,ACTUAL,2019-02-26,2023-10,2023-10-31,2020-03-26,ACTUAL,2020-03-26,2020-03-26,ACTUAL,2020-03-26,,INTERVENTIONAL,,"11 patients were randomized into the treatment group, while 10 patients were randomized to the control group. Investigators were blinded to the randomization.",Effect of Perioperative Intravenous Lidocaine Infusion in Robotic-Assisted Urologic Surgery,"A Prospective, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial Evaluating the Use of Perioperative Intravenous Lidocaine Infusion to Decrease Pain Scores and Opioid Consumption After Robotic-Assisted Prostatectomy and Robotic-Assisted Partial Nephrectomy",TERMINATED,,PHASE4,21.0,ACTUAL,University of Missouri-Columbia,,2.0,,Challenges with recruitment of surgical research subjects in the target population.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,OTHER,,,,,,,2020,0.0
NCT03805841,,2019-01-11,2023-03-28,,2023-06-27,2019-01-14,2019-01-16,ACTUAL,2023-06-27,2023-06-28,ACTUAL,,,,2023-06-27,2023-06-28,ACTUAL,2019-03-13,ACTUAL,2019-03-13,2023-04,2023-04-30,2021-04-23,ACTUAL,2021-04-23,2021-04-09,ACTUAL,2021-04-09,,INTERVENTIONAL,RAIN,,"Study of Tarloxotinib in Pts With NSCLC (EGFR Exon 20 Insertion, HER2-activating Mutations) & Other Solid Tumors With NRG1/ERBB Gene Fusions",Phase 2 Study - Evaluate the Clinical Activity of Tarloxotinib in Patients With Non-Small Cell Lung Cancer That Harbors an EGFR Exon 20 Insertion or HER2-Activating Mutation and Other Advanced Solid Tumors With NRG1/ERBB Family Gene Fusions,TERMINATED,,PHASE2,41.0,ACTUAL,Rain Oncology Inc,,1.0,,enrollment pause,f,,,,f,t,f,,,,,,,,,NO,No Plan,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,INDUSTRY,,,,,,,2021,0.0
NCT04899232,,2021-05-20,2022-07-15,,2022-08-16,2021-05-20,2021-05-24,ACTUAL,2022-08-16,2022-09-07,ACTUAL,,,,2022-08-16,2022-09-07,ACTUAL,2021-07-06,ACTUAL,2021-07-06,2022-08,2022-08-31,2022-03-31,ACTUAL,2022-03-31,2022-03-31,ACTUAL,2022-03-31,,INTERVENTIONAL,,,Antithrombin III in Infectious Disease Caused by COVID-19,Antithrombin III (AT3) in Infectious Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)/ Coronavirus Disease of 2019 (COVID-19),TERMINATED,,PHASE2,52.0,ACTUAL,University of Miami,"With decreased Coronavirus disease of 2019 (COVID-19) cases, enrollment slowed leading to the early termination of the trial; the target number of 75 enrolled patients was not reached. Hesitancy to participate in the trial was noted.",3.0,,There are fewer potential patients and an early conclusion of the study would be beneficial in an attempt to finish in a reasonable time and keep the cohorts homogenous.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,OTHER,,,,,,,2022,0.0
NCT05028751,,2021-08-25,2024-07-11,,2024-07-11,2021-08-25,2021-08-31,ACTUAL,2024-07-11,2024-08-07,ACTUAL,,,,2024-07-11,2024-08-07,ACTUAL,2022-08-05,ACTUAL,2022-08-05,2024-07,2024-07-31,2024-04-09,ACTUAL,2024-04-09,2024-04-09,ACTUAL,2024-04-09,,INTERVENTIONAL,,Safety Population: Consisted of all participants who received ≥ 1 dose of either study drug and had at least 1 on-treatment safety-related observation.,A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML),"A Phase 1b/2 Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of the Selective SYK Inhibitor Lanraplenib (LANRA) in Combination With the FLT3 Inhibitor Gilteritinib, in Patients With FLT3-mutated Relapsed or Refractory AML",TERMINATED,,PHASE1/PHASE2,24.0,ACTUAL,Kronos Bio,"In light of the Sponsor's decision to terminate the trial at completion of Phase 1b, all analyses were restricted to results from Phase 1b participants only. Phase 2 was not enrolled.",4.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,INDUSTRY,,,,,,,2024,0.0
NCT00288080,,2006-02-06,2016-11-28,,2022-05-23,2006-02-06,2006-02-07,ESTIMATED,2016-11-28,2017-01-23,ESTIMATED,,,,2022-05-23,2022-06-21,ACTUAL,2005-12,,2005-12-31,2022-05,2022-05-31,2022-05-20,ACTUAL,2022-05-20,2014-04,ACTUAL,2014-04-30,,INTERVENTIONAL,,Eligible patients who have not withdrawn consent.,Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer,"A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer",COMPLETED,,PHASE3,612.0,ACTUAL,Radiation Therapy Oncology Group,"Due to insufficient number of events, local control analysis was not conducted.",2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,NETWORK,,,,,,,2022,1.0
NCT04315181,,2020-03-17,2024-05-03,,2024-06-25,2020-03-17,2020-03-19,ACTUAL,2024-06-25,2024-06-27,ACTUAL,,,,2024-06-25,2024-06-27,ACTUAL,2019-03-25,ACTUAL,2019-03-25,2024-06,2024-06-30,2023-05-06,ACTUAL,2023-05-06,2023-05-06,ACTUAL,2023-05-06,,INTERVENTIONAL,,One participant did not complete the study. They were non-responsive to the drug conditions and was discharged.,Prescription Medication Interactions,Prescription Medications: Pharmacodynamics and Interaction Effects,COMPLETED,,PHASE1,11.0,ACTUAL,University of Kentucky,,9.0,,,f,,,,,t,f,,,,,,,,,NO,We have no plans to share individual participant data with other researchers.,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,OTHER,,,,,,,2023,1.0
NCT03219866,,2017-07-12,2021-04-05,,2021-06-10,2017-07-13,2017-07-18,ACTUAL,2021-05-14,2021-06-10,ACTUAL,,,,2021-06-10,2021-06-22,ACTUAL,2017-10-03,ACTUAL,2017-10-03,2020-09,2020-09-30,2020-04-01,ACTUAL,2020-04-01,2020-04-01,ACTUAL,2020-04-01,,INTERVENTIONAL,,,Nebulizer Versus Dry Powdered Inhalers for Chronic Obstructive Pulmonary Disease (COPD),Preliminary Study for Comparison of Triple Therapy Nebulizer Versus Dry Powdered Inhaler for Care Transitions in COPD,TERMINATED,,PHASE4,40.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,Lower enrollment than Sponsor expected - Sponsor stopped study,f,,,,f,t,t,,,f,,,,,,NO,,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,OTHER,,,,,,,2020,0.0
NCT02292238,,2014-11-10,2022-03-08,,2022-06-02,2014-11-14,2014-11-17,ESTIMATED,2022-06-02,2022-06-28,ACTUAL,,,,2022-06-02,2022-06-28,ACTUAL,2015-02-15,ACTUAL,2015-02-15,2022-06,2022-06-30,2020-09-08,ACTUAL,2020-09-08,2020-07-20,ACTUAL,2020-07-20,,INTERVENTIONAL,Benfotiamine,1 subject on the placebo arm was excluded from analysis due to taking benfotiamine from a commercial vendor.,Benfotiamine in Alzheimer's Disease: A Pilot Study,Benfotiamine in Alzheimer's Disease: A Pilot Study,COMPLETED,,PHASE2,71.0,ACTUAL,Burke Medical Research Institute,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,OTHER,,,,,,,2020,1.0
NCT04040686,,2019-07-30,,,2023-04-13,2019-07-31,2019-08-01,ACTUAL,,,,,,,2023-04-13,2023-04-14,ACTUAL,2019-07-29,ACTUAL,2019-07-29,2023-04,2023-04-30,2022-03-30,ACTUAL,2022-03-30,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,HER2 Expression Detection in Breast Cancer Using 99mTc-NM-02,Technetium-99m Labeled Anti-HER2 sdAb (99m-Tc-NM-02) for HER2 Expression Detection in Breast Cancer,COMPLETED,,EARLY_PHASE1,10.0,ACTUAL,"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",,1.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2022,1.0
NCT02734615,,2016-03-23,,,2022-07-28,2016-04-06,2016-04-12,ESTIMATED,,,,,,,2022-07-28,2022-08-01,ACTUAL,2016-06-14,ACTUAL,2016-06-14,2022-07,2022-07-31,2021-09-13,ACTUAL,2021-09-13,2021-09-13,ACTUAL,2021-09-13,,INTERVENTIONAL,,,Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers,"A Phase I/Ib, Open Label Study of LSZ102 Single Agent and LSZ102 in Combination With Either LEE011 (LSZ102 + LEE011) or BYL719 (LSZ102 + BYL719) in Patients With Advanced or Metastatic ER+ Breast Cancer Who Have Progressed After Endocrine Therapy",TERMINATED,,PHASE1,199.0,ACTUAL,Novartis,,7.0,,Sponsor's decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,INDUSTRY,,,,,,,2021,0.0
NCT03477162,,2018-03-14,2022-11-30,,2022-11-30,2018-03-23,2018-03-26,ACTUAL,2022-11-30,2023-10-03,ACTUAL,,,,2022-11-30,2023-10-03,ACTUAL,2018-05-15,ACTUAL,2018-05-15,2022-11,2022-11-30,2021-11-30,ACTUAL,2021-11-30,2021-11-30,ACTUAL,2021-11-30,,INTERVENTIONAL,,,Metformin Pharmacology in Human Cancers: A Proof of Principle Study,Metformin Pharmacology in Human Cancers,TERMINATED,,EARLY_PHASE1,18.0,ACTUAL,Dartmouth-Hitchcock Medical Center,,1.0,,"Enrollment was closed as efforts had become more challenging, and the lab indicated that they were able to obtain their primary objective with the number that had already been enrolled.",f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2021,0.0
NCT04004221,,2019-06-28,2022-03-01,,2022-06-07,2019-06-28,2019-07-01,ACTUAL,2022-06-07,2023-03-16,ACTUAL,,,,2022-06-07,2023-03-16,ACTUAL,2017-06-16,ACTUAL,2017-06-16,2022-06,2022-06-30,2021-03-11,ACTUAL,2021-03-11,2019-09-16,ACTUAL,2019-09-16,,INTERVENTIONAL,,Safety Analysis Set includes all participants who received any dose of Tislelizumab,Study of Tislelizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer,"A Single-Arm, Multicenter Phase 2 Study of BGB-A317 in Patients With Previously Treated PD-L1+ Locally Advanced or Metastatic Urothelial Bladder Cancer",COMPLETED,,PHASE2,113.0,ACTUAL,BeiGene,,1.0,,,f,,,,t,f,f,,,f,,,,,,YES,"Upon request, and subject to certain criteria, conditions, and exceptions, BeiGene will provide access to individual de-identified participant data from BeiGene-sponsored global interventional clinical studies conducted for medicines for indications that have been approved or in programmes that have been terminated. BeiGene will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data requests can be submitted to medicalinformation@beigene.com.",2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,INDUSTRY,,,,,,,2021,1.0
NCT02765165,,2016-04-19,2021-05-05,,2021-07-01,2016-05-04,2016-05-06,ESTIMATED,2021-07-01,2021-07-23,ACTUAL,,,,2021-07-01,2021-07-23,ACTUAL,2016-04,ACTUAL,2016-04-30,2021-07,2021-07-31,2020-07-01,ACTUAL,2020-07-01,2020-07-01,ACTUAL,2020-07-01,,INTERVENTIONAL,,,Phase 1/2 Study of USL311 +/- Lomustine in Advanced Solid Tumors or Relapsed/Recurrent Glioblastoma Multiforme (GBM),"A Phase 1/2 Dose-escalation of USL311 as Single Agent and in Combination With Lomustine (CCNU) in Subjects With Advanced Solid Tumors, With Subsequent Single Agent and Combination Phase 2 Cohorts for Subjects With Relapsed/Recurrent Glioblastoma Multiforme (GBM)",TERMINATED,,PHASE1/PHASE2,26.0,ACTUAL,"Proximagen, LLC",Small cohort sample size. Heterogenous solid tumor types.,5.0,,Business reasons not related to safety,f,,,,f,t,f,,,,,,,,,,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,INDUSTRY,,,,,,,2020,0.0
NCT03451773,,2018-03-01,2021-03-07,,2021-05-27,2018-03-01,2018-03-02,ACTUAL,2021-05-27,2021-06-16,ACTUAL,,,,2021-05-27,2021-06-16,ACTUAL,2018-05-17,ACTUAL,2018-05-17,2021-05,2021-05-31,2020-05-05,ACTUAL,2020-05-05,2020-05-05,ACTUAL,2020-05-05,,INTERVENTIONAL,,,M7824 (MSB0011359C) in Combination With Gemcitabine in Adults With Previously Treated Advanced Adenocarcinoma of the Pancreas,A Phase IB/II Single-arm Study of M7824 (MSB0011359C) in Combination With Gemcitabine in Adults With Previously Treated Advanced Adenocarcinoma of the Pancreas,TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,Study was closed after one treatment related death.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 03:45:25.816113,2024-10-16 03:45:25.816113,NIH,,,,,,,2020,0.0
NCT03757910,,2018-11-27,,,2024-03-01,2018-11-27,2018-11-29,ACTUAL,,,,,,,2024-03-01,2024-03-04,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2024-03,2024-03-31,2023-01-31,ACTUAL,2023-01-31,2023-01-31,ACTUAL,2023-01-31,,INTERVENTIONAL,DPPOS-Brain,,Brain Imaging in the Diabetes Prevention Program Outcomes Study,Amyloid Brain Positron Emission Tomography (PET) Imaging With 11C-PIB and Tau PET Imaging With 18F-MK-6240 in the Diabetes Prevention Program Outcomes Study.,TERMINATED,,EARLY_PHASE1,5.0,ACTUAL,Columbia University,,2.0,,Difficulty recruiting due to the COVID-19 pandemic and end of funding,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,OTHER,,,,,,,2023,0.0
NCT00676715,,2008-05-09,2017-03-31,2013-03-25,2024-02-17,2008-05-09,2008-05-13,ESTIMATED,2017-03-31,2017-05-11,ACTUAL,2013-03-25,2013-04-01,ESTIMATED,2024-02-17,2024-02-22,ACTUAL,2008-07-17,ACTUAL,2008-07-17,2024-02,2024-02-29,2023-11-08,ACTUAL,2023-11-08,2012-03-09,ACTUAL,2012-03-09,,INTERVENTIONAL,,The safety population included all participants who received any study drug and underwent at least one assessment of safety.,A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis,"Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS",COMPLETED,,PHASE2,220.0,ACTUAL,"Genentech, Inc.",,4.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,INDUSTRY,,,,,,,2023,1.0
NCT03891173,,2019-03-18,,,2022-08-09,2019-03-25,2019-03-26,ACTUAL,,,,,,,2022-08-09,2022-08-12,ACTUAL,2019-02-19,ACTUAL,2019-02-19,2022-08,2022-08-31,2020-05-22,ACTUAL,2020-05-22,2020-05-22,ACTUAL,2020-05-22,,INTERVENTIONAL,,,A Study of L-DOS47 in Combination With Vinorelbine/Cisplatin in Lung Adenocarcinoma,"A Phase II, Open-Label, Randomized Study Immunoconjugate L-DOS47 in Combination With Vinorelbine/Cisplatin Versus Vinorelbine/Cisplatin Alone in Patients With Lung Adenocarcinoma",TERMINATED,,PHASE2,9.0,ACTUAL,Helix BioPharma Corporation,,2.0,,Study was halted at this time due to other budgetary priorities. Completion of reporting has been delayed first due to covid restrictions and more recently due to war in Ukraine.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,INDUSTRY,,,,,,,2020,0.0
NCT04660643,,2020-12-01,2024-04-25,,2024-05-21,2020-12-08,2020-12-09,ACTUAL,2024-05-21,2024-05-22,ACTUAL,,,,2024-05-21,2024-05-22,ACTUAL,2021-03-29,ACTUAL,2021-03-29,2024-05,2024-05-31,2023-05-18,ACTUAL,2023-05-18,2023-04-25,ACTUAL,2023-04-25,,INTERVENTIONAL,SURMOUNT-4,All randomized participants.,A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss,"Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for Maintenance of Weight Loss in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-4)",COMPLETED,,PHASE3,783.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,INDUSTRY,,,,,,,2023,1.0
NCT04673786,,2020-12-13,2023-05-03,,2023-06-01,2020-12-13,2020-12-17,ACTUAL,2023-06-01,2023-06-05,ACTUAL,,,,2023-06-01,2023-06-05,ACTUAL,2021-01-11,ACTUAL,2021-01-11,2023-06,2023-06-30,2022-05-12,ACTUAL,2022-05-12,2021-08-04,ACTUAL,2021-08-04,,INTERVENTIONAL,,,A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis,"A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Moderate to Severe Plaque Psoriasis",COMPLETED,,PHASE3,509.0,ACTUAL,Celltrion,"Due to the conflict in Ukraine, sponsor provided guideline for exceptional allowance regarding visit window and study assessments (only EOS visit was affected) in order to ensure patients' safety and the robustness and integrity of data.",2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,INDUSTRY,,,,,,,2022,1.0
NCT05532046,,2022-09-05,,,2024-03-08,2022-09-05,2022-09-08,ACTUAL,,,,,,,2024-03-08,2024-03-12,ACTUAL,2022-09-20,ACTUAL,2022-09-20,2024-03,2024-03-31,2023-03-31,ACTUAL,2023-03-31,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,REMOTE-HF,,"A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT)","A Phase 1b Double-blind, Randomized, Placebo-controlled, Multicenter, Dose Titration Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 4 Weeks Treatment With BAY 2413555 in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices",TERMINATED,,PHASE1,22.0,ACTUAL,Bayer,,3.0,,Due to new preclinical findings in a chronic toxicology study.,,,,,t,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,INDUSTRY,,,,,,,2023,0.0
NCT03212716,,2017-07-04,,,2023-02-02,2017-07-06,2017-07-11,ACTUAL,,,,,,,2023-02-02,2023-02-06,ACTUAL,2017-12-23,ACTUAL,2017-12-23,2023-01,2023-01-31,2022-05-04,ACTUAL,2022-05-04,2022-05-04,ACTUAL,2022-05-04,,INTERVENTIONAL,FLUNEXT,,Efficiency of Antagonist Drugs of the Cellular Transcriptomic Signature of Influenza A Virus Infection.,"Validation of the Efficiency of Molecules Reproposed on the Basis of Their Cellular Transcriptomic Signature, Antagonist of the Signature Determined in Infection Due to Virus Influenza A.",TERMINATED,,PHASE2,85.0,ACTUAL,"University Hospital, Lille",,2.0,,rate of inclusion and study affected by covid-19 epidemic,f,,,,f,f,f,,,,,,,,,,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2022,0.0
NCT00326898,,2006-05-16,2016-10-18,,2022-01-13,2006-05-16,2006-05-17,ESTIMATED,2016-10-18,2016-12-12,ESTIMATED,,,,2022-01-13,2022-02-08,ACTUAL,2006-04-24,ACTUAL,2006-04-24,2022-01,2022-01-31,2021-09-01,ACTUAL,2021-09-01,2015-08-27,ACTUAL,2015-08-27,,INTERVENTIONAL,ASSURE,All randomized patients,Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery,ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma,COMPLETED,,PHASE3,1943.0,ACTUAL,National Cancer Institute (NCI),,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,NIH,,,,,,,2021,1.0
NCT01389024,,2011-06-30,2022-08-01,,2024-06-27,2011-07-06,2011-07-07,ESTIMATED,2022-12-05,2022-12-28,ACTUAL,,,,2024-06-27,2024-07-10,ACTUAL,2012-08-16,ACTUAL,2012-08-16,2024-06,2024-06-30,2022-05-24,ACTUAL,2022-05-24,2022-05-24,ACTUAL,2022-05-24,,INTERVENTIONAL,HUPrevent,Baseline characteristics data was not collected for non-randomized subjects.,Hydroxyurea to Prevent Brain Injury in Sickle Cell Disease,Hydroxyurea to Prevent Central Nervous System (CNS) Complications of Sickle Cell Disease in Children,COMPLETED,,PHASE2,28.0,ACTUAL,Johns Hopkins University,Interpretation is limited by small sample size.,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,OTHER,,,,,,,2022,1.0
NCT03759665,,2018-11-27,2023-12-07,,2024-02-12,2018-11-28,2018-11-30,ACTUAL,2024-02-12,2024-03-12,ACTUAL,,,,2024-02-12,2024-03-12,ACTUAL,2019-06-07,ACTUAL,2019-06-07,2024-02,2024-02-29,2023-01-09,ACTUAL,2023-01-09,2023-01-09,ACTUAL,2023-01-09,,INTERVENTIONAL,,,N-Acetyl-L-Leucine for GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease),"Effects of N-Acetyl-L-Leucine on GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease): A Multinational, Multicenter, Open-label, Rater-blinded Phase II Study",COMPLETED,,PHASE2,30.0,ACTUAL,IntraBio Inc,"This study was ongoing during the COVID-19 pandemic, and the conduct of this study was impacted by the COVID-19 pandemic.",2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,INDUSTRY,,,,,,,2023,1.0
NCT05119712,,2021-11-03,,,2023-08-24,2021-11-03,2021-11-15,ACTUAL,,,,,,,2023-08-24,2023-08-28,ACTUAL,2021-03-09,ACTUAL,2021-03-09,2023-08,2023-08-31,2024-10-15,ESTIMATED,2024-10-15,2023-10-15,ESTIMATED,2023-10-15,,INTERVENTIONAL,FUN,,Terbinafine Treatment of Axial Spondyloarthropathy,Terbinafine Treatment of Axial Spondyloarthropathy,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Oregon Health and Science University,,2.0,,Study stopped due to poor recruitment.,f,,,,f,t,f,,,,,,,,,NO,There is no plan to share IPD with other researchers.,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,OTHER,,,,,,,2024,0.0
NCT03585270,,2018-06-29,2023-11-14,2023-02-07,2023-12-18,2018-06-29,2018-07-12,ACTUAL,2023-12-18,2024-01-10,ACTUAL,,2024-01-10,ACTUAL,2023-12-18,2024-01-10,ACTUAL,2019-02-03,ACTUAL,2019-02-03,2023-12,2023-12-31,2022-11-18,ACTUAL,2022-11-18,2022-06-13,ACTUAL,2022-06-13,,INTERVENTIONAL,REACT,Full Analysis Set,"Clinical Research Study With Clazosentan to Evaluate Its Effects on Preventing Complications Due to the Narrowing of the Blood Vessels (Vasospasm) in the Brain, Caused by Bleeding Onto the Surface of the Brain","A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Assess the Efficacy and Safety of Clazosentan in Preventing Clinical Deterioration Due to Delayed Cerebral Ischemia (DCI), in Adult Subjects With Aneurysmal Subarachnoid Hemorrhage (aSAH)",COMPLETED,,PHASE3,409.0,ACTUAL,Idorsia Pharmaceuticals Ltd.,,2.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,INDUSTRY,,,,,,,2022,1.0
NCT02460874,,2015-05-28,2022-05-19,,2022-08-24,2015-05-29,2015-06-03,ESTIMATED,2022-08-24,2022-09-21,ACTUAL,,,,2022-08-24,2022-09-21,ACTUAL,2017-08-16,ACTUAL,2017-08-16,2022-08,2022-08-31,2021-05-19,ACTUAL,2021-05-19,2021-05-19,ACTUAL,2021-05-19,,INTERVENTIONAL,,terminated early,Glyburide vs Placebo as Prophylaxis Against Cerebral Edema in Patients Receiving Radiosurgery for Brain Metastases (RAD 1502/UAB 1593),A Pilot Study and Phase II Double Blind Placebo Controlled Randomized Trial Examining the Safety and Efficacy of Glyburide as Prophylaxis Against Cerebral Edema in Patients Receiving Radiosurgery for Brain Metastases,TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,University of Alabama at Birmingham,,2.0,,Slow accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,OTHER,,,,,,,2021,0.0
NCT03894618,,2019-01-10,,,2024-06-10,2019-03-27,2019-03-28,ACTUAL,,,,,,,2024-06-10,2024-06-12,ACTUAL,2019-03-26,ACTUAL,2019-03-26,2024-06,2024-06-30,2023-05-04,ACTUAL,2023-05-04,2023-05-04,ACTUAL,2023-05-04,,INTERVENTIONAL,,,SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas,"Phase 1 Dose Escalation and Dose Expansion Study of an Agonist Redirected Checkpoint Fusion Protein, SL-279252 (PD1-Fc-OX40L), in Subjects With Advanced Solid Tumors or Lymphomas",COMPLETED,,PHASE1,49.0,ACTUAL,"Shattuck Labs, Inc.",,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,INDUSTRY,,,,,,,2023,1.0
NCT04317040,,2020-03-19,2021-09-28,,2023-01-11,2020-03-19,2020-03-20,ACTUAL,2021-10-13,2021-10-15,ACTUAL,,,,2023-01-11,2023-02-08,ACTUAL,2020-04-24,ACTUAL,2020-04-24,2023-01,2023-01-31,2020-10-20,ACTUAL,2020-10-20,2020-10-20,ACTUAL,2020-10-20,,INTERVENTIONAL,SAC-COVID,All randomized participants.,"Efprezimod Alfa (CD24Fc, MK-7110) as a Non-antiviral Immunomodulator in COVID-19 Treatment (MK-7110-007)","A Randomized, Double-blind, Placebo-controlled, Multi-site, Phase III Study to Evaluate the Safety and Efficacy of CD24Fc in COVID-19 Treatment",COMPLETED,,PHASE3,234.0,ACTUAL,"Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)",,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 02:36:26.245542,2024-10-15 02:36:26.245542,INDUSTRY,,,,,,,2020,1.0
NCT02026297,,2013-12-22,2020-08-27,,2020-10-02,2013-12-31,2014-01-01,ESTIMATED,2020-10-02,2020-10-27,ACTUAL,,,,2020-10-02,2020-10-27,ACTUAL,2014-07,ACTUAL,2014-07-31,2020-10,2020-10-31,2020-02-21,ACTUAL,2020-02-21,2015-07,ACTUAL,2015-07-31,,INTERVENTIONAL,TA TEG,Patients scheduled for elective cesarean delivery with low risk for postpartum hemorrhage.,Tranexamic Acid and Thromboelastography During Cesarean Delivery,"The Influence of Prophylactic Tranexamic Acid on Thromboelastography During Cesarean Delivery: A Randomized, Double-Blind, Placebo-Controlled Trial",TERMINATED,,PHASE2,60.0,ACTUAL,Brigham and Women's Hospital,,2.0,,"funding and manpower unavailable, completion within a reasonable timeframe not possible.",f,,,,t,,,,,,,,,,,,,2024-10-17 01:53:53.980063,2024-10-17 01:53:53.980063,OTHER,,,,,,,2020,0.0
NCT04372927,,2020-04-29,2023-01-18,,2023-05-18,2020-04-29,2020-05-04,ACTUAL,2023-05-18,2023-06-13,ACTUAL,,,,2023-05-18,2023-06-13,ACTUAL,2021-12-10,ACTUAL,2021-12-10,2023-05,2023-05-31,2022-04-23,ACTUAL,2022-04-23,2022-04-23,ACTUAL,2022-04-23,,INTERVENTIONAL,,,ADMIRAL Trial: Adaptive Mediastinal Radiation With Chemo-Immunotherapy,Adaptive-Dose to Mediastinum With Immunotherapy (Durvalumab MEDI4736) and Radiation in Locally-Advanced Non-Small Cell Lung Cancer,TERMINATED,,PHASE2,1.0,ACTUAL,University of Washington,"We enrolled one participant, then trial closed due to poor accrual. Early termination leading to small numbers of subjects analyzed.",1.0,,Terminated due to slow accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,OTHER,,,,,,,2022,0.0
NCT03605680,,2018-06-28,2021-04-09,,2022-02-22,2018-07-26,2018-07-30,ACTUAL,2021-04-09,2021-05-05,ACTUAL,,,,2022-02-22,2022-03-15,ACTUAL,2019-01-16,ACTUAL,2019-01-16,2022-02,2022-02-28,2020-04-11,ACTUAL,2020-04-11,2020-04-11,ACTUAL,2020-04-11,,INTERVENTIONAL,,Participants who participated only in the Run-in Period and Full Analysis Set (FAS) including all participants in the safety sample who had a Baseline value and at least one valid post-randomization efficacy evaluation for adult ADHD investigator symptom rating scale (AISRS) total score in the Double-blind Treatment Period.,"A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder","A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder",COMPLETED,,PHASE3,604.0,ACTUAL,"Otsuka Pharmaceutical Development & Commercialization, Inc.",,4.0,,,f,,,,f,t,f,,,,,,"Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.",Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/,https://clinical-trials.otsuka.com,YES,Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,INDUSTRY,,,,,,,2020,1.0
NCT04582409,,2020-10-07,2023-07-07,,2024-06-17,2020-10-07,2020-10-09,ACTUAL,2023-07-07,2023-07-25,ACTUAL,,,,2024-06-17,2024-06-20,ACTUAL,2020-11-30,ACTUAL,2020-11-30,2024-06,2024-06-30,2022-07-11,ACTUAL,2022-07-11,2022-07-11,ACTUAL,2022-07-11,,INTERVENTIONAL,,,"A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation","A Randomized, Placebo-controlled, Investigator- and Participant-blinded Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation",TERMINATED,,PHASE2,13.0,ACTUAL,Novartis,,2.0,,Terminated due to business decision,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,INDUSTRY,,,,,,,2022,0.0
NCT03980223,,2019-06-06,2024-05-01,,2024-06-18,2019-06-06,2019-06-10,ACTUAL,2024-06-18,2024-07-12,ACTUAL,,,,2024-06-18,2024-07-12,ACTUAL,2019-11-26,ACTUAL,2019-11-26,2024-06,2024-06-30,2023-06-12,ACTUAL,2023-06-12,2023-06-12,ACTUAL,2023-06-12,,INTERVENTIONAL,,Overall number of baseline participants does not include participants who had not yet reached their month 3 visit at the time of the analysis and those who were lost to FU after month 3.,Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men,Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men,COMPLETED,,PHASE4,641.0,ACTUAL,"University of California, San Francisco",,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,IPD will not be shared with other researchers outside of the study team,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,OTHER,,,,,,,2023,1.0
NCT02949752,,2016-10-04,,,2021-07-19,2016-10-28,2016-10-31,ESTIMATED,,,,,,,2021-07-19,2021-07-21,ACTUAL,2016-08,ACTUAL,2016-08-31,2021-07,2021-07-31,2020-01-01,ACTUAL,2020-01-01,2019-10-01,ACTUAL,2019-10-01,,INTERVENTIONAL,,,Aripiprazole as an Adjunct to Atypical Antipsychotics for Weight Reduction and Improvement in Metabolic Profile,Aripiprazole as an Adjunct to Atypical Antipsychotics for Weight Reduction and Improvement in Metabolic Profile,COMPLETED,,PHASE4,67.0,ACTUAL,"Institute of Mental Health, Singapore",,1.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,OTHER,,,,,,,2020,1.0
NCT04887831,,2021-05-05,,,2024-03-21,2021-05-13,2021-05-14,ACTUAL,,,,,,,2024-03-21,2024-03-22,ACTUAL,2021-06-04,ACTUAL,2021-06-04,2024-03,2024-03-31,2024-03-01,ACTUAL,2024-03-01,2023-04-07,ACTUAL,2023-04-07,,INTERVENTIONAL,PRESERVE3,,"Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab","A Phase 2, Randomized, Open-Label Study of Trilaciclib Administered With First-Line Platinum-Based Chemotherapy and Avelumab Maintenance Therapy in Patients With Untreated, Locally Advanced or Metastatic Urothelial Carcinoma (PRESERVE 3)",TERMINATED,,PHASE2,92.0,ACTUAL,"G1 Therapeutics, Inc.",,2.0,,Sponsor no longer pursuing trila for the indication.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,INDUSTRY,,,,,,,2024,0.0
NCT03333031,,2017-10-31,,,2023-06-14,2017-11-03,2017-11-06,ACTUAL,,,,,,,2023-06-14,2023-06-18,ACTUAL,2018-08-10,ACTUAL,2018-08-10,2023-06,2023-06-30,2022-09-07,ACTUAL,2022-09-07,2020-10-15,ACTUAL,2020-10-15,,INTERVENTIONAL,,,"A Study of HS-196, an HSP90 Inhibitor-linked NIR Probe for Solid Malignancies","A Phase I Study of HS-196, an HSP90 Inhibitor-linked Near Infrared Probe for Detection of Solid Malignancies",TERMINATED,,PHASE1,7.0,ACTUAL,Duke University,,1.0,,Funding ended,f,,,,f,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,OTHER,,,,,,,2022,0.0
NCT02017717,,2013-12-17,2022-06-02,2020-06-16,2024-07-03,2013-12-20,2013-12-23,ESTIMATED,2022-06-02,2022-06-29,ACTUAL,2020-06-16,2020-06-22,ACTUAL,2024-07-03,2024-07-16,ACTUAL,2014-02-07,ACTUAL,2014-02-07,2024-07,2024-07-31,2024-06-21,ACTUAL,2024-06-21,2019-06-17,ACTUAL,2019-06-17,,INTERVENTIONAL,CheckMate 143,"Cohorts 1b and 1c/1d (Part A) baseline characteristics are in regards to Treated Participants, while Cohorts 1, 1c/1d (Part B) and 2 baseline characteristics are in regards to Randomized Participants.",A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients,A Randomized Phase 3 Open Label Study of Nivolumab Versus Bevacizumab and Multiple Phase 1 Safety Cohorts of Nivolumab or Nivolumab in Combination With Ipilimumab Across Different Lines of Glioblastoma,COMPLETED,,PHASE3,529.0,ACTUAL,Bristol-Myers Squibb,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,INDUSTRY,,,,,,,2024,1.0
NCT04418765,,2020-06-03,2022-06-16,,2023-09-08,2020-06-03,2020-06-05,ACTUAL,2022-07-20,2022-07-22,ACTUAL,,,,2023-09-08,2023-09-29,ACTUAL,2020-06-01,ACTUAL,2020-06-01,2023-09,2023-09-30,2022-09-15,ACTUAL,2022-09-15,2021-07-15,ACTUAL,2021-07-15,,INTERVENTIONAL,DELIVER,Full analysis set (FAS) included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of monthly migraine days (MMDs) in Weeks 1 to 12.,A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments,"Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments",COMPLETED,,PHASE3,892.0,ACTUAL,H. Lundbeck A/S,,3.0,,,f,,,,t,t,f,,,,,,,,,YES,,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,INDUSTRY,,,,,,,2022,1.0
NCT03713944,,2018-10-18,2022-07-20,,2023-02-01,2018-10-19,2018-10-22,ACTUAL,2023-02-01,2023-03-01,ACTUAL,,,,2023-02-01,2023-03-01,ACTUAL,2018-11-15,ACTUAL,2018-11-15,2023-02,2023-02-28,2021-12-16,ACTUAL,2021-12-16,2021-12-16,ACTUAL,2021-12-16,,INTERVENTIONAL,,,Carboplatin Plus Pemetrexed Plus Atezolizumab Plus Bevacizumab in Chemotherapy and Immunotherapy-naïve Patients With Stage IV Non-squamous Non-small Cell Lung Cancer,A Phase II Study of Carboplatin Plus Pemetrexed Plus Atezolizumab Plus Bevacizumab in Chemotherapy and Immunotherapy-naïve Patients With Stage IV Non-squamous Non-small Cell Lung Cancer: Big Ten Cancer Research Consortium BTCRC-LUN17-139,TERMINATED,,PHASE2,30.0,ACTUAL,Big Ten Cancer Research Consortium,,1.0,,"Extreme toxicity, thromboembolic events",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,OTHER,,,,,,,2021,0.0
NCT03827655,,2019-01-30,2023-05-26,,2023-05-26,2019-01-30,2019-02-01,ACTUAL,2023-05-26,2023-06-23,ACTUAL,,,,2023-05-26,2023-06-23,ACTUAL,2019-03-07,ACTUAL,2019-03-07,2023-05,2023-05-31,2022-05-27,ACTUAL,2022-05-27,2022-05-27,ACTUAL,2022-05-27,,INTERVENTIONAL,,Randomized Set included all participants who were randomized in the study.,A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery,"A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of 2 Dose Regimens of Intravenous TAK-954 for the Prophylaxis and Treatment of Postoperative Gastrointestinal Dysfunction in Patients Undergoing Large- and Small-Bowel Resection",COMPLETED,,PHASE2,209.0,ACTUAL,Takeda,,5.0,,,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,INDUSTRY,,,,,,,2022,1.0
NCT03611751,,2018-07-25,2022-10-06,2021-11-29,2022-11-26,2018-08-01,2018-08-02,ACTUAL,2022-11-26,2022-12-20,ACTUAL,2022-11-26,2022-12-20,ACTUAL,2022-11-26,2022-12-20,ACTUAL,2018-07-26,ACTUAL,2018-07-26,2022-10,2022-10-31,2020-11-30,ACTUAL,2020-11-30,2020-11-29,ACTUAL,2020-11-29,,INTERVENTIONAL,POETYK-PSO-2,,An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis,"A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study With Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis",COMPLETED,,PHASE3,1020.0,ACTUAL,Bristol-Myers Squibb,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,INDUSTRY,,,,,,,2020,1.0
NCT03516760,,2018-04-06,,,2022-09-28,2018-05-03,2018-05-04,ACTUAL,,,,,,,2022-09-28,2022-09-29,ACTUAL,2018-04-11,ACTUAL,2018-04-11,2022-09,2022-09-30,2022-06-14,ACTUAL,2022-06-14,2022-06-14,ACTUAL,2022-06-14,,INTERVENTIONAL,,,Dose-escalating Phase I Trial With GEM333 in Patients With Acute Myeloid Leukemia,"A Multicenter, Open-label, Dose-escalating, Phase I Trial With GEM333, a CD33 Targeted Bispecific Antibody Engaging T-cells, in Relapsed or Refractory Acute Myeloid Leukemia",TERMINATED,,PHASE1,36.0,ACTUAL,AvenCell Europe GmbH,,1.0,,The actions and measures to be taken to restart the trial could not be implemented which made the premature termination inevitability.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,INDUSTRY,,,,,,,2022,0.0
NCT04628780,,2020-11-09,2024-02-12,,2024-02-12,2020-11-09,2020-11-16,ACTUAL,2024-02-12,2024-07-29,ACTUAL,,,,2024-02-12,2024-07-29,ACTUAL,2020-12-16,ACTUAL,2020-12-16,2024-02,2024-02-29,2023-05-26,ACTUAL,2023-05-26,2023-05-03,ACTUAL,2023-05-03,,INTERVENTIONAL,,Baseline analysis population included all participants who were randomized.,Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors,"A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTI-TUMOR ACTIVITY OF PF-07209960 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS",TERMINATED,,PHASE1,37.0,ACTUAL,Pfizer,"The study was planned to have 2 parts: a single agent dose escalation (Part 1) followed by a dose expansion (Part 2).~Due to the early termination of the study, Part 2 study was never initiated and the overall study consisted of only Part 1. The data displayed are from the Part 1 study which is the only 1 period of the study. Besides, the pharmacokinetic (PK) endpoints of this study were not conducted. Therefore no results of PK parameters are displayed.",4.0,,Pfizer has made an internal business decision to not continue further development of PF-07209960. This decision was not based on safety or regulatory considerations,f,,,,f,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,INDUSTRY,,,,,,,2023,0.0
NCT02164916,,2014-06-13,2017-07-13,,2020-12-07,2014-06-13,2014-06-17,ESTIMATED,2017-10-03,2017-10-31,ACTUAL,,,,2020-12-07,2020-12-30,ACTUAL,2014-11,,2014-11-30,2020-12,2020-12-31,2020-11-19,ACTUAL,2020-11-19,2017-11-13,ACTUAL,2017-11-13,,INTERVENTIONAL,,All eligible patients.,S1406 Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer,Randomized Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer,COMPLETED,,PHASE2,106.0,ACTUAL,SWOG Cancer Research Network,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,NETWORK,,,,,,,2020,1.0
NCT05250947,,2022-01-04,,,2024-07-15,2022-02-14,2022-02-22,ACTUAL,,,,,,,2024-07-15,2024-07-17,ACTUAL,2023-01-05,ACTUAL,2023-01-05,2024-07,2024-07-31,2024-05-20,ACTUAL,2024-05-20,2024-05-20,ACTUAL,2024-05-20,,INTERVENTIONAL,,,Study Evaluating the Safety and Feasibility of Platelet-rich Plasma to Treat Facetogenic Low Back Pain,A Phase I Study Evaluating the Safety and Feasibility of Platelet-rich Plasma for the Treatment of Facetogenic Low Back Pain,TERMINATED,,PHASE1,4.0,ACTUAL,Mayo Clinic,,1.0,,Projected cost to continue was not supported by the study budget and additional funds could not be obtained so the decision to close the study was made.,f,,,,f,t,t,,,,,,,,,NO,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,OTHER,,,,,,,2024,0.0
NCT04994106,,2021-07-29,,,2022-10-04,2021-07-29,2021-08-06,ACTUAL,,,,,,,2022-10-04,2022-10-05,ACTUAL,2021-07-27,ACTUAL,2021-07-27,2022-10,2022-10-31,2022-09-20,ACTUAL,2022-09-20,2022-09-20,ACTUAL,2022-09-20,,INTERVENTIONAL,,,"A Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD5462 Following Single and Multiple Ascending Dose Administration to Healthy Volunteers","A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD5462 Following Single and Multiple Ascending Dose Administration to Healthy Volunteers",COMPLETED,,PHASE1,98.0,ACTUAL,AstraZeneca,,17.0,,,,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:~https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patientlevel data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:~https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,INDUSTRY,,,,,,,2022,0.0
NCT04340544,,2020-04-03,,,2020-10-29,2020-04-08,2020-04-09,ACTUAL,,,,,,,2020-10-29,2020-11-02,ACTUAL,2020-04-22,ACTUAL,2020-04-22,2020-04,2020-04-30,2020-10-12,ACTUAL,2020-10-12,2020-10-12,ACTUAL,2020-10-12,,INTERVENTIONAL,COMIHY,,Hydroxychloroquine for the Treatment of Mild COVID-19 Disease,Hydroxychloroquine for the Treatment of Mild COVID-19 Disease,TERMINATED,,PHASE2,17.0,ACTUAL,University Hospital Tuebingen,,2.0,,"It appeared to be impossible for the study centres to recruit the targeted number of patients, due to reduced incidence and reduced acceptance to IMP",f,,,,t,f,f,,,,,,,,,,,2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,OTHER,,,,,,,2020,0.0
NCT04100330,,2019-09-12,,,2020-03-27,2019-09-20,2019-09-24,ACTUAL,,,,,,,2020-03-27,2020-03-31,ACTUAL,2020-01-31,ESTIMATED,2020-01-31,2020-03,2020-03-31,2020-03-27,ACTUAL,2020-03-27,2020-03-27,ACTUAL,2020-03-27,,INTERVENTIONAL,CyFi2,,A Study of Ficlatuzumab With HiDAC and HiDAC Alone in Adults With Relapsed or Refractory Acute Myeloid Leukemia,"A Phase 2, Randomized, Open-Label, Multicenter Study of Ficlatuzumab in Combination With High-Dose Cytarabine (HiDAC) and HiDAC Alone in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)",WITHDRAWN,,PHASE2,0.0,ACTUAL,"AVEO Pharmaceuticals, Inc.",,2.0,,Urgent shift among clinical sites toward efforts to combat COVID-19 pandemic;impacted feasibility of completing study within shelf-life of current IP supply,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,INDUSTRY,,,,,,,2020,0.0
NCT02706873,,2016-02-18,2019-09-13,2019-03-08,2023-06-21,2016-03-08,2016-03-11,ESTIMATED,2019-09-13,2019-10-04,ACTUAL,2019-03-08,2019-03-12,ACTUAL,2023-06-21,2023-07-07,ACTUAL,2016-02-23,ACTUAL,2016-02-23,2023-06,2023-06-30,2022-11-10,ACTUAL,2022-11-10,2018-03-15,ACTUAL,2018-03-15,,INTERVENTIONAL,SELECT-EARLY,The full analysis set included all randomized participants who received at least 1 dose of study drug.,A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate,"A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis",COMPLETED,,PHASE3,1002.0,ACTUAL,AbbVie,,4.0,,,f,,,,t,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,INDUSTRY,,,,,,,2022,1.0
NCT03610061,,2017-11-14,,,2024-04-11,2018-07-25,2018-08-01,ACTUAL,,,,,,,2024-04-11,2024-04-12,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2024-04,2024-04-30,2024-04-08,ACTUAL,2024-04-08,2023-04-05,ACTUAL,2023-04-05,,INTERVENTIONAL,RaDD,,A Trial of Radiotherapy and Durvalumab in DLBCL and FL,Phase I Dose Escalation Study of Radiotherapy and Durvalumab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma (FL): The RaDD Study,COMPLETED,,PHASE1,34.0,ACTUAL,Austin Health,,1.0,,,f,,,,t,f,f,,,f,,,,,,UNDECIDED,IPD is the property of the Sponsor (Olivia Newton John Cancer Research Institute). Results from the research intends to be published/presented in relevant publications/conferences for colleague review,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,OTHER_GOV,,,,,,,2024,1.0
NCT05571111,,2022-09-28,,,2023-01-05,2022-10-04,2022-10-07,ACTUAL,,,,,,,2023-01-05,2023-01-09,ACTUAL,2022-10-04,ACTUAL,2022-10-04,2022-07,2022-07-31,2024-06-25,ESTIMATED,2024-06-25,2024-03-25,ESTIMATED,2024-03-25,,INTERVENTIONAL,TIFFANY,,Clinical Research Study to Learn About the Effect and Safety of Different Doses of FE 999302 When Given as a Single Dose for Final Development of the Eggs After Ovarian Stimulation,"A Randomised, Assessor-blind, Active-controlled, Parallel-group, Dose-finding Trial to Investigate the Efficacy and Safety of FE 999302 for Triggering of Final Follicular Maturation in Women Undergoing Controlled Ovarian Stimulation",WITHDRAWN,,PHASE2,0.0,ACTUAL,Ferring Pharmaceuticals,,5.0,,Based on company decision to close the project. No trial participants received any study drug.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,INDUSTRY,,,,,,,2024,0.0
NCT03682497,,2018-09-21,,,2020-04-30,2018-09-21,2018-09-24,ACTUAL,,,,,,,2020-04-30,2020-05-01,ACTUAL,2018-11-01,ACTUAL,2018-11-01,2020-04,2020-04-30,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,,Study in HFpEF Patients to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium,"A Phase I, Open Label, Randomized, Parallel Group, Multicentre Study to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium [sK+] During 28 Days in Patients With HFmrEF or HFpEF and eGFR in the Range of ≥40 and ≤70 mL/Min/1.73m2.",TERMINATED,,PHASE1,68.0,ACTUAL,AstraZeneca,,2.0,,Attendance at study sites carries risk of COVID-19 infection. Non-attendance at planned study site visits has unacceptable study related patient safety risk.,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,INDUSTRY,,,,,,,2020,0.0
NCT04616079,,2020-10-29,,,2021-11-04,2020-10-29,2020-11-04,ACTUAL,,,,,,,2021-11-04,2021-11-11,ACTUAL,2020-11-19,ACTUAL,2020-11-19,2021-11,2021-11-30,2021-06-01,ACTUAL,2021-06-01,2021-06-01,ACTUAL,2021-06-01,,INTERVENTIONAL,,,Ascending Dose Study of the Safety and Tolerability of REGN6490 in Healthy Volunteers,"A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of REGN6490 in Healthy Volunteers",TERMINATED,,PHASE1,57.0,ACTUAL,Regeneron Pharmaceuticals,,8.0,,Sponsor decision,f,,,,f,f,f,,,,,,"Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.","Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (eg, FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).",https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,INDUSTRY,,,,,,,2021,0.0
NCT03115151,,2017-04-11,2023-08-31,,2023-10-24,2017-04-11,2017-04-14,ACTUAL,2023-10-24,2023-10-26,ACTUAL,,,,2023-10-24,2023-10-26,ACTUAL,2017-05-08,ACTUAL,2017-05-08,2023-10,2023-10-31,2023-04-04,ACTUAL,2023-04-04,2022-08-18,ACTUAL,2022-08-18,,INTERVENTIONAL,,,Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery,A Comparison of Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery: A Prospective Randomized Study,TERMINATED,,PHASE4,46.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,The surgical team has difficulty to find level 1 and 2 fusions for the study.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,OTHER,,,,,,,2023,0.0
NCT03860155,,2019-01-31,,,2021-11-09,2019-02-28,2019-03-01,ACTUAL,,,,,,,2021-11-09,2021-11-17,ACTUAL,2019-03-22,ACTUAL,2019-03-22,2021-09,2021-09-30,2021-03-26,ACTUAL,2021-03-26,2021-03-26,ACTUAL,2021-03-26,,INTERVENTIONAL,,,Allogeneic ABCB5-positive Stem Cells for Treatment of Acute-on-Chronic Liver Failure,"An Interventional, Single Arm, Multicenter, Phase I/IIa Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-ACLF for the Treatment of Acute-on-Chronic Liver Failure (ACLF)",TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,RHEACELL GmbH & Co. KG,,1.0,,Very slow recruitment of patients and the current COVID-19 pandemic situation.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,INDUSTRY,,,,,,,2021,0.0
NCT03602872,,2018-07-17,,,2020-07-13,2018-07-25,2018-07-27,ACTUAL,,,,,,,2020-07-13,2020-07-15,ACTUAL,2019-08,ESTIMATED,2019-08-31,2020-07,2020-07-31,2020-04,ESTIMATED,2020-04-30,2020-04,ESTIMATED,2020-04-30,,INTERVENTIONAL,,,Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells in Subjects With Osteoarthritis,"Phase I, Open Label Study to Assess the Safety and Tolerance of a Single Intraarticular Dose of STEMEDICA's Human Allogeneic Bone Marrow Derived Mesenchymal Stem Cells, in Subjects With Knee Osteoarthritis.",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Clinica Santa Clarita, Mexico",,3.0,,"Sponsor to start with different protocol, postponed due to COVID",f,,,,,t,f,,,t,,,,,,NO,,2024-10-16 03:51:32.670393,2024-10-16 03:51:32.670393,INDUSTRY,,,,,,,2020,0.0
NCT03948178,,2019-05-07,2022-11-02,,2023-02-09,2019-05-10,2019-05-13,ACTUAL,2023-02-09,2023-03-09,ACTUAL,,,,2023-02-09,2023-03-09,ACTUAL,2019-06-26,ACTUAL,2019-06-26,2023-02,2023-02-28,2020-11-18,ACTUAL,2020-11-18,2020-11-18,ACTUAL,2020-11-18,,INTERVENTIONAL,REFALS-ES,Intention-to-Treat (ITT) including all randomised subjects was used for the primary evaluation.,Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension,Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS: Open-Label Extension for Patients Completing Study 3119002,TERMINATED,,PHASE3,227.0,ACTUAL,"Orion Corporation, Orion Pharma",,1.0,,This was an open label extension for patients completing the REFALS study (3119002; NCT03505021). Study 3119002 showed lack of efficacy of ODM109 so the sponsor decided to terminate this study,,,,,f,t,f,,,,,,,,,,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,INDUSTRY,,,,,,,2020,0.0
NCT04941196,,2021-06-19,,,2022-09-05,2021-06-25,2021-06-28,ACTUAL,,,,,,,2022-09-05,2022-09-08,ACTUAL,2020-10-16,ACTUAL,2020-10-16,2022-09,2022-09-30,2020-11-25,ACTUAL,2020-11-25,2020-10-26,ACTUAL,2020-10-26,,INTERVENTIONAL,BE,,Bioequivalence Study of Anplag® 90mg (Ticagrelor) Tablet & Brilinta® 90 mg (Ticagrelor) Tablet in Healthy Adult Male Pakistani Subjects Under Fasting Condition,"A Single Centre, Cross-over, Single Dose, Two Period, Randomized, Open Label Bioequivalence Study of Anplag® 90mg (Ticagrelor) Tablet With Brilinta® 90 mg (Ticagrelor) Tablet in Healthy Adult Male Pakistani Subjects Under Fasting Condition",COMPLETED,,PHASE1,30.0,ACTUAL,University of Karachi,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,Data can be obtained upon proper request to principal investigator unless the volunteer's confidentiality is not compromised.,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,OTHER,,,,,,,2020,1.0
NCT03311555,,2017-09-26,2023-11-16,,2024-02-19,2017-10-11,2017-10-17,ACTUAL,2024-02-19,2024-03-19,ACTUAL,,,,2024-02-19,2024-03-19,ACTUAL,2018-03-28,ACTUAL,2018-03-28,2024-02,2024-02-29,2022-12-22,ACTUAL,2022-12-22,2022-12-22,ACTUAL,2022-12-22,,INTERVENTIONAL,,,A Salvage Trial of AR Inhibition With ADT and Apalutamide With Radiation Therapy Followed by Docetaxel in Men With PSA Recurrent Prostate Cancer After Radical Prostatectomy (STARTAR),A Salvage Trial of AR Inhibition With ADT and Apalutamide With Radiation Therapy Followed by Docetaxel in Men With PSA Recurrent Prostate Cancer After Radical Prostatectomy (STARTAR),COMPLETED,,PHASE2,39.0,ACTUAL,Duke University,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,OTHER,,,,,,,2022,1.0
NCT03740100,,2018-11-01,2021-09-07,,2023-07-11,2018-11-12,2018-11-14,ACTUAL,2021-12-22,2022-01-20,ACTUAL,,,,2023-07-11,2023-07-14,ACTUAL,2019-01-25,ACTUAL,2019-01-25,2023-07,2023-07-31,2020-12-09,ACTUAL,2020-12-09,2020-08-05,ACTUAL,2020-08-05,,INTERVENTIONAL,HNSCC,,Single-arm Study With Bimiralisib in Patients With HNSCC Harboring NOTCH1 Loss of Function Mutations,"Open-label, Single Arm, Two-stage Study, Evaluating the Efficacy and Safety of Bimiralisib in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinomas (HNSCC) Harboring NOTCH1 Loss of Function (LOF) Mutations",TERMINATED,,PHASE2,8.0,ACTUAL,M.D. Anderson Cancer Center,The trial was closed early because the sponsor became insolvent.,1.0,,The trial was closed because the sponsor became insolvent.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,OTHER,,,,,,,2020,0.0
NCT03497988,,2018-03-19,,,2018-12-21,2018-04-06,2018-04-13,ACTUAL,,,,,,,2018-12-21,2018-12-26,ACTUAL,2018-09,ESTIMATED,2018-09-30,2018-12,2018-12-31,2021-06,ESTIMATED,2021-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,Intranasal Oxytocin and Food Intake in Obese Adolescents,Effect of a Single Dose of Intranasal Oxytocin on Food Intake in Obese Adolescents,WITHDRAWN,,PHASE2,0.0,ACTUAL,Children's Hospital of Philadelphia,,2.0,,"Grant proposal not funded, study has been withdrawn with IRB",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,OTHER,,,,,,,2021,0.0
NCT03672292,,2018-09-11,2024-05-15,,2024-08-01,2018-09-12,2018-09-14,ACTUAL,2024-08-01,2024-08-09,ACTUAL,,,,2024-08-01,2024-08-09,ACTUAL,2019-01-22,ACTUAL,2019-01-22,2024-08,2024-08-31,2023-03-27,ACTUAL,2023-03-27,2023-03-27,ACTUAL,2023-03-27,,INTERVENTIONAL,SCYNERGIA,,Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis,"A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Coadministration of SCY-078 With Voriconazole in Patients With Invasive Pulmonary Aspergillosis",TERMINATED,,PHASE2,22.0,ACTUAL,"Scynexis, Inc.",,2.0,,Enrollment took longer than anticipated (slow enrollment during COVID).,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,INDUSTRY,,,,,,,2023,0.0
NCT04232839,,2020-01-15,2022-09-26,,2024-04-12,2020-01-15,2020-01-18,ACTUAL,2024-04-12,2024-09-19,ACTUAL,,,,2024-04-12,2024-09-19,ACTUAL,2020-02-25,ACTUAL,2020-02-25,2024-04,2024-04-30,2020-11-30,ACTUAL,2020-11-30,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,,Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.,A Study in Healthy Men to Find the Best Formulation of BI 894416 and to Test How This is Taken up in the Body,"Formulation Selection and Subsequent Optimization of Two Different Oral Formulations of BI 894416 in Healthy Male Subjects (Open-label, Randomised, Single-dose Study in Two Parts; Trial Part 1: Five-period Crossover Design With an Additional Sixth Period in a Fixed Sequence; Trial Part 2: Three-period Crossover Followed by a Two-period Crossover Design)",TERMINATED,,PHASE1,24.0,ACTUAL,Boehringer Ingelheim,,10.0,,Due to company decision.,f,,,,f,f,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).For more details refer to: http://trials.boehringer-ingelheim.com/",2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,INDUSTRY,,,,,,,2020,0.0
NCT03412773,,2018-01-03,,2023-06-30,2024-01-08,2018-01-21,2018-01-26,ACTUAL,,,,,2023-07-05,ACTUAL,2024-01-08,2024-01-10,ACTUAL,2017-12-28,ACTUAL,2017-12-28,2024-01,2024-01-31,2023-12-14,ACTUAL,2023-12-14,2022-07-11,ACTUAL,2022-07-11,,INTERVENTIONAL,,,Phase 3 Study of Tislelizumab Versus Sorafenib in Participants With Unresectable HCC,"RATIONALE-301: A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma",COMPLETED,,PHASE3,674.0,ACTUAL,BeiGene,,2.0,,,,,,,,t,f,,,,,,,,,YES,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,INDUSTRY,,,,,,,2023,1.0
NCT03933865,,2018-12-04,,,2022-10-06,2019-04-30,2019-05-01,ACTUAL,,,,,,,2022-10-06,2022-10-10,ACTUAL,2018-10-31,ACTUAL,2018-10-31,2022-10,2022-10-31,2022-02-24,ACTUAL,2022-02-24,2022-02-24,ACTUAL,2022-02-24,,INTERVENTIONAL,,,Acute Pain Management in Patients on Opioid Replacement Therapy,Acute Pain Management in Patients on Opioid Replacement Therapy,TERMINATED,,PHASE1,1.0,ACTUAL,"University of California, San Francisco",,1.0,,The COVID-19 pandemic and recruitment difficulties prompted the investigators to terminate study early.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,OTHER,,,,,,,2022,0.0
NCT01799889,,2013-02-13,2020-09-02,2018-09-07,2020-11-02,2013-02-25,2013-02-27,ESTIMATED,2020-09-02,2020-09-23,ACTUAL,2018-09-07,2018-09-12,ACTUAL,2020-11-02,2020-11-19,ACTUAL,2013-03-14,ACTUAL,2013-03-14,2020-11,2020-11-30,2020-01-30,ACTUAL,2020-01-30,2017-09-14,ACTUAL,2017-09-14,,INTERVENTIONAL,,The Full Analysis Set included all enrolled participants who took at least one dose of study drug with treatment group designated according to the planned treatment.,"Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Entospletinib in Adults With Relapsed or Refractory Hematologic Malignancies","A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects With Relapsed or Refractory Hematologic Malignancies",TERMINATED,,PHASE2,326.0,ACTUAL,Gilead Sciences,Study was terminated prematurely due to sponsor's decision to discontinue development of entospletinib.,12.0,,Sponsor's decision to discontinue development of entospletinib.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,INDUSTRY,,,,,,,2020,0.0
NCT02867761,,2016-08-12,2022-07-07,,2023-04-11,2016-08-12,2016-08-16,ESTIMATED,2022-08-08,2022-08-30,ACTUAL,,,,2023-04-11,2023-04-13,ACTUAL,2017-08-29,ACTUAL,2017-08-29,2023-04,2023-04-30,2021-07-07,ACTUAL,2021-07-07,2021-07-07,ACTUAL,2021-07-07,,INTERVENTIONAL,RETHINC,,RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative,RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative,COMPLETED,,PHASE3,780.0,ACTUAL,University of Michigan,,2.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,OTHER,,,,,,,2021,1.0
NCT05006885,,2021-07-30,,,2023-07-24,2021-08-13,2021-08-16,ACTUAL,,,,,,,2023-07-24,2023-07-27,ACTUAL,2021-09-30,ACTUAL,2021-09-30,2023-07,2023-07-31,2022-08-17,ACTUAL,2022-08-17,2022-08-17,ACTUAL,2022-08-17,,INTERVENTIONAL,,,ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD),"A Phase 1, 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease",COMPLETED,,PHASE1,95.0,ACTUAL,"Altimmune, Inc.",,4.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,INDUSTRY,,,,,,,2022,1.0
NCT04638491,,2020-11-05,,,2024-06-06,2020-11-16,2020-11-20,ACTUAL,,,,,,,2024-06-06,2024-06-10,ACTUAL,2020-11-24,ACTUAL,2020-11-24,2024-06,2024-06-30,2023-11-04,ACTUAL,2023-11-04,2023-11-04,ACTUAL,2023-11-04,,INTERVENTIONAL,,,Safety Tolerability Pharmacokinetic and Preliminary Efficacy in Chinese Advanced Solid Tumors Patients,"Phase 1, Single-arm, Open-label, Dose Escalating and Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of Lurbinectedin (PM01183) for Injection in Patients With Advanced Solid Tumors",COMPLETED,,PHASE1,32.0,ACTUAL,Luye Pharma Group Ltd.,,1.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,INDUSTRY,,,,,,,2023,1.0
NCT02298595,,2014-11-11,,,2017-11-08,2014-11-19,2014-11-24,ESTIMATED,,,,,,,2017-11-08,2017-11-13,ACTUAL,2016-08,,2016-08-31,2017-11,2017-11-30,2024-08,ESTIMATED,2024-08-31,2019-08,ESTIMATED,2019-08-31,,INTERVENTIONAL,,,"Cetuximab, Cisplatin and BYL719 for HPV-Associated Oropharyngeal Squamous Cell Carcinoma","A Phase I/II Study of BYL719, Cetuximab, and Cisplatin in Transorally Resectable, HPV-Associated Oropharyngeal Squamous Cell Carcinoma",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Pittsburgh,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 12:54:20.632388,2024-10-16 12:54:20.632388,OTHER,,,,,,,2024,0.0
NCT03499795,,2018-04-09,2023-06-12,2021-06-15,2023-07-11,2018-04-13,2018-04-17,ACTUAL,2023-06-12,2023-07-03,ACTUAL,2021-06-15,2021-06-18,ACTUAL,2023-07-11,2023-07-14,ACTUAL,2018-05-15,ACTUAL,2018-05-15,2023-07,2023-07-31,2021-05-26,ACTUAL,2021-05-26,2020-06-16,ACTUAL,2020-06-16,,INTERVENTIONAL,,mITT population included all participants who received at least 1 dose of VGX-3100+EP.,"VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL) in Individuals Seronegative for Human Immunodeficiency Virus (HIV)-1/2","A Phase 2, Open Label, Study of VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL), (AIN2, AIN3, PAIN2, PAIN3) in Individuals That Are Seronegative for Human Immunodeficiency Virus (HIV)-1/2",COMPLETED,,PHASE2,23.0,ACTUAL,Inovio Pharmaceuticals,,1.0,,,f,,,,,t,t,t,,,,,,,,NO,,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,INDUSTRY,,,,,,,2021,1.0
NCT03187769,,2017-06-08,2022-12-22,,2022-12-22,2017-06-13,2017-06-15,ACTUAL,2022-12-22,2023-01-19,ACTUAL,,,,2022-12-22,2023-01-19,ACTUAL,2017-06-08,ACTUAL,2017-06-08,2022-12,2022-12-31,2022-01-03,ACTUAL,2022-01-03,2021-12-01,ACTUAL,2021-12-01,,INTERVENTIONAL,,The baseline analysis population includes all randomized subjects who received at least 1 dose of study drug,"Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder","A Study to Evaluate the Effect of ALKS 3831 Compared to Olanzapine on Body Weight in Young Adults With Schizophrenia, Schizophreniform, or Bipolar I Disorder Who Are Early in Their Illness",COMPLETED,,PHASE3,426.0,ACTUAL,"Alkermes, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,INDUSTRY,,,,,,,2022,1.0
NCT01849874,,2013-05-06,2021-03-03,2017-04-03,2023-10-26,2013-05-07,2013-05-09,ESTIMATED,2021-03-03,2021-03-30,ACTUAL,2017-04-03,2017-04-04,ACTUAL,2023-10-26,2023-10-30,ACTUAL,2013-06-27,ACTUAL,2013-06-27,2023-10,2023-10-31,2022-08-23,ACTUAL,2022-08-23,2016-01-20,ACTUAL,2016-01-20,,INTERVENTIONAL,,Baseline analysis population included all participants in the safety population. Safety population consisted of all participants who received at any dose of study intervention (MEK162 or physician's choice chemotherapy).,"A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer","The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer): A Multinational, Randomized, Open-label Phase 3 Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum",TERMINATED,,PHASE3,341.0,ACTUAL,Pfizer,"In the futility analysis based on PCD, the futility boundary was crossed, and therefore, no additional efficacy data was collected and no additional efficacy analyses were conducted. As of 01 Apr 2016, enrollment into the study were discontinued and crossover treatment was no longer permitted, any participants still receiving MEK162 were allowed to continue at the discretion of the investigator until any treatment discontinuation criterion was met and discontinued after 30-day safety follow up.",2.0,,"Per recommendation of the DMC, enrollment into the study was discontinued in April 2016 after the planned interim efficacy analysis showed the hazard ratio for PFS crossed the predefined futility boundary.",f,,,,t,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,INDUSTRY,,,,,,,2022,0.0
NCT03527264,,2018-05-04,2022-03-02,,2022-03-30,2018-05-15,2018-05-17,ACTUAL,2022-03-30,2022-04-26,ACTUAL,,,,2022-03-30,2022-04-26,ACTUAL,2018-11-08,ACTUAL,2018-11-08,2022-03,2022-03-31,2020-11-13,ACTUAL,2020-11-13,2020-11-13,ACTUAL,2020-11-13,,INTERVENTIONAL,,Study was terminated prior to enrolling patients in cohort 2 \& cohort 3.,BrUOG 355: Nivolumab to Tailored Radiation Therapy With Concomitant Cisplatin in the Treatment of Patients With Cervical Cancer,BrUOG 355: A Pilot Feasibility Study Incorporating Nivolumab to Tailored Radiation Therapy With Concomitant Cisplatin in the Treatment of Patients With Cervical Cancer,TERMINATED,,PHASE2,4.0,ACTUAL,Brown University,,4.0,,Slow enrollment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,OTHER,,,,,,,2020,0.0
NCT03107793,,2017-03-28,2021-04-28,,2023-08-16,2017-04-04,2017-04-11,ACTUAL,2021-04-28,2021-05-19,ACTUAL,,,,2023-08-16,2023-08-21,ACTUAL,2017-04-19,ACTUAL,2017-04-19,2023-08,2023-08-31,2021-07-20,ACTUAL,2021-07-20,2020-04-30,ACTUAL,2020-04-30,,INTERVENTIONAL,STARDUST,,Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab,Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab,COMPLETED,,PHASE3,500.0,ACTUAL,Janssen-Cilag Ltd.,,4.0,,,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,INDUSTRY,,,,,,,2021,1.0
NCT04082000,,2019-08-31,,,2021-03-22,2019-09-05,2019-09-09,ACTUAL,,,,,,,2021-03-22,2021-03-24,ACTUAL,2019-04-15,ACTUAL,2019-04-15,2021-03,2021-03-31,2020-11-04,ACTUAL,2020-11-04,2020-11-04,ACTUAL,2020-11-04,,INTERVENTIONAL,,,Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 for Treating Diabetic Neuropathy,A Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 Sublingual Drops for Treating Diabetic Neuropathy,TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,Breath of Life International Pharma Ltd,,2.0,,study stopped due to company strategic prioritization,f,,,,f,f,f,,,,,,,,,,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,INDUSTRY,,,,,,,2020,0.0
NCT00896493,,2009-05-07,2023-03-28,,2023-05-09,2009-05-08,2009-05-11,ESTIMATED,2023-05-09,2023-05-11,ACTUAL,,,,2023-05-09,2023-05-11,ACTUAL,2009-05,,2009-05-31,2023-05,2023-05-31,2022-12,ACTUAL,2022-12-31,2021-11-06,ACTUAL,2021-11-06,,INTERVENTIONAL,,,Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma,A Phase II Study of Non-myeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) In Patients With Cutaneous T Cell Lymphoma,COMPLETED,,PHASE2,38.0,ACTUAL,Stanford University,,1.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,OTHER,,,,,,,2022,1.0
NCT04121143,,2019-09-27,,,2020-03-19,2019-10-08,2019-10-09,ACTUAL,,,,,,,2020-03-19,2020-03-23,ACTUAL,2019-11-09,ACTUAL,2019-11-09,2020-03,2020-03-31,2020-12-30,ESTIMATED,2020-12-30,2020-06-30,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,A Clinical Study of SHR-1314 Injection in the Treatment of Moderate to Severe Plaque Psoriasis in Adults,"Multicenter, Placebo-controlled, Parallel-randomized, Double-blind, Phase II Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of SHR-1314 Injection With Moderate to Severe Plaque Psoriasis in Adults",SUSPENDED,,PHASE2,120.0,ESTIMATED,"Jiangsu HengRui Medicine Co., Ltd.",,4.0,,sponsor's decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,INDUSTRY,,,,,,,2020,0.0
NCT05166876,,2021-12-16,2023-01-10,,2023-10-11,2021-12-16,2021-12-22,ACTUAL,2023-02-03,2023-02-06,ACTUAL,,,,2023-10-11,2023-11-07,ACTUAL,2022-02-01,ACTUAL,2022-02-01,2023-10,2023-10-31,2022-06-04,ACTUAL,2022-06-04,2022-06-04,ACTUAL,2022-06-04,,INTERVENTIONAL,CCBCRISIS04,,Brequinar Combined With Dipyridamole in Patients With Mild to Moderate COVID-19,"A Phase II, Randomized, Assessor-blind, Multicenter, Multi-dose, Placebo-controlled Study Assessing the Safety and Anti-coronavirus Response of Brequinar Combined With Dipyridamole in Patients With Mild to Moderate SARS-CoV-2 Infection.",TERMINATED,,PHASE2,26.0,ACTUAL,"Clear Creek Bio, Inc.",,3.0,,Low prevalence of COVID-19 in India led to lack of eligible subjects.,f,,,,t,t,f,,,,,,,,,,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,INDUSTRY,,,,,,,2022,0.0
NCT04786600,,2021-03-04,,,2024-06-17,2021-03-04,2021-03-08,ACTUAL,,,,,,,2024-06-17,2024-06-20,ACTUAL,2022-03-14,ACTUAL,2022-03-14,2024-06,2024-06-30,2024-03-19,ACTUAL,2024-03-19,2024-03-19,ACTUAL,2024-03-19,,INTERVENTIONAL,,,A Phase II Randomized Therapeutic Optimization Trial for Subjects With Refractory Metastatic Colorectal Cancer Using ctDNA: Rapid 1 Trial,A Phase II Randomized Therapeutic Optimization Trial for Subjects With Refractory Metastatic Colorectal Cancer Using ctDNA: Rapid 1 Trial,TERMINATED,,PHASE2,6.0,ACTUAL,University of Florida,,2.0,,slow accrual,f,,,,t,f,t,,,f,,,,,,,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,OTHER,,,,,,,2024,0.0
NCT03539731,,2018-05-16,,,2024-08-08,2018-05-25,2018-05-29,ACTUAL,,,,,,,2024-08-08,2024-08-12,ACTUAL,2018-04-23,ACTUAL,2018-04-23,2024-08,2024-08-31,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,[18F]DASA-23 and PET Scan in Evaluating Pyruvate Kinase M2 Expression in Patients With Intracranial Tumors or Recurrent Glioblastoma and Healthy Volunteers,A Phase I Study of [18F]DASA-23 as a PET Tracer for Evaluating Pyruvate Kinase M2 (PKM2) Expression in Healthy Volunteers and in Patients With Intracranial Tumors,TERMINATED,,PHASE1,27.0,ACTUAL,Stanford University,,4.0,,study did not meet its objectives due to difficulties in enrollment,,,,,,t,f,,,,,,,,,,,2024-10-16 13:00:33.526766,2024-10-16 13:00:33.526766,OTHER,,,,,,,2022,0.0
NCT04035317,,2019-07-23,,,2021-01-26,2019-07-25,2019-07-29,ACTUAL,,,,,,,2021-01-26,2021-01-28,ACTUAL,2017-10-31,ACTUAL,2017-10-31,2021-01,2021-01-31,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Aesculus Hippocastanum L. on Fontan Circulation,"Effect of Aesculus Hippocastanum L. (Sapindaceae, Horse Chestnut) on Fontan Circulation - a Randomized Clinical Trial",WITHDRAWN,,PHASE2,0.0,ACTUAL,Casa Espirita Terra de Ismael,,2.0,,The graduate student quit.,f,,,,f,f,f,,,f,,,,,,,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,OTHER,,,,,,,2020,0.0
NCT05554627,,2022-09-21,,,2024-01-03,2022-09-21,2022-09-26,ACTUAL,,,,,,,2024-01-03,2024-01-05,ACTUAL,2023-10-27,ACTUAL,2023-10-27,2024-01,2024-01-31,2023-10-27,ACTUAL,2023-10-27,2023-10-27,ACTUAL,2023-10-27,,INTERVENTIONAL,VAST-D II,,VA Aripiprazole vs Esketamine for Treatment Resistant Depression,VA Aripiprazole vs. Esketamine for Treatment of Depression VAST-D II,WITHDRAWN,,PHASE4,0.0,ACTUAL,VA Office of Research and Development,,2.0,,Study funding was withdrawn by study sponsor (CSR\&D) prior to enrollment due to budget constraints.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,FED,,,,,,,2023,0.0
NCT04539730,,2020-08-31,,,2021-12-06,2020-08-31,2020-09-07,ACTUAL,,,,,,,2021-12-06,2021-12-22,ACTUAL,2021-12-01,ESTIMATED,2021-12-01,2021-12,2021-12-31,2022-12-01,ESTIMATED,2022-12-01,2022-12-01,ESTIMATED,2022-12-01,,INTERVENTIONAL,,,Liposomal Bupivacaine in Adductor Canal Blocks (ACB),"Does the Addition of Liposomal Bupivacaine to the Adductor Canal Block Impact Narcotic Use After Primary Total Knee Arthroplasty: a Prospective, Blind Randomized Control Trial",WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Miami,,2.0,,Did not acquire funding to pursue study,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,OTHER,,,,,,,2022,0.0
NCT04357795,,2020-04-08,2023-09-05,,2024-01-16,2020-04-20,2020-04-22,ACTUAL,2024-01-16,2024-02-06,ACTUAL,,,,2024-01-16,2024-02-06,ACTUAL,2020-06-29,ACTUAL,2020-06-29,2023-10,2023-10-31,2022-06-24,ACTUAL,2022-06-24,2022-06-24,ACTUAL,2022-06-24,,INTERVENTIONAL,,,Effect of Cequa™ in Subjects With Dry Eye Disease,Effect of Cequa™ in Subjects With Dry Eye Disease That Is Currently Inadequately Controlled While on Cyclosporine 0.05% Ophthalmic Emulsion,COMPLETED,,PHASE4,135.0,ACTUAL,Sun Pharmaceutical Industries Limited,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,INDUSTRY,,,,,,,2022,1.0
NCT03382574,,2017-12-22,2022-05-23,,2022-05-23,2017-12-22,2017-12-26,ACTUAL,2022-05-23,2022-06-14,ACTUAL,,,,2022-05-23,2022-06-14,ACTUAL,2019-03-14,ACTUAL,2019-03-14,2022-05,2022-05-31,2021-10-22,ACTUAL,2021-10-22,2021-10-22,ACTUAL,2021-10-22,,INTERVENTIONAL,,"2 participants consented at Tel Aviv Sourasky Medical Center, no participants randomized nor received trial intervention combined arms due to the participants were not randomized.",Pilot Study of Denosumab in BRCA1/2 Mutation Carriers Scheduled for Risk-Reducing Salpingo-Oophorectomy,Pilot Study of Denosumab in BRCA1/2 Mutation Carriers Scheduled for Risk-Reducing Salpingo-Oophorectomy,TERMINATED,,EARLY_PHASE1,2.0,ACTUAL,National Cancer Institute (NCI),,2.0,,"it was decided that due to lack of accrual on the trial, and low potential for accruing over the near future, the trial will be shut down.",f,,,,t,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page",2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,NIH,,,,,,,2021,0.0
NCT03037645,,2017-01-25,,,2020-10-15,2017-01-30,2017-01-31,ESTIMATED,,,,,,,2020-10-15,2020-10-19,ACTUAL,2017-04-28,ACTUAL,2017-04-28,2020-10,2020-10-31,2020-08-31,ACTUAL,2020-08-31,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,,,"Safety, PK, PD, and Antitumor Activity of Vecabrutinib (SNS-062) in B Lymphoid Cancers","A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study of the Noncovalent, Reversible Bruton's Tyrosine Kinase Inhibitor, SNS-062, in Patients With B-Lymphoid Malignancies",TERMINATED,,PHASE1/PHASE2,39.0,ACTUAL,Sunesis Pharmaceuticals,,1.0,,"Phase 1b portion completed. Sponsor decided not to proceed with P2 portion of study. Vecabrutinib was very well tolerated, there was insufficient evidence of activity at the doses tested in the Phase 1b to advance to Phase 2.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,INDUSTRY,,,,,,,2020,0.0
NCT04760665,,2021-02-15,,,2024-07-08,2021-02-17,2021-02-18,ACTUAL,,,,,,,2024-07-08,2024-07-09,ACTUAL,2021-10-04,ACTUAL,2021-10-04,2024-07,2024-07-31,2023-11-24,ACTUAL,2023-11-24,2023-11-24,ACTUAL,2023-11-24,,INTERVENTIONAL,KAPEDIS,,Clinical Trial to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae,"Randomized, Superiority, Double Blind Controlled With Placebo, Clinical Trial, to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Klebsiella Pneumoniae Carbapenemase (KPC)-Producing",TERMINATED,,PHASE2,2.0,ACTUAL,Maimónides Biomedical Research Institute of Córdoba,,2.0,,lack of elegible population,f,,,,f,f,f,,,,,,After publishing the results in a journal.,Upon request to uicec@imibic.org,,YES,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,OTHER,,,,,,,2023,0.0
NCT03257267,,2017-07-26,2022-03-11,,2024-07-25,2017-08-17,2017-08-22,ACTUAL,2022-03-11,2022-04-06,ACTUAL,,,,2024-07-25,2024-07-29,ACTUAL,2017-09-05,ACTUAL,2017-09-05,2024-07,2024-07-31,2023-04-20,ACTUAL,2023-04-20,2021-03-15,ACTUAL,2021-03-15,,INTERVENTIONAL,,The FAS included all randomized participants.,Study of Cemiplimab in Adults With Cervical Cancer,"An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma",COMPLETED,,PHASE3,608.0,ACTUAL,Regeneron Pharmaceuticals,,2.0,,,f,,,,t,t,f,,,,,,"When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy",Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf,https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,INDUSTRY,,,,,,,2023,1.0
NCT04839315,,2021-04-05,,,2022-05-31,2021-04-07,2021-04-09,ACTUAL,,,,,,,2022-05-31,2022-06-03,ACTUAL,2021-02-15,ACTUAL,2021-02-15,2022-05,2022-05-31,2022-02-09,ACTUAL,2022-02-09,2022-02-09,ACTUAL,2022-02-09,,INTERVENTIONAL,,,COVID-19 Vaccination in Rheumatic Disease Patients,Immunological Consequences of COVID-19 Vaccination in Patients With Rheumatic Diseases,TERMINATED,,EARLY_PHASE1,58.0,ACTUAL,Mayo Clinic,,1.0,,Difficulty with enrollment,f,,,,f,t,f,,,,,,,,,,,2024-10-16 13:00:33.526766,2024-10-16 13:00:33.526766,OTHER,,,,,,,2022,0.0
NCT00493870,,2007-06-27,2020-09-16,,2023-02-28,2007-06-27,2007-06-28,ESTIMATED,2023-02-28,2023-03-02,ACTUAL,,,,2023-02-28,2023-03-02,ACTUAL,2007-05-29,ACTUAL,2007-05-29,2023-02,2023-02-28,2020-03-30,ACTUAL,2020-03-30,2015-05-31,ACTUAL,2015-05-31,,INTERVENTIONAL,,,TAC Versus TC for Adjuvant Breast Cancer,Phase III Trial of TC Versus TAC in HER2-Negative Early Stage Breast Cancer Patients,COMPLETED,,PHASE3,1961.0,ACTUAL,US Oncology Research,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,INDUSTRY,,,,,,,2020,1.0
NCT05086445,,2021-10-20,,,2022-11-25,2021-10-20,2021-10-21,ACTUAL,,,,,,,2022-11-25,2022-11-28,ACTUAL,2021-11-12,ACTUAL,2021-11-12,2022-11-01,2022-11-01,2022-09-05,ACTUAL,2022-09-05,2022-09-05,ACTUAL,2022-09-05,,INTERVENTIONAL,,,A Study of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus,"A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus",COMPLETED,,PHASE1,62.0,ACTUAL,Eli Lilly and Company,,4.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,INDUSTRY,,,,,,,2022,0.0
NCT02834975,,2016-07-13,2023-09-01,,2023-10-13,2016-07-13,2016-07-15,ESTIMATED,2023-10-13,2023-11-07,ACTUAL,,,,2023-10-13,2023-11-07,ACTUAL,2016-12-22,ACTUAL,2016-12-22,2023-10,2023-10-31,2022-12-01,ACTUAL,2022-12-01,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,,,"Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC).","Phase II Single Arm Study of Combination Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Ovarian, Fallopian Tube, or Peritoneal Carcinoma Receiving Neoadjuvant Chemotherapy",TERMINATED,,PHASE2,26.0,ACTUAL,University of Miami,,1.0,,Investigator left institution,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,OTHER,,,,,,,2022,0.0
NCT04443608,,2020-06-08,,,2023-08-29,2020-06-22,2020-06-23,ACTUAL,,,,,,,2023-08-29,2023-08-31,ACTUAL,2020-10-08,ACTUAL,2020-10-08,2023-04,2023-04-30,2023-06-03,ACTUAL,2023-06-03,2023-03-09,ACTUAL,2023-03-09,,INTERVENTIONAL,PLATINUM,,Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalemia Management,"A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 4 Study of the Efficacy & Safety of Patiromer for Oral Suspension in Combination With Standard of Care Treatment in ED Patients With Hyperkalemia",TERMINATED,,PHASE4,115.0,ACTUAL,Comprehensive Research Associates,,2.0,,Recruitment window ended,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,INDUSTRY,,,,,,,2023,0.0
NCT02319044,,2014-12-12,2018-03-26,,2020-09-11,2014-12-17,2014-12-18,ESTIMATED,2018-05-21,2018-06-19,ACTUAL,,,,2020-09-11,2020-09-29,ACTUAL,2015-04-15,ACTUAL,2015-04-15,2020-09,2020-09-30,2020-07-06,ACTUAL,2020-07-06,2016-09-26,ACTUAL,2016-09-26,,INTERVENTIONAL,,Full analysis set - all randomized patients,"Phase II Study of MEDI4736, Tremelimumab, and MEDI4736 in Combination w/ Tremelimumab Squamous Cell Carcinoma of the Head and Neck","A Phase II, Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination With Tremelimumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)",COMPLETED,,PHASE2,267.0,ACTUAL,AstraZeneca,,3.0,,,f,,,,t,,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,INDUSTRY,,,,,,,2020,1.0
NCT05075538,,2021-10-07,,,2024-01-12,2021-10-07,2021-10-12,ACTUAL,,,,,,,2024-01-12,2024-01-17,ACTUAL,2021-12-01,ACTUAL,2021-12-01,2023-02,2023-02-28,2024-01-08,ACTUAL,2024-01-08,2024-01-08,ACTUAL,2024-01-08,,INTERVENTIONAL,I-SPARC,,COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2,COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2,TERMINATED,,PHASE4,152.0,ACTUAL,Jules Bordet Institute,,,,The population as defined by the inclusion/exclusion criteria and the study logistics were leading to a poor recruitment over the past years.,f,,,,f,f,f,,,f,,,,,,,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,OTHER,,,,,,,2024,0.0
NCT05332483,,2022-04-10,,,2023-11-01,2022-04-10,2022-04-18,ACTUAL,,,,,,,2023-11-01,2023-11-03,ACTUAL,2022-07-05,ACTUAL,2022-07-05,2023-11,2023-11-30,2023-10-12,ACTUAL,2023-10-12,2023-10-12,ACTUAL,2023-10-12,,INTERVENTIONAL,MA-EEC,,Study of Megestrol Acetate in Grade 2 Endometrioid Endometrial Cancer,"The Effect of Megestrol Acetate on Grade 2 Endometrioid Endometrial Cancer in Patients Waiting for Definitive Surgery, a Prospective Trial",TERMINATED,,PHASE1,5.0,ACTUAL,Sunnybrook Health Sciences Centre,,1.0,,Slow enrollment,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,OTHER,,,,,,,2023,0.0
NCT04438174,,2020-06-16,2023-12-21,,2024-05-09,2020-06-16,2020-06-18,ACTUAL,2024-05-09,2024-06-07,ACTUAL,,,,2024-05-09,2024-06-07,ACTUAL,2022-08,ACTUAL,2022-08-31,2024-05,2024-05-31,2023-03,ACTUAL,2023-03-31,2023-03,ACTUAL,2023-03-31,,INTERVENTIONAL,,Enrollment was halted prematurely after enrolling one subject.,Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds,A Phase I/II Clinical Trial To Determine Safety And Feasibility Of Using An Acellular Amniotic Fluid Application To Expedite Healing In Chronic Wounds,TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,University of Utah,"Enrollment was halted prematurely after successful enrollment of one participant due to limited eligible participants. A single participant was enrolled in the treatment arm, hence we are unable to measure the safety and effectiveness of the intervention compared to standard care. We noted variation in wound size assessment for our single participant.",2.0,,Enrollment was halted prematurely after enrolling one participant due to difficulty finding eligible participants.,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,OTHER,,,,,,,2023,0.0
NCT03980249,,2019-05-01,,,2021-04-06,2019-06-05,2019-06-10,ACTUAL,,,,,,,2021-04-06,2021-04-12,ACTUAL,2020-09,ESTIMATED,2020-09-30,2021-04,2021-04-30,2022-06,ESTIMATED,2022-06-30,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells,A Pilot Study: Evaluating the Anti-Cancer Effects of Carvedilol With TTFields and Standard of Care in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,West Virginia University,,1.0,,No funding,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,OTHER,,,,,,,2022,0.0
NCT04562090,,2020-09-18,2023-03-04,,2023-04-19,2020-09-18,2020-09-24,ACTUAL,2023-03-04,2023-03-29,ACTUAL,,,,2023-04-19,2023-04-21,ACTUAL,2021-01-06,ACTUAL,2021-01-06,2023-04,2023-04-30,2022-03-30,ACTUAL,2022-03-30,2022-03-17,ACTUAL,2022-03-17,,INTERVENTIONAL,,All Randomized Set consisted of all participants who were randomized and had a randomization number.,A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder,"A Phase 4, Open-label, Randomized, Prospective, Interventional Post-authorization Efficacy and Safety Study of Mirabegron 50 mg and 25 mg for the Treatment of Overactive Bladder in Chinese Subjects",COMPLETED,,PHASE4,249.0,ACTUAL,Astellas Pharma Inc,,2.0,,,f,,,,f,t,f,,,t,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://www.clinicalstudydatarequest.com/,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.",2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,INDUSTRY,,,,,,,2022,1.0
NCT04264533,,2020-02-04,,,2020-10-08,2020-02-08,2020-02-11,ACTUAL,,,,,,,2020-10-08,2020-10-12,ACTUAL,2020-02-14,ACTUAL,2020-02-14,2020-10,2020-10-31,2020-03-29,ACTUAL,2020-03-29,2020-03-02,ACTUAL,2020-03-02,,INTERVENTIONAL,,,Vitamin C Infusion for the Treatment of Severe 2019-nCoV Infected Pneumonia,Vitamin C Infusion for the Treatment of Severe 2019-nCoV Infected Pneumonia: a Prospective Randomized Clinical Trial,TERMINATED,,PHASE2,56.0,ACTUAL,Zhongnan Hospital,,2.0,,"the study was started in the second half of the outbreak, and the number of qualifying COVID-19 patients decreased with the control of the epidemic so that we had to stop our trial before reaching the predefined sample size.",f,,,,,f,f,,,,,,,,,NO,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,OTHER,,,,,,,2020,0.0
NCT04041284,,2019-07-31,2023-08-23,,2023-09-29,2019-07-31,2019-08-01,ACTUAL,2023-09-29,2023-10-02,ACTUAL,,,,2023-09-29,2023-10-02,ACTUAL,2019-09-13,ACTUAL,2019-09-13,2023-09,2023-09-30,2022-08-31,ACTUAL,2022-08-31,2022-08-31,ACTUAL,2022-08-31,,INTERVENTIONAL,,The intent-to-treat (ITT) analysis set included all randomized participants.,A Study to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Followed by an Open-Label Extension to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder",COMPLETED,,PHASE4,353.0,ACTUAL,"Teva Branded Pharmaceutical Products R&D, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.",2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,INDUSTRY,,,,,,,2022,1.0
NCT03524261,,2018-05-02,,,2020-10-13,2018-05-02,2018-05-14,ACTUAL,,,,,,,2020-10-13,2020-10-19,ACTUAL,2019-05-20,ACTUAL,2019-05-20,2020-05,2020-05-31,2020-07-05,ACTUAL,2020-07-05,2020-04-05,ACTUAL,2020-04-05,,INTERVENTIONAL,,,Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Breast Cancer,Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Breast Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Fuda Cancer Hospital, Guangzhou",,3.0,,No participants enrolled,f,,,,t,f,f,,,,,,,,,,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,OTHER,,,,,,,2020,0.0
NCT03524339,,2018-04-10,2021-10-08,,2021-10-08,2018-05-02,2018-05-14,ACTUAL,2021-10-08,2021-11-08,ACTUAL,,,,2021-10-08,2021-11-08,ACTUAL,2018-08-01,ACTUAL,2018-08-01,2021-10,2021-10-31,2020-06-09,ACTUAL,2020-06-09,2020-06-09,ACTUAL,2020-06-09,,INTERVENTIONAL,,,Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery,Perioperative Administration of Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery,COMPLETED,,PHASE2/PHASE3,132.0,ACTUAL,University Hospitals Cleveland Medical Center,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,OTHER,,,,,,,2020,1.0
NCT03403205,,2017-12-19,2023-09-13,2022-01-20,2024-06-14,2018-01-10,2018-01-18,ACTUAL,2023-09-13,2023-10-10,ACTUAL,2022-01-20,2022-01-25,ACTUAL,2024-06-14,2024-06-17,ACTUAL,2018-02-22,ACTUAL,2018-02-22,2024-06,2024-06-30,2023-06-30,ACTUAL,2023-06-30,2023-06-30,ACTUAL,2023-06-30,,INTERVENTIONAL,,The Full Analysis Set included all randomized participants who received at least 1 dose of randomized treatment.~The Extension Analysis Set included all participants who entered the Extension Period and received at least 1 dose of ALXN1840 in the Extension Period. This included the participants who rolled over from Study WTX101-201.,Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Participants With Wilson Disease,"A Phase 3, Randomized, Rater-Blinded, Multi-Center Study to Evaluate the Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Patients With Wilson Disease Aged 12 Years and Older, With an Extension Period of up to 60 Months",TERMINATED,,PHASE3,214.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,2.0,,Sponsor decision to terminate the program,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 03:57:57.026788,2024-10-16 03:57:57.026788,INDUSTRY,,,,,,,2023,0.0
NCT04526821,,2020-08-21,,,2021-12-01,2020-08-21,2020-08-26,ACTUAL,,,,,,,2021-12-01,2021-12-09,ACTUAL,2020-10-17,ACTUAL,2020-10-17,2020-08,2020-08-31,2021-02-10,ACTUAL,2021-02-10,2021-02-10,ACTUAL,2021-02-10,,INTERVENTIONAL,LF-COVID,,Lactoferrin for Prevention of COVID-19 in Health Care Workers,"Bovine Lactoferrin for the Prevention of COVID-19 Infection in Physicians and Nurses in Hospitals in Lima, Peru: a Double Blinded Randomized Clinical Trial (LF-COVID)",TERMINATED,,PHASE2,209.0,ACTUAL,Universidad Peruana Cayetano Heredia,,2.0,,The study was interrupted due to the arrival and distribution of the vaccine to hospital workers in Peru,f,,,,t,f,f,,,,,,"Immediately following publication of the study,",Contact the study PI ( Theresa.ochoa@upch.pe),,YES,"Individual participant data collected during the trial, after deidentification, will be shared with researchers who provide a methodological sound study protocol previously approved by an independent ethics committee.",2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,OTHER,,,,,,,2021,0.0
NCT03742037,,2018-11-12,2023-08-07,2022-07-22,2023-09-20,2018-11-12,2018-11-15,ACTUAL,2023-09-20,2023-09-22,ACTUAL,,2023-09-22,ACTUAL,2023-09-20,2023-09-22,ACTUAL,2018-12-21,ACTUAL,2018-12-21,2023-09,2023-09-30,2022-08-25,ACTUAL,2022-08-25,2021-08-31,ACTUAL,2021-08-31,,INTERVENTIONAL,,,Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus,"A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE)",COMPLETED,,PHASE2,427.0,ACTUAL,Idorsia Pharmaceuticals Ltd.,,7.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 04:04:33.270448,2024-10-16 04:04:33.270448,INDUSTRY,,,,,,,2022,1.0
NCT04171388,,2019-10-09,,,2020-08-13,2019-11-19,2019-11-20,ACTUAL,,,,,,,2020-08-13,2020-08-17,ACTUAL,2020-03-01,ESTIMATED,2020-03-01,2020-08,2020-08-31,2021-11-30,ESTIMATED,2021-11-30,2021-05-28,ESTIMATED,2021-05-28,,INTERVENTIONAL,ENAT,,Enhancing Nutrition and Antenatal Infection Treatment for Maternal and Child Health in Ethiopia,"Enhancing Nutrition and Antenatal Infection Treatment for Maternal and Child Health in Amhara Region, Ethiopia",WITHDRAWN,,PHASE4,0.0,ACTUAL,Brigham and Women's Hospital,,6.0,,Trial withdrawn due to COVID-19.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 13:00:33.526766,2024-10-16 13:00:33.526766,OTHER,,,,,,,2021,0.0
NCT03281044,,2017-09-04,,,2020-04-15,2017-09-12,2017-09-13,ACTUAL,,,,,,,2020-04-15,2020-04-16,ACTUAL,2018-10-24,ACTUAL,2018-10-24,2020-04,2020-04-30,2020-03-16,ACTUAL,2020-03-16,2020-03-16,ACTUAL,2020-03-16,,INTERVENTIONAL,,,Fecal Microbiota Transplantation in Depression,"Oral Frozen Fecal Microbiota Transplantation (FMT) Capsules for Depression: a Double-blind, Placebo-controlled, Randomized Parallel Group Study",TERMINATED,,PHASE2,4.0,ACTUAL,Psychiatric Hospital of the University of Basel,,2.0,,"Although not observed in our patients (4 enrolled), SAEs have been reported in other patients receiving the same product.",f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,OTHER,,,,,,,2020,0.0
NCT03678480,,2018-09-18,,,2021-02-10,2018-09-18,2018-09-19,ACTUAL,,,,,,,2021-02-10,2021-02-15,ACTUAL,2021-03-01,ESTIMATED,2021-03-01,2020-07,2020-07-31,2021-11-04,ESTIMATED,2021-11-04,2021-10-04,ESTIMATED,2021-10-04,,INTERVENTIONAL,,,A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC),"A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)",WITHDRAWN,,PHASE2,0.0,ACTUAL,HighTide Biopharma Pty Ltd,,2.0,,Corporate decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 04:04:33.270448,2024-10-16 04:04:33.270448,INDUSTRY,,,,,,,2021,0.0
NCT04270929,,2020-01-16,,,2021-05-27,2020-02-12,2020-02-17,ACTUAL,,,,,,,2021-05-27,2021-06-01,ACTUAL,2019-12-23,ACTUAL,2019-12-23,2021-05,2021-05-31,2021-05-04,ACTUAL,2021-05-04,2021-05-04,ACTUAL,2021-05-04,,INTERVENTIONAL,PANC-001,,Pressure Enabled Drug Delivery By Pancreatic Retrograde Venous Infusion For Advanced Pancreatic Carcinoma,Pressure Enabled Drug Delivery By Pancreatic Retrograde Venous Infusion For Advanced Pancreatic Carcinoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,Roger Williams Medical Center,,1.0,,Insufficient accrual rate,f,,,,,t,t,,,f,,,,,,NO,,2024-10-16 04:04:33.270448,2024-10-16 04:04:33.270448,OTHER,,,,,,,2021,0.0
NCT04648319,,2020-11-11,,,2022-02-07,2020-11-23,2020-12-01,ACTUAL,,,,,,,2022-02-07,2022-02-23,ACTUAL,2021-04-15,ACTUAL,2021-04-15,2020-11,2020-11-30,2022-01-17,ACTUAL,2022-01-17,2022-01-17,ACTUAL,2022-01-17,,INTERVENTIONAL,,,A Study of BMS-936558 With SBRT After Induction Chemotherapy in Cholangiocarcinoma,A Pilot Study of BMS-936558 With Stereotactic Ablative Radiation Therapy After Induction Chemotherapy in Cholangiocarcinoma,TERMINATED,,PHASE2,1.0,ACTUAL,American University of Beirut Medical Center,,1.0,,pharma company decision to withdraw the financial and IMP support,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,OTHER,,,,,,,2022,0.0
NCT05162066,,2021-11-26,2024-04-08,,2024-04-08,2021-12-16,2021-12-17,ACTUAL,2024-04-08,2024-05-02,ACTUAL,,,,2024-04-08,2024-05-02,ACTUAL,2022-02-18,ACTUAL,2022-02-18,2024-04,2024-04-30,2022-09-23,ACTUAL,2022-09-23,2022-09-23,ACTUAL,2022-09-23,,INTERVENTIONAL,RENEW,Safety population included all participants who received at least one dose of the study drug.,"Study to Evaluate the Safety, Tolerability of BCX9930 in Participants With Either Complement 3 Glomerulopathy (C3G), Immunoglobulin A Nephropathy (IgAN), or Primary Membranous Nephropathy (PMN)","An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects With Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy",TERMINATED,,PHASE2,2.0,ACTUAL,BioCryst Pharmaceuticals,"The sponsor decided to prematurely terminate the study due to changes in the competitive landscape. Due to low enrolment in the study (N=2) and early termination of both participants, very limited data were available for analyses. Therefore, only key efficacy endpoints (24-hour uPCR, 24-hour urine protein excretion, and eGFR) and safety were analyzed and reported.",3.0,,Sponsor Decision,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 04:04:33.270448,2024-10-16 04:04:33.270448,INDUSTRY,,,,,,,2022,0.0
NCT04242368,,2020-01-21,,,2021-03-16,2020-01-23,2020-01-27,ACTUAL,,,,,,,2021-03-16,2021-03-18,ACTUAL,2020-07-01,ESTIMATED,2020-07-01,2021-03,2021-03-31,2021-07-01,ESTIMATED,2021-07-01,2021-07-01,ESTIMATED,2021-07-01,,INTERVENTIONAL,,,Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis,Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Stanford University,,2.0,,"COVID-19 pandemic, unable to recruit and conduct study procedures per state, local, and university policies.",f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 13:00:33.526766,2024-10-16 13:00:33.526766,OTHER,,,,,,,2021,0.0
NCT04133480,,2019-10-17,,,2022-08-31,2019-10-17,2019-10-21,ACTUAL,,,,,,,2022-08-31,2022-09-01,ACTUAL,2020-10,ESTIMATED,2020-10-31,2022-08,2022-08-31,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,EPI-COG,,Investigation of Cognitive Outcomes With Cannabidiol Oral Solution,An Open-Label Exploratory Investigation of Cognitive Outcomes With Cannabidiol Oral Solution (EPIDIOLEX®; GWP42003-P),WITHDRAWN,,PHASE4,0.0,ACTUAL,Jazz Pharmaceuticals,,1.0,,The decision to withdraw the study was based on pandemic-related concerns of conducting a Phase IV study requiring multiple clinic visits when medication is commercially available. The study was withdrawn before any participants were recruited.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 13:00:33.526766,2024-10-16 13:00:33.526766,INDUSTRY,,,,,,,2021,0.0
NCT04509466,,2020-08-06,,,2024-03-05,2020-08-09,2020-08-12,ACTUAL,,,,,,,2024-03-05,2024-03-07,ACTUAL,2020-09-15,ACTUAL,2020-09-15,2020-08,2020-08-31,2022-01-30,ACTUAL,2022-01-30,2022-01-30,ACTUAL,2022-01-30,,INTERVENTIONAL,,,Clinical Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL,"A Multicentre, Open-label, Single-arm, Phase I/II Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL",TERMINATED,,PHASE1/PHASE2,41.0,ACTUAL,"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.",,1.0,,The sponsor has adjusted its R\&D strategy.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 04:04:33.270448,2024-10-16 04:04:33.270448,INDUSTRY,,,,,,,2022,0.0
NCT04186156,,2019-07-17,,,2021-01-30,2019-12-03,2019-12-04,ACTUAL,,,,,,,2021-01-30,2021-02-03,ACTUAL,2020-03-05,ACTUAL,2020-03-05,2021-01,2021-01-31,2023-10,ESTIMATED,2023-10-31,2023-03,ESTIMATED,2023-03-31,,INTERVENTIONAL,,,A Study of Selective HDAC6 Inhibition With KA2507 in Advanced Biliary Tract Cancer,A Phase II Study of Selective HDAC6 Inhibition With KA2507 in Advanced Biliary Tract Cancer Previously Treated With Standard of Care Chemotherapy (ABC-11),WITHDRAWN,,PHASE2,0.0,ACTUAL,Karus Therapeutics Limited,,1.0,,Study not progressing,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:00:00.694225,2024-10-17 02:00:00.694225,INDUSTRY,,,,,,,2023,0.0
NCT05010096,,2021-07-01,,,2022-05-24,2021-08-10,2021-08-18,ACTUAL,,,,,,,2022-05-24,2022-05-27,ACTUAL,2022-03-22,ACTUAL,2022-03-22,2022-05,2022-05-31,2022-03-22,ACTUAL,2022-03-22,2022-03-22,ACTUAL,2022-03-22,,INTERVENTIONAL,,,BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors,Strategic Alliance: Phase 1b Trial of the Combination of the ATR Inhibitor BAY1895344 and PI3K Inhibitor Copanlisib in Molecularly Selected Patients With Advanced Solid Tumors (COPABAY),WITHDRAWN,,PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,2.0,,No participants Enrolled,,,,,f,t,f,,,,,,,,,,,2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,OTHER,,,,,,,2022,0.0
NCT04346329,,2020-04-10,,,2021-04-29,2020-04-13,2020-04-15,ACTUAL,,,,,,,2021-04-29,2021-05-05,ACTUAL,2020-03-30,ACTUAL,2020-03-30,2021-04,2021-04-30,2020-10-30,ACTUAL,2020-10-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,Chloroquine UN,,Immune Monitoring of Prophylactic Effect of Hydroxychloroquine in Healthcare Providers Highly Exposed to COVID-19,Immune Monitoring of Prophylactic Effect of Hydroxychloroquine in Healthcare Providers Highly Exposed to SARS-Cov-2,WITHDRAWN,,PHASE3,0.0,ACTUAL,Universidad Nacional de Colombia,,2.0,,The study did not get financed. Never got started.,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,OTHER,,,,,,,2020,0.0
NCT04388683,,2020-05-13,2022-03-21,,2022-04-12,2020-05-13,2020-05-14,ACTUAL,2022-04-12,2022-04-19,ACTUAL,,,,2022-04-12,2022-04-19,ACTUAL,2020-05-12,ACTUAL,2020-05-12,2022-04,2022-04-30,2020-11-23,ACTUAL,2020-11-23,2020-11-23,ACTUAL,2020-11-23,,INTERVENTIONAL,NO-COVID-19,,Inhaled Nitric Oxide for Preventing Progression in COVID-19,Prevention of COVID-19 Progression Through Early Administration of Inhaled Nitric Oxide.,TERMINATED,,PHASE2,10.0,ACTUAL,Tufts Medical Center,The study was terminated early by request of the company providing the iNO Drug. Our data set is small are analysis was effected by this.,2.0,,Bellerophon requested study to be stopped.,f,,,,t,t,f,,,,,,,,,NO,Data from this pilot study will be used to plan future a larger randomized controlled outcome trial.,2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,OTHER,,,,,,,2020,0.0
NCT04971005,,2020-08-12,,,2022-03-01,2021-07-20,2021-07-21,ACTUAL,,,,,,,2022-03-01,2022-03-16,ACTUAL,2021-08-27,ACTUAL,2021-08-27,2022-03,2022-03-31,2022-02-04,ACTUAL,2022-02-04,2022-02-04,ACTUAL,2022-02-04,,INTERVENTIONAL,COAST,,Ocrelizumab or Alemtuzumab Compared With Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis - a Phase-2 Randomised Controlled Trial,A Randomised Controlled Trial to Compare Ocrelizumab or Alemtuzumab With Autologous Hematopoietic Stem Cell Transplantation (aHSCT) in High Inflammatory Multiple Sclerosis (COAST),TERMINATED,,PHASE2,1.0,ACTUAL,Universitätsklinikum Hamburg-Eppendorf,,2.0,,Lack of recruitment due to low acceptance of the control arm.,f,,,,t,f,f,,,,,,,,,,,2024-10-16 04:04:33.270448,2024-10-16 04:04:33.270448,OTHER,,,,,,,2022,0.0
NCT03400852,,2018-01-09,2021-02-02,,2021-02-19,2018-01-09,2018-01-17,ACTUAL,2021-02-02,2021-02-21,ACTUAL,,,,2021-02-19,2021-03-16,ACTUAL,2018-07-27,ACTUAL,2018-07-27,2021-02,2021-02-28,2020-02-25,ACTUAL,2020-02-25,2020-02-25,ACTUAL,2020-02-25,,INTERVENTIONAL,BRAVE,All participants enrolled into the study.,A Study to Assess the Efficacy and Safety of MNK-1411 in Duchenne Muscular Dystrophy,"A Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Participants 4 to 8 Years of Age With Duchenne Muscular Dystrophy",TERMINATED,,PHASE2,44.0,ACTUAL,Mallinckrodt,,3.0,,Slow enrollment,f,,,,t,t,f,,,,,,,,,NO,Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03400852) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.,2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,INDUSTRY,,,,,,,2020,0.0
NCT03810183,,2019-01-15,2021-01-04,,2021-10-07,2019-01-17,2019-01-18,ACTUAL,2021-01-04,2021-01-25,ACTUAL,,,,2021-10-07,2021-10-08,ACTUAL,2019-05-21,ACTUAL,2019-05-21,2021-10,2021-10-31,2020-01-16,ACTUAL,2020-01-16,2020-01-16,ACTUAL,2020-01-16,,INTERVENTIONAL,,,"A Proof-of-mechanism Study of Multiple, Oral Doses of Fevipiprant (QAW039) in COPD Patients With Eosinophilia","A Multi-center, Proof-of-mechanism Study of Multiple, Oral Doses of Fevipiprant (QAW039) in COPD Patients With Eosinophilia",TERMINATED,,PHASE2,9.0,ACTUAL,Novartis,,2.0,,Company decision,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2020,0.0
NCT05107115,,2021-10-27,,2024-07-18,2024-07-18,2021-10-27,2021-11-04,ACTUAL,,,,,2024-07-19,ACTUAL,2024-07-18,2024-07-19,ACTUAL,2021-11-24,ACTUAL,2021-11-24,2024-07,2024-07-31,2024-04-23,ACTUAL,2024-04-23,2023-07-19,ACTUAL,2023-07-19,,INTERVENTIONAL,RILECSU,,Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine,"A Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Phase 2 Study of Rilzabrutinib Followed by an Open-label Extension Phase in Patients With Moderate-to-severe Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment",COMPLETED,,PHASE2,161.0,ACTUAL,Sanofi,,4.0,,,f,,,,f,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2024,1.0
NCT04552704,,2020-09-10,2022-03-08,,2023-08-01,2020-09-10,2020-09-17,ACTUAL,2022-03-08,2022-04-04,ACTUAL,,,,2023-08-01,2023-08-02,ACTUAL,2020-10-30,ACTUAL,2020-10-30,2023-08,2023-08-31,2022-01-26,ACTUAL,2022-01-26,2021-02-03,ACTUAL,2021-02-03,,INTERVENTIONAL,,The study was terminated by the sponsor after 3 out of 6 patients enrolled in phase I study.,"CD24Fc for the Treatment of Immune Related Adverse Events in Patients With Advanced Solid Tumors, TIRAEC Study",Treatment of Immune Related Adverse Events With CD24Fc (TIRAEC),TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,"University of California, Davis",The study was terminated by the sponsor after 3 out of 6 patients enrolled in phase I study.,3.0,,Terminated early by the Sponsor due to business reason.,,,,,t,t,f,,,f,,,,,,,,2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,OTHER,,,,,,,2022,0.0
NCT04055883,,2019-08-12,,,2023-03-01,2019-08-12,2019-08-14,ACTUAL,,,,,,,2023-03-01,2023-03-03,ACTUAL,2019-08-26,ACTUAL,2019-08-26,2023-03,2023-03-31,2023-02-01,ACTUAL,2023-02-01,2023-02-01,ACTUAL,2023-02-01,,INTERVENTIONAL,DIP-CAVD,,Clinical Study to Evaluate Efficacy and Safety of DA-1229 in Patients With CAVD,"A Multicenter, Double-blind, Placebo-controlled, Stratified-randomized, Parallel, Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-1229 in Patients With Calcific Aortic Valve Disease",COMPLETED,,PHASE2,228.0,ACTUAL,"Dong-A ST Co., Ltd.",,3.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2023,0.0
NCT02792231,,2016-06-02,2020-09-18,2019-09-24,2021-10-21,2016-06-02,2016-06-07,ESTIMATED,2020-09-18,2020-10-19,ACTUAL,2019-09-24,2019-10-08,ACTUAL,2021-10-21,2021-11-22,ACTUAL,2016-08-26,ACTUAL,2016-08-26,2021-10,2021-10-31,2020-10-22,ACTUAL,2020-10-22,2019-07-10,ACTUAL,2019-07-10,,INTERVENTIONAL,ASCLEPIOS II,It was pre-specified in the protocol to combine the data from this study with study NCT02792218 (COMB157G2301) for some outcome measures. Please refer to NCT02792218 for Baseline information for participants from other study.,Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.,"A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis.",COMPLETED,,PHASE3,955.0,ACTUAL,Novartis,This study was not powered for the analysis of some secondary endpoints as a stand-alone study. It was pre-specified in the study protocol to combine the data with study COMB157G2301 to address these endpoints.,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,INDUSTRY,,,,,,,2020,1.0
NCT05268926,,2021-12-02,,,2024-04-15,2022-02-24,2022-03-07,ACTUAL,,,,,,,2024-04-15,2024-04-17,ACTUAL,2022-02-03,ACTUAL,2022-02-03,2024-04,2024-04-30,2023-02-02,ACTUAL,2023-02-02,2023-02-02,ACTUAL,2023-02-02,,INTERVENTIONAL,TIMOTHY,,TreatIng Microalbuminuria Over 24 Weeks in Subjects With or Without Type 2 Diabetes or HYpertension,TreatIng Microalbuminuria Over 24 Weeks in Subjects With or Without Type 2 Diabetes or HYpertension,TERMINATED,,PHASE2,9.0,ACTUAL,University Medical Center Groningen,,2.0,,"Due to a delayed start-up and delayed patient inclusion in combination with new available scientific data, continuation of the clinical study no longer serves a scientific purpose.",f,,,,t,f,f,,,f,,,,,,,,2024-10-16 04:04:33.270448,2024-10-16 04:04:33.270448,OTHER,,,,,,,2023,0.0
NCT03754244,,2018-11-23,,,2022-03-29,2018-11-23,2018-11-27,ACTUAL,,,,,,,2022-03-29,2022-04-07,ACTUAL,2020-09-24,ACTUAL,2020-09-24,2022-03,2022-03-31,2022-02-28,ACTUAL,2022-02-28,2022-02-28,ACTUAL,2022-02-28,,INTERVENTIONAL,,,A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics,A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics,TERMINATED,,PHASE1,1.0,ACTUAL,"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",,1.0,,"The enrolment task cannot be gotten within the planned time.It mainly includes patients with non-small cell lung cancer failed in standard treatment,with a short survival period.It is hard to obtain observational endpoints for bone-related events.",f,,,,,f,f,,,,,,,,,NO,,2024-10-16 04:04:33.270448,2024-10-16 04:04:33.270448,INDUSTRY,,,,,,,2022,0.0
NCT02721069,,2016-03-17,2021-11-15,,2022-01-27,2016-03-22,2016-03-28,ESTIMATED,2022-01-27,2022-01-31,ACTUAL,,,,2022-01-27,2022-01-31,ACTUAL,2016-04-11,ACTUAL,2016-04-11,2022-01,2022-01-31,2020-07-23,ACTUAL,2020-07-23,2020-06-17,ACTUAL,2020-06-17,,INTERVENTIONAL,,,Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects,"A 12-Month Open-Label, Repeat-Dose Safety Study of NRL-1 in Epilepsy Subjects (DIAZ.001.05)",COMPLETED,,PHASE3,175.0,ACTUAL,"Neurelis, Inc.",,1.0,,,f,,,,f,,,,,,,,,,,UNDECIDED,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2020,1.0
NCT01715285,,2012-10-24,2018-03-09,2017-11-20,2023-02-10,2012-10-24,2012-10-26,ESTIMATED,2018-03-09,2018-10-15,ACTUAL,2017-12-20,2017-12-21,ACTUAL,2023-02-10,2023-03-13,ACTUAL,2013-02-12,ACTUAL,2013-02-12,2023-02,2023-02-28,2022-02-13,ACTUAL,2022-02-13,2016-10-31,ACTUAL,2016-10-31,,INTERVENTIONAL,,"Intent-to-Treat (ITT) analysis set included all participants randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received. .","A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)","A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)",COMPLETED,,PHASE3,1209.0,ACTUAL,"Janssen Research & Development, LLC",As per protocol the long-term extension (LTE) phase was planned but LTE phase is not included as part of this study hence no data was reported for LTE phase.,2.0,,,f,,,,t,,f,,,,,,,,,,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2022,1.0
NCT03104725,,2017-04-04,2021-02-19,,2021-11-01,2017-04-04,2017-04-07,ACTUAL,2021-04-29,2021-05-19,ACTUAL,,,,2021-11-01,2021-11-04,ACTUAL,2017-09-25,ACTUAL,2017-09-25,2020-03,2020-03-31,2020-02-27,ACTUAL,2020-02-27,2020-02-27,ACTUAL,2020-02-27,,INTERVENTIONAL,,,Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinson's Disease?,Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinson's Disease?,TERMINATED,,PHASE1,6.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,"Difficulty with recruitment and participant accrual due to study eligibility criteria and required study procedures (e.g., multiple lumbar punctures).",f,,,,,t,f,,,,,,,,,,,2024-10-16 04:04:33.270448,2024-10-16 04:04:33.270448,NIH,,,,,,,2020,0.0
NCT04738981,,2021-02-01,,,2023-05-31,2021-02-01,2021-02-04,ACTUAL,,,,,,,2023-05-31,2023-06-01,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2023-05,2023-05-31,2023-05-02,ACTUAL,2023-05-02,2022-05-30,ACTUAL,2022-05-30,,INTERVENTIONAL,,,Efficacy and Safety of UC-MSCs for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT,"Efficacy and Safety of UC-MSCS for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT: A Multicenter, Randomized, Open-label Trial",COMPLETED,,PHASE3,130.0,ACTUAL,Peking University People's Hospital,,2.0,,,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,OTHER,,,,,,,2023,1.0
NCT04941989,,2021-06-08,,,2022-03-24,2021-06-23,2021-06-28,ACTUAL,,,,,,,2022-03-24,2022-03-25,ACTUAL,2021-06-22,ACTUAL,2021-06-22,2022-03,2022-03-31,2021-11-23,ACTUAL,2021-11-23,2021-11-23,ACTUAL,2021-11-23,,INTERVENTIONAL,,,"A Study in Healthy Subjects to Assess the Safety, Tolerability and Pharmacokinetics of HTL0022562","A Phase 1, Randomised, Double-Blind, Placebo-Controlled, First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Subcutaneous HTL0022562 in Healthy Adult Subjects",TERMINATED,,PHASE1,33.0,ACTUAL,Nxera Pharma UK Limited,,2.0,,Early termination of study pending evaluation of emerging preclinical profile.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2021,0.0
NCT01725490,,2012-10-31,,,2021-09-16,2012-11-07,2012-11-12,ESTIMATED,,,,,,,2021-09-16,2021-09-20,ACTUAL,2013-02-15,ACTUAL,2013-02-15,2021-09,2021-09-30,2020-08-30,ACTUAL,2020-08-30,2020-08-30,ACTUAL,2020-08-30,,INTERVENTIONAL,,,The Chemopreventive Effect of Metformin in Patients With Familial Adenomatous Polyposis: Double Blinded Randomized Controlled Study,,COMPLETED,,PHASE2,34.0,ACTUAL,Yonsei University,,3.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,OTHER,,,,,,,2020,0.0
NCT03066154,,2016-09-23,,,2024-05-30,2017-02-22,2017-02-28,ACTUAL,,,,,,,2024-05-30,2024-06-03,ACTUAL,2016-09,ACTUAL,2016-09-30,2024-05,2024-05-31,2022-08,ACTUAL,2022-08-31,2022-02,ACTUAL,2022-02-28,,INTERVENTIONAL,DOP,,Oral Docetaxel (ModraDoc/r) in Combination With Hormonal Treatment and Radiation Therapy in High-risk Prostate Cancer,Weekly ModraDoc/r in Combination With Hormonal Treatment and High-dose Intensity-modulated Radiation Therapy in Patients With High-risk Early Stage Prostate Cancer,TERMINATED,,PHASE1,24.0,ACTUAL,The Netherlands Cancer Institute,,1.0,,low inclusion of patients and availability of the IP,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 13:00:33.526766,2024-10-16 13:00:33.526766,OTHER,,,,,,,2022,0.0
NCT04762186,,2021-02-11,,,2022-09-12,2021-02-18,2021-02-21,ACTUAL,,,,,,,2022-09-12,2022-09-15,ACTUAL,2021-12-08,ACTUAL,2021-12-08,2022-09,2022-09-30,2022-08-03,ACTUAL,2022-08-03,2022-08-03,ACTUAL,2022-08-03,,INTERVENTIONAL,ACT-COVID-19,,Viable Human SARS-CoV-2 Specific T Cell Transfer in Patients at Risk for Severe COVID-19,A Phase I/ Randomized Phase II Trial to Analyse Safety and Efficacy of Human SARS-CoV-2-specific T Lymphocyte Transfer in Patients With COVID-19 in Need of Treatment or at Risk of Severe COVID-19,TERMINATED,,PHASE1,1.0,ACTUAL,Universitätsklinikum Köln,,1.0,,poor recruitment,f,,,,t,f,f,,,,,,,,,,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,OTHER,,,,,,,2022,0.0
NCT04329195,,2020-03-28,,,2021-04-08,2020-03-28,2020-04-01,ACTUAL,,,,,,,2021-04-08,2021-04-09,ACTUAL,2020-04-09,ACTUAL,2020-04-09,2021-04,2021-04-30,2021-01-09,ACTUAL,2021-01-09,2020-12-09,ACTUAL,2020-12-09,,INTERVENTIONAL,ACORES-2,,ACE Inhibitors or ARBs Discontinuation in Context of COVID-19 Pandemic,ACE Inhibitors or ARBs Discontinuation for Clinical Outcome Risk Reduction in Patients Hospitalized for the Endemic Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection: the Randomized ACORES-2 Study,TERMINATED,,PHASE3,44.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,insufficient recrutment,f,,,,t,f,f,,,,,,,,,,,2024-10-16 04:04:33.270448,2024-10-16 04:04:33.270448,OTHER,,,,,,,2021,0.0
NCT04499235,,2020-07-31,2022-03-30,,2023-09-01,2020-07-31,2020-08-05,ACTUAL,2023-09-01,2023-09-14,ACTUAL,,,,2023-09-01,2023-09-14,ACTUAL,2020-01-30,ACTUAL,2020-01-30,2023-09,2023-09-30,2021-04-14,ACTUAL,2021-04-14,2021-03-29,ACTUAL,2021-03-29,,INTERVENTIONAL,,,A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid,"Double-Blind, Randomized, Placebo-Controlled Trial of AKST4290 for Adjunctive Treatment of Mild to Moderate Bullous Pemphigoid",TERMINATED,,PHASE2,6.0,ACTUAL,"Alkahest, Inc.",,2.0,,"The study was prematurely terminated by the Sponsor due to operational challenges stemming from the coronavirus disease 2019 (COVID-19) pandemic, treatment limitations, rarity of the disease, and drug supply considerations.",f,,,,t,f,f,,,t,,,,,,NO,,2024-10-16 13:00:33.526766,2024-10-16 13:00:33.526766,INDUSTRY,,,,,,,2021,0.0
NCT04206865,,2019-12-11,,,2020-10-01,2019-12-18,2019-12-20,ACTUAL,,,,,,,2020-10-01,2020-10-05,ACTUAL,2019-11-25,ACTUAL,2019-11-25,2020-10,2020-10-31,2020-09-10,ACTUAL,2020-09-10,2020-09-10,ACTUAL,2020-09-10,,INTERVENTIONAL,PARAVLO-HF,,Comparison of ARNI to Alternate Oral Vasodilator Therapies in Patients With Low Cardiac Output,Prospective Comparison of ARNI to Alternate Oral Vasodilator Therapies to Determine the Hemodynamic Profile and Relative Tolerability of (ARNIs) in Patients With Decompensated Heart Failure and Low Cardiac Output,WITHDRAWN,,PHASE4,0.0,ACTUAL,The Cleveland Clinic,,2.0,,New study initiated,f,,,,f,t,f,,,t,,,,,,,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,OTHER,,,,,,,2020,0.0
NCT04390243,,2020-05-12,2023-12-12,,2024-05-03,2020-05-12,2020-05-15,ACTUAL,2023-12-29,2024-01-23,ACTUAL,,,,2024-05-03,2024-05-06,ACTUAL,2020-11-16,ACTUAL,2020-11-16,2023-09,2023-09-30,2023-11-01,ACTUAL,2023-11-01,2023-11-01,ACTUAL,2023-11-01,,INTERVENTIONAL,,,Binimetinib and Encorafenib for the Treatment of Pancreatic Cancer in Patients With a Somatic BRAF V600E Mutation,BrafPanc: A Phase II Trial of Binimetinib in Combination With Encorafenib in Patients With Pancreatic Malignancies and a Somatic BRAFV600E Mutation,TERMINATED,,PHASE2,6.0,ACTUAL,Academic and Community Cancer Research United,,1.0,,Slow accrual,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,OTHER,,,,,,,2023,0.0
NCT02913482,,2016-09-21,2020-11-10,,2024-08-01,2016-09-22,2016-09-23,ESTIMATED,2020-12-14,2021-01-08,ACTUAL,,,,2024-08-01,2024-08-07,ACTUAL,2016-12-23,ACTUAL,2016-12-23,2024-07,2024-07-31,2023-12-22,ACTUAL,2023-12-22,2019-11-14,ACTUAL,2019-11-14,,INTERVENTIONAL,FIREFISH,,"Investigate Safety, Tolerability, PK, PD and Efficacy of Risdiplam (RO7034067) in Infants With Type1 Spinal Muscular Atrophy","A Two Part Seamless, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Infants With Type 1 Spinal Muscular Atrophy",COMPLETED,,PHASE2,62.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,INDUSTRY,,,,,,,2023,1.0
NCT03394937,,2017-11-28,,,2021-06-16,2018-01-03,2018-01-09,ACTUAL,,,,,,,2021-06-16,2021-06-21,ACTUAL,2017-06-27,ACTUAL,2017-06-27,2020-09,2020-09-30,2021-01-29,ACTUAL,2021-01-29,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Safety of Intranodal ECI-006 in Melanoma Patients,"Study to Assess the Safety and Tolerability of ECI-006 mRNA Immunotherapy by Intranodal Administration in Melanoma: (1) Following Surgical Resection, and (2) in Patients With Stable Disease After Standard of Care Immunotherapy Treatment",TERMINATED,,PHASE1,21.0,ACTUAL,eTheRNA immunotherapies,,4.0,,Expiry of study medication,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2021,0.0
NCT04115384,,2019-10-02,2023-06-14,,2023-10-25,2019-10-02,2019-10-04,ACTUAL,2023-06-14,2023-07-06,ACTUAL,,,,2023-10-25,2023-10-27,ACTUAL,2019-09-09,ACTUAL,2019-09-09,2023-04,2023-04-30,2023-05-15,ACTUAL,2023-05-15,2020-02-26,ACTUAL,2020-02-26,,INTERVENTIONAL,,,Intranasal Insulin in Frontotemporal Dementia (FTD),A Single Center Feasibility Study of Intranasal Insulin in Frontotemporal Dementia NIFT-D,TERMINATED,,PHASE2,3.0,ACTUAL,HealthPartners Institute,,1.0,,COVID - unable to restart after restrictions were lifted,f,,,,t,t,f,,,,,,,,,,,2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,OTHER,,,,,,,2023,0.0
NCT03965494,,2019-05-24,,,2024-02-07,2019-05-24,2019-05-29,ACTUAL,,,,,,,2024-02-07,2024-02-08,ACTUAL,2020-01-02,ACTUAL,2020-01-02,2024-02,2024-02-29,2023-10-31,ACTUAL,2023-10-31,2023-10-31,ACTUAL,2023-10-31,,INTERVENTIONAL,,,AXL Inhibitor BGB324 in Treating Participants With Recurrent Glioblastoma Undergoing Surgery,Pilot Surgical PK Study of BGB324 in Recurrent Glioblastoma Patients,TERMINATED,,EARLY_PHASE1,10.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,2.0,,NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer - official close date is 10/31/23,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,OTHER,,,,,,,2023,0.0
NCT04393727,,2020-05-16,,,2020-11-09,2020-05-16,2020-05-19,ACTUAL,,,,,,,2020-11-09,2020-11-12,ACTUAL,2020-05-01,ACTUAL,2020-05-01,2020-11,2020-11-30,2020-09-30,ACTUAL,2020-09-30,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,TSUNAMI,,Transfusion of Convalescent Plasma for the Early Treatment of Patients With COVID-19,Transfusion of Convalescent Plasma for the Early Treatment of pneumonIa Due to SARSCoV2: a Multicenter Open Label Randomized Control Trial,TERMINATED,,PHASE2,1.0,ACTUAL,"Azienda Ospedaliero, Universitaria Pisana",,2.0,,Study was stopped because the Promoter was changed and a new study on convalescent plasma promoted by AIFA was started in Italy.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,OTHER,,,,,,,2020,0.0
NCT02435849,,2015-04-16,2021-09-23,,2024-01-18,2015-05-01,2015-05-06,ESTIMATED,2021-10-22,2021-11-22,ACTUAL,,,,2024-01-18,2024-02-13,ACTUAL,2015-04-08,ACTUAL,2015-04-08,2023-12,2023-12-31,2022-11-17,ACTUAL,2022-11-17,2020-01-21,ACTUAL,2020-01-21,,INTERVENTIONAL,ELIANA,Full Analysis Set (FAS): The Full analysis set comprised all patients who received infusion of tisagenlecleucel.,Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients,"A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Pediatric Patients With Relapsed and Refractory B-cell Acute Lymphoblastic Leukemia",COMPLETED,,PHASE2,80.0,ACTUAL,Novartis,,1.0,,,f,,,,t,t,f,,,,,,,,https://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 04:04:33.270448,2024-10-16 04:04:33.270448,INDUSTRY,,,,,,,2022,1.0
NCT03312738,,2017-09-15,2023-04-17,,2023-04-17,2017-10-12,2017-10-18,ACTUAL,2023-04-17,2024-01-23,ACTUAL,,,,2023-04-17,2024-01-23,ACTUAL,2017-09-15,ACTUAL,2017-09-15,2023-04,2023-04-30,2022-04-25,ACTUAL,2022-04-25,2022-04-25,ACTUAL,2022-04-25,,INTERVENTIONAL,BOLERO-5,,"A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor","A Randomized, Double-blind, Placebo Controlled, Phase II Study of Everolimus in Combination With Exemestane in the Treatment of Chinese Postmenopausal Women With Estrogen Receptor Positive, HER-2 Negative, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Prior Letrozole or Anastrozole",COMPLETED,,PHASE2,159.0,ACTUAL,Novartis,,2.0,,,f,,,,f,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2022,1.0
NCT03504917,,2018-04-12,2021-03-02,,2021-10-26,2018-04-12,2018-04-20,ACTUAL,2021-04-14,2021-05-07,ACTUAL,,,,2021-10-26,2021-10-27,ACTUAL,2018-08-08,ACTUAL,2018-08-08,2021-10,2021-10-31,2020-07-01,ACTUAL,2020-07-01,2020-03-04,ACTUAL,2020-03-04,,INTERVENTIONAL,,,A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension,"A Phase III, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension",TERMINATED,,PHASE3,322.0,ACTUAL,Hoffmann-La Roche,,2.0,,A futility analysis assessed that the study is highly unlikely to meet the pre-defined primary objective of the study. No new safety concerns were identified.,f,,,,t,t,f,,,,,,,,,,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2020,0.0
NCT04474483,,2020-05-15,2023-10-19,,2024-01-15,2020-07-15,2020-07-16,ACTUAL,2024-01-15,2024-02-07,ACTUAL,,,,2024-01-15,2024-02-07,ACTUAL,2020-11-06,ACTUAL,2020-11-06,2024-01,2024-01-31,2022-07-22,ACTUAL,2022-07-22,2022-07-22,ACTUAL,2022-07-22,,INTERVENTIONAL,COVID-19,,Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19,A Pilot Placebo-controlled Randomized Double-blind Trial of Melatonin in Outpatients With COVID-19 Infection,TERMINATED,,PHASE2,8.0,ACTUAL,State University of New York at Buffalo,,2.0,,difficult recruitment and complete first visit in person during thne hight of tne pandemic and later not enough subjects,f,,,,,t,f,,,,,,,,,,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,OTHER,,,,,,,2022,0.0
NCT02620280,,2015-11-03,,,2024-03-05,2015-11-30,2015-12-02,ESTIMATED,,,,,,,2024-03-05,2024-03-06,ACTUAL,2016-04,,2016-04-30,2024-03,2024-03-31,2024-01-07,ACTUAL,2024-01-07,2024-01,ACTUAL,2024-01-31,,INTERVENTIONAL,NeoTRIPaPDL1,,Neoadjuvant Therapy in TRIPle Negative Breast Cancer With antiPDL1,Neo-Adjuvant Study With the PDL1-directed Antibody in Triple Negative Locally Advanced Breast Cancer Undergoing Treatment With Nab-paclitaxel and Carboplatin,COMPLETED,,PHASE3,278.0,ACTUAL,Fondazione Michelangelo,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,OTHER,,,,,,,2024,0.0
NCT04958967,,2021-07-05,,,2021-10-17,2021-07-09,2021-07-12,ACTUAL,,,,,,,2021-10-17,2021-10-25,ACTUAL,2021-10-01,ESTIMATED,2021-10-01,2021-07,2021-07-31,2022-08-01,ESTIMATED,2022-08-01,2022-05-01,ESTIMATED,2022-05-01,,INTERVENTIONAL,,,Phase Ib Study of FURMONERTINIB in Patients With NSCLC Having Exon 20 Insertion Mutation,"A Phase Ib Open-Label, Randomization Multi-Center Study to Evaluate Efficacy And Safety of FURMONERTINIB MESILATE IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER HARBOURING EGFR EXON 20 INSERTION MUTATION",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Allist Pharmaceuticals, Inc.",,2.0,,The protocol need to review,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2022,0.0
NCT03126760,,2017-04-04,2021-05-10,,2021-06-14,2017-04-19,2017-04-24,ACTUAL,2021-05-10,2021-06-03,ACTUAL,,,,2021-06-14,2021-07-12,ACTUAL,2017-05-22,ACTUAL,2017-05-22,2021-06,2021-06-30,2020-07-14,ACTUAL,2020-07-14,2020-07-14,ACTUAL,2020-07-14,,INTERVENTIONAL,OPTIONS,All participants,Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS),"A Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of Acthar® in Subjects With Relapsing-remitting Multiple Sclerosis",TERMINATED,,PHASE4,35.0,ACTUAL,Mallinckrodt,The study was terminated early by sponsor decision because of recruitment difficulties and the impact of the COVID-19 pandemic. The planned analyses did not change except that the total sample size was reduced. Inferential statistics were not performed. Results are nominal because the sample size did not reach that specified in the protocol.,2.0,,Recruitment difficulties and COVID-19 logistical challenges; no safety concerns,f,,,,,t,f,,,f,,,,,,NO,Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03126760) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.,2024-10-16 04:04:33.270448,2024-10-16 04:04:33.270448,INDUSTRY,,,,,,,2020,0.0
NCT02814175,,2016-06-21,2020-09-15,,2020-10-30,2016-06-24,2016-06-27,ESTIMATED,2020-10-30,2020-11-23,ACTUAL,,,,2020-10-30,2020-11-23,ACTUAL,2016-08-05,ACTUAL,2016-08-05,2020-10,2020-10-31,2020-03-19,ACTUAL,2020-03-19,2019-09-23,ACTUAL,2019-09-23,,INTERVENTIONAL,CONTROL,The Intent-To-Treat Part 1 (ITT Part 1) population comprises all participants who were randomized and received at least one dose of the study medication during Part 1.,A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL),A Phase 4 Open-label Randomized Controlled Study COmparing the Effectiveness of Adalimumab iNTROduction and Methotrexate Dose escaLation in Subjects With Psoriatic Arthritis (CONTROL),COMPLETED,,PHASE4,246.0,ACTUAL,AbbVie,,6.0,,,f,,,,f,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,INDUSTRY,,,,,,,2020,1.0
NCT04513548,,2020-08-07,,,2024-06-14,2020-08-12,2020-08-14,ACTUAL,,,,,,,2024-06-14,2024-06-18,ACTUAL,2020-08-05,ACTUAL,2020-08-05,2024-06,2024-06-30,2022-07-19,ACTUAL,2022-07-19,2022-07-19,ACTUAL,2022-07-19,,INTERVENTIONAL,MASTER,,Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria,"A Two-part Exploratory Study Combining a Pilot Study in Healthy Subjects and Chronic Spontaneous Urticaria Patients (Part 1) and a Randomized, Subject, Investigator and Sponsor-blinded, Placebo Controlled, Study (Part 2) to Assess the MechAniSm of acTion of ligElizumab (QGE031) in Patients With Chronic uRticaria (MASTER)",TERMINATED,,PHASE1,11.0,ACTUAL,Novartis,,2.0,,Company decision,f,,,,f,f,f,,,,,,,,,NO,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,INDUSTRY,,,,,,,2022,0.0
NCT04540120,,2020-08-13,,,2023-04-11,2020-09-03,2020-09-07,ACTUAL,,,,,,,2023-04-11,2023-04-13,ACTUAL,2020-09-24,ACTUAL,2020-09-24,2023-04,2023-04-30,2022-07-28,ACTUAL,2022-07-28,2022-07-28,ACTUAL,2022-07-28,,INTERVENTIONAL,,,Safety and Efficacy of Dapansutrile for Treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release Syndrome,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Orally Administered Dapansutrile Capsules for the Treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release Syndrome",TERMINATED,,PHASE2,49.0,ACTUAL,Olatec Therapeutics LLC,,2.0,,Terminated due to the treatment environment for COVID-19 evolving with the pervasiveness of vaccinations and other therapeutic modalities in mitigating against severe infection that has eliminated a viable patient population for study enrollment.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 13:00:33.526766,2024-10-16 13:00:33.526766,INDUSTRY,,,,,,,2022,0.0
NCT02997956,,2016-12-16,,,2017-04-21,2016-12-19,2016-12-20,ESTIMATED,,,,,,,2017-04-21,2017-04-25,ACTUAL,2017-07,ESTIMATED,2017-07-31,2017-04,2017-04-30,2022-07,ESTIMATED,2022-07-31,2020-07,ESTIMATED,2020-07-31,,INTERVENTIONAL,,,Study of Tocilizumab in Patients With Hepatocellular Carcinoma (HCC) Undergoing Transarterial Chemoembolization (TACE),Phase IB/II Study of Tocilizumab in Patients With Hepatocellular Carcinoma (HCC) Undergoing Transarterial Chemoembolization (TACE),WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Michigan Rogel Cancer Center,,1.0,,funding issues,f,,,,t,t,f,,,,,,,,,,,2024-10-16 13:00:33.526766,2024-10-16 13:00:33.526766,OTHER,,,,,,,2022,0.0
NCT05545072,,2022-08-31,,,2024-07-17,2022-09-15,2022-09-19,ACTUAL,,,,,,,2024-07-17,2024-07-18,ACTUAL,2023-10-26,ACTUAL,2023-10-26,2024-07,2024-07-31,2024-07-10,ACTUAL,2024-07-10,2024-07-10,ACTUAL,2024-07-10,,INTERVENTIONAL,ADAPT,,Add-on Dupilumab for AFRS as Postoperative Therapy (ADAPT),"A Randomized, 52-week Treatment Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week After Endoscopic Sinus Surgery in Patients With Allergic Fungal Rhinosinusitis (AFRS) on a Background Therapy With Intranasal Corticosteroid Spray",TERMINATED,,PHASE3,5.0,ACTUAL,Emory University,,2.0,,The study was terminated due to funding ending.,f,,,,t,t,f,,,,,,The investigators will share de-identified data beginning 3 months and ending 5 years following article publication.,"Proposals should be directed to joshua.levy2@emory.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third-party website.",,YES,"The investigators plan to share individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices)",2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,OTHER,,,,,,,2024,0.0
NCT03768219,,2018-11-30,,,2021-05-15,2018-12-06,2018-12-07,ACTUAL,,,,,,,2021-05-15,2021-05-19,ACTUAL,2019-03-18,ACTUAL,2019-03-18,2021-05,2021-05-31,2020-06-30,ACTUAL,2020-06-30,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,"Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis","Phase 1 Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis",TERMINATED,,PHASE1,85.0,ACTUAL,Aptevo Therapeutics,,14.0,,Business decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 13:00:33.526766,2024-10-16 13:00:33.526766,INDUSTRY,,,,,,,2020,0.0
NCT04112303,,2019-09-30,2022-03-23,,2022-03-23,2019-09-30,2019-10-02,ACTUAL,2022-03-23,2022-04-20,ACTUAL,,,,2022-03-23,2022-04-20,ACTUAL,2019-10-16,ACTUAL,2019-10-16,2022-03,2022-03-31,2021-06-25,ACTUAL,2021-06-25,2021-03-26,ACTUAL,2021-03-26,,INTERVENTIONAL,,Safety Analysis Set included all participants who took at least 1 dose of the study drug.,Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis,"A Phase 3 Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection and Compensated Cirrhosis",COMPLETED,,PHASE3,37.0,ACTUAL,Gilead Sciences,,1.0,,,f,,,,f,t,f,,,t,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",http://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy",2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,INDUSTRY,,,,,,,2021,1.0
NCT01742273,,2012-12-03,,,2020-10-06,2012-12-03,2012-12-05,ESTIMATED,,,,,,,2020-10-06,2020-10-08,ACTUAL,2013-10,ACTUAL,2013-10-31,2020-10,2020-10-31,2020-07-17,ACTUAL,2020-07-17,2020-07-17,ACTUAL,2020-07-17,,INTERVENTIONAL,VitaVasK,,Vitamin K1 to Slow Progression of Vascular Calcification in HD Patients,Vitamin K1 to Slow Progression of Vascular Calcification in Hemodialysis Patients,TERMINATED,,PHASE3,63.0,ACTUAL,RWTH Aachen University,,2.0,,Termination stopped due to low recruitment rates,f,,,,t,,,,,,,,,,,,,2024-10-15 02:42:24.282671,2024-10-15 02:42:24.282671,OTHER,,,,,,,2020,0.0
NCT03298022,,2017-09-27,2023-03-07,,2024-01-03,2017-09-27,2017-09-29,ACTUAL,2023-07-04,2023-07-06,ACTUAL,,,,2024-01-03,2024-01-05,ACTUAL,2018-05-04,ACTUAL,2018-05-04,2024-01,2024-01-31,2020-06-01,ACTUAL,2020-06-01,2020-04-06,ACTUAL,2020-04-06,,INTERVENTIONAL,TNF,Safety population /The mITT set was defined as all patients who were enrolled and who received at least one dose of ALTB-168 treatment.,"Efficacy&Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC","Efficacy and Safety of ALTB-168 in Patients With Moderate to Severe Active, Anti-TNF Alpha and/or Anti-integrin Refractory Ulcerative Colitis: a 26-week, Open-label, Multi-center, Phase II Proof of Principle Trial",TERMINATED,,PHASE2,24.0,ACTUAL,AltruBio Inc.,,1.0,,As a consequence of operational difficulties at the clinical sites associated with the COVID-19 pandemic,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 04:04:33.270448,2024-10-16 04:04:33.270448,INDUSTRY,,,,,,,2020,0.0
NCT05201937,,2022-01-12,,,2023-04-13,2022-01-12,2022-01-21,ACTUAL,,,,,,,2023-04-13,2023-04-14,ACTUAL,2022-02-23,ACTUAL,2022-02-23,2023-04,2023-04-30,2022-12-11,ACTUAL,2022-12-11,2022-12-11,ACTUAL,2022-12-11,,INTERVENTIONAL,,,A Study of JNJ-64281802 in Healthy Adult Participants,"A Phase 1, Open-Label Study in Healthy Adult Participants to Assess the Pharmacokinetics of JNJ-64281802 Administered as Different Multiple Dose Regimens",COMPLETED,,PHASE1,33.0,ACTUAL,"Janssen Research & Development, LLC",,6.0,,,f,,,,f,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2022,0.0
NCT03229382,,2017-07-10,,,2023-08-14,2017-07-24,2017-07-25,ACTUAL,,,,,,,2023-08-14,2023-08-16,ACTUAL,2018-05-14,ACTUAL,2018-05-14,2023-08,2023-08-31,2020-01-31,ACTUAL,2020-01-31,2020-01-31,ACTUAL,2020-01-31,,INTERVENTIONAL,OPERA-PLRG10,,Efficacy and Safety of Obinutuzumab Preemptive Treatment at the Time of the Molecular Relapse,Evaluation of Efficacy and Safety of Obinutuzumab Preemptive Treatment at the Time of the Molecular Relapse After First Line Immunochemotherapy With Autologous Stem Cell (ML29157).,TERMINATED,,PHASE2,1.0,ACTUAL,Polish Lymphoma Research Group,,1.0,,Very slow recruitment due to lack of relapse in the observed group of patients,f,,,,f,f,f,,,f,,,,,,,,2024-10-16 13:00:33.526766,2024-10-16 13:00:33.526766,NETWORK,,,,,,,2020,0.0
NCT02514031,,2015-06-17,,,2022-05-31,2015-07-30,2015-08-03,ESTIMATED,,,,,,,2022-05-31,2022-06-03,ACTUAL,2016-03-24,ACTUAL,2016-03-24,2022-05,2022-05-31,2022-05,ACTUAL,2022-05-31,2018-05-22,ACTUAL,2018-05-22,,INTERVENTIONAL,,,ARQ-761 Treatment With Gemcitabine/Nab-Paclitaxel Chemotherapy In Pancreatic Cancer,"A Phase I/Ib, Single-Arm, Open-Label, Multi-Center Trial Using ARQ-761 (Beta-Lapachone) Treatment With Gemcitabine/Nab-Paclitaxel Chemotherapy In Metastatic, Unresectable, Or Recurrent Pancreatic Cancer",TERMINATED,,PHASE1,17.0,ACTUAL,University of Texas Southwestern Medical Center,,1.0,,The study placed on temporarily hold to enrollment due to quality testing necessary for the study drug.,f,,,,t,,,,,,,,,,,,,2024-10-16 13:00:33.526766,2024-10-16 13:00:33.526766,OTHER,,,,,,,2022,0.0
NCT05113901,,2021-10-17,2023-08-09,,2023-10-19,2021-10-29,2021-11-09,ACTUAL,2023-10-19,2023-10-23,ACTUAL,,,,2023-10-19,2023-10-23,ACTUAL,2022-03-03,ACTUAL,2022-03-03,2023-10,2023-10-31,2022-07-25,ACTUAL,2022-07-25,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,,"The study was terminated early, only 4 subjects were consented, none were randomized to the placebo by the time the study ended.",Medrol Dosepak Taper for Delayed Post-op Recovery After TKA,Methylprednisolone Taper to Treat Delayed Post-Operative Recovery After Total Knee Arthroplasty: a Double-Blind Randomized Controlled Trial,TERMINATED,,PHASE4,4.0,ACTUAL,Rush University Medical Center,,2.0,,"Extremely low participation, decided to focus on similar study instead",f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 13:00:33.526766,2024-10-16 13:00:33.526766,OTHER,,,,,,,2022,0.0
NCT05062577,,2021-09-21,,,2022-07-03,2021-09-21,2021-09-30,ACTUAL,,,,,,,2022-07-03,2022-07-07,ACTUAL,2021-11-08,ACTUAL,2021-11-08,2022-06,2022-06-30,2023-02-28,ESTIMATED,2023-02-28,2023-02-28,ESTIMATED,2023-02-28,,INTERVENTIONAL,,,A Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants With Opioid Use Disorder,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants With Opioid Use Disorder",WITHDRAWN,,PHASE2,0.0,ACTUAL,Astellas Pharma Inc,,2.0,,Due to corporate strategic considerations,f,,,,t,t,f,,,,,,,,,NO,Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.,2024-10-16 04:04:33.270448,2024-10-16 04:04:33.270448,INDUSTRY,,,,,,,2023,0.0
NCT01784861,,2013-02-04,2021-05-13,,2021-06-15,2013-02-05,2013-02-06,ESTIMATED,2021-05-13,2021-06-10,ACTUAL,,,,2021-06-15,2021-07-08,ACTUAL,2013-05-03,ACTUAL,2013-05-03,2021-06,2021-06-30,2020-08-19,ACTUAL,2020-08-19,2020-08-19,ACTUAL,2020-08-19,,INTERVENTIONAL,,,VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Everolimus for Treating Patients With Pancreatic Neuroendocrine Tumors,"A Phase I/II Study of X-82, an Oral Anti-VEGFR Tyrosine Kinase Inhibitor, With Everolimus for Patients With Pancreatic Neuroendocrine Tumors",TERMINATED,,PHASE1/PHASE2,23.0,ACTUAL,Washington University School of Medicine,,6.0,,Pharmaceutical company decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 04:04:33.270448,2024-10-16 04:04:33.270448,OTHER,,,,,,,2020,0.0
NCT03620162,,2018-08-03,2021-07-28,,2023-01-12,2018-08-03,2018-08-08,ACTUAL,2021-07-28,2021-08-23,ACTUAL,,,,2023-01-12,2023-01-17,ACTUAL,2018-10-18,ACTUAL,2018-10-18,2023-01,2023-01-31,2020-12-14,ACTUAL,2020-12-14,2020-12-14,ACTUAL,2020-12-14,,INTERVENTIONAL,,,A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION),"A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)",COMPLETED,,PHASE3,900.0,ACTUAL,Merck Sharp & Dohme LLC,,5.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2020,1.0
NCT02658812,,2016-01-14,2022-10-24,,2023-01-05,2016-01-15,2016-01-20,ESTIMATED,2023-01-05,2023-01-25,ACTUAL,,,,2023-01-05,2023-01-25,ACTUAL,2016-08-01,ACTUAL,2016-08-01,2023-01,2023-01-31,2021-12-01,ACTUAL,2021-12-01,2021-12-01,ACTUAL,2021-12-01,,INTERVENTIONAL,,,Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery,A Phase II Study Using Talimogene Laherparepvec for Inflammatory Breast Cancer (IBC) or Non-IBC Patients With Inoperable Local Recurrence,TERMINATED,,PHASE2,11.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Per PI,f,,,,f,t,f,,,,,,,,,,,2024-10-16 04:04:33.270448,2024-10-16 04:04:33.270448,OTHER,,,,,,,2021,0.0
NCT02933697,,2016-10-07,,,2022-09-26,2016-10-12,2016-10-14,ESTIMATED,,,,,,,2022-09-26,2022-09-27,ACTUAL,2017-06-20,ACTUAL,2017-06-20,2022-09,2022-09-30,2022-07-31,ACTUAL,2022-07-31,2022-07-31,ACTUAL,2022-07-31,,INTERVENTIONAL,AXADIA,,Compare Apixaban and Vitamin-K Antagonists in Patients With Atrial Fibrillation (AF) and End-Stage Kidney Disease (ESKD),A Safety Study Assessing Oral Anticoagulation With Apixaban Versus Vitamin-K Antagonists in Patients With Atrial Fibrillation (AF) and End-Stage Kidney Disease (ESKD) on Chronic Hemodialysis Treatment,COMPLETED,,PHASE3,108.0,ACTUAL,Atrial Fibrillation Network,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,OTHER,,,,,,,2022,1.0
NCT04882176,,2021-04-22,,,2023-07-25,2021-05-07,2021-05-11,ACTUAL,,,,,,,2023-07-25,2023-07-27,ACTUAL,2021-05-20,ACTUAL,2021-05-20,2021-04,2021-04-30,2023-07-19,ACTUAL,2023-07-19,2023-02-07,ACTUAL,2023-02-07,,INTERVENTIONAL,,,A Clinical Study Preliminary Efficacy of LM-061 Tablet in Subjects With Advanced Tumours,"A Phase I/II, First-in-Human, Open-Label, Dose-Escalation and Dose-Extension Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-061 Tablet in Subjects With Advanced Tumours",TERMINATED,,PHASE1/PHASE2,18.0,ACTUAL,LaNova Medicines Limited,,7.0,,Not meeting expected endpoints,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,INDUSTRY,,,,,,,2023,0.0
NCT03829449,,2018-12-20,,,2021-06-22,2019-02-01,2019-02-04,ACTUAL,,,,,,,2021-06-22,2021-06-28,ACTUAL,2017-03-13,ACTUAL,2017-03-13,2021-06,2021-06-30,2020-08-29,ACTUAL,2020-08-29,2020-08-29,ACTUAL,2020-08-29,,INTERVENTIONAL,CONSERVE,,rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study,CONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study,TERMINATED,,PHASE3,15.0,ACTUAL,AKARI Therapeutics,,1.0,,"The early termination of this study is a business decision, Akari have made the decision to close their global Phase III PNH program. The decision was not related to any efficacy, safety or clinical concerns regarding Coversin/rVA576.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 13:00:33.526766,2024-10-16 13:00:33.526766,INDUSTRY,,,,,,,2020,0.0
NCT04526912,,2020-08-21,,,2021-12-16,2020-08-21,2020-08-26,ACTUAL,,,,,,,2021-12-16,2021-12-17,ACTUAL,2020-08-28,ACTUAL,2020-08-28,2021-12,2021-12-31,2021-05-19,ACTUAL,2021-05-19,2021-04-08,ACTUAL,2021-04-08,,INTERVENTIONAL,ALI,,Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection,A Proof of Concept Study of the Safety and Efficacy of VIB7734 for the Treatment and Prevention of Acute Lung Injury (ALI) in Patients With SARS-CoV-2 Infection,TERMINATED,,PHASE1,10.0,ACTUAL,Viela Bio (acquired by Horizon Therapeutics),,2.0,,Study met predefined futility criteria for efficacy endpoints.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:48:17.139017,2024-10-15 02:48:17.139017,INDUSTRY,,,,,,,2021,0.0
NCT03980938,,2019-06-07,2021-10-23,,2022-04-04,2019-06-07,2019-06-10,ACTUAL,2022-04-04,2022-04-06,ACTUAL,,,,2022-04-04,2022-04-06,ACTUAL,2019-07-08,ACTUAL,2019-07-08,2022-04,2022-04-30,2020-10-15,ACTUAL,2020-10-15,2020-10-15,ACTUAL,2020-10-15,,INTERVENTIONAL,,,Within Subject Crossover Study of Cognitive Effects of Neflamapimod in Early-Stage Huntington Disease,"A Double-Blind, Placebo-Controlled Two-Period 10-Week Treatment Within-Subject Crossover Study Of Cognitive Effects Of Neflamapimod in Early-Stage Huntington Disease (HD)",TERMINATED,,PHASE2,15.0,ACTUAL,EIP Pharma Inc,"Due COVID-19 pandemic all clinical research in the UK was halted in March 2020. Sponsor ultimately elected to terminate the study on 15 October 2020. As only one subject completed both periods of the crossover, the only efficacy analyses compared outcomes in subjects receiving neflamapimod (N=7) during Treatment period 1 to those receiving placebo during that period (N=8); i.e., an inter-subject group comparison, rather than the within-subject comparison for which the study was powered.",2.0,,"Due to the long delay because of COVID-19 and results from another study suggesting a higher dose may be more beneficial, EIP Pharma decided on October 15th, 2020, to end the trial prematurely.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,INDUSTRY,,,,,,,2020,0.0
NCT03604445,,2018-07-20,2023-07-24,,2023-07-24,2018-07-20,2018-07-27,ACTUAL,2023-07-24,2024-03-04,ACTUAL,,,,2023-07-24,2024-03-04,ACTUAL,2018-08-08,ACTUAL,2018-08-08,2023-07,2023-07-31,2022-07-27,ACTUAL,2022-07-27,2022-07-27,ACTUAL,2022-07-27,,INTERVENTIONAL,,Treated Set (TS): includes all patients who received at least one infusion of BI 905677.,This Study Aims to Find and Test a Safe Dose of BI 905677 in Patients With Different Types of Cancer (Solid Tumours),"An Open-label, Phase I Trial to Determine the Maximum-tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 905677 Administered Intravenously in Patients With Advanced Solid Tumours",TERMINATED,,PHASE1,37.0,ACTUAL,Boehringer Ingelheim,Recruitment into Schedule B was planned start after the maximum tolerated dose of Schedule A was reached. Study was terminated prematurely due to sponsor decision before Schedule B starting. The planned Schedule B part was not held.,9.0,,Sponsor decision,f,,,,f,t,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,INDUSTRY,,,,,,,2022,0.0
NCT04889040,,2021-05-10,2022-05-30,,2023-03-28,2021-05-10,2021-05-17,ACTUAL,2023-03-28,2024-01-05,ACTUAL,,,,2023-03-28,2024-01-05,ACTUAL,2021-04-28,ACTUAL,2021-04-28,2023-03,2023-03-31,2021-12-02,ACTUAL,2021-12-02,2021-12-02,ACTUAL,2021-12-02,,INTERVENTIONAL,MORNINGSKY,,Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19,"A Multicenter, Phase III Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Evaluate the Efficacy, Safety, Antiviral Activity of RO7496998 (AT-527) in Patients With Mild or Moderate COVID-19",TERMINATED,,PHASE3,216.0,ACTUAL,Hoffmann-La Roche,The study was terminated with only 16% of the planned sample size.,2.0,,Based on program revaluation and in agreement with the co-development partner the sponsor took the decision to terminate this study.,f,,,,t,f,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)",2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2021,0.0
NCT03439033,,2018-02-13,2022-04-24,,2023-02-15,2018-02-13,2018-02-20,ACTUAL,2023-02-15,2023-03-13,ACTUAL,,,,2023-02-15,2023-03-13,ACTUAL,2018-04-03,ACTUAL,2018-04-03,2023-02,2023-02-28,2021-05-05,ACTUAL,2021-05-05,2021-05-05,ACTUAL,2021-05-05,,INTERVENTIONAL,,,Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer,A Phase 2 Comparison Study of 68Ga-PSMA-HBED-CC Positron Emission Tomography (PET)/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer,TERMINATED,,PHASE2,273.0,ACTUAL,Weill Medical College of Cornell University,"One limitation is the small number of cases available for specificity analysis resulting in a negligible sample size of patients who had a true negative reference. Another limitation is multiple patients sought care at other institutions. As a result, information was not complete for several patients. Only a small number of the subjects had 2-year follow-up or underwent confirmatory biopsy, which introduces the possibility of selection bias.",3.0,,Study Drug was FDA approved Summer 2021,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,OTHER,,,,,,,2021,0.0
NCT04280055,,2020-02-12,,,2022-08-08,2020-02-19,2020-02-21,ACTUAL,,,,,,,2022-08-08,2022-08-10,ACTUAL,2020-01-21,ACTUAL,2020-01-21,2022-08,2022-08-31,2022-06-01,ACTUAL,2022-06-01,2020-11-01,ACTUAL,2020-11-01,,INTERVENTIONAL,EPOCH,,Prophylactic Effects of Psilocybin on Chronic Cluster Headache,Prophylactic Effects of Psilocybin on Chronic Cluster Headache: an Open-label Clinical Trial and Neuroimaging Study,TERMINATED,,PHASE1/PHASE2,10.0,ACTUAL,"Rigshospitalet, Denmark",,1.0,,Not possible to achieve the anticipated no. of patients due to Covid-19 pandemic,f,,,,t,f,f,,,,,,,,,YES,Via database of Center for integrated Molecular Brain Imaging (CIMBI) data will be available for neuroscience research community contingent on approval by scientific board.,2024-10-15 02:48:17.139017,2024-10-15 02:48:17.139017,OTHER,,,,,,,2022,0.0
NCT04909723,,2021-05-07,,,2023-05-16,2021-05-26,2021-06-02,ACTUAL,,,,,,,2023-05-16,2023-05-17,ACTUAL,2021-06-02,ACTUAL,2021-06-02,2023-05,2023-05-31,2023-04-06,ACTUAL,2023-04-06,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,,,"Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects","Phase 1-2a Safety, Tolerability, and Pharmacodynamics Controlled Study of NOV-001 in Healthy Volunteers and Patients With Enteric Hyperoxaluria",TERMINATED,,PHASE1/PHASE2,153.0,ACTUAL,Novome Biotechnologies Inc,,8.0,,Sponsor decision to discontinue study.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2023,0.0
NCT00789165,,2008-11-08,,,2020-02-12,2008-11-10,2008-11-11,ESTIMATED,,,,,,,2020-02-12,2020-02-13,ACTUAL,2009-12,,2009-12-31,2020-02,2020-02-29,2020-12-31,ESTIMATED,2020-12-31,2020-02,ACTUAL,2020-02-29,,INTERVENTIONAL,,,Empiric Quinidine for Asymptomatic Brugada Syndrome,A Prospective Trial Of Empiric Quinidine Therapy For Asymptomatic Brugada Syndrome.,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,International Registry of Asymptomatic Brugada Syndrome,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,OTHER,,,,,,,2020,0.0
NCT03857256,,2019-02-13,2023-04-13,,2023-04-13,2019-02-26,2019-02-27,ACTUAL,2023-04-13,2024-01-16,ACTUAL,,,,2023-04-13,2024-01-16,ACTUAL,2019-05-31,ACTUAL,2019-05-31,2023-04,2023-04-30,2021-12-31,ACTUAL,2021-12-31,2021-08-31,ACTUAL,2021-08-31,,INTERVENTIONAL,BetAvena,,Compare the Efficacy and Safety of Beta-Glucan as Add-On to Statin in Subjects With Hyperlipidemia.,"A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study To Compare The Efficacy And Safety Of High-Medium Molecular Weight Beta-Glucan As Add-On To Statin Therapy In Subjects With Hyperlipidemia.",COMPLETED,,PHASE2,263.0,ACTUAL,Montreal Heart Institute,,4.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,OTHER,,,,,,,2021,1.0
NCT04581915,,2020-09-16,,,2022-07-29,2020-10-07,2020-10-09,ACTUAL,,,,,,,2022-07-29,2022-08-02,ACTUAL,2020-09-08,ACTUAL,2020-09-08,2020-10,2020-10-31,2021-04-20,ACTUAL,2021-04-20,2021-04-20,ACTUAL,2021-04-20,,INTERVENTIONAL,PHRUCov01,,PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19,"A Pragmatic, Individually Randomised, Double-blind, Placebo-controlled Trial of Triazavirin (TZV) for the Treatment of Mild-moderate SARS-CoV-2 Infection A Phase II and III Clinical Trial",TERMINATED,,PHASE2/PHASE3,74.0,ACTUAL,Wits Health Consortium (Pty) Ltd,,2.0,,DSMB report,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,OTHER,,,,,,,2021,0.0
NCT03854500,,2019-01-21,,,2023-09-14,2019-02-24,2019-02-26,ACTUAL,,,,,,,2023-09-14,2023-09-15,ACTUAL,2019-10-28,ACTUAL,2019-10-28,2022-05,2022-05-31,2021-12-31,ACTUAL,2021-12-31,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,NOR-TEST 2,,The Norwegian Tenecteplase Stroke Trial 2,A Randomised Trial of Tenecteplase vs. Alteplase in Acute Ischemic Stroke,TERMINATED,,PHASE3,201.0,ACTUAL,Haukeland University Hospital,,2.0,,Per protocol safety analysis 200 patients showed a significant difference in bleeding rates between the two drug groups.,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,OTHER,,,,,,,2021,0.0
NCT04002310,,2019-06-27,2023-08-07,,2023-09-12,2019-06-27,2019-06-28,ACTUAL,2023-09-12,2023-09-15,ACTUAL,,,,2023-09-12,2023-09-15,ACTUAL,2019-07-26,ACTUAL,2019-07-26,2023-09,2023-09-30,2022-08-09,ACTUAL,2022-08-09,2022-08-09,ACTUAL,2022-08-09,,INTERVENTIONAL,,Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.,A Study to Test How Well Different Doses of BI 754132 Are Tolerated in Patients With an Advanced Form of Age-related Macular Degeneration Called Geographic Atrophy,"Safety, Tolerability and Pharmacokinetics of Single Rising Intravitreal Doses and Multiple Intravitreal Dosing of BI 754132 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration (Open Label, Non-randomized, Uncontrolled).",TERMINATED,,PHASE1,18.0,ACTUAL,Boehringer Ingelheim,"The trial was terminated prematurely based on a negative benefit-risk assessment, which was based on the analysis of the safety data during the trial.",5.0,,The trial was discontinued in the interests of patients considering benefit/risk balance.,f,,,,t,t,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,INDUSTRY,,,,,,,2022,0.0
NCT05315479,,2022-03-15,2023-07-28,,2023-08-22,2022-04-04,2022-04-07,ACTUAL,2023-08-22,2023-09-13,ACTUAL,,,,2023-08-22,2023-09-13,ACTUAL,2022-02-24,ACTUAL,2022-02-24,2023-08,2023-08-31,2022-07-07,ACTUAL,2022-07-07,2022-07-07,ACTUAL,2022-07-07,,INTERVENTIONAL,,,Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery,"A Phase 4, Multicenter, Open-Label Study to Evaluate the Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery",TERMINATED,,PHASE4,19.0,ACTUAL,Baudax Bio,,1.0,,Anjeso (N1539) NDA Withdrawn,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:48:17.139017,2024-10-15 02:48:17.139017,INDUSTRY,,,,,,,2022,0.0
NCT05321979,,2022-03-23,,,2024-01-12,2022-04-04,2022-04-11,ACTUAL,,,,,,,2024-01-12,2024-01-16,ACTUAL,2022-02-07,ACTUAL,2022-02-07,2024-01,2024-01-31,2023-05-30,ACTUAL,2023-05-30,2023-05-30,ACTUAL,2023-05-30,,INTERVENTIONAL,,,Long-term Extension Study to Evaluate MBA-P01 in Subjects With Moderate to Severe Glabellar Lines,"Open-label, Single Group, Multi-center, Repeat-dose Long-term Extension Study to Evaluate the Long-term Safety and Efficacy of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines",COMPLETED,,PHASE3,253.0,ACTUAL,Medy-Tox,,1.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,INDUSTRY,,,,,,,2023,1.0
NCT05309902,,2022-03-30,,,2022-11-09,2022-03-30,2022-04-04,ACTUAL,,,,,,,2022-11-09,2022-11-14,ACTUAL,2022-10-11,ESTIMATED,2022-10-11,2022-11,2022-11-30,2022-12-06,ESTIMATED,2022-12-06,2022-12-06,ESTIMATED,2022-12-06,,INTERVENTIONAL,,,A Study of Soticlestat in Healthy Adults To Evaluate the Effect on QTc Interval,"A Phase 1, Double-Blinded, Placebo- and Active-Controlled, Randomized Study to Investigate the Potential of Soticlestat to Prolong the QTc Interval in Healthy Adult Participants",WITHDRAWN,,PHASE1,0.0,ACTUAL,Takeda,,4.0,,Study not needed,f,,,,f,t,f,,,f,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 02:48:17.139017,2024-10-15 02:48:17.139017,INDUSTRY,,,,,,,2022,0.0
NCT04140396,,2019-10-16,2023-09-26,,2023-11-07,2019-10-24,2019-10-25,ACTUAL,2023-11-07,2023-11-30,ACTUAL,,,,2023-11-07,2023-11-30,ACTUAL,2020-02-10,ACTUAL,2020-02-10,2023-11,2023-11-30,2020-11-09,ACTUAL,2020-11-09,2020-11-09,ACTUAL,2020-11-09,,INTERVENTIONAL,,,Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia,A Prospective Comparison of Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia,TERMINATED,,PHASE4,1.0,ACTUAL,Stanford University,This study did not meet its planned enrollment size and did not achieve statistical significance as prespecified in the study protocol.,2.0,,Lack of personnel and lack of funding for the study drug,f,,,,f,t,f,,,t,,,,,,,,2024-10-15 02:48:17.139017,2024-10-15 02:48:17.139017,OTHER,,,,,,,2020,0.0
NCT05182047,,2021-12-20,,,2022-05-16,2021-12-20,2022-01-10,ACTUAL,,,,,,,2022-05-16,2022-05-20,ACTUAL,2022-03-18,ESTIMATED,2022-03-18,2022-05,2022-05-31,2022-05-05,ESTIMATED,2022-05-05,2022-05-05,ESTIMATED,2022-05-05,,INTERVENTIONAL,,,A Study of Butamirate Citrate Syrup Versus (vs) Sinecod Syrup (Vanilla) in Adult Healthy Study Volunteers,"A Randomized, Open, Crossover, Single Dose, Bioequivalence Study of a Novel Medication Butamirate Citrate Syrup 1.5 mg/mL (McNeil Iberica S.L.U., Spain) vs. Sinecod Syrup (Vanilla) 1.5 mg/mL (GSK Consumer Healthcare S.A., Switzerland), in Adult Healthy Study Volunteers",WITHDRAWN,,PHASE1,0.0,ACTUAL,Johnson & Johnson Consumer and Personal Products Worldwide,,2.0,,Business decision.,f,,,,f,f,f,,,,,,,,http://yoda.yale.edu,YES,Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.,2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,INDUSTRY,,,,,,,2022,0.0
NCT03170661,,2017-04-25,2020-10-16,,2021-04-21,2017-05-26,2017-05-31,ACTUAL,2021-02-02,2021-02-21,ACTUAL,,,,2021-04-21,2021-05-13,ACTUAL,2017-06-14,ACTUAL,2017-06-14,2021-04,2021-04-30,2020-06-01,ACTUAL,2020-06-01,2020-04-01,ACTUAL,2020-04-01,,INTERVENTIONAL,BLISS4,,Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions.,Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions in Patients Undergoing Laparoscopic Renal Surgery,COMPLETED,,PHASE4,98.0,ACTUAL,Leiden University Medical Center,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 02:48:17.139017,2024-10-15 02:48:17.139017,OTHER,,,,,,,2020,1.0
NCT04995536,,2021-07-20,,,2024-04-24,2021-07-29,2021-08-09,ACTUAL,,,,,,,2024-04-24,2024-04-25,ACTUAL,2021-07-27,ACTUAL,2021-07-27,2024-04,2024-04-30,2024-01-04,ACTUAL,2024-01-04,2024-01-04,ACTUAL,2024-01-04,,INTERVENTIONAL,,,CpG-STAT3 siRNA CAS3/SS3 and Localized Radiation Therapy for the Treatment of Relapsed/Refractory B-Cell NHL,A Phase I Study of Intratumoral Injections of CpG-STAT3 siRNA (CAS3/SS3) in Combination With Local Radiation in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (NHL),WITHDRAWN,,PHASE1,0.0,ACTUAL,City of Hope Medical Center,,1.0,,no accrual,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 02:48:17.139017,2024-10-15 02:48:17.139017,OTHER,,,,,,,2024,0.0
NCT04556760,,2020-09-15,2022-04-28,,2024-02-02,2020-09-15,2020-09-21,ACTUAL,2024-02-02,2024-07-18,ACTUAL,,,,2024-02-02,2024-07-18,ACTUAL,2020-11-26,ACTUAL,2020-11-26,2024-02,2024-02-29,2021-06-09,ACTUAL,2021-06-09,2021-06-09,ACTUAL,2021-06-09,,INTERVENTIONAL,,Full Analysis Set (FAS) consisted of all randomised patients who received at least 1 dose of study treatment.,"Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes","A Phase 2a Randomised, Double Blind, Multi-centre Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes",COMPLETED,,PHASE2,46.0,ACTUAL,AstraZeneca,,3.0,,,f,,,,f,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.~Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2021,1.0
NCT03563222,,2018-06-05,2022-09-30,,2022-11-15,2018-06-19,2018-06-20,ACTUAL,2022-11-15,2022-12-12,ACTUAL,,,,2022-11-15,2022-12-12,ACTUAL,2019-12-18,ACTUAL,2019-12-18,2022-11,2022-11-30,2022-07-08,ACTUAL,2022-07-08,2020-11-12,ACTUAL,2020-11-12,,INTERVENTIONAL,,Study was prematurely terminated,Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age,"Prospective, Randomized (1:1), Double-Blind, Parallel-Group, Active-Controlled, Multicenter Study to Compare Safety and Efficacy of Smoflipid to Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age Requiring Parenteral Nutrition for at Least 90 Days and up to 1 Year",TERMINATED,,PHASE4,1.0,ACTUAL,Fresenius Kabi,"The study was released from postmarketing requirement and the product received marketing authorization approval from the U.S. Food \& Drug Administration. Therefore, the study was early terminated after treatment of a single patient.",2.0,,Prematurely stopped in agreement with authorities (FDA),f,,,,t,t,f,,,,,,,,,,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2022,0.0
NCT02167945,,2014-06-18,2022-03-11,,2022-06-27,2014-06-18,2014-06-19,ESTIMATED,2022-03-11,2022-04-06,ACTUAL,,,,2022-06-27,2022-07-19,ACTUAL,2014-06-12,ACTUAL,2014-06-12,2022-06,2022-06-30,2021-05-13,ACTUAL,2021-05-13,2021-05-13,ACTUAL,2021-05-13,,INTERVENTIONAL,TOPAZ-II,Safety population: All participants enrolled in this study (M14-222; TOPAZ-II) who received at least one dose of study drug,A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection,"An Open-Label, Multicenter Study to Evaluate Long-term Outcomes With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-II)",COMPLETED,,PHASE3,615.0,ACTUAL,AbbVie,,1.0,,,f,,,,t,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,INDUSTRY,,,,,,,2021,1.0
NCT03634800,,2018-08-14,2021-06-07,2021-03-17,2021-07-14,2018-08-14,2018-08-16,ACTUAL,2021-07-14,2021-08-05,ACTUAL,2021-07-14,2021-08-05,ACTUAL,2021-07-14,2021-08-05,ACTUAL,2018-10-23,ACTUAL,2018-10-23,2021-07,2021-07-31,2020-01-16,ACTUAL,2020-01-16,2020-01-09,ACTUAL,2020-01-09,,INTERVENTIONAL,RISE-M,6 patients enrolled but 1 patient withdrew consent prior to starting treatment. 5 patients that enrolled and started treatment will be a part of the analysis population.,Radiotherapy With Immunotherapy for Systemic Effect in Myeloma (RISE-M),Radiotherapy With Immunotherapy for Systemic Effect in Myeloma (RISE-M),TERMINATED,,PHASE2,6.0,ACTUAL,Weill Medical College of Cornell University,,1.0,,Lack of patient accruals.,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,OTHER,,,,,,,2020,0.0
NCT03175549,,2017-06-01,2022-05-05,,2022-08-22,2017-06-02,2017-06-05,ACTUAL,2022-08-22,2022-09-16,ACTUAL,,,,2022-08-22,2022-09-16,ACTUAL,2017-11-01,ACTUAL,2017-11-01,2022-08,2022-08-31,2020-04-01,ACTUAL,2020-04-01,2020-04-01,ACTUAL,2020-04-01,,INTERVENTIONAL,,,Medication Development in Alcoholism: Apremilast Versus Placebo,Medication Development for Protracted Abstinence in Alcoholism: Apremilast Versus Placebo,COMPLETED,,PHASE2,51.0,ACTUAL,The Scripps Research Institute,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,OTHER,,,,,,,2020,1.0
NCT04682431,,2020-12-11,,,2024-03-20,2020-12-22,2020-12-23,ACTUAL,,,,,,,2024-03-20,2024-03-22,ACTUAL,2020-11-10,ACTUAL,2020-11-10,2024-03,2024-03-31,2023-08-31,ACTUAL,2023-08-31,2023-08-25,ACTUAL,2023-08-25,,INTERVENTIONAL,,,A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors,"A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY159 as a Single Agent and In Combination With Pembrolizumab in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,127.0,ACTUAL,Ikena Oncology,,18.0,,Sponsor business decision.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:00:33.526766,2024-10-16 13:00:33.526766,INDUSTRY,,,,,,,2023,0.0
NCT03618108,,2018-08-01,,,2021-07-27,2018-08-01,2018-08-07,ACTUAL,,,,,,,2021-07-27,2021-08-02,ACTUAL,2018-04-04,ACTUAL,2018-04-04,2021-07,2021-07-31,2020-11-30,ACTUAL,2020-11-30,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,ACAC-CHD,,Anti-chlamydophila Antibiotic Combination Therapy in the Treatment of Patients With Coronary Heart Disease,"Phase IIa Prospective Study to Evaluate the Safety and Measure Efficacy of Anti-chlamydophila Antibiotic Combination (ACAC) Therapy Comprising 100mg Doxycycline, 500mg Azithromycin and 300mg Rifabutin in the Treatment of Patients With Coronary Heart Disease (CHD)",TERMINATED,,PHASE2,20.0,ACTUAL,Cadrock Pty. Ltd.,,2.0,,COVID-19,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,OTHER,,,,,,,2020,0.0
NCT04230954,,2020-01-13,,,2022-06-03,2020-01-13,2020-01-18,ACTUAL,,,,,,,2022-06-03,2022-06-07,ACTUAL,2020-04-16,ACTUAL,2020-04-16,2022-06,2022-06-30,2022-02-16,ACTUAL,2022-02-16,2022-02-16,ACTUAL,2022-02-16,,INTERVENTIONAL,,,"Cabozantinib Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer","A Phase II Study of Cabozantinib (XL184) Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer",TERMINATED,,PHASE2,5.0,ACTUAL,University of South Alabama,,1.0,,PI left institution,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:00:33.526766,2024-10-16 13:00:33.526766,OTHER,,,,,,,2022,0.0
NCT01247324,,2010-11-23,2017-03-30,2016-10-10,2024-02-13,2010-11-23,2010-11-24,ESTIMATED,2017-07-17,2017-07-18,ACTUAL,2016-10-10,2016-10-12,ESTIMATED,2024-02-13,2024-03-04,ACTUAL,2011-08-31,ACTUAL,2011-08-31,2024-02,2024-02-29,2022-12-31,ACTUAL,2022-12-31,2015-04-02,ACTUAL,2015-04-02,,INTERVENTIONAL,,Intent-to-treat (ITT) population included all randomized participants in the study.,A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis,"A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis",COMPLETED,,PHASE3,821.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 02:48:17.139017,2024-10-15 02:48:17.139017,INDUSTRY,,,,,,,2022,1.0
NCT05098041,,2021-10-20,2023-02-17,,2023-02-17,2021-10-20,2021-10-28,ACTUAL,2023-02-17,2023-11-22,ACTUAL,,,,2023-02-17,2023-11-22,ACTUAL,2021-11-22,ACTUAL,2021-11-22,2023-02,2023-02-28,2022-03-03,ACTUAL,2022-03-03,2022-02-16,ACTUAL,2022-02-16,,INTERVENTIONAL,,The safety set included all participants who received at least one dose of the study drug(s).,A Study of Soticlestat and Rifampin in Healthy Adults,A Phase 1 Open-Label Study to Evaluate the Drug-Drug Interaction of Rifampin as a Strong CYP3A Inducer on Soticlestat Pharmacokinetics in Healthy Adult Participants,COMPLETED,,PHASE1,15.0,ACTUAL,Takeda,,1.0,,,f,,,,f,t,f,,,f,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,INDUSTRY,,,,,,,2022,1.0
NCT03845894,,2019-01-22,2023-09-25,,2023-11-10,2019-02-18,2019-02-19,ACTUAL,2023-11-10,2023-11-13,ACTUAL,,,,2023-11-10,2023-11-13,ACTUAL,2020-03-03,ACTUAL,2020-03-03,2022-09,2022-09-30,2022-06-25,ACTUAL,2022-06-25,2022-06-25,ACTUAL,2022-06-25,,INTERVENTIONAL,,,Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants,Single Injection Interscalene Brachial Plexus Nerve Block With Adjuvants vs. Liposomal Bupivacaine Interscalene Brachial Plexus Nerve Block for Total Shoulder Arthroplasty,TERMINATED,,PHASE4,25.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,feasibility,f,,,,f,t,f,,,t,,,"Available after study conclusion, for up to 3 years afterward.",,,YES,Will be shared upon request: raw data and statistical calculations,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,OTHER,,,,,,,2022,0.0
NCT06120725,,2023-11-01,,,2023-12-22,2023-11-01,2023-11-07,ACTUAL,,,,,,,2023-12-22,2023-12-29,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2023-12,2023-12-31,2023-11-01,ACTUAL,2023-11-01,2023-09-01,ACTUAL,2023-09-01,,INTERVENTIONAL,,,Ticagrelor Versus Clopidogrel in Large Vessel Ischemic Stroke,"Ticagrelor Versus Clopidogrel in Large Vessel Ischemic Stroke, a Randomized Controlled Trial",COMPLETED,,PHASE3,580.0,ACTUAL,Kafrelsheikh University,,2.0,,,f,,,,f,t,f,,,t,,,,,,UNDECIDED,All the data that support the findings of this research will be available from the corresponding author M. Zeinhom upon reasonable request.,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,OTHER,,,,,,,2023,1.0
NCT04539275,,2020-08-27,2022-06-24,,2022-09-09,2020-09-03,2020-09-04,ACTUAL,2022-08-16,2022-09-10,ACTUAL,,,,2022-09-09,2022-09-23,ACTUAL,2020-11-16,ACTUAL,2020-11-16,2022-09,2022-09-30,2021-09-30,ACTUAL,2021-09-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,VACURES-1,,VA CoronavirUs Research and Efficacy Studies-1,VA CoronavirUs Research and Efficacy Studies-1 (VA CURES-1),TERMINATED,,PHASE3,75.0,ACTUAL,VA Office of Research and Development,,2.0,,DMC recommended early termination of enrollment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,FED,,,,,,,2021,0.0
NCT03971110,,2019-03-21,,,2022-12-14,2019-05-31,2019-06-03,ACTUAL,,,,,,,2022-12-14,2022-12-16,ACTUAL,2021-01-28,ACTUAL,2021-01-28,2022-12,2022-12-31,2022-11-09,ACTUAL,2022-11-09,2022-11-09,ACTUAL,2022-11-09,,INTERVENTIONAL,,,A Study of Neoadjuvant Hormone Therapy in Patient With Advanced Prostate Cancer Undergoing Radical Prostatectomy.,"A Multi-centre, Single-arm, Prospective Study to Assess Efficacy and Safety of Neoadjuvant Hormone Therapy Using Zoladex (Goserelin) and Casodex (Bicalutamide) in Patients With Advanced Prostate Cancer Undergoing Radical Prostatectomy.",TERMINATED,,PHASE4,9.0,ACTUAL,AstraZeneca,,1.0,,"Due to the limited potential patients pool, the enrollment goal could not be achieved. After review and communication, the decision to teminate study was made.",f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,INDUSTRY,,,,,,,2022,0.0
NCT04126733,,2019-10-11,2021-11-03,,2023-06-25,2019-10-11,2019-10-15,ACTUAL,2021-12-12,2021-12-14,ACTUAL,,,,2023-06-25,2023-07-18,ACTUAL,2019-10-14,ACTUAL,2019-10-14,2023-06,2023-06-30,2022-03-28,ACTUAL,2022-03-28,2020-11-11,ACTUAL,2020-11-11,,INTERVENTIONAL,,,Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable),"An Open-label, Single-arm, Phase II Study of Regorafenib and Nivolumab in Patients With Mismatch Repair-Proficient (pMMR)/Microsatellite Stable (MSS) Colorectal Cancer (CRC)",COMPLETED,,PHASE2,70.0,ACTUAL,Bayer,"Preliminary efficacy assessment suggested that the study would not meet its primary efficacy endpoint, therefore the study was stopped.",1.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,INDUSTRY,,,,,,,2022,1.0
NCT04088734,,2019-09-11,2023-06-09,2023-01-11,2023-07-02,2019-09-11,2019-09-13,ACTUAL,2023-07-02,2023-07-25,ACTUAL,,2023-07-25,ACTUAL,2023-07-02,2023-07-25,ACTUAL,2019-09-18,ACTUAL,2019-09-18,2023-07,2023-07-31,2022-03-10,ACTUAL,2022-03-10,2022-03-10,ACTUAL,2022-03-10,,INTERVENTIONAL,,,Gene Transfer Study of ABO-102 in Patients With Middle and Advanced Phases of MPS IIIA Disease,"A Phase I/II Open Label, Single-dose, Gene Transfer Study of scAAV9.U1a.hSGSH (ABO-102) in Patients With Middle and Advanced Phases of MPS IIIA Disease",TERMINATED,,PHASE1/PHASE2,5.0,ACTUAL,Ultragenyx Pharmaceutical Inc,,1.0,,Terminated due to lack of efficacy seen in patients with advanced MPS IIIA disease. The patients will be followed up annually for safety until five years post dosing,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,INDUSTRY,,,,,,,2022,0.0
NCT03890289,,2019-03-21,,,2023-07-05,2019-03-22,2019-03-26,ACTUAL,,,,,,,2023-07-05,2023-07-06,ACTUAL,2019-10-18,ACTUAL,2019-10-18,2023-07,2023-07-31,2023-05-10,ACTUAL,2023-05-10,2021-04-29,ACTUAL,2021-04-29,,INTERVENTIONAL,GAUDEALIS,,Idelalisib+Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma,"Idelalisib Plus Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma: a Phase 2, Single-arm, Multicentric Study",TERMINATED,,PHASE2,5.0,ACTUAL,Fondazione Italiana Linfomi - ETS,,1.0,,"Study was halted prematurely due to safety, since tocity stopping rules have been met",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 02:48:17.139017,2024-10-15 02:48:17.139017,OTHER,,,,,,,2023,0.0
NCT02562716,,2015-09-25,2021-06-01,,2022-10-18,2015-09-25,2015-09-29,ESTIMATED,2021-07-02,2021-07-23,ACTUAL,,,,2022-10-18,2022-10-19,ACTUAL,2016-01-06,ACTUAL,2016-01-06,2022-10,2022-10-31,2022-09-26,ACTUAL,2022-09-26,2020-05-31,ACTUAL,2020-05-31,,INTERVENTIONAL,,"147 participants were randomized, but 43 were found to be ineligible per central radiology review, and 1 was found to be ineligible due to incorrect primary tumor. One patient withdrew study consent prior to any therapy and was not evaluable. Therefore 102 were deemed eligible and analyzable for the primary analysis.",S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery,A Randomized Phase II Study of Perioperative mFOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma,COMPLETED,,PHASE2,147.0,ACTUAL,SWOG Cancer Research Network,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 02:48:17.139017,2024-10-15 02:48:17.139017,NETWORK,,,,,,,2022,1.0
NCT04557384,,2020-09-16,2022-05-06,,2023-02-23,2020-09-17,2020-09-21,ACTUAL,2023-02-23,2023-02-27,ACTUAL,,,,2023-02-23,2023-02-27,ACTUAL,2021-02-23,ACTUAL,2021-02-23,2023-02,2023-02-28,2021-05-25,ACTUAL,2021-05-25,2021-05-25,ACTUAL,2021-05-25,,INTERVENTIONAL,,All participants who received at least one dose of study drug.,A Study of Ramucirumab (LY3009806) Given by Injection Under the Skin in Participants With Advanced Cancer,"A Phase 1, Nonrandomized, Open-Label Investigation of Subcutaneous Ramucirumab Administration in Participants With Advanced Solid Tumors",TERMINATED,,PHASE1,3.0,ACTUAL,Eli Lilly and Company,Study was terminated due to low likelihood of achieving a relevant therapeutic exposure.,1.0,,Study terminated due to inadequate PK profile associated with the subcutaneous formulation.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,INDUSTRY,,,,,,,2021,0.0
NCT04556266,,2020-09-15,,,2022-03-04,2020-09-15,2020-09-21,ACTUAL,,,,,,,2022-03-04,2022-03-18,ACTUAL,2021-07-01,ACTUAL,2021-07-01,2022-03,2022-03-31,2022-03-01,ACTUAL,2022-03-01,2022-03-01,ACTUAL,2022-03-01,,INTERVENTIONAL,,,A Phase I Trial of Donor- Derived 19-28z CAR T Cells Following Allogeneic Transplant for the Treatment of CD19 Malignancies,A Phase I Trial Evaluating the Safety of Consolidative Infusions of CD19-Specific Chimeric Antigen Receptor (CAR) T Cells Following T-cell Depleted Allogeneic Transplantation for High Risk B-cell Malignancies,WITHDRAWN,,PHASE1,0.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,4.0,,"No patients were enrolled to this study since being open to enrollment. Due to changes in available therapies, there aren't enough people who will be eligible for the study. Therefore, the study was closed.",,,,,,t,f,,,,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,OTHER,,,,,,,2022,0.0
NCT02535247,,2015-08-26,2022-05-10,,2022-06-14,2015-08-27,2015-08-28,ESTIMATED,2022-06-14,2022-07-08,ACTUAL,,,,2022-06-14,2022-07-08,ACTUAL,2016-01-05,ACTUAL,2016-01-05,2022-06,2022-06-30,2020-02-25,ACTUAL,2020-02-25,2020-02-25,ACTUAL,2020-02-25,,INTERVENTIONAL,,Study did not progress to portion with combination of pembrolizumab and copanlisib,Study of MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma,A Phase I/II Study to Determine Feasibility and Safety MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma,TERMINATED,,PHASE1/PHASE2,17.0,ACTUAL,Fox Chase Cancer Center,,2.0,,Merck no longer providing drug for study,f,,,,t,,,,,,,,,,,,,2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,OTHER,,,,,,,2020,0.0
NCT00116142,,2005-06-27,2021-06-10,,2022-01-06,2005-06-27,2005-06-28,ESTIMATED,2021-07-08,2021-07-28,ACTUAL,,,,2022-01-06,2022-01-11,ACTUAL,2005-06,,2005-06-30,2022-01,2022-01-31,2020-06-29,ACTUAL,2020-06-29,2020-06-29,ACTUAL,2020-06-29,,INTERVENTIONAL,,,Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer,Docetaxel Plus 6-month Androgen Suppression and Radiation Therapy Versus 6-month Androgen Suppression and Radiation Therapy for Patients With High Risk Localized or Locally Advanced Prostate Cancer: A Randomized Controlled Trial,COMPLETED,,PHASE3,350.0,ACTUAL,Dana-Farber Cancer Institute,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,OTHER,,,,,,,2020,1.0
NCT04745351,,2021-02-08,2023-04-18,,2023-04-18,2021-02-08,2021-02-09,ACTUAL,2023-04-18,2023-05-12,ACTUAL,,,,2023-04-18,2023-05-12,ACTUAL,2021-03-31,ACTUAL,2021-03-31,2023-04,2023-04-30,2022-05-24,ACTUAL,2022-05-24,2022-04-20,ACTUAL,2022-04-20,,INTERVENTIONAL,REDPINE,Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.,Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19),"A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for COVID-19",TERMINATED,,PHASE3,249.0,ACTUAL,Gilead Sciences,,2.0,,The study was terminated due to study enrollment feasibility. This decision is not based on efficacy or safety concerns.,t,,,,t,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gileadclinicaltrials.com/transparency-policy/,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/",2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,NCT04323761,APPROVED_FOR_MARKETING,,,,2022,0.0
NCT04506983,,2020-08-06,,,2022-01-29,2020-08-07,2020-08-10,ACTUAL,,,,,,,2022-01-29,2022-02-14,ACTUAL,2022-06-10,ESTIMATED,2022-06-10,2022-01,2022-01-31,2023-10-10,ESTIMATED,2023-10-10,2023-06-10,ESTIMATED,2023-06-10,,INTERVENTIONAL,,,GPC3-CAR-T Cells for the Hepatocellular Carcinoma,The Phase I Efficacy and Safety Clinical Study of GPC3-CAR-T Cells in Hepatocellular Carcinoma Patients,SUSPENDED,,PHASE1,12.0,ESTIMATED,Beijing Tsinghua Chang Gung Hospital,,1.0,,Adjust the plan,f,,,,,f,f,,,,,,,,,,,2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,OTHER,,,,,,,2023,0.0
NCT03434379,,2018-01-31,2021-08-16,,2023-10-05,2018-02-09,2018-02-15,ACTUAL,2021-10-07,2021-11-05,ACTUAL,,,,2023-10-05,2023-10-23,ACTUAL,2018-03-15,ACTUAL,2018-03-15,2023-09,2023-09-30,2022-11-17,ACTUAL,2022-11-17,2020-08-31,ACTUAL,2020-08-31,,INTERVENTIONAL,IMbrave150,The intent-to-treat (ITT) population included 558 participants (All) with 501 in the Global population. An additional 57 participants enrolled in the China Extension. The China population included 137 Chinese participants from the Global population plus 57 participants from the China Extension. The Global population and China population were analyzed separately.,A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma,"A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma",COMPLETED,,PHASE3,558.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,INDUSTRY,,,,,,,2022,1.0
NCT03629483,,2018-08-08,,,2022-04-19,2018-08-11,2018-08-14,ACTUAL,,,,,,,2022-04-19,2022-04-26,ACTUAL,2018-12-10,ACTUAL,2018-12-10,2022-04,2022-04-30,2024-12,ESTIMATED,2024-12-31,2018-12-11,ACTUAL,2018-12-11,,INTERVENTIONAL,,,Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block,Impact of Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block on Postoperative Delirium and Long-term Oucomes in Elderly Patients After Single Knee Arthroplasty,SUSPENDED,,PHASE4,736.0,ESTIMATED,Peking University First Hospital,,2.0,,Trial stopped by the sponsor because of no funding.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,OTHER,,,,,,,2024,0.0
NCT05181995,,2021-12-15,,,2023-04-06,2022-01-04,2022-01-10,ACTUAL,,,,,,,2023-04-06,2023-04-07,ACTUAL,2021-12-13,ACTUAL,2021-12-13,2023-04,2023-04-30,2023-03-30,ACTUAL,2023-03-30,2023-03-30,ACTUAL,2023-03-30,,INTERVENTIONAL,,,Safety and Efficacy of 50 mg NYX-783 QD vs. Placebo in PTSD,"A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 50 mg NYX-783 Once Daily Compared to Placebo in Participants With Post-Traumatic Stress Disorder (PTSD)",TERMINATED,,PHASE2/PHASE3,121.0,ACTUAL,Aptinyx,,2.0,,company decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,INDUSTRY,,,,,,,2023,0.0
NCT03579888,,2018-06-25,,,2021-05-28,2018-07-05,2018-07-09,ACTUAL,,,,,,,2021-05-28,2021-06-02,ACTUAL,2020-06-26,ACTUAL,2020-06-26,2021-05,2021-05-31,2021-05-27,ACTUAL,2021-05-27,2021-05-27,ACTUAL,2021-05-27,,INTERVENTIONAL,,,CD19-Specific T Cells Post AlloSCT,Donor-Derived Very-Rapid Manufactured CD19-Specific T Cells for Lymphoid Malignancies After Allogeneic Hematopoietic Stem-Cell Transplantation,TERMINATED,,PHASE1,4.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Study halted prematurely,,,,,t,t,f,,,,,,,,,,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,OTHER,,,,,,,2021,0.0
NCT04205890,,2019-12-16,,,2020-05-28,2019-12-17,2019-12-20,ACTUAL,,,,,,,2020-05-28,2020-06-01,ACTUAL,2020-05-02,ACTUAL,2020-05-02,2020-05,2020-05-31,2020-05-28,ACTUAL,2020-05-28,2020-05-28,ACTUAL,2020-05-28,,INTERVENTIONAL,,,Intravenous Ketamine Effects on Functional Neuroanatomy,Intravenous Ketamine Effects on Functional Neuroanatomy,WITHDRAWN,,PHASE1,0.0,ACTUAL,Neurological Associates of West Los Angeles,,1.0,,Sponsor is no longer interested in funding the study,f,,,,f,t,f,,,t,,,,,,NO,Data from this study will not be made publicly available due to ethical and privacy concerns. Anonymized data will be available upon reasonable request from any qualified investigator.,2024-10-16 05:05:30.781472,2024-10-16 05:05:30.781472,OTHER,,,,,,,2020,0.0
NCT05394558,,2021-12-16,,,2023-12-19,2022-05-23,2022-05-27,ACTUAL,,,,,,,2023-12-19,2023-12-26,ACTUAL,2022-05-27,ACTUAL,2022-05-27,2023-12,2023-12-31,2023-09-20,ACTUAL,2023-09-20,2023-09-20,ACTUAL,2023-09-20,,INTERVENTIONAL,AsiDNA,,"AsiDNA Children, Adolescents and Young Adults","A Phase Ib/II Study on AsiDNA in Association With Re-irradiation in Children, Adolescents and Young Adults With High-grade Glioma",TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,Institut Curie,,2.0,,IDMC recommendations,f,,,,t,f,f,,,,,,Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months,"Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).",,YES,Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.,2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,OTHER,,,,,,,2023,0.0
NCT02623426,,2015-12-03,2023-04-06,,2023-06-20,2015-12-04,2015-12-07,ESTIMATED,2023-06-20,2023-07-10,ACTUAL,,,,2023-06-20,2023-07-10,ACTUAL,2017-03-09,ACTUAL,2017-03-09,2023-06,2023-06-30,2022-02-02,ACTUAL,2022-02-02,2021-10-27,ACTUAL,2021-10-27,,INTERVENTIONAL,MERIT,"Randomized participants had 1 or both eyes with macular edema, defined as the presence of central subfield macular thickness greater than the normal range for the OCT machine being used",Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial,Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial,COMPLETED,,PHASE3,194.0,ACTUAL,JHSPH Center for Clinical Trials,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,OTHER,,,,,Eyes with Macular Edema,,2022,1.0
NCT04341935,,2020-04-06,,,2021-06-07,2020-04-07,2020-04-10,ACTUAL,,,,,,,2021-06-07,2021-06-10,ACTUAL,2021-06-30,ESTIMATED,2021-06-30,2021-06,2021-06-30,2021-12-30,ESTIMATED,2021-12-30,2021-12-30,ESTIMATED,2021-12-30,,INTERVENTIONAL,,,Effects of DPP4 Inhibition on COVID-19,Effects of DPP4 Inhibition on COVID-19 Patients With Type 2 Diabetes,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Miami,,2.0,,Logistical challenges amid COVID-19 pandemic and lack of financial support,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,OTHER,,,,,,,2021,0.0
NCT04957290,,2021-06-16,2024-03-27,,2024-05-22,2021-06-30,2021-07-12,ACTUAL,2024-05-22,2024-06-18,ACTUAL,,,,2024-05-22,2024-06-18,ACTUAL,2021-10-25,ACTUAL,2021-10-25,2024-05,2024-05-31,2023-06-07,ACTUAL,2023-06-07,2023-05-10,ACTUAL,2023-05-10,,INTERVENTIONAL,,Study terminated early during part 1- cohort 3.,A Study of NOX66 and External Beam Radiotherapy in Patients With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors,A Phase 1b/2a Multicenter Study of NOX66 and External Beam Radiotherapy in Patients With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors,TERMINATED,,PHASE1/PHASE2,21.0,ACTUAL,Noxopharm Limited,"Dose escalation progressed through the first 3 planned dose levels before the Sponsor decided to terminate the study for business reasons; the decision was not based on any safety concerns with NOX66.~Due to early termination, none of the efficacy parameters were able to be measured therefore only safety outcomes are available.",6.0,,Slow Recruitment,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,INDUSTRY,,,,,,,2023,0.0
NCT04643886,,2020-11-16,,,2022-09-22,2020-11-19,2020-11-25,ACTUAL,,,,,,,2022-09-22,2022-09-23,ACTUAL,2020-07-30,ACTUAL,2020-07-30,2022-09,2022-09-30,2022-03-21,ACTUAL,2022-03-21,2022-02-18,ACTUAL,2022-02-18,,INTERVENTIONAL,,,A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Dry Age-related Macular Degeneration,"A Multicenter, Open-label, Multiple Dose Study in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of Repeat Intravitreal Injections of GEM103",TERMINATED,,PHASE2,62.0,ACTUAL,"Gemini Therapeutics, Inc.",,2.0,,no further benefit,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 02:06:08.041457,2024-10-17 02:06:08.041457,INDUSTRY,,,,,,,2022,0.0
NCT04479904,,2020-07-17,,,2021-06-16,2020-07-17,2020-07-21,ACTUAL,,,,,,,2021-06-16,2021-06-22,ACTUAL,2020-08-10,ESTIMATED,2020-08-10,2020-07,2020-07-31,2022-02-10,ESTIMATED,2022-02-10,2021-12-10,ESTIMATED,2021-12-10,,INTERVENTIONAL,,,A Trial of Famitinib in Patients With Failure of First-Line Treatment For Intrahepatic Cholangiocarcinoma,"A Single-Arm, Open-Label, Multi-Center, Phase II Study of Famitinib Malate to Treat Intrahepatic Cholangiocarcinoma Patients With FGFR2(Fibroblast Growth Factor Receptor2) Genetic Aberrations Who Failed First-Line Therapy",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,1.0,,It is difficult to screening subject,,,,,,t,f,,,,,,,,,,,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,INDUSTRY,,,,,,,2022,0.0
NCT03941496,,2019-05-06,,,2023-02-07,2019-05-06,2019-05-08,ACTUAL,,,,,,,2023-02-07,2023-02-08,ACTUAL,2022-10,ESTIMATED,2022-10-31,2023-02,2023-02-28,2023-05,ESTIMATED,2023-05-31,2023-05,ESTIMATED,2023-05-31,,INTERVENTIONAL,AZA,,Azacytidine During Anti-tuberculosis Therapy,Phase 1b/2a Safety and Immunogenicity of the DNMT Inhibitor Azacitidine During Anti-Tuberculosis Therapy,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Baylor College of Medicine,,1.0,,The study was halted prematurely due to Bristol-Myers Squibb's (BMS) decision to withdraw support for this study.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:48:17.139017,2024-10-15 02:48:17.139017,OTHER,,,,,,,2023,0.0
NCT04704050,,2021-01-05,,,2023-04-07,2021-01-07,2021-01-11,ACTUAL,,,,,,,2023-04-07,2023-04-10,ACTUAL,2021-05-15,ACTUAL,2021-05-15,2023-04,2023-04-30,2022-12-20,ACTUAL,2022-12-20,2022-12-20,ACTUAL,2022-12-20,,INTERVENTIONAL,EDORA,,Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence,Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence Post Ablation: The EDORA Trial,TERMINATED,,PHASE4,22.0,ACTUAL,Tulane University,,2.0,,Sponsor withdrew funding,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 02:11:49.720005,2024-10-17 02:11:49.720005,OTHER,,,,,,,2022,0.0
NCT04519424,,2020-08-18,,,2020-10-12,2020-08-18,2020-08-19,ACTUAL,,,,,,,2020-10-12,2020-10-14,ACTUAL,2020-09,ESTIMATED,2020-09-30,2020-10,2020-10-31,2021-05,ESTIMATED,2021-05-31,2021-04,ESTIMATED,2021-04-30,,INTERVENTIONAL,,,CSL324 in COVID-19,"A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate CSL324 in Coronavirus Disease 2019 (COVID-19)",WITHDRAWN,,PHASE2,0.0,ACTUAL,CSL Behring,,2.0,,"Due to business reasons, not safety issues.",f,,,,t,t,f,,,,,,IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.,Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.~An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.~The requesting party must execute an appropriate data sharing agreement before IPD will be made available.,,YES,"CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.~Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.~If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.",2024-10-17 02:11:49.720005,2024-10-17 02:11:49.720005,INDUSTRY,,,,,,,2021,0.0
NCT04610658,,2020-10-26,,,2024-04-01,2020-10-26,2020-10-30,ACTUAL,,,,,,,2024-04-01,2024-04-02,ACTUAL,2020-11-23,ACTUAL,2020-11-23,2024-04,2024-04-30,2023-03-24,ACTUAL,2023-03-24,2023-03-24,ACTUAL,2023-03-24,,INTERVENTIONAL,,,Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC,Activity and Enhancement of Immune Checkpoint Inhibition With Lurbinectedin in Relapsed/Recurrent Small Cell Lung Cancer (SCLC),TERMINATED,,PHASE1,9.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,3.0,,DLTs,,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,OTHER,,,,,,,2023,0.0
NCT03800875,,2018-06-27,,,2021-06-03,2019-01-10,2019-01-11,ACTUAL,,,,,,,2021-06-03,2021-06-08,ACTUAL,2019-02-08,ACTUAL,2019-02-08,2021-06,2021-06-30,2020-09-19,ACTUAL,2020-09-19,2020-09-19,ACTUAL,2020-09-19,,INTERVENTIONAL,Dual,,Insulin-plus-pramlintide Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting,"A Randomized, Controlled, Crossover Trial to Assess a Dual-hormone (Insulin-pramlintide) Closed-loop Delivery Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes",COMPLETED,,PHASE2,24.0,ACTUAL,McGill University,,2.0,,,f,,,,f,f,f,,,t,,,,,,YES,"The raw data (i.e., insulin delivery, glucose levels, individual participant data) and informed consent form could be shared by the corresponding author, ahmad.haidar@mcgill.ca, upon reasonable request for academic purposes, subject to Material Transfer Agreement and approval of McGill University Health Center's Research Ethics Board. All data shared will be de-identified. The study protocol will be available with publication.",2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,OTHER,,,,,,,2020,1.0
NCT03982537,,2019-06-05,,,2022-12-16,2019-06-07,2019-06-11,ACTUAL,,,,,,,2022-12-16,2022-12-19,ACTUAL,2020-06-18,ACTUAL,2020-06-18,2022-12,2022-12-31,2020-06-18,ACTUAL,2020-06-18,2020-06-18,ACTUAL,2020-06-18,,INTERVENTIONAL,,,Effect of N-Acetyl Cysteine (NAC) on the Oral Microbiome,Effect of N-Acetyl Cysteine (NAC) on the Oral Microbiome and on the Degree of Mucositis Developed in Response to Concurrent Chemotherapy and Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck,WITHDRAWN,,PHASE2,0.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,Concept is withdrawn and a different concept will be submitted the near future.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:11:49.720005,2024-10-17 02:11:49.720005,OTHER,,,,,,,2020,0.0
NCT04148261,,2019-10-30,,,2021-09-29,2019-10-30,2019-11-01,ACTUAL,,,,,,,2021-09-29,2021-10-06,ACTUAL,2020-12,ESTIMATED,2020-12-31,2021-09,2021-09-30,2022-12,ESTIMATED,2022-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Epinephrine and Cortisol in Depression,The Effects of Epinephrine and Cortisol on Emotion in Depression,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Stanford University,,4.0,,Principal Investigator left lab before study start,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,OTHER,,,,,,,2022,0.0
NCT04780269,,2021-02-22,,,2023-09-13,2021-03-01,2021-03-03,ACTUAL,,,,,,,2023-09-13,2023-09-15,ACTUAL,2023-12,ESTIMATED,2023-12-31,2023-09,2023-09-30,2024-12,ESTIMATED,2024-12-31,2024-12,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Foley Catheter Versus PGE2 for Labor Induction at Term: a Pilot Study,Foley Catheter Versus Prostaglandin E2 Vaginal Suppository for Labor Induction at Term: a Pilot Study,SUSPENDED,,PHASE4,200.0,ESTIMATED,Guangzhou Women and Children's Medical Center,,2.0,,understaffed,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,OTHER,,,,,,,2024,0.0
NCT05172570,,2021-04-21,2023-05-18,,2024-03-19,2021-12-10,2021-12-29,ACTUAL,2024-03-19,2024-03-21,ACTUAL,,,,2024-03-19,2024-03-21,ACTUAL,2021-04-06,ACTUAL,2021-04-06,2024-03,2024-03-31,2022-03-02,ACTUAL,2022-03-02,2022-02-25,ACTUAL,2022-02-25,,INTERVENTIONAL,,Baseline demographics,Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy,Randomized Prospective Study Comparing Variable Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy,TERMINATED,,PHASE3,20.0,ACTUAL,Indiana University,,3.0,,Study terminated to to shortage if study supplies for epidurals and most enrolled has study deviations due to not receiving correct post study drug assignments.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 02:11:49.720005,2024-10-17 02:11:49.720005,OTHER,,,,,,,2022,0.0
NCT03902080,,2019-04-01,2024-06-11,,2024-07-15,2019-04-01,2019-04-03,ACTUAL,2024-07-15,2024-08-07,ACTUAL,,,,2024-07-15,2024-08-07,ACTUAL,2019-03-26,ACTUAL,2019-03-26,2024-06,2024-06-30,2023-06-15,ACTUAL,2023-06-15,2023-06-15,ACTUAL,2023-06-15,,INTERVENTIONAL,,Full Analysis Set consists of all randomized participants who took at least 1 dose of double-blind study treatment and had at least 1 evaluable change from Baseline mictruition,"Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)","A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)",COMPLETED,,PHASE3,1105.0,ACTUAL,Urovant Sciences GmbH,,2.0,,,f,,,,t,t,f,,,,,,The data will be made available within 24 months after study completion and will be accessible for a time frame appropriate for the approved proposal.,Access to these clinical trial data can be requested by emailing medinfo@urovant.com and will be provided following Urovant review and approval of a research proposal and execution of a Data Sharing Agreement (DSA).,,YES,Urovant is committed to sharing patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Data requests will be reviewed and approved on the basis of scientific merit. All data provided will be anonymized according to applicable laws and regulations.,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,INDUSTRY,,,,,,,2023,1.0
NCT03534102,,2018-04-24,,,2023-02-24,2018-05-11,2018-05-23,ACTUAL,,,,,,,2023-02-24,2023-02-27,ACTUAL,2022-06-06,ESTIMATED,2022-06-06,2023-02,2023-02-28,2024-09-01,ESTIMATED,2024-09-01,2023-09-01,ESTIMATED,2023-09-01,,INTERVENTIONAL,,,Can Simplified and More Detailed Instructions Affect Post-Operative Narcotic Consumption,Can Simplified and More Detailed Instructions Affect Post-Operative Narcotic Consumption,WITHDRAWN,,PHASE4,0.0,ACTUAL,Brigham and Women's Hospital,,3.0,,"Due to limitations caused by COVID, enrollment targets could not be met.",f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 02:48:17.139017,2024-10-15 02:48:17.139017,OTHER,,,,,,,2024,0.0
NCT04221087,,2019-12-29,2023-02-08,,2023-03-15,2020-01-05,2020-01-09,ACTUAL,2023-03-15,2023-03-21,ACTUAL,,,,2023-03-15,2023-03-21,ACTUAL,2020-02-03,ACTUAL,2020-02-03,2023-03,2023-03-31,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,Steroid Use in Non-RSV Bronchiolitis,Dexamethasone Use for the Treatment of Non-RSV Bronchiolitis,TERMINATED,,PHASE4,3.0,ACTUAL,University of Pittsburgh,,2.0,,"COVID19-pandemic, RSV surge",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,OTHER,,,,,,,2022,0.0
NCT04447729,,2020-06-10,,,2021-11-05,2020-06-23,2020-06-25,ACTUAL,,,,,,,2021-11-05,2021-11-09,ACTUAL,2020-10-15,ESTIMATED,2020-10-15,2021-11,2021-11-30,2022-02-10,ESTIMATED,2022-02-10,2022-02-10,ESTIMATED,2022-02-10,,INTERVENTIONAL,,,A Study to Test if Fremanezumab Reduces Pain in Patients With Interstitial Cystitis-Bladder Pain Syndrome,"A Multicenter, Open-label Pilot Study of the Efficacy and Safety of Fremanezumab for Treatment of Female Patients With Interstitial Cystitis-Bladder Pain Syndrome",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Teva Branded Pharmaceutical Products R&D, Inc.",,1.0,,Withdrawn due to logistic reasons,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.",2024-10-17 02:11:49.720005,2024-10-17 02:11:49.720005,INDUSTRY,,,,,,,2022,0.0
NCT04130919,,2019-10-16,2022-07-29,2022-02-03,2022-07-29,2019-10-16,2019-10-18,ACTUAL,2022-07-29,2022-08-24,ACTUAL,2022-02-03,2022-02-07,ACTUAL,2022-07-29,2022-08-24,ACTUAL,2019-12-20,ACTUAL,2019-12-20,2022-07,2022-07-31,2021-12-14,ACTUAL,2021-12-14,2021-02-25,ACTUAL,2021-02-25,,INTERVENTIONAL,Falcon,Safety Analysis Set included all participants who received at least 1 dose of study drug.,Study to Evaluate the Efficacy and Safety of Tilpisertib in Adults With Moderately to Severely Active Ulcerative Colitis,"A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects With Moderately to Severely Active Ulcerative Colitis",TERMINATED,,PHASE2,19.0,ACTUAL,Gilead Sciences,"Gilead made the decision to discontinue the development of tilpisertib since a new molecular entity was able to achieve greater target coverage. The decision was not due to any safety concerns. Since only 19 participants were enrolled, none of the planned statistical analyses were performed. During the coronavirus disease 2019 (COVID-19) pandemic, there were changes to protocol visits and procedures where necessary to mitigate the impact of the pandemic to the study.",4.0,,Sponsor terminated the study since a new molecular entity was able to achieve greater target coverage,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,INDUSTRY,,,,,,,2021,0.0
NCT03093155,,2017-03-22,2024-03-14,,2024-04-17,2017-03-27,2017-03-28,ACTUAL,2024-04-17,2024-05-14,ACTUAL,,,,2024-04-17,2024-05-14,ACTUAL,2017-04-03,ACTUAL,2017-04-03,2024-04,2024-04-30,2022-12-29,ACTUAL,2022-12-29,2022-12-29,ACTUAL,2022-12-29,,INTERVENTIONAL,,Only those that remained on study are included in the baseline characteristics.,Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab,"A Randomized Phase II Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab in Recurrent or Persistent Platinum-resistant/Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers",COMPLETED,,PHASE2,78.0,ACTUAL,Yale University,,2.0,,,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,OTHER,,,,,,,2022,1.0
NCT05048719,,2021-09-13,2023-09-28,,2023-09-28,2021-09-13,2021-09-17,ACTUAL,2023-09-28,2023-10-17,ACTUAL,,,,2023-09-28,2023-10-17,ACTUAL,2021-09-15,ACTUAL,2021-09-15,2023-09,2023-09-30,2022-09-30,ACTUAL,2022-09-30,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,,All randomized participants who received at least one dose of study drug.,A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus,A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo and Once-Weekly Dulaglutide in Participants With Type 2 Diabetes Mellitus,COMPLETED,,PHASE2,383.0,ACTUAL,Eli Lilly and Company,,9.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,INDUSTRY,,,,,,,2022,1.0
NCT04330872,,2020-03-23,,,2020-03-30,2020-03-30,2020-04-02,ACTUAL,,,,,,,2020-03-30,2020-04-02,ACTUAL,2019-08-26,ACTUAL,2019-08-26,2020-03,2020-03-31,2020-03-04,ACTUAL,2020-03-04,2020-01-04,ACTUAL,2020-01-04,,INTERVENTIONAL,ECASIS,,An Investigation Into The Impact Of Enteric Coated Of Aspirin In Patients With Newly Diagnosed Ischemic Stroke.,An Investigation Into The Impact Of Enteric Coated Of Aspirin In Patients With Newly Diagnosed Ischemic Stroke. Non-randomized Interventional Controlled Clinical Trial.,COMPLETED,,PHASE4,42.0,ACTUAL,Hamad Medical Corporation,,2.0,,,f,,,,,f,f,,,f,,,,,,,,2024-10-17 02:11:49.720005,2024-10-17 02:11:49.720005,INDUSTRY,,,,,,,2020,0.0
NCT02516670,,2015-08-04,2022-07-11,,2023-06-05,2015-08-04,2015-08-06,ESTIMATED,2022-07-11,2022-08-08,ACTUAL,,,,2023-06-05,2023-06-07,ACTUAL,2016-06-20,ACTUAL,2016-06-20,2023-06,2023-06-30,2021-10-14,ACTUAL,2021-10-14,2021-07-31,ACTUAL,2021-07-31,,INTERVENTIONAL,,,Docetaxel With or Without Ascorbic Acid in Treating Patients With Metastatic Prostate Cancer,A Randomized Phase 2 Trial of Ascorbic Acid in Combination With Docetaxel in Men With Metastatic Prostate Cancer,TERMINATED,,PHASE2,50.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,2.0,,insufficient clinical response per DSMB,f,,,,t,,,,,,,,,,,,,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,OTHER,,,,,,,2021,0.0
NCT05156827,,2021-12-01,,,2024-01-10,2021-12-01,2021-12-14,ACTUAL,,,,,,,2024-01-10,2024-01-12,ACTUAL,2022-07-26,ACTUAL,2022-07-26,2024-01,2024-01-31,2023-12-18,ACTUAL,2023-12-18,2023-12-18,ACTUAL,2023-12-18,,INTERVENTIONAL,,,"A Study to Assess the Efficacy, Safety, and Pharmacokinetics of TB006 in Participants With Acute Ischemic Stroke","A Phase 2 Double-blind, Randomized, Multi-center, Parallel-group Study to Assess the Efficacy, Safety, and Pharmacokinetics of TB006 in Patients With Acute Ischemic Stroke",WITHDRAWN,,PHASE2,0.0,ACTUAL,"TrueBinding, Inc.",,2.0,,Business decision,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,INDUSTRY,,,,,,,2023,0.0
NCT05039359,,2021-08-09,,,2023-10-26,2021-09-02,2021-09-09,ACTUAL,,,,,,,2023-10-26,2023-10-30,ACTUAL,2022-04-26,ACTUAL,2022-04-26,2023-10,2023-10-31,2023-05-22,ACTUAL,2023-05-22,2023-05-22,ACTUAL,2023-05-22,,INTERVENTIONAL,RESTORE-1,,"Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation to Sinus Rhythm",TERMINATED,,PHASE3,54.0,ACTUAL,"InCarda Therapeutics, Inc.",,2.0,,Limited efficacy upon blinded review,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,INDUSTRY,,,,,,,2023,0.0
NCT03544073,,2018-05-21,,,2019-04-12,2018-05-31,2018-06-01,ACTUAL,,,,,,,2019-04-12,2019-04-16,ACTUAL,2019-04-15,ESTIMATED,2019-04-15,2019-04,2019-04-30,2021-06-30,ESTIMATED,2021-06-30,2020-06-30,ESTIMATED,2020-06-30,,INTERVENTIONAL,GRAET,,GnRH Agonist at Embryo Transfer: IVF Outcomes,Does a GnRH Agonist Given at Embryo Transfer Improve Clinical Pregnancy and Live Birth Rates of Women Undergoing In-Vitro Fertilization?,WITHDRAWN,,PHASE3,0.0,ACTUAL,Maimonides Medical Center,,2.0,,The investigators were not able to get grant funding for this study.,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,OTHER,,,,,,,2021,0.0
NCT04557280,,2020-09-07,,,2022-11-15,2020-09-15,2020-09-21,ACTUAL,,,,,,,2022-11-15,2022-11-16,ACTUAL,2020-11-06,ACTUAL,2020-11-06,2022-11,2022-11-30,2020-12-19,ACTUAL,2020-12-19,2020-12-19,ACTUAL,2020-12-19,,INTERVENTIONAL,,,A Comparative Study of Selatogrel (ACT-246475) Formulations in Healthy Subjects,"A Randomized, Open-label, 3-period Cross-over Study to Assess the Pharmacokinetics of Selatogrel (ACT-246475) in Healthy Subjects After Subcutaneous Administration by Syringe and Auto-injector",COMPLETED,,PHASE1,24.0,ACTUAL,Idorsia Pharmaceuticals Ltd.,,3.0,,,f,,,,f,t,t,t,,,,,,,,NO,,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,INDUSTRY,,,,,,,2020,1.0
NCT05079360,,2021-10-01,,,2023-03-22,2021-10-01,2021-10-15,ACTUAL,,,,,,,2023-03-22,2023-03-24,ACTUAL,2023-03-15,ESTIMATED,2023-03-15,2023-03,2023-03-31,2024-05-26,ESTIMATED,2024-05-26,2024-03-30,ESTIMATED,2024-03-30,,INTERVENTIONAL,,,Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer,"P2 Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- MBC in Patients Who Have Shown Previous Disease Progression on a Nonsteroidal Aromatase Inhibitor, Fulvestrant and CDK 4/6 Inhibitor",WITHDRAWN,,PHASE2,0.0,ACTUAL,Veru Inc.,,2.0,,Decided to halt and will potentially reopen in the future.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,INDUSTRY,,,,,,,2024,0.0
NCT01300728,,2011-02-22,2015-08-08,,2022-10-25,2011-02-22,2011-02-23,ESTIMATED,2016-03-01,2016-03-31,ESTIMATED,,,,2022-10-25,2022-10-27,ACTUAL,2011-01-01,ACTUAL,2011-01-01,2022-07,2022-07-31,2020-03-12,ACTUAL,2020-03-12,2020-03-12,ACTUAL,2020-03-12,,INTERVENTIONAL,MCI,,Study of Intravenous Immunoglobulin in Amnestic Mild Cognitive Impairment,A Randomized Double-Blinded Placebo-Controlled Exploratory Study of Intravenous Immunoglobulin (NewGam 10%) in Amnestic Mild Cognitive Impairment,COMPLETED,,PHASE2,52.0,ACTUAL,Sutter Health,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,OTHER,,,,,,,2020,0.0
NCT04655599,,2020-11-19,,,2021-05-13,2020-12-04,2020-12-07,ACTUAL,,,,,,,2021-05-13,2021-05-17,ACTUAL,2021-01-29,ACTUAL,2021-01-29,2021-05,2021-05-31,2021-04-13,ACTUAL,2021-04-13,2021-04-13,ACTUAL,2021-04-13,,INTERVENTIONAL,,,Effect of Olorinab on Gastrointestinal Transit in Patients With Irritable Bowel Syndrome,Effect of Olorinab on Gastrointestinal Transit in Patients With Irritable Bowel Syndrome,TERMINATED,,PHASE1,1.0,ACTUAL,Arena Pharmaceuticals,,2.0,,Strategic business decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,INDUSTRY,,,,,,,2021,0.0
NCT03256045,,2017-08-16,2022-02-01,,2022-05-06,2017-08-16,2017-08-21,ACTUAL,2022-05-06,2022-05-09,ACTUAL,,,,2022-05-06,2022-05-09,ACTUAL,2018-02-08,ACTUAL,2018-02-08,2022-05,2022-05-31,2021-02-05,ACTUAL,2021-02-05,2021-02-05,ACTUAL,2021-02-05,,INTERVENTIONAL,,,"Panobinostat, Carfilzomib, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma",CLBH589DUS108T: Panobinostat With Carfilzomib and Dexamethasone for Relapsed/Refractory Multiple Myeloma: Correlation With In Vitro Chemosensitivity Testing,TERMINATED,,PHASE2,9.0,ACTUAL,University of Washington,"Study was limited by lower accrual than expected due to: competing studies, other investigators' treatment preferences, and ultimately, the departure of the initial PI from the institution. Because of PI's departure and lab closure, the study closed to accrual after the 9th patient enrolled. Because only 9 subjects were enrolled and some in-vitro assay results are unavailable, it is difficult to analyze the in-vitro assay results and determine the parameters that predict disease response.",1.0,,Terminated due to loss of funding and former PI left the institution,f,,,,t,t,f,,,,,,,,,,,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,OTHER,,,,,,,2021,0.0
NCT04001413,,2019-06-26,,,2022-07-28,2019-06-26,2019-06-28,ACTUAL,,,,,,,2022-07-28,2022-07-29,ACTUAL,2019-09-17,ACTUAL,2019-09-17,2022-07,2022-07-31,2021-03-25,ACTUAL,2021-03-25,2021-03-25,ACTUAL,2021-03-25,,INTERVENTIONAL,,,Therapy for High-Risk HPV 16-Positive Oropharynx Cancer Patients,"Phase II, Adjuvant Therapy for High-Risk HPV 16-Positive Oropharynx Cancer Patients With Durvalumab (MEDI4736) and MEDI0457 (INO-3112)",WITHDRAWN,,PHASE2,0.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,3.0,,Sponsor withdrew funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,OTHER,,,,,,,2021,0.0
NCT03016312,,2017-01-09,2021-04-05,,2024-08-08,2017-01-09,2017-01-10,ESTIMATED,2021-04-05,2021-04-30,ACTUAL,,,,2024-08-08,2024-08-09,ACTUAL,2017-01-10,ACTUAL,2017-01-10,2024-08,2024-08-31,2022-12-20,ACTUAL,2022-12-20,2019-06-24,ACTUAL,2019-06-24,,INTERVENTIONAL,IMbassador250,Total randomised participants 759.,"A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen","A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor and Failure of, Ineligibility for, or Refusal of a Taxane Regimen",COMPLETED,,PHASE3,759.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,INDUSTRY,,,,,,,2022,1.0
NCT02485691,,2015-06-26,2021-11-12,,2022-05-03,2015-06-26,2015-06-30,ESTIMATED,2022-02-11,2022-02-14,ACTUAL,,,,2022-05-03,2022-05-27,ACTUAL,2015-11-09,ACTUAL,2015-11-09,2022-05,2022-05-31,2021-03-15,ACTUAL,2021-03-15,2019-03-27,ACTUAL,2019-03-27,,INTERVENTIONAL,CARD,"Analysis was performed on Intent-to-treat (ITT) population, that included any participant who had been allocated to a randomized treatment regardless of whether the treatment kit was used, analyzed according to the treatment group allocated by randomization.",Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent,"A Randomized, Open Label, Multicenter Study of Cabazitaxel Versus an Androgen Receptor (AR)-Targeted Agent (Abiraterone or Enzalutamide) in mCRPC Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent (CARD)",COMPLETED,,PHASE4,255.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,,,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,INDUSTRY,,,,,,,2021,1.0
NCT03575104,,2018-05-17,2022-01-07,2020-10-20,2022-03-24,2018-06-20,2018-07-02,ACTUAL,2022-03-24,2022-03-25,ACTUAL,2022-03-24,2022-03-25,ACTUAL,2022-03-24,2022-03-25,ACTUAL,2018-05-29,ACTUAL,2018-05-29,2022-03,2022-03-31,2020-05-14,ACTUAL,2020-05-14,2020-04-09,ACTUAL,2020-04-09,,INTERVENTIONAL,,,Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep,"Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder",COMPLETED,,PHASE3,924.0,ACTUAL,Idorsia Pharmaceuticals Ltd.,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,INDUSTRY,,,,,,,2020,1.0
NCT03282760,,2017-08-09,,,2021-07-09,2017-09-12,2017-09-14,ACTUAL,,,,,,,2021-07-09,2021-07-12,ACTUAL,2017-09-09,ACTUAL,2017-09-09,2021-07,2021-07-31,2021-05-29,ACTUAL,2021-05-29,2021-05-29,ACTUAL,2021-05-29,,INTERVENTIONAL,NSC-SPMS,,Safety Study of Human Neural Stem Cells Injections for Secondary Progressive Multiple Sclerosis Patients,"A Phase I Multicenter Study of Allogenic, Intracerebroventricular Human Neural Stem Cells Transplantation for the Experimental Treatment of Secondary Progressive Multiple Sclerosis Patients",COMPLETED,,PHASE1,24.0,ACTUAL,Casa Sollievo della Sofferenza IRCCS,,1.0,,,f,,,,t,f,f,,,,,,,,,YES,All IPD that underlie results in a publication,2024-10-16 05:11:08.672132,2024-10-16 05:11:08.672132,OTHER,,,,,,,2021,1.0
NCT02760615,,2016-05-02,,,2020-10-23,2016-05-02,2016-05-03,ESTIMATED,,,,,,,2020-10-23,2020-10-27,ACTUAL,2016-11-01,ESTIMATED,2016-11-01,2020-10,2020-10-31,2020-08-01,ESTIMATED,2020-08-01,2020-08-01,ESTIMATED,2020-08-01,,INTERVENTIONAL,,,"Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study","An Open-Label, 2-Part, Multicenter, Post-marketing Study to Evaluate the Effect of Moderately or Severely Active Ulcerative Colitis or Crohn's Disease on Cytochrome P-450 Enzyme Substrates Compared to Healthy Subjects and the Effect of Vedolizumab Treatment on Cytochrome P-450 Enzyme Substrates in Subjects With Ulcerative Colitis or Crohn's Disease",WITHDRAWN,,PHASE4,0.0,ACTUAL,Takeda,,3.0,,No enrollment,f,,,,f,t,f,,,,,,,,,,,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,INDUSTRY,,,,,,,2020,0.0
NCT03402178,,2018-01-10,,,2021-06-29,2018-01-10,2018-01-18,ACTUAL,,,,,,,2021-06-29,2021-06-30,ACTUAL,2017-12-21,ACTUAL,2017-12-21,2021-06,2021-06-30,2020-02-20,ACTUAL,2020-02-20,2020-02-20,ACTUAL,2020-02-20,,INTERVENTIONAL,,,"Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2082 in Healthy Male Subjects","A Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Studies to Assess the Safety, Tolerability, and Pharmacokinetics of E2082 in Healthy Male Subjects",TERMINATED,,PHASE1,118.0,ACTUAL,Eisai Inc.,,2.0,,Safety Review,f,,,,f,f,f,,,,,,,,,,,2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,INDUSTRY,,,,,,,2020,0.0
NCT05259917,,2022-02-04,2024-06-12,,2024-07-16,2022-02-28,2022-03-02,ACTUAL,2024-07-16,2024-07-19,ACTUAL,,,,2024-07-16,2024-07-19,ACTUAL,2022-02-22,ACTUAL,2022-02-22,2024-01,2024-01-31,2023-12-31,ACTUAL,2023-12-31,2023-12-31,ACTUAL,2023-12-31,,INTERVENTIONAL,,,"A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)","A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema Type I or II",COMPLETED,,PHASE3,136.0,ACTUAL,"KalVista Pharmaceuticals, Ltd.",,3.0,,,f,,,,,t,f,,,,,,,,,NO,Data will not be shared until all global regulatory filings are complete,2024-10-17 02:11:49.720005,2024-10-17 02:11:49.720005,INDUSTRY,,,,,,,2023,1.0
NCT04322227,,2020-01-29,,,2020-07-03,2020-03-25,2020-03-26,ACTUAL,,,,,,,2020-07-03,2020-07-07,ACTUAL,2020-01-23,ACTUAL,2020-01-23,2020-07,2020-07-31,2020-05-30,ACTUAL,2020-05-30,2020-05-30,ACTUAL,2020-05-30,,INTERVENTIONAL,,,Study Investigating Effects of Foliglurax in Patients With Parkinson's Disease (PD) and Healthy Subjects,"Interventional, Randomized, Double-blind, Placebo-controlled Three-way Crossover Study Investigating the Pharmacodynamic Effects of Two Doses of Foliglurax Using Electroencephalography in Patients With Parkinson's Disease and in Healthy Subjects",TERMINATED,,PHASE1,6.0,ACTUAL,H. Lundbeck A/S,,2.0,,Study termination due to efficacy results of another study,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,INDUSTRY,,,,,,,2020,0.0
NCT03095287,,2017-03-23,2021-09-16,,2021-10-27,2017-03-23,2017-03-29,ACTUAL,2021-10-27,2021-11-23,ACTUAL,,,,2021-10-27,2021-11-23,ACTUAL,2018-01-03,ACTUAL,2018-01-03,2021-10,2021-10-31,2020-09-18,ACTUAL,2020-09-18,2020-09-18,ACTUAL,2020-09-18,,INTERVENTIONAL,,All enrolled participants.,Alphanate in Immune Tolerance Induction Therapy,"A Multicenter Phase 2 Open-Label, Single-Arm, Prospective, Interventional Study of Plasma-Derived Factor VIII/VWF (Alphanate®) in Immune Tolerance Induction Therapy in Subjects With Congenital Hemophilia A",TERMINATED,,PHASE2,2.0,ACTUAL,Grifols Therapeutics LLC,,1.0,,Terminated due to limited enrollment (non-safety related decision),f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 02:11:49.720005,2024-10-17 02:11:49.720005,INDUSTRY,,,,,,,2020,0.0
NCT01571791,,2012-03-31,,,2020-09-02,2012-04-04,2012-04-05,ESTIMATED,,,,,,,2020-09-02,2020-09-04,ACTUAL,2012-06,,2012-06-30,2020-09,2020-09-30,2022-03,ESTIMATED,2022-03-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Perioperative Ketorolac-lidocaine in the Patients With Valvular Heart Diseases During Cesarean Delivery,A Randomized Study of the Effects of Perioperative i.v. Ketorolac-lidocaine on the Hemodynamic Response in the Patients With Valvular Heart Diseases During Cesarean Delivery,SUSPENDED,,PHASE2,90.0,ESTIMATED,Mansoura University,,2.0,,No enough recruited cases,f,,,,t,,,,,,,,,,,,,2024-10-17 02:11:49.720005,2024-10-17 02:11:49.720005,OTHER,,,,,,,2022,0.0
NCT02464059,,2015-06-03,2020-07-02,,2020-07-22,2015-06-04,2015-06-08,ESTIMATED,2020-07-22,2020-07-24,ACTUAL,,,,2020-07-22,2020-07-24,ACTUAL,2015-11-10,ACTUAL,2015-11-10,2020-04,2020-04-30,2020-04-15,ACTUAL,2020-04-15,2020-04-15,ACTUAL,2020-04-15,,INTERVENTIONAL,,,Cathelicidin and Vitamin D: Impact on Populations At-Risk and With COPD,Cathelicidin and Vitamin D: Impact on Populations At-Risk and With COPD,COMPLETED,,PHASE2,23.0,ACTUAL,"University of North Carolina, Chapel Hill",Study enrollment did not achieve targeted sample size enrollment during the time frame of the funding award.,1.0,,,f,,,,f,,,,,,,,,,,NO,Individual participant data will not be made publicly available,2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,OTHER,,,,,,,2020,1.0
NCT05019105,,2021-08-16,,,2022-08-31,2021-08-20,2021-08-24,ACTUAL,,,,,,,2022-08-31,2022-09-02,ACTUAL,2021-10-13,ACTUAL,2021-10-13,2022-08,2022-08-31,2022-08-23,ACTUAL,2022-08-23,2022-08-23,ACTUAL,2022-08-23,,INTERVENTIONAL,,,Phase 1 ALKS 1140 in Healthy Adults,"A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Escalating Doses of ALKS 1140 With a Pilot Evaluation of Food Effect in Healthy Adult Subjects",TERMINATED,,PHASE1,20.0,ACTUAL,"Alkermes, Inc.",,2.0,,Sponsor Decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,INDUSTRY,,,,,,,2022,0.0
NCT04416048,,2020-06-02,,,2021-12-23,2020-06-03,2020-06-04,ACTUAL,,,,,,,2021-12-23,2022-01-12,ACTUAL,2020-11-30,ACTUAL,2020-11-30,2021-12,2021-12-31,2021-07-20,ACTUAL,2021-07-20,2021-07-20,ACTUAL,2021-07-20,,INTERVENTIONAL,COVID-PREVENT,,Effect of Anticoagulation Therapy on Clinical Outcomes in COVID-19,Effect of Anticoagulation Therapy on Clinical Outcomes in Moderate to Severe Coronavirus Disease 2019 (COVID-19),TERMINATED,,PHASE2,111.0,ACTUAL,"Charite University, Berlin, Germany",,2.0,,Due to lower COVID-19 cases and therefore difficulties with the recruitment.,f,,,,t,f,f,,,,,,,,,YES,after protection period,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,OTHER,,,,,,,2021,0.0
NCT04360421,,2020-04-20,,,2023-08-18,2020-04-21,2020-04-24,ACTUAL,,,,,,,2023-08-18,2023-08-22,ACTUAL,2020-04-21,ACTUAL,2020-04-21,2023-08,2023-08-31,2023-08-01,ACTUAL,2023-08-01,2023-08-01,ACTUAL,2023-08-01,,INTERVENTIONAL,,,Use of Long-acting Bupivacaine In Lower Extremity Amputation,Use of Liposomal Bupivacaine (Exparel) In Expedited Recovery Following Lower Extremity Amputation,TERMINATED,,PHASE4,7.0,ACTUAL,Loma Linda University,,1.0,,PI left institution,f,,,,,t,f,,,t,,,,,,NO,,2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,OTHER,,,,,,,2023,0.0
NCT03543410,,2018-05-21,2023-04-03,2021-04-06,2023-04-24,2018-05-21,2018-06-01,ACTUAL,2023-04-24,2023-05-18,ACTUAL,,2023-05-18,ACTUAL,2023-04-24,2023-05-18,ACTUAL,2018-06-26,ACTUAL,2018-06-26,2023-04,2023-04-30,2020-04-23,ACTUAL,2020-04-23,2020-04-23,ACTUAL,2020-04-23,,INTERVENTIONAL,,,A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression,"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of SEP-4199 for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)",COMPLETED,,PHASE2,344.0,ACTUAL,"Sumitomo Pharma America, Inc.",,3.0,,,f,,,,t,t,f,,,,,,IPD will be made available upon request within 12 months of posting the study results on ct.gov.,"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://vivli.org,YES,IPD for this study may be made available upon request via the Vivli Center for Global Clinical Research Data website.,2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,INDUSTRY,,,,,,,2020,1.0
NCT03736967,,2018-11-07,2021-10-01,2021-03-12,2021-10-01,2018-11-07,2018-11-09,ACTUAL,2021-10-01,2021-11-01,ACTUAL,2021-03-18,2021-03-22,ACTUAL,2021-10-01,2021-11-01,ACTUAL,2018-11-12,ACTUAL,2018-11-12,2021-10,2021-10-31,2020-07-28,ACTUAL,2020-07-28,2020-03-13,ACTUAL,2020-03-13,,INTERVENTIONAL,,,Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis,"A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis",TERMINATED,,PHASE2,206.0,ACTUAL,Regeneron Pharmaceuticals,"The decision was made by the sponsor to terminate the study on 12 Feb 2020 due to lack of efficacy. Study enrollment was not complete at that time, therefore planned sample sizes were not met. Participants discontinued study drug and transitioned into the post-treatment follow-up period. As a result of the decision to terminate the study, all statistical analyses were descriptive and no hypothesis testing was performed.",4.0,,Lack of efficacy,f,,,,t,t,f,,,,,,,,,,,2024-10-17 02:11:49.720005,2024-10-17 02:11:49.720005,INDUSTRY,,,,,,,2020,0.0
NCT03378063,,2017-12-06,,,2023-04-28,2017-12-17,2017-12-19,ACTUAL,,,,,,,2023-04-28,2023-05-01,ACTUAL,2017-11-01,ACTUAL,2017-11-01,2021-02,2021-02-28,2022-12-30,ESTIMATED,2022-12-30,2022-12-30,ESTIMATED,2022-12-30,,INTERVENTIONAL,,,Stem Cells for Bronchopulmonary Dysplasia,Stem Cells for Bronchopulmonary Dysplasia: a Cohort Study,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Daping Hospital and the Research Institute of Surgery of the Third Military Medical University,,2.0,,no stell cell accessed,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,OTHER,,,,,,,2022,0.0
NCT05242029,,2022-02-07,,,2024-01-31,2022-02-07,2022-02-16,ACTUAL,,,,,,,2024-01-31,2024-02-02,ACTUAL,2023-12,ESTIMATED,2023-12-31,2024-01,2024-01-31,2024-12,ESTIMATED,2024-12-31,2024-02,ESTIMATED,2024-02-29,,INTERVENTIONAL,,,Psilocybin for Opioid Use Disorder in Patients on Methadone Maintenance With Ongoing Opioid Use,"A Randomized, Double-Blind Study of Psilocybin for Opioid Use Disorder in Patients on Methadone Maintenance With Ongoing Opioid Use",WITHDRAWN,,PHASE2,0.0,ACTUAL,Johns Hopkins University,,2.0,,Lack of funding,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,OTHER,,,,,,,2024,0.0
NCT04612725,,2020-09-18,2023-10-10,,2024-03-12,2020-10-27,2020-11-03,ACTUAL,2024-03-12,2024-03-13,ACTUAL,,,,2024-03-12,2024-03-13,ACTUAL,2020-10-27,ACTUAL,2020-10-27,2024-03,2024-03-31,2023-03-28,ACTUAL,2023-03-28,2022-10-13,ACTUAL,2022-10-13,,INTERVENTIONAL,ARROYO,"The full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study.",A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO),"A Phase 2b Multinational, Randomised, Double-blind, Parallel- Group, 24-week Placebo-controlled Study With 28-week Extension to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)",TERMINATED,,PHASE2,159.0,ACTUAL,AstraZeneca,The study was terminated early by the sponsor as the primary analysis results did not support the continued development of benralizumab for the indication of CSU.,5.0,,Study did not meet primary endpoint,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,INDUSTRY,,,,,,,2023,0.0
NCT03573323,,2018-06-20,2020-07-10,,2020-07-10,2018-06-20,2018-06-29,ACTUAL,2020-07-10,2020-07-28,ACTUAL,,,,2020-07-10,2020-07-28,ACTUAL,2018-11-09,ACTUAL,2018-11-09,2020-02,2020-02-29,2020-01-08,ACTUAL,2020-01-08,2019-07-15,ACTUAL,2019-07-15,,INTERVENTIONAL,IXORA-R,All randomized participants.,A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis,"A 24-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Guselkumab in Patients With Moderate-to-Severe Plaque Psoriasis",COMPLETED,,PHASE4,1027.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org,YES,Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,INDUSTRY,,,,,,,2020,1.0
NCT04729725,,2020-11-30,,,2023-08-08,2021-01-27,2021-01-28,ACTUAL,,,,,,,2023-08-08,2023-08-14,ACTUAL,2021-02-09,ACTUAL,2021-02-09,2023-08,2023-08-31,2022-12-02,ACTUAL,2022-12-02,2022-12-02,ACTUAL,2022-12-02,,INTERVENTIONAL,,,"SAR439459 and Cemiplimab for the Treatment of Advanced or Unresectable Solid Tumors, Strategic Alliance, TACTIC TRIAL",Strategic Alliance: Phase 1b Trial Assessing Combination of TGF-β Inhibitor and PD-1 Inhibitor Cemiplimab,TERMINATED,,PHASE1,3.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,"The industry supporter discontinued the study and lead drug, SAR439459, due to toxicity.",,,,,f,t,f,,,,,,,,,,,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,OTHER,,,,,,,2022,0.0
NCT03794596,,2018-11-22,,,2019-07-19,2019-01-04,2019-01-07,ACTUAL,,,,,,,2019-07-19,2019-07-22,ACTUAL,2019-09,ESTIMATED,2019-09-30,2019-07,2019-07-31,2021-02-28,ESTIMATED,2021-02-28,2021-02-28,ESTIMATED,2021-02-28,,INTERVENTIONAL,IMpALA,,"A Proof of Concept, Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer","A Proof of Concept, Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer",WITHDRAWN,,PHASE2,0.0,ACTUAL,The Christie NHS Foundation Trust,,2.0,,IP breach,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-17 02:11:49.720005,2024-10-17 02:11:49.720005,OTHER,,,,,,,2021,0.0
NCT02530931,,2015-08-18,,,2020-11-16,2015-08-20,2015-08-21,ESTIMATED,,,,,,,2020-11-16,2020-11-18,ACTUAL,2016-03-16,ACTUAL,2016-03-16,2020-11,2020-11-30,2020-09,ACTUAL,2020-09-30,2020-09,ACTUAL,2020-09-30,,INTERVENTIONAL,PROSPER,,Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease,Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease,TERMINATED,,PHASE4,23.0,ACTUAL,"University Hospital, Grenoble",,1.0,,Recruitment problem-covid,f,,,,f,,,,,,,,,,,,,2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,OTHER,,,,,,,2020,0.0
NCT04415073,,2020-05-29,2022-06-29,,2022-06-29,2020-06-02,2020-06-04,ACTUAL,2022-06-29,2022-07-22,ACTUAL,,,,2022-06-29,2022-07-22,ACTUAL,2020-05-30,ACTUAL,2020-05-30,2022-06,2022-06-30,2020-07-13,ACTUAL,2020-07-13,2020-07-13,ACTUAL,2020-07-13,,INTERVENTIONAL,,"This study was terminated by the Sponsor. Due to study termination and only 1 participant being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.",A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19,"A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Axatilimab for the Treatment of Hospitalized Patients With Respiratory Signs and Symptoms Secondary to Novel Coronavirus Disease (COVID-19)",TERMINATED,,PHASE2,1.0,ACTUAL,Syndax Pharmaceuticals,"This study was terminated by the Sponsor given enrollment challenges, partly attributable to the constantly changing COVID-19 treatment landscape. Due to study termination and only 1 participant being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.",2.0,,"Given enrollment challenges, partly attributable to the constantly changing COVID-19 treatment landscape, the trial has been closed.",,,,,t,t,f,,,,,,,,,,,2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,INDUSTRY,,,,,,,2020,0.0
NCT04400318,,2020-05-21,2024-06-18,,2024-06-18,2020-05-21,2020-05-22,ACTUAL,2024-06-18,2024-07-10,ACTUAL,,,,2024-06-18,2024-07-10,ACTUAL,2020-06-20,ACTUAL,2020-06-20,2024-06,2024-06-30,2023-08-21,ACTUAL,2023-08-21,2023-06-26,ACTUAL,2023-06-26,,INTERVENTIONAL,VESTIGE,"The Intent-to-Treat (ITT) analysis set consisted of randomized participant (participant with a study intervention kit number allocated and recorded in the interactive voice recognition system \[IVRS\]/ interactive web response system \[IWRS\] database, regardless of whether the study intervention kit was used or not).",The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma,"Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Lung Function, Mucus Plugging and Other Lung Imaging Parameters in Patients With Asthma",COMPLETED,,PHASE4,109.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-17 02:11:49.720005,2024-10-17 02:11:49.720005,INDUSTRY,,,,,,,2023,1.0
NCT03315741,,2017-10-05,,,2022-06-08,2017-10-16,2017-10-20,ACTUAL,,,,,,,2022-06-08,2022-06-13,ACTUAL,2018-03-01,ACTUAL,2018-03-01,2022-06,2022-06-30,2022-04-27,ACTUAL,2022-04-27,2022-02-27,ACTUAL,2022-02-27,,INTERVENTIONAL,STOP-BOS,,The Safety and Tolerability of Pirfenidone for BOS After HCT,The Safety and Tolerability of Pirfenidone for Bronchiolitis Obliterans Syndrome After Hematopoietic Cell Transplantation,COMPLETED,,PHASE1,30.0,ACTUAL,Stanford University,,1.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,OTHER,,,,,,,2022,1.0
NCT03372941,,2017-12-04,2022-09-23,,2022-11-11,2017-12-08,2017-12-14,ACTUAL,2022-11-11,2022-12-09,ACTUAL,,,,2022-11-11,2022-12-09,ACTUAL,2019-03-04,ACTUAL,2019-03-04,2022-11,2022-11-30,2021-10-14,ACTUAL,2021-10-14,2021-10-14,ACTUAL,2021-10-14,,INTERVENTIONAL,,,Hospital Avoidance Strategies for ABSSSI,Hospital Avoidance Strategies for Treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI),TERMINATED,,PHASE4,11.0,ACTUAL,Washington University School of Medicine,,2.0,,Funding and recruitment limited by pandemic,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,OTHER,,,,,,,2021,0.0
NCT04201080,,2019-12-05,,,2021-09-20,2019-12-12,2019-12-17,ACTUAL,,,,,,,2021-09-20,2021-09-22,ACTUAL,2019-11-11,ACTUAL,2019-11-11,2021-09,2021-09-30,2020-08-10,ACTUAL,2020-08-10,2020-02-17,ACTUAL,2020-02-17,,INTERVENTIONAL,,,"A Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous TRV250","A Phase 1, Two-part, Single Dose, Randomised, Double-blind, Placebo-controlled Parallel Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Subcutaneous TRV250 Following Glyceryl Trinitrate Infusion",TERMINATED,,PHASE1,9.0,ACTUAL,Trevena Inc.,,6.0,,Because there have been significant enrollment struggles which has been exacerbated by the COVID impact. This has caused an undue delay to the study timelines and its enrollment goals beyond the business needs.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,INDUSTRY,,,,,,,2020,0.0
NCT05890768,,2023-02-22,,,2024-06-10,2023-05-25,2023-06-06,ACTUAL,,,,,,,2024-06-10,2024-06-12,ACTUAL,2023-05-11,ACTUAL,2023-05-11,2024-06,2024-06-30,2024-02-28,ACTUAL,2024-02-28,2024-02-28,ACTUAL,2024-02-28,,INTERVENTIONAL,Lumafep,,Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine,The Relationship Between the Efficacy of Lumateperone and Central Glutamate and Dopaminergic Metabolism: A Comparison With Risperidone in First Episode Psychosis,TERMINATED,,PHASE4,5.0,ACTUAL,University of New Mexico,,2.0,,PI was unable to meet 1 year recruitment goal,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,OTHER,,,,,,,2024,0.0
NCT05170451,,2021-12-10,,,2024-02-23,2021-12-10,2021-12-28,ACTUAL,,,,,,,2024-02-23,2024-02-28,ACTUAL,2022-01,ESTIMATED,2022-01-31,2024-02,2024-02-29,2022-12,ESTIMATED,2022-12-31,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,Topical CBD for Musculoskeletal Pain,A Randomized Controlled Trial of Topical Cannabidiol for the Treatment of Musculoskeletal Pain,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,University of Virginia,,2.0,,Terminated due to hurdles of obtaining regulatory approval.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,OTHER,,,,,,,2022,0.0
NCT03706053,,2018-09-26,,,2022-02-17,2018-10-11,2018-10-15,ACTUAL,,,,,,,2022-02-17,2022-03-04,ACTUAL,2018-11-05,ACTUAL,2018-11-05,2022-02,2022-02-28,2022-02-11,ACTUAL,2022-02-11,2022-02-11,ACTUAL,2022-02-11,,INTERVENTIONAL,,,Midodrine Use in Septic Shock,Midodrine Use for Hypotension Requiring IV Vasopressor Therapy in Early Septic Shock,TERMINATED,,PHASE3,10.0,ACTUAL,University of Virginia,,3.0,,No funding for the study; not enough staff,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,OTHER,,,,,,,2022,0.0
NCT03183128,,2017-06-08,2023-03-07,2021-06-21,2023-04-06,2017-06-08,2017-06-09,ACTUAL,2023-04-06,2023-04-27,ACTUAL,,2023-04-27,ACTUAL,2023-04-06,2023-04-27,ACTUAL,2017-07-10,ACTUAL,2017-07-10,2021-06,2021-06-30,2020-09-29,ACTUAL,2020-09-29,2020-07-03,ACTUAL,2020-07-03,,INTERVENTIONAL,ECOSPORIII,,ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection,"A Phase 3 Multicenter, RandomizeEd, Double Blind, Placebo COntrolled, Parallel Group Study to Evaluate the Safety, Tolerability, & Efficacy of SER-109 vs. Placebo to Reduce Recurrence of ClOstRidium Difficile Infection (CDI) in Adults",COMPLETED,,PHASE3,182.0,ACTUAL,"Seres Therapeutics, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,INDUSTRY,,,,,,,2020,1.0
NCT03452566,,2018-02-26,,,2019-06-17,2018-02-26,2018-03-02,ACTUAL,,,,,,,2019-06-17,2019-06-19,ACTUAL,2020-02,ESTIMATED,2020-02-29,2019-06,2019-06-30,2022-04,ESTIMATED,2022-04-30,2021-09,ESTIMATED,2021-09-30,,INTERVENTIONAL,EIMAC,,Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment,Phase 1/2 Clinical Trial for the Evaluation of Ingenol Mebutate for Actinic Cheilitis,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Instituto Nacional de Cancer, Brazil",,1.0,,Ingenol mebutato discontinued in Brazil.,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,OTHER_GOV,,,,,,,2022,0.0
NCT02642094,,2015-11-25,2023-07-17,,2023-12-03,2015-12-29,2015-12-30,ESTIMATED,2023-12-03,2023-12-05,ACTUAL,,,,2023-12-03,2023-12-05,ACTUAL,2016-07,ACTUAL,2016-07-31,2023-12,2023-12-31,2022-05-01,ACTUAL,2022-05-01,2022-03-01,ACTUAL,2022-03-01,,INTERVENTIONAL,,"This was a non-random, open-label, phase II, window of opportunity trial to investigate a possible inhibition of mammary stem cells (MaSCs) in non-cancerous tissue and/or malignant markers by rapamycin in patients with non-invasive breast cancer. A total of 40 patients agreed to undergo the treatment and 38 successfully completed the regiment. The control group for providing non-cancerous breast tissue included 12 patients with non-invasive breast cancer and 6 with invasive cancer.",Aging Mammary Stem Cells and Breast Cancer Prevention,Aging Mammary Stem Cells and Breast Cancer Prevention,TERMINATED,,PHASE2,58.0,ACTUAL,The University of Texas Health Science Center at San Antonio,Our hypothesis was that a low dose and short term treatment with rapamycin in patients with early stage breast cancer would show significantly attenuation of mammary stem and progenitor cell activity and tumor progression biomarkers in a non-randomized study.,1.0,,The study was terminated early according to the protocol due to efficacy.,f,,,,f,t,,,,,,,,,,,,2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,OTHER,,,,,,,2022,0.0
NCT05496595,,2022-08-09,,,2024-03-04,2022-08-09,2022-08-11,ACTUAL,,,,,,,2024-03-04,2024-03-06,ACTUAL,2022-10-26,ACTUAL,2022-10-26,2024-03,2024-03-31,2024-02-05,ACTUAL,2024-02-05,2024-02-05,ACTUAL,2024-02-05,,INTERVENTIONAL,,,DCBY02 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors,"A Phase 1, Multicenter, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of DCBY02 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors",TERMINATED,,PHASE1,5.0,ACTUAL,DynamiCure Biotechnology,,2.0,,"Review of Data, and our other compound is a better option",,,,,f,t,f,,,,,,,,,NO,,2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,INDUSTRY,,,,,,,2024,0.0
NCT04424901,,2020-05-29,2023-02-24,,2023-04-20,2020-06-08,2020-06-11,ACTUAL,2023-04-20,2023-04-21,ACTUAL,,,,2023-04-20,2023-04-21,ACTUAL,2020-05-03,ACTUAL,2020-05-03,2023-04,2023-04-30,2022-04-24,ACTUAL,2022-04-24,2022-03-22,ACTUAL,2022-03-22,,INTERVENTIONAL,TOLD,,Trial of Open Label Dipyridamole- In Hospitalized Patients With COVID-19,"A Randomized, Open-label Study of the Vascular and Microbiologic Efficacy of Dipyridamole Plus Standard Care vs. Standard Care in Hospitalized COVID19 Patients",TERMINATED,,PHASE2,41.0,ACTUAL,UConn Health,"No data obtained beyond 9 days of enrollment. If discharged from care, phone follow up limited to data provided by subject report, up to day 9.",2.0,,reduction of Hospitalized COVID patients at UConnHealth,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:11:49.720005,2024-10-17 02:11:49.720005,OTHER,,,,,,,2022,0.0
NCT02097732,,2014-03-24,2017-11-14,,2021-04-20,2014-03-24,2014-03-27,ESTIMATED,2017-12-19,2018-01-19,ACTUAL,,,,2021-04-20,2021-05-12,ACTUAL,2014-04,,2014-04-30,2021-04,2021-04-30,2020-07,ACTUAL,2020-07-31,2016-08,ACTUAL,2016-08-31,,INTERVENTIONAL,,,Ipilimumab Induction in Patients With Melanoma Brain Metastases Receiving Stereotactic Radiosurgery,Ipilimumab Induction in Patients With Melanoma Brain Metastases Receiving Stereotactic Radiosurgery,TERMINATED,,PHASE2,4.0,ACTUAL,University of Michigan Rogel Cancer Center,Study halted prematurely due to a change in the standard of care treatment.,2.0,,Study halted prematurely due to a change in the standard of care treatment,f,,,,t,,,,,,,,,,,,,2024-10-17 02:11:49.720005,2024-10-17 02:11:49.720005,OTHER,,,,,,,2020,0.0
NCT02059239,,2014-02-06,2020-12-15,,2021-02-01,2014-02-06,2014-02-11,ESTIMATED,2021-02-01,2021-02-21,ACTUAL,,,,2021-02-01,2021-02-21,ACTUAL,2014-06-04,ACTUAL,2014-06-04,2021-02,2021-02-28,2020-06-15,ACTUAL,2020-06-15,2019-12-16,ACTUAL,2019-12-16,,INTERVENTIONAL,,,Bendamustine Bridge to Autologous or Allogeneic Transplant for Relapsed/Refractory Lymphoma,A Pilot Study of a Sequential Regimen of Intensive Chemotherapy Followed by Autologous or Allogeneic Transplantation for Refractory Lymphoma (Non-Hodgkin's and Hodgkin's) and Phase 2 Expansion Cohort,COMPLETED,,PHASE1/PHASE2,34.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-17 02:11:49.720005,2024-10-17 02:11:49.720005,OTHER,,,,,,,2020,1.0
NCT02341963,,2015-01-12,,,2021-02-24,2015-01-14,2015-01-19,ESTIMATED,,,,,,,2021-02-24,2021-03-01,ACTUAL,2015-01,ACTUAL,2015-01-31,2021-02,2021-02-28,2021-01,ACTUAL,2021-01-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,,,A Pilot Clinical Trial of Oral Ketamine for Acute Pain Management After Amputation Surgery,"A Prospective, Open-Label Pilot Clinical Trial of Oral Ketamine for Acute Pain Management After Amputation Surgery",TERMINATED,,PHASE1,5.0,ACTUAL,Rush University Medical Center,,1.0,,Recruitment issues,f,,,,t,,,,,,,,,,,,,2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,OTHER,,,,,,,2021,0.0
NCT04664153,,2020-12-06,2022-08-01,,2022-08-01,2020-12-06,2020-12-11,ACTUAL,2022-08-01,2022-08-26,ACTUAL,,,,2022-08-01,2022-08-26,ACTUAL,2020-12-21,ACTUAL,2020-12-21,2022-08,2022-08-31,2021-08-18,ACTUAL,2021-08-18,2021-08-18,ACTUAL,2021-08-18,,INTERVENTIONAL,EMPORIA,Baseline analysis population included all participants who received at least 1 dose of study treatment.,"Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis","A PHASE 2A, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07038124 OINTMENT FOR 6 WEEKS IN PARTICIPANTS WITH MILD TO MODERATE ATOPIC DERMATITIS OR PLAQUE PSORIASIS",COMPLETED,,PHASE2,104.0,ACTUAL,Pfizer,,4.0,,,f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,INDUSTRY,,,,,,,2021,1.0
NCT02790996,,2016-04-07,,,2020-09-07,2016-05-31,2016-06-06,ESTIMATED,,,,,,,2020-09-07,2020-09-09,ACTUAL,2017-02-27,ACTUAL,2017-02-27,2020-09,2020-09-30,2020-04-01,ACTUAL,2020-04-01,2020-04-01,ACTUAL,2020-04-01,,INTERVENTIONAL,NeoVanc,,Neonatal Vancomycin Trial,"Multi-centre, Randomised, Open Label, Phase IIb Study to Compare the Efficacy, Safety and Pharmacokinetics (PK) of an Optimised Dosing to a Standard Dosing Regimen of Vancomycin in Neonates and Infants Aged ≤ 90 Days With Late Onset Bacterial Sepsis Known or Suspected to be Caused by Gram-positive Microorganisms",TERMINATED,,PHASE2,242.0,ACTUAL,PENTA Foundation,,2.0,,Planned interim analysis yielded different event rate affecting sample size and ability to recruit sufficient numbers within remaining trial time frame,f,,,,t,f,f,,,,,,,,,,,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,NETWORK,,,,,,,2020,0.0
NCT01790503,,2013-02-07,2019-08-22,2018-11-13,2020-06-19,2013-02-11,2013-02-13,ESTIMATED,2019-09-18,2019-10-09,ACTUAL,2018-11-13,2018-11-16,ACTUAL,2020-06-19,2020-06-30,ACTUAL,2013-07-18,ACTUAL,2013-07-18,2020-06,2020-06-30,2020-03-04,ACTUAL,2020-03-04,2017-11-03,ACTUAL,2017-11-03,,INTERVENTIONAL,,,A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma,An Open Label Phase 1b/2 Study of Orally Administered PLX3397 in Combination With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma,COMPLETED,,PHASE1/PHASE2,65.0,ACTUAL,Daiichi Sankyo,,4.0,,,f,,,,t,,,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,INDUSTRY,,,,,,,2020,1.0
NCT02418572,,2015-04-13,,,2024-05-21,2015-04-15,2015-04-16,ESTIMATED,,,,,,,2024-05-21,2024-05-22,ACTUAL,2015-04,,2015-04-30,2024-05,2024-05-31,2024-02,ACTUAL,2024-02-29,2023-12,ACTUAL,2023-12-31,,INTERVENTIONAL,T-TRANSPORT,,Testosterone TRANSdermal Gel for Poor Ovarian Responders Trial,Transdermal Testosterone Gel for Poor Ovarian Responders. A Multicenter Double-blind Placebo Controlled Randomized Trial,TERMINATED,,PHASE3,290.0,ACTUAL,Institut Universitari Dexeus,,2.0,,"Having reached the sample size described for the interim analysis and having seen the post-interim results, the sponsor has decided to stop the trial due to futility.",f,,,,t,,,,,,,,,,,,,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,OTHER,,,,,,,2024,0.0
NCT04437485,,2020-06-01,2023-08-24,,2023-10-10,2020-06-16,2020-06-18,ACTUAL,2023-10-10,2023-11-02,ACTUAL,,,,2023-10-10,2023-11-02,ACTUAL,2020-10-14,ACTUAL,2020-10-14,2023-10,2023-10-31,2022-08-29,ACTUAL,2022-08-29,2022-08-29,ACTUAL,2022-08-29,,INTERVENTIONAL,,,eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk,eIMPACT-DM Pilot Trial: Depression Treatment to Reduce the Excess Diabetes Risk of People With Depression and Prediabetes,COMPLETED,,PHASE2,46.0,ACTUAL,Indiana University,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,OTHER,,,,,,,2022,1.0
NCT04992247,,2021-07-28,,,2024-04-15,2021-08-03,2021-08-05,ACTUAL,,,,,,,2024-04-15,2024-04-17,ACTUAL,2024-02,ESTIMATED,2024-02-29,2024-04,2024-04-30,2024-09,ESTIMATED,2024-09-30,2024-07,ESTIMATED,2024-07-31,,INTERVENTIONAL,BR,,Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 Long Haul Pulmonary Compromise,"A Phase 2A Randomized, Placebo-Controlled Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 Long Haul Pulmonary Compromise",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,2.0,,Sorrento Therapeutics filed for chapter 11 bankruptcy.,f,,,,,t,f,,,,,,,,,,,2024-10-17 02:11:49.720005,2024-10-17 02:11:49.720005,INDUSTRY,,,,,,,2024,0.0
NCT03332173,,2017-11-02,2022-01-10,,2022-03-07,2017-11-02,2017-11-06,ACTUAL,2022-01-10,2022-03-08,ACTUAL,,,,2022-03-07,2022-03-09,ACTUAL,2017-08-31,ACTUAL,2017-08-31,2022-03,2022-03-31,2021-01-11,ACTUAL,2021-01-11,2019-05-08,ACTUAL,2019-05-08,,INTERVENTIONAL,,,Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM),"A Phase 2, Single-Arm, Open-Label, Multicenter Study of Bruton's Tyrosine Kinase (BTK) Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM)",COMPLETED,,PHASE2,44.0,ACTUAL,BeiGene,,1.0,,,f,,,,t,f,f,,,,,,,,,YES,,2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,INDUSTRY,,,,,,,2021,1.0
NCT02953145,,2015-09-18,,,2022-05-16,2016-10-31,2016-11-02,ESTIMATED,,,,,,,2022-05-16,2022-05-20,ACTUAL,2019-09-01,ESTIMATED,2019-09-01,2021-09,2021-09-30,2020-12-01,ESTIMATED,2020-12-01,2020-09-01,ESTIMATED,2020-09-01,,INTERVENTIONAL,,,The Use of Fibrin Sealant to Reduce Post Operative Pain in Cleft Palate Surgery,The Use of Fibrin Sealant to Reduce Post Operative Pain in Cleft Palate Surgery,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Alberta,,2.0,,Lack of support,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,OTHER,,,,,,,2020,0.0
NCT03776695,,2018-12-12,,,2022-03-08,2018-12-13,2018-12-17,ACTUAL,,,,,,,2022-03-08,2022-03-24,ACTUAL,2018-10-09,ACTUAL,2018-10-09,2022-03,2022-03-31,2022-01-05,ACTUAL,2022-01-05,2022-01-05,ACTUAL,2022-01-05,,INTERVENTIONAL,,,Safety and Tolerability of an Antibody Against Zika Virus (Tyzivumab) in ZIKV Infected Patients,"Phase 1 Time Lagged, Parallel-Group, Randomized, Placebo-Controlled, Single-Blind, Single Ascending Dose Study of Tyzivumab in ZIKV Infected Patients",WITHDRAWN,,PHASE1,0.0,ACTUAL,Tychan Pte Ltd.,,8.0,,Lack of Zika infected patients,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,INDUSTRY,,,,,,,2022,0.0
NCT04363372,,2020-04-24,,,2021-06-11,2020-04-24,2020-04-27,ACTUAL,,,,,,,2021-06-11,2021-06-16,ACTUAL,2020-08,ESTIMATED,2020-08-31,2020-06,2020-06-30,2021-01,ESTIMATED,2021-01-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19,"A Pilot, Multiple Dose Study to Evaluate the Efficacy and Safety of MRx-4DP0004 in Hospitalised Patients With Symptoms of COVID-19 (SARS-CoV-2 Infection)",WITHDRAWN,,PHASE2,0.0,ACTUAL,4D pharma plc,,2.0,,Recruitment Issues,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,INDUSTRY,,,,,,,2021,0.0
NCT04492436,,2020-07-22,,,2022-02-02,2020-07-27,2020-07-30,ACTUAL,,,,,,,2022-02-02,2022-02-18,ACTUAL,2021-10,ESTIMATED,2021-10-31,2021-08,2021-08-31,2024-07,ESTIMATED,2024-07-31,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,,,A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo,"A Randomized, Double-blind, Placebo-controlled, Multi-national, Multi-center, Parallel-group, Phase 2b Assessing ART-123's Effect on Preventing Sensory Symptoms of OIPN in Unresectable mCRC Subjects Receiving Oxaliplatin-containing Chemo",WITHDRAWN,,PHASE2,0.0,ACTUAL,Veloxis Pharmaceuticals,,3.0,,Study design was changed,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,INDUSTRY,,,,,,,2024,0.0
NCT04303000,,2020-03-03,2022-09-25,,2023-10-27,2020-03-06,2020-03-10,ACTUAL,2023-10-27,2023-10-30,ACTUAL,,,,2023-10-27,2023-10-30,ACTUAL,2021-07-11,ACTUAL,2021-07-11,2023-10,2023-10-31,2022-01-13,ACTUAL,2022-01-13,2022-01-13,ACTUAL,2022-01-13,,INTERVENTIONAL,,Baseline characteristics described here are for the 111 participants enrolled in the training portion of the study who were randomized to either the Opioid Overdose Education and Naloxone Distribution or Opioid Overdose Education groups.,Increasing Naloxone Access for Persons Who Use Opioids,Increasing Naloxone Access for Persons Who Use Opioids: An Online Recruitment and Training Approach to Opioid Overdose Education and Naloxone Distribution,COMPLETED,,PHASE4,111.0,ACTUAL,University of Alabama at Birmingham,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,OTHER,,,,,,,2022,1.0
NCT02354703,,2015-01-23,2021-11-09,,2021-12-16,2015-01-29,2015-02-03,ESTIMATED,2021-12-16,2022-01-14,ACTUAL,,,,2021-12-16,2022-01-14,ACTUAL,2015-08,ACTUAL,2015-08-31,2021-12,2021-12-31,2020-03-31,ACTUAL,2020-03-31,2020-03-31,ACTUAL,2020-03-31,,INTERVENTIONAL,,,Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder",COMPLETED,,PHASE2,293.0,ACTUAL,"University of Maryland, Baltimore",The pre-specified enrollment target of 256 participants starting treatment was calculated to detect a difference in change in drinks per drinking day between ondansetron and placebo groups at an effect size of 0.59 with a power of 0.84. The achieved enrollment of 95 participants was substantially below this pre-specified target.,4.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 05:17:09.601522,2024-10-16 05:17:09.601522,OTHER,,,,,,,2020,1.0
NCT04123483,,2019-10-09,,,2019-12-30,2019-10-09,2019-10-11,ACTUAL,,,,,,,2019-12-30,2020-01-02,ACTUAL,2019-11,ESTIMATED,2019-11-30,2019-12,2019-12-31,2022-11,ESTIMATED,2022-11-30,2021-11,ESTIMATED,2021-11-30,,INTERVENTIONAL,,,EnBrace HR for PMS With Prominent Mood Symptoms or Menstrual Related Mood Disorders,"EnBrace HR for Premenstrual Syndrome (PMS) With Prominent Mood Symptoms (or Menstrual Related Mood Disorders, MRMD)",WITHDRAWN,,PHASE4,0.0,ACTUAL,Massachusetts General Hospital,,1.0,,Cancellation of funding contract,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,OTHER,,,,,,,2022,0.0
NCT03005379,,2016-12-14,2023-08-23,,2024-03-14,2016-12-23,2016-12-29,ESTIMATED,2023-09-18,2023-10-11,ACTUAL,,,,2024-03-14,2024-04-11,ACTUAL,2018-11-15,ACTUAL,2018-11-15,2024-03,2024-03-31,2023-01-31,ACTUAL,2023-01-31,2022-08-30,ACTUAL,2022-08-30,,INTERVENTIONAL,MATCH,all participants who were randomized,Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH),CSP #2004 - Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH),TERMINATED,,PHASE2/PHASE3,153.0,ACTUAL,VA Office of Research and Development,,2.0,,Study is terminated for futility per protocol-specified interim analysis and DMC recommendation.,f,,,,f,t,f,,,f,,,,,,YES,"Digital data underlying primary scientific publications from this study will be held as part of a data sharing resource maintained by the Cooperative Studies Program (CSP). Study data held for this purpose may include data, data content, format, and organization. The data may be available to the public and other VA and non-VA researchers under certain conditions and consistent with the informed consent and CSP policy which prioritize protecting subjects' privacy and confidentiality to the fullest extent possible.",2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,FED,,,,,,,2023,0.0
NCT02698293,,2016-03-01,,,2022-11-21,2016-03-01,2016-03-03,ESTIMATED,,,,,,,2022-11-21,2022-11-22,ACTUAL,2019-12-01,ACTUAL,2019-12-01,2022-11,2022-11-30,2023-01-01,ESTIMATED,2023-01-01,2023-01-01,ESTIMATED,2023-01-01,,INTERVENTIONAL,,,PDT Plus Vitamin D3 for Anal Dysplasia,A Phase I Study of Photodynamic Therapy (PDT) Plus Vitamin D3 for High-grade Anal Dysplasia and Microinvasive Anal Cancer,WITHDRAWN,,PHASE1,0.0,ACTUAL,Abramson Cancer Center at Penn Medicine,,3.0,,Covid-19,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,OTHER,,,,,,,2023,0.0
NCT02362451,,2015-02-12,2022-01-27,,2022-03-10,2015-02-12,2015-02-13,ESTIMATED,2022-02-14,2022-03-08,ACTUAL,,,,2022-03-10,2022-03-18,ACTUAL,2015-07-10,ACTUAL,2015-07-10,2022-03,2022-03-31,2020-02-13,ACTUAL,2020-02-13,2020-02-13,ACTUAL,2020-02-13,,INTERVENTIONAL,,,Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate Cancer,"A Randomized, Placebo-Controlled Phase II Study of Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate Cancer",TERMINATED,,PHASE2,7.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,Slow accrual.,f,,,,t,t,f,,,,,,Clinical data available during the study and indefinitely.,Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).,,YES,All IPD recorded in the medical record will be shared with intramural investigators upon request. All collected individual participant data (IPD) will be shared with collaborators under the terms of collaborative agreements.,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,NIH,,,,,,,2020,0.0
NCT03261193,,2017-07-27,2023-08-17,,2024-05-03,2017-08-22,2017-08-24,ACTUAL,2024-05-03,2024-05-06,ACTUAL,,,,2024-05-03,2024-05-06,ACTUAL,2017-09-05,ACTUAL,2017-09-05,2024-05,2024-05-31,2022-11-11,ACTUAL,2022-11-11,2018-06-25,ACTUAL,2018-06-25,,INTERVENTIONAL,qlcsection,,ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain,QL Block for Post-cesarean Delivery Pain,TERMINATED,,PHASE3,21.0,ACTUAL,University of Pittsburgh,,2.0,,limited resources for recruitment,f,,,,f,t,f,,,,,,,,,NO,No plans to share,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,OTHER,,,,,,,2022,0.0
NCT04457765,,2020-06-30,,,2021-02-10,2020-06-30,2020-07-07,ACTUAL,,,,,,,2021-02-10,2021-02-12,ACTUAL,2021-04,ESTIMATED,2021-04-30,2021-02,2021-02-28,2022-09,ESTIMATED,2022-09-30,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,,,Betadine Effect on Nasal Mucosa Cilia,Povidine-Iodine Effect on Nasal Mucosa Cilia in Rhinoplasty Patients,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Boston Medical Center,,1.0,,The IRB did not approve the study to be conducted at the home institution.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,OTHER,,,,,,,2022,0.0
NCT05168904,,2021-12-09,,,2024-02-06,2021-12-09,2021-12-23,ACTUAL,,,,,,,2024-02-06,2024-02-08,ACTUAL,2021-10-22,ACTUAL,2021-10-22,2024-02,2024-02-29,2024-12,ESTIMATED,2024-12-31,2024-10,ESTIMATED,2024-10-31,,INTERVENTIONAL,,,"A Study to Investigate Fadraciclib (CYC065), in Subjects With Leukemia or Myelodysplastic Syndrome (MDS)","A Phase 1/2, Open Label, Multicenter Study to Investigate the Safety and Efficacy of Fadraciclib (CYC065), an Oral CDK 2/9 Inhibitor, in Subjects With Leukemias or Myelodysplastic Syndrome (MDS)",SUSPENDED,,PHASE1/PHASE2,210.0,ESTIMATED,"Cyclacel Pharmaceuticals, Inc.",,2.0,,Slow enrollment and financial limitations,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,INDUSTRY,,,,,,,2024,0.0
NCT04276207,,2020-02-18,2021-07-30,,2021-07-30,2020-02-18,2020-02-19,ACTUAL,2021-07-30,2021-08-25,ACTUAL,,,,2021-07-30,2021-08-25,ACTUAL,2020-02-25,ACTUAL,2020-02-25,2021-07,2021-07-31,2020-08-10,ACTUAL,2020-08-10,2020-08-10,ACTUAL,2020-08-10,,INTERVENTIONAL,,All randomized participants.,A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps,Effects of LY900014 on Recovery From Hyperglycemia Compared to Humalog in Subjects With Type 1 Diabetes Mellitus (T1DM) on Continuous Subcutaneous Insulin Infusion,COMPLETED,,PHASE1,32.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,INDUSTRY,,,,,,,2020,1.0
NCT03951077,,2019-05-06,2022-05-16,2021-12-27,2022-05-16,2019-05-14,2019-05-15,ACTUAL,2022-05-16,2022-06-08,ACTUAL,2021-12-27,2021-12-29,ACTUAL,2022-05-16,2022-06-08,ACTUAL,2019-08-12,ACTUAL,2019-08-12,2022-05,2022-05-31,2021-02-10,ACTUAL,2021-02-10,2021-02-10,ACTUAL,2021-02-10,,INTERVENTIONAL,,,Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome,"Phase 2, Multicenter, Double-blind (Sponsor-unblinded), Randomized, Placebo-Controlled Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome",COMPLETED,,PHASE2,118.0,ACTUAL,AbbVie,,6.0,,,f,,,,f,t,f,,,t,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,INDUSTRY,,,,,,,2021,1.0
NCT04663269,,2020-11-20,,,2021-04-21,2020-12-09,2020-12-10,ACTUAL,,,,,,,2021-04-21,2021-04-23,ACTUAL,2020-02-24,ACTUAL,2020-02-24,2021-04,2021-04-30,2020-09-24,ACTUAL,2020-09-24,2020-09-11,ACTUAL,2020-09-11,,INTERVENTIONAL,,,Regional Erector Spinae Analgesic Block vs Standard of Care Undergoing Percutaneous Nephrolithotomy,"Randomized, Prospective Trial of Regional Erector Spinae Analgesic Block Versus Standard of Care in Patients Undergoing Percutaneous Nephrolithotomy",TERMINATED,,PHASE4,5.0,ACTUAL,Indiana University,,2.0,,Drop out from surgeons from 3 to 1. It will take too long to feasibly accrue with only one provider.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,OTHER,,,,,,,2020,0.0
NCT02832037,,2016-07-07,2020-12-21,,2021-02-05,2016-07-11,2016-07-13,ESTIMATED,2021-02-05,2021-02-24,ACTUAL,,,,2021-02-05,2021-02-24,ACTUAL,2016-07-25,ACTUAL,2016-07-25,2021-02,2021-02-28,2020-01-29,ACTUAL,2020-01-29,2019-12-27,ACTUAL,2019-12-27,,INTERVENTIONAL,,The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.,Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia,"A Phase II Randomised, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of 4 Oral Doses of BI 425809 Once Daily Over 12 Week Treatment Period in Patients With Schizophrenia",COMPLETED,,PHASE2,509.0,ACTUAL,Boehringer Ingelheim,"After identifying a new major metabolite (BI 761036), the sponsor communicated a voluntary hold of Phase II to relevant competent authorities on 16-Sep-2016. This was formalized to a full clinical hold of the development program by the Food and Drug Administration (FDA) on 26-Oct-2016. Before start of the hold, 1 patient was screened, but not randomized. Clinical hold was removed by FDA on 21-Nov-2017, the trial was re-initiated with version 3 of the clinical trial protocol, dated 13-Dec-2017.",5.0,,,f,,,,,,,,,,,,,,,,,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,INDUSTRY,,,,,,,2020,1.0
NCT05788185,,2023-02-21,,,2023-10-13,2023-03-27,2023-03-28,ACTUAL,,,,,,,2023-10-13,2023-10-16,ACTUAL,2023-03-22,ACTUAL,2023-03-22,2023-10,2023-10-31,2023-09-21,ACTUAL,2023-09-21,2023-09-21,ACTUAL,2023-09-21,,INTERVENTIONAL,,,Safety & Immunogenicity of RVM-V001/RVM-V002 or RVMV001+RVMV002 (Co Administered as Separate Injections) in Healthy Individuals,"Phase 1b, Randomized, Open-label Study to Evaluate the Safety, Tolerability, and Immunogenicity of RVM-V001 Only, RVM-V002 Only, or RVM V001 + RVM V002 (Co Administered as Separate Injections) in Healthy Adults Previously Vaccinated With an Inactivated Virus or mRNA-based COVID-19 Vaccine in Singapore",TERMINATED,,PHASE1/PHASE2,24.0,ACTUAL,"RVAC Medicines (US), Inc.",,6.0,,Changes in COVID-19 pandemic landscape,f,,,,t,f,f,,,,,,,,,,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,OTHER,,,,,,,2023,0.0
NCT02600507,,2015-11-05,2023-04-24,,2023-04-24,2015-11-06,2015-11-09,ESTIMATED,2023-04-24,2023-05-17,ACTUAL,,,,2023-04-24,2023-05-17,ACTUAL,2016-03-07,ACTUAL,2016-03-07,2021-04,2021-04-30,2020-07-02,ACTUAL,2020-07-02,2020-07-02,ACTUAL,2020-07-02,,INTERVENTIONAL,,,Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression,"Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Adjunctive to Lithium or Valproate in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder",COMPLETED,,PHASE3,529.0,ACTUAL,"Intra-Cellular Therapies, Inc.",,3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,INDUSTRY,,,,,,,2020,1.0
NCT05579977,,2022-10-11,2024-07-09,,2024-07-09,2022-10-11,2022-10-14,ACTUAL,2024-07-09,2024-08-01,ACTUAL,,,,2024-07-09,2024-08-01,ACTUAL,2022-10-27,ACTUAL,2022-10-27,2024-07,2024-07-31,2023-09-22,ACTUAL,2023-09-22,2023-07-14,ACTUAL,2023-07-14,,INTERVENTIONAL,,Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.,Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity,"A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, DOSE RANGING, DOSE FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-07081532, AND OPEN LABEL ORAL SEMAGLUTIDE, IN ADULTS WITH TYPE 2 DIABETES MELLITUS (T2DM) INADEQUATELY CONTROLLED ON METFORMIN, AND SEPARATELY PF-07081532 COMPARED TO MATCHING PLACEBO IN ADULTS WITH OBESITY BUT WITHOUT T2DM",TERMINATED,,PHASE2,902.0,ACTUAL,Pfizer,1 participant in placebo (T2DM) arm with withdrawal reason as Death in treatment phase was also counted in follow-up with the reason for discontinuation as death since exact date of last dose was unknown.,13.0,,The decision to terminate clinical development of PF-07081532 is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 02:53:41.658738,2024-10-15 02:53:41.658738,INDUSTRY,,,,,,,2023,0.0
NCT04409873,,2020-05-28,2023-09-08,,2023-10-26,2020-05-28,2020-06-01,ACTUAL,2023-10-26,2023-11-18,ACTUAL,,,,2023-10-26,2023-11-18,ACTUAL,2021-03-31,ACTUAL,2021-03-31,2023-10,2023-10-31,2022-09-10,ACTUAL,2022-09-10,2022-09-10,ACTUAL,2022-09-10,,INTERVENTIONAL,AMPoL,,Antiseptic Mouthwash / Pre-Procedural Rinse on SARS-CoV-2 Load (COVID-19),Effect of Antiseptic Mouthwash/Gargling Solutions and Pre-procedural Rinse on SARS-CoV-2 Load (COVID-19),TERMINATED,,PHASE2,54.0,ACTUAL,"University of California, San Francisco","Study support was withdrawn by Funder, so enrollment ended, and only a priori planned interim analyses were performed.",5.0,,"The funder decided not to continue funding, causing enrollment to cease prematurely and curtailing originally planned analyses. Participants with any samples collected after the baseline pre-rinse samples were included in the analysis.",f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,OTHER,,,,,,,2022,0.0
NCT03875560,,2016-08-16,,,2019-03-12,2019-03-12,2019-03-14,ACTUAL,,,,,,,2019-03-12,2019-03-14,ACTUAL,2019-05,ESTIMATED,2019-05-31,2019-03,2019-03-31,2020-06,ESTIMATED,2020-06-30,2020-01,ESTIMATED,2020-01-31,,INTERVENTIONAL,,,IC14 in Adult Patients With Dengue Fever,"A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Safety, Pharmacokinetic, Pharmacodynamic and Preliminary Efficacy Study of IC14 in Adult Patients With Dengue Fever",WITHDRAWN,,PHASE2,0.0,ACTUAL,Implicit Bioscience,,5.0,,seeking funding,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,INDUSTRY,,,,,,,2020,0.0
NCT03977480,,2019-04-27,,,2024-02-29,2019-06-05,2019-06-06,ACTUAL,,,,,,,2024-02-29,2024-03-01,ACTUAL,2019-08-13,ACTUAL,2019-08-13,2024-02,2024-02-29,2022-08-12,ACTUAL,2022-08-12,2022-08-12,ACTUAL,2022-08-12,,INTERVENTIONAL,,,Phase II Study of Hemay007 in Patients With Active Ulcerative Colitis,"A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Clinical Study on the Effecacy and Safety of Different Dosing Regimens of Hemay007 in Patients With Active Ulcerative Colitis",TERMINATED,,PHASE2,70.0,ACTUAL,"Ganzhou Hemay Pharmaceutical Co., Ltd",,4.0,,"Due to the difficulty to recruit enough patients, the study was terminated.",f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,INDUSTRY,,,,,,,2022,0.0
NCT04051957,,2019-08-07,2022-06-30,2021-06-23,2022-08-02,2019-08-07,2019-08-09,ACTUAL,2022-08-02,2022-08-03,ACTUAL,2022-08-02,2022-08-03,ACTUAL,2022-08-02,2022-08-03,ACTUAL,2019-09-26,ACTUAL,2019-09-26,2022-08,2022-08-31,2021-02-12,ACTUAL,2021-02-12,2021-02-12,ACTUAL,2021-02-12,,INTERVENTIONAL,,,Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury,Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury,TERMINATED,,PHASE2,9.0,ACTUAL,"The University of Texas Health Science Center, Houston",Early termination due to the COVID pandemic and limited clinical face-to-face appointments leading to small numbers of subjects analyzed.,2.0,,Delays due to COVID and loss of research coordinator.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,OTHER,,,,,,,2021,0.0
NCT03472560,,2018-02-28,2024-01-29,,2024-03-12,2018-03-20,2018-03-21,ACTUAL,2024-03-12,2024-04-09,ACTUAL,,,,2024-03-12,2024-04-09,ACTUAL,2018-05-02,ACTUAL,2018-05-02,2024-03,2024-03-31,2023-02-09,ACTUAL,2023-02-09,2023-02-09,ACTUAL,2023-02-09,,INTERVENTIONAL,,Full Analysis Set included all participants who received at least one dose of avelumab and axitinib.,A Study of Avelumab in Combination With Axitinib In Non-Small Cell Lung Cancer (NSCLC) or Urothelial Cancer (Javelin Medley VEGF),"A PHASE 2, OPEN LABEL STUDY TO EVALUATE SAFETY AND CLINICAL ACTIVITY OF AVELUMAB (BAVENCIO (REGISTERED)) IN COMBINATION WITH AXITINIB (INLYTA (REGISTERED)) IN PATIENTS WITH ADVANCED OR METASTATIC PREVIOUSLY TREATED NON-SMALL CELL LUNG CANCER OR TREATMENT NAÏVE CISPLATIN-INELIGIBLE UROTHELIAL CANCER JAVELIN MEDLEY VEGF",TERMINATED,,PHASE2,61.0,ACTUAL,Pfizer,,1.0,,The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522),f,,,,f,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,INDUSTRY,,,,,,,2023,0.0
NCT05035680,,2021-08-31,,,2022-11-15,2021-09-01,2021-09-05,ACTUAL,,,,,,,2022-11-15,2022-11-17,ACTUAL,2022-07-14,ESTIMATED,2022-07-14,2022-11,2022-11-30,2023-11-25,ESTIMATED,2023-11-25,2023-03-25,ESTIMATED,2023-03-25,,INTERVENTIONAL,,,"Proof of Concept Trial of Adjuvant Activity of SWE, a Squalene-based -Oil-in-water Emulsion","Proof of Concept Trial of Adjuvant Activity of SWE, a Squalene-based -Oil-in-water Emulsion",WITHDRAWN,,PHASE1,0.0,ACTUAL,Bill & Melinda Gates Medical Research Institute,,3.0,,Study cancelled,f,,,,t,f,f,,,,,,,,,,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,OTHER,,,,,,,2023,0.0
NCT03078465,,2017-03-07,,,2021-08-18,2017-03-07,2017-03-13,ACTUAL,,,,,,,2021-08-18,2021-08-19,ACTUAL,2017-06-20,ACTUAL,2017-06-20,2021-08,2021-08-31,2021-05-30,ESTIMATED,2021-05-30,2021-05-30,ESTIMATED,2021-05-30,,INTERVENTIONAL,PL-PLATELET,,Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After PCI,Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After Percutaneous Coronary Intervention: The PL-PLATELET Randomized Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,"Nanjing First Hospital, Nanjing Medical University",,2.0,,"Competitive studies were conducted at the same time, and enrollment was suspended.",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,OTHER,,,,,,,2021,0.0
NCT03188445,,2017-06-13,,,2020-11-11,2017-06-14,2017-06-15,ACTUAL,,,,,,,2020-11-11,2020-11-13,ACTUAL,2017-07-11,ACTUAL,2017-07-11,2020-10,2020-10-31,2020-08-18,ACTUAL,2020-08-18,2020-06-26,ACTUAL,2020-06-26,,INTERVENTIONAL,,,Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy.,"Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy: a Randomised, Comparative, Open-label Trial",COMPLETED,,PHASE4,201.0,ACTUAL,Pharmacosmos A/S,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,INDUSTRY,,,,,,,2020,1.0
NCT05722301,,2019-08-16,,,2023-02-01,2023-02-01,2023-02-10,ACTUAL,,,,,,,2023-02-01,2023-02-10,ACTUAL,2019-11-01,ESTIMATED,2019-11-01,2023-02,2023-02-28,2021-11-01,ESTIMATED,2021-11-01,2020-11-01,ESTIMATED,2020-11-01,,INTERVENTIONAL,,,Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial,Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,American Hip Institute,,2.0,,Study was never initiated.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,OTHER,,,,,,,2021,0.0
NCT03896295,,2019-03-28,2021-12-07,,2023-06-07,2019-03-28,2019-03-29,ACTUAL,2022-01-25,2022-02-16,ACTUAL,,,,2023-06-07,2023-06-27,ACTUAL,2019-08-06,ACTUAL,2019-08-06,2023-05,2023-05-31,2020-12-09,ACTUAL,2020-12-09,2020-12-09,ACTUAL,2020-12-09,,INTERVENTIONAL,,,"An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis","An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis",TERMINATED,,PHASE2,37.0,ACTUAL,"Momenta Pharmaceuticals, Inc.","Study was originally halted due to the COVID-19 pandemic. The study was later terminated prematurely due to the continuing COVID-19 pandemic, and because the participants will have the option to enter into an open-label extension portion of a planned future study. It was not due to safety concerns.",1.0,,Study was originally halted due to the COVID-19 pandemic. The study was later terminated prematurely as the participants will have the option to enter into an open-label extension portion of a planned future study. It was not due to safety concerns.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,INDUSTRY,,,,,,,2020,0.0
NCT03809013,,2019-01-16,,,2023-11-24,2019-01-16,2019-01-18,ACTUAL,,,,,,,2023-11-24,2023-11-27,ACTUAL,2019-01-07,ACTUAL,2019-01-07,2023-11,2023-11-30,2023-06-05,ACTUAL,2023-06-05,2021-03-04,ACTUAL,2021-03-04,,INTERVENTIONAL,,,"A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer","A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer",COMPLETED,,PHASE2,64.0,ACTUAL,"RemeGen Co., Ltd.",,1.0,,,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-16 13:06:01.559683,2024-10-16 13:06:01.559683,INDUSTRY,,,,,,,2023,1.0
NCT02949128,,2016-10-25,2019-12-11,,2024-01-24,2016-10-27,2016-10-31,ESTIMATED,2020-02-07,2020-02-10,ACTUAL,,,,2024-01-24,2024-02-20,ACTUAL,2017-01-11,ACTUAL,2017-01-11,2024-01,2024-01-31,2023-01-24,ACTUAL,2023-01-24,2023-01-24,ACTUAL,2023-01-24,,INTERVENTIONAL,,"Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, and met pre-specified eligibility criteria.",Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS),Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-naïve Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS),COMPLETED,,PHASE3,58.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,INDUSTRY,,,,,,,2023,1.0
NCT02619760,,2015-11-29,,,2024-06-12,2015-11-29,2015-12-02,ESTIMATED,,,,,,,2024-06-12,2024-06-14,ACTUAL,2015-12,ACTUAL,2015-12-31,2024-06,2024-06-30,2023-12-31,ACTUAL,2023-12-31,2018-12-08,ACTUAL,2018-12-08,,INTERVENTIONAL,STOPDAPT-2,,ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study,ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study,COMPLETED,,PHASE4,3045.0,ACTUAL,"Kyoto University, Graduate School of Medicine",,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER,,,,,,,2023,1.0
NCT04870073,,2021-04-20,,,2023-02-27,2021-04-29,2021-05-03,ACTUAL,,,,,,,2023-02-27,2023-02-28,ACTUAL,2022-09-21,ACTUAL,2022-09-21,2023-02,2023-02-28,2022-09-21,ACTUAL,2022-09-21,2022-09-21,ACTUAL,2022-09-21,,INTERVENTIONAL,RAPPER-MAN,,Retrograde Autologous Priming and Mannitol for Reducing Hemodilution in Cardiac Surgery,Retrograde Autologous Priming for Preserving Hemoglobin Peri-operatively With or Without Mannitol: A Pilot Study,WITHDRAWN,,PHASE3,0.0,ACTUAL,Hamilton Health Sciences Corporation,,4.0,,Financial support could not be obtained for the study,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,OTHER,,,,,,,2022,0.0
NCT02525029,,2015-07-14,2023-04-10,,2023-12-12,2015-08-13,2015-08-17,ESTIMATED,2023-12-12,2023-12-14,ACTUAL,,,,2023-12-12,2023-12-14,ACTUAL,2016-03,ACTUAL,2016-03-31,2023-12,2023-12-31,2022-04,ACTUAL,2022-04-30,2021-05,ACTUAL,2021-05-31,,INTERVENTIONAL,,,Study of Pregnyl as Adjunct Therapy for High-Risk or Refractory Acute GVHD,Phase I/II Study of Human Chorionic Gonadotropin and Epidermal Growth Factor Supplementation (Pregnyl®) to Support Tolerance and Repair As Adjunct Therapy in High-Risk or Refractory Acute Graft-Versus-Host Disease,COMPLETED,,PHASE1/PHASE2,53.0,ACTUAL,"Masonic Cancer Center, University of Minnesota",,20.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 13:11:46.521972,2024-10-16 13:11:46.521972,OTHER,,,,,,,2022,1.0
NCT04516746,,2020-08-17,2022-03-03,,2024-02-02,2020-08-17,2020-08-18,ACTUAL,2022-03-31,2022-04-01,ACTUAL,,,,2024-02-02,2024-02-05,ACTUAL,2020-08-28,ACTUAL,2020-08-28,2024-02,2024-02-29,2023-02-10,ACTUAL,2023-02-10,2021-03-05,ACTUAL,2021-03-05,,INTERVENTIONAL,,All randomized participants analysis set included all participants who enrolled into the study.,"Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults","A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults, to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19",COMPLETED,,PHASE3,32450.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,INDUSTRY,,,,,,,2023,1.0
NCT05262101,,2022-03-01,,,2024-01-19,2022-03-01,2022-03-02,ACTUAL,,,,,,,2024-01-19,2024-01-22,ACTUAL,2022-05-09,ACTUAL,2022-05-09,2023-03,2023-03-31,2023-11-30,ACTUAL,2023-11-30,2023-06-28,ACTUAL,2023-06-28,,INTERVENTIONAL,,,Clinical Trial of TQB2858 Injection in the Treatment of Advanced High-grade Sarcoma,"Single-arm, Open-label, Multicenter Phase Ib Clinical Trial of TQB2858 Injection in the Treatment of Advanced High-grade Sarcoma",TERMINATED,,PHASE2,7.0,ACTUAL,"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",,1.0,,The sponsor has decided to terminate this study based on the current clinical research status of dual antibody drugs and full communication with the investigators.,f,,,,,f,f,,,,,,,,,,,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,INDUSTRY,,,,,,,2023,0.0
NCT02369653,,2015-01-21,2022-01-07,,2022-02-10,2015-02-18,2015-02-24,ESTIMATED,2022-02-10,2022-03-08,ACTUAL,,,,2022-02-10,2022-03-08,ACTUAL,2015-10-22,ACTUAL,2015-10-22,2022-02,2022-02-28,2021-07-07,ACTUAL,2021-07-07,2021-07-07,ACTUAL,2021-07-07,,INTERVENTIONAL,,,A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase,"A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Thromboembolism Prevention Versus No Systemic Anticoagulant Prophylaxis During Induction Chemotherapy in Children With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoma (T or B Cell) Treated With Asparaginase",COMPLETED,,PHASE3,512.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,INDUSTRY,,,,,,,2021,1.0
NCT05830747,,2023-03-27,,,2023-04-23,2023-04-23,2023-04-26,ACTUAL,,,,,,,2023-04-23,2023-04-26,ACTUAL,2022-02-01,ACTUAL,2022-02-01,2023-04,2023-04-30,2022-12-10,ACTUAL,2022-12-10,2022-10-25,ACTUAL,2022-10-25,,INTERVENTIONAL,,,Effect of Pre-emptive Dose of Prednisone Versus Placebo in Impacted Third Molar Surgery,Three-dimensional Facial Swelling Evaluation of Pre-operative Single-dose of Prednisone in Third Molar Surgery: a Split-mouth Randomized Controlled Trial,COMPLETED,,PHASE4,34.0,ACTUAL,University Magna Graecia,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,OTHER,,,,,,,2022,1.0
NCT03877237,,2019-02-21,2021-03-04,,2021-04-12,2019-03-14,2019-03-15,ACTUAL,2021-04-12,2021-05-05,ACTUAL,,,,2021-04-12,2021-05-05,ACTUAL,2019-04-09,ACTUAL,2019-04-09,2021-04,2021-04-30,2020-03-07,ACTUAL,2020-03-07,2020-03-07,ACTUAL,2020-03-07,,INTERVENTIONAL,,"Full Analysis Set: All participants that were randomized, regardless of whether treated or not.",DETERMINE-reduced - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Reduced Ejection Fraction,"International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients With Reduced Ejection Fraction",COMPLETED,,PHASE3,313.0,ACTUAL,AstraZeneca,"In this study, a subset of participants received wearable activity monitors to wear at home for 3 periods of 7 days. Data collection from the wearable device was challenging and a substantial amount of data was missing. This limits the use of the data based on the wearable activity monitors to investigate the potential impact of study drug on the amount, duration, and intensity of physical activity.",2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 13:11:46.521972,2024-10-16 13:11:46.521972,INDUSTRY,,,,,,,2020,1.0
NCT03852511,,2019-02-11,,,2022-06-23,2019-02-21,2019-02-25,ACTUAL,,,,,,,2022-06-23,2022-06-24,ACTUAL,2019-02-19,ACTUAL,2019-02-19,2022-06,2022-06-30,2022-02-04,ACTUAL,2022-02-04,2022-02-04,ACTUAL,2022-02-04,,INTERVENTIONAL,FORTITUDE,,First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody),"A Multicentre, Open Label, Non-randomised First in Human Study of NG-350A (Monotherapy), and NG-350A With a Check Point Inhibitor in Patients With Metastatic or Advanced Epithelial Tumours",COMPLETED,,PHASE1,28.0,ACTUAL,Akamis Bio,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,INDUSTRY,,,,,,,2022,1.0
NCT02922725,,2016-09-28,2022-03-08,,2022-05-26,2016-10-01,2016-10-04,ESTIMATED,2022-05-26,2022-05-31,ACTUAL,,,,2022-05-26,2022-05-31,ACTUAL,2016-11,ACTUAL,2016-11-30,2022-05,2022-05-31,2020-05,ACTUAL,2020-05-31,2020-05,ACTUAL,2020-05-31,,INTERVENTIONAL,,,Placebo-controlled Trial of 5-hydroxytryptophan and Creatine for SSRI or SNRI Augmentation in Treatment Resistant Depression in Females,"A Randomized, Double-blind, Placebo-controlled Trial of 5-hydroxytryptophan and Creatine for SSRI or SNRI Augmentation in Treatment Resistant Depression Associated With Hypobaric Hypoxia in Females",TERMINATED,,PHASE4,32.0,ACTUAL,University of Utah,Difficulties with recruitment suggest that the study may have been underpowered to detect an effect.,3.0,,COVID-19 pandemic,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER,,,,,,,2020,0.0
NCT04396535,,2020-05-14,,,2024-01-08,2020-05-18,2020-05-20,ACTUAL,,,,,,,2024-01-08,2024-01-10,ACTUAL,2020-10-23,ACTUAL,2020-10-23,2024-01,2024-01-31,2023-12-31,ACTUAL,2023-12-31,2023-12-31,ACTUAL,2023-12-31,,INTERVENTIONAL,,,Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer,Randomized Phase II Study of Standard Chemotherapy With Docetaxel With or Without Bintrafusp Alfa in Patients With Advanced NSCLC After Progressing on a Combination of Anti-PD-1/PD-L1 Agents and Chemotherapy,TERMINATED,,PHASE2,10.0,ACTUAL,Mayo Clinic,,2.0,,EMD Serono recommendation based on three other studies that failed to show benefit for bintrafusp alfa,,,,,t,t,f,,,,,,,,,,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER,,,,,,,2023,0.0
NCT03979313,,2019-05-30,2023-08-21,2022-02-03,2024-02-05,2019-06-06,2019-06-07,ACTUAL,2024-02-05,2024-02-28,ACTUAL,,2024-02-28,ACTUAL,2024-02-05,2024-02-28,ACTUAL,2019-07-23,ACTUAL,2019-07-23,2024-02,2024-02-29,2023-03-21,ACTUAL,2023-03-21,2021-03-11,ACTUAL,2021-03-11,,INTERVENTIONAL,MELODY,These are the Overall Number of All Subjects Population,A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY),"A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)",COMPLETED,,PHASE3,3012.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,INDUSTRY,,,,,,,2023,1.0
NCT04999839,,2021-07-19,2023-08-16,,2023-09-25,2021-08-02,2021-08-11,ACTUAL,2023-09-25,2023-09-28,ACTUAL,,,,2023-09-25,2023-09-28,ACTUAL,2021-08-11,ACTUAL,2021-08-11,2023-09,2023-09-30,2022-09-12,ACTUAL,2022-09-12,2022-08-19,ACTUAL,2022-08-19,,INTERVENTIONAL,,The modified intent-to-treat (mITT) analysis set included all participants who were randomized and received at least one dose of study treatment.,Study of NDI-034858 in Participants With Moderate to Severe Plaque Psoriasis,"A Phase 2b, Randomized, Multicenter, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Subjects With Moderate to Severe Plaque Psoriasis",COMPLETED,,PHASE2,259.0,ACTUAL,Takeda,,5.0,,,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,INDUSTRY,,,,,,,2022,1.0
NCT02888106,,2016-08-30,2020-12-29,,2021-04-07,2016-08-30,2016-09-02,ESTIMATED,2021-02-09,2021-02-25,ACTUAL,,,,2021-04-07,2021-04-30,ACTUAL,2016-04,ACTUAL,2016-04-30,2021-03,2021-03-31,2020-10-30,ACTUAL,2020-10-30,2019-11-22,ACTUAL,2019-11-22,,INTERVENTIONAL,,,Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent,"A Multicenter, Open-label, Randomised, Comparative, Parallel-Arm, Phase II Study to Assess Efficacy and Safety of Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent",COMPLETED,,PHASE2,90.0,ACTUAL,Hepatera Ltd.,,6.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,INDUSTRY,,,,,,,2020,1.0
NCT05430958,,2022-06-21,,,2022-11-12,2022-06-21,2022-06-24,ACTUAL,,,,,,,2022-11-12,2022-11-17,ACTUAL,2022-10,ESTIMATED,2022-10-31,2022-11,2022-11-30,2024-03,ESTIMATED,2024-03-31,2024-03,ESTIMATED,2024-03-31,,INTERVENTIONAL,,,"Safety, Tolerability and Immunogenicity of INO-4800 for COVID19 in Healthy Volunteers","Phase 1 Open Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Intradermal Booster Dose of INO-4800 Alone or in Combination With INO-9112 Followed by Electroporation, in Adults Who Completed a Primary Immunization Series Against SARS-CoV-2 With mRNA Vaccines",WITHDRAWN,,PHASE1,0.0,ACTUAL,Inovio Pharmaceuticals,,8.0,,Study was withdrawn due to sponsor decision.,f,,,,t,t,t,t,,,,,,,,NO,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,INDUSTRY,,,,,,,2024,0.0
NCT05000346,,2021-06-24,,,2023-01-05,2021-08-10,2021-08-11,ACTUAL,,,,,,,2023-01-05,2023-01-06,ACTUAL,2021-11-04,ACTUAL,2021-11-04,2023-01,2023-01-31,2022-12-21,ACTUAL,2022-12-21,2022-12-21,ACTUAL,2022-12-21,,INTERVENTIONAL,SIROCCO-1,,Clinical Trial to Assess the Efficacy and Safety of Inhaled AQ001S in the Management of Acute COVID-19 Symptoms,"A Randomized, Double-blind, Placebo-controlled, Parallel, Trial to Determine the Safety and Efficacy of Inhaled AQ001S in the Management of Acute COVID-19 Symptoms",TERMINATED,,PHASE2,21.0,ACTUAL,Aquilon Pharmaceuticals S.A.,,3.0,,Lack of patient to recruit,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,INDUSTRY,,,,,,,2022,0.0
NCT02610777,,2015-11-18,2020-08-31,,2022-08-24,2015-11-19,2015-11-20,ESTIMATED,2020-08-31,2020-09-23,ACTUAL,,,,2022-08-24,2022-09-19,ACTUAL,2016-04-14,ACTUAL,2016-04-14,2022-08,2022-08-31,2021-07-23,ACTUAL,2021-07-23,2019-09-04,ACTUAL,2019-09-04,,INTERVENTIONAL,,Intent-to-treat (IIT) population was defined as all participants who were randomized.,"An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)","A Phase 2, Randomized, Controlled, Open-Label, Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myelogenous Leukemia",COMPLETED,,PHASE2,120.0,ACTUAL,Takeda,,2.0,,,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,INDUSTRY,,,,,,,2021,1.0
NCT03129074,,2017-04-21,,,2018-05-21,2017-04-25,2017-04-26,ACTUAL,,,,,,,2018-05-21,2018-05-23,ACTUAL,2018-05,ESTIMATED,2018-05-31,2018-05,2018-05-31,2020-09,ESTIMATED,2020-09-30,2020-03,ESTIMATED,2020-03-31,,INTERVENTIONAL,,,Study of Varlitinib Plus Capecitabine in Patients With Advanced or Metastatic Biliary Tract Cancer,"A Phase 2, Single Arm Study of Varlitinib Plus Capecitabine in Patients With Advanced or Metastatic Biliary Tract Cancer as First-line Systemic Therapy",WITHDRAWN,,PHASE2,0.0,ACTUAL,ASLAN Pharmaceuticals,,1.0,,sponsor decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,OTHER,,,,,,,2020,0.0
NCT03760484,,2018-11-15,2022-09-14,,2022-11-16,2018-11-28,2018-11-30,ACTUAL,2022-11-16,2022-12-13,ACTUAL,,,,2022-11-16,2022-12-13,ACTUAL,2019-01-21,ACTUAL,2019-01-21,2022-10,2022-10-31,2020-03-10,ACTUAL,2020-03-10,2020-03-10,ACTUAL,2020-03-10,,INTERVENTIONAL,,,Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection,"Serial Fecal Microbiota Transplant (FMT) Plus Fidaxomicin in the Treatment of Severe or Fulminant Clostridium Difficile Infection, With Detailed Characterization in Microbiota, Metabolomics and Host Immune Response",TERMINATED,,PHASE2,4.0,ACTUAL,University of Alberta,,1.0,,Difficulty enrolling participants/COVID pandemic/lack of continued in-kind support from product manufacturer.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,OTHER,,,,,,,2020,0.0
NCT02921789,,2016-09-30,2021-12-07,,2022-06-10,2016-09-30,2016-10-03,ESTIMATED,2021-12-07,2022-01-05,ACTUAL,,,,2022-06-10,2022-06-14,ACTUAL,2017-05-22,ACTUAL,2017-05-22,2022-06,2022-06-30,2021-05-18,ACTUAL,2021-05-18,2020-12-11,ACTUAL,2020-12-11,,INTERVENTIONAL,,Safety (SAF) population: All participants who were randomized and received at least 1 dose of study drug.,Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients,"A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients",COMPLETED,,PHASE2,67.0,ACTUAL,Astellas Pharma Inc,,2.0,,,f,,,,t,t,f,,,,,,Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.,"Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.",https://www.clinicalstudydatarequest.com/,YES,"Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on ww.clinicalstudydatarequest.com.",2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,INDUSTRY,,,,,,,2021,1.0
NCT05694741,,2022-12-20,,,2023-09-22,2023-01-12,2023-01-23,ACTUAL,,,,,,,2023-09-22,2023-09-25,ACTUAL,2022-12-20,ACTUAL,2022-12-20,2023-09,2023-09-30,2023-05-10,ACTUAL,2023-05-10,2023-05-10,ACTUAL,2023-05-10,,INTERVENTIONAL,,,"A Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD0186","A Phase 1 Randomized, Single-blind, Placebo-controlled, First-in-Human and Sequential Group Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD0186 Following Single Ascending Doses Via Oral Administration",TERMINATED,,PHASE1,31.0,ACTUAL,AstraZeneca,,4.0,,The decision was based on the overall data profile obtained from this study which did not demonstrate sufficient differentiation to surpass the current standard of care.,,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual participant-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,INDUSTRY,,,,,,,2023,0.0
NCT03370159,,2017-12-04,,,2018-07-30,2017-12-11,2017-12-12,ACTUAL,,,,,,,2018-07-30,2018-08-01,ACTUAL,2018-06,ESTIMATED,2018-06-30,2018-07,2018-07-31,2020-03-01,ESTIMATED,2020-03-01,2019-03-01,ESTIMATED,2019-03-01,,INTERVENTIONAL,,,CPI-613 and Docetaxel in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer,A Phase I/II Open-Label Dose Escalation Trial of CPI-613 in Combination With Docetaxel Chemotherapy as a Second-Line Treatment of Non-Small-Cell Lung Cancer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Wake Forest University Health Sciences,,1.0,,Sponsor decided not to move forward,,,,,f,t,f,,,f,,,,,,,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,OTHER,,,,,,,2020,0.0
NCT03106571,,2017-03-07,,,2020-08-28,2017-04-04,2017-04-10,ACTUAL,,,,,,,2020-08-28,2020-09-01,ACTUAL,2017-08-01,ACTUAL,2017-08-01,2020-08,2020-08-31,2020-07-31,ACTUAL,2020-07-31,2020-07-31,ACTUAL,2020-07-31,,INTERVENTIONAL,POMA-MA-Ph1,,Study of Pomaglumetad and Methamphetamine,Phase 1 Safety-interaction Study of Pomaglumetad Methionil for Methamphetamine Use Disorder,TERMINATED,,PHASE1,19.0,ACTUAL,"University of California, Los Angeles",,4.0,,Deemed unable to enroll targeted participants in part due to COVID-19 shut downs,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER,,,,,,,2020,0.0
NCT03063632,,2017-02-22,2022-06-10,,2023-10-03,2017-02-22,2017-02-24,ACTUAL,2022-08-02,2022-08-30,ACTUAL,,,,2023-10-03,2023-10-25,ACTUAL,2017-12-14,ACTUAL,2017-12-14,2023-10,2023-10-31,2023-03-14,ACTUAL,2023-03-14,2021-04-08,ACTUAL,2021-04-08,,INTERVENTIONAL,,Patients do not have to complete the study in order to be included in the analysis population for the primary outcome measure.,Testing the Combination of Two Experimental Drugs MK-3475 (Pembrolizumab) and Interferon-gamma for the Treatment of Mycosis Fungoides and Sézary Syndrome and Advanced Synovial Sarcoma,A Phase II Trial of MK-3475 (Pembrolizumab) and Interferon Gamma 1-b Combination Immunotherapy in Patients With Previously Treated Mycosis Fungoides and Sezary Syndrome (Treatment Group 1) and in Patients With Advanced Synovial Sarcoma (Treatment Group 2),COMPLETED,,PHASE2,28.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 13:11:46.521972,2024-10-16 13:11:46.521972,NIH,,,,,,,2023,0.0
NCT03685773,,2018-09-24,,,2023-06-02,2018-09-24,2018-09-26,ACTUAL,,,,,,,2023-06-02,2023-06-05,ACTUAL,2019-04-21,ACTUAL,2019-04-21,2023-06,2023-06-30,2023-04-21,ACTUAL,2023-04-21,2023-04-21,ACTUAL,2023-04-21,,INTERVENTIONAL,,,The Role of Hepatic Denervation in the Dysregulation of Glucose Metabolism in Liver Transplant Recipients,The Role of Hepatic Denervation in the Dysregulation of Glucose Metabolism in Liver Transplant Recipients,WITHDRAWN,,PHASE2,0.0,ACTUAL,Albert Einstein College of Medicine,,12.0,,Permanently terminated due to COVID-19 given the poor vaccine penetrance in liver transplant recipients.~This is not a suspension of IRB approval.,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,OTHER,,,,,,,2023,0.0
NCT04319224,,2020-03-20,2023-05-02,,2024-05-28,2020-03-20,2020-03-24,ACTUAL,2024-05-28,2024-05-30,ACTUAL,,,,2024-05-28,2024-05-30,ACTUAL,2020-03-10,ACTUAL,2020-03-10,2024-05,2024-05-31,2023-01-03,ACTUAL,2023-01-03,2023-01-03,ACTUAL,2023-01-03,,INTERVENTIONAL,,,Vopratelimab (JTX-2011) Alone and in Combination With Anti-Programmed Cell Death Protein 1 (PD-1) or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) in Subjects With Advanced and/or Refractory Solid Tumors,"An Open-label, Multi-center, Rollover Study in Subjects With Advanced Solid Tumor Malignancies After Participation in a Vopratelimab (JTX-2011) Clinical Study",TERMINATED,,PHASE1/PHASE2,4.0,ACTUAL,"Jounce Therapeutics, Inc.",,3.0,,Sponsor decision to discontinue providing study drug to patients who have been on study treatment for more than two years,f,,,,,t,f,,,,,,,,,NO,,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,INDUSTRY,,,,,,,2023,0.0
NCT03547778,,2018-05-22,,,2021-06-14,2018-06-04,2018-06-06,ACTUAL,,,,,,,2021-06-14,2021-06-18,ACTUAL,2018-09-01,ACTUAL,2018-09-01,2019-03,2019-03-31,2020-03-25,ACTUAL,2020-03-25,2019-12-31,ACTUAL,2019-12-31,,INTERVENTIONAL,,,Misoprostol in Office Hysteroscopy and Endometrial Biopsy,Efficacy of Vaginal Misoprostol For Pain Relief During Office Hysteroscopy and Endometrial Biopsy; A Double Blind Randomized Controlled Trial,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of South Florida,,2.0,,Unable to get patients interested in the study,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER,,,,,,,2020,0.0
NCT04457960,,2020-07-01,,,2021-12-29,2020-07-01,2020-07-07,ACTUAL,,,,,,,2021-12-29,2022-01-12,ACTUAL,2020-07-01,ACTUAL,2020-07-01,2021-12,2021-12-31,2021-10-13,ACTUAL,2021-10-13,2021-10-13,ACTUAL,2021-10-13,,INTERVENTIONAL,,,A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative Colitis,"A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study in Healthy Participants and Multiple Dose Study in Participants With Ulcerative Colitis to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-66525433",TERMINATED,,PHASE1,82.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,Sponsor Decision.,f,,,,t,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,INDUSTRY,,,,,,,2021,0.0
NCT03707457,,2018-10-10,,,2020-06-30,2018-10-12,2018-10-16,ACTUAL,,,,,,,2020-06-30,2020-07-02,ACTUAL,2019-03-22,ACTUAL,2019-03-22,2020-06,2020-06-30,2020-06-18,ACTUAL,2020-06-18,2019-11-30,ACTUAL,2019-11-30,,INTERVENTIONAL,,,Biomarker-Driven Therapy Using Immune Activators With Nivolumab in Patients With First Recurrence of Glioblastoma,Phase I Protocol to Assess Safety of Biomarker-Driven Therapy Using Selective Immune Activators in Combination With Anti-PD-1 (Nivolumab) in Patients With First Recurrence of Glioblastoma,TERMINATED,,PHASE1,3.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,3.0,,Funding/material support withdrawn,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,OTHER,,,,,,,2020,0.0
NCT04176185,,2019-10-25,,,2022-06-27,2019-11-22,2019-11-25,ACTUAL,,,,,,,2022-06-27,2022-06-30,ACTUAL,2019-11-04,ACTUAL,2019-11-04,2021-02,2021-02-28,2022-01-19,ACTUAL,2022-01-19,2019-12-17,ACTUAL,2019-12-17,,INTERVENTIONAL,QUEST,,"A Research Study in Chinese People With Allergy to House Dust Mites, Using an Environmental Exposure Chamber",A Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) Sublingual Immunotherapy (SLIT)-Tablet in Adult Chinese Subjects With HDM Allergic Rhinitis/Rhinoconjunctivitis Using an Environmental Exposure Chamber,TERMINATED,,PHASE3,80.0,ACTUAL,ALK-Abelló A/S,,2.0,,COVID-19,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,INDUSTRY,,,,,,,2022,0.0
NCT03871855,,2019-02-17,,,2023-06-02,2019-03-10,2019-03-12,ACTUAL,,,,,,,2023-06-02,2023-06-05,ACTUAL,2019-04-28,ACTUAL,2019-04-28,2023-06,2023-06-30,2021-06-21,ACTUAL,2021-06-21,2021-06-21,ACTUAL,2021-06-21,,INTERVENTIONAL,,,A Study of SHR-1702 Alone or With Camrelizumab in Participants With Advanced Relapsed/Refractory Solid Tumors,A Study of SHR-1702 Alone or With Camrelizumab in Participants With Advanced Relapsed/Refractory Solid Tumors,TERMINATED,,PHASE1,8.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,4.0,,Sponsor R \& D Strategy Adjustment,f,,,,,f,f,,,,,,,,,,,2024-10-16 05:22:49.142697,2024-10-16 05:22:49.142697,INDUSTRY,,,,,,,2021,0.0
NCT04349176,,2020-04-14,,,2024-02-01,2020-04-14,2020-04-16,ACTUAL,,,,,,,2024-02-01,2024-02-05,ACTUAL,2017-05-12,ACTUAL,2017-05-12,2024-02,2024-02-29,2022-12-31,ACTUAL,2022-12-31,2019-12-31,ACTUAL,2019-12-31,,INTERVENTIONAL,,,Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?,OnabotulinumtoxinA for Chronic Headaches: Is 155 Units Superior to 100 Units?,TERMINATED,,PHASE3,35.0,ACTUAL,"United States Naval Medical Center, San Diego",,4.0,,Insufficient Recruitment,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 13:11:46.521972,2024-10-16 13:11:46.521972,FED,,,,,,,2022,0.0
NCT05221385,,2021-12-27,,,2023-11-03,2022-01-21,2022-02-03,ACTUAL,,,,,,,2023-11-03,2023-11-07,ACTUAL,2021-04-12,ACTUAL,2021-04-12,2023-10,2023-10-31,2023-10-27,ACTUAL,2023-10-27,2023-05-30,ACTUAL,2023-05-30,,INTERVENTIONAL,,,Gentulizumab in Patients With Advanced Solid Malignancies and Non-Hodgkin Lymphoma,"A Phase Ia, Open-label, Dose Escalation Study of Safety, Tolerability, Pharmacokinetics of Gentulizumab, an Anti-CD47 Monoclonal Antibody, in Patients With Advanced Solid Malignancies and Non-Hodgkin Lymphoma (NHL)",TERMINATED,,PHASE1,58.0,ACTUAL,"Changchun GeneScience Pharmaceutical Co., Ltd.",,1.0,,Due to changes in the sponsor's research strategy,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 13:11:46.521972,2024-10-16 13:11:46.521972,INDUSTRY,,,,,,,2023,0.0
NCT03269344,,2017-06-05,2021-11-22,,2022-01-19,2017-08-30,2017-08-31,ACTUAL,2021-12-20,2022-01-20,ACTUAL,,,,2022-01-19,2022-01-26,ACTUAL,2017-06-05,ACTUAL,2017-06-05,2022-01,2022-01-31,2020-12-09,ACTUAL,2020-12-09,2020-12-09,ACTUAL,2020-12-09,,INTERVENTIONAL,,,Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer,"Randomized Phase III, Double-Blind, Placebo Controlled Study of Prophylactic Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Squamous Cell Carcinoma",COMPLETED,,PHASE3,65.0,ACTUAL,Henry Ford Health System,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 05:28:36.040182,2024-10-16 05:28:36.040182,OTHER,,,,,,,2020,1.0
NCT02836340,,2016-06-01,,,2021-02-16,2016-07-14,2016-07-19,ESTIMATED,,,,,,,2021-02-16,2021-02-18,ACTUAL,2016-05,ACTUAL,2016-05-31,2021-02,2021-02-28,2020-04,ACTUAL,2020-04-30,2019-12,ACTUAL,2019-12-31,,INTERVENTIONAL,TIBOHCA,,"TIBOHCA: Safety, Tolerability and Pharmacokinetics of 2-Iminobiotin (2-IB) After OHCA","TIBOHCA: A Single-centre, Phase II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of 2-Iminobiotin (2-IB) After Out of Hospital Cardiac Arrest",TERMINATED,,PHASE1/PHASE2,21.0,ACTUAL,Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA),,1.0,,Inclusion of patients slow,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 13:11:46.521972,2024-10-16 13:11:46.521972,OTHER,,,,,,,2020,0.0
NCT05149287,,2021-11-24,2023-07-01,,2023-08-11,2021-11-24,2021-12-08,ACTUAL,2023-08-11,2023-09-05,ACTUAL,,,,2023-08-11,2023-09-05,ACTUAL,2021-12-28,ACTUAL,2021-12-28,2023-08,2023-08-31,2022-04-29,ACTUAL,2022-04-29,2022-04-29,ACTUAL,2022-04-29,,INTERVENTIONAL,PROPER,,PROPER Trial of Pain and Inflammation After Knee Arthroscopy,Early Reduction of Post-opeRative Pain and Inflammation to Expedite Return to Function After KNEE Arthroscopy,TERMINATED,,PHASE2,5.0,ACTUAL,University of Kentucky,,2.0,,Funding stopped,f,,,,,t,f,,,t,,,"Access to individual participant data will be available 1 year after the final study follow-up has been completed, and will be available until 5 years after the final study follow-up has been completed.",The researchers requesting access to participant information or samples must complete a questionnaire describing why they need information or samples for their research and how they will use the information or samples. The researchers who receive the information or samples will sign an agreement to use the data responsibly.,,YES,"With the participant's approval and as approved by local Institutional Review Boards (IRBs), de-identified biological samples will be stored at the University of Kentucky Orthopedic Biomarker Repository. These samples could be used to research the causes of osteoarthritis after cartilage or meniscus injury, its complications and other conditions for which individuals with cartilage or meniscus injuries are at increased risk, and to improve treatment.~Before sharing biomarker samples, we will ensure that the participant has given previous consent to the sharing of the information or samples. When we confirm that the previously provided consent is still in effect we will remove identifiers such as (e.g., name, medical record number, or date of birth). We will use a secure electronic log to track information shared without releasing the individual participant's identity.",2024-10-16 13:11:46.521972,2024-10-16 13:11:46.521972,OTHER,,,,,,,2022,0.0
NCT05312008,,2022-02-26,,,2024-05-23,2022-03-28,2022-04-05,ACTUAL,,,,,,,2024-05-23,2024-05-28,ACTUAL,2022-01-16,ACTUAL,2022-01-16,2024-05,2024-05-31,2023-12-21,ACTUAL,2023-12-21,2023-12-21,ACTUAL,2023-12-21,,INTERVENTIONAL,,,Does Oxytocin Alter Tolerance to or Motivation for Alcohol,Does Oxytocin Alter Tolerance to Alcohol or Motivation for Alcohol in Heavy Drinking Human Subjects: Testing a Novel Anti-Addiction Mechanism,TERMINATED,,PHASE2,6.0,ACTUAL,Indiana University,,2.0,,"Due to complications delaying the availability of the intranasal oxytocin and IV alcohol solutions needed for this project, we were unable to complete subjects in the self-administration arm of this study.",f,,,,t,t,f,,,,,,The dataset will be available indefinitely,On request to the PI,,YES,"The final raw dataset will be available to other researchers when we have collected all subjects, completed our own planned analyses, and, if warranted, sought and obtained funding based on the outcome of this pilot study.",2024-10-16 05:28:36.040182,2024-10-16 05:28:36.040182,OTHER,,,,,,,2023,0.0
NCT03619213,,2018-08-02,2023-03-09,,2023-07-10,2018-08-02,2018-08-07,ACTUAL,2023-07-10,2023-07-11,ACTUAL,,,,2023-07-10,2023-07-11,ACTUAL,2018-08-27,ACTUAL,2018-08-27,2023-07,2023-07-31,2022-03-27,ACTUAL,2022-03-27,2022-03-27,ACTUAL,2022-03-27,,INTERVENTIONAL,DELIVER,,Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.,"An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)",COMPLETED,,PHASE3,6263.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,t,t,f,,,f,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 05:28:36.040182,2024-10-16 05:28:36.040182,INDUSTRY,,,,,,,2022,1.0
NCT03520985,,2018-04-17,,,2021-06-07,2018-05-09,2018-05-11,ACTUAL,,,,,,,2021-06-07,2021-06-10,ACTUAL,2018-10-01,ACTUAL,2018-10-01,2021-06,2021-06-30,2021-02-03,ACTUAL,2021-02-03,2021-02-03,ACTUAL,2021-02-03,,INTERVENTIONAL,OptiPOM,,Alternate Day Dosing of Pomalidomide in Patients With Refractory Multiple Myeloma,"Alternate Day Dosing of Pomalidomide in Patients With Refractory Multiple Myeloma. A Multi-center, Single Arm Phase II Trial",TERMINATED,,PHASE2,34.0,ACTUAL,Swiss Group for Clinical Cancer Research,,1.0,,Feasibility (low patient accrual and financial reasons),f,,,,t,f,f,,,,,,,,,,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER,,,,,,,2021,0.0
NCT04481412,,2020-07-15,,,2023-02-07,2020-07-17,2020-07-22,ACTUAL,,,,,,,2023-02-07,2023-02-08,ACTUAL,2020-07-25,ACTUAL,2020-07-25,2023-02,2023-02-28,2021-11-30,ACTUAL,2021-11-30,2021-11-30,ACTUAL,2021-11-30,,INTERVENTIONAL,,,Topical Cetirizine in Androgenetic Alopecia in Females,The Role of Cetirizine in Androgenetic Alopecia in Females,COMPLETED,,PHASE2/PHASE3,66.0,ACTUAL,Cairo University,,2.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER,,,,,,,2021,1.0
NCT02959359,,2016-10-30,,,2017-08-04,2016-11-06,2016-11-09,ESTIMATED,,,,,,,2017-08-04,2017-08-07,ACTUAL,2016-11,,2016-11-30,2017-08,2017-08-31,2022-12,ESTIMATED,2022-12-31,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,DAA in the Risk of Recurrence After Curative Treatment of HCC,The Role of DAA in Reducing the Risk of Recurrence After Curative Treatment of HCC in Patients With Chronic Hepatitis C and Early Stage HCC,WITHDRAWN,,PHASE4,0.0,ACTUAL,"Taipei Veterans General Hospital, Taiwan",,1.0,,The supplies of study drug were halted by Gilead Sciences Ltd.,f,,,,f,,,,,,,,,,,UNDECIDED,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER_GOV,,,,,,,2022,0.0
NCT04585724,,2020-10-07,,,2021-10-13,2020-10-07,2020-10-14,ACTUAL,,,,,,,2021-10-13,2021-10-18,ACTUAL,2020-06-12,ACTUAL,2020-06-12,2021-10,2021-10-31,2021-09-13,ACTUAL,2021-09-13,2021-09-13,ACTUAL,2021-09-13,,INTERVENTIONAL,,,"Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases",Evaluation of Radiosurgery With Concurrent Cyclin-Dependent Kinase 4/6 Inhibitors in the Treatment of Brain Metastases,WITHDRAWN,,PHASE1,0.0,ACTUAL,Emory University,,3.0,,Closed due to low (0) accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER,,,,,,,2021,0.0
NCT03430791,,2018-01-31,2022-09-12,,2023-01-06,2018-02-06,2018-02-13,ACTUAL,2023-01-06,2023-02-02,ACTUAL,,,,2023-01-06,2023-02-02,ACTUAL,2018-12-05,ACTUAL,2018-12-05,2022-11,2022-11-30,2021-01-27,ACTUAL,2021-01-27,2020-05-29,ACTUAL,2020-05-29,,INTERVENTIONAL,,"No participants with prior PD1/PDL1 checkpoint inhibitor were enrolled, thus no participants were assigned to the Nivolumab+Ipilimumab arm.","Trial of Combination Tumor Treating Fields (TTF; Optune), Nivolumab Plus/Minus Ipilimumab for Recurrent Glioblastoma","A Phase I/II Trial of Combination Tumor Treating Fields, Nivolumab Plus/Minus Ipilimumab for Recurrent Glioblastoma",TERMINATED,,PHASE2,5.0,ACTUAL,Baptist Health South Florida,Did not accrue the target number of participants needed to achieve target power and statistically reliable results.,2.0,,Study Investigator/Sponsor decided to end enrollment earlier.,,,,,t,t,t,,,f,,,,,,NO,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER,,,,,,,2021,0.0
NCT03925155,,2019-04-16,,,2020-07-01,2019-04-22,2019-04-24,ACTUAL,,,,,,,2020-07-01,2020-07-07,ACTUAL,2020-05-01,ESTIMATED,2020-05-01,2020-07,2020-07-31,2023-05-01,ESTIMATED,2023-05-01,2022-05-01,ESTIMATED,2022-05-01,,INTERVENTIONAL,VAP,,RCT Investigating Pre-cesarean Vaginal Wash of Chlorhexidine vs Povidone-iodine for Patient With Ruptured Amniotic Membrane.,A Randomized Trial to Investigate if a Pre-operative Wash With Chlorhexidine vs Povidone-iodine Vaginal Scrub Decreases Infectious Morbidity in Patients Undergoing Cesarean Section After Ruptured Membranes,WITHDRAWN,,PHASE3,0.0,ACTUAL,Montefiore Medical Center,,2.0,,The study was withdrawn from the IRB,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,OTHER,,,,,,,2023,0.0
NCT04698525,,2020-12-08,2022-11-02,,2024-05-07,2021-01-04,2021-01-07,ACTUAL,2023-05-13,2023-05-17,ACTUAL,,,,2024-05-07,2024-05-09,ACTUAL,2019-02-15,ACTUAL,2019-02-15,2024-05,2024-05-31,2020-01-15,ACTUAL,2020-01-15,2020-01-15,ACTUAL,2020-01-15,,INTERVENTIONAL,,"A total of 33 subjects participated in the trial, 6 of which left due to covid-19 infections. In the end, 27 subjects completed the trial.",Comparative Study Between Valproate and Memantine in the Prophylactic Management of Episodic Migraine.,Efficacy of Memantine Compared With Sodium Valproate in the Prophylactic Treatment of Episodic Migraine.,COMPLETED,,PHASE3,33.0,ACTUAL,Universidad Autonoma de San Luis Potosí,,2.0,,,f,,,,,t,f,,,t,,,12 months,6 months,,YES,"This clinical trial is the thesis to obtain a specialist degree (Neurologist) of Dr. Damaris Daniela Vazquez-Guevara; at the end of the study, the plan is to publish as soon as possible.",2024-10-16 05:28:36.040182,2024-10-16 05:28:36.040182,OTHER,,,,,,,2020,1.0
NCT05352542,,2022-04-01,,,2024-08-08,2022-04-23,2022-04-29,ACTUAL,,,,,,,2024-08-08,2024-08-09,ACTUAL,2022-05-19,ACTUAL,2022-05-19,2024-08,2024-08-31,2024-07-31,ACTUAL,2024-07-31,2024-07-31,ACTUAL,2024-07-31,,INTERVENTIONAL,,,GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma,"A Phase I Clinical Trial for Evaluating the Safety, Tolerance and Efficacy of GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma",TERMINATED,,PHASE1,10.0,ACTUAL,The Affiliated Hospital of the Chinese Academy of Military Medical Sciences,,1.0,,achieve the proof of concept,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 05:28:36.040182,2024-10-16 05:28:36.040182,OTHER,,,,,,,2024,0.0
NCT04033367,,2019-07-16,2022-10-05,,2022-10-05,2019-07-24,2019-07-26,ACTUAL,2022-10-05,2022-11-02,ACTUAL,,,,2022-10-05,2022-11-02,ACTUAL,2019-08-22,ACTUAL,2019-08-22,2022-10,2022-10-31,2021-10-06,ACTUAL,2021-10-06,2021-10-06,ACTUAL,2021-10-06,,INTERVENTIONAL,,"Analysis was performed on intent-to-treat (ITT) analysis set which included all randomized participants with a treatment kit number allocated and recorded in the interactive response technology (IRT) database, regardless of whether the treatment kit was used or not and were analyzed according to the treatment group allocated by randomization.",SAR231893-LPS15497- Dupilumab Effect on Sleep in AD Patients,"A Randomized Double-blind, Placebo-controlled Study Evaluating the Effect of Dupilumab on Sleep in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)",COMPLETED,,PHASE4,188.0,ACTUAL,Sanofi,,2.0,,,f,,,,f,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,INDUSTRY,,,,,,,2021,1.0
NCT05013229,,2021-08-13,,,2024-02-21,2021-08-13,2021-08-19,ACTUAL,,,,,,,2024-02-21,2024-02-23,ACTUAL,2021-11-30,ACTUAL,2021-11-30,2024-02,2024-02-29,2023-11-14,ACTUAL,2023-11-14,2023-11-14,ACTUAL,2023-11-14,,INTERVENTIONAL,,,"A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3)","A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3",COMPLETED,,PHASE3,679.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,INDUSTRY,,,,,,,2023,1.0
NCT03361956,,2017-11-29,2022-09-02,2020-09-02,2022-10-24,2017-11-29,2017-12-05,ACTUAL,2022-10-24,2022-11-17,ACTUAL,2022-10-24,2022-11-17,ACTUAL,2022-10-24,2022-11-17,ACTUAL,2018-02-13,ACTUAL,2018-02-13,2022-10,2022-10-31,2020-08-13,ACTUAL,2020-08-13,2019-09-05,ACTUAL,2019-09-05,,INTERVENTIONAL,,,"An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection","A Phase 2a, Randomized, Partially-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Treatment With Multiple Doses of JNJ-56136379 as Monotherapy and in Combination With a Nucleos(t)Ide Analog in Subjects With Chronic Hepatitis B Virus Infection",COMPLETED,,PHASE2,232.0,ACTUAL,Janssen Sciences Ireland UC,,10.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 13:11:46.521972,2024-10-16 13:11:46.521972,INDUSTRY,,,,,,,2020,1.0
NCT05563610,,2022-09-27,,,2024-06-12,2022-09-29,2022-10-03,ACTUAL,,,,,,,2024-06-12,2024-06-14,ACTUAL,2022-09-26,ACTUAL,2022-09-26,2024-06,2024-06-30,2024-06-12,ACTUAL,2024-06-12,2024-06-12,ACTUAL,2024-06-12,,INTERVENTIONAL,,,Oral Penicillin Challenge and Allergy De-labeling in Children,Oral Penicillin Challenge and Allergy De-labeling in the Phoenix Children's Hospital Emergency Department,TERMINATED,,PHASE4,31.0,ACTUAL,Phoenix Children's Hospital,,2.0,,Unable to recruit sufficient number of subjects in the setting,f,,,,t,t,f,,,f,,,,,,NO,There is no plan to share IPD with other researchers at this time.,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER,,,,,,,2024,0.0
NCT05095961,,2021-09-29,,,2023-08-07,2021-10-25,2021-10-27,ACTUAL,,,,,,,2023-08-07,2023-08-09,ACTUAL,2023-03,ESTIMATED,2023-03-31,2023-08,2023-08-31,2024-08,ESTIMATED,2024-08-31,2024-03,ESTIMATED,2024-03-31,,INTERVENTIONAL,,,Pre-operative Steroids in CRSsP,Effect of Pre-operative Oral Steroids on Blood Loss in Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Polyps,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Loma Linda University,,2.0,,Technical difficulties encountered with recording intraoperative blood loss; unable to proceed with study.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER,,,,,,,2024,0.0
NCT02920892,,2016-09-28,2023-06-09,,2023-09-15,2016-09-28,2016-09-30,ESTIMATED,2023-09-15,2023-10-10,ACTUAL,,,,2023-09-15,2023-10-10,ACTUAL,2017-08-17,ACTUAL,2017-08-17,2023-09,2023-09-30,2022-05-17,ACTUAL,2022-05-17,2022-05-17,ACTUAL,2022-05-17,,INTERVENTIONAL,FX-LEARN,,AFQ056 for Language Learning in Children With FXS,Effects of AFQ056 on Language Learning in Young Children With Fragile X Syndrome (FXS),COMPLETED,,PHASE2,110.0,ACTUAL,Rush University Medical Center,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER,,,,,,,2022,1.0
NCT03085485,,2017-02-16,2023-10-27,,2023-12-19,2017-03-14,2017-03-21,ACTUAL,2023-12-19,2023-12-21,ACTUAL,,,,2023-12-19,2023-12-21,ACTUAL,2017-03-16,ACTUAL,2017-03-16,2023-12,2023-12-31,2022-09-30,ACTUAL,2022-09-30,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,,,The Topic Trial - Study to Determine the Safety and Efficacy of Ivacaftor,"A Randomized, Double-blind, Phase 2, Placebo Controlled Study to Determine the Safety and Efficacy of Ivacaftor (VX-770) for the Treatment of Chronic Obstructive Pulmonary Disease (The Topic Trial)",COMPLETED,,PHASE2,40.0,ACTUAL,University of Alabama at Birmingham,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:11:46.521972,2024-10-16 13:11:46.521972,OTHER,,,,,,,2022,0.0
NCT02850419,,2016-07-26,,,2022-03-29,2016-07-27,2016-08-01,ESTIMATED,,,,,,,2022-03-29,2022-04-07,ACTUAL,2017-03,ESTIMATED,2017-03-31,2022-03,2022-03-31,2020-02,ESTIMATED,2020-02-29,2019-12,ESTIMATED,2019-12-31,,INTERVENTIONAL,EURO-DIGNITY,,Heat-Activated Target Therapy of Local-Regional Relapse in Breast Cancer Patients,Heat-Activated Target Therapy (Radiotherapy + Hyperthermia + Lyso-Thermosensitive Liposomal Doxorubicin) of Local-Regional Relapse in Breast Cancer Patients,WITHDRAWN,,PHASE2,0.0,ACTUAL,Imunon,,1.0,,Administrative,f,,,,t,t,f,,,,,,,,,,,2024-10-16 05:28:36.040182,2024-10-16 05:28:36.040182,INDUSTRY,,,,,,,2020,0.0
NCT02524119,,2015-07-30,2021-01-08,,2021-01-28,2015-08-13,2015-08-14,ESTIMATED,2021-01-28,2021-02-01,ACTUAL,,,,2021-01-28,2021-02-01,ACTUAL,2016-04,ACTUAL,2016-04-30,2021-01,2021-01-31,2020-09,ACTUAL,2020-09-30,2020-09,ACTUAL,2020-09-30,,INTERVENTIONAL,LEE001,,LEE001 and Chemoembolization In Patients With Advanced Hepatocellular Carcinoma,A Phase Ib/II Study of LEE011 and Chemoembolization In Patients With Advanced Hepatocellular Carcinoma,TERMINATED,,PHASE2,5.0,ACTUAL,University of Texas Southwestern Medical Center,Data were not collected for some outcome due to early study termination.,1.0,,This study was terminated after the sponsor withdrew our support,f,,,,t,,,,,,,,,,,NO,,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,OTHER,,,,,,,2020,0.0
NCT01912625,,2013-07-29,,,2023-05-04,2013-07-29,2013-07-31,ESTIMATED,,,,,,,2023-05-04,2023-05-06,ACTUAL,2013-10-28,ACTUAL,2013-10-28,2023-05,2023-05-31,2023-02-24,ACTUAL,2023-02-24,2017-11-03,ACTUAL,2017-11-03,,INTERVENTIONAL,,,"Trametinib, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery",A Phase 1 Study of Trametinib in Combination With Chemoradiation for KRAS Mutant Non-small Cell Lung Cancer,TERMINATED,,PHASE1,16.0,ACTUAL,National Cancer Institute (NCI),,1.0,,Inadequate accrual rate,f,,,,f,,,,,,,,,,,,,2024-10-16 05:28:36.040182,2024-10-16 05:28:36.040182,NIH,,,,,,,2023,0.0
NCT05099640,,2021-10-06,2023-11-03,,2023-12-19,2021-10-18,2021-10-29,ACTUAL,2023-12-19,2024-01-10,ACTUAL,,,,2023-12-19,2024-01-10,ACTUAL,2021-09-30,ACTUAL,2021-09-30,2023-12,2023-12-31,2023-05-03,ACTUAL,2023-05-03,2023-04-03,ACTUAL,2023-04-03,,INTERVENTIONAL,,"Safety analysis set included all participants who received at least 1 dose of study drug, including during Part 1. Part 2 included participants (≥2 years of age) who experienced a ≥15% reduction in blood Phe levels (responder). Non-responders in Part 1 did not continue to Part 2.",A Study of PTC923 in Participants With Phenylketonuria,A Phase 3 Study of PTC923 in Subjects With Phenylketonuria,COMPLETED,,PHASE3,157.0,ACTUAL,PTC Therapeutics,,3.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 05:28:36.040182,2024-10-16 05:28:36.040182,INDUSTRY,,,,,,,2023,1.0
NCT03894345,,2019-02-14,,,2022-10-31,2019-03-26,2019-03-28,ACTUAL,,,,,,,2022-10-31,2022-11-02,ACTUAL,2019-05-24,ACTUAL,2019-05-24,2022-10,2022-10-31,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Prazosin Use in Adults With Anxiety Disorders,Open Label 8-Week Study of Prazosin Use in Adults With Anxiety Disorders,SUSPENDED,,PHASE1,20.0,ESTIMATED,University of Manitoba,,1.0,,COVID-19,f,,,,,f,f,,,f,,,,,,NO,,2024-10-16 05:28:36.040182,2024-10-16 05:28:36.040182,OTHER,,,,,,,2023,0.0
NCT03642145,,2018-07-10,,,2019-06-20,2018-08-20,2018-08-22,ACTUAL,,,,,,,2019-06-20,2019-06-21,ACTUAL,2018-10-31,ACTUAL,2018-10-31,2019-05,2019-05-31,2021-07-31,ESTIMATED,2021-07-31,2021-07-31,ESTIMATED,2021-07-31,,INTERVENTIONAL,PTCEMF,,A Study of Deflazacort (Emflaza®) in Participants With Duchenne Muscular Dystrophy (DMD),A 52-Week Phase 3B Randomized Open-Label Study Evaluating the Safety and Pharmacokinetics of Emflaza® (Deflazacort) Compared to a Comparable Natural History Control Group in Males Aged ≥2 to <5 Years With Duchenne Muscular Dystrophy (DMD) Followed by a 52-Week Extension Period,WITHDRAWN,,PHASE3,0.0,ACTUAL,PTC Therapeutics,,3.0,,Study is no longer necessary given the safety and efficacy of emflaza in this age range has already been established after review of already available data.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 05:28:36.040182,2024-10-16 05:28:36.040182,INDUSTRY,,,,,,,2021,0.0
NCT03342950,,2017-11-01,,,2021-10-13,2017-11-14,2017-11-17,ACTUAL,,,,,,,2021-10-13,2021-10-21,ACTUAL,2019-02-19,ACTUAL,2019-02-19,2021-10,2021-10-31,2021-10-12,ACTUAL,2021-10-12,2021-10-12,ACTUAL,2021-10-12,,INTERVENTIONAL,TTNP,,The Effects of Topical Treatment With Clonidine + Pentoxifylline in Patients With Neuropathic Pain,The Effects of Topical Treatment With Clonidine + Pentoxifylline in Patients With Neuropathic Pain,TERMINATED,,PHASE2,4.0,ACTUAL,McGill University Health Centre/Research Institute of the McGill University Health Centre,,2.0,,Low recruitment due to the COVID-19 pandemic,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 05:28:36.040182,2024-10-16 05:28:36.040182,OTHER,,,,,,,2021,0.0
NCT03742349,,2018-11-12,,,2024-01-17,2018-11-12,2018-11-15,ACTUAL,,,,,,,2024-01-17,2024-01-19,ACTUAL,2019-01-31,ACTUAL,2019-01-31,2024-01,2024-01-31,2023-02-06,ACTUAL,2023-02-06,2023-02-06,ACTUAL,2023-02-06,,INTERVENTIONAL,,,Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).,"A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Immunotherapy Combinations in Adult Patients With Triple-negative Breast Cancer",TERMINATED,,PHASE1,64.0,ACTUAL,Novartis,,4.0,,This was a sponsor decision and was not a consequence of any safety concern,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 05:28:36.040182,2024-10-16 05:28:36.040182,INDUSTRY,,,,,,,2023,0.0
NCT04325802,,2020-03-25,,,2023-03-31,2020-03-25,2020-03-30,ACTUAL,,,,,,,2023-03-31,2023-04-04,ACTUAL,2022-12-31,ESTIMATED,2022-12-31,2023-03,2023-03-31,2024-06,ESTIMATED,2024-06-30,2024-06,ESTIMATED,2024-06-30,,INTERVENTIONAL,,,Treatment of Chronic Itch in Atopic Dermatitis With Opioid Antagonist Naltrexone,Treatment of Chronic Itch in Atopic Dermatitis With Opioid Antagonist Naltrexone and Effects on Skin Circadian Rhythm,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Minnesota,,3.0,,Covid-19 pandemic,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER,,,,,,,2024,0.0
NCT05032950,,2021-08-27,2022-12-01,,2022-12-01,2021-08-27,2021-09-02,ACTUAL,2022-12-01,2023-10-04,ACTUAL,,,,2022-12-01,2023-10-04,ACTUAL,2021-09-17,ACTUAL,2021-09-17,2022-12,2022-12-31,2021-12-09,ACTUAL,2021-12-09,2021-12-09,ACTUAL,2021-12-09,,INTERVENTIONAL,,,Drug-Drug Interaction Study to Estimate the Effect of PF-07321332/Ritonavir and Ritonavir on Midazolam in Healthy Participants,"COVID-19: A PHASE 1, OPEN-LABEL, 3-TREATMENT, 6-SEQUENCE, 3-PERIOD CROSSOVER STUDY TO ESTIMATE THE EFFECT OF PF-07321332/RITONAVIR AND RITONAVIR ON THE PHARMACOKINETICS OF MIDAZOLAM IN HEALTHY PARTICIPANTS.",COMPLETED,,PHASE1,12.0,ACTUAL,Pfizer,,3.0,,,f,,,,,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 05:28:36.040182,2024-10-16 05:28:36.040182,INDUSTRY,,,,,,,2021,1.0
NCT02664155,,2016-01-22,,,2022-10-17,2016-01-22,2016-01-26,ESTIMATED,,,,,,,2022-10-17,2022-10-19,ACTUAL,2016-10-19,ACTUAL,2016-10-19,2022-10,2022-10-31,2022-05-30,ACTUAL,2022-05-30,2021-11-30,ACTUAL,2021-11-30,,INTERVENTIONAL,VERDICT,,Venous Thromboembolism in Renally Impaired Patients and Direct Oral Anticoagulants,Venous Thromboembolism in Renally Impaired Patients and Direct Oral Anticoagulants,TERMINATED,,PHASE3,203.0,ACTUAL,Centre Hospitalier Universitaire de Saint Etienne,,2.0,,recruiting difficulties,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 05:28:36.040182,2024-10-16 05:28:36.040182,OTHER,,,,,,,2022,0.0
NCT05103826,,2021-10-21,,,2023-08-13,2021-10-21,2021-11-02,ACTUAL,,,,,,,2023-08-13,2023-08-15,ACTUAL,2021-10-25,ACTUAL,2021-10-25,2023-08,2023-08-31,2023-06-15,ACTUAL,2023-06-15,2023-06-15,ACTUAL,2023-06-15,,INTERVENTIONAL,,,A Study of SHR6390 Combined With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer,A Phase I Study to Evaluate Safety 、Tolerability 、 Pharmacokinetics and Efficacy of SHR6390 in Combination With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer,TERMINATED,,PHASE1,3.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,1.0,,Sponsor R \& D Strategy Adjustment,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,INDUSTRY,,,,,,,2023,0.0
NCT02495922,,2015-06-24,,,2021-09-09,2015-07-10,2015-07-13,ESTIMATED,,,,,,,2021-09-09,2021-09-10,ACTUAL,2015-06,,2015-06-30,2021-09,2021-09-30,2021-06-24,ACTUAL,2021-06-24,2021-06-24,ACTUAL,2021-06-24,,INTERVENTIONAL,GMMG-HD6,,A Phase III Trial on the Effect of Elotuzumab in VRD Induction /Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma,A Randomized Phase III Trial on the Effect of Elotuzumab in VRD Induction /Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma,COMPLETED,,PHASE3,564.0,ACTUAL,University of Heidelberg Medical Center,,4.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 05:28:36.040182,2024-10-16 05:28:36.040182,OTHER,,,,,,,2021,1.0
NCT03655444,,2018-08-30,2020-11-09,,2020-11-09,2018-08-30,2018-08-31,ACTUAL,2020-11-09,2020-12-03,ACTUAL,,,,2020-11-09,2020-12-03,ACTUAL,2019-05-29,ACTUAL,2019-05-29,2020-11,2020-11-30,2020-08-24,ACTUAL,2020-08-24,2020-08-24,ACTUAL,2020-08-24,,INTERVENTIONAL,,,Abemaciclib + Nivolumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed or Recurred Within Six Months After Platinum-based Chemotherapy,A Prospective Phase I and II Trial of Abemaciclib + Nivolumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed or Recurred Within Six Months After Platinum-based Chemotherapy,TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,Washington University School of Medicine,,2.0,,Provider of drug decided to discontinue study.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 05:28:36.040182,2024-10-16 05:28:36.040182,OTHER,,,,,,,2020,0.0
NCT03776864,,2018-12-13,2023-01-28,2022-07-22,2023-04-27,2018-12-13,2018-12-17,ACTUAL,2023-04-27,2023-05-03,ACTUAL,,2023-05-03,ACTUAL,2023-04-27,2023-05-03,ACTUAL,2019-09-26,ACTUAL,2019-09-26,2023-04,2023-04-30,2021-09-14,ACTUAL,2021-09-14,2021-09-14,ACTUAL,2021-09-14,,INTERVENTIONAL,,,Umbralisib and Pembrolizumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma,A Phase II Trial of Umbralisib and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma,TERMINATED,,PHASE2,6.0,ACTUAL,University of Washington,,1.0,,Company providing drug terminated their oncology program,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER,,,,,,,2021,0.0
NCT05298202,,2022-03-17,2024-01-23,,2024-03-13,2022-03-17,2022-03-28,ACTUAL,2024-03-13,2024-03-15,ACTUAL,,,,2024-03-13,2024-03-15,ACTUAL,2022-05-25,ACTUAL,2022-05-25,2024-03,2024-03-31,2022-10-01,ACTUAL,2022-10-01,2022-10-01,ACTUAL,2022-10-01,,INTERVENTIONAL,,,The Influence of Capsaicin Gel During Exercise Within the Heat,The Influence of Topical Capsaicin on Thermoregulatory and Perceptual Outcomes During Exercise Within the Heat,COMPLETED,,PHASE4,12.0,ACTUAL,University of Nebraska,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER,,,,,,,2022,1.0
NCT03807882,,2018-11-28,,,2021-06-11,2019-01-16,2019-01-17,ACTUAL,,,,,,,2021-06-11,2021-06-16,ACTUAL,2019-02-01,ACTUAL,2019-02-01,2021-06,2021-06-30,2020-06-30,ACTUAL,2020-06-30,2020-05-31,ACTUAL,2020-05-31,,INTERVENTIONAL,,,Comparison of Maintenance ECT Versus Clozapine in Treatment-resistant Schizophrenia,Comparison of Maintenance ECT Versus Clozapine on Psychopathology and Cerebral Hemodynamics in Treatment-resistant Schizophrenia: A Randomized Controlled Trial,COMPLETED,,PHASE4,60.0,ACTUAL,"All India Institute of Medical Sciences, Bhubaneswar",,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 13:11:46.521972,2024-10-16 13:11:46.521972,OTHER,,,,,,,2020,1.0
NCT03908333,,2019-04-05,,,2019-05-28,2019-04-08,2019-04-09,ACTUAL,,,,,,,2019-05-28,2019-05-30,ACTUAL,2019-05-01,ESTIMATED,2019-05-01,2019-05,2019-05-31,2023-05-01,ESTIMATED,2023-05-01,2022-05-01,ESTIMATED,2022-05-01,,INTERVENTIONAL,,,High Dose Ascorbic Acid and Nanoparticle Paclitaxel Protein Bound and Cisplatin and Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer,Phase IB/II Trial of High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have No Prior Therapy for Their Metastatic Pancreatic Cancer,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Medical College of Wisconsin,,1.0,,Request to close per funding sponsor. Site not moving forward with trial.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 02:59:06.736969,2024-10-15 02:59:06.736969,OTHER,,,,,,,2023,0.0
NCT01285817,,2011-01-06,,,2023-03-09,2011-01-27,2011-01-28,ESTIMATED,,,,,,,2023-03-09,2023-03-13,ACTUAL,2011-01-12,ACTUAL,2011-01-12,2015-10,2015-10-31,2023-03-09,ACTUAL,2023-03-09,2015-09-11,ACTUAL,2015-09-11,,INTERVENTIONAL,SFCE METRO 01,,A Clinical Trial Using Metronomic Oral Low-dose Cyclophosphamide Alternating With Low-dose Oral Methotrexate With Continuous Celecoxib and Weekly Vinblastine in Children and Adolescents With Relapsed or Progressing soliD Tumours.,A Phase II Clinical Trial Using Metronomic Oral Low-dose Cyclophosphamide Alternating With Low-dose Oral Methotrexate With Continuous Celecoxib and Weekly Vinblastine in Children and Adolescents With Relapsed or Progressing Solid Tumours.,COMPLETED,,PHASE2,79.0,ACTUAL,Assistance Publique Hopitaux De Marseille,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2023,1.0
NCT02657356,,2016-01-13,2023-04-25,2021-04-28,2024-02-01,2016-01-14,2016-01-15,ESTIMATED,2023-04-25,2023-05-19,ACTUAL,2021-04-28,2021-04-30,ACTUAL,2024-02-01,2024-02-06,ACTUAL,2016-10-04,ACTUAL,2016-10-04,2024-02,2024-02-29,2020-05-07,ACTUAL,2020-05-07,2020-05-07,ACTUAL,2020-05-07,,INTERVENTIONAL,,Intent to treat (ITT) population (all randomized patients categorized by their assigned treatment group regardless of treatment exposure),Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST,A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension,TERMINATED,,PHASE3,202.0,ACTUAL,Biogen,,2.0,,Exposure of these high-risk patients to clinic or in-person visits during the pandemic presented an unacceptable risk to their health,f,,,,t,,,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-16 13:11:46.521972,2024-10-16 13:11:46.521972,INDUSTRY,,,,,,,2020,0.0
NCT03457025,,2018-01-31,,,2020-05-27,2018-02-28,2018-03-07,ACTUAL,,,,,,,2020-05-27,2020-05-29,ACTUAL,2019-08,ESTIMATED,2019-08-31,2020-05,2020-05-31,2020-06,ESTIMATED,2020-06-30,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,,,Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome,Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,NYU Langone Health,,2.0,,lack of enrollment,f,,,,f,t,f,,,t,,,Immediately following publication. No end date.,Only shared with publication.,,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Only as pertains to study results, will be shared only during publication.",2024-10-16 13:11:46.521972,2024-10-16 13:11:46.521972,OTHER,,,,,,,2020,0.0
NCT01841359,,2013-04-24,2021-11-09,,2023-06-27,2013-04-25,2013-04-26,ESTIMATED,2022-05-03,2022-05-26,ACTUAL,,,,2023-06-27,2023-06-29,ACTUAL,2010-02-02,ACTUAL,2010-02-02,2023-06,2023-06-30,2022-02-08,ACTUAL,2022-02-08,2016-07,ACTUAL,2016-07-31,,INTERVENTIONAL,,Analysis is based upon 14 participants who completed the protocol.,Pramlintide (Symlin) for the Treatment of Hypoglycemia Following Gastric Bypass Surgery,Pramlintide (Symlin) for the Treatment of Hypoglycemia Following Gastric Bypass Surgery,COMPLETED,,PHASE4,22.0,ACTUAL,Joslin Diabetes Center,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 13:11:46.521972,2024-10-16 13:11:46.521972,OTHER,,,,,,,2022,1.0
NCT05489679,,2022-07-15,,,2024-01-23,2022-08-03,2022-08-05,ACTUAL,,,,,,,2024-01-23,2024-01-25,ACTUAL,2022-10-01,ACTUAL,2022-10-01,2024-01,2024-01-31,2023-09-28,ACTUAL,2023-09-28,2023-09-28,ACTUAL,2023-09-28,,INTERVENTIONAL,,,A Study of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer,"A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer",TERMINATED,,PHASE1,6.0,ACTUAL,Accutar Biotechnology Inc,,1.0,,Voluntarily terminate the study since the sponsor's development strategy was adjusted.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 13:11:46.521972,2024-10-16 13:11:46.521972,INDUSTRY,,,,,,,2023,0.0
NCT04397510,,2020-05-19,,,2024-04-02,2020-05-20,2020-05-21,ACTUAL,,,,,,,2024-04-02,2024-04-03,ACTUAL,2020-06-01,ACTUAL,2020-06-01,2024-04,2024-04-30,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Nebulized Heparin for the Treatment of COVID-19 Induced Lung Injury,Nebulized Heparin vs. Placebo for the Treatment of COVID-19 Induced Lung Injury,TERMINATED,,PHASE4,13.0,ACTUAL,Frederick Health,,2.0,,Low enrollment,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2021,0.0
NCT04842747,,2021-04-09,2023-02-23,,2023-03-24,2021-04-09,2021-04-13,ACTUAL,2023-03-24,2023-04-18,ACTUAL,,,,2023-03-24,2023-04-18,ACTUAL,2021-05-18,ACTUAL,2021-05-18,2023-03,2023-03-31,2022-07-06,ACTUAL,2022-07-06,2022-07-06,ACTUAL,2022-07-06,,INTERVENTIONAL,VERU-111,,VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on Study,"Phase 3, Randomized, Placebo-Controlled, Efficacy and Safety Study of VERU-111 for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS).",COMPLETED,,PHASE3,204.0,ACTUAL,Veru Inc.,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,INDUSTRY,,,,,,,2022,1.0
NCT04332107,,2020-03-30,2021-08-09,,2023-02-01,2020-04-01,2020-04-02,ACTUAL,2021-08-31,2021-09-09,ACTUAL,,,,2023-02-01,2023-03-02,ACTUAL,2020-05-22,ACTUAL,2020-05-22,2023-02,2023-02-28,2021-03-30,ACTUAL,2021-03-30,2021-03-16,ACTUAL,2021-03-16,,INTERVENTIONAL,ACTION,A single participant in the Azithromycin group did not have baseline symptom information.,Azithromycin for COVID-19 Treatment in Outpatients Nationwide,Azithromycin for Prevention of Disease Progression in Patients With Mild or Moderate COVID-19,TERMINATED,,PHASE3,263.0,ACTUAL,"University of California, San Francisco","This trial was terminated early by the DSMC for futility on March 16, 2021. Therefore, we were not able to complete the analysis for all secondary outcomes because funds were returned to the sponsor following the completion of the study.~Please note that the number of participants varies by period as participants could opt to complete some questionnaires but not others. For example, a participant may skip the day 3 questionnaire, but complete the day 14 questionnaire.",2.0,,Futility,f,,,,t,t,f,,,f,,,,,,YES,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2021,0.0
NCT04127721,,2019-09-30,,,2020-10-27,2019-10-14,2019-10-16,ACTUAL,,,,,,,2020-10-27,2020-10-29,ACTUAL,2020-09-22,ACTUAL,2020-09-22,2020-10,2020-10-31,2020-09-22,ACTUAL,2020-09-22,2020-09-22,ACTUAL,2020-09-22,,INTERVENTIONAL,,,Itacitinib for the Prevention of Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplantation,Itacitinib to Prevent Graft Versus Host Disease,WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,0 ACTUAL Enrollment must have Overall Recruitment Status,f,,,,f,t,f,,,,,,,,,,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2020,0.0
NCT04549285,,2020-09-08,,,2021-09-07,2020-09-08,2020-09-16,ACTUAL,,,,,,,2021-09-07,2021-09-14,ACTUAL,2021-03-12,ACTUAL,2021-03-12,2021-09,2021-09-30,2022-02-01,ESTIMATED,2022-02-01,2022-02-01,ESTIMATED,2022-02-01,,INTERVENTIONAL,MISTIC,,Infusions of Mesenchymal Stromal Cells in Children With Multisystem Inflammatory Syndrome,A Phase I Pilot Study of the Safety of Infusions of Allogeneic Human Cord Tissue Mesenchymal Stromal Cells in Children With Multisystem Inflammatory Syndrome in Children (MIS-C),WITHDRAWN,,PHASE1,0.0,ACTUAL,Duke University,,1.0,,No accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2022,0.0
NCT03752138,,2018-11-20,,,2019-05-02,2018-11-21,2018-11-23,ACTUAL,,,,,,,2019-05-02,2019-05-06,ACTUAL,2019-03-31,ESTIMATED,2019-03-31,2019-05,2019-05-31,2020-12-31,ESTIMATED,2020-12-31,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,TK216 and Decitabine in Treating Patients With Relapsed and Refractory Acute Myeloid Leukemia,Phase I Study of TK216 in Patients With Relapsed and Refractory Leukemias,WITHDRAWN,,PHASE1,0.0,ACTUAL,M.D. Anderson Cancer Center,,5.0,,The supporting pharamceutical company elected not to pursue this study at this time.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2020,0.0
NCT04384809,,2020-05-07,,,2022-11-16,2020-05-11,2020-05-12,ACTUAL,,,,,,,2022-11-16,2022-11-21,ACTUAL,2023-01-01,ESTIMATED,2023-01-01,2022-11,2022-11-30,2023-05-01,ESTIMATED,2023-05-01,2023-05-01,ESTIMATED,2023-05-01,,INTERVENTIONAL,,,Platelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy,Comparison of Leukocyte-rich Platelet Rich Plasma Injection to Percutaneous Tenotomy in the Treatment of Chronic Common Extensor Tendinopathy,WITHDRAWN,,PHASE4,0.0,ACTUAL,University Hospitals Cleveland Medical Center,,2.0,,Lack of funding,f,,,,f,t,t,,,t,,,,,,,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2023,0.0
NCT03066440,,2017-02-23,2024-06-20,,2024-07-16,2017-02-27,2017-02-28,ACTUAL,2024-07-16,2024-08-06,ACTUAL,,,,2024-07-16,2024-08-06,ACTUAL,2018-09-01,ACTUAL,2018-09-01,2024-07,2024-07-31,2024-03-18,ACTUAL,2024-03-18,2024-03-18,ACTUAL,2024-03-18,,INTERVENTIONAL,,,Double Blinded Randomized Control Trial of Types of IVF in Children With DKA,A Single-center Randomized Double Blinded Control Trial of Intravenous Fluid Content in Children With Diabetic Ketoacidosis Admitted to the Pediatric Intensive Care Unit,TERMINATED,,PHASE4,53.0,ACTUAL,State University of New York at Buffalo,,2.0,,Shortage of potassium acetate for study intravenous fluids,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,OTHER,,,,,,,2024,0.0
NCT03999515,,2019-06-21,2023-07-03,,2023-09-06,2019-06-24,2019-06-26,ACTUAL,2023-09-06,2023-09-28,ACTUAL,,,,2023-09-06,2023-09-28,ACTUAL,2020-04-27,ACTUAL,2020-04-27,2023-09,2023-09-30,2021-06-06,ACTUAL,2021-06-06,2021-06-06,ACTUAL,2021-06-06,,INTERVENTIONAL,,,Erdafitinib and Abiraterone Acetate or Enzalutamide in Treating Patients With Double Negative Prostate Cancer,Erdafitinib Plus Abiraterone Acetate or Enzalutamide in Double Negative Prostate Cancer,TERMINATED,,PHASE2,3.0,ACTUAL,University of Washington,,1.0,,Terminated due to slow accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2021,0.0
NCT03291938,,2017-09-20,,,2020-11-23,2017-09-21,2017-09-25,ACTUAL,,,,,,,2020-11-23,2020-11-24,ACTUAL,2017-11-13,ACTUAL,2017-11-13,2020-11,2020-11-30,2020-11-23,ACTUAL,2020-11-23,2020-11-23,ACTUAL,2020-11-23,,INTERVENTIONAL,,,IACS-010759 in Advanced Cancers,A Phase 1 Study to Evaluate the Safety and Tolerability of IACS-010759 in Subjects With Advanced Solid Tumors and Lymphoma,COMPLETED,,PHASE1,29.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2020,0.0
NCT04890379,,2021-05-10,,,2023-10-24,2021-05-17,2021-05-18,ACTUAL,,,,,,,2023-10-24,2023-10-25,ACTUAL,2021-06-01,ESTIMATED,2021-06-01,2021-05,2021-05-31,2021-12-31,ESTIMATED,2021-12-31,2021-12-31,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage,Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Xuanwu Hospital, Beijing",,2.0,,There are no sufficient patients in the hospital.,f,,,,,f,f,,,,,,,,,,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2021,0.0
NCT05427981,,2022-06-16,,,2023-11-10,2022-06-16,2022-06-22,ACTUAL,,,,,,,2023-11-10,2023-11-14,ACTUAL,2022-10-10,ACTUAL,2022-10-10,2023-11,2023-11-30,2024-01-14,ESTIMATED,2024-01-14,2024-01-14,ESTIMATED,2024-01-14,,INTERVENTIONAL,,,Anti-suicidal Effects of Buprenorphine In Depressed Individuals,Functional Brain Mechanisms Underlying the Anti-Suicidal Effects of Low-dose Buprenorphine in Major Depression,WITHDRAWN,,PHASE3,0.0,ACTUAL,New York State Psychiatric Institute,,2.0,,"U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will not resume recruitment after the resumption of research.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2024,0.0
NCT04412876,,2020-05-31,,,2022-08-14,2020-05-31,2020-06-02,ACTUAL,,,,,,,2022-08-14,2022-08-17,ACTUAL,2020-05-31,ACTUAL,2020-05-31,2021-06,2021-06-30,2021-06-03,ACTUAL,2021-06-03,2020-05-31,ACTUAL,2020-05-31,,INTERVENTIONAL,,,"Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study","Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study",WITHDRAWN,,PHASE3,0.0,ACTUAL,Far Eastern Memorial Hospital,,2.0,,Failed to pass the Ministry of Science and Technology.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,OTHER,,,,,,,2021,0.0
NCT04968158,,2021-07-13,,,2022-04-12,2021-07-13,2021-07-20,ACTUAL,,,,,,,2022-04-12,2022-04-13,ACTUAL,2021-11-29,ACTUAL,2021-11-29,2022-04,2022-04-30,2022-04-10,ACTUAL,2022-04-10,2022-03-15,ACTUAL,2022-03-15,,INTERVENTIONAL,,,Efficacy and Safety of Fixed-dose Combination of Etoricoxib/Tramadol vs Acetaminophen/Tramadol for Acute Low Back Pain,Confirmatory Efficacy and Safety Study of the Fixed-dose Combination of Etoricoxib / Tramadol Versus Acetaminophen / Tramadol for the Management of Acute Low Back Pain.,COMPLETED,,PHASE3,124.0,ACTUAL,Laboratorios Silanes S.A. de C.V.,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,INDUSTRY,,,,,,,2022,1.0
NCT01492582,,2011-12-12,2020-02-06,,2021-10-07,2011-12-13,2011-12-15,ESTIMATED,2020-04-17,2020-04-30,ACTUAL,,,,2021-10-07,2021-10-27,ACTUAL,2012-07,,2012-07-31,2021-10,2021-10-31,2020-07-20,ACTUAL,2020-07-20,2019-02-08,ACTUAL,2019-02-08,,INTERVENTIONAL,,Participants who consented to the study.,Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors,Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial,COMPLETED,,PHASE2,1499.0,ACTUAL,University of Alabama at Birmingham,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,OTHER,,,,,,,2020,1.0
NCT02957682,,2016-10-28,2021-03-02,,2021-04-14,2016-11-03,2016-11-08,ESTIMATED,2021-04-14,2021-05-07,ACTUAL,,,,2021-04-14,2021-05-07,ACTUAL,2016-11-02,ACTUAL,2016-11-02,2021-04,2021-04-30,2020-03-05,ACTUAL,2020-03-05,2020-03-05,ACTUAL,2020-03-05,,INTERVENTIONAL,,"Safety population (SAF) included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered.",Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo,"A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Praluent on Neurocognitive Function in Patients With Heterozygous Familial Hypercholesterolemia or With Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk",COMPLETED,,PHASE4,2176.0,ACTUAL,Regeneron Pharmaceuticals,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,INDUSTRY,,,,,,,2020,1.0
NCT04894994,,2021-05-12,2023-09-13,,2023-12-01,2021-05-17,2021-05-20,ACTUAL,2023-12-01,2023-12-05,ACTUAL,,,,2023-12-01,2023-12-05,ACTUAL,2021-09-03,ACTUAL,2021-09-03,2023-12,2023-12-31,2022-09-13,ACTUAL,2022-09-13,2022-09-13,ACTUAL,2022-09-13,,INTERVENTIONAL,,,FLX475 in Combination With Ipilimumab in Advanced Melanoma,Phase 2 Study of FLX475 in Combination With Ipilimumab in Advanced Melanoma,TERMINATED,,PHASE2,6.0,ACTUAL,"RAPT Therapeutics, Inc.","The study was terminated early due to changes in the treatment landscape of melanoma that have occurred since the initiation of the study, leading to small numbers of subjects analyzed.",1.0,,Change in clinical landscape,f,,,,f,t,f,,,,,,,,,,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,INDUSTRY,,,,,,,2022,0.0
NCT04839237,,2018-03-27,,,2021-04-08,2021-04-08,2021-04-09,ACTUAL,,,,,,,2021-04-08,2021-04-09,ACTUAL,2017-12-01,ACTUAL,2017-12-01,2021-04,2021-04-30,2021-12-01,ESTIMATED,2021-12-01,2020-12-01,ESTIMATED,2020-12-01,,INTERVENTIONAL,,,The Effect and the Pharmacogenomics Study of Liraglutide in Obese Patients,The Effect and the Pharmacogenomics Study of Liraglutide in Obese Patients,WITHDRAWN,,PHASE2,0.0,ACTUAL,Xiangya Hospital of Central South University,,2.0,,The sponsor decides withdrawn this study.,f,,,,,f,f,,,f,,,,,,,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,OTHER,,,,,,,2021,0.0
NCT02758366,,2016-04-27,,,2021-02-04,2016-04-28,2016-05-02,ESTIMATED,,,,,,,2021-02-04,2021-02-09,ACTUAL,2016-02,ACTUAL,2016-02-29,2021-02,2021-02-28,2020-01-16,ACTUAL,2020-01-16,2020-01-16,ACTUAL,2020-01-16,,INTERVENTIONAL,,,Prolonged Exposure to Doxorubicin in Patients With Glioblastoma Multiforme and Diffuse Intrinsic Pontine Glioma,"An Open-label, Single-arm, Phase II Study to Evaluate Safety and Efficacy of Doxorubicin in Combination With Radiotherapy, Temozolomide and Valproic Acid in Patients With Glioblastoma Multiforme (GBM) and Diffuse Intrinsic Pontine Glioma (DIPG)",TERMINATED,,PHASE2,21.0,ACTUAL,Meyer Children's Hospital IRCCS,,1.0,,Study was terminated due to high heterogeneity of enrolled patients,f,,,,f,,,,,,,,,,,,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,OTHER,,,,,,,2020,0.0
NCT03705169,,2018-10-10,2023-10-27,,2024-01-10,2018-10-10,2018-10-15,ACTUAL,2024-01-10,2024-01-12,ACTUAL,,,,2024-01-10,2024-01-12,ACTUAL,2019-05-20,ACTUAL,2019-05-20,2024-01,2024-01-31,2022-04-04,ACTUAL,2022-04-04,2022-04-04,ACTUAL,2022-04-04,,INTERVENTIONAL,,"Only participants receiving study treatment were included in the analysis. For analysis, participants receiving placebo (of any dose-volume equivalent) are pooled within arm per the pre-specified analysis plan.",Pharmacokinetics and Safety of SAR441236,"A Phase I, First-in-Human Study of SAR441236, a Tri-specific Broadly Neutralizing Antibody, in Participants With HIV",TERMINATED,,PHASE1,52.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),"The dosing schedule for many Arm A Cohort 4 participants was interrupted by the COVID-19 pandemic and associated study pause. Enrollment in Arm B was limited. Protocol V3.0 closed the 1 mg/kg cohort and opened the 30 mg/kg cohort. Protocol V4.0 modified the eligibility criteria to boost enrollment but, despite the study remaining open through April 2023, no more participants enrolled. Neither Arm B cohort fully enrolled and the intermediate dose cohorts (3 and 10 mg/kg) did not open.",10.0,,"The study closed to enrollment and follow-up in May 2023. There had been no enrollment since October 2021, and by 2023, the available study product had reached its expiration date. Enrollment targets in Arm B had not been met.",f,,,,t,t,f,,,,,,Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.,* With whom?~  * Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses?~  * To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism will data be made available?~  * Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at: https://submit.mis.s-3.net/ Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.,,YES,"Individual participant data that underlie results in the publication, after deidentification.",2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,NIH,,,,,,,2022,0.0
NCT02801448,,2016-06-12,,,2022-01-14,2016-06-14,2016-06-15,ESTIMATED,,,,,,,2022-01-14,2022-01-19,ACTUAL,2015-09,,2015-09-30,2022-01,2022-01-31,2020-06,ACTUAL,2020-06-30,2020-06,ACTUAL,2020-06-30,,INTERVENTIONAL,,,Clinical Trial With Broccoli Sprout Extract to Patients With Type 2 Diabetes,Randomized Clinical Trial With Broccoli Sprout Extract to Patients With Type 2 Diabetes,COMPLETED,,PHASE2,103.0,ACTUAL,Region Skane,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,OTHER,,,,,,,2020,1.0
NCT04470622,,2020-07-13,2022-04-08,,2022-08-08,2020-07-13,2020-07-14,ACTUAL,2022-08-08,2022-08-30,ACTUAL,,,,2022-08-08,2022-08-30,ACTUAL,2020-07-20,ACTUAL,2020-07-20,2022-08,2022-08-31,2021-06-03,ACTUAL,2021-06-03,2021-04-09,ACTUAL,2021-04-09,,INTERVENTIONAL,,Safety Population.,Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1),"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Aprepitant Injectable Emulsion in Early Hospitalized Adult Patients With COVID-19",TERMINATED,,PHASE2,27.0,ACTUAL,Heron Therapeutics,"Study was terminated early by Heron, and was not terminated for safety reasons. The data reported is only safety data generated from the study.",2.0,,"Study was terminated early by Heron, and was not terminated for safety reasons.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,INDUSTRY,,,,,,,2021,0.0
NCT04071626,,2019-08-26,2023-10-12,,2023-12-11,2019-08-26,2019-08-28,ACTUAL,2023-12-11,2023-12-13,ACTUAL,,,,2023-12-11,2023-12-13,ACTUAL,2020-03-01,ACTUAL,2020-03-01,2023-12,2023-12-31,2023-01-11,ACTUAL,2023-01-11,2023-01-11,ACTUAL,2023-01-11,,INTERVENTIONAL,EMMED-HF,,Evaluating Metabolic Mechanisms of Ertugliflozin in Diabetes & Heart Failure,The EMMED-HF Study: Evaluating Metabolic Mechanisms of Ertugliflozin in Diabetes & Heart Failure,TERMINATED,,PHASE4,9.0,ACTUAL,University Hospitals Cleveland Medical Center,,2.0,,Lack of enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,OTHER,,,,,,,2023,0.0
NCT04345471,,2020-04-06,2023-05-23,,2024-02-27,2020-04-10,2020-04-14,ACTUAL,2024-02-27,2024-02-29,ACTUAL,,,,2024-02-27,2024-02-29,ACTUAL,2020-05-18,ACTUAL,2020-05-18,2024-02,2024-02-29,2022-09-14,ACTUAL,2022-09-14,2022-07-21,ACTUAL,2022-07-21,,INTERVENTIONAL,,,A Study of MD-120 in Patients With Depression,A Placebo-controlled Study of MD-120 in Patients With Depression,COMPLETED,,PHASE3,615.0,ACTUAL,"Mochida Pharmaceutical Company, Ltd.",,3.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,INDUSTRY,,,,,,,2022,1.0
NCT02624518,,2015-11-30,2023-02-04,,2023-04-06,2015-12-04,2015-12-08,ESTIMATED,2023-04-06,2023-04-10,ACTUAL,,,,2023-04-06,2023-04-10,ACTUAL,2015-11-16,ACTUAL,2015-11-16,2023-04,2023-04-30,2022-11,ACTUAL,2022-11-30,2021-07-21,ACTUAL,2021-07-21,,INTERVENTIONAL,,,68Ga-RM2 PET/MRI in Biochemically Recurrent Prostate Cancer,68Ga-RM2 PET/MRI in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer and Non-contributory CT Scans,COMPLETED,,PHASE2/PHASE3,122.0,ACTUAL,Stanford University,,1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,OTHER,,,,,,,2022,1.0
NCT03557970,,2018-06-05,2021-09-22,,2021-12-01,2018-06-05,2018-06-15,ACTUAL,2021-12-01,2021-12-02,ACTUAL,,,,2021-12-01,2021-12-02,ACTUAL,2018-10-05,ACTUAL,2018-10-05,2021-12,2021-12-31,2020-09-28,ACTUAL,2020-09-28,2020-09-28,ACTUAL,2020-09-28,,INTERVENTIONAL,,,JNJ-40346527 in Treating Participants With Relapsed or Refractory Acute Myeloid Leukemia,A Phase 2 Open-Label Study of the CSF-1R Inhibitor JNJ-40346527 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML),TERMINATED,,PHASE2,3.0,ACTUAL,OHSU Knight Cancer Institute,,1.0,,Not enough enrollment to determine efficacy,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2020,0.0
NCT02832544,,2015-12-10,,,2022-10-03,2016-07-11,2016-07-14,ESTIMATED,,,,,,,2022-10-03,2022-10-05,ACTUAL,2016-08-22,ACTUAL,2016-08-22,2022-07,2022-07-31,2022-08-18,ACTUAL,2022-08-18,2022-08-18,ACTUAL,2022-08-18,,INTERVENTIONAL,INVICTUS-VKA,,"INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Non-Inferiority","INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies",COMPLETED,,PHASE3,4565.0,ACTUAL,Population Health Research Institute,,2.0,,,f,,,,t,,,,,,,,,,,NO,cumulative participant data only,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2022,1.0
NCT04673214,,2020-12-16,2021-03-08,,2021-08-12,2020-12-16,2020-12-17,ACTUAL,2021-08-12,2021-08-16,ACTUAL,,,,2021-08-12,2021-08-16,ACTUAL,2020-12-16,ACTUAL,2020-12-16,2021-08,2021-08-31,2021-02-25,ACTUAL,2021-02-25,2021-02-25,ACTUAL,2021-02-25,,INTERVENTIONAL,,"Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%; A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis.",Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment,Prognostic Modification in Patients With COVID-19 Under Early Intervention Treatment at U.M.F 13 and U.M.F 20,COMPLETED,,PHASE3,114.0,ACTUAL,"Coordinación de Investigación en Salud, Mexico",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,SHARED VIA EMAIL IF OTHER RESEARCHERS REQUIRE IT,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER_GOV,,,,,,,2021,1.0
NCT05127811,,2021-09-18,,,2023-05-30,2021-11-08,2021-11-19,ACTUAL,,,,,,,2023-05-30,2023-06-02,ACTUAL,2021-10-21,ACTUAL,2021-10-21,2023-05,2023-05-31,2023-05-26,ACTUAL,2023-05-26,2023-05-26,ACTUAL,2023-05-26,,INTERVENTIONAL,,,A Phase I Study of ZN-d5 in Chinese Subjects With Non-Hodgkin Lymphoma,A Phase I Dose Escalation Study of ZN-d5 Monotherapy in Chinese Subjects With Non-Hodgkin Lymphoma,TERMINATED,,PHASE1,8.0,ACTUAL,Zentera Therapeutics HK Limited,,6.0,,Sponsor's decision,f,,,,f,t,f,,,t,,,,,,UNDECIDED,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,INDUSTRY,,,,,,,2023,0.0
NCT04006847,,2019-07-02,2022-05-12,,2022-06-07,2019-07-02,2019-07-05,ACTUAL,2022-06-07,2022-07-01,ACTUAL,,,,2022-06-07,2022-07-01,ACTUAL,2020-09-14,ACTUAL,2020-09-14,2022-06,2022-06-30,2021-05-21,ACTUAL,2021-05-21,2021-05-21,ACTUAL,2021-05-21,,INTERVENTIONAL,,,Omega -3 Fatty Acid in Combination With Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia,"Effect of Omega-3 Fatty Acid, Eicosapentaenoic Acid, and Its Metabolites in Combination With Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia in Stable Chronic Phase",TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,Milton S. Hershey Medical Center,"Due to the product issues, the trials was halted.",1.0,,Product complaint,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,OTHER,,,,,,,2021,0.0
NCT03705351,,2018-10-08,2022-05-05,,2023-08-02,2018-10-11,2018-10-15,ACTUAL,2023-08-02,2024-03-04,ACTUAL,,,,2023-08-02,2024-03-04,ACTUAL,2019-12-02,ACTUAL,2019-12-02,2023-08,2023-08-31,2022-02-24,ACTUAL,2022-02-24,2021-02-24,ACTUAL,2021-02-24,,INTERVENTIONAL,,Newly diagnosed patients histologically confirmed glioblastoma after maximally safe resection,Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM,Safety and Tolerability of Tumor Treating Fields (TTFields) Combined With Chemoradiation in Newly Diagnosed Glioblastoma (Unity),TERMINATED,,PHASE1,7.0,ACTUAL,Providence Health & Services,Early termination leading to small numbers of subjects analyzed,1.0,,Prinicipal Investigator departure from institution,f,,,,t,t,t,,,,,,,,,NO,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,OTHER,,,,,,,2022,0.0
NCT05710315,,2023-01-24,,,2023-04-21,2023-01-24,2023-02-02,ACTUAL,,,,,,,2023-04-21,2023-04-25,ACTUAL,2023-05-01,ESTIMATED,2023-05-01,2023-04,2023-04-30,2024-01-30,ESTIMATED,2024-01-30,2023-07-30,ESTIMATED,2023-07-30,,INTERVENTIONAL,,,Use of ReliZORB for Feeding Intolerance in Critically Ill Patients,"Single-center, Open-label, Prospective Randomized (Double-Blind) Study on the Use of ReliZORB™ for the Treatment of Feeding Intolerance in Critically Ill Adults With Multi Organ Failure",WITHDRAWN,,PHASE4,0.0,ACTUAL,Duke University,,2.0,,PI initiated study closure. He will be leaving the study site for a new position in the coming months.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,OTHER,,,,,,,2024,0.0
NCT04158830,,2019-10-18,,,2020-11-11,2019-11-07,2019-11-12,ACTUAL,,,,,,,2020-11-11,2020-11-13,ACTUAL,2020-06-01,ESTIMATED,2020-06-01,2020-11,2020-11-30,2021-11-30,ESTIMATED,2021-11-30,2021-11-30,ESTIMATED,2021-11-30,,INTERVENTIONAL,,,Aspirin (ASA) Therapy and Preeclampsia Prevention,A Pragmatic Randomized Study Comparing 81 mg Aspirin Versus 162 mg Aspirin in the Prevention of Preeclampsia During Pregnancy,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Tennessee,,2.0,,PI is no longer at this University.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 13:17:39.160219,2024-10-16 13:17:39.160219,OTHER,,,,,,,2021,0.0
NCT03500939,,2018-03-27,,,2022-09-21,2018-04-09,2018-04-18,ACTUAL,,,,,,,2022-09-21,2022-09-23,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2022-09,2022-09-30,2022-08-22,ACTUAL,2022-08-22,2022-05-16,ACTUAL,2022-05-16,,INTERVENTIONAL,PROOF,,Penumbral Rescue by Normobaric O2 Administration in Patients With Ischemic Stroke and Target Mismatch ProFile,Penumbral Rescue by Normobaric O=O Administration in Patients With Ischemic Stroke and Target Mismatch ProFile: A Phase II Proof-of-Concept Trial,TERMINATED,,PHASE2,223.0,ACTUAL,University Hospital Tuebingen,,2.0,,Futility,f,,,,t,f,f,,,,,,,,,,,2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,OTHER,,,,,,,2022,0.0
NCT02675426,,2015-12-11,2019-09-13,2018-01-09,2023-03-17,2016-02-03,2016-02-05,ESTIMATED,2019-09-13,2019-10-07,ACTUAL,2018-01-15,2018-01-17,ACTUAL,2023-03-17,2023-04-11,ACTUAL,2015-12-17,ACTUAL,2015-12-17,2023-03,2023-03-31,2022-03-10,ACTUAL,2022-03-10,2017-04-21,ACTUAL,2017-04-21,,INTERVENTIONAL,SELECT-NEXT,The Full Analysis Set (FAS) includes all randomized participants who received at least one dose of study drug.~The two placebo groups are combined for analysis of results in Period 1.,A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone,"A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs",COMPLETED,,PHASE3,661.0,ACTUAL,AbbVie,,4.0,,,f,,,,t,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,INDUSTRY,,,,,,,2022,1.0
NCT02499354,,2015-07-13,2023-07-19,,2024-01-29,2015-07-14,2015-07-16,ESTIMATED,2023-07-24,2023-08-15,ACTUAL,,,,2024-01-29,2024-01-30,ACTUAL,2014-08,ACTUAL,2014-08-31,2024-01,2024-01-31,2022-05-31,ACTUAL,2022-05-31,2021-09-28,ACTUAL,2021-09-28,,INTERVENTIONAL,,,"Pilot Study: Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of RLS With IDA. (IVOR-IDA)",Double-blind Comparator of Efficacy of Oral (Ferrous Sulfate) vs. Intravenous Iron (Ferumoxytol) for Treatment of the Restless Legs Syndrome (RLS) Occurring With Iron Deficient Anemia (IDA),COMPLETED,,PHASE2,100.0,ACTUAL,Auerbach Hematology Oncology Associates P C,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,OTHER,,,,,,,2022,1.0
NCT05441826,,2022-06-07,,,2024-04-18,2022-06-28,2022-07-01,ACTUAL,,,,,,,2024-04-18,2024-04-22,ACTUAL,2022-05-03,ACTUAL,2022-05-03,2024-04,2024-04-30,2023-10-12,ACTUAL,2023-10-12,2023-05-03,ACTUAL,2023-05-03,,INTERVENTIONAL,,,Efficacy and Safety of VB119 in Subjects With Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS),A Phase 2 Study of VB119 in Adult Subjects With Steroid-Sensitive Primary Minimal Change Disease (MCD) or Primary Focal Segmental Glomerulosclerosis (FSGS),TERMINATED,,PHASE2,1.0,ACTUAL,Tenet Medicines,,1.0,,Sponsor change,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,INDUSTRY,,,,,,,2023,0.0
NCT05330013,,2022-04-14,,,2022-06-23,2022-04-14,2022-04-15,ACTUAL,,,,,,,2022-06-23,2022-06-27,ACTUAL,2022-06-23,ACTUAL,2022-06-23,2022-06,2022-06-30,2022-06-23,ACTUAL,2022-06-23,2022-06-23,ACTUAL,2022-06-23,,INTERVENTIONAL,,,The Effect of Inflammation in Heart Failure,Pilot Study to Evaluate the Effect of Inflammation in Heart Failure,WITHDRAWN,,PHASE2,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,PI left NIH,f,,,,,f,f,,,,,,,,,,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,NIH,,,,,,,2022,0.0
NCT05087771,,2021-09-27,,,2023-04-05,2021-10-08,2021-10-21,ACTUAL,,,,,,,2023-04-05,2023-04-07,ACTUAL,2022-03,ESTIMATED,2022-03-31,2023-04,2023-04-30,2023-06,ESTIMATED,2023-06-30,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,IM-NTX,,In Hospital IM Naltrexone: A Pilot Study,In Hospital Administration of Extended-Release Naltrexone for Alcohol Use Disorder: A Pilot Study of Feasibility and Acceptability,WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of Colorado, Denver",,2.0,,"no longer randomized, drug being offered to all patients",f,,,,t,t,f,,,t,,,,,,NO,This is not part of our study protocol and will not be included as part of the consent for study participation.,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2023,0.0
NCT04551352,,2020-08-26,,,2022-09-30,2020-09-10,2020-09-16,ACTUAL,,,,,,,2022-09-30,2022-10-03,ACTUAL,2020-10-28,ACTUAL,2020-10-28,2022-09,2022-09-30,2022-07-28,ACTUAL,2022-07-28,2022-07-28,ACTUAL,2022-07-28,,INTERVENTIONAL,,,A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas,"An Open-Label, Multicenter, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7293583, A TYRP1-Targeting CD3 T-Cell Engager, in Participants With Metastatic Melanoma",COMPLETED,,PHASE1,20.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,INDUSTRY,,,,,,,2022,0.0
NCT05198349,,2022-01-05,,,2023-10-17,2022-01-05,2022-01-20,ACTUAL,,,,,,,2023-10-17,2023-10-19,ACTUAL,2022-03-02,ACTUAL,2022-03-02,2023-10,2023-10-31,2023-08-10,ACTUAL,2023-08-10,2023-05-09,ACTUAL,2023-05-09,,INTERVENTIONAL,,,First in Human Study of M1069 in Advanced Solid Tumors,"First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of M1069 in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors",TERMINATED,,PHASE1,15.0,ACTUAL,EMD Serono,,1.0,,Overarching portfolio-level review of the company's oncology pipeline resulted in early termination of the study. The study was not terminated due to safety.,f,,,,,t,f,,,,,,,,,NO,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://bit.ly/IPD21",2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,INDUSTRY,,,,,,,2023,0.0
NCT03119064,,2017-04-06,2021-08-23,,2022-11-17,2017-04-13,2017-04-18,ACTUAL,2022-02-01,2022-02-24,ACTUAL,,,,2022-11-17,2022-12-13,ACTUAL,2017-11-30,ACTUAL,2017-11-30,2022-11,2022-11-30,2021-10-08,ACTUAL,2021-10-08,2020-04-10,ACTUAL,2020-04-10,,INTERVENTIONAL,329,,BrUOG 329 Onivyde & Metronomic Temozolomide in Recurrent Glioblastoma,BrUOG 329: Onivyde (Nanoliposomal Irinotecan) and Metronomic Temozolomide for Patients With Recurrent Glioblastoma: A Phase IB/IIA Brown University Oncology Research Group Study,TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,Brown University,,3.0,,lack of response to study therapy,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,OTHER,,,,,,,2021,0.0
NCT05364099,,2022-05-03,,,2023-11-29,2022-05-03,2022-05-06,ACTUAL,,,,,,,2023-11-29,2023-12-06,ACTUAL,2023-11-27,ACTUAL,2023-11-27,2023-11,2023-11-30,2024-01-01,ESTIMATED,2024-01-01,2024-01-01,ESTIMATED,2024-01-01,,INTERVENTIONAL,,,Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries,Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Miami,,1.0,,Unable to feasibly complete study.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,OTHER,,,,,,,2024,0.0
NCT04071366,,2019-08-26,2024-01-26,,2024-02-26,2019-08-26,2019-08-28,ACTUAL,2024-02-26,2024-03-26,ACTUAL,,,,2024-02-26,2024-03-26,ACTUAL,2020-02-07,ACTUAL,2020-02-07,2024-02,2024-02-29,2023-08-22,ACTUAL,2023-08-22,2023-02-23,ACTUAL,2023-02-23,,INTERVENTIONAL,,,A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy,"A Phase 2 Study of Itacitinib, for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy",COMPLETED,,PHASE2,112.0,ACTUAL,Incyte Corporation,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,INDUSTRY,,,,,,,2023,1.0
NCT04998253,,2021-05-19,,,2021-08-09,2021-08-07,2021-08-10,ACTUAL,,,,,,,2021-08-09,2021-08-13,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2021-08,2021-08-31,2021-05-15,ACTUAL,2021-05-15,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,COVID-19,,Effects in Oxygenation and Hypoxic Pulmonary Vasoconstriction in ARDS Secondary to SARS-CoV2,A Randomized Pilot Clinical Trial of the Effects in Oxygenation and Hypoxic Pulmonary Vasoconstriction of Sevoflurane in Patient's Whit ARDS Secondary to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2),COMPLETED,,EARLY_PHASE1,24.0,ACTUAL,Unidad Temporal COVID-19 en Centro Citibanamex,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,OTHER,,,,,,,2021,1.0
NCT02015923,,2013-11-28,,,2021-03-12,2013-12-13,2013-12-19,ESTIMATED,,,,,,,2021-03-12,2021-03-16,ACTUAL,2013-12,,2013-12-31,2021-03,2021-03-31,2020-02,ACTUAL,2020-02-29,2019-06,ACTUAL,2019-06-30,,INTERVENTIONAL,CCRe-IV,,Resection vs no Resection of the Primary in Colorectal Cancer With Unresectable Metastases,Multicenter Randomized Study in Patients With Colorectal Cancer With Unresectable Metastases. Impact of Resection vs no Resection of the Primary Tumour as a Survival Factor,TERMINATED,,PHASE4,107.0,ACTUAL,Hospital Universitari de Bellvitge,,2.0,,Difficulties surrounding recruiting patients,f,,,,t,,,,,,,,,,,,,2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,OTHER,,,,,,,2020,0.0
NCT05482672,,2022-07-26,,,2023-04-27,2022-07-28,2022-08-01,ACTUAL,,,,,,,2023-04-27,2023-05-01,ACTUAL,2023-04,ESTIMATED,2023-04-30,2023-04,2023-04-30,2023-04,ESTIMATED,2023-04-30,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,,,"GetHealthy-OA: A Program to Improve Pain and Function for Patients With Knee Osteoarthritis, Obesity, and Depression","GetHealthy-OA: A Biopsychosocial Treatment Approach to Improve Pain and Function for Patients With Comorbid Knee Osteoarthritis, Obesity, and Depression",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Brigham and Women's Hospital,,2.0,,Lack of funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,OTHER,,,,,,,2023,0.0
NCT02798068,,2016-05-25,,,2024-06-28,2016-06-08,2016-06-14,ESTIMATED,,,,,,,2024-06-28,2024-07-01,ACTUAL,2016-05,,2016-05-31,2021-09,2021-09-30,2021-09,ACTUAL,2021-09-30,2021-09,ACTUAL,2021-09-30,,INTERVENTIONAL,SICS,,Steroids and Microcirculation In Cardiac Surgery,"Evaluation of High-dose Corticosteroids on Microcirculation Alterations in Cardiac Surgery, by FMD (Flow Mediated vasoDilation), Near Infrared Spectrophotometry (NIRS) and Biological Analysis (Syndecan-1)",TERMINATED,,PHASE4,40.0,ACTUAL,Erasme University Hospital,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,OTHER,,,,,,,2021,0.0
NCT02762097,,2016-04-30,,,2018-11-03,2016-05-02,2016-05-04,ESTIMATED,,,,,,,2018-11-03,2018-11-06,ACTUAL,2017-01-30,ESTIMATED,2017-01-30,2018-11,2018-11-30,2020-01-30,ESTIMATED,2020-01-30,2020-01-30,ESTIMATED,2020-01-30,,INTERVENTIONAL,,,Clinical Pregnancy Rate After Removal of Unsuspected Polyps,Clinical Pregnancy Rate in Women With Unexplained Infertility After Removal of Unsuspected Intrauterine Pathology,WITHDRAWN,,PHASE3,0.0,ACTUAL,Karachi Medical and Dental College,,2.0,,Study stopped due to similar case control study already completed,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,OTHER,,,,,,,2020,0.0
NCT02902484,,2016-09-02,2024-02-23,,2024-05-15,2016-09-14,2016-09-15,ESTIMATED,2024-05-15,2024-06-03,ACTUAL,,,,2024-05-15,2024-06-03,ACTUAL,2017-09-07,ACTUAL,2017-09-07,2024-05,2024-05-31,2021-10-26,ACTUAL,2021-10-26,2021-10-26,ACTUAL,2021-10-26,,INTERVENTIONAL,,,Study of Nintedanib and Chemotherapy for Advanced Pancreatic Cancer,A Phase 1b and Pharmacodynamic Study of Nintedanib Monotherapy for Advanced Pancreatic Cancer,TERMINATED,,PHASE1/PHASE2,14.0,ACTUAL,University of Texas Southwestern Medical Center,,1.0,,The study was terminated due to futility and lack of future funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,OTHER,,,,,,,2021,0.0
NCT04108377,,2019-09-26,,,2023-10-20,2019-09-26,2019-09-30,ACTUAL,,,,,,,2023-10-20,2023-10-24,ACTUAL,2019-01-21,ACTUAL,2019-01-21,2023-05,2023-05-31,2023-08-15,ACTUAL,2023-08-15,2022-12-11,ACTUAL,2022-12-11,,INTERVENTIONAL,,,"Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma","Phosphodiesterase 4 Inhibitor, Roflumilast, Improves Beta Agonist Responsiveness Compared to Placebo in Low T2 Asthma Patients.",TERMINATED,,PHASE1,5.0,ACTUAL,"University of California, Davis",,2.0,,Enrollment stopped secondary to completion of funding,f,,,,,t,f,,,t,,,,,,,,2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,OTHER,,,,,,,2023,0.0
NCT03903640,,2019-04-03,2022-03-21,,2022-05-12,2019-04-03,2019-04-04,ACTUAL,2022-04-19,2022-05-12,ACTUAL,,,,2022-05-12,2022-06-07,ACTUAL,2019-10-14,ACTUAL,2019-10-14,2022-05,2022-05-31,2021-11-03,ACTUAL,2021-11-03,2020-06-08,ACTUAL,2020-06-08,,INTERVENTIONAL,,,Optune Device - TT Field Plus Nivolumab and Ipilimumab for Melanoma With Brain Metastasis,Phase II Study of Optune Device - TT Field Plus Nivolumab and Ipilimumab for Melanoma With Brain Metastasis,TERMINATED,,PHASE2,2.0,ACTUAL,Washington University School of Medicine,The study was opened to enrollment from 07/01/2019 through 03/09/2022. The study was terminated early due to low enrollment. The low enrollment was due to the COVID-19 pandemic and no external referrals for the trial. The Principal Investigator reached out to other academic institutions about opening the trial but there was not any interest.,1.0,,The study was terminated early on 03/09/2022 due to low accrual during the COVID-19 pandemic.,f,,,,t,t,t,,,f,,,,,,NO,,2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,OTHER,,,,,,,2021,0.0
NCT04330300,,2020-03-30,,,2020-06-26,2020-03-30,2020-04-01,ACTUAL,,,,,,,2020-06-26,2020-06-30,ACTUAL,2020-04-30,ACTUAL,2020-04-30,2020-06,2020-06-30,2021-12-01,ESTIMATED,2021-12-01,2021-07-31,ESTIMATED,2021-07-31,,INTERVENTIONAL,CORONACION,,Coronavirus (COVID-19) ACEi/ARB Investigation,The CORONAvirus Disease 2019 Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker InvestigatiON (CORONACION) Randomized Clinical Trial,SUSPENDED,,PHASE4,2414.0,ESTIMATED,"National University of Ireland, Galway, Ireland",,2.0,,Challenges with funding and very low incidence of COVID-19 at Irish study site,f,,,,t,f,f,,,f,,,12-24 months,To be determined,,YES,,2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,OTHER,,,,,,,2021,0.0
NCT04351191,,2020-04-14,,,2021-03-08,2020-04-15,2020-04-17,ACTUAL,,,,,,,2021-03-08,2021-03-10,ACTUAL,2020-04-15,ACTUAL,2020-04-15,2021-03,2021-03-31,2020-08-30,ACTUAL,2020-08-30,2020-08-23,ACTUAL,2020-08-23,,INTERVENTIONAL,PRECISE,,PRophylaxis of Exposed COVID-19 Individuals With Mild Symptoms Using choloroquinE Compounds,Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Symptomatic RT-PCR Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Infectious Disease 2019 (COVID-19) Patients to RT- PCR-Negative as a Means to Reduce Hospitalization Rate,TERMINATED,,PHASE4,137.0,ACTUAL,"Government of Punjab, Specialized Healthcare and Medical Education Department",,4.0,,Poor accrual,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,OTHER_GOV,,,,,,,2020,0.0
NCT02945280,,2016-09-27,,,2023-09-26,2016-10-24,2016-10-26,ESTIMATED,,,,,,,2023-09-26,2023-09-28,ACTUAL,2017-02-22,ACTUAL,2017-02-22,2023-09,2023-09-30,2021-11-11,ACTUAL,2021-11-11,2021-11-11,ACTUAL,2021-11-11,,INTERVENTIONAL,ARM-DVT,,Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis,Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis,TERMINATED,,PHASE4,52.0,ACTUAL,"Intermountain Health Care, Inc.",,1.0,,COVID-19 resource allocation,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,OTHER,,,,,,,2021,0.0
NCT04602390,,2020-10-05,,,2024-07-26,2020-10-20,2020-10-26,ACTUAL,,,,,,,2024-07-26,2024-07-29,ACTUAL,2020-11-06,ACTUAL,2020-11-06,2024-07,2024-07-31,2024-04-23,ACTUAL,2024-04-23,2024-04-23,ACTUAL,2024-04-23,,INTERVENTIONAL,MoveS-it,,Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis,A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis,COMPLETED,,PHASE1,33.0,ACTUAL,Anokion SA,,5.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,INDUSTRY,,,,,,,2024,1.0
NCT04262869,,2020-02-07,,,2021-10-26,2020-02-07,2020-02-10,ACTUAL,,,,,,,2021-10-26,2021-10-27,ACTUAL,2020-03-27,ACTUAL,2020-03-27,2021-10,2021-10-31,2021-10-18,ACTUAL,2021-10-18,2021-10-18,ACTUAL,2021-10-18,,INTERVENTIONAL,,,Platinum-Based Chemotherapy and Durvalumab for the Treatment of Stage IIIB or IV Non-small Cell Lung Cancer,Phase 2 Study of Platinum-Based Chemotherapy in Combination With Durvalumab (MEDI 4736) for NSCLC in Patients With a Poor Performance Status and the Elderly,WITHDRAWN,,PHASE2,0.0,ACTUAL,Emory University,,2.0,,Due to accrual issues,f,,,,t,t,f,,,,,,,,,NO,"Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.",2024-10-16 13:23:28.189409,2024-10-16 13:23:28.189409,OTHER,,,,,,,2021,0.0
NCT02939365,,2016-10-18,,,2022-12-02,2016-10-19,2016-10-20,ESTIMATED,,,,,,,2022-12-02,2022-12-06,ACTUAL,2019-02,ESTIMATED,2019-02-28,2022-12,2022-12-31,2022-12,ESTIMATED,2022-12-31,2020-02,ESTIMATED,2020-02-29,,INTERVENTIONAL,PROBE,,Precision Medicine Offers Belatacept Monotherapy,Precision Medicine Offers Belatacept Monotherapy (PROBE),WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of California, San Francisco",,1.0,,Because of inability to get FDA approval for,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2022,0.0
NCT03720483,,2018-07-18,,,2021-06-03,2018-10-23,2018-10-25,ACTUAL,,,,,,,2021-06-03,2021-06-08,ACTUAL,2022-01,ESTIMATED,2022-01-31,2021-06,2021-06-30,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Inhaled NAC in Treatment of IPF,Pilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary Fibrosis,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"University of Colorado, Denver",,2.0,,The study encountered challenges during startup due to the COVID-19 epidemic and was withdrawn.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,OTHER,,,,,,,2023,0.0
NCT03770000,,2018-12-06,2022-05-04,,2022-10-27,2018-12-06,2018-12-10,ACTUAL,2022-10-27,2022-10-28,ACTUAL,,,,2022-10-27,2022-10-28,ACTUAL,2019-03-12,ACTUAL,2019-03-12,2022-10,2022-10-31,2021-05-14,ACTUAL,2021-05-14,2021-05-14,ACTUAL,2021-05-14,,INTERVENTIONAL,,,Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma,"An Open Label, Phase I/II Study to Evaluate the Safety and Efficacy of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor Given in Combination With a Histone Deacetylase (HDAC) Inhibitor, Romidepsin in Adult Patients With Relapsed/Refractory T-cell Lymphoma",COMPLETED,,PHASE1/PHASE2,33.0,ACTUAL,Rhizen Pharmaceuticals SA,,1.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,INDUSTRY,,,,,,,2021,1.0
NCT03883581,,2019-03-12,2022-09-12,,2023-02-08,2019-03-19,2019-03-21,ACTUAL,2023-02-08,2023-03-08,ACTUAL,,,,2023-02-08,2023-03-08,ACTUAL,2019-07-25,ACTUAL,2019-07-25,2023-02,2023-02-28,2021-11-22,ACTUAL,2021-11-22,2021-09-13,ACTUAL,2021-09-13,,INTERVENTIONAL,,,Impact of Nuedexta on Bulbar Physiology and Function in ALS,Impact of Nuedexta on Bulbar Physiology and Function in ALS,COMPLETED,,PHASE1/PHASE2,28.0,ACTUAL,University of Florida,,1.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2021,1.0
NCT03689582,,2018-09-27,2021-10-14,2021-08-19,2021-12-07,2018-09-27,2018-09-28,ACTUAL,2021-12-07,2022-01-05,ACTUAL,2021-12-07,2022-01-05,ACTUAL,2021-12-07,2022-01-05,ACTUAL,2018-11-13,ACTUAL,2018-11-13,2021-12,2021-12-31,2020-02-27,ACTUAL,2020-02-27,2020-02-27,ACTUAL,2020-02-27,,INTERVENTIONAL,,,Radiolabeled Gallium-68 (68Ga-PSMA) for PET/CT Imaging to Detect Prostate Cancer,68GA-PSMA Fusion PET/MRI For Image-Guided Prostate Biopsies,TERMINATED,,PHASE2,11.0,ACTUAL,University of Michigan Rogel Cancer Center,Early termination leading to small numbers of subjects analyzed.,1.0,,due to pandemic related constraints,f,,,,,t,f,,,,,,Available as requested. Data will be archived indefinitely for research purposes.,Individuals seeking use of these data should contact the study chair.,,YES,Codified data will be archived and stored in an imaging repository with limited metadata for analysis. Individuals seeking use of these data should contact the study chair. A data sharing contract for a HIPAA limited dataset will need to be executed prior to data sharing.,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2020,0.0
NCT03237611,,2017-07-31,2023-09-22,,2023-11-09,2017-08-01,2017-08-02,ACTUAL,2023-11-08,2023-11-13,ACTUAL,,,,2023-11-09,2023-11-13,ACTUAL,2018-10-30,ACTUAL,2018-10-30,2023-11,2023-11-30,2021-02-11,ACTUAL,2021-02-11,2021-02-11,ACTUAL,2021-02-11,,INTERVENTIONAL,,"For purposes of this single arm study, the determination of whether fosaprepitant or aprepitant was administered was entirely the choice of the ordering oncologist. Both agents are NK-1 receptor antagonists. Fosaprepitant is a phosphorylated analog of aprepitant and rapidly converts to aprepitant following IV injection.",Low Dose Aprepitant for Patients Receiving Carboplatin,Phase II Trial Testing the Antiemetic Efficacy of a Single-day Low Dose Aprepitant (or Fosaprepitant) Added to a 5-HT3 Receptor Antagonist Plus Dexamethasone in Patients Receiving Carboplatin,TERMINATED,,PHASE2,15.0,ACTUAL,Albert Einstein College of Medicine,,1.0,,Expired IRB approval on 2/11/21,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,OTHER,,,,,,,2021,0.0
NCT02308111,,2014-11-10,2022-12-20,,2023-02-13,2014-12-02,2014-12-04,ESTIMATED,2023-02-13,2023-03-09,ACTUAL,,,,2023-02-13,2023-03-09,ACTUAL,2014-12-26,ACTUAL,2014-12-26,2023-02,2023-02-28,2021-12-23,ACTUAL,2021-12-23,2021-12-23,ACTUAL,2021-12-23,,INTERVENTIONAL,COBALT,All randomized participants who received at least 1 dose of the study drug.,Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis,"A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary Cholangitis",TERMINATED,,PHASE4,334.0,ACTUAL,Intercept Pharmaceuticals,"The estimated effect of treatment from the ITT population was underpowered and potentially biased, resulting in difficulties in the interpretation of the tests of hypotheses for the primary and key secondary endpoints.",2.0,,The DMC made the recommendation to not pursue further enrollment given the lack of feasibility for this post-marketing study as designed.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,INDUSTRY,,,,,,,2021,0.0
NCT02528708,,2015-08-18,,,2021-03-10,2015-08-18,2015-08-19,ESTIMATED,,,,,,,2021-03-10,2021-03-15,ACTUAL,2021-01,ESTIMATED,2021-01-31,2021-03,2021-03-31,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,PERFECT PPH,,A Program to Evaluate Riastap® and FIBTEM® for the Early Control and Treatment of Postpartum Hemorrhage (PERFECT PPH),A Program to Evaluate Riastap® and FIBTEM® for the Early Control and Treatment of Postpartum Hemorrhage (PERFECT PPH),WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Yale University,,2.0,,The study never began.,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2021,0.0
NCT04898023,,2021-05-18,,,2024-05-15,2021-05-18,2021-05-24,ACTUAL,,,,,,,2024-05-15,2024-05-17,ACTUAL,2022-09-21,ACTUAL,2022-09-21,2024-05,2024-05-31,2023-12-20,ACTUAL,2023-12-20,2023-10-31,ACTUAL,2023-10-31,,INTERVENTIONAL,,,Zinc and Green Tea Extract for Community Respiratory Viral Infections,Evaluation of Combination Zinc and Green Tea Extract Supplementation on Reduction in Symptom Duration and Severity Associated With Community Respiratory Viral Infections: a Randomized Control Trial (ZiPhenol Study),TERMINATED,,PHASE2,17.0,ACTUAL,University of Missouri-Columbia,,2.0,,Loss of funding,f,,,,t,t,f,,,,,,,,,,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,OTHER,,,,,,,2023,0.0
NCT02841540,,2016-07-20,,,2024-02-13,2016-07-20,2016-07-22,ESTIMATED,,,,,,,2024-02-13,2024-02-14,ACTUAL,2016-10-06,ACTUAL,2016-10-06,2024-02,2024-02-29,2024-02-13,ACTUAL,2024-02-13,2024-02-13,ACTUAL,2024-02-13,,INTERVENTIONAL,Encore-MDS,,A Study of H3B-8800 (RVT-2001) in Participants With Lower Risk Myelodysplastic Syndromes,"An Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia",TERMINATED,,PHASE1,127.0,ACTUAL,Hemavant Sciences GmbH,,3.0,,The study was terminated after conducting an interim analysis of the available data where it became evident that the observed efficacy results were not in alignment with the initially set expectations.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,INDUSTRY,,,,,,,2024,0.0
NCT05125679,,2021-11-08,,,2023-08-22,2021-11-08,2021-11-18,ACTUAL,,,,,,,2023-08-22,2023-08-24,ACTUAL,2021-11-23,ACTUAL,2021-11-23,2023-08,2023-08-31,2023-07-28,ACTUAL,2023-07-28,2023-07-28,ACTUAL,2023-07-28,,INTERVENTIONAL,G-CARE,,Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Participants With Moderate to Severe Plaque Psoriasis,"A Phase 4, Interventional, Single-arm, Open-label Study Evaluating the Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Participants With Moderate to Severe Plaque Psoriasis",TERMINATED,,PHASE4,15.0,ACTUAL,Janssen-Cilag Ltd.,,1.0,,Terminated (A strategic decision was made not to further execute the study. This decision was not based on a safety concern),f,,,,f,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu",2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,INDUSTRY,,,,,,,2023,0.0
NCT02763579,,2016-05-04,2019-04-19,,2023-07-10,2016-05-04,2016-05-05,ESTIMATED,2019-05-21,2019-06-13,ACTUAL,,,,2023-07-10,2023-07-28,ACTUAL,2016-06-07,ACTUAL,2016-06-07,2023-07,2023-07-31,2022-07-07,ACTUAL,2022-07-07,2018-04-24,ACTUAL,2018-04-24,,INTERVENTIONAL,IMpower133,The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension. Separate analyses were performed for the Global population and the China population in the study.,A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC),"A Phase I/III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin Plus Etoposide With or Without Atezolizumab (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer",COMPLETED,,PHASE3,503.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,INDUSTRY,,,,,,,2022,1.0
NCT04583488,,2020-10-05,,,2024-08-06,2020-10-05,2020-10-12,ACTUAL,,,,,,,2024-08-06,2024-08-09,ACTUAL,2020-11-01,ACTUAL,2020-11-01,2024-08,2024-08-31,2024-08-06,ACTUAL,2024-08-06,2024-08-06,ACTUAL,2024-08-06,,INTERVENTIONAL,,,Intraperitoneal Docetaxel in Combination With mFOLFOX6 for Gastric Cancer Patients With Peritoneal Carcinomatosis,"A Phase I Study of Intraperitoneal Docetaxel in Combination With 5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6) for Gastric Cancer Patients With Peritoneal Carcinomatosis",TERMINATED,,PHASE1,2.0,ACTUAL,Johns Hopkins University,,1.0,,PI left institution,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,OTHER,,,,,,,2024,0.0
NCT02394535,,2015-03-16,,,2022-08-31,2015-03-16,2015-03-20,ESTIMATED,,,,,,,2022-08-31,2022-09-02,ACTUAL,2015-11-12,ACTUAL,2015-11-12,2022-08,2022-08-31,2022-08-31,ACTUAL,2022-08-31,2022-08-31,ACTUAL,2022-08-31,,INTERVENTIONAL,,,"Nab-Paclitaxel, Capecitabine, and Radiation Therapy Following Induction Chemotherapy in Treating Patients With Locally Advanced Pancreatic Cancer",Combining Abraxane With Capecitabine and Radiation Therapy for Consolidation of Treatment Following Induction Chemotherapy for Locally Advanced Pancreatic Cancer,COMPLETED,,PHASE1,25.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER,,,,,,,2022,1.0
NCT04607603,,2020-10-22,,,2022-10-03,2020-10-22,2020-10-29,ACTUAL,,,,,,,2022-10-03,2022-10-05,ACTUAL,2020-10-13,ACTUAL,2020-10-13,2022-10,2022-10-31,2022-03-29,ACTUAL,2022-03-29,2022-02-17,ACTUAL,2022-02-17,,INTERVENTIONAL,,,Efficacy of Cannabidiol in Knee Osteoarthritis,"Efficacy of Cannabidiol in Treatment of Pain Due to Symptomatic Osteoarthritis of the Knee: A Randomized, Double-blind, Placebo-controlled Clinical Trial",COMPLETED,,PHASE4,86.0,ACTUAL,Medical University of Vienna,,2.0,,,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,OTHER,,,,,,,2022,0.0
NCT03137082,,2017-04-24,2022-11-14,,2024-05-07,2017-04-27,2017-05-02,ACTUAL,2024-05-07,2024-06-05,ACTUAL,,,,2024-05-07,2024-06-05,ACTUAL,2017-07-12,ACTUAL,2017-07-12,2024-05,2024-05-31,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,,"32 women were enrolled in the study. N=17 were not eligible, N=15 were randomized to study medication",Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD),Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD),COMPLETED,,PHASE1/PHASE2,32.0,ACTUAL,Stony Brook University,Delay in study commencement and staff losses leading to small sample size.,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,OTHER,,,,,,,2021,1.0
NCT05019677,,2021-08-18,,,2022-03-22,2021-08-18,2021-08-25,ACTUAL,,,,,,,2022-03-22,2022-04-04,ACTUAL,2021-09-01,ESTIMATED,2021-09-01,2021-08,2021-08-31,2024-12-01,ESTIMATED,2024-12-01,2024-12-01,ESTIMATED,2024-12-01,,INTERVENTIONAL,,,GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Advanced BTC,A Study to Evaluate GP Chemotherapy in Combination With Tislelizumab(Anti-PD-1) and Ociperlimab(Anti-TIGIT) as First-line Treatment in Participants With Unresectable Advanced BTC,WITHDRAWN,,PHASE2,0.0,ACTUAL,Fudan University,,1.0,,Repeat registration,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,OTHER,,,,,,,2024,0.0
NCT04149899,,2019-10-30,2023-02-26,,2023-04-12,2019-11-01,2019-11-04,ACTUAL,2023-02-26,2023-03-24,ACTUAL,,,,2023-04-12,2023-05-03,ACTUAL,2019-11-14,ACTUAL,2019-11-14,2023-04,2023-04-30,2022-12-14,ACTUAL,2022-12-14,2021-01-31,ACTUAL,2021-01-31,,INTERVENTIONAL,,,Safety and IOP-Lowering Effects of WB007,A Phase 1/2a Assessment of WB007 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension,COMPLETED,,PHASE1/PHASE2,77.0,ACTUAL,"Whitecap Biosciences, LLC",,6.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,INDUSTRY,,,,,,,2022,1.0
NCT03100253,,2017-03-17,,,2022-09-16,2017-04-03,2017-04-04,ACTUAL,,,,,,,2022-09-16,2022-09-19,ACTUAL,2018-03-01,ACTUAL,2018-03-01,2022-09,2022-09-30,2021-12-31,ACTUAL,2021-12-31,2021-12-01,ACTUAL,2021-12-01,,INTERVENTIONAL,RAFTING,,Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation,"Open-label, Randomized Controlled Trial Comparing Tocilizumab to Anti-TNF Treatment and Discovery of Biomarkers for Treatment Selection in Rheumatoid Arthritis Patients With Inadequate Response to a First Anti-TNF",TERMINATED,,PHASE4,208.0,ACTUAL,Mario Negri Institute for Pharmacological Research,,2.0,,Slow recrutiment,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,OTHER,,,,,,,2021,0.0
NCT02557672,,2015-09-21,2022-05-16,,2022-05-16,2015-09-21,2015-09-23,ESTIMATED,2022-05-16,2022-06-07,ACTUAL,,,,2022-05-16,2022-06-07,ACTUAL,2016-08,ACTUAL,2016-08-31,2022-05,2022-05-31,2022-01,ACTUAL,2022-01-31,2021-06,ACTUAL,2021-06-30,,INTERVENTIONAL,,,PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding,"Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for Post-cardiopulmonary Bypass Coagulopathy and Bleeding, a Prospective Randomized Trial at Large US Medical Center.",COMPLETED,,PHASE4,106.0,ACTUAL,Mayo Clinic,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,OTHER,,,,,,,2022,1.0
NCT04678453,,2020-12-09,,,2024-02-28,2020-12-16,2020-12-22,ACTUAL,,,,,,,2024-02-28,2024-03-01,ACTUAL,2021-01-06,ACTUAL,2021-01-06,2023-03,2023-03-31,2024-01-31,ACTUAL,2024-01-31,2023-08-16,ACTUAL,2023-08-16,,INTERVENTIONAL,ASK-AD,,Safety of SNK01 in Subjects With Alzheimer's Disease (ASK-AD),"Single Center, Open Label, Phase 1 Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of SNK01 in Subjects With Alzheimer's Disease (AD)",TERMINATED,,PHASE1,10.0,ACTUAL,"NKGen Biotech, Inc.",,4.0,,The study was terminated after completing the dose escalation portion of the study. The expansion cohort was not initiated to conduct a global trial based on the approved US IND using a new manufacturing process.,f,,,,,t,f,,,t,,,,,,,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,INDUSTRY,,,,,,,2024,0.0
NCT03605667,,2018-07-23,2023-10-23,2021-10-26,2023-11-14,2018-07-27,2018-07-30,ACTUAL,2023-11-14,2023-12-06,ACTUAL,,2023-12-06,ACTUAL,2023-11-14,2023-12-06,ACTUAL,2018-07-31,ACTUAL,2018-07-31,2023-11,2023-11-30,2021-12-23,ACTUAL,2021-12-23,2020-12-15,ACTUAL,2020-12-15,,INTERVENTIONAL,T2 Protect AD,Treated population included enrolled and randomized participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).,Study of BHV-4157 in Alzheimer's Disease,A Phase 2 Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of BHV-4157 in Patients With Mild to Moderate Alzheimer's Disease,COMPLETED,,PHASE2,350.0,ACTUAL,"Biohaven Pharmaceuticals, Inc.",All participants in the OLE phase underwent a termination visit 2 weeks after the last dose of troriluzole.,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,INDUSTRY,,,,,,,2021,1.0
NCT03822962,,2019-01-28,,,2023-08-30,2019-01-28,2019-01-30,ACTUAL,,,,,,,2023-08-30,2023-09-06,ACTUAL,2020-11-07,ACTUAL,2020-11-07,2023-08,2023-08-31,2023-05-30,ACTUAL,2023-05-30,2023-05-30,ACTUAL,2023-05-30,,INTERVENTIONAL,,,Pain Management Following Sinus Surgery,Post-operative Pain Management Following Functional Endoscopic Sinus Surgery,TERMINATED,,EARLY_PHASE1,10.0,ACTUAL,University of Nebraska,,2.0,,Decrease in accrual during the COVID-19 pandemic and several sites withdrawing,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,OTHER,,,,,,,2023,0.0
NCT03472833,,2018-03-14,,,2022-01-31,2018-03-14,2018-03-21,ACTUAL,,,,,,,2022-01-31,2022-02-15,ACTUAL,2018-04-01,ACTUAL,2018-04-01,2022-01,2022-01-31,2021-04-20,ACTUAL,2021-04-20,2021-04-20,ACTUAL,2021-04-20,,INTERVENTIONAL,VITdCUT,,High-dose Vitamin D3 in Pancreas Cancer,"Influence of High Dose Vitamin D3 Intake on Outcome in Pancreatic Cancer Surgery: Prospective, Randomized, Open, Controlled Pilot Study",TERMINATED,,PHASE3,25.0,ACTUAL,Medical University of Graz,,2.0,,"slow recruitment, patients lost to follow-up due to Covid-19 pandemic.",f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,OTHER,,,,,,,2021,0.0
NCT04170959,,2019-05-24,,,2021-01-12,2019-11-18,2019-11-20,ACTUAL,,,,,,,2021-01-12,2021-01-15,ACTUAL,2018-07-30,ACTUAL,2018-07-30,2021-01,2021-01-31,2021-01-08,ACTUAL,2021-01-08,2021-01-08,ACTUAL,2021-01-08,,INTERVENTIONAL,RADFORMIN,,The Addition of Metformin to Definitive Radiotherapy in Patients With Stage III NSCLC,Randomized Phase II Trial of Definitive Radiotherapy With or Without metFORMin in Patients With Inoperable Stage III Non-small Cell Lung Cancer,TERMINATED,,PHASE2,3.0,ACTUAL,"University Hospital, Antwerp",,3.0,,Loss of external funding,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,OTHER,,,,,,,2021,0.0
NCT03712228,,2018-10-17,2022-10-13,,2022-10-13,2018-10-17,2018-10-19,ACTUAL,2022-10-13,2022-11-08,ACTUAL,,,,2022-10-13,2022-11-08,ACTUAL,2018-10-29,ACTUAL,2018-10-29,2022-10,2022-10-31,2021-10-15,ACTUAL,2021-10-15,2021-10-15,ACTUAL,2021-10-15,,INTERVENTIONAL,,"The Intent-to-Treat (ITT) population consisted of all subjects who provided informed consent, underwent any study screening procedure, and who were assigned to treatment in Treatment Period 1 or to treatment in Treatment Period 2, regardless of whether they received investigational product.",A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE),"A Multicenter, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy, Pharmacokinetics, and Safety of CSL312 in Subjects With Hereditary Angioedema",COMPLETED,,PHASE2,44.0,ACTUAL,CSL Behring,,5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,INDUSTRY,,,,,,,2021,1.0
NCT03008460,,2016-12-30,2021-01-28,,2021-03-01,2016-12-30,2017-01-02,ESTIMATED,2021-03-01,2021-03-02,ACTUAL,,,,2021-03-01,2021-03-02,ACTUAL,2017-10-15,ACTUAL,2017-10-15,2021-03,2021-03-31,2020-06-29,ACTUAL,2020-06-29,2020-02-24,ACTUAL,2020-02-24,,INTERVENTIONAL,EASYKID,The intention-to-treat (ITT) population included all randomised subjects who received even a partial dose of study drug.,"Efficacy, Safety and Tolerability of Eziclen®/Izinova® Versus Klean-prep® on Bowel Cleansing in Adolescents Undergoing Colonoscopy","Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (Eziclen/Izinova®) in Paediatric Subjects Undergoing Colonoscopy: a Phase III, Multicentre, Randomised, Comparative Study Versus Klean-Prep® (PEG-Electrolytes), Administered on the Day Before Colonoscopy, Investigator-blinded, Non-inferiority in Adolescents of 12 to 17 Years of Age (Inclusive) >40 kg",COMPLETED,,PHASE3,250.0,ACTUAL,Ipsen,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,INDUSTRY,,,,,,,2020,1.0
NCT04303845,,2020-03-09,2023-01-25,,2023-01-25,2020-03-10,2020-03-11,ACTUAL,2023-01-25,2023-02-17,ACTUAL,,,,2023-01-25,2023-02-17,ACTUAL,2021-08-04,ACTUAL,2021-08-04,2023-01,2023-01-31,2022-04-06,ACTUAL,2022-04-06,2022-04-06,ACTUAL,2022-04-06,,INTERVENTIONAL,,,Erenumab For Treatment of Hemicrania Continua,Erenumab For Treatment of Hemicrania Continua,TERMINATED,,PHASE2,2.0,ACTUAL,Mayo Clinic,Terminated study due to low enrollment,1.0,,difficulty with recruitment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 13:29:49.961578,2024-10-16 13:29:49.961578,OTHER,,,,,,,2022,0.0
NCT04809012,,2021-03-13,,,2022-03-09,2021-03-18,2021-03-22,ACTUAL,,,,,,,2022-03-09,2022-03-25,ACTUAL,2021-06,ESTIMATED,2021-06-30,2022-03,2022-03-31,2024-06,ESTIMATED,2024-06-30,2024-06,ESTIMATED,2024-06-30,,INTERVENTIONAL,,,Study of STI-3031 in Patients With Selected Relapsed or Refractory Solid Tumors,"An Open-label, Multicenter, Phase 2 Basket Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of STI-3031 in Patients With Selected Relapsed or Refractory Solid Tumors",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Sorrento Therapeutics, Inc.",,1.0,,Intended to be replaced with another Protocol,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,INDUSTRY,,,,,,,2024,0.0
NCT03861039,,2019-03-01,2022-01-21,,2022-01-21,2019-03-01,2019-03-04,ACTUAL,2022-01-21,2022-02-14,ACTUAL,,,,2022-01-21,2022-02-14,ACTUAL,2019-03-30,ACTUAL,2019-03-30,2022-01,2022-01-31,2021-02-16,ACTUAL,2021-02-16,2021-01-26,ACTUAL,2021-01-26,,INTERVENTIONAL,,All randomized participants.,A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes,"A Phase 3, Long-Term Safety Study of Tirzepatide in Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus (SURPASS J-combo)",COMPLETED,,PHASE3,443.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,f,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,INDUSTRY,,,,,,,2021,1.0
NCT04396366,,2020-05-18,,,2023-07-27,2020-05-18,2020-05-20,ACTUAL,,,,,,,2023-07-27,2023-08-01,ACTUAL,2021-02-02,ACTUAL,2021-02-02,2023-07,2023-07-31,2023-06-21,ACTUAL,2023-06-21,2023-06-15,ACTUAL,2023-06-15,,INTERVENTIONAL,,,"Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QBW251 in Subjects With Bronchiectasis","A Randomized, Subject- and Investigator-blinded, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QBW251 in Patients With Bronchiectasis",TERMINATED,,PHASE2,42.0,ACTUAL,Novartis,,2.0,,Strategic business decision,f,,,,,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,INDUSTRY,,,,,,,2023,0.0
NCT03986996,,2019-06-04,,,2022-05-29,2019-06-13,2019-06-14,ACTUAL,,,,,,,2022-05-29,2022-06-01,ACTUAL,2019-07-25,ACTUAL,2019-07-25,2022-05,2022-05-31,2022-05-30,ACTUAL,2022-05-30,2022-05-29,ACTUAL,2022-05-29,,INTERVENTIONAL,UC,,Antimicrobial Therapy for Ulcerative Colitis (UC),Antimicrobial Therapy for Ulcerative Colitis : Evaluation of Two Antibiotic Combinations for Refractory Ulcerative Colitis,TERMINATED,,PHASE2,20.0,ACTUAL,Wolfson Medical Center,,2.0,,There is no feasibility to conduct the study,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 03:05:49.652016,2024-10-15 03:05:49.652016,OTHER_GOV,,,,,,,2022,0.0
NCT05170828,,2021-11-12,,,2023-10-30,2021-12-08,2021-12-28,ACTUAL,,,,,,,2023-10-30,2023-11-01,ACTUAL,2022-09,ESTIMATED,2022-09-30,2023-10,2023-10-31,2024-11,ESTIMATED,2024-11-30,2024-03,ESTIMATED,2024-03-31,,INTERVENTIONAL,,,Cryopreserved MMUD BM With PTCy for Hematologic Malignancies,"PRESERVE: A Multi-Center Trial Using Banked, Cryopreserved HLA-Mismatched Unrelated Donor Bone Marrow and Post-Transplantation Cyclophosphamide in Allogeneic Transplantation for Patients With Hematologic Malignancies",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Ossium Health, Inc.",,3.0,,Change in Study Design,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,INDUSTRY,,,,,,,2024,0.0
NCT03139747,,2017-05-02,,,2021-10-07,2017-05-02,2017-05-04,ACTUAL,,,,,,,2021-10-07,2021-10-15,ACTUAL,2017-04-03,ACTUAL,2017-04-03,2021-10,2021-10-31,2022-05-30,ESTIMATED,2022-05-30,2022-05-30,ESTIMATED,2022-05-30,,INTERVENTIONAL,,,UPCC 36315 A Phase II Study Of Everolimus (RAD001) And Lenvatinib (E7080) In Patients With Metastatic Differentiated Thyroid Cancer Who Have Progressed on Lenvatinib Alone,UPCC 36315 A Phase II Study Of Everolimus (RAD001) And Lenvatinib (E7080) In Patients With Metastatic Differentiated Thyroid Cancer Who Have Progressed on Lenvatinib Alone,SUSPENDED,,PHASE2,5.0,ACTUAL,Thomas Jefferson University,,1.0,,lack of accrual reevaluating feasibility,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,OTHER,,,,,,,2022,0.0
NCT02971410,,2016-10-04,,,2018-06-29,2016-11-18,2016-11-23,ESTIMATED,,,,,,,2018-06-29,2018-07-02,ACTUAL,2017-04,ESTIMATED,2017-04-30,2018-06,2018-06-30,2021-11,ESTIMATED,2021-11-30,2021-11,ESTIMATED,2021-11-30,,INTERVENTIONAL,,,Simvastatin in Overcoming Chemotherapy Resistance in Patients With Relapsed or Refractory Multiple Myeloma,"Overcoming Chemotherapy Resistance in Refractory Multiple Myeloma With Simvastatin, A Pilot Study",WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Wake Forest University Health Sciences,,1.0,,PI no longer interested in pursuing study.,f,,,,,t,f,,,f,,,,,,,,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,OTHER,,,,,,,2021,0.0
NCT02038478,,2014-01-10,,,2021-07-22,2014-01-14,2014-01-16,ESTIMATED,,,,,,,2021-07-22,2021-07-29,ACTUAL,2014-01,,2014-01-31,2021-07,2021-07-31,2021-05,ACTUAL,2021-05-31,2021-01,ESTIMATED,2021-01-31,,INTERVENTIONAL,,,Allograft for Sickle Cell Disease and Thalassemia,Nonmyeloablative Allogeneic Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Severe Congenital Anemias Including Sickle Cell Disease and Thalassemia,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Texas Southwestern Medical Center,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,OTHER,,,,,,,2021,0.0
NCT02884206,,2016-08-25,2023-05-02,,2024-07-15,2016-08-25,2016-08-30,ESTIMATED,2024-07-15,2024-08-06,ACTUAL,,,,2024-07-15,2024-08-06,ACTUAL,2016-11-23,ACTUAL,2016-11-23,2024-07,2024-07-31,2022-05-16,ACTUAL,2022-05-16,2022-05-16,ACTUAL,2022-05-16,,INTERVENTIONAL,PERSPECTIVE,"Baseline Participants are based on the Randomized population, as primary and secondary analysis are based on the Randomized Set",Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction,"A Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction",COMPLETED,,PHASE3,592.0,ACTUAL,Novartis,,2.0,,,f,,,,t,,,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,INDUSTRY,,,,,,,2022,1.0
NCT02035137,,2014-01-07,2022-02-24,,2022-05-16,2014-01-10,2014-01-14,ESTIMATED,2022-05-16,2022-06-08,ACTUAL,,,,2022-05-16,2022-06-08,ACTUAL,2014-07,,2014-07-31,2022-05,2022-05-31,2021-02-26,ACTUAL,2021-02-26,2021-02-26,ACTUAL,2021-02-26,,INTERVENTIONAL,N2011-01,The 111 patients described as baseline participants removes the 3 ineligible patients as provided in the initial row of the participant flow module.,131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat,"NANT 2011- 01: Randomized Phase II Pick the Winner Study of 131I-MIBG, 131I-MIBG With Vincristine and Irinotecan, or 131I-MIBG With Vorinostat for Resistant/Relapsed Neuroblastoma",COMPLETED,,PHASE2,114.0,ACTUAL,New Approaches to Neuroblastoma Therapy Consortium,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,OTHER,,,,,,,2021,1.0
NCT03769181,,2018-11-29,2023-08-15,,2023-09-22,2018-12-05,2018-12-07,ACTUAL,2023-09-22,2023-10-17,ACTUAL,,,,2023-09-22,2023-10-17,ACTUAL,2018-12-11,ACTUAL,2018-12-11,2023-09,2023-09-30,2022-11-08,ACTUAL,2022-11-08,2022-11-08,ACTUAL,2022-11-08,,INTERVENTIONAL,,"Analysis was performed on all treated population which included all participants who signed the study informed consent and received at least 1 dose of the study treatment, either isatuximab or cemiplimab.",A Study of Isatuximab-based Therapy in Participants With Lymphoma,"A Phase 1/2 Open-label, Multi-center, Safety, Preliminary Efficacy and Pharmacokinetic (PK) Study of Isatuximab in Combination With Other Anti-cancer Therapies in Participants With Lymphoma",TERMINATED,,PHASE1/PHASE2,58.0,ACTUAL,Sanofi,"The efficacy results observed in Cohorts B and C did not fulfill the pre-planned interim analysis criteria allowing the study to move to Phase 2 Stage 2 in these cohorts. The efficacy results observed in Cohort A1 and A2 fulfilled the pre-planned interim analysis criteria in Stage 1 to move to Phase 2 Stage 2 in these cohorts. However, the study was stopped for all the cohorts as per Sponsor's decision.",4.0,,Study was stopped after interim analysis for all 4 cohorts with results either not fulfilling the pre-planned interim analysis criteria or fulfilling the criteria but as per sponsor decision. It was not due to any safety concern,f,,,,t,t,f,,,t,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,INDUSTRY,,,,,,,2022,0.0
NCT01869374,,2013-05-22,2020-02-27,,2020-08-18,2013-06-04,2013-06-05,ESTIMATED,2020-06-03,2020-06-19,ACTUAL,,,,2020-08-18,2020-09-03,ACTUAL,2012-08,ACTUAL,2012-08-31,2020-08,2020-08-31,2020-08,ACTUAL,2020-08-31,2017-07,ACTUAL,2017-07-31,,INTERVENTIONAL,MSTvsEST,,Study Comparing Magnetic Seizure Therapy (MST) to Electroconvulsive Therapy (ECT) for Depression in Older Adults,Improving Outcomes in Geriatric Depression: Magnetic Seizure Therapy,COMPLETED,,PHASE1/PHASE2,18.0,ACTUAL,New York State Psychiatric Institute,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-17 02:17:48.000579,2024-10-17 02:17:48.000579,OTHER,,,,,,,2020,0.0
NCT03335020,,2017-10-04,,,2020-05-27,2017-11-06,2017-11-07,ACTUAL,,,,,,,2020-05-27,2020-05-29,ACTUAL,2018-04-01,ACTUAL,2018-04-01,2020-05,2020-05-31,2020-12-31,ESTIMATED,2020-12-31,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,"Using Ultrasonography, Shear Wave Elastography, Strain Imaging, and 3-D Volume Ultrasonography on Cardiovascular Disease","Assessment of Contrast-enhanced Ultrasonography, Shear Wave Elastography, Strain Imaging, and 3-D Volume Ultrasonography on Arterial Wall Visualization and Stiffness in Patients With Fibromuscular Dysplasia...",WITHDRAWN,,PHASE1,0.0,ACTUAL,Mayo Clinic,,5.0,,Closed by Investigator,f,,,,f,t,t,,,f,,,,,,NO,,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,OTHER,,,,,,,2020,0.0
NCT04317781,,2020-03-19,2024-06-21,,2024-07-23,2020-03-19,2020-03-23,ACTUAL,2024-06-21,2024-07-16,ACTUAL,,,,2024-07-23,2024-07-31,ACTUAL,2020-03-27,ACTUAL,2020-03-27,2024-07,2024-07-31,2023-07-11,ACTUAL,2023-07-11,2023-07-11,ACTUAL,2023-07-11,,INTERVENTIONAL,,,Tagraxofusp in Treating Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm After Stem Cell Transplant,Tagraxofusp (SL-401) Therapy for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Patients Post-Autologous or Post-Allogeneic Hematopoietic Cell Transplantation,TERMINATED,,PHASE2,3.0,ACTUAL,M.D. Anderson Cancer Center,"The protocol was terminated early due to slow participant accrual and the sponsor not willing to provide the study drug.~Stemline is the funder, not the sponsor.",1.0,,The protocol was terminated early due to slow participant accrual and the sponsor not willing to provide the study drug.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,OTHER,,,,,,,2023,0.0
NCT01555281,,2012-03-08,,,2022-07-04,2012-03-13,2012-03-15,ESTIMATED,,,,,,,2022-07-04,2022-07-07,ACTUAL,2012-02-23,ACTUAL,2012-02-23,2022-07,2022-07-31,2022-06-08,ACTUAL,2022-06-08,2022-06-08,ACTUAL,2022-06-08,,INTERVENTIONAL,,,Nelfinavir and Lenalidomide/Dexamethasone in Progressive Multiple Myeloma,Nelfinavir and Lenalidomide/Dexamethasone in Patients With Progressive Multiple Myeloma That Have Failed Lenalidomide-containing Therapy - A Single Arm Phase I/II Trial,TERMINATED,,PHASE1/PHASE2,33.0,ACTUAL,Swiss Group for Clinical Cancer Research,,1.0,,"In connection with the restructuring of SAKK, older ongoing studies were analyzed to determine whether a continuation of the trial would still add value to the data analysis, or whether they do not and could therefore be prematurely terminated.",f,,,,t,,,,,,,,,,,NO,,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,OTHER,,,,,,,2022,0.0
NCT04634110,,2020-10-23,2022-08-15,,2022-09-27,2020-11-11,2020-11-18,ACTUAL,2022-09-27,2022-10-24,ACTUAL,,,,2022-09-27,2022-10-24,ACTUAL,2020-11-17,ACTUAL,2020-11-17,2022-09,2022-09-30,2022-04-14,ACTUAL,2022-04-14,2022-04-14,ACTUAL,2022-04-14,,INTERVENTIONAL,,,Brigatinib Before Brain Irradiation Trial (B3i Trial),Brigatinib Before Brain Irradiation Trial (B3i Trial): A Phase II Trial of Brigatinib Alone for Brain Metastases From ALK+ Lung Cancer,TERMINATED,,PHASE2,1.0,ACTUAL,"University of Colorado, Denver",1 subject enrolled then study terminated due to low accrual. No further analyses completed.,1.0,,Low accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,OTHER,,,,,,,2022,0.0
NCT04378010,,2020-05-04,2023-01-06,,2023-04-25,2020-05-04,2020-05-07,ACTUAL,2023-04-25,2023-05-19,ACTUAL,,,,2023-04-25,2023-05-19,ACTUAL,2020-01-27,ACTUAL,2020-01-27,2023-04,2023-04-30,2021-11-30,ACTUAL,2021-11-30,2021-10-04,ACTUAL,2021-10-04,,INTERVENTIONAL,,NOTE: In the EDP-305 2mg arm 1 participant was randomized but not treated.,"A Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASH","A Phase 2b Randomized, Double-Blind, Placebo-controlled, Multicenter Study Evaluating Safety and Efficacy of EDP-305 in Subjects With Liver Biopsy Proven Non-alcoholic Steatohepatitis (NASH) (ARGON-2)",TERMINATED,,PHASE2,98.0,ACTUAL,"Enanta Pharmaceuticals, Inc",No limitations reported for the study.,3.0,,"Enanta Pharmaceuticals, Inc. made the strategic decision to discontinue the ARGON-2 study to prioritize combination treatment approaches. This decision was not based on safety concerns.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,INDUSTRY,,,,,,,2021,0.0
NCT05362058,,2022-05-02,,,2024-07-30,2022-05-02,2022-05-05,ACTUAL,,,,,,,2024-07-30,2024-08-01,ACTUAL,2022-06-03,ACTUAL,2022-06-03,2024-07,2024-07-31,2024-04-10,ACTUAL,2024-04-10,2024-04-10,ACTUAL,2024-04-10,,INTERVENTIONAL,QWINT-2,,A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time,"A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Degludec in Insulin Naïve Adults With Type 2 Diabetes",COMPLETED,,PHASE3,928.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,INDUSTRY,,,,,,,2024,1.0
NCT04675983,,2020-12-03,,,2023-02-28,2020-12-15,2020-12-19,ACTUAL,,,,,,,2023-02-28,2023-03-02,ACTUAL,2021-03-10,ACTUAL,2021-03-10,2023-02,2023-02-28,2023-02-12,ACTUAL,2023-02-12,2023-02-12,ACTUAL,2023-02-12,,INTERVENTIONAL,,,A Study of Sintilimab Plus Ramucirumab as First-line Treatment for G/EGJ Adenocarcinoma (ORIENT-106),"A Randomized, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Sintilimab Combined With Ramucirumab as Compared to Chemotherapy for the First-line Treatment of Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (ORIENT-106)",TERMINATED,,PHASE3,36.0,ACTUAL,Innovent Biologics (Suzhou) Co. Ltd.,,2.0,,"Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators",f,,,,f,f,f,,,,,,,,,,,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,INDUSTRY,,,,,,,2023,0.0
NCT04316598,,2020-03-18,,,2020-07-29,2020-03-19,2020-03-20,ACTUAL,,,,,,,2020-07-29,2020-07-31,ACTUAL,2020-03-03,ACTUAL,2020-03-03,2020-07,2020-07-31,2020-07-09,ACTUAL,2020-07-09,2020-07-09,ACTUAL,2020-07-09,,INTERVENTIONAL,CEG,,Cannabis Effects on Electroencephalography,"Monocenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Assess the Pharmacodynamic Effects of Cannabis on Neural Oscillations in Healthy Recreational Cannabis Users",TERMINATED,,PHASE1,16.0,ACTUAL,Parc de Salut Mar,,2.0,,Terminated by the sponsor in the context of COVID-19 pandemia,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,OTHER,,,,,,,2020,0.0
NCT04558216,,2020-09-15,,,2022-02-10,2020-09-15,2020-09-22,ACTUAL,,,,,,,2022-02-10,2022-03-02,ACTUAL,2020-09-30,ACTUAL,2020-09-30,2022-02,2022-02-28,2021-02-19,ESTIMATED,2021-02-19,2021-02-07,ESTIMATED,2021-02-07,,INTERVENTIONAL,,,Evaluation of Effect of Rifampin on the Pharmacokinetics of Vonoprazan in Healthy Participants,"An Open-Label, Fixed-Sequence, Clinical Drug Interaction Study to Evaluate The Effect of a CYP3A-Inducer, Rifampin, on the Pharmacokinetics of Vonoprazan in Healthy Volunteers",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Phathom Pharmaceuticals, Inc.",,1.0,,Withdrawn due to unavailability of rifampin for clinical trial use,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,INDUSTRY,,,,,,,2021,0.0
NCT01417546,,2011-08-13,,,2021-10-15,2011-08-13,2011-08-16,ESTIMATED,,,,,,,2021-10-15,2021-10-18,ACTUAL,2011-12-12,ACTUAL,2011-12-12,2021-10,2021-10-31,2021-10-14,ACTUAL,2021-10-14,2021-06-02,ACTUAL,2021-06-02,,INTERVENTIONAL,,,NHS-IL12 for Solid Tumors,First In-Human Phase I Trial of NHS-IL12 in Patients With Metastatic Solid Tumors,COMPLETED,,PHASE1,72.0,ACTUAL,National Institutes of Health Clinical Center (CC),,3.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,NIH,,,,,,,2021,1.0
NCT05379179,,2022-04-15,2024-01-23,,2024-01-23,2022-05-10,2022-05-18,ACTUAL,2024-01-23,2024-02-14,ACTUAL,,,,2024-01-23,2024-02-14,ACTUAL,2022-06-20,ACTUAL,2022-06-20,2024-01,2024-01-31,2022-08-27,ACTUAL,2022-08-27,2022-08-27,ACTUAL,2022-08-27,,INTERVENTIONAL,,,Ketamine Pilot Study,Pilot Study: Ketamine for Acute Pain After Rattlesnake Envenomation,TERMINATED,,PHASE4,3.0,ACTUAL,University of Arizona,"Significant limitations were not reaching the target number of patients, extremely low enrollment resulted in termination.",2.0,,"After 20 months of active enrollment and a lack of qualified/interested subjects, the Investigator, Meghan Spyres, MD, decided to terminate recruitment before meeting the stated enrollment objectives.",f,,,,f,t,f,,,f,,,,,,NO,There is not a plan to make IPD available.,2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,OTHER,,,,,,,2022,0.0
NCT04140968,,2019-09-27,,,2022-03-15,2019-10-24,2019-10-28,ACTUAL,,,,,,,2022-03-15,2022-03-31,ACTUAL,2019-11-01,ACTUAL,2019-11-01,2022-03,2022-03-31,2021-05-27,ACTUAL,2021-05-27,2021-05-27,ACTUAL,2021-05-27,,INTERVENTIONAL,P4&REE,,Progesterone and Resting Energy Expenditure,Impact of Progesterone Substitution in Luteal Phase on Resting Energy Expenditure in Women During Menopausal Transition.,TERMINATED,,PHASE4,2.0,ACTUAL,"Insel Gruppe AG, University Hospital Bern",,1.0,,massive recruitment problems became apparent because of the strict inclusion criteria of our study.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,OTHER,,,,,,,2021,0.0
NCT05065463,,2021-09-23,,,2022-12-20,2021-09-23,2021-10-04,ACTUAL,,,,,,,2022-12-20,2022-12-22,ACTUAL,2022-08-10,ACTUAL,2022-08-10,2022-12,2022-12-31,2022-11-23,ACTUAL,2022-11-23,2022-11-23,ACTUAL,2022-11-23,,INTERVENTIONAL,,,"To Assess the Pharmacokinetics, Safety, and Tolerability of AZD8233 in Participants With Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD) and Healthy Participants.","A Single Dose, Non-randomised, Open-label, Parallel Group Study to Assess the Pharmacokinetics, PCSK9 Reduction, Safety, and Tolerability of AZD8233 in Participants With Severe Renal Impairment, End Stage Renal Disease and Healthy Participants as Controls",TERMINATED,,PHASE1,3.0,ACTUAL,AstraZeneca,,3.0,,A decision has been taken to discontinue the development of AZD8233 (PCSK9-ASO for sc administration) due to low likelihood of demonstrating a benefit significantly above the current standard of care for patients with high-risk hypercholesterolemia.,f,,,,f,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the requests portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,INDUSTRY,,,,,,,2022,0.0
NCT04527471,,2020-08-06,2022-08-26,,2022-08-26,2020-08-24,2020-08-26,ACTUAL,2022-08-26,2022-09-22,ACTUAL,,,,2022-08-26,2022-09-22,ACTUAL,2020-09-04,ACTUAL,2020-09-04,2020-08,2020-08-31,2021-05-01,ACTUAL,2021-05-01,2021-02-15,ACTUAL,2021-02-15,,INTERVENTIONAL,,,Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19,"A Single-center, Pilot, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ensifentrine in the Recovery of Hospitalized Patients With COVID-19",COMPLETED,,PHASE2,45.0,ACTUAL,Verona Pharma plc,This was an un-powered pilot study of ensifentrine pMDI in patients hospitalized for moderate COVID-19 infection.,2.0,,,f,,,,,t,f,,,,,,,,,NO,Verona Pharma will not be sharing individual deidentified participant data or other relevant study documents.,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,INDUSTRY,,,,,,,2021,1.0
NCT03874806,,2019-03-08,,,2019-07-11,2019-03-12,2019-03-14,ACTUAL,,,,,,,2019-07-11,2019-07-15,ACTUAL,2019-07-01,ESTIMATED,2019-07-01,2019-07,2019-07-31,2020-12-31,ESTIMATED,2020-12-31,2020-07-01,ESTIMATED,2020-07-01,,INTERVENTIONAL,,,Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block,Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block: a Comparison of Bolus Dosing and Continuous Infusion,WITHDRAWN,,PHASE4,0.0,ACTUAL,Virginia Commonwealth University,,2.0,,Did not receive funding,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,OTHER,,,,,,,2020,0.0
NCT04675177,,2020-12-14,,,2021-02-05,2020-12-14,2020-12-19,ACTUAL,,,,,,,2021-02-05,2021-02-10,ACTUAL,2019-09-01,ACTUAL,2019-09-01,2021-02,2021-02-28,2020-03-25,ACTUAL,2020-03-25,2020-02-01,ACTUAL,2020-02-01,,INTERVENTIONAL,,,Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease,Sclerotherapy With Polidocanol Foam Versus Hemorrhoidal Artery Ligation With Recto Anal Repair in the Treatment of Second and Third-grade Hemorrhoidal Disease: a Prospective Study,COMPLETED,,PHASE2/PHASE3,45.0,ACTUAL,Universidade do Porto,,2.0,,,f,,,,f,f,f,,,,,,Upon request,"Justified request (investigation, meta-analysis, medical education)",,YES,Study data can shared upon justified request,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,OTHER,,,,,,,2020,1.0
NCT05682222,,2022-07-22,,,2023-05-18,2023-01-11,2023-01-12,ACTUAL,,,,,,,2023-05-18,2023-05-19,ACTUAL,2022-06-27,ACTUAL,2022-06-27,2023-05,2023-05-31,2022-10-14,ACTUAL,2022-10-14,2022-10-14,ACTUAL,2022-10-14,,INTERVENTIONAL,,,Evaluation of the Immunopharmacology of EDP1815 and EDP2939,"A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Dose Platform Study Investigating the Immunopharmacology of EDP1815 and EDP2939.",COMPLETED,,PHASE1,38.0,ACTUAL,"Evelo Biosciences, Inc.",,4.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,INDUSTRY,,,,,,,2022,1.0
NCT05031481,,2021-08-26,,,2022-08-08,2021-08-26,2021-09-02,ACTUAL,,,,,,,2022-08-08,2022-08-10,ACTUAL,2022-07-01,ACTUAL,2022-07-01,2022-08,2022-08-31,2024-03,ESTIMATED,2024-03-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis.,"National, Multicenter, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis",WITHDRAWN,,PHASE2,0.0,ACTUAL,EMS,,4.0,,Sponsor decision,f,,,,t,f,f,,,,,,,,,,,2024-10-16 13:35:56.946772,2024-10-16 13:35:56.946772,INDUSTRY,,,,,,,2024,0.0
NCT05267574,,2022-02-24,2024-04-26,,2024-05-23,2022-03-03,2022-03-04,ACTUAL,2024-05-23,2024-05-28,ACTUAL,,,,2024-05-23,2024-05-28,ACTUAL,2022-02-01,ACTUAL,2022-02-01,2024-04,2024-04-30,2024-01-31,ACTUAL,2024-01-31,2023-12-14,ACTUAL,2023-12-14,,INTERVENTIONAL,,,"An Open Label, Long Term Safety Study of REN001 in Primary Mitochondrial Myopathy Patients (Stride Ahead)","An Open-label, Multi-centre Study to Evaluate the Long-term Safety and Tolerability of REN001 in Subjects With Primary Mitochondrial Myopathy (PMM)",TERMINATED,,PHASE2/PHASE3,155.0,ACTUAL,Reneo Pharma Ltd,,1.0,,Parent study failed to show therapeutic effect,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,INDUSTRY,,,,,,,2024,0.0
NCT02742090,,2016-04-11,2024-06-07,2022-06-07,2024-06-07,2016-04-13,2016-04-18,ESTIMATED,2024-06-07,2024-07-03,ACTUAL,2022-06-07,2022-06-08,ACTUAL,2024-06-07,2024-07-03,ACTUAL,2016-04-21,ACTUAL,2016-04-21,2024-06,2024-06-30,2021-06-10,ACTUAL,2021-06-10,2021-06-10,ACTUAL,2021-06-10,,INTERVENTIONAL,,The safety population included all participants who received at least one dose of study treatment.,Evaluate the Efficacy and Safety of TGR-1202 in Participants With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy,A Phase 2 Study to Assess the Safety and Efficacy of TGR-1202 (Umbralisib) in Patients With Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-Delta Inhibitor Therapy,TERMINATED,,PHASE2,51.0,ACTUAL,"TG Therapeutics, Inc.","Due to sponsor's business decision, the clinical trial was terminated by the sponsor prematurely.",1.0,,(Strategic/Business Decision),f,,,,f,,,,,,,,,,,YES,Data will be available upon study closure or as the study evolves,2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,INDUSTRY,,,,,,,2021,0.0
NCT04712006,,2021-01-14,,,2021-08-30,2021-01-14,2021-01-15,ACTUAL,,,,,,,2021-08-30,2021-09-01,ACTUAL,2021-05-30,ESTIMATED,2021-05-30,2021-08,2021-08-31,2021-10-30,ESTIMATED,2021-10-30,2021-08-27,ESTIMATED,2021-08-27,,INTERVENTIONAL,,,A Study of JNJ-64304500 Following Subcutaneous Injection in Healthy Chinese Adult Participants,"Phase 1, Open-label, Single Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of JNJ-64304500 Following Subcutaneous Injection in Healthy Chinese Adult Participants",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,Sponsor Decision.,f,,,,f,f,f,,,f,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu",2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,INDUSTRY,,,,,,,2021,0.0
NCT05048732,,2021-09-08,,,2024-05-29,2021-09-08,2021-09-17,ACTUAL,,,,,,,2024-05-29,2024-05-30,ACTUAL,2021-12-06,ACTUAL,2021-12-06,2024-05,2024-05-31,2024-02-10,ACTUAL,2024-02-10,2024-02-10,ACTUAL,2024-02-10,,INTERVENTIONAL,,,Imaging Apoptosis for Lymphoma Treatment Response,Imaging Apoptosis for Lymphoma Treatment Response,TERMINATED,,EARLY_PHASE1,12.0,ACTUAL,Washington University School of Medicine,,3.0,,Futility,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,OTHER,,,,,,,2024,0.0
NCT02585258,,2015-10-20,2021-12-20,,2023-07-15,2015-10-22,2015-10-23,ESTIMATED,2023-07-15,2023-07-18,ACTUAL,,,,2023-07-15,2023-07-18,ACTUAL,2016-06-30,ACTUAL,2016-06-30,2023-07,2023-07-31,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,Gloria,safety population: excludes 2 patients who did not start study medication,The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study,The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the Cost-effectiveness and Safety of Additional Low-dose Glucocorticoid in Treatment Strategies for Elderly Patients With Rheumatoid Arthritis,COMPLETED,,PHASE4,451.0,ACTUAL,"Amsterdam UMC, location VUmc","Initially slow recruitment, initiatives to enhance recruitment and retention hampered or prohibited by strict and varying ethical guidelines across countries.~The covid-19 pandemic compromised collection of important endpoint data. The pragmatic design caused confounding by treatment changes, most likely reducing the difference in benefit between the groups.~Post-hoc specification of adverse event frequencies done outside of statistical analysis plan.~See reference list (trial results).",2.0,,,f,,,,f,f,f,,,,,,expected active from 2022,scientific use,,YES,"(meta) data will be shared after signing a data sharing agreement, at reasonable cost",2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,OTHER,,,,,,,2020,1.0
NCT04388761,,2020-05-12,,,2023-10-16,2020-05-12,2020-05-14,ACTUAL,,,,,,,2023-10-16,2023-10-18,ACTUAL,2020-09,ESTIMATED,2020-09-30,2023-10,2023-10-31,2024-02,ESTIMATED,2024-02-29,2024-02,ESTIMATED,2024-02-29,,INTERVENTIONAL,,,Feasibility and Safety of Allogeneic Adipose Mesenchymal Stem Cells (aMSCs) Delivery Into Kidney Allografts Procured From Deceased Donors With High Kidney Donor Profile Index (KDPI),Feasibility and Safety of Allogeneic Adipose Mesenchymal Stem Cells (aMSCs) Delivery Into Kidney Allografts Procured From Deceased Donors With High Kidney Donor Profile Index (KDPI),WITHDRAWN,,PHASE1,0.0,ACTUAL,Mayo Clinic,,3.0,,Challenges in recruiting participants.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,OTHER,,,,,,,2024,0.0
NCT01333033,,2011-04-07,2020-05-26,,2023-04-10,2011-04-07,2011-04-11,ESTIMATED,2021-10-05,2021-11-03,ACTUAL,,,,2023-04-10,2023-04-13,ACTUAL,2011-07,ACTUAL,2011-07-31,2023-04,2023-04-30,2023-04-01,ACTUAL,2023-04-01,2015-11,ACTUAL,2015-11-30,,INTERVENTIONAL,,All participants who enrolled on this trial are included in this analysis.,PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy,Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer,COMPLETED,,PHASE2,257.0,ACTUAL,Alliance for Clinical Trials in Oncology,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,OTHER,,,,,,,2023,1.0
NCT04262375,,2020-02-05,,,2020-11-13,2020-02-07,2020-02-10,ACTUAL,,,,,,,2020-11-13,2020-11-17,ACTUAL,2021-01,ESTIMATED,2021-01-31,2020-11,2020-11-30,2024-01,ESTIMATED,2024-01-31,2024-01,ESTIMATED,2024-01-31,,INTERVENTIONAL,DOMINATION,,"A Phase 2 Study of Durvalumab (MEDI4736) and Oleclumab (MEDI9447) in Multi-Cancer Populations With Correlation to Clinical, Molecular and Immunologic Parameters With DNA MethylaTION","A Phase 2 Study of Durvalumab (MEDI4736) and Oleclumab (MEDI9447) in Multi-Cancer Populations With Correlation to Clinical, Molecular and Immunologic Parameters With DNA MethylaTION (DOMINATION)",WITHDRAWN,,PHASE2,0.0,ACTUAL,"University Health Network, Toronto",,1.0,,Overall clinical activity (ORR) for oleclumab + durvalumab is minimal across tumor types and does not support further evaluation of this doublet.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,OTHER,,,,,,,2024,0.0
NCT04614974,,2020-10-22,,,2024-08-02,2020-10-29,2020-11-04,ACTUAL,,,,,,,2024-08-02,2024-08-06,ACTUAL,2020-11-18,ACTUAL,2020-11-18,2024-08,2024-08-31,2024-05-17,ACTUAL,2024-05-17,2024-05-17,ACTUAL,2024-05-17,,INTERVENTIONAL,,,Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia,Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia,TERMINATED,,PHASE1/PHASE2,65.0,ACTUAL,University of Pittsburgh,,2.0,,Slow recruitment due to few eligible patients,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,OTHER,,,,,,,2024,0.0
NCT04865159,,2021-03-04,,,2023-09-19,2021-04-26,2021-04-29,ACTUAL,,,,,,,2023-09-19,2023-09-21,ACTUAL,2021-05-06,ACTUAL,2021-05-06,2023-04,2023-04-30,2023-05-02,ACTUAL,2023-05-02,2023-05-02,ACTUAL,2023-05-02,,INTERVENTIONAL,,,Cardiovascular Safety Study of Tipifarnib in Patients With Advanced Solid Malignancies,"A Phase I, Open-label Clinical Pharmacology Study to Evaluate the Effect of Tipifarnib on Cardiac Safety in Subjects With Advanced Solid Malignancies",TERMINATED,,PHASE1,6.0,ACTUAL,"Kura Oncology, Inc.",,1.0,,Study terminated due to recruitment challenges,t,,,,f,t,f,,,,,,,,,NO,,2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,INDUSTRY,,NCT04809233,AVAILABLE,,,,2023,0.0
NCT02100956,,2014-03-27,2023-08-08,,2023-09-08,2014-03-31,2014-04-01,ESTIMATED,2023-09-08,2023-10-03,ACTUAL,,,,2023-09-08,2023-10-03,ACTUAL,2014-06-19,ACTUAL,2014-06-19,2022-11,2022-11-30,2022-10-10,ACTUAL,2022-10-10,2022-10-10,ACTUAL,2022-10-10,,INTERVENTIONAL,,,Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain,Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain,TERMINATED,,PHASE2,8.0,ACTUAL,Wake Forest University Health Sciences,This study was terminated early due to slow recruitment and lack of funding.,2.0,,"Cessation of funding period prior to completion, due to slow recruitment during the pandemic",f,,,,t,t,,,,,,,,,,,,2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,OTHER,,,,,,,2022,0.0
NCT05757492,,2023-01-02,,,2024-08-06,2023-02-23,2023-03-07,ACTUAL,,,,,,,2024-08-06,2024-08-09,ACTUAL,2023-04-26,ACTUAL,2023-04-26,2024-08,2024-08-31,2024-07-31,ACTUAL,2024-07-31,2024-07-31,ACTUAL,2024-07-31,,INTERVENTIONAL,,,Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors,"A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CHS-006, as Monotherapy and in Combination With Toripalimab, in Participants With Advanced Solid Tumors",TERMINATED,,PHASE1/PHASE2,22.0,ACTUAL,"Coherus Biosciences, Inc.",,4.0,,The study was terminated for strategic reasons (not for safety concerns),f,,,,t,t,f,,,,,,,,,,,2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,INDUSTRY,,,,,,,2024,0.0
NCT05124691,,2021-11-16,,,2024-02-28,2021-11-17,2021-11-18,ACTUAL,,,,,,,2024-02-28,2024-03-01,ACTUAL,2022-01-20,ACTUAL,2022-01-20,2023-04,2023-04-30,2023-03-24,ACTUAL,2023-03-24,2023-03-21,ACTUAL,2023-03-21,,INTERVENTIONAL,ALIVE,,Evaluation of Effectiveness of ALBENDAZOLIVERMECTIN Coformulation vs ALBENDAZOLE for Treatment of Intestinal Worms,"An Adaptive Phase II/III SingleBlinded, Randomized, MultiCentre, ParallelGroup, Active Controlled, Superiority Study to Evaluate the Safety and Efficacy of a Single Day or 3day Single Dose of an ALBENDAZOLE IVERMECTIN Coformulation vs ALBENDAZOLE for the Treatment of SoilTransmitted Helminth Infections (Trichuris Trichiura, Hookworm, Strongyloides Stercoralis) in Paediatric and Young Adult Population",TERMINATED,,PHASE2/PHASE3,992.0,ACTUAL,Barcelona Institute for Global Health,,3.0,,Primary Endpoint met,f,,,,t,f,f,,,,,,Data is already available upon request to IDDO,All data sharing request received by IDDO will be addressed to the project consortium members who will approve/reject the data sharing based on the relevance of the proposal.,https://www.iddo.org/,YES,"All data from the ALIVE clinical trial (phase II and phase III) have been upload to the Infectious Diseases Data Observatory (IDDO). IDDO is a scientifically independent, multi-disciplinary coalition of the global infectious disease and emerging infections communities. Thus, data will be available upon request in a collaborative data repository for verification and re-use.",2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,OTHER,,,,,,,2023,0.0
NCT03834584,,2019-02-06,,,2020-08-21,2019-02-07,2019-02-08,ACTUAL,,,,,,,2020-08-21,2020-08-25,ACTUAL,2019-05-24,ACTUAL,2019-05-24,2020-08,2020-08-31,2020-06-17,ACTUAL,2020-06-17,2020-06-17,ACTUAL,2020-06-17,,INTERVENTIONAL,,,A Study of AG-636 in the Treatment of Subjects With Advanced Lymphoma,A Phase 1 Study of AG-636 in the Treatment of Subjects With Advanced Lymphoma,TERMINATED,,PHASE1,11.0,ACTUAL,"Agios Pharmaceuticals, Inc.",,1.0,,Terminated due to sponsor decision.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,INDUSTRY,,,,,,,2020,0.0
NCT03849365,,2019-01-24,,,2021-03-18,2019-02-19,2019-02-21,ACTUAL,,,,,,,2021-03-18,2021-03-23,ACTUAL,2019-01-21,ACTUAL,2019-01-21,2021-03,2021-03-31,2020-11-13,ACTUAL,2020-11-13,2020-11-13,ACTUAL,2020-11-13,,INTERVENTIONAL,,,"Study of Erectile Dysfunction, Urinary Incontinence and Related QoL After TOOKAD® VTP for Low Risk Prostate Cancer","Study of Erectile Dysfunction, Urinary Incontinence and Related Quality of Life After TOOKAD® Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Unilateral Low Risk Prostate Cancer",TERMINATED,,PHASE4,23.0,ACTUAL,Steba Biotech S.A.,,1.0,,Early end of enrolment with regards to difficulty met to enrol patients,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,OTHER,,,,,,,2020,0.0
NCT05216614,,2022-01-24,,,2022-02-23,2022-01-27,2022-01-31,ACTUAL,,,,,,,2022-02-23,2022-03-11,ACTUAL,2021-12-14,ACTUAL,2021-12-14,2022-02,2022-02-28,2022-02-22,ACTUAL,2022-02-22,2022-02-22,ACTUAL,2022-02-22,,INTERVENTIONAL,FluCOP,,Fluvoxamine to Augment Olfactory Recovery For Long COVID-19 Parosmia,Fluvoxamine to Augment Olfactory Recovery For Long COVID-19 Parosmia (FluCOP Trial),WITHDRAWN,,PHASE2,0.0,ACTUAL,Washington University School of Medicine,,2.0,,Unable to obtain investigational product,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,OTHER,,,,,,,2022,0.0
NCT04104646,,2019-09-24,2022-12-22,,2023-07-13,2019-09-24,2019-09-26,ACTUAL,2023-07-13,2023-08-03,ACTUAL,,,,2023-07-13,2023-08-03,ACTUAL,2020-12-18,ACTUAL,2020-12-18,2023-07,2023-07-31,2021-12-13,ACTUAL,2021-12-13,2021-12-13,ACTUAL,2021-12-13,,INTERVENTIONAL,NOWSHINE,,CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome,"A Phase II, Multicenter, Double Blind, Double Dummy, Randomized, 2 Arms Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome",TERMINATED,,PHASE2,7.0,ACTUAL,Chiesi Farmaceutici S.p.A.,"The study objectives could not be addressed because the study was terminated due to a low recruitment; for non-safety reasons.~Despite concerted efforts by the Sponsor to improve the enrolment rate (e.g., through communications with the Investigators, changing the training modalities to meet nurses' requests, and decreasing the sample size), the projected time frame to complete the study was longer than 5 years; this was considered unacceptable for the clinical development programme.",2.0,,Low recruitment rate,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,INDUSTRY,,,,,,,2021,0.0
NCT04947579,,2021-06-23,2024-02-21,,2024-04-03,2021-06-23,2021-07-01,ACTUAL,2024-04-03,2024-05-01,ACTUAL,,,,2024-04-03,2024-05-01,ACTUAL,2021-08-25,ACTUAL,2021-08-25,2024-04,2024-04-30,2023-02-21,ACTUAL,2023-02-21,2023-02-21,ACTUAL,2023-02-21,,INTERVENTIONAL,AS SpA axSpA,,A Study of CC-99677 in Participants With Active Ankylosing Spondylitis,"A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects With Active Ankylosing Spondylitis",TERMINATED,,PHASE2,167.0,ACTUAL,Celgene,,6.0,,The study has been terminated due to Non-Safety reasons because of lack of efficacy in the short-term acute phase.,f,,,,t,t,f,,,,,,See Plan Description,See Plan Description,https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,INDUSTRY,,,,,,,2023,0.0
NCT04820842,,2021-03-26,2023-11-03,2022-10-05,2023-12-22,2021-03-26,2021-03-29,ACTUAL,2023-12-22,2023-12-26,ACTUAL,,2023-12-26,ACTUAL,2023-12-22,2023-12-26,ACTUAL,2021-04-30,ACTUAL,2021-04-30,2023-12,2023-12-31,2021-11-03,ACTUAL,2021-11-03,2021-11-03,ACTUAL,2021-11-03,,INTERVENTIONAL,,Safety Analysis Set for the Active Drug Extension Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period.,A Study of TAK-994 in Adults With Narcolepsy,"A Dose-Blind Extension Study With Double-blind, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Safety and Explore the Pharmacokinetics and Pharmacodynamics of TAK-994 in Adults With Narcolepsy With Cataplexy (Narcolepsy Type 1)",TERMINATED,,PHASE2,26.0,ACTUAL,Takeda,,7.0,,"A safety signal has emerged in Phase 2 studies of TAK-994. As an immediate precautionary measure, Takeda has suspended dosing of patients and has decided to stop Phase 2 studies early.",f,,,,,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/ takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https:// clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,INDUSTRY,,,,,,,2021,0.0
NCT01895075,,2013-06-25,,,2018-08-09,2013-07-03,2013-07-10,ESTIMATED,,,,,,,2018-08-09,2018-08-13,ACTUAL,2019-01-01,ESTIMATED,2019-01-01,2018-08,2018-08-31,2020-09-01,ESTIMATED,2020-09-01,2020-07-01,ESTIMATED,2020-07-01,,INTERVENTIONAL,,,Inhaled Budesonide for Non-ventilated Infants at High Risk of Bronchopulmonary Dysplasia: the i-BUD Pilot Study,Evaluation of the Effectiveness of Inhaled Budesonide for Non-ventilated Infants at High Risk of Bronchopulmonary Dysplasia: the i-BUD Pilot Study,WITHDRAWN,,PHASE2,0.0,ACTUAL,Sunnybrook Health Sciences Centre,,2.0,,Insufficient funding,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,OTHER,,,,,,,2020,0.0
NCT03943342,,2019-05-07,,,2021-10-29,2019-05-07,2019-05-09,ACTUAL,,,,,,,2021-10-29,2021-11-05,ACTUAL,2020-03-11,ACTUAL,2020-03-11,2021-10,2021-10-31,2021-07-20,ACTUAL,2021-07-20,2021-07-20,ACTUAL,2021-07-20,,INTERVENTIONAL,,,Ibrutinib and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia After Ibrutinib Resistance,A Multicenter Study of Ibrutinib Resistance Development and Intervention With Venetoclax (Phase II),WITHDRAWN,,PHASE2,0.0,ACTUAL,Ohio State University Comprehensive Cancer Center,,1.0,,Study not feasible,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,OTHER,,,,,,,2021,0.0
NCT02867904,,2016-07-20,,,2021-05-02,2016-08-13,2016-08-16,ESTIMATED,,,,,,,2021-05-02,2021-05-06,ACTUAL,2016-03,ACTUAL,2016-03-31,2021-05,2021-05-31,2020-04,ACTUAL,2020-04-30,2020-04,ACTUAL,2020-04-30,,INTERVENTIONAL,,,Intra-Operative Corticosteroid Injection During Arthroscopic Shoulder Surgery,Efficacy of Intra-operative Subacromial Corticosteroid Injections on Surgical Outcomes After Arthroscopic Shoulder Surgery,TERMINATED,,PHASE4,12.0,ACTUAL,University of South Dakota,,2.0,,It was difficult to recruit patients to get the appropriate sample size.,f,,,,,,,,,,,,,,,,,2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,OTHER,,,,,,,2020,0.0
NCT03522584,,2018-04-30,2022-12-16,,2023-06-09,2018-04-30,2018-05-11,ACTUAL,2023-06-09,2023-06-12,ACTUAL,,,,2023-06-09,2023-06-12,ACTUAL,2018-05-17,ACTUAL,2018-05-17,2023-06,2023-06-30,2022-01-19,ACTUAL,2022-01-19,2021-12-16,ACTUAL,2021-12-16,,INTERVENTIONAL,,,"Durvalumab, Tremelimumab and Hypofractionated Radiation Therapy in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Durvalumab (MEDI4736), Tremelimumab and Palliative Hypofractionated Image Guided Radiation Therapy (HIGRT) in Patients With Recurrent/Metastatic Squamous Cell Carcinomas of the Head and Neck Previously Treated With Immune Checkpoint Inhibitors",TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,University of Washington,,1.0,,Terminated by the sponsor due to lack of efficacy in study treatment.,f,,,,t,t,t,,,,,,,,,NO,,2024-10-16 13:41:39.909895,2024-10-16 13:41:39.909895,OTHER,,,,,,,2022,0.0
NCT02349633,,2015-01-23,2021-05-13,,2021-05-13,2015-01-23,2015-01-29,ESTIMATED,2021-05-13,2021-06-10,ACTUAL,,,,2021-05-13,2021-06-10,ACTUAL,2015-05-14,ACTUAL,2015-05-14,2021-05,2021-05-31,2020-05-28,ACTUAL,2020-05-28,2020-05-28,ACTUAL,2020-05-28,,INTERVENTIONAL,,"Participants with advanced epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) were enrolled in this study. The safety analysis set included all enrolled patients who received at least 1 dose of study treatment. No enrollments occurred in Phase 1 Food Effect and Rifampin DDI sub-study, Phase 2 Cohort 2B or Phase 1b Cohort 3 prior to study termination.",Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M),PHASE 1/2 OPEN-LABEL STUDY OF PF-06747775 (EPIDERMAL GROWTH FACTOR RECEPTOR T790M INHIBITOR) IN PATIENTS WITH ADVANCED EPIDERMAL GROWTH FACTOR RECEPTOR MUTANT (DEL 19 OR L858R ± T790M) NON-SMALL CELL LUNG CANCER,TERMINATED,,PHASE1/PHASE2,65.0,ACTUAL,Pfizer,,4.0,,The study was ended for strategic reasons and changes in the external environment.~The safety profile and risk benefit ratio for PF-0674775 remained unchanged.,f,,,,f,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,INDUSTRY,,,,,,,2020,0.0
NCT04183790,,2019-11-28,,,2024-03-22,2019-11-28,2019-12-03,ACTUAL,,,,,,,2024-03-22,2024-03-25,ACTUAL,2020-02-17,ACTUAL,2020-02-17,2024-03,2024-03-31,2024-02-24,ACTUAL,2024-02-24,2024-02-24,ACTUAL,2024-02-24,,INTERVENTIONAL,,,Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older,"A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older",COMPLETED,,PHASE3,64.0,ACTUAL,Vertex Pharmaceuticals Incorporated,,1.0,,,t,,,,,t,f,,,,,,,,,NO,Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent research/clinical-trial-data-sharing,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,INDUSTRY,,NCT04702360,APPROVED_FOR_MARKETING,,,,2024,1.0
NCT04622111,,2020-11-06,,,2021-08-17,2020-11-06,2020-11-09,ACTUAL,,,,,,,2021-08-17,2021-08-18,ACTUAL,2020-05-27,ACTUAL,2020-05-27,2021-05,2021-05-31,2021-05-05,ACTUAL,2021-05-05,2021-04-01,ACTUAL,2021-04-01,,INTERVENTIONAL,,,Safety and Pharmacokinetics Study of CPL207280 Compound in Healthy Volunteers.,"One Centre, Single Ascending Dose and Double Blind Multiple Ascending Dose, Safety and Pharmacokinetics Phase I Study of CPL207280 Compound in Healthy Volunteers.",COMPLETED,,PHASE1,68.0,ACTUAL,Celon Pharma SA,,3.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,INDUSTRY,,,,,,,2021,1.0
NCT05832255,,2023-03-08,,,2024-05-06,2023-04-14,2023-04-27,ACTUAL,,,,,,,2024-05-06,2024-05-08,ACTUAL,2023-03-28,ACTUAL,2023-03-28,2024-05,2024-05-31,2024-05,ESTIMATED,2024-05-31,2024-05,ESTIMATED,2024-05-31,,INTERVENTIONAL,,,An Investigation of Psilocybin on Behavioural and Cognitive Symptoms of Adults With Fragile X Syndrome,An Open-Label Investigation of the Effects of Sub-Perceptual Repeat Dosing of Psilocybin on the Behavioural and Cognitive Symptoms of Fragile X Syndrome in Adult Patients,SUSPENDED,,PHASE2,10.0,ESTIMATED,Nova Mentis Life Science Corp,,1.0,,Indefinite hold due to protocol revisions relating to the exclusion criteria for concurrent medications.,f,,,,,f,f,,,f,,,,,,,,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,INDUSTRY,,,,,,,2024,0.0
NCT02277223,,2014-10-25,,,2021-09-25,2014-10-27,2014-10-28,ESTIMATED,,,,,,,2021-09-25,2021-10-01,ACTUAL,2020-03-01,ACTUAL,2020-03-01,2021-09,2021-09-30,2022-12-31,ESTIMATED,2022-12-31,2022-07-31,ESTIMATED,2022-07-31,,INTERVENTIONAL,,,Curcumin in Pediatric Ulcerative Colitis,Curcumin for Induction and Maintenance Therapy in Pediatric Ulcerative Colitis,WITHDRAWN,,PHASE3,0.0,ACTUAL,"Schneider Children's Medical Center, Israel",,2.0,,Difficulty to enroll patients,f,,,,t,f,f,,,,,,,,,,,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,OTHER,,,,,,,2022,0.0
NCT04340232,,2020-04-03,,,2021-03-03,2020-04-07,2020-04-09,ACTUAL,,,,,,,2021-03-03,2021-03-08,ACTUAL,2021-03,ESTIMATED,2021-03-31,2021-03,2021-03-31,2021-10,ESTIMATED,2021-10-31,2021-08,ESTIMATED,2021-08-31,,INTERVENTIONAL,,,Safety and Efficacy of Baricitinib for COVID-19,Safety and Efficacy of Baricitinib for COVID-19,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,"University of Colorado, Denver",,1.0,,Could not make FDA required changes,f,,,,,t,f,,,,,,Data will be made available upon publication in a peer-reviewed journal.,Data access requests will be reviewed by the sponsor-investigator and collaborators.,,YES,De-identified individual participant data will be made available for all primary outcome measures.,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,OTHER,,,,,,,2021,0.0
NCT03688230,,2018-09-24,,,2020-03-16,2018-09-26,2018-09-28,ACTUAL,,,,,,,2020-03-16,2020-03-18,ACTUAL,2019-04,ESTIMATED,2019-04-30,2020-03,2020-03-31,2021-08,ESTIMATED,2021-08-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,AMELION,,Study of Abituzumab in Combination With Cetuximab and FOLFIRI in Patients With Metastatic Colorectal Cancer.,"AMELION: A Randomized, Double Blinded, Phase 2, Efficacy and Safety Study of Abituzumab (EMD 525797) in Combination With Cetuximab and FOLFIRI Versus Placebo in Combination With Cetuximab and FOLFIRI in First-line RAS Wild-type, Left-sided, Metastatic Colorectal Cancer Patients With High ανβ6 Integrin Expression.",WITHDRAWN,,PHASE2,0.0,ACTUAL,"SFJ Pharmaceuticals, Inc.",,2.0,,Co-development decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,INDUSTRY,,,,,,,2021,0.0
NCT04488575,,2020-07-23,2022-07-22,,2022-11-22,2020-07-25,2020-07-28,ACTUAL,2022-11-22,2022-12-19,ACTUAL,,,,2022-11-22,2022-12-19,ACTUAL,2020-08-26,ACTUAL,2020-08-26,2022-07,2022-07-31,2021-05-19,ACTUAL,2021-05-19,2021-05-16,ACTUAL,2021-05-16,,INTERVENTIONAL,,,Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection,A Phase 2 Double-blind Placebo-controlled Study Investigating the Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With SARS-CoV-2 Infection,TERMINATED,,PHASE2,16.0,ACTUAL,"Evelo Biosciences, Inc.",,2.0,,Insufficient study defined patient population,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,INDUSTRY,,,,,,,2021,0.0
NCT04995978,,2021-08-02,,,2023-06-21,2021-08-02,2021-08-09,ACTUAL,,,,,,,2023-06-21,2023-06-23,ACTUAL,2021-12-01,ACTUAL,2021-12-01,2023-06,2023-06-30,2023-01-18,ACTUAL,2023-01-18,2023-01-18,ACTUAL,2023-01-18,,INTERVENTIONAL,,,Insulin Resistance and Androgen Deprivation Therapy,Insulin Resistance in Men With Prostate Cancer on Androgen Deprivation Therapy,WITHDRAWN,,PHASE2,0.0,ACTUAL,St. Louis University,,2.0,,No participants were recruited and the study was deemed not feasible,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,OTHER,,,,,,,2023,0.0
NCT04606563,,2020-10-27,,,2023-02-14,2020-10-27,2020-10-28,ACTUAL,,,,,,,2023-02-14,2023-02-16,ACTUAL,2020-10-09,ACTUAL,2020-10-09,2023-02,2023-02-28,2022-04-22,ACTUAL,2022-04-22,2022-04-22,ACTUAL,2022-04-22,,INTERVENTIONAL,ARBs CORONA II,,Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection?,Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection?,TERMINATED,,PHASE3,341.0,ACTUAL,University of British Columbia,,2.0,,DSMC recommendation due to futility,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,OTHER,,,,,,,2022,0.0
NCT02462421,,2015-04-24,2022-06-13,,2022-07-31,2015-06-01,2015-06-04,ESTIMATED,2022-07-07,2022-08-01,ACTUAL,,,,2022-07-31,2022-08-02,ACTUAL,2015-06-01,ACTUAL,2015-06-01,2022-07,2022-07-31,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,SGLT2iPGx,,Pharmacogenetics of SGLT2 Inhibitors,Pharmacogenetics of Sodium-dependent Glucose Transporter-2 (SGLT2) Inhibitors,TERMINATED,,PHASE4,30.0,ACTUAL,"University of Maryland, Baltimore","Small sample size: We had hoped to recruit more participants, but the need to collect two 24 hour urine samples turned out to be a major obstacle.~Small pilot study conducted in healthy volunteers rather than the target population for SGLT2 inhibitors.~Genetic studiy conducted in a Founder Population (Old Order Amish living in Lancaster County). Lancaster Amish chosen because of the availability of genotyping data and existence of infrastructure enabling genotype-directed call-back studies.",4.0,,Did not meet recruitment targets.,f,,,,f,,,,,,,,,,,NO,Individual participant data will not be shared in order to protect confidentiality of research subjects.,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,OTHER,,,,,,,2021,0.0
NCT04043845,,2019-07-31,,,2020-02-03,2019-08-01,2019-08-02,ACTUAL,,,,,,,2020-02-03,2020-02-05,ACTUAL,2020-02-03,ACTUAL,2020-02-03,2020-02,2020-02-29,2020-02-03,ACTUAL,2020-02-03,2020-02-03,ACTUAL,2020-02-03,,INTERVENTIONAL,,,ERK 1/2 Signaling in Ibrutinib Resistant B-cell Malignancies,A Phase 1 Study Targeting ERK 1/2 Signaling in Ibrutinib Resistant B-cell Malignancies,WITHDRAWN,,PHASE1,0.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,Business development reasons.,f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,OTHER,,,,,,,2020,0.0
NCT05101447,,2021-10-20,,,2023-08-28,2021-10-20,2021-11-01,ACTUAL,,,,,,,2023-08-28,2023-08-30,ACTUAL,2023-07,ESTIMATED,2023-07-31,2023-08,2023-08-31,2024-07,ESTIMATED,2024-07-31,2024-01,ESTIMATED,2024-01-31,,INTERVENTIONAL,PRUNE,,Pharmacokinetically-driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis,Pharmacokinetically-driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Children's Hospital Medical Center, Cincinnati",,2.0,,funding not secured,f,,,,t,t,f,,,t,,,,,,UNDECIDED,,2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,OTHER,,,,,,,2024,0.0
NCT02456532,,2015-05-06,2023-06-15,,2024-03-27,2015-05-27,2015-05-28,ESTIMATED,2024-03-27,2024-03-29,ACTUAL,,,,2024-03-27,2024-03-29,ACTUAL,2015-08-05,ACTUAL,2015-08-05,2023-07,2023-07-31,2022-02-22,ACTUAL,2022-02-22,2022-02-22,ACTUAL,2022-02-22,,INTERVENTIONAL,CIS2,,Safety and Efficacy of Chronic Hypnotic Use 2,Risks for Transition From Therapeutic Hypnotic Use to Abuse,COMPLETED,,PHASE4,41.0,ACTUAL,Henry Ford Health System,Difficulty reaching proposed enrollment target: 41 of projected 120 participants completed the study- in part due to COVID. Study is to be considered preliminary,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,OTHER,,,,,,,2022,1.0
NCT03827213,,2019-01-29,2023-01-04,,2023-02-12,2019-01-31,2019-02-01,ACTUAL,2023-02-12,2023-03-07,ACTUAL,,,,2023-02-12,2023-03-07,ACTUAL,2019-01-22,ACTUAL,2019-01-22,2023-02,2023-02-28,2021-06-01,ACTUAL,2021-06-01,2021-06-01,ACTUAL,2021-06-01,,INTERVENTIONAL,,,Exparel Interscalene vs Indwelling Catheter,Prospective Randomized Control Trial Evaluating Single Shot Exparel Versus Indwelling Interscalene Catheter for Total Shoulder Replacements- A Pilot Study,TERMINATED,,PHASE2,23.0,ACTUAL,Montefiore Medical Center,,2.0,,Ran out of medication,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,OTHER,,,,,,,2021,0.0
NCT01903486,,2013-07-16,,,2021-11-10,2013-07-16,2013-07-19,ESTIMATED,,,,,,,2021-11-10,2021-11-17,ACTUAL,2013-03,,2013-03-31,2021-11,2021-11-30,2020-12-28,ACTUAL,2020-12-28,2020-12-28,ACTUAL,2020-12-28,,INTERVENTIONAL,,,Assessing the Efficacy of Steroid Treatment of Achalasia,A Pilot Study Assessing the Efficacy of Steroids in the Treatment of Achalasia,WITHDRAWN,,PHASE4,0.0,ACTUAL,Mayo Clinic,,1.0,,Unable to recruit participants.,f,,,,f,t,f,,,,,,,,,,,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,OTHER,,,,,,,2020,0.0
NCT04120194,,2019-10-07,2022-08-22,,2023-04-11,2019-10-07,2019-10-09,ACTUAL,2023-04-11,2023-05-06,ACTUAL,,,,2023-04-11,2023-05-06,ACTUAL,2019-10-14,ACTUAL,2019-10-14,2023-04,2023-04-30,2020-12-13,ACTUAL,2020-12-13,2020-10-29,ACTUAL,2020-10-29,,INTERVENTIONAL,,"2654 participants were randomized at a 1:1 ratio into 1 of 2 vaccine groups. Both groups were stratified by site, age (65 to \< 75 and ≥ 75 years), and history of prior year receipt of the 2018-2019 influenza vaccine. The Safety Population was analyzed as actually treated (ie, based on the actual dose received).",Phase 3 Pivotal Trial of NanoFlu™ in Older Adults,"A Phase 3, Randomized, Observer-blinded, Active-controlled Trial to Evaluate Immunogenicity & Safety of a Recombinant Quadrivalent Nanoparticle Influenza Vaccine (Quad-NIV) With Matrix-M1™ Adjuvant Against Fluzone® Quadrivalent in Clinically Stable Adults ≥ 65 Years of Age",COMPLETED,,PHASE3,2654.0,ACTUAL,Novavax,,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,INDUSTRY,,,,,,,2020,1.0
NCT02792413,,2016-06-02,,,2023-08-08,2016-06-06,2016-06-07,ESTIMATED,,,,,,,2023-08-08,2023-08-09,ACTUAL,2018-11-19,ACTUAL,2018-11-19,2022-04,2022-04-30,2020-12-10,ACTUAL,2020-12-10,2020-12-10,ACTUAL,2020-12-10,,INTERVENTIONAL,HDENO,,Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease,Randomized Controlled Study Evaluating the Effect of a Biotherapy Treatment (Anti-RANKL Ligand Antibody: Denosumab) on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease,TERMINATED,,PHASE4,4.0,ACTUAL,"University Hospital, Montpellier",,2.0,,Modified study and new deposit in RECHMPL21_0451,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,OTHER,,,,,,,2020,0.0
NCT04583280,,2020-10-09,2023-03-16,,2024-02-28,2020-10-09,2020-10-12,ACTUAL,2023-03-16,2023-04-10,ACTUAL,,,,2024-02-28,2024-03-01,ACTUAL,2021-09-06,ACTUAL,2021-09-06,2024-02,2024-02-29,2022-03-18,ACTUAL,2022-03-18,2022-03-18,ACTUAL,2022-03-18,,INTERVENTIONAL,DAISY,,A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV),"A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir in Infants and Children (≥28 Days to ≤5 Years of Age) and Subsequently in Neonates (<28 Days of Age), Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)",TERMINATED,,PHASE3,28.0,ACTUAL,"Janssen Research & Development, LLC","As the study was terminated early, the Sponsor decided not to perform the complete analysis planned per protocol. Hence, data was collected and analyzed for safety, and selected PK and efficacy parameters only.",2.0,,Janssen made the strategic decision to discontinue the DAISY study. This decision is not based on any safety concerns.,f,,,,t,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,INDUSTRY,,,,,,,2022,0.0
NCT05234437,,2022-01-11,,,2023-04-16,2022-02-07,2022-02-10,ACTUAL,,,,,,,2023-04-16,2023-04-19,ACTUAL,2022-03-09,ACTUAL,2022-03-09,2022-10,2022-10-31,2022-07-18,ACTUAL,2022-07-18,2022-07-18,ACTUAL,2022-07-18,,INTERVENTIONAL,,,A Trial of Intratumoural Tigilanol Tiglate in Adult Participants With Stage IIIB to IV M1c Melanoma,"A Phase IIb, Multicentre, Open Label Study to Evaluate the Effectiveness, Safety and Tolerability of Intratumoural Tigilanol Tiglate in Adult Participants With Stage IIIB to IV M1c Melanoma",TERMINATED,,PHASE2,1.0,ACTUAL,QBiotics Group Limited,,1.0,,Insufficient Patient Recruitment Rates,f,,,,t,f,f,,,,,,,,,,,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,INDUSTRY,,,,,,,2022,0.0
NCT03384745,,2017-12-20,2021-04-01,,2021-08-02,2017-12-20,2017-12-27,ACTUAL,2021-07-09,2021-08-02,ACTUAL,,,,2021-08-02,2021-08-03,ACTUAL,2018-07-31,ACTUAL,2018-07-31,2021-08,2021-08-31,2020-03-26,ACTUAL,2020-03-26,2019-06-20,ACTUAL,2019-06-20,,INTERVENTIONAL,,,"A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis","A Phase 2b Randomized, Double-blind, Placebo Controlled, Multi-center 12-week Study With an Additional 40-week Follow-up Assessment of Efficacy, Safety and Tolerability of M1095 in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis",COMPLETED,,PHASE2,313.0,ACTUAL,Bond Avillion 2 Development LP,,6.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,INDUSTRY,,,,,,,2020,1.0
NCT02038634,,2013-09-25,2022-04-07,,2022-11-23,2014-01-15,2014-01-16,ESTIMATED,2022-11-23,2022-12-28,ACTUAL,,,,2022-11-23,2022-12-28,ACTUAL,2014-08-05,ACTUAL,2014-08-05,2022-11,2022-11-30,2021-03-15,ACTUAL,2021-03-15,2021-03-15,ACTUAL,2021-03-15,,INTERVENTIONAL,,,Ultrasound-guided Injection for DeQuervain's,Ultrasound-guided Injection for DeQuervain's,TERMINATED,,PHASE4,16.0,ACTUAL,Medical College of Wisconsin,Early termination due to lack of subject participation; statistical analysis not done due to small numbers. Outcome Measure # 2 was originally posted but was deleted as it was not included as part of the study design. No data was collected for that proposed outcome.,2.0,,not enough patient data,f,,,,t,,,,,,,,,,,NO,We have no plan to share the data we have collected with any other researchers.,2024-10-16 13:47:17.390155,2024-10-16 13:47:17.390155,OTHER,,,,,,,2021,0.0
NCT03248479,,2017-08-10,,,2023-09-29,2017-08-10,2017-08-14,ACTUAL,,,,,,,2023-09-29,2023-10-03,ACTUAL,2017-09-08,ACTUAL,2017-09-08,2023-09,2023-09-30,2023-09-05,ACTUAL,2023-09-05,2023-09-05,ACTUAL,2023-09-05,,INTERVENTIONAL,,,Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies,A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Patients With Hematological Malignancies,TERMINATED,,PHASE1,258.0,ACTUAL,Gilead Sciences,,8.0,,This study has been discontinued due to futility based on the results of a planned analysis of the ENHANCE trial.,t,,,,f,t,f,,,,,,,,,NO,,2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,INDUSTRY,,NCT05627466,NO_LONGER_AVAILABLE,,,,2023,0.0
NCT03602898,,2018-07-13,,,2021-06-25,2018-07-25,2018-07-27,ACTUAL,,,,,,,2021-06-25,2021-06-30,ACTUAL,2021-06-01,ESTIMATED,2021-06-01,2021-06,2021-06-30,2023-09-17,ESTIMATED,2023-09-17,2023-09-17,ESTIMATED,2023-09-17,,INTERVENTIONAL,,,Comparing ATG or Post-Transplant Cyclophosphamide to Calcineurin Inhibitor-Methotrexate as GVHD Prophylaxis After Myeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation,A Randomized Phase II Study to Compare ATG or Post-Transplant Cyclophosphamide to Calcineurin Inhibitor-Methotrexate as GVHD Prophylaxis After Myeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation,WITHDRAWN,,PHASE2,0.0,ACTUAL,Fred Hutchinson Cancer Center,,3.0,,Insufficient funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,OTHER,,,,,,,2023,0.0
NCT03922477,,2019-04-11,2021-10-14,,2021-12-03,2019-04-17,2019-04-22,ACTUAL,2021-12-03,2022-02-21,ACTUAL,,,,2021-12-03,2022-02-21,ACTUAL,2019-10-08,ACTUAL,2019-10-08,2021-12,2021-12-31,2020-11-03,ACTUAL,2020-11-03,2020-11-03,ACTUAL,2020-11-03,,INTERVENTIONAL,,,A Study Evaluating the Safety and Pharmacokinetics of Atezolizumab Administered in Combination With Hu5F9-G4 to Patients With Relapsed and/or Refractory Acute Myeloid Leukemia,"A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) Administered in Combination With Hu5F9-G4 to Patients With Relapsed and/or Refractory Acute Myeloid Leukemia",TERMINATED,,PHASE1,13.0,ACTUAL,Hoffmann-La Roche,,1.0,,The Sponsor decided to discontinue the development of atezolizumab in combination with magrolimab in the AML indication.,f,,,,,t,f,,,,,,,,,NO,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,INDUSTRY,,,,,,,2020,0.0
NCT02097121,,2014-03-24,2022-10-07,,2022-11-23,2014-03-24,2014-03-26,ESTIMATED,2022-11-23,2022-12-28,ACTUAL,,,,2022-11-23,2022-12-28,ACTUAL,2014-05-23,ACTUAL,2014-05-23,2022-11,2022-11-30,2022-02-10,ACTUAL,2022-02-10,2022-02-10,ACTUAL,2022-02-10,,INTERVENTIONAL,,The BOTOX-treated population (all participants enrolled into the study who received at least 1 BOTOX treatment) according to the dose received in the first treatment cycle.,OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17),BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age,TERMINATED,,PHASE3,56.0,ACTUAL,Allergan,,3.0,,,f,,,,f,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,INDUSTRY,,,,,,,2022,0.0
NCT03093454,,2017-03-10,2021-01-25,,2021-03-05,2017-03-22,2017-03-28,ACTUAL,2021-03-05,2021-04-01,ACTUAL,,,,2021-03-05,2021-04-01,ACTUAL,2017-10-27,ACTUAL,2017-10-27,2021-03,2021-03-31,2020-01-31,ACTUAL,2020-01-31,2020-01-31,ACTUAL,2020-01-31,,INTERVENTIONAL,,Participants who completed the study.,"Effects of Lavender Oil on Postoperative Pain, Sleep Quality and Mood","Effects of Lavender Oil on Postoperative Pain, Sleep Quality and Mood",COMPLETED,,PHASE3,58.0,ACTUAL,Duke University,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,OTHER,,,,,,,2020,1.0
NCT03111238,,2017-04-07,,,2021-05-05,2017-04-11,2017-04-12,ACTUAL,,,,,,,2021-05-05,2021-05-07,ACTUAL,2017-04-05,ACTUAL,2017-04-05,2021-05,2021-05-31,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,,,The Efficacy and Safety of REX-001 to Treat Ischemic Rest Pain in Subjects With CLI Rutherford Category 4 and DM,"The Efficacy and Safety of Intra-arterial Administration of REX-001 to Treat Ischemic Rest Pain in Subjects With Critical Limb Ischemia (CLI) Rutherford Category 4 and Diabetes Mellitus (DM): a Pivotal, Placebo-controlled, Double-blind, Parallel-group, Adaptive Trial",TERMINATED,,PHASE3,3.0,ACTUAL,Ixaka Ltd,,2.0,,Stopped due to inactivity,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,INDUSTRY,,,,,,,2021,0.0
NCT05323136,,2022-03-26,,,2023-01-23,2022-04-04,2022-04-12,ACTUAL,,,,,,,2023-01-23,2023-01-26,ACTUAL,2022-04-15,ACTUAL,2022-04-15,2023-01,2023-01-31,2022-06-29,ACTUAL,2022-06-29,2022-06-29,ACTUAL,2022-06-29,,INTERVENTIONAL,,,Evaluate the Effects of Renal Impairment on the Pharmacokinetics and Pharmacodynamics,"A Phase 1, Open-Label, Sequential, Adaptive, Single Dose Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics and Pharmacodynamics of MT1002 for Injection",TERMINATED,,PHASE1,2.0,ACTUAL,Shaanxi Micot Technology Limited Company,,2.0,,Strategic decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,INDUSTRY,,,,,,,2022,0.0
NCT03297359,,2017-09-26,,,2024-01-22,2017-09-26,2017-09-29,ACTUAL,,,,,,,2024-01-22,2024-01-23,ACTUAL,2018-03-21,ACTUAL,2018-03-21,2024-01,2024-01-31,2023-11-30,ACTUAL,2023-11-30,2023-11-30,ACTUAL,2023-11-30,,INTERVENTIONAL,WAVe,,WAVe Study - Weight Adjusted Dalteparin for Patients Over 90 kg With Acute Cancer Associated Venous Thromboembolism,A Multicentre Prospective Cohort Study Assessing the Use of Weight-Adjusted Low-Molecular-Weight-Heparin in Patients Over 90 kg With Acute Cancer-Associated Venous Thromboembolism,TERMINATED,,PHASE2,92.0,ACTUAL,Ottawa Hospital Research Institute,,1.0,,Low recruitment,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,OTHER,,,,,,,2023,0.0
NCT03509298,,2018-04-17,,,2020-10-13,2018-04-17,2018-04-26,ACTUAL,,,,,,,2020-10-13,2020-10-19,ACTUAL,2018-04-12,ACTUAL,2018-04-12,2020-05,2020-05-31,2020-07-12,ACTUAL,2020-07-12,2020-05-20,ACTUAL,2020-05-20,,INTERVENTIONAL,,,Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Pancreatic Cancer,Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Pancreatic Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Fuda Cancer Hospital, Guangzhou",,3.0,,No participants enrolled,f,,,,t,f,f,,,,,,,,,,,2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,OTHER,,,,,,,2020,0.0
NCT05117008,,2021-11-02,,,2024-08-07,2021-11-02,2021-11-11,ACTUAL,,,,,,,2024-08-07,2024-08-09,ACTUAL,2022-07-19,ACTUAL,2022-07-19,2024-08,2024-08-31,2024-01-15,ACTUAL,2024-01-15,2024-01-15,ACTUAL,2024-01-15,,INTERVENTIONAL,EMBRACE,,Maintenance Belantamab Mafodotin (Blenrep®) After B-cell Maturation Antigen-Directed Chimeric Antigen Receptor T-cell Therapy in Patients With Relapsed and/or Refractory Multiple Myeloma,A Multicenter Phase II Study of Maintenance Belantamab Mafodotin (Blenrep®) After BCMA-Directed Chimeric Antigen Receptor T-cell Therapy in Patients With Relapsed and/or Refractory Multiple Myeloma,TERMINATED,,PHASE2,1.0,ACTUAL,Medical College of Wisconsin,,1.0,,Low enrollment.,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,OTHER,,,,,,,2024,0.0
NCT02366195,,2014-11-11,2018-06-21,,2021-11-26,2015-02-12,2015-02-19,ESTIMATED,2018-06-21,2018-07-18,ACTUAL,,,,2021-11-26,2021-11-30,ACTUAL,2015-04-07,ACTUAL,2015-04-07,2021-11,2021-11-30,2020-12-25,ACTUAL,2020-12-25,2017-06-26,ACTUAL,2017-06-26,,INTERVENTIONAL,TVEC-325,Participants who received at least 1 dose of talimogene laherparepvec.,Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma,"A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated With Talimogene Laherparepvec",COMPLETED,,PHASE2,112.0,ACTUAL,Amgen,,1.0,,,f,,,,f,,,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,INDUSTRY,,,,,,,2020,1.0
NCT01536717,,2012-02-16,,,2019-05-03,2012-02-21,2012-02-22,ESTIMATED,,,,,,,2019-05-03,2019-05-07,ACTUAL,2012-03,,2012-03-31,2019-05,2019-05-31,2022-12,ESTIMATED,2022-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Comparison of the Local Anaesthetics Articaine and Bupivacaine in Treatment of Acute Sternum Pain After Heart Surgery,Comparison of Periosteal and Subcutaneous Infusions of Articaine and Bupivacaine in Treatment of Acute Pain After Sternotomy,SUSPENDED,,PHASE4,36.0,ACTUAL,Helsinki University Central Hospital,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,OTHER,,,,,,,2022,0.0
NCT01908426,,2013-07-23,2018-10-16,,2021-04-08,2013-07-24,2013-07-25,ESTIMATED,2019-02-27,2019-03-01,ACTUAL,,,,2021-04-08,2021-05-06,ACTUAL,2013-09-26,,2013-09-26,2021-04,2021-04-30,2021-01-12,ACTUAL,2021-01-12,2017-10-16,ACTUAL,2017-10-16,,INTERVENTIONAL,CELESTIAL,,Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib,"A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib",COMPLETED,,PHASE3,707.0,ACTUAL,Exelixis,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,INDUSTRY,,,,,,,2021,1.0
NCT04232397,,2020-01-15,,,2021-03-22,2020-01-15,2020-01-18,ACTUAL,,,,,,,2021-03-22,2021-03-24,ACTUAL,2020-04-10,ACTUAL,2020-04-10,2021-03,2021-03-31,2021-03-01,ACTUAL,2021-03-01,2020-09-15,ACTUAL,2020-09-15,,INTERVENTIONAL,,,Anlotinib Treatment in Steroid Depenent/Refractory cGVHD,A Phase 2 Study of Anlotinib in Subjects With Steroid Depenent/Refractory Chronic Graft Versus Host Disease(cGVHD),TERMINATED,,PHASE2,5.0,ACTUAL,"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",,1.0,,the efficency is not good enough to enroll more patients,f,,,,t,f,f,,,f,,,,,,,,2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,OTHER,,,,,,,2021,0.0
NCT02028806,,2014-01-01,,,2023-02-14,2014-01-04,2014-01-07,ESTIMATED,,,,,,,2023-02-14,2023-02-16,ACTUAL,2013-02,ACTUAL,2013-02-28,2023-02,2023-02-28,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,,,mFOLFIRINOX as First-Line Chemotherapy in Treating Chinese Patients With Metastatic Pancreatic Cancer,Phase Ⅱ Trial to Investigate the Efficacy and Safety of mFOLFIRINOX in Patients With Metastatic Pancreatic Cancer in China,COMPLETED,,PHASE2,40.0,ACTUAL,Sun Yat-sen University,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,OTHER,,,,,,,2020,1.0
NCT02872116,,2016-08-16,2022-05-18,2021-05-26,2024-07-01,2016-08-18,2016-08-19,ESTIMATED,2022-06-23,2022-06-28,ACTUAL,2021-05-27,2021-06-01,ACTUAL,2024-07-01,2024-07-12,ACTUAL,2016-10-12,ACTUAL,2016-10-12,2024-07,2024-07-31,2024-06-06,ACTUAL,2024-06-06,2020-05-27,ACTUAL,2020-05-27,,INTERVENTIONAL,CheckMate649,,Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer,"A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer",COMPLETED,,PHASE3,2031.0,ACTUAL,Bristol-Myers Squibb,,5.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,INDUSTRY,,,,,,,2024,1.0
NCT03392571,,2017-12-06,,,2019-05-03,2018-01-02,2018-01-08,ACTUAL,,,,,,,2019-05-03,2019-05-07,ACTUAL,2018-08-15,ESTIMATED,2018-08-15,2019-05,2019-05-31,2020-12-30,ESTIMATED,2020-12-30,2020-12-30,ESTIMATED,2020-12-30,,INTERVENTIONAL,,,Phase II Study of NGC-Triple Regimen in Potentially Resectable Pancreatic Cancer Patients,"Phase II Multi-Center Study of Nab-paclitaxel, Gemcitabine and Cisplatin (NGC-Triple Regimen as Preoperative Therapy in Patients With Potentially Resectable and Borderline Resectable Pancreatic Cancer",WITHDRAWN,,PHASE2,0.0,ACTUAL,Pancreatic Cancer Research Team,,1.0,,Study was stopped due to lack of funding,f,,,,f,f,f,,,f,,,,,,,,2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,OTHER,,,,,,,2020,0.0
NCT04446637,,2020-06-23,,,2021-09-03,2020-06-23,2020-06-25,ACTUAL,,,,,,,2021-09-03,2021-09-13,ACTUAL,2021-09-03,ESTIMATED,2021-09-03,2021-09,2021-09-30,2022-09-03,ESTIMATED,2022-09-03,2022-09-03,ESTIMATED,2022-09-03,,INTERVENTIONAL,,,Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD,Comparison of Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination Delivered Via pMDI and Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol in Patients With Stable Moderate-Severe-Very Severe Chronic Obstructive Pulmonary Disease (COPD).,WITHDRAWN,,PHASE3,0.0,ACTUAL,Neutec Ar-Ge San ve Tic A.Ş,,2.0,,administrative decision,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 03:12:16.296022,2024-10-15 03:12:16.296022,INDUSTRY,,,,,,,2022,0.0
NCT04139330,,2019-10-18,,,2021-06-29,2019-10-23,2019-10-25,ACTUAL,,,,,,,2021-06-29,2021-07-01,ACTUAL,2019-11-21,ACTUAL,2019-11-21,2020-06,2020-06-30,2021-02-28,ACTUAL,2021-02-28,2021-02-28,ACTUAL,2021-02-28,,INTERVENTIONAL,,,NPC-06 to Acute Pain in Herpes Zoster,"A Multicenter, Double-blind, Randomized, Placebo-controlled Parallel Group Trial to Investigate the Proof of Concept of NPC-06 to Acute Pain in Herpes Zoster",TERMINATED,,PHASE2,16.0,ACTUAL,Nobelpharma,,3.0,,Low recruitment,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,INDUSTRY,,,,,,,2021,0.0
NCT04828161,,2021-03-24,2022-11-14,2022-07-28,2022-12-21,2021-03-30,2021-04-01,ACTUAL,2022-12-21,2023-01-18,ACTUAL,2022-12-21,2023-01-18,ACTUAL,2022-12-21,2023-01-18,ACTUAL,2021-05-10,ACTUAL,2021-05-10,2022-12,2022-12-31,2022-01-27,ACTUAL,2022-01-27,2021-11-18,ACTUAL,2021-11-18,,INTERVENTIONAL,EMPATHY,Full analysis set (FAS) included all participants in the randomized set for whom IV infusion of study treatment was initiated during the treatment period.,"A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19","A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19 - The EMPATHY Trial",TERMINATED,,PHASE2/PHASE3,407.0,ACTUAL,Novartis,"Part B was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate. 2 patients randomized to ensovibep 225 mg didn't receive treatment they were randomized to: 1 patient received no active drug as infusion was not prepared correctly; 1 patient received lower dose (\<75 mg) as infusion was interrupted. For Safety set, these 2 were reported in placebo and ensovibep 75 mg arms, respectively.",6.0,,"Phase 2 completed as planned. Due to the evolving landscape of treatments for COVID-19, the placebo-controlled Phase 3 design will not proceed. No patients were actively participating at the time of termination.",f,,,,t,t,f,,,,,,,,https://www.clinicalstudydatarequest.com/,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.",2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,INDUSTRY,,,,,,,2022,0.0
NCT04954014,,2021-07-06,,,2021-08-31,2021-07-07,2021-07-08,ACTUAL,,,,,,,2021-08-31,2021-09-05,ACTUAL,2020-09-01,ACTUAL,2020-09-01,2021-08,2021-08-31,2021-08-31,ACTUAL,2021-08-31,2021-08-31,ACTUAL,2021-08-31,,INTERVENTIONAL,BEVACOR,,Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients,Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients,TERMINATED,,PHASE2,21.0,ACTUAL,Maimónides Biomedical Research Institute of Córdoba,,2.0,,"Lack of financing, lack of COVID19 patients in the ICU.",f,,,,f,f,f,,,,,,When study is published.,Send request to access.,,YES,,2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,OTHER,,,,,,,2021,0.0
NCT04258423,,2020-01-31,2021-08-17,,2023-04-28,2020-02-04,2020-02-06,ACTUAL,2023-04-28,2023-05-24,ACTUAL,,,,2023-04-28,2023-05-24,ACTUAL,2019-12-19,ACTUAL,2019-12-19,2023-04,2023-04-30,2020-06-27,ACTUAL,2020-06-27,2020-06-27,ACTUAL,2020-06-27,,INTERVENTIONAL,,,Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function,Preservation of Renal Function After Liver Transplant for Patients With Pre-existing Chronic Kidney Disease or Peri-operative Acute Kidney Injury Using Everolimus Plus Mycophenolate Mofetil Immunosuppression Regimen,TERMINATED,,PHASE3,4.0,ACTUAL,Indiana University,,2.0,,Study was larger than expected and became a burden to faculty and staff resources.,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2020,0.0
NCT03691909,,2018-09-27,2021-08-19,,2022-03-22,2018-09-28,2018-10-02,ACTUAL,2022-02-24,2022-03-22,ACTUAL,,,,2022-03-22,2022-03-31,ACTUAL,2018-09-25,ACTUAL,2018-09-25,2022-02,2022-02-28,2020-09-28,ACTUAL,2020-09-28,2020-08-17,ACTUAL,2020-08-17,,INTERVENTIONAL,HB-adMSCs,,Phase 1/2a Clinical Trial to Assess the Safety of HB-adMSCs for the Treatment of Rheumatoid Arthritis,A Phase 1/2a Clinical Trial to Assess Safety of a Single IV Infusion of Autologous Adipose-derived Mesenchymal Stem Cells in Adults With Active Rheumatoid Arthritis,COMPLETED,,PHASE1/PHASE2,15.0,ACTUAL,Hope Biosciences,,1.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,INDUSTRY,,,,,,,2020,1.0
NCT04077021,,2019-08-20,,,2023-05-10,2019-09-03,2019-09-04,ACTUAL,,,,,,,2023-05-10,2023-05-12,ACTUAL,2020-07-17,ACTUAL,2020-07-17,2023-05,2023-05-31,2022-10-21,ACTUAL,2022-10-21,2022-10-21,ACTUAL,2022-10-21,,INTERVENTIONAL,,,First-in-human Study of CCW702 in Patients With Metastatic Castration Resistant Prostate Cancer,"A Phase 1, Open-label Study in Two Parts, Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of CCW702 in Patients With Metastatic, Castration Resistant Prostate Adenocarcinoma",TERMINATED,,PHASE1,22.0,ACTUAL,"Calibr, a division of Scripps Research",,3.0,,Business decision,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2022,0.0
NCT05266456,,2022-02-23,2024-01-07,,2024-03-25,2022-02-23,2022-03-04,ACTUAL,2024-03-25,2024-04-18,ACTUAL,,,,2024-03-25,2024-04-18,ACTUAL,2022-02-22,ACTUAL,2022-02-22,2024-03,2024-03-31,2023-01-10,ACTUAL,2023-01-10,2023-01-10,ACTUAL,2023-01-10,,INTERVENTIONAL,,Baseline demographics include all randomized subjects from Phase 1 and Phase 2 by age group. The prespecified immunogenicity analysis and Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values included only subjects 50-64 years old.,"Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults","A Phase 1/2, Randomized, Observer-Blind, Dose-Finding, Controlled, Parallel-Group, Two-Stage Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Adults Aged 18 to 64 Years",COMPLETED,,PHASE1/PHASE2,835.0,ACTUAL,"Vaxcyte, Inc.","Some limitations of this clinical study include the lack of a group, such as 3·3 µg or 4·4 µg, for all serotypes, aimed at understanding whether the dose response of polysaccharide can overcome carrier suppression. The relatively low ethnic diversity of participants is also a limitation, which will be addressed in larger phase 3 clinical trials.",4.0,,,f,,,,t,t,f,,,,,,Individual participant data will be shared after deidentification and made available starting 6 months after initial product approval.,"Criteria will depend on the specific proposal received and may include qualification of the scientific researchers, potential contribution to the research field, scientific rigor of statistical and analytical methods, and other criteria appropriate for the proposal.",,YES,Vaxcyte is committed to providing access to anonymized data from the company's clinical trials for the purpose of legitimate scientific research. Requests for data may be addressed to datasharing@vaxcyte.com. Requests must be accompanied by a detailed analysis plan and will be reviewed for scientific validity. Data will be made available after initial product approval. Sharing of data may require execution of a data-sharing agreement.,2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,INDUSTRY,,,,,,,2023,1.0
NCT03393858,,2018-01-03,,,2024-02-05,2018-01-03,2018-01-09,ACTUAL,,,,,,,2024-02-05,2024-02-07,ACTUAL,2017-12-01,ACTUAL,2017-12-01,2024-02,2024-02-29,2022-06-30,ACTUAL,2022-06-30,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,,,Combination of Immunotherapy and Hyperthermia in Advanced Malignant Mesothelioma,A Prospective Study of Combination of Anti-PD-1 Plus Autologous DC-CIK Cell Immunotherapy and Hyperthermia for Patients With Advanced Malignant Mesothelioma,TERMINATED,,PHASE1/PHASE2,10.0,ACTUAL,Capital Medical University,,1.0,,The number of enrolled cases is insufficient,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,OTHER,,,,,,,2022,0.0
NCT04205240,,2019-12-17,2022-06-23,,2023-09-06,2019-12-18,2019-12-19,ACTUAL,2023-09-06,2023-09-28,ACTUAL,,,,2023-09-06,2023-09-28,ACTUAL,2020-12-22,ACTUAL,2020-12-22,2023-09,2023-09-30,2021-11-22,ACTUAL,2021-11-22,2021-05-08,ACTUAL,2021-05-08,,INTERVENTIONAL,,,Reduce Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed Multiple Myeloma,Reduce Intensity Conditioning (RIC) Allogenic Hematopoietic Stem Cell Transplantation (Allo HSCT) for Patients With Relapsed Multiple Myeloma: A Pilot Study,TERMINATED,,PHASE2,1.0,ACTUAL,Ohio State University Comprehensive Cancer Center,The trial was terminated early due to poor patient accrual,1.0,,Poor accrual,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2021,0.0
NCT02337413,,2015-01-01,,,2018-04-09,2015-01-08,2015-01-13,ESTIMATED,,,,,,,2018-04-09,2018-04-11,ACTUAL,2020-06,ESTIMATED,2020-06-30,2018-04,2018-04-30,2020-12,ESTIMATED,2020-12-31,2020-07,ESTIMATED,2020-07-31,,INTERVENTIONAL,,,Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis,"A Controlled Randomized, Physician Blinded Study to Assess Isolated Uro-therapy vs. Urotherapy With Constipation Treatment for Patients With Moderate-severe Monosymptomatic Nocturnal Enuresis (MNE) Not Meeting ROME-III Constipation Criteria",WITHDRAWN,,PHASE4,0.0,ACTUAL,Rabin Medical Center,,2.0,,Changes in departmental staff have led to a cut in research alotments.,f,,,,f,f,f,,,,,,,,,,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2020,0.0
NCT03709082,,2018-10-09,,,2024-03-01,2018-10-15,2018-10-17,ACTUAL,,,,,,,2024-03-01,2024-03-05,ACTUAL,2018-10-15,ACTUAL,2018-10-15,2024-03,2024-03-31,2021-02-03,ACTUAL,2021-02-03,2020-03-12,ACTUAL,2020-03-12,,INTERVENTIONAL,,,Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer,"A Phase I/II Study of Palbociclib, Letrozole and T-DM1 in Trastuzumab Refractory Estrogen Receptor Positive (ER+) and HER2 Positive Metastatic Breast Cancer",TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,University of Kansas Medical Center,,4.0,,Low accrual,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,OTHER,,,,,,,2021,0.0
NCT03650400,,2018-08-27,2020-07-01,,2021-10-07,2018-08-27,2018-08-28,ACTUAL,2020-07-01,2020-07-20,ACTUAL,,,,2021-10-07,2021-10-11,ACTUAL,2019-05-01,ACTUAL,2019-05-01,2021-10,2021-10-31,2020-01-22,ACTUAL,2020-01-22,2019-12-16,ACTUAL,2019-12-16,,INTERVENTIONAL,,,"Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to < 12 Years With Asthma","A Multicenter, Open-label, 8 Day Treatment Study to Assess the Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to <12 Years With Asthma",TERMINATED,,PHASE2,11.0,ACTUAL,Novartis,,2.0,,Company Decision,f,,,,f,t,f,,,,,,,,https://www.clinicalstudydatarequest.com/,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com https://www.clinicalstudydatarequest.com/",2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,INDUSTRY,,,,,,,2020,0.0
NCT04472611,,2020-07-14,2022-12-20,,2023-04-25,2020-07-14,2020-07-15,ACTUAL,2023-04-25,2023-04-27,ACTUAL,,,,2023-04-25,2023-04-27,ACTUAL,2020-10-30,ACTUAL,2020-10-30,2023-04,2023-04-30,2022-03-30,ACTUAL,2022-03-30,2022-03-30,ACTUAL,2022-03-30,,INTERVENTIONAL,COLSTAT,Patients hospitalized with moderate to severe symptoms of COVID being treated with standard protocol medications as set by hospital,Colchicine/Statins for the Prevention of COVID-19 Complications (COLSTAT) Trial,Colchicine/Statins for the Prevention of COVID-19 Complications (COLSTAT) Trial,COMPLETED,,PHASE3,250.0,ACTUAL,Yale University,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2022,0.0
NCT03812380,,2018-05-24,2022-07-20,,2022-07-20,2019-01-17,2019-01-23,ACTUAL,2022-07-20,2022-08-17,ACTUAL,,,,2022-07-20,2022-08-17,ACTUAL,2019-01-01,ACTUAL,2019-01-01,2022-07,2022-07-31,2021-08-11,ACTUAL,2021-08-11,2021-08-11,ACTUAL,2021-08-11,,INTERVENTIONAL,,,Averting Complications of Proton Pump Inhibitor Therapy by Effervescent Calcium Magnesium Citrate,Averting Complications of Proton Pump Inhibitor Therapy by Effervescent Calcium Magnesium Citrate,TERMINATED,,PHASE3,62.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,The study was terminated due to a severe decrease in enrollment over the years 2020 and 2021. The major obstacle which hindered participation of subjects was the COVID-19 pandemic. Research was halted. Remaining study patients were withdrawn.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2021,0.0
NCT05085964,,2021-10-07,2022-11-11,,2024-07-11,2021-10-19,2021-10-20,ACTUAL,2022-12-12,2022-12-27,ACTUAL,,,,2024-07-11,2024-08-07,ACTUAL,2021-09-16,ACTUAL,2021-09-16,2022-12,2022-12-31,2022-10-18,ACTUAL,2022-10-18,2022-10-18,ACTUAL,2022-10-18,,INTERVENTIONAL,HELIA,No participants were enrolled to the 60ug/60ug treatment group for either eye.,An Open-Label Extension Study to Evaluate Safety & Tolerability of QR-421a in Subjects With Retinitis Pigmentosa,An Open-Label Extension Study to Evaluate the Safety and Tolerability of QR 421a in Subjects With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene (Helia),TERMINATED,,PHASE2,21.0,ACTUAL,Laboratoires Thea,Study prematurely terminated due to sponsor decision for reasons unrelated to safety.,1.0,,The sponsor decided to terminate the study early,,,,,f,t,f,,,,,,,,,NO,,2024-10-16 13:53:24.929206,2024-10-16 13:53:24.929206,INDUSTRY,,,,,,,2022,0.0
NCT03790111,,2018-12-25,2022-12-16,,2023-04-17,2018-12-27,2018-12-31,ACTUAL,2023-04-17,2023-04-19,ACTUAL,,,,2023-04-17,2023-04-19,ACTUAL,2019-03-13,ACTUAL,2019-03-13,2023-04,2023-04-30,2022-01-13,ACTUAL,2022-01-13,2022-01-13,ACTUAL,2022-01-13,,INTERVENTIONAL,TELE-ABC,Safety Population,A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer,"A Phase 2, Multicenter, Open-label, Safety and Efficacy Study of XERMELO® (Telotristat Ethyl) Plus First-line Chemotherapy in Patients With Locally Advanced, Unresectable, Recurrent or Metastatic Biliary Tract Cancer (BTC)",TERMINATED,,PHASE2,53.0,ACTUAL,TerSera Therapeutics LLC,"This study was halted prematurely as it did not meet pre-specified Progression-Free Survival at Month 6 for Stage 2 Analysis.~Due to early discontinuation of the study with limited data, the study results (data) at Month 12 and End of Study may be unreliable and uninterpretable.",1.0,,Did not meet pre-specified Progression-Free Survival at Month 6 for Stage 2 Analysis,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,INDUSTRY,,,,,,,2022,0.0
NCT05017584,,2021-08-03,,,2022-05-23,2021-08-17,2021-08-24,ACTUAL,,,,,,,2022-05-23,2022-05-27,ACTUAL,2023-01,ESTIMATED,2023-01-31,2022-05,2022-05-31,2024-01-01,ESTIMATED,2024-01-01,2024-01-01,ESTIMATED,2024-01-01,,INTERVENTIONAL,,,ED90 of 0.75% Bupivacaine for Bilateral Tubal Ligation (BTL),Determining the ED90 for Intrathecal 0.75% Hyperbaric Bupivacaine for Bilateral Tubal Ligation,WITHDRAWN,,PHASE4,0.0,ACTUAL,Duke University,,4.0,,"Study halted prematurely, prior to enrollment of first participant",f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,OTHER,,,,,,,2024,0.0
NCT04081337,,2019-09-05,2023-05-26,,2023-05-26,2019-09-05,2019-09-09,ACTUAL,2023-05-26,2024-02-08,ACTUAL,,,,2023-05-26,2024-02-08,ACTUAL,2020-07-09,ACTUAL,2020-07-09,2023-05,2023-05-31,2022-05-26,ACTUAL,2022-05-26,2022-05-26,ACTUAL,2022-05-26,,INTERVENTIONAL,,All randomized participants who received at least one dose of study drug.,A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide,"A Randomized, Placebo-Controlled, Parallel-Arm Study to Investigate the Effect of Once-Weekly Tirzepatide on Energy Expenditure and Food Intake in Obese Subjects",COMPLETED,,PHASE1,55.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,INDUSTRY,,,,,,,2022,1.0
NCT03880279,,2019-03-13,,,2022-02-07,2019-03-18,2019-03-19,ACTUAL,,,,,,,2022-02-07,2022-02-23,ACTUAL,2020-05,ESTIMATED,2020-05-31,2022-02,2022-02-28,2024-04,ESTIMATED,2024-04-30,2022-04,ESTIMATED,2022-04-30,,INTERVENTIONAL,TACTIC-19,,Autologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma,A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC T Cells Targeting CD19 in Relapsed or Refractory Large B-Cell Lymphoma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Triumvira Immunologics, Inc.",,1.0,,"Following a change in company governance, Triumvira terminated the study prior to enrolling any subjects due to a challenging competitive landscape.",f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,INDUSTRY,,,,,,,2024,0.0
NCT04936971,,2021-06-16,,,2024-02-26,2021-06-16,2021-06-23,ACTUAL,,,,,,,2024-02-26,2024-02-28,ACTUAL,2021-09,ESTIMATED,2021-09-30,2021-06,2021-06-30,2021-09,ESTIMATED,2021-09-30,2021-09,ESTIMATED,2021-09-30,,INTERVENTIONAL,ACTIVA,,Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response,Effect of the Introduction of mTor Inhibitors in the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response to Control Viral Replication in Kidney Transplant Patients,WITHDRAWN,,PHASE4,0.0,ACTUAL,Hospital Universitari de Bellvitge,,2.0,,Impossibility to perform tests (elispot) of the study due to change of location of laboratory,f,,,,f,f,f,,,,,,,,,,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,OTHER,,,,,,,2021,0.0
NCT02527681,,2015-08-05,2020-12-11,,2023-05-09,2015-08-17,2015-08-19,ESTIMATED,2020-12-11,2021-01-06,ACTUAL,,,,2023-05-09,2023-06-05,ACTUAL,2016-11-22,ACTUAL,2016-11-22,2023-05,2023-05-31,2020-02-25,ACTUAL,2020-02-25,2020-02-25,ACTUAL,2020-02-25,,INTERVENTIONAL,,,Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics,An Open-label Study to Evaluate the Single-dose Pharmacokinetics and Safety of Ceftobiprole in Neonate and Infant Subjects Aged up to 3 Months Undergoing Treatment With Systemic Antibiotics,TERMINATED,,PHASE1,15.0,ACTUAL,Basilea Pharmaceutica,,1.0,,"on July 07, 2020 due to slow enrollment; there were no safety concerns.",f,,,,f,t,f,,,,,,,,,,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,INDUSTRY,,,,,,,2020,0.0
NCT02728037,,2015-10-26,,,2023-03-28,2016-04-04,2016-04-05,ESTIMATED,,,,,,,2023-03-28,2023-03-31,ACTUAL,2016-04,,2016-04-30,2023-03,2023-03-31,2020-04,ACTUAL,2020-04-30,2020-03,ACTUAL,2020-03-31,,INTERVENTIONAL,,,Magnesium-Based Trigger Point Injections for Relief of Chronic Myofascial Pelvic Pain,Randomized Control Trial of Magnesium-Based Trigger Point Injections vs. Lidocaine-Only Trigger Point Injections for Relief of Chronic Myofascial Pelvic Pain,TERMINATED,,PHASE3,38.0,ACTUAL,Queen's University,,3.0,,"Low Enrollment, Adoption of investigational treatment into standard practice at our center.",f,,,,f,,,,,,,,,,,,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,OTHER,,,,,,,2020,0.0
NCT03443869,,2018-02-19,2023-03-23,,2023-07-26,2018-02-19,2018-02-23,ACTUAL,2023-03-23,2023-04-14,ACTUAL,,,,2023-07-26,2023-07-28,ACTUAL,2018-05-03,ACTUAL,2018-05-03,2023-07,2023-07-31,2022-04-05,ACTUAL,2022-04-05,2022-04-05,ACTUAL,2022-04-05,,INTERVENTIONAL,,,Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002),"A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients",COMPLETED,,PHASE3,601.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,INDUSTRY,,,,,,,2022,1.0
NCT05152641,,2021-11-29,,,2022-04-29,2021-11-29,2021-12-10,ACTUAL,,,,,,,2022-04-29,2022-05-05,ACTUAL,2022-04,ESTIMATED,2022-04-30,2022-04,2022-04-30,2024-07,ESTIMATED,2024-07-31,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,,,Study to Evaluate Efficacy and Safety of BGE-117 in Moderately to Severely Anemic Older Individuals After Major Hip Surgery,"A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Investigating the Efficacy and Safety of BGE-117 in Moderately to Severely Anemic Older Individuals After Major Hip Surgery",WITHDRAWN,,PHASE2,0.0,ACTUAL,"BioAge Labs, Inc.",,4.0,,The program priority for execution of this clinical trial changed prior to enrollment of the first patient. The study was not withdrawn due to any safety concerns.,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,INDUSTRY,,,,,,,2024,0.0
NCT03850509,,2019-02-15,2021-05-19,,2021-05-19,2019-02-20,2019-02-21,ACTUAL,2021-05-19,2021-06-15,ACTUAL,,,,2021-05-19,2021-06-15,ACTUAL,2020-02-25,ACTUAL,2020-02-25,2021-05,2021-05-31,2020-05-22,ACTUAL,2020-05-22,2020-05-22,ACTUAL,2020-05-22,,INTERVENTIONAL,,The Randomized Set included all participants who were randomized into this trial.,Efficacy and Safety of Oral OPS-2071 in Participants With Crohn's Disease Showing Symptoms of Active Inflammation,"A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn's Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment",TERMINATED,,PHASE2,3.0,ACTUAL,"Otsuka Pharmaceutical Development & Commercialization, Inc.",,4.0,,Sponsor Decision,f,,,,t,t,f,,,,,,"Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.",Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com,https://clinical-trials.otsuka.com,YES,Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,INDUSTRY,,,,,,,2020,0.0
NCT03533946,,2018-04-26,2023-09-20,,2024-02-14,2018-05-10,2018-05-23,ACTUAL,2024-02-14,2024-03-13,ACTUAL,,,,2024-02-14,2024-03-13,ACTUAL,2019-05-20,ACTUAL,2019-05-20,2024-02,2024-02-29,2023-01-12,ACTUAL,2023-01-12,2023-01-12,ACTUAL,2023-01-12,,INTERVENTIONAL,ROAR,,Rucaparib in Nonmetastatic prOstAte With BRCAness,"A Phase II Study of Rucaparib Monotherapy in Nonmetastatic, Hormone-Sensitive Prostate Cancer Demonstrating BRCAness Genotype (ROAR)",TERMINATED,,PHASE2,7.0,ACTUAL,University of Utah,,1.0,,New standard of care for study participant population,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,OTHER,,,,,,,2023,0.0
NCT03186209,,2017-05-19,2023-09-14,,2024-03-28,2017-06-12,2017-06-14,ACTUAL,2024-03-28,2024-04-24,ACTUAL,,,,2024-03-28,2024-04-24,ACTUAL,2017-09-07,ACTUAL,2017-09-07,2024-03,2024-03-31,2023-01-30,ACTUAL,2023-01-30,2023-01-30,ACTUAL,2023-01-30,,INTERVENTIONAL,,"Full analysis set, all participants who were randomized and received at least one investigational product (IP), Benralizumab or Placebo.",Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE),"A Multicentre, Randomised, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Efficacy and Safety Study of Benralizumab (MEDI-563) Added to Medium to High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma.",COMPLETED,,PHASE3,695.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,f,t,f,,,t,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,INDUSTRY,,,,,,,2023,1.0
NCT02774460,,2016-03-30,,,2021-08-31,2016-05-12,2016-05-17,ESTIMATED,,,,,,,2021-08-31,2021-09-01,ACTUAL,2017-02-20,ACTUAL,2017-02-20,2021-08,2021-08-31,2021-06-11,ACTUAL,2021-06-11,2021-06-11,ACTUAL,2021-06-11,,INTERVENTIONAL,PHYSIC,,The Precision Hypertension Care Study,The Precision Hypertension Care Study,COMPLETED,,PHASE4,280.0,ACTUAL,Uppsala University,,7.0,,,f,,,,f,f,f,,,f,,,,,,,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2021,1.0
NCT03908255,,2018-12-07,,,2022-01-13,2019-04-08,2019-04-09,ACTUAL,,,,,,,2022-01-13,2022-01-28,ACTUAL,2021-06-01,ESTIMATED,2021-06-01,2021-08,2021-08-31,2023-12-30,ESTIMATED,2023-12-30,2022-12-30,ESTIMATED,2022-12-30,,INTERVENTIONAL,BCAA in HCC,,Branched-chain Amino Acid Supplementation for Hepatocellular Carcinoma,Impact of Branched-chain Amino Acid Supplementation on Quality of Life and Overall Survival in Patients Receiving Liver Directed Therapy for Hepatocellular Carcinoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,Louisiana State University Health Sciences Center in New Orleans,,2.0,,Dr. Marshall left UMC and LSU Health Sciences Center.,f,,,,f,t,f,,,,,,"The time frame for data sharing will begin after initial publication and will extend for 5 years.~After this point, data will be purged from secured servers and will no longer be available for sharing.","A request for data will be made through the principal investigator of this study, who is responsible for data storage. Requests will be made to local Institutional Review Boards prior to de-identified data release.",,YES,"Individual participant data may be shared in collaboration with the current investigators for future studies in which branched chain amino acids for treatment of liver disease are studied in a similar manner to this protocol. All collected data may be made available after local Institutional Review Board authorization, de-identification through a secure method of data transfer (encrypted file sharing) and kept on a secure server.",2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,OTHER,,,,,,,2023,0.0
NCT00410956,,2006-12-11,,,2024-05-07,2006-12-11,2006-12-13,ESTIMATED,,,,,,,2024-05-07,2024-05-09,ACTUAL,2007-05-09,ACTUAL,2007-05-09,2024-05,2024-05-31,2024-05-07,ACTUAL,2024-05-07,2024-05-07,ACTUAL,2024-05-07,,INTERVENTIONAL,,,Floxuridine and Dexamethasone as a Hepatic Arterial Infusion and Bevacizumab in Treating Patients With Primary Liver Cancer That Cannot be Removed by Surgery,"A Phase II Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Bevacizumab (A Monoclonal Antibody to Vascular Endothelial Growth Factor-A), in Patients With Unresectable Primary Hepatic Malignancy",COMPLETED,,PHASE2,22.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,OTHER,,,,,,,2024,0.0
NCT03867851,,2019-03-05,,,2024-05-13,2019-03-06,2019-03-08,ACTUAL,,,,,,,2024-05-13,2024-05-16,ACTUAL,2021-02-08,ACTUAL,2021-02-08,2024-05,2024-05-31,2024-05-13,ACTUAL,2024-05-13,2024-05-13,ACTUAL,2024-05-13,,INTERVENTIONAL,,,Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation,"Open, Randomized, Active Comparator-controlled, Multi-Center Study to Evaluate Safety and Efficacy of IBsolvMIR® in Islet Transplantation",TERMINATED,,PHASE2,7.0,ACTUAL,TikoMed AB,,2.0,,Slow patient recruitment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,INDUSTRY,,,,,,,2024,0.0
NCT03702621,,2018-08-06,2021-05-22,,2023-05-15,2018-10-09,2018-10-11,ACTUAL,2023-05-15,2023-05-17,ACTUAL,,,,2023-05-15,2023-05-17,ACTUAL,2018-08-30,ACTUAL,2018-08-30,2023-05,2023-05-31,2020-03-13,ACTUAL,2020-03-13,2020-03-13,ACTUAL,2020-03-13,,INTERVENTIONAL,,,Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery,Liposomal Bupivacaine Versus Standard Bupivacaine Hydrochloride In Colorectal Surgery,COMPLETED,,PHASE3,90.0,ACTUAL,Indiana University,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,OTHER,,,,,,,2020,1.0
NCT03895099,,2019-03-28,,,2023-11-03,2019-03-28,2019-03-29,ACTUAL,,,,,,,2023-11-03,2023-11-07,ACTUAL,2020-09-04,ACTUAL,2020-09-04,2023-11,2023-11-30,2023-10-30,ACTUAL,2023-10-30,2023-10-30,ACTUAL,2023-10-30,,INTERVENTIONAL,RANDOS,,"New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors","Feasibility and Efficacy of a New Ovarian Stimulation Regimen With RANDom Start, Use of Corifollitropin Alpha and Progestin Protocol for Oocyte donorS",COMPLETED,,PHASE3,110.0,ACTUAL,Centre Hospitalier Intercommunal Creteil,,5.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,OTHER,,,,,,,2023,1.0
NCT04485052,,2020-07-21,,,2023-10-20,2020-07-21,2020-07-24,ACTUAL,,,,,,,2023-10-20,2023-10-23,ACTUAL,2020-09-25,ACTUAL,2020-09-25,2023-10,2023-10-31,2024-12-31,ESTIMATED,2024-12-31,2024-06-30,ESTIMATED,2024-06-30,,INTERVENTIONAL,,,Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia,A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Demethylating Agents in Subjects With Acute Myeloid Leukemia,SUSPENDED,,PHASE1/PHASE2,222.0,ESTIMATED,Innovent Biologics (Suzhou) Co. Ltd.,,2.0,,Pause for changes in development strategies,f,,,,f,f,f,,,,,,,,,,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,INDUSTRY,,,,,,,2024,0.0
NCT02637076,,2015-12-17,2021-02-02,,2021-02-26,2015-12-18,2015-12-22,ESTIMATED,2021-02-26,2021-03-23,ACTUAL,,,,2021-02-26,2021-03-23,ACTUAL,2016-01,,2016-01-31,2021-02,2021-02-28,2020-01-23,ACTUAL,2020-01-23,2020-01-23,ACTUAL,2020-01-23,,INTERVENTIONAL,,,Xyrem and Brain Dopamine in Narcolepsy,Does Xyrem Influence Brain Dopamine in Patients With Narcolepsy? A PET Imaging Investigation,COMPLETED,,PHASE4,17.0,ACTUAL,Centre for Addiction and Mental Health,,2.0,,,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,OTHER,,,,,,,2020,1.0
NCT05409183,,2022-06-03,,,2023-11-02,2022-06-03,2022-06-08,ACTUAL,,,,,,,2023-11-02,2023-11-07,ACTUAL,2022-05-26,ACTUAL,2022-05-26,2023-11,2023-11-30,2023-07-25,ACTUAL,2023-07-25,2023-05-02,ACTUAL,2023-05-02,,INTERVENTIONAL,CARDINAL-HF,,Effectiveness of CRD-740 in Heart Failure,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effectiveness of CRD-740 in Subjects With Chronic Heart Failure (CARDINAL-HF)",TERMINATED,,PHASE2,60.0,ACTUAL,"Cardurion Pharmaceuticals, Inc.",,2.0,,Part A of the study was successfully concluded. Part B of the study was discontinued in favor of redesigned new studies.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,INDUSTRY,,,,,,,2023,0.0
NCT04483700,,2020-07-20,,,2021-01-07,2020-07-20,2020-07-23,ACTUAL,,,,,,,2021-01-07,2021-01-11,ACTUAL,2020-12,ESTIMATED,2020-12-31,2021-01,2021-01-31,2024-06,ESTIMATED,2024-06-30,2022-10,ESTIMATED,2022-10-31,,INTERVENTIONAL,SEALION2-NAÏVE,,Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug Therapy,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug Therapy",WITHDRAWN,,PHASE3,0.0,ACTUAL,Gilead Sciences,,5.0,,Development program terminated,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,INDUSTRY,,,,,,,2024,0.0
NCT04761601,,2021-02-16,,,2024-03-11,2021-02-16,2021-02-21,ACTUAL,,,,,,,2024-03-11,2024-03-13,ACTUAL,2021-03-03,ACTUAL,2021-03-03,2024-03,2024-03-31,2024-02-29,ACTUAL,2024-02-29,2024-02-19,ACTUAL,2024-02-19,,INTERVENTIONAL,,,First in Human Study of UCT-01-097 in Participants With Advanced Solid Tumors,"A Phase 1, First in Human, Dose-Escalation Study of UCT-01-097 in Participants With Advanced Solid Tumors",TERMINATED,,PHASE1,32.0,ACTUAL,"1200 Pharma, LLC",,3.0,,"Stopped for strategic business reasons. The decision to stop the study was not connected to any safety concerns, or new risk associated with the study product, intervention, or procedures.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,INDUSTRY,,,,,,,2024,0.0
NCT02739542,,2016-03-16,2022-02-28,,2022-04-13,2016-04-14,2016-04-15,ESTIMATED,2022-04-13,2022-05-11,ACTUAL,,,,2022-04-13,2022-05-11,ACTUAL,2016-03-19,ACTUAL,2016-03-19,2022-04,2022-04-30,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,ARISE,,Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS),"Multi-center, Randomized, Double-blinded Assessment of Tecfidera® in Extending the Time to a First Attack in Radiologically Isolated Syndrome (RIS) (ARISE)",COMPLETED,,PHASE4,87.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,OTHER,,,,,,,2021,1.0
NCT04534283,,2020-08-27,2024-07-09,,2024-08-01,2020-08-27,2020-09-01,ACTUAL,2024-08-01,2024-08-07,ACTUAL,,,,2024-08-01,2024-08-07,ACTUAL,2020-10-05,ACTUAL,2020-10-05,2024-08,2024-08-31,2023-08-07,ACTUAL,2023-08-07,2023-08-07,ACTUAL,2023-08-07,,INTERVENTIONAL,,All enrolled patients who received at least one dose of study treatment.,A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib.,"A Phase 2 Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib for Patients Whose Tumors Harbor Pathogenic Alterations in BRAF, RAF1, MEK1/2, ERK1/2, and NF1.",TERMINATED,,PHASE2,16.0,ACTUAL,Indiana University,Early termination leading to smaller number of patients enrolled than planned.,1.0,,Lack of efficacy.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,OTHER,,,,,,,2023,0.0
NCT03814109,,2019-01-22,,,2022-07-25,2019-01-22,2019-01-23,ACTUAL,,,,,,,2022-07-25,2022-07-27,ACTUAL,2022-04,ESTIMATED,2022-04-30,2022-07,2022-07-31,2024-01,ESTIMATED,2024-01-31,2023-11,ESTIMATED,2023-11-30,,INTERVENTIONAL,,,Efficacy and Safety of Leningrado Association in the Treatment of Hypertension,"Randomized, Double-blind, Triple-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Leningrado Association in the Treatment of Hypertension",WITHDRAWN,,PHASE3,0.0,ACTUAL,EMS,,3.0,,Sponsor decision,f,,,,t,f,f,,,,,,,,,,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,INDUSTRY,,,,,,,2024,0.0
NCT03452540,,2018-02-26,2022-07-05,,2022-07-05,2018-02-26,2018-03-02,ACTUAL,2022-07-05,2022-07-29,ACTUAL,,,,2022-07-05,2022-07-29,ACTUAL,2018-11-28,ACTUAL,2018-11-28,2022-07,2022-07-31,2020-03-31,ACTUAL,2020-03-31,2019-06-19,ACTUAL,2019-06-19,,INTERVENTIONAL,,"The Full Analysis Set (FAS) included all patients who received at least one dose of investigational product. Patients were analysed according to the treatment they were assigned to, irrespective of what treatment they actually received.",Efficacy and Safety of Orally Administered DS102 in Patients With Acute Alcoholic Hepatitis,"A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS102 in Patients With Acute Decompensated Alcoholic Hepatitis.",TERMINATED,,PHASE2,9.0,ACTUAL,Afimmune,"Early termination - The study was stopped at the end of the pilot phase (n=9) as the sponsor prioritised other therapeutic indications, so no patients were enrolled in the double-blind phase.",1.0,,Company Decision,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,INDUSTRY,,,,,,,2020,0.0
NCT03953170,,2019-04-15,,,2023-02-21,2019-05-14,2019-05-16,ACTUAL,,,,,,,2023-02-21,2023-02-23,ACTUAL,2022-06-02,ACTUAL,2022-06-02,2023-02,2023-02-28,2022-12-29,ACTUAL,2022-12-29,2022-11-25,ACTUAL,2022-11-25,,INTERVENTIONAL,,,Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications,Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications,WITHDRAWN,,PHASE3,0.0,ACTUAL,Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute),,2.0,,Funding ended,f,,,,f,t,f,,,t,,,,,,NO,"De-identified study data will be shared with study sponsor (Shire Human Genetics Therapies, Inc)",2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,OTHER,,,,,,,2022,0.0
NCT04241159,,2020-01-13,,,2020-05-21,2020-01-23,2020-01-27,ACTUAL,,,,,,,2020-05-21,2020-05-22,ACTUAL,2020-05,ESTIMATED,2020-05-31,2019-11,2019-11-30,2020-08,ESTIMATED,2020-08-31,2020-08,ESTIMATED,2020-08-31,,INTERVENTIONAL,,,Study to Explore the Safety and Feasibility of Allogeneic Young Plasma Infusion in Older Adults,A Small-Scale Study to Explore the Safety and Feasibility of Allogeneic Young Plasma Infusion in Older Adults Experiencing Disability Across the Spectrum of Frailty Syndrome,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,Protocol required revisions and application was withdrawn from the IRB.,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,OTHER,,,,,,,2020,0.0
NCT03728465,,2018-10-19,,,2021-01-29,2018-10-31,2018-11-02,ACTUAL,,,,,,,2021-01-29,2021-02-03,ACTUAL,2018-04-10,ACTUAL,2018-04-10,2018-10,2018-10-31,2021-01-01,ACTUAL,2021-01-01,2021-01-01,ACTUAL,2021-01-01,,INTERVENTIONAL,,,Evaluation of Safety and Efficacy of Patients With Four and More Symptomatic Brain Metastases of Melanoma,An Open Label Phase II Study to Evaluate Safety and Efficacy of Combined Treatment With Ipilimumab and Nivolumab in Patients With Four and More Symptomatic Brain Metastases of Melanoma,TERMINATED,,PHASE2,6.0,ACTUAL,University Hospital Tuebingen,,1.0,,Lack of patients,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2021,0.0
NCT05096884,,2021-10-25,,,2024-01-10,2021-10-25,2021-10-27,ACTUAL,,,,,,,2024-01-10,2024-01-11,ACTUAL,2022-03-23,ACTUAL,2022-03-23,2024-01,2024-01-31,2023-09-12,ACTUAL,2023-09-12,2023-09-12,ACTUAL,2023-09-12,,INTERVENTIONAL,PEACE,,Post-Acute Sequelae of Coronavirus-19 (COVID-19) With Dyspnea on Exertion And Associated TaChycardia TrEatment Study,Post-Acute Sequelae of Coronavirus-19 (COVID-19) With DysPnEA on ExertIon And Associated TaChycardia TrEatment Study,TERMINATED,,EARLY_PHASE1,14.0,ACTUAL,Hackensack Meridian Health,,1.0,,Low accrual,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,OTHER,,,,,,,2023,0.0
NCT03474614,,2018-03-05,,,2024-04-17,2018-03-15,2018-03-22,ACTUAL,,,,,,,2024-04-17,2024-04-19,ACTUAL,2018-01-24,ACTUAL,2018-01-24,2024-04,2024-04-30,2021-02-11,ACTUAL,2021-02-11,2021-02-11,ACTUAL,2021-02-11,,INTERVENTIONAL,,,Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation,Effect of Oral Propranolol on mRNA Expression in Symptomatice Caavernous Malformation,TERMINATED,,PHASE2,4.0,ACTUAL,"St. Joseph's Hospital and Medical Center, Phoenix",,2.0,,lack of accrual,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2021,0.0
NCT02737306,,2016-03-29,2024-02-14,,2024-02-14,2016-04-12,2016-04-13,ESTIMATED,2024-02-14,2024-03-12,ACTUAL,,,,2024-02-14,2024-03-12,ACTUAL,2017-05-14,ACTUAL,2017-05-14,2022-01,2022-01-31,2021-09-30,ACTUAL,2021-09-30,2021-04-14,ACTUAL,2021-04-14,,INTERVENTIONAL,GVHD,The Intent-to-Treat (ITT) population is defined as the set of subjects who are randomized to PRO 140 or placebo. The ITT population will be the primary analysis population for the analysis of primary and secondary endpoints,A Study of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Stem-Cell Transplantation,"A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of PRO 140 for Prophylaxis of Acute Graft-Versus-Host Disease in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)",TERMINATED,,PHASE2,11.0,ACTUAL,"CytoDyn, Inc.",This study was stopped prior to completion due to lack of enrolment.,2.0,,Study terminated due to lack of enrolment..,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 13:59:37.431135,2024-10-16 13:59:37.431135,INDUSTRY,,,,,,,2021,0.0
NCT03636555,,2018-08-14,,,2019-11-11,2018-08-15,2018-08-17,ACTUAL,,,,,,,2019-11-11,2019-11-13,ACTUAL,2019-10,ESTIMATED,2019-10-31,2019-11,2019-11-30,2022-09,ESTIMATED,2022-09-30,2022-09,ESTIMATED,2022-09-30,,INTERVENTIONAL,OT-ETOH-4,,Oxytocin Treatment for Alcohol Use Disorders,"Intranasal Oxytocin Treatment for Alcohol Use Disorders: A Randomized, Placebo-Controlled Trial",WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,PI no longer employed at Institution,f,,,,t,t,f,,,,,,9 to 36 months following publication,"The investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.",,YES,Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2022,0.0
NCT03996486,,2019-06-21,,,2019-10-21,2019-06-21,2019-06-24,ACTUAL,,,,,,,2019-10-21,2019-10-22,ACTUAL,2019-10-28,ESTIMATED,2019-10-28,2019-10,2019-10-31,2020-07-31,ESTIMATED,2020-07-31,2020-05-29,ESTIMATED,2020-05-29,,INTERVENTIONAL,,,Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia,"A Multicenter, Non-randomized, Open-label, Multiple Dose Escalation Study to Evaluate the Safety and Tolerability of Subcutaneous BAY1093884 in Males With Severe Hemophilia",WITHDRAWN,,PHASE1,0.0,ACTUAL,Bayer,,1.0,,Company decision,f,,,,f,t,f,,,,,,,,,UNDECIDED,"Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.",2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,INDUSTRY,,,,,,,2020,0.0
NCT04685421,,2020-12-22,,,2023-06-01,2020-12-22,2020-12-28,ACTUAL,,,,,,,2023-06-01,2023-06-05,ACTUAL,2021-07-15,ACTUAL,2021-07-15,2023-06,2023-06-30,2023-06-01,ACTUAL,2023-06-01,2023-06-01,ACTUAL,2023-06-01,,INTERVENTIONAL,CohortI-II,,Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery,Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery,TERMINATED,,PHASE1,15.0,ACTUAL,Nicklaus Children's Hospital f/k/a Miami Children's Hospital,,1.0,,"PI, Christopher Tirotta, no longer at NCH as of 5-26-23.",f,,,,t,t,f,,,,,,one year after study closure,Information will be provided by request to the PI,,YES,De-identified will be posted in website.,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,OTHER,,,,,,,2023,0.0
NCT04762511,,2021-02-17,,,2021-06-24,2021-02-17,2021-02-21,ACTUAL,,,,,,,2021-06-24,2021-06-28,ACTUAL,2021-03-02,ACTUAL,2021-03-02,2021-06,2021-06-30,2021-05-26,ACTUAL,2021-05-26,2021-05-26,ACTUAL,2021-05-26,,INTERVENTIONAL,,,"A Study on the Reactogenicity, Safety and Immune Response of a Vaccine Against Herpes Simplex Virus (HSV)-2 in Healthy Participants Aged 18-40 Years","A Phase I, Single-blind, Randomised, Placebo-controlled, Dose Escalation Study to Evaluate the Reactogenicity, Safety and Immune Response of an HSV Vaccine in Healthy Participants Aged 18-40 Years",TERMINATED,,PHASE1,17.0,ACTUAL,GlaxoSmithKline,,8.0,,To enable development of an enhanced version of the vaccine,f,,,,f,t,f,,,f,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,INDUSTRY,,,,,,,2021,0.0
NCT03600909,,2018-07-17,2022-02-21,,2022-03-21,2018-07-17,2018-07-26,ACTUAL,2022-03-21,2022-04-12,ACTUAL,,,,2022-03-21,2022-04-12,ACTUAL,2018-05-15,ACTUAL,2018-05-15,2021-04,2021-04-30,2021-04-09,ACTUAL,2021-04-09,2021-04-09,ACTUAL,2021-04-09,,INTERVENTIONAL,,Study closed due to slow accrual,A Study of the Effect of Blood Stem Cell Transplant After Chemotherapy Alone in Patients With Fanconi Anemia,"A Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Risk-Adjusted Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine",TERMINATED,,PHASE2,3.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,3.0,,Accrual has been slow,,,,,,t,t,,,,,,,,,,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2021,0.0
NCT04371978,,2020-04-30,,,2021-05-28,2020-04-30,2020-05-01,ACTUAL,,,,,,,2021-05-28,2021-06-02,ACTUAL,2020-10-01,ACTUAL,2020-10-01,2021-05,2021-05-31,2021-05-04,ACTUAL,2021-05-04,2021-04-04,ACTUAL,2021-04-04,,INTERVENTIONAL,,,Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19,Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19,TERMINATED,,PHASE3,64.0,ACTUAL,Rabin Medical Center,,2.0,,End of COVID-19 outbreak in Israel,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,OTHER,,,,,,,2021,0.0
NCT04588259,,2020-10-09,2023-07-05,,2024-03-16,2020-10-09,2020-10-19,ACTUAL,2024-03-16,2024-03-20,ACTUAL,,,,2024-03-16,2024-03-20,ACTUAL,2020-10-09,ACTUAL,2020-10-09,2024-03,2024-03-31,2022-08-05,ACTUAL,2022-08-05,2022-07-05,ACTUAL,2022-07-05,,INTERVENTIONAL,,Full analysis set (FAS) which included all randomised participants.,Research Study to Compare a New Medicine Fast-acting Insulin Aspart to Another Medicine Insulin Aspart in Chinese People With Diabetes,Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec With or Without Metformin in Adults With Diabetes,COMPLETED,,PHASE3,331.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,f,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,INDUSTRY,,,,,,,2022,1.0
NCT04299373,,2020-02-12,,,2024-02-01,2020-03-03,2020-03-06,ACTUAL,,,,,,,2024-02-01,2024-02-02,ACTUAL,2020-02-10,ACTUAL,2020-02-10,2024-02,2024-02-29,2022-09-09,ACTUAL,2022-09-09,2022-09-09,ACTUAL,2022-09-09,,INTERVENTIONAL,SWAP,,Surgical Weight Loss and Alcohol Perception,Effects of Metabolic Surgery on Alcohol Pharmacokinetics,TERMINATED,,EARLY_PHASE1,3.0,ACTUAL,University of Missouri-Columbia,,2.0,,In an effort to seek a more suitable method to measure alcohol clearance.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2022,0.0
NCT04649151,,2020-11-30,,,2024-07-29,2020-11-30,2020-12-02,ACTUAL,,,,,,,2024-07-29,2024-07-31,ACTUAL,2020-12-09,ACTUAL,2020-12-09,2024-07,2024-07-31,2024-06-14,ACTUAL,2024-06-14,2024-06-14,ACTUAL,2024-06-14,,INTERVENTIONAL,TeenCove,,"A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19","A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Adolescents 12 to <18 Years of Age",COMPLETED,,PHASE2/PHASE3,4331.0,ACTUAL,"ModernaTX, Inc.",,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,INDUSTRY,,,,,,,2024,1.0
NCT04487210,,2020-07-22,,,2022-01-27,2020-07-22,2020-07-27,ACTUAL,,,,,,,2022-01-27,2022-01-31,ACTUAL,2020-10-07,ACTUAL,2020-10-07,2021-08,2021-08-31,2021-12-06,ACTUAL,2021-12-06,2021-06-01,ACTUAL,2021-06-01,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Immunogenicity of MVC-COV1901 Against COVID-19,"A Phase I, Prospective, Open-Labeled Study to Evaluate the Safety and Immunogenicity of MVC-COV1901",COMPLETED,,PHASE1,45.0,ACTUAL,Medigen Vaccine Biologics Corp.,,3.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,INDUSTRY,,,,,,,2021,1.0
NCT06036511,,2023-08-03,,,2024-03-08,2023-09-06,2023-09-14,ACTUAL,,,,,,,2024-03-08,2024-03-12,ACTUAL,2023-12-31,ACTUAL,2023-12-31,2024-03,2024-03-31,2023-12-31,ACTUAL,2023-12-31,2023-12-31,ACTUAL,2023-12-31,,INTERVENTIONAL,CONCHKAP,,Connectivity Changes Associated With Ketamine Assisted Psychotherapy for PTSD,Connectivity Changes Associated With Ketamine Assisted Psychotherapy for PTSD,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of New Mexico,,1.0,,"Per PI, this trial will not be started at UNM due to change in institutional responsibilities of the PI",f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,OTHER,,,,,,,2023,0.0
NCT04359095,,2020-04-15,,,2021-08-04,2020-04-22,2020-04-24,ACTUAL,,,,,,,2021-08-04,2021-08-12,ACTUAL,2020-08-18,ACTUAL,2020-08-18,2021-08,2021-08-31,2021-06-30,ACTUAL,2021-06-30,2021-03-20,ACTUAL,2021-03-20,,INTERVENTIONAL,,,Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia,Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia: A Pragmatic Randomized Controlled Trial,COMPLETED,,PHASE2/PHASE3,650.0,ACTUAL,Universidad Nacional de Colombia,,4.0,,,f,,,,t,t,f,,,t,,,As soon we have checked the quality of data of recruited participants,Approved by the monitor committee of the study,,YES,Communicating trial results and data to be able to combine data from multiple studies (live SR),2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,OTHER,,,,,,,2021,1.0
NCT05167526,,2021-12-20,,,2023-11-08,2021-12-20,2021-12-22,ACTUAL,,,,,,,2023-11-08,2023-11-13,ACTUAL,2022-03-07,ACTUAL,2022-03-07,2023-11,2023-11-30,2022-11-10,ACTUAL,2022-11-10,2022-11-10,ACTUAL,2022-11-10,,INTERVENTIONAL,,,A Study to Find a Suitable Dose of ASP8731 and Check for Medical Problems at Each Dose in Healthy Adults,"A Phase 1 Combined Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP8731 in Healthy Adult Participants, Including an Assessment of a Food Effect",TERMINATED,,PHASE1,36.0,ACTUAL,Astellas Pharma Inc,,6.0,,The study was terminated due to protocol defined stopping criteria being met.,f,,,,t,t,f,,,,,,,,,NO,Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,INDUSTRY,,,,,,,2022,0.0
NCT03954639,,2019-05-15,,,2020-08-11,2019-05-16,2019-05-17,ACTUAL,,,,,,,2020-08-11,2020-08-13,ACTUAL,2020-06-15,ESTIMATED,2020-06-15,2020-05,2020-05-31,2020-09,ESTIMATED,2020-09-30,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,STRIDE,,"Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Analgesia in Lower Extremity Surgeries","A Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupivacaine vs. Bupivacaine Only Administered as Combined Sciatic (in Popliteal Fossa) and Adductor Canal Nerve Block for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Pacira Pharmaceuticals, Inc",,4.0,,Sponsor Decision.,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,INDUSTRY,,,,,,,2020,0.0
NCT04634409,,2020-11-17,2022-06-07,,2022-06-07,2020-11-17,2020-11-18,ACTUAL,2022-06-07,2022-07-01,ACTUAL,,,,2022-06-07,2022-07-01,ACTUAL,2020-10-29,ACTUAL,2020-10-29,2022-06,2022-06-30,2021-10-18,ACTUAL,2021-10-18,2021-07-27,ACTUAL,2021-07-27,,INTERVENTIONAL,BLAZE-4,All participants who received at least one dose of study drug.,A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness,"A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Mono and Combination Therapy With Monoclonal Antibodies in Participants With Mild to Moderate COVID-19 Illness (BLAZE-4)",COMPLETED,,PHASE2,1755.0,ACTUAL,Eli Lilly and Company,,6.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.","Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",http://vivli.org/,YES,,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,INDUSTRY,,,,,,,2021,1.0
NCT03519256,,2018-04-17,2023-05-03,,2023-05-31,2018-04-26,2018-05-08,ACTUAL,2023-05-31,2023-06-01,ACTUAL,,,,2023-05-31,2023-06-01,ACTUAL,2018-08-02,ACTUAL,2018-08-02,2023-05,2023-05-31,2022-08-24,ACTUAL,2022-08-24,2022-08-22,ACTUAL,2022-08-22,,INTERVENTIONAL,CheckMate 9UT,,A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder,"A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer",TERMINATED,,PHASE2,142.0,ACTUAL,Bristol-Myers Squibb,"As of early April 2021, Study CA2099UT enrollment was significantly behind the projected target enrollment, (number of participants enrolled 142; target enrollment 480). Since the study would be unable to meet the scientific objectives within a projected timeline, a decision was made in May 2021 to close the study.",4.0,,Insufficient Enrollment,f,,,,t,t,f,,,,,,,,,,,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,INDUSTRY,,,,,,,2022,0.0
NCT04352413,,2020-04-14,,,2024-03-05,2020-04-15,2020-04-20,ACTUAL,,,,,,,2024-03-05,2024-03-07,ACTUAL,2020-06-18,ACTUAL,2020-06-18,2020-04,2020-04-30,2022-04-29,ACTUAL,2022-04-29,2022-01-30,ACTUAL,2022-01-30,,INTERVENTIONAL,,,A Study of PLM60 in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy,"An Open-label, Multi-center, Phase 2 Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection (PLM60) in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy",TERMINATED,,PHASE2,45.0,ACTUAL,"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.",,2.0,,The sponsor has adjusted its R\&D strategy.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,INDUSTRY,,,,,,,2022,0.0
NCT02405910,,2015-03-24,,,2017-10-31,2015-03-27,2015-04-01,ESTIMATED,,,,,,,2017-10-31,2017-11-06,ACTUAL,2015-03-15,ESTIMATED,2015-03-15,2017-10,2017-10-31,2023-04,ESTIMATED,2023-04-30,2017-12,ESTIMATED,2017-12-31,,INTERVENTIONAL,,,Ph2 Nab-paclitaxel With Gemcitabine to Determine Efficacy in Advanced Non-squamous NSCLC.,A Phase II Randomized Study of Nab-paclitaxel With Gemcitabine at Two Different Dose Combinations to Determine Efficacy in Patients With Advanced Non- Squamous Non-small Cell Lung Cancer (NSCLC).,WITHDRAWN,,PHASE2,0.0,ACTUAL,West Virginia University,,2.0,,PI Left Institution,f,,,,t,,,,,,,,,,,,,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,OTHER,,,,,,,2023,0.0
NCT04383756,,2020-05-07,,,2022-02-21,2020-05-07,2020-05-12,ACTUAL,,,,,,,2022-02-21,2022-03-09,ACTUAL,2020-12,ESTIMATED,2020-12-31,2020-05,2020-05-31,2021-07,ESTIMATED,2021-07-31,2021-07,ESTIMATED,2021-07-31,,INTERVENTIONAL,,,Utilization of Donor Whole Blood for Blood Transfusion in Deceased Donor Liver Transplantation,Utilization of Donor Whole Blood for Blood Transfusion in Deceased Donor Liver Transplantation,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,Study was never started,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,OTHER,,,,,,,2021,0.0
NCT03035838,,2017-01-21,,,2022-10-31,2017-01-26,2017-01-30,ESTIMATED,,,,,,,2022-10-31,2022-11-03,ACTUAL,2021-11,ESTIMATED,2021-11-30,2022-10,2022-10-31,2023-04,ESTIMATED,2023-04-30,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,NK1,,Importance of Substance P in Intracranial Pressure Elevation Following Traumatic Brain Injury,Importance of Substance P in Intracranial Pressure Elevation Following Traumatic Brain Injury,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Cambridge,,1.0,,Alternate study commenced using different drug,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,OTHER,,,,,,,2023,0.0
NCT02448771,,2015-05-04,2021-05-06,,2022-10-21,2015-05-15,2015-05-19,ESTIMATED,2021-06-10,2021-07-01,ACTUAL,,,,2022-10-21,2022-10-24,ACTUAL,2015-07-09,ACTUAL,2015-07-09,2022-10,2022-10-31,2021-03-03,ACTUAL,2021-03-03,2019-08-12,ACTUAL,2019-08-12,,INTERVENTIONAL,,,A Study of Palbociclib in Combination With Bazedoxifene in Hormone Receptor Positive Breast Cancer,A Phase Ib/II Study of Palbociclib in Combination With Bazedoxifene in Hormone Receptor Positive Breast Cancer,COMPLETED,,PHASE1/PHASE2,36.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,OTHER,,,,,,,2021,1.0
NCT03796507,,2019-01-04,,,2021-04-06,2019-01-04,2019-01-08,ACTUAL,,,,,,,2021-04-06,2021-04-09,ACTUAL,2021-09-01,ESTIMATED,2021-09-01,2021-04,2021-04-30,2021-12-15,ESTIMATED,2021-12-15,2021-12-15,ESTIMATED,2021-12-15,,INTERVENTIONAL,,,Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation,Early Post-surgical Temozolomide Therapy in Patients With High-Grade Gliomas Admitted to Acute Rehabilitation: A Feasibility Study,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Rochester,,1.0,,Hiring freeze of research personnel due to COVID pandemic,f,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2021,0.0
NCT02524379,,2015-08-13,2022-05-12,,2022-06-07,2015-08-13,2015-08-14,ESTIMATED,2022-05-12,2022-06-07,ACTUAL,,,,2022-06-07,2022-07-05,ACTUAL,2017-02-14,ACTUAL,2017-02-14,2022-06,2022-06-30,2021-02-08,ACTUAL,2021-02-08,2021-02-08,ACTUAL,2021-02-08,,INTERVENTIONAL,SCING,,Spinal Cord Injury Neuroprotection With Glyburide,"Spinal Cord Injury Neuroprotection With Glyburide; Pilot Study: An Open-Label Prospective Evaluation of the Feasibility, Safety, Pharmacokinetics, and Preliminary Efficacy of Oral Glyburide (DiaBeta) in Patients With Acute Traumatic Spinal Cord Injury",TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,Ohio State University,,1.0,,Principal investigator has left the university; there were not enough participants to analyze the data.,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,OTHER,,,,,,,2021,0.0
NCT05116228,,2018-03-21,,,2021-11-02,2021-11-02,2021-11-10,ACTUAL,,,,,,,2021-11-02,2021-11-10,ACTUAL,2015-09-01,,2015-09-01,2021-11,2021-11-30,2021-11-01,ACTUAL,2021-11-01,2021-11-01,ACTUAL,2021-11-01,,INTERVENTIONAL,REDOREM,,Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis in Low Disease Activity and Remission,"Randomized, Prospective, Active-comparator Controlled, Patient-blinded Study to Demonstrate Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis Patients in Low Disease Activity and Remission - the REDOREM Study",TERMINATED,,PHASE4,21.0,ACTUAL,Medical University of Vienna,,2.0,,Failure to recruit,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,OTHER,,,,,,,2021,0.0
NCT04017013,,2019-06-19,,,2022-09-23,2019-07-09,2019-07-12,ACTUAL,,,,,,,2022-09-23,2022-09-26,ACTUAL,2020-03-01,ACTUAL,2020-03-01,2022-05,2022-05-31,2022-09-05,ACTUAL,2022-09-05,2022-09-05,ACTUAL,2022-09-05,,INTERVENTIONAL,,,Therapeutic Efficacy of Intravenous Lidocaine Infusion Compared With Epidural Analgesia for Postoperative Pain Control in Adult Patients Undergoing Major Abdominal Surgery: Non-Inferiority Clinical Trial,Therapeutic Efficacy of Intravenous Lidocaine Infusion Compared With Epidural Analgesia for Postoperative Pain Control in Adult Patients Undergoing Major Abdominal Surgery: Non-Inferiority Clinical Trial,COMPLETED,,PHASE4,210.0,ACTUAL,Universidad de Antioquia,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 14:06:05.777633,2024-10-16 14:06:05.777633,OTHER,,,,,,,2022,1.0
NCT04414241,,2020-06-01,,,2021-10-20,2020-06-01,2020-06-04,ACTUAL,,,,,,,2021-10-20,2021-10-28,ACTUAL,2020-06-25,ACTUAL,2020-06-25,2020-06,2020-06-30,2020-11-23,ACTUAL,2020-11-23,2020-11-23,ACTUAL,2020-11-23,,INTERVENTIONAL,,,Hydroxychloroquine to Prevent SARS-CoV-2 Infection/COVID-19,"Hydroxychloroquine to Prevent SARS-CoV-2 Infection Among Healthcare Workers: Randomized Controlled, Open-label, Phase 3 Clinical Trial",COMPLETED,,PHASE3,68.0,ACTUAL,Universidad Peruana Cayetano Heredia,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2020,0.0
NCT03305666,,2017-10-04,2021-07-08,,2021-09-02,2017-10-06,2017-10-10,ACTUAL,2021-08-02,2021-08-25,ACTUAL,,,,2021-09-02,2021-09-29,ACTUAL,2017-10-05,ACTUAL,2017-10-05,2021-09,2021-09-30,2021-01-31,ACTUAL,2021-01-31,2020-07-20,ACTUAL,2020-07-20,,INTERVENTIONAL,,The baseline analysis did not include two patients who were withdrawn from the study.,Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures,A Randomized Clinical Trial of Single Dose Liposomal Bupivacaine Delivered Via VATS Intercostal Nerve Block vs. Continuous Bupivacaine Infusion Delivered Via Indwelling Subscapular Catheter After Surgical Stabilization of Rib Fractures,COMPLETED,,PHASE4,36.0,ACTUAL,Denver Health and Hospital Authority,"There were no limitations that created barriers to the completion of this project. While this was expected at the outset of this exploratory trial, there was a relatively small sample size with a wide range of fractures for individual participants. Underpowering likely limited analyses of secondary outcomes such as narcotic requirements and failure of LRA. The study also excluded patients with GCS \< 8, so caution should be exercised when extrapolating to mechanically ventilated patients.",2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2021,1.0
NCT04874714,,2021-03-26,,,2023-12-13,2021-04-30,2021-05-06,ACTUAL,,,,,,,2023-12-13,2023-12-19,ACTUAL,2021-04-30,ACTUAL,2021-04-30,2023-12,2023-12-31,2023-10-09,ACTUAL,2023-10-09,2023-10-09,ACTUAL,2023-10-09,,INTERVENTIONAL,,,Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis,"Prospective, Randomized, Placebo-controlled, Multi-center Trial Comparing the Efficacy and Safety of Subcutaneous Immunotherapy With a Mixture of Grasses and Mites at Adequate Doses Versus Monotherapy, for the Treatment of Allergy",TERMINATED,,PHASE3,18.0,ACTUAL,Inmunotek S.L.,,4.0,,Due to the low recruitment rate since the start of the trial,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,INDUSTRY,,,,,,,2023,0.0
NCT03284463,,2017-09-14,,,2023-06-09,2017-09-14,2017-09-15,ACTUAL,,,,,,,2023-06-09,2023-06-12,ACTUAL,2018-01-01,ACTUAL,2018-01-01,2023-06,2023-06-30,2023-05-28,ACTUAL,2023-05-28,2022-08-28,ACTUAL,2022-08-28,,INTERVENTIONAL,SE-GRACE,,Safety and Efficacy of Glibenclamide Combined With Rt-PA in Acute Cerebral Embolism,"Safety and Efficacy of Glibenclamide Combined With Rt-PA in Treating Acute Ischemic Stroke: a Prospective, Randomized, Double-blind, Placebo-control, Multi-center Study",COMPLETED,,PHASE2/PHASE3,306.0,ACTUAL,"Nanfang Hospital, Southern Medical University",,2.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2023,0.0
NCT04073147,,2019-08-26,,,2022-01-18,2019-08-28,2019-08-29,ACTUAL,,,,,,,2022-01-18,2022-01-19,ACTUAL,2020-05-12,ACTUAL,2020-05-12,2022-01,2022-01-31,2021-11-25,ACTUAL,2021-11-25,2021-11-25,ACTUAL,2021-11-25,,INTERVENTIONAL,VENOBI-CNS,,Venetoclax and Obinutuzumab for Relapsed/Refractory Primary CNS Lymphoma,Chemotherapy Free Treatment With Venetoclax and Obinutuzumab for Relapsed / Refractory Primary CNS Lymphoma Patients (VENOBI-CNS Study) - A Phase IB Study to Assess the Pharmacokinetics in the Cerebrospinal Fluid,TERMINATED,,PHASE1,4.0,ACTUAL,Klinikum Stuttgart,,3.0,,low recruitment,f,,,,f,f,f,,,f,,,after study completion and publication of results.,not decided yet,,YES,IPD will by made available on a data depository (e.g. https://datadryad.org/) after study completion and publication of results.,2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,OTHER,,,,,,,2021,0.0
NCT03978884,,2019-06-05,,,2020-09-01,2019-06-06,2019-06-07,ACTUAL,,,,,,,2020-09-01,2020-09-03,ACTUAL,2019-06-01,ESTIMATED,2019-06-01,2019-05,2019-05-31,2020-12-31,ESTIMATED,2020-12-31,2020-05-31,ESTIMATED,2020-05-31,,INTERVENTIONAL,,,Phase 4 Study of the Efficacy of Losartan Based Therapy in Hypertensives With and Without Diabetes,"An Open Label, Single Arm Prospective Study to Evaluate Efficacy and Safety of Losartan Based Therapy Reslio® (Losartan) and Resilo-h® (Losartan+Hydrochlorthiazide) in Diabetic and Uncontrolled Hypertensive Patients",WITHDRAWN,,PHASE4,0.0,ACTUAL,The University of The West Indies,,4.0,,Unable to effective arrange trial logistics,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,OTHER,,,,,,,2020,0.0
NCT03500484,,2018-04-09,2023-03-09,,2024-07-12,2018-04-09,2018-04-18,ACTUAL,2024-07-12,2024-07-16,ACTUAL,,,,2024-07-12,2024-07-16,ACTUAL,2018-06-06,ACTUAL,2018-06-06,2024-07,2024-07-31,2020-06-25,ACTUAL,2020-06-25,2020-06-25,ACTUAL,2020-06-25,,INTERVENTIONAL,,,Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.,Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.,TERMINATED,,EARLY_PHASE1,13.0,ACTUAL,Yale University,,2.0,,"The study was initially paused due to COVID restrictions and then when able to resume, there was no longer funding.",f,,,,t,t,f,,,t,,,,,,,,2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,OTHER,,,,,,,2020,0.0
NCT03532009,,2018-03-29,2021-05-20,,2021-05-20,2018-05-09,2018-05-22,ACTUAL,2021-05-20,2021-06-15,ACTUAL,,,,2021-05-20,2021-06-15,ACTUAL,2018-06-26,ACTUAL,2018-06-26,2021-05,2021-05-31,2020-05-22,ACTUAL,2020-05-22,2020-05-22,ACTUAL,2020-05-22,,INTERVENTIONAL,PRIORITIZE HF,,Potassium Reduction Initiative to Optimize RAAS Inhibition Therapy With Sodium Zirconium Cyclosilicate in Heart Failure,"A Phase II, Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicentre, Three Month Duration Potassium Reduction Initiative to Optimize RAAS Inhibition Therapy With Sodium Zirconium Cyclosilicate in Heart Failure",TERMINATED,,PHASE2,182.0,ACTUAL,AstraZeneca,The study was paused from May to October 2019 to undergo a major protocol amendment. The study was also prematurely terminated due to the COVID-19 pandemic resulting in a reduced sample size and a high premature treatment discontinuation rate.,2.0,,Study stopped early due to the COVID-19 pandemic,,,,,t,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,INDUSTRY,,,,,,,2020,0.0
NCT04026464,,2019-07-16,,,2021-06-22,2019-07-18,2019-07-19,ACTUAL,,,,,,,2021-06-22,2021-06-24,ACTUAL,2021-04,ESTIMATED,2021-04-30,2021-06,2021-06-30,2021-05-12,ACTUAL,2021-05-12,2021-05-12,ACTUAL,2021-05-12,,INTERVENTIONAL,,,Addition of Acetaminophen in Standard PDA Management,Monotherapy (Ibuprofen) vs. Combination Therapy (Ibuprofen and Acetaminophen) in the Management of Patent Ductus Arteriosus in Premature Infants: A Randomized Controlled Trial,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Florida,,2.0,,Unable to obtain funding to support this project,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,OTHER,,,,,,,2021,0.0
NCT04771000,,2021-02-24,,,2023-03-17,2021-02-24,2021-02-25,ACTUAL,,,,,,,2023-03-17,2023-03-21,ACTUAL,2021-02-08,ACTUAL,2021-02-08,2023-03,2023-03-31,2023-02-27,ACTUAL,2023-02-27,2023-02-27,ACTUAL,2023-02-27,,INTERVENTIONAL,,,A Study of Micro Dose Ambrisentan in Hospitalized Patients With Respiratory Insufficiency Due to COVID-19,"A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Ambrisentan in Patients With Severe COVID-19",TERMINATED,,PHASE2,88.0,ACTUAL,Noorik Biopharmaceuticals AG,,2.0,,Lack of recruitment,f,,,,t,f,f,,,,,,,,,UNDECIDED,Not yet discussed or decided,2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,INDUSTRY,,,,,,,2023,0.0
NCT03224208,,2017-07-19,,,2021-04-23,2017-07-19,2017-07-21,ACTUAL,,,,,,,2021-04-23,2021-04-26,ACTUAL,2018-05-17,ACTUAL,2018-05-17,2021-04,2021-04-30,2021-01-08,ACTUAL,2021-01-08,2020-09-12,ACTUAL,2020-09-12,,INTERVENTIONAL,VECODUE,,Vemurafenib Plus Cobimetinib in Advanced or Metastatic Melanoma Patients,VECODUE A Phase II Trial of Vemurafenib Plus Cobimetinib in Patients Treated With Prior First-line Systemic Immunotherapy for Inoperable Locally Advanced or Metastatic Melanoma,TERMINATED,,PHASE2,9.0,ACTUAL,Fondazione Melanoma Onlus,,1.0,,low enrolment rate,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2021,0.0
NCT04590274,,2020-10-07,,,2021-12-05,2020-10-14,2020-10-19,ACTUAL,,,,,,,2021-12-05,2021-12-07,ACTUAL,2020-11,ESTIMATED,2020-11-30,2021-12,2021-12-31,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2),Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2),WITHDRAWN,,PHASE1,0.0,ACTUAL,International Brain Research Foundation,,1.0,,Investigative Team no longer interested,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2021,0.0
NCT04128007,,2019-10-14,2022-08-11,2021-06-18,2022-10-24,2019-10-14,2019-10-16,ACTUAL,2022-09-20,2022-09-30,ACTUAL,2022-09-20,2022-09-30,ACTUAL,2022-10-24,2022-10-26,ACTUAL,2020-01-13,ACTUAL,2020-01-13,2022-10,2022-10-31,2020-09-25,ACTUAL,2020-09-25,2020-09-23,ACTUAL,2020-09-23,,INTERVENTIONAL,,,Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis,"A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Adolescents and Adults With Scalp and Body Psoriasis",COMPLETED,,PHASE2,304.0,ACTUAL,"Arcutis Biotherapeutics, Inc.",,2.0,,,,,,,f,t,f,,,,,,,,,NO,,2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,INDUSTRY,,,,,,,2020,1.0
NCT03980483,,2019-05-15,2023-08-11,2022-08-05,2024-03-26,2019-06-07,2019-06-10,ACTUAL,2023-09-29,2023-10-25,ACTUAL,,2023-10-25,ACTUAL,2024-03-26,2024-03-27,ACTUAL,2019-05-16,ACTUAL,2019-05-16,2024-03,2024-03-31,2022-08-16,ACTUAL,2022-08-16,2021-09-15,ACTUAL,2021-09-15,,INTERVENTIONAL,contRAst 1,,Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate,"A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study Comparing GSK3196165 With Placebo and With Tofacitinib, in Combination With Methotrexate in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate",COMPLETED,,PHASE3,1537.0,ACTUAL,GlaxoSmithKline,,6.0,,,f,,,,t,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,INDUSTRY,,,,,,,2022,1.0
NCT04714619,,2020-12-02,,,2023-12-13,2021-01-15,2021-01-19,ACTUAL,,,,,,,2023-12-13,2023-12-19,ACTUAL,2021-05-06,ACTUAL,2021-05-06,2022-06,2022-06-30,2022-04-26,ACTUAL,2022-04-26,2021-09-02,ACTUAL,2021-09-02,,INTERVENTIONAL,CAILA,,CB-103 Plus NSAI In Luminal Advanced Breast Cancer,CB-103 Plus NSAI In Luminal Advanced Breast Cancer: CAILA Study,TERMINATED,,PHASE2,2.0,ACTUAL,MedSIR,,1.0,,Sponsor decision,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,OTHER,,,,,,,2022,0.0
NCT05346120,,2022-04-24,,,2023-12-05,2022-04-24,2022-04-26,ACTUAL,,,,,,,2023-12-05,2023-12-13,ACTUAL,2022-05-25,ESTIMATED,2022-05-25,2023-12,2023-12-31,2024-05-01,ESTIMATED,2024-05-01,2023-12-20,ESTIMATED,2023-12-20,,INTERVENTIONAL,COVID Long,,"Post-Acute COVID-19, Inflammation, and Depression","Post-Acute COVID-19, Inflammation, and Depression",WITHDRAWN,,PHASE2,0.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,Study never started,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2024,0.0
NCT03992196,,2019-06-17,2023-10-05,2023-08-29,2023-10-05,2019-06-17,2019-06-20,ACTUAL,2023-10-05,2023-10-30,ACTUAL,,2023-09-11,ACTUAL,2023-10-05,2023-10-30,ACTUAL,2019-12-03,ACTUAL,2019-12-03,2023-09,2023-09-30,2022-09-01,ACTUAL,2022-09-01,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,,"The Safety Set consisted of all participants who had at least one patch (rotigotine) applied. Due to data protection/data privacy, data cannot be reported for a single participant.",A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome,"A Remote, Open-Label, Long-Term, Follow-up Study to Determine the Safety, Tolerability, and Efficacy of Rotigotine Transdermal System as Monotherapy in Adolescents With Restless Legs Syndrome",TERMINATED,,PHASE3,10.0,ACTUAL,UCB Pharma,,1.0,,Sponsor decision; Not a safety decision,f,,,,f,t,f,,,f,,,"Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",http://clinicalstudydatarequest.com,YES,"Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.",2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,INDUSTRY,,,,,,,2022,0.0
NCT03504852,,2018-03-29,2021-05-11,2020-07-16,2021-10-07,2018-04-12,2018-04-20,ACTUAL,2021-05-11,2021-06-07,ACTUAL,2020-07-16,2020-07-20,ACTUAL,2021-10-07,2021-10-11,ACTUAL,2018-06-25,ACTUAL,2018-06-25,2021-10,2021-10-31,2020-07-15,ACTUAL,2020-07-15,2019-09-13,ACTUAL,2019-09-13,,INTERVENTIONAL,,,Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe Chronic Plaque Psoriasis,"A Randomized, Double-blind, Multicenter Study Assessing Short and Long-term Efficacy, Safety, and Tolerability of Sub-cutaneous Secukinumab in Subjects of Body Weight 90 kg or Higher With Moderate to Severe Chronic Plaque-type Psoriasis",COMPLETED,,PHASE3,331.0,ACTUAL,Novartis,,3.0,,,f,,,,f,t,f,,,,,,,,https://www.clinicalstudydatarequest.com/,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,INDUSTRY,,,,,,,2020,1.0
NCT04393506,,2020-05-03,,,2023-11-21,2020-05-16,2020-05-19,ACTUAL,,,,,,,2023-11-21,2023-11-22,ACTUAL,2020-04-23,ACTUAL,2020-04-23,2023-11,2023-11-30,2023-11-10,ACTUAL,2023-11-10,2020-11-02,ACTUAL,2020-11-02,,INTERVENTIONAL,,,Inductive Camrelizumab and Apatinib for Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma,Inductive Camrelizumab and Apatinib for Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma: A Single-arm Phase I Trial,COMPLETED,,PHASE1,21.0,ACTUAL,Shanghai Jiao Tong University School of Medicine,,1.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 14:11:52.931561,2024-10-16 14:11:52.931561,OTHER,,,,,,,2023,1.0
NCT03358875,,2017-11-27,,,2024-05-06,2017-11-27,2017-12-02,ACTUAL,,,,,,,2024-05-06,2024-05-07,ACTUAL,2017-11-30,ACTUAL,2017-11-30,2024-05,2024-05-31,2024-01-18,ACTUAL,2024-01-18,2020-08-10,ACTUAL,2020-08-10,,INTERVENTIONAL,,,Comparison of Efficacy and Safety of Anti-PD-1 Antibody BGB-A317 Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With NSCLC,"A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti-PD1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen",COMPLETED,,PHASE3,805.0,ACTUAL,BeiGene,,2.0,,,f,,,,t,f,f,,,,,,,,,YES,,2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,INDUSTRY,,,,,,,2024,1.0
NCT05227456,,2022-01-26,,,2024-05-22,2022-01-26,2022-02-07,ACTUAL,,,,,,,2024-05-22,2024-05-23,ACTUAL,2022-07-01,ACTUAL,2022-07-01,2024-05,2024-05-31,2024-04-30,ACTUAL,2024-04-30,2024-04-30,ACTUAL,2024-04-30,,INTERVENTIONAL,FEATS,,Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study,Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study,TERMINATED,,PHASE2,3.0,ACTUAL,Saskatchewan Health Authority - Regina Area,,1.0,,Difficulty in Recruitment,f,,,,f,t,t,,,t,,,,,,,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,OTHER,,,,,,,2024,0.0
NCT05470387,,2022-07-20,2024-04-01,,2024-05-17,2022-07-20,2022-07-22,ACTUAL,2024-05-17,2024-06-13,ACTUAL,,,,2024-05-17,2024-06-13,ACTUAL,2022-06-28,ACTUAL,2022-06-28,2024-04,2024-04-30,2023-08-11,ACTUAL,2023-08-11,2023-03-06,ACTUAL,2023-03-06,,INTERVENTIONAL,INTEGRITY,,A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection,"A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of LB1148 in Accelerating the Time to Return of Bowel Function in Subjects Undergoing Planned Bowel Resection (INTEGRITY)",TERMINATED,,PHASE3,23.0,ACTUAL,Palisade Bio,,2.0,,Company decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,INDUSTRY,,,,,,,2023,0.0
NCT05666349,,2022-11-02,,,2024-03-22,2022-12-23,2022-12-27,ACTUAL,,,,,,,2024-03-22,2024-03-26,ACTUAL,2023-10-13,ACTUAL,2023-10-13,2024-03,2024-03-31,2023-10-13,ACTUAL,2023-10-13,2023-10-13,ACTUAL,2023-10-13,,INTERVENTIONAL,RiNG,,Reirradiation and Niraparib in Patients With Recurrent Glioblastoma,Reirradiation (Re-RT) and Niraparib (NIRA) in Patients With Recurrent Glioblastoma (rGBM),WITHDRAWN,,PHASE1,0.0,ACTUAL,"University College, London",,1.0,,Funder support withdrawn 13-Oct-2023. Study did not open to recruitment.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,OTHER,,,,,,,2023,0.0
NCT05448677,,2022-06-27,,,2024-05-03,2022-07-04,2022-07-07,ACTUAL,,,,,,,2024-05-03,2024-05-06,ACTUAL,2022-12-15,ACTUAL,2022-12-15,2024-04,2024-04-30,2024-03-08,ACTUAL,2024-03-08,2024-03-08,ACTUAL,2024-03-08,,INTERVENTIONAL,ABE-LIVER,,Ezurpimtrostat Autophagy Inhibitor in Association With Atezolizumab-Bevacizumab in First Line Treatment of Unresectable Hepatocellular Carcinoma,"Ezurpimtrostat Autophagy Inhibitor in Association With Atezolizumab-Bevacizumab in First Line Treatment of Unresectable Hepatocellular Carcinoma, a Phase 2b Randomized Trial",TERMINATED,,PHASE2,3.0,ACTUAL,"University Hospital, Grenoble",,2.0,,Study terminated due to recruitement issues,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,OTHER,,,,,,,2024,0.0
NCT02343120,,2015-01-09,2022-03-30,,2022-04-26,2015-01-15,2015-01-21,ESTIMATED,2022-03-30,2022-04-27,ACTUAL,,,,2022-04-26,2022-04-28,ACTUAL,2014-09-04,ACTUAL,2014-09-04,2022-04,2022-04-30,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,,The Safety Analysis Set included all participants who received ≥ 1 dose of study drug,Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies,"A Phase I/II, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety and Pharmacokinetics of the BTK Inhibitor BGB-3111 in Subjects With B-Cell Lymphoid Malignancies",COMPLETED,,PHASE1/PHASE2,385.0,ACTUAL,BeiGene,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,INDUSTRY,,,,,,,2021,1.0
NCT03400306,,2018-01-12,,,2021-12-06,2018-01-12,2018-01-17,ACTUAL,,,,,,,2021-12-06,2021-12-08,ACTUAL,2021-11-15,ESTIMATED,2021-11-15,2021-12,2021-12-31,2021-11-16,ACTUAL,2021-11-16,2021-11-16,ACTUAL,2021-11-16,,INTERVENTIONAL,,,A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer,"A Phase 1, Single-Dose, Open-Label, Randomized Cross-Over Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer",WITHDRAWN,,PHASE1,0.0,ACTUAL,AbbVie,,3.0,,Strategic considerations,t,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,INDUSTRY,,NCT03123211,NO_LONGER_AVAILABLE,,,,2021,0.0
NCT03001557,,2016-11-16,2020-01-03,2019-07-22,2021-04-14,2016-12-20,2016-12-23,ESTIMATED,2020-01-03,2020-01-14,ACTUAL,2019-07-22,2019-07-29,ACTUAL,2021-04-14,2021-05-17,ACTUAL,2016-12-20,ACTUAL,2016-12-20,2021-04,2021-04-30,2020-04-17,ACTUAL,2020-04-17,2018-07-26,ACTUAL,2018-07-26,,INTERVENTIONAL,,The safety analysis set included the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose safety assessment.,Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Phase of the Efficacy and Safety of Lemborexant in Subjects With Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia",COMPLETED,,PHASE2,63.0,ACTUAL,Eisai Inc.,,5.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,INDUSTRY,,,,,,,2020,1.0
NCT05275400,,2022-03-03,,,2024-05-24,2022-03-03,2022-03-11,ACTUAL,,,,,,,2024-05-24,2024-05-28,ACTUAL,2022-03-08,ACTUAL,2022-03-08,2024-05,2024-05-31,2024-05-15,ACTUAL,2024-05-15,2024-05-15,ACTUAL,2024-05-15,,INTERVENTIONAL,,,A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin,"A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3)",COMPLETED,,PHASE3,986.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,INDUSTRY,,,,,,,2024,1.0
NCT04895410,,2021-05-19,,,2023-03-03,2021-05-19,2021-05-20,ACTUAL,,,,,,,2023-03-03,2023-03-06,ACTUAL,2022-01-17,ACTUAL,2022-01-17,2022-08,2022-08-31,2022-06-24,ACTUAL,2022-06-24,2022-06-24,ACTUAL,2022-06-24,,INTERVENTIONAL,,,Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Lemzoparlimab With or Without Oral/IV Dexamethasone and in Combination With Oral/IV/Subcutaneous Anti-Myeloma Regimens in Adult Participants With Multiple Myeloma,"A Phase 1b, Dose Escalation and Expansion Study of Lemzoparlimab With or Without Dexamethasone and in Combination With Anti-Myeloma Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma",TERMINATED,,PHASE1,8.0,ACTUAL,AbbVie,,9.0,,Strategic considerations,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,INDUSTRY,,,,,,,2022,0.0
NCT04826588,,2021-03-31,,,2023-02-20,2021-03-31,2021-04-01,ACTUAL,,,,,,,2023-02-20,2023-02-22,ACTUAL,2021-05-23,ACTUAL,2021-05-23,2023-02,2023-02-28,2022-11-20,ACTUAL,2022-11-20,2022-11-20,ACTUAL,2022-11-20,,INTERVENTIONAL,,,Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY),Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY),COMPLETED,,PHASE3,76.0,ACTUAL,University Children's Hospital Basel,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,OTHER,,,,,,,2022,1.0
NCT04099888,,2019-07-26,2022-10-26,,2023-08-15,2019-09-20,2019-09-23,ACTUAL,2023-08-15,2023-09-11,ACTUAL,,,,2023-08-15,2023-09-11,ACTUAL,2019-05-23,ACTUAL,2019-05-23,2023-04,2023-04-30,2022-05-06,ACTUAL,2022-05-06,2022-04-28,ACTUAL,2022-04-28,,INTERVENTIONAL,RELEASE,Intent-to-treat (ITT) Analysis Set,PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer,"A Multi-Center Randomised Open-Label Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Fimaporfin-Induced Photochemical Internalisation of Gemcitabine Complemented by Gemcitabine/Cisplatin Chemotherapy Versus Gemcitabine/Cisplatin Alone in Patients With Inoperable Cholangiocarcinoma",TERMINATED,,PHASE2,41.0,ACTUAL,PCI Biotech AS,"Due to the early termination of this study, no definitive conclusions can be drawn since an insufficient number of participants was recruited. A reduced statistical analysis was conducted.",2.0,,"Recent results from a Phase 3 study are expected to change the standard of care for patients with inoperable CCA, rendering the RELEASE study challenging to complete and potentially inadequate for NDA approval.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,INDUSTRY,,,,,,,2022,0.0
NCT03335371,,2017-10-31,2022-11-23,2020-11-24,2023-06-12,2017-11-03,2017-11-07,ACTUAL,2023-06-12,2023-07-03,ACTUAL,,2023-07-03,ACTUAL,2023-06-12,2023-07-03,ACTUAL,2017-10-25,ACTUAL,2017-10-25,2023-06,2023-06-30,2020-01-06,ACTUAL,2020-01-06,2019-12-20,ACTUAL,2019-12-20,,INTERVENTIONAL,SimpliciT1,Sentinel participants were the same participants throughout the dose levels. Part 1 is the full analysis set. Part 2 is all randomized subjects who received at least 1 dose of the investigational product.,Evaluation of TTP399 in Patients With Type 1 Diabetes,"A Multi-Center, Randomized, Double-Blind, Parallel-Group, Multiple-Dose, Adaptive Study Assessing the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of TTP399 in With Adult Patients Type 1 Diabetes Mellitus",COMPLETED,,PHASE1/PHASE2,115.0,ACTUAL,vTv Therapeutics,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,INDUSTRY,,,,,,,2020,1.0
NCT04564846,,2020-09-21,2024-02-20,,2024-04-10,2020-09-21,2020-09-25,ACTUAL,2024-04-10,2024-05-07,ACTUAL,,,,2024-04-10,2024-05-07,ACTUAL,2020-11-23,ACTUAL,2020-11-23,2024-04,2024-04-30,2022-06-07,ACTUAL,2022-06-07,2022-06-07,ACTUAL,2022-06-07,,INTERVENTIONAL,,,A Study to Evaluate the Effect of ORMD-0801 in Patients With Type 2 Diabetes Mellitus,"A Randomized, Double Blind, Phase 2b Study to Evaluate the Effect of ORMD-0801 Compared to Placebo on Endogenous Glucose Production in Patients With Type 2 Diabetes Mellitus",COMPLETED,,PHASE2,49.0,ACTUAL,"Oramed, Ltd.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 03:18:23.932326,2024-10-15 03:18:23.932326,INDUSTRY,,,,,,,2022,1.0
NCT04551885,,2020-09-09,,,2023-09-19,2020-09-15,2020-09-16,ACTUAL,,,,,,,2023-09-19,2023-09-21,ACTUAL,2020-09-07,ACTUAL,2020-09-07,2023-09,2023-09-30,2023-08-11,ACTUAL,2023-08-11,2023-08-11,ACTUAL,2023-08-11,,INTERVENTIONAL,,,FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors,"A Phase I, Open-Label, Multicenter Study of FT516 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,12.0,ACTUAL,Fate Therapeutics,,1.0,,This study was terminated by the Sponsor.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,INDUSTRY,,,,,,,2023,0.0
NCT02422290,,2015-04-13,2020-01-24,,2020-08-14,2015-04-16,2015-04-21,ESTIMATED,2020-08-14,2020-08-17,ACTUAL,,,,2020-08-14,2020-08-17,ACTUAL,2015-03,ACTUAL,2015-03-31,2020-08,2020-08-31,2020-07-31,ACTUAL,2020-07-31,2018-02-21,ACTUAL,2018-02-21,,INTERVENTIONAL,,,Ketamine Treatment for Pediatric-Refractory Obsessive-Compulsive Disorder (OCD),Ketamine Treatment for Pediatric-Refractory Obsessive-Compulsive Disorder (OCD),COMPLETED,,PHASE1/PHASE2,5.0,ACTUAL,New York State Psychiatric Institute,,1.0,,,f,,,,f,,,,,,,,,,,NO,,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,OTHER,,,,,,,2020,1.0
NCT00630565,,2008-03-06,2023-08-15,,2024-01-09,2008-03-06,2008-03-07,ESTIMATED,2024-01-09,2024-01-29,ACTUAL,,,,2024-01-09,2024-01-29,ACTUAL,2006-07-26,ACTUAL,2006-07-26,2024-01,2024-01-31,2022-07-28,ACTUAL,2022-07-28,2022-07-28,ACTUAL,2022-07-28,,INTERVENTIONAL,,No participants enrolled under the age of 2 years old.,Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia,Autologous Peripheral Blood Stem Cell Transplant for Acute Non-Lymphocytic Leukemia (ANLL),TERMINATED,,PHASE2/PHASE3,12.0,ACTUAL,"Masonic Cancer Center, University of Minnesota",,2.0,,Slow Accrual,f,,,,t,,f,,,,,,,,,,,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,OTHER,,,,,,,2022,0.0
NCT02576509,,2015-10-13,2020-05-29,,2024-03-15,2015-10-14,2015-10-15,ESTIMATED,2020-06-24,2020-06-26,ACTUAL,,,,2024-03-15,2024-03-19,ACTUAL,2015-12-07,ACTUAL,2015-12-07,2024-03,2024-03-31,2024-02-07,ACTUAL,2024-02-07,2019-05-30,ACTUAL,2019-05-30,,INTERVENTIONAL,,,An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma,"A Randomized, Multi-center Phase III Study of Nivolumab Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (CheckMate 459: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 459)",COMPLETED,,PHASE3,743.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,INDUSTRY,,,,,,,2024,1.0
NCT04782609,,2021-02-19,,,2022-11-14,2021-03-01,2021-03-04,ACTUAL,,,,,,,2022-11-14,2022-11-17,ACTUAL,2021-12-27,ACTUAL,2021-12-27,2022-11,2022-11-30,2022-11-04,ACTUAL,2022-11-04,2022-11-04,ACTUAL,2022-11-04,,INTERVENTIONAL,Glio,,Study of Icapamespib (PU-AD) in Patients With Recurrent Malignant Glioma,A Phase 1b Dose Escalation/Dose Expansion Study of Icapamespib (PU-AD) in Patients With Recurrent Malignant Glioma,TERMINATED,,PHASE1,7.0,ACTUAL,"Samus Therapeutics, Inc.",,2.0,,Samus Therapeutics Company Closure,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,INDUSTRY,,,,,,,2022,0.0
NCT04770532,,2021-02-22,,2023-01-23,2023-05-12,2021-02-22,2021-02-25,ACTUAL,,,,2023-01-23,2023-01-26,ACTUAL,2023-05-12,2023-05-15,ACTUAL,2021-03-05,ACTUAL,2021-03-05,2023-05,2023-05-31,2022-03-01,ACTUAL,2022-03-01,2022-01-27,ACTUAL,2022-01-27,,INTERVENTIONAL,ONWARDS 2,,"A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin","A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec, Both With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes Treated With Basal Insulin",COMPLETED,,PHASE3,526.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,INDUSTRY,,,,,,,2022,1.0
NCT04871737,,2021-04-21,,,2023-07-24,2021-04-30,2021-05-04,ACTUAL,,,,,,,2023-07-24,2023-07-25,ACTUAL,2021-05-20,ACTUAL,2021-05-20,2023-07,2023-07-31,2022-09-30,ACTUAL,2022-09-30,2022-08-21,ACTUAL,2022-08-21,,INTERVENTIONAL,,,Study of a Live rNDV Based Vaccine Against COVID-19,"Dose-escalation, Open-label, Non-randomized Phase I Study to Evaluate the Safety and Immunogenicity of Three Concentrations of a rNDV Vaccine Against SARS-CoV-2 Administered by the Intranasal and Intramuscular Route to Healthy Volunteers",COMPLETED,,PHASE1,91.0,ACTUAL,"Laboratorio Avi-Mex, S.A. de C.V.",,10.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,INDUSTRY,,,,,,,2022,1.0
NCT04349072,,2020-04-07,2023-02-07,,2024-06-27,2020-04-15,2020-04-16,ACTUAL,2023-02-07,2023-03-07,ACTUAL,,,,2024-06-27,2024-07-11,ACTUAL,2020-07-06,ACTUAL,2020-07-06,2024-06,2024-06-30,2024-05-20,ACTUAL,2024-05-20,2022-02-07,ACTUAL,2022-02-07,,INTERVENTIONAL,VALOR-HCM,,A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy,"A Randomized, Double-blind, Placebo-controlled Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Who Are Eligible for Septal Reduction Therapy",COMPLETED,,PHASE3,112.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,INDUSTRY,,,,,,,2024,1.0
NCT04504734,,2020-08-04,,,2023-07-05,2020-08-06,2020-08-07,ACTUAL,,,,,,,2023-07-05,2023-07-07,ACTUAL,2020-11-27,ACTUAL,2020-11-27,2023-07,2023-07-31,2023-06-12,ACTUAL,2023-06-12,2023-06-12,ACTUAL,2023-06-12,,INTERVENTIONAL,,,Bucillamine in Treatment of Patients With COVID-19,"Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients With Mild-Moderate COVID-19",TERMINATED,,PHASE3,713.0,ACTUAL,"Revive Therapeutics, Ltd.",,3.0,,Met definition of futility according to DSMB,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,INDUSTRY,,,,,,,2023,0.0
NCT04000009,,2019-06-25,2022-02-16,,2022-03-31,2019-06-25,2019-06-27,ACTUAL,2022-03-31,2022-04-05,ACTUAL,,,,2022-03-31,2022-04-05,ACTUAL,2019-06-06,ACTUAL,2019-06-06,2022-03,2022-03-31,2021-02-22,ACTUAL,2021-02-22,2021-02-22,ACTUAL,2021-02-22,,INTERVENTIONAL,,All patients enrolled who received at least one dose of study medication,Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment,A 52-Week Open-Label Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment,TERMINATED,,PHASE3,235.0,ACTUAL,ACADIA Pharmaceuticals Inc.,This study was terminated early by the Sponsor for business reasons due to the COVID-19 pandemic; there were no safety concerns contributing to study termination. Patients were discontinued from the study and completed safety follow-up procedures.,1.0,,The study was terminated for business reasons and not due to safety concerns.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,INDUSTRY,,,,,,,2021,0.0
NCT04604184,,2020-10-26,2022-03-22,,2022-04-07,2020-10-26,2020-10-27,ACTUAL,2022-04-07,2022-04-11,ACTUAL,,,,2022-04-07,2022-04-11,ACTUAL,2020-11-03,ACTUAL,2020-11-03,2022-04,2022-04-30,2021-05-31,ACTUAL,2021-05-31,2021-03-24,ACTUAL,2021-03-24,,INTERVENTIONAL,,"Full Analysis Set (FAS): FAS included all patients (pts) in randomized set (RS) who received at least 1 dose of trial drug, comprised 129 pts (85.4%). Of all pts randomised, number (%) of pts not treated was similar in BI 764198 (2/67 pts \[3.0%\]) and placebo group (2/66 pts \[3.0%\]). The 4 pts excluded from FAS discontinued trial before receiving treatment for following reasons: pt's withdrawal (n=2), meeting an exclusion criterion (n=1), and clinical worsening (n=1).",ACTION ON COVID-19: A Study to Test Whether BI 764198 Helps Lung Health of People Hospitalised With COVID-19,BI 764198 Efficacy and Safety in Prevention/Progression of ARDS and ARDS-related Complications Secondary to COVID-19 (ACTION ON COVID-19),TERMINATED,,PHASE2,133.0,ACTUAL,Boehringer Ingelheim,This trial was terminated early following the recommendation of a Data Monitoring Committee.,2.0,,Company decision,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,INDUSTRY,,,,,,,2021,0.0
NCT05445128,,2022-05-26,,,2024-01-09,2022-07-05,2022-07-06,ACTUAL,,,,,,,2024-01-09,2024-01-11,ACTUAL,2022-06-24,ACTUAL,2022-06-24,2024-01,2024-01-31,2023-02-02,ACTUAL,2023-02-02,2022-12-08,ACTUAL,2022-12-08,,INTERVENTIONAL,,,Study of MGTA-145 and Plerixafor in Patients With Sickle Cell Disease,"A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of MGTA-145 in Combination With Plerixafor for the Mobilization of Hematopoietic Stem Cells in Patients With Sickle Cell Disease",TERMINATED,,PHASE2,1.0,ACTUAL,Ensoma,,2.0,,"This study was voluntarily terminated due to a business decision not to proceed, and not due to any safety issue.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,INDUSTRY,,,,,,,2023,0.0
NCT04085575,,2019-08-29,,,2020-07-13,2019-09-10,2019-09-11,ACTUAL,,,,,,,2020-07-13,2020-07-14,ACTUAL,2019-01-01,ACTUAL,2019-01-01,2019-09,2019-09-30,2020-01-09,ACTUAL,2020-01-09,2019-12-09,ACTUAL,2019-12-09,,INTERVENTIONAL,,,Efficacy of Intra-auricular Tranexamic Acid in Total Knee Arthroplasty,Efficacy of 1g Versus 2g Intra-auricular Tranexamic Acid in Postoperative Bleeding After Total Knee Arthroplasty,COMPLETED,,PHASE4,100.0,ACTUAL,Centre Hospitalier de Montauban,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,The aim of our study was to observe postoperative bleeding with combined intravenous and per - os administration with two intra - articular doses (1 g and 2 g) of tranexamic acid.,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,OTHER,,,,,,,2020,0.0
NCT02564263,,2015-09-29,2019-09-26,,2023-02-09,2015-09-29,2015-09-30,ESTIMATED,2019-11-01,2019-11-20,ACTUAL,,,,2023-02-09,2023-03-13,ACTUAL,2015-12-01,ACTUAL,2015-12-01,2023-02,2023-02-28,2022-03-14,ACTUAL,2022-03-14,2018-10-15,ACTUAL,2018-10-15,,INTERVENTIONAL,,,Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181),"A Phase III Randomized Open-Label Study of Single Agent Pembrolizumab vs Physicians' Choice of Single Agent Docetaxel, Paclitaxel, or Irinotecan in Subjects With Advanced/Metastatic Adenocarcinoma and Squamous Cell Carcinoma of the Esophagus That Have Progressed After First-Line Standard Therapy (KEYNOTE-181)",COMPLETED,,PHASE3,628.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 14:17:47.921169,2024-10-16 14:17:47.921169,INDUSTRY,,,,,,,2022,1.0
NCT03481894,,2015-12-03,,,2019-09-02,2018-03-22,2018-03-29,ACTUAL,,,,,,,2019-09-02,2019-09-04,ACTUAL,2018-03,ESTIMATED,2018-03-31,2019-09,2019-09-30,2021-03,ESTIMATED,2021-03-31,2020-03,ESTIMATED,2020-03-31,,INTERVENTIONAL,,,Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age,"Prospective, Randomized, Open-Label, Parallel-Group, Active-Controlled, Multicenter Study to Assess Safe and Effective Doses of Kabiven® in Pediatric Patients 2 to 16 Years of Age",WITHDRAWN,,PHASE4,0.0,ACTUAL,Fresenius Kabi,,2.0,,FDA released Fresenius Kabi from this post marketing requirement on 07/16/2019.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,INDUSTRY,,,,,,,2021,0.0
NCT04172363,,2019-11-15,,,2022-10-25,2019-11-19,2019-11-21,ACTUAL,,,,,,,2022-10-25,2022-10-27,ACTUAL,2020-07-22,ESTIMATED,2020-07-22,2022-10,2022-10-31,2021-05-22,ESTIMATED,2021-05-22,2021-05-22,ESTIMATED,2021-05-22,,INTERVENTIONAL,AntiSeptic,,Clinical Relevance of the Antimicrobial Resistance Testing in the Treatment of Chronic Wounds With Antiseptics,Clinical Relevance of the Antimicrobial Resistance Testing in the Treatment of Chronic Wounds With Antiseptics,WITHDRAWN,,PHASE3,0.0,ACTUAL,RWTH Aachen University,,2.0,,PI left site,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,OTHER,,,,,,,2021,0.0
NCT04193566,,2019-12-03,,,2021-01-29,2019-12-06,2019-12-10,ACTUAL,,,,,,,2021-01-29,2021-02-03,ACTUAL,2020-02-01,ACTUAL,2020-02-01,2021-01,2021-01-31,2021-01-01,ACTUAL,2021-01-01,2020-09-01,ACTUAL,2020-09-01,,INTERVENTIONAL,Astronaut,,Acute Effects of SGLT2 Inhibition on Renal Oxygenation and Autonomic Function in Type 1 Diabetes,Acute Effects of Sodium-glucose Cotransporter-2 Inhibition on Renal Oxygenation and Autonomic Function in Type 1 Diabetes,COMPLETED,,PHASE4,30.0,ACTUAL,Steno Diabetes Center Copenhagen,,2.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,OTHER,,,,,,,2021,1.0
NCT03040999,,2017-02-01,2023-05-12,,2024-08-28,2017-02-01,2017-02-02,ESTIMATED,2023-05-12,2023-06-08,ACTUAL,,,,2024-08-28,2024-09-19,ACTUAL,2017-04-05,ACTUAL,2017-04-05,2024-08,2024-08-31,2024-08-21,ACTUAL,2024-08-21,2022-05-31,ACTUAL,2022-05-31,,INTERVENTIONAL,,,Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412),A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412),COMPLETED,,PHASE3,804.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,INDUSTRY,,,,,,,2024,1.0
NCT03973177,,2019-05-28,,,2022-04-20,2019-06-03,2019-06-04,ACTUAL,,,,,,,2022-04-20,2022-04-28,ACTUAL,2019-05-24,ACTUAL,2019-05-24,2022-04,2022-04-30,2023-03,ESTIMATED,2023-03-31,2022-07,ESTIMATED,2022-07-31,,INTERVENTIONAL,,,Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain,"Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain Following Total Knee Arthroplasty: a Pilot Prospective, Randomized, Crossover Trial",WITHDRAWN,,PHASE4,0.0,ACTUAL,Northwestern University,,2.0,,Covid restrictions on recruitment,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,OTHER,,,,,,,2023,0.0
NCT04615949,,2020-11-02,,,2022-12-12,2020-11-03,2020-11-04,ACTUAL,,,,,,,2022-12-12,2022-12-14,ACTUAL,2021-04-30,ACTUAL,2021-04-30,2022-10,2022-10-31,2022-11-30,ACTUAL,2022-11-30,2022-11-30,ACTUAL,2022-11-30,,INTERVENTIONAL,,,Cannabidiol in Patients With COVID-19 and Cardiovascular Disease or Risk Factors,"Study to Evaluate the Efficacy and Safety of CardiolRx™ in Patients With COVID-19 and Cardiovascular Disease or Risk Factors A Double-blind, Placebo-controlled Trial",TERMINATED,,PHASE2/PHASE3,90.0,ACTUAL,Cardiol Therapeutics Inc.,,2.0,,"The changing nature of COVID-19 including a more vaccinated population, increasing natural population immunity, milder variants and other related factors has meant that it is no longer realistic to recruit the patients in a reasonable time frame.",,,,,t,t,f,,,,,,Data will become available in Q4 2022,Access to the journal in which article has been published,,YES,The data will become available once the study has been published,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,INDUSTRY,,,,,,,2022,0.0
NCT02927847,,2016-10-06,2022-05-26,,2022-06-22,2016-10-06,2016-10-07,ESTIMATED,2022-06-22,2022-06-28,ACTUAL,,,,2022-06-22,2022-06-28,ACTUAL,2017-02-01,ACTUAL,2017-02-01,2022-06,2022-06-30,2022-05-27,ACTUAL,2022-05-27,2021-05-28,ACTUAL,2021-05-28,,INTERVENTIONAL,,,"Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation",Targeting Reward Dysfunction as a Mechanism to Improve Smoking Cessation,COMPLETED,,PHASE1/PHASE2,35.0,ACTUAL,Duke University,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,OTHER,,,,,,,2022,1.0
NCT03253796,,2017-08-16,2022-03-04,,2023-07-25,2017-08-16,2017-08-18,ACTUAL,2022-04-06,2022-05-04,ACTUAL,,,,2023-07-25,2023-07-28,ACTUAL,2017-11-07,ACTUAL,2017-11-07,2023-07,2023-07-31,2021-03-17,ACTUAL,2021-03-17,2021-03-17,ACTUAL,2021-03-17,,INTERVENTIONAL,,,Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (GO-BACK) (MK-8259-038),"A Phase-IV, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of Golimumab (MK-8259 [SCH 900259]) After Treatment Withdrawal, Compared With Continued Treatment (Either Full- or Reduced-Treatment Regimen), In Subjects With Non-Radiographic Axial Spondyloarthritis",COMPLETED,,PHASE4,323.0,ACTUAL,Merck Sharp & Dohme LLC,,4.0,,,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,INDUSTRY,,,,,,,2021,1.0
NCT02570503,,2015-10-05,2022-02-08,,2022-03-02,2015-10-05,2015-10-07,ESTIMATED,2022-03-02,2022-03-04,ACTUAL,,,,2022-03-02,2022-03-04,ACTUAL,2015-10,,2015-10-31,2022-03,2022-03-31,2021-02-11,ACTUAL,2021-02-11,2021-02-11,ACTUAL,2021-02-11,,INTERVENTIONAL,,,Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty,"Do Intraoperative Periarticular Injections Improve Postoperative Pain Control in Patients Receiving Duramorph (Preservative Free) During Total Knee Arthroplasty? A Prospective, Double-Blind, Randomized Controlled Trial",TERMINATED,,PHASE4,64.0,ACTUAL,Virginia Commonwealth University,,2.0,,"Study's primary aims are no longer clinically impactful, as intrathecal morphine has fallen out of favor and replaced with different agents so that outpatient/23 hr surgery is more predictably achievable.",f,,,,t,,,,,,,,,,,NO,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,OTHER,,,,,,,2021,0.0
NCT04387448,,2020-05-11,,,2022-11-10,2020-05-11,2020-05-13,ACTUAL,,,,,,,2022-11-10,2022-11-15,ACTUAL,2020-07-28,ACTUAL,2020-07-28,2022-11,2022-11-30,2022-11-01,ACTUAL,2022-11-01,2022-11-01,ACTUAL,2022-11-01,,INTERVENTIONAL,,,"A Study of TRPC5 Channel Inhibitor in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease","A Phase 2a Multiple Ascending, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GFB-887, a TRPC5 Channel Inhibitor, in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease",TERMINATED,,PHASE2,96.0,ACTUAL,"Goldfinch Bio, Inc.",,2.0,,Business reasons,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,INDUSTRY,,,,,,,2022,0.0
NCT04044430,,2019-08-01,,,2023-01-05,2019-08-01,2019-08-05,ACTUAL,,,,,,,2023-01-05,2023-01-09,ACTUAL,2020-08-31,ACTUAL,2020-08-31,2023-01,2023-01-31,2022-07-31,ACTUAL,2022-07-31,2022-07-31,ACTUAL,2022-07-31,,INTERVENTIONAL,,,"Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer","Phase I/II Trial of Encorafenib, Binimetinib, and Nivolumab in Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer",TERMINATED,,PHASE1,2.0,ACTUAL,"University of California, San Francisco",,1.0,,Sponsor funding,,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,OTHER,,,,,,,2022,0.0
NCT03197064,,2017-06-20,2022-06-16,2021-02-09,2022-07-13,2017-06-21,2017-06-23,ACTUAL,2022-07-13,2022-07-18,ACTUAL,2021-02-09,2021-02-11,ACTUAL,2022-07-13,2022-07-18,ACTUAL,2018-01-01,ACTUAL,2018-01-01,2022-07,2022-07-31,2020-01-31,ACTUAL,2020-01-31,2020-01-31,ACTUAL,2020-01-31,,INTERVENTIONAL,,,Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked Potentials Under General Anesthesia,Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked Potentials Under General Anesthesia,COMPLETED,,PHASE4,11.0,ACTUAL,Stanford University,,1.0,,,f,,,,t,t,f,,,t,,,,,,YES,There is a plan to make IPD available only to members of the research team involved in this project. All patient identifying information will be removed from all data as it is collected to protect patient privacy.,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,OTHER,,,,,,,2020,1.0
NCT00948675,,2009-07-28,2014-01-14,,2021-10-18,2009-07-28,2009-07-29,ESTIMATED,2014-03-04,2014-04-02,ESTIMATED,,,,2021-10-18,2021-10-29,ACTUAL,2009-09-01,ACTUAL,2009-09-01,2021-10,2021-10-31,2020-11-06,ACTUAL,2020-11-06,2013-01-31,ACTUAL,2013-01-31,,INTERVENTIONAL,,All randomized participants.,Study of Participants With Advanced Non-Small Cell Lung Cancer,A Study of Pemetrexed Plus Carboplatin Followed by Maintenance Pemetrexed vs Paclitaxel Plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients With Advanced NCSLC of Nonsquamous Histology,COMPLETED,,PHASE3,361.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,,,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,INDUSTRY,,,,,,,2020,1.0
NCT03316729,,2017-10-17,,,2018-12-20,2017-10-19,2017-10-20,ACTUAL,,,,,,,2018-12-20,2018-12-24,ACTUAL,2018-01,ESTIMATED,2018-01-31,2017-11,2017-11-30,2020-02,ESTIMATED,2020-02-29,2020-02,ESTIMATED,2020-02-29,,INTERVENTIONAL,,,DS-9231 in Intermediate-risk (Sub-massive) Acute Pulmonary Embolism (PE),Evaluation of Safety and Thrombolytic Effect of Ascending Doses of DS-9231 (TS23) in Subjects With Intermediate-risk (Sub-massive) Acute Pulmonary Embolism (PE),WITHDRAWN,,PHASE2,0.0,ACTUAL,Daiichi Sankyo,,2.0,,Product development cancelled.,f,,,,t,t,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,INDUSTRY,,,,,,,2020,0.0
NCT05760703,,2023-02-23,,,2023-12-13,2023-03-06,2023-03-08,ACTUAL,,,,,,,2023-12-13,2023-12-19,ACTUAL,2023-04-25,ACTUAL,2023-04-25,2023-12,2023-12-31,2023-12-11,ACTUAL,2023-12-11,2023-12-11,ACTUAL,2023-12-11,,INTERVENTIONAL,,,Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B,"Phase Ib/II: Multicenter, Open, Dose-escalation Evaluation of the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B Treated With Oral Antiviral Therapy(Long-term Follow-up)",TERMINATED,,PHASE2,9.0,ACTUAL,"Staidson (Beijing) Biopharmaceuticals Co., Ltd",,4.0,,"The preliminary effectiveness data observed at present did not meet the expectations, the benefit of the subjects receiving the experimental drug was limited.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,INDUSTRY,,,,,,,2023,0.0
NCT03552757,,2018-05-30,2021-06-16,2021-03-11,2021-11-08,2018-05-30,2018-06-12,ACTUAL,2021-07-20,2021-08-11,ACTUAL,2021-07-20,2021-08-11,ACTUAL,2021-11-08,2021-11-09,ACTUAL,2018-06-04,ACTUAL,2018-06-04,2021-11,2021-11-30,2020-05-01,ACTUAL,2020-05-01,2020-03-24,ACTUAL,2020-03-24,,INTERVENTIONAL,STEP 2,Full analysis set (FAS) which comprised all randomised participants.,Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity,Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity and Type 2 Diabetes,COMPLETED,,PHASE3,1210.0,ACTUAL,Novo Nordisk A/S,,3.0,,,f,,,,f,t,f,,,,,,,,http://www.novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,INDUSTRY,,,,,,,2020,1.0
NCT04000529,,2019-06-24,,,2024-01-19,2019-06-26,2019-06-27,ACTUAL,,,,,,,2024-01-19,2024-01-22,ACTUAL,2019-07-30,ACTUAL,2019-07-30,2024-01,2024-01-31,2024-01-15,ACTUAL,2024-01-15,2024-01-15,ACTUAL,2024-01-15,,INTERVENTIONAL,,,Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies,"A Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies",TERMINATED,,PHASE1,122.0,ACTUAL,Novartis,,2.0,,Business reasons,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,INDUSTRY,,,,,,,2024,0.0
NCT03997448,,2019-06-24,2023-10-25,,2024-02-15,2019-06-24,2019-06-25,ACTUAL,2024-02-15,2024-02-20,ACTUAL,,,,2024-02-15,2024-02-20,ACTUAL,2019-08-26,ACTUAL,2019-08-26,2024-02,2024-02-29,2020-01-30,ACTUAL,2020-01-30,2020-01-30,ACTUAL,2020-01-30,,INTERVENTIONAL,,,Abemaciclib and Pembrolizumab in Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma: Big Ten Cancer Research Consortium BTCRC-GI18-149,Phase II Study of the Combination of Abemaciclib and Pembrolizumab in Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma: Big Ten Cancer Research Consortium BTCRC-GI18-149,TERMINATED,,PHASE2,3.0,ACTUAL,Big Ten Cancer Research Consortium,,1.0,,Funder decision,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,OTHER,,,,,,,2020,0.0
NCT01682083,,2012-09-06,2018-05-29,2018-03-30,2023-08-16,2012-09-07,2012-09-10,ESTIMATED,2018-08-28,2018-09-26,ACTUAL,2018-03-30,2018-04-03,ACTUAL,2023-08-16,2023-08-30,ACTUAL,2013-01-08,ACTUAL,2013-01-08,2023-08,2023-08-31,2023-07-31,ACTUAL,2023-07-31,2017-06-30,ACTUAL,2017-06-30,,INTERVENTIONAL,COMBI-AD,The Intent-to-Treat Population (ITT) consisted of all randomized patients whether or not randomized treatment was administered.,Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).,COMBI-AD: A Phase III Randomized Double Blind Study of Dabrafenib (GSK2118436) in COMBInation With Trametinib (GSK1120212) Versus Two Placebos in the ADjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection,COMPLETED,,PHASE3,870.0,ACTUAL,Novartis,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,INDUSTRY,,,,,,,2023,1.0
NCT04663126,,2020-11-30,,,2023-12-05,2020-12-03,2020-12-10,ACTUAL,,,,,,,2023-12-05,2023-12-13,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2023-12,2023-12-31,2023-06-19,ACTUAL,2023-06-19,2023-01-08,ACTUAL,2023-01-08,,INTERVENTIONAL,Tilmanocept,,Feasibility of IV Tc-99m-tilmanocept for Imaging of M2-like TAMs in Metastatic Melanoma,Pilot Study to Test the Feasibility of IV Injected Tc-99m-tilmanocept for Imaging of M2-like Tumour Associated Macrophages in Metastatic Melanoma,TERMINATED,,EARLY_PHASE1,5.0,ACTUAL,University of Lausanne Hospitals,,1.0,,"after inclusion of 5 patients, tracer had low uptake (kidney/liver)",f,,,,,f,f,,,,,,,,,NO,,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,OTHER,,,,,,,2023,0.0
NCT04033562,,2019-07-22,,,2021-06-03,2019-07-22,2019-07-26,ACTUAL,,,,,,,2021-06-03,2021-06-07,ACTUAL,2020-01-15,ACTUAL,2020-01-15,2021-06,2021-06-30,2021-05-17,ACTUAL,2021-05-17,2021-05-17,ACTUAL,2021-05-17,,INTERVENTIONAL,,,The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis,The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis,TERMINATED,,PHASE4,2.0,ACTUAL,WellSpan Health,,2.0,,limited enrollment and unable to enroll subjects to reach statistical significance,f,,,,t,t,t,,,f,,,,,,,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,OTHER,,,,,,,2021,0.0
NCT03862248,,2019-02-04,,,2020-01-16,2019-03-01,2019-03-05,ACTUAL,,,,,,,2020-01-16,2020-01-21,ACTUAL,2019-09-30,ESTIMATED,2019-09-30,2020-01,2020-01-31,2022-10-01,ESTIMATED,2022-10-01,2022-10-01,ESTIMATED,2022-10-01,,INTERVENTIONAL,TriDoRe,,Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More,Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More,WITHDRAWN,,PHASE3,0.0,ACTUAL,"Institute of Tropical Medicine, Belgium",,3.0,,Feasibility of the clinical trial could not be confirmed at the different sites.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,OTHER,,,,,,,2022,0.0
NCT04308681,,2020-03-12,,2023-07-26,2023-10-19,2020-03-12,2020-03-16,ACTUAL,,,,,2023-08-01,ACTUAL,2023-10-19,2023-10-24,ACTUAL,2020-07-29,ACTUAL,2020-07-29,2023-10,2023-10-31,2023-09-22,ACTUAL,2023-09-22,2022-08-04,ACTUAL,2022-08-04,,INTERVENTIONAL,,,"A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis","A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants With Pulmonary Fibrosis",COMPLETED,,PHASE2,399.0,ACTUAL,Bristol-Myers Squibb,,6.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,INDUSTRY,,,,,,,2023,0.0
NCT02656017,,2015-12-23,2021-12-07,,2022-08-06,2016-01-12,2016-01-14,ESTIMATED,2022-08-06,2022-08-09,ACTUAL,,,,2022-08-06,2022-08-09,ACTUAL,2016-06-27,ACTUAL,2016-06-27,2022-08,2022-08-31,2020-12-07,ACTUAL,2020-12-07,2020-12-07,ACTUAL,2020-12-07,,INTERVENTIONAL,TAME,,Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease,Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease,COMPLETED,,PHASE2,97.0,ACTUAL,University of Pittsburgh,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,OTHER,,,,,,,2020,1.0
NCT02086175,,2014-03-11,2020-08-04,,2024-04-05,2014-03-11,2014-03-13,ESTIMATED,2020-12-14,2021-01-07,ACTUAL,,,,2024-04-05,2024-04-09,ACTUAL,2014-12,ACTUAL,2014-12-31,2024-04,2024-04-30,2021-02-01,ACTUAL,2021-02-01,2019-07-11,ACTUAL,2019-07-11,,INTERVENTIONAL,,,A Phase 2 Clinical Trial of Rituxan and B-Glucan PGG in Relapsed Indolent Non-Hodgkin Lymphoma,A Phase 2 Clinical Trial of Rituxan and B-Glucan PGG in Relapsed Indolent Non-Hodgkin Lymphoma,COMPLETED,,PHASE2,25.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,,f,,,,t,,,,,,,,Data can be shared no earlier than 1 year following the date of publication,DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,OTHER,,,,,,,2021,1.0
NCT03147196,,2017-05-08,,,2019-01-17,2017-05-08,2017-05-10,ACTUAL,,,,,,,2019-01-17,2019-01-22,ACTUAL,2017-06-27,ACTUAL,2017-06-27,2019-01,2019-01-31,2022-06,ESTIMATED,2022-06-30,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,Bicalutamide and Raloxifene Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery,Neoadjuvant Treatment of Prostate Cancer With Bicalutamide and Raloxifene Prior to Radical Prostatectomy,WITHDRAWN,,PHASE2,0.0,ACTUAL,Mayo Clinic,,4.0,,lack of accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,OTHER,,,,,,,2022,0.0
NCT03583333,,2018-06-28,2023-05-26,,2023-06-27,2018-06-28,2018-07-11,ACTUAL,2023-06-27,2023-06-28,ACTUAL,,,,2023-06-27,2023-06-28,ACTUAL,2018-09-18,ACTUAL,2018-09-18,2023-06,2023-06-30,2022-07-12,ACTUAL,2022-07-12,2022-07-12,ACTUAL,2022-07-12,,INTERVENTIONAL,,,Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016),"A Multi-national Phase 3, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia",COMPLETED,,PHASE3,274.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,f,t,f,,,t,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,INDUSTRY,,,,,,,2022,1.0
NCT03633396,,2018-07-19,2022-05-05,,2022-05-05,2018-08-13,2018-08-16,ACTUAL,2022-05-05,2022-05-31,ACTUAL,,,,2022-05-05,2022-05-31,ACTUAL,2019-05-20,ACTUAL,2019-05-20,2022-05,2022-05-31,2021-04-23,ACTUAL,2021-04-23,2021-04-23,ACTUAL,2021-04-23,,INTERVENTIONAL,POPLAR,Intent-to-treat analysis set (all randomized participants),A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis,"A Phase 2, Randomized, Placebo-controlled, Double-blind, Multiple Dose Study to Evaluate the Efficacy and Safety of ANB019 in Subjects With Palmoplantar Pustulosis",COMPLETED,,PHASE2,59.0,ACTUAL,"AnaptysBio, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,INDUSTRY,,,,,,,2021,1.0
NCT05654779,,2022-12-08,,,2023-12-06,2022-12-08,2022-12-16,ACTUAL,,,,,,,2023-12-06,2023-12-13,ACTUAL,2022-12-12,ACTUAL,2022-12-12,2022-11,2022-11-30,2023-09-26,ACTUAL,2023-09-26,2023-09-26,ACTUAL,2023-09-26,,INTERVENTIONAL,,,CLL-1/CD33 Targeted LCAR-AMDR Cells in Patients With Relapsed or Refractory Acute Myeloid Leukemia,"A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of CLL1-/CD33 Targeted LCAR-AMDR Cells Product in Patients With Relapsed/Refractory Acute Myeloid Leukemia",TERMINATED,,PHASE1,4.0,ACTUAL,"Institute of Hematology & Blood Diseases Hospital, China",,1.0,,Both the sponsors and collaborator are considering terminating the study,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,OTHER,,,,,,,2023,0.0
NCT03617172,,2018-08-01,2022-08-24,,2022-11-10,2018-08-01,2018-08-06,ACTUAL,2022-11-10,2022-11-30,ACTUAL,,,,2022-11-10,2022-11-30,ACTUAL,2018-11-26,ACTUAL,2018-11-26,2022-11,2022-11-30,2021-09-22,ACTUAL,2021-09-22,2021-09-22,ACTUAL,2021-09-22,,INTERVENTIONAL,PROCLAIM,,PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol,"A Randomized, Double-Blind, Placebo-Controlled Trial to Assess The Efficacy and Safety of Misoprostol in The Prevention of Recurrence of Clostridium Difficile Infection in Adults",TERMINATED,,PHASE2,6.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,Low enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,OTHER,,,,,,,2021,0.0
NCT03977584,,2019-06-05,2024-01-25,2023-04-18,2024-03-13,2019-06-05,2019-06-06,ACTUAL,2024-03-13,2024-03-15,ACTUAL,,2024-03-15,ACTUAL,2024-03-13,2024-03-15,ACTUAL,2019-06-10,ACTUAL,2019-06-10,2024-03,2024-03-31,2022-04-19,ACTUAL,2022-04-19,2022-04-19,ACTUAL,2022-04-19,,INTERVENTIONAL,,Intent-to-Treat population (ITT) population included all randomized participants who received the assigned study treatment,Tau Positron Emission Tomography (PET) Longitudinal Substudy Associated With: Study of Crenezumab Versus Placebo in Preclinical Presenilin1 (PSEN1) E280A Mutation Carriers in the Treatment of Autosomal-Dominant Alzheimer's Disease,"Tau PET Longitudinal Substudy Associated With: A Double-Blind, Placebo-Controlled Parallel-Group Study in Preclinical PSEN1 E280A Mutation Carriers Randomized to Crenezumab or Placebo, and in Non-randomized, Placebo-treated Non-carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Crenezumab in the Treatment of Autosomal-Dominant Alzheimer's Disease",COMPLETED,,PHASE2,114.0,ACTUAL,Hoffmann-La Roche,,3.0,,,f,,,,,t,f,,,t,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,INDUSTRY,,,,,,,2022,1.0
NCT04117607,,2019-09-12,2021-05-06,,2021-06-25,2019-10-03,2019-10-07,ACTUAL,2021-06-25,2021-07-16,ACTUAL,,,,2021-06-25,2021-07-16,ACTUAL,2019-12-04,ACTUAL,2019-12-04,2020-06-18,2020-06-18,2020-05-11,ACTUAL,2020-05-11,2020-05-11,ACTUAL,2020-05-11,,INTERVENTIONAL,,Number of subjects randomized.,Safety and Pharmacokinetics of Rezafungin,"A Phase 1, Three-Part, Randomized, Double-Blind, Single and Multiple Subcutaneous Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of Rezafungin in Healthy Adult Subjects",TERMINATED,,PHASE1,14.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,12.0,,Stopped due to the formation of injection site skin nodules.,f,,,,,t,f,,,f,,,,,,,,2024-10-16 14:24:01.891492,2024-10-16 14:24:01.891492,NIH,,,,,,,2020,0.0
NCT03231475,,2017-06-06,,,2021-10-31,2017-07-26,2017-07-27,ACTUAL,,,,,,,2021-10-31,2021-11-08,ACTUAL,2017-07-21,ACTUAL,2017-07-21,2021-10,2021-10-31,2022-03-31,ESTIMATED,2022-03-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,SPH1188-11,,Phase I Study of SPH1188-11 in NSCLC,"Phase I, Open-label Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of SPH1188-11 Tablets for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC).",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Shanghai Pharmaceuticals Holding Co., Ltd",,1.0,,Board decision,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,INDUSTRY,,,,,,,2022,0.0
NCT02356458,,2015-02-02,,,2022-02-24,2015-02-02,2015-02-05,ESTIMATED,,,,,,,2022-02-24,2022-03-11,ACTUAL,2015-08-31,ACTUAL,2015-08-31,2022-02,2022-02-28,2021-03-30,ACTUAL,2021-03-30,2021-03-30,ACTUAL,2021-03-30,,INTERVENTIONAL,,,Combination of Ibrutinib and Bortezomib to Treat Patients With Mantle Cell Lymphoma,Combination of Ibrutinib and Bortezomib Followed by Ibrutinib Maintenance to Treat Patients With Relapsed and Refractory Mantle Cell Lymphoma; a Multicenter Phase I/II Trial.,TERMINATED,,PHASE1/PHASE2,58.0,ACTUAL,Swiss Group for Clinical Cancer Research,,1.0,,SAKK Board decision of 14th November 2020 due to financial reasons.,f,,,,f,,,,,,,,,,,NO,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,OTHER,,,,,,,2021,0.0
NCT05543356,,2022-09-14,,,2024-03-13,2022-09-14,2022-09-16,ACTUAL,,,,,,,2024-03-13,2024-03-15,ACTUAL,2022-05-02,ACTUAL,2022-05-02,2024-03,2024-03-31,2022-11-30,ACTUAL,2022-11-30,2022-07-25,ACTUAL,2022-07-25,,INTERVENTIONAL,,,COVID-19 Fourth Dose Study in Australia,"A Randomised Controlled Trial to Assess the Immunogenicity, Safety and Reactogenicity of a Second Standard Monovalent (Ancestral) or Bivalent Omicron-specific COVID-19 Vaccine Booster Dose (Pfizer-BioNTech or Moderna) in Healthy Adults in Australia.",WITHDRAWN,,PHASE3,0.0,ACTUAL,Murdoch Childrens Research Institute,,8.0,,Withdrawal of supply of vaccine from one manufacturer,f,,,,t,t,f,,,t,,,Individual participant data (IPD) sharing plans in development,In development,,YES,We will share de-identified data to ethically approved studies in cases where participants have indicated on the consent form that they consent to the use of their data and where consistent with terms of collaboration agreements.,2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,OTHER,,,,,,,2022,0.0
NCT04867252,,2021-04-24,,,2021-09-06,2021-04-27,2021-04-30,ACTUAL,,,,,,,2021-09-06,2021-09-13,ACTUAL,2021-05-03,ACTUAL,2021-05-03,2021-09,2021-09-30,2021-08-03,ACTUAL,2021-08-03,2021-08-03,ACTUAL,2021-08-03,,INTERVENTIONAL,,,"Effects of Combined Resveratrol and Myo-inositol on Altered Metabolic, Endocrine Parameters and Perceived Stress in Patients With Polycystic Ovarian Syndrome","Effects of Combined Resveratrol and Myo-inositol on Altered Metabolic, Endocrine Parameters and Perceived Stress in Patients With Polycystic Ovarian Syndrome",COMPLETED,,PHASE2,88.0,ACTUAL,Khyber Medical University Peshawar,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,OTHER,,,,,,,2021,1.0
NCT03724149,,2018-10-26,2023-03-20,,2023-04-13,2018-10-26,2018-10-30,ACTUAL,2023-04-13,2023-04-14,ACTUAL,,,,2023-04-13,2023-04-14,ACTUAL,2018-12-12,ACTUAL,2018-12-12,2023-04,2023-04-30,2022-12-31,ACTUAL,2022-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,SHELTER,,Transplanting Hepatitis C Lungs Into Negative Lung Recipients,Open-Labeled Trial Of Direct-acting Antiviral Treatment Of Hepatitis C-Negative Patients Who Receive Lung Transplants From Hepatitis C-Positive Donors,COMPLETED,,PHASE1/PHASE2,10.0,ACTUAL,University of Pennsylvania,,1.0,,,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,OTHER,,,,,,,2022,1.0
NCT02579096,,2015-10-15,2021-12-17,,2024-03-27,2015-10-15,2015-10-19,ESTIMATED,2021-12-17,2022-01-11,ACTUAL,,,,2024-03-27,2024-03-29,ACTUAL,2017-03-06,ACTUAL,2017-03-06,2024-03,2024-03-31,2021-04-15,ACTUAL,2021-04-15,2021-02-01,ACTUAL,2021-02-01,,INTERVENTIONAL,,,CSP594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat,CSP #594 - Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat,COMPLETED,,PHASE4,950.0,ACTUAL,VA Office of Research and Development,,2.0,,,f,,,,t,t,f,,,f,,,After primary and secondary analyses and subsequent publications,Executed data use agreement with CSP Coordinating Center approval,https://www.research.va.gov/programs/csp/default.cfm,YES,Individual Participant Data will be made available after study closure only to research credentialed Veterans Affairs researchers who submit a valid study question to their IRB of record. A Data Use Agreement will be in effect between the researcher and the coordinating center,2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,FED,,,,,,,2021,1.0
NCT02207231,,2014-07-31,2017-07-25,2016-06-13,2021-07-22,2014-07-31,2014-08-04,ESTIMATED,2017-09-15,2017-10-19,ACTUAL,2016-06-13,2016-06-15,ESTIMATED,2021-07-22,2021-07-23,ACTUAL,2014-11-26,ACTUAL,2014-11-26,2021-07,2021-07-31,2020-06-17,ACTUAL,2020-06-17,2015-09-29,ACTUAL,2015-09-29,,INTERVENTIONAL,VOYAGE 1,Randomized analysis set included all participants who were randomized at Week 0.,A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis,"Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis",COMPLETED,,PHASE3,837.0,ACTUAL,"Janssen Research & Development, LLC","All participants were on guselkumab after Week 48; therefore, there was no concurrent control group within the study after Week 48.",3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,INDUSTRY,,,,,,,2020,1.0
NCT04625114,,2020-11-05,2022-11-29,,2024-08-01,2020-11-10,2020-11-12,ACTUAL,2024-08-01,2024-08-09,ACTUAL,,,,2024-08-01,2024-08-09,ACTUAL,2020-11-04,ACTUAL,2020-11-04,2024-08,2024-08-31,2022-07-12,ACTUAL,2022-07-12,2022-07-12,ACTUAL,2022-07-12,,INTERVENTIONAL,COV-AAT,"Between Nov2020 and Jun2021, a total of 108 participants were enrolled in the study. 12 subjects did not meet the in- and exclusion criteria and were excluded from randomization. A total of 96 participants received either camostat (N=66) or placebo (N=30). Treatment was interrupted in 4 subjects that had to be hospitalized due to clinical deterioration. Two other subjects chose to withdraw from the study. Analyses were performed on the data of 90 participants who completed treatment.",The Potential of Camostat in COVID-19,The Potential of Oral Camostat in Early COVID-19 Disease in an Ambulatory Setting to Reduce Viral Load and Disease Burden,TERMINATED,,PHASE2,108.0,ACTUAL,"University Hospital, Ghent",,2.0,,"Interim analyses did not show evidence that camostat mesylate under the present conditions (300 mg three times daily for five or 10 consecutive days, fasted state) was effective as an antiviral drug against early phase SARS-CoV-2 disease.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,OTHER,,,,,,,2022,0.0
NCT02462538,,2015-05-18,,,2022-02-15,2015-06-02,2015-06-04,ESTIMATED,,,,,,,2022-02-15,2022-03-03,ACTUAL,2015-11-03,ACTUAL,2015-11-03,2022-02,2022-02-28,2021-11-03,ACTUAL,2021-11-03,2021-11-03,ACTUAL,2021-11-03,,INTERVENTIONAL,,,Brentuximab Vedotin and Imatinib in Patients With Relapsed or Refractory ALK+ ALCL,A Window of Opportunity Trial With Brentuximab Vedotin and Imatinib in Patients With Relapsed or Refractory ALK+ Anaplastic Large Cell Lymphoma or Patients Ineligible for Chemotherapy,TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,Arbeitsgemeinschaft medikamentoese Tumortherapie,,1.0,,"Due to slow recruitment, recruitment of new patients was stopped, FU was completed for enrolled patients",f,,,,f,,,,,,,,,,,,,2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,OTHER,,,,,,,2021,0.0
NCT02519322,,2015-08-04,2023-11-03,,2024-04-03,2015-08-05,2015-08-10,ESTIMATED,2024-04-03,2024-04-05,ACTUAL,,,,2024-04-03,2024-04-05,ACTUAL,2016-02-02,ACTUAL,2016-02-02,2024-04,2024-04-30,2023-01-26,ACTUAL,2023-01-26,2023-01-26,ACTUAL,2023-01-26,,INTERVENTIONAL,,No participants were in the Arm A or Arm B only Arm C,Neoadjuvant and Adjuvant Checkpoint Blockade,Neoadjuvant and Adjuvant Checkpoint Blockade in Patients With Clinical Stage III or Oligometastatic Stage IV Melanoma,COMPLETED,,PHASE2,53.0,ACTUAL,M.D. Anderson Cancer Center,,3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,OTHER,,,,,,,2023,1.0
NCT06159062,,2023-11-20,,,2024-07-14,2023-11-28,2023-12-06,ACTUAL,,,,,,,2024-07-14,2024-07-16,ACTUAL,2024-06-03,ACTUAL,2024-06-03,2024-07,2024-07-31,2024-07-09,ACTUAL,2024-07-09,2024-07-09,ACTUAL,2024-07-09,,INTERVENTIONAL,,,A Clinical Study of 162 in Subjects With Chronic Hepatitis B Virus Infection,"A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 162 With a Single Ascending Dose in Subjects With Chronic Hepatitis B Virus Infection",TERMINATED,,PHASE1,1.0,ACTUAL,"Yangshengtang Co., Ltd",,2.0,,Enrollment difficulty,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,INDUSTRY,,,,,,,2024,0.0
NCT03970109,,2019-05-28,2021-10-19,,2022-03-09,2019-05-28,2019-05-31,ACTUAL,2022-03-09,2022-03-10,ACTUAL,,,,2022-03-09,2022-03-10,ACTUAL,2019-10-08,ACTUAL,2019-10-08,2022-03,2022-03-31,2020-05-22,ACTUAL,2020-05-22,2020-05-22,ACTUAL,2020-05-22,,INTERVENTIONAL,,"Sample sizes are based on the modified intention-to-treat (mITT) analysis set, defined as subjects randomized to participate in the study that took at least one dose of IP and had a non-missing VAS craving primary endpoint.",HLAB-002 of ANS-6637 for Alcohol Use Disorder,Human Laboratory Study of ANS-6637 for Alcohol Use Disorder,TERMINATED,,PHASE2,43.0,ACTUAL,National Institute on Alcohol Abuse and Alcoholism (NIAAA),Early termination leading to small numbers of subjects analyzed.,3.0,,The study was terminated early following enrollment of n=43 due to clinically significant increases in liver enzymes in 3 women following at least 3 weeks of dosing with both doses of ANS-6637.,f,,,,t,t,f,,,,,,,,,NO,The data will be shared under a clinical trials agreement with Amygdala Neurosciences.,2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,NIH,,,,,,,2020,0.0
NCT03729310,,2018-11-01,,,2020-05-26,2018-11-01,2018-11-02,ACTUAL,,,,,,,2020-05-26,2020-05-28,ACTUAL,2020-03,ESTIMATED,2020-03-31,2020-05,2020-05-31,2020-05-26,ACTUAL,2020-05-26,2020-05-26,ACTUAL,2020-05-26,,INTERVENTIONAL,,,Comparison of Two Steroid Nasal Implants Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis,Comparison of Two Steroid Nasal Implants Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,No participants enrolled,f,,,,f,t,t,,,t,,,,,,NO,,2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,OTHER,,,,,,,2020,0.0
NCT04050553,,2019-08-07,2023-01-24,,2023-12-07,2019-08-07,2019-08-08,ACTUAL,2023-12-07,2024-05-20,ACTUAL,,,,2023-12-07,2024-05-20,ACTUAL,2020-02-24,ACTUAL,2020-02-24,2023-12,2023-12-31,2022-01-25,ACTUAL,2022-01-25,2022-01-25,ACTUAL,2022-01-25,,INTERVENTIONAL,,All randomized participants.,A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus,"A Randomized, Placebo-Controlled, Crossover Study to Investigate the Effect of Once-Weekly Tirzepatide on the Counter-Regulatory Response to Hypoglycemia in Patients With Type 2 Diabetes Mellitus",COMPLETED,,PHASE1,42.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,INDUSTRY,,,,,,,2022,1.0
NCT04564417,,2020-08-31,,,2024-01-29,2020-09-21,2020-09-25,ACTUAL,,,,,,,2024-01-29,2024-01-31,ACTUAL,2020-09-08,ACTUAL,2020-09-08,2023-07,2023-07-31,2023-12-19,ACTUAL,2023-12-19,2023-12-19,ACTUAL,2023-12-19,,INTERVENTIONAL,,,First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid Tumors,"Phase I Dose Escalation and Dose Expansion, International, Multicenter Study of W0180 as Single Agent and in Combination With Pembrolizumab (Anti-PD-1) in Adult Participants With Locally Advanced or Metastatic Solid Tumors",TERMINATED,,PHASE1,33.0,ACTUAL,Pierre Fabre Medicament,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,INDUSTRY,,,,,,,2023,0.0
NCT04602507,,2020-10-22,,,2021-12-14,2020-10-23,2020-10-26,ACTUAL,,,,,,,2021-12-14,2022-01-04,ACTUAL,2020-12-10,ACTUAL,2020-12-10,2021-12,2021-12-31,2021-12-09,ACTUAL,2021-12-09,2021-12-09,ACTUAL,2021-12-09,,INTERVENTIONAL,,,Ivermectin in Adults With Severe COVID-19.,Ivermectin in Adults With Severe COVID-19. Double-blind Randomized Clinical Trial,TERMINATED,,PHASE2,75.0,ACTUAL,CES University,,2.0,,Lack of severe COVID-19 cases in the place of study,f,,,,t,f,f,,,,,,One year,Under direct request to principal investigator,,YES,"For a reasonable scientific purpose, we may share individual patient data (IPD) that underlie results in a publication under direct request to the principal investigator. We reserve our right to share IPD.",2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,OTHER,,,,,,,2021,0.0
NCT04502069,,2020-07-10,,,2020-08-09,2020-08-04,2020-08-06,ACTUAL,,,,,,,2020-08-09,2020-08-11,ACTUAL,2020-08,ESTIMATED,2020-08-31,2020-08,2020-08-31,2021-06,ESTIMATED,2021-06-30,2021-02,ESTIMATED,2021-02-28,,INTERVENTIONAL,Opaganib-RHB,,Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen,Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen But Not Mechanical Ventilation,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,RedHill Biopharma Limited,,1.0,,To be replaced with a randomized placebo-controlled study.,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,INDUSTRY,,,,,,,2021,0.0
NCT03464136,,2018-03-07,2021-12-14,,2023-06-01,2018-03-07,2018-03-13,ACTUAL,2021-12-14,2022-01-11,ACTUAL,,,,2023-06-01,2023-06-05,ACTUAL,2018-03-29,ACTUAL,2018-03-29,2023-06,2023-06-30,2021-05-21,ACTUAL,2021-05-21,2020-12-15,ACTUAL,2020-12-15,,INTERVENTIONAL,SEAVUE,,Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year,"A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease",COMPLETED,,PHASE3,386.0,ACTUAL,"Janssen Scientific Affairs, LLC",,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,INDUSTRY,,,,,,,2021,1.0
NCT03858049,,2019-02-26,2022-09-01,,2023-08-22,2019-02-26,2019-02-28,ACTUAL,2023-08-22,2024-03-12,ACTUAL,,,,2023-08-22,2024-03-12,ACTUAL,2019-05-31,ACTUAL,2019-05-31,2023-08,2023-08-31,2021-10-27,ACTUAL,2021-10-27,2021-10-27,ACTUAL,2021-10-27,,INTERVENTIONAL,,Intention-to-Treat (ITT) population included all participants who received at least one dose of randomized study intervention.,Efficacy and Safety of Crinone Versus Combination Medication (ACCESS),"Comparison of Crinone ® Versus Combination Medication for Luteal Phase Support on the Ongoing Pregnancy Rate of Frozen-thawed Cycle in Chinese Population a Randomized, Interventional, Open-label, Phase IV, Single Center, Pilot Study (ACCESS)",TERMINATED,,PHASE4,172.0,ACTUAL,"Merck KGaA, Darmstadt, Germany",,2.0,,"The trend in LPS treatment tends to increase the dosage of progesterone in FET-HRT, this study was designed 5 years ago.",f,,,,f,f,f,,,,,,Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union,Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.,http://bit.ly/IPD21,YES,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21",2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,INDUSTRY,,,,,,,2021,0.0
NCT04217720,,2019-10-31,,,2021-08-09,2020-01-02,2020-01-03,ACTUAL,,,,,,,2021-08-09,2021-08-12,ACTUAL,2020-04-01,ESTIMATED,2020-04-01,2021-08,2021-08-31,2023-01-01,ESTIMATED,2023-01-01,2022-01-01,ESTIMATED,2022-01-01,,INTERVENTIONAL,,,SNS-301 Monotherapy in High Risk MDS and CMML,"An Open-Label, Multi-Center Phase 2 Clinical Trial Evaluating SNS-301 in Patients With ASPH+ High Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Sensei Biotherapeutics, Inc.",,1.0,,Sponsor decision,f,,,,f,t,f,,,,,,Beginning 9 months and ending 36 months following article publication.,"Access will be considered to researchers who provide a methodologically sound proposal. Analysis must achieve the aims outlined in the approved proposal Proposals should be directed to info@senseibio.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 36 months following article publication.",,YES,"Individual participant data that underline the results reported in the article, after deidentification (text, tables, figures and appendices) will be shared to researchers who have provide a methodologically sound proposal and sign a data access agreement.",2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,INDUSTRY,,,,,,,2023,0.0
NCT03784443,,2018-12-19,,,2023-09-29,2018-12-20,2018-12-21,ACTUAL,,,,,,,2023-09-29,2023-10-02,ACTUAL,2019-09-01,ESTIMATED,2019-09-01,2023-09,2023-09-30,2023-09-01,ESTIMATED,2023-09-01,2022-09-01,ESTIMATED,2022-09-01,,INTERVENTIONAL,CASSIE,,Combined Ranibizumab and Iluvien for Diabetic Macular Oedema,Combined Anti-VEGF Intravitreal Injections With Sustained Steroid Implantation for the Treatment of Diabetic Macular Oedema,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Imperial College London,,2.0,,Funder withdrawn funding.,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,OTHER,,,,,,,2023,0.0
NCT03338777,,2017-10-10,,,2020-02-21,2017-11-08,2017-11-09,ACTUAL,,,,,,,2020-02-21,2020-02-25,ACTUAL,2020-02-20,ACTUAL,2020-02-20,2020-02,2020-02-29,2020-02-20,ACTUAL,2020-02-20,2020-02-20,ACTUAL,2020-02-20,,INTERVENTIONAL,IGTM-101,,Suicide Plus Immune Gene Therapy for Advanced Melanoma,Phase 1 Suicide Plus Immune Gene Therapy for Advanced Melanoma,TERMINATED,,EARLY_PHASE1,4.0,ACTUAL,Hospital Italiano de Buenos Aires,,1.0,,Failure to achieve primary objective,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,OTHER,,,,,,,2020,0.0
NCT04363203,,2020-04-23,,,2020-06-18,2020-04-24,2020-04-27,ACTUAL,,,,,,,2020-06-18,2020-06-22,ACTUAL,2020-04-30,ACTUAL,2020-04-30,2020-06,2020-06-30,2021-08,ESTIMATED,2021-08-31,2021-03,ESTIMATED,2021-03-31,,INTERVENTIONAL,VA-REACH,,VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL),VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL),SUSPENDED,,PHASE3,300.0,ESTIMATED,San Francisco VA Health Care System,,3.0,,concerns related to study drug,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,FED,,,,,,,2021,0.0
NCT04051996,,2019-08-07,2021-09-18,,2021-09-18,2019-08-07,2019-08-09,ACTUAL,2021-09-18,2021-10-15,ACTUAL,,,,2021-09-18,2021-10-15,ACTUAL,2019-12-06,ACTUAL,2019-12-06,2021-09,2021-09-30,2020-06-09,ACTUAL,2020-06-09,2020-06-09,ACTUAL,2020-06-09,,INTERVENTIONAL,,Only 1 patient was enrolled in the study prior to termination and therefore would be identified through presenting these characteristics.,GLAD-AML - Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia,"A Randomized, Parallel-arm, Phase 2 Clinical Trial of the Combination of Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia Who Are Unfit for or Refuse Intensive Chemotherapy (GLAD-AML)",TERMINATED,,PHASE2,1.0,ACTUAL,Yale University,,2.0,,Unable to accrue patients following COVID-19 study pause.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,OTHER,,,,,,,2020,0.0
NCT03174184,,2017-05-30,2023-05-12,,2023-06-27,2017-05-30,2017-06-02,ACTUAL,2023-06-27,2023-07-19,ACTUAL,,,,2023-06-27,2023-07-19,ACTUAL,2017-08-23,ACTUAL,2017-08-23,2023-06,2023-06-30,2022-05-13,ACTUAL,2022-05-13,2022-05-13,ACTUAL,2022-05-13,,INTERVENTIONAL,,,Early Bactericidal Activity of Rifampin + Meropenem + Amoxicillin/Clavulanate in Adults With Pulmonary TB,A Phase 2a Study of the Early Bactericidal Activity of Rifampin (RIF) in Combination With Meropenem Plus Amoxicillin/Clavulanate Among Adults With Rifampin-resistant or Rifampin-susceptible Pulmonary Tuberculosis,COMPLETED,,PHASE2,112.0,ACTUAL,Johns Hopkins University,,6.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,OTHER,,,,,,,2022,1.0
NCT04046328,,2019-07-26,2022-05-30,,2022-06-23,2019-08-02,2019-08-06,ACTUAL,2022-06-23,2022-07-19,ACTUAL,,,,2022-06-23,2022-07-19,ACTUAL,2019-10-15,ACTUAL,2019-10-15,2022-06,2022-06-30,2021-12-22,ACTUAL,2021-12-22,2021-12-22,ACTUAL,2021-12-22,,INTERVENTIONAL,,,"Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome","A Phase IIa, Proof of Concept, Randomized, Double-Blind, Dose-Finding, Cross-Over Study of the Efficacy, Safety and Tolerability of a New Enteric-Coated Cholestyramine Capsule in Adult Short Bowel Syndrome Patients",TERMINATED,,PHASE2,13.0,ACTUAL,Pharmascience Inc.,Early termination leading to small numbers of subjects analyzed and abbreviated statistical analyses.,2.0,,Difficult recruitment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,INDUSTRY,,,,,,,2021,0.0
NCT04864522,,2021-03-30,,,2023-11-16,2021-04-27,2021-04-29,ACTUAL,,,,,,,2023-11-16,2023-11-21,ACTUAL,2023-08,ESTIMATED,2023-08-31,2023-11,2023-11-30,2023-11,ESTIMATED,2023-11-30,2023-11,ESTIMATED,2023-11-30,,INTERVENTIONAL,MM FPBMC,,Phase I/II Study of SLAMF7 FPBMC/CS-1 FPBMC in Relapsed/Refractory Multiple Myeloma,Phase I/II Study of Anti-CD3 x Anti-SLAMF7 (Anti-CS-1) Bispecific Antibody Armed Fresh Peripheral Blood Mononuclear Cells (SLAMF7 FPBMC) in Relapsed/Refractory Multiple Myeloma,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,University of Virginia,,1.0,,Slow accrual due to a crowded field of effective drugs by the time the study opened,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,OTHER,,,,,,,2023,0.0
NCT03773978,,2018-12-11,2022-07-22,,2022-09-08,2018-12-11,2018-12-12,ACTUAL,2022-09-08,2022-10-07,ACTUAL,,,,2022-09-08,2022-10-07,ACTUAL,2018-12-17,ACTUAL,2018-12-17,2022-09,2022-09-30,2022-01-26,ACTUAL,2022-01-26,2022-01-26,ACTUAL,2022-01-26,,INTERVENTIONAL,JUVE-BASIS,Baseline analysis Population includes all randomized participants.,A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis,"A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JIA)",COMPLETED,,PHASE3,220.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,INDUSTRY,,,,,,,2022,1.0
NCT04233801,,2020-01-16,2023-03-08,,2023-03-08,2020-01-16,2020-01-18,ACTUAL,2023-03-08,2023-12-15,ACTUAL,,,,2023-03-08,2023-12-15,ACTUAL,2020-04-15,ACTUAL,2020-04-15,2023-03,2023-03-31,2022-03-10,ACTUAL,2022-03-10,2022-03-03,ACTUAL,2022-03-03,,INTERVENTIONAL,,Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.,A Study to Test How Well Empagliflozin Works in Chinese Patients With Type 2 Diabetes Who Already Take Insulin,"A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Empagliflozin (10 mg and 25 mg) Administered Orally Once Daily in Combination With Insulin With or Without up to Two Oral Anti-diabetic Agents for 24 Weeks in Chinese Type 2 Diabetic Patients With Insufficient Glycemic Control.",COMPLETED,,PHASE3,219.0,ACTUAL,Boehringer Ingelheim,,3.0,,,f,,,,,f,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets",2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,INDUSTRY,,,,,,,2022,1.0
NCT03617224,,2018-07-27,,,2020-04-20,2018-08-03,2018-08-06,ACTUAL,,,,,,,2020-04-20,2020-04-22,ACTUAL,2018-07-24,ACTUAL,2018-07-24,2020-04,2020-04-30,2024-07-24,ESTIMATED,2024-07-24,2022-07-24,ESTIMATED,2022-07-24,,INTERVENTIONAL,,,Pembrolizumab and Total Skin Electron Beam Radiotherapy in Mycosis Fungoides and Sézary Syndrome,Phase I Trial of Pembrolizumab and Total Skin Electron Beam Radiotherapy in Mycosis Fungoides and Sézary Syndrome,WITHDRAWN,,PHASE1,0.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,Unable to enroll patients that met enrollment criteria.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,OTHER,,,,,,,2024,0.0
NCT04189848,,2019-12-04,2021-01-28,,2022-11-04,2019-12-04,2019-12-06,ACTUAL,2021-01-28,2021-02-17,ACTUAL,,,,2022-11-04,2022-11-07,ACTUAL,2019-12-03,ACTUAL,2019-12-03,2022-11,2022-11-30,2020-02-27,ACTUAL,2020-02-27,2020-01-29,ACTUAL,2020-01-29,,INTERVENTIONAL,,Full analysis set (FAS) included all randomised subjects who had received at least 1 injection of semaglutide or dulaglutide (included any skin contact with trial product whether the injection was completed or not).,Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc,A Trial to Complare the Injection Site Pain Experience of Semaglutide 0.25 mg and Dulaglutide 0.75 mg Administered sc,COMPLETED,,PHASE4,104.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,f,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 14:30:30.511093,2024-10-16 14:30:30.511093,INDUSTRY,,,,,,,2020,1.0
NCT04070781,,2019-08-26,,,2024-05-31,2019-08-26,2019-08-28,ACTUAL,,,,,,,2024-05-31,2024-06-04,ACTUAL,2020-01-20,ACTUAL,2020-01-20,2024-05,2024-05-31,2021-12-13,ACTUAL,2021-12-13,2021-12-13,ACTUAL,2021-12-13,,INTERVENTIONAL,GVHD,,Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease,Phase I Study of Itacitinib in Combination With Tocilizumab for the Treatment of Steroid Refractory Acute Graft Versus Host Disease,TERMINATED,,PHASE1,1.0,ACTUAL,Columbia University,,2.0,,The primary reason for study closure is slow enrollment.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,OTHER,,,,,,,2021,0.0
NCT02288832,,2014-10-30,,,2023-04-12,2014-11-07,2014-11-11,ESTIMATED,,,,,,,2023-04-12,2023-04-13,ACTUAL,2015-03-06,ACTUAL,2015-03-06,2015-11,2015-11-30,2022-10-21,ACTUAL,2022-10-21,2018-07-01,ACTUAL,2018-07-01,,INTERVENTIONAL,AuTop,,Medico-economic Impact of Screening Atopobium Vaginae and Gardnerella Vaginalis in Molecular Biology by Point-of-care During Pregnancy,Medico-economic Impact of Screening Atopobium Vaginae and Gardnerella Vaginalis in Molecular Biology by Point-of-care During Pregnancy,COMPLETED,,PHASE2/PHASE3,6800.0,ACTUAL,Assistance Publique Hopitaux De Marseille,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,OTHER,,,,,,,2022,0.0
NCT04094870,,2019-09-16,2021-09-01,,2021-10-12,2019-09-16,2019-09-19,ACTUAL,2021-10-12,2021-11-10,ACTUAL,,,,2021-10-12,2021-11-10,ACTUAL,2019-10-30,ACTUAL,2019-10-30,2020-12,2020-12-31,2020-10-30,ACTUAL,2020-10-30,2020-10-30,ACTUAL,2020-10-30,,INTERVENTIONAL,,,A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women,Z 31801 - A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women,COMPLETED,,PHASE4,80.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,,f,,,,t,t,f,,,t,,,9 to 36 months following publication,"Investigator who proposes to use the data has IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.",,YES,"Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.",2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,OTHER,,,,,,,2020,1.0
NCT03735758,,2018-11-07,,,2021-09-15,2018-11-07,2018-11-08,ACTUAL,,,,,,,2021-09-15,2021-09-22,ACTUAL,2018-11-02,ACTUAL,2018-11-02,2019-09,2019-09-30,2020-10-06,ACTUAL,2020-10-06,2020-10-06,ACTUAL,2020-10-06,,INTERVENTIONAL,PazoQoL,,Quality of Life in Patients With Non-adipocyte Soft Tissue Sarcoma Under Palliative Chemotherapy or Pazopanib,"Quality of Life in Patients With Non-adipocyte Soft Tissue Sarcoma Under Palliative Chemotherapy or Pazopanib - a Randomized, Controlled Trial",TERMINATED,,PHASE4,11.0,ACTUAL,GWT-TUD GmbH,,2.0,,problems with recruiting,f,,,,f,f,f,,,,,,,,,,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,OTHER,,,,,,,2020,0.0
NCT02958709,,2016-09-13,,,2021-10-27,2016-11-04,2016-11-08,ESTIMATED,,,,,,,2021-10-27,2021-10-28,ACTUAL,2017-02-22,ACTUAL,2017-02-22,2020-08,2020-08-31,2020-11-15,ACTUAL,2020-11-15,2020-11-15,ACTUAL,2020-11-15,,INTERVENTIONAL,TBM-KIDS,,Optimizing Treatment to Improve TBM Outcomes in Children,"Phase I/II Randomized, Open-label Trial to Evaluate the PK, Safety, and Outcomes of Treatment Including High Dose Rifampicin +/- Levofloxacin vs Standard Treatment for Pediatric Tuberculous Meningitis (TBM)",COMPLETED,,PHASE1/PHASE2,38.0,ACTUAL,Johns Hopkins University,,3.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,OTHER,,,,,,,2020,1.0
NCT02870920,,2016-08-10,2020-11-20,,2023-12-06,2016-08-12,2016-08-17,ESTIMATED,2021-01-12,2021-01-19,ACTUAL,,,,2023-12-06,2023-12-08,ACTUAL,2016-10-12,ACTUAL,2016-10-12,2022-06,2022-06-30,2022-06-07,ACTUAL,2022-06-07,2018-10-18,ACTUAL,2018-10-18,,INTERVENTIONAL,,,Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care in Patients With Advanced Colorectal Cancer,A Phase II Randomized Study of Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care Alone in Patients With Advanced Colorectal Adenocarcinoma Refractory to Standard Therapies,COMPLETED,,PHASE2,180.0,ACTUAL,Canadian Cancer Trials Group,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,NETWORK,,,,,,,2022,1.0
NCT04317066,,2020-03-19,,,2024-05-10,2020-03-19,2020-03-20,ACTUAL,,,,,,,2024-05-10,2024-05-13,ACTUAL,2020-06-26,ACTUAL,2020-06-26,2024-05,2024-05-31,2024-04-11,ACTUAL,2024-04-11,2024-04-11,ACTUAL,2024-04-11,,INTERVENTIONAL,,,A Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-A33/KEYNOTE-A33),A Phase 1 Clinical Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (KEYNOTE-A33),COMPLETED,,PHASE1,7.0,ACTUAL,Merck Sharp & Dohme LLC,,1.0,,,f,,,,f,f,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,INDUSTRY,,,,,,,2024,1.0
NCT03622658,,2018-07-17,2021-12-06,,2022-01-05,2018-08-07,2018-08-09,ACTUAL,2022-01-05,2022-03-08,ACTUAL,,,,2022-01-05,2022-03-08,ACTUAL,2018-09-06,ACTUAL,2018-09-06,2022-01,2022-01-31,2020-02-04,ACTUAL,2020-02-04,2020-02-04,ACTUAL,2020-02-04,,INTERVENTIONAL,NAMASTE,,Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis,A Phase 2a Study to Evaluate the Safety and Efficacy of Namilumab in Subjects With Moderate-to-severely Active Axial Spondyloarthritis,COMPLETED,,PHASE2,42.0,ACTUAL,Izana Bioscience Ltd.,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,INDUSTRY,,,,,,,2020,1.0
NCT02228382,,2014-08-27,2021-10-12,,2021-12-02,2014-08-27,2014-08-29,ESTIMATED,2021-12-02,2021-12-30,ACTUAL,,,,2021-12-02,2021-12-30,ACTUAL,2014-11-07,ACTUAL,2014-11-07,2021-12,2021-12-31,2020-10-13,ACTUAL,2020-10-13,2020-10-13,ACTUAL,2020-10-13,,INTERVENTIONAL,,Safety analysis set included all participants who received at least 1 dose of bosutinib,Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors,A PHASE 4 SAFETY AND EFFICACY STUDY OF BOSUTINIB (BOSULIF (REGISTERED)) IN PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA PREVIOUSLY TREATED WITH ONE OR MORE TYROSINE KINASE INHIBITORS,TERMINATED,,PHASE4,163.0,ACTUAL,Pfizer,,1.0,,,f,,,,f,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,INDUSTRY,,,,,,,2020,0.0
NCT02799602,,2016-06-06,2022-10-25,,2024-03-24,2016-06-10,2016-06-15,ESTIMATED,2023-01-29,2023-02-24,ACTUAL,,,,2024-03-24,2024-04-16,ACTUAL,2016-11-30,ACTUAL,2016-11-30,2024-03,2024-03-31,2023-04-11,ACTUAL,2023-04-11,2021-10-25,ACTUAL,2021-10-25,,INTERVENTIONAL,ARASENS,,Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer,"A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer",COMPLETED,,PHASE3,1306.0,ACTUAL,Bayer,,2.0,,,f,,,,t,,f,,,f,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,INDUSTRY,,,,,,,2023,1.0
NCT04325672,,2020-03-26,,,2020-04-06,2020-03-26,2020-03-27,ACTUAL,,,,,,,2020-04-06,2020-04-08,ACTUAL,2020-04-01,ESTIMATED,2020-04-01,2020-04,2020-04-30,2022-12-31,ESTIMATED,2022-12-31,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Convalescent Plasma to Limit Coronavirus Associated Complications,"Convalescent Plasma to Limit Coronavirus Associated Complications: An Open Label, Phase 2A Study of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19",WITHDRAWN,,PHASE2,0.0,ACTUAL,Mayo Clinic,,1.0,,Study stopped due to opening Expanded Access Protocol.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:24:24.267642,2024-10-15 03:24:24.267642,OTHER,,,,,,,2022,0.0
NCT03066453,,2017-02-23,,,2021-08-30,2017-02-27,2017-02-28,ACTUAL,,,,,,,2021-08-30,2021-09-05,ACTUAL,2017-06-13,ACTUAL,2017-06-13,2021-08,2021-08-31,2020-01-16,ACTUAL,2020-01-16,2020-01-16,ACTUAL,2020-01-16,,INTERVENTIONAL,TOBRAMUC,,Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic Fibrosis,Evaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis.,TERMINATED,,PHASE3,23.0,ACTUAL,"University Hospital, Lille",,2.0,,new treatment that changes the management of the disease,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,OTHER,,,,,,,2020,0.0
NCT05546411,,2022-09-07,2024-05-03,,2024-07-12,2022-09-16,2022-09-19,ACTUAL,2024-07-12,2024-07-16,ACTUAL,,,,2024-07-12,2024-07-16,ACTUAL,2023-01-06,ACTUAL,2023-01-06,2024-07,2024-07-31,2023-10-13,ACTUAL,2023-10-13,2023-08-16,ACTUAL,2023-08-16,,INTERVENTIONAL,,,A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer,A Phase 2 Study of Neoadjuvant NIS793 in Combination With mFOLFIRINOX in Resectable and Borderline Resectable Pancreatic Adenocarcinoma (PDAC),TERMINATED,,PHASE2,8.0,ACTUAL,Dana-Farber Cancer Institute,,2.0,,"Novartis, the drug manufacturer of NIS793, notified Dana Farber Cancer Institute that they are stopping all clinical development of NIS793 in pancreatic cancer, effective immediately.",f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,OTHER,,,,,,,2023,0.0
NCT05780541,,2023-03-20,2024-01-12,,2024-02-07,2023-03-20,2023-03-22,ACTUAL,2024-02-07,2024-02-09,ACTUAL,,,,2024-02-07,2024-02-09,ACTUAL,2021-09-15,ACTUAL,2021-09-15,2024-02,2024-02-29,2023-07-14,ACTUAL,2023-07-14,2022-04-06,ACTUAL,2022-04-06,,INTERVENTIONAL,,,PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial),"A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 (Trial H6: PF-07304814)",TERMINATED,,PHASE3,58.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,The agent was withdrawn from development by the manufacturer after being placed on clinical hold by the US FDA.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,NIH,,,,,,,2023,0.0
NCT02372409,,2015-02-13,2024-07-15,,2024-07-15,2015-02-20,2015-02-26,ESTIMATED,2024-07-15,2024-08-09,ACTUAL,,,,2024-07-15,2024-08-09,ACTUAL,2015-08-14,ACTUAL,2015-08-14,2024-07,2024-07-31,2023-03-23,ACTUAL,2023-03-23,2023-03-23,ACTUAL,2023-03-23,,INTERVENTIONAL,,,Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors,A Pilot Study of Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors,TERMINATED,,PHASE2,6.0,ACTUAL,Washington University School of Medicine,"The protocol stated that participants were to be followed for 5 years from participant registration or until death, whichever occurred first. The original consent that the participants signed stated that they would only be followed for 12 months after MLA. Once this issue was discovered, participants were contacted to be reconsented to be followed for 5 years; however, not all participants were able to be reconsented and that is why the results are late.",2.0,,Low accruals and competing clinical trials,f,,,,t,t,t,,,f,,,,,,NO,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,OTHER,,,,,,,2023,0.0
NCT04638153,,2020-09-15,2024-01-15,,2024-01-15,2020-11-16,2020-11-20,ACTUAL,2024-01-15,2024-02-15,ACTUAL,,,,2024-01-15,2024-02-15,ACTUAL,2020-12-02,ACTUAL,2020-12-02,2024-01,2024-01-31,2023-03-27,ACTUAL,2023-03-27,2023-01-16,ACTUAL,2023-01-16,,INTERVENTIONAL,,Baseline analysis population included all participants who received at least one dose of recifercept.,"A Study Of Safety, Tolerability And Effectiveness Of Recifercept In Children With Achondroplasia","A PHASE 2 MULTIPLE DOSE, RANDOMIZED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA",TERMINATED,,PHASE2,60.0,ACTUAL,Pfizer,"The PK study cohort was not enrolled due to early study termination, therefore, the data of the PK cohort were not collected.",5.0,,The study was terminated due to lack of efficacy at any of the tested doses on 18th November 2022. The decision to terminate the study is not related to a safety concern.,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,INDUSTRY,,,,,,,2023,0.0
NCT04908748,,2021-05-21,2022-11-01,,2023-09-27,2021-05-26,2021-06-01,ACTUAL,2023-09-27,2023-09-28,ACTUAL,,,,2023-09-27,2023-09-28,ACTUAL,2021-05-20,ACTUAL,2021-05-20,2023-09,2023-09-30,2021-12-15,ACTUAL,2021-12-15,2021-11-09,ACTUAL,2021-11-09,,INTERVENTIONAL,,,Efficacy and Safety of Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain,"The Efficacy and Safety of an Esflurbiprofen Hydrogel Patch vs. Placebo in the Local Symptomatic and Short-term Treatment of Pain in Acute Strains, Sprains or Bruises of the Extremities Following Blunt Trauma, e.g. Sports Injuries.",COMPLETED,,PHASE2,200.0,ACTUAL,"Teikoku Seiyaku Co., Ltd.",,2.0,,,,,,,f,t,f,,,,,,,,,NO,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,INDUSTRY,,,,,,,2021,1.0
NCT03960541,,2019-05-15,2022-05-12,,2023-01-11,2019-05-20,2019-05-23,ACTUAL,2022-05-12,2022-06-08,ACTUAL,,,,2023-01-11,2023-02-08,ACTUAL,2020-08-31,ACTUAL,2020-08-31,2023-01,2023-01-31,2021-05-27,ACTUAL,2021-05-27,2021-05-27,ACTUAL,2021-05-27,,INTERVENTIONAL,CALIBER,,"Efprezimod Alfa (CD24Fc, MK-7110) Administration to Decrease Low-Density Lipoprotein (LDL) and Inflammation in Human Immunodeficiency Virus (HIV) Patients (CALIBER) (MK-7110-003)","CD24Fc Administration to Decrease LDL and Inflammation in HIV Patients, Both as Markers of Efficacy and Cardiovascular Risk Reduction (CALIBER)",TERMINATED,,PHASE2,8.0,ACTUAL,"Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)",,2.0,,Business Reasons,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,INDUSTRY,,,,,,,2021,0.0
NCT04366232,,2020-04-27,,,2020-12-11,2020-04-27,2020-04-28,ACTUAL,,,,,,,2020-12-11,2020-12-16,ACTUAL,2020-08-19,ACTUAL,2020-08-19,2020-12,2020-12-31,2020-10-02,ACTUAL,2020-10-02,2020-10-02,ACTUAL,2020-10-02,,INTERVENTIONAL,JAKINCOV,,Efficacy of Intravenous Anakinra and Ruxolitinib During COVID-19 Inflammation,"Interleukin-1 (IL-1) and Interferon Gamma (IFNg) Inhibition During COVID 19 Inflammation: Randomized, Controlled Study Assessing Efficacy and Safety of Anakinra and Ruxolitinib",TERMINATED,,PHASE2,2.0,ACTUAL,Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer,,2.0,,investigator decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,OTHER,,,,,,,2020,0.0
NCT02921737,,2016-09-26,2020-12-15,,2021-01-13,2016-09-29,2016-10-03,ESTIMATED,2021-01-13,2021-02-04,ACTUAL,,,,2021-01-13,2021-02-04,ACTUAL,2017-11-09,ACTUAL,2017-11-09,2021-01,2021-01-31,2020-07-26,ACTUAL,2020-07-26,2020-07-26,ACTUAL,2020-07-26,,INTERVENTIONAL,,,TAS-102 (Lonsurf) in Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Post First Line Chemotherapy (UF-STO-PANC-003),A Phase II Trial of TAS-102 (Lonsurf) in Patients With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma After Progression Through First Line Chemotherapy,TERMINATED,,PHASE2,7.0,ACTUAL,University of Florida,,1.0,,insufficient time to accrue sufficient subjects before end of funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,OTHER,,,,,,,2020,0.0
NCT04955262,,2019-06-26,,,2021-06-28,2021-06-28,2021-07-08,ACTUAL,,,,,,,2021-06-28,2021-07-08,ACTUAL,2019-08,ESTIMATED,2019-08-31,2021-06,2021-06-30,2022-01,ESTIMATED,2022-01-31,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,A CD8 Positron Emission Tomography With Computed Tomography (PET/CT) Study Using ⁸⁹Zr Df-IAB22M2C in Patients With Metastatic Melanoma Receiving Bempegaldesleukin (NKTR-214) and Nivolumab,"A Phase 1b, Open Label, Multicenter Study of Positron Emission Tomography With Computed Tomography (PET/CT) Using ⁸⁹Zr Df-IAB22M2C (CD8 PET/CT Tracer) in Patients With Metastatic Melanoma Receiving Bempegaldesleukin (NKTR-214) and Nivolumab",WITHDRAWN,,PHASE1,0.0,ACTUAL,Nektar Therapeutics,,2.0,,Did not initiate due to business reasons. IND is inactive.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,INDUSTRY,,,,,,,2022,0.0
NCT00788125,,2008-11-07,2021-05-11,,2023-07-11,2008-11-07,2008-11-10,ESTIMATED,2022-04-01,2022-04-27,ACTUAL,,,,2023-07-11,2023-07-14,ACTUAL,2008-09-03,ACTUAL,2008-09-03,2023-07,2023-07-31,2022-07-30,ACTUAL,2022-07-30,2010-04-30,ACTUAL,2010-04-30,,INTERVENTIONAL,,,"Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors","Dasatinib With Ifosfamide, Carboplatin, Etoposide: A Pediatric Phase I/II Trial",TERMINATED,,PHASE1/PHASE2,7.0,ACTUAL,City of Hope Medical Center,,1.0,,Terminated early due a shift in resources after lackluster performance of the drug.,f,,,,t,,,,,,,,,,,,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,OTHER,,,,,,,2022,0.0
NCT03312530,,2017-10-12,2022-05-11,,2023-02-27,2017-10-12,2017-10-17,ACTUAL,2023-02-27,2023-02-28,ACTUAL,,,,2023-02-27,2023-02-28,ACTUAL,2017-11-13,ACTUAL,2017-11-13,2023-02,2023-02-28,2021-05-18,ACTUAL,2021-05-18,2021-05-18,ACTUAL,2021-05-18,,INTERVENTIONAL,,,"A Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Participants With Relapsed and Refractory Multiple Myeloma","A Phase Ib/II Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Patients With Relapsed and Refractory Multiple Myeloma",COMPLETED,,PHASE1/PHASE2,49.0,ACTUAL,Hoffmann-La Roche,"In March 2019, this study was placed on voluntary enrollment hold. In May 2019, after an informal efficacy review, the Sponsor decided not to remove the hold and discontinued further development of the combination.",5.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,INDUSTRY,,,,,,,2021,1.0
NCT04044950,,2019-08-01,,,2020-09-21,2019-08-02,2019-08-05,ACTUAL,,,,,,,2020-09-21,2020-09-22,ACTUAL,2019-07-29,ACTUAL,2019-07-29,2020-09,2020-09-30,2020-09-17,ACTUAL,2020-09-17,2020-09-17,ACTUAL,2020-09-17,,INTERVENTIONAL,,,A Phase II Study of Neoadjuvant E7 TCR T Cell Immunotherapy for Borderline Resectable and Unresectable Stage I HPV-Associated Oropharyngeal Cancer,A Phase II Study of Neoadjuvant E7 TCR T Cell Immunotherapy for Borderline Resectable and Unresectable Stage I HPV-Associated Oropharyngeal Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,The study was closed due to investigator discretion based on the lack of ability to recruit patients and research goals of the program.,f,,,,,t,f,,,,,,,,,,,2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,NIH,,,,,,,2020,0.0
NCT04494659,,2020-07-28,,,2020-09-27,2020-07-28,2020-07-31,ACTUAL,,,,,,,2020-09-27,2020-09-29,ACTUAL,2020-07-20,ACTUAL,2020-07-20,2020-07,2020-07-31,2020-08-31,ACTUAL,2020-08-31,2020-08-13,ACTUAL,2020-08-13,,INTERVENTIONAL,,,A Drug-drug Interaction Trial to Evaluate the Pharmacokinetics Effect of Rifampicin on Famitinib,"A Single Center, Single Arm, Open and Fixed Sequence Study to Investigate the Pharmacokinetic Effects of Rifampicin on Famitinib in Healthy Male Subjects",COMPLETED,,PHASE1,21.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,INDUSTRY,,,,,,,2020,1.0
NCT03325114,,2017-10-20,2020-12-08,,2020-12-08,2017-10-24,2017-10-30,ACTUAL,2020-12-08,2021-01-05,ACTUAL,,,,2020-12-08,2021-01-05,ACTUAL,2019-06-28,ACTUAL,2019-06-28,2020-12,2020-12-31,2020-06-01,ACTUAL,2020-06-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,,"Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.",Safety and Efficacy of Chlorthalidone in Type 1 Diabetes,Safety and Efficacy of Chlorthalidone to Reduce Urinary Calcium Excretion in Adolescents/Yount Adult With Type 1 Diabetes,TERMINATED,,PHASE2,1.0,ACTUAL,University of Rochester,,1.0,,COVID restrictions prohibit further study activies,f,,,,t,t,f,,,t,,,,,,NO,Data will be available in aggregate. No plan to share individual data at present.,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,OTHER,,,,,,,2020,0.0
NCT04757090,,2021-02-15,,,2021-12-07,2021-02-15,2021-02-16,ACTUAL,,,,,,,2021-12-07,2021-12-23,ACTUAL,2021-12-31,ESTIMATED,2021-12-31,2021-12,2021-12-31,2023-12-31,ESTIMATED,2023-12-31,2023-12-31,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111,A Pilot Study of 89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111,WITHDRAWN,,PHASE2,0.0,ACTUAL,Washington University School of Medicine,,1.0,,Insufficient staff,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,OTHER,,,,,,,2023,0.0
NCT03626727,,2018-06-27,,,2021-03-02,2018-08-09,2018-08-13,ACTUAL,,,,,,,2021-03-02,2021-03-04,ACTUAL,2020-09,ESTIMATED,2020-09-30,2021-03,2021-03-31,2020-09-01,ACTUAL,2020-09-01,2020-09-01,ACTUAL,2020-09-01,,INTERVENTIONAL,,,Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia,Open-label Clinical Trial to Evaluate the Efficacy of Sodium Oxybate (Xyrem®) in the Treatment of Two Under-recognized Clinical Conditions: Post-traumatic Narcolepsy and Post-traumatic Hypersomnia,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Brigham and Women's Hospital,,1.0,,Target study population was extremely difficult to recruit and planned study budget was exceeded,f,,,,,t,f,,,,,,,,,,,2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,OTHER,,,,,,,2020,0.0
NCT03883607,,2019-03-13,2021-09-29,,2021-09-29,2019-03-19,2019-03-21,ACTUAL,2021-09-29,2021-10-28,ACTUAL,,,,2021-09-29,2021-10-28,ACTUAL,2019-06-25,ACTUAL,2019-06-25,2021-09,2021-09-30,2020-06-16,ACTUAL,2020-06-16,2020-06-16,ACTUAL,2020-06-16,,INTERVENTIONAL,,Analysis was performed on intent-to-treat (ITT) population that had included participants who were randomized and had received at least 1 dose of the study drug.,"Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)","An Open Label, Randomized, Multicenter Study to Assess the Pharmacokinetic and Pharmacodynamic Profile and the Safety and Tolerability of Two Dose Levels of Elafibranor (80 mg and 120 mg) in Children and Adolescents, 8 to 17 Years of Age, With Nonalcoholic Steatohepatitis (NASH)",TERMINATED,,PHASE2,10.0,ACTUAL,Genfit,"Due to lack of efficacy (but not due to safety) in a Phase 3 trial of elafibranor in adult participants with NASH and fibrosis, this study in pediatric NASH was prematurely terminated. Therefore, participants \>=12 to \<=17 years of age were only involved in this study.",2.0,,"Due to lack of efficacy (but not due to safety) in a Phase 3 trial of elafibranor in adult participants with NASH and fibrosis, this study in pediatric NASH was prematurely terminated",f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,INDUSTRY,,,,,,,2020,0.0
NCT03986970,,2019-06-06,,,2022-07-29,2019-06-11,2019-06-14,ACTUAL,,,,,,,2022-07-29,2022-08-02,ACTUAL,2019-11-11,ACTUAL,2019-11-11,2021-04,2021-04-30,2021-02-25,ACTUAL,2021-02-25,2021-02-25,ACTUAL,2021-02-25,,INTERVENTIONAL,CHAPS,,The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention,Combined HIV Adolescent PrEP and Prevention: On Demand Pre-exposure Prophylaxis to Provide Protection From HIV in Men - Using Foreskin Tissue to Estimate Protection (Phase II),COMPLETED,,PHASE2,72.0,ACTUAL,Wits Health Consortium (Pty) Ltd,,9.0,,,f,,,,f,f,f,,,f,,,,,,UNDECIDED,Data will be shared with callaborators.,2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,OTHER,,,,,,,2021,1.0
NCT02516696,,2015-08-04,2023-03-27,,2023-06-02,2015-08-05,2015-08-06,ESTIMATED,2023-06-02,2023-06-05,ACTUAL,,,,2023-06-02,2023-06-05,ACTUAL,2016-02,ACTUAL,2016-02-29,2023-06,2023-06-30,2022-07-22,ACTUAL,2022-07-22,2022-06-22,ACTUAL,2022-06-22,,INTERVENTIONAL,BiRd vs Rd,,BiRd vs. Rd as Initial Therapy in Multiple Myeloma,Lenalidomide and Dexamethasone (Rd) Versus Clarithromycin [Biaxin®] / Lenalidomide [Revlimid®] / Dexamethasone (BiRd) as Initial Therapy in Multiple Myeloma,TERMINATED,,PHASE3,12.0,ACTUAL,Weill Medical College of Cornell University,The significance of these results is limited by the study's low accrual. The study's low accrual was due in part to the COVID-19 pandemic.,2.0,,low enrollment,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,OTHER,,,,,,,2022,0.0
NCT02746952,,2016-03-07,,,2021-09-24,2016-04-18,2016-04-21,ESTIMATED,,,,,,,2021-09-24,2021-10-01,ACTUAL,2016-08-01,ACTUAL,2016-08-01,2021-09,2021-09-30,2020-07-28,ACTUAL,2020-07-28,2020-07-28,ACTUAL,2020-07-28,,INTERVENTIONAL,CALM,,Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukaemia,"Phase I, Open Label, Dose-escalation Study Followed by a Safety Expansion Part to Evaluate the Safety, Expansion and Persistence of a Single Dose of UCART19 (Allogeneic Engineered T-cells Expressing Anti-CD19 Chimeric Antigen Receptor), Administered Intravenously in Patients With Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukaemia (B-ALL)",COMPLETED,,PHASE1,25.0,ACTUAL,Servier,,1.0,,,f,,,,t,t,f,,,,,,After Marketing Authorisation in EEA or US if the study is used for the approval.,Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.,https://clinicaltrials.servier.com/,YES,"Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.",2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,INDUSTRY,,,,,,,2020,1.0
NCT05641545,,2022-05-02,,,2024-09-15,2022-11-30,2022-12-07,ACTUAL,,,,,,,2024-09-15,2024-09-19,ACTUAL,2022-10-17,ACTUAL,2022-10-17,2024-09,2024-09-30,2024-09-15,ACTUAL,2024-09-15,2024-09-15,ACTUAL,2024-09-15,,INTERVENTIONAL,,,IVAC-RCC-001: A Personalized Neoantigen Vaccine as Add-on to Standard of Care Checkpoint Inhibitor in Advanced/Metastatic RCC Patients,IVAC-RCC-001: A Personalized Neoantigen Vaccine as Add-on to Standard of Care Checkpoint Inhibitor in Advanced/Metastatic RCC Patients,TERMINATED,,PHASE1,1.0,ACTUAL,SLK Kliniken Heilbronn GmbH,,1.0,,Premature discontinuation due to üoor participant recruitment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,OTHER,,,,,,,2024,0.0
NCT04192500,,2019-12-03,,,2022-09-20,2019-12-06,2019-12-10,ACTUAL,,,,,,,2022-09-20,2022-09-22,ACTUAL,2019-12-11,ACTUAL,2019-12-11,2022-09,2022-09-30,2020-09-07,ACTUAL,2020-09-07,2020-09-07,ACTUAL,2020-09-07,,INTERVENTIONAL,,,"Safety and Immune Response of One Dose of OVX836 at Two Dose Levels, in Comparison to Influvac TetraTM, After Intramuscular Administration in Healthy Subjects Aged 18-65 Years","A Phase 2a, Single Center, Randomized, Double-blind, Controlled Study to Evaluate the Immunogenicity and the Safety of One Dose of OVX836 Influenza Vaccine at Two Dose Levels (90 µg and 180 μg), in Comparison to Influvac TetraTM, Quadrivalent Seasonal Influenza Sub-unit Vaccine, After Intramuscular Administration in Healthy Subjects Aged 18-65 Years",COMPLETED,,PHASE2,300.0,ACTUAL,Osivax,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,INDUSTRY,,,,,,,2020,1.0
NCT04591626,,2020-10-16,2023-04-27,,2023-04-27,2020-10-16,2020-10-19,ACTUAL,2023-04-27,2023-05-24,ACTUAL,,,,2023-04-27,2023-05-24,ACTUAL,2020-12-07,ACTUAL,2020-12-07,2023-04,2023-04-30,2022-04-28,ACTUAL,2022-04-28,2022-04-28,ACTUAL,2022-04-28,,INTERVENTIONAL,AWARD-CHN3,All randomized participants.,A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes,"A Randomized, Double-Blind Trial Comparing the Effect of the Addition of Dulaglutide 1.5 mg Versus the Addition of Placebo to Titrated Basal Insulin on Glycemic Control in Chinese Patients With Type 2 Diabetes",COMPLETED,,PHASE3,291.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 14:36:21.097932,2024-10-16 14:36:21.097932,INDUSTRY,,,,,,,2022,1.0
NCT04657679,,2020-11-20,,,2024-02-01,2020-12-01,2020-12-08,ACTUAL,,,,,,,2024-02-01,2024-02-05,ACTUAL,2021-05-20,ACTUAL,2021-05-20,2024-02,2024-02-29,2023-10-30,ACTUAL,2023-10-30,2023-10-30,ACTUAL,2023-10-30,,INTERVENTIONAL,LEANORA,,Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts,evaLuation of Variations pharmacokinEtics and phArmacogeNOmics of Ribociclib in rAce-based Cohorts: The LEANORA Study,TERMINATED,,PHASE4,21.0,ACTUAL,Georgetown University,,2.0,,Sufficient accrual into the African American/Black patient cohort and insufficient accrual into the NHW patient cohort.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,OTHER,,,,,,,2023,0.0
NCT04799158,,2021-03-11,2022-10-31,,2022-12-08,2021-03-11,2021-03-16,ACTUAL,2022-12-08,2023-01-04,ACTUAL,,,,2022-12-08,2023-01-04,ACTUAL,2021-03-25,ACTUAL,2021-03-25,2022-12,2022-12-31,2022-01-17,ACTUAL,2022-01-17,2021-12-16,ACTUAL,2021-12-16,,INTERVENTIONAL,,On-Demand Treatment Period: The Safety On-Demand Set included all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.,A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease,"A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg, 20 mg, and 40 mg Compared to Placebo for Relief of Episodic Heartburn in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease",COMPLETED,,PHASE2,458.0,ACTUAL,"Phathom Pharmaceuticals, Inc.",,5.0,,,f,,,,f,t,f,,,,,,,,,NO,"Data from this study will be published; however, it is undecided if patient level data will be made available at this time.",2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,INDUSTRY,,,,,,,2022,1.0
NCT04338126,,2020-04-06,,,2021-04-21,2020-04-06,2020-04-08,ACTUAL,,,,,,,2021-04-21,2021-04-23,ACTUAL,2021-09-30,ESTIMATED,2021-09-30,2021-04,2021-04-30,2021-12-31,ESTIMATED,2021-12-31,2021-12-15,ESTIMATED,2021-12-15,,INTERVENTIONAL,TCInpatient,,Tranexamic Acid (TXA) and Corona Virus 2019 (COVID19) in Inpatients,Exploratory Studies of the Effect of Tranexamic Acid Treatment on the Progression of COVID19 in Inpatients,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Alabama at Birmingham,,2.0,,"Due to ongoing vaccination efforts, feasibility for recruitment is low",f,,,,,t,f,,,,,,,,,NO,,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,OTHER,,,,,,,2021,0.0
NCT06056310,,2023-09-20,,,2024-09-10,2023-09-20,2023-09-28,ACTUAL,,,,,,,2024-09-10,2024-09-19,ACTUAL,2024-01-18,ACTUAL,2024-01-18,2024-09,2024-09-30,2024-08-20,ACTUAL,2024-08-20,2024-08-20,ACTUAL,2024-08-20,,INTERVENTIONAL,,,"Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)","A Single Arm, Open Label, Phase 1b Study of Xevinapant in Combination With Weekly Cisplatin and Intensity-modulated Radiotherapy to Assess Safety and Tolerability in Participants With LA SCCHN, Suitable for Definitive Chemoradiotherapy (HyperlynX)",TERMINATED,,PHASE1,18.0,ACTUAL,EMD Serono,,1.0,,"No major safety concerns were identified in HyperlynX study, but Lack of evidence of efficacy of meaningful clinical benefit.",f,,,,t,t,f,,,,,,,,,NO,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21",2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,INDUSTRY,,,,,,,2024,0.0
NCT04931667,,2021-06-04,,,2021-12-17,2021-06-11,2021-06-18,ACTUAL,,,,,,,2021-12-17,2022-01-10,ACTUAL,2021-07-15,ACTUAL,2021-07-15,2021-12,2021-12-31,2021-12-13,ACTUAL,2021-12-13,2021-12-13,ACTUAL,2021-12-13,,INTERVENTIONAL,,,"3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Subjects With Osteoarthritis of the Knee","A 3-Year, Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Intra-articular Lorecivivint in Subjects With Osteoarthritis of the Knee in a Real-World Setting (STRIDES-EXTRA)",TERMINATED,,PHASE3,73.0,ACTUAL,"Biosplice Therapeutics, Inc.",,1.0,,Study was terminated due to business reasons by Sponsor.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,INDUSTRY,,,,,,,2021,0.0
NCT03618953,,2018-06-22,,,2023-04-11,2018-08-01,2018-08-07,ACTUAL,,,,,,,2023-04-11,2023-04-14,ACTUAL,2018-06-21,ACTUAL,2018-06-21,2023-04,2023-04-30,2021-03-05,ACTUAL,2021-03-05,2021-03-05,ACTUAL,2021-03-05,,INTERVENTIONAL,Kingfisher,,This is a Trial of MG1-E6E7 With Ad-E6E7 and Atezolizumab in Patients With HPV Associated Cancers,"Phase 1/1b, Multicenter, Open-label Trial of Oncolytic MG1 Virus (MG1-E6E7) With Adenovirus Vaccine (Ad-E6E7) Both Expressing Mutant Human Papilloma Virus (HPV) E6 and E7 and Atezolizumab in Pts With HPV Assoc. Cancers",TERMINATED,,PHASE1,8.0,ACTUAL,"Turnstone Biologics, Corp.",,2.0,,Virus potency titer of drug product as determined by an improved potency assay was lower than originally determined by the assay described in the IND.,f,,,,,t,f,,,,,,,,,,,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,INDUSTRY,,,,,,,2021,0.0
NCT06422377,,2024-05-15,,,2024-09-13,2024-05-15,2024-05-21,ACTUAL,,,,,,,2024-09-13,2024-09-19,ACTUAL,2024-04-25,ACTUAL,2024-04-25,2024-09,2024-09-30,2024-08-14,ACTUAL,2024-08-14,2024-08-14,ACTUAL,2024-08-14,,INTERVENTIONAL,,,A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine,"An Open-label, Nonrandomized, Phase 3 Study to Evaluate the Efficacy and Safety of Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine",TERMINATED,,PHASE3,1.0,ACTUAL,Takeda,,1.0,,Business decision unrelated to patient safety.,f,,,,,t,f,,,f,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,INDUSTRY,,,,,,,2024,0.0
NCT02767232,,2015-12-16,,,2018-08-08,2016-05-06,2016-05-10,ESTIMATED,,,,,,,2018-08-08,2018-08-10,ACTUAL,2018-07,ESTIMATED,2018-07-31,2018-08,2018-08-31,2023-06,ESTIMATED,2023-06-30,2023-04,ESTIMATED,2023-04-30,,INTERVENTIONAL,PHLO,,Pediatric High-Risk Deep Venous Thrombosis Lytic Outcomes Trial,Pediatric High-Risk Deep Venous Thrombosis Lytic Outcomes Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,"University of Colorado, Denver",,2.0,,Did not receive NIH Funding,f,,,,t,t,f,,,,,,,,,,,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,OTHER,,,,,,,2023,0.0
NCT04351516,,2020-04-15,,,2021-01-12,2020-04-16,2020-04-17,ACTUAL,,,,,,,2021-01-12,2021-01-15,ACTUAL,2020-04-21,ACTUAL,2020-04-21,2020-04,2020-04-30,2021-05-01,ESTIMATED,2021-05-01,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,COVID65plus,,Test and Treat COVID 65plus+,Randomized Controlled Trial of Hydroxychloroquine Versus Placebo in Early Ambulatory Diagnosis and Treatment of Elderly COVID19 Patients,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,University Hospital Tuebingen,,2.0,,No Patients enrolled,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,OTHER,,,,,,,2021,0.0
NCT04276883,,2020-02-18,2023-08-08,,2023-08-30,2020-02-18,2020-02-19,ACTUAL,2023-08-30,2023-09-11,ACTUAL,,,,2023-08-30,2023-09-11,ACTUAL,2020-02-24,ACTUAL,2020-02-24,2023-08,2023-08-31,2020-05-21,ACTUAL,2020-05-21,2020-05-21,ACTUAL,2020-05-21,,INTERVENTIONAL,SERENITY II,Safety population (all participants who received study drug),Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder,"A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine Efficacy and Safety of BXCL501 In Agitation Associated With Bipolar Disorder",COMPLETED,,PHASE3,380.0,ACTUAL,BioXcel Therapeutics Inc,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,INDUSTRY,,,,,,,2020,1.0
NCT03265080,,2017-07-12,,,2023-02-22,2017-08-28,2017-08-29,ACTUAL,,,,,,,2023-02-22,2023-02-24,ACTUAL,2018-03-28,ACTUAL,2018-03-28,2023-02,2023-02-28,2020-11-12,ACTUAL,2020-11-12,2019-10-24,ACTUAL,2019-10-24,,INTERVENTIONAL,NEO,,A Study of ADXS-NEO Expressing Personalized Tumor Antigens,"A Phase 1 Dose-Escalation Study of ADXS-NEO Expressing Personalized Tumor Antigens, Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors",TERMINATED,,PHASE1,13.0,ACTUAL,"Advaxis, Inc.",,3.0,,Business decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,INDUSTRY,,,,,,,2020,0.0
NCT02329756,,2014-12-29,,,2018-08-21,2014-12-30,2015-01-01,ESTIMATED,,,,,,,2018-08-21,2018-08-23,ACTUAL,2018-12,ESTIMATED,2018-12-31,2018-08,2018-08-31,2021-12,ESTIMATED,2021-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Tranexamic Acid in Adherent Placenta (TAP),"Tranexamic Acid in Adherent Placenta (TAP), a Randomized Clinical Trial",WITHDRAWN,,PHASE3,0.0,ACTUAL,Baylor College of Medicine,,2.0,,More preparation needed prior to collecting data.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,OTHER,,,,,,,2021,0.0
NCT02753283,,2016-04-25,2024-08-23,,2024-08-27,2016-04-25,2016-04-27,ESTIMATED,2024-08-27,2024-09-19,ACTUAL,,,,2024-08-27,2024-09-19,ACTUAL,2016-06,ACTUAL,2016-06-30,2024-08,2024-08-31,2023-08,ACTUAL,2023-08-31,2023-08,ACTUAL,2023-08-31,,INTERVENTIONAL,PROUD,,Preventing Osteoporosis Using Denosumab,Sustaining Skeletal Health in Frail Elderly,COMPLETED,,PHASE4,201.0,ACTUAL,University of Pittsburgh,,4.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,OTHER,,,,,,,2023,1.0
NCT03605238,,2018-06-29,,,2019-09-17,2018-07-21,2018-07-30,ACTUAL,,,,,,,2019-09-17,2019-09-19,ACTUAL,2018-08-15,ESTIMATED,2018-08-15,2019-08,2019-08-31,2020-08-15,ESTIMATED,2020-08-15,2019-08-15,ESTIMATED,2019-08-15,,INTERVENTIONAL,,,Treatment of Relapsed and/or Refractory AQP4-IgG Seropositive NMOSD by Tandem CAR T Cells Targeting CD19 and CD20,Clinical Study of CD19/CD20 tanCAR T Cells in Relapsed and/or Refractory AQP4-IgG Seropositive Neuromyelitis Optica Spectrum Disorders (NMOSD),WITHDRAWN,,PHASE1,0.0,ACTUAL,Chinese PLA General Hospital,,1.0,,It was hard to recruit patients,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,OTHER,,,,,,,2020,0.0
NCT03601637,,2018-07-18,2022-10-28,,2022-12-14,2018-07-18,2018-07-26,ACTUAL,2022-12-14,2023-01-06,ACTUAL,,,,2022-12-14,2023-01-06,ACTUAL,2018-09-07,ACTUAL,2018-09-07,2022-12,2022-12-31,2021-10-29,ACTUAL,2021-10-29,2021-10-29,ACTUAL,2021-10-29,,INTERVENTIONAL,,"All participants who received at least one dose of the study drug during the treatment period were included in the baseline analysis. The baseline analysis was collected for the overall treatment arm, irrespective of a weight-based dose regimen. Therefore, the analysis is reported in a single arm for each study part (Part A: LUM/IVA and Part B: LUM/IVA).","Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del","A Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del",COMPLETED,,PHASE3,61.0,ACTUAL,Vertex Pharmaceuticals Incorporated,,2.0,,,,,,,t,t,f,,,,,,,,,NO,Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,INDUSTRY,,,,,,,2021,1.0
NCT02030184,,2014-01-06,,,2019-10-15,2014-01-07,2014-01-08,ESTIMATED,,,,,,,2019-10-15,2019-10-17,ACTUAL,2017-06,ESTIMATED,2017-06-30,2019-10,2019-10-31,2021-06,ESTIMATED,2021-06-30,2019-06,ESTIMATED,2019-06-30,,INTERVENTIONAL,,,Phase I/II Trial of Rhenium 188-P2045 in Small Cell Lung Cancer and Other Advanced Neuroendocrine Carcinomas,Phase I/II Dose Escalation Trial of Rhenium 188-P2045 in Small Cell Lung Cancer and Other Advanced Neuroendocrine Carcinomas as a Single Agent and in Combination With Topotecan,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"University of Maryland, Baltimore",,1.0,,PI has left the study institution.,f,,,,t,t,f,,,,,,,,,,,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,OTHER,,,,,,,2021,0.0
NCT03340727,,2017-11-03,2024-05-07,,2024-07-30,2017-11-08,2017-11-13,ACTUAL,2024-06-04,2024-06-28,ACTUAL,,,,2024-07-30,2024-07-31,ACTUAL,2019-02-27,ACTUAL,2019-02-27,2024-07,2024-07-31,2023-03-20,ACTUAL,2023-03-20,2023-01-23,ACTUAL,2023-01-23,,INTERVENTIONAL,MoCHA,The study recruited infants based on eligibility and parental/guardian consent. Baseline characteristics of the mother were collected (with consent) for use in statistical analysis.,Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial,Randomized Controlled Trial of Home Therapy With Caffeine Citrate in Moderately Preterm Infants With Apnea of Prematurity,TERMINATED,,PHASE3,827.0,ACTUAL,NICHD Neonatal Research Network,,2.0,,Futility,f,,,,t,t,f,,,,,,,,,YES,Per NIH Data Sharing Plan,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,NETWORK,,,,,,,2023,0.0
NCT03432897,,2017-10-05,2022-01-05,,2022-02-02,2018-02-13,2018-02-14,ACTUAL,2022-01-05,2022-02-03,ACTUAL,,,,2022-02-02,2022-02-23,ACTUAL,2018-05-25,ACTUAL,2018-05-25,2022-02,2022-02-28,2021-12-07,ACTUAL,2021-12-07,2020-12-15,ACTUAL,2020-12-15,,INTERVENTIONAL,337,,BrUOG 337: Olaparib Prior to Radical Prostatectomy For Advanced Prostate Cancer Defects in DNA Repair Genes,BrUOG 337: Olaparib Prior to Radical Prostatectomy For Patients With Locally Advanced Prostate Cancer and Defects in DNA Repair Genes,TERMINATED,,PHASE2,1.0,ACTUAL,Brown University,,1.0,,Lack of enrollment secondary to eligibility criteria,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,OTHER,,,,,,,2021,0.0
NCT03150836,,2017-05-10,,,2017-10-17,2017-05-10,2017-05-12,ACTUAL,,,,,,,2017-10-17,2017-10-19,ACTUAL,2017-10-01,ESTIMATED,2017-10-01,2017-10,2017-10-31,2024-09-01,ESTIMATED,2024-09-01,2021-09-01,ESTIMATED,2021-09-01,,INTERVENTIONAL,,,"Radiation Therapy and Durvalumab, With or Without Tremelimumab, in Patients With Bladder Cancer","Multi-Institutional Phase II Study of Radiation Therapy and Anti-PD-L1 Checkpoint Inhibition (Durvalumab) With or Without Anti-CTLA-4 Inhibition (Tremelimumab) in Patients With Unresectable, Muscle-Invasive or Metastatic Urothelial Bladder Cancer That Are Ineligible or Refusing Chemotherapy",WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, San Francisco",,6.0,,Co-PI Albert Chang relocating to UCLA. IND will transfer to UCLA. UCSF will not participate.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,OTHER,,,,,,,2024,0.0
NCT05148195,,2021-11-15,,,2024-03-10,2021-11-24,2021-12-08,ACTUAL,,,,,,,2024-03-10,2024-03-13,ACTUAL,2021-12-22,ACTUAL,2021-12-22,2022-04,2022-04-30,2023-07-26,ACTUAL,2023-07-26,2023-07-26,ACTUAL,2023-07-26,,INTERVENTIONAL,,,A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors,"An Open Label, Multi-cohort, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Envofolimab in Combination With BD0801 Injection With/Without Chemotherapy in Patients With Advanced Solid Tumors",TERMINATED,,PHASE2,86.0,ACTUAL,"Jiangsu Simcere Pharmaceutical Co., Ltd.",,4.0,,The study was terminated due to the sponsor's research and development strategy adjustment.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,INDUSTRY,,,,,,,2023,0.0
NCT04668339,,2020-11-25,,,2022-07-07,2020-12-10,2020-12-16,ACTUAL,,,,,,,2022-07-07,2022-07-08,ACTUAL,2021-01-07,ACTUAL,2021-01-07,2022-07,2022-07-31,2022-03-01,ACTUAL,2022-03-01,2022-03-01,ACTUAL,2022-03-01,,INTERVENTIONAL,,,A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults,"A Phase 2 Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Safety, Reactogenicity, and Immunogenicity of the SARS CoV-2 Vaccine ARCT-021 in Healthy Adult Participants",TERMINATED,,PHASE2,581.0,ACTUAL,"Arcturus Therapeutics, Inc.",,8.0,,A decision was made to terminate the study for operational/business reasons. The study was not terminated for reasons of safety or immunogenicity.,f,,,,t,t,f,,,,,,,,,NO,Individual participant data will only be made available to study investigators at this time.,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,INDUSTRY,,,,,,,2022,0.0
NCT02924038,,2016-05-12,2024-05-16,,2024-06-12,2016-10-04,2016-10-05,ESTIMATED,2024-06-12,2024-06-14,ACTUAL,,,,2024-06-12,2024-06-14,ACTUAL,2017-04-03,ACTUAL,2017-04-03,2024-06,2024-06-30,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG),Pilot Randomized Neo-adjuvant Evaluation of Agonist Anti-CD27 Monoclonal Antibody Varlilumab on Immunologic Activities of IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG),TERMINATED,,PHASE1,14.0,ACTUAL,"University of California, San Francisco","Enrollment was closed earlier than expected due to industry sponsor's prioritization of other programs, the termination of Varliumab development, and Coronavirus disease of 2019 (COVID-19) related challenges during the period of enrollment. Appropriate reagents were not available for the CD4+ outcome measure. Due to the small number of participants, the biological/immunological evaluations are insufficiently powered to provide meaningful statistical significance.",2.0,,Industry sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,OTHER,,,,,,,2022,0.0
NCT04915352,,2021-05-21,,,2024-08-07,2021-05-31,2021-06-07,ACTUAL,,,,,,,2024-08-07,2024-08-09,ACTUAL,2022-03-07,ACTUAL,2022-03-07,2024-08,2024-08-31,2024-07-05,ACTUAL,2024-07-05,2024-07-05,ACTUAL,2024-07-05,,INTERVENTIONAL,NPT-MAR,,Interest of Nasal Provocation Tests for Diagnosis of House Mites Allergic Rhinitis,Interest of Nasal Provocation Tests for Diagnosis of House Mites Allergic Rhinitis,TERMINATED,,PHASE4,8.0,ACTUAL,Centre Hospitalier Régional Metz-Thionville,,1.0,,The study is terminated because the product (nasal provocation test) is out of stock.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 14:41:58.898016,2024-10-16 14:41:58.898016,OTHER,,,,,,,2024,0.0
NCT03542812,,2018-05-02,2023-10-23,,2024-05-28,2018-05-18,2018-05-31,ACTUAL,2024-04-24,2024-05-02,ACTUAL,,,,2024-05-28,2024-06-10,ACTUAL,2019-07-30,ACTUAL,2019-07-30,2024-05,2024-05-31,2022-08-31,ACTUAL,2022-08-31,2022-08-31,ACTUAL,2022-08-31,,INTERVENTIONAL,,,L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia,Pharmacokinetics of L-citrulline in Infants at High Risk of Developing Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia,TERMINATED,,EARLY_PHASE1,16.0,ACTUAL,University of Utah,"The study was terminated prior to full enrollment goals of group 3 (steady-state group), therefore there was a small number of subjects for analysis.",2.0,,The study stopped enrollment prior to the initially projected 18 subjects per phase due to lack of funding to continue to recertify the drug and because an adequate number of subjects were enrolled for each phase to analyze pharmacokinetics.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,OTHER,,,,,,,2022,0.0
NCT03196947,,2017-05-19,,,2020-01-28,2017-06-20,2017-06-23,ACTUAL,,,,,,,2020-01-28,2020-01-30,ACTUAL,2017-06-13,ACTUAL,2017-06-13,2020-01,2020-01-31,2020-01-16,ACTUAL,2020-01-16,2020-01-16,ACTUAL,2020-01-16,,INTERVENTIONAL,SMR-3184,,Safety and Pharmacokinetics of Rising Doses of APO010 in Relapsed/Refractory Multiple Myeloma Patients Selected by DRP,"Phase I, Open Label, Dose Escalation Study to Investigate the Tolerability and Efficacy of APO010 in Patients With Relapsed/Refractory Multiple Myeloma Selected by Drug Response Predictor (DRP)",TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,Allarity Therapeutics,,1.0,,The study was terminated early due to sponsors decision,f,,,,t,f,f,,,,,,,,,,,2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,INDUSTRY,,,,,,,2020,0.0
NCT02684578,,2016-02-09,2023-04-13,,2023-05-16,2016-02-11,2016-02-18,ESTIMATED,2023-05-16,2023-06-09,ACTUAL,,,,2023-05-16,2023-06-09,ACTUAL,2016-04,,2016-04-30,2023-05,2023-05-31,2022-10,ACTUAL,2022-10-31,2022-04,ACTUAL,2022-04-30,,INTERVENTIONAL,METforMIN,,Metformin for the Minimization of Geographic Atrophy Progression in Patients With AMD,METforMIN: Metformin Administration for the Minimization of Geographic Atrophy Progression in Patients With Age-related Macular Degeneration,COMPLETED,,PHASE2,66.0,ACTUAL,"University of California, San Francisco",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,OTHER,,,,,eyes,,2022,1.0
NCT04646109,,2020-11-15,2020-12-03,,2021-01-25,2020-11-25,2020-11-27,ACTUAL,2021-01-25,2021-01-27,ACTUAL,,,,2021-01-25,2021-01-27,ACTUAL,2020-05-11,ACTUAL,2020-05-11,2021-01,2021-01-31,2020-09-02,ACTUAL,2020-09-02,2020-09-02,ACTUAL,2020-09-02,,INTERVENTIONAL,,"36 patients were included in the study group. But, 6 patients in the study group were excluded from the study and analysis because ivermectin treatments were terminated due to the detection of a mutation that impairs ivermectin metabolism. As a result, overall number of baseline participants in the study group was 30.",Ivermectin for Severe COVID-19 Management,The Effectiveness and Safety of Ivermectin as add-on Therapy in Severe COVID-19 Management,COMPLETED,,PHASE3,66.0,ACTUAL,Afyonkarahisar Health Sciences University,,2.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,OTHER,,,,,,,2020,1.0
NCT03933956,,2019-04-20,,,2020-12-13,2019-04-28,2019-05-01,ACTUAL,,,,,,,2020-12-13,2020-12-17,ACTUAL,2020-01-09,ACTUAL,2020-01-09,2020-12,2020-12-31,2020-08-01,ACTUAL,2020-08-01,2020-08-01,ACTUAL,2020-08-01,,INTERVENTIONAL,(MEDiaN),,Metabolic Effects of the SGLT-2 Inhibitor Empagliflozin in Patients With Diabetic Nephropathy (MEDiaN),Metabolic Effects of the SGLT-2 Inhibitor Empagliflozin in Patients With Diabetic Nephropathy (MEDiaN),TERMINATED,,PHASE3,2.0,ACTUAL,Singapore General Hospital,,1.0,,Study terminated owing to challenges posed by the COVID-19 situation.,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,OTHER,,,,,,,2020,0.0
NCT01860976,,2013-05-21,2017-07-10,2016-06-03,2022-03-14,2013-05-21,2013-05-23,ESTIMATED,2017-07-10,2017-08-02,ACTUAL,2016-06-03,2016-06-07,ESTIMATED,2022-03-14,2022-04-05,ACTUAL,2013-06-17,ACTUAL,2013-06-17,2022-03,2022-03-31,2020-06-30,ACTUAL,2020-06-30,2015-07-14,ACTUAL,2015-07-14,,INTERVENTIONAL,ASTRAEA,All randomized participants,Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Psoriatic Arthritis,A Phase 3 Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Subcutaneous Injection in Adults With Active Psoriatic Arthritis,COMPLETED,,PHASE3,489.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,INDUSTRY,,,,,,,2020,1.0
NCT03897088,,2019-03-27,2023-02-01,,2023-05-28,2019-03-28,2019-04-01,ACTUAL,2023-05-28,2023-05-31,ACTUAL,,,,2023-05-28,2023-05-31,ACTUAL,2019-03-29,ACTUAL,2019-03-29,2022-05,2022-05-31,2022-02-17,ACTUAL,2022-02-17,2022-02-17,ACTUAL,2022-02-17,,INTERVENTIONAL,,,Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasis,"A Multicenter, Randomized, Double Blind, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Plaque Psoriasis of the Scalp",COMPLETED,,PHASE3,231.0,ACTUAL,Sun Pharmaceutical Industries Limited,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,INDUSTRY,,,,,,,2022,1.0
NCT03486912,,2018-03-30,2022-08-22,2021-07-09,2022-10-11,2018-03-30,2018-04-03,ACTUAL,2022-10-11,2022-10-13,ACTUAL,2022-10-11,2022-10-13,ACTUAL,2022-10-11,2022-10-13,ACTUAL,2018-06-12,ACTUAL,2018-06-12,2022-10,2022-10-31,2021-09-14,ACTUAL,2021-09-14,2020-10-08,ACTUAL,2020-10-08,,INTERVENTIONAL,FALCON 2,,A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis,"A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults With Nonalcoholic Steatohepatitis (NASH) and Compensated Liver Cirrhosis",COMPLETED,,PHASE2,155.0,ACTUAL,Bristol-Myers Squibb,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,INDUSTRY,,,,,,,2021,1.0
NCT03096834,,2017-03-17,2022-01-25,2019-09-16,2022-02-23,2017-03-24,2017-03-30,ACTUAL,2022-01-25,2022-02-18,ACTUAL,2019-09-20,2019-10-04,ACTUAL,2022-02-23,2022-03-23,ACTUAL,2017-03-20,ACTUAL,2017-03-20,2022-02,2022-02-28,2021-01-28,ACTUAL,2021-01-28,2018-01-18,ACTUAL,2018-01-18,,INTERVENTIONAL,,,A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies,"A 12-week Double-blind, Randomized, Multicenter Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous 140 mg AMG 334 Against Placebo in Adult Episodic Migraine Patients Who Have Failed 2-4 Prophylactic Treatments (LIBERTY)",COMPLETED,,PHASE3,246.0,ACTUAL,Novartis,,4.0,,,f,,,,f,t,f,,,t,,,,,http://www.clinicalstudydatarequest.com,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,INDUSTRY,,,,,,,2021,1.0
NCT04154033,,2019-11-04,,,2021-04-15,2019-11-04,2019-11-06,ACTUAL,,,,,,,2021-04-15,2021-04-20,ACTUAL,2020-10-01,ESTIMATED,2020-10-01,2021-04,2021-04-30,2024-03-31,ESTIMATED,2024-03-31,2024-03-31,ESTIMATED,2024-03-31,,INTERVENTIONAL,,,Treatment of Chronic Itch in Atopic Dermatitis With Topical Naltrexone,Treatment of Chronic Itch in Atopic Dermatitis With Topical Naltrexone as Well as the Influence of Circadian Rhythm,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Minnesota,,3.0,,Funding,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,OTHER,,,,,,,2024,0.0
NCT04659109,,2020-11-30,,,2021-09-10,2020-12-07,2020-12-09,ACTUAL,,,,,,,2021-09-10,2021-09-13,ACTUAL,2020-12-16,ACTUAL,2020-12-16,2021-09,2021-09-30,2021-08-06,ACTUAL,2021-08-06,2021-08-06,ACTUAL,2021-08-06,,INTERVENTIONAL,GARDEN,,Glenzocimab in SARS-Cov-2 Acute Respiratory DistrEss syNdrome Related to COVID-19,"A Randomized, Double Blind, Multicenter, Placebo Controlled, Parallel Group, Exploratory Efficacy and Safety Study of Glenzocimab in SARS-Cov-2-related Acute Respiratory Distress Syndrome",COMPLETED,,PHASE2,60.0,ACTUAL,Acticor Biotech,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,INDUSTRY,,,,,,,2021,0.0
NCT03328936,,2017-10-03,,,2020-02-19,2017-10-31,2017-11-01,ACTUAL,,,,,,,2020-02-19,2020-02-21,ACTUAL,2018-09-01,ESTIMATED,2018-09-01,2020-02,2020-02-29,2021-03-31,ESTIMATED,2021-03-31,2021-03-31,ESTIMATED,2021-03-31,,INTERVENTIONAL,,,Study of Personalized Melphalan Dosing in the Setting of Autologous Transplant,Randomized Study of Personalized Melphalan Dosing in the Setting of Autologous Transplant,WITHDRAWN,,PHASE2,0.0,ACTUAL,Ohio State University Comprehensive Cancer Center,,2.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,OTHER,,,,,,,2021,0.0
NCT05193279,,2021-12-23,,,2023-03-22,2022-01-11,2022-01-14,ACTUAL,,,,,,,2023-03-22,2023-03-24,ACTUAL,2022-10-05,ACTUAL,2022-10-05,2023-03,2023-03-31,2022-12-15,ACTUAL,2022-12-15,2022-12-15,ACTUAL,2022-12-15,,INTERVENTIONAL,,,Safety and Immunogenicity of SCB-2019 in Children <18 Years of Age,"A Randomized, Controlled, Dose-finding, Observer-blind, Phase 2/3 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of CpG/Alum-adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccines (SCB-2019 Vaccine) in Children <18 Years of Age",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Clover Biopharmaceuticals AUS Pty Ltd,,21.0,,The study was terminated during the EC submission process prior to the enrollment.,f,,,,t,f,f,,,,,,,,,,,2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,INDUSTRY,,,,,,,2022,0.0
NCT03151057,,2017-03-29,2023-08-15,,2023-08-16,2017-05-10,2017-05-12,ACTUAL,2023-08-16,2024-03-12,ACTUAL,,,,2023-08-16,2024-03-12,ACTUAL,2018-07-31,ACTUAL,2018-07-31,2023-08,2023-08-31,2022-07-20,ACTUAL,2022-07-20,2022-06-20,ACTUAL,2022-06-20,,INTERVENTIONAL,,,Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies,Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies: A Phase 1 Double Blinded Randomized Placebo Toxicity Trial,TERMINATED,,PHASE1,16.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,2.0,,Safety endpointreached,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,OTHER,,,,,,,2022,0.0
NCT04084483,,2019-08-13,2023-01-03,2021-01-04,2023-02-16,2019-09-09,2019-09-10,ACTUAL,2023-02-16,2023-03-15,ACTUAL,,2023-03-15,ACTUAL,2023-02-16,2023-03-15,ACTUAL,2019-08-04,ACTUAL,2019-08-04,2023-02,2023-02-28,2020-01-09,ACTUAL,2020-01-09,2020-01-09,ACTUAL,2020-01-09,,INTERVENTIONAL,,,"A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease","A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease",COMPLETED,,PHASE2,238.0,ACTUAL,"Kowa Research Institute, Inc.",,4.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,INDUSTRY,,,,,,,2020,1.0
NCT04335578,,2020-04-03,,,2022-09-16,2020-04-03,2020-04-06,ACTUAL,,,,,,,2022-09-16,2022-09-21,ACTUAL,2019-10-21,ACTUAL,2019-10-21,2022-09,2022-09-30,2022-05-04,ACTUAL,2022-05-04,2022-05-04,ACTUAL,2022-05-04,,INTERVENTIONAL,,,"A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury","A Multicenter, Randomized, Placebo-Controlled Investigator-Blind, Participant-Blind Study to Evaluate Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury",TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,UCB Pharma,,2.0,,Recruitment challenges,f,,,,f,f,f,,,,,,,,,NO,"Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.",2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,INDUSTRY,,,,,,,2022,0.0
NCT04642950,,2020-11-19,2023-04-24,,2024-02-06,2020-11-19,2020-11-24,ACTUAL,2024-02-06,2024-07-19,ACTUAL,,,,2024-02-06,2024-07-19,ACTUAL,2020-12-17,ACTUAL,2020-12-17,2021-11,2021-11-30,2021-10-25,ACTUAL,2021-10-25,2021-10-25,ACTUAL,2021-10-25,,INTERVENTIONAL,,,A Phase II/III Study of Sargramostim,A Phase II/III Study of Sargramostim in Patients With Coronavirus Disease-2019 (COVID-19),COMPLETED,,PHASE2/PHASE3,70.0,ACTUAL,Nobelpharma,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,INDUSTRY,,,,,,,2021,1.0
NCT02920996,,2016-09-29,2023-12-20,,2024-03-15,2016-09-29,2016-09-30,ESTIMATED,2024-03-15,2024-04-11,ACTUAL,,,,2024-03-15,2024-04-11,ACTUAL,2016-11-11,ACTUAL,2016-11-11,2024-03,2024-03-31,2023-10,ACTUAL,2023-10-31,2021-10,ACTUAL,2021-10-31,,INTERVENTIONAL,,No patient was accrued in the solid tumor arm.,Merestinib In Non-Small Cell Lung Cancer And Solid Tumors,A Phase II Study of Merestinib in Non-Small Cell Lung Cancers Harboring MET Exon 14 Mutations and Solid Tumors With NTRK Rearrangements,TERMINATED,,PHASE2,12.0,ACTUAL,Dana-Farber Cancer Institute,,2.0,,Funding was pulled,f,,,,t,,,,,,,,,,,NO,,2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,OTHER,,,,,,,2023,0.0
NCT02927301,,2016-10-05,2021-04-23,,2024-08-16,2016-10-05,2016-10-07,ESTIMATED,2021-04-23,2021-05-17,ACTUAL,,,,2024-08-16,2024-09-19,ACTUAL,2017-04-20,ACTUAL,2017-04-20,2024-08,2024-08-31,2023-09-05,ACTUAL,2023-09-05,2020-05-07,ACTUAL,2020-05-07,,INTERVENTIONAL,,Safety population included all enrolled participants who have received any dose of study drug.,A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3),"A Phase II, Open-Label, Multicenter, Single-Arm Study to Investigate the Efficacy and Safety of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Patients With Stage IB, II, IIIA, or Selected IIIB Resectable and Untreated Non-Small Cell Lung Cancer",COMPLETED,,PHASE2,181.0,ACTUAL,"Genentech, Inc.",,1.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,INDUSTRY,,,,,,,2023,1.0
NCT04712071,,2020-11-12,,,2022-02-16,2021-01-14,2021-01-15,ACTUAL,,,,,,,2022-02-16,2022-03-03,ACTUAL,2021-02-01,ACTUAL,2021-02-01,2022-02,2022-02-28,2022-02-16,ACTUAL,2022-02-16,2022-02-16,ACTUAL,2022-02-16,,INTERVENTIONAL,,,Ketamine in Veterans With Gulf War Illness,Effects of a Single Dose of Intravenous Ketamine on Symptoms of Gulf War Illness in 1990-1991 Gulf War Veterans,TERMINATED,,EARLY_PHASE1,1.0,ACTUAL,Baylor College of Medicine,,1.0,,Due to the COVID pandemic we could not enroll more than one subject before funding was ending.,f,,,,t,t,f,,,f,,,,,,NO,"We have not decided yet what the best way is to share the data. The data will become available, though.",2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,OTHER,,,,,,,2022,0.0
NCT03472365,,2018-03-14,2023-04-04,,2023-04-04,2018-03-14,2018-03-21,ACTUAL,2023-04-04,2024-01-11,ACTUAL,,,,2023-04-04,2024-01-11,ACTUAL,2018-04-02,ACTUAL,2018-04-02,2023-04,2023-04-30,2020-11-25,ACTUAL,2020-11-25,2020-11-25,ACTUAL,2020-11-25,,INTERVENTIONAL,,,A Study of SHR-1210 in Combination With Capecitabine + Oxaliplatin or Apatinib in Treatment of Advanced Gastric Cancer,A Randomized Phase 2 Study to Evaluate Safety and Efficacy of the Combination of SHR-1210 With Capecitabine + Oxaliplatin or Apatinib as First-line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma,COMPLETED,,PHASE2,67.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,2.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 14:47:34.008826,2024-10-16 14:47:34.008826,INDUSTRY,,,,,,,2020,1.0
NCT03627091,,2018-07-24,2022-03-03,,2022-03-03,2018-08-09,2018-08-13,ACTUAL,2022-03-03,2022-03-31,ACTUAL,,,,2022-03-03,2022-03-31,ACTUAL,2019-02-06,ACTUAL,2019-02-06,2022-03,2022-03-31,2021-09-13,ACTUAL,2021-09-13,2021-06-21,ACTUAL,2021-06-21,,INTERVENTIONAL,CARMEN CD 307,The safety set consisted of all participants who have received at least one dose of investigational product (IP) in the SHP647-307 study regardless of treatment received during the induction studies (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]).,Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307),"A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307)",TERMINATED,,PHASE3,40.0,ACTUAL,Takeda,The study was closed early as the sponsor discontinued the ontamalimab clinical trial program in CD for reasons unrelated to safety or efficacy.,3.0,,Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.,f,,,,t,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,INDUSTRY,,,,,,,2021,0.0
NCT05170009,,2021-12-09,,,2024-08-02,2021-12-09,2021-12-27,ACTUAL,,,,,,,2024-08-02,2024-08-07,ACTUAL,2022-04-22,ACTUAL,2022-04-22,2024-08,2024-08-31,2024-02-07,ACTUAL,2024-02-07,2024-01-17,ACTUAL,2024-01-17,,INTERVENTIONAL,,,Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza,"Randomized Double-blind, Placebo-controlled Single Center Pilot Study to Evaluate the Efficacy and Safety of Baloxavir in Combination With Oseltamivir in Adult Allogeneic Bone Marrow Transplant Recipients With Influenza",TERMINATED,,PHASE2/PHASE3,2.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,Slow enrollment rate,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,OTHER,,,,,,,2024,0.0
NCT04869982,,2021-04-28,2024-04-17,,2024-04-17,2021-04-28,2021-05-03,ACTUAL,2024-04-17,2024-09-19,ACTUAL,,,,2024-04-17,2024-09-19,ACTUAL,2021-05-14,ACTUAL,2021-05-14,2024-04,2024-04-30,2023-04-20,ACTUAL,2023-04-20,2023-04-20,ACTUAL,2023-04-20,,INTERVENTIONAL,,,"Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years","A Phase IV, Randomized, Observer-blind, Placebo-controlled, Multi-center Study to Assess the Prophylactic Efficacy Against Herpes Zoster, Immunogenicity and Safety of Shingrix When Administered Intramuscularly on a 2-dose Schedule in Chinese Adults Aged 50 Years and Older",COMPLETED,,PHASE4,6138.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,f,f,f,,,f,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,INDUSTRY,,,,,,,2023,1.0
NCT02939807,,2016-10-12,,,2024-09-11,2016-10-18,2016-10-20,ESTIMATED,,,,,,,2024-09-11,2024-09-19,ACTUAL,2019-09-30,ACTUAL,2019-09-30,2024-09,2024-09-30,2024-01-30,ESTIMATED,2024-01-30,2023-09-30,ACTUAL,2023-09-30,,INTERVENTIONAL,,,A Phase II Study of ABC294640 As Monotherapy in Patients with Advanced Hepatocellular Carcinoma,A Phase II Study of ABC294640 in Patients with Advanced Hepatocellular Carcinoma Who Have Progressed on Sorafenib,WITHDRAWN,,PHASE2,0.0,ACTUAL,Medical University of South Carolina,,1.0,,study is being rewritten for different disease population,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,OTHER,,,,,,,2024,0.0
NCT02834611,,2016-07-11,,,2024-05-27,2016-07-12,2016-07-15,ESTIMATED,,,,,,,2024-05-27,2024-05-29,ACTUAL,2017-03-15,ACTUAL,2017-03-15,2024-05,2024-05-31,2023-11-01,ACTUAL,2023-11-01,2023-08-03,ACTUAL,2023-08-03,,INTERVENTIONAL,,,Ceramide NanoLiposome in Patients With Advanced Solid Tumors,Phase I Study of C6 Ceramide NanoLiposome in Patients With Advanced Solid Tumors,COMPLETED,,PHASE1,14.0,ACTUAL,"Keystone Nano, Inc",,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,INDUSTRY,,,,,,,2023,1.0
NCT03744910,,2018-11-06,,,2024-04-23,2018-11-13,2018-11-19,ACTUAL,,,,,,,2024-04-23,2024-04-24,ACTUAL,2019-10-14,ACTUAL,2019-10-14,2024-04,2024-04-30,2024-04-08,ACTUAL,2024-04-08,2024-04-08,ACTUAL,2024-04-08,,INTERVENTIONAL,IMAGINE,,Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients,A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients,TERMINATED,,PHASE3,194.0,ACTUAL,CSL Behring,,2.0,,Early stop for lack of efficacy/futility (at Interim analysis),f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,INDUSTRY,,,,,,,2024,0.0
NCT03471078,,2018-03-07,2021-09-10,,2023-09-19,2018-03-13,2018-03-20,ACTUAL,2021-11-22,2021-11-24,ACTUAL,,,,2023-09-19,2023-09-28,ACTUAL,2018-10-12,ACTUAL,2018-10-12,2023-09,2023-09-30,2023-01-31,ACTUAL,2023-01-31,2020-08-28,ACTUAL,2020-08-28,,INTERVENTIONAL,,,Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers,"Randomized, Double-Blind, Placebo-Controlled Study With Open-Label Extension to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Active Non-Hematological Cancers",COMPLETED,,PHASE3,122.0,ACTUAL,"Sobi, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,INDUSTRY,,,,,,,2023,1.0
NCT04471714,,2020-07-10,,,2024-09-11,2020-07-10,2020-07-15,ACTUAL,,,,,,,2024-09-11,2024-09-19,ACTUAL,2020-01-10,ACTUAL,2020-01-10,2022-02,2022-02-28,2022-03-17,ACTUAL,2022-03-17,2022-03-17,ACTUAL,2022-03-17,,INTERVENTIONAL,,,Effects of Baclofen on Presynaptic Inhibition in Humans,Effects of Baclofen on Presynaptic Inhibition in Humans,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Alberta,,2.0,,Study recruitment was halted due to restrictions and we have decided to not pursue it further.,f,,,,t,f,f,,,f,,,Upon completion of the study (TBD).,IPD will be provided to researchers who have contacted the primary investigator and requested additional data. All data will be de-identified.,,YES,De-identified individual participant data will be available to other researchers upon that researchers request.,2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,OTHER,,,,,,,2022,0.0
NCT03639311,,2018-08-10,2020-11-20,,2024-05-13,2018-08-20,2018-08-21,ACTUAL,2021-01-13,2021-01-15,ACTUAL,,,,2024-05-13,2024-06-11,ACTUAL,2018-09-24,ACTUAL,2018-09-24,2024-05,2024-05-31,2023-01-30,ACTUAL,2023-01-30,2019-12-11,ACTUAL,2019-12-11,,INTERVENTIONAL,,,"Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study","A Phase IIb, Multicenter, Open-label, Rollover Study Evaluating the Efficacy, Safety and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months in HIV-1 Infected Adults Who Are Virologically Suppressed and Participated in Study LAI116482",COMPLETED,,PHASE2,97.0,ACTUAL,ViiV Healthcare,,3.0,,,f,,,,t,t,f,,,,,,"IPD will be made available, within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.","Access is provided, after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided, for an initial period of 12 months but an extension can be granted, when justified for up to another 12 months.",http://clinicalstudydatarequest.com,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,INDUSTRY,,,,,,,2023,1.0
NCT03747939,,2018-11-19,2023-12-14,,2023-12-14,2018-11-19,2018-11-20,ACTUAL,2023-12-14,2024-01-05,ACTUAL,,,,2023-12-14,2024-01-05,ACTUAL,2018-12-31,ACTUAL,2018-12-31,2023-11,2023-11-30,2023-07-05,ACTUAL,2023-07-05,2022-12-19,ACTUAL,2022-12-19,,INTERVENTIONAL,FOREMOST,,"Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.","A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Early, Oligoarticular Psoriatic Arthritis Despite Initial Stable Treatment With Either NSAIDS and/or ≤ 1 Conventional Synthetic DMARD",COMPLETED,,PHASE4,310.0,ACTUAL,Amgen,,2.0,,,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,INDUSTRY,,,,,,,2023,1.0
NCT03112681,,2017-04-10,2024-07-16,,2024-09-03,2017-04-12,2017-04-13,ACTUAL,2024-09-03,2024-09-19,ACTUAL,,,,2024-09-03,2024-09-19,ACTUAL,2017-08-18,ACTUAL,2017-08-18,2024-09,2024-09-30,2020-08-07,ACTUAL,2020-08-07,2020-08-07,ACTUAL,2020-08-07,,INTERVENTIONAL,EPICS,,"Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis","A Phase 2, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients With Primary Biliary Cholangitis (EPICS )",COMPLETED,,PHASE2,37.0,ACTUAL,Zydus Therapeutics Inc.,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:30:49.034419,2024-10-15 03:30:49.034419,INDUSTRY,,,,,,,2020,1.0
NCT04060147,,2019-08-15,2022-08-30,,2022-08-30,2019-08-15,2019-08-16,ACTUAL,2022-08-30,2023-07-27,ACTUAL,,,,2022-08-30,2023-07-27,ACTUAL,2019-10-17,ACTUAL,2019-10-17,2022-08,2022-08-31,2021-09-02,ACTUAL,2021-09-02,2021-09-02,ACTUAL,2021-09-02,,INTERVENTIONAL,,Safety Analysis Set included all participants who took at least 1 dose of study drug.,Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis,"A Proof-of-Concept, Open-Label Study Evaluating the Safety and Tolerability of Cilofexor in Subjects With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis",TERMINATED,,PHASE1,11.0,ACTUAL,Gilead Sciences,,1.0,,The study enrollment was terminated early by the sponsor due to recruitment challenges.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,INDUSTRY,,,,,,,2021,0.0
NCT05177588,,2021-12-16,,,2023-07-17,2021-12-16,2022-01-04,ACTUAL,,,,,,,2023-07-17,2023-07-19,ACTUAL,2021-07-21,ACTUAL,2021-07-21,2023-07,2023-07-31,2023-04-30,ACTUAL,2023-04-30,2023-03-30,ACTUAL,2023-03-30,,INTERVENTIONAL,,,Efficacy of Metformin as add-on Therapy in Non-Diabetic Heart Failure Patients,Efficacy of Metformin as add-on Therapy in Non-Diabetic Heart Failure Patients,COMPLETED,,PHASE4,70.0,ACTUAL,Cairo University,,2.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,OTHER,,,,,,,2023,1.0
NCT03971825,,2019-05-31,,,2021-08-24,2019-05-31,2019-06-03,ACTUAL,,,,,,,2021-08-24,2021-08-30,ACTUAL,2018-07-24,ACTUAL,2018-07-24,2021-08,2021-08-31,2021-08-05,ACTUAL,2021-08-05,2021-08-05,ACTUAL,2021-08-05,,INTERVENTIONAL,,,A Safety Study of CC-92252 in Healthy Adult Subjects and Adult Subjects With Psoriasis,"A Phase 1, Randomized, 3-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of CC-92252 in Healthy Adult Subjects and Adult Subjects With Psoriasis.",TERMINATED,,PHASE1,131.0,ACTUAL,Celgene,,2.0,,Did not meet progression criteria,f,,,,f,t,f,,,t,,,See Plan Description,See Plan Description,https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,INDUSTRY,,,,,,,2021,0.0
NCT02435212,,2015-03-17,2024-07-09,2018-07-16,2024-09-02,2015-04-30,2015-05-06,ESTIMATED,2024-09-02,2024-09-19,ACTUAL,2018-07-20,2018-07-24,ACTUAL,2024-09-02,2024-09-19,ACTUAL,2015-10-21,ACTUAL,2015-10-21,2024-08,2024-08-31,2024-01-15,ACTUAL,2024-01-15,2018-05-31,ACTUAL,2018-05-31,,INTERVENTIONAL,,"Full Analysis Set (FAS) was defined according to the Intent to Treat (ITT) principle, and included all randomized participants.","Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload","A Randomized, Open-label, Multicenter, Two Arm, Phase II Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients With Iron Overload",COMPLETED,,PHASE2,224.0,ACTUAL,Novartis,,2.0,,,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,INDUSTRY,,,,,,,2024,1.0
NCT03597347,,2018-07-12,2021-09-13,,2022-12-14,2018-07-12,2018-07-24,ACTUAL,2021-09-13,2021-10-11,ACTUAL,,,,2022-12-14,2023-01-10,ACTUAL,2019-06-20,ACTUAL,2019-06-20,2022-12,2022-12-31,2020-10-02,ACTUAL,2020-10-02,2020-10-02,ACTUAL,2020-10-02,,INTERVENTIONAL,ENCORE,,Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection,"An Open-label, Non-controlled, Multicenter, Pilot Trial, Using Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial (NTM) Infection",TERMINATED,,PHASE2,14.0,ACTUAL,Savara Inc.,"Due to the early termination of the study, some specified endpoints had insufficient data to be analyzed:~\* Durable NTM sputum smear conversion to negative without subsequent positive smears at Week 12 after End of Treatment (EOT).~Change from Baseline to EOT and Week 12 after EOT in:~* semi-quantitative grade of number of NTM on microscopy of AFB stained sputum smears~* FEV1 (percent predicted)~* respiratory domain score assessed by CFQ-R~* body mass index",3.0,,"Recruitment for trial stopped early due to limitations from COVID-19, additionally changes in the standard of care for CF patients during the study period resulted in confounding of the primary endpoint.",,,,,t,t,t,,,,,,,,,NO,,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,INDUSTRY,,,,,,,2020,0.0
NCT03378466,,2017-11-09,,,2022-05-17,2017-12-18,2017-12-19,ACTUAL,,,,,,,2022-05-17,2022-05-24,ACTUAL,2018-03-12,ACTUAL,2018-03-12,2021-01,2021-01-31,2021-12-31,ACTUAL,2021-12-31,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,HALO,,Heparin Anticoagulation in Septic Shock,Heparin AnticoaguLation to Improve Outcomes in Septic Shock: The HALO International Phase II RCT,TERMINATED,,PHASE2,178.0,ACTUAL,University of Manitoba,,2.0,,infeasible to continue due-to inability to recruit during the COVID-19 pandemic and grants coming to an end.,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,OTHER,,,,,,,2021,0.0
NCT04350086,,2020-04-13,,,2020-08-31,2020-04-15,2020-04-16,ACTUAL,,,,,,,2020-08-31,2020-09-02,ACTUAL,2020-04-20,ESTIMATED,2020-04-20,2020-04,2020-04-30,2020-11-20,ESTIMATED,2020-11-20,2020-11-20,ESTIMATED,2020-11-20,,INTERVENTIONAL,PRODEX,,Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection,Prospective Study of the Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection,WITHDRAWN,,PHASE4,0.0,ACTUAL,"University Hospital, Limoges",,1.0,,unfavorable opinion of the ethics committee,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,OTHER,,,,,,,2020,0.0
NCT03657160,,2018-08-30,2023-02-07,,2023-05-09,2018-08-30,2018-09-04,ACTUAL,2023-03-22,2023-04-14,ACTUAL,,,,2023-05-09,2023-06-06,ACTUAL,2019-02-06,ACTUAL,2019-02-06,2023-05,2023-05-31,2022-05-09,ACTUAL,2022-05-09,2022-02-07,ACTUAL,2022-02-07,,INTERVENTIONAL,,"Full Analysis Set (FAS) included all participants who were randomized, received at least 1 dose of the treatment, and under-went allo-HSCT.",Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation,"A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus-Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation",COMPLETED,,PHASE3,343.0,ACTUAL,Takeda,,2.0,,,f,,,,t,t,f,,,t,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,INDUSTRY,,,,,,,2022,1.0
NCT02129348,,2014-04-29,2021-03-18,,2024-04-29,2014-05-01,2014-05-02,ESTIMATED,2021-07-21,2021-08-16,ACTUAL,,,,2024-04-29,2024-05-02,ACTUAL,2014-06,,2014-06-30,2024-04,2024-04-30,2020-01,ACTUAL,2020-01-31,2020-01,ACTUAL,2020-01-31,,INTERVENTIONAL,,,Treatment of Psychosis and Agitation in Alzheimer's Disease,Treatment of Psychosis and Agitation in Alzheimer's Disease,COMPLETED,,PHASE2,77.0,ACTUAL,New York State Psychiatric Institute,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,OTHER,,,,,,,2020,1.0
NCT03205553,,2017-06-28,2021-11-01,,2021-11-01,2017-06-28,2017-07-02,ACTUAL,2021-11-01,2021-12-20,ACTUAL,,,,2021-11-01,2021-12-20,ACTUAL,2018-02-01,ACTUAL,2018-02-01,2021-11,2021-11-30,2020-10-21,ACTUAL,2020-10-21,2018-05-02,ACTUAL,2018-05-02,,INTERVENTIONAL,,,Direct Peritoneal Resuscitation in Gastroschisis,Direct Peritoneal Resuscitation in Gastroschisis,TERMINATED,,PHASE1,3.0,ACTUAL,University of Arkansas,,2.0,,COVID-19 pandemic,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,OTHER,,,,,,,2020,0.0
NCT05312697,,2022-03-28,,2023-06-27,2023-06-27,2022-03-28,2022-04-05,ACTUAL,,,,,2023-06-29,ACTUAL,2023-06-27,2023-06-29,ACTUAL,2022-04-28,ACTUAL,2022-04-28,2023-06,2023-06-30,2022-07-07,ACTUAL,2022-07-07,2022-07-07,ACTUAL,2022-07-07,,INTERVENTIONAL,,,"Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta","A Phase 2b, Multicenter, Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta",TERMINATED,,PHASE2,2.0,ACTUAL,Ultragenyx Pharmaceutical Inc,,2.0,,Sponsor decision not related to safety concerns,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,INDUSTRY,,,,,,,2022,0.0
NCT03629249,,2018-08-09,2021-01-13,2020-06-11,2021-10-07,2018-08-09,2018-08-14,ACTUAL,2021-01-13,2021-02-02,ACTUAL,2020-06-11,2020-06-12,ACTUAL,2021-10-07,2021-10-11,ACTUAL,2018-12-13,ACTUAL,2018-12-13,2021-10,2021-10-31,2020-02-06,ACTUAL,2020-02-06,2020-02-06,ACTUAL,2020-02-06,,INTERVENTIONAL,,,Systemic Corticosteroids Avoidance Study in Severe Asthma Patients,"A 52-week, Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Placebo-controlled Study of Fevipiprant Once Daily Plus Standard-of-care (SoC) for Reduction of Systemic Corticosteroids (Oral and Parenteral) Use in Patients With Severe Asthma",TERMINATED,,PHASE3,604.0,ACTUAL,Novartis,,3.0,,Company decision,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.",2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,INDUSTRY,,,,,,,2020,0.0
NCT03561883,,2018-06-07,2021-07-23,,2021-07-23,2018-06-18,2018-06-19,ACTUAL,2021-07-23,2021-08-18,ACTUAL,,,,2021-07-23,2021-08-18,ACTUAL,2018-09-06,ACTUAL,2018-09-06,2021-07,2021-07-31,2020-11-06,ACTUAL,2020-11-06,2020-07-28,ACTUAL,2020-07-28,,INTERVENTIONAL,,Safety Population: Participants who received at least 1 dose of study drug.,Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs),"A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients With Gastroesophageal Reflux Disease While Receiving Proton Pump Inhibitors",COMPLETED,,PHASE3,609.0,ACTUAL,"Ironwood Pharmaceuticals, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,INDUSTRY,,,,,,,2020,1.0
NCT05953545,,2023-07-19,,,2024-05-22,2023-07-19,2023-07-20,ACTUAL,,,,,,,2024-05-22,2024-05-23,ACTUAL,2024-05-22,ACTUAL,2024-05-22,2024-05,2024-05-31,2024-05-22,ACTUAL,2024-05-22,2024-05-22,ACTUAL,2024-05-22,,INTERVENTIONAL,,,Peginterferon Lambda and Lonafarnib Boosted With Ritonavir 48-Week Combination Therapy for Delta Hepatitis,Open Label Phase 2 Clinical Study of Peginterferon Lambda and Lonafarnib Boosted With Ritonavir 48-Week Combination Therapy for Delta Hepatitis,WITHDRAWN,,PHASE2,0.0,ACTUAL,National Institutes of Health Clinical Center (CC),,1.0,,Study closure based on decision of the PI,f,,,,,t,f,,,,,,,,,UNDECIDED,,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,NIH,,,,,,,2024,0.0
NCT03603314,,2018-07-05,2022-12-22,,2023-01-31,2018-07-26,2018-07-27,ACTUAL,2023-01-31,2023-03-01,ACTUAL,,,,2023-01-31,2023-03-01,ACTUAL,2019-02-15,ACTUAL,2019-02-15,2022-12,2022-12-31,2022-01-12,ACTUAL,2022-01-12,2021-11-04,ACTUAL,2021-11-04,,INTERVENTIONAL,AUDIBLE-S,,Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss,"A Two-part, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of SENS-401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss",COMPLETED,,PHASE2/PHASE3,115.0,ACTUAL,Sensorion,,3.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,INDUSTRY,,,,,,,2022,1.0
NCT03265977,,2017-08-24,,,2018-04-06,2017-08-28,2017-08-29,ACTUAL,,,,,,,2018-04-06,2018-04-10,ACTUAL,2018-06,ESTIMATED,2018-06-30,2018-04,2018-04-30,2021-06-30,ESTIMATED,2021-06-30,2021-04-30,ESTIMATED,2021-04-30,,INTERVENTIONAL,A-043,,A Phase II Study of H56:IC31 in Healthy Adolescents,"A Randomized, Placebo Controlled, Double-Blind Phase II Study to Evaluate Safety, Immunogenicity, and Prevention of Infection With Mycobacterium Tuberculosis (Mtb) of H56:IC31 in Healthy Adolescents",WITHDRAWN,,PHASE2,0.0,ACTUAL,Aeras,,2.0,,"Design, sponsorship changed prior to initiation. No study procedures done.",f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,OTHER,,,,,,,2021,0.0
NCT02707978,,2015-04-07,,,2024-03-11,2016-03-08,2016-03-14,ESTIMATED,,,,,,,2024-03-11,2024-03-13,ACTUAL,2017-09-30,ESTIMATED,2017-09-30,2024-03,2024-03-31,2020-12-30,ACTUAL,2020-12-30,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,,,F 18 T807 Tau PET Imaging of Frontotemporal Dementia (FTD),F 18 T807 Tau PET Imaging of Frontotemporal Dementia,WITHDRAWN,,PHASE2,0.0,ACTUAL,Washington University School of Medicine,,1.0,,Problems with contracts .,f,,,,f,t,f,,,,,,,,,,,2024-10-16 14:53:55.066686,2024-10-16 14:53:55.066686,OTHER,,,,,,,2020,0.0
NCT02549092,,2015-09-11,2021-05-07,,2023-11-06,2015-09-11,2015-09-15,ESTIMATED,2021-05-07,2021-06-03,ACTUAL,,,,2023-11-06,2023-11-28,ACTUAL,2015-10-26,ACTUAL,2015-10-26,2023-11,2023-11-30,2022-11-18,ACTUAL,2022-11-18,2020-05-14,ACTUAL,2020-05-14,,INTERVENTIONAL,,"Safety dataset: all participants randomized to OMT, and all participants randomized to LCIG who had study device (NJ and/or PEG-J) placement.",A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD),"An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) THerapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects With Advanced Parkinson's Disease - INSIGHTS Study",COMPLETED,,PHASE3,89.0,ACTUAL,AbbVie,,2.0,,,f,,,,f,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,INDUSTRY,,,,,,,2022,1.0
NCT03889756,,2019-03-22,2023-01-25,,2023-03-31,2019-03-22,2019-03-26,ACTUAL,2023-03-31,2023-04-24,ACTUAL,,,,2023-03-31,2023-04-24,ACTUAL,2019-07-17,ACTUAL,2019-07-17,2023-03,2023-03-31,2023-01-05,ACTUAL,2023-01-05,2019-12-18,ACTUAL,2019-12-18,,INTERVENTIONAL,SAD-KIDS,Demographic data will be presented together to avoid unblinding of subjects due to small number of participants,Ketamine for Severe Adolescent Depression: Intermediate-term Safety and Efficacy,Ketamine for Severe Adolescent Depression: Intermediate-term Safety and Efficacy,TERMINATED,,PHASE2/PHASE3,3.0,ACTUAL,Yale University,"The study was only able to enroll 3 participants before the pandemic started and then ran out of funding to finish the trial. Presented are summary data and to avoid revealing any identifying information of participants, data is presented overall where applicable (e.g. baseline characteristics).",2.0,,No more funding available to continue since we could not recruit throughout the pandemic.,f,,,,,t,f,,,,,,,,,,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,OTHER,,,,,,,2023,0.0
NCT05076253,,2021-10-08,,,2021-12-14,2021-10-12,2021-10-13,ACTUAL,,,,,,,2021-12-14,2021-12-15,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2021-12,2021-12-31,2021-12-01,ACTUAL,2021-12-01,2021-12-01,ACTUAL,2021-12-01,,INTERVENTIONAL,,,Efficacy of Ivermectin in COVID-19,"Efficacy and Safety of Ivermectin in Treatment of Mild to Moderate COVID-19 Infection: a Randomized ,Double Blind,Placebo,Controlled Trial",COMPLETED,,PHASE1/PHASE2,72.0,ACTUAL,Bangkok Metropolitan Administration Medical College and Vajira Hospital,,2.0,,,f,,,,t,f,f,,,,,,After publication,,,YES,Data will be made available upon request after publication,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,OTHER_GOV,,,,,,,2021,0.0
NCT02343549,,2015-01-16,2021-07-17,,2022-11-01,2015-01-16,2015-01-22,ESTIMATED,2021-07-17,2021-08-10,ACTUAL,,,,2022-11-01,2022-11-03,ACTUAL,2015-01,,2015-01-31,2021-09,2021-09-30,2020-07-11,ACTUAL,2020-07-11,2020-07-11,ACTUAL,2020-07-11,,INTERVENTIONAL,,,A Phase II Study of Optune (NovoTTF) in Combination With Bevacizumab (BEV) and Temozolomide (TMZ) in Patients With Newly Diagnosed Unresectable Glioblastoma (GBM),A Phase II Study of Optune (NovoTTF) in Combination With Bevacizumab (BEV) and Temozolomide (TMZ) in Patients With Newly Diagnosed Unresectable Glioblastoma (GBM),TERMINATED,,PHASE2,13.0,ACTUAL,Wake Forest University Health Sciences,,1.0,,closed to accrual due to low accrual,f,,,,t,,,,,,,,,,,,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,OTHER,,,,,,,2020,0.0
NCT04166552,,2019-11-06,,,2023-09-16,2019-11-14,2019-11-18,ACTUAL,,,,,,,2023-09-16,2023-09-21,ACTUAL,2020-06-11,ACTUAL,2020-06-11,2022-09,2022-09-30,2024-10,ESTIMATED,2024-10-31,2024-07,ESTIMATED,2024-07-31,,INTERVENTIONAL,,,"Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic Sclerosis","A Phase IIa, Double-Blind, Randomised, Intracohort Placebo-Controlled, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 in Patients With Diffuse Cutaneous Systemic Sclerosis",SUSPENDED,,PHASE2,36.0,ESTIMATED,Emerald Health Pharmaceuticals,,4.0,,Sponsor ceasing all operations due to company's shut down,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,INDUSTRY,,,,,,,2024,0.0
NCT05119439,,2021-11-05,,,2023-07-23,2021-11-05,2021-11-15,ACTUAL,,,,,,,2023-07-23,2023-07-25,ACTUAL,2022-10-07,ACTUAL,2022-10-07,2023-07,2023-07-31,2023-06-30,ACTUAL,2023-06-30,2023-06-30,ACTUAL,2023-06-30,,INTERVENTIONAL,,,Mifepristone and Two Doses of Misoprostol for Abortion at 11&12 Weeks,An Outpatient Medical Abortion Regimen With Mifepristone and Two Doses of Misoprostol at 71-77 and 78-84 Days of Pregnancy,TERMINATED,,PHASE4,23.0,ACTUAL,Gynuity Health Projects,,2.0,,Enrollment,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,OTHER,,,,,,,2023,0.0
NCT04460105,,2020-06-30,,,2020-10-09,2020-07-06,2020-07-07,ACTUAL,,,,,,,2020-10-09,2020-10-12,ACTUAL,2020-10-31,ESTIMATED,2020-10-31,2020-10,2020-10-31,2021-01-27,ESTIMATED,2021-01-27,2021-01-27,ESTIMATED,2021-01-27,,INTERVENTIONAL,,,Lanadelumab in Participants Hospitalized With COVID-19 Pneumonia,"A Phase 1b, Randomized, Double-blind, Single and Repeat Dosing Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab When Added to Standard-of-Care in Subjects Hospitalized With COVID-19 Pneumonia",WITHDRAWN,,PHASE1,0.0,ACTUAL,Takeda,,2.0,,Study was withdrawn due to challenges in site recruitment and lack of patient enrollment,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,INDUSTRY,,,,,,,2021,0.0
NCT03661528,,2018-08-30,2024-05-24,,2024-07-01,2018-09-06,2018-09-07,ACTUAL,2024-07-01,2024-07-03,ACTUAL,,,,2024-07-01,2024-07-03,ACTUAL,2019-06-06,ACTUAL,2019-06-06,2024-07,2024-07-31,2023-08-09,ACTUAL,2023-08-09,2023-05-27,ACTUAL,2023-05-27,,INTERVENTIONAL,,"Measured in the Intent-to-Treat Population (ITT), Extended Population, which included all randomized participants according to the randomized treatment.",Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor,A Randomized Clinical Trial of Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor,COMPLETED,,PHASE4,530.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,INDUSTRY,,,,,,,2023,1.0
NCT03613259,,2018-01-23,,,2020-06-04,2018-07-27,2018-08-03,ACTUAL,,,,,,,2020-06-04,2020-06-09,ACTUAL,2020-06-01,ESTIMATED,2020-06-01,2020-06,2020-06-30,2022-06-01,ESTIMATED,2022-06-01,2022-06-01,ESTIMATED,2022-06-01,,INTERVENTIONAL,,,Fluorothymidine F-18 PET in Diagnosing Patients With Intermediate or High Grade Soft Tissue Sarcoma,A Pilot Study Investigating ¹⁸F-FLT-PET as a Marker of Response to Preoperative Radiotherapy in Soft Tissue Sarcoma,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,OHSU Knight Cancer Institute,,1.0,,Funding expired,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,OTHER,,,,,,,2022,0.0
NCT03004105,,2016-12-20,,,2018-03-14,2016-12-22,2016-12-28,ESTIMATED,,,,,,,2018-03-14,2018-03-16,ACTUAL,2018-05,ESTIMATED,2018-05-31,2018-03,2018-03-31,2024-05,ESTIMATED,2024-05-31,2023-05,ESTIMATED,2023-05-31,,INTERVENTIONAL,,,MEDI4736 With Selumetinib for KRAS Mutant Non-Small Cell Lung Cancer (NSCLC),Phase II Trial of Immunotherapy With Durvalumab (MEDI4736) With Continuous or Intermittent MEK Inhibitor Selumetinib in KRAS Mutant Non-Small Cell Lung Cancer (NSCLC),WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,3.0,,Inadequate funding,f,,,,f,t,f,,,,,,,,,,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,OTHER,,,,,,,2024,0.0
NCT03733925,,2018-11-05,2022-11-09,,2022-12-27,2018-11-05,2018-11-07,ACTUAL,2022-12-27,2023-01-20,ACTUAL,,,,2022-12-27,2023-01-20,ACTUAL,2019-01-07,ACTUAL,2019-01-07,2022-12,2022-12-31,2021-11-15,ACTUAL,2021-11-15,2021-11-15,ACTUAL,2021-11-15,,INTERVENTIONAL,,,A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis,"A Phase-IV, Multicenter, Noncomparative, Open-Label Study Evaluating the Safety and Efficacy of Golimumab (a Fully Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously) in the Treatment of Indian Patients With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis",COMPLETED,,PHASE4,100.0,ACTUAL,Johnson & Johnson Private Limited,,1.0,,,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,INDUSTRY,,,,,,,2021,1.0
NCT05703308,,2023-01-15,,,2023-01-26,2023-01-26,2023-01-30,ACTUAL,,,,,,,2023-01-26,2023-01-30,ACTUAL,2020-06-21,ACTUAL,2020-06-21,2023-01,2023-01-31,2022-10-22,ACTUAL,2022-10-22,2021-09-22,ACTUAL,2021-09-22,,INTERVENTIONAL,,,Menstrual Blood Stem Cells in Poor Ovarian Responders,Outcome of Pregnancy in Poor Ovarian Responders by Intraovarian Administration of Autologous Menstrual Blood Derived-Mesenchymal Stromal Cells,COMPLETED,,PHASE3,180.0,ACTUAL,Avicenna Research Institute,,2.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,OTHER,,,,,,,2022,1.0
NCT00924326,,2009-06-17,2019-01-04,,2021-12-29,2009-06-17,2009-06-18,ESTIMATED,2019-03-20,2019-03-21,ACTUAL,,,,2021-12-29,2022-01-12,ACTUAL,2009-02-17,ACTUAL,2009-02-17,2021-12,2021-12-31,2021-11-17,ACTUAL,2021-11-17,2015-09-30,ACTUAL,2015-09-30,,INTERVENTIONAL,,,CAR T Cell Receptor Immunotherapy for Patients With B-cell Lymphoma,An Assessment of the Safety and Feasibility of Administering T-Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With B-Cell Lymphoma,COMPLETED,,PHASE1/PHASE2,43.0,ACTUAL,National Institutes of Health Clinical Center (CC),,10.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,NIH,,,,,,,2021,1.0
NCT02770820,,2016-03-25,2021-05-28,,2021-10-15,2016-05-10,2016-05-12,ESTIMATED,2021-05-28,2021-06-23,ACTUAL,,,,2021-10-15,2021-10-29,ACTUAL,2017-11-06,ACTUAL,2017-11-06,2021-08,2021-08-31,2020-06-01,ACTUAL,2020-06-01,2020-06-01,ACTUAL,2020-06-01,,INTERVENTIONAL,,,Laboratory-Treated (Central Memory/Naive) CD8+ T Cells in Treating Patients With Newly Diagnosed or Relapsed Acute Myeloid Leukemia,Phase I/II Study of Autologous (Central Memory/Naïve) CD8+ T Cells That Have Been Transduced to Express a WT1-Specific T Cell Receptor for Treatment of AML,TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,Terminated due to funding difficulties,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,OTHER,,,,,,,2020,0.0
NCT03900624,,2019-04-01,2022-08-04,,2024-02-19,2019-04-01,2019-04-03,ACTUAL,2022-08-04,2022-08-26,ACTUAL,,,,2024-02-19,2024-02-23,ACTUAL,2019-04-21,ACTUAL,2019-04-21,2024-02,2024-02-29,2022-05-15,ACTUAL,2022-05-15,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,iSTAT PICU,,Ideal Steroids for Asthma Treatment in the PICU,"Ideal Steroids for Asthma Treatment in the PICU (iSTAT PICU): A Prospective, Comparative, Single-arm Study Assessing Dexamethasone Versus Methylprednisolone in Severe Status Asthmaticus Admitted to the Pediatric Intensive Care Unit",COMPLETED,,PHASE4,92.0,ACTUAL,Johns Hopkins All Children's Hospital,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,OTHER,,,,,,,2022,1.0
NCT03744715,,2018-11-08,,2024-03-01,2024-03-01,2018-11-14,2018-11-16,ACTUAL,,,,,2024-03-05,ACTUAL,2024-03-01,2024-03-05,ACTUAL,2018-10-05,ACTUAL,2018-10-05,2024-03,2024-03-31,2023-03-03,ACTUAL,2023-03-03,2023-03-03,ACTUAL,2023-03-03,,INTERVENTIONAL,,,A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib,An Open-Label Extension Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib,TERMINATED,,PHASE2,7.0,ACTUAL,"Spectrum Pharmaceuticals, Inc",,1.0,,"Business reasons, not related to safety.",f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,INDUSTRY,,,,,,,2023,0.0
NCT02648347,,2016-01-04,2022-04-25,2021-06-03,2022-06-07,2016-01-06,2016-01-07,ESTIMATED,2022-06-07,2022-06-27,ACTUAL,2021-06-03,2021-06-11,ACTUAL,2022-06-07,2022-06-27,ACTUAL,2015-12,ACTUAL,2015-12-31,2022-06,2022-06-30,2020-07-31,ACTUAL,2020-07-31,2020-06-04,ACTUAL,2020-06-04,,INTERVENTIONAL,,,Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease,"Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects With Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CORRECTION)",COMPLETED,,PHASE3,1751.0,ACTUAL,Akebia Therapeutics,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,INDUSTRY,,,,,,,2020,1.0
NCT03287050,,2017-09-15,2021-09-21,2020-12-29,2021-12-13,2017-09-15,2017-09-19,ACTUAL,2021-12-13,2021-12-15,ACTUAL,2021-12-13,2021-12-15,ACTUAL,2021-12-13,2021-12-15,ACTUAL,2018-01-24,ACTUAL,2018-01-24,2021-12,2021-12-31,2020-11-10,ACTUAL,2020-11-10,2019-03-13,ACTUAL,2019-03-13,,INTERVENTIONAL,,,"Anti-PD(L)1 and SBRT in the Treatment of Advanced, Platinum-Refractory Urothelial Carcinoma","FAST: Feasibility Trial of Anti-PD(L)1 and SBRT in the Treatment of Advanced, Platinum-Refractory Urothelial Carcinoma",TERMINATED,,PHASE2,6.0,ACTUAL,University of Michigan Rogel Cancer Center,This study was closed early (at 6 patients) due to changing therapeutic landscape in metastatic bladder cancer and lack of radiation/immunotherapy systemic synergy in other malignancies.,1.0,,due to changing therapeutic landscape in metastatic bladder cancer and lack of radiation/immunotherapy systemic synergy in other malignancies,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,OTHER,,,,,,,2020,0.0
NCT03025880,,2017-01-11,2022-02-03,,2023-03-03,2017-01-19,2017-01-20,ESTIMATED,2022-04-12,2023-01-10,ACTUAL,,,,2023-03-03,2023-04-03,ACTUAL,2017-06-28,ACTUAL,2017-06-28,2023-03,2023-03-31,2021-07-22,ACTUAL,2021-07-22,2019-06-03,ACTUAL,2019-06-03,,INTERVENTIONAL,PANGEA,,Trial to Evaluate Efficacy and Safety of Pembrolizumab and Gemcitabine in HER2-negative ABC,A Multicenter Phase II Trial to Evaluate the Efficacy and Safety of Pembrolizumab and Gemcitabine in Patients With HER2-negative Advanced Breast Cancer (ABC) PANGEA-Breast,COMPLETED,,PHASE2,36.0,ACTUAL,Spanish Breast Cancer Research Group,,1.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,OTHER,,,,,,,2021,0.0
NCT04582318,,2020-10-07,,,2022-02-08,2020-10-08,2020-10-09,ACTUAL,,,,,,,2022-02-08,2022-02-25,ACTUAL,2020-11-09,ACTUAL,2020-11-09,2022-02,2022-02-28,2021-03-11,ACTUAL,2021-03-11,2021-02-18,ACTUAL,2021-02-18,,INTERVENTIONAL,,,"A Phase 1/2 Study to Assess the Safety, Tolerability and Pharmacokinetics of NGM621 in Healthy Subjects, and to Assess the Safety, PK and Efficacy in Subjects With Moderate to Severe ARDS Caused by COVID-19","A Randomized, Double Blind, Placebo Controlled, Combined Phase 1/2 Single Dose and Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of NGM621 in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Subjects With Confirmed SARS-CoV-2 Infection",TERMINATED,,PHASE1/PHASE2,16.0,ACTUAL,"NGM Biopharmaceuticals, Inc",,8.0,,"Due to the rapidly changing therapeutic landscape in the COVID-19 space and an assessment of unmet medical need, Part 2 of the study was cancelled (per protocol Section 4.3). Meanwhile, Part 1 of the study was completed.",f,,,,t,f,f,,,,,,,,,UNDECIDED,"This is a proof-of-concept study assessing the safety, tolerability, PK, and efficacy of systemic use of NGM621 versus placebo in both healthy subjects and subjects confirmed with SARS-CoV-2 infection. We will continue to evaluate whether IPD will be shared with other researchers.",2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,INDUSTRY,,,,,,,2021,0.0
NCT02555111,,2015-08-28,,,2022-07-22,2015-09-17,2015-09-21,ESTIMATED,,,,,,,2022-07-22,2022-07-26,ACTUAL,2015-09,ACTUAL,2015-09-30,2020-03,2020-03-31,2020-02,ACTUAL,2020-02-29,2020-02,ACTUAL,2020-02-29,,INTERVENTIONAL,RIPORT,,Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis.,Multicentric Randomized Study of Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis.,COMPLETED,,PHASE3,112.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,,f,,,,t,,,,,,,,,,,UNDECIDED,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,OTHER,,,,,,,2020,1.0
NCT03389438,,2017-12-27,,,2021-11-19,2017-12-27,2018-01-03,ACTUAL,,,,,,,2021-11-19,2021-12-01,ACTUAL,2018-02-26,ACTUAL,2018-02-26,2017-12,2017-12-31,2021-10-31,ACTUAL,2021-10-31,2021-02-26,ACTUAL,2021-02-26,,INTERVENTIONAL,,,Autologous Cellular Immunotherapy in Patients With Metastatic Bladder Urothelial Carcinoma,A Single-center Randomized Controlled Trial of Autologous Cellular Immunotherapy in Patients With Metastatic Bladder Urothelial Carcinoma Treated With First-line Gemcitabine Plus Cisplatin,TERMINATED,,PHASE2,6.0,ACTUAL,Beijing Huanxing Cancer Hospital,,2.0,,Shortage of funds.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,OTHER,,,,,,,2021,0.0
NCT01938547,,2013-08-30,,,2024-05-14,2013-09-04,2013-09-10,ESTIMATED,,,,,,,2024-05-14,2024-05-16,ACTUAL,2014-03,ACTUAL,2014-03-31,2024-05,2024-05-31,2024-02-20,ACTUAL,2024-02-20,2024-02-20,ACTUAL,2024-02-20,,INTERVENTIONAL,PIONEER,,"Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER)","Open Label Study to Assess the Efficacy, Safety and Dosing of Clevidipine in Pediatric Patients Undergoing Surgery",TERMINATED,,PHASE4,22.0,ACTUAL,Chiesi Farmaceutici S.p.A.,,1.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,INDUSTRY,,,,,,,2024,0.0
NCT03920657,,2018-12-14,,,2022-11-16,2019-04-18,2019-04-19,ACTUAL,,,,,,,2022-11-16,2022-11-21,ACTUAL,2019-10-04,ACTUAL,2019-10-04,2021-03,2021-03-31,2022-04-22,ACTUAL,2022-04-22,2020-10-06,ACTUAL,2020-10-06,,INTERVENTIONAL,,,Early and Low Dose Deferasirox (3.5 mg/kg FCT) to Suppress NTBI and LPI as Early Intervention to Prevent Tissue Iron Overload in Lower Risk MDS,Early and Low Dose Deferasirox (3.5 mg/kg FCT) to Suppress NTBI and LPI as Early Intervention to Prevent Tissue Iron Overload in Lower Risk MDS,TERMINATED,,PHASE2,11.0,ACTUAL,Fondazione Italiana Sindromi Mielodisplastiche-ETS,,1.0,,enrollment failed,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,OTHER,,,,,,,2022,0.0
NCT04285749,,2020-02-24,,,2020-07-23,2020-02-25,2020-02-26,ACTUAL,,,,,,,2020-07-23,2020-07-27,ACTUAL,2020-11-06,ESTIMATED,2020-11-06,2020-07,2020-07-31,2021-04-01,ESTIMATED,2021-04-01,2021-04-01,ESTIMATED,2021-04-01,,INTERVENTIONAL,,,Prevention of Recurrence and Metastasis in Genetically High-Risk Melanomas,Prevention of Recurrence and Metastasis in Genetically High-Risk Melanomas,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Case Comprehensive Cancer Center,,1.0,,PI moving to new institution prior to study activation,f,,,,f,t,f,,,t,,,,,,NO,"This study is a pilot study to help assess the power needed for a larger study and to determine biologic activity. If a larger study is conducted, data will be shared.",2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,OTHER,,,,,,,2021,0.0
NCT05306873,,2022-03-11,,,2024-09-16,2022-03-23,2022-04-01,ACTUAL,,,,,,,2024-09-16,2024-09-19,ACTUAL,2022-10-28,ACTUAL,2022-10-28,2024-09,2024-09-30,2024-04-20,ACTUAL,2024-04-20,2024-04-20,ACTUAL,2024-04-20,,INTERVENTIONAL,DIVERT,,Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus,"A Phase 2, Double-Blind, Placebo-Controlled Trial of Mycophenolate Mofetil Alone or With Voclosporin for Systemic Lupus: Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment (DIVERT) (ALE10)",TERMINATED,,PHASE2,9.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,4.0,,The study was closed due to slow enrollment.,f,,,,t,t,f,,,,,,"On average, within 24 months after database lock for the trial.",Open access.,https://www.immport.org/home,YES,"The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.",2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,NIH,,,,,,,2024,0.0
NCT03496623,,2018-03-29,2023-10-09,,2023-11-21,2018-04-05,2018-04-12,ACTUAL,2023-11-21,2023-11-24,ACTUAL,,,,2023-11-21,2023-11-24,ACTUAL,2018-05-08,ACTUAL,2018-05-08,2023-11,2023-11-30,2022-10-13,ACTUAL,2022-10-13,2022-10-13,ACTUAL,2022-10-13,,INTERVENTIONAL,PERFECT,Full Analysis Set included all participants who were randomized and received at least one dose of study drug.,A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD),"A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)",TERMINATED,,PHASE3,188.0,ACTUAL,United Therapeutics,"Per sponsor decision, the study was terminated early. Data were not collected for the secondary outcome measures due to study termination and lack of appropriate sample size.",2.0,,Sponsor's decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,INDUSTRY,,,,,,,2022,0.0
NCT03257722,,2017-08-16,2023-08-03,,2024-01-30,2017-08-21,2017-08-22,ACTUAL,2024-01-30,2024-02-28,ACTUAL,,,,2024-01-30,2024-02-28,ACTUAL,2017-09-26,ACTUAL,2017-09-26,2024-01,2024-01-31,2021-08-25,ACTUAL,2021-08-25,2020-08-15,ACTUAL,2020-08-15,,INTERVENTIONAL,PIL,No patients were enrolled in Phase 2.,Pembrolizumab + Idelalisib for Lung Cancer Study,A Phase Ib /II Trial of Pembrolizumab and Idelalisib in Patients With Non-small Cell Lung Cancer (NSCLC) Who Have Failed Immune Checkpoint Inhibitor,TERMINATED,,PHASE1/PHASE2,4.0,ACTUAL,Augusta University,,2.0,,The study was terminated due to poor accrual.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,OTHER,,,,,,,2021,0.0
NCT02597660,,2015-11-03,,,2022-03-29,2015-11-04,2015-11-05,ESTIMATED,,,,,,,2022-03-29,2022-03-31,ACTUAL,2020-05-01,ACTUAL,2020-05-01,2020-11,2020-11-30,2020-12-01,ACTUAL,2020-12-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,,,A Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy,A Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy,WITHDRAWN,,PHASE2,0.0,ACTUAL,"Hospital for Special Surgery, New York",,2.0,,PI decided not to enroll,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,OTHER,,,,,,,2020,0.0
NCT05242432,,2022-02-15,,,2024-04-25,2022-02-15,2022-02-16,ACTUAL,,,,,,,2024-04-25,2024-04-26,ACTUAL,2022-04-01,ACTUAL,2022-04-01,2024-04,2024-04-30,2023-03-20,ACTUAL,2023-03-20,2023-03-20,ACTUAL,2023-03-20,,INTERVENTIONAL,,,A Study of Adenovirus Serotype 26.Respiratory Syncytial Virus.Pre-Fusion F (Ad26.RSV.preF)-Based Vaccine for Prevention of Respiratory Syncytial Virus (RSV) Mediated- Lower Respiratory Tract Disease (LRTD) in Japanese Participants,"A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Efficacy, Safety, Reactogenicity, and Immunogenicity of an Ad26.RSV.preF-based Vaccine in Japanese Adults Aged 60 Years and Older, and Safety, Reactogenicity, and Immunogenicity of the Vaccine in Japanese Adults Aged 20 to 59 Years at High-risk of RSV Disease",TERMINATED,,PHASE3,2192.0,ACTUAL,Janssen Pharmaceutical K.K.,,4.0,,Terminated (Janssen made the strategic decision to discontinue the RSV3007 study. This decision is not based on any safety concerns.),f,,,,t,f,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 15:00:15.640833,2024-10-16 15:00:15.640833,INDUSTRY,,,,,,,2023,0.0
NCT02587962,,2015-10-21,2020-09-24,,2020-12-21,2015-10-23,2015-10-27,ESTIMATED,2020-12-21,2021-01-14,ACTUAL,,,,2020-12-21,2021-01-14,ACTUAL,2017-08-04,ACTUAL,2017-08-04,2020-12,2020-12-31,2020-02-17,ACTUAL,2020-02-17,2020-02-17,ACTUAL,2020-02-17,,INTERVENTIONAL,,,Dose-escalation Study of Birinapant and Pembrolizumab in Solid Tumors,"A Phase 1/2 Multicenter, Single-Arm, Open-Label, Dose-Escalation Study of Birinapant in Combination With Pembrolizumab (KEYTRUDA®) in Patients With Relapsed or Refractory Solid Tumors",TERMINATED,,PHASE1/PHASE2,34.0,ACTUAL,Medivir,"The dose escalation (Phase 1) part was analyzed per the protocol. Based on data from the interim analysis of the colorectal cancer cohort (dose expansion \[Phase 2\] part), the study was closed early due to futility on recommendation by the data monitoring committee (DMC).",1.0,,"Based on a futility analysis, the data monitoring committee recommended to stop enrollment.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,INDUSTRY,,,,,,,2020,0.0
NCT03552692,,2018-05-10,,,2023-12-11,2018-06-08,2018-06-12,ACTUAL,,,,,,,2023-12-11,2023-12-12,ACTUAL,2018-09-25,ACTUAL,2018-09-25,2023-12,2023-12-31,2023-02-17,ACTUAL,2023-02-17,2020-03-04,ACTUAL,2020-03-04,,INTERVENTIONAL,,,Use of Venetoclax as Single Agent in Patients With Relapsed/Refractory BCL-2 Positive Peripheral T Cell Lymphoma,"A Phase II, Open Label, Multicenter Trial of Venetoclax (ABT-199/GDC-0199) as Single Agent in Patients With Relapsed/Refractory BCL-2 Positive Peripheral T Cell Lymphoma Not Otherwise Specified (PTCL-NOS), Angioimmunoblastic T-cell Lymphoma (AITL) and Other Nodal T-cell Lymphomas of T-follicular Helper Origin (TFH)",TERMINATED,,PHASE2,22.0,ACTUAL,Fondazione Italiana Linfomi - ETS,,1.0,,efficacy lower than expected,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,OTHER,,,,,,,2023,0.0
NCT04476329,,2020-07-14,,,2021-12-10,2020-07-16,2020-07-20,ACTUAL,,,,,,,2021-12-10,2021-12-30,ACTUAL,2021-01-21,ACTUAL,2021-01-21,2021-12,2021-12-31,2021-12-10,ACTUAL,2021-12-10,2021-10-13,ACTUAL,2021-10-13,,INTERVENTIONAL,ReDos HCC,,Optimization for Regorafenib in HCC,A Randomized Phase II Study of First Cycle Optimization for Regorafenib Treatment Compared to Standard Dose of Regorafenib in Patients With HCC Who Failed Any 1st Line Systemic Treatment and for Whom the Physician is Intending to Treat With Regorafenib,TERMINATED,,PHASE2,7.0,ACTUAL,"SC Liver Research Consortium, LLC",,2.0,,"Enrollment rate not sufficient to meet funding entity's corporation timeline expectations, entity terminated study's fiscal support. Termination decision was purely administrative in nature and did not involve drug or patient safety issues.",f,,,,t,t,f,,,f,,,,,,NO,"Only aggregated data will be available for review, analysis and reporting.",2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,OTHER,,,,,,,2021,0.0
NCT05099822,,2021-09-09,,,2023-12-08,2021-10-19,2021-10-29,ACTUAL,,,,,,,2023-12-08,2023-12-14,ACTUAL,2020-03-13,ACTUAL,2020-03-13,2023-12,2023-12-31,2022-07-11,ACTUAL,2022-07-11,2022-07-11,ACTUAL,2022-07-11,,INTERVENTIONAL,,,"Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-97489 in Healthy Adult Participants","A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-center, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of CC-97489 in Healthy Adult Subjects",TERMINATED,,PHASE1,84.0,ACTUAL,Celgene,,2.0,,Business objectives changed.,f,,,,f,f,f,,,,,,See Plan Description,See Plan Description,https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,INDUSTRY,,,,,,,2022,0.0
NCT03447262,,2018-02-21,2021-11-09,,2021-12-31,2018-02-21,2018-02-27,ACTUAL,2021-12-31,2022-01-25,ACTUAL,,,,2021-12-31,2022-01-25,ACTUAL,2018-07-13,ACTUAL,2018-07-13,2021-12,2021-12-31,2020-09-09,ACTUAL,2020-09-09,2020-09-09,ACTUAL,2020-09-09,,INTERVENTIONAL,,,A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy,"A Phase 3, Open-label Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation",TERMINATED,,PHASE3,484.0,ACTUAL,Vertex Pharmaceuticals Incorporated,,1.0,,At Sponsor's Discretion,,,,,t,t,f,,,,,,,,,,,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,INDUSTRY,,,,,,,2020,0.0
NCT03226522,,2017-07-20,2023-02-14,,2023-08-22,2017-07-20,2017-07-21,ACTUAL,2023-08-22,2023-09-13,ACTUAL,,,,2023-08-22,2023-09-13,ACTUAL,2017-07-13,ACTUAL,2017-07-13,2023-08,2023-08-31,2020-04-17,ACTUAL,2020-04-17,2020-04-17,ACTUAL,2020-04-17,,INTERVENTIONAL,ADVANCE,,Addressing Dementia Via Agitation-Centered Evaluation,"A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type",COMPLETED,,PHASE2/PHASE3,366.0,ACTUAL,"Axsome Therapeutics, Inc.",,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,INDUSTRY,,,,,,,2020,1.0
NCT05097326,,2021-10-15,2024-04-17,,2024-07-05,2021-10-15,2021-10-28,ACTUAL,2024-07-05,2024-07-31,ACTUAL,,,,2024-07-05,2024-07-31,ACTUAL,2022-06-27,ACTUAL,2022-06-27,2024-07,2024-07-31,2023-04-29,ACTUAL,2023-04-29,2023-04-29,ACTUAL,2023-04-29,,INTERVENTIONAL,MiLI,,Mifepristone for Labor Induction,Mifepristone as an Adjunct to Transcervical Balloon for Labor Induction (MiLI): A Randomized Clinical Trial,COMPLETED,,PHASE3,30.0,ACTUAL,Stanford University,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,OTHER,,,,,,,2023,1.0
NCT05039190,,2021-08-29,,,2023-03-06,2021-09-01,2021-09-09,ACTUAL,,,,,,,2023-03-06,2023-03-08,ACTUAL,2021-09-25,ACTUAL,2021-09-25,2023-03,2023-03-31,2023-01-14,ACTUAL,2023-01-14,2023-01-14,ACTUAL,2023-01-14,,INTERVENTIONAL,MG,,Evaluate the Efficacy and Safety of HBM9161(HL161)Subcutaneous Injection in Patients With Generalized MG Patients,"A Multicenter, Randomized, Double-blind, Placebo-controlled, Seamless and Group Sequential Phase 2/3 Study to Evaluate the Efficacy and Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis",COMPLETED,,PHASE3,132.0,ACTUAL,Harbour BioMed (Guangzhou) Co. Ltd.,,2.0,,,f,,,,,f,f,,,,,,,,,,,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,INDUSTRY,,,,,,,2023,1.0
NCT02867280,,2016-07-10,,,2020-02-09,2016-08-11,2016-08-15,ESTIMATED,,,,,,,2020-02-09,2020-02-11,ACTUAL,2016-06-01,ACTUAL,2016-06-01,2020-02,2020-02-29,2020-01-31,ACTUAL,2020-01-31,2019-08-31,ACTUAL,2019-08-31,,INTERVENTIONAL,,,Sorafenib Treatment in Patients With Hepatocellular Carcinoma With Microvascular Invasion After Radical Resection,A Prospective Multicenter Non-randomized Controlled Study of Sorafenib (Nexavar) Treatment in Patients With Hepatocellular Carcinoma With Microvascular Invasion After Radical Resection,TERMINATED,,PHASE3,154.0,ACTUAL,Sun Yat-sen University,,2.0,,Midterm analysis showed negative results.,f,,,,t,,,,,,,,,,,NO,,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,OTHER,,,,,,,2020,0.0
NCT02924883,,2016-09-21,2018-12-09,,2021-01-28,2016-10-04,2016-10-05,ESTIMATED,2019-01-23,2019-02-12,ACTUAL,,,,2021-01-28,2021-02-17,ACTUAL,2016-09-26,ACTUAL,2016-09-26,2021-01,2021-01-31,2020-02-06,ACTUAL,2020-02-06,2017-12-11,ACTUAL,2017-12-11,,INTERVENTIONAL,KATE2,,A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy,"A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab and Taxane Based Therapy",COMPLETED,,PHASE2,202.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,INDUSTRY,,,,,,,2020,1.0
NCT05205759,,2022-01-15,,,2022-07-24,2022-01-22,2022-01-25,ACTUAL,,,,,,,2022-07-24,2022-07-26,ACTUAL,2021-12-09,ACTUAL,2021-12-09,2022-07,2022-07-31,2022-04-05,ACTUAL,2022-04-05,2022-02-05,ACTUAL,2022-02-05,,INTERVENTIONAL,MANTICO,,Non-inferiority Trial on Monoclonal Antibodies in COVID-19,"Adaptive, Randomized, Non-inferiority Trial to Evaluate the Efficacy of Monoclonal Antibodies in Outpatients With Mild or Moderate COVID-19",TERMINATED,,PHASE3,319.0,ACTUAL,Azienda Ospedaliera Universitaria Integrata Verona,,3.0,,Stop for futility after the onset of the omicron wave,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,OTHER,,,,,,,2022,0.0
NCT03018249,,2017-01-11,2021-03-03,,2021-11-15,2017-01-11,2017-01-12,ESTIMATED,2021-05-05,2021-06-02,ACTUAL,,,,2021-11-15,2021-11-16,ACTUAL,2017-10-11,ACTUAL,2017-10-11,2021-11,2021-11-30,2021-03-12,ACTUAL,2021-03-12,2018-04-18,ACTUAL,2018-04-18,,INTERVENTIONAL,,Eligible patients,Medroxyprogesterone Acetate With or Without Entinostat Before Surgery in Treating Patients With Endometrioid Endometrial Cancer,"A Randomized Surgical Window Pilot Investigation of the Relationship of Short Term Medroxyprogesterone Acetate (NSC #26386) Compared to Medroxyprogesterone Acetate Plus Entinostat (NSC #706995) on the Morphologic, Biochemical, and Molecular Changes in Primary Endometrioid Adenocarcinoma of the Uterine Corpus",COMPLETED,,EARLY_PHASE1,50.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,NIH,,,,,,,2021,1.0
NCT05001022,,2021-08-06,,,2023-04-21,2021-08-06,2021-08-11,ACTUAL,,,,,,,2023-04-21,2023-04-25,ACTUAL,2021-09-25,ACTUAL,2021-09-25,2023-04,2023-04-30,2022-07-18,ACTUAL,2022-07-18,2022-07-18,ACTUAL,2022-07-18,,INTERVENTIONAL,,,"A Study of ALG-020572 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Doses in Healthy Volunteers and Multiple Doses in CHB Subjects","A Phase 1, Double-Blind, Randomized, Placebo-Controlled, First-in-Human Study of Subcutaneously Administered ALG-020572 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Doses in Healthy Volunteers (Part 1) and Multiple Doses in Subjects With Chronic Hepatitis B (Part 2)",TERMINATED,,PHASE1,40.0,ACTUAL,Aligos Therapeutics,,2.0,,ALT flares suggestive of drug induced liver injury,f,,,,,f,f,,,,,,,,,,,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,INDUSTRY,,,,,,,2022,0.0
NCT02995005,,2016-12-08,,,2023-02-03,2016-12-13,2016-12-16,ESTIMATED,,,,,,,2023-02-03,2023-02-06,ACTUAL,2018-05-24,ACTUAL,2018-05-24,2022-10,2022-10-31,2023-01-31,ACTUAL,2023-01-31,2023-01-31,ACTUAL,2023-01-31,,INTERVENTIONAL,,,Tenofovir in Early Pregnancy to Prevent Mother-to-child Transmission of Hepatitis B Virus,"Prevention of Mother-to-child Transmission of Hepatitis B Virus: a One Arm, Open Label Intervention Study to Estimate the Optimal Timing of Tenofovir (TDF) in Pregnancy",COMPLETED,,PHASE1/PHASE2,98.0,ACTUAL,Johns Hopkins Bloomberg School of Public Health,,1.0,,,f,,,,f,f,f,,,f,,,Data will become available 6 months after publication of the main report.,Permission by corresponding author,,YES,The investigators are currently developing an individual participant data (IPD) sharing plan.,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,OTHER,,,,,,,2023,1.0
NCT03251911,,2017-08-14,,,2022-02-01,2017-08-14,2017-08-16,ACTUAL,,,,,,,2022-02-01,2022-02-17,ACTUAL,2020-01-01,ACTUAL,2020-01-01,2022-02,2022-02-28,2022-02-01,ACTUAL,2022-02-01,2022-02-01,ACTUAL,2022-02-01,,INTERVENTIONAL,,,VX-770 for the Treatment of Chronic Bronchitis,An Open Label Study to Investigate the Role of Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis With CFTR Dysfunction,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Alabama at Birmingham,,1.0,,no participants enrolled,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,OTHER,,,,,,,2022,0.0
NCT04680962,,2020-12-02,,,2023-08-03,2020-12-22,2020-12-23,ACTUAL,,,,,,,2023-08-03,2023-08-07,ACTUAL,2023-08-03,ACTUAL,2023-08-03,2023-08,2023-08-31,2023-08-03,ACTUAL,2023-08-03,2023-08-03,ACTUAL,2023-08-03,,INTERVENTIONAL,MABRIDGE,,MabionCD20® Compared to MabThera® and Rituxan® in Patients With Rheumatoid Arthritis,"A Double-Blind, Randomized, Parallel-Group Study to Investigate the Pharmacokinetic and Clinical Similarity Between MabionCD20, EU-approved MabThera® and US-licensed Rituxan® in Patients With Moderate-to-Severe Rheumatoid Arthritis",WITHDRAWN,,PHASE3,0.0,ACTUAL,Mabion SA,,3.0,,Study closed for business reasons before patient recruitment was initiated.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,INDUSTRY,,,,,,,2023,0.0
NCT04088760,,2019-09-12,2023-06-13,,2023-08-16,2019-09-12,2019-09-13,ACTUAL,2023-08-16,2023-09-08,ACTUAL,,,,2023-08-16,2023-09-08,ACTUAL,2019-09-16,ACTUAL,2019-09-16,2023-08,2023-08-31,2021-09-03,ACTUAL,2021-09-03,2021-05-14,ACTUAL,2021-05-14,,INTERVENTIONAL,,,TCRαβ+/CD19+ Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Malignant and Non-malignant Disorders,Safety and Efficacy of TCRαβ+/CD19+ Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Malignant and Non-malignant Disorders in Children and Adolescent/Young Adult Patients,TERMINATED,,PHASE2,15.0,ACTUAL,"Children's Hospital Medical Center, Cincinnati",,1.0,,Post-transplant cyclophosphamide and abatacept can be used as standard-of-care approaches to GVHD prevention in the HLA mismatched donor-recipient setting and are simpler to use since study enrollment is not required.,,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,OTHER,,,,,,,2021,0.0
NCT03661047,,2018-08-31,,,2021-11-10,2018-09-06,2018-09-07,ACTUAL,,,,,,,2021-11-10,2021-11-17,ACTUAL,2019-11-30,ACTUAL,2019-11-30,2021-11,2021-11-30,2021-11-30,ESTIMATED,2021-11-30,2021-11-30,ESTIMATED,2021-11-30,,INTERVENTIONAL,OMICC,,OMega-3 Fatty Acid for the Immune Modulation of Colorectal Cancer,OMICC: OMega-3 Fatty Acid for the Immune Modulation of Colorectal Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,Massachusetts General Hospital,,2.0,,Study will be closed due to zero enrollment in over 2 years.,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,OTHER,,,,,,,2021,0.0
NCT04287543,,2020-02-21,,,2020-07-31,2020-02-25,2020-02-27,ACTUAL,,,,,,,2020-07-31,2020-08-04,ACTUAL,2021-05,ESTIMATED,2021-05-31,2020-07,2020-07-31,2022-08,ESTIMATED,2022-08-31,2022-07,ESTIMATED,2022-07-31,,INTERVENTIONAL,,,Melatonin on Clock Genes in Parkinson's Disease,Effect of Melatonin Administration on the PER1 and BMAL1 Clock Genes in Patients With Parkinson's Disease,WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Instituto Mexicano del Seguro Social,,2.0,,"Due to the COVID-19 pandemic, we were unable to begin the study",f,,,,t,f,f,,,,,,,,,YES,It is planned to inform the patient individually about their results; if the results are favorable it will be considered to apply them to the Clinical of Movement Disorders patients. All data will be published in an article.,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,OTHER_GOV,,,,,,,2022,0.0
NCT03122639,,2017-04-12,,,2024-09-11,2017-04-17,2017-04-21,ACTUAL,,,,,,,2024-09-11,2024-09-19,ACTUAL,2017-09-01,ACTUAL,2017-09-01,2024-09,2024-09-30,2021-05-07,ACTUAL,2021-05-07,2020-01-30,ACTUAL,2020-01-30,,INTERVENTIONAL,,,Endothelial Function in Obstructive Sleep Apnea,Vascular Endothelial Activation in Obstructive Sleep Apnea,COMPLETED,,EARLY_PHASE1,106.0,ACTUAL,Columbia University,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,OTHER,,,,,,,2021,1.0
NCT03820466,,2017-10-02,,,2022-05-17,2019-01-25,2019-01-29,ACTUAL,,,,,,,2022-05-17,2022-05-24,ACTUAL,2020-02-21,ACTUAL,2020-02-21,2022-05,2022-05-31,2022-04-07,ACTUAL,2022-04-07,2021-12-02,ACTUAL,2021-12-02,,INTERVENTIONAL,GRAY-ZONE,,Effect of Platelet Inhibition and / or Lipid Lowering in Non-ACS-patients With Positive Troponin,"Investigator-initiated, Placebo-controlled, Randomized Trial to Assess the Efficacy and Safety of Platelet Inhibition and/ or Lipid Lowering in Non-ACS-patients With Elevated High-sensitivity Troponin Values",TERMINATED,,PHASE3,68.0,ACTUAL,Universitätsklinikum Hamburg-Eppendorf,,4.0,,insufficient recruitment due to the pandemic situation,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,OTHER,,,,,,,2022,0.0
NCT05568225,,2022-09-15,,,2024-09-11,2022-09-30,2022-10-05,ACTUAL,,,,,,,2024-09-11,2024-09-19,ACTUAL,2022-11-22,ACTUAL,2022-11-22,2024-09,2024-09-30,2024-07-15,ACTUAL,2024-07-15,2024-07-15,ACTUAL,2024-07-15,,INTERVENTIONAL,,,A Study of Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS),A Phase 2 Open-Label Study to Evaluate Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS),TERMINATED,,PHASE2,17.0,ACTUAL,Novo Nordisk A/S,,1.0,,Futility assessment concluded low likelihood of the trial showing meaningful patient benefit.,f,,,,,t,f,,,,,,,,,,,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,INDUSTRY,,,,,,,2024,0.0
NCT05682170,,2022-12-19,,,2024-09-12,2023-01-03,2023-01-12,ACTUAL,,,,,,,2024-09-12,2024-09-19,ACTUAL,2022-12-01,ACTUAL,2022-12-01,2024-09,2024-09-30,2024-07-26,ACTUAL,2024-07-26,2024-07-02,ACTUAL,2024-07-02,,INTERVENTIONAL,,,Study of the ZN-d5 and ZN-c3 in Subjects With Acute Myeloid Leukemia (AML),A Phase 1/2 Dose Escalation Study of the BCL-2 Inhibitor ZN-d5 and the WEE1 Inhibitor ZN-c3 in Subjects With Acute Myeloid Leukemia,TERMINATED,,PHASE1/PHASE2,40.0,ACTUAL,"K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.",,1.0,,Sponsor decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,INDUSTRY,,,,,,,2024,0.0
NCT06165809,,2023-12-04,,,2023-12-26,2023-12-04,2023-12-12,ACTUAL,,,,,,,2023-12-26,2023-12-29,ACTUAL,2023-12,ESTIMATED,2023-12-31,2023-12,2023-12-31,2024-05,ESTIMATED,2024-05-31,2024-05,ESTIMATED,2024-05-31,,INTERVENTIONAL,,,A Clinical Trial of TQB3015 Tablets in Patients With Advanced Malignant Cancer,A Phase I Study to Evaluate the Safety and Tolerance of TQB3015 Tablets With Advanced Malignant Cancer.,WITHDRAWN,,PHASE1,0.0,ACTUAL,"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",,1.0,,The sponsor voluntarily withdraw the project.,f,,,,,f,f,,,,,,,,,,,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,INDUSTRY,,,,,,,2024,0.0
NCT03693430,,2018-10-01,2022-02-02,,2023-07-05,2018-10-01,2018-10-03,ACTUAL,2022-03-21,2022-03-23,ACTUAL,,,,2023-07-05,2023-07-06,ACTUAL,2018-10-05,ACTUAL,2018-10-05,2023-07,2023-07-31,2021-03-23,ACTUAL,2021-03-23,2021-01-29,ACTUAL,2021-01-29,,INTERVENTIONAL,STEP 5,The full analysis set (FAS) included all randomised participants according to the intention-to-treat principle.,Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity,Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity,COMPLETED,,PHASE3,304.0,ACTUAL,Novo Nordisk A/S,,2.0,,,f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,INDUSTRY,,,,,,,2021,1.0
NCT04802161,,2021-03-16,,,2024-08-09,2021-03-16,2021-03-17,ACTUAL,,,,,,,2024-08-09,2024-08-12,ACTUAL,2022-08-24,ACTUAL,2022-08-24,2024-08,2024-08-31,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,"Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes",Randomized Phase 2 Study of Daunorubicin and Cytarabine Liposome + Pomalidomide Versus Daunorubicin and Cytarabine Liposome in Newly Diagnosed AML With MDS-Related Changes,SUSPENDED,,PHASE2,78.0,ESTIMATED,National Cancer Institute (NCI),,2.0,,Other - Pending amendment and futility analysis.,f,,,,f,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.",2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,NIH,,,,,,,2024,0.0
NCT04663321,,2020-12-04,2024-08-26,,2024-08-26,2020-12-04,2020-12-11,ACTUAL,2024-08-26,2024-09-19,ACTUAL,,,,2024-08-26,2024-09-19,ACTUAL,2021-05-20,ACTUAL,2021-05-20,2024-08,2024-08-31,2023-09-08,ACTUAL,2023-09-08,2023-09-08,ACTUAL,2023-09-08,,INTERVENTIONAL,,,Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006),"A Phase 2a, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-1942 Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression",TERMINATED,,PHASE2,99.0,ACTUAL,Merck Sharp & Dohme LLC,,3.0,,Voluntarily terminated due to benefit/risk assessment,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,INDUSTRY,,,,,,,2023,0.0
NCT05200143,,2022-01-06,2024-07-25,,2024-08-21,2022-01-06,2022-01-20,ACTUAL,2024-08-21,2024-09-19,ACTUAL,,,,2024-08-21,2024-09-19,ACTUAL,2022-06-08,ACTUAL,2022-06-08,2024-08,2024-08-31,2024-07-23,ACTUAL,2024-07-23,2023-09-11,ACTUAL,2023-09-11,,INTERVENTIONAL,,,"Study of Ipilimumab, Nivolumab, and Cabozantinib in Patients With Cutaneous Melanoma","A Phase II, Single-Arm Clinical Trial Evaluating the Triplet Combination of Ipilimumab, Nivolumab, and Cabozantinib in Patients With Anti-PD-1(L1) Refractory Cutaneous Melanoma",TERMINATED,,PHASE2,4.0,ACTUAL,Providence Health & Services,,1.0,,Withdrawn support from BMS.,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,OTHER,,,,,,,2024,0.0
NCT06114121,,2023-10-27,,,2024-09-06,2023-10-27,2023-11-02,ACTUAL,,,,,,,2024-09-06,2024-09-19,ACTUAL,2024-07-10,ESTIMATED,2024-07-10,2024-09,2024-09-30,2024-09-10,ESTIMATED,2024-09-10,2024-09-10,ESTIMATED,2024-09-10,,INTERVENTIONAL,,,Intrathecal Morphine vs. Intrathecal Morphine and Regional Anesthesia After Cesarean Section.,Comparing Intrathecal Morphine and Erector Spinae Plane Regional Anesthesia Against Intrathecal Morphine Alone for Post-Cesarean Section Pain,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of Miami,,2.0,,Study will no longer be conducted,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,OTHER,,,,,,,2024,0.0
NCT03346434,,2017-02-06,2022-06-14,,2022-07-27,2017-11-14,2017-11-17,ACTUAL,2022-07-27,2022-07-28,ACTUAL,,,,2022-07-27,2022-07-28,ACTUAL,2017-11-30,ACTUAL,2017-11-30,2022-07,2022-07-31,2021-07-08,ACTUAL,2021-07-08,2021-07-08,ACTUAL,2021-07-08,,INTERVENTIONAL,Liberty AD,,"Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL)","A Phase 2/3 Study Investigating the Pharmacokinetics, Safety, and Efficacy of Dupilumab in Patients Aged ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis",COMPLETED,,PHASE2/PHASE3,202.0,ACTUAL,Regeneron Pharmaceuticals,,4.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,INDUSTRY,,,,,,,2021,1.0
NCT03952143,,2019-05-14,2022-01-11,,2022-01-11,2019-05-14,2019-05-16,ACTUAL,2022-01-11,2022-02-08,ACTUAL,,,,2022-01-11,2022-02-08,ACTUAL,2019-05-27,ACTUAL,2019-05-27,2022-01,2022-01-31,2021-01-20,ACTUAL,2021-01-20,2021-01-20,ACTUAL,2021-01-20,,INTERVENTIONAL,,All randomized participants.,A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes,"A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes",COMPLETED,,PHASE3,628.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,f,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,INDUSTRY,,,,,,,2021,1.0
NCT04199351,,2019-12-12,2024-04-26,,2024-04-26,2019-12-12,2019-12-13,ACTUAL,2024-04-26,2024-09-19,ACTUAL,,,,2024-04-26,2024-09-19,ACTUAL,2019-12-13,ACTUAL,2019-12-13,2024-04,2024-04-30,2021-09-10,ACTUAL,2021-09-10,2021-09-10,ACTUAL,2021-09-10,,INTERVENTIONAL,,,Single and Multiple Ascending Dose Study of AMG 171 in Subjects With Obesity,"A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 171 in Subjects With Obesity",TERMINATED,,PHASE1,60.0,ACTUAL,Amgen,,3.0,,Amgen determined the totality of the data does not support continuation of AMG 171 development program for treatment of Obesity. No safety concerns identified.,,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a datasharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,INDUSTRY,,,,,,,2021,0.0
NCT03737123,,2018-11-08,2022-11-17,,2023-08-31,2018-11-08,2018-11-09,ACTUAL,2023-08-31,2023-09-13,ACTUAL,,,,2023-08-31,2023-09-13,ACTUAL,2018-12-19,ACTUAL,2018-12-19,2023-08,2023-08-31,2022-05-18,ACTUAL,2022-05-18,2022-03-08,ACTUAL,2022-03-08,,INTERVENTIONAL,,No subject had been enrolled in arm B of Phase II,Trial of Atezolizumab Plus Chemotherapy After Progression on PD-1 or PD-L1 in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma,A Phase II Trial of Atezolizumab Plus Chemotherapy After Progression on PD-1 or PD-L1 Inhibitor in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma: HCRN GU17-295,TERMINATED,,PHASE2,6.0,ACTUAL,Hoosier Cancer Research Network,,1.0,,Lack of accrual,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,OTHER,,,,,,,2022,0.0
NCT03604978,,2018-07-27,,,2024-09-11,2018-07-27,2018-07-30,ACTUAL,,,,,,,2024-09-11,2024-09-19,ACTUAL,2019-06-17,ACTUAL,2019-06-17,2024-09,2024-09-30,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Nivolumab and Multi-fraction Stereotactic Radiosurgery With or Without Ipilimumab in Treating Patients With Recurrent Grade II-III Meningioma,A Phase I/II Study of Nivolumab Plus or Minus Ipilimumab in Combination With Multi-Fraction Stereotactic Radiosurgery for Recurrent High-Grade Radiation-Relapsed Meningioma,SUSPENDED,,PHASE1/PHASE2,38.0,ESTIMATED,National Cancer Institute (NCI),,2.0,,Scheduled Interim Monitoring,f,,,,f,t,f,,,,,,,,,,,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,NIH,,,,,,,2024,0.0
NCT05317078,,2022-03-30,,,2024-07-05,2022-03-30,2022-04-07,ACTUAL,,,,,,,2024-07-05,2024-07-08,ACTUAL,2023-02-28,ACTUAL,2023-02-28,2024-07,2024-07-31,2023-12-19,ACTUAL,2023-12-19,2023-12-19,ACTUAL,2023-12-19,,INTERVENTIONAL,,,"A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications","Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 794 in Participants With Claudin 6-positive Advanced/Metastatic Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications",TERMINATED,,PHASE1,3.0,ACTUAL,Amgen,,2.0,,Amgen has made the business decision to discontinue development of AMG 794. The safety profile of AMG 794 remains unchanged.,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2 ) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 15:06:22.911405,2024-10-16 15:06:22.911405,INDUSTRY,,,,,,,2023,0.0
NCT04986072,,2021-07-23,,,2024-08-09,2021-07-23,2021-08-02,ACTUAL,,,,,,,2024-08-09,2024-08-12,ACTUAL,2022-03-14,ACTUAL,2022-03-14,2024-08,2024-08-31,2024-07-01,ACTUAL,2024-07-01,2024-06-01,ACTUAL,2024-06-01,,INTERVENTIONAL,,,Sodium Nitroprusside in Early Course Schizophrenia,Proof of Mechanism Study Using a Retinal Biomarker to Predict Treatment Response With Intravenous Sodium Nitroprusside in Symptomatic Early Course Schizophrenia,TERMINATED,,PHASE2,1.0,ACTUAL,Beth Israel Deaconess Medical Center,,2.0,,Difficulty with recruiting subjects for the study,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,OTHER,,,,,,,2024,0.0
NCT02177695,,2014-06-11,2021-06-28,,2024-08-26,2014-06-25,2014-06-30,ESTIMATED,2021-12-03,2022-01-03,ACTUAL,,,,2024-08-26,2024-09-19,ACTUAL,2014-08-28,ACTUAL,2014-08-28,2024-08,2024-08-31,2022-12-01,ACTUAL,2022-12-01,2020-02,ACTUAL,2020-02-29,,INTERVENTIONAL,COXEN,All eligible participants,"S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer","A Randomized Phase II Study of Co-Expression Extrapolation (COXEN) With Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer",COMPLETED,,PHASE2,237.0,ACTUAL,SWOG Cancer Research Network,,2.0,,,f,,,,t,,,,,,,,Indefinite,NCTN/NCORP Data Archive registration,http://nctn-data-archive.nci.nih.gov/,YES,Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,NETWORK,,,,,,,2022,1.0
NCT03576885,,2018-06-22,,,2024-07-31,2018-06-22,2018-07-03,ACTUAL,,,,,,,2024-07-31,2024-08-01,ACTUAL,2019-07-15,ACTUAL,2019-07-15,2024-07,2024-07-31,2023-10-09,ACTUAL,2023-10-09,2023-10-09,ACTUAL,2023-10-09,,INTERVENTIONAL,,,Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia,Treatment of Delayed Pulmonary Transition in Extremely Preterm Infants & Bronchopulmonary Dysplasia,TERMINATED,,PHASE1/PHASE2,182.0,ACTUAL,AdventHealth,,3.0,,based on DSMB recommendation at interim analysis,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,OTHER,,,,,,,2023,0.0
NCT05291520,,2022-02-16,2024-04-09,,2024-04-09,2022-03-11,2022-03-22,ACTUAL,2024-04-09,2024-09-19,ACTUAL,,,,2024-04-09,2024-09-19,ACTUAL,2022-02-23,ACTUAL,2022-02-23,2024-04,2024-04-30,2023-04-10,ACTUAL,2023-04-10,2023-04-10,ACTUAL,2023-04-10,,INTERVENTIONAL,SPAN,,"A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants","A Phase 1, Open-Label, Single-Dose Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, GSK3810109, Administered Either Subcutaneously or Intravenously With Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults",COMPLETED,,PHASE1,24.0,ACTUAL,ViiV Healthcare,,3.0,,,f,,,,f,t,f,,,,,,"IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.","Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.",,YES,IPD for this study will be made available via the Clinical Study Data Request site.,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,INDUSTRY,,,,,,,2023,1.0
NCT04244253,,2020-01-23,2023-02-02,,2024-05-13,2020-01-26,2020-01-28,ACTUAL,2024-05-13,2024-09-19,ACTUAL,,,,2024-05-13,2024-09-19,ACTUAL,2020-03-03,ACTUAL,2020-03-03,2024-05,2024-05-31,2022-02-25,ACTUAL,2022-02-25,2022-02-08,ACTUAL,2022-02-08,,INTERVENTIONAL,,The safety analysis set includes all subjects who were administered at least 1 dose of double-blind IMP.,A Phase 2 Trial of OPC-64005 for Major Depressive Disorder,"A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison Trial to Assess Efficacy and Safety of OPC-64005 in Patients With Major Depressive Disorder",COMPLETED,,PHASE2,273.0,ACTUAL,"Otsuka Pharmaceutical Co., Ltd.",,3.0,,,f,,,,f,f,f,,,,,,"Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.",Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.,,YES,Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,INDUSTRY,,,,,,,2022,1.0
NCT05526716,,2022-08-31,2024-06-12,,2024-09-09,2022-08-31,2022-09-02,ACTUAL,2024-08-29,2024-09-05,ACTUAL,,,,2024-09-09,2024-09-19,ACTUAL,2022-09-23,ACTUAL,2022-09-23,2024-09,2024-09-30,2023-06-21,ACTUAL,2023-06-21,2023-06-21,ACTUAL,2023-06-21,,INTERVENTIONAL,,All vaccinated participants are included.,"A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)","A Phase 3 Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older",COMPLETED,,PHASE3,1080.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,INDUSTRY,,,,,,,2023,1.0
NCT05773664,,2023-01-30,,,2024-09-17,2023-03-06,2023-03-17,ACTUAL,,,,,,,2024-09-17,2024-09-19,ACTUAL,2024-11-15,ESTIMATED,2024-11-15,2024-09,2024-09-30,2024-11-29,ESTIMATED,2024-11-29,2024-11-29,ESTIMATED,2024-11-29,,INTERVENTIONAL,,,Dexamethasone and Azeliragon for Management of Post-Resection Cerebral Edema in Patients with Glioblastoma,A Phase I De-Escalation Study of Dexamethasone with Azeliragon for Management of Post-Resection Cerebral Edema in Patients with Glioblastoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,City of Hope Medical Center,,2.0,,Funding,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,OTHER,,,,,,,2024,0.0
NCT04915846,,2021-05-06,,,2024-09-13,2021-06-04,2021-06-07,ACTUAL,,,,,,,2024-09-13,2024-09-19,ACTUAL,2020-12-18,ACTUAL,2020-12-18,2024-03,2024-03-31,2024-05-09,ACTUAL,2024-05-09,2024-05-09,ACTUAL,2024-05-09,,INTERVENTIONAL,TAM4MTM,,Tamoxifen Therapy for Myotubular Myopathy,"TAM4MTM: a Phase 1/2 Randomized, Placebo-Controlled, Double-Blinded, Single Crossover Study to Determine the Safety and Efficacy of Tamoxifen Therapy for Myotubular Myopathy (XLMTM)",TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,The Hospital for Sick Children,,2.0,,Study terminated due to safety concerns.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 03:36:42.981541,2024-10-15 03:36:42.981541,OTHER,,,,,,,2024,0.0
NCT04079088,,2019-09-03,,,2023-05-31,2019-09-03,2019-09-06,ACTUAL,,,,,,,2023-05-31,2023-06-01,ACTUAL,2021-06-30,ESTIMATED,2021-06-30,2023-05,2023-05-31,2024-09-18,ESTIMATED,2024-09-18,2024-09-18,ESTIMATED,2024-09-18,,INTERVENTIONAL,,,Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS),"A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis",WITHDRAWN,,PHASE2,0.0,ACTUAL,Biogen,,4.0,,"Decision to discontinue BIIB061 program was based on lack of stronger preclinical effects of BIIB061 on remyelination relative to opicinumab, that showed limited clinical efficacy in phase 2 clinical studies. This was not related to safety concerns.",f,,,,t,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,INDUSTRY,,,,,,,2024,0.0
NCT01644253,,2012-07-12,,,2021-05-18,2012-07-16,2012-07-19,ESTIMATED,,,,,,,2021-05-18,2021-05-20,ACTUAL,2012-09,ACTUAL,2012-09-30,2021-05,2021-05-31,2021-04-21,ACTUAL,2021-04-21,2020-02-24,ACTUAL,2020-02-24,,INTERVENTIONAL,,,Phase 1b Safety and Efficacy Study of TRU-016,"Phase 1b, Open Label Study to Evaluate Safety and Efficacy of TRU-016 in Combination With Rituximab, Obinutuzumab, Rituximab and Idelalisib, or Ibrutinib in Chronic Lymphocytic Leukemia and With Bendamustine in Peripheral T-cell Lymphoma",TERMINATED,,PHASE1,87.0,ACTUAL,Aptevo Therapeutics,,8.0,,Business decision,f,,,,f,,,,,,,,,,,,,2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,INDUSTRY,,,,,,,2021,0.0
NCT03351244,,2017-11-20,2022-03-09,,2022-04-19,2017-11-20,2017-11-22,ACTUAL,2022-03-09,2022-04-04,ACTUAL,,,,2022-04-19,2022-05-12,ACTUAL,2017-12-07,ACTUAL,2017-12-07,2022-04,2022-04-30,2021-03-31,ACTUAL,2021-03-31,2021-03-10,ACTUAL,2021-03-10,,INTERVENTIONAL,,Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.,This Study Tests Whether BI 409306 Prevents Patients With Schizophrenia From Becoming Worse. This Study Looks at How Well Patients Tolerate BI 409306 and How Effective it is Over 6 Months,"A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered BI 409306 During a 28-week Treatment Period as Adjunctive Therapy to Antipsychotic Treatment for the Prevention of Relapse in Patients With Schizophrenia.",TERMINATED,,PHASE2,264.0,ACTUAL,Boehringer Ingelheim,The study was terminated due to sponsor decision. The planned number of participants to be recruited was not reached.,3.0,,disruption due to COVID-19,f,,,,f,t,f,,,,,,,,,,,2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,INDUSTRY,,,,,,,2021,0.0
NCT04423718,,2020-06-08,2023-07-09,,2024-09-05,2020-06-08,2020-06-09,ACTUAL,2023-08-11,2023-09-06,ACTUAL,,,,2024-09-05,2024-09-19,ACTUAL,2020-08-11,ACTUAL,2020-08-11,2024-09,2024-09-30,2024-08-07,ACTUAL,2024-08-07,2022-07-27,ACTUAL,2022-07-27,,INTERVENTIONAL,PULSAR,Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.,Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye,"Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration",COMPLETED,,PHASE3,1011.0,ACTUAL,Bayer,,3.0,,,f,,,,t,t,f,,,t,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,INDUSTRY,,,,,,,2024,1.0
NCT03532542,,2018-05-10,2024-07-24,,2024-09-13,2018-05-10,2018-05-22,ACTUAL,2024-09-13,2024-09-19,ACTUAL,,,,2024-09-13,2024-09-19,ACTUAL,2018-08-02,ACTUAL,2018-08-02,2024-09,2024-09-30,2023-07-26,ACTUAL,2023-07-26,2023-07-26,ACTUAL,2023-07-26,,INTERVENTIONAL,,Safety Analysis Set: All enrolled participants who received at least 1 dose of study drug (golodirsen or casimersen).,An Extension Study to Evaluate Casimersen or Golodirsen in Patients With Duchenne Muscular Dystrophy,"Long-term, Open-label Extension Study for Patients With Duchenne Muscular Dystrophy Enrolled in Clinical Trials Evaluating Casimersen or Golodirsen",TERMINATED,,PHASE3,171.0,ACTUAL,"Sarepta Therapeutics, Inc.","This study was terminated before all participants had reached the last protocol-defined end-of-study visit. Study termination resulted in participants either being transitioned to a post-trial access program, to another study, or they declined further treatment.",2.0,,The trial was stopped to reduce the clinical trial burden on participants while ensuring continued treatment via a post-trial access program with commercially available casimersen and golodirsen. Study was not terminated due to safety concerns.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,INDUSTRY,,,,,,,2023,0.0
NCT04913610,,2021-05-30,2024-08-19,,2024-08-19,2021-05-30,2021-06-04,ACTUAL,2024-08-19,2024-09-19,ACTUAL,,,,2024-08-19,2024-09-19,ACTUAL,2021-05-22,ACTUAL,2021-05-22,2024-08,2024-08-31,2023-08-29,ACTUAL,2023-08-29,2023-08-29,ACTUAL,2023-08-29,,INTERVENTIONAL,,Intention-to-Treat (ITT) population includes all randomized participants who received at least one dose of study drug,"Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-4083 Capsules When Given Alone or In Combination With Albendazole Capsules Moves in The Body of Adult Participants With Onchocerca Volvulus Infection","A Phase-II, Randomised, Double-blind, Parallel-group, Proof-of-concept Trial to Investigate ABBV-4083 Given for 7 or 14 Days or in Combination With Albendazole in Subjects With Onchocerca Volvulus Infection, Comprising: Part 1 to Investigate Safety, Tolerability, Efficacy for Dose-Ranging and Pharmacokinetics; Part 2 to Investigate Efficacy of Selected Doses, Safety, Tolerability and Pharmacokinetics",TERMINATED,,PHASE2,153.0,ACTUAL,AbbVie,,5.0,,Strategic considerations,f,,,,t,t,f,,,f,,,,,,NO,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,INDUSTRY,,,,,,,2023,0.0
NCT05289492,,2022-03-11,,,2024-09-06,2022-03-18,2022-03-21,ACTUAL,,,,,,,2024-09-06,2024-09-19,ACTUAL,2022-05-01,ACTUAL,2022-05-01,2024-03,2024-03-31,2023-11-29,ACTUAL,2023-11-29,2023-11-29,ACTUAL,2023-11-29,,INTERVENTIONAL,,,Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma,"Study of EOS884448 Alone, and in Combination with Iberdomide with or Without Dexamethasone, in Participants with Relapsed or Refractory Multiple Myeloma",TERMINATED,,PHASE1/PHASE2,16.0,ACTUAL,iTeos Therapeutics,,3.0,,Company operational decision. Decision to stop study is not due to safety or efficacy concerns,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,INDUSTRY,,,,,,,2023,0.0
NCT04418024,,2020-05-22,,,2024-09-11,2020-06-01,2020-06-05,ACTUAL,,,,,,,2024-09-11,2024-09-19,ACTUAL,2020-10-21,ACTUAL,2020-10-21,2021-06,2021-06-30,2024-04-30,ESTIMATED,2024-04-30,2024-03-31,ESTIMATED,2024-03-31,,INTERVENTIONAL,ATTRibute-PN,,Efficacy and Safety of AG10 in Subjects with Transthyretin Amyloid Polyneurophathy,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial)",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Eidos Therapeutics, a BridgeBio company",,2.0,,"After a careful review of the currently available treatments worldwide for patients with ATTR-polyneuropathy, Eidos has made the decision to halt the current study design.",f,,,,t,t,f,,,t,,,,,,,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,INDUSTRY,,,,,,,2024,0.0
NCT05280717,,2022-03-04,2024-04-04,,2024-04-04,2022-03-04,2022-03-15,ACTUAL,2024-04-04,2024-09-19,ACTUAL,,,,2024-04-04,2024-09-19,ACTUAL,2022-03-28,ACTUAL,2022-03-28,2024-04,2024-04-30,2023-11-06,ACTUAL,2023-11-06,2023-04-05,ACTUAL,2023-04-05,,INTERVENTIONAL,COSMIC,"Part B was not initiated in alignment with the strategic direction of the sotrovimab program and Part C Cohort-2 was not conducted as Part C Cohort-1 was stopped for programmatic reasons given the evolving Corona virus disease-19 (COVID-19) variant landscape. Hence, no participants were enrolled in Part B and Part C (Cohort-2). Baseline Characteristic data are reported for Safety Population.","Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)","A Phase 1, Open-label, Randomized, Parallel Group, Single-dose Clinical Pharmacology Study to Investigate the Relative Bioavailability, Safety, and Tolerability of Two Different Concentrations of Sotrovimab Administered at Different Injection Sites, in Male or Female Healthy Participants Aged 18 to 65 Years",TERMINATED,,PHASE1,316.0,ACTUAL,"Vir Biotechnology, Inc.",,7.0,,Part C cohort 1 was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,INDUSTRY,,,,,,,2023,0.0
NCT03796273,,2018-12-26,,,2024-09-12,2019-01-03,2019-01-08,ACTUAL,,,,,,,2024-09-12,2024-09-19,ACTUAL,2019-03-13,ACTUAL,2019-03-13,2024-09,2024-09-30,2022-10-23,ACTUAL,2022-10-23,2022-10-23,ACTUAL,2022-10-23,,INTERVENTIONAL,,,Ketoconazole Before Surgery in Treating Patients With Recurrent Glioma or Breast Cancer Brain Metastases,tGLI1 as a Therapeutic Target in Brain Metastases: A Window of Opportunity Study in Breast Cancer Brain Metastases and Primary Gliomas,TERMINATED,,EARLY_PHASE1,15.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,Low accruals,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,OTHER,,,,,,,2022,0.0
NCT04943744,,2021-06-21,,,2024-09-03,2021-06-21,2021-06-29,ACTUAL,,,,,,,2024-09-03,2024-09-19,ACTUAL,2021-05-17,ACTUAL,2021-05-17,2024-09,2024-09-30,2024-05-17,ACTUAL,2024-05-17,2024-05-17,ACTUAL,2024-05-17,,INTERVENTIONAL,STRING,,Gastrointestinal STRING Test With Oral Immunotherapy,Monitoring Gastrointestinal Responses In Food Oral Immunotherapy Using the Esophageal STRING Test,TERMINATED,,EARLY_PHASE1,13.0,ACTUAL,Stanford University,,3.0,,Parent study closed to enrollment,f,,,,f,t,t,,,,,,,,,NO,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,OTHER,,,,,,,2024,0.0
NCT04327206,,2020-03-25,,,2024-09-09,2020-03-27,2020-03-31,ACTUAL,,,,,,,2024-09-09,2024-09-19,ACTUAL,2020-03-30,ACTUAL,2020-03-30,2024-07,2024-07-31,2022-05-27,ACTUAL,2022-05-27,2021-11-10,ACTUAL,2021-11-10,,INTERVENTIONAL,BRACE,,BCG Vaccination to Protect Healthcare Workers Against COVID-19,BCG Vaccination to Reduce the Impact of COVID-19 in Healthcare Workers (BRACE) Trial,COMPLETED,,PHASE3,6828.0,ACTUAL,Murdoch Childrens Research Institute,,2.0,,,f,,,,,f,f,,,,,,"After database lock, a 12-month embargo period will be in place, to allow adequate time for analyses and publication outputs. Data transfer to Vivli should occur during the embargo period.","Researchers from a recognised research institution can approach MCRI for access of data.~The researcher will need to provide evidence that the proposed use of the data has been ethically reviewed and approved by an Institutional Review Board (IRB)/ Human Research Ethics Committee(HREC), and accept MCRI's conditions, under a collaborator agreement.",https://www.melbournechildrens.com/mctc/,YES,"Under the terms of the funding agreement with the Bill and Melinda Gates foundation, the BRACE trial has a data sharing agreement in place.~An anonymised Individual Participant Data (IPD) dataset and a data dictionary will be provided to Vivli (https://vivli.org/) under the terms of the agreements with the Bill and Melinda Gates foundation grant and Vivli.~After database lock, the following may be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions, under a collaborator agreement, for accessing:~* Individual participant data that underlie the results reported in our articles after deidentification (text, tables, figures and appendices)~* Study protocol, Statistical Analysis Plan, PICF",2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,OTHER,,,,,,,2022,0.0
NCT04218240,,2020-01-02,2024-03-12,,2024-08-27,2020-01-02,2020-01-06,ACTUAL,2024-05-13,2024-05-20,ACTUAL,,,,2024-08-27,2024-09-19,ACTUAL,2020-12-17,ACTUAL,2020-12-17,2024-05,2024-05-31,2023-08-31,ACTUAL,2023-08-31,2023-08-31,ACTUAL,2023-08-31,,INTERVENTIONAL,PGB-LOF,"males and females who are 18+ years of age, opioid use disorder",Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal,Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM): Can it Increase the Success of Transition to Naltrexone?,COMPLETED,,PHASE2,90.0,ACTUAL,University of Pennsylvania,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,Not at this time,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,OTHER,,,,,,,2023,1.0
NCT01666249,,2012-07-25,,,2022-11-01,2012-08-10,2012-08-16,ESTIMATED,,,,,,,2022-11-01,2022-11-02,ACTUAL,2014-04,ACTUAL,2014-04-30,2022-11,2022-11-30,2020-12,,2020-12-31,2014-11,ACTUAL,2014-11-30,,INTERVENTIONAL,,,Clinical Efficacy of Postpartum Immunization of Rh and Coombs Negative Women With Sensitization Risk.,Evaluation of the Clinic Efficacy of Immunoglobulin Anti-RhD KamRho-D® (Panamerican) in Postpartum Immunization of Rh and Coombs Negative Women at Sensitization Risk.,SUSPENDED,,PHASE3,347.0,ESTIMATED,Azidus Brasil,,1.0,,Suspended for indetermined period.,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,INDUSTRY,,,,,,,2020,0.0
NCT05238675,,2022-02-03,,,2024-09-16,2022-02-03,2022-02-14,ACTUAL,,,,,,,2024-09-16,2024-09-19,ACTUAL,2022-03-21,ACTUAL,2022-03-21,2024-09,2024-09-30,2024-05-30,ACTUAL,2024-05-30,2024-05-01,ACTUAL,2024-05-01,,INTERVENTIONAL,,,A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis,"A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study Evaluating Efficacy, Safety and Tolerability of BI 1291583 qd Over at Least 24 Weeks in Patients With Bronchiectasis (AirleafTM)",COMPLETED,,PHASE2,322.0,ACTUAL,Boehringer Ingelheim,,4.0,,,f,,,,t,t,f,,,,,,"After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.","For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.",https://www.mystudywindow.com/msw/datasharing,YES,"After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link http://trials.boehringeringelheim.com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.",2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,INDUSTRY,,,,,,,2024,1.0
NCT04949191,,2021-06-25,2024-06-10,,2024-08-16,2021-06-25,2021-07-02,ACTUAL,2024-08-16,2024-09-19,ACTUAL,,,,2024-08-16,2024-09-19,ACTUAL,2021-07-08,ACTUAL,2021-07-08,2024-08,2024-08-31,2024-04-11,ACTUAL,2024-04-11,2024-04-11,ACTUAL,2024-04-11,,INTERVENTIONAL,,The 6 mg (n=2) and 13.5 mg (n=2) monotherapy groups have been combined into a single arm retain participant privacy and reduce the risk of participant re-identification.,The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies.,"An Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib",TERMINATED,,PHASE2,10.0,ACTUAL,Incyte Corporation,,3.0,,A business decision due to availability of commercial drug and other options for accessing study drug treatment.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,INDUSTRY,,,,,,,2024,0.0
NCT03562195,,2018-05-22,2023-09-05,,2024-04-15,2018-06-07,2018-06-19,ACTUAL,2024-04-15,2024-09-19,ACTUAL,,,,2024-04-15,2024-09-19,ACTUAL,2018-08-29,ACTUAL,2018-08-29,2024-04,2024-04-30,2022-09-07,ACTUAL,2022-09-07,2022-09-07,ACTUAL,2022-09-07,,INTERVENTIONAL,,,A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma,"A Randomized, Double Blind, Parallel Group Study of the Efficacy and Safety of Mepolizumab as Adjunctive Therapy in Patients With Severe Asthma With Eosinophilic Inflammation",COMPLETED,,PHASE3,300.0,ACTUAL,GlaxoSmithKline,,2.0,,,f,,,,f,f,f,,,,,,"Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.",https://www.gsk.com/en-gb/innovation/trials/data-transparency,YES,Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,INDUSTRY,,,,,,,2022,1.0
NCT04090203,,2019-05-30,2023-08-15,,2024-09-03,2019-09-12,2019-09-16,ACTUAL,2024-09-03,2024-09-19,ACTUAL,,,,2024-09-03,2024-09-19,ACTUAL,2019-11-05,ACTUAL,2019-11-05,2024-09,2024-09-30,2021-05-20,ACTUAL,2021-05-20,2021-05-20,ACTUAL,2021-05-20,,INTERVENTIONAL,BPOIT,,Boiled Peanut Oral Immunotherapy,Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergic Pediatric Patients,COMPLETED,,PHASE1,8.0,ACTUAL,The Cleveland Clinic,"Enrollment was paused due to institutional IRB regulations during the COVID-19 pandemic. After resumption of enrollment, the study proceeded as planned.",1.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,OTHER,,,,,,,2021,1.0
NCT04984616,,2021-06-29,,,2024-09-06,2021-07-21,2021-07-30,ACTUAL,,,,,,,2024-09-06,2024-09-19,ACTUAL,2021-10-12,ACTUAL,2021-10-12,2023-05,2023-05-31,2024-04-01,ACTUAL,2024-04-01,2024-03-31,ACTUAL,2024-03-31,,INTERVENTIONAL,ATOCHA,,Atorvastatin on Inflammation and Cardiac Function in Chronic Chagas Disease,Effect of Statins (Atorvastatin) on Inflammation and Cardiac Function in Patients with Chronic Chagas Disease: Pathophysiological Studies in a Multicenter Proof-of-concept,TERMINATED,,PHASE2,300.0,ACTUAL,University of Chile,,3.0,,The recruitment rate in all centers was extremely low. The number of participants failed to reach a statistically significant minimum.,f,,,,f,f,f,,,f,,,,,,UNDECIDED,The study protocol and the Clinical Study Report will be available as supporting information alongside all publications derived from this study.~By incorporating the Individual Participant Data on a repository after an embargo period of one year after the last patient is recruited,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,OTHER,,,,,,,2024,0.0
NCT05131204,,2021-11-12,2024-07-09,,2024-08-22,2021-11-12,2021-11-23,ACTUAL,2024-08-22,2024-09-19,ACTUAL,,,,2024-08-22,2024-09-19,ACTUAL,2022-10-06,ACTUAL,2022-10-06,2024-08,2024-08-31,2023-07-12,ACTUAL,2023-07-12,2023-07-12,ACTUAL,2023-07-12,,INTERVENTIONAL,ACCESS 2,,Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria,"A Randomized, Open-Label, Eculizumab and Ravulizumab Controlled Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Currently Treated With Eculizumab or Ravulizumab",TERMINATED,,PHASE3,3.0,ACTUAL,Regeneron Pharmaceuticals,"20Dec2022 - Due to feasibility challenges related to enrollment and not due to efficacy or safety concerns, the sponsor terminated the study early and discontinued participant enrollment.",2.0,,Sponsor decision not related to efficacy or safety.,f,,,,t,t,f,,,,,,"When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.",Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf,https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,INDUSTRY,,,,,,,2023,0.0
NCT04182516,,2019-11-12,,,2024-09-05,2019-11-28,2019-12-02,ACTUAL,,,,,,,2024-09-05,2024-09-19,ACTUAL,2019-11-25,ACTUAL,2019-11-25,2024-09,2024-09-30,2024-05-16,ACTUAL,2024-05-16,2023-03-31,ACTUAL,2023-03-31,,INTERVENTIONAL,,,Study of NMS-03305293 in Pts with Selected Advanced/Metastatic Solid Tumors,A Phase I Dose Escalation Study of NMS-03305293 in Adult Patients with Selected Advanced/Metastatic Solid Tumors,TERMINATED,,PHASE1,52.0,ACTUAL,Nerviano Medical Sciences,,6.0,,The study closure is related to sponsor decision to shift towards the clinical development of NMS-03305293 in combination in a broader range of indication and not based on emerging safety or efficacy concerns.,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,INDUSTRY,,,,,,,2024,0.0
NCT04028713,,2019-07-19,,,2024-09-05,2019-07-22,2019-07-23,ACTUAL,,,,,,,2024-09-05,2024-09-19,ACTUAL,2021-02-16,ACTUAL,2021-02-16,2024-09,2024-09-30,2022-03-22,ACTUAL,2022-03-22,2022-03-22,ACTUAL,2022-03-22,,INTERVENTIONAL,,,Dose Tapering Study of Adalimumab in Psoriasis,A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients,TERMINATED,,PHASE4,19.0,ACTUAL,"University Hospital, Ghent",,2.0,,Too slow inclusion rate.,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,OTHER,,,,,,,2022,0.0
NCT04261439,,2020-02-06,,,2024-09-10,2020-02-06,2020-02-07,ACTUAL,,,,,,,2024-09-10,2024-09-19,ACTUAL,2020-02-27,ACTUAL,2020-02-27,2024-09,2024-09-30,2023-12-27,ACTUAL,2023-12-27,2023-12-27,ACTUAL,2023-12-27,,INTERVENTIONAL,,,A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab,A Phase I/Ib Study of Subcutaneous Recombinant Human NIZ985 ((hetIL-15) (IL-15/sIL-15Rα)) in Combination With Spartalizumab in Patients With Check Point Inhibitor (CPI) Relapsed Advanced Solid Tumors and Lymphoma,TERMINATED,,PHASE1,60.0,ACTUAL,Novartis,,2.0,,Sponsor's decision and not due to any safety concerns,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,INDUSTRY,,,,,,,2023,0.0
NCT05097079,,2021-10-18,,,2024-09-05,2021-10-18,2021-10-27,ACTUAL,,,,,,,2024-09-05,2024-09-19,ACTUAL,2021-11,ESTIMATED,2021-11-30,2024-09,2024-09-30,2023-05,ESTIMATED,2023-05-31,2023-05,ESTIMATED,2023-05-31,,INTERVENTIONAL,,,Efficacy and Safety Study of MYOBLOC in the Treatment of Sialorrhea in Pediatric Subjects,"A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® for the Treatment of Chronic Sialorrhea in Pediatric Subjects",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Supernus Pharmaceuticals, Inc.",,3.0,,Company/sponsor business decision,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,INDUSTRY,,,,,,,2023,0.0
NCT03884829,,2018-10-28,,,2024-09-11,2019-03-19,2019-03-21,ACTUAL,,,,,,,2024-09-11,2024-09-19,ACTUAL,2019-03-25,ACTUAL,2019-03-25,2024-09,2024-09-30,2023-10-19,ACTUAL,2023-10-19,2021-11-29,ACTUAL,2021-11-29,,INTERVENTIONAL,,,"A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS","A Phase I Pharmacologic Study of CYC140, a Polo-like Kinase 1 Inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes",TERMINATED,,PHASE1,7.0,ACTUAL,"Cyclacel Pharmaceuticals, Inc.",,1.0,,Switch to oral formulation of CYC140 (plogosertib),f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,INDUSTRY,,,,,,,2023,0.0
NCT05005182,,2021-08-09,2024-06-06,,2024-09-10,2021-08-12,2021-08-13,ACTUAL,2024-09-10,2024-09-19,ACTUAL,,,,2024-09-10,2024-09-19,ACTUAL,2023-02-20,ACTUAL,2023-02-20,2024-09,2024-09-30,2023-06-17,ACTUAL,2023-06-17,2023-04-17,ACTUAL,2023-04-17,,INTERVENTIONAL,,All patients have been combined in order to maintain patient privacy,Luspatercept With or Without Hydroxyurea for the Treatment of Myelodysplastic/Myeloproliferative Neoplasms With Ring Sideroblasts and Thrombocytosis or Unclassifiable With Ring Sideroblasts,"Phase II Study to Determine the Efficacy and Safety of Luspatercept (ACE-536) in Patients With Myelodysplastic/Myeloproliferative Neoplasms With Ring Sideroblasts and Thrombocytosis (MDS/MPN-RS-T) and Myelodysplastic/Myeloproliferative Neoplasms, Unclassifiable With Ring Sideroblasts (MDS/MPN-U With RS)",TERMINATED,,PHASE2,3.0,ACTUAL,Mayo Clinic,,2.0,,Slow accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,OTHER,,,,,,,2023,0.0
NCT06009653,,2023-08-19,,,2024-09-03,2023-08-19,2023-08-24,ACTUAL,,,,,,,2024-09-03,2024-09-19,ACTUAL,2023-09-13,ACTUAL,2023-09-13,2024-09,2024-09-30,2024-05-29,ACTUAL,2024-05-29,2024-05-29,ACTUAL,2024-05-29,,INTERVENTIONAL,TRZ,,Effects of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity,Effect of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity,TERMINATED,,PHASE4,32.0,ACTUAL,Washington University School of Medicine,,3.0,,Administrative Reasons,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,OTHER,,,,,,,2024,0.0
NCT04240210,,2020-01-06,,,2024-09-13,2020-01-22,2020-01-27,ACTUAL,,,,,,,2024-09-13,2024-09-19,ACTUAL,2019-09-17,ACTUAL,2019-09-17,2024-09,2024-09-30,2021-12-01,ACTUAL,2021-12-01,2021-12-01,ACTUAL,2021-12-01,,INTERVENTIONAL,SymITA,,Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita),SymITA: Switch to DRV/COB/FTC/TAF From Integrase Containing Regimens to Evaluate Changes in Tolerability/Adherence,TERMINATED,,PHASE4,1.0,ACTUAL,"Midland Research Group, Inc.",,2.0,,Lack of eligible enrollees/ Halted by Primary Sponsor,f,,,,f,t,f,,,t,,,,,,,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,OTHER,,,,,,,2021,0.0
NCT03772249,,2018-12-03,,,2024-09-11,2018-12-10,2018-12-11,ACTUAL,,,,,,,2024-09-11,2024-09-19,ACTUAL,2018-12-28,ACTUAL,2018-12-28,2024-09,2024-09-30,2022-07-12,ACTUAL,2022-07-12,2022-07-12,ACTUAL,2022-07-12,,INTERVENTIONAL,,,Study of Safety and Tolerability of DCR HBVS,"A Three-Part, Phase 1, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of DCR-HBVS in Healthy Volunteers and Patients With Chronic Hepatitis B",COMPLETED,,PHASE1,82.0,ACTUAL,Novo Nordisk A/S,,22.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,INDUSTRY,,,,,,,2022,1.0
NCT04876521,,2021-05-03,2023-06-03,,2024-09-09,2021-05-03,2021-05-06,ACTUAL,2024-09-09,2024-09-19,ACTUAL,,,,2024-09-09,2024-09-19,ACTUAL,2019-10-14,ACTUAL,2019-10-14,2024-09,2024-09-30,2021-06-30,ACTUAL,2021-06-30,2021-06-09,ACTUAL,2021-06-09,,INTERVENTIONAL,PSD-AOFC,,Low Dose Amisulpride Vs Olanzapine-Fluoxetine Combination in Post-Schizophrenic Depression,Comparative Efficacy and Safety of Low Dose Amisulpride Vs Olanzapine-Fluoxetine Combination in the Treatment of Post Schizophrenic Depression: A Randomized Controlled Trial,COMPLETED,,PHASE4,60.0,ACTUAL,"All India Institute of Medical Sciences, Bhubaneswar",1. Small sample size~2. Single-center study~3. No control arm for comparing the Serum BDNF levels,2.0,,,f,,,,f,f,f,,,,,,,,,NO,To maintain the confidentiality of the participants.,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,OTHER,,,,,,,2021,1.0
NCT04588246,,2020-10-07,,,2024-09-04,2020-10-13,2020-10-19,ACTUAL,,,,,,,2024-09-04,2024-09-19,ACTUAL,2020-12-15,ACTUAL,2020-12-15,2024-09,2024-09-30,2024-08-06,ACTUAL,2024-08-06,2024-08-06,ACTUAL,2024-08-06,,INTERVENTIONAL,,,Testing the Addition of Whole Brain Radiotherapy Using a Technique That Avoids the Hippocampus to Stereotactic Radiosurgery in People With Cancer That Has Spread to the Brain and Come Back in Other Areas of the Brain After Earlier Stereotactic Radiosurgery,Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS With Brain Metastasis Velocity &gt;/= 4 Brain Metastases/Year,TERMINATED,,PHASE3,19.0,ACTUAL,NRG Oncology,,2.0,,Accrual target will not be met.,f,,,,t,f,f,,,,,,,,,,,2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,OTHER,,,,,,,2024,0.0
NCT04458909,,2020-07-01,2024-08-23,,2024-08-23,2020-07-01,2020-07-07,ACTUAL,2024-08-23,2024-09-19,ACTUAL,,,,2024-08-23,2024-09-19,ACTUAL,2020-12-09,ACTUAL,2020-12-09,2024-08,2024-08-31,2023-08-15,ACTUAL,2023-08-15,2023-08-15,ACTUAL,2023-08-15,,INTERVENTIONAL,,Randomized participants,Testing the Addition of an Anti-cancer Immune Therapy Drug (Nivolumab) to the Usual Chemotherapy Treatment (Cisplatin or Carboplatin With Gemcitabine) for Recurrent or Metastatic Nasopharyngeal Cancer,"An Open-Label, Phase III Study of Platinum-Gemcitabine With or Without Nivolumab in the First-Line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma",TERMINATED,,PHASE3,15.0,ACTUAL,National Cancer Institute (NCI),"This study stopped accrual early at 15 participants of the 316 planned, due to published results of two other studies resolving the study question. As less than 5% of the sample size was accrued, no statistical testing was done.",2.0,,External information,f,,,,t,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.",2024-10-15 03:42:20.584897,2024-10-15 03:42:20.584897,NIH,,,,,,,2023,0.0
NCT04100083,,2019-09-20,,,2024-09-17,2019-09-20,2019-09-24,ACTUAL,,,,,,,2024-09-17,2024-09-19,ACTUAL,2020-09-21,ACTUAL,2020-09-21,2024-09,2024-09-30,2021-06-21,ACTUAL,2021-06-21,2021-06-21,ACTUAL,2021-06-21,,INTERVENTIONAL,,,Spironolactone for Hidradenitis Suppurativa,"Spironolactone in the Treatment of Hidradenitis Suppurativa: a Prospective, Open-Label Proof-of-Concept and Dose-Ranging Study",WITHDRAWN,,PHASE4,0.0,ACTUAL,Medical University of South Carolina,,3.0,,Lack of funding,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,OTHER,,,,,,,2021,0.0
NCT03365414,,2017-08-24,,,2024-09-11,2017-12-02,2017-12-07,ACTUAL,,,,,,,2024-09-11,2024-09-19,ACTUAL,2022-01,ESTIMATED,2022-01-31,2022-07,2022-07-31,2024-03,ESTIMATED,2024-03-31,2023-10,ESTIMATED,2023-10-31,,INTERVENTIONAL,,,A Study to Systematically Assess the Efficacy and Safety of Intravenous Albumin Infusions in Severe POTS,A Double Blind Randomized Controlled Crossover Study to Systematically Assess the Efficacy and Safety of Intravenous Albumin Infusions in Severe Postural Orthostatic Tachycardia Syndrome,WITHDRAWN,,PHASE3,0.0,ACTUAL,University of Alberta,,2.0,,Withdrawal of support of product for trial,f,,,,t,t,f,,,t,,,,,,NO,There is no plan to share individual participant data (IPD) available with other researchers.,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,OTHER,,,,,,,2024,0.0
NCT05635461,,2022-11-07,2024-03-11,,2024-08-23,2022-11-30,2022-12-02,ACTUAL,2024-03-11,2024-08-15,ACTUAL,,,,2024-08-23,2024-09-19,ACTUAL,2022-10-09,ACTUAL,2022-10-09,2024-08,2024-08-31,2022-11-21,ACTUAL,2022-11-21,2022-11-11,ACTUAL,2022-11-11,,INTERVENTIONAL,,Safety Analysis Set consisted of all participants who were enrolled and received study drug.,Relative Bioavailability and Food Effect Study of CVN424,"A Randomized, Open-Label, Single Oral Dose, Three-Way Cross-Over Trial to Evaluate the Relative Bioavailability of CVN424 Suspension &Tablet Formulations Including an Assessment of the Effect of Food on the Tablet Formulation in Healthy Adult Volunteers",COMPLETED,,PHASE1,32.0,ACTUAL,Cerevance,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,INDUSTRY,,,,,,,2022,1.0
NCT03453164,,2018-02-21,2021-08-25,,2024-04-16,2018-02-26,2018-03-05,ACTUAL,2024-04-16,2024-09-19,ACTUAL,,,,2024-04-16,2024-09-19,ACTUAL,2018-03-28,ACTUAL,2018-03-28,2024-04,2024-04-30,2021-01-31,ACTUAL,2021-01-31,2021-01-07,ACTUAL,2021-01-07,,INTERVENTIONAL,,"A total of 41 patients enrolled in this study were subjected to the safety analysis, and 40 patients, excluding one ineligible patient (72 years old, male), were subjected to the efficacy analysis.",Checkpoint Inhibitor and Radiotherapy for Recurrent Gastric Cancer (CIRCUIT),Combination of Checkpoint Inhibitor and Radiotherapy for Recurrent Gastric Cancer After Initial Treatment With Standard Therapy (CIRCUIT).,COMPLETED,,PHASE1/PHASE2,41.0,ACTUAL,Fukushima Medical University,,1.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,OTHER,,,,,,,2021,1.0
NCT02481830,,2015-06-23,2019-08-13,,2023-07-19,2015-06-23,2015-06-25,ESTIMATED,2020-01-06,2020-01-09,ACTUAL,,,,2023-07-19,2023-07-27,ACTUAL,2015-09-14,ACTUAL,2015-09-14,2023-07,2023-07-31,2022-08-30,ACTUAL,2022-08-30,2018-08-17,ACTUAL,2018-08-17,,INTERVENTIONAL,CheckMate331,All Randomized Participants,Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer,"An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First Line Chemotherapy (CheckMate 331: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 331)",COMPLETED,,PHASE3,569.0,ACTUAL,Bristol-Myers Squibb,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,INDUSTRY,,,,,,,2022,1.0
NCT05879185,,2023-05-18,,,2024-09-04,2023-05-18,2023-05-30,ACTUAL,,,,,,,2024-09-04,2024-09-19,ACTUAL,2023-04-06,ACTUAL,2023-04-06,2024-09,2024-09-30,2024-07-19,ACTUAL,2024-07-19,2024-07-19,ACTUAL,2024-07-19,,INTERVENTIONAL,,,A Study of XmAb23104 in People With Sarcoma,"Phase II Study of XmAb23104 (Targeting PD-1 and ICOS), in Patients With Advanced Sarcoma",TERMINATED,,PHASE2,6.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,Vendor decided study to be closed early,,,,,,t,f,,,,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,OTHER,,,,,,,2024,0.0
NCT03755934,,2018-10-31,2024-06-28,,2024-08-16,2018-11-26,2018-11-28,ACTUAL,2024-08-16,2024-09-19,ACTUAL,,,,2024-08-16,2024-09-19,ACTUAL,2018-11-19,ACTUAL,2018-11-19,2024-08,2024-08-31,2023-06-29,ACTUAL,2023-06-29,2023-06-29,ACTUAL,2023-06-29,,INTERVENTIONAL,,The Screening Population includes all participants who were enrolled and provided informed consent and demographic and/or baseline screening assessments.,Efficacy and Safety of MEDI7352 in Participants With Painful Diabetic Neuropathy,"A Randomised, Double-Blind, Placebo-Controlled, Dose-Response Study of the Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy",TERMINATED,,PHASE2,112.0,ACTUAL,AstraZeneca,Dose-response relationship outcome was not evaluated by MCP-MOD because of insufficient number of doses. The study was prematurely terminated due to longer enrolment time than was anticipated. A combined population PK analysis was reported separately from the main CSR as a stand-alone report.,4.0,,The study was prematurely terminated due to longer enrolment time than was anticipated.,f,,,,,t,f,,,t,,,,,,,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,INDUSTRY,,,,,,,2023,0.0
NCT03919773,,2019-02-05,2024-06-19,,2024-09-03,2019-04-14,2019-04-18,ACTUAL,2024-09-03,2024-09-19,ACTUAL,,,,2024-09-03,2024-09-19,ACTUAL,2018-10-29,ACTUAL,2018-10-29,2024-09,2024-09-30,2023-12-01,ACTUAL,2023-12-01,2023-06-26,ACTUAL,2023-06-26,,INTERVENTIONAL,iSTAND,,IVIG (Gamunex-C) Treatment Study for POTS Subjects,IVIG (Gamunex-C) Study of Treatment for Autoimmune Neuropathic Dysautonomia/Postural Tachycardia (POTS),COMPLETED,,PHASE1/PHASE2,30.0,ACTUAL,University of Texas Southwestern Medical Center,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,All patient information will be de-identified if sent out. Any AE and/or SAE will be sent out for review.,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,OTHER,,,,,,,2023,1.0
NCT04764448,,2021-01-27,,,2024-09-11,2021-02-17,2021-02-21,ACTUAL,,,,,,,2024-09-11,2024-09-19,ACTUAL,2021-02-12,ACTUAL,2021-02-12,2024-09,2024-09-30,2024-05-29,ACTUAL,2024-05-29,2023-12-08,ACTUAL,2023-12-08,,INTERVENTIONAL,ESTRELLA,,A Study of Belcesiran in Patients With AATLD,"A Phase 2, Randomized, Double-blind, Placebo-Controlled Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Dose Levels of Belcesiran in Patients With Alpha-1 Antitrypsin Deficiency-Associated Liver Disease",TERMINATED,,PHASE2,16.0,ACTUAL,Novo Nordisk A/S,,6.0,,Development project was discontinued,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,INDUSTRY,,,,,,,2024,0.0
NCT00499616,,2007-07-10,2015-12-01,,2021-07-01,2007-07-10,2007-07-11,ESTIMATED,2017-05-22,2017-06-27,ACTUAL,,,,2021-07-01,2021-07-06,ACTUAL,2007-10-08,ACTUAL,2007-10-08,2021-06,2021-06-30,2021-06-30,ACTUAL,2021-06-30,2014-06-30,ACTUAL,2014-06-30,,INTERVENTIONAL,,,Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma,Response- and Biology-Based Therapy for Intermediate-Risk Neuroblastoma,COMPLETED,,PHASE3,464.0,ACTUAL,Children's Oncology Group,,4.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,NETWORK,,,,,,,2021,1.0
NCT04877080,,2021-04-13,,,2023-02-08,2021-05-05,2021-05-07,ACTUAL,,,,,,,2023-02-08,2023-02-10,ACTUAL,2021-05-05,ESTIMATED,2021-05-05,2023-02,2023-02-28,2023-12-31,ESTIMATED,2023-12-31,2023-06-30,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,CD19 and BCMA Targeted Fast Dual CAR-T for CD19+ Refractory/Relapsed B-NHL,Exploratory Study to Evaluate Efficacy and Safety of Fast Dual CAR-T Injection in CD19+ Refractory or Relapsed B Cell Non-Hodgkinlymphoma,WITHDRAWN,,PHASE1,0.0,ACTUAL,920th Hospital of Joint Logistics Support Force of People's Liberation Army of China,,1.0,,The PI decides to withdraw the research.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,OTHER,,,,,,,2023,0.0
NCT05121766,,2021-11-15,2024-04-18,,2024-09-13,2021-11-15,2021-11-16,ACTUAL,2024-09-13,2024-09-19,ACTUAL,,,,2024-09-13,2024-09-19,ACTUAL,2022-01-10,ACTUAL,2022-01-10,2024-09,2024-09-30,2023-04-21,ACTUAL,2023-04-21,2023-04-21,ACTUAL,2023-04-21,,INTERVENTIONAL,,Patients consented into the study,Feasibility Pilot Clinical Trial of Omega-3 Supplement vs. Placebo for Post Covid-19 Recovery Among Health Care Workers,Feasibility Pilot Clinical Trial of Omega-3 (EPA+DHA) Supplement vs. Placebo for Post-Acute Sequelae of Coronavirus-19 (COVID-19) Recovery Among Health Care Workers,TERMINATED,,PHASE1,32.0,ACTUAL,Hackensack Meridian Health,,2.0,,Challenges in enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,OTHER,,,,,,,2023,0.0
NCT04439539,,2020-06-18,2024-08-27,,2024-08-27,2020-06-18,2020-06-19,ACTUAL,2024-08-27,2024-09-19,ACTUAL,,,,2024-08-27,2024-09-19,ACTUAL,2020-09-14,ACTUAL,2020-09-14,2024-08,2024-08-31,2024-02-13,ACTUAL,2024-02-13,2023-08-29,ACTUAL,2023-08-29,,INTERVENTIONAL,,,"A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection","A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate Efficacy, Pharmacokinetics, Safety, and Tolerability of Treatment With JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog With or Without JNJ-56136379 in Treatment-naive Patients With HBeAg Positive Chronic Hepatitis B Virus Infection",COMPLETED,,PHASE2,54.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu",2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,INDUSTRY,,,,,,,2024,1.0
NCT03524612,,2018-05-02,2023-10-02,2022-09-22,2024-09-16,2018-05-02,2018-05-15,ACTUAL,2023-12-05,2023-12-27,ACTUAL,,2023-12-27,ACTUAL,2024-09-16,2024-09-19,ACTUAL,2018-11-02,ACTUAL,2018-11-02,2024-09,2024-09-30,2022-10-03,ACTUAL,2022-10-03,2021-10-22,ACTUAL,2021-10-22,,INTERVENTIONAL,TAPER,,A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP,"A Phase II, Open-label, Prospective, Single-arm, Study to Assess Ability of Eltrombopag to Induce Sustained Remission in Subjects With ITP Who Are Refractory or Relapsed After First-line Steroids",COMPLETED,,PHASE2,105.0,ACTUAL,Novartis,,1.0,,,f,,,,f,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,INDUSTRY,,,,,,,2022,1.0
NCT03955146,,2019-05-16,2024-08-22,2024-03-15,2024-09-16,2019-05-16,2019-05-17,ACTUAL,2024-09-16,2024-09-19,ACTUAL,,2023-12-15,ACTUAL,2024-09-16,2024-09-19,ACTUAL,2019-06-18,ACTUAL,2019-06-18,2024-09,2024-09-30,2023-08-28,ACTUAL,2023-08-28,2023-03-20,ACTUAL,2023-03-20,,INTERVENTIONAL,,The intent-to-treat (ITT) population included all randomized participants.,Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF),"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)",TERMINATED,,PHASE3,393.0,ACTUAL,FibroGen,"Study did not meet its primary endpoint; hence, it was terminated early. The Japan extension cohort and OLE period were halted due to futility.",6.0,,Study did not meet its primary endpoint.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,INDUSTRY,,,,,,,2023,0.0
NCT04965818,,2021-07-06,,,2024-09-06,2021-07-14,2021-07-16,ACTUAL,,,,,,,2024-09-06,2024-09-19,ACTUAL,2021-09-20,ACTUAL,2021-09-20,2024-09,2024-09-30,2023-09-21,ACTUAL,2023-09-21,2023-06-11,ACTUAL,2023-06-11,,INTERVENTIONAL,,,Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer,"A Phase 1b/2 Open-label, Nonrandomized Study of FGFR Inhibitor Futibatinib in Combination With MEK-inhibitor Binimetinib in Patients With Advanced KRAS Mutant Cancer",TERMINATED,,PHASE1,38.0,ACTUAL,"Taiho Oncology, Inc.",,1.0,,Strategic decision by sponsor.,f,,,,,t,f,,,,,,,,,,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,INDUSTRY,,,,,,,2023,0.0
NCT02728102,,2016-03-30,2021-07-09,,2024-05-03,2016-03-30,2016-04-05,ESTIMATED,2021-09-07,2021-09-09,ACTUAL,,,,2024-05-03,2024-05-07,ACTUAL,2016-07,ACTUAL,2016-07-31,2024-05,2024-05-31,2022-12-09,ACTUAL,2022-12-09,2020-06-30,ACTUAL,2020-06-30,,INTERVENTIONAL,,,Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401),Phase II Multicenter Trial of Single Autologous Hematopoietic Cell Transplant Followed by Lenalidomide Maintenance for Multiple Myeloma With or Without Vaccination With Dendritic Cell/Myeloma Fusions (BMT CTN 1401),COMPLETED,,PHASE2,203.0,ACTUAL,"National Heart, Lung, and Blood Institute (NHLBI)",,3.0,,,f,,,,t,,,,,,,,Within 6 months of official study closure at participating sites.,Available to the public,https://biolincc.nhlbi.nih.gov/home/,YES,"Results will be published in a manuscript and supporting information submitted to NIH BioLINCC (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc where indicated).",2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,NIH,,,,,,,2022,1.0
NCT04176653,,2019-11-07,,,2020-04-23,2019-11-21,2019-11-25,ACTUAL,,,,,,,2020-04-23,2020-04-27,ACTUAL,2019-08-20,ACTUAL,2019-08-20,2020-04,2020-04-30,2021-10-14,ESTIMATED,2021-10-14,2021-09-30,ESTIMATED,2021-09-30,,INTERVENTIONAL,,,Study in Beta-thalassaemia or Myelodysplastic Syndrome Patients to Investigate the Safety and Tolerability of SLN124,"Phase 1b Single Ascending and Multiple Dose First-in-man Study in Adult Patients With Non-transfusion-dependent Beta-thalassaemia or Low Risk Myelodysplastic Syndrome to Investigate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of SLN124",WITHDRAWN,,PHASE1,0.0,ACTUAL,Silence Therapeutics plc,,5.0,,"Study stopped prior to subject administered first dose, due to COVID-19",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,INDUSTRY,,,,,,,2021,0.0
NCT03338660,,2017-02-01,,,2019-05-24,2017-11-08,2017-11-09,ACTUAL,,,,,,,2019-05-24,2019-05-29,ACTUAL,2018-07-15,ESTIMATED,2018-07-15,2019-05,2019-05-31,2020-07-15,ESTIMATED,2020-07-15,2019-07-15,ESTIMATED,2019-07-15,,INTERVENTIONAL,,,Platelet Function With Various Storage Techniques,The Impact of Various Storage Techniques on Platelet Function,WITHDRAWN,,PHASE2,0.0,ACTUAL,Northwell Health,,3.0,,Unable to begin study due to funding. PI has left organization.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,OTHER,,,,,,,2020,0.0
NCT05253209,,2022-01-24,,,2024-09-13,2022-02-21,2022-02-23,ACTUAL,,,,,,,2024-09-13,2024-09-19,ACTUAL,2022-06-29,ACTUAL,2022-06-29,2023-08,2023-08-31,2024-05-10,ACTUAL,2024-05-10,2024-05-10,ACTUAL,2024-05-10,,INTERVENTIONAL,,,A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects,"A Phase III Double-Blind, Randomized, Placebo Controlled, Multi Center Clinical Study to Evaluate the Efficacy and Safety of Intravenous L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects",TERMINATED,,PHASE3,64.0,ACTUAL,"Asklepion Pharmaceuticals, LLC",,2.0,,Interim Analysis triggered futility,f,,,,t,t,f,,,f,,,,,,UNDECIDED,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,INDUSTRY,,,,,,,2024,0.0
NCT05094206,,2021-10-17,,,2024-09-10,2021-10-17,2021-10-26,ACTUAL,,,,,,,2024-09-10,2024-09-19,ACTUAL,2022-06-30,ACTUAL,2022-06-30,2024-09,2024-09-30,2024-01-29,ACTUAL,2024-01-29,2024-01-29,ACTUAL,2024-01-29,,INTERVENTIONAL,,,"CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies","Phase I Trial of Anti-CD20, Anti-CD19, Anti-CD22 CAR (CAR20.19.22) T-cells for Relapsed, Refractory B-cell Malignancies",TERMINATED,,PHASE1,4.0,ACTUAL,Medical College of Wisconsin,,10.0,,Treated four patients: 2 at a dose of 1x10\^6 cells/kg and 2 ad at dose of 2.5x10\^6 cells/kg. All four patients had no in-vivo expansion and no meaningful response to therapy. At this point per FDA guidance we will not be treating more patients.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,OTHER,,,,,,,2024,0.0
NCT04475198,,2020-07-09,2023-06-16,,2023-07-17,2020-07-16,2020-07-17,ACTUAL,2023-07-17,2023-08-03,ACTUAL,,,,2023-07-17,2023-08-03,ACTUAL,2021-03-04,ACTUAL,2021-03-04,2023-07,2023-07-31,2021-08-18,ACTUAL,2021-08-18,2021-08-18,ACTUAL,2021-08-18,,INTERVENTIONAL,,,"Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ST-2427","A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ST-2427 IV Infusion in Healthy Subjects",TERMINATED,,PHASE1,24.0,ACTUAL,"SiteOne Therapeutics, Inc.",,5.0,,strategic decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,INDUSTRY,,,,,,,2021,0.0
NCT06424236,,2024-04-16,,2024-08-14,2024-08-30,2024-05-15,2024-05-22,ACTUAL,,,,,2024-07-03,ACTUAL,2024-08-30,2024-09-19,ACTUAL,2020-06-30,ACTUAL,2020-06-30,2024-08,2024-08-31,2023-11-13,ACTUAL,2023-11-13,2023-10-06,ACTUAL,2023-10-06,,INTERVENTIONAL,DIAN-TU,,Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia: A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation,"A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker, Cognitive, and Clinical Endpoints in Dominantly Inherited Alzheimer's Disease",TERMINATED,,PHASE2/PHASE3,73.0,ACTUAL,Washington University School of Medicine,,1.0,,DIAN-TU announced the discontinuation of the DIAN-TU-001 OLE based on findings from an interim efficacy analysis and the status of the drug program.,f,,,,t,t,f,,,,,,,,,YES,"Access to DIAN-TU trial data will follow the DIAN-TU data access policy, which complies with the guidelines established by the Collaboration for Alzheimer's Prevention \[CAP REF\].",2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,OTHER,,,,,,,2023,0.0
NCT02002598,,2013-12-02,2024-05-13,,2024-08-20,2013-12-05,2013-12-06,ESTIMATED,2024-08-20,2024-09-19,ACTUAL,,,,2024-08-20,2024-09-19,ACTUAL,2013-11,,2013-11-30,2024-08,2024-08-31,2023-07-01,ACTUAL,2023-07-01,2019-03-01,ACTUAL,2019-03-01,,INTERVENTIONAL,,"Data was collected and analyzed as one arm for this single-arm study. Additionally, presented as one arm to protect the confidentiality of the first four participants.",Carfilzomib With Bendamustine and Dexamethasone in Multiple Myeloma,Phase I/II Study of Carfilzomib in Combination With Bendamustine and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma,TERMINATED,,PHASE1/PHASE2,23.0,ACTUAL,Columbia University,"The limitations of this study include a small sample size, failure to complete planned accrual, and lack of high cytogenetic risk patients.",1.0,,Slow accrual and loss of funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,OTHER,,,,,,,2023,0.0
NCT05088460,,2021-10-12,,,2024-09-11,2021-10-12,2021-10-22,ACTUAL,,,,,,,2024-09-11,2024-09-19,ACTUAL,2022-02-28,ACTUAL,2022-02-28,2024-09,2024-09-30,2024-04-18,ACTUAL,2024-04-18,2023-12-13,ACTUAL,2023-12-13,,INTERVENTIONAL,LEAP,,A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD),A Randomized Double-Blind Placebo-Controlled Study of the LEPR Agonist Antibody REGN4461 for the Treatment of Metabolic Abnormalities in Patients With Familial Partial Lipodystrophy,TERMINATED,,PHASE2,20.0,ACTUAL,Regeneron Pharmaceuticals,,2.0,,Sponsor Decision,t,,,,,t,f,,,,,,"Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification","Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).",https://vivli.org/,YES,All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,INDUSTRY,,NCT04710056,AVAILABLE,,,,2024,0.0
NCT05655598,,2022-12-09,,,2024-09-09,2022-12-16,2022-12-19,ACTUAL,,,,,,,2024-09-09,2024-09-19,ACTUAL,2023-09-12,ACTUAL,2023-09-12,2024-09,2024-09-30,2024-08-05,ACTUAL,2024-08-05,2024-08-05,ACTUAL,2024-08-05,,INTERVENTIONAL,,,TAS-116 Plus Palbociclib in Breast and Rb-null Cancer,Phase Ib IIT of Heat Shock Protein 90 Inhibitor TAS-116 Combined with Cyclin-dependent Kinase 4/6 Inhibitor Palbociclib in Advanced Breast Cancer Progressing on Palbociclib & Treatment-refractory Solid Tumors with Retinoblastoma Deficiency,WITHDRAWN,,PHASE1,0.0,ACTUAL,Brown University,,3.0,,Lack of accrual,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,OTHER,,,,,,,2024,0.0
NCT00274937,,2006-01-10,2016-10-24,,2022-10-03,2006-01-10,2006-01-11,ESTIMATED,2016-11-23,2017-01-19,ESTIMATED,,,,2022-10-03,2022-10-25,ACTUAL,2006-02-20,ACTUAL,2006-02-20,2022-10,2022-10-31,2022-09-30,ACTUAL,2022-09-30,2014-12-31,ACTUAL,2014-12-31,,INTERVENTIONAL,,,"Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer",Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study,COMPLETED,,PHASE3,111.0,ACTUAL,Children's Oncology Group,Data was and never will never be collected for Outcome Measure #2 and Outcome Measure #3. Funding was not obtained and results will never be reported for Outcome Measure #4.,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,NETWORK,,,,,,,2022,1.0
NCT03279081,,2017-07-21,2024-07-12,2024-01-11,2024-08-22,2017-09-08,2017-09-12,ACTUAL,2024-08-22,2024-09-19,ACTUAL,,2024-09-19,ACTUAL,2024-08-22,2024-09-19,ACTUAL,2017-09-15,ACTUAL,2017-09-15,2024-08,2024-08-31,2023-07-26,ACTUAL,2023-07-26,2023-01-23,ACTUAL,2023-01-23,,INTERVENTIONAL,ADMIRE-CD-II,The Intent-to-treat (ITT) Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not.,"Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)","A Phase-III, Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease Over a Period of 24 Weeks and a Follow-up Period up to 52 Weeks",COMPLETED,,PHASE3,568.0,ACTUAL,Takeda,,2.0,,,f,,,,f,t,f,,,,,,,"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.",https://vivli.org/ourmember/takeda/,YES,"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.",2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,INDUSTRY,,,,,,,2023,1.0
NCT00072462,,2003-11-04,2022-10-07,,2024-04-12,2003-11-05,2003-11-06,ESTIMATED,2024-04-12,2024-09-19,ACTUAL,,,,2024-04-12,2024-09-19,ACTUAL,2003-09,,2003-09-30,2024-04,2024-04-30,2021-05-31,ACTUAL,2021-05-31,2015-12,ACTUAL,2015-12-31,,INTERVENTIONAL,IBIS-II DCIS,,Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ,International Breast Cancer Intervention Study II (IBIS-II) (DCIS),COMPLETED,,PHASE3,2980.0,ACTUAL,Queen Mary University of London,"This CTIMP trial, which recruited between 03 Mar 2003 and 08 Feb 2012, formally ended on 31 May 2021.",2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,OTHER,,,,,,,2021,1.0
NCT04531176,,2020-08-10,2024-02-06,,2024-08-27,2020-08-27,2020-08-28,ACTUAL,2024-07-19,2024-07-22,ACTUAL,,,,2024-08-27,2024-09-19,ACTUAL,2020-09-01,ACTUAL,2020-09-01,2024-08,2024-08-31,2023-08-04,ACTUAL,2023-08-04,2022-08-15,ACTUAL,2022-08-15,,INTERVENTIONAL,EMPOWER-T2D,Individual participants who were randomized to each arm of the study,EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial,An ObEsity-centric Approach With and Without Anti-obesity Medications ComPared to the Usual-care ApprOach to Management of Patients With Obesity and Type 2 Diabetes in an Employer Setting: A Pragmatic Randomized Controlled Trial,TERMINATED,,PHASE4,74.0,ACTUAL,The Cleveland Clinic,,3.0,,"After an unplanned yet IRB approved interim analysis, it was found that there was not a significant difference between the 3 arms of the study. The study was closed due to futility. All Patients are off study and this study will not resume.",f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,OTHER,,,,,,,2023,0.0
NCT05027594,,2021-08-25,,,2024-09-10,2021-08-25,2021-08-30,ACTUAL,,,,,,,2024-09-10,2024-09-19,ACTUAL,2022-09-09,ACTUAL,2022-09-09,2024-09,2024-09-30,2024-01-08,ACTUAL,2024-01-08,2023-08-08,ACTUAL,2023-08-08,,INTERVENTIONAL,,,Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma,"A Phase I Dose Escalation Study of NMS-03597812, a PERK Inhibitor, in Adult Patients With Relapsed or Refractory Multiple Myeloma",TERMINATED,,PHASE1,5.0,ACTUAL,Nerviano Medical Sciences,,3.0,,The decision is not based on emerging safety or efficacy concerns but on strategic reasons related to the changing and competitive treatment options in Multiple Myeloma,f,,,,f,t,f,,,,,,,,,,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,INDUSTRY,,,,,,,2024,0.0
NCT04922424,,2021-06-04,,,2022-10-31,2021-06-04,2021-06-10,ACTUAL,,,,,,,2022-10-31,2022-11-03,ACTUAL,2022-09-30,ESTIMATED,2022-09-30,2022-10,2022-10-31,2023-08-31,ESTIMATED,2023-08-31,2023-08-31,ESTIMATED,2023-08-31,,INTERVENTIONAL,,,Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men,Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men,WITHDRAWN,,PHASE1,0.0,ACTUAL,Yale University,,2.0,,not funded,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,OTHER,,,,,,,2023,0.0
NCT05356897,,2022-04-27,,,2024-09-17,2022-04-27,2022-05-02,ACTUAL,,,,,,,2024-09-17,2024-09-19,ACTUAL,2023-10-31,ACTUAL,2023-10-31,2024-09,2024-09-30,2024-09-17,ACTUAL,2024-09-17,2024-09-17,ACTUAL,2024-09-17,,INTERVENTIONAL,,,"Tucatinib Combined with Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study",3T: a Phase II Single Arm Open Label Study of Tucatinib Combined with Trastuzumab and TAS-102 in Molecularly Selected Patients with HER2+ Metastatic Colorectal Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,Academic and Community Cancer Research United,,1.0,,no sites were regulatory ready and the SC took the study to a different group.,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,OTHER,,,,,,,2024,0.0
NCT05679388,,2022-12-23,,,2024-09-06,2022-12-23,2023-01-11,ACTUAL,,,,,,,2024-09-06,2024-09-19,ACTUAL,2023-02-13,ACTUAL,2023-02-13,2023-10,2023-10-31,2024-08-05,ACTUAL,2024-08-05,2024-08-05,ACTUAL,2024-08-05,,INTERVENTIONAL,,,A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients,A Phase Ib Study of Extending Relugolix Dosing Intervals Through Addition of the CYP3A4 and Pg-P Inhibitor Itraconazole or Ritonavir in Prostate Cancer Patients,TERMINATED,,PHASE1,60.0,ACTUAL,University of Chicago,,5.0,,Terminated by the PI,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,OTHER,,,,,,,2024,0.0
NCT03199976,,2017-06-26,2022-12-20,,2024-05-13,2017-06-26,2017-06-27,ACTUAL,2024-05-13,2024-09-19,ACTUAL,,,,2024-05-13,2024-09-19,ACTUAL,2016-04-20,ACTUAL,2016-04-20,2024-05,2024-05-31,2020-11-18,ACTUAL,2020-11-18,2020-11-18,ACTUAL,2020-11-18,,INTERVENTIONAL,,,Efficacy of Intermittent Tiotropium in Early Childhood Wheezing,Efficacy of Intermittent Tiotropium in Early Childhood Wheezing,TERMINATED,,PHASE4,80.0,ACTUAL,Helsinki University Central Hospital,Early termination leading to small numbers of subjects analyzed.,3.0,,Subjects in the Salbutamol group discontinued the intervention more often due to troublesome respiratory symptoms,f,,,,t,f,f,,,,,,,,,NO,Deidentified individual participant data will not be made available.,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,OTHER,,,,,,,2020,0.0
NCT03666728,,2018-09-10,,,2021-03-15,2018-09-10,2018-09-12,ACTUAL,,,,,,,2021-03-15,2021-03-17,ACTUAL,2018-11-30,ACTUAL,2018-11-30,2021-03,2021-03-31,2020-03-11,ACTUAL,2020-03-11,2020-03-11,ACTUAL,2020-03-11,,INTERVENTIONAL,,,A Study of SHR-1210 in Combination With BP102 in Subjects With Non-squamous NSCLC,"An Open-label, Single-arm, Multi-center, Phase 2 Study to Evaluate SHR-1210 Combination With BP102 in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Whose PD-L1 Positive and EGFR/ALK Wild Type.",TERMINATED,,PHASE2,5.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,1.0,,changes in the R\&D strategy,f,,,,,f,f,,,,,,,,,,,2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,INDUSTRY,,,,,,,2020,0.0
NCT05194839,,2022-01-04,2023-06-07,,2023-06-28,2022-01-04,2022-01-18,ACTUAL,2023-06-28,2023-06-29,ACTUAL,,,,2023-06-28,2023-06-29,ACTUAL,2022-01-05,ACTUAL,2022-01-05,2023-06,2023-06-30,2023-03-06,ACTUAL,2023-03-06,2023-02-13,ACTUAL,2023-02-13,,INTERVENTIONAL,,,A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP),"A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Palmoplantar Pustulosis",TERMINATED,,PHASE2,79.0,ACTUAL,"Aristea Therapeutics, Inc.",,3.0,,Due to safety findings in ongoing Phase 2 trials.,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,INDUSTRY,,,,,,,2023,0.0
NCT01772472,,2013-01-17,2019-07-24,,2024-09-13,2013-01-17,2013-01-21,ESTIMATED,2019-09-09,2019-10-01,ACTUAL,,,,2024-09-13,2024-09-19,ACTUAL,2013-04-03,ACTUAL,2013-04-03,2024-09,2024-09-30,2024-05-23,ACTUAL,2024-05-23,2018-07-25,ACTUAL,2018-07-25,,INTERVENTIONAL,,The intent-to-treat (ITT) population was defined as all participants enrolled in the study regardless of whether or not they received any study drug.,A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE),"A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy",COMPLETED,,PHASE3,1487.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 03:48:22.381138,2024-10-15 03:48:22.381138,INDUSTRY,,,,,,,2024,1.0
NCT05430854,,2022-06-20,2024-08-14,,2024-09-05,2022-06-20,2022-06-24,ACTUAL,2024-09-05,2024-09-19,ACTUAL,,,,2024-09-05,2024-09-19,ACTUAL,2022-06-01,ACTUAL,2022-06-01,2024-08,2024-08-31,2023-10-31,ACTUAL,2023-10-31,2023-10-31,ACTUAL,2023-10-31,,INTERVENTIONAL,RECAST SLE OLE,OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study.,Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study,An Open-Label Extension Study To Evaluate The Long- Term Safety And Tolerability Of Daxdilimab (Hzn-7734) In Subjects With Systemic Lupus Erythematosus,TERMINATED,,PHASE2,155.0,ACTUAL,Amgen,,1.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2023,0.0
NCT03382925,,2017-12-04,2020-08-19,,2022-11-22,2017-12-18,2017-12-26,ACTUAL,2021-04-26,2021-05-18,ACTUAL,,,,2022-11-22,2022-11-25,ACTUAL,2017-12-20,ACTUAL,2017-12-20,2022-11,2022-11-30,2020-08-19,ACTUAL,2020-08-19,2019-08-19,ACTUAL,2019-08-19,,INTERVENTIONAL,,,Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?,Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized,TERMINATED,,PHASE4,16.0,ACTUAL,University of Utah,Early termination leading to low enrollment which ended up being the greatest limitation.,2.0,,Not enough cervical interlaminar patients who meet criteria in order to meet recruitment goals.,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,OTHER,,,,,,,2020,0.0
NCT03818256,,2019-01-24,2024-05-22,,2024-09-12,2019-01-24,2019-01-28,ACTUAL,2024-09-12,2024-09-19,ACTUAL,,,,2024-09-12,2024-09-19,ACTUAL,2019-12-04,ACTUAL,2019-12-04,2024-09,2024-09-30,2022-07-06,ACTUAL,2022-07-06,2022-06-17,ACTUAL,2022-06-17,,INTERVENTIONAL,GRATITUDE,All enrolled patients,"A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adult Patients With Schizophrenia or Bipolar Disorder and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)",COMPLETED,,PHASE2,71.0,ACTUAL,Corcept Therapeutics,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2022,1.0
NCT03796650,,2019-01-04,,,2024-09-09,2019-01-07,2019-01-08,ACTUAL,,,,,,,2024-09-09,2024-09-19,ACTUAL,2019-07-17,ACTUAL,2019-07-17,2024-09,2024-09-30,2024-04-02,ACTUAL,2024-04-02,2024-04-02,ACTUAL,2024-04-02,,INTERVENTIONAL,COLONIZE,,Fecal Transplantation for Primary Clostridium Difficile Infection,COmparative Effectiveness of IntestinaL MicrobiOta Versus VaNcomycin for Primary C. Difficile Infection - RandomiZEd Trials,TERMINATED,,PHASE3,104.0,ACTUAL,Oslo University Hospital,,2.0,,Pre-specified non-inferiority criterion met at interim analysis.,f,,,,t,f,f,,,f,,,,,,UNDECIDED,The trial adheres to data sharing policies of the ICMJE. Data sharing is considered for each request by the principal investigators. Data sharing is not granted if they overlap with planned analyses. Data sharing requires all approvals by relevant authorities. Costs for data sharing will not be covered by the study group.,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,OTHER,,,,,,,2024,0.0
NCT04952597,,2021-06-28,2024-07-16,,2024-08-16,2021-06-28,2021-07-07,ACTUAL,2024-08-16,2024-09-19,ACTUAL,,,,2024-08-16,2024-09-19,ACTUAL,2021-07-15,ACTUAL,2021-07-15,2024-08,2024-08-31,2023-07-26,ACTUAL,2023-07-26,2023-07-26,ACTUAL,2023-07-26,,INTERVENTIONAL,,The Intent-To-Treat (ITT) Analysis Set includes all randomized patients.,Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer,"A Phase 2, Multicenter, Randomized, 3-Arm, Open-Label Study to Investigate the Preliminary Efficacy and Safety of the Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Plus Tislelizumab Plus Concurrent Chemoradiotherapy in Patients With Untreated Limited-Stage Small Cell Lung Cancer",COMPLETED,,PHASE2,126.0,ACTUAL,BeiGene,,3.0,,,f,,,,,t,f,,,,,,,,,YES,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2023,1.0
NCT04109547,,2019-09-27,2022-09-21,,2024-09-06,2019-09-27,2019-09-30,ACTUAL,2023-09-04,2023-09-14,ACTUAL,,,,2024-09-06,2024-09-19,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2024-09,2024-09-30,2021-10-27,ACTUAL,2021-10-27,2021-09-23,ACTUAL,2021-09-23,,INTERVENTIONAL,PIONEER 11,Full analysis set included all randomized participants.,A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes,China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only,COMPLETED,,PHASE3,521.0,ACTUAL,Novo Nordisk A/S,,4.0,,,f,,,,f,f,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2021,1.0
NCT04780061,,2021-03-01,2023-02-06,,2024-09-11,2021-03-01,2021-03-03,ACTUAL,2024-09-11,2024-09-19,ACTUAL,,,,2024-09-11,2024-09-19,ACTUAL,2021-07-12,ACTUAL,2021-07-12,2024-09,2024-09-30,2022-07-07,ACTUAL,2022-07-07,2022-05-03,ACTUAL,2022-05-03,,INTERVENTIONAL,,Participants only included if they began study treatments.,Dietary Supplements for COVID-19,"Dietary Supplements to Reduce Symptom Severity and Duration in People With SARS-CoV-2: A Randomized, Double Blind, Placebo Controlled Clinical Trial",TERMINATED,,PHASE3,90.0,ACTUAL,The Canadian College of Naturopathic Medicine,Early termination leading to small number of subjects analyzed; Symptom severity and duration questionnaire not validated,2.0,,Public PCR testing stopped in Ontario,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,OTHER,,,,,,,2022,0.0
NCT04315948,,2020-03-13,,,2024-09-10,2020-03-18,2020-03-20,ACTUAL,,,,,,,2024-09-10,2024-09-19,ACTUAL,2020-03-22,ACTUAL,2020-03-22,2024-09,2024-09-30,2023-09-25,ACTUAL,2023-09-25,2022-07-09,ACTUAL,2022-07-09,,INTERVENTIONAL,DisCoVeRy,,Trial of Treatments for COVID-19 in Hospitalized Adults,"Multi-centre, Adaptive, Randomized Trial of the Safety and Efficacy of Treatments of COVID-19 in Hospitalized Adults",COMPLETED,,PHASE3,1552.0,ACTUAL,"Institut National de la Santé Et de la Recherche Médicale, France",,7.0,,,f,,,,t,f,f,,,,,,Study protocol and statistical analysis plan will be available from September 2020 with no time limit.~Other data will be available upon request after first publication of the results for at least 5 years,Study protocol and statistical analysis plan will be published. All requests for the trial's data will be considered by the French DisCoVeRy Trial Management Team that can be contacted via the principal investigator: florence.ader@chu-lyon.fr,,YES,"Study protocol and statistical analysis plan will be available. Systematic individual patient data sharing is not intended, but all requests for the trial's data will be considered by the French DisCoVeRy Trial Management Team.",2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,OTHER_GOV,,,,,,,2023,1.0
NCT03733990,,2018-10-23,,,2023-11-23,2018-11-05,2018-11-07,ACTUAL,,,,,,,2023-11-23,2023-11-27,ACTUAL,2018-12-03,ACTUAL,2018-12-03,2023-11,2023-11-30,2023-10-31,ACTUAL,2023-10-31,2023-09-06,ACTUAL,2023-09-06,,INTERVENTIONAL,,,"A Study to Evaluate Safety, Tolerability and Preliminary Efficacy of FP-1305 in Cancer Patients (MATINS)","A Phase I/II Open-Label, Three-Part, Dose-Finding and Separate Cohort Expansion Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Repeated Doses of CLEVER-1 Antibody FP-1305, in Subjects With Advanced Solid Tumours",COMPLETED,,PHASE1/PHASE2,216.0,ACTUAL,Faron Pharmaceuticals Ltd,,6.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:40:32.340931,2024-10-15 06:40:32.340931,INDUSTRY,,,,,,,2023,0.0
NCT03878719,,2019-02-20,,,2023-03-29,2019-03-15,2019-03-18,ACTUAL,,,,,,,2023-03-29,2023-04-03,ACTUAL,2020-08-03,ACTUAL,2020-08-03,2023-03,2023-03-31,2022-08-19,ACTUAL,2022-08-19,2022-08-19,ACTUAL,2022-08-19,,INTERVENTIONAL,,,Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma,"A Multicenter, Open-label Phase 1b Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma",TERMINATED,,PHASE1,1.0,ACTUAL,Pfizer,,2.0,,The trial was terminated early on 05 October 2022 due to non-feasibility and poor recruitment and not based on safety concerns.,f,,,,t,t,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,INDUSTRY,,,,,,,2022,0.0
NCT05343754,,2022-04-11,,,2024-09-17,2022-04-18,2022-04-25,ACTUAL,,,,,,,2024-09-17,2024-09-19,ACTUAL,2022-06-01,ACTUAL,2022-06-01,2022-07,2022-07-31,2024-01-14,ACTUAL,2024-01-14,2024-01-14,ACTUAL,2024-01-14,,INTERVENTIONAL,HOTPANTS,,Hyperbaric Oxygen Therapy for Pyoderma Gangrenosum,Hyperbaric Oxygen Therapy for Pyoderma Gangrenosum As a New Treatment Strategy,TERMINATED,,PHASE3,3.0,ACTUAL,Erasmus Medical Center,,2.0,,Due to low recruitment,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,OTHER,,,,,,,2024,0.0
NCT04576988,,2020-09-28,2023-07-18,,2024-09-17,2020-10-01,2020-10-06,ACTUAL,2023-08-21,2023-08-23,ACTUAL,,,,2024-09-17,2024-09-19,ACTUAL,2021-01-25,ACTUAL,2021-01-25,2024-09,2024-09-30,2022-12-06,ACTUAL,2022-12-06,2022-08-26,ACTUAL,2022-08-26,,INTERVENTIONAL,,"Of the 324 participants randomized in the study, one participant was randomized in error in placebo plus background PAH therapy arm and no data was collected on this participant. Per protocol, this participant was excluded from the study analysis.",A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR),"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH",COMPLETED,,PHASE3,324.0,ACTUAL,"Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA",,2.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2022,1.0
NCT03827044,,2018-07-26,,,2022-10-05,2019-01-30,2019-02-01,ACTUAL,,,,,,,2022-10-05,2022-10-07,ACTUAL,2018-08-31,ACTUAL,2018-08-31,2022-10,2022-10-31,2022-01-05,ACTUAL,2022-01-05,2021-01-05,ACTUAL,2021-01-05,,INTERVENTIONAL,POLEM,,Avelumab Plus 5-FU Based Chemotherapy as Adjuvant Treatment for Stage 3 MSI-High or POLE Mutant Colon Cancer,POLEM:Avelumab Plus 5-FU Based Chemotherapy as Adjuvant Treatment for Stage 3 MSI-High or POLE Exonuclease Domain Mutant Colon Cancer: A Phase 3 Randomised Study,TERMINATED,,PHASE3,30.0,ACTUAL,Royal Marsden NHS Foundation Trust,,2.0,,POLEM encountered significant recruitment challenges. With little prospect of recruiting to target the decision to close was made.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,OTHER,,,,,,,2022,0.0
NCT03748823,,2018-11-19,2022-08-09,2021-01-11,2024-08-16,2018-11-19,2018-11-21,ACTUAL,2022-10-10,2022-10-20,ACTUAL,2022-10-10,2022-10-20,ACTUAL,2024-08-16,2024-09-19,ACTUAL,2019-02-19,ACTUAL,2019-02-19,2024-08,2024-08-31,2023-08-31,ACTUAL,2023-08-31,2021-02-02,ACTUAL,2021-02-02,,INTERVENTIONAL,,"Full analysis set included all participants who had signed informed consent, were randomized, received at least 1 dose of ravulizumab, and were not excluded from analysis.",Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab,"A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label, Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab",COMPLETED,,PHASE3,139.0,ACTUAL,"Alexion Pharmaceuticals, Inc.","To ensure the quality of the study results, all 7 participants from a noncompliant investigative site were excluded from all prespecified analysis sets due to important source documentation deviations.",2.0,,,,,,,f,t,t,,,,,,,,,NO,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2023,1.0
NCT02129699,,2014-04-30,2022-12-01,,2024-09-09,2014-04-30,2014-05-02,ESTIMATED,2024-04-24,2024-04-25,ACTUAL,,,,2024-09-09,2024-09-19,ACTUAL,2015-01-06,ACTUAL,2015-01-06,2024-09,2024-09-30,2020-02-29,ACTUAL,2020-02-29,2020-02-29,ACTUAL,2020-02-29,,INTERVENTIONAL,SPLENDOUR,,Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy,"A Randomised, Open-label Phase III Trial Evaluating the Addition of Denosumab to Standard First-line Anticancer Treatment in Advanced NSCLC",TERMINATED,,PHASE3,595.0,ACTUAL,ETOP IBCSG Partners Foundation,The study steering committee decided to close the study prematurely due to poor accrual. The primary analysis is therefore underpowered.,2.0,,"Completion of recruitment was not feasible as accrual was slower than anticipated. Even if a benefit for denosumab could be shown, these results would be of very limited clinical impact by the time they would be available",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,NETWORK,,,,,,,2020,0.0
NCT03887702,,2019-03-21,2024-04-03,,2024-05-17,2019-03-21,2019-03-25,ACTUAL,2024-05-17,2024-05-20,ACTUAL,,,,2024-05-17,2024-05-20,ACTUAL,2020-01-17,ACTUAL,2020-01-17,2024-05,2024-05-31,2022-12-20,ACTUAL,2022-12-20,2022-12-20,ACTUAL,2022-12-20,,INTERVENTIONAL,,"There were no participants registered to the Chronic HBV infection cohort \[Cohort 1, Arms 1 and 2\]",Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors,A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors,TERMINATED,,PHASE3,4.0,ACTUAL,SWOG Cancer Research Network,"On November 15, 2022, the study was discontinued with no further follow-up required after it was determined that the accrual goal could not be met. Four participants had been accrued to Cohort 2 and no participants to Cohort 1. No adverse liver events, hepatitis B flares, or hepatitis B reactivations had occurred at the time the study was discontinued. As a result, planned time-to-event analyses for these outcomes could not be completed.",4.0,,inability to accrue,f,,,,t,t,f,,,,,,,,,,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,NETWORK,,,,,,,2022,0.0
NCT04609943,,2020-10-26,,,2024-09-08,2020-10-26,2020-10-30,ACTUAL,,,,,,,2024-09-08,2024-09-19,ACTUAL,2020-11-24,ACTUAL,2020-11-24,2024-09,2024-09-30,2023-09-14,ACTUAL,2023-09-14,2023-08-17,ACTUAL,2023-08-17,,INTERVENTIONAL,,,"Study to Find the Highest Safe Dose of Soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 Administered as Multiple Doses by Inhalation to Patients Who Cannot Breathe by Their Own and Suffer From a Type of Lung Failure That Causes Fluid to Build up in the Lungs Making Breathing Difficult (ARDS)","Safety and Tolerability of Adaptive Escalating Multiple Doses (Three Times Daily) of a Soluble Guanylate Cyclase (sGC) Activator Inhale, BAY 1211163, as Inhalation in Intubated and Mechanically Ventilated Adult Patients With Moderate and Severe Acute Respiratory Distress Syndrome (ARDS). A Pilot (Phase Ib), First in Patient, Open Label Study",TERMINATED,,PHASE1,16.0,ACTUAL,Bayer,,1.0,,Company Decision.,f,,,,t,f,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2023,0.0
NCT03205423,,2017-03-08,2022-06-27,,2024-08-21,2017-06-29,2017-07-02,ACTUAL,2022-09-29,2022-10-06,ACTUAL,,,,2024-08-21,2024-09-19,ACTUAL,2017-08-01,ACTUAL,2017-08-01,2024-08,2024-08-31,2021-12-30,ACTUAL,2021-12-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,,All enrolled participants.,Medication Development for Opioid and Alcohol Abuse,Medication Development for Opioid and Alcohol Abuse: Laboratory Study in Humans.,COMPLETED,,PHASE2,17.0,ACTUAL,New York State Psychiatric Institute,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,OTHER,,,,,,,2021,1.0
NCT02420717,,2015-04-15,2022-01-25,,2024-08-22,2015-04-15,2015-04-20,ESTIMATED,2022-04-28,2022-05-02,ACTUAL,,,,2024-08-22,2024-09-19,ACTUAL,2015-07-15,ACTUAL,2015-07-15,2024-08,2024-08-31,2021-01-20,ACTUAL,2021-01-20,2021-01-20,ACTUAL,2021-01-20,,INTERVENTIONAL,,,Ruxolitinib Phosphate or Dasatinib With Chemotherapy in Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia,A Phase I-II Study of the Combination of Ruxolitinib or Dasatinib With Chemotherapy in Patients With Philadelphia Chromosome (Ph)-Like Acute Lymphoblastic Leukemia (ALL),TERMINATED,,PHASE2,11.0,ACTUAL,M.D. Anderson Cancer Center,,3.0,,Study was closed early due to low accrual and lack of response.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,OTHER,,,,,,,2021,0.0
NCT05764265,,2023-01-10,,,2024-09-04,2023-03-01,2023-03-10,ACTUAL,,,,,,,2024-09-04,2024-09-19,ACTUAL,2023-03-27,ACTUAL,2023-03-27,2024-08,2024-08-31,2024-05-14,ACTUAL,2024-05-14,2024-04-26,ACTUAL,2024-04-26,,INTERVENTIONAL,,,Extension Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension Participants,"An Open-label Extension Study to Investigate Efficacy, Safety and Tolerability of LTP001 in Participants With Pulmonary Arterial Hypertension",TERMINATED,,PHASE2,31.0,ACTUAL,Novartis,,1.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2024,0.0
NCT01908725,,2013-06-12,,,2023-07-26,2013-07-23,2013-07-26,ESTIMATED,,,,,,,2023-07-26,2023-07-28,ACTUAL,2013-06,,2013-06-30,2023-07,2023-07-31,2022-09-30,ACTUAL,2022-09-30,2022-09-30,ACTUAL,2022-09-30,,INTERVENTIONAL,rhLAMAN-09,,Lamazym Aftercare Study,"A Single-center, Un-controlled, Open-labeled Trial of the Long-term Safety of Lamazym Aftercare Treatment of Subjects With Alpha-Mannosidosis Whom Previously Participated in Lamazym Trials",COMPLETED,,PHASE3,8.0,ACTUAL,Chiesi Farmaceutici S.p.A.,,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,INDUSTRY,,,,,,,2022,1.0
NCT04582864,,2020-09-25,,,2024-09-05,2020-10-07,2020-10-12,ACTUAL,,,,,,,2024-09-05,2024-09-19,ACTUAL,2021-05-20,ACTUAL,2021-05-20,2024-09,2024-09-30,2024-07-26,ACTUAL,2024-07-26,2024-03-29,ACTUAL,2024-03-29,,INTERVENTIONAL,,,Flotetuzumab for Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Following Allogeneic Hematopoietic Cell Transplantation (Allo-HCT),A Phase 2 Trial Evaluating the Efficacy of Flotetuzumab (MGD006) for Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Following Allogeneic Hematopoietic Cell Transplantation (Allo-HCT),TERMINATED,,PHASE2,11.0,ACTUAL,Washington University School of Medicine,,1.0,,The sponsor is no longer supporting the drug,f,,,,t,t,f,,,f,,,From 2 years to 10 years after accrual closure,IPD will be shared in de-identified form with investigators whose proposed use of the data has been approved by an independent review committee for that purpose.,,YES,De-identified participant data may be shared with other researchers.,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,OTHER,,,,,,,2024,0.0
NCT03269409,,2017-08-29,,,2021-12-21,2017-08-30,2017-08-31,ACTUAL,,,,,,,2021-12-21,2022-01-11,ACTUAL,2017-11-15,ACTUAL,2017-11-15,2021-12,2021-12-31,2021-06-28,ACTUAL,2021-06-28,2021-06-28,ACTUAL,2021-06-28,,INTERVENTIONAL,,,Use of Adipose Derived Regenerative Cells in Bilateral Femoral Head Osteonecrosis,"Double Blind, Phase I, Randomized, Parallel Group Study of Hip Decompression Compared to Hip Decompression Supplemented at the Point of Care With Adipose Derived Regenerative Cells for Bilateral Pre-Collapse Femoral Head Osteonecrosis",TERMINATED,,PHASE1,8.0,ACTUAL,Mayo Clinic,,2.0,,Logistical delays from device manufacturer due to COVID,f,,,,f,f,t,t,,,,,,,,,,2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,OTHER,,,,,,,2021,0.0
NCT03940352,,2019-05-02,,,2024-09-06,2019-05-06,2019-05-07,ACTUAL,,,,,,,2024-09-06,2024-09-19,ACTUAL,2019-06-24,ACTUAL,2019-06-24,2024-09,2024-09-30,2024-08-20,ACTUAL,2024-08-20,2024-08-20,ACTUAL,2024-08-20,,INTERVENTIONAL,,,HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS),"A Phase Ib, Multi-arm, Open-label, Study of HDM201 in Combination With MBG453 or Venetoclax in Adult Subjects With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)",TERMINATED,,PHASE1,52.0,ACTUAL,Novartis,,2.0,,Business decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2024,0.0
NCT05357898,,2022-04-18,,,2024-02-21,2022-04-27,2022-05-03,ACTUAL,,,,,,,2024-02-21,2024-02-23,ACTUAL,2022-03-24,ACTUAL,2022-03-24,2024-02,2024-02-29,2023-11-27,ACTUAL,2023-11-27,2023-11-27,ACTUAL,2023-11-27,,INTERVENTIONAL,,,"Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors","A Phase 1/2, First-in-Human, Multicenter, Open-Label Study of SQZ-eAPC-HPV as Monotherapy and in Combination With Immune Checkpoint Inhibitor(s) in Patients With HPV16+ Recurrent, Locally Advanced, or Metastatic Solid Tumors",TERMINATED,,PHASE1/PHASE2,20.0,ACTUAL,SQZ Biotechnologies,,3.0,,Corporate Decision,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:12:16.489128,2024-10-16 15:12:16.489128,INDUSTRY,,,,,,,2023,0.0
NCT03675126,,2018-08-06,2024-08-21,2022-08-22,2024-08-21,2018-09-14,2018-09-18,ACTUAL,2024-08-21,2024-09-19,ACTUAL,2022-08-22,2022-08-24,ACTUAL,2024-08-21,2024-09-19,ACTUAL,2018-12-19,ACTUAL,2018-12-19,2024-08,2024-08-31,2021-08-25,ACTUAL,2021-08-25,2021-08-25,ACTUAL,2021-08-25,,INTERVENTIONAL,,Safety Set: all participants who started the study drug infusion.,An Open-Label Extension Study for Patients With Duchenne Muscular Dystrophy Who Participated in Studies of SRP-5051 (Vesleteplirsen),An Open-Label Extension Study for Patients With Duchenne Muscular Dystrophy Who Participated in Studies of SRP-5051,TERMINATED,,PHASE1/PHASE2,15.0,ACTUAL,"Sarepta Therapeutics, Inc.",,1.0,,The sponsor has decided to integrate 5051-102 into 5051-201. Participants from 5051-102 will be eligible to enroll in 5051-201 Part B.,f,,,,t,t,f,,,,,,,,,,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2021,0.0
NCT04756427,,2021-02-11,2024-08-09,,2024-09-03,2021-02-11,2021-02-16,ACTUAL,2024-08-09,2024-09-04,ACTUAL,,,,2024-09-03,2024-09-19,ACTUAL,2022-03-28,ACTUAL,2022-03-28,2024-09,2024-09-30,2023-11-28,ACTUAL,2023-11-28,2023-11-28,ACTUAL,2023-11-28,,INTERVENTIONAL,,"Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.",Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition,Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition,TERMINATED,,PHASE4,1.0,ACTUAL,Johns Hopkins University,,1.0,,Subject recruitment was challenging,f,,,,f,t,f,,,t,,,,,,NO,"de-identified data (demographics, outcomes) may be shared upon request",2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,OTHER,,,,,,,2023,0.0
NCT03600805,,2018-07-17,2021-11-18,,2022-03-15,2018-07-17,2018-07-26,ACTUAL,2022-01-07,2022-01-14,ACTUAL,,,,2022-03-15,2022-03-28,ACTUAL,2018-11-20,ACTUAL,2018-11-20,2022-03,2022-03-31,2020-11-24,ACTUAL,2020-11-24,2020-11-24,ACTUAL,2020-11-24,,INTERVENTIONAL,,Analysis was performed on randomized population.,Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA,"A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis",TERMINATED,,PHASE3,83.0,ACTUAL,Sanofi,Study was prematurely discontinued due to protracted enrolment exacerbated by Covid-19 pandemic situation and not due to any safety issues from administration of sarilumab.,4.0,,Protracted recruitment timeline exacerbated by COVID-19 pandemic,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,INDUSTRY,,,,,,,2020,0.0
NCT04338321,,2020-04-06,2023-01-19,,2024-08-29,2020-04-06,2020-04-08,ACTUAL,2023-01-19,2023-02-15,ACTUAL,,,,2024-08-29,2024-09-19,ACTUAL,2020-08-21,ACTUAL,2020-08-21,2024-08,2024-08-31,2022-07-15,ACTUAL,2022-07-15,2022-01-20,ACTUAL,2022-01-20,,INTERVENTIONAL,ESCAPE-TRD,,"A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder","A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who Are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor",COMPLETED,,PHASE3,676.0,ACTUAL,Janssen-Cilag International NV,"To minimize potential bias, the Montgomery-Asberg Depression Rating Scale (MADRS) was performed by an independent on-site rater who was blinded to the participant's treatment, and who was not involved in any other study assessments or treatment decisions.",2.0,,,f,,,,f,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2022,1.0
NCT05567783,,2022-09-24,2024-05-03,,2024-08-15,2022-09-30,2022-10-05,ACTUAL,2024-08-15,2024-09-19,ACTUAL,,,,2024-08-15,2024-09-19,ACTUAL,2022-10-30,ACTUAL,2022-10-30,2024-05,2024-05-31,2023-08-31,ACTUAL,2023-08-31,2023-05-05,ACTUAL,2023-05-05,,INTERVENTIONAL,,All participants who received any amount of study intervention.,A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A,"A Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A",TERMINATED,,PHASE2,2977.0,ACTUAL,"Vir Biotechnology, Inc.",,3.0,,VIR-2482 1200 mg did not demonstrate efficacy versus placebo in the primary analysis of the primary endpoint,f,,,,t,t,f,,,,,,,,,YES,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2023,0.0
NCT02680626,,2016-02-09,,,2023-04-11,2016-02-09,2016-02-11,ESTIMATED,,,,,,,2023-04-11,2023-04-13,ACTUAL,2016-01,,2016-01-31,2023-04,2023-04-30,2020-02,ACTUAL,2020-02-29,2020-02,ACTUAL,2020-02-29,,INTERVENTIONAL,,,Bilateral Transversus Abdominis Plane Block With or Without Magnesium,Bilateral Transversus Abdominis Plane Block With or Without Magnesium for Total Abdominal Hysterectomy With or Without Salpingo-oophorectomy: a Randomized Controlled Trial,TERMINATED,,PHASE4,86.0,ACTUAL,Queen's University,,2.0,,Pfannenstiel hysterectomies are now rarely performed so cannot recruit eligible patients,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,OTHER,,,,,,,2020,0.0
NCT04825678,,2021-03-29,2024-08-08,,2024-09-11,2021-03-29,2021-04-01,ACTUAL,2024-09-11,2024-09-19,ACTUAL,,,,2024-09-11,2024-09-19,ACTUAL,2021-06-11,ACTUAL,2021-06-11,2024-09,2024-09-30,2023-09-28,ACTUAL,2023-09-28,2023-09-28,ACTUAL,2023-09-28,,INTERVENTIONAL,,Full Analysis Set (FAS): consisted of all participants enrolled in the study.,A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine,"Phase 4, Open-label Study to Evaluate Treatment Satisfaction With Erenumab in Patients With Migraine",COMPLETED,,PHASE4,240.0,ACTUAL,Amgen,,1.0,,,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",http://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2023,1.0
NCT04494256,,2020-07-30,,,2024-09-04,2020-07-30,2020-07-31,ACTUAL,,,,,,,2024-09-04,2024-09-19,ACTUAL,2020-09-28,ACTUAL,2020-09-28,2024-09,2024-09-30,2024-08-13,ACTUAL,2024-08-13,2024-08-13,ACTUAL,2024-08-13,,INTERVENTIONAL,ALSpire,,"A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation","A Phase 1/2 Multiple-Ascending-Dose Study With a Long-Term Open-Label Extension to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effect on Disease Progression of BIIB105 Administered Intrathecally to Adults With Amyotrophic Lateral Sclerosis With or Without Poly-CAG Expansion in the ATXN2 Gene",TERMINATED,,PHASE1/PHASE2,99.0,ACTUAL,Biogen,,9.0,,Sponsor's decision,f,,,,f,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2024,0.0
NCT04258150,,2020-02-04,,,2022-03-15,2020-02-05,2020-02-06,ACTUAL,,,,,,,2022-03-15,2022-03-31,ACTUAL,2020-04-16,ACTUAL,2020-04-16,2022-03,2022-03-31,2021-11-23,ACTUAL,2021-11-23,2021-11-23,ACTUAL,2021-11-23,,INTERVENTIONAL,TRIPPLE-R,,"Ipilimumab, Nivolumab, Tocilizumab and Radiation in Pretreated Patients With Advanced Pancreatic Cancer","TRIPPLE-R: Phase 2 Study in Pretreated Patients With Advanced Pancreatic Cancer to Assess Efficacy of Ipilimumab, Nivolumab and Tocilizumab in Combination With Radiation",TERMINATED,,PHASE2,26.0,ACTUAL,Herlev Hospital,,1.0,,primary endpoint was not met,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,OTHER,,,,,,,2021,0.0
NCT05122975,,2021-10-22,,,2024-09-10,2021-11-11,2021-11-17,ACTUAL,,,,,,,2024-09-10,2024-09-19,ACTUAL,2023-08-01,ACTUAL,2023-08-01,2024-09,2024-09-30,2024-04-01,ACTUAL,2024-04-01,2024-04-01,ACTUAL,2024-04-01,,INTERVENTIONAL,,,Treatment of an Inherited Ventricular Arrhythmia,Treatment of Catecholaminergic Polymorphic Ventricular Tachycardia Type 1 (CPVT1),TERMINATED,,PHASE2,8.0,ACTUAL,"Armgo Pharma, Inc.",,2.0,,Due to challenges in recruiting patients.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2024,0.0
NCT05408429,,2022-06-01,2024-05-14,,2024-05-14,2022-06-01,2022-06-07,ACTUAL,2024-05-14,2024-09-19,ACTUAL,,,,2024-05-14,2024-09-19,ACTUAL,2022-06-24,ACTUAL,2022-06-24,2024-05,2024-05-31,2023-06-01,ACTUAL,2023-06-01,2023-06-01,ACTUAL,2023-06-01,,INTERVENTIONAL,,Safety population included all participants who receive at least 1 dose of the study intervention and have safety data reported after any dose.,Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13,"A PHASE 3, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY TODDLERS 12 THROUGH 23 MONTHS OF AGE WITH 2 PRIOR INFANT DOSES OF PREVENAR 13",COMPLETED,,PHASE3,356.0,ACTUAL,Pfizer,,3.0,,,f,,,,t,f,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2023,1.0
NCT03777982,,2018-12-14,2024-08-06,,2024-09-04,2018-12-14,2018-12-19,ACTUAL,2024-09-04,2024-09-19,ACTUAL,,,,2024-09-04,2024-09-19,ACTUAL,2020-04-20,ACTUAL,2020-04-20,2024-09,2024-09-30,2024-02-13,ACTUAL,2024-02-13,2024-02-13,ACTUAL,2024-02-13,,INTERVENTIONAL,,Those who initiate the treatment,Conventional Androgen Deprivation Therapy (ADT) With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT,A Randomized Phase III Study - Conventional Androgen Deprivation Therapy With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and Androgen Deprivation Therapy,TERMINATED,,PHASE3,12.0,ACTUAL,Dana-Farber Cancer Institute,,2.0,,PI is terminating the study due to slow/low accrual,f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication.,Requests may be directed to: \[contact information for Sponsor-Investigator or designee\].,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor-Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,OTHER,,,,,,,2024,0.0
NCT03355573,,2017-11-22,,2023-10-18,2024-09-09,2017-11-22,2017-11-28,ACTUAL,,,,,2023-10-24,ACTUAL,2024-09-09,2024-09-19,ACTUAL,2017-11-28,ACTUAL,2017-11-28,2024-09,2024-09-30,2022-10-19,ACTUAL,2022-10-19,2022-10-19,ACTUAL,2022-10-19,,INTERVENTIONAL,BE AGILE 2,,A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis,"A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis",COMPLETED,,PHASE2,255.0,ACTUAL,UCB Pharma,,1.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2022,1.0
NCT04035603,,2019-06-19,,,2021-02-10,2019-07-25,2019-07-29,ACTUAL,,,,,,,2021-02-10,2021-02-12,ACTUAL,2020-10-01,ESTIMATED,2020-10-01,2021-02,2021-02-28,2021-01-31,ESTIMATED,2021-01-31,2021-01-31,ESTIMATED,2021-01-31,,INTERVENTIONAL,,,Multimodal Cue Exposure Therapy for Smoking Cessation,Multimodal CET for Smoking Cessation Augmented With D-cycloserine,WITHDRAWN,,PHASE2,0.0,ACTUAL,Boston University Charles River Campus,,2.0,,Never received funding,f,,,,t,f,f,,,f,,,One year after publication of primary aims,Institutional IRB approval,,YES,One year after publication of the primary aims from this project the primary and fully de-identified IPD will be made available by the investigators on CD for other researchers providing documented IRB consent from their institution.,2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,OTHER,,,,,,,2021,0.0
NCT04410991,,2020-05-28,,,2024-09-13,2020-05-28,2020-06-01,ACTUAL,,,,,,,2024-09-13,2024-09-19,ACTUAL,2020-06-11,ACTUAL,2020-06-11,2024-09,2024-09-30,2024-07-16,ACTUAL,2024-07-16,2024-07-16,ACTUAL,2024-07-16,,INTERVENTIONAL,GEMINI 2,,Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2),"A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis",COMPLETED,,PHASE3,899.0,ACTUAL,Sanofi,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2024,1.0
NCT03937999,,2019-05-02,2022-09-15,,2022-10-13,2019-05-02,2019-05-06,ACTUAL,2022-10-13,2022-11-09,ACTUAL,,,,2022-10-13,2022-11-09,ACTUAL,2019-08-30,ACTUAL,2019-08-30,2022-10,2022-10-31,2022-05-15,ACTUAL,2022-05-15,2022-05-15,ACTUAL,2022-05-15,,INTERVENTIONAL,,Only 1 participant was enrolled in the study (control group). Study terminated early due to lack of enrollment,Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.,A Pragmatic Trial of Secondary Prophylaxis With Bezlotoxumab to Prevent C. Difficile Relapse Among Hospitalized Adults Receiving Antibiotics.,TERMINATED,,PHASE4,1.0,ACTUAL,Montefiore Medical Center,,2.0,,"Slow enrollment due to COVID19 , change in practice with standardized use of oral vancomycin prophylaxis",f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 06:35:00.136655,2024-10-15 06:35:00.136655,OTHER,,,,,,,2022,0.0
NCT03922100,,2019-04-04,,,2024-09-12,2019-04-18,2019-04-19,ACTUAL,,,,,,,2024-09-12,2024-09-19,ACTUAL,2019-04-03,ACTUAL,2019-04-03,2024-09,2024-09-30,2024-08-29,ACTUAL,2024-08-29,2024-08-29,ACTUAL,2024-08-29,,INTERVENTIONAL,,,Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML,"A Phase I/II Study of NMS-03592088, a FLT3, KIT and CSF1R Inhibitor, in Patients With Relapsed or Refractory AML or CMML",TERMINATED,,PHASE1/PHASE2,63.0,ACTUAL,Nerviano Medical Sciences,,1.0,,Study stopped due to strategic reasons. The decision is not based on specific safety findings as the safety observed in the phase II part of the study is in line with what was reported in the phase I part.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,INDUSTRY,,,,,,,2024,0.0
NCT04467905,,2020-07-08,2024-08-01,,2024-09-16,2020-07-08,2020-07-13,ACTUAL,2024-09-16,2024-09-19,ACTUAL,,,,2024-09-16,2024-09-19,ACTUAL,2020-11-19,ACTUAL,2020-11-19,2024-08,2024-08-31,2023-08-10,ACTUAL,2023-08-10,2023-08-03,ACTUAL,2023-08-03,,INTERVENTIONAL,,Safety/mITT Population,"ReVeRA-201: Etripamil in Atrial Fibrillation, Phase 2","Multi-Centre, Placebo-Controlled, Phase 2 Study of Etripamil Nasal Spray (NS) for the Reduction of Ventricular Rate in Patients With Atrial Fibrillation.",COMPLETED,,PHASE2,69.0,ACTUAL,Milestone Pharmaceuticals Inc.,,2.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,OTHER,,,,,,,2023,1.0
NCT04807517,,2021-03-17,2024-07-23,,2024-08-20,2021-03-17,2021-03-19,ACTUAL,2024-08-20,2024-09-19,ACTUAL,,,,2024-08-20,2024-09-19,ACTUAL,2021-08-01,ACTUAL,2021-08-01,2024-08,2024-08-31,2023-09-11,ACTUAL,2023-09-11,2023-09-11,ACTUAL,2023-09-11,,INTERVENTIONAL,,,Buspirone Treatment of Anxiety in Williams Syndrome,Buspirone for the Treatment of Anxiety in Williams Syndrome,COMPLETED,,PHASE4,20.0,ACTUAL,Massachusetts General Hospital,,1.0,,,f,,,,,t,f,,,t,,,,,,,,2024-10-15 03:54:18.59957,2024-10-15 03:54:18.59957,OTHER,,,,,,,2023,1.0
NCT04484493,,2020-07-22,,,2020-11-11,2020-07-22,2020-07-23,ACTUAL,,,,,,,2020-11-11,2020-11-13,ACTUAL,2020-08-08,ACTUAL,2020-08-08,2020-11,2020-11-30,2020-11-03,ACTUAL,2020-11-03,2020-10-25,ACTUAL,2020-10-25,,INTERVENTIONAL,,,Corticosteroid Nasal Spray in COVID-19 Anosmia,Role of Corticosteroid Nasal Spray in Recovery of Smell Sensation in COVID-19 Patients,COMPLETED,,PHASE3,100.0,ACTUAL,Benha University,,2.0,,,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,OTHER,,,,,,,2020,0.0
NCT03521570,,2018-04-30,2023-12-21,,2024-09-14,2018-04-30,2018-05-11,ACTUAL,2024-09-14,2024-09-19,ACTUAL,,,,2024-09-14,2024-09-19,ACTUAL,2018-06-28,ACTUAL,2018-06-28,2024-09,2024-09-30,2023-09-07,ACTUAL,2023-09-07,2022-07-25,ACTUAL,2022-07-25,,INTERVENTIONAL,,,Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer,Phase II Study of IMRT Re-Irradiation With Concurrent/Adjuvant Nivolumab in Patients With Locoregionally Recurrent or Second Primary Squamous Cell Cancer of the Head and Neck,COMPLETED,,PHASE2,62.0,ACTUAL,Emory University,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,OTHER,,,,,,,2023,1.0
NCT01724346,,2012-11-02,2024-07-17,,2024-08-26,2012-11-06,2012-11-09,ESTIMATED,2024-08-26,2024-09-19,ACTUAL,,,,2024-08-26,2024-09-19,ACTUAL,2013-12-03,ACTUAL,2013-12-03,2024-08,2024-08-31,2023-08-18,ACTUAL,2023-08-18,2023-08-18,ACTUAL,2023-08-18,,INTERVENTIONAL,,,Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma,An Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib Versus Chlorambucil),COMPLETED,,PHASE3,269.0,ACTUAL,Pharmacyclics LLC.,,2.0,,,f,,,,f,t,f,,,f,,,,,http://yoda.yale.edu,YES,"Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.",2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,INDUSTRY,,,,,,,2023,1.0
NCT02055963,,2014-02-04,2022-08-29,,2022-10-18,2014-02-04,2014-02-05,ESTIMATED,2022-09-26,2022-10-18,ACTUAL,,,,2022-10-18,2022-10-20,ACTUAL,2014-05-06,ACTUAL,2014-05-06,2022-10,2022-10-31,2022-08-11,ACTUAL,2022-08-11,2022-08-11,ACTUAL,2022-08-11,,INTERVENTIONAL,,,Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer,Minocycline for Reduction of Symptom Burden After Surgery in Patients With Head and Neck Malignancy: A Randomized Study,TERMINATED,,PHASE2,30.0,ACTUAL,M.D. Anderson Cancer Center,Early termination due to the protocol lack of progress in improving accrual rate.,2.0,,Early termination due to the protocol lack of progress in improving accrual rate,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,OTHER,,,,,,,2022,0.0
NCT03649841,,2018-08-22,2023-08-28,,2023-10-15,2018-08-24,2018-08-28,ACTUAL,2023-10-15,2023-10-26,ACTUAL,,,,2023-10-15,2023-10-26,ACTUAL,2020-06-29,ACTUAL,2020-06-29,2023-10,2023-10-31,2023-02-01,ACTUAL,2023-02-01,2022-09-01,ACTUAL,2022-09-01,,INTERVENTIONAL,,,"Antiandrogen Therapy, Abiraterone Acetate, and Prednisone With or Without Neutron Radiation Therapy in Treating Patients With Prostate Cancer",Radiation Enhancement of Local and Systemic Anti-Prostate Cancer Immune Responses,TERMINATED,,PHASE2,10.0,ACTUAL,University of Washington,Early termination due to poor patient accrual leading to small numbers of subjects analyzed.,2.0,,Terminated due to low accrual.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,OTHER,,,,,,,2023,0.0
NCT04134091,,2019-08-16,2023-08-14,,2023-12-12,2019-10-18,2019-10-21,ACTUAL,2023-12-12,2023-12-14,ACTUAL,,,,2023-12-12,2023-12-14,ACTUAL,2019-08-27,ACTUAL,2019-08-27,2023-12,2023-12-31,2021-06-24,ACTUAL,2021-06-24,2021-06-24,ACTUAL,2021-06-24,,INTERVENTIONAL,NASH,All randomized participants.,"The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis","A Phase 2, Randomized Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis (NASH)",COMPLETED,,PHASE2,56.0,ACTUAL,Lipocine Inc.,,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,INDUSTRY,,,,,,,2021,1.0
NCT03762564,,2018-11-27,,,2022-12-07,2018-11-30,2018-12-03,ACTUAL,,,,,,,2022-12-07,2022-12-08,ACTUAL,2019-03-08,ACTUAL,2019-03-08,2022-12,2022-12-31,2022-11-25,ACTUAL,2022-11-25,2022-07-04,ACTUAL,2022-07-04,,INTERVENTIONAL,RAMOS,,Study With Paclitaxel +/- Ramucirumab in Patients With Squamous-cell Carcinoma of the Esophagus After Prior Therapy,"A Randomized, Multicenter Open Label Phase II Trial of Paclitaxel + Ramucirumab Versus Paclitaxel Alone in Patients With Squamous-cell Carcinoma of the Esophagus, Refractory or Intolerant to Combination Therapy With Fluoropyrimidine and Platinum-based Drugs - The RAMOS STUDY",COMPLETED,,PHASE2,21.0,ACTUAL,Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest,,2.0,,,f,,,,,f,f,,,,,,,,,NO,No IPD will be shared,2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,OTHER,,,,,,,2022,1.0
NCT04184518,,2019-11-29,,,2020-05-29,2019-12-02,2019-12-03,ACTUAL,,,,,,,2020-05-29,2020-06-02,ACTUAL,2020-05,ESTIMATED,2020-05-31,2020-05,2020-05-31,2021-12,ESTIMATED,2021-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,CEDUVEAL-M,,Durvalumab (MEDI4736) Plus Cediranib in Patients With Metastatic Uveal Melanoma,"Phase II, Open-Label Study of Preliminary Efficacy of Durvalumab (MEDI4736) in Combination With Cediranib in Patients With Metastatic Uveal Melanoma",WITHDRAWN,,PHASE2,0.0,ACTUAL,Grupo Español Multidisciplinar de Melanoma,,1.0,,The Cediranib producer laboratory decided to stop the development of this product.,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,OTHER,,,,,,,2021,0.0
NCT03235739,,2017-07-18,2022-09-14,,2023-08-14,2017-07-28,2017-08-01,ACTUAL,2023-08-14,2023-09-05,ACTUAL,,,,2023-08-14,2023-09-05,ACTUAL,2017-10-01,ACTUAL,2017-10-01,2023-08,2023-08-31,2022-05-23,ACTUAL,2022-05-23,2021-05-31,ACTUAL,2021-05-31,,INTERVENTIONAL,,,Ancillary Effects of Oral Naloxegol (Movantik),Ancillary Effects of Oral Naloxegol (Movantik),COMPLETED,,PHASE4,136.0,ACTUAL,The Cleveland Clinic,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,Data to be provided in aggregate without patient identifiers,2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,OTHER,,,,,,,2022,1.0
NCT03912337,,2019-04-10,2022-05-27,,2022-07-18,2019-04-10,2019-04-11,ACTUAL,2022-07-18,2022-07-20,ACTUAL,,,,2022-07-18,2022-07-20,ACTUAL,2019-12-04,ACTUAL,2019-12-04,2022-07,2022-07-31,2021-07-28,ACTUAL,2021-07-28,2021-07-28,ACTUAL,2021-07-28,,INTERVENTIONAL,,The respective full analysis set consisted of all participants who were randomized in the study through traditional study sites or decentralized clinical trial sites (DCTS).,Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine,Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine Who Have Previously Failed 1 or More Migraine Preventive Treatments.,TERMINATED,,PHASE4,29.0,ACTUAL,Amgen,"The study was terminated early due to slow enrollment and the impact of COVID-19 on the work productivity study endpoints, beyond normal operational disruptions.",2.0,,Terminated \[Study would not complete enrollment target until 2026 with results available in 2027. The information will not be useful at that time.\],,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,INDUSTRY,,,,,,,2021,0.0
NCT02914600,,2016-09-22,2024-05-29,,2024-07-04,2016-09-22,2016-09-26,ESTIMATED,2024-07-04,2024-07-10,ACTUAL,,,,2024-07-04,2024-07-10,ACTUAL,2017-03-17,ACTUAL,2017-03-17,2024-05,2024-05-31,2023-08-01,ACTUAL,2023-08-01,2023-08-01,ACTUAL,2023-08-01,,INTERVENTIONAL,DIVERSITY LTE,Safety analysis set included all participants who took at least 1 dose of study drug in this study.,Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease,A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease,TERMINATED,,PHASE3,1188.0,ACTUAL,Galapagos NV,"The results of DIVERSITY 1 study with filgotinib in participants with moderate to severely active CD failed to meet the co-primary endpoints of clinical remission and endoscopic response for filgotinib 100 mg q.d. and 200 mg q.d. in the study. After analyzing all available data from the DIVERSITY 1 and DIVERSITY long term extension (LTE) studies, the sponsor decided not to pursue extension of the filgotinib indication for CD and decided to terminate the DIVERSITY LTE study.",3.0,,development program for filgotinib for participants with Crohn's disease has been stopped,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,INDUSTRY,,,,,,,2023,0.0
NCT04274114,,2020-02-14,,,2021-02-08,2020-02-17,2020-02-18,ACTUAL,,,,,,,2021-02-08,2021-02-11,ACTUAL,2019-01-18,ACTUAL,2019-01-18,2021-02,2021-02-28,2020-05-12,ACTUAL,2020-05-12,2020-05-12,ACTUAL,2020-05-12,,INTERVENTIONAL,,,Treatment of Adults With Generalized Anxiety Disorder Using Glutamine,Efficacy of L-glutamine for the Treatment of Generalized Anxiety Disorder: a Randomized Controlled Trial,TERMINATED,,PHASE2,38.0,ACTUAL,Hospital Universitario Dr. Jose E. Gonzalez,,2.0,,Inhability to recruit further participants due to SARS-CoV-2 pandemics.,f,,,,,f,f,,,,,,,,,,,2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,OTHER,,,,,,,2020,0.0
NCT04541147,,2020-09-01,,,2024-02-23,2020-09-01,2020-09-09,ACTUAL,,,,,,,2024-02-23,2024-02-28,ACTUAL,2021-04-14,ACTUAL,2021-04-14,2024-02,2024-02-29,2023-12-26,ACTUAL,2023-12-26,2023-12-26,ACTUAL,2023-12-26,,INTERVENTIONAL,,,Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients,A Randomized Control Trial of Post-operative Course of Oral Dexamethasone and Effect on Opioid Usage in Pediatric Tonsillectomies in a Tertiary Care Center,TERMINATED,,PHASE4,24.0,ACTUAL,Duke University,,2.0,,Lack of funding,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,OTHER,,,,,,,2023,0.0
NCT03871361,,2019-03-05,,,2023-12-01,2019-03-11,2019-03-12,ACTUAL,,,,,,,2023-12-01,2023-12-04,ACTUAL,2019-04-01,ACTUAL,2019-04-01,2023-12,2023-12-31,2023-12-01,ACTUAL,2023-12-01,2022-01-01,ACTUAL,2022-01-01,,INTERVENTIONAL,HLA-A29,,Abatacept in Patients With Birdshot HLA A29 Uveitis,Abatacept in Patients With Birdshot HLA A29 Uveitis: A Phase II Prospective 0pen Label Interventional Proof-of-Concept Study,COMPLETED,,PHASE2,15.0,ACTUAL,Universitaire Ziekenhuizen KU Leuven,,1.0,,,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,OTHER,,,,,,,2023,1.0
NCT04298918,,2020-03-05,2021-10-08,,2021-10-08,2020-03-05,2020-03-06,ACTUAL,2021-10-08,2021-11-08,ACTUAL,,,,2021-10-08,2021-11-08,ACTUAL,2020-09-23,ACTUAL,2020-09-23,2021-10,2021-10-31,2021-02-04,ACTUAL,2021-02-04,2021-02-04,ACTUAL,2021-02-04,,INTERVENTIONAL,,"The study was terminated by the Sponsor. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.",A Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Trastuzumab Emtansine in Patients With Previously Treated HER2-Positive Locally Advanced or Metastatic Breast Cancer,"A Phase lb/ll, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Venetoclax in Combination With Trastuzumab Emtansine in Patients With Previously Treated HER2-Positive Locally Advanced or Metastatic Breast Cancer",TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,Hoffmann-La Roche,"The study was terminated by the Sponsor. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.",4.0,,Decision to discontinue the study based on broader development and strategic prioritisation. The Sponsor concludes there is no benefit-risk impact on the CO41863 study.,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,INDUSTRY,,,,,,,2021,0.0
NCT05731492,,2023-02-09,,,2024-05-27,2023-02-09,2023-02-16,ACTUAL,,,,,,,2024-05-27,2024-05-29,ACTUAL,2024-03-14,ESTIMATED,2024-03-14,2024-05,2024-05-31,2024-04-01,ESTIMATED,2024-04-01,2024-04-01,ESTIMATED,2024-04-01,,INTERVENTIONAL,,,A Study of Macitentan in Children Below 2 Years of Age,"A Multicenter, Open-label, Single-arm Study to Assess the Pharmacokinetics and Safety of Macitentan in Children Aged 1 Month to <2 Years With Pulmonary Arterial Hypertension",WITHDRAWN,,PHASE1,0.0,ACTUAL,Actelion,,1.0,,Sponsor Decision,f,,,,t,t,f,,,f,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-16 15:17:48.281651,2024-10-16 15:17:48.281651,INDUSTRY,,,,,,,2024,0.0
NCT02957097,,2016-07-21,,,2023-01-25,2016-11-04,2016-11-06,ESTIMATED,,,,,,,2023-01-25,2023-01-26,ACTUAL,2019-09,ESTIMATED,2019-09-30,2023-01,2023-01-31,2021-07,ESTIMATED,2021-07-31,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures,Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures,WITHDRAWN,,PHASE4,0.0,ACTUAL,Massachusetts General Hospital,,2.0,,Original PI left institution and the PI who took over was not able to initiate the study so it was never started.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2021,0.0
NCT03649477,,2018-08-24,2021-08-30,,2022-07-18,2018-08-24,2018-08-28,ACTUAL,2021-10-19,2021-11-17,ACTUAL,,,,2022-07-18,2022-07-26,ACTUAL,2018-11-20,ACTUAL,2018-11-20,2021-08,2021-08-31,2022-07-09,ACTUAL,2022-07-09,2020-05-13,ACTUAL,2020-05-13,,INTERVENTIONAL,CARE-PWS,,Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome,"Phase 3, Randomized, Double-Blind, Placebo-Controlled, 8-week Clinical Study to Assess the Efficacy, Safety, and Tolerability, of Intranasal Carbetocin (LV-101) in Prader-Willi Syndrome (PWS) With Long Term Follow-Up (CARE-PWS)",COMPLETED,,PHASE3,130.0,ACTUAL,"Levo Therapeutics, Inc.","The COVID-19 pandemic began affecting this study in early March 2020 by substantially impacting the ability to safely enroll clinical study subjects, by requiring remote visits and monitoring, and by dramatically changing daily routines and social environments in this sensitive PWS population. Levo held new screening and enrollment in March 2020, and subsequently closed screening and enrollment in May 2020, resulting in the enrollment of 130 subjects instead of the 175 subjects planned.",3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,INDUSTRY,,,,,,,2022,1.0
NCT04230330,,2020-01-13,,,2020-11-03,2020-01-14,2020-01-18,ACTUAL,,,,,,,2020-11-03,2020-11-05,ACTUAL,2019-12-12,ACTUAL,2019-12-12,2020-11,2020-11-30,2020-06-12,ACTUAL,2020-06-12,2020-06-12,ACTUAL,2020-06-12,,INTERVENTIONAL,,,Nivolumab in Combination With GDP/ L-asparaginase in NK/ T-cell Lymphoma,"A Pilot Study of Nivolumab in Combination With GDP (Gemcitabine, Dexamethasone, Cisplatin)/ L-asparaginase in Patients With Advanced Stage or Relapsed/ Refractory Natural-killer/ T-cell Lymphoma",WITHDRAWN,,PHASE1,0.0,ACTUAL,"National Cancer Centre, Singapore",,2.0,,PI has left the institution.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2020,0.0
NCT04760782,,2021-02-15,2024-06-17,,2024-08-26,2021-02-17,2021-02-18,ACTUAL,2024-08-26,2024-09-19,ACTUAL,,,,2024-08-26,2024-09-19,ACTUAL,2022-05-18,ACTUAL,2022-05-18,2024-08,2024-08-31,2023-08-14,ACTUAL,2023-08-14,2023-08-14,ACTUAL,2023-08-14,,INTERVENTIONAL,,,PTH Analog Type II Odontoid Fracture,Effect of PTH Analog on Union Rates of Type II Odontoid Fractures in Older Adults,TERMINATED,,PHASE2,22.0,ACTUAL,University of Vermont,Early termination due to recruitment barriers and slow recruitment rate. Insufficient statistical power for analyses with data collected before study termination.,2.0,,Study terminated early due to low recruitment rate.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,OTHER,,,,,,,2023,0.0
NCT00904345,,2009-05-17,2020-12-23,,2021-02-03,2009-05-18,2009-05-19,ESTIMATED,2020-12-23,2021-01-20,ACTUAL,,,,2021-02-03,2021-02-24,ACTUAL,2009-04,,2009-04-30,2021-02,2021-02-28,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC),Phase II Study of RT Concurrent w/ Cetuximab in Patients w/ Locally Advanced Head & Neck SCC Who Do Not Qualify For Standard Chemotherapy Due To Age >70 Or Co-Morbidities,TERMINATED,,PHASE2,23.0,ACTUAL,University of Michigan Rogel Cancer Center,,1.0,,Stopped early for funding and efficacy reasons.,f,,,,t,,,,,,,,,,,,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2020,0.0
NCT03604783,,2018-07-18,,,2024-09-05,2018-07-19,2018-07-27,ACTUAL,,,,,,,2024-09-05,2024-09-19,ACTUAL,2018-12-26,ACTUAL,2018-12-26,2024-09,2024-09-30,2024-01-10,ACTUAL,2024-01-10,2024-01-10,ACTUAL,2024-01-10,,INTERVENTIONAL,,,"Phase 1, First-in-human Study of Oral TP-1287 in Patients with Advanced Solid Tumors","A Phase 1, First-in-human, Open-label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-1287 to Patients with Advanced Solid Tumors",TERMINATED,,PHASE1,74.0,ACTUAL,"Sumitomo Pharma America, Inc.",,1.0,,Sponsor's decision to terminate further development of the program.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,INDUSTRY,,,,,,,2024,0.0
NCT04383210,,2020-05-07,,,2024-09-11,2020-05-07,2020-05-12,ACTUAL,,,,,,,2024-09-11,2024-09-19,ACTUAL,2024-02-28,ACTUAL,2024-02-28,2024-09,2024-09-30,2024-02-28,ACTUAL,2024-02-28,2024-02-28,ACTUAL,2024-02-28,,INTERVENTIONAL,,,Study of Seribantumab in Adult Patients with NRG1 Gene Fusion Positive Advanced Solid Tumors,CRESTONE: a Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors,TERMINATED,,PHASE2,54.0,ACTUAL,Elevation Oncology,,3.0,,Business decision,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,INDUSTRY,,,,,,,2024,0.0
NCT03128905,,2017-04-06,,,2022-11-28,2017-04-21,2017-04-25,ACTUAL,,,,,,,2022-11-28,2022-11-29,ACTUAL,2018-02-05,ACTUAL,2018-02-05,2022-11,2022-11-30,2022-05-13,ACTUAL,2022-05-13,2022-05-13,ACTUAL,2022-05-13,,INTERVENTIONAL,COLCHICORT,,Trial of Colchicine Versus Prednisone for the Treatment of Acute CPPD Arthritis,"Colchicine or Prednisone for the Treatment of Acute Calcium Pyrophosphate Deposition (CPPD) Arthritis: Open-label, Randomized, Multicenter, Equivalence Trial of Efficacy and Safety",COMPLETED,,PHASE3,111.0,ACTUAL,Lille Catholic University,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2022,1.0
NCT03691376,,2018-09-27,,,2024-09-06,2018-09-28,2018-10-01,ACTUAL,,,,,,,2024-09-06,2024-09-19,ACTUAL,2019-03-08,ACTUAL,2019-03-08,2024-09,2024-09-30,2024-06-24,ACTUAL,2024-06-24,2021-01-30,ACTUAL,2021-01-30,,INTERVENTIONAL,,,"Genetically Engineered Cells (NY-ESO-1 TCR Engineered T Cells and HSCs) After Melphalan Conditioning Regimen in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","A Phase I, Open Label Study Evaluating the Safety and Efficacy of Adoptive Transfer of Autologous NY-ESO-1 CD8-TCR Engineered T Cells and NY-ESO-1 CD4-TCR Engineered Hematopoietic Stem Cells (HSC) After a Myeloablative Conditioning Regimen, With Administration of IL-2 in Patients With Recurrent or Treatment Refractory Ovarian, Fallopian Tube or Primary Peritoneal Cancer",TERMINATED,,PHASE1,4.0,ACTUAL,Roswell Park Cancer Institute,,1.0,,Lack of funding,,,,,t,t,f,,,t,,,,,,,,2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,OTHER,,,,,,,2024,0.0
NCT04739566,,2021-01-29,,,2024-03-21,2021-02-03,2021-02-04,ACTUAL,,,,,,,2024-03-21,2024-03-25,ACTUAL,2021-01-22,ACTUAL,2021-01-22,2024-03,2024-03-31,2023-12-22,ACTUAL,2023-12-22,2023-12-22,ACTUAL,2023-12-22,,INTERVENTIONAL,ANAPLAST-NEO,,Dabrafenib and Trametinib Combination as a Neoadjuvant Strategy in BRAF-positive Anaplastic Thyroid Cancer,Dabrafenib and Trametinib Combination as a Neoadjuvant Strategy in BRAF-positive Anaplastic Thyroid Cancer (ANAPLAST-NEO),WITHDRAWN,,PHASE2,0.0,ACTUAL,"Saint Petersburg State University, Russia",,1.0,,Lack of funding,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2023,0.0
NCT05628545,,2022-11-02,,,2023-01-16,2022-11-16,2022-11-28,ACTUAL,,,,,,,2023-01-16,2023-01-18,ACTUAL,2021-11-01,ACTUAL,2021-11-01,2023-01,2023-01-31,2024-10-31,ESTIMATED,2024-10-31,2023-02-28,ESTIMATED,2023-02-28,,INTERVENTIONAL,,,Adoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells,Clinical Study on Adoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Guangdong GD Kongming Biotech LLC,,1.0,,COVID1-19 pandemic,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,INDUSTRY,,,,,,,2024,0.0
NCT04455139,,2020-04-24,,,2023-09-28,2020-06-29,2020-07-02,ACTUAL,,,,,,,2023-09-28,2023-10-03,ACTUAL,2021-11-15,ACTUAL,2021-11-15,2023-09,2023-09-30,2023-05-22,ACTUAL,2023-05-22,2023-05-22,ACTUAL,2023-05-22,,INTERVENTIONAL,EuRbG2018,,A Prospective International Multicenter Clinical Trial for Eyes With Relapsed Retinoblastoma,"A Phase II Prospective International Multicenter Clinical Trial for Eyes With Relapsed Retinoblastoma, With Randomization Depending on the Site of Relapse or on Previous Treatment",TERMINATED,,PHASE2,2.0,ACTUAL,University of Lausanne Hospitals,,7.0,,Difficulties in recruiting patients due to changing in treatment standards for the target population,f,,,,t,f,f,,,,,,,,,,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2023,0.0
NCT03921294,,2019-03-29,2023-10-10,,2024-03-19,2019-04-16,2019-04-19,ACTUAL,2024-02-20,2024-03-20,ACTUAL,,,,2024-03-19,2024-04-11,ACTUAL,2019-05-15,ACTUAL,2019-05-15,2024-03,2024-03-31,2022-03-16,ACTUAL,2022-03-16,2022-03-16,ACTUAL,2022-03-16,,INTERVENTIONAL,,Patients with Factor VIII deficiency and hemophilia pseudotumor.,HemLibra Prophylaxis in Patients With Hemophilic Pseudotumor,"Prospective, Single-arm, Open-label Use of Hemlibra (Emicizumab) to Treat Hemophilic Pseudotumor",TERMINATED,,PHASE4,1.0,ACTUAL,"Indiana Hemophilia &Thrombosis Center, Inc.",,1.0,,Global COVID-19 pandemic prevented further study visits or enrollment.,f,,,,t,t,f,,,f,,,IPD and additional information on study methods will be made available starting 9 months after publication or conclusion of the study and ending 36 months following publication or study conclusion.,"IPD and study information will be shared with investigators whose proposed use of the data has been approved by an independent review committee (learned intermediary), whose proposals are methodologically sound, and for purposes that are consistent with the aims of the underlying research. Proposals will be reviewed by the Principle Investigator, Dr. Amy Shapiro, and may be submitted to ashapiro@ihtc.org. Requestors will be required to sign a data access and use agreement.",,YES,"We will share resources and data from this project through collaborative publications in the scientific literature as well as through national, regional and international conference presentations. We will also share our methods and findings in a prompt manner with regional, national and international stakeholders to ensure that findings will be readily available to other researchers and clinicians with clinical or scientific interest in the subject area. Individual participant data that underlie the results reports in publications, reports or presentations (including text, tables, figures and appendices) will be shared after de-identification.",2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2022,0.0
NCT04510285,,2020-08-10,2023-01-05,,2023-01-05,2020-08-10,2020-08-12,ACTUAL,2023-01-05,2023-02-01,ACTUAL,,,,2023-01-05,2023-02-01,ACTUAL,2020-08-10,ACTUAL,2020-08-10,2023-01,2023-01-31,2022-12-30,ACTUAL,2022-12-30,2022-12-30,ACTUAL,2022-12-30,,INTERVENTIONAL,,,A Single-Arm Pilot Study of Adjuvant Pembrolizumab Plus Trastuzumab in HER2+ Esophagogastric Tumors With Persistent Circulating Tumor DNA Following Curative Resection,A Single-Arm Pilot Study of Adjuvant Pembrolizumab Plus Trastuzumab in HER2+ Esophagogastric Tumors With Persistent Circulating Tumor DNA Following Curative Resection,TERMINATED,,PHASE2,1.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,Lack of accrual,f,,,,,t,f,,,,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2022,0.0
NCT04929626,,2021-05-10,,,2023-04-03,2021-06-16,2021-06-18,ACTUAL,,,,,,,2023-04-03,2023-04-05,ACTUAL,2022-01-01,ACTUAL,2022-01-01,2023-04,2023-04-30,2022-11-12,ACTUAL,2022-11-12,2022-11-12,ACTUAL,2022-11-12,,INTERVENTIONAL,,,Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus,Comparison of Doses of Nebulized Magnesium Sulphate as an Adjuvant Treatment With Salbutamol in Children With Status Asthmaticus,COMPLETED,,PHASE1,126.0,ACTUAL,Ziauddin University,,2.0,,,f,,,,,f,f,,,f,,,,,,NO,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2022,1.0
NCT03719898,,2018-10-16,,,2021-01-04,2018-10-24,2018-10-25,ACTUAL,,,,,,,2021-01-04,2021-01-05,ACTUAL,2018-12-06,ACTUAL,2018-12-06,2021-01,2021-01-31,2020-06-16,ACTUAL,2020-06-16,2020-03-18,ACTUAL,2020-03-18,,INTERVENTIONAL,,,Brigatinib in Relapsed or Refractory ALK-Positive Anaplastic Large Cell Lymphoma,A Phase II Study of Brigatinib in Relapsed or Refractory ALK-Positive Anaplastic Large Cell Lymphoma,WITHDRAWN,,PHASE2,0.0,ACTUAL,Fox Chase Cancer Center,,1.0,,Slow accrual,f,,,,t,t,f,,,f,,,,,,,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2020,0.0
NCT03363503,,2017-11-17,,,2022-05-16,2017-12-05,2017-12-06,ACTUAL,,,,,,,2022-05-16,2022-05-20,ACTUAL,2018-04-13,ACTUAL,2018-04-13,2022-05,2022-05-31,2022-04-13,ACTUAL,2022-04-13,2022-04-13,ACTUAL,2022-04-13,,INTERVENTIONAL,COPD,,Salmeterol/Fluticasone 50/500 mcg Inhalation Powder Via Capsair vs Seretide Diskus 500 mcg Inhalation Powder in Patients With COPD,Comparison of Efficacy and Safety of Salmeterol/Fluticasone 50/500 mcg Inhalation Powder Treatment Administered Via Capsair and Original Product Seretide Diskus 500 mcg Inhalation Powder Treatment in Patients With Moderate-severe Chronic Obstructive Pulmonary Disease (COPD),TERMINATED,,PHASE4,64.0,ACTUAL,Neutec Ar-Ge San ve Tic A.Ş,,2.0,,Adequate number of patients could not be reached in the relevant centers.,f,,,,f,f,f,,,,,,,,,,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,INDUSTRY,,,,,,,2022,0.0
NCT05146882,,2021-11-09,,,2024-09-11,2021-11-23,2021-12-07,ACTUAL,,,,,,,2024-09-11,2024-09-19,ACTUAL,2021-12,ESTIMATED,2021-12-31,2024-09,2024-09-30,2022-05-23,ACTUAL,2022-05-23,2022-05-23,ACTUAL,2022-05-23,,INTERVENTIONAL,,,An Extension Study of Belcesiran in Patients With Alpha-1 Antitrypsin Deficiency Associated Liver Disease (AATLD),A Phase 2 Open-Label Extension Study to Evaluate the Safety and Pharmacodynamics of Belcesiran in Patients With PiZZ Alpha-1 Antitrypsin Deficiency Associated Liver Disease,WITHDRAWN,,PHASE2,0.0,ACTUAL,Novo Nordisk A/S,,2.0,,Update to Program Design - No Participants Enrolled,f,,,,t,f,f,,,,,,,,,,,2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,INDUSTRY,,,,,,,2022,0.0
NCT04372017,,2020-04-25,2021-12-06,,2021-12-08,2020-04-30,2020-05-01,ACTUAL,2021-12-08,2021-12-10,ACTUAL,,,,2021-12-08,2021-12-10,ACTUAL,2020-05-14,ACTUAL,2020-05-14,2021-12,2021-12-31,2021-06-04,ACTUAL,2021-06-04,2021-06-04,ACTUAL,2021-06-04,,INTERVENTIONAL,,No subjects or data analyzed. Study was closed to enrollment before analysis.,Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection,"Randomized, Double-Blind, Controlled Trial of Hydroxychloroquine vs Placebo as Post-Exposure Prophylaxis Against COVID-19 Infection",TERMINATED,,PHASE3,1.0,ACTUAL,Sanford Health,,4.0,,Unlikelihood of benefit based on other studies.,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,OTHER,,,,,,,2021,0.0
NCT03233724,,2017-07-28,2023-03-15,,2023-05-04,2017-07-28,2017-07-31,ACTUAL,2023-05-04,2023-05-31,ACTUAL,,,,2023-05-04,2023-05-31,ACTUAL,2018-04-11,ACTUAL,2018-04-11,2023-05,2023-05-31,2021-10-26,ACTUAL,2021-10-26,2021-10-06,ACTUAL,2021-10-06,,INTERVENTIONAL,,"No participants were enrolled on Decitabine 0.17mg/kg + Tetrahydrouridine 10mg/kg Every (q) Tuesday,Wednesday (TW) x 2 Weeks q3Weeks.","Oral Decitabine and Tetrahydrouridine as Epigenetic Priming for Pembrolizumab-Mediated Immune Checkpoint Blockade in Patients With Inoperable, or Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancers and Esophageal Carcinomas","Phase I/II Evaluation of Oral Decitabine/Tetrahydrouridine as Epigenetic Priming for Pembrolizumab Immune Checkpoint Blockade in Inoperable Locally Advanced or Metastatic Non-Small Cell Lung Cancers, Esophageal Carcinomas, or Pleural Mesotheliomas",TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,National Institutes of Health Clinical Center (CC),,2.0,,Study terminated due to drug supply issues.,f,,,,f,t,f,,,,,,Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.,Clinical data will be made available via subscription to the Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.,,YES,"All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the Database of Genotypes and Phenotypes (dbGaP).",2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,NIH,,,,,,,2021,0.0
NCT01887522,,2013-06-19,,,2022-05-24,2013-06-24,2013-06-27,ESTIMATED,,,,,,,2022-05-24,2022-05-31,ACTUAL,2016-07-06,ACTUAL,2016-07-06,2022-05,2022-05-31,2021-04-25,ACTUAL,2021-04-25,2019-04-20,ACTUAL,2019-04-20,,INTERVENTIONAL,VINILO,,"Study of Vinblastine in Combination With Nilotinib in Children, Adolescents, and Young Adults","Phase I-II Study of Vinblastine in Combination With Nilotinib in Children, Adolescents, and Young Adults With Refractory or Recurrent Low-Grade Glioma",TERMINATED,,PHASE2,144.0,ACTUAL,"Gustave Roussy, Cancer Campus, Grand Paris",,2.0,,the results of the interim analysis are clear with a significant advantage in terms of PFS in favor of the control arm (Vinblastine alone) over the investigational arm (Vinblastine + Nilotinib).,f,,,,f,,,,,,,,,,,,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2021,0.0
NCT05376319,,2022-05-11,2024-07-09,,2024-07-09,2022-05-11,2022-05-17,ACTUAL,2024-07-09,2024-07-31,ACTUAL,,,,2024-07-09,2024-07-31,ACTUAL,2023-06-30,ACTUAL,2023-06-30,2024-07,2024-07-31,2024-05-07,ACTUAL,2024-05-07,2024-05-07,ACTUAL,2024-05-07,,INTERVENTIONAL,,,PR3-AAV Resilient Remission or PRRR,"A Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Effect of Obinutuzumab Versus Rituximab in PR3-Patients With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis",TERMINATED,,PHASE2,6.0,ACTUAL,Mayo Clinic,Study was discontinued early due to funding termination by industry sponsor.,2.0,,Funding was withdrawn by sponsor.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2024,0.0
NCT02099864,,2014-03-26,2020-10-01,,2024-09-05,2014-03-26,2014-03-31,ESTIMATED,2020-12-18,2021-01-13,ACTUAL,,,,2024-09-05,2024-09-19,ACTUAL,2014-02-05,ACTUAL,2014-02-05,2024-09,2024-09-30,2024-07-08,ACTUAL,2024-07-08,2019-10-01,ACTUAL,2019-10-01,,INTERVENTIONAL,,,Genetic and Molecular Mechanisms in Assessing Response in Patients With Prostate Cancer Receiving Enzalutamide Therapy,Molecular Mechanisms Underlying Tumor Progression Despite Enzalutamide Treatment,COMPLETED,,PHASE2,36.0,ACTUAL,OHSU Knight Cancer Institute,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,OTHER,,,,,,,2024,1.0
NCT03043547,,2017-01-26,,,2022-05-17,2017-02-02,2017-02-06,ESTIMATED,,,,,,,2022-05-17,2022-05-18,ACTUAL,2017-10-24,ACTUAL,2017-10-24,2022-05,2022-05-31,2022-03-08,ACTUAL,2022-03-08,2021-12-08,ACTUAL,2021-12-08,,INTERVENTIONAL,NALIRICC,,Nal-IRI and 5-FU Compared to 5-FU in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies,A Randomized Phase II Trial of Nal-IRI and 5-Fluorouracil Compared to 5-Fluorouracil in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies,COMPLETED,,PHASE2,100.0,ACTUAL,AIO-Studien-gGmbH,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2022,0.0
NCT06056596,,2023-08-01,,,2024-09-10,2023-09-20,2023-09-28,ACTUAL,,,,,,,2024-09-10,2024-09-19,ACTUAL,2024-01-30,ACTUAL,2024-01-30,2024-09,2024-09-30,2024-09-06,ACTUAL,2024-09-06,2024-09-06,ACTUAL,2024-09-06,,INTERVENTIONAL,,,Lamivudine and Plasma Markers of Inflammation in Retinal Detachment,Intra-ocular Penetration of Oral Lamivudine and Measurement of Systemic Inflammatory Markers in Patients Undergoing Rhegmatogenous Retinal Detachment Surgery,TERMINATED,,EARLY_PHASE1,2.0,ACTUAL,"University of Wisconsin, Madison",,2.0,,"Treatment approach changed, and insufficient population",f,,,,f,t,f,,,t,,,,,,YES,,2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,OTHER,,,,,,,2024,0.0
NCT01967238,,2013-10-17,2023-07-27,,2024-04-23,2013-10-17,2013-10-22,ESTIMATED,2024-04-23,2024-09-19,ACTUAL,,,,2024-04-23,2024-09-19,ACTUAL,2013-03,ACTUAL,2013-03-31,2024-04,2024-04-30,2023-03,ACTUAL,2023-03-31,2023-03,ACTUAL,2023-03-31,,INTERVENTIONAL,,,An Open Label Study of IgG Fc Glycan Composition in Human Immunity,An Open Label Study of IgG Fc Glycan Composition in Human Immunity,TERMINATED,,EARLY_PHASE1,129.0,ACTUAL,Rockefeller University,,3.0,,Inadequate enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,OTHER,,,,,,,2023,0.0
NCT05183360,,2021-12-20,,,2024-09-18,2021-12-22,2022-01-10,ACTUAL,,,,,,,2024-09-18,2024-09-19,ACTUAL,2022-02-03,ACTUAL,2022-02-03,2024-09,2024-09-30,2024-08-08,ACTUAL,2024-08-08,2022-08-22,ACTUAL,2022-08-22,,INTERVENTIONAL,,,A Study in Healthy Japanese and Chinese Men to Test How Well Different Doses of BI 706321 Are Tolerated,"Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Dose and Multiple Rising Oral Doses of BI 706321 in Healthy Japanese Male Subjects and Single Oral Dose of BI 706321 in Healthy Chinese Male Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design)",TERMINATED,,PHASE1,60.0,ACTUAL,Boehringer Ingelheim,,3.0,,Company decision,f,,,,f,f,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,INDUSTRY,,,,,,,2024,0.0
NCT02618577,,2015-11-27,,,2023-07-27,2015-11-27,2015-12-01,ESTIMATED,,,,,,,2023-07-27,2023-07-28,ACTUAL,2016-02,ACTUAL,2016-02-29,2023-07,2023-07-31,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,NOAH,,Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes,"Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes - An Investigator-driven, Prospective, Randomised, Double-blind, Multi-centre Trial Initiated by the European Society of Cardiology and AFNET",TERMINATED,,PHASE3,2608.0,ACTUAL,Atrial Fibrillation Network,,2.0,,following a recommendation from the data safety and monitoring board due to safety concerns and a tendency towards futility.,f,,,,t,,,,,,,,,,,,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2022,0.0
NCT04605094,,2020-09-01,2023-04-21,,2023-08-30,2020-10-21,2020-10-27,ACTUAL,2023-06-06,2023-06-27,ACTUAL,,,,2023-08-30,2023-08-31,ACTUAL,2020-11-12,ACTUAL,2020-11-12,2023-08,2023-08-31,2022-09-13,ACTUAL,2022-09-13,2022-04-25,ACTUAL,2022-04-25,,INTERVENTIONAL,,"The Full Analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study.",Efficacy and Safety Study of the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis,"A Phase 2 Multinational, Randomized, Double-blind, Parallel-group, 16-week Placebo-controlled Study With a 36-Week Extension to Investigate the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis Despite Treatment With Topical Medications (The HILLIER Study)",TERMINATED,,PHASE2,194.0,ACTUAL,AstraZeneca,The study was terminated as the study did not support the continued development of benralizumab for the indication of AD.,2.0,,The study did not meet the primary endpoint.,f,,,,,t,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,INDUSTRY,,,,,,,2022,0.0
NCT02582775,,2015-10-16,2024-01-29,,2024-08-19,2015-10-19,2015-10-21,ESTIMATED,2024-08-19,2024-09-19,ACTUAL,,,,2024-08-19,2024-09-19,ACTUAL,2016-03,ACTUAL,2016-03-31,2024-08,2024-08-31,2023-07-26,ACTUAL,2023-07-26,2022-11-15,ACTUAL,2022-11-15,,INTERVENTIONAL,,,MT2015-20: Biochemical Correction of Severe EB by Allo HSCT and Serial Donor MSCs,MT2015-20: Biochemical Correction of Severe Epidermolysis Bullosa by Allogeneic Cell Transplantation and Serial Donor Mesenchymal Cell Infusions,COMPLETED,,PHASE2,17.0,ACTUAL,"Masonic Cancer Center, University of Minnesota",,8.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,OTHER,,,,,,,2023,1.0
NCT04349917,,2020-04-13,2020-09-16,,2020-12-16,2020-04-13,2020-04-16,ACTUAL,2020-12-16,2021-01-12,ACTUAL,,,,2020-12-16,2021-01-12,ACTUAL,2016-12-16,ACTUAL,2016-12-16,2020-04,2020-04-30,2020-03-14,ACTUAL,2020-03-14,2020-03-14,ACTUAL,2020-03-14,,INTERVENTIONAL,,,Large-scale Brain Organization During Cognitive Control in ADHD,Large-scale Brain Organization During Cognitive Control in ADHD,COMPLETED,,PHASE4,37.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2020,1.0
NCT03199547,,2017-06-23,,,2022-03-15,2017-06-23,2017-06-27,ACTUAL,,,,,,,2022-03-15,2022-03-31,ACTUAL,2017-10-21,ACTUAL,2017-10-21,2022-03,2022-03-31,2021-05-31,ACTUAL,2021-05-31,2021-05-31,ACTUAL,2021-05-31,,INTERVENTIONAL,PregnAnZI-2,,Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death,Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis and Death: a Phase III Double-blind Randomized Clinical Trial,COMPLETED,,PHASE3,11985.0,ACTUAL,London School of Hygiene and Tropical Medicine,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2021,0.0
NCT05375604,,2022-05-11,,,2023-05-30,2022-05-11,2022-05-16,ACTUAL,,,,,,,2023-05-30,2023-06-01,ACTUAL,2022-06-28,ACTUAL,2022-06-28,2023-05,2023-05-31,2023-05-30,ACTUAL,2023-05-30,2023-05-25,ACTUAL,2023-05-25,,INTERVENTIONAL,,,A Study of exoASO-STAT6 (CDK-004) in Patients With Advanced Hepatocellular Carcinoma (HCC) and Patients With Liver Metastases From EIther Primary Gastric Cancer or Colorectal Cancer (CRC),"Phase 1 Study of Macrophage Reprogramming Agent, exoASO-STAT6 (CDK-004), in Patients With Advanced Hepatocellular Carcinoma (HCC) and Patients With Liver Metastases From Either Primary Gastric Cancer or Colorectal Cancer (CRC)",TERMINATED,,PHASE1,9.0,ACTUAL,Codiak BioSciences,,1.0,,Company Bankruptcy,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,INDUSTRY,,,,,,,2023,0.0
NCT04973449,,2021-07-02,2023-02-03,,2024-05-01,2021-07-21,2021-07-22,ACTUAL,2024-05-01,2024-09-19,ACTUAL,,,,2024-05-01,2024-09-19,ACTUAL,2021-06-27,ACTUAL,2021-06-27,2024-04,2024-04-30,2022-08-02,ACTUAL,2022-08-02,2022-02-04,ACTUAL,2022-02-04,,INTERVENTIONAL,AZD2816,"Full analysis set included all randomised participants who received study treatment, irrespective of their protocol adherence and continued participation in the study. Participants were analysed according to their randomised treatment assignment, irrespective of the treatment actually received.","Phase II/III Study of AZD2816, for the Prevention of COVID-19 in Adults","A Phase II/III Partially Double-Blinded, Randomised, Multinational, Active-Controlled Study in Both Previously Vaccinated and Unvaccinated Adults to Determine the Safety and Immunogenicity of AZD2816, a Vaccine for the Prevention of COVID-19 Caused by Variant Strains of SARS-CoV-2",COMPLETED,,PHASE2/PHASE3,2843.0,ACTUAL,AstraZeneca,"Since different assays were used between strains and also within the same strains between this study and historical control study D8110C00001 (NCT04516746), spike protein binding antibody results were summarised descriptively; no comparative analyses were conducted.",8.0,,,f,,,,t,f,f,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure","When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure~URL:~https://astrazenecagroup-dt.pharmacm.com/DT/Home",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure,2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,INDUSTRY,,,,,,,2022,1.0
NCT05048134,,2021-08-31,,,2024-09-17,2021-09-09,2021-09-17,ACTUAL,,,,,,,2024-09-17,2024-09-19,ACTUAL,2021-10-25,ACTUAL,2021-10-25,2024-09,2024-09-30,2023-05-23,ACTUAL,2023-05-23,2023-02-24,ACTUAL,2023-02-24,,INTERVENTIONAL,,,A Phase I Study of HRS2300 or Combined With SHR-1316 or SHR-1701 or Trametinib or Almonertinib in Patients With Advanced Malignancies,"A Multi-center, Open-Label，Dose Escalation and Dose Expansion Phase I Study of HRS2300 Monotherapy or Combined With SHR-1316 or SHR-1701 or Trametinib or Almonertinib in Patients With Advanced Malignancies",TERMINATED,,PHASE1,13.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,5.0,,Sponsor R\&D strategy adjustment,f,,,,,f,f,,,,,,,,,UNDECIDED,,2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,INDUSTRY,,,,,,,2023,0.0
NCT03107780,,2017-04-10,,,2024-09-13,2017-04-10,2017-04-11,ACTUAL,,,,,,,2024-09-13,2024-09-19,ACTUAL,2018-07-09,ACTUAL,2018-07-09,2024-08,2024-08-31,2024-12-31,ESTIMATED,2024-12-31,2024-12-31,ESTIMATED,2024-12-31,,INTERVENTIONAL,,,Testing the Ability of AMG 232 (KRT 232) to Get Into the Tumor in Patients With Brain Cancer,Phase 0/I Study of AMG 232 (KRT 232) Concentrations in Brain Tissue in Patients With Recurrent Glioblastoma and of AMG 232 (KRT 232) in Combination With Radiation in Patients With Newly Diagnosed Glioblastoma and Unmethylated MGMT Promoters,SUSPENDED,,PHASE1,86.0,ESTIMATED,National Cancer Institute (NCI),,1.0,,Other - Aministrative hold,f,,,,f,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page",2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,NIH,,,,,,,2024,0.0
NCT04080505,,2019-09-04,2024-08-08,,2024-09-03,2019-09-04,2019-09-06,ACTUAL,2024-09-03,2024-09-19,ACTUAL,,,,2024-09-03,2024-09-19,ACTUAL,2015-02-10,ACTUAL,2015-02-10,2024-09,2024-09-30,2023-03-03,ACTUAL,2023-03-03,2023-03-03,ACTUAL,2023-03-03,,INTERVENTIONAL,,,Does Potassium Iodide (SSKI) Reduce Vascularity in Graves' Thyroidectomy?,Does the Use of Pre-operative SSKI Actually Reduce Vascularity and Improve Surgical Outcomes for Total Thyroidectomy in Graves' Disease?,TERMINATED,,PHASE3,29.0,ACTUAL,Columbia University,,2.0,,Low enrollment,f,,,,f,t,f,,,,,,,,,,,2024-10-15 04:00:26.31362,2024-10-15 04:00:26.31362,OTHER,,,,,,,2023,0.0
NCT02255097,,2014-09-30,2017-04-20,,2022-06-23,2014-09-30,2014-10-02,ESTIMATED,2017-06-07,2017-07-06,ACTUAL,,,,2022-06-23,2022-06-28,ACTUAL,2014-10-24,ACTUAL,2014-10-24,2022-06,2022-06-30,2021-06-18,ACTUAL,2021-06-18,2016-04-22,ACTUAL,2016-04-22,,INTERVENTIONAL,,The baseline population included all participants allocated to receive ≥1 dose of pembrolizumab.,Study of MK-3475 (Pembrolizumab) in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Treatment With Platinum-based and Cetuximab Therapy (MK-3475-055/KEYNOTE-055),A Phase II Clinical Trial of Single Agent Pembrolizumab (MK-3475) in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Who Have Failed Platinum and Cetuximab,COMPLETED,,PHASE2,172.0,ACTUAL,Merck Sharp & Dohme LLC,,1.0,,,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,INDUSTRY,,,,,,,2021,1.0
NCT04163016,,2019-10-24,2024-04-24,,2024-04-24,2019-11-13,2019-11-14,ACTUAL,2024-04-24,2024-09-19,ACTUAL,,,,2024-04-24,2024-09-19,ACTUAL,2020-06-19,ACTUAL,2020-06-19,2024-04,2024-04-30,2023-05-23,ACTUAL,2023-05-23,2023-05-23,ACTUAL,2023-05-23,,INTERVENTIONAL,CHERISH,"Baseline Characteristics refer to the Enrolled Set (ES) which consisted of all study participants who were confirmed as having signed the Informed Consent Form (ICF) to participate in the study and had provided the first blood sample. Due to data protection/data privacy, data cannot be reported for a single participant enrolled in 'Not Dosed' and 'CZP 400 mg Q2W' arms.",A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol),"A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)",COMPLETED,,PHASE1,22.0,ACTUAL,UCB Pharma,,1.0,,,f,,,,f,t,f,,,f,,,,,,NO,"Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.",2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,INDUSTRY,,,,,,,2023,1.0
NCT05838703,,2023-03-24,,,2023-06-13,2023-04-20,2023-05-01,ACTUAL,,,,,,,2023-06-13,2023-06-15,ACTUAL,2023-05-01,ESTIMATED,2023-05-01,2023-06,2023-06-30,2024-05-01,ESTIMATED,2024-05-01,2024-05-01,ESTIMATED,2024-05-01,,INTERVENTIONAL,,,Tiotropium Handihaler vs. Tiotropium Respimat in COPD,Comparing the Acute Effects of Tiotropium Handihaler With Tiotropium Respimat on the Ventilation Distribution in COPD Patients,WITHDRAWN,,PHASE2,0.0,ACTUAL,Duke University,,2.0,,"Study halted prematurely due to funding, prior to enrollment of first participant",f,,,,,t,f,,,,,,,,,,,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,OTHER,,,,,,,2024,0.0
NCT04405570,,2020-05-26,2022-01-18,,2022-02-14,2020-05-26,2020-05-28,ACTUAL,2022-02-14,2022-02-16,ACTUAL,,,,2022-02-14,2022-02-16,ACTUAL,2020-06-19,ACTUAL,2020-06-19,2022-02,2022-02-28,2021-02-21,ACTUAL,2021-02-21,2021-02-21,ACTUAL,2021-02-21,,INTERVENTIONAL,,,"Safety, Tolerability and Efficacy of Molnupiravir (EIDD-2801) to Eliminate Infectious Virus Detection in Persons With COVID-19","A Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability and Efficacy of EIDD-2801 to Eliminate SARS-CoV-2RNA Detection in Persons With COVID-19",COMPLETED,,PHASE2,204.0,ACTUAL,"Ridgeback Biotherapeutics, LP",,4.0,,,f,,,,,t,f,,,,,,,,,NO,There is not a plan to make IPD available.,2024-10-16 15:24:16.357403,2024-10-16 15:24:16.357403,INDUSTRY,,,,,,,2021,1.0
NCT02419495,,2015-04-14,,,2024-09-17,2015-04-16,2015-04-17,ESTIMATED,,,,,,,2024-09-17,2024-09-19,ACTUAL,2015-06-26,ACTUAL,2015-06-26,2024-09,2024-09-30,2024-09-16,ACTUAL,2024-09-16,2024-09-16,ACTUAL,2024-09-16,,INTERVENTIONAL,,,Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination with Multiple Standard Chemotherapy or Immunotherapy Agents in Patients with Advanced Malignancies,Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination with Multiple Standard Chemotherapy or Immunotherapy Agents in Patients with Advanced Malignancies,TERMINATED,,PHASE1,221.0,ACTUAL,M.D. Anderson Cancer Center,,15.0,,Administratively Complete,f,,,,f,t,f,,,f,,,,,,,,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,OTHER,,,,,,,2024,0.0
NCT05695378,,2022-12-22,,,2024-09-12,2023-01-12,2023-01-25,ACTUAL,,,,,,,2024-09-12,2024-09-19,ACTUAL,2023-02-27,ACTUAL,2023-02-27,2024-09,2024-09-30,2024-08-19,ACTUAL,2024-08-19,2024-08-19,ACTUAL,2024-08-19,,INTERVENTIONAL,,,Trial to Evaluate the Efficacy and Safety of KM-819 Treatment to Slow the Progression of Multiple System Atrophy (MSA),"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of KM-819 Treatment to Slow the Progression of Multiple System Atrophy",TERMINATED,,PHASE2,68.0,ACTUAL,Kainos Medicine Inc.,,3.0,,Sponsor has decided to withdraw the study due to safety issue and re-initiate with a new clinical study,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,INDUSTRY,,,,,,,2024,0.0
NCT03606174,,2018-07-20,2023-08-03,,2023-08-03,2018-07-20,2018-07-30,ACTUAL,2023-08-03,2023-08-24,ACTUAL,,,,2023-08-03,2023-08-24,ACTUAL,2018-09-11,ACTUAL,2018-09-11,2023-08,2023-08-31,2022-08-22,ACTUAL,2022-08-22,2022-08-03,ACTUAL,2022-08-03,,INTERVENTIONAL,,"Measured in the safety population, which included all participants who received ≥ 1 dose of any study treatment (sitravatinib, nivolumab, pembrolizumab, or enfortumab vedotin).",A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma,A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma,TERMINATED,,PHASE2,260.0,ACTUAL,Mirati Therapeutics Inc.,,9.0,,"The study was terminated due to sponsor decision / portfolio prioritization, and not due to safety reasons.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,INDUSTRY,,,,,,,2022,0.0
NCT04661579,,2020-10-26,2023-06-30,,2024-01-19,2020-12-03,2020-12-10,ACTUAL,2024-01-19,2024-07-19,ACTUAL,,,,2024-01-19,2024-07-19,ACTUAL,2020-11-06,ACTUAL,2020-11-06,2024-01,2024-01-31,2022-08-17,ACTUAL,2022-08-17,2022-06-22,ACTUAL,2022-06-22,,INTERVENTIONAL,,The total vaccinated cohort (TVC) includes all randomized participants who received at least one vaccination.,"Study of Malaria Vaccine RTS,S/AS01E in Plasmodium Falciparum-infected and Uninfected Adults Pre-treated With Anti-malarial Therapy","A Phase 2b Randomized, Open-label, Controlled, Single Center Study in Plasmodium Falciparum-infected and Uninfected Adults Age 18-55 Years Old in Kenya to Evaluate the Efficacy of the Delayed, Fractional Dose RTS,S/AS01E Malaria Vaccine in Subjects Treated With Artemisinin Combination Therapy Plus Primaquine",COMPLETED,,PHASE2,620.0,ACTUAL,PATH,,5.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,OTHER,,,,,,,2022,1.0
NCT01433497,,2011-09-12,,2020-03-30,2020-04-03,2011-09-13,2011-09-14,ESTIMATED,,,,2020-03-30,2020-04-03,ACTUAL,2020-04-03,2020-04-08,ACTUAL,2011-08,ACTUAL,2011-08-31,2020-04,2020-04-30,2020-02,ACTUAL,2020-02-29,2019-09,ACTUAL,2019-09-30,,INTERVENTIONAL,,,Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis,"A 96 Week, Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled, 2 Parallel-groups, Phase 3 Study to Compare Efficacy and Safety of Masitinib 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis",COMPLETED,,PHASE3,656.0,ACTUAL,AB Science,,4.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,INDUSTRY,,,,,,,2020,1.0
NCT04411641,,2020-05-28,,,2024-09-13,2020-05-28,2020-06-02,ACTUAL,,,,,,,2024-09-13,2024-09-19,ACTUAL,2020-09-24,ACTUAL,2020-09-24,2024-09,2024-09-30,2024-08-29,ACTUAL,2024-08-29,2024-08-29,ACTUAL,2024-08-29,,INTERVENTIONAL,HERCULES,,Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES),"A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis",COMPLETED,,PHASE3,1131.0,ACTUAL,Sanofi,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,INDUSTRY,,,,,,,2024,1.0
NCT03877692,,2019-03-11,,,2020-07-20,2019-03-14,2019-03-18,ACTUAL,,,,,,,2020-07-20,2020-07-22,ACTUAL,2019-02-18,ACTUAL,2019-02-18,2020-07,2020-07-31,2020-07-20,ACTUAL,2020-07-20,2020-07-20,ACTUAL,2020-07-20,,INTERVENTIONAL,ACCTIVE,,Acute Control of Chronic Hypertension,Acute Control of Chronic Hypertension in Preeclampsia,TERMINATED,,PHASE4,10.0,ACTUAL,Albany Medical College,,2.0,,Slow enrollment,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,OTHER,,,,,,,2020,0.0
NCT03038009,,2017-01-29,,,2019-04-05,2017-01-29,2017-01-31,ESTIMATED,,,,,,,2019-04-05,2019-04-09,ACTUAL,2018-10,ESTIMATED,2018-10-31,2019-04,2019-04-30,2020-12,ESTIMATED,2020-12-31,2020-09,ESTIMATED,2020-09-30,,INTERVENTIONAL,DACAB-GI-2,,Proton Pump Inhibitor Prevent Dual Antiplatelet Agents Induced Gastrointestinal Ulcer After Coronary Artery Bypass Graft,Evaluation of the Efficacy and Safety of Different Duration of Proton Pump Inhibitor for Prevention of Upper Gastrointestinal Mucosal Injury in Patients Taking 12-month Dual Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery,WITHDRAWN,,PHASE4,0.0,ACTUAL,Ruijin Hospital,,2.0,,A new registration has been submitted due to a redesign of the study protocol.,f,,,,,f,f,,,,,,,,,NO,,2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,OTHER,,,,,,,2020,0.0
NCT04093505,,2018-10-30,,,2022-06-27,2019-09-16,2019-09-18,ACTUAL,,,,,,,2022-06-27,2022-07-01,ACTUAL,2021-04-01,ACTUAL,2021-04-01,2022-06,2022-06-30,2022-06-23,ACTUAL,2022-06-23,2022-06-15,ACTUAL,2022-06-15,,INTERVENTIONAL,GnG,,Gemtuzumab Ozogamicin in Induction and Glasdegib in Postremission Therapy in Patients With AML (Acute Myeloid Leukemia),Randomized Phase-III Study to Compare Two Schedules of Gemtuzumab Ozogamicin as Adjunct to Intensive Induction Therapy and to Compare Intensive Postremission Therapy Double Blinded With or Without Glasdegib in Older Patients With Newly Diagnosed AML,TERMINATED,,PHASE3,28.0,ACTUAL,University Hospital Heidelberg,,4.0,,Study turned out no longer feasible. End of Recruitment: 25.5.2022,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,OTHER,,,,,,,2022,0.0
NCT06276556,,2024-02-12,,,2024-09-12,2024-02-21,2024-02-26,ACTUAL,,,,,,,2024-09-12,2024-09-19,ACTUAL,2024-04-22,ACTUAL,2024-04-22,2024-08,2024-08-31,2024-09-05,ACTUAL,2024-09-05,2024-09-05,ACTUAL,2024-09-05,,INTERVENTIONAL,,,Extension Study of ABP-671 in Participants With Gout,"A Multicenter, Double-blind, Phase 2b/3 Extension Study to Assess the Safety and Efficacy of ABP-671 in Participants With Gout Who Completed the Double-blind Treatment Period in Study ABP-671-301",TERMINATED,,PHASE2/PHASE3,43.0,ACTUAL,"Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.",,2.0,,Redesign of clinical development program for ABP-671: A new long-term safety study after the completion and analysis of Part 1 of ABP-671-301 (NCT05818085) is planned and will be conducted using the doses selected for the pivotal studies.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,INDUSTRY,,,,,,,2024,0.0
NCT04410978,,2020-05-28,,,2024-09-13,2020-05-28,2020-06-01,ACTUAL,,,,,,,2024-09-13,2024-09-19,ACTUAL,2020-06-30,ACTUAL,2020-06-30,2024-09,2024-09-30,2024-07-15,ACTUAL,2024-07-15,2024-07-15,ACTUAL,2024-07-15,,INTERVENTIONAL,GEMINI 1,,Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1),"A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis",COMPLETED,,PHASE3,974.0,ACTUAL,Sanofi,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,INDUSTRY,,,,,,,2024,1.0
NCT03598036,,2018-06-14,2021-05-17,,2021-08-20,2018-07-24,2018-07-26,ACTUAL,2021-08-20,2021-09-16,ACTUAL,,,,2021-08-20,2021-09-16,ACTUAL,2018-06-21,ACTUAL,2018-06-21,2020-06,2020-06-30,2020-05-19,ACTUAL,2020-05-19,2020-05-19,ACTUAL,2020-05-19,,INTERVENTIONAL,AURONA™,Trial ended prematurely before any patients were enrolled into Cohort 2,Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis,An Open-Label Dose-Exploration Cohort Study Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects With Focal Segmental Glomerulosclerosis,TERMINATED,,PHASE2,5.0,ACTUAL,Aurinia Pharmaceuticals Inc.,"Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial.",1.0,,Low recruitment rate,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,INDUSTRY,,,,,,,2020,0.0
NCT04327700,,2020-03-26,,,2024-09-16,2020-03-30,2020-03-31,ACTUAL,,,,,,,2024-09-16,2024-09-19,ACTUAL,2021-01-26,ACTUAL,2021-01-26,2024-09,2024-09-30,2024-05-31,ACTUAL,2024-05-31,2024-05-31,ACTUAL,2024-05-31,,INTERVENTIONAL,,,Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib,A Phase II Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib as Second-line Therapy For Patients With Advanced Hepatocellular Carcinoma.,TERMINATED,,PHASE2,2.0,ACTUAL,Wake Forest University Health Sciences,,1.0,,Slow accruals,f,,,,t,t,t,,,,,,,,,NO,,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,OTHER,,,,,,,2024,0.0
NCT05655299,,2022-12-02,,2024-09-12,2024-09-12,2022-12-08,2022-12-19,ACTUAL,,,,,2023-12-28,ACTUAL,2024-09-12,2024-09-19,ACTUAL,2022-11-17,ACTUAL,2022-11-17,2024-09,2024-09-30,2023-12-20,ACTUAL,2023-12-20,2023-09-25,ACTUAL,2023-09-25,,INTERVENTIONAL,Serenity PsO,,VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis,"A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Participants With Moderate to Severe Psoriasis",TERMINATED,,PHASE2,222.0,ACTUAL,"Ventyx Biosciences, Inc",,5.0,,Business Decision,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,INDUSTRY,,,,,,,2023,0.0
NCT04335305,,2020-03-31,,,2022-06-14,2020-04-02,2020-04-06,ACTUAL,,,,,,,2022-06-14,2022-06-21,ACTUAL,2020-04-09,ACTUAL,2020-04-09,2022-06,2022-06-30,2021-06-21,ACTUAL,2021-06-21,2021-03-08,ACTUAL,2021-03-08,,INTERVENTIONAL,COPERNICO,,Checkpoint Blockade in COVID-19 Pandemic,"A Randomized, Controlled, Open-Label, Phase II Trial to Evaluate the Efficacy and Safety of Tocilizumab Combined With Pembrolizumab (MK-3475) in Patients With Coronavirus Disease 2019 (COVID-19)-Pneumonia",TERMINATED,,PHASE2,12.0,ACTUAL,MedSIR,,2.0,,Recruitment issues,f,,,,f,f,f,,,,,,,,,,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,OTHER,,,,,,,2021,0.0
NCT03747562,,2018-10-09,,,2024-09-05,2018-11-19,2018-11-20,ACTUAL,,,,,,,2024-09-05,2024-09-19,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2024-09,2024-09-30,2022-07-01,ACTUAL,2022-07-01,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,stREnGTH,,Study of Efficacy and Safety of Gabapentin to Reduce the Need for Strong Opioid Use in Head and Neck Cancer Patients.,"Multi-centre, Double-blind, Randomized-controlled Trial to Study the Efficacy and Safety of Gabapentin to Reduce Strong Opioid Use in Treatment of Radiation-induced Pain in Head and Neck Cancer Patients During Curative Radio(chemo)therapy.",WITHDRAWN,,PHASE3,0.0,ACTUAL,"University Hospital, Ghent",,2.0,,Lack of funding,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,OTHER,,,,,,,2022,0.0
NCT03735875,,2018-11-02,2024-07-24,,2024-08-26,2018-11-07,2018-11-08,ACTUAL,2024-08-26,2024-09-19,ACTUAL,,,,2024-08-26,2024-09-19,ACTUAL,2019-01-25,ACTUAL,2019-01-25,2024-08,2024-08-31,2023-07-26,ACTUAL,2023-07-26,2023-07-26,ACTUAL,2023-07-26,,INTERVENTIONAL,,This study did not move on to the Phase II portion of the study.,Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia,A Phase Ib/II Study of Venetoclax in Combination With Quizartinib in FLT3-Mutated Acute Myelogenous Leukemia (AML),TERMINATED,,PHASE1/PHASE2,8.0,ACTUAL,M.D. Anderson Cancer Center,"This study was terminated early due to competing trials. All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. This study did not move on to the Phase II portion of the study. Therefore, no patients were accrued on the Phase II portion of the study.",2.0,,"This study was terminated early due to other competing trials, therefore did not go on to the Phase II portion of the study.",,,,,f,t,f,,,,,,,,,,,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,OTHER,,,,,,,2023,0.0
NCT06064279,,2023-09-01,,,2024-09-12,2023-09-28,2023-10-03,ACTUAL,,,,,,,2024-09-12,2024-09-19,ACTUAL,2024-06-04,ACTUAL,2024-06-04,2024-09,2024-09-30,2024-06-04,ACTUAL,2024-06-04,2024-06-04,ACTUAL,2024-06-04,,INTERVENTIONAL,HAITEN-ICI,,Harnessing Allo-immunity to Enhance Immune Checkpoint Inhibitor Responses in Advanced NSCLC,Harnessing Allo-immunity to Enhance Immune Checkpoint Inhibitor Responses in Advanced NSCLC,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,VA Office of Research and Development,,1.0,,The funding for this trial was removed.,f,,,,f,t,f,,,f,,,,,,YES,,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,FED,,,,,,,2024,0.0
NCT05523089,,2022-08-29,2024-07-16,,2024-09-04,2022-08-29,2022-08-31,ACTUAL,2024-08-12,2024-09-05,ACTUAL,,,,2024-09-04,2024-09-19,ACTUAL,2022-09-09,ACTUAL,2022-09-09,2024-09,2024-09-30,2023-07-17,ACTUAL,2023-07-17,2023-07-17,ACTUAL,2023-07-17,,INTERVENTIONAL,,The Safety Population included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they received.,The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults,"A Proof-of-concept, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Assess the Prophylactic Antiviral Activity Against Influenza, Safety, Tolerability, and Pharmacokinetics of CD388 Via a Human Viral Challenge Model",COMPLETED,,PHASE2,59.0,ACTUAL,Cidara Therapeutics Inc.,,6.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,INDUSTRY,,,,,,,2023,1.0
NCT05717400,,2023-01-27,,,2024-09-03,2023-01-27,2023-02-08,ACTUAL,,,,,,,2024-09-03,2024-09-19,ACTUAL,2023-02-07,ACTUAL,2023-02-07,2024-09,2024-09-30,2024-08-29,ACTUAL,2024-08-29,2024-08-29,ACTUAL,2024-08-29,,INTERVENTIONAL,,,Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy,Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy,TERMINATED,,PHASE4,2.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,PI Request,f,,,,t,t,f,,,,,,,,,,,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,OTHER,,,,,,,2024,0.0
NCT05328102,,2022-04-04,2024-02-19,,2024-04-04,2022-04-11,2022-04-14,ACTUAL,2024-04-04,2024-04-30,ACTUAL,,,,2024-04-04,2024-04-30,ACTUAL,2022-04-15,ACTUAL,2022-04-15,2024-04,2024-04-30,2023-02-21,ACTUAL,2023-02-21,2023-02-21,ACTUAL,2023-02-21,,INTERVENTIONAL,,"Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.",Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Relapsed or Refractory (R/R) Diffuse Large-cell B-cell Lymphoma (DLBCL),"A Phase 2 Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of XmAb13676 (Plamotamab) Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma",TERMINATED,,PHASE2,3.0,ACTUAL,"Xencor, Inc.","Due to the early termination of the study in Part 1A, only 3 participants enrolled. No participants were enrolled in Part 1B or Part 2. Safety data is limited due to the small sample size. No efficacy data was collected for the secondary outcome measures.",4.0,,The study has been terminated early by the sponsor due to business decision.,,,,,,t,f,,,,,,,,,,,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,INDUSTRY,,,,,,,2023,0.0
NCT04929249,,2021-06-11,2024-08-20,,2024-08-20,2021-06-11,2021-06-18,ACTUAL,2024-08-20,2024-09-19,ACTUAL,,,,2024-08-20,2024-09-19,ACTUAL,2021-06-25,ACTUAL,2021-06-25,2024-08,2024-08-31,2023-09-15,ACTUAL,2023-09-15,2023-09-15,ACTUAL,2023-09-15,,INTERVENTIONAL,V-INITIATE,,A Randomized Study to Evaluate the Effect of an Inclisiran First Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE),"A Randomized, Multicenter, Open-label Trial Comparing the Effectiveness of an Inclisiran First Implementation Strategy to Usual Care on LDL Cholesterol (LDL-C) in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C (≥70 mg/dL) Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)",COMPLETED,,PHASE3,450.0,ACTUAL,Novartis,,2.0,,,,,,,,t,f,,,,,,,,,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,INDUSTRY,,,,,,,2023,1.0
NCT04945733,,2021-06-23,2024-07-03,,2024-08-22,2021-06-23,2021-06-30,ACTUAL,2024-08-22,2024-09-19,ACTUAL,,,,2024-08-22,2024-09-19,ACTUAL,2021-08-30,ACTUAL,2021-08-30,2024-08,2024-08-31,2023-07-03,ACTUAL,2023-07-03,2023-07-03,ACTUAL,2023-07-03,,INTERVENTIONAL,,,A Study of Amivantamab in Participants With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer,"A Phase 2, Open-label Study of Amivantamab in Subjects With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer",TERMINATED,,PHASE2,62.0,ACTUAL,Janssen Pharmaceutical K.K.,"The study was planned to be conducted in 2 cohorts: Phase 2a cohorts (including Phase 2a extension cohort) and Phase 2b expansion cohort. However, due to study termination, no participants were enrolled in Phase 2a extension and Phase 2b cohorts. Hence results were only presented for Phase 2a cohorts. Phase 2b specific outcome measure (overall survival) were not included in the results.",2.0,,Due to reconsideration of development strategy,f,,,,f,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,INDUSTRY,,,,,,,2023,0.0
NCT04659044,,2020-11-19,2024-04-25,,2024-08-23,2020-12-02,2020-12-09,ACTUAL,2024-08-23,2024-09-19,ACTUAL,,,,2024-08-23,2024-09-19,ACTUAL,2021-04-01,ACTUAL,2021-04-01,2024-08,2024-08-31,2024-03-29,ACTUAL,2024-03-29,2024-03-28,ACTUAL,2024-03-28,,INTERVENTIONAL,,,"Polatuzumab Vedotin, Venetoclax, and Rituximab and Hyaluronidase Human for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma","A Phase 2 Trial of the Combination of Polatuzumab Vedotin, Venetoclax and Rituximab and Hyaluronidase Human for Relapsed and Refractory Mantle Cell Lymphoma",TERMINATED,,PHASE2,3.0,ACTUAL,Academic and Community Cancer Research United,,1.0,,Trial closed due to low accrual rate,,,,,f,t,f,,,f,,,,,,,,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,OTHER,,,,,,,2024,0.0
NCT02110069,,2014-04-08,2020-12-11,,2023-08-29,2014-04-08,2014-04-10,ESTIMATED,2021-05-20,2021-05-24,ACTUAL,,,,2023-08-29,2023-09-21,ACTUAL,2017-06-14,ACTUAL,2017-06-14,2023-08,2023-08-31,2020-10-27,ACTUAL,2020-10-27,2019-10-02,ACTUAL,2019-10-02,,INTERVENTIONAL,,no analysis was performed as study was closed early,A Study to Compare Vincristine to Sirolimus for Treatment of High Risk Vascular Tumors,A Randomized Phase 2 Study of Vincristine Versus Sirolimus to Treat High Risk Kaposiform Hemangioendothelioma (KHE).,TERMINATED,,PHASE2,4.0,ACTUAL,Boston Children's Hospital,,2.0,,"This study was challenged by the incidence of KHE with KMP as this continued to be extremely rare, and very sporadic. In July of 2019 grant renewal funding ended.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,OTHER,,,,,,,2020,0.0
NCT03290781,,2017-09-06,2021-12-16,,2021-12-16,2017-09-20,2017-09-25,ACTUAL,2021-12-16,2022-01-14,ACTUAL,,,,2021-12-16,2022-01-14,ACTUAL,2018-04-04,ACTUAL,2018-04-04,2021-12,2021-12-31,2021-07-01,ACTUAL,2021-07-01,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,FIGARO UC 303,"The safety set consisted of all participants who had received at least 1 dose of Investigational Product (IP) in this study, regardless of treatment received during the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]).",An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis,"A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)",COMPLETED,,PHASE3,366.0,ACTUAL,Takeda,,3.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,INDUSTRY,,,,,,,2021,1.0
NCT03173560,,2017-05-22,2021-02-12,,2024-09-05,2017-05-31,2017-06-02,ACTUAL,2021-02-12,2021-03-05,ACTUAL,,,,2024-09-05,2024-09-19,ACTUAL,2017-08-17,ACTUAL,2017-08-17,2024-09,2024-09-30,2024-06-30,ACTUAL,2024-06-30,2020-02-14,ACTUAL,2020-02-14,,INTERVENTIONAL,,Full analysis set (FAS) included all randomized participants.,Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma,"A Randomized, Open-Label (Formerly Double-Blind), Phase 2 Trial to Assess Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18 mg vs. 14 mg QD) in Combination With Everolimus (5 mg QD) in Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment",COMPLETED,,PHASE2,343.0,ACTUAL,Eisai Inc.,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,INDUSTRY,,,,,,,2024,1.0
NCT02965911,,2016-11-15,,,2021-09-12,2016-11-15,2016-11-17,ESTIMATED,,,,,,,2021-09-12,2021-09-17,ACTUAL,2016-01,,2016-01-31,2021-09,2021-09-30,2021-09-08,ACTUAL,2021-09-08,2021-09-08,ESTIMATED,2021-09-08,,INTERVENTIONAL,,,Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA,A Randomized Controlled Clinical Trial on the Efficacy and Safety of Fenofibrate Combined With Ursodeoxycholic Acid in PBC Patients With an Incomplete Biochemical Response to UDCA,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Beijing 302 Hospital,,2.0,,No participants enrolled,f,,,,t,,,,,,,,,,,NO,,2024-10-15 04:59:39.683845,2024-10-15 04:59:39.683845,OTHER,,,,,,,2021,0.0
NCT05446129,,2022-07-01,,,2024-09-11,2022-07-01,2022-07-06,ACTUAL,,,,,,,2024-09-11,2024-09-19,ACTUAL,2022-09-27,ACTUAL,2022-09-27,2024-09,2024-09-30,2023-11-08,ACTUAL,2023-11-08,2023-08-11,ACTUAL,2023-08-11,,INTERVENTIONAL,,,A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery,"A Phase I Open Label Study to Assess Safety, Feasibility, Efficacy, and Biological Activity of Single Administration of Neoadjuvant Treatments Ezabenlimab in Combination With BI 765063 and Pembrolizumab in Combination With BI 765063 in Patients With Newly Diagnosed Surgically-resectable, Locoregional Colorectal Cancer",TERMINATED,,PHASE1,2.0,ACTUAL,Boehringer Ingelheim,,2.0,,Company decision,f,,,,f,t,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https:// www.mystudywindow.com/msw/datatransparency",2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,INDUSTRY,,,,,,,2023,0.0
NCT03435081,,2018-02-12,2020-12-04,,2022-08-11,2018-02-12,2018-02-15,ACTUAL,2021-01-22,2021-01-25,ACTUAL,,,,2022-08-11,2022-09-09,ACTUAL,2018-02-20,ACTUAL,2018-02-20,2022-08,2022-08-31,2021-08-16,ACTUAL,2021-08-16,2019-12-09,ACTUAL,2019-12-09,,INTERVENTIONAL,BREEZE-AD5,All randomized participants.,A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis",COMPLETED,,PHASE3,440.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,INDUSTRY,,,,,,,2021,1.0
NCT03904849,,2019-04-02,,,2024-09-11,2019-04-03,2019-04-05,ACTUAL,,,,,,,2024-09-11,2024-09-19,ACTUAL,2019-10-01,ACTUAL,2019-10-01,2024-09,2024-09-30,2020-04-30,ACTUAL,2020-04-30,2020-04-30,ACTUAL,2020-04-30,,INTERVENTIONAL,,,Cannabidiol for Alcohol Use Disorder,A Pilot Human Laboratory Study of Cannabidiol in Alcohol Use Disorder,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Medical University of South Carolina,,2.0,,This study was intended to produce pilot data for a center grant component that will no longer be conducted.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,OTHER,,,,,,,2020,0.0
NCT03742323,,2018-11-13,,,2021-09-02,2018-11-14,2018-11-15,ACTUAL,,,,,,,2021-09-02,2021-09-05,ACTUAL,2018-07-01,ACTUAL,2018-07-01,2021-09,2021-09-30,2020-06-02,ACTUAL,2020-06-02,2020-06-02,ACTUAL,2020-06-02,,INTERVENTIONAL,,,REALIB-LLA-2017: Idelalisib in Patients With Acute Lymphoblastic Leukemia,"Phase I-II Unmasked, Non-randomized Study Evaluating the Role of Idelalisib in Patients With Acute Lymphoblastic Leukemia (ALL) That is Relapsing or Refractory to Other Treatments, and in Older Patients With ALL for Whom Conventional Treatments Are Not Recommended",TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,PETHEMA Foundation,,1.0,,Because of low recruitment,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,OTHER,,,,,,,2020,0.0
NCT02603146,,2015-11-10,2023-10-30,,2023-11-30,2015-11-10,2015-11-11,ESTIMATED,2023-10-30,2023-11-21,ACTUAL,,,,2023-11-30,2023-12-20,ACTUAL,2016-04-27,ACTUAL,2016-04-27,2023-11,2023-11-30,2022-11-01,ACTUAL,2022-11-01,2022-11-01,ACTUAL,2022-11-01,,INTERVENTIONAL,StopRA,The intent-to-treat population includes all randomized participants.,Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis,Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis,TERMINATED,,PHASE2,144.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),"Enrollment closed at 144 randomized participants before reaching the target of 200 due to slow participant accrual. The decision was supported by a revised power analysis suggesting sufficient power for the study with reduced numbers assuming a clinically-relevant difference in RA rates between arms (50% risk for placebo \& 25% risk for HCQ). In the 1st interim analysis after enrollment closure, the follow up \& treatment of the active participants were stopped early due to evidence of futility.",2.0,,"Enrollment was closed before reaching the target. In the 1st interim analysis after enrollment closure, the follow up \& treatment of active participants were stopped early due to evidence of futility.",f,,,,t,,,,,,,,After completion of the study.,"When posted, the IPD will be available to the public.",http://www.immport.org/,YES,"The plan is to share data in ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts, upon completion of the trial.",2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,NIH,,,,,,,2022,0.0
NCT03712358,,2018-10-05,2022-12-09,,2024-09-04,2018-10-17,2018-10-19,ACTUAL,2024-09-04,2024-09-19,ACTUAL,,,,2024-09-04,2024-09-19,ACTUAL,2018-11-26,ACTUAL,2018-11-26,2024-04,2024-04-30,2021-03-23,ACTUAL,2021-03-23,2021-03-23,ACTUAL,2021-03-23,,INTERVENTIONAL,,Study closed to enrollment due to business decision prior to enrolling Cohort 4.,PVSRIPO for Patients With Unresectable Melanoma,A Phase I Trial of PVSRIPO for Patients With Unresectable Melanoma,TERMINATED,,PHASE1,12.0,ACTUAL,"Istari Oncology, Inc.",,5.0,,Study closed to enrollment due to business decision prior to enrolling Cohort 4,,,,,t,t,f,,,,,,,,,,,2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,INDUSTRY,,,,,,,2021,0.0
NCT04558125,,2020-09-19,2021-09-21,,2021-10-20,2020-09-21,2020-09-22,ACTUAL,2021-10-20,2021-10-26,ACTUAL,,,,2021-10-20,2021-10-26,ACTUAL,2020-09-08,ACTUAL,2020-09-08,2021-10,2021-10-31,2021-08-08,ACTUAL,2021-08-08,2021-07-10,ACTUAL,2021-07-10,,INTERVENTIONAL,,"The study was terminated early and never unblinded. With only 2 subjects, statistical significance could never be demonstrated. Therefore, Arm/Group randomization information is not available.",Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism,"Low-Dose Tenecteplase in Covid-19 Patients With Acute Pulmonary Embolism: A Randomized, Double-Blind, Placebo-Controlled Trial",TERMINATED,,PHASE4,2.0,ACTUAL,Cedars-Sinai Medical Center,"The study was terminated early due to enrollment being slower than anticipated, with study enrollment highly dependent upon COVID-19 surge patterns. We were otherwise hopeful to enroll and complete all assessments for this study.",2.0,,Identification of eligible patients was slower than anticipated.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,OTHER,,,,,,,2021,0.0
NCT04524949,,2020-08-11,,,2024-06-20,2020-08-21,2020-08-24,ACTUAL,,,,,,,2024-06-20,2024-06-24,ACTUAL,2020-12-29,ACTUAL,2020-12-29,2024-06,2024-06-30,2024-05-29,ACTUAL,2024-05-29,2024-01-26,ACTUAL,2024-01-26,,INTERVENTIONAL,IMPACT,,IMCY-0098 Proof of ACtion in Type 1 Diabetes (IMPACT Study),"A Phase IIa, Randomized, Double-blind, Dose Comparison, Placebo-controlled, Multi-centre Clinical Trial to Evaluate the Immune Signature of the Treatment With the Imotope IMCY-0098 and Its Effect on the Preservation of Beta-cell Function in Adult Patients With a Recent Onset Type 1 Diabetes",TERMINATED,,PHASE2,110.0,ACTUAL,Imcyse SA,,3.0,,No efficacy at primary analysis after 1 year. Long term follow-up stopped,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,INDUSTRY,,,,,,,2024,0.0
NCT04106557,,2019-09-25,2022-11-15,,2024-01-05,2019-09-25,2019-09-27,ACTUAL,2024-01-05,2024-01-08,ACTUAL,,,,2024-01-05,2024-01-08,ACTUAL,2019-09-09,ACTUAL,2019-09-09,2024-01,2024-01-31,2020-11-02,ACTUAL,2020-11-02,2020-11-02,ACTUAL,2020-11-02,,INTERVENTIONAL,NEPTUNE,,A Study of OV101 in Individuals With Angelman Syndrome (AS),"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of OV101 in Pediatric Individuals With Angelman Syndrome",COMPLETED,,PHASE3,104.0,ACTUAL,Ovid Therapeutics Inc.,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,INDUSTRY,,,,,,,2020,0.0
NCT01950182,,2013-09-18,,,2020-07-13,2013-09-21,2013-09-25,ESTIMATED,,,,,,,2020-07-13,2020-07-15,ACTUAL,2013-09-16,ACTUAL,2013-09-16,2020-07,2020-07-31,2020-05-31,ACTUAL,2020-05-31,2020-05-31,ACTUAL,2020-05-31,,INTERVENTIONAL,SYSUCC-002,,Trastuzumab Combined With Chemotherapy or Endocrine Therapy to Treat Metastatic Luminal B2 Breast Cancer,"A Multicentre, Randomized Study of Trastuzumab Combined With Chemotherapy or Endocrine Therapy as the First Line Treatment for Patients With Metastatic Luminal B2 Breast Cancer Subtype",COMPLETED,,PHASE3,392.0,ACTUAL,Sun Yat-sen University,,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,OTHER,,,,,,,2020,1.0
NCT04639245,,2020-11-13,2023-07-11,,2023-07-11,2020-11-19,2020-11-20,ACTUAL,2023-07-11,2023-08-03,ACTUAL,,,,2023-07-11,2023-08-03,ACTUAL,2021-07-19,ACTUAL,2021-07-19,2023-07,2023-07-31,2022-08-16,ACTUAL,2022-08-16,2022-08-04,ACTUAL,2022-08-04,,INTERVENTIONAL,,,"Genetically Engineered Cells (MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells) and Atezolizumab for the Treatment of Metastatic Triple Negative Breast Cancer, Urothelial Cancer, or Non-small Cell Lung Cancer",ATTAMAGE-A1.: Phase I/II Study of Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity MAGE-A1-Specific T-Cell Receptor (TCR) Combined With Atezolizumab in Patients With Metastatic MAGE-A1 Expressing Cancer,TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,Fred Hutchinson Cancer Center,,1.0,,Terminated due to slow accrual.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,OTHER,,,,,,,2022,0.0
NCT02613507,,2015-11-22,2018-09-13,,2024-08-28,2015-11-22,2015-11-24,ESTIMATED,2019-02-21,2019-02-22,ACTUAL,,,,2024-08-28,2024-09-19,ACTUAL,2015-12-11,ACTUAL,2015-12-11,2024-08,2024-08-31,2023-11-24,ACTUAL,2023-11-24,2017-09-15,ACTUAL,2017-09-15,,INTERVENTIONAL,CheckMate 078,,Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer,An Open-label Randomized Multinational Phase 3 Trial of Nivolumab Versus Docetaxel in Previously Treated Subjects With Advanced or Metastatic Non-small Cell Lung Cancer (CheckMate 078: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 078),COMPLETED,,PHASE3,639.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,INDUSTRY,,,,,,,2023,1.0
NCT02864394,,2016-08-10,2020-09-08,,2024-08-30,2016-08-10,2016-08-12,ESTIMATED,2020-09-08,2020-10-05,ACTUAL,,,,2024-08-30,2024-09-19,ACTUAL,2016-09-07,ACTUAL,2016-09-07,2024-08,2024-08-31,2022-10-14,ACTUAL,2022-10-14,2019-09-09,ACTUAL,2019-09-09,,INTERVENTIONAL,,,Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033),"A Multinational, Multicenter, Phase III, Randomized Open-label Trial of Pembrolizumab Versus Docetaxel in Previously Treated Subjects With Non-Small Cell Lung Cancer",COMPLETED,,PHASE3,425.0,ACTUAL,Merck Sharp & Dohme LLC,Protocol amendment 5 called for participant discontinuation from this study under protocol-specified circumstances.,2.0,,,f,,,,t,f,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,INDUSTRY,,,,,,,2022,1.0
NCT05135000,,2021-11-16,,,2024-09-04,2021-11-16,2021-11-26,ACTUAL,,,,,,,2024-09-04,2024-09-19,ACTUAL,2022-06-30,ACTUAL,2022-06-30,2024-08,2024-08-31,2024-04-25,ACTUAL,2024-04-25,2024-03-20,ACTUAL,2024-03-20,,INTERVENTIONAL,,,Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension,"A Randomized, Participant- and Investigator-blinded, Placebo-controlled Study to Investigate Efficacy, Safety, and Tolerability of LTP001 in Participants With Pulmonary Arterial Hypertension",TERMINATED,,PHASE2,47.0,ACTUAL,Novartis,,2.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,INDUSTRY,,,,,,,2024,0.0
NCT04272242,,2020-02-12,2024-04-11,,2024-09-16,2020-02-13,2020-02-17,ACTUAL,2024-07-16,2024-08-09,ACTUAL,,,,2024-09-16,2024-09-19,ACTUAL,2021-02-27,ACTUAL,2021-02-27,2024-09,2024-09-30,2021-12-27,ACTUAL,2021-12-27,2021-12-15,ACTUAL,2021-12-15,,INTERVENTIONAL,,All participants who enrolled to the study,Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals,Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals,TERMINATED,,PHASE2,37.0,ACTUAL,National Institute of Allergy and Infectious Diseases (NIAID),,2.0,,Opening of Arm 2 was dependent upon assessment of DTG pharmacokinetics (PK) data from participants in Arm 1. Arm 1 is complete and results are reported. Arm 2 was not conducted based on the Arm 1 PK assessment.,f,,,,t,t,f,,,,,,Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.,* With whom?~  * Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses?~  * To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism will data be made available?~  * Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at: https://submit.mis.s-3.net/ Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.,,YES,"Individual participant data that underlie results in the publication, after deidentification.",2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,NIH,,,,,,,2021,0.0
NCT03414983,,2018-01-24,2022-02-01,,2023-10-27,2018-01-24,2018-01-30,ACTUAL,2022-02-01,2022-02-25,ACTUAL,,,,2023-10-27,2023-11-18,ACTUAL,2018-02-20,ACTUAL,2018-02-20,2023-10,2023-10-31,2022-12-28,ACTUAL,2022-12-28,2021-02-01,ACTUAL,2021-02-01,,INTERVENTIONAL,CheckMate 9X8,,An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread,An Open-Label Exploratory Phase 2/3 Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Metastatic Colorectal Cancer,COMPLETED,,PHASE2/PHASE3,196.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,INDUSTRY,,,,,,,2022,1.0
NCT02212015,,2014-07-29,2021-11-04,,2022-01-21,2014-08-06,2014-08-08,ESTIMATED,2022-01-21,2022-03-22,ACTUAL,,,,2022-01-21,2022-03-22,ACTUAL,2014-07,,2014-07-31,2022-01,2022-01-31,2020-07-01,ACTUAL,2020-07-01,2019-12-31,ACTUAL,2019-12-31,,INTERVENTIONAL,EVA,,Evaluation of Votrient in Angiosarcoma,"Single-arm, Multicenter, Open Label Phase II Trial to Evaluate the Efficacy of Pazopanib in Combination With Paclitaxel in Advanced and Relapsed Angiosarcoma",TERMINATED,,PHASE2,26.0,ACTUAL,Heidelberg University,,1.0,,Due to interim analysis' results and definitions fixed in protocol,f,,,,f,,,,,,,,,,,,,2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,OTHER,,,,,,,2020,0.0
NCT03361137,,2017-11-20,2021-02-09,,2021-02-09,2017-11-28,2017-12-04,ACTUAL,2021-02-09,2021-03-01,ACTUAL,,,,2021-02-09,2021-03-01,ACTUAL,2018-06-28,ACTUAL,2018-06-28,2021-02,2021-02-28,2020-03-13,ACTUAL,2020-03-13,2020-03-13,ACTUAL,2020-03-13,,INTERVENTIONAL,,,Study of Emicizumab Prophylaxis in Participants With Hemophilia A With or Without Inhibitors Undergoing Minor Surgical Procedures,"A Phase IV, Multicenter, Single-Arm, Open-Label Study of Emicizumab Prophylaxis in Patients With Hemophilia A With or Without Inhibitors Undergoing Minor Surgical Procedures",TERMINATED,,PHASE4,14.0,ACTUAL,"Genentech, Inc.","No definitive efficacy conclusions were drawn due to study limitations that included early enrollment termination, limited number of participants enrolled, and evaluation in only 2 minor surgical procedure types.",5.0,,"The Sponsor decided to terminate the study early for several reasons (low enrollment, limited variety of surgery types, and available scientific data).",f,,,,,t,f,,,,,,,,,,,2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,INDUSTRY,,,,,,,2020,0.0
NCT03175367,,2017-06-01,2022-12-19,2021-05-20,2023-01-27,2017-06-01,2017-06-05,ACTUAL,2023-01-27,2023-02-10,ACTUAL,2023-01-27,2023-02-10,ACTUAL,2023-01-27,2023-02-10,ACTUAL,2017-11-10,ACTUAL,2017-11-10,2023-01,2023-01-31,2020-12-14,ACTUAL,2020-12-14,2020-05-22,ACTUAL,2020-05-22,,INTERVENTIONAL,,,Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia,"A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients With Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy",COMPLETED,,PHASE2,272.0,ACTUAL,Regeneron Pharmaceuticals,,7.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,INDUSTRY,,,,,,,2020,1.0
NCT03493464,,2018-04-04,2024-07-11,,2024-09-16,2018-04-04,2018-04-10,ACTUAL,2024-09-16,2024-09-19,ACTUAL,,,,2024-09-16,2024-09-19,ACTUAL,2018-12-13,ACTUAL,2018-12-13,2024-09,2024-09-30,2021-07-31,ACTUAL,2021-07-31,2021-04-15,ACTUAL,2021-04-15,,INTERVENTIONAL,,All participants enrolled and dosed in the study who provided demographic information.,BR55 in Characterization of Ovarian Lesions,BR55 Contrast Enhanced Ultrasound (CEUS) in Characterization of Ovarian Lesions,TERMINATED,,PHASE2,14.0,ACTUAL,"Bracco Diagnostics, Inc",,1.0,,Sponsor decision; expiration of available study agent due to long recruitment timeline.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,INDUSTRY,,,,,,,2021,0.0
NCT02404935,,2015-03-23,,,2022-03-23,2015-03-31,2015-04-01,ESTIMATED,,,,,,,2022-03-23,2022-03-24,ACTUAL,2013-11-22,ACTUAL,2013-11-22,2022-03,2022-03-31,2021-10-25,ACTUAL,2021-10-25,2020-11-01,ACTUAL,2020-11-01,,INTERVENTIONAL,TIME,,Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC),Randomized Phase II Study of First-line FOLFIRI Plus Cetuximab for 8 Cycles Followed by Either Single-agent Cetuximab as Maintenance Therapy or Observation in Patients With Wild-type KRAS and NRAS Metastatic Colorectal Cancer,COMPLETED,,PHASE2,139.0,ACTUAL,UNICANCER,,2.0,,,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 05:05:04.131219,2024-10-15 05:05:04.131219,OTHER,,,,,,,2021,0.0
NCT03965091,,2019-05-23,2023-01-15,,2023-03-03,2019-05-23,2019-05-28,ACTUAL,2023-03-03,2023-03-30,ACTUAL,,,,2023-03-03,2023-03-30,ACTUAL,2019-07-31,ACTUAL,2019-07-31,2023-03,2023-03-31,2022-01-19,ACTUAL,2022-01-19,2022-01-19,ACTUAL,2022-01-19,,INTERVENTIONAL,,The intent-to-treat (ITT) analysis set included all randomized participants.,A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of the Efficacy and Safety of Fremanezumab for Treatment of Patients With Fibromyalgia",TERMINATED,,PHASE2,189.0,ACTUAL,"Teva Branded Pharmaceutical Products R&D, Inc.",,3.0,,Met pre-specified criteria for futility at interim analysis,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.",2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,INDUSTRY,,,,,,,2022,0.0
NCT04944992,,2021-06-28,2023-09-27,,2023-10-25,2021-06-28,2021-06-30,ACTUAL,2023-10-25,2023-11-15,ACTUAL,,,,2023-10-25,2023-11-15,ACTUAL,2021-08-04,ACTUAL,2021-08-04,2023-10,2023-10-31,2022-10-19,ACTUAL,2022-10-19,2022-10-19,ACTUAL,2022-10-19,,INTERVENTIONAL,,,A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001),"A Phase 2a, Randomized, Active-Comparator-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Individuals With Nonalcoholic Fatty Liver Disease",COMPLETED,,PHASE2,145.0,ACTUAL,Merck Sharp & Dohme LLC,,2.0,,,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,INDUSTRY,,,,,,,2022,1.0
NCT05557110,,2022-09-16,,,2024-09-11,2022-09-25,2022-09-27,ACTUAL,,,,,,,2024-09-11,2024-09-19,ACTUAL,2022-09-08,ACTUAL,2022-09-08,2024-09,2024-09-30,2024-03-31,ACTUAL,2024-03-31,2024-01-05,ACTUAL,2024-01-05,,INTERVENTIONAL,,,Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Ph-B-ALL,"A Multicenter, Single-arm, Open-end Study of Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Philadelphia Chromosome Negative Acute B Lymphoblastic Leukemia",COMPLETED,,PHASE2,35.0,ACTUAL,The First Affiliated Hospital of Soochow University,,1.0,,,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,OTHER,,,,,,,2024,1.0
NCT05387239,,2022-05-16,,,2024-09-12,2022-05-23,2022-05-24,ACTUAL,,,,,,,2024-09-12,2024-09-19,ACTUAL,2022-11-30,ACTUAL,2022-11-30,2024-09,2024-09-30,2024-12,ESTIMATED,2024-12-31,2024-11,ESTIMATED,2024-11-30,,INTERVENTIONAL,,,Safety and Effectiveness of VL-PX10 + VL-P22 Treatment on Pulmonary Fibrosis Secondary to Covid-19,Safety and Effectiveness of VL-PX10 + VL-P22 Treatment on Pulmonary Fibrosis Secondary to Covid-19,SUSPENDED,,PHASE2,20.0,ESTIMATED,"Vitti Labs, LLC",,2.0,,Sponsor request,f,,,,,t,f,,,,,,,,,,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,INDUSTRY,,,,,,,2024,0.0
NCT03969212,,2019-05-29,,,2024-05-22,2019-05-29,2019-05-31,ACTUAL,,,,,,,2024-05-22,2024-05-23,ACTUAL,2019-10-10,ACTUAL,2019-10-10,2024-05,2024-05-31,2024-05-10,ACTUAL,2024-05-10,2024-05-10,ACTUAL,2024-05-10,,INTERVENTIONAL,,,Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households,"A Phase IIIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Clinical Efficacy Study of Baloxavir Marboxil for the Reduction of Direct Transmission of Influenza From Otherwise Healthy Patients to Household Contacts",COMPLETED,,PHASE3,4176.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)",2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,INDUSTRY,,,,,,,2024,1.0
NCT03371498,,2017-11-30,,,2023-12-27,2017-12-06,2017-12-13,ACTUAL,,,,,,,2023-12-27,2024-01-03,ACTUAL,2018-12-27,ACTUAL,2018-12-27,2023-12,2023-12-31,2023-11-29,ACTUAL,2023-11-29,2023-11-29,ACTUAL,2023-11-29,,INTERVENTIONAL,ProCoCo,,Procollagen-3 Driven Corticosteroids for Persistent Acute Respiratory Distress Syndrome,Procollagen-3 Driven Corticosteroids for Persistent Acute Respiratory Distress Syndrome,TERMINATED,,PHASE3,21.0,ACTUAL,Assistance Publique Hopitaux De Marseille,,2.0,,Insufficient recruitment of eligible patients.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,OTHER,,,,,,,2023,0.0
NCT04084158,,2019-09-05,,,2021-02-19,2019-09-09,2019-09-10,ACTUAL,,,,,,,2021-02-19,2021-02-23,ACTUAL,2019-09-07,ACTUAL,2019-09-07,2021-02,2021-02-28,2021-12-30,ESTIMATED,2021-12-30,2021-12-30,ESTIMATED,2021-12-30,,INTERVENTIONAL,,,A Study of Toripalimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma.,"A Phase II, Randomized, Open Label, Multi-center Design Study of Toripalimab Given Before and After Concurrent Chemoradiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma",SUSPENDED,,PHASE2,100.0,ESTIMATED,Zhejiang Cancer Hospital,,2.0,,combination arm delevelped significant poor prognosis,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,OTHER,,,,,,,2021,0.0
NCT03933007,,2019-02-08,,,2024-05-31,2019-04-26,2019-05-01,ACTUAL,,,,,,,2024-05-31,2024-06-03,ACTUAL,2019-09-10,ACTUAL,2019-09-10,2024-05,2024-05-31,2024-02-28,ACTUAL,2024-02-28,2019-10-10,ACTUAL,2019-10-10,,INTERVENTIONAL,COMpARE,,Relation Between Blood Concentration of Colchicine and Response to Colchicine Treatment in Gout Flare,Comparison of Maximum Blood Concentrations of Colchicine Between Responders and Non-responders to Colchicine Treatment During Gout Flare,TERMINATED,,PHASE4,26.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,1.0,,faillure of recrutement,f,,,,f,f,f,,,,,,,,,,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,OTHER,,,,,,,2024,0.0
NCT03081117,,2017-03-09,2021-04-30,,2021-06-15,2017-03-09,2017-03-16,ACTUAL,2021-06-15,2021-07-07,ACTUAL,,,,2021-06-15,2021-07-07,ACTUAL,2017-08-01,ACTUAL,2017-08-01,2021-06,2021-06-30,2020-10-16,ACTUAL,2020-10-16,2020-05-20,ACTUAL,2020-05-20,,INTERVENTIONAL,,,Intranasal Insulin for the Treatment of HAND,Clinical Trial of Intranasal Insulin for the Treatment of HIV-associated Neurocognitive Disorder (HAND),TERMINATED,,PHASE1/PHASE2,21.0,ACTUAL,Johns Hopkins University,,2.0,,"On 3/15/2020 study visits were suspended due to COVID-19 pandemic. With safety concerns surrounding COVID-19 and difficulty recruiting, the investigators decided to close enrollment 10/16/2020 after interim data were reviewed by the DSMB and NIH.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,OTHER,,,,,,,2020,0.0
NCT03413891,,2018-01-18,2021-02-25,,2024-02-20,2018-01-26,2018-01-29,ACTUAL,2024-02-20,2024-08-01,ACTUAL,,,,2024-02-20,2024-08-01,ACTUAL,2018-02-07,ACTUAL,2018-02-07,2024-02,2024-02-29,2020-03-19,ACTUAL,2020-03-19,2020-03-19,ACTUAL,2020-03-19,,INTERVENTIONAL,EXTRACT-NOAC,All randomized patients except those who were lost to follow-up or who had a protocol violation were included in the full analysis set.,Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction,Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction,TERMINATED,,PHASE4,222.0,ACTUAL,Universitaire Ziekenhuizen KU Leuven,,2.0,,Advice from DSMB,f,,,,f,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,OTHER,,,,,,,2020,0.0
NCT05074992,,2021-06-25,,,2024-05-01,2021-09-29,2021-10-12,ACTUAL,,,,,,,2024-05-01,2024-05-02,ACTUAL,2022-08-24,ACTUAL,2022-08-24,2024-05,2024-05-31,2023-05-02,ACTUAL,2023-05-02,2023-05-02,ACTUAL,2023-05-02,,INTERVENTIONAL,NeAT Glio,,A Trial of Neoadjuvant Therapy in Patients With Newly Diagnosed Glioblastoma,A Phase II Trial of Neoadjuvant Therapy in Patients With Newly Diagnosed Glioblastoma,TERMINATED,,PHASE2,1.0,ACTUAL,"University College, London",,1.0,,Support withdrawn from drug company supplying IMP,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,OTHER,,,,,,,2023,0.0
NCT03435250,,2018-02-01,,,2024-07-24,2018-02-09,2018-02-19,ACTUAL,,,,,,,2024-07-24,2024-07-25,ACTUAL,2018-03-04,ACTUAL,2018-03-04,2024-07,2024-07-31,2023-04-20,ACTUAL,2023-04-20,2023-04-20,ACTUAL,2023-04-20,,INTERVENTIONAL,,,Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss,A Phase 1 Study of AG-270 in the Treatment of Subjects With Advanced Solid Tumors or Lymphoma With Homozygous Deletion of MTAP,TERMINATED,,PHASE1,123.0,ACTUAL,Servier,,3.0,,Strategic reasons,f,,,,f,t,f,,,,,,After Marketing Authorisation in EEA or US if the study is used for the approval.,Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.,https://clinicaltrials.servier.com/,YES,"Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.",2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,INDUSTRY,,,,,,,2023,0.0
NCT03971422,,2019-05-29,2023-07-27,2022-08-30,2023-08-22,2019-05-29,2019-06-03,ACTUAL,2023-07-27,2023-08-21,ACTUAL,2022-08-30,2022-08-31,ACTUAL,2023-08-22,2023-09-05,ACTUAL,2019-06-03,ACTUAL,2019-06-03,2023-08,2023-08-31,2021-10-26,ACTUAL,2021-10-26,2021-08-31,ACTUAL,2021-08-31,,INTERVENTIONAL,,Baseline Characteristics refers to the Randomized Set (RS) which consisted of all study participants who were randomized and analyzed according to the treatment assigned instead of the actual treatment received.,A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis",COMPLETED,,PHASE3,200.0,ACTUAL,UCB Pharma,,3.0,,,f,,,,t,t,f,,,f,,,"Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.","Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.",https://www.Vivli.org,YES,"Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.",2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,INDUSTRY,,,,,,,2021,1.0
NCT04730804,,2021-01-26,2023-08-09,,2024-09-16,2021-01-26,2021-01-29,ACTUAL,2024-09-16,2024-09-19,ACTUAL,,,,2024-09-16,2024-09-19,ACTUAL,2021-03-17,ACTUAL,2021-03-17,2024-09,2024-09-30,2022-01-04,ACTUAL,2022-01-04,2021-12-14,ACTUAL,2021-12-14,,INTERVENTIONAL,,The Safety Set included all participants who received at least 1 dose of study drug.,A Study of ALXN1830 in Healthy Adult Participants,"A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of Subcutaneous ALXN1830 in Healthy Participants",TERMINATED,,PHASE1,34.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,6.0,,Sponsor decision to terminate program,f,,,,f,t,f,,,t,,,,,,UNDECIDED,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,INDUSTRY,,,,,,,2022,0.0
NCT04880278,,2021-04-29,,,2024-05-19,2021-05-06,2021-05-10,ACTUAL,,,,,,,2024-05-19,2024-05-21,ACTUAL,2022-03-01,ACTUAL,2022-03-01,2024-05,2024-05-31,2024-05-08,ACTUAL,2024-05-08,2024-05-08,ACTUAL,2024-05-08,,INTERVENTIONAL,,,Multimodal Assessment of Cannabinoid Target Engagement in Adults With Obsessive-Compulsive Disorder,Multimodal Assessment of Cannabinoid Target Engagement in Adults With Obsessive-Compulsive Disorder,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,New York State Psychiatric Institute,,2.0,,The Principal Investigator is no longer at the Institution and a request for early termination of the grant supporting the study was submitted to NIH.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,OTHER,,,,,,,2024,0.0
NCT03432676,,2018-02-06,,,2019-05-28,2018-02-12,2018-02-14,ACTUAL,,,,,,,2019-05-28,2019-05-30,ACTUAL,2019-07-31,ESTIMATED,2019-07-31,2019-05,2019-05-31,2021-04-30,ESTIMATED,2021-04-30,2020-04-30,ESTIMATED,2020-04-30,,INTERVENTIONAL,,,Epacadostat and Pembrolizumab in Treating Participants With Advanced Pancreatic Cancer,"Single-Arm, Phase II Proof of Concept Study of IDO-1 Inhibitor Epacadostat in Combination With Pembrolizumab in Advanced Pancreatic Cancer With Chromosomal Instability/Homologous Recombination Repair Deficiency (HRD)",WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Incyte (supporter of the study) is no longer going to support the study.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,OTHER,,,,,,,2021,0.0
NCT04309734,,2020-03-13,,,2022-06-06,2020-03-13,2020-03-16,ACTUAL,,,,,,,2022-06-06,2022-06-08,ACTUAL,2021-10,ESTIMATED,2021-10-31,2022-06,2022-06-30,2022-09,ESTIMATED,2022-09-30,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects,A Phase I/IIa Study Assessing AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Atea Pharmaceuticals, Inc.",,4.0,,Withdrawn prior to study initiation.,f,,,,f,f,f,,,,,,,,,,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,INDUSTRY,,,,,,,2022,0.0
NCT05767749,,2023-02-22,2024-05-23,,2024-08-15,2023-03-02,2023-03-14,ACTUAL,2024-08-15,2024-09-19,ACTUAL,,,,2024-08-15,2024-09-19,ACTUAL,2023-03-14,ACTUAL,2023-03-14,2024-08,2024-08-31,2023-07-31,ACTUAL,2023-07-31,2023-07-31,ACTUAL,2023-07-31,,INTERVENTIONAL,,"Participants were excluded from analysis if they withdrew from the study (1 participant), did not regain sensation bilaterally before leaving the study site (3 participants), or, if the time to regain sensation could not be accurately determined (1 participant).",Split Face Study of the Duration of Local Anesthetics,Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery,COMPLETED,,PHASE4,75.0,ACTUAL,Weill Medical College of Cornell University,,3.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,OTHER,,,,,nasal ala,,2023,1.0
NCT04323124,,2020-03-18,2022-10-03,,2024-05-07,2020-03-25,2020-03-26,ACTUAL,2024-05-07,2024-09-19,ACTUAL,,,,2024-05-07,2024-09-19,ACTUAL,2020-07-17,ACTUAL,2020-07-17,2024-05,2024-05-31,2021-10-21,ACTUAL,2021-10-21,2021-10-21,ACTUAL,2021-10-21,,INTERVENTIONAL,,,Study of Single and Multiple Ascending Doses of PF-07059013 in Healthy Adult Participants,"A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE ESCALATION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-07059013 AND OPEN-LABEL ASSESSMENT OF FOOD AND FORMULATION ON PHARMACOKINETICS OF PF-07059013 IN HEALTHY ADULT PARTICIPANTS",TERMINATED,,PHASE1,61.0,ACTUAL,Pfizer,"After the completion of the Part 1 and Part 2, due to failure to demonstrate sufficient pharmacologic effect in relation to the study PK and pharmacodynamic (PD) objectives in healthy participants as defined in the study protocol, the study was terminated prematurely. The decision to terminate the study was made while Part 3 was in progress (5 participants enrolled).",2.0,,Study was terminated as it did not demonstrate sufficient pharmacological effect. Termination was not related to safety reasons.,f,,,,f,f,f,,,,,,,,,NO,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,INDUSTRY,,,,,,,2021,0.0
NCT05258721,,2022-02-17,2023-01-10,,2023-02-17,2022-02-17,2022-02-28,ACTUAL,2023-02-17,2023-03-15,ACTUAL,,,,2023-02-17,2023-03-15,ACTUAL,2021-07-06,ACTUAL,2021-07-06,2023-01,2023-01-31,2022-10-31,ACTUAL,2022-10-31,2022-10-31,ACTUAL,2022-10-31,,INTERVENTIONAL,,,"Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP","Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on Plaque, Gingival Inflammation and Bleeding Upon Probing",COMPLETED,,PHASE2,60.0,ACTUAL,"Rowpar Pharmaceuticals, Inc.",,1.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,INDUSTRY,,,,,,,2022,1.0
NCT04069234,,2019-08-20,,,2020-04-06,2019-08-23,2019-08-28,ACTUAL,,,,,,,2020-04-06,2020-04-08,ACTUAL,2019-09-15,ESTIMATED,2019-09-15,2020-04,2020-04-30,2022-03-31,ESTIMATED,2022-03-31,2021-10-15,ESTIMATED,2021-10-15,,INTERVENTIONAL,AUGEAS,,Study in Diabetes Mellitus Patients Without Prior Myocardial Infarction or Stroke Undergoing Elective Percutaneous Coronary Intervention.,"30-d Rand, Eval-blind, Controlled, Multi-centre, Parallel, ph III Study to Evaluate Effect of a Low Maint Dose Ticagrelor Regimen vs Standard Dose Clopidogrel on Coronary Flow Reserve in DM Patients With Impaired Microvascular Function Without Prior MI or Stroke Undergoing ePCI.",WITHDRAWN,,PHASE3,0.0,ACTUAL,Region Skane,,2.0,,Sponsor decided to stop the study due to commercial reasons.,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,OTHER,,,,,,,2022,0.0
NCT04355169,,2020-04-17,2021-12-17,,2021-12-17,2020-04-17,2020-04-21,ACTUAL,2021-12-17,2022-01-18,ACTUAL,,,,2021-12-17,2022-01-18,ACTUAL,2020-11-06,ACTUAL,2020-11-06,2021-12,2021-12-31,2021-01-04,ACTUAL,2021-01-04,2021-01-04,ACTUAL,2021-01-04,,INTERVENTIONAL,,"This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.",A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection,"A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Naldemedine in Patients Undergoing Surgeries That Include a Bowel Resection or Bowel Transection",TERMINATED,,PHASE2,2.0,ACTUAL,Shionogi Inc.,"This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.",4.0,,This study was terminated before the planned sample size was enrolled due to very slow enrollment.,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,INDUSTRY,,,,,,,2021,0.0
NCT04234477,,2020-01-16,,,2021-12-01,2020-01-16,2020-01-21,ACTUAL,,,,,,,2021-12-01,2021-12-15,ACTUAL,2021-12,ESTIMATED,2021-12-31,2021-11,2021-11-30,2022-06,ESTIMATED,2022-06-30,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,AIRCRAFT,,Assessment of Intravenous Rate Control Response in Atrial Fibrillation Trial (AIRCRAFT),Assessment of Intravenous Rate Control Response in Atrial Fibrillation Trial Pilot Study (AIRCRAFT),WITHDRAWN,,PHASE4,0.0,ACTUAL,Boston University,,3.0,,The study was not IRB approved and there were anticipated challenges in recruiting participants.,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,OTHER,,,,,,,2022,0.0
NCT03094416,,2017-03-17,2022-02-04,2021-05-10,2022-04-01,2017-03-22,2017-03-29,ACTUAL,2022-04-01,2022-04-05,ACTUAL,2022-04-01,2022-04-05,ACTUAL,2022-04-01,2022-04-05,ACTUAL,2018-07-30,ACTUAL,2018-07-30,2022-04,2022-04-30,2020-06-15,ACTUAL,2020-06-15,2020-06-15,ACTUAL,2020-06-15,,INTERVENTIONAL,,intention to treat (ITT),Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors,An Open-label Therapeutic Efficacy Study of Tirosint (Levothyroxine Sodium) Capsules in Thyroidectomized Patients Taking Proton Pump Inhibitors,COMPLETED,,PHASE4,66.0,ACTUAL,IBSA Institut Biochimique SA,"Due to Covid-19 pandemic outbreak leading to discontinuation of subjects, primary endpoint was assessed on 43 subjects instead of 48 subjects (as planned in the sample size calculation). The a-posteriori study power is 91%.",1.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,INDUSTRY,,,,,,,2020,1.0
NCT03868423,,2019-02-04,,,2022-02-15,2019-03-06,2019-03-11,ACTUAL,,,,,,,2022-02-15,2022-02-18,ACTUAL,2019-03-20,ACTUAL,2019-03-20,2022-02,2022-02-28,2021-12-30,ESTIMATED,2021-12-30,2020-11-20,ACTUAL,2020-11-20,,INTERVENTIONAL,,,Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers,Phase II Study of Brigatinib for Advanced Solid Cancers Harboring Genomic Alterations in ALK (Excluding Lung) and ROS1 Oncogenes,WITHDRAWN,,PHASE2,0.0,ACTUAL,Ohio State University Comprehensive Cancer Center,,1.0,,PI decision,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,OTHER,,,,,,,2021,0.0
NCT01668784,,2012-08-16,2016-03-28,,2022-07-15,2012-08-16,2012-08-20,ESTIMATED,2016-04-28,2016-04-29,ESTIMATED,,,,2022-07-15,2022-08-09,ACTUAL,2012-10-09,ACTUAL,2012-10-09,2022-07,2022-07-31,2021-07-19,ACTUAL,2021-07-19,2015-05-06,ACTUAL,2015-05-06,,INTERVENTIONAL,,All randomized participants; any participant that was randomized to any treatment group in the study.,Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025),"A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy",COMPLETED,,PHASE3,821.0,ACTUAL,Bristol-Myers Squibb,,2.0,,,t,,,,t,t,f,,,,,,,,,,,2024-10-15 05:10:37.581636,2024-10-15 05:10:37.581636,INDUSTRY,,NCT03126643,APPROVED_FOR_MARKETING,,,,2021,1.0
NCT05992922,,2023-08-08,,,2024-09-06,2023-08-08,2023-08-15,ACTUAL,,,,,,,2024-09-06,2024-09-19,ACTUAL,2023-10-17,ACTUAL,2023-10-17,2024-09,2024-09-30,2023-12-19,ACTUAL,2023-12-19,2023-12-19,ACTUAL,2023-12-19,,INTERVENTIONAL,,,A Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution for Dry Eye in Adult Participants,"A Phase 2, Single-Center, Randomized, Double- Masked, Placebo-Controlled Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution 1% in Subjects Diagnosed With Dry Eye Disease",TERMINATED,,PHASE2,40.0,ACTUAL,Iacta Pharmaceuticals,,2.0,,Unexpected adverse events were observed in a subset of patients on drug. In an over abundance of caution the study was terminated. All adverse events resolved with no sequelae.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,INDUSTRY,,,,,,,2023,0.0
NCT01454102,,2011-09-16,2017-12-19,,2021-09-20,2011-10-17,2011-10-18,ESTIMATED,2019-08-02,2019-08-05,ACTUAL,,,,2021-09-20,2021-10-12,ACTUAL,2011-12-16,ACTUAL,2011-12-16,2021-09,2021-09-30,2021-07-23,ACTUAL,2021-07-23,2016-07-20,ACTUAL,2016-07-20,,INTERVENTIONAL,,,"Study of Nivolumab (BMS-936558) in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) (CheckMate 012)","A Multi-arm Phase I Safety Study of Nivolumab in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)",COMPLETED,,PHASE1,472.0,ACTUAL,Bristol-Myers Squibb,,19.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,INDUSTRY,,,,,,,2021,1.0
NCT04790916,,2021-03-08,2022-11-08,,2022-11-08,2021-03-08,2021-03-10,ACTUAL,2022-11-08,2023-09-18,ACTUAL,,,,2022-11-08,2023-09-18,ACTUAL,2021-04-19,ACTUAL,2021-04-19,2022-11,2022-11-30,2021-11-18,ACTUAL,2021-11-18,2021-11-18,ACTUAL,2021-11-18,,INTERVENTIONAL,,"The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.",Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH),"A Double-Blind, Randomized, Parallel-Group, Phase 2 Study to Investigate the Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Patients With Autoimmune Hepatitis",TERMINATED,,PHASE2,2.0,ACTUAL,Hoffmann-La Roche,"The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.",3.0,,A lack of efficacy was seen with RO7049665 in a study of ulcerative colitis. This reduces the likelihood that the drug is effective in autoimmune hepatitis.,f,,,,t,f,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,INDUSTRY,,,,,,,2021,0.0
NCT04396756,,2020-05-06,2024-02-15,,2024-05-16,2020-05-15,2020-05-21,ACTUAL,2024-04-02,2024-04-30,ACTUAL,,,,2024-05-16,2024-06-03,ACTUAL,2020-03-03,ACTUAL,2020-03-03,2024-02,2024-02-29,2023-02-15,ACTUAL,2023-02-15,2023-02-01,ACTUAL,2023-02-01,,INTERVENTIONAL,,Safety Population included all participants who took at least 1 dose of study drug.~Overall Number of Participants is 120 not 121. One participant received both placebo and PLN-74809 320 mg due to incorrect study drug dispensation and is counted in the denominator of both treatment groups for demographic and safety reporting.,Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis,"A Randomized, Double-blind, Dose-ranging, Placebo Controlled Phase 2a Evaluation of the Safety, Tolerability and Pharmacokinetics of PLN-74809 in Participants With Idiopathic Pulmonary Fibrosis (INTEGRIS-IPF)",COMPLETED,,PHASE2,120.0,ACTUAL,"Pliant Therapeutics, Inc.",,7.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,INDUSTRY,,,,,,,2023,1.0
NCT04852172,,2021-03-18,,,2024-09-13,2021-04-20,2021-04-21,ACTUAL,,,,,,,2024-09-13,2024-09-19,ACTUAL,2021-04-29,ACTUAL,2021-04-29,2023-08,2023-08-31,2024-02-29,ACTUAL,2024-02-29,2024-02-29,ACTUAL,2024-02-29,,INTERVENTIONAL,,,L-citrulline Injection in Patients Aged 6-21 Years Old with Sickle Cell Disease Presenting with Vaso-Occlusive Crisis (VOC),"A Phase I/IIA Open-label Dose-Finding Study with Subsequent Double-blind, Placebo-controlled, Randomized Study of L-citrulline in Sickle Cell Disease Presenting to Emergency Department (ED) in Vaso Occlusive Crisis (VOC) in Children, Adolescents and Young Adults (6 to 21 Years)",TERMINATED,,PHASE1/PHASE2,30.0,ACTUAL,"Asklepion Pharmaceuticals, LLC",,6.0,,Impacted by viraemia resulting in higher than expected admissions,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,INDUSTRY,,,,,,,2024,0.0
NCT04530617,,2020-08-26,,,2021-06-15,2020-08-26,2020-08-28,ACTUAL,,,,,,,2021-06-15,2021-06-21,ACTUAL,2020-10-05,ACTUAL,2020-10-05,2020-08,2020-08-31,2021-06-10,ACTUAL,2021-06-10,2021-06-10,ACTUAL,2021-06-10,,INTERVENTIONAL,,,Camostat and Artemisia Annua vs Placebo in COVID-19 Outpatients,"Randomized, Double-blind, Placebo-controlled, Multicenter, Multi-arm, Phase II Trial of Novel Agents for the Treatment of Mild to Moderate COVID-19 Positive Outpatients",TERMINATED,,PHASE2,246.0,ACTUAL,Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran,,4.0,,Results from the interim analysis,f,,,,t,f,f,,,,,,,,,NO,All IPD results in the publication,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,OTHER,,,,,,,2021,0.0
NCT02420821,,2015-04-15,2018-08-21,,2023-01-04,2015-04-15,2015-04-20,ESTIMATED,2018-09-04,2018-10-03,ACTUAL,,,,2023-01-04,2023-01-30,ACTUAL,2015-05-20,ACTUAL,2015-05-20,2023-01,2023-01-31,2021-12-13,ACTUAL,2021-12-13,2020-02-14,ACTUAL,2020-02-14,,INTERVENTIONAL,IMmotion151,"Analysis was performed on the intent-to-treat (ITT) population, which included all randomized participants whether or not the assigned study treatment was received.",A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC),"A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma",COMPLETED,,PHASE3,915.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,,,,,,,,,,,,,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,INDUSTRY,,,,,,,2021,1.0
NCT03096288,,2017-03-23,2021-12-10,,2022-02-16,2017-03-24,2017-03-30,ACTUAL,2022-02-16,2022-02-17,ACTUAL,,,,2022-02-16,2022-02-17,ACTUAL,2017-10-03,ACTUAL,2017-10-03,2022-02,2022-02-28,2020-11-02,ACTUAL,2020-11-02,2020-11-02,ACTUAL,2020-11-02,,INTERVENTIONAL,,,Impact of Evolocumab on the Effects of Clopidogrel in Patients With High On-Treatment Platelet Reactivity,Impact of the PCSK9 Inhibitor Evolocumab on the Pharmacodynamic Effects of Clopidogrel in Patients With Atherosclerotic Cardiovascular Disease and High On-Treatment Platelet Reactivity,COMPLETED,,PHASE4,259.0,ACTUAL,University of Florida,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,OTHER,,,,,,,2020,1.0
NCT03387085,,2017-12-21,2024-04-03,,2024-08-05,2017-12-21,2017-12-29,ACTUAL,2024-08-05,2024-08-09,ACTUAL,,,,2024-08-05,2024-08-09,ACTUAL,2018-03-19,ACTUAL,2018-03-19,2024-08,2024-08-31,2024-01-16,ACTUAL,2024-01-16,2020-09-11,ACTUAL,2020-09-11,,INTERVENTIONAL,,,QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.,NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.,TERMINATED,,PHASE1/PHASE2,9.0,ACTUAL,"ImmunityBio, Inc.",,1.0,,Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention,f,,,,t,t,f,,,,,,,,,,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,INDUSTRY,,,,,,,2024,0.0
NCT04499963,,2020-07-31,2023-08-29,,2023-09-26,2020-07-31,2020-08-05,ACTUAL,2023-09-26,2023-09-28,ACTUAL,,,,2023-09-26,2023-09-28,ACTUAL,2020-08-28,ACTUAL,2020-08-28,2023-09,2023-09-30,2022-08-30,ACTUAL,2022-08-30,2022-08-30,ACTUAL,2022-08-30,,INTERVENTIONAL,,Baseline Characteristics not collected on the healthy control arm.,Trial of Theracurmin for Patients With Amyotrophic Lateral Sclerosis (ALS),"An Open-label, Single-center, 6-month Trial of Theracurmin for Patients With Amyotrophic Lateral Sclerosis (ALS)",COMPLETED,,PHASE2,100.0,ACTUAL,Duke University,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,OTHER,,,,,,,2022,1.0
NCT02785549,,2016-05-25,,,2020-05-13,2016-05-27,2016-05-30,ESTIMATED,,,,,,,2020-05-13,2020-05-14,ACTUAL,2016-11,,2016-11-30,2020-05,2020-05-31,2020-04-01,ACTUAL,2020-04-01,2020-01-12,ACTUAL,2020-01-12,,INTERVENTIONAL,,,Randomized Clinical Trial to Compare the Treatment of Mild Acute Diverticulitis With or Without Antibiotics,"Multicentre Controlled, Randomized Clinical Trial to Compare the Efficacy and Safety of Ambulatory Treatment of Mild Acute Diverticulitis Without Antibiotics With the Standard Treatment With Antibiotics",COMPLETED,,PHASE4,480.0,ACTUAL,Corporacion Parc Tauli,,2.0,,,f,,,,,,,,,,,,,,,UNDECIDED,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,OTHER,,,,,,,2020,1.0
NCT05678881,,2022-12-22,,,2024-05-01,2022-12-22,2023-01-10,ACTUAL,,,,,,,2024-05-01,2024-05-02,ACTUAL,2022-04-25,ACTUAL,2022-04-25,2024-05,2024-05-31,2024-02-23,ACTUAL,2024-02-23,2024-02-23,ACTUAL,2024-02-23,,INTERVENTIONAL,,,"Safety, Tolerability, and Efficacy of RLS103 in a Clinical Model of Photosensitive Epilepsy","A Phase 1b Randomized, Double-Blind, Placebo Controlled, Crossover Study to Evaluate the Safety, Tolerability, and Efficacy of Two Doses of RLS103 (Inhaled Dry Powder Cannabidiol [CBD]) in a Clinical Model of Photosensitive Epilepsy",TERMINATED,,PHASE1,2.0,ACTUAL,Receptor Life Sciences,,3.0,,Lack of enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,INDUSTRY,,,,,,,2024,0.0
NCT03873116,,2019-03-11,2020-11-17,,2024-02-07,2019-03-11,2019-03-13,ACTUAL,2021-02-10,2021-03-04,ACTUAL,,,,2024-02-07,2024-07-19,ACTUAL,2018-12-27,ACTUAL,2018-12-27,2024-02,2024-02-29,2021-07-08,ACTUAL,2021-07-08,2021-07-08,ACTUAL,2021-07-08,,INTERVENTIONAL,APeX-J,,Study to Evaluate the Efficacy and Safety of BCX7353 as an Oral Treatment for the Prevention of HAE Attacks in Japan,"A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX7353 as an Oral Treatment for the Prevention of Attacks in Subjects With Hereditary Angioedema",COMPLETED,,PHASE3,19.0,ACTUAL,BioCryst Pharmaceuticals,,3.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,INDUSTRY,,,,,,,2021,1.0
NCT04262388,,2020-02-05,,,2020-11-13,2020-02-07,2020-02-10,ACTUAL,,,,,,,2020-11-13,2020-11-17,ACTUAL,2021-01,ESTIMATED,2021-01-31,2020-11,2020-11-30,2023-01,ESTIMATED,2023-01-31,2023-01,ESTIMATED,2023-01-31,,INTERVENTIONAL,DOME,,"A Multi-Cancer, Multi-State, Platform Study of Durvalumab (MEDI4736) and Oleclumab (MEDI9447) in Pancreatic Adenocarcinoma, Non-Small Cell Lung Cancer and Squamous Cell Carcinoma of the Head and Neck to Correlate Clinical, Molecular and Immunologic Parameters With DNA Methylation","A Multi-Cancer, Multi-State, Platform Study of Durvalumab (MEDI4736) and Oleclumab (MEDI9447) in Pancreatic Adenocarcinoma, Non-Small Cell Lung Cancer and Squamous Cell Carcinoma of the Head and Neck to Correlate Clinical, Molecular and Immunologic Parameters With DNA Methylation (DOME)",WITHDRAWN,,PHASE2,0.0,ACTUAL,"University Health Network, Toronto",,2.0,,Overall clinical activity (ORR) for oleclumab + durvalumab is minimal across tumor types and does not support further evaluation of this doublet.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,OTHER,,,,,,,2023,0.0
NCT04634253,,2020-11-17,2023-01-05,,2023-06-26,2020-11-17,2020-11-18,ACTUAL,2023-01-05,2023-02-01,ACTUAL,,,,2023-06-26,2023-07-12,ACTUAL,2021-01-04,ACTUAL,2021-01-04,2023-06-01,2023-06-01,2022-06-29,ACTUAL,2022-06-29,2022-01-10,ACTUAL,2022-01-10,,INTERVENTIONAL,,All randomized participants.,A Study of LY3462817 in Participants With Rheumatoid Arthritis,A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants With Moderately to Severely Active Rheumatoid Arthritis,COMPLETED,,PHASE2,98.0,ACTUAL,Eli Lilly and Company,"No adjustment for multiplicity was made. For assessments beyond the primary endpoint, nominal p-values are reported.",3.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting","Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting",http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,INDUSTRY,,,,,,,2022,1.0
NCT05101122,,2021-10-07,2023-03-16,,2023-03-16,2021-10-19,2021-11-01,ACTUAL,2023-03-16,2023-04-07,ACTUAL,,,,2023-03-16,2023-04-07,ACTUAL,2021-10-19,ACTUAL,2021-10-19,2022-10,2022-10-31,2022-04-18,ACTUAL,2022-04-18,2022-04-18,ACTUAL,2022-04-18,,INTERVENTIONAL,SEED,"This analysis was performed according to a modified intention-to-treat procedure, namely after inclusion of all participants who took at least one dose of any study medication and had at least one efficacy measure",Study for Efficacy and Dose Escalation of AD313 + Atomoxetine (SEED),Open-Label 4-Period Dose-Escalation Safety and Efficacy Study of AD313 in Participants With Obstructive Sleep Apnea,COMPLETED,,PHASE1/PHASE2,15.0,ACTUAL,Apnimed,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,INDUSTRY,,,,,,,2022,1.0
NCT05038982,,2021-08-23,2023-05-08,,2023-06-12,2021-09-02,2021-09-09,ACTUAL,2023-06-12,2023-07-03,ACTUAL,,,,2023-06-12,2023-07-03,ACTUAL,2021-09-09,ACTUAL,2021-09-09,2023-06,2023-06-30,2022-07-11,ACTUAL,2022-07-11,2022-07-11,ACTUAL,2022-07-11,,INTERVENTIONAL,,,Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin,"Efficacy, Safety, and Tolerability of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin",COMPLETED,,PHASE2,20.0,ACTUAL,Johns Hopkins University,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,OTHER,,,,,,,2022,1.0
NCT04030143,,2019-07-19,2023-09-22,2021-06-16,2023-10-27,2019-07-19,2019-07-23,ACTUAL,2023-10-27,2023-11-18,ACTUAL,,2023-11-18,ACTUAL,2023-10-27,2023-11-18,ACTUAL,2019-08-01,ACTUAL,2019-08-01,2023-10,2023-10-31,2020-07-08,ACTUAL,2020-07-08,2020-07-08,ACTUAL,2020-07-08,,INTERVENTIONAL,,Randomized sample consisted of all participants who were randomized.,A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder,"A Phase 1b, Open-label, Multiple-dose, Randomized, Parallel-arm, Safety, Tolerability, and Pharmacokinetic Trial of Aripiprazole Intramuscular Depot Administered in the Gluteal Muscle in Adult Subjects With Schizophrenia or Bipolar I Disorder",COMPLETED,,PHASE1/PHASE2,266.0,ACTUAL,"Otsuka Pharmaceutical Development & Commercialization, Inc.",,2.0,,,f,,,,f,t,f,,,,,,"Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.",Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com,https://clinical-trials.otsuka.com,YES,Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,INDUSTRY,,,,,,,2020,1.0
NCT04682366,,2020-12-18,2023-09-28,,2024-01-29,2020-12-18,2020-12-23,ACTUAL,2024-01-29,2024-01-31,ACTUAL,,,,2024-01-29,2024-01-31,ACTUAL,2021-10-19,ACTUAL,2021-10-19,2022-10,2022-10-31,2022-11-10,ACTUAL,2022-11-10,2022-11-10,ACTUAL,2022-11-10,,INTERVENTIONAL,,2 Subjects were Lost To Follow - 1 in each Group,The Effect of Tamsulosin on Postoperative Urinary Retention,Evaluating the Effect of Tamsulosin on Postoperative Urinary Retention in Women Undergoing Same Day Hospital Discharge Following Pelvic Reconstructive Surgery: A Randomized Trial,TERMINATED,,PHASE4,4.0,ACTUAL,Wake Forest University Health Sciences,,2.0,,Challenges in enrollment led to decission for termination,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,OTHER,,,,,,,2022,0.0
NCT03821402,,2019-01-15,2023-06-02,2020-12-22,2023-08-25,2019-01-28,2019-01-29,ACTUAL,2023-08-25,2023-09-21,ACTUAL,,2023-09-21,ACTUAL,2023-08-25,2023-09-21,ACTUAL,2018-12-12,ACTUAL,2018-12-12,2023-08,2023-08-31,2020-11-23,ACTUAL,2020-11-23,2020-11-23,ACTUAL,2020-11-23,,INTERVENTIONAL,JUNIPER,Safety population,Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury",COMPLETED,,PHASE2,83.0,ACTUAL,"Revance Therapeutics, Inc.",,4.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,INDUSTRY,,,,,,,2020,1.0
NCT04879589,,2021-04-26,,,2023-04-26,2021-05-04,2021-05-10,ACTUAL,,,,,,,2023-04-26,2023-04-28,ACTUAL,2022-09-01,ACTUAL,2022-09-01,2022-04,2022-04-30,2023-04-20,ACTUAL,2023-04-20,2023-04-20,ACTUAL,2023-04-20,,INTERVENTIONAL,,,Phase 1 Study of ATRS-2002 in Healthy Male Adults,"Phase 1, Open-Label, Single-Ascending Dose, Parallel Group Study to Determine the Pharmacokinetics, Safety, and Tolerability of ATRS-2002 Administered Subcutaneously in Healthy Adult Males",WITHDRAWN,,PHASE1,0.0,ACTUAL,Syneos Health,,2.0,,"Study abandoned, no participants enrolled",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,OTHER,,,,,,,2023,0.0
NCT01972217,,2013-10-24,2018-09-06,,2023-11-10,2013-10-24,2013-10-30,ESTIMATED,2018-09-06,2018-10-02,ACTUAL,,,,2023-11-10,2023-11-14,ACTUAL,2014-04-01,ACTUAL,2014-04-01,2023-10,2023-10-31,2023-08-24,ACTUAL,2023-08-24,2017-09-22,ACTUAL,2017-09-22,,INTERVENTIONAL,,The Safety analysis set consisted of all patients who received at least 1 dose of study treatment in Part A and all patients randomised into Part B of the study who received at least 1 dose of study treatment.,Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer.,"A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatment in Patients With Metastatic Castrate-Resistant Prostate Cancer Who Have Received Prior Chemotherapy Containing Docetaxel",COMPLETED,,PHASE2,158.0,ACTUAL,AstraZeneca,,2.0,,,f,,,,f,,,,,,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,INDUSTRY,,,,,,,2023,1.0
NCT04335006,,2020-03-31,,,2023-05-04,2020-04-02,2020-04-06,ACTUAL,,,,,,,2023-05-04,2023-05-06,ACTUAL,2020-07-14,ACTUAL,2020-07-14,2023-05,2023-05-31,2023-04-14,ACTUAL,2023-04-14,2023-04-14,ACTUAL,2023-04-14,,INTERVENTIONAL,,,"A Phase 3 Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer.","A Multicentre, Open-parallel, Randomized, Controlled Phase Ⅲ Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer.",TERMINATED,,PHASE3,80.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,3.0,,Sponsor R \& D Strategy Adjustment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,INDUSTRY,,,,,,,2023,0.0
NCT03982121,,2019-06-07,,,2020-02-12,2019-06-07,2019-06-11,ACTUAL,,,,,,,2020-02-12,2020-02-17,ACTUAL,2019-06-04,ACTUAL,2019-06-04,2020-02,2020-02-29,2020-02-12,ACTUAL,2020-02-12,2020-02-12,ACTUAL,2020-02-12,,INTERVENTIONAL,ISILI,,Study of Intratumoral Ipilimumab and TLR4 Agonist GLA-SE in Combination With Systemic Nivolumab and Chemotherapy,"ISILI (In Situ Immunotherapy of LIver Metastases): An Openlabel, Dose-finding, Phase I Study of Intratumoral Ipilimumab and TLR4 Agonist GLA-SE in Combination With Systemic Nivolumab and Chemotherapy (FOLFOX Regimen) in Patients With Colorectal Liver Metastases.",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Gustave Roussy, Cancer Campus, Grand Paris",,6.0,,Study never began because of withdrawal of the industrial partner,f,,,,f,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,OTHER,,,,,,,2020,0.0
NCT02458313,,2015-05-21,2023-02-21,,2023-05-17,2015-05-27,2015-06-01,ESTIMATED,2023-05-17,2023-06-12,ACTUAL,,,,2023-05-17,2023-06-12,ACTUAL,2016-04-14,ACTUAL,2016-04-14,2023-05,2023-05-31,2021-12-13,ACTUAL,2021-12-13,2021-12-13,ACTUAL,2021-12-13,,INTERVENTIONAL,,,Nicotinic Agonist Effects on BMI and Neuronal Response,Nicotinic Agonist Effects on BMI and Neuronal Response in Overweight/Obese Adults,COMPLETED,,PHASE1,61.0,ACTUAL,"University of Colorado, Denver",,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,OTHER,,,,,,,2021,1.0
NCT02798627,,2016-05-17,2021-04-03,,2021-05-19,2016-06-08,2016-06-14,ESTIMATED,2021-05-19,2021-05-24,ACTUAL,,,,2021-05-19,2021-05-24,ACTUAL,2016-05,,2016-05-31,2021-05,2021-05-31,2020-10,ACTUAL,2020-10-31,2020-03,ACTUAL,2020-03-31,,INTERVENTIONAL,,,Trial Of NS2359 For The Treatment of Cocaine Dependence,"A Phase II, Double-Blind, Placebo-Controlled, Trial Of NS2359 For The Treatment of Cocaine Dependence",COMPLETED,,PHASE2,55.0,ACTUAL,University of Pennsylvania,Small numbers of individuals analyzed. Some noncompliance per plasma NS2359 levels at mid and end treatment.,2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,OTHER,,,,,,,2020,1.0
NCT05082116,,2021-09-21,2023-12-26,,2023-12-26,2021-10-05,2021-10-18,ACTUAL,2023-12-26,2024-01-18,ACTUAL,,,,2023-12-26,2024-01-18,ACTUAL,2021-09-27,ACTUAL,2021-09-27,2023-12,2023-12-31,2022-12-28,ACTUAL,2022-12-28,2022-12-28,ACTUAL,2022-12-28,,INTERVENTIONAL,Pathfinder10,Results were based on the full analysis set (FAS) which included all participants exposed to N8-GP in this trial.,Efficacy and Safety of Turoctocog Alfa Pegol (N8-GP) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (pathfinder10),"A Multi-centre, Open-label Trial Evaluating Efficacy, Safety and Pharmacokinetics of Turoctocog Alfa Pegol (N8-GP) When Used for Treatment and Prophylaxis of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A",COMPLETED,,PHASE3,36.0,ACTUAL,Novo Nordisk A/S,,1.0,,,f,,,,f,t,f,,,t,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials.com,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,INDUSTRY,,,,,,,2022,1.0
NCT01942837,,2013-09-04,2022-03-30,,2022-10-20,2013-09-11,2013-09-16,ESTIMATED,2022-06-08,2022-07-05,ACTUAL,,,,2022-10-20,2022-10-24,ACTUAL,2013-09-13,ACTUAL,2013-09-13,2022-10,2022-10-31,2022-09-30,ACTUAL,2022-09-30,2021-12,ACTUAL,2021-12-31,,INTERVENTIONAL,,Patients who received ≥1 dose of enzalutamide. Two patients didn't initiate the treatment.,Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer,Phase II Trial of Enzalutamide for Castrate-resistant Prostate Cancer (CRPC) With Correlative Assessment of Androgen Receptor (AR) Signaling and Whole-exome and Transcriptome Sequencing,COMPLETED,,PHASE2,67.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,OTHER,,,,,,,2022,1.0
NCT03149679,,2017-03-14,,,2021-01-20,2017-05-09,2017-05-11,ACTUAL,,,,,,,2021-01-20,2021-01-22,ACTUAL,2017-05-09,ACTUAL,2017-05-09,2020-02,2020-02-29,2020-08-07,ACTUAL,2020-08-07,2020-08-07,ACTUAL,2020-08-07,,INTERVENTIONAL,,,The p53 Colorectal Cancer Trial,Treatment of Patients With Metastatic Colorectal Cancer Harboring TP53 Mutations With Dose-dense Cyclophosphamide - the p53 Colorectal Cancer Trial,TERMINATED,,PHASE2,12.0,ACTUAL,Haukeland University Hospital,,1.0,,The study was discontinued after the first pre-planned interim analysis due to insufficient response rates.,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,OTHER,,,,,,,2020,0.0
NCT04720664,,2020-12-14,2023-03-15,,2023-08-25,2021-01-20,2021-01-22,ACTUAL,2023-08-25,2023-08-28,ACTUAL,,,,2023-08-25,2023-08-28,ACTUAL,2021-09-22,ACTUAL,2021-09-22,2023-03,2023-03-31,2023-02-10,ACTUAL,2023-02-10,2023-02-10,ACTUAL,2023-02-10,,INTERVENTIONAL,OASIS,,Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer,OASIS: Phase II Trial of OrAl SM-88 in Patients With Metastatic Hormone Receptor-posItive HER2-negative (HR+/HER2-) breaSt Cancer,TERMINATED,,PHASE2,11.0,ACTUAL,Georgetown University,,1.0,,Lack of efficacy,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,OTHER,,,,,,,2023,0.0
NCT02856568,,2016-07-14,,,2017-05-25,2016-08-02,2016-08-05,ESTIMATED,,,,,,,2017-05-25,2017-05-30,ACTUAL,2017-05-01,ACTUAL,2017-05-01,2017-05,2017-05-31,2021-10,ESTIMATED,2021-10-31,2021-10,ESTIMATED,2021-10-31,,INTERVENTIONAL,,,"Ricolinostat, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable or Metastatic Cholangiocarcinoma","A Phase Ib, Open-Label, Dose- Escalation Trial of ACY-1215 in Combination With Gemcitabine and Cisplatin in Patients With Unresectable or Metastatic Cholangiocarcinoma",WITHDRAWN,,PHASE1,0.0,ACTUAL,Mayo Clinic,,1.0,,Site dropped study,f,,,,,t,f,,,,,,,,,,,2024-10-15 05:16:19.070079,2024-10-15 05:16:19.070079,OTHER,,,,,,,2021,0.0
NCT02917122,,2016-06-30,2021-08-26,,2021-09-22,2016-09-27,2016-09-28,ESTIMATED,2021-09-22,2021-10-20,ACTUAL,,,,2021-09-22,2021-10-20,ACTUAL,2015-08,,2015-08-31,2021-09,2021-09-30,2021-08,ACTUAL,2021-08-31,2021-08,ACTUAL,2021-08-31,,INTERVENTIONAL,Parkinson's,,The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease,The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease,TERMINATED,,PHASE1/PHASE2,15.0,ACTUAL,National Cheng-Kung University Hospital,,2.0,,Funding is insufficient.,f,,,,t,,,,,,,,,,,NO,,2024-10-15 05:21:53.559112,2024-10-15 05:21:53.559112,OTHER,,,,,,,2021,0.0
NCT02066181,,2014-02-17,2019-03-22,,2023-06-06,2014-02-17,2014-02-19,ESTIMATED,2019-08-28,2019-09-20,ACTUAL,,,,2023-06-06,2023-06-07,ACTUAL,2014-03-21,ACTUAL,2014-03-21,2023-06,2023-06-30,2022-12-01,ACTUAL,2022-12-01,2019-07-03,ACTUAL,2019-07-03,,INTERVENTIONAL,,,Sorafenib Tosylate in Treating Patients With Desmoid Tumors or Aggressive Fibromatosis,"A Phase III, Double Blind, Randomized, Placebo-Controlled Trial of Sorafenib in Desmoid Tumors or Aggressive Fibromatosis (DT/DF)",COMPLETED,,PHASE3,87.0,ACTUAL,National Cancer Institute (NCI),,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 05:21:53.559112,2024-10-15 05:21:53.559112,NIH,,,,,,,2022,1.0
NCT03771664,,2018-12-07,2022-08-31,2021-10-08,2023-11-27,2018-12-07,2018-12-11,ACTUAL,2022-10-13,2022-10-20,ACTUAL,2022-10-13,2022-10-20,ACTUAL,2023-11-27,2023-11-29,ACTUAL,2019-02-04,ACTUAL,2019-02-04,2023-11,2023-11-30,2020-01-17,ACTUAL,2020-01-17,2019-12-20,ACTUAL,2019-12-20,,INTERVENTIONAL,,Safety set included all participants who received at least 1 dose of double-blind study drug.,"A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia","A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Subjects With Comorbid Major Depressive Disorder and Insomnia",TERMINATED,,PHASE3,87.0,ACTUAL,Biogen,The study was terminated early due to sponsor's decision and there were no safety concerns.,2.0,,internal company decision,f,,,,f,t,f,,,,,,,,https://vivli.org/,YES,In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/,2024-10-15 05:21:53.559112,2024-10-15 05:21:53.559112,INDUSTRY,,,,,,,2020,0.0
NCT04983446,,2021-07-14,,,2022-10-18,2021-07-28,2021-07-30,ACTUAL,,,,,,,2022-10-18,2022-10-19,ACTUAL,2022-04-30,ESTIMATED,2022-04-30,2022-10,2022-10-31,2022-12-30,ESTIMATED,2022-12-30,2022-10-30,ESTIMATED,2022-10-30,,INTERVENTIONAL,,,In-patient COVID-19 Study of Intranasal Foralumab,"A Phase 2 Proof-of-concept Study to Evaluate the Safety, Tolerability, and Efficacy of Intranasal Foralumab in Hospitalized Subjects With Severe COVID-19 and Pulmonary Inflammation",WITHDRAWN,,PHASE2,0.0,ACTUAL,Tiziana Life Sciences LTD,,2.0,,Withdrawn due to business reasons,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 05:21:53.559112,2024-10-15 05:21:53.559112,INDUSTRY,,,,,,,2022,0.0
NCT03112603,,2017-04-04,2021-12-10,2021-05-04,2023-07-17,2017-04-07,2017-04-13,ACTUAL,2022-03-22,2022-04-15,ACTUAL,2022-03-22,2022-04-15,ACTUAL,2023-07-17,2023-07-18,ACTUAL,2017-06-29,ACTUAL,2017-06-29,2023-07,2023-07-31,2022-12-15,ACTUAL,2022-12-15,2020-05-08,ACTUAL,2020-05-08,,INTERVENTIONAL,,,A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3),A Phase III Randomized Open-label Multi-center Study of Ruxolitinib vs. Best Available Therapy in Patients With Corticosteroid-refractory Chronic Graft vs Host Disease After Allogeneic Stem Cell Transplantation (REACH3),COMPLETED,,PHASE3,330.0,ACTUAL,Incyte Corporation,,2.0,,,t,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:21:53.559112,2024-10-15 05:21:53.559112,INDUSTRY,,NCT03147742,APPROVED_FOR_MARKETING,,,,2022,1.0
NCT03085095,,2017-03-09,2021-01-19,2020-10-05,2022-01-06,2017-03-14,2017-03-21,ACTUAL,2021-03-02,2021-03-25,ACTUAL,2021-03-02,2021-03-25,ACTUAL,2022-01-06,2022-01-18,ACTUAL,2017-04-18,ACTUAL,2017-04-18,2022-01,2022-01-31,2021-11-26,ACTUAL,2021-11-26,2019-10-25,ACTUAL,2019-10-25,,INTERVENTIONAL,HERO,All randomized participants who received at least 1 dose of study drug in the primary analysis part of the study.,A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer,"HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer",COMPLETED,,PHASE3,1134.0,ACTUAL,Myovant Sciences GmbH,,2.0,,,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 05:21:53.559112,2024-10-15 05:21:53.559112,INDUSTRY,,,,,,,2021,1.0
NCT04058964,,2019-08-14,,,2020-03-11,2019-08-14,2019-08-16,ACTUAL,,,,,,,2020-03-11,2020-03-13,ACTUAL,2020-02-01,ESTIMATED,2020-02-01,2020-03,2020-03-31,2022-10-31,ESTIMATED,2022-10-31,2022-10-31,ESTIMATED,2022-10-31,,INTERVENTIONAL,,,Pembrolizumab and PEGPH20 in Treating Patients With Metastatic Pancreatic Cancer,A Pilot Study to Assess the Efficacy and Safety Effects of Pembrolizumab and PEGPH20 (Pegvorhyaluronidase Alfa) in Patients With Metastatic Pancreatic Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Study withdrawn by supporter,f,,,,f,t,f,,,,,,,,,,,2024-10-15 05:21:53.559112,2024-10-15 05:21:53.559112,OTHER,,,,,,,2022,0.0
NCT03536208,,2018-03-28,,,2021-03-23,2018-05-14,2018-05-24,ACTUAL,,,,,,,2021-03-23,2021-03-25,ACTUAL,2019-05-15,ACTUAL,2019-05-15,2021-03,2021-03-31,2022-06,ESTIMATED,2022-06-30,2021-06,ESTIMATED,2021-06-30,,INTERVENTIONAL,,,Biological Effect of Warfarin on Pancreatic Cancer,Biological Effect of Warfarin on Pancreatic Cancer,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,University of Texas Southwestern Medical Center,,1.0,,no accrual for over 12 months,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 05:21:53.559112,2024-10-15 05:21:53.559112,OTHER,,,,,,,2022,0.0
NCT02989597,,2016-12-07,2023-03-02,2022-01-20,2023-04-24,2016-12-08,2016-12-12,ESTIMATED,2023-04-03,2023-04-25,ACTUAL,2022-02-12,2022-02-15,ACTUAL,2023-04-24,2023-05-22,ACTUAL,2017-07-29,ACTUAL,2017-07-29,2023-04,2023-04-30,2020-11-10,ACTUAL,2020-11-10,2020-11-10,ACTUAL,2020-11-10,,INTERVENTIONAL,MAPS,,Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients,Single-dose Intraoperative Methadone for Early Ambulation and Sustained Pain Control in Spinal Fusion Surgery Patients,TERMINATED,,PHASE4,10.0,ACTUAL,Montefiore Medical Center,,2.0,,Due to personnel loss and logistical issues the study was unable to be completed as planned.,f,,,,t,t,f,,,f,,,,,,,,2024-10-15 05:21:53.559112,2024-10-15 05:21:53.559112,OTHER,,,,,,,2020,0.0
NCT04885907,,2021-05-09,,,2022-07-29,2021-05-09,2021-05-13,ACTUAL,,,,,,,2022-07-29,2022-08-02,ACTUAL,2021-05-25,ACTUAL,2021-05-25,2022-07,2022-07-31,2021-08-30,ACTUAL,2021-08-30,2021-07-30,ACTUAL,2021-07-30,,INTERVENTIONAL,,,Third Dose of Moderna COVID-19 Vaccine in Transplant Recipients,"A Randomised, Blinded, Controlled Trial of a Third Dose of Moderna COVID-19 Vaccine Versus Placebo in Solid Organ Transplant Recipients",COMPLETED,,PHASE4,120.0,ACTUAL,"University Health Network, Toronto",,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 05:21:53.559112,2024-10-15 05:21:53.559112,OTHER,,,,,,,2021,1.0
NCT03822117,,2019-01-28,2023-02-16,,2023-03-16,2019-01-28,2019-01-30,ACTUAL,2023-02-16,2023-03-15,ACTUAL,,,,2023-03-16,2023-03-20,ACTUAL,2019-10-17,ACTUAL,2019-10-17,2023-03,2023-03-31,2022-03-29,ACTUAL,2022-03-29,2022-03-29,ACTUAL,2022-03-29,,INTERVENTIONAL,,,Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207),"A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)",TERMINATED,,PHASE2,111.0,ACTUAL,Incyte Corporation,,1.0,,A business decision was made to to discontinue further enrollment. There were no safety concerns that contributed to this decision.,t,,,,t,t,f,,,,,,Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.,"Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.",https://www.incyte.com/our-company/compliance-and-transparency,YES,Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency,2024-10-15 05:21:53.559112,2024-10-15 05:21:53.559112,INDUSTRY,,NCT03906357,NO_LONGER_AVAILABLE,,,,2022,0.0
NCT02668653,,2016-01-22,2022-08-12,,2024-08-02,2016-01-28,2016-01-29,ESTIMATED,2022-09-27,2022-10-05,ACTUAL,,,,2024-08-02,2024-08-06,ACTUAL,2016-09-01,ACTUAL,2016-09-01,2024-07,2024-07-31,2023-06-16,ACTUAL,2023-06-16,2021-08-13,ACTUAL,2021-08-13,,INTERVENTIONAL,QuANTUM-First,Demographic and baseline characteristics were assessed in the Intent-to-Treat Analysis Set.,Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML),"A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)",COMPLETED,,PHASE3,539.0,ACTUAL,Daiichi Sankyo,,2.0,,,f,,,,t,t,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-15 05:21:53.559112,2024-10-15 05:21:53.559112,INDUSTRY,,,,,,,2023,1.0
NCT05338346,,2022-04-14,,,2024-07-17,2022-04-14,2022-04-21,ACTUAL,,,,,,,2024-07-17,2024-07-18,ACTUAL,2022-07-08,ACTUAL,2022-07-08,2024-07,2024-07-31,2024-01-08,ACTUAL,2024-01-08,2024-01-08,ACTUAL,2024-01-08,,INTERVENTIONAL,ATRIUM,,A Study of ATG-018 (ATR Inhibitor) Treatment in Patients With Advanced Solid Tumors and Hematological Malignancies,"A Phase I, Open-Label, Multi-Center, Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG-018 (ATR Inhibitor) Treatment in Patients With Advanced Solid Tumors and Hematological Malignancies",TERMINATED,,PHASE1,22.0,ACTUAL,Antengene Corporation,,1.0,,Lack of efficacy of study compound,f,,,,,f,f,,,,,,,,,,,2024-10-15 05:21:53.559112,2024-10-15 05:21:53.559112,INDUSTRY,,,,,,,2024,0.0
NCT04894266,,2021-05-05,,,2023-11-14,2021-05-18,2021-05-20,ACTUAL,,,,,,,2023-11-14,2023-11-18,ACTUAL,2022-01-14,ACTUAL,2022-01-14,2023-11,2023-11-30,2022-06-22,ACTUAL,2022-06-22,2022-06-22,ACTUAL,2022-06-22,,INTERVENTIONAL,,,An Open-Label Study of Apabetalone in Covid Infection,An Open-Label Study to Assess the Safety and Effect on Clinical Course and Key Biomarkers of Oral Apabetalone in Hospitalized Subjects With Covid-19 Infection in Addition to Standard of Care (SOC),TERMINATED,,PHASE2/PHASE3,1.0,ACTUAL,Resverlogix Corp,,2.0,,Unable to recruit subjects,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:21:53.559112,2024-10-15 05:21:53.559112,INDUSTRY,,,,,,,2022,0.0
NCT03738215,,2018-11-08,2022-09-29,,2022-09-29,2018-11-08,2018-11-13,ACTUAL,2022-09-29,2022-10-25,ACTUAL,,,,2022-09-29,2022-10-25,ACTUAL,2018-11-09,ACTUAL,2018-11-09,2022-09,2022-09-30,2021-09-30,ACTUAL,2021-09-30,2021-09-30,ACTUAL,2021-09-30,,INTERVENTIONAL,,Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.,"Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone","A Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to Antidepressants Alone",COMPLETED,,PHASE3,759.0,ACTUAL,AbbVie,,3.0,,,f,,,,f,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,INDUSTRY,,,,,,,2021,1.0
NCT04546672,,2020-09-05,2024-06-18,,2024-07-25,2020-09-05,2020-09-14,ACTUAL,2024-07-25,2024-07-29,ACTUAL,,,,2024-07-25,2024-07-29,ACTUAL,2021-03-16,ACTUAL,2021-03-16,2024-07,2024-07-31,2023-08-13,ACTUAL,2023-08-13,2023-06-14,ACTUAL,2023-06-14,,INTERVENTIONAL,STIM_Bowel,,Sugammadex To IMprove Bowel Function,"An Assessor-blinded, Randomized, Controlled, Single Center, Parallel Design Trial With Patient Masking to Compare Early Postoperative Gastric Emptying Associated With Rocuronium Neuromuscular Reversal With Sugammadex Versus Neostigmine in Adults Undergoing Colon and Rectal Surgery",COMPLETED,,PHASE4,120.0,ACTUAL,Oregon Health and Science University,,2.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 05:21:53.559112,2024-10-15 05:21:53.559112,OTHER,,,,,,,2023,1.0
NCT03038100,,2017-01-30,2023-01-09,,2023-02-15,2017-01-30,2017-01-31,ESTIMATED,2023-02-15,2023-02-17,ACTUAL,,,,2023-02-15,2023-02-17,ACTUAL,2017-03-08,ACTUAL,2017-03-08,2023-02,2023-02-28,2022-08-12,ACTUAL,2022-08-12,2022-02-08,ACTUAL,2022-02-08,,INTERVENTIONAL,IMagyn050,,"A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer",COMPLETED,,PHASE3,1301.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,,,,,,2022,1.0
NCT04586439,,2020-10-12,,,2021-03-04,2020-10-12,2020-10-14,ACTUAL,,,,,,,2021-03-04,2021-03-08,ACTUAL,2020-11-24,ACTUAL,2020-11-24,2021-03,2021-03-31,2021-02-18,ACTUAL,2021-02-18,2021-02-18,ACTUAL,2021-02-18,,INTERVENTIONAL,,,A Study of JNJ-73763989 in Healthy Chinese Adult Participants,"A Randomized, Open-Label, Parallel, Single Dose Study to Investigate Pharmacokinetics, Safety, and Tolerability of JNJ-73763989 in Healthy Chinese Adult Participants",COMPLETED,,PHASE1,18.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,,f,,,,f,t,f,,,t,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,,,,,,2021,1.0
NCT04476797,,2020-07-15,2024-03-05,,2024-04-02,2020-07-15,2020-07-20,ACTUAL,2024-03-05,2024-04-03,ACTUAL,,,,2024-04-02,2024-04-30,ACTUAL,2020-10-18,ACTUAL,2020-10-18,2023-12,2023-12-31,2023-11-28,ACTUAL,2023-11-28,2023-11-28,ACTUAL,2023-11-28,,INTERVENTIONAL,GRECO-1,,Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC,"GRECO-1: Phase I/II, Randomized, Placebo-Controlled Study of Stereotactic Body Radiation Therapy (SBRT) and GC4711 for Centrally Located or Large, Node-Negative Non-Small Cell Lung Cancer (NSCLC)",TERMINATED,,PHASE1/PHASE2,47.0,ACTUAL,"Galera Therapeutics, Inc.",Study was terminated early by the Sponsor based on a the results of a futility analysis that was conducted on another program and the Sponsor decided to terminate the develop of GC4711. The last randomized subject did not complete protocol therapy but was followed for safety for a period of 30 days post the last administration of GC4711/Placebo +SBRT.,3.0,,Development GC4711 was halted after the lead study in pancreatic cancer was stopped early due to meeting the requirements of a futility analysis,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,,,,,,2023,0.0
NCT05200403,,2022-01-07,,,2024-03-27,2022-01-07,2022-01-20,ACTUAL,,,,,,,2024-03-27,2024-03-29,ACTUAL,2022-07-26,ACTUAL,2022-07-26,2024-03,2024-03-31,2024-02-15,ACTUAL,2024-02-15,2024-02-15,ACTUAL,2024-02-15,,INTERVENTIONAL,PAD,,Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis,"Quantification of Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis on Crisaborole Ointment, 2%",TERMINATED,,PHASE4,118.0,ACTUAL,Boston University,,2.0,,Funding was stoppped by grantor.,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,OTHER,,,,,,,2024,0.0
NCT04237116,,2020-01-20,2022-06-10,,2024-02-27,2020-01-20,2020-01-23,ACTUAL,2023-06-14,2024-02-08,ACTUAL,,,,2024-02-27,2024-02-29,ACTUAL,2020-02-19,ACTUAL,2020-02-19,2024-02,2024-02-29,2021-07-23,ACTUAL,2021-07-23,2021-06-29,ACTUAL,2021-06-29,,INTERVENTIONAL,pINPOINt,Full Analysis Set,A Study of Secukinumab Treatment in Patients With Plaque Psoriasis and Coexisting Non-alcoholic Fatty Liver Disease (NAFLD),"A Randomized, Double-blind, Multicenter, 24-week Study of Subcutaneous Secukinumab to Assess Anti-interleukin-17A Treatment in Plaque Psoriasis Patients With Coexisting Non-alcoholic Fatty Liver Disease (pINPOINt)",TERMINATED,,PHASE3,10.0,ACTUAL,Novartis,"Due to premature termination and limited number of treated patients (7 for secukinumab group and 3 in placebo), the extent of originally planned statistical analyses of efficacy was limited to descriptive summaries (absolute values per visit and changes from baseline; presented as mean and standard deviation) for the PASI score, ALT values, and DLQI scores.",2.0,,Low enrollment,f,,,,f,f,f,,,,,,,,,YES,Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,,,,,,2021,0.0
NCT02392637,,2015-03-13,2021-09-01,,2022-01-05,2015-03-18,2015-03-19,ESTIMATED,2022-01-05,2022-02-02,ACTUAL,,,,2022-01-05,2022-02-02,ACTUAL,2015-04-02,ACTUAL,2015-04-02,2022-01,2022-01-31,2020-08-13,ACTUAL,2020-08-13,2020-08-13,ACTUAL,2020-08-13,,INTERVENTIONAL,,Intent to treat participants,"Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers","A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers",COMPLETED,,PHASE2,62.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,f,t,,,,,,,,,,,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,OTHER,,,,,,,2020,1.0
NCT03780166,,2018-12-17,,,2019-09-11,2018-12-17,2018-12-19,ACTUAL,,,,,,,2019-09-11,2019-09-13,ACTUAL,2019-03,ESTIMATED,2019-03-31,2019-09,2019-09-30,2020-11,ESTIMATED,2020-11-30,2020-11,ESTIMATED,2020-11-30,,INTERVENTIONAL,,,A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris,A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris,WITHDRAWN,,PHASE2,0.0,ACTUAL,Incyte Corporation,,1.0,,The study was withdrawn due to insufficient interest in study participation due to recent approval in this rare condition.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,,,,,,2020,0.0
NCT05461209,,2022-07-13,,,2024-05-24,2022-07-13,2022-07-18,ACTUAL,,,,,,,2024-05-24,2024-05-28,ACTUAL,2022-10-20,ACTUAL,2022-10-20,2024-05,2024-05-31,2022-11-15,ACTUAL,2022-11-15,2022-11-15,ACTUAL,2022-11-15,,INTERVENTIONAL,MonumenTAL-5,,A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma,"A Phase 3 Study Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma Who Have Received at Least 4 Prior Therapies Including an Immunomodulatory Drug, a Proteasome Inhibitor, and an Anti-CD38 Antibody",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Janssen Research & Development, LLC",,2.0,,Business Decision,t,,,,t,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,NCT05503550,NO_LONGER_AVAILABLE,,,,2022,0.0
NCT03841604,,2019-01-30,2022-01-19,,2022-07-21,2019-02-13,2019-02-15,ACTUAL,2022-07-21,2023-05-22,ACTUAL,,,,2022-07-21,2023-05-22,ACTUAL,2019-04-09,ACTUAL,2019-04-09,2020-05,2020-05-31,2021-05-03,ACTUAL,2021-05-03,2021-04-30,ACTUAL,2021-04-30,,INTERVENTIONAL,,Safety Set: all randomised subjects assigned to study intervention and who took at least 1 dose of study intervention.,Effect of Safinamide on Parkinson's Disease Related Chronic Pain,"A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic Pain",COMPLETED,,PHASE4,94.0,ACTUAL,Zambon SpA,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,,,,,,2021,1.0
NCT05169008,,2021-12-10,,,2023-06-14,2021-12-10,2021-12-23,ACTUAL,,,,,,,2023-06-14,2023-06-15,ACTUAL,2022-02-25,ACTUAL,2022-02-25,2022-01,2022-01-31,2023-01-13,ACTUAL,2023-01-13,2023-01-13,ACTUAL,2023-01-13,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Immunogenicity of Ad5-nCoV and Ad5-nCoV-IH in CoronaVac Immunized Children and Adolescents,"A Multicenter, Randomized, and Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of Intramuscular and Inhaled COVID-19 Vaccine in Children Aged 6-12 Years and Adolescents Aged 13-17 Years Who Have Been Immunized With Two Doses of CoronaVac",TERMINATED,,PHASE3,91.0,ACTUAL,CanSino Biologics Inc.,,1.0,,"Difficulty recruiting subjects, so the study was terminated.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,,,,,,2023,0.0
NCT04292899,,2020-02-28,2020-12-15,,2020-12-15,2020-02-28,2020-03-03,ACTUAL,2020-12-15,2020-12-31,ACTUAL,,,,2020-12-15,2020-12-31,ACTUAL,2020-03-06,ACTUAL,2020-03-06,2020-12,2020-12-31,2020-06-30,ACTUAL,2020-06-30,2020-04-09,ACTUAL,2020-04-09,,INTERVENTIONAL,,Part A: Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment.~Part B: Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study treatment.,Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19),A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe COVID-19,COMPLETED,,PHASE3,4891.0,ACTUAL,Gilead Sciences,,4.0,,,t,,,,t,t,f,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.",2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,NCT04323761,APPROVED_FOR_MARKETING,,,,2020,1.0
NCT05442788,,2022-06-22,,,2022-07-03,2022-06-28,2022-07-05,ACTUAL,,,,,,,2022-07-03,2022-07-07,ACTUAL,2021-09-02,ACTUAL,2021-09-02,2022-07,2022-07-31,2022-05-31,ACTUAL,2022-05-31,2022-05-31,ACTUAL,2022-05-31,,INTERVENTIONAL,,,A Study of HB0017 in Patients With Moderate to Severe Plaque Psoriasis,"A Phase Ib, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0017 Following Multiple Dose in Patients With Moderate to Severe Plaque Psoriasis",COMPLETED,,PHASE1,30.0,ACTUAL,"Huabo Biopharm Co., Ltd.",,3.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,,,,,,2022,1.0
NCT04596267,,2020-10-15,2023-10-12,,2023-11-09,2020-10-15,2020-10-22,ACTUAL,2023-11-09,2023-12-04,ACTUAL,,,,2023-11-09,2023-12-04,ACTUAL,2021-09-13,ACTUAL,2021-09-13,2023-11,2023-11-30,2023-02-03,ACTUAL,2023-02-03,2023-02-03,ACTUAL,2023-02-03,,INTERVENTIONAL,,,Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers,The Effects of the Histamine-3 Receptor Inverse Agonist Pitolisant on Alcohol Self-Administration in Heavy Drinkers,TERMINATED,,PHASE1,9.0,ACTUAL,Boston Medical Center,"Recruitment was impacted by COVID-19 restrictions on human subject research, leading to a smaller number of subjects analyzed than planned. This study start date was also delayed due to problems securing the medication supply.",2.0,,Study funding was exhausted prior to reaching the recruitment goal due to pandemic related delays,f,,,,f,t,f,,,f,,,,,,NO,Deidentified data from this study will be submitted to the NIAAA Data archive (https://nda.nih.gov/).,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,OTHER,,,,,,,2023,0.0
NCT03986086,,2019-06-12,,,2020-03-18,2019-06-12,2019-06-14,ACTUAL,,,,,,,2020-03-18,2020-03-20,ACTUAL,2021-09,ESTIMATED,2021-09-30,2020-03,2020-03-31,2023-12,ESTIMATED,2023-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,MPH966 for Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation,"A Phase 1/2 Study of MPH966, an Oral Neutrophil Elastase Inhibitor, for Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Duke University,,2.0,,Lack of Funding,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,OTHER,,,,,,,2023,0.0
NCT03077412,,2017-03-08,2022-02-16,2021-10-29,2022-04-07,2017-03-08,2017-03-13,ACTUAL,2022-04-07,2022-04-08,ACTUAL,2022-04-07,2022-04-08,ACTUAL,2022-04-07,2022-04-08,ACTUAL,2017-04-06,ACTUAL,2017-04-06,2022-04,2022-04-30,2021-02-17,ACTUAL,2021-02-17,2021-01-20,ACTUAL,2021-01-20,,INTERVENTIONAL,Divergence2,,Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease,"A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease",COMPLETED,,PHASE2,57.0,ACTUAL,Gilead Sciences,,3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,,,,,,2021,1.0
NCT03682770,,2018-09-21,2023-10-13,2021-10-14,2024-01-12,2018-09-21,2018-09-25,ACTUAL,2024-01-12,2024-02-07,ACTUAL,,2024-02-07,ACTUAL,2024-01-12,2024-02-07,ACTUAL,2018-10-03,ACTUAL,2018-10-03,2024-01,2024-01-31,2021-07-23,ACTUAL,2021-07-23,2020-10-16,ACTUAL,2020-10-16,,INTERVENTIONAL,,Full analysis set (FAS) included all randomized participants,Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy),"A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study in Pediatric Subjects With Peanut Allergy to Evaluate the Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)",COMPLETED,,PHASE2,148.0,ACTUAL,Regeneron Pharmaceuticals,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,,,,,,2021,1.0
NCT05021978,,2021-08-20,2023-10-04,,2024-02-05,2021-08-20,2021-08-26,ACTUAL,2024-02-05,2024-03-01,ACTUAL,,,,2024-02-05,2024-03-01,ACTUAL,2020-03-03,ACTUAL,2020-03-03,2024-01,2024-01-31,2022-03-24,ACTUAL,2022-03-24,2022-03-24,ACTUAL,2022-03-24,,INTERVENTIONAL,,,A Clinical Trial of PRAX-944 in Participants With Essential Tremor,"A Phase 2 Clinical Trial Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Adults With Essential Tremor",COMPLETED,,PHASE2,24.0,ACTUAL,Praxis Precision Medicines,"Due to repeated mistakes during the eligibility review process, a Corrective and Preventative Actions (CAPA) report was issued and enrollment at one site was suspended.",3.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,,,,,,2022,1.0
NCT02435992,,2015-04-24,2021-06-25,2020-07-07,2021-08-06,2015-05-01,2015-05-06,ESTIMATED,2021-08-06,2021-09-01,ACTUAL,2020-07-07,2020-07-09,ACTUAL,2021-08-06,2021-09-01,ACTUAL,2015-06-17,ACTUAL,2015-06-17,2021-08,2021-08-31,2020-06-17,ACTUAL,2020-06-17,2020-03-27,ACTUAL,2020-03-27,,INTERVENTIONAL,,,Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis,"A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis",COMPLETED,,PHASE3,1012.0,ACTUAL,Celgene,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,,,,,,2020,1.0
NCT04045028,,2019-07-22,,,2023-04-06,2019-08-02,2019-08-05,ACTUAL,,,,,,,2023-04-06,2023-04-07,ACTUAL,2019-07-22,ACTUAL,2019-07-22,2023-04,2023-04-30,2023-03-28,ACTUAL,2023-03-28,2023-03-28,ACTUAL,2023-03-28,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Activity of Tiragolumab in Participants With Relapsed or Refractory Multiple Myeloma or With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma","A Phase Ia/Ib Open-Label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma, and as a Single Agent and in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma",TERMINATED,,PHASE1,41.0,ACTUAL,"Genentech, Inc.",,5.0,,Slow recruitment,f,,,,,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,,,,,,2023,0.0
NCT05201313,,2022-01-04,,,2023-09-16,2022-01-15,2022-01-21,ACTUAL,,,,,,,2023-09-16,2023-09-21,ACTUAL,2022-01-20,ACTUAL,2022-01-20,2023-09,2023-09-30,2022-08-08,ACTUAL,2022-08-08,2022-07-08,ACTUAL,2022-07-08,,INTERVENTIONAL,LISPRAY,,Efficacy and Safety of the Application of Local Anaesthetic in Spray to Repair of 1st- 2nd Perineal Lacerations,Randomised Controlled Trial to Evaluate the Efficacy of Local Anaesthetic Application in Spray for the Repair of 1st- 2nd Perineal Lacerations Following Vaginal Delivery,COMPLETED,,PHASE3,136.0,ACTUAL,Azienda Sanitaria-Universitaria Integrata di Udine,,2.0,,,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,OTHER,,,,,,,2022,1.0
NCT04134208,,2019-10-18,,,2022-07-18,2019-10-18,2019-10-22,ACTUAL,,,,,,,2022-07-18,2022-07-20,ACTUAL,2019-09-19,ACTUAL,2019-09-19,2022-07,2022-07-31,2022-06-28,ACTUAL,2022-06-28,2022-06-28,ACTUAL,2022-06-28,,INTERVENTIONAL,,,An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer,18F-Fluciclovine PET CT as an Indicator of Therapeutic Response in Metastatic Prostate Carcinoma (M1PCa),TERMINATED,,PHASE4,2.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,Slow accrual,f,,,,t,t,f,,,,,,,,,,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,OTHER,,,,,,,2022,0.0
NCT02904954,,2016-05-18,2021-07-12,,2023-10-06,2016-09-13,2016-09-19,ESTIMATED,2021-07-12,2021-08-03,ACTUAL,,,,2023-10-06,2023-10-11,ACTUAL,2016-12-02,ACTUAL,2016-12-02,2023-01,2023-01-31,2022-10-04,ACTUAL,2022-10-04,2020-09-16,ACTUAL,2020-09-16,,INTERVENTIONAL,,,"Durvalumab (MEDI4736) With or Without SBRT in Clinical Stage I, II and IIIA Non-small Cell Lung Cancer","A Randomized Phase 2 Trial of Durvalumab (MEDI4736) With or Without SBRT in Clinical Stage I, II, and IIIA Non-small Cell Lung Cancer (NSCLC)",COMPLETED,,PHASE2,60.0,ACTUAL,Weill Medical College of Cornell University,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,OTHER,,,,,,,2022,1.0
NCT05264922,,2021-12-27,,,2023-02-14,2022-02-22,2022-03-03,ACTUAL,,,,,,,2023-02-14,2023-02-15,ACTUAL,2022-01-09,ACTUAL,2022-01-09,2023-02,2023-02-28,2022-07-22,ACTUAL,2022-07-22,2022-07-22,ACTUAL,2022-07-22,,INTERVENTIONAL,SVF,,Stromal Vascular Fraction (SVF) Cells for Non-Operative Treatment of Small Rotator Cuff Tears,Stromal Vascular Fraction (SVF) Cells for Non-Operative Treatment of Small Rotator Cuff Tears,WITHDRAWN,,PHASE2,0.0,ACTUAL,AdventHealth,,2.0,,Study never started. PI left institution.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,OTHER,,,,,,,2022,0.0
NCT05330286,,2022-04-08,,,2023-07-13,2022-04-08,2022-04-15,ACTUAL,,,,,,,2023-07-13,2023-07-14,ACTUAL,2022-04-13,ACTUAL,2022-04-13,2023-07,2023-07-31,2022-08-19,ACTUAL,2022-08-19,2022-08-19,ACTUAL,2022-08-19,,INTERVENTIONAL,,,"Study to Compare the Pharmacokinetics, Safety and Tolerability of the Pediatric and Adult Branaplam Formulation in Healthy Adults and the Effect of Food on the Latter.","Randomized, Single-dose, Open-label, Two-part, Two-period, Cross-over Study to Compare the Pharmacokinetics, Safety and Tolerability of the Pediatric With an Adult Formulation of Branaplam and to Investigate the Adult Formulation in Fed and Fasted State in Healthy Participants",TERMINATED,,PHASE1,9.0,ACTUAL,Novartis,,4.0,,The compound is no longer suitable for further clinical development due to a safety finding in a later phase program.,f,,,,f,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.",2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,,,,,,2022,0.0
NCT04523207,,2020-08-20,,,2023-12-07,2020-08-20,2020-08-21,ACTUAL,,,,,,,2023-12-07,2023-12-11,ACTUAL,2020-08-19,ACTUAL,2020-08-19,2023-12,2023-12-31,2023-10-25,ACTUAL,2023-10-25,2023-10-23,ACTUAL,2023-10-23,,INTERVENTIONAL,,,A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases,"A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases",COMPLETED,,PHASE2,108.0,ACTUAL,"Janssen Research & Development, LLC",,1.0,,,f,,,,f,t,f,,,,,,,,https://www.janssen.com/clinical-trials/transparency,YES,"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu",2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,INDUSTRY,,,,,,,2023,1.0
NCT02704325,,2015-12-23,,,2018-02-02,2016-03-04,2016-03-10,ESTIMATED,,,,,,,2018-02-02,2018-02-06,ACTUAL,2016-04,ESTIMATED,2016-04-30,2018-02,2018-02-28,2020-02,ESTIMATED,2020-02-29,2018-07,ESTIMATED,2018-07-31,,INTERVENTIONAL,,,Gene Transfer Clinical Trial for Duchenne Muscular Dystrophy Using rAAVrh74.MCK.GALGT2,Phase I Gene Transfer Clinical Trial for Duchenne Muscular Dystrophy Using rAAVrh74.MCK.GALGT2,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Nationwide Children's Hospital,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,OTHER,,,,,,,2020,0.0
NCT04393454,,2020-05-13,2024-06-28,,2024-06-28,2020-05-16,2020-05-19,ACTUAL,2024-06-28,2024-07-25,ACTUAL,,,,2024-06-28,2024-07-25,ACTUAL,2020-11-16,ACTUAL,2020-11-16,2024-06,2024-06-30,2023-05-16,ACTUAL,2023-05-16,2023-05-16,ACTUAL,2023-05-16,,INTERVENTIONAL,,6 baseline participants,"Study to Evaluate the Efficacy and Safety of Sirolimus in Subjects With Metastatic, Mismatch Repair Deficient Solid Tumors After Immunotherapy","Phase II Study to Evaluate the Efficacy and Safety of Sirolimus in Subjects With Metastatic, Mismatch Repair Deficient Solid Tumors After Immunotherapy",TERMINATED,,PHASE2,6.0,ACTUAL,Albert Einstein College of Medicine,,1.0,,Following discussion with the Cancer Center the PI elected to terminate the study.,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,OTHER,,,,,,,2023,0.0
NCT02951377,,2016-10-27,,,2022-04-01,2016-10-31,2016-11-01,ESTIMATED,,,,,,,2022-04-01,2022-04-11,ACTUAL,2017-10-01,ACTUAL,2017-10-01,2020-03,2020-03-31,2020-01-31,ACTUAL,2020-01-31,2020-01-31,ACTUAL,2020-01-31,,INTERVENTIONAL,,,Mechanical Diagnosis and Treatment and/or Steroid Injections for Lumbar Radiculopathy,Mechanical Diagnosis and Treatment and/or Transforaminal Epidural Steroid Injections Versus Usual Care for Chronic Lumbar Radiculopathy: A Pilot Study.,TERMINATED,,PHASE1,27.0,ACTUAL,University of Alberta,,2.0,,Recruitment,f,,,,f,f,f,,,,,,,,,,,2024-10-15 05:27:23.786062,2024-10-15 05:27:23.786062,OTHER,,,,,,,2020,0.0
NCT03585764,,2018-07-02,,,2024-04-10,2018-07-02,2018-07-13,ACTUAL,,,,,,,2024-04-10,2024-04-12,ACTUAL,2018-10-24,ACTUAL,2018-10-24,2024-04,2024-04-30,2024-03-26,ACTUAL,2024-03-26,2024-03-26,ACTUAL,2024-03-26,,INTERVENTIONAL,,,"MOv19-BBz CAR T Cells in aFR Expressing Recurrent High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","Phase I Clinical Trial of Adoptive Transfer of Autologous Folate Receptor - Alpha Redirected T Cells for Recurrent High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer",TERMINATED,,PHASE1,46.0,ACTUAL,University of Pennsylvania,,4.0,,This study was halted prematurely due to recruitment barriers,f,,,,t,t,t,t,,,,,,,,NO,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,OTHER,,,,,,,2024,0.0
NCT05156034,,2021-11-16,,,2023-03-09,2021-12-13,2021-12-14,ACTUAL,,,,,,,2023-03-09,2023-03-13,ACTUAL,2021-12-21,ACTUAL,2021-12-21,2023-03,2023-03-31,2022-09-05,ACTUAL,2022-09-05,2022-09-05,ACTUAL,2022-09-05,,INTERVENTIONAL,,,"A Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SRK-001 in Healthy Participants","A Randomized, Placebo-Controlled, Double-blind, Multiple Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of SRK-001 in Healthy Participants",TERMINATED,,PHASE1,16.0,ACTUAL,Sarkana Pharma Inc,,4.0,,Due to occurrence of eye related adverse events.,f,,,,f,t,f,,,,,,,,,,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,OTHER,,,,,,,2022,0.0
NCT04591808,,2020-09-30,,,2023-10-17,2020-10-12,2020-10-19,ACTUAL,,,,,,,2023-10-17,2023-10-18,ACTUAL,2021-09-09,ACTUAL,2021-09-09,2023-10,2023-10-31,2022-04-08,ACTUAL,2022-04-08,2022-04-08,ACTUAL,2022-04-08,,INTERVENTIONAL,,,Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia,"Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia, 8 Weeks, Phase 3, Randomized, Double-blind, Active-control, Multinational, Multi-center, Parallel Study",TERMINATED,,PHASE3,146.0,ACTUAL,Servier,,3.0,,for strategic reasons,f,,,,f,f,f,,,,,,After Marketing Authorisation in EEA or US if the study is used for the approval.,Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.,https://clinicaltrials.servier.com/,YES,"Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.",2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,INDUSTRY,,,,,,,2022,0.0
NCT02958917,,2016-10-31,2022-09-27,,2022-12-14,2016-11-04,2016-11-08,ESTIMATED,2022-12-14,2023-01-09,ACTUAL,,,,2022-12-14,2023-01-09,ACTUAL,2017-06-05,ACTUAL,2017-06-05,2022-12,2022-12-31,2021-03-02,ACTUAL,2021-03-02,2021-03-02,ACTUAL,2021-03-02,,INTERVENTIONAL,,,Study of Efficacy and Safety of Pirfenidone in Patients With Fibrotic Hypersensitivity Pneumonitis,"A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy and Safety of Pirfenidone in Patients With Fibrotic Hypersensitivity Pneumonitis",TERMINATED,,PHASE2,40.0,ACTUAL,National Jewish Health,,2.0,,covid-19 pandemic,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,OTHER,,,,,,,2021,0.0
NCT03422094,,2018-01-29,,,2021-10-26,2018-01-29,2018-02-05,ACTUAL,,,,,,,2021-10-26,2021-10-27,ACTUAL,2018-10-31,ACTUAL,2018-10-31,2021-10,2021-10-31,2020-12-31,ACTUAL,2020-12-31,2020-04-26,ACTUAL,2020-04-26,,INTERVENTIONAL,,,"Neoantigen-based Personalized Vaccine Combined With Immune Checkpoint Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma","A Pilot Study to Assess the Safety, Feasibility, and Immunogenicity of a Neoantigen-based Personalized Vaccine Combined With Immune Checkpoint Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma",TERMINATED,,PHASE1,3.0,ACTUAL,Washington University School of Medicine,,5.0,,Manufacturer changed focus to cell therapy,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,OTHER,,,,,,,2020,0.0
NCT02083354,,2014-02-13,2021-02-15,2018-10-10,2022-01-04,2014-03-06,2014-03-11,ESTIMATED,2021-03-16,2021-03-17,ACTUAL,2019-02-11,2019-02-15,ACTUAL,2022-01-04,2022-02-01,ACTUAL,2014-03-18,ACTUAL,2014-03-18,2022-01,2022-01-31,2021-04-19,ACTUAL,2021-04-19,2018-02-23,ACTUAL,2018-02-23,,INTERVENTIONAL,,,Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 Mutation-Positive Melanoma,"An Open-Label, Multi-Center Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 Mutation-Positive Melanoma",COMPLETED,,PHASE2,77.0,ACTUAL,Novartis,,1.0,,,f,,,,f,t,f,,,,,,,,,UNDECIDED,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,INDUSTRY,,,,,,,2021,1.0
NCT03863080,,2019-02-20,2023-10-05,2021-10-06,2023-11-30,2019-03-04,2019-03-05,ACTUAL,2023-11-30,2023-12-20,ACTUAL,,2023-12-20,ACTUAL,2023-11-30,2023-12-20,ACTUAL,2019-05-21,ACTUAL,2019-05-21,2023-11,2023-11-30,2020-12-21,ACTUAL,2020-12-21,2020-10-07,ACTUAL,2020-10-07,,INTERVENTIONAL,,Safety Analysis Set (SAF) comprised of all participants who received at least 1 dose of study medication.,A Study of RVT-1401 in Myasthenia Gravis (MG) Patients,"A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension of RVT-1401 in Myasthenia Gravis Patients",COMPLETED,,PHASE2,17.0,ACTUAL,Immunovant Sciences GmbH,,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,INDUSTRY,,,,,,,2020,1.0
NCT04171843,,2019-11-12,,,2023-09-18,2019-11-18,2019-11-21,ACTUAL,,,,,,,2023-09-18,2023-09-21,ACTUAL,2020-04-30,ACTUAL,2020-04-30,2023-09,2023-09-30,2022-10-19,ACTUAL,2022-10-19,2022-10-19,ACTUAL,2022-10-19,,INTERVENTIONAL,,,"A Dose-escalation Study to Evaluate the Safety and Clinical Activity of PBCAR269A, With or Without Nirogacestat, in Study Participants With Relapsed/Refractory Multiple Myeloma","A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion Study to Evaluate the Safety and Clinical Activity of PBCAR269A, With or Without Nirogacestat, in Study Participants With Relapsed/Refractory Multiple Myeloma",TERMINATED,,PHASE1,48.0,ACTUAL,"Precision BioSciences, Inc.",,6.0,,Study was terminated due to lack of sufficient therapeutic effect,f,,,,,t,f,,,,,,,,,,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,INDUSTRY,,,,,,,2022,0.0
NCT02976038,,2016-11-18,2021-02-08,,2021-11-19,2016-11-23,2016-11-29,ESTIMATED,2021-11-19,2021-12-17,ACTUAL,,,,2021-11-19,2021-12-17,ACTUAL,2016-12,ACTUAL,2016-12-31,2021-11,2021-11-30,2020-04-09,ACTUAL,2020-04-09,2020-03-09,ACTUAL,2020-03-09,,INTERVENTIONAL,,All participants for whom Baseline measurements were taken.,Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM),"A Multicenter, Open-Label Phase 2 Extension Trial to Characterize the Long-term Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)",TERMINATED,,PHASE2,28.0,ACTUAL,Stealth BioTherapeutics Inc.,,1.0,,Registration trial did not meet the primary end points,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,INDUSTRY,,,,,,,2020,0.0
NCT03029871,,2017-01-19,,,2019-08-09,2017-01-20,2017-01-24,ESTIMATED,,,,,,,2019-08-09,2019-08-13,ACTUAL,2017-01-13,ACTUAL,2017-01-13,2019-08,2019-08-31,2022-12-31,ESTIMATED,2022-12-31,2018-12-31,ESTIMATED,2018-12-31,,INTERVENTIONAL,NSCLC,,Oncolytic Adenovirus-Mediated Gene Therapy for Lung Cancer,Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic Gene Therapy in Combination With Stereotactic Body Radiation Therapy (SBRT) in Clinical Stage 1/11A (T1A-T2B) Non-Small Cell Lung Cancer,WITHDRAWN,,PHASE1,0.0,ACTUAL,Henry Ford Health System,,1.0,,No participants were enrolled,f,,,,t,,,,,,,,,,,NO,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,OTHER,,,,,,,2022,0.0
NCT04502082,,2020-07-22,,,2024-04-03,2020-08-03,2020-08-06,ACTUAL,,,,,,,2024-04-03,2024-04-05,ACTUAL,2021-04-14,ACTUAL,2021-04-14,2024-04,2024-04-30,2023-06-20,ACTUAL,2023-06-20,2023-06-20,ACTUAL,2023-06-20,,INTERVENTIONAL,,,Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1),"An Open-Label, Dose Escalation, Multi-Center Phase I/II Research Trial to Assess the Safety of ET140203 T Cells and Determine the Recommended Phase II Dose (RP2D) in Adults With Advanced Hepatocellular Carcinoma (HCC) (ARYA-1)",TERMINATED,,PHASE1/PHASE2,6.0,ACTUAL,Eureka Therapeutics Inc.,,1.0,,Directing efforts to the pediatric study (ARYA-2) for this product,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,INDUSTRY,,,,,,,2023,0.0
NCT05177796,,2021-12-14,,,2023-07-26,2021-12-14,2022-01-05,ACTUAL,,,,,,,2023-07-26,2023-07-28,ACTUAL,2022-03-11,ACTUAL,2022-03-11,2023-07,2023-07-31,2023-07-26,ESTIMATED,2023-07-26,2023-07-26,ESTIMATED,2023-07-26,,INTERVENTIONAL,,,Panitumumab and Pembrolizumab in Combination With Neoadjuvant Chemotherapy for the Treatment of Stage III-IV Triple Negative Breast Cancer,Enhancing Immunotherapy by Targeting the EGFR Pathway in Inflammatory Breast Cancer: A Phase II Study of Panitumumab (PmAb) and Pembrolizumab (Pembro) in Combination With Neoadjuvant Chemotherapy (NAC) in Patients With Newly Diagnosed Triple Negative Inflammatory Breast Cancer (TN-IBC),WITHDRAWN,,PHASE2,0.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,0 participants recruited,f,,,,t,t,f,,,,,,,,,,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,OTHER,,,,,,,2023,0.0
NCT01774721,,2013-01-21,2018-03-29,,2023-02-06,2013-01-21,2013-01-24,ESTIMATED,2018-03-29,2018-10-26,ACTUAL,,,,2023-02-06,2023-11-14,ACTUAL,2013-05-09,ACTUAL,2013-05-09,2023-01,2023-01-31,2022-01-27,ACTUAL,2022-01-27,2016-07-29,ACTUAL,2016-07-29,,INTERVENTIONAL,,"ITT Population included all participants who were randomized, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or received a different treatment from that to which they were randomized.",ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.,"ARCHER 1050: A RANDOMIZED, OPEN-LABEL, PHASE 3, EFFICACY AND SAFETY STUDY OF DACOMITINIB (PF-00299804) VERSUS GEFITINIB FOR THE FIRST LINE TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER IN SUBJECTS WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) ACTIVATING MUTATION(S)",COMPLETED,,PHASE3,452.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,,,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,INDUSTRY,,,,,,,2022,1.0
NCT05024032,,2021-08-25,2023-12-26,,2023-12-26,2021-08-25,2021-08-27,ACTUAL,2023-12-26,2024-01-19,ACTUAL,,,,2023-12-26,2024-01-19,ACTUAL,2021-09-01,ACTUAL,2021-09-01,2023-12,2023-12-31,2022-12-27,ACTUAL,2022-12-27,2022-12-27,ACTUAL,2022-12-27,,INTERVENTIONAL,SURMOUNT-CN,All participants who received at least one dose of study drug.,A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN),"Efficacy and Safety of Tirzepatide Once Weekly in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-CN)",COMPLETED,,PHASE3,210.0,ACTUAL,Eli Lilly and Company,,3.0,,,f,,,,f,t,f,,,t,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,INDUSTRY,,,,,,,2022,1.0
NCT04348916,,2020-04-13,,,2023-06-06,2020-04-13,2020-04-16,ACTUAL,,,,,,,2023-06-06,2023-06-08,ACTUAL,2020-05-20,ACTUAL,2020-05-20,2023-06,2023-06-30,2023-05-31,ACTUAL,2023-05-31,2023-05-31,ACTUAL,2023-05-31,,INTERVENTIONAL,,,"Study of ONCR-177 Alone and in Combination With PD-1 Blockade in Adult Subjects With Advanced and/or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumors or With Liver Metastases of Solid Tumors","A Phase 1, Open-Label, Multicenter, Dose Escalation and Expansion Study of ONCR-177, an Oncolytic Herpes Simplex Virus for Intratumoral Injection, Alone and in Combination With PD-1 Blockade in Adult Subjects With Advanced and/or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumors or With Liver Metastases of Solid Tumors",TERMINATED,,PHASE1,66.0,ACTUAL,"Oncorus, Inc.",,6.0,,Terminated due to Oncorus portfolio reprioritization,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,INDUSTRY,,,,,,,2023,0.0
NCT02507232,,2015-07-21,,,2020-07-27,2015-07-21,2015-07-23,ESTIMATED,,,,,,,2020-07-27,2020-07-28,ACTUAL,2017-04-17,ACTUAL,2017-04-17,2020-07,2020-07-31,2020-07-27,ACTUAL,2020-07-27,2020-07-27,ACTUAL,2020-07-27,,INTERVENTIONAL,,,Study of NovoTTF-200A Alone and With Temozolomide in Patients With Low-Grade Gliomas,"A Multicenter, Open-Label, Randomized Study of NovoTTF-200A Alone and Combined With Temozolomide in Patients With Low-Grade Gliomas",TERMINATED,,EARLY_PHASE1,2.0,ACTUAL,Saint John's Cancer Institute,,2.0,,low enrollment,f,,,,f,f,t,,,,,,,,,UNDECIDED,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,OTHER,,,,,,,2020,0.0
NCT03418714,,2018-01-26,2021-01-22,,2021-02-11,2018-01-26,2018-02-01,ACTUAL,2021-02-11,2021-03-04,ACTUAL,,,,2021-02-11,2021-03-04,ACTUAL,2017-12-14,ACTUAL,2017-12-14,2021-02,2021-02-28,2020-03-02,ACTUAL,2020-03-02,2020-03-02,ACTUAL,2020-03-02,,INTERVENTIONAL,,,Effects of Salvinorin A on Brain Function,Effects of Salvinorin A on Brain Function,COMPLETED,,PHASE1/PHASE2,13.0,ACTUAL,Johns Hopkins University,,1.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,OTHER,,,,,,,2020,1.0
NCT04960202,,2021-07-10,2022-11-22,,2023-01-13,2021-07-10,2021-07-13,ACTUAL,2023-01-13,2023-02-09,ACTUAL,,,,2023-01-13,2023-02-09,ACTUAL,2021-07-16,ACTUAL,2021-07-16,2023-01,2023-01-31,2022-04-25,ACTUAL,2022-04-25,2021-12-09,ACTUAL,2021-12-09,,INTERVENTIONAL,,"Full analysis set included all participants randomly assigned to study intervention, whether or not administered the study intervention.",EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19,"AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT INCREASED RISK OF PROGRESSING TO SEVERE ILLNESS",COMPLETED,,PHASE2/PHASE3,2246.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,INDUSTRY,,,,,,,2022,1.0
NCT03181932,,2017-06-01,2021-09-02,,2022-12-14,2017-06-07,2017-06-09,ACTUAL,2021-10-10,2021-11-05,ACTUAL,,,,2022-12-14,2022-12-16,ACTUAL,2017-09-20,ACTUAL,2017-09-20,2022-12,2022-12-31,2021-01-15,ACTUAL,2021-01-15,2020-07-28,ACTUAL,2020-07-28,,INTERVENTIONAL,,The number of baseline participants include both age groups (participants 6-21 years and \>21 years).,AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis,"A Phase III, Randomized, Double-blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis Patients",COMPLETED,,PHASE3,188.0,ACTUAL,Savara Inc.,"A total of 200 participants were to be randomized. Consequent to the outbreak of COVID-19, the recruitment was stopped prematurely when 188 participants had been randomized.~The CFQ-R and CFRSD-CRISS were administered every two weeks using a hand-held e-Diary. The e-Diary had not been activated at the baseline visit for 39 participants. For these participants, missing baseline measurements were imputed with the population median baseline value for inferential analyses.",3.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,INDUSTRY,,,,,,,2021,1.0
NCT02658396,,2016-01-13,,,2017-06-30,2016-01-14,2016-01-18,ESTIMATED,,,,,,,2017-06-30,2017-07-05,ACTUAL,,,,2017-06,2017-06-30,2022-01,ESTIMATED,2022-01-31,2019-05,ESTIMATED,2019-05-31,,INTERVENTIONAL,,,GO-203-2C + Bortezomib For Relapsed Or Refractory MM,"A Phase I Trial of the MUC1 Inhibitor, GO-203-2c, in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma",WITHDRAWN,,PHASE1,0.0,ACTUAL,Dana-Farber Cancer Institute,,1.0,,Study was never open due to lack of funding,f,,,,t,,,,,,,,,,,,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,OTHER,,,,,,,2022,0.0
NCT02917096,,2016-09-26,,,2023-12-05,2016-09-26,2016-09-28,ESTIMATED,,,,,,,2023-12-05,2023-12-12,ACTUAL,2016-11-13,ACTUAL,2016-11-13,2023-12,2023-12-31,2023-08-31,ACTUAL,2023-08-31,2020-04-16,ACTUAL,2020-04-16,,INTERVENTIONAL,,,Ruxolitinib Phosphate and Chemotherapy Given Before and After Reduced Intensity Donor Stem Cell Transplant in Treating Patients With Myelofibrosis,Pilot Open-Label Study of Safety and Efficacy of Ruxolitinib Given Peri-Transplant During Reduced Intensity Allogeneic Hematopoietic Cell Transplantation (HCT) in Patients With Myelofibrosis,COMPLETED,,PHASE1,18.0,ACTUAL,City of Hope Medical Center,,1.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,OTHER,,,,,,,2023,1.0
NCT02864784,,2016-08-02,,,2024-02-25,2016-08-09,2016-08-12,ESTIMATED,,,,,,,2024-02-25,2024-02-28,ACTUAL,2022-06,ESTIMATED,2022-06-30,2024-02,2024-02-29,2023-12,ESTIMATED,2023-12-31,2023-12,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,"Investigating the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) on the Treatment of Subjects With CRPC","A Prospective, Multicenter, Randomized, Placebo-Controlled, Two-armed, Double-blind Pilot Study to Evaluate the Safety, Tolerability and Efficacy of ACC vs. Placebo for the Treatment of Subjects With Castrate Resistant Prostate Cancer With Bone Metastasis",WITHDRAWN,,PHASE1,0.0,ACTUAL,Amorphical Ltd.,,2.0,,Budget,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 05:33:24.47274,2024-10-15 05:33:24.47274,INDUSTRY,,,,,,,2023,0.0
NCT03847896,,2019-02-14,2022-07-19,,2023-04-11,2019-02-19,2019-02-20,ACTUAL,2022-09-02,2022-09-30,ACTUAL,,,,2023-04-11,2023-04-13,ACTUAL,2019-03-20,ACTUAL,2019-03-20,2023-04,2023-04-30,2021-07-20,ACTUAL,2021-07-20,2021-07-20,ACTUAL,2021-07-20,,INTERVENTIONAL,DENALI,"Of the 1,001 participants randomized, the full analysis set across all ages comprises 1,000 participants as one participant was randomized in error and did not receive study treatment. This participant has therefore been excluded from the summaries of baseline characteristics and efficacy.",A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered Dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma,"A 12-week, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT008 and PT007 Administered QID in Adults and Children 4 Years of Age or Older With Asthma",COMPLETED,,PHASE3,1001.0,ACTUAL,Bond Avillion 2 Development LP,,5.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,INDUSTRY,,,,,,,2021,1.0
NCT03763877,,2018-11-28,2021-08-11,,2021-10-01,2018-12-03,2018-12-04,ACTUAL,2021-10-01,2021-10-28,ACTUAL,,,,2021-10-01,2021-10-28,ACTUAL,2019-03-29,ACTUAL,2019-03-29,2021-10,2021-10-31,2020-08-10,ACTUAL,2020-08-10,2020-08-03,ACTUAL,2020-08-03,,INTERVENTIONAL,,"Intent to treat set (ITTS), defined as all as-randomized patients who received at least one dose of study treatment.",A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD,"A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD",COMPLETED,,PHASE2,121.0,ACTUAL,Poxel SA,,4.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,INDUSTRY,,,,,,,2020,1.0
NCT02640534,,2015-12-22,,,2023-06-26,2015-12-28,2015-12-29,ESTIMATED,,,,,,,2023-06-26,2023-06-27,ACTUAL,2016-06-10,ACTUAL,2016-06-10,2023-06,2023-06-30,2023-03-16,ACTUAL,2023-03-16,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,,,Investigation of Metformin in Patients With Castration Resistant Prostate Cancer in Combination With Enzalutamide vs. Enzalutamide Alone,"Investigation of Metformin in Patients With Castration Resistant Prostate Cancer in Combination With Enzalutamide vs. Enzalutamide Alone (IMPROVE TRIAL): A Randomized, Open Label, Phase II Trial",TERMINATED,,PHASE2,169.0,ACTUAL,Swiss Group for Clinical Cancer Research,,2.0,,"The decision is based on the fact that with the current follow up of around 10 years, the relevant secondary endpoints can adequately be addressed according to protocol. The addition of follow up data will not significantly impact these results.",f,,,,f,,,,,,,,,,,NO,,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,OTHER,,,,,,,2023,0.0
NCT04342325,,2020-04-08,,,2023-04-27,2020-04-10,2020-04-13,ACTUAL,,,,,,,2023-04-27,2023-05-01,ACTUAL,2020-06-15,ACTUAL,2020-06-15,2023-04,2023-04-30,2023-03-31,ACTUAL,2023-03-31,2022-11-01,ACTUAL,2022-11-01,,INTERVENTIONAL,,,The Clinical Trial of ADR-001 for IgA Nephropathy,"Open-label, Multiple-center, Dose-Escalation Study to Evaluate the Safety and Tolerability of ADR-001 for the Treatment for Immunoglobulin A (IgA) Nephropathy",COMPLETED,,PHASE1,9.0,ACTUAL,Nagoya University,,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,OTHER,,,,,,,2023,1.0
NCT03486834,,2018-03-28,2021-10-01,,2024-01-19,2018-03-28,2018-04-03,ACTUAL,2021-10-13,2021-11-10,ACTUAL,,,,2024-01-19,2024-01-23,ACTUAL,2018-04-30,ACTUAL,2018-04-30,2024-01,2024-01-31,2021-06-30,ACTUAL,2021-06-30,2020-10-30,ACTUAL,2020-10-30,,INTERVENTIONAL,,,V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002),"Double-Blind, Randomized, Placebo-Controlled Phase 2b, Multi-center Study to Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of a 2-Dose and a 3-Dose Regimen of V160 (Cytomegalovirus [CMV] Vaccine) in Healthy Seronegative Women, 16 to 35 Years of Age",COMPLETED,,PHASE2,2200.0,ACTUAL,Merck Sharp & Dohme LLC,,3.0,,,f,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,INDUSTRY,,,,,,,2021,1.0
NCT05486377,,2022-08-01,,,2023-08-07,2022-08-02,2022-08-03,ACTUAL,,,,,,,2023-08-07,2023-08-09,ACTUAL,2022-08-02,ACTUAL,2022-08-02,2023-08,2023-08-31,2023-05-19,ACTUAL,2023-05-19,2023-05-19,ACTUAL,2023-05-19,,INTERVENTIONAL,,,Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia,Efficacy and Safety of Remimazolam vs. Inhalational Anesthetics for General Anesthesia for the Ablation of Arrhythmia: Randomized Controlled Trial,COMPLETED,,PHASE4,96.0,ACTUAL,Seoul National University Bundang Hospital,,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,OTHER,,,,,,,2023,1.0
NCT04410042,,2020-05-08,,,2024-03-13,2020-05-27,2020-06-01,ACTUAL,,,,,,,2024-03-13,2024-03-15,ACTUAL,2021-01-29,ACTUAL,2021-01-29,2024-03,2024-03-31,2024-01-16,ACTUAL,2024-01-16,2024-01-16,ACTUAL,2024-01-16,,INTERVENTIONAL,,,Tranexamic Acid Use to Reduce Blood Transfusion in Pediatric Cancer Patients Undergoing Limb Salvage Procedure,Tranexamic Acid (TXA) to Reduce Volume Of Blood Transfused In Pediatric And Young Adult Cancer Patients Undergoing Limb Salvage Procedure Of A Lower Extremity,TERMINATED,,PHASE3,15.0,ACTUAL,St. Jude Children's Research Hospital,,2.0,,Per sponsor,,,,,t,t,f,,,,,,Data will be made available at the time of article publication.,"Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.",,YES,"Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.",2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,OTHER,,,,,,,2024,0.0
NCT03294252,,2017-09-22,,,2022-04-19,2017-09-26,2017-09-27,ACTUAL,,,,,,,2022-04-19,2022-04-25,ACTUAL,2017-05-24,ACTUAL,2017-05-24,2022-04,2022-04-30,2021-10-01,ACTUAL,2021-10-01,2019-02-05,ACTUAL,2019-02-05,,INTERVENTIONAL,PIPOX,,Oxaliplatin in PIPAC for Nonresectable Peritoneal Metastases of Digestive Cancers,"Phase I / II Dose Escalation of Oxaliplatin Via a Laparoscopic Approach of Aerosol Pressurized Intraperitoneal Chemotherapy for Nonresectable Peritoneal Metastases of Digestive Cancers (Stomach, Hail and Colorectal)",TERMINATED,,PHASE1/PHASE2,34.0,ACTUAL,Institut Cancerologie de l'Ouest,,1.0,,The 34 patients included had all completed their treatment period under the protocol and the data could be collected to assess the main objective and the secondary objectives before the last theoretical follow-up.,f,,,,f,f,f,,,,,,,,,,,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,OTHER,,,,,,,2021,0.0
NCT02929394,,2016-10-07,,,2020-09-01,2016-10-07,2016-10-11,ESTIMATED,,,,,,,2020-09-01,2020-09-02,ACTUAL,2017-11-07,ACTUAL,2017-11-07,2019-11,2019-11-30,2020-06-05,ACTUAL,2020-06-05,2020-06-05,ACTUAL,2020-06-05,,INTERVENTIONAL,,,Trabectedin Maintenance Post 1st-line in STS,Maintenance Therapy With Trabectedin Versus Observation After First Line Treatment With Doxorubicin of Patients With Advanced or Metastatic Soft Tissue Sarcoma.,TERMINATED,,PHASE3,13.0,ACTUAL,European Organisation for Research and Treatment of Cancer - EORTC,,2.0,,Poor accrual,f,,,,t,f,f,,,,,,,,,YES,All publications must comply with the terms specified in the EORTC Policy 009 Release of Results and Publication Policy.,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,NETWORK,,,,,,,2020,0.0
NCT02012153,,2013-11-29,,,2023-05-30,2013-12-10,2013-12-16,ESTIMATED,,,,,,,2023-05-30,2023-06-01,ACTUAL,2013-12-04,ACTUAL,2013-12-04,2023-05,2023-05-31,2023-05-29,ACTUAL,2023-05-29,2023-05-29,ACTUAL,2023-05-29,,INTERVENTIONAL,,,Mesenchymal Stromal Cells in Kidney Transplant Recipients,Autologous Mesenchymal Stromal Cells to Induce Tolerance in Living-donor Kidney Transplant Recipients,TERMINATED,,PHASE1,3.0,ACTUAL,Mario Negri Institute for Pharmacological Research,,1.0,,Failure to enroll the number of patients required by the protocol due to the low number of living donor transplants performed at the Clinical Center,f,,,,f,,,,,,,,,,,,,2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,OTHER,,,,,,,2023,0.0
NCT03739203,,2018-11-09,2022-08-26,,2022-08-26,2018-11-09,2018-11-13,ACTUAL,2022-08-26,2022-09-21,ACTUAL,,,,2022-08-26,2022-09-21,ACTUAL,2018-11-10,ACTUAL,2018-11-10,2022-08,2022-08-31,2021-09-06,ACTUAL,2021-09-06,2021-09-06,ACTUAL,2021-09-06,,INTERVENTIONAL,,Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.,"The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone","A Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to Antidepressants Alone",COMPLETED,,PHASE3,752.0,ACTUAL,AbbVie,,3.0,,,f,,,,f,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,INDUSTRY,,,,,,,2021,1.0
NCT05165771,,2021-12-08,,,2022-05-11,2021-12-08,2021-12-21,ACTUAL,,,,,,,2022-05-11,2022-05-18,ACTUAL,2022-07,ESTIMATED,2022-07-31,2022-05,2022-05-31,2023-03,ESTIMATED,2023-03-31,2023-02,ESTIMATED,2023-02-28,,INTERVENTIONAL,,,"Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-modifying Antirheumatic Drug(s) (bDMARDs) Treatment","A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 on Background Therapy With Conventional Synthetic Disease-modifying Antirheumatic Drug(s) (csDMARDs) in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment",WITHDRAWN,,PHASE2,0.0,ACTUAL,Gilead Sciences,,4.0,,Sponsor decision to withdraw study.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,INDUSTRY,,,,,,,2023,0.0
NCT02304367,,2014-11-24,2020-07-10,2018-07-16,2024-05-02,2014-11-25,2014-12-01,ESTIMATED,2020-07-10,2020-07-30,ACTUAL,2018-07-18,2018-07-20,ACTUAL,2024-05-02,2024-05-06,ACTUAL,2015-03-24,ACTUAL,2015-03-24,2024-05,2024-05-31,2021-01-21,ACTUAL,2021-01-21,2017-07-27,ACTUAL,2017-07-27,,INTERVENTIONAL,,All enrolled participants,Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS),"A Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23, an Antibody to FGF23, in Subjects With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)-Associated Osteomalacia",COMPLETED,,PHASE2,17.0,ACTUAL,"Kyowa Kirin Co., Ltd.",,1.0,,,t,,,,f,,,,,,,,,,,,,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,INDUSTRY,,NCT03775187,AVAILABLE,,,,2021,1.0
NCT03818321,,2019-01-23,2022-10-19,,2022-10-19,2019-01-23,2019-01-28,ACTUAL,2022-10-19,2022-11-14,ACTUAL,,,,2022-10-19,2022-11-14,ACTUAL,2019-06-17,ACTUAL,2019-06-17,2022-10,2022-10-31,2021-07-01,ACTUAL,2021-07-01,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,,,Urinary Track Infection Prevention After Urogynecological Surgery,Methenamine Hippurate With Cranberry Capsules Versus Cranberry Capsules Alone for UTI Prevention in a Short-term Indwelling Foley Catheter Population After Urogynecological Surgery: A Double-Blinded Randomized Controlled Trial,COMPLETED,,PHASE2,185.0,ACTUAL,TriHealth Inc.,,2.0,,,f,,,,f,t,f,,,t,,,,,,,,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,OTHER,,,,,,,2021,1.0
NCT04244877,,2019-12-27,,,2023-06-26,2020-01-27,2020-01-28,ACTUAL,,,,,,,2023-06-26,2023-06-28,ACTUAL,2021-09-15,ACTUAL,2021-09-15,2023-06,2023-06-30,2023-12,ESTIMATED,2023-12-31,2023-05,ESTIMATED,2023-05-31,,INTERVENTIONAL,,,Rifaximin's Effect on Covert Hepatic Encephalopathy With SIBO and Gastrointestinal Dysmotility,Evaluation of the Therapeutic Effect of Rifaximin on Covert Hepatic Encephalopathy With Underlying Small Intestinal Bacterial Overgrowth and Gastrointestinal Dysmotility in Liver Cirrhosis Patients,WITHDRAWN,,PHASE3,0.0,ACTUAL,MetroHealth Medical Center,,1.0,,Study was unable to recruit participants..,,,,,t,t,f,,,f,,,,,,NO,,2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,OTHER,,,,,,,2023,0.0
NCT04355039,,2020-04-17,,,2020-08-17,2020-04-17,2020-04-21,ACTUAL,,,,,,,2020-08-17,2020-08-19,ACTUAL,2021-07-01,ESTIMATED,2021-07-01,2020-08,2020-08-31,2024-07-01,ESTIMATED,2024-07-01,2023-07-01,ESTIMATED,2023-07-01,,INTERVENTIONAL,,,INCB053914 and Pomalidomide With Dexamethasone for Relapsed and/or Refractory Multiple Myeloma,A Phase I Study of INCB053914 (Pan-PIM Kinase Inhibitor) and Pomalidomide With Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma,WITHDRAWN,,PHASE1,0.0,ACTUAL,Medical College of Wisconsin,,3.0,,Terminated for lack of funding.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,OTHER,,,,,,,2024,0.0
NCT02602210,,2015-09-22,,,2021-01-19,2015-11-09,2015-11-11,ESTIMATED,,,,,,,2021-01-19,2021-01-22,ACTUAL,2015-01,,2015-01-31,2021-01,2021-01-31,2020-12-31,ACTUAL,2020-12-31,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,SCOTCH;,,Supplemental Corticosteroids in Cirrhotic Hypotensive Patients With Suspicion of Sepsis,Supplemental Corticosteroids in Cirrhotic Hypotensive Patients With Suspicion of Sepsis,TERMINATED,,PHASE3,100.0,ACTUAL,Universitaire Ziekenhuizen KU Leuven,,2.0,,low inclusion rate,f,,,,t,,,,,,,,,,,,,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,OTHER,,,,,,,2020,0.0
NCT03345784,,2017-11-16,2023-04-03,,2024-01-25,2017-11-16,2017-11-17,ACTUAL,2023-05-11,2023-06-06,ACTUAL,,,,2024-01-25,2024-02-20,ACTUAL,2018-05-29,ACTUAL,2018-05-29,2024-01,2024-01-31,2022-05-10,ACTUAL,2022-05-10,2022-05-10,ACTUAL,2022-05-10,,INTERVENTIONAL,,,"Testing AZD1775 inC Combination With Radiotherapy and Chemotherapy in Cervical, Upper Vaginal and Uterine Cancers","A Phase I Study of the Wee 1 Kinase (Wee 1) Inhibitor AZD1775 in Combination With Radiotherapy and Cisplatin in Cervical, Upper Vaginal and Uterine Cancers (10041848, 10008224, 10008238, 10046888, 10014735)",TERMINATED,,PHASE1,10.0,ACTUAL,National Cancer Institute (NCI),The main limitation of our study is the small number of patients enrolled due to premature closure; yet the study showed the limiting toxicities of this triplet combination.,1.0,,Inadequate accrual rate,f,,,,t,t,f,,,,,,,,,,,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,NIH,,,,,,,2022,0.0
NCT03849508,,2019-02-04,,,2021-05-26,2019-02-20,2019-02-21,ACTUAL,,,,,,,2021-05-26,2021-05-27,ACTUAL,2019-02-27,ACTUAL,2019-02-27,2021-05,2021-05-31,2020-12-02,ACTUAL,2020-12-02,2020-12-02,ACTUAL,2020-12-02,,INTERVENTIONAL,PHENAD,,Phenylephrine Versus Norepinephrine for Maintenance of Hemodynamic During Cesarean Section Under Spinal Anesthesia,"Randomized, Double-blind, Controlled Clinical Trial for Comparison of Continuous Phenylephrine Versus Norepinephrine Infusion for Maintenance of Hemodynamic Stability During Cesarean Section Under Spinal Anesthesia",COMPLETED,,PHASE4,124.0,ACTUAL,Centre Hospitalier Régional d'Orléans,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,OTHER,,,,,,,2020,1.0
NCT03131219,,2017-04-24,2020-07-27,,2024-03-14,2017-04-24,2017-04-27,ACTUAL,2020-08-28,2020-09-16,ACTUAL,,,,2024-03-14,2024-03-15,ACTUAL,2017-08-31,ACTUAL,2017-08-31,2024-03,2024-03-31,2022-12-20,ACTUAL,2022-12-20,2022-12-20,ACTUAL,2022-12-20,,INTERVENTIONAL,,Safety: All participants who received at least 1 dose of study drug.,Study of Ravulizumab in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS),"A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS)",COMPLETED,,PHASE3,34.0,ACTUAL,"Alexion Pharmaceuticals, Inc.",,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,INDUSTRY,,,,,,,2022,1.0
NCT02268175,,2014-10-14,2019-09-20,,2022-03-30,2014-10-14,2014-10-20,ESTIMATED,2019-09-20,2019-10-08,ACTUAL,,,,2022-03-30,2022-04-19,ACTUAL,2014-10,,2014-10-31,2022-03,2022-03-31,2021-12,ACTUAL,2021-12-31,2018-01,ACTUAL,2018-01-31,,INTERVENTIONAL,,,Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate,A Phase II Randomized Study of Enzalutamide+Leuprolide Versus Enzalutamide+Leuprolide+Abiraterone Acetate+Prednisone as Neoadjuvant Therapy for HIgh-Risk Prostate Cancer Undergoing Prostatectomy,COMPLETED,,PHASE2,75.0,ACTUAL,Dana-Farber Cancer Institute,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,OTHER,,,,,,,2021,1.0
NCT00981058,,2009-09-18,2015-12-21,2010-09-07,2024-07-24,2009-09-21,2009-09-22,ESTIMATED,2016-05-20,2016-06-27,ESTIMATED,2010-09-07,2010-09-09,ESTIMATED,2024-07-24,2024-08-02,ACTUAL,2010-01-07,ACTUAL,2010-01-07,2024-07,2024-07-31,2024-05-30,ACTUAL,2024-05-30,2013-06-17,ACTUAL,2013-06-17,,INTERVENTIONAL,SQUIRE,,First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin,"A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)",COMPLETED,,PHASE3,1093.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 05:39:17.664019,2024-10-15 05:39:17.664019,INDUSTRY,,,,,,,2024,1.0
NCT03419559,,2018-01-14,,,2019-04-11,2018-01-26,2018-02-05,ACTUAL,,,,,,,2019-04-11,2019-04-16,ACTUAL,2018-02-28,ACTUAL,2018-02-28,2019-04,2019-04-30,2024-12,ESTIMATED,2024-12-31,2021-12,ESTIMATED,2021-12-31,,INTERVENTIONAL,,,Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combo With Durvalumab in Non-Small Cell Lung Cancer,A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC),WITHDRAWN,,PHASE2,0.0,ACTUAL,"Iovance Biotherapeutics, Inc.",,1.0,,The treatment landscape for NSCLC has evolved in the past year. An additional NSCLC arm will be added to the IOV-COM-202 study using TIL + pembrolizumab.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,INDUSTRY,,,,,,,2024,0.0
NCT03620747,,2018-07-26,2023-02-17,,2023-02-17,2018-08-06,2018-08-08,ACTUAL,2023-02-17,2023-03-16,ACTUAL,,,,2023-02-17,2023-03-16,ACTUAL,2018-08-30,ACTUAL,2018-08-30,2023-02,2023-02-28,2022-02-18,ACTUAL,2022-02-18,2022-02-18,ACTUAL,2022-02-18,,INTERVENTIONAL,,Analysis was performed on all enrolled participants.,Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up),"Open-label, Interventional, Cohort Study to Evaluate Long-term Safety of Dupilumab in Patients With Moderate to Severe Asthma Who Completed the TRAVERSE-LTS12551 Clinical Trial",COMPLETED,,PHASE3,393.0,ACTUAL,Sanofi,,1.0,,,,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org",2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,INDUSTRY,,,,,,,2022,1.0
NCT04978298,,2021-07-16,,,2023-08-30,2021-07-16,2021-07-27,ACTUAL,,,,,,,2023-08-30,2023-08-31,ACTUAL,2021-07-19,ACTUAL,2021-07-19,2023-08,2023-08-31,2023-02-26,ACTUAL,2023-02-26,2023-02-26,ACTUAL,2023-02-26,,INTERVENTIONAL,,,Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult Participants,"A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled Study to Evaluate the Effect of Ozanimod on Pressor Response to Oral Tyramine in Healthy Adult Subjects",COMPLETED,,PHASE1,128.0,ACTUAL,Celgene,,5.0,,,f,,,,f,t,f,,,,,,See Plan Description,See Plan Description,https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html,YES,Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/,2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,INDUSTRY,,,,,,,2023,1.0
NCT03694353,,2018-09-04,2021-11-29,,2022-02-16,2018-10-01,2018-10-03,ACTUAL,2022-02-16,2022-02-17,ACTUAL,,,,2022-02-16,2022-02-17,ACTUAL,2018-09-13,ACTUAL,2018-09-13,2022-02,2022-02-28,2021-01-13,ACTUAL,2021-01-13,2021-01-13,ACTUAL,2021-01-13,,INTERVENTIONAL,,,Safety and Efficacy of Self Administered Injections of Pegvaliase (>40mg/Day Dose) in Adults With PKU,An Open-label Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Injections of Pegvaliase (> 40 mg/Day Dose) in Adults With Phenylketonuria,COMPLETED,,PHASE3,37.0,ACTUAL,BioMarin Pharmaceutical,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,INDUSTRY,,,,,,,2021,1.0
NCT04413617,,2020-05-19,2023-02-06,,2023-03-15,2020-05-28,2020-06-04,ACTUAL,2023-03-15,2023-04-07,ACTUAL,,,,2023-03-15,2023-04-07,ACTUAL,2020-07-29,ACTUAL,2020-07-29,2023-03,2023-03-31,2022-02-07,ACTUAL,2022-02-07,2022-02-07,ACTUAL,2022-02-07,,INTERVENTIONAL,,Baseline analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received.,"TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE","A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE",COMPLETED,,PHASE2,460.0,ACTUAL,Pfizer,,5.0,,,f,,,,f,t,f,,,t,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,INDUSTRY,,,,,,,2022,1.0
NCT04475302,,2020-07-16,,,2022-07-07,2020-07-16,2020-07-17,ACTUAL,,,,,,,2022-07-07,2022-07-08,ACTUAL,2020-07-01,ACTUAL,2020-07-01,2022-07,2022-07-31,2021-09-20,ACTUAL,2021-09-20,2021-09-20,ACTUAL,2021-09-20,,INTERVENTIONAL,,,BCG Vaccine in Reducing Morbidity and Mortality in Elderly Individuals in COVID-19 Hotspots,Study to Evaluate the Effectiveness of BCG Vaccine in Reducing Morbidity and Mortality in Elderly Individuals in COVID-19 Hotspots in India,COMPLETED,,PHASE3,2175.0,ACTUAL,"Tuberculosis Research Centre, India",,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,OTHER_GOV,,,,,,,2021,1.0
NCT03530124,,2018-05-08,2022-10-31,,2024-02-12,2018-05-08,2018-05-21,ACTUAL,2022-12-19,2023-01-11,ACTUAL,,,,2024-02-12,2024-02-14,ACTUAL,2018-07-17,ACTUAL,2018-07-17,2024-02,2024-02-29,2021-11-01,ACTUAL,2021-11-01,2021-11-01,ACTUAL,2021-11-01,,INTERVENTIONAL,,,Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines,"A Prospective, Randomized, Open-label Clinical Trial to Assess Apnea Following Administration of 13-valent Conjugate Pneumococcal Vaccine, Diphtheria Toxoid, Tetanus Toxoid, and Acellular Pertussis Vaccine, Inactivated Polio Vaccine, Hepatitis B Vaccine, and Haemophilus Influenzae Type B Vaccine in Preterm Infants",COMPLETED,,PHASE4,223.0,ACTUAL,Duke University,,2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,OTHER,,,,,,,2021,1.0
NCT04154189,,2019-11-01,2023-06-20,,2024-07-19,2019-11-05,2019-11-06,ACTUAL,2023-08-03,2023-08-07,ACTUAL,,,,2024-07-19,2024-07-22,ACTUAL,2020-03-23,ACTUAL,2020-03-23,2024-07,2024-07-31,2023-08-17,ACTUAL,2023-08-17,2022-06-22,ACTUAL,2022-06-22,,INTERVENTIONAL,,Full Analysis Set (FAS) included all randomized participants regardless of the treatment actually received.,"A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma","A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination With Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults With Relapsed or Refractory Osteosarcoma (OLIE)",COMPLETED,,PHASE2,81.0,ACTUAL,Eisai Inc.,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.,2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,INDUSTRY,,,,,,,2023,1.0
NCT03848832,,2019-02-19,2021-10-14,,2022-08-31,2019-02-19,2019-02-21,ACTUAL,2021-12-01,2021-12-29,ACTUAL,,,,2022-08-31,2022-09-02,ACTUAL,2019-07-29,ACTUAL,2019-07-29,2022-08,2022-08-31,2021-01-21,ACTUAL,2021-01-21,2021-01-21,ACTUAL,2021-01-21,,INTERVENTIONAL,ARCH,One participant assigned to the 5 mg/kg/Day placebo group was misdosed with 5 mg/kg/Day GWP42003-P. The participant was included in the 5 mg/kg/Day placebo group in the Intent-to-Treat Set but was included in the 5 mg/kg/day GWP42003-P group in the Safety Analysis Set (for which Baseline data are reported).,"Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome","A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome",TERMINATED,,PHASE3,29.0,ACTUAL,Jazz Pharmaceuticals,"This study was terminated early due to enrollment challenges and the Coronavirus disease-2019 (COVID-19) pandemic. Numbers of participants in each treatment groups were small, which precluded the planned formal statistical inferences and limited data interpretation.",3.0,,The study was terminated due to enrollment challenges and the COVID-19 pandemic.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,INDUSTRY,,,,,,,2021,0.0
NCT02834793,,2016-07-13,2022-02-11,,2022-02-11,2016-07-13,2016-07-15,ESTIMATED,2022-02-11,2022-03-09,ACTUAL,,,,2022-02-11,2022-03-09,ACTUAL,2016-12-13,ACTUAL,2016-12-13,2021-03,2021-03-31,2021-07-19,ACTUAL,2021-07-19,2021-05-26,ACTUAL,2021-05-26,,INTERVENTIONAL,,The safety analysis set (SAS) was the group of participants who received at least one dose of study drug and had at least one post-dose safety assessment.,Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome,"A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 Years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome",TERMINATED,,PHASE3,101.0,ACTUAL,Eisai Inc.,"Study was terminated early by sponsor due to recruitment challenge, further impacted by COVID19, resulting in reduced sample size and variability in treatment response. Population PK analysis and PK/PD modeling planned for this study were not conducted and hence data was not collected and analyzed.",2.0,,Sponsor's decision,f,,,,f,t,f,,,,,,,,,,,2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,INDUSTRY,,,,,,,2021,0.0
NCT04784520,,2021-03-02,,,2023-02-02,2021-03-03,2021-03-05,ACTUAL,,,,,,,2023-02-02,2023-02-06,ACTUAL,2021-06-22,ACTUAL,2021-06-22,2023-02,2023-02-28,2022-12-28,ACTUAL,2022-12-28,2022-12-28,ACTUAL,2022-12-28,,INTERVENTIONAL,,,A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer,"A Multicentre, Open-label, Single-arm Phase II Study of HA121-28 Tablets in Advanced Biliary Tract Cancer (BTC)",TERMINATED,,PHASE2,31.0,ACTUAL,"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.",,1.0,,The primary endpoint did not meet expectation.,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,INDUSTRY,,,,,,,2022,0.0
NCT02481674,,2015-06-19,,,2022-04-25,2015-06-23,2015-06-25,ESTIMATED,,,,,,,2022-04-25,2022-05-02,ACTUAL,2015-07,,2015-07-31,2022-04,2022-04-30,2020-08,ACTUAL,2020-08-31,2020-08,ACTUAL,2020-08-31,,INTERVENTIONAL,SIGNAL-HD,,"A Study in Subjects With Late Prodromal & Early Manifest HD to Assess the Safety, Tolerability, pk, and Efficacy of Pepi","A Phase 2, Multi-center, Randomized, Double-blind, Placebo Controlled Study in Subjects With Late Prodromal and Early Manifest Huntington's Disease to Assess the Safety, Tolerability, pk, and Efficacy of Pepinemab",COMPLETED,,PHASE2,301.0,ACTUAL,Vaccinex Inc.,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,INDUSTRY,,,,,,,2020,1.0
NCT04631211,,2020-11-05,,,2023-05-22,2020-11-10,2020-11-17,ACTUAL,,,,,,,2023-05-22,2023-05-25,ACTUAL,2021-03-05,ACTUAL,2021-03-05,2023-05,2023-05-31,2022-01-07,ACTUAL,2022-01-07,2022-01-07,ACTUAL,2022-01-07,,INTERVENTIONAL,,,Thrombosomes® in Bleeding Thrombocytopenic Patients Study,"A Prospective, Multicenter, Randomized, Open-Label Phase 2, Parallel, Dose Ranging Multidose Study of Thrombosomes® vs Liquid Stored Platelets (LSP) in Bleeding Thrombocytopenic Patients",TERMINATED,,PHASE2,21.0,ACTUAL,"Cellphire Therapeutics, Inc.",,4.0,,This study was terminated due to loss of funding for this indication from the Biomedical Advanced Research and Development Authority (BARDA) in November 2022.,t,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,INDUSTRY,,NCT04619108,NO_LONGER_AVAILABLE,,,,2022,0.0
NCT04273737,,2020-02-14,2022-03-24,,2022-05-27,2020-02-14,2020-02-18,ACTUAL,2022-05-27,2022-05-31,ACTUAL,,,,2022-05-27,2022-05-31,ACTUAL,2020-02-28,ACTUAL,2020-02-28,2022-05,2022-05-31,2022-02-22,ACTUAL,2022-02-22,2022-02-22,ACTUAL,2022-02-22,,INTERVENTIONAL,,All participants who were enrolled.,Amantadine in Treating Cognitive & Motor Impairments in Adolescents and Adults With Cerebral Palsy,Use of Amantadine in Treating Cognitive and Motor Impairments in Adolescents and Adults With Cerebral Palsy,TERMINATED,,PHASE4,11.0,ACTUAL,Columbia University,,1.0,,PI left institution.,f,,,,f,t,f,,,f,,,,,,UNDECIDED,,2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,OTHER,,,,,,,2022,0.0
NCT04406857,,2020-05-28,2023-06-01,,2023-10-03,2020-05-28,2020-05-29,ACTUAL,2023-10-03,2023-10-05,ACTUAL,,,,2023-10-03,2023-10-05,ACTUAL,2021-03-17,ACTUAL,2021-03-17,2023-10,2023-10-31,2023-01-18,ACTUAL,2023-01-18,2023-01-18,ACTUAL,2023-01-18,,INTERVENTIONAL,,,"Testing the Addition of a Radiation Sensitizing Drug, IPdR, to the Usual Chemotherapy Treatment (Capecitabine) During Radiation Therapy for Rectal Cancer",A Phase 1 Study of IPdR in Combination With Capecitabine and Radiotherapy in Rectal Cancer,TERMINATED,,PHASE1,1.0,ACTUAL,National Cancer Institute (NCI),Trial had inadequate accrual rate,1.0,,Inadequate accrual rate,f,,,,f,t,f,,,,,,,,https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.",2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,NIH,,,,,,,2023,0.0
NCT04490096,,2020-06-24,,,2022-04-04,2020-07-27,2020-07-28,ACTUAL,,,,,,,2022-04-04,2022-04-12,ACTUAL,2021-02-25,ACTUAL,2021-02-25,2022-04,2022-04-30,2022-03-17,ACTUAL,2022-03-17,2022-03-17,ACTUAL,2022-03-17,,INTERVENTIONAL,,,Multimodal Imaging Outcome Measures for ALS (Image ALS),Multimodal Imaging Outcome Measures for ALS (Image ALS),TERMINATED,,PHASE1,2.0,ACTUAL,University of Pennsylvania,,1.0,,Funding issues.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,OTHER,,,,,,,2022,0.0
NCT04421027,,2020-06-05,2022-02-11,,2022-07-27,2020-06-05,2020-06-09,ACTUAL,2022-03-14,2022-03-24,ACTUAL,,,,2022-07-27,2022-07-28,ACTUAL,2020-06-12,ACTUAL,2020-06-12,2022-07,2022-07-31,2021-06-10,ACTUAL,2021-06-10,2021-02-12,ACTUAL,2021-02-12,,INTERVENTIONAL,COV-BARRIER,All participants randomly assigned to study intervention. Participants were analyzed according to the intervention to which they were assigned.,A Study of Baricitinib (LY3009104) in Participants With COVID-19,"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Baricitinib in Patients With COVID-19 Infection",COMPLETED,,PHASE3,1525.0,ACTUAL,Eli Lilly and Company,,2.0,,,f,,,,t,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting","Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting",http://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement,2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,INDUSTRY,,,,,,,2021,1.0
NCT01397968,,2011-07-18,2020-08-20,2014-11-17,2022-04-08,2011-07-19,2011-07-20,ESTIMATED,2022-04-08,2022-04-11,ACTUAL,2014-11-17,2014-12-03,ESTIMATED,2022-04-08,2022-04-11,ACTUAL,2011-07-06,ACTUAL,2011-07-06,2022-04,2022-04-30,2021-01-28,ACTUAL,2021-01-28,2013-06,ACTUAL,2013-06-30,,INTERVENTIONAL,,,Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures,"A Phase 2 Multicenter, Double-blind, Randomized, Adjunctive, Placebo-controlled Trial With an Open-label Extension to Evaluate the Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures",COMPLETED,,PHASE2,222.0,ACTUAL,"SK Life Science, Inc.",,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,INDUSTRY,,,,,,,2021,1.0
NCT03440385,,2018-02-14,,,2023-12-05,2018-02-14,2018-02-22,ACTUAL,,,,,,,2023-12-05,2023-12-12,ACTUAL,2018-03-07,ACTUAL,2018-03-07,2023-12,2023-12-31,2023-11-21,ACTUAL,2023-11-21,2023-11-21,ACTUAL,2023-11-21,,INTERVENTIONAL,,,Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease,"Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease",COMPLETED,,PHASE3,606.0,ACTUAL,Celgene,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,INDUSTRY,,,,,,,2023,0.0
NCT02835079,,2016-06-22,,,2022-07-21,2016-07-13,2016-07-15,ESTIMATED,,,,,,,2022-07-21,2022-07-25,ACTUAL,2016-11,ACTUAL,2016-11-30,2022-07,2022-07-31,2020-11,ACTUAL,2020-11-30,2020-11,ACTUAL,2020-11-30,,INTERVENTIONAL,,,Treatment Effect of Tamoxifen on Patients With DMD,Treatment Effect of Tamoxifen on Patients With DMD,COMPLETED,,PHASE1,19.0,ACTUAL,Hadassah Medical Organization,,1.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 05:44:31.206366,2024-10-15 05:44:31.206366,OTHER,,,,,,,2020,1.0
NCT03770767,,2018-12-06,,,2023-05-04,2018-12-06,2018-12-10,ACTUAL,,,,,,,2023-05-04,2023-05-06,ACTUAL,2019-11-11,ACTUAL,2019-11-11,2023-05,2023-05-31,2023-03-23,ACTUAL,2023-03-23,2023-03-23,ACTUAL,2023-03-23,,INTERVENTIONAL,,,Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes,A Randomised Controlled Trial Comparing the Effect of the Faster-acting Insulin Analog - Insulin Fiasp® - Versus Insulin Novorapid® in the Treatment of Women With Type 1 or Type 2 Diabetes During Pregnancy and Lactation. The Copen-fast Trial,COMPLETED,,PHASE3,216.0,ACTUAL,"Rigshospitalet, Denmark",,2.0,,,f,,,,,f,f,,,,,,,,,NO,Baseline data can be shared upon request.,2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,OTHER,,,,,,,2023,1.0
NCT02136069,,2014-04-15,2021-06-18,,2021-12-01,2014-05-08,2014-05-12,ESTIMATED,2021-07-21,2021-08-13,ACTUAL,,,,2021-12-01,2021-12-03,ACTUAL,2014-12-24,ACTUAL,2014-12-24,2021-12,2021-12-31,2020-06-23,ACTUAL,2020-06-23,2020-06-23,ACTUAL,2020-06-23,,INTERVENTIONAL,GARDENIA,,A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors,"Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors",COMPLETED,,PHASE3,397.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).~For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,INDUSTRY,,,,,,,2020,1.0
NCT04371393,,2020-04-28,,,2022-04-18,2020-04-28,2020-05-01,ACTUAL,,,,,,,2022-04-18,2022-04-25,ACTUAL,2020-04-30,ACTUAL,2020-04-30,2022-04,2022-04-30,2022-01-02,ACTUAL,2022-01-02,2021-01-14,ACTUAL,2021-01-14,,INTERVENTIONAL,,,MSCs in COVID-19 ARDS,Mesenchymal Stromal Cells for the Treatment of Moderate to Severe COVID-19 Acute Respiratory Distress Syndrome,TERMINATED,,PHASE3,223.0,ACTUAL,Icahn School of Medicine at Mount Sinai,,2.0,,"At 3d interim analysis, randomization, but not follow-up, was halted by the DSMB due to low predictive probability of achieving postulated mortality benefit (pre-specified 42.5% relative mortality reduction) were the trial to complete randomization.",f,,,,t,t,f,,,,,,"De-identified study data sets must be submitted to the designated NHLBI Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the designated PO for review prior to release.",Anyone who wishes to access the data.,,YES,"All of the individual participant data collected during the trial, after deidentification.",2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,OTHER,,,,,,,2022,0.0
NCT04254380,,2020-01-13,,,2020-02-02,2020-02-02,2020-02-05,ACTUAL,,,,,,,2020-02-02,2020-02-05,ACTUAL,2019-12-04,ACTUAL,2019-12-04,2020-02,2020-02-29,2020-01-27,ACTUAL,2020-01-27,2020-01-27,ACTUAL,2020-01-27,,INTERVENTIONAL,GENTL 1,,Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro,"An Open-label, Randomized, Multicenter, Phase 3 Study to Compare the Immunogenicity, Efficacy, and Safety of Gan & Lee Insulin Lispro Injection to Humalog in Adult Subjects With Type 1 Diabetes Mellitus (T1DM)",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Gan and Lee Pharmaceuticals, USA",,2.0,,GanLee cancelled study -FDA Draft Guidance: Clinical Immunogenicity Considerations for Biosimilar \& Interchangeable Insulin Products released 11/25/2019,,,,,f,t,f,,,,,,,,,NO,,2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,INDUSTRY,,,,,,,2020,0.0
NCT05643573,,2022-11-30,,,2024-08-15,2022-11-30,2022-12-08,ACTUAL,,,,,,,2024-08-15,2024-08-19,ACTUAL,2022-12-05,ACTUAL,2022-12-05,2024-08,2024-08-31,2024-01-31,ACTUAL,2024-01-31,2024-01-31,ACTUAL,2024-01-31,,INTERVENTIONAL,OCEANIC-AF,,"A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke","A Multicenter, International, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel-group, 2-arm, Phase 3 Study to Compare the Efficacy and Safety of the Oral FXIa Inhibitor Asundexian (BAY 2433334) With Apixaban for the Prevention of Stroke or Systemic Embolism in Male and Female Participants Aged 18 Years and Older With Atrial Fibrillation at Risk for Stroke",TERMINATED,,PHASE3,14830.0,ACTUAL,Bayer,,2.0,,Independent Data Monitoring Committee (IDMC) recommendation to stop the study,f,,,,t,t,f,,,,,,,,,NO,"Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.",2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,INDUSTRY,,,,,,,2024,0.0
NCT04398927,,2020-05-19,,,2021-02-01,2020-05-19,2020-05-22,ACTUAL,,,,,,,2021-02-01,2021-02-04,ACTUAL,2020-05-01,ACTUAL,2020-05-01,2020-05,2020-05-31,2021-02-01,ACTUAL,2021-02-01,2021-01-01,ACTUAL,2021-01-01,,INTERVENTIONAL,,,Systemic Chemotherapy Plus PD-1 for Metastasis ICC,Systemic Chemotherapy Based on Oxaliplatin and 5-fluorouracil Plus PD-1 for Metastasis ICC-single Arm Prospective Study,WITHDRAWN,,PHASE2,0.0,ACTUAL,Sun Yat-sen University,,1.0,,no patient enrolled,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,OTHER,,,,,,,2021,0.0
NCT01525069,,2012-01-25,,,2022-08-08,2012-01-30,2012-02-02,ESTIMATED,,,,,,,2022-08-08,2022-08-10,ACTUAL,2012-04-03,ACTUAL,2012-04-03,2022-08,2022-08-31,2022-08-02,ACTUAL,2022-08-02,2018-08-08,ACTUAL,2018-08-08,,INTERVENTIONAL,,,"Hepatic Arterial Infusion in Treating Patients With Locally Advanced, Non-Metastatic Cholangiocarcinoma",Pilot Study of Hepatic Arterial Infusion Therapy in Patients With Unresectable or Borderline Resectable Intrahepatic Cholangiocarcinoma,TERMINATED,,PHASE1,27.0,ACTUAL,Washington University School of Medicine,,3.0,,Equipment that was used in the study was discontinued,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,OTHER,,,,,,,2022,0.0
NCT03710161,,2018-10-15,2021-04-27,,2023-11-28,2018-10-15,2018-10-18,ACTUAL,2021-05-18,2021-06-14,ACTUAL,,,,2023-11-28,2023-12-01,ACTUAL,2019-07-08,ACTUAL,2019-07-08,2023-11,2023-11-30,2020-03-13,ACTUAL,2020-03-13,2020-03-13,ACTUAL,2020-03-13,,INTERVENTIONAL,,,Effect of Vitamin D Supplementation on Balance in CKD,Effect of Vitamin D Supplementation on Balance in Patients With Chronic Kidney Disease,TERMINATED,,PHASE4,5.0,ACTUAL,University of Nebraska,,2.0,,Study was stopped due to the COVID pandemic,f,,,,f,t,f,,,,,,,,,NO,De -identified data will be published as supplementary data to manuscripts.,2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,OTHER,,,,,,,2020,0.0
NCT04400890,,2020-05-22,2022-06-30,,2023-02-22,2020-05-22,2020-05-26,ACTUAL,2023-02-22,2023-02-24,ACTUAL,,,,2023-02-22,2023-02-24,ACTUAL,2020-09-13,ACTUAL,2020-09-13,2023-02,2023-02-28,2021-03-01,ACTUAL,2021-03-01,2021-03-01,ACTUAL,2021-03-01,,INTERVENTIONAL,,"Between September 13, 2020 and December 11, 2020, 1,694 patients were telephoned within 24-h of testing positive for COVID-19 to be recruited into the clinical trial . One-hundred-five were enrolled and randomized. Five withdrew after receiving treatment packets (four withdrew before starting treatment and one withdrew after one treatment day citing too many pills as reason for withdrawal).","Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol, a Plant Polyphenol, for COVID-19","Randomized Double-Blind Placebo-Controlled Proof-of-Concept Trial of Resveratrol, a Plant Polyphenol, for the Outpatient Treatment of Mild Coronavirus Disease (COVID-19)",TERMINATED,,PHASE2,105.0,ACTUAL,Mount Carmel Health System,The actual rate of primary and secondary COVID-19 outcome measures were lower than expected. Therefore the study plan had inadequate number of participants and was therefore under-powered.,2.0,,Feasibility,f,,,,t,t,f,,,,,,,,,YES,,2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,OTHER,,,,,,,2021,0.0
NCT03514017,,2018-04-20,2023-08-28,,2024-08-01,2018-04-20,2018-05-02,ACTUAL,2023-08-28,2023-09-25,ACTUAL,,,,2024-08-01,2024-08-05,ACTUAL,2019-05-31,ACTUAL,2019-05-31,2024-07,2024-07-31,2023-05-16,ACTUAL,2023-05-16,2023-05-16,ACTUAL,2023-05-16,,INTERVENTIONAL,,,Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia,Phase II Trial of Ibrutinib and PD-1 Blockade in High Risk Chronic Lymphocytic Leukemia to Improve Immune Dysfunction,TERMINATED,,PHASE2,5.0,ACTUAL,H. Lee Moffitt Cancer Center and Research Institute,,1.0,,Funding unavailable,,,,,f,t,f,,,,,,,,,,,2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,OTHER,,,,,,,2023,0.0
NCT04334174,,2020-03-20,,,2023-02-01,2020-04-02,2020-04-06,ACTUAL,,,,,,,2023-02-01,2023-02-03,ACTUAL,2020-05-29,ACTUAL,2020-05-29,2023-02,2023-02-28,2023-02-01,ACTUAL,2023-02-01,2022-12-14,ACTUAL,2022-12-14,,INTERVENTIONAL,BRENTICON-T,,Study of Brentuximab Vedotin as Therapy After Autologous Stem Cell Transplant in Cluster of Differentiation Antigen 30 (CD30) Positive Peripheral TCell Lymphomas,"A Phase II Single Arm Proof of Concept, Safety, Efficacy, Multicenter Study of Brentuximab Vedotin as Consolidation Therapy After Autologous Stem Cell Transplant in CD30 Expressing Peripheral T Cell Lymphomas",WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Kansas Medical Center,,1.0,,accrual not met,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,OTHER,,,,,,,2023,0.0
NCT03503318,,2018-04-09,2021-09-23,,2023-02-08,2018-04-18,2018-04-19,ACTUAL,2021-11-11,2021-12-09,ACTUAL,,,,2023-02-08,2023-03-10,ACTUAL,2018-04-27,ACTUAL,2018-04-27,2023-02,2023-02-28,2020-12-03,ACTUAL,2020-12-03,2020-09-30,ACTUAL,2020-09-30,,INTERVENTIONAL,RISE,"Extended intent-to-treat (eITT) analysis set included all participants (adults and adolescents) randomized to the double-blind maintenance stage treatment, regardless if they had received treatment or not.",Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use as Maintenance Treatment in Adult and Adolescent Patients With Schizophrenia",COMPLETED,,PHASE3,544.0,ACTUAL,"Teva Branded Pharmaceutical Products R&D, Inc.",,3.0,,,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.)",2024-10-16 15:30:04.400687,2024-10-16 15:30:04.400687,INDUSTRY,,,,,,,2020,1.0
NCT03835286,,2019-01-22,,,2024-01-16,2019-02-07,2019-02-08,ACTUAL,,,,,,,2024-01-16,2024-01-18,ACTUAL,2019-03-01,ACTUAL,2019-03-01,2024-01,2024-01-31,2022-12,ESTIMATED,2022-12-31,2022-12,ESTIMATED,2022-12-31,,INTERVENTIONAL,ViCiS,,Vitamin C to Reduce Vasopressor Dose in Septic Shock,Vitamin C to Reduce Exogenous Vasopressor Dose in Septic Shock; a Randomized Clinical Trial,WITHDRAWN,,PHASE3,0.0,ACTUAL,Hospital Español de Mexico,,2.0,,COVID 19,f,,,,f,f,f,,,,,,Available one year after,Journal provided,,YES,"Complete database will be shared as requested by the publishing journal, once the study is completed",2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,OTHER,,,,,,,2022,0.0
NCT05820685,,2023-04-06,,,2024-05-21,2023-04-06,2023-04-20,ACTUAL,,,,,,,2024-05-21,2024-05-23,ACTUAL,2023-07-27,ACTUAL,2023-07-27,2024-05,2024-05-31,2024-10-30,ESTIMATED,2024-10-30,2024-10-01,ESTIMATED,2024-10-01,,INTERVENTIONAL,DOPE,,Dronabinol On the Pain Experience,Dronabinol On the Pain Experience (DOPE): a Pragmatic Randomized Clinical Trial,SUSPENDED,,PHASE4,664.0,ESTIMATED,"The University of Texas Health Science Center, Houston",,2.0,,Study paused because drug shortage,f,,,,,t,f,,,f,,,,,,NO,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,OTHER,,,,,,,2024,0.0
NCT04132011,,2019-10-02,,,2020-03-25,2019-10-17,2019-10-18,ACTUAL,,,,,,,2020-03-25,2020-03-27,ACTUAL,2019-05-01,ACTUAL,2019-05-01,2019-09,2019-09-30,2020-03-08,ACTUAL,2020-03-08,2020-03-08,ACTUAL,2020-03-08,,INTERVENTIONAL,,,Dosing Intervals of Opioid Medication for Chronic Pain,"Examining the Relationship Amongst Opioid Subjective Effects and Pharmacokinetics of Extended Release Opioids at Shortened Dosing Intervals in Patients With Chronic Pain: a Randomized, Blinded, N-of-1 Case Series Feasibility Study",WITHDRAWN,,PHASE4,0.0,ACTUAL,"University Health Network, Toronto",,2.0,,No recruitment (Feasibility study).,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,OTHER,,,,,,,2020,0.0
NCT03872128,,2019-02-01,2023-10-31,,2024-02-01,2019-03-11,2019-03-13,ACTUAL,2023-12-14,2023-12-15,ACTUAL,,,,2024-02-01,2024-02-05,ACTUAL,2018-09-27,ACTUAL,2018-09-27,2024-02,2024-02-29,2023-08-01,ACTUAL,2023-08-01,2022-11-01,ACTUAL,2022-11-01,,INTERVENTIONAL,,Data represented here is from participants that started treatment.,"The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders","The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders",COMPLETED,,PHASE1,91.0,ACTUAL,Yale University,,3.0,,,f,,,,f,t,f,,,t,,,,,,,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,OTHER,,,,,,,2023,1.0
NCT03956862,,2019-05-17,2021-07-08,,2021-08-19,2019-05-17,2019-05-21,ACTUAL,2021-07-08,2021-07-30,ACTUAL,,,,2021-08-19,2021-08-23,ACTUAL,2019-05-16,ACTUAL,2019-05-16,2021-08,2021-08-31,2020-08-05,ACTUAL,2020-08-05,2020-07-09,ACTUAL,2020-07-09,,INTERVENTIONAL,,,GB001 in Adult Participants With Chronic Rhinosinusitis,"A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Effect of GB001 in Patients With Chronic Rhinosinusitis With or Without Nasal Polyps",COMPLETED,,PHASE2,97.0,ACTUAL,Gossamer Bio Inc.,,2.0,,,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,INDUSTRY,,,,,,,2020,1.0
NCT04166734,,2019-11-08,,,2023-08-03,2019-11-15,2019-11-18,ACTUAL,,,,,,,2023-08-03,2023-08-07,ACTUAL,2021-01-26,ACTUAL,2021-01-26,2023-08,2023-08-31,2023-07-25,ACTUAL,2023-07-25,2023-07-25,ACTUAL,2023-07-25,,INTERVENTIONAL,MESO-PRIME,,Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma,Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma,TERMINATED,,PHASE1,3.0,ACTUAL,Royal Marsden NHS Foundation Trust,,2.0,,Study terminated due to slow recruitment and insufficient further funding.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,OTHER,,,,,,,2023,0.0
NCT04480086,,2020-07-20,,,2023-08-25,2020-07-20,2020-07-21,ACTUAL,,,,,,,2023-08-25,2023-08-29,ACTUAL,2021-03-17,ACTUAL,2021-03-17,2023-08,2023-08-31,2023-07-28,ACTUAL,2023-07-28,2023-07-28,ACTUAL,2023-07-28,,INTERVENTIONAL,,,Safety and Tolerability Study of Mivebresib Tablet Alone or in Combination With Ruxolitinib Tablet or Navitoclax Tablet in Adult Participants With Myelofibrosis,A Phase 1b Study of Mivebresib Alone or in Combination With Ruxolitinib or Navitoclax in Subjects With Myelofibrosis,TERMINATED,,PHASE1,1.0,ACTUAL,AbbVie,,5.0,,Strategic considerations,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,INDUSTRY,,,,,,,2023,0.0
NCT03803774,,2019-01-14,2024-07-01,,2024-07-24,2019-01-14,2019-01-15,ACTUAL,2024-07-01,2024-07-23,ACTUAL,,,,2024-07-24,2024-08-20,ACTUAL,2019-09-25,ACTUAL,2019-09-25,2024-07,2024-07-31,2023-12-29,ACTUAL,2023-12-29,2023-11-15,ACTUAL,2023-11-15,,INTERVENTIONAL,,,Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma,Birinapant and Intensity Modulated Re-Irradiation Therapy (IMRRT) for Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC),TERMINATED,,PHASE1,13.0,ACTUAL,National Cancer Institute (NCI),,1.0,,Drug supply issues,f,,,,f,t,f,,,,,,Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.,"Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).~Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.~Requests for all collected individual participant data (IPD) data from clinical trials, conducted under a binding collaborative agreement between National Cancer Institute (NCI)/Division of Cancer Treatment and Diagnosis (DCTD) and a pharmaceutical/biotechnology company, that are not under Data and Safety Monitoring Board (DSMB) monitoring must be in compliance with the terms of the binding collaborative agreement and must be approved by NCI/DCTD and the Pharmaceutical Collaborator (i.e., the NCI Experimental Therapeutics Clinical Trials Network (ETCTN) Director in conjunction with the NCI/DCTD Regulatory Affairs Branch).",https://grants.nih.gov/policy/sharing.htm,YES,"NCI is committed to sharing data in accordance with National Institutes of Health (NIH) policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page. All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.~In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).",2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,NIH,,,,,,,2023,0.0
NCT04043377,,2019-07-23,,,2022-06-29,2019-08-01,2019-08-02,ACTUAL,,,,,,,2022-06-29,2022-06-30,ACTUAL,2019-11-21,ACTUAL,2019-11-21,2022-06,2022-06-30,2021-09-13,ACTUAL,2021-09-13,2021-09-13,ACTUAL,2021-09-13,,INTERVENTIONAL,iPROGRESS,,68Ga-DOTATATE PET-CTA Imaging for the Early Detection of Progressing Coronary Atherosclerosis,68Ga-DOTATATE PET-CTA Imaging for the Early Detection of Progressing Coronary Atherosclerosis,TERMINATED,,PHASE3,12.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,1.0,,Financial issues,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,OTHER,,,,,,,2021,0.0
NCT03601819,,2018-07-18,,,2021-01-20,2018-07-18,2018-07-26,ACTUAL,,,,,,,2021-01-20,2021-01-22,ACTUAL,2019-05-15,ACTUAL,2019-05-15,2021-01,2021-01-31,2020-07-17,ACTUAL,2020-07-17,2020-03-07,ACTUAL,2020-03-07,,INTERVENTIONAL,,,Pacritinib in Relapsed/Refractory Lymphoproliferative Disorders,"Phase Ib, Open Label, Single Center Study of Pacritinib in Relapsed/Refractory Lymphoproliferative Disorders",TERMINATED,,PHASE1,4.0,ACTUAL,University of Michigan Rogel Cancer Center,,1.0,,Low accrual,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,OTHER,,,,,,,2020,0.0
NCT03972683,,2019-05-31,,,2021-07-26,2019-05-31,2019-06-04,ACTUAL,,,,,,,2021-07-26,2021-08-02,ACTUAL,2019-04-16,ACTUAL,2019-04-16,2021-07,2021-07-31,2021-07-31,ESTIMATED,2021-07-31,2021-07-31,ESTIMATED,2021-07-31,,INTERVENTIONAL,,,Role of Acetylcholine in Blood Flow Regulation in Healthy Adults: Effects of Age and Exercise Training,Novel Role of Acetylcholine in Regulating Vascular Tone: Effects of Age and Exercise Training,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Colorado State University,,1.0,,no participants enrolled,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,OTHER,,,,,,,2021,0.0
NCT02504333,,2015-07-20,,,2023-09-29,2015-07-20,2015-07-21,ESTIMATED,,,,,,,2023-09-29,2023-10-03,ACTUAL,2015-07,,2015-07-31,2023-09,2023-09-30,2021-04,ACTUAL,2021-04-30,2021-04,ACTUAL,2021-04-30,,INTERVENTIONAL,SEQUENCE,,Phase I/II Study of Nab-paclitaxel and Gemcitabine Followed by AG-mFOLFOX in Patients With Metastatic Pancreatic Adenocarcinoma,"A Phase I/II Study of Nab-paclitaxel (Abraxane) and Gemcitabine Followed by Modified FOLFOX (AG-mFOLFOX) in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma",COMPLETED,,PHASE1/PHASE2,168.0,ACTUAL,Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD),,2.0,,,f,,,,f,,,,,,,,,,,,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,OTHER,,,,,,,2021,1.0
NCT04206332,,2019-12-19,2023-02-27,,2023-04-13,2019-12-19,2019-12-20,ACTUAL,2023-04-13,2023-04-18,ACTUAL,,,,2023-04-13,2023-04-18,ACTUAL,2020-01-07,ACTUAL,2020-01-07,2023-04,2023-04-30,2022-02-28,ACTUAL,2022-02-28,2022-02-28,ACTUAL,2022-02-28,,INTERVENTIONAL,,"A total of 71 participants enrolled; however, 10 participants previously enrolled in Part A and who were later enrolled in Part B are counted twice (once in Part A and again in Part B).",Trial to Evaluate CIS43LS in Healthy Adults,"A Phase 1, Dose Escalation, Open-Label Clinical Trial With Experimental Controlled Human Malaria Infections (CHMI) to Evaluate Safety and Protective Efficacy of an Anti-Malaria Human Monoclonal Antibody, VRC-MALMAB0100-00-AB (CIS43LS), in Healthy, Malaria-Naive Adults",COMPLETED,,PHASE1,71.0,ACTUAL,National Institutes of Health Clinical Center (CC),,17.0,,,f,,,,f,t,f,,,,,,,,,NO,Individual participant data (IPD) is not shared because it has limited value in a small phase 1 trial of healthy volunteers. We instead report non-IPD data as required in ClinicalTrials.gov.,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,NIH,,,,,,,2022,1.0
NCT03848286,,2019-02-12,,,2023-10-19,2019-02-19,2019-02-20,ACTUAL,,,,,,,2023-10-19,2023-10-23,ACTUAL,2019-03-06,ACTUAL,2019-03-06,2022-03,2022-03-31,2022-01-13,ACTUAL,2022-01-13,2021-07-13,ACTUAL,2021-07-13,,INTERVENTIONAL,,,KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma,A Phase 2 Clinical Study To Evaluate the Efficacy and Safety of KL-A167 Injection in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC),COMPLETED,,PHASE2,153.0,ACTUAL,"Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.",,1.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,INDUSTRY,,,,,,,2022,1.0
NCT05217472,,2020-02-06,,,2022-01-20,2022-01-20,2022-02-01,ACTUAL,,,,,,,2022-01-20,2022-02-01,ACTUAL,2020-03-06,ESTIMATED,2020-03-06,2020-02,2020-02-29,2022-05-15,ESTIMATED,2022-05-15,2022-04-15,ESTIMATED,2022-04-15,,INTERVENTIONAL,,,An Efficacy and Safety Study of Injectable Ravagalimab to Assess Change in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) in Adult Participants With Moderately to Severely Active Primary Sjogren's Syndrome (pSS),"A Phase 2a, Double-Blind, Randomized, Placebo-Controlled Study of Ravagalimab in Subjects With Moderately to Severely Active Primary Sjogren's Syndrome",WITHDRAWN,,PHASE2,0.0,ACTUAL,AbbVie,,2.0,,Study canceled,f,,,,t,t,f,,,t,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,INDUSTRY,,,,,,,2022,0.0
NCT02514382,,2015-07-30,,,2023-08-09,2015-07-30,2015-08-03,ESTIMATED,,,,,,,2023-08-09,2023-08-14,ACTUAL,2015-08-21,ACTUAL,2015-08-21,2023-08,2023-08-31,2022-04-19,ACTUAL,2022-04-19,2022-04-19,ACTUAL,2022-04-19,,INTERVENTIONAL,,,"Wild-Type Reovirus, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma",A Phase 1b Study of REOLYSIN® (Reovirus Serotype 3 - Dearing Strain) Combined With Standard Doses of Bortezomib and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma,COMPLETED,,PHASE1,14.0,ACTUAL,University of Southern California,,1.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,OTHER,,,,,,,2022,1.0
NCT03714880,,2018-10-17,2022-03-30,,2022-06-07,2018-10-18,2018-10-22,ACTUAL,2022-06-07,2022-06-08,ACTUAL,,,,2022-06-07,2022-06-08,ACTUAL,2019-04-26,ACTUAL,2019-04-26,2022-06,2022-06-30,2021-02-26,ACTUAL,2021-02-26,2021-02-26,ACTUAL,2021-02-26,,INTERVENTIONAL,,,Cervical Preparation With Mifepristone Prior to Osmotic Dilators,"Cervical Preparation With Mifepristone Prior to Osmotic Dilators: A Randomized, Double-blind, Placebo-controlled Pilot Study",TERMINATED,,PHASE2,44.0,ACTUAL,"University of California, Davis",,2.0,,Slow recruitment compounded by COVID-19,f,,,,f,t,f,,,t,,,,,,,,2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,OTHER,,,,,,,2021,0.0
NCT04834128,,2021-03-29,,,2023-04-20,2021-04-05,2021-04-06,ACTUAL,,,,,,,2023-04-20,2023-04-21,ACTUAL,2021-12-13,ACTUAL,2021-12-13,2023-04,2023-04-30,2022-04-13,ACTUAL,2022-04-13,2022-04-13,ACTUAL,2022-04-13,,INTERVENTIONAL,,,A Phase II Safety and Tolerability Study of TCB008 in Patients With COVID-19,"A Phase II Safety and Tolerability, Inter-patient Pre-defined Dose Study of Ex-vivo Expanded Allogeneic γδ T-lymphocytes (TCB008) in Patients Diagnosed With COVID-19",WITHDRAWN,,PHASE2,0.0,ACTUAL,TC Biopharm,,1.0,,"The study was stopped because of the current status of the COVID-19 epidemic in the United Kingdom, and also because the trial involved parenterally administered IMP and a period of inpatient care and extensive outpatient visits and investigations.",f,,,,t,f,f,,,,,,,,,,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,INDUSTRY,,,,,,,2022,0.0
NCT04109885,,2019-09-27,,,2024-07-31,2019-09-30,2019-10-01,ACTUAL,,,,,,,2024-07-31,2024-08-01,ACTUAL,2020-09-15,ACTUAL,2020-09-15,2024-07,2024-07-31,2024-01-30,ACTUAL,2024-01-30,2024-01-30,ACTUAL,2024-01-30,,INTERVENTIONAL,,,Paracervical Injection for Headache in the Emergency Department,Intramuscular Paracervical Injection for Headache in the Emergency Department: A Randomized Controlled Trial,TERMINATED,,PHASE2,19.0,ACTUAL,Albert Einstein Healthcare Network,,2.0,,Insufficient recruitment.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,OTHER,,,,,,,2024,0.0
NCT05241613,,2022-01-17,,,2024-03-28,2022-02-04,2022-02-16,ACTUAL,,,,,,,2024-03-28,2024-04-01,ACTUAL,2022-03-16,ACTUAL,2022-03-16,2024-03,2024-03-31,2024-03-05,ACTUAL,2024-03-05,2024-03-05,ACTUAL,2024-03-05,,INTERVENTIONAL,,,A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer,"A Phase I Study to Evaluate Safety, Tolerability, PK, Pharmacodynamics, and Preliminary Anti-Tumor Activity of AC176 in Patients With Metastatic Castration Resistant Prostate Cancer Who Have Progressed on at Least Two Prior Systemic Therapies",TERMINATED,,PHASE1,28.0,ACTUAL,Accutar Biotechnology Inc,,1.0,,"Subject benefit-risk ratio changes, sponsor decides to voluntarily terminate study",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,INDUSTRY,,,,,,,2024,0.0
NCT03287908,,2017-09-06,,,2023-10-10,2017-09-15,2017-09-19,ACTUAL,,,,,,,2023-10-10,2023-10-12,ACTUAL,2017-11-13,ACTUAL,2017-11-13,2023-10,2023-10-31,2023-06-30,ACTUAL,2023-06-30,2023-06-30,ACTUAL,2023-06-30,,INTERVENTIONAL,,,"A Study to Assess AMG 701 Montherapy, or in Combination With Pomalidomide, With or Without, Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma","A Phase 1/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 701 Monotherapy, or in Combination With Pomalidomide, With and Without Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (ParadigMM-1B)",TERMINATED,,PHASE1,174.0,ACTUAL,Amgen,,3.0,,"business decision, not safety reasons.",f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.,2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,INDUSTRY,,,,,,,2023,0.0
NCT02758665,,2016-04-06,,,2023-01-13,2016-04-29,2016-05-02,ESTIMATED,,,,,,,2023-01-13,2023-01-17,ACTUAL,2016-09,ACTUAL,2016-09-30,2023-01,2023-01-31,2022-03,ACTUAL,2022-03-31,2022-01,ACTUAL,2022-01-31,,INTERVENTIONAL,CLL2-GiVe,,Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Patients With CLL,"A Prospective, Open-label, Multicentre Phase-II Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Physically Fit or Unfit Patients With Previously Untreated Chronic Lymphocytic Leukemia (Cll) With tp53 Deletion (17p-) and/or Mutation",COMPLETED,,PHASE2,41.0,ACTUAL,University of Ulm,,1.0,,,f,,,,f,,,,,,,,,,,YES,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,OTHER,,,,,,,2022,1.0
NCT03059615,,2017-02-09,,,2020-07-29,2017-02-16,2017-02-23,ACTUAL,,,,,,,2020-07-29,2020-07-31,ACTUAL,2018-10-25,ACTUAL,2018-10-25,2020-07,2020-07-31,2020-07-26,ACTUAL,2020-07-26,2020-07-26,ACTUAL,2020-07-26,,INTERVENTIONAL,,,"A Phase 2a, Open-Label, Two Stage Study of Nerofe or Nerofe With Doxorubicin in Subjects With AML or MDS","A Phase 2a, Open-Label, Two Stage Study: Stage A: Dose-Range Finder Study to Assess the Safety and Efficacy of Two Doses of Nerofe and Two Doses of Nerofe in Combination With Doxorubicin in Subjects With Acute Myelogenous Leukemia or High Risk Myelodysplastic Syndrome (AML/High Risk MDS). Stage B: Dose Confirmation Study to Assess the Safety and Efficacy of Nerofe or Nerofe in Combination With Doxorubicin in Subjects With AML/ High Risk MDS",WITHDRAWN,,PHASE2,0.0,ACTUAL,Immune System Key Ltd,,4.0,,No recruitment since initiation,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,INDUSTRY,,,,,,,2020,0.0
NCT04200352,,2019-12-12,2024-01-26,,2024-04-10,2019-12-12,2019-12-16,ACTUAL,2024-04-10,2024-04-22,ACTUAL,,,,2024-04-10,2024-04-22,ACTUAL,2020-02-04,ACTUAL,2020-02-04,2024-04,2024-04-30,2023-02-14,ACTUAL,2023-02-14,2023-02-14,ACTUAL,2023-02-14,,INTERVENTIONAL,,"The intent-to-treat (ITT) analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.",A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy,"An Open-Label, Long-Term Safety, Tolerability, and Efficacy Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents (Open RECLAIM-DCP)",TERMINATED,,PHASE3,44.0,ACTUAL,"Teva Branded Pharmaceutical Products R&D, Inc.",The study was terminated early due to failure of TV50717-CNS-30080 (parent study) to meet the primary efficacy endpoint.,1.0,,Failure of TV50717-CNS-30080 (parent study) to meet the primary efficacy endpoint,f,,,,t,t,f,,,,,,,,,YES,"Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.)",2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,INDUSTRY,,,,,,,2023,0.0
NCT04107675,,2019-09-25,2023-06-19,,2023-09-08,2019-09-25,2019-09-27,ACTUAL,2023-09-08,2023-10-03,ACTUAL,,,,2023-09-08,2023-10-03,ACTUAL,2020-02-11,ACTUAL,2020-02-11,2023-09,2023-09-30,2022-12-15,ACTUAL,2022-12-15,2022-06-16,ACTUAL,2022-06-16,,INTERVENTIONAL,BOSTON-4,The Safety Analysis Set (SAF) was defined as all randomized patients who had received a partial dose of IMP at least once.,A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis After Hematopoietic Transplant (BOSTON-4),"A Phase IIa Multi-Center, Randomized, Single-Blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation",TERMINATED,,PHASE2,6.0,ACTUAL,Zambon SpA,"From the beginning of the trial, only 6 patients were enrolled. Due to the low number of patients recruited so far and the slow enrolment pace of patients, on 18 March 2022, the sponsor decided to terminate the BOSTON-4 safety and tolerability trial early. This decision was made after the Sponsor performed a careful and due diligent analysis of the current study status and considered the impact of the coronavirus disease 2019 (COVID-19) pandemic on-site activities.",3.0,,"Due to the low number of patients recruited and the slow enrollment pace of patients, on 18 March 2022, the sponsor decided to terminate the BOSTON-4 safety and tolerability trial ahead of time.",f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,INDUSTRY,,,,,,,2022,0.0
NCT04739384,,2020-12-28,,,2022-07-06,2021-02-01,2021-02-04,ACTUAL,,,,,,,2022-07-06,2022-07-07,ACTUAL,2021-04-01,ACTUAL,2021-04-01,2022-07,2022-07-31,2022-06-20,ACTUAL,2022-06-20,2022-06-20,ACTUAL,2022-06-20,,INTERVENTIONAL,PlinytheElder,,Platelet Inhibition With Ticagrelor 60 mg Versus Ticagrelor 90 mg in Elderly Patients With ACS,Platelet Inhibition With Ticagrelor 60 mg Versus Ticagrelor 90 mg Twice Daily in Elderly Patients With Acute Coronary Syndrome (ACS),COMPLETED,,PHASE3,50.0,ACTUAL,Federico II University,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,OTHER,,,,,,,2022,1.0
NCT04082858,,2019-08-19,,,2021-09-01,2019-09-06,2019-09-09,ACTUAL,,,,,,,2021-09-01,2021-09-09,ACTUAL,2020-01-06,ACTUAL,2020-01-06,2021-09,2021-09-30,2020-06-03,ACTUAL,2020-06-03,2020-06-03,ACTUAL,2020-06-03,,INTERVENTIONAL,,,Ketamine Interleaved With Electroconvulsive Therapy for Depression,"Ketamine Interleaved With Electroconvulsive Therapy for Depression, A Pragmatic Randomised Controlled Pilot Trial",TERMINATED,,PHASE1,3.0,ACTUAL,"St Patrick's Hospital, Ireland",,2.0,,Inadequate recruitment due to COVID-19,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,OTHER,,,,,,,2020,0.0
NCT02865850,,2016-08-08,2022-04-25,2021-01-29,2022-07-14,2016-08-10,2016-08-15,ESTIMATED,2022-07-14,2022-07-18,ACTUAL,2021-01-29,2021-02-02,ACTUAL,2022-07-14,2022-07-18,ACTUAL,2016-07,ACTUAL,2016-07-31,2022-07,2022-07-31,2020-03-30,ACTUAL,2020-03-30,2020-01-31,ACTUAL,2020-01-31,,INTERVENTIONAL,,,Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD),"Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction or Maintenance Treatment of Anemia in Subjects With Incident Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE - CORRECTION/CONVERSION)",COMPLETED,,PHASE3,369.0,ACTUAL,Akebia Therapeutics,,2.0,,,f,,,,t,t,,,,,,,,,,NO,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,INDUSTRY,,,,,,,2020,1.0
NCT01940341,,2013-08-20,2016-12-09,2016-08-23,2023-09-22,2013-09-09,2013-09-12,ESTIMATED,2017-02-10,2017-03-30,ACTUAL,2016-08-23,2016-08-25,ESTIMATED,2023-09-22,2023-09-25,ACTUAL,2013-09-12,ACTUAL,2013-09-12,2023-09,2023-09-30,2022-08-31,ACTUAL,2022-08-31,2015-09-30,ACTUAL,2015-09-30,,INTERVENTIONAL,,Safety Analysis Set: Participants who received at least 1 dose of study drugs.,Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen,"A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Negative, Chronic Hepatitis B",COMPLETED,,PHASE3,426.0,ACTUAL,Gilead Sciences,,3.0,,,f,,,,t,,,,,,,,18 months after study completion,"A secured external environment with username, password, and RSA code.",https://www.gileadclinicaltrials.com/transparency-policy/,YES,"Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/",2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,INDUSTRY,,,,,,,2022,1.0
NCT05633745,,2022-11-21,,,2023-10-24,2022-11-21,2022-12-01,ACTUAL,,,,,,,2023-10-24,2023-10-26,ACTUAL,2023-01-30,ACTUAL,2023-01-30,2023-10,2023-10-31,2023-06-30,ACTUAL,2023-06-30,2023-06-30,ACTUAL,2023-06-30,,INTERVENTIONAL,,,A Study to Assess NEU-723 in Healthy Participants,"A Phase 1, Single and Multiple Ascending Dose Study of NEU-723 Administered Orally to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Subjects",TERMINATED,,PHASE1,40.0,ACTUAL,Neuron23 Inc.,,2.0,,Business decision,f,,,,t,f,f,,,,,,,,,,,2024-10-16 15:36:07.683357,2024-10-16 15:36:07.683357,INDUSTRY,,,,,,,2023,0.0
NCT03682601,,2018-09-14,2022-03-30,,2022-07-20,2018-09-20,2018-09-24,ACTUAL,2022-06-03,2022-06-28,ACTUAL,,,,2022-07-20,2022-07-27,ACTUAL,2018-08-30,ACTUAL,2018-08-30,2022-07,2022-07-31,2021-02-13,ACTUAL,2021-02-13,2021-02-12,ACTUAL,2021-02-12,,INTERVENTIONAL,,,Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment,"Sinecatechins Ointment, a Botanical Drug Derived From Green Tea, for the Treatment of Significant to Severe Secondary Provoked Vestibulodynia in Sexually Active, Post-Menopausal Women With Vulvovaginal Atrophy",TERMINATED,,PHASE2,32.0,ACTUAL,"GTO Pharmaceutical, LLC",Early termination due to Coronavirus disease (COVID-19) pandemic.,3.0,,pandemic,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,OTHER,,,,,,,2021,0.0
NCT03600467,,2018-06-22,,,2021-03-02,2018-07-16,2018-07-26,ACTUAL,,,,,,,2021-03-02,2021-03-05,ACTUAL,2018-08-13,ACTUAL,2018-08-13,2021-03,2021-03-31,2021-02-28,ACTUAL,2021-02-28,2021-02-28,ACTUAL,2021-02-28,,INTERVENTIONAL,START,,Activity of Seviteronel in Patients With Androgen Receptor (AR)-Positive Glioblastoma,"A Single-arm, Open-label, Signal-seeking, Phase IIa Trial of the Activity of Seviteronel in Patients With Androgen Receptor (AR)-Positive GBM",TERMINATED,,PHASE2,4.0,ACTUAL,"St Vincent's Hospital, Sydney",,1.0,,Sponsor,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,OTHER,,,,,,,2021,0.0
NCT03810105,,2019-01-17,2024-03-11,,2024-03-11,2019-01-17,2019-01-18,ACTUAL,2024-03-11,2024-04-09,ACTUAL,,,,2024-03-11,2024-04-09,ACTUAL,2019-03-07,ACTUAL,2019-03-07,2024-02,2024-02-29,2023-07-06,ACTUAL,2023-07-06,2023-07-06,ACTUAL,2023-07-06,,INTERVENTIONAL,,,A Study of Olaparib and Durvalumab in Prostate Cancer,A Phase II Study of Olaparib and Durvalumab in Men With Castration Sensitive Biochemically Recurrent Non-Metastatic Prostate Cancer Harboring Mutations in DNA Damage Repair,TERMINATED,,PHASE2,5.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,1.0,,Due to low accrual,,,,,,t,f,,,,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,OTHER,,,,,,,2023,0.0
NCT02849457,,2016-07-13,2024-04-26,,2024-07-22,2016-07-28,2016-07-29,ESTIMATED,2024-07-22,2024-08-19,ACTUAL,,,,2024-07-22,2024-08-19,ACTUAL,2016-12,,2016-12-31,2024-07,2024-07-31,2023-05-05,ACTUAL,2023-05-05,2023-04-26,ACTUAL,2023-04-26,,INTERVENTIONAL,,,Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex,"Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex (PREVeNT Trial) A Randomized, Double-blind, Placebo-controlled Seizure Prevention Clinical Trial for Infants With TSC",COMPLETED,,PHASE2,84.0,ACTUAL,University of Alabama at Birmingham,COVID-19 impacted one of the secondary endpoints (ADOS2) because of the requirement for facemasks during the assessment which would invalidate the ADOS2. Therefore this secondary outcome measure abandoned.,3.0,,,f,,,,t,,,,,,,,,,,YES,De-identified data will be shared with National Database for Autism Research (NDAR),2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,OTHER,,,,,,,2023,1.0
NCT03265574,,2017-08-24,,,2024-02-16,2017-08-25,2017-08-29,ACTUAL,,,,,,,2024-02-16,2024-02-20,ACTUAL,2017-10-04,ACTUAL,2017-10-04,2024-02,2024-02-29,2023-08-04,ACTUAL,2023-08-04,2023-08-04,ACTUAL,2023-08-04,,INTERVENTIONAL,PROACT,,PROACT: Can we Prevent Chemotherapy-related Heart Damage in Patients With Breast Cancer and Lymphoma?,"Preventing Cardiac Damage in Patients Treated for Breast Cancer and Lymphoma: a Phase 3 Randomised, Open Label, Blinded Endpoint, Superiority Trial of Enalapril to Prevent Anthracycline-induced CardioToxicity",COMPLETED,,PHASE3,111.0,ACTUAL,South Tees Hospitals NHS Foundation Trust,,2.0,,,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,OTHER,,,,,,,2023,0.0
NCT03851250,,2019-01-22,,,2024-04-16,2019-02-20,2019-02-22,ACTUAL,,,,,,,2024-04-16,2024-04-17,ACTUAL,2019-07-04,ACTUAL,2019-07-04,2024-04,2024-04-30,2023-04-26,ACTUAL,2023-04-26,2023-04-26,ACTUAL,2023-04-26,,INTERVENTIONAL,,,A Study of MRx-4DP0004 in Asthma,"A First in Human, Double-blind, Placebo-controlled, Multicentre Phase I/II Study to Evaluate the Safety, Tolerability and Immune Modulatory Effects of MRx-4DP0004 in Participants Taking Long-term Control Medication for Their Asthma",TERMINATED,,PHASE1,34.0,ACTUAL,4D pharma plc,,2.0,,Sponsor insolvency,f,,,,f,t,f,,,,,,,,,NO,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,INDUSTRY,,,,,,,2023,0.0
NCT02322593,,2014-12-12,2021-08-24,,2021-11-10,2014-12-17,2014-12-23,ESTIMATED,2021-11-10,2021-12-20,ACTUAL,,,,2021-11-10,2021-12-20,ACTUAL,2014-12,ACTUAL,2014-12-31,2021-11,2021-11-30,2020-05,ACTUAL,2020-05-31,2019-02,ACTUAL,2019-02-28,,INTERVENTIONAL,SOLAR,Full Analysis Set (FAS)：Patients in AT population who have advanced gastric cancer at randomization.,Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer,An Open-label Randomized Multi-center Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer,COMPLETED,,PHASE3,711.0,ACTUAL,"Taiho Pharmaceutical Co., Ltd.",,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,INDUSTRY,,,,,,,2020,1.0
NCT05619172,,2022-11-01,,,2024-07-26,2022-11-08,2022-11-16,ACTUAL,,,,,,,2024-07-26,2024-07-30,ACTUAL,2022-12-22,ACTUAL,2022-12-22,2024-07,2024-07-31,2024-06-05,ACTUAL,2024-06-05,2024-03-06,ACTUAL,2024-03-06,,INTERVENTIONAL,,,A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer,"A Phase 2, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of SOT101 in Combination With Cetuximab in Patients With RAS Wild-type Colorectal Cancer",TERMINATED,,PHASE2,16.0,ACTUAL,Sotio Biotech Inc.,,1.0,,Due to lack of efficacy shown at the time of the interim analysis.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,INDUSTRY,,,,,,,2024,0.0
NCT03058614,,2017-02-16,,,2022-06-01,2017-02-16,2017-02-23,ACTUAL,,,,,,,2022-06-01,2022-06-06,ACTUAL,2017-06-30,ESTIMATED,2017-06-30,2022-06,2022-06-30,2022-05-02,ACTUAL,2022-05-02,2022-05-02,ACTUAL,2022-05-02,,INTERVENTIONAL,CEUS,,Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient Management,Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient,WITHDRAWN,,PHASE2,0.0,ACTUAL,"University of California, San Francisco",,2.0,,The research team submitted grants over the course of several years to gain funds to support this research but were unsuccessful in securing the funds. The research team will now focus on other funded studies.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,OTHER,,,,,,,2022,0.0
NCT04343001,,2020-04-08,,,2020-11-17,2020-04-10,2020-04-13,ACTUAL,,,,,,,2020-11-17,2020-11-19,ACTUAL,2020-10,ESTIMATED,2020-10-31,2020-04,2020-04-30,2021-08,ESTIMATED,2021-08-31,2021-04,ESTIMATED,2021-04-30,,INTERVENTIONAL,CRASH-19,,Coronavirus Response - Active Support for Hospitalised Covid-19 Patients,"Aspirin, Losartan and Simvastatin in Hospitalised COVID-19 Patients: a Multinational Randomised Open-label Factorial Trial",WITHDRAWN,,PHASE3,0.0,ACTUAL,London School of Hygiene and Tropical Medicine,,8.0,,Grant not obtained,f,,,,t,f,f,,,,,,Within 6 months or sooner of publication,Log-in required for the sole purpose to monitor data download.,http://freebird.lshtm.ac.uk,YES,"As many sites will contribute to this trial, individual sites cannot restrict the publication of the manuscript relating to the outcomes of this trial. All anonymised data from this trial will be made freely available on our data sharing site: http://freebird.lshtm.ac.uk.",2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,OTHER,,,,,,,2021,0.0
NCT03644264,,2018-08-21,,,2021-05-31,2018-08-22,2018-08-23,ACTUAL,,,,,,,2021-05-31,2021-06-02,ACTUAL,2018-08-31,ACTUAL,2018-08-31,2021-05,2021-05-31,2020-08-21,ACTUAL,2020-08-21,2020-08-21,ACTUAL,2020-08-21,,INTERVENTIONAL,,,PA21 Safety and Efficacy in Adult Chinese Subjects,"An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 and Sevelamer Carbonate (Renvela®) in Chinese CKD Patients With Hyperphosphataemia",COMPLETED,,PHASE3,286.0,ACTUAL,Vifor Fresenius Medical Care Renal Pharma,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,INDUSTRY,,,,,,,2020,1.0
NCT05349435,,2022-04-21,,,2022-07-28,2022-04-21,2022-04-27,ACTUAL,,,,,,,2022-07-28,2022-08-01,ACTUAL,2022-05-13,ACTUAL,2022-05-13,2022-07,2022-07-31,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,,A Healthy Volunteer Study to Compare Fezagepras (PBI-4050) With Sodium Phenylbutyrate,"A Phase 1, Randomised, Open-Label, Crossover Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of PBI-4050 Compared to Sodium Phenylbutyrate in Healthy Subjects",TERMINATED,,PHASE1,8.0,ACTUAL,Liminal BioSciences Ltd.,,2.0,,Sponsor has decided to discontinue development of fezegepras based on initial pharmacokinetic results,f,,,,f,f,f,,,f,,,,,,,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,INDUSTRY,,,,,,,2022,0.0
NCT01566721,,2012-03-22,2017-03-06,,2021-04-26,2012-03-27,2012-03-29,ESTIMATED,2017-03-06,2017-04-18,ACTUAL,,,,2021-04-26,2021-04-27,ACTUAL,2012-05-17,ACTUAL,2012-05-17,2021-04,2021-04-30,2020-02-19,ACTUAL,2020-02-19,2015-03-10,ACTUAL,2015-03-10,,INTERVENTIONAL,SafeHER,Intent-to-Treat (ITT) Population: All participants enrolled into the study regardless of whether treatment was received.,A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer,"A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer",COMPLETED,,PHASE3,2577.0,ACTUAL,Hoffmann-La Roche,,2.0,,,f,,,,t,,,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,INDUSTRY,,,,,,,2020,1.0
NCT04654143,,2020-11-15,,,2023-01-16,2020-12-03,2020-12-04,ACTUAL,,,,,,,2023-01-16,2023-01-18,ACTUAL,2020-12-02,ACTUAL,2020-12-02,2022-06,2022-06-30,2023-01-16,ACTUAL,2023-01-16,2022-05-30,ACTUAL,2022-05-30,,INTERVENTIONAL,,,"Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BVL-GSK098 in Healthy Volunteers","A Phase I, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics and Food Effect of BVL-GSK098 Administered as Single and Multiple Oral Doses to Healthy Volunteers",COMPLETED,,PHASE1,80.0,ACTUAL,BioVersys AG,,3.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,INDUSTRY,,,,,,,2023,1.0
NCT02736318,,2016-04-01,,,2021-12-28,2016-04-07,2016-04-13,ESTIMATED,,,,,,,2021-12-28,2022-01-14,ACTUAL,2017-01-27,ACTUAL,2017-01-27,2021-12,2021-12-31,2021-09-07,ACTUAL,2021-09-07,2021-09-07,ACTUAL,2021-09-07,,INTERVENTIONAL,TBF3,,OD-PHOENIX in Talus Osteochondral Lesion,Treatment of Osteochondral Lesion of Talus With Processed Osteochondral Allograft,TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,TBF Genie Tissulaire,,1.0,,Low accrual rate,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,INDUSTRY,,,,,,,2021,0.0
NCT04377087,,2020-05-01,2024-05-31,,2024-07-24,2020-05-01,2020-05-06,ACTUAL,2024-07-24,2024-08-20,ACTUAL,,,,2024-07-24,2024-08-20,ACTUAL,2020-06-29,ACTUAL,2020-06-29,2024-07,2024-07-31,2023-05-31,ACTUAL,2023-05-31,2023-05-31,ACTUAL,2023-05-31,,INTERVENTIONAL,,All enrolled participants,Delayed Initiation of Olaparib Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer,Phase IIA Trial of Delayed Initiation of Olaparib Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer,TERMINATED,,PHASE2,3.0,ACTUAL,University of Pittsburgh,,1.0,,Slow enrollment,f,,,,t,t,f,,,t,,,,,,NO,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,OTHER,,,,,,,2023,0.0
NCT06102213,,2023-10-09,,,2024-08-16,2023-10-20,2023-10-26,ACTUAL,,,,,,,2024-08-16,2024-08-19,ACTUAL,2023-09-18,ACTUAL,2023-09-18,2023-10,2023-10-31,2024-08-12,ACTUAL,2024-08-12,2024-08-12,ACTUAL,2024-08-12,,INTERVENTIONAL,,,Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation,"A Randomized, Open-Label, Multicenter, Phase 2a Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)",TERMINATED,,PHASE2,46.0,ACTUAL,Prolacta Bioscience,,3.0,,Sponsor business decision to terminate the study early,f,,,,t,t,f,,,,,,To be determined,To be determined,,YES,To be determined,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,INDUSTRY,,,,,,,2024,0.0
NCT03615105,,2018-07-30,,,2024-03-08,2018-07-30,2018-08-03,ACTUAL,,,,,,,2024-03-08,2024-03-12,ACTUAL,2018-07-25,ACTUAL,2018-07-25,2024-03,2024-03-31,2024-03-06,ACTUAL,2024-03-06,2024-03-06,ACTUAL,2024-03-06,,INTERVENTIONAL,,,Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors,Allogeneic Hematopoietic Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors,TERMINATED,,PHASE2,9.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,3.0,,Low accrual,,,,,,t,f,,,,,,,,,,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,OTHER,,,,,,,2024,0.0
NCT05180422,,2021-12-06,,,2023-10-17,2021-12-17,2022-01-06,ACTUAL,,,,,,,2023-10-17,2023-10-18,ACTUAL,2022-06-15,ACTUAL,2022-06-15,2023-10,2023-10-31,2023-01-31,ACTUAL,2023-01-31,2023-01-31,ACTUAL,2023-01-31,,INTERVENTIONAL,,,"A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C Mutant NSCLC With Asymptomatic Brain Metastasis","A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C Mutant NSCLC With Asymptomatic Brain Metastasis.",WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,"Criterium, Inc.",,1.0,,Lack of enrollment,f,,,,,t,f,,,,,,,,,NO,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,INDUSTRY,,,,,,,2023,0.0
NCT03331445,,2017-10-25,,,2021-07-12,2017-10-31,2017-11-06,ACTUAL,,,,,,,2021-07-12,2021-07-16,ACTUAL,2017-10-24,ACTUAL,2017-10-24,2021-07,2021-07-31,2021-06-30,ACTUAL,2021-06-30,2021-06-30,ACTUAL,2021-06-30,,INTERVENTIONAL,,,Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections,"An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents With Non-Tuberculous Mycobacteria, Burkholderia Spp, Aspergillus Spp and Corona-like Viral (Sub-Study) Infections",TERMINATED,,PHASE2,13.0,ACTUAL,Nitric Solutions Inc.,,1.0,,Covid Incidence too low and Funding Completed,f,,,,f,f,f,,,,,,,,,NO,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,INDUSTRY,,,,,,,2021,0.0
NCT02587871,,2015-10-23,,,2018-11-07,2015-10-23,2015-10-27,ESTIMATED,,,,,,,2018-11-07,2018-11-09,ACTUAL,2018-12-12,ESTIMATED,2018-12-12,2018-11,2018-11-30,2022-11-12,ESTIMATED,2022-11-12,2020-11-12,ESTIMATED,2020-11-12,,INTERVENTIONAL,,,Donor Cellular Therapy After Cytarabine in Treating Patients With Intermediate-Risk Acute Myeloid Leukemia in Remission,HLA-Mismatched Allogeneic Cellular Therapy (Microtransplantation) After Chemotherapy in Patients With Intermediate-Risk Acute Myeloid Leukemia &lt; 60 Years,WITHDRAWN,,PHASE2,0.0,ACTUAL,University of Southern California,,1.0,,PI decided not to pursue study,f,,,,t,t,f,,,,,,,,,,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,OTHER,,,,,,,2022,0.0
NCT02362997,,2015-02-05,2022-09-26,,2023-07-24,2015-02-09,2015-02-13,ESTIMATED,2022-11-10,2022-12-08,ACTUAL,,,,2023-07-24,2023-07-27,ACTUAL,2015-04,,2015-04-30,2023-07,2023-07-31,2023-06,ACTUAL,2023-06-30,2021-10-26,ACTUAL,2021-10-26,,INTERVENTIONAL,,,"Pembrolizumab After ASCT for Hodgkin Lymphoma, DLBCL and T-NHL","A Phase 2 Study of Pembrolizumab (MK-3475) After Autologous Stem Cell Transplantation in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma and, Diffuse Large B Cell Lymphoma and T- Cell Non-Hodgkin Lymphoma",COMPLETED,,PHASE2,82.0,ACTUAL,Dana-Farber Cancer Institute,,3.0,,,f,,,,t,,,,,,,,,,,,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,OTHER,,,,,,,2023,1.0
NCT03422653,,2018-01-25,2021-09-21,2020-07-14,2022-03-29,2018-01-30,2018-02-06,ACTUAL,2022-03-29,2022-04-26,ACTUAL,2022-03-29,2022-04-26,ACTUAL,2022-03-29,2022-04-26,ACTUAL,2018-02-20,ACTUAL,2018-02-20,2022-03,2022-03-31,2020-03-26,ACTUAL,2020-03-26,2019-04-06,ACTUAL,2019-04-06,,INTERVENTIONAL,,,A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1),"A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus, With a 52-Week Open Label Extension",COMPLETED,,PHASE3,378.0,ACTUAL,"Cara Therapeutics, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,INDUSTRY,,,,,,,2020,1.0
NCT03946891,,2019-05-09,,,2022-02-09,2019-05-09,2019-05-13,ACTUAL,,,,,,,2022-02-09,2022-02-25,ACTUAL,2016-06,ACTUAL,2016-06-30,2022-02,2022-02-28,2023-06,ESTIMATED,2023-06-30,2023-06,ESTIMATED,2023-06-30,,INTERVENTIONAL,,,Nebulized Furosemide in Premature Infants With Bronchopulmonary Dysplasia - A Cross Over Pilot Study of Its Efficacy and Safety,Nebulized Furosemide in Premature Infants With Bronchopulmonary Dysplasia - A Cross Over Pilot Study of Its Efficacy and Safety,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,NYU Langone Health,,2.0,,The study was stopped due to lack of study staff and inability to enroll subjects into the study due to restrictive inclusion criteria.,f,,,,f,t,f,,,f,,,,,,,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,OTHER,,,,,,,2023,0.0
NCT03414450,,2018-01-14,,,2018-10-23,2018-01-22,2018-01-30,ACTUAL,,,,,,,2018-10-23,2018-10-25,ACTUAL,2018-04-25,ACTUAL,2018-04-25,2018-10,2018-10-31,2023-02,ESTIMATED,2023-02-28,2022-02,ESTIMATED,2022-02-28,,INTERVENTIONAL,,,Evaluation of ETC-1907206 With Dasatinib in Advanced Haematologic Malignancies,A Phase 1A Dose Escalation and Phase 1B Expansion Study to Evaluate the Safety and Tolerability of ETC-1907206 in Combination With Dasatinib in Advanced Haematologic Malignancies,WITHDRAWN,,PHASE1,0.0,ACTUAL,"EDDC (Experimental Drug Development Centre), A*STAR Research Entities",,2.0,,Withdrawal requested by D3,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-16 15:41:58.770748,2024-10-16 15:41:58.770748,OTHER_GOV,,,,,,,2023,0.0
NCT03416179,,2017-12-21,2021-06-02,,2023-04-20,2018-01-23,2018-01-31,ACTUAL,2021-06-02,2021-06-25,ACTUAL,,,,2023-04-20,2023-04-21,ACTUAL,2018-04-20,ACTUAL,2018-04-20,2023-04,2023-04-30,2022-01-17,ACTUAL,2022-01-17,2020-06-05,ACTUAL,2020-06-05,,INTERVENTIONAL,BRIGHT AML1019,Full analysis (FA) set included all randomized participants.,A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia,"A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA",COMPLETED,,PHASE3,730.0,ACTUAL,Pfizer,"In this study, inadvertently a participant was counted twice for an non-SAE Pyrexia at PCD, at SCD update this duplicity has been rectified. Due to this reason total number of participants affected by non-SAE in non-intensive placebo arm was updated to 148.",4.0,,,f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,INDUSTRY,,,,,,,2022,1.0
NCT03602781,,2018-07-06,,,2023-02-17,2018-07-25,2018-07-27,ACTUAL,,,,,,,2023-02-17,2023-02-21,ACTUAL,2018-08,ESTIMATED,2018-08-31,2018-07,2018-07-31,2020-06,ESTIMATED,2020-06-30,2019-06,ESTIMATED,2019-06-30,,INTERVENTIONAL,,,Study of PAH Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled Nitric,"Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Withdrawal Study of Pulmonary Arterial Hypertension(PAH) Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled Nitric Oxide (INO)",WITHDRAWN,,PHASE3,0.0,ACTUAL,Bellerophon,,2.0,,Decision not to proceed with Study,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,INDUSTRY,,,,,,,2020,0.0
NCT02583269,,2015-10-13,2019-05-07,,2023-06-01,2015-10-20,2015-10-22,ESTIMATED,2019-09-11,2019-09-12,ACTUAL,,,,2023-06-01,2023-06-05,ACTUAL,2016-03,ACTUAL,2016-03-31,2023-05,2023-05-31,2023-04-24,ACTUAL,2023-04-24,2017-12-19,ACTUAL,2017-12-19,,INTERVENTIONAL,,,Muscadine Grape Skin Extract in Treating Patients With Malignancy That Is Metastatic or Cannot Be Removed by Surgery,Phase I Study of Muscadine Grape Extract (MGE) in Advanced Malignancy,COMPLETED,,PHASE1,24.0,ACTUAL,Wake Forest University Health Sciences,,5.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,OTHER,,,,,,,2023,1.0
NCT03929497,,2019-04-24,,,2020-09-21,2019-04-24,2019-04-26,ACTUAL,,,,,,,2020-09-21,2020-09-23,ACTUAL,2019-04-22,ACTUAL,2019-04-22,2020-09,2020-09-30,2020-09-14,ACTUAL,2020-09-14,2020-09-01,ACTUAL,2020-09-01,,INTERVENTIONAL,,,Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms,"Interventional, Open-label, Flexible-dose, Long-term Safety Extension Study of Lu AF11167 in Patients With Schizophrenia",TERMINATED,,PHASE2,96.0,ACTUAL,H. Lundbeck A/S,,1.0,,Lack of efficacy based on the interim analysis in the 17972A study,f,,,,,f,f,,,,,,,,,,,2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,INDUSTRY,,,,,,,2020,0.0
NCT03241719,,2017-08-01,,,2021-07-22,2017-08-04,2017-08-07,ACTUAL,,,,,,,2021-07-22,2021-07-28,ACTUAL,2017-10-17,ACTUAL,2017-10-17,2021-07,2021-07-31,2021-07-21,ACTUAL,2021-07-21,2021-07-21,ACTUAL,2021-07-21,,INTERVENTIONAL,,,Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in VCA,Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in Vascularized Composite Allotransplantation,TERMINATED,,EARLY_PHASE1,2.0,ACTUAL,Brigham and Women's Hospital,,1.0,,"No participants are currently receiving therapy under this protocol, funding is coming to an end and the PI is leaving the institution.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,OTHER,,,,,,,2021,0.0
NCT04377659,,2020-05-04,2023-05-09,,2023-05-09,2020-05-04,2020-05-06,ACTUAL,2023-05-09,2023-06-05,ACTUAL,,,,2023-05-09,2023-06-05,ACTUAL,2020-05-01,ACTUAL,2020-05-01,2022-10,2022-10-31,2022-10-28,ACTUAL,2022-10-28,2022-10-28,ACTUAL,2022-10-28,,INTERVENTIONAL,,,Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection,A Phase II Study of IL-6 Receptor Antagonist Tocilizumab to Prevent Respiratory Failure and Death in Patients With Severe COVID-19 Infection,TERMINATED,,PHASE2,9.0,ACTUAL,Memorial Sloan Kettering Cancer Center,,2.0,,"Based on two large, multicenter, randomized trials showed no benefit to tocilizumab in this setting and study has been closed.",f,,,,,t,f,,,,,,,,,YES,"Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.",2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,OTHER,,,,,,,2022,0.0
NCT04739709,,2021-01-26,2023-05-18,,2023-07-13,2021-02-03,2021-02-05,ACTUAL,2023-06-14,2023-07-05,ACTUAL,,,,2023-07-13,2023-07-20,ACTUAL,2021-01-11,ACTUAL,2021-01-11,2023-07,2023-07-31,2022-03-17,ACTUAL,2022-03-17,2022-03-17,ACTUAL,2022-03-17,,INTERVENTIONAL,,Intent-to-Treat Population,Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery,"A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of APP13007 for the Treatment of Inflammation and Pain After Cataract Surgery",COMPLETED,,PHASE3,378.0,ACTUAL,"Formosa Pharmaceuticals, Inc.",,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,INDUSTRY,,,,,,,2022,1.0
NCT03499483,,2018-04-09,,,2022-04-06,2018-04-09,2018-04-17,ACTUAL,,,,,,,2022-04-06,2022-04-07,ACTUAL,2019-01-24,ACTUAL,2019-01-24,2022-04,2022-04-30,2020-03-31,ACTUAL,2020-03-31,2020-03-30,ACTUAL,2020-03-30,,INTERVENTIONAL,,,Biktarvy for Non-Occupational Post-Exposure Prophylaxis (nPEP),"A Phase IV Open-label Evaluation of Safety, Tolerability, and Acceptability of a Fixed-dose Formulation of Bictegravir, Emtricitabine/Tenofovir Alafenamide (B/F/TAF) for Non-occupational Prophylaxis Following Potential Exposure to HIV-1",COMPLETED,,PHASE4,52.0,ACTUAL,Fenway Community Health,,1.0,,,f,,,,f,t,f,,,t,,,,,,NO,,2024-10-15 05:49:46.949996,2024-10-15 05:49:46.949996,OTHER,,,,,,,2020,1.0
NCT04452669,,2020-06-29,,,2021-08-04,2020-06-29,2020-06-30,ACTUAL,,,,,,,2021-08-04,2021-08-05,ACTUAL,2020-09-15,ACTUAL,2020-09-15,2021-08,2021-08-31,2021-06-29,ACTUAL,2021-06-29,2021-06-29,ACTUAL,2021-06-29,,INTERVENTIONAL,VPCOVID,,VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation,"Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of VentaProst (Inhaled Epoprostenol Delivered Via Dedicated Delivery System) in Subjects With COVID-19 Requiring Mechanical Ventilation",COMPLETED,,PHASE2,11.0,ACTUAL,Aerogen Pharma Limited,,2.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,INDUSTRY,,,,,,,2021,1.0
NCT04058132,,2019-08-07,,,2024-02-24,2019-08-13,2019-08-15,ACTUAL,,,,,,,2024-02-24,2024-02-28,ACTUAL,2019-08-09,ACTUAL,2019-08-09,2024-02,2024-02-29,2020-03-01,ACTUAL,2020-03-01,2020-03-01,ACTUAL,2020-03-01,,INTERVENTIONAL,,,Cerebrovascular Reactivity Assessed With fNIRS as a Biomarker of TCVI After Acute Traumatic Brain Injury in Military,Cerebrovascular Reactivity (CVR) Assessed With Functional Near Infrared Spectroscopy (fNIRS) as a Biomarker of Traumatic Cerebrovascular Injury (TCVI) Measured Longitudinally After Acute TBI in Military Personnel,TERMINATED,,PHASE2,1.0,ACTUAL,Uniformed Services University of the Health Sciences,,2.0,,"funding ran out after unanticipated length of time ( for IRB approval, CRADA, and start letter",f,,,,f,t,f,,,t,,,,,,NO,none collected,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,FED,,,,,,,2020,0.0
NCT02376699,,2015-02-17,,,2023-04-27,2015-02-25,2015-03-03,ESTIMATED,,,,,,,2023-04-27,2023-05-01,ACTUAL,2015-02-28,ACTUAL,2015-02-28,2023-04,2023-04-30,2023-04-14,ACTUAL,2023-04-14,2023-03-06,ACTUAL,2023-03-06,,INTERVENTIONAL,,,Safety Study of SEA-CD40 in Cancer Patients,"A Phase 1, Open-label, Dose-escalation Study of SEA-CD40 in Adult Patients With Advanced Malignancies",TERMINATED,,PHASE1,159.0,ACTUAL,Seagen Inc.,,6.0,,Study closed due to portfolio prioritization,f,,,,f,,,,,,,,,,,,,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,INDUSTRY,,,,,,,2023,0.0
NCT04334967,,2020-04-02,,,2020-09-14,2020-04-02,2020-04-06,ACTUAL,,,,,,,2020-09-14,2020-09-16,ACTUAL,2020-03-30,ACTUAL,2020-03-30,2020-05,2020-05-31,2022-05-27,ESTIMATED,2022-05-27,2021-05-27,ESTIMATED,2021-05-27,,INTERVENTIONAL,,,Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care,Randomized Study to Evaluate the Safety and Antiviral Efficacy of Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care Treatment,SUSPENDED,,PHASE4,13.0,ACTUAL,Providence Health & Services,,2.0,,suspected unfavorable risk/benefit assessment,f,,,,f,t,f,,,f,,,,,,UNDECIDED,,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,OTHER,,,,,,,2022,0.0
NCT03524118,,2018-05-11,2023-08-29,,2023-11-10,2018-05-11,2018-05-14,ACTUAL,2023-11-10,2023-11-29,ACTUAL,,,,2023-11-10,2023-11-29,ACTUAL,2018-09-20,ACTUAL,2018-09-20,2023-11,2023-11-30,2022-09-14,ACTUAL,2022-09-14,2022-09-14,ACTUAL,2022-09-14,,INTERVENTIONAL,,,"Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)","A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1654 in Pre-Term and Full-Term Infants",COMPLETED,,PHASE1/PHASE2,183.0,ACTUAL,Merck Sharp & Dohme LLC,,8.0,,,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,INDUSTRY,,,,,,,2022,1.0
NCT05932667,,2023-06-13,,,2023-12-20,2023-06-27,2023-07-06,ACTUAL,,,,,,,2023-12-20,2023-12-21,ACTUAL,2023-10-12,ACTUAL,2023-10-12,2023-12,2023-12-31,2023-11-30,ACTUAL,2023-11-30,2023-11-24,ACTUAL,2023-11-24,,INTERVENTIONAL,DEMETER,,"Milademetan and Fulvestrant in GATA3-mutant, ER+HER- Advanced or Metastatic Breast Cancer","Milademetan and Fulvestrant in GATA3-mutant, ER-positive, HER2-negative Advanced or Metastatic Breast Cancer Patients: a Multicenter Phase II Trial",TERMINATED,,PHASE2,1.0,ACTUAL,Institut Curie,,1.0,,Financial partner providing study drug could no longer support the trial,f,,,,f,f,f,,,,,,Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.,"Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).",,YES,Investigators will share de-identified data sets documents generated under the project will be disseminated in accordance with Institut Curie policies.,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,OTHER,,,,,,,2023,0.0
NCT03639415,,2018-06-28,,,2021-03-04,2018-08-20,2018-08-21,ACTUAL,,,,,,,2021-03-04,2021-03-08,ACTUAL,2018-10-30,ESTIMATED,2018-10-30,2018-06,2018-06-30,2021-03-30,ESTIMATED,2021-03-30,2020-10-30,ESTIMATED,2020-10-30,,INTERVENTIONAL,,,Change the Dose Frequency of Controlled-Release Oxycodone to Refractory Pain,Phase II Study of Change the Dose Frequency of Controlled-Release Oxycodone to Refractory Pain,WITHDRAWN,,PHASE4,0.0,ACTUAL,Fujian Cancer Hospital,,1.0,,There is no fund to support,f,,,,,f,f,,,,,,,,,NO,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,OTHER_GOV,,,,,,,2021,0.0
NCT04800627,,2021-01-12,2022-11-29,,2022-12-22,2021-03-12,2021-03-16,ACTUAL,2022-11-29,2022-12-21,ACTUAL,,,,2022-12-22,2022-12-27,ACTUAL,2021-03-29,ACTUAL,2021-03-29,2022-12,2022-12-31,2022-11-03,ACTUAL,2022-11-03,2022-11-03,ACTUAL,2022-11-03,,INTERVENTIONAL,,,Pevonedistat and Pembrolizumab for the Treatment of dMMR/MSI-H Metastatic or Locally Advanced Unresectable Solid Tumor,A Phase I/II Trial of Pevonedistat in Combination With Pembrolizumab in Patients With dMMR/MSI-H Cancers,TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,M.D. Anderson Cancer Center,"Company stopped development of the drug and shut down the entire program with pevonedistat. Takeda had a negative phase III of the agent in liquid tumors and thus shut the program. It was not due to any toxicity, but lack of path for FDA indication.",1.0,,Per PI,,,,,f,t,f,,,,,,,,,,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,OTHER,,,,,,,2022,0.0
NCT04270877,,2020-01-30,,,2022-12-28,2020-02-12,2020-02-17,ACTUAL,,,,,,,2022-12-28,2022-12-29,ACTUAL,2021-01-06,ACTUAL,2021-01-06,2022-12,2022-12-31,2022-12-27,ACTUAL,2022-12-27,2022-12-27,ACTUAL,2022-12-27,,INTERVENTIONAL,FINAL,,Fibromyalgia and Naltrexone: The FINAL Study,Fibromyalgia and Naltrexone: The FINAL Study,COMPLETED,,PHASE2,99.0,ACTUAL,Odense University Hospital,,2.0,,,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,OTHER,,,,,,,2022,0.0
NCT04377568,,2020-04-30,,,2021-04-21,2020-05-04,2020-05-06,ACTUAL,,,,,,,2021-04-21,2021-04-23,ACTUAL,2020-10-07,ACTUAL,2020-10-07,2021-04,2021-04-30,2022-05-01,ESTIMATED,2022-05-01,2021-12-01,ESTIMATED,2021-12-01,,INTERVENTIONAL,CONCOR-KIDS,,Efficacy of Human Coronavirus-immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children,"A Randomized, Multicentered, Open-label Phase 2 Clinical Trial of the Safety and Efficacy of Human Coronavirus- Immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children",WITHDRAWN,,PHASE2,0.0,ACTUAL,The Hospital for Sick Children,,2.0,,no enrollment,f,,,,t,f,f,,,,,,,,,,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,OTHER,,,,,,,2022,0.0
NCT03238534,,2017-08-01,,,2022-11-17,2017-08-02,2017-08-03,ACTUAL,,,,,,,2022-11-17,2022-11-21,ACTUAL,2017-09-12,ACTUAL,2017-09-12,2021-12,2021-12-31,2021-09-03,ACTUAL,2021-09-03,2021-09-03,ACTUAL,2021-09-03,,INTERVENTIONAL,,,Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS,"Relief of Heartburn and Epigastric Pain Comparing Neobianacid® With Omeprazole: a Randomized, Double Blind, Double Dummy, Reference Product Controlled, Parallel Group, Non-inferiority Clinical Study",COMPLETED,,PHASE4,275.0,ACTUAL,Aboca Spa Societa' Agricola,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,INDUSTRY,,,,,,,2021,1.0
NCT03723824,,2018-10-26,,,2021-03-14,2018-10-26,2018-10-30,ACTUAL,,,,,,,2021-03-14,2021-03-16,ACTUAL,2019-02-14,ACTUAL,2019-02-14,2021-03,2021-03-31,2021-03-13,ACTUAL,2021-03-13,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,,,Grazoprevir/Elbasvir for Genotype 1b Chronic Hepatitis C After Liver or Kidney Transplantation,"An Open-label, Cohort Study of Grazoprevir/Elbasvir Combination Therapy for Patients With Genotype 1b Chronic Hepatitis C After Liver or Kidney Transplantation",TERMINATED,,PHASE4,14.0,ACTUAL,Taichung Veterans General Hospital,,1.0,,COV-19 pandemic,f,,,,f,f,f,,,,,,,,,NO,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,OTHER,,,,,,,2021,0.0
NCT03915067,,2019-03-29,2023-04-11,2021-04-12,2023-04-11,2019-04-11,2019-04-16,ACTUAL,2023-04-11,2023-05-03,ACTUAL,2021-04-12,2021-04-14,ACTUAL,2023-04-11,2023-05-03,ACTUAL,2019-04-23,ACTUAL,2019-04-23,2023-04,2023-04-30,2020-04-16,ACTUAL,2020-04-16,2020-04-16,ACTUAL,2020-04-16,,INTERVENTIONAL,,"mITT population included all randomized participants who had at least 1 post-baseline assessment of the primary efficacy parameter, the C-APPS, as described in the protocol.",BOTOX® for the Treatment of Platysma Prominence,"A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence",COMPLETED,,PHASE2,171.0,ACTUAL,Allergan,,3.0,,,f,,,,f,t,f,,,f,,,For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/,"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,INDUSTRY,,,,,,,2020,1.0
NCT04287348,,2020-02-21,,,2021-12-08,2020-02-25,2020-02-27,ACTUAL,,,,,,,2021-12-08,2021-12-29,ACTUAL,2020-07-20,ACTUAL,2020-07-20,2021-12,2021-12-31,2021-11-22,ACTUAL,2021-11-22,2021-11-22,ACTUAL,2021-11-22,,INTERVENTIONAL,ROBIN,,Intravitreal Brolucizumab in Neovascular Age-related Macular Degeneration With Limited Response to Aflibercept,Intravitreal Brolucizumab in Neovascular Age-related Macular Degeneration With Limited Response to Aflibercept,TERMINATED,,PHASE4,16.0,ACTUAL,Vista Klinik,,1.0,,due to safety letter beovu from Novartis,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,OTHER,,,,,,,2021,0.0
NCT04243278,,2020-01-09,,,2024-04-03,2020-01-24,2020-01-28,ACTUAL,,,,,,,2024-04-03,2024-04-05,ACTUAL,2020-09-14,ACTUAL,2020-09-14,2024-04,2024-04-30,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,PAPVASC,,Postpartum Low-Dose Aspirin After Preeclampsia for Optimization of Cardiovascular Risk (PAPVASC),Postpartum Low-Dose Aspirin After Preeclampsia for Optimization of Cardiovascular Risk (PAPVASC),TERMINATED,,EARLY_PHASE1,14.0,ACTUAL,Queen's University,,2.0,,Poor Recruitment Rates,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,OTHER,,,,,,,2022,0.0
NCT04061330,,2019-08-15,,,2022-04-19,2019-08-16,2019-08-19,ACTUAL,,,,,,,2022-04-19,2022-04-27,ACTUAL,2022-01-01,ESTIMATED,2022-01-01,2022-04,2022-04-30,2022-12-31,ESTIMATED,2022-12-31,2022-12-31,ESTIMATED,2022-12-31,,INTERVENTIONAL,,,Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures,Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures,WITHDRAWN,,PHASE2,0.0,ACTUAL,"The University of Texas Health Science Center, Houston",,2.0,,Study was terminated prior to enrollment due to lack of funding,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,OTHER,,,,,,,2022,0.0
NCT03704077,,2018-10-09,,,2020-05-17,2018-10-09,2018-10-12,ACTUAL,,,,,,,2020-05-17,2020-05-19,ACTUAL,2019-10-31,ESTIMATED,2019-10-31,2020-05,2020-05-31,2024-09-30,ESTIMATED,2024-09-30,2022-02-27,ESTIMATED,2022-02-27,,INTERVENTIONAL,,,"An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma","A Randomized, Active-Controlled, Open-Label, Phase 2 Clinical Trial of BMS-986213, in Combination With Various Standard-of-Care Therapeutic Regimens, in Participants With Recurrent, Locally Advanced, or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) Adenocarcinoma",WITHDRAWN,,PHASE2,0.0,ACTUAL,Bristol-Myers Squibb,,6.0,,Replaced it with another clinical trial,f,,,,f,t,f,,,,,,,,,YES,"Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html",2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,INDUSTRY,,,,,,,2024,0.0
NCT03108690,,2017-03-30,,,2023-03-27,2017-04-05,2017-04-11,ACTUAL,,,,,,,2023-03-27,2023-03-29,ACTUAL,2017-10-01,ESTIMATED,2017-10-01,2023-03,2023-03-31,2023-03-09,ACTUAL,2023-03-09,2023-03-09,ACTUAL,2023-03-09,,INTERVENTIONAL,,,Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia,Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia,WITHDRAWN,,PHASE4,0.0,ACTUAL,Hvidovre University Hospital,,2.0,,Logistics,f,,,,,f,f,,,f,,,,,,,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,OTHER,,,,,,,2023,0.0
NCT03137199,,2017-04-24,,,2020-05-20,2017-04-29,2017-05-02,ACTUAL,,,,,,,2020-05-20,2020-05-21,ACTUAL,2017-06-22,ACTUAL,2017-06-22,2020-05,2020-05-31,2020-04-29,ACTUAL,2020-04-29,2020-03-03,ACTUAL,2020-03-03,,INTERVENTIONAL,ASTEC,,Allogeneic Human Cells (hMSC) Via Intravenous Delivery in Patients With Mild Asthma,"A Phase I, Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients With Mild Asthma",TERMINATED,,PHASE1,3.0,ACTUAL,University of Miami,,2.0,,First cohort completed. Per sponsor decision.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,OTHER,,,,,,,2020,0.0
NCT03656380,,2018-08-30,2023-04-28,,2023-08-08,2018-08-30,2018-09-04,ACTUAL,2023-05-31,2023-06-23,ACTUAL,,,,2023-08-08,2023-08-23,ACTUAL,2019-03-20,ACTUAL,2019-03-20,2023-08,2023-08-31,2022-12-09,ACTUAL,2022-12-09,2022-06-06,ACTUAL,2022-06-06,,INTERVENTIONAL,,,Mepo for Eosinophilic Esophagitis (EoE) Study,"A Multi-center, Randomized, Double Blind, Parallel-arm, Placebo Controlled Trial of Mepolizumab for Treatment of Adults and Adolescents With Active Eosinophilic Esophagitis and Dysphagia-predominant Symptoms",COMPLETED,,PHASE2,66.0,ACTUAL,"University of North Carolina, Chapel Hill",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,OTHER,,,,,,,2022,1.0
NCT02814019,,2016-06-17,,2021-11-24,2021-11-24,2016-06-22,2016-06-27,ESTIMATED,,,,2021-11-24,2021-12-03,ACTUAL,2021-11-24,2021-12-03,ACTUAL,2016-09,,2016-09-30,2021-11,2021-11-30,2020-12-01,ACTUAL,2020-12-01,2020-12-01,ACTUAL,2020-12-01,,INTERVENTIONAL,SIDEROS,,A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid Steroids,"A Phase III Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Idebenone in Patients With Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids",TERMINATED,,PHASE3,255.0,ACTUAL,Santhera Pharmaceuticals,,2.0,,Interim analysis concluded to futility,f,,,,,,,,,,,,,,,,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,INDUSTRY,,,,,,,2020,0.0
NCT03894813,,2019-03-14,2021-04-05,,2021-06-17,2019-03-26,2019-03-29,ACTUAL,2021-06-17,2021-07-09,ACTUAL,,,,2021-06-17,2021-07-09,ACTUAL,2019-03-26,ACTUAL,2019-03-26,2021-06,2021-06-30,2020-12-30,ACTUAL,2020-12-30,2020-12-30,ACTUAL,2020-12-30,,INTERVENTIONAL,,,Probiotics as Adjuvant Treatment for Bacterial Vaginosis,"Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital",COMPLETED,,PHASE4,126.0,ACTUAL,Peking University Shenzhen Hospital,,2.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,OTHER,,,,,,,2020,1.0
NCT04603027,,2020-10-16,2022-07-01,,2022-11-22,2020-10-22,2020-10-26,ACTUAL,2022-11-22,2022-12-19,ACTUAL,,,,2022-11-22,2022-12-19,ACTUAL,2020-09-21,ACTUAL,2020-09-21,2022-09,2022-09-30,2021-12-06,ACTUAL,2021-12-06,2021-07-02,ACTUAL,2021-07-02,,INTERVENTIONAL,,,A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis,"A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Cohort, Dose-Ranging Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis",COMPLETED,,PHASE2,249.0,ACTUAL,"Evelo Biosciences, Inc.",,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,INDUSTRY,,,,,,,2021,1.0
NCT02873351,,2016-07-26,,,2019-04-03,2016-08-16,2016-08-19,ESTIMATED,,,,,,,2019-04-03,2019-04-05,ACTUAL,2019-09,ESTIMATED,2019-09-30,2017-05,2017-05-31,2020-12,ESTIMATED,2020-12-31,2020-12,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,A Safety and Efficacy Study of Carbidopa-levodopa in Patients With Macular Degeneration,"Pilot Study of L-DOPA Safety and Tolerability in Patients With AMD, and Proof of Concept That L-DOPA Improves Surrogate Biomarkers in Patients With Moderate to Advanced AMD",WITHDRAWN,,PHASE2,0.0,ACTUAL,"Snyder, Robert W., M.D., Ph.D., P.C.",,2.0,,Decided to do studies in patients with AMD,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,INDIV,,,,,,,2020,0.0
NCT04459338,,2020-06-30,2023-03-15,,2023-06-08,2020-07-01,2020-07-07,ACTUAL,2023-06-08,2023-06-09,ACTUAL,,,,2023-06-08,2023-06-09,ACTUAL,2021-03-04,ACTUAL,2021-03-04,2023-06,2023-06-30,2022-06-14,ACTUAL,2022-06-14,2022-06-14,ACTUAL,2022-06-14,,INTERVENTIONAL,,Subjects without diabetes to enable evaluation of insulin secretory capacity,A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion,A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion,COMPLETED,,PHASE3,11.0,ACTUAL,Mayo Clinic,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 02:23:54.748277,2024-10-17 02:23:54.748277,OTHER,,,,,,,2022,1.0
NCT04287179,,2020-02-25,,,2022-02-02,2020-02-25,2020-02-27,ACTUAL,,,,,,,2022-02-02,2022-02-03,ACTUAL,2020-03-09,ACTUAL,2020-03-09,2022-02,2022-02-28,2021-01-25,ESTIMATED,2021-01-25,2020-11-16,ESTIMATED,2020-11-16,,INTERVENTIONAL,SUSTAIN SWITCH,,SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes,Effect and Safety of Two Different Dose-escalation Regimens for Once-weekly Semaglutide s.c. in Subjects With Type 2 Diabetes Mellitus Previously Treated With GLP-1 RAs,WITHDRAWN,,PHASE3,0.0,ACTUAL,Novo Nordisk A/S,,2.0,,"COVID19 impact on this trial was evaluated and a delay of at least 6-9 months was expected. In parallel, the development of a new type of pen injector, which was an important part of the trial, was ceased and thus this trial was cancelled.",f,,,,f,t,f,,,,,,,,http://novonordisk-trials.com,YES,According to the Novo Nordisk disclosure commitment on novonordisk-trials. com,2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,INDUSTRY,,,,,,,2021,0.0
NCT04229901,,2020-01-06,,,2024-05-21,2020-01-11,2020-01-18,ACTUAL,,,,,,,2024-05-21,2024-05-22,ACTUAL,2020-01-21,ACTUAL,2020-01-21,2024-05,2024-05-31,2024-05-10,ACTUAL,2024-05-10,2024-05-10,ACTUAL,2024-05-10,,INTERVENTIONAL,DHELIVER,,Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF),"Randomized, Placebo-controlled, Double Blind, Multi-centre Phase IIb Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF",TERMINATED,,PHASE2,133.0,ACTUAL,Cellaion SA,,2.0,,Sponsor decision,f,,,,t,f,f,,,,,,,,,NO,,2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,INDUSTRY,,,,,,,2024,0.0
NCT03122106,,2017-04-17,2022-07-21,,2023-10-03,2017-04-19,2017-04-20,ACTUAL,2022-09-22,2022-10-04,ACTUAL,,,,2023-10-03,2023-10-10,ACTUAL,2018-01-05,ACTUAL,2018-01-05,2023-10,2023-10-31,2022-08-13,ACTUAL,2022-08-13,2021-09-03,ACTUAL,2021-09-03,,INTERVENTIONAL,,,Neoantigen DNA Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy,A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Neoantigen DNA Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy,TERMINATED,,PHASE1,15.0,ACTUAL,Washington University School of Medicine,,1.0,,Loss of funding,f,,,,t,t,t,,,f,,,,,,NO,,2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,OTHER,,,,,,,2022,0.0
NCT02065557,,2014-02-17,2020-09-10,,2020-09-10,2014-02-17,2014-02-19,ESTIMATED,2020-09-10,2020-10-05,ACTUAL,,,,2020-09-10,2020-10-05,ACTUAL,2014-10-13,ACTUAL,2014-10-13,2020-09,2020-09-30,2020-02-07,ACTUAL,2020-02-07,2020-02-07,ACTUAL,2020-02-07,,INTERVENTIONAL,,,Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis,"A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis",COMPLETED,,PHASE3,101.0,ACTUAL,AbbVie,,6.0,,,f,,,,t,t,f,,,f,,,"Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.",https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,INDUSTRY,,,,,,,2020,1.0
NCT01532089,,2012-02-07,2019-12-09,,2020-09-16,2012-02-09,2012-02-14,ESTIMATED,2019-12-11,2019-12-26,ACTUAL,,,,2020-09-16,2020-10-06,ACTUAL,2012-03-16,ACTUAL,2012-03-16,2020-07,2020-07-31,2020-08-18,ACTUAL,2020-08-18,2018-02-13,ACTUAL,2018-02-13,,INTERVENTIONAL,,,Erlotinib Hydrochloride With or Without Bevacizumab in Treating Patients With Stage IV Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations,A Randomized Phase II Trial of Erlotinib Alone or in Combination With Bevacizumab in Patients With Non-Small Cell Lung Cancer and Activating Epidermal Growth Factor Receptor Mutations,COMPLETED,,PHASE2,88.0,ACTUAL,Academic and Community Cancer Research United,,2.0,,,f,,,,t,t,f,,,f,,,,,,,,2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,OTHER,,,,,,,2020,1.0
NCT03006679,,2016-12-15,,,2019-01-09,2016-12-27,2016-12-30,ESTIMATED,,,,,,,2019-01-09,2019-01-11,ACTUAL,2018-08,ESTIMATED,2018-08-31,2019-01,2019-01-31,2020-12,ESTIMATED,2020-12-31,2020-06,ESTIMATED,2020-06-30,,INTERVENTIONAL,TANGOIII,,A Study of Meropenem-Vaborbactam Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia,"A Phase IIIb, Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Meropenem-Vaborbactam Versus Piperacillin/Tazobactam in the Treatment of Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia in Hospitalized Adults (TANGO III)",WITHDRAWN,,PHASE3,0.0,ACTUAL,"Melinta Therapeutics, Inc.",,4.0,,Sponsor Decision,f,,,,t,t,f,,,,,,,,,,,2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,INDUSTRY,,,,,,,2020,0.0
NCT04666298,,2020-12-07,2023-04-17,,2024-06-17,2020-12-07,2020-12-14,ACTUAL,2023-04-17,2023-05-10,ACTUAL,,,,2024-06-17,2024-06-20,ACTUAL,2021-01-29,ACTUAL,2021-01-29,2024-06,2024-06-30,2022-10-19,ACTUAL,2022-10-19,2022-04-18,ACTUAL,2022-04-18,,INTERVENTIONAL,ORION-15,,Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C,"A Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Effect of Different Doses of Inclisiran Given as Subcutaneous Injections in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C",COMPLETED,,PHASE2,312.0,ACTUAL,Novartis,,4.0,,,f,,,,t,t,f,,,t,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,INDUSTRY,,,,,,,2022,1.0
NCT02204462,,2014-07-28,,,2021-12-14,2014-07-29,2014-07-30,ESTIMATED,,,,,,,2021-12-14,2021-12-15,ACTUAL,2015-03-12,ACTUAL,2015-03-12,2021-12,2021-12-31,2021-12-13,ACTUAL,2021-12-13,2021-12-13,ACTUAL,2021-12-13,,INTERVENTIONAL,,,FBnTP Imaging of Breast Cancer,FBnTP Positron Emission Mammography Imaging of Mitochondria Function - Breast Cancer,TERMINATED,,PHASE1,4.0,ACTUAL,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,,1.0,,Lock of funding,f,,,,f,,,,,,,,,,,YES,via manuscripts publication,2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,OTHER,,,,,,,2021,0.0
NCT05417113,,2022-06-09,2024-05-02,,2024-05-02,2022-06-09,2022-06-14,ACTUAL,2024-05-02,2024-05-29,ACTUAL,,,,2024-05-02,2024-05-29,ACTUAL,2022-08-31,ACTUAL,2022-08-31,2024-05,2024-05-31,2024-02-27,ACTUAL,2024-02-27,2024-02-27,ACTUAL,2024-02-27,,INTERVENTIONAL,,,Erector Spinae Block for Spine Surgery,Evaluation of the Addition of Liposomal Bupivacaine to the Erector Spinae Plane (ESP) Block to Multilevel Lumbar Spinal Fusion Surgery,TERMINATED,,PHASE4,13.0,ACTUAL,Icahn School of Medicine at Mount Sinai,Very limited enrollment due to volume of relevant surgeries and patient eligibility. Opioid consumption confounded by nonuniform usage of PCAs post-operatively.,2.0,,recruitment difficulty,f,,,,f,t,f,,,f,,,,,,NO,IRB approval was not obtained to share IPD.,2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,OTHER,,,,,,,2024,0.0
NCT03104413,,2017-04-04,2022-03-31,2021-07-16,2022-05-19,2017-04-04,2017-04-07,ACTUAL,2022-05-19,2022-06-14,ACTUAL,2022-05-19,2022-06-14,ACTUAL,2022-05-19,2022-06-14,ACTUAL,2017-12-18,ACTUAL,2017-12-18,2021-08,2021-08-31,2021-05-19,ACTUAL,2021-05-19,2020-11-30,ACTUAL,2020-11-30,,INTERVENTIONAL,,The safety population (SA) consists of all subjects who received at least 1 dose of study medication.,A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment",COMPLETED,,PHASE3,618.0,ACTUAL,AbbVie,,6.0,,,t,,,,t,t,f,,,f,,,"For details on when studies are available for sharing, please refer to the link below.","Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.",https://vivli.org/ourmember/abbvie/,YES,"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,INDUSTRY,,NCT03914261,NO_LONGER_AVAILABLE,,,,2021,1.0
NCT02256280,,2014-09-24,,,2021-06-12,2014-10-01,2014-10-03,ESTIMATED,,,,,,,2021-06-12,2021-06-16,ACTUAL,2015-01,ACTUAL,2015-01-31,2021-06,2021-06-30,2020-03,ACTUAL,2020-03-31,2020-03,ACTUAL,2020-03-31,,INTERVENTIONAL,DATA,,A Randomized Double Blind Controlled Trial Comparing Sugammadex and Neostigmine After Thoracic Anesthesia,Decurarization After Thoracic Anesthesia - A Prospective Multicenter Double-blind Randomized Trial Comparing Sugammadex vs Neostigmine Reversal After Thoracic Anesthesia,TERMINATED,,PHASE4,70.0,ACTUAL,"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",,2.0,,Low recruiting rate due to not activation of some collaborator centers,f,,,,f,,,,,,,,,,,,,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,OTHER,,,,,,,2020,0.0
NCT03158285,,2017-05-16,2020-08-12,2020-02-24,2022-12-20,2017-05-16,2017-05-18,ACTUAL,2020-10-15,2020-11-05,ACTUAL,2020-10-15,2020-11-05,ACTUAL,2022-12-20,2022-12-22,ACTUAL,2017-07-12,ACTUAL,2017-07-12,2022-12,2022-12-31,2020-11-10,ACTUAL,2020-11-10,2019-02-25,ACTUAL,2019-02-25,,INTERVENTIONAL,,,A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis,"A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis",COMPLETED,,PHASE3,741.0,ACTUAL,"Janssen Research & Development, LLC",,3.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,INDUSTRY,,,,,,,2020,1.0
NCT04373252,,2020-04-30,,,2022-05-04,2020-04-30,2020-05-04,ACTUAL,,,,,,,2022-05-04,2022-05-06,ACTUAL,2021-07,ESTIMATED,2021-07-31,2022-05,2022-05-31,2021-07-01,ACTUAL,2021-07-01,2021-07-01,ACTUAL,2021-07-01,,INTERVENTIONAL,,,FMT as a Treatment for Severe Motility Disorder,Fecal Microbiota Transplant as a Treatment for Severe Motility Disorder,WITHDRAWN,,PHASE1,0.0,ACTUAL,"University of Colorado, Denver",,1.0,,Source of FMT preps is no longer able to provide us with necessary preps.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,OTHER,,,,,,,2021,0.0
NCT04296838,,2020-01-01,,,2022-10-24,2020-03-04,2020-03-05,ACTUAL,,,,,,,2022-10-24,2022-10-25,ACTUAL,2019-10-12,ACTUAL,2019-10-12,2022-10,2022-10-31,2022-02-12,ACTUAL,2022-02-12,2020-04-12,ACTUAL,2020-04-12,,INTERVENTIONAL,,,Effects of Conbercept in Refractory Uveitic Macular Edema and VEGF,Effectiveness of Conbercept in Treating Refractory Uveitic Macular Edema and the Changes of VEGF Levels in the Aqueous Humor,TERMINATED,,PHASE2/PHASE3,5.0,ACTUAL,Peking Union Medical College Hospital,,1.0,,"Due to inter-city travel restrictions for COVID-19, regular follow-up for most patients is not possible",f,,,,f,f,f,,,,,,,,,,,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,OTHER,,,,,,,2022,0.0
NCT04341870,,2020-04-06,,,2020-05-04,2020-04-09,2020-04-10,ACTUAL,,,,,,,2020-05-04,2020-05-06,ACTUAL,2020-04-11,ACTUAL,2020-04-11,2020-04,2020-04-30,2020-08,ESTIMATED,2020-08-31,2020-05-08,ESTIMATED,2020-05-08,,INTERVENTIONAL,CORIMUNO-VIRO,,"Study of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients: Sarilumab, Azithromycin, Hydroxychloroquine Trial - CORIMUNO-19 - VIRO","Efficacy of Sarilumab + Azithromycin + Hydroxychloroquine, and Sarilumab Alone, for Adult Patients Hospitalized With Moderate to Severe COVID-19: a Multicenter Open-label 1:1 Randomized Controlled Trial",SUSPENDED,,PHASE2/PHASE3,27.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,DSMB recommendation (futility),f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,OTHER,,,,,,,2020,0.0
NCT04195373,,2019-12-05,,,2020-11-23,2019-12-09,2019-12-11,ACTUAL,,,,,,,2020-11-23,2020-11-25,ACTUAL,2020-11-23,ACTUAL,2020-11-23,2020-11,2020-11-30,2020-11-23,ACTUAL,2020-11-23,2020-11-23,ACTUAL,2020-11-23,,INTERVENTIONAL,,,A Safety Study of TMV-018 in Patients With Tumors of the Gastrointestinal Tract,"A Phase I Open-label, Safety Study of Intra-tumoral Application of TMV-018 in Combination With 5-FC or Anti-PD-1 Therapy in Patients With Tumors of the Gastrointestinal Tract",WITHDRAWN,,PHASE1,0.0,ACTUAL,Themis Bioscience GmbH,,3.0,,"Study not started, no subjects recruited.",f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,INDUSTRY,,,,,,,2020,0.0
NCT04314713,,2020-03-10,,,2022-05-31,2020-03-17,2020-03-19,ACTUAL,,,,,,,2022-05-31,2022-06-03,ACTUAL,2020-06-02,ACTUAL,2020-06-02,2022-05,2022-05-31,2021-05-06,ACTUAL,2021-05-06,2021-04-06,ACTUAL,2021-04-06,,INTERVENTIONAL,,,A Study to Evaluate the Intramuscular Administration of Scopolamine,"A Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study To Evaluated The Safety, Tolerability, and Pharmacokinetics Of Intramuscular Administration Of Scopolamine Hydrobromide Trihydrate, Injection",TERMINATED,,PHASE1,32.0,ACTUAL,Battelle Memorial Institute,,6.0,,DSMB decision due to adverse events,,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,OTHER,,,,,,,2021,0.0
NCT02661971,,2016-01-19,,,2022-07-08,2016-01-19,2016-01-25,ESTIMATED,,,,,,,2022-07-08,2022-07-11,ACTUAL,2016-06,ACTUAL,2016-06-30,2022-07,2022-07-31,2022-06-20,ACTUAL,2022-06-20,2021-12,ACTUAL,2021-12-31,,INTERVENTIONAL,RAMSES/FLOT7,,FLOT vs. FLOT/Ramucirumab for Perioperative Therapy of Gastric or GEJ Cancer (RAMSES),Perioperative RAMucirumab in Combination With FLOT Versus FLOT Alone for reSEctable eSophagogastric Adenocarcinoma - RAMSES - a Phase II/III Trial of the AIO,COMPLETED,,PHASE2/PHASE3,180.0,ACTUAL,Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest,,2.0,,,f,,,,t,,,,,,,,,,,NO,No IPD will be shared.,2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,OTHER,,,,,,,2022,1.0
NCT01929811,,2013-08-11,,,2022-03-28,2013-08-21,2013-08-28,ESTIMATED,,,,,,,2022-03-28,2022-04-06,ACTUAL,2013-10,ACTUAL,2013-10-31,2022-03,2022-03-31,2020-06,ACTUAL,2020-06-30,2020-06,ACTUAL,2020-06-30,,INTERVENTIONAL,NeoMET,,NeoMET Study in Neoadjuvant Treatment of Breast Cancer,"Neoadjuvant Treatment of TEC Versus TEC Plus Metformin in Breast Cancer：A Prospective, Randomized Trial",TERMINATED,,PHASE2,92.0,ACTUAL,Shanghai Jiao Tong University School of Medicine,,2.0,,Slow enrollment.,f,,,,t,,,,,,,,,,,,,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,OTHER,,,,,,,2020,0.0
NCT05219370,,2021-12-30,,,2023-04-23,2022-01-20,2022-02-02,ACTUAL,,,,,,,2023-04-23,2023-04-25,ACTUAL,2022-07-31,ACTUAL,2022-07-31,2023-04,2023-04-30,2022-12-31,ACTUAL,2022-12-31,2022-12-31,ACTUAL,2022-12-31,,INTERVENTIONAL,,,"Treatment With Cannabis Oil Containing CBD, THC, CBDV or CBG vs. Placebo of Persons With ADHD","Treatment With Cannabis Oil Containing Canabidiol (CBD) Tetrahydrocannabinol (THC), Cannabidivarin (CBDV) or Cannabigerol (CBG) vs. Placebo of Persons Diagnosed With ADHD After Failure of Conventional Treatment",TERMINATED,,PHASE2,8.0,ACTUAL,Brlev Agricultural Crops Ltd,,4.0,,Difficulties in enrollment,f,,,,f,f,f,,,f,,,during all the trial,interested colleagues,,YES,Study protocol and Statistical Analysis Plan to be shared,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,INDUSTRY,,,,,,,2022,0.0
NCT04343235,,2019-10-28,2023-07-24,,2023-10-19,2020-04-10,2020-04-13,ACTUAL,2023-10-19,2023-10-23,ACTUAL,,,,2023-10-19,2023-10-23,ACTUAL,2020-05-01,ACTUAL,2020-05-01,2023-09,2023-09-30,2022-06-30,ACTUAL,2022-06-30,2022-06-30,ACTUAL,2022-06-30,,INTERVENTIONAL,,,Postpartum Management of Gestational Hypertensive Disorders Using Furosemide,Postpartum Management of Gestational Hypertensive Disorders Using Furosemide: A Randomized Controlled Trial,TERMINATED,,PHASE4,13.0,ACTUAL,Wright State University,,2.0,,Challenges with enrollment; primary investigator left the institution,f,,,,f,t,f,,,f,,,,,,NO,Data will be shared on a case by case basis,2024-10-15 05:55:08.926688,2024-10-15 05:55:08.926688,OTHER,,,,,,,2022,0.0
NCT04126278,,2019-10-11,2023-10-16,,2023-12-13,2019-10-11,2019-10-15,ACTUAL,2023-12-13,2024-01-05,ACTUAL,,,,2023-12-13,2024-01-05,ACTUAL,2020-12-01,ACTUAL,2020-12-01,2023-12,2023-12-31,2022-08-23,ACTUAL,2022-08-23,2022-08-12,ACTUAL,2022-08-12,,INTERVENTIONAL,,No patients enrolled in the Barbotage Injection arm (see participant flow).,Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection,Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection: A Randomized Controlled Double-Blind Study,TERMINATED,,PHASE4,4.0,ACTUAL,NYU Langone Health,,2.0,,Enrollment difficulty.,f,,,,t,t,f,,,t,,,Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.,"Upon reasonable request. Requests should be directed to Mehul.Shah@nyulangone.org. To gain access, data requester will need to sign a data access agreement.",,YES,"Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).",2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,OTHER,,,,,,,2022,0.0
NCT05405686,,2022-06-01,,,2024-02-26,2022-06-03,2022-06-06,ACTUAL,,,,,,,2024-02-26,2024-02-28,ACTUAL,2023-05-01,ESTIMATED,2023-05-01,2024-02,2024-02-29,2024-08-01,ESTIMATED,2024-08-01,2023-08-01,ESTIMATED,2023-08-01,,INTERVENTIONAL,,,Effect of LH Supplementation on the Endometrial Gene Expression Profile in Poor Ovarian Responders,Endometrial Gene Expression Profiles During Ovarian Stimulation With Recombinant FSH With or Without the Addition of Recombinant LH in Genuine Poor Responders,WITHDRAWN,,PHASE4,0.0,ACTUAL,CRG UZ Brussel,,2.0,,withdrawn due to practical reasons,f,,,,t,f,f,,,f,,,,,,UNDECIDED,,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,OTHER,,,,,,,2024,0.0
NCT03284307,,2017-08-22,2022-10-03,,2023-04-10,2017-09-14,2017-09-15,ACTUAL,2023-03-15,2023-04-10,ACTUAL,,,,2023-04-10,2023-04-13,ACTUAL,2017-08-10,ACTUAL,2017-08-10,2023-04,2023-04-30,2020-03-12,ACTUAL,2020-03-12,2020-03-12,ACTUAL,2020-03-12,,INTERVENTIONAL,UN-CONSCIOUS,All participants who completed a sleep and/or sedation visit.,UNderstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study,UNderstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study,COMPLETED,,PHASE4,35.0,ACTUAL,"University of Wisconsin, Madison",The fourth study drug was changed from sevoflurane to midazolam in November of 2019 due to concerns about conducting experiments in patients inhaling a volatile anesthetic through a face mask and the difficulty we would have with communicating with patients. The cessation of human subjects research due to the COVID-19 pandemic and amended institutional guidelines for conducting in-person research caused far fewer participants to be recruited than was planned.,1.0,,,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,OTHER,,,,,,,2020,1.0
NCT05618691,,2022-09-15,,,2023-09-01,2022-11-09,2022-11-16,ACTUAL,,,,,,,2023-09-01,2023-09-06,ACTUAL,2022-12-01,ESTIMATED,2022-12-01,2023-09,2023-09-30,2024-05-31,ESTIMATED,2024-05-31,2023-12-31,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,A Study of GFH312 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication (IC),"A Double-blinded, Randomized, Placebo-controlled Study of GFH312 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication (IC)",WITHDRAWN,,PHASE2,0.0,ACTUAL,Genfleet Therapeutics (Shanghai) Inc.,,4.0,,The study was terminated by sponsor for reasons of adjusted clinical development strategy.,,,,,,t,f,,,,,,,,,NO,,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,INDUSTRY,,,,,,,2024,0.0
NCT03807856,,2019-01-15,,,2022-08-30,2019-01-15,2019-01-17,ACTUAL,,,,,,,2022-08-30,2022-09-01,ACTUAL,2019-06-24,ACTUAL,2019-06-24,2022-08,2022-08-31,2020-07-23,ACTUAL,2020-07-23,2020-07-23,ACTUAL,2020-07-23,,INTERVENTIONAL,,,"Treating Acute Pancreatitis With Dabigatran, a Pilot Study","Treating Acute Pancreatitis With Dabigatran, a Pilot Study",TERMINATED,,PHASE1,2.0,ACTUAL,Mayo Clinic,,2.0,,Difficult recruitment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,OTHER,,,,,,,2020,0.0
NCT02504216,,2015-07-20,2020-11-09,,2020-12-07,2015-07-20,2015-07-21,ESTIMATED,2020-12-07,2020-12-08,ACTUAL,,,,2020-12-07,2020-12-08,ACTUAL,2015-08-18,ACTUAL,2015-08-18,2020-12,2020-12-31,2020-01-09,ACTUAL,2020-01-09,2019-11-27,ACTUAL,2019-11-27,,INTERVENTIONAL,VOYAGER PAD,,Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities,"An International, Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Thrombotic Vascular Events in Patients With Symptomatic Peripheral Artery Disease Undergoing Lower Extremity Revascularization Procedures",COMPLETED,,PHASE3,6564.0,ACTUAL,Bayer,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,INDUSTRY,,,,,,,2020,1.0
NCT04173494,,2019-11-20,2022-12-01,,2023-10-30,2019-11-20,2019-11-22,ACTUAL,2022-12-01,2022-12-22,ACTUAL,,,,2023-10-30,2023-11-01,ACTUAL,2020-02-07,ACTUAL,2020-02-07,2023-10,2023-10-31,2022-12-29,ACTUAL,2022-12-29,2021-12-03,ACTUAL,2021-12-03,,INTERVENTIONAL,,"Baseline characteristics were measured in the Intention-To-Treat (ITT) Analysis Set, which included all randomized participants.",A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM),"A Randomized, Double-blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) Versus Danazol (DAN) in Symptomatic, Anemic Subjects With Primary Myelofibrosis (PMF), Post-polycythemia Vera (PV) Myelofibrosis, or Post-essential Thrombocythemia (ET) Myelofibrosis Who Were Previously Treated With JAK Inhibitor Therapy",COMPLETED,,PHASE3,195.0,ACTUAL,Sierra Oncology LLC - a GSK company,,2.0,,,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,INDUSTRY,,,,,,,2022,1.0
NCT03945604,,2019-05-09,,,2022-08-09,2019-05-09,2019-05-10,ACTUAL,,,,,,,2022-08-09,2022-08-12,ACTUAL,2019-06-04,ACTUAL,2019-06-04,2022-08,2022-08-31,2021-02-09,ACTUAL,2021-02-09,2021-02-09,ACTUAL,2021-02-09,,INTERVENTIONAL,,,A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib and Fluzoparib in Patients With TNBC,"A Phase Ib，Open-labeled, Multi-center, Dose-exploring Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib and Fluzoparib in Subjects With Recurrent and Metastatic Triple Negative Breast Cancer",COMPLETED,,PHASE1,32.0,ACTUAL,"Jiangsu HengRui Medicine Co., Ltd.",,1.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,INDUSTRY,,,,,,,2021,1.0
NCT05269667,,2022-02-15,,,2023-11-06,2022-02-25,2022-03-08,ACTUAL,,,,,,,2023-11-06,2023-11-08,ACTUAL,2022-08-02,ACTUAL,2022-08-02,2023-11,2023-11-30,2023-10-26,ACTUAL,2023-10-26,2023-10-26,ACTUAL,2023-10-26,,INTERVENTIONAL,SAkuraBonsai,,A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention,"SAkuraBonsai: Clinical, Imaging And Biomarker Open-Label Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention",TERMINATED,,PHASE4,4.0,ACTUAL,Hoffmann-La Roche,,2.0,,Study has proved infeasible to recruit in sufficient numbers. There are insufficient eligible patients presenting to sites.,f,,,,f,t,f,,,,,,,,,YES,"Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).",2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,INDUSTRY,,,,,,,2023,0.0
NCT04674761,,2020-12-10,2023-09-08,,2023-10-10,2020-12-17,2020-12-19,ACTUAL,2023-10-10,2023-11-02,ACTUAL,,,,2023-10-10,2023-11-02,ACTUAL,2021-03-19,ACTUAL,2021-03-19,2023-10,2023-10-31,2022-09-09,ACTUAL,2022-09-09,2022-09-09,ACTUAL,2022-09-09,,INTERVENTIONAL,ASSERT,,Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome,"A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT)",COMPLETED,,PHASE3,52.0,ACTUAL,Ipsen,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,INDUSTRY,,,,,,,2022,1.0
NCT04989218,,2021-07-09,,,2024-05-07,2021-07-24,2021-08-04,ACTUAL,,,,,,,2024-05-07,2024-05-09,ACTUAL,2023-01-30,ACTUAL,2023-01-30,2024-05,2024-05-31,2024-05-01,ACTUAL,2024-05-01,2024-03-20,ACTUAL,2024-03-20,,INTERVENTIONAL,ICC,,Durvalumab and Tremelimumab With Platinum-based Chemotherapy in Intrahepatic Cholangiocarcinoma (ICC),An Open-label Window of Opportunity Trial to Evaluate the Activity of Durvalumab (MEDI4736) and Tremelimumab With Platinum-based Chemotherapy (Gemcitabine and Cisplatin) in Intrahepatic Cholangiocarcinoma (ICC),TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,University of Alabama at Birmingham,,1.0,,Slow accrual and study sponsor decision.,f,,,,t,t,f,,,,,,,,,NO,To be determined,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,OTHER,,,,,,,2024,0.0
NCT04455815,,2020-06-25,2023-01-05,,2023-12-08,2020-07-01,2020-07-02,ACTUAL,2023-12-08,2023-12-11,ACTUAL,,,,2023-12-08,2023-12-11,ACTUAL,2020-09-23,ACTUAL,2020-09-23,2023-12,2023-12-31,2022-03-03,ACTUAL,2022-03-03,2021-11-29,ACTUAL,2021-11-29,,INTERVENTIONAL,SPIKE-1,,A Trial Looking at the Use of Camostat in People Who Have Tested Positive for Coronavirus (COVID-19) (SPIKE-1),"A Randomised Phase II Trial in Early COVID-19, Assessing Use of Camostat by Blocking SARS-CoV-2 Spike Protein-initiated Membrane Fusion.",TERMINATED,,PHASE2,34.0,ACTUAL,Cancer Research UK,,2.0,,Sponsor decision,f,,,,f,f,f,,,,,,All requests made within 5 years from end-of-trial will be considered; requests made subsequently will be considered where possible.,When a request has been approved Cancer Research UK will provide access to the de-identified individual patient-level data and appropriate supporting information. A signed Data Sharing Agreement must be in place before accessing requested information. Requests should be submitted to drugdev@cancer.org.uk.,,YES,Individual de-identified patient data will be shared with researchers whose proposed use of the data is approved by a review committee of the Sponsor.,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,OTHER,,,,,,,2022,0.0
NCT03224819,,2017-07-03,2022-10-17,,2022-10-17,2017-07-19,2017-07-21,ACTUAL,2022-10-17,2023-09-01,ACTUAL,,,,2022-10-17,2023-09-01,ACTUAL,2017-09-07,ACTUAL,2017-09-07,2022-10,2022-10-31,2020-12-28,ACTUAL,2020-12-28,2020-12-28,ACTUAL,2020-12-28,,INTERVENTIONAL,,,Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML),"A Phase 1 First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 673 Administered as Short Term Intravenous Infusions in Subjects With Relapsed/Refractory Acute Myeloid Leukemia",TERMINATED,,EARLY_PHASE1,46.0,ACTUAL,Amgen,,2.0,,Priortization of other Programs,f,,,,f,t,f,,,,,,Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.,"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.",https://www.amgen.com/datasharing,YES,De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,INDUSTRY,,,,,,,2020,0.0
NCT03331640,,2017-11-01,,,2021-12-21,2017-11-01,2017-11-06,ACTUAL,,,,,,,2021-12-21,2022-01-11,ACTUAL,2018-01-02,ACTUAL,2018-01-02,2021-12,2021-12-31,2021-09-13,ACTUAL,2021-09-13,2021-09-13,ACTUAL,2021-09-13,,INTERVENTIONAL,PANTHEON,,A Health Service Research Study to Investigate Survival of Metastatic Pancreatic Cancer Patients After Sequential Chemotherapy,A Health Service Research Study to Investigate Survival of Metastatic Pancreatic Cancer Patients After Sequential Chemotherapy: An AIO Phase II Cross Over Trial (PANTHEON),TERMINATED,,PHASE2,67.0,ACTUAL,AIO-Studien-gGmbH,,2.0,,slow recruitment,f,,,,,f,f,,,,,,,,,,,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,OTHER,,,,,,,2021,0.0
NCT03926611,,2019-04-12,2022-01-22,2021-07-07,2022-04-27,2019-04-23,2019-04-24,ACTUAL,2022-01-22,2022-02-16,ACTUAL,2021-07-07,2021-07-09,ACTUAL,2022-04-27,2022-04-29,ACTUAL,2019-06-06,ACTUAL,2019-06-06,2022-04,2022-04-30,2021-04-15,ACTUAL,2021-04-15,2021-01-14,ACTUAL,2021-01-14,,INTERVENTIONAL,,"Randomized Set included all randomized subjects, regardless of whether or not they actually received study medication. Subjects were analyzed according to the treatment assigned at randomization.",This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines,"A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase 2b Dose-finding Study to Investigate the Efficacy, Safety and Tolerability of LOU064 in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines",COMPLETED,,PHASE2,311.0,ACTUAL,Novartis,,7.0,,,f,,,,t,t,f,,,,,,,,,UNDECIDED,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,INDUSTRY,,,,,,,2021,1.0
NCT03714152,,2018-10-17,,,2021-01-26,2018-10-18,2018-10-22,ACTUAL,,,,,,,2021-01-26,2021-01-27,ACTUAL,2018-11-13,ACTUAL,2018-11-13,2021-01,2021-01-31,2021-01-07,ACTUAL,2021-01-07,2020-11-23,ACTUAL,2020-11-23,,INTERVENTIONAL,,,A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B,"A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of Single and Multiple Doses of ABI-H2158 in Healthy Volunteers; and the Multiple-Ascending Dose Pharmacokinetics and Pharmacodynamics in Patients With Chronic Hepatitis B Infection",COMPLETED,,PHASE1,80.0,ACTUAL,Assembly Biosciences,,2.0,,,f,,,,f,t,f,,,t,,,,,,UNDECIDED,,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,INDUSTRY,,,,,,,2021,1.0
NCT01399372,,2011-07-20,2021-02-15,,2023-07-13,2011-07-20,2011-07-21,ESTIMATED,2021-04-20,2021-05-13,ACTUAL,,,,2023-07-13,2023-07-20,ACTUAL,2011-09,,2011-09-30,2023-05,2023-05-31,2022-05-20,ACTUAL,2022-05-20,2020-03-19,ACTUAL,2020-03-19,,INTERVENTIONAL,,Eligible participants,"Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma","Phase II Randomized Study of Rituximab, Methotrexate, Procarbazine, Vincristine, and Cytarabine With and Without Low-Dose Whole-Brain Radiotherapy for Primary Central Nervous System Lymphoma",COMPLETED,,PHASE2,91.0,ACTUAL,Radiation Therapy Oncology Group,A planned interim efficacy analysis was performed after 42 events (death or progression). The final analysis was planned to occur after 67 events. The Data Monitoring Committee (DMC) recommended releasing the interim results for early reporting and these results are considered the final study results.,2.0,,,f,,,,t,,,,,,,,,,,,,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,NETWORK,,,,,,,2022,1.0
NCT05324852,,2022-03-21,,,2024-05-23,2022-04-11,2022-04-12,ACTUAL,,,,,,,2024-05-23,2024-05-28,ACTUAL,2023-04-09,ACTUAL,2023-04-09,2024-05,2024-05-31,2024-04-23,ACTUAL,2024-04-23,2023-04-09,ACTUAL,2023-04-09,,INTERVENTIONAL,AGINASAL,,AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine,"AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine, a Randomized Non Inferiority Trial",TERMINATED,,PHASE3,1.0,ACTUAL,Assistance Publique - Hôpitaux de Paris,,2.0,,Sponsor decision:,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,OTHER,,,,,,,2024,0.0
NCT03549000,,2018-05-25,,,2023-10-16,2018-05-25,2018-06-07,ACTUAL,,,,,,,2023-10-16,2023-10-18,ACTUAL,2018-07-18,ACTUAL,2018-07-18,2023-10,2023-10-31,2022-10-17,ACTUAL,2022-10-17,2022-10-17,ACTUAL,2022-10-17,,INTERVENTIONAL,,,A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies.,"A Phase I/Ib, Open-label, Multi-center, Study of NZV930 as a Single Agent and in Combination With PDR001 and/or NIR178 in Patients With Advanced Malignancies.",TERMINATED,,PHASE1,127.0,ACTUAL,Novartis,,4.0,,After review of data which showed low likelihood of efficacy in these patients Novartis decided to terminate the trial early. Termination was not safety related,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,INDUSTRY,,,,,,,2022,0.0
NCT03237286,,2017-07-28,2023-09-12,,2024-02-23,2017-07-28,2017-08-02,ACTUAL,2023-10-06,2023-11-01,ACTUAL,,,,2024-02-23,2024-03-19,ACTUAL,2017-12-01,ACTUAL,2017-12-01,2024-02,2024-02-29,2022-10-18,ACTUAL,2022-10-18,2022-10-18,ACTUAL,2022-10-18,,INTERVENTIONAL,,,Intravenous Ketamine Plus Neurocognitive Training for Depression,"Testing a Synergistic, Neuroplasticity-Based Intervention for Depressive Neurocognition",COMPLETED,,PHASE1/PHASE2,154.0,ACTUAL,University of Pittsburgh,,3.0,,,f,,,,t,t,f,,,,,,We will comply with all NIMH guidelines regarding data repository/sharing.,,,YES,We will comply with all NIMH guidelines regarding data repository/sharing.,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,OTHER,,,,,,,2022,1.0
NCT03468140,,2018-03-09,,,2021-04-05,2018-03-09,2018-03-16,ACTUAL,,,,,,,2021-04-05,2021-04-08,ACTUAL,2021-10-01,ESTIMATED,2021-10-01,2021-04,2021-04-30,2023-12-31,ESTIMATED,2023-12-31,2023-04-30,ESTIMATED,2023-04-30,,INTERVENTIONAL,,,Pilot Trial of Eculizumab Therapy to Reduce Preservation Injury in Human Macrosteatotic Liver Transplantation,A Matched Intervention Pilot Trial of Eculizumab Therapy to Reduce Preservation Injury in Human Macrosteatotic Liver Transplantation,WITHDRAWN,,EARLY_PHASE1,0.0,ACTUAL,Yale University,,2.0,,Unable to recruit due to COVID 19,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,OTHER,,,,,,,2023,0.0
NCT03783078,,2018-12-19,2023-01-25,,2024-02-23,2018-12-19,2018-12-20,ACTUAL,2023-01-25,2023-02-17,ACTUAL,,,,2024-02-23,2024-02-28,ACTUAL,2019-02-25,ACTUAL,2019-02-25,2024-02,2024-02-29,2024-02-15,ACTUAL,2024-02-15,2022-02-15,ACTUAL,2022-02-15,,INTERVENTIONAL,,,Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913),"A Phase 3 Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) as First Line Therapy in Participants With Advanced Merkel Cell Carcinoma (KEYNOTE-913)",COMPLETED,,PHASE3,55.0,ACTUAL,Merck Sharp & Dohme LLC,,1.0,,,f,,,,f,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 06:00:29.76793,2024-10-15 06:00:29.76793,INDUSTRY,,,,,,,2024,1.0
NCT04433988,,2020-06-13,,,2023-01-16,2020-06-13,2020-06-16,ACTUAL,,,,,,,2023-01-16,2023-01-18,ACTUAL,2022-11-13,ACTUAL,2022-11-13,2023-01,2023-01-31,2022-12-30,ACTUAL,2022-12-30,2022-12-30,ACTUAL,2022-12-30,,INTERVENTIONAL,,,Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients,Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients,WITHDRAWN,,PHASE1/PHASE2,0.0,ACTUAL,Sadat City University,,2.0,,Institutional problems,f,,,,t,f,f,,,,,,,,,YES,,2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,OTHER,,,,,,,2022,0.0
NCT04380519,,2020-05-06,2022-01-10,,2022-01-21,2020-05-06,2020-05-08,ACTUAL,2022-01-21,2022-01-24,ACTUAL,,,,2022-01-21,2022-01-24,ACTUAL,2020-04-23,ACTUAL,2020-04-23,2022-01,2022-01-31,2020-07-24,ACTUAL,2020-07-24,2020-07-10,ACTUAL,2020-07-10,,INTERVENTIONAL,,,Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19),"An International, Multicenter, Randomized, Double-blind, Adaptive Placebo-controlled Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe SARS-CoV-2 Infection (COVID-19)",COMPLETED,,PHASE2/PHASE3,372.0,ACTUAL,R-Pharm,,3.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,INDUSTRY,,,,,,,2020,1.0
NCT00254384,,2005-11-14,,,2024-07-03,2005-11-14,2005-11-16,ESTIMATED,,,,,,,2024-07-03,2024-07-05,ACTUAL,2005-10-05,ACTUAL,2005-10-05,2024-07,2024-07-31,2024-05-21,ACTUAL,2024-05-21,2024-05-21,ACTUAL,2024-05-21,,INTERVENTIONAL,,,"Docetaxel, Cisplatin, and Erlotinib Hydrochloride in Treating Patients With Stage I-III Non-small Cell Lung Cancer Following Surgery","Neoadjuvant Chemotherapy With Docetaxel, Cisplatin Followed by Maintenance Therapy With the EGFR Inhibitor Erlotinib (Tarceva) in Patients With Stage I, II and III Non-Small Cell Lung Cancer Following Definitive Surgical Resection",COMPLETED,,PHASE1,50.0,ACTUAL,M.D. Anderson Cancer Center,,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,OTHER,,,,,,,2024,0.0
NCT03439839,,2018-02-14,2023-02-17,,2024-06-10,2018-02-14,2018-02-20,ACTUAL,2023-12-15,2024-01-03,ACTUAL,,,,2024-06-10,2024-06-12,ACTUAL,2018-04-09,ACTUAL,2018-04-09,2024-06,2024-06-30,2022-02-28,ACTUAL,2022-02-28,2020-04-22,ACTUAL,2020-04-22,,INTERVENTIONAL,,,"Study of Safety, Efficacy, Tolerability, Pharmacokinetics and Pharmacodynamics of LNP023 in in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","An Open Label, Single Arm, Multiple Dose Study to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of LNP023 When Administered in Addition to Standard of Care (SoC) in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) With Signs of Active Hemolysis",COMPLETED,,PHASE2,16.0,ACTUAL,Novartis,,2.0,,,f,,,,t,f,f,,,,,,,,,YES,"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,INDUSTRY,,,,,,,2022,1.0
NCT04901689,,2021-05-24,,,2022-04-08,2021-05-24,2021-05-25,ACTUAL,,,,,,,2022-04-08,2022-04-15,ACTUAL,2021-10-23,ACTUAL,2021-10-23,2021-05,2021-05-31,2023-02,ESTIMATED,2023-02-28,2023-02,ESTIMATED,2023-02-28,,INTERVENTIONAL,,,Leronlimab in Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation,"A Phase 3, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Leronlimab in Combination With Standard of Care for Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation",SUSPENDED,,PHASE3,316.0,ESTIMATED,Hospital Israelita Albert Einstein,,2.0,,Pending DSMB evaluation,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,OTHER,,,,,,,2023,0.0
NCT04216797,,2019-12-23,,,2023-04-17,2020-01-02,2020-01-03,ACTUAL,,,,,,,2023-04-17,2023-04-19,ACTUAL,2020-01-09,ACTUAL,2020-01-09,2023-02,2023-02-28,2023-02-21,ACTUAL,2023-02-21,2023-02-21,ACTUAL,2023-02-21,,INTERVENTIONAL,,,Rectal Versus Oral Diazepam Administration in the Treatment of Levator Ani Syndrome,Rectal Versus Oral Diazepam Administration in the Treatment of Levator Ani Syndrome in Participants Who Have Not Responded to Physical Therapy Treatment: A Prospective Randomized Study,WITHDRAWN,,PHASE4,0.0,ACTUAL,Swedish Medical Center,,2.0,,"Enrollment was initially suspended due to COVID pandemic. As the number of cases subsided, enrollment was reopened but never regained momentum. PI has left the site.",f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,OTHER,,,,,,,2023,0.0
NCT05700864,,2022-09-06,,,2023-01-18,2023-01-18,2023-01-26,ACTUAL,,,,,,,2023-01-18,2023-01-26,ACTUAL,2022-11-01,ESTIMATED,2022-11-01,2023-01,2023-01-31,2023-12-01,ESTIMATED,2023-12-01,2023-12-01,ESTIMATED,2023-12-01,,INTERVENTIONAL,,,NGF Treatment for Patients With Neuropathic Corneal Pain,Assessing the Efficacy of Recombinant Human Nerve Growth Factor (rhNGF) Treatment in Patients With Neuropathic Corneal Pain (NCP),WITHDRAWN,,PHASE1,0.0,ACTUAL,Tufts Medical Center,,1.0,,Funding of study was withdrawn,f,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,OTHER,,,,,,,2023,0.0
NCT04708314,,2020-09-21,,,2021-05-13,2021-01-12,2021-01-13,ACTUAL,,,,,,,2021-05-13,2021-05-17,ACTUAL,2020-10-31,ACTUAL,2020-10-31,2021-05,2021-05-31,2021-05-13,ACTUAL,2021-05-13,2021-05-13,ACTUAL,2021-05-13,,INTERVENTIONAL,,,An Open-Label Study of Golodirsen in Non-Ambulant Patients With Duchenne Muscular Dystrophy,An Open-Label Study to Evaluate the Safety of Golodirsen in Non-Ambulant Patients With Duchenne Muscular Dystrophy,TERMINATED,,PHASE4,2.0,ACTUAL,"Rare Disease Research, LLC",,1.0,,The Sponsor has decided to focus their resources on other areas of therapy.,f,,,,,t,f,,,,,,,,,,,2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,OTHER,,,,,,,2021,0.0
NCT05478031,,2022-06-09,,,2024-06-04,2022-07-26,2022-07-28,ACTUAL,,,,,,,2024-06-04,2024-06-06,ACTUAL,2022-06-07,ACTUAL,2022-06-07,2024-06,2024-06-30,2024-06-04,ACTUAL,2024-06-04,2024-06-04,ACTUAL,2024-06-04,,INTERVENTIONAL,,,A Phase 2a Study to Investigate REM0046127 in Mild to Moderate Alzheimer's Disease,"A Randomized, Placebo-controlled, Double-blind, Parallel-group Phase 2a Exploratory Study With Placebo run-in to Investigate PK/PD Effects, Safety, Tolerability and Pharmacokinetics of REM0046127 Oral Suspension Compared With Placebo in Subjects With Mild to Moderate Alzheimer's Disease",TERMINATED,,PHASE2,14.0,ACTUAL,reMYND,,3.0,,Due to the event of repeated elevated transaminase levels in one subject - elevated ALT/AST up to 6x ULN in the absence of any other potential underlying cause - we have decided to terminate the study.,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,INDUSTRY,,,,,,,2024,0.0
NCT04499352,,2020-08-03,,,2021-11-12,2020-08-03,2020-08-05,ACTUAL,,,,,,,2021-11-12,2021-11-15,ACTUAL,2020-09-14,ACTUAL,2020-09-14,2021-11,2021-11-30,2020-10-19,ACTUAL,2020-10-19,2020-10-19,ACTUAL,2020-10-19,,INTERVENTIONAL,,,A Study to Test BI 754091 Alone or in Combination With BI 836880 in People Who Have Advanced Anal Cancer,"An Open Label, Randomized Phase II Study of BI 754091 Alone or in Combination With BI 836880 in Patients With Chemotherapy Resistant, Unresectable, Metastatic Squamous Cell Carcinoma of the Anal Canal",WITHDRAWN,,PHASE2,0.0,ACTUAL,Boehringer Ingelheim,,2.0,,Not due to safety reasons (sponsor decision).,f,,,,t,t,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing",2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,INDUSTRY,,,,,,,2020,0.0
NCT01994824,,2013-11-20,,,2023-11-27,2013-11-20,2013-11-26,ESTIMATED,,,,,,,2023-11-27,2023-11-30,ACTUAL,2014-01,ACTUAL,2014-01-31,2023-11,2023-11-30,2021-09-27,ACTUAL,2021-09-27,2017-06-30,ACTUAL,2017-06-30,,INTERVENTIONAL,,,Preemptive Therapy of GVHD,Preemptive Therapy of Graft-vs-Host Disease Using Rabbit Antithymocyte Globulin,TERMINATED,,PHASE2,70.0,ACTUAL,University of Calgary,,1.0,,The trend was observed toward higher mortality among the patients receiving the intervention Thymoglobulin on day 8 after hematopoietic cell transplantation.,f,,,,f,,,,,,,,,,,,,2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,OTHER,,,,,,,2021,0.0
NCT03214666,,2017-07-07,2022-09-07,,2022-10-14,2017-07-10,2017-07-11,ACTUAL,2022-10-14,2022-11-10,ACTUAL,,,,2022-10-14,2022-11-10,ACTUAL,2020-01-01,ACTUAL,2020-01-01,2022-10,2022-10-31,2021-09-29,ACTUAL,2021-09-29,2021-08-02,ACTUAL,2021-08-02,,INTERVENTIONAL,,,GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies,"GTB-3550 (CD16/IL-15/CD33)Tri-Specific Killer Engager (TriKE®) for the Treatment of High Risk Myelodysplastic Syndromes, Refractory/Relapsed Acute Myeloid Leukemia and Advanced Systemic Mastocytosis",TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,"GT Biopharma, Inc.","This trial was terminated due to plans to clinically advance a modified second generation TriKE, requiring a new phase 1 study. Given this early termination, the maximal tolerated dose was not reached and the study did not proceed to phase 2. As only 12 participants were enrolled, the outcomes are presented in summary/descriptive format only.",2.0,,"Development of GTB-3550 halted due to development of the second generation camelid nanobody TriKE drug product, GTB-3650.",f,,,,t,t,f,,,,,,,,,,,2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,INDUSTRY,,,,,,,2021,0.0
NCT04239014,,2020-01-21,,,2021-03-09,2020-01-21,2020-01-23,ACTUAL,,,,,,,2021-03-09,2021-03-10,ACTUAL,2020-08-07,ACTUAL,2020-08-07,2021-03,2021-03-31,2021-01-25,ACTUAL,2021-01-25,2021-01-25,ACTUAL,2021-01-25,,INTERVENTIONAL,DUETTE,,"A Study to Evaluate the Effectiveness and Tolerability of a Second Maintenance Treatment in Participants With Ovarian Cancer, Who Have Previously Received Polyadenosine 5'Diphosphoribose [Poly (ADP Ribose)] Polymerase Inhibitor (PARPi) Treatment.","A Phase 2 Randomized, Multi-Centre Study to Investigate the Efficacy and Tolerability of a Second Maintenance Treatment in Patients With Platinum Sensitive Relapsed Epithelial Ovarian Cancer, Who Have Previously Received PARP Inhibitor Maintenance Treatment",WITHDRAWN,,PHASE2,0.0,ACTUAL,AstraZeneca,,3.0,,"Sponsor made the decision to terminate the DUETTE study based on the interim analysis of the VIOLETTE study (NCT03330847) investigating the combination of ceralasertib and Olaparib, where study closure was recommended due to insufficient efficacy.",,,,,t,t,f,,,f,,,"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please re-refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.","When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.",https://astrazenecagroup-dt.pharmacm.com/DT/Home,YES,"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.",2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,INDUSTRY,,,,,,,2021,0.0
NCT05961007,,2021-11-15,,,2023-07-17,2023-07-17,2023-07-27,ACTUAL,,,,,,,2023-07-17,2023-07-27,ACTUAL,2021-11-18,ACTUAL,2021-11-18,2023-07,2023-07-31,2024-04-30,ESTIMATED,2024-04-30,2023-10-31,ESTIMATED,2023-10-31,,INTERVENTIONAL,,,Evaluation of IBI302 Injection in nAMD or DME,"A Dose Escalation Study to Evaluate the Safety and Tolerability of IBI302 Intravitreal Injection in Subjects With Neovascular Age-related Macular Degeneration and Diabetic Macular Edema AND A Multi-center, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With Diabetic Macular Edema",SUSPENDED,,PHASE1/PHASE2,234.0,ESTIMATED,Innovent Biologics (Suzhou) Co. Ltd.,,2.0,,Company strategy adjustment,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,INDUSTRY,,,,,,,2024,0.0
NCT04794569,,2021-02-24,,,2024-04-02,2021-03-10,2021-03-12,ACTUAL,,,,,,,2024-04-02,2024-04-04,ACTUAL,2021-11-15,ACTUAL,2021-11-15,2023-06,2023-06-30,2024-01-19,ACTUAL,2024-01-19,2024-01-19,ACTUAL,2024-01-19,,INTERVENTIONAL,TILE,,Tinzaparin Lead-In to Prevent the Post-Thrombotic Syndrome,Tinzaparin Lead-In to Prevent the Post-Thrombotic Syndrome Phase IV Pilot Study,TERMINATED,,PHASE4,9.0,ACTUAL,Sunnybrook Health Sciences Centre,,2.0,,funding discontinued,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,OTHER,,,,,,,2024,0.0
NCT03073733,,2017-03-02,2021-11-12,,2024-06-14,2017-03-02,2017-03-08,ACTUAL,2021-12-23,2022-01-21,ACTUAL,,,,2024-06-14,2024-06-18,ACTUAL,2017-03-01,ACTUAL,2017-03-01,2024-06,2024-06-30,2020-11-13,ACTUAL,2020-11-13,2020-11-13,ACTUAL,2020-11-13,,INTERVENTIONAL,,One subject received 4M dose prior to major protocol amendment that excluded this dose group; this subject is not included in the presented analyses,Safety and Efficacy of Intravitreal Injection of Human Retinal Progenitor Cells in Adults With Retinitis Pigmentosa,"A Prospective, Multicenter, Randomized, Study of the Safety and Efficacy of Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa (RP)",COMPLETED,,PHASE2,84.0,ACTUAL,"jCyte, Inc",,3.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,INDUSTRY,,,,,,,2020,1.0
NCT03179605,,2017-05-12,2022-04-05,,2024-03-05,2017-06-05,2017-06-07,ACTUAL,2022-05-05,2022-06-01,ACTUAL,,,,2024-03-05,2024-03-07,ACTUAL,2017-05-02,ACTUAL,2017-05-02,2024-03,2024-03-31,2020-06-03,ACTUAL,2020-06-03,2019-06-03,ACTUAL,2019-06-03,,INTERVENTIONAL,,,Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06,"An Open Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06 in Pediatric Subjects With Moderate to Severe Plaque Psoriasis",TERMINATED,,PHASE2,22.0,ACTUAL,Primus Pharmaceuticals,Early termination due to low enrollment with completion of 12 to 16.9 years old group only; the planned 6 to 11.9 years of age did not enroll.,1.0,,Difficulty in enrollment,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,INDUSTRY,,,,,,,2020,0.0
NCT03181529,,2017-06-07,2021-10-15,,2021-11-19,2017-06-07,2017-06-08,ACTUAL,2021-11-19,2021-12-15,ACTUAL,,,,2021-11-19,2021-12-15,ACTUAL,2017-08-10,ACTUAL,2017-08-10,2021-11,2021-11-30,2020-12-02,ACTUAL,2020-12-02,2020-12-02,ACTUAL,2020-12-02,,INTERVENTIONAL,,,Effects of Psilocybin in Major Depressive Disorder,Effects of Psilocybin in Major Depressive Disorder,COMPLETED,,PHASE2,27.0,ACTUAL,Johns Hopkins University,,2.0,,,f,,,,t,t,f,,,,,,,,,,,2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,OTHER,,,,,,,2020,1.0
NCT02422368,,2015-04-11,,,2021-12-18,2015-04-16,2015-04-21,ESTIMATED,,,,,,,2021-12-18,2022-01-10,ACTUAL,2022-09-01,ESTIMATED,2022-09-01,2021-01,2021-01-31,2024-11,ESTIMATED,2024-11-30,2024-06,ESTIMATED,2024-06-30,,INTERVENTIONAL,,,The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease,"The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease, a Double Blind Placebo Controlled Randomized Clinical Trial",WITHDRAWN,,PHASE2/PHASE3,0.0,ACTUAL,Iran University of Medical Sciences,,2.0,,Do not access to the drug,f,,,,f,f,f,,,,,,,,,,,2024-10-15 06:06:24.865293,2024-10-15 06:06:24.865293,OTHER,,,,,,,2024,0.0
NCT02149901,,2014-05-26,,,2021-04-29,2014-05-26,2014-05-29,ESTIMATED,,,,,,,2021-04-29,2021-05-05,ACTUAL,2014-10,,2014-10-31,2021-04,2021-04-30,2020-12,ACTUAL,2020-12-31,2020-12,ACTUAL,2020-12-31,,INTERVENTIONAL,,,Water and Sudafed in Autonomic Failure,Effect of Drinking Water on the Pressor Response to Pseudoephedrine in Patients With Autonomic Failure,TERMINATED,,EARLY_PHASE1,35.0,ESTIMATED,Vanderbilt University Medical Center,,4.0,,funding terminated,f,,,,f,,,,,,,,,,,,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,OTHER,,,,,,,2020,0.0
NCT04141904,,2019-10-14,,,2022-08-08,2019-10-25,2019-10-28,ACTUAL,,,,,,,2022-08-08,2022-08-09,ACTUAL,2020-02-10,ACTUAL,2020-02-10,2022-08,2022-08-31,2022-05-23,ACTUAL,2022-05-23,2022-05-23,ACTUAL,2022-05-23,,INTERVENTIONAL,TIDE,,Tofacitinib in Depression (TIDE),"The Effects of the Anti-inflammatory Drug, Tofacitinib on Emotional and Reward Processing in Patients With Treatment-resistant Depression and Elevated High-sensitivity C-reactive Protein",TERMINATED,,PHASE1/PHASE2,2.0,ACTUAL,University of Oxford,,2.0,,Covid-19 pandemic,f,,,,f,f,f,,,t,,,,,,UNDECIDED,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,OTHER,,,,,,,2022,0.0
NCT04372940,,2020-04-29,,,2023-01-13,2020-04-29,2020-05-04,ACTUAL,,,,,,,2023-01-13,2023-01-18,ACTUAL,2023-01,ESTIMATED,2023-01-31,2023-01,2023-01-31,2024-01,ESTIMATED,2024-01-31,2024-01,ESTIMATED,2024-01-31,,INTERVENTIONAL,,,Tranexamic Acid in Gender Mastectomy,The Role of Tranexamic Acid in Aesthetic and Reconstructive Surgery,WITHDRAWN,,PHASE4,0.0,ACTUAL,"University of Wisconsin, Madison",,2.0,,due to COVID,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,OTHER,,,,,,,2024,0.0
NCT05140824,,2021-11-04,,,2024-04-11,2021-11-21,2021-12-01,ACTUAL,,,,,,,2024-04-11,2024-04-15,ACTUAL,2021-12-30,ACTUAL,2021-12-30,2024-04,2024-04-30,2022-12-14,ACTUAL,2022-12-14,2022-12-14,ACTUAL,2022-12-14,,INTERVENTIONAL,,,"A Study to Evaluate the Safety, Tolerability, and PK Profile of Single and Multiple Doses TJ202 in Patient With Systemic Lupus Erythematosus","A Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of TJ202 in Patients With Systemic Lupus Erythematosus",TERMINATED,,PHASE1,1.0,ACTUAL,"TJ Biopharma Co., Ltd.",,2.0,,Company development strategy adjustment,f,,,,f,f,f,,,,,,,,,,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,INDUSTRY,,,,,,,2022,0.0
NCT02840799,,2016-06-13,2023-07-27,,2023-12-14,2016-07-18,2016-07-21,ESTIMATED,2023-12-14,2023-12-18,ACTUAL,,,,2023-12-14,2023-12-18,ACTUAL,2016-08,,2016-08-31,2023-12,2023-12-31,2022-08,ACTUAL,2022-08-31,2022-08,ACTUAL,2022-08-31,,INTERVENTIONAL,,,Effect of KNO3 Compared to KCl on Oxygen UpTake in Heart Failure With Preserved Ejection Fraction (KNO3CK OUT HFPEF),Effect of KNO3 Compared to KCl on Oxygen UpTake in Heart Failure With Preserved Ejection Fraction (KNO3CK OUT HFPEF),COMPLETED,,PHASE2,84.0,ACTUAL,University of Pennsylvania,"Due to dispensing errors, nine participants didn't crossover. Overall study power was maintained. MRI completion varied across sites, leading to the discontinuation of this study component. MRI endpoints have a smaller N; interpret results cautiously. Myocardial circumferential strain wasn't quantified. Instead, longitudinal LV function, crucial for LV relaxation and filling, was quantified.",2.0,,,f,,,,t,,,,,,,,,,,NO,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,OTHER,,,,,,,2022,1.0
NCT04990804,,2021-07-29,2023-10-10,,2024-01-06,2021-07-29,2021-08-05,ACTUAL,2024-01-06,2024-01-31,ACTUAL,,,,2024-01-06,2024-01-31,ACTUAL,2021-08-01,ACTUAL,2021-08-01,2024-01,2024-01-31,2022-02-01,ACTUAL,2022-02-01,2022-02-01,ACTUAL,2022-02-01,,INTERVENTIONAL,,,Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery,Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery,TERMINATED,,PHASE4,8.0,ACTUAL,Vanderbilt University Medical Center,,2.0,,Limitations of the prospective study design revealed that a retrospective study design would be better suited.,f,,,,,t,f,,,f,,,,,,NO,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,OTHER,,,,,,,2022,0.0
NCT04497038,,2020-06-29,2024-04-16,,2024-07-10,2020-07-31,2020-08-04,ACTUAL,2024-07-10,2024-08-06,ACTUAL,,,,2024-07-10,2024-08-06,ACTUAL,2021-08-06,ACTUAL,2021-08-06,2024-07,2024-07-31,2023-05-02,ACTUAL,2023-05-02,2023-05-02,ACTUAL,2023-05-02,,INTERVENTIONAL,,,Cabozantinib in Patients With Advanced Hepatocellular Carcinoma With Child Pugh Class B Cirrhosis After First-Line Therapy,Phase 1/2 Trial to Evaluate Cabozantinib in Patients With Advanced Hepatocellular Carcinoma With Child Pugh Class B Cirrhosis After First-Line Therapy,TERMINATED,,PHASE1/PHASE2,3.0,ACTUAL,University of Michigan Rogel Cancer Center,,1.0,,loss of funding,f,,,,,t,f,,,t,,,,,,NO,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,OTHER,,,,,,,2023,0.0
NCT04556383,,2020-09-15,2023-05-31,,2023-07-27,2020-09-15,2020-09-21,ACTUAL,2023-07-27,2023-08-01,ACTUAL,,,,2023-07-27,2023-08-01,ACTUAL,2020-10-19,ACTUAL,2020-10-19,2023-07,2023-07-31,2022-06-01,ACTUAL,2022-06-01,2022-06-01,ACTUAL,2022-06-01,,INTERVENTIONAL,,,A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC),"A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate GB004 in Adult Subjects With Mild-to-moderate Active Ulcerative Colitis",TERMINATED,,PHASE2,236.0,ACTUAL,Gossamer Bio Inc.,,4.0,,Study terminated due to lack of treatment benefit.,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,INDUSTRY,,,,,,,2022,0.0
NCT04093024,,2019-09-16,2022-11-22,,2024-06-25,2019-09-16,2019-09-17,ACTUAL,2023-01-11,2023-01-31,ACTUAL,,,,2024-06-25,2024-07-09,ACTUAL,2019-12-03,ACTUAL,2019-12-03,2024-06,2024-06-30,2022-05-24,ACTUAL,2022-05-24,2022-05-24,ACTUAL,2022-05-24,,INTERVENTIONAL,InPedILD®,Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.,A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD),"A Double Blind, Randomised, Placebo-controlled Trial to Evaluate the Dose-exposure and Safety of Nintedanib Per os on Top of Standard of Care for 24 Weeks, Followed by Open Label Treatment With Nintedanib of Variable Duration, in Children and Adolescents (6 to 17 Year-old) With Clinically Significant Fibrosing Interstitial Lung Disease",COMPLETED,,PHASE3,39.0,ACTUAL,Boehringer Ingelheim,"In the protocol it was planned to communicate the end of trial (EoT) once 30 participants had completed pharmacokinetic (PK) sampling at Week 26 or prematurely discontinued the trial and PK data was confirmed as adequate.~When the EoT was communicated, no participant had reached Week 100 yet, thus Week 100 time points were not assessable and the trial was completed as per protocol.",2.0,,,f,,,,t,t,f,,,,,,,,,NO,"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datatransparency",2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,INDUSTRY,,,,,,,2022,1.0
NCT03052400,,2017-02-08,2022-09-22,,2023-04-24,2017-02-13,2017-02-14,ACTUAL,2022-09-22,2022-10-19,ACTUAL,,,,2023-04-24,2023-05-18,ACTUAL,2017-02-03,ACTUAL,2017-02-03,2023-04,2023-04-30,2021-05-31,ACTUAL,2021-05-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,,,Efficacy of Mifepristone in Males With Type 2 Diabetes Mellitus,Efficacy of Mifepristone in Males With Type 2 Diabetes Mellitus,TERMINATED,,PHASE2,8.0,ACTUAL,Charles Drew University of Medicine and Science,"Administrative barriers and pandemic closures limited enrollment, curtailed several secondary outcome measures, and caused early termination of the study.",2.0,,End of Funding,f,,,,t,t,f,,,,,,After publication,Contact investigator,,YES,Data sharing as per NIH funding requirements,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,OTHER,,,,,,,2021,0.0
NCT02177071,,2014-06-26,,,2022-08-02,2014-06-26,2014-06-27,ESTIMATED,,,,,,,2022-08-02,2022-08-03,ACTUAL,2015-10-09,ACTUAL,2015-10-09,2022-08,2022-08-31,2021-10,ACTUAL,2021-10-31,2021-06,ACTUAL,2021-06-30,,INTERVENTIONAL,SPARE,,A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy,A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy,COMPLETED,,PHASE4,211.0,ACTUAL,Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives,,3.0,,,f,,,,t,f,f,,,,,,,,,,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,OTHER,,,,,,,2021,1.0
NCT04543279,,2020-09-08,2023-11-22,2023-03-23,2023-12-14,2020-09-08,2020-09-10,ACTUAL,2023-12-14,2023-12-15,ACTUAL,,2023-12-15,ACTUAL,2023-12-14,2023-12-15,ACTUAL,2021-05-03,ACTUAL,2021-05-03,2023-12,2023-12-31,2022-07-30,ACTUAL,2022-07-30,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,,None of the participants in Part A received treatment on Part B.,Fostamatinib as a Single Agent or in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis With Severe Thrombocytopenia,Fostamatinib as a Single Agent or in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis With Severe Thrombocytopenia,TERMINATED,,PHASE2,3.0,ACTUAL,Washington University School of Medicine,,2.0,,Low accrual,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,OTHER,,,,,,,2022,0.0
NCT04326283,,2020-03-24,,,2023-05-07,2020-03-27,2020-03-30,ACTUAL,,,,,,,2023-05-07,2023-05-09,ACTUAL,2020-04-02,ACTUAL,2020-04-02,2023-05,2023-05-31,2023-04-28,ACTUAL,2023-04-28,2023-04-28,ACTUAL,2023-04-28,,INTERVENTIONAL,,,"Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS)","A Sequential Dose-Escalation, Randomized, Active-Controlled, Multi-Center, Phase 1/2a Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of SNR1611 in Patients With Amyotrophic Lateral Sclerosis",TERMINATED,,PHASE1/PHASE2,23.0,ACTUAL,Genuv Inc.,,3.0,,Terminated as it is considered that necessary data have been collected,f,,,,t,f,f,,,f,,,,,,NO,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,INDUSTRY,,,,,,,2023,0.0
NCT04621149,,2020-11-05,,,2022-09-27,2020-11-06,2020-11-09,ACTUAL,,,,,,,2022-09-27,2022-09-30,ACTUAL,2020-11-15,ACTUAL,2020-11-15,2022-09,2022-09-30,2022-03-31,ACTUAL,2022-03-31,2022-03-31,ACTUAL,2022-03-31,,INTERVENTIONAL,PROFACT-01,,An Outpatient Study Investigating Non-prescription Treatments for COVID-19,"A Phase 2 Screening Study of Candidate Non-prescription Treatments for COVID-19: A Patient-driven, Randomized, Factorial Study Evaluating Patient-reported Outcomes (PROFACT-01)",TERMINATED,,PHASE2,10.0,ACTUAL,"Profact, Inc.",,8.0,,Unable to recruit participants due to decline in COVID-19.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,OTHER,,,,,,,2022,0.0
NCT05083117,,2021-10-17,,,2023-08-17,2021-10-17,2021-10-19,ACTUAL,,,,,,,2023-08-17,2023-08-21,ACTUAL,2021-10-30,ESTIMATED,2021-10-30,2023-08,2023-08-31,2022-04-10,ESTIMATED,2022-04-10,2022-03-10,ESTIMATED,2022-03-10,,INTERVENTIONAL,,,Safety and Efficacy of Inhaled XW001 For Hospitalized COVID-19 Patients Requiring Oxygen Therapy,"Safety and Efficacy of Inhaled XW001 (Interleukin 29 Analog for Nebulization) For Hospitalized COVID-19 Patients Requiring Oxygen Therapy: A Multiregional, Randomized, Double-blind, Placebo-controlled Study",WITHDRAWN,,PHASE2,0.0,ACTUAL,Sciwind Biosciences APAC CO Pty. Ltd.,,2.0,,Difficulty in COVID-19 subject enrollment,f,,,,t,f,f,,,,,,,,,NO,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,INDUSTRY,,,,,,,2022,0.0
NCT04374942,,2020-04-30,,,2021-04-27,2020-04-30,2020-05-05,ACTUAL,,,,,,,2021-04-27,2021-04-29,ACTUAL,2020-04-30,ACTUAL,2020-04-30,2021-04,2021-04-30,2021-03-31,ACTUAL,2021-03-31,2021-03-31,ACTUAL,2021-03-31,,INTERVENTIONAL,HEROs,,Does Hydroxychloroquine Before & During Patient Exposure Protect Healthcare Workers From Coronavirus?,"Protecting Frontline Health Care Workers From COVID-19 With Hydroxychloroquine Pre-exposure Prophylaxis: A Randomized, Placebo-controlled Multi-Site Trial in Toronto, Canada",TERMINATED,,PHASE3,13.0,ACTUAL,"University Health Network, Toronto",,2.0,,"Due to unproven issues associated with hydroxychloroquine use and safety, further complicated by media and political misinformation which in effect rendered all global studies on HCQ to stop enrolling participants.",f,,,,t,f,f,,,f,,,,,,YES,"At the time of completion of the analysis of primary and secondary outcomes, the HEROS Steering Committee will review all applications for use of participant level data and make recommendations.",2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,OTHER,,,,,,,2021,0.0
NCT04155580,,2019-11-05,,,2024-08-01,2019-11-05,2019-11-07,ACTUAL,,,,,,,2024-08-01,2024-08-02,ACTUAL,2020-06-12,ACTUAL,2020-06-12,2024-08,2024-08-31,2022-01-14,ACTUAL,2022-01-14,2022-01-14,ACTUAL,2022-01-14,,INTERVENTIONAL,,,A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML),"A Phase 1, Parallel, Open-Label Study of the Safety and Tolerability, Pharmacokinetics, and Antileukemic Activity of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)",TERMINATED,,PHASE1,68.0,ACTUAL,"Astex Pharmaceuticals, Inc.",,3.0,,Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention,f,,,,,t,f,,,,,,,,,NO,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,INDUSTRY,,,,,,,2022,0.0
NCT02100696,,2014-03-27,2021-04-09,,2021-07-22,2014-03-27,2014-04-01,ESTIMATED,2021-05-20,2021-06-15,ACTUAL,,,,2021-07-22,2021-08-13,ACTUAL,2014-05-21,ACTUAL,2014-05-21,2021-07,2021-07-31,2020-04-16,ACTUAL,2020-04-16,2020-04-16,ACTUAL,2020-04-16,,INTERVENTIONAL,HICKORY,A total of 609 participants were enrolled into the Induction phase of this study and the entire study. A subset (259) of these participants moved into the Maintenance phase of this study.,A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors,"Phase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors",COMPLETED,,PHASE3,609.0,ACTUAL,Hoffmann-La Roche,,6.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,INDUSTRY,,,,,,,2020,1.0
NCT05429385,,2022-04-29,,,2022-06-20,2022-06-20,2022-06-23,ACTUAL,,,,,,,2022-06-20,2022-06-23,ACTUAL,2020-12-09,ESTIMATED,2020-12-09,2022-06,2022-06-30,2021-09-18,ESTIMATED,2021-09-18,2021-09-06,ESTIMATED,2021-09-06,,INTERVENTIONAL,,,Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers,"A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Phase I Clinical Study to Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers",WITHDRAWN,,PHASE1,0.0,ACTUAL,Shanghai Henlius Biotech,,3.0,,Sponsor strategy.,,,,,,t,f,,,,,,,,,NO,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,INDUSTRY,,,,,,,2021,0.0
NCT01765218,,2013-01-07,2023-12-19,,2024-05-15,2013-01-08,2013-01-10,ESTIMATED,2024-05-15,2024-06-11,ACTUAL,,,,2024-05-15,2024-06-11,ACTUAL,2013-02,ACTUAL,2013-02-28,2024-05,2024-05-31,2022-01-27,ACTUAL,2022-01-27,2022-01-27,ACTUAL,2022-01-27,,INTERVENTIONAL,,,Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy,Topiramate as an Adjuvant to Therapeutic Hypothermia for Infants With Hypoxic Ischemic Encephalopathy,TERMINATED,,PHASE1/PHASE2,34.0,ACTUAL,"University of California, Davis",Study was stopped short of intended recruitment due to difficulty with recruitment during COVID pandemic and changes to the therapeutic hypothermia protocol at our institution.,2.0,,The study was stopped early due to changes in the UC Davis guidelines on who qualified for therapeutic hypothermia and significant difficulty in recruitment of patients following the COVID19 pandemic.,f,,,,t,,,,,,,,,,,,,2024-10-15 06:12:11.075132,2024-10-15 06:12:11.075132,OTHER,,,,,,,2022,0.0
NCT02282241,,2014-10-30,,,2021-09-29,2014-11-03,2014-11-04,ESTIMATED,,,,,,,2021-09-29,2021-10-07,ACTUAL,2016-02,,2016-02-29,2021-09,2021-09-30,2021-09,ESTIMATED,2021-09-30,2021-09,ESTIMATED,2021-09-30,,INTERVENTIONAL,,,Melatonin for Delirium Prophylaxis,A Randomized Double-Blind Placebo-Controlled Study on the Use of Melatonin for the Prevention of Delirium,WITHDRAWN,,PHASE4,0.0,ACTUAL,University of British Columbia,,2.0,,Project never began,f,,,,t,,,,,,,,,,,,,2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,OTHER,,,,,,,2021,0.0
NCT03550352,,2018-05-23,,,2022-06-26,2018-06-06,2018-06-08,ACTUAL,,,,,,,2022-06-26,2022-06-30,ACTUAL,2021-08-20,ACTUAL,2021-08-20,2022-06,2022-06-30,2022-05-31,ACTUAL,2022-05-31,2022-05-31,ACTUAL,2022-05-31,,INTERVENTIONAL,,,Cannabinoids in PLWHIV on Effective ART,"Cannabinoids in People Living With HIV on Effective Antiretroviral Therapy: A Pilot Study to Assess Safety, Tolerability and Effect on Immune Activation",TERMINATED,,PHASE2,10.0,ACTUAL,McGill University Health Centre/Research Institute of the McGill University Health Centre,,2.0,,expiration of study product; end of study product availability,f,,,,t,f,f,,,,,,,,,UNDECIDED,,2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,OTHER,,,,,,,2022,0.0
NCT03374852,,2017-12-04,,,2018-08-20,2017-12-11,2017-12-15,ACTUAL,,,,,,,2018-08-20,2018-08-22,ACTUAL,2018-08,ESTIMATED,2018-08-31,2018-08,2018-08-31,2020-10,ESTIMATED,2020-10-31,2019-10-05,ESTIMATED,2019-10-05,,INTERVENTIONAL,,,CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer,A Phase II Open-Label Clinical Trial of CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer and Good Performance Status,WITHDRAWN,,PHASE2,0.0,ACTUAL,Thomas Jefferson University,,1.0,,PI Left institution on 8/6/2018 and study has been final reported with IRB. Never opened to accrual,,,,,t,t,f,,,,,,,,,,,2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,OTHER,,,,,,,2020,0.0
NCT04435717,,2020-06-11,,,2021-08-24,2020-06-16,2020-06-17,ACTUAL,,,,,,,2021-08-24,2021-08-30,ACTUAL,2020-05-04,ACTUAL,2020-05-04,2021-08,2021-08-31,2021-02-10,ACTUAL,2021-02-10,2020-11-04,ACTUAL,2020-11-04,,INTERVENTIONAL,COVITOZ-01,,Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (COVITOZ-01),"Unicenter, Randomized, Open-label Clinical Trial on the Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19",TERMINATED,,PHASE2,26.0,ACTUAL,Hospital Universitario Ramon y Cajal,,3.0,,Futility,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,OTHER,,,,,,,2021,0.0
NCT04530136,,2020-08-26,2023-02-22,,2024-02-15,2020-08-26,2020-08-28,ACTUAL,2024-02-15,2024-02-16,ACTUAL,,,,2024-02-15,2024-02-16,ACTUAL,2020-11-30,ACTUAL,2020-11-30,2024-02,2024-02-29,2021-12-01,ACTUAL,2021-12-01,2021-09-07,ACTUAL,2021-09-07,,INTERVENTIONAL,,"Analyzed (FAS/ITT - Interim analysis/Overrunning analysis) in interim analysis phase: rhC1INH plus SOC \[n=23\]; SOC alone \[n=9\]. A subsequent (post hoc) analysis was conducted to include all 38 patients, overrunning analysis phase: rhC1INH plus SOC \[n=27\]; SOC alone \[n=11\].",Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19,"Recombinant Human C1 Esterase Inhibitor (Ruconest®) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group, Open-label, Multi-center Pilot Trial in the US",COMPLETED,,PHASE2,38.0,ACTUAL,Pharming Technologies B.V.,,2.0,,,,,,,,t,f,,,,,,,,,NO,,2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,INDUSTRY,,,,,,,2021,1.0
NCT04994002,,2021-07-20,,,2022-03-07,2021-07-29,2021-08-06,ACTUAL,,,,,,,2022-03-07,2022-03-22,ACTUAL,2021-09-03,ACTUAL,2021-09-03,2022-03,2022-03-31,2022-06,ESTIMATED,2022-06-30,2022-06,ESTIMATED,2022-06-30,,INTERVENTIONAL,,,"A Pharmacokinetic, Pharmacodynamic, Safety and Tolerability Study of CERC-006 in Adults With Complex Lymphatic Malformations","A Phase 1b, Open-Label, Pharmacokinetic, Pharmacodynamic, Safety and Tolerability Study of CERC-006 in Adults (Aged 18-31 Years) With Complex Lymphatic Malformations",WITHDRAWN,,PHASE1,0.0,ACTUAL,"Avalo Therapeutics, Inc.",,2.0,,Sponsor Decision,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,INDUSTRY,,,,,,,2022,0.0
NCT02152956,,2014-05-28,2023-05-05,,2024-01-24,2014-05-28,2014-06-02,ESTIMATED,2024-01-24,2024-01-30,ACTUAL,,,,2024-01-24,2024-01-30,ACTUAL,2014-06-09,ACTUAL,2014-06-09,2024-01,2024-01-31,2022-07-05,ACTUAL,2022-07-05,2022-07-05,ACTUAL,2022-07-05,,INTERVENTIONAL,VOYAGE,,Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML),"A Phase 1/2, First in Human, Dose Escalation Study of MGD006, a CD123 x CD3 DART® Bi-Specific Antibody Based Molecule, in Patients With Relapsed or Refractory AML or Intermediate-2/High Risk Myelodysplastic Syndrome (MDS)",TERMINATED,,PHASE1/PHASE2,244.0,ACTUAL,MacroGenics,,13.0,,Business decision,t,,,,t,t,f,,,,,,,,,,,2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,INDUSTRY,,NCT04678466,NO_LONGER_AVAILABLE,,,,2022,0.0
NCT04338061,,2020-04-06,,,2024-04-25,2020-04-06,2020-04-08,ACTUAL,,,,,,,2024-04-25,2024-04-29,ACTUAL,2020-07-02,ACTUAL,2020-07-02,2024-04,2024-04-30,2024-03-19,ACTUAL,2024-03-19,2023-10-02,ACTUAL,2023-10-02,,INTERVENTIONAL,,,Study of Evobrutinib in Participants With RMS (evolutionRMS 2),"A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 2)",TERMINATED,,PHASE3,1124.0,ACTUAL,"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany",,2.0,,Results from the EVOLUTION clinical trials showed evobrutinib did not meet its primary endpoint of annualized relapse rate for up to 156 weeks compared to oral teriflunomide in both studies.,f,,,,,t,f,,,,,,Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union,Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.,http://bit.ly/IPD21,YES,"We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21",2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,INDUSTRY,,,,,,,2024,0.0
NCT03803241,,2016-11-18,,,2021-09-22,2019-01-11,2019-01-14,ACTUAL,,,,,,,2021-09-22,2021-09-27,ACTUAL,2019-05-31,ACTUAL,2019-05-31,2021-09,2021-09-30,2021-06-30,ACTUAL,2021-06-30,2020-12-31,ACTUAL,2020-12-31,,INTERVENTIONAL,cellcol,,Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases.,Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases That Are Going to be Submitted to a Major Liver Resection,COMPLETED,,PHASE2,4.0,ACTUAL,"Hospital San Carlos, Madrid",,2.0,,,f,,,,f,f,f,,,,,,,,,,,2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,OTHER,,,,,,,2021,1.0
NCT04335136,,2020-04-01,2021-06-07,,2021-07-29,2020-04-03,2020-04-06,ACTUAL,2021-07-29,2021-08-02,ACTUAL,,,,2021-07-29,2021-08-02,ACTUAL,2020-04-30,ACTUAL,2020-04-30,2021-07,2021-07-31,2020-12-26,ACTUAL,2020-12-26,2020-12-26,ACTUAL,2020-12-26,,INTERVENTIONAL,APN01-COVID-19,All randomized patients who received at least 1 dose of investigational medicinal product (IMP).,Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19,Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19,COMPLETED,,PHASE2,185.0,ACTUAL,Apeiron Biologics,,2.0,,,f,,,,,t,f,,,,,,,,,,,2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,INDUSTRY,,,,,,,2020,1.0
NCT04525885,,2020-08-18,2023-09-06,,2024-01-11,2020-08-24,2020-08-25,ACTUAL,2023-09-06,2023-10-02,ACTUAL,,,,2024-01-11,2024-01-12,ACTUAL,2019-05-17,ACTUAL,2019-05-17,2024-01,2024-01-31,2022-09-15,ACTUAL,2022-09-15,2022-09-15,ACTUAL,2022-09-15,,INTERVENTIONAL,,,A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)-China Extension,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN030)",COMPLETED,,PHASE3,161.0,ACTUAL,Merck Sharp & Dohme LLC,,3.0,,,,,,,t,t,f,,,,,,,,http://engagezone.msd.com/ds_documentation.php,YES,http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf,2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,INDUSTRY,,,,,,,2022,1.0
NCT04927169,,2021-06-14,,,2024-04-10,2021-06-14,2021-06-15,ACTUAL,,,,,,,2024-04-10,2024-04-12,ACTUAL,2021-03-01,ACTUAL,2021-03-01,2024-04,2024-04-30,2022-03-30,ACTUAL,2022-03-30,2021-12-31,ACTUAL,2021-12-31,,INTERVENTIONAL,ILIAD-7-BRA,,InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection (Brazil Cohort),Recombinant Human InterLeukin-7 (CYT107) to Improve Clinical Outcomes in Lymphopenic PAtients With COVID-19 Infection - ILIAD 7 Trial Brazil Cohort,TERMINATED,,PHASE2,4.0,ACTUAL,Revimmune,,2.0,,POOR ACCRUAL,f,,,,t,t,f,,,t,,,,,,NO,Publication,2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,INDUSTRY,,,,,,,2022,0.0
NCT03976648,,2019-06-04,2022-02-16,,2022-03-16,2019-06-04,2019-06-06,ACTUAL,2022-02-16,2022-03-15,ACTUAL,,,,2022-03-16,2022-03-29,ACTUAL,2019-07-18,ACTUAL,2019-07-18,2022-03,2022-03-31,2021-04-13,ACTUAL,2021-04-13,2021-04-13,ACTUAL,2021-04-13,,INTERVENTIONAL,,The open-label extension (OLE) full analysis set (FAS) was defined as all participants who had at least one intake of investigational product in the OLE study.,A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis,"A Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Orally Administered GLPG1690 in Subjects With Systemic Sclerosis",TERMINATED,,PHASE2,31.0,ACTUAL,Galapagos NV,"The benefit-risk profile no longer supports continuing the studies. Therefore, the study was terminated.",2.0,,The benefit-risk profile no longer supports continuing the studies,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,INDUSTRY,,,,,,,2021,0.0
NCT03672097,,2018-09-13,2021-09-08,,2021-10-15,2018-09-13,2018-09-14,ACTUAL,2021-10-15,2021-11-12,ACTUAL,,,,2021-10-15,2021-11-12,ACTUAL,2018-10-16,ACTUAL,2018-10-16,2021-10,2021-10-31,2020-08-19,ACTUAL,2020-08-19,2020-08-19,ACTUAL,2020-08-19,,INTERVENTIONAL,,The baseline demographics were reported from the Safety Population.,Prasugrel Switching Study in Patients With Acute Coronary Syndrome (ACS) Who Underwent Percutaneous Coronary Intervention (PCI),"Phase IV, Non-comparative, Open Label, Multicenter, 28-Week Switching Study of Prasugrel Maintenance Dose From Clopidogrel in Patients With Acute Coronary Syndrome (ACS) Who Underwent a Percutaneous Coronary Intervention (PCI) in Taiwan",COMPLETED,,PHASE4,204.0,ACTUAL,Daiichi Sankyo,,1.0,,,f,,,,f,f,f,,,,,,"Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.","Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.",https://vivli.org/ourmember/daiichi-sankyo/,YES,"De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,INDUSTRY,,,,,,,2020,1.0
NCT03800420,,2019-01-07,2021-08-04,,2022-02-23,2019-01-08,2019-01-11,ACTUAL,2022-02-23,2022-03-21,ACTUAL,,,,2022-02-23,2022-03-21,ACTUAL,2019-04-22,ACTUAL,2019-04-22,2022-02,2022-02-28,2020-07-31,ACTUAL,2020-07-31,2020-05-18,ACTUAL,2020-05-18,,INTERVENTIONAL,,subjects who were randomized,Efficacy and Safety of BBT-401-1S in Ulcerative Colitis,"A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of BBT-401-1S in Patients With Active Ulcerative Colitis",TERMINATED,,PHASE2,16.0,ACTUAL,"Bridge Biotherapeutics, Inc.",,2.0,,to carry out the rest of the study with new CRO and modified protocol as a multi-regional study.,f,,,,,t,f,,,,,,,,,,,2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,INDUSTRY,,,,,,,2020,0.0
NCT04801056,,2021-03-11,,,2022-05-11,2021-03-15,2021-03-16,ACTUAL,,,,,,,2022-05-11,2022-05-18,ACTUAL,2021-06-01,ACTUAL,2021-06-01,2022-05,2022-05-31,2021-09-01,ACTUAL,2021-09-01,2021-09-01,ACTUAL,2021-09-01,,INTERVENTIONAL,,,Study of TB006 in Outpatient Patients With Mild to Moderate COVID-19,"A Phase I, First-In-Human, Randomized, Single Ascending Dose Study of TB006 in Outpatient Patients With Mild to Moderate COVID-19",WITHDRAWN,,PHASE1,0.0,ACTUAL,"TrueBinding, Inc.",,2.0,,Difficulty in patient recruitment and will start again if study population increases to allow study feasibility,,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,INDUSTRY,,,,,,,2021,0.0
NCT04119830,,2019-10-07,,,2022-01-24,2019-10-07,2019-10-08,ACTUAL,,,,,,,2022-01-24,2022-02-08,ACTUAL,2022-02-01,ESTIMATED,2022-02-01,2022-01,2022-01-31,2024-02-01,ESTIMATED,2024-02-01,2024-02-01,ESTIMATED,2024-02-01,,INTERVENTIONAL,,,Rintatolimod and Pembrolizumab for the Treatment of Refractory Metastatic or Unresectable Colorectal Cancer,A Phase IIa Study of Rintatolimod Plus Pembrolizumab in Refractory Metastatic Colorectal Cancer,WITHDRAWN,,PHASE2,0.0,ACTUAL,Roswell Park Cancer Institute,,1.0,,implementation issues,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,OTHER,,,,,,,2024,0.0
NCT04630353,,2020-10-23,,,2024-03-07,2020-11-10,2020-11-16,ACTUAL,,,,,,,2024-03-07,2024-03-12,ACTUAL,2021-07-28,ACTUAL,2021-07-28,2024-03,2024-03-31,2023-11-28,ACTUAL,2023-11-28,2023-11-28,ACTUAL,2023-11-28,,INTERVENTIONAL,,,A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer,A Phase 0 Trial of HB-201 for Subjects With Transoral Resectable Human Papillomavirus 16 Positive (HPV 16+) Oropharynx Cancer or With Locally Advanced Cervical Cancer Treated With Chemotherapy and Radiation,TERMINATED,,EARLY_PHASE1,10.0,ACTUAL,Hookipa Biotech GmbH,,2.0,,Sponsor decision.,f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,INDUSTRY,,,,,,,2023,0.0
NCT03566485,,2018-06-11,2021-06-10,,2021-08-10,2018-06-11,2018-06-25,ACTUAL,2021-08-10,2021-08-11,ACTUAL,,,,2021-08-10,2021-08-11,ACTUAL,2018-07-10,ACTUAL,2018-07-10,2021-08,2021-08-31,2020-12-10,ACTUAL,2020-12-10,2020-12-10,ACTUAL,2020-12-10,,INTERVENTIONAL,,,Atezolizumab and Cobimetinib or Idasanutlin in Participants With Stage IV or Unresectable Recurrent Estrogen Receptor Positive Breast Cancer,BRE 17107: A Phase Ib/II Trial of Atezolizumab (an Anti-PD-L1 Monoclonal Antibody) With Cobimetinib (a MEK1/2 Inhibitor) or Idasanutlin (an MDM2 Antagonist) in Metastatic ER+ Breast Cancer,TERMINATED,,PHASE1/PHASE2,12.0,ACTUAL,Vanderbilt-Ingram Cancer Center,,2.0,,Low accrual/Loss of funding,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 06:18:15.339859,2024-10-15 06:18:15.339859,OTHER,,,,,,,2020,0.0
NCT04344444,,2020-04-10,,,2022-01-05,2020-04-10,2020-04-14,ACTUAL,,,,,,,2022-01-05,2022-01-21,ACTUAL,2020-04-13,ACTUAL,2020-04-13,2020-08,2020-08-31,2022-01-05,ACTUAL,2022-01-05,2021-04-10,ACTUAL,2021-04-10,,INTERVENTIONAL,RCT,,Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease,Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease: A Randomized Clinical Trial,TERMINATED,,PHASE3,22.0,ACTUAL,LCMC Health,,3.0,,Lack of efficacy data from other studies,f,,,,f,t,f,,,f,,,,,,UNDECIDED,,2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,OTHER,,,,,,,2022,0.0
NCT04301284,,2020-03-06,,,2021-04-05,2020-03-09,2020-03-10,ACTUAL,,,,,,,2021-04-05,2021-04-08,ACTUAL,2021-06,ESTIMATED,2021-06-30,2021-04,2021-04-30,2022-12,ESTIMATED,2022-12-31,2022-11,ESTIMATED,2022-11-30,,INTERVENTIONAL,Synchrony-1,,Study of CAD-1883 for Spinocerebellar Ataxia,"Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of CAD-1883 in Adults With Spinocerebellar Ataxia (Synchrony-1)",WITHDRAWN,,PHASE2,0.0,ACTUAL,Cadent Therapeutics,,2.0,,"In January 2021 Novartis acquired Cadent Therapeutics. As part of a pipeline reassessment, the Synchrony-1 trial will not proceed as initially scheduled.",f,,,,f,t,f,,,,,,,,,NO,,2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,INDUSTRY,,,,,,,2022,0.0
NCT04605991,,2020-10-26,2023-02-03,,2023-02-03,2020-10-26,2020-10-28,ACTUAL,2023-02-03,2023-03-03,ACTUAL,,,,2023-02-03,2023-03-03,ACTUAL,2020-11-04,ACTUAL,2020-11-04,2023-02,2023-02-28,2022-02-04,ACTUAL,2022-02-04,2022-02-04,ACTUAL,2022-02-04,,INTERVENTIONAL,,All enrolled participants.,A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range),A Study of LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring,COMPLETED,,PHASE3,187.0,ACTUAL,Eli Lilly and Company,,1.0,,,f,,,,f,t,f,,,,,,"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.",A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.,https://vivli.org/,YES,Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.,2024-10-15 06:23:58.163208,2024-10-15 06:23:58.163208,INDUSTRY,,,,,,,2022,0.0
NCT03176537,,2017-06-01,,,2020-04-14,2017-06-01,2017-06-05,ACTUAL,,,,,,,2020-04-14,2020-04-16,ACTUAL,2017-05-01,ESTIMATED,2017-05-01,2020-04,2020-04-30,2020-12-31,ESTIMATED,2020-12-31,2020-12-31,ESTIMATED,2020-12-31,,INTERVENTIONAL,,,Periodontal Profile of Hypogonadic Men,"Clinical, Microbiologic and Immunologic Profile of the Periodontal Condition in Hypogonadic Men",WITHDRAWN,,PHASE4,0.0,ACTUAL,Universidade Federal do Paraná,,2.0,,No eligible participants for the RCT were found,f,,,,f,f,f,,,f,,,,,,NO,,2024-10-15 06:23:58.163208,2024-10-15 06:23:58.163208,OTHER,,,,,,,2020,0.0
NCT04784442,,2021-03-02,2023-07-26,,2024-05-09,2021-03-02,2021-03-05,ACTUAL,2023-07-26,2024-03-04,ACTUAL,,,,2024-05-09,2024-05-10,ACTUAL,2021-03-24,ACTUAL,2021-03-24,2024-05,2024-05-31,2022-05-17,ACTUAL,2022-05-17,2022-04-18,ACTUAL,2022-04-18,,INTERVENTIONAL,,"For the full analysis set (FAS), a total of 186 subjects (45 for the 60 mg group, 46 for the 120 mg group, and 48 for the 180 mg group were included in the ETC-1002 group, and 47 subjects were included in the placebo group).",A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia,"A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of ETC-1002 in Patients With Hypercholesterolemia",COMPLETED,,PHASE2,188.0,ACTUAL,"Otsuka Pharmaceutical Co., Ltd.",,4.0,,,f,,,,f,f,f,,,,,,"Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.",Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.,,YES,: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.,2024-10-15 06:23:58.163208,2024-10-15 06:23:58.163208,INDUSTRY,,,,,,,2022,1.0
NCT03449524,,2018-02-14,,,2020-08-06,2018-02-22,2018-02-28,ACTUAL,,,,,,,2020-08-06,2020-08-10,ACTUAL,2018-08-01,ACTUAL,2018-08-01,2020-08,2020-08-31,2020-08-05,ACTUAL,2020-08-05,2020-08-05,ACTUAL,2020-08-05,,INTERVENTIONAL,PAH,,PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH),"Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects With Pulmonary Arterial Hypertension",TERMINATED,,PHASE2,69.0,ACTUAL,"Complexa, Inc.",,3.0,,LOE,f,,,,f,t,f,,,,,,,,,UNDECIDED,,2024-10-15 06:23:58.163208,2024-10-15 06:23:58.163208,INDUSTRY,,,,,,,2020,0.0
NCT03614052,,2018-07-30,,,2020-01-29,2018-07-30,2018-08-03,ACTUAL,,,,,,,2020-01-29,2020-01-31,ACTUAL,2018-06-01,ACTUAL,2018-06-01,2020-01,2020-01-31,2020-01-26,ACTUAL,2020-01-26,2020-01-26,ACTUAL,2020-01-26,,INTERVENTIONAL,,,Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy,Efectividad de la Tamsulosina Como Tratamiento Adyuvante Previo a Ureterolitotomia Endoscopica,TERMINATED,,PHASE4,14.0,ACTUAL,Pontificia Universidad Catolica de Chile,,2.0,,Problems with the number of participants,f,,,,f,f,f,,,,,,,,,,,2024-10-15 06:23:58.163208,2024-10-15 06:23:58.163208,OTHER,,,,,,,2020,0.0
NCT03727724,,2018-09-03,,,2023-10-17,2018-10-31,2018-11-01,ACTUAL,,,,,,,2023-10-17,2023-10-18,ACTUAL,2018-12-04,ACTUAL,2018-12-04,2023-10,2023-10-31,2022-09-06,ACTUAL,2022-09-06,2022-09-06,ACTUAL,2022-09-06,,INTERVENTIONAL,AFACET,,Afatinib and Cetuximab in Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Positive Non-small-cell Lung Cancer,Phase II Single Arm Study of Afatinib in Combination With Cetuximab in EGFR Exon 20 Insertion Positive Non-small-cell Lung Cancer,COMPLETED,,PHASE2,37.0,ACTUAL,The Netherlands Cancer Institute,,1.0,,,f,,,,f,f,f,,,,,,,,,UNDECIDED,,2024-10-15 06:23:58.163208,2024-10-15 06:23:58.163208,OTHER,,,,,,,2022,1.0
NCT04044170,,2019-08-01,,,2020-11-16,2019-08-01,2019-08-05,ACTUAL,,,,,,,2020-11-16,2020-11-17,ACTUAL,2019-07-30,ACTUAL,2019-07-30,2020-11,2020-11-30,2020-04-13,ACTUAL,2020-04-13,2020-04-13,ACTUAL,2020-04-13,,INTERVENTIONAL,,,Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation,A Phase 2 Study of Poziotinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With EGFR or HER2 Exon 20 Mutation in China and Korea,TERMINATED,,PHASE2,5.0,ACTUAL,Hanmi Pharmaceutical Company Limited,,1.0,,Study termination by the Sponsor,f,,,,,f,f,,,,,,,,,,,2024-10-15 06:23:58.163208,2024-10-15 06:23:58.163208,INDUSTRY,,,,,,,2020,0.0
NCT03079102,,2017-01-05,2021-11-30,2021-05-22,2022-03-27,2017-03-07,2017-03-14,ACTUAL,2022-03-27,2022-04-25,ACTUAL,2022-03-27,2022-04-25,ACTUAL,2022-03-27,2022-04-25,ACTUAL,2017-08-26,ACTUAL,2017-08-26,2022-03,2022-03-31,2020-06-02,ACTUAL,2020-06-02,2020-05-22,ACTUAL,2020-05-22,,INTERVENTIONAL,iNOOHCA,,Inhaled Nitric Oxide After Out-of-Hospital Cardiac Arrest,Inhaled Nitric Oxide After Out-of-Hospital Cardiac Arrest,TERMINATED,,PHASE2,57.0,ACTUAL,University of Pittsburgh,Planned Echocardiogram data was not able to be collected due to technical and feasibility constraints.~Laser speckle contrast imaging data still requires validation and is therefore not reported.~CPC-extended data was incomplete across many domains and therefore is not reported.,2.0,,Slow enrollment and planned change of institution by PI,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:23:58.163208,2024-10-15 06:23:58.163208,OTHER,,,,,,,2020,0.0
NCT02780128,,2016-05-11,,,2023-11-27,2016-05-19,2016-05-23,ESTIMATED,,,,,,,2023-11-27,2023-11-29,ACTUAL,2016-07,ACTUAL,2016-07-31,2023-11,2023-11-30,2022-08,ACTUAL,2022-08-31,2022-08,ACTUAL,2022-08-31,,INTERVENTIONAL,NEPENTHE,,Next Generation Personalized Neuroblastoma Therapy,Next Generation Personalized Neuroblastoma Therapy (The NEPENTHE Trial),TERMINATED,,PHASE1,66.0,ACTUAL,Children's Hospital of Philadelphia,,2.0,,"The goals of Part 1 (molecular screening) were met, but lack of therapies to match molecular aberrations made Part 2 (treatment) no longer feasible.",f,,,,t,,,,,,,,,,,,,2024-10-15 06:23:58.163208,2024-10-15 06:23:58.163208,OTHER,,,,,,,2022,0.0
NCT04145219,,2019-10-11,2024-03-22,,2024-06-11,2019-10-28,2019-10-30,ACTUAL,2024-06-11,2024-06-12,ACTUAL,,,,2024-06-11,2024-06-12,ACTUAL,2019-10-12,ACTUAL,2019-10-12,2024-06,2024-06-30,2023-04-21,ACTUAL,2023-04-21,2023-04-01,ACTUAL,2023-04-01,,INTERVENTIONAL,MATIC,All randomized and treated participants,House Dust Mite Allergy Trial In Children,A One-year Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Children (5-11 Years of Age) With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma,COMPLETED,,PHASE3,1460.0,ACTUAL,ALK-Abelló A/S,,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:23:58.163208,2024-10-15 06:23:58.163208,INDUSTRY,,,,,,,2023,1.0
NCT04139993,,2019-10-22,,,2023-10-02,2019-10-23,2019-10-25,ACTUAL,,,,,,,2023-10-02,2023-10-04,ACTUAL,2020-08-31,ACTUAL,2020-08-31,2023-10,2023-10-31,2023-01-11,ACTUAL,2023-01-11,2023-01-11,ACTUAL,2023-01-11,,INTERVENTIONAL,,,RBX7455 Before Surgery for the Treatment of Operable Breast Cancer,"A Pilot Trial of Preoperative Oral Microbiota-Based Investigational New Drug, RBX7455 to Target Immune Response in Patients With Operable Stage I-III Breast Cancer",TERMINATED,,PHASE1,3.0,ACTUAL,Mayo Clinic,,1.0,,poor accrual,,,,,t,t,f,,,,,,,,,,,2024-10-15 06:23:58.163208,2024-10-15 06:23:58.163208,OTHER,,,,,,,2023,0.0
NCT02043899,,2014-01-21,2021-04-09,,2021-05-27,2014-01-21,2014-01-23,ESTIMATED,2021-05-27,2021-06-21,ACTUAL,,,,2021-05-27,2021-06-21,ACTUAL,2014-02,ACTUAL,2014-02-28,2021-05,2021-05-31,2020-10-15,ACTUAL,2020-10-15,2020-10-15,ACTUAL,2020-10-15,,INTERVENTIONAL,,,A Phase I/II Study of [124I]mIBG PET/CT in Neuroblastoma,A Cancer Research UK Phase I/II Study to Compare [124I]Meta-Iodobenzylguanidine (mIBG) Positron Emission Tomography/Computerised Tomography (PET/CT) to [123I]mIBG Imaging in Patients With Metastatic Neuroblastoma,COMPLETED,,PHASE1/PHASE2,36.0,ACTUAL,Cancer Research UK,An exact one-sided binomial test of the null hypothesis: p ≤90% was performed using α=0.05 on the \[124I\]mIBG PET/CT imaging assessments with SIOPEN consensus scores.,1.0,,,f,,,,f,f,f,,,,,,,,,NO,,2024-10-15 06:23:58.163208,2024-10-15 06:23:58.163208,OTHER,,,,,,,2020,1.0
NCT04491604,,2020-07-22,2022-12-08,,2023-01-25,2020-07-27,2020-07-29,ACTUAL,2023-01-25,2023-02-17,ACTUAL,,,,2023-01-25,2023-02-17,ACTUAL,2020-08-17,ACTUAL,2020-08-17,2022-12,2022-12-31,2022-01-14,ACTUAL,2022-01-14,2021-10-29,ACTUAL,2021-10-29,,INTERVENTIONAL,GEM-3,Safety Population,Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB,"A Phase III Efficacy and Safety Study of Beremagene Geperpavec (B-VEC, Previously KB103) for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)",COMPLETED,,PHASE3,31.0,ACTUAL,"Krystal Biotech, Inc.",,2.0,,,f,,,,t,t,f,,,,,,,,,NO,,2024-10-15 06:23:58.163208,2024-10-15 06:23:58.163208,INDUSTRY,,,,,,,2022,1.0
NCT03909594,,2019-04-04,,,2021-10-04,2019-04-08,2019-04-10,ACTUAL,,,,,,,2021-10-04,2021-10-11,ACTUAL,2022-01-01,ESTIMATED,2022-01-01,2021-10,2021-10-31,2023-12-31,ESTIMATED,2023-12-31,2023-12-31,ESTIMATED,2023-12-31,,INTERVENTIONAL,,,Bubiket Study: Ultrasound Guided Fascia Iliaca Nerve Block With Bupivacaine and Adjuvant Ketamine vs. Bupivacaine Alone,Ultrasound Guided Fascia Iliaca Nerve Block With Bupivacaine and Adjuvant Ketamine vs. Bupivacaine Alone in Patients With Hip or Femur Fracture: a Double Blind Randomized Clinical Trial (BupiKet),WITHDRAWN,,PHASE4,0.0,ACTUAL,Maimonides Medical Center,,2.0,,The COVID Pandemic delayed start of study and currently the investigators are not interested in conducting the study.,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,OTHER,,,,,,,2023,0.0
NCT03836001,,2019-02-07,2022-11-30,,2023-01-21,2019-02-07,2019-02-11,ACTUAL,2022-11-30,2022-12-23,ACTUAL,,,,2023-01-21,2023-02-14,ACTUAL,2019-04-18,ACTUAL,2019-04-18,2023-01,2023-01-31,2022-06-24,ACTUAL,2022-06-24,2021-12-06,ACTUAL,2021-12-06,,INTERVENTIONAL,,,A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa,A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa,COMPLETED,,PHASE2,28.0,ACTUAL,Stanford University,"The primary limitation of the study is the small sample size due to the rarity of EB, the COVID-19 pandemic-related disruptions, and limited drug availability.",2.0,,,f,,,,f,t,f,,,f,,,,,,NO,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,OTHER,,,,,,,2022,1.0
NCT04625517,,2020-11-04,2023-06-02,,2023-10-10,2020-11-10,2020-11-12,ACTUAL,2023-10-10,2023-10-12,ACTUAL,,,,2023-10-10,2023-10-12,ACTUAL,2020-01-22,ACTUAL,2020-01-22,2023-10,2023-10-31,2022-06-15,ACTUAL,2022-06-15,2022-06-15,ACTUAL,2022-06-15,,INTERVENTIONAL,,,Performance of Contrast-Enhanced Spectral Mammography to Assess Neoadjuvant Chemotherapy Response (CEDM),Performance of Contrast-Enhanced Spectral Mammography to Assess Neoadjuvant Chemotherapy Response (CEDM),TERMINATED,,PHASE4,6.0,ACTUAL,University of Texas Southwestern Medical Center,,1.0,,Low enrollment,f,,,,t,t,f,,,t,,,,,,,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,OTHER,,,,,,,2022,0.0
NCT03823131,,2019-01-28,2023-03-20,,2023-04-17,2019-01-28,2019-01-30,ACTUAL,2023-04-17,2023-05-09,ACTUAL,,,,2023-04-17,2023-05-09,ACTUAL,2019-05-02,ACTUAL,2019-05-02,2023-04,2023-04-30,2022-07-31,ACTUAL,2022-07-31,2022-07-31,ACTUAL,2022-07-31,,INTERVENTIONAL,,The safety and efficacy analysis population is defined as all enrolled subjects who received at least one dose of study treatment.,"Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat","The Trifecta Study: Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat",TERMINATED,,PHASE2,14.0,ACTUAL,"University of California, San Francisco",The study closed earlier than expected during enrollment into Arm A. Arm B and Arm C were never opened to accrual.,3.0,,Treatment Ineffective,,,,,t,t,t,t,,f,,,,,,NO,,2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,OTHER,,,,,,,2022,0.0
NCT04346355,,2020-04-12,,,2020-06-18,2020-04-14,2020-04-15,ACTUAL,,,,,,,2020-06-18,2020-06-22,ACTUAL,2020-03-31,ACTUAL,2020-03-31,2020-06,2020-06-30,2020-06-06,ACTUAL,2020-06-06,2020-06-06,ACTUAL,2020-06-06,,INTERVENTIONAL,,,Efficacy of Early Administration of Tocilizumab in COVID-19 Patients,An Open-label Randomized Multicenter Study to Evaluate the Efficacy of Early Administration of Tocilizumab (TCZ) in Patients With COVID-19 Pneumonia,TERMINATED,,PHASE2,126.0,ACTUAL,Azienda Unità Sanitaria Locale Reggio Emilia,,2.0,,Based on interim analysis for futility and given an enrolment rate almost nil,f,,,,t,f,f,,,f,,,,,,,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,OTHER_GOV,,,,,,,2020,0.0
NCT04345367,,2020-03-27,2022-06-09,,2022-06-09,2020-04-10,2020-04-14,ACTUAL,2022-06-09,2022-07-08,ACTUAL,,,,2022-06-09,2022-07-08,ACTUAL,2020-06-11,ACTUAL,2020-06-11,2022-06,2022-06-30,2021-07-13,ACTUAL,2021-07-13,2021-07-13,ACTUAL,2021-07-13,,INTERVENTIONAL,,Safety Analysis Set comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.,Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy,"A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED MULTI-CENTER STUDY ASSESSING THE EFFICACY AND SAFETY OF ABROCITINIB COMPARED WITH DUPILUMAB IN ADULT PARTICIPANTS ON BACKGROUND TOPICAL THERAPY WITH MODERATE TO SEVERE ATOPIC DERMATITIS",COMPLETED,,PHASE3,727.0,ACTUAL,Pfizer,,2.0,,,f,,,,t,t,t,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,INDUSTRY,,,,,,,2021,1.0
NCT03801031,,2019-01-09,2022-10-14,,2022-11-10,2019-01-09,2019-01-11,ACTUAL,2022-11-10,2022-12-06,ACTUAL,,,,2022-11-10,2022-12-06,ACTUAL,2019-06-06,ACTUAL,2019-06-06,2022-11,2022-11-30,2021-11-03,ACTUAL,2021-11-03,2021-11-03,ACTUAL,2021-11-03,,INTERVENTIONAL,,,Sexual Dysfunction in Gynecologic Oncology Patients,Sexual Dysfunction in Gynecologic Oncology Patients,TERMINATED,,PHASE4,4.0,ACTUAL,University of Iowa,This study stopped accrual early due to unmet targeted accrual goals with 4 subjects accrued out of 120 planned.,2.0,,Slow accrual,f,,,,t,t,f,,,f,,,,,,NO,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,OTHER,,,,,,,2021,0.0
NCT03867370,,2019-03-01,,,2023-11-24,2019-03-05,2019-03-08,ACTUAL,,,,,,,2023-11-24,2023-11-29,ACTUAL,2019-04-26,ACTUAL,2019-04-26,2023-11,2023-11-30,2023-08-08,ACTUAL,2023-08-08,2023-08-08,ACTUAL,2023-08-08,,INTERVENTIONAL,,,Toripalimab in Combination With Lenvatinib as Neoadjuvant Therapy in Resectable Hepatocellular Carcinoma,"A Phase Ib/II, Open-Label, Multi-Center Study Evaluating the Efficacy and Safety of Neoadjuvant Toripalimab Injection (JS001) or Toripalimab in Combination With Lenvatinib for Patients With Resectable Hepatocellular Carcinoma (HCC)",TERMINATED,,PHASE1/PHASE2,40.0,ACTUAL,"Shanghai Junshi Bioscience Co., Ltd.",,3.0,,"Enrollment is over, the study was completed",f,,,,,f,f,,,,,,,,,,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,OTHER,,,,,,,2023,0.0
NCT04129151,,2019-10-14,2024-04-24,,2024-07-31,2019-10-15,2019-10-16,ACTUAL,2024-06-19,2024-07-17,ACTUAL,,,,2024-07-31,2024-08-01,ACTUAL,2019-12-05,ACTUAL,2019-12-05,2024-07,2024-07-31,2022-12-15,ACTUAL,2022-12-15,2022-12-15,ACTUAL,2022-12-15,,INTERVENTIONAL,,,Palbociclib + Ganitumab In Ewing Sarcoma,Phase 2 Trial of Palbociclib and Ganitumab in Patients With Relapsed or Refractory Ewing Sarcoma,TERMINATED,,PHASE2,10.0,ACTUAL,Dana-Farber Cancer Institute,The study terminated before full accrual.,1.0,,The study closed early due to discontinuation of ganitumab supply.,f,,,,t,t,f,,,,,,Data can be shared no earlier than 1 year following the date of publication,Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu,,YES,The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: contact Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,OTHER,,,,,,,2022,0.0
NCT03629275,,2018-07-23,,,2021-08-12,2018-08-10,2018-08-14,ACTUAL,,,,,,,2021-08-12,2021-08-13,ACTUAL,2018-08-31,ACTUAL,2018-08-31,2021-08,2021-08-31,2021-03-02,ACTUAL,2021-03-02,2020-09-09,ACTUAL,2020-09-09,,INTERVENTIONAL,PISCES III,,Investigation of Neural Stem Cells in Ischemic Stroke,"A Randomized, Placebo-Controlled Study of the Efficacy and Safety of Intracerebral Stem Cells (CTX0E03) in Subjects With Disability Following an Ischemic Stroke",TERMINATED,,PHASE2,15.0,ACTUAL,ReNeuron Limited,,2.0,,Strategic decision to progress stroke disability programme through regional partnerships,f,,,,t,t,t,t,,,,,,,,,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,INDUSTRY,,,,,,,2021,0.0
NCT03364270,,2017-12-01,2021-08-11,,2022-07-19,2017-12-01,2017-12-06,ACTUAL,2022-07-18,2022-07-20,ACTUAL,,,,2022-07-19,2022-08-09,ACTUAL,2018-10-10,ACTUAL,2018-10-10,2022-07,2022-07-31,2020-05-31,ACTUAL,2020-05-31,2020-02-28,ACTUAL,2020-02-28,,INTERVENTIONAL,K5-C200,,TRACER [F-18] RDG-K5 Carotid Plaque Imaging Study,"An Exploratory, Phase II, Open Label, Single-Center, Non-Randomized Study Of [F-18] RGD-K5 Positron Emission Tomography (PET) In Participants With Carotid Artery Stenosis",COMPLETED,,PHASE2,6.0,ACTUAL,Cedars-Sinai Medical Center,Small sample size Differences in the time between imaging and symptoms of stroke or transient ischemic attack,1.0,,,f,,,,f,t,f,,,,,,,,,,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,OTHER,,,,,,,2020,1.0
NCT05065411,,2021-09-21,,,2024-02-23,2021-09-22,2021-10-04,ACTUAL,,,,,,,2024-02-23,2024-02-26,ACTUAL,2022-04-11,ACTUAL,2022-04-11,2024-02,2024-02-29,2024-01-09,ACTUAL,2024-01-09,2023-10-19,ACTUAL,2023-10-19,,INTERVENTIONAL,VERU-024,,Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer,P3 Efficacy Evaluation of Enobosarm in Combo With Abemaciclib Compared to Estrogen Blocking Agent for 2nd Line Treatment of ER+HER2- MBC in Patients Who Have Shown Previous Disease Progression on an Estrogen Blocking Agent Plus Palbociclib,TERMINATED,,PHASE3,5.0,ACTUAL,Veru Inc.,,2.0,,Business decision,f,,,,t,t,f,,,,,,,,,UNDECIDED,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,INDUSTRY,,,,,,,2024,0.0
NCT03526588,,2018-04-27,,,2024-07-09,2018-05-15,2018-05-16,ACTUAL,,,,,,,2024-07-09,2024-07-11,ACTUAL,2018-08-01,ACTUAL,2018-08-01,2024-07,2024-07-31,2024-07-01,ACTUAL,2024-07-01,2022-07-01,ACTUAL,2022-07-01,,INTERVENTIONAL,,,Umbilical Cord Blood Mononuclear Cells for Hypoxic Neurologic Injury in Infants With Congenital Diaphragmatic Hernia (CDH),Umbilical Cord Blood Mononuclear Cells for Hypoxic Neurologic Injury in Infants With Congenital Diaphragmatic Hernia (CDH),TERMINATED,,PHASE1,3.0,ACTUAL,"The University of Texas Health Science Center, Houston",,1.0,,"Competing randomized trial of an experimental therapy limited initial enrollment. The trial was completed, published, and the experimental therapy became broadly desired. Given this, the investigators felt it best to terminate this competing study.",f,,,,t,t,f,,,,,,,,,,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,OTHER,,,,,,,2024,0.0
NCT03615040,,2018-05-04,2022-01-06,,2022-05-24,2018-07-30,2018-08-03,ACTUAL,2022-05-23,2022-05-24,ACTUAL,,,,2022-05-24,2022-06-21,ACTUAL,2018-10-11,ACTUAL,2018-10-11,2020-06,2020-06-30,2020-12-31,ACTUAL,2020-12-31,2020-05-29,ACTUAL,2020-05-29,,INTERVENTIONAL,COPD-ST2OP,,Anti-ST2 (MSTT1041A) in COPD (COPD-ST2OP),A Randomised Placebo-controlled Trial of Anti-ST2 in COPD (COPD-ST2OP),COMPLETED,,PHASE2,81.0,ACTUAL,University of Leicester,"* Small sample size (n=81) at a single site, therefore not powered to detect a reduction in exacerbation frequency that was observed.~* Participants were required to have had a minimum of 2 exacerbations in the previous 12 months, so the findings are not representative for a wider clinical population.~* In response to COVID-19, collection of secondary/exploratory outcomes were reduced, with spirometry and sputum induction discontinued.",2.0,,,,,,,t,t,f,,,t,,,,,,NO,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,OTHER,,,,,,,2020,1.0
NCT03630770,,2018-07-25,2021-11-02,,2022-03-10,2018-08-09,2018-08-15,ACTUAL,2022-03-10,2022-06-14,ACTUAL,,,,2022-03-10,2022-06-14,ACTUAL,2014-06-05,ACTUAL,2014-06-05,2022-03,2022-03-31,2021-11-02,ACTUAL,2021-11-02,2017-11-29,ACTUAL,2017-11-29,,INTERVENTIONAL,,,Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida,Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida,COMPLETED,,PHASE1,12.0,ACTUAL,Women and Infants Hospital of Rhode Island,,2.0,,,f,,,,f,t,f,,,,,,,,,NO,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,OTHER,,,,,,,2021,1.0
NCT05621525,,2022-11-10,,,2024-06-24,2022-11-10,2022-11-18,ACTUAL,,,,,,,2024-06-24,2024-06-25,ACTUAL,2022-10-18,ACTUAL,2022-10-18,2024-06,2024-06-30,2024-03-29,ACTUAL,2024-03-29,2024-03-29,ACTUAL,2024-03-29,,INTERVENTIONAL,,,Phase I Study of the BBP-398 in Patients With Advance Solid Tumors,"A Phase I, Open Label, Dose Escalation and Expansion, Two- Part Study of SHP-2 Inhibitor BBP-398 to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-cancer Activity in Chinese Subjects With Advanced Solid Tumors",TERMINATED,,PHASE1,7.0,ACTUAL,LianBio LLC,,1.0,,Business reason,f,,,,f,f,f,,,,,,,,,,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,INDUSTRY,,,,,,,2024,0.0
NCT03642132,,2018-07-13,2022-12-06,,2023-03-10,2018-08-20,2018-08-22,ACTUAL,2023-03-10,2023-04-06,ACTUAL,,,,2023-03-10,2023-04-06,ACTUAL,2018-07-19,ACTUAL,2018-07-19,2023-03,2023-03-31,2021-12-22,ACTUAL,2021-12-22,2021-12-22,ACTUAL,2021-12-22,,INTERVENTIONAL,,"The baseline analysis population included all randomized participants who received at least 1 dose of study drug (avelumab, talazoparib, bevacizumab, carboplatin, paclitaxel).",Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100),"A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB IN COMBINATION WITH CHEMOTHERAPY FOLLOWED BY MAINTENANCE THERAPY OF AVELUMAB IN COMBINATION WITH THE POLY (ADENOSINE DIPHOSPHATE [ADP]-RIBOSE) POLYMERASE (PARP) INHIBITOR TALAZOPARIB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OVARIAN CANCER (JAVELIN OVARIAN PARP100)",TERMINATED,,PHASE3,79.0,ACTUAL,Pfizer,"As of 19 March 2019, the sponsor decided to stop enrollment/randomization in the study. A total of 104 participants were screened and 79 participants completed screening and randomized in the study before study discontinuation. As only 11% projected enrollment was met at the time of enrollment stop, the original study endpoints are no longer applicable and/or feasible; only the Safety, PK and Immunogenicity Analysis were done and these data are included in this report.",3.0,,"Phase 3 B9991010 study was stopped due to futility of efficacy at interim analysis on 21Dec2018, and approvals of PARP inhibitors in front-line maintenance setting, Pfizer decided stopping enrollment in the B9991030 study on 19Mar2019.",f,,,,t,t,f,,,,,,,,https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests,YES,"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,INDUSTRY,,,,,,,2021,0.0
NCT03631641,,2018-08-13,2022-11-09,,2024-06-27,2018-08-13,2018-08-15,ACTUAL,2024-06-27,2024-07-01,ACTUAL,,,,2024-06-27,2024-07-01,ACTUAL,2018-10-04,ACTUAL,2018-10-04,2024-06,2024-06-30,2021-01-25,ACTUAL,2021-01-25,2021-01-25,ACTUAL,2021-01-25,,INTERVENTIONAL,,,Nivolumab in Preventing Colon Adenomas in Participants With Lynch Syndrome and a History of Partial Colectomy,A Phase II Study of PD-1 Inhibition for the Prevention of Colon Adenomas in Patients With Lynch Syndrome and a History of Partial Colectomy,TERMINATED,,PHASE2,3.0,ACTUAL,Ohio State University Comprehensive Cancer Center,Trial stopped early due to withdrawal of pharmaceutical sponsor support,1.0,,Sponsor decision,,,,,t,t,f,,,,,,,,,NO,,2024-10-17 02:29:59.152132,2024-10-17 02:29:59.152132,OTHER,,,,,,,2021,0.0
NCT02543749,,2015-08-25,,,2023-02-07,2015-09-04,2015-09-07,ESTIMATED,,,,,,,2023-02-07,2023-02-09,ACTUAL,2014-07,,2014-07-31,2023-02,2023-02-28,2022-07,ACTUAL,2022-07-31,2022-07,ACTUAL,2022-07-31,,INTERVENTIONAL,,,DC Vaccination in CML,Dendritic Cells as Autologous Vaccine in Patients With Chronic Myeloid Leukemia,TERMINATED,,PHASE1/PHASE2,1.0,ACTUAL,"Charite University, Berlin, Germany",,1.0,,,f,,,,f,,,,,,,,,,,,,2024-10-15 06:29:28.751562,2024-10-15 06:29:28.751562,OTHER,,,,,,,2022,0.0